APPROVED

DRUG
PRODUCTS

WITH

THERAPEUTIC
EQUIVALENCE
EVALUATIONS

32nd EDITION
THE PRODUCTS IN THIS LIST HAVE BEEN APPROVED UNDER SECTION 505 OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT.
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH
OFFICE OF PHARMACEUTICAL SCIENCE OFFICE OF GENERIC DRUGS

2012

APPROVED DRUG PRODUCTS

with
THERAPEUTIC EQUIVALENCE EVALUATIONS

The products in this list have been approved under section 505 of the Federal Food, Drug, and Cosmetic Act. This volume is current through December 31, 2011.

32nd EDITION

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH
OFFICE OF PHARMACEUTICAL SCIENCE
OFFICE OF GENERIC DRUGS

2012

FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH APPROVED DRUG PRODUCTS with Therapeutic Equivalence Evaluations

CONTENTS
PAGE

PREFACE TO THIRTY SECOND EDITION

2 2.1 2.2 2.3

..................iv
HOW TO USE THE DRUG PRODUCTS LISTS ..............................................................2-1
Key Sections for Using the Drug Product Lists ........2-1
Drug Product Illustration ......2-3
Therapeutic Equivalence Evaluations Illustration ....2-4

DRUG PRODUCT LISTS

Prescription Drug Product List .....3-1
OTC Drug Product List ..4-1
Drug Products with Approval under Section 505 of the Act Administered
by the Center for Biologics Evaluation and Research List ........5-1
Discontinued Drug Product List .......6-1
Orphan Products Designations and Approvals List .....7-1
Drug Products Which Must Demonstrate in vivo Bioavailability
Only if Product Fails to Achieve Adequate Dissolution ....8-1
APPENDICES A. Product Name Index .......A-1 B. Product Name Index Listed by Applicant .....B-1
C. Uniform Terms .........C-1
PATENT AND EXCLUSIVITY INFORMATION ADDENDUM .............AD1
A. Patent and Exclusivity Lists .......ADA1 B. Patent and Exclusivity Terms ........ADB1

iii

FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH
APPROVED DRUG PRODUCTS
with
Therapeutic Equivalence Evaluations

PREFACE TO THIRTY SECOND EDITION

The publication, Approved Drug Products with Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book), identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the Act). Drugs on the market approved only on the basis of safety (covered by the ongoing Drug Efficacy Study Implementation [DESI] review [e.g., Donnatal Tablets and Librax Capsules] or pre-1938 drugs [e.g., Phenobarbital Tablets]) are not included in this publication. The main criterion for the inclusion of any product is that the product is the subject of an application with an effective approval that has not been withdrawn for safety or efficacy reasons. Inclusion of products on the List is independent of any current regulatory action through administrative or judicial means against a drug product. In addition, the List contains therapeutic equivalence evaluations for approved multisource prescription drug products. These evaluations have been prepared to serve as public information and advice to state health agencies, prescribers, and pharmacists to promote public education in the area of drug product selection and to foster containment of health care costs. Therapeutic equivalence evaluations in this publication are not official FDA actions affecting the legal status of products under the Act. Background of the Publication. To contain drug costs, virtually every state has adopted laws and/or regulations that encourage the substitution of drug products. These state laws generally require either that substitution be limited to drugs on a specific list (the positive formulary approach) or that it be permitted for all drugs except those prohibited by a particular list (the negative formulary approach). Because of the number of requests in the late 1970s for FDA assistance in preparing both positive and negative formularies, it became apparent that FDA could not serve the needs of each state on an individual basis. The Agency also recognized that providing a single list based on common criteria would be preferable to evaluating drug products on the basis of differing definitions and criteria in various state laws. As a result, on May 31, 1978, the Commissioner of the Food and Drug Administration sent a letter to officials of each state stating FDA's intent to provide a list of all prescription drug products that are approved by FDA for safety and effectiveness, along with therapeutic equivalence determinations for multisource prescription products. The List was distributed as a proposal in January l979. It included only currently marketed prescription drug products approved by FDA through new drug applications (NDAs) and abbreviated new drug applications (ANDAs) under the provisions of Section 505 of the Act. The therapeutic equivalence evaluations in the List reflect FDA's application of specific criteria to the multisource prescription drug products on the List approved under Section 505 of the Act. These evaluations are presented in the form of code letters that indicate the basis for the evaluation made. An explanation of the code appears in the Introduction. A complete discussion of the background and basis of FDA's therapeutic equivalence evaluation policy was published in the Federal Register on January 12, 1979 (44 FR 2932). The final rule, which includes FDA's responses to the public comments on the proposal, was published in the Federal Register

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on October 31, 1980 (45 FR 72582). The first publication, October 1980, of the final version of the List incorporated appropriate corrections and additions. Each subsequent edition has included the new approvals and made appropriate changes in data. On September 24, 1984, the President signed into law the Drug Price Competition and Patent Term Restoration Act (1984 Amendments). The 1984 Amendments require that FDA, among other things, make publicly available a list of approved drug products with monthly supplements. The Approved Drug Products with Therapeutic Equivalence Evaluations publication and its monthly Cumulative Supplements satisfy this requirement. The Addendum to this publication identifies drugs that qualify under the 1984 Amendments for periods of exclusivity (during which ANDAs or applications described in Section 505(b)(2) of the Act for those drugs may not be submitted for a specified period of time and, if allowed to be submitted, would be tentatively approved) and provides patent information concerning the listed drugs which also may delay the approval of ANDAs or Section 505(b)(2) applications. The Addendum also provides additional information that may be helpful to those submitting a new drug application to the Agency. The Agency intends to use this publication to further its objective of obtaining input and comment on the publication itself and related Agency procedures. Therefore, if you have comments on how the publication can be improved, please send them to the Director, Division of Labeling and Program Support, HFD-610, Office of Generic Drugs, Center for Drug and Evaluation and Research, 7620 Standish Place, Rockville, MD 20855. Comments received are publicly available to the extent allowable under the Freedom of Information regulations.

1. INTRODUCTION

1.1 Content and Exclusion The List is composed of four parts: (1) approved prescription drug products with therapeutic equivalence evaluations; (2) approved over-the-counter (OTC) drug products for those drugs that may not be marketed without NDAs or ANDAs because they are not covered under existing OTC monographs; (3) drug products with approval under Section 505 of the Act administered by the Center for Biologics Evaluation and Research; and (4) a cumulative list of approved products that have never been marketed, are for exportation, are for military use, have been discontinued from marketing, or have had their approvals withdrawn for other than safety or efficacy reasons subsequent to being discontinued from marketing. 1 This publication also includes indices of prescription and OTC drug products by trade or established name (if no trade name exists) and by applicant name (holder of the approved application). All established names for active ingredients generally conform to official compendial names or United States Adopted Names (USAN) as prescribed in (21 CFR 299.4(e)). The latter list includes applicants names as abbreviated in this publication; in addition, a list of uniform terms is provided. An Addendum contains drug patent and exclusivity information for the Prescription, OTC, Discontinued Drug Product Lists, and for the Drug Products with Approval under Section 505 of the Act Administered by the Center for Biologics Evaluation and Research. The publication may include additional information that the Agency deems appropriate to disseminate. Prior to the 6th Edition, the publication had excluded OTC drug products and drug products with approval under Section 505 of the Act administered by the Center for Biologics Evaluation and Research because the main purpose of the publication was to provide information to states regarding FDA's recommendation as to which generic prescription drug products were acceptable candidates for drug product selection. The 1984 Amendments required the Agency to begin publishing an up-to-date list of all marketed drug products, OTC as well as prescription, that have been approved for safety and efficacy and for which new drug applications are required. Under the 1984 Amendments, some drug products are given tentative approvals. The Agency will not include drug products with tentative approval in the List. Tentative approval lists are available at ANDA (Generic) Drug Approvals. When the tentative approval becomes a full approval through a subsequent action letter to the application holder, the Agency will list the drug product and the final approval date in the appropriate approved drug product list. Distributors or repackagers of products on the List are not identified. Because distributors or repackagers are not required to notify FDA when they shift their sources of supply from one approved manufacturer to another, it is not possible to maintain complete information linking product approval with the distributor or repackager handling the products. 1.2 Therapeutic Equivalence-Related Terms Pharmaceutical Equivalents. Drug products are considered pharmaceutical equivalents if they contain the same active ingredient(s), are of the same
1 Newly approved products are added to parts 1, 2, or 3, of the List, depending on the dispensing requirements (prescription or OTC) or approval authority, unless the Orange Book staff is otherwise notified before publication.

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dosage form, route of administration and are identical in strength or concentration (e.g., chlordiazepoxide hydrochloride, 5mg capsules). Pharmaceutically equivalent drug products are formulated to contain the same amount of active ingredient in the same dosage form and to meet the same or compendial or other applicable standards (i.e., strength, quality, purity, and identity), but they may differ in characteristics such as shape, scoring configuration, release mechanisms, packaging, excipients (including colors, flavors, preservatives), expiration time, and, within certain limits, labeling. Pharmaceutical Alternatives. Drug products are considered pharmaceutical alternatives if they contain the same therapeutic moiety, but are different salts, esters, or complexes of that moiety, or are different dosage forms or strengths (e.g., tetracycline hydrochloride, 250mg capsules vs. tetracycline phosphate complex, 250mg capsules; quinidine sulfate, 200mg tablets vs. quinidine sulfate, 200mg capsules). Data are generally not available for FDA to make the determination of tablet to capsule bioequivalence. Different dosage forms and strengths within a product line by a single manufacturer are thus pharmaceutical alternatives, as are extended-release products when compared with immediate-release or standard-release formulations of the same active ingredient. Therapeutic Equivalents. Drug products are considered to be therapeutic equivalents only if they are pharmaceutical equivalents and if they can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling. FDA classifies as therapeutically equivalent those products that meet the following general criteria: (1) they are approved as safe and effective; (2) they are pharmaceutical equivalents in that they (a) contain identical amounts of the same active drug ingredient in the same dosage form and route of administration, and (b) meet compendial or other applicable standards of strength, quality, purity, and identity; (3) they are bioequivalent in that (a) they do not present a known or potential bioequivalence problem, and they meet an acceptable in vitro standard, or (b) if they do present such a known or potential problem, they are shown to meet an appropriate bioequivalence standard; (4) they are adequately labeled; (5) they are manufactured in compliance with Current Good Manufacturing Practice regulations. The concept of therapeutic equivalence, as used to develop the List, applies only to drug products containing the same active ingredient(s) and does not encompass a comparison of different therapeutic agents used for the same condition (e.g., propoxyphene hydrochloride vs. pentazocine hydrochloride for the treatment of pain). Any drug product in the List repackaged and/or distributed by other than the application holder is considered to be therapeutically equivalent to the application holder's drug product even if the application holder's drug product is single source or coded as non-equivalent (e.g., BN). Also, distributors or repackagers of an application holder's drug product are considered to have the same code as the application holder. Therapeutic equivalence determinations are not made for unapproved, off-label indications. FDA considers drug products to be therapeutically equivalent if they meet the criteria outlined above, even though they may differ in certain other characteristics such as shape, scoring configuration, release mechanisms, packaging, excipients (including colors, flavors, preservatives), expiration date/time and minor aspects of labeling (e.g., the presence of specific pharmacokinetic information) and storage conditions. When such differences are important in the care of a particular patient, it may be appropriate for the prescribing physician to require that a particular brand be dispensed as a medical necessity. With this limitation, however, FDA believes that products classified as therapeutically equivalent can be substituted with the full expectation that the substituted product will produce the same clinical effect and safety profile as the prescribed product. Bioavailability. This term means the rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes

vii

available at the site of action. For drug products that are not intended to be absorbed into the bloodstream, bioavailability may be assessed by measurements intended to reflect the rate and extent to which the active ingredient or active moiety becomes available at the site of action. Bioequivalent Drug Products. This term describes pharmaceutical equivalent or pharmaceutical alternative products that display comparable bioavailability when studied under similar experimental conditions. Section 505 (j)(8)(B) of the Act describes one set of conditions under which a test and reference listed drug (see Section 1.4) shall be considered bioequivalent: the rate and extent of absorption of the test drug do not show a significant difference from the rate and extent of absorption of the reference drug when administered at the same molar dose of the therapeutic ingredient under similar experimental conditions in either a single dose or multiple doses; or the extent of absorption of the test drug does not show a significant difference from the extent of absorption of the reference drug when administered at the same molar dose of the therapeutic ingredient under similar experimental conditions in either a single dose or multiple doses and the difference from the reference drug in the rate of absorption of the drug is intentional, is reflected in its proposed labeling, is not essential to the attainment of effective body drug concentrations on chronic use, and is considered medically insignificant for the drug. Where these above methods are not applicable (e.g., for drug products that are not intended to be absorbed into the bloodstream), other in vivo or in vitro test methods to demonstrate bioequivalence may be appropriate. Bioequivalence may sometimes be demonstrated using an in vitro bioequivalence standard, especially when such an in vitro test has been correlated with human in vivo bioavailability data. In other situations, bioequivalence may sometimes be demonstrated through comparative clinical trials or pharmacodynamic studies. 1.3 Statistical Criteria for Bioequivalence Under the Drug Price Competition and Patent Term Restoration Act of 1984, manufacturers seeking approval to market a generic drug product must submit data demonstrating that the drug product is bioequivalent to the pioneer (innovator) drug product. A major premise underlying the 1984 law is that bioequivalent drug products are therapeutically equivalent, and therefore, interchangeable. Bioavailability refers to the rate and extent to which the active ingredient or therapeutic ingredient is absorbed from a drug product and becomes available at the site of drug action (Federal Food, Drug and Cosmetic Act, section 505(j)(8)). Bioequivalence refers to equivalent release of the same drug substance from two or more drug products or formulations. This leads to an equivalent rate and extent of absorption from these formulations. Underlying the concept of bioequivalence is the thesis that, if a drug product contains a drug substance that is chemically identical and is delivered to the site of action at the same rate and extent as another drug product, then it is equivalent and can be substituted for that drug product. Methods used to define bioequivalence can be found in 21 CFR 320.24, and include (1) pharmacokinetic (PK) studies, (2) pharmacodynamic (PD) studies, (3) comparative clinical trials, and (4) in-vitro studies. The choice of study used is based on the site of action of the drug and the ability of the study design to compare drug delivered to that site by the two products. The standard bioequivalence (PK) study is conducted using a two-treatment crossover study design in a limited number of volunteers, usually 24 to 36

viii

adults. Alternately, a four-period, replicate design crossover study may also be used. Single doses of the test and reference drug products are administered and blood or plasma levels of the drug are measured over time. Pharmacokinetic parameters characterizing rate and extent of drug absorption are evaluated statistically. The PK parameters of interest are the resulting area under the plasma concentration-time curve (AUC), calculated to the last measured concentration (AUC(0-t)) and extrapolated to infinity (AUC(0-inf)), for extent of absorption; and the maximum or peak drug concentrations (Cmax), for rate of absorption. Crossover studies may not be practical in drugs with a long half-life in the body, and a parallel study design may be used instead. Alternate study methods, such as in-vitro studies or equivalence studies with clinical or pharmacodynamic endpoints, are used for drug products where plasma concentrations are not useful to determine delivery of the drug substance to the site of activity (such as inhalers, nasal sprays and topical products applied to the skin). The statistical methodology for analyzing these bioequivalence studies is called the two one-sided test procedure. Two situations are tested with this statistical methodology. The first of the two one-sided tests determines whether a generic product (test), when substituted for a brand-name product (reference) is significantly less bioavailable. The second of the two onesided tests determines whether a brand-name product when substituted for a generic product is significantly less bioavailable. Based on the opinions of FDA medical experts, a difference of greater than 20% for each of the above tests was determined to be significant, and therefore, undesirable for all drug products. Numerically, this is expressed as a limit of test-product average/reference-product average of 80% for the first statistical test and a limit of reference-product average/test-product average of 80% for the second statistical test. By convention, all data is expressed as a ratio of the average response (AUC and Cmax) for test/reference, so the limit expressed in the second statistical test is 125% (reciprocal of 80%). For statistical reasons, all data is log-transformed prior to conducting statistical testing. In practice, these statistical tests are carried out using an analysis of variance procedure (ANOVA) and calculating a 90% confidence interval for each pharmacokinetic parameter (Cmax and AUC). The confidence interval for both pharmacokinetic parameters, AUC and Cmax, must be entirely within the 80% to 125% boundaries cited above. Because the mean of the study data lies in the center of the 90% confidence interval, the mean of the data is usually close to 100% (a test/reference ratio of 1). Different statistical criteria are sometimes used when bioequivalence is demonstrated through comparative clinical trials pharmacodynamic studies, or comparative in-vitro methodology. The bioequivalence methodology and criteria described above simultaneously control for both differences in the average response between test and reference, as well as the precision with which the average response in the population is estimated. This precision depends on the within-subject (normal volunteer or patient) variability in the pharmacokinetic parameters (AUC and Cmax) of the two products and on the number of subjects in the study. The width of the 90% confidence interval is a reflection in part of the withinsubject variability of the test and reference products in the bioequivalence study. A test product with no differences in the average response when compared to the reference might still fail to pass the bioequivalence criteria if the variability of one or both products is high and the bioequivalence study has insufficient statistical power (i.e., insufficient number of subjects). Likewise, a test product with low variability may pass the bioequivalence criteria, when there are somewhat larger differences in the average response. This system of assessing bioequivalence of generic products assures that these substitutable products do not deviate substantially in in-vivo performance from the reference product. The Office of Generic Drugs has conducted two surveys to quantify the differences between generic and brand name products. The first survey included 224 bioequivalence studies submitted

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in approved applications during 1985 and 1986. The observed average differences between reference and generic products for AUC was 3.5% (JAMA, Sept. 4, 1987, Vol. 258, No. 9). The second survey included 127 bioequivalence studies submitted to the agency in 273 ANDAs approved in 1997. The three measures reviewed include AUC(0-t), AUC(0-inf), and Cmax. The observed average differences between the reference and generic products were + 3.47% (SD 2.84) for AUC(0-t), + 3.25% (SD 2.97) for AUC(0-inf), and + 4.29% (SD 3.72) for Cmax (JAMA, Dec. 1, 1999, Vol. 282, No. 21). The primary concern from the regulatory point of view is the protection of the patient against approval of products that are not bioequivalent. The current practice of carrying out two one-sided tests at the 0.05 level of significance ensures that there is no more than a 5% chance that a generic product that is not truly equivalent to the reference will be approved. 1.4 Reference Listed Drug A reference listed drug (21 CFR 314.94(a)(3)) means the listed drug identified by FDA as the drug product upon which an applicant relies in seeking approval of its ANDA. FDA has identified in the Prescription Drug Product and OTC Drug Product Lists those reference listed drugs to which the in vivo bioequivalence (reference standard) and, in some instances, the in vitro bioequivalence of the applicant's product is compared. By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. Such variations could result if generic drugs were compared to different reference listed drugs. However, in some instances when listed drugs are approved for a single drug product, a product not designated as the reference listed drug and not shown to be bioequivalent to the reference listed drug may be shielded from generic competition. A firm wishing to market a generic version of a listed drug that is not designated as the reference listed drug may petition the Agency through the Citizen Petition procedure (see 21 CFR 10.25(a) and CFR 10.30). When the Citizen Petition is approved, the second listed drug will be designated as an additional reference listed drug and the petitioner may submit an Abbreviated New Drug Application citing the designated reference listed drug. Section 1.7, Therapeutic Equivalence Evaluations Codes products meeting necessary bioequivalence requirements explains the (AB, AB1, AB2, AB3... coding system for multisource drug products listed under the same heading with two reference listed drugs. In addition, there are two situations in which two listed drugs that have been shown to be bioequivalent to each other may both be designated as reference listed drugs. The first situation occurs when the in vivo determination of bioequivalence is self-evident and a waiver of the in vivo bioequivalence may be granted. The second situation occurs when the bioequivalence of two listed products may be determined through in vitro methodology. The reference listed drug is identified by the symbol "+" in the Prescription and Over-the-Counter (OTC) Drug Product Lists. These identified reference listed drugs represent the best judgment of the Division of Bioequivalence at this time. The Prescription and OTC Drug Product Lists identify reference drugs for oral dosage forms, Injectables, ophthalmics, otics, and topical products. It is recommended that a firm planning to conduct an in vivo bioequivalence study, or planning to manufacture a batch of a drug product for which an in vivo waiver of bioequivalence will be requested, contact the Division of Bioequivalence, Office of Generic Drugs, to confirm the appropriate reference listed drug.

1.5 General Policies and Legal Status The List contains public information and advice. It does not mandate the drug products which is purchased, prescribed, dispensed, or substituted for one another, nor does it, conversely, mandate the products that should be avoided. To the extent that the List sets forth FDA's evaluations of the therapeutic equivalence of drug products that have been approved, it contains FDA's advice to the public, to practitioners and to the states regarding drug product selection. These evaluations do not constitute determinations that any product is in violation of the Act or that any product is preferable to any other. Therapeutic equivalence evaluations are a scientific judgment based upon evidence, while generic substitution may involve social and economic policy administered by the states, intended to reduce the cost of drugs to consumers. To the extent that the List identifies drug products approved under Section 505 of the Act, it sets forth information that the Agency is required to publish and that the public is entitled to under the Freedom of Information Act. Exclusion of a drug product from the List does not necessarily mean that the drug product is either in violation of Section 505 of the Act, or that such a product is not safe or effective, or that such a product is not therapeutically equivalent to other drug products. Rather, the exclusion is based on the fact that FDA has not evaluated the safety, effectiveness, and quality of the drug product. 1.6 Practitioner/User Responsibilities

Professional care and judgment should be exercised in using the List. Evaluations of therapeutic equivalence for prescription drugs are based on scientific and medical evaluations by FDA. Products evaluated as therapeutically equivalent can be expected, in the judgment of FDA, to have equivalent clinical effect and no difference in their potential for adverse effects when used under the conditions of their labeling. However, these products may differ in other characteristics such as shape, scoring configuration, release mechanisms, packaging, excipients (including colors, flavors, preservatives), expiration date/time, and, in some instances, labeling. If products with such differences are substituted for each other, there is a potential for patient confusion due to differences in color or shape of tablets, inability to provide a given dose using a partial tablet if the proper scoring configuration is not available, or decreased patient acceptance of certain products because of flavor. There may also be better stability of one product over another under adverse storage conditions, or allergic reactions in rare cases due to a coloring or a preservative ingredient, as well as differences in cost to the patient. FDA evaluation of therapeutic equivalence in no way relieves practitioners of their professional responsibilities in prescribing and dispensing such products with due care and with appropriate information to individual patients. In those circumstances where the characteristics of a specific product, other than its active ingredient, are important in the therapy of a particular patient, the physician's specification of that product is appropriate. Pharmacists must also be familiar with the expiration dates/times and labeling directions for storage of the different products, particularly for reconstituted products, to assure that patients are properly advised when one product is substituted for another. Multisource and single-source drug products. FDA has evaluated for therapeutic equivalence only multisource prescription drug products approved under Section 505 of the Act, which in most instances means those pharmaceutical equivalents available from more than one manufacturer. For such products, a therapeutic equivalence code is included and, in addition, product information is highlighted in bold face and underlined. Those products with approved applications that are single-source (i.e., there is only one approved product available for that active ingredient, dosage form, route of administration, and strength) are also included on the List, but no therapeutic equivalence code is included with such products. Any drug product

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in the List repackaged and/or distributed by other than the application holder is considered to be therapeutically equivalent to the application holder's drug product even if the application holder's drug product is single source or coded as non-equivalent (e.g., BN). Also, although not identified in the List, distributors or repackagers of an application holder's drug product are considered to have the same code as the application holder. The details of these codes and the policies underlying them are discussed in Section 1.7, Therapeutic Equivalence Evaluations Codes. Products on the List are identified by the names of the holders of approved applications (applicants) who may not necessarily be the manufacturer of the product. The applicant may have had its product manufactured by a contract manufacturer and may simply be distributing the product for which it has obtained approval. In most instances, however, the manufacturer of the product is also the applicant. The name of the manufacturer is permitted by regulation to appear on the label, even when the manufacturer is not the marketer. Although the products on the List are identified by the names of the applicants, circumstances, such as changing corporate ownership, have sometimes made identification of the applicant difficult. The Agency believes, based on continuing document review and communication with firms, that the applicant designations on the List are, in most cases, correct. To relate firm name information on a product label to that on the List, the following should be noted: the applicant's name always appears on the List. This applies whether the applicant (firm name on the Form FDA 356h in the application) is the marketer (firm name in largest letters on the label) or not. However, the applicant's name may not always appear on the label of the product. If the applicant is the marketer, its name appears on the List and on the label; if the applicant is not the marketer, and the Agency is aware of a corporate relationship (e.g., parent and subsidiary) between the applicant and the marketer, the name of the applicant appears on the List and both firm names may appear on the label. Firms with known corporate relationships are displayed in Appendix B. If there is no known corporate relationship between the applicant and the marketer, the applicant's name appears on the List; however, unless the applicant is the manufacturer, packager, or distributor, the applicant's name may not appear on the label. In this case, the practitioner, from labeling alone, will not be able to relate the marketed product to an applicant cited in the List, and hence to a specific approved drug product. In such cases, to assure that the product in question is the subject of an approved application, the firm named on the label should be contacted. To relate trade name (proprietary name) information on a product label to that on the List, the following should be noted: if the applicant is the marketer, its name appears on the List and on the label; if the Agency is aware of a corporate relationship between the applicant and the marketer, the trade name (proprietary name) of the drug product (established drug name if no trade name exists) appears on the List. If a corporate relationship exists between an application holder and a marketer and both firms are distributing the drug product, the FDA reserves the right to select the trade name of either the marketer or the application holder to appear on the List. If there is no known corporate relationship between the applicant and the marketer, the established drug name appears on the List. Every product on the List is subject at all times to regulatory action. From time to time, approved products may be found in violation of one or more provisions of the Act. In such circumstances, the Agency will commence appropriate enforcement action to correct the violation, if necessary, by securing removal of the product from the market by voluntary recall, seizure, or other enforcement actions. Such regulatory actions are, however, independent of the inclusion of a product on the List. The main criterion for

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inclusion of a product is that it has an application with an effective approval that has not been withdrawn for safety or efficacy reasons. FDA believes that retention of a violative product on the List will not have any significant adverse health consequences, because other legal mechanisms are available to the Agency to prevent the product's actual marketing. FDA may however, change a product's therapeutic equivalence rating if the circumstances giving rise to the violation change or otherwise call into question the data upon which the Agency's assessment of whether a product meets the criteria for therapeutic equivalence was made.

1.7 Therapeutic Equivalence Evaluations Codes The coding system for therapeutic equivalence evaluations is constructed to allow users to determine quickly whether the Agency has evaluated a particular approved product as therapeutically equivalent to other pharmaceutically equivalent products (first letter) and to provide additional information on the basis of FDA's evaluations (second letter). With few exceptions, the therapeutic equivalence evaluation date is the same as the approval date. The two basic categories into which multisource drugs have been placed are indicated by the first letter as follows: A Drug products that FDA considers to be therapeutically equivalent to other pharmaceutically equivalent products, i.e., drug products for which: (1) there are no known or suspected bioequivalence problems. These are designated AA, AN, AO, AP, or AT, depending on the dosage form; or (2) actual or potential bioequivalence problems have been resolved with adequate in vivo and/or in vitro evidence supporting bioequivalence. These are designated AB. B Drug products that FDA at this time, considers not to be therapeutically equivalent to other pharmaceutically equivalent products, i.e., drug products for which actual or potential bioequivalence problems have not been resolved by adequate evidence of bioequivalence. Often the problem is with specific dosage forms rather than with the active ingredients. These are designated BC, BD, BE, BN, BP, BR, BS, BT, BX, or B*. Individual drug products have been evaluated as therapeutically equivalent to the reference product in accordance with the definitions and policies outlined below: "A" CODES Drug products that are considered to be therapeutically equivalent to other pharmaceutically equivalent products. "A" products are those for which actual or potential bioequivalence problems have been resolved with adequate in vivo and/or in vitro evidence supporting bio-equivalence. Drug products designated with an "A" code fall under one of two main policies: (1) for those active ingredients or dosage forms for which no in vivo bioequivalence issue is known or suspected, the information necessary to show bioequivalence between pharmaceutically equivalent products is presumed and considered self-evident based on other data in the application for some dosage forms (e.g., solutions) or satisfied for

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solid oral dosage forms by a showing that an acceptable in vitro dissolution standard is met. A therapeutically equivalent rating is assigned such products so long as they are manufactured in accordance with Current Good Manufacturing Practice regulations and meet the other requirements of their approved applications (these are designated AA, AN, AO, AP, or AT, depending on the dosage form, as described below); or (2) for those DESI drug products containing active ingredients or dosage

forms that have been identified by FDA as having actual or potential

bioequivalence problems, and for post-1962 drug products in a dosage

form presenting a potential bioequivalence problem, an evaluation of

therapeutic equivalence is assigned to pharmaceutical equivalents only

if the approved application contains adequate scientific evidence

establishing through in vivo and/or in vitro studies the bioequivalence

of the product to a selected reference product (these products are

designated as AB).
There are some general principles that may affect the substitution of pharmaceutically equivalent products in specific cases. Prescribers and dispensers of drugs should be alert to these principles so as to deal appropriately with situations that require professional judgment and discretion. There may be labeling differences among pharmaceutically equivalent products that require attention on the part of the health professional. For example, pharmaceutically equivalent powders to be reconstituted for administration as oral or injectable liquids may vary with respect to their expiration time or storage conditions after reconstitution. An FDA evaluation that such products are therapeutically equivalent is applicable only when each product is reconstituted, stored, and used under the conditions specified in the labeling of that product. The Agency will use notes in this publication to point out special situations such as potential differences between two drug products that have been evaluated as bioequivalent and otherwise therapeutically equivalent, when they should be brought to the attention of health professionals. These notes are contained in Section 1.8, Description of Special Situations. For example, in rare instances, there may be variations among therapeutically equivalent products in their use or in conditions of administration. Such differences may be due to patent or exclusivity rights associated with such use. When such variations may, in the Agency's opinion, affect prescribing or substitution decisions by health professionals, a note will be added to Section 1.8. Also, occasionally a situation may arise in which changes in a listed drug product after its approval (for example, a change in dosing interval) may have an impact on the substitutability of already approved generic versions of that product that were rated by the Agency as therapeutically equivalent to the listed product. When such changes in the listed drug product are considered by the Agency to have a significant impact on therapeutic equivalence, the Agency will change the therapeutic equivalence ratings for other versions of the drug product unless the manufacturers of those other versions of the product provide additional information to assure equivalence under the changed conditions. Pending receipt of the additional data, the Agency may add a note to Section 1.8, or, in rare cases, may even change the therapeutic equivalence rating. In some cases (e.g., Isolyte S w/ Dextrose 5% in Plastic Container and Plasma-Lyte 148 and Dextrose 5% in Plastic Container), closely related products are listed as containing the same active ingredients, but in somewhat different amounts. In determining which of these products are pharmaceutically equivalent, the Agency has considered products to be pharmaceutically equivalent with labeled strengths of an ingredient that do not vary by more than 1%.

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Different salts and esters of the same therapeutic moiety are regarded as pharmaceutical alternatives. For the purpose of this publication, such products are not considered to be therapeutically equivalent. There are no instances in this List where pharmaceutical alternatives are evaluated or coded with regard to therapeutic equivalence. Anhydrous and hydrated entities, as well as different polymorphs, are considered pharmaceutical equivalents and must meet the same standards and, where necessary, as in the case of ampicillin/ampicillin trihydrate, their equivalence is supported by appropriate bioavailability/bioequivalence studies. The codes in this book are not intended to preclude health care professionals from converting pharmaceutically different concentrations into pharmaceutical equivalents using accepted professional practice. Where package size variations have therapeutic implications, products so packaged have not been considered pharmaceutically equivalent. For example, some oral contraceptives are supplied in 21-tablet and 28-tablet packets; the 28-tablet packets contain 7 placebo or iron tablets. These two packaging configurations are not regarded as pharmaceutically equivalent; thus, they are not designated as therapeutically equivalent. Preservatives may differ among some therapeutically equivalent drug products. Differences in preservatives and other inactive ingredients do not affect FDA's evaluation of therapeutic equivalence except in cases where these components may influence bioequivalence or routes of administration. The specific sub-codes for those drugs evaluated as therapeutically equivalent and the policies underlying these sub-codes follow: AA Products in conventional dosage forms not presenting bioequivalence problems Products coded as AA contain active ingredients and dosage forms that are not regarded as presenting either actual or potential bioequivalence problems or drug quality or standards issues. However, all oral dosage forms must, nonetheless, meet an appropriate in vitro bioequivalence standard that is acceptable to the Agency in order to be approved. AB, AB1, AB2, AB3... Products meeting necessary bioequivalence requirements Multisource drug products listed under the same heading (i.e., identical active ingredients(s), dosage form, and route(s) of administration) and having the same strength (see Section 1.2, Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (i.e., AB1, AB2, AB3, etc.). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against. For example, Adalat CC (Miles) and Procardia XL (Pfizer), extendedrelease tablets, are listed under the active ingredient nifedipine. These drug products, listed under the same heading, are not bioequivalent to each other. Generic drug products deemed by FDA to be bioequivalent to Adalat CC and Procardia XL have been approved, Adalat CC and Procardia XL have been assigned ratings of AB1 and AB2, respectively. The generic drug products bioequivalent to Adalat CC would be assigned a rating of AB1 and those bioequivalent to Procardia XL would be assigned a rating of

xv

AB2. (The assignment of an AB1 or AB2 rating to a specific product does not imply product preference.) Even though drug products of distributors and/or repackagers are not included in the List, they are considered therapeutically equivalent to the application holder's drug product if the application holder's drug product is rated either with an AB or threecharacter code or is single source in the List. Drugs coded as AB under a heading are considered therapeutically equivalent only to other drugs coded as AB under that heading. Drugs coded with a three-character code under a heading are considered therapeutically equivalent only to other drugs coded with the same three-character code under that heading. AN Solutions and powders for aerosolization Uncertainty regarding the therapeutic equivalence of aerosolized products arises primarily because of differences in the drug delivery system. Solutions and powders intended for aerosolization that are marketed for use in any of several delivery systems are considered to be pharmaceutically and therapeutically equivalent and are coded AN. Those products that are compatible only with a specific delivery system or those products that are packaged in and with a specific delivery system are coded BN, unless they have met an appropriate bioequivalence standard. Solutions or suspensions in a specific delivery system will be coded AN if the bioequivalence standard is based upon in vitro methodology, if bioequivalence needs to be demonstrated by in vivo methodology then the drug products will be coded AB.

AO Injectable oil solutions The absorption of drugs in injectable (parenteral) oil solutions may vary substantially with the type of oil employed as a vehicle and the concentration of the active ingredient. Injectable oil solutions are therefore considered to be pharmaceutically and therapeutically equivalent only when the active ingredient, its concentration, and the type of oil used as a vehicle are all identical.

AP Injectable aqueous solutions and, in certain instances, intravenous non-aqueous solutions It should be noted that even though injectable (parenteral) products under a specific listing may be evaluated as therapeutically equivalent, there may be important differences among the products in the general category, Injectable; Injection. For example, some injectable products that are rated therapeutically equivalent are labeled for different routes of administration. In addition, some products evaluated as therapeutically equivalent may have different preservatives or no preservatives at all. Injectable products available as dry powders for reconstitution, concentrated sterile solutions for dilution, or sterile solutions ready for injection are pharmaceutical alternative drug products. They are not rated as therapeutically equivalent (AP) to each other even if these pharmaceutical alternative drug products are designed to produce the same concentration prior to injection and are similarly labeled. Consistent with accepted professional practice, it is the responsibility of the prescriber, dispenser, or individual administering the product to be familiar with a product's labeling to assure that it is given only by the route(s) of administration stated in the labeling. Certain commonly used large volume intravenous products containers are not included on the List (e.g., dextrose dextrose injection 10%, sodium chloride injection 0.9%) products are on the market without FDA approval and the in glass injection 5%, since these FDA has not

xvi

published conditions for marketing such parenteral products under approved NDAs. When packaged in plastic containers, however, FDA regulations require approved applications prior to marketing. Approval then depends on, among other things, the extent of the available safety data involving the specific plastic component of the product. All large volume parenteral products are manufactured under similar standards, regardless of whether they are packaged in glass or plastic. Thus, FDA has no reason to believe that the packaging container of large volume parenteral drug products that are pharmaceutically equivalent would have any effect on their therapeutic equivalence. The strength of parenteral drugs products is defined as the total drug content of the container. Until recently the strength of liquid parenteral drug products in the Orange Book have not been displayed. The concentration of the liquid parenteral drug product in the Orange Book has been shown as xmg/ml. The amount of dry powder or freeze dried powder in a container has always been identified as the strength. With the finalization of the Waxman-Hatch amendments that characterized each strength of a drug product as a listed drug, it became evident that the format of the Orange Book should be changed to reflect each strength of a parenteral solution. To this end the OGD has started to display the strength of all new approvals of parenteral solutions. Previously we would have displayed only the concentration of an approved parenteral solution, e.g. 50mg/ml. If this drug product had a 20 ml and 60 ml container approved the two products would be shown as 1Gm / 20ml (50mg/ml) and 3Gm / 60ml (50mg/ml).

AT Topical products There are a variety of topical dosage forms available for dermatologic, ophthalmic, otic, rectal, and vaginal administration, including creams, gels, lotions, oils, ointments, pastes, solutions, sprays and suppositories. Even though different topical dosage forms may contain the same active ingredient and potency, these dosage forms are not considered pharmaceutically equivalent. Therefore, they are not considered therapeutically equivalent. All solutions and DESI drug products containing the same active ingredient in the same topical dosage form for which a waiver of in vivo bioequivalence has been granted and for which chemistry and manufacturing processes are adequate to demonstrate bioequivalence, are considered therapeutically equivalent and coded AT. Pharmaceutically equivalent topical products that raise questions of bioequivalence, including all post-1962 non-solution topical drug products, are coded AB when supported by adequate bioequivalence data, and BT in the absence of such data.

"B" CODES Drug products that FDA, at this time, considers not to be therapeutically equivalent to other pharmaceutically equivalent products. "B" products, for which actual or potential bioequivalence problems have not been resolved by adequate evidence of bioequivalence, often have a problem with specific dosage forms rather than with the active ingredients. Drug products designated with a "B" code fall under one of three main policies: (1) the drug products contain active ingredients or are manufactured in dosage forms that have been identified by the Agency as having documented bio-equivalence problems or a significant potential for such problems and for which no adequate studies demonstrating bioequivalence have been submitted to FDA; or

xvii

(2) (3)

the quality standards are inadequate or FDA has an insufficient basis to determine therapeutic equivalence; or the drug products are under regulatory review.

The specific coding definitions and policies for the "B" sub-codes are as follows:

B* Drug products requiring further FDA investigation and review to determine therapeutic equivalence The code B* is assigned to products previously assigned an A or B code when FDA receives new information that raises a significant question regarding therapeutic equivalence that can be resolved only through further Agency investigation and/or review of data and information submitted by the applicant. The B* code signifies that the Agency will take no position regarding the therapeutic equivalence of the product until the Agency completes its investigation and review. BC Extended-release dosage forms (capsules, injectables and tablets) Extended-release tablets are formulated in such a manner as to make the contained medicament available over an extended period of time following ingestion. Although bioavailability studies have been conducted on these dosage forms, they may be subject to bioavailability differences, primarily because firms developing extended-release products for the same active ingredient rarely employ the same formulation approach. FDA, therefore, does not consider different extended-release dosage forms containing the same active ingredient in equal strength to be therapeutically equivalent unless equivalence between individual products in both rate and extent has been specifically demonstrated through appropriate bioequivalence studies. Extended-release products for which such bioequivalence data have not been submitted are coded BC, while those for which such data are available have been coded AB.

BD Active ingredients and dosage forms with documented bioequivalence problems The BD code denotes products containing active ingredients with known bioequivalence problems and for which adequate studies have not been submitted to FDA demonstrating bioequivalence. Where studies showing bioequivalence have been submitted, the product has been coded AB.

BE Delayed-release oral dosage forms Where the drug may be destroyed or inactivated by the gastric juice or where it may irritate the gastric mucosa, the use of enteric coatings is indicated. Such coatings are intended to delay the release of the medication until the tablet has passed through the stomach. Drug products in delayed-release dosage forms containing the same active ingredients are subject to significant differences in absorption. Unless otherwise specifically noted, the Agency considers different delayed-release products containing the same active ingredients as presenting a potential bioequivalence problem and codes these products BE in the absence of in vivo studies showing bioequivalence. If adequate in vivo studies have demonstrated the bioequivalence of specific delayed-release products, such products are coded AB.

xviii

BN Products in aerosol-nebulizer drug delivery systems This code applies to drug solutions or powders that are marketed only as a component of, or as compatible with, a specific drug delivery system. There may, for example, be significant differences in the dose of drug and particle size delivered by different products of this type. Therefore, the Agency does not consider different metered aerosol dosage forms containing the same active ingredient(s) in equal strengths to be therapeutically equivalent unless the drug products meet an appropriate bioequivalence standard, such products are coded AB.

BP Active ingredients and dosage forms with potential bioequivalence problems FDA's bioequivalence regulations (21 CFR 320.33) contain criteria and procedures for determining whether a specific active ingredient in a specific dosage form has a potential for causing a bioequivalence problem. It is FDA's policy to consider an ingredient meeting these criteria as having a potential bioequivalence problem even in the absence of positive data demonstrating inequivalence. Pharmaceutically equivalent products containing these ingredients in oral dosage forms are coded BP until adequate in vivo bioequivalence data are submitted, such products are coded AB. Injectable suspensions containing an active ingredient suspended in an aqueous or oleaginous vehicle have also been coded BP. Injectable suspensions are subject to bioequivalence problems because differences in particle size, polymorphic structure of the suspended active ingredient, or the suspension formulation can significantly affect the rate of release and absorption. FDA does not consider pharmaceutical equivalents of these products bioequivalent without adequate evidence of bioequivalence, such products would be coded AB.

BR Suppositories or enemas that deliver drugs for systemic absorption The absorption of active ingredients from suppositories or enemas that are intended to have a systemic effect (as distinct from suppositories administered for local effect) can vary significantly from product to product. Therefore, FDA considers pharmaceutically equivalent systemic suppositories or enemas bio-equivalent only if in vivo evidence of bioequivalence is available. In those cases where in vivo evidence is available, the product is coded AB. If such evidence is not available, the products are coded BR.

BS Products having drug standard deficiencies If the drug standards for an active ingredient in a particular dosage form are found by FDA to be deficient so as to prevent an FDA evaluation of either pharmaceutical or therapeutic equivalence, all drug products containing that active ingredient in that dosage form are coded BS. For example, if the standards permit a wide variation in pharmacologically active components of the active ingredient such that pharmaceutical equivalence is in question, all products containing that active ingredient in that dosage form are coded BS.

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BT Topical products with bioequivalence issues This code applies mainly to post-1962 dermatologic, ophthalmic, otic, rectal, and vaginal products for topical administration, including creams, ointments, gels, lotions, pastes, and sprays, as well as suppositories not intended for systemic drug absorption. Topical products evaluated as having acceptable clinical performance, but that are not bioequivalent to other pharmaceutically equivalent products or that lack sufficient evidence of bioequivalence, will be coded BT.

BX Drug products for which the data are insufficient to determine therapeutic equivalence The code BX is assigned to specific drug products for which the data that have been reviewed by the Agency are insufficient to determine therapeutic equivalence under the policies stated in this document. In these situations, the drug products are presumed to be therapeutically inequivalent until the Agency has determined that there is adequate information to make a full evaluation of therapeutic equivalence.

1.8 Description of Special Situations Certain drugs listed in the Orange Book present special situations that merit further discussion. Following is a description of those special situations: Amino Acid and Protein Hydrolysate Injections. These products differ in the amount and kinds of amino acids they contain and, therefore, are not considered pharmaceutical equivalents. For this reason, these products are not considered therapeutically equivalent. At the same time, the Agency believes that it is appropriate to point out that where nitrogen balance is the sole therapeutic objective and individual amino acid content is not a consideration, pharmaceutical alternatives with the same total amount of nitrogen content may be considered therapeutically equivalent. Follitropin Alfa and Beta. Based on available data derived from physico chemical tests and bioassay, follitropin alfa and follitropin beta are indistinguishable. Gaviscon. Gaviscon is an OTC product which has been marketed since September 1970. The active ingredients in this product, aluminum hydroxide and magnesium trisilicate, were reviewed by the Agency's OTC Antacid Panel and were considered to be safe and effective ingredients (Category I) by that Panel. However, the tablet failed to pass the antacid test which is required of all antacid products. The Agency, therefore, placed the tablet in Category III for lack of effectiveness. A full NDA with clinical studies was submitted by Marion Laboratories, Inc., and approved by FDA on December 9, 1983. Gaviscons activity in treating reflux acidity is made possible by the physical-chemical properties of the inactive ingredients, sodium bicarbonate and alginic acid. Therefore, all ANDAs which cite Gaviscon tablets as the listed drug must contain the inactive ingredients sodium bicarbonate and alginic acid. A full NDA will be required to support the effectiveness of the drug product if different inactive ingredients are to be substituted for sodium bicarbonate or alginic acid or if different proportions of these ingredients are to be used. Levothyroxine Sodium. Because there are multiple reference listed drugs of levothyroxine sodium tablets and some reference listed drugs' sponsors have conducted studies to establish their drugs' therapeutic equivalence to other reference listed drugs, FDA has determined that its usual practice of assigning two or three character TE codes may be potentially confusing and inadequate for these drug products. Accordingly, FDA provides the following explanation and chart of therapeutic equivalence evaluations for levothyroxine

xx

sodium drug products. Levothyroxine Sodium (Mylan ANDA 76187) tablets have been determined to be therapeutically equivalent to corresponding strengths of Unithroid (Jerome Stevens NDA 021210) tablets. Levo-T (Alara NDA 021342), Levothyroxine Sodium (Mylan ANDA 76187), Unithroid (Jerome Stevens NDA 021210), and Levothyroxine Sodium (Merck KGAA ANDA 76752)tablets have been determined to be therapeutically equivalent to corresponding strengths of Synthroid (Abbott NDA 021402) tablets. Levo-T (Alara NDA 021342), Unithroid (Jerome Stevens NDA 021210), Levothyroxine Sodium (Mylan ANDA 076187), and Levothyroxine Sodium (Merck KGAA ANDA 76752) tablets have been determined to be therapeutically equivalent to corresponding strengths of Levoxyl (King Pharms NDA 021301) tablets. Levothyroxine Sodium (Mylan ANDA 76187) tablets have been determined to be therapeutically equivalent to corresponding strengths of Levothroid (Lloyd NDA 021116) tablets. The chart outlines TE codes for all 0.025mg products. Other product strengths may be similar. Therapeutic equivalence has been established between products that have the same AB+number TE code. More than one TE code may apply to some products. One common TE code indicates therapeutic equivalence between products. Trade Name
UNITHROID LEVOTHYROXINE SODIUM LEVOXYL SYNTHROID LEVO-T

Applicant
STEVENS J MYLAN KING PHARMS ABBOTT ALARA PHARM

Potency
0.025MG 0.025MG 0.025MG 0.025MG 0.025MG

TE Code
AB1 AB1 AB1 AB1 AB1

Appl No
021210 076187 021301 021402 021342

Product No
001 001 001 001 001

SYNTHROID LEVOTHYROXINE SODIUM LEVO-T UNITHROID LEVOTHYROXINE SODIUM

ABBOTT MYLAN ALARA PHARM STEVENS J MERCK KGAA

0.025MG 0.025MG 0.025MG 0.025MG 0.025MG

AB2 AB2 AB2 AB2 AB2

021402 076187 021342 021210 076752

001 001 001 001 001

LEVOXYL LEVO-T UNITHROID LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM

KING PHARMS ALARA PHARM STEVENS J MYLAN MERCK KGAA

0.025MG 0.025MG 0.025MG 0.025MG 0.025MG

AB3 AB3 AB3 AB3 AB3

021301 021342 021210 076187 076752

001 001 001 001 001

LEVOTHROID LEVOTHYROXINE SODIUM

LLOYD MYLAN

0.025MG 0.025MG

AB4 AB4

021116 076187

001 001

Patent Certification(s) Reference Listed Drug based upon a suitability petition. An abbreviated new drug application that refers to a Reference Listed Drug (RLD) approved pursuant to a suitability petition must demonstrate that the proposed product is bioequivalent to the RLD, and it must include appropriate patent certification(s) and an exclusivity statement with respect to the listed drug which served as the basis for the approved suitability petition. This concept also applies to an ANDA applicant that cites a RLD that was based upon an NDA that is still covered by patent (s) and/or

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exclusivity, e.g. a second RLD that was selected when the in vivo determination of bioequivalence of the original RLD is self evident and the waiver of the in vivo determination of bioequivalence may be granted. Waived exclusivity. If a new drug application (NDA) submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (Act) qualifies for exclusivity under sections 505(c)(3)(D) and 505(j)(5)(D), the exclusivity is listed in the Patent and Exclusivity Section of the Orange Book. If a drug product has received this exclusivity, the FDA will delay the approval of a 505(b)(2) application or an abbreviated new drug application (ANDA) under section 505(j) of the Act until the expiration of the exclusivity. If the listed drug is also protected by one or more patents, the approval date for the 505(b)(2) application or ANDA will be determined by the latest expiring patent or exclusivity listed in the Orange Book. However, the holder of the NDA may waiver its exclusivity as to any or all 505(b)(2) and ANDA applications referencing the protected drug product. If an NDA sponsor waivers its right to the exclusivity protection, qualified 505(b)(2) or ANDA applications may be approved without regard to the NDA holder's exclusivity. An NDA for which the holder has waived its exclusivity as to all 505(b)(2) and ANDA applications will be coded with a W in the Patent and Exclusivity Section of the Orange Book and be referred to this section. The applicant referencing this listed drug should indicate in the exclusivity statement that the holder of the listed drug has waived its exclusivity.

1.9 Therapeutic Equivalence Code Change for a Drug Entity The Agency will use the following procedures when, in response to a petition or on its own initiative, it is considering a change in the therapeutic equivalence code for approved multi-source drug products. Such changes will generally occur when the Agency becomes aware of new scientific information affecting the therapeutic equivalence of an entire category of drug products in the List (e.g., information concerning the active ingredient or the dosage form), rather than information concerning a single drug product within the category. These procedures will be used when a change in therapeutic equivalence code is under consideration for all drug products found in the Prescription Drug Product List under a specific drug entity and dosage form. The change may be from the code signifying that the drug does not present a bioequivalence problem (e.g., AA) to a code signifying a bioequivalence problem (e.g., BP), or vice versa. This procedure does not apply to a change of a particular product code (e.g., a change from BP to AB or from AB to BX). Before making a change in a therapeutic equivalence code for an entire category of drugs, the Agency will announce in the Introduction to the Cumulative Supplement that it is considering the change and will invite comment. Comments, along with scientific data, may be sent to the Director, Division of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, HFD-650, 7620 Standish Place, Rockville, MD 20855. The comment period will generally be 60 days in length, and the closing date for comments will be listed in the description of the proposed change for each drug entity. The most useful type of scientific data submission is an in vivo bioavailability/bioequivalence study conducted on batches of the subject drug products. These submissions should present a full description of the analytical procedures and equipment used, a validation of the analytical methodology, including the standard curve, a description of the method of calculating results, and a description of the pharmacokinetic and statistical models used in analyzing the data. Anecdotal or testimonial information is the least useful to the Agency, and such submissions are discouraged. Copies

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of supporting reports published in the scientific literature or unpublished material, however, are welcome.

1.10 Change of the Therapeutic Equivalence Evaluation for a Single Product The aforementioned procedure does not apply to a change in a single drug product code. For example, a change in a single drug product's code from BP to AB as a result of the submission of an acceptable bioequivalence study ordinarily will not be the subject of notice and comment. Likewise, a change in a single drug product's code from AB to BX (e.g., as a result of new information raising a significant question as to bioequivalence) does not require notice and comment. The Agency's responsibility to provide the public with the Agency's most current information related to therapeutic equivalence may require a change in a drug product's code prior to any formal notice and opportunity for the applicant to be heard. The publication in the Federal Register of a proposal to withdraw approval of a drug product will ordinarily result in a change in a product's code from AB to BX if this action has not already been taken. 1.11 Discontinued Section Those drug products in the Discontinued Section of the Orange Book in which a determination has already been made that the products were not withdrawn for safety or efficacy reasons have **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** following the product strength. Those drug products are only reflective of citizen petitions determinations made since 1995. The identification of these drug products in the Discontinued Section of the Orange Book should avoid the submission of multiple citizen petitions for the same drug product. FR notices no longer applicable are removed from the Annual Edition (i.e., there is a currently marketed Reference Listed Drug and no applicable patent or exclusivity). FR Safety or Effectiveness Determinations List lists products that have current and removed notices. The list is updated quarterly. Notices issued during the year are added to the Electronic Orange Book Query in the month they become effective. Generally, approved products are added to the Discontinued Section of the Orange Book when the applicant holder notifies the Orange Book staff of the products not marketed status. Products may also be added if annual reports indicate the product is no longer marketed or other Agency administrative action (e.g., Withdrawal of an Application). Changes to the Orange Book are not affected by the drug registration and listing requirements of Section 510 of the Act.

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1.12 Changes to the Orange Book Every effort is made to ensure the Annual Edition is current and accurate. Applicant holders are requested to inform the FDA Orange Book Staff (OBS) of any changes or corrections. Please inform the OBS when products are no longer marketed. Notification of the Orange Book staff to include the newly approved product in the Discontinued Drug Product List rather than parts 1, 2 or 3 of the List (as discussed in Section 1.1) must occur by the end of the month in which the product is approved to ensure that the product is not included in the active portions of the next published Orange Book update We can be contacted by email at drugproducts@fda.hhs.gov. FAX: 240-276-8974; mail to: FDA/CDER Orange Book Staff Office of Generic Drugs, HFD-610 7620 Standish Place Rockville, MD 20855 Send Changes by

1.13 Availability of the Edition Commencing with the 25th edition, the Annual Edition and current monthly Cumulative Supplement are available in a Portable Document Format (PDF) at the EOB home page, Electronic Orange Book Query, by clicking on Publications. The PDF annual format duplicates previous paper versions except for the Orphan Products Designations and Approvals List. An annual subscription of the PDF format may be obtained from the U.S. Government Printing Office, 866-512-1800.

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2. HOW TO USE THE DRUG PRODUCT LISTS

2.1 Key Sections for Using the Drug Product Lists

This publication contains illustrations, along with Drug Product Lists, indices, and lists of abbreviations and terms which facilitate their use. Illustrations. The annotated Drug Product Illustration, see Section 2.2, and the Therapeutic Equivalence Evaluations Illustration, see Section 2.3, are offered to provide further clarification. These depict the format found in the Prescription Drug Product List (the only list in which therapeutic equivalence evaluation codes are displayed). Drug Product Lists. The Prescription and OTC Drug Product Lists, arranged alphabetically by active ingredient(s), contain product identification information (active ingredients, dosage forms, routes of administration, product names, application holders, strengths) for single and multiple ingredient drug products. Also shown are the application number and drug product number (FDA internal computer data use only) and approval dates for those drug products approved on or after January 1, 1982. The application number preceded by N is a New Drug Application (NDA or commonly the innovator). The application number preceded by an A is an Abbreviated New Drug Application (ANDA or commonly the generic). The Discontinued Product List, arranged alphabetically by active ingredient(s), contains product identification information (dosage form, product name, strength, and application number). If a prescription drug product is available from more than one source (multisource), a therapeutic equivalence code will appear in front of the applicant's name. If a product is therapeutically equivalent to one or more products or to an appropriate reference, it will be designated with a code beginning with "A" and the entry will be underlined and printed in bold font for emphasis. Active ingredient headings for multiple ingredient (combination) drug products are arranged alphabetically. For purposes of this publication, this alphabetical sort takes precedence over United States Pharmacopeia official monograph order (i.e., Reserpine, Hydralazine Hydrochloride, Hydrochlorothiazide). For example, product information labeled as Reserpine, Hydrochlorothiazide and Hydralazine Hydrochloride appears under the active ingredient heading Hydralazine Hydrochloride; Hydrochlorothiazide; Reserpine. A cross-reference to the product information (for prescription and OTC products) appears for each additional active ingredient in the product. For combination drug products, the ingredient strengths are separated by semicolons and appear in the same relative sequence as the ingredients in the heading. Available strengths of the dosage form from an applicant appear on separate lines. To use the Drug Product Lists, determine by alphabetical order the ingredient under which the product information is listed, using the Product Name Index, if necessary. Then, find the ingredient in the applicable Drug Product List. Proceed to the dosage form and route of administration and compare products within that ingredient heading only. Therapeutic equivalence or inequivalence for prescription products is determined on the basis of the therapeutic equivalence codes provided within that specific dosage form and route heading. The OTC Drug Product List, Discontinued Drug Product List, and

2-1

Drug Products with Approval under Section 505 of the Act Administered by the Center for Biologics Evaluation and Research List have their data arranged similarly. The Discontinued Drug Product List contains approved products that have never been marketed, have been discontinued from marketing, are for military use, or have had their approvals withdrawn for other than safety or efficacy reasons subsequent to being discontinued from marketing. All products having a "@" in the 12th Cumulative Supplement of the 31st Edition List have been added to the Discontinued Drug Product List appearing in the 32nd Edition. In addition, approved drug products that are not in the commercial distribution channel e.g., approved drug products in applications for export only are also listed in the Discontinued Section of the Orange Book. Product Name Index (Prescription and OTC Drug Product Lists). This is an index of drug products by established or trade name. The second term of each entry indicates the active ingredient name under which product information can be found in the appropriate Drug Product List. For those drug products with multiple active ingredients, only the first active ingredient (in alphabetical order) will appear. OTC products are so designated. Product Name Index Listed by Applicant (Prescription and OTC Drug Product Lists). This is an index that cross-references applicants to drug products. The bolded and underlined entry represents the applicant name abbreviation used in this publication. Each complete applicant name that is represented by the abbreviated name is marked with an asterisk (*). Listed under each complete applicant name is the first alphabetically arranged ingredient under which product information can be found in the appropriate Drug Product List. OTC products are so designated. To use the Drug Product Lists, determine by alphabetical order the ingredient under which the product information is listed, using the Product Name Index, if appropriate. Uniform Terms. To improve readability, uniform terms are used to designate dosage forms, routes of administration, and abbreviations used to express strengths. These terms are listed in Appendix C. In some cases, the terms used may differ from those used in product labels and other labeling.

2-2

2.2

DRUG PRODUCT ILLUSTRATION

SINGLE INGREDIENT

ACTIVE INGREDIENT DOSAGE FORM; ROUTE OF ADMINISTRATION

MEPERIDINE HYDROCHLORIDE INJECTABLE;INJECTION HEXANON

TRADE OR GENERIC NAMES AP + PAGE PHARMA

AP + AP + REFERENCE LISTED DRUG AP + MEPERIDINE HCL GREENBERG PHARM 25MG/ML
50MG/ML
75MG/ML 100MG/ML N13111 001 N13111 002 N13111 003 AUG 22, 1983 N13111 004 JAN 04, 1985 A64890 001 A79421 001 A66331 002 AUG 27, 1987 A66331 003 A99225 001 A99226 001 A79444 001

THERAPEUTIC EQUIVALENCE (TE) CODE FOR MULTISOURCE PRODUCT FINAL APPROVAL DATE
SINGLE SOURCE PRODUCT (NO TE CODE)

AP AP AP AP

25MG/ML 50MG/ML 75MG/ML

AP

HOLOVAC LLC
RHONDA PHARM

10MG/ML 25MG/ML 150MG/ML

APPLICANT AVAILABLE STRENGTH(S) OF A PRODUCT APPLICATION NUMBER AND PRODUCT NUMBER PRODUCT NUMBER IS FOR FDA INTERNAL COMPUTER DATA USE ONLY

JOHNSON MED

100MG/ML

MULTIPLE INGREDIENTS WITH PRODUCT INFORMATION ALPHABETICALLY SORTED BY ACTIVE INGREDIENT PRODUCT INFORMATION

HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE TABLET; ORAL HYDROCHLOROTHIAZIDE, RESERPINE AND HYDRALAZINE HCL MADISON 25MG;15MG;0.1MG A69808 001 AUG 27, 1987 JAN 18, 1982

THIS EXAMPLE IS FOR PURPOSES OF ILLUSTRATION ONLY.

IT DOES NOT REPRESENT ACTUAL PRODUCTS FROM THE PRESCRIPTION DRUG PRODUCT LIST.

2.3

THERAPEUTIC EQUIVALENCE EVALUATIONS ILLUSTRATION

DRUG PRODUCTS CODED AB (OR ANY CODE BEGINNING WITH AN "A") UNDER AN INGREDIENT AND DOSAGE FORM HEADING ARE CONSIDERED THERAPEUTICALLY EQUIVALENT ONLY TO OTHER PRODUCTS CODED AB (OR ANY CODE BEGINNING WITH AN A") AND NOT TO THOSE CODED BP (OR ANY CODE BEGINNING WITH "B") AND ANY PRODUCTS NOT LISTED. DRUG PRODUCTS CODED BP (OR ANY CODE BEGINNING WITH A "B") ARE NOT CONSIDERED THERAPEUTICALLY EQUIVALENT TO ANY OTHER PRODUCT. FOR A COMPLETE EXPLANATION OF THE TE CODES REFER TO SECTION 1.7 OF THE INTRODUCTION.

SULFASALAZINE TABLET; ORAL FAZINE AB PRODUCTS CONSIDERED THERAPEUTICALLY AB EQUIVALENT TO EACH OTHER SULFASALAZINE PRODUCTS CONSIDERED NOT THERAPEUTICALLY BP BROWN 500MG A41297 001 PARKLAND SULAZINE URSA 500MG A42222 001 500MG A42999 001

EQUIVALENT TO ANY OTHER PRODUCTS LISTED SULFASALAZINE TABLET; ORAL FAZINE AB PRODUCTS CONSIDERED NOT THERAPEUTICALLY BP EQUIVALENT TO EACH OTHER SOUTH 500MG A67627 001 PARKLAND SULFASALAZINE BROWN 500MG A41297 001 500MG A42999 001

NOTE: BOLD FONT AND UNDERLINING DENOTES MULTISOURCE PRODUCTS WHICH ARE CONSIDERED THERAPEUTICALLY EQUIVALENT. THIS EXAMPLE IS FOR PURPOSES OF ILLUSTRATION ONLY. IT DOES NOT REPRESENT ACTUAL PRODUCTS FROM THE PRESCRIPTION DRUG PRODUCT LIST.

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

ABACAVIR SULFATE
SOLUTION; ORAL

ZIAGEN

XX + VIIV HLTHCARE TABLET; ORAL

ZIAGEN

XX + VIIV HLTHCARE

3 - 1 (of 424)

EQ 20MG BASE/ML

N020978 001

Dec 17, 1998

EQ 300MG BASE

N020977 001

Dec 17, 1998

ABACAVIR SULFATE; LAMIVUDINE

TABLET; ORAL

EPZICOM
XX + VIIV HLTHCARE

EQ 600MG BASE;300MG

N021652 001

Aug 02, 2004

ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE

TABLET; ORAL

TRIZIVIR

XX + VIIV HLTHCARE

EQ 300MG BASE;150MG;300MG

N021205 001

Nov 14, 2000

ABIRATERONE ACETATE
TABLET; ORAL

ZYTIGA

XX + JANSSEN BIOTECH

250MG

N202379 001

Apr 28, 2011

ACAMPROSATE CALCIUM
TABLET, DELAYED RELEASE; ORAL

CAMPRAL

333MG XX + FOREST LABS

N021431 001

Jul 29, 2004

ACARBOSE
TABLET; ORAL ACARBOSE IMPAX LABS AB AB AB MYLAN AB AB AB ROXANE AB AB AB STRIDES ARCOLAB LTD AB AB AB WATSON LABS AB AB AB PRECOSE AB + BAYER HLTHCARE AB AB

25MG 50MG 100MG 25MG 50MG 100MG 25MG 50MG 100MG 25MG 50MG 100MG 25MG 50MG 100MG 25MG 50MG 100MG

A078441 A078441 A078441 A091053 A091053 A091053 A078470 A078470 A078470 A090912 A090912 A090912 A077532 A077532 A077532

001 002 003 001 002 003 001 002 003 001 002 003 001 002 003

May May May Jan Jan Jan May May May Jul Jul Jul May May May

14, 14, 14, 06, 06, 06, 07, 07, 07, 27, 27, 27, 07, 07, 07,

2009 2009 2009 2011 2011 2011 2008 2008 2008 2011 2011 2011 2008 2008 2008

N020482 004 N020482 001 N020482 002

May 29, 1997 Sep 06, 1995 Sep 06, 1995

ACEBUTOLOL HYDROCHLORIDE
CAPSULE; ORAL ACEBUTOLOL HYDROCHLORIDE AMNEAL PHARM EQ EQ MYLAN EQ EQ WATSON LABS EQ

AB AB AB AB AB

200MG 400MG 200MG 400MG 200MG

BASE BASE BASE BASE BASE

A075047 A075047 A074288 A074288 A074007

001 002 001 002 001

Dec Dec Apr Apr Oct

30, 30, 24, 24, 18,

1999 1999 1995 1995 1995

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

ACEBUTOLOL HYDROCHLORIDE
CAPSULE; ORAL ACEBUTOLOL HYDROCHLORIDE WATSON LABS AB EQ 400MG BASE SECTRAL PROMIUS PHARMA AB EQ 200MG BASE AB + EQ 400MG BASE

3 - 2 (of 424)

A074007 002 N018917 001 N018917 003

Oct 18, 1995

Dec 28, 1984
Dec 28, 1984

ACETAMINOPHEN
SOLUTION; IV (INFUSION)
OFIRMEV
XX + CADENCE PHARMS

1000MG/100ML (10MG/ML)

N022450 001

Nov 02, 2010

ACETAMINOPHEN; BUTALBITAL

CAPSULE; ORAL

PHRENILIN FORTE
XX + VALEANT

650MG;50MG

A088831 001

Jun 19, 1985

AA AA XX XX

TABLET; ORAL BUTAPAP MIKART 325MG;50MG PHRENILIN + VALEANT 325MG;50MG BUTALBITAL AND ACETAMINOPHEN NEXGEN PHARMA 300MG;50MG BUTAPAP + MIKART 650MG;50MG

A089987 001 A087811 001 A090956 001 A089988 001

Oct 26, 1992

Jun 19, 1985
Aug 23, 2011
Oct 26, 1992

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

CAPSULE; ORAL BUTALBITAL, ACETAMINOPHEN AND CAFFEINE WEST WARD 500MG;50MG;40MG ESGIC-PLUS + MIKART 500MG;50MG;40MG BUTALBITAL, ACETAMINOPHEN AND CAFFEINE + MIKART 325MG;50MG;40MG + NEXGEN PHARMA 300MG;50MG;40MG

AA AA XX XX

A040261 001 A040085 001 A089007 001 A040885 001

Oct 28, 1998

Mar 28, 1996
Mar 17, 1986
Nov 16, 2009

SOLUTION; ORAL

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

325MG/15ML;50MG/15ML;40MG/15ML XX + MIKART TABLET; ORAL BUTALBITAL, ACETAMINOPHEN AND CAFFEINE MALLINCKRODT 325MG;50MG;40MG MIKART 325MG;50MG;40MG MIRROR PHARMS 325MG;50MG;40MG 500MG;50MG;40MG VINTAGE PHARMS 325MG;50MG;40MG 500MG;50MG;40MG WATSON LABS 500MG;50MG;40MG WEST WARD 325MG;50MG;40MG 500MG;50MG;40MG ESGIC-PLUS 500MG;50MG;40MG + MIKART FIORICET + WATSON PHARMS 325MG;50MG;40MG BUTALBITAL, ACETAMINOPHEN AND CAFFEINE + MIKART 750MG;50MG;40MG

A040387 001

Jan 31, 2003

AA AA AA AA AA AA AA AA AA AA AA XX

A087804 A089175 A040864 A040883 A040511 A040513 A040267 A089718 A040336

001 001 001 001 001 001 001 001 001

Jan Jan Dec Dec Aug Aug Jul Jun Aug

24, 21, 01, 23, 27, 25, 30, 12, 18,

1985 1987 2008 2008 2003 2003 1998 1995 1999

A089451 001 A088616 001 A040496 001

May 23, 1988 Nov 09, 1984 Dec 23, 2003

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
CAPSULE; ORAL BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE NEXGEN PHARMA INC 325MG;50MG;40MG;30MG VINTAGE PHARMS 325MG;50MG;40MG;30MG WEST WARD 325MG;50MG;40MG;30MG FIORICET W/ CODEINE + WATSON LABS INC 325MG;50MG;40MG;30MG PHRENILIN WITH CAFFEINE AND CODEINE VALEANT 325MG;50MG;40MG;30MG

3 - 3 (of 424)

AB AB AB AB AB

A076560 001 A075929 001 A075618 001 N020232 001 A074911 001

Jun 10, 2004 Apr 22, 2002 Mar 23, 2001 Jul 30, 1992 Aug 22, 2001

ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE

CAPSULE; ORAL ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE AA + MIKART 356.4MG;30MG;16MG WRASER PHARMS LLC AA 356.4MG;30MG;16MG TABLET; ORAL ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE BOCA PHARMA AA 712.8MG;60MG;32MG AA + MIKART 712.8MG;60MG;32MG

A040109 001 A040688 001

Aug 26, 1997 Apr 03, 2007

A040701 001 A040316 001

Apr 03, 2007 Apr 28, 1999

ACETAMINOPHEN; CODEINE PHOSPHATE

SOLUTION; ORAL ACETAMINOPHEN AND CODEINE PHOSPHATE HI TECH PHARMA 120MG/5ML;12MG/5ML MIKART 120MG/5ML;12MG/5ML PHARM ASSOC 120MG/5ML;12MG/5ML VINTAGE PHARMS 120MG/5ML;12MG/5ML WOCKHARDT 120MG/5ML;12MG/5ML

AA AA AA AA AA

A040119 A089450 A087508 A091238 A087006

001 001 001 001 001

Apr 26, 1996 Oct 27, 1992 Nov 10, 2011

SUSPENSION; ORAL CAPITAL AND CODEINE AA + VALEANT

120MG/5ML;12MG/5ML

A086024 001

AA AA AA AA AA AA AA AA AA AA AA AA AA AA AA XX XX

TABLET; ORAL ACETAMINOPHEN AND CODEINE PHOSPHATE AMNEAL PHARMS NY 300MG;30MG + MALLINCKRODT INC 300MG;15MG 300MG;30MG 300MG;60MG MIKART 300MG;30MG RANBAXY 300MG;30MG 300MG;60MG TEVA 300MG;15MG 300MG;30MG + 300MG;60MG VINTAGE 300MG;15MG 300MG;30MG VINTAGE PHARMS 300MG;60MG TYLENOL W/ CODEINE NO. 3 + JANSSEN PHARMS 300MG;30MG TYLENOL W/ CODEINE NO. 4 JANSSEN PHARMS 300MG;60MG ACETAMINOPHEN AND CODEINE PHOSPHATE + MIKART 650MG;30MG + 650MG;60MG

A040779 A040419 A040419 A040419 A089238 A085868 A087083 A088627 A088628 A088629 A089990 A089805 A089828

001 001 002 003 001 001 001 001 001 001 001 001 001

May May May May Feb

29, 31, 31, 31, 25,

2008 2001 2001 2001 1986

Mar Mar Mar Sep Sep Sep

06, 06, 06, 30, 30, 30,

1985 1985 1985 1988 1988 1988

A085055 003 A085055 004 A089231 001 A089363 001 Mar 03, 1986 Sep 09, 1991

ACETAMINOPHEN; HYDROCODONE BITARTRATE

CAPSULE; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN MIKART AA 500MG;5MG

A081067 001

Nov 30, 1989

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

ACETAMINOPHEN; HYDROCODONE BITARTRATE
CAPSULE; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN MIKART AA 500MG;5MG SOLUTION; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN BOCA PHARMA 325MG/15ML;7.5MG/15ML MALLINCKRODT 500MG/15ML;7.5MG/15ML + MIKART 325MG/15ML;7.5MG/15ML + 500MG/15ML;7.5MG/15ML NESHER PHARMS 500MG/15ML;7.5MG/15ML PHARM ASSOC 500MG/15ML;7.5MG/15ML VINTAGE PHARMS 500MG/15ML;7.5MG/15ML HYDROCODONE BITARTRATE AND ACETAMINOPHEN + MIKART 300MG/15ML;10MG/15ML + PHARM ASSOC 325MG/15ML;10MG/15ML

3 - 4 (of 424)

A089008 001

Feb 21, 1986

AA AA AA AA AA AA AA XX XX

A040894 A040418 A040482 A081051 A040366 A040182 A040520

001 001 001 001 001 001 001

Jul Jun Sep Aug Jan Mar Oct

19, 27, 25, 28, 23, 13, 30,

2011 2001 2003 1992 2002 1998 2003

A040881 001 A040834 001

Feb 25, 2010 Apr 18, 2008

TABLET; ORAL ANEXSIA MALLINCKRODT AA 500MG;5MG AA 750MG;10MG ANEXSIA 5/325 MALLINCKRODT AA 325MG;5MG ANEXSIA 7.5/325 MALLINCKRODT AA 325MG;7.5MG ANEXSIA 7.5/650 MALLINCKRODT AA 650MG;7.5MG CO-GESIC UCB INC AA 500MG;5MG HYDROCODONE BITARTRATE AND ACETAMINOPHEN AMNEAL PHARMS NY AA 325MG;5MG AA 325MG;10MG AA 500MG;5MG AA 500MG;7.5MG AA 500MG;10MG AA 650MG;7.5MG AA 650MG;10MG AA 750MG;7.5MG BOCA PHARMA AA 300MG;5MG AA 300MG;7.5MG AA 300MG;10MG MALLINCKRODT AA 325MG;10MG AA 500MG;5MG AA 500MG;7.5MG AA 500MG;10MG AA 650MG;10MG AA + 660MG;10MG AA 750MG;7.5MG AA + MIKART 300MG;5MG AA + 300MG;7.5MG AA + 300MG;10MG AA 325MG;7.5MG AA + 500MG;2.5MG AA + 500MG;7.5MG AA + 650MG;7.5MG AA + 650MG;10MG SUN PHARM INDS INC AA 325MG;5MG AA 325MG;7.5MG AA 325MG;10MG AA 500MG;5MG AA 500MG;7.5MG

A089160 001 A040468 001 A040409 001 A040405 001 A089725 001 A087757 001 A040736 A040746 A040729 A040748 A040813 A040754 A040757 A040769 A090415 A090415 A090415 A040400 A040084 A040201 A040201 A040084 A040084 A040084 A040658 A040556 A040556 A040432 A089698 A089699 A089689 A081223 A090118 A090118 A090118 A090265 A090265 001 001 001 001 001 001 001 001 001 002 003 001 002 001 002 004 003 001 001 002 001 001 001 001 001 001 001 002 003 001 002

Apr 23, 1987 Oct 31, 2002 Oct 20, 2000 Sep 08, 2000 Sep 30, 1987 May 03, 1982 Aug Aug Aug Aug Feb Aug Aug Aug Jan Jan Jan Jul Jun Feb Feb Oct Jul Jun Jan Mar Jun Jan Aug Aug Jun May Dec Dec Dec Dec Dec 25, 25, 25, 25, 23, 25, 25, 28, 24, 24, 24, 26, 01, 27, 27, 16, 29, 01, 19, 24, 23, 22, 25, 25, 29, 29, 23, 23, 23, 23, 23, 2006 2006 2006 2006 2007 2006 2006 2006 2011 2011 2011 2000 1995 1998 1998 1996 1996 1995 2006 2006 2004 2003 1989 1989 1988 1992 2008 2008 2008 2008 2008

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

ACETAMINOPHEN; HYDROCODONE BITARTRATE
TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN SUN PHARM INDS INC AA 500MG;10MG AA 650MG;7.5MG AA 650MG;10MG AA 660MG;10MG AA 750MG;7.5MG VINTAGE PHARMS AA 325MG;5MG AA 325MG;7.5MG AA 325MG;10MG AA 500MG;2.5MG AA 500MG;5MG AA 500MG;7.5MG AA 500MG;10MG AA 650MG;7.5MG AA 650MG;10MG AA 660MG;10MG AA 750MG;7.5MG WATSON LABS AA 500MG;2.5MG AA 500MG;5MG AA 500MG;7.5MG AA 500MG;10MG AA 650MG;7.5MG AA 650MG;10MG AA 660MG;10MG AA 750MG;7.5MG AA + 750MG;10MG WATSON LABS FLORIDA AA 660MG;10MG LORTAB UCB INC AA 500MG;5MG AA + 500MG;10MG NORCO AA + WATSON LABS 325MG;5MG AA + 325MG;7.5MG AA + 325MG;10MG VICODIN AA + ABBOTT 500MG;5MG VICODIN ES AA + ABBOTT 750MG;7.5MG VICODIN HP ABBOTT AA 660MG;10MG HYDROCODONE BITARTRATE AND ACETAMINOPHEN MIKART 325MG;2.5MG XX 650MG;5MG XX ZYDONE 400MG;5MG XX + ENDO PHARMS 400MG;7.5MG XX + 400MG;10MG XX +

3 - 5 (of 424)

A090265 A090380 A090380 A090380 A090380 A040655 A040656 A040355 A040144 A089971 A040144 A040356 A040155 A040143 A040358 A040157 A081079 A089883 A081080 A040148 A040094 A040094 A040094 A081083 A040094 A040495

003 001 002 003 004 001 001 001 002 001 001 001 001 001 001 001 001 001 001 002 001 002 003 001 004 001

Dec Dec Dec Dec Dec Jan Jan May Apr Dec Feb May Apr Feb May Apr Aug Dec Aug Feb Sep Sep Aug Aug Mar May

23, 23, 23, 23, 23, 19, 19, 31, 25, 02, 22, 31, 14, 22, 31, 12, 30, 01, 30, 14, 29, 29, 08, 30, 22, 28,

2008 2008 2008 2008 2008 2006 2006 2000 1997 1988 1996 2000 1997 1996 2000 1996 1991 1988 1991 1997 1995 1995 2000 1991 1999 2003

A087722 001 A040100 001 A040099 001 A040148 003 A040148 001 A088058 001 A089736 001 A040117 001 A040846 001 A040849 001 A040288 001 A040288 002 A040288 003

Jul 09, 1982 Jan 26, 1996 Jun 25, 1997 Sep 12, 2000 Feb 14, 1997 Jan 07, 1983 Dec 09, 1988 Sep 23, 1996 Jun 09, 2010 Jun 09, 2010 Nov 27, 1998 Nov 27, 1998 Nov 27, 1998

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

CAPSULE; ORAL OXYCODONE AND ACETAMINOPHEN DURAMED PHARMS BARR 500MG;5MG MALLINCKRODT 500MG;5MG VINTAGE PHARMS 500MG;5MG WATSON LABS 500MG;5MG ROXILOX ROXANE 500MG;5MG

AA AA AA AA AA

A040289 A040257 A040106 A040234

001 001 001 001

Mar Aug Jul Oct

16, 04, 30, 30,

1999 1998 1996 1997

A040061 001

Jul 03, 1995

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
CAPSULE; ORAL TYLOX AA + JANSSEN PHARMS SOLUTION; ORAL ROXICET AA + ROXANE

3 - 6 (of 424)

500MG;5MG

A088790 001

Dec 12, 1984

325MG/5ML;5MG/5ML

A089351 001

Dec 03, 1986

AA AA AA AA AA AA AA AA AA AA AA AA AA AA AA AA AA AA AA AA AA AA AA AA AA AA AA AA XX XX XX XX XX XX XX XX XX XX

TABLET; ORAL OXYCET MALLINCKRODT 325MG;5MG OXYCODONE AND ACETAMINOPHEN AMNEAL PHARMS NY 325MG;5MG 325MG;10MG 500MG;7.5MG 650MG;10MG COASTAL PHARMS 325MG;2.5MG 325MG;5MG 325MG;7.5MG 325MG;10MG 500MG;7.5MG 650MG;10MG MALLINCKRODT 325MG;7.5MG 325MG;10MG 500MG;7.5MG 650MG;10MG VINTAGE PHARMS 325MG;5MG WATSON LABS 325MG;5MG 325MG;7.5MG 325MG;10MG 500MG;7.5MG 650MG;10MG PERCOCET + ENDO PHARMS 325MG;2.5MG + 325MG;5MG + 325MG;7.5MG + 325MG;10MG + 500MG;7.5MG + 650MG;10MG ROXICET ROXANE 325MG;5MG OXYCODONE AND ACETAMINOPHEN + MIKART 300MG;2.5MG + 300MG;5MG + 300MG;7.5MG + 300MG;10MG + 400MG;2.5MG + 400MG;5MG + 400MG;7.5MG + 400MG;10MG 500MG;10MG ROXICET 5/500 + ROXANE 500MG;5MG

A087463 001 A040777 A040778 A040789 A040789 A090177 A090177 A090177 A090177 A090177 A090177 A040545 A040545 A040550 A040550 A040105 A040171 A040535 A040535 A040371 A040371 A040330 A040330 A040434 A040434 A040341 A040341 001 001 001 002 001 002 003 004 005 006 001 002 001 002 001 001 001 002 001 002 001 002 001 002 001 002

Dec 07, 1983 Nov Nov Nov Nov Oct Oct Oct Oct Oct Oct Jun Jun Jun Jun Jul Oct Sep Sep Dec Dec Jun Jun Nov Nov Jul Jul 27, 27, 27, 27, 20, 20, 20, 20, 20, 20, 30, 30, 30, 30, 30, 30, 05, 05, 29, 29, 25, 25, 23, 23, 26, 26, 2007 2007 2007 2007 2008 2008 2008 2008 2008 2008 2004 2004 2004 2004 1996 1997 2003 2003 2000 2000 1999 1999 2001 2001 1999 1999

A087003 001 A040608 A040608 A040608 A040608 A040679 A040687 A040698 A040692 A040676 001 002 003 004 001 001 001 001 001 Dec Dec Dec Dec May Apr Apr Apr Apr 30, 30, 30, 30, 16, 27, 27, 27, 19, 2005 2005 2005 2005 2006 2006 2006 2006 2006

A089775 001

Jan 12, 1989

ACETAMINOPHEN; PENTAZOCINE HYDROCHLORIDE

TABLET; ORAL ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE GAVIS PHARMS AB 650MG;EQ 25MG BASE AB + WATSON LABS 650MG;EQ 25MG BASE

A076202 001 A074699 001

Aug 02, 2002

Mar 24, 2000

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
TABLET; ORAL TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN AMNEAL PHARMS 325MG;37.5MG CARACO 325MG;37.5MG MYLAN 325MG;37.5MG PAR PHARM 325MG;37.5MG WATSON LABS 325MG;37.5MG ULTRACET + JANSSEN PHARMS 325MG;37.5MG

3 - 7 (of 424)

AB AB AB AB AB AB

A090485 A077184 A077858 A076475 A076914

001 001 001 001 001

Dec Dec Sep Apr Jul

09, 16, 26, 21, 26,

2009 2005 2008 2005 2006

N021123 001

Aug 15, 2001

ACETAZOLAMIDE
CAPSULE, EXTENDED RELEASE; ORAL ACETAZOLAMIDE HERITAGE PHARMS INC AB 500MG ZYDUS PHARMS USA INC 500MG AB DIAMOX AB + DURAMED PHARMS BARR 500MG TABLET; ORAL ACETAZOLAMIDE LANNETT MUTUAL PHARM TARO + WATSON LABS

A090779 001 A040904 001 N012945 001

Jul 14, 2011 Dec 10, 2008

AB AB AB AB AB

250MG 125MG 125MG 250MG 250MG

A084840 A089752 A040195 A040195 A088882

001 001 001 002 001

Jun May May Oct

22, 28, 28, 22,

1988 1997 1997 1985

ACETAZOLAMIDE SODIUM
INJECTABLE; INJECTION ACETAZOLAMIDE SODIUM BEDFORD AP X GEN PHARMS AP DIAMOX AP + DURAMED PHARMS BARR

EQ 500MG BASE/VIAL EQ 500MG BASE/VIAL EQ 500MG BASE/VIAL

A040089 001 A040784 001 N009388 001

Feb 28, 1995 Dec 10, 2008 Dec 05, 1990

ACETIC ACID, GLACIAL

SOLUTION; IRRIGATION, URETHRAL ACETIC ACID 0.25% IN PLASTIC CONTAINER B BRAUN AT 250MG/100ML BAXTER HLTHCARE AT 250MG/100ML HOSPIRA AT 250MG/100ML SOLUTION/DROPS; OTIC ACETIC ACID TARO VINTAGE + WOCKHARDT VOSOL HI TECH PHARMA

N018161 001 N018523 001 N017656 001

Feb 19, 1982

AT AT AT AT

2% 2% 2% 2%

A088638 001 A040607 001 A040166 001 N012179 001

Sep 06, 1984 Feb 24, 2005 Jul 26, 1996

ACETIC ACID, GLACIAL; ALUMINUM ACETATE

SOLUTION/DROPS; OTIC
ACETIC ACID 2% IN AQUEOUS ALUMINUM ACETATE
XX + BAUSCH AND LOMB 2%;0.79%

A040063 001

Feb 25, 1994

ACETIC ACID, GLACIAL; HYDROCORTISONE

SOLUTION/DROPS; OTIC ACETASOL HC ACTAVIS MID ATLANTIC 2%;1% AT HYDROCORTISONE AND ACETIC ACID TARO AT 2%;1%

A087143 001 A088759 001

Jan 13, 1982 Mar 04, 1985

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

ACETIC ACID, GLACIAL; HYDROCORTISONE
SOLUTION/DROPS; OTIC HYDROCORTISONE AND ACETIC ACID VINTAGE AT 2%;1% VOSOL HC AT + HI TECH PHARMA 2%;1%

3 - 8 (of 424)

A040609 001 N012770 001

Feb 06, 2006

ACETOHEXAMIDE
TABLET; ORAL ACETOHEXAMIDE WATSON LABS XX XX +

250MG 500MG

A071893 001 A071894 001

Nov 25, 1987 Nov 25, 1987

ACETOHYDROXAMIC ACID
TABLET; ORAL
LITHOSTAT
XX + MISSION PHARMA

250MG

N018749 001

May 31, 1983

ACETYLCHOLINE CHLORIDE
FOR SOLUTION; OPHTHALMIC
MIOCHOL-E
XX + BAUSCH AND LOMB

20MG/VIAL

N020213 001

Sep 22, 1993

ACETYLCYSTEINE
INJECTABLE; INTRAVENOUS
ACETADOTE
XX + CUMBERLAND PHARMS

6GM/30ML (200MG/ML)

N021539 001

Jan 23, 2004

SOLUTION; INHALATION, ORAL ACETYLCYSTEINE BEDFORD AN 10% AN 20% HOSPIRA AN 10% AN 20% AN + LUITPOLD 10% AN + 20%

A072323 A072324 A073664 A074037 A072489 A072547

001 001 001 001 001 001

Apr Apr Aug Aug Jul Jul

30, 30, 30, 30, 28, 28,

1992 1992 1994 1994 1995 1995

ACITRETIN
CAPSULE; ORAL
SORIATANE
STIEFEL LABS INC XX XX XX XX +

10MG 17.5MG 22.5MG 25MG

N019821 N019821 N019821 N019821

001 003 004 002

Oct Aug Aug Oct

28, 06, 06, 28,

1996 2009 2009 1996

ACRIVASTINE; PSEUDOEPHEDRINE HYDROCHLORIDE

CAPSULE; ORAL
SEMPREX-D
XX + UCB INC

8MG;60MG

N019806 001

Mar 25, 1994

ACYCLOVIR
CAPSULE; ORAL ACYCLOVIR APOTEX INC AB DAVA PHARMS INC AB MYLAN AB AB RANBAXY AB STASON AB TEVA AB

200MG 200MG 200MG 200MG 200MG 200MG 200MG

A075677 A074833 A074727 A074977 A074975 A075090 A074578

001 001 001 001 001 001 001

Sep Apr Apr Apr Sep Jan Apr

28, 22, 22, 13, 30, 26, 22,

2005 1997 1997 1998 1998 1999 1997

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

ACYCLOVIR
CAPSULE; ORAL ACYCLOVIR WATSON LABS AB ZOVIRAX AB + GLAXOSMITHKLINE CREAM; TOPICAL

ZOVIRAX

XX + VALEANT INTL OINTMENT; TOPICAL

ZOVIRAX

XX + VALEANT INTL SUSPENSION; ORAL ACYCLOVIR ACTAVIS MID ATLANTIC AB HI TECH PHARMA AB ZOVIRAX AB + GLAXOSMITHKLINE TABLET; ORAL ACYCLOVIR APOTEX INC AB AB CARLSBAD AB AB DAVA PHARMS INC AB AB MYLAN AB AB AB AB RANBAXY AB AB TEVA AB AB ZOVIRAX GLAXOSMITHKLINE AB AB +

3 - 9 (of 424)

200MG 200MG

A075101 001 N018828 001

Apr 15, 1998 Jan 25, 1985

5%

N021478 001

Dec 30, 2002

5%

N018604 001

Mar 29, 1982

200MG/5ML 200MG/5ML 200MG/5ML

A074738 001 A077026 001 N019909 001

Apr 28, 1997 Jun 07, 2005 Dec 22, 1989

400MG 800MG 400MG 800MG 400MG 800MG 400MG 400MG 800MG 800MG 400MG 800MG 400MG 800MG 400MG 800MG

A077309 A077309 A075382 A075382 A074946 A074946 A074976 A075211 A074976 A075211 A074980 A074980 A074556 A074556

001 002 001 002 001 002 001 001 002 002 001 002 002 003

Sep Sep Apr Apr Nov Nov Apr Sep Apr Sep Sep Sep Apr Apr

29, 29, 30, 30, 19, 19, 13, 28, 13, 28, 30, 30, 22, 22,

2005 2005 1999 1999 1997 1997 1998 1998 1998 1998 1998 1998 1997 1997

N020089 001 N020089 002

Apr 30, 1991 Apr 30, 1991

ACYCLOVIR SODIUM
INJECTABLE; INJECTION ACYCLOVIR SODIUM AP + APP PHARMS EQ 50MG BASE/ML AP + EQ 500MG BASE/VIAL BAXTER HLTHCARE AP EQ 500MG BASE/VIAL AP EQ 1GM BASE/VIAL BEDFORD AP EQ 500MG BASE/VIAL AP EQ 1GM BASE/VIAL ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE EQ 500MG BASE/VIAL XX + BAXTER HLTHCARE EQ 1GM BASE/VIAL XX

A074930 A075015 A074913 A074913 A074596 A074596

001 001 001 002 002 001

May Apr Oct Oct Apr Apr

13, 30, 15, 15, 22, 22,

1998 1998 1997 1997 1997 1997

A074885 001 A074885 002

Dec 19, 1997 Dec 19, 1997

ACYCLOVIR; HYDROCORTISONE
CREAM; TOPICAL

XERESE

XX + VALEANT INTL

5%;1%

N022436 001

Jul 31, 2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

ADAPALENE
CREAM; TOPICAL ADAPALENE NYCOMED US AB DIFFERIN AB + GALDERMA LABS LP GEL; TOPICAL ADAPALENE GLENMARK GENERICS PLIVA HRVATSKA DOO DIFFERIN + GALDERMA LABS LP DIFFERIN + GALDERMA LABS LP

3 - 10 (of 424)

0.1% 0.1%

A090824 001 N020748 001

Jun 30, 2010 May 26, 2000

AB AB AB XX

0.1% 0.1% 0.1% 0.3%

A091314 001 A090962 001 N020380 001 N021753 001

Jul 01, 2010 Jun 02, 2010 May 31, 1996 Jun 19, 2007

LOTION; TOPICAL

DIFFERIN
XX + GALDERMA R AND D

0.1%

N022502 001

Mar 17, 2010

ADAPALENE; BENZOYL PEROXIDE

GEL; TOPICAL

EPIDUO
XX + GALDERMA LABS

0.1%;2.5%

N022320 001

Dec 08, 2008

ADEFOVIR DIPIVOXIL

TABLET; ORAL

HEPSERA
XX + GILEAD

10MG

N021449 001

Sep 20, 2002

ADENOSINE
INJECTABLE; INJECTION ADENOCARD + ASTELLAS ADENOSINE AKORN APP PHARMS BAXTER HLTHCARE BEDFORD GLAND PHARMA LTD LUITPOLD STRIDES ARCOLAB LTD TEVA PARENTERAL WOCKHARDT ADENOSCAN + ASTELLAS

AP AP AP AP AP AP AP AP AP AP AP XX

3MG/ML 3MG/ML 3MG/ML 3MG/ML 3MG/ML 3MG/ML 3MG/ML 3MG/ML 3MG/ML 3MG/ML 3MG/ML 3MG/ML

N019937 002 A078076 A077133 A076500 A076404 A077283 A090010 A078686 A076564 A078676 A090220 001 001 001 001 001 001 001 001 001 001

Oct 30, 1989 Oct Apr Jun Jun Jun Apr May Jun Jul Jul 31, 27, 16, 16, 14, 28, 13, 16, 31, 20, 2008 2005 2004 2004 2007 2009 2009 2004 2008 2009

N020059 001

May 18, 1995

ALBENDAZOLE

TABLET; ORAL

ALBENZA
XX + COREPHARMA

200MG

N020666 001

Jun 11, 1996

ALBUMIN HUMAN

INJECTABLE; INJECTION

OPTISON
XX + GE HEALTHCARE

10MG/ML

N020899 001

Dec 31, 1997

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

ALBUMIN IODINATED I-125 SERUM
INJECTABLE; INJECTION JEANATOPE ISO TEX XX XX XX +

3 - 11 (of 424)

100UCI/10ML (10UCI/ML) 500uCi/0.5ML 1,000uCi/ML

N017836 003 N017836 001 N017836 002

Jun 08, 2004

ALBUMIN IODINATED I-131 SERUM

INJECTABLE; INJECTION

MEGATOPE

XX + ISO TEX XX +

0.5mCi/VIAL 1mCi/VIAL

N017837 001 N017837 002

ALBUTEROL SULFATE
AEROSOL, METERED; INHALATION PROAIR HFA BX + TEVA GLOBAL EQ 0.09MG BASE/INH PROVENTIL-HFA BX + 3M EQ 0.09MG BASE/INH VENTOLIN HFA BX + GLAXOSMITHKLINE EQ 0.09MG BASE/INH SOLUTION; INHALATION ACCUNEB AN + DEY AN + ALBUTEROL SULFATE APOTEX INC AN AN AN AN + BAUSCH AND LOMB AN + DEY HI TECH PHARMA AN AN LANDELA PHARM AN NEPHRON AN AN AN AN NOVEX AN RITEDOSE CORP AN TEVA PARENTERAL AN WATSON LABS AN AN WATSON LABS INC AN WOCKHARDT AN SYRUP; ORAL ALBUTEROL SULFATE ACTAVIS MID ATLANTIC AMNEAL PHARMS HI TECH PHARMA + TEVA VINTAGE VISTAPHARM

N021457 001 N020503 001 N020983 001

Oct 29, 2004 Aug 15, 1996 Apr 19, 2001

EQ 0.021% BASE EQ 0.042% BASE EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ 0.021% BASE 0.042% BASE 0.083% BASE 0.5% BASE 0.083% BASE 0.083% BASE 0.5% BASE 0.083% BASE 0.021% BASE 0.042% BASE 0.083% BASE 0.5% BASE 0.5% BASE 0.083% BASE 0.083% BASE 0.021% BASE 0.042% BASE 0.083% BASE 0.083% BASE

N020949 002 N020949 001 A078623 A078623 A075717 A075050 A072652 A075063 A074543 A077569 A076355 A076355 A074880 A075664 A076391 A077839 A075343 A077772 A077772 A076370 A075394 001 002 001 001 001 001 001 001 002 001 001 001 001 001 001 001 002 001 001

Apr 30, 2001 Apr 30, 2001 Apr Apr Feb Jun Feb Feb Jan Apr Mar Jun Sep Jun Apr Dec Nov Sep Sep Nov Nov 05, 05, 02, 18, 21, 09, 15, 04, 31, 28, 17, 26, 01, 16, 09, 25, 25, 24, 22, 2010 2010 2007 1998 1992 1999 1998 2006 2010 2004 1997 2001 2003 2008 1999 2007 2007 2003 1999

AA AA AA AA AA AA

EQ EQ EQ EQ EQ EQ

2MG 2MG 2MG 2MG 2MG 2MG

BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML

A074454 A079241 A074749 A073419 A078105 A077788

001 001 001 001 001 001

Sep May Jan Mar Dec Jun

25, 12, 30, 30, 27, 26,

1995 2010 1998 1992 2006 2007

TABLET; ORAL ALBUTEROL SULFATE MUTUAL PHARM AB AB MYLAN AB AB +

EQ EQ EQ EQ

2MG 4MG 2MG 4MG

BASE BASE BASE BASE

A072637 A072637 A072894 A072894

002 001 002 001

Dec Dec Jan Jan

05, 05, 17, 17,

1989 1989 1991 1991

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

ALBUTEROL SULFATE
TABLET; ORAL ALBUTEROL SULFATE WATSON LABS AB

3 - 12 (of 424)

EQ 2MG BASE

A072764 001

Aug 28, 1991

TABLET, EXTENDED RELEASE; ORAL ALBUTEROL SULFATE MYLAN AB EQ 4MG AB EQ 8MG VOSPIRE ER DAVA PHARMS INC AB EQ 4MG AB + EQ 8MG

BASE BASE BASE BASE

A078092 002 A078092 001 A076130 002 A076130 003

Jan 29, 2007

Jan 29, 2007
Sep 26, 2002
Sep 26, 2002

ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

AEROSOL, METERED; INHALATION
COMBIVENT
XX + BOEHRINGER INGELHEIM EQ 0.09MG BASE/INH;0.018MG/INH SOLUTION; INHALATION ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE APOTEX CORP EQ 0.083% BASE;0.017% NEPHRON EQ 0.083% BASE;0.017% SANDOZ EQ 0.083% BASE;0.017% TEVA PARENTERAL EQ 0.083% BASE;0.017% WATSON LABS EQ 0.083% BASE;0.017% EQ 0.083% BASE;0.017% DUONEB + DEY EQ 0.083% BASE;0.017%

N020291 001

Oct 24, 1996

AN AN AN AN AN AN AN

A077117 A076749 A076867 A076724 A077063 A077559

001 001 001 001 001 001

Dec Dec Dec Dec Dec Dec

31, 31, 21, 31, 31, 31,

2007 2007 2006 2007 2007 2007

N020950 001

Mar 21, 2001

SPRAY, METERED; INHALATION

COMBIVENT RESPIMAT
XX + BOEHRINGER INGELHEIM EQ 0.1MG BASE/INH;0.02MG/INH

N021747 001

Oct 07, 2011

ALCAFTADINE
SOLUTION/DROPS; OPHTHALMIC
LASTACAFT
XX + ALLERGAN 0.25%

N022134 001

Jul 28, 2010

ALCLOMETASONE DIPROPIONATE
CREAM; TOPICAL ACLOVATE + FOUGERA PHARMS 0.05% ALCLOMETASONE DIPROPIONATE ALTANA 0.05% GLENMARK GENERICS 0.05% TARO 0.05% OINTMENT; TOPICAL ACLOVATE + FOUGERA PHARMS 0.05% ALCLOMETASONE DIPROPIONATE ALTANA 0.05% GLENMARK GENERICS 0.05% TARO 0.05%

AB AB AB AB

N018707 001 A076973 001 A079061 001 A076587 001

Dec 14, 1982 Jul 12, 2005 Jun 23, 2009 Sep 15, 2005

AB AB AB AB

N018702 001 A076884 001 A079227 001 A076730 001

Dec 14, 1982 Jul 18, 2005 Jul 30, 2009 Jul 29, 2004

ALCOHOL; DEXTROSE
INJECTABLE; INJECTION ALCOHOL 5% AND DEXTROSE 5% AP + B BRAUN 5ML/100ML;5GM/100ML ALCOHOL 10% AND DEXTROSE 5% 10ML/100ML;5GM/100ML XX + B BRAUN

N004589 004 N004589 006

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

ALENDRONATE SODIUM
SOLUTION; ORAL

FOSAMAX

XX + MERCK TABLET; ORAL ALENDRONATE SODIUM APOTEX AB AB AB AB AUROBINDO PHARMA AB AB AB AUSTARPHARMA LLC AB AB AB AB CADISTA PHARMS AB AB AB AB DR REDDYS LABS LTD AB AB AB AB MYLAN AB AB AB AB AB AB SUN PHARMA GLOBAL AB AB AB AB TEVA PHARMS AB AB AB AB AB WATSON LABS AB AB AB AB AB AB AB AB FOSAMAX MERCK AND CO INC AB AB AB AB AB +

3 - 13 (of 424)

EQ 70MG BASE/75ML

N021575 001

Sep 17, 2003

EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ

5MG BASE 10MG BASE 35MG BASE 70MG BASE 10MG BASE 35MG BASE 70MG BASE 5MG BASE 10MG BASE 35MG BASE 70MG BASE 5MG BASE 10MG BASE 35MG BASE 70MG BASE 5MG BASE 10MG BASE 35MG BASE 70MG BASE 5MG BASE 10MG BASE 35MG BASE 35MG BASE 70MG BASE 70MG BASE 5MG BASE 10MG BASE 35MG BASE 70MG BASE 5MG BASE 10MG BASE 35MG BASE 40MG BASE 70MG BASE 5MG BASE 10MG BASE 35MG BASE 35MG BASE 40MG BASE 40MG BASE 70MG BASE 70MG BASE 5MG BASE 10MG BASE 35MG BASE 40MG BASE 70MG BASE

A077982 A077982 A077982 A077982 A090124 A090124 A090124 A090258 A090258 A090258 A090258 A090557 A090557 A090557 A090557 A079109 A079109 A079049 A079049 A076584 A076584 A076584 A078638 A076584 A078638 A090022 A090022 A090022 A090022 A075710 A075710 A075710 A075710 A075710 A076768 A076768 A076768 A076984 A076768 A076984 A076768 A076984 N020560 N020560 N020560 N020560 N020560

001 002 003 004 001 002 003 001 002 003 004 001 002 003 004 001 002 001 002 001 002 003 001 004 002 001 002 003 004 001 002 003 004 005 001 002 003 001 004 002 005 003 003 001 004 002 005

Aug Aug Aug Aug Aug Aug Aug Sep Sep Sep Sep Feb Feb Feb Feb Aug Aug Aug Aug Aug Aug Aug Aug Aug Aug Sep Sep Sep Sep Feb Feb Feb Feb Feb Aug Aug Aug Aug Aug Aug Aug Aug Apr Sep Oct Sep Oct

04, 04, 04, 04, 04, 04, 04, 24, 24, 24, 24, 18, 18, 18, 18, 04, 04, 04, 04, 04, 04, 04, 04, 04, 04, 10, 10, 10, 10, 06, 06, 06, 06, 06, 04, 04, 04, 04, 04, 04, 04, 04, 25, 29, 20, 29, 20,

2008 2008 2008 2008 2008 2008 2008 2009 2009 2009 2009 2010 2010 2010 2010 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 1997 1995 2000 1995 2000

ALENDRONATE SODIUM; CHOLECALCIFEROL

TABLET; ORAL FOSAMAX PLUS D MERCK XX XX +

EQ 70MG BASE;2,800 IU EQ 70MG BASE;5,600 IU

N021762 001 N021762 002

Apr 07, 2005 Apr 26, 2007

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

ALFENTANIL HYDROCHLORIDE
INJECTABLE; INJECTION ALFENTA AP + AKORN ALFENTANIL HOSPIRA AP

3 - 14 (of 424)

EQ 0.5MG BASE/ML EQ 0.5MG BASE/ML

N019353 001 A075221 001

Dec 29, 1986 Oct 28, 1999

ALFUZOSIN HYDROCHLORIDE
TABLET, EXTENDED RELEASE; ALFUZOSIN HYDROCHLORIDE APOTEX INC MYLAN SUN PHARMA GLOBAL TEVA PHARMS TORRENT PHARMS UROXATRAL + SANOFI AVENTIS US ORAL 10MG 10MG 10MG 10MG 10MG 10MG A079013 A079014 A079057 A079056 A079054 001 001 001 001 001 Jul Jul Jul Jul Jul 18, 18, 18, 18, 18, 2011 2011 2011 2011 2011

AB AB AB AB AB AB

N021287 001

Jun 12, 2003

ALGLUCERASE
INJECTABLE; INJECTION
CEREDASE
XX + GENZYME

80 UNITS/ML

N020057 003

Apr 05, 1991

ALISKIREN HEMIFUMARATE
TABLET; ORAL
TEKTURNA
XX NOVARTIS
XX +

EQ 150MG BASE EQ 300MG BASE

N021985 001 N021985 002

Mar 05, 2007 Mar 05, 2007

ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE

TABLET; ORAL TEKAMLO NOVARTIS XX XX XX XX +

EQ EQ EQ EQ

150MG 150MG 300MG 300MG

BASE;EQ BASE;EQ BASE;EQ BASE;EQ

5MG BASE 10MG BASE 5MG BASE 10MG BASE

N022545 N022545 N022545 N022545

001 002 003 004

Aug Aug Aug Aug

26, 26, 26, 26,

2010 2010 2010 2010

ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE

TABLET; ORAL AMTURNIDE NOVARTIS XX XX XX XX XX +

EQ EQ EQ EQ EQ

150MG 300MG 300MG 300MG 300MG

BASE;EQ BASE;EQ BASE;EQ BASE;EQ BASE;EQ

5MG BASE;12.5MG 5MG BASE;12.5MG 5MG BASE;25MG 10MG BASE;12.5MG 10MG BASE;25MG

N200045 N200045 N200045 N200045 N200045

001 002 003 004 005

Dec Dec Dec Dec Dec

21, 21, 21, 21, 21,

2010 2010 2010 2010 2010

ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE

TABLET; ORAL
TEKTURNA HCT
NOVARTIS XX XX XX + XX +

EQ EQ EQ EQ

150MG 150MG 300MG 300MG

BASE;12.5MG
BASE;25MG
BASE;12.5MG BASE;25MG

N022107 N022107 N022107 N022107

001 002 003 004

Jan Jan Jan Jan

18, 18, 18, 18,

2008 2008 2008 2008

ALISKIREN HEMIFUMARATE; VALSARTAN

TABLET; ORAL
VALTURNA
NOVARTIS XX XX +

EQ 150MG BASE;160MG
EQ 300MG BASE;320MG

N022217 001 N022217 002

Sep 16, 2009

Sep 16, 2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

ALITRETINOIN
GEL; TOPICAL
PANRETIN
XX + EISAI INC

3 - 15 (of 424)

EQ 0.1% BASE

N020886 001

Feb 02, 1999

ALLOPURINOL
TABLET; ORAL ALLOPURINOL APOTEX INC AB AB CARACO AB AB IPCA LABS LTD AB AB MUTUAL PHARM AB AB MYLAN AB AB NORTHSTAR HLTHCARE AB AB VINTAGE PHARMS AB AB WATSON LABS AB AB LOPURIN DR REDDYS LA AB AB ZYLOPRIM PROMETHEUS LABS AB AB +

100MG 300MG 100MG 300MG 100MG 300MG 100MG 300MG 100MG 300MG 100MG 300MG 100MG 300MG 100MG 300MG 100MG 300MG 100MG 300MG

A077353 A077353 A078390 A078390 A090637 A090637 A071449 A071450 N018659 N018659 A078253 A078253 A075798 A075798 N018832 N018877

001 002 001 002 001 002 001 001 001 002 001 002 001 002 002 001

Sep Sep Aug Aug Mar Mar Jan Jan Oct Oct Sep Sep Jun Jun Sep Sep

08, 08, 30, 30, 16, 16, 09, 09, 24, 24, 11, 11, 27, 27, 28, 28,

2005 2005 2007 2007 2011 2011 1987 1987 1986 1986 2007 2007 2003 2003 1984 1984

A071586 001 A071587 001 N016084 001 N016084 002

Apr 02, 1987 Apr 02, 1987

ALLOPURINOL SODIUM
INJECTABLE; INJECTION ALLOPURINOL SODIUM BEDFORD LABS AP ALOPRIM AP + MYLAN INSTITUTIONAL

EQ 500MG BASE/VIAL EQ 500MG BASE/VIAL

A076870 001 N020298 001

Aug 26, 2004 May 17, 1996

ALMOTRIPTAN MALATE
TABLET; ORAL AXERT JANSSEN PHARMS XX XX +

EQ 6.25MG BASE EQ 12.5MG BASE

N021001 001 N021001 002

May 07, 2001 May 07, 2001

ALOSETRON HYDROCHLORIDE
TABLET; ORAL LOTRONEX PROMETHEUS LABS XX XX +

EQ 0.5MG BASE EQ 1MG BASE

N021107 002 N021107 001

Dec 23, 2003 Feb 09, 2000

ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE; VITAMIN K
INJECTABLE; INJECTION
INFUVITE ADULT
XX + SANDOZ

2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1 .2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;0.03MG/ML

N021163 001

May 18, 2000

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 16 (of 424)

ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE; VITAMIN K
INJECTABLE; IV (INFUSION)
INFUVITE ADULT
XX + SANDOZ 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1 .2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;30MCG/ML

N021559 001

Jun 16, 2003

ALPRAZOLAM
CONCENTRATE; ORAL

ALPRAZOLAM

XX + ROXANE TABLET; ORAL ALPRAZOLAM ACTAVIS ELIZABETH AB AB AB AB ALPHAPHARM AB AB AB AB APOTEX INC AB AB AB AB BOCA PHARMA AB AB AB AB DAVA INTL INC AB AB AB AB MYLAN AB AB AB AB SANDOZ AB AB AB AB SUN PHARMA GLOBAL AB AB AB AB VINTAGE AB AB AB AB XANAX PHARMACIA AND UPJOHN AB AB AB + AB

1MG/ML

A074312 001

Oct 31, 1993

0.25MG 0.5MG 1MG 2MG 0.25MG 0.5MG 1MG 2MG 0.25MG 0.5MG 1MG 2MG 0.25MG 0.5MG 1MG 2MG 0.25MG 0.5MG 1MG 2MG 0.25MG 0.5MG 1MG 2MG 0.25MG 0.5MG 1MG 2MG 0.25MG 0.5MG 1MG 2MG 0.25MG 0.5MG 1MG 2MG 0.25MG 0.5MG 1MG 2MG

A074342 A074342 A074342 A074342 A074046 A074046 A074046 A074046 A077741 A077741 A077741 A077741 A090248 A090248 A090248 A090248 A074174 A074174 A074174 A074174 A074215 A074215 A074215 A074215 A074112 A074112 A074112 A074909 A090082 A090082 A090082 A090082 A078491 A078491 A078491 A078491 N018276 N018276 N018276 N018276

001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 001 001 002 003 004 001 002 003 004 001 002 003 004

Oct Oct Oct Oct Oct Oct Oct May Jan Jan Jan Jan Sep Sep Sep Sep Oct Oct Oct Oct Jan Jan Jan Jan Dec Dec Dec Mar Jun Jun Jun Jun Sep Sep Sep Dec

31, 31, 31, 31, 19, 19, 19, 07, 19, 19, 19, 19, 17, 17, 17, 17, 19, 19, 19, 19, 27, 27, 27, 27, 29, 29, 29, 25, 17, 17, 17, 17, 25, 25, 25, 12,

1993 1993 1993 1993 1993 1993 1993 1997 2007 2007 2007 2007 2010 2010 2010 2010 1993 1993 1993 1993 1994 1994 1994 1994 1995 1995 1995 1998 2010 2010 2010 2010 2008 2008 2008 2008

Nov 27, 1985

TABLET, EXTENDED RELEASE; ORAL ALPRAZOLAM ACTAVIS ELIZABETH AB 0.5MG AB 1MG

A078056 001 A078056 002

Feb 13, 2007 Feb 13, 2007

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

ALPRAZOLAM
TABLET, EXTENDED RELEASE; ORAL ALPRAZOLAM ACTAVIS ELIZABETH AB 2MG AB 3MG AMNEAL PHARMS NY AB 0.5MG AB 1MG AB 2MG AB 3MG ANCHEN PHARMS AB 0.5MG AB 1MG AB 2MG AB 3MG APOTEX INC AB 0.5MG AB 2MG AB 3MG AUROBINDO PHARMA USA 0.5MG AB AB 1MG AB 2MG AB 3MG BARR AB 0.5MG AB 1MG AB 2MG AB 3MG COREPHARMA AB 0.5MG AB 1MG AB 2MG AB 3MG IMPAX LABS AB 0.5MG AB 1MG AB 2MG AB 3MG MYLAN AB 0.5MG AB 1MG AB 2MG AB 3MG SANDOZ AB 0.5MG AB 1MG AB 2MG AB 3MG TEVA PHARMS AB 0.5MG AB 1MG AB 2MG AB 3MG VINTAGE AB 0.5MG AB 1MG AB 2MG AB 3MG WATSON LABS FLORIDA AB 0.5MG AB 1MG AB 2MG AB 3MG ZYDUS PHARMS USA INC 0.5MG AB AB 1MG AB 2MG AB 3MG XANAX XR PHARMACIA AND UPJOHN 0.5MG AB AB 1MG AB 2MG

3 - 17 (of 424)

A078056 A078056 A078387 A078387 A078387 A078387 A078469 A078469 A078469 A078469 A078449 A078449 A078449 A090871 A090871 A090871 A090871 A077725 A077725 A077725 A077725 A077996 A077996 A077996 A077996 A077968 A077968 A077968 A077968 A077391 A077391 A077391 A077391 A077777 A077777 A077777 A077777 A077979 A077979 A077979 A077979 A078442 A078442 A078442 A078442 A077198 A077198 A077198 A077198 A078489 A078489 A078489 A078489

003 004 001 002 003 004 001 002 003 004 001 002 003 001 002 003 004 001 002 004 003 001 002 003 004 004 003 002 001 002 003 004 001 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004

Feb Feb May May May May Sep Sep Sep Sep Nov Nov Nov Jun Jun Jun Jun Jul Jul Jul Jul Jan Jan Jan Jan May May May May Jan Jan Jan Jan Jun Jun Jun Jun Feb Feb Feb Feb Oct Oct Oct Oct May May May May Oct Oct Oct Oct

13, 13, 30, 30, 30, 30, 29, 29, 29, 29, 12, 12, 12, 07, 07, 07, 07, 31, 31, 31, 31, 31, 31, 31, 31, 24, 24, 24, 24, 26, 26, 26, 26, 30, 30, 30, 30, 28, 28, 28, 28, 15, 15, 15, 15, 13, 13, 13, 13, 17, 17, 17, 17,

2007 2007 2008 2008 2008 2008 2011 2011 2011 2011 2008 2008 2008 2011 2011 2011 2011 2006 2006 2006 2006 2007 2007 2007 2007 2007 2007 2007 2007 2006 2006 2006 2006 2006 2006 2006 2006 2007 2007 2007 2007 2007 2007 2007 2007 2010 2010 2010 2010 2008 2008 2008 2008

N021434 001 N021434 002 N021434 003

Jan 17, 2003 Jan 17, 2003 Jan 17, 2003

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

ALPRAZOLAM
TABLET, EXTENDED RELEASE; ORAL XANAX XR AB + PHARMACIA AND UPJOHN 3MG TABLET, ORALLY DISINTEGRATING; ORAL ALPRAZOLAM ACTAVIS ELIZABETH 0.25MG 0.5MG 1MG 2MG PAR PHARM 0.25MG 0.5MG 1MG 2MG NIRAVAM SCHWARZ PHARMA 0.25MG 0.5MG + 1MG 2MG

3 - 18 (of 424)

N021434 004

Jan 17, 2003

AB AB AB AB AB AB AB AB AB AB AB AB

A078561 A078561 A078561 A078561 A078088 A078088 A078088 A078088 N021726 N021726 N021726 N021726

001 002 003 004 001 002 003 004 001 002 003 004

Mar Mar Mar Mar Jan Jan Jan Jan Jan Jan Jan Jan

16, 16, 16, 16, 09, 09, 09, 09, 19, 19, 19, 19,

2010 2010 2010 2010 2009 2009 2009 2009 2005 2005 2005 2005

ALPROSTADIL
INJECTABLE; INJECTION ALPROSTADIL BEDFORD TEVA PARENTERAL CAVERJECT PHARMACIA AND UPJOHN + + EDEX SCHWARZ PHARMA + PROSTIN VR PEDIATRIC + PHARMACIA AND UPJOHN CAVERJECT PHARMACIA AND UPJOHN CAVERJECT IMPULSE PHARMACIA AND UPJOHN EDEX + SCHWARZ PHARMA + +

AP AP AP AP AP AP AP AP AP XX XX XX XX XX XX

0.5MG/ML 0.5MG/ML 0.01MG/VIAL 0.02MG/VIAL 0.04MG/VIAL 0.01MG/VIAL 0.02MG/VIAL 0.04MG/VIAL 0.5MG/ML 0.005MG/VIAL 0.01MG/VIAL 0.02MG/VIAL 0.01MG/VIAL 0.02MG/VIAL 0.04MG/VIAL

A074815 001 A075196 001 N020379 001 N020379 002 N020379 004 N020649 002 N020649 003 N020649 004 N018484 001 N020379 003 N021212 001 N021212 002 N020649 005 N020649 006 N020649 007

Jan 20, 1998 Apr 30, 1999 Jul 06, 1995 Jul 06, 1995 May 19, 1997 Jun 12, 1997 Jun 12, 1997 Jun 12, 1997

Jun 27, 1996 Jun 11, 2002 Jun 11, 2002 Jul 30, 1998 Jul 30, 1998 Jul 30, 1998

SUPPOSITORY; URETHRAL MUSE MEDA PHARMS XX XX XX XX +

0.125MG 0.25MG 0.5MG 1MG

N020700 N020700 N020700 N020700

001 002 003 004

Nov Nov Nov Nov

19, 19, 19, 19,

1996 1996 1996 1996

ALTRETAMINE
CAPSULE; ORAL

HEXALEN

XX + EISAI INC

50MG

N019926 001

Dec 26, 1990

ALVIMOPAN
CAPSULE; ORAL

ENTEREG

XX + ADOLOR

12MG

N021775 001

May 20, 2008

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

AMANTADINE HYDROCHLORIDE
CAPSULE; ORAL AMANTADINE HYDROCHLORIDE BANNER PHARMACAPS AB 100MG SANDOZ AB 100MG AB + USL PHARMA 100MG SYRUP; ORAL AMANTADINE HYDROCHLORIDE + CAROLINA MEDCL 50MG/5ML + HI TECH PHARMA 50MG/5ML + MIKART 50MG/5ML + PHARM ASSOC 50MG/5ML + SILARX 50MG/5ML + VINTAGE 50MG/5ML + WOCKHARDT 50MG/5ML

3 - 19 (of 424)

A078720 001 A071293 001 A070589 001

May 29, 2008 Feb 18, 1987 Aug 05, 1986

AA AA AA AA AA AA AA

A075819 A074170 A074028 A074509 A076352 A077992 A075060

001 001 001 001 001 001 001

Sep Oct Jun Jul Sep Dec Dec

11, 28, 28, 17, 10, 12, 24,

2002 1994 1993 1995 2004 2006 1998

TABLET; ORAL
AMANTADINE HYDROCHLORIDE
100MG XX + USL PHARMA

A076186 001

Dec 16, 2002

AMBENONIUM CHLORIDE
TABLET; ORAL
MYTELASE
XX + SANOFI AVENTIS US

10MG

N010155 002

AMBRISENTAN
TABLET; ORAL LETAIRIS GILEAD XX XX +

5MG 10MG

N022081 001 N022081 002

Jun 15, 2007 Jun 15, 2007

AMCINONIDE
CREAM; TOPICAL AMCINONIDE AB + ALTANA TARO PHARM INDS AB LOTION; TOPICAL
AMCINONIDE
XX + ALTANA OINTMENT; TOPICAL AMCINONIDE AB + ALTANA TARO PHARM INDS AB

0.1% 0.1%

A076065 001 A076229 001

May 15, 2003 May 31, 2002

0.1%

A076329 001

Nov 06, 2002

0.1% 0.1%

A076096 001 A076367 001

Nov 19, 2002 Mar 19, 2003

AMIFOSTINE
INJECTABLE; INJECTION AMIFOSTINE SUN PHARMA GLOBAL AP ETHYOL AP + MEDIMMUNE

500MG/VIAL 500MG/VIAL

A077126 001 N020221 001

Mar 14, 2008 Dec 08, 1995

AMIKACIN SULFATE
INJECTABLE; INJECTION AMIKACIN SULFATE AP + BEDFORD AP + HOSPIRA AP AP TEVA PARENTERAL AP

EQ EQ EQ EQ EQ

50MG BASE/ML 250MG BASE/ML 50MG BASE/ML 250MG BASE/ML 250MG BASE/ML

A063313 A063315 A063263 A063264 A064045

001 001 001 001 002

Apr Apr Nov Nov Sep

11, 11, 30, 30, 28,

1994 1994 1994 1994 1993

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

AMILORIDE HYDROCHLORIDE
TABLET; ORAL AMILORIDE HYDROCHLORIDE AB + PAR PHARM 5MG SIGMAPHARM LABS LLC AB 5MG MIDAMOR PADDOCK LLC AB 5MG

3 - 20 (of 424)

A070346 001 A079133 001 N018200 001

Jan 22, 1986 Jan 30, 2009

AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

TABLET; ORAL AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE BARR AB EQ 5MG ANHYDROUS;50MG AB + MYLAN EQ 5MG ANHYDROUS;50MG

A071111 001
A073209 001

May 10, 1988

Oct 31, 1991

AMINO ACIDS
INJECTABLE; INJECTION AMINOSYN 10% HOSPIRA 10% (10GM/100ML) AMINOSYN 10% (PH6) HOSPIRA 10% (10GM/100ML) AMINOSYN 3.5% HOSPIRA 3.5% (3.5GM/100ML) AMINOSYN 5% HOSPIRA 5% (5GM/100ML) AMINOSYN 7% HOSPIRA 7% (7GM/100ML) AMINOSYN 7% (PH6) HOSPIRA 7% (7GM/100ML) AMINOSYN 8.5% HOSPIRA 8.5% (8.5GM/100ML) AMINOSYN 8.5% (PH6) HOSPIRA 8.5% (8.5GM/100ML) AMINOSYN II 10% HOSPIRA 10% (10GM/100ML) AMINOSYN II 10% IN PLASTIC CONTAINER HOSPIRA 10% (10GM/100ML) AMINOSYN II 15% IN PLASTIC CONTAINER HOSPIRA 15% (15GM/100ML) AMINOSYN II 7% HOSPIRA 7% (7GM/100ML) AMINOSYN II 8.5% HOSPIRA 8.5% (8.5GM/100ML) AMINOSYN-HBC 7% HOSPIRA 7% (7GM/100ML) AMINOSYN-HF 8% HOSPIRA 8% (8GM/100ML) AMINOSYN-PF 10% HOSPIRA 10% (10GM/100ML) AMINOSYN-PF 7% HOSPIRA 7% (7GM/100ML) AMINOSYN-RF 5.2% HOSPIRA 5.2% (5.2GM/100ML) BRANCHAMIN 4% IN PLASTIC CONTAINER BAXTER HLTHCARE 4% (4GM/100ML) CLINISOL 15% SULFITE FREE IN PLASTIC CONTAINER CLINTEC NUTR 15% (15GM/100ML) FREAMINE HBC 6.9% B BRAUN 6.9% (6.9GM/100ML) FREAMINE III 10% B BRAUN 10% (10GM/100ML)

XX XX XX XX XX XX XX XX XX XX XX XX XX XX XX XX XX XX XX XX XX XX

N017673 003 N017673 008 N017789 004 N017673 001 N017673 002 N017673 006 N017673 004 N017673 007 N019438 005 N020015 001 N020041 001 N019438 003 N019438 004 N019374 001 N020345 001 N019492 002 N019398 001 N018429 001 N018684 001 A020512 001 N016822 006 N016822 005 Sep 28, 1984 Aug 30, 1996 May 17, 1983 Nov 18, 1985 Apr 03, 1986 Dec 19, 1991 Dec 19, 1991 Apr 03, 1986 Apr 03, 1986 Jul 12, 1985 Apr 04, 1996 Oct 17, 1986 Sep 06, 1985 Nov 18, 1985 Nov 18, 1985

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

AMINO ACIDS
INJECTABLE; INJECTION FREAMINE III 8.5% B BRAUN 8.5% (8.5GM/100ML) HEPATAMINE 8% B BRAUN 8% (8GM/100ML) HEPATASOL 8% BAXTER HLTHCARE 8% (8GM/100ML) NEPHRAMINE 5.4% B BRAUN 5.4% (5.4GM/100ML) PREMASOL 10% IN PLASTIC CONTAINER BAXTER HLTHCARE 10% (10GM/100ML) PREMASOL 6% IN PLASTIC CONTAINER BAXTER HLTHCARE 6% (6GM/100ML) PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER + BAXTER HLTHCARE 20% (20GM/100ML) RENAMIN W/O ELECTROLYTES BAXTER HLTHCARE 6.5% (6.5GM/100ML) TRAVASOL 10% IN PLASTIC CONTAINER BAXTER HLTHCARE 10% (10MG/100ML) TRAVASOL 10% W/O ELECTROLYTES BAXTER HLTHCARE 10% (10GM/100ML) TRAVASOL 5.5% IN PLASTIC CONTAINER BAXTER HLTHCARE 5.5% (5.5GM/100ML) TRAVASOL 5.5% W/O ELECTROLYTES BAXTER HLTHCARE 5.5% (5.5GM/100ML) TRAVASOL 8.5% IN PLASTIC CONTAINER BAXTER HLTHCARE 8.5% (8.5GM/100ML) TRAVASOL 8.5% W/O ELECTROLYTES BAXTER HLTHCARE 8.5% (8.5GM/100ML)

TROPHAMINE
+ B BRAUN 6% (6GM/100ML) TROPHAMINE 10% + B BRAUN 10% (10GM/100ML)

3 - 21 (of 424)

XX XX XX XX XX XX XX XX XX XX XX XX XX XX XX XX

N016822 004 N018676 001 A020360 001 N017766 001 A075880 002 A075880 001 N020849 001 N017493 007 N018931 003 N017493 006 N018931 001 N017493 004 N018931 002 N017493 005
N019018 001 N019018 003 Jul 20, 1984 Sep 07, 1988 Aug 23, 1984 Aug 23, 1984 Jun 19, 2003 Jun 19, 2003 Aug 26, 1998 Oct 15, 1982 Aug 23, 1984 Aug 03, 1982 Apr 04, 1996

AMINO ACIDS; CALCIUM ACETATE; GLYCERIN; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE

INJECTABLE; INJECTION

PROCALAMINE
B BRAUN XX

3%;26MG/100ML;3GM/100ML;54MG/100ML;41MG /100ML;150MG/100ML;200MG/100ML;120MG/10 0ML

N018582 001

May 08, 1982

AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE
INJECTABLE; INJECTION CLINIMIX E 2.75/10 SULFITE-FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER + BAXTER HLTHCARE 2.75%;33MG/100ML;10GM/100ML;51MG/100ML; N020678 002 Mar 26, 1997 261MG/100ML;217MG/100ML;112MG/100ML CLINIMIX E 2.75/25 SULFITE-FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER + BAXTER HLTHCARE 2.75%;33MG/100ML;25GM/100ML;51MG/100ML; N020678 005 Mar 26, 1997 261MG/100ML;217MG/100ML;112MG/100ML CLINIMIX E 2.75/5 SULFITE-FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER + BAXTER HLTHCARE 2.75%;33MG/100ML;5GM/100ML;51MG/100ML;2 N020678 001 Mar 26, 1997 61MG/100ML;217MG/100ML;112MG/100ML CLINIMIX E 4.25/10 SULFITE-FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER + BAXTER HLTHCARE 4.25%;33MG/100ML;10GM/100ML;51MG/100ML; N020678 009 Mar 26, 1997 261MG/100ML;297MG/100ML;77MG/100ML CLINIMIX E 4.25/20 SULFITE-FREE W/ ELECT IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER + BAXTER HLTHCARE 4.25%;33MG/100ML;20GM/100ML;51MG/100ML; N020678 011 Mar 26, 1997 261MG/100ML;297MG/100ML;77MG/100ML

XX

XX

XX

XX

XX

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 22 (of 424)

AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE
INJECTABLE; INJECTION CLINIMIX E 4.25/25 SULFITE-FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER + BAXTER HLTHCARE 4.25%;33MG/100ML;25GM/100ML;51MG/100ML; N020678 012 Mar 26, 1997 261MG/100ML;297MG/100ML;77MG/100ML CLINIMIX E 4.25/5 SULFITE-FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER + BAXTER HLTHCARE 4.25%;33MG/100ML;5GM/100ML;51MG/100ML;2 N020678 008 Mar 26, 1997 61MG/100ML;297MG/100ML;77MG/100ML CLINIMIX E 5/10 SULFITE-FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER + BAXTER HLTHCARE 5%;33MG/100ML;10GM/100ML;51MG/100ML;261 N020678 016 Mar 26, 1997 MG/100ML;340MG/100ML;59MG/100ML CLINIMIX E 5/15 SULFITE-FREE W/ ELECT IN DEXTROSE 15% W/ CALCIUM IN PLASTIC CONTAINER + BAXTER HLTHCARE 5%;33MG/100ML;15GM/100ML;51MG/100ML;261 N020678 017 Mar 26, 1997 MG/100ML;340MG/100ML;59MG/100ML CLINIMIX E 5/20 SULFITE-FREE W/ ELECT IN 20% DEXTROSE W/ CALCIUM IN PLASTIC CONTAINER + BAXTER HLTHCARE 5%;33MG/100ML;20GM/100ML;51MG/100ML;261 N020678 018 Mar 26, 1997 MG/100ML;340MG/100ML;59MG/100ML CLINIMIX E 5/25 SULFITE-FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER + BAXTER HLTHCARE 5%;33MG/100ML;25GM/100ML;51MG/100ML;261 N020678 019 Mar 26, 1997 MG/100ML;340MG/100ML;59MG/100ML CLINIMIX E 5/35 SULFITE-FREE W/ ELECT IN DEXTROSE 35% W/ CALCIUM IN PLASTIC CONTAINER + BAXTER HLTHCARE 5%;33MG/100ML;35GM/100ML;51MG/100ML;261 N020678 021 Mar 26, 1997 MG/100ML;340MG/100ML;59MG/100ML

XX

XX

XX

XX

XX

XX

XX

AMINO ACIDS; DEXTROSE

INJECTABLE; INJECTION CLINIMIX 2.75/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER BAXTER HLTHCARE 2.75%;10GM/100ML N020734 CLINIMIX 2.75/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER BAXTER HLTHCARE 2.75%;25GM/100ML N020734 CLINIMIX 2.75/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER BAXTER HLTHCARE 2.75%;5GM/100ML N020734 CLINIMIX 4.25/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER BAXTER HLTHCARE 4.25%;10GM/100ML N020734 CLINIMIX 4.25/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER BAXTER HLTHCARE 4.25%;20GM/100ML N020734 CLINIMIX 4.25/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER N020734 BAXTER HLTHCARE 4.25%;25GM/100ML CLINIMIX 4.25/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER N020734 BAXTER HLTHCARE 4.25%;5GM/100ML CLINIMIX 5/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER N020734 BAXTER HLTHCARE 5%;10GM/100ML CLINIMIX 5/15 SULFITE FREE IN DEXTROSE 15% IN PLASTIC CONTAINER N020734 BAXTER HLTHCARE 5%;15GM/100ML CLINIMIX 5/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER N020734 BAXTER HLTHCARE 5%;20GM/100ML CLINIMIX 5/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER BAXTER HLTHCARE 5%;25GM/100ML N020734 CLINIMIX 5/35 SULFITE FREE IN DEXTROSE 35% IN PLASTIC CONTAINER BAXTER HLTHCARE 5%;35GM/100ML N020734

XX XX XX XX XX XX XX XX XX XX XX XX

002 005 001 008 010 011 007 014 015 016 017 018

Sep 29, 1997 Sep 29, 1997 Sep 29, 1997 Sep 29, 1997 Sep 29, 1997 Sep 29, 1997 Sep 29, 1997 Sep 29, 1997 Sep 29, 1997 Sep 29, 1997 Sep 29, 1997 Sep 29, 1997

AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM ACETATE; POTASSIUM CHLORIDE; SODIUM ACETATE
INJECTABLE; INJECTION FREAMINE III 8.5% W/ ELECTROLYTES B BRAUN 8.5%;110MG/100ML;230MG/100ML;10MG/100ML XX ;440MG/100ML;690MG/100ML

N016822 007

Jul 01, 1988

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 23 (of 424)

AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM ACETATE; SODIUM CHLORIDE
INJECTABLE; INJECTION

AMINOSYN 3.5% M

HOSPIRA XX

3.5%;21MG/100ML;40MG/100ML;128MG/100ML; 234MG/100ML

N017789 003

AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE
INJECTABLE; INJECTION

FREAMINE III 3% W/ ELECTROLYTES

B BRAUN 3%;54MG/100ML;40MG/100ML;150MG/100ML;20 XX 0MG/100ML;120MG/100ML

N016822 003

AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE
INJECTABLE; INJECTION AMINOSYN II 10% W/ ELECTROLYTES HOSPIRA 10%;102MG/100ML;45MG/100ML;522MG/100ML; XX 410MG/100ML AMINOSYN II 8.5% W/ ELECTROLYTES HOSPIRA 8.5%;102MG/100ML;45MG/100ML;522MG/100ML XX ;410MG/100ML

N019437 004

Apr 03, 1986

N019437 005

Apr 03, 1986

AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE
INJECTABLE; INJECTION TRAVASOL 3.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER BAXTER HLTHCARE 3.5%;51MG/100ML;131MG/100ML;218MG/100ML XX ;35MG/100ML TRAVASOL 3.5% W/ ELECTROLYTES BAXTER HLTHCARE 3.5%;51MG/100ML;131MG/100ML;218MG/100ML XX ;35MG/100ML TRAVASOL 5.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER BAXTER HLTHCARE 5.5%;102MG/100ML;522MG/100ML;431MG/100M XX L;224MG/100ML TRAVASOL 5.5% W/ ELECTROLYTES BAXTER HLTHCARE 5.5%;102MG/100ML;522MG/100ML;431MG/100M XX L;224MG/100ML TRAVASOL 8.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER XX BAXTER HLTHCARE 8.5%;102MG/100ML;522MG/100ML;594MG/100M L;154MG/100ML TRAVASOL 8.5% W/ ELECTROLYTES XX BAXTER HLTHCARE 8.5%;102MG/100ML;522MG/100ML;594MG/100M L;154MG/100ML

N020177 001

Oct 23, 1995

N017493 003

N020173 001

Oct 27, 1995

N017493 001

N020173 002

Oct 27, 1995

N017493 002

AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE

INJECTABLE; INJECTION
AMINOSYN 7% W/ ELECTROLYTES
HOSPIRA 7%;102MG/100ML;522MG/100ML;410MG/100ML XX AMINOSYN 8.5% W/ ELECTROLYTES
HOSPIRA 8.5%;102MG/100ML;522MG/100ML;410MG/100M XX L

N017789 002
N017673 005

AMINOCAPROIC ACID
INJECTABLE; INJECTION AMINOCAPROIC ACID LUITPOLD AP 250MG/ML AMINOCAPROIC ACID IN PLASTIC CONTAINER AP + HOSPIRA 250MG/ML SYRUP; ORAL AMICAR AA + XANODYNE PHARM

A071192 001 A070010 001

Dec 01, 1987 Mar 09, 1987

1.25GM/5ML

N015230 002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

AMINOCAPROIC ACID
SYRUP; ORAL AMINOCAPROIC ACID MIKART AA TABLET; ORAL AMICAR XANODYNE PHARM AB AMINOCAPROIC MIKART AB AMICAR XX + XANODYNE PHARM

3 - 24 (of 424)

1.25GM/5ML

A074759 001

Sep 02, 1998

500MG 500MG 1GM

N015197 001 A075602 001 N015197 002 May 24, 2001 Jun 24, 2004

AMINOHIPPURATE SODIUM

INJECTABLE; INJECTION

AMINOHIPPURATE SODIUM
XX + MERCK

20%

N005619 001

AMINOLEVULINIC ACID HYDROCHLORIDE

SOLUTION; TOPICAL

LEVULAN
XX + DUSA

20%

N020965 001

Dec 03, 1999

AMINOPHYLLINE
INJECTABLE; INJECTION AMINOPHYLLINE + HOSPIRA INTL MEDICATION LUITPOLD PHARMA SERVE NY

AP AP AP AP

25MG/ML 25MG/ML 25MG/ML 25MG/ML

A087242 A087209 A087600 A087392

001 001 001 001

Oct 26, 1983 Feb 01, 1982 Dec 15, 1983

TABLET; ORAL

AMINOPHYLLINE
XX + WEST WARD XX +

100MG 200MG

A084540 001 A085003 001

AMINOSALICYLIC ACID
GRANULE, DELAYED RELEASE; ORAL

PASER

4GM/PACKET XX + JACOBUS

A074346 001

Jun 30, 1994

AMIODARONE HYDROCHLORIDE
INJECTABLE; INJECTION AMIODARONE HYDROCHLORIDE + AKORN 50MG/ML + APP PHARMS 50MG/ML + BEDFORD 50MG/ML + BEDFORD LABS 50MG/ML + BIONICHE PHARMA 50MG/ML + CLARIS LIFESCIENCES 50MG/ML + GLAND PHARMA LTD 50MG/ML HIKMA FARMACEUTICA 50MG/ML + HOSPIRA 50MG/ML + TEVA PARENTERAL 50MG/ML WOCKHARDT 50MG/ML 50MG/ML NEXTERONE BAXTER HLTHCARE 50MG/ML NEXTERONE + BAXTER HLTHCARE 150MG/100ML (1.5MG/ML) + 360MG/200ML (1.8MG/ML)

AP AP AP AP AP AP AP AP AP AP AP AP AP XX XX

A076232 A075761 A076018 A076299 A076217 A076394 A077161 A077234 A075955 A076163 A077610 A077834

001 001 001 001 001 001 001 001 001 001 001 001

Jul Oct Oct Oct Oct Apr Apr Feb Oct Sep Oct Oct

05, 15, 15, 24, 15, 25, 20, 25, 18, 05, 30, 30,

2006 2002 2002 2002 2002 2003 2005 2008 2002 2003 2008 2008

N022325 001 N022325 002 N022325 003

Dec 24, 2008 Nov 16, 2010 Nov 16, 2010

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

AMIODARONE HYDROCHLORIDE
TABLET; ORAL AMIODARONE HYDROCHLORIDE APOTEX CORP 200MG AUROSAL PHARMS 200MG 400MG BARR 200MG MYLAN 200MG SANDOZ 200MG 400MG TARO 100MG 200MG 400MG TEVA PHARMS 200MG ZYDUS PHARMS USA INC 200MG CORDARONE + WYETH PHARMS INC 200MG PACERONE UPSHER SMITH 100MG 200MG AMIODARONE HYDROCHLORIDE TARO 300MG

3 - 25 (of 424)

AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB XX

A078578 A077069 A077069 A075389 A075188 A075315 A075315 A075424 A075424 A076362 A074739 A079029

001 001 002 001 001 001 002 002 001 001 001 001

Nov Apr Apr Jan Feb Dec Jun Dec Mar Nov Nov Sep

06, 08, 08, 25, 24, 23, 30, 18, 30, 29, 30, 16,

2008 2005 2005 2001 1999 1998 2000 2002 2001 2002 1998 2008

N018972 001 A075135 002 A075135 001 A076362 002

Dec 24, 1985 Apr 12, 2005 Apr 30, 1998 Dec 02, 2003

AMITRIPTYLINE HYDROCHLORIDE
TABLET; ORAL AMITRIPTYLINE HYDROCHLORIDE CARACO AB 10MG AB 25MG AB 50MG AB 75MG AB 100MG AB 150MG MUTUAL PHARM AB 10MG AB 25MG AB 50MG AB 75MG AB 100MG AB 150MG MYLAN AB 10MG AB 25MG AB 50MG AB 75MG AB 100MG AB 150MG SANDOZ AB 10MG AB + 25MG AB 50MG AB 75MG AB 100MG AB 150MG VINTAGE PHARMS AB 10MG AB 25MG AB 50MG AB 75MG AB 100MG AB 150MG

A040815 A040816 A040817 A040818 A040819 A040820 A089398 A089399 A089400 A089401 A089402 A089403 A086009 A086009 A086009 A086009 A086009 A086009 A085969 A085966 A085968 A085971 A085967 A085970 A040218 A040218 A040218 A040218 A040218 A040218

001 001 001 001 001 001 001 001 001 001 001 001 002 003 001 004 005 006 001 001 001 001 001 001 001 002 003 004 005 006

Jun Jun Jun Jun Jun Jun Jul Jul Jul Jul Jul Jul

27, 27, 27, 27, 27, 27, 14, 14, 14, 14, 14, 14,

2008 2008 2008 2008 2008 2008 1987 1987 1987 1987 1987 1987

Sep Sep Sep Sep Sep Sep

11, 11, 11, 11, 11, 11,

1997 1997 1997 1997 1997 1997

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE
TABLET; ORAL CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE MYLAN AB EQ 12.5MG BASE;5MG AB EQ 25MG BASE;10MG LIMBITROL VALEANT PHARM INTL AB EQ 12.5MG BASE;5MG LIMBITROL DS AB + VALEANT PHARM INTL EQ 25MG BASE;10MG

3 - 26 (of 424)

A071297 002 A071297 001 N016949 001 N016949 002

Dec 10, 1986 Dec 10, 1986

AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE

TABLET; ORAL PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE MYLAN 10MG;2MG XX 10MG;4MG XX 25MG;2MG XX + 25MG;4MG XX + 50MG;4MG XX +

A071443 A071443 A071443 A071443 A071443

002 003 004 005 001

Nov Nov Nov Nov Nov

10, 10, 10, 10, 10,

1988 1988 1988 1988 1988

AMLEXANOX
PASTE; DENTAL

APHTHASOL

XX + ULURU

5%

N020511 001

Dec 17, 1996

AMLODIPINE BESYLATE
TABLET; ORAL AMLODIPINE BESYLATE ALKEM AB AB AB AMNEAL PHARMS NY AB AB AB APOTEX AB AB AB AUROBINDO PHARMA AB AB AB CARACO AB AB AB DR REDDYS LABS LTD AB AB AB EPIC PHARMA LLC AB AB AB HIKMA PHARMS AB AB AB INVAGEN PHARMS AB AB AB LEK PHARMS DD AB AB AB LUPIN AB AB AB

EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ

2.5MG BASE 5MG BASE 10MG BASE 2.5MG BASE 5MG BASE 10MG BASE 2.5MG BASE 5MG BASE 10MG BASE 2.5MG BASE 5MG BASE 10MG BASE 2.5MG BASE 5MG BASE 10MG BASE 2.5MG BASE 5MG BASE 10MG BASE 2.5MG BASE 5MG BASE 10MG BASE 2.5MG BASE 5MG BASE 10MG BASE 2.5MG BASE 5MG BASE 10MG BASE 2.5MG BASE 5MG BASE 10MG BASE 2.5MG BASE 5MG BASE 10MG BASE

A078925 A078925 A078925 A078477 A078477 A078477 A076719 A076719 A076719 A078021 A078021 A078021 A078231 A078231 A078231 A076692 A076692 A076692 A078552 A078552 A078552 A077771 A077771 A077771 A077955 A077955 A077955 A076859 A076859 A076859 A078043 A078043 A078043

001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003

May May May Jan Jan Jan May May May Jul Jul Jul Nov Nov Nov Jul Jul Jul Apr Apr Apr Apr Apr Apr Aug Aug Aug Sep Sep Sep Jul Jul Jul

04, 04, 04, 16, 16, 16, 23, 23, 23, 17, 17, 17, 30, 30, 30, 20, 20, 20, 08, 08, 08, 12, 12, 12, 28, 28, 28, 10, 10, 10, 12, 12, 12,

2009 2009 2009 2008 2008 2008 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2009 2009 2009 2011 2011 2011 2007 2007 2007 2007 2007 2007 2007 2007 2007

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

AMLODIPINE BESYLATE
TABLET; ORAL AMLODIPINE BESYLATE MATRIX LABS LTD AB AB AB MYLAN AB AB AB ORCHID HLTHCARE AB AB AB PURACAP PHARM AB AB AB RANBAXY AB AB AB ROXANE AB AB AB SECAN PHARMS AB AB TEVA AB AB AB TORRENT PHARMS AB AB AB UPSHER SMITH AB AB AB VINTAGE AB AB AB WATSON LABS AB AB AB AB AB AB WOCKHARDT AB AB AB WORLD GEN AB AB AB ZYDUS PHARMS USA AB AB AB NORVASC PFIZER AB AB AB +

3 - 27 (of 424)

EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ

2.5MG BASE 5MG BASE 10MG BASE 2.5MG BASE 5MG BASE 10MG BASE 2.5MG BASE 5MG BASE 10MG BASE 2.5MG BASE 5MG BASE 10MG BASE 2.5MG BASE 5MG BASE 10MG BASE 2.5MG BASE 5MG BASE 10MG BASE 5MG BASE 10MG BASE 2.5MG BASE 5MG BASE 10MG BASE 2.5MG BASE 5MG BASE 10MG BASE 2.5MG BASE 5MG BASE 10MG BASE 2.5MG BASE 5MG BASE 10MG BASE 2.5MG BASE 2.5MG BASE 5MG BASE 5MG BASE 10MG BASE 10MG BASE 2.5MG BASE 5MG BASE 10MG BASE 2.5MG BASE 5MG BASE 10MG BASE 2.5MG BASE 5MG BASE 10MG BASE

A078224 A078224 A078224 A076418 A076418 A076418 A078453 A078453 A078453 A078131 A078131 A078131 A077974 A077974 A077974 A077262 A077262 A077262 A090752 A090752 A076846 A076846 A076846 A078573 A078573 A078573 A077759 A077759 A077759 A078414 A078414 A078414 A077073 A077671 A077073 A077671 A077073 A077671 A078500 A078500 A078500 A077516 A077516 A077516 A078226 A078226 A078226

001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 001 002 001 002 003 001 002 003 001 002 003 001 002 003 001 001 002 002 003 003 001 002 003 001 002 003 001 002 003

Feb Feb Feb Oct Oct Oct Jul Jul Jul Sep Sep Sep Jul Jul Jul Jul Jul Jul Apr Apr Jun Jun Jun Sep Sep Sep Jul Jul Jul Apr Apr Apr Sep Jul Sep Jul Sep Jul Sep Sep Sep Jul Jul Jul Jul Jul Jul

27, 27, 27, 03, 03, 03, 02, 02, 02, 04, 04, 04, 09, 09, 09, 09, 09, 09, 15, 15, 28, 28, 28, 22, 22, 22, 09, 09, 09, 07, 07, 07, 26, 19, 26, 19, 26, 19, 06, 06, 06, 11, 11, 11, 09, 09, 09,

2008 2008 2008 2005 2005 2005 2009 2009 2009 2007 2007 2007 2007 2007 2007 2007 2007 2007 2011 2011 2007 2007 2007 2008 2008 2008 2007 2007 2007 2010 2010 2010 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007

EQ 2.5MG BASE EQ 5MG BASE EQ 10MG BASE

N019787 001 N019787 002 N019787 003

Jul 31, 1992 Jul 31, 1992 Jul 31, 1992

AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM

TABLET; ORAL
CADUET
PFIZER XX XX

EQ 2.5MG BASE;EQ 10MG BASE EQ 2.5MG BASE;EQ 20MG BASE

N021540 009 N021540 010

Jul 29, 2004 Jul 29, 2004

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
TABLET; ORAL CADUET PFIZER XX XX XX XX XX XX XX XX XX +

3 - 28 (of 424)

EQ EQ EQ EQ EQ EQ EQ EQ EQ

2.5MG BASE;EQ 40MG BASE 5MG BASE;EQ 10MG BASE 5MG BASE;EQ 20MG BASE 5MG BASE;EQ 40MG BASE 5MG BASE;EQ 80MG BASE 10MG BASE;EQ 10MG BASE 10MG BASE;EQ 20MG BASE 10MG BASE;EQ 40MG BASE 10MG BASE;EQ 80MG BASE

N021540 N021540 N021540 N021540 N021540 N021540 N021540 N021540 N021540

011 001 002 003 004 005 006 007 008

Jul Jan Jan Jan Jan Jan Jan Jan Jan

29, 30, 30, 30, 30, 30, 30, 30, 30,

2004 2004 2004 2004 2004 2004 2004 2004 2004

AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE

CAPSULE; ORAL AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE DR REDDYS LABS INC AB EQ 2.5MG BASE;10MG AB EQ 5MG BASE;10MG AB EQ 5MG BASE;20MG AB EQ 5MG BASE;40MG AB EQ 10MG BASE;20MG AB EQ 10MG BASE;40MG LUPIN PHARMS AB EQ 2.5MG BASE;10MG AB EQ 5MG BASE;10MG AB EQ 5MG BASE;20MG AB EQ 5MG BASE;40MG AB EQ 10MG BASE;20MG AB EQ 10MG BASE;40MG MYLAN AB EQ 2.5MG BASE;10MG AB EQ 5MG BASE;10MG AB EQ 5MG BASE;20MG AB EQ 5MG BASE;40MG AB EQ 10MG BASE;20MG AB EQ 10MG BASE;40MG PAR PHARM AB EQ 2.5MG BASE;10MG AB EQ 5MG BASE;10MG AB EQ 5MG BASE;20MG AB EQ 5MG BASE;40MG AB EQ 10MG BASE;20MG AB EQ 10MG BASE;40MG TEVA PHARMS AB EQ 2.5MG BASE;10MG AB EQ 5MG BASE;10MG AB EQ 5MG BASE;20MG AB EQ 5MG BASE;40MG AB EQ 10MG BASE;20MG AB EQ 10MG BASE;40MG WATSON LABS AB EQ 2.5MG BASE;10MG AB EQ 5MG BASE;10MG AB EQ 5MG BASE;20MG AB EQ 10MG BASE;20MG WATSON LABS INC AB EQ 5MG BASE;40MG AB EQ 10MG BASE;40MG LOTREL NOVARTIS AB EQ 2.5MG BASE;10MG AB EQ 5MG BASE;10MG AB EQ 5MG BASE;20MG AB EQ 5MG BASE;40MG AB EQ 10MG BASE;20MG AB + EQ 10MG BASE;40MG

A077183 A077183 A077183 A090149 A077183 A090149 A078466 A078466 A078466 A078466 A078466 A078466 A077375 A077375 A077375 A079047 A077375 A079047 A078381 A078381 A078381 A078381 A078381 A078381 A077179 A077179 A077179 A077179 A077179 A077179 A077890 A077890 A077890 A077890 A090364 A090364 N020364 N020364 N020364 N020364 N020364 N020364

001 002 003 001 004 002 001 002 003 005 004 006 001 002 003 001 004 002 001 002 003 005 004 006 001 002 003 005 004 006 001 002 003 004 001 002 002 003 004 007 005 006

Apr Apr Apr Jul Apr Jul Feb Feb Feb Jul Feb Jul May May May Jul May Jul Jul Jul Jul Jul Jul Jul May May May Jul May Jul Oct Oct Oct Oct Jul Jul Mar Mar Mar Apr Jun Apr

15, 15, 15, 05, 15, 05, 05, 05, 05, 05, 05, 05, 21, 21, 21, 05, 21, 05, 29, 29, 29, 29, 29, 29, 18, 18, 18, 05, 18, 05, 14, 14, 14, 14, 05, 05, 03, 03, 03, 11, 20, 11,

2010 2010 2010 2011 2010 2011 2010 2010 2010 2011 2010 2011 2010 2010 2010 2011 2010 2011 2010 2010 2010 2010 2010 2010 2007 2007 2007 2011 2007 2011 2010 2010 2010 2010 2011 2011 1995 1995 1995 2006 2002 2006

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
TABLET; ORAL
TRIBENZOR
DAIICHI SANKYO XX XX XX XX XX +

3 - 29 (of 424)

EQ EQ EQ EQ EQ

5MG BASE;12.5MG;20MG
5MG BASE;12.5MG;40MG
5MG BASE;25MG;40MG
10MG BASE;12.5MG;40MG
10MG BASE;25MG;40MG

N200175 N200175 N200175 N200175 N200175

001 002 003 004 005

Jul Jul Jul Jul Jul

23, 23, 23, 23, 23,

2010 2010 2010 2010 2010

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN

TABLET; ORAL
EXFORGE HCT
NOVARTIS XX XX XX XX XX +

5MG;12.5MG;160MG
5MG;25MG;160MG
10MG;12.5MG;160MG
10MG;25MG;160MG
10MG;25MG;320MG

N022314 N022314 N022314 N022314 N022314

001 002 003 004 005

Apr Apr Apr Apr Apr

30, 30, 30, 30, 30,

2009 2009 2009 2009 2009

AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL

TABLET; ORAL
AZOR
DAIICHI SANKYO XX XX XX XX +

EQ EQ EQ EQ

5MG BASE;20MG
5MG BASE;40MG
10MG BASE;20MG
10MG BASE;40MG

N022100 N022100 N022100 N022100

001 002 003 004

Sep Sep Sep Sep

26, 26, 26, 26,

2007 2007 2007 2007

AMLODIPINE BESYLATE; TELMISARTAN

TABLET; ORAL
TWYNSTA
BOEHRINGER INGELHEIM XX XX XX XX +

EQ EQ EQ EQ

5MG BASE;40MG
5MG BASE;80MG
10MG BASE;40MG
10MG BASE;80MG

N022401 N022401 N022401 N022401

001 003 002 004

Oct Oct Oct Oct

16, 16, 16, 16,

2009 2009 2009 2009

AMLODIPINE BESYLATE; VALSARTAN

TABLET; ORAL
EXFORGE
NOVARTIS
XX XX XX + XX +

EQ EQ EQ EQ

5MG BASE;160MG 5MG BASE;320MG 10MG BASE;160MG 10MG BASE;320MG

N021990 N021990 N021990 N021990

002 004 003 005

Jun Jun Jun Jun

20, 20, 20, 20,

2007 2007 2007 2007

AMMONIA, N-13

INJECTABLE; INTRAVENOUS
AMMONIA N 13
XX + FEINSTEIN

30MCI-300MCI/8ML (3.75-37.5MCI/ML)

N022119 001

Aug 23, 2007

AMMONIUM CHLORIDE
INJECTABLE; INJECTION
AMMONIUM CHLORIDE IN PLASTIC CONTAINER
5MEQ/ML XX + HOSPIRA

A088366 001

Jun 13, 1984

AMMONIUM LACTATE
CREAM; TOPICAL AMMONIUM LACTATE PADDOCK LLC AB PERRIGO NEW YORK AB TARO AB

EQ 12% BASE EQ 12% BASE EQ 12% BASE

A076829 001 A075774 001 A075883 001

Feb 07, 2006 May 01, 2002 Apr 10, 2003

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

AMMONIUM LACTATE
CREAM; TOPICAL LAC-HYDRIN AB + RANBAXY LOTION; TOPICAL AMMONIUM LACTATE PADDOCK LLC PERRIGO NEW YORK TARO LAC-HYDRIN + RANBAXY

3 - 30 (of 424)

EQ 12% BASE

N020508 001

Aug 29, 1996

AB AB AB AB

EQ 12% BASE EQ 12% BASE EQ 12% BASE EQ 12% BASE

A075575 001 A075570 001 A076216 001 N019155 001

Jun 11, 2002 Jun 23, 2004 May 28, 2004 Apr 24, 1985

AMOXAPINE
TABLET; ORAL AMOXAPINE WATSON LABS XX XX XX XX +

25MG 50MG 100MG 150MG

A072688 A072689 A072690 A072691

001 001 001 001

Aug Aug Aug Aug

28, 28, 28, 28,

1992 1992 1992 1992

AMOXICILLIN
CAPSULE; ORAL AMOXICILLIN AM ANTIBIOTICS AB AB AUROBINDO AB AB DAVA PHARMS INC AB AB HIKMA PHARMS AB AB RANBAXY AB AB SANDOZ AB AB TEVA AB AB + AMOXIL DR REDDYS LABS INC AB AB FOR SUSPENSION; ORAL AMOXICILLIN AUROBINDO AB AB DAVA PHARMS INC AB AB HIKMA AB AB AB AB RANBAXY AB AB SANDOZ AB AB AB AB TEVA AB AB AB + AB +

250MG 500MG 250MG 500MG 250MG 500MG 250MG 500MG 250MG 500MG 250MG 500MG 250MG 500MG 250MG 500MG

A062058 A062058 A065271 A065271 A062884 A062881 A065291 A065291 A065016 A065016 A064076 A064076 A061926 A061926

001 002 001 002 001 001 001 002 001 002 001 002 001 003

Nov Nov Feb Feb Feb Feb Apr Apr Sep Sep

09, 09, 25, 25, 05, 05, 08, 08, 30, 30,

2005 2005 1988 1988 2007 2007 1999 1999 1994 1994

A062216 001 A062216 004

200MG/5ML 400MG/5ML 125MG/5ML 250MG/5ML 125MG/5ML 200MG/5ML 250MG/5ML 400MG/5ML 200MG/5ML 400MG/5ML 125MG/5ML 200MG/5ML 250MG/5ML 400MG/5ML 125MG/5ML 200MG/5ML 250MG/5ML 400MG/5ML

A065334 A065334 A062927 A062927 A065322 A065325 A065322 A065325 A065113 A065113 A065387 A065378 A065387 A065378 A061931 A065119 A061931 A065119

001 002 001 002 002 002 001 001 001 002 001 001 002 002 001 001 002 002

Dec Dec Nov Nov Jun Jun Jun Jun Nov Nov Mar Mar Mar Mar

28, 28, 25, 25, 19, 19, 19, 19, 29, 29, 26, 26, 26, 26,

2006 2006 1988 1988 2006 2006 2006 2006 2002 2002 2007 2007 2007 2007

Dec 04, 2002 Dec 04, 2002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

AMOXICILLIN
FOR SUSPENSION; ORAL AMOXICILLIN WOCKHARDT AB AMOXICILLIN PEDIATRIC TEVA AB AMOXIL DR REDDYS LABS INC AB AB AB AB AB LAROTID DR REDDYS LABS INC AB AB TABLET; ORAL AMOXICILLIN AUROBINDO AB AB DAVA PHARMS INC AB HIKMA AB RANBAXY AB AB SANDOZ AB AB TEVA AB AB + AMOXIL DR REDDYS LABS INC AB AB TABLET, CHEWABLE; ORAL AMOXICILLIN DAVA PHARMS INC AB AB RANBAXY AB AB TEVA AB AB + AMOXIL DR REDDYS LABS INC AB AB AB AB AMOXICILLIN RANBAXY XX XX

3 - 31 (of 424)

400MG/5ML 50MG/ML 50MG/ML 125MG/5ML 200MG/5ML 250MG/5ML 400MG/5ML 125MG/5ML 250MG/5ML

A065319 002 A061931 003 A062226 A062226 N050760 A062226 N050760 005 001 001 002 002

Jun 18, 2007 Dec 01, 1982

Apr 15, 1999 Apr 15, 1999

A062226 003 A062226 004

500MG 875MG 875MG 875MG 500MG 875MG 500MG 875MG 500MG 875MG 500MG 875MG

A065256 A065256 A065344 A065255 A065059 A065059 A065228 A065228 A065056 A065056

001 002 001 001 001 002 001 002 001 002

Nov Nov Jan Mar Nov Nov Jul Jul Sep Sep

09, 09, 15, 29, 24, 24, 13, 13, 18, 18,

2005 2005 2009 2006 2000 2000 2005 2005 2000 2000

N050754 002 N050754 001

Jul 10, 1998 Jul 10, 1998

125MG 250MG 125MG 250MG 125MG 250MG 125MG 200MG 250MG 400MG 200MG 400MG

A064139 A064139 A065021 A065021 A064013 A064013 N050542 N050761 N050542 N050761

001 002 001 002 002 001 002 001 001 002

Jan Jan Dec Dec Sep Dec

29, 29, 23, 23, 11, 22,

1996 1996 1999 1999 1995 1992

Apr 15, 1999 Apr 15, 1999 Nov 29, 2000 Nov 29, 2000

A065060 001 A065060 002

TABLET, EXTENDED RELEASE; ORAL

MOXATAG
775MG XX + SHIONOGI INC TABLET, FOR SUSPENSION; ORAL AMOXICILLIN AUROBINDO PHARMA AB 200MG AB 400MG DISPERMOX 600MG XX + RANBAXY

N050813 001

Jan 23, 2008

A065324 001 A065324 002 A065159 001

Jan 17, 2007 Jan 17, 2007 Dec 04, 2003

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE
CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS; ORAL

PREVPAC

500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30M XX + TAKEDA PHARMS NA G

3 - 32 (of 424)

N050757 001

Dec 02, 1997

AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE

CAPSULE, TABLET, CAPSULE, DELAYED RELEASE, TABLET; ORAL

OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN
XX + GASTROENTERO 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20M G

N050824 001

Feb 08, 2011

AMOXICILLIN; CLAVULANATE POTASSIUM

FOR SUSPENSION; ORAL AMOXICILLIN AND CLAVULANATE POTASSIUM HIKMA PHARMS 200MG/5ML;EQ 28.5MG BASE/5ML 400MG/5ML;EQ 57MG BASE/5ML 600MG/5ML;EQ 42.9MG BASE/5ML LEK PHARMS 200MG/5ML;EQ 28.5MG BASE/5ML 400MG/5ML;EQ 57MG BASE/5ML LEK PHARMS DD 600MG/5ML;EQ 42.9MG BASE/5ML RANBAXY 200MG/5ML;EQ 28.5MG BASE/5ML 400MG/5ML;EQ 57MG BASE/5ML 600MG/5ML;EQ 42.9MG BASE/5ML SANDOZ 200MG/5ML;EQ 28.5MG BASE/5ML 400MG/5ML;EQ 57MG BASE/5ML TEVA 200MG/5ML;EQ 28.5MG BASE/5ML + 400MG/5ML;EQ 57MG BASE/5ML + 600MG/5ML;EQ 42.9MG BASE/5ML WOCKHARDT 250MG/5ML;EQ 62.5MG BASE/5ML AUGMENTIN '125' DR REDDYS LABS INC 125MG/5ML;EQ 31.25MG BASE/5ML AUGMENTIN '200' DR REDDYS LABS INC 200MG/5ML;EQ 28.5MG BASE/5ML AUGMENTIN '250' + DR REDDYS LABS INC 250MG/5ML;EQ 62.5MG BASE/5ML AUGMENTIN '400' DR REDDYS LABS INC 400MG/5ML;EQ 57MG BASE/5ML AUGMENTIN ES-600 DR REDDYS LABS INC 600MG/5ML;EQ 42.9MG BASE/5ML

AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB

A065191 A065191 A065373 A065098 A065098 A065358 A065132 A065132 A065207 A065066 A065066 A065089 A065089 A065162 A065431

002 001 001 001 002 001 001 002 002 001 002 001 002 001 001

Jan Jan Nov Dec Dec Aug Mar Mar Jan Jun Jun May May Mar Nov

25, 25, 09, 16, 16, 13, 19, 19, 30, 05, 05, 25, 25, 12, 25,

2005 2005 2007 2002 2002 2007 2003 2003 2007 2002 2002 2004 2004 2004 2008

N050575 001 N050725 001 N050575 002 N050725 002 N050755 001

Aug 06, 1984 May 31, 1996 Aug 06, 1984 May 31, 1996 Jun 22, 2001

SUSPENSION; ORAL AMOXICILLIN AND CLAVULANATE POTASSIUM AUROBINDO PHARMA LTD 200MG/5ML;EQ 28.5MG BASE/5ML AB AB 400MG/5ML;EQ 57MG BASE/5ML AB 600MG/5ML;EQ 42.9MG BASE/5ML TABLET; ORAL AMOXICILLIN AND CLAVULANATE POTASSIUM APOTEX AB 250MG;EQ 125MG AB 500MG;EQ 125MG APOTEX INC AB 875MG;EQ 125MG LEK PHARMS AB 500MG;EQ 125MG AB 875MG;EQ 125MG RANBAXY AB 500MG;EQ 125MG AB 875MG;EQ 125MG SANDOZ AB 250MG;EQ 125MG AB 500MG;EQ 125MG AB 875MG;EQ 125MG TEVA AB 500MG;EQ 125MG AB + 875MG;EQ 125MG

A201090 001 A201090 002 A201091 001

Dec 20, 2011 Dec 20, 2011 Dec 20, 2011

BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE

A065333 A065333 A065317 A065117 A065093 A065109 A065102 A065189 A065064 A065063 A065101 A065096

001 002 003 001 001 001 001 001 001 001 001 001

Feb Feb Oct Nov Nov Nov Sep Aug Mar Mar Oct Oct

24, 24, 20, 27, 21, 04, 17, 23, 15, 14, 30, 29,

2009 2009 2008 2002 2002 2002 2002 2005 2002 2002 2002 2002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

AMOXICILLIN; CLAVULANATE POTASSIUM
TABLET; ORAL AUGMENTIN '250' DR REDDYS LABS INC AB AUGMENTIN '500' DR REDDYS LABS INC AB AUGMENTIN '875' DR REDDYS LABS INC AB

3 - 33 (of 424)

250MG;EQ 125MG BASE 500MG;EQ 125MG BASE 875MG;EQ 125MG BASE

N050564 001 N050564 002 N050720 001

Aug 06, 1984 Aug 06, 1984 Feb 13, 1996

TABLET, CHEWABLE; ORAL AMOXICILLIN AND CLAVULANATE POTASSIUM RANBAXY AB 200MG;EQ 28.5MG BASE AB 400MG;EQ 57MG BASE SANDOZ AB 200MG;EQ 28.5MG BASE AB 400MG;EQ 57MG BASE TEVA AB 200MG;EQ 28.5MG BASE AB + 400MG;EQ 57MG BASE AUGMENTIN '125' DR REDDYS LABS INC AB 125MG;EQ 31.25MG BASE AUGMENTIN '200' DR REDDYS LABS INC AB 200MG;EQ 28.5MG BASE AUGMENTIN '250' DR REDDYS LABS INC AB 250MG;EQ 62.5MG BASE AUGMENTIN '400' DR REDDYS LABS INC AB 400MG;EQ 57MG BASE TABLET, EXTENDED RELEASE; ORAL AMOXICILLIN AND CLAVULANATE POTASSIUM SANDOZ AB 1GM;EQ 62.5MG BASE AUGMENTIN XR AB + DR REDDYS LABS INC 1GM;EQ 62.5MG BASE

A065161 A065161 A065065 A065065 A065205 A065205

001 002 001 002 001 002

Dec Dec Apr Apr Feb Feb

03, 03, 18, 18, 09, 09,

2003 2003 2002 2002 2005 2005

N050597 001 N050726 001 N050597 002 N050726 002

Jul 22, 1985 May 31, 1996 Jul 22, 1985 May 31, 1996

A090227 001 N050785 001

Apr 21, 2010 Sep 25, 2002

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

CAPSULE, EXTENDED RELEASE; ORAL ADDERALL XR 10 SHIRE 2.5MG;2.5MG;2.5MG;2.5MG ADDERALL XR 15 SHIRE 3.75MG;3.75MG;3.75MG;3.75MG ADDERALL XR 20 SHIRE 5MG;5MG;5MG;5MG ADDERALL XR 25 SHIRE 6.25MG;6.25MG;6.25MG;6.25MG ADDERALL XR 30 + SHIRE 7.5MG;7.5MG;7.5MG;7.5MG ADDERALL XR 5 SHIRE 1.25MG;1.25MG;1.25MG;1.25MG

XX XX XX XX XX XX

N021303 001 N021303 006 N021303 002 N021303 004 N021303 003 N021303 005

Oct 11, 2001 May 22, 2002 Oct 11, 2001 May 22, 2002 Oct 11, 2001 May 22, 2002

TABLET; ORAL DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE BARR AB 1.25MG;1.25MG;1.25MG;1.25MG A040422 AB 1.875MG;1.875MG;1.875MG;1.875MG A040422 AB 2.5MG;2.5MG;2.5MG;2.5MG A040422 AB 3.125MG;3.125MG;3.125MG;3.125MG A040422 AB 3.75MG;3.75MG;3.75MG;3.75MG A040422 AB 5MG;5MG;5MG;5MG A040422 AB + 7.5MG;7.5MG;7.5MG;7.5MG A040422 COREPHARMA AB 1.25MG;1.25MG;1.25MG;1.25MG A040444 AB 2.5MG;2.5MG;2.5MG;2.5MG A040444 AB 5MG;5MG;5MG;5MG A040444 AB 7.5MG;7.5MG;7.5MG;7.5MG A040444 SANDOZ AB 1.25MG;1.25MG;1.25MG;1.25MG A040439 AB 2.5MG;2.5MG;2.5MG;2.5MG A040439

001 005 002 006 007 003 004 001 002 003 004 004 001

Feb Mar Feb Mar Mar Feb Feb Jun Jun Jun Jun Sep Jun

11, 19, 11, 19, 19, 11, 11, 19, 19, 19, 19, 27, 14,

2002 2003 2002 2003 2003 2002 2002 2002 2002 2002 2002 2002 2002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
TABLET; ORAL DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE SANDOZ AB 5MG;5MG;5MG;5MG A040439 AB 7.5MG;7.5MG;7.5MG;7.5MG A040439 TEVA PHARMS AB 1.25MG;1.25MG;1.25MG;1.25MG A040472 AB 2.5MG;2.5MG;2.5MG;2.5MG A040472 AB 5MG;5MG;5MG;5MG A040472 AB 7.5MG;7.5MG;7.5MG;7.5MG A040472

3 - 34 (of 424)

002 003 001 002 003 004

Jun Jun Sep Sep Sep Sep

14, 14, 30, 30, 30, 30,

2002 2002 2003 2003 2003 2003

AMPHOTERICIN B
INJECTABLE; INJECTION AMPHOTERICIN B AP + X GEN PHARMS

50MG/VIAL

A063206 001

Apr 29, 1992

INJECTABLE, LIPID COMPLEX; INJECTION

ABELCET

5MG/ML XX + SIGMA TAU AMPHOTEC 50MG/VIAL XX + ALDOPHARMA USA 100MG/VIAL XX + INJECTABLE, LIPOSOMAL; INJECTION

AMBISOME

50MG/VIAL XX + ASTELLAS

N050724 001 N050729 001 N050729 002

Nov 20, 1995 Nov 22, 1996 Nov 22, 1996

N050740 001

Aug 11, 1997

AMPICILLIN SODIUM
INJECTABLE; INJECTION AMPICILLIN SODIUM ACIC FINE CHEMS AP AP AP AP AUROBINDO PHARMA AP AP AP AP AP AP HANFORD GC AP AP AP AP AP IBI AP AP AP INSTITUTO BIOCHEMICO AP AP AP + SANDOZ AP + AP + AP + AP AP + AP AP +

EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ

250MG BASE/VIAL 500MG BASE/VIAL 1GM BASE/VIAL 2GM BASE/VIAL 125MG BASE/VIAL 250MG BASE/VIAL 500MG BASE/VIAL 1GM BASE/VIAL 2GM BASE/VIAL 10GM BASE/VIAL 250MG BASE/VIAL 500MG BASE/VIAL 1GM BASE/VIAL 2GM BASE/VIAL 10GM BASE/VIAL 250MG BASE/VIAL 500MG BASE/VIAL 1GM BASE/VIAL 125MG BASE/VIAL 2GM BASE/VIAL 125MG BASE/VIAL 250MG BASE/VIAL 500MG BASE/VIAL 1GM BASE/VIAL 1GM BASE/VIAL 2GM BASE/VIAL 2GM BASE/VIAL 10GM BASE/VIAL

A090354 A090354 A090354 A090354 A065499 A065499 A065499 A065499 A065499 A065493 A063145 A063146 A062772 A063140 A063142 A062719 A062719 A062719 A062797 A062797 A061395 A061395 A061395 A061395 A062738 A061395 A062738 A061395

001 002 003 004 001 002 003 004 005 001 001 001 001 001 001 001 003 002 001 002 001 002 003 004 001 005 002 006

Dec Dec Dec Dec Aug Aug Aug Aug Aug Aug Apr Apr Apr Apr Apr May May May Jul Jul

28, 28, 28, 28, 17, 17, 17, 17, 17, 17, 15, 15, 15, 15, 15, 12, 12, 12, 12, 12,

2009 2009 2009 2009 2010 2010 2010 2010 2010 2010 1993 1993 1993 1993 1993 1987 1987 1987 1993 1993

Feb 19, 1987 Feb 19, 1987

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

AMPICILLIN SODIUM; SULBACTAM SODIUM
INJECTABLE; INJECTION AMPICILLIN AND SULBACTAM ACS DOBFAR EQ EQ EQ AUROBINDO PHARMA EQ EQ EQ EQ EQ BAXTER HLTHCARE EQ EQ EQ BIONICHE PHARMA EQ EQ HANFORD GC EQ EQ EQ HOSPIRA INC EQ EQ EQ EQ EQ INSTITUTO BIOCHIMICO EQ EQ EQ SANDOZ EQ EQ EQ EQ EQ UNASYN PFIZER EQ + EQ + EQ + EQ

3 - 35 (of 424)

AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP

1GM BASE/VIAL;EQ 500MG BASE/VIAL 2GM BASE/VIAL;EQ 1GM BASE/VIAL 10GM BASE/VIAL;EQ 5GM BASE/VIAL 1GM BASE/VIAL;EQ 500MG BASE/VIAL 1GM BASE/VIAL;EQ 500MG BASE/VIAL 2GM BASE/VIAL;EQ 1GM BASE/VIAL 2GM BASE/VIAL;EQ 1GM BASE/VIAL 10GM BASE/VIAL;EQ 5GM BASE/VIAL 1GM BASE/VIAL;EQ 500MG BASE/VIAL 2GM BASE/VIAL;EQ 1GM BASE/VIAL 10GM BASE/VIAL;EQ 5GM BASE/VIAL 1GM BASE/VIAL;EQ 500MG BASE/VIAL 2GM BASE/VIAL;EQ 1GM BASE/VIAL 1GM BASE/VIAL;EQ 500MG BASE/VIAL 2GM BASE/VIAL;EQ 1GM BASE/VIAL 10GM BASE/VIAL;EQ 5GM BASE/VIAL 1GM BASE/VIAL;EQ 500MG BASE/VIAL 1GM BASE/VIAL;EQ 500MG BASE/VIAL 2GM BASE/VIAL;EQ 1GM BASE/VIAL 2GM BASE/VIAL;EQ 1GM BASE/VIAL 10GM BASE/VIAL;EQ 5GM BASE/VIAL 1GM BASE/VIAL;EQ 500MG BASE/VIAL 2GM BASE/VIAL;EQ 1GM BASE/VIAL 10GM BASE/VIAL;EQ 5GM BASE/VIAL 1GM BASE/VIAL;EQ 500MG BASE/VIAL 1GM BASE/VIAL;EQ 500MG BASE/VIAL 2GM BASE/VIAL;EQ 1GM BASE/VIAL 2GM BASE/VIAL;EQ 1GM BASE/VIAL 10GM BASE/VIAL;EQ 5GM BASE/VIAL 1GM BASE/VIAL;EQ 500MG BASE/VIAL 1GM BASE/VIAL;EQ 500MG BASE/VIAL 2GM BASE/VIAL;EQ 1GM BASE/VIAL 10GM BASE/VIAL;EQ 5GM BASE/VIAL

A065406 A065406 A065403 A090340 A090349 A090340 A090349 A090339 A065074 A065074 A065076 A065316 A065316 A065176 A065176 A065188 A090375 A090653 A090375 A090653 A090646 A065222 A065222 A065314 A065241 A065310 A065241 A065310 A065240 A062901 N050608 N050608 N050608

001 002 001 001 001 002 002 001 001 002 001 001 002 001 002 001 001 001 002 002 001 001 002 001 001 001 002 002 001 001 002 001 005

Dec Dec Dec Sep Sep Sep Sep Sep Mar Mar Mar Jun Jun Nov Nov Nov Dec Dec Dec Dec Dec Nov Nov Nov Jul Jul Jul Jul Jul Nov Dec Dec Dec

22, 22, 23, 20, 20, 20, 20, 20, 19, 19, 19, 29, 29, 30, 30, 25, 21, 21, 21, 21, 21, 29, 29, 27, 25, 25, 25, 25, 25, 23, 31, 31, 10,

2009 2009 2009 2010 2010 2010 2010 2010 2002 2002 2002 2007 2007 2005 2005 2005 2011 2011 2011 2011 2011 2005 2005 2006 2006 2006 2006 2006 2006 1988 1986 1986 1993

AMPICILLIN/AMPICILLIN TRIHYDRATE
CAPSULE; ORAL AMPICILLIN TRIHYDRATE DAVA PHARMS INC AB AB + SANDOZ AB AB FOR SUSPENSION; ORAL AMPICILLIN TRIHYDRATE DAVA PHARMS INC XX XX +

EQ EQ EQ EQ

250MG 500MG 250MG 500MG

BASE BASE BASE BASE

A062883 A062882 A064082 A064082

001 001 001 002

Feb Feb Aug Aug

25, 25, 29, 29,

1988 1988 1995 1995

EQ 125MG BASE/5ML EQ 250MG BASE/5ML

A062982 001 A062982 002

Feb 10, 1989 Feb 10, 1989

ANAGRELIDE HYDROCHLORIDE
CAPSULE; ORAL AGRYLIN SHIRE EQ ANAGRELIDE HYDROCHLORIDE ALPHAPHARM EQ EQ BARR EQ EQ IMPAX LABS EQ

AB AB AB AB AB AB

0.5MG BASE 0.5MG BASE 1MG BASE 0.5MG BASE 1MG BASE 0.5MG BASE

N020333 001 A077613 A077613 A076530 A076530 A076910 001 002 001 002 001

Mar 14, 1997 Jun Jun Apr Apr Apr 27, 27, 18, 18, 18, 2006 2006 2005 2005 2005

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

ANAGRELIDE HYDROCHLORIDE
CAPSULE; ORAL ANAGRELIDE HYDROCHLORIDE IMPAX LABS EQ IVAX SUB TEVA PHARMS EQ + EQ MYLAN EQ EQ SANDOZ EQ EQ WATSON LABS EQ EQ

3 - 36 (of 424)

AB AB AB AB AB AB AB AB AB

1MG BASE 0.5MG BASE 1MG BASE 0.5MG BASE 1MG BASE 0.5MG BASE 1MG BASE 0.5MG BASE 1MG BASE

A076910 A076468 A076468 A076811 A076811 A076683 A076683 A076417 A076417

002 001 002 001 002 001 002 001 002

Apr Apr Apr Apr Apr Apr Apr Apr Apr

18, 18, 18, 18, 18, 18, 18, 18, 18,

2005 2005 2005 2005 2005 2005 2005 2005 2005

ANASTROZOLE
TABLET; ORAL ANASTROZOLE ACCORD HLTHCARE INC DR REDDYS LABS LTD FRESENIUS KABI ONCOL KUDCO IRELAND MYLAN NATCO PHARMA LTD ROXANE SANDOZ SANTOS BIOTECH SUN PHARM INDS LTD TEVA PHARMS THREE RIVERS PHARMS WATSON LABS ZYDUS PHARMS USA INC ARIMIDEX + ASTRAZENECA

AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB

1MG 1MG 1MG 1MG 1MG 1MG 1MG 1MG 1MG 1MG 1MG 1MG 1MG 1MG 1MG

A090568 A090732 A090088 A091331 A091051 A079220 A078485 A079007 A078944 A091177 A078058 A091164 A078984 A078921

001 001 001 001 001 001 001 001 001 001 001 001 001 001

Jun Jun Jun Jan Jun Jun Jun Jun Jun Jul Jun Jun Jun Jun

28, 28, 28, 05, 28, 28, 28, 28, 28, 15, 28, 28, 28, 28,

2010 2010 2010 2011 2010 2010 2010 2010 2010 2011 2010 2010 2010 2010

N020541 001

Dec 27, 1995

ANIDULAFUNGIN
INJECTABLE; IV (INFUSION)
ERAXIS
XX + VICURON 50MG/VIAL XX + 100MG/VIAL

N021632 001 N021632 002

Feb 17, 2006 Nov 14, 2006

APOMORPHINE HYDROCHLORIDE

INJECTABLE; SUBCUTANEOUS

APOKYN
XX + US WORLDMEDS

30MG/3ML (10MG/ML)

N021264 002

Apr 20, 2004

APRACLONIDINE HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC APRACLONIDINE HYDROCHLORIDE AKORN INC AT EQ 0.5% BASE IOPIDINE AT + ALCON EQ 0.5% BASE IOPIDINE EQ 1% BASE XX + ALCON

A077764 001 N020258 001 N019779 001

Mar 12, 2009 Jul 30, 1993 Dec 31, 1987

APREPITANT
CAPSULE; ORAL EMEND MERCK XX XX XX +

40MG 80MG 125MG

N021549 003 N021549 001 N021549 002

Jun 30, 2006 Mar 26, 2003 Mar 26, 2003

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

APROTININ
INJECTABLE; INJECTION
TRASYLOL
XX + BAYER HLTHCARE

3 - 37 (of 424)

10,000KIU/ML

N020304 001

Dec 29, 1993

ARFORMOTEROL TARTRATE
SOLUTION; INHALATION
BROVANA
XX + SUNOVION

EQ 0.015MG BASE/2ML

N021912 001

Oct 06, 2006

ARGATROBAN
INJECTABLE; INJECTION
ARGATROBAN
XX + PFIZER

100MG/ML

N020883 001

Jun 30, 2000

INJECTABLE; IV (INFUSION)
ARGATROBAN IN SODIUM CHLORIDE
XX + EAGLE PHARMS 50MG/50ML (1MG/ML) XX + SANDOZ 125MG/125ML (1MG/ML)

N022434 001 N022485 001

Jun 29, 2011

May 09, 2011

ARGININE HYDROCHLORIDE
INJECTABLE; INJECTION
R-GENE 10
XX + PHARMACIA AND UPJOHN 10GM/100ML

N016931 001

ARIPIPRAZOLE
INJECTABLE; INTRAMUSCULAR
ABILIFY
XX + OTSUKA 9.75MG/1.3ML (7.5MG/ML) SOLUTION; ORAL

ABILIFY

XX + OTSUKA TABLET; ORAL
ABILIFY
OTSUKA
XX XX +
XX +
XX XX XX

N021866 001

Sep 20, 2006

1MG/ML

N021713 001

Dec 10, 2004

2MG 5MG 10MG 15MG 20MG 30MG

N021436 N021436 N021436 N021436 N021436 N021436

006 005 001 002 003 004

Nov Nov Nov Nov Nov Nov

15, 15, 15, 15, 15, 15,

2002 2002 2002 2002 2002 2002

TABLET, ORALLY DISINTEGRATING; ORAL

ABILIFY
XX + OTSUKA 10MG XX 15MG

N021729 002 N021729 003

Jun 07, 2006 Jun 07, 2006

ARMODAFINIL
TABLET; ORAL
NUVIGIL
CEPHALON
XX XX XX +

50MG 150MG 250MG

N021875 001 N021875 003 N021875 004

Jun 15, 2007 Jun 15, 2007 Jun 15, 2007

ARSENIC TRIOXIDE
INJECTABLE; INJECTION
TRISENOX
XX + CEPHALON

1MG/ML

N021248 001

Sep 25, 2000

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

ARTEMETHER; LUMEFANTRINE

TABLET; ORAL

COARTEM
XX + NOVARTIS

3 - 38 (of 424)

20MG;120MG

N022268 001

Apr 07, 2009

ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

INJECTABLE; INJECTION ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE HOSPIRA AP 4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML) SEPTOCAINE AP + DEPROCO 4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML) ARTICAINE HYDROCHLORIDE WITH EPINEPHRINE PIERREL 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG XX BASE/ML) 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG XX +
BASE/ML)

SEPTOCAINE
4%;EQ 0.0085MG BASE/1.7ML (4%;EQ XX + DEPROCO 0.005MG BASE/ML)

A079138 001

Jun 18, 2010

N020971 001

Apr 03, 2000

N022466 001 N022466 002

Feb 26, 2010 Feb 26, 2010

N022010 001

Mar 30, 2006

ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL ACETATE; VITAMIN A; VITAMIN K

INJECTABLE; IV (INFUSION)

INFUVITE PEDIATRIC
80MG/VIAL;0.02MG/VIAL;400 XX + SANDOZ IU/VIAL;0.001MG/VIAL;5MG/VIAL;0.14MG/VI AL;17MG/VIAL;1MG/VIAL;1.4MG/VIAL;1.2MG/ VIAL;7 IU/VIAL;2,300 IU/VIAL;0.2MG/VIAL XX INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) + SANDOZ 80MG/VIAL;0.02MG/VIAL;400 IU/VIAL;0.001MG/VIAL;5MG/VIAL;0.14MG/VI AL;17MG/VIAL;1MG/VIAL;1.4MG/VIAL;1.2MG/ VIAL;7 IU/VIAL;2,300 IU/VIAL;0.2MG/VIAL

N021265 001

Feb 21, 2001

N021646 001

Jan 29, 2004

ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PHYTONADIONE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E
FOR SOLUTION; IV (INFUSION) M.V.I. PEDIATRIC XX + HOSPIRA 80MG/VIAL;0.02MG/VIAL;0.001MG/VIAL;5MG/ VIAL;0.01MG/VIAL;0.14MG/VIAL;17MG/VIAL; 0.2MG/VIAL;1MG/VIAL;1.4MG/VIAL;EQ 1.2MG BASE/VIAL;0.7MG/VIAL;7MG/VIAL

N018920 001

Sep 21, 2000

ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E

INJECTABLE; INJECTION

M.V.I.-12 (WITHOUT VITAMIN K)
XX + HOSPIRA 20MG/ML;0.006MG/ML;0.05MCG/ML;1.5MG/ML; 0.0005MG/ML;0.06MG/ML;4MG/ML;0.6MG/ML;0 .36MG/ML;0.6MG/ML;0.1MG/ML;1MG/ML

N008809 006

Sep 09, 2004

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 39 (of 424)

ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E; VITAMIN K
INJECTABLE; IV (INFUSION) M.V.I. ADULT XX + HOSPIRA 200MG/VIAL;0.06MG/VIAL;0.005MG/VIAL;15M G/VIAL;0.005MG/VIAL;0.6MG/VIAL;40MG/VIA L;6MG/VIAL;3.6MG/VIAL;6MG/VIAL;1MG/VIAL ;10MG/VIAL;0.15MG/VIAL XX M.V.I. ADULT (PHARMACY BULK PACKAGE) + HOSPIRA 200MG/5ML;0.06MG/5ML;0.005MG/5ML;15MG/5 ML;0.005MG/5ML;0.6MG/5ML;40MG/5ML;6MG/5 ML;3.6MG/5ML;6MG/5ML;1MG/5ML;10MG/5ML;0 .15MG/5ML

N021625 001

Jan 30, 2004

N021643 001

Feb 18, 2004

ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE

FOR SOLUTION; ORAL

MOVIPREP
XX + SALIX PHARMS

4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM

N021881 001

Aug 02, 2006

ASENAPINE MALEATE
TABLET; SUBLINGUAL SAPHRIS XX ORGANON USA INC XX +

EQ 5MG BASE EQ 10MG BASE

N022117 001 N022117 002

Aug 13, 2009 Aug 13, 2009

ASPIRIN; BUTALBITAL; CAFFEINE

CAPSULE; ORAL FIORINAL AA + WATSON LABS INC LANORINAL LANNETT AA

325MG;50MG;40MG 325MG;50MG;40MG

N017534 005 A086996 002

Apr 16, 1986 Oct 11, 1985

TABLET; ORAL BUTALBITAL, ASPIRIN AND CAFFEINE AA + WEST WARD 325MG;50MG;40MG

A086162 002

Feb 16, 1984

ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE

CAPSULE; ORAL BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE NEXGEN PHARMA INC 325MG;50MG;40MG;30MG STEVENS J 325MG;50MG;40MG;30MG WATSON LABS 325MG;50MG;40MG;30MG FIORINAL W/CODEINE + WATSON LABS INC 325MG;50MG;40MG;30MG

AB AB AB AB

A075231 001 A074951 001 A074359 001 N019429 003

Nov 30, 2001 Aug 31, 1998 Aug 31, 1995 Oct 26, 1990

ASPIRIN; CAFFEINE; DIHYDROCODEINE BITARTRATE

CAPSULE; ORAL

SYNALGOS-DC

XX + CARACO

356.4MG;30MG;16MG

N011483 004

Sep 06, 1983

ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE

TABLET; ORAL INVAGESIC SANDOZ INVAGESIC FORTE SANDOZ NORGESIC MEDICIS NORGESIC FORTE + MEDICIS

AB AB AB AB

385MG;30MG;25MG 770MG;60MG;50MG 385MG;30MG;25MG 770MG;60MG;50MG

A074817 001 A074817 002 N013416 003 N013416 004

Nov 27, 1996 Nov 27, 1996 Oct 27, 1982 Oct 27, 1982

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE
TABLET; ORAL ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE SANDOZ AB 385MG;30MG;25MG AB 770MG;60MG;50MG STEVENS J AB 385MG;30MG;25MG AB 770MG;60MG;50MG

3 - 40 (of 424)

A074654 A074654 A074988 A074988

001 002 001 002

Dec Dec Apr Apr

31, 31, 30, 30,

1996 1996 1999 1999

ASPIRIN; CARISOPRODOL
TABLET; ORAL CARISOPRODOL AND ASPIRIN HERITAGE PHARMS INC 325MG;200MG MIRROR PHARMS 325MG;200MG PROSAM LABS 325MG;200MG SANDOZ 325MG;200MG SOMA COMPOUND + MEDA PHARMS 325MG;200MG

AB AB AB AB AB

A089594 A040832 A040252 A040116

001 001 001 001

Mar Jan Dec Apr

31, 07, 10, 25,

1989 2010 1997 1996

N012365 005

Jul 11, 1983

ASPIRIN; CARISOPRODOL; CODEINE PHOSPHATE

TABLET; ORAL CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE MIRROR PHARMS 325MG;200MG;16MG PROSAM LABS 325MG;200MG;16MG SANDOZ 325MG;200MG;16MG SOMA COMPOUND W/ CODEINE + MEDA PHARMS 325MG;200MG;16MG

AB AB AB AB

A040860 001 A040283 001 A040118 001 N012366 002

Jan 07, 2010 Dec 29, 1998 Apr 16, 1996 Jul 11, 1983

ASPIRIN; DIPYRIDAMOLE
CAPSULE, EXTENDED RELEASE; ORAL AGGRENOX AB + BOEHRINGER INGELHEIM 25MG;200MG ASPIRIN AND DIPYRIDAMOLE BARR AB 25MG;200MG

N020884 001 A078804 001

Nov 22, 1999 Aug 14, 2009

ASPIRIN; METHOCARBAMOL
TABLET; ORAL
METHOCARBAMOL AND ASPIRIN
325MG;400MG XX + STEVENS J

A081145 001

Jan 31, 1995

ASPIRIN; OXYCODONE HYDROCHLORIDE

TABLET; ORAL OXYCODONE AND ASPIRIN COASTAL PHARMS AA WATSON LABS AA PERCODAN AA + ENDO PHARMS

325MG;4.8355MG 325MG;4.8355MG 325MG;4.8355MG

A091670 001 A090084 001 N007337 007

Mar 16, 2011 Mar 22, 2011 Aug 05, 2005

ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE

TABLET; ORAL OXYCODONE AND ASPIRIN WATSON LABS XX

325MG;4.5MG;0.38MG

A040255 001

Feb 27, 1998

ATAZANAVIR SULFATE
CAPSULE; ORAL REYATAZ BRISTOL MYERS SQUIBB XX XX XX XX +

EQ EQ EQ EQ

100MG 150MG 200MG 300MG

BASE BASE BASE BASE

N021567 N021567 N021567 N021567

001 002 003 004

Jun Jun Jun Oct

20, 20, 20, 16,

2003 2003 2003 2006

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

ATENOLOL
TABLET; ORAL ATENOLOL AUROBINDO PHARMA AB AB AB CARACO AB AB AB DAVA PHARMS INC AB AB AB IPCA LABS LTD AB AB AB IPR AB AB AB MUTUAL PHARM AB AB AB MYLAN AB AB AB AB AB AB NORTHSTAR HLTHCARE AB AB AB SANDOZ AB AB AB TEVA AB AB AB UNIQUE PHARM LABS AB AB AB WATSON LABS AB AB ZYDUS PHARMS USA AB AB AB TENORMIN ASTRAZENECA AB AB AB +

3 - 41 (of 424)

25MG 50MG 100MG 25MG 50MG 100MG 25MG 50MG 100MG 25MG 50MG 100MG 25MG 50MG 100MG 25MG 50MG 100MG 25MG 25MG 50MG 50MG 100MG 100MG 25MG 50MG 100MG 25MG 50MG 100MG 25MG 50MG 100MG 25MG 50MG 100MG 50MG 100MG 25MG 50MG 100MG 25MG 50MG 100MG

A078512 A078512 A078512 A078210 A078210 A078210 A074099 A073542 A073543 A077877 A077877 A077877 A073646 A072303 A072304 A074499 A073475 A073476 A073457 A074126 A073456 A074126 A073457 A074126 A078254 A078254 A078254 A074052 A073025 A073026 A074056 A074056 A074056 A077443 A077443 A077443 A073352 A073353 A076900 A076900 A076900

001 002 003 001 002 003 001 001 001 001 002 003 001 001 001 001 001 001 002 003 001 001 001 002 001 002 003 001 001 001 003 001 002 001 002 003 001 001 001 002 003

Oct Oct Oct Jul Jul Jul Apr Dec Dec Dec Dec Dec Jul Jul Jul Jul Mar Mar Apr Aug Jan Mar Jan Mar Sep Sep Sep May Sep Sep Jul Jan Jan Sep Sep Sep Dec Dec Jan Jan Jan

31, 31, 31, 10, 10, 10, 28, 19, 19, 27, 27, 27, 31, 15, 15, 30, 30, 30, 26, 26, 24, 23, 24, 23, 25, 25, 25, 01, 17, 17, 19, 18, 18, 13, 13, 13, 27, 27, 28, 28, 28,

2007 2007 2007 2007 2007 2007 1992 1991 1991 2006 2006 2006 1992 1988 1988 1997 1993 1993 1999 1998 1992 1994 1992 1994 2009 2009 2009 1992 1991 1991 2004 1995 1995 2006 2006 2006 1991 1991 2005 2005 2005

N018240 004 N018240 001 N018240 002

Apr 09, 1990

ATENOLOL; CHLORTHALIDONE
TABLET; ORAL ATENOLOL AND CHLORTHALIDONE IPR AB 50MG;25MG AB 100MG;25MG MUTUAL PHARM AB 50MG;25MG AB 100MG;25MG MYLAN AB 50MG;25MG 100MG;25MG AB WATSON LABS AB 50MG;25MG AB 100MG;25MG

A072301 A072302 A073581 A073582 A074203 A074203 A073665 A073665

001 001 001 001 001 002 001 002

May May Apr Apr Oct Oct Jul Jul

31, 31, 29, 29, 31, 31, 02, 02,

1990 1990 1993 1993 1993 1993 1992 1992

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

ATENOLOL; CHLORTHALIDONE
TABLET; ORAL TENORETIC 100 AB + ASTRAZENECA TENORETIC 50 ASTRAZENECA AB

3 - 42 (of 424)

100MG;25MG 50MG;25MG

N018760 001 N018760 002

Jun 08, 1984 Jun 08, 1984

ATOMOXETINE HYDROCHLORIDE
CAPSULE; ORAL ATOMOXETINE HYDROCHLORIDE AUROBINDO PHARM AB 10MG AB 18MG AB 25MG AB 40MG AB 60MG AB 80MG AB 100MG MYLAN AB 10MG AB 18MG AB 25MG AB 40MG AB 60MG AB 80MG AB 100MG SANDOZ AB 10MG AB 18MG AB 25MG AB 40MG AB 60MG AB 80MG AB 100MG SUN PHARMA GLOBAL AB 10MG AB 18MG AB 25MG AB 40MG AB 60MG AB 80MG AB 100MG TEVA PHARMS AB 10MG AB 18MG AB 25MG AB 40MG AB 60MG AB 80MG AB 100MG ZYDUS PHARMS USA INC 18MG AB AB 25MG AB 40MG AB 60MG AB 80MG AB 100MG STRATTERA LILLY AB 10MG AB 18MG AB 25MG AB 40MG AB + 60MG AB 80MG AB 100MG

A079016 A079016 A079016 A079016 A079016 A079016 A079016 A079021 A079021 A079021 A079021 A079021 A079021 A079021 A079018 A079018 A079018 A079018 A079018 A079018 A079018 A079020 A079020 A079020 A079020 A079020 A079020 A079020 A079022 A079022 A079022 A079022 A079022 A079022 A079022 A079017 A079017 A079017 A079017 A079017 A079017 N021411 N021411 N021411 N021411 N021411 N021411 N021411

001 002 003 004 005 006 007 001 002 003 004 005 006 007 001 002 003 004 005 006 007 001 002 003 004 005 006 007 001 002 003 004 005 006 007 001 002 003 004 005 006 002 003 004 005 006 007 008

Sep Sep Sep Sep Sep Sep Sep Aug Aug Aug Aug Aug Aug Aug Sep Sep Sep Sep Sep Sep Sep Aug Aug Aug Aug Aug Aug Aug Oct Oct Oct Oct Oct Oct Oct Sep Sep Sep Sep Sep Sep Nov Nov Nov Nov Nov Feb Feb

13, 13, 13, 13, 13, 13, 13, 30, 30, 30, 30, 30, 30, 30, 13, 13, 13, 13, 13, 13, 13, 30, 30, 30, 30, 30, 30, 30, 01, 01, 01, 01, 01, 01, 01, 17, 17, 17, 17, 17, 17, 26, 26, 26, 26, 26, 14, 14,

2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2002 2002 2002 2002 2002 2005 2005

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

ATORVASTATIN CALCIUM
TABLET; ORAL ATORVASTATIN CALCIUM RANBAXY LABS LTD AB AB AB AB LIPITOR PFIZER AB AB AB AB +

3 - 43 (of 424)

EQ EQ EQ EQ EQ EQ EQ EQ

10MG 20MG 40MG 80MG 10MG 20MG 40MG 80MG

BASE BASE BASE BASE BASE BASE BASE BASE

A076477 A076477 A076477 A076477 N020702 N020702 N020702 N020702

001 002 003 004 001 002 003 004

Nov Nov Nov Nov Dec Dec Dec Apr

30, 30, 30, 30, 17, 17, 17, 07,

2011 2011 2011 2011 1996 1996 1996 2000

ATOVAQUONE
SUSPENSION; ORAL

MEPRON

XX + GLAXOSMITHKLINE LLC

750MG/5ML

N020500 001

Feb 08, 1995

ATOVAQUONE; PROGUANIL HYDROCHLORIDE

TABLET; ORAL ATOVAQUONE AND PROGUANIL HYDROCHLORIDE GLENMARK GENERICS AB 250MG;100MG MALARONE AB + GLAXOSMITHKLINE 250MG;100MG MALARONE PEDIATRIC GLAXOSMITHKLINE 62.5MG;25MG XX

A091211 001 N021078 001 N021078 002

Jan 12, 2011 Jul 14, 2000 Jul 14, 2000

ATRACURIUM BESYLATE

INJECTABLE; INJECTION

ATRACURIUM BESYLATE
10MG/ML XX + BEDFORD ATRACURIUM BESYLATE PRESERVATIVE FREE 10MG/ML XX + BEDFORD

A074901 001 A074900 001

Jul 18, 1997 Jul 18, 1997

ATROPINE

INJECTABLE; INJECTION

ATROPEN
+ MERIDIAN MEDCL TECHN + + +

XX XX XX XX

EQ EQ EQ EQ

0.25MG SULFATE/0.3ML 0.5MG SULFATE/0.7ML 1MG SULFATE/0.7ML 2MG SULFATE/0.7ML

N017106 N017106 N017106 N017106

004 003 002 001

Sep 17, 2004 Jun 19, 2003 Jun 19, 2003

ATROPINE SULFATE
INJECTABLE; IM-IV-SC ATROPINE SULFATE ANSYR PLASTIC SYRINGE XX HOSPIRA 0.05MG/ML XX + 0.1MG/ML

N021146 002 N021146 001

Jul 09, 2001 Jul 09, 2001

ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE

TABLET; ORAL

MOTOFEN
XX + VALEANT

0.025MG;1MG

N017744 002

ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE

SOLUTION; ORAL DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE ROXANE AA 0.025MG/5ML;2.5MG/5ML LOMOTIL AA + GD SEARLE LLC 0.025MG/5ML;2.5MG/5ML

A087708 001 N012699 001

May 03, 1982

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE
TABLET; ORAL DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE LANNETT 0.025MG;2.5MG MYLAN 0.025MG;2.5MG PAR PHARM 0.025MG;2.5MG LOMOTIL + GD SEARLE LLC 0.025MG;2.5MG LONOX SANDOZ 0.025MG;2.5MG

3 - 44 (of 424)

AA AA AA AA AA

A085372 001 A085762 001 A040357 001 N012462 001 A085311 002

May 02, 2000

ATROPINE SULFATE; EDROPHONIUM CHLORIDE

INJECTABLE; INJECTION

ENLON-PLUS

XX + MYLAN INSTITUTIONAL

0.14MG/ML;10MG/ML

N019678 001

Nov 06, 1991

ATROPINE; PRALIDOXIME CHLORIDE

INJECTABLE; INTRAMUSCULAR

DUODOTE

2.1MG/0.7ML;600MG/2ML XX + MERIDIAN MEDCL

N021983 001

Sep 28, 2006

AURANOFIN

CAPSULE; ORAL

RIDAURA
XX + PROMETHEUS LABS

3MG

N018689 001

May 24, 1985

AZACITIDINE
INJECTABLE; IV-SC

VIDAZA

XX + CELGENE

100MG/VIAL

N050794 001

May 19, 2004

AZATHIOPRINE
TABLET; ORAL AZASAN AAIPHARMA LLC AB AB AB AB AZATHIOPRINE MYLAN AB ROXANE AB ZYDUS PHARMS USA AB AB AB AB IMURAN AB + PROMETHEUS LABS

25MG 50MG 75MG 100MG 50MG 50MG 25MG 50MG 75MG 100MG 50MG

A075252 A075252 A075252 A075252 A075568 A074069 A077621 A077621 A077621 A077621

002 001 003 004 001 001 002 001 003 004

Feb Jun Feb Feb Dec Feb Sep Mar Sep Sep

03, 07, 03, 03, 13, 16, 05, 15, 05, 05,

2003 1999 2003 2003 1999 1996 2008 2007 2008 2008

N016324 001

AZATHIOPRINE SODIUM

INJECTABLE; INJECTION

AZATHIOPRINE SODIUM
XX + BEDFORD

EQ 100MG BASE/VIAL

A074419 001

Mar 31, 1995

AZELAIC ACID

CREAM; TOPICAL

AZELEX
XX + ALLERGAN

20%

N020428 001

Sep 13, 1995

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

AZELAIC ACID
GEL; TOPICAL

FINACEA

XX + INTENDIS

3 - 45 (of 424)

15%

N021470 001

Dec 24, 2002

AZELASTINE HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC AZELASTINE HYDROCHLORIDE APOTEX INC AT 0.05% SUN PHARMA GLOBAL AT 0.05% OPTIVAR AT + MEDA PHARMS 0.05% SPRAY, METERED; NASAL ASTELIN AB + MEDA PHARMS EQ 0.125MG BASE/SPRAY AZELASTINE HYDROCHLORIDE APOTEX INC AB EQ 0.125MG BASE/SPRAY ASTEPRO EQ 0.1876MG BASE/SPRAY XX + MEDA PHARMS

A078621 001 A078738 001 N021127 001

Aug 03, 2009 Jun 21, 2010 May 22, 2000

N020114 001 A077954 001 N022371 001

Nov 01, 1996 Apr 30, 2009 Aug 31, 2009

AZILSARTAN KAMEDOXOMIL
TABLET; ORAL EDARBI XX TAKEDA PHARMS XX +

EQ 40MG MEDOXOMIL EQ 80MG MEDOXOMIL

N200796 001 N200796 002

Feb 25, 2011 Feb 25, 2011

AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE

TABLET; ORAL EDARBYCLOR TAKEDA PHARMS XX XX +

EQ 40MG MEDOXOMIL;12.5MG EQ 40MG MEDOXOMIL;25MG

N202331 001 N202331 002

Dec 20, 2011 Dec 20, 2011

AZITHROMYCIN
FOR SUSPENSION; ORAL AZITHROMYCIN PLIVA AB AB SANDOZ AB AB TEVA PHARMS AB AB ZITHROMAX PFIZER AB AB + ZITHROMAX XX + PFIZER

EQ EQ EQ EQ EQ EQ

100MG 200MG 100MG 200MG 100MG 200MG

BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML

A065246 A065246 A065297 A065297 A065419 A065419

002 001 001 002 001 002

Jul Jul Sep Sep Jun Jun

05, 05, 18, 18, 24, 24,

2006 2006 2006 2006 2008 2008

EQ 100MG BASE/5ML EQ 200MG BASE/5ML EQ 1GM BASE/PACKET

N050710 001 N050710 002 N050693 001

Oct 19, 1995 Oct 19, 1995 Sep 28, 1994

FOR SUSPENSION, EXTENDED RELEASE; ORAL

ZMAX

EQ 2GM BASE/BOT XX + PFIZER GLOBAL INJECTABLE; INJECTION AZITHROMYCIN APP PHARMS AP GLAND PHARMA LTD AP HOSPIRA AP AP PLIVA HRVATSKA DOO AP SAGENT STRIDES AP AP + TEVA PARENTERAL

N050797 001

Jun 10, 2005

EQ EQ EQ EQ EQ EQ EQ

500MG 500MG 500MG 500MG 500MG 500MG 500MG

BASE/VIAL BASE/VIAL BASE/VIAL BASE/VIAL BASE/VIAL BASE/VIAL BASE/VIAL

A065179 A065501 A065500 A065511 A065265 A065506 N050809

001 001 001 001 001 001 001

Dec Nov Jun Jun Jan Mar Dec

13, 09, 26, 26, 18, 24, 19,

2005 2009 2009 2009 2007 2009 2006

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

AZITHROMYCIN
INJECTABLE; INJECTION ZITHROMAX AP + PFIZER AZITHROMYCIN XX + TEVA PARENTERAL

3 - 46 (of 424)

EQ 500MG BASE/VIAL EQ 2.5GM BASE/VIAL

N050733 001 N050809 002

Jan 30, 1997 Dec 19, 2006

SOLUTION/DROPS; OPHTHALMIC
AZASITE
XX + INSPIRE 1% TABLET; ORAL AZITHROMYCIN APOTEX CORP AB AB AB MYLAN AB AB AB PLIVA AB AB AB SANDOZ AB AB AB TEVA AB AB AB WOCKHARDT AB AB AB ZITHROMAX PFIZER AB AB AB +

N050810 001

Apr 27, 2007

EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ

250MG 500MG 600MG 250MG 500MG 600MG 250MG 500MG 600MG 250MG 500MG 600MG 250MG 500MG 600MG 250MG 500MG 600MG

BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE

A065507 A065509 A065508 A065365 A065366 A065360 A065225 A065223 A065218 A065211 A065212 A065209 A065153 A065193 A065150 A065404 A065405 A065302

001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 003

Jul Jul Jul May May Jan Nov Nov Nov Nov Nov Nov Nov Nov Nov Feb Feb Feb

13, 13, 13, 30, 30, 08, 14, 14, 14, 14, 14, 14, 14, 14, 14, 11, 11, 11,

2011 2011 2011 2007 2007 2007 2005 2005 2005 2005 2005 2005 2005 2005 2005 2008 2008 2008

EQ 250MG BASE EQ 500MG BASE EQ 600MG BASE

N050711 001 N050784 001 N050730 001

Jul 18, 1996 May 24, 2002 Jun 12, 1996

AZTREONAM

FOR SOLUTION; INHALATION

CAYSTON
XX + GILEAD

75MG/VIAL

N050814 001

Feb 22, 2010

INJECTABLE; INJECTION AZACTAM AP + BRISTOL MYERS SQUIBB 1GM/VIAL AP + 2GM/VIAL AZTREONAM APP PHARMS AP 1GM/VIAL AP 2GM/VIAL BEDFORD AP 1GM/VIAL AP 2GM/VIAL AZACTAM IN PLASTIC CONTAINER XX + BRISTOL MYERS SQUIBB 20MG/ML 40MG/ML XX + AZTREONAM APP PHARMS 500MG/VIAL XX

N050580 002 N050580 003 A065439 A065439 A065286 A065286 002 003 001 002

Dec 31, 1986 Dec 31, 1986 Jun Jun Mar Mar 18, 18, 23, 23, 2010 2010 2011 2011

N050632 002 N050632 001 A065439 001

May 24, 1989 May 24, 1989 Jun 18, 2010

BACITRACIN
INJECTABLE; INJECTION BACIIM X GEN PHARMS AP BACITRACIN APP PHARMS AP

50,000 UNITS/VIAL 50,000 UNITS/VIAL

A064153 001 A065116 001

May 09, 1997 Dec 03, 2002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

BACITRACIN
INJECTABLE; INJECTION BACITRACIN AP + PHARMACIA AND UPJOHN SAGENT STRIDES AP BACITRACIN

PHARMACIA AND UPJOHN XX OINTMENT; OPHTHALMIC

BACITRACIN

XX + FERA PHARMS

3 - 47 (of 424)

50,000 UNITS/VIAL 50,000 UNITS/VIAL 10,000 UNITS/VIAL

A060733 002 A090211 001 A060733 001

May 11, 2010

500 UNITS/GM

A061212 001

POWDER; FOR RX COMPOUNDING

BACI-RX

X GEN PHARMS 5,000,000 UNITS/BOT XX

A061580 001

BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

OINTMENT; OPHTHALMIC

NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE

400 UNITS/GM;1%;EQ 3.5MG A064068 001 XX + BAUSCH AND LOMB BASE/GM;10,000 UNITS/GM OINTMENT; TOPICAL

CORTISPORIN

XX + MONARCH PHARMS

Oct 30, 1995

400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM

N050168 002

May 04, 1984

BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

OINTMENT; OPHTHALMIC NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC AKORN AT 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM AT + BAUSCH AND LOMB 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM FERA PHARMS AT 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM

A065088 001 A064064 001 A060764 002

Feb 06, 2004 Oct 30, 1995

BACITRACIN ZINC; POLYMYXIN B SULFATE

OINTMENT; OPHTHALMIC BACITRACIN ZINC AND POLYMYXIN B SULFATE AKORN AT 500 UNITS/GM;10,000 UNITS/GM AT + BAUSCH AND LOMB 500 UNITS/GM;10,000 UNITS/GM FERA PHARMS AT 500 UNITS/GM;10,000 UNITS/GM

A064028 001 A064046 001 A065022 001

Jan 30, 1995 Jan 26, 1995 Feb 27, 2002

BACITRACIN; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

OINTMENT; OPHTHALMIC BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE 400 UNITS/GM;1%;EQ 3.5MG XX + FERA PHARMS BASE/GM;10,000 UNITS/GM

A062166 002

BACLOFEN
INJECTABLE; INTRATHECAL GABLOFEN CNS THERAPS INC AP AP AP LIORESAL AP + MEDTRONIC AP + AP + TABLET; ORAL BACLOFEN CARACO AB

0.05MG/ML 0.5MG/ML 2MG/ML 0.05MG/ML 0.5MG/ML 2MG/ML

N022462 001 N022462 002 N022462 003 N020075 003 N020075 001 N020075 002

Nov 19, 2010 Nov 19, 2010 Nov 19, 2010 Nov 07, 1996 Jun 17, 1992 Jun 17, 1992

10MG

A077984 001

Aug 14, 2006

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

BACLOFEN
TABLET; ORAL BACLOFEN CARACO AB IMPAX LABS AB AB IVAX SUB TEVA PHARMS AB AB + LANNETT AB AB MATRIX LABS LTD AB AB MYLAN AB AB NORTHSTAR HLTHCARE AB AB PROSAM LABS AB AB USL PHARMA AB AB VINTAGE PHARMS AB AB WATSON LABS AB AB

3 - 48 (of 424)

20MG 10MG 20MG 10MG 20MG 10MG 20MG 10MG 20MG 10MG 20MG 10MG 20MG 10MG 20MG 10MG 20MG 10MG 20MG 10MG 20MG

A077862 A078146 A077971 A072234 A072235 A078220 A077241 A090334 A090334 A077181 A077121 A078504 A078401 A077089 A077088 A074584 A074584 A077156 A077068 A072824 A072825

002 001 002 001 001 001 001 001 002 001 002 001 001 001 001 001 002 001 001 001 001

Aug Oct Oct Jul Jul Jul Dec Feb Feb Jul Jul Sep Sep Oct Oct Aug Aug Aug Aug Sep Sep

14, 26, 26, 21, 21, 06, 20, 18, 18, 29, 29, 18, 18, 31, 31, 19, 19, 30, 30, 18, 18,

2006 2007 2007 1988 1988 2007 2005 2010 2010 2005 2005 2009 2009 2007 2007 1996 1996 2005 2005 1991 1991

BALSALAZIDE DISODIUM
CAPSULE; ORAL BALSALAZIDE DISODIUM APOTEX INC MYLAN ROXANE COLAZAL + SALIX PHARMS

AB AB AB AB

750MG 750MG 750MG 750MG

A077883 001 A077807 001 A077806 001 N020610 001

Dec 28, 2007 Dec 28, 2007 Dec 28, 2007 Jul 18, 2000

BECLOMETHASONE DIPROPIONATE
AEROSOL, METERED; INHALATION

QVAR 40

0.04MG/INH XX + TEVA BRANDED PHARM QVAR 80

0.08MG/INH XX + TEVA BRANDED PHARM

N020911 002 N020911 001

Sep 15, 2000

Sep 15, 2000

BECLOMETHASONE DIPROPIONATE MONOHYDRATE

SPRAY, METERED; NASAL

BECONASE AQ

XX + GLAXOSMITHKLINE

EQ 0.042MG DIPROP/SPRAY

N019389 001

Jul 27, 1987

BENAZEPRIL HYDROCHLORIDE
TABLET; ORAL BENAZEPRIL HYDROCHLORIDE APOTEX INC 5MG 10MG 20MG 40MG AUROBINDO PHARMA 10MG 20MG 40MG BIOKEY 5MG 10MG 20MG 40MG

AB AB AB AB AB AB AB AB AB AB AB

A077128 A077128 A077128 A077128 A078212 A078212 A078212 A076820 A076820 A076820 A076820

001 002 003 004 001 002 003 001 002 003 004

Mar Mar Mar Mar May May May Feb Feb Feb Feb

08, 08, 08, 08, 22, 22, 22, 03, 03, 03, 03,

2006 2006 2006 2006 2008 2008 2008 2006 2006 2006 2006

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

BENAZEPRIL HYDROCHLORIDE
TABLET; ORAL BENAZEPRIL HYDROCHLORIDE IVAX SUB TEVA PHARMS 5MG AB AB 10MG AB 20MG AB 40MG MYLAN AB 5MG AB 10MG AB 20MG AB 40MG PRINSTON INC AB 5MG AB 10MG AB 20MG AB 40MG RANBAXY AB 5MG AB 10MG AB 20MG AB 40MG SANDOZ AB 5MG AB 10MG AB 20MG AB 40MG TEVA AB 5MG AB 10MG AB 20MG AB 40MG WATSON LABS FLORIDA AB 5MG AB 10MG AB 20MG AB 40MG ZYDUS PHARMS USA AB 5MG AB 10MG AB 20MG AB 40MG LOTENSIN NOVARTIS AB 5MG AB 10MG AB 20MG AB + 40MG

3 - 49 (of 424)

A076333 A076333 A076333 A076333 A076430 A076430 A076430 A076430 A076118 A076118 A076118 A076118 A076344 A076344 A076344 A076344 A076402 A076402 A076402 A076402 A076211 A076211 A076211 A076211 A076267 A076267 A076267 A076267 A078848 A078848 A078848 A078848 N019851 N019851 N019851 N019851

001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004

Feb Feb Feb Feb Feb Feb Feb Feb Feb Feb Feb Feb Feb Feb Feb Feb Feb Feb Feb Feb Feb Feb Feb Feb Feb Feb Feb Feb May May May May Jun Jun Jun Jun

11, 11, 11, 11, 11, 11, 11, 11, 11, 11, 11, 11, 11, 11, 11, 11, 11, 11, 11, 11, 11, 11, 11, 11, 11, 11, 11, 11, 23, 23, 23, 23, 25, 25, 25, 25,

2004 2004 2004 2004 2004 2004 2004 2004 2004 2004 2004 2004 2004 2004 2004 2004 2004 2004 2004 2004 2004 2004 2004 2004 2004 2004 2004 2004 2008 2008 2008 2008 1991 1991 1991 1991

BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

TABLET; ORAL BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE IVAX SUB TEVA PHARMS 5MG;6.25MG AB AB 10MG;12.5MG AB 20MG;12.5MG AB 20MG;25MG MYLAN AB 5MG;6.25MG AB 5MG;6.25MG AB 10MG;12.5MG AB 10MG;12.5MG AB 20MG;12.5MG AB 20MG;12.5MG AB 20MG;25MG AB 20MG;25MG RANBAXY AB 5MG;6.25MG AB 10MG;12.5MG AB 20MG;12.5MG AB 20MG;25MG

A076348 A076348 A076348 A076348 A076612 A076688 A076612 A076688 A076612 A076688 A076612 A076688 A077483 A077483 A077483 A077483

001 002 003 004 001 001 002 002 003 003 004 004 001 002 003 004

Feb Feb Feb Feb Feb Feb Feb Feb Feb Feb Feb Feb Sep Sep Sep Sep

11, 11, 11, 11, 11, 11, 11, 11, 11, 11, 11, 11, 08, 08, 08, 08,

2004 2004 2004 2004 2004 2004 2004 2004 2004 2004 2004 2004 2005 2005 2005 2005

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
TABLET; ORAL BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE SANDOZ AB 5MG;6.25MG AB 10MG;12.5MG AB 20MG;12.5MG AB 20MG;25MG WATSON LABS FLORIDA AB 5MG;6.25MG AB 10MG;12.5MG AB 20MG;12.5MG AB 20MG;25MG LOTENSIN HCT NOVARTIS AB 5MG;6.25MG AB 10MG;12.5MG AB 20MG;12.5MG AB + 20MG;25MG

3 - 50 (of 424)

A076631 A076631 A076631 A076631 A076342 A076342 A076342 A076342 N020033 N020033 N020033 N020033

001 002 003 004 001 002 003 004 001 002 004 003

Feb Feb Feb Feb Feb Feb Feb Feb May May May May

11, 11, 11, 11, 11, 11, 11, 11, 19, 19, 19, 19,

2004 2004 2004 2004 2004 2004 2004 2004 1992 1992 1992 1992

BENDAMUSTINE HYDROCHLORIDE
POWDER; IV (INFUSION)
TREANDA
XX + CEPHALON XX +

25MG/VIAL 100MG/VIAL

N022249 002 N022249 001

May 01, 2009 Mar 20, 2008

BENDROFLUMETHIAZIDE; NADOLOL
TABLET; ORAL CORZIDE KING PHARMS 5MG;40MG + 5MG;80MG NADOLOL AND BENDROFLUMETHAZIDE MYLAN 5MG;40MG 5MG;80MG NADOLOL AND BENDROFLUMETHIAZIDE IMPAX LABS 5MG;40MG 5MG;80MG

AB AB AB AB AB AB

N018647 001 N018647 002 A078688 001 A078688 002 A077833 001 A077833 002

May 25, 1983 May 25, 1983 Feb 15, 2008 Feb 15, 2008 Mar 30, 2007 Mar 30, 2007

BENZONATATE
CAPSULE; ORAL BENZONATATE BANNER PHARMACAPS AA AA MIKART AA AA NESHER PHARMS AA AA ORIT LABS LLC AA AA SUN PHARM INDS INC AA AA THE PHARMA NETWORK AA AA ZYDUS PHARMS USA AA AA TESSALON AA + FOREST LABS AA + BENZONATATE MIKART XX

100MG 200MG 100MG 200MG 100MG 200MG 100MG 200MG 100MG 200MG 100MG 200MG 100MG 200MG 100MG 200MG 150MG

A081297 A081297 A040851 A040851 A040795 A040795 A040682 A040682 A040587 A040587 A040627 A040749 A040597 A040597

001 002 001 003 001 002 001 002 001 002 001 001 001 002

Jan Oct Nov Nov Oct Oct Jul Jul Mar Mar Mar Jul Jun Jun

29, 30, 09, 09, 31, 31, 30, 30, 19, 19, 30, 25, 08, 08,

1993 2007 2009 2009 2007 2007 2007 2007 2008 2008 2007 2007 2007 2007

N011210 001 N011210 003 A040851 002

Jun 25, 1999 Nov 09, 2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
GEL; TOPICAL BENZACLIN SANOFI AVENTIS US 5%;EQ 1% BASE CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE DOW PHARM SCIENCES 5%;EQ 1% BASE BENZACLIN + SANOFI AVENTIS US 5%;EQ 1% BASE DUAC + STIEFEL 5%;EQ 1% BASE ACANYA + DOW PHARM SCI 2.5%;1.2%

3 - 51 (of 424)

AB AB BT BT XX

N050756 001 A065443 001 N050756 002 N050741 001 N050819 001

Dec 21, 2000 Aug 11, 2009 Apr 20, 2007 Aug 26, 2002 Oct 23, 2008

BENZOYL PEROXIDE; ERYTHROMYCIN

GEL; TOPICAL BENZAMYCIN AB + SANOFI AVENTIS US 5%;3% ERYTHROMYCIN AND BENZOYL PEROXIDE TOLMAR AB 5%;3% BENZAMYCIN PAK 5%;3% XX + SANOFI AVENTIS US

N050557 001 A065112 001 N050769 001

Oct 26, 1984 Mar 29, 2004 Nov 27, 2000

BENZPHETAMINE HYDROCHLORIDE
TABLET; ORAL BENZPHETAMINE HYDROCHLORIDE COREPHARMA 50MG IMPAX LABS 50MG KVK TECH 50MG MALLINCKRODT INC 50MG MIKART 25MG 50MG PADDOCK 50MG TEDOR PHARM 50MG DIDREX + PHARMACIA AND UPJOHN 50MG

AA AA AA AA AA AA AA AA AA

A040714 A040845 A090968 A040773 A090473 A090473 A040578 A040747

001 001 001 001 001 002 001 001

Oct Nov Jul Apr Sep Sep Apr Mar

29, 18, 20, 25, 15, 15, 17, 30,

2007 2008 2010 2007 2010 2010 2006 2007

N012427 002

BENZTROPINE MESYLATE
INJECTABLE; INJECTION BENZTROPINE MESYLATE HIKMA FARMACEUTICA LUITPOLD NEXUS PHARMS COGENTIN + LUNDBECK INC

AP AP AP AP

1MG/ML 1MG/ML 1MG/ML 1MG/ML

A090287 001 A091152 001 A090233 001 N012015 001

Aug 31, 2009 Mar 29, 2010 Jul 28, 2009

TABLET; ORAL BENZTROPINE MESYLATE COREPHARMA AA AA AA INVAGEN PHARMS AA AA AA AA + LANNETT AA + AA + PLIVA AA AA AA USL PHARMA AA AA

0.5MG 1MG 2MG 0.5MG 1MG 2MG 0.5MG 1MG 2MG 0.5MG 1MG 2MG 0.5MG 1MG

A072264 A072265 A072266 A090294 A090294 A090294 A088877 A088894 A088895 A089058 A089059 A089060 A040103 A040103

001 001 001 001 002 003 001 001 001 001 001 001 001 002

Feb Feb Feb Mar Mar Mar Apr Apr Apr Aug Aug Aug Dec Dec

27, 27, 27, 29, 29, 29, 11, 11, 11, 10, 10, 10, 12, 12,

1989 1989 1989 2010 2010 2010 1985 1985 1985 1988 1988 1988 1996 1996

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

BENZTROPINE MESYLATE
TABLET; ORAL BENZTROPINE MESYLATE USL PHARMA AA VINTAGE AA AA AA

3 - 52 (of 424)

2MG 0.5MG 1MG 2MG

A040103 A040738 A040742 A040715

003 001 001 003

Dec Aug Aug Aug

12, 27, 27, 27,

1996 2007 2007 2007

BENZYL ALCOHOL
LOTION; TOPICAL
ULESFIA
XX + SHIONOGI INC

5%

N022129 001

Apr 09, 2009

BENZYLPENICILLOYL POLYLYSINE
INJECTABLE; INJECTION
PRE-PEN
XX + ALLERQUEST

60UMOLAR

N050114 001

BEPOTASTINE BESILATE
SOLUTION/DROPS; OPHTHALMIC
BEPREVE
1.5% XX + ISTA PHARMS

N022288 001

Sep 08, 2009

BERACTANT
SUSPENSION; INTRATRACHEAL
SURVANTA
25MG/ML XX + ROSS LABS

N020032 001

Jul 01, 1991

BESIFLOXACIN HYDROCHLORIDE
SUSPENSION/DROPS; OPHTHALMIC
BESIVANCE
EQ 0.6% BASE XX + BAUSCH AND LOMB

N022308 001

May 28, 2009

BETAINE HYDROCHLORIDE
FOR SOLUTION; ORAL
CYSTADANE
XX + RARE DIS THERAP

1GM/SCOOPFUL

N020576 001

Oct 25, 1996

BETAMETHASONE
SYRUP; ORAL
CELESTONE
XX + SCHERING

0.6MG/5ML

N014215 002

BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE

INJECTABLE; INJECTION BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE LUITPOLD AB 3MG/ML;EQ 3MG BASE/ML CELESTONE SOLUSPAN AB + SCHERING 3MG/ML;EQ 3MG BASE/ML

A090747 001 N014602 001

Jul 31, 2009

BETAMETHASONE DIPROPIONATE
CREAM; TOPICAL BETAMETHASONE DIPROPIONATE ACTAVIS MID ATLANTIC EQ 0.05% BASE AB AB + FOUGERA EQ 0.05% BASE TARO AB EQ 0.05% BASE

A070885 001 N019137 001 A073552 001

Feb 03, 1987 Jun 26, 1984 Apr 30, 1992

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

BETAMETHASONE DIPROPIONATE
CREAM, AUGMENTED; TOPICAL BETAMETHASONE DIPROPIONATE ALTANA EQ GLENMARK GENERICS EQ PERRIGO NEW YORK EQ TARO EQ TOLMAR EQ DIPROLENE AF + SCHERING EQ

3 - 53 (of 424)

AB AB AB AB AB AB

0.05% 0.05% 0.05% 0.05% 0.05%

BASE BASE BASE BASE BASE

A076215 A078930 A076592 A076543 A076603

001 001 001 001 001

Dec Sep Dec Dec Jan

09, 23, 09, 09, 23,

2003 2008 2003 2003 2004

0.05% BASE

N019555 001

Apr 27, 1987

GEL, AUGMENTED; TOPICAL BETAMETHASONE DIPROPIONATE AB + ALTANA EQ 0.05% BASE TARO AB EQ 0.05% BASE LOTION; TOPICAL BETAMETHASONE DIPROPIONATE ACTAVIS MID ATLANTIC EQ 0.05% BASE + FOUGERA EQ 0.05% BASE PERRIGO NEW YORK EQ 0.05% BASE TEVA EQ 0.05% BASE

A075276 001 A076508 001

May 13, 2003 Dec 02, 2003

AB AB AB AB

A070281 A070275 A072538 A071467

001 001 001 001

Jul Aug Jan Aug

31, 12, 31, 10,

1985 1985 1990 1987

LOTION, AUGMENTED; TOPICAL BETAMETHASONE DIPROPIONATE ALTANA AB EQ 0.05% BASE TARO AB EQ 0.05% BASE DIPROLENE AB + SCHERING EQ 0.05% BASE OINTMENT; TOPICAL BETAMETHASONE DIPROPIONATE ACTAVIS MID ATLANTIC EQ 0.05% BASE AB AB + FOUGERA EQ 0.05% BASE TARO AB EQ 0.05% BASE OINTMENT, AUGMENTED; TOPICAL BETAMETHASONE DIPROPIONATE ACTAVIS MID ATLANTIC EQ ALTANA EQ TARO EQ DIPROLENE + SCHERING EQ

A077111 001 A077477 001 N019716 001

May 21, 2007 May 21, 2007 Aug 01, 1988

A071012 001 N019141 001 A074271 001

Feb 03, 1987 Sep 04, 1984 Sep 15, 1994

AB AB AB AB

0.05% BASE 0.05% BASE 0.05% BASE 0.05% BASE

A074304 001 A075373 001 A076753 001 N018741 001

Aug 31, 1995 Jun 22, 1999 Oct 12, 2004 Jul 27, 1983

BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE

OINTMENT; TOPICAL

TACLONEX

XX + LEO PHARM SUSPENSION; TOPICAL

TACLONEX SCALP

XX + LEO PHARM PRODS

0.064%;0.005%

N021852 001

Jan 09, 2006

0.064%;0.005%

N022185 001

May 09, 2008

BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE

CREAM; TOPICAL CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE ACTAVIS MID ATLANTIC EQ 0.05% BASE;1% ALTANA EQ 0.05% BASE;1% TARO EQ 0.05% BASE;1% LOTRISONE + SCHERING EQ 0.05% BASE;1%

AB AB AB AB

A076002 001 A075502 001 A075673 001 N018827 001

Aug 02, 2002 Jun 05, 2001 May 29, 2001 Jul 10, 1984

LOTION; TOPICAL CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE ALTANA PHARMA AB EQ 0.05% BASE;1%

A076516 001

Jun 16, 2005

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE
LOTION; TOPICAL CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE TARO AB EQ 0.05% BASE;1% LOTRISONE AB + SCHERING PLOUGH RES EQ 0.05% BASE;1%

3 - 54 (of 424)

A076493 001 N020010 001

Jul 28, 2004 Dec 08, 2000

BETAMETHASONE VALERATE
AEROSOL, FOAM; TOPICAL
LUXIQ
XX + CONNECTICS CREAM; TOPICAL BETAMETHASONE VALERATE + FOUGERA BETA-VAL TEVA DERMABET TARO VALNAC ACTAVIS MID ATLANTIC

EQ 0.12% BASE

N020934 001

Feb 28, 1999

AB AB AB AB

EQ 0.1% BASE EQ 0.1% BASE EQ 0.1% BASE EQ 0.1% BASE

N018861 001 N018642 001 A072041 001 A070050 001

Aug 31, 1983 Mar 24, 1983 Jan 06, 1988 Oct 10, 1984

LOTION; TOPICAL BETAMETHASONE VALERATE AB + FOUGERA STI PHARMA LLC AB BETA-VAL TEVA AB OINTMENT; TOPICAL BETAMETHASONE VALERATE ACTAVIS MID ATLANTIC AB AB + FOUGERA

EQ 0.1% BASE EQ 0.1% BASE EQ 0.1% BASE

N018866 001 A070052 001 A070072 001

Aug 31, 1983 Jul 31, 1985 Jun 27, 1985

EQ 0.1% BASE EQ 0.1% BASE

A070051 001 N018865 001

Oct 10, 1984 Aug 31, 1983

BETAXOLOL HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC BETAXOLOL HYDROCHLORIDE AKORN EQ BAUSCH AND LOMB EQ NOVEX EQ WOCKHARDT EQ BETOPTIC + ALCON EQ

AT AT AT AT AT

0.5% 0.5% 0.5% 0.5%

BASE BASE BASE BASE

A075386 A075630 A075446 A078694

001 001 001 001

Jun Apr Sep Nov

30, 12, 28, 16,

2000 2001 2000 2009

0.5% BASE

N019270 001

Aug 30, 1985

SUSPENSION/DROPS; OPHTHALMIC
BETOPTIC S
EQ 0.25% BASE XX + ALCON TABLET; ORAL BETAXOLOL HYDROCHLORIDE EPIC PHARMA AB 10MG AB + 20MG KVK TECH AB 10MG AB 20MG

N019845 001

Dec 29, 1989

A075541 A075541 A078962 A078962

001 002 001 002

Oct Oct Jun Jun

22, 22, 27, 27,

1999 1999 2008 2008

BETHANECHOL CHLORIDE
TABLET; ORAL BETHANECHOL CHLORIDE AMNEAL PHARM AA AA AA AA EMCURE USA AA AA

5MG 10MG 25MG 50MG 5MG 10MG

A040855 A040855 A040855 A040855 A091256 A091256

001 002 003 004 001 002

Nov Nov Nov Nov May May

21, 21, 21, 21, 04, 04,

2007 2007 2007 2007 2010 2010

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

BETHANECHOL CHLORIDE
TABLET; ORAL BETHANECHOL CHLORIDE EMCURE USA AA AA IMPAX LABS AA AA AA AA LANNETT AA AA AA AA PHARMAX AA AA AA AA SUN PHARM INDS INC AA AA AA AA UPSHER SMITH AA AA AA AA WOCKHARDT AA AA AA AA DUVOID WELLSPRING PHARM AA AA AA URECHOLINE AA + ODYSSEY PHARMS AA + AA + AA +

3 - 55 (of 424)

25MG 50MG 5MG 10MG 25MG 50MG 5MG 10MG 25MG 50MG 5MG 10MG 25MG 50MG 5MG 10MG 25MG 50MG 5MG 10MG 25MG 50MG 5MG 10MG 25MG 50MG 10MG 25MG 50MG 5MG 10MG 25MG 50MG

A091256 A091256 A040739 A040741 A040740 A040721 A040703 A040704 A040678 A040677 A040725 A040726 A040727 A040728 A040897 A040897 A040897 A040897 A040633 A040634 A040635 A040636 A040532 A040533 A040534 A040518

003 004 001 001 001 004 001 001 003 001 001 001 001 001 001 002 003 004 001 001 001 001 001 001 001 001

May May Nov Nov Nov Nov Mar Mar Mar Mar Oct Oct Oct Oct Apr Apr Apr Apr Jun Jun Jun Jun Sep Sep Sep Sep

04, 04, 01, 01, 01, 01, 27, 27, 27, 27, 26, 26, 26, 26, 22, 22, 22, 22, 01, 01, 01, 01, 29, 29, 29, 29,

2010 2010 2006 2006 2006 2006 2008 2008 2008 2008 2007 2007 2007 2007 2009 2009 2009 2009 2005 2005 2005 2005 2003 2003 2003 2003

A086262 001 A086263 001 A085882 003 A089095 A088440 A088441 A089096 001 001 001 001 Dec May May Dec 19, 29, 29, 19, 1985 1984 1984 1985

BEXAROTENE
CAPSULE; ORAL

TARGRETIN

XX + EISAI INC GEL; TOPICAL

TARGRETIN

XX + EISAI INC

75MG

N021055 001

Dec 29, 1999

1%

N021056 001

Jun 28, 2000

BICALUTAMIDE
TABLET; ORAL BICALUTAMIDE ACCORD HLTHCARE INC ACTAVIS TOTOWA FRESENIUS KABI ONCOL KUDCO IRELAND MYLAN ROXANE SANDOZ SUN PHARMA GLOBAL SYNTHON PHARMS TEVA

AB AB AB AB AB AB AB AB AB AB

50MG 50MG 50MG 50MG 50MG 50MG 50MG 50MG 50MG 50MG

A078917 A078634 A079045 A077995 A079185 A078285 A078575 A079110 A077973 A076932

001 001 001 001 001 001 001 001 001 001

Jul Aug May Jul Jul Mar Jul Jul Jul Jul

06, 28, 13, 06, 06, 24, 06, 06, 06, 06,

2009 2009 2010 2009 2009 2011 2009 2009 2009 2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

BICALUTAMIDE
TABLET; ORAL BICALUTAMIDE ZYDUS PHARMS USA INC AB CASODEX AB + ASTRAZENECA

3 - 56 (of 424)

50MG 50MG

A079089 001 N020498 001

Jul 06, 2009 Oct 04, 1995

BIMATOPROST
SOLUTION/DROPS; OPHTHALMIC

LUMIGAN

0.01% XX + ALLERGAN 0.03% XX + SOLUTION/DROPS; TOPICAL
LATISSE
XX + ALLERGAN

N022184 001 N021275 001

Aug 31, 2010 Mar 16, 2001

0.03%

N022369 001

Dec 24, 2008

BIPERIDEN HYDROCHLORIDE

TABLET; ORAL

AKINETON
XX + ABBOTT

2MG

N012003 001

BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE

FOR SOLUTION; TABLET, DELAYED RELEASE; ORAL

HALFLYTELY
5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM XX + BRAINTREE ;N/A,5.6GM

N021551 003

Jul 16, 2010

BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE

CAPSULE; ORAL

PYLERA
XX + APTALIS PHARMA US

140MG;125MG;125MG

N050786 001

Sep 28, 2006

BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE

TABLET, CHEWABLE, TABLET, CAPSULE; ORAL

HELIDAC
262.4MG,N/A,N/A;N/A,250MG,N/A;N/A,N/A,5 XX + PROMETHEUS LABS 00MG

N050719 001

Aug 15, 1996

BISOPROLOL FUMARATE
TABLET; ORAL BISOPROLOL FUMARATE AUROBINDO PHARMA AB AB MYLAN AB AB SANDOZ AB AB TEVA PHARMS AB AB UNICHEM PHARMS (USA) AB AB ZEBETA DURAMED PHARMS BARR AB AB +

5MG 10MG 5MG 10MG 5MG 10MG 5MG 10MG 5MG 10MG 5MG 10MG

A077910 A077910 A075831 A075831 A075643 A075643 A075644 A075644 A078635 A078635

001 002 001 002 001 002 001 002 001 002

Dec Dec Dec Dec Nov Nov Jun Jun Aug Aug

27, 27, 14, 14, 16, 16, 26, 26, 18, 18,

2006 2006 2005 2005 2000 2000 2001 2001 2009 2009

N019982 002 N019982 001

Jul 31, 1992 Jul 31, 1992

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
TABLET; ORAL BISOPROLOL FUMARATE AND MYLAN AB AB AB SANDOZ AB AB AB UNICHEM AB AB AB WATSON LABS AB AB AB ZIAC DURAMED PHARMS BARR AB AB AB + HYDROCHLOROTHIAZIDE 2.5MG;6.25MG 5MG;6.25MG 10MG;6.25MG 2.5MG;6.25MG 5MG;6.25MG 10MG;6.25MG 2.5MG;6.25MG 5MG;6.25MG 10MG;6.25MG 2.5MG;6.25MG 5MG;6.25MG 10MG;6.25MG 2.5MG;6.25MG 5MG;6.25MG 10MG;6.25MG

3 - 57 (of 424)

A075768 A075768 A075768 A075579 A075579 A075579 A079106 A079106 A079106 A075469 A075469 A075469

001 002 003 001 002 003 001 002 003 001 002 003

Sep Sep Sep Sep Sep Sep Jul Jul Jul Sep Sep Sep

25, 25, 25, 25, 25, 25, 28, 28, 28, 25, 25, 25,

2000 2000 2000 2000 2000 2000 2010 2010 2010 2000 2000 2000

N020186 003 N020186 001 N020186 002

Mar 26, 1993 Mar 26, 1993 Mar 26, 1993

BIVALIRUDIN
INJECTABLE; INTRAVENOUS
ANGIOMAX
XX + MEDICINES CO

250MG/VIAL

N020873 001

Dec 15, 2000

BLEOMYCIN SULFATE
INJECTABLE; INJECTION BLEOMYCIN SULFATE AP + APP PHARMS AP + BEDFORD AP AP HOSPIRA AP AP PHARMACHEMIE BV AP TEVA PARENTERAL AP AP

EQ EQ EQ EQ EQ EQ EQ EQ EQ

15 30 15 30 15 30 15 15 30

UNITS UNITS UNITS UNITS UNITS UNITS UNITS UNITS UNITS

BASE/VIAL BASE/VIAL BASE/VIAL BASE/VIAL BASE/VIAL BASE/VIAL BASE/VIAL BASE/VIAL BASE/VIAL

A065185 A065185 A065042 A065042 A065031 A065031 A065201 A065033 A065033

001 002 002 001 001 002 001 001 002

Jan Jan Oct Oct Mar Mar Dec Jun Jun

28, 28, 17, 17, 10, 10, 13, 27, 27,

2008 2008 2001 2001 2000 2000 2007 2000 2000

BOCEPREVIR
CAPSULE; ORAL
VICTRELIS
XX + SCHERING

200MG

N202258 001

May 13, 2011

BORTEZOMIB
INJECTABLE; INTRAVENOUS
VELCADE
XX + MILLENNIUM PHARMS

3.5MG/VIAL

N021602 001

May 13, 2003

BOSENTAN
TABLET; ORAL TRACLEER ACTELION XX XX +

62.5MG 125MG

N021290 001 N021290 002

Nov 20, 2001 Nov 20, 2001

BRETYLIUM TOSYLATE
INJECTABLE; INJECTION
BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER
100MG/100ML XX + B BRAUN 200MG/100ML XX +

N019121 001 N019121 002

Apr 29, 1986 Apr 29, 1986

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

BRETYLIUM TOSYLATE
INJECTABLE; INJECTION
BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER
400MG/100ML XX + B BRAUN

3 - 58 (of 424)

N019121 003

Apr 29, 1986

BRIMONIDINE TARTRATE
SOLUTION/DROPS; OPHTHALMIC ALPHAGAN P + ALLERGAN 0.15% BRIMONIDINE TARTRATE AKORN 0.2% ALCON PHARMS LTD 0.15% 0.2% + BAUSCH AND LOMB 0.2% SANDOZ 0.2% ALPHAGAN P + ALLERGAN 0.1%

AT AT AT AT AT AT XX

N021262 001 A076439 N021764 A076254 A076260 A078075 001 001 001 001 001

Mar 16, 2001 Mar May Sep May Jan 14, 22, 16, 28, 30, 2006 2006 2003 2003 2008

N021770 001

Aug 19, 2005

BRIMONIDINE TARTRATE; TIMOLOL MALEATE

SOLUTION/DROPS; OPHTHALMIC
COMBIGAN
0.2%;0.5% XX + ALLERGAN

N021398 001

Oct 30, 2007

BRINZOLAMIDE
SUSPENSION/DROPS; OPHTHALMIC
AZOPT
XX + ALCON PHARMS LTD 1%

N020816 001

Apr 01, 1998

BROMFENAC SODIUM
SOLUTION/DROPS; OPHTHALMIC
BROMDAY
0.09% XX + ISTA PHARMS INC BROMFENAC SODIUM COASTAL PHARMS 0.09% XX

N021664 002 A201211 001

Oct 16, 2010 May 11, 2011

BROMOCRIPTINE MESYLATE
CAPSULE; ORAL BROMOCRIPTINE MESYLATE MYLAN AB ZYDUS PHARMS USA INC AB PARLODEL AB + NOVARTIS TABLET; ORAL BROMOCRIPTINE MESYLATE LEK PHARMS MYLAN PADDOCK LLC PARLODEL + NOVARTIS CYCLOSET + VEROSCIENCE

EQ 5MG BASE EQ 5MG BASE EQ 5MG BASE

A077226 001 A078899 001 N017962 002

Apr 04, 2005 Jul 30, 2008 Mar 01, 1982

AB AB AB AB XX

EQ 2.5MG BASE EQ 2.5MG BASE EQ 2.5MG BASE EQ 2.5MG BASE EQ 0.8MG BASE

A074631 001 A076962 001 A077646 001 N017962 001 N020866 001

Jan 13, 1998 Sep 24, 2004 Oct 01, 2008

May 05, 2009

BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

SYRUP; ORAL

BROMFED-DM

XX + WOCKHARDT

2MG/5ML;10MG/5ML;30MG/5ML

A088811 001

Jun 07, 1985

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

BUDESONIDE
CAPSULE; ORAL BUDESONIDE MYLAN AB ENTOCORT EC AB + ASTRAZENECA

3 - 59 (of 424)

3MG 3MG

A090410 001 N021324 001

May 16, 2011 Oct 02, 2001

POWDER, METERED; INHALATION

PULMICORT

0.16MG/INH XX + ASTRAZENECA PULMICORT FLEXHALER ASTRAZENECA 0.08MG/INH XX 0.16MG/INH XX + SPRAY, METERED; NASAL

RHINOCORT

XX + ASTRAZENECA SUSPENSION; INHALATION BUDESONIDE APOTEX AN AN TEVA PARENTERAL AN AN PULMICORT RESPULES ASTRAZENECA AN AN PULMICORT RESPULES XX + ASTRAZENECA

N020441 002 N021949 001 N021949 002

Jun 24, 1997 Jul 12, 2006 Jul 12, 2006

0.032MG/INH

N020746 001

Oct 01, 1999

0.25MG/2ML 0.5MG/2ML 0.25MG/2ML 0.5MG/2ML 0.25MG/2ML 0.5MG/2ML 1MG/2ML

A078202 A078202 A077519 A077519

001 002 001 002

Mar Mar Nov Nov

30, 30, 18, 18,

2009 2009 2008 2008

N020929 001 N020929 002 N020929 003

Aug 08, 2000 Aug 08, 2000 Aug 08, 2000

BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE

SPRAY, METERED; INHALATION

SYMBICORT
0.08MG/INH;0.0045MG/INH XX + ASTRAZENECA 0.16MG/INH;0.0045MG/INH XX +

N021929 001 N021929 002

Jul 21, 2006 Jul 21, 2006

BUMETANIDE
INJECTABLE; INJECTION BUMETANIDE BAXTER HLTHCARE AP AP + BEDFORD HOSPIRA AP TABLET; ORAL BUMETANIDE IVAX SUB TEVA PHARMS AB AB AB SANDOZ AB AB AB +

0.25MG/ML 0.25MG/ML 0.25MG/ML

A079196 001 A074441 001 A074332 001

Apr 30, 2008 Jan 27, 1995 Oct 31, 1994

0.5MG 1MG 2MG 0.5MG 1MG 2MG

A074225 A074225 A074225 A074700 A074700 A074700

001 002 003 001 002 003

Apr Apr Apr Nov Nov Nov

24, 24, 24, 21, 21, 21,

1995 1995 1995 1996 1996 1996

BUPIVACAINE

INJECTABLE, LIPOSOMAL; INJECTION

EXPAREL
133MG/10ML (13.3MG/ML) XX + PACIRA PHARMS INC 266MG/20ML (13.3MG/ML) XX +

N022496 001 N022496 002

Oct 28, 2011 Oct 28, 2011

BUPIVACAINE HYDROCHLORIDE
INJECTABLE; INJECTION BUPIVACAINE HYDROCHLORIDE HOSPIRA AP 0.25% AP 0.25%

A070583 001 A070586 001

Feb 17, 1987 Mar 03, 1987

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

BUPIVACAINE HYDROCHLORIDE
INJECTABLE; INJECTION BUPIVACAINE HYDROCHLORIDE HOSPIRA 0.25% 0.25% 0.5% 0.5% 0.5% 0.5% 0.75% 0.75% 0.75% SAGENT STRIDES 0.25% 0.5% BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE INTL MEDICATED 0.25% 0.5% 0.75% SAGENT STRIDES 0.25% 0.5% 0.75% MARCAINE HYDROCHLORIDE + HOSPIRA 0.25% + 0.5% MARCAINE HYDROCHLORIDE PRESERVATIVE FREE + HOSPIRA 0.25% + 0.5% + 0.75% SENSORCAINE APP PHARMS 0.25% 0.25% 0.5% 0.5% 0.75% 0.75%

3 - 60 (of 424)

AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP

A070590 N018053 A070584 A070597 A070609 N018053 A070585 A070587 N018053 A091503 A091503 A076012 A076012 A076012 A091487 A091487 A091487

001 002 001 001 001 001 001 001 003 001 002 001 002 003 002 001 003

Feb 17, 1987 Feb 17, 1986 Mar 03, 1987 Mar 03, 1987 Mar 03, 1987 Mar 03, 1987 Oct 18, 2011 Oct 18, 2011 Jan Jan Jan Oct Oct Oct 09, 09, 09, 18, 18, 18, 2002 2002 2002 2011 2011 2011

N016964 001 N016964 006 N016964 012 N016964 005 N016964 009 A070552 N018304 A070553 N018304 A070554 N018304 001 001 001 002 001 003 May 21, 1986 May 21, 1986 May 21, 1986

INJECTABLE; SPINAL BUPIVACAINE HYDROCHLORIDE HOSPIRA 0.75% AP MARCAINE AP + HOSPIRA 0.75% SENSORCAINE APP PHARMS AP 0.75%

A071810 001 N018692 001 A071202 001

Dec 11, 1987 May 04, 1984 Apr 15, 1987

BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE

INJECTABLE; INJECTION BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE + HOSPIRA 0.5%;0.005MG/ML 0.5%;0.005MG/ML BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE + HOSPIRA 0.25%;0.005MG/ML 0.25%;0.005MG/ML

AP AP XX XX

A071168 001 A071170 001 A071165 001 A071167 001

Jun 16, 1988 Jun 16, 1988 Jun 16, 1988 Jun 16, 1988

BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

INJECTABLE; INJECTION BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE SEPTODONT AP 0.5%;0.0091MG/ML BUPIVACAINE HYDROCHLORIDE W/EPINEPHRINE AP + HOSPIRA 0.5%;0.0091MG/ML MARCAINE HYDROCHLORIDE W/ EPINEPHRINE AP + HOSPIRA 0.25%;0.0091MG/ML

A077250 001 N022046 001 N016964 004

Sep 27, 2006 Jul 13, 1983

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
INJECTABLE; INJECTION MARCAINE HYDROCHLORIDE W/ EPINEPHRINE + HOSPIRA 0.5%;0.0091MG/ML MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE + HOSPIRA 0.25%;0.0091MG/ML + 0.5%;0.0091MG/ML + 0.75%;0.0091MG/ML SENSORCAINE APP PHARMS 0.25%;0.0091MG/ML 0.25%;0.0091MG/ML 0.5%;0.0091MG/ML 0.5%;0.0091MG/ML 0.75%;0.0091MG/ML

3 - 61 (of 424)

AP AP AP AP AP AP AP AP AP

N016964 008 N016964 013 N016964 007 N016964 010 A070966 A070967 A070968 N018304 N018304 001 001 001 004 005 Oct Oct Oct Sep Sep 13, 13, 13, 02, 02, 1987 1987 1987 1983 1983

BUPRENORPHINE
FILM, EXTENDED RELEASE; TRANSDERMAL
BUTRANS
PURDUE PHARMA LP 5MCG/HR
XX 10MCG/HR
XX 20MCG/HR XX +

N021306 001 N021306 002 N021306 003

Jun 30, 2010 Jun 30, 2010 Jun 30, 2010

BUPRENORPHINE HYDROCHLORIDE
INJECTABLE; INJECTION BUPRENEX + RECKITT BENCKISER EQ 0.3MG BUPRENORPHINE HYDROCHLORIDE BEDFORD EQ 0.3MG HOSPIRA EQ 0.3MG LUITPOLD EQ 0.3MG TABLET; SUBLINGUAL BUPRENORPHINE HYDROCHLORIDE BARR EQ 2MG EQ 8MG ETHYPHARM EQ 2MG EQ 8MG ROXANE EQ 2MG EQ 8MG SUBUTEX RECKITT BENCKISER EQ 2MG + EQ 8MG

AP AP AP AP

BASE/ML BASE/ML BASE/ML BASE/ML

N018401 001 A076931 001 A074137 001 A078331 001 Mar 02, 2005 Jun 03, 1996 Mar 27, 2007

AB AB AB AB AB AB AB AB

BASE BASE BASE BASE BASE BASE BASE BASE

A090360 A090360 A090622 A090622 A078633 A078633

001 002 001 002 001 002

May May Sep Sep Oct Oct

07, 07, 24, 24, 08, 08,

2010 2010 2010 2010 2009 2009

N020732 002 N020732 003

Oct 08, 2002 Oct 08, 2002

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

TABLET; SUBLINGUAL SUBOXONE RECKITT BENCKISER XX XX +

2MG;0.5MG 8MG;2MG

N020733 001 N020733 002

Oct 08, 2002 Oct 08, 2002

BUPRENORPHINE; NALOXONE
FILM; SUBLINGUAL SUBOXONE RECKITT BENCKISER XX XX +

2MG;0.5MG 8MG;2MG

N022410 001 N022410 002

Aug 30, 2010 Aug 30, 2010

BUPROPION HYDROBROMIDE
TABLET, EXTENDED RELEASE; ORAL APLENZIN VALEANT INTL 174MG XX 348MG XX +

N022108 001 N022108 002

Apr 23, 2008 Apr 23, 2008

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

BUPROPION HYDROBROMIDE
TABLET, EXTENDED RELEASE; ORAL APLENZIN VALEANT INTL 522MG XX

3 - 62 (of 424)

N022108 003

Apr 23, 2008

BUPROPION HYDROCHLORIDE
TABLET; ORAL BUPROPION HYDROCHLORIDE APOTEX INC AB 75MG AB 100MG MYLAN AB 75MG AB 100MG SANDOZ AB 75MG AB 100MG TEVA AB 75MG AB 100MG WELLBUTRIN GLAXOSMITHKLINE AB 75MG AB + 100MG TABLET, EXTENDED RELEASE; BUPROPION HYDROCHLORIDE ACTAVIS AB1 AB1 AB1 ANCHEN PHARMS AB1 AB1 AB1 IMPAX LABS AB1 AB1 AB1 MYLAN AB1 AB1 AB1 SANDOZ AB1 AB1 AB1 SUN PHARMA GLOBAL AB1 AB1 AB1 WATSON LABS FLORIDA AB1 AB1 AB1 WELLBUTRIN SR GLAXOSMITHKLINE AB1 AB1 + AB1 BUPROPION HYDROCHLORIDE ACTAVIS AB2 ANCHEN PHARMS AB2 IMPAX LABS AB2 MYLAN AB2 WATSON LABS FLORIDA AB2 ZYBAN AB2 + GLAXOSMITHKLINE BUPROPION HYDROCHLORIDE ACTAVIS AB3 AB3 ANCHEN PHARMS AB3 AB3 IMPAX LABS AB3 ORAL 100MG 150MG 200MG 100MG 150MG 200MG 100MG 150MG 200MG 100MG 150MG 200MG 100MG 150MG 200MG 100MG 150MG 200MG 100MG 150MG 200MG 100MG 150MG 200MG 150MG 150MG 150MG 150MG 150MG 150MG 150MG 300MG 150MG 300MG 150MG A077455 A077455 A077455 A091459 A091459 A091459 A075913 A075913 A076711 A090325 A090325 A090325 A075932 A075932 A075932 A078866 A078866 A078866 A079095 A079095 A079095 001 002 003 001 002 003 001 002 001 001 002 003 001 002 003 001 002 003 001 002 003 Jul Mar Jul Jun Jun Jun Jan Mar Dec Apr Apr Apr Nov Mar Jun Apr Apr Apr Mar Mar Mar 19, 12, 19, 09, 09, 09, 28, 22, 03, 08, 08, 08, 25, 22, 22, 06, 06, 06, 24, 24, 24, 2010 2008 2010 2011 2011 2011 2004 2004 2004 2010 2010 2010 2003 2004 2005 2010 2010 2010 2009 2009 2009

A076143 A076143 A075491 A075491 A075584 A075584 A075310 A075310

001 002 001 002 001 002 001 002

Jan Jan Apr Apr Feb Feb Nov Nov

17, 17, 17, 17, 07, 07, 29, 29,

2006 2006 2000 2000 2000 2000 1999 1999

N018644 002 N018644 003

Dec 30, 1985 Dec 30, 1985

N020358 002 N020358 003 N020358 004 A077475 A091520 A075914 A090941 A079094 001 001 001 001 001

Oct 04, 1996 Oct 04, 1996 Jun 14, 2002 Mar Jun May May Mar 12, 09, 27, 03, 24, 2008 2011 2004 2010 2009

N020711 003 A077285 A077285 A077284 A077284 A077415 001 002 001 002 001

May 14, 1997 Nov Aug Dec Dec Nov 26, 15, 14, 14, 26, 2008 2008 2006 2006 2008

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

BUPROPION HYDROCHLORIDE
TABLET, EXTENDED RELEASE; BUPROPION HYDROCHLORIDE IMPAX LABS AB3 MYLAN AB3 AB3 WATSON LABS AB3 AB3 WELLBUTRIN XL AB3 + VALEANT INTL AB3 FORFIVO XL XX + INTELGENX CORP ORAL 300MG 150MG 300MG 150MG 300MG 150MG 300MG 450MG A077415 A090942 A090942 A077715 A077715 002 001 002 001 002

3 - 63 (of 424)

Dec Jul Jul Nov Jun

15, 14, 14, 26, 13,

2006 2010 2010 2008 2007

N021515 001 N021515 002 N022497 001

Aug 28, 2003 Aug 28, 2003 Nov 10, 2011

BUSPIRONE HYDROCHLORIDE
TABLET; ORAL BUSPIRONE HYDROCHLORIDE APOTEX AB 5MG AB 10MG AB 15MG DR REDDYS LABS LTD AB 5MG AB 10MG AB 15MG AB 30MG EGIS AB 5MG AB 10MG AB 15MG MYLAN AB 5MG AB 5MG AB 7.5MG AB 10MG AB 10MG AB 15MG AB 15MG AB 30MG NESHER PHARMS AB 5MG AB 10MG AB 15MG TEVA AB 5MG AB 10MG AB + 15MG AB 30MG WATSON LABS AB 5MG AB 10MG AB 15MG

A075521 A075521 A075521 A078246 A078246 A078246 A078246 A075119 A075119 A075119 A075272 A075467 A075467 A075272 A075467 A075272 A075467 A076008 A075572 A075572 A075572 A075022 A075022 A075022 A075022 A074253 A074253 A074253

001 002 003 001 002 003 004 001 002 003 001 001 002 002 003 003 004 001 001 002 003 001 002 003 004 001 002 003

Apr Apr Apr Feb Feb Feb Feb Mar Mar Jan Mar Feb Mar Mar Feb Mar Feb Jun Feb Feb Feb Feb Feb Feb Mar Mar Mar Mar

05, 05, 05, 27, 27, 27, 27, 14, 14, 23, 01, 28, 28, 01, 28, 28, 28, 28, 27, 27, 27, 28, 28, 28, 25, 28, 28, 13,

2002 2002 2002 2009 2009 2009 2009 2002 2002 2003 2002 2002 2001 2002 2002 2001 2002 2001 2002 2002 2002 2002 2002 2002 2004 2001 2001 2002

BUSULFAN

INJECTABLE; INJECTION

BUSULFEX
XX + OTSUKA PHARM
TABLET; ORAL

MYLERAN
XX + ASPEN GLOBAL

6MG/ML

N020954 001

Feb 04, 1999

2MG

N009386 001

BUTABARBITAL SODIUM
ELIXIR; ORAL

BUTISOL SODIUM

XX + MEDA PHARMS

30MG/5ML

A085380 001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

BUTABARBITAL SODIUM
TABLET; ORAL

BUTISOL SODIUM

XX + MEDA PHARMS XX +

3 - 64 (of 424)

30MG 50MG

N000793 004 N000793 003

BUTENAFINE HYDROCHLORIDE

CREAM; TOPICAL

MENTAX
XX + MYLAN MENTAX-TC XX + MYLAN

1% 1%

N020524 001 N021408 001

Oct 18, 1996 Oct 17, 2002

BUTOCONAZOLE NITRATE

CREAM; VAGINAL

GYNAZOLE-1
XX + KV PHARM

2%

N019881 001

Feb 07, 1997

BUTORPHANOL TARTRATE
INJECTABLE; INJECTION BUTORPHANOL TARTRATE BEDFORD AP 2MG/ML CLARIS LIFESCIENCES AP 2MG/ML HIKMA FARMACEUTICA AP 1MG/ML AP 2MG/ML AP 2MG/ML BUTORPHANOL TARTRATE PRESERVATIVE FREE BEDFORD AP 1MG/ML AP 2MG/ML CLARIS LIFESCIENCES AP 1MG/ML AP 2MG/ML HOSPIRA AP 1MG/ML AP 2MG/ML STADOL AP + APOTHECON 2MG/ML STADOL PRESERVATIVE FREE AP + APOTHECON 1MG/ML AP + 2MG/ML SPRAY, METERED; NASAL BUTORPHANOL TARTRATE AB + MYLAN NOVEX AB ROXANE AB

A075046 A075697 A078400 A078247 A078400 A075045 A075045 A075695 A075695 A074626 A074626

001 001 001 001 002 001 002 001 002 001 002

Aug Oct May Apr May Aug Aug Oct Oct Jan Jan

12, 23, 01, 29, 01, 12, 12, 23, 23, 23, 23,

1998 2001 2009 2009 2009 1998 1998 2001 2001 1997 1997

N017857 004 N017857 001 N017857 002

1MG/SPRAY 1MG/SPRAY 1MG/SPRAY

A075759 001 A075499 001 A075824 001

Aug 08, 2001 Dec 04, 2002 Mar 12, 2002

CABAZITAXEL
SOLUTION; IV (INFUSION)
JEVTANA KIT
XX + SANOFI AVENTIS US

60MG/1.5ML (40MG/ML)

N201023 001

Jun 17, 2010

CABERGOLINE
TABLET; ORAL CABERGOLINE IMPAX LABS INC IVAX SUB TEVA PHARMS + PAR PHARM WATSON LABS

AB AB AB AB

0.5MG 0.5MG 0.5MG 0.5MG

A077843 A077750 A076310 A078035

001 001 001 001

Jul Mar Dec Apr

03, 07, 29, 21,

2007 2007 2005 2008

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

CAFFEINE CITRATE
SOLUTION; INTRAVENOUS CAFCIT + MEAD JOHNSON CAFFEINE CITRATE APP PHARMS LUITPOLD PADDOCK LLC SUN PHARMA GLOBAL SOLUTION; ORAL CAFCIT + MEAD JOHNSON CAFFEINE CITRATE APP PHARMS LUITPOLD PADDOCK LLC SUN PHARMA GLOBAL

3 - 65 (of 424)

AP AP AP AP AP

EQ 30MG BASE/3ML (EQ 10MG BASE/ML) EQ EQ EQ EQ 30MG 30MG 30MG 30MG BASE/3ML BASE/3ML BASE/3ML BASE/3ML (EQ (EQ (EQ (EQ 10MG 10MG 10MG 10MG BASE/ML) BASE/ML) BASE/ML) BASE/ML)

N020793 001 A077997 A077906 A077233 A090077 001 001 001 001

Sep 21, 1999 Jul May Sep Sep 20, 15, 21, 30, 2007 2007 2006 2009

AA AA AA AA AA

EQ 30MG BASE/3ML (EQ 10MG BASE/ML) EQ EQ EQ EQ 30MG 30MG 30MG 30MG BASE/3ML BASE/3ML BASE/3ML BASE/3ML (EQ (EQ (EQ (EQ 10MG 10MG 10MG 10MG BASE/ML) BASE/ML) BASE/ML) BASE/ML)

N020793 002 A078002 A090064 A077304 A090357 001 001 001 001

Apr 12, 2000 Jan Nov Sep Sep 31, 20, 21, 30, 2008 2009 2006 2009

CAFFEINE; ERGOTAMINE TARTRATE

SUPPOSITORY; RECTAL

MIGERGOT

XX + G AND W LABS

100MG;2MG

A086557 001

Oct 04, 1983

TABLET; ORAL CAFERGOT AA + SANDOZ 100MG;1MG ERGOTAMINE TARTRATE AND CAFFEINE MIKART AA 100MG;1MG WEST WARD AA 100MG;1MG

A084294 001 A040590 001 A040510 001 Sep 16, 2005 Sep 17, 2004

CALCIPOTRIENE

AEROSOL, FOAM; TOPICAL

SORILUX
XX + STIEFEL LABS INC
CREAM; TOPICAL

DOVONEX
XX + LEO PHARM
OINTMENT; TOPICAL

CALCIPOTRIENE
XX + GLENMARK GENERICS SOLUTION; TOPICAL CALCIPOTRIENE G AND W LABS INC HI TECH PHARMA NYCOMED US TOLMAR DOVONEX + LEO PHARM

0.005%

N022563 001

Oct 06, 2010

0.005%

N020554 001

Jul 22, 1996

0.005%

A090633 001

Mar 24, 2010

AT AT AT AT AT

0.005% 0.005% 0.005% 0.005% 0.005%

A078468 A077579 A078305 A077029

001 001 001 001

Mar Nov May Nov

24, 19, 06, 20,

2011 2009 2008 2009

N020611 001

Mar 03, 1997

CALCITONIN SALMON

INJECTABLE; INJECTION

MIACALCIN
XX + NOVARTIS SPRAY, METERED; NASAL CALCITONIN-SALMON APOTEX INC AB PAR PHARM AB MIACALCIN AB + NOVARTIS

200 IU/ML

N017808 002

Mar 29, 1991

200 IU/SPRAY 200 IU/SPRAY 200 IU/SPRAY

A076396 001 A076979 001 N020313 002

Nov 17, 2008 Jun 08, 2009 Aug 17, 1995

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

CALCITONIN SALMON RECOMBINANT
SPRAY, METERED; NASAL
FORTICAL
XX + UPSHER SMITH

3 - 66 (of 424)

200 IU/SPRAY

N021406 001

Aug 12, 2005

CALCITRIOL
CAPSULE; ORAL CALCITRIOL ROXANE AB TEVA AB AB ROCALTROL VALIDUS PHARMS AB AB + INJECTABLE; INJECTION CALCIJEX AP + ABBOTT AP + CALCITRIOL AKORN AP AP APP PHARMS AP AP FRESENIUS MEDCL AP AP LUITPOLD AP AP ROCKWELL MEDCL AP SAGENT PHARMS AP TEVA PARENTERAL AP OINTMENT; TOPICAL
VECTICAL
XX + GALDERMA LABS LP SOLUTION; ORAL CALCITRIOL ROXANE AA ROCALTROL AA + VALIDUS PHARMS

0.25MCG 0.25MCG 0.5MCG 0.25MCG 0.5MCG

A076917 001 A075765 001 A075765 002 N018044 001 N018044 002

Mar 27, 2006 Oct 12, 2001 Oct 12, 2001

0.001MG/ML 0.002MG/ML 0.001MG/ML 0.002MG/ML 0.001MG/ML 0.002MG/ML 0.001MG/ML 0.002MG/ML 0.001MG/ML 0.002MG/ML 0.001MG/ML 0.001MG/ML 0.002MG/ML

N018874 001 N018874 002 A078066 A078066 A075836 A075836 A075766 A075766 A075746 A075746 A076206 A077102 A075823 001 002 001 002 001 002 001 002 001 001 002

Sep 25, 1986 Sep 25, 1986 Jan Jan Dec Dec Feb Feb Sep Sep Sep Feb Mar 29, 29, 31, 31, 20, 20, 26, 26, 17, 08, 31, 2008 2008 2002 2002 2003 2003 2003 2003 2003 2006 2003

3MCG/GM

N022087 001

Jan 23, 2009

1MCG/ML 1MCG/ML

A076242 001 N021068 001

Jul 18, 2003 Nov 20, 1998

CALCIUM ACETATE
CAPSULE; ORAL CALCIUM ACETATE ROXANE AB PHOSLO GELCAPS AB + FRESENIUS MEDCL SOLUTION; ORAL
PHOSLYRA
XX + FRESENIUS MEDCL TABLET; ORAL CALCIUM ACETATE PADDOCK LLC AB ELIPHOS AB + CYPRESS PHARM

EQ 169MG CALCIUM EQ 169MG CALCIUM

A077728 001 N021160 003

Feb 26, 2008 Apr 02, 2001

EQ 169MG CALCIUM/5ML

N022581 001

Apr 18, 2011

EQ 169MG CALCIUM EQ 169MG CALCIUM

A091561 001 A078502 001

Apr 13, 2011 Nov 25, 2008

CALCIUM CHLORIDE
INJECTABLE; INJECTION
CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER
100MG/ML XX + HOSPIRA

N021117 001

Jan 28, 2000

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 67 (of 424)

CALCIUM CHLORIDE; DEXTROSE; GLUTATHIONE DISULFIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE
SOLUTION; IRRIGATION BSS PLUS AT + ALCON

0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/M L;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/M L 0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/M L;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/M L

N018469 001

AT

ENDOSOL EXTRA + AKORN

N020079 001

Nov 27, 1991

CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE

INJECTABLE; INJECTION

PRISMASOL B22GK 2/0 IN PLASTIC CONTAINER
N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.0 XX + GAMBRO RENAL PRODS 5GM/1000ML;0.157GM/1000ML;2.21GM/1000ML ;7.07GM/1000ML PRISMASOL B22GK 4/0 IN PLASTIC CONTAINER N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.0 XX + GAMBRO RENAL PRODS 5GM/1000ML;0.314GM/1000ML;2.21GM/1000ML ;7.07GM/1000ML PRISMASOL B22GK 4/2.5 IN PLASTIC CONTAINER 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML; XX + GAMBRO RENAL PRODS 3.05GM/1000ML;0.314GM/1000ML;2.21GM/100 0ML;7.07GM/1000ML PRISMASOL BGK 0/2.5 IN PLASTIC CONTAINER 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML; XX + GAMBRO RENAL PRODS 3.05GM/1000ML;N/A/1000ML;3.09GM/1000ML; 6.46GM/1000ML PRISMASOL BGK 2/0 IN PLASTIC CONTAINER N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.0 XX + GAMBRO RENAL PRODS 3GM/1000ML;0.157GM/1000ML;3.09GM/1000ML ;6.46GM/1000ML PRISMASOL BGK 2/3.5 IN PLASTIC CONTAINER 5.15GM/1000ML;20GM/1000ML;5.4GM/1000ML; XX + GAMBRO RENAL PRODS 2.03GM/1000ML;0.157GM/1000ML;3.09GM/100 0ML;6.46GM/1000ML PRISMASOL BGK 4/0/1.2 IN PLASTIC CONTAINER N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.4 XX + GAMBRO RENAL PRODS 4GM/1000ML;0.314GM/1000ML;3.09GM/1000ML ;6.46GM/1000ML PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML; XX + GAMBRO RENAL PRODS 3.05GM/1000ML;0.314GM/1000ML;3.09GM/100 0ML;6.46GM/1000ML PRISMASOL BK 0/0/1.2 IN PLASTIC CONTAINER N/A/1000ML;N/A/1000ML;5.4GM/1000ML;2.44 XX + GAMBRO RENAL PRODS GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46 GM/1000ML PRISMASOL BK 0/3.5 IN PLASTIC CONTAINER 5.15GM/1000ML;N/A/1000ML;5.4GM/1000ML;2 XX + GAMBRO RENAL PRODS .03GM/1000ML;N/A/1000ML;3.09GM/1000ML;6 .46GM/1000ML

N021703 010

Oct 10, 2008

N021703 011

Oct 10, 2008

N021703 013

Oct 10, 2008

N021703 006

Oct 25, 2006

N021703 002

Oct 25, 2006

N021703 003

Oct 25, 2006

N021703 015

Oct 10, 2008

N021703 004

Oct 25, 2006

N021703 014

Oct 10, 2008

N021703 001

Oct 25, 2006

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; OXIGLUTATIONE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE
SOLUTION; IRRIGATION

NAVSTEL

XX + ALCON PHARMS LTD

0.154MG/ML;0.92MG/ML;0.2MG/ML;0.184MG/M L;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/M L

N022193 001

Jul 24, 2008

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 68 (of 424)

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE
INJECTABLE; INJECTION

ISOLYTE R IN DEXTROSE 5% IN PLASTIC CONTAINER

37MG/100ML;5GM/100ML;31MG/100ML;120MG/1 XX + B BRAUN 00ML;330MG/100ML;88MG/100ML

N019864 001

Jun 10, 1993

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE

INJECTABLE; INJECTION

ISOLYTE E IN DEXTROSE 5% IN PLASTIC CONTAINER
XX + B BRAUN 35MG/100ML;5GM/100ML;30MG/100ML;74MG/10 0ML;640MG/100ML;500MG/100ML;74MG/100ML

N019867 001

Dec 20, 1993

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM LACTATE
INJECTABLE; INJECTION

PLASMA-LYTE M AND DEXTROSE 5% IN PLASTIC CONTAINER

37MG/100ML;5GM/100ML;30MG/100ML;119MG/1 XX + BAXTER HLTHCARE 00ML;161MG/100ML;94MG/100ML;138MG/100ML

N017390 001

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE

SOLUTION; INTRAPERITONEAL

DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER

+ B BRAUN 510MG/100ML;30GM/100ML;200MG/100ML;9.4G M/100ML;11GM/100ML + 510MG/100ML;30GM/100ML;200MG/100ML;9.2G M/100ML;9.6GM/100ML

DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER

+ B BRAUN 510MG/100ML;50GM/100ML;200MG/100ML;9.2G M/100ML;9.6GM/100ML + 510MG/100ML;50GM/100ML;200MG/100ML;9.4G M/100ML;11GM/100ML

XX XX

N018807 003 N018807 001

Aug 26, 1983 Aug 26, 1983

XX XX

N018807 002 N018807 004

Aug 26, 1983 Aug 26, 1983

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE

SOLUTION; INTRAPERITONEAL DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER FRESENIUS MEDCL 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;5 N018379 67MG/100ML;392MG/100ML 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;5 N018883 67MG/100ML;392MG/100ML DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER FRESENIUS MEDCL 25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;5 N018883 38MG/100ML;448MG/100ML DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER FRESENIUS MEDCL 18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;5 N020171 38MG/100ML;448MG/100ML DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER FRESENIUS MEDCL 25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;5 N018379 67MG/100ML;392MG/100ML 25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;5 N018883 67MG/100ML;392MG/100ML DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM IN PLASTIC CONTAINER FRESENIUS MEDCL 25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;5 N018883 38MG/100ML;448MG/100ML DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER FRESENIUS MEDCL 18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;5 N020171 38MG/100ML;448MG/100ML DELFLEX W/ DEXTROSE 3.5% IN PLASTIC CONTAINER FRESENIUS MEDCL 25.7MG/100ML;3.5GM/100ML;15.2MG/100ML;5 N018379 67MG/100ML;392MG/100ML

AT AT

002 001 Nov 30, 1984

AT

004

Nov 30, 1984

AT

001

Aug 19, 1992

AT AT

003 002 Nov 30, 1984

AT

005

Nov 30, 1984

AT

002

Aug 19, 1992

AT

007

Jun 24, 1988

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 69 (of 424)

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE

SOLUTION; INTRAPERITONEAL DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER FRESENIUS MEDCL 25.7MG/100ML;4.25GM/100ML;15.2MG/100ML; N018379 567MG/100ML;392MG/100ML 25.7MG/100ML;4.25GM/100ML;15.2MG/100ML; N018883 567MG/100ML;392MG/100ML DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER FRESENIUS MEDCL 25.7MG/100ML;4.25GM/100ML;5.08MG/100ML; N018883 538MG/100ML;448MG/100ML DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER FRESENIUS MEDCL 18.4MG/100ML;4.25GM/100ML;5.08MG/100ML; N020171 538MG/100ML;448MG/100ML DELFLEX-LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER FRESENIUS MEDCL 25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;5 N018379 38MG/100ML;448MG/100ML DELFLEX-LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER FRESENIUS MEDCL 25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;5 N018379 38MG/100ML;448MG/100ML DELFLEX-LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER FRESENIUS MEDCL 25.7MG/100ML;3.5GM/100ML;5.08MG/100ML;5 N018379 38MG/100ML;448MG/100ML DELFLEX-LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER FRESENIUS MEDCL 25.7MG/100ML;4.25GM/100ML;5.08MG/100ML; N018379 538MG/100ML;448MG/100ML DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER BAXTER HLTHCARE 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;5 N017512 67MG/100ML;392MG/100ML DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER BAXTER HLTHCARE 25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;5 N017512 67MG/100ML;392MG/100ML DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER BAXTER HLTHCARE 25.7MG/100ML;4.25GM/100ML;15.2MG/100ML; N017512 567MG/100ML;392MG/100ML DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER BAXTER HLTHCARE 18.3MG/100ML;1.5GM/100ML;5.08MG/100ML;5 N020183 38MG/100ML;448MG/100ML DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER BAXTER HLTHCARE 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;5 N017512 67MG/100ML;392MG/100ML DIANEAL PD-1 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER BAXTER HLTHCARE 25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;5 N017512 67MG/100ML;392MG/100ML DIANEAL PD-1 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER BAXTER HLTHCARE 25.7MG/100ML;3.5GM/100ML;15.2MG/100ML;5 N017512 67MG/100ML;392MG/100ML DIANEAL PD-1 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER BAXTER HLTHCARE 25.7MG/100ML;4.25GM/100ML;15.2MG/100ML; N017512 567MG/100ML;392MG/100ML DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER BAXTER HLTHCARE 18.3MG/100ML;1.5GM/100ML;5.08MG/100ML;5 N017512 38MG/100ML;448MG/100ML 25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;5 N020163 38MG/100ML;448MG/100ML DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER BAXTER HLTHCARE 25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;5 N017512 38MG/100ML;448MG/100ML 25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;5 N020163 38MG/100ML;448MG/100ML DIANEAL PD-2 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER BAXTER HLTHCARE 25.7MG/100ML;3.5GM/100ML;5.08MG/100ML;5 N017512 38MG/100ML;448MG/100ML DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER BAXTER HLTHCARE 25.7MG/100ML;4.25GM/100ML;5.08MG/100ML; N017512 538MG/100ML;448MG/100ML

AT AT

001 003 Nov 30, 1984

AT

006

Nov 30, 1984

AT

003

Aug 19, 1992

AT

004

Jul 07, 1982

AT

005

Jul 07, 1982

AT

008

Jun 24, 1988

AT

006

Jul 07, 1982

AT

001

AT

003

AT

002

AT

001

Dec 04, 1992

AT

007

Jul 09, 1984

AT

008

Jul 09, 1984

AT

010

Nov 18, 1985

AT

009

Jul 09, 1984

AT AT

004 001 Dec 04, 1992

AT AT

005 002 Dec 04, 1992

AT

011

Nov 18, 1985

AT

006

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 70 (of 424)

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE

SOLUTION; INTRAPERITONEAL DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER BAXTER HLTHCARE 25.7MG/100ML;4.25GM/100ML;5.08MG/100ML; 538MG/100ML;448MG/100ML INPERSOL-LC/LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER FRESENIUS 18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;5 38MG/100ML;448MG/100ML INPERSOL-LC/LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER FRESENIUS 18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;5 38MG/100ML;448MG/100ML INPERSOL-LC/LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER FRESENIUS 18.4MG/100ML;4.25GM/100ML;5.08MG/100ML; 538MG/100ML;448MG/100ML DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER B BRAUN 26MG/100ML;1.5GM/100ML;5MG/100ML;530MG/ 100ML;450MG/100ML DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER B BRAUN 26MG/100ML;2.5GM/100ML;5MG/100ML;530MG/ 100ML;450MG/100ML DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER B BRAUN 26MG/100ML;4.25GM/100ML;5MG/100ML;530MG /100ML;450MG/100ML DIANEAL LOW CALCIUM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER BAXTER HLTHCARE 18.3MG/100ML;2.5GM/100ML;5.08MG/100ML;5 38MG/100ML;448MG/100ML DIANEAL LOW CALCIUM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER BAXTER HLTHCARE 18.3MG/100ML;3.5GM/100ML;5.08MG/100ML;5 38MG/100ML;448MG/100ML DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER BAXTER HLTHCARE 18.3MG/100ML;4.25GM/100ML;5.08MG/100ML; 538MG/100ML;448MG/100ML INPERSOL-LC/LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER FRESENIUS 18.4MG/100ML;3.5GM/100ML;5.08MG/100ML;5 38MG/100ML;448MG/100ML

AT

N020163 003

Dec 04, 1992

AT

N020374 001

Jun 13, 1994

AT

N020374 002

Jun 13, 1994

AT

N020374 004

Jun 13, 1994

XX

N018460 007

Jan 29, 1986

XX

N018460 005

Nov 02, 1983

XX

N018460 009

Jan 29, 1986

XX

N020183 002

Dec 04, 1992

XX

N020183 003

Dec 04, 1992

XX

N020183 004

Dec 04, 1992

XX

N020374 003

Jun 13, 1994

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
INJECTABLE; INTRATHECAL

ELLIOTTS B SOLUTION

XX + QOL MEDCL

0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9 MG/ML;7.3MG/ML;0.2MG/ML

N020577 001

Sep 27, 1996

CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE

INJECTABLE; INJECTION

DEXTROSE 5% IN ACETATED RINGER'S IN PLASTIC CONTAINER
20MG/100ML;5GM/100ML;30MG/100ML;380MG/1 XX + B BRAUN
00ML;600MG/100ML

N018258 001

CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

INJECTABLE; INJECTION DEXTROSE 5% AND RINGER'S IN PLASTIC CONTAINER HOSPIRA AP 33MG/100ML;5GM/100ML;30MG/100ML;860MG/1 00ML DEXTROSE 5% IN RINGER'S IN PLASTIC CONTAINER B BRAUN AP 33MG/100ML;5GM/100ML;30MG/100ML;860MG/1 00ML BAXTER HLTHCARE AP 33MG/100ML;5GM/100ML;30MG/100ML;860MG/1 00ML

N018254 001

N020000 001 N016695 001

Apr 17, 1992

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 71 (of 424)

CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE

INJECTABLE; INJECTION DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER HOSPIRA 20MG/100ML;5GM/100ML;30MG/100ML;600MG/1 N017608 001 00ML;310MG/100ML DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER B BRAUN Feb 20MG/100ML;5GM/100ML;30MG/100ML;600MG/1 N019634 003 00ML;310MG/100ML LACTATED RINGER'S AND DEXTROSE 5% IN PLASTIC CONTAINER BAXTER HLTHCARE 20MG/100ML;5GM/100ML;30MG/100ML;600MG/1 N016679 001 00ML;310MG/100ML POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER BAXTER HLTHCARE Apr 20MG/100ML;5GM/100ML;254MG/100ML;600MG/ N019367 006 100ML;310MG/100ML POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER BAXTER HLTHCARE Apr 20MG/100ML;5GM/100ML;179MG/100ML;600MG/ N019367 004 100ML;310MG/100ML Apr 20MG/100ML;5GM/100ML;328MG/100ML;600MG/ N019367 005 100ML;310MG/100ML HOSPIRA Oct 20MG/100ML;5GM/100ML;179MG/100ML;600MG/ N019685 002 100ML;310MG/100ML Oct 20MG/100ML;5GM/100ML;328MG/100ML;600MG/ N019685 008 100ML;310MG/100ML POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER BAXTER HLTHCARE Apr 20MG/100ML;5GM/100ML;254MG/100ML;600MG/ N019367 007 100ML;310MG/100ML POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER BAXTER HLTHCARE Apr 20MG/100ML;5GM/100ML;328MG/100ML;600MG/ N019367 008 100ML;310MG/100ML HOSPIRA Oct 20MG/100ML;5GM/100ML;328MG/100ML;600MG/ N019685 004 100ML;310MG/100ML DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINER B BRAUN 10MG/100ML;2.5GM/100ML;15MG/100ML;300MG N019634 001 Feb /100ML;160MG/100ML POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER BAXTER HLTHCARE 20MG/100ML;5GM/100ML;105MG/100ML;600MG/ N019367 002 Apr 100ML;310MG/100ML 20MG/100ML;5GM/100ML;179MG/100ML;600MG/ N019367 003 Apr 100ML;310MG/100ML POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER BAXTER HLTHCARE 20MG/100ML;5GM/100ML;105MG/100ML;600MG/ N019367 001 Apr 100ML;310MG/100ML

AP

AP

24, 1988

AP

AP

05, 1985

AP AP AP AP

05, 1985 05, 1985 17, 1988 17, 1988

AP

05, 1985

AP AP

05, 1985 17, 1988

XX

24, 1988

XX XX

05, 1985 05, 1985

XX

05, 1985

CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE

INJECTABLE; INJECTION

TPN ELECTROLYTES IN PLASTIC CONTAINER
16.5MG/ML;25.4MG/ML;74.6MG/ML;121MG/ML; XX + HOSPIRA 16.1MG/ML

N018895 001

Jul 20, 1984

CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE
INJECTABLE; INJECTION

ISOLYTE E IN PLASTIC CONTAINER

35MG/100ML;30MG/100ML;74MG/100ML;640MG/ XX + B BRAUN 100ML;500MG/100ML;74MG/100ML SOLUTION; IRRIGATION BALANCED SALT AKORN AT AT B BRAUN

N019718 001

Sep 29, 1989

0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6 .4MG/ML;1.7MG/ML 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6 .4MG/ML;1.7MG/ML

A075503 001 A091387 001

Sep 27, 2006 Feb 03, 2010

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 72 (of 424)

CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE
SOLUTION; IRRIGATION BSS AT + ALCON

0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6 .4MG/ML;1.7MG/ML

N020742 001

Dec 10, 1997

CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM LACTATE

INJECTABLE; INJECTION

PLASMA-LYTE R IN PLASTIC CONTAINER
XX + BAXTER HLTHCARE 36.8MG/100ML;30.5MG/100ML;74.6MG/100ML;
640MG/100ML;496MG/100ML;89.6MG/100ML

N017438 001

CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

SOLUTION; PERFUSION, CARDIAC CARDIOPLEGIC IN PLASTIC CONTAINER BAXTER HLTHCARE AT 17.6MG/100ML;325.3MG/100ML;119.3MG/100M L;643MG/100ML PLEGISOL IN PLASTIC CONTAINER AT + HOSPIRA 17.6MG/100ML;325.3MG/100ML;119.3MG/100M L;643MG/100ML

A075323 001

Apr 21, 2000

N018608 001

Feb 26, 1982

CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

INJECTABLE; INJECTION RINGER'S IN PLASTIC CONTAINER B BRAUN AP 33MG/100ML;30MG/100ML;860MG/100ML BAXTER HLTHCARE AP 33MG/100ML;30MG/100ML;860MG/100ML HOSPIRA AP 33MG/100ML;30MG/100ML;860MG/100ML SOLUTION; IRRIGATION RINGER'S IN PLASTIC CONTAINER B BRAUN AT 33MG/100ML;30MG/100ML;860MG/100ML BAXTER HLTHCARE AT 33MG/100ML;30MG/100ML;860MG/100ML HOSPIRA AT 33MG/100ML;30MG/100ML;860MG/100ML

N020002 001 N016693 001 N018251 001

Apr 17, 1992

N018156 001 N018495 001 N017635 001

Feb 19, 1982

CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE

INJECTABLE; INJECTION LACTATED RINGER'S IN PLASTIC CONTAINER B BRAUN AP 20MG/100ML;30MG/100ML;600MG/100ML;310MG /100ML BAXTER HLTHCARE AP 20MG/100ML;30MG/100ML;600MG/100ML;310MG /100ML HOSPIRA AP 20MG/100ML;30MG/100ML;600MG/100ML;310MG /100ML SOLUTION; IRRIGATION LACTATED RINGER'S IN PLASTIC CONTAINER B BRAUN AT 20MG/100ML;30MG/100ML;600MG/100ML;310MG /100ML BAXTER HLTHCARE AT 20MG/100ML;30MG/100ML;600MG/100ML;310MG /100ML AT 20MG/100ML;30MG/100ML;600MG/100ML;310MG /100ML AT 20MG/100ML;30MG/100ML;600MG/100ML;310MG /100ML HOSPIRA AT 20MG/100ML;30MG/100ML;600MG/100ML;310MG /100ML

N019632 001 N016682 001 N017641 001

Feb 29, 1988

N018681 001 N018494 001 N018921 001 N019933 001 N019416 001

Dec 27, 1982 Feb 19, 1982 Apr 03, 1984 Aug 29, 1989 Jan 17, 1986

CALFACTANT

SUSPENSION; INTRATRACHEAL

INFASURF PRESERVATIVE FREE
35MG/ML XX + ONY

N020521 001

Jul 01, 1998

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

CANDESARTAN CILEXETIL
TABLET; ORAL ATACAND ASTRAZENECA XX XX XX XX +

3 - 73 (of 424)

4MG 8MG 16MG 32MG

N020838 N020838 N020838 N020838

001 002 003 004

Jun Jun Jun Jun

04, 04, 04, 04,

1998 1998 1998 1998

CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

TABLET; ORAL ATACAND HCT ASTRAZENECA XX XX XX +

16MG;12.5MG 32MG;12.5MG 32MG;25MG

N021093 001 N021093 002 N021093 003

Sep 05, 2000 Sep 05, 2000 May 16, 2008

CAPECITABINE
TABLET; ORAL XELODA HOFFMANN LA ROCHE XX XX +

150MG 500MG

N020896 001 N020896 002

Apr 30, 1998 Apr 30, 1998

CAPREOMYCIN SULFATE
INJECTABLE; INJECTION
CAPASTAT SULFATE
XX + AKORN

EQ 1GM BASE/VIAL

N050095 001

CAPSAICIN
PATCH; TOPICAL
QUTENZA
XX + NEUROGESX

8%

N022395 001

Nov 16, 2009

CAPTOPRIL
TABLET; ORAL CAPOTEN PAR PHARM AB AB AB AB + CAPTOPRIL APOTEX AB AB AB AB MYLAN AB AB AB AB PRINSTON INC AB AB AB AB SANDOZ AB AB AB AB STASON AB AB AB AB

12.5MG 25MG 50MG 100MG 12.5MG 25MG 50MG 100MG 12.5MG 25MG 50MG 100MG 12.5MG 25MG 50MG 100MG 12.5MG 25MG 50MG 100MG 12.5MG 25MG 50MG 100MG

N018343 N018343 N018343 N018343 A074737 A074737 A074737 A074737 A074434 A074434 A074434 A074434 A074477 A074477 A074477 A074477 A074363 A074363 A074363 A074363 A074677 A074677 A074677 A074677

005 002 001 003 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 004 002 001 003

Jan 17, 1985

Oct Oct Oct Oct Feb Feb Feb Feb Feb Feb Feb Feb Nov Nov Nov Nov May May May May

28, 28, 28, 28, 13, 13, 13, 13, 13, 13, 13, 13, 09, 09, 09, 09, 30, 30, 30, 30,

1998 1998 1998 1998 1996 1996 1996 1996 1996 1996 1996 1996 1995 1995 1995 1995 1997 1997 1997 1997

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

CAPTOPRIL
TABLET; ORAL CAPTOPRIL TEVA AB AB AB AB AB AB AB AB WATSON LABS AB AB AB AB AB AB AB AB WEST WARD AB AB AB AB WOCKHARDT AB AB AB AB

3 - 74 (of 424)

12.5MG 12.5MG 25MG 25MG 50MG 50MG 100MG 100MG 12.5MG 12.5MG 25MG 25MG 50MG 50MG 100MG 100MG 12.5MG 25MG 50MG 100MG 12.5MG 25MG 50MG 100MG

A074322 A074483 A074322 A074483 A074322 A074483 A074322 A074483 A074386 A074451 A074386 A074451 A074386 A074451 A074386 A074451 A074505 A074505 A074505 A074505 A074532 A074532 A074532 A074532

001 001 002 002 003 003 004 004 001 001 002 002 003 003 004 004 001 002 003 004 001 002 003 004

Feb Feb Feb Feb Feb Feb Feb Feb May Feb May Feb May Feb May Feb Feb Feb Feb Feb Mar Mar Mar Mar

13, 13, 13, 13, 13, 13, 13, 13, 23, 13, 23, 13, 23, 13, 23, 13, 13, 13, 13, 13, 28, 28, 28, 28,

1996 1996 1996 1996 1996 1996 1996 1996 1996 1996 1996 1996 1996 1996 1996 1996 1996 1996 1996 1996 1997 1997 1997 1997

CAPTOPRIL; HYDROCHLOROTHIAZIDE
TABLET; ORAL CAPOZIDE 25/15 APOTHECON 25MG;15MG CAPOZIDE 25/25 + APOTHECON 25MG;25MG CAPOZIDE 50/15 + APOTHECON 50MG;15MG CAPOZIDE 50/25 APOTHECON 50MG;25MG CAPTOPRIL AND HYDROCHLOROTHIAZIDE MYLAN 25MG;15MG 25MG;25MG 50MG;15MG 50MG;25MG TEVA 25MG;15MG 25MG;25MG 50MG;15MG 50MG;25MG

AB AB AB AB AB AB AB AB AB AB AB AB

N018709 001 N018709 002 N018709 004 N018709 003 A074896 A074896 A074896 A074896 A074827 A074827 A074827 A074827 001 002 004 003 001 002 004 003

Oct 12, 1984 Oct 12, 1984 Oct 12, 1984 Oct 12, 1984 Dec Dec Dec Dec Dec Dec Dec Dec 29, 29, 29, 29, 29, 29, 29, 29, 1997 1997 1997 1997 1997 1997 1997 1997

CARBACHOL
SOLUTION; INTRAOCULAR

MIOSTAT

XX + ALCON

0.01%

N016968 001

CARBAMAZEPINE
CAPSULE, EXTENDED RELEASE; ORAL CARBAMAZEPINE APOTEX INC AB 100MG AB 200MG AB 300MG NOSTRUM AB 100MG

A078986 A078986 A078986 A076697

001 002 003 001

Nov Nov Nov May

25, 25, 25, 20,

2011 2011 2011 2011

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

CARBAMAZEPINE
CAPSULE, EXTENDED RELEASE; ORAL CARBAMAZEPINE NOSTRUM 200MG AB 300MG AB CARBATROL SHIRE 100MG AB 200MG AB 300MG AB + EQUETRO VALIDUS PHARMS INC 100MG XX 200MG XX 300MG XX + SUSPENSION; ORAL CARBAMAZEPINE WOCKHARDT AB TEGRETOL AB + NOVARTIS TERIL TARO AB TABLET; ORAL CARBAMAZEPINE APOTEX INC TARO TORRENT PHARMS EPITOL TEVA TEGRETOL + NOVARTIS CARBAMAZEPINE TORRENT PHARMS

3 - 75 (of 424)

A076697 002 A076697 003 N020712 003 N020712 001 N020712 002 N021710 001 N021710 002 N021710 003

May 20, 2011 May 20, 2011 Sep 30, 1997 Sep 30, 1997 Sep 30, 1997 Dec 10, 2004 Dec 10, 2004 Dec 10, 2004

100MG/5ML 100MG/5ML 100MG/5ML

A075714 001 N018927 001 A076729 001

Jun 05, 2002 Dec 18, 1987 Sep 20, 2004

AB AB AB AB AB XX XX XX

200MG 200MG 200MG 200MG 200MG 100MG 300MG 400MG

A075948 001 A074649 001 A077272 002 A070541 001 N016608 001 A077272 001 A077272 003 A077272 004

Feb 27, 2002 Oct 03, 1996 Dec 07, 2005 Sep 17, 1986

Dec 07, 2005 Dec 07, 2005 Dec 07, 2005

AB AB AB AB XX

TABLET, CHEWABLE; ORAL CARBAMAZEPINE TARO PHARM INDS TORRENT PHARMS EPITOL TEVA TEGRETOL + NOVARTIS CARBAMAZEPINE + TARO PHARM INDS

100MG 100MG 100MG 100MG 200MG

A075687 001 A075712 001 A073524 001 N018281 001 A075687 002

Oct 24, 2000 Jul 05, 2001 Jul 29, 1992

Jul 29, 2002

TABLET, EXTENDED RELEASE; ORAL CARBAMAZEPINE TARO 100MG AB 200MG AB 400MG AB TEGRETOL-XR NOVARTIS AB 100MG AB 200MG AB + 400MG

A078115 001 A078115 002 A078115 003 N020234 001 N020234 002 N020234 003

Mar 31, 2009 Mar 31, 2009 Mar 31, 2009 Mar 25, 1996 Mar 25, 1996 Mar 25, 1996

CARBIDOPA
TABLET; ORAL

LODOSYN

XX + ATON

25MG

N017830 001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

CARBIDOPA; ENTACAPONE; LEVODOPA
TABLET; ORAL

STALEVO 100

ORION STALEVO 125

ORION STALEVO 150

ORION STALEVO 200

+ ORION STALEVO 50

+ ORION STALEVO 75

ORION

3 - 76 (of 424)

XX XX XX XX XX XX

25MG;200MG;100MG 31.25MG;200MG;125MG 37.5MG;200MG;150MG 50MG;200MG;200MG 12.5MG;200MG;50MG 18.75MG;200MG;75MG

N021485 002 N021485 006 N021485 003 N021485 004 N021485 001 N021485 005

Jun 11, 2003

Aug 29, 2008

Jun 11, 2003

Aug 02, 2007

Jun 11, 2003

Aug 29, 2008

CARBIDOPA; LEVODOPA
TABLET; ORAL CARBIDOPA AND LEVODOPA ACTAVIS ELIZABETH AB AB AB APOTEX INC AB AB AB MYLAN AB AB AB SUN PHARM INDS AB AB AB TEVA AB AB AB SINEMET MERCK SHARP DOHME AB AB AB +

10MG;100MG 25MG;100MG 25MG;250MG 10MG;100MG 25MG;100MG 25MG;250MG 10MG;100MG 25MG;100MG 25MG;250MG 10MG;100MG 25MG;100MG 25MG;250MG 10MG;100MG 25MG;100MG 25MG;250MG 10MG;100MG 25MG;100MG 25MG;250MG

A074260 A074260 A074260 A077120 A077120 A077120 A090324 A090324 A090324 A078536 A078536 A078536 A073618 A073589 A073607

001 002 003 001 002 003 001 002 003 001 002 003 001 001 001

Sep Sep Sep Jun Jun Jun Sep Sep Sep Oct Oct Oct Aug Aug Aug

03, 03, 03, 02, 02, 02, 28, 28, 28, 28, 28, 28, 28, 28, 28,

1993 1993 1993 2008 2008 2008 2009 2009 2009 2008 2008 2008 1992 1992 1992

N017555 001 N017555 003 N017555 002

TABLET, EXTENDED RELEASE; ORAL CARBIDOPA AND LEVODOPA APOTEX AB 25MG;100MG AB 50MG;200MG IMPAX LABS AB 25MG;100MG AB 50MG;200MG MYLAN AB 25MG;100MG AB 50MG;200MG SUN PHARM INDS AB 25MG;100MG AB 50MG;200MG SINEMET CR MERCK SHARP DOHME AB 25MG;100MG AB + 50MG;200MG TABLET, ORALLY DISINTEGRATING; ORAL CARBIDOPA AND LEVODOPA IMPAX LABS 10MG;100MG 25MG;100MG 25MG;250MG MYLAN 10MG;100MG 25MG;100MG 25MG;250MG SUN PHARM INDS 10MG;100MG 25MG;100MG

A076212 A076212 A076521 A076521 A075091 A075091 A077828 A077828

001 002 001 002 002 001 001 002

Jun Jun May May Apr Sep Aug Aug

16, 16, 14, 14, 21, 30, 23, 23,

2004 2004 2004 2004 2000 1999 2007 2007

N019856 002 N019856 001

Dec 24, 1992 May 30, 1991

AB AB AB AB AB AB AB AB

A090631 A090631 A090631 A078893 A078893 A078893 A078690 A078690

001 002 003 001 002 003 001 002

Jun Jun Jun Sep Sep Sep Jul Jul

08, 08, 08, 18, 18, 18, 31, 31,

2010 2010 2010 2008 2008 2008 2009 2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

CARBIDOPA; LEVODOPA
TABLET, ORALLY DISINTEGRATING; ORAL CARBIDOPA AND LEVODOPA SUN PHARM INDS 25MG;250MG PARCOPA SCHWARZ PHARMA 10MG;100MG 25MG;100MG + 25MG;250MG

3 - 77 (of 424)

AB AB AB AB

A078690 003 A076699 001 A076699 002 A076699 003

Jul 31, 2009 Aug 27, 2004 Aug 27, 2004 Aug 27, 2004

CARBINOXAMINE MALEATE
SOLUTION; ORAL CARBINOXAMINE MALEATE BOCA PHARMA AA CYPRESS PHARM AA AA + MIKART TABLET; ORAL CARBINOXAMINE MALEATE BOCA PHARMA CYPRESS PHARM INVAGEN PHARMS LYNROSE LABS + MIKART

4MG/5ML 4MG/5ML 4MG/5ML

A040814 001 A090418 001 A040458 001

Feb 26, 2008 May 04, 2010 Apr 25, 2003

AA AA AA AA AA

4MG 4MG 4MG 4MG 4MG

A040639 A090417 A090435 A090756 A040442

002 001 001 001 001

May Aug Apr May Mar

30, 23, 15, 27, 19,

2008 2010 2010 2011 2003

CARBOPLATIN
INJECTABLE; INJECTION CARBOPLATIN APP PHARMS AP AP AP BEDFORD AP AP AP PLIVA AP AP AP SANDOZ AP AP AP AP + WATSON LABS AP AP + AP AP + AP

50MG/VIAL 150MG/VIAL 450MG/VIAL 50MG/VIAL 150MG/VIAL 450MG/VIAL 50MG/VIAL 150MG/VIAL 450MG/VIAL 50MG/VIAL 150MG/VIAL 450MG/VIAL 50MG/VIAL 50MG/VIAL 150MG/VIAL 150MG/VIAL 450MG/VIAL 450MG/VIAL

A076235 A076235 A076235 A076099 A076099 A076099 A076602 A076602 A076602 A076959 A076959 A076959 A076162 A077383 A076162 A077383 A076162 A077383

001 002 003 001 002 003 001 002 003 001 002 003 001 001 002 002 003 003

Oct Oct Oct Oct Oct Oct Nov Nov Nov Mar Mar Mar Oct Jan Oct Jan Oct Jan

14, 14, 14, 14, 14, 14, 16, 16, 16, 18, 18, 18, 14, 27, 14, 27, 14, 27,

2004 2004 2004 2004 2004 2004 2004 2004 2004 2005 2005 2005 2004 2006 2004 2006 2004 2006

INJECTABLE; IV (INFUSION) CARBOPLATIN AKORN AP 50MG/5ML (10MG/ML) AP 150MG/15ML (10MG/ML) AP 450MG/45ML (10MG/ML) AP 600MG/60ML (10MG/ML) APP PHARMS AP 50MG/5ML (10MG/ML) AP 150MG/15ML (10MG/ML) AP 450MG/45ML (10MG/ML) AP 450MG/45ML (10MG/ML) AP 600MG/60ML (10MG/ML) BEDFORD LABS AP 50MG/5ML (10MG/ML) AP 150MG/15ML (10MG/ML) AP 450MG/45ML (10MG/ML) AP 600MG/60ML (10MG/ML) BIONICHE PHARMA USA AP 50MG/5ML (10MG/ML)

A090475 A090475 A090475 A091268 A077266 A077266 A077247 A077266 A077266 A077244 A077244 A077244 A077244 A077998

001 002 003 002 001 002 003 003 004 001 002 003 004 001

Jul Jul Jul Jul Feb Feb Oct Feb Feb Oct Oct Oct Jan Apr

29, 29, 29, 28, 15, 15, 21, 15, 15, 15, 15, 15, 20, 24,

2009 2009 2009 2010 2006 2006 2004 2006 2006 2004 2004 2004 2006 2007

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

CARBOPLATIN
INJECTABLE; IV (INFUSION) CARBOPLATIN BIONICHE PHARMA USA AP 150MG/15ML (10MG/ML) AP 450MG/45ML (10MG/ML) EBEWE PHARMA AP 50MG/5ML (10MG/ML) AP 150MG/15ML (10MG/ML) AP 450MG/45ML (10MG/ML) FRESENIUS KABI ONCOL 450MG/45ML (10MG/ML) AP AP 50MG/5ML (10MG/ML) AP 150MG/15ML (10MG/ML) HOSPIRA AP 50MG/5ML (10MG/ML) AP 150MG/15ML (10MG/ML) AP 450MG/45ML (10MG/ML) AP 600MG/60ML (10MG/ML) ONCO THERAPIES LTD AP 50MG/5ML (10MG/ML) AP 150MG/15ML (10MG/ML) AP 450MG/45ML (10MG/ML) AP 600MG/60ML (10MG/ML) AP + PHARMACHEMIE 50MG/5ML (10MG/ML) AP + 150MG/15ML (10MG/ML) AP + 450MG/45ML (10MG/ML) AP + 600MG/60ML (10MG/ML) PHARMACHEMIE BV AP 50MG/5ML (10MG/ML) AP 150MG/15ML (10MG/ML) AP 450MG/45ML (10MG/ML) PLIVA LACHEMA AP 50MG/5ML (10MG/ML) AP 150MG/15ML (10MG/ML) AP 450MG/45ML (10MG/ML) AP 600MG/60ML (10MG/ML) SUN PHARMA GLOBAL AP 50MG/5ML (10MG/ML) AP 150MG/15ML (10MG/ML) AP 450MG/45ML (10MG/ML) AP + TEVA PARENTERAL 50MG/5ML (10MG/ML) AP + 150MG/15ML (10MG/ML) AP + 450MG/45ML (10MG/ML) AP + 600MG/60ML (10MG/ML) WATSON LABS AP 50MG/5ML (10MG/ML) AP 150MG/15ML (10MG/ML) AP 450MG/45ML (10MG/ML) AP 600MG/60ML (10MG/ML) CARBOPLATIN 1GM/100ML (10MG/ML) XX + ONCO THERAPIES LTD

3 - 78 (of 424)

A077998 A077998 A078280 A078280 A078280 A077432 A077432 A077432 A076517 A076517 A076517 A077059 A091063 A091063 A091063 A091063 A077269 A077269 A077269 A077269 A077679 A077679 A077679 A078631 A078631 A078631 A078631 A077926 A077926 A077926 A077139 A077139 A077139 A077139 A077861 A077861 A077861 A077861

002 003 001 002 003 003 001 002 001 002 003 001 001 002 003 004 001 002 003 004 001 002 003 001 002 003 004 001 002 003 001 002 003 004 001 002 003 004

Apr Apr May May May Sep Sep Sep Oct Oct Oct Nov Nov Nov Nov Nov Oct Oct Oct Dec Feb Feb Feb Dec Dec Dec Dec Sep Sep Sep Sep Sep Sep Sep Jan Jan Jan Jan

24, 24, 08, 08, 08, 29, 29, 29, 14, 14, 14, 23, 09, 09, 09, 09, 14, 14, 14, 28, 25, 25, 25, 02, 02, 02, 02, 19, 19, 19, 21, 21, 21, 21, 18, 18, 18, 18,

2007 2007 2008 2008 2008 2006 2006 2006 2004 2004 2004 2004 2011 2011 2011 2011 2004 2004 2004 2007 2009 2009 2009 2008 2008 2008 2008 2008 2008 2008 2005 2005 2005 2005 2007 2007 2007 2007

A091478 001

Nov 23, 2011

CARBOPROST TROMETHAMINE
INJECTABLE; INJECTION

HEMABATE

XX + PHARMACIA AND UPJOHN

EQ 0.25MG BASE/ML

N017989 001

CARGLUMIC ACID

TABLET; ORAL

CARBAGLU
XX + ORPHAN EUROPE

200MG

N022562 001

Mar 18, 2010

CARISOPRODOL
TABLET; ORAL CARISOPRODOL ADVENT PHARMS AA AUROBINDO PHARMA AA COREPHARMA AA

350MG 350MG 350MG

A040576 001 A040792 001 A040397 001

Jun 07, 2005 Aug 06, 2009 Sep 21, 2000

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

CARISOPRODOL
TABLET; ORAL CARISOPRODOL MIRROR PHARMS MUTUAL PHARM PROSAM LABS SUN PHARM INDS LTD VINTAGE PHARMS WATSON LABS WEST WARD SOMA MEDA PHARMS SOMA + MEDA PHARMS

3 - 79 (of 424)

AA AA AA AA AA AA AA AA XX

350MG 350MG 350MG 350MG 350MG 350MG 350MG 350MG 250MG

A040823 A089346 A040188 A040755 A040245 A087499 A040124

001 001 001 001 001 001 001

Oct Oct Mar Feb Sep Apr Jan

22, 17, 07, 27, 08, 20, 24,

2008 1991 1997 2007 1997 1982 1996

N011792 001 N011792 004 Sep 13, 2007

CARMUSTINE
IMPLANT; INTRACRANIAL

GLIADEL

XX + EISAI INC INJECTABLE; INJECTION

BICNU

XX + BRISTOL

7.7MG

N020637 001

Sep 23, 1996

100MG/VIAL

N017422 001

CARTEOLOL HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC CARTEOLOL HYDROCHLORIDE ALCON 1% BAUSCH AND LOMB 1% NOVEX 1% OCUPRESS + NOVARTIS 1%

AT AT AT AT

A075476 001 A075546 001 A076097 001 N019972 001

Jan 03, 2000 Jan 20, 2000 Feb 06, 2002 May 23, 1990

CARVEDILOL
TABLET; ORAL CARVEDILOL APOTEX INC AB AB AB AB AUROBINDO PHARMA AB AB AB AB BEXIMCO USA AB AB AB AB CARACO AB AB AB AB DR REDDYS LABS LTD AB AB AB AB GLENMARK GENERICS AB AB AB AB HIKMA AB

3.125MG 6.25MG 12.5MG 25MG 3.125MG 6.25MG 12.5MG 25MG 3.125MG 6.25MG 12.5MG 25MG 3.125MG 6.25MG 12.5MG 25MG 3.125MG 6.25MG 12.5MG 25MG 3.125MG 6.25MG 12.5MG 25MG 3.125MG

A078165 A078165 A078165 A078165 A078332 A078332 A078332 A078332 A078384 A078384 A078384 A078384 A077346 A077346 A077346 A077346 A076649 A076649 A076649 A076649 A078251 A078251 A078251 A078251 A077887

001 002 003 004 001 002 003 004 001 002 003 004 004 001 002 003 001 002 003 004 001 002 003 004 001

Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep

05, 05, 05, 05, 05, 05, 05, 05, 05, 05, 05, 05, 05, 05, 05, 05, 05, 05, 05, 05, 05, 05, 05, 05, 07,

2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

CARVEDILOL
TABLET; ORAL CARVEDILOL HIKMA AB AB AB LUPIN AB AB AB AB MYLAN AB AB AB AB PLIVA HRVATSKA DOO AB AB AB AB RANBAXY AB AB AB AB SANDOZ AB AB AB AB TARO AB AB AB AB TEVA AB AB AB AB WATSON LABS AB AB AB AB WOCKHARDT AB AB AB AB ZYDUS PHARMS USA INC AB AB AB AB COREG SMITHKLINE BEECHAM AB AB AB + AB

3 - 80 (of 424)

6.25MG 12.5MG 25MG 3.125MG 6.25MG 12.5MG 25MG 3.125MG 6.25MG 12.5MG 25MG 3.125MG 6.25MG 12.5MG 25MG 3.125MG 6.25MG 12.5MG 25MG 3.125MG 6.25MG 12.5MG 25MG 3.125MG 6.25MG 12.5MG 25MG 3.125MG 6.25MG 12.5MG 25MG 3.125MG 6.25MG 12.5MG 25MG 3.125MG 6.25MG 12.5MG 25MG 3.125MG 6.25MG 12.5MG 25MG 3.125MG 6.25MG 12.5MG 25MG

A077887 A077887 A077887 A078217 A078217 A078217 A078217 A077316 A077316 A077316 A077316 A078240 A078240 A078240 A078240 A076989 A076989 A076989 A076989 A078227 A078227 A078227 A078227 A077780 A077780 A077780 A077780 A076373 A076373 A076373 A076373 A077474 A077474 A077474 A077474 A078786 A078786 A078786 A078786 A077614 A077614 A077614 A077614 N020297 N020297 N020297 N020297

002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 004 001 002 003 004 003 002 001

Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Oct Oct Oct Oct Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Dec Dec Dec Dec Sep Sep Sep Sep May Sep Sep Sep

07, 07, 07, 05, 05, 05, 05, 05, 05, 05, 05, 30, 30, 30, 30, 05, 05, 05, 05, 05, 05, 05, 05, 05, 05, 05, 05, 05, 05, 05, 05, 05, 05, 05, 05, 22, 22, 22, 22, 05, 05, 05, 05, 29, 14, 14, 14,

2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2009 2009 2009 2009 2007 2007 2007 2007 1997 1995 1995 1995

CARVEDILOL PHOSPHATE
CAPSULE, EXTENDED RELEASE; ORAL COREG CR SB PHARMCO 10MG XX 20MG XX 40MG XX + 80MG XX

N022012 N022012 N022012 N022012

001 002 003 004

Oct Oct Oct Oct

20, 20, 20, 20,

2006 2006 2006 2006

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

CASPOFUNGIN ACETATE
INJECTABLE; IV (INFUSION)
CANCIDAS
XX + MERCK 50MG/VIAL XX + 70MG/VIAL

3 - 81 (of 424)

N021227 001 N021227 002

Jan 26, 2001 Jan 26, 2001

CEFACLOR
CAPSULE; ORAL CEFACLOR HIKMA AB AB + RANBAXY AB AB YUNG SHIN PHARM AB AB
FOR SUSPENSION; ORAL

CEFACLOR
+ RANBAXY + + +

EQ EQ EQ EQ EQ EQ

250MG 500MG 250MG 500MG 250MG 500MG

BASE BASE BASE BASE BASE BASE

A065350 A065350 A064156 A064156 A065146 A065146

001 002 001 002 001 002

Apr Apr Aug Aug Jan Jan

03, 03, 28, 28, 22, 22,

2007 2007 1997 1997 2004 2004

XX XX XX XX

EQ EQ EQ EQ

125MG 187MG 250MG 375MG

BASE/5ML BASE/5ML BASE/5ML BASE/5ML

A064166 A064165 A064164 A064155

001 001 001 001

Oct Oct Oct Oct

02, 02, 02, 02,

1997 1997 1997 1997

TABLET, CHEWABLE; ORAL RANICLOR RANBAXY XX XX XX XX +

EQ EQ EQ EQ

125MG 187MG 250MG 375MG

BASE BASE BASE BASE

A065092 A065092 A065092 A065092

001 002 003 004

Dec Dec Dec Dec

22, 22, 22, 22,

2003 2003 2003 2003

TABLET, EXTENDED RELEASE; ORAL CEFACLOR TEVA EQ 375MG BASE XX EQ 500MG BASE XX +

A065058 001 A065058 002

Sep 04, 2002 Sep 04, 2002

CEFADROXIL/CEFADROXIL HEMIHYDRATE
CAPSULE; ORAL CEFADROXIL AUROBINDO PHARMA HIKMA LUPIN ORCHID HLTHCARE RANBAXY SANDOZ + TEVA PHARMS

AB AB AB AB AB AB AB

EQ EQ EQ EQ EQ EQ EQ

500MG 500MG 500MG 500MG 500MG 500MG 500MG

BASE BASE BASE BASE BASE BASE BASE

A065352 A065311 A065392 A065309 A065015 A062291 A065282

001 001 001 001 001 001 001

Jan Feb May Sep Jun

25, 07, 29, 18, 22,

2007 2006 2007 2006 1999

Jan 20, 2006

FOR SUSPENSION; ORAL CEFADROXIL LUPIN AB AB + ORCHID HLTHCARE AB AB RANBAXY AB AB TEVA PHARMS AB AB CEFADROXIL RANBAXY XX TABLET; ORAL CEFADROXIL HIKMA AB ORCHID HLTHCARE AB RANBAXY AB

EQ EQ EQ EQ EQ EQ EQ EQ

250MG 500MG 250MG 500MG 250MG 500MG 250MG 500MG

BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML

A065396 A065396 A065307 A065307 A065115 A065115 A065278 A065278

001 002 002 003 002 003 001 002

Feb Feb Oct Oct Mar Mar Jan Jan

21, 21, 16, 16, 26, 26, 20, 20,

2008 2008 2006 2006 2003 2003 2006 2006

EQ 125MG BASE/5ML

A065115 001

Mar 26, 2003

EQ 1GM BASE EQ 1GM BASE EQ 1GM BASE

A065260 001 A065301 001 A065018 001

Mar 30, 2006 Sep 18, 2006 Apr 23, 1999

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

CEFADROXIL/CEFADROXIL HEMIHYDRATE
TABLET; ORAL

CEFADROXIL

XX + IVAX SUB TEVA PHARMS

3 - 82 (of 424)

EQ 1GM BASE

A062774 001

Apr 08, 1987

CEFAZOLIN SODIUM
INJECTABLE; INJECTION CEFAZOLIN SODIUM ACS DOBFAR AP EQ AP EQ AP EQ AP + APP PHARMS EQ AP + EQ AP + EQ AP + EQ AUROBINDO PHARMA AP EQ AP EQ CEPHAZONE PHARMA AP EQ AP EQ AP EQ AP EQ HIKMA FARMACEUTICA AP EQ AP EQ AP EQ HOSPIRA INC AP EQ AP EQ AP EQ AP EQ SANDOZ AP EQ AP EQ AP EQ AP EQ STERI PHARMA AP EQ AP EQ AP EQ AP EQ AP EQ AP EQ KEFZOL ACS DOBFAR AP EQ AP EQ AP EQ ANCEF IN PLASTIC CONTAINER EQ XX + BAXTER HLTHCARE EQ XX + CEFAZOLIN AND DEXTROSE EQ XX + B BRAUN CEFAZOLIN SODIUM EQ XX + SAMSON MEDCL EQ XX +

500MG BASE/VIAL 1GM BASE/VIAL 10GM BASE/VIAL 500MG BASE/VIAL 1GM BASE/VIAL 10GM BASE/VIAL 20GM BASE/VIAL 500MG BASE/VIAL 1GM BASE/VIAL 500MG BASE/VIAL 1GM BASE/VIAL 10GM BASE/VIAL 20GM BASE/VIAL 500MG BASE/VIAL 1GM BASE/VIAL 10GM BASE/VIAL 500MG BASE/VIAL 1GM BASE/VIAL 1GM BASE/VIAL 10GM BASE/VIAL 500MG BASE/VIAL 1GM BASE/VIAL 1GM BASE/VIAL 10GM BASE/VIAL 500MG BASE/VIAL 500MG BASE/VIAL 1GM BASE/VIAL 1GM BASE/VIAL 10GM BASE/VIAL 20GM BASE/VIAL 500MG BASE/VIAL 1GM BASE/VIAL 10GM BASE/VIAL 10MG BASE/ML 20MG BASE/ML 1GM BASE/VIAL 100GM BASE/VIAL 300GM BASE/VIAL

A065303 A065303 A065306 A064169 A064169 A064170 A064170 A065395 A065395 A065280 A065280 A065295 A065296 A065047 A065047 A065143 A065226 A065226 A065244 A065247 A062831 A062831 A065345 A062831 A063214 A063216 A063207 A063208 A063209 A063209

001 002 001 001 002 001 002 001 002 001 002 001 001 001 002 001 001 002 001 001 001 002 001 003 001 001 001 001 001 002

Oct Oct Oct Aug Aug Mar Mar Aug Aug Mar Mar Mar Mar Sep Sep Oct Apr Apr Aug Aug Dec Dec May Sep Dec Dec Dec Dec Dec Apr

22, 22, 22, 14, 14, 18, 18, 08, 08, 18, 18, 18, 18, 18, 18, 18, 21, 21, 12, 12, 09, 09, 09, 25, 27, 27, 27, 27, 27, 30,

2008 2008 2008 1998 1998 1998 1998 2008 2008 2009 2009 2009 2009 2001 2001 2004 2005 2005 2005 2005 1988 1988 2007 1992 1991 1991 1991 1991 1991 1999

A061773 002 A061773 003 A061773 004 A063002 001 A063002 002 N050779 002 A065141 001 A065141 002 Mar 28, 1991 Mar 28, 1991 Jul 27, 2000 Nov 29, 2006 Nov 29, 2006

CEFDINIR
CAPSULE; ORAL CEFDINIR AUROBINDO PHARMA LUPIN ORCHID HLTHCARE + SANDOZ TEVA PHARMS

AB AB AB AB AB

300MG 300MG 300MG 300MG 300MG

A065434 A065264 A065418 A065330 A065368

001 001 001 001 001

Jan May Jul Apr May

07, 19, 18, 06, 09,

2008 2006 2007 2007 2007

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

CEFDINIR
FOR SUSPENSION; ORAL CEFDINIR AUROBINDO PHARMA AB AB LUPIN AB AB ORCHID HLTHCARE AB AB SANDOZ AB AB + TEVA PHARMS AB AB

3 - 83 (of 424)

125MG/5ML 250MG/5ML 125MG/5ML 250MG/5ML 125MG/5ML 250MG/5ML 125MG/5ML 250MG/5ML 125MG/5ML 250MG/5ML

A065473 A065473 A065259 A065259 A065429 A065429 A065337 A065337 A065332 A065332

001 002 001 002 001 002 001 002 001 002

Dec Dec May May Jul Jul Apr Apr May May

14, 14, 31, 07, 18, 18, 06, 06, 04, 04,

2007 2007 2006 2007 2007 2007 2007 2007 2007 2007

CEFDITOREN PIVOXIL
TABLET; ORAL SPECTRACEF CORNERSTONE THERAP XX XX +

200MG 400MG

N021222 001 N021222 002

Aug 29, 2001 Jul 21, 2008

CEFEPIME HYDROCHLORIDE
INJECTABLE; INJECTION CEFEPIME HYDROCHLORIDE ACS DOBFAR AP EQ 1GM BASE/VIAL AP EQ 2GM BASE/VIAL HOSPIRA INC AP EQ 500MG BASE/VIAL AP EQ 1GM BASE/VIAL AP EQ 2GM BASE/VIAL SANDOZ AP EQ 500MG BASE/VIAL AP EQ 1GM BASE/VIAL AP EQ 2GM BASE/VIAL MAXIPIME AP + HOSPIRA INC EQ 500MG BASE/VIAL AP + EQ 1GM BASE/VIAL AP + EQ 2GM BASE/VIAL CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER B BRAUN EQ 1GM BASE/VIAL XX EQ 2GM BASE/VIAL XX CEFEPIME IN PLASTIC CONTAINER EQ 1GM BASE/50ML (EQ 20MG BASE/ML) XX + BAXTER HLTHCARE EQ 2GM BASE/100ML (EQ 20MG BASE/ML) XX +

A065441 A065441 A065369 A065369 A065369 A090291 A090291 A090291

001 002 001 002 003 001 002 003

Mar Mar Jun Jun Jun Dec Dec Dec

20, 20, 18, 18, 18, 21, 21, 21,

2008 2008 2007 2007 2007 2010 2010 2010

N050679 001 N050679 002 N050679 003 N050821 001 N050821 002 N050817 001 N050817 002

Jan 18, 1996 Jan 18, 1996 Jan 18, 1996 May 06, 2010 May 06, 2010 Aug 05, 2008 Aug 05, 2008

CEFIXIME
SUSPENSION; ORAL SUPRAX LUPIN PHARMS XX XX +
TABLET; ORAL

SUPRAX
XX + LUPIN PHARMS TABLET, CHEWABLE; ORAL SUPRAX LUPIN LTD XX XX XX +

100MG/5ML 200MG/5ML

A065129 001 A065355 001

Feb 23, 2004 Apr 10, 2007

400MG

A065130 001

Feb 12, 2004

100MG 150MG 200MG

A065380 001 A065380 002 A065380 003

Oct 25, 2010 Oct 25, 2010 Oct 25, 2010

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

CEFOTAXIME SODIUM
INJECTABLE; INJECTION CEFOTAXIME APP PHARMS AP EQ 500MG BASE/VIAL AP EQ 1GM BASE/VIAL AP EQ 2GM BASE/VIAL AP EQ 10GM BASE/VIAL HIKMA AP EQ 500MG BASE/VIAL AP EQ 1GM BASE/VIAL AP EQ 2GM BASE/VIAL AP EQ 10GM BASE/VIAL WOCKHARDT AP EQ 1GM BASE/VIAL CEFOTAXIME SODIUM AUROBINDO PHARMA AP EQ 500MG BASE/VIAL AP EQ 1GM BASE/VIAL AP EQ 2GM BASE/VIAL AP EQ 10GM BASE/VIAL CEPHAZONE PHARMA AP EQ 10GM BASE/VIAL HOSPIRA INC AP EQ 500MG BASE/VIAL AP EQ 1GM BASE/VIAL AP EQ 1GM BASE/VIAL AP EQ 2GM BASE/VIAL AP EQ 2GM BASE/VIAL AP EQ 10GM BASE/VIAL LUPIN AP EQ 500MG BASE/VIAL AP EQ 1GM BASE/VIAL AP EQ 2GM BASE/VIAL WOCKHARDT AP EQ 500MG BASE/VIAL AP EQ 2GM BASE/VIAL CLAFORAN AP + SANOFI AVENTIS US EQ 500MG BASE/VIAL AP EQ 1GM BASE/VIAL AP + EQ 1GM BASE/VIAL AP EQ 2GM BASE/VIAL AP + EQ 2GM BASE/VIAL AP + EQ 10GM BASE/VIAL CEFOTAXIME EQ 20GM BASE/VIAL XX + APP PHARMS CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 20MG BASE/ML XX + SANOFI AVENTIS US EQ 40MG BASE/ML XX +

3 - 84 (of 424)

A064200 A064200 A064200 A064201 A065072 A065072 A065072 A065071 A065197 A065517 A065517 A065517 A065516 A065348 A065290 A065290 A065293 A065290 A065293 A065292 A065124 A065124 A065124 A065197 A065197 N050547 A062659 N050547 A062659 N050547 N050547

001 002 003 001 001 002 003 001 001 001 002 003 001 001 001 002 001 003 002 001 001 002 003 002 003 001 001 002 002 003 004

Mar Mar Mar Mar Nov Nov Nov Nov Aug Nov Nov Nov Nov Jan Aug Aug Aug Aug Aug Aug Sep Sep Sep Jun Jun

24, 24, 24, 24, 20, 20, 20, 20, 29, 06, 06, 06, 06, 25, 11, 11, 10, 11, 10, 10, 24, 24, 24, 20, 20,

2000 2000 2000 2000 2002 2002 2002 2002 2006 2009 2009 2009 2009 2010 2006 2006 2006 2006 2006 2006 2003 2003 2003 2008 2008

Jan 13, 1987 Jan 13, 1987 Dec 29, 1983 Mar 24, 2000 May 20, 1985 May 20, 1985

A064201 002 N050596 002 N050596 004

CEFOTETAN DISODIUM
INJECTABLE; INJECTION CEFOTETAN + APP PHARMS + + WEST-WARD PHARM CORP

AP AP AP AP AP AP XX XX

EQ 1GM BASE/VIAL EQ 2GM BASE/VIAL EQ 10GM BASE/VIAL EQ 1GM BASE/VIAL EQ 2GM BASE/VIAL EQ 10GM BASE/VIAL CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER + B BRAUN EQ 1GM BASE/VIAL + EQ 2GM BASE/VIAL

A065374 A065374 A065375 A091031 A091031 A091030

001 002 001 001 002 001

Aug Aug Aug Oct Oct Oct

09, 09, 09, 26, 26, 26,

2007 2007 2007 2011 2011 2011

A065430 001 A065430 002

Aug 09, 2007 Aug 09, 2007

CEFOXITIN
INJECTABLE; INJECTION CEFOXITIN ANTIBIOTICOS BRASIL AP AP

EQ 1GM BASE/VIAL EQ 2GM BASE/VIAL

A065467 001 A065467 002

Aug 31, 2011 Aug 31, 2011

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

CEFOXITIN
INJECTABLE; INJECTION CEFOXITIN ANTIBIOTICOS BRASIL AP

3 - 85 (of 424)

EQ 10GM BASE/VIAL

A065464 001

Aug 31, 2011

CEFOXITIN SODIUM
INJECTABLE; INJECTION CEFOXITIN ACS DOBFAR AP EQ 1GM BASE/VIAL AP EQ 2GM BASE/VIAL AP EQ 10GM BASE/VIAL AP + APP PHARMS EQ 1GM BASE/VIAL AP + EQ 2GM BASE/VIAL AP + EQ 10GM BASE/VIAL BAXTER HLTHCARE AP EQ 1GM BASE/VIAL AP EQ 2GM BASE/VIAL AP EQ 10GM BASE/VIAL HIKMA FARMACEUTICA AP EQ 1GM BASE/VIAL AP EQ 2GM BASE/VIAL AP EQ 10GM BASE/VIAL HOSPIRA INC AP EQ 1GM BASE/VIAL AP EQ 2GM BASE/VIAL AP EQ 10GM BASE/VIAL CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER B BRAUN AP EQ 1GM BASE/VIAL AP EQ 2GM BASE/VIAL MEFOXIN IN PLASTIC CONTAINER EQ 20MG BASE/ML XX + BIONICHE PHARMA EQ 40MG BASE/ML XX +

A065414 A065414 A065415 A065012 A065012 A065011 A065051 A065051 A065050 A065238 A065238 A065239 A065313 A065313 A065312

001 002 001 001 002 001 001 002 001 001 002 001 001 002 001

Jun Jun May Jul Jul Jul Sep Sep Sep Mar Mar Mar Jan Jan Feb

12, 12, 19, 03, 03, 03, 11, 11, 11, 12, 12, 02, 23, 23, 13,

2009 2009 2010 2000 2000 2000 2000 2000 2000 2010 2010 2010 2006 2006 2006

A065214 001 A065214 002 A063182 001 A063182 002

Mar 10, 2006 Mar 10, 2006 Jan 25, 1993 Jan 25, 1993

CEFPODOXIME PROXETIL
FOR SUSPENSION; ORAL CEFPODOXIME PROXETIL AUROBINDO PHARMA AB AB + RANBAXY AB AB SANDOZ AB AB TABLET; ORAL CEFPODOXIME PROXETIL AUROBINDO PHARMA AB AB ORCHID HLTHCARE AB AB RANBAXY AB AB SANDOZ AB AB +

EQ EQ EQ EQ EQ EQ

50MG BASE/5ML 100MG BASE/5ML 50MG BASE/5ML 100MG BASE/5ML 50MG BASE/5ML 100MG BASE/5ML

A065409 A065409 A065082 A065082 A090031 A090031

001 002 001 002 001 002

Jun Jun May May Jan Jan

08, 08, 31, 31, 14, 14,

2007 2007 2002 2002 2009 2009

EQ EQ EQ EQ EQ EQ EQ EQ

100MG 200MG 100MG 200MG 100MG 200MG 100MG 200MG

BASE BASE BASE BASE BASE BASE BASE BASE

A065370 A065370 A065388 A065388 A065083 A065083 A065462 A065462

001 002 001 002 001 002 001 002

Jun Jun Nov Nov Aug Aug May May

11, 11, 14, 14, 20, 20, 28, 28,

2007 2007 2007 2007 2003 2003 2008 2008

CEFPROZIL
FOR SUSPENSION; ORAL CEFPROZIL AUROBINDO PHARMA AB AB LUPIN AB AB + ORCHID HLTHCARE AB AB RANBAXY AB

125MG/5ML 250MG/5ML 125MG/5ML 250MG/5ML 125MG/5ML 250MG/5ML 125MG/5ML

A065381 A065381 A065261 A065261 A065284 A065284 A065202

001 002 001 002 002 001 001

Jan Jan Dec Dec Dec Dec Jun

30, 30, 19, 19, 30, 30, 30,

2007 2007 2005 2005 2005 2005 2006

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

CEFPROZIL
FOR SUSPENSION; ORAL CEFPROZIL RANBAXY AB SANDOZ AB AB TEVA PHARMS AB AB TABLET; ORAL CEFPROZIL APOTEX INC AB AB AUROBINDO PHARMA LTD AB AB LUPIN AB AB + ORCHID HLTHCARE AB AB RANBAXY AB AB SANDOZ AB AB TEVA AB AB WOCKHARDT AB AB

3 - 86 (of 424)

250MG/5ML 125MG/5ML 250MG/5ML 125MG/5ML 250MG/5ML

A065202 A065257 A065257 A065236 A065236

002 001 002 001 002

Jun Dec Dec Dec Dec

30, 08, 08, 08, 08,

2006 2005 2005 2005 2005

250MG 500MG 250MG 500MG 250MG 500MG 250MG 500MG 250MG 500MG 250MG 500MG 250MG 500MG 250MG 500MG

A065327 A065327 A065340 A065340 A065276 A065276 A065267 A065267 A065198 A065198 A065235 A065235 A065208 A065208 A065428 A065428

001 002 001 002 001 002 001 002 001 002 001 002 001 002 001 002

Mar Mar May May Dec Dec Dec Dec Dec Dec Nov Nov Dec Dec Jun Jun

26, 26, 24, 24, 08, 08, 19, 19, 13, 13, 14, 14, 06, 06, 14, 14,

2008 2008 2007 2007 2005 2005 2005 2005 2006 2006 2005 2005 2005 2005 2007 2007

CEFTAROLINE FOSAMIL
POWDER; IV (INFUSION) TEFLARO CEREXA XX XX +

400MG/VIAL 600MG/VIAL

N200327 001 N200327 002

Oct 29, 2010 Oct 29, 2010

CEFTAZIDIME
INJECTABLE; INJECTION CEFTAZIDIME ACS DOBFAR AP AP AP AP AUROBINDO PHARMA AP AP AP AP WOCKHARDT AP FORTAZ AP + GLAXOSMITHKLINE AP + AP + AP + TAZICEF HOSPIRA AP AP AP AP AP AP CEFTAZIDIME IN DEXTROSE B BRAUN XX XX +

500MG/VIAL 1GM/VIAL 2GM/VIAL 6GM/VIAL 500MG/VIAL 1GM/VIAL 2GM/VIAL 6GM/VIAL 1GM/VIAL 500MG/VIAL 1GM/VIAL 2GM/VIAL 6GM/VIAL 500MG/VIAL 1GM/VIAL 1GM/VIAL 2GM/VIAL 2GM/VIAL 6GM/VIAL CONTAINER EQ 1GM BASE EQ 2GM BASE

A062640 A062640 A062640 A062640 A065481 A065481 A065481 A065482 A065196 N050578 N050578 N050578 N050578 A062662 A062662 A064032 A062662 A064032 A062662

001 002 003 004 001 002 003 001 001 001 002 003 004 001 002 001 003 002 004

Nov Nov Nov Feb May May May May Oct Jul Jul Jul Jul Mar Mar Oct Mar Oct Mar

20, 20, 20, 03, 28, 28, 28, 28, 15, 19, 19, 19, 19, 06, 06, 31, 06, 31, 06,

1985 1985 1985 1992 2010 2010 2010 2010 2008 1985 1985 1985 1985 1986 1986 1993 1986 1993 1986

N050823 001 N050823 002

Jun 13, 2011 Jun 13, 2011

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

CEFTAZIDIME SODIUM
INJECTABLE; INJECTION

FORTAZ IN PLASTIC CONTAINER

EQ 20MG BASE/ML XX + GLAXOSMITHKLINE EQ 40MG BASE/ML XX +

3 - 87 (of 424)

N050634 002 N050634 003

Apr 28, 1989 Apr 28, 1989

CEFTIBUTEN DIHYDRATE

CAPSULE; ORAL

CEDAX
XX + PERNIX THERAP
FOR SUSPENSION; ORAL

CEDAX
XX + PERNIX THERAP

EQ 400MG BASE

N050685 002

Dec 20, 1995

EQ 90MG BASE/5ML

N050686 001

Dec 20, 1995

CEFTRIAXONE SODIUM
INJECTABLE; IM-IV CEFTRIAXONE APP PHARMS AP AP AP AP AUROBINDO PHARMA AP AP AP AP BEDFORD AP AP AP AP CEPHAZONE PHARMA AP AP AP AP HIKMA FARMACEUTICA AP AP AP AP HOSPIRA INC AP AP AP AP LUITPOLD AP AP AP AP LUPIN AP AP AP AP AP + SANDOZ AP + AP + AP + STERI PHARMA AP AP TEVA AP AP TEVA PARENTERAL AP AP AP

EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ

250MG BASE/VIAL 500MG BASE/VIAL 1GM BASE/VIAL 2GM BASE/VIAL 250MG BASE/VIAL 500MG BASE/VIAL 1GM BASE/VIAL 2GM BASE/VIAL 250MG BASE/VIAL 500MG BASE/VIAL 1GM BASE/VIAL 2GM BASE/VIAL 250MG BASE/VIAL 500MG BASE/VIAL 1GM BASE/VIAL 2GM BASE/VIAL 250MG BASE/VIAL 500MG BASE/VIAL 1GM BASE/VIAL 2GM BASE/VIAL 250MG BASE/VIAL 500MG BASE/VIAL 1GM BASE/VIAL 2GM BASE/VIAL 250MG BASE/VIAL 500MG BASE/VIAL 1GM BASE/VIAL 2GM BASE/VIAL 250MG BASE/VIAL 500MG BASE/VIAL 1GM BASE/VIAL 2GM BASE/VIAL 250MG BASE/VIAL 500MG BASE/VIAL 1GM BASE/VIAL 2GM BASE/VIAL 1GM BASE/VIAL 2GM BASE/VIAL 1GM BASE/VIAL 2GM BASE/VIAL 250MG BASE/VIAL 500MG BASE/VIAL 1GM BASE/VIAL

A065245 A065245 A065245 A065245 A065505 A065505 A065505 A065505 A065465 A065465 A065465 A065465 A065294 A065294 A065294 A065294 A065342 A065342 A065342 A065342 A065230 A065230 A065230 A065230 A065305 A065305 A065305 A065305 A065125 A065125 A065125 A065125 A065169 A065169 A065169 A065169 A065268 A065268 A065262 A065262 A065227 A065227 A065227

001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 001 002 001 002 003

Feb Feb Feb Feb Jul Jul Jul Jul Aug Aug Aug Aug Mar Mar Mar Mar Jan Jan Jan Jan Aug Aug Aug Aug Jan Jan Jan Jan Sep Sep Sep Sep May May May May Feb Feb Jun Jun Mar Mar Mar

15, 15, 15, 15, 31, 31, 31, 31, 18, 18, 18, 18, 26, 26, 26, 26, 10, 10, 10, 10, 02, 02, 02, 02, 11, 11, 11, 11, 30, 30, 30, 30, 09, 09, 09, 09, 28, 28, 29, 29, 15, 15, 15,

2006 2006 2006 2006 2008 2008 2008 2008 2008 2008 2008 2008 2007 2007 2007 2007 2008 2008 2008 2008 2005 2005 2005 2005 2008 2008 2008 2008 2003 2003 2003 2003 2005 2005 2005 2005 2007 2007 2006 2006 2007 2007 2007

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

CEFTRIAXONE SODIUM
INJECTABLE; IM-IV CEFTRIAXONE TEVA PARENTERAL AP WOCKHARDT AP AP AP

3 - 88 (of 424)

EQ EQ EQ EQ

2GM BASE/VIAL 250MG BASE/VIAL 500MG BASE/VIAL 2GM BASE/VIAL

A065227 A065391 A065391 A065391

004 001 002 003

Mar Apr Apr Apr

15, 12, 12, 12,

2007 2007 2007 2007

INJECTABLE; INJECTION CEFTRIAXONE ACS DOBFAR AP EQ 500MG BASE/VIAL AP EQ 1GM BASE/VIAL AP EQ 2GM BASE/VIAL AP EQ 10GM BASE/VIAL APP PHARMS AP EQ 10GM BASE/VIAL AUROBINDO PHARMA AP EQ 10GM BASE/VIAL BEDFORD AP EQ 10GM BASE/VIAL HOSPIRA INC AP EQ 1GM BASE/VIAL AP EQ 2GM BASE/VIAL AP EQ 10GM BASE/VIAL LUPIN AP EQ 10GM BASE/VIAL SANDOZ AP EQ 1GM BASE/VIAL AP EQ 2GM BASE/VIAL AP + EQ 10GM BASE/VIAL STERI PHARMA AP EQ 10GM BASE/VIAL TEVA AP EQ 10GM BASE/VIAL WOCKHARDT AP EQ 1GM BASE/VIAL CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER AP + B BRAUN EQ 1GM BASE/VIAL AP + EQ 2GM BASE/VIAL ROCEPHIN AP + HOFFMANN LA ROCHE EQ 500MG BASE/VIAL AP + EQ 1GM BASE/VIAL CEFTRIAXONE IN PLASTIC CONTAINER BAXTER HLTHCARE EQ 20MG BASE/ML XX EQ 40MG BASE/ML XX

A065329 A065329 A065329 A065328 A065252 A065504 A065475 A065231 A065231 A065232 A065263 A065204 A065204 A065168 A065269 A065274 A065180

001 002 003 001 001 001 001 001 002 001 001 001 002 001 001 001 001

Jul Jul Jul Jul Feb Jul Aug Aug Aug Aug Sep May May May Feb May May

24, 24, 24, 24, 15, 31, 18, 02, 02, 02, 12, 03, 03, 17, 28, 01, 12,

2008 2008 2008 2008 2006 2008 2008 2005 2005 2005 2006 2005 2005 2005 2007 2006 2006

N050796 001 N050796 002 A063239 002 A063239 003 A065224 001 A065224 002

Apr 20, 2005 Apr 20, 2005 Aug 13, 1993 Aug 13, 1993 Aug 23, 2005 Aug 23, 2005

CEFUROXIME AXETIL
FOR SUSPENSION; ORAL CEFTIN GLAXOSMITHKLINE AB AB + CEFUROXIME AXETIL RANBAXY AB AB TABLET; ORAL CEFTIN GLAXOSMITHKLINE AB AB AB + CEFUROXIME AXETIL ALKEM LABS LTD AB AB APOTEX AB AB AUROBINDO PHARMA LTD AB AB AB LUPIN AB AB ORCHID HLTHCARE AB

EQ 125MG BASE/5ML EQ 250MG BASE/5ML EQ 125MG BASE/5ML EQ 250MG BASE/5ML

N050672 001 N050672 002 A065323 001 A065323 002

Jun 30, 1994 Apr 29, 1997 Feb 05, 2008 Feb 05, 2008

EQ 125MG BASE EQ 250MG BASE EQ 500MG BASE EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ 250MG 500MG 250MG 500MG 125MG 250MG 500MG 250MG 500MG 125MG BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE

N050605 001 N050605 002 N050605 003 A065496 A065496 A065069 A065069 A065308 A065308 A065308 A065135 A065135 A065359 001 002 001 002 001 002 003 001 002 001

Dec 28, 1987 Dec 28, 1987 Dec 28, 1987 Jun Jun Oct Oct Mar Mar Mar Jul Jul Feb 07, 07, 02, 02, 29, 29, 29, 25, 25, 15, 2010 2010 2002 2002 2006 2006 2006 2003 2003 2008

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

CEFUROXIME AXETIL
TABLET; ORAL CEFUROXIME AXETIL ORCHID HLTHCARE AB AB RANBAXY AB AB AB AB AB AB TEVA AB AB WOCKHARDT AB AB AB

3 - 89 (of 424)

EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ

250MG 500MG 125MG 125MG 250MG 250MG 500MG 500MG 250MG 500MG 125MG 250MG 500MG

BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE

A065359 A065359 A065043 A065118 A065043 A065118 A065043 A065118 A065190 A065190 A065166 A065166 A065166

002 003 003 001 002 002 001 003 001 002 001 002 003

Feb Feb Feb Apr Feb Apr Feb Apr Oct Oct Jul Jul Jul

15, 15, 15, 25, 15, 25, 15, 25, 18, 18, 29, 29, 29,

2008 2008 2002 2003 2002 2003 2002 2003 2004 2004 2005 2005 2005

CEFUROXIME SODIUM
INJECTABLE; IM-IV CEFUROXIME SODIUM APP PHARMS HIKMA FARMACEUTICA STERI PHARMA TEVA ZINACEF + GLAXOSMITHKLINE CEFUROXIME SODIUM HOSPIRA INC

AB AB AB AB AB AP

EQ EQ EQ EQ

750MG 750MG 750MG 750MG

BASE/VIAL BASE/VIAL BASE/VIAL BASE/VIAL

A065001 A065048 A064125 A064192

001 001 001 002

May Jan May Apr

30, 09, 30, 16,

2001 2004 1997 1998

EQ 750MG BASE/VIAL EQ 750MG BASE/VIAL

N050558 002 A065483 001

Oct 19, 1983 Oct 15, 2008

INJECTABLE; INJECTION CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER AP + B BRAUN EQ 750MG BASE/VIAL AP + EQ 1.5GM BASE/VIAL CEFUROXIME SODIUM APP PHARMS AP EQ 1.5GM BASE/VIAL AP EQ 7.5GM BASE/VIAL HIKMA FARMACEUTICA AP EQ 1.5GM BASE/VIAL AP EQ 7.5GM BASE/VIAL HOSPIRA INC AP EQ 1.5GM BASE/VIAL AP EQ 1.5GM BASE/VIAL AP EQ 7.5GM BASE/VIAL STERI PHARMA AP EQ 1.5GM BASE/VIAL AP EQ 7.5GM BASE/VIAL TEVA AP EQ 1.5GM BASE/VIAL AP EQ 7.5GM BASE/VIAL ZINACEF AP + GLAXOSMITHKLINE EQ 1.5GM BASE/VIAL AP + EQ 7.5GM BASE/VIAL CEFUROXIME SODIUM IN PLASTIC CONTAINER EQ 75GM BASE/VIAL XX + SAMSON MEDCL EQ 225GM BASE/VIAL XX + ZINACEF IN PLASTIC CONTAINER EQ 15MG BASE/ML XX + GLAXOSMITHKLINE EQ 30MG BASE/ML XX +

N050780 001 N050780 002 A065001 A065002 A065048 A065046 A065483 A065503 A065484 A064125 A064124 A064192 A064191 002 001 002 001 002 001 001 002 001 001 001

Feb 21, 2001 Feb 21, 2001 May Sep Jan Jan Oct Oct Oct May May Apr Apr 30, 28, 09, 09, 15, 15, 15, 30, 30, 16, 16, 2001 1998 2004 2004 2008 2008 2008 1997 1997 1998 1998

N050558 003 N050558 004 A065251 001 A065251 002 N050643 001 N050643 002

Oct 19, 1983 Oct 23, 1986 Dec 30, 2009 Dec 30, 2009 Apr 28, 1989 Apr 28, 1989

CELECOXIB
CAPSULE; ORAL CELEBREX GD SEARLE XX XX XX

50MG 100MG 200MG

N020998 004 N020998 001 N020998 002

Dec 15, 2006 Dec 31, 1998 Dec 31, 1998

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

CELECOXIB
CAPSULE; ORAL

CELEBREX

XX + GD SEARLE

3 - 90 (of 424)

400MG

N020998 003

Aug 29, 2002

CEPHALEXIN
CAPSULE; ORAL CEPHALEXIN ALKEM AB AB AUROBINDO PHARMA LTD AB AB BELCHER PHARMS AB AB FACTA FARMA AB AB HIKMA AB AB LUPIN AB AB ORCHID HLTHCARE AB AB RANBAXY AB AB STEVENS J AB SUN PHARM INDS (IN) AB AB TEVA AB AB YUNG SHIN PHARM AB AB KEFLEX SHIONOGI INC AB AB KEFLEX XX + SHIONOGI INC FOR SUSPENSION; ORAL CEPHALEXIN FACTA FARMA AB AB + HIKMA PHARMS AB AB LUPIN AB AB ORCHID HLTHCARE AB AB RANBAXY AB AB TEVA AB AB YUNG SHIN PHARM AB AB TABLET; ORAL
CEPHALEXIN
TEVA
XX XX +

EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ

250MG 500MG 250MG 500MG 250MG 500MG 250MG 500MG 250MG 500MG 250MG 500MG 250MG 500MG 250MG 500MG 250MG 250MG 500MG 250MG 500MG 250MG 500MG

BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE

A090836 A090836 A065253 A065253 A062713 A062713 A062118 A062118 A065215 A065215 A065229 A065229 A065248 A065248 A065007 A065007 A062870 A062791 A062791 A062702 A062702 A065152 A065152

001 002 001 002 001 002 001 002 001 002 001 002 001 002 001 002 001 001 002 001 002 001 002

Dec Dec Nov Nov Jul Jul

20, 20, 16, 16, 15, 15,

2010 2010 2005 2005 1988 1988

Jan Jan Nov Nov Jun Jun Sep Sep Mar Jun Jun Feb Feb Feb Feb

24, 24, 25, 25, 28, 28, 16, 16, 17, 11, 11, 13, 13, 24, 24,

2006 2006 2005 2005 2005 2005 1999 1999 1988 1987 1987 1987 1987 2005 2005

EQ 250MG BASE EQ 500MG BASE EQ 750MG BASE

N050405 002 N050405 003 N050405 005 May 12, 2006

EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ

125MG 250MG 125MG 250MG 125MG 250MG 125MG 250MG 125MG 250MG 125MG 250MG 125MG 250MG

BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML

A062117 A062117 A065444 A065444 A065234 A065234 A065326 A065326 A065081 A065081 A062703 A062703 A065336 A065336

002 003 001 002 001 002 001 002 001 002 001 002 001 002

Aug Aug Aug Aug Jul Jul Jul Jul Feb Feb Jul Jul

28, 28, 17, 17, 10, 10, 27, 27, 13, 13, 25, 25,

2009 2009 2005 2005 2006 2006 2001 2001 1987 1987 2007 2007

EQ 250MG BASE EQ 500MG BASE

A063023 001 A063024 001

Jan 12, 1989 Jan 12, 1989

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

CETIRIZINE HYDROCHLORIDE
SYRUP; ORAL CETIRIZINE HYDROCHLORIDE AMNEAL PHARMS 5MG/5ML APOTEX INC 5MG/5ML AUROBINDO PHARMA 5MG/5ML CYPRESS PHARM 5MG/5ML DR REDDYS LABS LTD 5MG/5ML PERRIGO R AND D 5MG/5ML RANBAXY 5MG/5ML SUN PHARM INDS INC 5MG/5ML TARO 5MG/5ML TEVA PHARMS 5MG/5ML VINTAGE 5MG/5ML WOCKHARDT 5MG/5ML ZYRTEC + MCNEIL CONSUMER 5MG/5ML

3 - 91 (of 424)

AA AA AA AA AA AA AA AA AA AA AA AA AA

A090766 A078412 A090751 A078488 A078870 A078398 A077472 A090191 A076601 A077279 A078496 A078757

001 001 001 001 001 001 001 001 001 001 001 001

Oct Jun Dec Oct Apr Jun Jun Nov Jun May Sep Aug

07, 18, 16, 06, 27, 17, 18, 12, 20, 27, 25, 28,

2009 2008 2009 2008 2009 2008 2008 2009 2008 2008 2009 2009

N020346 001

Sep 27, 1996

CETRORELIX
INJECTABLE; INJECTION

CETROTIDE

XX + EMD SERONO XX +

EQ 0.25MG BASE/ML EQ 3MG BASE/ML

N021197 001 N021197 002

Aug 11, 2000 Aug 11, 2000

CEVIMELINE HYDROCHLORIDE
CAPSULE; ORAL CEVIMELINE APOTEX INC AB EVOXAC AB + DAIICHI SANKYO CO

30MG 30MG

A091260 001 N020989 002

Aug 25, 2011 Jan 11, 2000

CHENODIOL
TABLET; ORAL

CHENODIOL

XX + NEXGEN PHARMA

250MG

A091019 001

Oct 22, 2009

CHLORAMBUCIL

TABLET; ORAL

LEUKERAN
XX + PBS

2MG

N010669 002

CHLORAMPHENICOL SODIUM SUCCINATE

INJECTABLE; INJECTION

CHLORAMPHENICOL SODIUM SUCCINATE
EQ 1GM BASE/VIAL XX + APP PHARMS

A062365 001

Aug 25, 1982

CHLORDIAZEPOXIDE HYDROCHLORIDE
CAPSULE; ORAL CHLORDIAZEPOXIDE HYDROCHLORIDE BARR AB 5MG AB 10MG AB 25MG USL PHARMA AB 10MG WATSON LABS AB 5MG AB 10MG AB 25MG LIBRIUM VALEANT PHARM INTL AB 5MG AB 10MG

A084768 A083116 A084769 A084623 A086383 A086294 A086382

001 001 001 001 001 001 001

A085461 001 A085472 001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

CHLORDIAZEPOXIDE HYDROCHLORIDE
CAPSULE; ORAL LIBRIUM AB + VALEANT PHARM INTL

3 - 92 (of 424)

25MG

A085475 001

CHLORHEXIDINE GLUCONATE
SOLUTION; DENTAL CHLORHEXIDINE GLUCONATE HI TECH PHARMA JOHN O BUTLER CO LYNE NOVEX TEVA WOCKHARDT XTTRIUM PERIDEX + 3M PERIOGARD COLGATE

AT AT AT AT AT AT AT AT AT

0.12% 0.12% 0.12% 0.12% 0.12% 0.12% 0.12% 0.12% 0.12%

A074356 A076434 A074291 A075561 A074522 A075006 A077789

001 001 001 001 001 001 001

May Nov Dec Nov Dec Mar Jun

07, 29, 28, 14, 15, 03, 18,

1996 2005 1995 2000 1995 2004 2009

N019028 001 A073695 001

Aug 13, 1986 Jan 14, 1994

TABLET; DENTAL
PERIOCHIP
XX + DEXCEL PHARMA

2.5MG

N020774 001

May 15, 1998

CHLOROPROCAINE HYDROCHLORIDE
INJECTABLE; INJECTION CHLOROPROCAINE HYDROCHLORIDE BEDFORD 2% 3% HOSPIRA 2% 3% NESACAINE APP PHARMS 2% NESACAINE-MPF + APP PHARMS 2% + 3% NESACAINE + APP PHARMS 1%

AP AP AP AP AP AP AP XX

A040273 A040273 A087447 A087446

001 002 001 001

Sep Sep Apr Apr

09, 09, 16, 16,

1998 1998 1982 1982

N009435 002 N009435 006 N009435 007 N009435 001 May 02, 1996 May 02, 1996

CHLOROQUINE PHOSPHATE
TABLET; ORAL ARALEN AA + SANOFI AVENTIS US CHLOROQUINE PHOSPHATE IMPAX LABS AA AA IPCA LABS LTD AA AA NATCO PHARMA LTD AA AA AA + WEST WARD AA

EQ 300MG BASE EQ EQ EQ EQ EQ EQ EQ EQ 150MG 300MG 150MG 300MG 150MG 300MG 150MG 300MG BASE BASE BASE BASE BASE BASE BASE BASE

N006002 001 A080880 A040516 A090610 A090249 A091621 A090612 A083082 A083082 001 001 001 001 001 001 001 002

Aug Dec Dec Jan Jan

29, 03, 03, 21, 21,

2003 2009 2009 2011 2011

Sep 17, 1999

CHLOROTHIAZIDE
SUSPENSION; ORAL
DIURIL
XX + SALIX PHARMS TABLET; ORAL CHLOROTHIAZIDE AB + MYLAN

250MG/5ML

N011870 001

250MG

A084388 001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

CHLOROTHIAZIDE

TABLET; ORAL
CHLOROTHIAZIDE MYLAN AB WEST WARD AB AB

3 - 93 (of 424)

500MG 250MG 500MG

A084217 001 A086028 001 A087736 001

Jul 14, 1982

Jul 14, 1982

CHLOROTHIAZIDE SODIUM
INJECTABLE; INJECTION CHLOROTHIAZIDE SODIUM APP PHARMS AP SUN PHARMA GLOBAL AP DIURIL AP + LUNDBECK INC

EQ 500MG BASE/VIAL EQ 500MG BASE/VIAL EQ 500MG BASE/VIAL

A090896 001 A091546 001 N011145 005

Oct 16, 2009 Jul 26, 2011

CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE

SOLUTION; ORAL
ZUTRIPRO
XX + CYPRESS PHARM

4MG/5ML;5MG/5ML;60MG/5ML

N022439 001

Jun 08, 2011

CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX

CAPSULE, EXTENDED RELEASE; ORAL TUSSICAPS HI-TECH PHARMA CO EQ 4MG MALEATE;EQ 5MG BITARTRATE XX EQ 8MG MALEATE;EQ 10MG BITARTRATE XX + SUSPENSION, EXTENDED RELEASE; ORAL HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX TRIS PHARMA INC AB EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML TUSSIONEX PENNKINETIC AB + UCB INC EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML

A077273 002 A077273 001

Sep 24, 2007 Sep 24, 2007

A091632 001

Oct 01, 2010

N019111 001

Dec 31, 1987

CHLORPROMAZINE HYDROCHLORIDE
INJECTABLE; INJECTION

CHLORPROMAZINE HYDROCHLORIDE

25MG/ML XX + BAXTER HLTHCARE TABLET; ORAL CHLORPROMAZINE HYDROCHLORIDE BP SANDOZ 10MG BP 25MG BP 50MG BP + 100MG BP 200MG BP USL PHARMA 10MG BP 25MG BP 50MG BP 100MG BP 200MG

A083329 001

A080439 A080439 A080439 A080439 A080439 A083386 A084112 A084113 A084114 A084115

001 002 003 004 005 001 001 001 001 001

CHLORPROPAMIDE
TABLET; ORAL CHLORPROPAMIDE MYLAN AB AB PLIVA AB AB WATSON LABS AB AB

100MG 250MG 100MG 250MG 100MG 250MG

A088549 A088549 A088921 A088922 A088852 A088826

002 001 001 001 001 001

Jun Jun Apr Apr Sep Sep

01, 01, 12, 12, 26, 26,

1984 1984 1985 1985 1984 1984

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

CHLORPROPAMIDE
TABLET; ORAL DIABINESE PFIZER AB AB +

3 - 94 (of 424)

100MG 250MG

N011641 003 N011641 006

CHLORTHALIDONE
TABLET; ORAL CHLORTHALIDONE MYLAN AB AB + PLIVA AB AB THALITONE XX + MONARCH PHARMS

25MG 50MG 25MG 50MG 15MG

A086831 A086831 A088902 A088903

002 001 001 001

Sep 19, 1985 Sep 19, 1985 Dec 20, 1988

N019574 001

CHLORTHALIDONE; CLONIDINE HYDROCHLORIDE

TABLET; ORAL CLORPRES MYLAN XX XX XX +

15MG;0.1MG 15MG;0.2MG 15MG;0.3MG

A071325 003 A071325 002 A071325 001

Feb 09, 1987 Feb 09, 1987 Feb 09, 1987

CHLORZOXAZONE
TABLET; ORAL CHLORZOXAZONE BARR AA WATSON LABS AA AA AA PARAFON FORTE DSC AA + JANSSEN R AND D CHLORZOXAZONE MIKART XX XX

500MG 500MG 500MG 500MG 500MG 375MG 750MG

A089895 A040137 A081040 A089859

001 001 001 001

May Aug Aug May

04, 09, 22, 04,

1988 1996 1989 1988

N011529 002 A040861 001 A040861 002

Jun 15, 1987 Jun 01, 2010 Jun 01, 2010

CHOLESTYRAMINE
POWDER; ORAL CHOLESTYRAMINE PAR PHARM AB AB AB + SANDOZ AB CHOLESTYRAMINE LIGHT PAR PHARM AB AB SANDOZ AB AB + LOCHOLEST SANDOZ AB AB LOCHOLEST LIGHT SANDOZ AB AB PREVALITE UPSHER SMITH AB AB

EQ EQ EQ EQ EQ EQ EQ EQ

4GM 4GM 4GM 4GM 4GM 4GM 4GM 4GM

RESIN/SCOOPFUL RESIN/PACKET RESIN/PACKET RESIN/SCOOPFUL RESIN/PACKET RESIN/SCOOPFUL RESIN/SCOOPFUL RESIN/PACKET

A077204 A077204 A074557 A074557 A077203 A077203 A074558 A074558

002 001 001 002 001 002 002 001

Aug Aug Aug Aug Aug Aug Aug Aug

26, 26, 15, 15, 26, 26, 15, 15,

2005 2005 1996 1996 2005 2005 1996 1996

EQ 4GM RESIN/SCOOPFUL EQ 4GM RESIN/PACKET EQ 4GM RESIN/PACKET EQ 4GM RESIN/SCOOPFUL EQ 4GM RESIN/PACKET EQ 4GM RESIN/SCOOPFUL

A074561 002 A074561 001 A074562 001 A074562 002 A073263 001 A073263 002

Aug 15, 1996 Aug 15, 1996 Aug 15, 1996 Aug 15, 1996 Feb 22, 1996 Oct 30, 1997

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

CHOLINE FENOFIBRATE
CAPSULE, DELAYED RELEASE; ORAL TRILIPIX ABBOTT LABS EQ 45MG FENOFIBRIC ACID XX EQ 135MG FENOFIBRIC ACID XX +

3 - 95 (of 424)

N022224 001 N022224 002

Dec 15, 2008 Dec 15, 2008

CHORIOGONADOTROPIN ALFA
INJECTABLE; SUBCUTANEOUS

OVIDREL

XX + EMD SERONO

EQ 0.25MG /0.5ML

N021149 002

Oct 06, 2003

CHROMIC CHLORIDE
INJECTABLE; INJECTION

CHROMIC CHLORIDE IN PLASTIC CONTAINER

XX + HOSPIRA EQ 0.004MG CHROMIUM/ML

N018961 001

Jun 26, 1986

CICLESONIDE
AEROSOL, METERED; INHALATION ALVESCO NYCOMED US 0.08MG/INH XX 0.16MG/INH XX + SPRAY, METERED; NASAL

OMNARIS

XX + NYCOMED US

N021658 002 N021658 003

Jan 10, 2008 Jan 10, 2008

0.05MG/INH

N022004 001

Oct 20, 2006

CICLOPIROX
CREAM; TOPICAL CICLOPIROX ALTANA G AND W LABS INC GLENMARK PHARMS PERRIGO TARO LOPROX + MEDICIS

AB AB AB AB AB AB

0.77% 0.77% 0.77% 0.77% 0.77% 0.77%

A076435 A078463 A090273 A077364 A076790

001 001 001 001 001

Dec Dec Nov Mar Apr

29, 20, 10, 03, 12,

2004 2010 2009 2006 2005

N018748 001

Dec 30, 1982

GEL; TOPICAL CICLOPIROX NYCOMED US AB PADDOCK LLC AB LOPROX AB + MEDICIS SHAMPOO; TOPICAL CICLOPIROX NYCOMED US PADDOCK LLC PERRIGO TARO LOPROX + MEDICIS SOLUTION; TOPICAL CICLOPIROX ACTAVIS MID ATLANTIC APOTEX CORP G AND W LABS HI TECH PHARMA PERRIGO NEW YORK SYNERX PHARMA TARO PHARM INDS TEVA PHARMS

0.77% 0.77% 0.77%

A077896 001 A078266 001 N020519 001

Jun 10, 2008 Jan 07, 2009 Jul 21, 1997

AT AT AT AT AT

1% 1% 1% 1% 1%

A090146 A090490 A078594 A090269

001 001 001 001

May Nov Feb Feb

25, 24, 16, 23,

2010 2009 2010 2011

N021159 001

Feb 28, 2003

AT AT AT AT AT AT AT AT

8% 8% 8% 8% 8% 8% 8% 8%

A078046 A078172 A078233 A078270 A077623 A078567 A078144 A078079

001 001 001 001 001 001 001 001

Sep Sep Sep Sep Sep Sep Sep Sep

18, 18, 18, 18, 18, 18, 18, 18,

2007 2007 2007 2007 2007 2007 2007 2007

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

CICLOPIROX
SOLUTION; TOPICAL CICLOPIROX TOLMAR VERSAPHARM WATSON LABS PENLAC + SANOFI AVENTIS US SUSPENSION; TOPICAL CICLOPIROX ALTANA PERRIGO NEW YORK TARO LOPROX + MEDICIS

3 - 96 (of 424)

AT AT AT AT

8% 8% 8% 8%

A077687 001 A078975 001 A078124 001 N021022 001

Sep 18, 2007 Feb 17, 2010 Sep 18, 2007 Dec 17, 1999

AB AB AB AB

0.77% 0.77% 0.77% 0.77%

A076422 001 A077676 001 A077092 001 N019824 001

Aug 06, 2004 Dec 15, 2006 Aug 10, 2005 Dec 30, 1988

CIDOFOVIR
INJECTABLE; INJECTION

VISTIDE

XX + GILEAD

EQ 75MG BASE/ML

N020638 001

Jun 26, 1996

CILASTATIN SODIUM; IMIPENEM

INJECTABLE; INJECTION IMIPENEM AND CILASTATIN ACS DOBFAR AP EQ AP EQ HOSPIRA INC AP EQ AP EQ AP EQ PRIMAXIN MERCK AP EQ AP + EQ AP EQ AP + EQ AP EQ

250MG 500MG 250MG 500MG 500MG 250MG 250MG 500MG 500MG 500MG

BASE/VIAL;250MG/VIAL BASE/VIAL;500MG/VIAL BASE/VIAL;250MG/VIAL BASE/VIAL;500MG/VIAL BASE/VIAL;500MG/VIAL BASE/VIAL;250MG/VIAL BASE/VIAL;250MG/VIAL BASE/VIAL;500MG/VIAL BASE/VIAL;500MG/VIAL BASE/VIAL;500MG/VIAL

A090577 A090577 A090825 A090825 A091007 A062756 N050587 A062756 N050587 N050630

001 002 001 002 001 001 001 002 002 001

Dec Dec Nov Nov Nov Jan Nov Jan Nov Dec

21, 21, 16, 16, 16, 08, 26, 08, 26, 14,

2011 2011 2011 2011 2011 1987 1985 1987 1985 1990

CILOSTAZOL
TABLET; ORAL CILOSTAZOL ALPHAPHARM AB AB APOTEX INC AB AB BRECKENRIDGE PHARM AB AB COREPHARMA AB AB MYLAN AB AB PLIVA HRVATSKA DOO AB AB ROXANE AB AB SANDOZ AB AB TEVA AB AB PLETAL AB + OTSUKA AB +

50MG 100MG 50MG 100MG 50MG 100MG 50MG 100MG 50MG 100MG 50MG 100MG 50MG 100MG 50MG 100MG 50MG 100MG 50MG 100MG

A077019 A077019 A077030 A077030 A077708 A077708 A077150 A077022 A077323 A077323 A077898 A077898 A077024 A077024 A077310 A077021 A077027 A077027

001 002 001 002 001 002 001 001 002 001 001 002 001 002 001 001 001 002

Nov Nov Dec Dec Sep Sep Mar Nov Apr Apr Oct Oct May May Nov Nov Nov Nov

23, 23, 10, 10, 28, 28, 11, 23, 20, 20, 29, 29, 17, 17, 08, 23, 24, 24,

2004 2004 2004 2004 2009 2009 2005 2004 2006 2006 2007 2007 2005 2005 2005 2004 2004 2004

N020863 001 N020863 002

Jan 15, 1999 Jan 15, 1999

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

CIMETIDINE
TABLET; ORAL CIMETIDINE APOTEX AB AB AB AB DAVA PHARMS INC AB AB AB IVAX SUB TEVA PHARMS AB AB AB AB MYLAN AB AB AB AB PLIVA AB AB AB AB SANDOZ AB AB AB AB TEVA AB AB AB AB WATSON LABS AB AB AB AB TAGAMET GLAXOSMITHKLINE AB AB AB AB +

3 - 97 (of 424)

200MG 300MG 400MG 800MG 300MG 400MG 800MG 200MG 300MG 400MG 800MG 200MG 300MG 400MG 800MG 200MG 300MG 400MG 800MG 200MG 300MG 400MG 800MG 200MG 300MG 400MG 800MG 200MG 300MG 400MG 800MG 200MG 300MG 400MG 800MG

A074890 A074890 A074890 A074890 A074340 A074340 A074339 A074424 A074424 A074424 A074424 A074246 A074246 A074246 A074246 A074568 A074568 A074568 A074566 A074506 A074506 A074506 A074506 A074151 A074151 A074151 A074463 A074349 A074349 A074349 A074316 N017920 N017920 N017920 N017920

001 002 003 004 001 002 001 001 002 003 004 001 002 003 004 001 002 003 001 001 002 003 004 001 002 003 001 001 002 003 001 002 003 004 005

Dec Dec Dec Dec Jun Jun Jun Jul Jul Jul Jul May May May May Feb Feb Feb Feb Jan Jan Jan Jan May May May May Aug Aug Aug Feb

18, 18, 18, 18, 23, 23, 23, 28, 28, 28, 28, 17, 17, 17, 17, 27, 27, 27, 27, 24, 24, 24, 24, 17, 17, 17, 17, 30, 30, 30, 28,

1998 1998 1998 1998 1995 1995 1995 1995 1995 1995 1995 1994 1994 1994 1994 1997 1997 1997 1997 1996 1996 1996 1996 1994 1994 1994 1994 1996 1996 1996 1996

Dec 14, 1983 Apr 30, 1986

CIMETIDINE HYDROCHLORIDE
INJECTABLE; INJECTION CIMETIDINE HYDROCHLORIDE DAVA PHARMS INC AP EQ 300MG BASE/2ML HOSPIRA AP EQ 300MG BASE/2ML AP EQ 300MG BASE/2ML SOLUTION; ORAL CIMETIDINE HYDROCHLORIDE + HI TECH PHARMA EQ NOVEX EQ PHARM ASSOC EQ TEVA EQ WOCKHARDT EQ

A074428 001 A074344 001 A074345 001

Apr 25, 1996 Jan 31, 1995 Jan 31, 1995

AA AA AA AA AA

300MG 300MG 300MG 300MG 300MG

BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML

A074664 A075560 A074553 A074610 A074757

001 001 001 001 001

Oct Mar Jan Sep Oct

28, 15, 27, 26, 17,

1997 2000 1997 1996 1997

CINACALCET HYDROCHLORIDE
TABLET; ORAL SENSIPAR AMGEN XX XX XX +

EQ 30MG BASE EQ 60MG BASE EQ 90MG BASE

N021688 001 N021688 002 N021688 003

Mar 08, 2004 Mar 08, 2004 Mar 08, 2004

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

CIPROFLOXACIN
FOR SUSPENSION; ORAL CIPRO BAYER HLTHCARE XX XX + INJECTABLE; INJECTION CIPRO + BAYER HLTHCARE + CIPRO IN DEXTROSE 5% IN + BAYER HLTHCARE + CIPROFLOXACIN CLARIS LIFESCIENCES

3 - 98 (of 424)

250MG/5ML 500MG/5ML

N020780 001 N020780 002

Sep 26, 1997 Sep 26, 1997

AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP

400MG/40ML (10MG/ML) 200MG/20ML (10MG/ML) PLASTIC CONTAINER 200MG/100ML 400MG/200ML

N019847 001 N019847 002 N019857 001 N019857 002 A078062 A078062 A076717 A076717 A077245 A077245 A077782 A077782 A078252 A078252 A077888 A077888 A078024 A078024 A078431 A077753 A077753 001 002 001 002 002 001 002 001 001 002 001 002 001 002 001 001 002

Dec 26, 1990 Dec 26, 1990 Dec 26, 1990 Dec 26, 1990 Apr Apr Dec Dec Aug Aug Aug Aug Mar Mar Mar Mar Mar Mar Nov Mar Mar 29, 29, 22, 22, 28, 28, 28, 28, 18, 18, 18, 18, 18, 18, 18, 18, 18, 2008 2008 2009 2009 2006 2006 2006 2006 2008 2008 2008 2008 2008 2008 2009 2008 2008

200MG/20ML (10MG/ML) 400MG/40ML (10MG/ML) HIKMA FARMACEUTICA 200MG/20ML (10MG/ML) 400MG/40ML (10MG/ML) HOSPIRA 400MG/40ML (10MG/ML) 200MG/20ML (10MG/ML) TEVA PARENTERAL 400MG/40ML (10MG/ML) 200MG/20ML (10MG/ML) CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ACS DOBFAR INFO SA 200MG/100ML 400MG/200ML BAXTER HLTHCARE 200MG/100ML 400MG/200ML CLARIS LIFESCIENCES 200MG/100ML 400MG/200ML HIKMA FARMACEUTICA 400MG/200ML HOSPIRA 200MG/100ML 400MG/200ML

CIPROFLOXACIN HYDROCHLORIDE
OINTMENT; OPHTHALMIC

CILOXAN

XX + ALCON PHARMS LTD

EQ 0.3% BASE

N020369 001

Mar 30, 1998

AT AT AT AT AT AT AT AT

SOLUTION/DROPS; OPHTHALMIC CILOXAN + ALCON PHARMS LTD EQ 0.3% CIPROFLOXACIN HYDROCHLORIDE AKORN INC EQ 0.3% APOTEX EQ 0.3% BAUSCH AND LOMB EQ 0.3% FDC LTD EQ 0.3% HITECH PHARMA EQ 0.3% NEXUS PHARMS EQ 0.3% PHARMAFORCE EQ 0.3%

BASE BASE BASE BASE BASE BASE BASE BASE

N019992 001 A076555 A075928 A076754 A077568 A076673 A077689 A078598 001 001 001 001 001 001 001

Dec 31, 1990 Dec Jun Jun Jun Jan Dec Jan 11, 09, 09, 30, 21, 13, 16, 2008 2004 2004 2008 2005 2006 2008

SOLUTION/DROPS; OTIC
CETRAXAL
XX + WRASER PHARMS

EQ 0.2% BASE

N021918 001

May 01, 2009

TABLET; ORAL CIPRO BAYER HLTHCARE AB EQ 100MG AB EQ 250MG AB + EQ 500MG AB EQ 750MG CIPROFLOXACIN HYDROCHLORIDE APOTEX AB EQ 250MG AB EQ 500MG

BASE BASE BASE BASE BASE BASE

N019537 N019537 N019537 N019537

001 002 003 004

Apr Oct Oct Oct

08, 22, 22, 22,

1996 1987 1987 1987

A076896 001 A076896 002

Nov 04, 2004

Nov 04, 2004

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

CIPROFLOXACIN HYDROCHLORIDE
TABLET; ORAL CIPROFLOXACIN HYDROCHLORIDE APOTEX EQ 750MG AUROBINDO PHARMA EQ 250MG EQ 500MG EQ 750MG CARLSBAD EQ 250MG EQ 500MG EQ 750MG DR REDDYS LABS LTD EQ 100MG EQ 250MG EQ 500MG EQ 750MG HIKMA EQ 250MG EQ 500MG EQ 750MG IVAX SUB TEVA PHARMS EQ 250MG EQ 500MG EQ 750MG MYLAN EQ 100MG EQ 250MG EQ 250MG EQ 500MG EQ 500MG EQ 750MG EQ 750MG RANBAXY EQ 250MG EQ 500MG EQ 750MG TARO EQ 100MG EQ 250MG EQ 500MG EQ 750MG UNIQUE PHARM LABS EQ 250MG EQ 500MG EQ 750MG WATSON LABS EQ 100MG EQ 250MG EQ 500MG EQ 750MG CIPROFLOXACIN HYDROCHLORIDE PLIVA EQ 100MG EQ 250MG EQ 500MG EQ 750MG

3 - 99 (of 424)

AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB BX BX BX BX

BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE

A076896 A077859 A077859 A077859 A076126 A076126 A076126 A075593 A075593 A075593 A075593 A076558 A076558 A076558 A076089 A076089 A076089 A075817 A075685 A075817 A075685 A075817 A075685 A075817 A075747 A075747 A075747 A076912 A076912 A076912 A076912 A076639 A076639 A076639 A076794 A076794 A076794 A076794 A076426 A076426 A076426 A076426

003 001 002 003 002 003 004 002 003 004 001 002 003 004 002 003 004 001 002 002 003 003 001 004 001 002 003 001 002 003 004 001 002 003 001 002 003 004 001 002 003 004

Nov Apr Apr Apr Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Feb Oct Oct Oct Sep Sep Sep Feb Jun Jun Jun Jun Jun Jun Jun

04, 26, 26, 26, 09, 09, 09, 09, 09, 09, 09, 09, 09, 09, 09, 09, 09, 25, 09, 09, 09, 09, 09, 09, 09, 09, 09, 18, 06, 06, 06, 10, 10, 10, 10, 09, 09, 09, 15, 15, 15, 15,

2004 2007 2007 2007 2004 2004 2004 2004 2004 2004 2004 2004 2004 2004 2004 2004 2004 2007 2004 2004 2004 2004 2004 2004 2004 2004 2004 2005 2004 2004 2004 2004 2004 2004 2005 2004 2004 2004 2005 2005 2005 2005

CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE

SUSPENSION/DROPS; OTIC
CIPRO HC
XX + ALCON PHARMS LTD

EQ 0.2% BASE;1%

N020805 001

Feb 10, 1998

CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE

TABLET, EXTENDED RELEASE; ORAL CIPRO XR + BAYER HLTHCARE 212.6MG;EQ + 425.2MG;EQ CIPROFLOXACIN EXTENDED RELEASE ANCHEN PHARMS 212.6MG;EQ 425.2MG;EQ

AB AB AB AB

287.5MG BASE 574.9MG BASE 287.5MG BASE 574.9MG BASE

N021473 001 N021473 002 A078166 002 A078166 001

Dec 13, 2002 Aug 28, 2003 Nov 27, 2007 Nov 27, 2007

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE
TABLET, EXTENDED RELEASE; ORAL CIPROFLOXACIN EXTENDED RELEASE DR REDDYS LABS LTD 212.6MG;EQ 425.2MG;EQ MYLAN 212.6MG;EQ 425.2MG;EQ WATSON LABS FLORIDA 212.6MG;EQ 425.2MG;EQ

3 - 100 (of 424)

AB AB AB AB AB AB

287.5MG 574.9MG 287.5MG 574.9MG 287.5MG 574.9MG

BASE BASE BASE BASE BASE BASE

A077902 A077701 A078183 A078183 A077417 A077809

001 001 001 002 001 001

Oct Mar Mar Mar Nov Nov

31, 26, 22, 22, 30, 30,

2007 2007 2007 2007 2010 2010

CIPROFLOXACIN; DEXAMETHASONE
SUSPENSION/DROPS; OTIC
CIPRODEX
XX + ALCON PHARMS LTD

0.3%;0.1%

N021537 001

Jul 18, 2003

CISATRACURIUM BESYLATE

INJECTABLE; INJECTION

NIMBEX
EQ 2MG BASE/ML XX + ABBOTT NIMBEX PRESERVATIVE FREE EQ 2MG BASE/ML XX + ABBOTT EQ 10MG BASE/ML XX +

N020551 001 N020551 003 N020551 002

Dec 15, 1995 Dec 15, 1995 Dec 15, 1995

CISPLATIN
INJECTABLE; INJECTION CISPLATIN + APP PHARMS BEDFORD PHARMACHEMIE TEVA PARENTERAL

AP AP AP AP

1MG/ML 1MG/ML 1MG/ML 1MG/ML

A074735 A075036 A074656 A074814

001 001 001 001

Jul Nov May May

16, 07, 16, 16,

1999 2000 2000 2000

CITALOPRAM HYDROBROMIDE
CAPSULE; ORAL CITALOPRAM HYDROBROMIDE ALPHAPHARM EQ 10MG BASE XX EQ 20MG BASE XX EQ 40MG BASE XX + SOLUTION; ORAL CELEXA + FOREST LABS CITALOPRAM HYDROBROMIDE AUROBINDO PHARMA LTD ROXANE SILARX

A077668 001 A077668 002 A077668 003

Feb 28, 2007 Feb 28, 2007 Feb 28, 2007

AA AA AA AA

EQ 10MG BASE/5ML EQ 10MG BASE/5ML EQ 10MG BASE/5ML EQ 10MG BASE/5ML

N021046 001 A077812 001 A077043 001 A077629 001

Dec 22, 1999 Aug 28, 2006 Dec 13, 2004 Jun 15, 2006

TABLET; ORAL CELEXA FOREST LABS AB AB AB + CITALOPRAM HYDROBROMIDE ALPHAPHARM AB AB AB AMNEAL PHARMS NY AB AB AB APOTEX INC AB AB AB

EQ 10MG BASE EQ 20MG BASE EQ 40MG BASE EQ EQ EQ EQ EQ EQ EQ EQ EQ 10MG 20MG 40MG 10MG 20MG 40MG 10MG 20MG 40MG BASE BASE BASE BASE BASE BASE BASE BASE BASE

N020822 001 N020822 002 N020822 003 A077037 A077037 A077037 A077289 A077289 A077289 A077046 A077046 A077046 001 002 003 001 002 003 001 002 003

Apr 27, 2000 Jul 17, 1998 Jul 17, 1998 Nov Nov Nov Nov Nov Nov Nov Nov Nov 05, 05, 05, 30, 30, 30, 24, 24, 24, 2004 2004 2004 2006 2006 2006 2004 2004 2004

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

CITALOPRAM HYDROBROMIDE
TABLET; ORAL CITALOPRAM HYDROBROMIDE AUROBINDO EQ AB EQ AB AB EQ CARACO EQ AB EQ AB EQ AB COREPHARMA EQ AB EQ AB EQ AB DR REDDYS LABS LTD AB EQ EQ AB AB EQ EPIC PHARMA EQ AB EQ AB EQ AB GLENMARK GENERICS EQ AB EQ AB EQ AB INVAGEN PHARMS EQ AB EQ AB EQ AB IVAX SUB TEVA PHARMS EQ AB EQ AB EQ AB MYLAN EQ AB EQ AB EQ AB EQ AB EQ AB EQ AB NATCO PHARMA LTD EQ AB EQ AB PLIVA EQ AB AB EQ AB EQ SANDOZ AB EQ AB EQ AB EQ TORRENT PHARMS AB EQ AB EQ AB EQ WATSON LABS AB EQ AB EQ AB EQ AB EQ AB EQ AB EQ

3 - 101 (of 424)

10MG 20MG 40MG 10MG 20MG 40MG 10MG 20MG 40MG 10MG 20MG 40MG 10MG 20MG 40MG 10MG 20MG 40MG 10MG 20MG 40MG 10MG 20MG 40MG 10MG 10MG 20MG 20MG 40MG 40MG 20MG 40MG 10MG 20MG 40MG 10MG 20MG 40MG 10MG 20MG 40MG 10MG 10MG 20MG 20MG 40MG 40MG

BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE

A077031 A077031 A077031 A077032 A077032 A077032 A077036 A077036 A077036 A077038 A077038 A077038 A077045 A077045 A077045 A077654 A077654 A077654 A077534 A077534 A077534 A077048 A077048 A077048 A077039 A077042 A077039 A077042 A077039 A077042 A077141 A077141 A077232 A077232 A077232 A077035 A077035 A077035 A078216 A078216 A078216 A077034 A077044 A077034 A077044 A077034 A077044

001 002 003 001 002 003 001 002 003 001 002 003 003 002 001 001 002 003 001 002 003 001 002 003 001 001 002 002 003 003 002 001 001 002 003 001 002 003 001 002 003 001 001 002 002 003 003

Oct Oct Oct Nov Nov Nov Oct Oct Oct Oct Oct Oct Apr Apr Apr Feb Feb Feb Oct Oct Oct Nov Nov Nov Feb Nov Feb Nov Feb Nov Apr Apr Oct Oct Oct Oct Oct Oct Mar Mar Mar Jun Nov Jun Nov Jun Nov

28, 28, 28, 12, 12, 12, 28, 28, 28, 28, 28, 28, 29, 29, 29, 27, 27, 27, 03, 03, 03, 16, 16, 16, 03, 05, 03, 05, 03, 05, 10, 10, 31, 31, 31, 28, 28, 28, 27, 27, 27, 30, 05, 30, 05, 30, 05,

2004 2004 2004 2004 2004 2004 2004 2004 2004 2004 2004 2004 2005 2005 2005 2009 2009 2009 2006 2006 2006 2004 2004 2004 2005 2004 2005 2004 2005 2004 2008 2008 2005 2005 2005 2004 2004 2004 2007 2007 2007 2005 2004 2005 2004 2005 2004

CITRIC ACID; GLUCONOLACTONE; MAGNESIUM CARBONATE

SOLUTION; IRRIGATION

RENACIDIN

XX + UNITED GUARDIAN

6.602GM/100ML;198MG/100ML;3.177GM/100ML

N019481 001

Oct 02, 1990

CITRIC ACID; UREA C-13

FOR SOLUTION, TABLET, FOR SOLUTION; ORAL

IDKIT:HP

XX + EXALENZ BIOSCIENCE N/A,4GM;75MG,N/A

N021314 001

Dec 17, 2002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

CLADRIBINE
INJECTABLE; INJECTION CLADRIBINE APP PHARMS BEDFORD ONCO THERAPIES LTD LEUSTATIN + JANSSEN PHARMS

3 - 102 (of 424)

AP AP AP AP

1MG/ML 1MG/ML 1MG/ML 1MG/ML

A076571 001 A075405 001 A200510 001 N020229 001

Apr 22, 2004 Feb 28, 2000 Oct 06, 2011 Feb 26, 1993

CLARITHROMYCIN
FOR SUSPENSION; ORAL BIAXIN ABBOTT AB AB + CLARITHROMYCIN RANBAXY AB AB SANDOZ AB AB TABLET; ORAL BIAXIN AB + ABBOTT AB + CLARITHROMYCIN APOTEX CORP AB AB MYLAN AB AB RANBAXY AB AB ROXANE AB AB SANDOZ AB AB TEVA AB AB WOCKHARDT AB AB TABLET, EXTENDED RELEASE; BIAXIN XL + ABBOTT CLARITHROMYCIN SANDOZ TEVA WATSON LABS FLORIDA

125MG/5ML 250MG/5ML 125MG/5ML 250MG/5ML 125MG/5ML 250MG/5ML

N050698 001 N050698 002 A065382 A065382 A065283 A065283 001 002 002 003

Dec 23, 1993 Dec 23, 1993 Aug Aug Sep Sep 30, 30, 04, 04, 2007 2007 2007 2007

250MG 500MG 250MG 500MG 250MG 500MG 250MG 500MG 250MG 500MG 250MG 500MG 250MG 500MG 250MG 500MG ORAL 500MG 500MG 500MG 500MG

N050662 001 N050662 002 A065384 A065384 A065195 A065195 A065174 A065174 A065178 A065178 A065144 A065136 A065155 A065155 A065266 A065266 001 002 001 002 001 002 002 001 001 001 001 002 001 002

Oct 31, 1991 Oct 31, 1991 Aug Aug Mar Mar Sep Sep May May Oct Aug May May May May 20, 20, 11, 11, 24, 24, 25, 25, 18, 25, 31, 31, 31, 31, 2007 2007 2005 2005 2004 2004 2004 2004 2005 2005 2005 2005 2006 2006

AB AB AB AB

N050775 001 A065250 001 A065154 001 A065145 001

Mar 03, 2000 Aug 25, 2005 May 18, 2005 Jun 24, 2004

CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM

INJECTABLE; INJECTION

TIMENTIN
EQ 1GM BASE/VIAL;EQ 30GM BASE/VIAL XX + GLAXOSMITHKLINE EQ 100MG BASE/VIAL;EQ 3GM BASE/VIAL XX EQ 100MG BASE/VIAL;EQ 3GM BASE/VIAL XX + EQ 200MG BASE/VIAL;EQ 3GM BASE/VIAL XX + TIMENTIN IN PLASTIC CONTAINER EQ 100MG BASE/100ML;EQ 3GM BASE/100ML XX + GLAXOSMITHKLINE

N050590 A062691 N050590 N050590

003 001 001 002

Aug Dec Apr Apr

18, 19, 01, 01,

1987 1986 1985 1985

N050658 001

Dec 15, 1989

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

CLEMASTINE FUMARATE
SYRUP; ORAL CLEMASTINE FUMARATE NOVEX SILARX + TEVA WOCKHARDT

3 - 103 (of 424)

AA AA AA AA

EQ EQ EQ EQ

0.5MG 0.5MG 0.5MG 0.5MG

BASE/5ML BASE/5ML BASE/5ML BASE/5ML

A075703 A074884 A073399 A074863

001 001 001 001

Nov Dec Jun Mar

27, 17, 30, 13,

2000 1997 1994 1998

TABLET; ORAL CLEMASTINE FUMARATE SANDOZ AB AB + TEVA

2.68MG 2.68MG

A073459 001 A073283 001

Oct 31, 1993 Jan 31, 1992

CLEVIDIPINE BUTYRATE
EMULSION; INTRAVENOUS

CLEVIPREX

XX + MEDICINES CO XX +

25MG/50ML (0.5MG/ML) 50MG/100ML (0.5MG/ML)

N022156 001 N022156 002

Aug 01, 2008 Aug 01, 2008

CLINDAMYCIN HYDROCHLORIDE
CAPSULE; ORAL CLEOCIN HYDROCHLORIDE PHARMACIA AND UPJOHN EQ AB AB EQ AB + EQ CLINDAMYCIN HYDROCHLORIDE AUROBINDO PHARMA AB EQ AB EQ COREPHARMA AB EQ AB EQ LANNETT AB EQ AB EQ AB EQ MATRIX LABS LTD AB EQ AB EQ AB EQ RANBAXY AB EQ AB EQ TEVA AB EQ AB EQ WATSON LABS AB EQ AB EQ ZYDUS PHARMS USA AB EQ AB EQ AB EQ

75MG BASE 150MG BASE 300MG BASE 150MG BASE 300MG BASE 150MG BASE 300MG BASE 75MG BASE 150MG BASE 300MG BASE 75MG BASE 150MG BASE 300MG BASE 150MG BASE 300MG BASE 150MG BASE 300MG BASE 150MG BASE 300MG BASE 75MG BASE 150MG BASE 300MG BASE

N050162 001 N050162 002 N050162 003 A065442 A065442 A065194 A065194 A065242 A065242 A065243 A091225 A091225 A091225 A065061 A065061 A063029 A063029 A063083 A063083 A065217 A065217 A065217 001 002 001 002 001 002 001 001 002 003 001 002 001 002 001 002 001 002 003

Apr 14, 1988 Aug Aug Mar Mar Aug Aug Aug May May May Feb Feb Sep Aug Jul Mar Jan Jan Jan 26, 26, 22, 22, 12, 12, 12, 31, 31, 31, 02, 02, 20, 05, 31, 18, 31, 31, 31, 2009 2009 2004 2004 2005 2005 2005 2011 2011 2011 2001 2001 1989 2005 1991 2003 2005 2005 2005

CLINDAMYCIN PALMITATE HYDROCHLORIDE

FOR SOLUTION; ORAL CLEOCIN AA + PHARMACIA AND UPJOHN EQ 75MG BASE/5ML CLINDAMYCIN PALMITATE HYDROCHLORIDE PADDOCK LABS AA EQ 75MG BASE/5ML

A062644 001 A090902 001

Apr 07, 1986 Jul 07, 2010

CLINDAMYCIN PHOSPHATE
AEROSOL, FOAM; TOPICAL CLINDAMYCIN PHOSPHATE PERRIGO UK FINCO AT EVOCLIN AT + STIEFEL LABS INC

1% 1%

A090785 001 N050801 001

Mar 31, 2010 Oct 22, 2004

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

CLINDAMYCIN PHOSPHATE
CREAM; VAGINAL CLEOCIN AB + PHARMACIA AND UPJOHN CLINDAMYCIN PHOSPHATE NYCOMED US AB CLINDESSE XX + KV PHARM GEL; TOPICAL CLEOCIN T AB + PHARMACIA AND UPJOHN CLINDAMYCIN PHOSPHATE ALTANA AB CLINDAGEL BT + GALDERMA LABS LP

3 - 104 (of 424)

EQ 2% BASE EQ 2% BASE EQ 2% BASE

N050680 002 A065139 001 N050793 001

Mar 02, 1998 Dec 27, 2004 Nov 30, 2004

EQ 1% BASE EQ 1% BASE EQ 1% BASE

N050615 001 A064160 001 N050782 001

Jan 07, 1987 Jan 28, 2000 Nov 27, 2000

INJECTABLE; INJECTION CLEOCIN PHOSPHATE PHARMACIA AND UPJOHN EQ 150MG BASE/ML AP AP + EQ 150MG BASE/ML CLINDAMYCIN PHOSPHATE APP PHARMS AP EQ 150MG BASE/ML AP EQ 150MG BASE/ML BAXTER HLTHCARE AP EQ 150MG BASE/ML BEDFORD AP EQ 150MG BASE/ML HOSPIRA AP EQ 150MG BASE/ML AP EQ 150MG BASE/ML AP EQ 150MG BASE/ML SAGENT STRIDES AP EQ 150MG BASE/ML AP EQ 150MG BASE/ML CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER XX + PHARMACIA AND UPJOHN EQ 6MG BASE/ML EQ 12MG BASE/ML XX + EQ 18MG BASE/ML XX + CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% EQ 900MG BASE/100ML XX + ABRAXIS PHARM LOTION; TOPICAL CLEOCIN T AB + PHARMACIA AND UPJOHN CLINDAMYCIN PHOSPHATE ALTANA AB SOLUTION; TOPICAL CLEOCIN T + PHARMACIA AND UPJOHN CLINDA-DERM PADDOCK LLC CLINDAMYCIN PHOSPHATE ALTANA FOUGERA PERRIGO NEW YORK TARO PHARM INDS WOCKHARDT

A062803 001 N050441 001 A065346 A065347 A062889 A065206 A062800 A062801 A062943 A090108 A090109 001 001 001 001 001 001 001 001 001

Oct 16, 1987

Mar May Apr Sep Jul Jul Sep Sep Sep

29, 09, 25, 24, 24, 24, 29, 30, 30,

2007 2007 1988 2004 1987 1987 1988 2011 2011

N050639 001 N050639 002 N050639 003 N050635 001

Aug 30, 1989 Aug 30, 1989 Apr 10, 1991 Dec 22, 1989

EQ 1% BASE EQ 1% BASE

N050600 001 A065067 001

May 31, 1989 Jan 31, 2002

AT AT AT AT AT AT AT

EQ 1% BASE EQ 1% BASE EQ EQ EQ EQ EQ 1% 1% 1% 1% 1% BASE BASE BASE BASE BASE

N050537 001 A063329 001 A065254 A064159 A064050 A065184 A063304 001 001 001 001 001 Sep 30, 1992 Feb Jun Nov Mar Jul 14, 05, 30, 31, 15, 2006 1997 1995 2004 1997

SUPPOSITORY; VAGINAL
CLEOCIN
XX + PHARMACIA AND UPJOHN SWAB; TOPICAL CLEOCIN PHARMACIA AND UPJOHN AT CLINDAMYCIN PHOSPHATE PERRIGO NEW YORK AT

100MG

N050767 001

Aug 13, 1999

EQ 1% BASE EQ 1% BASE

N050537 002 A065049 001

Feb 22, 1994 May 25, 2000

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

CLINDAMYCIN PHOSPHATE
SWAB; TOPICAL CLINDAMYCIN PHOSPHATE VERSAPHARM AT CLINDETS PERRIGO AT

3 - 105 (of 424)

EQ 1% BASE EQ 1% BASE

A065513 001 A064136 001

Jun 17, 2010 Sep 30, 1996

CLINDAMYCIN PHOSPHATE; TRETINOIN

GEL; TOPICAL VELTIN BX STIEFEL GSK ZIANA BX + MEDICIS

1.2%;0.025% 1.2%;0.025%

N050803 001 N050802 001

Jul 16, 2010 Nov 07, 2006

CLOBAZAM
TABLET; ORAL ONFI XX LUNDBECK INC XX XX +

5MG 10MG 20MG

N202067 001 N202067 002 N202067 003

Oct 21, 2011 Oct 21, 2011 Oct 21, 2011

CLOBETASOL PROPIONATE
AEROSOL, FOAM; TOPICAL CLOBETASOL PROPIONATE PERRIGO ISRAEL AB OLUX AB + STIEFEL LABS INC OLUX E XX + STIEFEL LABS INC

0.05% 0.05% 0.05%

A077763 001 N021142 001 N022013 001

Mar 10, 2008 May 26, 2000 Jan 12, 2007

CREAM; TOPICAL CLOBETASOL PROPIONATE FOUGERA AB1 0.05% TARO AB1 0.05% TEVA PHARMS AB1 0.05% CORMAX HI TECH PHARMA AB1 0.05% TEMOVATE AB1 + NYCOMED US 0.05% CLOBETASOL PROPIONATE (EMOLLIENT) ALTANA AB2 0.05% TARO AB2 0.05% EMBELINE E HI TECH PHARMA AB2 0.05% TEMOVATE E AB2 + FOUGERA PHARMS 0.05% GEL; TOPICAL CLOBETASOL PROPIONATE ALTANA PERRIGO TARO EMBELINE HI TECH PHARMA TEMOVATE + NYCOMED US

A074392 001 A074249 001 A074087 001 A074220 001 N019322 001 A075430 001 A075633 001 A075325 001 N020340 001

Sep 30, 1996 Jul 08, 1996 Feb 16, 1994 May 16, 1997 Dec 27, 1985 May 26, 1999 May 17, 2000 Dec 24, 1998 Jun 17, 1994

AB AB AB AB AB

0.05% 0.05% 0.05% 0.05% 0.05%

A075368 001 A075027 001 A075279 001 A076141 001 N020337 001

Feb 15, 2000 Oct 31, 1997 May 28, 1999 Apr 12, 2002 Apr 29, 1994

LOTION; TOPICAL CLOBETASOL PROPIONATE ACTAVIS MID ATLANTIC AB CLOBEX AB + GALDERMA LABS LP

0.05% 0.05%

A078223 001 N021535 001

Dec 04, 2008 Jul 24, 2003

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

CLOBETASOL PROPIONATE
OINTMENT; TOPICAL CLOBETASOL PROPIONATE NYCOMED US TARO TEVA PHARMS EMBELINE HI TECH PHARMA TEMOVATE + NYCOMED US

3 - 106 (of 424)

AB AB AB AB AB

0.05% 0.05% 0.05% 0.05% 0.05%

A074407 001 A074248 001 A074089 001 A074221 001 N019323 001

Feb 23, 1996 Jul 12, 1996 Feb 16, 1994 Mar 31, 1995 Dec 27, 1985

SHAMPOO; TOPICAL CLOBETASOL PROPIONATE ACTAVIS MID ATLANTIC AB CLOBEX AB + GALDERMA LABS SOLUTION; TOPICAL CLOBETASOL PROPIONATE NYCOMED US AT TARO AT AT TOLMAR AT WOCKHARDT AT EMBELINE HI TECH PHARMA AT TEMOVATE AT + NYCOMED US SPRAY; TOPICAL CLOBETASOL PROPIONATE PADDOCK LLC AT CLOBEX AT + GALDERMA LABS LP

0.05% 0.05%

A078854 001 N021644 001

Jun 07, 2011 Feb 05, 2004

0.05% 0.05% 0.05% 0.05% 0.05% 0.05% 0.05%

A075391 A075224 A075363 A076977 A075205

001 001 001 001 001

Feb Nov Dec Aug Nov

08, 16, 29, 05, 13,

1999 1998 2000 2005 1998

A074222 001 N019966 001

Dec 06, 1995 Feb 22, 1990

0.05% 0.05%

A090898 001 N021835 001

Jun 16, 2011 Oct 27, 2005

CLOCORTOLONE PIVALATE
CREAM; TOPICAL
CLODERM
XX + PROMIUS PHARMA LLC

0.1%

N017765 001

CLOFARABINE
INJECTABLE; IV (INFUSION)
CLOLAR
20MG/20ML (1MG/ML) XX + GENZYME

N021673 001

Dec 28, 2004

CLOFAZIMINE
CAPSULE; ORAL
LAMPRENE
XX + NOVARTIS

50MG

N019500 002

Dec 15, 1986

CLOMIPHENE CITRATE
TABLET; ORAL CLOMID AB + SANOFI AVENTIS US CLOMIPHENE CITRATE PAR PHARM AB SEROPHENE EMD SERONO AB

50MG 50MG 50MG

N016131 002 A075528 001 N018361 001 Aug 30, 1999 Mar 22, 1982

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

CLOMIPRAMINE HYDROCHLORIDE
CAPSULE; ORAL ANAFRANIL MALLINCKRODT LLC AB 25MG AB + 50MG AB 75MG CLOMIPRAMINE HYDROCHLORIDE MYLAN AB 25MG AB 50MG AB 75MG SANDOZ AB 25MG AB 50MG AB 75MG TARO AB 25MG AB 50MG AB 75MG TEVA AB 25MG AB 50MG AB 75MG

3 - 107 (of 424)

N019906 001 N019906 002 N019906 003 A074947 A074947 A074947 A074364 A074364 A074364 A074694 A074694 A074694 A074958 A074958 A074958 001 002 003 001 002 003 001 002 003 001 002 003

Dec 29, 1989 Dec 29, 1989 Dec 29, 1989 Apr Apr Apr Mar Mar Mar Dec Dec Dec Aug Aug Aug 30, 30, 30, 29, 29, 29, 31, 31, 31, 26, 26, 26, 1998 1998 1998 1996 1996 1996 1996 1996 1996 1997 1997 1997

CLONAZEPAM
TABLET; ORAL CLONAZEPAM ACCORD HLTHCARE INC AB AB AB ACTAVIS ELIZABETH AB AB AB ALPHAPHARM AB AB AB APOTEX AB AB AB CARACO AB AB AB MYLAN AB AB AB SANDOZ AB AB AB TEVA AB AB AB VINTAGE PHARMS AB AB AB WATSON LABS AB AB AB KLONOPIN ROCHE AB AB + AB

0.5MG 1MG 2MG 0.5MG 1MG 2MG 0.5MG 1MG 2MG 0.5MG 1MG 2MG 0.5MG 1MG 2MG 0.5MG 1MG 2MG 0.5MG 1MG 2MG 0.5MG 1MG 2MG 0.5MG 1MG 2MG 0.5MG 1MG 2MG 0.5MG 1MG 2MG

A077147 A077147 A077147 A074869 A074869 A074869 A074940 A074940 A074940 A075468 A075468 A075468 A075423 A075423 A075423 A075150 A075150 A075150 A074979 A074979 A074979 A074569 A074569 A074569 A077856 A077856 A077856 A074964 A074964 A074964

001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003

May May May Oct Oct Oct Oct Oct Oct Oct Oct Oct Apr Apr Apr Oct Oct Oct Aug Aug Aug Sep Sep Sep Jun Jun Jun Dec Dec Dec

02, 02, 02, 31, 31, 31, 30, 30, 30, 06, 06, 06, 27, 27, 27, 05, 05, 05, 29, 29, 29, 10, 10, 10, 28, 28, 28, 30, 30, 30,

2005 2005 2005 1996 1996 1996 1997 1997 1997 2000 2000 2000 2001 2001 2001 1998 1998 1998 1997 1997 1997 1996 1996 1996 2006 2006 2006 1997 1997 1997

N017533 001 N017533 002 N017533 003

TABLET, ORALLY DISINTEGRATING; ORAL CLONAZEPAM BARR AB 0.125MG

A077194 001

Aug 10, 2005

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

CLONAZEPAM
TABLET, ORALLY DISINTEGRATING; ORAL CLONAZEPAM BARR AB 0.25MG AB 0.5MG AB 1MG AB 2MG PAR PHARM AB 0.125MG AB 0.25MG AB 0.5MG AB + 1MG AB 2MG

3 - 108 (of 424)

A077194 A077194 A077194 A077194 A077171 A077171 A077171 A077171 A077171

002 003 004 005 001 002 003 004 005

Aug Aug Aug Aug Aug Aug Aug Aug Aug

10, 10, 10, 10, 03, 03, 03, 03, 03,

2005 2005 2005 2005 2005 2005 2005 2005 2005

CLONIDINE
FILM, EXTENDED RELEASE; TRANSDERMAL CATAPRES-TTS-1 BOEHRINGER INGELHEIM 0.1MG/24HR CATAPRES-TTS-2 BOEHRINGER INGELHEIM 0.2MG/24HR CATAPRES-TTS-3 + BOEHRINGER INGELHEIM 0.3MG/24HR CLONIDINE AVEVA 0.1MG/24HR 0.2MG/24HR 0.3MG/24HR BARR 0.1MG/24HR 0.2MG/24HR 0.3MG/24HR MYLAN TECHNOLOGIES 0.1MG/24HR 0.2MG/24HR 0.3MG/24HR

AB AB AB AB AB AB AB AB AB AB AB AB

N018891 001 N018891 002 N018891 003 A076157 A076157 A076157 A079090 A079090 A079090 A076166 A076166 A076166 001 002 003 001 002 003 001 002 003

Oct 10, 1984 Oct 10, 1984 Oct 10, 1984 Aug Aug Aug Aug Aug Aug Jul Jul Jul 18, 18, 18, 20, 20, 20, 16, 16, 16, 2009 2009 2009 2010 2010 2010 2010 2010 2010

CLONIDINE HYDROCHLORIDE
INJECTABLE; INJECTION CLONIDINE HYDROCHLORIDE APP PHARMS AP 1MG/10ML (0.1MG/ML) AP 5MG/10ML (0.5MG/ML) HIKMA FARMACEUTICA AP 1MG/10ML (0.1MG/ML) AP 5MG/10ML (0.5MG/ML) LUITPOLD AP 1 MG/10 ML (0.1 MG/ML) AP 5 MG/10 ML (0.5 MG/ML) DURACLON BIONICHE PHARMA USA AP 1 MG/10 ML (0.1 MG/ML) AP + 5 MG/10 ML (0.5 MG/ML) TABLET; ORAL CATAPRES BOEHRINGER INGELHEIM AB AB AB + CLONIDINE HYDROCHLORIDE ACTAVIS ELIZABETH AB AB AB ALEMBIC PHARMS LTD AB AB AB DAVA PHARMS INC AB AB AB IMPAX LABS AB

A200673 A200673 A200300 A200300 A091104 A091104

001 002 001 002 001 002

Jul Jul Jan Jan Oct Oct

08, 08, 26, 26, 08, 08,

2011 2011 2011 2011 2009 2009

N020615 001 N020615 002

Oct 02, 1996 Apr 27, 1999

0.1MG 0.2MG 0.3MG 0.1MG 0.2MG 0.3MG 0.1MG 0.2MG 0.3MG 0.1MG 0.2MG 0.3MG 0.1MG

N017407 001 N017407 002 N017407 003 A070974 A070975 A070976 A091368 A091368 A091368 A071783 A071784 A071785 A078099 001 001 001 001 002 003 001 001 001 001 Dec Dec Dec Dec Dec Dec Apr Apr Apr Aug 16, 16, 16, 06, 06, 06, 05, 05, 05, 27, 1986 1986 1986 2011 2011 2011 1988 1988 1988 2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

CLONIDINE HYDROCHLORIDE
TABLET; ORAL CLONIDINE HYDROCHLORIDE IMPAX LABS AB 0.2MG AB 0.3MG MUTUAL PHARM AB 0.1MG AB 0.2MG AB 0.3MG MYLAN AB 0.1MG AB 0.2MG AB 0.3MG UNICHEM AB 0.1MG AB 0.2MG AB 0.3MG VINTAGE AB 0.1MG AB 0.2MG AB 0.3MG WATSON LABS AB 0.3MG
TABLET, EXTENDED RELEASE; ORAL

KAPVAY
0.1MG XX + SHIONOGI INC

3 - 109 (of 424)

A078099 A078099 A070925 A070924 A070923 A070317 A070317 A070317 A078895 A078895 A078895 A077901 A077901 A077901 A070963

002 003 001 001 001 002 003 001 001 002 003 001 002 003 001

Aug Aug Sep Sep Sep Jul Jun Jun Aug Aug Aug Mar Mar Mar Jul

27, 27, 04, 04, 04, 09, 09, 09, 26, 26, 26, 09, 09, 09, 08,

2009 2009 1987 1987 1987 1987 1987 1987 2009 2009 2009 2007 2007 2007 1986

N022331 003

Sep 28, 2010

CLOPIDOGREL BISULFATE
TABLET; ORAL PLAVIX SANOFI AVENTIS US XX XX +

EQ 75MG BASE EQ 300MG BASE

N020839 001 N020839 002

Nov 17, 1997 Sep 20, 2007

CLORAZEPATE DIPOTASSIUM
TABLET; ORAL CLORAZEPATE DIPOTASSIUM MYLAN AB 3.75MG AB 7.5MG AB 15MG RANBAXY AB 3.75MG AB 7.5MG AB 15MG TARO AB 3.75MG AB 7.5MG AB 15MG WATSON LABS AB 3.75MG AB 7.5MG AB 15MG GEN-XENE ALRA AB 3.75MG AB 7.5MG AB 15MG TRANXENE LUNDBECK INC AB 3.75MG AB 7.5MG AB + 15MG

A071858 A071858 A071858 A076911 A076911 A076911 A075731 A075731 A075731 A071852 A071853 A071854

002 003 001 001 002 003 003 002 001 001 001 001

Jul Jul Jul Sep Sep Sep Apr Apr Apr Feb Feb Feb

17, 17, 17, 29, 29, 29, 27, 27, 27, 09, 09, 09,

1987 1987 1987 2004 2004 2004 2000 2000 2000 1988 1988 1988

A071787 001 A071788 001 A071789 001 N017105 006 N017105 007 N017105 008

Apr 26, 1988 Apr 26, 1988 Apr 26, 1988

CLOTRIMAZOLE
CREAM; TOPICAL CLOTRIMAZOLE GLENMARK PHARMS AB NYCOMED US AB AB + TARO

1% 1% 1%

A090219 001 A078338 001 A072640 001

Aug 03, 2010 Sep 02, 2008 Aug 31, 1993

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

CLOTRIMAZOLE
SOLUTION; TOPICAL CLOTRIMAZOLE TARO AT TEVA AT MYCELEX AT + BAYER HLTHCARE TROCHE/LOZENGE; ORAL CLOTRIMAZOLE PADDOCK LLC AB ROXANE AB MYCELEX AB + BAYER HLTHCARE

3 - 110 (of 424)

1% 1% 1%

A074580 001 A073306 001 N018181 001

Jul 29, 1996 Feb 28, 1995

10MG 10MG 10MG

A076763 001 A076387 001 N018713 001

Oct 28, 2005 Jul 29, 2004 Jun 17, 1983

CLOZAPINE
TABLET; ORAL CLOZAPINE CARACO AB AB AB IVAX SUB TEVA PHARMS AB AB AB AB AB MYLAN AB AB CLOZARIL NOVARTIS AB AB + CLOZAPINE IVAX SUB TEVA PHARMS XX XX

25MG 50MG 100MG 25MG 50MG 50MG 100MG 100MG 25MG 100MG 25MG 100MG 12.5MG 200MG

A075713 A075713 A075713 A074949 A074949 A076809 A074949 A076809 A075417 A075417

001 003 002 001 004 003 002 002 001 002

Nov Aug Nov Nov Apr Dec Nov Dec May May

15, 19, 15, 26, 25, 16, 26, 16, 27, 27,

2002 2005 2002 1997 2005 2005 1997 2005 1999 1999

N019758 001 N019758 002 A074949 003 A076809 001

Sep 26, 1989 Sep 26, 1989 Jul 31, 2003 Dec 16, 2005

XX XX XX XX XX

TABLET, ORALLY DISINTEGRATING; ORAL FAZACLO ODT AZUR PHARMA INTL 12.5MG 25MG + 100MG 150MG 200MG

N021590 N021590 N021590 N021590 N021590

004 001 002 005 006

May Feb Feb Jul Jul

30, 10, 10, 09, 09,

2007 2004 2004 2010 2010

CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE

SYRUP; ORAL PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE VINTAGE AA 10MG/5ML;5MG/5ML;6.25MG/5ML A040660 001 PROMETH VC W/ CODEINE AA + ACTAVIS MID ATLANTIC 10MG/5ML;5MG/5ML;6.25MG/5ML A088764 001

Dec 07, 2006 Oct 31, 1984

CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE

SYRUP; ORAL PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE + ACTAVIS MID ATLANTIC 10MG/5ML;6.25MG/5ML HI TECH PHARMA 10MG/5ML;6.25MG/5ML PHARM ASSOC 10MG/5ML;6.25MG/5ML SUN PHARM INDS INC 10MG/5ML;6.25MG/5ML WOCKHARDT 10MG/5ML;6.25MG/5ML PROMETHAZINE WITH CODEINE VINTAGE 10MG/5ML;6.25MG/5ML

AA AA AA AA AA AA

A088763 A040151 A089647 A090180 A088875

001 001 001 001 001

Oct Aug Dec Mar Dec

31, 26, 22, 17, 17,

1984 1997 1988 2010 1984

A040650 001

Jan 31, 2006

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 111 (of 424)

CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE

SYRUP; ORAL

TRIACIN-C

XX + STI PHARMA LLC

10MG/5ML;30MG/5ML;1.25MG/5ML

A088704 001

Mar 22, 1985

CODEINE SULFATE
SOLUTION; ORAL
CODEINE SULFATE
XX + ROXANE TABLET; ORAL CODEINE SULFATE ROXANE XX XX XX +

30MG/5ML

N202245 001

Jun 30, 2011

15MG 30MG 60MG

N022402 001 N022402 002 N022402 003

Jul 16, 2009 Jul 16, 2009 Jul 16, 2009

COLCHICINE
TABLET; ORAL

COLCRYS

XX + AR HOLDING CO INC

0.6MG

N022352 001

Jul 29, 2009

COLCHICINE; PROBENECID
TABLET; ORAL COL-PROBENECID AB + WATSON LABS 0.5MG;500MG PROBENECID AND COLCHICINE MIRROR PHARMS 0.5MG;500MG AB

A084279 001 A040618 001 May 13, 2008

COLESEVELAM HYDROCHLORIDE
FOR SUSPENSION; ORAL
WELCHOL
DAIICHI SANKYO
XX XX +

TABLET; ORAL

WELCHOL
XX + DAIICHI SANKYO

1.875GM/PACKET 3.75GM/PACKET

N022362 001 N022362 002

Oct 02, 2009 Oct 02, 2009

625MG

N021176 001

May 26, 2000

COLESTIPOL HYDROCHLORIDE
GRANULE; ORAL COLESTID PHARMACIA AND UPJOHN 5GM/SCOOPFUL 5GM/PACKET + COLESTIPOL HYDROCHLORIDE IMPAX LABS 5GM/PACKET 5GM/SCOOPFUL FLAVORED COLESTID
PHARMACIA AND UPJOHN 5GM/PACKET 5GM/SCOOPFUL

AB AB AB AB XX XX

N017563 003 N017563 004 A077277 002 A077277 001 N017563 001
N017563 002

Sep 22, 1995 Sep 22, 1995 May 02, 2006 May 02, 2006

TABLET; ORAL COLESTID AB + PHARMACIA AND UPJOHN 1GM COLESTIPOL HYDROCHLORIDE IMPAX LABS 1GM AB

N020222 001 A077510 001

Jul 19, 1994 Oct 24, 2006

COLISTIMETHATE SODIUM
INJECTABLE; INJECTION COLISTIMETHATE SODIUM APP PHARMS AP PADDOCK LLC AP X GEN PHARMS AP

EQ 150MG BASE/VIAL EQ 150MG BASE/VIAL EQ 150MG BASE/VIAL

A065364 001 A065177 001 A064216 001

Apr 17, 2008 Mar 19, 2004 Feb 26, 1999

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

COLISTIMETHATE SODIUM
INJECTABLE; INJECTION COLY-MYCIN M AP + JHP PHARMS

3 - 112 (of 424)

EQ 150MG BASE/VIAL

N050108 002

COLISTIN SULFATE; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; THONZONIUM BROMIDE

SUSPENSION/DROPS; OTIC
COLY-MYCIN S
XX + JHP PHARMS

EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML

N050356 001

CONIVAPTAN HYDROCHLORIDE
INJECTABLE; IV (INFUSION) VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER XX + ASTELLAS 20MG/100ML (0.2MG/ML)

N021697 002

Oct 08, 2008

COPPER
INTRAUTERINE DEVICE; INTRAUTERINE
PARAGARD T 380A
309MG/COPPER XX + DURAMED RES

N018680 001

Nov 15, 1984

CORTICORELIN OVINE TRIFLUTATE

INJECTABLE; INJECTION
ACTHREL
XX + FERRING

EQ 0.1MG BASE/VIAL

N020162 001

May 23, 1996

CORTICOTROPIN
INJECTABLE; INJECTION H.P. ACTHAR GEL XX + QUESTCOR PHARMS

80 UNITS/ML

N008372 008

CORTISONE ACETATE
TABLET; ORAL
CORTISONE ACETATE
XX + WEST WARD

25MG

A080776 002

COSYNTROPIN
INJECTABLE; INJECTION CORTROSYN AP + AMPHASTAR PHARMS INC COSYNTROPIN BIONICHE PHARMA AP SOLUTION; INTRAVENOUS COSYNTROPIN SANDOZ XX

0.25MG/VIAL 0.25MG/VIAL

N016750 001 A090574 001 Dec 17, 2009

0.25MG/ML (0.25MG/ML)

N022028 001

Feb 21, 2008

CRIZOTINIB
CAPSULE; ORAL XALKORI PFIZER XX XX +

200MG 250MG

N202570 001 N202570 002

Aug 26, 2011 Aug 26, 2011

CROMOLYN SODIUM
AEROSOL, METERED; INHALATION INTAL XX + KING PHARMS 0.8MG/INH

N018887 001

Dec 05, 1985

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

CROMOLYN SODIUM
CONCENTRATE; ORAL CROMOLYN SODIUM PACK PHARMS LLC AA GASTROCROM AA + AZUR PHARMA SOLUTION; INHALATION CROMOLYN SODIUM BAUSCH AND LOMB DEY NOVEX + TEVA PARENTERAL WATSON LABS WOCKHARDT

3 - 113 (of 424)

100MG/5ML 100MG/5ML

A202583 001 N020479 001

Oct 27, 2011 Feb 29, 1996

AN AN AN AN AN AN

10MG/ML 10MG/ML 10MG/ML 10MG/ML 10MG/ML 10MG/ML

A075585 A074209 A075333 A075271 A076469 A075346

001 001 001 001 001 001

Dec Apr Apr Jan Jun Oct

21, 26, 30, 18, 17, 25,

2000 1994 2002 2000 2005 1999

AT AT AT AT AT

SOLUTION/DROPS; OPHTHALMIC CROLOM BAUSCH AND LOMB 4% CROMOLYN SODIUM AKORN 4% ALCON 4% NOVEX 4% OPTICROM + ALLERGAN 4%

A074443 001 A074706 001 A075282 001 A075615 001 N018155 001

Jan 30, 1995 Apr 29, 1998 Jun 16, 1999 Jan 26, 2001 Oct 03, 1984

CROTAMITON
CREAM; TOPICAL
EURAX
XX + RANBAXY LOTION; TOPICAL CROTAN SUMMERS AT EURAX AT + RANBAXY

10%

N006927 001

10% 10%

A087204 001 N009112 003

CUPRIC CHLORIDE
INJECTABLE; INJECTION
CUPRIC CHLORIDE IN PLASTIC CONTAINER
EQ 0.4MG COPPER/ML XX + HOSPIRA

N018960 001

Jun 26, 1986

CYANOCOBALAMIN
INJECTABLE; INJECTION CYANOCOBALAMIN AP + LUITPOLD VIBISONE AP + APP PHARMS SPRAY, METERED; NASAL
NASCOBAL
XX + PAR PHARM

1MG/ML 1MG/ML

A080737 001 A080557 003

0.5MG/SPRAY

N021642 001

Jan 31, 2005

CYCLOBENZAPRINE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL AMRIX ANESTA AG AB 15MG AB + 30MG CYCLOBENZAPRINE HYDROCHLORIDE MYLAN AB 15MG AB 30MG

N021777 001 N021777 002 A090738 001 A090738 002

Feb 01, 2007 Feb 01, 2007 Apr 18, 2011 Apr 18, 2011

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

CYCLOBENZAPRINE HYDROCHLORIDE
TABLET; ORAL CYCLOBENZAPRINE HYDROCHLORIDE AUROBINDO PHARMA 5MG 10MG INVAGEN PHARMS 5MG 10MG JUBILANT CADISTA 5MG 10MG KVK TECH 5MG 10MG MUTUAL PHARM 5MG 10MG MYLAN 5MG 10MG ORIT LABS LLC 10MG PLIVA 10MG PROSAM LABS 5MG 10MG RANBAXY 5MG 7.5MG 10MG SANDOZ 5MG 10MG VINTAGE PHARMS 5MG 10MG WATSON LABS 5MG 7.5MG 10MG FLEXERIL JANSSEN R AND D 5MG + 10MG

3 - 114 (of 424)

AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB

A078643 A078643 A090478 A090478 A077563 A077563 A078048 A078048 A073541 A073541 A073144 A073144 A078218 A074421 A077291 A077209 A078722 A078722 A078722 A072854 A072854 A077797 A077797 A071611 A071611 A071611

001 002 001 002 001 002 001 002 002 001 002 001 001 001 001 001 001 002 003 002 001 001 002 002 003 001

Sep Sep Jul Jul Apr Apr Feb Feb Apr May Feb May Apr Sep Feb Oct May May May Feb Nov Feb Feb Feb Feb May

26, 26, 23, 23, 19, 19, 28, 28, 06, 23, 03, 30, 18, 29, 03, 04, 12, 12, 12, 03, 19, 28, 28, 03, 03, 03,

2008 2008 2010 2010 2006 2006 2011 2011 2006 1995 2006 1991 2008 1995 2006 2005 2008 2008 2008 2006 1991 2007 2007 2006 2006 1989

N017821 001 N017821 002

CYCLOPENTOLATE HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC AKPENTOLATE AKORN AT 1% AT 2% CYCLOGYL AT + ALCON 1% AT + 2% PENTOLAIR BAUSCH AND LOMB 1% AT CYCLOGYL 0.5% XX + ALCON

A040164 001 A040165 001 A084110 001 A084108 001 A040075 001 A084109 001

Jan 13, 1997 Jan 13, 1997

Apr 29, 1994

CYCLOPENTOLATE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE

SOLUTION/DROPS; OPHTHALMIC
CYCLOMYDRIL
0.2%;1% XX + ALCON

A084300 001

CYCLOPHOSPHAMIDE
INJECTABLE; INJECTION CYCLOPHOSPHAMIDE + BAXTER HLTHCARE + + CYTOXAN BAXTER HLTHCARE

AP AP AP AP AP

500MG/VIAL 1GM/VIAL 2GM/VIAL 500MG/VIAL 1GM/VIAL

A040745 001 A040745 002 A040745 003 N012142 003 N012142 004

May 21, 2008 May 21, 2008 May 21, 2008

Aug 30, 1982

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

CYCLOPHOSPHAMIDE
INJECTABLE; INJECTION CYTOXAN BAXTER HLTHCARE AP TABLET; ORAL CYCLOPHOSPHAMIDE ROXANE XX XX +

3 - 115 (of 424)

2GM/VIAL

N012142 005

Aug 30, 1982

25MG 50MG

A040032 001 A040032 002

Aug 17, 1999 Aug 17, 1999

CYCLOSERINE
CAPSULE; ORAL
SEROMYCIN
XX + PURDUE GMP

250MG

A060593 001

CYCLOSPORINE
CAPSULE; ORAL CYCLOSPORINE IVAX SUB TEVA PHARMS AB1 AB1 AB1 PLIVA AB1 AB1 SANDOZ AB1 AB1 GENGRAF ABBOTT AB1 AB1 AB1 NEORAL NOVARTIS AB1 AB1 + CYCLOSPORINE APOTEX AB2 AB2 SANDIMMUNE NOVARTIS AB2 AB2 + SANDIMMUNE BX NOVARTIS EMULSION; OPHTHALMIC
RESTASIS
XX + ALLERGAN INJECTABLE; INJECTION CYCLOSPORINE BEDFORD AP LUITPOLD AP SANDIMMUNE AP + NOVARTIS SOLUTION; ORAL CYCLOSPORINE ABBOTT AB1 IVAX SUB TEVA PHARMS AB1 NOVEX AB1 WATSON LABS AB1 NEORAL AB1 + NOVARTIS CYCLOSPORINE WOCKHARDT AB2

25MG 50MG 100MG 25MG 100MG 25MG 100MG 25MG 50MG 100MG 25MG 100MG 25MG 100MG 25MG 100MG 50MG

A065110 A065110 A065110 A065044 A065044 A065017 A065017

003 001 002 002 001 002 001

Mar Mar Mar Dec Dec Jan Jan

29, 29, 29, 20, 20, 13, 13,

2005 2005 2005 2000 2000 2000 2000

A065003 001 A065003 002 A065003 003 N050715 001 N050715 002 A065040 001 A065040 002 N050625 001 N050625 002 N050625 003

May 12, 2000 May 12, 2000 May 12, 2000 Jul 14, 1995 Jul 14, 1995 May 09, 2002 May 09, 2002 Mar 02, 1990 Mar 02, 1990 Nov 23, 1992

0.05%

N050790 001

Dec 23, 2002

50MG/ML 50MG/ML 50MG/ML

A065004 001 A065151 001 N050573 001

Oct 29, 1999 Oct 07, 2003 Nov 14, 1983

100MG/ML 100MG/ML 100MG/ML 100MG/ML 100MG/ML 100MG/ML

A065025 A065078 A065167 A065054

001 001 001 001

Mar Mar Jan Dec

03, 25, 05, 18,

2000 2005 2005 2001

N050716 001 A065133 001

Jul 14, 1995 Sep 17, 2004

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

CYCLOSPORINE
SOLUTION; ORAL SANDIMMUNE AB2 + NOVARTIS

3 - 116 (of 424)

100MG/ML

N050574 001

Nov 14, 1983

CYPROHEPTADINE HYDROCHLORIDE
SYRUP; ORAL CYPROHEPTADINE HYDROCHLORIDE AA + LYNE 2MG/5ML TABLET; ORAL CYPROHEPTADINE HYDROCHLORIDE COREPHARMA 4MG + IVAX SUB TEVA PHARMS 4MG PAR PHARM 4MG STASON PHARMS 4MG

A040668 001

Jun 28, 2006

AA AA AA AA

A040537 A087056 A087129 A040644

001 001 001 001

Sep 30, 2003

May 30, 2006

CYSTEAMINE BITARTRATE
CAPSULE; ORAL CYSTAGON MYLAN XX XX +

EQ 50MG BASE EQ 150MG BASE

N020392 001 N020392 002

Aug 15, 1994 Aug 15, 1994

CYTARABINE
INJECTABLE; INJECTION CYTARABINE AP + APP PHARMS BEDFORD AP AP AP AP AP + HOSPIRA AP + AP + AP ONCO THERAPIES LTD AP AP AP CYTOSAR-U TEVA PARENTERAL AP AP + AP + AP +

100MG/ML 100MG/VIAL 500MG/VIAL 1GM/VIAL 2GM/VIAL 20MG/ML 20MG/ML 20MG/ML 100MG/ML 20MG/ML 20MG/ML 20MG/ML 100MG/VIAL 500MG/VIAL 1GM/VIAL 2GM/VIAL

A076512 A071471 A071472 A074245 A074245 A071868 A072168 A072945 A075383 A200914 A200915 A200916 A075206 A075206 A075206 A075206

001 001 001 001 002 001 001 001 001 001 001 001 001 002 004 003

Jan Aug Aug Aug Aug Jun Aug Feb Nov Dec Dec Dec Dec Dec Dec Dec

15, 02, 02, 31, 31, 04, 31, 28, 22, 13, 13, 13, 30, 30, 30, 30,

2004 1989 1989 1994 1994 1990 1990 1994 1999 2011 2011 2011 1998 1998 1998 1998

INJECTABLE, LIPOSOMAL; INJECTION

DEPOCYT

10MG/ML XX + PACIRA PHARMS INC

N021041 001

Apr 01, 1999

DABIGATRAN ETEXILATE MESYLATE

CAPSULE; ORAL PRADAXA BOEHRINGER INGELHEIM XX XX +

75MG 150MG

N022512 001 N022512 002

Oct 18, 2010 Oct 18, 2010

DACARBAZINE
INJECTABLE; INJECTION DACARBAZINE APP PHARMS AP AP BEDFORD AP AP

100MG/VIAL 200MG/VIAL 200MG/VIAL 500MG/VIAL

A075371 A075371 A075812 A075812

001 002 001 002

Aug Aug Jun Oct

27, 27, 15, 31,

1999 1999 2001 2002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

DACARBAZINE
INJECTABLE; INJECTION DACARBAZINE HOSPIRA TEVA PARENTERAL + DTIC-DOME + BAYER HLTHCARE +

3 - 117 (of 424)

AP AP AP AP AP

200MG/VIAL 200MG/VIAL 500MG/VIAL 100MG/VIAL 200MG/VIAL

A075940 001 A075259 002 A075259 001 N017575 001 N017575 002

Oct 18, 2001 Aug 27, 1998 Sep 22, 2000

DACTINOMYCIN
INJECTABLE; INJECTION COSMEGEN AP + LUNDBECK INC DACTINOMYCIN BEDFORD AP

0.5MG/VIAL 0.5MG/VIAL

N050682 001 A090304 001 Mar 16, 2010

DALFAMPRIDINE
TABLET, EXTENDED RELEASE; ORAL
AMPYRA
XX + ACORDA 10MG

N022250 001

Jan 22, 2010

DALFOPRISTIN; QUINUPRISTIN
INJECTABLE; IV (INFUSION)
SYNERCID
350MG/VIAL;150MG/VIAL XX + KING PHARMS

N050748 001

Sep 21, 1999

DALTEPARIN SODIUM
INJECTABLE; SUBCUTANEOUS FRAGMIN EISAI INC XX XX XX XX XX XX XX XX XX + XX

2,500IU/0.2ML (12,500IU/ML) 5,000IU/0.2ML (25,000IU/ML) 7,500IU/0.3ML (25,000IU/ML) 10,000IU/ML (10,000IU/ML) 10,000IU/0.4ML (25,000IU/ML) 12,500IU/0.5ML (25,000IU/ML) 15,000IU/0.6ML (25,000IU/ML) 18,000IU/0.72ML (25,000IU/ML) 95,000IU/3.8ML (25,000IU/ML) 95,000IU/9.5ML (10,000IU/ML)

N020287 N020287 N020287 N020287 N020287 N020287 N020287 N020287 N020287 N020287

001 003 005 004 002 009 010 011 006 007

Dec Mar Apr Jan May May May May Apr Apr

22, 18, 04, 30, 01, 01, 01, 01, 04, 04,

1994 1996 2002 1998 2007 2007 2007 2007 2002 2002

DANAZOL
CAPSULE; ORAL DANAZOL BARR AB AB AB + LANNETT AB AB AB

50MG 100MG 200MG 50MG 100MG 200MG

A074582 A074582 A074582 A078214 A078214 A077246

003 002 001 001 002 001

May May Aug Apr Apr Sep

29, 29, 09, 19, 19, 28,

1998 1998 1996 2007 2007 2005

DANTROLENE SODIUM
CAPSULE; ORAL DANTRIUM JHP PHARMS AB AB AB + DANTROLENE SODIUM IMPAX LABS AB

25MG 50MG 100MG 25MG

N017443 001 N017443 003 N017443 002 A076856 001 Mar 01, 2005

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

DANTROLENE SODIUM
CAPSULE; ORAL DANTROLENE SODIUM IMPAX LABS AB AB INJECTABLE; INJECTION DANTRIUM AP + JHP PHARMS DANTROLENE SODIUM US WORLDMEDS AP

3 - 118 (of 424)

50MG 100MG

A076856 002 A076856 003

Mar 01, 2005

Mar 01, 2005

20MG/VIAL 20MG/VIAL

N018264 001 A078378 001 Jul 24, 2007

DAPSONE

GEL; TOPICAL

ACZONE
XX + ALLERGAN
TABLET; ORAL

DAPSONE
JACOBUS XX XX +

5%

N021794 001

Jul 07, 2005

25MG
100MG

A086841 001
A086842 001

DAPTOMYCIN
INJECTABLE; IV (INFUSION)
CUBICIN
XX + CUBIST 500MG/VIAL

N021572 002

Sep 12, 2003

DARIFENACIN HYDROBROMIDE
TABLET, EXTENDED RELEASE; ORAL ENABLEX XX WARNER CHILCOTT LLC EQ 7.5MG BASE XX + EQ 15MG BASE

N021513 001 N021513 002

Dec 22, 2004 Dec 22, 2004

DARUNAVIR ETHANOLATE

SUSPENSION; ORAL

PREZISTA
XX + TIBOTEC TABLET; ORAL PREZISTA TIBOTEC XX XX XX XX +

EQ 100MG BASE/ML

N202895 001

Dec 16, 2011

EQ EQ EQ EQ

75MG BASE 150MG BASE 400MG BASE 600MG BASE

N021976 N021976 N021976 N021976

004 005 003 002

Dec Dec Oct Feb

18, 18, 21, 25,

2008 2008 2008 2008

DASATINIB
TABLET; ORAL
SPRYCEL
BRISTOL MYERS SQUIBB XX XX XX XX XX XX +

20MG
50MG
70MG
80MG
100MG
140MG

N021986 N021986 N021986 N021986 N021986 N021986

001 002 003 005 004 006

Jun Jun Jun Oct May Oct

28, 28, 28, 28, 30, 28,

2006 2006 2006 2010 2008 2010

DAUNORUBICIN CITRATE

INJECTABLE, LIPOSOMAL; INJECTION

DAUNOXOME
EQ 2MG BASE/ML XX + GALEN (UK)

N050704 002

Apr 08, 1996

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

DAUNORUBICIN HYDROCHLORIDE
INJECTABLE; INJECTION CERUBIDINE + BEDFORD EQ DAUNORUBICIN HYDROCHLORIDE APP PHARMS EQ + BEDFORD EQ TEVA PARENTERAL EQ DAUNORUBICIN HYDROCHLORIDE APP PHARMS EQ

3 - 119 (of 424)

AP AP AP AP XX

20MG BASE/VIAL 20MG BASE/VIAL 5MG BASE/ML 5MG BASE/ML 5MG BASE/VIAL

A064103 001 A065000 001 N050731 001 A065035 001 A065034 001

Feb 03, 1995 May 25, 1999 Jan 30, 1998 Jan 24, 2000 Nov 20, 2001

DECITABINE
INJECTABLE; INTRAVENOUS
DACOGEN
XX + EISAI INC

50MG/VIAL

N021790 001

May 02, 2006

DEFERASIROX
TABLET, FOR SUSPENSION; ORAL EXJADE NOVARTIS 125MG XX 250MG XX 500MG XX +

N021882 001 N021882 002 N021882 003

Nov 02, 2005 Nov 02, 2005 Nov 02, 2005

DEFERIPRONE
TABLET; ORAL
FERRIPROX
XX + APOPHARMA INC

500MG

N021825 001

Oct 14, 2011

DEFEROXAMINE MESYLATE
INJECTABLE; INJECTION DEFEROXAMINE MESYLATE APP PHARMS AP AP BEDFORD AP AP HOSPIRA AP AP WATSON LABS AP AP DESFERAL AP + NOVARTIS AP +

500MG/VIAL 2GM/VIAL 500MG/VIAL 2GM/VIAL 500MG/VIAL 2GM/VIAL 500MG/VIAL 2GM/VIAL 500MG/VIAL 2GM/VIAL

A078718 A078718 A078086 A078086 A076019 A076019 A076806 A076806

001 002 001 002 001 002 001 002

Sep Sep May May Mar Mar Mar Mar

15, 15, 30, 30, 17, 17, 31, 31,

2009 2009 2007 2007 2004 2004 2006 2006

N016267 001 N016267 002

May 25, 2000

DEGARELIX ACETATE
POWDER; SUBCUTANEOUS FIRMAGON FERRING XX XX +

EQ 80MG BASE/VIAL EQ 120MG BASE/VIAL

N022201 001 N022201 002

Dec 24, 2008 Dec 24, 2008

DELAVIRDINE MESYLATE
TABLET; ORAL RESCRIPTOR VIIV HLTHCARE XX XX +

100MG 200MG

N020705 001 N020705 002

Apr 04, 1997 Jul 14, 1999

DEMECLOCYCLINE HYDROCHLORIDE
TABLET; ORAL DECLOMYCIN COREPHARMA AB

150MG

N050261 002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

DEMECLOCYCLINE HYDROCHLORIDE
TABLET; ORAL DECLOMYCIN AB + COREPHARMA 300MG DEMECLOCYCLINE HYDROCHLORIDE AMNEAL PHARM 150MG AB 300MG AB BARR 150MG AB 300MG AB IMPAX LABS 150MG AB 300MG AB VERSAPHARM 150MG AB 300MG AB

3 - 120 (of 424)

N050261 003 A065425 A065425 A065171 A065171 A065094 A065094 A065389 A065389 001 002 001 002 001 002 001 002 Feb Feb Dec Dec Mar Mar Dec Dec 27, 27, 13, 13, 22, 22, 01, 01, 2008 2008 2004 2004 2004 2004 2008 2008

DESFLURANE
LIQUID; INHALATION
SUPRANE
XX + BAXTER HLTHCARE CORP

99.9%

N020118 001

Sep 18, 1992

DESIPRAMINE HYDROCHLORIDE
TABLET; ORAL DESIPRAMINE HYDROCHLORIDE ACTAVIS TOTOWA 10MG 25MG 50MG 75MG 100MG 150MG SANDOZ 10MG 25MG 50MG 75MG 100MG 150MG NORPRAMIN SANOFI AVENTIS US 10MG 25MG + 50MG 75MG + 100MG 150MG

AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB

A074430 A071601 A071588 A071602 A071766 A074430 A072099 A072100 A072101 A072102 A072103 A072104 N014399 N014399 N014399 N014399 N014399 N014399

001 001 001 001 001 002 001 001 001 001 001 001 007 001 003 004 005 006

Feb Jun Jun Oct Oct Feb May May May Jun Jun Jun

09, 05, 05, 05, 05, 09, 24, 24, 24, 20, 20, 20,

1996 1987 1987 1987 1987 1996 1988 1988 1988 1988 1988 1988

Feb 11, 1982

DESIRUDIN RECOMBINANT
INJECTABLE; SUBCUTANEOUS
IPRIVASK
XX + CANYON

15MG/VIAL

N021271 001

Apr 04, 2003

DESLORATADINE
SYRUP; ORAL
CLARINEX
XX + SCHERING TABLET; ORAL CLARINEX + SCHERING PLOUGH DESLORATADINE DR REDDYS LABS LTD LUPIN PHARMS ORCHID HLTHCARE PERRIGO R AND D

0.5MG/ML

N021300 001

Sep 01, 2004

AB AB AB AB AB

5MG 5MG 5MG 5MG 5MG

N021165 001 A078365 A078352 A078357 A078361 001 001 001 001

Dec 21, 2001 Mar Oct Feb Dec 08, 25, 19, 22, 2011 2010 2010 2011

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

DESLORATADINE
TABLET; ORAL DESLORATADINE SANDOZ AB SUN PHARM INDS AB

3 - 121 (of 424)

5MG 5MG

A078364 001 A078359 001

Dec 03, 2010 Nov 16, 2010

AB AB AB AB

TABLET, ORALLY DISINTEGRATING; ORAL CLARINEX SCHERING 2.5MG + 5MG DESLORATADINE REDDYS 2.5MG 5MG

N021312 002 N021312 001 A078367 001 A078367 002

Jul 14, 2005 Jun 26, 2002 Jul 12, 2010 Jul 12, 2010

DESLORATADINE; PSEUDOEPHEDRINE SULFATE

TABLET, EXTENDED RELEASE; ORAL CLARINEX D 24 HOUR AB + SCHERING 5MG;240MG DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOUR DR REDDYS LABS LTD AB 5MG;240MG CLARINEX-D 12 HOUR XX + SCHERING 2.5MG;120MG

N021605 001 A078366 001 N021313 001

Mar 03, 2005 Apr 26, 2011 Feb 01, 2006

DESMOPRESSIN ACETATE
INJECTABLE; INJECTION DDAVP AP + SANOFI AVENTIS US DESMOPRESSIN ACETATE HOSPIRA AP TEVA PARENTERAL AP SOLUTION; NASAL
DDAVP
XX + SANOFI AVENTIS US

0.004MG/ML 0.004MG/ML 0.004MG/ML

N018938 001 A075220 001 A074888 001

Mar 30, 1984 Aug 28, 2000 Oct 15, 1997

0.01%

N017922 001

AB AB AB AB XX

SPRAY, METERED; NASAL DDAVP (NEEDS NO REFRIGERATION) + SANOFI AVENTIS US 0.01MG/SPRAY DESMOPRESSIN ACETATE + BAUSCH AND LOMB 0.01MG/SPRAY DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION) APOTEX INC 0.01MG/SPRAY MINIRIN + FERRING 0.01MG/SPRAY STIMATE (NEEDS NO REFRIGERATION) + CSL BEHRING 1.5MG/SPRAY

N017922 003 A074830 001 A076703 001 N021333 001 N020355 002

Aug 07, 1996 Jan 25, 1999 Jan 27, 2005 Sep 16, 2002 Oct 24, 2007

TABLET; ORAL DDAVP SANOFI AVENTIS US AB AB + DESMOPRESSIN ACETATE APOTEX INC AB AB TEVA PHARMS AB AB WATSON LABS AB AB DESMOPRESSIN ACETATE FERRING XX XX +

0.1MG 0.2MG 0.1MG 0.2MG 0.1MG 0.2MG 0.1MG 0.2MG 0.1MG 0.2MG

N019955 001 N019955 002 A077414 A077414 A077122 A077122 A076470 A076470 001 002 001 002 001 002

Sep 06, 1995 Sep 06, 1995 Mar Mar Jan Jan Jul Jul 07, 07, 25, 25, 01, 01, 2006 2006 2006 2006 2005 2005

N021795 001 N021795 002

May 08, 2008 May 08, 2008

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

DESOGESTREL; ETHINYL ESTRADIOL
TABLET; ORAL-28 CYCLESSA AB + ORGANON USA INC DESOGEN ORGANON USA INC DESOGESTREL AND ETHINYL DURAMED PHARMS BARR WATSON LABS EMOQUETTE VINTAGE KARIVA BARR MIRCETTE + TEVA WOMENS ORTHO-CEPT + JANSSEN PHARMS VELIVET DURAMED PHARMS BARR

3 - 122 (of 424)

0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0. 025MG 0.15MG;0.03MG ESTRADIOL 0.15MG;0.03MG 0.15MG,N/A;0.02MG,0.01MG 0.15MG;0.03MG 0.15MG;0.03MG 0.15MG,N/A;0.02MG,0.01MG 0.15MG,N/A;0.02MG,0.01MG 0.15MG;0.03MG 0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0. 025MG

N021090 001

Dec 20, 2000

AB AB AB AB AB AB AB AB AB

N020071 002 A075256 002 A076916 001 A076915 001 A076675 001 A075863 001 N020713 001 N020301 002 A076455 001

Dec 10, 1992 Aug 12, 1999 Dec 29, 2008 Jul 29, 2005 Feb 25, 2011 Apr 05, 2002 Apr 22, 1998 Dec 14, 1992 Feb 24, 2004

DESONIDE
AEROSOL, FOAM; TOPICAL
VERDESO
XX + STIEFEL LABS INC CREAM; TOPICAL DESONIDE AB + PERRIGO NEW YORK TARO AB DESOWEN GALDERMA LABS LP AB GEL; TOPICAL
DESONATE
XX + INTENDIS LOTION; TOPICAL DESONIDE ALTANA AB DESOWEN AB + GALDERMA LABS LP OINTMENT; TOPICAL DESONIDE ALTANA + PERRIGO NEW YORK TARO DESOWEN GALDERMA LABS LP

0.05%

N021978 001

Sep 19, 2006

0.05% 0.05% 0.05%

N017010 001 A073548 001 N019048 001

Jun 30, 1992 Dec 14, 1984

0.05%

N021844 001

Oct 20, 2006

0.05% 0.05%

A075860 001 A072354 001

Mar 19, 2002 Jan 24, 1992

AB AB AB AB

0.05% 0.05% 0.05% 0.05%

A075751 001 N017426 001 A074254 001 A071425 001

Mar 12, 2001 Aug 03, 1994 Jun 15, 1988

DESOXIMETASONE
CREAM; TOPICAL DESOXIMETASONE NYCOMED US AB PERRIGO NEW YORK AB AB + TARO AB TOPICORT AB + TARO PHARMS NORTH TOPICORT LP TARO PHARMS NORTH AB

0.25% 0.25% 0.05% 0.25% 0.25% 0.05%

A078369 A076510 A073210 A073193

001 001 001 001

Jun Jul Nov Nov

29, 01, 30, 30,

2010 2003 1990 1990

N017856 001 N018309 001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

DESOXIMETASONE
GEL; TOPICAL DESOXIMETASONE PERRIGO NEW YORK TARO VERSAPHARM TOPICORT + TARO PHARMS NORTH

3 - 123 (of 424)

AB AB AB AB

0.05% 0.05% 0.05% 0.05%

A077552 001 A074904 001 A090727 001 N018586 001

Jan 09, 2006 Jul 14, 1998 Mar 10, 2011 Mar 29, 1982

OINTMENT; TOPICAL DESOXIMETASONE TARO AB TOPICORT AB + TARO PHARMS NORTH TOPICORT XX + TARO PHARMS NORTH

0.25% 0.25% 0.05%

A074286 001 N018763 001 N018594 001

Jun 07, 1996 Sep 30, 1983 Jan 17, 1985

DESVENLAFAXINE SUCCINATE
TABLET, EXTENDED RELEASE; ORAL

PRISTIQ

EQ 50MG BASE XX + WYETH PHARMS INC EQ 100MG BASE XX +

N021992 001 N021992 002

Feb 29, 2008 Feb 29, 2008

DEXAMETHASONE
CONCENTRATE; ORAL

DEXAMETHASONE INTENSOL

1MG/ML XX + ROXANE ELIXIR; ORAL DEXAMETHASONE LYNE + STI PHARMA LLC VINTAGE PHARMS + WOCKHARDT

A088252 001

Sep 01, 1983

AA AA AA AA

0.5MG/5ML 0.5MG/5ML 0.5MG/5ML 0.5MG/5ML

A090891 A084754 A091188 A088254

001 001 001 001

Jul 12, 2011 May 11, 2011 Jul 27, 1983

IMPLANT; INTRAVITREAL

OZURDEX

XX + ALLERGAN SOLUTION; ORAL

DEXAMETHASONE

XX + ROXANE

0.7MG

N022315 001

Jun 17, 2009

0.5MG/5ML

A088248 001

Sep 01, 1983

SUSPENSION/DROPS; OPHTHALMIC
MAXIDEX
XX + ALCON 0.1% TABLET; ORAL DEXAMETHASONE ECR AB ROXANE AB DEXAMETHASONE BP PAR PHARM BP BP BP BP + BP ROXANE BP BP BP BP BP +

N013422 001

1.5MG 1.5MG 0.5MG 0.75MG 1.5MG 4MG 6MG 0.5MG 0.75MG 1MG 2MG 4MG 6MG

A040700 001 A084610 001 A088148 A088160 A088237 A088238 A088481 A084611 A084613 A088306 A087916 A084612 A088316 001 001 001 001 001 001 001 001 001 001 001

Aug 15, 2008

Apr Apr Apr Apr Nov

28, 28, 28, 28, 28,

1983 1983 1983 1983 1983

Sep 15, 1983 Aug 26, 1982 Sep 15, 1983

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

DEXAMETHASONE SODIUM PHOSPHATE
INJECTABLE; INJECTION DEXAMETHASONE SODIUM PHOSPHATE APP PHARMS AP EQ 4MG PHOSPHATE/ML AP EQ 10MG PHOSPHATE/ML AP EQ 10MG PHOSPHATE/ML AP + BAXTER HLTHCARE EQ 10MG PHOSPHATE/ML AP + LUITPOLD EQ 4MG PHOSPHATE/ML PFIZER AP EQ 4MG PHOSPHATE/ML AP EQ 10MG PHOSPHATE/ML SOLUTION/DROPS; OPHTHALMIC, OTIC DEXAMETHASONE SODIUM PHOSPHATE AT + ALCON UNIVERSAL EQ 0.1% PHOSPHATE BAUSCH AND LOMB AT EQ 0.1% PHOSPHATE

3 - 124 (of 424)

A084916 A040491 A040572 A087702 A087440 A040803 A040802

001 001 001 001 001 001 001

Apr Apr Sep Jul Aug Aug

11, 22, 07, 21, 29, 29,

2003 2005 1982 1982 2008 2008

A088771 001 A040069 001

Jan 16, 1985 Jul 26, 1996

DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

OINTMENT; OPHTHALMIC MAXITROL AT + FALCON PHARMS 0.1%;EQ 3.5MG NEOMYCIN AND POLYMYXIN B SULFATES AND BAUSCH AND LOMB AT 0.1%;EQ 3.5MG FERA PHARMS AT 0.1%;EQ 3.5MG SUSPENSION/DROPS; OPHTHALMIC DEXASPORIN BAUSCH AND LOMB 0.1%;EQ 3.5MG MAXITROL ALCON 0.1%;EQ 3.5MG + FALCON PHARMS 0.1%;EQ 3.5MG NEOMYCIN AND POLYMYXIN B SULFATES AND ALCON UNIVERSAL 0.1%;EQ 3.5MG

BASE/GM;10,000 UNITS/GM DEXAMETHASONE BASE/GM;10,000 UNITS/GM BASE/GM;10,000 UNITS/GM

N050065 002 A064063 001 A062938 001 Jul 25, 1994 Jul 31, 1989

AT AT AT AT

BASE/ML;10,000 UNITS/ML BASE/ML;10,000 UNITS/ML BASE/ML;10,000 UNITS/ML DEXAMETHASONE BASE/ML;10,000 UNITS/ML

A064135 001 A062341 001 N050023 002 A062721 001

Sep 13, 1995 May 22, 1984

Nov 17, 1986

DEXAMETHASONE; TOBRAMYCIN
OINTMENT; OPHTHALMIC
TOBRADEX
XX + ALCON

0.1%;0.3%

N050616 001

Sep 28, 1988

SUSPENSION/DROPS; OPHTHALMIC TOBRADEX AB + ALCON 0.1%;0.3% TOBRAMYCIN AND DEXAMETHASONE BAUSCH AND LOMB AB 0.1%;0.3% TOBRADEX ST 0.05%;0.3% XX + ALCON PHARMS LTD

N050592 001 A064134 001 N050818 001

Aug 18, 1988 Oct 27, 1999 Feb 13, 2009

DEXCHLORPHENIRAMINE MALEATE
SYRUP; ORAL
DEXCHLORPHENIRAMINE MALEATE
2MG/5ML XX + WOCKHARDT

A088251 001

Mar 23, 1984

DEXLANSOPRAZOLE
CAPSULE, DELAYED RELEASE; ORAL DEXILANT XX TAKEDA PHARMS 30MG XX + 60MG

N022287 001 N022287 002

Jan 30, 2009 Jan 30, 2009

DEXMEDETOMIDINE HYDROCHLORIDE
INJECTABLE; INJECTION
PRECEDEX
XX + HOSPIRA

EQ 100MCG BASE/ML (EQ100MCG BASE/ML)

N021038 001

Dec 17, 1999

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

DEXMETHYLPHENIDATE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL FOCALIN XR NOVARTIS 5MG XX 10MG XX 15MG XX 20MG XX 25MG XX 30MG XX 35MG XX 40MG XX + TABLET; ORAL DEXMETHYLPHENIDATE HYDROCHLORIDE TEVA PHARMS AB 2.5MG AB 5MG AB 10MG FOCALIN NOVARTIS AB 2.5MG AB 5MG AB + 10MG

3 - 125 (of 424)

N021802 N021802 N021802 N021802 N021802 N021802 N021802 N021802

001 002 004 003 008 005 007 006

May May Aug May Apr Oct Apr Aug

26, 26, 01, 26, 21, 23, 21, 11,

2005 2005 2006 2005 2011 2009 2011 2010

A077107 003 A077107 001 A077107 002 N021278 001 N021278 002 N021278 003

Jan 29, 2007 Jan 29, 2007 Jan 29, 2007 Nov 13, 2001 Nov 13, 2001 Nov 13, 2001

DEXRAZOXANE HYDROCHLORIDE
INJECTABLE; INJECTION DEXRAZOXANE HYDROCHLORIDE BEDFORD EQ EQ MYLAN INSTITUTIONAL EQ EQ ZINECARD + PHARMACIA AND UPJOHN EQ + EQ TOTECT + TOPOTARGET EQ

AP AP AP AP AP AP XX

250MG 500MG 250MG 500MG

BASE/VIAL BASE/VIAL BASE/VIAL BASE/VIAL

A076068 A076068 A200752 A200752

001 002 001 002

Sep Sep Oct Oct

28, 28, 19, 19,

2004 2004 2011 2011

250MG BASE/VIAL 500MG BASE/VIAL 500MG BASE/VIAL

N020212 001 N020212 002 N022025 001

May 26, 1995 May 26, 1995 Sep 06, 2007

DEXTROAMPHETAMINE SULFATE
CAPSULE, EXTENDED RELEASE; ORAL DEXEDRINE COREPHARMA AB 5MG AB 10MG AB + 15MG DEXTROAMPHETAMINE SULFATE BARR 5MG AB 10MG AB 15MG AB MALLINCKRODT 5MG AB 10MG AB 15MG AB SOLUTION; ORAL
DEXTROAMPHETAMINE SULFATE
5MG/5ML XX + OUTLOOK PHARMS TABLET; ORAL DEXTROAMPHETAMINE SULFATE BARR 5MG AA 10MG AA + MALLINCKRODT 5MG AA 10MG AA MIKART 5MG AA 10MG AA NESHER PHARMS 5MG AA

N017078 001 N017078 002 N017078 003 A076137 A076137 A076137 A076353 A076353 A076353 001 002 003 001 002 003 Jan Jan Jan May May May 18, 18, 18, 06, 06, 06, 2002 2002 2002 2003 2003 2003

A040776 001

Jan 29, 2008

A040361 A040361 A040436 A040436 A090533 A090533 A040365

001 002 001 002 002 004 001

Jan Jan Jan Jan Oct Oct Oct

31, 31, 29, 29, 25, 25, 31,

2001 2001 2002 2002 2011 2011 2002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

DEXTROAMPHETAMINE SULFATE
TABLET; ORAL DEXTROAMPHETAMINE SULFATE NESHER PHARMS AA 10MG DEXTROAMPHETAMINE SULFATE MIKART 2.5MG
XX 7.5MG
XX 15MG
XX 20MG
XX 30MG
XX

3 - 126 (of 424)

A040367 001 A090533 A090533 A090533 A090533 A090533 001 003 005 006 007

Oct 31, 2002 Oct Oct Oct Oct Oct 25, 25, 25, 25, 25, 2011 2011 2011 2011 2011

DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE

SYRUP; ORAL PROMETH W/ DEXTROMETHORPHAN + ACTAVIS MID ATLANTIC 15MG/5ML;6.25MG/5ML PROMETHAZINE DM VINTAGE 15MG/5ML;6.25MG/5ML PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE AMNEAL PHARMS 15MG/5ML;6.25MG/5ML HI TECH PHARMA 15MG/5ML;6.25MG/5ML PROMETHAZINE W/ DEXTROMETHORPHAN WOCKHARDT 15MG/5ML;6.25MG/5ML

AA AA AA AA AA

A088762 001 A040649 001 A090575 001 A040027 001 A088864 001

Oct 31, 1984 Feb 14, 2006 Feb 08, 2011 Jul 31, 1996 Jan 04, 1985

DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE

CAPSULE; ORAL
NUEDEXTA
XX + AVANIR PHARMS

20MG;10MG

N021879 001

Oct 29, 2010

DEXTROSE
INJECTABLE; INJECTION DEXTROSE 10% IN PLASTIC CONTAINER + B BRAUN 10GM/100ML + BAXTER HLTHCARE 10GM/100ML + HOSPIRA 10GM/100ML DEXTROSE 20% IN PLASTIC CONTAINER + BAXTER HLTHCARE 20GM/100ML + HOSPIRA 20GM/100ML DEXTROSE 30% IN PLASTIC CONTAINER + BAXTER HLTHCARE 30GM/100ML + HOSPIRA 30GM/100ML DEXTROSE 40% IN PLASTIC CONTAINER + BAXTER HLTHCARE 40GM/100ML + HOSPIRA 40GM/100ML DEXTROSE 5% IN PLASTIC CONTAINER + B BRAUN 50MG/ML + 5GM/100ML + 5GM/100ML + BAXTER HLTHCARE 50MG/ML + 50MG/ML + 5GM/100ML + 5GM/100ML + HOSPIRA 50MG/ML + 50MG/ML + 5GM/100ML + 5GM/100ML DEXTROSE 50% IN PLASTIC CONTAINER + BAXTER HLTHCARE 50GM/100ML + 50GM/100ML HOSPIRA 500MG/ML + 50GM/100ML

AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP

N019626 004 N016694 001 N018080 001 N017521 004 N018564 001 N017521 003 N019345 001 N017521 002 N018562 001 N016730 N016730 N019626 N016673 N020179 N016673 N020179 N016367 N019222 N019466 N019479 N017521 N020047 N019445 N018563 002 001 002 003 002 001 001 002 001 001 001 001 001 001 001

Feb 02, 1988

Mar 23, 1982

Jan 26, 1985

Mar 23, 1982

Feb 02, 1988 Oct 30, 1985 Dec 07, 1992 Dec 07, 1992 Jul 13, 1984 Jul 15, 1985 Sep 17, 1985

Jul 02, 1991 Jun 03, 1986 Mar 23, 1982

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

DEXTROSE
INJECTABLE; INJECTION DEXTROSE 50% IN PLASTIC + HOSPIRA DEXTROSE 60% IN PLASTIC + BAXTER HLTHCARE DEXTROSE 70% IN PLASTIC + BAXTER HLTHCARE + + HOSPIRA + DEXTROSE 25% + HOSPIRA CONTAINER 50GM/100ML CONTAINER 60GM/100ML CONTAINER 70GM/100ML 70GM/100ML 70GM/100ML 70GM/100ML 250MG/ML

3 - 127 (of 424)

AP AP AP AP AP AP XX

N019894 001 N017521 005 N017521 N020047 N018561 N019893 006 003 001 001

Dec 26, 1989 Mar 26, 1982 Mar Jul Mar Dec 26, 02, 23, 26, 1982 1991 1982 1989

N019445 002

Nov 23, 1998

DEXTROSE; MAGNESIUM ACETATE TETRAHYDRATE; POTASSIUM ACETATE; SODIUM CHLORIDE

INJECTABLE; INJECTION

PLASMA-LYTE 56 AND DEXTROSE 5% IN PLASTIC CONTAINER
BAXTER HLTHCARE 5GM/100ML;32MG/100ML;128MG/100ML;234MG/ XX
100ML

N017385 001

DEXTROSE; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE

INJECTABLE; INJECTION

NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER
HOSPIRA 5GM/100ML;21MG/100ML;128MG/100ML;234MG/ XX
100ML

N017610 001

DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE
INJECTABLE; INJECTION ISOLYTE P IN DEXTROSE 5% IN PLASTIC CONTAINER B BRAUN 5GM/100ML;31MG/100ML;130MG/100ML;26MG/1 XX 00ML;320MG/100ML

N019873 001

Jun 10, 1993

DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE; SODIUM LACTATE; SODIUM PHOSPHATE, MONOBASIC ANHYDROUS
INJECTABLE; INJECTION
IONOSOL B AND DEXTROSE 5% IN PLASTIC CONTAINER
HOSPIRA 5GM/100ML;53MG/100ML;100MG/100ML;100MG/ XX 100ML;180MG/100ML;280MG/100ML;16MG/100M L

N019515 001

May 08, 1986

DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM LACTATE

INJECTABLE; INJECTION

DEXTROSE 5% AND ELECTROLYTE NO.48 IN PLASTIC CONTAINER
BAXTER HLTHCARE 5GM/100ML;31MG/100ML;141MG/100ML;20MG/1 XX
00ML;12MG/100ML;260MG/100ML

N017484 001

DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM LACTATE; SODIUM PHOSPHATE, MONOBASIC ANHYDROUS
INJECTABLE; INJECTION IONOSOL MB AND DEXTROSE 5% IN PLASTIC CONTAINER HOSPIRA 5GM/100ML;30MG/100ML;141MG/100ML;15MG/1 XX 00ML;260MG/100ML;25MG/100ML

N019513 001

May 08, 1986

DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE

INJECTABLE; INJECTION ISOLYTE H IN DEXTROSE 5% IN PLASTIC CONTAINER B BRAUN 5GM/100ML;30MG/100ML;97MG/100ML;220MG/1 XX 00ML;140MG/100ML

N019844 001

Jun 10, 1993

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 128 (of 424)

DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE
INJECTABLE; INJECTION ISOLYTE S IN DEXTROSE 5% IN PLASTIC CONTAINER B BRAUN 5GM/100ML;30MG/100ML;37MG/100ML;370MG/1 XX 00ML;530MG/100ML;500MG/100ML NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINER HOSPIRA 5GM/100ML;30MG/100ML;37MG/100ML;222MG/1 XX 00ML;526MG/100ML;502MG/100ML PLASMA-LYTE 148 AND DEXTROSE 5% IN PLASTIC CONTAINER BAXTER HLTHCARE 5GM/100ML;30MG/100ML;37MG/100ML;368MG/1 XX 00ML;526MG/100ML;502MG/100ML

N019843 001

Aug 09, 1993

N017609 001

N017451 001

DEXTROSE; POTASSIUM CHLORIDE

INJECTABLE; INJECTION DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER BAXTER HLTHCARE 5GM/100ML;75MG/100ML DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER BAXTER HLTHCARE 5GM/100ML;150MG/100ML DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER BAXTER HLTHCARE 5GM/100ML;224MG/100ML DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER BAXTER HLTHCARE 5GM/100ML;300MG/100ML POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER B BRAUN 5GM/100ML;75MG/100ML POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER B BRAUN 5GM/100ML;150MG/100ML 5GM/100ML;150MG/100ML POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER B BRAUN 5GM/100ML;300MG/100ML 5GM/100ML;300MG/100ML POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER HOSPIRA 5GM/100ML;224MG/100ML POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER B BRAUN 5GM/100ML;220MG/100ML POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER HOSPIRA 5GM/100ML;149MG/100ML POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER HOSPIRA 5GM/100ML;298MG/100ML

AP AP AP AP AP AP AP AP AP AP XX XX XX

N017634 004 N017634 001 N017634 003 N017634 002 N018744 001 N018744 002 N019699 004 N018744 004 N019699 006 N018371 003 N018744 003 N018371 001 N018371 002 Nov 09, 1982 Nov 09, 1982 Nov 09, 1982 Sep 29, 1989 Nov 09, 1982 Sep 29, 1989

DEXTROSE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE
INJECTABLE; INJECTION ISOLYTE M IN DEXTROSE 5% IN PLASTIC CONTAINER B BRAUN 5GM/100ML;150MG/100ML;130MG/100ML;280MG XX /100ML;91MG/100ML

N019870 001

Jun 10, 1993

DEXTROSE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM LACTATE
INJECTABLE; INJECTION DEXTROSE 5% AND ELECTROLYTE NO 75 IN PLASTIC CONTAINER BAXTER HLTHCARE 5GM/100ML;205MG/100ML;100MG/100ML;120MG XX /100ML;220MG/100ML

N018840 001

Jun 29, 1983

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

INJECTABLE; INJECTION DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ BAXTER HLTHCARE AP 5GM/100ML;75MG/100ML;200MG/100ML N018037 006 AP 5GM/100ML;150MG/100ML;200MG/100ML N018037 007 DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K) BAXTER HLTHCARE AP 5GM/100ML;224MG/100ML;200MG/100ML N018037 004

Apr 13, 1982 Apr 13, 1982

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
INJECTABLE; INJECTION DEXTROSE 5%, SODIUM BAXTER HLTHCARE DEXTROSE 5%, SODIUM BAXTER HLTHCARE DEXTROSE 5%, SODIUM BAXTER HLTHCARE DEXTROSE 5%, SODIUM BAXTER HLTHCARE DEXTROSE 5%, SODIUM BAXTER HLTHCARE DEXTROSE 5%, SODIUM BAXTER HLTHCARE DEXTROSE 5%, SODIUM BAXTER HLTHCARE

3 - 129 (of 424)

AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP

CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ Apr 13, 1982 5GM/100ML;150MG/100ML;200MG/100ML N018037 008 CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ (K) 5GM/100ML;300MG/100ML;200MG/100ML N018037 001 CHLORIDE 0.2% AND POTASSIUM CHLORIDE 30MEQ Apr 13, 1982 5GM/100ML;224MG/100ML;200MG/100ML N018037 005 CHLORIDE 0.2% AND POTASSIUM CHLORIDE 40MEQ Apr 13, 1982 5GM/100ML;300MG/100ML;200MG/100ML N018037 009 CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ 5GM/100ML;75MG/100ML;200MG/100ML N018037 002 CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (K) 5GM/100ML;150MG/100ML;200MG/100ML N018037 003 CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER Mar 23, 1982 5GM/100ML;75MG/100ML;330MG/100ML N018629 005 Mar 23, 1982 5GM/100ML;150MG/100ML;330MG/100ML N018629 002 DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER BAXTER HLTHCARE Mar 23, 1982 5GM/100ML;224MG/100ML;330MG/100ML N018629 003 DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER BAXTER HLTHCARE Mar 23, 1982 5GM/100ML;150MG/100ML;330MG/100ML N018629 004 Mar 23, 1982 5GM/100ML;300MG/100ML;330MG/100ML N018629 006 DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER BAXTER HLTHCARE Mar 23, 1982 5GM/100ML;224MG/100ML;330MG/100ML N018629 007 DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER BAXTER HLTHCARE Mar 23, 1982 5GM/100ML;300MG/100ML;330MG/100ML N018629 008 DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER BAXTER HLTHCARE Mar 23, 1982 5GM/100ML;75MG/100ML;330MG/100ML N018629 001 DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC CONTAINER BAXTER HLTHCARE 5GM/100ML;300MG/100ML;450MG/100ML N018008 010 POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER B BRAUN Feb 17, 1988 5GM/100ML;75MG/100ML;200MG/100ML N019630 008 POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER B BRAUN Feb 17, 1988 5GM/100ML;75MG/100ML;330MG/100ML N019630 014 POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER B BRAUN Feb 17, 1988 5GM/100ML;75MG/100ML;450MG/100ML N019630 020 POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER B BRAUN Feb 17, 1988 5GM/100ML;75MG/100ML;900MG/100ML N019630 026 POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER B BRAUN Feb 17, 1988 5GM/100ML;150MG/100ML;200MG/100ML N019630 010 POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER B BRAUN Feb 17, 1988 5GM/100ML;150MG/100ML;330MG/100ML N019630 016 POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER B BRAUN Feb 17, 1988 5GM/100ML;150MG/100ML;450MG/100ML N019630 022 POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER B BRAUN Feb 17, 1988 5GM/100ML;150MG/100ML;900MG/100ML N019630 028 POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER B BRAUN Feb 17, 1988 5GM/100ML;300MG/100ML;200MG/100ML N019630 012 POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER B BRAUN Feb 17, 1988 5GM/100ML;300MG/100ML;330MG/100ML N019630 018 POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER B BRAUN Feb 17, 1988 5GM/100ML;300MG/100ML;450MG/100ML N019630 024 POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER B BRAUN Feb 17, 1988 5GM/100ML;300MG/100ML;900MG/100ML N019630 030 POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER BAXTER HLTHCARE Apr 28, 1982 5GM/100ML;75MG/100ML;450MG/100ML N018008 005 Apr 28, 1982 5GM/100ML;150MG/100ML;450MG/100ML N018008 006 HOSPIRA Mar 28, 1988 5GM/100ML;74.5MG/100ML;450MG/100ML N018362 005 Jul 05, 1983 5GM/100ML;74.5MG/100ML;450MG/100ML N018362 009 POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER BAXTER HLTHCARE Apr 05, 1985 5GM/100ML;75MG/100ML;900MG/100ML N019308 004

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

3 - 130 (of 424)

AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP XX XX XX XX XX XX XX XX XX XX XX

INJECTABLE; INJECTION POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER BAXTER HLTHCARE Apr 05, 1985 5GM/100ML;150MG/100ML;900MG/100ML N019308 002 HOSPIRA Mar 24, 1988 5GM/100ML;74.5MG/100ML;900MG/100ML N019691 002 Mar 24, 1988 5GM/100ML;149MG/100ML;900MG/100ML N019691 004 POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER HOSPIRA Mar 28, 1988 5GM/100ML;224MG/100ML;450MG/100ML N018362 006 POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HOSPIRA Mar 24, 1988 5GM/100ML;224MG/100ML;900MG/100ML N019691 006 POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER BAXTER HLTHCARE Apr 28, 1982 5GM/100ML;150MG/100ML;450MG/100ML N018008 007 HOSPIRA Jul 05, 1983 5GM/100ML;149MG/100ML;450MG/100ML N018362 010 Mar 28, 1988 5GM/100ML;298MG/100ML;450MG/100ML N018362 007 POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER BAXTER HLTHCARE Apr 05, 1985 5GM/100ML;150MG/100ML;900MG/100ML N019308 005 Apr 05, 1985 5GM/100ML;300MG/100ML;900MG/100ML N019308 003 HOSPIRA Mar 24, 1988 5GM/100ML;149MG/100ML;900MG/100ML N019691 005 Mar 24, 1988 5GM/100ML;298MG/100ML;900MG/100ML N019691 008 POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER BAXTER HLTHCARE Apr 28, 1982 5GM/100ML;224MG/100ML;450MG/100ML N018008 008 HOSPIRA 5GM/100ML;224MG/100ML;450MG/100ML N018362 002 POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER BAXTER HLTHCARE Apr 05, 1985 5GM/100ML;224MG/100ML;900MG/100ML N019308 006 HOSPIRA Mar 24, 1988 5GM/100ML;224MG/100ML;900MG/100ML N019691 007 POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER BAXTER HLTHCARE Apr 28, 1982 5GM/100ML;300MG/100ML;450MG/100ML N018008 009 HOSPIRA 5GM/100ML;298MG/100ML;450MG/100ML N018362 003 POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER BAXTER HLTHCARE Apr 05, 1985 5GM/100ML;300MG/100ML;900MG/100ML N019308 007 HOSPIRA Mar 24, 1988 5GM/100ML;298MG/100ML;900MG/100ML N019691 009 POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER BAXTER HLTHCARE 5GM/100ML;150MG/100ML;450MG/100ML N018008 004 HOSPIRA Mar 28, 1988 5GM/100ML;74.5MG/100ML;450MG/100ML N018362 008 Mar 28, 1988 5GM/100ML;149MG/100ML;450MG/100ML N018362 004 POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER BAXTER HLTHCARE Apr 05, 1985 5GM/100ML;150MG/100ML;900MG/100ML N019308 001 HOSPIRA Mar 24, 1988 5GM/100ML;74.5MG/100ML;900MG/100ML N019691 001 Mar 24, 1988 5GM/100ML;149MG/100ML;900MG/100ML N019691 003 POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER B BRAUN 10GM/100ML;37MG/100ML;200MG/100ML N019630 031 Feb 17, 1988 POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER B BRAUN 10GM/100ML;37MG/100ML;450MG/100ML N019630 037 Feb 17, 1988 POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER B BRAUN 10GM/100ML;37MG/100ML;900MG/100ML N019630 043 Feb 17, 1988 POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER B BRAUN 5GM/100ML;37MG/100ML;110MG/100ML N019630 001 Feb 17, 1988 POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER B BRAUN 5GM/100ML;37MG/100ML;200MG/100ML N019630 007 Feb 17, 1988 POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER B BRAUN 5GM/100ML;37MG/100ML;330MG/100ML N019630 013 Feb 17, 1988 POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER B BRAUN 5GM/100ML;37MG/100ML;450MG/100ML N019630 019 Feb 17, 1988 POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER B BRAUN 5GM/100ML;37MG/100ML;900MG/100ML N019630 025 Feb 17, 1988 POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER B BRAUN 10GM/100ML;75MG/100ML;200MG/100ML N019630 032 Feb 17, 1988 POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER B BRAUN 10GM/100ML;75MG/100ML;450MG/100ML N019630 038 Feb 17, 1988 POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER B BRAUN 10GM/100ML;75MG/100ML;900MG/100ML N019630 044 Feb 17, 1988

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
INJECTABLE; POTASSIUM B BRAUN POTASSIUM B BRAUN POTASSIUM B BRAUN POTASSIUM B BRAUN POTASSIUM B BRAUN POTASSIUM B BRAUN POTASSIUM B BRAUN POTASSIUM B BRAUN POTASSIUM B BRAUN POTASSIUM B BRAUN POTASSIUM B BRAUN POTASSIUM B BRAUN POTASSIUM B BRAUN POTASSIUM B BRAUN POTASSIUM B BRAUN POTASSIUM B BRAUN POTASSIUM B BRAUN POTASSIUM B BRAUN POTASSIUM B BRAUN POTASSIUM B BRAUN POTASSIUM B BRAUN POTASSIUM B BRAUN POTASSIUM B BRAUN POTASSIUM B BRAUN POTASSIUM B BRAUN POTASSIUM B BRAUN POTASSIUM B BRAUN POTASSIUM B BRAUN POTASSIUM B BRAUN POTASSIUM B BRAUN

3 - 131 (of 424)

XX XX XX XX XX XX XX XX XX XX XX XX XX XX XX XX XX XX XX XX XX XX XX XX XX XX XX XX XX XX

INJECTION CHLORIDE 0.075% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER 3.3GM/100ML;75MG/100ML;300MG/100ML N019630 049 May 07, 1992 CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER 5GM/100ML;75MG/100ML;110MG/100ML N019630 002 Feb 17, 1988 CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER 10GM/100ML;110MG/100ML;200MG/100ML N019630 033 Feb 17, 1988 CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 10GM/100ML;110MG/100ML;450MG/100ML N019630 039 Feb 17, 1988 CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 10GM/100ML;110MG/100ML;900MG/100ML N019630 045 Feb 17, 1988 CHLORIDE 0.11% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER 3.3GM/100ML;110MG/100ML;300MG/100ML N019630 050 May 07, 1992 CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER 5GM/100ML;110MG/100ML;110MG/100ML N019630 003 Feb 17, 1988 CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER 5GM/100ML;110MG/100ML;200MG/100ML N019630 009 Feb 17, 1988 CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER 5GM/100ML;110MG/100ML;330MG/100ML N019630 015 Feb 17, 1988 CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 5GM/100ML;110MG/100ML;450MG/100ML N019630 021 Feb 17, 1988 CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 5GM/100ML;110MG/100ML;900MG/100ML N019630 027 Feb 17, 1988 CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER 10GM/100ML;150MG/100ML;200MG/100ML N019630 034 Feb 17, 1988 CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 10GM/100ML;150MG/100ML;450MG/100ML N019630 040 Feb 17, 1988 CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 10GM/100ML;150MG/100ML;900MG/100ML N019630 046 Feb 17, 1988 CHLORIDE 0.15% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER 3.3GM/100ML;150MG/100ML;300MG/100ML N019630 051 May 07, 1992 CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER 5GM/100ML;150MG/100ML;110MG/100ML N019630 004 Feb 17, 1988 CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER 10GM/100ML;220MG/100ML;200MG/100ML N019630 035 Feb 17, 1988 CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 10GM/100ML;220MG/100ML;450MG/100ML N019630 041 Feb 17, 1988 CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 10GM/100ML;220MG/100ML;900MG/100ML N019630 047 Feb 17, 1988 CHLORIDE 0.22% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER 3.3GM/100ML;220MG/100ML;300MG/100ML N019630 052 May 07, 1992 CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER 5GM/100ML;220MG/100ML;110MG/100ML N019630 005 Feb 17, 1988 CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER 5GM/100ML;220MG/100ML;200MG/100ML N019630 011 Feb 17, 1988 CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER 5GM/100ML;220MG/100ML;330MG/100ML N019630 017 Feb 17, 1988 CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 5GM/100ML;220MG/100ML;450MG/100ML N019630 023 Feb 17, 1988 CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 5GM/100ML;220MG/100ML;900MG/100ML N019630 029 Feb 17, 1988 CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER 10GM/100ML;300MG/100ML;200MG/100ML N019630 036 Feb 17, 1988 CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 10GM/100ML;300MG/100ML;450MG/100ML N019630 042 Feb 17, 1988 CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 10GM/100ML;300MG/100ML;900MG/100ML N019630 048 Feb 17, 1988 CHLORIDE 0.3% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER 3.3GM/100ML;300MG/100ML;300MG/100ML N019630 053 May 07, 1992 CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER 5GM/100ML;300MG/100ML;110MG/100ML N019630 006 Feb 17, 1988

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

3 - 132 (of 424)

INJECTABLE; INJECTION POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER HOSPIRA 5GM/100ML;74.5MG/100ML;225MG/100ML N018365 002 Jul 05, XX 5GM/100ML;149MG/100ML;225MG/100ML N018365 006 Mar 28, XX POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER HOSPIRA 5GM/100ML;74.5MG/100ML;300MG/100ML N018876 001 Jan 17, XX 5GM/100ML;149MG/100ML;300MG/100ML N018876 006 Mar 28, XX POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER HOSPIRA 5GM/100ML;224MG/100ML;225MG/100ML N018365 008 Mar 28, XX POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER HOSPIRA 5GM/100ML;224MG/100ML;300MG/100ML N018876 007 Mar 28, XX POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER HOSPIRA 5GM/100ML;149MG/100ML;225MG/100ML N018365 001 XX 5GM/100ML;298MG/100ML;225MG/100ML N018365 009 Mar 28, XX POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER HOSPIRA 5GM/100ML;298MG/100ML;300MG/100ML N018876 008 Mar 28, XX POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER HOSPIRA 5GM/100ML;149MG/100ML;300MG/100ML N018876 002 Jan 17, XX POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER HOSPIRA 5GM/100ML;224MG/100ML;225MG/100ML N018365 003 Jul 05, XX POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER HOSPIRA 5GM/100ML;224MG/100ML;300MG/100ML N018876 003 Jan 17, XX POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER HOSPIRA 5GM/100ML;298MG/100ML;225MG/100ML N018365 004 Jul 05, XX POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER HOSPIRA 5GM/100ML;298MG/100ML;300MG/100ML N018876 004 Mar 28, XX POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER HOSPIRA 5GM/100ML;74.5MG/100ML;225MG/100ML N018365 005 Mar 28, XX 5GM/100ML;149MG/100ML;225MG/100ML N018365 007 Mar 28, XX POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER HOSPIRA 5GM/100ML;74.5MG/100ML;300MG/100ML N018876 005 Mar 28, XX 5GM/100ML;149MG/100ML;300MG/100ML N018876 009 Mar 28, XX

1983 1988 1986 1988 1988 1988

1988 1988 1986 1983 1986 1983 1988 1988 1988 1988 1988

DEXTROSE; SODIUM CHLORIDE

INJECTABLE; INJECTION DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER B BRAUN 10GM/100ML;900MG/100ML BAXTER HLTHCARE 10GM/100ML;900MG/100ML DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER B BRAUN 2.5GM/100ML;450MG/100ML BAXTER HLTHCARE 2.5GM/100ML;450MG/100ML DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER B BRAUN 5GM/100ML;200MG/100ML DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER B BRAUN 5GM/100ML;330MG/100ML DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER B BRAUN 5GM/100ML;450MG/100ML HOSPIRA 5GM/100ML;450MG/100ML DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER B BRAUN 5GM/100ML;900MG/100ML HOSPIRA 5GM/100ML;900MG/100ML DEXTROSE 5% IN SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER BAXTER HLTHCARE 5GM/100ML;200MG/100ML DEXTROSE 5% IN SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER BAXTER HLTHCARE 5GM/100ML;330MG/100ML DEXTROSE 5% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER BAXTER HLTHCARE 5GM/100ML;450MG/100ML DEXTROSE 5% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER BAXTER HLTHCARE 5GM/100ML;900MG/100ML

AP AP AP AP AP AP AP AP AP AP AP AP AP AP

N019631 015 N016696 001 N019631 004 N016697 001 N019631 007 N019631 008 N019631 009 N017607 001 N019631 010 N017585 001 N016689 001 N016687 001 N016683 001 N016678 001

Feb 24, 1988

Feb 24, 1988

Feb 24, 1988 Feb 24, 1988 Feb 24, 1988

Feb 24, 1988

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

DEXTROSE; SODIUM CHLORIDE
INJECTABLE; INJECTION DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER B BRAUN 10GM/100ML;110MG/100ML DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER B BRAUN 10GM/100ML;200MG/100ML DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER B BRAUN 10GM/100ML;330MG/100ML DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER B BRAUN 10GM/100ML;450MG/100ML DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER B BRAUN 2.5GM/100ML;110MG/100ML DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER B BRAUN 2.5GM/100ML;200MG/100ML DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER B BRAUN 2.5GM/100ML;330MG/100ML DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER B BRAUN 2.5GM/100ML;900MG/100ML DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER B BRAUN 3.3GM/100ML;300MG/100ML DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER B BRAUN 5GM/100ML;110MG/100ML DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER HOSPIRA 5GM/100ML;225MG/100ML DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER HOSPIRA 5GM/100ML;300MG/100ML

3 - 133 (of 424)

XX XX XX XX XX XX XX XX XX XX XX XX

N019631 011 N019631 012 N019631 013 N019631 014 N019631 001 N019631 002 N019631 003 N019631 005 N019631 016 N019631 006 N017606 001 N017799 001

Feb 24, 1988 Feb 24, 1988 Feb 24, 1988 Feb 24, 1988 Feb 24, 1988 Feb 24, 1988 Feb 24, 1988 Feb 24, 1988 Jan 19, 1990 Feb 24, 1988

DIATRIZOATE MEGLUMINE
SOLUTION; URETHRAL CYSTOGRAFIN XX BRACCO CYSTOGRAFIN DILUTE XX BRACCO

30% 18%

N010040 018 N010040 022 Nov 09, 1982

DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM

INJECTABLE; INJECTION MD-76R AP + MALLINCKRODT RENOGRAFIN-76 AP + BRACCO SOLUTION; ORAL, RECTAL GASTROGRAFIN AA + BRACCO MD-GASTROVIEW MALLINCKRODT AA

66%;10% 66%;10%

N019292 001 N010040 001

Sep 29, 1989

66%;10% 66%;10%

N011245 003 A087388 001

DIATRIZOATE MEGLUMINE; IODIPAMIDE MEGLUMINE

SOLUTION; INTRAUTERINE SINOGRAFIN XX + BRACCO

52.7%;26.8%

N011324 002

DIAZEPAM
CONCENTRATE; ORAL DIAZEPAM INTENSOL XX + ROXANE GEL; RECTAL DIASTAT VALEANT XX DIASTAT ACUDIAL VALEANT XX

5MG/ML

A071415 001

Apr 03, 1987

2.5MG/0.5ML (5MG/ML) 10MG/2ML (5MG/ML)

N020648 001 N020648 007

Jul 29, 1997

Sep 15, 2005

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

DIAZEPAM
GEL; RECTAL

DIASTAT ACUDIAL

XX + VALEANT INJECTABLE; INJECTION DIAZEPAM AP + HOSPIRA AP AP WATSON LABS AP SOLUTION; ORAL

DIAZEPAM

XX + ROXANE TABLET; ORAL DIAZEPAM BARR AB AB DAVA PHARMS INC AB IVAX SUB TEVA PHARMS AB AB AB MYLAN AB AB AB VINTAGE PHARMS AB AB AB WATSON LABS AB AB AB VALIUM ROCHE AB AB AB +

3 - 134 (of 424)

20MG/4ML (5MG/ML)

N020648 006

Sep 15, 2005

5MG/ML 5MG/ML 5MG/ML 5MG/ML

A071583 A071584 A072079 A070296

001 001 001 001

Oct Oct Dec Feb

13, 13, 20, 12,

1987 1987 1988 1986

5MG/5ML

A070928 001

Apr 03, 1987

2MG 10MG 2MG 2MG 5MG 10MG 2MG 5MG 10MG 2MG 5MG 10MG 2MG 5MG 10MG 2MG 5MG 10MG

A070152 A070154 A070226 A071307 A071321 A071322 A070325 A070325 A070325 A077749 A077749 A077749 A071134 A071135 A071136

001 001 001 001 001 001 002 003 001 001 002 003 001 001 001

Nov Nov Sep Dec Dec Dec Sep Sep Sep Mar Mar Mar Feb Feb Feb

01, 01, 26, 10, 10, 10, 04, 04, 04, 31, 31, 31, 03, 03, 03,

1985 1985 1985 1986 1986 1986 1985 1985 1985 2006 2006 2006 1987 1987 1987

N013263 002 N013263 004 N013263 006

DIAZOXIDE

SUSPENSION; ORAL

PROGLYCEM
XX + TEVA GLOBAL

50MG/ML

N017453 001

DICLOFENAC EPOLAMINE

PATCH; TOPICAL

FLECTOR
XX + INST BIOCHEM

1.3%

N021234 001

Jan 31, 2007

DICLOFENAC POTASSIUM

CAPSULE; ORAL

ZIPSOR
XX + XANODYNE PHARM
FOR SOLUTION; ORAL

CAMBIA
XX + NAUTILUS NEUROSCIENC TABLET; ORAL CATAFLAM + NOVARTIS DICLOFENAC POTASSIUM APOTEX MYLAN SANDOZ

25MG

N022202 001

Jun 16, 2009

50MG

N022165 001

Jun 17, 2009

AB AB AB AB

50MG 50MG 50MG 50MG

N020142 002 A076561 001 A075463 001 A075229 001

Nov 24, 1993 Mar 18, 2004 Jul 26, 1999 Nov 20, 1998

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

DICLOFENAC POTASSIUM
TABLET; ORAL DICLOFENAC POTASSIUM TEVA AB

3 - 135 (of 424)

50MG

A075219 001

Aug 06, 1998

DICLOFENAC SODIUM
GEL; TOPICAL

SOLARAZE

XX + FOUGERA PHARMS VOLTAREN XX + NOVARTIS SOLUTION; TOPICAL

PENNSAID

XX + MALLINCKRODT

3% 1%

N021005 001 N022122 001

Oct 16, 2000 Oct 17, 2007

1.5%

N020947 001

Nov 04, 2009

AT AT AT AT AT AT

SOLUTION/DROPS; OPHTHALMIC DICLOFENAC SODIUM AKORN 0.1% ALCON PHARMS LTD 0.1% APOTEX INC 0.1% BAUSCH AND LOMB 0.1% NEXUS PHARMS 0.1% VOLTAREN + NOVARTIS 0.1%

A077845 A078031 A077600 A078792 A078553

001 001 001 001 001

Apr Feb Nov Dec Dec

17, 06, 13, 28, 28,

2008 2008 2008 2007 2007

N020037 001

Mar 28, 1991

TABLET, DELAYED RELEASE; ORAL DICLOFENAC SODIUM ACTAVIS ELIZABETH AB 50MG AB 75MG ALPHAPHARM AB 50MG AB 75MG CARLSBAD AB 25MG AB 50MG AB 75MG AB + SANDOZ 25MG AB + 50MG AB + 75MG UNIQUE PHARM LABS AB 25MG AB 50MG AB 75MG TABLET, EXTENDED RELEASE; DICLOFENAC SODIUM ACTAVIS ELIZABETH DEXCEL LTD MYLAN VALEANT INTL VOLTAREN-XR + NOVARTIS ORAL 100MG 100MG 100MG 100MG 100MG

A074514 A074514 A075281 A075281 A075185 A075185 A075185 A074376 A074376 A074394 A090066 A090066 A077863

001 002 002 003 002 003 001 001 002 001 001 002 003

Mar Mar Feb Feb Nov Nov Nov Sep Sep Nov Dec Dec Jun

26, 26, 12, 12, 13, 13, 13, 28, 28, 30, 01, 01, 08,

1996 1996 2002 2002 1998 1998 1998 1995 1995 1995 2010 2010 2007

AB AB AB AB AB

A075910 A076201 A076152 A075492

001 001 001 001

Jan Nov Dec Feb

07, 06, 13, 11,

2002 2002 2001 2000

N020254 001

Mar 08, 1996

DICLOFENAC SODIUM; MISOPROSTOL

TABLET, DELAYED RELEASE; ORAL ARTHROTEC GD SEARLE LLC 50MG;0.2MG XX 75MG;0.2MG XX +

N020607 001 N020607 002

Dec 24, 1997 Dec 24, 1997

DICLOXACILLIN SODIUM
CAPSULE; ORAL DICLOXACILLIN SODIUM SANDOZ AB AB + TEVA AB

EQ 250MG BASE EQ 500MG BASE EQ 250MG BASE

A061454 001 A061454 003 A062286 001

Jun 03, 1982

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

DICLOXACILLIN SODIUM
CAPSULE; ORAL DICLOXACILLIN SODIUM TEVA AB DICLOXACILLIN SODIUM SANDOZ XX

3 - 136 (of 424)

EQ 500MG BASE EQ 125MG BASE

A062286 002 A061454 002

Jun 03, 1982

DICYCLOMINE HYDROCHLORIDE
CAPSULE; ORAL BENTYL + APTALIS PHARMA US 10MG DICYCLOMINE HYDROCHLORIDE LANNETT 10MG MYLAN 10MG WATSON LABS 10MG WEST WARD 10MG

AB AB AB AB AB

N007409 003 A084285 A040319 A085082 A040204 001 001 001 001

Oct 15, 1984

Sep 07, 1999 Jun 19, 1986 Feb 28, 1997

INJECTABLE; INJECTION BENTYL AP + APTALIS PHARMA US 10MG/ML BENTYL PRESERVATIVE FREE AP + APTALIS PHARMA US 10MG/ML DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE-FREE) BEDFORD AP 10MG/ML SYRUP; ORAL BENTYL AA + APTALIS PHARMA US 10MG/5ML DICYCLOMINE HYDROCHLORIDE MIKART AA 10MG/5ML TABLET; ORAL BENTYL + APTALIS PHARMA US 20MG DICYCLOMINE HYDROCHLORIDE LANNETT 20MG MYLAN 20MG WATSON LABS 20MG WEST WARD 20MG

N008370 001 N008370 002 A040465 001

Oct 15, 1984 Oct 15, 1984 Jun 30, 2003

N007961 002 A040169 001

Oct 15, 1984 Mar 24, 2005

AB AB AB AB AB

N007409 001 A040230 A040317 A085223 A040161 001 001 001 001

Oct 15, 1984 Feb Sep Jul Oct 26, 07, 30, 01, 1999 1999 1986 1996

DIDANOSINE
CAPSULE, DELAYED REL PELLETS; ORAL DIDANOSINE AUROBINDO PHARMA 125MG AB 200MG AB 250MG AB 400MG AB BARR 200MG AB 250MG AB 400MG AB MATRIX LABS LTD 125MG AB 200MG AB 250MG AB 400MG AB VIDEX EC BRISTOL MYERS SQUIBB 125MG AB 200MG AB 250MG AB 400MG AB + FOR SOLUTION; ORAL DIDANOSINE AUROBINDO PHARMA AA

A090094 A090094 A090094 A090094 A077167 A077167 A077167 A090788 A090788 A090788 A090788 N021183 N021183 N021183 N021183

001 002 003 004 001 002 003 001 002 003 004 001 002 003 004

Sep Sep Sep Sep Dec Dec Dec Apr Apr Apr Apr Oct Oct Oct Oct

24, 24, 24, 24, 03, 03, 03, 08, 08, 08, 08, 31, 31, 31, 31,

2008 2008 2008 2008 2004 2004 2004 2010 2010 2010 2010 2000 2000 2000 2000

10MG/ML

A078112 001

Mar 08, 2007

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

DIDANOSINE
FOR SOLUTION; ORAL
VIDEX
AA + BRISTOL MYERS SQUIBB

3 - 137 (of 424)

10MG/ML

N020156 001

Oct 09, 1991

DIENOGEST; ESTRADIOL VALERATE

TABLET; ORAL-28
NATAZIA
XX + BAYER HLTHCARE

N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A

N022252 001

May 06, 2010

DIETHYLPROPION HYDROCHLORIDE
TABLET; ORAL DIETHYLPROPION HYDROCHLORIDE AVANTHI INC 25MG COREPHARMA 25MG LANNETT HOLDINGS INC 25MG TENUATE + WATSON PHARMS 25MG

AA AA AA AA

A201212 001 A040828 001 A200177 001 N011722 002

Dec 22, 2010 Nov 05, 2008 Jul 18, 2011

TABLET, EXTENDED RELEASE; ORAL DIETHYLPROPION HYDROCHLORIDE LANNETT HOLDINGS INC 75MG AB TENUATE DOSPAN AB + WATSON PHARMS 75MG

A091680 001 N012546 001

Oct 24, 2011

DIFLORASONE DIACETATE
CREAM; TOPICAL DIFLORASONE DIACETATE AB1 + ALTANA TARO AB1 DIFLORASONE DIACETATE BX + ALTANA OINTMENT; TOPICAL DIFLORASONE DIACETATE ALTANA AB AB + TARO

0.05% 0.05% 0.05%

A075187 001 A075508 001 A076263 001

Mar 30, 1998 Apr 24, 2000 Dec 20, 2002

0.05% 0.05%

A075374 001 A075331 001

Apr 27, 1999 May 14, 1999

DIFLUNISAL
TABLET; ORAL
DIFLUNISAL
XX + TEVA

500MG

A073673 001

Jul 31, 1992

DIFLUPREDNATE
EMULSION; OPHTHALMIC
DUREZOL
XX + ALCON PHARMS LTD

0.05%

N022212 001

Jun 23, 2008

DIGOXIN
ELIXIR; ORAL
DIGOXIN
XX + ROXANE INJECTABLE; INJECTION DIGOXIN BAXTER HLTHCARE HOSPIRA SANDOZ LANOXIN + COVIS PHARMA LANOXIN PEDIATRIC + COVIS PHARMA

0.05MG/ML

N021648 001

Aug 26, 2004

AP AP AP AP XX

0.25MG/ML 0.25MG/ML 0.25MG/ML 0.25MG/ML 0.1MG/ML

A083391 001 A040093 001 A040481 001 N009330 002 N009330 004

May 16, 1996 Aug 21, 2003

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

DIGOXIN
TABLET; ORAL DIGOXIN CARACO AB AB IMPAX LABS AB AB STEVENS J AB AB WEST WARD AB AB LANOXIN COVIS PHARMA AB AB +

3 - 138 (of 424)

0.125MG 0.25MG 0.125MG 0.25MG 0.125MG 0.25MG 0.125MG 0.25MG 0.125MG 0.25MG

A076363 A076363 A078556 A078556 A076268 A076268 A077002 A077002

001 002 001 002 001 002 002 001

Jan Jan Jul Jul Jul Jul Oct Oct

31, 31, 20, 20, 26, 26, 30, 30,

2003 2003 2009 2009 2002 2002 2007 2007

N020405 002 N020405 004

Sep 30, 1997 Sep 30, 1997

DIHYDROERGOTAMINE MESYLATE
INJECTABLE; INJECTION D.H.E. 45 AP + VALEANT 1MG/ML DIHYDROERGOTAMINE MESYLATE BEDFORD LABS AP 1MG/ML PADDOCK LLC AP 1MG/ML
SPRAY, METERED; NASAL

MIGRANAL
XX + VALEANT

N005929 001 A040453 001 A040475 001 Jun 09, 2003 Apr 28, 2003

0.5MG/INH

N020148 001

Dec 08, 1997

DILTIAZEM HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL DILACOR XR WATSON LABS AB2 120MG AB2 180MG AB2 + 240MG DILTIAZEM HYDROCHLORIDE APOTEX AB2 120MG AB2 180MG AB2 240MG MYLAN AB2 120MG AB2 180MG AB2 240MG WATSON LABS FLORIDA AB2 120MG AB2 180MG AB2 240MG CARDIZEM CD VALEANT INTL AB3 120MG AB3 180MG AB3 240MG AB3 300MG AB3 + 360MG CARTIA XT WATSON LABS FLORIDA AB3 120MG AB3 180MG AB3 240MG AB3 300MG DILT-CD APOTEX AB3 120MG AB3 180MG AB3 240MG AB3 300MG DILTIAZEM HYDROCHLORIDE ACTAVIS ELIZABETH AB3 120MG

N020092 001 N020092 002 N020092 003 A074943 A074943 A074943 A075124 A075124 A075124 A074852 A074852 A074852 N020062 N020062 N020062 N020062 N020062 A074752 A074752 A074752 A074752 A076151 A076151 A076151 A076151 003 002 001 002 003 001 001 002 003 001 002 003 004 005 002 001 003 004 001 002 003 004

May 29, 1992 May 29, 1992 May 29, 1992 Dec Dec Aug Mar Mar Mar Oct Oct Oct Aug Dec Dec Dec Aug Jul Jul Jul Jul May May May May 19, 19, 06, 18, 18, 18, 10, 10, 10, 10, 27, 27, 27, 24, 09, 09, 09, 09, 20, 20, 20, 20, 2000 2000 1998 1998 1998 1998 1997 1997 1997 1992 1991 1991 1991 1999 1998 1998 1998 1998 2004 2004 2004 2004

A074984 001

Dec 20, 1999

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

DILTIAZEM HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL DILTIAZEM HYDROCHLORIDE ACTAVIS ELIZABETH AB3 180MG AB3 240MG AB3 300MG SUN PHARMA GLOBAL AB3 120MG AB3 180MG AB3 240MG AB3 300MG AB3 360MG VALEANT INTL AB3 120MG AB3 180MG AB3 240MG AB3 300MG DILTIAZEM HYDROCHLORIDE NESHER PHARMS AB4 120MG AB4 180MG AB4 240MG AB4 300MG AB4 360MG AB4 420MG SUN PHARMA GLOBAL AB4 120MG AB4 180MG AB4 240MG AB4 300MG AB4 360MG DILTZAC APOTEX INC AB4 120MG AB4 180MG AB4 240MG AB4 300MG AB4 360MG TAZTIA XT WATSON LABS FLORIDA AB4 120MG AB4 180MG AB4 240MG AB4 300MG AB4 360MG TIAZAC VALEANT INTL AB4 120MG AB4 180MG AB4 240MG AB4 300MG AB4 360MG AB4 + 420MG DILTIAZEM HYDROCHLORIDE BC + MYLAN 120MG DILTIAZEM HYDROCHLORIDE MYLAN 60MG XX 90MG XX INJECTABLE; INJECTION DILTIAZEM HYDROCHLORIDE APOTEX INC BAXTER HLTHCARE + BEDFORD HOSPIRA INTL MEDICATION TAYLOR PHARMA TEVA PARENTERAL

3 - 139 (of 424)

A074984 A074984 A074984 A090492 A090492 A090492 A090492 A090492 A075116 A075116 A075116 A075116 A076563 A076563 A076563 A076563 A076563 A076563 A090421 A090421 A090421 A090421 A090421 A076395 A076395 A076395 A076395 A076395 A075401 A075401 A075401 A075401 A075401 N020401 N020401 N020401 N020401 N020401 N020401

002 003 004 001 002 003 004 005 001 002 003 004 002 003 004 005 006 001 001 002 003 004 005 001 002 003 004 005 001 002 003 004 005 001 002 003 004 005 006

Dec Dec Dec Oct Oct Oct Oct Oct Dec Dec Dec Dec Sep Sep Sep Sep Sep Sep Nov Nov Nov Nov Nov Feb Feb Feb Feb Feb Apr Apr Apr Apr Apr Sep Sep Sep Sep Sep Oct

20, 20, 20, 28, 28, 28, 28, 28, 23, 23, 23, 23, 12, 12, 12, 12, 12, 12, 15, 15, 15, 15, 15, 01, 01, 01, 01, 01, 10, 10, 10, 10, 10, 11, 11, 11, 11, 11, 16,

1999 1999 1999 2011 2011 2011 2011 2011 1999 1999 1999 1999 2006 2006 2006 2006 2006 2006 2010 2010 2010 2010 2010 2006 2006 2006 2006 2006 2003 2003 2003 2003 2003 1995 1995 1995 1995 1995 1998

A074910 003 A074910 001 A074910 002

May 02, 1997 May 02, 1997 May 02, 1997

AP AP AP AP AP AP AP

5MG/ML 5MG/ML 5MG/ML 5MG/ML 5MG/ML 5MG/ML 5MG/ML

A075375 A078538 A074617 A074941 A075749 A075086 A074894

001 001 001 001 001 001 001

Sep Dec Feb Apr Nov Apr Aug

30, 17, 28, 15, 21, 09, 26,

1999 2008 1996 1998 2001 1998 1997

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

DILTIAZEM HYDROCHLORIDE
INJECTABLE; INJECTION

DILTIAZEM HYDROCHLORIDE

100MG/VIAL XX + HOSPIRA 10MG/ML XX + TEVA PARENTERAL TABLET; ORAL CARDIZEM VALEANT INTL AB AB AB AB + DILTIAZEM HYDROCHLORIDE DAVA PHARMS INC AB AB AB AB MYLAN AB AB AB AB TEVA AB AB AB AB

3 - 140 (of 424)

A075853 001 A074894 002

Dec 17, 2002 Apr 19, 2002

30MG 60MG 90MG 120MG 30MG 60MG 90MG 120MG 30MG 60MG 90MG 120MG 30MG 60MG 90MG 120MG

N018602 N018602 N018602 N018602 A074093 A074093 A074093 A074093 A072838 A072838 A072838 A072838 A074185 A074185 A074185 A074185

001 002 003 004 001 002 003 004 004 003 002 001 001 002 003 004

Nov Nov Dec Dec Nov Nov Nov Nov Nov Nov Nov Nov May May May May

05, 05, 08, 08, 05, 05, 05, 05, 05, 05, 05, 05, 31, 31, 31, 31,

1982 1982 1986 1986 1992 1992 1992 1992 1992 1992 1992 1992 1995 1995 1995 1995

TABLET, EXTENDED RELEASE; ORAL CARDIZEM LA VALEANT INTL AB 120MG AB 180MG AB 240MG AB 300MG AB 360MG AB + 420MG DILTIAZEM HYDROCHLORIDE WATSON LABS FLORIDA AB 120MG AB 180MG AB 240MG AB 300MG AB 360MG AB 420MG

N021392 N021392 N021392 N021392 N021392 N021392 A077686 A077686 A077686 A077686 A077686 A077686

001 002 003 004 005 006 006 005 004 003 002 001

Feb Feb Feb Feb Feb Feb Mar Mar Mar Mar Mar Mar

06, 06, 06, 06, 06, 06, 15, 15, 15, 15, 15, 15,

2003 2003 2003 2003 2003 2003 2010 2010 2010 2010 2010 2010

DIMENHYDRINATE
INJECTABLE; INJECTION DIMENHYDRINATE APP PHARMS AP AP + WATSON LABS

50MG/ML 50MG/ML

A040519 001 A080615 001

Jun 23, 2004

DIMERCAPROL

INJECTABLE; INJECTION

BAL
XX + AKORN

10%

N005939 001

DIMETHYL SULFOXIDE
SOLUTION; INTRAVESICAL DIMETHYL SULFOXIDE BIONICHE PHARMA AT RIMSO-50 AT + BIONICHE PHARMA

50% 50%

A076185 001 N017788 001

Nov 29, 2002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

DINOPROSTONE
GEL; ENDOCERVICAL

PREPIDIL

XX + PHARMACIA AND UPJOHN

3 - 141 (of 424)

0.5MG/3GM

N019617 001

Dec 09, 1992

INSERT, EXTENDED RELEASE; VAGINAL

CERVIDIL

10MG XX + CONTROLLED THERAP SUPPOSITORY; VAGINAL

PROSTIN E2

XX + PHARMACIA AND UPJOHN

N020411 001

Mar 30, 1995

20MG

N017810 001

DIPHENHYDRAMINE HYDROCHLORIDE
CAPSULE; ORAL

DIPHENHYDRAMINE HYDROCHLORIDE

50MG XX + BARR ELIXIR; ORAL

DIPHENHYDRAMINE HYDROCHLORIDE

12.5MG/5ML XX + PHARM ASSOC INJECTABLE; INJECTION BENADRYL + MCNEIL CONS 50MG/ML BENADRYL PRESERVATIVE FREE + MCNEIL CONS 50MG/ML DIPHENHYDRAMINE HYDROCHLORIDE APP PHARMS 50MG/ML BAXTER HLTHCARE 50MG/ML BIONICHE PHARMA 50MG/ML HOSPIRA 50MG/ML WATSON LABS 50MG/ML DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE INTL MEDICATION 50MG/ML WATSON LABS 50MG/ML DIPHENHYDRAMINE HYDROCHLORIDE + WATSON LABS 10MG/ML

A080738 001

A087513 001

Feb 10, 1982

AP AP AP AP AP AP AP AP AP XX

N006146 002 N009486 001 A040466 A080817 A040498 A040140 A080873 001 002 001 001 002 May 28, 2002 Jul 12, 2005 Nov 20, 1998

A084094 001 A080873 003 A080873 001

DIPIVEFRIN HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC AKPRO AKORN AT 0.1% DIPIVEFRIN HYDROCHLORIDE FALCON PHARMS AT 0.1% PROPINE AT + ALLERGAN 0.1%

A074382 001 A073636 001 N018239 001

Sep 29, 1995 Jun 30, 1994

DIPYRIDAMOLE
INJECTABLE; INJECTION DIPYRIDAMOLE APP PHARMS BAXTER HLTHCARE + BEDFORD CLARIS LIFESCIENCES TEVA PARENTERAL

AP AP AP AP AP

5MG/ML 5MG/ML 5MG/ML 5MG/ML 5MG/ML

A074956 A074521 A074939 A075769 A074952

001 001 001 001 001

Sep Oct Apr Nov Nov

30, 18, 13, 27, 26,

1998 1996 1998 2002 1997

TABLET; ORAL DIPYRIDAMOLE BARR AB AB AB GLENMARK GENERICS AB AB

25MG 50MG 75MG 25MG 50MG

A087184 A087716 A087717 A088999 A089000

001 001 001 001 001

Oct Oct Oct Feb Feb

03, 03, 03, 05, 05,

1990 1990 1990 1991 1991

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

DIPYRIDAMOLE
TABLET; ORAL DIPYRIDAMOLE GLENMARK GENERICS AB IMPAX LABS AB AB AB LANNETT AB AB AB MURTY PHARMS AB AB AB PROSAM LABS AB AB AB PUREPAC PHARM AB WATSON LABS AB ZYDUS PHARMS USA INC AB AB AB PERSANTINE BOEHRINGER INGELHEIM AB AB AB +

3 - 142 (of 424)

75MG 25MG 50MG 75MG 25MG 50MG 75MG 25MG 50MG 75MG 25MG 50MG 75MG 25MG 50MG 25MG 50MG 75MG 25MG 50MG 75MG

A089001 A040782 A040782 A040782 A040898 A040898 A040898 A040733 A040733 A040733 A040542 A040542 A040542 A089425 A087160 A040874 A040874 A040874

001 001 002 003 001 002 003 001 002 003 001 002 003 001 001 001 002 003

Feb Jul Jul Jul Apr Apr Apr Feb Feb Feb Apr Apr Apr Jul Jun Jan Jan Jan

05, 18, 18, 18, 23, 23, 23, 13, 13, 13, 21, 21, 21, 12, 07, 28, 28, 28,

1991 2007 2007 2007 2008 2008 2008 2007 2007 2007 2006 2006 2006 1990 1996 2008 2008 2008

N012836 003 N012836 004 N012836 005

Dec 22, 1986 Feb 06, 1987 Feb 06, 1987

DISOPYRAMIDE PHOSPHATE
CAPSULE; ORAL DISOPYRAMIDE PHOSPHATE TEVA AB AB WATSON LABS AB AB NORPACE GD SEARLE LLC AB AB +

EQ EQ EQ EQ

100MG 150MG 100MG 150MG

BASE BASE BASE BASE

A070101 A070102 A070173 A070174

001 001 001 001

Feb Feb May May

22, 22, 31, 31,

1985 1985 1985 1985

EQ 100MG BASE EQ 150MG BASE

N017447 001 N017447 002

CAPSULE, EXTENDED RELEASE; ORAL DISOPYRAMIDE PHOSPHATE NESHER PHARMS AB EQ 150MG BASE NORPACE CR AB + GD SEARLE LLC EQ 150MG BASE NORPACE CR GD SEARLE LLC EQ 100MG BASE XX

A071200 001 N018655 002 N018655 001

Dec 15, 1987 Jul 20, 1982 Jul 20, 1982

DISULFIRAM
TABLET; ORAL ANTABUSE ODYSSEY PHARMS AB AB + DISULFIRAM SIGMAPHARM LABS LLC AB AB

250MG 500MG 250MG 500MG

A088482 001 A088483 001 A091619 001 A091619 002

Dec 08, 1983 Dec 08, 1983 Mar 28, 2011 Mar 28, 2011

DIVALPROEX SODIUM
CAPSULE, DELAYED REL PELLETS; ORAL DEPAKOTE AB + ABBOTT EQ 125MG VALPROIC ACID DIVALPROEX SODIUM DR REDDYS LABS LTD AB EQ 125MG VALPROIC ACID MYLAN AB EQ 125MG VALPROIC ACID

N019680 001 A078979 001 A090407 001

Sep 12, 1989 Jan 23, 2009 Mar 28, 2011

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

DIVALPROEX SODIUM
CAPSULE, DELAYED REL PELLETS; ORAL DIVALPROEX SODIUM ZYDUS PHARMS USA INC EQ 125MG VALPROIC ACID AB TABLET, DELAYED RELEASE; ORAL DEPAKOTE ABBOTT AB EQ 125MG VALPROIC ACID AB EQ 250MG VALPROIC ACID AB + EQ 500MG VALPROIC ACID DIVALPROEX SODIUM ANCHEN PHARMS AB EQ 500MG VALPROIC ACID AUROBINDO PHARMA LTD EQ 125MG VALPROIC ACID AB AB EQ 250MG VALPROIC ACID AB EQ 500MG VALPROIC ACID DR REDDYS LABS LTD AB EQ 125MG VALPROIC ACID AB EQ 250MG VALPROIC ACID AB EQ 500MG VALPROIC ACID LUPIN AB EQ 125MG VALPROIC ACID AB EQ 250MG VALPROIC ACID AB EQ 500MG VALPROIC ACID MYLAN AB EQ 125MG VALPROIC ACID AB EQ 125MG VALPROIC ACID AB EQ 250MG VALPROIC ACID AB EQ 250MG VALPROIC ACID AB EQ 500MG VALPROIC ACID AB EQ 500MG VALPROIC ACID NU PHARM AB EQ 125MG VALPROIC ACID AB EQ 250MG VALPROIC ACID AB EQ 500MG VALPROIC ACID ORCHID HLTHCARE AB EQ 125MG VALPROIC ACID AB EQ 250MG VALPROIC ACID AB EQ 500MG VALPROIC ACID SANDOZ AB EQ 125MG VALPROIC ACID AB EQ 250MG VALPROIC ACID AB EQ 500MG VALPROIC ACID SUN PHARM INDS AB EQ 125MG VALPROIC ACID AB EQ 250MG VALPROIC ACID AB EQ 500MG VALPROIC ACID TEVA AB EQ 125MG VALPROIC ACID AB EQ 250MG VALPROIC ACID AB EQ 500MG VALPROIC ACID UNICHEM LABS LTD AB EQ 125MG VALPROIC ACID AB EQ 250MG VALPROIC ACID AB EQ 500MG VALPROIC ACID UPSHER SMITH AB EQ 125MG VALPROIC ACID AB EQ 250MG VALPROIC ACID AB EQ 500MG VALPROIC ACID VINTAGE AB EQ 125MG VALPROIC ACID AB EQ 250MG VALPROIC ACID AB EQ 500MG VALPROIC ACID WATSON LABS FLORIDA AB EQ 500MG VALPROIC ACID WOCKHARDT AB EQ 125MG VALPROIC ACID AB EQ 250MG VALPROIC ACID AB EQ 500MG VALPROIC ACID ZYDUS PHARMS USA INC EQ 125MG VALPROIC ACID AB AB EQ 250MG VALPROIC ACID AB EQ 500MG VALPROIC ACID TABLET, EXTENDED RELEASE; ORAL DEPAKOTE ER ABBOTT AB EQ 250MG VALPROIC ACID

3 - 143 (of 424)

A078919 001

Jan 27, 2009

N018723 003 N018723 001 N018723 002 A078411 A090554 A090554 A090554 A078755 A078755 A078755 A078790 A078790 A078790 A077254 A090062 A077254 A090062 A077254 A090062 A077615 A077615 A077615 A078853 A078853 A078853 A078290 A078290 A078290 A078597 A078597 A078597 A076941 A076941 A076941 A079163 A079163 A079163 A078182 A078182 A078182 A090210 A090210 A090210 A079080 A077296 A077296 A077296 A077100 A077100 A077100 001 001 002 003 001 002 003 001 002 003 001 001 002 002 003 003 003 002 001 001 002 003 003 002 001 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 001 001 002 003 001 002 003

Oct 26, 1984 Mar 10, 1983 Mar 10, 1983 Nov Apr Apr Apr Jul Jul Jul Jul Jul Jul Jul Mar Jul Mar Jul Mar Jul Jul Jul Nov Nov Nov Jul Jul Jul Jul Jul Jul Jul Jul Jul Apr Apr Apr Jul Jul Jul Nov Nov Nov Feb Jul Jul Jul Mar Mar Mar 03, 21, 21, 21, 29, 29, 29, 29, 29, 29, 29, 17, 29, 17, 29, 17, 29, 29, 29, 25, 25, 25, 29, 29, 29, 29, 29, 29, 29, 29, 29, 05, 05, 05, 29, 29, 29, 30, 30, 30, 25, 31, 31, 31, 05, 05, 05, 2008 2011 2011 2011 2008 2008 2008 2008 2008 2008 2008 2009 2008 2009 2008 2009 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2011 2011 2011 2008 2008 2008 2009 2009 2009 2011 2008 2008 2008 2009 2009 2009

N021168 002

May 31, 2002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

DIVALPROEX SODIUM
TABLET, EXTENDED RELEASE; ORAL DEPAKOTE ER AB + ABBOTT EQ 500MG DIVALPROEX SODIUM ANCHEN PHARMS AB EQ 250MG AB EQ 500MG IMPAX LABS AB EQ 250MG AB EQ 500MG MYLAN AB EQ 250MG AB EQ 500MG TEVA PHARMS AB EQ 500MG WOCKHARDT AB EQ 250MG AB EQ 500MG ZYDUS PHARMS USA INC EQ 250MG AB AB EQ 500MG

3 - 144 (of 424)

VALPROIC ACID VALPROIC VALPROIC VALPROIC VALPROIC VALPROIC VALPROIC VALPROIC VALPROIC VALPROIC VALPROIC VALPROIC ACID ACID ACID ACID ACID ACID ACID ACID ACID ACID ACID

N021168 001 A078445 A078445 A078791 A078791 A077567 A077567 A078700 A078705 A078705 A078239 A078239 001 002 001 002 001 002 001 002 001 001 002

Aug 04, 2000 Feb Aug May Aug Jan Jan Aug Feb Aug Feb Aug 26, 04, 06, 04, 29, 29, 03, 10, 04, 27, 04, 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009

DOBUTAMINE HYDROCHLORIDE
INJECTABLE; INJECTION DOBUTAMINE HYDROCHLORIDE BEDFORD EQ 12.5MG BASE/ML HOSPIRA EQ 12.5MG BASE/ML + EQ 12.5MG BASE/ML WATSON LABS EQ 12.5MG BASE/ML DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% + HOSPIRA EQ 50MG BASE/100ML + EQ 100MG BASE/100ML + EQ 200MG BASE/100ML DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER + BAXTER HLTHCARE EQ 50MG BASE/100ML + EQ 100MG BASE/100ML + EQ 200MG BASE/100ML + EQ 400MG BASE/100ML + HOSPIRA EQ 50MG BASE/100ML + EQ 100MG BASE/100ML + EQ 200MG BASE/100ML + EQ 400MG BASE/100ML

AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP

A074277 A074086 A074292 A074114

001 001 001 001

Oct Nov Feb Nov

31, 29, 16, 30,

1994 1993 1995 1993

N020269 001 N020269 002 N020269 003 N020255 N020255 N020255 N020255 N020201 N020201 N020201 N020201 001 003 004 005 003 002 001 006

Oct 19, 1993 Oct 19, 1993 Oct 19, 1993 Oct Oct Oct Oct Oct Oct Oct Jul 19, 19, 19, 19, 19, 19, 19, 07, 1993 1993 1993 1993 1993 1993 1993 1994

DOCETAXEL
INJECTABLE; INJECTION DOCETAXEL + HOSPIRA INC + + SANDOZ SANDOZ INC DOCEFREZ + SUN PHARMA GLOBAL + DOCETAXEL ACCORD HLTHCARE TAXOTERE + SANOFI AVENTIS US +

AP AP AP AP AP AP XX XX XX XX XX XX

20MG/2ML (10MG/ML) 80MG/8ML (10MG/ML) 160MG/16ML (10MG/ML) 20MG/2ML (10MG/ML) 160MG/16ML (10MG/ML) 80MG/8ML (10MG/ML) 20MG/VIAL 80MG/VIAL 20MG/0.5ML (40MG/ML) 80MG/2ML (40MG/ML) 20MG/ML (20MG/ML) 80MG/4ML (20MG/ML)

N022234 N022234 N022234 N201525 N201525 N201525

001 002 003 001 003 002

Mar Mar Mar Jun Jun Jun

08, 08, 08, 29, 29, 29,

2011 2011 2011 2011 2011 2011

N022534 001 N022534 002 N201195 001 N201195 002 N020449 003 N020449 004

May 03, 2011 May 03, 2011 Jun 08, 2011 Jun 08, 2011 Aug 03, 2010 Aug 02, 2010

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

DOFETILIDE
CAPSULE; ORAL TIKOSYN PFIZER XX XX XX +

3 - 145 (of 424)

0.125MG 0.25MG 0.5MG

N020931 001 N020931 002 N020931 003

Oct 01, 1999 Oct 01, 1999 Oct 01, 1999

DOLASETRON MESYLATE
INJECTABLE; INJECTION

ANZEMET

XX + SANOFI AVENTIS US XX + XX + TABLET; ORAL ANZEMET SANOFI AVENTIS US XX XX +

12.5MG/0.625ML (20MG/ML) 100MG/5ML (20MG/ML) 500MG/25ML (20MG/ML)

N020624 002 N020624 001 N020624 003

Sep 11, 1997 Sep 11, 1997 Dec 11, 2001

50MG 100MG

N020623 001 N020623 002

Sep 11, 1997 Sep 11, 1997

DONEPEZIL HYDROCHLORIDE
TABLET; ORAL ARICEPT EISAI INC AB 5MG AB + 10MG DONEPEZIL HYDROCHLORIDE ACCORD HLTHCARE AB 5MG AB 10MG ACTAVIS PHARMA AB 5MG AB 10MG APOTEX AB 5MG AB 10MG AUROBINDO AB 5MG AB 10MG CIPLA LTD AB 5MG AB 10MG DR REDDYS LABS LTD AB 5MG AB 10MG HIKMA PHARMS AB 5MG AB 10MG HUAHAI US INC AB 5MG AB 10MG JUBILANT LIFE AB 5MG AB 10MG MATRIX LABS LTD AB 5MG AB 10MG PLIVA HRVATSKA DOO AB 5MG AB 10MG RANBAXY AB 5MG AB 10MG ROXANE AB 5MG AB 10MG SANDOZ AB 5MG AB 10MG SUN PHARM INDS AB 5MG AB 10MG TEVA AB 5MG AB 10MG TORRENT PHARMS AB 5MG AB 10MG WOCKHARDT AB 5MG AB 10MG

N020690 002 N020690 001 A201335 A201335 A090551 A090551 A078841 A078841 A090056 A090056 A077518 A077518 A201001 A201001 A090247 A090247 A200292 A200292 A090768 A090768 A090521 A090521 A090425 A090425 A076786 A076786 A078662 A078662 A090290 A090290 A090493 A090493 A077344 A077344 A090686 A090686 A091267 A091267 001 002 001 002 001 002 001 002 001 002 001 002 001 002 001 002 001 002 001 002 001 002 001 002 001 002 001 002 001 002 001 002 001 002 001 002

Nov 25, 1996 Nov 25, 1996 Aug Aug May May Jun Jun May May May May May May May May May May May May May May May May Nov Nov May May May May May May May May May May May May 29, 29, 31, 31, 02, 02, 31, 31, 31, 31, 31, 31, 31, 31, 31, 31, 31, 31, 31, 31, 31, 31, 26, 26, 31, 31, 31, 31, 31, 31, 31, 31, 31, 31, 31, 31, 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2010 2010 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

DONEPEZIL HYDROCHLORIDE
TABLET; ORAL

ARICEPT

XX + EISAI INC

3 - 146 (of 424)

23MG

N022568 001

Jul 23, 2010

AB AB AB AB AB AB AB AB

TABLET, ORALLY DISINTEGRATING; ORAL ARICEPT ODT EISAI INC 5MG + 10MG DONEPEZIL HYDROCHLORIDE BARR 5MG 10MG SANDOZ 5MG 10MG ZYDUS PHARMS USA INC 5MG 10MG

N021720 001 N021720 002 A078388 A078388 A091198 A091198 A090175 A090175 002 001 001 002 001 002

Oct 18, 2004 Oct 18, 2004 Nov Nov May May May May 26, 26, 10, 10, 10, 10, 2010 2010 2011 2011 2011 2011

DOPAMINE HYDROCHLORIDE
INJECTABLE; INJECTION DOPAMINE HYDROCHLORIDE + HOSPIRA + + + + LUITPOLD + + DOPAMINE HYDROCHLORIDE + B BRAUN + DOPAMINE HYDROCHLORIDE + B BRAUN DOPAMINE HYDROCHLORIDE + BAXTER HLTHCARE + + + HOSPIRA + + DOPAMINE HYDROCHLORIDE + B BRAUN DOPAMINE HYDROCHLORIDE + BAXTER HLTHCARE

AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP XX XX

40MG/ML 80MG/100ML 80MG/ML 160MG/100ML 40MG/ML 80MG/ML 160MG/ML AND DEXTROSE 5% 80MG/100ML 320MG/100ML AND DEXTROSE 5% IN PLASTIC CONTAINER 160MG/100ML IN DEXTROSE 5% IN PLASTIC CONTAINER 80MG/100ML 160MG/100ML 320MG/100ML 80MG/100ML 160MG/100ML 320MG/100ML AND DEXTROSE 5% IN PLASTIC CONTAINER 40MG/100ML IN DEXTROSE 5% IN PLASTIC CONTAINER 640MG/100ML

N018132 N018132 N018132 N018132 A070799 A070820 A070826

001 002 004 003 001 001 001

Feb Jul Feb Feb Feb Feb

04, 09, 04, 11, 11, 11,

1982 1982 1982 1987 1987 1987

N019099 002 N019099 004 N019099 003 N019615 N019615 N019615 N018826 N018826 N018826 001 002 003 001 002 003

Oct 15, 1986 Oct 15, 1986 Oct 15, 1986 Mar Mar Mar Sep Sep Sep 27, 27, 27, 30, 30, 30, 1987 1987 1987 1983 1983 1983

N019099 001 N019615 004

Oct 15, 1986 Mar 27, 1987

DORIPENEM
INJECTABLE; IV (INFUSION) DORIBAX JANSSEN PHARMS 250MG/VIAL XX XX + 500MG/VIAL

N022106 002 N022106 001

Oct 05, 2010 Oct 12, 2007

DORZOLAMIDE HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC DORZOLAMIDE HYDROCHLORIDE ALCON PHARMS LTD EQ APOTEX INC EQ BAUSCH AND LOMB EQ HI TECH PHARMA EQ LUITPOLD EQ SANDOZ EQ TEVA PHARMS EQ

AT AT AT AT AT AT AT

2% 2% 2% 2% 2% 2% 2%

BASE BASE BASE BASE BASE BASE BASE

A078981 A078395 A090143 A077846 A079186 A078748 A078756

001 001 001 001 001 001 001

Apr Oct Jun Oct Nov Nov Dec

13, 28, 25, 28, 18, 06, 04,

2009 2008 2009 2008 2009 2008 2008

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

DORZOLAMIDE HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC TRUSOPT AT + MERCK EQ 2% BASE

3 - 147 (of 424)

N020408 001

Dec 09, 1994

DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE

SOLUTION/DROPS; OPHTHALMIC COSOPT + MERCK EQ 2% DORZOLAMIDE HYDROCHLORIDE AND ALCON RES EQ 2% APOTEX INC EQ 2% BAUSCH AND LOMB EQ 2% HI TECH PHARMA EQ 2% SANDOZ EQ 2% TEVA PARNTL EQ 2%

AT AT AT AT AT AT AT

BASE;EQ TIMOLOL BASE;EQ BASE;EQ BASE;EQ BASE;EQ BASE;EQ BASE;EQ

0.5% BASE MALEATE 0.5% BASE 0.5% BASE 0.5% BASE 0.5% BASE 0.5% BASE 0.5% BASE

N020869 001 A090604 A078201 A090037 A077847 A078749 A078704 001 001 001 001 001 001

Apr 07, 1998 Nov Oct Jul Oct Nov Sep 18, 28, 14, 28, 06, 28, 2009 2008 2009 2008 2008 2009

DOXAPRAM HYDROCHLORIDE
INJECTABLE; INJECTION DOPRAM AP + BAXTER HLTHCARE DOXAPRAM HYDROCHLORIDE BEDFORD AP WATSON LABS AP

20MG/ML 20MG/ML 20MG/ML

N014879 001 A076266 001 A073529 001 Jan 10, 2003 Jan 30, 1992

DOXAZOSIN MESYLATE
TABLET; ORAL CARDURA AB + PFIZER AB AB AB DOXAZOSIN MESYLATE APOTEX AB AB AB AB DAVA PHARMS INC AB AB AB AB MYLAN AB AB AB AB NESHER PHARMS AB AB AB AB PLIVA AB AB AB AB TEVA AB AB AB AB WATSON LABS AB AB AB

EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ

1MG 2MG 4MG 8MG 1MG 2MG 4MG 8MG 1MG 2MG 4MG 8MG 1MG 2MG 4MG 8MG 1MG 2MG 4MG 8MG 1MG 2MG 4MG 8MG 1MG 2MG 4MG 8MG 1MG 2MG 4MG

BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE

N019668 N019668 N019668 N019668 A075580 A075580 A075580 A075580 A076161 A076161 A076161 A076161 A075509 A075509 A075509 A075509 A075609 A075609 A075609 A075609 A075750 A075750 A075750 A075750 A075536 A075536 A075536 A075536 A075426 A075426 A075426

001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003

Nov Nov Nov Nov Oct Oct Oct Oct Jun Jun Jun Jun Oct Oct Oct Oct Oct Oct Oct Oct Jun Jun Jun Jun Oct Oct Oct Oct Oct Oct Oct

02, 02, 02, 02, 18, 18, 18, 18, 10, 10, 10, 10, 19, 19, 19, 19, 18, 18, 18, 18, 08, 08, 08, 08, 18, 18, 18, 18, 18, 18, 18,

1990 1990 1990 1990 2000 2000 2000 2000 2004 2004 2004 2004 2000 2000 2000 2000 2000 2000 2000 2000 2001 2001 2001 2001 2000 2000 2000 2000 2000 2000 2000

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

DOXAZOSIN MESYLATE
TABLET; ORAL DOXAZOSIN MESYLATE WATSON LABS AB

3 - 148 (of 424)

EQ 8MG BASE

A075426 004

Oct 18, 2000

TABLET, EXTENDED RELEASE; ORAL CARDURA XL PFIZER EQ 4MG BASE XX EQ 8MG BASE XX +

N021269 001 N021269 002

Feb 22, 2005 Feb 22, 2005

DOXEPIN HYDROCHLORIDE
CAPSULE; ORAL DOXEPIN HYDROCHLORIDE MYLAN AB AB AB AB AB PAR PHARM AB AB + AB AB AB + WATSON LABS AB AB AB AB AB DOXEPIN HYDROCHLORIDE PAR PHARM XX CONCENTRATE; ORAL DOXEPIN HYDROCHLORIDE PHARM ASSOC SILARX + TEVA PHARMS WOCKHARDT

EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ

10MG BASE 25MG BASE 50MG BASE 75MG BASE 100MG BASE 10MG BASE 25MG BASE 50MG BASE 75MG BASE 100MG BASE 10MG BASE 25MG BASE 50MG BASE 75MG BASE 100MG BASE

A070791 A070791 A070791 A070791 A070791 A071697 A071437 A071595 A071608 A071422 A071485 A071486 A071238 A071326 A071239

002 003 001 004 005 001 001 001 001 001 001 001 001 001 001

May May May May May Nov Nov Nov Nov Nov Apr Apr Apr Apr Apr

13, 13, 13, 13, 13, 09, 09, 09, 09, 09, 30, 30, 30, 30, 30,

1986 1986 1986 1986 1986 1987 1987 1987 1987 1987 1987 1987 1987 1987 1987

EQ 150MG BASE

A071669 001

Nov 09, 1987

AA AA AA AA

EQ EQ EQ EQ

10MG 10MG 10MG 10MG

BASE/ML BASE/ML BASE/ML BASE/ML

A075924 A074721 A071609 A071918

001 001 001 001

Jan Dec Nov Jul

15, 29, 09, 20,

2004 1998 1987 1988

CREAM; TOPICAL

ZONALON
XX + NYCOMED US TABLET; ORAL SILENOR SOMAXON XX XX +

5%

N020126 001

Apr 01, 1994

EQ 3MG BASE EQ 6MG BASE

N022036 001 N022036 002

Mar 17, 2010 Mar 17, 2010

DOXERCALCIFEROL
CAPSULE; ORAL DOXERCALCIFEROL ROXANE HECTOROL GENZYME CORP HECTOROL GENZYME CORP +

AB AB XX XX

0.5MCG 0.5MCG 1MCG 2.5MCG

A091433 001 N020862 002 N020862 003 N020862 001

Sep 23, 2011 Apr 23, 2004 Jul 13, 2009 Jun 09, 1999

INJECTABLE; INJECTION HECTOROL GENZYME CORP XX XX +

2MCG/ML (2MCG/ML) 4MCG/2ML (2MCG/ML)

N021027 002 N021027 001

Apr 06, 2000 Apr 06, 2000

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

DOXORUBICIN HYDROCHLORIDE
INJECTABLE; INJECTION DOXORUBICIN HYDROCHLORIDE APP PHARMS 2MG/ML + BEDFORD 2MG/ML + 10MG/VIAL + 20MG/VIAL + 50MG/VIAL + 200MG/100ML ONCO THERAPIES LTD 10MG/VIAL 50MG/VIAL PHARMACHEMIE 2MG/ML 10MG/VIAL 20MG/VIAL 50MG/VIAL 200MG/100ML TEVA PARENTERAL 2MG/ML 200MG/100ML

3 - 149 (of 424)

AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP

A063277 A062975 A062921 A062921 A062921 A064097 A200170 A200170 A063336 A063097 A063097 A063097 A063336 A064140 A064140

001 001 001 002 003 001 001 002 001 001 002 003 004 001 002

Oct Mar Mar Mar Mar Sep Oct Oct Feb May May May Feb Jul Jul

26, 17, 17, 17, 17, 13, 28, 28, 28, 21, 21, 21, 28, 28, 28,

1995 1989 1989 1989 1989 1994 2011 2011 1995 1990 1990 1990 1995 1995 1995

INJECTABLE, LIPOSOMAL; INJECTION

DOXIL
20MG/10ML (2MG/ML) XX + ORTHO BIOTECH 50MG/25ML (2MG/ML) XX +

N050718 001 N050718 002

Nov 17, 1995 Jun 13, 2000

DOXYCYCLINE
CAPSULE; ORAL DOXYCYCLINE IMPAX LABS INC AB MYLAN AB PAR PHARM AB AB AB + RANBAXY AB AB AB SANDOZ AB AB WATSON LABS AB AB MONODOX WATSON PHARMS AB AB AB + ORACEA AB + GALDERMA LABS LP FOR SUSPENSION; ORAL DOXYCYCLINE IVAX SUB TEVA PHARMS AB VIBRAMYCIN AB + PFIZER TABLET; ORAL DOXYCYCLINE HERITAGE PHARMS INC AB AB AB AB LANNETT AB AB AB AB MYLAN AB

EQ 150MG BASE 40MG EQ 50MG BASE EQ 100MG BASE EQ 150MG BASE EQ 50MG BASE EQ 75MG BASE EQ 100MG BASE EQ 50MG BASE EQ 100MG BASE EQ 50MG BASE EQ 100MG BASE EQ 50MG BASE EQ 75MG BASE EQ 100MG BASE 40MG

A200065 A090855 A065055 A065055 A065055 A065053 A065053 A065053 A065032 A065032 A065041 A065041

001 001 001 002 003 001 003 002 001 002 001 002

Feb Jul Dec Dec Jul Nov Sep Nov Jun Jun Apr Apr

17, 01, 01, 01, 15, 22, 10, 22, 30, 30, 28, 28,

2011 2010 2000 2000 2005 2000 2003 2000 2000 2000 2000 2000

N050641 002 N050641 003 N050641 001 N050805 001

Feb 10, 1992 Oct 18, 2006 Dec 29, 1989 May 26, 2006

EQ 25MG BASE/5ML EQ 25MG BASE/5ML

A065454 001 N050006 001

Jul 16, 2008

EQ EQ EQ EQ EQ EQ EQ EQ EQ

50MG BASE 75MG BASE 100MG BASE 150MG BASE 50MG BASE 75MG BASE 100MG BASE 150MG BASE 50MG BASE

A091605 A091605 A091605 A091605 A065285 A065285 A065285 A065285 A065377

001 002 003 004 001 003 002 004 001

Dec Dec Dec Dec Dec Jul Dec Jul Nov

20, 20, 20, 20, 08, 30, 08, 30, 07,

2011 2011 2011 2011 2005 2008 2005 2008 2006

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

DOXYCYCLINE
TABLET; ORAL DOXYCYCLINE MYLAN AB AB AB PAR PHARM AB AB AB AB + RANBAXY AB AB AB SANDOZ AB AB AB

3 - 150 (of 424)

EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ

75MG BASE 100MG BASE 150MG BASE 50MG BASE 75MG BASE 100MG BASE 150MG BASE 50MG BASE 75MG BASE 100MG BASE 50MG BASE 75MG BASE 100MG BASE

A065377 A065377 A065427 A065070 A065070 A065070 A065070 A065356 A065356 A065356 A065353 A065353 A065353

002 003 001 001 003 002 004 001 002 003 001 002 003

Nov Nov Jun Dec Dec Dec Jul May May May Nov Nov Nov

07, 07, 07, 15, 30, 15, 14, 31, 31, 31, 27, 27, 27,

2006 2006 2007 2000 2002 2000 2005 2006 2006 2006 2006 2006 2006

DOXYCYCLINE CALCIUM
SUSPENSION; ORAL

VIBRAMYCIN

XX + PFIZER

EQ 50MG BASE/5ML

N050480 001

DOXYCYCLINE HYCLATE
CAPSULE; ORAL DOXYCYCLINE HYCLATE IVAX SUB TEVA PHARMS AB AB MUTUAL PHARM AB AB WATSON LABS FLORIDA AB AB WEST WARD AB AB VIBRAMYCIN PFIZER AB AB + DOXYCYCLINE HYCLATE XX + WEST WARD

EQ EQ EQ EQ EQ EQ EQ EQ

50MG BASE 100MG BASE 50MG BASE 100MG BASE 50MG BASE 100MG BASE 50MG BASE 100MG BASE

A062500 A062500 A062675 A062676 A062031 A062031 A062396 A062396

001 002 001 001 002 001 002 001

Sep Sep Jul Jul Oct

11, 11, 10, 10, 13,

1984 1984 1986 1986 1982

Nov 07, 1984 May 07, 1984

EQ 50MG BASE EQ 100MG BASE EQ 20MG BASE

N050007 001 N050007 002 A065103 001 May 13, 2005

CAPSULE, DELAYED RELEASE; ORAL DOXYCYCLINE HYCLATE MEDICIS EQ 75MG BASE XX EQ 100MG BASE XX + INJECTABLE; INJECTION DOXY 100 AP + APP PHARMS DOXYCYCLINE AP + BEDFORD DOXY 200 XX + APP PHARMS

A065281 001 A065281 002

Dec 21, 2005 Dec 21, 2005

EQ 100MG BASE/VIAL EQ 100MG BASE/VIAL EQ 200MG BASE/VIAL

A062475 001 A062569 001 A062475 002

Dec 09, 1983 Mar 09, 1988 Dec 09, 1983

SYSTEM, EXTENDED RELEASE; PERIODONTAL

ATRIDOX

50MG XX + TOLMAR TABLET; ORAL DOXYCYCLINE HYCLATE COREPHARMA AB IVAX SUB TEVA PHARMS AB AB LANNETT AB MUTUAL PHARM AB

N050751 001

Sep 03, 1998

EQ EQ EQ EQ EQ

20MG BASE 20MG BASE 100MG BASE 20MG BASE 100MG BASE

A065182 A065163 A062505 A065277 A062677

001 001 001 001 001

May May Sep Nov Jul

13, 13, 11, 10, 10,

2005 2005 1984 2005 1986

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

DOXYCYCLINE HYCLATE
TABLET; ORAL DOXYCYCLINE HYCLATE MUTUAL PHARMA VINTAGE PHARMS WATSON LABS + WEST-WARD PHARM CORP PERIOSTAT + GALDERMA LABS LP

3 - 151 (of 424)

AB AB AB AB AB

EQ EQ EQ EQ

20MG BASE 100MG BASE 100MG BASE 100MG BASE

A065134 A062538 A062421 A065095

001 001 001 001

May Apr Feb Jul

13, 07, 02, 02,

2005 1986 1983 2003

EQ 20MG BASE

N050783 001

Feb 02, 2001

TABLET, DELAYED RELEASE; ORAL DORYX MAYNE PHARMA AB EQ 75MG BASE AB EQ 100MG BASE DOXYCYCLINE HYCLATE ACTAVIS ELIZABETH AB EQ 75MG BASE AB EQ 100MG BASE IMPAX LABS INC AB EQ 75MG BASE AB EQ 100MG BASE MYLAN AB EQ 75MG BASE AB EQ 100MG BASE DORYX EQ 150MG BASE XX + MAYNE PHARMA

N050795 001 N050795 002 A090134 A090134 A090505 A090505 A090431 A090431 001 002 001 002 001 002

May 06, 2005 May 06, 2005 Dec Dec Dec Dec Dec Dec 14, 14, 28, 28, 28, 28, 2011 2011 2010 2010 2010 2010

N050795 003

Jun 20, 2008

DRONABINOL
CAPSULE; ORAL DRONABINOL INSYS THERAP AB AB AB SVC PHARMA AB AB AB MARINOL ABBOTT PRODS AB AB + AB

2.5MG 5MG 10MG 2.5MG 5MG 10MG 2.5MG 5MG 10MG

A078501 A078501 A078501 A078292 A078292 A078292

001 002 003 001 002 003

Aug Aug Aug Jun Jun Jun

19, 19, 19, 27, 27, 27,

2011 2011 2011 2008 2008 2008

N018651 001 N018651 002 N018651 003

May 31, 1985 May 31, 1985 May 31, 1985

DRONEDARONE HYDROCHLORIDE
TABLET; ORAL
MULTAQ
XX + SANOFI AVENTIS US

EQ 400MG BASE

N022425 001

Jul 01, 2009

DROPERIDOL
INJECTABLE; INJECTION DROPERIDOL HOSPIRA AP LUITPOLD AP INAPSINE AP + AKORN INC

2.5MG/ML 2.5MG/ML 2.5MG/ML

A071981 001 A072123 001 N016796 001

Feb 29, 1988 Oct 24, 1988

DROSPIRENONE; ESTRADIOL
TABLET; ORAL
ANGELIQ
XX + BAYER HLTHCARE

0.5MG;1MG

N021355 002

Sep 28, 2005

DROSPIRENONE; ETHINYL ESTRADIOL

TABLET; ORAL DROSPIRENONE AND ETHINYL ESTRADIOL BARR AB 3MG;0.02MG

A078515 001

Mar 30, 2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

DROSPIRENONE; ETHINYL ESTRADIOL
TABLET; ORAL DROSPIRENONE AND ETHINYL ESTRADIOL WATSON LABS AB 3MG;0.02MG LORYNA SANDOZ AB 3MG;0.02MG YAZ AB + BAYER HLTHCARE 3MG;0.02MG TABLET; ORAL-28 DROSPIRENONE AND ETHINYL ESTRADIOL BARR 3MG;0.03MG WATSON LABS 3MG;0.03MG SYEDA SANDOZ 3MG;0.03MG YASMIN + BAYER HLTHCARE 3MG;0.03MG

3 - 152 (of 424)

A078833 001 A079221 001 N021676 001

Nov 28, 2011 Mar 28, 2011 Mar 16, 2006

AB AB AB AB

A077527 001 A090081 001 A090114 001 N021098 001

May 09, 2008 Sep 07, 2010 Mar 28, 2011 May 11, 2001

DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM

TABLET; ORAL
BEYAZ
XX + BAYER HLTHCARE SAFYRAL BAYER HLTHCARE XX

3MG,N/A;0.02MG,N/A;0.451MG,0.451MG 3MG,N/A;0.03MG,N/A;0.451MG,0.451MG

N022532 001 N022574 001

Sep 24, 2010 Dec 16, 2010

DULOXETINE HYDROCHLORIDE
CAPSULE, DELAYED REL PELLETS; ORAL CYMBALTA LILLY EQ 20MG BASE XX EQ 30MG BASE XX EQ 60MG BASE XX +

N021427 001 N021427 002 N021427 004

Aug 03, 2004 Aug 03, 2004 Aug 03, 2004

DUTASTERIDE
CAPSULE; ORAL AVODART AB + GLAXOSMITHKLINE DUTASTERIDE BARR AB

0.5MG 0.5MG

N021319 001 A090095 001

Nov 20, 2001 Dec 21, 2010

DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE

CAPSULE; ORAL
JALYN
XX + GLAXOSMITHKLINE

0.5MG;0.4MG

N022460 001

Jun 14, 2010

DYPHYLLINE
TABLET; ORAL
LUFYLLIN
MEDA PHARMS XX XX +

200MG 400MG

A084566 001
A084566 002

ECHOTHIOPHATE IODIDE
FOR SOLUTION; OPHTHALMIC
PHOSPHOLINE IODIDE
XX + WYETH PHARMS INC

0.125%

N011963 001

ECONAZOLE NITRATE
CREAM; TOPICAL ECONAZOLE NITRATE AB + ALTANA PERRIGO NEW YORK AB

1% 1%

A076075 001 A076479 001

Nov 26, 2002 Jun 23, 2004

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

ECONAZOLE NITRATE
CREAM; TOPICAL ECONAZOLE NITRATE PRASCO AB TARO AB

3 - 153 (of 424)

1% 1%

A076574 001 A076005 001

Dec 17, 2004

Nov 26, 2002

EDETATE CALCIUM DISODIUM

INJECTABLE; INJECTION

CALCIUM DISODIUM VERSENATE

200MG/ML XX + MEDICIS

N008922 001

EDROPHONIUM CHLORIDE
INJECTABLE; INJECTION ENLON BIONICHE PHARMA AP 10MG/ML TENSILON AP + VALEANT PHARM INTL 10MG/ML
TENSILON PRESERVATIVE FREE
AP + VALEANT PHARM INTL 10MG/ML

A088873 001 N007959 001 N007959 002

Aug 06, 1985

EFAVIRENZ
CAPSULE; ORAL
SUSTIVA
BRISTOL MYERS SQUIBB XX XX +

50MG
200MG

N020972 001 N020972 003

Sep 17, 1998 Sep 17, 1998

TABLET; ORAL

SUSTIVA

XX + BRISTOL MYERS SQUIBB 600MG

N021360 002

Feb 01, 2002

EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

TABLET; ORAL

ATRIPLA

XX + GILEAD

600MG;200MG;300MG

N021937 001

Jul 12, 2006

EFLORNITHINE HYDROCHLORIDE
CREAM; TOPICAL

VANIQA

XX + SKINMEDICA

13.9%

N021145 001

Jul 27, 2000

ELETRIPTAN HYDROBROMIDE
TABLET; ORAL
RELPAX
PFIZER IRELAND XX XX +

EQ 20MG BASE
EQ 40MG BASE

N021016 001 N021016 002

Dec 26, 2002 Dec 26, 2002

ELTROMBOPAG OLAMINE
TABLET; ORAL
PROMACTA
GLAXOSMITHKLINE XX XX XX + XX

EQ EQ EQ EQ

12.5MG ACID
25MG ACID
50MG ACID
75MG ACID

N022291 N022291 N022291 N022291

004 001 002 003

Oct Nov Nov Sep

20, 20, 20, 08,

2011 2008 2008 2009

EMEDASTINE DIFUMARATE
SOLUTION/DROPS; OPHTHALMIC
EMADINE
XX + ALCON 0.05%

N020706 001

Dec 29, 1997

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

EMTRICITABINE
CAPSULE; ORAL

EMTRIVA

XX + GILEAD SOLUTION; ORAL

EMTRIVA

XX + GILEAD

3 - 154 (of 424)

200MG

N021500 001

Jul 02, 2003

10MG/ML

N021896 001

Sep 28, 2005

EMTRICITABINE; RILPIVIRINE; TENOFOVIR DISOPROXIL FUMARATE

TABLET; ORAL

COMPLERA
XX + GILEAD SCIENCES INC

200MG;25MG;300MG

N202123 001

Aug 10, 2011

EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

TABLET; ORAL

TRUVADA

XX + GILEAD

200MG;300MG

N021752 001

Aug 02, 2004

ENALAPRIL MALEATE
TABLET; ORAL ENALAPRIL MALEATE APOTEX AB AB AB AB LEK PHARMS AB AB AB AB MYLAN AB AB AB AB AB AB AB AB SANDOZ AB AB AB AB TARO AB AB AB AB TEVA AB AB AB AB WATSON LABS AB AB AB AB WOCKHARDT USA AB AB AB AB VASOTEC VALEANT INTL AB AB

2.5MG 5MG 10MG 20MG 2.5MG 5MG 10MG 20MG 2.5MG 2.5MG 5MG 5MG 10MG 10MG 20MG 20MG 2.5MG 5MG 10MG 20MG 2.5MG 5MG 10MG 20MG 2.5MG 5MG 10MG 20MG 2.5MG 5MG 10MG 20MG 2.5MG 5MG 10MG 20MG 2.5MG 5MG

A075178 A075178 A075178 A075178 A075496 A075496 A075459 A075459 A075472 A075480 A075472 A075480 A075472 A075480 A075472 A075480 A075621 A075621 A075621 A075621 A075657 A075657 A075657 A075657 A075479 A075479 A075479 A075479 A075501 A075501 A075501 A075501 A075483 A075483 A075483 A075483

002 001 003 004 001 002 001 002 001 001 002 002 003 003 004 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004

Mar Mar Mar Mar Aug Aug Aug Aug Aug Aug Aug Aug Aug Aug Aug Aug Aug Aug Aug Aug Jan Jan Jan Jan Aug Aug Aug Aug Aug Aug Aug Aug Aug Aug Aug Aug

23, 23, 23, 23, 22, 22, 22, 22, 22, 22, 22, 22, 22, 22, 22, 22, 22, 22, 22, 22, 23, 23, 23, 23, 22, 22, 22, 22, 22, 22, 22, 22, 22, 22, 22, 22,

2001 2001 2001 2001 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2001 2001 2001 2001 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000

N018998 005 N018998 001

Jul 26, 1988 Dec 24, 1985

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

ENALAPRIL MALEATE
TABLET; ORAL VASOTEC VALEANT INTL AB AB +

3 - 155 (of 424)

10MG 20MG

N018998 002 N018998 003

Dec 24, 1985 Dec 24, 1985

ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE

TABLET; ORAL ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE APOTEX INC 5MG;12.5MG AB 10MG;25MG AB DR REDDYS LABS LTD 5MG;12.5MG AB 10MG;25MG AB MYLAN 5MG;12.5MG AB 10MG;25MG AB SANDOZ 5MG;12.5MG AB 10MG;25MG AB TARO PHARM INDS 5MG;12.5MG AB 10MG;25MG AB TEVA 5MG;12.5MG AB 10MG;25MG AB VASERETIC VALEANT INTL AB 5MG;12.5MG AB + 10MG;25MG

A076486 A076486 A075909 A075909 A075624 A075624 A076116 A076116 A075788 A075788 A075727 A075727

001 002 001 002 001 002 001 002 001 002 001 002

Oct Oct Oct Oct Sep Sep Sep Sep Sep Sep Sep Sep

27, 27, 15, 15, 18, 18, 19, 19, 18, 18, 18, 18,

2004 2004 2001 2001 2001 2001 2001 2001 2001 2001 2001 2001

N019221 003 N019221 001

Jul 12, 1995 Oct 31, 1986

ENALAPRILAT
INJECTABLE; INJECTION ENALAPRILAT + BEDFORD HIKMA FARMACEUTICA + HOSPIRA TEVA PARENTERAL

AP AP AP AP

1.25MG/ML 1.25MG/ML 1.25MG/ML 1.25MG/ML

A075634 A078687 A075458 A075578

001 001 001 001

Aug Dec Aug Aug

22, 23, 22, 22,

2000 2008 2000 2000

ENFLURANE
LIQUID; INHALATION ENFLURANE PIRAMAL CRITICAL AN ETHRANE AN + BAXTER HLTHCARE CORP

99.9% 99.9%

A074396 001 N017087 001

Jul 29, 1994

ENFUVIRTIDE
INJECTABLE; SUBCUTANEOUS
FUZEON
XX + ROCHE

90MG/VIAL

N021481 001

Mar 13, 2003

ENOXAPARIN SODIUM
INJECTABLE; INTRAVENOUS, SUBCUTANEOUS ENOXAPARIN SODIUM SANDOZ INC AB 300MG/3ML (100MG/ML) LOVENOX SANOFI AVENTIS US AB 300MG/3ML (100MG/ML) INJECTABLE; SUBCUTANEOUS ENOXAPARIN SODIUM (PRESERVATIVE FREE) AMPHASTAR PHARM 30MG/0.3ML (100MG/ML) 40MG/0.4ML (100MG/ML) 60MG/0.6ML (100MG/ML) 80MG/0.8ML (100MG/ML) 100MG/ML (100MG/ML) 120MG/0.8ML (150MG/ML)

A078660 001 N020164 009

Nov 28, 2011 Jan 23, 2003

AP AP AP AP AP AP

A076684 A076684 A076684 A076684 A076684 A076684

001 002 003 004 005 006

Sep Sep Sep Sep Sep Sep

19, 19, 19, 19, 19, 19,

2011 2011 2011 2011 2011 2011

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

ENOXAPARIN SODIUM
INJECTABLE; SUBCUTANEOUS ENOXAPARIN SODIUM (PRESERVATIVE FREE) AMPHASTAR PHARM 150MG/ML (150MG/ML) SANDOZ 30MG/0.3ML (100MG/ML) 40MG/0.4ML (100MG/ML) 60MG/0.6ML (100MG/ML) 80MG/0.8ML (100MG/ML) 100MG/ML (100MG/ML) 120MG/0.8ML (150MG/ML) 150MG/ML (150MG/ML) LOVENOX (PRESERVATIVE FREE) SANOFI AVENTIS US 30MG/0.3ML (100MG/ML) 40MG/0.4ML (100MG/ML) 60MG/0.6ML (100MG/ML) 80MG/0.8ML (100MG/ML) + 100MG/ML (100MG/ML) 120MG/0.8ML (150MG/ML) 150MG/ML (150MG/ML)

3 - 156 (of 424)

AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP

A076684 A077857 A077857 A077857 A077857 A077857 A077857 A077857 N020164 N020164 N020164 N020164 N020164 N020164 N020164

007 002 003 004 005 001 006 007 001 002 003 004 005 007 008

Sep Jul Jul Jul Jul Jul Jul Jul Mar Jan Mar Mar Mar Jun Jun

19, 23, 23, 23, 23, 23, 23, 23, 29, 30, 27, 27, 27, 02, 02,

2011 2010 2010 2010 2010 2010 2010 2010 1993 1998 1998 1998 1998 2000 2000

ENTACAPONE
TABLET; ORAL

COMTAN

XX + ORION

200MG

N020796 001

Oct 19, 1999

ENTECAVIR

SOLUTION; ORAL

BARACLUDE
XX + BRISTOL MYERS SQUIBB TABLET; ORAL BARACLUDE BRISTOL MYERS SQUIBB XX XX +

0.05MG/ML

N021798 001

Mar 29, 2005

0.5MG 1MG

N021797 001 N021797 002

Mar 29, 2005 Mar 29, 2005

EPINASTINE HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC ELESTAT + ALLERGAN 0.05% EPINASTINE HYDROCHLORIDE APOTEX 0.05% CYPRESS PHARM 0.05% PHARMAFORCE 0.05% SUN PHARM INDS 0.05%

AT AT AT AT AT

N021565 001 A090919 A090870 A090951 A091626 001 001 001 001

Oct 16, 2003 Oct Mar Oct Oct 31, 14, 31, 31, 2011 2011 2011 2011

EPINEPHRINE
INJECTABLE; IM-SC ADRENACLICK + SHIONOGI INC + TWINJECT 0.15 + SHIONOGI INC TWINJECT 0.3 + SHIONOGI INC

BX BX BX BX

EQ 0.15MG /DELIVERY EQ 0.3MG /DELIVERY EQ 0.15MG /DELIVERY EQ 0.3MG /DELIVERY

N020800 003 N020800 004 N020800 002 N020800 001

Nov 25, 2009 Nov 25, 2009 May 28, 2004 May 30, 2003

INJECTABLE; INTRAMUSCULAR EPIPEN BX + MERIDIAN MEDCL TECHN 0.3MG/DELIVERY EPIPEN JR. BX + MERIDIAN MEDCL TECHN 0.15MG/DELIVERY

N019430 001 N019430 002

Dec 22, 1987 Dec 22, 1987

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE
INJECTABLE; INJECTION

LIGNOSPAN FORTE

XX + DEPROCO LIGNOSPAN STANDARD XX + DEPROCO

3 - 157 (of 424)

EQ 0.02MG BASE/ML;2% EQ 0.01MG BASE/ML;2%

A088389 001 A088390 001

Jan 22, 1985 Jan 22, 1985

EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE

INJECTABLE; INJECTION CITANEST FORTE DENTAL AP + DENTSPLY PHARM 0.005MG/ML;4% PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE SEPTODONT INC AP 0.005MG/ML;4%

N021383 001 A078959 001 Aug 30, 2011

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

INJECTABLE; INJECTION LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE EASTMAN KODAK 0.01MG/ML;2% AP 0.02MG/ML;2% AP HOSPIRA 0.005MG/ML;0.5% AP 0.005MG/ML;1.5% AP 0.005MG/ML;1.5% AP 0.005MG/ML;2% AP 0.01MG/ML;1% AP 0.01MG/ML;2% AP 0.01MG/ML;2% AP 0.02MG/ML;2% AP OCTOCAINE SEPTODONT AP 0.01MG/ML;2% AP + 0.02MG/ML;2% XYLOCAINE DENTAL WITH EPINEPHRINE 0.01MG/ML;2% AP + DENTSPLY PHARM 0.02MG/ML;2% AP + XYLOCAINE W/ EPINEPHRINE 0.005MG/ML;0.5% AP + APP PHARMS 0.005MG/ML;1% AP + 0.005MG/ML;1.5% AP + 0.005MG/ML;2% AP + 0.01MG/ML;1% AP + 0.02MG/ML;2% AP +

A040057 A040057 A089635 A088571 A089645 A089651 A089644 A078772 A089646 A078772

002 001 001 001 001 001 001 001 001 002

Feb Feb Jun Sep Jun Jun Jun May Jun May

26, 26, 21, 13, 21, 21, 21, 12, 21, 12,

1993 1993 1988 1985 1988 1988 1988 2008 1988 2008

A084048 001 A084048 002 N021381 001 N021381 002 N006488 N006488 N006488 N006488 N006488 N006488 012 018 017 019 004 005

Nov 13, 1986 Nov 13, 1986

EPIRUBICIN HYDROCHLORIDE
INJECTABLE; INJECTION ELLENCE AP + PFIZER INC 200MG/100ML (2MG/ML) AP 50MG/25ML (2MG/ML) EPIRUBICIN HYDROCHLORIDE ACTAVIS TOTOWA 10MG/5ML (2MG/ML) AP 50MG/25ML (2MG/ML) AP 200MG/100ML (2MG/ML) AP AKORN INC 50MG/25ML (2MG/ML) AP APP PHARMS 10MG/5ML (2MG/ML) AP 150MG/75ML (2MG/ML) AP 200MG/100ML (2MG/ML) AP 50MG/25ML (2MG/ML) AP BEDFORD 200MG/100ML (2MG/ML) AP 50MG/25ML (2MG/ML) AP BIONICHE PHARMA USA 50MG/25ML (2MG/ML) AP 200MG/100ML (2MG/ML) AP EBEWE PHARMA 50MG/25ML (2MG/ML) AP

N050778 001 N050778 002 A065445 A065445 A065445 A090163 A065408 A065408 A065408 A065408 A065289 A065289 A065371 A065371 A065339 001 002 003 001 001 003 004 002 002 001 001 002 001

Sep 15, 1999 Sep 15, 1999 Sep Sep Sep Jun Oct Oct Oct Oct Jun Jun Nov Nov Dec 18, 18, 18, 24, 15, 15, 15, 15, 27, 27, 28, 28, 22, 2008 2008 2008 2009 2007 2007 2007 2007 2007 2007 2007 2007 2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

EPIRUBICIN HYDROCHLORIDE
INJECTABLE; INJECTION EPIRUBICIN HYDROCHLORIDE EBEWE PHARMA 200MG/100ML (2MG/ML) FRESENIUS KABI ONCOL 200MG/100ML (2MG/ML) 50MG/25ML (2MG/ML) HOSPIRA 200MG/100ML (2MG/ML) 50MG/25ML (2MG/ML) 10MG/5ML (2MG/ML) 150MG/75ML (2MG/ML) MUSTAFA NEVSAT 200MG/100ML (2MG/ML) 50MG/25ML (2MG/ML) TEVA PARENTERAL 50MG/25ML (2MG/ML) 200MG/100ML (2MG/ML) WATSON LABS 200MG/100ML (2MG/ML) 50MG/25ML (2MG/ML) X GEN PHARMS 50MG/25ML (2MG/ML) 200MG/100ML (2MG/ML)

3 - 158 (of 424)

AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP

A065339 A065411 A065411 A065343 A065343 A065343 A065343 A090266 A090266 A065331 A065331 A065361 A065361 A090075 A090075

002 001 002 004 002 001 003 002 001 001 002 002 001 001 002

Dec Aug Aug Apr Apr Apr Apr Apr Apr Aug Aug Oct Oct Mar Mar

22, 20, 20, 19, 19, 19, 19, 15, 15, 09, 09, 22, 22, 25, 25,

2009 2007 2007 2007 2007 2007 2007 2011 2011 2007 2007 2007 2007 2010 2010

INJECTABLE; IV (INFUSION)
EPIRUBICIN HYDROCHLORIDE
50MG/VIAL XX + HOSPIRA

N050807 001

Sep 15, 2006

EPLERENONE
TABLET; ORAL EPLERENONE APOTEX AB AB SANDOZ AB AB INSPRA GD SEARLE LLC AB AB +

25MG 50MG 25MG 50MG 25MG 50MG

A078482 A078482 A078510 A078510

001 002 001 002

Jul Jul Aug Aug

30, 30, 01, 01,

2008 2008 2008 2008

N021437 001 N021437 002

Sep 27, 2002 Sep 27, 2002

EPOPROSTENOL SODIUM
INJECTABLE; INJECTION EPOPROSTENOL SODIUM TEVA PARENTERAL AP AP FLOLAN AP + GLAXOSMITHKLINE LLC AP + VELETRI XX + ACTELION

EQ 0.5MG BASE/VIAL EQ 1.5MG BASE/VIAL EQ 0.5MG BASE/VIAL EQ 1.5MG BASE/VIAL EQ 1.5MG BASE/VIAL

A078396 001 A078396 002 N020444 001 N020444 002 N022260 001

Apr 23, 2008 Apr 23, 2008 Sep 20, 1995 Sep 20, 1995 Jun 27, 2008

EPROSARTAN MESYLATE
TABLET; ORAL EPROSARTAN MESYLATE MYLAN PHARMS INC AB AB TEVETEN ABBOTT AB AB +

EQ 400MG BASE EQ 600MG BASE EQ 400MG BASE EQ 600MG BASE

A202012 001 A202012 002 N020738 005 N020738 006

Nov 16, 2011 Nov 16, 2011 Dec 22, 1997 May 27, 1999

EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE

TABLET; ORAL TEVETEN HCT ABBOTT XX XX +

600MG;12.5MG 600MG;25MG

N021268 001 N021268 002

Nov 01, 2001 Nov 01, 2001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

EPTIFIBATIDE
INJECTABLE; INJECTION

INTEGRILIN

XX + SCHERING XX +

3 - 159 (of 424)

2MG/ML 75MG/100ML

N020718 001 N020718 002

May 18, 1998 May 18, 1998

ERGOCALCIFEROL
CAPSULE; ORAL DRISDOL + SANOFI AVENTIS US ERGOCALCIFEROL ORIT LABS LLC SIGMAPHARM LABS LLC STRIDES ARCOLAB LTD SUN PHARM INDS INC VITAMIN D BANNER PHARMACAPS

AA AA AA AA AA AA

50,000 IU 50,000 50,000 50,000 50,000 IU IU IU IU

N003444 001 A040833 A091004 A090455 A040865 001 001 001 001 May Jul Aug Dec 20, 14, 03, 29, 2009 2010 2010 2009

50,000 IU

A080704 001

ERGOLOID MESYLATES
TABLET; ORAL ERGOLOID MESYLATES MUTUAL PHARM AB HYDERGINE AB + NOVARTIS
TABLET; SUBLINGUAL

ERGOLOID MESYLATES
WATSON LABS XX

1MG 1MG

A081113 001 N017993 001

Oct 31, 1991

0.5MG

A087233 001

ERGOTAMINE TARTRATE

TABLET; SUBLINGUAL

ERGOMAR
XX + ROSEDALE THERAPEUTIC

2MG

A087693 001

Feb 24, 1983

ERIBULIN MESYLATE
SOLUTION; INTRAVENOUS

HALAVEN

XX + EISAI INC

1MG/2ML (0.5MG/ML)

N201532 001

Nov 15, 2010

ERLOTINIB HYDROCHLORIDE
TABLET; ORAL TARCEVA OSI PHARMS XX XX XX +

EQ 25MG BASE EQ 100MG BASE EQ 150MG BASE

N021743 001 N021743 002 N021743 003

Nov 18, 2004 Nov 18, 2004 Nov 18, 2004

ERTAPENEM SODIUM
INJECTABLE; INTRAMUSCULAR, IV (INFUSION)
INVANZ
XX + MERCK EQ 1GM BASE/VIAL

N021337 001

Nov 21, 2001

ERYTHROMYCIN
CAPSULE, DELAYED REL PELLETS; ORAL ERYC AB + HOSPIRA 250MG WARNER CHILCOTT AB 250MG ERYTHROMYCIN ARBOR PHARMS INC AB 250MG

N050536 001 A062338 001 A062746 001 Dec 22, 1986

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

ERYTHROMYCIN
GEL; TOPICAL E-GLADES COREPHARMA ERYGEL + MERZ PHARMS ERYTHROMYCIN ALTANA PERRIGO

3 - 160 (of 424)

AT AT AT AT

2% 2% 2% 2%

A065009 001 N050617 001 A064184 001 A063211 001

Mar 18, 2002 Oct 21, 1987 Sep 30, 1997 Jan 29, 1993

OINTMENT; OPHTHALMIC ERYTHROMYCIN AKORN AT BAUSCH AND LOMB AT AT + FERA PHARMS

OINTMENT; TOPICAL

AKNE-MYCIN
XX + DOW PHARM SCIENCES SOLUTION; TOPICAL ERYTHRA-DERM PADDOCK LLC ERYTHROMYCIN + FOUGERA PHARMS PERRIGO NEW YORK WOCKHARDT ERYTHRO-STATIN HI TECH PHARMA

0.5% 0.5% 0.5%

A064030 001 A064067 001 A062447 001

Jul 18, 1996 Jul 29, 1994 Sep 26, 1983

2%

N050584 001

Jan 10, 1985

AT AT AT AT AT

2% 2% 2% 2% 2%

A062687 001 A064187 001 A063038 001 A062825 001 A064101 001

Feb 05, 1988 Sep 30, 1997 Jan 11, 1991 Oct 23, 1987 Oct 22, 1996

SWAB; TOPICAL ERYTHROMYCIN AT + ALTANA AT + PERRIGO VERSAPHARM AT

TABLET; ORAL

ERYTHROMYCIN
ARBOR PHARMS INC XX XX +

2% 2% 2%

A065320 001 A064126 001 A090215 001

Jul 25, 2006 Jul 03, 1996 May 12, 2010

250MG 500MG

A061621 001
A061621 002

TABLET, COATED PARTICLES; ORAL PCE ARBOR PHARMS INC 333MG XX 500MG XX +
TABLET, DELAYED RELEASE; ORAL

ERY-TAB
250MG XX + ARBOR PHARMS INC 333MG XX + 500MG XX +

N050611 001 N050611 002

Sep 09, 1986 Aug 22, 1990

A062298 001 A062298 003 A062298 002

Mar 29, 1982

ERYTHROMYCIN ETHYLSUCCINATE
GRANULE; ORAL E.E.S. ARBOR PHARMS INC AB ERYPED ARBOR PHARMS INC AB ERYPED XX + ARBOR PHARMS INC SUSPENSION; ORAL E.E.S. 200 ARBOR PHARMS INC AB E.E.S. 400 AB + ARBOR PHARMS INC

EQ 200MG BASE/5ML EQ 200MG BASE/5ML EQ 400MG BASE/5ML

N050207 001 N050207 003 N050207 002 Mar 30, 1987

EQ 200MG BASE/5ML EQ 400MG BASE/5ML

A061639 001 A061639 002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

ERYTHROMYCIN ETHYLSUCCINATE
SUSPENSION; ORAL PEDIAMYCIN ARBOR PHARMS INC AB PEDIAMYCIN 400 ARBOR PHARMS INC AB

3 - 161 (of 424)

EQ 200MG BASE/5ML EQ 400MG BASE/5ML

A062304 001 A062304 002

TABLET; ORAL E.E.S. 400 BX + ARBOR PHARMS INC EQ 400MG BASE ERYTHROMYCIN ETHYLSUCCINATE BX + ARBOR PHARMS INC EQ 400MG BASE

A061905 002 A061904 001

Aug 12, 1982

ERYTHROMYCIN ETHYLSUCCINATE; SULFISOXAZOLE ACETYL

GRANULE; ORAL

ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL

EQ 200MG BASE/5ML;EQ 600MG BASE/5ML XX + BARR

A062759 001

May 20, 1988

ERYTHROMYCIN LACTOBIONATE
INJECTABLE; INJECTION ERYTHROCIN HOSPIRA AP AP + AP +

EQ 500MG BASE/VIAL EQ 500MG BASE/VIAL EQ 1GM BASE/VIAL

A062638 001 N050609 001 A062638 002

Oct 31, 1986 Sep 24, 1986 Oct 31, 1986

ERYTHROMYCIN STEARATE
TABLET; ORAL

ERYTHROCIN STEARATE

XX + ARBOR PHARMS INC

EQ 250MG BASE

A060359 001

ESCITALOPRAM OXALATE
SOLUTION; ORAL

LEXAPRO

XX + FOREST LABS TABLET; ORAL LEXAPRO FOREST LABS XX XX XX +

EQ 5MG BASE/5ML

N021365 001

Nov 27, 2002

EQ 5MG BASE EQ 10MG BASE EQ 20MG BASE

N021323 001 N021323 002 N021323 003

Aug 14, 2002 Aug 14, 2002 Aug 14, 2002

ESMOLOL HYDROCHLORIDE
INJECTABLE; INJECTION BREVIBLOC + BAXTER HLTHCARE CORP 10MG/ML ESMOLOL HYDROCHLORIDE APP PHARMS 10MG/ML BEDFORD LABS 10MG/ML BIONICHE PHARMA 10MG/ML BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER + BAXTER HLTHCARE CORP 2GM/100ML BREVIBLOC IN PLASTIC CONTAINER + BAXTER HLTHCARE CORP 1GM/100ML

AP AP AP AP XX XX

N019386 006 A076573 001 A076323 001 A076474 001 N019386 005 N019386 004

Feb 25, 2003 May 02, 2005 Aug 10, 2004 May 02, 2005 Jan 27, 2003 Feb 16, 2001

ESOMEPRAZOLE MAGNESIUM
CAPSULE, DELAYED REL PELLETS; ORAL NEXIUM ASTRAZENECA EQ 20MG BASE XX EQ 40MG BASE XX +

N021153 001 N021153 002

Feb 20, 2001 Feb 20, 2001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

ESOMEPRAZOLE MAGNESIUM
FOR SUSPENSION, DELAYED RELEASE; ORAL NEXIUM ASTRAZENECA EQ 10MG BASE/PACKET XX EQ 20MG BASE/PACKET XX EQ 40MG BASE/PACKET XX +

3 - 162 (of 424)

N022101 001 N021957 001 N021957 002

Feb 27, 2008 Oct 20, 2006 Oct 20, 2006

ESOMEPRAZOLE MAGNESIUM; NAPROXEN

TABLET, DELAYED RELEASE; ORAL VIMOVO ASTRAZENECA LP EQ 20MG BASE;375MG XX EQ 20MG BASE;500MG XX +

N022511 002 N022511 001

Apr 30, 2010 Apr 30, 2010

ESOMEPRAZOLE SODIUM
INJECTABLE; INTRAVENOUS

NEXIUM IV

XX + ASTRAZENECA XX +

EQ 20MG BASE/VIAL EQ 40MG BASE/VIAL

N021689 001 N021689 002

Mar 31, 2005 Mar 31, 2005

ESTAZOLAM
TABLET; ORAL ESTAZOLAM PAR PHARM AB AB TEVA AB AB + WATSON LABS AB AB

1MG 2MG 1MG 2MG 1MG 2MG

A074826 A074826 A074921 A074921 A074818 A074818

001 002 001 002 001 002

Jul Jul Jul Jul Aug Aug

03, 03, 10, 10, 19, 19,

1997 1997 1997 1997 1997 1997

ESTRADIOL
CREAM; VAGINAL

ESTRACE

XX + WARNER CHILCOTT

0.01%

A086069 001

Jan 31, 1984

FILM, EXTENDED RELEASE; TRANSDERMAL CLIMARA BAYER HLTHCARE AB 0.0375MG/24HR AB 0.06MG/24HR ESTRADIOL MYLAN TECHNOLOGIES AB 0.0375MG/24HR AB 0.06MG/24HR VIVELLE NOVARTIS AB1 0.05MG/24HR AB1 0.1MG/24HR VIVELLE-DOT NOVARTIS AB1 0.05MG/24HR AB1 + 0.1MG/24HR CLIMARA BAYER HLTHCARE AB2 0.025MG/24HR AB2 0.05MG/24HR AB2 0.075MG/24HR AB2 + 0.1MG/24HR ESTRADIOL MYLAN TECHNOLOGIES AB2 0.025MG/24HR AB2 0.05MG/24HR AB2 0.075MG/24HR AB2 0.1MG/24HR ALORA BX WATSON LABS 0.025MG/24HR BX 0.05MG/24HR BX 0.075MG/24HR

N020375 005 N020375 006 A075182 004 A075182 005 N020323 002 N020323 004 N020538 006 N020538 008 N020375 N020375 N020375 N020375 A075182 A075182 A075182 A075182 004 001 003 002 003 006 002 001

May 27, 2003 May 27, 2003 Jul 20, 2006 Jul 20, 2006 Oct 28, 1994 Oct 28, 1994 Jan 08, 1999 Jan 08, 1999 Mar Dec Mar Dec Jan Feb Jan Feb 05, 22, 23, 22, 26, 24, 26, 24, 1999 1994 1998 1994 2005 2000 2005 2000

N020655 004 N020655 001 N020655 002

Apr 05, 2002 Dec 20, 1996 Dec 20, 1996

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

ESTRADIOL
FILM, EXTENDED RELEASE; TRANSDERMAL ALORA WATSON LABS 0.1MG/24HR ESTRADERM NOVARTIS 0.05MG/24HR + 0.1MG/24HR VIVELLE-DOT NOVARTIS 0.025MG/24HR 0.0375MG/24HR 0.075MG/24HR MENOSTAR + BAYER HLTHCARE 0.014MG/24HR

3 - 163 (of 424)

BX BX BX BX BX BX XX

N020655 003 N019081 002 N019081 003 N020538 009 N020538 005 N020538 007 N021674 001

Dec 20, 1996 Sep 10, 1986 Sep 10, 1986 May 03, 2002 Jan 08, 1999 Jan 08, 1999 Jun 08, 2004

GEL; TRANSDERMAL DIVIGEL UPSHER SMITH XX XX XX +

0.1% (0.5GM/PACKET) 0.1% (0.25GM/PACKET) 0.1% (1GM/PACKET)

N022038 002 N022038 001 N022038 003

Jun 04, 2007 Jun 04, 2007 Jun 04, 2007

GEL, METERED; TRANSDERMAL

ELESTRIN
0.06% (0.87GM/ACTIVATION) XX + AZUR PHARMA II ESTROGEL 0.06% (1.25GM/ACTIVATION) XX + ASCEND
INSERT, EXTENDED RELEASE; VAGINAL

ESTRING
XX + PHARMACIA AND UPJOHN 0.0075MG/24HR
SPRAY; TRANSDERMAL

EVAMIST
XX + KV PHARM TABLET; ORAL ESTRACE BRISTOL MYERS SQUIBB AB AB + ESTRADIOL BARR AB AB AB MYLAN AB AB AB USL PHARMA AB AB AB WATSON LABS AB AB AB
TABLET; VAGINAL

VAGIFEM
XX + NOVO NORDISK INC

N021813 001 N021166 002

Dec 15, 2006 Feb 09, 2004

N020472 001

Apr 26, 1996

1.53MG/SPRAY

N022014 001

Jul 27, 2007

1MG 2MG 0.5MG 1MG 2MG 0.5MG 1MG 2MG 0.5MG 1MG 2MG 0.5MG 1MG 2MG

A084499 001 A084500 001 A040197 A040197 A040197 A040326 A040326 A040326 A040297 A040297 A040297 A040114 A040114 A040114 001 002 003 001 002 003 001 002 003 003 001 002 Oct Oct Oct Apr Apr Apr Apr Apr Apr Mar Mar Mar 22, 22, 22, 21, 21, 21, 17, 17, 17, 14, 14, 14, 1997 1997 1997 1999 1999 1999 2002 2002 2002 1996 1996 1996

10MCG

N020908 002

Nov 25, 2009

ESTRADIOL ACETATE
INSERT, EXTENDED RELEASE; VAGINAL FEMRING GALEN LTD EQ 0.05MG BASE/24HR XX EQ 0.1MG BASE/24HR XX + TABLET; ORAL FEMTRACE WARNER CHILCOTT XX XX

N021367 001 N021367 002

Mar 20, 2003 Mar 20, 2003

0.45MG 0.9MG

N021633 001 N021633 002

Aug 20, 2004 Aug 20, 2004

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

ESTRADIOL ACETATE
TABLET; ORAL
FEMTRACE
XX + WARNER CHILCOTT

3 - 164 (of 424)

1.8MG

N021633 003

Aug 20, 2004

ESTRADIOL CYPIONATE
INJECTABLE; INJECTION DEPO-ESTRADIOL AO + PHARMACIA AND UPJOHN ESTRADIOL CYPIONATE WATSON LABS AO

5MG/ML 5MG/ML

A085470 003 A085620 001

ESTRADIOL HEMIHYDRATE
EMULSION; TOPICAL
ESTRASORB
XX + MEDICIS

0.25%

N021371 001

Oct 09, 2003

ESTRADIOL VALERATE
INJECTABLE; INJECTION DELESTROGEN + JHP PHARMS + + ESTRADIOL VALERATE LUITPOLD SANDOZ

AO AO AO AO AO AO AO AO AO AO

10MG/ML 20MG/ML 40MG/ML 20MG/ML 40MG/ML 10MG/ML 20MG/ML 40MG/ML 20MG/ML 40MG/ML

N009402 002 N009402 004 N009402 003 A090920 A090920 A040628 A040628 A040628 A083547 A083714 001 002 001 002 003 001 001 Jan Jan Oct Oct Oct 19, 19, 04, 04, 04, 2010 2010 2007 2007 2007

WATSON LABS

ESTRADIOL; LEVONORGESTREL
FILM, EXTENDED RELEASE; TRANSDERMAL
CLIMARA PRO
0.045MG/24HR;0.015MG/24HR XX + BAYER HLTHCARE

N021258 001

Nov 21, 2003

ESTRADIOL; NORETHINDRONE ACETATE

FILM, EXTENDED RELEASE; TRANSDERMAL COMBIPATCH NOVARTIS 0.05MG/24HR;0.14MG/24HR XX 0.05MG/24HR;0.25MG/24HR XX + TABLET; ORAL ACTIVELLA NOVO NORDISK INC 0.5MG;0.1MG + 1MG;0.5MG ESTRADIOL AND NORETHINDRONE ACETATE BARR 1MG;0.5MG BRECKENRIDGE PHARM 0.5MG;0.1MG 1MG;0.5MG

N020870 001 N020870 002

Aug 07, 1998 Aug 07, 1998

AB AB AB AB AB

N020907 002 N020907 001 A079193 001 A078324 002 A078324 001

Dec 28, 2006 Nov 18, 1998 May 11, 2010 Jun 09, 2011 Apr 17, 2008

ESTRADIOL; NORGESTIMATE
TABLET; ORAL ESTRADIOL AND NORGESTIMATE BARR AB 1MG,1MG;N/A,0.09MG PREFEST AB + TEVA WOMENS 1MG,1MG;N/A,0.09MG

A076812 001 N021040 001

Apr 29, 2005 Oct 22, 1999

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

ESTRAMUSTINE PHOSPHATE SODIUM

CAPSULE; ORAL

EMCYT
XX + PHARMACIA AND UPJOHN

3 - 165 (of 424)

EQ 140MG PHOSPHATE

N018045 001

ESTROGENS, CONJUGATED

CREAM; TOPICAL, VAGINAL

PREMARIN
XX + WYETH PHARMS INC
INJECTABLE; INJECTION

PREMARIN
XX + WYETH PHARMS INC TABLET; ORAL PREMARIN WYETH PHARMS INC XX XX XX + XX + XX +

0.625MG/GM

N020216 001

25MG/VIAL

N010402 001

0.3MG 0.45MG 0.625MG 0.9MG 1.25MG

N004782 N004782 N004782 N004782 N004782

003 006 004 005 001

Jul 16, 2003 Jan 26, 1984

ESTROGENS, CONJUGATED SYNTHETIC A

CREAM; VAGINAL

SYNTHETIC CONJUGATED ESTROGENS A
XX + TEVA WOMENS 0.625MG/GM TABLET; ORAL CENESTIN XX TEVA WOMENS XX XX XX XX +

N021788 001

Nov 28, 2008

0.3MG 0.45MG 0.625MG 0.9MG 1.25MG

N020992 N020992 N020992 N020992 N020992

001 005 002 003 004

Jun Feb Mar Mar Mar

21, 05, 24, 24, 13,

2002 2004 1999 1999 2000

ESTROGENS, CONJUGATED SYNTHETIC B

TABLET; ORAL ENJUVIA TEVA WOMENS XX XX XX XX XX +

0.3MG 0.45MG 0.625MG 0.9MG 1.25MG

N021443 N021443 N021443 N021443 N021443

001 002 003 005 004

Dec Dec May Apr May

20, 20, 10, 27, 10,

2004 2004 2004 2007 2004

ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE

TABLET; ORAL-28

PREMPHASE 14/14

+ WYETH PHARMS INC PREMPRO + WYETH PHARMS INC + + +

XX XX XX XX XX

0.625MG,0.625MG;N/A,5MG 0.3MG;1.5MG 0.45MG;1.5MG 0.625MG;2.5MG 0.625MG;5MG

N020527 002 N020527 N020527 N020527 N020527 005 004 001 003

Nov 17, 1995 Jun Mar Nov Jan 04, 12, 17, 09, 2003 2003 1995 1998

ESTROGENS, ESTERIFIED
TABLET; ORAL

MENEST

MONARCH PHARMS XX XX XX XX +

0.3MG 0.625MG 1.25MG 2.5MG

A084951 A084948 A084950 A084949

001

001

001

001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

ESTRONE
INJECTABLE; INJECTION
ESTRONE
XX + WATSON LABS

3 - 166 (of 424)

5MG/ML

A085239 001

ESTROPIPATE
TABLET; ORAL ESTROPIPATE BARR AB AB AB MYLAN AB AB WATSON LABS AB AB AB AB OGEN .625 PHARMACIA AND UPJOHN AB OGEN 1.25 PHARMACIA AND UPJOHN AB OGEN 2.5 AB + PHARMACIA AND UPJOHN OGEN 5 PHARMACIA AND UPJOHN AB ORTHO-EST SUN PHARM INDS (IN) AB AB

0.75MG 1.5MG 3MG 0.75MG 1.5MG 0.75MG 1.5MG 3MG 6MG 0.75MG 1.5MG 3MG 6MG 0.75MG 1.5MG

A040135 A040135 A040135 A040359 A040359 A081213 A081214 A081215 A081216

001 002 003 001 002 001 001 001 001

Nov Nov Nov Aug Aug Sep Sep Sep Sep

27, 27, 27, 26, 26, 23, 23, 23, 23,

1996 1996 1996 1999 1999 1993 1993 1993 1993

A083220 001 A083220 002 A083220 003 A083220 004 A089567 001 A089582 001 Feb 27, 1991 Jul 17, 1991

ESZOPICLONE
TABLET; ORAL LUNESTA SUNOVION PHARMS INC XX XX XX +

1MG 2MG 3MG

N021476 001 N021476 002 N021476 003

Dec 15, 2004 Dec 15, 2004 Dec 15, 2004

ETHACRYNATE SODIUM
INJECTABLE; INJECTION
EDECRIN
XX + ATON

EQ 50MG BASE/VIAL

N016093 001

ETHACRYNIC ACID
TABLET; ORAL
EDECRIN
XX + ATON

25MG

N016092 001

ETHAMBUTOL HYDROCHLORIDE
TABLET; ORAL ETHAMBUTOL HYDROCHLORIDE BARR AB 400MG LUPIN AB 100MG AB 400MG WEST WARD AB 100MG AB + 400MG MYAMBUTOL STI PHARMA LLC AB 100MG AB 400MG

A076057 A078939 A078939 A075095 A075095

001 001 002 001 002

Nov Jun Jun Nov Nov

26, 17, 17, 30, 30,

2001 2009 2009 1999 1999

N016320 001 N016320 003

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

ETHANOLAMINE OLEATE
INJECTABLE; INJECTION ETHAMOLIN XX + QOL MEDCL

3 - 167 (of 424)

50MG/ML

N019357 001

Dec 22, 1988

ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE

TABLET; ORAL-28 KELNOR BARR AB ZOVIA 1/35E-28 WATSON LABS AB ZOVIA 1/50E-28 XX + WATSON LABS

0.035MG;1MG 0.035MG;1MG 0.05MG;1MG

A076785 001 A072721 001 A072723 001

May 23, 2005 Dec 30, 1991 Dec 30, 1991

ETHINYL ESTRADIOL; ETONOGESTREL

RING; VAGINAL NUVARING XX + ORGANON USA INC

0.015MG;0.12MG

N021187 001

Oct 03, 2001

ETHINYL ESTRADIOL; LEVONORGESTREL

TABLET; ORAL INTROVALE SANDOZ AB 0.03MG;0.15MG LEVONORGESTREL AND ETHINYL ESTRADIOL LUPIN LTD AB 0.02MG,0.01MG;0.1MG,N/A VINTAGE PHARMS AB 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.1 25MG WATSON LABS AB 0.02MG;0.09MG AB 0.02MG,0.01MG;0.1MG,N/A LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL WATSON LABS AB 0.03MG,0.01MG;0.15MG,N/A LOSEASONIQUE TEVA WOMENS AB 0.02MG,0.01MG;0.1MG,N/A LYBREL AB + WYETH PHARMS INC 0.02MG;0.09MG QUASENSE WATSON LABS AB 0.03MG;0.15MG SEASONALE AB + DURAMED RES 0.03MG;0.15MG SEASONIQUE AB + TEVA WOMENS 0.03MG,0.01MG;0.15MG,N/A TABLET; ORAL-28 ALTAVERA SANDOZ AB ENPRESSE-28 DURAMED PHARMS BARR AB LEVONEST NOVAST LABS LTD LEVORA 0.15/30-28 WATSON LABS NORDETTE-28 + DURAMED PORTIA-28 BARR TRIVORA-28 + WATSON LABS AVIANE-28 DURAMED PHARMS BARR

A079064 001 A091674 001 A077502 001 A079218 001 A200407 001 A078834 001 N022262 001 N021864 001 A077101 001 N021544 001 N021840 001

Sep 27, 2010 Oct 26, 2011 Nov 23, 2011 Jun 06, 2011 Oct 25, 2011 May 31, 2011 Oct 24, 2008 May 22, 2007 Sep 06, 2006 Sep 05, 2003 May 25, 2006

0.03MG;0.15MG 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.1 25MG 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.1 25MG 0.03MG;0.15MG 0.03MG;0.15MG 0.03MG;0.15MG 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.1 25MG 0.02MG;0.1MG

A079102 001 A075809 002

Aug 03, 2010 Jul 16, 2001

AB

A090719 001

Dec 29, 2010

AB AB AB AB

A073594 001 N018782 001 A075866 002 A074538 002

Dec 13, 1993 Jul 21, 1982 May 23, 2002 Dec 18, 1997

AB1

A075796 001

Apr 30, 2001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

ETHINYL ESTRADIOL; LEVONORGESTREL
TABLET; ORAL-28 LEVONORGESTREL AND ETHINYL ESTRADIOL AB1 + WATSON LABS 0.02MG;0.1MG ORSYTHIA VINTAGE PHARMS AB1 0.02MG;0.1MG LESSINA-28 BARR AB2 0.02MG;0.1MG LEVONORGESTREL AND ETHINYL ESTRADIOL AB2 + WATSON LABS 0.02MG;0.1MG

3 - 168 (of 424)

A076625 001 A077099 001 A075803 002 A077681 001

Nov 18, 2004 May 11, 2011 Mar 20, 2002 May 31, 2006

ETHINYL ESTRADIOL; NORELGESTROMIN

FILM, EXTENDED RELEASE; TRANSDERMAL

ORTHO EVRA

0.02MG/24HR;0.15MG/24HR XX + JANSSEN PHARMS

N021180 001

Nov 20, 2001

ETHINYL ESTRADIOL; NORETHINDRONE

TABLET; ORAL-21 NORETHIN 1/35E-21 WATSON LABS 0.035MG;1MG NORETHINDRONE AND ETHINYL ESTRADIOL WATSON LABS 0.035MG;1MG NORINYL 1+35 21-DAY WATSON LABS 0.035MG;1MG NORTREL 1/35-21 BARR 0.035MG;1MG NORETHINDRONE AND ETHINYL ESTRADIOL WATSON LABS 0.035MG;0.4MG NORETHINDRONE AND ETHINYL ESTRADIOL (10/11) WATSON LABS 0.035MG,0.035MG;0.5MG,1MG NORETHINDRONE AND ETHINYL ESTRADIOL (7/14) 0.035MG,0.035MG;0.5MG,1MG WATSON LABS NORTREL 7/7/7 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1M BARR G TABLET; ORAL-28 ARANELLE BARR BALZIVA-28 BARR BREVICON 28-DAY WATSON LABS BRIELLYN GLENMARK GENERICS CYCLAFEM 1/35 VINTAGE CYCLAFEM 7/7/7 VINTAGE DASETTA 1/35 NOVAST LABS LTD DASETTA 7/7/7 NOVAST LABS LTD

AB AB AB AB XX XX XX XX

A071480 001 A070685 001 N017565 001 A072693 001 A078379 001 A071043 001 A071041 001 A075478 001

Apr 12, 1988 Jan 29, 1987

Feb 28, 1992 Feb 23, 2010 Apr 01, 1988 Sep 24, 1991 Aug 30, 2002

AB AB AB AB AB AB

0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG 0.035MG;0.4MG 0.035MG;0.5MG 0.035MG;0.4MG 0.035MG;1MG 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1M G 0.035MG;1MG 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1M G

A076783 001 A076238 001 N017743 001 A090538 001 A076337 001 A076338 001

Sep 29, 2004 Apr 22, 2004

Mar 22, 2011 Nov 12, 2010 Nov 16, 2010

AB AB

A090948 001 A090946 001

Dec 22, 2011 Dec 22, 2011

AB AB AB AB

MODICON 28 + JANSSEN PHARMS 0.035MG;0.5MG NORETHIN 1/35E-28 WATSON LABS 0.035MG;1MG NORETHINDRONE AND ETHINYL ESTRADIOL WATSON LABS
0.035MG;0.4MG

0.035MG;0.5MG

N017735 001 A071481 001 A078323 001 A070686 001 Apr 12, 1988 Feb 04, 2010 Jan 29, 1987

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

ETHINYL ESTRADIOL; NORETHINDRONE
TABLET; ORAL-28 NORETHINDRONE AND ETHINYL ESTRADIOL WATSON LABS AB 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1M G AB 0.035MG;1MG NORINYL 1+35 28-DAY WATSON LABS 0.035MG;1MG AB NORTREL 0.5/35-28 BARR 0.035MG;0.5MG AB NORTREL 1/35-28 BARR 0.035MG;1MG AB NORTREL 7/7/7 BARR 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1M AB G ORTHO-NOVUM 1/35-28 AB + JANSSEN PHARMS 0.035MG;1MG ORTHO-NOVUM 7/7/7-28 AB + JANSSEN PHARMS 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1M G OVCON-35 AB + WARNER CHILCOTT 0.035MG;0.4MG PHILITH NOVAST LABS LTD AB 0.035MG;0.4MG TRI-NORINYL 28-DAY AB + WATSON LABS 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG NORETHINDRONE AND ETHINYL ESTRADIOL (10/11) WATSON LABS 0.035MG,0.035MG;0.5MG,1MG XX NORETHINDRONE AND ETHINYL ESTRADIOL (7/14) WATSON LABS 0.035MG,0.035MG;0.5MG,1MG XX OVCON-50 0.05MG;1MG XX + WARNER CHILCOTT TABLET, CHEWABLE; ORAL FEMCON FE + WARNER CHILCOTT 0.035MG;0.4MG NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE BARR 0.035MG;0.4MG WATSON LABS 0.035MG;0.4MG NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE + WATSON LABS INC 0.025MG;0.8MG

3 - 169 (of 424)

A076393 001 A070687 001 N017565 002 A072695 001 A072696 001 A075478 002

Feb 04, 2010 Jan 29, 1987

Feb 28, 1992 Feb 28, 1992 Aug 30, 2002

N017919 002 N018985 002 Apr 04, 1984

N017716 001 A090947 001 N018977 002 A071044 001 A071042 001 N017576 001 Dec 22, 2011 Apr 13, 1984 Apr 01, 1988 Sep 24, 1991

AB AB AB XX

N021490 001 A078965 001 A078892 001 N022573 001

Nov 14, 2003 Aug 05, 2010 Sep 26, 2011 Dec 22, 2010

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

TABLET; ORAL FEMHRT + WARNER CHILCOTT 0.005MG;1MG N021065 002 LOESTRIN 24 FE + WARNER CHILCOTT 0.02MG;1MG N021871 001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL BARR 0.005MG;1MG A076221 001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE WATSON LABS 0.02MG;1MG A078267 001 FEMHRT WARNER CHILCOTT 0.0025MG;0.5MG N021065 001 LO LOESTRIN FE + WARNER CHILCOTT CO 0.01MG,0.01MG;1MG,N/A N022501 001

AB AB AB AB XX XX

Oct 15, 1999 Feb 17, 2006 Nov 06, 2009 Sep 01, 2009 Jan 14, 2005 Oct 21, 2010

TABLET; ORAL-21 JUNEL 1.5/30 BARR AB JUNEL 1/20 BARR AB

0.03MG;1.5MG 0.02MG;1MG

A076381 001 A076380 001

May 30, 2003 May 30, 2003

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
TABLET; ORAL-21 LOESTRIN 21 1.5/30 WARNER CHILCOTT LOESTRIN 21 1/20 WARNER CHILCOTT MICROGESTIN 1.5/30 WATSON LABS MICROGESTIN 1/20 WATSON LABS TRI-LEGEST 21 BARR

3 - 170 (of 424)

AB AB AB AB XX

0.03MG;1.5MG 0.02MG;1MG 0.03MG;1.5MG 0.02MG;1MG 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG

N017875 001 N017876 001 A075548 002 A075647 002 A076405 001 Jul 30, 2003 Jul 30, 2003 Oct 26, 2007

AB AB AB AB AB AB AB AB AB AB AB

TABLET; ORAL-28 ESTROSTEP FE + WARNER CHILCOTT 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG GILDESS FE 1.5/30 VINTAGE 0.03MG;1.5MG GILDESS FE 1/20 VINTAGE 0.02MG;1MG JUNEL FE 1.5/30 BARR 0.03MG;1.5MG JUNEL FE 1/20 BARR 0.02MG;1MG LOESTRIN FE 1.5/30 + WARNER CHILCOTT 0.03MG;1.5MG LOESTRIN FE 1/20 WARNER CHILCOTT 0.02MG;1MG MICROGESTIN FE 1.5/30 WATSON LABS 0.03MG;1.5MG MICROGESTIN FE 1/20 WATSON LABS 0.02MG;1MG NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL WATSON LABS 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG TRI-LEGEST FE BARR 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG

N020130 002 A077075 001 A077077 001 A076064 001 A076081 001 N017355 001 N017354 001 A075548 001 A075647 001 A076629 001 A076105 001

Oct 09, 1996 Apr 28, 2005 May 20, 2005 Sep 18, 2003 Sep 18, 2003

Feb 05, 2001 Feb 05, 2001 Mar 18, 2010 Oct 26, 2007

ETHINYL ESTRADIOL; NORGESTIMATE

TABLET; ORAL NORGESTIMATE AND ETHINYL ESTRADIOL GLENMARK GENERICS AB 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG, 0.25MG TABLET; ORAL-28 NORGESTIMATE AND ETHINYL ESTRADIOL WATSON LABS AB 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG, 0.25MG AB 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG, 0.25MG AB 0.035MG;0.25MG ORTHO CYCLEN-28 AB + JANSSEN PHARMS 0.035MG;0.25MG ORTHO TRI-CYCLEN AB + JANSSEN PHARMS 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG, 0.25MG ORTHO TRI-CYCLEN LO AB + JANSSEN PHARMS 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG, 0.25MG PREVIFEM VINTAGE AB 0.035MG;0.25MG SPRINTEC BARR AB 0.035MG;0.25MG

A200494 001

Jun 17, 2011

A090479 001 A076626 001 A076627 001 N019653 002 N019697 001

Mar 09, 2011 Aug 17, 2006 Aug 17, 2006 Dec 29, 1989 Jul 03, 1992

N021241 001

Aug 22, 2002

A076334 001 A075804 001

Jan 09, 2004 Sep 25, 2002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

ETHINYL ESTRADIOL; NORGESTIMATE
TABLET; ORAL-28 TRI LO SPRINTEC BARR AB TRI-PREVIFEM VINTAGE TRI-SPRINTEC BARR

3 - 171 (of 424)

0.025MG,0.025MG,0.025MG;0.18MG,0.215MG, 0.25MG 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG, 0.25MG 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG, 0.25MG

A076784 001

Jun 29, 2009

AB

A076335 001

Mar 26, 2004

AB

A075808 001

Dec 29, 2003

ETHINYL ESTRADIOL; NORGESTREL

TABLET; ORAL-21 CRYSELLE DURAMED PHARMS BARR AB LOW-OGESTREL-21 AB + WATSON LABS TABLET; ORAL-28 CRYSELLE DURAMED PHARMS BARR LO/OVRAL-28 WYETH PHARMS LOW-OGESTREL-28 WATSON LABS OGESTREL 0.5/50-28 + WATSON LABS

0.03MG;0.3MG 0.03MG;0.3MG

A075840 001 A075288 001

Nov 30, 2001 Jul 28, 1999

AB AB AB XX

0.03MG;0.3MG 0.03MG;0.3MG 0.03MG;0.3MG 0.05MG;0.5MG

A075840 002 N017802 001 A075288 002 A075406 002

Nov 30, 2001

Jul 28, 1999 Dec 15, 1999

ETHIONAMIDE
TABLET; ORAL
TRECATOR
XX + WYETH PHARMS INC

250MG

N013026 002

ETHOSUXIMIDE
CAPSULE; ORAL ETHOSUXIMIDE BANNER PHARMACAPS AB VERSAPHARM AB ZARONTIN AB + PARKE DAVIS SYRUP; ORAL ETHOSUXIMIDE MIKART PHARM ASSOC TEVA PHARMS ZARONTIN + PARKE DAVIS

250MG 250MG 250MG

A040430 001 A040686 001 N012380 001

Oct 28, 2002 May 28, 2008

AA AA AA AA

250MG/5ML 250MG/5ML 250MG/5ML 250MG/5ML

A040506 001 A040253 001 A081306 001 A080258 001

Dec 22, 2003 Nov 22, 2000 Jul 30, 1993

ETHOTOIN
TABLET; ORAL
PEGANONE
XX + LUNDBECK INC

250MG

N010841 001

ETIDRONATE DISODIUM
TABLET; ORAL DIDRONEL PROCTER AND GAMBLE AB AB + ETIDRONATE DISODIUM MYLAN AB

200MG 400MG 200MG

N017831 001 N017831 002 A075800 001 Jan 24, 2003

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

ETIDRONATE DISODIUM
TABLET; ORAL ETIDRONATE DISODIUM MYLAN AB

3 - 172 (of 424)

400MG

A075800 002

Jan 24, 2003

ETODOLAC
CAPSULE; ORAL ETODOLAC APOTEX AB AB TARO AB AB + TEVA AB TABLET; ORAL ETODOLAC APOTEX INC AB AB MYLAN AB AB SANDOZ AB AB TARO PHARM INDS AB AB + TEVA AB AB

200MG 300MG 200MG 300MG 300MG

A075419 A075419 A075078 A075078 A075126

001 002 001 002 002

Jul Jul Apr Apr Sep

28, 28, 30, 30, 16,

2000 2000 1998 1998 1999

400MG 500MG 400MG 500MG 400MG 500MG 400MG 500MG 400MG 500MG

A076004 A076004 A075104 A075104 A074903 A074903 A075074 A075074 A075009 A075009

001 002 001 002 001 002 001 002 001 002

Dec Dec Feb Nov Apr Apr Mar Apr Nov Dec

03, 03, 06, 20, 11, 19, 11, 25, 26, 28,

2002 2002 1998 1998 1997 1999 1998 2000 1997 1999

TABLET, EXTENDED RELEASE; ORAL ETODOLAC TARO AB 400MG AB 500MG AB 600MG TEVA AB 400MG AB 500MG AB + 600MG

A076174 A076174 A076174 A075665 A075665 A075665

001 002 003 003 002 001

Mar Mar Mar Feb Jul Jul

13, 13, 13, 05, 31, 31,

2003 2003 2003 2001 2000 2000

ETOMIDATE
INJECTABLE; INJECTION AMIDATE + HOSPIRA ETOMIDATE BEDFORD LUITPOLD STRIDES ARCOLAB LTD

AP AP AP AP

2MG/ML 2MG/ML 2MG/ML 2MG/ML

N018227 001 A074593 001 A078867 001 A078289 001

Sep 07, 1982 Nov 04, 1996 Dec 22, 2009 Jan 02, 2009

ETONOGESTREL
IMPLANT; IMPLANTATION

IMPLANON

XX + ORGANON USA INC NEXPLANON XX + ORGANON USA INC

68MG/IMPLANT 68MG/IMPLANT

N021529 001 N021529 002

Jul 17, 2006 May 31, 2011

ETOPOSIDE

CAPSULE; ORAL

ETOPOSIDE
XX + MYLAN INJECTABLE; INJECTION ETOPOSIDE ACCORD HLTHCARE INC AP APP PHARMS AP AP + BEDFORD

50MG

A075635 001

Sep 19, 2001

20MG/ML 20MG/ML 20MG/ML

A074513 001 A074983 001 A074290 001

Mar 14, 1996 Sep 30, 1998 Jul 17, 1995

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

ETOPOSIDE
INJECTABLE; INJECTION ETOPOSIDE PHARMACHEMIE AP TEVA PARENTERAL AP AP

3 - 173 (of 424)

20MG/ML 20MG/ML 20MG/ML

A074227 001 A074284 001 A074529 001

Feb 22, 1996 Feb 10, 1994 Jul 24, 1996

ETOPOSIDE PHOSPHATE
INJECTABLE; INJECTION

ETOPOPHOS PRESERVATIVE FREE

XX + BRISTOL MYERS SQUIBB EQ 100MG BASE/VIAL

N020457 001

May 17, 1996

ETRAVIRINE
TABLET; ORAL
INTELENCE
TIBOTEC
XX XX +

100MG 200MG

N022187 001 N022187 002

Jan 18, 2008 Dec 22, 2010

EVEROLIMUS
TABLET; ORAL
AFINITOR
NOVARTIS
XX XX XX +
ZORTRESS
NOVARTIS
XX XX XX +

2.5MG 5MG 10MG 0.25MG 0.5MG 0.75MG

N022334 003 N022334 001 N022334 002 N021560 001 N021560 002 N021560 003

Jul 09, 2010 Mar 30, 2009 Mar 30, 2009 Apr 20, 2010 Apr 20, 2010 Apr 20, 2010

EXEMESTANE
TABLET; ORAL AROMASIN AB + PHARMACIA AND UPJOHN EXEMESTANE ROXANE AB

25MG 25MG

N020753 001 A077431 001

Oct 21, 1999 Apr 01, 2011

EXENATIDE SYNTHETIC
INJECTABLE; SUBCUTANEOUS
BYETTA
XX + AMYLIN
XX +

300MCG/1.2ML (250MCG/ML) 600MCG/2.4ML (250MCG/ML)

N021773 001 N021773 002

Apr 28, 2005 Apr 28, 2005

EZETIMIBE

TABLET; ORAL

ZETIA
XX + MSP SINGAPORE

10MG

N021445 001

Oct 25, 2002

EZETIMIBE; SIMVASTATIN
TABLET; ORAL
VYTORIN
MSD INTL
XX XX XX XX +

10MG;10MG 10MG;20MG 10MG;40MG 10MG;80MG

N021687 N021687 N021687 N021687

001 002 003 004

Jul Jul Jul Jul

23, 23, 23, 23,

2004 2004 2004 2004

EZOGABINE
TABLET; ORAL
POTIGA
VALEANT PHARMS
XX

50MG

N022345 001

Jun 10, 2011

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

EZOGABINE
TABLET; ORAL POTIGA VALEANT PHARMS XX XX XX +

3 - 174 (of 424)

200MG 300MG 400MG

N022345 002 N022345 003 N022345 004

Jun 10, 2011 Jun 10, 2011 Jun 10, 2011

FAMCICLOVIR
TABLET; ORAL FAMCICLOVIR APOTEX AB AB AB AUROBINDO PHARMA LTD AB AB AB MYLAN AB AB AB ROXANE AB AB AB TEVA PHARMS AB AB AB WATSON LABS AB AB AB FAMVIR NOVARTIS AB AB AB +

125MG 250MG 500MG 125MG 250MG 500MG 125MG 250MG 500MG 125MG 250MG 500MG 125MG 250MG 500MG 125MG 250MG 500MG 125MG 250MG 500MG

A091480 A091480 A091480 A091114 A091114 A091114 A201333 A201333 A201333 A090128 A090128 A090128 A077487 A077487 A077487 A078278 A078278 A078278

001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003

Jul Jul Jul Mar Mar Mar Mar Mar Mar Mar Mar Mar Aug Aug Aug Mar Mar Mar

22, 22, 22, 21, 21, 21, 24, 24, 24, 21, 21, 21, 24, 24, 24, 21, 21, 21,

2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2007 2007 2007 2011 2011 2011

N020363 003 N020363 001 N020363 002

Dec 11, 1995 Apr 26, 1996 Jun 29, 1994

FAMOTIDINE
FOR SUSPENSION; ORAL FAMOTIDINE LUPIN LTD AB NAVINTA LLC AB PEPCID AB + SALIX PHARMS INJECTABLE; INJECTION FAMOTIDINE APP PHARMS + BAXTER HLTHCARE + BEDFORD

40MG/5ML 40MG/5ML 40MG/5ML

A090440 001 A091020 001 N019527 001

Jun 29, 2010 May 27, 2010 Feb 02, 1987

AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP

10MG/ML 10MG/ML 10MG/ML 10MG/ML 10MG/ML PFIZER 10MG/ML FAMOTIDINE PRESERVATIVE FREE APP PHARMS 10MG/ML + BAXTER HLTHCARE 10MG/ML + 10MG/ML BEDFORD 10MG/ML BEN VENUE 10MG/ML CLARIS LIFESCIENCES 10MG/ML PFIZER 10MG/ML FAMOTIDINE PRESERVATIVE FREE (PHARMACY BULK) CLARIS LIFESCIENCES 10MG/ML FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER + BAXTER HLTHCARE 0.4MG/ML

A075709 A075488 A075799 A075651 A075684 A078641 A075813 A075486 A075789 A075622 A075825 A076324 A078642

001 001 001 001 001 001 001 001 001 001 001 001 001

Apr Apr Apr Apr Apr Jun Apr Apr Apr Apr Apr Nov Jun

16, 16, 30, 16, 16, 25, 16, 16, 30, 16, 17, 27, 25,

2001 2001 2002 2001 2001 2008 2001 2001 2002 2001 2001 2002 2008

A076322 001 A075591 001

Nov 27, 2002 May 10, 2001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

FAMOTIDINE
TABLET; ORAL FAMOTIDINE ALEMBIC PHARMS LTD AB AB APOTEX AB AB CARLSBAD AB AB DR REDDYS LABS LTD AB AB IVAX SUB TEVA PHARMS AB AB MYLAN AB AB AB AB PERRIGO AB AB SANDOZ AB AB TEVA AB AB WATSON LABS AB AB WOCKHARDT AB AB PEPCID MERCK AB AB +

3 - 175 (of 424)

20MG 40MG 20MG 40MG 20MG 40MG 20MG 40MG 20MG 40MG 20MG 20MG 40MG 40MG 20MG 40MG 20MG 40MG 20MG 40MG 20MG 40MG 20MG 40MG 20MG 40MG

A078916 A078916 A075611 A075611 A075805 A075805 A075718 A075718 A075511 A075511 A075457 A075704 A075457 A075704 A077352 A077352 A075607 A075607 A075311 A075311 A075062 A075062 A075786 A075786

001 002 001 002 001 002 001 002 001 002 001 001 002 002 002 001 001 002 001 002 002 001 001 002

May May Jul Jul Apr Apr Apr Apr Apr Apr Apr Apr Apr Apr Jul Jul May May Apr Apr Apr Apr Apr Apr

22, 22, 23, 23, 16, 16, 16, 16, 16, 16, 18, 16, 18, 16, 27, 27, 10, 10, 16, 16, 16, 16, 16, 16,

2009 2009 2001 2001 2001 2001 2001 2001 2001 2001 2001 2001 2001 2001 2005 2005 2001 2001 2001 2001 2001 2001 2001 2001

N019462 001 N019462 002

Oct 15, 1986 Oct 15, 1986

FAMOTIDINE; IBUPROFEN
TABLET; ORAL
DUEXIS
XX + HORIZON PHARMA

26.6MG;800MG

N022519 001

Apr 23, 2011

FEBUXOSTAT
TABLET; ORAL ULORIC TAKEDA PHARMS XX XX +

40MG 80MG

N021856 001 N021856 002

Feb 13, 2009 Feb 13, 2009

FELBAMATE
SUSPENSION; ORAL FELBAMATE AMNEAL PHARMS AB FELBATOL AB + MEDA PHARMS TABLET; ORAL FELBAMATE AMNEAL PHARMS AB AB FELBATOL MEDA PHARMS AB AB +

600MG/5ML 600MG/5ML

A202385 001 N020189 003

Dec 16, 2011 Jul 29, 1993

400MG 600MG 400MG 600MG

A201680 001 A201680 002 N020189 001 N020189 002

Sep 13, 2011 Sep 13, 2011 Jul 29, 1993 Jul 29, 1993

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

FELODIPINE
TABLET, EXTENDED RELEASE; ORAL FELODIPINE ENDO PHARMS AB 2.5MG AB 5MG AB 10MG GLENMARK GENERICS AB 2.5MG AB 5MG AB 10MG MUTUAL PHARM AB 2.5MG AB 5MG AB 10MG MYLAN AB 2.5MG AB 5MG AB + 10MG TORRENT PHARMS LTD AB 2.5MG AB 5MG AB 10MG PLENDIL ASTRAZENECA AB 2.5MG AB 5MG AB 10MG

3 - 176 (of 424)

A200815 A200815 A200815 A090365 A090365 A090365 A075896 A075896 A075896 A078855 A078855 A078855 A202170 A202170 A202170

001 002 003 001 002 003 001 002 003 001 002 003 001 002 003

Oct Oct Oct Dec Dec Dec Nov Nov Nov Apr Apr Apr Nov Nov Nov

28, 28, 28, 17, 17, 17, 02, 02, 02, 17, 17, 17, 28, 28, 28,

2011 2011 2011 2010 2010 2010 2004 2004 2004 2008 2008 2008 2011 2011 2011

N019834 004 N019834 001 N019834 002

Sep 22, 1994 Jul 25, 1991 Jul 25, 1991

FENOFIBRATE
CAPSULE; ORAL FENOFIBRATE (MICRONIZED) IMPAX LABS 67MG 134MG 200MG TEVA 67MG 134MG + 200MG ANTARA (MICRONIZED) LUPIN ATLANTIS 43MG + 130MG LIPOFEN CIPHER PHARMS INC 50MG + 150MG

AB AB AB AB AB AB XX XX XX XX

A075868 A075868 A075868 A075753 A075753 A075753

001 002 003 001 002 003

Oct Oct Oct Sep Apr Apr

27, 27, 27, 03, 09, 09,

2003 2003 2003 2002 2002 2002

N021695 001 N021695 003 N021612 001 N021612 003

Nov 30, 2004 Nov 30, 2004 Jan 11, 2006 Jan 11, 2006

TABLET; ORAL FENOFIBRATE IMPAX LABS AB AB LUPIN LTD AB AB MYLAN AB AB RANBAXY AB AB TEVA AB AB + TRICOR ABBOTT LABS PHARM AB AB + TRIGLIDE BX + SKYEPHARMA AG FENOFIBRATE RANBAXY XX FENOGLIDE SANTARUS XX XX +

54MG 160MG 48MG 145MG 54MG 160MG 54MG 160MG 54MG 160MG 48MG 145MG 160MG 107MG 40MG 120MG

A076509 A076509 A090856 A090856 A076520 A076520 A076635 A076635 A076433 A076433

001 002 001 002 001 003 001 003 001 002

Mar Mar Dec Dec Oct Oct Oct Oct May May

26, 26, 23, 23, 25, 25, 31, 31, 13, 13,

2008 2008 2011 2011 2007 2007 2005 2005 2005 2005

N021656 001 N021656 002 N021350 002 A076635 002 N022118 001 N022118 002

Nov 05, 2004 Nov 05, 2004 May 07, 2005 Oct 31, 2005 Aug 10, 2007 Aug 10, 2007

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

FENOFIBRATE
TABLET; ORAL TRIGLIDE SKYEPHARMA AG XX

3 - 177 (of 424)

50MG

N021350 001

May 07, 2005

FENOFIBRIC ACID
TABLET; ORAL FIBRICOR AR HOLDING CO INC XX XX +

35MG 105MG

N022418 001 N022418 002

Aug 14, 2009 Aug 14, 2009

FENOLDOPAM MESYLATE
INJECTABLE; INJECTION CORLOPAM AP + HOSPIRA FENOLDOPAM MESYLATE BEDFORD LABS AP SANDOZ AP

EQ 10MG BASE/ML EQ 10MG BASE/ML EQ 10MG BASE/ML

N019922 001 A076582 001 A077155 001

Sep 23, 1997 Oct 12, 2004 Feb 15, 2005

FENOPROFEN CALCIUM
CAPSULE; ORAL
NALFON
XX + PEDINOL XX TABLET; ORAL FENOPROFEN CALCIUM IVAX SUB TEVA PHARMS AB AB + MYLAN

EQ 200MG BASE EQ 400MG BASE

N017604 003 N017604 004

Jul 21, 2009

EQ 600MG BASE EQ 600MG BASE

A072557 001 A072267 001

Aug 29, 1988 Aug 17, 1988

FENTANYL
FILM, EXTENDED RELEASE; TRANSDERMAL DURAGESIC-100 JANSSEN PHARMS 100MCG/HR DURAGESIC-12 JANSSEN PHARMS 12.5MCG/HR DURAGESIC-25 + JANSSEN PHARMS 25MCG/HR DURAGESIC-50 JANSSEN PHARMS 50MCG/HR DURAGESIC-75 JANSSEN PHARMS 75MCG/HR FENTANYL-100 ACTAVIS 100MCG/HR LAVIPHARM LABS 100MCG/HR MALLINCKRODT INC 100MCG/HR MYLAN TECHNOLOGIES 100MCG/HR NOVEN 100MCG/HR TEVA PHARMS 100MCG/HR WATSON LABS 100MCG/HR FENTANYL-12 MYLAN TECHNOLOGIES 12.5MCG/HR FENTANYL-25 ACTAVIS 25MCG/HR LAVIPHARM LABS 25MCG/HR MALLINCKRODT INC 25MCG/HR MYLAN TECHNOLOGIES 25MCG/HR NOVEN 25MCG/HR TEVA PHARMS 25MCG/HR WATSON LABS 25MCG/HR

AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB

N019813 001 N019813 005 N019813 004 N019813 003 N019813 002 A077062 A077051 A077154 A076258 A077775 A077449 A076709 004 004 004 004 004 004 004

Aug 07, 1990 Feb 04, 2005 Aug 07, 1990 Aug 07, 1990 Aug 07, 1990 Aug Aug Feb Jan Oct Oct Aug 20, 04, 09, 28, 16, 20, 20, 2007 2006 2011 2005 2009 2008 2007

A076258 005 A077062 A077051 A077154 A076258 A077775 A077449 A076709 001 001 001 001 001 001 001

Jan 23, 2007 Aug Aug Feb Jan Oct Oct Aug 20, 04, 09, 28, 16, 20, 20, 2007 2006 2011 2005 2009 2008 2007

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

FENTANYL
FILM, EXTENDED RELEASE; TRANSDERMAL FENTANYL-50 ACTAVIS 50MCG/HR LAVIPHARM LABS 50MCG/HR MALLINCKRODT INC 50MCG/HR MYLAN TECHNOLOGIES 50MCG/HR NOVEN 50MCG/HR TEVA PHARMS 50MCG/HR WATSON LABS 50MCG/HR FENTANYL-75 ACTAVIS 75MCG/HR LAVIPHARM LABS 75MCG/HR MALLINCKRODT INC 75MCG/HR MYLAN TECHNOLOGIES 75MCG/HR NOVEN 75MCG/HR TEVA PHARMS 75MCG/HR WATSON LABS 75MCG/HR

3 - 178 (of 424)

AB AB AB AB AB AB AB AB AB AB AB AB AB AB

A077062 A077051 A077154 A076258 A077775 A077449 A076709 A077062 A077051 A077154 A076258 A077775 A077449 A076709

002 002 002 002 002 002 002 003 003 003 003 003 003 003

Aug Aug Feb Jan Oct Oct Aug Aug Aug Feb Jan Oct Oct Aug

20, 04, 09, 28, 16, 20, 20, 20, 04, 09, 28, 16, 20, 20,

2007 2006 2011 2005 2009 2008 2007 2007 2006 2011 2005 2009 2008 2007

FENTANYL CITRATE
FILM; BUCCAL ONSOLIS MEDA PHARMS XX XX + XX XX XX

EQ EQ EQ EQ EQ

0.2MG 0.4MG 0.6MG 0.8MG 1.2MG

BASE BASE BASE BASE BASE

N022266 N022266 N022266 N022266 N022266

001 002 003 004 005

Jul Jul Jul Jul Jul

16, 16, 16, 16, 16,

2009 2009 2009 2009 2009

AP AP AP AP

INJECTABLE; INJECTION FENTANYL CITRATE HOSPIRA EQ 0.05MG BASE/ML FENTANYL CITRATE PRESERVATIVE FREE + BAXTER HLTHCARE EQ 0.05MG BASE/ML HOSPIRA EQ 0.05MG BASE/ML SUBLIMAZE PRESERVATIVE FREE + AKORN EQ 0.05MG BASE/ML

N019115 001 N019101 001 A072786 001 N016619 001

Jan 12, 1985 Jul 11, 1984 Sep 24, 1991

SPRAY, METERED; NASAL LAZANDA ARCHIMEDES XX XX + TABLET; BUCCAL FENTANYL CITRATE WATSON LABS AB AB AB AB AB FENTORA CEPHALON AB AB AB + AB AB TABLET; SUBLINGUAL ABSTRAL PROSTRAKAN INC XX XX XX XX + XX

100MCG 400MCG

N022569 001 N022569 002

Jun 30, 2011 Jun 30, 2011

EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ

0.1MG 0.2MG 0.4MG 0.6MG 0.8MG 0.1MG 0.2MG 0.4MG 0.6MG 0.8MG

BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE

A079075 A079075 A079075 A079075 A079075 N021947 N021947 N021947 N021947 N021947

001 002 003 004 005 001 002 003 004 005

Jan Jan Jan Jan Jan Sep Sep Sep Sep Sep

07, 07, 07, 07, 07, 25, 25, 25, 25, 25,

2011 2011 2011 2011 2011 2006 2006 2006 2006 2006

EQ EQ EQ EQ EQ

0.1MG 0.2MG 0.3MG 0.4MG 0.6MG

BASE BASE BASE BASE BASE

N022510 N022510 N022510 N022510 N022510

001 002 003 004 005

Jan Jan Jan Jan Jan

07, 07, 07, 07, 07,

2011 2011 2011 2011 2011

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

FENTANYL CITRATE
TABLET; SUBLINGUAL ABSTRAL PROSTRAKAN INC XX

3 - 179 (of 424)

EQ 0.8MG BASE

N022510 006

Jan 07, 2011

TROCHE/LOZENGE; TRANSMUCOSAL ACTIQ CEPHALON AB EQ 0.2MG BASE AB + EQ 0.4MG BASE AB EQ 0.6MG BASE AB EQ 0.8MG BASE AB EQ 1.2MG BASE AB EQ 1.6MG BASE FENTANYL CITRATE BARR AB EQ 0.2MG BASE AB EQ 0.4MG BASE AB EQ 0.6MG BASE AB EQ 0.8MG BASE AB EQ 1.2MG BASE AB EQ 1.6MG BASE MALLINCKRODT AB EQ 0.2MG BASE AB EQ 0.4MG BASE AB EQ 0.6MG BASE AB EQ 0.8MG BASE AB EQ 1.2MG BASE AB EQ 1.6MG BASE

N020747 N020747 N020747 N020747 N020747 N020747 A077312 A077312 A077312 A077312 A077312 A077312 A078907 A078907 A078907 A078907 A078907 A078907

001 002 003 004 005 006 001 002 003 004 005 006 001 002 003 004 005 006

Nov Nov Nov Nov Nov Nov Oct Oct Oct Oct Oct Oct Oct Oct Oct Oct Oct Oct

04, 04, 04, 04, 04, 04, 30, 30, 30, 30, 30, 30, 30, 30, 30, 30, 30, 30,

1998 1998 1998 1998 1998 1998 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009

FERRIC HEXACYANOFERRATE(II)
CAPSULE; ORAL

RADIOGARDASE (PRUSSIAN BLUE)

500MG XX + HEYL CHEMISCH

N021626 001

Oct 02, 2003

FERUMOXIDES

INJECTABLE; INJECTION

FERIDEX I.V.
XX + AMAG PHARMS INC

EQ 11.2MG IRON/ML

N020416 001

Aug 30, 1996

FERUMOXSIL

SUSPENSION; ORAL

GASTROMARK
XX + AMAG PHARMS INC

EQ 0.175MG IRON/ML

N020410 001

Dec 06, 1996

FERUMOXYTOL

SOLUTION; INTRAVENOUS

FERAHEME
XX + AMAG PHARMS INC

EQ 510MG IRON/17ML (EQ 30MG IRON/ML)

N022180 001

Jun 30, 2009

FESOTERODINE FUMARATE
TABLET, EXTENDED RELEASE; ORAL TOVIAZ PFIZER 4MG XX 8MG XX +

N022030 001 N022030 002

Oct 31, 2008 Oct 31, 2008

FEXOFENADINE HYDROCHLORIDE

SUSPENSION; ORAL

ALLEGRA
XX + SANOFI AVENTIS US

30MG/5ML

N021963 001

Oct 16, 2006

TABLET; ORAL FEXOFENADINE HYDROCHLORIDE BARR AB 30MG

A076191 001

Aug 31, 2005

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

FEXOFENADINE HYDROCHLORIDE
TABLET; ORAL FEXOFENADINE HYDROCHLORIDE BARR 60MG AB 180MG AB DR REDDYS LABS LTD 30MG AB 60MG AB 180MG AB MYLAN 30MG AB 60MG AB 180MG AB TEVA 30MG AB 60MG AB 180MG AB

3 - 180 (of 424)

A076191 A076191 A076502 A076502 A076502 A077081 A077081 A077081 A076447 A076447 A076447

002 003 001 002 003 002 003 001 001 002 003

Aug Aug Apr Apr Apr Apr Apr Apr Sep Sep Sep

31, 31, 11, 11, 11, 11, 11, 16, 01, 01, 01,

2005 2005 2006 2006 2006 2008 2008 2007 2005 2005 2005

FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

TABLET, EXTENDED RELEASE; ORAL FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE BARR AB 60MG;120MG IMPAX PHARMS AB 60MG;120MG

A076236 001 A076298 001

Apr 14, 2005 Nov 12, 2010

FIDAXOMICIN
TABLET; ORAL DIFICID XX + OPTIMER PHARMS

200MG

N201699 001

May 27, 2011

FINASTERIDE
TABLET; ORAL FINASTERIDE ACCORD HLTHCARE INC ACTAVIS TOTOWA AUROBINDO PHARMA DR REDDYS LABS INC DR REDDYS LABS LTD GEDEON RICHTER USA HETERO DRUGS LTD MYLAN SUN PHARMA GLOBAL TEVA ZYDUS PHARMS USA INC PROPECIA + MERCK PROSCAR + MERCK

AB AB AB AB AB AB AB AB AB AB AB AB AB

5MG 5MG 5MG 1MG 5MG 5MG 5MG 5MG 5MG 5MG 5MG 1MG 5MG

A090121 A077914 A078341 A076436 A076437 A077251 A090061 A077578 A090507 A076511 A078900

001 001 001 001 001 001 001 001 001 001 001

Feb Mar Oct Jul Feb Dec Jun Dec Aug Dec Dec

23, 28, 30, 28, 28, 22, 07, 18, 16, 15, 28,

2010 2007 2007 2006 2007 2006 2010 2006 2011 2006 2009

N020788 001 N020180 001

Dec 19, 1997 Jun 19, 1992

FINGOLIMOD
CAPSULE; ORAL
GILENYA
XX + NOVARTIS

0.5MG

N022527 001

Sep 21, 2010

FLAVOXATE HYDROCHLORIDE
TABLET; ORAL FLAVOXATE HYDROCHLORIDE EPIC PHARMA 100MG AB IMPAX PHARMS 100MG AB 100MG AB + PADDOCK LLC

A076835 001 A076234 001 A076831 001

Nov 30, 2005 Aug 28, 2003 Dec 16, 2004

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

FLECAINIDE ACETATE
TABLET; ORAL FLECAINIDE ACETATE AMNEAL PHARM AB AB AB APOTEX INC AB AB AB BARR AB AB AB RANBAXY AB AB AB ROXANE AB AB AB TAMBOCOR MEDICIS AB AB AB +

3 - 181 (of 424)

50MG 100MG 150MG 50MG 100MG 150MG 50MG 100MG 150MG 50MG 100MG 150MG 50MG 100MG 150MG 50MG 100MG 150MG

A075442 A075442 A075442 A079164 A079164 A079164 A075882 A075882 A075882 A076421 A076421 A076421 A076278 A076278 A076278

001 002 003 001 002 003 001 002 003 001 002 003 001 002 003

Jul Jul Jul Jul Jul Jul Oct Oct Oct Mar Mar Mar Jan Jan Jan

31, 31, 31, 09, 09, 09, 28, 28, 28, 28, 28, 28, 14, 14, 14,

2001 2001 2001 2009 2009 2009 2002 2002 2002 2003 2003 2003 2003 2003 2003

N018830 004 N018830 001 N018830 003

Aug 23, 1988 Oct 31, 1985 Jun 03, 1988

FLOXURIDINE
INJECTABLE; INJECTION FLOXURIDINE APP PHARMS AP AP + BEDFORD

500MG/VIAL 500MG/VIAL

A075837 001 A075387 001

Feb 22, 2001 Apr 16, 2000

FLUCONAZOLE
FOR SUSPENSION; ORAL DIFLUCAN PFIZER AB AB + FLUCONAZOLE AUROBINDO PHARM AB AB IVAX SUB TEVA PHARMS AB AB RANBAXY AB AB ROXANE AB AB TARO PHARM INDS AB AB

50MG/5ML 200MG/5ML 50MG/5ML 200MG/5ML 50MG/5ML 200MG/5ML 50MG/5ML 200MG/5ML 50MG/5ML 200MG/5ML 50MG/5ML 200MG/5ML

N020090 001 N020090 002 A079150 A079150 A077523 A077523 A076332 A076332 A076246 A076246 A076918 A076918 001 002 001 002 001 002 001 002 001 002

Dec 23, 1993 Dec 23, 1993 Sep Sep Sep Sep Jul Jul Jul Jul Dec Dec 18, 18, 12, 12, 29, 29, 29, 29, 18, 18, 2009 2009 2007 2007 2004 2004 2004 2004 2006 2006

AP AP AP AP AP AP AP AP AP

INJECTABLE; INJECTION DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER + PFIZER 200MG/100ML (2MG/ML) + 400MG/200ML (2MG/ML) DIFLUCAN IN SODIUM CHLORIDE 0.9% + PFIZER 200MG/100ML (2MG/ML) + 400MG/200ML (2MG/ML) DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER + PFIZER 200MG/100ML (2MG/ML) + 400MG/200ML (2MG/ML) FLUCANAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER ACS DOBFAR INFO SA 200MG/100ML (2MG/ML) 400MG/200ML (2MG/ML) FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER APOTEX INC 200MG/100ML (2MG/ML)

N019950 003 N019950 005 N019950 001 N019950 006 N019950 002 N019950 004 A079104 001 A079104 002 A076888 001

Sep 29, 1992 Jul 08, 1994 Jan 29, 1990 Jan 29, 1990 Jan 29, 1990 Jan 29, 1990 Jul 30, 2009 Jul 30, 2009 Mar 25, 2005

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

FLUCONAZOLE
INJECTABLE; INJECTION FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER APOTEX INC AP 400MG/200ML (2MG/ML) HOSPIRA AP 200MG/100ML (2MG/ML) AP 400MG/200ML (2MG/ML) FLUCONAZOLE IN SODIUM CHLORIDE 0.9% APP PHARMS AP 200MG/100ML (2MG/ML) AP 400MG/200ML (2MG/ML) BEDFORD AP 200MG/100ML (2MG/ML) AP 400MG/200ML (2MG/ML) CLARIS LIFESCIENCES AP 200MG/100ML (2MG/ML) AP 400MG/200ML (2MG/ML) HIKMA FARMACEUTICA AP 200MG/100ML (2MG/ML) TEVA PARENTERAL AP 200MG/100ML (2MG/ML) AP 400MG/200ML (2MG/ML) FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER BAXTER HLTHCARE AP 200MG/100ML (2MG/ML) AP 400MG/200ML (2MG/ML) BEDFORD LABS AP 200MG/100ML (2MG/ML) AP 400MG/200ML (2MG/ML) CLARIS LIFESCIENCES AP 200MG/100ML (2MG/ML) AP 400MG/200ML (2MG/ML) HOSPIRA AP 200MG/100ML (2MG/ML) AP 400MG/200ML (2MG/ML) TEVA PARENTERAL AP 200MG/100ML (2MG/ML) AP 400MG/200ML (2MG/ML) FULCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER CLARIS LIFESCIENCES AP 200MG/100ML (2MG/ML) AP 400MG/200ML (2MG/ML) FLUCONAZOLE IN SODIUM CHLORIDE 0.9% BEDFORD 100MG/50ML (2MG/ML) XX TABLET; ORAL DIFLUCAN PFIZER AB AB AB AB + FLUCONAZOLE AMNEAL PHARM AB AB AB AB APOTEX AB AB AB AB AUROBINDO PHARMA AB AB AB AB GLENMARK GENERICS AB AB AB AB IVAX SUB TEVA PHARMS AB AB AB AB MYLAN AB

3 - 182 (of 424)

A076888 002 A076304 001 A076304 002 A076145 A076145 A076087 A076087 A077947 A077947 A076736 A076653 A076653 A076766 A076766 A078107 A078107 A077909 A077909 A076303 A076303 A076837 A076837 001 002 001 003 001 002 001 001 002 001 002 001 002 001 002 001 002 001 002

Mar 25, 2005 Jul 29, 2004 Jul 29, 2004 Jul Jul Jul Jul May May Aug Jul Jul Jul Jul Jul Jul May May Jul Jul Jan Jan 29, 29, 29, 29, 26, 26, 23, 29, 29, 29, 29, 30, 30, 26, 26, 29, 29, 13, 13, 2004 2004 2004 2004 2010 2010 2005 2004 2004 2004 2004 2008 2008 2010 2010 2004 2004 2005 2005

A077988 001 A077988 002 A076087 002

May 26, 2010 May 26, 2010 Sep 26, 2008

50MG 100MG 150MG 200MG 50MG 100MG 150MG 200MG 50MG 100MG 150MG 200MG 50MG 100MG 150MG 200MG 50MG 100MG 150MG 200MG 50MG 100MG 150MG 200MG 50MG

N019949 N019949 N019949 N019949 A078423 A078423 A078423 A078423 A076665 A076665 A076665 A076665 A077731 A077731 A077731 A077731 A077253 A077253 A077253 A077253 A076077 A076077 A076077 A076077 A076042

001 002 004 003 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001

Jan Jan Jun Jan Mar Mar Mar Mar Jul Jul Jul Jul Oct Oct Oct Oct Jan Jan Jan Jan Jul Jul Jul Jul Jul

29, 29, 30, 29, 07, 07, 07, 07, 29, 29, 29, 29, 07, 07, 07, 07, 25, 25, 25, 25, 29, 29, 29, 29, 29,

1990 1990 1994 1990 2011 2011 2011 2011 2004 2004 2004 2004 2008 2008 2008 2008 2006 2006 2006 2006 2004 2004 2004 2004 2004

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

FLUCONAZOLE
TABLET; ORAL FLUCONAZOLE MYLAN AB AB AB AB AB AB AB RANBAXY AB AB AB AB TARO AB AB AB AB TEVA AB AB AB AB UNIQUE PHARM LABS AB AB AB FLUCONAZOLE BX DR REDDYS LABS INC BX BX BX BX PLIVA BX BX BX

3 - 183 (of 424)

50MG 100MG 100MG 150MG 150MG 200MG 200MG 50MG 100MG 150MG 200MG 50MG 100MG 150MG 200MG 50MG 100MG 150MG 200MG 50MG 100MG 200MG 50MG 100MG 150MG 200MG 50MG 100MG 150MG 200MG

A076351 A076042 A076351 A076042 A076351 A076042 A076351 A076386 A076386 A076386 A076386 A076507 A076507 A076507 A076507 A074681 A074681 A074681 A074681 A076957 A076957 A076957 A076658 A076658 A076658 A076658 A076424 A076424 A076424 A076424

001 002 002 003 003 004 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 001 002 003 004 001 002 003 004

Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul Sep Sep Sep Jul Jul Jul Jul Jul Jul Jul Jul

29, 29, 29, 29, 29, 29, 29, 29, 29, 29, 29, 29, 29, 29, 29, 29, 29, 29, 29, 28, 28, 28, 29, 29, 29, 29, 29, 29, 29, 29,

2004 2004 2004 2004 2004 2004 2004 2004 2004 2004 2004 2004 2004 2004 2004 2004 2004 2004 2004 2005 2005 2005 2004 2004 2004 2004 2004 2004 2004 2004

FLUCYTOSINE
CAPSULE; ORAL ANCOBON VALEANT AB AB + FLUCYTOSINE SIGMAPHARM LABS LLC AB AB

250MG 500MG 250MG 500MG

N017001 001 N017001 002 A201566 001 A201566 002 Jun 28, 2011 Jun 28, 2011

FLUDARABINE PHOSPHATE
INJECTABLE; INJECTION FLUDARA AP + GENZYME FLUDARABINE PHOSPHATE ACTAVIS TOTOWA AP APP PHARMS AP AP BIONICHE PHARMA USA AP HOSPIRA AP ONCO THERAPIES LTD AP AP + SANDOZ TEVA PARENTERAL AP AP +

50MG/VIAL 50MG/VIAL 50MG/2ML (25MG/ML) 50MG/VIAL 50MG/2ML (25MG/ML) 50MG/VIAL 50MG/2ML (25MG/ML) 50MG/2ML (25MG/ML) 50MG/VIAL 50MG/2ML (25MG/ML)

N020038 001 A078610 A078393 A078544 A090724 A077790 A200647 N022137 A076349 A076661 001 001 001 001 001 001 001 001 001

Apr 18, 1991 Feb Oct Oct Sep Apr Dec Sep Aug Apr 11, 15, 15, 27, 06, 21, 21, 28, 28, 2009 2007 2007 2010 2007 2011 2007 2003 2004

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

FLUDARABINE PHOSPHATE

TABLET; ORAL

OFORTA
XX + SANOFI AVENTIS US

3 - 184 (of 424)

10MG

N022273 001

Dec 18, 2008

FLUDEOXYGLUCOSE F-18
INJECTABLE; INTRAVENOUS FLUDEOXYGLUCOSE F18 + FEINSTEIN PETNET FLUDEOXYGLUCOSE F 18 + WEILL MEDCL COLL FLUDEOXYGLUCOSE F18 + FEINSTEIN

AP AP XX XX

20-200mCi/ML 20-200mCi/ML 10-100mCi/ML 20-300mCi/ML

N021870 001 A079086 001 N021768 001 N021870 002

Aug 19, 2005 Feb 25, 2011 Aug 05, 2004 Nov 21, 2008

FLUDROCORTISONE ACETATE
TABLET; ORAL FLUDROCORTISONE ACETATE BARR AB 0.1MG AB + IMPAX LABS 0.1MG WEST-WARD PHARM CORP 0.1MG AB

A040425 001 A040431 001 A091302 001

Jan 21, 2003 Mar 18, 2002 Jul 22, 2011

FLUMAZENIL
INJECTABLE; INJECTION FLUMAZENIL APP PHARMS AP AP BAXTER HLTHCARE AP AP BEDFORD LABS AP AP CLARIS LIFESCIENCES AP AP HIKMA FARMACEUTICA AP AP PFIZER AP AP SANDOZ AP AP TEVA PARENTERAL AP AP ROMAZICON AP + HOFFMANN LA ROCHE AP

0.5MG/5ML (0.1MG/ML) 1MG/10ML (0.1MG/ML) 0.5MG/5ML (0.1MG/ML) 1MG/10ML (0.1MG/ML) 0.5MG/5ML (0.1MG/ML) 1MG/10ML (0.1MG/ML) 0.5MG/5ML (0.1MG/ML) 1MG/10ML (0.1MG/ML) 0.5MG/5ML (0.1MG/ML) 1MG/10ML (0.1MG/ML) 0.5MG/5ML (0.1MG/ML) 1MG/10ML (0.1MG/ML) 1MG/10ML (0.1MG/ML) 0.5MG/5ML (0.1MG/ML) 0.5MG/5ML (0.1MG/ML) 1MG/10ML (0.1MG/ML) 1MG/10ML (0.1MG/ML) 0.5MG/5ML (0.1MG/ML)

A076955 A076955 A076787 A076787 A076256 A076256 A076755 A076755 A078527 A078527 A078595 A078595 A077071 A077071 A076589 A076589

002 001 002 001 002 001 002 001 001 002 001 002 002 001 002 001

Oct Oct Oct Oct Oct Oct Oct Oct Mar Mar May May May May Oct Oct

12, 12, 12, 12, 12, 12, 12, 12, 23, 23, 13, 13, 03, 03, 12, 12,

2004 2004 2004 2004 2004 2004 2004 2004 2009 2009 2008 2008 2005 2005 2004 2004

N020073 001 N020073 002

Dec 20, 1991 Dec 20, 1991

FLUNISOLIDE

AEROSOL, METERED; INHALATION

AEROBID
0.25MG/INH XX + ROCHE PALO AEROSPAN HFA EQ 78MCG BASE/INH XX + ACTON PHARMS SPRAY, METERED; NASAL FLUNISOLIDE AB + BAUSCH AND LOMB HH AND P AB FLUNISOLIDE XX + APOTEX INC

N018340 001 N021247 001

Aug 17, 1984 Jan 27, 2006

0.025MG/SPRAY 0.025MG/SPRAY 0.029MG/SPRAY

A074805 001 A077704 001 A077436 001

Feb 20, 2002 Aug 03, 2006 Aug 09, 2007

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

FLUOCINOLONE ACETONIDE
CREAM; TOPICAL FLUOCINOLONE ACETONIDE FOUGERA AT AT G AND W LABS AT AT TARO AT SYNALAR AT + MEDIMETRIKS PHARMS AT + AT + IMPLANT; INTRAVITREAL
RETISERT
XX + BAUSCH AND LOMB OIL; TOPICAL DERMA-SMOOTHE/FS AT + HILL DERMAC AT + FLUOCINOLONE ACETONIDE IDENTI PHARMS INC AT AT OIL/DROPS; OTIC DERMOTIC AT + HILL DERMAC FLUOCINOLONE ACETONIDE IDENTI PHARMS INC AT OINTMENT; TOPICAL FLUOCINOLONE ACETONIDE FOUGERA G AND W LABS TARO SYNALAR + MEDIMETRIKS PHARMS

3 - 185 (of 424)

0.01% 0.025% 0.01% 0.025% 0.025% 0.01% 0.025% 0.025%

A088170 A088169 A089526 A089525 A087104

001 001 001 001 001

Dec Dec Jul Jul Apr

16, 16, 26, 26, 27,

1982 1982 1988 1988 1982

N012787 004 N012787 002 N012787 005

0.59MG

N021737 001

Apr 08, 2005

0.01% 0.01% 0.01% 0.01%

N019452 001 N019452 002 A201759 001 A201764 001

Feb 03, 1988 Nov 09, 2005 Oct 17, 2011 Oct 17, 2011

0.01% 0.1%

N019452 003 A091306 001

Nov 09, 2005 Oct 17, 2011

AT AT AT AT

0.025% 0.025% 0.025% 0.025%

A088168 001 A089524 001 A040041 001 N013960 001

Dec 16, 1982 Jul 26, 1988 Sep 15, 1994

SHAMPOO; TOPICAL
CAPEX
XX + GALDERMA LABS LP SOLUTION; TOPICAL FLUOCINOLONE ACETONIDE FOUGERA AT TARO AT SYNALAR AT + MEDIMETRIKS PHARMS

0.01%

N020001 001

Aug 27, 1990

0.01% 0.01% 0.01%

A088167 001 A089124 001 N015296 001

Dec 16, 1982 Sep 11, 1985

FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN

CREAM; TOPICAL
TRI-LUMA
XX + GALDERMA LABS LP

0.01%;4%;0.05%

N021112 001

Jan 18, 2002

FLUOCINONIDE
CREAM; TOPICAL FLUOCINONIDE ACTAVIS MID ATLANTIC AB1 FOUGERA AB1 TARO AB1 TEVA AB1 LIDEX AB1 + MEDICIS

0.05% 0.05% 0.05% 0.05% 0.05%

A073085 A073030 N019117 A072488

001 001 001 001

Feb Oct Jun Feb

14, 17, 26, 06,

1992 1994 1984 1989

N016908 002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

FLUOCINONIDE
CREAM; TOPICAL FLUOCINONIDE EMULSIFIED BASE ALTANA AB2 0.05% TARO AB2 0.05% TEVA AB2 0.05% LIDEX-E AB2 + MEDICIS 0.05% VANOS 0.1% XX + MEDICIS GEL; TOPICAL FLUOCINONIDE FOUGERA TARO TEVA LIDEX + MEDICIS OINTMENT; TOPICAL FLUOCINONIDE ALTANA TARO TEVA LIDEX + MEDICIS SOLUTION; TOPICAL FLUOCINONIDE ACTAVIS MID ATLANTIC FOUGERA TARO TEVA LIDEX + MEDICIS

3 - 186 (of 424)

A076586 001 A072494 001 A072490 001 N016908 003 N021758 001

Jun 23, 2004 Jan 19, 1989 Feb 07, 1989

Feb 11, 2005

AB AB AB AB

0.05% 0.05% 0.05% 0.05%

A072933 001 A074935 001 A072537 001 N017373 001

Dec 30, 1994 Jul 29, 1997 Feb 07, 1989

AB AB AB AB

0.05% 0.05% 0.05% 0.05%

A074905 001 A075008 001 A073481 001 N016909 002

Aug 26, 1997 Jun 30, 1999 Dec 27, 1991

AT AT AT AT AT

0.05% 0.05% 0.05% 0.05% 0.05%

A071535 A072934 A074799 A072511

001 001 001 001

Dec Feb Dec Feb

02, 27, 31, 07,

1988 1995 1996 1989

N018849 001

Apr 06, 1984

FLUORESCEIN SODIUM
INJECTABLE; INTRAVENOUS AK-FLUOR 10% AKORN AP FLUORESCITE AP + ALCON PHARMS LTD

EQ 500MG BASE/5ML (EQ 100MG BASE/ML) EQ 500MG BASE/5ML (EQ 100MG BASE/ML)

N022186 001 N021980 001

Aug 08, 2008 Mar 28, 2006

FLUOROMETHOLONE
OINTMENT; OPHTHALMIC
FML
XX + ALLERGAN

0.1%

N017760 001

Sep 04, 1985

SUSPENSION/DROPS; OPHTHALMIC
FML
0.1% XX + ALLERGAN FML FORTE ALLERGAN 0.25% XX

N016851 002 N019216 001

Jul 28, 1982 Apr 23, 1986

FLUOROMETHOLONE ACETATE
SUSPENSION/DROPS; OPHTHALMIC
FLAREX
XX + ALCON 0.1%

N019079 001

Feb 11, 1986

FLUOROURACIL
CREAM; TOPICAL
EFUDEX
AB + VALEANT PHARM INTL

5%

N016831 003

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

FLUOROURACIL
CREAM; TOPICAL FLUOROURACIL SPEAR PHARMS TARO CARAC + SANOFI AVENTIS US FLUOROPLEX + ALLERGAN HERBERT INJECTABLE; INJECTION FLUOROURACIL + APP PHARMS + + + + BIONICHE PHARMA + + + EBEWE PHARMA SANDOZ + + + TEVA PARENTERAL

3 - 187 (of 424)

AB AB XX XX

5% 5% 0.5% 1%

A077524 001 A090368 001 N020985 001 N016988 001

Apr 11, 2008 Mar 05, 2010 Oct 27, 2000

AP AP AP AP AP AP AP AP AP AP AP AP AP AP

500MG/10ML (50MG/ML) 1GM/20ML (50MG/ML) 2.5GM/50ML (50MG/ML) 5GM/100ML (50MG/ML) 500MG/10ML (50MG/ML) 1GM/20ML (50MG/ML) 2.5GM/50ML (50MG/ML) 5GM/100ML (50MG/ML) 500MG/10ML (50MG/ML) 2.5GM/50ML (50MG/ML) 5GM/100ML (50MG/ML) 500MG/10ML (50MG/ML) 2.5GM/50ML (50MG/ML) 5GM/100ML (50MG/ML)

A040279 A040279 A040278 A040278 A040743 A040743 A040798 A040798 A040772 A091299 A091299 A040333 A040334 A040334

002 001 001 002 002 001 002 001 001 001 002 001 001 002

Sep Sep Sep Sep Apr Apr Apr Apr Aug May May Jan Feb Feb

30, 30, 30, 30, 26, 26, 26, 26, 11, 02, 02, 27, 25, 25,

1998 1998 1998 1998 2007 2007 2007 2007 2008 2011 2011 2000 2000 2000

SOLUTION; TOPICAL EFUDEX AT + VALEANT PHARM INTL AT + FLUOROURACIL TARO AT AT

2% 5% 2% 5%

N016831 001 N016831 002 A076526 001 A076526 002 Nov 05, 2003 Nov 05, 2003

FLUOXETINE HYDROCHLORIDE
CAPSULE; ORAL FLUOXETINE HYDROCHLORIDE ALEMBIC PHARMS LTD AB EQ AUROBINDO PHARMA AB EQ DR REDDYS LABS INC AB EQ IVAX SUB TEVA PHARMS EQ AB MYLAN AB EQ RANBAXY AB EQ SANDOZ AB EQ TEVA AB EQ WOCKHARDT AB EQ PROZAC AB + LILLY EQ FLUOXETINE HYDROCHLORIDE ALEMBIC PHARMS LTD AB1 EQ AB1 EQ ALPHAPHARM AB1 EQ AB1 EQ AUROBINDO PHARMA AB1 EQ AB1 EQ BARR AB1 EQ AB1 EQ BEIJING DOUBLE CRANE EQ AB1 AB1 EQ CARLSBAD AB1 EQ AB1 EQ

40MG 40MG 40MG 40MG 40MG 40MG 40MG 40MG 40MG

BASE BASE BASE BASE BASE BASE BASE BASE BASE

A090223 A078619 A075465 A075245 A075207 A076990 A075049 A075452 A078143

003 003 003 003 003 001 003 003 003

Mar Jan Aug Sep May Dec Jan Jan Jan

19, 31, 02, 28, 25, 13, 29, 29, 16,

2009 2008 2001 2004 2007 2004 2002 2002 2008

40MG BASE 10MG 20MG 10MG 20MG 10MG 20MG 10MG 20MG 10MG 20MG 10MG 20MG BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE

N018936 003 A090223 A090223 A075577 A075577 A078619 A078619 A074803 A074803 A076165 A076165 A076022 A076022 001 002 001 002 001 002 002 001 001 002 001 002

Jun 15, 1999 Mar Mar Jan Jan Jan Jan Jan Aug Feb Feb Jan Jan 19, 19, 29, 29, 31, 31, 30, 02, 01, 01, 30, 30, 2009 2009 2002 2002 2008 2008 2002 2001 2002 2002 2002 2002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

FLUOXETINE HYDROCHLORIDE
CAPSULE; ORAL FLUOXETINE HYDROCHLORIDE DR REDDYS LABS INC AB1 EQ AB1 EQ IVAX SUB TEVA PHARMS EQ AB1 AB1 EQ LANDELA PHARM AB1 EQ AB1 EQ MALLINCKRODT AB1 EQ AB1 EQ MYLAN AB1 EQ AB1 EQ PLIVA AB1 EQ AB1 EQ SANDOZ AB1 EQ AB1 EQ TEVA AB1 EQ AB1 EQ WOCKHARDT AB1 EQ AB1 EQ PROZAC LILLY AB1 EQ AB1 EQ FLUOXETINE HYDROCHLORIDE MYLAN AB2 EQ AB2 EQ SANDOZ AB2 EQ AB2 EQ TEVA AB2 EQ AB2 EQ SARAFEM LILLY AB2 EQ AB2 + EQ

3 - 188 (of 424)

10MG 20MG 10MG 20MG 10MG 20MG 10MG 20MG 10MG 20MG 10MG 20MG 10MG 20MG 10MG 20MG 10MG 20MG

BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE

A075465 A075465 A075245 A075245 A075464 A075464 A075658 A075658 A075207 A075207 A076001 A076001 A075049 A075049 A075452 A075452 A078143 A078143

001 002 002 001 001 002 001 002 001 002 001 002 001 002 001 002 001 002

Jan Jan Jan Jan Jan Jan Jan Jan Jan Jan Jan Jan Aug Jan Jan Jan Jan Jan

29, 29, 31, 31, 30, 30, 29, 29, 30, 30, 29, 29, 02, 29, 29, 29, 16, 16,

2002 2002 2002 2002 2002 2002 2002 2002 2002 2002 2002 2002 2001 2002 2002 2002 2008 2008

10MG BASE 20MG BASE 10MG 20MG 10MG 20MG 10MG 20MG BASE BASE BASE BASE BASE BASE

N018936 006 N018936 001 A078045 A078045 A077469 A077469 A076287 A076287 001 002 001 002 001 002

Dec 23, 1992 Dec 29, 1987 Nov Nov Nov Nov May May 17, 17, 17, 17, 20, 20, 2008 2008 2008 2008 2008 2008

10MG BASE 20MG BASE

N018936 007 N018936 008

Jul 06, 2000 Jul 06, 2000

CAPSULE, DELAYED REL PELLETS; ORAL FLUOXETINE HYDROCHLORIDE BARR EQ 90MG BASE AB DR REDDYS LABS LTD EQ 90MG BASE AB PROZAC WEEKLY AB + LILLY EQ 90MG BASE SOLUTION; ORAL FLUOXETINE HYDROCHLORIDE AUROBINDO PHARM EQ LANNETT EQ MALLINCKRODT EQ NOVEX EQ + PHARM ASSOC EQ SILARX EQ TEVA EQ WOCKHARDT EQ TABLET; ORAL FLUOXETINE HYDROCHLORIDE DR REDDYS LABS INC EQ MYLAN EQ TEVA EQ FLUOXETINE HYDROCHLORIDE EDGEMONT PHARMS LLC EQ + MYLAN EQ SARAFEM WARNER CHILCOTT EQ

A076237 001 A078572 001 N021235 001

Mar 24, 2010 Mar 22, 2010 Feb 26, 2001

AA AA AA AA AA AA AA AA

20MG 20MG 20MG 20MG 20MG 20MG 20MG 20MG

BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML

A079209 A076458 A075920 A075292 A076015 A077849 A075506 A075514

001 001 001 001 001 001 001 001

Mar May Jan Feb Jan Feb Aug Aug

20, 14, 29, 07, 30, 09, 02, 29,

2009 2004 2002 2002 2002 2007 2001 2002

AB AB AB XX XX XX

10MG BASE 10MG BASE 10MG BASE 60MG BASE 20MG BASE 10MG BASE

A076006 001 A075755 001 A075872 001 N202133 001 A075755 002 N021860 001

Jan 30, 2002 Aug 02, 2001 Jan 29, 2002 Oct 06, 2011 Aug 02, 2001 May 19, 2006

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

FLUOXETINE HYDROCHLORIDE
TABLET; ORAL SARAFEM WARNER CHILCOTT XX XX +

3 - 189 (of 424)

EQ 15MG BASE EQ 20MG BASE

N021860 002 N021860 003

May 19, 2006 May 19, 2006

FLUOXETINE HYDROCHLORIDE; OLANZAPINE

CAPSULE; ORAL SYMBYAX LILLY XX XX XX XX + XX

EQ EQ EQ EQ EQ

25MG 25MG 25MG 50MG 50MG

BASE;EQ BASE;EQ BASE;EQ BASE;EQ BASE;EQ

3MG BASE 6MG BASE 12MG BASE 6MG BASE 12MG BASE

N021520 N021520 N021520 N021520 N021520

001 002 004 003 005

Apr Dec Dec Dec Dec

09, 24, 24, 24, 24,

2007 2003 2003 2003 2003

FLUOXYMESTERONE

TABLET; ORAL

FLUOXYMESTERONE
XX + USL PHARMA

10MG

A088342 001

Oct 21, 1983

FLUPHENAZINE DECANOATE
INJECTABLE; INJECTION FLUPHENAZINE DECANOATE AO + APP PHARMS BEDFORD AO CLARIS LIFESCIENCES AO

25MG/ML 25MG/ML 25MG/ML

A071413 001 A074531 001 A075918 001

Jul 14, 1987 Aug 30, 1996 Aug 17, 2001

FLUPHENAZINE HYDROCHLORIDE

CONCENTRATE; ORAL

FLUPHENAZINE HYDROCHLORIDE
5MG/ML XX + PHARM ASSOC
ELIXIR; ORAL

FLUPHENAZINE HYDROCHLORIDE
2.5MG/5ML XX + PHARM ASSOC
INJECTABLE; INJECTION

FLUPHENAZINE HYDROCHLORIDE
2.5MG/ML XX + APP PHARMS TABLET; ORAL FLUPHENAZINE HYDROCHLORIDE LANNETT AB 1MG AB 2.5MG AB 5MG AB 10MG MYLAN AB 1MG AB 2.5MG AB 5MG AB + 10MG SANDOZ AB 1MG AB 2.5MG AB 5MG AB 10MG

A074725 001

Sep 16, 1996

A040146 001

Aug 21, 1996

A089556 001

Apr 16, 1987

A089740 A089741 A089742 A089743 A089804 A089804 A089804 A089804 A089583 A089584 A089585 A089586

001 001 001 001 002 003 004 001 001 001 001 001

Aug Aug Aug Aug Aug Aug Aug Aug Oct Oct Oct Oct

25, 25, 25, 25, 12, 12, 12, 12, 16, 16, 16, 16,

1988 1988 1988 1988 1988 1988 1988 1988 1987 1987 1987 1987

FLURANDRENOLIDE
CREAM; TOPICAL CORDRAN SP WATSON PHARMS XX

0.025%

N012806 003

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

FLURANDRENOLIDE

LOTION; TOPICAL

CORDRAN
XX + WATSON LABS
TAPE; TOPICAL

CORDRAN
XX + WATSON PHARMS

3 - 190 (of 424)

0.05%

N013790 001

0.004MG/SQ CM

N016455 001

FLURAZEPAM HYDROCHLORIDE
CAPSULE; ORAL FLURAZEPAM HYDROCHLORIDE MYLAN PHARMS INC 15MG + 30MG WATSON LABS 15MG 30MG 30MG WEST WARD 15MG 30MG

AB AB AB AB AB AB AB

A070345 A070345 A071205 A071068 A072369 A071107 A071108

002 001 001 001 001 001 001

Nov Nov Nov Nov Mar Dec Dec

27, 27, 25, 25, 30, 08, 08,

1985 1985 1986 1986 1989 1986 1986

FLURBIPROFEN
TABLET; ORAL ANSAID PHARMACIA AND UPJOHN AB AB + FLURBIPROFEN CARACO AB AB MYLAN AB AB TEVA AB

50MG 100MG 50MG 100MG 50MG 100MG 100MG

N018766 002 N018766 003 A075058 A075058 A074358 A074358 A074431 001 002 001 002 001

Oct 31, 1988 Oct 31, 1988 Apr Apr Jun Jun May 27, 27, 20, 20, 31, 2001 2001 1994 1994 1995

FLURBIPROFEN SODIUM
SOLUTION/DROPS; OPHTHALMIC FLURBIPROFEN SODIUM BAUSCH AND LOMB AT 0.03% OCUFEN AT + ALLERGAN 0.03%

A074447 001 N019404 001

Jan 04, 1995 Dec 31, 1986

FLUTAMIDE
CAPSULE; ORAL FLUTAMIDE IVAX SUB TEVA PHARMS MYLAN PAR PHARM + SANDOZ WATSON LABS

AB AB AB AB AB

125MG 125MG 125MG 125MG 125MG

A075780 A076224 A075298 A075818 A075820

001 001 001 001 001

Sep May Sep Sep Sep

19, 09, 18, 18, 18,

2001 2003 2001 2001 2001

FLUTICASONE FUROATE

SPRAY, METERED; NASAL

VERAMYST
XX + GLAXOSMITHKLINE

0.0275MG/INH

N022051 001

Apr 27, 2007

FLUTICASONE PROPIONATE
AEROSOL, METERED; INHALATION FLOVENT HFA 0.044MG/INH XX + GLAXO GRP LTD 0.11MG/INH XX + 0.22MG/INH XX +

N021433 003 N021433 002 N021433 001

May 14, 2004 May 14, 2004 May 14, 2004

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

FLUTICASONE PROPIONATE
CREAM; TOPICAL CUTIVATE + ALTANA FLUTICASONE PROPIONATE ALTANA G AND W LABS NESHER PHARMS PERRIGO NEW YORK TOLMAR

3 - 191 (of 424)

AB AB AB AB AB AB

0.05% 0.05% 0.05% 0.05% 0.05% 0.05%

N019958 001 A076451 A077055 A076865 A076793 A076633 001 001 001 001 001

Dec 18, 1990 May Jun Sep May May 14, 30, 10, 14, 14, 2004 2006 2004 2004 2004

LOTION; TOPICAL CUTIVATE AB + FOUGERA PHARMS FLUTICASONE PROPIONATE GLENMARK GENERICS AB OINTMENT; TOPICAL CUTIVATE + FOUGERA PHARMS FLUTICASONE PROPIONATE ALTANA G AND W LABS PERRIGO NEW YORK

0.05% 0.05%

N021152 001 A090759 001

Mar 31, 2005 May 02, 2011

AB AB AB AB

0.005% 0.005% 0.005% 0.005%

N019957 001 A076300 001 A077168 001 A076668 001

Dec 14, 1990 May 14, 2004 Mar 03, 2006 May 14, 2004

POWDER; INHALATION
FLOVENT DISKUS 100
XX + GLAXOSMITHKLINE FLOVENT DISKUS 250 XX + GLAXOSMITHKLINE FLOVENT DISKUS 50 XX + GLAXOSMITHKLINE SPRAY, METERED; NASAL FLONASE + GLAXOSMITHKLINE FLUTICASONE PROPIONATE APOTEX INC HI TECH PHARMA ROXANE WOCKHARDT

0.1MG/INH 0.25MG/INH 0.05MG/INH

N020833 002 N020833 003 N020833 001

Sep 29, 2000 Sep 29, 2000 Sep 29, 2000

AB AB AB AB AB

0.05MG/SPRAY 0.05MG/SPRAY 0.05MG/SPRAY 0.05MG/SPRAY 0.05MG/SPRAY

N020121 001 A077538 A077570 A076504 A078492 001 001 001 001

Oct 19, 1994 Sep Jan Feb Jan 12, 16, 22, 09, 2007 2008 2006 2012

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

AEROSOL, METERED; INHALATION
ADVAIR HFA
0.045MG/INH;EQ 0.021MG BASE/INH XX + GLAXOSMITHKLINE 0.115MG/INH;EQ 0.021MG BASE/INH XX + 0.23MG/INH;EQ 0.021MG BASE/INH XX + POWDER; INHALATION
ADVAIR DISKUS 100/50
XX + GLAXOSMITHKLINE ADVAIR DISKUS 250/50 XX + GLAXOSMITHKLINE ADVAIR DISKUS 500/50 XX + GLAXOSMITHKLINE

N021254 001 N021254 002 N021254 003

Jun 08, 2006 Jun 08, 2006 Jun 08, 2006

0.1MG/INH;EQ 0.05MG BASE/INH 0.25MG/INH;EQ 0.05MG BASE/INH 0.5MG/INH;EQ 0.05MG BASE/INH

N021077 001 N021077 002 N021077 003

Aug 24, 2000 Aug 24, 2000 Aug 24, 2000

FLUVASTATIN SODIUM
CAPSULE; ORAL
LESCOL
NOVARTIS
XX XX +

EQ 20MG BASE EQ 40MG BASE

N020261 001 N020261 002

Dec 31, 1993 Dec 31, 1993

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

FLUVASTATIN SODIUM
TABLET, EXTENDED RELEASE; ORAL
LESCOL XL
80MG XX + NOVARTIS

3 - 192 (of 424)

N021192 001

Oct 06, 2000

FLUVOXAMINE MALEATE
CAPSULE, EXTENDED RELEASE; ORAL LUVOX CR JAZZ 100MG XX 150MG XX + TABLET; ORAL FLUVOXAMINE MALEATE APOTEX AB AB AB BARR AB AB AB CARACO AB AB AB MYLAN AB AB AB SANDOZ AB AB AB + TEVA AB AB AB LUVOX ANI PHARMS AB AB AB

N022033 001 N022033 002

Feb 28, 2008 Feb 28, 2008

25MG 50MG 100MG 25MG 50MG 100MG 25MG 50MG 100MG 25MG 50MG 100MG 25MG 50MG 100MG 25MG 50MG 100MG 25MG 50MG 100MG

A075902 A075902 A075902 A075897 A075897 A075897 A075900 A075900 A075900 A075889 A075889 A075889 A075888 A075888 A075888 A075893 A075893 A075893

001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003

May May May Jan Jan Jan Feb Feb Feb Nov Nov Nov Nov Nov Nov Sep Sep Sep

07, 07, 07, 25, 25, 25, 23, 23, 23, 29, 29, 29, 29, 29, 29, 10, 10, 10,

2001 2001 2001 2001 2001 2001 2006 2006 2006 2000 2000 2000 2000 2000 2000 2002 2002 2002

N021519 001 N021519 002 N021519 003

Dec 20, 2007 Dec 20, 2007 Dec 20, 2007

FOLIC ACID
INJECTABLE; INJECTION
FOLIC ACID
XX + APP PHARMS TABLET; ORAL FOLIC ACID + AMNEAL PHARM CONTRACT PHARMACAL EXCELLIUM INVAGEN PHARMS JUBILANT CADISTA VINTAGE + WATSON LABS WEST WARD

5MG/ML

A089202 001

Feb 18, 1986

AA AA AA AA AA AA AA AA

1MG 1MG 1MG 1MG 1MG 1MG 1MG 1MG

A040625 A085061 A040796 A090035 A040514 A040756 A080680 A080600

001 001 001 001 001 001 001 001

Jul 21, 2005 Jan Jun Jun Jun 12, 09, 14, 04, 2009 2009 2005 2010

FOLLITROPIN ALFA/BETA
INJECTABLE; SUBCUTANEOUS FOLLISTIM AQ + ORGANON USA INC + + + +

XX XX XX XX XX

75 IU/0.5ML 150 IU/0.5ML 300 IU/0.36ML 600 IU/0.72ML 900 IU/1.08ML

N021273 N021273 N021211 N021211 N021211

001 002 001 002 004

Aug Aug Mar Mar Feb

26, 26, 23, 23, 11,

2005 2005 2004 2004 2005

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

FOLLITROPIN ALFA/BETA

INJECTABLE; SUBCUTANEOUS

GONAL-F
XX + EMD SERONO XX GONAL-F RFF XX + EMD SERONO GONAL-F RFF PEN XX + EMD SERONO XX + XX +

3 - 193 (of 424)

450 IU/VIAL 1,050 IU/VIAL 75 IU/VIAL 300 IU/0.5ML 450 IU/0.75ML 900 IU/1.5ML

N020378 005 N020378 004 N021765 002 N021684 001 N021684 002 N021684 003

Mar 26, 2004 Feb 28, 2001 Mar 25, 2004 May 25, 2004 May 25, 2004 May 25, 2004

FOMEPIZOLE
INJECTABLE; INJECTION ANTIZOL + PALADIN LABS FOMEPIZOLE BIONICHE PHARMA USA LUITPOLD NAVINTA LLC SYNERX PHARMA

AP AP AP AP AP

1.5GM/1.5ML (1GM/ML) 1.5GM/1.5ML 1.5GM/1.5ML 1.5GM/1.5ML 1.5GM/1.5ML (1GM/ML) (1GM/ML) (1GM/ML) (1GM/ML)

N020696 001 A079033 A078368 A078537 A078639 001 001 001 001

Dec 04, 1997 Apr Dec Mar Mar 07, 14, 06, 03, 2009 2007 2008 2008

FONDAPARINUX SODIUM
INJECTABLE; SUBCUTANEOUS ARIXTRA + GLAXOSMITHKLINE + + + FONDAPARINUX SODIUM DR REDDYS LABS LTD

AP AP AP AP AP AP AP AP

2.5MG/0.5ML 5MG/0.4ML 7.5MG/0.6ML 10MG/0.8ML 2.5MG/0.5ML 5MG/0.4ML 7.5MG/0.6ML 10MG/0.8ML

N021345 N021345 N021345 N021345 A091316 A091316 A091316 A091316

001 002 003 004 001 002 003 004

Dec May May May Jul Jul Jul Jul

07, 28, 28, 28, 11, 11, 11, 11,

2001 2004 2004 2004 2011 2011 2011 2011

FORMOTEROL FUMARATE

POWDER; INHALATION

FORADIL
XX + NOVARTIS
SOLUTION; INHALATION

PERFOROMIST
XX + DEY PHARMA

0.012MG/INH

N020831 001

Feb 16, 2001

0.02MG/2ML

N022007 001

May 11, 2007

FORMOTEROL FUMARATE; MOMETASONE FUROATE

AEROSOL, METERED; INHALATION

DULERA
0.005MG/INH;0.1MG/INH XX + SCHERING 0.005MG/INH;0.2MG/INH XX +

N022518 001 N022518 002

Jun 22, 2010 Jun 22, 2010

FOSAMPRENAVIR CALCIUM

SUSPENSION; ORAL

LEXIVA
XX + VIIV HLTHCARE
TABLET; ORAL

LEXIVA
XX + VIIV HLTHCARE

EQ 50MG BASE/ML

N022116 001

Jun 14, 2007

EQ 700MG BASE

N021548 001

Oct 20, 2003

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

FOSAPREPITANT DIMEGLUMINE
POWDER; INTRAVENOUS

EMEND

XX + MERCK AND CO INC XX +

3 - 194 (of 424)

EQ 115MG BASE/VIAL EQ 150MG BASE/VIAL

N022023 001 N022023 002

Jan 25, 2008 Nov 12, 2010

FOSCARNET SODIUM
INJECTABLE; INJECTION FOSCARNET SODIUM HOSPIRA AP FOSCAVIR AP + CLINIGEN HLTHCARE

2.4GM/100ML 2.4GM/100ML

A077174 001 N020068 001

May 31, 2005 Sep 27, 1991

FOSFOMYCIN TROMETHAMINE

FOR SUSPENSION; ORAL

MONUROL
XX + ZAMBON SPA

EQ 3GM BASE/PACKET

N050717 001

Dec 19, 1996

FOSINOPRIL SODIUM
TABLET; ORAL FOSINOPRIL SODIUM APOTEX INC AB AB AB AUROBINDO PHARMA LTD AB AB AB INVAGEN PHARMS AB AB AB RANBAXY AB AB AB SANDOZ AB AB AB TEVA AB AB AB + WATSON LABS AB AB AB AB AB AB WATSON LABS FLORIDA AB AB AB MONOPRIL BRISTOL MYERS SQUIBB AB AB AB +

10MG 20MG 40MG 10MG 20MG 40MG 10MG 20MG 40MG 10MG 20MG 40MG 10MG 20MG 40MG 10MG 20MG 40MG 10MG 10MG 20MG 20MG 40MG 40MG 10MG 20MG 40MG 10MG 20MG 40MG

A076906 A076906 A076906 A091163 A091163 A091163 A077222 A077222 A077222 A076580 A076580 A076580 A076483 A076483 A076483 A076139 A076139 A076139 A076987 A077531 A076987 A077531 A076987 A077531 A076620 A076620 A076620

001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 001 001 002 002 003 003 001 002 003

May May May Mar Mar Mar Apr Apr Apr Apr Apr Apr Apr Apr Apr Nov Nov Nov Dec Aug Dec Aug Dec Aug Oct Oct Oct

17, 17, 17, 30, 30, 30, 20, 20, 20, 23, 23, 23, 23, 23, 23, 25, 25, 25, 23, 31, 23, 31, 23, 31, 15, 15, 15,

2005 2005 2005 2011 2011 2011 2005 2005 2005 2004 2004 2004 2004 2004 2004 2003 2003 2003 2004 2006 2004 2006 2004 2006 2004 2004 2004

N019915 002 N019915 003 N019915 004

May 16, 1991 May 16, 1991 Mar 28, 1995

FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE

TABLET; ORAL FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE AUROBINDO PHARMA 10MG;12.5MG AB 20MG;12.5MG AB INVAGEN PHARMS 10MG;12.5MG AB 20MG;12.5MG AB

A079245 A079245 A090228 A090228

001 002 001 002

Jul Jul Jul Jul

09, 09, 09, 09,

2009 2009 2009 2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE
TABLET; ORAL FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE MYLAN 10MG;12.5MG AB 20MG;12.5MG AB RANBAXY 10MG;12.5MG AB 20MG;12.5MG AB SANDOZ 10MG;12.5MG AB 20MG;12.5MG AB WATSON LABS FLORIDA 10MG;12.5MG AB 20MG;12.5MG AB

3 - 195 (of 424)

A077705 A077705 A076739 A076739 A076961 A076961 A076608 A076608

001 002 001 002 001 002 001 002

Aug Aug Dec Dec Sep Sep Dec Dec

14, 14, 17, 17, 28, 28, 03, 03,

2006 2006 2004 2004 2005 2005 2004 2004

FOSINOPRIL; HYDROCHLOROTHIAZIDE
TABLET; ORAL FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE EMCURE PHARMS USA AB 10MG;12.5MG AB 20MG;12.5MG

A079025 001 A079025 002

Sep 17, 2010 Sep 17, 2010

FOSPHENYTOIN SODIUM
INJECTABLE; INJECTION FOSPHENYTOIN SODIUM APOTEX INC + APP PHARMS BAXTER HLTHCARE BEDFORD HIKMA FARMACEUTICA HOSPIRA LUITPOLD PFIZER STRIDES ARCOLAB SUN PHARMA GLOBAL TEVA PARENTERAL WOCKHARDT

AP AP AP AP AP AP AP AP AP AP AP AP AP

EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ

50MG 50MG 50MG 50MG 50MG 50MG 50MG 50MG 50MG 50MG 50MG 50MG 50MG

PHENYTOIN PHENYTOIN PHENYTOIN PHENYTOIN PHENYTOIN PHENYTOIN PHENYTOIN PHENYTOIN PNENYTOIN PHENYTOIN PHENYTOIN PHENYTOIN PHENYTOIN

NA/ML NA/ML NA/ML NA/ML NA/ML NA/ML NA/ML NA/ML NA/ML NA/ML NA/ML NA/ML NA/ML

A078126 A078052 A077989 A077481 A078765 A078158 A078277 A090099 A078476 A078736 A078417 A076886 A078137

001 001 001 001 001 001 001 001 001 001 001 001 001

Aug Aug Aug Aug Dec Aug Aug May Mar Jun Mar Aug Aug

06, 06, 06, 06, 02, 06, 06, 13, 18, 08, 18, 06, 06,

2007 2007 2007 2007 2009 2007 2007 2010 2008 2010 2008 2007 2007

FOSPROPOFOL DISODIUM
SOLUTION; INTRAVENOUS
LUSEDRA
XX + EISAI INC

1050MG/30ML (35MG/ML)

N022244 001

Dec 12, 2008

FROVATRIPTAN SUCCINATE
TABLET; ORAL
FROVA
XX + ENDO PHARMS

EQ 2.5MG BASE

N021006 001

Nov 08, 2001

FULVESTRANT
INJECTABLE; INTRAMUSCULAR
FASLODEX
50MG/ML XX + ASTRAZENECA

N021344 001

Apr 25, 2002

FUROSEMIDE
INJECTABLE; INJECTION FUROSEMIDE APP PHARMS AP HOSPIRA AP AP AP INTL MEDICATION AP AP + LUITPOLD

10MG/ML 10MG/ML 10MG/ML 10MG/ML 10MG/ML 10MG/ML

N018902 A070578 A075241 N018667 N018025 N018579

001 001 001 001 001 001

May Jul May May

22, 08, 28, 28,

1984 1987 1999 1982

Nov 30, 1983

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

FUROSEMIDE
INJECTABLE; INJECTION FUROSEMIDE WOCKHARDT AP SOLUTION; ORAL FUROSEMIDE AA + ROXANE WOCKHARDT AA FUROSEMIDE ROXANE XX TABLET; ORAL FUROSEMIDE DAVA PHARMS INC AB AB AB EXCELLIUM AB AB AB IPCA LABS LTD AB AB AB IVAX SUB TEVA PHARMS AB AB MYLAN AB AB AB ROXANE AB AB AB SANDOZ AB AB AB VINTAGE PHARMS AB AB AB WATSON LABS AB AB AB AB AB AB LASIX SANOFI AVENTIS US AB AB AB +

3 - 196 (of 424)

10MG/ML

A077941 001

Mar 22, 2007

10MG/ML 10MG/ML 40MG/5ML

A070434 001 A070655 001 A070433 001

Apr 22, 1987 Oct 02, 1987 Apr 22, 1987

20MG 40MG 80MG 20MG 40MG 80MG 20MG 40MG 80MG 20MG 40MG 20MG 40MG 80MG 20MG 40MG 80MG 20MG 40MG 80MG 20MG 40MG 80MG 20MG 20MG 20MG 40MG 80MG 80MG 20MG 40MG 80MG

N018415 N018415 N018415 A077293 A077293 A077293 A078010 A078010 A078010 N018413 N018413 N018487 N018487 A070082 N018823 N018823 A070086 N018569 N018569 N018569 A076796 A076796 A076796 A070412 A070449 A071379 A070450 A070528 A071594

001 002 003 001 002 003 001 002 003 001 002 001 002 001 001 002 001 002 001 005 001 002 003 001 001 001 001 001 001

Jul Jul Nov Nov Nov Nov Sep Sep Sep Nov Nov

27, 27, 26, 09, 09, 09, 18, 18, 18, 30, 30,

1982 1982 1984 2005 2005 2005 2006 2006 2006 1983 1983

Oct Nov Nov Jan

29, 10, 10, 24,

1986 1983 1983 1986

Aug Mar Mar Mar Feb Nov Jan Nov Jan Feb

14, 26, 26, 26, 26, 22, 02, 22, 07, 09,

1984 2004 2004 2004 1986 1985 1987 1985 1986 1988

N016273 002 N016273 001 N016273 003

GABAPENTIN
CAPSULE; ORAL GABAPENTIN ACTAVIS ELIZABETH AB AB AB ALKEM AB AB AB AMNEAL PHARMS NY AB AB AB APOTEX INC AB AB

100MG 300MG 400MG 100MG 300MG 400MG 100MG 300MG 400MG 100MG 300MG

A075350 A075350 A075350 A090858 A090858 A090858 A078428 A078428 A078428 A075360 A075360

001 002 003 001 002 003 001 002 003 001 002

Sep Sep Sep Dec Dec Dec Jul Jul Jul Apr Apr

12, 12, 12, 17, 17, 17, 25, 25, 25, 06, 06,

2003 2003 2003 2010 2010 2010 2007 2007 2007 2005 2005

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

GABAPENTIN
CAPSULE; ORAL GABAPENTIN APOTEX INC AB AUROBINDO PHARM AB AB AB HIKMA AB AB AB INVAGEN PHARMS AB AB AB MARKSANS PHARMA AB AB AB MYLAN AB AB AB RANBAXY AB AB AB SUN PHARM INDS LTD AB AB AB TEVA PHARMS AB AB AB WATSON LABS AB AB AB NEURONTIN PFIZER PHARMS AB AB AB + SOLUTION; ORAL GABAPENTIN HI TECH PHARMA AA NEURONTIN AA + PARKE DAVIS TABLET; ORAL GABAPENTIN ACTAVIS ELIZABETH AB AB APOTEX INC AB AB AB AB AB AUROBINDO PHARMA LTD AB AB GLENMARK GENERICS AB AB HIKMA PHARMS AB AB IVAX SUB TEVA PHARMS AB AB AB AB AB

3 - 197 (of 424)

400MG 100MG 300MG 400MG 100MG 300MG 400MG 100MG 300MG 400MG 100MG 300MG 400MG 100MG 300MG 400MG 100MG 300MG 400MG 100MG 300MG 400MG 100MG 300MG 400MG 100MG 300MG 400MG 100MG 300MG 400MG

A075360 A078787 A078787 A078787 A078150 A078150 A078150 A090705 A090705 A090705 A090007 A090007 A090007 A090158 A090158 A090158 A076606 A076606 A076606 A077242 A077242 A077242 A075435 A075435 A075435 A075485 A075485 A075485

003 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 003 002 001

Apr Jan Jan Jan Sep Sep Sep Dec Dec Dec Jul Jul Jul Feb Feb Feb Oct Oct Oct Aug Aug Aug Oct Oct Oct May May May

06, 31, 31, 31, 25, 25, 25, 30, 30, 30, 21, 21, 21, 14, 14, 14, 07, 07, 07, 24, 24, 24, 08, 08, 08, 11, 11, 11,

2005 2008 2008 2008 2007 2007 2007 2009 2009 2009 2011 2011 2011 2011 2011 2011 2005 2005 2005 2006 2006 2006 2004 2004 2004 2007 2007 2007

N020235 001 N020235 002 N020235 003

Dec 30, 1993 Dec 30, 1993 Dec 30, 1993

250MG/5ML 250MG/5ML

A078974 001 N021129 001

Feb 18, 2011 Mar 02, 2000

600MG 800MG 100MG 300MG 400MG 600MG 800MG 600MG 800MG 600MG 800MG 600MG 800MG 100MG 300MG 400MG 600MG 800MG

A075694 A075694 A077894 A077894 A077894 A077661 A077661 A200651 A200651 A077662 A077662 A078782 A078782 A076017 A076017 A076017 A076017 A076017

001 002 001 002 003 004 005 001 002 001 002 001 002 001 002 003 004 005

Oct Oct Oct Oct Oct Sep Sep Oct Oct Aug Aug Jul Jul Apr Apr Apr Apr Apr

21, 21, 10, 10, 10, 13, 13, 06, 06, 18, 18, 21, 21, 28, 28, 28, 29, 29,

2004 2004 2006 2006 2006 2006 2006 2011 2011 2006 2006 2011 2011 2004 2004 2004 2005 2005

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

GABAPENTIN
TABLET; ORAL GABAPENTIN MATRIX LABS LTD AB AB SUN PHARM INDS LTD AB AB ZYDUS PHARMS USA INC AB AB NEURONTIN PFIZER PHARMS AB AB + GRALISE BX + DEPOMED INC BX +

3 - 198 (of 424)

600MG 800MG 600MG 800MG 600MG 800MG 600MG 800MG 300MG 600MG

A090335 A090335 A077525 A077525 A078926 A078926

001 002 001 002 001 002

Jun Jun Aug Aug Feb Feb

01, 01, 24, 24, 11, 11,

2010 2010 2006 2006 2011 2011

N020882 001 N020882 002 N022544 001 N022544 002

Oct 09, 1998 Oct 09, 1998 Jan 28, 2011 Jan 28, 2011

GABAPENTIN ENACARBIL
TABLET, EXTENDED RELEASE; ORAL
HORIZANT
XX GLAXO GRP LTD 300MG
XX + 600MG

N022399 002 N022399 001

Dec 13, 2011 Apr 06, 2011

GADOBENATE DIMEGLUMINE

INJECTABLE; INTRAVENOUS

MULTIHANCE
+ BRACCO + + + MULTIHANCE MULTIPACK + BRACCO +

XX XX XX XX XX XX

2.645GM/5ML (529MG/ML) 5.29GM/10ML (529MG/ML) 7.935GM/15ML (529MG/ML) 10.58GM/20ML (529MG/ML) 26.45GM/50ML (529MG/ML) 52.9GM/100ML (529MG/ML)

N021357 N021357 N021357 N021357

001 002 003 004

Nov Nov Nov Nov

23, 23, 23, 23,

2004 2004 2004 2004

N021358 001 N021358 002

Nov 23, 2004 Nov 23, 2004

GADOBUTROL

SOLUTION; INTRAVENOUS

GADAVIST
+ BAYER HLTHCARE + + + +

XX XX XX XX XX

4.5354GM/7.5ML (604.72MG/ML) 6.0472GM/10ML (604.72MG/ML) 9.0708GM/15ML (604.72MG/ML) 18.1416GM/30ML (604.72MG/ML) 39.3068GM/65ML (604.72MG/ML)

N201277 N201277 N201277 N201277 N201277

001 002 003 004 005

Mar Mar Mar Mar Mar

14, 14, 14, 14, 14,

2011 2011 2011 2011 2011

GADODIAMIDE

INJECTABLE; INJECTION

OMNISCAN
XX + GE HEALTHCARE XX +

287MG/ML 28.7GM/100ML (287MG/ML)

N020123 001 N022066 002

Jan 08, 1993 Sep 05, 2007

GADOFOSVESET TRISODIUM
SOLUTION; INTRAVENOUS
ABLAVAR
LANTHEUS MEDCL XX XX +

2440MG/10ML (244MG/ML)
3660MG/15ML (244MG/ML)

N021711 001 N021711 002

Dec 22, 2008

Dec 22, 2008

GADOPENTETATE DIMEGLUMINE

INJECTABLE; INJECTION

MAGNEVIST
XX + BAYER HLTHCARE XX +

469.01MG/ML 469.01MG/ML

N019596 001 N021037 001

Jun 02, 1988

Mar 10, 2000

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

GADOTERIDOL
INJECTABLE; INJECTION

PROHANCE

XX + BRACCO PROHANCE MULTIPACK XX + BRACCO

3 - 199 (of 424)

279.3MG/ML 279.3MG/ML

N020131 001 N021489 001

Nov 16, 1992 Oct 09, 2003

GADOVERSETAMIDE

INJECTABLE; INJECTION

OPTIMARK
+ MALLINCKRODT 1654.5MG/5ML (330.9MG/ML) + 3309MG/10ML (330.9MG/ML) + 4963.5MG/15ML (330.9MG/ML) + 6618MG/20ML (330.9MG/ML) + 16.545GM/50ML (330.9MG/ML) OPTIMARK IN PLASTIC CONTAINER + MALLINCKRODT 3309MG/10ML (330.9MG/ML) + 4963.5MG/15ML (330.9MG/ML) + 6618MG/20ML (330.9MG/ML) + 9927MG/30ML (330.9MG/ML)

XX XX XX XX XX XX XX XX XX

N020937 N020937 N020937 N020937 N020975 N020976 N020976 N020976 N020976

001 002 003 004 001 002 003 004 001

Dec Dec Dec Dec Dec Dec Dec Dec Dec

08, 08, 08, 08, 08, 08, 08, 08, 08,

1999 1999 1999 1999 1999 1999 1999 1999 1999

GADOXETATE DISODIUM

SOLUTION; INTRAVENOUS

EOVIST
XX + BAYER HLTHCARE

1.8143GM/10ML (181.43MG/ML)

N022090 001

Jul 03, 2008

GALANTAMINE HYDROBROMIDE
CAPSULE, EXTENDED RELEASE; ORAL GALANTAMINE HYDROBROMIDE BARR EQ 8MG BASE EQ 16MG BASE EQ 24MG BASE IMPAX LABS EQ 8MG BASE EQ 16MG BASE EQ 24MG BASE MYLAN EQ 8MG BASE EQ 16MG BASE EQ 24MG BASE SUN PHARMA GLOBAL EQ 8MG BASE EQ 16MG BASE EQ 24MG BASE WATSON LABS EQ 8MG BASE EQ 16MG BASE EQ 24MG BASE RAZADYNE ER + JANSSEN PHARMS EQ 8MG BASE EQ 16MG BASE EQ 24MG BASE

AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB

A078189 A078189 A078189 A078484 A078484 A078484 A090900 A090900 A090900 A090178 A090178 A090178 A079028 A079028 A079028

001 002 003 001 002 003 001 002 003 001 002 003 001 002 003

Sep Sep Sep May May May Jan Jan Jan Feb Feb Feb Dec Dec Dec

15, 15, 15, 27, 27, 27, 24, 24, 24, 02, 02, 02, 15, 15, 15,

2008 2008 2008 2009 2009 2009 2011 2011 2011 2011 2011 2011 2008 2008 2008

N021615 001 N021615 002 N021615 003

Apr 01, 2005 Apr 01, 2005 Apr 01, 2005

SOLUTION; ORAL GALANTAMINE HYDROBROMIDE ROXANE AA 4MG/ML RAZADYNE AA + JANSSEN PHARMS 4MG/ML TABLET; ORAL GALANTAMINE HYDROBROMIDE APOTEX INC EQ EQ EQ AUROBINDO PHARMA LTD EQ

A078185 001 N021224 001

Jan 30, 2009 Jun 22, 2001

AB AB AB AB

4MG BASE 8MG BASE 12MG BASE 4MG BASE

A077781 A077781 A077781 A090957

001 002 003 001

Sep Sep Sep Mar

27, 27, 27, 29,

2011 2011 2011 2011

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

GALANTAMINE HYDROBROMIDE
TABLET; ORAL GALANTAMINE HYDROBROMIDE AUROBINDO PHARMA LTD EQ AB AB EQ BARR AB EQ AB EQ AB EQ DR REDDYS LABS LTD AB EQ AB EQ AB EQ MYLAN AB EQ AB EQ AB EQ AB EQ AB EQ AB EQ ROXANE AB EQ AB EQ AB EQ SANDOZ AB EQ AB EQ AB EQ TEVA PHARMS AB EQ AB EQ AB EQ ZYDUS PHARMS USA INC EQ AB AB EQ AB EQ RAZADYNE AB + JANSSEN PHARMS EQ AB EQ AB EQ

3 - 200 (of 424)

8MG BASE 12MG BASE 4MG BASE 8MG BASE 12MG BASE 4MG BASE 8MG BASE 12MG BASE 4MG BASE 4MG BASE 8MG BASE 8MG BASE 12MG BASE 12MG BASE 4MG BASE 8MG BASE 12MG BASE 4MG BASE 8MG BASE 12MG BASE 4MG BASE 8MG BASE 12MG BASE 4MG BASE 8MG BASE 12MG BASE 4MG BASE 8MG BASE 12MG BASE

A090957 A090957 A077605 A077605 A077605 A077593 A077593 A077593 A077590 A077603 A077590 A077603 A077590 A077603 A077608 A077608 A077608 A077589 A077589 A077589 A077587 A077587 A077587 A078898 A078898 A078898

002 003 001 002 003 001 002 003 001 001 002 002 003 003 001 002 003 001 002 003 001 002 003 001 002 003

Mar Mar Aug Aug Aug Sep Sep Sep May Aug May Aug May Aug Feb Feb Feb Jun Jun Jun Jul Jul Jul Feb Feb Feb

29, 29, 28, 28, 28, 11, 11, 11, 29, 28, 29, 28, 29, 28, 11, 11, 11, 22, 22, 22, 09, 09, 09, 17, 17, 17,

2011 2011 2008 2008 2008 2008 2008 2008 2009 2008 2009 2008 2009 2008 2009 2009 2009 2009 2009 2009 2009 2009 2009 2011 2011 2011

N021169 001 N021169 002 N021169 003

Feb 28, 2001 Feb 28, 2001 Feb 28, 2001

GALLIUM CITRATE GA-67

INJECTABLE; INJECTION GALLIUM CITRATE GA 67 BS LANTHEUS MEDCL BS MALLINCKRODT

2mCi/ML 2mCi/ML

N017478 001 N018058 001

GALLIUM NITRATE

INJECTABLE; INJECTION

GANITE
XX + GENTA

25MG/ML

N019961 002

Jan 17, 1991

GANCICLOVIR
CAPSULE; ORAL GANCICLOVIR RANBAXY XX XX + GEL; OPHTHALMIC

ZIRGAN

XX + BAUSCH AND LOMB IMPLANT; IMPLANTATION

VITRASERT

XX + BAUSCH AND LOMB

250MG 500MG

A076457 001 A076457 002

Jun 27, 2003 Jun 27, 2003

0.15%

N022211 001

Sep 15, 2009

4.5MG

N020569 001

Mar 04, 1996

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

GANCICLOVIR SODIUM
INJECTABLE; INJECTION CYTOVENE AP + ROCHE PALO GANCICLOVIR APP PHARMS AP

3 - 201 (of 424)

EQ 500MG BASE/VIAL EQ 500MG BASE/VIAL

N019661 001 A090658 001

Jun 23, 1989 Jun 21, 2010

GANIRELIX ACETATE
INJECTABLE; INJECTION

GANIRELIX ACETATE INJECTION

EQ 250MCG BASE/0.5ML XX + ORGANON USA INC

N021057 001

Jul 29, 1999

GATIFLOXACIN
SOLUTION/DROPS; OPHTHALMIC GATIFLOXACIN APOTEX CORP AT 0.3% ZYMAR AT + ALLERGAN 0.3% ZYMAXID 0.5% XX + ALLERGAN

A079084 001 N021493 001 N022548 001

Aug 19, 2011 Mar 28, 2003 May 18, 2010

GEMCITABINE HYDROCHLORIDE
INJECTABLE; INJECTION GEMCITABINE HYDROCHLORIDE ACCORD HLTHCARE EQ 200MG BASE/VIAL EQ 1GM BASE/VIAL EQ 2GM BASE/VIAL ACTAVIS TOTOWA EQ 200MG BASE/VIAL EQ 1GM BASE/VIAL APP PHARMS EQ 2GM BASE/VIAL DR REDDYS LABS LTD EQ 200MG BASE/VIAL EQ 1GM BASE/VIAL FRESENIUS KABI ONCOL EQ 200MG BASE/VIAL EQ 1GM BASE/VIAL EQ 2GM BASE/VIAL HOSPIRA EQ 200MG BASE/VIAL EQ 1GM BASE/VIAL + HOSPIRA INC EQ 2GM BASE/VIAL ONCO THERAPIES LTD EQ 200MG BASE/VIAL EQ 1GM BASE/VIAL EQ 2GM BASE/VIAL SUN PHARMA GLOBAL EQ 200MG BASE/VIAL EQ 1GM BASE/VIAL TEVA PARENTERAL EQ 200MG BASE/VIAL EQ 1GM BASE/VIAL WATSON LABS EQ 200MG BASE/VIAL EQ 1GM BASE/VIAL GEMZAR + LILLY EQ 200MG BASE/VIAL + EQ 1GM BASE/VIAL GEMCITABINE + HOSPIRA INC 200MG/5.26ML (38MG/ML) + 1GM/26.3ML (38MG/ML) + 2GM/52.6ML (38MG/ML)

AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP XX XX XX

A091594 A091594 A091594 A079160 A079160 A090242 A091365 A091365 A090799 A090799 A090799 A078339 A078339 A079183 A200145 A200145 A200145 A078433 A078433 A077983 A077983 A078759 A078759

001 002 003 001 002 003 001 002 001 002 003 001 002 001 001 002 003 001 002 002 001 001 002

Jul Jul Jul Jul Jul May Jul Jul Jul Jul May Jul Jul Nov Jul Jul Jul Jul Jul Jan Jan Jul Jul

25, 25, 25, 25, 25, 16, 25, 25, 25, 25, 16, 25, 25, 15, 25, 25, 25, 25, 25, 25, 25, 25, 25,

2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2010 2011 2011 2011 2011 2011 2011 2011 2011 2011

N020509 001 N020509 002 N200795 001 N200795 002 N200795 003

May 15, 1996 May 15, 1996 Aug 04, 2011 Aug 04, 2011 Aug 04, 2011

GEMFIBROZIL
TABLET; ORAL GEMFIBROZIL APOTEX AB BLU CARIBE AB

600MG 600MG

A075034 001 A078012 001

Jul 20, 1998 Mar 26, 2007

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

GEMFIBROZIL
TABLET; ORAL GEMFIBROZIL DAVA PHARMS INC HIKMA PHARMS IMPAX PHARMS INVAGEN PHARMS NORTHSTAR HLTHCARE SUN PHARM INDS INC TEVA WATSON LABS LOPID + PFIZER PHARMS

3 - 202 (of 424)

AB AB AB AB AB AB AB AB AB

600MG 600MG 600MG 600MG 600MG 600MG 600MG 600MG 600MG

A074270 A078599 A078207 A077836 A079072 A079239 A074256 A074442

001 001 001 001 001 001 001 001

Sep Aug Jun Jul Sep Dec Oct Apr

27, 16, 01, 27, 13, 29, 31, 28,

1993 2010 2007 2006 2010 2008 1993 1995

N018422 003

Nov 20, 1986

GEMIFLOXACIN MESYLATE
TABLET; ORAL

FACTIVE

XX + CORNERSTONE THERAP

EQ 320MG BASE

N021158 001

Apr 04, 2003

GENTAMICIN SULFATE
CREAM; TOPICAL GENTAMICIN SULFATE AT + FOUGERA PERRIGO NEW YORK AT TARO AT

EQ 0.1% BASE EQ 0.1% BASE EQ 0.1% BASE

A062531 001 A062307 001 A062427 001

Jul 05, 1984 May 26, 1983

INJECTABLE; INJECTION GENTAMICIN SULFATE AP + APP PHARMS EQ 10MG BASE/ML AP + EQ 40MG BASE/ML AP EQ 40MG BASE/ML HOSPIRA AP EQ 10MG BASE/ML AP EQ 10MG BASE/ML AP EQ 40MG BASE/ML GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER AP + B BRAUN EQ 0.8MG BASE/ML AP + EQ 1.2MG BASE/ML AP + EQ 1.4MG BASE/ML AP + EQ 1.6MG BASE/ML AP + EQ 1.8MG BASE/ML AP + EQ 2MG BASE/ML AP + EQ 2.4MG BASE/ML AP + EQ 40MG BASE/100ML AP + EQ 60MG BASE/100ML AP + EQ 70MG BASE/100ML AP + EQ 80MG BASE/100ML AP + EQ 90MG BASE/100ML AP + EQ 100MG BASE/100ML AP + EQ 120MG BASE/100ML HOSPIRA AP EQ 1.2MG BASE/ML AP EQ 1.4MG BASE/ML AP EQ 1.6MG BASE/ML AP EQ 1.8MG BASE/ML AP EQ 2MG BASE/ML AP EQ 60MG BASE/100ML AP EQ 70MG BASE/100ML AP EQ 80MG BASE/100ML AP EQ 90MG BASE/100ML AP EQ 100MG BASE/100ML ISOTONIC GENTAMICIN SULFATE IN PLASTIC CONTAINER BAXTER HLTHCARE AP EQ 0.8MG BASE/ML

A062356 A062356 A062366 A062420 A062612 A062420 A062814 A062814 A062814 A062814 A062814 A062814 A062814 A062814 A062814 A062814 A062814 A062814 A062814 A062814 A062414 A062414 A062414 A062414 A062414 A062414 A062414 A062414 A062414 A062414

001 002 001 001 004 002 001 002 003 004 005 006 007 008 009 010 011 012 013 014 001 002 003 004 005 006 007 008 009 010

Mar Mar Aug Aug Feb Aug Aug Aug Aug Aug Aug Aug Aug Aug Aug Aug Aug Aug Aug Aug Aug Aug Aug Aug Aug Aug Aug Aug Aug Aug

04, 04, 04, 15, 20, 15, 28, 28, 28, 28, 28, 28, 28, 28, 28, 28, 28, 28, 28, 28, 15, 15, 15, 15, 15, 15, 15, 15, 15, 15,

1982 1982 1983 1983 1986 1983 1987 1987 1987 1987 1987 1987 1987 1987 1987 1987 1987 1987 1987 1987 1983 1983 1983 1983 1983 1983 1983 1983 1983 1983

A062373 001

Sep 07, 1982

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

GENTAMICIN SULFATE
INJECTABLE; INJECTION ISOTONIC GENTAMICIN SULFATE IN PLASTIC CONTAINER BAXTER HLTHCARE AP EQ 1.2MG BASE/ML AP EQ 1.6MG BASE/ML AP EQ 2MG BASE/ML AP EQ 2.4MG BASE/ML AP EQ 40MG BASE/100ML AP EQ 60MG BASE/100ML AP EQ 80MG BASE/100ML AP EQ 100MG BASE/100ML AP EQ 120MG BASE/100ML OINTMENT; OPHTHALMIC GENTAMICIN SULFATE AT + AKORN FERA PHARMS AT OINTMENT; TOPICAL GENTAMICIN SULFATE FOUGERA AT AT + PERRIGO NEW YORK TARO AT

3 - 203 (of 424)

A062373 A062373 A062373 A062373 A062373 A062373 A062373 A062373 A062373

007 008 009 010 003 004 002 005 006

Sep Sep Sep Sep Sep Sep Sep Sep Sep

07, 07, 07, 07, 07, 07, 07, 07, 07,

1982 1982 1982 1982 1982 1982 1982 1982 1982

EQ 0.3% BASE EQ 0.3% BASE

A064093 001 A065024 001

Aug 31, 1995 Jul 30, 2004

EQ 0.1% BASE EQ 0.1% BASE EQ 0.1% BASE

A062533 001 A062351 001 A062477 001

Oct 05, 1984 Feb 18, 1982 Dec 23, 1983

AT AT AT AT AT AT

SOLUTION/DROPS; OPHTHALMIC GENOPTIC ALLERGAN EQ GENTAK AKORN EQ GENTAMICIN SULFATE AKORN EQ + BAUSCH AND LOMB EQ FALCON PHARMS EQ FERA PHARMS EQ

0.3% BASE 0.3% BASE 0.3% 0.3% 0.3% 0.3% BASE BASE BASE BASE

A062452 001 A064163 001 A062635 A064048 A062196 A065121 001 001 001 001

Oct 10, 1984 Oct 12, 2001 Jan 08, 1987 May 11, 1994 Jan 30, 2004

GENTAMICIN SULFATE; PREDNISOLONE ACETATE

OINTMENT; OPHTHALMIC

PRED-G

XX + ALLERGAN

EQ 0.3% BASE;0.6%

N050612 001

Dec 01, 1989

SUSPENSION/DROPS; OPHTHALMIC
PRED-G
XX + ALLERGAN EQ 0.3% BASE;1%

N050586 001

Jun 10, 1988

GLATIRAMER ACETATE

INJECTABLE; SUBCUTANEOUS

COPAXONE
XX + TEVA

20MG/ML

N020622 002

Feb 12, 2002

GLIMEPIRIDE
TABLET; ORAL AMARYL AB + SANOFI AVENTIS US AB AB GLIMEPIRIDE ACCORD HLTHCARE AB AB AB CARLSBAD AB AB AB COREPHARMA AB

1MG 2MG 4MG 1MG 2MG 4MG 1MG 2MG 4MG 1MG

N020496 001 N020496 002 N020496 003 A078181 A078181 A078181 A077911 A077911 A077911 A077274 001 002 003 001 002 003 001

Nov 30, 1995 Nov 30, 1995 Nov 30, 1995 Aug Aug Aug Sep Sep Sep Oct 23, 23, 23, 22, 22, 22, 06, 2007 2007 2007 2009 2009 2009 2005

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

GLIMEPIRIDE
TABLET; ORAL GLIMEPIRIDE COREPHARMA AB AB DR REDDYS LABS LTD AB AB AB INVAGEN PHARMS AB AB AB MYLAN AB AB AB AB AB AB RANBAXY AB AB AB AB TEVA AB AB AB VINTAGE AB AB AB AB WATSON LABS AB AB AB WATSON LABS FLORIDA AB AB AB

3 - 204 (of 424)

2MG 4MG 1MG 2MG 4MG 1MG 2MG 4MG 1MG 1MG 2MG 2MG 4MG 4MG 1MG 2MG 4MG 8MG 1MG 2MG 4MG 1MG 2MG 4MG 8MG 1MG 2MG 4MG 1MG 2MG 4MG

A077274 A077274 A077091 A077091 A077091 A077295 A077295 A077295 A077486 A077624 A077486 A077624 A077486 A077624 A076875 A076875 A076875 A076875 A076802 A076802 A076802 A077370 A077370 A077370 A077370 A077280 A077280 A077280 A076995 A076995 A076995

002 003 001 002 003 001 002 003 001 001 002 002 003 003 001 002 003 004 001 002 003 001 002 003 004 001 002 003 001 002 003

Oct Oct Oct Oct Oct Oct Oct Oct Feb Nov Feb Nov Feb Nov Oct Oct Oct Oct Oct Oct Oct Dec Dec Dec Dec Feb Feb Feb Apr Apr Apr

06, 06, 06, 06, 06, 06, 06, 06, 10, 28, 10, 28, 10, 28, 06, 06, 06, 06, 06, 06, 06, 23, 23, 23, 23, 03, 03, 03, 27, 27, 27,

2005 2005 2005 2005 2005 2005 2005 2005 2006 2005 2006 2005 2006 2005 2005 2005 2005 2005 2005 2005 2005 2005 2005 2005 2005 2006 2006 2006 2010 2010 2010

GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE

TABLET; ORAL

DUETACT

XX + TAKEDA GLOBAL XX

2MG;30MG 4MG;30MG

N021925 001 N021925 002

Jul 28, 2006 Jul 28, 2006

GLIMEPIRIDE; ROSIGLITAZONE MALEATE

TABLET; ORAL

AVANDARYL

XX + SB PHARMCO XX XX XX XX

1MG;4MG 2MG;4MG 2MG;8MG 4MG;4MG 4MG;8MG

N021700 N021700 N021700 N021700 N021700

001 002 004 003 005

Nov Nov Mar Nov Mar

23, 23, 30, 23, 30,

2005 2005 2007 2005 2007

GLIPIZIDE
TABLET; ORAL GLIPIZIDE ACCORD HLTHCARE INC AB AB APOTEX AB AB CARACO AB AB IVAX SUB TEVA PHARMS AB

5MG 10MG 5MG 10MG 5MG 10MG 5MG

A074550 A074550 A075795 A075795 A077820 A077820 A074497

001 002 001 002 001 002 001

Sep Sep Jun Jun Jul Jul Aug

11, 11, 13, 13, 11, 11, 31,

1997 1997 2001 2001 2006 2006 1995

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

GLIPIZIDE
TABLET; ORAL GLIPIZIDE IVAX SUB TEVA PHARMS AB MYLAN AB AB AB AB SANDOZ AB AB WATSON LABS AB AB AB AB GLUCOTROL PFIZER AB AB +

3 - 205 (of 424)

10MG 5MG 5MG 10MG 10MG 5MG 10MG 5MG 5MG 10MG 10MG 5MG 10MG

A074497 A074226 A074438 A074226 A074438 A074305 A074305 A074223 A074370 A074223 A074370

002 001 001 002 002 001 002 001 001 002 002

Aug May Jun May Jun Apr Apr Feb Nov Feb Nov

31, 10, 20, 10, 20, 07, 07, 27, 22, 27, 22,

1995 1994 1995 1994 1995 1995 1995 1995 1994 1995 1994

N017783 001 N017783 002

May 08, 1984 May 08, 1984

TABLET, EXTENDED RELEASE; ORAL GLIPIZIDE WATSON LABS AB 2.5MG AB 5MG AB 10MG GLUCOTROL XL PFIZER AB 2.5MG AB 5MG AB + 10MG

A076467 003 A076467 001 A076467 002 N020329 003 N020329 001 N020329 002

Mar 27, 2006 Sep 08, 2003 Nov 07, 2003 Aug 10, 1999 Apr 26, 1994 Apr 26, 1994

GLIPIZIDE; METFORMIN HYDROCHLORIDE

TABLET; ORAL GLIPIZIDE AND METFORMIN HYDROCHLORIDE CARACO AB 2.5MG;250MG AB 2.5MG;500MG AB 5MG;500MG COREPHARMA AB 2.5MG;250MG AB 2.5MG;500MG AB 5MG;500MG HERITAGE PHARMS INC AB 2.5MG;250MG AB 2.5MG;500MG AB 5MG;500MG MYLAN AB 2.5MG;250MG AB 2.5MG;500MG AB 5MG;500MG TEVA PHARMS AB 2.5MG;250MG AB 2.5MG;500MG AB + 5MG;500MG ZYDUS PHARMS USA INC 2.5MG;250MG AB AB 2.5MG;500MG AB 5MG;500MG

A077620 A077620 A077620 A077507 A077507 A077507 A078728 A078728 A078728 A078083 A078083 A078083 A077270 A077270 A077270 A078905 A078905 A078905

001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003

Jan Jan Jan Oct Oct Oct Jun Jun Jun Apr Apr Apr Oct Oct Oct Jan Jan Jan

11, 11, 11, 27, 27, 27, 23, 23, 23, 12, 12, 12, 28, 28, 28, 31, 31, 31,

2008 2008 2008 2005 2005 2005 2010 2010 2010 2007 2007 2007 2005 2005 2005 2011 2011 2011

GLUCAGON HYDROCHLORIDE RECOMBINANT

INJECTABLE; INJECTION

GLUCAGEN

XX + NOVO NORDISK

EQ 1MG BASE/VIAL

N020918 001

Jun 22, 1998

GLUCAGON RECOMBINANT
INJECTABLE; INJECTION

GLUCAGON

XX + LILLY

1MG/VIAL

N020928 001

Sep 11, 1998

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

GLUTAMINE
FOR SOLUTION; ORAL

NUTRESTORE

XX + EMMAUS MEDCL

3 - 206 (of 424)

5GM/PACKET

N021667 001

Jun 10, 2004

GLYBURIDE
TABLET; ORAL GLYBURIDE AUROBINDO PHARMA AB AB AB COREPHARMA AB AB AB HERITAGE PHARMS INC AB AB AB TEVA AB AB AB + GLYBURIDE (MICRONIZED) DAVA PHARMS INC AB AB AB AB HIKMA AB AB AB MYLAN AB AB AB TEVA AB AB AB AB GLYNASE PHARMACIA AND UPJOHN AB AB AB + DIABETA BX SANOFI AVENTIS US BX BX +

1.25MG 2.5MG 5MG 1.25MG 2.5MG 5MG 1.25MG 2.5MG 5MG 1.25MG 2.5MG 5MG 1.5MG 3MG 4.5MG 6MG 1.5MG 3MG 6MG 1.5MG 3MG 6MG 1.5MG 3MG 4.5MG 6MG 1.5MG 3MG 6MG 1.25MG 2.5MG 5MG

A077537 A077537 A077537 A076257 A076257 A076257 A090937 A090937 A090937 A074388 A074388 A074388 A074591 A074591 A074591 A074591 A075890 A075890 A075890 A074792 A074792 A074792 A074686 A074686 A074686 A074686

001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 004 001 002 003 001 002 003 001 002 003 004

Oct Oct Oct Jun Jun Jun Feb Feb Feb Aug Aug Aug Dec Dec Dec Dec Jul Jul Jul Jun Jun Aug Apr Apr Apr Apr

18, 18, 18, 27, 27, 27, 28, 28, 28, 29, 29, 29, 22, 22, 22, 22, 31, 31, 31, 26, 26, 17, 20, 20, 20, 20,

2007 2007 2007 2002 2002 2002 2011 2011 2011 1995 1995 1995 1997 1997 1997 1997 2003 2003 2003 1998 1998 1999 1999 1999 1999 1999

N020051 001 N020051 002 N020051 004 N017532 001 N017532 002 N017532 003

Mar 04, 1992 Mar 04, 1992 Sep 24, 1993 May 01, 1984 May 01, 1984 May 01, 1984

GLYBURIDE; METFORMIN HYDROCHLORIDE

TABLET; ORAL GLUCOVANCE BRISTOL MYERS SQUIBB AB AB + AB GLYBURIDE AND METFORMIN ACTAVIS ELIZABETH AB AB AB AUROBINDO PHARMA AB AB AB COREPHARMA AB AB AB

1.25MG;250MG 2.5MG;500MG 5MG;500MG HYDROCHLORIDE 1.25MG;250MG 2.5MG;500MG 5MG;500MG 1.25MG;250MG 2.5MG;500MG 5MG;500MG 1.25MG;250MG 2.5MG;500MG 5MG;500MG

N021178 001 N021178 002 N021178 003 A076716 A076716 A076716 A077870 A077870 A077870 A076731 A076731 A076731 001 002 003 001 002 003 001 002 003

Jul 31, 2000 Jul 31, 2000 Jul 31, 2000 Jun Jun Jun Nov Nov Nov Nov Nov Nov 28, 28, 28, 14, 14, 14, 19, 19, 19, 2005 2005 2005 2007 2007 2007 2004 2004 2004

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

GLYBURIDE; METFORMIN HYDROCHLORIDE
TABLET; ORAL GLYBURIDE AND METFORMIN HYDROCHLORIDE DR REDDYS LABS INC AB 1.25MG;250MG AB 2.5MG;500MG AB 5MG;500MG IVAX SUB TEVA PHARMS 1.25MG;250MG AB AB 2.5MG;500MG AB 5MG;500MG

3 - 207 (of 424)

A079009 A079009 A079009 A076345 A076345 A076345

001 002 003 001 002 003

Jun Jun Jun Feb Feb Feb

03, 03, 03, 18, 18, 18,

2009 2009 2009 2004 2004 2004

GLYCINE
SOLUTION; IRRIGATION AMINOACETIC ACID 1.5% IN PLASTIC CONTAINER BAXTER HLTHCARE AT 1.5GM/100ML GLYCINE 1.5% IN PLASTIC CONTAINER B BRAUN AT 1.5GM/100ML HOSPIRA AT 1.5GM/100ML

N017865 001 N016784 001 N018315 001

GLYCOPYRROLATE
INJECTABLE; INJECTION GLYCOPYRROLATE HIKMA FARMACEUTICA AP LUITPOLD AP ROBINUL AP + BAXTER HLTHCARE SOLUTION; ORAL
CUVPOSA
XX + SHIONOGI INC TABLET; ORAL GLYCOPYRROLATE BOCA PHARMA AA AA COREPHARMA AA AA DR REDDYS LABS LTD AA AA PAR PHARM AA AA RANBAXY AA AA VINTAGE AA AA WEST WARD AA AA ROBINUL AA + SHIONOGI INC ROBINUL FORTE AA + SHIONOGI INC

0.2MG/ML 0.2MG/ML 0.2MG/ML

A090963 001 A089335 001 N017558 001

Sep 21, 2011 Jul 23, 1986

1MG/5ML

N022571 001

Jul 28, 2010

1MG 2MG 1MG 2MG 1MG 2MG 1MG 2MG 1MG 2MG 1MG 2MG 1MG 2MG 1MG 2MG

A090020 A090020 A040568 A040568 A040847 A040847 A040653 A040653 A040844 A040844 A040821 A040821 A040836 A040836

001 002 001 002 001 002 001 002 001 002 001 002 001 002

Oct Oct Dec Dec Mar Mar Aug Aug Aug Aug Dec Dec Mar Mar

19, 19, 22, 22, 21, 21, 31, 31, 18, 18, 29, 29, 05, 05,

2011 2011 2004 2004 2008 2008 2006 2006 2009 2009 2008 2008 2009 2009

N012827 001 N012827 002

GONADOTROPIN, CHORIONIC
INJECTABLE; INJECTION CHORIONIC GONADOTROPIN AP + APP PHARMS AP + FERRING PREGNYL AP + ORGANON USA INC

10,000 UNITS/VIAL 10,000 UNITS/VIAL 10,000 UNITS/VIAL

N017067 002 N017016 007 N017692 001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

GOSERELIN ACETATE
IMPLANT; IMPLANTATION

ZOLADEX

XX + ASTRAZENECA XX +

3 - 208 (of 424)

EQ 3.6MG BASE EQ 10.8MG BASE

N019726 001 N020578 001

Dec 29, 1989 Jan 11, 1996

GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

SOLUTION/DROPS; OPHTHALMIC NEOMYCIN AND POLYMYXIN B SULFATES AND AT + BAUSCH AND LOMB 0.025MG/ML;EQ UNITS/ML LUITPOLD AT 0.025MG/ML;EQ UNITS/ML NEOSPORIN AT + MONARCH PHARMS 0.025MG/ML;EQ UNITS/ML GRAMICIDIN 1.75MG BASE/ML;10,000 1.75MG BASE/ML;10,000

A064047 001 A065187 001

Jan 31, 1996 Oct 28, 2005

1.75MG BASE/ML;10,000

A060582 001

GRANISETRON

FILM, EXTENDED RELEASE; TRANSDERMAL

SANCUSO
XX + PROSTRAKAN INC 3.1MG/24HR

N022198 001

Sep 12, 2008

GRANISETRON HYDROCHLORIDE
INJECTABLE; INJECTION GRANISETRON HYDROCHLORIDE AKORN INC EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) EQ 4MG BASE/4ML (EQ 1MG BASE/ML) EQ 1MG BASE/ML (EQ 1MG BASE/ML) APP PHARMS EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) EQ 4MG BASE/4ML (EQ 1MG BASE/ML) BAXTER HLTHCARE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) BEDFORD LABS EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) EQ 4MG BASE/4ML (EQ 1MG BASE/ML) EQ 1MG BASE/ML (EQ 1MG BASE/ML) CLARIS LIFESCIENCES EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) EQ 1MG BASE/ML (EQ 1MG BASE/ML) EQ 4MG BASE/4ML (EQ 1MG BASE/ML) DR REDDYS LABS INC EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) EQ 4MG BASE/4ML (EQ 1MG BASE/ML) EBEWE PHARMA EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) EQ 1MG BASE/ML (EQ 1MG BASE/ML) EQ 4MG BASE/4ML (EQ 1MG BASE/ML) LUITPOLD EQ 1MG BASE/ML (EQ 1MG BASE/ML) SAGENT STRIDES EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) EQ 1MG BASE/ML (EQ 1MG BASE/ML) EQ 4MG BASE/4ML (EQ 1MG BASE/ML) SANDOZ EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) EQ 1MG BASE/ML (EQ 1MG BASE/ML) EQ 4MG BASE/4ML (EQ 1MG BASE/ML) + TEVA PARENTERAL EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) + EQ 1MG BASE/ML (EQ 1MG BASE/ML) + EQ 4MG BASE/4ML (EQ 1MG BASE/ML) WATSON LABS EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) EQ 1MG BASE/ML (EQ 1MG BASE/ML) EQ 4MG BASE/4ML (EQ 1MG BASE/ML) WOCKHARDT USA EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) EQ 1MG BASE/ML (EQ 1MG BASE/ML) EQ 4MG BASE/4ML (EQ 1MG BASE/ML) GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE APP PHARMS EQ 1MG BASE/ML (EQ 1MG BASE/ML)

AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP

A079119 A079078 A079078 A078522 A078090 A077177 A077913 A077186 A077187 A078197 A078198 A078198 A078863 A078880 A078808 A078835 A078835 A091274 A091136 A091136 A091137 A078534 A078531 A078531 A078392 A077963 A077297 A078262 A078258 A078258 A078566 A078564 A078565

001 002 001 001 001 001 001 001 001 001 001 002 001 001 001 001 002 001 001 002 002 001 001 002 001 001 001 001 001 002 001 001 001

Sep Sep Sep Dec Jun Dec Jun Jun Jun Dec Jun Jun Jun Jun Apr Jun Jun Sep Apr Apr Apr Apr Apr Apr Dec Jan Jun Dec Jun Jun Feb Jun Jun

10, 14, 14, 31, 30, 31, 26, 30, 30, 31, 30, 30, 30, 30, 29, 30, 30, 22, 09, 09, 09, 30, 30, 30, 31, 03, 30, 31, 30, 30, 29, 30, 30,

2009 2009 2009 2007 2008 2007 2008 2008 2008 2007 2008 2008 2008 2008 2008 2008 2008 2010 2010 2010 2010 2009 2009 2009 2007 2008 2008 2007 2008 2008 2008 2008 2008

A078096 001

Jun 30, 2008

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

GRANISETRON HYDROCHLORIDE
INJECTABLE; INJECTION GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE DR REDDYS LABS INC EQ 1MG BASE/ML (EQ 1MG BASE/ML) + TEVA PARENTERAL EQ 1MG BASE/ML (EQ 1MG BASE/ML) GRANISTERON HYDROCHLORIDE HIKMA FARMACEUTICA EQ 1MG BASE/ML (EQ 1MG BASE/ML) EQ 4MG BASE/4ML (EQ 1MG BASE/ML)

3 - 209 (of 424)

AP AP AP AP

A078863 002 A077165 001 A078629 001 A078629 002

Jun 30, 2008

Dec 31, 2007
Dec 23, 2009
Dec 23, 2009

SOLUTION; ORAL
GRANISETRON HYDROCHLORIDE
EQ 2MG BASE/10ML XX + PEDIATRX TABLET; ORAL GRANISETRON HYDROCHLORIDE APOTEX INC EQ CIPLA LTD EQ COREPHARMA EQ DR REDDYS LABS LTD EQ MYLAN EQ NATCO PHARMA EQ ORCHID HLTHCARE EQ ROXANE EQ TARO EQ EQ + TEVA PHARMS

A078334 001

Feb 28, 2008

AB AB AB AB AB AB AB AB AB AB

1MG 1MG 1MG 1MG 1MG 1MG 1MG 1MG 1MG 1MG

BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE

A078843 A078037 A078260 A078846 A078725 A078969 A078678 A077842 A090817 A078080

001 001 001 001 001 001 001 001 001 001

Feb Feb Dec Feb Jan Jun Feb Dec May Dec

27, 27, 31, 27, 30, 22, 13, 31, 28, 31,

2008 2008 2007 2009 2008 2009 2008 2007 2010 2007

GRISEOFULVIN
SUSPENSION; ORAL GRISEOFULVIN VINTAGE AB

125MG/5ML

A065438 001

Oct 08, 2010

GRISEOFULVIN, MICROCRYSTALLINE
SUSPENSION; ORAL GRIFULVIN V + ORTHONEUTROGENA GRISEOFULVIN ACTAVIS MID ATLANTIC IVAX SUB TEVA PHARMS PERRIGO CO TENNESSEE

AB AB AB AB

125MG/5ML 125MG/5ML 125MG/5ML 125MG/5ML

A062483 001 A065394 001 A065354 001 A065200 001

Jan 26, 1984 Jul 06, 2007 Sep 10, 2007 Mar 02, 2005

TABLET; ORAL
GRIFULVIN V
XX + ORTHONEUTROGENA

500MG

A062279 003

GRISEOFULVIN, ULTRAMICROCRYSTALLINE
TABLET; ORAL
GRIS-PEG
PEDINOL
XX XX +

125MG 250MG

N050475 001
N050475 002

GUANABENZ ACETATE
TABLET; ORAL GUANABENZ ACETATE IVAX SUB TEVA PHARMS XX XX +

EQ 4MG BASE EQ 8MG BASE

A074149 001
A074149 002

Apr 07, 1995

Apr 07, 1995

GUANFACINE HYDROCHLORIDE
TABLET; ORAL GUANFACINE HYDROCHLORIDE AMNEAL PHARM AB EQ 1MG BASE AB EQ 2MG BASE EPIC PHARMA AB EQ 1MG BASE

A075109 001 A075109 002 A074673 001

Nov 25, 1998 Nov 25, 1998 Feb 28, 1997

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

GUANFACINE HYDROCHLORIDE
TABLET; ORAL GUANFACINE HYDROCHLORIDE EPIC PHARMA EQ MYLAN EQ EQ WATSON LABS EQ EQ TENEX PROMIUS PHARMA EQ + EQ

3 - 210 (of 424)

AB AB AB AB AB AB AB

2MG 1MG 2MG 1MG 2MG

BASE BASE BASE BASE BASE

A074673 A074796 A074796 A074145 A074145

002 001 002 001 002

Feb Jan Jan Oct Oct

28, 27, 27, 17, 17,

1997 1997 1997 1995 1995

1MG BASE 2MG BASE

N019032 001 N019032 002

Oct 27, 1986 Nov 07, 1988

TABLET, EXTENDED RELEASE; ORAL INTUNIV SHIRE EQ 1MG XX EQ 2MG XX EQ 3MG XX EQ 4MG XX +

BASE BASE BASE BASE

N022037 N022037 N022037 N022037

001 002 003 004

Sep Sep Sep Sep

02, 02, 02, 02,

2009 2009 2009 2009

GUANIDINE HYDROCHLORIDE
TABLET; ORAL

GUANIDINE HYDROCHLORIDE

SCHERING 125MG XX

N001546 001

HALCINONIDE
CREAM; TOPICAL

HALOG

XX + RANBAXY OINTMENT; TOPICAL

HALOG

XX + RANBAXY

0.1%

N017556 001

0.1%

N017824 001

HALOBETASOL PROPIONATE
CREAM; TOPICAL HALOBETASOL PROPIONATE ALTANA G AND W LABS PERRIGO ISRAEL TARO ULTRAVATE + RANBAXY OINTMENT; TOPICAL HALOBETASOL PROPIONATE ALTANA G AND W LABS PERRIGO TARO ULTRAVATE + RANBAXY

AB AB AB AB AB

0.05% 0.05% 0.05% 0.05% 0.05%

A077001 A078162 A077123 A077227

001 001 001 001

Dec Apr Dec Aug

16, 24, 16, 04,

2004 2007 2004 2005

N019967 001

Dec 27, 1990

AB AB AB AB AB

0.05% 0.05% 0.05% 0.05% 0.05%

A076903 A077721 A076872 A076994

001 001 001 001

Dec Sep Dec Dec

16, 07, 16, 16,

2004 2006 2004 2004

N019968 001

Dec 17, 1990

HALOPERIDOL
TABLET; ORAL HALOPERIDOL MYLAN AB AB AB AB AB AB SANDOZ AB

0.5MG 1MG 2MG 5MG 10MG 20MG 0.5MG

A070278 A070278 A070278 A070278 A070278 A070278 A071206

006 004 001 005 002 003 001

Jun Jun Jun Jun Jul Jul Nov

10, 10, 10, 10, 16, 16, 17,

1986 1986 1986 1986 2009 2009 1986

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

HALOPERIDOL
TABLET; ORAL HALOPERIDOL SANDOZ AB AB + AB AB AB ZYDUS PHARMS USA AB AB AB

3 - 211 (of 424)

1MG 2MG 5MG 10MG 20MG 5MG 10MG 20MG

A071207 A071208 A071209 A071210 A071211 A077580 A077580 A077580

001 001 001 001 001 003 004 005

Nov Nov Nov Mar Mar Nov Nov Nov

17, 17, 17, 11, 11, 29, 29, 29,

1986 1986 1986 1988 1988 2007 2007 2007

HALOPERIDOL DECANOATE
INJECTABLE; INJECTION HALDOL AO + JANSSEN PHARMS AO + HALOPERIDOL DECANOATE APP PHARMS AO AO BEDFORD AO AO CLARIS LIFESCIENCES AO AO TEVA PARENTERAL AO AO

EQ 50MG BASE/ML EQ 100MG BASE/ML EQ EQ EQ EQ EQ EQ EQ EQ 50MG BASE/ML 100MG BASE/ML 50MG BASE/ML 100MG BASE/ML 50MG BASE/ML 100MG BASE/ML 50MG BASE/ML 100MG BASE/ML

N018701 001 N018701 002 A074893 A074893 A074811 A075305 A075440 A075440 A075393 A075393 001 002 001 001 001 002 001 002

Jan 14, 1986 Jan 31, 1997 Dec Dec Jan Sep Feb Feb May May 19, 19, 30, 28, 28, 28, 11, 11, 1997 1997 1998 1998 2000 2000 1999 1999

HALOPERIDOL LACTATE
CONCENTRATE; ORAL HALOPERIDOL PHARM ASSOC AA SILARX AA AA + TEVA PHARMS INJECTABLE; INJECTION HALDOL + JANSSEN PHARMS HALOPERIDOL APP PHARMS BEDFORD CLARIS LIFESCIENCES GLAND PHARMA LTD PFIZER SAGENT PHARMS TEVA PARENTERAL

EQ 2MG BASE/ML EQ 2MG BASE/ML EQ 2MG BASE/ML

A073037 001 A073364 001 A071617 001

Feb 26, 1993 Sep 28, 1993 Dec 01, 1988

AP AP AP AP AP AP AP AP AP AP

EQ 5MG BASE/ML EQ EQ EQ EQ EQ EQ EQ EQ EQ 5MG 5MG 5MG 5MG 5MG 5MG 5MG 5MG 5MG BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML

N015923 001 A075689 A075858 A076791 A076828 A076774 A078347 A091637 A200742 A076035 001 001 001 001 001 001 001 001 001 Mar Jun Aug Aug Aug Sep Sep Sep Aug 09, 18, 25, 25, 25, 14, 02, 02, 29, 2001 2001 2004 2004 2004 2009 2011 2011 2001

HEPARIN SODIUM
INJECTABLE; INJECTION HEPARIN SODIUM + APP PHARMS + + + + BAXTER HLTHCARE + + HOSPIRA HOSPIRA INC

AP AP AP AP AP AP AP AP AP AP

1,000 UNITS/ML 5,000 UNITS/ML 10,000 UNITS/ML 20,000 UNITS/ML 1,000 UNITS/ML 5,000 UNITS/ML 10,000 UNITS/ML 5,000 UNITS/ML 1,000 UNITS/ML 5,000 UNITS/ML

N017029 N017651 N017029 N017029 N017037 N017037 N017037 A088100 A090571 A090571

001 006 003 004 001 002 003 001 001 002

Apr 28, 1983 Aug 31, 2009 Aug 31, 2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

HEPARIN SODIUM
INJECTABLE; INJECTION HEPARIN SODIUM HOSPIRA INC AP 10,000 UNITS/ML A090571 SAGENT PHARMS AP 1,000 UNITS/ML A090808 AP 5,000 UNITS/ML A090808 AP 10,000 UNITS/ML A090808 AP 20,000 UNITS/ML A090809 SANDOZ AP 1,000 UNITS/ML A091682 AP 5,000 UNITS/ML A091659 AP 5,000 UNITS/ML A091682 AP 10,000 UNITS/ML A201002 HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER BAXTER HLTHCARE AP 200 UNITS/100ML N018609 HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER B BRAUN AP 200 UNITS/100ML N019953 HOSPIRA AP 200 UNITS/100ML N018916 HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER HOSPIRA AP 10,000 UNITS/100ML N019339 HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER BAXTER HLTHCARE AP 200 UNITS/100ML N018609 HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HOSPIRA AP 200 UNITS/100ML N018916 HEPARIN SODIUM 20,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER BAXTER HLTHCARE AP 4,000 UNITS/100ML N018814 HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER B BRAUN AP 4,000 UNITS/100ML N019952 HOSPIRA AP 4,000 UNITS/100ML N019805 HEPARIN SODIUM 25,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER BAXTER HLTHCARE AP 5,000 UNITS/100ML N018814 AP 10,000 UNITS/100ML N018814 HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER B BRAUN AP 5,000 UNITS/100ML N019952 AP 10,000 UNITS/100ML N019952 HOSPIRA AP 5,000 UNITS/100ML N019339 AP 5,000 UNITS/100ML N019805 AP 10,000 UNITS/100ML N019339 HEPARIN SODIUM IN PLASTIC CONTAINER AP + APP PHARMS 1,000 UNITS/ML N017029 AP + 5,000 UNITS/ML N017029 AP + 10,000 UNITS/ML N017029 AP + 20,000 UNITS/ML N017029 HEPARIN SODIUM PRESERVATIVE FREE AP + APP PHARMS 1,000 UNITS/ML N017029 AP + HOSPIRA 10,000 UNITS/ML A089522 SAGENT PHARMS AP 1,000 UNITS/ML A090810 HEPARIN SODIUM PFIZER 1,000 UNITS/ML N201370 XX 5,000 UNITS/ML N201370 XX 10,000 UNITS/ML N201370 XX HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER HOSPIRA 5,000 UNITS/100ML N019339 XX HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER HOSPIRA 5,000 UNITS/100ML N018916 XX HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER HOSPIRA 5,000 UNITS/100ML N018916 XX 10,000 UNITS/100ML N018916 XX HEPARIN SODIUM PRESERVATIVE FREE PFIZER 1,000 UNITS/ML N201370 XX

3 - 212 (of 424)

003 001 002 003 001 001 001 002 001 001 001 010 003 002 011 001 001 001 003 004 004 005 004 002 002 013 014 015 016 010 001 001 001 002 003 001 006 007 008 004

Aug Jun Jun Jun Jun Jun Jun Jun Jun

31, 30, 30, 30, 30, 08, 08, 08, 08,

2009 2010 2010 2010 2010 2011 2011 2011 2011

Apr 28, 1982 Jul 20, 1992 Jun 23, 1989 Mar 27, 1985 Apr 28, 1982 Jun 23, 1989 Oct 31, 1983 Jul 20, 1992 Jan 25, 1989 Jul 09, 1985 Jul 02, 1987 Jul Jul Mar Jan Mar Dec Dec Dec Dec 20, 20, 27, 25, 27, 05, 05, 05, 05, 1992 1992 1985 1989 1985 1985 1985 1985 1985

Apr 28, 1986 May 04, 1987 Jun 30, 2010 Jul 21, 2011 Jul 21, 2011 Jul 21, 2011 Mar 27, 1985 Jan 31, 1984 Jan 31, 1984 Jan 31, 1984 Jul 21, 2011

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

HEXACHLOROPHENE
EMULSION; TOPICAL

PHISOHEX

XX + SANOFI AVENTIS US SPONGE; TOPICAL PRE-OP AT + DAVIS AND GECK PRE-OP II DAVIS AND GECK AT

3 - 213 (of 424)

3%

N006882 001

480MG 480MG

N017433 001 N017433 002

HEXAMINOLEVULINATE HYDROCHLORIDE

FOR SOLUTION; INTRAVESICAL

CYSVIEW KIT
100MG/VIAL XX + GE HEALTHCARE

N022555 001

May 28, 2010

HISTRELIN ACETATE

IMPLANT; SUBCUTANEOUS

SUPPRELIN LA
XX + ENDO PHARM VANTAS XX + ENDO PHARM

50MG 50MG

N022058 001 N021732 001

May 03, 2007 Oct 12, 2004

HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE

SYRUP; ORAL HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE ACTAVIS MID ATLANTIC 1.5MG/5ML;5MG/5ML AA AA + HI TECH PHARMA 1.5MG/5ML;5MG/5ML WOCKHARDT AA 1.5MG/5ML;5MG/5ML TABLET; ORAL HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE NOVEL LABS INC AB 1.5MG;5MG TUSSIGON AB + KING PHARMS 1.5MG;5MG

A088017 001 A040613 001 A088008 001

Jul 05, 1983 Feb 08, 2008 Mar 03, 1983

A091528 001 A088508 001

Apr 20, 2011 Jul 30, 1985

HYALURONIDASE

INJECTABLE; INJECTION

AMPHADASE
XX + AMPHASTAR PHARM HYDASE XX + AKORN INC VITRASE XX + ISTA PHARMS

150 UNITS/ML 150 UNITS/ML 200 UNITS/VIAL

N021665 001 N021716 001 N021640 002

Oct 26, 2004 Oct 25, 2005 Dec 02, 2004

HYALURONIDASE RECOMBINANT HUMAN

INJECTABLE; INJECTION

HYLENEX RECOMBINANT
XX + HALOZYME THERAP

150 UNITS/ML

N021859 001

Dec 02, 2005

HYDRALAZINE HYDROCHLORIDE
INJECTABLE; INJECTION HYDRALAZINE HYDROCHLORIDE AKORN AP 20MG/ML APP PHARMS AP 20MG/ML AP + LUITPOLD 20MG/ML TABLET; ORAL HYDRALAZINE HYDROCHLORIDE GLENMARK PHARMS LTD AA 10MG AA 25MG AA 50MG

A040730 001 A040388 001 A040136 001

Apr 21, 2009 Mar 13, 2001 Jun 30, 1997

A090527 001 A090527 002 A090527 003

May 27, 2009 May 27, 2009 May 27, 2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

HYDRALAZINE HYDROCHLORIDE
TABLET; ORAL HYDRALAZINE HYDROCHLORIDE GLENMARK PHARMS LTD 100MG HERITAGE PHARMS INC 10MG 25MG 50MG 100MG HETERO LABS UNIT III 10MG 25MG 50MG 100MG INVAGEN PHARMS 10MG 25MG 50MG 100MG MYLAN 10MG 25MG 50MG 100MG PAR PHARM 10MG 25MG 50MG 100MG + PLIVA 10MG + 25MG + 50MG + 100MG WATSON LABS 25MG 50MG ZYDUS PHARMS USA 10MG 25MG 50MG 100MG

3 - 214 (of 424)

AA AA AA AA AA AA AA AA AA AA AA AA AA AA AA AA AA AA AA AA AA AA AA AA AA AA AA AA AA AA AA

A090527 A086242 A086242 A086242 A086242 A040901 A040901 A040901 A040901 A090255 A090255 A090255 A090255 A090413 A090413 A090413 A090413 A087836 A086961 A086962 A088391 A089097 A088467 A088468 A089098 A084504 A084503 A040858 A040858 A040858 A040858

004 001 003 002 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 001 001 001 001 001 001 001 001 001 002 003 004

May 27, 2009 Feb 04, 2010

Feb Sep Sep Sep Sep Dec Dec Dec Dec Dec Dec Dec Dec Oct

04, 12, 12, 12, 12, 15, 15, 15, 15, 08, 08, 08, 08, 05,

2010 2008 2008 2008 2008 2008 2008 2008 2008 2010 2010 2010 2010 1982

Sep Dec May May Dec

27, 18, 01, 01, 18,

1983 1985 1984 1984 1985

Feb Feb Feb Feb

26, 26, 26, 26,

2010 2010 2010 2010

HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

CAPSULE; ORAL HYDRA-ZIDE PAR PHARM XX XX +

25MG;25MG 50MG;50MG

A088957 001 A088946 001

Oct 21, 1985 Oct 21, 1985

HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE

TABLET; ORAL

BIDIL

XX + ARBOR PHARMS INC

37.5MG;20MG

N020727 001

Jun 23, 2005

HYDROCHLOROTHIAZIDE
CAPSULE; ORAL HYDROCHLOROTHIAZIDE ALEMBIC PHARMS LTD APOTEX AUROBINDO PHARMA IPCA LABS LTD IVAX SUB TEVA PHARMS JUBILANT CADISTA MYLAN UNICHEM VINTAGE PHARMS WEST WARD

AB AB AB AB AB AB AB AB AB AB

12.5MG 12.5MG 12.5MG 12.5MG 12.5MG 12.5MG 12.5MG 12.5MG 12.5MG 12.5MG

A200645 A078389 A078164 A079237 A077005 A078391 A075640 A090510 A075907 A077885

001 001 001 001 001 001 001 001 001 001

Nov May Sep Apr Jul Feb Jan Jan Sep Nov

30, 16, 18, 02, 13, 11, 28, 19, 17, 26,

2010 2008 2007 2009 2005 2008 2000 2010 2002 2007

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

HYDROCHLOROTHIAZIDE
CAPSULE; ORAL MICROZIDE AB + WATSON LABS TABLET; ORAL HYDROCHLOROTHIAZIDE ACTAVIS ELIZABETH AB APOTEX AB AB AUROBINDO PHARMA AB AB CARACO AB AB AB DAVA PHARMS INC AB AB EXCELLIUM AB AB HERITAGE PHARMS INC AB AB IPCA LABS LTD AB AB AB IVAX SUB TEVA PHARMS AB AB + JUBILANT CADISTA AB AB LANNETT AB AB MYLAN AB MYLAN PHARMS INC AB AB UNICHEM AB AB VINTAGE PHARMS AB AB WATSON LABS AB WEST WARD AB AB ORETIC ABBOTT AB

3 - 215 (of 424)

12.5MG

N020504 001

Dec 27, 1996

12.5MG 25MG 50MG 25MG 50MG 12.5MG 25MG 50MG 25MG 50MG 25MG 50MG 25MG 50MG 12.5MG 25MG 50MG 25MG 50MG 25MG 50MG 25MG 50MG 12.5MG 25MG 50MG 25MG 50MG 25MG 50MG 25MG 25MG 50MG 50MG

A040707 A040774 A040774 A040780 A040780 A040857 A040810 A040810 A087059 A087068 A040702 A040702 A085182 A085182 A040807 A040807 A040807 A083177 A083177 A040809 A040809 A084325 A084324 A040770 A040735 A040735 A040907 A040907 A040412 A040412 A081189 A084878 A084878

001 001 002 001 002 001 001 002 001 001 001 002 002 001 001 002 003 001 002 001 002 001 001 001 002 003 001 002 001 002 001 002 001

Feb Oct Oct Jul Jul May Mar Mar

27, 03, 03, 20, 20, 30, 27, 27,

2007 2007 2007 2007 2007 2008 2007 2007

Mar 16, 2007 Mar 16, 2007

Jul 20, 2007 Jul 20, 2007 Jul 20, 2007

Sep 04, 2007 Sep 04, 2007

Jan Jan Jan Aug Aug Mar Mar Jan Jul

23, 23, 23, 15, 15, 29, 29, 24, 12,

2007 2007 2007 2008 2008 2002 2002 1992 2006

N011971 002

HYDROCHLOROTHIAZIDE; IRBESARTAN
TABLET; ORAL
AVALIDE
XX + SANOFI AVENTIS XX

12.5MG;150MG 12.5MG;300MG

N020758 002 N020758 003

Sep 30, 1997 Aug 31, 1998

HYDROCHLOROTHIAZIDE; LISINOPRIL
TABLET; ORAL LISINOPRIL AND HYDROCHLOROTHIAZIDE APOTEX INC AB 12.5MG;10MG AB 12.5MG;20MG AB 25MG;20MG AUROBINDO AB 12.5MG;10MG AB 12.5MG;20MG AB 25MG;20MG IVAX SUB TEVA PHARMS 12.5MG;10MG AB AB 12.5MG;20MG AB 25MG;20MG

A076674 A076674 A076674 A077606 A077606 A077606 A075776 A075776 A075776

001 002 003 001 002 003 001 002 003

Oct Oct Oct Mar Mar Mar Jul Jul Jul

05, 05, 05, 14, 14, 14, 01, 01, 01,

2004 2004 2004 2006 2006 2006 2002 2002 2002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

HYDROCHLOROTHIAZIDE; LISINOPRIL
TABLET; ORAL LISINOPRIL AND HYDROCHLOROTHIAZIDE LUPIN AB 12.5MG;10MG AB 12.5MG;20MG AB 25MG;20MG MYLAN AB 12.5MG;10MG AB 12.5MG;20MG AB 25MG;20MG PRINSTON INC AB 12.5MG;10MG AB 12.5MG;20MG AB 25MG;20MG RANBAXY AB 12.5MG;10MG AB 12.5MG;20MG AB 25MG;20MG SANDOZ AB 12.5MG;10MG AB 12.5MG;20MG AB 25MG;20MG WATSON LABS AB 12.5MG;10MG AB 12.5MG;20MG AB 25MG;20MG WEST WARD AB 12.5MG;10MG AB 12.5MG;20MG AB 25MG;20MG PRINZIDE MERCK AB 12.5MG;10MG AB 12.5MG;20MG ZESTORETIC ASTRAZENECA AB 12.5MG;10MG AB + 12.5MG;20MG AB + 25MG;20MG

3 - 216 (of 424)

A077912 A077912 A077912 A076113 A076113 A076113 A076230 A076230 A076230 A076007 A076007 A076007 A076262 A076262 A076262 A076194 A076194 A076194 A076265 A076265 A076265

001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 003 001 002 001 002 003

Sep Sep Sep Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul

27, 27, 27, 01, 01, 01, 01, 01, 01, 01, 01, 01, 01, 01, 01, 01, 01, 01, 08, 08, 08,

2006 2006 2006 2002 2002 2002 2002 2002 2002 2002 2002 2002 2002 2002 2002 2002 2002 2002 2002 2002 2002

N019778 003 N019778 001 N019888 003 N019888 001 N019888 002

Nov 18, 1993 Feb 16, 1989 Nov 18, 1993 Sep 20, 1990 Jul 20, 1989

HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

TABLET; ORAL HYZAAR MERCK AB 12.5MG;50MG AB 12.5MG;100MG AB + 25MG;100MG LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE APOTEX AB 12.5MG;50MG AB 12.5MG;100MG AB 25MG;100MG AUROBINDO PHARMA AB 12.5MG;50MG AB 12.5MG;100MG AB 25MG;100MG LUPIN LTD AB 12.5MG;50MG AB 12.5MG;100MG AB 25MG;100MG MYLAN AB 12.5MG;50MG AB 12.5MG;100MG AB 25MG;100MG ROXANE AB 12.5MG;50MG AB 12.5MG;100MG AB 25MG;100MG SANDOZ AB 12.5MG;50MG AB 12.5MG;100MG AB 25MG;100MG TEVA PHARMS AB 12.5MG;50MG AB 12.5MG;100MG AB 25MG;100MG

N020387 001 N020387 003 N020387 002 A090150 A090150 A090150 A091629 A091629 A091629 A078245 A078245 A078245 A091652 A091652 A091652 A077732 A077732 A077732 A077948 A077948 A077948 A077157 A077157 A077157 001 002 003 001 002 003 001 002 003 001 002 003 002 001 003 001 003 002 001 002 003

Apr 28, 1995 Oct 20, 2005 Nov 10, 1998 Oct Aug Oct Oct Oct Jan Oct May Oct Oct Apr Oct Oct Apr Oct Oct Aug Oct Apr Apr Apr 06, 11, 06, 06, 06, 06, 06, 21, 06, 06, 06, 06, 06, 06, 06, 06, 19, 06, 06, 06, 06, 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
TABLET; ORAL LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TORRENT PHARMS AB 12.5MG;50MG AB 12.5MG;100MG AB 25MG;100MG WATSON LABS AB 12.5MG;50MG AB 12.5MG;100MG AB 25MG;100MG ZYDUS PHARMS USA INC 12.5MG;50MG AB AB 25MG;100MG

3 - 217 (of 424)

A090528 A090528 A090528 A200180 A200180 A200180 A078385 A078385

001 003 002 001 002 003 001 002

Oct Apr Oct Jan Jan Jan Oct Oct

06, 06, 06, 12, 12, 12, 06, 06,

2010 2010 2010 2011 2011 2011 2010 2010

HYDROCHLOROTHIAZIDE; METHYLDOPA
TABLET; ORAL METHYLDOPA AND HYDROCHLOROTHIAZIDE MYLAN 15MG;250MG XX 25MG;250MG XX +

A070264 001 A070265 001

Jan 23, 1986 Jan 23, 1986

HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE

TABLET; ORAL LOPRESSOR HCT NOVARTIS AB 25MG;50MG AB + 25MG;100MG METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE MYLAN AB 25MG;50MG AB 25MG;100MG METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE MYLAN 50MG;100MG XX

N018303 001 N018303 002 A076792 001 A076792 002 A076792 003

Dec 31, 1984 Dec 31, 1984 Aug 20, 2004 Aug 20, 2004 Aug 20, 2004

HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE

TABLET; ORAL MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE GLENMARK PHARMS AB 12.5MG;7.5MG AB 12.5MG;15MG AB 25MG;15MG PADDOCK LLC AB 12.5MG;7.5MG AB 12.5MG;15MG AB 25MG;15MG TEVA AB 12.5MG;7.5MG AB 12.5MG;15MG AB 25MG;15MG UNIRETIC UCB INC AB 12.5MG;7.5MG AB 12.5MG;15MG AB + 25MG;15MG

A090718 A090718 A090718 A090096 A090096 A090096 A076980 A076980 A076980

001 002 003 001 002 003 001 003 002

Mar Mar Mar Sep Sep Sep Mar Mar Mar

17, 17, 17, 25, 25, 25, 07, 07, 07,

2010 2010 2010 2008 2008 2008 2007 2007 2007

N020729 001 N020729 003 N020729 002

Jun 27, 1997 Feb 14, 2002 Jun 27, 1997

HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

TABLET; ORAL BENICAR HCT XX DAIICHI SANKYO XX XX +

12.5MG;20MG 12.5MG;40MG 25MG;40MG

N021532 002 N021532 003 N021532 005

Jun 05, 2003 Jun 05, 2003 Jun 05, 2003

HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE

TABLET; ORAL INDERIDE-40/25 AB + AKRIMAX PHARMS 25MG;40MG PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE MYLAN AB 25MG;40MG AB + 25MG;80MG

N018031 001 A070946 001 A070947 001

Mar 04, 1987

Apr 01, 1987

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE
TABLET; ORAL PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE PLIVA AB 25MG;40MG AB 25MG;80MG WATSON LABS AB 25MG;40MG AB 25MG;80MG

3 - 218 (of 424)

A072042 A072043 A070301 A070305

001 001 001 001

Mar Mar Apr Apr

14, 14, 18, 18,

1988 1988 1986 1986

HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE

TABLET; ORAL ACCURETIC PFIZER PHARMS AB AB AB + QUINAPRIL HYDROCHLORIDE AUROBINDO PHARMA AB AB AB INVAGEN PHARMS AB AB AB MYLAN AB AB AB RANBAXY AB AB AB QUINARETIC GAVIS PHARMS AB AB AB

12.5MG;EQ 10MG BASE 12.5MG;EQ 20MG BASE 25MG;EQ 20MG BASE AND HYDROCHLOROTHIAZIDE 12.5MG;EQ 10MG BASE 12.5MG;EQ 20MG BASE 25MG;EQ 20MG BASE 12.5MG;10MG 12.5MG;20MG 25MG;20MG 12.5MG;EQ 10MG BASE 12.5MG;EQ 20MG BASE 25MG;EQ 20MG BASE 12.5MG;EQ 10MG BASE 12.5MG;EQ 20MG BASE 25MG;EQ 20MG BASE 12.5MG;EQ 10MG BASE 12.5MG;EQ 20MG BASE 25MG;EQ 20MG BASE

N020125 001 N020125 002 N020125 003 A078450 A078450 A078450 A201356 A201356 A201356 A077093 A077093 A077093 A078211 A078211 A078211 001 002 003 001 002 003 001 002 003 001 002 003

Dec 28, 1999 Dec 28, 1999 Dec 28, 1999 Aug Aug Aug Apr Apr Apr Mar Mar Mar Mar Mar Mar 24, 24, 24, 20, 20, 20, 28, 28, 28, 04, 04, 04, 2007 2007 2007 2011 2011 2011 2005 2005 2005 2009 2009 2009

A076374 001 A076374 002 A076374 003

Mar 31, 2004 Mar 31, 2004 Mar 31, 2004

HYDROCHLOROTHIAZIDE; SPIRONOLACTONE
TABLET; ORAL ALDACTAZIDE GD SEARLE LLC 25MG;25MG SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE MUTUAL PHARM 25MG;25MG MYLAN 25MG;25MG WATSON LABS 25MG;25MG ALDACTAZIDE + GD SEARLE LLC 50MG;50MG

AB AB AB AB XX

N012616 004 A089534 001 A086513 001 A087398 001 N012616 005

Dec 30, 1982 Jul 02, 1987

Dec 30, 1982

HYDROCHLOROTHIAZIDE; TELMISARTAN
TABLET; ORAL MICARDIS HCT BOEHRINGER INGELHEIM XX XX XX +

12.5MG;40MG 12.5MG;80MG 25MG;80MG

N021162 001 N021162 002 N021162 003

Nov 17, 2000 Nov 17, 2000 Apr 19, 2004

HYDROCHLOROTHIAZIDE; TRIAMTERENE
CAPSULE; ORAL DYAZIDE + GLAXOSMITHKLINE LLC 25MG;37.5MG TRIAMTERENE AND HYDROCHLOROTHIAZIDE DURAMED PHARMS BARR 25MG;37.5MG IVAX SUB TEVA PHARMS 25MG;50MG LANNETT HOLDINGS INC 25MG;37.5MG MYLAN 25MG;37.5MG SANDOZ 25MG;37.5MG

AB AB AB AB AB AB

N016042 003 A075052 A074259 A201407 A074701 A074821 001 001 001 001 001

Mar 03, 1994 Jun Mar Dec Jun Jun 18, 30, 09, 07, 05, 1999 1995 2011 1996 1997

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

HYDROCHLOROTHIAZIDE; TRIAMTERENE
CAPSULE; ORAL TRIAMTERENE AND HYDROCHLOROTHIAZIDE AB + SANDOZ 25MG;50MG TABLET; ORAL MAXZIDE AB + MYLAN BERTEK 50MG;75MG MAXZIDE-25 MYLAN BERTEK AB 25MG;37.5MG TRIAMTERENE AND HYDROCHLOROTHIAZIDE APOTEX INC AB 25MG;37.5MG AB 50MG;75MG PLIVA AB 25MG;37.5MG AB 50MG;75MG SANDOZ AB 25MG;37.5MG AB 50MG;75MG WATSON LABS AB 25MG;37.5MG AB 50MG;75MG AB 50MG;75MG

3 - 219 (of 424)

A073191 001

Jul 31, 1991

N019129 001 N019129 003 A071251 A071251 A074026 A073467 A073281 A072011 A073449 A071851 A071969 002 001 001 001 001 001 001 001 001

Oct 22, 1984 May 13, 1988 May Apr Apr Jan Apr Jun Sep Nov Apr 05, 17, 26, 31, 30, 17, 23, 30, 17, 1998 1988 1996 1996 1992 1988 1993 1988 1988

HYDROCHLOROTHIAZIDE; VALSARTAN
TABLET; ORAL DIOVAN HCT NOVARTIS XX XX XX XX XX +

12.5MG;80MG 12.5MG;160MG 12.5MG;320MG 25MG;160MG 25MG;320MG

N020818 N020818 N020818 N020818 N020818

001 002 004 003 005

Mar Mar Apr Jan Apr

06, 06, 28, 17, 28,

1998 1998 2006 2002 2006

HYDROCODONE BITARTRATE; IBUPROFEN

TABLET; ORAL HYDROCODONE BITARTRATE AND IBUPROFEN AMNEAL PHARMS NY AB 5MG;200MG AB 7.5MG;200MG TEVA AB 7.5MG;200MG VINTAGE PHARMS AB 5MG;200MG AB 7.5MG;200MG AB 10MG;200MG WATSON LABS FLORIDA AB 5MG;200MG AB 7.5MG;200MG VICOPROFEN AB + ABBOTT 7.5MG;200MG REPREXAIN AMNEAL PHARMS NY 2.5MG;200MG XX 10MG;200MG XX

A076642 A076642 A076023 A077727 A077723 A077723 A077454 A076604

002 001 001 001 001 002 001 001

Mar Oct Apr Nov Nov Nov Jun Dec

18, 12, 11, 06, 06, 06, 23, 31,

2004 2004 2003 2006 2006 2006 2010 2003

N020716 001 A076642 003 A076642 004

Sep 23, 1997 Oct 19, 2007 Oct 19, 2007

HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE

SOLUTION; ORAL

REZIRA

XX + CYPRESS PHARM

5MG/5ML;60MG/5ML

N022442 001

Jun 08, 2011

HYDROCORTISONE
CREAM; TOPICAL ALA-CORT CROWN LABS AT ANUSOL HC SALIX PHARMS AT HYDROCORTISONE ACTAVIS MID ATLANTIC AT AT

1% 2.5% 1% 2.5%

A080706 006 A088250 001 A087795 001 A089682 001 Jun 06, 1984 May 03, 1983 Mar 10, 1988

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

HYDROCORTISONE
CREAM; TOPICAL HYDROCORTISONE + FOUGERA + LYNE PERRIGO NEW YORK TARO VINTAGE PHARMS SYNACORT MEDICIS

3 - 220 (of 424)

AT AT AT AT AT AT AT AT AT

1% 2.5% 2.5% 2.5% 1% 2.5% 2.5% 1% 2.5%

A080693 A089414 A040879 A085025 A086155 A088799 A040503

003 001 001 001 001 001 001

Dec 16, 1986 Aug 20, 2010

Nov 09, 1984 Mar 12, 2004

A087458 001 A087457 001

ENEMA; RECTAL COLOCORT PADDOCK LLC AB CORTENEMA AB + ANI PHARMS HYDROCORTISONE TEVA PHARMS AB LOTION; TOPICAL ALA-CORT CROWN LABS HYDROCORTISONE + ALTANA TARO VINTAGE PHARMS NUTRACORT CORIA STIE-CORT PERRIGO ALA-SCALP

CROWN LABS OINTMENT; TOPICAL HYDROCORTISONE ACTAVIS MID ATLANTIC + ALTANA + FOUGERA PERRIGO NEW YORK TARO

100MG/60ML 100MG/60ML 100MG/60ML

A075172 001 N016199 001 A074171 001

Dec 03, 1999

May 27, 1994

AT AT AT AT AT AT AT AT XX

1% 2.5% 2.5% 2.5% 1% 2.5% 1% 2.5% 2%

A083201 001 A040351 001 A040247 001 A040417 001 A080443 003 A087644 001 A089066 001 A089074 001 A083231 001

Jul 25, 2000 Jul 23, 1999 Jul 30, 2003

Aug 24, 1982 Nov 25, 1985 Nov 26, 1985

AT AT AT AT AT AT AT

1% 1% 2.5% 2.5% 1% 2.5% HYDROCORTISONE IN ABSORBASE CAROLINA MEDCL 1%

A087796 A080692 A081203 A085027 A086257 A040310

001 001 001 001 001 001

Oct 13, 1982 May 28, 1993

Dec 29, 2000 Sep 06, 1985

A088138 001

POWDER; FOR RX COMPOUNDING

HYDRO-RX

100% XX + X GEN PHARMS SOLUTION; TOPICAL

TEXACORT

XX + MISSION PHARMA TABLET; ORAL CORTEF PHARMACIA AND UPJOHN AB AB AB + HYDROCORTISONE COREPHARMA AB AB

A085982 001

2.5%

A081271 001

Apr 17, 1992

5MG 10MG 20MG 5MG 10MG

N008697 003 N008697 001 N008697 002 A040646 001 A040646 002 Mar 30, 2007 Mar 30, 2007

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

HYDROCORTISONE
TABLET; ORAL HYDROCORTISONE COREPHARMA AB VINTAGE AB AB AB HYDROCORTISONE BP WEST WARD

3 - 221 (of 424)

20MG 5MG 10MG 20MG 20MG

A040646 A040761 A040761 A040761

003 001 002 003

Mar Jul Jul Jul

30, 16, 16, 16,

2007 2007 2007 2007

A083365 001

HYDROCORTISONE ACETATE
AEROSOL, METERED; RECTAL

CORTIFOAM

XX + MEDA PHARMS

10%

N017351 001

Feb 10, 1982

CREAM; TOPICAL

HYDROCORTISONE ACETATE

2.5%
XX + FERNDALE LABS MICORT-HC
2%
XX + FERNDALE LABS 2.5%
XX PASTE; TOPICAL

ORABASE HCA

COLGATE XX

A040259 001 A040398 001 A040396 001

Jul 29, 1999 Mar 29, 2002 Feb 27, 2001

0.5%

A083205 001

POWDER; FOR RX COMPOUNDING

HYDROCORTISONE ACETATE

X GEN PHARMS 100%
XX

A085981 001

HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

CREAM; TOPICAL

CORTISPORIN

XX + MONARCH PHARMS

0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM

N050218 001

Aug 09, 1985

HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE

AEROSOL, METERED; TOPICAL EPIFOAM BX MEDA PHARMS 1%;1% PROCTOFOAM HC BX MEDA PHARMS 1%;1%
CREAM; TOPICAL

PRAMOSONE
FERNDALE LABS XX XX
LOTION; TOPICAL

PRAMOSONE
FERNDALE LABS XX XX

A086457 001 A086195 001

0.5%;1%
1%;1%

A083778 001
A085368 001

1%;1%
2.5%;1%

A085980 001
A085979 001

HYDROCORTISONE ACETATE; UREA

CREAM; TOPICAL CARMOL HC NYCOMED US AT U-CORT TARO AT

1%;10% 1%;10%

A080505 001 A089472 001 Jun 13, 1988

HYDROCORTISONE BUTYRATE
CREAM; TOPICAL HYDROCORTISONE BUTYRATE TARO PHARM INDS AB 0.1%

A076654 001

Aug 03, 2005

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

HYDROCORTISONE BUTYRATE
CREAM; TOPICAL LOCOID AB + TRIAX PHARMS LLC LOCOID LIPOCREAM XX + TRIAX PHARMS LLC LOTION; TOPICAL

LOCOID

XX + TRIAX PHARMS LLC

3 - 222 (of 424)

0.1% 0.1%

N018514 001 N020769 001

Mar 31, 1982 Sep 08, 1997

0.1%

N022076 001

May 18, 2007

OINTMENT; TOPICAL HYDROCORTISONE BUTYRATE TARO AB 0.1% LOCOID AB + TRIAX PHARMS LLC 0.1% SOLUTION; TOPICAL HYDROCORTISONE BUTYRATE TARO PHARM INDS AT 0.1% LOCOID AT + TRIAX PHARMS LLC 0.1%

A076842 001 N018652 001

Dec 27, 2004 Oct 29, 1982

A076364 001 N019116 001

Jan 14, 2004 Feb 25, 1987

HYDROCORTISONE PROBUTATE

CREAM; TOPICAL

PANDEL
XX + FOUGERA PHARMS

0.1%

N020453 001

Feb 28, 1997

HYDROCORTISONE SODIUM SUCCINATE

INJECTABLE; INJECTION A-HYDROCORT HOSPIRA SOLU-CORTEF + PHARMACIA AND UPJOHN + + +

AP AP AP AP AP

EQ 100MG BASE/VIAL EQ EQ EQ EQ 100MG BASE/VIAL 250MG BASE/VIAL 500MG BASE/VIAL 1GM BASE/VIAL

A040666 001 N009866 N009866 N009866 N009866 001 002 003 004

Apr 06, 2006

HYDROCORTISONE VALERATE
CREAM; TOPICAL HYDROCORTISONE VALERATE PERRIGO NEW YORK AB 0.2% TARO AB 0.2% WESTCORT AB + RANBAXY 0.2% OINTMENT; TOPICAL HYDROCORTISONE VALERATE ALTANA AB 0.2% TARO AB 0.2% WESTCORT AB + RANBAXY 0.2%

A075666 001 A075042 001 N017950 001

May 24, 2000 Aug 25, 1998

A075085 001 A075043 001 N018726 001

Jul 31, 2001 Aug 25, 1998 Aug 08, 1983

HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

SOLUTION/DROPS; OTIC CORTISPORIN + MONARCH PHARMS 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE ALCON 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML BAUSCH AND LOMB 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML LUITPOLD 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML

AT AT AT AT

N050479 001 A062423 001 A064053 001 A065216 001 Aug 25, 1983 Dec 29, 1995 Oct 31, 2005

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
SUSPENSION/DROPS; OPHTHALMIC
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
XX + ALCON UNIVERSAL 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML SUSPENSION/DROPS; OTIC CORTISPORIN + MONARCH PHARMS 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE ALCON UNIVERSAL 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML LUITPOLD 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML OTICAIR BAUSCH AND LOMB 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML PEDIOTIC MONARCH PHARMS 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML

3 - 223 (of 424)

A062874 001

May 11, 1988

AT AT AT AT AT

A060613 001 A062488 001 A065219 001 A064065 001 A062822 001 Nov 06, 1985 May 01, 2006 Aug 28, 1996 Sep 29, 1987

HYDROFLUMETHIAZIDE
TABLET; ORAL SALURON AB + SHIRE

50MG

N011949 001

HYDROMORPHONE HYDROCHLORIDE
INJECTABLE; INJECTION DILAUDID + PURDUE PHARM PRODS 1MG/ML 2MG/ML + 4MG/ML + DILAUDID-HP + PURDUE PHARM PRODS 10MG/ML HYDROMORPHONE HYDROCHLORIDE AKORN 10MG/ML 10MG/ML BARR 10MG/ML HOSPIRA 10MG/ML HOSPIRA INC 1MG/ML 2MG/ML 4MG/ML 10MG/ML DILAUDID-HP + PURDUE PHARM PRODS 250MG/VIAL

AP AP AP AP AP AP AP AP AP AP AP AP XX

N019034 003 N019034 004 N019034 005 N019034 001 A078228 A078261 A076444 A074598 N200403 N200403 N200403 A078591 001 001 001 001 001 002 003 001

Apr 30, 2009 Apr 30, 2009 Apr 30, 2009 Jan 11, 1984 Apr Apr Apr Jun Dec Dec Dec Jun 14, 14, 25, 19, 01, 01, 01, 17, 2010 2010 2003 1997 2011 2011 2011 2008

N019034 002

Aug 04, 1994

SOLUTION; ORAL DILAUDID AA + PURDUE PHARM PRODS 5MG/5ML HYDROMORPHONE HYDROCHLORIDE ROXANE AA 5MG/5ML TABLET; ORAL DILAUDID PURDUE PHARM PRODS AB 2MG AB 4MG AB + 8MG HYDROMORPHONE HYDROCHLORIDE ELITE LABS 8MG AB LANNETT 2MG AB 4MG AB 8MG AB MALLINCKRODT 8MG AB MALLINCKRODT INC 2MG AB 4MG AB NESHER PHARMS 2MG AB 4MG AB 8MG AB

N019891 001 A074653 001

Dec 07, 1992 Jul 29, 1998

N019892 003 N019892 002 N019892 001 A076723 A078439 A078439 A077471 A076855 A078273 A078273 A077311 A077311 A077311 001 001 002 001 001 001 002 001 002 003

Nov 09, 2007 Nov 09, 2007 Dec 07, 1992 Oct Dec Dec Dec Dec Sep Sep Nov Nov Nov 18, 09, 09, 09, 23, 19, 19, 09, 09, 09, 2005 2009 2009 2009 2004 2007 2007 2005 2005 2005

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

HYDROMORPHONE HYDROCHLORIDE
TABLET; ORAL HYDROMORPHONE HYDROCHLORIDE ROXANE AB 4MG AB 8MG TABLET, EXTENDED RELEASE; ORAL EXALGO MALLINCKRODT INC 8MG XX 12MG XX 16MG XX +

3 - 224 (of 424)

A074597 003 A074597 001

May 29, 2009 Jul 29, 1998

N021217 001 N021217 002 N021217 003

Mar 01, 2010 Mar 01, 2010 Mar 01, 2010

HYDROXOCOBALAMIN
INJECTABLE; INJECTION

CYANOKIT

XX + MERCK SANTE SAS HYDROXOCOBALAMIN XX + WATSON LABS

5GM/VIAL (5GM/KIT) 1MG/ML

N022041 001 A085998 001

Apr 08, 2011

HYDROXYAMPHETAMINE HYDROBROMIDE; TROPICAMIDE

SOLUTION/DROPS; OPHTHALMIC
PAREMYD
XX + AKORN 1%;0.25%

N019261 001

Jan 30, 1992

HYDROXYCHLOROQUINE SULFATE
TABLET; ORAL HYDROXYCHLOROQUINE SULFATE IPCA LABS LTD AB 200MG MYLAN AB 200MG SANDOZ AB 200MG AB 200MG TEVA PHARMS AB 200MG WATSON LABS AB 200MG WEST WARD AB 200MG ZYDUS PHARMS USA INC 200MG AB PLAQUENIL AB + SANOFI AVENTIS US 200MG

A040766 A040274 A040104 A040150 A040081 A040133 A040760 A040657

001 001 001 001 001 001 001 001

Jun May Nov Jan Sep Nov Aug Sep

14, 29, 30, 27, 30, 30, 15, 21,

2007 1998 1995 1996 1994 1995 2007 2007

N009768 001

HYDROXYPROGESTERONE CAPROATE

SOLUTION; INTRAMUSCULAR

MAKENA
XX + KV PHARM

1250MG/5ML (250MG/ML)

N021945 001

Feb 03, 2011

HYDROXYPROPYL CELLULOSE
INSERT; OPHTHALMIC

LACRISERT

XX + ATON

5MG

N018771 001

HYDROXYUREA
CAPSULE; ORAL HYDREA + BRISTOL MYERS SQUIBB HYDROXYUREA BARR PAR PHARM DROXIA BRISTOL MYERS SQUIBB

AB AB AB XX XX XX

500MG 500MG 500MG 200MG 300MG 400MG

N016295 001 A075143 001 A075340 001 N016295 002 N016295 003 N016295 004 Oct 16, 1998 Feb 24, 1999 Feb 25, 1998 Feb 25, 1998 Feb 25, 1998

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

HYDROXYZINE HYDROCHLORIDE
INJECTABLE; INJECTION HYDROXYZINE HYDROCHLORIDE + APP PHARMS 25MG/ML + 50MG/ML LUITPOLD 25MG/ML 50MG/ML

3 - 225 (of 424)

AP AP AP AP

A087329 A087329 A087408 A087408

001 002 001 002

SYRUP; ORAL HYDROXYZINE HYDROCHLORIDE AA + HI TECH PHARMA 10MG/5ML AA + VINTAGE PHARMS 10MG/5ML AA + WOCKHARDT 10MG/5ML TABLET; ORAL HYDROXYZINE HYDROCHLORIDE AMNEAL PHARM 10MG 25MG 50MG HERITAGE PHARMS INC 10MG 25MG 50MG HETERO LABS UNIT III 10MG 25MG 50MG INVAGEN PHARMS 10MG 25MG 50MG KVK TECH 10MG 25MG 50MG MUTUAL PHARM 10MG 25MG 50MG MYLAN 10MG 25MG 50MG NORTHSTAR HLTHCARE 10MG 25MG 50MG + PLIVA 10MG + 25MG + 50MG SUN PHARM INDS INC 10MG 25MG 50MG VINTAGE PHARMS 10MG 25MG 50MG WATSON LABS 10MG 10MG 25MG 25MG 50MG 50MG

A040010 001 A040391 001 A087294 001

Oct 28, 1994 Apr 10, 2002 Apr 12, 1982

AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB

A040808 A040808 A040808 A040804 A040804 A040804 A040805 A040805 A040805 A040812 A040812 A040812 A040786 A040787 A040788 A089381 A089382 A089383 A091176 A091176 A091176 A040841 A040842 A040840 A088617 A088618 A088619 A040899 A040899 A040899 A040579 A040574 A040580 A081149 A088348 A081150 A088349 A081151 A088350

001 002 003 001 002 003 001 002 003 001 002 003 001 001 001 001 001 001 001 002 003 001 001 001 001 001 001 001 002 003 001 001 001 001 001 001 001 001 001

Sep Sep Sep Jun Jun Jun May May May Mar Mar Mar Mar Mar Mar May May May Jun Jun Jun Mar Mar Mar Jan Jan Jan Jun Jun Jun May May May Mar Sep Mar Sep Mar Sep

24, 24, 24, 30, 30, 30, 29, 29, 29, 12, 12, 12, 20, 20, 20, 19, 19, 19, 07, 07, 07, 31, 31, 31, 10, 10, 10, 10, 10, 10, 27, 27, 27, 18, 15, 18, 15, 18, 15,

2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2007 2007 2007 1986 1986 1986 2010 2010 2010 2008 2008 2008 1986 1986 1986 2008 2008 2008 2005 2005 2005 1994 1983 1994 1983 1994 1983

HYDROXYZINE PAMOATE
CAPSULE; ORAL HYDROXYZINE PAMOATE BARR AB AB SANDOZ AB

EQ 25MG HCL EQ 50MG HCL EQ 25MG HCL

A088496 001 A088487 001 A087479 001

Jun 15, 1984 Jun 15, 1984

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

HYDROXYZINE PAMOATE
CAPSULE; ORAL HYDROXYZINE PAMOATE SANDOZ AB WATSON LABS AB AB AB VISTARIL PFIZER AB AB + HYDROXYZINE PAMOATE BARR XX
SUSPENSION; ORAL

VISTARIL
XX + PFIZER

3 - 226 (of 424)

EQ EQ EQ EQ

50MG 25MG 25MG 50MG

HCL HCL HCL HCL

A086183 A040156 A081165 A040156

001 001 001 002

Jul 15, 1996 Jul 31, 1991 Jul 15, 1996

EQ 25MG HCL EQ 50MG HCL EQ 100MG HCL

N011459 002 N011459 004 A088488 001 Jun 15, 1984

EQ 25MG HCL/5ML

N011795 001

IBANDRONATE SODIUM

INJECTABLE; INTRAVENOUS

BONIVA
XX + ROCHE
TABLET; ORAL

BONIVA
XX + ROCHE

EQ 3MG BASE/3ML

N021858 001

Jan 06, 2006

EQ 150MG BASE

N021455 002

Mar 24, 2005

IBUPROFEN
SOLUTION; INTRAVENOUS CALDOLOR CUMBERLAND PHARMS XX XX + SUSPENSION; ORAL IBUPROFEN AB + ACTAVIS MID ATLANTIC PERRIGO R AND D AB TABLET; ORAL IBUPROFEN AMNEAL PHARMS NY AB AB AB AB AB AB CONTRACT PHARMACAL AB AB AB DR REDDYS LA AB AB AB + DR REDDYS LABS INC AB AB AB MARKSANS PHARMA AB AB AB NORTHSTAR HLTHCARE AB AB AB OHM LABS AB PERRIGO R AND D AB AB

400MG/4ML (100MG/ML) 800MG/8ML (100MG/ML)

N022348 001 N022348 002

Jun 11, 2009 Jun 11, 2009

100MG/5ML 100MG/5ML

A074978 001 A076925 001

Mar 25, 1998 Sep 23, 2004

400MG 400MG 600MG 600MG 800MG 800MG 400MG 600MG 800MG 400MG 600MG 800MG 400MG 600MG 800MG 400MG 600MG 800MG 400MG 600MG 800MG 400MG 400MG 600MG

A071334 A078558 A071335 A078558 A071935 A078558 A071267 A071268 A072300 A075682 A075682 A075682 A076112 A076112 A076112 A090796 A090796 A090796 A078132 A078132 A078132 A070818 A077114 A077114

001 001 001 002 001 003 001 001 001 001 002 003 001 002 003 001 002 003 001 002 003 001 001 002

Nov Jun Nov Jun Oct Jun Oct Oct Jul Nov Nov Nov Oct Oct Oct Dec Dec Dec Sep Sep Sep Dec Jul Jul

25, 18, 25, 18, 13, 18, 15, 15, 01, 14, 14, 14, 31, 31, 31, 21, 21, 21, 10, 10, 10, 26, 18, 18,

1986 2007 1986 2007 1987 2007 1986 1986 1988 2001 2001 2001 2001 2001 2001 2010 2010 2010 2007 2007 2007 1985 2005 2005

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

IBUPROFEN
TABLET; ORAL IBUPROFEN PERRIGO R AND D AB SHASUN USA AB AB AB VINTAGE PHARMS AB AB AB AB AB WATSON LABS AB AB IBU-TAB ALRA AB AB

3 - 227 (of 424)

800MG 400MG 600MG 800MG 300MG 400MG 400MG 600MG 800MG 400MG 600MG 400MG 600MG

A077114 A078329 A078329 A078329 A071230 A071231 A071644 A071232 A072004 A070436 A070437

003 001 002 003 001 001 001 001 001 001 001

Jul Feb Feb Feb Oct Oct Feb Oct Nov Aug Aug

18, 05, 05, 05, 22, 22, 01, 22, 18, 21, 21,

2005 2009 2009 2009 1986 1986 1988 1986 1987 1985 1985

A071058 001 A071059 001

Aug 11, 1988 Aug 11, 1988

IBUPROFEN LYSINE
INJECTABLE; INTRAVENOUS
NEOPROFEN
XX + LUNDBECK INC

EQ 20MG BASE/2ML (EQ 10MG BASE/ML)

N021903 001

Apr 13, 2006

IBUPROFEN; OXYCODONE HYDROCHLORIDE

TABLET; ORAL OXYCODONE HYDROCHLORIDE ACTAVIS ELIZABETH AB AB + BARR LABS INC WATSON LABS AB AND IBUPROFEN 400MG;5MG 400MG;5MG 400MG;5MG

A078769 001 A078316 001 A078394 001

Jan 04, 2008 Nov 29, 2007 Nov 26, 2007

IBUTILIDE FUMARATE
INJECTABLE; INJECTION CORVERT AP + PHARMACIA AND UPJOHN IBUTILIDE FUMARATE BIONICHE PHARMA USA AP AP LUITPOLD AP

0.1MG/ML 0.1MG/ML 0.1MG/ML 0.1MG/ML

N020491 001 A090643 001 A090924 001 A090240 001

Dec 28, 1995 Jan 11, 2010 Jan 11, 2010 Jan 11, 2010

ICATIBANT ACETATE
INJECTABLE; SUBCUTANEOUS
FIRAZYR
XX + SHIRE ORPHAN THERAP

EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

N022150 001

Aug 25, 2011

ICODEXTRIN
SOLUTION; INTRAPERITONEAL
EXTRANEAL
7.5GM/100ML XX + BAXTER HLTHCARE

N021321 001

Dec 20, 2002

IDARUBICIN HYDROCHLORIDE
INJECTABLE; INJECTION IDAMYCIN PFS + PHARMACIA AND UPJOHN 1MG/ML IDARUBICIN HYDROCHLORIDE APP PHARMS 1MG/ML BEDFORD LABS 1MG/ML 1MG/ML SANDOZ 1MG/ML

AP AP AP AP AP

N050734 001 A065440 A065275 A065288 A091293 001 001 001 001

Feb 17, 1997 Aug Dec May Mar 04, 14, 15, 29, 2009 2006 2007 2011

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

IDARUBICIN HYDROCHLORIDE
INJECTABLE; INJECTION IDARUBICIN HYDROCHLORIDE PFS TEVA PARENTERAL 1MG/ML IDARUBICIN HYDROCHLORIDE + TEVA PARENTERAL 5MG/VIAL + 10MG/VIAL + 20MG/VIAL

3 - 228 (of 424)

AP XX XX XX

A065036 001 A065037 003 A065037 002 A065037 001

May 01, 2002 May 01, 2002 May 01, 2002 May 01, 2002

IDOXURIDINE
SOLUTION/DROPS; OPHTHALMIC DENDRID AT + ALCON 0.1% HERPLEX AT + ALLERGAN 0.1%

N014169 001 N013935 002

IFOSFAMIDE
INJECTABLE; INJECTION IFEX BAXTER HLTHCARE AP AP IFOSFAMIDE AP + APP PHARMS AP AP + AP BEDFORD LABS AP AP AP + TEVA PARENTERAL AP +

1GM/VIAL 3GM/VIAL 1GM/VIAL 1GM/20ML (50MG/ML) 3GM/VIAL 3GM/60ML (50MG/ML) 1GM/20ML(50MG/ML) 3GM/60ML(50MG/ML) 1GM/20ML (50MG/ML) 3GM/60ML (50MG/ML)

N019763 001 N019763 002 A076078 A090181 A076078 A090181 A076619 A076619 A076657 A076657 001 001 002 002 001 002 001 002

Dec 30, 1988 Dec 30, 1988 May Sep May Sep Jun Jun Apr Apr 28, 22, 28, 22, 29, 29, 04, 04, 2002 2009 2002 2009 2011 2011 2007 2007

IFOSFAMIDE; MESNA

INJECTABLE; INTRAVENOUS

IFOSFAMIDE/MESNA KIT
XX + TEVA PARENTERAL XX +

1GM/20ML;1GM/10ML (50MG/ML;100MG/ML) 3GM/60ML;1GM/10ML (50MG/ML;100MG/ML)

A075874 001 A075874 002

Feb 26, 2002 Feb 26, 2002

ILOPERIDONE

TABLET; ORAL

FANAPT
XX + NOVARTIS XX XX XX XX XX XX

1MG 2MG 4MG 6MG 8MG 10MG 12MG

N022192 N022192 N022192 N022192 N022192 N022192 N022192

001 002 003 004 005 006 007

May May May May May May May

06, 06, 06, 06, 06, 06, 06,

2009 2009 2009 2009 2009 2009 2009

ILOPROST

SOLUTION; INHALATION

VENTAVIS
XX + ACTELION PHARMS LTD XX +

10MCG/ML (10MCG/ML) 20MCG/ML (20MCG/ML)

N021779 002 N021779 003

Dec 08, 2005 Aug 07, 2009

IMATINIB MESYLATE
TABLET; ORAL GLEEVEC NOVARTIS XX XX +

EQ 100MG BASE EQ 400MG BASE

N021588 001 N021588 002

Apr 18, 2003 Apr 18, 2003

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

IMIGLUCERASE
INJECTABLE; INJECTION CEREZYME GENZYME XX XX +

3 - 229 (of 424)

200 UNITS/VIAL 400 UNITS/VIAL

N020367 001 N020367 002

May 23, 1994 Sep 22, 1999

IMIPRAMINE HYDROCHLORIDE
TABLET; ORAL IMIPRAMINE HYDROCHLORIDE LUPIN LTD 10MG 25MG 50MG MUTUAL PHARM 10MG 25MG 50MG PAR PHARM 10MG 10MG 25MG SANDOZ 10MG 25MG 50MG TOFRANIL MALLINCKRODT INC 10MG 25MG + 50MG

AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB

A090443 A090442 A090441 A081048 A081049 A081050 A088292 A089422 A088262 A084936 A083745 A084937

001 001 001 001 001 001 001 001 001 002 001 001

Mar Mar Mar Jun Jun Jun Oct Jul Oct

11, 11, 11, 05, 05, 05, 21, 14, 21,

2010 2010 2010 1990 1990 1990 1983 1987 1983

A087844 001 A087845 001 A087846 001

May 22, 1984 May 22, 1984 May 22, 1984

IMIPRAMINE PAMOATE
CAPSULE; ORAL IMIPRAMINE PAMOATE LUPIN LTD AB AB AB AB ROXANE AB AB AB AB TOFRANIL-PM AB + MALLINCKRODT INC AB AB AB

EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ

75MG HCL 100MG HCL 125MG HCL 150MG HCL 75MG HCL 100MG HCL 125MG HCL 150MG HCL 75MG HCL 100MG HCL 125MG HCL 150MG HCL

A090444 A090444 A090444 A090444 A091099 A091099 A091099 A091099 N017090 N017090 N017090 N017090

001 002 003 004 001 002 003 004 001 004 003 002

Apr Apr Apr Apr Apr Apr Apr Apr

16, 16, 16, 16, 16, 16, 16, 16,

2010 2010 2010 2010 2010 2010 2010 2010

IMIQUIMOD
CREAM; TOPICAL ALDARA + MEDICIS IMIQUIMOD NYCOMED US PERRIGO ISRAEL TARO TEVA PHARMS USA TOLMAR ZYCLARA + MEDICIS +

AB AB AB AB AB AB XX XX

5% 5% 5% 5% 5% 5% 2.5% 3.75%

N020723 001 A078548 A078837 A200173 A200481 A091044 001 001 001 001 001

Feb 27, 1997 Feb Sep Apr Apr Feb 25, 07, 15, 18, 28, 2010 2010 2011 2011 2011

N022483 002 N022483 001

Jul 15, 2011 Mar 25, 2010

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

INAMRINONE LACTATE
INJECTABLE; INJECTION

AMRINONE LACTATE

XX + BEDFORD

3 - 230 (of 424)

EQ 5MG BASE/ML

A075513 001

May 09, 2000

INDACATEROL MALEATE
POWDER; INHALATION

ARCAPTA NEOHALER

XX + NOVARTIS

EQ 75MCG BASE

N022383 001

Jul 01, 2011

INDAPAMIDE
TABLET; ORAL INDAPAMIDE ACTAVIS ELIZABETH AB AB ALPHAPHARM AB AB IVAX SUB TEVA PHARMS AB AB MYLAN AB AB + SANDOZ AB AB WATSON LABS AB AB

1.25MG 2.5MG 1.25MG 2.5MG 1.25MG 2.5MG 1.25MG 2.5MG 1.25MG 2.5MG 1.25MG 2.5MG

A074722 A074722 A075105 A075105 A074299 A074299 A074461 A074461 A074594 A074594 A074585 A074585

001 002 001 002 002 001 002 001 001 002 001 002

Jun Jun Jul Jul Apr Jul Mar Mar May May Sep Sep

17, 17, 23, 23, 29, 27, 26, 27, 23, 23, 26, 26,

1996 1996 1998 1998 1996 1995 1997 1996 1996 1996 1996 1996

INDINAVIR SULFATE
CAPSULE; ORAL CRIXIVAN MERCK SHARP DOHME XX XX XX +

EQ 100MG BASE EQ 200MG BASE EQ 400MG BASE

N020685 006 N020685 003 N020685 001

Apr 19, 2000 Mar 13, 1996 Mar 13, 1996

INDIUM IN-111 CHLORIDE

INJECTABLE; INJECTION

INDICLOR

XX + GE HEALTHCARE INDIUM IN 111 CHLORIDE XX + MALLINCKRODT

2mCi/0.2ML 5mCi/0.5ML

N019862 001 N019841 001

Dec 29, 1992 Sep 27, 1994

INDIUM IN-111 OXYQUINOLINE

INJECTABLE; INJECTION

INDIUM IN-111 OXYQUINOLINE

1mCi/ML XX + GE HEALTHCARE

N019044 001

Dec 24, 1985

INDIUM IN-111 PENTETATE DISODIUM

INJECTABLE; INTRATHECAL

MPI INDIUM DTPA IN 111
1mCi/ML XX + GE HEALTHCARE

N017707 001

Feb 18, 1982

INDIUM IN-111 PENTETREOTIDE KIT

INJECTABLE; INJECTION

OCTREOSCAN
XX + MALLINCKRODT

3mCi/ML

N020314 001

Jun 02, 1994

INDOCYANINE GREEN
INJECTABLE; INJECTION IC-GREEN AP + AKORN

25MG/VIAL

N011525 001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

INDOCYANINE GREEN
INJECTABLE; INJECTION INDOCYANINE GREEN PULSION MEDCL AP

3 - 231 (of 424)

25MG/VIAL

A040811 001

Nov 21, 2007

INDOMETHACIN
CAPSULE; ORAL INDOMETHACIN GLENMARK GENERICS AB AB HERITAGE PHARMS INC AB AB HETERO LABS UNIT III AB AB IVAX SUB TEVA PHARMS AB AB MYLAN AB AB + SANDOZ AB AB ZYDUS PHARMS USA INC AB AB

25MG 50MG 25MG 50MG 25MG 50MG 25MG 50MG 25MG 50MG 25MG 50MG 25MG 50MG

A091276 A091276 N018851 N018851 A091240 A091240 A070719 A070756 N018858 A070624 A070673 A070674 A090403 A090403

001 002 001 002 001 002 001 001 001 001 001 001 001 002

Dec Dec May May Apr Apr Feb Feb Apr Sep Apr Apr Nov Nov

22, 22, 18, 18, 12, 12, 12, 12, 20, 04, 29, 29, 15, 15,

2010 2010 1984 1984 2011 2011 1986 1986 1984 1985 1987 1987 2010 2010

AB AB AB AB

CAPSULE, EXTENDED RELEASE; ORAL INDOMETHACIN AMNEAL PHARMS 75MG AVANTHI INC 75MG PADDOCK LLC 75MG + SANDOZ 75MG

A091549 A079175 A200529 A074464

001 001 001 001

Dec Mar Nov May

01, 06, 30, 28,

2010 2009 2010 1998

INJECTABLE; INJECTION

INDOMETHACIN
XX + APP PHARMS
SUPPOSITORY; RECTAL

INDOMETHACIN
XX + G AND W LABS
SUSPENSION; ORAL

INDOCIN
XX + IROKO PHARMS

EQ 1MG BASE/VIAL

N022536 001

Mar 17, 2010

50MG

A073314 001

Aug 31, 1992

25MG/5ML

N018332 001

Oct 10, 1985

INDOMETHACIN SODIUM
INJECTABLE; INJECTION INDOCIN AP + LUNDBECK INC INDOMETHACIN SODIUM BEDFORD AP

EQ 1MG BASE/VIAL EQ 1MG BASE/VIAL

N018878 001 A078713 001

Jan 30, 1985 Jul 16, 2008

INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT

INJECTABLE; SUBCUTANEOUS

NOVOLOG MIX 70/30
XX + NOVO NORDISK INC

70 UNITS/ML;30 UNITS/ML

N021172 001

Nov 01, 2001

INSULIN ASPART RECOMBINANT

INJECTABLE; SUBCUTANEOUS

NOVOLOG

XX + NOVO NORDISK INC

100 UNITS/ML

N020986 001

Jun 07, 2000

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

INSULIN DETEMIR RECOMBINANT

INJECTABLE; SUBCUTANEOUS

LEVEMIR
XX + NOVO NORDISK INC

3 - 232 (of 424)

100 UNITS/ML

N021536 001

Jun 16, 2005

INSULIN GLARGINE RECOMBINANT

INJECTABLE; INJECTION

LANTUS

XX + SANOFI AVENTIS US

100 UNITS/ML

N021081 001

Apr 20, 2000

INSULIN GLULISINE RECOMBINANT

INJECTABLE; IV (INFUSION)-SC
APIDRA
XX + SANOFI AVENTIS US 1000 UNITS/10ML (100 UNITS/ML) XX + 300 UNITS/3ML (100 UNITS/ML) INJECTABLE; SUBCUTANEOUS APIDRA SOLOSTAR XX SANOFI AVENTIS US

N021629 001 N021629 002

Apr 16, 2004 Dec 20, 2005

300 UNITS/3ML

N021629 003

Feb 24, 2009

INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT

INJECTABLE; INJECTION

HUMALOG MIX 50/50

+ LILLY 50 HUMALOG MIX 50/50 KWIKPEN + LILLY 50 HUMALOG MIX 50/50 PEN + LILLY 50 HUMALOG MIX 75/25 + LILLY 75 HUMALOG MIX 75/25 KWIKPEN + LILLY 75 HUMALOG MIX 75/25 PEN + LILLY 75

XX XX XX XX XX XX

UNITS/ML;50 UNITS/ML UNITS/ML;50 UNITS/ML UNITS/ML;50 UNITS/ML UNITS/ML;25 UNITS/ML UNITS/ML;25 UNITS/ML UNITS/ML;25 UNITS/ML

N021018 001 N021018 002 N021018 003 N021017 001 N021017 002 N021017 003

Dec 22, 1999 Sep 06, 2007 Dec 22, 1999 Dec 22, 1999 Sep 06, 2007 Dec 22, 1999

INSULIN LISPRO RECOMBINANT

INJECTABLE; INJECTION

HUMALOG

XX + LILLY HUMALOG KWIKPEN XX + LILLY HUMALOG PEN XX + LILLY

100 UNITS/ML 100 UNITS/ML 100 UNITS/ML

N020563 001 N020563 003 N020563 002

Jun 14, 1996 Sep 06, 2007 Aug 06, 1998

INSULIN RECOMBINANT HUMAN

INJECTABLE; INJECTION

HUMULIN R

XX + LILLY

500 UNITS/ML

N018780 004

Mar 31, 1994

IOBENGUANE SULFATE I-123

SOLUTION; INTRAVENOUS

ADREVIEW

XX + GE HEALTHCARE

10MCI/5ML (2MCI/ML)

N022290 001

Sep 19, 2008

IODIPAMIDE MEGLUMINE
INJECTABLE; INJECTION

CHOLOGRAFIN MEGLUMINE

XX + BRACCO

52%

N009321 003

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

IODIXANOL

INJECTABLE; INJECTION

VISIPAQUE 270
XX + GE HEALTHCARE XX VISIPAQUE 320 XX + GE HEALTHCARE XX

3 - 233 (of 424)

55% 55% 65.2% 65.2%

N020351 001 N020808 001 N020351 002 N020808 002

Mar 22, 1996 Aug 29, 1997 Mar 22, 1996 Aug 29, 1997

IOFLUPANE I-123

SOLUTION; INTRAVENOUS

DATSCAN
XX + GE HLTHCARE INC

5MCI/2.5ML (2MCI/ML)

N022454 001

Jan 14, 2011

IOHEXOL

INJECTABLE; INJECTION

OMNIPAQUE 140
XX + GE HEALTHCARE

30.2%

N018956 005

Nov 30, 1988

SOLUTION; INJECTION, ORAL

OMNIPAQUE 350
XX + GE HEALTHCARE 75.5% XX 75.5%
SOLUTION; INJECTION, ORAL, RECTAL

OMNIPAQUE 180
XX + GE HEALTHCARE 38.8% OMNIPAQUE 240 XX + GE HEALTHCARE 51.8% XX 51.8% OMNIPAQUE 300 XX + GE HEALTHCARE 64.7% XX 64.7%

N018956 004 N020608 003

Dec 26, 1985 Oct 24, 1995

N018956 001 N018956 002 N020608 001 N018956 003 N020608 002

Dec 26, 1985 Dec 26, 1985 Oct 24, 1995 Dec 26, 1985 Oct 24, 1995

IOPAMIDOL
INJECTABLE; INJECTION IOPAMIDOL-250 APP PHARMS IOPAMIDOL-300 APP PHARMS IOPAMIDOL-370 APP PHARMS ISOVUE-200 + BRACCO ISOVUE-250 + BRACCO + ISOVUE-300 + BRACCO + ISOVUE-370 + BRACCO + SCANLUX-300 SANOCHEMIA CORP USA SCANLUX-370 SANOCHEMIA CORP USA ISOVUE-M 200 + BRACCO ISOVUE-M 300 + BRACCO

AP AP AP AP AP AP AP AP AP AP AP AP XX XX

51% 61% 76% 41% 51% 51% 61% 61% 76% 76% 61% 76% 41% 61%

A074679 001 A074679 002 A074679 003 N018735 006 N018735 007 N020327 002 N018735 002 N020327 003 N018735 003 N020327 004 A090394 001 A090394 002 N018735 001 N018735 004

Apr 02, 1997 Apr 02, 1997 Apr 02, 1997 Jul 07, 1987 Jul 06, 1992 Oct 12, 1994 Dec 31, 1985 Oct 12, 1994 Dec 31, 1985 Oct 12, 1994 Jun 18, 2010 Jun 18, 2010 Dec 31, 1985 Dec 31, 1985

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

IOPROMIDE
INJECTABLE; INJECTION

ULTRAVIST (PHARMACY BULK)

+ BAYER HLTHCARE 49.9% + 62.3% + 76.9% ULTRAVIST 150 + BAYER HLTHCARE 31.2% ULTRAVIST 240 + BAYER HLTHCARE 49.9% ULTRAVIST 300 + BAYER HLTHCARE 62.3% ULTRAVIST 300 IN PLASTIC CONTAINER + BAYER HLTHCARE 62.3% ULTRAVIST 370 + BAYER HLTHCARE 76.9%

3 - 234 (of 424)

XX XX XX XX XX XX XX XX

N021425 003 N021425 001 N021425 002 N020220 004 N020220 003 N020220 002 N020220 005 N020220 001

Mar 12, 2004 Sep 20, 2002 Sep 20, 2002 May 10, 1995 May 10, 1995 May 10, 1995 Nov 18, 2008 May 10, 1995

IOTHALAMATE MEGLUMINE
INJECTABLE; INJECTION

CONRAY

XX + MALLINCKRODT CONRAY 30

XX + MALLINCKRODT CONRAY 43

XX + MALLINCKRODT SOLUTION; INTRAVESICAL

CYSTO-CONRAY II

MALLINCKRODT XX

60% 30% 43%

N013295 001

N016983 001

N013295 002

17.2%

N017057 002

IOVERSOL
INJECTABLE; INJECTION

OPTIRAY 240

+ MALLINCKRODT OPTIRAY 300 + MALLINCKRODT + OPTIRAY 320 + MALLINCKRODT OPTIRAY 350 + MALLINCKRODT +

XX XX XX XX XX XX

51% 64% 64% 68% 74% 74%

N019710 002 N019710 004 N020923 004 N019710 001 N019710 005 N020923 003

Dec 30, 1988 Jan 22, 1992 May 13, 1999 Dec 30, 1988 Jan 22, 1992 May 28, 1998

IOXAGLATE MEGLUMINE; IOXAGLATE SODIUM

INJECTABLE; INJECTION

HEXABRIX

XX + GUERBET

39.3%;19.6%

N018905 002

Jul 26, 1985

IOXILAN
INJECTABLE; INJECTION OXILAN-300 GUERBET XX OXILAN-350 GUERBET XX

62% 73%

N020316 001 N020316 002

Dec 21, 1995 Dec 21, 1995

IPRATROPIUM BROMIDE
AEROSOL, METERED; INHALATION

ATROVENT HFA

XX + BOEHRINGER INGELHEIM 0.021MG/INH

N021527 001

Nov 27, 2004

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

IPRATROPIUM BROMIDE
SOLUTION; INHALATION IPRATROPIUM BROMIDE BAUSCH AND LOMB + DEY LANDELA PHARM NEPHRON NOVEX RITEDOSE CORP TEVA PARENTERAL WATSON LABS

3 - 235 (of 424)

AN AN AN AN AN AN AN AN

0.02% 0.02% 0.02% 0.02% 0.02% 0.02% 0.02% 0.02%

A075835 A074755 A077072 A075562 A075441 A075693 A075313 A076291

001 001 001 001 001 001 001 001

Oct Jan Jul Sep Mar Jan Feb May

15, 10, 19, 27, 28, 26, 07, 09,

2001 1997 2005 2001 2001 2001 2000 2005

SPRAY, METERED; NASAL ATROVENT AB + BOEHRINGER INGELHEIM AB + IPRATROPIUM BROMIDE BAUSCH AND LOMB AB AB DEY AB AB NOVEX AB AB ROXANE AB AB

0.021MG/SPRAY 0.042MG/SPRAY 0.021MG/SPRAY 0.042MG/SPRAY 0.021MG/SPRAY 0.042MG/SPRAY 0.021MG/SPRAY 0.042MG/SPRAY 0.021MG/SPRAY 0.042MG/SPRAY

N020393 001 N020394 001 A076025 A076103 A075552 A075553 A076156 A076155 A076664 A076598 001 001 001 001 001 001 001 001

Oct 20, 1995 Oct 20, 1995 Mar Mar Mar Mar Apr Apr Nov Nov 31, 31, 31, 31, 18, 18, 05, 05, 2003 2003 2003 2003 2003 2003 2003 2003

IRBESARTAN
TABLET; ORAL AVAPRO SANOFI AVENTIS US XX XX XX +

75MG 150MG 300MG

N020757 001 N020757 002 N020757 003

Sep 30, 1997 Sep 30, 1997 Sep 30, 1997

IRINOTECAN HYDROCHLORIDE
INJECTABLE; INJECTION CAMPTOSAR 40MG/2ML (20MG/ML) + PFIZER INC 100MG/5ML (20MG/ML) + IRINOTECAN HYDROCHLORIDE ACCORD HLTHCARE 40MG/2ML (20MG/ML) 100MG/5ML (20MG/ML) ACTAVIS TOTOWA 40MG/2ML (20MG/ML) 100MG/5ML (20MG/ML) AKORN 40MG/2ML (20MG/ML) 100MG/5ML (20MG/ML) APP PHARMS 40MG/2ML (20MG/ML) 100MG/5ML (20MG/ML) BEDFORD LABS 40MG/2ML (20MG/ML) 100MG/5ML (20MG/ML) BIONICHE PHARMA 40MG/2ML (20MG/ML) 100MG/5ML (20MG/ML) DR REDDYS LABS LTD 40MG/2ML (20MG/ML) 100MG/5ML (20MG/ML) EBEWE PHARMA 40MG/2ML (20MG/ML) 100MG/5ML (20MG/ML) FRESENIUS KABI ONCOL 40MG/2ML (20MG/ML) 100MG/5ML (20MG/ML) HIKMA FARMACEUTICA 40MG/2ML (20MG/ML) 100MG/5ML (20MG/ML) HOSPIRA 40MG/2ML (20MG/ML) 100MG/5ML (20MG/ML)

AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP

N020571 001 N020571 002 A079068 A079068 A078589 A078589 A090726 A090726 A077776 A077776 A078753 A078753 A090393 A090393 A078953 A078953 A090137 A090137 A078188 A078188 A091032 A091032 A077915 A077915 001 002 001 002 001 002 001 002 001 002 002 003 001 002 001 002 001 002 001 002 001 002

Jun 14, 1996 Jun 14, 1996 Nov Nov Feb Feb Sep Sep Feb Feb Dec Dec May May Apr Apr Nov Nov Feb Feb Dec Dec Feb Feb 21, 21, 27, 27, 16, 16, 27, 27, 24, 24, 13, 13, 15, 15, 12, 12, 27, 27, 20, 20, 27, 27, 2008 2008 2008 2008 2009 2009 2008 2008 2008 2008 2011 2011 2010 2010 2009 2009 2008 2008 2010 2010 2008 2008

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

IRINOTECAN HYDROCHLORIDE
INJECTABLE; INJECTION IRINOTECAN HYDROCHLORIDE + HOSPIRA 500MG/25ML (20MG/ML) JIANGSU HENGRUI MED 40MG/2ML (20MG/ML) 100MG/5ML (20MG/ML) PLIVA LACHEMA 40MG/2ML (20MG/ML) 100MG/5ML (20MG/ML) SUN PHARMA GLOBAL 40MG/2ML (20MG/ML) 100MG/5ML (20MG/ML) TEVA PARENTERAL 40MG/2ML (20MG/ML) 100MG/5ML (20MG/ML) 500MG/25ML (20MG/ML) WATSON LABS 40MG/2ML (20MG/ML) 100MG/5ML (20MG/ML) X-GEN PHARMS 40MG/2ML (20MG/ML) 100MG/5ML (20MG/ML) CAMPTOSAR + PFIZER INC 300MG/15ML (20MG/ML)

3 - 236 (of 424)

AP AP AP AP AP AP AP AP AP AP AP AP AP AP XX

A078796 A090675 A090675 A078122 A078122 A078805 A078805 A077260 A077260 A090101 A077219 A077219 A090016 A090016

001 002 001 001 002 001 002 001 002 001 001 002 001 002

Feb Dec Dec Oct Oct Apr Apr Feb Feb Nov Feb Feb Jan Jan

27, 16, 16, 31, 31, 21, 21, 27, 27, 26, 20, 20, 28, 28,

2008 2011 2011 2008 2008 2008 2008 2008 2008 2008 2008 2008 2009 2009

N020571 003

Aug 05, 2010

IRON DEXTRAN
INJECTABLE; INJECTION DEXFERRUM BP LUITPOLD INFED BP + WATSON LABS (UTAH) PROFERDEX BP NEW RIVER

EQ 50MG IRON/ML EQ 50MG IRON/ML EQ 50MG IRON/ML

N040024 001 N017441 001 N017807 001

Feb 23, 1996

IRON SUCROSE
INJECTABLE; INTRAVENOUS VENOFER LUITPOLD XX XX + XX

EQ 50MG BASE/2.5ML (EQ 20MG BASE/ML) EQ 100MG BASE/5ML (EQ 20MG BASE/ML) EQ 200MG BASE/10ML (EQ 20MG BASE/ML)

N021135 002 N021135 001 N021135 004

Mar 20, 2005 Nov 06, 2000 Feb 09, 2007

ISOCARBOXAZID
TABLET; ORAL

MARPLAN

XX + VALIDUS PHARMS INC

10MG

N011961 001

ISOFLURANE
LIQUID; INHALATION FORANE + BAXTER HLTHCARE CORP ISOFLURANE HALOCARBON PRODS HOSPIRA PIRAMAL CRITICAL RHODIA

AN AN AN AN AN

99.9% 99.9% 99.9% 99.9% 99.9%

N017624 001 A075225 A074097 A074416 A074502 001 001 001 001 Oct Jan Sep Jun 20, 25, 30, 27, 1999 1993 1994 1995

ISONIAZID
INJECTABLE; INJECTION

ISONIAZID

XX + SANDOZ SYRUP; ORAL

ISONIAZID

XX + CAROLINA MEDCL

100MG/ML

A040648 001

Jul 05, 2005

50MG/5ML

A088235 001

Nov 10, 1983

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

ISONIAZID
TABLET; ORAL ISONIAZID BARR AA AA MIKART AA AA AA + SANDOZ AA + WATSON LABS AA WEST WARD AA AA

3 - 237 (of 424)

100MG 300MG 100MG 300MG 100MG 300MG 300MG 100MG 300MG

A080936 A080937 A040090 A040090 N008678 N008678 A080521 A080212 A087425

001 002 001 002 002 003 001 001 001

Jun 26, 1997 Jun 26, 1997

ISONIAZID; PYRAZINAMIDE; RIFAMPIN

TABLET; ORAL
RIFATER
XX + SANOFI AVENTIS US

50MG;300MG;120MG

N050705 001

May 31, 1994

ISONIAZID; RIFAMPIN
CAPSULE; ORAL RIFAMATE AB + SANOFI AVENTIS US RIFAMPIN AND ISONIAZID WESTWARD AB

150MG;300MG 150MG;300MG

A061884 001 A065221 001 Jul 29, 2005

ISOPROTERENOL HYDROCHLORIDE
INJECTABLE; INJECTION ISOPROTERENOL HYDROCHLORIDE INTL MEDICATION AP 0.2MG/ML ISUPREL AP + HOSPIRA 0.2MG/ML

A083724 001 N010515 001

ISOSORBIDE DINITRATE
CAPSULE, EXTENDED RELEASE; ORAL
DILATRATE-SR
40MG XX + SCHWARZ PHARMA TABLET; ORAL ISORDIL VALEANT INTL AB AB AB AB + ISOSORBIDE DINITRATE PAR PHARM AB AB AB AB SANDOZ AB AB AB WATSON LABS AB AB WEST WARD AB AB AB AB ISORDIL XX + VALEANT INTL

N019790 001

Sep 02, 1988

5MG 10MG 20MG 30MG 5MG 10MG 20MG 30MG 5MG 10MG 20MG 5MG 10MG 5MG 10MG 20MG 30MG 40MG

N012093 N012093 N012093 N012093 A086923 A086925 A087537 A087946 A086221 A086223 A089367 A086034 A086032 A086067 A086066 A088088 A040591

007 002 006 005 001 001 001 001 001 001 001 001 001 001 001 001 001

Jul Jul Jul Jul Mar Mar Oct Jan Jan Jan Apr Jan Jan Oct Oct Nov Jan

29, 29, 29, 29, 12, 12, 02, 12, 07, 07, 07, 06, 07, 29, 29, 02, 10,

1988 1988 1988 1988 1987 1987 1987 1988 1988 1988 1988 1988 1988 1987 1987 1987 2007

N012093 001

Jul 29, 1988

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

ISOSORBIDE DINITRATE
TABLET; SUBLINGUAL ISOSORBIDE DINITRATE WATSON LABS AB AB + WEST WARD AB AB

3 - 238 (of 424)

2.5MG 5MG 2.5MG 5MG

A086033 A086031 A086054 A086055

001 001 001 001

Feb Sep Oct Nov

26, 29, 29, 02,

1988 1987 1987 1987

TABLET, EXTENDED RELEASE; ORAL ISOSORBIDE DINITRATE AB + CARACO 40MG COREPHARMA AB 40MG

A040009 001 A040723 001

Dec 30, 1998 Mar 17, 2008

ISOSORBIDE MONONITRATE
TABLET; ORAL ISOSORBIDE MONONITRATE ACTAVIS ELIZABETH AB AB TEVA AB WEST WARD AB MONOKET UCB INC AB AB +

10MG 20MG 20MG 20MG 10MG 20MG

A075037 A075037 A075147 A075361

002 001 001 001

Oct Oct Nov Oct

30, 30, 27, 05,

1998 1998 1998 2000

N020215 002 N020215 001

Jun 30, 1993 Jun 30, 1993

TABLET, EXTENDED RELEASE; ORAL ISOSORBIDE MONONITRATE ACTAVIS ELIZABETH AB 30MG AB 60MG BRIGHTSTONE AB 60MG DEXCEL LTD AB 60MG ELAN PHARM AB 60MG KREMERS URBAN PHARMS 30MG AB AB 60MG AB + 120MG NESHER PHARMS AB 30MG AB 60MG AB 120MG TORRENT PHARMS AB 30MG AB 60MG AB 120MG VINTAGE PHARMS AB 30MG AB 60MG AB 120MG WEST WARD AB 30MG AB 60MG

A075306 A075306 A075166 A075522 A075041 A075155 A075155 A075155 A075395 A075395 A075395 A200270 A200495 A200495 A090598 A090598 A090598 A076813 A076813

001 002 001 001 001 002 001 003 001 002 003 001 001 002 001 002 003 002 001

Dec Dec Oct Apr Sep Jan Oct Aug Mar Mar Mar Jun Jun Jun Aug Aug Aug Mar Jan

31, 31, 07, 17, 22, 13, 30, 04, 16, 16, 16, 03, 03, 03, 11, 11, 11, 30, 07,

1998 1998 1999 2000 1998 2000 1998 2000 2000 2000 2000 2011 2011 2011 2010 2010 2010 2006 2005

ISOSULFAN BLUE
INJECTABLE; INJECTION ISOSULFAN BLUE SYNERX AP LYMPHAZURIN AP + COVIDIEN

1% 1%

A090874 001 N018310 001

Jul 20, 2010

ISOTRETINOIN
CAPSULE; ORAL AMNESTEEM MYLAN + + CLARAVIS BARR

AB AB AB AB

10MG 20MG 40MG 10MG

A075945 001 A075945 002 A075945 003 A076356 001

Nov 08, 2002 Nov 08, 2002 Nov 08, 2002 Apr 11, 2003

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

ISOTRETINOIN
CAPSULE; ORAL CLARAVIS BARR AB AB AB SOTRET RANBAXY AB AB AB AB

3 - 239 (of 424)

20MG 30MG 40MG 10MG 20MG 30MG 40MG

A076135 002 A076135 003 A076135 001 A076041 A076041 A076503 A076041 001 002 001 003

Apr 11, 2003 May 11, 2006 Apr 11, 2003 Dec Dec Jun Dec 24, 24, 20, 24, 2002 2002 2003 2002

ISRADIPINE
CAPSULE; ORAL ISRADIPINE MIKAH PHARMA AB AB WATSON LABS AB AB +

2.5MG 5MG 2.5MG 5MG

A077169 A077169 A077317 A077317

001 002 001 002

Apr Apr Jan Jan

24, 24, 05, 05,

2006 2006 2006 2006

TABLET, EXTENDED RELEASE; ORAL DYNACIRC CR GLAXOSMITHKLINE LLC 5MG XX 10MG XX +

N020336 001 N020336 002

Jun 01, 1994 Jun 01, 1994

ITRACONAZOLE
CAPSULE; ORAL ITRACONAZOLE SANDOZ AB SPORANOX AB + JANSSEN PHARMS
SOLUTION; ORAL

SPORANOX
XX + JANSSEN PHARMS
TABLET; ORAL

ONMEL
XX + STIEFEL LABS INC

100MG 100MG

A076104 001 N020083 001

May 28, 2004 Sep 11, 1992

10MG/ML

N020657 001

Feb 21, 1997

200MG

N022484 001

Apr 29, 2010

IVERMECTIN

TABLET; ORAL

STROMECTOL
XX + MERCK

3MG

N050742 002

Oct 08, 1998

IXABEPILONE
INJECTABLE; IV (INFUSION)
IXEMPRA KIT
XX + BRISTOL MYERS SQUIBB 15MG/VIAL XX + 45MG/VIAL

N022065 001 N022065 002

Oct 16, 2007 Oct 16, 2007

KANAMYCIN SULFATE
INJECTABLE; INJECTION KANAMYCIN SULFATE APP PHARMS XX XX +

EQ 500MG BASE/2ML EQ 1GM BASE/3ML

A065111 001 A065111 002

Dec 17, 2002 Dec 17, 2002

KETAMINE HYDROCHLORIDE
INJECTABLE; INJECTION KETALAR AP + JHP PHARMS AP +

EQ 10MG BASE/ML EQ 50MG BASE/ML

N016812 001 N016812 002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

KETAMINE HYDROCHLORIDE
INJECTABLE; INJECTION KETALAR AP + JHP PHARMS KETAMINE HYDROCHLORIDE BEDFORD AP AP BIONICHE PHARMA AP AP AP HOSPIRA AP AP

3 - 240 (of 424)

EQ 100MG BASE/ML EQ EQ EQ EQ EQ EQ EQ 50MG BASE/ML 100MG BASE/ML 10MG BASE/ML 50MG BASE/ML 100MG BASE/ML 50MG BASE/ML 100MG BASE/ML

N016812 003 A074524 A074524 A076092 A076092 A076092 A074549 A074549 001 002 001 002 003 001 002 Mar Mar Sep Dec Oct Jun Jun 22, 22, 30, 28, 25, 27, 27, 1996 1996 2008 2001 2002 1996 1996

KETOCONAZOLE
AEROSOL, FOAM; TOPICAL EXTINA AT + STIEFEL LABS INC KETOCONAZOLE PERRIGO ISRAEL AT CREAM; TOPICAL KETOCONAZOLE ALTANA AB AB + TEVA KETOZOLE TARO AB GEL; TOPICAL
XOLEGEL
XX + AQUA PHARMS SHAMPOO; TOPICAL KETOCONAZOLE PERRIGO NEW YORK AB TOLMAR AB NIZORAL AB + JANSSEN PHARMS TABLET; ORAL KETOCONAZOLE APOTEX MUTUAL PHARMA MYLAN PLIVA TARO TEVA NIZORAL + ORTHO MCNEIL JANSSEN

2% 2%

N021738 001 A091550 001

Jun 12, 2007 Aug 25, 2011

2% 2% 2%

A076294 001 A075581 001 A075638 001

Apr 28, 2004 Apr 25, 2000 Dec 18, 2002

2%

N021946 001

Jul 28, 2006

2% 2% 2%

A076419 001 A076942 001 N019927 001

Jan 07, 2004 Apr 11, 2005 Aug 31, 1990

AB AB AB AB AB AB AB

200MG 200MG 200MG 200MG 200MG 200MG 200MG

A075912 A075314 A075597 A075362 A075319 A075273

001 001 001 001 001 001

Jan Jun Dec Jun Jun Jun

10, 15, 23, 15, 15, 15,

2002 1999 1999 1999 1999 1999

N018533 001

KETOPROFEN
CAPSULE; ORAL KETOPROFEN HERITAGE PHARMS INC AB AB MYLAN AB AB TEVA AB AB + KETOPROFEN HERITAGE PHARMS INC XX

50MG 75MG 50MG 75MG 50MG 75MG 25MG

A074014 A074014 A074035 A074035 A073516 A073517

002 003 002 003 001 001

Jan Jan Dec Dec Dec Dec

29, 29, 31, 31, 22, 22,

1993 1993 1996 1996 1992 1992

A074014 001

Jan 29, 1993

CAPSULE, EXTENDED RELEASE; ORAL KETOPROFEN ELAN PHARM AB 200MG

A074879 001

Dec 10, 1997

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

KETOPROFEN
CAPSULE, EXTENDED RELEASE; ORAL KETOPROFEN MYLAN AB 100MG AB 150MG AB + 200MG WATSON LABS FLORIDA AB 100MG AB 150MG AB 200MG

3 - 241 (of 424)

A075679 A075679 A075679 A075270 A075270 A075270

003 002 001 002 003 001

Feb Feb Feb Mar Mar Mar

20, 20, 20, 24, 24, 24,

2002 2002 2002 1999 1999 1999

KETOROLAC TROMETHAMINE
INJECTABLE; INJECTION KETOROLAC TROMETHAMINE APP PHARMS AP AP BAXTER HLTHCARE AP AP BAXTER HLTHCARE CORP AP AP AP + BEDFORD AP + AP + CLARIS LIFESCIENCES AP AP HOSPIRA AP AP AP AP LUITPOLD AP AP PFIZER AP AP SANDOZ AP AP SUN PHARMA GLOBAL AP AP WOCKHARDT AP AP AP

15MG/ML 30MG/ML 15MG/ML 30MG/ML 15MG/ML 30MG/ML 15MG/ML 30MG/ML 30MG/ML 15MG/ML 30MG/ML 15MG/ML 15MG/ML 30MG/ML 30MG/ML 15MG/ML 30MG/ML 15MG/ML 30MG/ML 15MG/ML 30MG/ML 15MG/ML 30MG/ML 15MG/ML 30MG/ML 30MG/ML

A075784 A075784 A075772 A075772 A075299 A075299 A075222 A075222 A075228 A075631 A075631 A074802 A074993 A074802 A074993 A078145 A078145 A078299 A078299 A076271 A076271 A078737 A078737 A077942 A077942 A077943

001 002 001 002 001 002 001 002 001 002 001 001 001 002 002 001 002 001 002 001 002 001 002 001 002 001

Jan Jan Jul Jul Nov Nov Apr Apr Apr Jun Jun Jun Jan Jun Jan Jan Jan Jul Jul Oct Oct Oct Oct Mar Mar Mar

11, 11, 21, 21, 03, 03, 26, 26, 26, 29, 29, 05, 27, 05, 27, 14, 14, 16, 16, 06, 06, 06, 06, 27, 27, 27,

2002 2002 2004 2004 1999 1999 1999 1999 1999 2001 2001 1997 1999 1997 1999 2008 2008 2007 2007 2004 2004 2008 2008 2007 2007 2007

AT AT AT AT AT AT AT AT AT XX XX

SOLUTION/DROPS; OPHTHALMIC ACULAR + ALLERGAN 0.5% ACULAR LS + ALLERGAN 0.4% KETOROLAC TROMETHAMINE AKORN 0.4% 0.5% ALCON PHARMS LTD 0.4% 0.5% APOTEX INC 0.4% 0.5% SUN PHARMA GLOBAL 0.5% ACULAR PRESERVATIVE FREE + ALLERGAN 0.5% ACUVAIL + ALLERGAN 0.45%

N019700 001 N021528 001 A078399 A078434 A078721 A076583 A077308 A076109 A090017 001 001 001 001 001 001 001

Nov 09, 1992 May 30, 2003 Nov Nov Nov Nov Nov Nov Nov 05, 05, 05, 05, 05, 05, 05, 2009 2009 2009 2009 2009 2009 2009

N020811 001 N022427 001

Nov 03, 1997 Jul 22, 2009

SPRAY, METERED; NASAL

SPRIX
XX + LUITPOLD

15.75MG/SPRAY

N022382 001

May 14, 2010

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

KETOROLAC TROMETHAMINE
TABLET; ORAL KETOROLAC TROMETHAMINE AB + MYLAN PLIVA AB TEVA AB

3 - 242 (of 424)

10MG 10MG 10MG

A074761 001 A075284 001 A074754 001

May 16, 1997 Jun 23, 1999 May 16, 1997

LABETALOL HYDROCHLORIDE
INJECTABLE; INJECTION LABETALOL HYDROCHLORIDE BEDFORD CLARIS LIFESCIENCES + HOSPIRA + TAYLOR LABETALOL HYDROCLORIDE SAGENT STRIDES

AP AP AP AP AP AP AP

5MG/ML 5MG/ML 5MG/ML 5MG/ML 5MG/ML 5MG/ML 5MG/ML

A075303 A076051 A075239 A075240 A075431 A075524

001 001 001 001 001 001

May Jul Nov Nov Nov Nov

28, 05, 29, 29, 29, 29,

1999 2002 1999 1999 1999 1999

A079134 001

Feb 03, 2010

TABLET; ORAL LABETALOL HYDROCHLORIDE IVAX SUB TEVA PHARMS 100MG AB AB 200MG AB 300MG SANDOZ AB 100MG AB 200MG AB 300MG WATSON LABS AB 100MG AB 200MG AB 300MG TRANDATE PROMETHEUS LABS AB 100MG AB + 200MG

A074787 A074787 A074787 A075113 A075113 A075113 A075133 A075133 A075133

001 002 003 001 002 003 001 002 003

Aug Aug Aug Aug Aug Aug Aug Aug Aug

03, 03, 03, 04, 04, 04, 03, 03, 03,

1998 1998 1998 1998 1998 1998 1998 1998 1998

N018716 001 N018716 002

May 24, 1985 Aug 01, 1984

LACOSAMIDE
SOLUTION; INTRAVENOUS

VIMPAT

XX + UCB INC SOLUTION; ORAL

VIMPAT

XX + UCB INC TABLET; ORAL VIMPAT UCB INC XX XX XX XX +

200MG/20ML (10MG/ML)

N022254 001

Oct 28, 2008

10MG/ML

N022255 001

Apr 20, 2010

50MG 100MG 150MG 200MG

N022253 N022253 N022253 N022253

001 002 003 004

Oct Oct Oct Oct

28, 28, 28, 28,

2008 2008 2008 2008

LACTULOSE
FOR SOLUTION; ORAL

LACTULOSE

XX + INALCO XX + SOLUTION; ORAL CONSTILAC ALRA AA CONSTULOSE AA + ACTAVIS MID ATLANTIC LACTULOSE ANI PHARMS AA

10GM/PACKET 20GM/PACKET

A074712 001 A074712 002

Dec 10, 1997 Dec 10, 1997

10GM/15ML 10GM/15ML 10GM/15ML

A071054 001 A070288 001 A078430 001

Jul 26, 1988 Aug 15, 1988 Nov 28, 2007

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

LACTULOSE
SOLUTION; ORAL LACTULOSE HI TECH PHARMA MORTON GROVE NOVEX PHARM ASSOC ROXANE VINTAGE PHARMS VISTAPHARM SOLUTION; ORAL, RECTAL CHOLAC ALRA ENULOSE + ACTAVIS MID ATLANTIC GENERLAC MORTON GROVE PHARMS LACTULOSE ANI PHARMS HI TECH PHARMA NOVEX

3 - 243 (of 424)

AA AA AA AA AA AA AA

10GM/15ML 10GM/15ML 10GM/15ML 10GM/15ML 10GM/15ML 10GM/15ML 10GM/15ML

A074076 A074602 A075911 A074623 A073591 A075993 A074138

001 001 001 001 001 001 001

Jul Nov Feb Jul May Jul Sep

03, 14, 21, 30, 29, 26, 30,

1995 1996 2002 1996 1992 2001 1992

AA AA AA AA AA AA

10GM/15ML 10GM/15ML 10GM/15ML 10GM/15ML 10GM/15ML 10GM/15ML

A071331 001 A071548 001 A074603 001 A090426 001 A074077 001 A076645 001

Jul 26, 1988 Aug 15, 1988 Oct 31, 1996 Nov 21, 2008 Jul 03, 1995 Jul 28, 2003

LAMIVUDINE
SOLUTION; ORAL

EPIVIR

XX + VIIV HLTHCARE EPIVIR-HBV XX + GLAXOSMITHKLINE TABLET; ORAL EPIVIR VIIV HLTHCARE AB AB + LAMIVUDINE APOTEX AB AB AUROBINDO PHARMA LTD AB AB EPIVIR-HBV XX + GLAXOSMITHKLINE

10MG/ML 5MG/ML

N020596 001 N021004 001

Nov 17, 1995 Dec 08, 1998

150MG 300MG 150MG 300MG 150MG 300MG 100MG

N020564 001 N020564 003 A091606 A091606 A202032 A202032 001 002 001 002

Nov 17, 1995 Jun 24, 2002 Dec Dec Nov Nov 02, 02, 17, 17, 2011 2011 2011 2011

N021003 001

Dec 08, 1998

LAMIVUDINE; ZIDOVUDINE
TABLET; ORAL COMBIVIR AB + VIIV HLTHCARE 150MG;300MG LAMIVUDINE AND ZIDOVUDINE TEVA PHARMS AB 150MG;300MG

N020857 001 A079081 001

Sep 26, 1997 May 25, 2011

LAMOTRIGINE
TABLET; ORAL LAMICTAL AB + GLAXOSMITHKLINE AB AB AB LAMOTRIGINE ACTAVIS TOTOWA AB AB AB AB ALEMBIC PHARMS LTD AB

25MG 100MG 150MG 200MG 25MG 100MG 150MG 200MG 25MG

N020241 N020241 N020241 N020241 A078669 A078669 A078669 A078669 A090607

005 001 002 003 001 002 003 004 001

Dec Dec Dec Dec Apr Apr Apr Apr Jan

27, 27, 27, 27, 08, 08, 08, 08, 13,

1994 1994 1994 1994 2011 2011 2011 2011 2011

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

LAMOTRIGINE
TABLET; ORAL LAMOTRIGINE ALEMBIC PHARMS LTD AB AB AB APOTEX INC AB AB AB AB AUROBINDO PHARMA AB AB AB AB CADISTA PHARMS AB AB AB AB DR REDDYS LABS LTD AB AB AB AB HIKMA PHARMS AB AB AB AB LUPIN LTD AB AB AB AB MYLAN AB AB AB AB SANDOZ AB AB AB AB TARO PHARM INDS AB AB AB AB TEVA AB AB AB AB TORRENT PHARMS AB AB AB AB UNICHEM LABS LTD AB AB AB AB UPSHER SMITH AB AB AB AB WATSON LABS AB AB

3 - 244 (of 424)

100MG 150MG 200MG 25MG 100MG 150MG 200MG 25MG 100MG 150MG 200MG 25MG 100MG 150MG 200MG 25MG 100MG 150MG 200MG 25MG 100MG 150MG 200MG 25MG 100MG 150MG 200MG 25MG 100MG 150MG 200MG 25MG 100MG 150MG 200MG 25MG 100MG 150MG 200MG 25MG 100MG 150MG 200MG 25MG 100MG 150MG 200MG 25MG 100MG 150MG 200MG 25MG 100MG 150MG 200MG 25MG 100MG

A090607 A090607 A090607 A078625 A078625 A078625 A078625 A078956 A078956 A078956 A078956 A079132 A079132 A079132 A079132 A076708 A076708 A076708 A076708 A078134 A078134 A078134 A078134 A078691 A078691 A078691 A078691 A077420 A077420 A077420 A077420 A078645 A078645 A078645 A078645 A078525 A078525 A078525 A078525 A076388 A076388 A076388 A076388 A078947 A078947 A078947 A078947 A090170 A090170 A090170 A090170 A078310 A078310 A078310 A078310 A077783 A077783

002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002

Jan Jan Jan Jan Jan Jan Jan Jan Jan Jan Jan Jan Jan Jan Jan Jan Jan Jan Jan Apr Apr Apr Apr Jun Jun Jun Jun Jan Jan Jan Jan Jan Jan Jan Jan Jan Jan Jan Jan Aug Aug Aug Aug Jan Jan Jan Jan Oct Oct Oct Oct Feb Feb Feb Feb Nov Nov

13, 13, 13, 27, 27, 27, 27, 27, 27, 27, 27, 27, 27, 27, 27, 27, 27, 27, 27, 19, 19, 19, 19, 01, 01, 01, 01, 27, 27, 27, 27, 27, 27, 27, 27, 27, 27, 27, 27, 30, 30, 30, 30, 27, 27, 27, 27, 06, 06, 06, 06, 04, 04, 04, 04, 01, 01,

2011 2011 2011 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2011 2011 2011 2011 2010 2010 2010 2010 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2006 2006 2006 2006 2009 2009 2009 2009 2011 2011 2011 2011 2009 2009 2009 2009 2010 2010

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

LAMOTRIGINE
TABLET; ORAL LAMOTRIGINE WATSON LABS AB AB ZYDUS PHARMS USA AB AB AB AB LAMOTRIGINE ZYDUS PHARMS USA XX XX TABLET, CHEWABLE; ORAL LAMICTAL CD GLAXOSMITHKLINE AB AB AB + LAMOTRIGINE AUROBINDO PHARMA AB AB DR REDDYS LABS LTD AB AB GLENMARK GENERICS AB AB JUBILANT LIFE AB AB MYLAN AB AB TARO AB AB TEVA AB AB WATSON LABS AB AB AB ZYDUS PHARMS USA INC AB AB

3 - 245 (of 424)

150MG 200MG 25MG 100MG 150MG 200MG 50MG 250MG

A077783 A077783 A077633 A077633 A077633 A077633

003 004 001 003 004 005

Nov Nov Jan Jan Jan Jan

01, 01, 27, 27, 27, 27,

2010 2010 2009 2009 2009 2009

A077633 002 A077633 006

Jan 27, 2009 Jan 27, 2009

2MG 5MG 25MG 5MG 25MG 5MG 25MG 5MG 25MG 5MG 25MG 5MG 25MG 5MG 25MG 5MG 25MG 2MG 5MG 25MG 5MG 25MG

N020764 004 N020764 001 N020764 002 A090401 A090401 A076701 A076701 A079099 A079099 A200220 A200220 A076630 A076630 A079204 A079204 A076420 A076420 A076928 A076928 A076928 A078009 A078009 002 003 001 002 001 002 001 002 001 002 001 002 001 002 001 002 003 002 003

Sep 08, 2000 Aug 24, 1998 Aug 24, 1998 Nov Nov Jan Jan Feb Feb Feb Feb Jan Jan Feb Feb Jun Jun Jan Jan Jan Jan Jan 04, 04, 22, 22, 19, 19, 28, 28, 22, 22, 04, 04, 21, 21, 22, 22, 22, 22, 22, 2009 2009 2009 2009 2009 2009 2011 2011 2009 2009 2009 2009 2006 2006 2009 2009 2009 2009 2009

TABLET, EXTENDED RELEASE; ORAL LAMICTAL XR SMITHKLINE BEECHAM 25MG XX 50MG XX + 100MG XX 200MG XX 250MG XX 300MG XX TABLET, ORALLY DISINTEGRATING; ORAL LAMICTAL ODT SMITHKLINE BEECHAM 25MG XX 50MG XX + 100MG XX 200MG XX

N022115 N022115 N022115 N022115 N022115 N022115

001 002 003 004 006 005

May May May May Jun Apr

29, 29, 29, 29, 21, 14,

2009 2009 2009 2009 2011 2010

N022251 N022251 N022251 N022251

001 002 003 004

May May May May

08, 08, 08, 08,

2009 2009 2009 2009

LANREOTIDE ACETATE

INJECTABLE; SUBCUTANEOUS

SOMATULINE DEPOT
XX + IPSEN PHARMS XX + XX +

EQ 60MG BASE EQ 90MG BASE EQ 120MG BASE

N022074 001 N022074 002 N022074 003

Aug 30, 2007 Aug 30, 2007 Aug 30, 2007

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

LANSOPRAZOLE
CAPSULE, DELAYED REL PELLETS; ORAL LANSOPRAZOLE DR REDDYS LABS LTD 15MG 30MG MATRIX LABS LTD 15MG 30MG SANDOZ 15MG 30MG TEVA PHARMS 15MG 30MG PREVACID TAKEDA PHARMS NA 15MG + 30MG

3 - 246 (of 424)

AB AB AB AB AB AB AB AB AB AB

A091269 A091269 A090763 A090763 A090331 A090331 A077255 A077255

001 002 001 002 001 002 001 002

Oct Oct Nov Nov Apr Apr Nov Nov

15, 15, 10, 10, 23, 23, 10, 10,

2010 2010 2009 2009 2010 2010 2009 2009

N020406 001 N020406 002

May 10, 1995 May 10, 1995

TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING; ORAL LANSOPRAZOLE TEVA PHARMS 15MG AB 30MG AB PREVACID TAKEDA PHARMS NA AB 15MG AB + 30MG

A078730 001 A078730 002 N021428 001 N021428 002

Oct 15, 2010 Oct 15, 2010 Aug 30, 2002 Aug 30, 2002

LANTHANUM CARBONATE
TABLET, CHEWABLE; ORAL FOSRENOL SHIRE XX XX XX +

EQ 500MG BASE EQ 750MG BASE EQ 1GM BASE

N021468 002 N021468 003 N021468 004

Oct 26, 2004 Nov 23, 2005 Nov 23, 2005

LAPATINIB DITOSYLATE
TABLET; ORAL
TYKERB
XX + SMITHKLINE BEECHAM

EQ 250MG BASE

N022059 001

Mar 13, 2007

LATANOPROST
SOLUTION/DROPS; OPHTHALMIC LATANOPROST ALCON RES 0.005% APOTEX 0.005% BAUSCH AND LOMB 0.005% LUITPOLD 0.005% MYLAN 0.005% PADDOCK LLC 0.005% XALATAN + PHARMACIA AND UPJOHN 0.005%

AT AT AT AT AT AT AT

A091449 A077697 A201006 A200925 A201786 A090887

001 001 001 001 001 001

Mar Mar Mar Mar Mar Jul

22, 22, 22, 22, 22, 19,

2011 2011 2011 2011 2011 2011

N020597 001

Jun 05, 1996

LEFLUNOMIDE
TABLET; ORAL ARAVA SANOFI AVENTIS US AB AB + LEFLUNOMIDE ALEMBIC PHARMS LTD AB AB APOTEX INC AB AB BARR AB AB HERITAGE PHARMS INC AB

10MG 20MG 10MG 20MG 10MG 20MG 10MG 20MG 10MG

N020905 001 N020905 002 A091369 A091369 A077090 A077090 A077083 A077083 A077086 001 002 001 002 001 002 001

Sep 10, 1998 Sep 10, 1998 Nov Nov Sep Sep Sep Sep Sep 21, 21, 13, 13, 13, 13, 13, 2011 2011 2005 2005 2005 2005 2005

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

LEFLUNOMIDE
TABLET; ORAL LEFLUNOMIDE HERITAGE PHARMS INC AB SANDOZ AB AB TEVA PHARMS AB AB ARAVA XX + SANOFI AVENTIS US

3 - 247 (of 424)

20MG 10MG 20MG 10MG 20MG 100MG

A077086 A077087 A077087 A077084 A077084

002 001 002 001 002

Sep Sep Sep Sep Sep

13, 13, 13, 13, 13,

2005 2005 2005 2005 2005

N020905 003

Sep 10, 1998

LENALIDOMIDE
CAPSULE; ORAL REVLIMID CELGENE XX XX XX XX + XX +

2.5MG 5MG 10MG 15MG 25MG

N021880 N021880 N021880 N021880 N021880

005 001 002 003 004

Dec Dec Dec Jun Jun

21, 27, 27, 29, 29,

2011 2005 2005 2006 2006

LEPIRUDIN RECOMBINANT
INJECTABLE; INJECTION

REFLUDAN

XX + BAYER HLTHCARE

50MG/VIAL

N020807 001

Mar 06, 1998

LETROZOLE
TABLET; ORAL FEMARA + NOVARTIS PHARMS LETROZOLE ACCORD HLTHCARE ACTAVIS TOTOWA DR REDDYS LABS LTD ENDO PHARMS FRESENIUS KABI ONCOL IMPAX LABS INDICUS PHARMA KUDCO IRELAND MYLAN NATCO PHARMA LTD ROXANE SUN PHARM INDS LTD TEVA PHARMS

AB AB AB AB AB AB AB AB AB AB AB AB AB AB

2.5MG 2.5MG 2.5MG 2.5MG 2.5MG 2.5MG 2.5MG 2.5MG 2.5MG 2.5MG 2.5MG 2.5MG 2.5MG 2.5MG

N020726 001 A090934 A090292 A091191 A090789 A090491 A091638 A201804 A091098 A078190 A200161 A090838 A091466 A090289 001 001 001 001 001 001 001 001 001 001 001 001 001

Jul 25, 1997 Jun Jul Jun Jun Jun Jun Jun Jun Dec Jun Jun Jun Jun 03, 13, 03, 03, 03, 03, 03, 03, 24, 03, 03, 03, 03, 2011 2011 2011 2011 2011 2011 2011 2011 2008 2011 2011 2011 2011

LEUCOVORIN CALCIUM
INJECTABLE; INJECTION LEUCOVORIN CALCIUM AP + BEDFORD EQ 50MG BASE/VIAL AP + EQ 100MG BASE/VIAL TEVA PARENTERAL AP EQ 50MG BASE/VIAL AP EQ 100MG BASE/VIAL AP EQ 350MG BASE/VIAL LEUCOVORIN CALCIUM PRESERVATIVE FREE APP PHARMS AP EQ 200MG BASE/VIAL AP + BEDFORD EQ 200MG BASE/VIAL AP + EQ 350MG BASE/VIAL LUITPOLD AP EQ 50MG BASE/VIAL LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 500MG BASE/VIAL XX + APP PHARMS EQ 10MG BASE/ML XX + BEDFORD

A089384 A089717 A081278 A081277 A040174 A040258 A040056 A040335 A040338

001 001 001 001 001 001 001 001 001

Sep Mar Sep Sep Jun Feb May Apr Jan

14, 28, 28, 28, 12, 26, 23, 20, 31,

1987 1988 1993 1993 1997 1999 1995 2000 2001

A040286 001 A040347 001

Feb 26, 1999 Apr 25, 2000

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

LEUCOVORIN CALCIUM
TABLET; ORAL LEUCOVORIN CALCIUM BARR AB AB ROXANE AB AB AB + LEUCOVORIN CALCIUM ROXANE XX

3 - 248 (of 424)

EQ EQ EQ EQ EQ

5MG BASE 25MG BASE 5MG BASE 15MG BASE 25MG BASE

A071198 A071199 A072733 A072735 A072736

001 001 001 001 001

Sep Sep Feb Feb Feb

24, 24, 22, 22, 22,

1987 1987 1993 1993 1993

EQ 10MG BASE

A072734 001

Feb 22, 1993

LEUPROLIDE ACETATE
INJECTABLE; INJECTION LEUPROLIDE ACETATE + SANDOZ SUN PHARMA GLOBAL TEVA PARENTERAL LUPRON DEPOT + ABBOTT ENDOCRINE + + ABBOTT LABS + + LUPRON DEPOT-PED + ABBOTT ENDOCRINE + + + + INJECTABLE; SUBCUTANEOUS

ELIGARD

+ TOLMAR THERAP + + +

AP AP AP XX XX XX XX XX XX XX XX XX XX XX

1MG/0.2ML 1MG/0.2ML 1MG/0.2ML 22.5MG/VIAL 30MG/VIAL 45MG/VIAL 3.75MG/VIAL 7.5MG/VIAL 11.25MG/VIAL 7.5MG/VIAL 11.25MG/VIAL 11.25MG/VIAL 15MG/VIAL 30MG/VIAL

A074728 001 A078885 001 A075471 001 N020517 N020517 N020517 N020011 N019732 N020708 N020263 N020263 N020263 N020263 N020263 001 002 003 001 001 001 002 005 007 006 008

Aug 04, 1998 Mar 09, 2009 Oct 25, 2000 Dec May Jun Oct Jan Mar Apr Jan Aug Jan Aug 22, 30, 17, 22, 26, 07, 16, 21, 15, 21, 15, 1995 1997 2011 1990 1989 1997 1993 1994 2011 1994 2011

XX XX XX XX

7.5MG/VIAL 22.5MG/VIAL 30MG/VIAL 45MG/VIAL

N021343 N021379 N021488 N021731

001 001 001 001

Jan Jul Feb Dec

23, 24, 13, 14,

2002 2002 2003 2004

LEVALBUTEROL HYDROCHLORIDE
SOLUTION; INHALATION LEVALBUTEROL HYDROCHLORIDE DEY EQ WATSON LABS INC EQ EQ EQ XOPENEX + SUNOVION EQ + EQ + EQ + EQ

AN AN AN AN AN AN AN AN

0.25% BASE 0.0103% BASE 0.021% BASE 0.042% BASE 0.0103% BASE 0.021% BASE 0.042% BASE 0.25% BASE

A078309 A077756 A077756 A077756 N020837 N020837 N020837 N020837

001 003 001 002 003 001 002 004

Mar Apr Apr Apr Jan Mar Mar Jul

20, 09, 09, 09, 30, 25, 25, 18,

2009 2008 2008 2008 2002 1999 1999 2003

LEVALBUTEROL TARTRATE
AEROSOL, METERED; INHALATION

XOPENEX HFA

EQ 0.045MG BASE/INH XX + SUNOVION

N021730 001

Mar 11, 2005

LEVETIRACETAM
INJECTABLE; IV (INFUSION) KEPPRA AP + UCB INC 500MG/5ML (100MG/ML)

N021872 001

Jul 31, 2006

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

LEVETIRACETAM
INJECTABLE; IV (INFUSION) LEVETIRACETAM HIKMA FARMACEUTICA INNOPHARMA LLC NEXUS PHARMS SUN PHARM INDS LTD LEVETIRACETAM IN SODIUM + HQ SPECIALITY PHARMA + + SOLUTION; ORAL KEPPRA + UCB INC LEVETIRACETAM ACTAVIS MID ATLANTIC AMNEAL PHARMS APOTEX AUROBINDO PHARM CYPRESS PHARM LUPIN LTD ROXANE SILARX TARO TOLMAR TRIS PHARMA INC WOCKHARDT

3 - 249 (of 424)

AP AP AP AP XX XX XX

500MG/5ML(100MG/ML) 500MG/5ML (100MG/ML) 500MG/5ML (100MG/ML) 500MG/5ML (100MG/ML) CHLORIDE 500MG/100ML (5MG/ML) 1000MG/100ML (10MG/ML) 1500MG/100ML (15MG/ML)

A090981 A091485 A090813 A090754

001 001 001 001

Oct Aug May Jun

13, 05, 26, 16,

2011 2011 2010 2010

N202543 001 N202543 002 N202543 003

Nov 09, 2011 Nov 09, 2011 Nov 09, 2011

AA AA AA AA AA AA AA AA AA AA AA AA AA

100MG/ML 100MG/ML 100MG/ML 100MG/ML 100MG/ML 100MG/ML 100MG/ML 100MG/ML 100MG/ML 100MG/ML 100MG/ML 100MG/ML 100MG/ML

N021505 001 A078976 A090992 A090187 A079063 A079120 A090893 A078582 A090263 A078774 A079107 A090461 A090028 001 001 001 001 001 001 001 001 001 001 001 001

Jul 15, 2003 Jan Oct Aug Jan Jan Oct Jan Apr Feb Jan Sep Mar 15, 27, 05, 15, 16, 17, 15, 03, 10, 15, 30, 03, 2009 2009 2011 2009 2009 2011 2009 2009 2009 2009 2010 2010

TABLET; ORAL KEPPRA UCB INC AB AB AB AB + LEVETIRACETAM ACCORD HLTHCARE AB AB AB AB AJANTA PHARMA AB AB AB AB APOTEX INC AB AB AB AB AUROBINDO PHARMA AB AB AB AB BIOKEY AB BOCA PHARMA AB AB AB BRECKENRIDGE PHARM AB AB AB AB COBALT LABS INC AB AB

250MG 500MG 750MG 1GM 250MG 500MG 750MG 1GM 250MG 500MG 750MG 1GM 250MG 500MG 750MG 1GM 250MG 500MG 750MG 1GM 500MG 250MG 500MG 750MG 250MG 500MG 750MG 1GM 250MG 500MG

N021035 N021035 N021035 N021035 A090843 A090843 A090843 A090843 A201293 A201293 A201293 A201293 A078869 A078869 A078869 A078869 A078993 A078993 A078993 A078993 A090906 A077319 A077319 A077319 A090511 A090511 A090511 A090511 A077384 A077384

001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 001 002 003 001 002 003 004 001 002

Nov Nov Nov Jan Feb Feb Feb Feb Jun Jun Jun Jun Mar Mar Mar Mar Jan Jan Jan Jan Nov Mar Mar Mar Aug Aug Aug Aug Jan Jan

30, 30, 30, 06, 14, 14, 14, 14, 14, 14, 14, 14, 13, 13, 13, 13, 15, 15, 15, 15, 05, 20, 20, 20, 18, 18, 18, 18, 15, 15,

1999 1999 1999 2006 2011 2011 2011 2011 2011 2011 2011 2011 2009 2009 2009 2009 2009 2009 2009 2009 2010 2009 2009 2009 2011 2011 2011 2011 2009 2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

LEVETIRACETAM
TABLET; ORAL LEVETIRACETAM COBALT LABS INC AB DR REDDYS LABS LTD AB AB AB AB HETERO DRUGS LTD AB AB AB AB INVAGEN PHARMS AB AB AB LUPIN AB AB AB AB METHAPHARM AB AB AB AB MYLAN AB AB AB AB ORCHID HLTHCARE AB AB AB AB ROXANE AB AB AB AB SANDOZ AB AB AB AB SOLCO HLTHCARE AB AB AB AB TARO AB AB AB AB TEVA PHARMS AB AB AB AB TORRENT PHARMS AB AB AB AB VINTAGE PHARMS AB AB AB AB WATSON LABS AB

3 - 250 (of 424)

750MG 250MG 500MG 750MG 1GM 250MG 500MG 750MG 1GM 250MG 500MG 750MG 250MG 500MG 750MG 1GM 250MG 500MG 750MG 1GM 250MG 500MG 750MG 1GM 250MG 500MG 750MG 1GM 250MG 500MG 750MG 1GM 250MG 500MG 750MG 1GM 250MG 500MG 750MG 1GM 250MG 500MG 750MG 1GM 250MG 500MG 750MG 1GM 250MG 500MG 750MG 1GM 250MG 500MG 750MG 1GM 1GM

A077384 A076920 A076920 A076920 A078904 A090515 A090515 A090515 A090515 A078234 A078234 A078234 A078154 A078154 A078154 A090025 A090767 A090767 A090767 A090767 A076919 A076919 A076919 A090261 A078526 A078526 A078526 A090484 A078042 A078042 A078042 A078042 A077324 A077324 A077324 A077324 A078106 A078106 A078106 A078106 A078960 A078960 A078960 A078960 A078101 A078101 A078101 A078101 A078858 A078858 A078858 A078858 A091491 A091491 A091491 A091491 A078797

003 001 002 003 001 001 002 003 004 001 002 003 001 002 003 001 001 002 003 004 001 002 003 001 001 002 003 001 001 002 003 004 001 002 003 004 001 002 003 004 004 003 002 001 001 002 003 004 001 002 003 004 001 002 003 004 001

Jan Jan Jan Jan Jan Oct Oct Oct Oct Jan Jan Jan Jan Jan Jan Jan Jul Jul Jul Jul Nov Nov Nov Dec Jan Jan Jan Aug Jan Jan Jan Jan Jan Jan Jan Jan Feb Feb Feb Feb Feb Feb Feb Feb Jan Jan Jan Jan Jan Jan Jan Jan Dec Dec Dec Dec Jan

15, 15, 15, 15, 15, 08, 08, 08, 08, 15, 15, 15, 15, 15, 15, 15, 28, 28, 28, 28, 04, 04, 04, 08, 15, 15, 15, 05, 15, 15, 15, 15, 15, 15, 15, 15, 10, 10, 10, 10, 01, 01, 01, 01, 15, 15, 15, 15, 15, 15, 15, 15, 14, 14, 14, 14, 15,

2009 2009 2009 2009 2009 2010 2010 2010 2010 2009 2009 2009 2009 2009 2009 2009 2010 2010 2010 2010 2008 2008 2008 2009 2009 2009 2009 2010 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2010 2010 2010 2010 2009 2009 2009 2009 2009 2009 2009 2009 2010 2010 2010 2010 2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

LEVETIRACETAM
TABLET; ORAL LEVETIRACETAM WOCKHARDT AB AB AB AB ZYDUS PHARMS USA INC AB AB TABLET, EXTENDED RELEASE; KEPPRA XR UCB INC AB AB + LEVETIRACETAM ACTAVIS ELIZABETH AB AB ANCHEN PHARMS AB AB APOTEX INC AB AB LUPIN LTD AB AB MUTUAL PHARM CO INC AB AB MYLAN PHARMS INC AB AB PAR PHARM AB AB TEVA PHARMS AB AB WATSON LABS FLORIDA AB AB

3 - 251 (of 424)

250MG 500MG 750MG 1GM 250MG 1GM ORAL 500MG 750MG 500MG 750MG 500MG 750MG 500MG 750MG 500MG 750MG 500MG 750MG 500MG 750MG 500MG 750MG 500MG 750MG 500MG 750MG

A079042 A079042 A079042 A079042 A078918 A078918

001 002 003 004 001 002

Jan Jan Jan Jan Apr Apr

15, 15, 15, 15, 29, 29,

2009 2009 2009 2009 2009 2009

N022285 001 N022285 002 A091557 A091557 A091360 A091360 A091261 A091261 A091399 A091399 A091285 A091285 A200475 A200475 A091291 A091291 A091430 A091430 A091093 A091093 001 002 001 002 001 002 001 002 001 002 001 002 001 002 001 002 001 002

Sep 12, 2008 Feb 12, 2009 Sep Sep Oct Oct Sep Sep Sep Sep Sep Sep Dec Dec Sep Sep Sep Sep Sep Sep 12, 12, 04, 04, 12, 12, 12, 12, 12, 12, 19, 19, 12, 12, 12, 12, 12, 12, 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011

LEVOBUNOLOL HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC AKBETA AKORN AT 0.25% AT 0.5% BETAGAN AT + ALLERGAN 0.25% AT + 0.5% LEVOBUNOLOL HYDROCHLORIDE BAUSCH AND LOMB AT 0.25% AT 0.5% FALCON PHARMS AT 0.25% AT 0.5% NOVEX AT 0.25% AT 0.5%

A074779 001 A074780 001 N019814 001 N019219 002 A074307 A074326 A074851 A074850 A075473 A075475 001 001 001 001 001 001

Oct 29, 1996 Oct 29, 1996 Jun 28, 1989 Dec 19, 1985 Mar Mar Oct Oct Aug Aug 04, 04, 28, 28, 03, 03, 1994 1994 1996 1996 2000 2000

LEVOCARNITINE
INJECTABLE; INJECTION CARNITOR + SIGMA TAU LEVOCARNITINE BEDFORD LUITPOLD TEVA PARENTERAL

AP AP AP AP

200MG/ML 200MG/ML 200MG/ML 200MG/ML

N020182 001 A075567 001 A075861 001 A075881 001

Dec 16, 1992 Mar 29, 2001 Jun 22, 2001 Mar 29, 2001

SOLUTION; ORAL CARNITOR AA + SIGMA TAU

1GM/10ML

N019257 001

Apr 10, 1986

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

LEVOCARNITINE
SOLUTION; ORAL CARNITOR SF SIGMA TAU AA LEVOCARNITINE HI TECH PHARMA AA LYNE AA TABLET; ORAL CARNITOR AB + SIGMA TAU LEVOCARNITINE COREPHARMA AB

3 - 252 (of 424)

1GM/10ML 1GM/10ML 1GM/10ML

N019257 002 A077399 001 A076851 001

Mar 28, 2007 Oct 25, 2007 Aug 10, 2004

330MG 330MG

N018948 001 A076858 001

Dec 27, 1985 Sep 20, 2004

LEVOCETIRIZINE DIHYDROCHLORIDE
SOLUTION; ORAL LEVOCETIRIZINE DIHYDROCHLORIDE SYNTHON PHARMS AA 2.5MG/5ML XYZAL AA + UCB INC 2.5MG/5ML TABLET; ORAL LEVOCETIRIZINE DIHYDROCHLORIDE DR REDDYS LABS LTD 5MG GLENMARK GENERICS 5MG SYNTHON PHARMS 5MG TEVA PHARMS 5MG XYZAL + UCB INC 5MG

A091263 001 N022157 001

Nov 07, 2011 Jan 28, 2008

AB AB AB AB AB

A090392 A090385 A090229 A090199

001 001 001 001

Feb Feb Nov Aug

24, 24, 26, 22,

2011 2011 2010 2011

N022064 001

May 25, 2007

LEVOFLOXACIN
INJECTABLE; INJECTION LEVAQUIN + JANSSEN PHARMS EQ 500MG/20ML (EQ 25MG/ML) + EQ 750MG/30ML (EQ 25MG/ML) LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER + JANSSEN PHARMS EQ 250MG/50ML (EQ 5MG/ML) + EQ 500MG/100ML (EQ 5MG/ML) + EQ 750MG/150ML (EQ 5MG/ML) LEVOFLOXACIN AKORN EQ 500MG/20ML (EQ 25MG/ML) EQ 750MG/30ML (EQ 25MG/ML) SAGENT PHARMS EQ 500MG/20ML (EQ 25MG/ML) EQ 750MG/30ML (EQ 25MG/ML) LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ACS DOBFAR INFO SA EQ 250MG/50ML (EQ 5MG/ML) EQ 500MG/100ML (EQ 5MG/ML) EQ 750MG/150ML (EQ 5MG/ML) HIKMA FARMACEUTICA EQ 250MG/50ML (EQ 5MG/ML) EQ 500MG/100ML (EQ5MG/ML) EQ 750MG/150ML (EQ 5MG/ML)

AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP

N020635 001 N020635 004 N020635 002 N020635 003 N020635 005 A091644 A091644 A200560 A200560 A090343 A090343 A090343 A091375 A091375 A091375 001 002 001 002 001 002 003 001 002 003

Dec 20, 1996 Dec 20, 1996 Dec 20, 1996 Dec 20, 1996 Dec 20, 1996 Jun Jun Jun Jun Jul Jul Jul Sep Sep Sep 20, 20, 20, 20, 07, 07, 07, 16, 16, 16, 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011

SOLUTION; ORAL LEVAQUIN AA + JANSSEN PHARMS LEVOFLOXACIN HI TECH PHARMA AA

250MG/10ML 250MG/10ML

N021721 001 A091678 001

Oct 21, 2004 Jun 20, 2011

SOLUTION/DROPS; OPHTHALMIC LEVOFLOXACIN AKORN AT 0.5% APOTEX AT 0.5% HI TECH PHARMA AT 0.5%

A090268 001 A078282 001 A076826 001

Dec 20, 2010 Dec 20, 2010 Feb 10, 2011

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

LEVOFLOXACIN
SOLUTION/DROPS; OPHTHALMIC LEVOFLOXACIN NEXUS PHARMS AT 0.5% QUIXIN AT + SANTEN 0.5% IQUIX 1.5% XX + SANTEN TABLET; ORAL LEVAQUIN JANSSEN PHARMS AB AB AB + LEVOFLOXACIN APOTEX INC AB AB AB AUROBINDO PHARMA LTD AB AB AB DR REDDYS LABS INC AB AB AB GLENMARK GENERICS AB AB AB LUPIN AB AB AB MYLAN AB AB AB SANDOZ AB AB AB TEVA AB AB AB TORRENT PHARMS AB AB AB WOCKHARDT AB AB AB

3 - 253 (of 424)

A077700 001 N021199 001 N021571 001

Dec 20, 2010 Aug 18, 2000 Mar 01, 2004

250MG 500MG 750MG 250MG 500MG 750MG 250MG 500MG 750MG 250MG 500MG 750MG 250MG 500MG 750MG 250MG 500MG 750MG 250MG 500MG 750MG 250MG 500MG 750MG 250MG 500MG 750MG 250MG 500MG 750MG 250MG 500MG 750MG

N020634 001 N020634 002 N020634 003 A090787 A090787 A090787 A201043 A201043 A201043 A076710 A076710 A076710 A200250 A200250 A200250 A078424 A078424 A078424 A076276 A076276 A077097 A077438 A077438 A077438 A076361 A076361 A076361 A090722 A090722 A090722 A090367 A090367 A090367 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 001 002 001 001 002 003 001 002 003 001 002 003 001 002 003

Dec 20, 1996 Dec 20, 1996 Sep 08, 2000 Sep Sep Sep Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun 29, 29, 29, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20, 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011

LEVOLEUCOVORIN CALCIUM
POWDER; IV (INFUSION)

FUSILEV

XX + SPECTRUM PHARMS SOLUTION; IV (INFUSION)
FUSILEV
XX + SPECTRUM PHARMS XX +

EQ 50MG BASE/VIAL

N020140 001

Mar 07, 2008

EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) EQ 250MG BASE/25ML (EQ 10MG BASE/ML)

N020140 002 N020140 003

Apr 29, 2011 Apr 29, 2011

LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE

INJECTABLE; INJECTION ISOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN NOVOCOL AP 0.05MG/ML;2% SCANDONEST L DEPROCO AP 0.05MG/ML;2%

A084697 001 A088388 001 Oct 10, 1984

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

LEVONORGESTREL

INTRAUTERINE DEVICE; INTRAUTERINE

MIRENA
52MG XX + BAYER HLTHCARE TABLET; ORAL LEVONORGESTREL PERRIGO R AND D AB AB + WATSON LABS AB PLAN B AB + TEVA WOMENS PLAN B ONE-STEP XX + DURAMED

3 - 254 (of 424)

N021225 001

Dec 06, 2000

0.75MG 0.75MG 0.75MG 0.75MG 1.5MG

A090740 001 A078665 001 A078666 001 N021045 002 N021998 001

Dec 30, 2010 Aug 28, 2009 Jun 24, 2009 Aug 24, 2006 Jul 10, 2009

LEVORPHANOL TARTRATE
TABLET; ORAL LEVORPHANOL TARTRATE ROXANE XX

2MG

A074278 001

Mar 31, 2000

LEVOTHYROXINE SODIUM**

**Refer to Preface Section 1.8 Levothyroxine Sodium for amplifying information**

CAPSULE; ORAL TIROSINT INST BIOCHIMIQUE XX INSTITUT BIOCHIMIQUE XX XX XX XX XX XX XX XX XX + POWDER; INTRAVENOUS

LEVOTHYROXINE SODIUM

XX + APP PHARMS XX + XX + TABLET; ORAL LEVO-T --> ALARA PHARM --> --> --> --> --> --> --> --> --> --> --> + LEVOTHYROXINE SODIUM --> MERCK KGAA --> --> --> --> -->

0.013MG 0.025MG 0.05MG 0.075MG 0.088MG 0.1MG 0.112MG 0.125MG 0.137MG 0.15MG

N022121 N021924 N021924 N021924 N021924 N021924 N021924 N021924 N021924 N021924

001 002 003 004 010 005 008 006 009 007

Aug Oct Oct Oct Oct Oct Oct Oct Oct Oct

01, 13, 13, 13, 02, 13, 02, 13, 02, 13,

2007 2006 2006 2006 2009 2006 2009 2006 2009 2006

100MCG/VIAL 200MCG/VIAL 500MCG/VIAL

N202231 001 N202231 002 N202231 003

Jun 24, 2011 Jun 24, 2011 Jun 24, 2011

--> --> --> --> --> --> --> --> --> --> --> --> --> --> --> --> --> -->

AB1,AB2,AB3 AB1,AB2,AB3 AB1,AB2,AB3 AB1,AB2,AB3 AB1,AB2,AB3 AB1,AB2,AB3 AB1,AB2,AB3 AB1,AB2,AB3 AB1,AB2,AB3 AB1,AB2,AB3 AB1,AB2,AB3 AB1,AB2,AB3 AB2,AB3 AB2,AB3 AB2,AB3 AB2,AB3 AB2,AB3 AB2,AB3

0.025MG 0.05MG 0.075MG 0.088MG 0.1MG 0.112MG 0.125MG 0.137MG 0.15MG 0.175MG 0.2MG 0.3MG

N021342 N021342 N021342 N021342 N021342 N021342 N021342 N021342 N021342 N021342 N021342 N021342 A076752 A076752 A076752 A076752 A076752 A076752

001 002 003 004 005 006 007 012 008 009 010 011 001 002 003 004 005 006

Mar Mar Mar Mar Mar Mar Mar Dec Mar Mar Mar Mar Jun Jun Jun Jun Jun Jun

01, 01, 01, 01, 01, 01, 01, 08, 01, 01, 01, 01, 16, 16, 16, 16, 16, 16,

2002 2002 2002 2002 2002 2002 2002 2003 2002 2002 2002 2002 2005 2005 2005 2005 2005 2005

0.025MG 0.05MG 0.075MG 0.088MG 0.1MG 0.112MG

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

LEVOTHYROXINE SODIUM**

3 - 255 (of 424)

**Refer to Preface Section 1.8 Levothyroxine Sodium for amplifying information**

TABLET; ORAL LEVOTHYROXINE SODIUM --> MERCK KGAA --> --> --> --> --> MYLAN --> --> --> --> --> --> --> --> --> --> --> LEVOXYL --> KING PHARMS --> --> --> --> --> --> --> --> --> --> + SYNTHROID --> ABBOTT --> --> --> --> --> --> --> --> --> --> --> + UNITHROID --> STEVENS J --> --> --> --> --> --> --> --> --> --> --> +

--> --> --> --> --> --> --> --> --> --> --> --> --> --> --> --> --> --> --> --> --> --> --> --> --> --> --> --> --> --> --> --> --> --> --> --> --> --> --> --> --> --> --> --> --> --> --> --> --> --> --> -->

AB2,AB3 0.125MG AB2,AB3 0.15MG AB2,AB3 0.175MG AB2,AB3 0.2MG AB2,AB3 0.3MG AB1,AB2,AB3,AB4 AB1,AB2,AB3,AB4 AB1,AB2,AB3,AB4 AB1,AB2,AB3,AB4 AB1,AB2,AB3,AB4 AB1,AB2,AB3,AB4 AB1,AB2,AB3,AB4 AB1,AB2,AB3,AB4 AB1,AB2,AB3,AB4 AB1,AB2,AB3,AB4 AB1,AB2,AB3,AB4 AB1,AB2,AB3,AB4 AB1,AB3 AB1,AB3 AB1,AB3 AB1,AB3 AB1,AB3 AB1,AB3 AB1,AB3 AB1,AB3 AB1,AB3 AB1,AB3 AB1,AB3 AB1,AB2 AB1,AB2 AB1,AB2 AB1,AB2 AB1,AB2 AB1,AB2 AB1,AB2 AB1,AB2 AB1,AB2 AB1,AB2 AB1,AB2 AB1,AB2 0.025MG 0.05MG 0.075MG 0.088MG 0.1MG 0.112MG 0.125MG 0.137MG 0.15MG 0.175MG 0.2MG 0.025MG 0.05MG 0.075MG 0.088MG 0.1MG 0.112MG 0.125MG 0.137MG 0.15MG 0.175MG 0.2MG 0.3MG

0.025MG 0.05MG 0.075MG 0.088MG 0.1MG 0.112MG 0.125MG 0.137MG 0.15MG 0.175MG 0.2MG 0.3MG

A076752 A076752 A076752 A076752 A076752 A076187 A076187 A076187 A076187 A076187 A076187 A076187 A076187 A076187 A076187 A076187 A076187 N021301 N021301 N021301 N021301 N021301 N021301 N021301 N021301 N021301 N021301 N021301 N021402 N021402 N021402 N021402 N021402 N021402 N021402 N021402 N021402 N021402 N021402 N021402 N021210 N021210 N021210 N021210 N021210 N021210 N021210 N021210 N021210 N021210 N021210 N021210

007 008 009 010 011 001 002 003 004 005 006 007 012 008 009 010 011 001 002 003 004 005 006 007 008 009 010 011 001 002 003 004 005 006 007 008 009 010 012 011 001 002 003 004 005 006 007 012 008 009 010 011

Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Dec Jun Jun Jun Jun May May May May May May May May May May May Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul Aug Aug Aug Aug Aug Aug Aug Feb Aug Aug Aug Aug

16, 16, 16, 16, 16, 05, 05, 05, 05, 05, 05, 05, 13, 05, 05, 05, 05, 25, 25, 25, 25, 25, 25, 25, 25, 25, 25, 25, 24, 24, 24, 24, 24, 24, 24, 24, 24, 24, 24, 24, 21, 21, 21, 21, 21, 21, 21, 08, 21, 21, 21, 21,

2005 2005 2005 2005 2005 2002 2002 2002 2002 2002 2002 2002 2006 2002 2002 2002 2002 2001 2001 2001 2001 2001 2001 2001 2001 2001 2001 2001 2002 2002 2002 2002 2002 2002 2002 2002 2002 2002 2002 2002 2000 2000 2000 2000 2000 2000 2000 2008 2000 2000 2000 2000

AB1,AB2,AB3 AB1,AB2,AB3 AB1,AB2,AB3 AB1,AB2,AB3 AB1,AB2,AB3 AB1,AB2,AB3 AB1,AB2,AB3 AB1,AB2,AB3 AB1,AB2,AB3 AB1,AB2,AB3 AB1,AB2,AB3 AB1,AB2,AB3

0.025MG 0.05MG 0.075MG 0.088MG 0.1MG 0.112MG 0.125MG 0.137MG 0.15MG 0.175MG 0.2MG 0.3MG

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

LEVOTHYROXINE SODIUM**

3 - 256 (of 424)

**Refer to Preface Section 1.8 Levothyroxine Sodium for amplifying information**

TABLET; ORAL LEVOTHROID LLOYD AB4 AB4 AB4 AB4 AB4 AB4 AB4 AB4 AB4 AB4 AB4 AB4 +

0.025MG 0.05MG 0.075MG 0.088MG 0.1MG 0.112MG 0.125MG 0.137MG 0.15MG 0.175MG 0.2MG 0.3MG

N021116 N021116 N021116 N021116 N021116 N021116 N021116 N021116 N021116 N021116 N021116 N021116

001 002 003 010 004 011 005 012 006 007 008 009

Oct Oct Oct Oct Oct Oct Oct Dec Oct Oct Oct Oct

24, 24, 24, 24, 24, 24, 24, 07, 24, 24, 24, 24,

2002 2002 2002 2002 2002 2002 2002 2004 2002 2002 2002 2002

LIDOCAINE
OINTMENT; TOPICAL LIDOCAINE AT + FOUGERA NOVOCOL INC AT TARO AT PATCH; TOPICAL

LIDODERM

XX + TEIKOKU PHARMA USA

5% 5% 5%

A080198 001 A040911 001 A086724 001

May 23, 2011

5%

N020612 001

Mar 19, 1999

LIDOCAINE HYDROCHLORIDE
GEL; OPHTHALMIC

AKTEN

XX + AKORN INJECTABLE; INJECTION LIDOCAINE HYDROCHLORIDE HOSPIRA AP AP AP AP AP AP AP LUITPOLD AP AP STRIDES ARCOLAB LTD AP AP AP AP LIDOCAINE HYDROCHLORIDE B BRAUN AP BAXTER HLTHCARE AP LIDOCAINE HYDROCHLORIDE B BRAUN AP BAXTER HLTHCARE AP LIDOCAINE HYDROCHLORIDE HOSPIRA AP LIDOCAINE HYDROCHLORIDE B BRAUN AP BAXTER HLTHCARE AP LIDOCAINE HYDROCHLORIDE HOSPIRA AP

3.5%

N022221 001

Oct 07, 2008

0.5% 1% 1% 2% 2% 2% 20% 1% 2% 0.5% 0.5% 1% 1% 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER 200MG/100ML 200MG/100ML 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER 400MG/100ML 400MG/100ML 0.4% IN DEXTROSE 5% IN PLASTIC CONTAINER 400MG/100ML 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER 800MG/100ML 800MG/100ML 0.8% IN DEXTROSE 5% IN PLASTIC CONTAINER 800MG/100ML

A088328 A083158 A088329 A040078 A083158 A088294 A083158 A080850 A083198 A091056 A091058 A091056 A091058

001 001 001 001 002 001 003 001 001 001 001 002 002

May 17, 1984 May 17, 1984 Jun 23, 1995 May 17, 1984

Dec Sep Dec Sep

08, 30, 08, 30,

2010 2010 2010 2010

N019830 002 N018461 002 N019830 003 N018461 003 N018388 002 N019830 004 N018461 004 N018388 003

Apr 08, 1992

Apr 08, 1992

Apr 08, 1992 Feb 22, 1982 Nov 05, 1982

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

LIDOCAINE HYDROCHLORIDE
INJECTABLE; INJECTION LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER APP PHARMS 1% AP HOSPIRA AP 0.5% AP 1% AP 2% LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE ABRAXIS PHARM AP 2% AP 4% APP PHARMS AP 1% AP 2% HOSPIRA AP 1% AP 1.5% 4% AP INTL MEDICATION 20% AP STRIDES ARCOLAB LTD AP 2% LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE IN PLASTIC CONTAINER HOSPIRA AP 1% AP 2% LIDOPEN MERIDIAN MEDCL TECHN 10% AP XYLOCAINE AP + APP PHARMS 0.5% AP + 1% AP + 1.5% AP + 2% XYLOCAINE 4% PRESERVATIVE FREE AP + APP PHARMS 4% XYLOCAINE DENTAL AP + DENTSPLY PHARM 2% XYLOCAINE PRESERVATIVE FREE AP + APP PHARMS 1% AP + 2% AP + 4% AP + 10% AP + 20% INJECTABLE; SPINAL
LIDOCAINE HYDROCHLORIDE 5% AND DEXTROSE 7.5%
5% XX + HOSPIRA JELLY; TOPICAL ANESTACON POLYMEDICA LIDOCAINE HYDROCHLORIDE AKORN HI TECH PHARMA INTL MEDICATION TEVA PHARMS XYLOCAINE + OAK PHARMS SOLUTION; ORAL LIDOCAINE HYDROCHLORIDE HI TECH PHARMA WOCKHARDT LIDOCAINE HYDROCHLORIDE VINTAGE LIDOCAINE VISCOUS ROXANE XYLOCAINE VISCOUS + APP PHARMS

3 - 257 (of 424)

A088586 A088325 A088299 A088327 N017584 N017584 A080404 A080404 A080408 A080408 A088295 N017702 A090665

001 001 001 001 001 002 002 003 001 002 001 001 001

Jul Jul Jul Jul

24, 31, 31, 31,

1985 1984 1984 1984

May 17, 1984 Sep 27, 2010 Sep 28, 1998 Sep 28, 1998

A040302 001 A040302 002 N017549 001 N006488 N006488 N006488 N006488 008 007 010 002

N010417 001 N021380 001 N016801 N016801 N016801 N016801 N016801 005 001 002 003 004 Jan 19, 1988

A083914 001

AT AT AT AT AT AT

2% 2% 2% 2% 2% 2%

A080429 001 A040433 A040837 A086283 A081318 001 001 001 001 Feb 12, 2003 Mar 23, 2011 Apr 29, 1993

N008816 001

AT AT AT AT AT

2% 2% VISCOUS 2% 2% 2%

A040014 001 A087872 001 A040708 001 A088802 001 N009470 001

Jul 10, 1995 Nov 18, 1982 Feb 27, 2007 Apr 26, 1985

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

LIDOCAINE HYDROCHLORIDE
SOLUTION; TOPICAL LARYNG-O-JET KIT INTL MEDICATION 4% LIDOCAINE HYDROCHLORIDE ROXANE 4% VINTAGE 4% WOCKHARDT 4% LTA II KIT HOSPIRA 4% XYLOCAINE 4% PRESERVATIVE FREE + APP PHARMS 4%

3 - 258 (of 424)

AT AT AT AT AT AT

A086364 001 A088803 001 A040710 001 A087881 001 A080409 001 N010417 002 Apr 03, 1985 Feb 27, 2007 Nov 18, 1982

LIDOCAINE; PRILOCAINE
CREAM; TOPICAL EMLA + OAK PHARMS 2.5%;2.5% LIDOCAINE AND PRILOCAINE HI TECH PHARMA 2.5%;2.5% NYCOMED US 2.5%;2.5% TOLMAR 2.5%;2.5%

AB AB AB AB

N019941 001 A076290 001 A076453 001 A076320 001

Dec 30, 1992 Sep 25, 2003 Aug 18, 2003 Aug 27, 2003

GEL; PERIODONTAL

ORAQIX
XX + DENTSPLY PHARM

2.5%;2.5%

N021451 001

Dec 19, 2003

LIDOCAINE; TETRACAINE
CREAM; TOPICAL

LIDOCAINE AND TETRACAINE

7%;7% XX + GALDERMA LABS LP PATCH; TOPICAL

SYNERA

XX + ZARS PHARM

N021717 001

Jun 29, 2006

70MG;70MG

N021623 001

Jun 23, 2005

LINAGLIPTIN
TABLET; ORAL

TRADJENTA

XX + BOEHRINGER INGELHEIM

5MG

N201280 001

May 02, 2011

LINCOMYCIN HYDROCHLORIDE
INJECTABLE; INJECTION

LINCOCIN

XX + PHARMACIA AND UPJOHN

EQ 300MG BASE/ML

N050317 001

LINDANE
LOTION; TOPICAL LINDANE OLTA PHARMS AT AT + WOCKHARDT SHAMPOO; TOPICAL LINDANE OLTA PHARMS AT AT + WOCKHARDT

1% 1%

A087313 001 A088190 001

Aug 16, 1984

1% 1%

A087266 001 A088191 001

Sep 18, 1984

LINEZOLID
FOR SUSPENSION; ORAL

ZYVOX

XX + PHARMACIA AND UPJOHN

100MG/5ML

N021132 001

Apr 18, 2000

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

LINEZOLID
INJECTABLE; INJECTION

ZYVOX

XX + PHARMACIA AND UPJOHN TABLET; ORAL

ZYVOX

XX + PHARMACIA AND UPJOHN

3 - 259 (of 424)

200MG/100ML

N021131 001

Apr 18, 2000

600MG

N021130 002

Apr 18, 2000

LIOTHYRONINE SODIUM
INJECTABLE; INJECTION LIOTHYRONINE SODIUM X GEN PHARMS AP TRIOSTAT AP + JHP PHARMS TABLET; ORAL CYTOMEL KING PHARMS AB AB AB + LIOTHYRONINE SODIUM COASTAL PHARMS AB AB AB MYLAN AB AB AB

EQ 0.01MG BASE/ML EQ 0.01MG BASE/ML

A076923 001 N020105 001

Aug 17, 2005 Dec 31, 1991

EQ 0.005MG BASE EQ 0.025MG BASE EQ 0.05MG BASE EQ EQ EQ EQ EQ EQ 0.005MG BASE 0.025MG BASE 0.05MG BASE 0.005MG BASE 0.025MG BASE 0.05MG BASE

N010379 001 N010379 002 N010379 003 A090097 A090097 A090097 A090326 A090326 A090326 001 002 003 001 002 003 Mar Mar Mar Jul Jul Jul 20, 20, 20, 14, 14, 14, 2009 2009 2009 2009 2009 2009

LIOTRIX (T4;T3)
TABLET; ORAL

THYROLAR-0.25

FOREST LABS THYROLAR-0.5

FOREST LABS THYROLAR-1

FOREST LABS THYROLAR-2

FOREST LABS THYROLAR-3

+ FOREST LABS

XX XX XX XX XX

0.0125MG;0.0031MG 0.025MG;0.0063MG 0.05MG;0.0125MG 0.1MG;0.025MG 0.15MG;0.0375MG

N016807 001

N016807 005

N016807 004

N016807 002

N016807 003

LIRAGLUTIDE RECOMBINANT
SOLUTION; SUBCUTANEOUS

VICTOZA

XX + NOVO NORDISK INC

18MG/3ML (6MG/ML)

N022341 001

Jan 25, 2010

LISDEXAMFETAMINE DIMESYLATE
CAPSULE; ORAL VYVANSE XX SHIRE DEVELOPMENT XX XX XX XX XX +

20MG 30MG 40MG 50MG 60MG 70MG

N021977 N021977 N021977 N021977 N021977 N021977

004 001 005 002 006 003

Dec Feb Dec Feb Dec Feb

10, 23, 10, 23, 10, 23,

2007 2007 2007 2007 2007 2007

LISINOPRIL
TABLET; ORAL LISINOPRIL APOTEX INC AB

2.5MG

A076102 001

Sep 30, 2002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

LISINOPRIL
TABLET; ORAL LISINOPRIL APOTEX INC AB AB AB AB AB AUROBINDO AB AB AB AB AB AB IVAX SUB TEVA PHARMS AB AB AB AB AB AB LEK PHARMS AB AB AB AB AB AB LUPIN AB AB AB AB AB AB MYLAN AB AB AB AB AB AB PRINSTON INC AB AB AB AB AB AB RANBAXY AB AB AB AB AB AB SANDOZ AB AB AB AB AB AB AB AB AB AB

3 - 260 (of 424)

5MG 10MG 20MG 30MG 40MG 2.5MG 5MG 10MG 20MG 30MG 40MG 2.5MG 5MG 10MG 20MG 30MG 40MG 2.5MG 5MG 10MG 20MG 30MG 40MG 2.5MG 5MG 10MG 20MG 30MG 40MG 2.5MG 5MG 10MG 20MG 30MG 40MG 2.5MG 5MG 10MG 20MG 30MG 40MG 2.5MG 5MG 10MG 20MG 30MG 40MG 2.5MG 2.5MG 5MG 5MG 10MG 10MG 20MG 20MG 30MG 30MG

A076102 A076102 A076102 A076102 A076102 A077622 A077622 A077622 A077622 A077622 A077622 A075752 A075752 A075752 A075752 A075752 A075752 A075999 A075999 A075999 A075999 A075999 A075999 A077321 A077321 A077321 A077321 A077321 A077321 A076071 A076071 A076071 A076071 A076071 A076071 A076180 A076180 A076180 A076164 A076164 A076164 A075944 A075944 A075944 A075944 A075944 A075944 A075903 A075994 A075903 A075994 A075903 A075994 A075903 A075994 A075903 A075994

002 003 004 005 006 001 002 003 004 005 006 001 002 003 004 005 006 001 002 003 004 005 006 001 002 003 004 005 006 001 002 003 004 005 006 001 002 003 001 002 003 001 002 003 004 006 005 001 001 002 002 003 003 004 004 005 005

Sep Sep Sep Sep Sep Feb Feb Feb Feb Feb Feb Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul Sep Sep Sep Sep Sep Sep Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul Feb Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul

30, 30, 30, 30, 30, 22, 22, 22, 22, 22, 22, 01, 01, 01, 01, 01, 01, 01, 01, 01, 01, 01, 01, 09, 09, 09, 09, 09, 09, 01, 01, 01, 01, 01, 01, 01, 01, 01, 01, 01, 01, 01, 01, 01, 01, 11, 01, 01, 01, 01, 01, 01, 01, 01, 01, 01, 01,

2002 2002 2002 2002 2002 2006 2006 2006 2006 2006 2006 2002 2002 2002 2002 2002 2002 2002 2002 2002 2002 2002 2002 2005 2005 2005 2005 2005 2005 2002 2002 2002 2002 2002 2002 2002 2002 2002 2002 2002 2002 2002 2002 2002 2002 2003 2002 2002 2002 2002 2002 2002 2002 2002 2002 2002 2002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

LISINOPRIL
TABLET; ORAL LISINOPRIL SANDOZ AB AB VINTAGE AB AB AB AB AB AB WATSON LABS AB AB AB AB AB AB WEST WARD AB AB AB AB AB AB WOCKHARDT AB AB AB AB AB AB PRINIVIL MERCK AB AB AB AB ZESTRIL ASTRAZENECA AB AB AB AB AB AB +

3 - 261 (of 424)

40MG 40MG 2.5MG 5MG 10MG 20MG 30MG 40MG 2.5MG 5MG 10MG 20MG 30MG 40MG 2.5MG 5MG 10MG 20MG 30MG 40MG 2.5MG 5MG 10MG 20MG 30MG 40MG 5MG 10MG 20MG 40MG 2.5MG 5MG 10MG 20MG 30MG 40MG

A075903 A075994 A075743 A075743 A075743 A075743 A075743 A075743 A076059 A076059 A076059 A076059 A076059 A076059 A076063 A076063 A076063 A076063 A076063 A076063 A078402 A078402 A078402 A078402 A078402 A078402 N019558 N019558 N019558 N019558 N019777 N019777 N019777 N019777 N019777 N019777

006 006 001 002 003 004 005 006 001 002 003 004 005 006 001 002 003 004 006 005 001 002 003 004 005 006 001 002 003 004 005 001 002 003 006 004

Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul Jun Jul Apr Apr Apr Apr Apr Apr Dec Dec Dec Oct Apr May May May Jan May

01, 01, 01, 01, 01, 01, 01, 01, 01, 01, 01, 01, 01, 01, 01, 01, 01, 01, 27, 01, 19, 19, 19, 19, 19, 19, 29, 29, 29, 25, 29, 19, 19, 19, 20, 19,

2002 2002 2002 2002 2002 2002 2002 2002 2002 2002 2002 2002 2002 2002 2002 2002 2002 2002 2003 2002 2007 2007 2007 2007 2007 2007 1987 1987 1987 1988 1993 1988 1988 1988 1999 1988

LITHIUM CARBONATE

CAPSULE; ORAL
LITHIUM CARBONATE ALEMBIC LTD AB AB AB APOTEX INC AB GLENMARK GENERICS AB AB AB HETERO DRUGS LTD AB AB AB ROXANE AB AB AB + WEST WARD AB AB

150MG 300MG 600MG 300MG 150MG 300MG 600MG 150MG 300MG 600MG 150MG 300MG 600MG 150MG 300MG

A079159 A079159 A079159 A076795 A079139 A079139 A079139 A090702 A090702 A090702 N017812 N017812 N017812 A076243 A076243

001 002 003 001 001 002 003 001 002 003 002 001 003 002 001

Jan Jan Jan Nov Feb Feb Feb Sep Sep Sep Jan

12, 12, 12, 22, 03, 03, 03, 25, 25, 25, 28,

2009 2009 2009 2004 2009 2009 2009 2009 2009 2009 1987

Jan 28, 1987 Feb 24, 2003 Jun 27, 2002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

LITHIUM CARBONATE
CAPSULE; ORAL LITHIUM CARBONATE WEST WARD AB TABLET; ORAL LITHIUM CARBONATE AB + ROXANE SUN PHARM INDS INC AB WEST WARD AB

3 - 262 (of 424)

600MG

A078763 001

Apr 15, 2008

300MG 300MG 300MG

N018558 001 A091027 001 A078715 001

Jan 29, 1982 Jun 24, 2010 Dec 28, 2010

TABLET, EXTENDED RELEASE; ORAL LITHIUM CARBONATE GLENMARK GENERICS AB 300MG AB 450MG ROXANE AB 300MG AB + 450MG WEST WARD AB 450MG LITHOBID AB + NOVEN THERAP 300MG

A091544 A091616 A076832 A076691 A076490

001 001 001 001 001

Dec Feb Oct Jan Jun

27, 14, 28, 05, 17,

2010 2011 2004 2004 2003

N018027 001

LITHIUM CITRATE
SYRUP; ORAL LITHIUM CITRATE AA + ROXANE WOCKHARDT AA

EQ 300MG CARBONATE/5ML EQ 300MG CARBONATE/5ML

N018421 001 A070755 001

May 21, 1986

LODOXAMIDE TROMETHAMINE
SOLUTION/DROPS; OPHTHALMIC
ALOMIDE
XX + ALCON EQ 0.1% BASE

N020191 001

Sep 23, 1993

LOMUSTINE

CAPSULE; ORAL

CEENU
BRISTOL MYERS SQUIBB XX XX XX +

10MG 40MG 100MG

N017588 001

N017588 002
N017588 003

LOPERAMIDE HYDROCHLORIDE
CAPSULE; ORAL IMODIUM AB + MCNEIL CONS 2MG LOPERAMIDE HYDROCHLORIDE MYLAN AB 2MG TEVA AB 2MG

N017694 001 A072741 001 A073192 001 Sep 18, 1991 Apr 30, 1992

LOPINAVIR; RITONAVIR

CAPSULE; ORAL

KALETRA
XX + ABBOTT
SOLUTION; ORAL

KALETRA
XX + ABBOTT TABLET; ORAL KALETRA XX ABBOTT XX +

133.3MG;33.3MG

N021226 001

Sep 15, 2000

80MG/ML;20MG/ML

N021251 001

Sep 15, 2000

100MG;25MG 200MG;50MG

N021906 002 N021906 001

Nov 09, 2007 Oct 28, 2005

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

LORAZEPAM
CONCENTRATE; ORAL LORAZEPAM AMNEAL PHARMS PADDOCK LLC PHARM ASSOC LORAZEPAM INTENSOL + ROXANE

3 - 263 (of 424)

AA AA AA AA

2MG/ML 2MG/ML 2MG/ML 2MG/ML

A091383 001 A079244 001 A090260 001 A072755 001

Dec 23, 2009 Apr 28, 2009 Jun 15, 2010 Jun 28, 1991

INJECTABLE; INJECTION ATIVAN AP + BAXTER HLTHCARE CORP 2MG/ML AP + 4MG/ML LORAZEPAM BEDFORD 2MG/ML AP 4MG/ML AP HOSPIRA 2MG/ML AP 2MG/ML AP 2MG/ML AP 4MG/ML AP 4MG/ML AP INTL MEDICATION SYS AP 2MG/ML TAYLOR AP 2MG/ML WATSON LABS AP 2MG/ML AP 4MG/ML LORAZEPAM PRESERVATIVE FREE BEDFORD LABS AP 2MG/ML AP 4MG/ML TABLET; ORAL ATIVAN VALEANT INTL AB AB AB + LORAZEPAM ACTAVIS ELIZABETH AB AB AB AMNEAL PHARMS AB AB AB EXCELLIUM AB AB AB IVAX SUB TEVA PHARMS AB AB AB MYLAN AB AB AB AB AB AB RANBAXY AB AB AB SANDOZ AB AB AB VINTAGE PHARMS AB AB AB

N018140 001 N018140 002 A077076 A077076 A074243 A074282 A074300 A074243 A074282 A076150 A075025 A074276 A074276 001 002 001 001 001 002 002 001 001 001 002 Jul Jul Apr May Apr Apr May Nov Jul Apr Apr 13, 13, 12, 27, 12, 12, 27, 15, 23, 15, 15, 2005 2005 1994 1994 1994 1994 1994 2004 1998 1994 1994

A077074 001 A077074 002

Jul 13, 2005 Jul 13, 2005

0.5MG 1MG 2MG 0.5MG 1MG 2MG 0.5MG 1MG 2MG 0.5MG 1MG 2MG 0.5MG 1MG 2MG 0.5MG 0.5MG 1MG 1MG 2MG 2MG 0.5MG 1MG 2MG 0.5MG 1MG 2MG 0.5MG 1MG 2MG

N017794 001 N017794 002 N017794 003 A071403 A071404 A071141 A078826 A078826 A078826 A078203 A078203 A078203 A077396 A077396 A077396 A071589 A077657 A071590 A077657 A071591 A077657 A076045 A076045 A076045 A071193 A071194 A071195 A077754 A077754 A077754 001 001 001 001 002 003 001 002 003 001 002 003 001 001 001 002 001 003 001 002 003 001 001 001 001 002 003 Apr Apr Apr Jun Jun Jun Jul Jul Jul Dec Dec Dec Oct Mar Oct Mar Oct Mar Aug Aug Aug Apr Apr Apr May May May 21, 21, 21, 23, 23, 23, 30, 30, 30, 13, 13, 13, 13, 16, 13, 16, 13, 16, 29, 29, 29, 15, 15, 15, 10, 10, 10, 1987 1987 1987 2010 2010 2010 2007 2007 2007 2006 2006 2006 1987 2006 1987 2006 1987 2006 2001 2001 2001 1988 1988 1988 2006 2006 2006

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

LORAZEPAM
TABLET; ORAL LORAZEPAM WATSON LABS AB AB AB AB

3 - 264 (of 424)

0.5MG 1MG 1MG 2MG

A072926 A071118 A072927 A072928

001 001 001 001

Oct Jul Oct Oct

31, 24, 31, 31,

1991 1986 1991 1991

LOSARTAN POTASSIUM
TABLET; ORAL COZAAR MERCK AB AB AB + LOSARTAN POTASSIUM ACTAVIS INC AB AB AB ALEMBIC PHARMS LTD AB AB AB APOTEX CORP AB AB AB AUROBINDO PHARMA AB AB AB LUPIN LTD AB AB AB MYLAN AB AB AB PRINSTON INC AB AB AB ROXANE AB AB AB SANDOZ AB AB AB TEVA AB AB AB TORRENT PHARMS AB AB AB UPSHER SMITH AB AB AB WATSON LABS AB AB AB ZYDUS PHARMS USA INC AB AB AB

25MG 50MG 100MG 25MG 50MG 100MG 25MG 50MG 100MG 25MG 50MG 100MG 25MG 50MG 100MG 25MG 50MG 100MG 25MG 50MG 100MG 25MG 50MG 100MG 25MG 50MG 100MG 25MG 50MG 100MG 25MG 50MG 100MG 25MG 50MG 100MG 25MG 50MG 100MG 25MG 50MG 100MG 25MG 50MG 100MG

N020386 001 N020386 002 N020386 003 A090382 A090382 A090382 A090428 A090428 A090428 A090790 A090790 A090790 A090083 A090083 A090083 A078232 A078232 A078232 A091590 A091590 A091590 A091497 A091497 A091497 A077459 A077459 A077459 A077424 A077424 A077424 A076958 A076958 A076958 A090467 A090467 A090467 A090544 A090544 A090544 A091129 A091129 A091129 A078243 A078243 A078243 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003

Apr 14, 1995 Apr 14, 1995 Oct 13, 1998 Oct Oct Oct Oct Oct Oct Oct Oct Oct Oct Oct Oct Oct Oct Oct Oct Oct Oct Jun Jun Jun Oct Oct Oct Oct Oct Oct Apr Apr Apr Oct Oct Oct Oct Oct Oct Oct Oct Oct Oct Oct Oct 06, 06, 06, 06, 06, 06, 06, 06, 06, 06, 06, 06, 06, 06, 06, 06, 06, 06, 06, 06, 06, 06, 06, 06, 06, 06, 06, 06, 06, 06, 06, 06, 06, 06, 06, 06, 06, 06, 06, 06, 06, 06, 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2011 2011 2011 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

LOTEPREDNOL ETABONATE

OINTMENT; OPHTHALMIC

LOTEMAX
XX + BAUSCH AND LOMB

3 - 265 (of 424)

0.5%

N200738 001

Apr 15, 2011

SUSPENSION/DROPS; OPHTHALMIC

ALREX
0.2% XX + BAUSCH AND LOMB LOTEMAX 0.5% XX + BAUSCH AND LOMB

N020803 001 N020583 001

Mar 09, 1998 Mar 09, 1998

LOTEPREDNOL ETABONATE; TOBRAMYCIN

SUSPENSION/DROPS; OPHTHALMIC
ZYLET
XX + BAUSCH AND LOMB 0.5%;0.3%

N050804 001

Dec 14, 2004

LOVASTATIN
TABLET; ORAL LOVASTATIN ACTAVIS ELIZABETH AB AB AB APOTEX INC AB AB AB CARLSBAD AB AB AB LUPIN AB AB AB MUTUAL PHARM AB AB AB MYLAN AB AB AB AB AB AB SANDOZ AB AB AB AB AB AB TEVA AB AB AB MEVACOR MERCK AB AB +

10MG 20MG 40MG 10MG 20MG 40MG 10MG 20MG 40MG 10MG 20MG 40MG 10MG 20MG 40MG 10MG 10MG 20MG 20MG 40MG 40MG 10MG 10MG 20MG 20MG 40MG 40MG 10MG 20MG 40MG 20MG 40MG

A075828 A075828 A075828 A077748 A077748 A077748 A075991 A075991 A075991 A078296 A078296 A078296 A077520 A077520 A077520 A075451 A075935 A075451 A075935 A075451 A075935 A075300 A075636 A075300 A075636 A075300 A075636 A075551 A075551 A075551

001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 001 001 002 002 003 003 001 001 002 002 003 003 003 002 001

Dec Dec Dec Feb Feb Feb Jun Jun Jun Mar Nov Nov Apr Apr Apr Dec Dec Dec Dec Dec Dec Dec Dec Dec Dec Dec Dec Dec Dec Dec

17, 17, 17, 28, 28, 28, 05, 05, 05, 14, 01, 01, 14, 14, 14, 17, 17, 17, 17, 17, 17, 17, 17, 17, 17, 17, 17, 17, 17, 17,

2001 2001 2001 2007 2007 2007 2002 2002 2002 2008 2007 2007 2006 2006 2006 2001 2001 2001 2001 2001 2001 2001 2001 2001 2001 2001 2001 2001 2001 2001

N019643 003 N019643 004

Aug 31, 1987 Dec 14, 1988

TABLET, EXTENDED RELEASE; ORAL ALTOPREV ANDRX LABS LLC 20MG XX 40MG XX 60MG XX +

N021316 002 N021316 003 N021316 004

Jun 26, 2002 Jun 26, 2002 Jun 26, 2002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

LOVASTATIN; NIACIN
TABLET, EXTENDED RELEASE; ORAL

ADVICOR

+ ABBOTT 20MG;500MG + 20MG;750MG + 20MG;1GM + 40MG;1GM

3 - 266 (of 424)

XX XX XX XX

N021249 N021249 N021249 N021249

001 002 003 004

Dec Dec Dec Apr

17, 17, 17, 27,

2001 2001 2001 2006

LOXAPINE SUCCINATE
CAPSULE; ORAL LOXAPINE SUCCINATE LANNETT HOLDINGS INC AB AB AB AB MYLAN AB AB AB AB WATSON LABS AB AB AB + AB

EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ

5MG BASE 10MG BASE 25MG BASE 50MG BASE 5MG BASE 10MG BASE 25MG BASE 50MG BASE 5MG BASE 10MG BASE 25MG BASE 50MG BASE

A090695 A090695 A090695 A090695 A076762 A076762 A076762 A076762 A072204 A072205 A072206 A072062

001 002 003 004 001 002 003 004 001 001 001 001

Sep Sep Sep Sep Nov Nov Nov Nov Jun Jun Jun Jun

26, 26, 26, 26, 01, 01, 01, 01, 15, 15, 15, 15,

2011 2011 2011 2011 2004 2004 2004 2004 1988 1988 1988 1988

LUBIPROSTONE
CAPSULE; ORAL AMITIZA SUCAMPO PHARMS XX XX +

8MCG 24MCG

N021908 002 N021908 001

Apr 29, 2008 Jan 31, 2006

LURASIDONE HYDROCHLORIDE
TABLET; ORAL LATUDA SUNOVION XX XX +

40MG 80MG

N200603 001 N200603 002

Oct 28, 2010 Oct 28, 2010

LUTROPIN ALFA
INJECTABLE; SUBCUTANEOUS

LUVERIS

XX + EMD SERONO

75 IU/VIAL

N021322 001

Oct 08, 2004

MAFENIDE ACETATE

CREAM; TOPICAL

SULFAMYLON
XX + UDL LABS
FOR SOLUTION; TOPICAL

SULFAMYLON
XX + UDL LABS

EQ 85MG BASE/GM

N016763 001

5%

N019832 003

Jun 05, 1998

MAGNESIUM ACETATE TETRAHYDRATE; POTASSIUM ACETATE; SODIUM CHLORIDE

INJECTABLE; INJECTION PLASMA-LYTE 56 IN PLASTIC CONTAINER BAXTER HLTHCARE 32MG/100ML;128MG/100ML;234MG/100ML XX

N019047 001

Jun 15, 1984

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 267 (of 424)

MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE

INJECTABLE; INJECTION

ISOLYTE S PH 7.4 IN PLASTIC CONTAINER
30MG/100ML;37MG/100ML;0.82MG/100ML;370M XX + B BRAUN G/100ML;530MG/100ML;500MG/100ML;12MG/10 0ML

N019696 001

Sep 29, 1989

MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE
INJECTABLE; INJECTION PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER BAXTER HLTHCARE 30MG/100ML;37MG/100ML;368MG/100ML;526MG /100ML;502MG/100ML PLASMA-LYTE A IN PLASTIC CONTAINER BAXTER HLTHCARE 30MG/100ML;37MG/100ML;368MG/100ML;526MG /100ML;502MG/100ML ISOLYTE S IN PLASTIC CONTAINER B BRAUN 30MG/100ML;37MG/100ML;370MG/100ML;530MG /100ML;500MG/100ML NORMOSOL-R IN PLASTIC CONTAINER HOSPIRA 30MG/100ML;37MG/100ML;222MG/100ML;526MG /100ML;502MG/100ML

AP

N017378 001

AP

N017378 002

Nov 22, 1982

XX

N019711 001

Sep 29, 1989

XX

N017586 001

SOLUTION; IRRIGATION PHYSIOLYTE IN PLASTIC CONTAINER B BRAUN 30MG/100ML;37MG/100ML;370MG/100ML;530MG XX /100ML;500MG/100ML PHYSIOSOL IN PLASTIC CONTAINER HOSPIRA 30MG/100ML;37MG/100ML;222MG/100ML;526MG XX /100ML;502MG/100ML

N019024 001

Jun 08, 1984

N017637 002

Jul 08, 1982

MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE

SOLUTION; INJECTION

NORMOCARB HF 25
XX + DIALYSIS SUPS NORMOCARB HF 35 XX + DIALYSIS SUPS

0.21GM/100ML;2.8GM/100ML;9.07GM/100ML 0.21GM/100ML;3.97GM/100ML;8.3GM/100ML

N021910 001 N021910 002

Jul 26, 2006 Jul 26, 2006

MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE

TABLET; ORAL
MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE
SANTARUS 343MG;20MG;750MG
XX 343MG;40MG;750MG XX +

N022456 001 N022456 002

Dec 04, 2009 Dec 04, 2009

MAGNESIUM SULFATE
INJECTABLE; INJECTION MAGNESIUM SULFATE + ABRAXIS PHARM 500MG/ML HOSPIRA 500MG/ML MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER + HOSPIRA 1GM/100ML + 2GM/100ML MAGNESIUM SULFATE IN PLASTIC CONTAINER
HOSPIRA 2GM/50ML (40MG/ML)
+ 4GM/100ML (40MG/ML) + 4GM/50ML (80MG/ML)

AP AP XX XX XX XX XX

N019316 001 A075151 001 N020488 001 N020488 002 N020309 003 N020309 001 N020309 002

Sep 08, 1986 Apr 25, 2000 Jul 11, 1995 Jul 11, 1995 Jan 26, 2007 Jun 24, 1994 Jun 24, 1994

MAGNESIUM SULFATE ANHYDROUS; POTASSIUM SULFATE; SODIUM SULFATE

SOLUTION; ORAL

SUPREP BOWEL PREP KIT

XX + BRAINTREE LABS

1.6GM/BOT;3.13GM/BOT;17.5GM/BOT

N022372 001

Aug 05, 2010

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 268 (of 424)

MAGNESIUM SULFATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM PHOSPHATE
SOLUTION; IRRIGATION TIS-U-SOL BAXTER HLTHCARE AT

AT

20MG/100ML;40MG/100ML;6.25MG/100ML;800M G/100ML;8.75MG/100ML TIS-U-SOL IN PLASTIC CONTAINER BAXTER HLTHCARE 20MG/100ML;40MG/100ML;6.25MG/100ML;800M G/100ML;8.75MG/100ML

N018508 001

Feb 19, 1982

N018336 001

MALATHION
LOTION; TOPICAL MALATHION SYNERX PHARMA AT OVIDE AT + TARO PHARMS NORTH

0.5% 0.5%

A078743 001 N018613 001

Mar 06, 2009 Aug 02, 1982

MANGANESE CHLORIDE
INJECTABLE; INJECTION MANGANESE CHLORIDE IN PLASTIC CONTAINER HOSPIRA EQ 0.1MG MANGANESE/ML XX

N018962 001

Jun 26, 1986

MANNITOL
INJECTABLE; INJECTION MANNITOL 10% B BRAUN 10GM/100ML MANNITOL 10% IN PLASTIC CONTAINER B BRAUN 10GM/100ML HOSPIRA 10GM/100ML MANNITOL 10% W/ DEXTROSE 5% IN DISTILLED WATER B BRAUN 10GM/100ML MANNITOL 15% B BRAUN 15GM/100ML MANNITOL 15% IN PLASTIC CONTAINER B BRAUN 15GM/100ML HOSPIRA 15GM/100ML MANNITOL 15% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.45% B BRAUN 15GM/100ML MANNITOL 20% B BRAUN 20GM/100ML 20GM/100ML MANNITOL 20% IN PLASTIC CONTAINER B BRAUN 20GM/100ML HOSPIRA 20GM/100ML MANNITOL 25% APP PHARMS 12.5GM/50ML HOSPIRA 12.5GM/50ML INTL MEDICATION 12.5GM/50ML LUITPOLD 12.5GM/50ML MANNITOL 5% B BRAUN 5GM/100ML MANNITOL 5% IN PLASTIC CONTAINER B BRAUN 5GM/100ML HOSPIRA 5GM/100ML MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12% B BRAUN 5GM/100ML OSMITROL 10% IN WATER BAXTER HLTHCARE 10GM/100ML OSMITROL 10% IN WATER IN PLASTIC CONTAINER BAXTER HLTHCARE 10GM/100ML

AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP

N016080 002 N020006 002 N019603 002 N016080 006 N016080 003 N020006 003 N019603 003 N016080 005 N014738 001 N016080 004 N020006 004 N019603 004 A080677 N016269 A083051 A087409 001 006 001 001 Jul 26, 1993 Jan 08, 1990 Jul 26, 1993 Jan 08, 1990 Jul 26, 1993 Jan 08, 1987

Aug 25, 1994 Jan 21, 1982

N016080 001 N020006 001 N019603 001 N016080 007 N013684 002 N013684 006 Jul 26, 1993 Jan 08, 1987

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

MANNITOL
INJECTABLE; INJECTION OSMITROL 15% IN WATER BAXTER HLTHCARE 15GM/100ML OSMITROL 15% IN WATER IN PLASTIC CONTAINER BAXTER HLTHCARE 15GM/100ML OSMITROL 20% IN WATER BAXTER HLTHCARE 20GM/100ML OSMITROL 20% IN WATER IN PLASTIC CONTAINER BAXTER HLTHCARE 20GM/100ML OSMITROL 5% IN WATER BAXTER HLTHCARE 5GM/100ML OSMITROL 5% IN WATER IN PLASTIC CONTAINER BAXTER HLTHCARE 5GM/100ML

3 - 269 (of 424)

AP AP AP AP AP AP

N013684 004 N013684 008 N013684 003 N013684 007 N013684 001 N013684 005

POWDER; INHALATION
ARIDOL KIT
XX + PHARMAXIS

N/A,5MG,10MG,20MG,40MG

N022368 001

Oct 05, 2010

SOLUTION; IRRIGATION
RESECTISOL IN PLASTIC CONTAINER
B BRAUN 5GM/100ML XX

N016772 002

MANNITOL; SORBITOL
SOLUTION; IRRIGATION
SORBITOL-MANNITOL IN PLASTIC CONTAINER
XX HOSPIRA 540MG/100ML;2.7GM/100ML

N018316 001

MAPROTILINE HYDROCHLORIDE
TABLET; ORAL MAPROTILINE HYDROCHLORIDE MYLAN 25MG XX 50MG XX + 75MG XX

A072285 002 A072285 001 A072285 003

Oct 03, 1988 Oct 03, 1988 Oct 03, 1988

MARAVIROC
TABLET; ORAL SELZENTRY VIIV HLTHCARE XX XX +

150MG 300MG

N022128 001 N022128 002

Aug 06, 2007 Aug 06, 2007

MEBENDAZOLE
TABLET, CHEWABLE; ORAL
MEBENDAZOLE
XX + TEVA PHARMS

100MG

A073580 001

Jan 04, 1995

MECASERMIN RECOMBINANT
INJECTABLE; SUBCUTANEOUS
INCRELEX
XX + TERCICA

40MG/4ML (10MG/ML)

N021839 001

Aug 30, 2005

MECHLORETHAMINE HYDROCHLORIDE
INJECTABLE; INJECTION
MUSTARGEN
XX + LUNDBECK INC

10MG/VIAL

N006695 001

MECLIZINE HYDROCHLORIDE
TABLET; ORAL ANTIVERT AA + PFIZER AA +

12.5MG 25MG

N010721 006 N010721 004

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

MECLIZINE HYDROCHLORIDE
TABLET; ORAL ANTIVERT AA + PFIZER 50MG MECLIZINE HYDROCHLORIDE AMNEAL PHARMS AA 12.5MG AA 25MG AA 50MG JUBILANT CADISTA AA 12.5MG AA 25MG PAR PHARM AA 12.5MG AA 25MG AA 50MG SANDOZ AA 12.5MG AA 25MG VINTAGE PHARMS AA 12.5MG AA 25MG WATSON LABS AA 25MG

3 - 270 (of 424)

N010721 001 A201451 A201451 A201451 A040659 A040659 A087127 A087128 A089674 A084843 A084092 A040179 A040179 A085740 001 002 003 001 002 001 001 001 002 003 001 002 001

Jan 20, 1982 Feb Feb Feb Jun Jun 23, 23, 23, 04, 04, 2011 2011 2011 2010 2010

Mar May May Jan Jan

31, 22, 22, 30, 30,

1988 1989 1989 1997 1997

MECLOFENAMATE SODIUM
CAPSULE; ORAL MECLOFENAMATE SODIUM MYLAN AB AB + WATSON LABS AB AB

EQ EQ EQ EQ

50MG BASE 100MG BASE 50MG BASE 100MG BASE

A071081 A071081 A071468 A071469

002 001 001 001

Sep Sep Apr Apr

03, 03, 15, 15,

1986 1986 1987 1987

MEDROXYPROGESTERONE ACETATE
INJECTABLE; INJECTION DEPO-PROVERA + PHARMACIA AND UPJOHN 150MG/ML MEDROXYPROGESTERONE ACETATE SANDOZ 150MG/ML TEVA PARENTERAL 150MG/ML 150MG/ML DEPO-PROVERA + PHARMACIA AND UPJOHN 400MG/ML

AB AB AB AB XX

N020246 001 A078711 001 A076552 001 A076553 001 N012541 003

Oct 29, 1992 May 20, 2009 Oct 27, 2004 Jul 28, 2004

INJECTABLE; SUBCUTANEOUS

DEPO-SUBQ PROVERA 104
XX + PHARMACIA AND UPJOHN

104MG/0.65ML

N021583 001

Dec 17, 2004

TABLET; ORAL MEDROXYPROGESTERONE ACETATE BARR AB 2.5MG AB 5MG AB 10MG PROVERA PHARMACIA AND UPJOHN 2.5MG AB AB 5MG AB + 10MG MEDROXYPROGESTERONE ACETATE BP USL PHARMA 10MG

A040159 001 A040159 002 A040159 003 N011839 001 N011839 003 N011839 004 A088484 001

Aug 09, 1996 Aug 09, 1996 Aug 09, 1996

Jul 26, 1984

MEFENAMIC ACID
CAPSULE; ORAL MEFENAMIC ACID LUPIN LTD AB MICRO LABS LTD AB PONSTEL AB + SHIONOGI INC

250MG 250MG 250MG

A091322 001 A090562 001 N015034 003

Jul 22, 2011 Nov 19, 2010

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

MEFLOQUINE HYDROCHLORIDE
TABLET; ORAL MEFLOQUINE HYDROCHLORIDE BARR 250MG ROXANE 250MG + SANDOZ 250MG WEST WARD 250MG

3 - 271 (of 424)

AB AB AB AB

A076392 A076523 A076175 A077699

001 001 001 001

Dec Oct Feb Apr

29, 01, 20, 21,

2003 2004 2002 2010

MEGESTROL ACETATE
SUSPENSION; ORAL MEGACE + BRISTOL MYERS SQUIBB MEGESTROL ACETATE APOTEX INC PAR PHARM ROXANE TEVA PHARMS WOCKHARDT MEGACE ES + PAR PHARM

AB AB AB AB AB AB XX

40MG/ML 40MG/ML 40MG/ML 40MG/ML 40MG/ML 40MG/ML 125MG/ML

N020264 001 A077404 A075671 A075997 A075681 A076721 001 001 001 001 001

Sep 10, 1993 Feb Jul Feb May Nov 16, 25, 15, 05, 01, 2006 2001 2002 2003 2004

N021778 001

Jul 05, 2005

TABLET; ORAL MEGESTROL ACETATE BARR AB AB PAR PHARM AB AB + ROXANE AB AB

20MG 40MG 20MG 40MG 20MG 40MG

A074621 A074621 A072422 A072423 A074458 A074458

002 001 001 001 001 002

Aug Nov Aug Aug Sep Sep

16, 30, 08, 08, 29, 29,

1996 1995 1988 1988 1995 1995

MELOXICAM
SUSPENSION; ORAL

MOBIC

XX + BOEHRINGER INGELHEIM TABLET; ORAL MELOXICAM APOTEX INC AB AB AUROBINDO PHARMA AB AB BEIJING DOUBLE CRANE AB AB BRECKENRIDGE PHARM AB AB CARACO AB AB CARLSBAD AB AB COREPHARMA AB AB DR REDDYS LABS INC AB AB GLENMARK GENERICS AB AB LUPIN PHARMS AB AB MYLAN AB AB AB AB PURACAP PHARM AB

7.5MG/5ML

N021530 001

Jun 01, 2004

7.5MG 15MG 7.5MG 15MG 7.5MG 15MG 7.5MG 15MG 7.5MG 15MG 7.5MG 15MG 7.5MG 15MG 7.5MG 15MG 7.5MG 15MG 7.5MG 15MG 7.5MG 7.5MG 15MG 15MG 7.5MG

A077882 A077882 A078008 A078008 A078039 A078039 A077920 A077920 A077937 A077937 A077918 A077918 A077930 A077930 A077931 A077931 A077932 A077932 A077944 A077944 A077923 A077934 A077923 A077934 A077938

001 002 001 002 001 002 001 002 001 002 001 002 001 002 001 002 001 002 001 002 001 001 002 002 001

Jul Jul Oct Oct Dec Dec Jul Jul Jul Jul Dec Dec Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul

20, 20, 02, 02, 14, 14, 19, 19, 19, 19, 07, 07, 19, 19, 25, 25, 19, 19, 19, 19, 19, 20, 19, 20, 19,

2006 2006 2006 2006 2006 2006 2006 2006 2006 2006 2006 2006 2006 2006 2006 2006 2006 2006 2006 2006 2006 2006 2006 2006 2006

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

MELOXICAM
TABLET; ORAL MELOXICAM PURACAP PHARM AB STRIDES ARCOLAB LTD AB AB TARO AB AB TEVA PHARMS AB AB UNICHEM AB AB WATSON LABS AB AB ZYDUS PHARMS USA AB AB MOBIC BOEHRINGER INGELHEIM AB AB +

3 - 272 (of 424)

15MG 7.5MG 15MG 7.5MG 15MG 7.5MG 15MG 7.5MG 15MG 7.5MG 15MG 7.5MG 15MG 7.5MG 15MG

A077938 A077928 A077928 A078102 A078102 A077936 A077936 A077927 A077927 A077929 A077929 A077921 A077921

002 001 002 001 002 001 002 001 002 001 002 001 002

Jul May May Nov Nov Jul Jul Dec Dec Jul Jul Jul Jul

19, 13, 13, 07, 07, 19, 19, 20, 20, 19, 19, 19, 19,

2006 2009 2009 2006 2006 2006 2006 2006 2006 2006 2006 2006 2006

N020938 001 N020938 002

Apr 13, 2000 Aug 23, 2000

MELPHALAN
TABLET; ORAL

ALKERAN

XX + GLAXOSMITHKLINE

2MG

N014691 002

MELPHALAN HYDROCHLORIDE
INJECTABLE; INJECTION ALKERAN + GLAXOSMITHKLINE MELPHALAN HYDROCHLORIDE BEDFORD LABS BIONICHE PHARMA USA SYNERX

AP AP AP AP

EQ 50MG BASE/VIAL EQ 50MG BASE/VIAL EQ 50MG BASE/VIAL EQ 50MG BASE/VIAL

N020207 001 A090303 001 A090299 001 A090270 001

Nov 18, 1992 Oct 28, 2010 Oct 27, 2009 Jun 09, 2009

MEMANTINE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL NAMENDA XR FOREST LABS 7MG XX 14MG XX 21MG XX 28MG XX + SOLUTION; ORAL

NAMENDA

XX + FOREST LABS TABLET; ORAL NAMENDA XX FOREST LABS XX +

N022525 N022525 N022525 N022525

001 002 003 004

Jun Jun Jun Jun

21, 21, 21, 21,

2010 2010 2010 2010

2MG/ML

N021627 001

Apr 18, 2005

5MG 10MG

N021487 001 N021487 002

Oct 16, 2003 Oct 16, 2003

MENOTROPINS (FSH;LH)

INJECTABLE; IM-SC

REPRONEX
XX + FERRING
INJECTABLE; SUBCUTANEOUS

MENOPUR
XX + FERRING

75 IU/VIAL;75 IU/VIAL

N021047 001

Aug 27, 1999

75 IU/VIAL;75 IU/VIAL

N021663 001

Oct 29, 2004

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

MEPENZOLATE BROMIDE
TABLET; ORAL
CANTIL
XX + SANOFI AVENTIS US

3 - 273 (of 424)

25MG

N010679 003

MEPERIDINE HYDROCHLORIDE
INJECTABLE; INJECTION DEMEROL + HOSPIRA 25MG/ML + 50MG/ML + 75MG/ML + 100MG/ML MEPERIDINE HYDROCHLORIDE BAXTER HLTHCARE CORP 25MG/ML 50MG/ML 75MG/ML 100MG/ML ELKINS SINN 25MG/ML 50MG/ML 75MG/ML 100MG/ML WATSON LABS 50MG/ML 100MG/ML MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE BAXTER HLTHCARE CORP 10MG/ML + HOSPIRA 10MG/ML INTL MEDICATION 10MG/ML WATSON LABS 10MG/ML

AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP

N021171 N021171 N021171 N021171 A080455 A080455 A080455 A080455 A080445 A080445 A080445 A080445 A073444 A073445 A081002 A088432 A081309 A073443

001 002 003 004 007 008 009 010 001 002 003 004 001 001 001 001 001 001

Mar 17, 1992 Mar 17, 1992 Jul Aug Aug Mar 30, 16, 30, 17, 1993 1984 1993 1992

SYRUP; ORAL
MEPERIDINE HYDROCHLORIDE
50MG/5ML XX + ROXANE TABLET; ORAL DEMEROL + SANOFI AVENTIS US 50MG + 100MG MEPERIDINE HYDROCHLORIDE BARR 50MG 100MG CARACO 50MG 100MG EPIC PHARMA 50MG 100MG MALLINCKRODT 50MG 100MG MIKART 50MG 100MG ROXANE 50MG 100MG VINTAGE PHARMS 50MG 100MG WATSON LABS 50MG 100MG MEPERIDINE HYDROCHLORIDE MIKART 75MG 150MG

A088744 001

Jan 30, 1985

AA AA AA AA AA AA AA AA AA AA AA AA AA AA AA AA AA AA XX XX

N005010 001 N005010 004 A088639 A088640 A040446 A040446 A040331 A040331 A040352 A040352 A040893 A040893 A040110 A040110 A040191 A040191 A040186 A040186 001 001 001 002 001 002 001 002 001 003 001 002 001 002 001 002 Jul Sep Aug Aug May May Jun Jun Jun Jun Mar Mar Dec Dec Jun Jun 02, 19, 08, 08, 28, 28, 13, 13, 24, 24, 12, 12, 17, 17, 30, 30, 1984 1984 2002 2002 1999 1999 2000 2000 2009 2009 1997 1997 1998 1998 1997 1997

A040893 002 A040893 004

Jun 24, 2009 Jun 24, 2009

MEPIVACAINE HYDROCHLORIDE
INJECTABLE; INJECTION CARBOCAINE AP + HOSPIRA

1%

N012250 001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

MEPIVACAINE HYDROCHLORIDE
INJECTABLE; INJECTION CARBOCAINE + HOSPIRA 1.5% + 2% ISOCAINE HYDROCHLORIDE + NOVOCOL 3% MEPIVACAINE HYDROCHLORIDE HOSPIRA INC 3% WATSON LABS 1% 2% POLOCAINE APP PHARMS 1% 2% DENTSPLY PHARM 3% POLOCAINE-MPF APP PHARMS 1% 1.5% 2% SCANDONEST PLAIN + DEPROCO 3%

3 - 274 (of 424)

AP AP AP AP AP AP AP AP AP AP AP AP AP

N012250 005 N012250 002 A080925 001 A040806 001 A088769 001 A088770 001 A089407 001 A089410 001 A088653 001 A089406 001 A089408 001 A089409 001 A088387 001 Apr 28, 2008 Nov 20, 1984 Nov 20, 1984 Dec 01, 1986 Dec 01, 1986 Aug 21, 1984 Dec 01, 1986 Dec 01, 1986 Dec 01, 1986 Oct 10, 1984

MEPROBAMATE
TABLET; ORAL MEPROBAMATE ALEMBIC PHARMS LTD AA AA INVAGEN PHARMS AA AA TARO AA AA AA + WATSON LABS AA +

200MG 400MG 200MG 400MG 200MG 400MG 200MG 400MG

A090122 A090122 A040797 A040797 A200998 A200998 A083304 A083308

001 002 001 002 001 002 001 001

Feb Feb Feb Feb May May

18, 18, 27, 27, 23, 23,

2009 2009 2008 2008 2011 2011

MEQUINOL; TRETINOIN
SOLUTION; TOPICAL
SOLAGE
XX + AQUA PHARMS

2%;0.01%

N020922 001

Dec 10, 1999

MERCAPTOPURINE
TABLET; ORAL MERCAPTOPURINE MYLAN PROMETHEUS LABS ROXANE PURINETHOL + TEVA

AB AB AB AB

50MG 50MG 50MG 50MG

A040594 001 A040461 001 A040528 001 N009053 002

Jul 01, 2005 Feb 11, 2004 Feb 13, 2004

MEROPENEM
INJECTABLE; INJECTION MEROPENEM ACS DOBFAR AP AP HOSPIRA INC AP AP SANDOZ AP AP MERREM AP + ASTRAZENECA AP +

500MG/VIAL 1GM/VIAL 500MG/VIAL 1GM/VIAL 500MG/VIAL 1GM/VIAL 500MG/VIAL 1GM/VIAL

A091404 A091404 A090940 A090940 A091201 A091201

001 002 001 002 001 002

Oct Oct Jun Jun Mar Mar

26, 26, 22, 22, 29, 29,

2011 2011 2010 2010 2011 2011

N050706 003 N050706 001

Jun 21, 1996 Jun 21, 1996

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

MESALAMINE
CAPSULE, EXTENDED RELEASE; ORAL

APRISO

375MG XX + SALIX PHARMS PENTASA SHIRE 250MG XX 500MG XX + ENEMA; RECTAL MESALAMINE PERRIGO ISRAEL TEVA ROWASA + MEDA PHARMS SFROWASA MEDA PHARMS

3 - 275 (of 424)

N022301 001 N020049 001 N020049 002

Oct 31, 2008 May 10, 1993 Jul 08, 2004

AB AB AB AB

4GM/60ML 4GM/60ML 4GM/60ML 4GM/60ML

A076751 001 A076841 001 N019618 001 N019618 002

Sep 17, 2004 Sep 30, 2004 Dec 24, 1987 Jun 20, 2008

SUPPOSITORY; RECTAL

CANASA

XX + AXCAN

1GM

N021252 002

Nov 05, 2004

TABLET, DELAYED RELEASE; ORAL

ASACOL

400MG XX + WARNER CHILCOTT LLC ASACOL HD 800MG XX + WARNER CHILCOTT LLC LIALDA 1.2GM XX + SHIRE

N019651 001 N021830 001 N022000 001

Jan 31, 1992 May 29, 2008 Jan 16, 2007

MESNA
INJECTABLE; INTRAVENOUS MESNA APP PHARMS BEDFORD SAGENT STRIDES TEVA PARENTERAL MESNEX + BAXTER HLTHCARE

AP AP AP AP AP

100MG/ML 100MG/ML 100MG/ML 100MG/ML 100MG/ML

A075811 A075739 A090913 A075764

001 001 001 001

Apr Jan Apr Apr

26, 09, 13, 27,

2001 2004 2010 2001

N019884 001

Dec 30, 1988

TABLET; ORAL

MESNEX

XX + BAXTER HLTHCARE

400MG

N020855 001

Mar 21, 2002

MESTRANOL; NORETHINDRONE

TABLET; ORAL-28

NORINYL 1+50 28-DAY
XX + WATSON LABS

0.05MG;1MG

N016659 001

METAPROTERENOL SULFATE
SOLUTION; INHALATION METAPROTERENOL SULFATE AN + DEY AN + NOVEX AN AN WOCKHARDT AN AN SYRUP; ORAL METAPROTERENOL SULFATE NOVEX AA AA + SILARX

0.4% 0.6% 0.4% 0.6% 0.4% 0.6%

A071786 A070804 A075402 A075403 A075586 A075586

001 001 001 001 001 002

Aug Aug Feb Feb May May

05, 17, 28, 28, 30, 30,

1988 1987 2001 2001 2002 2002

10MG/5ML 10MG/5ML

A075235 001 A073632 001

Jan 27, 2000 Jul 22, 1992

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

METAPROTERENOL SULFATE
TABLET; ORAL METAPROTERENOL SULFATE PAR PHARM AB AB + WATSON LABS AB AB

3 - 276 (of 424)

10MG 20MG 10MG 20MG

A072024 A072025 A073013 A072795

001 001 001 001

Jun Jun Jan Jan

28, 28, 31, 31,

1988 1988 1991 1991

METARAMINOL BITARTRATE
INJECTABLE; INJECTION
METARAMINOL BITARTRATE
EQ 10MG BASE/ML XX + APP PHARMS

A080722 001

METAXALONE
TABLET; ORAL METAXALONE SANDOZ AB SKELAXIN AB + KING PHARMS

800MG 800MG

A040445 001 N013217 003

Mar 31, 2010 Aug 30, 2002

METFORMIN HYDROCHLORIDE
SOLUTION; ORAL
RIOMET
XX + RANBAXY TABLET; ORAL GLUCOPHAGE BRISTOL MYERS SQUIBB AB AB AB + METFORMIN HYDROCHLORIDE ALKEM AB AB AB ALPHAPHARM AB AB AB ALVOGEN AB AB AB AMNEAL PHARMS NY AB AB AB APOTEX AB AB AB AB AB AB AUROBINDO AB AB AB CARACO AB AB AB DR REDDYS LABS INC AB AB AB GLENMARK GENERICS AB AB AB

500MG/5ML

N021591 001

Sep 11, 2003

500MG 850MG 1GM 500MG 850MG 1GM 500MG 850MG 1GM 500MG 850MG 1GM 500MG 850MG 1GM 500MG 500MG 850MG 850MG 1GM 1GM 500MG 850MG 1GM 500MG 850MG 1GM 500MG 850MG 1GM 500MG 850MG 1GM

N020357 001 N020357 002 N020357 005 A091184 A091184 A091184 A075969 A075969 A075969 A076033 A076033 A076033 A077880 A077880 A077880 A075984 A090666 A075984 A090666 A075984 A090666 A077095 A077095 A077095 A075967 A075967 A075967 A077787 A077787 A077787 A078170 A078170 A078170 001 002 003 001 002 003 001 002 003 001 002 003 001 001 002 002 003 003 001 002 003 001 002 003 001 002 003 001 002 003

Mar 03, 1995 Mar 03, 1995 Nov 05, 1998 Nov Nov Nov Jan Jan Jan Jan Jan Jan Jun Jun Jun Apr Dec Apr Dec Apr Dec Jan Jan Jan Jan Jan Jan Aug Aug Aug May May May 01, 01, 01, 29, 29, 29, 24, 24, 24, 05, 05, 05, 23, 07, 23, 07, 23, 07, 14, 14, 14, 29, 29, 29, 23, 23, 23, 23, 23, 23, 2010 2010 2010 2002 2002 2002 2002 2002 2002 2006 2006 2006 2002 2011 2002 2011 2002 2011 2005 2005 2005 2002 2002 2002 2006 2006 2006 2008 2008 2008

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

METFORMIN HYDROCHLORIDE
TABLET; ORAL METFORMIN HYDROCHLORIDE GRANULES INDIA AB 500MG AB 850MG AB 1GM INDICUS PHARMA AB 500MG AB 850MG AB 1GM IVAX SUB TEVA PHARMS 500MG AB AB 850MG AB 1GM MUTUAL PHARMA AB 500MG AB 850MG AB 1GM MYLAN AB 500MG AB 500MG AB 850MG AB 850MG AB 1GM AB 1GM PROVIDENT PHARM AB 500MG AB 850MG AB 1GM SANDOZ AB 500MG AB 500MG AB 850MG AB 850MG AB 1GM AB 1GM TEVA AB 500MG AB 850MG AB 1GM TORRENT PHARMS AB 500MG AB 850MG AB 1GM WATSON LABS AB 500MG AB 850MG AB 1GM WATSON LABS FLORIDA AB 500MG AB 850MG AB 1GM ZYDUS PHARMS USA AB 500MG AB 850MG AB 1GM METFORMIN HYDROCHLORIDE IVAX SUB TEVA PHARMS 625MG XX 750MG XX TABLET, EXTENDED RELEASE; FORTAMET + ANDRX LABS LLC GLUCOPHAGE XR + BRISTOL MYERS SQUIBB METFORMIN HYDROCHLORIDE ALVOGEN AMNEAL PHARMS NY APOTEX BARR IMPAX LABS LUPIN LTD ORAL 1GM 750MG 750MG 750MG 750MG 750MG 750MG 1GM

3 - 277 (of 424)

A090564 A090564 A090564 A079148 A079148 A079148 A075972 A075972 A075972 A076038 A076038 A076038 A075973 A075976 A075973 A075976 A075973 A075976 A077853 A077853 A077853 A075965 A075985 A075965 A075985 A075965 A075985 A075978 A075978 A075978 A077711 A077711 A077711 A075979 A075979 A075979 A075961 A075961 A075961 A077064 A077064 A077064

001 002 003 001 002 003 001 002 003 001 002 003 001 001 002 002 003 003 001 002 003 001 001 002 002 003 003 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003

Apr Apr Apr Nov Nov Nov Jan Jan Jan Feb Feb Feb Jan Jan Jan Jan Jan Jan Jul Jul Jul Jan Jan Jan Jan Jan Jan Jan Jan Nov Jan Jan Jan Jan Jan Jan Jan Jan Jan Apr Apr Apr

22, 22, 22, 25, 25, 25, 24, 24, 24, 21, 21, 21, 25, 24, 25, 24, 25, 24, 28, 28, 28, 25, 25, 25, 25, 25, 25, 25, 25, 05, 24, 24, 24, 24, 24, 24, 25, 25, 25, 18, 18, 18,

2010 2010 2010 2008 2008 2008 2002 2002 2002 2002 2002 2002 2002 2002 2002 2002 2002 2002 2006 2006 2006 2002 2002 2002 2002 2002 2002 2002 2002 2002 2007 2007 2007 2002 2002 2002 2002 2002 2002 2005 2005 2005

A075972 005 A075972 004

Jan 24, 2002 Jan 24, 2002

AB AB AB AB AB AB AB AB

N021574 002 N021202 004 A078321 A078596 A076706 A076863 A076985 A090692 002 002 002 001 001 002

Apr 27, 2004 Apr 11, 2003 Apr Jan Dec Oct Sep Jun 17, 03, 29, 14, 13, 29, 2008 2008 2005 2004 2005 2011

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

METFORMIN HYDROCHLORIDE
TABLET, EXTENDED RELEASE; METFORMIN HYDROCHLORIDE MYLAN AB RANBAXY AB SUN PHARM INDS (IN) AB TEVA AB TORRENT PHARMS AB WATSON LABS FLORIDA AB ZYDUS PHARMS USA AB GLUCOPHAGE XR BRISTOL MYERS SQUIBB AB1 METFORMIN HYDROCHLORIDE ALVOGEN AB1 AMNEAL PHARMS NY AB1 APOTEX AB1 IMPAX LABS AB1 MYLAN AB1 NOSTRUM AB1 RANBAXY LABS LTD AB1 SANDOZ AB1 SUN PHARM INDS (IN) AB1 TEVA AB1 TORRENT PHARM AB1 WATSON LABS FLORIDA AB1 WATSON LABS INC AB1 ZYDUS PHARMS USA AB1 FORTAMET ANDRX LABS LLC AB2 METFORMIN HYDROCHLORIDE LUPIN LTD AB2 GLUMETZA BX SANTARUS BX + ORAL 750MG 750MG 750MG 750MG 750MG 750MG 750MG 500MG 500MG 500MG 500MG 500MG 500MG 500MG 500MG 500MG 500MG 500MG 500MG 500MG 500MG 500MG 500MG 500MG 500MG 1GM A077113 A077211 A077336 A076864 A079226 A076869 A077078

3 - 278 (of 424)

001 001 002 001 001 001 001

Sep Jun Feb Apr Feb Apr Apr

08, 29, 09, 12, 18, 12, 21,

2005 2005 2006 2005 2010 2005 2005

N021202 001 A078321 A078596 A076706 A076249 A076650 A076756 A076413 A076873 A077336 A076269 A090014 A076172 A076818 A077060 001 001 001 001 001 001 001 001 001 001 001 001 001 001

Oct 13, 2000 Apr Jan Dec Jul Sep Jul Jun Dec Feb Jun Dec Jun Dec Apr 17, 03, 14, 30, 13, 26, 18, 14, 09, 18, 30, 16, 14, 20, 2008 2008 2004 2004 2005 2006 2004 2004 2006 2004 2009 2004 2004 2005

N021574 001 A090692 001 N021748 001 N021748 002

Apr 27, 2004 Jun 29, 2011 Jun 03, 2005 Jun 03, 2005

METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE

TABLET; ORAL ACTOPLUS MET TAKEDA GLOBAL 500MG;EQ 15MG BASE + 850MG;EQ 15MG BASE PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE MYLAN 500MG;EQ 15MG BASE 850MG;EQ 15MG BASE

AB AB AB AB

N021842 001 N021842 002 A090406 001 A090406 002

Aug 29, 2005 Aug 29, 2005 Feb 25, 2011 Feb 25, 2011

TABLET, EXTENDED RELEASE; ORAL ACTOPLUS MET XR TAKEDA GLOBAL 1GM;EQ 15MG BASE XX 1GM;EQ 30MG BASE XX +

N022024 001 N022024 002

May 12, 2009 May 12, 2009

METFORMIN HYDROCHLORIDE; REPAGLINIDE

TABLET; ORAL PRANDIMET NOVO NORDISK INC XX XX +

500MG;1MG 500MG;2MG

N022386 001 N022386 002

Jun 23, 2008 Jun 23, 2008

METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE

TABLET; ORAL AVANDAMET SB PHARMCO XX XX XX

500MG;EQ 2MG BASE 500MG;EQ 4MG BASE 1GM;EQ 2MG BASE

N021410 002 N021410 003 N021410 004

Oct 10, 2002 Oct 10, 2002 Aug 25, 2003

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE
TABLET; ORAL
AVANDAMET
XX + SB PHARMCO

3 - 279 (of 424)

1GM;EQ 4MG BASE

N021410 005

Aug 25, 2003

METFORMIN HYDROCHLORIDE; SAXAGLIPTIN

TABLET, EXTENDED RELEASE; ORAL KOMBIGLYZE XR BRISTOL MYERS SQUIBB 500MG;5MG XX 1GM;2.5MG XX 1GM;5MG XX +

N200678 001 N200678 003 N200678 002

Nov 05, 2010 Nov 05, 2010 Nov 05, 2010

METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE

TABLET; ORAL JANUMET MERCK XX XX +

500MG;EQ 50MG BASE 1GM;EQ 50MG BASE

N022044 001 N022044 002

Mar 30, 2007 Mar 30, 2007

METHACHOLINE CHLORIDE
FOR SOLUTION; INHALATION
PROVOCHOLINE
XX + METHAPHARM

100MG/VIAL

N019193 001

Oct 31, 1986

METHADONE HYDROCHLORIDE
CONCENTRATE; ORAL METHADONE HYDROCHLORIDE ROXANE VISTAPHARM METHADONE HYDROCHLORIDE ROXANE METHADOSE + MALLINCKRODT

AA AA AA AA

10MG/ML 10MG/ML INTENSOL 10MG/ML 10MG/ML

A040180 001 A040088 001 A089897 001 N017116 002

Apr 30, 1998 Nov 30, 1994 Sep 06, 1988

INJECTABLE; INJECTION
DOLOPHINE HYDROCHLORIDE
10MG/ML XX + MYLAN INSTITUTIONAL POWDER; FOR RX COMPOUNDING
METHADONE HYDROCHLORIDE
MALLINCKRODT 50GM/BOT XX 100GM/BOT XX 500GM/BOT XX SOLUTION; ORAL METHADONE HYDROCHLORIDE AA + ROXANE 5MG/5ML AA + 10MG/5ML VISTAPHARM AA 5MG/5ML AA 10MG/5ML TABLET; ORAL DOLOPHINE HYDROCHLORIDE AA + ROXANE 5MG AA + 10MG METHADONE HYDROCHLORIDE MALLINCKRODT AA 5MG AA 10MG AA 40MG AA + ROXANE 40MG SANDOZ AA 10MG AA 40MG THE PHARMANETWORK AA 10MG

N021624 001

N006383 002
N006383 003
N006383 004

A087393 A087997 A090707 A090707

001 001 001 002

Aug 30, 1982 Jun 30, 2010 Jun 30, 2010

N006134 002 N006134 010 A040517 A040517 A077142 N017058 A040241 A075082 A090635 001 002 001 001 002 001 001 Apr 27, 2004 Apr 27, 2004 Jul 12, 2005 May 29, 1998 Mar 25, 1998 Nov 25, 2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

METHADONE HYDROCHLORIDE
TABLET; ORAL METHADOSE MALLINCKRODT AA AA AA

3 - 280 (of 424)

5MG 10MG 40MG

A040050 001 A040050 002 A074184 001

Apr 15, 1993 Apr 15, 1993 Apr 29, 1993

METHAMPHETAMINE HYDROCHLORIDE
TABLET; ORAL DESOXYN AA + LUNDBECK INC 5MG METHAMPHETAMINE HYDROCHLORIDE COASTAL PHARMS AA 5MG

N005378 002 A091189 001 Apr 21, 2010

METHAZOLAMIDE
TABLET; ORAL METHAZOLAMIDE MIKART AB AB + SANDOZ AB AB TEVA PHARMS AB AB

25MG 50MG 25MG 50MG 25MG 50MG

A040062 A040062 A040036 A040036 A040001 A040001

001 002 001 002 001 002

Jan Jan Jun Jun Jun Jun

27, 27, 30, 30, 30, 30,

1994 1994 1993 1993 1993 1993

METHENAMINE HIPPURATE
TABLET; ORAL HIPREX AB + SANOFI AVENTIS US METHENAMINE HIPPURATE COREPHARMA AB UREX CNTY LINE PHARMS AB

1GM 1GM 1GM

N017681 001 A076411 001 N016151 001 Jun 20, 2003

METHIMAZOLE
TABLET; ORAL METHIMAZOLE CARACO AB AB CEDAR PHARMS AB AB EMCURE PHARMS USA AB AB MYLAN AB AB + SANDOZ AB AB TAPAZOLE KING PHARMS AB AB

5MG 10MG 5MG 10MG 5MG 10MG 5MG 10MG 5MG 10MG 5MG 10MG

A040870 A040870 A040547 A040547 A040734 A040734 A040350 A040350 A040411 A040411

001 002 001 002 001 002 001 002 001 002

Sep Sep Feb Feb Dec Dec Mar Mar Mar Mar

25, 25, 18, 18, 14, 14, 29, 29, 27, 27,

2007 2007 2005 2005 2007 2007 2000 2000 2001 2001

A040320 001 A040320 002

Mar 31, 2000 Mar 31, 2000

METHOCARBAMOL
INJECTABLE; INJECTION METHOCARBAMOL WATSON LABS AP ROBAXIN AP + BAXTER HLTHCARE CORP TABLET; ORAL METHOCARBAMOL AUSTARPHARMA LLC AA

100MG/ML 100MG/ML

A086459 001 N011790 001

500MG

A200958 001

Oct 21, 2011

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

METHOCARBAMOL
TABLET; ORAL METHOCARBAMOL AUSTARPHARMA LLC AA HETERO DRUGS AA AA LANNETT HOLDINGS INC AA AA SANDOZ AA AA VINTAGE PHARMS AA AA WATSON LABS AA AA AA AA WEST WARD AA AA ROBAXIN AA + SCHWARZ PHARMA ROBAXIN-750 AA + SCHWARZ PHARMA

3 - 281 (of 424)

750MG 500MG 750MG 500MG 750MG 500MG 750MG 500MG 750MG 500MG 500MG 750MG 750MG 500MG 750MG 500MG 750MG

A200958 A090200 A090200 A084756 A084756 A084616 A084615 A040489 A040489 A084277 A085180 A084276 A085192 A085159 A085123

002 001 002 002 001 001 001 001 002 001 001 002 001 001 001

Oct Nov Nov Mar

21, 06, 06, 31,

2011 2009 2009 2003

Jan 29, 2003 Jan 29, 2003

N011011 004 N011011 006

METHOHEXITAL SODIUM
INJECTABLE; INJECTION

BREVITAL SODIUM

XX + JHP PHARMS XX +

500MG/VIAL 2.5GM/VIAL

N011559 001 N011559 002

METHOTREXATE SODIUM
INJECTABLE; INJECTION METHOTREXATE SODIUM + APP PHARMS EQ 50MG BASE/2ML (EQ 25MG BASE/ML) + EQ 250MG BASE/10ML (EQ 25MG BASE/ML) + HOSPIRA EQ 50MG BASE/2ML (EQ 25MG BASE/ML) METHOTREXATE SODIUM PRESERVATIVE FREE + BEDFORD EQ 50MG BASE/2ML (EQ 25MG BASE/ML) + EQ 250MG BASE/10ML (EQ 25MG BASE/ML) + BIONICHE PHARMA EQ 50MG BASE/2ML (EQ 25MG BASE/ML) + BIONICHE PHARMA USA EQ 250MG BASE/10ML (EQ 25MG BASE/ML) + EQ 1GM BASE/40ML (EQ 25MG BASE/ML) EBEWE PHARMA EQ 50MG BASE/2ML (EQ 25MG BASE/ML) EQ 250MG BASE/10ML (EQ 25MG BASE/ML) EQ 1GM BASE/40ML (EQ 25MG BASE/ML) + HOSPIRA EQ 1GM BASE/40ML (EQ 25MG BASE/ML) PHARMACHEMIE BV EQ 50MG BASE/2ML (EQ 25MG BASE/ML) EQ 250MG/10ML (EQ 25MG BASE/ML) EQ 1GM BASE/40ML (EQ 25MG BASE/ML) METHOTREXATE SODIUM + BEDFORD EQ 100MG BASE/4ML (EQ 25MG BASE/ML) + EQ 200MG BASE/8ML (EQ 25MG BASE/ML) METHOTREXATE SODIUM PRESERVATIVE FREE + BEDFORD EQ 1GM BASE/VIAL TABLET; ORAL METHOTREXATE SODIUM BARR + DAVA PHARMS INC MYLAN ROXANE

AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP XX XX XX

A040263 001 A040263 002 N011719 010 A089340 A089343 A040767 A040768 A040716 A090039 A090039 A090029 N011719 A040850 A040853 A040843 001 001 001 001 001 001 002 001 012 001 001 001

Feb 26, 1999 Feb 26, 1999 Dec 15, 2004 Sep Sep Apr Apr Apr Mar Mar Mar Apr Jan Jan Jan 16, 16, 30, 30, 30, 31, 31, 31, 13, 11, 11, 11, 1986 1986 2007 2007 2007 2009 2009 2009 2005 2010 2010 2010

A089341 001 A089342 001 A040632 001

Sep 16, 1986 Sep 16, 1986 Aug 12, 2005

AB AB AB AB

EQ EQ EQ EQ

2.5MG 2.5MG 2.5MG 2.5MG

BASE BASE BASE BASE

A081099 N008085 A081235 A040054

001 002 001 001

Oct 15, 1990 May 15, 1992 Aug 01, 1994

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

METHOTREXATE SODIUM
TABLET; ORAL TREXALL BARR XX XX XX XX +

3 - 282 (of 424)

EQ EQ EQ EQ

5MG BASE 7.5MG BASE 10MG BASE 15MG BASE

A040385 A040385 A040385 A040385

001 002 003 004

Mar Mar Mar Mar

21, 21, 21, 21,

2001 2001 2001 2001

METHOXSALEN
CAPSULE; ORAL

8-MOP

XX + VALEANT PHARM INTL OXSORALEN-ULTRA

XX + VALEANT PHARM INTL INJECTABLE; INJECTION

UVADEX

XX + THERAKOS LOTION; TOPICAL

OXSORALEN

XX + VALEANT PHARM INTL

10MG 10MG

N009048 001

N019600 001 Oct 30, 1986

0.02MG/ML

N020969 001

Feb 25, 1999

1%

N009048 002

METHSCOPOLAMINE BROMIDE
TABLET; ORAL METHSCOPOLAMINE BROMIDE BOCA PHARMA AA 2.5MG AA 5MG BRECKENRIDGE PHARM AA 2.5MG AA 5MG PAMINE AA + FOUGERA PHARMS 2.5MG PAMINE FORTE AA + FOUGERA PHARMS 5MG

A040624 A040624 A040642 A040642

001 002 001 002

Dec Dec Dec Dec

28, 28, 06, 06,

2006 2006 2011 2011

N008848 001 N008848 002 Mar 25, 2003

METHSUXIMIDE
CAPSULE; ORAL

CELONTIN

PARKE DAVIS XX XX +

150MG 300MG

N010596 007

N010596 008

METHYCLOTHIAZIDE
TABLET; ORAL ENDURON + ABBOTT METHYCLOTHIAZIDE MYLAN WATSON LABS ENDURON

ABBOTT

AB AB AB XX

5MG 5MG 5MG 2.5MG

N012524 004 A087672 001 A088724 001 N012524 001

Aug 17, 1982 Sep 06, 1984

METHYL AMINOLEVULINATE HYDROCHLORIDE

CREAM; TOPICAL

METVIXIA

XX + GALDERMA LABS LP

EQ 16.8% BASE

N021415 001

Jul 27, 2004

METHYLDOPA
TABLET; ORAL METHYLDOPA ACCORD HLTH AB AB

250MG 500MG

A070084 001 A070085 001

Oct 15, 1985 Oct 15, 1985

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

METHYLDOPA
TABLET; ORAL METHYLDOPA IVAX SUB TEVA PHARMS AB AB MYLAN AB AB + WATSON LABS AB

3 - 283 (of 424)

250MG 500MG 250MG 500MG 500MG

A070098 A070343 A070075 A070076 A070625

001 001 001 001 001

Feb Feb Apr Apr Jun

20, 20, 18, 18, 06,

1986 1986 1985 1985 1986

METHYLDOPATE HYDROCHLORIDE
INJECTABLE; INJECTION METHYLDOPATE HYDROCHLORIDE AP + LUITPOLD 50MG/ML TEVA PARENTERAL AP 50MG/ML

A071279 001 A072974 001

Oct 02, 1987 Nov 22, 1991

METHYLERGONOVINE MALEATE
INJECTABLE; INJECTION METHERGINE AP + NOVARTIS 0.2MG/ML METHYLERGONOVINE MALEATE ERGOJECT AP 0.2MG/ML LUITPOLD AP 0.2MG/ML TABLET; ORAL METHERGINE AB + NOVARTIS 0.2MG METHYLERGONOVINE MALEATE NOVEL LABS INC AB 0.2MG

N006035 004 A040889 001 A090193 001 Sep 13, 2010 Nov 24, 2008

N006035 003 A091577 001 May 02, 2011

METHYLNALTREXONE BROMIDE
INJECTABLE; SUBCUTANEOUS RELISTOR XX PROGENICS SOLUTION; SUBCUTANEOUS
RELISTOR
XX + PROGENICS

8MG/0.4ML

N021964 002

Sep 27, 2010

12MG/0.6ML (12MG/0.6ML)

N021964 001

Apr 24, 2008

METHYLPHENIDATE
FILM, EXTENDED RELEASE; TRANSDERMAL DAYTRANA XX NOVEN PHARMS INC 10MG/9HR (1.1MG/HR) XX 15MG/9HR (1.6MG/HR) XX 20MG/9HR (2.2MG/HR) XX + 30MG/9HR (3.3MG/HR)

N021514 N021514 N021514 N021514

001 002 003 004

Apr Apr Apr Apr

06, 06, 06, 06,

2006 2006 2006 2006

METHYLPHENIDATE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL METHYLPHENIDATE HYDROCHLORIDE ACTAVIS AB 20MG AB 30MG AB 40MG RITALIN LA NOVARTIS AB 20MG AB 30MG AB + 40MG METADATE CD BX UCB INC 10MG BX 20MG BX 30MG BX 40MG

A078458 001 A078458 002 A078458 003 N021284 001 N021284 002 N021284 003 N021259 N021259 N021259 N021259 003 001 002 004

Dec 01, 2011 Dec 01, 2011 Dec 01, 2011 Jun 05, 2002 Jun 05, 2002 Jun 05, 2002 May Apr Jun Feb 27, 03, 19, 19, 2003 2001 2003 2006

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

METHYLPHENIDATE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL RITALIN LA BX NOVARTIS 10MG METADATE CD UCB INC 50MG XX 60MG XX + SOLUTION; ORAL METHYLIN + MALLINCKRODT 5MG/5ML + 10MG/5ML METHYLPHENIDATE HYDROCHLORIDE TRIS PHARMA INC 5MG/5ML 10MG/5ML

3 - 284 (of 424)

N021284 004 N021259 005 N021259 006

Apr 10, 2004 Feb 19, 2006 Feb 19, 2006

AA AA AA AA

N021419 001 N021419 002 A091601 001 A091601 002

Dec 19, 2002 Dec 19, 2002 Jul 23, 2010 Jul 23, 2010

TABLET; ORAL METHYLPHENIDATE HYDROCHLORIDE MALLINCKRODT 5MG AB 10MG AB 20MG AB UCB INC 5MG AB AB 10MG AB 20MG WATSON LABS AB 5MG AB 10MG AB 20MG RITALIN NOVARTIS AB 5MG AB 10MG AB + 20MG TABLET, CHEWABLE; ORAL METHYLIN MALLINCKRODT XX XX XX +

A040300 A040300 A040300 A086429 A085799 A086428 A040220 A040220 A040220

001 002 003 001 001 001 001 002 003

Nov 27, 1998 Nov 27, 1998 Nov 27, 1998

Aug 29, 1997 Aug 29, 1997 Aug 29, 1997

N010187 003 N010187 006 N010187 010

2.5MG 5MG 10MG

N021475 001 N021475 002 N021475 003

Apr 15, 2003 Apr 15, 2003 Apr 15, 2003

TABLET, EXTENDED RELEASE; ORAL METADATE ER UCB INC AB 10MG AB + 20MG METHYLIN ER MALLINCKRODT AB 10MG AB 20MG METHYLPHENIDATE HYDROCHLORIDE WATSON LABS AB 20MG RITALIN-SR NOVARTIS AB 20MG CONCERTA JANSSEN PHARMS 18MG XX 27MG XX 36MG XX 54MG XX +

A040306 001 A089601 001 A075629 001 A075629 002 A040410 001 N018029 001 N021121 N021121 N021121 N021121 001 004 002 003

Oct 20, 1999 Jun 01, 1988 May 09, 2000 May 09, 2000 Feb 09, 2001 Mar 30, 1982 Aug Apr Aug Dec 01, 01, 01, 08, 2000 2002 2000 2000

METHYLPREDNISOLONE
TABLET; ORAL MEDROL PHARMACIA AND UPJOHN AB AB AB AB + METHYLPREDNISOLONE DURAMED PHARMS BARR AB

4MG 8MG 16MG 32MG 4MG

N011153 N011153 N011153 N011153

001 004 003 006 Feb 21, 1984

A088497 001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

METHYLPREDNISOLONE
TABLET; ORAL METHYLPREDNISOLONE JUBILANT CADISTA AB AB AB AB SANDOZ AB VINTAGE PHARMS AB WATSON LABS AB

3 - 285 (of 424)

4MG 8MG 16MG 32MG 4MG 4MG 4MG

A040189 A040189 A040189 A040189 A040194 A040183 A040232

001 002 003 004 001 001 001

Oct Oct Jul Jul Oct Dec Oct

31, 31, 20, 20, 31, 22, 16,

1997 1997 2007 2007 1997 1998 1997

METHYLPREDNISOLONE ACETATE
INJECTABLE; INJECTION DEPO-MEDROL + PHARMACIA AND UPJOHN 40MG/ML + 80MG/ML METHYLPREDNISOLONE ACETATE SANDOZ 40MG/ML 40MG/ML 80MG/ML 80MG/ML TEVA PARENTERAL 40MG/ML 40MG/ML 80MG/ML 80MG/ML DEPO-MEDROL + PHARMACIA AND UPJOHN 20MG/ML

AB AB AB AB AB AB AB AB AB AB XX

N011757 001 N011757 004 A040719 A040794 A040719 A040794 A040557 A040620 A040557 A040620 001 001 002 002 001 001 002 002 Jan Mar Jan Mar Feb Oct Feb Oct 29, 05, 29, 05, 23, 27, 23, 27, 2009 2009 2009 2009 2005 2006 2005 2006

N011757 002

METHYLPREDNISOLONE SODIUM SUCCINATE

INJECTABLE; INJECTION A-METHAPRED HEMOFARM AP EQ 40MG BASE/VIAL AP EQ 125MG BASE/VIAL HOSPIRA AP EQ 40MG BASE/VIAL AP EQ 125MG BASE/VIAL METHYLPREDNISOLONE SODIUM SUCCINATE APP PHARMS AP EQ 40MG BASE/VIAL AP EQ 125MG BASE/VIAL AP EQ 1GM BASE/VIAL BEDFORD LABS AP EQ 40MG BASE/VIAL AP EQ 125MG BASE/VIAL AP EQ 500MG BASE/VIAL AP EQ 500MG BASE/VIAL AP EQ 1GM BASE/VIAL AP EQ 1GM BASE/VIAL MUSTAFA NEVSAT AP EQ 40MG BASE/VIAL AP EQ 125MG BASE/VIAL AP EQ 500MG BASE/VIAL AP EQ 1GM BASE/VIAL AP EQ 2GM BASE/VIAL TEVA PARENTERAL AP EQ 125MG BASE/VIAL SOLU-MEDROL AP + PHARMACIA AND UPJOHN EQ 40MG BASE/VIAL AP + EQ 125MG BASE/VIAL AP + EQ 500MG BASE/VIAL AP + EQ 1GM BASE/VIAL AP + EQ 2GM BASE/VIAL

A040793 A040827 A040664 A040665 A040583 A040583 A040612 A040662 A040641 A040641 A040709 A040641 A040709 A040888 A040888 A040888 A040888 A040888 A081266 N011856 N011856 N011856 N011856 N011856

001 001 001 001 001 002 001 001 002 003 001 004 002 001 002 003 004 005 001 003 004 005 006 007

Nov Nov Dec Dec Jul Jul Aug Feb Feb Feb Feb Feb Feb Jul Jul Jul Jul Jul Nov

25, 25, 20, 20, 30, 30, 12, 21, 21, 21, 21, 21, 21, 18, 18, 18, 18, 18, 30,

2008 2008 2005 2005 2004 2004 2004 2007 2007 2007 2007 2007 2007 2011 2011 2011 2011 2011 1992

Feb 27, 1985

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

METHYLTESTOSTERONE

CAPSULE; ORAL

TESTRED
XX + VALEANT PHARM INTL TABLET; ORAL ANDROID 10 BP VALEANT PHARM INTL ANDROID 25 BP + VALEANT PHARM INTL METHYLTESTOSTERONE BP IMPAX LABS BP

3 - 286 (of 424)

10MG

A083976 001

10MG 25MG 10MG 25MG

A086450 001 A087147 001 A080767 002 A084310 001

METIPRANOLOL HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC METIPRANOLOL FALCON PHARMS AT 0.3% OPTIPRANOLOL AT + BAUSCH AND LOMB 0.3%

A075720 001 N019907 001

Aug 06, 2001 Dec 29, 1989

METOCLOPRAMIDE HYDROCHLORIDE
INJECTABLE; INJECTION METOCLOPRAMIDE HYDROCHLORIDE HOSPIRA AP EQ 5MG BASE/ML TEVA PARENTERAL AP EQ 5MG BASE/ML REGLAN AP + BAXTER HLTHCARE CORP EQ 5MG BASE/ML SOLUTION; ORAL METOCLOPRAMIDE HYDROCHLORIDE ANI PHARMS EQ 5MG PHARM ASSOC EQ 5MG SILARX EQ 5MG VISTAPHARM EQ 5MG + WOCKHARDT EQ 5MG

A073118 001 A073135 001 N017862 001

Jan 17, 1991 Nov 27, 1991

AA AA AA AA AA

BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML

A071402 A072744 A073680 A075051 A074703

001 001 001 001 001

Jun May Oct Jan Oct

25, 28, 27, 26, 31,

1993 1991 1992 2001 1997

AB AB AB AB AB AB AB AB AB AB AB AB AB AB

TABLET; ORAL METOCLOPRAMIDE HYDROCHLORIDE ACTAVIS ELIZABETH EQ 10MG BASE IPCA LABS LTD EQ 5MG BASE EQ 10MG BASE MUTUAL PHARM EQ 5MG BASE NORTHSTAR HLTHCARE EQ 5MG BASE EQ 10MG BASE TEVA EQ 5MG BASE EQ 10MG BASE VINTAGE PHARMS EQ 5MG BASE EQ 10MG BASE WATSON LABS EQ 5MG BASE EQ 10MG BASE REGLAN ANI PHARMS EQ 5MG BASE + EQ 10MG BASE

A070581 A078807 A078807 A071536 A078374 A078374 A072801 A070184 A077878 A077878 A072750 A071250

001 001 002 002 001 002 001 001 001 002 001 001

Oct Jun Jun Jan Nov Nov Jun Jul Aug Aug Dec Feb

17, 12, 12, 16, 30, 30, 15, 29, 28, 28, 28, 03,

1985 2008 2008 1997 2007 2007 1993 1985 2006 2006 1995 1988

N017854 002 N017854 001

May 05, 1987

TABLET, ORALLY DISINTEGRATING; ORAL METOZOLV ODT SALIX PHARMS EQ 5MG BASE XX EQ 10MG BASE XX +

N022246 001 N022246 002

Sep 04, 2009 Sep 04, 2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

METOLAZONE
TABLET; ORAL METOLAZONE MYLAN AB AB AB SANDOZ AB AB AB TEVA AB AB AB ZAROXOLYN UCB INC AB AB + AB +

3 - 287 (of 424)

2.5MG 5MG 10MG 2.5MG 5MG 10MG 2.5MG 5MG 10MG 2.5MG 5MG 10MG

A076698 A076698 A076698 A076732 A076466 A076466 A076600 A076833 A075543

001 002 003 001 001 002 001 001 003

Dec Oct Oct Dec Dec Dec Jan Mar Dec

23, 19, 19, 19, 19, 19, 06, 01, 24,

2003 2004 2004 2003 2003 2003 2004 2004 2003

N017386 001 N017386 002 N017386 003

METOPROLOL SUCCINATE
TABLET, EXTENDED RELEASE; ORAL METOPROLOL SUCCINATE MYLAN PHARMS INC AB EQ 25MG TARTRATE AB EQ 50MG TARTRATE AB EQ 100MG TARTRATE AB EQ 200MG TARTRATE NESHER PHARMS AB EQ 25MG TARTRATE AB EQ 50MG TARTRATE AB EQ 100MG TARTRATE AB EQ 200MG TARTRATE SANDOZ AB EQ 25MG TARTRATE AB EQ 50MG TARTRATE AB EQ 100MG TARTRATE AB EQ 200MG TARTRATE WATSON LABS FLORIDA AB EQ 25MG TARTRATE AB EQ 50MG TARTRATE AB EQ 100MG TARTRATE AB EQ 200MG TARTRATE WOCKHARDT AB EQ 25MG TARTRATE AB EQ 50MG TARTRATE AB EQ 100MG TARTRATE AB EQ 200MG TARTRATE TOPROL-XL ASTRAZENECA AB EQ 25MG TARTRATE AB + EQ 50MG TARTRATE AB EQ 100MG TARTRATE AB + EQ 200MG TARTRATE

A202033 A202033 A202033 A202033 A077779 A077176 A076640 A076640 A076969 A076969 A076969 A076969 A077118 A076862 A077298 A077298 A090615 A090615 A090615 A090615 N019962 N019962 N019962 N019962

001 002 003 004 001 001 002 001 001 002 003 004 001 001 001 002 001 002 003 004 004 001 002 003

Dec Dec Dec Dec Mar May May May Jul May Mar Mar Aug Aug Apr Apr Jul Jul Jul Jul Feb Jan Jan Jan

15, 15, 15, 15, 20, 14, 18, 18, 31, 18, 20, 20, 03, 03, 15, 15, 22, 22, 22, 22, 05, 10, 10, 10,

2011 2011 2011 2011 2008 2008 2007 2007 2006 2007 2008 2008 2009 2009 2010 2010 2010 2010 2010 2010 2001 1992 1992 1992

METOPROLOL TARTRATE
INJECTABLE; INJECTION LOPRESSOR + NOVARTIS METOPROLOL TARTRATE APP PHARMS BEDFORD LABS HIKMA FARMACEUTICA HOSPIRA

AP AP AP AP AP AP AP AP AP AP

1MG/ML 1MG/ML 1MG/ML 1MG/ML 1MG/ML 1MG/ML 1MG/ML 1MG/ML 1MG/ML 1MG/ML

N018704 001 A091045 A076495 A077761 A074133 A075160 A078085 A090386 A091307 A090317 001 001 001 001 001 001 001 001 001

Mar 30, 1984 Oct Jul May Dec Jul Apr Sep Dec Apr 25, 07, 30, 21, 06, 29, 30, 29, 19, 2010 2003 2007 1993 1998 2008 2009 2010 2010

LUITPOLD SAGENT STRIDES

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

METOPROLOL TARTRATE
INJECTABLE; INJECTION METOPROLOL TARTRATE SANDOZ AP WATSON LABS AP TABLET; ORAL LOPRESSOR NOVARTIS AB AB METOPROLOL TARTRATE AUROBINDO PHARMA AB AB AB CARACO AB AB AB IPCA LABS LTD AB AB AB MUTUAL PHARM AB AB AB MYLAN AB AB AB + SANDOZ AB AB TEVA AB AB WATSON LABS AB AB

3 - 288 (of 424)

1MG/ML 1MG/ML

A077360 001 A074032 001

Oct 02, 2007 Dec 21, 1993

50MG 100MG 25MG 50MG 100MG 25MG 50MG 100MG 25MG 50MG 100MG 25MG 50MG 100MG 25MG 50MG 100MG 50MG 100MG 50MG 100MG 50MG 100MG

N017963 001 N017963 002 A077739 A077739 A077739 A076670 A074644 A074644 A078459 A078459 A078459 A073654 A073653 A073654 A076704 A076704 A076704 A073288 A073289 A074141 A074141 A074217 A074217 001 002 003 001 001 002 001 002 003 002 001 001 001 002 003 001 001 001 002 001 002 Sep Sep Sep Jan Dec Dec Jun Jun Jun Jul Dec Dec Jan Jan Jan Mar Mar Jan Jan May May 11, 11, 11, 15, 10, 10, 17, 17, 17, 15, 21, 21, 16, 16, 16, 25, 25, 31, 31, 27, 27, 2007 2007 2007 2004 1996 1996 2008 2008 2008 2009 1993 1993 2004 2004 2004 1994 1994 1995 1995 1994 1994

METRONIDAZOLE
CAPSULE; ORAL FLAGYL AB + GD SEARLE LLC METRONIDAZOLE ALEMBIC LTD AB PAR PHARM AB CREAM; TOPICAL METROCREAM + GALDERMA LABS LP METRONIDAZOLE ALTANA G AND W LABS NORITATE + SANOFI AVENTIS US GEL; TOPICAL METROGEL + GALDERMA LABS LP + METRONIDAZOLE ALTANA G AND W LABS INC TARO TOLMAR

375MG 375MG 375MG

N020334 001 A079065 001 A076522 001

May 03, 1995 Jun 23, 2009 Jan 29, 2004

AB AB AB XX

0.75% 0.75% 0.75% 1%

N020531 001 A076408 001 A077549 001 N020743 001

Sep 20, 1995 May 28, 2004 Dec 19, 2007 Sep 26, 1997

AB AB AB AB AB AB AB

0.75% 1% 0.75% 0.75% 0.75% 0.75% 1%

N019737 001 N021789 001 A077018 A078178 A077819 A077547 A090903 001 001 001 001 001

Nov 22, 1988 Jun 30, 2005 Jun Jan Jul Jul Jul 06, 19, 18, 13, 22, 2006 2011 2006 2006 2011

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

METRONIDAZOLE
GEL; VAGINAL METROGEL-VAGINAL AB + MEDICIS METRONIDAZOLE TOLMAR AB VANDAZOLE BX TEVA PHARMS

3 - 289 (of 424)

0.75% 0.75% 0.75%

N020208 001 A077264 001 N021806 001

Aug 17, 1992 Oct 31, 2006 May 20, 2005

AP AP AP AP AP

INJECTABLE; INJECTION FLAGYL I.V. RTU IN PLASTIC CONTAINER + BAXTER HLTHCARE 500MG/100ML + PFIZER 500MG/100ML METRO I.V. IN PLASTIC CONTAINER + B BRAUN 500MG/100ML METRONIDAZOLE IN PLASTIC CONTAINER CLARIS LIFESCIENCES 500MG/100ML + HOSPIRA 500MG/100ML

N018657 001 N018353 002 N018900 001 A078084 001 N018890 002 Sep 29, 1983 Mar 31, 2008 Nov 18, 1983

LOTION; TOPICAL METROLOTION AB + GALDERMA LABS LP METRONIDAZOLE ALTANA AB TABLET; ORAL FLAGYL GD SEARLE LLC AB AB + METRONIDAZOLE ALEMBIC PHARMS LTD AB AB MUTUAL PHARM AB AB PLIVA AB AB TEVA AB WATSON LABS AB AB AB

0.75% 0.75%

N020901 001 A077197 001

Nov 24, 1998 May 24, 2006

250MG 500MG 250MG 500MG 250MG 500MG 250MG 500MG 500MG 250MG 250MG 500MG

N012623 001 N012623 003 A079067 A079067 A070772 A070773 A070027 A070033 A070044 A070035 N018764 N018764 001 002 001 001 001 001 001 001 001 002 Mar Mar Jul Jul Nov Dec Feb Dec Sep Dec 13, 13, 16, 16, 06, 06, 08, 20, 17, 20, 2009 2009 1986 1986 1984 1984 1985 1984 1982 1982

TABLET, EXTENDED RELEASE; ORAL FLAGYL ER AB + GD SEARLE LLC 750MG METRONIDAZOLE ALEMBIC LTD AB 750MG

N020868 001 A090222 001

Nov 26, 1997 May 05, 2010

METYRAPONE
CAPSULE; ORAL
METOPIRONE
XX + NOVARTIS

250MG

N012911 002

Aug 09, 1996

METYROSINE
CAPSULE; ORAL
DEMSER
XX + ATON

250MG

N017871 001

MEXILETINE HYDROCHLORIDE
CAPSULE; ORAL MEXILETINE HYDROCHLORIDE TEVA AB 150MG AB 200MG AB + 250MG

A074377 001 A074377 002 A074377 003

May 16, 1995 May 16, 1995 May 16, 1995

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

MEXILETINE HYDROCHLORIDE
CAPSULE; ORAL MEXILETINE HYDROCHLORIDE WATSON LABS 150MG 150MG 200MG 200MG 250MG 250MG

3 - 290 (of 424)

AB AB AB AB AB AB

A074711 A074865 A074711 A074865 A074711 A074865

001 001 002 002 003 003

Feb Apr Feb Apr Feb Apr

26, 13, 26, 13, 26, 13,

1997 1998 1997 1998 1997 1998

MICAFUNGIN SODIUM
INJECTABLE; IV (INFUSION)
MYCAMINE
XX + ASTELLAS 50MG/VIAL XX + 100MG/VIAL

N021506 002 N021506 003

Mar 16, 2005 Jun 27, 2006

MICONAZOLE

TABLET; BUCCAL

ORAVIG
XX + BIOALLIANCE PHARMA

50MG

N022404 001

Apr 16, 2010

MICONAZOLE NITRATE
SUPPOSITORY; VAGINAL MICONAZOLE NITRATE ACTAVIS MID ATLANTIC AB MONISTAT 3 AB + INSIGHT PHARMS

200MG 200MG

A073508 001 N018888 001

Nov 19, 1993 Aug 15, 1984

MICONAZOLE NITRATE; PETROLATUM, WHITE; ZINC OXIDE

OINTMENT; TOPICAL

VUSION
XX + STIEFEL LABS INC

0.25%;81.35%;15%

N021026 001

Feb 16, 2006

MIDAZOLAM HYDROCHLORIDE
INJECTABLE; INJECTION MIDAZOLAM HYDROCHLORIDE APP PHARMS AP EQ AP EQ BAXTER HLTHCARE AP EQ AP EQ BAXTER HLTHCARE CORP EQ AP AP EQ BEDFORD AP EQ AP EQ BEN VENUE AP EQ AP EQ CLARIS LIFESCIENCES AP EQ AP EQ AP + HOSPIRA EQ AP EQ AP + EQ AP EQ INTL MEDICATED AP EQ AP EQ INTL MEDICATION AP EQ AP EQ TAYLOR AP EQ AP EQ AP EQ

1MG 5MG 1MG 5MG 1MG 5MG 1MG 5MG 1MG 5MG 1MG 5MG 1MG 1MG 5MG 5MG 1MG 5MG 1MG 5MG 1MG 5MG 5MG

BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML

A075154 A075154 A075243 A075243 A075324 A075324 A075247 A075247 A075421 A075421 A075637 A075637 A075293 A075856 A075293 A075856 A076144 A076144 A076020 A076020 A075494 A075481 A075494

002 001 001 002 001 002 002 001 002 001 001 002 001 001 002 002 001 002 001 002 001 001 002

Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Oct Oct Jun Jun Jun Jun Jan Jan Jul Jul Jun Jun Jun

20, 20, 20, 20, 20, 20, 23, 23, 20, 20, 31, 31, 20, 13, 20, 13, 26, 26, 16, 16, 30, 30, 30,

2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2002 2000 2002 2005 2005 2004 2004 2000 2000 2000

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

MIDAZOLAM HYDROCHLORIDE
INJECTABLE; INJECTION MIDAZOLAM HYDROCHLORIDE WOCKHARDT EQ 1MG BASE/ML AP EQ 1MG BASE/ML AP EQ 5MG BASE/ML AP EQ 5MG BASE/ML AP MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE EQ 1MG BASE/ML AP + HOSPIRA EQ 5MG BASE/ML AP + SAGENT STRIDES AP EQ 1MG BASE/ML AP EQ 5MG BASE/ML MIDOZALAM HYDROCHLORIDE SAGENT STRIDES AP EQ 1MG BASE/ML AP EQ 5MG BASE/ML SYRUP; ORAL MIDAZOLAM HYDROCHLORIDE APOTEX INC HI TECH PHARMA PADDOCK LLC RANBAXY + ROXANE

3 - 291 (of 424)

A078141 A078511 A078141 A078511 A075857 A075857 A090315 A090315

001 001 002 002 001 002 001 002

May Nov May Nov Jul Jul Nov Nov

30, 10, 30, 10, 22, 22, 29, 29,

2008 2008 2008 2008 2002 2002 2010 2010

A090316 001 A090316 002

May 04, 2011 May 04, 2011

AA AA AA AA AA

EQ EQ EQ EQ EQ

2MG 2MG 2MG 2MG 2MG

BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML

A077115 A075958 A076379 A076058 A075873

001 001 001 001 001

Sep Sep May Mar Apr

09, 04, 02, 15, 30,

2005 2003 2005 2002 2002

MIDODRINE HYDROCHLORIDE
TABLET; ORAL MIDODRINE HYDROCHLORIDE APOTEX INC 2.5MG AB 5MG AB 10MG AB IMPAX PHARMS 2.5MG AB 5MG AB 10MG AB MYLAN 2.5MG AB 5MG AB 10MG AB SANDOZ 2.5MG AB 5MG AB 10MG AB ORVATEN UPSHER SMITH AB 2.5MG AB 5MG AB 10MG PROAMATINE SHIRE AB 2.5MG AB + 5MG AB 10MG

A077746 A077746 A077746 A076449 A076449 A076449 A076577 A076577 A076577 A076514 A076514 A076514

001 002 003 001 002 003 001 002 003 001 002 003

Sep Sep Sep May May Dec Sep Sep Sep Sep Sep Jul

12, 12, 12, 27, 27, 16, 10, 10, 10, 11, 11, 02,

2006 2006 2006 2004 2004 2005 2003 2003 2003 2003 2003 2004

A076725 001 A076725 002 A076725 003 N019815 001 N019815 002 N019815 003

Nov 03, 2004 Nov 03, 2004 Nov 03, 2004 Sep 06, 1996 Sep 06, 1996 Mar 20, 2002

MIFEPRISTONE
TABLET; ORAL
MIFEPREX
XX + DANCO LABS LLC

200MG

N020687 001

Sep 28, 2000

MIGLITOL
TABLET; ORAL GLYSET XX PHARMACIA AND UPJOHN XX XX +

25MG 50MG 100MG

N020682 001 N020682 002 N020682 003

Dec 18, 1996 Dec 18, 1996 Dec 18, 1996

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

MIGLUSTAT
CAPSULE; ORAL

ZAVESCA

XX + ACTELION PHARMS LTD

3 - 292 (of 424)

100MG

N021348 001

Jul 31, 2003

MILNACIPRAN HYDROCHLORIDE
TABLET; ORAL SAVELLA CYPRESS BIOSCIENCE XX XX XX + XX

12.5MG 25MG 50MG 100MG

N022256 N022256 N022256 N022256

001 002 003 004

Jan Jan Jan Jan

14, 14, 14, 14,

2009 2009 2009 2009

MILRINONE LACTATE
INJECTABLE; INJECTION MILRINONE LACTATE APP PHARMS EQ 1MG BASE/ML BAXTER HLTHCARE EQ 1MG BASE/ML + BEDFORD EQ 1MG BASE/ML CLARIS LIFESCIENCES EQ 1MG BASE/ML GLAND PHARMA LTD EQ 1MG BASE/ML HIKMA FARMACEUTICA EQ 1MG BASE/ML INTL MEDICATED EQ 1MG BASE/ML MILRINONE LACTATE IN DEXTROSE 5% CLARIS LIFESCIENCES EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER B BRAUN EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) + BAXTER HLTHCARE EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) + EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) BEDFORD LABS EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) CLARIS LIFESCIENCES EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) HOSPIRA EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) MILRINONE LACTATE IN PLASTIC CONTAINER HIKMA FARMACEUTICA EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)

AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP

A075936 A075530 A075660 A076427 A077190 A077966 A076013

001 001 001 001 001 001 001

May May May Sep Oct Dec Aug

28, 28, 28, 21, 31, 03, 02,

2002 2002 2002 2004 2006 2010 2002

A077151 002 A076414 A075834 A075834 A078113 A078113 A077151 A075885 A075885 001 001 002 001 002 001 001 002

Jul 20, 2005 Aug May May May May Jul May May 18, 28, 28, 21, 21, 20, 28, 28, 2004 2002 2002 2008 2008 2005 2002 2002

A090038 001 A090038 002

Jan 21, 2010 Jan 21, 2010

MINOCYCLINE HYDROCHLORIDE
CAPSULE; ORAL DYNACIN MEDICIS AB EQ AB EQ MINOCIN TRIAX PHARMS LLC AB EQ AB EQ MINOCYCLINE HYDROCHLORIDE AUROBINDO PHARMA AB EQ AB EQ AB EQ IMPAX LABS AB EQ AB EQ AB EQ RANBAXY AB EQ AB EQ AB EQ TEVA AB EQ AB EQ AB + EQ WATSON LABS AB EQ

75MG BASE 100MG BASE 50MG BASE 100MG BASE 50MG BASE 75MG BASE 100MG BASE 50MG BASE 75MG BASE 100MG BASE 50MG BASE 75MG BASE 100MG BASE 50MG BASE 75MG BASE 100MG BASE 50MG BASE

A063067 002 A063067 001 N050649 001 N050649 002 A065470 A065470 A065470 A065005 A065005 A065005 A065062 A065062 A065062 A063011 A063009 A063009 A063181 001 002 003 001 003 002 001 002 003 001 002 001 001

Sep 15, 1999 Jul 31, 1990 May 31, 1990 May 31, 1990 Mar Mar Mar Mar Apr Mar Nov Nov Nov Mar Aug Mar Dec 11, 11, 11, 23, 18, 23, 30, 30, 30, 02, 12, 02, 30, 2008 2008 2008 1999 2001 1999 2000 2000 2000 1992 2003 1992 1991

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

MINOCYCLINE HYDROCHLORIDE
CAPSULE; ORAL MINOCYCLINE HYDROCHLORIDE WATSON LABS AB EQ 75MG BASE AB EQ 100MG BASE INJECTABLE; INJECTION

MINOCIN

XX + TRIAX PHARMS LLC

3 - 293 (of 424)

A063065 002 A063065 001

Jun 10, 1999 Dec 30, 1991

EQ 100MG BASE/VIAL

N050444 001

POWDER, EXTENDED RELEASE; DENTAL

ARESTIN

EQ 1MG BASE XX + ORAPHARMA TABLET; ORAL MINOCYCLINE HYDROCHLORIDE DR REDDYS LABS LTD AB EQ AB EQ AB EQ PAR PHARM AB EQ AB EQ AB + EQ RANBAXY AB EQ AB EQ AB EQ

N050781 001

Feb 16, 2001

50MG BASE 75MG BASE 100MG BASE 50MG BASE 75MG BASE 100MG BASE 50MG BASE 75MG BASE 100MG BASE

A065436 A065436 A065436 A065131 A065131 A065131 A065156 A065156 A065156

001 002 003 001 002 003 001 002 003

Dec Dec Dec Apr Apr Apr Jan Jan Jan

26, 26, 26, 16, 16, 16, 06, 06, 06,

2007 2007 2007 2003 2003 2003 2004 2004 2004

AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB XX XX XX XX XX

TABLET, EXTENDED RELEASE; ORAL MINOCYCLINE HYDROCHLORIDE BARR EQ 45MG BASE EQ 90MG BASE EQ 135MG BASE IMPAX LABS INC EQ 45MG BASE EQ 90MG BASE EQ 135MG BASE LUPIN LTD EQ 45MG BASE EQ 90MG BASE EQ 135MG BASE MATRIX LABS LTD EQ 45MG BASE EQ 90MG BASE EQ 135MG BASE SANDOZ EQ 45MG BASE EQ 90MG BASE EQ 135MG BASE SOLODYN MEDICIS EQ 45MG BASE EQ 90MG BASE + EQ 135MG BASE SOLODYN MEDICIS EQ 55MG BASE EQ 65MG BASE EQ 80MG BASE EQ 105MG BASE EQ 115MG BASE

A065485 A065485 A065485 A090024 A090024 A090024 A091424 A091424 A091424 A090911 A090911 A090911 A090422 A090422 A090422

001 002 003 001 002 003 001 003 004 001 002 003 001 002 003

Mar Mar Mar Feb Feb Feb Nov Nov Nov Jul Jul Jul Aug Aug Aug

17, 17, 17, 03, 03, 03, 30, 30, 30, 20, 20, 20, 13, 13, 13,

2009 2009 2009 2009 2009 2009 2011 2011 2011 2010 2010 2010 2009 2009 2009

N050808 001 N050808 002 N050808 003 N050808 N050808 N050808 N050808 N050808 008 004 007 006 005

May 08, 2006 May 08, 2006 May 08, 2006 Aug Jul Aug Aug Jul 27, 23, 27, 27, 23, 2010 2009 2010 2010 2009

MINOXIDIL
TABLET; ORAL MINOXIDIL MUTUAL PHARM AB AB PAR PHARM AB AB WATSON LABS AB AB +

2.5MG 10MG 2.5MG 10MG 2.5MG 10MG

A072708 A072709 A071826 A071839 A071344 A071345

001 001 001 001 001 001

Dec Dec Nov Nov Mar Mar

14, 14, 14, 14, 03, 03,

1995 1995 1988 1988 1987 1987

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

MIRTAZAPINE
TABLET; ORAL MIRTAZAPINE ALPHAPHARM AB AB AB APOTEX INC AB AB AB AUROBINDO AB AB AB AB CARACO AB AB AB AB MYLAN AB AB AB SANDOZ AB AB AB TEVA AB AB AB WATSON LABS AB AB AB WATSON LABS FLORIDA AB AB AB REMERON AB + ORGANON USA INC AB AB

3 - 294 (of 424)

15MG 30MG 45MG 15MG 30MG 45MG 7.5MG 15MG 30MG 45MG 7.5MG 15MG 30MG 45MG 15MG 30MG 45MG 15MG 30MG 45MG 15MG 30MG 45MG 15MG 30MG 45MG 15MG 30MG 45MG 15MG 30MG 45MG

A076176 A076176 A076176 A077666 A077666 A077666 A076921 A076921 A076921 A076921 A076541 A076541 A076541 A076541 A076122 A076122 A076122 A076219 A076219 A076219 A076119 A076119 A076119 A076312 A076312 A076312 A076336 A076336 A076336

001 002 003 001 002 003 001 002 003 004 004 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003

Jun Jun Jun Aug Aug Aug Oct Oct Oct Oct Apr Apr Apr Apr Jun Jun Jun Jun Jun Jun Jan Jan Jun Jun Jun Jun Jun Jun Jun

19, 19, 19, 22, 22, 22, 22, 22, 22, 22, 22, 22, 22, 22, 19, 19, 19, 19, 19, 19, 24, 24, 19, 19, 19, 19, 20, 20, 20,

2003 2003 2003 2007 2007 2007 2004 2004 2004 2004 2004 2004 2004 2004 2003 2003 2003 2003 2003 2003 2003 2003 2003 2003 2003 2003 2003 2003 2003

N020415 001 N020415 002 N020415 003

Jun 14, 1996 Jun 14, 1996 Mar 17, 1997

AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB

TABLET, ORALLY DISINTEGRATING; ORAL MIRTAZAPINE ACTAVIS ELIZABETH 15MG 30MG 45MG AUROBINDO PHARMA LTD 15MG 30MG 45MG TEVA 15MG 30MG 45MG WATSON LABS 15MG 30MG 45MG REMERON SOLTAB + ORGANON USA INC 15MG 30MG 45MG

A077959 A077959 A077959 A077376 A077376 A077376 A076901 A076901 A076901 A076307 A076307 A076307

001 002 003 002 003 004 001 002 003 001 002 003

Feb Feb Feb Dec Dec Feb Jun Jun Jun Dec Dec Feb

14, 14, 14, 08, 08, 28, 28, 28, 28, 17, 17, 28,

2011 2011 2011 2005 2005 2006 2005 2005 2005 2003 2003 2006

N021208 001 N021208 002 N021208 003

Jan 12, 2001 Jan 12, 2001 Jan 12, 2001

MISOPROSTOL
TABLET; ORAL CYTOTEC GD SEARLE LLC AB AB +

0.1MG 0.2MG

N019268 003 N019268 001

Sep 21, 1990

Dec 27, 1988

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

MISOPROSTOL
TABLET; ORAL MISOPROSTOL IVAX SUB TEVA PHARMS AB AB

3 - 295 (of 424)

0.1MG 0.2MG

A076095 001 A076095 002

Jul 10, 2002 Jul 10, 2002

MITOMYCIN
INJECTABLE; INJECTION MITOMYCIN + ACCORD HLTHCARE + + BAXTER HLTHCARE BEDFORD

AP AP AP AP AP AP AP

5MG/VIAL 20MG/VIAL 40MG/VIAL 5MG/VIAL 20MG/VIAL 5MG/VIAL 20MG/VIAL

A064144 A064144 A064144 A064180 A064180 A064117 A064117

001 002 003 001 002 001 002

Apr Apr Aug Dec Dec Apr Apr

30, 30, 11, 23, 23, 19, 19,

1998 1998 2009 1999 1999 1995 1995

MITOTANE
TABLET; ORAL

LYSODREN

XX + BRISTOL MYERS SQUIBB

500MG

N016885 001

MITOXANTRONE HYDROCHLORIDE
INJECTABLE; INJECTION MITOXANTRONE HYDROCHLORIDE APP PHARMS EQ EQ EQ BEDFORD EQ EQ EQ FRESENIUS KABI ONCOL EQ EQ EQ + HOSPIRA EQ + EQ + EQ MYLAN INSTITUTIONAL EQ EQ TEVA PARENTERAL EQ EQ EQ

AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP

20MG 25MG 30MG 20MG 25MG 30MG 20MG 25MG 30MG 20MG 25MG 30MG 20MG 30MG 20MG 25MG 30MG

BASE/10ML (EQ 2MG BASE/ML) BASE/12.5ML (EQ 2MG BASE/ML) BASE/15ML (EQ 2MG BASE/ML) BASE/10ML (EQ 2MG BASE/ML) BASE/12.5ML (EQ 2MG BASE/ML) BASE/15ML (EQ 2MG BASE/ML) BASE/10ML (EQ 2MG BASE/ML) BASE/12.5ML (EQ 2MG BASE/ML) BASE/15ML (EQ 2MG BASE/ML) BASE/10ML (EQ 2MG BASE/ML) BASE/12.5ML (EQ 2MG BASE/ML) BASE/15ML (EQ 2MG BASE/ML) BASE/10ML (EQ 2MG BASE/ML) BASE/15ML (EQ 2MG BASE/ML) BASE/10ML (EQ 2MG BASE/ML) BASE/12.5ML (EQ 2MG BASE/ML) BASE/15ML (EQ 2MG BASE/ML)

A077496 A077496 A077496 A076611 A076611 A076611 A078606 A078606 A078606 A076871 A076871 A076871 A078980 A078980 A077356 A077356 A077356

001 002 003 001 002 003 001 002 003 001 002 003 001 002 001 002 003

Apr Apr Apr Apr Apr Apr May May May Apr Apr Apr Apr Apr Apr Apr Apr

11, 11, 11, 11, 11, 11, 14, 14, 14, 11, 11, 11, 13, 13, 11, 11, 11,

2006 2006 2006 2006 2006 2006 2008 2008 2008 2006 2006 2006 2009 2009 2006 2006 2006

MODAFINIL
TABLET; ORAL PROVIGIL CEPHALON XX XX +

100MG 200MG

N020717 001 N020717 002

Dec 24, 1998 Dec 24, 1998

MOEXIPRIL HYDROCHLORIDE
TABLET; ORAL MOEXIPRIL HYDROCHLORIDE APOTEX INC AB 7.5MG AB 15MG GLENMARK GENERICS AB 7.5MG AB 15MG PADDOCK LLC AB 7.5MG AB 15MG TEVA AB 7.5MG

A078454 A078454 A090416 A090416 A077536 A077536 A076204

001 002 001 002 001 002 001

Jun Jun Mar Mar Nov Nov May

02, 02, 30, 30, 30, 30, 08,

2008 2008 2010 2010 2006 2006 2003

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

MOEXIPRIL HYDROCHLORIDE
TABLET; ORAL MOEXIPRIL HYDROCHLORIDE TEVA AB 15MG UNIVASC UCB INC AB 7.5MG AB + 15MG

3 - 296 (of 424)

A076204 002 N020312 001 N020312 002

May 08, 2003 Apr 19, 1995 Apr 19, 1995

MOMETASONE FUROATE
CREAM; TOPICAL ELOCON + SCHERING MOMETASONE FUROATE ALTANA G AND W LABS GLENMARK GENERICS TARO TOLMAR LOTION; TOPICAL ELOCON + SCHERING MOMETASONE FUROATE G AND W LABS GLENMARK GENERICS NYCOMED US PERRIGO TARO TOLMAR OINTMENT; TOPICAL ELOCON + SCHERING MOMETASONE FUROATE ALTANA G AND W LABS GLENMARK GENERICS PERRIGO NEW YORK TARO TOLMAR

AB AB AB AB AB AB

0.1% 0.1% 0.1% 0.1% 0.1% 0.1%

N019625 001 A076171 A077447 A078541 A076679 A076591 001 001 001 001 001

May 06, 1987 Apr May May Dec Apr 08, 22, 28, 21, 18, 2005 2006 2008 2004 2007

AB AB AB AB AB AB AB

0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 0.1%

N019796 001 A077678 A090506 A075919 A077180 A076788 A076499 001 001 001 001 001 001

Mar 30, 1989 Nov Aug Nov Apr Mar Nov 21, 09, 29, 06, 15, 21, 2007 2010 2007 2005 2006 2007

AB AB AB AB AB AB AB

0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 0.1%

N019543 001 A077061 A077401 A078571 A076067 A076624 A076481 001 001 001 001 001 001

Apr 30, 1987 Mar Jun May Mar Dec Nov 28, 20, 28, 18, 03, 14, 2005 2006 2008 2002 2004 2003

POWDER; INHALATION ASMANEX TWISTHALER SCHERING XX XX +

0.11MG/INH 0.22MG/INH

N021067 002 N021067 001

Feb 01, 2008 Mar 30, 2005

MOMETASONE FUROATE MONOHYDRATE

SPRAY, METERED; NASAL

NASONEX
XX + SCHERING PLOUGH

EQ 0.05MG BASE/SPRAY

N020762 001

Oct 01, 1997

MONTELUKAST SODIUM
GRANULE; ORAL

SINGULAIR

XX + MERCK TABLET; ORAL

SINGULAIR

XX + MERCK TABLET, CHEWABLE; ORAL SINGULAIR MERCK XX XX +

EQ 4MG BASE/PACKET

N021409 001

Jul 26, 2002

EQ 10MG BASE

N020829 002

Feb 20, 1998

EQ 4MG BASE EQ 5MG BASE

N020830 002 N020830 001

Mar 03, 2000 Feb 20, 1998

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

MORPHINE SULFATE
CAPSULE, EXTENDED RELEASE; ORAL KADIAN ACTAVIS ELIZABETH 20MG 30MG 50MG 60MG 80MG + 100MG MORPHINE SULFATE WATSON LABS 20MG 30MG 50MG 60MG 80MG 100MG AVINZA KING PHARMS 30MG 60MG AVINZA KING PHARMS 45MG 75MG 90MG + 120MG KADIAN + ACTAVIS ELIZABETH 10MG + 200MG

3 - 297 (of 424)

AB AB AB AB AB AB AB AB AB AB AB AB BX BX XX XX XX XX XX XX

N020616 N020616 N020616 N020616 N020616 N020616 A200812 A200812 A200812 A200812 A200812 A200812

001 004 002 005 006 003 001 002 003 004 005 006

Jul Mar Jul Mar Oct Jul Nov Nov Nov Nov Nov Nov

03, 09, 03, 09, 27, 03, 10, 10, 10, 10, 10, 10,

1996 2001 1996 2001 2006 1996 2011 2011 2011 2011 2011 2011

N021260 001 N021260 002 N021260 N021260 N021260 N021260 005 006 003 004

Mar 20, 2002 Mar 20, 2002 Dec Dec Mar Mar 18, 18, 20, 20, 2008 2008 2002 2002

N020616 008 N020616 007

Apr 20, 2007 Feb 27, 2007

INJECTABLE; INJECTION ASTRAMORPH PF APP PHARMS AP AP AP AP DURAMORPH PF AP + BAXTER HLTHCARE AP + MORPHINE SULFATE HOSPIRA AP AP AP AP AP + WATSON LABS AP AP AP AP INFUMORPH XX + BAXTER HLTHCARE XX + MORPHINE SULFATE XX + HOSPIRA XX + HOSPIRA INC XX + XX + XX + XX + XX + MERIDIAN MEDCL TECHN

0.5MG/ML 0.5MG/ML 1MG/ML 1MG/ML 0.5MG/ML 1MG/ML 0.5MG/ML 0.5MG/ML 1MG/ML 1MG/ML 1MG/ML 0.5MG/ML 0.5MG/ML 1MG/ML 1MG/ML 10MG/ML 25MG/ML 5MG/ML 2MG/ML 4MG/ML 8MG/ML 10MG/ML 15MG/ML 15MG/ML

A071050 A071051 A071052 A071053

001 001 001 001

Oct Oct Oct Oct

07, 07, 07, 07,

1986 1986 1986 1986

N018565 001 N018565 002 A071849 A073509 A071850 A073510 N019916 A073373 A073375 A073374 A073376 001 001 001 001 001 001 001 001 001

Sep 18, 1984 Sep 18, 1984 May Sep May Sep Oct Sep Sep Sep Sep 11, 30, 11, 30, 30, 30, 30, 30, 30, 1988 1992 1988 1992 1992 1991 1991 1991 1991

N018565 003 N018565 004 N019916 N202515 N202515 N202515 N202515 N202515 N019999 002 001 002 003 004 005 001

Jul 19, 1991 Jul 19, 1991 Oct Nov Nov Nov Nov Nov Jul 27, 14, 14, 14, 14, 14, 12, 2006 2011 2011 2011 2011 2011 1990

INJECTABLE, LIPOSOMAL; EPIDURAL DEPODUR 10MG/ML (10MG/ML) XX + EKR THERAP

N021671 001

May 18, 2004

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

MORPHINE SULFATE
SOLUTION; ORAL MORPHINE SULFATE MALLINCKRODT INC AA ROXANE AA AA AA + VISTAPHARM AA AA MORPHINE SULFATE LANNETT HOLDINGS INC XX TABLET; ORAL MORPHINE SULFATE ROXANE XX XX +

3 - 298 (of 424)

100MG/5ML 10MG/5ML 20MG/5ML 100MG/5ML 10MG/5ML 20MG/5ML 20MG/ML

A202348 N022195 N022195 N022195 A201947 A201947

001 001 002 003 001 002

Jul Mar Mar Jan Jan Jan

15, 17, 17, 25, 05, 05,

2011 2008 2008 2010 2012 2012

N201517 001

Jun 23, 2011

15MG 30MG

N022207 001 N022207 002

Mar 17, 2008 Mar 17, 2008

TABLET, EXTENDED RELEASE; ORAL MORPHINE SULFATE CLONMEL HLTHCARE AB 15MG ENDO PHARMS AB 15MG AB 30MG AB 60MG AB 100MG AB 200MG MALLINCKRODT AB 15MG AB 30MG AB 60MG AB 100MG AB 200MG MYLAN PHARMS INC AB 15MG AB 30MG AB 60MG AB 100MG AB 200MG NESHER PHARMS AB 15MG AB 30MG AB 60MG AB 100MG AB 200MG RHODES PHARMS AB 15MG AB 30MG AB 60MG AB 100MG AB 200MG MS CONTIN PURDUE PHARMA LP AB 15MG AB 30MG AB 60MG AB + 100MG AB 200MG ORAMORPH SR BC XANODYNE PHARM 15MG BC 30MG BC 60MG BC + 100MG

A075407 A075295 A075295 A075295 A075295 A075295 A076412 A076412 A076412 A076438 A076438 A200824 A200824 A200824 A200824 A200824 A076733 A076720 A076720 A077855 A077855 A074862 A074862 A074862 A074769 A074769 N019516 N019516 N019516 N019516 N019516 N019977 N019977 N019977 N019977

001 001 002 003 004 005 001 002 003 001 002 001 002 003 004 005 001 002 001 001 002 001 002 003 001 002 003 001 002 004 005 004 001 002 003

Jan Oct Oct Oct Sep Sep Jul Jul Jul Jul Jul Oct Oct Oct Oct Oct May Dec May Sep Sep Jul Jul Jul Jul Jul Sep May Apr Jan Nov Nov Aug Aug Aug

28, 28, 28, 28, 15, 15, 31, 31, 31, 03, 03, 18, 18, 18, 18, 18, 19, 23, 19, 27, 27, 07, 07, 07, 02, 02, 12, 29, 08, 16, 08, 23, 15, 15, 15,

2000 1998 1998 1998 2000 2000 2003 2003 2003 2003 2003 2011 2011 2011 2011 2011 2004 2005 2004 2007 2007 1998 1998 1998 1998 1998 1989 1987 1988 1990 1993 1994 1991 1991 1991

MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE; ORAL
EMBEDA
ALPHARMA KING 20MG;0.8MG XX 30MG;1.2MG XX

N022321 001 N022321 002

Aug 13, 2009 Aug 13, 2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL EMBEDA ALPHARMA KING 50MG;2MG XX 60MG;2.4MG XX 80MG;3.2MG XX 100MG;4MG XX +

3 - 299 (of 424)

N022321 N022321 N022321 N022321

003 004 005 006

Aug Aug Aug Aug

13, 13, 13, 13,

2009 2009 2009 2009

MOXIFLOXACIN HYDROCHLORIDE
INJECTABLE; IV (INFUSION)

AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER

160MG/100ML XX + BAYER HLTHCARE SOLUTION/DROPS; OPHTHALMIC
MOXEZA
XX + ALCON PHARMS LTD EQ 0.5% BASE VIGAMOX EQ 0.5% BASE XX + ALCON PHARMS LTD TABLET; ORAL

AVELOX

XX + BAYER HLTHCARE

N021277 001

Nov 30, 2001

N022428 001 N021598 001

Nov 19, 2010 Apr 15, 2003

EQ 400MG BASE

N021085 001

Dec 10, 1999

MUPIROCIN
OINTMENT; TOPICAL BACTROBAN + GLAXOSMITHKLINE MUPIROCIN ALTANA GLENMARK PHARMS PERRIGO NEW YORK TARO TEVA CENTANY PERRIGO NEW YORK

AB AB AB AB AB AB BX

2% 2% 2% 2% 2% 2% 2%

N050591 001 A065192 A090480 A065123 A065170 A065085 001 001 001 001 001

Dec 31, 1987 Nov Jun Nov Sep Nov 30, 08, 07, 23, 07, 2005 2011 2003 2005 2003

N050788 001

Dec 04, 2002

MUPIROCIN CALCIUM

CREAM; TOPICAL

BACTROBAN
XX + GLAXOSMITHKLINE
OINTMENT; NASAL

BACTROBAN
XX + GLAXOSMITHKLINE

EQ 2% BASE

N050746 001

Dec 11, 1997

EQ 2% BASE

N050703 001

Sep 18, 1995

MYCOPHENOLATE MOFETIL
CAPSULE; ORAL CELLCEPT + ROCHE PALO MYCOPHENOLATE MOFETIL ACCORD HLTHCARE INC APOTEX CORP DR REDDYS LABS LTD ENDO PHARMS MYLAN ROXANE SANDOZ STRIDES ARCOLAB LTD TEVA PHARMS ZYDUS PHARMS USA INC

AB AB AB AB AB AB AB AB AB AB AB

250MG 250MG 250MG 250MG 250MG 250MG 250MG 250MG 250MG 250MG 250MG

N050722 001 A090253 A090419 A091315 A090111 A065520 A065410 A065379 A090055 A065491 A065433 001 001 001 001 001 001 001 001 001 001

May 03, 1995 May Apr Oct Dec May Jul Oct Jun May May 04, 22, 27, 22, 04, 29, 15, 10, 06, 04, 2009 2009 2011 2009 2009 2008 2008 2010 2009 2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

MYCOPHENOLATE MOFETIL
SUSPENSION; ORAL

CELLCEPT

XX + ROCHE PALO TABLET; ORAL CELLCEPT + ROCHE PALO MYCOPHENOLATE MOFETIL ACCORD HLTHCARE ALKEM LABS LTD APOTEX ENDO PHARMS MYLAN ROXANE SANDOZ STRIDES ARCOLAB LTD TEVA PHARMS ZYDUS PHARMS USA INC

3 - 300 (of 424)

200MG/ML

N050759 001

Oct 01, 1998

AB AB AB AB AB AB AB AB AB AB AB

500MG 500MG 500MG 500MG 500MG 500MG 500MG 500MG 500MG 500MG 500MG

N050723 001 A065416 A091249 A090499 A090606 A065521 A065413 A065451 A090456 A065457 A065477 001 001 001 001 001 001 001 001 001 001

Jun 19, 1997 May Nov Apr Jul May Jul Oct Jun May May 04, 04, 22, 16, 04, 29, 15, 10, 04, 04, 2009 2011 2009 2010 2009 2008 2008 2010 2009 2009

MYCOPHENOLATE MOFETIL HYDROCHLORIDE

INJECTABLE; INJECTION

CELLCEPT

XX + ROCHE PALO

500MG/VIAL

N050758 001

Aug 12, 1998

MYCOPHENOLIC ACID
TABLET, DELAYED RELEASE; ORAL MYFORTIC NOVARTIS 180MG XX 360MG XX +

N050791 001 N050791 002

Feb 27, 2004 Feb 27, 2004

NABILONE
CAPSULE; ORAL

CESAMET

XX + MEDA PHARMS

1MG

N018677 001

Dec 26, 1985

NABUMETONE
TABLET; ORAL NABUMETONE APOTEX INC AB AB DR REDDYS LABS LTD AB AB INVAGEN PHARMS AB AB LUPIN LTD AB AB MATRIX LABS LTD AB AB PAR PHARM AB AB SANDOZ AB AB TEVA AB AB + WATSON LABS AB AB

500MG 750MG 500MG 750MG 500MG 750MG 500MG 750MG 500MG 750MG 500MG 750MG 500MG 750MG 500MG 750MG 500MG 750MG

A090427 A090427 A078420 A078420 A078671 A078671 A090445 A090445 A090516 A090516 A076009 A076009 A075280 A075280 A075189 A075189 A091083 A091083

001 002 001 002 001 002 001 002 001 002 001 002 001 002 001 002 001 002

Dec Dec Sep Sep Mar Mar Jan Jan Jul Jul Jan Jan Feb Feb May Sep Jun Jun

30, 30, 24, 24, 07, 07, 12, 12, 12, 12, 24, 24, 25, 25, 26, 24, 13, 13,

2011 2011 2008 2008 2008 2008 2011 2011 2010 2010 2003 2003 2002 2002 2000 2001 2011 2011

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

NADOLOL
TABLET; ORAL CORGARD KING PHARMS AB AB AB + NADOLOL IVAX SUB TEVA PHARMS AB AB AB MYLAN AB AB AB SANDOZ AB AB AB

3 - 301 (of 424)

20MG 40MG 80MG 20MG 40MG 80MG 20MG 40MG 80MG 20MG 40MG 80MG

N018063 005 N018063 001 N018063 002 A074229 A074229 A074255 A074172 A074172 A074172 A074501 A074501 A074501 001 002 001 001 002 003 001 002 003

Oct 28, 1986

Aug Aug Jan Oct Oct Oct Nov Nov Nov

30, 30, 24, 31, 31, 31, 09, 09, 09,

1996 1996 1996 1993 1993 1993 1995 1995 1995

NAFARELIN ACETATE
SPRAY, METERED; NASAL

SYNAREL

XX + GD SEARLE LLC

EQ 0.2MG BASE/SPRAY

N019886 001

Feb 13, 1990

NAFCILLIN SODIUM
INJECTABLE; INJECTION NAFCILLIN SODIUM ACIC FINE CHEMS AP EQ 1GM BASE AP EQ 2GM BASE IBI AP EQ 1GM BASE/VIAL AP EQ 2GM BASE/VIAL INSTITUTO BIOCHEMICO EQ 10GM BASE/VIAL AP AP + SANDOZ EQ 1GM BASE/VIAL AP + EQ 1GM BASE/VIAL AP + EQ 2GM BASE/VIAL AP + EQ 2GM BASE/VIAL AP + EQ 10GM BASE/VIAL NALLPEN IN PLASTIC CONTAINER EQ 20MG BASE/ML XX + BAXTER HLTHCARE EQ 2GM BASE/100ML XX +

A090560 A090560 A090002 A090002 A090005 A062527 A062732 A062527 A062732 A062527

001 002 001 002 001 002 001 003 002 004

Oct Oct Jun Jun Apr Aug Dec Aug Dec Aug

03, 03, 30, 30, 20, 02, 23, 02, 23, 02,

2011 2011 2011 2011 2011 1984 1986 1984 1986 1984

N050655 001 N050655 002

Oct 31, 1989 Oct 31, 1989

NAFTIFINE HYDROCHLORIDE

CREAM; TOPICAL

NAFTIN
XX + MERZ PHARMS
GEL; TOPICAL

NAFTIN
XX + MERZ PHARMS

1%

N019599 001

Feb 29, 1988

1%

N019356 001

Jun 18, 1990

NALBUPHINE HYDROCHLORIDE
INJECTABLE; INJECTION NALBUPHINE HYDROCHLORIDE + HOSPIRA 10MG/ML + 10MG/ML + 20MG/ML + 20MG/ML

AP AP AP AP

A070914 A070915 A070916 A070918

001 001 001 001

Feb Feb Feb Feb

03, 03, 03, 03,

1989 1989 1989 1989

NALOXONE HYDROCHLORIDE
INJECTABLE; INJECTION NALOXONE HYDROCHLORIDE AP + HOSPIRA

0.4MG/ML

A070172 001

Sep 24, 1986

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

NALOXONE HYDROCHLORIDE

INJECTABLE; INJECTION
NALOXONE HYDROCHLORIDE + HOSPIRA + + INTL MEDICATION +

3 - 302 (of 424)

AP AP AP AP AP

0.4MG/ML 0.4MG/ML 0.4MG/ML 0.4MG/ML 1MG/ML

A070254 A070256 A070257 A070639 A072076

001 001 001 001 001

Jan Jan Jan Sep Mar

07, 07, 07, 24, 24,

1987 1987 1987 1986 1988

NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE

TABLET; ORAL PENTAZOCINE AND NALOXONE HYDROCHLORIDE GAVIS PHARMS AB EQ 0.5MG BASE;EQ 50MG BASE PENTAZOCINE AND NALOXONE HYDROCHLORIDES RANBAXY AB EQ 0.5MG BASE;EQ 50MG BASE AB + WATSON LABS EQ 0.5MG BASE;EQ 50MG BASE

A075735 001 A075523 001 A074736 001

Jul 11, 2001 Mar 17, 2000 Jan 21, 1997

NALTREXONE
FOR SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR
VIVITROL
380MG/VIAL XX + ALKERMES

N021897 001

Apr 13, 2006

NALTREXONE HYDROCHLORIDE
TABLET; ORAL NALTREXONE HYDROCHLORIDE ACCORD HLTHCARE 50MG BARR 50MG ELITE LABS 50MG MALLINCKRODT 50MG SANDOZ 50MG REVIA + DURAMED 50MG NALTREXONE HYDROCHLORIDE MALLINCKRODT 25MG 100MG

AB AB AB AB AB AB XX XX

A091205 A074918 A075274 A076264 A075434

001 001 001 002 001

Aug May May Mar Mar

17, 08, 26, 22, 08,

2011 1998 1999 2002 2000

N018932 001 A076264 001 A076264 003

Nov 20, 1984 Mar 22, 2002 Mar 22, 2002

NANDROLONE DECANOATE
INJECTABLE; INJECTION
NANDROLONE DECANOATE
XX + PHARMAFORCE

200MG/ML

A091252 001

Aug 30, 2010

NAPHAZOLINE HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC ALBALON AT + ALLERGAN 0.1% NAPHAZOLINE HYDROCHLORIDE TAYLOR AT 0.1%

A080248 001 A083590 001

NAPROXEN
SUSPENSION; ORAL NAPROSYN AB + ROCHE PALO NAPROXEN ROXANE AB TABLET; ORAL NAPROSYN ROCHE PALO AB AB AB +

25MG/ML 25MG/ML

N018965 001 A074190 001

Mar 23, 1987 Mar 30, 1994

250MG 375MG 500MG

N017581 002 N017581 003 N017581 004

Apr 15, 1982

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

NAPROXEN
TABLET; ORAL NAPROXEN AMNEAL PHARMS NY AB AB AB AUROBINDO PHARMA USA AB AB AB DAVA PHARMS INC AB AB AB GLENMARK GENERICS AB AB AB INVAGEN PHARMS AB AB AB MARKSANS PHARMA AB AB AB MYLAN AB AB AB PERRIGO R AND D AB AB AB SANDOZ AB AB AB TEVA AB AB AB WATSON LABS AB AB AB WESTWARD AB AB AB ZYDUS PHARMS USA AB AB AB

3 - 303 (of 424)

250MG 375MG 500MG 250MG 375MG 500MG 250MG 375MG 500MG 250MG 375MG 500MG 250MG 375MG 500MG 250MG 375MG 500MG 250MG 375MG 500MG 250MG 375MG 500MG 250MG 375MG 500MG 250MG 375MG 500MG 250MG 375MG 500MG 250MG 375MG 500MG 250MG 375MG 500MG

A075927 A075927 A075927 A200429 A200429 A200429 A074410 A074410 A074410 A078250 A078250 A078250 A091305 A091305 A091305 A091416 A091416 A091416 A074121 A074121 A074121 A077339 A077339 A077339 A074140 A074140 A074140 A074201 A074201 A074201 A074457 A074457 A074457 A076494 A076494 A076494 A078620 A078620 A078620

001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003

Dec Dec Dec Nov Nov Nov Apr Apr Apr Mar Mar Mar Aug Aug Aug Feb Feb Feb Dec Dec Dec Apr Apr Apr Dec Dec Dec Dec Dec Dec May May May Jan Jan Jan Jun Jun Jun

18, 18, 18, 08, 08, 08, 28, 28, 28, 28, 28, 28, 24, 24, 24, 14, 14, 14, 21, 21, 21, 27, 27, 27, 21, 21, 21, 21, 21, 21, 31, 31, 31, 14, 14, 14, 07, 07, 07,

2001 2001 2001 2011 2011 2011 1995 1995 1995 2007 2007 2007 2011 2011 2011 2011 2011 2011 1993 1993 1993 2005 2005 2005 1993 1993 1993 1993 1993 1993 1995 1995 1995 2004 2004 2004 2007 2007 2007

TABLET, DELAYED RELEASE; ORAL EC-NAPROSYN AB + ROCHE PALO 375MG AB + 500MG NAPROXEN ALPHAPHARM AB 375MG AB 500MG INVAGEN PHARMS AB 375MG AB 500MG PLIVA AB 375MG AB 500MG SANDOZ AB 375MG AB 500MG TEVA AB 375MG AB 500MG

N020067 002 N020067 003 A075390 A075390 A091432 A091432 A075337 A075337 A075061 A075061 A075227 A075227 001 002 001 002 001 002 001 002 001 002

Oct 14, 1994 Oct 14, 1994 Apr Apr Sep Sep May May Feb Feb Jun Jun 19, 19, 19, 19, 26, 26, 18, 18, 30, 30, 2001 2001 2011 2011 1999 1999 1998 1998 1998 1998

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

NAPROXEN SODIUM
TABLET; ORAL ANAPROX ROCHE PALO AB ANAPROX DS AB + ROCHE PALO NAPROXEN SODIUM AMNEAL PHARMS NY AB AB AUROBINDO PHARMA LTD AB AB DR REDDYS LABS LTD AB AB GLENMARK GENERICS AB AB HIKMA AB AB TEVA AB AB WATSON LABS AB AB

3 - 304 (of 424)

EQ 250MG BASE EQ 500MG BASE EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ 250MG 500MG 250MG 500MG 250MG 500MG 250MG 500MG 250MG 500MG 250MG 500MG 250MG 500MG BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE

N018164 001 N018164 003 A078432 A078432 A200629 A200629 A078486 A078486 A078314 A078314 A074480 A074480 A074198 A074198 A074455 A074455 001 002 001 002 001 002 001 002 002 001 001 002 001 002 Sep 30, 1987 Apr Apr Oct Oct Jul Jul Apr Apr Feb May Dec Dec May May 25, 25, 31, 31, 26, 26, 27, 27, 18, 14, 21, 21, 31, 31, 2007 2007 2011 2011 2007 2007 2007 2007 1998 1996 1993 1993 1995 1995

TABLET, EXTENDED RELEASE; ORAL NAPRELAN STAT TRADE EQ 375MG BASE XX EQ 500MG BASE XX EQ 750MG BASE XX +

N020353 001 N020353 002 N020353 003

Jan 05, 1996 Jan 05, 1996 Jan 05, 1996

NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE

TABLET; ORAL

TREXIMET

XX + GLAXOSMITHKLINE

500MG;EQ 85MG BASE

N021926 001

Apr 15, 2008

NARATRIPTAN
TABLET; ORAL NARATRIPTAN APOTEX CORP AB AB SUN PHARM INDS LTD AB

EQ 1MG BASE EQ 2.5MG BASE EQ 2.5MG BASE

A091373 001 A091373 002 A091552 001

Apr 22, 2011 Apr 22, 2011 Feb 14, 2011

NARATRIPTAN HYDROCHLORIDE
TABLET; ORAL AMERGE GLAXOSMITHKLINE AB AB + NARATRIPTAN HERITAGE PHARMS INC AB AB PADDOCK LLC AB AB ROXANE AB AB SANDOZ AB AB TEVA PHARMS AB AB

EQ 1MG BASE EQ 2.5MG BASE EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ 1MG BASE 2.5MG BASE 1MG BASE 2.5MG BASE 1MG BASE 2.5MG BASE 1MG BASE 2.5MG BASE 1MG BASE 2.5MG BASE

N020763 002 N020763 001 A200502 A200502 A091326 A091326 A090381 A090381 A090288 A090288 A078751 A078751 001 002 001 002 001 002 001 002 001 002

Feb 10, 1998 Feb 10, 1998 Feb Feb Jul Jul Jul Jul Jul Jul Jul Jul 28, 28, 08, 08, 07, 07, 07, 07, 07, 07, 2011 2011 2010 2010 2010 2010 2010 2010 2010 2010

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

NATAMYCIN

SUSPENSION; OPHTHALMIC

NATACYN
XX + ALCON

3 - 305 (of 424)

5%

N050514 001

NATEGLINIDE
TABLET; ORAL NATEGLINIDE DR REDDYS LABS LTD AB AB PAR PHARM AB AB TEVA PHARMS AB AB WATSON LABS AB AB STARLIX NOVARTIS AB AB +

60MG 120MG 60MG 120MG 60MG 120MG 60MG 120MG 60MG 120MG

A077461 A077461 A077463 A077463 A077467 A077467 A077462 A077462

001 002 001 002 001 002 001 002

Sep Sep Sep Sep Sep Sep Mar Mar

09, 09, 09, 09, 09, 09, 30, 30,

2009 2009 2009 2009 2009 2009 2011 2011

N021204 001 N021204 002

Dec 22, 2000 Dec 22, 2000

NEBIVOLOL HYDROCHLORIDE
TABLET; ORAL BYSTOLIC FOREST LABS XX XX XX XX +

EQ EQ EQ EQ

2.5MG BASE 5MG BASE 10MG BASE 20MG BASE

N021742 N021742 N021742 N021742

002 003 004 005

Dec Dec Dec Oct

17, 17, 17, 08,

2007 2007 2007 2008

NEDOCROMIL SODIUM

SOLUTION/DROPS; OPHTHALMIC

ALOCRIL
XX + ALLERGAN 2%

N021009 001

Dec 08, 1999

NEFAZODONE HYDROCHLORIDE
TABLET; ORAL NEFAZODONE HYDROCHLORIDE RANBAXY AB 50MG AB 100MG AB 150MG AB 200MG AB 250MG TEVA AB 50MG AB 100MG AB 150MG AB 200MG AB + 250MG NEFAZODONE HYDROCHLORIDE BX DR REDDYS LABS INC 50MG BX 100MG BX 150MG BX 200MG BX 250MG

A076409 A076409 A076409 A076409 A076409 A076037 A076037 A076037 A076037 A076037 A076309 A076309 A076309 A076309 A076309

001 002 003 004 005 001 002 003 004 005 001 002 003 004 005

Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep

16, 16, 16, 16, 16, 16, 16, 16, 16, 16, 16, 16, 16, 16, 16,

2003 2003 2003 2003 2003 2003 2003 2003 2003 2003 2003 2003 2003 2003 2003

NELARABINE
INJECTABLE; IV (INFUSION)
ARRANON
XX + SMITHKLINE BEECHAM 250MG/50ML (5MG/ML)

N021877 001

Oct 28, 2005

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

NELFINAVIR MESYLATE

POWDER; ORAL

VIRACEPT
XX + AGOURON
TABLET; ORAL

VIRACEPT
XX + AGOURON XX +

3 - 306 (of 424)

EQ 50MG BASE/SCOOPFUL

N020778 001

Mar 14, 1997

EQ 250MG BASE EQ 625MG BASE

N020779 001 N021503 001

Mar 14, 1997 Apr 30, 2003

NEOMYCIN SULFATE

POWDER; FOR RX COMPOUNDING

NEO-RX
XX X GEN PHARMS 100%
SOLUTION; ORAL

NEO-FRADIN
XX + X GEN PHARMS TABLET; ORAL NEOMYCIN SULFATE OMAN PHARM PRODUCTS AA AA + TEVA X GEN PHARMS AA

A061579 001

EQ 87.5MG BASE/5ML

A065010 001

May 23, 2002

500MG 500MG 500MG

A065468 001 A060304 001 A065220 001

Mar 29, 2010 Jul 28, 2006

NEOMYCIN SULFATE; POLYMYXIN B SULFATE

SOLUTION; IRRIGATION NEOMYCIN AND POLYMYXIN B SULFATE WATSON LABS AT EQ 40MG BASE/ML;200,000 X GEN PHARMS AT EQ 40MG BASE/ML;200,000 AT EQ 40MG BASE/ML;200,000 NEOSPORIN G.U. IRRIGANT AT + MONARCH PHARMS EQ 40MG BASE/ML;200,000

UNITS/ML UNITS/ML UNITS/ML UNITS/ML

A062664 001 A065106 001 A065108 001 A060707 001

Apr 08, 1986 Jan 31, 2006 Jan 31, 2006

NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PREDNISOLONE ACETATE

SUSPENSION/DROPS; OPHTHALMIC

POLY-PRED
EQ 0.35% BASE;10,000 UNITS/ML;0.5% XX + ALLERGAN

N050081 002

NEPAFENAC
SUSPENSION/DROPS; OPHTHALMIC
NEVANAC
XX + ALCON PHARMS LTD 0.1%

N021862 001

Aug 19, 2005

NESIRITIDE RECOMBINANT

FOR SOLUTION; INTRAVENOUS

NATRECOR
1.5MG/VIAL XX + SCIOS

N020920 001

Aug 10, 2001

NEVIRAPINE

SUSPENSION; ORAL

VIRAMUNE
XX + BOEHRINGER INGELHEIM
TABLET; ORAL

VIRAMUNE
XX + BOEHRINGER INGELHEIM

50MG/5ML

N020933 001

Sep 11, 1998

200MG

N020636 001

Jun 21, 1996

TABLET, EXTENDED RELEASE; ORAL

VIRAMUNE XR
XX + BOEHRINGER INGELHEIM 400MG

N201152 001

Mar 25, 2011

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

NIACIN
TABLET; ORAL NIACIN WOCKHARDT AA NIACOR AA + UPSHER SMITH

3 - 307 (of 424)

500MG 500MG

A081134 001 A040378 001

Apr 28, 1992 May 03, 2000

TABLET, EXTENDED RELEASE; ORAL NIASPAN ABBOTT 500MG XX 750MG XX + 1GM XX +

N020381 002 N020381 003 N020381 004

Jul 28, 1997 Jul 28, 1997 Jul 28, 1997

NIACIN; SIMVASTATIN

TABLET, EXTENDED RELEASE; ORAL

SIMCOR
+ ABBOTT 500MG;20MG + 500MG;40MG + 750MG;20MG + 1GM;20MG + 1GM;40MG

XX XX XX XX XX

N022078 N022078 N022078 N022078 N022078

001 004 002 003 005

Feb Jul Feb Feb Jul

15, 28, 15, 15, 28,

2008 2010 2008 2008 2010

NICARDIPINE HYDROCHLORIDE
CAPSULE; ORAL CARDENE EKR THERAP 20MG + 30MG NICARDIPINE HYDROCHLORIDE BARR 20MG 30MG EPIC PHARMA 20MG 30MG MYLAN 20MG 30MG TEVA 20MG 30MG WATSON LABS 20MG 30MG

AB AB AB AB AB AB AB AB AB AB AB AB

N019488 001 N019488 002 A074439 A074439 A074928 A074928 A074642 A074642 A074540 A074540 A074670 A074670 001 002 001 002 001 002 001 002 001 002

Dec 21, 1988 Dec 21, 1988 Dec Dec Mar Mar Jul Jul Oct Oct Oct Oct 10, 10, 19, 19, 18, 18, 28, 28, 28, 28, 1996 1996 1998 1998 1996 1996 1996 1996 1996 1996

CAPSULE, EXTENDED RELEASE; ORAL

CARDENE SR
30MG XX + EKR THERAP 60MG XX + INJECTABLE; INJECTION CARDENE + EKR THERAP 25MG/10ML NICARDIPINE HYDROCHLORIDE BEDFORD 25MG/10ML BIONICHE PHARMA USA 25MG/10ML EXELA PHARMA SCIENCE 25MG/10ML NAVINTA LLC 25MG/10ML PHARMAFORCE 25MG/10ML SUN PHARMA GLOBAL 25MG/10ML WOCKHARDT 25MG/10ML

N020005 001 N020005 003

Feb 21, 1992 Feb 21, 1992

AP AP AP AP AP AP AP AP

(2.5MG/ML) (2.5MG/ML) (2.5MG/ML) (2.5MG/ML) (2.5MG/ML) (2.5MG/ML) (2.5MG/ML) (2.5MG/ML)

N019734 001 A078714 A090664 N022276 A090125 A090534 N078405 A090671 001 001 001 001 001 001 001

Jan 30, 1992 Dec Nov Jul Nov Nov Nov Nov 28, 17, 24, 17, 17, 17, 17, 2009 2009 2008 2009 2009 2009 2009

INJECTABLE; INTRAVENOUS

CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER
40MG/200ML (0.2MG/ML) XX + EKR THERAP CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER 20MG/200ML (0.1MG/ML) XX + EKR THERAP CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER 20MG/200ML (0.1MG/ML) XX + EKR THERAP

N019734 004 N019734 003 N019734 002

Nov 07, 2008 Jul 31, 2008 Jul 31, 2008

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

NICARDIPINE HYDROCHLORIDE
INJECTABLE; INTRAVENOUS

CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER

40MG/200ML (0.2MG/ML) XX + EKR THERAP

3 - 308 (of 424)

N019734 005

Nov 07, 2008

NICOTINE
INHALANT; ORAL

NICOTROL

XX + PHARMACIA AND UPJOHN SPRAY, METERED; NASAL

NICOTROL

XX + PFIZER INC

4MG/CARTRIDGE

N020714 001

May 02, 1997

0.5MG/SPRAY

N020385 001

Mar 22, 1996

NIFEDIPINE
CAPSULE; ORAL NIFEDIPINE ACTAVIS ELIZABETH CATALENT INTERGEL PHARM PROCARDIA + PFIZER NIFEDIPINE ACTAVIS ELIZABETH

AB AB AB AB XX

10MG 10MG 10MG 10MG 20MG ORAL 30MG 60MG 90MG 30MG 60MG 30MG 60MG 30MG 60MG 90MG 30MG 60MG 90MG 30MG 60MG 90MG 30MG 60MG 90MG 30MG 60MG 90MG 30MG 60MG 30MG 60MG 90MG

A072579 001 A073250 001 A072781 001 N018482 001 A072556 001

Jan 08, 1991 Oct 08, 1991 Jul 30, 1993

Sep 20, 1990

TABLET, EXTENDED RELEASE; ADALAT CC BAYER HLTHCARE AB1 AB1 + AB1 + AFEDITAB CR WATSON LABS AB1 AB1 NIFEDIPINE ACTAVIS AB1 AB1 MYLAN AB1 AB1 AB1 VALEANT INTL AB1 AB1 AB1 NIFEDIPINE MATRIX LABS LTD AB2 AB2 AB2 MYLAN AB2 AB2 AB2 OSMOTICA PHARM AB2 AB2 AB2 VALEANT INTL AB2 AB2 PROCARDIA XL PFIZER AB2 AB2 AB2 +

N020198 001 N020198 002 N020198 003 A075128 001 A075659 001 A077899 A077899 A201071 A201071 A201071 A075269 A075269 A076070 A090602 A090602 A090602 A090649 A090649 A090649 A077127 A077127 A077410 A075289 A075289 001 002 001 002 003 001 002 001 001 002 003 001 002 003 001 002 001 002 001

Apr 21, 1993 Apr 21, 1993 Apr 21, 1993 Mar 10, 2000 Oct 26, 2001 Dec Dec Dec Dec Dec Dec Dec Aug Sep Sep Sep Jun Jun Jun Nov Nov Oct Feb Sep 13, 13, 03, 03, 03, 04, 04, 16, 13, 13, 13, 21, 21, 21, 21, 21, 03, 06, 27, 2006 2006 2010 2010 2010 2000 2000 2002 2010 2010 2010 2010 2010 2010 2005 2005 2007 2001 2000

N019684 001 N019684 002 N019684 003

Sep 06, 1989 Sep 06, 1989 Sep 06, 1989

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

NILOTINIB HYDROCHLORIDE MONOHYDRATE
CAPSULE; ORAL TASIGNA NOVARTIS XX XX +

3 - 309 (of 424)

EQ 150MG BASE EQ 200MG BASE

N022068 002 N022068 001

Jun 17, 2010 Oct 29, 2007

NILUTAMIDE

TABLET; ORAL

NILANDRON
XX + SANOFI AVENTIS US

150MG

N020169 002

Apr 30, 1999

NIMODIPINE
CAPSULE; ORAL NIMODIPINE BANNER PHARMACAPS AB BARR LABS INC AB AB + SUN PHARM INDS INC

30MG 30MG 30MG

A076740 001 A077811 001 A077067 001

Jan 17, 2008 May 02, 2007 Apr 17, 2007

NISOLDIPINE
TABLET, EXTENDED RELEASE; ORAL NISOLDIPINE MYLAN AB 8.5MG AB 17MG AB 25.5MG AB 34MG SULAR AB + SHIONOGI INC 8.5MG AB + 17MG AB 25.5MG AB + 34MG NISOLDIPINE 20MG XX + MYLAN 30MG XX + 40MG XX +

A091001 A091001 A091001 A091001 N020356 N020356 N020356 N020356

001 002 003 004 008 007 006 005

Jan Jan Jan Jan Jan Jan Jan Jan

26, 26, 26, 26, 02, 02, 02, 02,

2011 2011 2011 2011 2008 2008 2008 2008

A079051 001 A079051 002 A079051 003

Jul 25, 2008 Jul 25, 2008 Jul 25, 2008

NITAZOXANIDE
FOR SUSPENSION; ORAL

ALINIA

XX + ROMARK TABLET; ORAL

ALINIA

XX + ROMARK

100MG/5ML

N021498 001

Nov 22, 2002

500MG

N021497 001

Jul 21, 2004

NITISINONE
CAPSULE; ORAL ORFADIN RARE DIS XX XX XX +

2MG 5MG 10MG

N021232 001 N021232 002 N021232 003

Jan 18, 2002 Jan 18, 2002 Jan 18, 2002

NITRIC OXIDE
GAS; INHALATION INOMAX INO XX XX +

100PPM 800PPM

N020845 002 N020845 003

Dec 23, 1999 Dec 23, 1999

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

NITROFURANTOIN
SUSPENSION; ORAL FURADANTIN AB + SHIONOGI INC NITROFURANTOIN AMNEAL PHARMS AB

3 - 310 (of 424)

25MG/5ML 25MG/5ML

N009175 001 A201679 001 May 11, 2011

NITROFURANTOIN, MACROCRYSTALLINE
CAPSULE; ORAL MACRODANTIN ALVOGEN AB AB AB + NITROFURANTOIN IVAX SUB TEVA PHARMS AB AB MYLAN AB AB WATSON LABS AB AB AB

25MG 50MG 100MG 50MG 100MG 50MG 100MG 25MG 50MG 100MG

N016620 003 N016620 001 N016620 002 A073671 A073652 A074967 A077025 A073696 A073696 A073696 001 001 001 001 001 002 003 Jan Jan Jul Aug Dec Dec Dec 28, 28, 09, 18, 31, 31, 31, 1993 1993 1997 2004 1992 1992 1992

NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE

CAPSULE; ORAL MACROBID + ALVOGEN 75MG;25MG NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) MYLAN 75MG;25MG RANBAXY 75MG;25MG SANDOZ 75MG;25MG

AB AB AB AB

N020064 001 A076648 001 A076951 001 A077066 001

Dec 24, 1991 Mar 22, 2004 Mar 30, 2005 Apr 05, 2005

NITROGLYCERIN
AEROSOL, METERED; SUBLINGUAL

NITROMIST

0.4MG/SPRAY XX + NOVADEL FILM, EXTENDED RELEASE; TRANSDERMAL MINITRAN GRACEWAY AB1 0.1MG/HR AB1 0.2MG/HR AB1 0.4MG/HR AB1 0.6MG/HR NITRO-DUR AB1 + KEY PHARMS 0.1MG/HR AB1 + 0.2MG/HR AB1 + 0.4MG/HR AB1 + 0.6MG/HR NITROGLYCERIN KREMERS URBAN PHARMS 0.2MG/HR AB1 AB1 0.4MG/HR NITROGLYCERIN HERCON LABS AB2 0.2MG/HR AB2 0.4MG/HR AB2 0.6MG/HR AB2 + MYLAN TECHNOLOGIES 0.2MG/HR AB2 + 0.4MG/HR AB2 + 0.6MG/HR NITRO-DUR 0.3MG/HR XX + KEY PHARMS 0.8MG/HR XX +

N021780 001

Nov 02, 2006

A089771 A089772 A089773 A089774 N020145 N020145 N020145 N020145

001 001 001 001 001 002 004 005

Aug Aug Aug Aug Apr Apr Apr Apr

30, 30, 30, 30, 04, 04, 04, 04,

1996 1996 1996 1996 1995 1995 1995 1995

A075115 001 A075115 002 A089884 A089885 A089886 A074559 A074559 A074559 001 001 001 003 002 001

Aug 10, 2004 Aug 10, 2004 Oct Oct Oct Aug Aug Aug 30, 30, 30, 30, 30, 30, 1998 1998 1998 1996 1996 1996

N020145 003 N020145 006

Apr 04, 1995 Apr 04, 1995

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

NITROGLYCERIN
FILM, EXTENDED RELEASE; TRANSDERMAL

NITROGLYCERIN

0.1MG/HR XX + MYLAN TECHNOLOGIES INJECTABLE; INJECTION NITROGLYCERIN + HOSPIRA 5MG/ML + LUITPOLD 5MG/ML NITROGLYCERIN IN DEXTROSE 5% + BAXTER HLTHCARE 10MG/100ML + 20MG/100ML + 40MG/100ML HOSPIRA 10MG/100ML 20MG/100ML 40MG/100ML

3 - 311 (of 424)

A074559 004

Feb 06, 1998

AP AP AP AP AP AP AP AP

N018531 001 A072034 001 N019970 N019970 N019970 A071846 A071847 A071848 001 002 003 001 001 001

May 24, 1988 Dec Dec Dec Aug Aug Aug 29, 29, 29, 31, 31, 31, 1989 1989 1989 1990 1990 1990

OINTMENT; INTRA-ANAL

RECTIV

XX + PROSTRAKAN INC OINTMENT; TRANSDERMAL

NITROGLYCERIN

XX + FOUGERA

0.4%

N021359 001

Jun 21, 2011

2%

A087355 001

Jul 08, 1988

SPRAY, METERED; SUBLINGUAL

NITROLINGUAL PUMPSPRAY

0.4MG/SPRAY XX + POHL BOSKAMP TABLET; SUBLINGUAL NITROSTAT PFIZER PHARMS XX XX XX +

N018705 002

Jan 10, 1997

0.3MG 0.4MG 0.6MG

N021134 001 N021134 002 N021134 003

May 01, 2000 May 01, 2000 May 01, 2000

NIZATIDINE
CAPSULE; ORAL AXID SMITHKLINE BEECHAM AB AB + NIZATIDINE APOTEX AB AB DR REDDYS LABS LTD AB AB GLENMARK GENERICS AB AB MYLAN AB AB AB AB SANDOZ AB AB TEVA AB AB WATSON LABS AB AB SOLUTION; ORAL AXID AA + BRAINTREE NIZATIDINE AMNEAL PHARMS AA

150MG 300MG 150MG 300MG 150MG 300MG 150MG 300MG 150MG 150MG 300MG 300MG 150MG 300MG 150MG 300MG 150MG 300MG

N019508 001 N019508 002 A076383 A076383 A077314 A077314 A090618 A090618 A075806 A075934 A075806 A075934 A076178 A076178 A075668 A075668 A075616 A075616 001 002 001 002 001 002 001 001 002 002 001 002 001 002 001 002

Apr 12, 1988 Apr 12, 1988 Jan Jan Sep Sep Jul Jul Jul Jul Jul Jul Jul Jul Sep Sep Jul Jul 23, 23, 15, 15, 15, 15, 05, 09, 05, 09, 05, 05, 12, 12, 09, 09, 2003 2003 2005 2005 2011 2011 2002 2002 2002 2002 2002 2002 2002 2002 2002 2002

15MG/ML 15MG/ML

N021494 001 A090576 001

May 25, 2004 Nov 18, 2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

NOREPINEPHRINE BITARTRATE
INJECTABLE; INJECTION LEVOPHED AP + HOSPIRA EQ 1MG BASE/ML NOREPINEPHRINE BITARTRATE BEDFORD AP EQ 1MG BASE/ML TEVA PARENTERAL AP EQ 1MG BASE/ML

3 - 312 (of 424)

N007513 001 A040462 001 A040455 001 Oct 31, 2003 Mar 03, 2003

NORETHINDRONE
TABLET; ORAL-28 CAMILA BARR AB1 HEATHER GLENMARK GENERICS AB1 NORETHINDRONE LUPIN LTD AB1 NOR-QD AB1 + WATSON LABS (UTAH) ERRIN BARR AB2 MICRONOR AB2 + JANSSEN PHARMS NORETHIDRONE GLENMARK GENERICS AB2

0.35MG 0.35MG 0.35MG 0.35MG 0.35MG 0.35MG 0.35MG

A076177 001 A090454 001 A091325 001 N017060 001 A076225 001 N016954 001 A091209 001

Oct 21, 2002 Apr 23, 2010 Sep 19, 2011

Oct 21, 2002

Jul 21, 2010

NORETHINDRONE ACETATE
TABLET; ORAL AYGESTIN AB + DURAMED RES NORETHINDRONE ACETATE BARR AB GLENMARK GENERICS AB

5MG 5MG 5MG

N018405 001 A075951 001 A091090 001

Apr 21, 1982 May 25, 2001 Jul 21, 2010

NORFLOXACIN
TABLET; ORAL
NOROXIN
XX + MERCK

400MG

N019384 002

Oct 31, 1986

NORTRIPTYLINE HYDROCHLORIDE
CAPSULE; ORAL NORTRIPTYLINE HYDROCHLORIDE MYLAN AB EQ 10MG AB EQ 25MG AB EQ 50MG AB EQ 75MG TARO AB EQ 10MG AB EQ 25MG AB EQ 50MG AB EQ 75MG TEVA AB EQ 10MG AB EQ 25MG AB EQ 50MG AB EQ 75MG WATSON LABS AB EQ 10MG AB EQ 25MG AB EQ 50MG AB EQ 75MG PAMELOR MALLINCKRODT LLC AB EQ 10MG AB EQ 25MG

BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE

A074234 A074234 A074234 A074234 A075520 A075520 A075520 A075520 A074132 A074132 A074132 A074132 A073553 A073554 A073555 A073556

001 002 003 004 004 003 001 002 001 002 003 004 001 001 001 001

Jul Jul Jul Jul May May May May Mar Mar Mar Mar Mar Mar Mar Mar

26, 26, 26, 26, 08, 08, 08, 08, 27, 27, 27, 27, 30, 30, 30, 30,

1993 1993 1993 1993 2000 2000 2000 2000 1995 1995 1995 1995 1992 1992 1992 1992

N018013 001 N018013 002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

NORTRIPTYLINE HYDROCHLORIDE
CAPSULE; ORAL PAMELOR MALLINCKRODT LLC AB AB +

3 - 313 (of 424)

EQ 50MG BASE EQ 75MG BASE

N018013 004 N018013 003

SOLUTION; ORAL AVENTYL HYDROCHLORIDE AA + RANBAXY EQ 10MG BASE/5ML NORTRIPTYLINE HYDROCHLORIDE PHARM ASSOC AA EQ 10MG BASE/5ML TARO AA EQ 10MG BASE/5ML

N014685 001 A075606 001 A077965 001 Aug 28, 2000 Jun 20, 2006

NYSTATIN
CREAM; TOPICAL NYSTATIN ACTAVIS MID ATLANTIC ALTANA PERRIGO NEW YORK TARO VINTAGE

AT AT AT AT AT

100,000 100,000 100,000 100,000 100,000

UNITS/GM UNITS/GM UNITS/GM UNITS/GM UNITS/GM

A062949 A062129 A062225 A064022 A065315

001 001 001 001 001

Jun 13, 1988

Jan 29, 1993 May 31, 2006

OINTMENT; TOPICAL NYSTATIN ACTAVIS MID ATLANTIC AT AT + ALTANA PERRIGO NEW YORK AT POWDER; TOPICAL NYSTATIN + COASTAL PHARMS NESHER PHARMS PAR PHARM UPSHER SMITH X GEN PHARMS NYSTOP PADDOCK LLC SUSPENSION; ORAL NILSTAT + GLENMARK GENERICS NYSTATIN ACTAVIS MID ATLANTIC FOUGERA HI TECH PHARMA TARO VINTAGE PHARMS VISTAPHARM + WOCKHARDT

100,000 UNITS/GM 100,000 UNITS/GM 100,000 UNITS/GM

A062840 001 A062124 002 A062472 001

Nov 13, 1987 Sep 23, 1982 Feb 13, 1984

AT AT AT AT AT AT

100,000 100,000 100,000 100,000 100,000

UNITS/GM UNITS/GM UNITS/GM UNITS/GM UNITS/GM

A065203 A065321 A065138 A065183 A065175

001 001 001 001 001

Jul Aug Jul May Dec

15, 18, 23, 03, 17,

2004 2006 2004 2005 2004

100,000 UNITS/GM

A064118 001

Aug 16, 1996

AA AA AA AA AA AA AA AA AA

100,000 UNITS/ML 100,000 100,000 100,000 100,000 100,000 100,000 100,000 100,000 UNITS/ML UNITS/ML UNITS/ML UNITS/ML UNITS/ML UNITS/ML UNITS/ML UNITS/ML

N050299 001 A062349 A062517 A064042 A062876 A065148 A064142 A065422 A062512 001 001 001 001 001 001 001 001 Jul Jun Feb Feb Jun Jun Mar Oct 14, 07, 28, 29, 28, 25, 07, 29, 1982 1984 1994 1988 2005 1998 2011 1984

TABLET; ORAL NYSTATIN MUTUAL PHARM AA AA + TEVA TABLET; VAGINAL

NYSTATIN
XX + ODYSSEY PHARMS

500,000 UNITS 500,000 UNITS

A062838 001 A062506 001

Dec 22, 1988 Jan 16, 1984

100,000 UNITS

A062615 001

Oct 17, 1985

NYSTATIN; TRIAMCINOLONE ACETONIDE

CREAM; TOPICAL NYSTATIN AND TRIAMCINOLONE ACETONIDE FOUGERA AT 100,000 UNITS/GM;0.1% AT + TARO 100,000 UNITS/GM;0.1%

A062599 001 A062364 001

Oct 08, 1985 Dec 22, 1987

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

NYSTATIN; TRIAMCINOLONE ACETONIDE
OINTMENT; TOPICAL NYSTATIN AND TRIAMCINOLONE ACETONIDE FOUGERA AT 100,000 UNITS/GM;0.1% AT + TARO 100,000 UNITS/GM;0.1%

3 - 314 (of 424)

A062602 001 A063305 001

Oct 09, 1985 Mar 29, 1993

OCTREOTIDE ACETATE
INJECTABLE; INJECTION OCTREOTIDE ACETATE APP PHARMS AP EQ 0.2MG BASE/ML AP EQ 1MG BASE/ML AP + BEDFORD EQ 0.2MG BASE/ML AP + EQ 1MG BASE/ML SUN PHARM INDS AP EQ 0.05MG BASE/ML AP EQ 0.05MG BASE/ML AP EQ 0.1MG BASE/ML AP EQ 0.1MG BASE/ML AP EQ 0.2MG BASE/ML AP EQ 0.2MG BASE/ML AP EQ 0.5MG BASE/ML AP EQ 0.5MG BASE/ML AP EQ 1MG BASE/ML AP EQ 1MG BASE/ML TEVA PARENTERAL AP EQ 0.05MG BASE/ML AP EQ 0.1MG BASE/ML AP EQ 0.2MG BASE/ML AP EQ 0.5MG BASE/ML AP EQ 1MG BASE/ML WOCKHARDT USA AP EQ 0.2MG BASE/ML AP EQ 1MG BASE/ML OCTREOTIDE ACETATE (PRESERVATIVE FREE) APP PHARMS AP EQ 0.05MG BASE/ML AP EQ 0.1MG BASE/ML AP EQ 0.5MG BASE/ML AP + BEDFORD EQ 0.05MG BASE/ML AP + EQ 0.1MG BASE/ML AP + EQ 0.5MG BASE/ML MYLAN INSTITUTIONAL AP EQ 0.05MG BASE/ML AP EQ 0.1MG BASE/ML AP EQ 0.5MG BASE/ML WOCKHARDT USA AP EQ 0.05MG BASE/ML AP EQ 0.1MG BASE/ML AP EQ 0.5MG BASE/ML SANDOSTATIN AP + NOVARTIS EQ 0.05MG BASE/ML AP + EQ 0.1MG BASE/ML AP + EQ 0.2MG BASE/ML AP + EQ 0.5MG BASE/ML AP + EQ 1MG BASE/ML SANDOSTATIN LAR NOVARTIS EQ 10MG BASE/VIAL XX EQ 20MG BASE/VIAL XX EQ 30MG BASE/VIAL XX +

A077450 A077450 A076330 A076330 A077329 A077372 A077329 A077372 A077330 A077373 A077329 A077372 A077331 A077373 A075957 A075957 A075959 A075957 A075959 A090986 A090986 A077457 A077457 A077457 A076313 A076313 A076313 A079198 A079198 A079198 A090985 A090985 A090985 N019667 N019667 N019667 N019667 N019667

001 002 001 002 001 001 002 002 001 001 003 003 001 002 001 002 001 003 002 001 002 001 002 003 001 003 002 001 002 003 001 002 003 001 002 004 003 005

Feb Feb Apr Apr Mar Aug Mar Aug Mar Aug Mar Aug Mar Aug Oct Oct Nov Oct Nov May May Feb Feb Feb Mar Mar Mar Feb Feb Feb May May May Oct Oct Jun Oct Jun

10, 10, 08, 08, 04, 14, 04, 14, 04, 14, 04, 14, 04, 14, 03, 03, 21, 03, 21, 11, 11, 10, 10, 10, 28, 28, 28, 10, 10, 10, 11, 11, 11, 21, 21, 12, 21, 12,

2006 2006 2005 2005 2008 2007 2008 2007 2008 2007 2008 2007 2008 2007 2005 2005 2005 2005 2005 2011 2011 2006 2006 2006 2005 2005 2005 2011 2011 2011 2011 2011 2011 1988 1988 1991 1988 1991

N021008 001 N021008 002 N021008 003

Nov 25, 1998 Nov 25, 1998 Nov 25, 1998

OFLOXACIN
SOLUTION/DROPS; OPHTHALMIC OCUFLOX AT + ALLERGAN 0.3% OFLOXACIN AKORN AT 0.3%

N019921 001 A076407 001

Jul 30, 1993 Apr 15, 2008

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

OFLOXACIN
SOLUTION/DROPS; OPHTHALMIC OFLOXACIN ALCON PHARMS LTD 0.3% BAUSCH AND LOMB 0.3% FDC LTD 0.3% FERA PHARMS 0.3% HI TECH PHARMA 0.3% NOVEX 0.3% SANDOZ 0.3% SOLUTION/DROPS; OTIC FLOXIN OTIC + DAIICHI OFLOXACIN ALCON PHARMS LTD APOTEX INC BAUSCH AND LOMB FERA PHARMS HI TECH PHARMA

3 - 315 (of 424)

AT AT AT AT AT AT AT

A076231 A076622 A078559 A076830 A076615 A076513 A076848

001 001 001 001 001 001 001

May May Feb Aug May May Nov

14, 14, 25, 31, 14, 14, 25,

2004 2004 2009 2004 2004 2004 2008

AT AT AT AT AT AT

0.3% 0.3% 0.3% 0.3% 0.3% 0.3%

N020799 001 A078222 A076527 A076128 A090395 A076616 001 001 001 001 001

Dec 16, 1997 Mar Sep Mar Aug Mar 17, 28, 17, 11, 17, 2008 2007 2008 2009 2008

TABLET; ORAL OFLOXACIN DR REDDYS LABS LTD AB AB AB RANBAXY AB AB AB TEVA AB AB AB +

200MG 300MG 400MG 200MG 300MG 400MG 200MG 300MG 400MG

A077098 A077098 A077098 A076220 A076220 A076220 A076182 A076182 A076182

001 002 003 001 002 003 001 002 003

Feb Feb Feb Sep Sep Sep Sep Sep Sep

10, 10, 10, 02, 02, 02, 02, 02, 02,

2006 2006 2006 2003 2003 2003 2003 2003 2003

OLANZAPINE
INJECTABLE; INTRAMUSCULAR OLANZAPINE INNOPHARMA LLC AP 10MG/VIAL ZYPREXA AP + LILLY 10MG/VIAL TABLET; ORAL OLANZAPINE DR REDDYS LABS LTD AB TEVA PHARMS AB AB AB AB AB ZYPREXA LILLY AB AB + AB AB AB AB

A201588 001 N021253 001

Oct 24, 2011 Mar 29, 2004

20MG 2.5MG 5MG 7.5MG 10MG 15MG 2.5MG 5MG 7.5MG 10MG 15MG 20MG

A076133 A076000 A076000 A076000 A076000 A076000 N020592 N020592 N020592 N020592 N020592 N020592

002 001 002 003 004 005 001 002 003 004 005 006

Oct Oct Oct Oct Oct Oct Sep Sep Sep Sep Sep Sep

24, 24, 24, 24, 24, 24, 30, 30, 30, 30, 09, 09,

2011 2011 2011 2011 2011 2011 1996 1996 1996 1996 1997 1997

TABLET, ORALLY DISINTEGRATING; ORAL OLANZAPINE APOTEX INC AB 5MG AB 10MG AB 15MG AB 20MG DR REDDYS LABS LTD AB 5MG

A091265 A091265 A091265 A091265 A076534

001 002 003 004 001

Oct Oct Oct Oct Oct

24, 24, 24, 24, 24,

2011 2011 2011 2011 2011

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

OLANZAPINE
TABLET, ORALLY DISINTEGRATING; ORAL OLANZAPINE DR REDDYS LABS LTD 10MG 15MG 20MG PAR PHARM 5MG 10MG 15MG 20MG TORRENT PHARMS LLC 5MG 10MG 15MG 20MG ZYPREXA ZYDIS + LILLY 5MG 10MG 15MG 20MG

3 - 316 (of 424)

AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB

A076534 A076534 A076534 A078109 A078109 A078109 A078109 A091415 A091415 A091415 A091415 N021086 N021086 N021086 N021086

002 003 004 001 002 003 004 001 002 003 004 001 002 003 004

Oct Oct Oct Oct Oct Oct Oct Oct Oct Oct Oct Apr Apr Apr Apr

24, 24, 24, 24, 24, 24, 24, 25, 25, 25, 25, 06, 06, 06, 06,

2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2000 2000 2000 2000

OLANZAPINE PAMOATE
SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR ZYPREXA RELPREVV ELI LILLY CO EQ 210MG BASE/VIAL XX EQ 300MG BASE/VIAL XX EQ 405MG BASE/VIAL XX +

N022173 001 N022173 002 N022173 003

Dec 11, 2009 Dec 11, 2009 Dec 11, 2009

OLMESARTAN MEDOXOMIL
TABLET; ORAL BENICAR XX DAIICHI SANKYO XX XX +

5MG 20MG 40MG

N021286 001 N021286 003 N021286 004

Apr 25, 2002 Apr 25, 2002 Apr 25, 2002

OLOPATADINE HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC
PATADAY
XX + ALCON PHARMS LTD EQ 0.2% BASE PATANOL XX + ALCON EQ 0.1% BASE SPRAY, METERED; NASAL

PATANASE

XX + ALCON PHARMS LTD

N021545 001 N020688 001

Dec 22, 2004 Dec 18, 1996

0.665MG/SPRAY

N021861 001

Apr 15, 2008

OLSALAZINE SODIUM
CAPSULE; ORAL

DIPENTUM

XX + MEDA PHARMS

250MG

N019715 001

Jul 31, 1990

OMEGA-3-ACID ETHYL ESTERS

CAPSULE; ORAL

LOVAZA

XX + SMITHKLINE BEECHAM

1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS

N021654 001

Nov 10, 2004

OMEPRAZOLE
CAPSULE, DELAYED REL PELLETS; ORAL OMEPRAZOLE APOTEX AB 10MG

A076048 001

Oct 22, 2007

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

OMEPRAZOLE
CAPSULE, DELAYED REL PELLETS; ORAL OMEPRAZOLE APOTEX AB 20MG AB 40MG DR REDDYS LABS AB 40MG DR REDDYS LABS LTD AB 10MG AB 10MG AB 20MG AB 20MG AB 40MG IMPAX LABS AB 10MG AB 20MG AB 40MG KREMERS URBAN PHARMS 10MG AB AB 20MG AB 40MG LEK PHARMS AB 10MG AB 20MG MYLAN AB 10MG AB 20MG AB 40MG SANDOZ AB 40MG WATSON LABS FLORIDA AB 10MG AB 20MG AB 40MG PRILOSEC ASTRAZENECA AB 10MG AB + 20MG AB + 40MG

3 - 317 (of 424)

A076048 A076048 A078490 A075576 A078693 A075576 A078693 A075576 A075785 A075785 A075785 A075410 A075410 A075410 A075757 A075757 A075876 A075876 A075876 A076515 A075347 A075347 A075347

002 003 001 003 001 002 002 001 001 002 003 001 002 003 001 002 001 002 003 001 001 002 003

Oct Jan Apr Oct Mar Oct Mar Jan Oct Oct Jan Nov Nov Jan Jan Jan May May Jan Jan May May May

22, 21, 17, 22, 16, 22, 16, 21, 22, 22, 21, 01, 01, 23, 28, 28, 29, 29, 21, 21, 30, 30, 30,

2007 2009 2009 2007 2009 2007 2009 2009 2007 2007 2009 2002 2002 2009 2003 2003 2003 2003 2009 2009 2008 2008 2008

N019810 003 N019810 001 N019810 002

Oct 05, 1995 Sep 14, 1989 Jan 15, 1998

OMEPRAZOLE MAGNESIUM
FOR SUSPENSION, DELAYED RELEASE; ORAL PRILOSEC ASTRAZENECA EQ 2.5MG BASE/PACKET XX EQ 10MG BASE/PACKET XX +

N022056 001 N022056 002

Mar 20, 2008 Mar 20, 2008

OMEPRAZOLE; SODIUM BICARBONATE

CAPSULE; ORAL OMEPRAZOLE AND SODIUM BICARBONATE PAR PHARM AB 20MG;1.1GM AB 40MG;1.1GM ZEGERID SANTARUS AB 20MG;1.1GM AB + 40MG;1.1GM FOR SUSPENSION; ORAL ZEGERID SANTARUS XX XX +

A078966 001 A078966 002 N021849 001 N021849 002

May 25, 2010 May 25, 2010 Feb 27, 2006 Feb 27, 2006

20MG/PACKET;1.68GM/PACKET 40MG/PACKET;1.68GM/PACKET

N021636 001 N021636 002

Jun 15, 2004 Dec 21, 2004

ONDANSETRON
FILM; ORAL ZUPLENZ MONOSOL RX LLC XX XX +

4MG 8MG

N022524 001 N022524 002

Jul 02, 2010 Jul 02, 2010

TABLET, ORALLY DISINTEGRATING; ORAL ONDANSETRON AUROBINDO PHARMA AB 4MG AB 8MG

A090469 001 A090469 002

Apr 12, 2010 Apr 12, 2010

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

ONDANSETRON
TABLET, ORALLY DISINTEGRATING; ORAL ONDANSETRON BARR AB 4MG AB 8MG GLENMARK GENERICS AB 4MG AB 8MG MYLAN AB 4MG AB 8MG NESHER PHARMS AB 4MG AB 8MG PAR PHARM AB 4MG AB 8MG RANBAXY AB 4MG AB 8MG SANDOZ AB 4MG AB 8MG SUN PHARM INDS AB 4MG AB 8MG TEVA AB 4MG AB 8MG ZOFRAN ODT GLAXOSMITHKLINE AB 4MG AB + 8MG ONDANSETRON PAR PHARM 16MG XX 24MG XX

3 - 318 (of 424)

A076693 A076693 A078152 A078152 A078139 A078139 A077717 A077717 A076506 A076506 A078602 A078602 A078050 A078050 A077557 A077557 A076810 A076810

001 002 001 002 001 002 001 002 001 002 001 002 001 002 001 002 001 002

Jun Jun Jun Jun Jun Jun Jun Jun Dec Dec Feb Feb Aug Aug Aug Aug Jun Jun

25, 25, 27, 27, 25, 25, 25, 25, 26, 26, 24, 24, 13, 13, 02, 02, 25, 25,

2007 2007 2007 2007 2007 2007 2007 2007 2006 2006 2011 2011 2007 2007 2007 2007 2007 2007

N020781 001 N020781 002 A077406 001 A077406 002

Jan 27, 1999 Jan 27, 1999 Dec 26, 2006 Dec 26, 2006

ONDANSETRON HYDROCHLORIDE
INJECTABLE; INJECTION ONDANSETRON HYDROCHLORIDE APOTEX EQ 2MG BASE/ML A077368 APP PHARMS EQ 2MG BASE/ML A076974 BAXTER HLTHCARE EQ 2MG BASE/ML A077365 BEDFORD EQ 2MG BASE/ML A076967 EMCURE PHARMS EQ 2MG BASE/ML A090424 GLAND PHARMA LTD EQ 2MG BASE/ML A079224 HIKMA FARMACEUTICA EQ 2MG BASE/ML A076781 HOSPIRA EQ 2MG BASE/ML A077473 EQ 2MG BASE/ML A077840 LANNETT EQ 2MG BASE/ML A090116 EQ 2MG BASE/ML A090883 LUITPOLD EQ 2MG BASE/ML A077582 EQ 2MG BASE/ML A079039 PFIZER EQ 2MG BASE/ML A078257 PLIVA HRVATSKA DOO EQ 2MG BASE/ML A077544 SANDOZ EQ 2MG BASE/ML A077430 SPECTRUM PHARMS EQ 2MG BASE/ML A078180 SUN PHARM INDS (IN) EQ 2MG BASE/ML A077172 TEVA EQ 2MG BASE/ML A076876 WOCKHARDT EQ 2MG BASE/ML A077577 ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER BEDFORD LABS EQ 0.64MG BASE/ML A078291 CLARIS LIFESCIENCES EQ 0.64MG BASE/ML A078308 + HOSPIRA EQ 0.64MG BASE/ML A077348 TEVA PHARMS EQ 0.64MG BASE/ML A077480 ONDANSETRON HYDROCHLORIDE AND SODIUM CHLORIDE IN PLASTIC CONTAINER + BAXTER HLTHCARE EQ 0.64MG BASE/ML N021915 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE APOTEX INC EQ 2MG BASE/ML A077343

AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP

001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 002 001

Dec Dec Dec Dec Apr Sep Dec Dec Jan Apr Aug Dec Nov Apr Dec Jun Mar Dec Nov Dec Apr Mar Feb Nov

26, 26, 26, 26, 16, 25, 26, 26, 19, 14, 05, 26, 18, 23, 26, 27, 26, 26, 22, 26, 13, 17, 01, 22,

2006 2006 2006 2006 2010 2009 2006 2006 2007 2010 2010 2006 2008 2008 2006 2007 2007 2006 2006 2006 2009 2008 2007 2006

Dec 27, 2006 Dec 26, 2006

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

ONDANSETRON HYDROCHLORIDE
INJECTABLE; INJECTION ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE APP PHARMS EQ 2MG BASE/ML BAXTER HLTHCARE EQ 2MG BASE/ML BEDFORD LABS EQ 2MG BASE/ML HIKMA FARMACEUTICA EQ 2MG BASE/ML HOSPIRA EQ 2MG BASE/ML LUITPOLD EQ 2MG BASE/ML EQ 2MG BASE/ML PFIZER EQ 2MG BASE/ML SANDOZ EQ 2MG BASE/ML SUN PHARM INDS LTD EQ 2MG BASE/ML TARO PHARMS IRELAND EQ 2MG BASE/ML TEVA EQ 2MG BASE/ML WOCKHARDT EQ 2MG BASE/ML ZOFRAN + GLAXOSMITHKLINE EQ 2MG BASE/ML ZOFRAN PRESERVATIVE FREE + GLAXOSMITHKLINE EQ 2MG BASE/ML SOLUTION; ORAL ONDANSETRON HYDROCHLORIDE AMNEAL PHARMS EQ APOTEX EQ AUROBINDO PHARMA EQ ROXANE EQ SILARX EQ TARO EQ ZOFRAN + GLAXOSMITHKLINE EQ

3 - 319 (of 424)

AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP

A076972 A077541 A077011 A076780 A077548 A077387 A079032 A078244 A077551 A077173 A078014 A076759 A077716

001 001 001 001 001 001 001 001 001 001 001 001 001

Dec Dec Dec Dec Dec Dec Nov Apr Jun Dec Mar Nov Dec

26, 26, 26, 26, 26, 26, 18, 23, 27, 26, 21, 22, 26,

2006 2006 2006 2006 2006 2006 2008 2008 2007 2006 2008 2006 2006

N020007 001 N020007 003

Jan 04, 1991 Dec 10, 1993

AA AA AA AA AA AA AA

4MG 4MG 4MG 4MG 4MG 4MG

BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML

A091483 A078127 A078776 A076960 A091342 A077009

001 001 001 001 001 001

Jan Jun Nov Dec Jan Nov

31, 25, 28, 26, 27, 30,

2011 2007 2007 2006 2011 2007

4MG BASE/5ML

N020605 001

Jan 24, 1997

TABLET; ORAL ONDANSETRON HYDROCHLORIDE APOTEX AB EQ AB EQ AUROBINDO PHARMA AB EQ AB EQ AB EQ DR REDDYS LABS LTD AB EQ AB EQ AB EQ GLENMARK GENERICS AB EQ AB EQ AB EQ MYLAN AB EQ AB EQ AB EQ NATCO PHARMA LTD AB EQ AB EQ PAR PHARM AB EQ AB EQ AB EQ PLIVA HRVATSKA DOO AB EQ AB EQ AB EQ SANDOZ AB EQ AB EQ AB EQ SUN PHARM INDS (IN) AB EQ AB EQ TARO AB EQ

4MG BASE 8MG BASE 4MG BASE 8MG BASE 24MG BASE 4MG BASE 8MG BASE 24MG BASE 4MG BASE 8MG BASE 24MG BASE 4MG BASE 8MG BASE 24MG BASE 4MG BASE 8MG BASE 4MG BASE 8MG BASE 24MG BASE 4MG BASE 8MG BASE 24MG BASE 4MG BASE 8MG BASE 24MG BASE 4MG BASE 8MG BASE 4MG BASE

A077306 A077306 A078539 A078539 A078539 A076183 A076183 A076183 A077535 A077535 A077535 A076930 A076930 A076930 A077851 A077851 A077303 A077303 A077303 A077112 A077112 A077112 A077517 A077517 A077517 A077050 A077050 A077729

001 002 001 002 003 003 002 001 001 002 003 001 002 004 001 002 001 002 004 001 002 003 001 002 003 001 002 001

Jun Jun Jul Jul Jul Dec Dec Dec Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Mar

25, 25, 31, 31, 31, 26, 26, 26, 25, 25, 25, 25, 25, 25, 25, 25, 25, 25, 25, 25, 25, 25, 25, 25, 25, 25, 25, 28,

2007 2007 2007 2007 2007 2006 2006 2006 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2011

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

ONDANSETRON HYDROCHLORIDE
TABLET; ORAL ONDANSETRON HYDROCHLORIDE TARO EQ AB EQ AB TEVA EQ AB EQ AB EQ AB WEST WARD EQ AB EQ AB EQ AB ZOFRAN GLAXOSMITHKLINE EQ AB AB EQ AB + EQ ONDANSETRON HYDROCHLORIDE DR REDDYS LABS LTD EQ XX

3 - 320 (of 424)

8MG BASE 24MG BASE 4MG BASE 8MG BASE 24MG BASE 4MG BASE 8MG BASE 24MG BASE 4MG BASE 8MG BASE 24MG BASE 16MG BASE

A077729 A077729 A076252 A076252 A076252 A077545 A077545 A077545

002 003 001 002 003 001 002 003

Mar Mar Jun Jun Jun Sep Sep Sep

28, 28, 25, 25, 25, 06, 06, 06,

2011 2011 2007 2007 2007 2007 2007 2007

N020103 001 N020103 002 N020103 003 A076559 001

Dec 31, 1992 Dec 31, 1992 Aug 27, 1999 Dec 26, 2006

ORLISTAT
CAPSULE; ORAL
XENICAL
XX + HOFFMANN LA ROCHE

120MG

N020766 001

Apr 23, 1999

ORPHENADRINE CITRATE
INJECTABLE; INJECTION NORFLEX + MEDICIS ORPHENADRINE CITRATE AKORN BEDFORD LABS SAGENT PHARMS WATSON LABS TABLET, EXTENDED RELEASE; ORPHENADRINE CITRATE GAVIS PHARMS IMPAX PHARMS KIEL + SANDOZ

AP AP AP AP AP AP

30MG/ML 30MG/ML 30MG/ML 30MG/ML 30MG/ML 30MG/ML ORAL 100MG 100MG 100MG 100MG

N013055 001 A040484 A040463 A090585 A084779 A087062 001 001 001 001 001 May Mar Aug Mar 24, 04, 30, 15, 2006 2003 2011 1982

AB AB AB AB

A040284 A040368 A040249 A040327

001 001 001 001

Jun Jun Jan Feb

19, 23, 29, 15,

1998 2000 1999 2000

OSELTAMIVIR PHOSPHATE
CAPSULE; ORAL TAMIFLU ROCHE XX XX XX + FOR SUSPENSION; ORAL TAMIFLU ROCHE XX

EQ 30MG BASE EQ 45MG BASE EQ 75MG BASE

N021087 003 N021087 002 N021087 001

Jul 02, 2007 Jul 02, 2007 Oct 27, 1999

EQ 6MG BASE/ML

N021246 002

Mar 21, 2011

OXACILLIN SODIUM
INJECTABLE; INJECTION OXACILLIN SODIUM AP + SANDOZ AP AP + AP AP +

EQ EQ EQ EQ EQ

1GM BASE/VIAL 1GM BASE/VIAL 2GM BASE/VIAL 2GM BASE/VIAL 10GM BASE/VIAL

A061490 A062737 A061490 A062737 A061490

003 001 004 002 006

Dec 23, 1986 Dec 23, 1986 May 09, 1991

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

OXACILLIN SODIUM
INJECTABLE; INJECTION

BACTOCILL IN PLASTIC CONTAINER

EQ 20MG BASE/ML XX + BAXTER HLTHCARE EQ 40MG BASE/ML XX +

3 - 321 (of 424)

N050640 001 N050640 002

Oct 26, 1989 Oct 26, 1989

OXALIPLATIN
INJECTABLE; IV (INFUSION) ELOXATIN AP + SANOFI AVENTIS US 50MG/10ML (5MG/ML) AP + 100MG/20ML (5MG/ML) OXALIPLATIN APP PHARMS AP 50MG/VIAL AP 100MG/VIAL EBEWE PHARMA AP 50MG/10ML (5MG/ML) AP 100MG/20ML (5MG/ML) FRESENIUS KABI ONCOL 50MG/10ML (5MG/ML) AP AP 100MG/20ML (5MG/ML) AP 50MG/VIAL AP 100MG/VIAL HOSPIRA INC AP 50MG/VIAL AP 100MG/VIAL HOSPIRA WORLDWIDE AP 50MG/10ML (5MG/ML) AP 100MG/20ML (5MG/ML) SANDOZ AP 50MG/10ML (5MG/ML) AP 50MG/VIAL AP 100MG/20ML (5MG/ML) AP 100MG/VIAL AP + SUN PHARMA GLOBAL 50MG/VIAL AP + 100MG/VIAL TEVA PARENTERAL AP 50MG/10ML (5MG/ML) AP 100MG/20ML (5MG/ML) ELOXATIN 200MG/40ML (5MG/ML) XX + SANOFI AVENTIS US

N021759 001 N021759 002 A078819 A078819 A078812 A078812 A078811 A078811 A078810 A078810 A078815 A078815 A078813 A078813 A078817 A090849 A078817 A090849 A078818 A078818 N022160 N022160 001 002 001 002 001 002 001 002 001 002 001 002 001 001 002 002 001 002 001 002

Jan 31, 2005 Jan 31, 2005 Jun Jun Aug Aug Jun Jun Aug Aug Sep Sep Aug Aug Jan Apr Jan Apr Aug Aug Aug Aug 02, 02, 07, 07, 10, 10, 07, 07, 30, 30, 07, 07, 24, 28, 24, 28, 07, 07, 07, 07, 2010 2010 2009 2009 2010 2010 2009 2009 2009 2009 2009 2009 2011 2011 2011 2011 2009 2009 2009 2009

N021759 003

Nov 17, 2006

OXANDROLONE
TABLET; ORAL OXANDRIN SAVIENT PHARMS AB AB + OXANDROLONE PAR PHARM AB AB SANDOZ AB AB UPSHER SMITH AB AB

2.5MG 10MG 2.5MG 10MG 2.5MG 10MG 2.5MG 10MG

N013718 001 N013718 002 A077827 A077827 A076897 A076897 A076761 A078033 001 002 001 002 001 001

Nov 05, 2001 Jun Jun Dec Dec Dec Mar 22, 22, 01, 01, 01, 22, 2007 2007 2006 2006 2006 2007

OXAPROZIN
TABLET; ORAL DAYPRO + GD SEARLE OXAPROZIN APOTEX INC CARACO DR REDDYS LABS LTD IVAX SUB TEVA PHARMS MYLAN SANDOZ TEVA

AB AB AB AB AB AB AB AB

600MG 600MG 600MG 600MG 600MG 600MG 600MG 600MG

N018841 004 A075987 A075844 A075855 A075846 A075847 A075845 A075849 001 001 001 001 001 001 001

Oct 29, 1992 Sep Jan Jan May Feb Jan Jul 02, 03, 31, 13, 28, 31, 03, 2004 2002 2001 2002 2001 2001 2002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

OXAPROZIN
TABLET; ORAL OXAPROZIN WATSON LABS AB

3 - 322 (of 424)

600MG

A075848 001

Feb 09, 2001

OXAZEPAM
CAPSULE; ORAL OXAZEPAM ACTAVIS ELIZABETH AB AB AB IVAX SUB TEVA PHARMS AB AB AB + SANDOZ AB AB AB WATSON LABS AB AB AB

10MG 15MG 30MG 10MG 15MG 30MG 10MG 15MG 30MG 10MG 15MG 30MG

A072251 A072252 A072253 A070943 A070944 A070945 A071813 A071756 A071814 A072952 A072953 A072954

001 001 001 001 001 001 001 001 001 001 001 001

Apr Apr Apr Aug Aug Aug Apr Apr Apr Sep Sep Sep

14, 14, 14, 03, 03, 03, 19, 19, 19, 28, 28, 28,

1988 1988 1988 1987 1987 1987 1988 1988 1988 1990 1990 1990

OXCARBAZEPINE
SUSPENSION; ORAL OXCARBAZEPINE RANBAXY AB TRILEPTAL AB + NOVARTIS TABLET; ORAL OXCARBAZEPINE APOTEX INC AB AB AB BRECKENRIDGE PHARM AB AB AB CADISTA PHARMS AB AB AB GLENMARK GENERICS AB AB AB ROXANE AB AB AB SUN PHARM INDS AB AB AB TARO AB AB AB TEVA PHARMS AB AB AB TRILEPTAL NOVARTIS AB AB AB +

300MG/5ML 300MG/5ML

A078734 001 N021285 001

Jun 26, 2009 May 25, 2001

150MG 300MG 600MG 150MG 300MG 600MG 150MG 300MG 600MG 150MG 300MG 600MG 150MG 300MG 600MG 150MG 300MG 600MG 150MG 300MG 600MG 150MG 300MG 600MG 150MG 300MG 600MG

A077747 A077747 A077747 A078069 A078069 A078069 A090239 A090239 A090239 A077802 A077802 A077802 A077795 A077795 A077795 A077794 A077794 A077794 A077801 A077801 A077801 A078005 A078005 A078005

001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003

Apr Apr Apr Jan Jan Jan Jan Jan Jan Oct Oct Oct Oct Oct Oct Oct Oct Oct Nov Nov Nov Dec Dec Dec

09, 09, 09, 11, 11, 11, 25, 25, 25, 09, 09, 09, 09, 09, 09, 09, 09, 09, 15, 15, 15, 11, 11, 11,

2008 2008 2008 2008 2008 2008 2010 2010 2010 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007

N021014 001 N021014 002 N021014 003

Jan 14, 2000 Jan 14, 2000 Jan 14, 2000

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

OXICONAZOLE NITRATE
CREAM; TOPICAL

OXISTAT

XX + ALTANA LOTION; TOPICAL

OXISTAT

XX + FOUGERA PHARMS

3 - 323 (of 424)

EQ 1% BASE

N019828 001

Dec 30, 1988

EQ 1% BASE

N020209 001

Sep 30, 1992

OXTRIPHYLLINE

TABLET, EXTENDED RELEASE; ORAL

CHOLEDYL SA
400MG XX + WARNER CHILCOTT 600MG XX +

A087863 001 A086742 001

May 24, 1983

OXYBUTYNIN

FILM, EXTENDED RELEASE; TRANSDERMAL

OXYTROL
3.9MG/24HR XX + WATSON LABS (UTAH)
GEL, METERED; TRANSDERMAL

ANTUROL
XX + ANTARES PHARMA INC 3%

N021351 002

Feb 26, 2003

N202513 001

Dec 07, 2011

OXYBUTYNIN CHLORIDE

GEL; TRANSDERMAL

GELNIQUE
XX + WATSON LABS SYRUP; ORAL OXYBUTYNIN CHLORIDE MIKART NOVEX PHARM ASSOC SILARX VINTAGE PHARMS + WOCKHARDT TABLET; ORAL DITROPAN + JANSSEN PHARMS OXYBUTYNIN CHLORIDE PLIVA USL PHARMA VINTAGE PHARMS

10%(100MG/PACKET)

N022204 001

Jan 27, 2009

AA AA AA AA AA AA

5MG/5ML 5MG/5ML 5MG/5ML 5MG/5ML 5MG/5ML 5MG/5ML

A075039 A074997 A075137 A074520 A076682 A074868

001 001 001 001 001 001

Jan Oct Dec Mar Dec Feb

29, 15, 18, 29, 28, 12,

1999 1997 1998 1996 2004 1997

AB AB AB AB

5MG 5MG 5MG 5MG

N017577 001 A071655 001 A074625 001 A075079 001 Nov 14, 1988 Jul 31, 1996 Oct 31, 1997

TABLET, EXTENDED RELEASE; ORAL DITROPAN XL JANSSEN PHARMS AB 5MG AB 10MG AB + 15MG OXYBUTYNIN CHLORIDE IMPAX PHARMS AB 5MG AB 10MG AB 15MG MYLAN AB 5MG AB 10MG AB 15MG OSMOTICA PHARM AB 5MG AB 10MG AB 15MG

N020897 001 N020897 002 N020897 003 A076745 A076745 A076745 A076702 A076644 A078293 A078503 A078503 A078503 002 003 001 001 001 001 001 002 003

Dec 16, 1998 Dec 16, 1998 Jun 22, 1999 May May Nov Nov Nov May Feb Feb Feb 09, 09, 09, 09, 09, 10, 04, 04, 04, 2007 2007 2006 2006 2006 2007 2009 2009 2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

OXYCODONE HYDROCHLORIDE
CAPSULE; ORAL
OXYCODONE HYDROCHLORIDE
5MG XX + LEHIGH VALLEY SOLUTION; ORAL
OXYCODONE HYDROCHLORIDE
100MG/5ML XX + LEHIGH VALLEY TABLET; ORAL OXYCODONE HYDROCHLORIDE ACTAVIS TOTOWA 15MG AB 30MG AB ALVOGEN INC 5MG AB 15MG AB 30MG AB AVANTHI INC 5MG AB 10MG AB 15MG AB 20MG AB 30MG AB COASTAL PHARMS 5MG AB 15MG AB 30MG AB COREPHARMA 5MG AB 15MG AB 30MG AB MALLINCKRODT 15MG AB 30MG AB MALLINCKRODT INC 5MG AB NESHER PHARMS 5MG AB 10MG AB 15MG AB 20MG AB 30MG AB RHODES PHARMS 5MG AB 10MG AB 15MG AB 20MG AB 30MG AB SUN PHARM INDS INC 5MG AB 15MG AB 30MG AB VINTAGE PHARMS 5MG AB 15MG AB 30MG AB ROXICODONE XANODYNE PHARMS AB 5MG AB + 15MG AB 30MG OXECTA KING PHARMS R AND D 5MG XX 7.5MG XX TABLET, EXTENDED RELEASE; ORAL OXYCONTIN PURDUE PHARMA LP 10MG XX 15MG XX 20MG XX 30MG XX 40MG XX + 60MG XX 80MG XX

3 - 324 (of 424)

N200534 001

Oct 20, 2010

N200535 001

Oct 20, 2010

A076636 A076636 A202116 A202116 A202116 A091393 A091393 A091393 A091393 A091393 A091313 A091313 A091313 A090895 A090895 A090895 A076758 A076758 A078206 A077290 A077290 A077290 A077290 A077290 A091490 A091490 A091490 A091490 A091490 A090659 A090659 A090659 A077712 A077712 A077712

001 002 001 002 003 001 002 003 004 005 001 002 003 001 002 003 001 002 001 001 002 003 004 005 001 002 003 004 005 001 002 003 003 001 002

Feb Feb Dec Dec Dec Aug Aug Aug Aug Aug Feb Feb Feb Aug Aug Aug Jun Jun Mar Dec Dec Dec Dec Dec Mar Mar Mar Mar Mar Apr Apr Apr Mar Jan Jan

06, 06, 30, 30, 30, 31, 31, 31, 31, 31, 18, 18, 18, 24, 24, 24, 30, 30, 19, 08, 08, 08, 08, 08, 09, 09, 09, 09, 09, 10, 10, 10, 02, 31, 31,

2004 2004 2011 2011 2011 2009 2009 2009 2009 2009 2011 2011 2011 2009 2009 2009 2004 2004 2007 2005 2005 2005 2005 2005 2011 2011 2011 2011 2011 2009 2009 2009 2009 2007 2007

N021011 003 N021011 001 N021011 002 N202080 001 N202080 002

May 15, 2009 Aug 31, 2000 Aug 31, 2000 Jun 17, 2011 Jun 17, 2011

N022272 N022272 N022272 N022272 N022272 N022272 N022272

001 002 003 004 005 006 007

Apr Apr Apr Apr Apr Apr Apr

05, 05, 05, 05, 05, 05, 05,

2010 2010 2010 2010 2010 2010 2010

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

OXYMETHOLONE
TABLET; ORAL

ANADROL-50

XX + MEDA PHARMS

3 - 325 (of 424)

50MG

N016848 001

OXYMORPHONE HYDROCHLORIDE
INJECTABLE; INJECTION

OPANA

XX + ENDO PHARMS

1MG/ML

N011707 002

AB AB AB AB AB AB

TABLET; ORAL OPANA ENDO PHARMS 5MG + 10MG OXYMORPHONE HYDROCHLORIDE ROXANE 5MG 10MG TEVA 5MG 10MG

N021611 001 N021611 002 A090964 A090964 A091443 A091443 001 002 002 001

Jun 22, 2006 Jun 22, 2006 Sep Sep Feb Feb 27, 27, 15, 15, 2010 2010 2011 2011

TABLET, EXTENDED RELEASE; ORAL OPANA ER ENDO PHARMS AB 5MG AB 10MG AB 20MG AB 30MG AB + 40MG OXYMORPHONE HYDROCHLORIDE ACTAVIS AB 7.5MG AB 15MG IMPAX LABS AB 5MG AB 7.5MG AB 10MG AB 15MG AB 20MG AB 30MG AB 40MG OPANA ER ENDO PHARMS 5MG XX 7.5MG XX 10MG XX 15MG XX 20MG XX 30MG XX 40MG XX

N021610 N021610 N021610 N021610 N021610 A079046 A079046 A079087 A079087 A079087 A079087 A079087 A079087 A079087 N201655 N201655 N201655 N201655 N201655 N201655 N201655

001 002 003 007 004 001 002 001 002 003 004 005 006 007 001 002 003 004 005 006 007

Jun Jun Jun Feb Jun Dec Dec Jun Dec Jun Dec Jun Jul Jun Dec Dec Dec Dec Dec Dec Dec

22, 22, 22, 29, 22, 13, 13, 14, 21, 14, 21, 14, 22, 14, 09, 09, 09, 09, 09, 09, 09,

2006 2006 2006 2008 2006 2010 2010 2010 2010 2010 2010 2010 2010 2010 2011 2011 2011 2011 2011 2011 2011

OXYTETRACYCLINE HYDROCHLORIDE; POLYMYXIN B SULFATE

OINTMENT; OPHTHALMIC

TERRAMYCIN W/ POLYMYXIN B SULFATE

EQ 5MG BASE/GM;10,000 UNITS/GM XX + PFIZER

A061015 001

OXYTOCIN
INJECTABLE; INJECTION OXYTOCIN + APP PHARMS + + BAXTER HLTHCARE CORP + TEVA PARENTERAL

AP AP AP AP AP AP

10USP UNITS/ML (10USP UNITS/ML) 100USP UNITS/10ML (10USP UNITS/ML) 10USP UNITS/ML (10USP UNITS/ML) 100USP UNITS/10ML (10USP UNITS/ML) 10USP UNITS/ML (10USP UNITS/ML) 100USP UNITS/10ML (10USP UNITS/ML)

N018248 N018248 N018243 N018243 A077453 A077453

001 002 001 002 001 002

Jan 10, 2007 Jan 24, 2008 Jan 24, 2008

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

OXYTOCIN
INJECTABLE; INJECTION PITOCIN AP + JHP PHARMS AP OXYTOCIN XX + APP PHARMS

3 - 326 (of 424)

10USP UNITS/ML (10USP UNITS/ML) 100USP UNITS/10ML (10USP UNITS/ML) 300USP UNITS/30ML (10USP UNITS/ML)

N018261 001 N018261 002 N018248 003

Jul 27, 2007 Jul 27, 2007

PACLITAXEL
FOR SUSPENSION; IV (INFUSION)
ABRAXANE
XX + ABRAXIS BIOSCIENCE 100MG/VIAL INJECTABLE; INJECTION PACLITAXEL ACCORD HLTHCARE INC ACTAVIS TOTOWA BEDFORD EBEWE PHARMA FRESENIUS KABI ONCOL + HOSPIRA MYLAN ONCO THERAPIES LTD TEVA PARENTERAL

N021660 001

Jan 07, 2005

AP AP AP AP AP AP AP AP AP

6MG/ML 6MG/ML 6MG/ML 6MG/ML 6MG/ML 6MG/ML 6MG/ML 6MG/ML 6MG/ML

A075436 A090130 A075190 A078167 A077574 A076131 A075278 A091540 A075184

001 001 001 001 001 001 001 001 001

Nov Dec Jan Dec Nov May Jan Sep Jan

12, 09, 28, 26, 27, 08, 25, 29, 25,

2004 2009 2002 2007 2006 2002 2002 2011 2002

PALIPERIDONE
TABLET, EXTENDED RELEASE; ORAL INVEGA JANSSEN PHARMS 1.5MG XX 3MG XX 6MG XX + 9MG XX

N021999 N021999 N021999 N021999

006 001 002 003

Aug Dec Dec Dec

26, 19, 19, 19,

2008 2006 2006 2006

PALIPERIDONE PALMITATE
SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR INVEGA SUSTENNA JANSSEN PHARMS 39MG/0.25ML (39MG/0.25ML) XX 78MG/0.5ML (78MG/0.5ML) XX 117MG/0.75ML (117MG/0.75ML) XX + 156MG/ML (156MG/ML) XX 234MG/1.5ML (156MG/ML) XX

N022264 N022264 N022264 N022264 N022264

001 002 003 004 005

Jul Jul Jul Jul Jul

31, 31, 31, 31, 31,

2009 2009 2009 2009 2009

PALONOSETRON HYDROCHLORIDE
INJECTABLE; INTRAVENOUS

ALOXI

XX + HELSINN HLTHCARE XX +

EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)

N021372 002 N021372 001

Feb 29, 2008 Jul 25, 2003

PAMIDRONATE DISODIUM
INJECTABLE; INJECTION AREDIA AP + NOVARTIS PAMIDRONATE DISODIUM APP PHARMS AP AP AP AP AREVA PHARMS AP AP

30MG/VIAL 30MG/VIAL 30MG/10ML (3MG/ML) 90MG/VIAL 90MG/10ML (9MG/ML) 30MG/VIAL 60MG/VIAL

N020036 001 A075773 A076207 A075773 A076207 A077433 A077433 001 001 002 002 001 002

Oct 31, 1991 May May May May Nov Nov 06, 17, 06, 17, 26, 26, 2002 2002 2002 2002 2008 2008

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

PAMIDRONATE DISODIUM
INJECTABLE; INJECTION PAMIDRONATE DISODIUM AREVA PHARMS AP BEDFORD AP AP + AP AP + AP + HOSPIRA AP + AP + LUITPOLD AP AP MN PHARMS AP AP MUSTAFA NEVZAT AP AP PFIZER AP AP PLIVA LACHEMA AP AP AP SUN PHARMA GLOBAL AP AP TEVA PARENTERAL AP AP

3 - 327 (of 424)

90MG/VIAL 30MG/VIAL 30MG/10ML 90MG/VIAL 90MG/10ML 30MG/10ML 60MG/10ML 90MG/10ML 30MG/10ML 90MG/10ML 30MG/VIAL 90MG/VIAL 30MG/10ML 90MG/10ML 30MG/10ML 90MG/10ML 30MG/10ML 60MG/10ML 90MG/10ML 30MG/VIAL 90MG/VIAL 30MG/10ML 90MG/10ML

(3MG/ML) (9MG/ML) (3MG/ML) (6MG/ML) (9MG/ML) (3MG/ML) (9MG/ML)

(3MG/ML) (9MG/ML) (3MG/ML) (9MG/ML) (3MG/ML) (6MG/ML) (9MG/ML)

(3MG/ML) (9MG/ML)

A077433 A075290 N021113 A075290 N021113 A075841 A075841 A075841 A078942 A078942 A078300 A078300 A078373 A078373 A078520 A078520 A078156 A078156 A078156 A077703 A077703 A076153 A076153

003 001 001 003 002 001 002 003 001 002 001 002 001 002 001 002 001 002 003 001 002 001 002

Nov Apr Mar Apr Mar Jun Jun Jun Jul Jul Mar Mar Dec Dec Oct Oct Aug Aug Aug Dec Dec Mar Mar

26, 30, 04, 30, 04, 27, 27, 27, 25, 25, 10, 10, 23, 23, 31, 31, 19, 19, 19, 24, 24, 27, 27,

2008 2001 2002 2001 2002 2002 2002 2002 2008 2008 2009 2009 2008 2008 2008 2008 2008 2008 2008 2008 2008 2002 2002

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
CAPSULE, DELAYED RELEASE; ORAL CREON ABBOTT PRODS 30,000USP UNITS;6,000USP XX UNITS;19,000USP UNITS 60,000USP UNITS;12,000USP XX UNITS;38,000USP UNITS 120,000USP UNITS;24,000USP XX + UNITS;76,000USP UNITS PANCREAZE JANSSEN PHARMS 17,500USP/ UNITS;4,200USP/ XX UNITS;10,000USP/ UNITS 43,750USP/ UNITS;10,500USP/ XX UNITS;25,000USP/ UNITS 70,000USP/ UNITS;16,800USP/ XX UNITS;40,000USP/ UNITS 61,000USP/ UNITS;21,000USP/ XX + UNITS;37,000USP/ UNITS ZENPEP APTALIS PHARMA US 27,000USP UNITS;5,000USP XX UNITS;17,000USP UNITS 55,000USP UNITS;10,000USP XX UNITS;34,000USP UNITS 82,000USP UNITS;15,000USP XX UNITS;51,000USP UNITS 109,000USP UNITS;20,000USP XX + UNITS;68,000USP UNITS

N020725 001 N020725 002 N020725 003

Apr 30, 2009 Apr 30, 2009 Apr 30, 2009

N022523 001 N022523 002 N022523 004 N022523 003

Apr 12, 2010 Apr 12, 2010 Apr 12, 2010 Apr 12, 2010

N022210 001 N022210 002 N022210 003 N022210 004

Aug 27, 2009 Aug 27, 2009 Aug 27, 2009 Aug 27, 2009

PANCURONIUM BROMIDE
INJECTABLE; INJECTION PANCURONIUM BROMIDE HOSPIRA AP AP + TEVA PARENTERAL AP +

1MG/ML 1MG/ML 2MG/ML

A072320 001 A072759 001 A072760 001

Jan 19, 1989 Jul 31, 1990 Jul 31, 1990

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

PANTOPRAZOLE SODIUM
FOR SUSPENSION, DELAYED RELEASE; ORAL

PROTONIX

EQ 40MG BASE XX + WYETH PHARMS INC INJECTABLE; IV (INFUSION)
PROTONIX IV
XX + WYETH PHARMS INC EQ 40MG BASE/VIAL TABLET, DELAYED RELEASE; ORAL PANTOPRAZOLE SODIUM ACTAVIS TOTOWA AB EQ 20MG AB EQ 40MG DR REDDYS LABS LTD AB EQ 20MG AB EQ 40MG JUBILANT ORGANOSYS AB EQ 20MG AB EQ 40MG KUDCO IRELAND AB EQ 20MG AB EQ 40MG MATRIX LABS LTD AB EQ 20MG AB EQ 40MG SUN PHARMA GLOBAL AB EQ 20MG AB EQ 40MG TEVA AB EQ 20MG AB EQ 40MG TORRENT PHARMS AB EQ 20MG AB EQ 40MG WOCKHARDT AB EQ 20MG AB EQ 40MG PROTONIX WYETH PHARMS INC AB EQ 20MG AB + EQ 40MG

3 - 328 (of 424)

N022020 001

Nov 14, 2007

N020988 001

Mar 22, 2001

BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE

A090797 A090797 A077619 A077619 A090901 A090901 A078281 A078281 A090970 A090970 A077058 A077058 A077056 A077056 A090074 A090074 A091231 A091231

001 002 001 002 001 002 001 002 001 002 001 002 001 002 001 002 001 002

Feb Feb Jan Jan Aug Aug Jan Jan Jan Jan Sep Sep Aug Aug Jan Jan Jan Jan

07, 07, 19, 19, 30, 30, 20, 20, 19, 19, 10, 10, 02, 02, 19, 19, 19, 19,

2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2007 2007 2007 2007 2011 2011 2011 2011

N020987 002 N020987 001

Jun 12, 2001 Feb 02, 2000

PARICALCITOL
CAPSULE; ORAL ZEMPLAR ABBOTT XX XX XX + INJECTABLE; INJECTION PARICALCITOL SANDOZ CANADA INC AP AP ZEMPLAR AP + ABBOTT AP +

1MCG 2MCG 4MCG

N021606 001 N021606 002 N021606 003

May 26, 2005 May 26, 2005 May 26, 2005

0.002MG/ML 0.005MG/ML 0.002MG/ML 0.005MG/ML

A091108 001 A091108 002 N020819 002 N020819 001

Jul 27, 2011 Jul 27, 2011 Feb 01, 2000 Apr 17, 1998

PAROMOMYCIN SULFATE
CAPSULE; ORAL PAROMOMYCIN SULFATE AA + CARACO HERITAGE PHARMS INC AA

EQ 250MG BASE EQ 250MG BASE

A064171 001 A065173 001

Jun 30, 1997 Dec 14, 2007

PAROXETINE HYDROCHLORIDE
SUSPENSION; ORAL PAROXETINE HYDROCHLORIDE APOTEX INC AB EQ 10MG BASE/5ML PAXIL AB + GLAXOSMITHKLINE EQ 10MG BASE/5ML

A077395 001 N020710 001

Dec 05, 2006 Jun 25, 1997

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

PAROXETINE HYDROCHLORIDE
TABLET; ORAL PAROXETINE HYDROCHLORIDE ALPHAPHARM EQ EQ EQ EQ APOTEX EQ EQ EQ EQ AUROBINDO PHARMA EQ EQ EQ EQ CARACO EQ EQ EQ EQ MYLAN EQ EQ EQ EQ TEVA EQ EQ EQ EQ ZYDUS PHARMS USA EQ EQ EQ EQ PAXIL GLAXOSMITHKLINE EQ EQ EQ + EQ

3 - 329 (of 424)

AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB

10MG 20MG 30MG 40MG 10MG 20MG 30MG 40MG 10MG 20MG 30MG 40MG 10MG 20MG 30MG 40MG 10MG 20MG 30MG 40MG 10MG 20MG 30MG 40MG 10MG 20MG 30MG 40MG 10MG 20MG 30MG 40MG

BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE

A075716 A075716 A075716 A075716 A075356 A075356 A075356 A075356 A078406 A078406 A078406 A078406 A078194 A078194 A078194 A078194 A078902 A078902 A078902 A078902 A076618 A076618 A076618 A076618 A077584 A077584 A077584 A077584 N020031 N020031 N020031 N020031

001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 005

Mar Mar Mar Mar Jul Jul Jul Jul Jul Jul Jul Jul Jun Jun Jun Jun Mar Mar Mar Mar Aug Aug Aug Aug Mar Mar Mar Mar Dec Dec Dec Dec

08, 08, 08, 08, 30, 30, 30, 30, 25, 25, 25, 25, 29, 29, 29, 29, 13, 13, 13, 13, 15, 15, 15, 15, 07, 07, 07, 07, 29, 29, 29, 29,

2004 2004 2004 2004 2003 2003 2003 2003 2007 2007 2007 2007 2007 2007 2007 2007 2008 2008 2008 2008 2005 2005 2005 2005 2007 2007 2007 2007 1992 1992 1992 1992

AB AB AB AB AB AB

TABLET, EXTENDED RELEASE; ORAL PAROXETINE HYDROCHLORIDE MYLAN EQ 12.5MG BASE EQ 25MG BASE EQ 37.5MG BASE PAXIL CR GLAXOSMITHKLINE EQ 12.5MG BASE EQ 25MG BASE + EQ 37.5MG BASE

A077873 001 A077873 002 A091427 001 N020936 001 N020936 002 N020936 003

Jun 29, 2007 Jun 29, 2007 Apr 14, 2011 Feb 16, 1999 Feb 16, 1999 Dec 06, 2000

PAROXETINE MESYLATE
TABLET; ORAL PEXEVA NOVEN THERAP XX XX XX XX +

EQ EQ EQ EQ

10MG 20MG 30MG 40MG

BASE BASE BASE BASE

N021299 N021299 N021299 N021299

001 002 003 004

Jul Jul Jul Jul

03, 03, 03, 03,

2003 2003 2003 2003

PAZOPANIB HYDROCHLORIDE
TABLET; ORAL VOTRIENT GLAXOSMITHKLINE XX XX +

EQ 200MG BASE EQ 400MG BASE

N022465 001 N022465 002

Oct 19, 2009 Oct 19, 2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

PEGADEMASE BOVINE
INJECTABLE; INJECTION
ADAGEN
XX + SIGMA TAU

3 - 330 (of 424)

250 UNITS/ML

N019818 001

Mar 21, 1990

PEGAPTANIB SODIUM
INJECTABLE; INTRAVITREAL
MACUGEN
XX + EYETECH INC

EQ 0.3MG ACID/0.09ML

N021756 001

Dec 17, 2004

PEGVISOMANT
INJECTABLE; SUBCUTANEOUS
SOMAVERT
XX + PHARMACIA AND UPJOHN XX + XX +

10MG/VIAL 15MG/VIAL 20MG/VIAL

N021106 001 N021106 002 N021106 003

Mar 25, 2003 Mar 25, 2003 Mar 25, 2003

PEMETREXED DISODIUM
INJECTABLE; IV (INFUSION)
ALIMTA
XX + LILLY
EQ 100MG BASE/VIAL XX +
EQ 500MG BASE/VIAL

N021462 002 N021462 001

Sep 07, 2007 Feb 04, 2004

PEMIROLAST POTASSIUM
SOLUTION/DROPS; OPHTHALMIC
ALAMAST
0.1% XX + SANTEN

N021079 001

Sep 24, 1999

PENBUTOLOL SULFATE
TABLET; ORAL

LEVATOL

XX + SCHWARZ PHARMA

20MG

N018976 004

Jan 05, 1989

PENCICLOVIR SODIUM
CREAM; TOPICAL

DENAVIR

XX + DENCO ASSET

1%

N020629 001

Sep 24, 1996

PENICILLAMINE
CAPSULE; ORAL

CUPRIMINE

XX + ATON TABLET; ORAL

DEPEN

XX + MEDA PHARMS

250MG

N019853 001

250MG

N019854 001

PENICILLIN G BENZATHINE
INJECTABLE; INJECTION BICILLIN L-A BC + KING PHARMS PERMAPEN BC PFIZER BICILLIN L-A XX + KING PHARMS

600,000 UNITS/ML 600,000 UNITS/ML 300,000 UNITS/ML

N050141 001 A060014 001 N050141 003

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE
INJECTABLE; INJECTION

BICILLIN C-R

XX + KING PHARMS XX + BICILLIN C-R 900/300

XX + KING PHARMS

3 - 331 (of 424)

150,000 UNITS/ML;150,000 UNITS/ML 300,000 UNITS/ML;300,000 UNITS/ML 900,000 UNITS/2ML;300,000 UNITS/2ML

N050138 002 N050138 001

N050138 003

PENICILLIN G POTASSIUM
INJECTABLE; INJECTION PENICILLIN G POTASSIUM APP PHARMS AP 5,000,000 UNITS/VIAL AP 20,000,000 UNITS/VIAL HANFORD GC AP 5,000,000 UNITS/VIAL AP 20,000,000 UNITS/VIAL SANDOZ AP 5,000,000 UNITS/VIAL AP 20,000,000 UNITS/VIAL PFIZERPEN AP + PFIZER 5,000,000 UNITS/VIAL AP + 20,000,000 UNITS/VIAL PENICILLIN G POTASSIUM HANFORD GC 1,000,000 UNITS/VIAL XX PENICILLIN G POTASSIUM IN PLASTIC CONTAINER 20,000 UNITS/ML XX + BAXTER HLTHCARE 40,000 UNITS/ML XX + 60,000 UNITS/ML XX +

A065448 A065448 A065149 A065149 A065079 A065079

001 002 002 003 002 003

Aug Aug Jul Jul Aug Aug

18, 18, 23, 23, 30, 30,

2009 2009 2009 2009 2002 2002

A060657 002 A060657 003 A065149 001 N050638 001 N050638 002 N050638 003 Jul 23, 2009 Jun 25, 1990 Jun 25, 1990 Jun 25, 1990

PENICILLIN G PROCAINE
INJECTABLE; INJECTION

PENICILLIN G PROCAINE

XX + KING PHARMS XX +

300,000 UNITS/ML 600,000 UNITS/ML

A060101 002 A060101 001

PENICILLIN G SODIUM
INJECTABLE; IM-IV

PENICILLIN G SODIUM

XX + SANDOZ

5,000,000 UNITS/VIAL

A065068 001

Feb 26, 2001

PENICILLIN V POTASSIUM
FOR SOLUTION; ORAL PENICILLIN V POTASSIUM DAVA PHARMS INC AA AA PENICILLIN-VK TEVA AA AA + TABLET; ORAL PENICILLIN V POTASSIUM AUROBINDO PHARMA AB AB DAVA PHARMS INC AB AB SANDOZ AB AB + PENICILLIN-VK TEVA AB AB

EQ 125MG BASE/5ML EQ 250MG BASE/5ML EQ 125MG BASE/5ML EQ 250MG BASE/5ML

A062981 001 A062981 002 A060456 001 A060456 002

Feb 10, 1989 Feb 10, 1989

EQ EQ EQ EQ EQ EQ

250MG 500MG 250MG 500MG 250MG 500MG

BASE BASE BASE BASE BASE BASE

A065435 A065435 A062936 A062935 A064071 A064071

001 002 001 001 001 002

Apr Apr Nov Nov Nov Nov

29, 29, 25, 23, 30, 30,

2008 2008 1988 1988 1995 1995

EQ 250MG BASE EQ 500MG BASE

A060711 002 A060711 003

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

PENTAMIDINE ISETHIONATE
FOR SOLUTION; INHALATION
NEBUPENT
XX + APP PHARMS

3 - 332 (of 424)

300MG/VIAL

N019887 001

Jun 15, 1989

INJECTABLE; INJECTION PENTAM AP + APP PHARMS 300MG/VIAL PENTAMIDINE ISETHIONATE WATSON LABS AP 300MG/VIAL

N019264 001 A074303 001

Oct 16, 1984 Aug 17, 1995

PENTAZOCINE LACTATE
INJECTABLE; INJECTION
TALWIN
XX + HOSPIRA

EQ 30MG BASE/ML

N016194 001

PENTOBARBITAL SODIUM
INJECTABLE; INJECTION
NEMBUTAL SODIUM
XX + LUNDBECK INC

50MG/ML

A083246 001

PENTOSAN POLYSULFATE SODIUM

CAPSULE; ORAL
ELMIRON
XX + JANSSEN PHARMS

100MG

N020193 001

Sep 26, 1996

PENTOSTATIN
INJECTABLE; INJECTION NIPENT AP + HOSPIRA INC PENTOSTATIN BEDFORD LABS AP

10MG/VIAL 10MG/VIAL

N020122 001 A077841 001

Oct 11, 1991 Aug 07, 2007

PENTOXIFYLLINE
TABLET, EXTENDED RELEASE; PENTOXIFYLLINE APOTEX IMPAX LABS MYLAN PLIVA VALEANT INTL WATSON LABS PENTOXIL UPSHER SMITH TRENTAL + SANOFI AVENTIS US ORAL 400MG 400MG 400MG 400MG 400MG 400MG 400MG 400MG A075191 A075093 A074425 A074874 A075028 A075107 001 001 001 001 001 001 Jun Aug Jul May Jul Sep 09, 10, 08, 25, 20, 04, 1999 1999 1997 1999 1998 1998

AB AB AB AB AB AB AB AB

A074962 001 N018631 001

Mar 31, 1999 Aug 30, 1984

PERFLUTREN
INJECTABLE; INTRAVENOUS
DEFINITY
XX + LANTHEUS MEDCL

6.52MG/ML

N021064 001

Jul 31, 2001

PERINDOPRIL ERBUMINE
TABLET; ORAL ACEON ABBOTT PRODS AB AB AB + PERINDOPRIL ERBUMINE APOTEX AB

2MG 4MG 8MG 2MG

N020184 001 N020184 002 N020184 003 A090463 001

Dec 30, 1993 Dec 30, 1993 Dec 30, 1993 Aug 30, 2010

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

PERINDOPRIL ERBUMINE
TABLET; ORAL PERINDOPRIL ERBUMINE APOTEX AB AB AUROBINDO PHARMA AB AB AB IVAX PHARMS AB AB AB LUPIN LTD AB AB AB ROXANE AB AB AB

3 - 333 (of 424)

4MG 8MG 2MG 4MG 8MG 2MG 4MG 8MG 2MG 4MG 8MG 2MG 4MG 8MG

A090463 A090463 A079070 A079070 A079070 A078138 A078138 A078138 A078263 A078263 A078263 A090072 A090072 A090072

002 003 001 002 003 001 002 003 001 002 003 001 002 003

Aug Aug Nov Nov Nov Nov Nov Nov Jan Jan Jan Nov Nov Nov

30, 30, 10, 10, 10, 10, 10, 10, 27, 27, 27, 10, 10, 10,

2010 2010 2009 2009 2009 2009 2009 2009 2010 2010 2010 2009 2009 2009

PERMETHRIN
CREAM; TOPICAL ELIMITE AB + ALLERGAN PERMETHRIN ACTAVIS MID ATLANTIC AB PERRIGO NEW YORK AB

5% 5% 5%

N019855 001 A074806 001 A076369 001

Aug 25, 1989 Jan 23, 1998 Apr 21, 2003

PERPHENAZINE
TABLET; ORAL PERPHENAZINE SANDOZ AB AB AB AB + VINTAGE PHARMS AB AB AB AB

2MG 4MG 8MG 16MG 2MG 4MG 8MG 16MG

A089683 A089684 A089685 A089686 A040226 A040226 A040226 A040226

001 001 001 001 001 002 003 004

Dec Dec Dec Dec Dec Dec Dec Dec

08, 08, 08, 08, 31, 31, 31, 31,

1988 1988 1988 1988 1998 1998 1998 1998

PHENDIMETRAZINE TARTRATE
CAPSULE, EXTENDED RELEASE; ORAL BONTRIL BC VALEANT 105MG PHENDIMETRAZINE TARTRATE BC + SANDOZ 105MG TABLET; ORAL BONTRIL PDM + VALEANT 35MG PHENDIMETRAZINE TARTRATE KVK TECH 35MG MIKAH PHARMA 35MG MIKART 35MG SANDOZ 35MG

A088021 001 N018074 001

Sep 21, 1982

AA AA AA AA AA

A085272 001 A091042 A040762 A089452 A085588 001 001 001 001 Aug 31, 2010 Jan 28, 2008 Oct 30, 1991

PHENELZINE SULFATE
TABLET; ORAL NARDIL AB + PARKE DAVIS PHENELZINE SULFATE NOVEL LABS INC AB

EQ 15MG BASE EQ 15MG BASE

N011909 002 A200181 001 Dec 08, 2010

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

PHENOXYBENZAMINE HYDROCHLORIDE
CAPSULE; ORAL

DIBENZYLINE

XX + WELLSPRING PHARM

3 - 334 (of 424)

10MG

N008708 001

PHENTERMINE HYDROCHLORIDE
CAPSULE; ORAL ADIPEX-P AA + TEVA 37.5MG PHENTERMINE HYDROCHLORIDE BARR AA 15MG AA 30MG KVK TECH AA 15MG AA 30MG AA 30MG AA 37.5MG LANNETT AA 30MG AA 30MG LANNETT HOLDINGS INC 37.5MG AA MUTUAL PHARM AA 30MG AA + SANDOZ 15MG AA + 30MG AA + 30MG TABLET; ORAL ADIPEX-P + TEVA 37.5MG PHENTERMINE HYDROCHLORIDE ACTAVIS ELIZABETH 37.5MG BARR 37.5MG CARACO 37.5MG ELITE LABS 37.5MG KVK TECH 37.5MG LANNETT 37.5MG MUTUAL PHARM 37.5MG VINTAGE PHARMS 37.5MG PHENTERMINE HYDROCHLORIDE + SANDOZ 30MG

A088023 001 A090591 A090591 A040886 A040875 A040886 A040887 A087022 A091359 A201961 A040525 A087190 A086945 A087190 001 002 002 001 001 001 001 001 001 001 002 001 001

Aug 02, 1983 Mar Mar Mar Mar Mar Apr Feb Jul Jul Oct 18, 18, 31, 21, 31, 24, 03, 16, 20, 23, 2010 2010 2008 2008 2008 2008 1983 2010 2011 2003

Jul 20, 1983

AA AA AA AA AA AA AA AA AA XX

A085128 001 A040276 A090470 A040790 A200272 A040876 A040555 A040526 A040377 001 001 001 001 001 001 001 001 Nov Aug Aug Jan Mar Apr Oct Jan 25, 31, 21, 31, 31, 15, 23, 04, 1998 2009 2007 2011 2008 2005 2003 2002

A088605 001

Sep 28, 1987

TABLET, ORALLY DISINTEGRATING; ORAL SUPRENZA CITIUS PHARMS 15MG XX 30MG XX +

N202088 001 N202088 002

Jun 13, 2011 Jun 13, 2011

PHENTERMINE RESIN COMPLEX

CAPSULE, EXTENDED RELEASE; ORAL PHENTERMINE RESIN COMPLEX XX LANNETT HOLDINGS INC EQ 15MG BASE XX EQ 30MG BASE

A040872 001 A040872 002

Jul 28, 2011 Jul 28, 2011

PHENTOLAMINE MESYLATE
INJECTABLE; INJECTION PHENTOLAMINE MESYLATE BEDFORD AP REGITINE AP + NOVARTIS ORAVERSE XX + SEPTODONT HOLDING

5MG/VIAL 5MG/VIAL 0.4MG/1.7ML

A040235 001 N008278 003 N022159 001

Mar 11, 1998

May 09, 2008

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
SYRUP; ORAL PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE VINTAGE AA 5MG/5ML;6.25MG/5ML PROMETH VC PLAIN AA + ACTAVIS MID ATLANTIC 5MG/5ML;6.25MG/5ML PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE AMNEAL PHARMS AA 5MG/5ML;6.25MG/5ML

3 - 335 (of 424)

A040654 001 A088761 001 A040902 001

Dec 07, 2006 Nov 08, 1984 Aug 25, 2009

PHENYTOIN
SUSPENSION; ORAL DILANTIN-125 AB + PARKE DAVIS PHENYTOIN TARO AB VISTAPHARM AB AB WOCKHARDT AB TABLET, CHEWABLE; ORAL

DILANTIN

XX + PFIZER PHARMS

125MG/5ML 125MG/5ML 125MG/5ML 125MG/5ML 125MG/5ML

N008762 001 A040521 A040342 A040610 A040420 001 001 001 001 Mar Jan Aug Apr 08, 31, 18, 19, 2004 2001 2005 2002

50MG

A084427 001

PHENYTOIN SODIUM
CAPSULE; ORAL DILANTIN + PARKE DAVIS 30MG EXTENDED + 100MG EXTENDED EXTENDED PHENYTOIN SODIUM AMNEAL PHARMS NY 100MG EXTENDED MYLAN 100MG EXTENDED SUN PHARM INDS 200MG EXTENDED 300MG EXTENDED SUN PHARM INDS (IN) 100MG EXTENDED TARO 100MG EXTENDED WOCKHARDT 30MG EXTENDED WOCKHARDT USA 100MG EXTENDED PHENYTEK MYLAN 200MG EXTENDED + 300MG EXTENDED

AB AB AB AB AB AB AB AB AB AB AB AB

A084349 001 A084349 002 A040765 A040298 A040731 A040731 A040621 A040684 A040759 A040732 001 001 001 002 001 001 001 001 Nov Dec Jun Jun Dec Sep Dec Jan 12, 28, 30, 30, 11, 05, 18, 30, 2008 1998 2008 2008 2006 2006 2007 2008

A040298 002 A040298 003

Dec 06, 2001 Dec 06, 2001

INJECTABLE; INJECTION PHENYTOIN SODIUM AP + BAXTER HLTHCARE HOSPIRA AP AP LUITPOLD AP X-GEN PHARMS AP

50MG/ML 50MG/ML 50MG/ML 50MG/ML 50MG/ML

A084307 A089521 A089744 A040781 A040573

001 001 001 001 001

Mar Dec Dec Sep

17, 18, 04, 13,

1987 1987 2007 2006

PHYTONADIONE
INJECTABLE; INJECTION PHYTONADIONE BP INTL MEDICATION VITAMIN K1 BP + HOSPIRA VITAMIN K1 XX + HOSPIRA TABLET; ORAL

MEPHYTON

XX + BIOVAIL TECHNOLOGIES

1MG/0.5ML 1MG/0.5ML 10MG/ML

A083722 001 A087954 001 A087955 001 Jul 25, 1983 Jul 25, 1983

5MG

N010104 003

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

PILOCARPINE HYDROCHLORIDE

GEL; OPHTHALMIC

PILOPINE HS
XX + ALCON SOLUTION; OPHTHALMIC ISOPTO CARPINE ALCON RES XX XX XX +

3 - 336 (of 424)

4%

N018796 001

Oct 01, 1984

1% 2% 4%

N200890 001 N200890 002 N200890 003

Jun 22, 2010 Jun 22, 2010 Jun 22, 2010

AB AB AB AB AB AB AB AB AB

TABLET; ORAL PILOCARPINE HYDROCHLORIDE COREPHARMA 5MG IMPAX LABS 5MG 7.5MG LANNETT 5MG 7.5MG ROXANE 5MG 7.5MG SALAGEN EISAI INC 5MG + 7.5MG

A076746 A077248 A077248 A077220 A077220 A076963 A076963

001 001 002 001 002 001 002

Nov Mar Mar Oct May Dec Feb

16, 31, 31, 14, 06, 22, 27,

2004 2006 2006 2005 2009 2004 2007

N020237 001 N020237 002

Mar 22, 1994 Apr 18, 2003

PIMECROLIMUS

CREAM; TOPICAL

ELIDEL
XX + VALEANT INTL

1%

N021302 001

Dec 13, 2001

PIMOZIDE
TABLET; ORAL ORAP TEVA XX XX +

1MG 2MG

N017473 003 N017473 001

Aug 27, 1997 Jul 31, 1984

PINDOLOL
TABLET; ORAL PINDOLOL MYLAN AB AB + WATSON LABS AB AB

5MG 10MG 5MG 10MG

A074019 A074019 A074437 A074437

001 002 001 002

Sep Sep Feb Feb

03, 03, 27, 27,

1992 1992 1995 1995

PIOGLITAZONE HYDROCHLORIDE
TABLET; ORAL ACTOS TAKEDA PHARMS NA XX XX XX +

EQ 15MG BASE EQ 30MG BASE EQ 45MG BASE

N021073 001 N021073 002 N021073 003

Jul 15, 1999 Jul 15, 1999 Jul 15, 1999

PIPERACILLIN SODIUM

INJECTABLE; INJECTION

PIPERACILLIN
+ ISTITUTO BIOCHIMICO + + +

XX XX XX XX

EQ EQ EQ EQ

2GM BASE/VIAL 3GM BASE/VIAL 4GM BASE/VIAL 40GM BASE/VIAL

A065114 A065114 A065114 A065157

001 002 003 001

Nov Nov Nov Jul

14, 14, 14, 12,

2003 2003 2003 2004

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
INJECTABLE; INJECTION PIPERACILLIN AND TAZOBACTAM AUROBINDO PHARMA LTD EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL HOSPIRA INC EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL INSTITUTO BIOCHEMICO EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL SANDOZ EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL ZOSYN + WYETH PHARMS INC EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL + EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL + EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL + EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL ZOSYN IN PLASTIC CONTAINER + WYETH PHARMS INC EQ 40MG BASE/ML;EQ 5MG BASE/ML + EQ 60MG BASE/ML;EQ 7.5MG BASE/ML + EQ 4GM BASE/100ML;EQ 500MG BASE/100ML

3 - 337 (of 424)

AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP XX XX XX

A065498 A065498 A065498 A065386 A065386 A065386 A065446 A065523 A065523 A065523 A090498 A065362 A065363 A065362 A065363 A065362 A065363 N050684 N050684 N050684 N050684

001 002 003 001 002 003 001 001 002 003 001 001 001 002 002 003 003 001 002 003 004

May May May Sep Sep Sep Sep May May May May Oct Oct Oct Oct Oct Oct Oct Oct Oct Oct

23, 23, 23, 15, 15, 15, 15, 31, 31, 31, 31, 21, 21, 21, 21, 21, 21, 22, 22, 22, 22,

2011 2011 2011 2009 2009 2009 2009 2011 2011 2011 2011 2010 2010 2010 2010 2010 2010 1993 1993 1993 1993

N050750 001 N050750 002 N050750 003

Feb 24, 1998 Feb 24, 1998 Feb 24, 1998

PIRBUTEROL ACETATE

AEROSOL, METERED; INHALATION

MAXAIR
EQ 0.2MG BASE/INH XX + MEDICIS

N020014 001

Nov 30, 1992

PIROXICAM
CAPSULE; ORAL FELDENE PFIZER + PIROXICAM MUTUAL PHARM MYLAN NOSTRUM LABS TEVA WATSON LABS

AB AB AB AB AB AB AB AB AB AB AB AB AB

10MG 20MG 10MG 10MG 20MG 10MG 20MG 10MG 20MG 10MG 10MG 20MG 20MG

N018147 002 N018147 003 A073535 A074102 A074102 A074116 A074118 A074131 A074131 A074287 A074460 A074287 A074460 001 001 002 001 001 001 002 001 001 002 002

Apr 06, 1982 Apr 06, 1982 Mar Jul Jul Jun Jun Dec Dec May Sep May Sep 12, 31, 31, 15, 15, 11, 11, 16, 29, 16, 29, 1993 1992 1992 1993 1993 1992 1992 1996 1995 1996 1995

PITAVASTATIN CALCIUM
TABLET; ORAL LIVALO KOWA CO XX XX XX +

EQ 1MG BASE EQ 2MG BASE EQ 4MG BASE

N022363 001 N022363 002 N022363 003

Aug 03, 2009 Aug 03, 2009 Aug 03, 2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

PLERIXAFOR
SOLUTION; SUBCUTANEOUS
MOZOBIL
XX + GENZYME

3 - 338 (of 424)

24MG/1.2ML (20MG/ML)

N022311 001

Dec 15, 2008

PODOFILOX
GEL; TOPICAL
CONDYLOX
XX + WATSON PHARMS SOLUTION; TOPICAL CONDYLOX AT + WATSON PHARMS PODOFILOX PADDOCK LLC AT PRECISION DERMAT AT

0.5%

N020529 001

Mar 13, 1997

0.5% 0.5% 0.5%

N019795 001 A075600 001 A090184 001

Dec 13, 1990 Jan 29, 2002 Jul 21, 2010

POLIDOCANOL
SOLUTION; INTRAVENOUS ASCLERA CHEMISCH FBRK KRSSLR XX XX +

10MG/2ML (5MG/ML) 20MG/2ML (10MG/ML)

N021201 001 N021201 002

Mar 30, 2010 Mar 30, 2010

POLYETHYLENE GLYCOL 3350

FOR SOLUTION; ORAL GLYCOLAX KREMERS URBAN PHARMS 17GM/SCOOPFUL POLYETHYLENE GLYCOL 3350 BRECKENRIDGE PHARM 17GM/SCOOPFUL NEXGEN PHARMA INC 17GM/SCOOPFUL PADDOCK LLC 17GM/SCOOPFUL

AA AA AA AA

A076652 001 A077736 001 A077706 001 A077893 001

Jul 02, 2004 May 26, 2006 Sep 27, 2006 May 26, 2006

POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE

FOR SOLUTION; ORAL LAX-LYTE WITH FLAVOR PACKS PADDOCK LLC AA 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/ BOT NULYTELY AA + BRAINTREE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/ BOT NULYTELY-FLAVORED AA + BRAINTREE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/ BOT PEG-3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE MYLAN AA 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/ BOT NOVEL LABS INC AA 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/ BOT TRILYTE MEDA PHARMS AA 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/ BOT

A079232 001

Feb 25, 2010

N019797 001

Apr 22, 1991

N019797 002

Nov 18, 1994

A090409 001 A090019 001

Apr 02, 2010 May 27, 2009

A076491 001

Feb 05, 2004

POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE
FOR SOLUTION; ORAL CLENZ-LYTE PADDOCK LLC AA

236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/ BOT;22.74GM/BOT

A090769 001

Jun 07, 2010

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 339 (of 424)

POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS
FOR SOLUTION; ORAL COLYTE AA + MEDA PHARMS AA +

227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53G M/BOT;21.5GM/BOT 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/ BOT;22.72GM/BOT

N018983 010 N018983 007

Jan 31, 1989 Jun 12, 1987

AA

AA AA

AA

AA AA AA

AA

XX

COLYTE WITH FLAVOR PACKS + MEDA PHARMS 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/ BOT;22.72GM/BOT COLYTE-FLAVORED + MEDA PHARMS 227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53G M/BOT;21.5GM/BOT + 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/ BOT;22.72GM/BOT GOLYTELY + BRAINTREE 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/ BOT;22.74GM/BOT PEG 3350 AND ELECTROLYTES MYLAN 236GM;2.97GM;6.74GM;5.86GM;22.74GM NOVEL LABS INC 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/ BOT;22.74GM/BOT 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/ BOT;22.72GM/BOT POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES PADDOCK LLC 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/ BOT;22.72GM/BOT GOLYTELY + BRAINTREE 227.1GM/PACKET;2.82GM/PACKET;6.36GM/PAC KET;5.53GM/PACKET;21.5GM/PACKET

N018983 012

Oct 08, 1998

N018983 008 N018983 009

Nov 14, 1991 Nov 14, 1991

N019011 001

Jul 13, 1984

A090928 001 A090231 001 A090186 001

Jan 28, 2010 Jun 01, 2009 Jun 01, 2009

A090712 001

Feb 25, 2010

N019011 002

Jun 02, 1992

POLYMYXIN B SULFATE
INJECTABLE; INJECTION POLYMYCIN B SULFATE SAGENT STRIDES POLYMYXIN B SULFATE APP PHARMS + BEDFORD X GEN PHARMS

AP AP AP AP

EQ 500,000 UNITS BASE/VIAL EQ 500,000 U BASE/VIAL EQ 500,000 U BASE/VIAL EQ 500,000 U BASE/VIAL

A090110 001 A065372 001 A060716 001 A063000 001

Jun 29, 2011 Jan 10, 2008 Sep 30, 1994

POWDER; FOR RX COMPOUNDING

POLY-RX
100,000,000 UNITS/BOT XX + X GEN PHARMS

A061578 001

POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE

SOLUTION/DROPS; OPHTHALMIC POLYTRIM + ALLERGAN 10,000 UNITS/ML;EQ 1MG TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE BAUSCH AND LOMB 10,000 UNITS/ML;EQ 1MG FALCON PHARMS 10,000 UNITS/ML;EQ 1MG TAYLOR PHARMA 10,000 UNITS/ML;EQ 1MG

AT AT AT AT

BASE/ML BASE/ML BASE/ML BASE/ML

N050567 001 A064120 001 A064211 001 A065006 001

Oct 20, 1988 Feb 14, 1997 Apr 13, 1998 Dec 17, 1998

PORACTANT ALFA
SUSPENSION; INTRATRACHEAL
CUROSURF
XX + CORNERSTONE THERAP 80MG/ML

N020744 001

Nov 18, 1999

PORFIMER SODIUM
INJECTABLE; INJECTION PHOTOFRIN XX PINNACLE BIOLGS

75MG/VIAL

N020451 001

Dec 27, 1995

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

POSACONAZOLE
SUSPENSION; ORAL
NOXAFIL
XX + SCHERING

3 - 340 (of 424)

40MG/ML

N022003 001

Sep 15, 2006

POTASSIUM ACETATE
INJECTABLE; INJECTION
POTASSIUM ACETATE IN PLASTIC CONTAINER
2MEQ/ML XX + HOSPIRA

N018896 001

Jul 20, 1984

POTASSIUM CHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL MICRO-K NESHER PHARMS 8MEQ MICRO-K 10 NESHER PHARMS 10MEQ POTASSIUM CHLORIDE PADDOCK LLC 8MEQ 10MEQ WATSON LABS FLORIDA 8MEQ + 10MEQ INJECTABLE; INJECTION POTASSIUM CHLORIDE APP PHARMS 2MEQ/ML B BRAUN 2MEQ/ML BAXTER HLTHCARE 2MEQ/ML + HOSPIRA 2MEQ/ML INTL MEDICATION 2MEQ/ML POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER + BAXTER HLTHCARE 14.9MG/ML + 746MG/100ML HOSPIRA 14.9MG/ML 745MG/100ML POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER + BAXTER HLTHCARE 29.8MG/ML + 1.49GM/100ML + HOSPIRA 29.8MG/ML 1.49GM/100ML POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER + BAXTER HLTHCARE 2.24GM/100ML + HOSPIRA 2.24GM/100ML POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER + BAXTER HLTHCARE 2.98GM/100ML + HOSPIRA 2.98GM/100ML POTASSIUM CHLORIDE IN PLASTIC CONTAINER APP PHARMS 2MEQ/ML 2MEQ/ML POTASSIUM CHLORIDE + APP PHARMS 3MEQ/ML TABLET, EXTENDED RELEASE; KLOR-CON M10 UPSHER SMITH KLOR-CON M20 UPSHER SMITH POTASSIUM CHLORIDE EURAND NESHER PHARMS SCHERING + WATSON LABS FLORIDA ORAL 10MEQ 20MEQ 20MEQ 20MEQ 10MEQ 20MEQ 10MEQ A074726 002 A074726 001 A076368 A076044 N019439 N019439 A075604 001 001 002 001 001 Aug 09, 2000 Nov 20, 1998 Aug Apr Jun Jun Apr 18, 05, 13, 13, 10, 2004 2002 1986 1986 2002

AB AB AB AB AB AB

N018238 001 N018238 002 A200185 A200185 A077419 A077419 001 002 001 002 May 14, 1984 May May Jun Jun 18, 18, 02, 02, 2011 2011 2008 2008

AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP XX

A080225 A085870 A085499 A080205 A083163 N019904 N019904 N020161 N020161 N019904 N019904 N020161 N020161

001 001 001 001 001 001 005 005 001 002 006 006 002 Dec Dec Nov Nov Dec Dec Aug Nov 26, 17, 30, 30, 26, 17, 11, 30, 1989 1990 1992 1992 1989 1990 1998 1992

N019904 003 N020161 003 N019904 004 N020161 004 A088901 001 A088908 001 A080225 003

Dec 26, 1989 Aug 11, 1998 Dec 26, 1989 Aug 11, 1998 Jan 25, 1985 Jan 25, 1985

AB AB AB AB AB AB AB

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

POTASSIUM CHLORIDE
TABLET, EXTENDED RELEASE; POTASSIUM CHLORIDE WATSON LABS FLORIDA K+10 FUTURE PAK KAON CL-10 SAVAGE LABS KLOR-CON UPSHER-SMITH LABS + KLOTRIX APOTHECON K-TAB ABBOTT POTASSIUM CHLORIDE ABBOTT KLOR-CON M15 UPSHER SMITH ORAL 20MEQ 10MEQ 10MEQ 8MEQ 10MEQ 10MEQ 10MEQ 8MEQ 15MEQ

3 - 341 (of 424)

AB BC BC BC BC BC BC BC XX

A075604 002 A070999 001 N017046 002 N019123 001 N019123 002 N017850 001 N018279 001 N018279 002 A074726 003

Apr 10, 2002 Oct 22, 1987

Apr 17, 1986 Apr 17, 1986

Aug 01, 1988 Jun 06, 2003

POTASSIUM CHLORIDE; SODIUM CHLORIDE

INJECTABLE; INJECTION POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER HOSPIRA 149MG/100ML;450MG/100ML A078446 POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER + BAXTER HLTHCARE 150MG/100ML;450MG/100ML N017648 POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER B BRAUN 150MG/100ML;900MG/100ML N019708 BAXTER HLTHCARE 150MG/100ML;900MG/100ML N017648 POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER BAXTER HLTHCARE 300MG/100ML;900MG/100ML N017648 POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HOSPIRA 149MG/100ML;900MG/100ML N019686 POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HOSPIRA 298MG/100ML;900MG/100ML N019686 POTASSIUM CHLORIDE 0.224% IN SODIUM CHLORIDE 0.9% BAXTER HLTHCARE 224MG/100ML;900MG/100ML N017648

AP AP AP AP AP AP AP XX

001 005 004 001 002 001 002 003

Sep 10, 2008 Nov 26, 2002 Sep 29, 1989

Oct 17, 1988 Oct 17, 1988

POTASSIUM CITRATE
TABLET, EXTENDED RELEASE; ORAL POTASSIUM CITRATE COREPHARMA AB 5MEQ AB 10MEQ UROCIT-K MISSION PHARMA AB 5MEQ AB 10MEQ UROCIT-K 15MEQ XX + MISSION PHARMA

A077440 001 A077440 002 N019071 001 N019071 002 N019071 003

Jun 09, 2006 Jun 09, 2006 Aug 30, 1985 Aug 31, 1992 Dec 30, 2009

POVIDONE-IODINE
SOLUTION/DROPS; OPHTHALMIC
BETADINE
XX + ALCON PHARMS LTD 5%

N018634 001

Dec 17, 1986

PRALATREXATE
SOLUTION; INTRAVENOUS FOLOTYN ALLOS XX XX +

20MG/ML (20MG/ML) 40MG/2ML (20MG/ML)

N022468 001 N022468 002

Sep 24, 2009 Sep 24, 2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

PRALIDOXIME CHLORIDE
INJECTABLE; INJECTION

PRALIDOXIME CHLORIDE

XX + MERIDIAN MEDCL TECHN PROTOPAM CHLORIDE XX + BAXTER HLTHCARE CORP

3 - 342 (of 424)

300MG/ML 1GM/VIAL

N018986 001 N014134 001

Apr 26, 1983

PRAMIPEXOLE DIHYDROCHLORIDE
TABLET; ORAL MIRAPEX BOEHRINGER INGELHEIM 0.125MG AB AB + 0.25MG AB 0.5MG AB 0.75MG AB 1MG AB 1.5MG PRAMIPEXOLE DIHYDROCHLORIDE ACTAVIS PHARMA AB 0.125MG AB 0.25MG AB 0.5MG AB 0.75MG AB 1MG AB 1.5MG ALEMBIC LTD AB 0.125MG AB 0.25MG AB 0.5MG AB 1MG AB 1.5MG BARR AB 0.125MG AB 0.25MG AB 0.5MG AB 1MG AB 1.5MG BRECKENRIDGE PHARM AB 0.125MG AB 0.25MG AB 0.5MG AB 1MG AB 1.5MG GLENMARK GENERICS AB 0.125MG AB 0.25MG AB 0.5MG AB 1MG AB 1.5MG MYLAN AB 0.125MG AB 0.25MG AB 0.5MG AB 0.75MG AB 1MG AB 1.5MG SANDOZ AB 0.125MG AB 0.25MG AB 0.5MG AB 0.75MG AB 1MG AB 1.5MG TEVA PHARMS AB 0.125MG AB 0.25MG AB 0.5MG AB 0.75MG AB 1MG

N020667 N020667 N020667 N020667 N020667 N020667 A091254 A091254 A091254 A091254 A091254 A091254 A078894 A078894 A078894 A078894 A078894 A077724 A077724 A077724 A077724 A077724 A091450 A091450 A091450 A091450 A091450 A090781 A090781 A090781 A090781 A090781 A077854 A077854 A077854 A090764 A077854 A077854 A090190 A090190 A090190 A090190 A090190 A090190 A090241 A090241 A090241 A090241 A090241

001 002 006 007 003 005 001 002 003 004 005 006 001 002 003 004 005 001 002 003 004 005 001 002 003 004 005 001 002 003 004 005 001 002 003 001 004 005 001 002 003 006 004 005 001 002 003 004 005

Jul Jul Feb Jul Jul Jul Nov Nov Nov Nov Nov Nov Oct Oct Oct Oct Oct Feb Feb Feb Feb Feb Oct Oct Oct Oct Oct Oct Oct Oct Oct Oct Oct Oct Oct Apr Oct Oct Jul Jul Jul Oct Jul Jul Oct Oct Oct Oct Oct

01, 01, 12, 30, 01, 01, 30, 30, 30, 30, 30, 30, 08, 08, 08, 08, 08, 19, 19, 19, 19, 19, 08, 08, 08, 08, 08, 08, 08, 08, 08, 08, 08, 08, 08, 09, 08, 08, 06, 06, 06, 08, 06, 06, 08, 08, 08, 08, 08,

1997 1997 1998 2007 1997 1997 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2008 2008 2008 2008 2008 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

PRAMIPEXOLE DIHYDROCHLORIDE
TABLET; ORAL PRAMIPEXOLE DIHYDROCHLORIDE TEVA PHARMS 1.5MG TORRENT PHARMS 0.125MG 0.25MG 0.5MG 0.75MG 1MG 1.5MG WATSON LABS 0.125MG 0.25MG 0.5MG 1MG 1.5MG ZYDUS PHARMS USA INC 0.125MG 0.25MG 0.5MG 1MG 1.5MG

3 - 343 (of 424)

AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB

A090241 A090865 A090865 A090865 A090865 A090865 A090865 A078551 A078551 A078551 A078551 A078551 A078920 A078920 A078920 A078920 A078920

006 001 002 003 004 005 006 001 002 003 004 005 001 002 003 004 005

Oct Oct Oct Oct Oct Oct Oct Oct Oct Oct Oct Oct Jul Jul Jul Jul Jul

08, 08, 08, 08, 08, 08, 08, 08, 08, 08, 08, 08, 06, 06, 06, 06, 06,

2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010

TABLET, EXTENDED RELEASE; ORAL

MIRAPEX ER

XX + BOEHRINGER INGELHEIM 0.375MG 0.75MG XX 1.5MG XX 2.25MG XX 3MG XX 3.75MG XX 4.5MG XX

N022421 N022421 N022421 N022421 N022421 N022421 N022421

001 002 003 006 004 007 005

Feb Feb Feb Jun Feb Jun Feb

19, 19, 19, 17, 19, 17, 19,

2010 2010 2010 2011 2010 2011 2010

PRAMLINTIDE ACETATE
INJECTABLE; SUBCUTANEOUS SYMLIN XX AMYLIN XX XX +

EQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML) EQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML) EQ 3MG BASE/5ML (EQ 600MCG BASE/ML)

N021332 002 N021332 003 N021332 001

Sep 25, 2007 Sep 25, 2007 Mar 16, 2005

PRASUGREL HYDROCHLORIDE
TABLET; ORAL EFFIENT ELI LILLY AND CO XX XX +

EQ 5MG BASE EQ 10MG BASE

N022307 001 N022307 002

Jul 10, 2009 Jul 10, 2009

PRAVASTATIN SODIUM
TABLET; ORAL PRAVACHOL BRISTOL MYERS SQUIBB AB AB AB AB + PRAVASTATIN SODIUM APOTEX AB AB AB AB DR REDDYS LABS INC AB AB AB AB GLENMARK GENERICS AB

10MG 20MG 40MG 80MG 10MG 20MG 40MG 80MG 10MG 20MG 40MG 80MG 10MG

N019898 N019898 N019898 N019898 A076341 A076341 A076341 A076341 A076714 A076714 A076714 A076714 A077987

002 003 004 008 001 002 003 004 001 002 003 004 001

Oct Oct Mar Dec Oct Oct Oct Dec Oct Oct Oct Dec May

31, 31, 22, 18, 23, 23, 23, 28, 23, 23, 23, 28, 11,

1991 1991 1993 2001 2006 2006 2006 2007 2006 2006 2006 2007 2007

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

PRAVASTATIN SODIUM
TABLET; ORAL PRAVASTATIN SODIUM GLENMARK GENERICS AB AB AB LEK PHARMS DD AB AB AB AB LUPIN PHARMS AB AB AB AB MATRIX LABS LTD AB AB AB AB MYLAN AB AB AB AB PLIVA HRVATSKA DOO AB AB AB RANBAXY AB AB AB AB TEVA AB AB AB TEVA PHARMS AB WATSON LABS AB AB AB AB AB AB AB ZYDUS PHARMS USA AB AB AB AB PRAVASTATIN SODIUM PLIVA HRVATSKA DOO XX

3 - 344 (of 424)

20MG 40MG 80MG 10MG 20MG 40MG 80MG 10MG 20MG 40MG 80MG 10MG 20MG 40MG 80MG 10MG 20MG 40MG 80MG 10MG 20MG 40MG 10MG 20MG 40MG 80MG 10MG 20MG 40MG 80MG 10MG 10MG 20MG 20MG 40MG 40MG 80MG 10MG 20MG 40MG 80MG 30MG

A077987 A077987 A077987 A076397 A076397 A076397 A077491 A077917 A077917 A077917 A077917 A079187 A079187 A079187 A079187 A077013 A077013 A077013 A077013 A077730 A077730 A077730 A076445 A076445 A076445 A076445 A076056 A076056 A076056 A077793 A076939 A077904 A076939 A077904 A076939 A077904 A076939 A077751 A077751 A077751 A077751

002 003 004 003 002 001 001 001 002 003 004 001 002 003 004 001 002 003 004 001 002 005 001 002 003 004 001 002 003 001 004 001 003 002 002 003 001 001 002 003 004

May May Dec Oct Oct Oct Feb Jan Jan Jan Jan May May May May Oct Oct Oct Dec Nov Nov Nov Apr Apr Apr Apr Apr Apr Apr Jan Oct Oct Oct Oct Oct Oct Dec Apr Apr Apr Apr

11, 11, 28, 23, 23, 23, 11, 08, 08, 08, 08, 27, 27, 27, 27, 23, 23, 23, 28, 21, 21, 21, 23, 23, 23, 23, 24, 24, 24, 15, 23, 23, 23, 23, 23, 23, 28, 30, 30, 30, 30,

2007 2007 2007 2006 2006 2006 2008 2008 2008 2008 2008 2010 2010 2010 2010 2006 2006 2006 2007 2006 2006 2006 2007 2007 2007 2007 2006 2006 2006 2008 2006 2006 2006 2006 2006 2006 2007 2008 2008 2008 2008

A077730 003

Nov 21, 2006

PRAZIQUANTEL
TABLET; ORAL

BILTRICIDE

XX + BAYER PHARMA AG

600MG

N018714 001

Dec 29, 1982

PRAZOSIN HYDROCHLORIDE
CAPSULE; ORAL MINIPRESS PFIZER AB AB + AB PRAZOSIN HYDROCHLORIDE IVAX SUB TEVA PHARMS AB

EQ 1MG BASE EQ 2MG BASE EQ 5MG BASE EQ 1MG BASE

N017442 002 N017442 003 N017442 001 A071994 001 Sep 12, 1988

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

PRAZOSIN HYDROCHLORIDE
CAPSULE; ORAL PRAZOSIN HYDROCHLORIDE IVAX SUB TEVA PHARMS AB AB MYLAN AB AB AB

3 - 345 (of 424)

EQ EQ EQ EQ EQ

2MG 5MG 1MG 2MG 5MG

BASE BASE BASE BASE BASE

A071995 A071745 A072575 A072575 A072575

001 001 003 002 001

Sep Sep May May May

12, 12, 16, 16, 16,

1988 1988 1989 1989 1989

PREDNICARBATE
CREAM; TOPICAL DERMATOP E EMOLLIENT AB + SANOFI AVENTIS US PREDNICARBATE ALTANA AB OINTMENT; TOPICAL DERMATOP AB + SANOFI AVENTIS US PREDNICARBATE ALTANA AB

0.1% 0.1%

N020279 001 A077287 001

Oct 29, 1993 Sep 19, 2006

0.1% 0.1%

N019568 001 A077236 001

Sep 23, 1991 Mar 09, 2007

PREDNISOLONE
SYRUP; ORAL PREDNISOLONE ALPHARMA AA APOTEX INC AA AA HI TECH PHARMA AA AA + NESHER PHARMS AA + PHARM ASSOC AA VINTAGE AA WOCKHARDT AA PRELONE TEVA AA TABLET; ORAL

PREDNISOLONE

XX + WATSON LABS

15MG/5ML 5MG/5ML 15MG/5ML 15MG/5ML 5MG/5ML 15MG/5ML 15MG/5ML 15MG/5ML 15MG/5ML 15MG/5ML

A040323 A040570 A040571 A040401 A040423 A040364 A040399 A040775 A040313

001 001 001 001 001 001 001 001 001

May Aug Aug Feb Oct Apr Mar Sep Sep

13, 25, 25, 27, 22, 10, 05, 21, 10,

1999 2005 2005 2003 2001 2002 2003 2007 2003

A089081 001

Feb 04, 1986

5MG

A080354 001

PREDNISOLONE ACETATE
SUSPENSION; ORAL

FLO-PRED

XX + TARO

EQ 15MG BASE/5ML

N022067 002

Jan 17, 2008

SUSPENSION/DROPS; OPHTHALMIC OMNIPRED ALCON AB 1% PRED FORTE AB + ALLERGAN 1% PRED MILD 0.12% XX + ALLERGAN

N017469 001 N017011 001 N017100 001

PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM

OINTMENT; OPHTHALMIC

BLEPHAMIDE S.O.P.
XX + ALLERGAN
SUSPENSION; OPHTHALMIC

BLEPHAMIDE
XX + ALLERGAN

0.2%;10%

A087748 001

Dec 03, 1986

0.2%;10%

N012813 002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

PREDNISOLONE SODIUM PHOSPHATE
SOLUTION; ORAL ORAPRED + SHIONOGI INC EQ 15MG BASE/5ML PEDIAPRED + UCB INC EQ 5MG BASE/5ML PREDNISOLONE SODIUM PHOSPHATE AMNEAL PHARMS EQ 15MG BASE/5ML HI TECH PHARMA EQ 5MG BASE/5ML NESHER PHARMS EQ 5MG BASE/5ML EQ 15MG BASE/5ML PADDOCK LLC EQ 5MG BASE/5ML PHARM ASSOC EQ 5MG BASE/5ML EQ 15MG BASE/5ML VINTAGE EQ 15MG BASE/5ML WE PHARMS EQ 15MG BASE/5ML WOCKHARDT EQ 5MG BASE/5ML EQ 15MG BASE/5ML PREDNISOLONE SODIUM PHOSPHATE + PHARM ASSOC EQ 10MG BASE/5ML + EQ 20MG BASE/5ML + EQ 25MG BASE/5ML

3 - 346 (of 424)

AA AA AA AA AA AA AA AA AA AA AA AA AA XX XX XX

A075117 001 N019157 001 A078345 A075183 A076982 A076988 A075988 A076123 A076913 A079010 A075250 A075099 A076895 001 001 001 001 001 001 001 001 001 001 001

Dec 14, 2000 May 28, 1986 Mar Mar May May May Dec Apr May Jul Jun Oct 10, 26, 24, 24, 25, 23, 25, 26, 12, 28, 04, 2009 2003 2005 2005 2004 2002 2005 2009 2002 2002 2004

A078465 001 A078988 001 A091396 001

Mar 07, 2008 Jun 09, 2008 Sep 13, 2010

SOLUTION/DROPS; OPHTHALMIC
PREDNISOLONE SODIUM PHOSPHATE
XX + BAUSCH AND LOMB EQ 0.9% PHOSPHATE TABLET, ORALLY DISINTEGRATING; ORAL ORAPRED ODT XX SHIONOGI INC EQ 10MG BASE XX EQ 15MG BASE XX + EQ 30MG BASE

A040070 001

Jul 29, 1994

N021959 001 N021959 002 N021959 003

Jun 01, 2006 Jun 01, 2006 Jun 01, 2006

PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM

SOLUTION/DROPS; OPHTHALMIC SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE ALCON PHARMS LTD AT EQ 0.23% PHOSPHATE;10% BAUSCH AND LOMB AT EQ 0.23% PHOSPHATE;10% VASOCIDIN AT + NOVARTIS EQ 0.23% PHOSPHATE;10%

A073630 001 A074449 001 N018988 001

May 27, 1993 Dec 29, 1995 Aug 26, 1988

PREDNISONE
SOLUTION; ORAL

PREDNISONE

XX + ROXANE PREDNISONE INTENSOL XX + ROXANE TABLET; ORAL PREDNISONE CONTRACT PHARMACAL AB JUBILANT CADISTA AB AB AB AB MUTUAL PHARM AB AB AB AB + ROXANE AB + AB + AB +

5MG/5ML 5MG/ML

A088703 001 A088810 001

Nov 08, 1984 Feb 20, 1985

5MG 1MG 5MG 10MG 20MG 5MG 10MG 20MG 1MG 2.5MG 5MG 10MG

A080209 A040611 A040362 A040362 A040362 A089245 A089246 A089247 A087800 A087801 A080352 A084122

001 001 002 001 003 001 001 001 001 001 001 001

Jun Aug Aug Jun Dec Dec Dec Apr Apr

06, 29, 29, 29, 04, 04, 04, 22, 22,

2005 2001 2001 2005 1985 1985 1985 1982 1982

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

PREDNISONE
TABLET; ORAL PREDNISONE AB + ROXANE AB + VINTAGE PHARMS AB AB AB AB AB WATSON LABS AB AB AB WEST WARD AB AB AB AB WEST WARD PHARM CORP AB

3 - 347 (of 424)

20MG 50MG 1MG 2.5MG 5MG 10MG 20MG 5MG 10MG 20MG 2.5MG 5MG 10MG 20MG 1MG

A087342 A084283 A040584 A040581 A040256 A040256 A040392 A080356 A085162 A085161 A040538 A080292 A088832 A083677 A040890

001 001 001 001 001 002 001 001 001 001 001 001 001 001 001

Dec Dec Jul Jul Feb

21, 21, 12, 12, 12,

2004 2004 2002 2002 2003

Jan 08, 2004 Dec 04, 1985 Nov 01, 2010

PREGABALIN
CAPSULE; ORAL LYRICA CPPI CV XX XX XX XX XX XX XX XX +
SOLUTION; ORAL

LYRICA
XX + CPPI CV

25MG 50MG 75MG 100MG 150MG 200MG 225MG 300MG

N021446 N021446 N021446 N021446 N021446 N021446 N021446 N021446

001 002 003 004 005 006 007 008

Dec Dec Dec Dec Dec Dec Dec Dec

30, 30, 30, 30, 30, 30, 30, 30,

2004 2004 2004 2004 2004 2004 2004 2004

20MG/ML

N022488 001

Jan 04, 2010

PRILOCAINE HYDROCHLORIDE
INJECTABLE; INJECTION CITANEST PLAIN DENTAL AP + DENTSPLY PHARM 4% PRILOCAINE HYDROCHLORIDE SEPTODONT INC AP 4%

N021382 001 A079235 001 Sep 29, 2010

PRIMAQUINE PHOSPHATE
TABLET; ORAL

PRIMAQUINE

XX + SANOFI AVENTIS US

EQ 15MG BASE

N008316 001

PRIMIDONE
TABLET; ORAL MYSOLINE AB + VALEANT AB PRIMIDONE AMNEAL PHARM AB AB DR REDDYS LABS LTD AB AB IMPAX LABS AB AB LANNETT AB

50MG 250MG 50MG 250MG 50MG 250MG 50MG 250MG 50MG

N009170 003 N009170 002 A040866 A040866 A040862 A040862 A040717 A040717 A084903 001 002 001 002 001 002 002 Apr Apr Oct Oct Feb Feb May 23, 23, 03, 03, 12, 12, 24, 2008 2008 2008 2008 2008 2008 2001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

PRIMIDONE
TABLET; ORAL PRIMIDONE LANNETT AB MUTUAL PHARM AB AB VINTAGE PHARMS AB AB WATSON LABS AB WEST WARD AB AB

3 - 348 (of 424)

250MG 50MG 250MG 50MG 250MG 250MG 50MG 250MG

A084903 A040626 A040626 A040586 A040586 A083551 A040667 A040667

001 001 002 001 002 001 001 002

Sep Sep Feb Feb

29, 29, 24, 24,

2005 2005 2005 2005

Jul 27, 2006 Jul 27, 2006

PROBENECID
TABLET; ORAL PROBALAN LANNETT PROBENECID IVAX SUB TEVA PHARMS + MYLAN WATSON LABS

AB AB AB AB

500MG 500MG 500MG 500MG

A080966 001 A083740 001 A084211 002 A084442 004 May 09, 1984 Mar 29, 1983

PROCAINAMIDE HYDROCHLORIDE
INJECTABLE; INJECTION PROCAINAMIDE HYDROCHLORIDE + HOSPIRA 100MG/ML + 500MG/ML INTL MEDICATION 100MG/ML 500MG/ML

AP AP AP AP

A089069 A089070 A088636 A088637

001 001 001 001

Feb Feb Jul Jul

12, 12, 31, 31,

1986 1986 1984 1984

PROCARBAZINE HYDROCHLORIDE
CAPSULE; ORAL
MATULANE
XX + SIGMA TAU

EQ 50MG BASE

N016785 001

PROCHLORPERAZINE
SUPPOSITORY; RECTAL COMPRO PADDOCK LLC AB PROCHLORPERAZINE AB + G AND W LABS

25MG 25MG

A040246 001 A040058 001

Jun 28, 2000 Nov 24, 1993

PROCHLORPERAZINE EDISYLATE
INJECTABLE; INJECTION PROCHLORPERAZINE EDISYLATE AP + BAXTER HLTHCARE EQ 5MG BASE/ML BEDFORD AP EQ 5MG BASE/ML

A089903 001 A040540 001

Aug 29, 1989 May 28, 2004

PROCHLORPERAZINE MALEATE
TABLET; ORAL PROCHLORPERAZINE MALEATE MYLAN AB EQ AB EQ SANDOZ AB EQ AB + EQ TEVA PHARMS AB EQ AB EQ PROCOMP JUBILANT CADISTA AB EQ AB EQ

5MG BASE 10MG BASE 5MG BASE 10MG BASE 5MG BASE 10MG BASE 5MG BASE 10MG BASE

A040185 A040185 A040101 A040101 A040120 A040120

002 001 001 002 001 002

Oct Oct Jul Jul Jul Jul

28, 28, 19, 19, 11, 11,

1996 1996 1996 1996 1996 1996

A040268 001 A040268 002

Feb 27, 1998 Feb 27, 1998

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

PROGESTERONE
CAPSULE; ORAL PROMETRIUM ABBOTT LABS XX XX + GEL; VAGINAL CRINONE WATSON LABS XX XX + INJECTABLE; INJECTION PROGESTERONE APP PHARMS HIKMA FARMACEUTICA LUITPOLD + WATSON LABS (UTAH)

3 - 349 (of 424)

100MG 200MG

N019781 001 N019781 002

May 14, 1998 Oct 15, 1999

4% 8%

N020701 001 N020701 002

Jul 31, 1997 Jul 31, 1997

AO AO AO AO

50MG/ML 50MG/ML 50MG/ML 50MG/ML

A075906 A091033 A090845 N017362

001 001 001 002

Apr 25, 2001 Oct 28, 2010 Jun 22, 2009

INSERT; VAGINAL

ENDOMETRIN

XX + FERRING

100MG

N022057 001

Jun 21, 2007

PROMETHAZINE HYDROCHLORIDE
INJECTABLE; INJECTION PROMETHAZINE HYDROCHLORIDE BAXTER HLTHCARE 25MG/ML 50MG/ML HOSPIRA 25MG/ML LUITPOLD 25MG/ML + TEVA PARENTERAL 25MG/ML + 50MG/ML WOCKHARDT 25MG/ML 50MG/ML X-GEN PHARMS 25MG/ML 50MG/ML SUPPOSITORY; RECTAL PROMETHAZINE HYDROCHLORIDE G AND W LABS 12.5MG + 25MG PADDOCK LLC 12.5MG 25MG PERRIGO NEW YORK 12.5MG 25MG TARO 12.5MG 25MG PROMETHEGAN + G AND W LABS 50MG SYRUP; ORAL PROMETHAZINE HYDROCHLORIDE AMNEAL PHARMS 6.25MG/5ML HI TECH PHARMA 6.25MG/5ML SUN PHARM INDS INC 6.25MG/5ML TARO 6.25MG/5ML VINTAGE 6.25MG/5ML PROMETHAZINE PLAIN + WOCKHARDT 6.25MG/5ML TABLET; ORAL PROMETHAZINE HYDROCHLORIDE AMNEAL PHARMS NY 12.5MG 25MG 50MG EMCURE PHARMS USA 12.5MG

AP AP AP AP AP AP AP AP AP AP

A083312 A083312 A040372 A040515 A040454 A040454 A040785 A040785 A040737 A040737

001 002 001 001 001 002 001 002 001 002

Jun Mar Aug Aug Sep Sep Apr Apr

08, 19, 22, 22, 26, 26, 24, 24,

2000 2003 2002 2002 2008 2008 2008 2008

AB AB AB AB AB AB AB AB XX

A040428 A040428 A040479 A040479 A040500 A040500 A040603 A040603

002 001 001 002 001 002 001 002

Mar Feb Jun Jun Jun Jun Oct Oct

31, 05, 24, 24, 30, 30, 26, 26,

2003 2002 2003 2003 2003 2003 2006 2006

A087165 001

Aug 14, 1987

AA AA AA AA AA AA

A040882 A040026 A040891 A040718 A040643

001 001 001 001 001

Dec Sep Mar Apr Apr

30, 25, 13, 04, 26,

2009 1998 2009 2007 2006

A087953 001

Nov 15, 1982

AB AB AB AB

A091179 A091179 A091179 A040673

001 002 003 001

Dec Dec Dec Mar

13, 13, 13, 05,

2010 2010 2010 2008

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

PROMETHAZINE HYDROCHLORIDE
TABLET; ORAL PROMETHAZINE HYDROCHLORIDE EMCURE PHARMS USA 25MG 50MG IMPAX LABS 12.5MG 25MG 50MG KVK TECH 12.5MG 25MG 50MG MYLAN 12.5MG 25MG 50MG SANDOZ 25MG + 50MG SUN PHARM INDS INC 12.5MG 25MG 50MG VINTAGE PHARMS 12.5MG 25MG 50MG WATSON LABS 25MG 50MG ZYDUS PHARMS USA 12.5MG 25MG 50MG

3 - 350 (of 424)

AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB

A040673 A040673 A040724 A040724 A040791 A040712 A040712 A040713 A091054 A091054 A091054 A084234 A084176 A040863 A040863 A040863 A040622 A040622 A040622 A083426 A083711 A040596 A040596 A040596

002 003 001 002 001 002 001 001 001 002 003 001 001 001 002 003 001 002 003 001 001 001 002 003

Mar Mar Feb Feb May May Jul Jul Aug Aug Aug

05, 05, 12, 12, 20, 04, 31, 31, 30, 30, 30,

2008 2008 2008 2008 2008 2007 2006 2006 2011 2011 2011

Dec Dec Dec Jul Jul Jul

30, 30, 30, 18, 18, 18,

2008 2008 2008 2006 2006 2006

Nov 18, 2005 Nov 18, 2005 Nov 18, 2005

PROPAFENONE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL PROPAFENONE HYDROCHLORIDE PAR PHARM 225MG 325MG 425MG RYTHMOL SR GLAXOSMITHKLINE LLC 225MG 325MG + 425MG TABLET; ORAL PROPAFENONE HYDROCHLORIDE MUTUAL PHARM 150MG 225MG 300MG NESHER PHARMS 150MG 225MG 300MG PLIVA 150MG 225MG 300MG VINTAGE PHARMS 150MG 225MG 300MG WATSON LABS 150MG 225MG RYTHMOL GLAXOSMITHKLINE LLC 150MG 225MG + 300MG

AB AB AB AB AB AB

A078540 001 A078540 002 A078540 003 N021416 001 N021416 002 N021416 003

Oct 18, 2010 Oct 18, 2010 Oct 18, 2010 Sep 04, 2003 Sep 04, 2003 Sep 04, 2003

AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB

A075998 A075998 A075998 A076193 A076193 A076193 A076550 A076550 A076550 A075938 A075938 A075938 A075203 A075203

001 002 003 001 002 003 001 002 003 001 002 003 001 002

Nov Nov Nov Feb Feb Feb Apr Apr Apr Oct Oct Oct Oct Oct

29, 29, 29, 07, 07, 07, 23, 23, 23, 17, 17, 17, 24, 24,

2001 2001 2001 2002 2002 2002 2004 2004 2004 2002 2002 2002 2000 2000

N019151 001 N019151 003 N019151 002

Nov 27, 1989 Nov 20, 1992 Nov 27, 1989

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

PROPANTHELINE BROMIDE
TABLET; ORAL

PROPANTHELINE BROMIDE

XX + ROXANE

3 - 351 (of 424)

15MG

A080927 002

PROPARACAINE HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC ALCAINE ALCON 0.5% OPHTHAINE + APOTHECON 0.5% OPHTHETIC + ALLERGAN 0.5% PROPARACAINE HYDROCHLORIDE BAUSCH AND LOMB 0.5% TAYLOR PHARMA 0.5%

AT AT AT AT AT

A080027 001 N008883 001 N012583 001 A040074 001 A040277 001 Sep 29, 1995 Mar 16, 2000

PROPOFOL
INJECTABLE; INJECTION DIPRIVAN AB + APP PHARMS PROPOFOL HOSPIRA AB TEVA PARENTERAL AB

10MG/ML 10MG/ML 10MG/ML

N019627 002 A077908 001 A075102 001

Jun 11, 1996 Mar 17, 2006 Jan 04, 1999

PROPRANOLOL HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL INDERAL LA AKRIMAX PHARMS 60MG 80MG 120MG + 160MG PROPRANOLOL HYDROCHLORIDE ACTAVIS ELIZABETH 60MG 80MG 120MG 160MG GLAXOSMITHKLINE 60MG 80MG 120MG 160MG MYLAN 60MG 80MG 120MG 160MG PAR PHARM 60MG 80MG 120MG 160MG UPSHER SMITH 60MG 80MG 120MG 160MG ZYDUS PHARMS USA INC 60MG 80MG 120MG 160MG INNOPRAN XL GLAXOSMITHKLINE LLC 80MG 120MG

AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB BX BX

N018553 N018553 N018553 N018553 A078494 A078494 A078494 A078494 A078703 A078703 A078703 A078703 A078022 A078022 A078022 A078022 A078065 A078065 A078065 A078065 A078311 A078311 A078311 A078311 A090321 A090321 A090321 A090321

004 002 003 001 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004

Mar Apr Apr Apr Aug Aug Aug Aug Jul Jul Jul Jul Feb Feb Feb Feb Jan Jan Jan Jan Mar Mar Mar Mar Mar Mar Mar Mar

18, 19, 19, 19, 10, 10, 10, 10, 15, 15, 15, 15, 15, 15, 15, 15, 26, 26, 26, 26, 06, 06, 06, 06, 25, 25, 25, 25,

1987 1983 1983 1983 2007 2007 2007 2007 2011 2011 2011 2011 2007 2007 2007 2007 2007 2007 2007 2007 2009 2009 2009 2009 2011 2011 2011 2011

N021438 001 N021438 002

Mar 12, 2003 Mar 12, 2003

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

PROPRANOLOL HYDROCHLORIDE
INJECTABLE; INJECTION PROPRANOLOL HYDROCHLORIDE APP PHARMS 1MG/ML + BAXTER HLTHCARE CORP 1MG/ML BEDFORD 1MG/ML HIKMA FARMACEUTICA 1MG/ML SANDOZ 1MG/ML

3 - 352 (of 424)

AP AP AP AP AP

A075826 N016419 A075792 A077760 A076400

001 001 001 001 001

Aug 31, 2001 Aug 29, 2000 Jan 31, 2008 Feb 26, 2003

SOLUTION; ORAL

PROPRANOLOL HYDROCHLORIDE

20MG/5ML XX + ROXANE 40MG/5ML XX + TABLET; ORAL INDERAL AKRIMAX PHARMS AB 40MG AB 60MG AB + 80MG PROPRANOLOL HYDROCHLORIDE IPCA LABS LTD AB 10MG AB 20MG AB 40MG AB 60MG AB 80MG MYLAN AB 10MG AB 20MG AB 40MG AB 60MG AB 80MG NORTHSTAR HLTHCARE AB 10MG AB 20MG AB 40MG AB 60MG AB 80MG PLIVA AB 10MG AB 20MG AB 40MG AB 60MG AB + 80MG VINTAGE PHARMS AB 10MG AB 20MG AB 40MG AB 60MG AB 80MG WATSON LABS AB 10MG AB 20MG AB 40MG AB 80MG

A070979 001 A070690 001

May 15, 1987 May 15, 1987

N016418 002 N016418 009 N016418 004 A078955 A078955 A078955 A078955 A078955 A070213 A070213 A070213 A070213 A070213 A078213 A078213 A078213 A078213 A078213 A071972 A071973 A071974 A071975 A071976 A070217 A070218 A070219 A070220 A070221 A070175 A070176 A070177 A070178 001 002 003 004 005 002 003 001 005 004 001 002 003 004 005 001 001 001 001 001 001 001 001 001 001 001 001 001 001

Oct 18, 1982

Jun Jun Jun Jun Jun Nov Nov Nov Apr Nov Jan Jan Jan Jan Jan Apr Apr Apr Apr Apr Aug Aug Aug Sep Apr May May May May

02, 02, 02, 02, 02, 19, 19, 19, 08, 19, 10, 10, 10, 10, 10, 06, 06, 06, 06, 06, 01, 01, 01, 24, 14, 13, 13, 13, 13,

2008 2008 2008 2008 2008 1985 1985 1985 2011 1985 2008 2008 2008 2008 2008 1988 1988 1988 1988 1988 1986 1986 1986 1986 1986 1986 1986 1986 1986

PROPYLTHIOURACIL
TABLET; ORAL PROPYLTHIOURACIL BD ACTAVIS ELIZABETH BD + DAVA PHARMS INC BD WEST WARD

50MG 50MG 50MG

A080172 001 N006188 001 A080154 001

PROTAMINE SULFATE
INJECTABLE; INJECTION

PROTAMINE SULFATE

XX + APP PHARMS

10MG/ML

A089454 001

Apr 07, 1987

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

PROTRIPTYLINE HYDROCHLORIDE
TABLET; ORAL PROTRIPTYLINE HYDROCHLORIDE ROXANE AB 5MG AB 10MG SIGMAPHARM LABS LLC AB 5MG AB 10MG VIVACTIL ODYSSEY PHARMS AB 5MG AB + 10MG

3 - 353 (of 424)

A078913 A078913 A090462 A090462

001 002 001 002

Sep Sep May May

16, 16, 03, 03,

2008 2008 2010 2010

A073644 001 A073645 001

Aug 24, 1995 Aug 24, 1995

PYRAZINAMIDE
TABLET; ORAL PYRAZINAMIDE AB + DAVA PHARMS INC MIKART AB

500MG 500MG

A080157 001 A081319 001

Jun 30, 1992

PYRIDOSTIGMINE BROMIDE
INJECTABLE; INJECTION MESTINON AP + VALEANT PHARM INTL REGONOL SANDOZ AP SYRUP; ORAL

MESTINON

XX + VALEANT PHARM INTL TABLET; ORAL MESTINON AB + VALEANT PHARM INTL PYRIDOSTIGMINE BROMIDE COREPHARMA AB IMPAX LABS AB

5MG/ML 5MG/ML

N009830 001 N017398 001

60MG/5ML

N015193 001

60MG 60MG 60MG

N009829 002 A040457 001 A040502 001 Dec 26, 2002 Apr 24, 2003

TABLET, EXTENDED RELEASE; ORAL

MESTINON

XX + VALEANT PHARM INTL 180MG

N011665 001

PYRIDOXINE HYDROCHLORIDE
INJECTABLE; INJECTION

PYRIDOXINE HYDROCHLORIDE

100MG/ML XX + APP PHARMS

A080618 001

PYRIMETHAMINE
TABLET; ORAL

DARAPRIM

XX + COREPHARMA

25MG

N008578 001

QUAZEPAM
TABLET; ORAL

DORAL

XX + QUESTCOR PHARMS

15MG

N018708 001

Dec 27, 1985

QUETIAPINE FUMARATE
TABLET; ORAL

SEROQUEL

XX + ASTRAZENECA XX XX XX XX +

EQ EQ EQ EQ EQ

25MG BASE 50MG BASE 100MG BASE 200MG BASE 300MG BASE

N020639 N020639 N020639 N020639 N020639

001 007 002 003 005

Sep Oct Sep Sep Jul

26, 04, 26, 26, 26,

1997 2005 1997 1997 2000

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

QUETIAPINE FUMARATE
TABLET; ORAL SEROQUEL ASTRAZENECA XX

3 - 354 (of 424)

EQ 400MG BASE

N020639 006

Oct 04, 2005

TABLET, EXTENDED RELEASE; ORAL SEROQUEL XR ASTRAZENECA EQ 50MG BASE XX EQ 150MG BASE XX EQ 200MG BASE XX + EQ 300MG BASE XX EQ 400MG BASE XX

N022047 N022047 N022047 N022047 N022047

001 005 002 003 004

May Aug May May May

17, 11, 17, 17, 17,

2007 2008 2007 2007 2007

QUINAPRIL HYDROCHLORIDE
TABLET; ORAL ACCUPRIL PFIZER PHARMS AB AB AB AB + QUINAPRIL HYDROCHLORIDE APOTEX AB AB AB AB INVAGEN PHARMS AB AB AB AB LUPIN AB AB AB AB MYLAN AB AB AB AB AB AB AB AB RANBAXY AB AB AB AB SANDOZ AB AB AB AB SUN PHARM INDS LTD AB AB AB AB TEVA AB AB AB AB WATSON LABS FLORIDA AB AB AB AB

EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ

5MG BASE 10MG BASE 20MG BASE 40MG BASE 5MG BASE 10MG BASE 20MG BASE 40MG BASE 5MG BASE 10MG BASE 20MG BASE 40MG BASE 5MG BASE 10MG BASE 20MG BASE 40MG BASE 5MG BASE 5MG BASE 10MG BASE 10MG BASE 20MG BASE 20MG BASE 40MG BASE 40MG BASE 5MG BASE 10MG BASE 20MG BASE 40MG BASE 5MG BASE 10MG BASE 20MG BASE 40MG BASE 5MG BASE 10MG BASE 20MG BASE 40MG BASE 5MG BASE 10MG BASE 20MG BASE 40MG BASE 5MG BASE 10MG BASE 20MG BASE 40MG BASE

N019885 N019885 N019885 N019885 A076240 A076240 A076240 A076240 A078457 A078457 A078457 A078457 A077690 A077690 A077690 A077690 A076036 A076694 A076036 A076694 A076036 A076694 A076036 A076694 A076607 A076607 A076607 A076607 A076803 A076803 A076803 A076803 A090800 A090800 A090800 A090800 A075504 A075504 A075504 A075504 A076049 A076049 A076049 A076049

001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 001 002 002 003 003 004 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004

Nov Nov Nov Nov Jan Jan Jan Jan Aug Aug Aug Aug Jun Jun Jun Jun Jan Dec Jan Dec Jan Dec Jan Dec Dec Dec Dec Dec Mar Mar Mar Mar Jun Jun Jun Jun Aug Aug Aug Aug Jan Jan Jan Jan

19, 19, 19, 19, 26, 26, 26, 26, 24, 24, 24, 24, 20, 20, 20, 20, 28, 23, 28, 23, 28, 23, 28, 23, 15, 15, 15, 15, 02, 02, 02, 02, 18, 18, 18, 18, 24, 24, 24, 24, 14, 14, 14, 14,

1991 1991 1991 1991 2006 2006 2006 2006 2007 2007 2007 2007 2006 2006 2006 2006 2005 2004 2005 2004 2005 2004 2005 2004 2004 2004 2004 2004 2005 2005 2005 2005 2009 2009 2009 2009 2007 2007 2007 2007 2005 2005 2005 2005

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

QUINIDINE GLUCONATE
INJECTABLE; INJECTION

QUINIDINE GLUCONATE

XX + LILLY

3 - 355 (of 424)

80MG/ML

N007529 002

Feb 10, 1989

TABLET, EXTENDED RELEASE; ORAL QUINIDINE GLUCONATE BX + MUTUAL PHARM 324MG BX WATSON LABS 324MG

A089338 001 A087810 001

Feb 11, 1987 Sep 29, 1982

QUINIDINE SULFATE
TABLET; ORAL QUINIDINE SULFATE MUTUAL PHARM AB AB SANDOZ AB AB AB + WATSON LABS AB +

200MG 300MG 200MG 300MG 200MG 300MG

A081030 A081031 A088072 A088072 A083288 A085583

001 001 002 001 001 001

Apr 14, 1989 Apr 14, 1989 Sep 26, 1983

TABLET, EXTENDED RELEASE; ORAL

QUINIDINE SULFATE
300MG XX + TEVA PHARMS

A040045 001

Jun 30, 1994

QUININE SULFATE

CAPSULE; ORAL

QUALAQUIN
XX + AR HOLDING CO INC

324MG

N021799 001

Aug 12, 2005

RABEPRAZOLE SODIUM
TABLET, DELAYED RELEASE; ORAL

ACIPHEX

20MG XX + EISAI INC

N020973 002

Aug 19, 1999

RALOXIFENE HYDROCHLORIDE
TABLET; ORAL

EVISTA

XX + LILLY

60MG

N020815 001

Dec 09, 1997

RALTEGRAVIR POTASSIUM
TABLET; ORAL

ISENTRESS

XX + MERCK SHARP DOHME TABLET, CHEWABLE; ORAL ISENTRESS MERCK SHARP DOHME XX XX +

EQ 400MG BASE

N022145 001

Oct 12, 2007

EQ 25MG BASE EQ 100MG BASE

N203045 001 N203045 002

Dec 21, 2011 Dec 21, 2011

RAMELTEON

TABLET; ORAL

ROZEREM
XX + TAKEDA GLOBAL

8MG

N021782 001

Jul 22, 2005

RAMIPRIL
CAPSULE; ORAL ALTACE KING PHARMS AB AB AB AB +

1.25MG 2.5MG 5MG 10MG

N019901 N019901 N019901 N019901

001 002 003 004

Jan Jan Jan Jan

28, 28, 28, 28,

1991 1991 1991 1991

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

RAMIPRIL
CAPSULE; ORAL RAMIPRIL APOTEX AB AB AB AB AUROBINDO PHARMA LTD AB AB AB AB CIPLA AB AB AB AB DR REDDYS LABS LTD AB AB AB AB INVAGEN PHARMS AB AB AB AB LUPIN AB AB AB AB RANBAXY AB AB ROXANE AB AB AB AB SANDOZ AB AB AB AB TEVA PHARMS AB AB AB AB WATSON LABS AB AB AB AB ZYDUS PHARMS USA AB AB AB AB TABLET; ORAL ALTACE KING PHARMS AB AB AB AB + RAMIPRIL MATRIX LABS LTD AB AB AB AB

3 - 356 (of 424)

1.25MG 2.5MG 5MG 10MG 1.25MG 2.5MG 5MG 10MG 1.25MG 2.5MG 5MG 10MG 1.25MG 2.5MG 5MG 10MG 1.25MG 2.5MG 5MG 10MG 1.25MG 2.5MG 5MG 10MG 5MG 10MG 1.25MG 2.5MG 5MG 10MG 1.25MG 2.5MG 5MG 10MG 1.25MG 2.5MG 5MG 10MG 1.25MG 2.5MG 5MG 10MG 1.25MG 2.5MG 5MG 10MG

A079116 A079116 A079116 A079116 A091604 A091604 A091604 A091604 A077004 A077004 A077004 A077004 A078191 A078191 A078191 A078191 A078745 A078745 A078745 A078745 A077626 A077626 A077626 A077626 A078849 A078849 A077900 A077900 A077900 A077900 A077514 A077514 A077514 A077514 A077470 A077470 A077470 A077470 A076549 A076549 A076549 A076549 A078832 A078832 A078832 A078832

001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004

Jun Jun Jun Jun Jun Jun Jun Jun Aug Aug Aug Aug Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Mar Mar Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Oct Oct Oct Oct Sep Sep Sep Sep

20, 20, 20, 20, 08, 08, 08, 08, 07, 07, 07, 07, 18, 18, 18, 18, 18, 18, 18, 18, 09, 09, 09, 09, 06, 06, 18, 18, 18, 18, 18, 18, 18, 18, 18, 18, 18, 18, 24, 24, 24, 24, 02, 02, 02, 02,

2008 2008 2008 2008 2011 2011 2011 2011 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2009 2009 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2005 2005 2005 2005 2008 2008 2008 2008

1.25MG 2.5MG 5MG 10MG 1.25MG 2.5MG 5MG 10MG

N022021 N022021 N022021 N022021 A090650 A090650 A090650 A090650

001 002 003 004 001 002 003 004

Feb Feb Feb Feb Jun Jun Jun Jun

27, 27, 27, 27, 30, 30, 30, 30,

2007 2007 2007 2007 2011 2011 2011 2011

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

RAMIPRIL
TABLET; ORAL RAMIPRIL ZYDUS PHARMS USA INC AB AB AB AB

3 - 357 (of 424)

1.25MG 2.5MG 5MG 10MG

A090697 A090697 A090697 A090697

001 002 003 004

Sep Sep Sep Sep

24, 24, 24, 24,

2009 2009 2009 2009

RANITIDINE HYDROCHLORIDE
CAPSULE; ORAL RANITIDINE HYDROCHLORIDE DR REDDYS LABS LTD EQ EQ SANDOZ EQ + EQ

AB AB AB AB

150MG 300MG 150MG 300MG

BASE BASE BASE BASE

A075742 A075742 A074655 A074655

001 002 001 002

Nov Nov Oct Oct

29, 29, 22, 22,

2000 2000 1997 1997

AP AP AP XX

INJECTABLE; INJECTION RANITIDINE HYDROCHLORIDE BEDFORD EQ 25MG BASE/ML BEN VENUE EQ 25MG BASE/ML ZANTAC + GLAXOSMITHKLINE EQ 25MG BASE/ML ZANTAC IN PLASTIC CONTAINER + GLAXOSMITHKLINE EQ 1MG BASE/ML SYRUP; ORAL RANITIDINE HYDROCHLORIDE ACTAVIS MID ATLANTIC EQ AMNEAL PHARMS EQ APOTEX EQ AUROBINDO PHARM EQ CYPRESS PHARM EQ DR REDDYS LABS LTD EQ HI TECH PHARMA EQ PHARM ASSOC EQ RANBAXY EQ SILARX EQ SUN PHARM INDS INC EQ TARO EQ TOLMAR EQ VINTAGE PHARMS EQ WOCKHARDT EQ EQ ZANTAC + GLAXOSMITHKLINE EQ TABLET; ORAL RANITIDINE HYDROCHLORIDE AMNEAL PHARMS NY EQ EQ APOTEX EQ EQ DR REDDYS LABS INC EQ EQ GLENMARK GENERICS EQ EQ IVAX SUB TEVA PHARMS EQ EQ MYLAN EQ EQ PAR PHARM EQ EQ SANDOZ EQ

A077458 001 A074777 001 N019090 001 N019593 002

Feb 16, 2006 Mar 02, 2005 Oct 19, 1984 Sep 27, 1991

AA AA AA AA AA AA AA AA AA AA AA AA AA AA AA AA AA

15MG 15MG 15MG 15MG 15MG 15MG 15MG 15MG 15MG 15MG 15MG 15MG 15MG 15MG 15MG 15MG

BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML

A076124 A078312 A077602 A090623 A078684 A090102 A091078 A077405 A078448 A091288 A091091 A077476 A090054 A078890 A079211 A079212

001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001

Feb Sep Sep Jul Aug May Mar Sep Dec Dec Sep Jun Nov Jul May Feb

21, 02, 17, 28, 27, 26, 22, 21, 13, 09, 20, 13, 15, 01, 26, 23,

2007 2008 2007 2010 2009 2009 2011 2007 2007 2010 2011 2011 2010 2010 2009 2009

15MG BASE/ML

N019675 001

Dec 30, 1988

AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB

150MG 300MG 150MG 300MG 150MG 300MG 150MG 300MG 150MG 300MG 150MG 300MG 150MG 300MG 150MG

BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE

A077824 A077824 A074680 A074680 A076705 A076705 A078542 A078542 A075165 A075165 A074023 A074023 A075180 A075180 A074467

001 002 001 002 001 002 001 002 001 002 001 002 001 002 001

Oct Oct Sep Sep Jul Jul Nov Nov Sep Sep Aug Aug Jan Jan Aug

13, 13, 12, 12, 27, 27, 19, 19, 30, 30, 22, 22, 28, 28, 29,

2006 2006 1997 1997 2005 2005 2008 2008 1998 1998 1997 1997 1999 1999 1997

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

RANITIDINE HYDROCHLORIDE
TABLET; ORAL RANITIDINE HYDROCHLORIDE SANDOZ AB EQ 300MG TEVA AB EQ 150MG AB EQ 300MG WATSON LABS AB EQ 150MG AB EQ 150MG AB EQ 300MG AB EQ 300MG WOCKHARDT AB EQ 150MG AB EQ 150MG AB EQ 300MG AB EQ 300MG ZANTAC 150 GLAXOSMITHKLINE AB EQ 150MG ZANTAC 300 AB + GLAXOSMITHKLINE EQ 300MG

3 - 358 (of 424)

BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE

A074467 A074488 A074488 A074864 A077426 A074864 A077426 A075208 A078701 A075208 A078701

002 001 002 001 001 002 002 001 001 002 002

Aug Jul Jul Oct Dec Oct Dec Dec Nov Dec Dec

29, 31, 31, 20, 19, 20, 19, 17, 12, 17, 11,

1997 1997 1997 1997 2005 1997 2005 1998 2009 1998 2009

N018703 001 N018703 002

Jun 09, 1983 Dec 09, 1985

TABLET, EFFERVESCENT; ORAL

ZANTAC 25
EQ 25MG BASE XX + GLAXOSMITHKLINE

N020251 003

Apr 01, 2004

RANOLAZINE
TABLET, EXTENDED RELEASE; ORAL RANEXA GILEAD 500MG XX 1GM XX +

N021526 002 N021526 001

Jan 27, 2006 Feb 12, 2007

RASAGILINE MESYLATE
TABLET; ORAL AZILECT TEVA XX XX +

EQ 0.5MG BASE EQ 1MG BASE

N021641 001 N021641 002

May 16, 2006 May 16, 2006

REGADENOSON
SOLUTION; INTRAVENOUS
LEXISCAN
XX + ASTELLAS

0.4MG/5ML (0.08MG/ML)

N022161 001

Apr 10, 2008

REMIFENTANIL HYDROCHLORIDE
INJECTABLE; INJECTION
ULTIVA
MYLAN INSTITUTIONAL XX XX XX +

EQ 1MG BASE/VIAL EQ 2MG BASE/VIAL EQ 5MG BASE/VIAL

N020630 001 N020630 002 N020630 003

Jul 12, 1996 Jul 12, 1996 Jul 12, 1996

REPAGLINIDE
TABLET; ORAL PRANDIN NOVO NORDISK INC XX XX XX +

0.5MG 1MG 2MG

N020741 001 N020741 002 N020741 003

Dec 22, 1997 Dec 22, 1997 Dec 22, 1997

RESERPINE
TABLET; ORAL RESERPINE BP SANDOZ BP +

0.1MG 0.25MG

N009838 001 N009838 002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

RESERPINE
TABLET; ORAL SERPALAN BP LANNETT BP

3 - 359 (of 424)

0.1MG 0.25MG

N010124 001 N010124 002

RETAPAMULIN
OINTMENT; TOPICAL

ALTABAX

XX + GLAXO GRP LTD

1%

N022055 001

Apr 12, 2007

RIBAVIRIN
CAPSULE; ORAL REBETOL + SCHERING PLOUGH RES RIBASPHERE THREE RIVERS PHARMS RIBAVARIN AUROBINDO PHARMA RIBAVIRIN SANDOZ TEVA ZYDUS PHARMS USA REBETOL + SCHERING PLOUGH RES

AB AB AB AB AB AB XX

200MG 200MG 200MG 200MG 200MG 200MG 200MG

N020903 002 A076203 001 A079117 001 A076192 001 A076277 001 A077224 001 N020903 001

Jul 25, 2001 Apr 06, 2004 Sep 17, 2009 Apr 06, 2004 Oct 04, 2004 Oct 28, 2005 Jun 03, 1998

FOR SOLUTION; INHALATION

VIRAZOLE

XX + VALEANT PHARM INTL SOLUTION; ORAL

REBETOL

XX + SCHERING TABLET; ORAL COPEGUS ROCHE RIBAVIRIN AUROBINDO PHARMA SANDOZ TEVA THREE RIVERS PHARMS + ZYDUS PHARMS USA

6GM/VIAL

N018859 001

Dec 31, 1985

40MG/ML

N021546 001

Jul 29, 2003

AB AB AB AB AB AB AB AB AB AB XX

200MG 200MG 200MG 200MG 200MG 400MG 600MG 200MG 400MG 600MG 500MG

N021511 001 A079111 A077743 A077053 A077456 A077456 A077456 A077094 A077094 A077094 001 001 001 001 002 003 001 002 003

Dec 03, 2002 Sep Oct Dec Dec Dec Dec Dec Mar Mar 17, 03, 05, 05, 05, 05, 05, 16, 16, 2009 2006 2005 2005 2005 2005 2005 2007 2007

RIBAVIRIN ZYDUS PHARMS USA

A077094 004

Apr 18, 2008

RIFABUTIN
CAPSULE; ORAL

MYCOBUTIN

XX + PHARMACIA AND UPJOHN

150MG

N050689 001

Dec 23, 1992

RIFAMPIN
CAPSULE; ORAL RIFADIN SANOFI AVENTIS US AB AB + RIFAMPIN LANNETT AB

150MG 300MG 150MG

A062303 001 N050420 001 A065390 001 Mar 28, 2008

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

RIFAMPIN
CAPSULE; ORAL RIFAMPIN LANNETT AB SANDOZ AB AB VERSAPHARM AB AB INJECTABLE; INJECTION RIFADIN + SANOFI AVENTIS US RIFAMPIN BEDFORD PFIZER VERSAPHARM INC

3 - 360 (of 424)

300MG 150MG 300MG 150MG 300MG

A065390 A064150 A064150 A065028 A065028

002 002 001 001 002

Mar Jan May Mar Mar

28, 02, 28, 14, 14,

2008 1998 1997 2001 2001

AP AP AP AP

600MG/VIAL 600MG/VIAL 600MG/VIAL 600MG/VIAL

N050627 001 A064217 001 A065421 001 A065502 001

May 25, 1989 Oct 29, 1999 May 22, 2008 Sep 21, 2010

RIFAPENTINE
TABLET; ORAL

PRIFTIN

XX + SANOFI AVENTIS US

150MG

N021024 001

Jun 22, 1998

RIFAXIMIN

TABLET; ORAL

XIFAXAN
XX + SALIX PHARMS XX +

200MG 550MG

N021361 001 N022554 001

May 25, 2004 Mar 24, 2010

RILPIVIRINE HYDROCHLORIDE

TABLET; ORAL

EDURANT
XX + TIBOTEC

EQ 25MG BASE

N202022 001

May 20, 2011

RILUZOLE
TABLET; ORAL RILUTEK AB + SANOFI AVENTIS US RILUZOLE IMPAX LABS AB

50MG 50MG

N020599 001 A076173 001

Dec 12, 1995 Jan 29, 2003

RIMANTADINE HYDROCHLORIDE
TABLET; ORAL FLUMADINE AB + CARACO 100MG RIMANTADINE HYDROCHLORIDE COREPHARMA AB 100MG IMPAX LABS AB 100MG

N019649 001 A075916 001 A076132 001

Sep 17, 1993 Nov 02, 2001 Aug 30, 2002

RIMEXOLONE
SUSPENSION/DROPS; OPHTHALMIC
VEXOL
XX + ALCON 1%

N020474 001

Dec 30, 1994

RISEDRONATE SODIUM
TABLET; ORAL ACTONEL WARNER CHILCOTT AB AB AB +

5MG 30MG 35MG

N020835 002 N020835 001 N020835 003

Apr 14, 2000 Mar 27, 1998 May 25, 2002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

RISEDRONATE SODIUM
TABLET; ORAL RISEDRONATE SODIUM TEVA PHARMS AB AB AB ACTONEL XX + WARNER CHILCOTT

3 - 361 (of 424)

5MG 30MG 35MG 150MG

A077132 001 A077132 002 A077132 003 N020835 005

Oct 05, 2007 Oct 05, 2007 Oct 05, 2007 Apr 22, 2008

TABLET, DELAYED RELEASE; ORAL

ATELVIA

35MG XX + WARNER CHILCOTT

N022560 001

Oct 08, 2010

RISPERIDONE
INJECTABLE; INTRAMUSCULAR RISPERDAL CONSTA JANSSEN PHARMS 12.5MG/VIAL XX 25MG/VIAL XX + 37.5MG/VIAL XX 50MG/VIAL XX SOLUTION; ORAL RISPERDAL + JANSSEN PHARMS RISPERIDONE AMNEAL PHARMS APOTEX INC AUROBINDO PHARMA DR REDDYS LABS LTD PRECISION DOSE ROXANE TARO TEVA VINTAGE WOCKHARDT

N021346 N021346 N021346 N021346

004 001 002 003

Apr Oct Oct Oct

12, 29, 29, 29,

2007 2003 2003 2003

AA AA AA AA AA AA AA AA AA AA AA

1MG/ML 1MG/ML 1MG/ML 1MG/ML 1MG/ML 1MG/ML 1MG/ML 1MG/ML 1MG/ML 1MG/ML 1MG/ML

N020588 001 A091384 A077719 A078452 A078909 A076797 A076904 A090347 A076440 A079158 A078744 001 001 001 001 001 001 001 001 001 001

Jun 10, 1996 May Jul Sep Jul Jun Jul Feb Jan Dec Oct 25, 29, 04, 29, 28, 29, 07, 30, 03, 08, 2011 2009 2009 2009 2010 2009 2011 2009 2010 2009

TABLET; ORAL RISPERDAL JANSSEN PHARMS AB AB AB + AB AB AB RISPERIDONE AJANTA PHARMA LTD AB AB AB AB AB AB APOTEX INC AB AB AB AB AB AB AUROBINDO PHARMA AB AB AB AB AB AB

0.25MG 0.5MG 1MG 2MG 3MG 4MG 0.25MG 0.5MG 1MG 2MG 3MG 4MG 0.25MG 0.5MG 1MG 2MG 3MG 4MG 0.25MG 0.5MG 1MG 2MG 3MG 4MG

N020272 N020272 N020272 N020272 N020272 N020272 A201003 A201003 A201003 A201003 A201003 A201003 A077953 A077953 A077953 A077953 A077953 A077953 A078269 A078269 A078269 A078269 A078269 A078269

008 007 001 002 003 004 001 002 003 004 005 006 001 002 003 004 005 006 001 002 003 004 005 006

May Jan Dec Dec Dec Dec Aug Aug Aug Aug Aug Aug Sep Sep Sep Sep Sep Sep Oct Oct Oct Oct Oct Oct

10, 27, 29, 29, 29, 29, 24, 24, 24, 24, 24, 24, 15, 15, 15, 15, 15, 15, 08, 08, 08, 08, 08, 08,

1999 1999 1993 1993 1993 1993 2011 2011 2011 2011 2011 2011 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

RISPERIDONE
TABLET; ORAL RISPERIDONE CIPLA AB AB AB AB AB AB DR REDDYS LABS LTD AB AB AB AB AB AB MYLAN AB AB AB AB AB AB PLIVA HRVATSKA DOO AB AB AB AB AB AB PRINSTON INC AB AB AB AB AB AB SANDOZ AB AB AB AB AB AB TEVA AB AB AB AB AB AB TORRENT PHARMS AB AB AB AB AB AB VINTAGE AB AB AB AB AB AB WATSON LABS AB AB AB

3 - 362 (of 424)

0.25MG 0.5MG 1MG 2MG 3MG 4MG 0.25MG 0.5MG 1MG 2MG 3MG 4MG 0.25MG 0.5MG 1MG 2MG 3MG 4MG 0.25MG 0.5MG 1MG 2MG 3MG 4MG 0.25MG 0.5MG 1MG 2MG 3MG 4MG 0.25MG 0.5MG 1MG 2MG 3MG 4MG 0.25MG 0.5MG 1MG 2MG 3MG 4MG 0.25MG 0.5MG 1MG 2MG 3MG 4MG 0.25MG 0.5MG 1MG 2MG 3MG 4MG 0.25MG 0.5MG 1MG

A077543 A077543 A077543 A077543 A077543 A077543 A076879 A076879 A076879 A076879 A076879 A076879 A076288 A076288 A076288 A076288 A076288 A076288 A077769 A077769 A077769 A077769 A077769 A077769 A077493 A077493 A077493 A077493 A077493 A077493 A078528 A078528 A078528 A078528 A078528 A078528 A076228 A076228 A076228 A076228 A076228 A076228 A079088 A079088 A079088 A079088 A079088 A079088 A078707 A078707 A078707 A078707 A078707 A078707 A077860 A077860 A077860

001 002 003 004 005 006 001 002 003 004 005 006 001 002 003 004 005 006 001 002 003 004 005 006 001 002 003 004 005 006 001 002 003 004 005 006 001 002 003 004 005 006 001 002 003 004 005 006 001 002 003 004 005 006 001 002 003

May May May May May May Oct Oct Oct Oct Oct Oct Sep Sep Sep Sep Sep Sep Oct Oct Oct Oct Oct Oct Nov Nov Nov Nov Nov Nov Oct Oct Oct Oct Oct Oct Jun Jun Jun Jun Jun Jun Oct Oct Oct Oct Oct Oct Dec Dec Dec Dec Dec Dec Dec Dec Dec

18, 18, 18, 18, 18, 18, 24, 24, 24, 24, 24, 24, 15, 15, 15, 15, 15, 15, 16, 16, 16, 16, 16, 16, 29, 29, 29, 29, 29, 29, 16, 16, 16, 16, 16, 16, 30, 30, 30, 30, 30, 30, 30, 30, 30, 30, 30, 30, 29, 29, 29, 29, 29, 29, 05, 05, 05,

2011 2011 2011 2011 2011 2011 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2011 2011 2011 2011 2011 2011 2009 2009 2009 2009 2009 2009 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

RISPERIDONE
TABLET; ORAL RISPERIDONE WATSON LABS AB AB AB WEST WARD PHARMS AB AB AB AB AB AB WOCKHARDT AB AB AB AB AB AB ZYDUS PHARMS USA INC AB AB AB AB AB AB

3 - 363 (of 424)

2MG 3MG 4MG 0.25MG 0.5MG 1MG 2MG 3MG 4MG 0.25MG 0.5MG 1MG 2MG 3MG 4MG 0.25MG 0.5MG 1MG 2MG 3MG 4MG

A077860 A077860 A077860 A078740 A078740 A078740 A078740 A078740 A078740 A078871 A078871 A078871 A078871 A078871 A078871 A078040 A078040 A078040 A078040 A078040 A078040

004 005 006 001 002 003 004 005 006 001 002 003 004 005 006 001 002 003 004 005 006

Dec Dec Dec May May May May May May Oct Oct Oct Oct Oct Oct Oct Oct Oct Oct Oct Oct

05, 05, 05, 29, 29, 29, 29, 29, 29, 09, 09, 09, 09, 09, 09, 16, 16, 16, 16, 16, 16,

2008 2008 2008 2009 2009 2009 2009 2009 2009 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008

AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB

TABLET, ORALLY DISINTEGRATING; ORAL RISPERDAL JANSSEN PHARMS 0.5MG + 1MG 2MG 3MG 4MG RISPERIDONE DR REDDYS LABS LTD 0.5MG 1MG 2MG JUBILANT ORGANOSYS 0.5MG 1MG 2MG 3MG 4MG MYLAN 0.5MG 1MG 2MG 3MG 4MG PAR PHARM 0.5MG 1MG 2MG 3MG 4MG RANBAXY 0.5MG 1MG 2MG 3MG 4MG SANDOZ 0.5MG 1MG 2MG 3MG 4MG

N021444 N021444 N021444 N021444 N021444 A077328 A077328 A077328 A090839 A090839 A090839 A090839 A090839 A091537 A091537 A091537 A091537 A091537 A077494 A077494 A077494 A077494 A077494 A077542 A077542 A077542 A078474 A078474 A078116 A078116 A078116 A078116 A078116

001 002 003 004 005 001 002 003 001 002 003 004 005 001 002 003 004 005 002 003 004 005 006 001 002 003 001 002 001 002 003 004 005

Apr Apr Apr Dec Dec Feb Oct Feb Nov Nov Nov Nov Nov Mar Mar Mar Mar Mar Apr Oct Apr Apr Apr Aug Aug Aug Aug Aug Dec Dec Dec Dec Dec

02, 02, 02, 23, 23, 24, 05, 24, 04, 04, 04, 04, 04, 30, 30, 30, 30, 30, 30, 26, 30, 30, 30, 06, 06, 06, 06, 06, 22, 22, 22, 22, 22,

2003 2003 2003 2004 2004 2009 2009 2009 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2009 2009 2009 2009 2009 2010 2010 2010 2010 2010 2009 2009 2009 2009 2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

RISPERIDONE
TABLET, ORALLY DISINTEGRATING; ORAL RISPERIDONE WATSON LABS FLORIDA 0.5MG 1MG 2MG 3MG 4MG ZYDUS PHARMS USA 0.5MG 2MG RISPERIDONE PAR PHARM 0.25MG

3 - 364 (of 424)

AB AB AB AB AB AB AB XX

A076996 A076996 A076996 A076996 A076996 A078516 A078516

001 002 003 004 005 001 003

Apr Apr Apr Apr Apr May May

19, 19, 19, 19, 19, 01, 01,

2011 2011 2011 2011 2011 2009 2009

A077494 001

Apr 30, 2009

RITONAVIR
CAPSULE; ORAL

NORVIR

XX + ABBOTT SOLUTION; ORAL

NORVIR

XX + ABBOTT TABLET; ORAL

NORVIR

XX + ABBOTT LABS

100MG

N020945 001

Jun 29, 1999

80MG/ML

N020659 001

Mar 01, 1996

100MG

N022417 001

Feb 10, 2010

RIVAROXABAN

TABLET; ORAL

XARELTO
XX + JANSSEN PHARMS XX XX +

10MG 15MG 20MG

N022406 001 N202439 001 N202439 002

Jul 01, 2011 Nov 04, 2011 Nov 04, 2011

RIVASTIGMINE
FILM, EXTENDED RELEASE; TRANSDERMAL EXELON XX NOVARTIS 4.6MG/24HR XX + 9.5MG/24HR

N022083 001 N022083 002

Jul 06, 2007 Jul 06, 2007

RIVASTIGMINE TARTRATE
CAPSULE; ORAL EXELON AB + NOVARTIS AB AB AB RIVASTIGMINE TARTRATE DR REDDYS LABS INC AB AB AB AB SUN PHARM INDS AB AB AB AB WATSON LABS AB AB AB AB

EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ

1.5MG BASE 3MG BASE 4.5MG BASE 6MG BASE 1.5MG BASE 3MG BASE 4.5MG BASE 6MG BASE 1.5MG BASE 3MG BASE 4.5MG BASE 6MG BASE 1.5MG BASE 3MG BASE 4.5MG BASE 6MG BASE

N020823 N020823 N020823 N020823 A077130 A077130 A077130 A077130 A077131 A077131 A077131 A077131 A077129 A077129 A077129 A077129

003 004 005 006 001 002 003 004 001 002 003 004 001 002 003 004

Apr Apr Apr Apr Oct Oct Oct Oct Oct Oct Oct Oct Jan Jan Jan Jan

21, 21, 21, 21, 31, 31, 31, 31, 22, 22, 22, 22, 08, 08, 08, 08,

2000 2000 2000 2000 2007 2007 2007 2007 2007 2007 2007 2007 2008 2008 2008 2008

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

RIVASTIGMINE TARTRATE
SOLUTION; ORAL

EXELON

XX + NOVARTIS

3 - 365 (of 424)

EQ 2MG BASE/ML

N021025 001

Apr 21, 2000

RIZATRIPTAN BENZOATE
TABLET; ORAL MAXALT MERCK XX XX +

EQ 5MG BASE EQ 10MG BASE

N020864 001 N020864 002

Jun 29, 1998 Jun 29, 1998

TABLET, ORALLY DISINTEGRATING; ORAL MAXALT-MLT XX MERCK EQ 5MG BASE XX + EQ 10MG BASE

N020865 001 N020865 002

Jun 29, 1998 Jun 29, 1998

ROCURONIUM BROMIDE
INJECTABLE; INJECTION ROCURONIUM BROMIDE APP PHARMS AP AP BIONICHE PHARMA USA AP AP HOSPIRA AP AP SAGENT STRIDES AP AP SANDOZ AP AP TEVA PARENTERAL AP AP ZEMURON AP + SCHERING AP +

50MG/5ML (10MG/ML) 100MG/10ML (10MG/ML) 50MG/5ML (10MG/ML) 100MG/10ML (10MG/ML) 50MG/5ML (10MG/ML) 100MG/10ML (10MG/ML) 50MG/5ML (10MG/ML) 100MG/10ML (10MG/ML) 50MG/5ML (10MG/ML) 100MG/10ML (10MG/ML) 50MG/5ML (10MG/ML) 100MG/10ML (10MG/ML) 50MG/5ML (10MG/ML) 100MG/10ML (10MG/ML)

A078651 A078651 A079199 A079199 A078519 A078519 A091458 A091458 A079195 A079195 A078717 A078717

001 002 001 002 001 002 001 002 001 002 001 002

Dec Dec Nov Nov Nov Nov Jul Jul Dec Dec Nov Nov

29, 29, 26, 26, 26, 26, 28, 28, 05, 05, 26, 26,

2008 2008 2008 2008 2008 2008 2010 2010 2008 2008 2008 2008

N020214 001 N020214 003

Mar 17, 1994 Mar 17, 1994

ROFLUMILAST

TABLET; ORAL

DALIRESP
XX + FOREST RES INST INC

500MCG

N022522 001

Feb 28, 2011

ROMIDEPSIN
POWDER; IV (INFUSION)
ISTODAX
XX + CELGENE

10MG/VIAL

N022393 001

Nov 05, 2009

ROPINIROLE HYDROCHLORIDE
TABLET; ORAL REQUIP AB + GLAXOSMITHKLINE EQ AB EQ AB EQ AB EQ AB EQ AB EQ AB EQ ROPINIROLE HYDROCHLORIDE ALEMBIC LTD AB EQ AB EQ AB EQ AB EQ

0.25MG BASE 0.5MG BASE 1MG BASE 2MG BASE 3MG BASE 4MG BASE 5MG BASE 0.25MG BASE 0.5MG BASE 1MG BASE 2MG BASE

N020658 N020658 N020658 N020658 N020658 N020658 N020658 A090429 A090429 A090429 A090429

001 002 003 004 006 007 005 001 002 003 004

Sep Sep Sep Sep Jan Jan Sep Mar Mar Mar Mar

19, 19, 19, 19, 27, 27, 19, 24, 24, 24, 24,

1997 1997 1997 1997 1999 1999 1997 2010 2010 2010 2010

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

ROPINIROLE HYDROCHLORIDE
TABLET; ORAL ROPINIROLE HYDROCHLORIDE ALEMBIC LTD EQ EQ EQ COREPHARMA EQ EQ EQ EQ EQ EQ EQ GLENMARK GENERICS EQ EQ EQ EQ EQ EQ EQ MYLAN EQ EQ EQ EQ EQ EQ EQ PRINSTON INC EQ EQ EQ EQ EQ EQ EQ ROXANE EQ EQ EQ EQ EQ EQ EQ TEVA EQ EQ EQ EQ EQ EQ EQ WOCKHARDT EQ EQ EQ EQ EQ EQ EQ ZYDUS PHARMS USA INC EQ EQ EQ EQ EQ

3 - 366 (of 424)

AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB

3MG BASE 4MG BASE 5MG BASE 0.25MG BASE 0.5MG BASE 1MG BASE 2MG BASE 3MG BASE 4MG BASE 5MG BASE 0.25MG BASE 0.5MG BASE 1MG BASE 2MG BASE 3MG BASE 4MG BASE 5MG BASE 0.25MG BASE 0.5MG BASE 1MG BASE 2MG BASE 3MG BASE 4MG BASE 5MG BASE 0.25MG BASE 0.5MG BASE 1MG BASE 2MG BASE 3MG BASE 4MG BASE 5MG BASE 0.25MG BASE 0.5MG BASE 1MG BASE 2MG BASE 3MG BASE 4MG BASE 5MG BASE 0.25MG BASE 0.5MG BASE 1MG BASE 2MG BASE 3MG BASE 4MG BASE 5MG BASE 0.25MG BASE 0.5MG BASE 1MG BASE 2MG BASE 3MG BASE 4MG BASE 5MG BASE 0.25MG BASE 0.5MG BASE 1MG BASE 2MG BASE 3MG BASE

A090429 A090429 A090429 A078230 A078230 A078230 A078230 A078230 A078230 A078230 A090135 A090135 A090135 A090135 A090135 A090135 A090135 A078881 A078881 A078881 A078881 A078881 A078881 A078881 A078110 A078110 A078110 A078110 A078110 A078110 A078110 A077852 A077852 A077852 A077852 A077852 A077852 A077852 A077460 A077460 A077460 A077460 A077460 A077460 A077460 A079050 A079050 A079050 A079050 A079050 A079050 A079050 A090411 A090411 A090411 A090411 A090411

005 006 007 001 002 003 004 005 006 007 001 002 003 004 005 006 007 001 002 003 004 005 006 007 001 002 003 004 005 006 007 001 002 003 004 005 006 007 001 002 003 004 005 006 007 001 002 003 004 005 006 007 001 002 003 004 005

Mar Mar Mar May May May May May May May Feb Feb Feb Feb Feb Feb Feb May May May May May May May May May May May May May Jul May May May May May May May May May May May May May May May May May May May May May Jun Jun Jun Jun Jun

24, 24, 24, 20, 20, 20, 20, 20, 20, 20, 25, 25, 25, 25, 25, 25, 25, 05, 05, 05, 05, 05, 05, 19, 05, 05, 05, 05, 05, 05, 11, 05, 05, 05, 05, 05, 05, 19, 05, 05, 05, 05, 05, 05, 19, 29, 29, 29, 29, 29, 29, 29, 01, 01, 01, 01, 01,

2010 2010 2010 2008 2008 2008 2008 2008 2008 2008 2010 2010 2010 2010 2010 2010 2010 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2009 2009 2009 2009 2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

ROPINIROLE HYDROCHLORIDE
TABLET; ORAL ROPINIROLE HYDROCHLORIDE ZYDUS PHARMS USA INC EQ 4MG BASE AB AB EQ 5MG BASE
TABLET, EXTENDED RELEASE; ORAL

REQUIP XL
EQ 2MG BASE XX + SMITHKLINE BEECHAM EQ 4MG BASE XX EQ 6MG BASE XX EQ 8MG BASE XX EQ 12MG BASE XX

3 - 367 (of 424)

A090411 006 A090411 007

Jun 01, 2009

Jun 01, 2009

N022008 N022008 N022008 N022008 N022008

001 003 006 004 005

Jun Jun Apr Jun Oct

13, 13, 10, 13, 31,

2008 2008 2009 2008 2008

ROPIVACAINE HYDROCHLORIDE MONOHYDRATE

INJECTABLE; INJECTION NAROPIN APP PHARMS XX XX XX XX +

2MG/ML 5MG/ML 7.5MG/ML 10MG/ML

N020533 N020533 N020533 N020533

001 003 004 005

Sep Sep Sep Sep

24, 24, 24, 24,

1996 1996 1996 1996

ROSIGLITAZONE MALEATE
TABLET; ORAL AVANDIA SB PHARMCO XX XX XX +

EQ 2MG BASE EQ 4MG BASE EQ 8MG BASE

N021071 002 N021071 003 N021071 004

May 25, 1999 May 25, 1999 May 25, 1999

ROSUVASTATIN CALCIUM
TABLET; ORAL CRESTOR XX IPR XX XX XX +

5MG 10MG 20MG 40MG

N021366 N021366 N021366 N021366

002 003 004 005

Aug Aug Aug Aug

12, 12, 12, 12,

2003 2003 2003 2003

RUBIDIUM CHLORIDE RB-82

INJECTABLE; INJECTION CARDIOGEN-82 BRACCO XX

N/A

N019414 001

Dec 29, 1989

RUFINAMIDE
SUSPENSION; ORAL
BANZEL
XX + EISAI INC TABLET; ORAL BANZEL XX EISAI INC XX +

40MG/ML

N201367 001

Mar 03, 2011

200MG 400MG

N021911 002 N021911 003

Nov 14, 2008 Nov 14, 2008

RUXOLITINIB PHOSPHATE
TABLET; ORAL JAKAFI INCYTE CORP XX XX XX XX XX +

EQ EQ EQ EQ EQ

5MG BASE 10MG BASE 15MG BASE 20MG BASE 25MG BASE

N202192 N202192 N202192 N202192 N202192

001 002 003 004 005

Nov Nov Nov Nov Nov

16, 16, 16, 16, 16,

2011 2011 2011 2011 2011

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

SACROSIDASE

SOLUTION; ORAL

SUCRAID
XX + QOL MEDCL

3 - 368 (of 424)

8,500 IU/ML

N020772 001

Apr 09, 1998

SAFFLOWER OIL; SOYBEAN OIL

INJECTABLE; INJECTION

LIPOSYN II 10%
XX + HOSPIRA LIPOSYN II 20% XX + HOSPIRA

5%;5% (5GM/100ML) 10%;10% (10GM/100ML)

N018997 001 N018991 001

Aug 27, 1984 Aug 27, 1984

SALMETEROL XINAFOATE

POWDER; INHALATION

SEREVENT
XX + GLAXO GRP LTD

EQ 0.05MG BASE/INH

N020692 001

Sep 19, 1997

SAMARIUM SM-153 LEXIDRONAM PENTASODIUM

INJECTABLE; INJECTION

QUADRAMET

XX + EUSA PHARMA USA

50mCi/ML

N020570 001

Mar 28, 1997

SAPROPTERIN DIHYDROCHLORIDE

TABLET; ORAL

KUVAN
XX + BIOMARIN PHARM

100MG

N022181 001

Dec 13, 2007

SAQUINAVIR MESYLATE
CAPSULE; ORAL

INVIRASE

XX + HOFFMANN LA ROCHE TABLET; ORAL

INVIRASE

XX + ROCHE

EQ 200MG BASE

N020628 001

Dec 06, 1995

EQ 500MG BASE

N021785 001

Dec 17, 2004

SAXAGLIPTIN HYDROCHLORIDE
TABLET; ORAL
ONGLYZA
BRISTOL MYERS SQUIBB XX XX +

EQ 2.5MG BASE EQ 5MG BASE

N022350 001 N022350 002

Jul 31, 2009

Jul 31, 2009

SCOPOLAMINE
FILM, EXTENDED RELEASE; TRANSDERMAL
TRANSDERM SCOP
1MG/72HR XX + NOVARTIS

N017874 001

SECOBARBITAL SODIUM
CAPSULE; ORAL

SECONAL SODIUM

XX + MARATHON PHARMS XX +

50MG 100MG

A086101 001 A086101 002

Oct 03, 1983 Oct 03, 1983

SECRETIN SYNTHETIC HUMAN

FOR SOLUTION; INTRAVENOUS
CHIRHOSTIM
16MCG/VIAL XX + CHIRHOCLIN 40MCG/VIAL XX

N021256 001 N021256 002

Apr 09, 2004 Jun 21, 2007

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

SELEGILINE
FILM, EXTENDED RELEASE; TRANSDERMAL
EMSAM
6MG/24HR XX + SOMERSET 9MG/24HR XX 12MG/24HR XX

3 - 369 (of 424)

N021336 001 N021336 002 N021336 003

Feb 27, 2006 Feb 27, 2006 Feb 27, 2006

SELEGILINE HYDROCHLORIDE
CAPSULE; ORAL ELDEPRYL AB + SOMERSET 5MG SELEGILINE HYDROCHLORIDE APOTEX AB 5MG DAVA PHARMS INC AB 5MG TABLET; ORAL SELEGILINE HYDROCHLORIDE + APOTEX INC 5MG DAVA PHARMS INC 5MG MYLAN 5MG STASON 5MG

N020647 001 A075321 001 A075352 001

May 15, 1996 Dec 04, 1998 Nov 30, 1998

AB AB AB AB

A074871 A074641 A074866 A074912

001 001 001 001

Jun Aug Nov Apr

06, 02, 26, 30,

1997 1996 1997 1998

TABLET, ORALLY DISINTEGRATING; ORAL

ZELAPAR
XX + VALEANT PHARM INTL 1.25MG

N021479 001

Jun 14, 2006

SELENIUM SULFIDE
LOTION/SHAMPOO; TOPICAL SELENIUM SULFIDE PERRIGO NEW YORK AT WOCKHARDT AT SELSUN AT + CHATTEM

2.5% 2.5% 2.5%

A089996 001 A088228 001 N007936 001

Jan 10, 1991 Sep 01, 1983

SERTACONAZOLE NITRATE
CREAM; TOPICAL
ERTACZO
XX + ORTHO JANSSEN

2%

N021385 001

Dec 10, 2003

SERTRALINE HYDROCHLORIDE
CONCENTRATE; ORAL SERTRALINE HYDROCHLORIDE AUROBINDO PHARMA AA EQ 20MG BASE/ML RANBAXY AA EQ 20MG BASE/ML ZOLOFT AA + PFIZER EQ 20MG BASE/ML TABLET; ORAL SERTRALINE HYDROCHLORIDE APOTEX INC EQ EQ EQ AUROBINDO PHARMA EQ EQ EQ AUSTARPHARMA LLC EQ EQ EQ DR REDDYS LABS LTD EQ EQ EQ HIKMA PHARMS EQ

A078861 001 A078053 001 N020990 001

Oct 31, 2008 Feb 05, 2007 Dec 07, 1999

AB AB AB AB AB AB AB AB AB AB AB AB AB

25MG BASE 50MG BASE 100MG BASE 25MG BASE 50MG BASE 100MG BASE 25MG BASE 50MG BASE 100MG BASE 25MG BASE 50MG BASE 100MG BASE 25MG BASE

A076882 A076882 A076882 A077206 A077206 A077206 A078677 A078677 A078677 A076442 A076442 A076442 A077864

001 002 003 001 002 003 001 002 003 001 002 003 001

Feb Feb Feb Feb Feb Feb Mar Mar Mar Apr Apr Apr Aug

06, 06, 06, 06, 06, 06, 04, 04, 04, 30, 30, 30, 10,

2007 2007 2007 2007 2007 2007 2009 2009 2009 2007 2007 2007 2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

SERTRALINE HYDROCHLORIDE
TABLET; ORAL SERTRALINE HYDROCHLORIDE HIKMA PHARMS EQ EQ INVAGEN PHARMS EQ EQ EQ LUPIN EQ EQ EQ MATRIX LABS LTD EQ EQ EQ MYLAN EQ EQ EQ EQ EQ EQ RANBAXY EQ EQ EQ SUN PHARM INDS (IN) EQ EQ EQ TEVA EQ EQ EQ TORRENT PHARMS EQ EQ EQ WATSON LABS EQ EQ EQ WOCKHARDT EQ EQ EQ ZYDUS PHARMS USA EQ EQ EQ ZOLOFT PFIZER EQ EQ + EQ SERTRALINE HYDROCHLORIDE RANBAXY EQ EQ

3 - 370 (of 424)

AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB XX XX

50MG BASE 100MG BASE 25MG BASE 50MG BASE 100MG BASE 25MG BASE 50MG BASE 100MG BASE 25MG BASE 50MG BASE 100MG BASE 25MG BASE 25MG BASE 50MG BASE 50MG BASE 100MG BASE 100MG BASE 25MG BASE 50MG BASE 100MG BASE 25MG BASE 50MG BASE 100MG BASE 25MG BASE 50MG BASE 100MG BASE 25MG BASE 50MG BASE 100MG BASE 25MG BASE 50MG BASE 100MG BASE 25MG BASE 50MG BASE 100MG BASE 25MG BASE 50MG BASE 100MG BASE 25MG BASE 50MG BASE 100MG BASE 150MG BASE 200MG BASE

A077864 A077864 A077397 A077397 A077397 A077670 A077670 A077670 A078626 A078626 A078626 A076540 A076671 A076540 A076671 A076540 A076671 A077977 A077977 A077977 A078108 A078108 A078108 A076465 A076465 A076465 A077765 A077765 A077765 A077663 A077663 A077663 A078403 A078403 A078403 A077106 A077106 A077106

002 003 001 002 003 001 002 003 001 002 003 001 001 002 002 003 003 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003

Aug Aug Feb Feb Feb Feb Feb Feb Jan Jan Jan Mar Feb Mar Feb Mar Feb Feb Feb Feb Feb Feb Feb Aug Aug Aug Feb Feb Feb Feb Feb Feb Jan Jan Jan Feb Feb Feb

10, 10, 06, 06, 06, 06, 06, 06, 31, 31, 31, 20, 06, 20, 06, 20, 06, 06, 06, 06, 06, 06, 06, 11, 11, 11, 06, 06, 06, 06, 06, 06, 08, 08, 08, 06, 06, 06,

2009 2009 2007 2007 2007 2007 2007 2007 2008 2008 2008 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2006 2006 2006 2007 2007 2007 2007 2007 2007 2008 2008 2008 2007 2007 2007

N019839 005 N019839 001 N019839 002 A077977 004 A077977 005

Mar 06, 1996 Dec 30, 1991 Dec 30, 1991 Feb 06, 2007 Feb 06, 2007

SEVELAMER CARBONATE
FOR SUSPENSION; ORAL RENVELA GENZYME XX XX + TABLET; ORAL

RENVELA

XX + GENZYME

800MG/PACKET 2.4GM/PACKET

N022318 001 N022318 002

Aug 12, 2009 Feb 18, 2009

800MG

N022127 001

Oct 19, 2007

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

SEVELAMER HYDROCHLORIDE
TABLET; ORAL RENAGEL GENZYME XX XX +

3 - 371 (of 424)

400MG 800MG

N021179 001 N021179 002

Jul 12, 2000 Jul 12, 2000

SEVOFLURANE
LIQUID; INHALATION SEVOFLURANE BAXTER HLTHCARE HALOCARBON PRODS SOJOURN PIRAMAL CRITICAL ULTANE + ABBOTT

AN AN AN AN

100% 100% 100% 100%

A075895 001 A078650 001 A077867 001 N020478 001

Jul 02, 2002 Nov 19, 2007 May 02, 2007 Jun 07, 1995

SILDENAFIL CITRATE
SOLUTION; INTRAVENOUS

REVATIO

XX + PFIZER TABLET; ORAL

REVATIO

XX + PFIZER VIAGRA PFIZER IRELAND XX XX XX +

EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)

N022473 001

Nov 18, 2009

EQ 20MG BASE EQ 25MG BASE EQ 50MG BASE EQ 100MG BASE

N021845 001 N020895 001 N020895 002 N020895 003

Jun 03, 2005 Mar 27, 1998 Mar 27, 1998 Mar 27, 1998

SILODOSIN
CAPSULE; ORAL RAPAFLO WATSON LABS XX XX +

4MG 8MG

N022206 001 N022206 002

Oct 08, 2008 Oct 08, 2008

SILVER SULFADIAZINE
CREAM; TOPICAL SILVADENE + KING PHARMS SSD DR REDDYS LA THERMAZENE COVIDIEN SSD AF DR REDDYS LA

AB AB AB BX

1% 1% 1% 1%

N017381 001 N018578 001 N018810 001 N018578 003 Feb 25, 1982 Dec 23, 1985 Jul 11, 1990

SIMVASTATIN
TABLET; ORAL SIMVASTATIN ACCORD HLTHCARE AB AB AB AB AUROBINDO PHARMA AB AB AB AB AB BLU CARIBE AB AB

10MG 20MG 40MG 80MG 5MG 10MG 20MG 40MG 80MG 5MG 10MG

A078155 A078155 A078155 A078155 A077691 A077691 A077691 A077691 A077691 A078034 A078034

002 003 004 001 001 002 003 004 005 001 002

Feb Feb Feb Feb Dec Dec Dec Dec Dec Dec Dec

26, 26, 26, 26, 20, 20, 20, 20, 20, 20, 20,

2008 2008 2008 2008 2006 2006 2006 2006 2006 2006 2006

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

SIMVASTATIN
TABLET; ORAL SIMVASTATIN BLU CARIBE AB AB AB DR REDDYS LABS INC AB AB AB AB AB IVAX SUB TEVA PHARMS AB AB AB AB AB LUPIN AB AB AB AB AB MATRIX LABS LTD AB AB AB AB AB MICRO LABS LTD AB AB AB AB AB RANBAXY AB AB AB AB AB WATSON LABS AB AB AB AB AB ZYDUS PHARMS USA AB AB AB AB AB ZOCOR MERCK AB AB AB AB AB +

3 - 372 (of 424)

20MG 40MG 80MG 5MG 10MG 20MG 40MG 80MG 5MG 10MG 20MG 40MG 80MG 5MG 10MG 20MG 40MG 80MG 5MG 10MG 20MG 40MG 80MG 5MG 10MG 20MG 40MG 80MG 5MG 10MG 20MG 40MG 80MG 5MG 10MG 20MG 40MG 80MG 5MG 10MG 20MG 40MG 80MG 5MG 10MG 20MG 40MG 80MG

A078034 A078034 A078034 A077752 A077752 A077752 A077752 A077752 A076052 A076052 A076052 A076052 A076052 A078103 A078103 A078103 A078103 A078103 A090868 A090868 A090868 A090868 A090868 A090383 A090383 A090383 A090383 A090383 A076285 A076285 A076285 A076285 A076285 A076685 A076685 A076685 A076685 A076685 A077837 A077837 A077837 A077837 A077837 N019766 N019766 N019766 N019766 N019766

003 004 005 005 001 002 003 004 001 002 003 004 005 005 001 002 003 004 001 002 003 004 005 001 002 003 004 005 001 002 003 004 005 001 002 003 004 005 001 002 003 004 005 001 002 003 004 005

Dec Dec Dec Jan Dec Dec Dec Dec Jun Jun Jun Jun Dec Apr May May May May Jun Jun Jun Jun Jun Sep Sep Sep Sep Sep Dec Dec Dec Dec Jun Dec Dec Dec Dec Dec Dec Dec Dec Dec Dec Dec Dec Dec Dec Jul

20, 20, 20, 23, 20, 20, 20, 20, 23, 23, 23, 23, 20, 14, 11, 11, 11, 11, 08, 08, 08, 08, 08, 16, 16, 16, 16, 16, 20, 20, 20, 20, 23, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20, 23, 23, 23, 23, 10,

2006 2006 2006 2008 2006 2006 2006 2006 2006 2006 2006 2006 2006 2009 2007 2007 2007 2007 2010 2010 2010 2010 2010 2011 2011 2011 2011 2011 2006 2006 2006 2006 2006 2006 2006 2006 2006 2006 2006 2006 2006 2006 2006 1991 1991 1991 1991 1998

SIMVASTATIN; SITAGLIPTIN PHOSPHATE

TABLET; ORAL JUVISYNC MERCK SHARP DOHME XX XX XX +

10MG;EQ 100MG BASE 20MG;EQ 100MG BASE 40MG;EQ 100MG BASE

N202343 001 N202343 002 N202343 003

Oct 07, 2011 Oct 07, 2011 Oct 07, 2011

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

SINCALIDE
INJECTABLE; INJECTION

KINEVAC

XX + BRACCO

3 - 373 (of 424)

0.005MG/VIAL

N017697 001

SINECATECHINS
OINTMENT; TOPICAL

VEREGEN

XX + MEDIGENE AG

15%

N021902 001

Oct 31, 2006

SIROLIMUS
SOLUTION; ORAL

RAPAMUNE

XX + WYETH PHARMS INC TABLET; ORAL RAPAMUNE WYETH PHARMS INC XX XX XX +

1MG/ML

N021083 001

Sep 15, 1999

0.5MG 1MG 2MG

N021110 004 N021110 001 N021110 002

Jan 25, 2010 Aug 25, 2000 Aug 22, 2002

SITAGLIPTIN PHOSPHATE
TABLET; ORAL JANUVIA MERCK CO INC XX XX XX +

EQ 25MG BASE EQ 50MG BASE EQ 100MG BASE

N021995 001 N021995 002 N021995 003

Oct 16, 2006 Oct 16, 2006 Oct 16, 2006

SODIUM ACETATE ANHYDROUS

INJECTABLE; INJECTION

SODIUM ACETATE IN PLASTIC CONTAINER

2MEQ/ML XX + HOSPIRA

N018893 001

May 04, 1983

SODIUM BENZOATE; SODIUM PHENYLACETATE

SOLUTION; IV (INFUSION)
AMMONUL
XX + UCYCLYD

10%;10% (5GM/50ML;5GM/50ML)

N020645 001

Feb 17, 2005

SODIUM BICARBONATE
INJECTABLE; INJECTION

SODIUM BICARBONATE

XX + HOSPIRA XX +

0.9MEQ/ML 1MEQ/ML

A077394 001 A077394 002

Nov 09, 2005 Nov 09, 2005

SODIUM CHLORIDE
INJECTABLE; INJECTION BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER APP PHARMS 9MG/ML + HOSPIRA 9MG/ML SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER B BRAUN 450MG/100ML BAXTER HLTHCARE 450MG/100ML HOSPIRA 450MG/100ML 450MG/100ML SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 9MG/ML + APP PHARMS 900MG/100ML + B BRAUN 900MG/100ML + 9MG/ML + BAXTER HLTHCARE 9MG/ML

AP AP AP AP AP AP AP AP AP AP AP

A088911 001 N018800 001 N019635 N018016 N018090 N019759 A088912 N017464 N019635 N016677 N020178 001 001 001 001 001 001 002 004 002

Feb 07, 1985 Oct 29, 1982 Mar 09, 1988

Jun 08, 1988 Jan 10, 1985 Mar 09, 1988 Oct 30, 1985 Dec 07, 1992

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

SODIUM CHLORIDE
INJECTABLE; INJECTION SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER + BAXTER HLTHCARE 900MG/100ML + 900MG/100ML FRESENIUS MEDCL 900MG/100ML HAEMONETICS 900MG/100ML + HOSPIRA 9MG/ML + 9MG/ML 9MG/ML + 900MG/100ML + 900MG/100ML + 900MG/100ML + TARO PHARMS IRELAND 9MG/ML SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER + MALLINCKRODT 45MG/50ML (9MG/ML) 112.5MG/125ML (9MG/ML) SODIUM CHLORIDE 3% IN PLASTIC CONTAINER BAXTER HLTHCARE 3GM/100ML SODIUM CHLORIDE 5% IN PLASTIC CONTAINER BAXTER HLTHCARE 5GM/100ML SODIUM CHLORIDE IN PLASTIC CONTAINER HOSPIRA 2.5MEQ/ML

3 - 374 (of 424)

AP AP AP AP AP AP AP AP AP AP AP XX XX XX XX XX

N016677 N020178 A078177 A076316 N018803 N019217 N019465 N016366 N019465 N019480 A077407

001 001 001 001 001 001 002 001 001 001 001

Dec Apr Oct Oct Jul Jul

07, 12, 27, 29, 13, 15,

1992 2007 2004 1982 1984 1985

Jul 15, 1985 Sep 17, 1985 Aug 11, 2006 Jul 27, 2006 Jul 27, 2006 Nov 01, 1983 Nov 01, 1983 Jul 20, 1984

N021569 001 N021569 002 N019022 001 N019022 002 N018897 001

SOLUTION FOR SLUSH; IRRIGATION SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER BAXTER HLTHCARE 900MG/100ML XX SOLUTION; IRRIGATION SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER BAXTER HLTHCARE 450MG/100ML SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER B BRAUN 900MG/100ML BAXTER HLTHCARE 900MG/100ML 900MG/100ML HOSPIRA 900MG/100ML 900MG/100ML

N019319 002

May 17, 1985

AT AT AT AT AT AT

N017864 001 N016733 N017427 N017867 N017514 N018314 001 001 001 001 001

SODIUM CHROMATE CR-51

INJECTABLE; INJECTION
CHROMITOPE SODIUM
XX BRACCO

200uCi/ML

N013993 001

SODIUM FERRIC GLUCONATE COMPLEX

INJECTABLE; INJECTION FERRLECIT AB + SANOFI AVENTIS US 62.5MG/5ML SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE GENERAMEDIX AB 62.5MG/5ML

N020955 001 A078215 001

Feb 18, 1999 Mar 31, 2011

SODIUM IODIDE I-123

CAPSULE; ORAL SODIUM IODIDE I 123 AA + GE HEALTHCARE MALLINCKRODT AA AA AA + SYNCOR PHARMS AA + SOLUTION; ORAL
SODIUM IODIDE I 123
XX + GE HEALTHCARE

100uCi 100uCi 200uCi 100uCi 200uCi

N017630 A071909 A071910 N018671 N018671

001 001 001 001 002

Feb Feb May May

28, 28, 27, 27,

1989 1989 1982 1982

2mCi/ML

N017630 002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

SODIUM IODIDE I-131
CAPSULE; ORAL

SODIUM IODIDE I 131

XX + MALLINCKRODT SODIUM IODIDE I-131

DRAXIMAGE XX XX SOLUTION; ORAL

HICON

+ DRAXIMAGE + + SODIUM IODIDE I 131 + MALLINCKRODT

3 - 375 (of 424)

0.8-100mCi 9-100mCi 2-200mCi

N016517 001

N021305 006 N021305 004 May 19, 2005 Nov 18, 2004

XX XX XX XX

1-1000mCi/ML 1-500mCi/0.5ML 1-250mCi/0.25ML 3.5-150mCi/VIAL

N021305 005 N021305 003 N021305 002 N016515 001

Apr 04, 2006 Jan 24, 2003 Jan 24, 2003

SODIUM LACTATE
INJECTABLE; INJECTION SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER BAXTER HLTHCARE AP 1.87GM/100ML SODIUM LACTATE 1/6 MOLAR IN PLASTIC CONTAINER B BRAUN AP 1.87GM/100ML SODIUM LACTATE IN PLASTIC CONTAINER 5MEQ/ML XX + HOSPIRA

N016692 001 N020004 001 N018947 001 Apr 21, 1992 Sep 05, 1984

SODIUM NITRITE; SODIUM THIOSULFATE

SOLUTION, SOLUTION; INTRAVENOUS, INTRAVENOUS
NITHIODOTE
300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML XX + HOPE PHARMS (250MG/ML)

N201444 001

Jan 14, 2011

SODIUM NITROPRUSSIDE
INJECTABLE; INJECTION
NITROPRESS
XX + HOSPIRA

25MG/ML

A071961 001

Aug 01, 1988

SODIUM OXYBATE
SOLUTION; ORAL
XYREM
XX + JAZZ

500MG/ML

N021196 001

Jul 17, 2002

SODIUM PHENYLBUTYRATE
POWDER; ORAL
BUPHENYL
XX + MEDICIS TABLET; ORAL BUPHENYL AB + MEDICIS SODIUM PHENYLBUTYRATE AMPOLGEN AB

3GM/TEASPOONFUL

N020573 001

Apr 30, 1996

500MG 500MG

N020572 001 A090910 001

May 13, 1996 Nov 18, 2011

SODIUM PHOSPHATE, DIBASIC ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE

TABLET; ORAL

VISICOL
XX + SALIX PHARMS

0.398GM;1.102GM

N021097 001

Sep 21, 2000

SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE

TABLET; ORAL MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE NOVEL LABS INC AB 0.398GM;1.102GM

A079247 001

Dec 30, 2011

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 376 (of 424)

SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE

TABLET; ORAL OSMOPREP AB + SALIX PHARMS

0.398GM;1.102GM

N021892 001

Mar 16, 2006

SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC ANHYDROUS

INJECTABLE; INJECTION SODIUM PHOSPHATES IN PLASTIC CONTAINER HOSPIRA 142MG/ML;276MG/ML XX

N018892 001

May 10, 1983

SODIUM POLYSTYRENE SULFONATE

POWDER; ORAL, RECTAL KALEXATE KVK TECH 454GM/BOT KAYEXALATE + SANOFI AVENTIS US 453.6GM/BOT KIONEX PADDOCK LLC 454GM/BOT SODIUM POLYSTYRENE SULFONATE CAROLINA MEDCL 454GM/BOT CEDAR PHARMS 453.6GM/BOT CITRUSPHRMA 454GM/BOT SUSPENSION; ORAL, RECTAL KIONEX PADDOCK LLC 15GM/60ML SODIUM POLYSTYRENE SULFONATE PADDOCK LLC 15GM/60ML ROXANE 15GM/60ML SPS + CAROLINA MEDCL 15GM/60ML

AA AA AA AA AA AA

A040905 001 N011287 001 A040029 001 A089910 001 A090313 001 A040909 001

Mar 30, 2009

Feb 06, 1998 Jan 19, 1989 Dec 21, 2011 Dec 03, 2008

AA AA AA AA

A040028 001 A090590 001 A089049 001 A087859 001

Sep 17, 2007 May 13, 2011 Nov 17, 1986 Dec 08, 1982

SODIUM TETRADECYL SULFATE

INJECTABLE; INJECTION SOTRADECOL BIONICHE PHARMA XX XX +

20MG/2ML (10MG/ML) 60MG/2ML (30MG/ML)

A040541 001 A040541 002

Nov 12, 2004 Nov 12, 2004

SOLIFENACIN SUCCINATE
TABLET; ORAL VESICARE ASTELLAS XX XX +

5MG 10MG

N021518 001 N021518 002

Nov 19, 2004 Nov 19, 2004

SOMATROPIN RECOMBINANT
INJECTABLE; INJECTION GENOTROPIN BX + PHARMACIA AND UPJOHN GENOTROPIN PRESERVATIVE BX PHARMACIA AND UPJOHN HUMATROPE BX + LILLY BX NORDITROPIN BX NOVO NORDISK INC BX NORDITROPIN FLEXPRO BX NOVO NORDISK INC BX NORDITROPIN NORDIFLEX BX NOVO NORDISK INC

5.8MG/VIAL FREE 1.5MG/VIAL 5MG/VIAL 6MG/VIAL 5MG/1.5ML 10MG/1.5ML 5MG/1.5ML 10MG/1.5ML 5MG/1.5ML

N020280 006 N020280 004 N019640 004 N019640 005 N021148 001 N021148 002 N021148 008 N021148 009 N021148 004

Aug 24, 1995 Aug 24, 1995 Mar 08, 1987 Feb 04, 1999 Jun 20, 2000 Jun 20, 2000 Mar 01, 2010 Mar 01, 2010 Oct 01, 2004

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

SOMATROPIN RECOMBINANT
INJECTABLE; INJECTION NORDITROPIN NORDIFLEX BX NOVO NORDISK INC NUTROPIN BX GENENTECH OMNITROPE BX SANDOZ BX BX BX SAIZEN BX EMD SERONO SEROSTIM BX EMD SERONO BX BX TEV-TROPIN BX + FERRING VALTROPIN BX LG LIFE GENOTROPIN XX + PHARMACIA AND UPJOHN GENOTROPIN PRESERVATIVE PHARMACIA AND UPJOHN XX XX XX XX XX XX XX XX XX XX + HUMATROPE XX + LILLY XX + NORDITROPIN XX + NOVO NORDISK INC NORDITROPIN FLEXPRO NOVO NORDISK INC XX NORDITROPIN NORDIFLEX NOVO NORDISK INC XX XX NUTROPIN XX + GENENTECH NUTROPIN AQ XX + GENENTECH XX + XX + NUTROPIN AQ PEN XX + GENENTECH SAIZEN XX + EMD SERONO ZORBTIVE XX + EMD SERONO

3 - 377 (of 424)

10MG/1.5ML 5MG/VIAL 1.5MG/VIAL 5MG/1.5ML 5.8MG/VIAL 10MG/1.5ML 5MG/VIAL 4MG/VIAL 5MG/VIAL 6MG/VIAL 5MG/VIAL 5MG/VIAL 13.8MG/VIAL FREE 0.2MG/VIAL 0.4MG/VIAL 0.6MG/VIAL 0.8MG/VIAL 1MG/VIAL 1.2MG/VIAL 1.4MG/VIAL 1.6MG/VIAL 1.8MG/VIAL 2MG/VIAL 12MG/VIAL 24MG/VIAL 15MG/1.5ML 15MG/1.5ML 15MG/1.5ML 30MG/3ML 10MG/VIAL 5MG/2ML (2.5MG/ML) 10MG/2ML (5MG/ML) 20MG/2ML (10MG/ML) 10MG/2ML (5MG/ML) 8.8MG/VIAL 8.8MG/VIAL

N021148 005 N020168 001 N021426 N021426 N021426 N021426 002 003 001 004

Oct 01, 2004 Nov 17, 1993 May Jan May Aug 30, 16, 30, 25, 2006 2008 2006 2008

N019764 002 N020604 003 N020604 002 N020604 001 N019774 002 N021905 001 N020280 007 N020280 N020280 N020280 N020280 N020280 N020280 N020280 N020280 N020280 N020280 001 002 003 005 008 009 010 011 012 013

Oct 08, 1996 Jul 25, 1997 Aug 23, 1996 Aug 23, 1996 Jan 04, 2002 Apr 19, 2007 Oct 23, 1996 Jan Jan Jan Jan Jan Jan Jan Jan Jan Jan 27, 27, 27, 27, 27, 27, 27, 27, 27, 27, 1998 1998 1998 1998 1998 1998 1998 1998 1998 1998

N019640 006 N019640 007 N021148 003 N021148 010 N021148 006 N021148 007 N020168 002 N020522 003 N020522 001 N020522 004 N020522 002 N019764 003 N021597 004

Feb 04, 1999 Feb 04, 1999 Jun 20, 2000 Mar 01, 2010 Oct 01, 2004 Mar 10, 2009 Nov 17, 1993 Jan 03, 2008 Dec 29, 1995 Jan 03, 2008 Apr 22, 2002 Aug 29, 2000 Dec 01, 2003

SORAFENIB TOSYLATE

TABLET; ORAL

NEXAVAR
XX + BAYER HLTHCARE

EQ 200MG BASE

N021923 001

Dec 20, 2005

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

SORBITOL
SOLUTION; IRRIGATION

SORBITOL 3% IN PLASTIC CONTAINER

BAXTER HLTHCARE 3GM/100ML XX SORBITOL 3.3% IN PLASTIC CONTAINER

B BRAUN 3.3GM/100ML XX

3 - 378 (of 424)

N017863 001

N016741 001

SOTALOL HYDROCHLORIDE

SOLUTION; INTRAVENOUS

SOTALOL HYDROCHLORIDE
XX + ACADEMIC PHARMS TABLET; ORAL BETAPACE BAYER HLTHCARE AB1 AB1 AB1 + AB1 SORINE UPSHER SMITH AB1 AB1 AB1 AB1 SOTALOL HYDROCHLORIDE APOTEX INC AB1 AB1 AB1 AB1 IMPAX PHARMS AB1 AB1 AB1 AB1 MYLAN AB1 AB1 AB1 AB1 AB1 AB1 AB1 AB1 SANDOZ AB1 AB1 AB1 AB1 TEVA AB1 AB1 AB1 AB1 VINTAGE PHARMS AB1 AB1 AB1 AB1 BETAPACE AF BAYER HLTHCARE AB2 AB2 AB2 + SOTALOL HYDROCHLORIDE AMNEAL PHARM AB2 AB2 AB2 APOTEX AB2

150MG/10ML (15MG/ML)

N022306 001

Jul 02, 2009

80MG 120MG 160MG 240MG 80MG 120MG 160MG 240MG 80MG 120MG 160MG 240MG 80MG 120MG 160MG 240MG 80MG 80MG 120MG 120MG 160MG 160MG 240MG 240MG 80MG 120MG 160MG 240MG 80MG 120MG 160MG 240MG 80MG 120MG 160MG 240MG 80MG 120MG 160MG 80MG 120MG 160MG 80MG

N019865 N019865 N019865 N019865 A075500 A075500 A075500 A075500 A076140 A076140 A076140 A076140 A075663 A075663 A075663 A075663 A075237 A075725 A075237 A075725 A075237 A075725 A075237 A075725 A075366 A075366 A075366 A075366 A075429 A075429 A075429 A075429 A075563 A075563 A075563 A075563

001 005 002 003 001 004 002 003 001 002 003 004 001 002 003 004 001 001 002 002 003 003 004 004 001 002 003 004 001 002 003 004 001 002 003 004

Oct Apr Oct Oct Apr Apr Apr Apr Sep Sep Sep Sep Nov Nov Nov Nov May Dec May Dec May Dec May Dec May May May May May May May May Nov Nov Nov Nov

30, 20, 30, 30, 27, 27, 27, 27, 26, 26, 26, 26, 07, 07, 07, 07, 01, 19, 01, 19, 01, 19, 01, 19, 01, 01, 01, 01, 01, 01, 01, 01, 07, 07, 07, 07,

1992 1994 1992 1992 2001 2001 2001 2001 2002 2002 2002 2002 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2003 2003 2003 2003

N021151 001 N021151 002 N021151 003 A077070 A077070 A077070 A076214 001 002 003 001

Feb 22, 2000 Feb 22, 2000 Feb 22, 2000 Nov Nov Nov Aug 04, 04, 04, 27, 2005 2005 2005 2003

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

SOTALOL HYDROCHLORIDE
TABLET; ORAL SOTALOL HYDROCHLORIDE APOTEX AB2 AB2 MYLAN AB2 AB2 AB2 TEVA AB2 AB2 AB2

3 - 379 (of 424)

120MG 160MG 80MG 120MG 160MG 80MG 120MG 160MG

A076214 A076214 A077616 A077616 A077616 A076883 A076883 A076883

002 003 001 002 003 001 002 003

Aug Aug Feb Feb Feb Jul Jul Jul

27, 27, 07, 07, 07, 26, 26, 26,

2003 2003 2007 2007 2007 2004 2004 2004

SOYBEAN OIL
INJECTABLE; INJECTION INTRALIPID 10% + FRESENIUS INTRALIPID 20% + FRESENIUS + INTRALIPID 30% + FRESENIUS LIPOSYN III 10% + HOSPIRA LIPOSYN III 20% + HOSPIRA LIPOSYN III 30% + HOSPIRA NUTRILIPID 10% + B BRAUN NUTRILIPID 20% + B BRAUN

AP AP AP AP AP AP AP AP AP

10% 20% 20% 30% 10% 20% 30% 10% 20%

N017643 001 N018449 001 N020248 001 N019942 001 N018969 001 N018970 001 N020181 001 N019531 001 N019531 002

Aug 07, 1996 Dec 30, 1993 Sep 24, 1984 Sep 25, 1984 Jan 13, 1998 May 28, 1993 May 28, 1993

SPINOSAD
SUSPENSION; TOPICAL
NATROBA
XX + PARAPRO PHARMS

0.9%

N022408 001

Jan 18, 2011

SPIRONOLACTONE
TABLET; ORAL ALDACTONE GD SEARLE LLC AB AB AB + SPIRONOLACTONE ACTAVIS ELIZABETH AB AB AB AMNEAL PHARMS AB AB AB MUTUAL PHARM AB AB AB MYLAN AB AB AB SANDOZ AB VINTAGE AB AB AB

25MG 50MG 100MG 25MG 50MG 100MG 25MG 50MG 100MG 25MG 50MG 100MG 25MG 50MG 100MG 25MG 25MG 50MG 100MG

N012151 009 N012151 008 N012151 010 A040353 A040353 A040353 A091426 A091426 A091426 A089424 A089424 A089424 A040424 A040424 A040424 A086809 A040750 A040750 A040750 003 001 002 001 002 003 001 002 003 001 002 003 001 001 002 003

Dec 30, 1983 Dec 30, 1982 Dec 30, 1983 Mar Jul Jul Jun Jun Jun Jul Aug Aug Aug Aug Aug 15, 29, 29, 08, 08, 08, 23, 11, 11, 20, 20, 20, 2006 1999 1999 2010 2010 2010 1986 1999 1999 2001 2001 2001

Aug 29, 2006 Aug 29, 2006 Aug 29, 2006

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

STAVUDINE
CAPSULE; ORAL STAVUDINE AUROBINDO PHARMA AB AB AB AB HETERO DRUGS AB AB AB AB MATRIX LABS LTD AB AB MYLAN AB AB AB AB ZERIT BRISTOL MYERS SQUIBB AB AB AB AB + FOR SOLUTION; ORAL STAVUDINE AUROBINDO PHARMA AA CIPLA LTD AA ZERIT AA + BRISTOL MYERS SQUIBB

3 - 380 (of 424)

15MG 20MG 30MG 40MG 15MG 20MG 30MG 40MG 30MG 40MG 15MG 20MG 30MG 40MG 15MG 20MG 30MG 40MG

A077672 A077672 A077672 A077672 A078957 A078957 A078957 A078957 A078775 A078775 A079069 A079069 A079069 A079069 N020412 N020412 N020412 N020412

003 004 001 002 001 002 003 004 001 002 001 002 003 004 002 003 004 005

Dec Dec Dec Dec Dec Dec Dec Dec Jan Jan Dec Dec Dec Dec Jun Jun Jun Jun

29, 29, 29, 29, 29, 29, 29, 29, 05, 05, 29, 29, 29, 29, 24, 24, 24, 24,

2008 2008 2008 2008 2008 2008 2008 2008 2009 2009 2008 2008 2008 2008 1994 1994 1994 1994

1MG/ML 1MG/ML 1MG/ML

A077774 001 A078030 001 N020413 001

Dec 29, 2008 Mar 20, 2009 Sep 06, 1996

STERILE WATER FOR INJECTION

LIQUID; N/A BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER + HOSPIRA 100% STERILE WATER FOR INJECTION IN PLASTIC CONTAINER APP PHARMS 100% + B BRAUN 100% + BAXTER HLTHCARE 100% + 100% + HOSPIRA 100% + 100% + 100% TARO PHARMS IRELAND 100%

AP AP AP AP AP AP AP AP AP

N018802 001 A088400 N019633 N018632 N018632 N018233 N018801 N019869 A077393 001 001 002 001 001 001 001 001

Oct 27, 1982 Jan Feb Apr Jun 16, 29, 19, 30, 1984 1988 1988 1982

Oct 27, 1982 Dec 26, 1989 Aug 11, 2006

STERILE WATER FOR IRRIGATION

LIQUID; IRRIGATION STERILE WATER BAXTER HLTHCARE 100% STERILE WATER IN PLASTIC CONTAINER B BRAUN 100% BAXTER HLTHCARE 100% HOSPIRA 100% 100%

AT AT AT AT AT

N017428 001 N016734 N017866 N017513 N018313 001 001 001 001

STREPTOMYCIN SULFATE
INJECTABLE; INJECTION

STREPTOMYCIN SULFATE

XX + X GEN PHARMS

EQ 1GM BASE/VIAL

A064210 001

Jun 30, 1998

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

STREPTOZOCIN
INJECTABLE; INJECTION

ZANOSAR

XX + TEVA PARENTERAL

3 - 381 (of 424)

1GM/VIAL

N050577 001

May 07, 1982

STRONTIUM CHLORIDE SR-89

INJECTABLE; INJECTION METASTRON AP + GE HEALTHCARE 1mCi/ML STRONTIUM CHLORIDE SR-89 BIO NUCLEONICS AP 1mCi/ML

N020134 001 A075941 001

Jun 18, 1993 Jan 06, 2003

SUCCIMER
CAPSULE; ORAL

CHEMET

XX + LUNDBECK INC

100MG

N019998 002

Jan 30, 1991

SUCCINYLCHOLINE CHLORIDE
INJECTABLE; INJECTION ANECTINE + SANDOZ 20MG/ML QUELICIN + HOSPIRA 20MG/ML QUELICIN PRESERVATIVE FREE + HOSPIRA 20MG/ML QUELICIN PRESERVATIVE FREE + HOSPIRA 100MG/ML

AP AP AP XX

N008453 002 N008845 006 N008845 001 N008845 004

SUCRALFATE

SUSPENSION; ORAL

CARAFATE
XX + APTALIS PHARMA US TABLET; ORAL CARAFATE AB + APTALIS PHARMA US SUCRALFATE NOSTRUM LABS AB TEVA AB

1GM/10ML

N019183 001

Dec 16, 1993

1GM 1GM 1GM

N018333 001 A074415 001 A070848 001 Jun 08, 1998 Mar 29, 1996

SUFENTANIL CITRATE
INJECTABLE; INJECTION SUFENTA PRESERVATIVE FREE AP + AKORN EQ 0.05MG BASE/ML SUFENTANIL CITRATE BAXTER HLTHCARE AP EQ 0.05MG BASE/ML HOSPIRA AP EQ 0.05MG BASE/ML

N019050 001 A074413 001 A074534 001

May 04, 1984 Dec 15, 1995 Dec 11, 1996

SULCONAZOLE NITRATE

CREAM; TOPICAL

EXELDERM
XX + RANBAXY
SOLUTION; TOPICAL

EXELDERM
XX + RANBAXY

1%

N018737 001

Feb 28, 1989

1%

N018738 001

Aug 30, 1985

SULFACETAMIDE SODIUM
LOTION; TOPICAL KLARON AB + SANOFI AVENTIS US

10%

N019931 001

Dec 23, 1996

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

SULFACETAMIDE SODIUM
LOTION; TOPICAL SULFACETAMIDE SODIUM ALTANA AB PERRIGO CO TENNESSEE AB TARO AB OINTMENT; OPHTHALMIC CETAMIDE AT + ALCON SULFACETAMIDE SODIUM FERA PHARMS AT

3 - 382 (of 424)

10% 10% 10%

A077015 001 A078649 001 A078668 001

Nov 17, 2006 Mar 23, 2009 May 20, 2009

10% 10%

A080021 001 A080029 001

SOLUTION/DROPS; OPHTHALMIC BLEPH-10 AT + ALLERGAN 10% SULFACETAMIDE SODIUM ALCON UNIVERSAL AT 10% BAUSCH AND LOMB AT 10%

A080028 001 A089560 001 A040066 001 Oct 18, 1988 Dec 28, 1994

SULFADIAZINE
TABLET; ORAL
SULFADIAZINE
XX + SANDOZ

500MG

A040091 001

Jul 29, 1994

SULFAMETHOXAZOLE; TRIMETHOPRIM
INJECTABLE; INJECTION
SULFAMETHOXAZOLE AND TRIMETHOPRIM
80MG/ML;16MG/ML XX + TEVA PARENTERAL SUSPENSION; ORAL SULFAMETHOXAZOLE AND TRIMETHOPRIM AUROBINDO PHARMA 200MG/5ML;40MG/5ML + HI TECH PHARMA 200MG/5ML;40MG/5ML VINTAGE 200MG/5ML;40MG/5ML SULFATRIM PEDIATRIC ACTAVIS MID ATLANTIC 200MG/5ML;40MG/5ML TABLET; ORAL BACTRIM MUTUAL PHARM 400MG;80MG BACTRIM DS + MUTUAL PHARM 800MG;160MG SEPTRA MONARCH PHARMS 400MG;80MG SEPTRA DS MONARCH PHARMS 800MG;160MG SULFAMETHOPRIM NOVEL LABS INC 400MG;80MG SULFAMETHOPRIM-DS NOVEL LABS INC 800MG;160MG SULFAMETHOXAZOLE AND TRIMETHOPRIM AMNEAL PHARMS NY 400MG;80MG 800MG;160MG AUROBINDO PHARMA 400MG;80MG 800MG;160MG GLENMARK GENERICS 400MG;80MG 800MG;160MG MUTUAL PHARM 800MG;160MG VINTAGE 400MG;80MG 800MG;160MG VISTA PHARMS 400MG;80MG 800MG;160MG

A073303 001

Oct 31, 1991

AB AB AB AB

A091348 001 A074650 001 A077785 001 N018615 001

Jun 08, 2010 Dec 29, 1997 Jan 24, 2007 Jan 07, 1983

AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB

N017377 001 N017377 002 N017376 001 N017376 002 A070022 001 A070032 001 A076899 A076899 A090624 A090624 A090828 A090828 A071017 A078060 A078060 A076817 A076817 001 002 001 002 002 001 001 002 001 001 002 Feb 15, 1985 Feb 15, 1985 Jan Jan Feb Feb Dec Dec Aug Jan Jan Oct Oct 27, 27, 16, 16, 22, 22, 25, 25, 25, 07, 07, 2005 2005 2010 2010 2010 2010 1986 2007 2007 2005 2005

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

SULFAMETHOXAZOLE; TRIMETHOPRIM
TABLET; ORAL SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH SANDOZ AB 800MG;160MG TEVA AB 800MG;160MG SULFAMETHOXAZOLE AND TRIMETHOPRIM SINGLE STRENGTH PLANTEX AB 400MG;80MG

3 - 383 (of 424)

N018598 004 A070037 001 A070030 001

May 19, 1982 Jun 02, 1987 Jun 02, 1987

SULFANILAMIDE
CREAM; VAGINAL

AVC

XX + AZUR PHARMA

15%

N006530 003

Jan 27, 1987

SULFASALAZINE
SUSPENSION; ORAL

AZULFIDINE

XX + PHARMACIA AND UPJOHN TABLET; ORAL AZULFIDINE AB + PHARMACIA AND UPJOHN SULFASALAZINE VINTAGE PHARMS AB WATSON LABS AB AB

250MG/5ML

A086983 001

500MG 500MG 500MG 500MG

N007073 001 A040349 001 A085828 001 A087197 001 Jan 11, 2002

TABLET, DELAYED RELEASE; ORAL AZULFIDINE EN-TABS AB + PHARMACIA AND UPJOHN 500MG SULFASALAZINE VINTAGE PHARMS AB 500MG

N007073 002 A075339 001

Apr 06, 1983 Jan 11, 2002

SULINDAC
TABLET; ORAL CLINORIL AB + MERCK SULINDAC EPIC PHARMA AB AB MUTUAL PHARM AB AB MYLAN AB AB WATSON LABS AB AB

200MG 150MG 200MG 150MG 200MG 150MG 200MG 150MG 200MG

N017911 002 A072710 A072711 A072050 A072051 A073039 A073039 A071891 A071795 001 001 001 001 002 001 001 001 Mar Mar Apr Apr Jun Jun Apr Apr 25, 25, 17, 17, 22, 22, 03, 03, 1991 1991 1991 1991 1993 1993 1990 1990

SUMATRIPTAN
SPRAY; NASAL

IMITREX

XX + GLAXOSMITHKLINE XX +

5MG/SPRAY 20MG/SPRAY

N020626 001 N020626 003

Aug 26, 1997 Aug 26, 1997

SUMATRIPTAN SUCCINATE
INJECTABLE; SUBCUTANEOUS IMITREX STATDOSE AB + GLAXOSMITHKLINE SUMATRIPTAN SUCCINATE SUN PHARM INDS INC AB IMITREX AP + GLAXOSMITHKLINE

EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)

N020080 003 A090358 001 N020080 001

Dec 23, 1996 Jun 21, 2011 Dec 28, 1992

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

SUMATRIPTAN SUCCINATE
INJECTABLE; SUBCUTANEOUS SUMATRIPTAN SUCCINATE APP PHARMS AP AP AP BEDFORD AP BEDFORD LABS AP JHP PHARMS AP PAR PHARM AP SAGENT STRIDES AP AP SANDOZ AP AP TEVA PARENTERAL AP WOCKHARDT AP ALSUMA XX + MERIDIAN MEDCL IMITREX STATDOSE XX + GLAXOSMITHKLINE SUMAVEL DOSEPRO XX + ZOGENIX INC TABLET; ORAL IMITREX GLAXOSMITHKLINE AB AB AB + SUMATRIPTAN SUCCINATE AUROBINDO PHARMA AB AB AB DR REDDYS LABS INC AB AB AB MYLAN AB AB AB AB AB AB ORCHID HLTHCARE AB AB AB RANBAXY AB AB AB SANDOZ AB AB AB SUN PHARM INDS AB AB AB TEVA AB AB AB WATSON LABS AB AB AB

3 - 384 (of 424)

EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ

6MG 6MG 4MG 6MG 6MG 6MG 6MG 6MG 6MG 4MG 6MG 6MG 6MG

BASE/0.5ML BASE/0.5ML BASE/0.5ML BASE/0.5ML BASE/0.5ML BASE/0.5ML BASE/0.5ML BASE/0.5ML BASE/0.5ML BASE/0.5ML BASE/0.5ML BASE/0.5ML BASE/0.5ML

(EQ (EQ (EQ (EQ (EQ (EQ (EQ (EQ (EQ (EQ (EQ (EQ (EQ

12MG BASE/ML) 12MG BASE/ML) 8MG BASE/ML) 12MG BASE/ML) 12MG BASE/ML) 12MG BASE/ML) 12MG BASE/ML) 12MG BASE/ML) 12MG BASE/ML) 8MG BASE/ML) 12MG BASE/ML) 12MG BASE/ML) 12MG BASE/ML)

A079242 A079240 A079240 A079123 A090310 A077871 A077332 A090314 A090641 A078067 A078067 A077907 A078593

001 002 001 001 001 001 001 001 001 002 001 001 001

Mar Sep Sep Feb Aug Jul Oct Jun Jul Feb Feb Feb Feb

02, 18, 18, 06, 11, 09, 09, 10, 28, 06, 06, 06, 06,

2009 2009 2009 2009 2010 2009 2009 2010 2010 2009 2009 2009 2009

EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)

N022377 001 N020080 002 N022239 001

Jun 29, 2010 Feb 01, 2006 Jul 15, 2009

EQ 25MG BASE EQ 50MG BASE EQ 100MG BASE EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ 25MG BASE 50MG BASE 100MG BASE 25MG BASE 50MG BASE 100MG BASE 25MG BASE 25MG BASE 50MG BASE 50MG BASE 100MG BASE 100MG BASE 25MG BASE 50MG BASE 100MG BASE 25MG BASE 50MG BASE 100MG BASE 25MG BASE 50MG BASE 100MG BASE 25MG BASE 50MG BASE 100MG BASE 25MG BASE 50MG BASE 100MG BASE 25MG BASE 50MG BASE 100MG BASE

N020132 002 N020132 003 N020132 001 A078327 A078327 A078327 A076847 A076847 A076847 A077163 A077744 A077163 A077744 A077163 A077744 A078284 A078284 A078284 A076554 A076554 A076572 A076976 A076976 A076976 A078295 A078295 A078295 A076840 A076840 A076840 A076933 A076933 A076933 001 002 003 001 002 003 001 001 002 002 003 003 001 002 003 001 002 001 001 002 003 001 002 003 001 002 003 001 002 003

Jun 01, 1995 Jun 01, 1995 Jun 01, 1995 Aug Aug Aug Aug Aug Aug Nov Aug Nov Aug Nov Aug Aug Aug Aug Aug Aug Feb Aug Aug Aug Aug Aug Aug Feb Feb Feb Aug Aug Aug 10, 10, 10, 10, 10, 10, 02, 10, 02, 10, 02, 10, 10, 10, 10, 10, 10, 09, 10, 10, 10, 10, 10, 10, 09, 09, 09, 10, 10, 10, 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

SUNITINIB MALATE
CAPSULE; ORAL SUTENT CPPI CV XX XX XX XX +

3 - 385 (of 424)

EQ EQ EQ EQ

12.5MG BASE 25MG BASE 37.5MG BASE 50MG BASE

N021938 N021938 N021938 N021938

001 002 004 003

Jan Jan Mar Jan

26, 26, 31, 26,

2006 2006 2009 2006

TACROLIMUS
CAPSULE; ORAL PROGRAF ASTELLAS AB AB AB + TACROLIMUS ACCORD HLTHCARE AB AB AB DR REDDYS LABS LTD AB AB AB MYLAN AB AB AB SANDOZ AB AB AB WATSON LABS AB INJECTABLE; INJECTION

PROGRAF

XX + ASTELLAS OINTMENT; TOPICAL PROTOPIC ASTELLAS XX XX +

EQ 0.5MG BASE EQ 1MG BASE EQ 5MG BASE 0.5MG 1MG 5MG EQ 0.5MG BASE EQ 1MG BASE EQ 5MG BASE EQ 0.5MG BASE EQ 1MG BASE EQ 5MG BASE EQ 0.5MG BASE EQ 1MG BASE EQ 5MG BASE EQ 5MG BASE

N050708 003 N050708 001 N050708 002 A091195 A091195 A091195 A090509 A090509 A090509 A090596 A090596 A090596 A065461 A065461 A065461 A090402 001 002 003 001 002 003 001 002 003 001 002 003 001

Aug 24, 1998 Apr 08, 1994 Apr 08, 1994 Aug Aug Aug May May May Sep Sep Sep Aug Aug Aug Jul 31, 31, 31, 12, 12, 12, 17, 17, 17, 10, 10, 10, 01, 2011 2011 2011 2010 2010 2010 2010 2010 2010 2009 2009 2009 2010

EQ 5MG BASE/ML

N050709 001

Apr 08, 1994

0.03% 0.1%

N050777 001 N050777 002

Dec 08, 2000 Dec 08, 2000

TADALAFIL
TABLET; ORAL

ADCIRCA

XX + ELI LILLY CO CIALIS LILLY XX XX XX XX +

20MG 2.5MG 5MG 10MG 20MG

N022332 001 N021368 N021368 N021368 N021368 004 001 002 003

May 22, 2009 Jan Nov Nov Nov 07, 21, 21, 21, 2008 2003 2003 2003

TALC
AEROSOL, METERED; INTRAPLEURAL

SCLEROSOL

400MG/SPRAY XX + BRYAN POWDER; INTRAPLEURAL

TALC

XX + BRYAN

N020587 001

Dec 24, 1997

5GM/BOT

N021388 001

Dec 15, 2003

TAMOXIFEN CITRATE
TABLET; ORAL TAMOXIFEN CITRATE AEGIS PHARMS AB AB

EQ 10MG BASE EQ 20MG BASE

A076398 001 A076398 002

Mar 31, 2003 Mar 31, 2003

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

TAMOXIFEN CITRATE
TABLET; ORAL TAMOXIFEN CITRATE APOTEX AB AB MYLAN AB AB TEVA AB AB + TEVA PHARMS WATSON LABS AB AB WATSON LABS FLORIDA AB AB

3 - 386 (of 424)

EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ

10MG 20MG 10MG 20MG 10MG 20MG 10MG 20MG 10MG 20MG

BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE

A090878 A090878 A074732 A074732 A075797 A074858 A070929 A070929 A076179 A076179

001 002 002 001 001 001 001 002 001 002

Sep Sep Feb Feb Feb Feb Feb Feb Feb Feb

23, 23, 20, 20, 20, 20, 20, 20, 20, 20,

2011 2011 2003 2003 2003 2003 2003 2003 2003 2003

TAMSULOSIN HYDROCHLORIDE
CAPSULE; ORAL FLOMAX + BOEHRINGER INGELHEIM 0.4MG TAMSULOSIN HYDROCHLORIDE IMPAX LABS 0.4MG MYLAN 0.4MG SANDOZ 0.4MG SUN PHARM INDS LTD 0.4MG SYNTHON PHARMS 0.4MG TEVA PHARMS 0.4MG WOCKHARDT 0.4MG ZYDUS PHARMS USA INC 0.4MG

AB AB AB AB AB AB AB AB AB

N020579 001 A090377 A090408 A078015 A090931 A078801 A077630 A078938 A078225 001 001 001 001 001 001 001 001

Apr 15, 1997 Mar Apr Apr Jul Apr Apr Apr Apr 02, 27, 27, 15, 27, 27, 27, 27, 2010 2010 2010 2010 2010 2010 2010 2010

TAPENTADOL HYDROCHLORIDE
TABLET; ORAL NUCYNTA JANSSEN PHARMS XX XX XX +

EQ 50MG BASE EQ 75MG BASE EQ 100MG BASE

N022304 001 N022304 002 N022304 003

Nov 20, 2008 Nov 20, 2008 Nov 20, 2008

TABLET, EXTENDED RELEASE; ORAL NUCYNTA ER JANSSEN PHARMS EQ 50MG BASE XX EQ 100MG BASE XX EQ 150MG BASE XX EQ 200MG BASE XX EQ 250MG BASE XX +

N200533 N200533 N200533 N200533 N200533

001 002 003 004 005

Aug Aug Aug Aug Aug

25, 25, 25, 25, 25,

2011 2011 2011 2011 2011

TAZAROTENE
CREAM; TOPICAL

AVAGE

XX + ALLERGAN TAZORAC XX + ALLERGAN XX + GEL; TOPICAL

TAZORAC

XX + ALLERGAN XX +

0.1% 0.05% 0.1%

N021184 003 N021184 001 N021184 002

Sep 30, 2002 Sep 29, 2000 Sep 29, 2000

0.05% 0.1%

N020600 001 N020600 002

Jun 13, 1997 Jun 13, 1997

TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT

INJECTABLE; INJECTION PULMOLITE BS PHARMALUCENCE

N/A

N017776 001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT
INJECTABLE; INJECTION TECHNETIUM TC 99M ALBUMIN AGGREGATED KIT BS DRAXIMAGE N/A

3 - 387 (of 424)

N017881 001

Dec 30, 1987

TECHNETIUM TC-99M BICISATE KIT

INJECTABLE; INJECTION NEUROLITE LANTHEUS MEDCL XX

N/A

N020256 001

Nov 23, 1994

TECHNETIUM TC-99M DISOFENIN KIT

INJECTABLE; INJECTION HEPATOLITE PHARMALUCENCE XX

N/A

N018467 001

Mar 16, 1982

TECHNETIUM TC-99M EXAMETAZIME KIT

INJECTABLE; INJECTION
CERETEC
XX + GE HEALTHCARE

N/A

N019829 001

Dec 30, 1988

TECHNETIUM TC-99M MEBROFENIN KIT

INJECTABLE; INJECTION CHOLETEC AP + BRACCO N/A TECHNETIUM TC-99M MEBROFENIN PHARMALUCENCE AP N/A

N018963 001 A078242 001

Jan 21, 1987 Jan 29, 2008

TECHNETIUM TC-99M MEDRONATE

INJECTABLE; INJECTION
DRAXIMAGE MDP-25
XX + DRAXIMAGE

N/A

N018035 002

Feb 27, 2004

TECHNETIUM TC-99M MEDRONATE KIT

INJECTABLE; INJECTION CIS-MDP PHARMALUCENCE AP MDP-BRACCO BRACCO AP

N/A N/A

N018124 001 N018107 001

TECHNETIUM TC-99M MERTIATIDE KIT

INJECTABLE; INJECTION
TECHNESCAN MAG3
XX + MALLINCKRODT

N/A

N019882 001

Jun 15, 1990

TECHNETIUM TC-99M OXIDRONATE KIT

INJECTABLE; INJECTION
TECHNESCAN
XX + MALLINCKRODT

N/A

N018321 001

TECHNETIUM TC-99M PENTETATE KIT

INJECTABLE; INJECTION AN-DTPA PHARMALUCENCE AP DTPA DRAXIMAGE AP

N/A N/A

N017714 001 N018511 001 Dec 29, 1989

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

TECHNETIUM TC-99M PYROPHOSPHATE KIT
INJECTABLE; INJECTION CIS-PYRO PHARMALUCENCE AP TECHNESCAN PYP KIT MALLINCKRODT AP

3 - 388 (of 424)

N/A N/A

N019039 001 N017538 001

Jun 30, 1987

TECHNETIUM TC-99M RED BLOOD CELL KIT

INJECTABLE; INJECTION ULTRATAG MALLINCKRODT XX

N/A

N019981 001

Jun 10, 1991

TECHNETIUM TC-99M SESTAMIBI KIT

INJECTABLE; INJECTION CARDIOLITE + LANTHEUS MEDCL N/A TECHNETIUM TC 99M SESTAMIBI CARDINAL HEALTH 414 N/A DRAXIMAGE N/A PHARMALUCENCE 10-30mCi TECHNETIUM TC-99 SESTAMIBI MALLINCKRODT N/A

AP AP AP AP AP

N019785 001 A078809 001 A078806 001 A079157 001 A078098 001

Dec 21, 1990 Apr 28, 2009 Apr 29, 2009 Jul 10, 2009 Sep 22, 2008

TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR

SOLUTION; INJECTION, ORAL

TECHNELITE
0.0083-2.7 CI/GENERATOR XX + LANTHEUS MEDCL ULTRA-TECHNEKOW FM
0.25-3 CI/GENERATOR XX + MALLINCKRODT

N017771 001
N017243 002

TECHNETIUM TC-99M SUCCIMER KIT

INJECTABLE; INJECTION
MPI DMSA KIDNEY REAGENT
XX GE HEALTHCARE N/A

N017944 001

May 18, 1982

TECHNETIUM TC-99M SULFUR COLLOID KIT

SOLUTION; INJECTION, ORAL

AN-SULFUR COLLOID
N/A XX + PHARMALUCENCE

N017858 001

TECHNETIUM TC-99M TETROFOSMIN KIT

INJECTABLE; INJECTION
MYOVIEW
XX + GE HEALTHCARE MYOVIEW 30ML XX + GE HEALTHCARE

N/A N/A

N020372 001 N020372 002

Feb 09, 1996 Jul 07, 2005

TELAPREVIR

TABLET; ORAL

INCIVEK
XX + VERTEX PHARMS

375MG

N201917 001

May 23, 2011

TELAVANCIN HYDROCHLORIDE
POWDER; IV (INFUSION) VIBATIV THERAVANCE INC XX XX +

EQ 250MG BASE/VIAL EQ 750MG BASE/VIAL

N022110 001 N022110 002

Sep 11, 2009

Sep 11, 2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

TELBIVUDINE
TABLET; ORAL
TYZEKA
XX + NOVARTIS

3 - 389 (of 424)

600MG

N022011 001

Oct 25, 2006

TELITHROMYCIN
TABLET; ORAL KETEK SANOFI AVENTIS US XX XX +

300MG 400MG

N021144 002 N021144 001

Feb 09, 2005 Apr 01, 2004

TELMISARTAN
TABLET; ORAL MICARDIS XX BOEHRINGER INGELHEIM XX XX +

20MG 40MG 80MG

N020850 003 N020850 001 N020850 002

Apr 04, 2000 Nov 10, 1998 Nov 10, 1998

TEMAZEPAM
CAPSULE; ORAL RESTORIL MALLINCKRODT INC AB AB AB AB + TEMAZEPAM ACTAVIS ELIZABETH AB AB MUTUAL PHARM AB AB MYLAN AB AB AB AB NOVEL LABS INC AB AB SANDOZ AB AB WATSON LABS AB AB

7.5MG 15MG 22.5MG 30MG 15MG 30MG 7.5MG 22.5MG 7.5MG 15MG 22.5MG 30MG 15MG 30MG 15MG 30MG 15MG 30MG

N018163 N018163 N018163 N018163 A071638 A071620 A078581 A071175 A070920 A070920 A070920 A070920 A071456 A071457 A071427 A071428 A071446 A071447

003 001 004 002 001 001 001 002 002 004 003 001 001 001 001 001 001 001

Oct 25, 1991 Nov 02, 2004

Aug Aug Sep Sep May Jul Jun Jul Apr Apr Jan Jan May May

07, 07, 08, 14, 21, 07, 12, 10, 21, 21, 12, 12, 21, 21,

1987 1987 2009 2009 2010 1986 2009 1986 1987 1987 1988 1988 1993 1993

TEMOZOLOMIDE
CAPSULE; ORAL TEMODAR SCHERING AB AB AB AB AB AB + TEMOZOLOMIDE BARR AB AB AB AB AB AB

5MG 20MG 100MG 140MG 180MG 250MG 5MG 20MG 100MG 140MG 180MG 250MG

N021029 N021029 N021029 N021029 N021029 N021029 A078879 A078879 A078879 A078879 A078879 A078879

001 002 003 005 006 004 001 002 003 005 006 004

Aug Aug Aug Oct Oct Aug Mar Mar Mar Mar Mar Mar

11, 11, 11, 19, 19, 11, 01, 01, 01, 01, 01, 01,

1999 1999 1999 2006 2006 1999 2010 2010 2010 2010 2010 2010

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

TEMOZOLOMIDE
POWDER; INTRAVENOUS

TEMODAR

XX + SCHERING

3 - 390 (of 424)

100MG/VIAL

N022277 001

Feb 27, 2009

TEMSIROLIMUS
SOLUTION; INTRAVENOUS

TORISEL

XX + WYETH PHARMS INC

25MG/ML (25MG/ML)

N022088 001

May 30, 2007

TENIPOSIDE
INJECTABLE; INJECTION

VUMON

XX + BRISTOL MYERS SQUIBB

10MG/ML

N020119 001

Jul 14, 1992

TENOFOVIR DISOPROXIL FUMARATE

TABLET; ORAL

VIREAD

XX + GILEAD

300MG

N021356 001

Oct 26, 2001

TERAZOSIN HYDROCHLORIDE
CAPSULE; ORAL HYTRIN ABBOTT AB AB + AB AB TERAZOSIN HYDROCHLORIDE APOTEX AB AB AB AB IVAX SUB TEVA PHARMS AB AB AB AB JUBILANT CADISTA AB AB AB AB MYLAN AB AB AB AB RANBAXY AB AB AB AB SANDOZ AB AB AB AB TABLET; ORAL HYTRIN ABBOTT XX XX + XX XX

EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ

1MG BASE 2MG BASE 5MG BASE 10MG BASE 1MG BASE 2MG BASE 5MG BASE 10MG BASE 1MG BASE 2MG BASE 5MG BASE 10MG BASE 1MG BASE 2MG BASE 5MG BASE 10MG BASE 1MG BASE 2MG BASE 5MG BASE 10MG BASE 1MG BASE 2MG BASE 5MG BASE 10MG BASE 1MG BASE 2MG BASE 5MG BASE 10MG BASE

N020347 N020347 N020347 N020347 A075498 A075498 A075498 A075498 A075614 A075614 A075614 A075614 A075317 A075317 A075317 A075317 A075140 A075140 A075140 A075140 A076021 A076021 A076021 A076021 A074823 A074823 A074823 A074823

001 002 003 004 001 002 003 004 002 001 003 004 001 002 003 004 002 003 001 004 001 002 003 004 001 002 003 004

Dec Dec Dec Dec Apr Apr Apr Apr Jan Jan Jan Jan Dec Dec Dec Dec Feb Feb Feb Feb Aug Aug Aug Aug Mar Mar Mar Mar

14, 14, 14, 14, 12, 12, 12, 12, 30, 30, 30, 30, 20, 20, 20, 20, 11, 11, 11, 11, 22, 22, 22, 22, 30, 30, 30, 30,

1994 1994 1994 1994 2001 2001 2001 2001 2001 2001 2001 2001 2004 2004 2004 2004 2000 2000 2000 2000 2002 2002 2002 2002 1998 1998 1998 1998

EQ EQ EQ EQ

1MG BASE 2MG BASE 5MG BASE 10MG BASE

N019057 N019057 N019057 N019057

001 002 003 004

Aug Aug Aug Aug

07, 07, 07, 07,

1987 1987 1987 1987

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

TERBINAFINE HYDROCHLORIDE
GRANULE; ORAL LAMISIL NOVARTIS XX XX +

3 - 391 (of 424)

EQ 125MG BASE/PACKET EQ 187.5MG BASE/PACKET

N022071 001 N022071 002

Sep 28, 2007 Sep 28, 2007

AB AB AB AB AB AB AB AB AB AB AB AB AB AB

TABLET; ORAL LAMISIL + NOVARTIS EQ TERBINAFINE HYDROCHLORIDE APOTEX EQ AUROBINDO PHARMA EQ BRECKENRIDGE PHARM EQ DR REDDYS LABS INC EQ GLENMARK GENERICS EQ HARRIS PHARM EQ INVAGEN PHARMS EQ MYLAN EQ EQ ORCHID HLTHCARE EQ TEVA EQ WATSON LABS EQ WOCKHARDT EQ

250MG BASE 250MG 250MG 250MG 250MG 250MG 250MG 250MG 250MG 250MG 250MG 250MG 250MG 250MG BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE

N020539 001 A078199 A078297 A077714 A076390 A078157 A077919 A077533 A077136 A077195 A078163 A076377 A077137 A078229 001 001 001 001 001 001 001 001 001 001 001 001 001

May 10, 1996 Jul Jul Jun Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul 02, 02, 04, 02, 02, 02, 02, 02, 02, 02, 02, 02, 02, 2007 2007 2010 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007

TERBUTALINE SULFATE
INJECTABLE; INJECTION TERBUTALINE SULFATE AKORN APP PHARMS + BEDFORD HIKMA FARMACEUTICA TEVA PARENTERAL

AP AP AP AP AP

1MG/ML 1MG/ML 1MG/ML 1MG/ML 1MG/ML

A078151 A076887 A076770 A078630 A076853

001 001 001 001 001

Jan May Apr May Jul

07, 26, 23, 20, 20,

2008 2004 2004 2009 2004

TABLET; ORAL TERBUTALINE SULFATE IMPAX LABS AB AB + LANNETT AB AB

2.5MG 5MG 2.5MG 5MG

A075877 A075877 A077152 A077152

001 002 001 002

Jun Jun Mar Mar

26, 26, 25, 25,

2001 2001 2005 2005

TERCONAZOLE
CREAM; VAGINAL TERAZOL 3 + JANSSEN PHARMS TERAZOL 7 + JANSSEN PHARMS TERCONAZOLE ALTANA TARO TERCONAZOLE + NYCOMED US SUPPOSITORY; VAGINAL TERAZOL 3 + JANSSEN PHARMS TERCONAZOLE ALTANA PERRIGO NEW YORK TARO

AB AB AB AB AB BX

0.8% 0.4% 0.4% 0.4% 0.8% 0.8%

N019964 001 N019579 001 A076712 001 A076043 001 A075953 001 N021735 001

Feb 21, 1991 Dec 31, 1987 Feb 18, 2005 Jan 19, 2005 Apr 06, 2004 Oct 01, 2004

AB AB AB AB

80MG 80MG 80MG 80MG

N019641 001 A076850 001 A077149 001 A077553 001

May 24, 1988 Jul 12, 2006 Mar 17, 2006 Mar 09, 2007

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

TERIPARATIDE RECOMBINANT HUMAN
INJECTABLE; SUBCUTANEOUS

FORTEO

XX + LILLY

3 - 392 (of 424)

0.6MG/2.4ML (0.25MG/ML)

N021318 002

Jun 25, 2008

TESAMORELIN ACETATE
POWDER; SUBCUTANEOUS

EGRIFTA

XX + THERATECHNOLOGIES

EQ 1MG BASE/VIAL

N022505 001

Nov 10, 2010

TESTOSTERONE
FILM, EXTENDED RELEASE; TRANSDERMAL
ANDRODERM
XX + WATSON LABS
2MG/24HR XX +
4MG/24HR GEL; TRANSDERMAL ANDROGEL BX + ABBOTT LABS TESTIM BX + AUXILIUM PHARMS ANDROGEL ABBOTT LABS XX

N020489 003 N020489 004

Oct 20, 2011 Oct 20, 2011

1% (5GM/PACKET) 1% (5GM/PACKET) 1% (2.5GM/PACKET)

N021015 002 N021454 001 N021015 001

Feb 28, 2000 Oct 31, 2002 Feb 28, 2000

GEL, METERED; TRANSDERMAL

ANDROGEL
1% (1.25GM/ACTIVATION) XX + ABBOTT LABS 1.62% (20.25MG/1.25GM ACTIVATION) XX +
FORTESTA
10MG/0.5GM ACTIVATION XX + ENDO PHARMS PELLET; IMPLANTATION
TESTOPEL
XX + SLATE PHARMS

N021015 003 N022309 001 N021463 001

Sep 26, 2003 Apr 29, 2011 Dec 29, 2010

75MG

A080911 001

SOLUTION, METERED; TRANSDERMAL

AXIRON
30MG/1.5ML ACTIVATION XX + ELI LILLY AND CO TABLET, EXTENDED RELEASE; BUCCAL
STRIANT
30MG XX + ACTIENT PHARMS

N022504 001

Nov 23, 2010

N021543 001

Jun 19, 2003

TESTOSTERONE CYPIONATE
INJECTABLE; INJECTION DEPO-TESTOSTERONE AO + PHARMACIA AND UPJOHN AO + TESTOSTERONE CYPIONATE BEDFORD AO AO PADDOCK LLC AO SANDOZ AO AO SYNERX PHARMA AO WATSON LABS AO

100MG/ML 200MG/ML 100MG/ML 200MG/ML 200MG/ML 100MG/ML 200MG/ML 200MG/ML 200MG/ML

A085635 002 A085635 003 A090387 A090387 A040530 A040615 A040615 A040652 A086030 001 002 001 001 002 001 001 Jul Jul Jan Aug Aug Dec 15, 15, 31, 10, 10, 11, 2010 2010 2005 2006 2006 2006

TESTOSTERONE ENANTHATE
INJECTABLE; INJECTION DELATESTRYL AO + ENDO PHARM TESTOSTERONE ENANTHATE PADDOCK LLC AO SYNERX PHARMA AO

200MG/ML 200MG/ML 200MG/ML

N009165 003 A040575 001 A040647 001 Jun 14, 2006 Oct 05, 2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

TESTOSTERONE ENANTHATE
INJECTABLE; INJECTION TESTOSTERONE ENANTHATE WATSON LABS AO

3 - 393 (of 424)

200MG/ML

A085598 001

TETRABENAZINE
TABLET; ORAL XENAZINE VALEANT INTL XX XX +

12.5MG 25MG

N021894 001 N021894 002

Aug 15, 2008 Aug 15, 2008

TETRACYCLINE HYDROCHLORIDE
CAPSULE; ORAL TETRACYCLINE HYDROCHLORIDE IMPAX LABS AB 250MG AB 500MG IVAX SUB TEVA PHARMS 250MG AB AB + 500MG WATSON LABS AB 250MG AB 500MG
TETRACYCLINE HYDROCHLORIDE
IMPAX LABS 100MG XX

A060469 A060469 A060704 A060704 A061837 A061837

001 003 001 002 001 002

A060469 002

TETRAHYDROZOLINE HYDROCHLORIDE

SOLUTION; NASAL

TYZINE
XX + NYCOMED US XX
SPRAY; NASAL

TYZINE
XX + NYCOMED US

0.05% 0.1%

A086576 002

A086576 001

0.1%

A086576 003

THALIDOMIDE
CAPSULE; ORAL THALOMID CELGENE XX XX XX XX +

50MG 100MG 150MG 200MG

N020785 N020785 N020785 N020785

001 002 004 003

Jul Jan Jan Jan

16, 17, 10, 17,

1998 2003 2007 2003

THALLOUS CHLORIDE TL-201

INJECTABLE; INJECTION THALLOUS CHLORIDE TL 201 AP + GE HEALTHCARE 1mCi/ML AP + LANTHEUS MEDCL 1mCi/ML AP + MALLINCKRODT 1mCi/ML INJECTABLE; INTRAVENOUS THALLOUS CHLORIDE TL 201 AP + LANTHEUS MEDCL 2mCi/ML MALLINCKRODT AP 2mCi/ML

N018110 002 N017806 001 N018150 001

Feb 27, 1996

N017806 002 A077698 001

Oct 09, 1998 Nov 09, 2006

THEOPHYLLINE
CAPSULE, EXTENDED RELEASE; ORAL THEO-24 BC UCB INC 100MG BC 200MG BC 300MG THEOPHYLLINE BC INWOOD LABS 100MG

A087942 001 A087943 001 A087944 001 A040052 001

Aug 22, 1983 Aug 22, 1983 Aug 22, 1983 Feb 14, 1994

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

THEOPHYLLINE
CAPSULE, EXTENDED RELEASE; ORAL THEOPHYLLINE INWOOD LABS 200MG + 300MG THEO-24 UCB INC 400MG THEOPHYLLINE INWOOD LABS 125MG

3 - 394 (of 424)

BC BC XX XX

A040052 003 A040052 004 A081034 001 A040052 002

Feb 14, 1994 Feb 14, 1994 Feb 28, 1992 Feb 14, 1994

ELIXIR; ORAL

ELIXOPHYLLIN

XX + CARACO

80MG/15ML

A085186 001

AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP

INJECTABLE; INJECTION THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER + B BRAUN 40MG/100ML THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER + B BRAUN 80MG/100ML THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER + B BRAUN 160MG/100ML THEOPHYLLINE 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER + B BRAUN 320MG/100ML THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER + BAXTER HLTHCARE 4MG/ML + 40MG/100ML + 80MG/100ML + 160MG/100ML + 200MG/100ML + 320MG/100ML + 400MG/100ML THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER + HOSPIRA INC 4MG/ML + 40MG/100ML + 160MG/100ML + 320MG/100ML

N019826 001 N019826 002 N019826 003 N019826 006 N018649 N018649 N018649 N018649 N018649 N018649 N018649 N019211 N019211 N019211 N019211 007 001 002 003 004 006 005 007 001 003 006

Aug 14, 1992 Aug 14, 1992 Aug 14, 1992 Aug 14, 1992 Jul Jul Jul Jul Jul Nov Jul Dec Dec Dec Jan 26, 26, 26, 26, 26, 13, 26, 14, 14, 14, 20, 1982 1982 1982 1982 1982 1985 1982 1984 1984 1984 1988

SOLUTION; ORAL

THEOPHYLLINE

XX + SILARX TABLET; ORAL

THEOLAIR

XX + GRACEWAY XX +

80MG/15ML

A091156 001

Apr 13, 2011

125MG 250MG

A086399 001 A086399 002

TABLET, EXTENDED RELEASE; ORAL THEOCHRON CARACO AB 100MG AB 200MG AB 300MG THEOPHYLLINE ALEMBIC LTD AB 300MG AB 450MG GLENMARK GENERICS AB 400MG AB 600MG INWOOD LABS AB 450MG NOSTRUM AB 400MG AB + 600MG AB + PLIVA 100MG AB + 200MG AB 300MG AB + 450MG

A088320 001 A088321 001 A087400 002 A090430 A090430 A090355 A090355 A040034 A040595 A040560 A089807 A089808 A089763 A081236 001 002 001 002 001 001 002 001 001 001 001

Feb 21, 1985 Feb 21, 1985 Jan 11, 1983 Oct Oct Jul Jul Apr Apr Apr Apr Apr Apr Nov 27, 27, 13, 13, 28, 21, 21, 30, 30, 30, 09, 2010 2010 2010 2010 1995 2006 2006 1990 1990 1990 1992

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

THIAMINE HYDROCHLORIDE
INJECTABLE; INJECTION THIAMINE HYDROCHLORIDE AP + APP PHARMS WATSON LABS AP THIAMINE HYDROCHLORIDE XX + WATSON LABS

3 - 395 (of 424)

100MG/ML 100MG/ML 200MG/ML

A080556 001 A080571 001 A080571 002

THIOGUANINE
TABLET; ORAL
THIOGUANINE
XX + GLAXOSMITHKLINE

40MG

N012429 001

THIORIDAZINE HYDROCHLORIDE
TABLET; ORAL THIORIDAZINE HYDROCHLORIDE MUTUAL PHARM 10MG 25MG 50MG 100MG MYLAN 10MG 25MG 50MG + 100MG

AB AB AB AB AB AB AB AB

A089953 A089953 A089953 A089953 A088004 A088004 A088004 A088004

004 003 002 001 002 003 004 001

Aug Aug Aug Oct Mar Mar Mar Nov

01, 01, 01, 07, 15, 15, 15, 18,

1986 1986 1986 1988 1983 1983 1983 1983

THIOTEPA
INJECTABLE; INJECTION THIOTEPA XX BEDFORD

15MG/VIAL

A075547 001

Apr 02, 2001

THIOTHIXENE
CAPSULE; ORAL NAVANE PFIZER AB AB AB + AB THIOTHIXENE MYLAN AB AB AB AB SANDOZ AB AB AB AB WATSON LABS AB AB

1MG 2MG 5MG 10MG 1MG 2MG 5MG 10MG 1MG 2MG 5MG 10MG 2MG 5MG

N016584 N016584 N016584 N016584 A071093 A071093 A071093 A071093 A071610 A071570 A071529 A071530 A070601 A070602

001 002 003 004 002 003 004 001 001 001 001 001 001 001 Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun 23, 23, 23, 23, 24, 24, 24, 24, 05, 05, 1987 1987 1987 1987 1987 1987 1987 1987 1987 1987

THYROTROPIN ALFA
INJECTABLE; INJECTION
THYROGEN
XX + GENZYME

1.1MG/VIAL

N020898 001

Nov 30, 1998

TIAGABINE HYDROCHLORIDE
TABLET; ORAL GABITRIL CEPHALON AB AB +

2MG 4MG

N020646 005 N020646 001

Apr 16, 1999

Sep 30, 1997

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

TIAGABINE HYDROCHLORIDE
TABLET; ORAL TIAGABINE HYDROCHLORIDE SUN PHARM INDS AB 2MG AB 4MG GABITRIL CEPHALON 6MG XX 8MG XX 10MG XX 12MG XX 16MG XX

3 - 396 (of 424)

A077555 001 A077555 002 N020646 N020646 N020646 N020646 N020646 006 007 008 002 003

Nov 04, 2011 Nov 04, 2011 Nov Nov Nov Sep Sep 29, 29, 29, 30, 30, 2005 2005 2005 1997 1997

TICAGRELOR
TABLET; ORAL

BRILINTA

XX + ASTRAZENECA LP

90MG

N022433 001

Jul 20, 2011

TICLOPIDINE HYDROCHLORIDE
TABLET; ORAL TICLOPIDINE HYDROCHLORIDE APOTEX 250MG CARACO 250MG MYLAN 250MG SANDOZ 250MG + TEVA 250MG

AB AB AB AB AB

A075089 A075526 A075161 A075326 A075149

001 001 001 001 001

Jul Sep Sep Aug Aug

01, 26, 13, 20, 20,

1999 2002 1999 1999 1999

TIGECYCLINE
INJECTABLE; IV (INFUSION)

TYGACIL

50MG/VIAL XX + WYETH PHARMS INC

N021821 001

Jun 15, 2005

TILUDRONATE DISODIUM
TABLET; ORAL

SKELID

XX + SANOFI AVENTIS US

EQ 200MG BASE

N020707 001

Mar 07, 1997

TIMOLOL
SOLUTION/DROPS; OPHTHALMIC
BETIMOL
XX + SANTEN OY EQ 0.25% BASE XX + EQ 0.5% BASE

N020439 001 N020439 002

Mar 31, 1995 Mar 31, 1995

TIMOLOL MALEATE
SOLUTION, GEL FORMING/DROPS; TIMOLOL MALEATE FALCON PHARMS EQ EQ TIMOPTIC-XE + ATON EQ + EQ SOLUTION/DROPS; OPHTHALMIC TIMOLOL MALEATE AKORN EQ EQ EQ APOTEX INC EQ EQ BAUSCH AND LOMB EQ EQ OPHTHALMIC 0.25% BASE 0.5% BASE 0.25% BASE 0.5% BASE N020963 001 N020963 002 N020330 001 N020330 002 Oct 21, 1998 Oct 21, 1998 Nov 04, 1993 Nov 04, 1993

AB AB AB AB

AT AT AT AT AT AT AT

0.25% BASE 0.5% BASE 0.5% BASE 0.25% BASE 0.5% BASE 0.25% BASE 0.5% BASE

A074515 A074466 A074516 A075411 A075412 A074778 A074776

001 001 001 001 001 001 001

Mar Mar Mar Sep Sep Mar Mar

25, 25, 25, 08, 08, 25, 25,

1997 1997 1997 2000 2000 1997 1997

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

TIMOLOL MALEATE
SOLUTION/DROPS; OPHTHALMIC TIMOLOL MALEATE FALCON PHARMS EQ EQ FDC LTD EQ EQ HI TECH PHARMA EQ PACIFIC PHARMA EQ EQ WOCKHARDT EQ EQ TIMOPTIC + ATON EQ + EQ ISTALOL + ISTA PHARMS EQ TIMOPTIC IN OCUDOSE + ATON EQ + EQ

3 - 397 (of 424)

AT AT AT AT AT AT AT AT AT AT AT BT XX XX

0.25% BASE 0.5% BASE 0.25% BASE 0.5% BASE 0.5% BASE 0.25% BASE 0.5% BASE 0.25% BASE 0.5% BASE 0.25% BASE 0.5% BASE 0.5% BASE 0.25% BASE 0.5% BASE

A074261 A074262 A077259 A077259 A075163 A074746 A074747 A078771 A078771

001 001 001 002 001 001 001 001 002

Apr Apr Apr Apr Sep Mar Mar Sep Sep

28, 28, 30, 30, 10, 25, 25, 28, 28,

1995 1995 2008 2008 2002 1997 1997 2009 2009

N018086 001 N018086 002 N021516 001 N019463 001 N019463 002 Jun 04, 2004 Nov 05, 1986 Nov 05, 1986

TABLET; ORAL TIMOLOL MALEATE MYLAN XX XX XX +

5MG 10MG 20MG

A072668 002 A072668 003 A072668 001

Jun 08, 1990 Jun 08, 1990 Jun 08, 1990

TINIDAZOLE
TABLET; ORAL TINDAMAX MISSION PHARMA XX XX +

250MG 500MG

N021618 001 N021618 002

May 17, 2004 May 17, 2004

TINZAPARIN SODIUM
INJECTABLE; INJECTION

INNOHEP

XX + LEO PHARMA AS

20,000 IU/ML

N020484 001

Jul 14, 2000

TIOPRONIN

TABLET; ORAL

TIOPRONIN
XX + MISSION PHARMA

100MG

N019569 001

Aug 11, 1988

TIOTROPIUM BROMIDE MONOHYDRATE

POWDER; INHALATION

SPIRIVA

XX + BOEHRINGER INGELHEIM

EQ 0.018MG BASE/INH

N021395 001

Jan 30, 2004

TIPRANAVIR
CAPSULE; ORAL

APTIVUS

XX + BOEHRINGER INGELHEIM SOLUTION; ORAL

APTIVUS

XX + BOEHRINGER INGELHEIM

250MG

N021814 001

Jun 22, 2005

100MG/ML

N022292 001

Jun 23, 2008

TIROFIBAN HYDROCHLORIDE
INJECTABLE; INJECTION AGGRASTAT MEDICURE XX

EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)

N020913 002

May 17, 2002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

TIROFIBAN HYDROCHLORIDE
INJECTABLE; INJECTION
AGGRASTAT
XX + MEDICURE

3 - 398 (of 424)

EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)

N020913 003

Apr 20, 2000

TIZANIDINE HYDROCHLORIDE
CAPSULE; ORAL
ZANAFLEX
XX ACORDA
XX XX +

EQ 2MG BASE EQ 4MG BASE EQ 6MG BASE

N021447 001 N021447 002 N021447 003

Aug 29, 2002 Aug 29, 2002 Aug 29, 2002

AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB

TABLET; ORAL TIZANIDINE HYDROCHLORIDE ALPHAPHARM EQ EQ APOTEX EQ EQ CARACO EQ EQ COREPHARMA EQ EQ DR REDDYS LABS INC EQ EQ MYLAN EQ EQ SANDOZ EQ EQ TEVA EQ EQ ZANAFLEX EQ + ACORDA

2MG 4MG 2MG 4MG 2MG 4MG 2MG 4MG 2MG 4MG 2MG 4MG 2MG 4MG 2MG 4MG

BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE

A076282 A076282 A076533 A076533 A076416 A076416 A076347 A076347 A076286 A076286 A076354 A076354 A076399 A076280 A076284 A076284

001 002 001 002 001 002 001 002 001 002 001 002 001 002 001 002

Dec Dec Jan Jan Sep Sep Oct Oct Jul Jul Mar Mar Nov Jun Jul Jul

16, 16, 16, 16, 29, 29, 11, 11, 03, 03, 28, 28, 26, 27, 03, 03,

2003 2003 2004 2004 2003 2003 2002 2002 2002 2002 2003 2003 2002 2002 2002 2002

4MG BASE

N020397 001

Nov 27, 1996

TOBRAMYCIN

OINTMENT; OPHTHALMIC

TOBREX
XX + ALCON
SOLUTION; INHALATION

TOBI
XX + NOVARTIS PHARMS

0.3%

N050555 001

300MG/5ML

N050753 001

Dec 22, 1997

AT AT AT AT AT AT

SOLUTION/DROPS; OPHTHALMIC AKTOB AKORN 0.3% TOBRAMYCIN BAUSCH AND LOMB 0.3% FERA PHARMS 0.3% NOVEX 0.3% TOBREX ALCON 0.3% 0.3% + FALCON PHARMS

A064096 001 A064052 001 A065026 001 A065087 001 A062535 001 N050541 001

Jan 31, 1996 Nov 29, 1993 Sep 11, 2001 Feb 25, 2002 Dec 13, 1984

TOBRAMYCIN SULFATE
INJECTABLE; INJECTION TOBRAMYCIN SULFATE AKORN STRIDES APOTHECON APP PHARMS +

AP AP AP AP AP

EQ EQ EQ EQ EQ

40MG BASE/ML 10MG BASE/ML 10MG BASE/ML 40MG BASE/ML 1.2GM BASE/VIAL

A065407 A064021 A065122 A065122 N050789

001 001 001 002 001

Mar May Nov Nov Jul

11, 31, 29, 29, 13,

2008 1994 2002 2002 2004

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

TOBRAMYCIN SULFATE
INJECTABLE; INJECTION TOBRAMYCIN SULFATE BAXTER HLTHCARE AP EQ 40MG BASE/ML AP + HOSPIRA EQ 10MG BASE/ML AP EQ 40MG BASE/ML AP + EQ 40MG BASE/ML MARSAM PHARMS LLC AP EQ 10MG BASE/ML TEVA PARENTERAL AP EQ 40MG BASE/ML AP + X GEN PHARMS EQ 1.2GM BASE/VIAL TOBRAMYCIN SULFATE (PHARMACY BULK) APP PHARMS AP EQ 40MG BASE/ML TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER EQ 1.2MG BASE/ML XX + HOSPIRA EQ 1.6MG BASE/ML XX + EQ 80MG BASE/100ML XX +

3 - 399 (of 424)

A063117 A063112 A063111 A063116 A062945 A063100 A065013

001 001 001 001 001 001 001

Apr Apr Apr May Aug Jan Aug

26, 30, 30, 18, 09, 30, 17,

1991 1991 1991 1992 1989 1992 2001

A065120 001 A063081 003 A063081 006 A063081 001

Nov 29, 2002 Jul 31, 1990 Jun 02, 1993 Jul 31, 1990

TOLAZAMIDE
TABLET; ORAL TOLAZAMIDE MYLAN AB AB + WATSON LABS AB AB

250MG 500MG 250MG 500MG

A070259 A070259 A070514 A070515

001 003 001 001

Jan Mar Jan Jan

02, 17, 09, 09,

1986 1986 1986 1986

TOLBUTAMIDE
TABLET; ORAL TOLBUTAMIDE MYLAN AB AB + WATSON LABS AB

500MG 500MG 500MG

A086445 001 A086109 001 A087318 001

TOLCAPONE

TABLET; ORAL

TASMAR
XX + VALEANT PHARM INTL

100MG

N020697 001

Jan 29, 1998

TOLMETIN SODIUM
CAPSULE; ORAL TOLMETIN SODIUM MYLAN AB AB + TEVA TABLET; ORAL TOLMETIN SODIUM MUTUAL PHARM AB AB + MYLAN

EQ 400MG BASE EQ 400MG BASE

A073393 001 A073290 001

May 27, 1993 Nov 27, 1991

EQ 200MG BASE EQ 600MG BASE

A073310 001 A074473 001

Nov 27, 1991 Aug 30, 1994

TOLTERODINE TARTRATE
CAPSULE, EXTENDED RELEASE; ORAL DETROL LA XX PHARMACIA AND UPJOHN 2MG XX + 4MG TABLET; ORAL DETROL XX PHARMACIA AND UPJOHN XX +

N021228 001 N021228 002

Dec 22, 2000 Dec 22, 2000

1MG 2MG

N020771 001 N020771 002

Mar 25, 1998 Mar 25, 1998

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

TOLVAPTAN
TABLET; ORAL SAMSCA OTSUKA AMERICA PHARM XX XX +

3 - 400 (of 424)

15MG 30MG

N022275 001 N022275 002

May 19, 2009 May 19, 2009

TOPIRAMATE
CAPSULE; ORAL TOPAMAX JANSSEN PHARMS AB AB + TOPIRAMATE MYLAN AB AB SANDOZ AB AB TEVA AB AB WATSON LABS AB AB ZYDUS PHARMS USA INC AB AB TABLET; ORAL TOPAMAX AB + JANSSEN PHARMS AB AB AB TOPIRAMATE ACCORD HLTHCARE AB AB AB AB APOTEX INC AB AB AB AB AUROBINDO PHARMA AB AB AB AB CIPLA LTD AB AB AB AB GLENMARK GENERICS AB AB AB AB INVAGEN PHARMS AB AB AB AB MYLAN AB AB AB AB RANBAXY AB AB AB

15MG 25MG 15MG 25MG 15MG 25MG 15MG 25MG 15MG 25MG 15MG 25MG

N020844 001 N020844 002 A078418 A078418 A079206 A079206 A076575 A076575 A077868 A077868 A078877 A078877 001 002 001 002 001 002 001 002 001 002

Oct 26, 1998 Oct 26, 1998 Oct Oct Oct Oct Apr Apr Apr Apr Oct Oct 14, 14, 14, 14, 17, 17, 15, 15, 14, 14, 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009

25MG 50MG 100MG 200MG 25MG 50MG 100MG 200MG 25MG 50MG 100MG 200MG 25MG 50MG 100MG 200MG 25MG 50MG 100MG 200MG 25MG 50MG 100MG 200MG 25MG 50MG 100MG 200MG 25MG 50MG 100MG 200MG 25MG 100MG 200MG

N020505 N020505 N020505 N020505 A076311 A076311 A076311 A076311 A077733 A077733 A077733 A077733 A078462 A078462 A078462 A078462 A076343 A076343 A076343 A076343 A077627 A077627 A077627 A077627 A079162 A079162 A079162 A079162 A076314 A076314 A076314 A076314 A076327 A076327 A076327

004 005 001 002 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003

Dec Dec Dec Dec Mar Mar Mar Mar Mar Mar Mar Mar Mar Mar Mar Mar Mar Mar Mar Mar Mar Mar Mar Mar Mar Mar Mar Mar Mar Mar Mar Mar Mar Mar Mar

24, 24, 24, 24, 27, 27, 27, 27, 27, 27, 27, 27, 27, 27, 27, 27, 27, 27, 27, 27, 27, 27, 27, 27, 27, 27, 27, 27, 27, 27, 27, 27, 27, 27, 27,

1996 1996 1996 1996 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

TOPIRAMATE
TABLET; ORAL TOPIRAMATE SUN PHARM INDS LTD AB AB AB AB TEVA AB AB AB AB TORRENT PHARMS AB AB AB AB UNICHEM AB AB AB UPSHER SMITH AB AB AB AB WATSON LABS AB AB AB AB WOCKHARDT USA AB AB AB AB ZYDUS PHARMS USA INC AB AB AB AB

3 - 401 (of 424)

25MG 50MG 100MG 200MG 25MG 50MG 100MG 200MG 25MG 50MG 100MG 200MG 25MG 50MG 100MG 25MG 50MG 100MG 200MG 25MG 50MG 100MG 200MG 25MG 50MG 100MG 200MG 25MG 50MG 100MG 200MG

A090278 A090278 A090278 A090278 A076317 A076317 A076317 A076317 A079153 A079153 A079153 A079153 A090162 A090162 A090162 A078499 A078499 A078499 A078499 A077643 A077643 A077643 A077643 A090353 A090353 A090353 A090353 A078235 A078235 A078235 A078235

001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004

Mar Mar Mar Mar Mar Mar Mar Mar Mar Mar Mar Mar Mar Mar Mar Jan Jan Jan Jan Mar Mar Mar Mar Sep Sep Sep Sep Mar Mar Mar Mar

27, 27, 27, 27, 27, 27, 27, 27, 27, 27, 27, 27, 27, 27, 27, 07, 07, 07, 07, 27, 27, 27, 27, 01, 01, 01, 01, 27, 27, 27, 27,

2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2010 2010 2010 2010 2009 2009 2009 2009 2010 2010 2010 2010 2009 2009 2009 2009

TOPOTECAN HYDROCHLORIDE
CAPSULE; ORAL HYCAMTIN SMITHKLINE BEECHAM XX XX + INJECTABLE; INJECTION HYCAMTIN + GLAXOSMITHKLINE TOPOTECAN HYDROCHLORIDE ACTAVIS TOTOWA APP PHARMS DR REDDYS LABS LTD FRESENIUS KABI ONCOL SAGENT PHARMS THREE RIVERS PHARMS

EQ 0.25MG BASE EQ 1MG BASE

N020981 001 N020981 002

Oct 11, 2007 Oct 11, 2007

AP AP AP AP AP AP AP

EQ 4MG BASE/VIAL EQ EQ EQ EQ EQ EQ 4MG 4MG 4MG 4MG 4MG 4MG BASE/VIAL BASE/VIAL BASE/VIAL BASE/VIAL BASE/VIAL BASE/VIAL

N020671 001 A090620 A091089 A201191 A091376 A091284 A091199 001 001 001 001 001 001

May 28, 1996 Dec Nov Mar Nov Jan Dec 02, 29, 09, 29, 26, 01, 2010 2010 2011 2010 2011 2010

SOLUTION; INTRAVENOUS
TOPOTECAN
XX + HOSPIRA INC

EQ 4MG BASE/4ML (EQ 1MG BASE/ML)

N200582 001

Feb 02, 2011

TOREMIFENE CITRATE
TABLET; ORAL

FARESTON

XX + GTX INC

EQ 60MG BASE

N020497 001

May 29, 1997

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

TORSEMIDE
INJECTABLE; INJECTION TORSEMIDE AP + BEDFORD LABS AP + LUITPOLD AP AP TABLET; ORAL DEMADEX MEDA PHARMS AB AB AB + AB TORSEMIDE APOTEX INC AB AB AB AB AUROBINDO PHARMA AB AB AB AB HETERO DRUGS AB AB AB AB PAR PHARM AB AB AB AB PLIVA PHARM IND AB AB AB AB ROXANE AB AB AB SUN PHARM INDS AB AB AB AB TEVA AB AB AB AB VINTAGE PHARMS AB AB AB AB

3 - 402 (of 424)

20MG/2ML 50MG/5ML 50MG/5ML 20MG/2ML

(10MG/ML) (10MG/ML) (10MG/ML) (10MG/ML)

A078007 A078007 A090656 A090656

001 002 002 001

Jun Jun Apr Apr

11, 11, 21, 21,

2008 2008 2010 2010

5MG 10MG 20MG 100MG 5MG 10MG 20MG 100MG 5MG 10MG 20MG 100MG 5MG 10MG 20MG 100MG 5MG 10MG 20MG 100MG 5MG 10MG 20MG 100MG 5MG 10MG 20MG 5MG 10MG 20MG 100MG 5MG 10MG 20MG 100MG 5MG 10MG 20MG 100MG

N020136 N020136 N020136 N020136 A076894 A076894 A076894 A076894 A078249 A078249 A078249 A078249 A079234 A079234 A079234 A079234 A076226 A076226 A076226 A076226 A076346 A076346 A076346 A076346 A076943 A076943 A076943 A078478 A078478 A078478 A078478 A076110 A076110 A076110 A076110 A090613 A090613 A090613 A090613

001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 001 002 003 004 001 002 003 004 001 002 003 004

Aug Aug Aug Aug May May May May Oct Oct Oct Oct Jan Jan Jan Jan May May May May May May May Oct Mar Mar Mar Feb Feb Feb Feb May May May May Mar Mar Mar Mar

23, 23, 23, 23, 31, 31, 31, 31, 17, 17, 17, 17, 27, 27, 27, 27, 27, 27, 27, 27, 30, 30, 30, 19, 01, 01, 01, 26, 26, 26, 26, 14, 14, 14, 14, 22, 22, 22, 22,

1993 1993 1993 1993 2005 2005 2005 2005 2007 2007 2007 2007 2009 2009 2009 2009 2003 2003 2003 2003 2003 2003 2003 2004 2005 2005 2005 2008 2008 2008 2008 2002 2002 2002 2002 2011 2011 2011 2011

TRAMADOL HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL

CONZIP

100MG XX + CIPHER PHARMS INC 150MG XX 200MG XX 300MG XX TABLET; ORAL TRAMADOL HYDROCHLORIDE ALPHAPHARM AB

N022370 N022370 N022370 N022370

001 004 002 003

May Aug May May

07, 01, 07, 07,

2010 2011 2010 2010

50MG

A075980 001

Nov 21, 2002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

TRAMADOL HYDROCHLORIDE
TABLET; ORAL TRAMADOL HYDROCHLORIDE ALVOGEN AMNEAL PHARMS APOTEX CARACO MALLINCKRODT MUTUAL PHARM MYLAN NORTHSTAR HLTHCARE PLIVA SANDOZ TEVA WATSON LABS ZYDUS PHARMS USA INC ULTRAM + JANSSEN PHARMS

3 - 403 (of 424)

AB AB AB AB AB AB AB AB AB AB AB AB AB AB

50MG 50MG 50MG 50MG 50MG 50MG 50MG 50MG 50MG 50MG 50MG 50MG 50MG 50MG ORAL 100MG 200MG 300MG 100MG 200MG 300MG 100MG 200MG 300MG 100MG 200MG 300MG 100MG 200MG 300MG 100MG 200MG 300MG

A202075 A076003 A075981 A075964 A075983 A076100 A075986 A078935 A075982 A075968 A075977 A075962 A090404

001 001 001 001 001 001 001 001 001 001 001 001 001

Nov Jun Jul Jun Jun Jun Jun May Jul Jun Jun Jun Jan

28, 20, 10, 19, 25, 20, 21, 26, 01, 25, 19, 24, 31,

2011 2002 2002 2002 2002 2002 2002 2010 2002 2002 2002 2002 2011

N020281 002

Mar 03, 1995

TABLET, EXTENDED RELEASE; TRAMADOL HYDROCHLORIDE LUPIN LTD AB1 AB1 AB1 PAR PHARM AB1 AB1 AB1 SUN PHARMA GLOBAL AB1 AB1 AB1 ULTRAM ER AB1 + VALEANT INTL AB1 AB1 RYZOLT AB2 + PURDUE PHARMA AB2 AB2 TRAMADOL HYDROCHLORIDE SUN PHARMA GLOBAL AB2 AB2 AB2

A200503 A200503 A200503 A078783 A078783 A078783 A201384 A201384 A201384

001 002 003 001 002 003 001 002 003

Aug Aug Aug Nov Nov Sep Dec Dec Dec

29, 29, 29, 13, 13, 20, 07, 07, 07,

2011 2011 2011 2009 2009 2011 2011 2011 2011

N021692 001 N021692 002 N021692 003 N021745 001 N021745 002 N021745 003 A091607 001 A091607 002 A091607 003

Sep 08, 2005 Sep 08, 2005 Sep 08, 2005 Dec 30, 2008 Dec 30, 2008 Dec 30, 2008 Dec 30, 2011 Dec 30, 2011 Dec 30, 2011

TABLET, ORALLY DISINTEGRATING; ORAL

TRAMADOL HYDROCHLORIDE

50MG XX + SHIONOGI INC

N021693 001

May 05, 2005

TRANDOLAPRIL
TABLET; ORAL MAVIK ABBOTT AB AB AB + TRANDOLAPRIL AUROBINDO PHARMA AB AB AB CIPLA AB AB AB COREPHARMA AB AB

1MG 2MG 4MG 1MG 2MG 4MG 1MG 2MG 4MG 1MG 2MG

N020528 001 N020528 002 N020528 003 A078438 A078438 A078438 A077307 A077307 A077307 A077256 A077256 001 002 003 002 001 003 001 002

Apr 26, 1996 Apr 26, 1996 Apr 26, 1996 Jun Jun Jun Jun Jun Jun Jun Jun 12, 12, 12, 12, 12, 12, 12, 12, 2007 2007 2007 2007 2007 2007 2007 2007

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

TRANDOLAPRIL
TABLET; ORAL TRANDOLAPRIL COREPHARMA AB DR REDDYS LABS LTD AB AB AB EPIC PHARMA AB AB AB INVAGEN PHARMS AB AB AB LUPIN AB AB AB MYLAN AB AB AB TEVA PHARMS AB AB AB WATSON LABS AB AB AB

3 - 404 (of 424)

4MG 1MG 2MG 4MG 1MG 2MG 4MG 1MG 2MG 4MG 1MG 2MG 4MG 1MG 2MG 4MG 1MG 2MG 4MG 1MG 2MG 4MG

A077256 A078493 A078493 A078493 A078508 A078508 A078508 A078320 A078320 A078320 A077522 A077522 A077522 A078346 A078346 A078346 A077489 A077489 A077489 A077805 A077805 A077805

003 001 002 003 003 001 002 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003

Jun Aug Aug Aug Jun Jun Jun Jun Jun Jun Jun Jun Jun Apr Apr Apr Dec Dec Dec Jun Jun Jun

12, 25, 25, 25, 18, 18, 18, 12, 12, 12, 12, 12, 12, 28, 28, 28, 12, 12, 12, 12, 12, 12,

2007 2008 2008 2008 2008 2008 2008 2007 2007 2007 2007 2007 2007 2008 2008 2008 2006 2006 2006 2007 2007 2007

TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE

TABLET, EXTENDED RELEASE; ORAL TARKA ABBOTT AB 1MG;240MG AB 2MG;180MG AB 2MG;240MG AB + 4MG;240MG TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE GLENMARK GENERICS AB 1MG;240MG AB 2MG;180MG AB 2MG;240MG AB 4MG;240MG

N020591 N020591 N020591 N020591 A079135 A079135 A079135 A079135

003 001 004 002 004 001 002 003

Oct Oct Oct Oct Aug May May May

22, 22, 22, 22, 30, 26, 26, 05,

1996 1996 1996 1996 2010 2010 2010 2010

TRANEXAMIC ACID
INJECTABLE; INJECTION CYKLOKAPRON + PHARMACIA AND UPJOHN TRANEXAMIC ACID MYLAN INSTITUTIONAL PHARMAFORCE VERSAPHARM INC

AP AP AP AP

100MG/ML 100MG/ML 100MG/ML 100MG/ML

N019281 001 A091657 001 A201885 001 A202373 001

Dec 30, 1986 Nov 03, 2011 Aug 10, 2011 Nov 17, 2011

TABLET; ORAL

LYSTEDA

XX + FERRING PHARMS AS

650MG

N022430 001

Nov 13, 2009

TRANYLCYPROMINE SULFATE
TABLET; ORAL PARNATE AB + GLAXOSMITHKLINE EQ 10MG BASE TRANYLCYPROMINE SULFATE PAR PHARM AB EQ 10MG BASE

N012342 003 A040640 001

Aug 16, 1985 Jun 29, 2006

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

TRAVOPROST
SOLUTION/DROPS; OPHTHALMIC

TRAVATAN Z

0.004% XX + ALCON PHARMS LTD

3 - 405 (of 424)

N021994 001

Sep 21, 2006

TRAZODONE HYDROCHLORIDE
TABLET; ORAL TRAZODONE HYDROCHLORIDE ALVOGEN AB 50MG AB 100MG APOTEX AB 50MG AB + APOTEX INC 100MG AB 150MG AB 300MG MATRIX LABS LTD AB 50MG AB 100MG AB 150MG AB 300MG MUTUAL PHARM AB 50MG AB 100MG AB 150MG PLIVA AB 50MG AB 100MG AB 150MG VINTAGE AB 50MG AB 100MG WATSON LABS AB 50MG AB 100MG TABLET, EXTENDED RELEASE; ORAL

OLEPTRO

150MG XX + ANGELINI LLC 300MG XX

A071636 A071514 A071258 A071196 A071196 A071196 A090514 A090514 A090514 A090514 A073137 A073137 A073137 A071523 A071524 A071525 A072192 A072193 A070857 A070858

001 001 001 001 002 003 001 002 003 004 002 001 003 001 001 001 001 001 001 001

Apr Apr Mar Mar Apr Apr Jun Jun Jun Jun Mar Mar Dec Dec Dec Mar Feb Feb Oct Oct

18, 18, 25, 25, 26, 26, 02, 02, 02, 02, 24, 24, 22, 11, 11, 09, 02, 02, 10, 10,

1988 1988 1987 1987 1999 1999 2009 2009 2009 2009 1993 1993 1995 1987 1987 1988 1989 1989 1986 1986

N022411 001 N022411 002

Feb 02, 2010 Feb 02, 2010

TREPROSTINIL SODIUM
INJECTABLE; IV (INFUSION)-SC REMODULIN UNITED THERAP 1MG/ML 2.5MG/ML 5MG/ML + 10MG/ML

XX XX XX XX

N021272 N021272 N021272 N021272

001 002 003 004

May May May May

21, 21, 21, 21,

2002 2002 2002 2002

SOLUTION; INHALATION

TYVASO

XX + UNITED THERAP

EQ 0.6MG BASE/ML

N022387 001

Jul 30, 2009

TRETINOIN
CAPSULE; ORAL

TRETINOIN

XX + BARR CREAM; TOPICAL AVITA MYLAN BERTEK RETIN-A + ORTHO JANSSEN + TRETINOIN TRIAX PHARMS LLC

10MG

A077684 001

Jun 22, 2007

AB AB AB AB AB

0.025% 0.025% 0.1% 0.025% 0.1% 0.05%

N020404 003 N019049 001 N017340 001 A075264 001 A075213 001 N017522 001

Jan 14, 1997 Sep 16, 1988

Dec 24, 1998 Dec 24, 1998

RETIN-A AB1 + ORTHO JANSSEN

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

TRETINOIN
CREAM; TOPICAL TRETINOIN TRIAX PHARMS LLC AB1 RENOVA AB2 + ORTHO JANSSEN TRETINOIN SPEAR PHARMS AB2 RENOVA XX + ORTHO JANSSEN TRETINOIN XX + TRIAX PHARMS LLC GEL; TOPICAL RETIN-A AB + ORTHO JANSSEN AB + TRETINOIN TRIAX PHARMS LLC AB AB AVITA BT MYLAN ATRALIN XX + DOW PHARM SCIENCES RETIN-A MICRO XX + VALEANT INTL XX + SOLUTION; TOPICAL RETIN-A AT + ORTHO JANSSEN TRETINOIN WOCKHARDT AT

3 - 406 (of 424)

0.05% 0.05% 0.05% 0.02% 0.0375%

A075265 001 N019963 001 A076498 001 N021108 001 A090098 001

Dec 24, 1998 Dec 29, 1995 Sep 15, 2005 Aug 31, 2000 Mar 22, 2010

0.01% 0.025% 0.01% 0.025% 0.025% 0.05% 0.04% 0.1%

N017955 001 N017579 002 A075589 001 A075529 001 N020400 001 N022070 001 N020475 002 N020475 001 Jun 11, 2002 Feb 22, 2000 Jan 29, 1998 Jul 26, 2007 May 10, 2002 Feb 07, 1997

0.05% 0.05%

N016921 001 A075260 001 Jan 25, 1999

TRIAMCINOLONE ACETONIDE

AEROSOL, METERED; INHALATION

AZMACORT
0.1MG/INH XX + ABBOTT CREAM; TOPICAL KENALOG AT + APOTHECON AT + TRIACET TEVA AT AT TRIAMCINOLONE ACETONIDE ALTANA AT AT AT + G AND W LABS AT PERRIGO NEW YORK AT AT AT TARO AT AT AT AT VINTAGE AT AT TRIDERM CROWN LABS AT

N018117 001

Apr 23, 1982

0.025% 0.1% 0.025% 0.5% 0.025% 0.1% 0.5% 0.025% 0.025% 0.1% 0.5% 0.025% 0.1% 0.1% 0.5% 0.025% 0.1% 0.1%

N011601 003 N011601 006 A084908 001 A084908 003 A085692 A085692 A085692 A089797 A086415 A086414 A086413 A086277 A040039 A086276 A086275 A040671 A040671 001 003 002 001 001 001 001 001 001 001 001 001 002

May 31, 1991

Nov 26, 1997

Jun 09, 2006 Jun 09, 2006 Mar 19, 1984

A088042 001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

TRIAMCINOLONE ACETONIDE
INJECTABLE; INJECTION KENALOG-10 APOTHECON AB 10MG/ML KENALOG-40 AB + APOTHECON 40MG/ML TRIAMCINOLONE ACETONIDE SANDOZ AB 10MG/ML AB 40MG/ML INJECTABLE; INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL
TRIVARIS
8MG/0.1ML (8MG/0.1ML) XX + ALLERGAN
INJECTABLE; INTRAVITREAL

TRIESENCE
XX + ALCON

3 - 407 (of 424)

N012041 001 N014901 001 A090166 001 A090164 001 May 27, 2009 May 27, 2009

N022220 001

Jun 16, 2008

40MG/ML (40MG/ML)

N022048 001

Nov 29, 2007

LOTION; TOPICAL TRIAMCINOLONE ACETONIDE ALTANA AT 0.025% AT 0.1% MORTON GROVE AT 0.025% TARO AT 0.1% VINTAGE AT 0.1% AT + WOCKHARDT 0.1% OINTMENT; TOPICAL KENALOG APOTHECON AT AT TRIAMCINOLONE ACETONIDE NYCOMED US AT AT AT AT + PERRIGO NEW YORK AT + AT + TARO AT AT AT AT AT TRIAMCINOLONE ACETONIDE XX + CAROLINA MEDCL

A040467 A040467 A088450 A089129 A040672 A088451

001 002 001 001 002 001

Apr Apr Apr Aug Dec Apr

21, 21, 01, 14, 13, 03,

2003 2003 1985 1986 2006 1985

0.025% 0.1% 0.025% 0.1% 0.5% 0.025% 0.1% 0.5% 0.025% 0.025% 0.1% 0.1% 0.5% IN ABSORBASE 0.05%

N011600 003 N011600 001 A085691 A085691 A085691 A087356 A087357 A087385 A040040 A040374 A040037 A087902 A040386 001 003 002 001 001 001 001 001 001 001 001

Sep Jun Sep Dec Jun

30, 05, 30, 27, 05,

1994 2001 1994 1982 2001

A089595 001

Mar 23, 1995

PASTE; DENTAL TRIAMCINOLONE ACETONIDE LYNE AT 0.1% AT + TARO 0.1%

SPRAY; TOPICAL

KENALOG
XX + RANBAXY

A040771 001 A070730 001

Jul 01, 2010 Oct 01, 1986

0.147MG/GM

N012104 001

SPRAY, METERED; NASAL NASACORT AQ AB + SANOFI AVENTIS US 0.055MG/SPRAY TRIAMCINOLONE ACETONIDE TEVA BRANDED PHARM AB 0.055MG/SPRAY

N020468 001 A078104 001

May 20, 1996 Jul 30, 2009

TRIAMCINOLONE HEXACETONIDE

INJECTABLE; INJECTION

ARISTOSPAN
XX + SANDOZ XX +

5MG/ML 20MG/ML

N016466 001 N016466 002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

TRIAMTERENE
CAPSULE; ORAL
DYRENIUM
WELLSPRING PHARM XX XX +

3 - 408 (of 424)

50MG 100MG

N013174 001
N013174 002

TRIAZOLAM
TABLET; ORAL HALCION PHARMACIA AND UPJOHN AB AB + TRIAZOLAM ALPHAPHARM AB AB ROXANE AB AB WATSON LABS AB AB

0.125MG 0.25MG 0.125MG 0.25MG 0.125MG 0.25MG 0.125MG 0.25MG

N017892 003 N017892 001 A074031 A074031 A074224 A074224 A074445 A074445 001 002 001 002 001 002

Apr 26, 1985 Nov 15, 1982 Mar Mar Jun Jun Oct Oct 25, 25, 01, 01, 20, 20, 1994 1994 1994 1994 1995 1995

TRIENTINE HYDROCHLORIDE
CAPSULE; ORAL
SYPRINE
XX + ATON

250MG

N019194 001

Nov 08, 1985

TRIFLUOPERAZINE HYDROCHLORIDE
TABLET; ORAL TRIFLUOPERAZINE HYDROCHLORIDE MYLAN AB EQ 1MG BASE AB EQ 2MG BASE AB EQ 5MG BASE AB + EQ 10MG BASE SANDOZ AB EQ 1MG BASE AB EQ 2MG BASE AB EQ 5MG BASE AB EQ 10MG BASE

A040209 A040209 A040209 A040209 A085785 A085786 A085789 A085788

001 002 003 004 001 001 001 001

Jul Jul Jul Jul

07, 07, 07, 07,

1997 1997 1997 1997

TRIFLURIDINE
SOLUTION/DROPS; OPHTHALMIC TRIFLURIDINE ALCON AT 1% VIROPTIC AT + MONARCH PHARMS 1%

A074311 001 N018299 001

Oct 06, 1995

TRIHEXYPHENIDYL HYDROCHLORIDE
ELIXIR; ORAL TRIHEXYPHENIDYL HYDROCHLORIDE MIKART AA 2MG/5ML AA + PHARM ASSOC 2MG/5ML TABLET; ORAL TRIHEXYPHENIDYL HYDROCHLORIDE NATCO PHARMA LTD 2MG 5MG VINTAGE PHARMS 2MG 5MG WATSON LABS 2MG + 2MG 5MG + 5MG WEST WARD 2MG

A040251 001 A040177 001

Sep 27, 1999 Apr 17, 1997

AA AA AA AA AA AA AA AA AA

A091630 A091630 A040254 A040254 A040184 A084363 A040184 A084364 A040337

001 002 001 002 001 001 002 001 002

Nov Nov Dec Dec Feb

17, 17, 24, 24, 06,

2010 2010 1998 1998 1998

Feb 06, 1998 Feb 16, 2000

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

TRIHEXYPHENIDYL HYDROCHLORIDE
TABLET; ORAL TRIHEXYPHENIDYL HYDROCHLORIDE WEST WARD AA 5MG

3 - 409 (of 424)

A040337 001

Feb 16, 2000

TRIMETHADIONE
TABLET; ORAL
TRIDIONE
XX + ABBOTT

150MG

N005856 009

TRIMETHOBENZAMIDE HYDROCHLORIDE
CAPSULE; ORAL TIGAN AB + KING PHARMS 300MG TRIMETHOBENZAMIDE HYDROCHLORIDE GAVIS PHARMS AB 300MG MUTUAL PHARMA AB 300MG INJECTABLE; INJECTION TIGAN + JHP PHARMS 100MG/ML TRIMETHOBENZAMIDE HYDROCHLORIDE HOSPIRA 100MG/ML LUITPOLD 100MG/ML TRIMETHOBENZAMIDE HYDROCHLORIDE PRESERVATIVE FREE LUITPOLD 100MG/ML

N017531 006 A076546 001 A076570 001

Dec 13, 2001 Aug 20, 2003 Aug 28, 2003

AP AP AP AP

N017530 001 A088804 001 A091330 001 A091329 001 Apr 03, 1987 Mar 08, 2011 Mar 08, 2011

TRIMETHOPRIM
TABLET; ORAL TRIMETHOPRIM NOVEL LABS INC TEVA WATSON LABS TRIMETHOPRIM + TEVA

AB AB AB XX

100MG 100MG 100MG 200MG

A091437 001 N018679 001 A070049 001 A071259 001

Jun 15, 2011 Jul 30, 1982 Jun 06, 1985 Jun 18, 1987

TRIMETHOPRIM HYDROCHLORIDE
SOLUTION; ORAL
PRIMSOL
XX + FSC

EQ 50MG BASE/5ML

N074973 001

Jan 24, 2000

TRIMIPRAMINE MALEATE
CAPSULE; ORAL SURMONTIL ODYSSEY PHARMS AB AB AB + TRIMIPRAMINE MALEATE MIKAH PHARMA AB AB AB

EQ 25MG BASE EQ 50MG BASE EQ 100MG BASE EQ 25MG BASE EQ 50MG BASE EQ 100MG BASE

N016792 001 N016792 002 N016792 003 A077361 001 A077361 002 A077361 003

Sep 15, 1982 Aug 02, 2006 Aug 02, 2006 Aug 02, 2006

TRIPTORELIN PAMOATE
INJECTABLE; INTRAMUSCULAR TRELSTAR EQ 3.75MG BASE/VIAL XX + WATSON LABS EQ 11.25MG BASE/VIAL XX + EQ 22.5MG BASE/VIAL XX +

N020715 001 N021288 001 N022437 001

Jun 15, 2000 Jun 29, 2001 Mar 10, 2010

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

TROMETHAMINE

INJECTABLE; INJECTION

THAM
XX + HOSPIRA

3 - 410 (of 424)

3.6GM/100ML

N013025 002

TROPICAMIDE
SOLUTION/DROPS; OPHTHALMIC MYDRIACYL AT + ALCON 0.5% AT + 1% TROPICACYL AKORN AT 0.5% AT 1% TROPICAMIDE BAUSCH AND LOMB AT 0.5% AT 1%

A084305 001 A084306 001 A040314 001 A040315 001 A040067 001 A040064 001 Sep 29, 2000 Sep 29, 2000 Jul 27, 1994 Jul 27, 1994

TROSPIUM CHLORIDE

CAPSULE, EXTENDED RELEASE; ORAL

SANCTURA XR
XX + ALLERGAN 60MG TABLET; ORAL SANCTURA + ALLERGAN TROSPIUM CHLORIDE APOTEX GLENMARK GENERICS PADDOCK LLC

N022103 001

Aug 03, 2007

AB AB AB AB

20MG 20MG 20MG 20MG

N021595 001 A091513 001 A091575 001 A091573 001

May 28, 2004 Dec 06, 2011 Aug 13, 2010 Nov 17, 2010

TRYPAN BLUE

SOLUTION; OPHTHALMIC

MEMBRANEBLUE
XX + DORC VISIONBLUE XX + DORC

0.15% 0.06%

N022278 001 N021670 001

Feb 20, 2009 Dec 16, 2004

ULIPRISTAL ACETATE

TABLET; ORAL

ELLA
XX + LAB HRA PHARMA

30MG

N022474 001

Aug 13, 2010

UREA C-13

FOR SOLUTION; ORAL

BREATHTEK UBT FOR H-PYLORI
XX + OTSUKA AMERICA EQ 75MG /POUCH

N020586 002

May 10, 2001

UREA, C-14

CAPSULE; ORAL

PYTEST
XX + AVENT PYTEST KIT XX + AVENT

1uCi 1uCi

N020617 001 N020617 002

May 09, 1997 May 09, 1997

UROFOLLITROPIN

INJECTABLE; INTRAMUSCULAR, SUBCUTANEOUS

BRAVELLE
75 IU/VIAL XX + FERRING

N021289 001

May 06, 2002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

URSODIOL
CAPSULE; ORAL ACTIGALL + WATSON PHARMS URSODIOL COREPHARMA EPIC PHARMA LANNETT MYLAN TEVA PHARMS

3 - 411 (of 424)

AB AB AB AB AB AB

300MG 300MG 300MG 300MG 300MG 300MG

N019594 002 A077895 A075517 A079082 A090530 A075592 001 001 001 001 001

Dec 31, 1987 Jul Mar Dec Feb May 27, 14, 15, 17, 25, 2006 2000 2008 2010 2000

TABLET; ORAL URSO 250 APTALIS PHARMA US AB URSO FORTE AB + APTALIS PHARMA US URSODIOL GLENMARK GENERICS AB AB TEVA PHARMS AB AB WATSON LABS INC AB AB

250MG 500MG 250MG 500MG 250MG 500MG 250MG 500MG

N020675 001 N020675 002 A090801 A090801 A079184 A079184 A200826 A200826 001 002 001 002 001 002

Dec 10, 1997 Jul 21, 2004 Jul Jul May May Dec Dec 12, 12, 13, 13, 23, 23, 2011 2011 2009 2009 2011 2011

VALACYCLOVIR HYDROCHLORIDE
TABLET; ORAL VALACYCLOVIR HYDROCHLORIDE ACTAVIS PHARMA EQ EQ AUROBINDO PHARMA EQ EQ DR REDDYS LABS LTD EQ EQ MATRIX LABS LTD EQ EQ MYLAN EQ EQ RANBAXY EQ EQ ROXANE EQ EQ SANDOZ EQ EQ TEVA PHARMS EQ EQ WATSON LABS EQ EQ WOCKHARDT EQ EQ VALTREX GLAXOSMITHKLINE EQ + EQ

AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB

500MG BASE 1GM BASE 500MG BASE 1GM BASE 500MG BASE 1GM BASE 500MG BASE 1GM BASE 500MG BASE 1GM BASE 500MG BASE 1GM BASE 500MG BASE 1GM BASE 500MG BASE 1GM BASE 500MG BASE 1GM BASE 500MG BASE 1GM BASE 500MG BASE 1GM BASE 500MG BASE 1GM BASE

A090370 A090370 A090682 A090682 A079012 A079012 A078518 A078518 A078070 A078070 A076588 A076588 A078656 A078656 A077478 A077478 A077655 A077655 A077135 A077135 A090216 A090216

001 002 001 002 001 002 001 002 001 002 001 002 001 002 001 002 001 002 001 002 001 002

Mar Mar May May May May May May May May Jan Jan May May May May May May May May May May

16, 16, 24, 24, 24, 24, 24, 24, 24, 24, 31, 31, 24, 24, 24, 24, 24, 24, 24, 24, 24, 24,

2011 2011 2010 2010 2010 2010 2010 2010 2010 2010 2007 2007 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010

N020487 001 N020487 002

Jun 23, 1995 Jun 23, 1995

VALGANCICLOVIR HYDROCHLORIDE
FOR SOLUTION; ORAL

VALCYTE

XX + ROCHE PALO TABLET; ORAL

VALCYTE

XX + ROCHE PALO

50MG/ML

N022257 001

Aug 28, 2009

EQ 450MG BASE

N021304 001

Mar 29, 2001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

VALPROATE SODIUM
INJECTABLE; INJECTION DEPACON + ABBOTT VALPROATE SODIUM APP PHARMS BEDFORD HIKMA FARMACEUTICA

3 - 412 (of 424)

AP AP AP AP

EQ 100MG BASE/ML EQ 100MG BASE/ML EQ 100MG BASE/ML EQ 100MG BASE/ML

N020593 001 A076539 001 A076295 001 A078523 001

Dec 30, 1996 Jun 26, 2003 Nov 14, 2002 Feb 17, 2010

VALPROIC ACID
CAPSULE; ORAL DEPAKENE AB + ABBOTT VALPROIC ACID BANNER PHARMACAPS AB CATALENT AB

250MG 250MG 250MG

N018081 001 A073484 001 A073229 001 Jun 29, 1993 Oct 29, 1991

CAPSULE, DELAYED RELEASE; ORAL STAVZOR BANNER PHARMACAPS 125MG XX 250MG XX 500MG XX + SYRUP; ORAL DEPAKENE + ABBOTT VALPROIC ACID ALPHARMA HIGH TECH PHARMA PHARM ASSOC SUN PHARM INDS INC TEVA PHARMS VINTAGE WOCKHARDT

N022152 001 N022152 002 N022152 003

Jul 29, 2008 Jul 29, 2008 Jul 29, 2008

AA AA AA AA AA AA AA AA

250MG/5ML 250MG/5ML 250MG/5ML 250MG/5ML 250MG/5ML 250MG/5ML 250MG/5ML 250MG/5ML

N018082 001 A075782 A074060 A075379 A090517 A073178 A077960 A070868 001 001 001 001 001 001 001 Dec Jan Dec May Aug Oct Jul 22, 13, 15, 28, 25, 13, 01, 2000 1995 2000 2010 1992 2006 1986

VALRUBICIN
SOLUTION; INTRAVESICAL
VALSTAR PRESERVATIVE FREE
40MG/ML XX + ENDO PHARM

N020892 001

Sep 25, 1998

VALSARTAN
TABLET; ORAL DIOVAN NOVARTIS XX XX XX XX +

40MG 80MG 160MG 320MG

N021283 N021283 N021283 N021283

004 001 002 003

Aug Jul Jul Jul

14, 18, 18, 18,

2002 2001 2001 2001

VANCOMYCIN HYDROCHLORIDE
CAPSULE; ORAL VANCOCIN HYDROCHLORIDE VIROPHARMA XX XX +

EQ 125MG BASE EQ 250MG BASE

N050606 001 N050606 002

Apr 15, 1986 Apr 15, 1986

AP AP AP AP AP AP

INJECTABLE; INJECTION VANCOMYCIN HYDROCHLORIDE + APP PHARMS EQ + EQ + EQ + EQ BIONICHE PHARMA USA EQ EQ

500MG BASE/VIAL 1GM BASE/VIAL 5GM BASE/VIAL 10GM BASE/VIAL 500MG BASE/VIAL 1GM BASE/VIAL

A062663 A062663 A062663 A062663 A065401 A065401

001 002 003 004 001 002

Mar Jul Jun Nov Jun Jun

17, 31, 03, 28, 30, 30,

1987 1987 1988 1997 2008 2008

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

VANCOMYCIN HYDROCHLORIDE
INJECTABLE; INJECTION VANCOMYCIN HYDROCHLORIDE + HOSPIRA EQ 500MG BASE/VIAL + EQ 500MG BASE/VIAL EQ 750MG BASE/VIAL EQ 750MG BASE/VIAL + EQ 1GM BASE/VIAL + EQ 1GM BASE/VIAL + EQ 5GM BASE/VIAL HOSPIRA INC EQ 10GM BASE/VIAL PFIZER EQ 500MG BASE/VIAL EQ 1GM BASE/VIAL EQ 5GM BASE/VIAL EQ 10GM BASE/VIAL SANDOZ EQ 500MG BASE/VIAL EQ 1GM BASE/VIAL STRIDES ARCOLAB LTD EQ 10GM BASE/VIAL VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER + BAXTER HLTHCARE EQ 500MG BASE/100ML + EQ 750MG BASE/150ML

3 - 413 (of 424)

AP AP AP AP AP AP AP AP AP AP AP AP AP AP AP XX XX

A062911 A062931 A062912 A062933 A062912 A062933 A063076 A065455 A065397 A065397 A065432 A091469 A090250 A090250 A091554

001 001 002 002 001 001 001 001 001 002 001 001 001 002 001

Aug Oct Jan May Aug Oct Dec Apr Dec Dec Dec Jul Apr Apr Sep

04, 29, 07, 27, 04, 29, 21, 29, 30, 30, 30, 01, 27, 27, 19,

1988 1992 2009 2009 1988 1992 1990 2009 2008 2008 2008 2011 2010 2010 2011

N050671 001 N050671 002

Apr 29, 1993 Dec 20, 2010

VANDETANIB
TABLET; ORAL VANDETANIB IPR PHARMS INC XX XX +

100MG 300MG

N022405 001 N022405 002

Apr 06, 2011 Apr 06, 2011

VARDENAFIL HYDROCHLORIDE
TABLET; ORAL LEVITRA BAYER HLTHCARE XX XX XX XX +

2.5MG 5MG 10MG 20MG

N021400 N021400 N021400 N021400

003 001 002 004

Aug Aug Aug Aug

19, 19, 19, 19,

2003 2003 2003 2003

TABLET, ORALLY DISINTEGRATING; ORAL

STAXYN

10MG XX + BAYER HLTHCARE

N200179 001

Jun 17, 2010

VARENICLINE TARTRATE
TABLET; ORAL CHANTIX PFIZER INC XX XX +

EQ 0.5MG BASE EQ 1MG BASE

N021928 001 N021928 002

May 10, 2006 May 10, 2006

VECURONIUM BROMIDE
INJECTABLE; INJECTION VECURONIUM BROMIDE AP + BEDFORD AP + HOSPIRA AP AP MUSTAFA NEVZAT AP AP PFIZER AP AP SUN PHARMA GLOBAL AP AP TEVA PARENTERAL AP

10MG/VIAL 20MG/VIAL 10MG/VIAL 20MG/VIAL 10MG/VIAL 20MG/VIAL 10MG/VIAL 20MG/VIAL 10MG/VIAL 20MG/VIAL 10MG/VIAL

A075549 A075549 A075164 A075164 A078274 A078274 A090243 A090243 A079001 A079001 A074688

001 002 001 002 001 002 001 002 001 002 001

Jun Jun Oct Oct Dec Dec May May Jun Jun Aug

13, 13, 21, 21, 29, 29, 11, 11, 17, 17, 25,

2000 2000 1999 1999 2008 2008 2010 2010 2009 2009 1999

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

VECURONIUM BROMIDE
INJECTABLE; INJECTION VECURONIUM BROMIDE TEVA PARENTERAL AP WATSON LABS AP AP

3 - 414 (of 424)

20MG/VIAL 10MG/VIAL 20MG/VIAL

A074688 002 A074334 001 A074334 002

Aug 25, 1999 Aug 31, 1995 Aug 31, 1995

VELAGLUCERASE ALFA
INJECTABLE; IV (INFUSION) VPRIV SHIRE HUMAN GENETIC 400 UNITS/VIAL XX

N022575 001

Feb 26, 2010

VEMURAFENIB

TABLET; ORAL

ZELBORAF
XX + HOFFMANN LA ROCHE

240MG

N202429 001

Aug 17, 2011

VENLAFAXINE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL EFFEXOR XR WYETH PHARMS INC EQ 37.5MG BASE EQ 75MG BASE + EQ 150MG BASE VENLAFAXINE HYDROCHLORIDE AUROBINDO PHARMA LTD EQ 37.5MG BASE EQ 75MG BASE EQ 150MG BASE DR REDDYS LABS LTD EQ 37.5MG BASE EQ 75MG BASE EQ 150MG BASE MYLAN EQ 37.5MG BASE EQ 75MG BASE EQ 150MG BASE ORCHID HLTHCARE EQ 37.5MG BASE EQ 75MG BASE EQ 150MG BASE TEVA EQ 37.5MG BASE EQ 75MG BASE EQ 150MG BASE TORRENT PHARMS LLC EQ 37.5MG BASE EQ 75MG BASE EQ 150MG BASE VALEANT INTL EQ 37.5MG BASE EQ 75MG BASE EQ 150MG BASE WOCKHARDT EQ 37.5MG BASE EQ 75MG BASE EQ 150MG BASE ZYDUS PHARMS USA INC EQ 37.5MG BASE EQ 75MG BASE EQ 150MG BASE TABLET; ORAL VENLAFAXINE HYDROCHLORIDE ACTAVIS TOTOWA EQ EQ EQ EQ EQ ALEMBIC PHARMS LTD EQ EQ

AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB

N020699 001 N020699 002 N020699 004 A200834 A200834 A200834 A078421 A078421 A078421 A078789 A078789 A078789 A091123 A091123 A091123 A076565 A076565 A076565 A090899 A090899 A090899 A090071 A090071 A090071 A078865 A078865 A078865 A090174 A090174 A090174 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003

Oct 20, 1997 Oct 20, 1997 Oct 20, 1997 Apr Apr Apr May May May Jun Jun Jun Jul Jul Jul Jun Jun Jun Jun Jun Jun Apr Apr Apr Apr Apr Apr Apr Apr Apr 14, 14, 14, 06, 06, 06, 01, 01, 01, 11, 11, 11, 28, 28, 28, 01, 01, 01, 15, 15, 15, 14, 14, 14, 14, 14, 14, 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2010 2010 2010 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011

AB AB AB AB AB AB AB

25MG BASE 37.5MG BASE 50MG BASE 75MG BASE 100MG BASE 25MG BASE 37.5MG BASE

A078554 A078554 A078554 A078554 A078554 A078932 A078932

001 002 003 004 005 001 002

Jan Jan Jan Jan Jan Dec Dec

09, 09, 09, 09, 09, 14, 14,

2009 2009 2009 2009 2009 2010 2010

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

VENLAFAXINE HYDROCHLORIDE
TABLET; ORAL VENLAFAXINE HYDROCHLORIDE ALEMBIC PHARMS LTD EQ EQ EQ AMNEAL PHARMS EQ EQ EQ EQ EQ AUROBINDO PHARMA EQ EQ EQ EQ EQ CARACO EQ EQ EQ EQ EQ DR REDDYS LABS LTD EQ EQ EQ EQ EQ MYLAN EQ EQ EQ EQ EQ TEVA EQ EQ + EQ EQ EQ VINTAGE EQ EQ EQ EQ EQ ZYDUS PHARMS USA EQ EQ EQ EQ EQ

3 - 415 (of 424)

AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB

50MG BASE 75MG BASE 100MG BASE 25MG BASE 37.5MG BASE 50MG BASE 75MG BASE 100MG BASE 25MG BASE 37.5MG BASE 50MG BASE 75MG BASE 100MG BASE 25MG BASE 37.5MG BASE 50MG BASE 75MG BASE 100MG BASE 25MG BASE 37.5MG BASE 50MG BASE 75MG BASE 100MG BASE 25MG BASE 37.5MG BASE 50MG BASE 75MG BASE 100MG BASE 25MG BASE 37.5MG BASE 50MG BASE 75MG BASE 100MG BASE 25MG BASE 37.5MG BASE 50MG BASE 75MG BASE 100MG BASE 25MG BASE 37.5MG BASE 50MG BASE 75MG BASE 100MG BASE

A078932 A078932 A078932 A079098 A079098 A079098 A079098 A079098 A090555 A090555 A090555 A090555 A090555 A078627 A078627 A078627 A078627 A078627 A078301 A078301 A078301 A078301 A078301 A077166 A077166 A077166 A077166 A077166 A076690 A076690 A076690 A076690 A076690 A090027 A090027 A090027 A090027 A090027 A077653 A077653 A077653 A077653 A077653

003 004 005 001 002 003 004 005 001 002 003 004 005 001 002 003 004 005 001 002 003 004 005 001 002 003 004 005 001 002 003 004 005 001 002 003 004 005 001 002 003 004 005

Dec Dec Dec May May May May May Apr Apr Apr Apr Apr Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Aug Aug Aug Aug Aug Aug Aug Aug Aug Aug Jun Jun Jun Jun Jun

14, 14, 14, 11, 11, 11, 11, 11, 07, 07, 07, 07, 07, 13, 13, 13, 13, 13, 13, 13, 13, 13, 13, 13, 13, 13, 13, 13, 03, 03, 03, 03, 03, 04, 04, 04, 04, 04, 13, 13, 13, 13, 13,

2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2010 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2006 2006 2006 2006 2006 2010 2010 2010 2010 2010 2008 2008 2008 2008 2008

AB AB AB AB AB AB XX

TABLET, EXTENDED RELEASE; ORAL VENLAFAXINE HYDROCHLORIDE OSMOTICA PHARM EQ 37.5MG BASE EQ 75MG BASE + EQ 150MG BASE SUN PHARMA GLOBAL EQ 37.5MG BASE EQ 75MG BASE EQ 150MG BASE VENLAFAXINE HYDROCHLORIDE OSMOTICA PHARM EQ 225MG BASE

N022104 N022104 N022104 A091272 A091272 A091272

001 002 003 001 002 003

May May May Aug Aug Aug

20, 20, 20, 18, 18, 18,

2008 2008 2008 2010 2010 2010

N022104 004

May 20, 2008

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

VERAPAMIL HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL VERAPAMIL HYDROCHLORIDE MYLAN 100MG 120MG 180MG 200MG 240MG 300MG VERELAN ALKERMES GAINESVILLE 120MG 180MG 240MG VERELAN PM ELAN DRUG 100MG 200MG + 300MG VERELAN + ALKERMES GAINESVILLE 360MG

3 - 416 (of 424)

AB AB AB AB AB AB AB AB AB AB AB AB XX

A078306 A075138 A075138 A078306 A075138 A078306

001 001 002 002 003 003

Aug Apr Apr Aug Apr Aug

09, 20, 20, 09, 20, 09,

2007 1999 1999 2007 1999 2007

N019614 001 N019614 003 N019614 002 N020943 001 N020943 002 N020943 003 N019614 004

May 29, 1990 Jan 09, 1992 May 29, 1990 Nov 25, 1998 Nov 25, 1998 Nov 25, 1998 May 10, 1996

INJECTABLE; INJECTION VERAPAMIL HYDROCHLORIDE HOSPIRA AP AP AP INTL MEDICATION AP TABLET; ORAL CALAN GD SEARLE LLC AB AB AB + VERAPAMIL HYDROCHLORIDE MYLAN AB AB WATSON LABS AB AB AB AB AB AB AB AB TABLET, EXTENDED RELEASE; ISOPTIN SR + PFIZER + + VERAPAMIL HYDROCHLORIDE GLENMARK GENERICS

2.5MG/ML 2.5MG/ML 2.5MG/ML 2.5MG/ML

A070737 A070738 A075136 A070451

001 001 001 001

May May Oct Dec

06, 06, 20, 16,

1987 1987 1998 1985

40MG 80MG 120MG 80MG 120MG 40MG 40MG 80MG 80MG 80MG 120MG 120MG 120MG ORAL 120MG 180MG 240MG 120MG 180MG 240MG 120MG 180MG 240MG 120MG 180MG 240MG 120MG 240MG 120MG 180MG

N018817 003 N018817 001 N018817 002 A071482 A071483 A072923 A072924 A070855 A070995 A071366 A070856 A070994 A071367 001 001 001 001 001 001 001 001 001 001

Feb 23, 1988 Sep 10, 1984 Sep 10, 1984 Feb Feb Jun Jun Sep Oct Oct Sep Oct Oct 15, 15, 29, 29, 24, 01, 01, 24, 01, 01, 1989 1989 1993 1993 1986 1986 1986 1986 1986 1986

AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB AB

N019152 003 N019152 002 N019152 001 A090700 A090700 A078906 A073568 A074330 A073568 A074587 A074587 A074587 A075072 A075072 A090529 A090529 001 002 001 002 001 001 002 003 001 001 003 001 002

Mar 06, 1991 Dec 15, 1989 Dec 16, 1986 Aug Aug Sep Oct Jan Jul Feb Sep Mar May May Dec Dec 03, 03, 17, 10, 31, 31, 21, 09, 23, 25, 25, 30, 30, 2011 2011 2009 1997 1994 1992 1997 1997 1996 1999 1999 2011 2011

IVAX SUB TEVA PHARMS

MYLAN

PAR PHARM SUN PHARM INDS INC

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

VERAPAMIL HYDROCHLORIDE
TABLET, EXTENDED RELEASE; VERAPAMIL HYDROCHLORIDE SUN PHARM INDS INC AB COVERA-HS BC + GD SEARLE LLC BC + ORAL 240MG 180MG 240MG

3 - 417 (of 424)

A090529 003 N020552 001 N020552 002

Dec 30, 2011 Feb 26, 1996 Feb 26, 1996

VERTEPORFIN
INJECTABLE; INJECTION

VISUDYNE

XX + QLT

15MG/VIAL

N021119 001

Apr 12, 2000

VIGABATRIN
FOR SOLUTION; ORAL

SABRIL

XX + LUNDBECK INC TABLET; ORAL

SABRIL

XX + LUNDBECK INC

500MG/PACKET

N022006 001

Aug 21, 2009

500MG

N020427 001

Aug 21, 2009

VILAZODONE HYDROCHLORIDE
TABLET; ORAL VIIBRYD FOREST LABS INC XX XX XX +

10MG 20MG 40MG

N022567 001 N022567 002 N022567 003

Jan 21, 2011 Jan 21, 2011 Jan 21, 2011

VINBLASTINE SULFATE
INJECTABLE; INJECTION

VINBLASTINE SULFATE

XX + APP PHARMS XX + BEDFORD

1MG/ML 10MG/VIAL

A089515 001 A089395 001

Apr 29, 1987 Apr 09, 1987

VINCRISTINE SULFATE
INJECTABLE; INJECTION VINCRISTINE SULFATE PFS AP + HOSPIRA 1MG/ML TEVA PARENTERAL AP 1MG/ML

A071484 001 A075493 001

Apr 19, 1988 Sep 01, 1999

VINORELBINE TARTRATE
INJECTABLE; INJECTION NAVELBINE + PIERRE FABRE VINORELBINE TARTRATE ACTAVIS TOTOWA APP PHARMS BAXTER HLTHCARE BEDFORD EBEWE PHARMA HOSPIRA TEVA PARENTERAL

AP AP AP AP AP AP AP AP

EQ 10MG BASE/ML EQ EQ EQ EQ EQ EQ EQ 10MG 10MG 10MG 10MG 10MG 10MG 10MG BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML

N020388 001 A078011 A076849 A075992 A076461 A078408 A076827 A076028 001 001 001 001 001 001 001

Dec 23, 1994 Jul Apr Jun Dec Feb Jun Feb 22, 18, 10, 11, 13, 02, 03, 2009 2005 2003 2003 2008 2005 2003

VITAMIN A PALMITATE
INJECTABLE; INJECTION

AQUASOL A

XX + HOSPIRA

EQ 50,000 UNITS BASE/ML

N006823 001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

VORICONAZOLE
FOR SUSPENSION; ORAL

VFEND

XX + PFIZER

3 - 418 (of 424)

200MG/5ML

N021630 001

Dec 19, 2003

INJECTABLE; IV (INFUSION)
VFEND
XX + PFIZER 200MG/VIAL TABLET; ORAL VFEND PFIZER AB AB + VORICONAZOLE MATRIX LABS LTD AB AB SANDOZ INC AB AB

N021267 001

May 24, 2002

50MG 200MG 50MG 200MG 50MG 200MG

N021266 001 N021266 002 A090547 A090547 A200265 A200265 001 002 001 002

May 24, 2002 May 24, 2002 Apr Apr Dec Dec 22, 22, 12, 12, 2010 2010 2011 2011

VORINOSTAT

CAPSULE; ORAL

ZOLINZA
XX + MERCK

100MG

N021991 001

Oct 06, 2006

WARFARIN SODIUM

INJECTABLE; INJECTION

COUMADIN
XX + BRISTOL MYERS SQUIBB TABLET; ORAL COUMADIN BRISTOL MYERS SQUIBB AB AB AB AB AB AB AB AB AB + JANTOVEN USL PHARMA AB AB AB AB AB AB AB AB AB WARFARIN SODIUM BARR AB AB AB AB AB AB AB AB AB INVAGEN PHARMS AB AB

5MG/VIAL

N009218 024

Feb 07, 1995

1MG 2MG 2.5MG 3MG 4MG 5MG 6MG 7.5MG 10MG 1MG 2MG 2.5MG 3MG 4MG 5MG 6MG 7.5MG 10MG 1MG 2MG 2.5MG 3MG 4MG 5MG 6MG 7.5MG 10MG 1MG 2MG

N009218 N009218 N009218 N009218 N009218 N009218 N009218 N009218 N009218 A040416 A040416 A040416 A040416 A040416 A040416 A040416 A040416 A040416 A040145 A040145 A040145 A040145 A040145 A040145 A040145 A040145 A040145 A090935 A090935

022 013 018 025 023 007 026 016 005 001 002 003 004 005 006 007 008 009 001 002 003 008 004 005 009 006 007 001 002

Mar 01, 1990

Nov 18, 1996 Aug 24, 1993 Nov 18, 1996

Oct Oct Oct Oct Oct Oct Oct Oct Oct Mar Mar Mar Nov Mar Mar Nov Mar Mar May May

02, 02, 02, 02, 02, 02, 02, 02, 02, 26, 26, 26, 05, 26, 26, 05, 26, 26, 25, 25,

2003 2003 2003 2003 2003 2003 2003 2003 2003 1997 1997 1997 1998 1997 1997 1998 1997 1997 2011 2011

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

WARFARIN SODIUM
TABLET; ORAL WARFARIN SODIUM INVAGEN PHARMS AB AB AB AB AB AB AB MYLAN AB AB AB AB AB AB AB AB AB PLIVA AB AB AB AB AB AB AB AB AB TARO AB AB AB AB AB AB AB AB AB ZYDUS PHARMS USA AB AB AB AB AB AB AB AB AB

3 - 419 (of 424)

2.5MG 3MG 4MG 5MG 6MG 7.5MG 10MG 1MG 2MG 2.5MG 3MG 4MG 5MG 6MG 7.5MG 10MG 1MG 2MG 2.5MG 3MG 4MG 5MG 6MG 7.5MG 10MG 1MG 2MG 2.5MG 3MG 4MG 5MG 6MG 7.5MG 10MG 1MG 2MG 2.5MG 3MG 4MG 5MG 6MG 7.5MG 10MG

A090935 A090935 A090935 A090935 A090935 A090935 A090935 A040415 A040415 A040415 A040415 A040415 A040415 A040415 A040415 A040415 A040616 A040616 A040616 A040616 A040616 A040616 A040616 A040616 A040616 A040301 A040301 A040301 A040301 A040301 A040301 A040301 A040301 A040301 A040663 A040663 A040663 A040663 A040663 A040663 A040663 A040663 A040663

003 004 005 006 007 008 009 001 002 003 004 005 006 007 008 009 009 001 002 003 004 005 006 007 008 002 003 004 005 006 007 008 009 001 001 002 003 004 005 006 007 008 009

May May May May May May May Sep Sep Sep Sep Sep Sep Sep Sep Sep Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul May May May May May May May May May

25, 25, 25, 25, 25, 25, 25, 27, 27, 29, 27, 27, 27, 27, 27, 27, 05, 05, 05, 05, 05, 05, 05, 05, 05, 15, 15, 15, 15, 15, 15, 15, 15, 15, 30, 30, 30, 30, 30, 30, 30, 30, 30,

2011 2011 2011 2011 2011 2011 2011 2004 2004 2004 2004 2004 2004 2004 2004 2004 2006 2006 2006 2006 2006 2006 2006 2006 2006 1999 1999 1999 1999 1999 1999 1999 1999 1999 2006 2006 2006 2006 2006 2006 2006 2006 2006

XENON XE-133
GAS; INHALATION XENON XE 133 LANTHEUS MEDCL AA XENON XE 133 XX LANTHEUS MEDCL

20mCi/VIAL 10mCi/VIAL

N017284 002 N017284 001

ZAFIRLUKAST
TABLET; ORAL ACCOLATE ASTRAZENECA AB AB +

10MG 20MG

N020547 003 N020547 001

Sep 17, 1999 Sep 26, 1996

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

ZAFIRLUKAST
TABLET; ORAL ZAFIRLUKAST DR REDDYS LABS LTD AB AB

3 - 420 (of 424)

10MG 20MG

A090372 001 A090372 002

Nov 18, 2010 Nov 18, 2010

ZALEPLON
CAPSULE; ORAL SONATA KING PHARMS AB AB + ZALEPLON AUROBINDO PHARMA AB AB CIPLA LTD AB AB MYLAN AB AB ORCHID HLTHCARE AB AB ROXANE AB AB TEVA PHARMS AB AB UNICHEM AB AB UPSHER SMITH AB AB WEST WARD AB AB

5MG 10MG 5MG 10MG 5MG 10MG 5MG 10MG 5MG 10MG 5MG 10MG 5MG 10MG 5MG 10MG 5MG 10MG 5MG 10MG

N020859 001 N020859 002 A078829 A078829 A077505 A077505 A077238 A077238 A090374 A090374 A077237 A077237 A077239 A077239 A078989 A078989 A078706 A078706 A078147 A078147 001 002 001 002 001 002 001 002 001 002 001 002 001 002 001 002 001 002

Aug 13, 1999 Aug 13, 1999 Jun Jun Jun Jun Jun Jun Sep Sep Jun Jun Jun Jun Jun Jun Jun Jun Nov Nov 06, 06, 20, 20, 06, 06, 17, 17, 06, 06, 06, 06, 06, 06, 06, 06, 25, 25, 2008 2008 2008 2008 2008 2008 2009 2009 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008

ZANAMIVIR
POWDER; INHALATION

RELENZA

XX + GLAXOSMITHKLINE

5MG

N021036 001

Jul 26, 1999

ZICONOTIDE ACETATE

INJECTABLE; INTRATHECAL

PRIALT
XX + AZUR PHARMA II XX + XX +

100MCG/1ML (100MCG/ML) 500MCG/20ML (25MCG/ML) 500MCG/5ML (100MCG/ML)

N021060 002 N021060 001 N021060 004

Dec 28, 2004 Dec 28, 2004 Dec 28, 2004

ZIDOVUDINE
CAPSULE; ORAL RETROVIR AB + VIIV HLTHCARE ZIDOVUDINE AUROBINDO PHARMA LTD AB CIPLA LTD AB INJECTABLE; INJECTION RETROVIR AP + VIIV HLTHCARE ZIDOVUDINE LUITPOLD AP SYRUP; ORAL RETROVIR AA + VIIV HLTHCARE

100MG 100MG 100MG

N019655 001 A078128 001 A078349 001

Mar 19, 1987 Mar 27, 2006 May 23, 2007

10MG/ML 10MG/ML

N019951 001 A091457 001

Feb 02, 1990 May 06, 2010

50MG/5ML

N019910 001

Sep 28, 1989

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

ZIDOVUDINE
SYRUP; ORAL ZIDOVUDINE AUROBINDO AA CIPLA LTD AA TABLET; ORAL RETROVIR + VIIV HLTHCARE ZIDOVUDINE AUROBINDO CIPLA HEC PHARM INC HETERO DRUGS LTD MATRIX LABS LTD RANBAXY ROXANE

3 - 421 (of 424)

50MG/5ML 50MG/5ML

A077268 001 A077981 001

Sep 19, 2005 Jun 26, 2008

AB AB AB AB AB AB AB AB

300MG 300MG 300MG 300MG 300MG 300MG 300MG 300MG

N020518 002 A077267 A090561 A202058 A090092 A078922 A077327 A076844 001 001 001 001 001 001 001

Oct 04, 1996 Sep Oct Oct Apr Feb Sep Sep 19, 27, 07, 25, 14, 19, 19, 2005 2010 2011 2008 2008 2005 2005

ZILEUTON

TABLET; ORAL

ZYFLO
XX + CORNERSTONE THERAP

600MG

N020471 003

Dec 09, 1996

TABLET, EXTENDED RELEASE; ORAL

ZYFLO CR
600MG XX + CORNERSTONE THERAP

N022052 001

May 30, 2007

ZINC ACETATE
CAPSULE; ORAL GALZIN TEVA XX XX +

EQ 25MG ZINC EQ 50MG ZINC

N020458 001 N020458 002

Jan 28, 1997 Jan 28, 1997

ZINC CHLORIDE

INJECTABLE; INJECTION

ZINC CHLORIDE IN PLASTIC CONTAINER
XX + HOSPIRA EQ 1MG ZINC/ML

N018959 001

Jun 26, 1986

ZIPRASIDONE HYDROCHLORIDE

CAPSULE; ORAL

GEODON
XX + PFIZER XX XX XX
SUSPENSION; ORAL

GEODON
XX + PFIZER INC

EQ EQ EQ EQ

20MG 40MG 60MG 80MG

BASE BASE BASE BASE

N020825 N020825 N020825 N020825

001 002 003 004

Feb Feb Feb Feb

05, 05, 05, 05,

2001 2001 2001 2001

EQ 10MG BASE/ML

N021483 001

Mar 29, 2006

ZIPRASIDONE MESYLATE

INJECTABLE; INTRAMUSCULAR

GEODON
EQ 20MG BASE/ML XX + PFIZER

N020919 001

Jun 21, 2002

ZOLEDRONIC ACID
INJECTABLE; IV (INFUSION)
RECLAST
XX + NOVARTIS EQ 5MG BASE/100ML ZOMETA XX + NOVARTIS EQ 4MG BASE/5ML XX + EQ 4MG BASE/100ML

N021817 001 N021223 002 N021223 003

Apr 16, 2007 Mar 07, 2003 Jun 17, 2011

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

ZOLMITRIPTAN

SPRAY; NASAL

ZOMIG
XX + ASTRAZENECA TABLET; ORAL ZOMIG IPR XX XX +

3 - 422 (of 424)

5MG/SPRAY

N021450 004

Sep 30, 2003

2.5MG 5MG

N020768 001 N020768 002

Nov 25, 1997 Nov 25, 1997

TABLET, ORALLY DISINTEGRATING; ORAL ZOMIG-ZMT XX ASTRAZENECA 2.5MG XX + 5MG

N021231 001 N021231 002

Feb 13, 2001 Sep 17, 2001

ZOLPIDEM TARTRATE

SPRAY, METERED; ORAL

ZOLPIMIST
XX + NOVADEL TABLET; ORAL AMBIEN SANOFI AVENTIS US AB AB + ZOLPIDEM TARTRATE APOTEX INC AB AB AUROBINDO PHARMA AB AB CARACO AB AB CARLSBAD AB AB DR REDDYS LABS LTD AB AB HIKMA AB AB INVAGEN PHARMS AB AB LEK PHARMS DD AB AB MYLAN AB AB AB AB RANBAXY AB AB ROXANE AB AB TEVA AB AB TORRENT PHARMS AB AB VINTAGE AB AB WATSON LABS AB AB WOCKHARDT AB AB TABLET; SUBLINGUAL EDLUAR MEDA PHARMS XX

5MG/SPRAY

N022196 001

Dec 19, 2008

5MG 10MG 5MG 10MG 5MG 10MG 5MG 10MG 5MG 10MG 5MG 10MG 5MG 10MG 5MG 10MG 5MG 10MG 5MG 5MG 10MG 10MG 5MG 10MG 5MG 10MG 5MG 10MG 5MG 10MG 5MG 10MG 5MG 10MG 5MG 10MG

N019908 001 N019908 002 A077884 A077884 A078413 A078413 A077359 A077359 A077990 A077990 A077985 A077985 A078129 A078129 A078184 A078184 A077322 A077322 A076578 A078016 A076578 A078016 A078055 A078055 A077214 A077214 A076410 A076410 A077903 A077903 A078616 A078616 A077773 A077773 A078426 A078426 001 002 001 002 001 002 001 002 001 002 001 002 001 002 001 002 001 001 002 002 001 002 001 002 001 002 001 002 001 002 001 002 001 002

Dec 16, 1992 Dec 16, 1992 Apr Apr May May Apr Apr Apr Apr Apr Apr Apr Apr Sep Sep Apr Apr Apr Apr Apr Apr Apr Apr Apr Apr Apr Apr Aug Aug Nov Nov Apr Apr May May 23, 23, 04, 04, 23, 23, 23, 23, 23, 23, 30, 30, 07, 07, 23, 23, 23, 23, 23, 23, 23, 23, 23, 23, 23, 23, 17, 17, 21, 21, 23, 23, 15, 15, 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2008 2008 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2008 2008 2007 2007 2007 2007

5MG

N021997 001

Mar 13, 2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

ZOLPIDEM TARTRATE
TABLET; SUBLINGUAL

EDLUAR

XX + MEDA PHARMS INTERMEZZO PURDUE PHARMA XX XX + TABLET, EXTENDED RELEASE; AMBIEN CR SANOFI AVENTIS US + ZOLPIDEM TARTRATE ACTAVIS S ATLANTIC ANCHEN PHARMS SANDOZ SYNTHON PHARMS ZOLPIDEM TATRATE ACTAVIS S ATLANTIC

3 - 423 (of 424)

10MG 1.75MG 3.5MG ORAL 6.25MG 12.5MG 6.25MG 6.25MG 12.5MG 6.25MG 12.5MG 6.25MG 12.5MG 12.5MG

N021997 002 N022328 001 N022328 002

Mar 13, 2009 Nov 23, 2011 Nov 23, 2011

AB AB AB AB AB AB AB AB AB AB

N021774 002 N021774 001 A078179 A078148 A078148 A090107 A090107 A078483 A078483 002 002 001 001 002 001 002

Sep 02, 2005 Sep 02, 2005 Oct Apr Dec Jul Jul Apr Jun 13, 14, 03, 01, 01, 12, 06, 2010 2011 2010 2011 2011 2011 2011

A078179 001

Jun 06, 2011

ZONISAMIDE
CAPSULE; ORAL ZONEGRAN EISAI INC AB AB AB + ZONISAMIDE ALPHAPHARM AB AB AB APOTEX INC AB AB AB BANNER PHARMACAPS AB AB AB BARR AB AB AB COREPHARMA AB AB AB DR REDDYS LABS LTD AB AB AB GLENMARK GENERICS AB AB AB INVAGEN PHARMS AB AB AB MYLAN AB AB AB SANDOZ AB AB AB SUN PHARM INDS (IN) AB

25MG 50MG 100MG 25MG 50MG 100MG 25MG 50MG 100MG 25MG 50MG 100MG 25MG 50MG 100MG 25MG 50MG 100MG 25MG 50MG 100MG 25MG 50MG 100MG 25MG 50MG 100MG 25MG 50MG 100MG 25MG 50MG 100MG 25MG

N020789 003 N020789 002 N020789 001 A077647 A077647 A077647 A077642 A077642 A077642 A077813 A077813 A077813 A077639 A077639 A077639 A077876 A077876 A077876 A077645 A077645 A077645 A077651 A077651 A077651 A077869 A077869 A077869 A077637 A077637 A077637 A077644 A077644 A077644 A077634 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 002 003 001 001 002 003 001 002 003 001 002 003 001 002 003 001

Aug 22, 2003 Aug 22, 2003 Mar 27, 2000 Dec Dec Dec Dec Dec Dec Aug Aug Aug Dec Dec Dec Feb Feb Feb Sep Sep Dec Jan Jan Jan May May May Dec Dec Dec Dec Dec Dec Mar 22, 22, 22, 22, 22, 22, 16, 16, 16, 22, 22, 22, 21, 21, 21, 29, 29, 22, 30, 30, 30, 31, 31, 31, 22, 22, 22, 22, 22, 22, 17, 2005 2005 2005 2005 2005 2005 2006 2006 2006 2005 2005 2005 2007 2007 2007 2006 2006 2005 2006 2006 2006 2006 2006 2006 2005 2005 2005 2005 2005 2005 2006

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

ZONISAMIDE
CAPSULE; ORAL ZONISAMIDE SUN PHARM INDS (IN) AB AB WOCKHARDT AB AB AB ZYDUS PHARMS USA AB AB AB

3 - 424 (of 424)

50MG 100MG 25MG 50MG 100MG 25MG 50MG 100MG

A077634 A077634 A077636 A077636 A077636 A077625 A077625 A077625

002 003 003 002 001 001 002 003

Mar Mar Jul Jul Dec Oct Oct Oct

17, 17, 27, 27, 22, 16, 16, 16,

2006 2006 2006 2006 2005 2006 2006 2006

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

OTC DRUG PRODUCT LIST

ACETAMINOPHEN
SUPPOSITORY; RECTAL ACEPHEN G AND W LABS

4 - 1 (of 19)

120MG 325MG 325MG 650MG 650MG 120MG 325MG 650MG 120MG 650MG 80MG 120MG ORAL 650MG 650MG 650MG 650MG 650MG

N018060 A072344 N018060 A072237 N018060 N018337 N018337 N018337 A070607 A070608 N018337 N016401

001 001 003 001 002 003 002 001 001 001 004 001

Mar 27, 1992 Dec 18, 1986 Mar 27, 1992

ACETAMINOPHEN ACTAVIS MID ATLANTIC + PERRIGO NEW YORK INFANTS' FEVERALL ACTAVIS MID ATLANTIC NEOPAP POLYMEDICA TABLET, EXTENDED RELEASE; ACETAMINOPHEN OHM LABS PERRIGO RANBAXY LABS LTD TYLENOL (CAPLET) + MCNEIL CONS TYLENOL (GELTAB) + MCNEIL CONS

Sep 12, 1983

Apr 06, 1987 Dec 01, 1986 Aug 26, 1992

A076200 A075077 A078569 N019872 N019872

001 001 001 001 002

Mar 19, 2002 Feb 25, 2000 Dec 14, 2011 Jun 08, 1994 Jan 11, 2001

ACETAMINOPHEN; ASPIRIN; CAFFEINE

TABLET; ORAL ACETAMINOPHEN, ASPIRIN AND CAFFEINE PERRIGO 250MG;250MG;65MG EXCEDRIN (MIGRAINE) + NOVARTIS 250MG;250MG;65MG

A075794 N020802

001 001

Nov 26, 2001 Jan 14, 1998

ACETAMINOPHEN; CLEMASTINE FUMARATE; PSEUDOEPHEDRINE HYDROCHLORIDE

TABLET; ORAL

TAVIST ALLERGY/SINUS/HEADACHE

+ NOVARTIS 500MG;EQ 0.25MG BASE;30MG

N021082

001

Mar 01, 2001

ACETAMINOPHEN; DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE

TABLET, EXTENDED RELEASE; ORAL

DRIXORAL PLUS

+ SCHERING PLOUGH 500MG;3MG;60MG

N019453

001

May 22, 1987

ALCOHOL; CHLORHEXIDINE GLUCONATE

SOLUTION; TOPICAL

AVAGARD

+ 3M

61%;1%

N021074

001

Jun 07, 2001

ALUMINUM HYDROXIDE; MAGNESIUM TRISILICATE

TABLET, CHEWABLE; ORAL FOAMCOAT GUARDIAN DRUG GAVISCON SANOFI AVENTIS US +

80MG;20MG 80MG;20MG 160MG;40MG

A071793 N018685 N018685

001 001 002

Sep 04, 1987 Dec 09, 1983 Dec 09, 1983

AVOBENZONE; ECAMSULE; OCTOCRYLENE

CREAM; TOPICAL

ANTHELIOS SX

+ LOREAL USA CAPITAL SOLEIL 15 + LOREAL USA

2%;2%;10% 2%;3%;10%

N021502 N021501

001 001

Jul 21, 2006 Oct 02, 2006

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

OTC DRUG PRODUCT LIST

AVOBENZONE; ECAMSULE; OCTOCRYLENE; TITANIUM DIOXIDE
CREAM; TOPICAL

ANTHELIOS 20

+ LOREAL USA ANTHELIOS 40 + LOREAL USA +

4 - 2 (of 19)

2%;2%;10%;2% 2%;3%;10%;5% 2%;3%;10%;5%

N021471 N022009 N022009

001 001 002

Oct 05, 2006 Mar 31, 2008 Oct 29, 2009

AVOBENZONE; OCTINOXATE; OXYBENZONE

LOTION; TOPICAL

SHADE UVAGUARD

+ SCHERING PLOUGH

3%;7.5%;3%

N020045

001

Dec 07, 1992

BENTOQUATAM
LOTION; TOPICAL

IVY BLOCK

+ STAND HOMEOPATH

5%

N020532

001

Aug 26, 1996

BUTENAFINE HYDROCHLORIDE
CREAM; TOPICAL

LOTRIMIN ULTRA

+ SCHERING PLOUGH

1%

N021307

001

Dec 07, 2001

BUTOCONAZOLE NITRATE
CREAM; VAGINAL

FEMSTAT 3

+ BAYER

2%

N020421

001

Dec 21, 1995

CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE

TABLET, CHEWABLE; ORAL CALCIUM CARBONATE, FAMOTIDINE AND MAGNESIUM HYDROXIDE PERRIGO R AND D 800MG;10MG;165MG PEPCID COMPLETE + MERCK SHARP DOHME 800MG;10MG;165MG

A077355 N020958

001 001

Feb 06, 2008 Oct 16, 2000

CETIRIZINE HYDROCHLORIDE
CAPSULE; ORAL CETIRIZINE HYDROCHLORIDE ALLERGY BANNER PHARMACAPS 5MG + 10MG CETIRIZINE HYDROCHLORIDE HIVES RELIEF BANNER PHARMACAPS 5MG + 10MG SYRUP; ORAL CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY AMNEAL PHARMS 5MG/5ML APOTEX 5MG/5ML AUROBINDO PHARMA 5MG/5ML CYPRESS PHARM 5MG/5ML DR REDDYS LABS LTD 5MG/5ML PERRIGO R AND D 5MG/5ML RANBAXY 5MG/5ML SILARX 5MG/5ML SUN PHARM INDS INC 5MG/5ML TARO 5MG/5ML 5MG/5ML CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF AMNEAL PHARMS 5MG/5ML APOTEX 5MG/5ML AUROBINDO PHARMA 5MG/5ML CYPRESS PHARM 5MG/5ML DR REDDYS LABS LTD 5MG/5ML PERRIGO R AND D 5MG/5ML RANBAXY 5MG/5ML

N022429 N022429 N022429 N022429

001 004 003 002

Jul 23, 2009 Jul 23, 2009 Jul 23, 2009 Jul 23, 2009

A090765 A090188 A090750 A090300 A090474 A090254 A090183 A091130 A091327 A090182 A201546 A090765 A090188 A090750 A090300 A090474 A090254 A090183

002 002 002 001 002 002 002 001 001 002 001 001 001 001 002 001 001 001

Oct Apr Feb Oct Mar Apr Apr Apr Oct Apr May Oct Apr Feb Oct Mar Apr Apr

07, 22, 02, 10, 30, 09, 24, 22, 17, 22, 20, 07, 22, 02, 10, 30, 09, 24,

2009 2008 2010 2008 2009 2008 2008 2011 2011 2008 2011 2009 2008 2010 2008 2009 2008 2008

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

OTC DRUG PRODUCT LIST

CETIRIZINE HYDROCHLORIDE
SYRUP; ORAL CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF SILARX 5MG/5ML SUN PHARM INDS INC 5MG/5ML TARO 5MG/5ML 5MG/5ML CHILDREN'S ZYRTEC ALLERGY + MCNEIL CONSUMER 5MG/5ML CHILDREN'S ZYRTEC HIVES RELIEF + MCNEIL CONSUMER 5MG/5ML TABLET, CHEWABLE; ORAL CETIRIZINE HYDROCHLORIDE ALLERGY CARACO 5MG 10MG SANDOZ 5MG 10MG CETIRIZINE HYDROCHLORIDE HIVES RELIEF CARACO 5MG 10MG CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY SUN PHARMA GLOBAL 5MG 10MG CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF SUN PHARMA GLOBAL 5MG 10MG CHILDREN'S ZYRTEC ALLERGY PFIZER 5MG + 10MG CHILDREN'S ZYRTEC HIVES RELIEF PFIZER 5MG + 10MG TABLET, ORALLY DISINTEGRATING; ORAL ZYRTEC ALLERGY + MCNEIL CONSUMER 10MG TABLET; ORAL CETIRIZINE HYDROCHLORIDE ALLERGY ACTAVIS ELIZABETH 5MG 10MG AMNEAL PHARMS NY 5MG 10MG APOTEX INC 5MG 10MG CADISTA PHARMS 5MG 10MG CARACO 5MG 10MG CONTRACT PHARMA 5MG 10MG DR REDDYS LABS LTD 5MG 10MG MYLAN 5MG 10MG ORCHID HLTHCARE 5MG 10MG PERRIGO R AND D 5MG 10MG RANBAXY 5MG 10MG SANDOZ 5MG 10MG TARO 5MG 5MG TORRENT PHARMS LLC 5MG 10MG

4 - 3 (of 19)

A091130 A091327 A090182 A201546 N022155 N022155

002 002 001 002 002 001

Apr Oct Apr May

22, 17, 22, 20,

2011 2011 2008 2011

Nov 16, 2007 Nov 16, 2007

A077631 A077631 A078692 A078692 A077631 A077631 A090142 A090142 A090142 A090142 N021621 N021621 N021621 N021621

004 003 001 002 001 002 001 002 003 004 003 004 005 006

Jan Jan Feb Feb

11, 11, 14, 14,

2008 2008 2008 2008

Jan 11, 2008 Jan 11, 2008 Aug 30, 2011 Aug 30, 2011 Aug 30, 2011 Aug 30, 2011 Nov 16, 2007 Nov 16, 2007 Nov 16, 2007 Nov 16, 2007

N022578

001

Sep 03, 2010

A078615 A078615 A078780 A078780 A078317 A078317 A078933 A078933 A077499 A077499 A076047 A076047 A078343 A078343 A076677 A076677 A078862 A078862 A078336 A078336 A077498 A077498 A077946 A077946 A078072 A078072 A079191 A079191

003 004 001 004 001 002 001 002 001 002 001 002 004 003 001 002 001 002 001 002 001 002 001 002 001 003 001 004

Dec Dec Jan Jan Dec Dec Jun Jun Dec Dec Dec Dec Jan Jan Dec Dec Feb Feb Dec Dec Dec Dec Dec Dec Jul Jul Apr Apr

28, 28, 21, 21, 27, 27, 15, 15, 27, 27, 27, 27, 15, 15, 27, 27, 19, 19, 27, 27, 27, 27, 27, 27, 22, 22, 15, 15,

2007 2007 2010 2010 2007 2007 2010 2010 2007 2007 2007 2007 2008 2008 2007 2007 2009 2009 2007 2007 2007 2007 2007 2007 2009 2009 2010 2010

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

OTC DRUG PRODUCT LIST

CETIRIZINE HYDROCHLORIDE
TABLET; ORAL CETIRIZINE HYDROCHLORIDE ALLERGY UNICHEM 5MG 10MG UNIQUE PHARM LABS 5MG 10MG WOCKHARDT 5MG 10MG CETIRIZINE HYDROCHLORIDE HIVES CADISTA PHARMS 5MG 10MG CARACO 5MG 10MG DR REDDYS LABS LTD 5MG 10MG MYLAN 5MG 10MG ORCHID HLTHCARE 5MG 10MG PERRIGO R AND D 5MG 10MG RANBAXY 5MG 10MG UNICHEM 5MG 10MG UNIQUE PHARM LABS 5MG 10MG CETIRIZINE HYDROCHLORIDE HIVES RELIEF AMNEAL PHARMS NY 5MG 10MG TARO 10MG 10MG TORRENT PHARMS LLC 5MG 10MG ZYRTEC ALLERGY MCNEIL CONSUMER 5MG + 10MG ZYRTEC HIVES RELIEF MCNEIL CONSUMER 5MG + 10MG

4 - 4 (of 19)

A078680 A078680 A077829 A077829 A078427 A078427 A078933 A078933 A077499 A077499 A078343 A078343 A076677 A076677 A078862 A078862 A078336 A078336 A077498 A077498 A078680 A078680 A077829 A077829 A078780 A078780 A078072 A078072 A079191 A079191 N019835 N019835 N019835 N019835

003 004 001 004 003 004 003 004 003 004 001 002 004 003 003 004 003 004 003 004 001 002 003 002 003 002 002 004 003 002 003 004 005 006

Jun Jun Aug Aug Dec Dec Jun Jun Dec Dec Jan Jan Dec Dec Feb Feb Dec Dec Dec Dec Jun Jun Aug Aug Jan Jan Jul Jul Apr Apr

26, 26, 26, 26, 28, 28, 15, 15, 27, 27, 15, 15, 27, 27, 19, 19, 27, 27, 27, 27, 26, 26, 26, 26, 21, 21, 22, 22, 15, 15,

2009 2009 2009 2009 2007 2007 2010 2010 2007 2007 2008 2008 2007 2007 2009 2009 2007 2007 2007 2007 2009 2009 2009 2009 2010 2010 2009 2009 2010 2010

Nov 16, 2007 Nov 16, 2007 Nov 16, 2007 Nov 16, 2007

CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

TABLET, EXTENDED RELEASE; ORAL CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE IVAX SUB TEVA PHARMS 5MG;120MG SANDOZ 5MG;120MG ZYRTEC-D 12 HOUR + MCNEIL 5MG;120MG

A077170 A077991 N021150

001 001 002

Feb 25, 2008 Mar 05, 2008 Nov 09, 2007

CHLORHEXIDINE GLUCONATE
AEROSOL, METERED; TOPICAL

EXIDINE

+ XTTRIUM CLOTH; TOPICAL

CHLORHEXIDINE GLUCONATE

+ SAGE PRODS SOLUTION; TOPICAL BRIAN CARE SOAPCO CHG SCRUB ECOLAB CIDA-STAT ECOLAB

4%

N019127

001

Dec 24, 1984

2%

N021669

001

Apr 25, 2005

4% 4% 2%

A071419 N019258 N019258

001 002 001

Dec 17, 1987 Jul 22, 1986 Jul 22, 1986

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

OTC DRUG PRODUCT LIST

CHLORHEXIDINE GLUCONATE
SOLUTION; TOPICAL DYNA-HEX XTTRIUM EXIDINE + XTTRIUM HIBICLENS + MOLNLYCKE HLTH
HIBISTAT
+ MOLNLYCKE HLTH SPONGE; TOPICAL BIOSCRUB GRIFFEN CHLORHEXIDINE GLUCONATE BECTON DICKINSON PHARMASEAL SCRUB CARE + CAREFUSION

4 - 5 (of 19)

0.75% 2% 4% 4% 0.5%

N020111 N019422 N019125 N017768 N018300

001 001 001

001
001

Sep 11, 1997 Dec 17, 1985 Dec 24, 1984

4% 4% 4%

N019822 A072525 N019793

001 001 001

Mar 31, 1989 Oct 24, 1989 Dec 02, 1988

CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL

SPONGE; TOPICAL

CHLORAPREP ONE-STEP

+ CAREFUSION 2%;70% (3ML) + 2%;70% (10.5ML) + 2%;70% (26ML) CHLORAPREP ONE-STEP FREPP + CAREFUSION 2%;70% (1.5ML) CHLORAPREP WITH TINT + CAREFUSION 2%;70% (26ML) + 2%;70% (10.5ML) + 2%;70% (3ML) SWAB; TOPICAL

CHLORAPREP ONE-STEP SEPP

+ CARDINAL HLTH 2%;70% (0.67ML) CHLORAPREP SINGLE SWABSTICK + CARDINAL HLTH 2%;70% (1.75ML) CHLORAPREP TRIPLE SWABSTICK + CARDINAL HLTH 2%;70% (5.25ML) CHLORASCRUB MAXI SWABSTICK + 3M INFECTION 3.15%;70% (5.1ML) CHLORASCRUB SWAB + 3M INFECTION 3.15%;70% (1ML) CHLORASCRUB SWABSTICK + 3M INFECTION 3.15%;70% (1.6ML)

N020832 N020832 N020832 N020832 N020832 N020832 N020832

001 004 006 003 002 005 007

Jul 14, 2000 Aug 20, 2003 Nov 21, 2006 Apr 26, 2002 May 03, 2005 Apr 03, 2006 Oct 10, 2006

N021555 N021555 N021555 N021524 N021524 N021524

001 002 003 003 001 002

Oct 07, 2002 May 10, 2005 Jun 10, 2009 Jun 03, 2005 Jun 03, 2005 Jun 03, 2005

CHLORPHENIRAMINE MALEATE
TABLET, EXTENDED RELEASE; ORAL CHLORPHENIRAMINE MALEATE AVANTHI INC 12MG CHLOR-TRIMETON + SCHERING PLOUGH 12MG

A040829 N007638

001 002

May 13, 2009

CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE

TABLET; ORAL

ADVIL ALLERGY AND CONGESTION RELIEF
+ PFIZER CONS HLTHCARE 4MG;200MG;10MG

N022113

001

Dec 21, 2011

CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE

SUSPENSION; ORAL

CHILDREN'S ADVIL ALLERGY SINUS
+ WYETH CONS 1MG/5ML;100MG/5ML;15MG/5ML
TABLET; ORAL

ADVIL ALLERGY SINUS
+ WYETH CONS 2MG;200MG;30MG

N021587

001

Feb 24, 2004

N021441

001

Dec 19, 2002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

OTC DRUG PRODUCT LIST

CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE
TABLET, EXTENDED RELEASE; ORAL

CHLOR-TRIMETON

+ SCHERING PLOUGH 8MG;120MG

4 - 6 (of 19)

N018397

001

CIMETIDINE
TABLET; ORAL CIMETIDINE APOTEX CONTRACT PHARMACAL IVAX SUB TEVA PHARMS PERRIGO WATSON LABS TAGAMET HB + GLAXOSMITHKLINE

100MG 200MG 200MG 200MG 200MG 200MG 200MG 200MG

A074948 A074948 A074961 A074963 A075345 A075285 A075425 N020238

001 002 001 001 001 001 001 002

Jun Jul Jun Jun Jun Oct Jul

19, 26, 19, 19, 16, 29, 29,

1998 2002 1998 1998 1999 1998 1999

Aug 21, 1996

CLEMASTINE FUMARATE
TABLET; ORAL CLEMASTINE FUMARATE PERRIGO SANDOZ TAVIST-1 + NOVARTIS

1.34MG 1.34MG 1.34MG

A074512 A073458 N020925

001 001 001

Nov 22, 1995 Oct 31, 1993 Aug 21, 1992

CLOTRIMAZOLE
CREAM, TABLET; TOPICAL, VAGINAL

GYNE-LOTRIMIN 3 COMBINATION PACK

+ SCHERING PLOUGH 1%,200MG GYNE-LOTRIMIN COMBINATION PACK + SCHERING PLOUGH 1%,100MG MYCELEX-7 COMBINATION PACK BAYER PHARMS 1%,100MG CREAM; VAGINAL CLOTRIMAZOLE ACTAVIS MID ATLANTIC 1% TARO 1% GYNE-LOTRIMIN + SCHERING PLOUGH 1% GYNE-LOTRIMIN 3 + SCHERING PLOUGH 2% MYCELEX-7 BAYER PHARMS 1% TRIVAGIZOLE 3 TARO 2% TABLET; VAGINAL

GYNE-LOTRIMIN

+ SCHERING PLOUGH 100MG GYNE-LOTRIMIN 3 + SCHERING PLOUGH 200MG MYCELEX-7 BAYER PHARMS 100MG

N020526 N020289 N020389

002 002 002

Jul 29, 1996 Apr 26, 1993 Jun 23, 1994

A074165 A072641 N018052 N020574 N018230 N021143

001 001 002 001 002 001

Jul 16, 1993 Dec 04, 1995 Nov 30, 1990 Nov 24, 1998 Dec 26, 1991 Apr 12, 2000

N017717 N020525 N018182

002 001 002

Nov 30, 1990 Jul 29, 1996 Dec 26, 1991

CROMOLYN SODIUM
SPRAY, METERED; NASAL

CROMOLYN SODIUM

+ BAUSCH AND LOMB HH AND P PERRIGO

5.2MG/SPRAY 5.2MG/SPRAY 5.2MG/SPRAY

A075702 A077976 A075427

001 001 001

Jul 03, 2001 Sep 07, 2007 Dec 12, 2001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

OTC DRUG PRODUCT LIST

DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE
TABLET, EXTENDED RELEASE; ORAL DISOPHROL SCHERING PLOUGH 6MG;120MG DRIXORAL + SCHERING PLOUGH 6MG;120MG

4 - 7 (of 19)

N013483 N013483

004 003

Sep 13, 1982 Sep 13, 1982

DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN

TABLET, EXTENDED RELEASE; ORAL MUCINEX DM RECKITT BENCKISER 30MG;600MG + 60MG;1.2GM

N021620 N021620

002 001

Apr 29, 2004 Apr 29, 2004

DEXTROMETHORPHAN POLISTIREX
SUSPENSION, EXTENDED RELEASE; ORAL

DELSYM

+ RECKITT BENCKISER EQ 30MG HBR/5ML

N018658

001

Oct 08, 1982

DIPHENHYDRAMINE CITRATE; IBUPROFEN

TABLET; ORAL

ADVIL PM

+ PFIZER CONS HLTHCARE 38MG;200MG IBUPROFEN AND DIPHENHYDRAMINE CITRATE DR REDDYS LABS LTD 38MG;200MG PERRIGO R AND D 38MG;200MG

N021394 A090619 A079113

001 001 001

Dec 21, 2005 Jul 08, 2009 Dec 22, 2008

DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN

CAPSULE; ORAL

ADVIL PM

+ WYETH CONS

25MG;EQ 200MG FREE ACID AND POTASSIUM SALT IBUPROFEN AND DIPHENHYDRAMINE BANNER PHARMACAPS 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT

N021393

001

Dec 21, 2005

A090397

001

Nov 22, 2010

DOCOSANOL
CREAM; TOPICAL

ABREVA

+ GLAXOSMITHKLINE

10%

N020941

001

Jul 25, 2000

DOXYLAMINE SUCCINATE
TABLET; ORAL DOXYLAMINE SUCCINATE LNK PERRIGO UNISOM + CHATTEM

25MG 25MG 25MG

A040564 A040167 N018066

001 001 001

Aug 27, 2004 Sep 18, 1996

EPINEPHRINE
AEROSOL, METERED; INHALATION EPINEPHRINE ARMSTRONG PHARMS 0.2MG/INH

A087907

001

May 23, 1984

FAMOTIDINE
TABLET, CHEWABLE; ORAL FAMOTIDINE PERRIGO PEPCID AC + MERCK SHARP DOHME TABLET; ORAL FAMOTIDINE DR REDDYS LABS LTD IVAX SUB TEVA PHARMS

10MG 20MG

A075715 N020801

001 002

Aug 22, 2003 Dec 17, 2007

10MG 20MG 10MG

A075758 A077367 A075512

001 001 001

Aug 17, 2001 Sep 25, 2006 Jul 26, 2001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

OTC DRUG PRODUCT LIST

FAMOTIDINE
TABLET; ORAL FAMOTIDINE MYLAN PERRIGO RANBAXY SANDOZ TEVA WATSON LABS WOCKHARDT PEPCID AC MERCK SHARP DOHME + PEPCID AC (GELTAB) MERCK SHARP DOHME

4 - 8 (of 19)

10MG 10MG 20MG 10MG 20MG 10MG 10MG 10MG 10MG 20MG 10MG 20MG 10MG

A075674 A075400 A077351 A090283 A090283 A076101 A075312 A075404 A077146 A090837 N020325 N020325 N020902

001 001 001 001 002 001 001 001 001 001 001 002 001

Dec Mar Sep Nov Nov Oct May Nov Mar Aug

21, 18, 25, 17, 17, 21, 31, 28, 07, 04,

2001 2005 2006 2009 2009 2002 2001 2001 2005 2010

Apr 28, 1995 Sep 23, 2003 Aug 05, 1999

FEXOFENADINE HYDROCHLORIDE
SUSPENSION; ORAL

CHILDREN'S ALLEGRA ALLERGY

+ SANOFI AVENTIS US 30MG/5ML CHILDREN'S ALLEGRA HIVES + SANOFI AVENTIS US 30MG/5ML TABLET, ORALLY DISINTEGRATING; ORAL

CHILDREN'S ALLEGRA ALLERGY

+ SANOFI AVENTIS US 30MG CHILDREN'S ALLEGRA HIVES + SANOFI AVENTIS US 30MG TABLET; ORAL ALLEGRA ALLERGY SANOFI AVENTIS US 60MG + 180MG ALLEGRA HIVES SANOFI AVENTIS US 60MG + 180MG CHILDREN'S ALLEGRA ALLERGY SANOFI AVENTIS US 30MG CHILDREN'S ALLEGRA HIVES SANOFI AVENTIS US 30MG CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY DR REDDYS LABS LTD 30MG MYLAN 30MG TEVA 30MG CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES DR REDDYS LABS LTD 30MG MYLAN 30MG TEVA 30MG FEXOFENADINE HYDROCHLORIDE ALLERGY DR REDDYS LABS LTD 60MG 180MG MYLAN 60MG 180MG TEVA 60MG 180MG FEXOFENADINE HYDROCHLORIDE HIVES DR REDDYS LABS LTD 60MG 180MG MYLAN 60MG 180MG TEVA 60MG 180MG

N201373 N201373

001 002

Jan 24, 2011 Jan 24, 2011

N021909 N021909

002 003

Jan 24, 2011 Jan 24, 2011

N020872 N020872 N020872 N020872 N020872 N020872 A076502 A077081 A076447 A076502 A077081 A076447 A076502 A076502 A077081 A077081 A076447 A076447 A076502 A076502 A077081 A077081 A076447 A076447

007 010 008 009 005 006 004 004 004 005 005 005 006 008 006 008 006 008 007 009 007 009 007 009

Jan 24, 2011 Jan 24, 2011 Jan 24, 2011 Jan 24, 2011 Jan 24, 2011 Jan 24, 2011 Apr 12, 2011 Jul 21, 2011 Apr 13, 2011 Apr 12, 2011 Jul 21, 2011 Apr 13, 2011 Apr Apr Jul Jul Apr Apr Apr Apr Jul Jul Apr Apr 12, 12, 21, 21, 13, 13, 12, 12, 21, 21, 13, 13, 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011 2011

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

OTC DRUG PRODUCT LIST

FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
TABLET, EXTENDED RELEASE; ORAL

ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION

+ SANOFI AVENTIS US 60MG;120MG ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION + SANOFI AVENTIS US 180MG;240MG FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE DR REDDYS LABS LTD 180MG;240MG

4 - 9 (of 19)

N020786 N021704 A079043

002 002 002

Jan 24, 2011 Jan 24, 2011 Jun 22, 2011

GUAIFENESIN
TABLET, EXTENDED RELEASE; GUAIFENESIN PERRIGO R AND D MUCINEX RECKITT BENCKISER + ORAL 600MG 600MG 1.2GM A078912 N021282 N021282 001 001 002 Nov 23, 2011 Jul 12, 2002 Dec 18, 2002

GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE

TABLET, EXTENDED RELEASE; ORAL MUCINEX D RECKITT BENCKISER 600MG;60MG + 1.2GM;120MG

N021585 N021585

001 002

Jun 22, 2004 Jun 22, 2004

IBUPROFEN

CAPSULE; ORAL

ADVIL LIQUI-GELS
+ WYETH CONS EQ 200MG FREE ADVIL MIGRAINE LIQUI-GELS + WYETH CONS EQ 200MG FREE IBUPROFEN AMNEAL PHARMS EQ 200MG FREE BANNER PHARMACAPS EQ 200MG FREE + CONTRACT PHARMACAL 200MG DR REDDYS LABS LTD EQ 200MG FREE MARKSANS PHARMA EQ 200MG FREE MIDOL LIQUID GELS + BANNER PHARMACAPS 200MG
SUSPENSION/DROPS; ORAL

CHILDREN'S MOTRIN
+ MCNEIL CONS 40MG/ML IBUPROFEN PERRIGO 40MG/ML TRIS PHARMA INC 40MG/ML PEDIATRIC ADVIL + WYETH CONS 100MG/2.5ML SUSPENSION; ORAL CHILDREN'S ADVIL WYETH CONS 100MG/5ML CHILDREN'S ADVIL-FLAVORED WYETH CONS 100MG/5ML CHILDREN'S ELIXSURE ALTERNA TCHP LLC 100MG/5ML CHILDREN'S IBUPROFEN PERRIGO 100MG/5ML CHILDREN'S MOTRIN + MCNEIL 100MG/5ML IBUPROFEN ACTAVIS MID ATLANTIC 100MG/5ML AMNEAL PHARMS 100MG/5ML TABLET, CHEWABLE; ORAL CHILDREN'S ADVIL WYETH CONS 50MG CHILDREN'S MOTRIN MCNEIL CONS 50MG

ACID AND POTASSIUM SALT ACID AND POTASSIUM SALT ACID AND POTASSIUM SALT ACID AND POTASSIUM SALT ACID AND POTASSIUM SALT ACID AND POTASSIUM SALT

N020402 N020402 A202300 A078682 A074782 A077338 A079205 N021472

001 002 001 001 001 001 001 001

Apr 20, 1995 Mar 16, 2000 Dec Mar Jul Jul Jun 23, 24, 06, 10, 26, 2011 2009 1998 2009 2009

Oct 18, 2002

N020603 A075217 A079058 N020812

001 001 001 001

Jun 10, 1996 Dec 16, 1998 Aug 31, 2009 Jan 30, 1998

N020589 N020589 N021604 A074937 N020516 A074916 A200457

001 002 001 001 001 001 001

Jun 27, 1996 Nov 07, 1997 Jan 07, 2004 Dec 22, 1998 Jun 16, 1995 Apr 30, 1999 Aug 18, 2011

N020944 N020601

001 001

Dec 18, 1998 Nov 15, 1996

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

OTC DRUG PRODUCT LIST

IBUPROFEN
TABLET, CHEWABLE; ORAL IBUPROFEN PERRIGO JUNIOR STRENGTH ADVIL WYETH CONS JUNIOR STRENGTH MOTRIN + MCNEIL CONS TABLET; ORAL ADVIL WYETH CONS IBUPROFEN AMNEAL PHARMS NY AVEMA PHARMA CONTRACT PHARMACAL

4 - 10 (of 19)

50MG 100MG 100MG 100MG

A076359 A076359 N020944 N020601

001 002 002 003

Jan 16, 2004 Jan 16, 2004 Dec 18, 1998 Nov 15, 1996

200MG 200MG 200MG 200MG 200MG 200MG 200MG 200MG 200MG 200MG 100MG 200MG 100MG 200MG 200MG 200MG 200MG 200MG 200MG 200MG 200MG 200MG 200MG 200MG 200MG 200MG 200MG 200MG 200MG

N018989 A071333 A072199 A076460 A071732 A071735 A072299 A073691 A074931 A075661 A076117 A079174 A076741 A075010 A075139 A091237 A091239 A073019 A070985 A071163 A070481 A072096 A075995 A077349 A079129 A091355 A071229 A071639 A070435 A071214 A071057 N020267 A075367 N020602 N019012 N019012 A071265 A072095

001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 002 001 001 003 004 001 001

May 18, 1984 Feb May Nov Sep Sep Jul Feb Jul Dec Nov Dec Jun Mar Mar Feb Feb Mar Oct Jul Sep Dec Mar Jun Mar Apr Apr Feb Mar 17, 23, 26, 10, 10, 01, 25, 20, 12, 20, 10, 17, 01, 01, 08, 01, 30, 02, 15, 24, 08, 14, 21, 28, 04, 01, 02, 05, 1987 1988 2003 1987 1987 1988 1994 1998 2001 2001 2010 2004 1999 1999 2011 2011 1994 1987 1986 1986 1987 2002 2005 2011 2011 1987 1988 1986

DR REDDYS LA DR REDDYS LABS INC GRANULES INDIA LNK

MARKSANS PHARMA MCNEIL MERRO PHARM OHM PAR PHARM PERRIGO PERRIGO R AND D SVADS HOLDINGS SA VINTAGE PHARMS

WATSON LABS IBUPROHM OHM LABS 200MG IBU-TAB 200 ALRA 200MG JUNIOR STRENGTH ADVIL WYETH CONS 100MG JUNIOR STRENGTH IBUPROFEN PERRIGO 100MG JUNIOR STRENGTH MOTRIN MCNEIL CONS 100MG MOTRIN IB + MCNEIL 200MG MOTRIN MIGRAINE PAIN + MCNEIL 200MG PROFEN CONTRACT PHARMACAL 200MG TAB-PROFEN PERRIGO 200MG

Dec 01, 1986 Aug 11, 1988 Dec 13, 1996 Apr 22, 1999 Jun 10, 1996 Dec 17, 1990 Feb 25, 2000 Oct 15, 1986 Dec 08, 1987

IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE

TABLET; ORAL

ADVIL CONGESTION RELIEF
+ WYETH CONS 200MG;10MG

N022565

001

May 27, 2010

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

OTC DRUG PRODUCT LIST

IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
CAPSULE; ORAL

ADVIL COLD AND SINUS

+ WYETH CONS

4 - 11 (of 19)

EQ 200MG FREE ACID AND POTASSIUM SALT;30MG

N021374

001

May 30, 2002

SUSPENSION; ORAL CHILDREN'S ADVIL COLD WYETH CONS 100MG/5ML;15MG/5ML CHILDREN'S MOTRIN COLD + MCNEIL CONS 100MG/5ML;15MG/5ML IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE PERRIGO 100MG/5ML;15MG/5ML TABLET; ORAL

ADVIL COLD AND SINUS

+ WYETH CONS 200MG;30MG IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE CONTRACT PHARMACAL 200MG;30MG DR REDDYS LABS LTD 200MG;30MG IBUPROHM COLD AND SINUS OHM LABS 200MG;30MG SINE-AID IB MCNEIL CONS 200MG;30MG

N021373 N021128 A076478

001 001 001

Apr 18, 2002 Aug 01, 2000 Nov 05, 2003

N019771 A075588 A077628 A074567 N019899

001 001 001 001 001

Sep 19, 1989 Apr 08, 2002 Aug 14, 2006 Apr 17, 2001 Dec 31, 1992

INSULIN RECOMBINANT HUMAN

INJECTABLE; INJECTION

HUMULIN R
+ LILLY HUMULIN R PEN + LILLY NOVOLIN R + NOVO NORDISK INC

100 UNITS/ML 100 UNITS/ML 100 UNITS/ML

N018780 N018780 N019938

001 005 001

Oct 28, 1982 Aug 06, 1998 Jun 25, 1991

INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN

INJECTABLE; INJECTION

HUMULIN 70/30
+ LILLY HUMULIN 70/30 PEN + LILLY NOVOLIN 70/30 + NOVO NORDISK INC

30 UNITS/ML;70 UNITS/ML 30 UNITS/ML;70 UNITS/ML 30 UNITS/ML;70 UNITS/ML

N019717 N019717 N019991

001 002 001

Apr 25, 1989 Aug 06, 1998 Jun 25, 1991

INSULIN SUSP ISOPHANE RECOMBINANT HUMAN

INJECTABLE; INJECTION

HUMULIN N
+ LILLY NOVOLIN N + NOVO NORDISK INC

100 UNITS/ML 100 UNITS/ML

N018781 N019959

001 001

Oct 28, 1982 Jul 01, 1991

IODINE POVACRYLEX; ISOPROPYL ALCOHOL

SPONGE; TOPICAL

DURAPREP
+ 3M +

EQ 0.7% IODINE;74% (6ML) EQ 0.7% IODINE;74% (26ML)

N021586 N021586

001 002

Sep 29, 2006 Sep 29, 2006

KETOCONAZOLE

SHAMPOO; TOPICAL

NIZORAL A-D
+ MCNEIL CONS

1%

N020310

001

Oct 10, 1997

KETOPROFEN

FILM; ORAL

NEXCEDE
+ NOVARTIS

12.5MG

N022470

001

Nov 25, 2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

OTC DRUG PRODUCT LIST

KETOTIFEN FUMARATE
SOLUTION/DROPS; OPHTHALMIC

ALAWAY

+ BAUSCH AND LOMB EQ KETOTIFEN FUMARATE AKORN EQ ALCON PHARMS LTD EQ APOTEX INC EQ ZADITOR + ALCON PHARMA EQ

4 - 12 (of 19)

0.025% BASE 0.025% BASE 0.025% BASE 0.025% BASE 0.025% BASE

N021996 A077958 A077200 A077354 N021066

001 001 001 001 002

Dec 01, 2006 Jul 26, 2007 Sep 02, 2008 May 09, 2006 Oct 19, 2006

LANSOPRAZOLE
CAPSULE, DELAYED REL PELLETS; ORAL

PREVACID 24 HR

+ NOVARTIS 15MG

N022327

001

May 18, 2009

LEVONORGESTREL
TABLET; ORAL LEVONORGESTREL PERRIGO R AND D + WATSON LABS PLAN B + TEVA WOMENS PLAN B ONE-STEP + DURAMED

0.75MG 0.75MG 0.75MG 1.5MG

A090740 A078665 N021045 N021998

001 001 002 001

Dec 30, 2010 Aug 28, 2009 Aug 24, 2006 Jul 10, 2009

LOPERAMIDE HYDROCHLORIDE
CAPSULE; ORAL LOPERAMIDE HYDROCHLORIDE BANNER PHARMACAPS 1MG + 2MG
SOLUTION; ORAL

IMODIUM A-D
+ MCNEIL CONS 1MG/5ML LOPERAMIDE HYDROCHLORIDE HI TECH PHARMA 1MG/5ML PERRIGO 1MG/5ML ROXANE 1MG/5ML WOCKHARDT 1MG/5ML
SUSPENSION; ORAL

IMODIUM A-D
+ MCNEIL CONS 1MG/7.5ML LOPERAMIDE HYDROCHLORIDE PERRIGO R AND D 1MG/7.5ML
TABLET, CHEWABLE; ORAL

IMODIUM A-D EZ CHEWS
+ MCNEIL 2MG
TABLET; ORAL

IMODIUM A-D
+ MCNEIL CONS 2MG LOPERAMIDE HYDROCHLORIDE CONTRACT PHARMACAL 2MG LNK 2MG OHM LABS 2MG PERRIGO 2MG

N021855 N021855

001 002

Aug 04, 2005 Aug 04, 2005

N019487 A074352 A073243 A073079 A074730

001 001 001 001 001

Mar 01, 1988 Nov Jan Apr Aug 17, 21, 30, 28, 1995 1992 1992 1997

N019487 A091292

002 001

Jul 08, 2004 May 20, 2011

N020448

001

Jul 24, 1997

N019860 A073254 A076497 A074091 A075232

001 001 001 001 001

Nov 22, 1989 Jul Jun Dec Jan 30, 10, 10, 06, 1993 2003 1992 2000

LOPERAMIDE HYDROCHLORIDE; SIMETHICONE

TABLET, CHEWABLE; ORAL

IMODIUM MULTI-SYMPTOM RELIEF
+ MCNEIL 2MG;125MG LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE PERRIGO 2MG;125MG

N020606 A076029

001 001

Jun 26, 1996 Aug 30, 2002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

OTC DRUG PRODUCT LIST

LOPERAMIDE HYDROCHLORIDE; SIMETHICONE
TABLET; ORAL

IMODIUM MULTI-SYMPTOM RELIEF

+ MCNEIL CONS 2MG;125MG LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE RANBAXY 2MG;125MG

4 - 13 (of 19)

N021140 A077500

001 001

Nov 30, 2000 Sep 06, 2006

LORATADINE
CAPSULE; ORAL

CLARITIN

+ SCHERING PLOUGH 10MG SUSPENSION; ORAL

LORATADINE

+ TARO 1MG/ML SYRUP; ORAL

CLARITIN

+ SCHERING PLOUGH 1MG/ML LORATADINE APOTEX INC 1MG/ML PERRIGO 1MG/ML RANBAXY 1MG/ML SILARX 1MG/ML TARO 1MG/ML TEVA 1MG/ML WOCKHARDT 1MG/ML TABLET, CHEWABLE; ORAL

CHILDREN'S CLARITIN

+ SCHERING PLOUGH 5MG TABLET, ORALLY DISINTEGRATING; ORAL ALAVERT WYETH CONS 10MG CLARITIN HIVES RELIEF REDITAB + SCHERING PLOUGH 10MG CLARITIN REDITABS + SCHERING PLOUGH 5MG + 10MG LORATADINE IMPAX LABS 10MG WATSON LABS FLORIDA 10MG WYETH CONS 10MG LORATADINE REDIDOSE RANBAXY 10MG TABLET; ORAL CLARITIN + SCHERING PLOUGH 10MG CLARITIN HIVES RELIEF + SCHERING PLOUGH 10MG LORATADINE APOTEX INC 10MG MYLAN 10MG 10MG 10MG PERRIGO 10MG RANBAXY 10MG SANDOZ 10MG

N021952

001

Jun 16, 2008

N021734

001

Oct 04, 2005

N020641 A075565 A075728 A076529 A077421 A076805 A075505 A075815

002 001 001 001 001 001 001 001

Nov 27, 2002 Oct Aug Aug Jun Aug Nov Aug 05, 20, 20, 29, 20, 07, 20, 2004 2004 2004 2006 2004 2003 2004

N021891

001

Aug 23, 2006

N021375 N020704 N021993 N020704 A076011 A075990 A075822 A077153

001 003 001 002 001 001 001 001

Dec 19, 2002 Nov 19, 2003 Dec 12, 2006 Nov 27, 2002 Sep 29, 2003 Nov 03, 2003 Feb 10, 2003 Apr 11, 2007

N019658 N019658 A076471 A075790 A076154 A078447 A076301 A076134 A075209

002 003 001 001 001 001 001 001 001

Nov 27, 2002 Nov 19, 2003 Feb Nov Aug Aug Jun Aug Jan 14, 07, 20, 12, 25, 18, 21, 2006 2008 2003 2011 2004 2003 2003

LORATADINE; PSEUDOEPHEDRINE SULFATE

TABLET, EXTENDED RELEASE; ORAL

CLARITIN-D

+ SCHERING PLOUGH 5MG;120MG CLARITIN-D 24 HOUR + SCHERING PLOUGH 10MG;240MG LORATADINE AND PSEUDOEPHEDRINE SULFATE IMPAX LABS 5MG;120MG 10MG;240MG

N019670 N020470 A076050 A075989

002 002 001 001

Nov 27, 2002 Nov 27, 2002 Jan 30, 2003 Mar 04, 2004

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

OTC DRUG PRODUCT LIST

LORATADINE; PSEUDOEPHEDRINE SULFATE
TABLET, EXTENDED RELEASE; ORAL LORATADINE AND PSEUDOEPHEDRINE SULFATE RANBAXY 10MG;240MG WATSON LABS FLORIDA 5MG;120MG 10MG;240MG

4 - 14 (of 19)

A076557 A076208 A075706

001 001 001

Sep 22, 2004 Jan 28, 2004 Feb 21, 2003

MENTHOL; METHYL SALICYLATE

PATCH; TOPICAL

SALONPAS

+ HISAMITSU

3%;10%

N022029

001

Feb 20, 2008

MICONAZOLE NITRATE
CREAM, SUPPOSITORY; TOPICAL, VAGINAL MICONAZOLE 7 COMBINATION PACK G AND W LABS 2%,100MG MICONAZOLE NITRATE PERRIGO R AND D 2%,1.2GM MICONAZOLE NITRATE COMBINATION PACK PERRIGO 2%,200MG MONISTAT 1 COMBINATION PACK + INSIGHT PHARMS 2%,1.2GM MONISTAT 7 COMBINATION PACK + INSIGHT PHARMS 2%,100MG MONISTAT-3 COMBINATION PACK + INSIGHT PHARMS 2%,200MG M-ZOLE 3 COMBINATION PACK ACTAVIS MID ATLANTIC 2%,200MG CREAM; TOPICAL, VAGINAL MICONAZOLE 3 COMBINATION PACK PERRIGO 2%,4% MONISTAT 3 COMBINATION PACK INSIGHT PHARMS 2%,4% MONISTAT 3 COMBINATION PACK (PREFILLED) + INSIGHT PHARMS 2%,4% CREAM; VAGINAL MICONAZOLE 3 TARO 4% MICONAZOLE 7 ACTAVIS MID ATLANTIC 2% MICONAZOLE NITRATE G AND W LABS 2% PERRIGO 2% PERRIGO R AND D 4% TARO 2% MONISTAT 3 + INSIGHT PHARMS 4% MONISTAT 7 + INSIGHT PHARMS 2% SUPPOSITORY; VAGINAL MICONAZOLE NITRATE ACTAVIS MID ATLANTIC 100MG G AND W LABS 100MG + PERRIGO 100MG MONISTAT 7 + INSIGHT PHARMS 100MG

A076585 A079114 A075329 N021308 N020288 N020670 A074926

001 001 001 001 002 002 001

Mar 26, 2004 Jun 02, 2010 Apr 20, 1999 Jun 29, 2001 Apr 26, 1993 Apr 16, 1996 Apr 16, 1999

A076357 N021261 N021261

001 003 001

Mar 30, 2004 Jun 17, 2003 Feb 02, 2001

A076773 A074164 A074366 A074760 A091366 A074444 N020827 N017450

001 001 001 001 001 001 001 002

Mar 02, 2005 Mar 29, 1996 Feb May Jan Jan 22, 15, 15, 13, 1996 1997 2010 1997

Mar 30, 1998 Feb 15, 1991

A073507 A074414 A074395 N018520

001 001 001 002

Nov 19, 1993 Apr 30, 1997 Mar 20, 1997 Feb 15, 1991

MINOXIDIL
AEROSOL, FOAM; TOPICAL

MEN'S ROGAINE

+ JOHNSON AND JOHNSON MINOXIDIL PERRIGO ISRAEL

5% 5%

N021812 A091344

001 001

Jan 20, 2006 Apr 28, 2011

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

OTC DRUG PRODUCT LIST

MINOXIDIL
SOLUTION; TOPICAL MINOXIDIL (FOR MEN) ACTAVIS MID ATLANTIC 2% HI TECH PHARMA 2% NOVEX 2% PERRIGO 2% WOCKHARDT 2% MINOXIDIL (FOR WOMEN) HI TECH PHARMA 2% NOVEX 2% PERRIGO 2% MINOXIDIL EXTRA STRENGTH (FOR MEN) ACTAVIS MID ATLANTIC 5% AVACOR PRODS 5% NOVEX 5% PERRIGO 5% PERRIGO NEW YORK 5% WOCKHARDT 5% ROGAINE (FOR MEN) + JOHNSON AND JOHNSON 2% ROGAINE (FOR WOMEN) + JOHNSON AND JOHNSON 2% ROGAINE EXTRA STRENGTH (FOR MEN) + JOHNSON AND JOHNSON 5% THEROXIDIL EI INC 2% 5%

4 - 15 (of 19)

A074588 A074731 A074924 A075357 A074767 A074731 A074924 A075357 A075518 A075619 A075839 A075598 A075737 A075438 N019501 N019501 N020834 A078176 A076239

001 001 001 001 001 002 002 002 001 001 001 001 001 001 002 003 001 001 001

Apr Dec Apr Jul Feb

05, 24, 29, 30, 28,

1996 1996 1998 1999 1997

May 11, 2005 Apr 29, 1998 Jul 30, 1999 Nov Nov Oct Jun Mar Feb 17, 17, 01, 13, 15, 27, 2000 2000 2001 2001 2002 2003

Feb 09, 1996 Feb 09, 1996 Nov 14, 1997 Nov 09, 2007 Aug 24, 2004

NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE

SOLUTION/DROPS; OPHTHALMIC NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE ALTAIRE PHARMS INC 0.02675%;0.315% NAPHCON-A + ALCON 0.025%;0.3% OPCON-A + BAUSCH AND LOMB 0.02675%;0.315% VISINE-A + JOHNSON AND JOHNSON 0.025%;0.3%

A078208 N020226 N020065 N020485

001 001 001 001

Sep 27, 2010 Jun 08, 1994 Jun 08, 1994 Jan 31, 1996

NAPROXEN SODIUM

CAPSULE; ORAL

NAPROXEN SODIUM
+ BANNER PHARMACAPS
TABLET; ORAL

ALEVE
+ BAYER NAPROXEN SODIUM AMNEAL PHARMS NY CONTRACT PHARMACAL DR REDDYS LABS INC GRANULES INDIA MARKSANS PHARMA PERRIGO RANBAXY LABS LTD SANDOZ

EQ 200MG BASE

N021920

001

Feb 17, 2006

EQ 200MG BASE EQ EQ EQ EQ EQ EQ EQ EQ EQ 200MG 200MG 200MG 200MG 200MG 200MG 200MG 200MG 200MG BASE BASE BASE BASE BASE BASE BASE BASE BASE

N020204 A079096 A074635 A074789 A075168 A091353 A090545 A074661 A091183 A074646

002 001 001 001 001 001 001 001 001 001

Jan 11, 1994 Dec Jan Feb Jul Sep Mar Jan May Jan 16, 13, 27, 28, 20, 16, 13, 20, 13, 2008 1997 1997 1998 2011 2011 1997 2011 1997

NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE

TABLET, EXTENDED RELEASE; ORAL

ALEVE-D SINUS & COLD
+ BAYER 200MG;120MG NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE DR REDDYS LABS INC EQ 220MG BASE;120MG

N021076 A077381

001 001

Nov 29, 1999 Sep 27, 2006

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

OTC DRUG PRODUCT LIST

NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE
TABLET, EXTENDED RELEASE; ORAL NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE PERRIGO EQ 200MG BASE;120MG

4 - 16 (of 19)

A076518

001

Mar 17, 2004

NICOTINE
FILM, EXTENDED RELEASE; TRANSDERMAL

HABITROL

+ NOVARTIS 7MG/24HR + 14MG/24HR + 21MG/24HR NICODERM CQ + SANOFI AVENTIS US 7MG/24HR + 14MG/24HR + 21MG/24HR NICOTINE AVEVA 7MG/24HR 14MG/24HR 21MG/24HR

N020076 N020076 N020076 N020165 N020165 N020165 A074645 A074611 A074612

004 005 006 006 005 004 001 001 001

Nov 12, 1999 Nov 12, 1999 Nov 12, 1999 Aug 02, 1996 Aug 02, 1996 Aug 02, 1996 Oct 20, 1997 Oct 20, 1997 Oct 20, 1997

NICOTINE POLACRILEX

GUM, CHEWING; BUCCAL

NICORETTE
+ GLAXOSMITHKLINE + NICORETTE (MINT) GLAXOSMITHKLINE NICOTINE POLACRILEX IVAX SUB TEVA PHARMS PERRIGO

EQ EQ EQ EQ

2MG 2MG 4MG 4MG

BASE BASE BASE BASE

N018612 N018612 N020066 N020066 N018612 N020066 A076880 A077850 A076775 A076776 A076777 A076778 A076779 A076789 A078325 A078547 A078967 A091349 A078326 A078546 A078968 A091354 A074507 A076569 A078699 A079044 A079216 A074707 A076568 A078697 A079038 A079219 A077658 A077656

002 004 002 004 003 003 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 002 001 001 001 001 001

Feb Sep Feb Sep

09, 25, 09, 25,

1996 2000 1996 2000

EQ 2MG BASE EQ 4MG BASE EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ 2MG 4MG 2MG 2MG 2MG 4MG 4MG 4MG 2MG 2MG 2MG 2MG 4MG 4MG 4MG 4MG 2MG 2MG 2MG 2MG 2MG 4MG 4MG 4MG 4MG 4MG BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE

Dec 23, 1998 Dec 23, 1998 Feb Feb Sep Sep Sep Sep Sep Sep Oct May Apr Jul Oct May Apr Jul Mar Jul Dec Jul Jul Mar Jul Dec Jul Jul 18, 18, 16, 16, 16, 16, 16, 16, 30, 24, 23, 20, 30, 24, 23, 20, 15, 29, 29, 08, 08, 19, 29, 29, 08, 08, 2009 2009 2004 2004 2004 2004 2004 2004 2006 2007 2008 2011 2006 2007 2008 2011 1999 2004 2008 2009 2009 1999 2004 2008 2009 2009

PERRIGO R AND D

WATSON LABS

THRIVE NOVARTIS TROCHE/LOZENGE; ORAL COMMIT GLAXOSMITHKLINE CONS +

EQ 2MG BASE EQ 4MG BASE

Jun 19, 2007 Jun 19, 2007

EQ 2MG BASE EQ 4MG BASE

N021330 N021330

001 002

Oct 31, 2002 Oct 31, 2002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

OTC DRUG PRODUCT LIST

NICOTINE POLACRILEX
TROCHE/LOZENGE; ORAL NICORETTE GLAXOSMITHKLINE CONS + NICOTINE POLACRILEX PERRIGO R AND D

4 - 17 (of 19)

EQ 2MG BASE EQ 4MG BASE EQ EQ EQ EQ EQ EQ 2MG 2MG 2MG 4MG 4MG 4MG BASE BASE BASE BASE BASE BASE

N022360 N022360 A077007 A090711 A090821 A077007 A090711 A090821

001 002 001 001 001 002 002 002

May 18, 2009 May 18, 2009 Jan Jul Jul Jan Jul Jul 31, 10, 10, 31, 10, 10, 2006 2009 2009 2006 2009 2009

NIZATIDINE
TABLET; ORAL

AXID AR

+ WYETH CONS

75MG

N020555

001

May 09, 1996

NONOXYNOL-9
SPONGE; VAGINAL

TODAY

+ AZTIQ PHARMA

1GM

N018683

001

Apr 01, 1983

OMEPRAZOLE
TABLET, DELAYED RELEASE; ORAL

OMEPRAZOLE

+ DEXCEL PHARMA 20MG

N022032

001

Dec 04, 2007

OMEPRAZOLE MAGNESIUM
CAPSULE, DELAYED RELEASE; ORAL

OMEPRAZOLE MAGNESIUM

+ DR REDDYS LABS LTD EQ 20MG BASE TABLET, DELAYED RELEASE; ORAL

PRILOSEC OTC

+ ASTRAZENECA EQ 20MG BASE

A078878

001

Jun 05, 2009

N021229

001

Jun 20, 2003

OMEPRAZOLE; SODIUM BICARBONATE

CAPSULE; ORAL

ZEGERID OTC

+ MSD CONSUMER

20MG;1.1GM

N022281

001

Dec 01, 2009

ORLISTAT
CAPSULE; ORAL

ALLI

+ GLAXOSMITHKLINE CONS

60MG

N021887

001

Feb 07, 2007

OXYMETAZOLINE HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC OCUCLEAR SCHERING PLOUGH 0.025% VISINE L.R. + JOHNSON AND JOHNSON 0.025%

N018471 N019407

001 001

May 30, 1986 Mar 31, 1989

PERMETHRIN
LOTION; TOPICAL

NIX

+ INSIGHT PHARMS PERMETHRIN ACTAVIS MID ATLANTIC PERRIGO NEW YORK

1% 1% 1%

N019918 A075014 A076090

001 001 001

May 02, 1990 Mar 28, 2000 Dec 20, 2001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

OTC DRUG PRODUCT LIST

PIPERONYL BUTOXIDE; PYRETHRINS
AEROSOL; TOPICAL

RID MOUSSE

+ BAYER HLTHCARE

4 - 18 (of 19)

4%;EQ 0.33% BASE

N021043

001

Mar 07, 2000

POLYETHYLENE GLYCOL 3350

FOR SOLUTION; ORAL GLYCOLAX KREMERS URBAN PHARMS

17GM/PACKET 17GM/SCOOPFUL

A090600 A090600 N022015 A078915 A078915 A090812 A091077 A090567 A090685 A090685

001 002 001 001 002 001 001 001 001 002

Oct 06, 2009 Oct 06, 2009 Oct 06, 2006 Oct Oct Oct Oct Oct Oct Oct 06, 06, 07, 06, 15, 06, 06, 2009 2009 2009 2009 2009 2009 2009

MIRALAX + SCHERING PLOUGH 17GM/SCOOPFUL POLYETHYLENE GLYCOL 3350 MYLAN 17GM/PACKET 17GM/SCOOPFUL NEXGEN PHARMA 17GM/SCOOPFUL NOVEL LABS INC 17GM/SCOOPFUL PADDOCK LLC 17GM/SCOOPFUL PERRIGO R AND D 17GM/PACKET 17GM/SCOOPFUL

POTASSIUM IODIDE
SOLUTION; ORAL

THYROSHIELD

+ FLEMING TABLET; ORAL IOSAT ANBEX + THYROSAFE + RECIP

65MG/ML

A077218

001

Jan 12, 2005

65MG 130MG 65MG

N018664 N018664 A076350

002 001 001

May 12, 2011 Oct 14, 1982 Sep 10, 2002

POVIDONE-IODINE
SOLUTION; TOPICAL

POVIDONE IODINE

+ ALLEGIANCE HLTHCARE SPONGE; TOPICAL

E-Z SCRUB 201

+ BECTON DICKINSON E-Z SCRUB 241 + BECTON DICKINSON

1%

N019522

001

Mar 31, 1989

20% 10%

N019240 N019476

001 001

Nov 29, 1985 Jan 07, 1987

PSEUDOEPHEDRINE HYDROCHLORIDE
TABLET, EXTENDED RELEASE; ORAL PSEUDOEPHEDRINE HYDROCHLORIDE PERRIGO 120MG RANBAXY 120MG SUDAFED 12 HOUR + MCNEIL CONS 120MG SUDAFED 24 HOUR + MCNEIL CONS 240MG

A075153 A077442 A073585 N020021

001 001 001 002

Feb 26, 1999 Sep 28, 2005 Oct 31, 1991 Dec 15, 1992

PSEUDOEPHEDRINE SULFATE
TABLET, EXTENDED RELEASE; ORAL

AFRINOL

+ SCHERING PLOUGH 120MG

N018191

001

PURIFIED WATER
SOLUTION; OPHTHALMIC

PUR-WASH

+ NIAGARA PHARMS

98.3%

N022305

001

Sep 01, 2011

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

OTC DRUG PRODUCT LIST

RANITIDINE HYDROCHLORIDE
TABLET; ORAL RANITIDINE HYDROCHLORIDE CONTRACT PHARMACAL EQ DR REDDYS LABS LTD EQ EQ IVAX SUB TEVA PHARMS EQ MYLAN EQ PERRIGO EQ PERRIGO R AND D EQ EQ SVADS HOLDINGS SA EQ TORPHARM EQ WATSON LABS EQ WOCKHARDT EQ EQ EQ ZANTAC 150 + BOEHRINGER INGELHEIM EQ EQ ZANTAC 75 BOEHRINGER INGELHEIM EQ

4 - 19 (of 19)

75MG BASE 75MG BASE 150MG BASE 75MG BASE 75MG BASE 75MG BASE 150MG BASE 150MG BASE 150MG BASE 75MG BASE 75MG BASE 75MG BASE 75MG BASE 150MG BASE 150MG BASE 150MG BASE 75MG BASE

A075094 A075294 A078192 A075296 A075497 A076195 A091429 A091429 A200536 A075167 A075212 A076760 A078884 A078653 N021698 N021698 N020520

001 001 001 001 001 001 001 002 001 001 001 001 001 001 001 002 001

Jun Mar Aug Jan Jan Aug May May Jun May Jan Feb Jul Nov

21, 28, 31, 14, 14, 30, 11, 11, 28, 04, 14, 24, 31, 26,

1999 2000 2007 2000 2000 2002 2011 2011 2011 2000 2000 2006 2008 2007

Aug 31, 2004 Mar 13, 2007 Dec 19, 1995

SODIUM CHLORIDE
AEROSOL, METERED; INHALATION

BRONCHO SALINE

+ BLAIREX 0.9%

N019912

001

Sep 03, 1992

SODIUM FLUORIDE; TRICLOSAN

PASTE; DENTAL

COLGATE TOTAL

+ COLGATE PALMOLIVE

0.24%;0.3%

N020231

001

Jul 11, 1997

TERBINAFINE
GEL; TOPICAL

LAMISIL AT

+ NOVARTIS

1%

N021958

001

Jul 24, 2006

TERBINAFINE HYDROCHLORIDE
CREAM; TOPICAL

LAMISIL

+ NOVARTIS 1% TERBINAFINE HYDROCHLORIDE TARO 1% SOLUTION; TOPICAL

LAMISIL AT

+ NOVARTIS 1% SPRAY; TOPICAL

LAMISIL AT

+ NOVARTIS 1%

N020980 A077511

001 001

Mar 09, 1999 Jul 02, 2007

N021124

001

Mar 17, 2000

N021124

002

Mar 17, 2000

TIOCONAZOLE
OINTMENT; VAGINAL TIOCONAZOLE PERRIGO VAGISTAT-1 + NOVARTIS

6.5% 6.5%

A075915 N020676

001 001

Nov 21, 2001 Feb 11, 1997

32nd EDITION - 2012- APPROVED DRUG PRODUCT LIST

5 - 1 of 5

DRUG PRODUCTS WITH APPROVAL UNDER SECTION 505 OF THE ACT

ADMINISTERED BY THE CENTER FOR BIOLOGICS EVALUATION AND RESEARCH LIST

ANTICOAGULANT 4% SODIUM CITRATE SOLUTION USP

INJECTABLE; INJECTION NONE MEDSEP CORPORATION

N760305

Jun 30, 1978

ANTICOAGULANT CITRATE DEXTROSE SOLUTION (ACD)

INJECTABLE; INJECTION CITRA LABS LLC ACD-A SOLUTION GAMBRO BCT INC ADSOL WITH ACD-A FENWAL INC ANTICOAGULANT CITRATE DEXTROSE SOLUTION FORMULA A HAEMONETICS CORP AS3 SOLUTION/ACD-A GAMBRO BCT INC N020037 A010228 N000922 A980728 N001214 ANDA ANDA Aug 26, 2003 Feb 25, 2002 Aug 29, 2002 Feb 06, 2002 May 29, 2002

ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP

INJECTABLE; INJECTION NONE FENWAL INC FRESENIUS MEDICAL CARE NORTH AMERICA MEDSEP CORPORATION MILES INC

N100855 N160918 N110912 A710497 N100102 ANDA

Jun 03, 1959 Mar 17, 1978 Sep 02, 1959

Dec 14, 1961

ANTICOAGULANT CITRATE PHOSPHATE 2X DEXTROSE SOLUTION (CP2D)

INJECTABLE; INJECTION CITRATE PHOSPHATE DOUBLE DEXTROSE/ADDITIVE SOLUTION 3 HAEMONETICS CORP

N000127

Jan 18, 2002

ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE SOLUTION

INJECTABLE; INJECTION NONE FRESENIUS MEDICAL CARE NORTH AMERICA TERUMO MEDICAL CORP

N780519 N820528

Apr 23, 1980 Nov 03, 1982

ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE SOLUTION (CPDA)

INJECTABLE; INJECTION CPDA-1 BLOOD-PACK UNIT (PL 146 PLASTIC) 250, 450, 500 ML BLOOD PACK UNITS FENWAL INC N770420

May 12, 1978

ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE SOLUTION USP

INJECTABLE; INJECTION BLOOD PACK UNIT CPDA-1 IN PLASTIC CONTAINER FENWAL INC

N940404

Jul 28, 1994

ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE-1 SOLUTION

INJECTABLE; INJECTION NONE MEDSEP CORPORATION

N800077

Nov 06, 1980

ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTION

INJECTABLE; INJECTION ADSOL IN PLASTIC CONTAINER FENWAL INC

N900223

Dec 27, 1991

32nd EDITION - 2012- APPROVED DRUG PRODUCT LIST

5 - 2 of 5

DRUG PRODUCTS WITH APPROVAL UNDER SECTION 505 OF THE ACT

ADMINISTERED BY THE CENTER FOR BIOLOGICS EVALUATION AND RESEARCH LIST

ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTION (CPD)

INJECTABLE; INJECTION MACOPRODUCTIONS SAS CPD/AS-1: MACOPHARMA LEUCOFLEX MTL1 LEUKOREDUCTION SYSTEM FOR BLOOD COMPONENTS KNOWN AS MTL1-WB MACOPRODUCTIONS SAS N040083 Nov 21, 2005 NONE GAMBRO BCT INC A070025 Jan 06, 2008

ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTION USP

INJECTABLE; INJECTION NONE FENWAL INC FRESENIUS MEDICAL CARE NORTH AMERICA MEDSEP CORPORATION MILES INC TERUMO MEDICAL CORP

N170401 N811012 N160907 N800222 N160527 N781211

Dec 06, 1977 Jun 28, 1983 May 16, 1973 Aug 23, 1982 Jun 22, 1970 Jun 10, 1981

ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTION USP WITH: AS-1: DEXTROSE USP; SODIUM CHLORIDE USP; MANNITOL USP; ADENINE
INJECTABLE; INJECTION ADSOL RED BLOOD CELL PRESERVATIVE SOLUTION FENWAL INC

N811104

May 16, 1983

ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTION USP WITH: AS-5: DEXTROSE USP; SODIUM CHLORIDE USP; MANNITOL USP; ADENINE
INJECTABLE; INJECTION OPTISOL RED BLOOD CELL PRESERVATIVE SOLUTION TERUMO MEDICAL CORP

N880217

Oct 07, 1988

ANTICOAGULANT CITRATE PHOSPHATE DOUBLE DEXTROSE SOLUTION WITH:

AS-3: CITRIC ACID USP; MONOBASIC SODIUM PHOSPHATE USP; SODIUM CHLORIDE USP; ADENINE;
DEXTROSE USP; SODIUM CITRATE USP

INJECTABLE; INJECTION AS-3 NUTRICEL ADDITIVE SYSTEM MEDSEP CORP 0.042GM/100ML;0.276GM/100ML; 0.410GM/100ML;0.30GM/100ML; 1.10GM/100ML;0.588GM/100ML

N820915

Oct 19, 1984

ANTICOAGULANT CITRATE PHOSPHATE DOUBLE DEXTROSE SOLUTION WITH:

AS-2: CITRIC ACID USP; DIBASIC SODIUM PHOSPHATE USP; SODIUM CHLORIDE USP; ADENINE;

DEXTROSE USP; SODIUM CITRATE USP

INJECTABLE; INJECTION AS-2 NUTRICEL ADDITIVE SYSTEM MEDSEP CORP 0.042GM/100ML;0.285GM/100ML; 0.718GM/100ML;0.017GM/100ML; 0.396GM/100ML;0.588GM/100ML

N820915

Sep 22, 1983

ANTICOAGULANT ETHYLENEDIAMINE TETRAACETIC ACID (EDTA)

INJECTABLE; INJECTION NONE FENWAL INC

N090480

Mar 07, 1955

ANTICOAGULANT HEPARIN SOLUTION USP

INJECTABLE; INJECTION NONE FRESENIUS MEDICAL CARE NORTH AMERICA

N770822

May 17, 1978

32nd EDITION - 2012- APPROVED DRUG PRODUCT LIST

5 - 3 of 5

DRUG PRODUCTS WITH APPROVAL UNDER SECTION 505 OF THE ACT

ADMINISTERED BY THE CENTER FOR BIOLOGICS EVALUATION AND RESEARCH LIST

ANTICOAGULANT SODIUM CITRATE 4% SOLUTION

INJECTABLE; INJECTION NONE HAEMONETICS CORPORATION

N980123

Mar 03, 2000

ANTICOAGULANT SODIUM CITRATE SOLUTION

INJECTABLE; INJECTION TRICITRASOL CYTOSOL LABORATORIES INC

N010409

Jul 10, 2003

ANTICOAGULANT SODIUM CITRATE SOLUTION USP

INJECTABLE; INJECTION NONE FENWAL INC FRESENIUS MEDICAL CARE NORTH AMERICA TERUMO MEDICAL CORP

N770923 N160702 N781214

Jan 20, 1978 Dec 28, 1970 Feb 08, 1980

DEXTRAN 1 IN SODIUM CHLORIDE 0.6%

INJECTABLE; INJECTION PROMIT MEDA AB

N830715

Oct 30, 1984

DEXTRAN 40, 10% IN DEXTROSE 5%

INJECTABLE; INJECTION GENTRAN 40 BAXTER HLTHCARE CORP 10GM/100ML;5GM/100ML LMD IN PLASTIC CONTAINER HOSPIRA INC 10GM/100ML;5GM/100ML NONE B BRAUN MEDICAL INC 10GM/100ML;5GM/100ML HOSPIRA INC 10GM/100ML;5GM/100ML MEDA AB 10GM/100ML;5GM/100ML MILES INC 10GM/100ML;5GM/100ML PHARMACHEM CORP 10GM/100ML;5GM/100ML

N840619 A720563 N160767 N160375 N140716 N160653 N160836 ANDA

Feb 22, 1985 Oct 30, 1992 Apr Jul Jan Sep Nov 06, 25, 18, 23, 14, 1970 1967 1967 1969 1972

DEXTRAN 40, 10% IN SODIUM CHLORIDE 0.9%

INJECTABLE; INJECTION GENTRAN 40 BAXTER HLTHCARE CORP 10GM/100ML;0.9GM/100ML LMD IN PLASTIC CONTAINER HOSPIRA INC 10GM/100ML;0.9GM/100ML NONE B BRAUN MEDICAL INC 10GM/100ML;0.9GM/100ML HOSPIRA INC 10GM/100ML;0.9GM/100ML MEDA AB 10GM/100ML;0.9GM/100ML MILES INC 10GM/100ML;0.9GM/100ML PHARMACHEM CORP 10GM/100ML;0.9GM/100ML

N840620 A720562 N160767 N160375 N140716 N160653 N160836 ANDA

Feb 22, 1985 Oct 30, 1992 Apr Jul Jan Sep Nov 06, 25, 18, 23, 14, 1970 1967 1967 1969 1972

DEXTRAN 40, 10% W/V DEXTRAN 40 IN 0.8% NACL 500 ML PVC BAGS
INJECTABLE; INJECTION RHEOMACRODEX MEDA AB

N830527

Mar 27, 1985

32nd EDITION - 2012- APPROVED DRUG PRODUCT LIST

5 - 4 of 5

DRUG PRODUCTS WITH APPROVAL UNDER SECTION 505 OF THE ACT

ADMINISTERED BY THE CENTER FOR BIOLOGICS EVALUATION AND RESEARCH LIST

DEXTRAN 40, 10% W/V DEXTRAN 40 IN 5% DEXTROSE 500 ML PVC BAGS

INJECTABLE; INJECTION RHEOMACRODEX MEDA AB

N830627

Mar 27, 1985

DEXTRAN 70, 6% IN DEXTROSE 5%

INJECTABLE; INJECTION MACRODEX MEDA AB

6GM/100ML;5GM/100ML

N060826

Jun 08, 1954

DEXTRAN 70, 6% IN SODIUM CHLORIDE 0.9%

INJECTABLE; INJECTION GENTRAIN 70 BAXTER HLTHCARE CORP MACRODEX MEDA AB NONE B BRAUN MEDICAL INC MILES INC

N160607 6GM/100ML;5GM/100ML 6GM/100ML;0.9 GM/100ML 6GM/100ML;0.9 GM/100ML N060826 N090024 N080716

Jan 26, 1970 Jun 08, 1954 Aug 18, 1969 Mar 13, 1953

DEXTRAN 70, 6% W/V DEXTRAN 70 IN 0.9% NACL IN 500 ML PVC BAGS

INJECTABLE; INJECTION MACRODEX MEDA AB

N830613

Mar 27, 1985

DEXTRAN 70, 6% W/V DEXTRAN 70 IN 5% DEXTROSE

INJECTABLE; INJECTION MACRODEX MEDA AB

N830629

Mar 27, 1985

DEXTRAN 75, 6% IN SODIUM CHLORIDE 0.9%

INJECTABLE; INJECTION NONE PHARMACHEM CORP

6GM/100ML;0.9GM/100ML 6GM/100ML;0.9GM/100ML

N080564 N160759

Sep 19, 1952 Aug 19, 1970

HETASTARCH 6% IN LACTATED ELECTROLYTE INJECTION

INJECTABLE; INJECTION HEXTEND BIOTIME INC

6GM/100ML

N200952

Mar 31, 1999

HETASTARCH 6% IN SODIUM CHLORIDE 0.9%

INJECTABLE; INJECTION 6% HETASTARCH IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HOSPIRA INC 6GM/100ML;0.9GM/100ML HESPAN B BRAUN MEDICAL INC 6GM/100ML;0.9GM/100ML HESPAN IN PLASTIC CONTAINER B BRAUN MEDICAL INC 6GM/100ML;0.9GM/100ML NONE B BRAUN MEDICAL INC 6GM/100ML;0.9GM/100ML TEVA PARENTERAL 6GM/100ML;0.9GM/100ML MEDICINES INC

A740193 N160889 N890105 A740283 A740592

ANDA

Jan 30, 1995 Jul 17, 1972 Apr 04, 1991

ANDA ANDA

Oct 21, 1998 Nov 12, 1998

HETASTARCH 6% IN SODIUM CHLORIDE 0.9% NACL 500 ML GLASS BOTTLES

INJECTABLE; INJECTION NONE HOSPIRA INC

6GM/100ML;0.9 GM/100ML

A720746

ANDA

Feb 07, 1996

32nd EDITION - 2012- APPROVED DRUG PRODUCT LIST

5 - 5 of 5

DRUG PRODUCTS WITH APPROVAL UNDER SECTION 505 OF THE ACT

ADMINISTERED BY THE CENTER FOR BIOLOGICS EVALUATION AND RESEARCH LIST

HYDROXYETHYL STARCH 130/0.4 IN 6% SODIUM CHLORIDE 0.9%

INJECTABLE; INJECTION VOLUVEN FRESENIUS KABI DEUTSCHLAND GMBH

6GM/100ML;0.9GM/100ML

N070012

NDA

Dec 27, 2007

PENTASTARCH 10% IN SODIUM CHLORIDE 0.9%

INJECTABLE; PENTASPAN B BRAUN PENTASPAN B BRAUN INJECTION MEDICAL INC 10GM/100ML;0.9GM/100ML IN PLASTIC CONTAINER MEDICAL INC 10GM/100ML;0.9GM/100ML N841207 N890104 May 19, 1987 Apr 04, 1991

PERFLUORODECALIN; PERFLUOROTRI-N-PROPYLAMINE
INJECTABLE; INJECTION FLUOSOL ALPHA THERAPEUTIC CORP

17.5GM/100ML;7.5GM/100ML

N860909

Dec 26, 1989

RED BLOOD CELL PROCESSING SOLUTION

INJECTABLE; INJECTION REJUVESOL CITRA LABS LLC

N950522

Feb 26, 1997

SODIUM CHLORIDE; SODIUM ACETATE; SODIUM CITRATE DIHYDRATE; SODIUM PHOSPHATE, DIABASIC ANHYDROUS; SODIUM PHOSPHATE MONOBASIC, MONOHYDRATE
INJECTABLE; INJECTION INTERSOL SOLUTION FENWAL INC.

2.26G/500ML; 2.21G/500ML; 1.59G/500ML; 1.53G/500ML; 0.465G/500ML

N080041

NDA

Dec 09, 2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

ABARELIX
INJECTABLE; INTRAMUSCULAR PLENAXIS SPECIALITY EUROPEAN 100MG/VIAL

6 - 1 (of 346)

N021320

001

Nov 25, 2003

ACETAMINOPHEN
INJECTABLE; INJECTION INJECTAPAP ORTHO MCNEIL PHARM SUPPOSITORY; RECTAL ACEPHEN G AND W LABS ACETAMINOPHEN ABLE

100MG/ML

N017785

001

Mar 07, 1986

120MG 120MG 325MG 650MG 120MG 650MG

A072218 A073106 A073107 A073108 A071010 A071011 N017756 N017756

001 001 001 001 001 001 002 001

Mar 27, 1992 Feb Feb Feb May May 27, 27, 27, 12, 12, 1995 1995 1995 1987 1987

ROXANE TYLENOL MCNEIL CONS

120MG 650MG TABLET, EXTENDED RELEASE; ORAL ACETAMINOPHEN RANBAXY 650MG

A090205

001

Nov 18, 2009

ACETAMINOPHEN; ASPIRIN; CODEINE PHOSPHATE

CAPSULE; ORAL ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE MIKART 150MG;180MG;15MG 150MG;180MG;30MG 150MG;180MG;60MG CODEINE, ASPIRIN, APAP FORMULA NO. 2 SCHERER LABS 150MG;180MG;15MG CODEINE, ASPIRIN, APAP FORMULA NO. 3 SCHERER LABS 150MG;180MG;30MG CODEINE, ASPIRIN, APAP FORMULA NO. 4 SCHERER LABS 150MG;180MG;60MG

A081095 A081096 A081097 A085640 A085639 A085638

001 001 001 001 001 001

Oct 26, 1990 Oct 26, 1990 Oct 26, 1990

ACETAMINOPHEN; BUTALBITAL
CAPSULE; ORAL BANCAP FOREST PHARMS 325MG;50MG BUCET MALLINCKRODT 650MG;50MG TENCON MALLINCKRODT 650MG;50MG TRIAPRIN DUNHALL 325MG;50MG TABLET; ORAL BUTALBITAL AND ACETAMINOPHEN HALSEY 325MG;50MG WATSON LABS 325MG;50MG SEDAPAP MAYRAND 650MG;50MG

A088889 A088991 A089405 A089268

001 001 001 001

Jan 16, 1986 Jun 28, 1985 May 15, 1990 Jul 02, 1987

A089568 A087550 A088944

001 001 001

Oct 05, 1988 Oct 19, 1984 Oct 17, 1985

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

CAPSULE; ORAL ANOQUAN SHIRE 325MG;50MG;40MG BUTALBITAL, ACETAMINOPHEN AND CAFFEINE GRAHAM DM 325MG;50MG;40MG 325MG;50MG;40MG 325MG;50MG;40MG

A087628 A088743 A088765 A089067

001 001 001 001

Oct 01, 1986 Jul 18, 1985 Mar 27, 1985 Apr 19, 1985

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

ACETAMINOPHEN; BUTALBITAL; CAFFEINE
CAPSULE; ORAL BUTALBITAL, ACETAMINOPHEN AND CAFFEINE MALLINCKRODT 325MG;50MG;40MG BUTALIBITAL, ACETAMINOPHEN AND CAFFEINE GILBERT LABS 325MG;50MG;40MG FEMCET MALLINCKRODT 325MG;50MG;40MG MEDIGESIC PLUS US CHEM 325MG;50MG;40MG TRIAD MALLINCKRODT 325MG;50MG;40MG TABLET; ORAL BUTALBITAL, ACETAMINOPHEN AND CAFFEINE ABLE 325MG;50MG;40MG 500MG;50MG;40MG GILBERT LABS 325MG;50MG;40MG MUTUAL PHARM 325MG;50MG;40MG WATSON LABS 325MG;50MG;40MG ESGIC FOREST PHARMS 325MG;50MG;40MG

6 - 2 (of 346)

A088758 A088825 A089102 A089115 A089023

001 001 001 001 001

Mar 27, 1985 Dec 05, 1984 Jun 19, 1985 Jan 14, 1986 Jun 19, 1985

A040390 A040394 A087629 A040601 A089536 A089660

001 001 001 001 001 001

Jul Jul Nov Jul Feb

23, 23, 13, 29, 16,

2001 2001 1984 2005 1988

Dec 23, 1988

ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE

CAPSULE; ORAL BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE ABLE 325MG;50MG;40MG;30MG

A076528

001

Aug 21, 2003

ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE

CAPSULE; ORAL DHC PLUS PHARM RES ASSOC 356.4MG;30MG;16MG SYNALGOS-DC-A LEITNER PHARMS 356.4MG;30MG;16MG TABLET; ORAL ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE WEST-WARD PHARM CORP 712.8MG;60MG;32MG

A088584 A089166

001 001

Mar 04, 1986 May 14, 1986

A040637

001

Sep 22, 2006

ACETAMINOPHEN; CODEINE PHOSPHATE

CAPSULE; ORAL ACETAMINOPHEN AND CODEINE PHOSPHATE TEVA 300MG;15MG 300MG;30MG 300MG;60MG PHENAPHEN W/ CODEINE NO. 2 ROBINS AH 325MG;15MG PHENAPHEN W/ CODEINE NO. 3 ROBINS AH 325MG;30MG PHENAPHEN W/ CODEINE NO. 4 ROBINS AH 325MG;60MG PROVAL #3 SOLVAY 325MG;30MG TYLENOL W/ CODEINE NO. 3 ORTHO MCNEIL PHARM 300MG;30MG TYLENOL W/ CODEINE NO. 4 ORTHO MCNEIL PHARM 300MG;60MG SOLUTION; ORAL ACETAMINOPHEN AND CODEINE PHOSPHATE ACTAVIS MID ATLANTIC 120MG/5ML;12MG/5ML CLONMEL 120MG/5ML;12MG/5ML ROXANE 120MG/5ML;12MG/5ML TYLENOL W/ CODEINE ORTHO MCNEIL PHARM 120MG/5ML;12MG/5ML

A088537 A088324 A088599 A084444 A084445 A084446 A085685 A087422 A087421

001 001 001 001 001 001 001 001 001

Jun 04, 1984 Dec 29, 1983 Jun 01, 1984

A085861 A040098 A086366 A085057

001 001 001 001

Sep 20, 1996

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

ACETAMINOPHEN; CODEINE PHOSPHATE
SUSPENSION; ORAL CAPITAL AND CODEINE ACTAVIS MID ATLANTIC 120MG/5ML;12MG/5ML TABLET; ORAL ACETAMINOPHEN AND CODEINE PHOSPHATE ABLE 300MG;30MG 300MG;60MG AM THERAP 300MG;15MG 300MG;15MG 300MG;30MG 300MG;30MG 300MG;60MG 300MG;60MG DURAMED PHARMS BARR 300MG;15MG 300MG;15MG 300MG;30MG 300MG;30MG 300MG;60MG 300MG;60MG EVERYLIFE 325MG;30MG HALSEY 300MG;15MG 300MG;30MG 300MG;60MG KV PHARM 300MG;30MG 300MG;60MG 325MG;15MG 325MG;45MG LEDERLE 300MG;30MG MIKART 300MG;60MG MUTUAL PHARM 300MG;15MG 300MG;15MG 300MG;30MG 300MG;30MG 300MG;60MG 300MG;60MG PURACAP PHARM 300MG;30MG PUREPAC PHARM 300MG;30MG 300MG;30MG 300MG;60MG ROXANE 300MG;15MG 300MG;30MG 300MG;60MG 500MG;15MG 500MG;30MG 500MG;60MG SANDOZ 300MG;15MG 300MG;30MG 300MG;30MG 300MG;30MG 300MG;60MG 300MG;60MG 300MG;60MG SUPERPHARM 300MG;15MG 300MG;30MG 300MG;30MG 300MG;60MG 300MG;60MG USL PHARMA 300MG;30MG 300MG;60MG VALEANT PHARM INTL 300MG;30MG VITARINE 300MG;30MG WARNER CHILCOTT 300MG;15MG

6 - 3 (of 346)

A085883

001

A040452 A040459 A089478 A089481 A089479 A089482 A089480 A089483 A040223 A088353 A040223 A088354 A040223 A088355 A085217 A083871 A083872 A086549 A085288 A085365 A085364 A085363 A087141 A089244 A085795 A089671 A085794 A089672 A087653 A089673 A087762 A086681 A089080 A086683 A084659 A084656 A084667 A089511 A089512 A089513 A087433 A081250 A085291 A085917 A081249 A085964 A087423 A089183 A089184 A089253 A089185 A089254 A087919 A087920 A085896 A085676 A085992

001 001 001 001 001 001 001 001 001 001 002 001 003 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 002 001 001 001 001 001 001 001 001 001 001 001 001 001 001

Aug Aug Mar Mar Mar Mar Mar Mar Nov Feb Nov Feb Nov Feb

01, 01, 03, 03, 03, 03, 03, 03, 18, 06, 18, 06, 18, 06,

2002 2002 1987 1987 1987 1987 1987 1987 1997 1984 1997 1984 1997 1984

Feb 25, 1986 Feb 10, 1988 Feb Apr Feb Dec 10, 13, 10, 10, 1988 1982 1988 1982

Jul 17, 1986

Apr 25, 1989 Apr 25, 1989 Apr 25, 1989 Jul 16, 1992

Jul 16, 1992

Oct Oct May Oct May Jun Jun

18, 18, 19, 18, 19, 22, 22,

1985 1985 1986 1985 1986 1982 1982

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

ACETAMINOPHEN; CODEINE PHOSPHATE
TABLET; ORAL ACETAMINOPHEN AND CODEINE PHOSPHATE WARNER CHILCOTT 300MG;30MG 300MG;60MG WATSON LABS 300MG;15MG 300MG;15MG 300MG;30MG 300MG;30MG 300MG;60MG 300MG;60MG WATSON LABS FLORIDA 300MG;15MG 300MG;30MG 300MG;60MG WHITEWORTH TOWN PLSN 300MG;30MG 300MG;60MG CAPITAL AND CODEINE CARNRICK 325MG;30MG CODRIX WATSON LABS FLORIDA 500MG;15MG 500MG;30MG 500MG;60MG EMPRACET W/ CODEINE PHOSPHATE #3 GLAXOSMITHKLINE 300MG;30MG EMPRACET W/ CODEINE PHOSPHATE #4 GLAXOSMITHKLINE 300MG;60MG PAPA-DEINE #3 VANGARD 300MG;30MG PAPA-DEINE #4 VANGARD 300MG;60MG PHENAPHEN-650 W/ CODEINE ROBINS AH 650MG;30MG TYLENOL W/ CODEINE ORTHO MCNEIL PHARM 325MG;7.5MG 325MG;15MG 325MG;30MG 325MG;60MG TYLENOL W/ CODEINE NO. 1 JANSSEN PHARMS 300MG;7.5MG TYLENOL W/ CODEINE NO. 2 JANSSEN PHARMS 300MG;15MG

6 - 4 (of 346)

A085218 A087306 A087277 A089997 A087276 A089998 A087275 A089999 A040443 A040443 A040443 A084360 A085607 A083643 A040447 A040441 A040488 A083951 A083951 A088037 A088715 A085856 A085056 A085056 A085056 A085056 A085055 A085055

002 001 001 001 001 001 001 001 001 002 003 001 001 001 001 001 001 001 002 001 001 001 001 002 003 004 001 002

May Dec May Dec May Dec Jan Jan Jan

26, 28, 26, 28, 26, 28, 22, 22, 22,

1982 1994 1982 1994 1982 1994 2003 2003 2003

Feb 26, 2003 Mar 27, 2003 Mar 28, 2003

Mar 20, 1984 Mar 20, 1984

ACETAMINOPHEN; HYDROCODONE BITARTRATE

CAPSULE; ORAL ACETAMINOPHEN AND HYDROCODONE BITARTRATE CENT PHARMS 500MG;5MG ALLAY IVAX PHARMS 500MG;5MG BANCAP HC FOREST PHARMS 500MG;5MG CO-GESIC CENT PHARMS 500MG;5MG HYDROCODONE BITARTRATE AND ACETAMINOPHEN MALLINCKRODT 500MG;5MG 500MG;5MG MIKART 500MG;5MG 500MG;5MG 500MG;5MG LORCET-HD MALLINCKRODT 500MG;5MG SOLUTION; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN MALLINCKRODT INC 500MG/15ML;10MG/15ML

A088898 A089907 A087961 A089360 A088956 A089006 A081068 A081069 A081070 A087336

001 001 001 001 001 001 001 001 001 001

Mar 27, 1985 Jan 13, 1989 Mar 17, 1983 Mar 02, 1988 Jul Aug Nov Nov Nov 19, 09, 30, 30, 30, 1985 1985 1989 1989 1989

Jul 08, 1982

A040508

001

Aug 29, 2003

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

ACETAMINOPHEN; HYDROCODONE BITARTRATE
SOLUTION; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN MIKART 500MG/15ML;5MG/15ML 500MG/15ML;5MG/15ML TABLET; ORAL DURADYNE DHC FOREST PHARMS 500MG;5MG HYDROCODONE BITARTRATE AND ACETAMINOPHEN ABLE 325MG;5MG 325MG;7.5MG 325MG;10MG 500MG;5MG 500MG;7.5MG 500MG;10MG 650MG;7.5MG 650MG;10MG 750MG;7.5MG BARR 500MG;2.5MG 500MG;5MG 500MG;5MG 500MG;7.5MG 500MG;10MG 650MG;7.5MG 650MG;10MG 750MG;7.5MG ENDO PHARMS 500MG;5MG 500MG;7.5MG 650MG;7.5MG 650MG;10MG 750MG;7.5MG HALSEY 500MG;5MG IVAX PHARMS 500MG;5MG MIKART 500MG;5MG 500MG;5MG MUTUAL PHARM 500MG;5MG 650MG;7.5MG 650MG;10MG 750MG;7.5MG RANBAXY 500MG;5MG 500MG;10MG RANBAXY LABS LTD 325MG;10MG 750MG;7.5MG SANDOZ 500MG;5MG 750MG;7.5MG UCB INC 500MG;10MG 650MG;7.5MG USL PHARMA 500MG;5MG 500MG;5MG VINTAGE PHARMS 500MG;5MG WATSON LABS 325MG;7.5MG 325MG;10MG 500MG;2.5MG 500MG;5MG 500MG;7.5MG 650MG;7.5MG 650MG;10MG 750MG;7.5MG WATSON LABS FLORIDA 500MG;5MG 750MG;7.5MG HY-PHEN ASCHER 500MG;5MG

6 - 5 (of 346)

A081226 A089557

001 001

Oct 27, 1992 Apr 29, 1992

A087809 A040478 A040464 A040464 A040477 A040490 A040473 A040474 A040476 A040469 A040307 A040308 A088577 A040307 A040309 A040307 A040307 A040308 A040281 A040280 A040280 A040280 A040281 A089554 A089696 A089271 A089697 A040236 A040240 A040240 A040236 A040825 A040824 A040826 A040822 A040149 A040149 A040210 A040134 A089290 A089291 A089831 A040248 A040248 A040123 A040122 A040123 A040123 A040123 A040122 A040493 A040494 A087677

001 001 001 002 001 001 001 001 001 001 001 001 001 002 001 003 004 002 001 001 002 003 002 001 001 001 001 001 002 001 002 001 001 001 001 001 002 001 001 001 001 001 001 002 003 001 004 001 002 002 001 001 001

Mar 17, 1983 Nov Oct Oct Nov May Nov Jan Oct Oct Jul Jul Dec Jul Jul Jul Jul Jul Sep Sep Sep Sep Sep Jun Apr Jul Jan Sep Nov Nov Sep Aug Aug Aug Aug Jan Jan Aug Nov May May Sep Apr Apr Mar Mar Mar Mar Mar Mar May May 08, 23, 23, 06, 21, 06, 02, 23, 25, 26, 26, 21, 26, 26, 26, 26, 26, 30, 30, 30, 30, 30, 12, 21, 16, 28, 25, 26, 26, 25, 16, 16, 16, 16, 27, 27, 13, 21, 29, 29, 07, 28, 28, 04, 04, 04, 04, 04, 04, 28, 28, 2002 2002 2002 2002 2003 2002 2003 2002 2002 2000 2000 1984 2000 2000 2000 2000 2000 1998 1998 1998 1998 1998 1987 1988 1986 1992 1997 1997 1997 1997 2007 2007 2007 2007 1997 1997 1997 1996 1987 1987 1988 2000 2000 1996 1996 1996 1996 1996 1996 2003 2003

May 03, 1982

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

ACETAMINOPHEN; HYDROCODONE BITARTRATE
TABLET; ORAL NORCET ABANA TYCOLET ORTHO MCNEIL PHARM VICODIN ABBOTT

6 - 6 (of 346)

500MG;5MG 500MG;5MG 500MG;5MG

A088871 A089385 A085667

001 001 001

May 15, 1986 Aug 27, 1986

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

CAPSULE; ORAL OXYCODONE AND ACETAMINOPHEN ACTAVIS TOTOWA 500MG;5MG BARR 500MG;5MG ENDO PHARMS 500MG;5MG HALSEY 500MG;5MG MUTUAL PHARM 500MG;5MG TYLOX-325 ORTHO MCNEIL PHARM 325MG;5MG SOLUTION; ORAL OXYCODONE AND ACETAMINOPHEN MALLINCKRODT INC 325MG/5ML;5MG/5ML TABLET; ORAL OXYCODONE 2.5/APAP 500 BRISTOL MYERS SQUIBB 500MG;2.5MG OXYCODONE 5/APAP 500 BRISTOL MYERS SQUIBB 500MG;5MG OXYCODONE AND ACETAMINOPHEN ACTAVIS TOTOWA 325MG;5MG BARR 325MG;5MG DURAMED PHARMS BARR 325MG;5MG PERCOCET ENDO PHARMS 325MG;5MG

A040199 A040304 A040303 A089994 A040219 A088246

001 001 001 001 001 001

Dec Oct Dec May Jan

30, 02, 30, 04, 22,

1998 2000 1999 1989 1998

Nov 08, 1984

A040680

001

Sep 29, 2006

A085910 A085911 A040203 A087406 A040272 A085106

001 001 001 001 001 002 Mar 15, 1999 Jun 30, 1998

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE

CAPSULE; ORAL TYLOX ORTHO MCNEIL PHARM

500MG;4.5MG;0.38MG

A085375

001

ACETAMINOPHEN; PENTAZOCINE HYDROCHLORIDE

TABLET; ORAL TALACEN SANOFI AVENTIS US

650MG;EQ 25MG BASE

N018458

001

Sep 23, 1982

ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE

TABLET; ORAL DARVOCET AAIPHARMA LLC 325MG;32.5MG DOLENE AP-65 LEDERLE 650MG;65MG PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN MYLAN 325MG;32MG 650MG;65MG SANDOZ 650MG;65MG VINTAGE PHARMS 650MG;65MG WATSON LABS 650MG;65MG WYGESIC LEITNER PHARMS 650MG;65MG

N016844 A085100 A083689 A083978 A089959 A040507 A040139 A084999

001 001 001 001 001 001 001 001

Jul 18, 1989 Jul 30, 2003 Dec 16, 1996

ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE

TABLET; ORAL DARVOCET A500 XANODYNE PHARM

500MG;100MG

A076429

001

Sep 10, 2003

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE
TABLET; ORAL DARVOCET-N 100 XANODYNE PHARM 650MG;100MG DARVOCET-N 50 XANODYNE PHARM 325MG;50MG PROPACET 100 TEVA 650MG;100MG PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN ABLE 650MG;100MG ACTAVIS ELIZABETH 650MG;100MG CORNERSTONE 325MG;100MG 500MG;100MG HALSEY 325MG;50MG 650MG;100MG IVAX SUB TEVA PHARMS 650MG;100MG MALLINCKRODT 650MG;100MG MIRROR PHARMS 650MG;100MG MUTUAL PHARM 325MG;50MG 650MG;100MG 650MG;100MG 650MG;100MG 650MG;100MG MYLAN 650MG;100MG MYLAN PHARMS INC 650MG;100MG SANDOZ 650MG;100MG SUPERPHARM 650MG;100MG TEVA 650MG;100MG 650MG;100MG VINTAGE PHARMS 325MG;50MG 650MG;100MG WATSON LABS 325MG;50MG 650MG;100MG WATSON LABS FLORIDA 500MG;100MG 650MG;100MG WOCKHARDT LTD 325MG;50MG 650MG;100MG

6 - 7 (of 346)

N017122 N017122 A070107 A075838 A070910 A076743 A076750 A072105 A072106 A070146 A075738 A077821 A070115 A070116 A070615 A070771 A070775 A072195 A070145 A070443 A071319 A070732 A074119 A074843 A074843 A070398 A070399 A077196 A076609 A077677 A077677

002 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 002 001 001 001 001 001 001 002 Jun 12, 1985 Jul Jan May Jun May May Aug Feb Feb Jun Jun Mar Mar Mar Feb Jun Jan Jan Jan Dec Feb Feb Dec Dec Jun Nov Mar Mar 11, 02, 07, 28, 13, 13, 02, 02, 11, 12, 12, 21, 21, 21, 16, 12, 23, 06, 03, 19, 15, 12, 18, 18, 28, 16, 16, 16, 2001 1987 2004 2004 1988 1988 1985 2001 2008 1985 1985 1986 1986 1986 1988 1985 1986 1987 1986 1994 2001 1997 1986 1986 2005 2004 2007 2007

ACETAZOLAMIDE
TABLET; ORAL ACETAZOLAMIDE ALRA ASCOT MUTUAL PHARM VANGARD WATSON LABS DIAMOX DURAMED PHARMS BARR

250MG 250MG 250MG 250MG 250MG 125MG 250MG

A083320 A087686 A089753 A087654 A084498 N008943 N008943

001 001 001 001 002 001 002

Oct 20, 1982 Jun 22, 1988 Feb 05, 1982

ACETAZOLAMIDE SODIUM
INJECTABLE; INJECTION ACETAZOLAMIDE SODIUM HOSPIRA

EQ 500MG BASE/VIAL

A040108

001

Oct 30, 1995

ACETIC ACID, GLACIAL

SOLUTION/DROPS; OTIC ACETASOL ACTAVIS MID ATLANTIC ACETIC ACID KV PHARM ORLEX WARNER CHILCOTT

2% 2% 2%

A087146 A085493 A086845

001 001 001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

ACETIC ACID, GLACIAL; ALUMINUM ACETATE
SOLUTION/DROPS; OTIC BOROFAIR PHARMAFAIR DOMEBORO BAYER PHARMS

6 - 8 (of 346)

2%;0.79% 2%;0.79%

A088606 A084476

001 001

Aug 21, 1985

ACETIC ACID, GLACIAL; DESONIDE

SOLUTION/DROPS; OTIC TRIDESILON BAYER PHARMS

2%;0.05%

N017914

001

ACETIC ACID, GLACIAL; HYDROCORTISONE

SOLUTION/DROPS; OTIC ACETIC ACID W/ HYDROCORTISONE KV PHARM 2%;1% HYDROCORTISONE AND ACETIC ACID BAUSCH AND LOMB 2%;1% WOCKHARDT 2%;1% ORLEX HC WARNER CHILCOTT 2%;1%

A085492 A040097 A040168 A086844

001 001 001 001 Oct 31, 1994 Aug 30, 1996

ACETIC ACID, GLACIAL; HYDROCORTISONE; NEOMYCIN SULFATE

SUSPENSION/DROPS; OTIC NEO-CORT-DOME BAYER PHARMS

2%;1%;EQ 0.35% BASE

N050238

001

ACETOHEXAMIDE
TABLET; ORAL ACETOHEXAMIDE BARR USL PHARMA DYMELOR LILLY

250MG 500MG 250MG 500MG 250MG 500MG

A070869 A070870 A070753 A070754 N013378 N013378

001 001 001 001 002 001

Feb Feb Nov Nov

09, 09, 03, 03,

1987 1987 1986 1986

ACETOPHENAZINE MALEATE
TABLET; ORAL TINDAL SCHERING

20MG

N012254

002

ACETRIZOATE SODIUM
SOLUTION; INTRAUTERINE SALPIX ORTHO MCNEIL PHARM

53%

N009008

001

ACETYLCHOLINE CHLORIDE
FOR SOLUTION; OPHTHALMIC MIOCHOL NOVARTIS

20MG/VIAL

N016211

001

ACETYLCYSTEINE
SOLUTION; INHALATION, ORAL ACETYLCYSTEINE HOSPIRA 10% 20% ROXANE 10% 20% MUCOMYST APOTHECON 10% 20%

A071364 A071365 A072621 A072622 N013601 N013601

001 001 001 001 002 001

May May Sep Sep

01, 01, 30, 30,

1989 1989 1992 1992

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

ACETYLCYSTEINE
SOLUTION; INHALATION, ORAL MUCOSIL-10 DEY 10% MUCOSIL-20 DEY 20%

6 - 9 (of 346)

A070575 A070576

001 001

Oct 14, 1986 Oct 14, 1986

ACETYLCYSTEINE; ISOPROTERENOL HYDROCHLORIDE

SOLUTION; INHALATION MUCOMYST W/ ISOPROTERENOL MEAD JOHNSON 10%;0.05%

N017366

001

ACETYLDIGITOXIN
TABLET; ORAL ACYLANID NOVARTIS

0.1MG

N009436

001

ACRISORCIN
CREAM; TOPICAL AKRINOL SCHERING

2MG/GM

N012470

001

ACYCLOVIR
CAPSULE; ORAL ACYCLOVIR ACTAVIS ELIZABETH BELCHER PHARMS DAVA PHARMS INC IVAX SUB TEVA PHARMS LEK PHARM ROXANE TEVA TEVA PHARMS TABLET; ORAL ACYCLOVIR ACTAVIS ELIZABETH BELCHER PHARMS DAVA PHARMS INC IVAX SUB TEVA PHARMS LEK PHARM TEVA TEVA PHARMS

200MG 200MG 200MG 200MG 200MG 200MG 200MG 200MG

A074906 A074889 A074872 A074674 A074750 A074570 A074828 A074914

001 001 001 001 001 002 001 001

Aug Oct Apr Apr Apr Apr Apr Nov

26, 31, 22, 22, 22, 22, 22, 26,

1997 1997 1997 1997 1997 1997 1997 1997

400MG 800MG 400MG 800MG 400MG 800MG 400MG 800MG 400MG 800MG 200MG 400MG 800MG

A074870 A074870 A074891 A074891 A074834 A074834 A074836 A074836 A074658 A074658 A074556 A075021 A075021

001 002 001 002 001 002 001 002 001 002 001 001 002

Jun Jun Oct Oct Apr Apr Apr Apr Apr Apr Apr Mar Mar

05, 05, 31, 31, 24, 24, 22, 22, 22, 22, 22, 18, 18,

1997 1997 1997 1997 1997 1997 1997 1997 1997 1997 1997 1998 1998

ACYCLOVIR SODIUM
INJECTABLE; INJECTION ACYCLOVIR ABBOTT ACYCLOVIR SODIUM APOTHECON HOSPIRA

EQ 50MG BASE/ML EQ EQ EQ EQ EQ EQ EQ EQ EQ 500MG BASE/VIAL 1GM BASE/VIAL 25MG BASE/ML 50MG BASE/ML 500MG BASE/VIAL 500MG BASE/VIAL 1GM BASE/VIAL 1GM BASE/VIAL 50MG BASE/ML

A075114 A074897 A074897 A074720 A075065 A074663 A074758 A074663 A074758 A075627

001 001 002 001 001 001 001 002 002 001

Jul 26, 1999 Feb Feb Apr Feb Apr Apr Apr Apr Mar 27, 27, 22, 25, 22, 22, 22, 22, 28, 1998 1998 1997 1999 1997 1997 1997 1997 2001

TEVA PARENTERAL

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

ACYCLOVIR SODIUM
INJECTABLE; INJECTION ACYCLOVIR SODIUM TEVA PARENTERAL ZOVIRAX GLAXOSMITHKLINE

6 - 10 (of 346)

EQ 500MG BASE/VIAL EQ 1GM BASE/VIAL EQ 250MG BASE/VIAL EQ 500MG BASE/VIAL EQ 1GM BASE/VIAL

A074969 A074969 N018603 N018603 N018603

001 002 003 001 002

Aug 26, 1997 Aug 26, 1997 Aug 30, 1983 Oct 22, 1982 Jun 29, 1989

ADAPALENE
SOLUTION; TOPICAL DIFFERIN GALDERMA LABS LP

0.1%

N020338

001

May 31, 1996

ADENOSINE
INJECTABLE; INJECTION ADENOSINE BAXTER HLTHCARE

3MG/ML

A076501

001

Jun 16, 2004

ALATROFLOXACIN MESYLATE
INJECTABLE; INJECTION TROVAN PRESERVATIVE FREE PFIZER EQ 200MG BASE/VIAL EQ 300MG BASE/VIAL

N020760 N020760

001 002

Dec 18, 1997 Dec 18, 1997

ALBUMIN CHROMATED CR-51 SERUM

INJECTABLE; INJECTION CHROMALBIN ISO TEX

100uCi/VIAL 250uCi/VIAL 500uCi/VIAL

N017835 N017835 N017835

001 002 003

ALBUMIN IODINATED I-125 SERUM

INJECTABLE; INJECTION RADIO-IODINATED (I 125) SERUM ALBUMIN (HUMAN) BAYER PHARMS 2.5uCi/AMP RADIOIODINATED SERUM ALBUMIN (HUMAN) IHSA I 125 MALLINCKRODT 6.67uCi/ML 10uCi/ML 100uCi/ML

N017846 N017844 N017844 N017844

001 003 001 002

ALBUMIN IODINATED I-131 SERUM

INJECTABLE; INJECTION MEGATOPE ISO TEX

2mCi/VIAL 5uCi/AMP 20uCi/AMP

N017837 N017837 N017837

003 004 005

ALBUTEROL
AEROSOL, METERED; INHALATION ALBUTEROL ARMSTRONG PHARMS 0.09MG/INH GENPHARM 0.09MG/INH IVAX SUB TEVA PHARMS 0.09MG/INH PLIVA 0.09MG/INH PROVENTIL SCHERING 0.09MG/INH VENTOLIN GLAXOSMITHKLINE 0.09MG/INH

A072273 A073045 A073272 A074072 N017559 N018473

001 001 001 001 001 001

Aug Aug Dec Aug

14, 19, 28, 01,

1996 1997 1995 1996

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

ALBUTEROL SULFATE
CAPSULE; INHALATION VENTOLIN ROTACAPS GLAXOSMITHKLINE SOLUTION; INHALATION ALBUTEROL SULFATE ACTAVIS MID ATLANTIC BAUSCH AND LOMB COPLEY PHARM ROXANE PROVENTIL SCHERING VENTOLIN GLAXOSMITHKLINE SYRUP; ORAL ALBUTEROL SULFATE ACTAVIS MID ATLANTIC MOVA WATSON LABS PROVENTIL SCHERING VENTOLIN GLAXOSMITHKLINE TABLET; ORAL ALBUTEROL SULFATE AM THERAP COPLEY PHARM DAVA PHARMS INC PLIVA SANDOZ TEVA

6 - 11 (of 346)

EQ 0.2MG BASE

N019489

001

May 04, 1988

EQ EQ EQ EQ EQ

0.083% BASE 0.083% BASE 0.083% BASE 0.5% BASE 0.083% BASE

A073533 A075358 A073495 A073307 A075129 N019243 N019243 N019773 N019269

001 001 001 001 001 002 001 001 002

Sep Mar May Nov Feb

26, 29, 28, 27, 13,

1995 2000 1993 1991 2001

EQ 0.083% BASE EQ 0.5% BASE EQ 0.083% BASE EQ 0.5% BASE

Jan 14, 1987 Jan 14, 1987 Apr 23, 1992 Jan 16, 1987

EQ 2MG BASE/5ML EQ 2MG BASE/5ML EQ 2MG BASE/5ML EQ 2MG BASE/5ML EQ 2MG BASE/5ML

A075262 A074302 A073165 N018062 N019621

001 001 001 001 001

Mar 30, 1999 Sep 30, 1994 Apr 29, 1993 Jan 19, 1983 Jun 10, 1987

UCB INC WARNER CHILCOTT WATSON LABS

EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ

2MG 4MG 2MG 4MG 2MG 4MG 2MG 4MG 2MG 4MG 2MG 2MG 2MG 4MG 4MG 4MG 2MG 4MG 2MG 4MG 2MG 4MG 4MG

BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE

A072449 A072450 A072966 A072967 A072859 A072860 A072316 A072317 A072151 A072152 A072619 A072779 A072938 A072620 A072780 A072939 A073120 A073121 A072817 A072818 A072629 A072630 A072765 N017853 N017853 N019112 N019112

001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 002 001 002

Dec Dec Nov Nov Dec Dec Dec Dec Dec Dec Dec Jun Mar Dec Jun Mar Sep Sep Jan Jan Jan Jan Aug

05, 05, 22, 22, 20, 20, 05, 05, 05, 05, 05, 25, 30, 05, 25, 30, 29, 29, 09, 09, 31, 31, 28,

1989 1989 1991 1991 1989 1989 1989 1989 1989 1989 1989 1993 1990 1989 1993 1990 1992 1992 1990 1990 1991 1991 1991

PROVENTIL SCHERING VENTOLIN GLAXOSMITHKLINE

EQ 2MG BASE EQ 4MG BASE

May 07, 1982 May 07, 1982 Jul 10, 1986 Jul 10, 1986

EQ 2MG BASE EQ 4MG BASE TABLET, EXTENDED RELEASE; ORAL PROVENTIL SCHERING EQ 4MG BASE VOLMAX MURO EQ 4MG BASE EQ 8MG BASE

N019383 N019604 N019604

001 002 001

Jul 13, 1987 Dec 23, 1992 Dec 23, 1992

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

ALCOHOL
INJECTABLE; INJECTION ALCOHOL 5% IN DEXTROSE 5% MILES 5ML/100ML

6 - 12 (of 346)

A083483

001

ALCOHOL; DEXTROSE
INJECTABLE; INJECTION ALCOHOL 5% IN D5-W HOSPIRA 5ML/100ML;5GM/100ML ALCOHOL 5% IN DEXTROSE 5% IN WATER BAXTER HLTHCARE 5ML/100ML;5GM/100ML

A083263 A083256

001 001

ALENDRONATE SODIUM
TABLET; ORAL ALENDRONATE SODIUM SANDOZ

TEVA PHARMS

EQ EQ EQ EQ EQ EQ EQ

5MG BASE 10MG BASE 35MG BASE 40MG BASE 70MG BASE 35MG BASE 70MG BASE

A075871 A075871 A075871 A075871 A075871 A076184 A076184

001 002 004 003 005 002 001

Apr Apr Apr Apr Apr Aug Feb

22, 22, 22, 22, 22, 04, 06,

2009 2009 2009 2009 2009 2008 2008

ALGLUCERASE
INJECTABLE; INJECTION CEREDASE GENZYME

10 UNITS/ML

N020057

004

May 08, 1992

ALKAVERVIR
TABLET; ORAL VERILOID 3M

2MG 3MG

N007336 N007336

002 003

ALLOPURINOL
TABLET; ORAL ALLOPURINOL MUTUAL PHARM PURACAP PHARM PUREPAC PHARM SANDOZ SUPERPHARM WATSON LABS

100MG 300MG 100MG 300MG 100MG 300MG 100MG 300MG 100MG 300MG 100MG 100MG 300MG 300MG 100MG 300MG

A070466 A070467 A070150 A070147 A070579 A070580 A070268 A070269 A070950 A070951 N018241 N018785 N018241 N018785 N018297 N018297

001 001 001 001 001 001 001 001 001 001 001 001 002 002 001 002

Dec Dec Dec Dec Apr Apr Dec Dec Nov Nov Nov Sep Nov Sep

24, 24, 10, 10, 14, 14, 31, 31, 30, 30, 16, 28, 16, 28,

1985 1985 1985 1985 1986 1986 1985 1985 1988 1988 1984 1984 1984 1984

LOPURIN ABBOTT

ALPRAZOLAM
SOLUTION; ORAL ALPRAZOLAM ROXANE TABLET; ORAL ALPRAZOLAM IVAX SUB TEVA PHARMS

0.5MG/5ML

A074314

001

Oct 31, 1993

0.25MG 0.5MG

A074294 A074294

001 002

Jul 29, 1994 Jul 29, 1994

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

ALPRAZOLAM
TABLET; ORAL ALPRAZOLAM IVAX SUB TEVA PHARMS ROXANE

6 - 13 (of 346)

TEVA

WATSON LABS

1MG 2MG 0.25MG 0.5MG 1MG 0.25MG 0.5MG 1MG 2MG 0.25MG 0.25MG 0.5MG 0.5MG 1MG 1MG

A074294 A074294 A074199 A074199 A074199 A074085 A074085 A074085 A074085 A074456 A074479 A074456 A074479 A074456 A074479

003 004 001 002 003 001 002 003 004 001 001 002 002 003 003

Jul Jul Oct Oct Oct Feb Feb Feb Feb Aug Jan Aug Jan Aug Jan

29, 29, 19, 19, 19, 16, 16, 16, 26, 31, 21, 31, 21, 31, 21,

1994 1994 1993 1993 1993 1994 1994 1994 1996 1995 1997 1995 1997 1995 1997

ALPROSTADIL
INJECTABLE; INJECTION CAVERJECT PFIZER

0.005MG/ML 0.01MG/ML 0.02MG/ML 0.005MG/VIAL

N020755 N020755 N020755 N020649

001 002 003 001

Oct 31, 1997 Oct 01, 1997 Oct 01, 1997 Jun 12, 1997

EDEX SCHWARZ PHARMA

ALSEROXYLON
TABLET; ORAL RAUTENSIN NOVARTIS RAUWILOID 3M

2MG 2MG

N009215 N008867

001 001

ALUMINUM HYDROXIDE; MAGNESIUM TRISILICATE

TABLET, CHEWABLE; ORAL ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE PENNEX 80MG;20MG FOAMICON NOVARTIS 80MG;20MG

A089449 A072687

001 001

Nov 27, 1987 Jun 28, 1989

AMANTADINE HYDROCHLORIDE
CAPSULE; ORAL AMANTADINE HYDROCHLORIDE ACTAVIS TOTOWA 100MG WATSON LABS 100MG SYMADINE SOLVAY 100MG SYMMETREL ENDO PHARMS 100MG SYRUP; ORAL AMANTADINE HYDROCHLORIDE ACTAVIS MID ATLANTIC 50MG/5ML TEVA PHARMS 50MG/5ML SYMMETREL ENDO PHARMS 50MG/5ML TABLET; ORAL SYMMETREL ENDO PHARMS 100MG

A077659 A071382 A071000 N016020

001 001 001 001

Feb 23, 2006 Jan 21, 1987 Sep 04, 1986

A072655 A073115 N016023

001 001 002

Oct 30, 1990 Aug 23, 1991

N018101

001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

AMCINONIDE
CREAM; TOPICAL CYCLOCORT ASTELLAS LOTION; TOPICAL CYCLOCORT ASTELLAS OINTMENT; TOPICAL CYCLOCORT ASTELLAS

6 - 14 (of 346)

0.025% 0.1%

N018116 N018116

001 002

0.1%

N019729

001

Jun 13, 1988

0.1%

N018498

001

AMDINOCILLIN
INJECTABLE; INJECTION COACTIN ROCHE

250MG/VIAL 500MG/VIAL 1GM/VIAL

N050565 N050565 N050565

001 002 003

Dec 21, 1984 Dec 21, 1984 Dec 21, 1984

AMIFOSTINE
INJECTABLE; INJECTION ETHYOL MEDIMMUNE

375MG/VIAL

N020221

002

Sep 10, 1999

AMIKACIN SULFATE
INJECTABLE; INJECTION AMIKACIN SULFATE ABBOTT

EQ 250MG BASE/ML EQ 250MG BASE/ML ASTRAZENECA EQ 50MG BASE/ML EQ 250MG BASE/ML BAXTER HLTHCARE EQ 50MG BASE/ML EQ 250MG BASE/ML HOSPIRA EQ 50MG BASE/ML EQ 62.5MG BASE/ML EQ 250MG BASE/ML EQ 250MG BASE/ML EQ 250MG BASE/ML TEVA PARENTERAL EQ 50MG BASE/ML AMIKACIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HOSPIRA EQ 500MG BASE/100ML AMIKIN APOTHECON EQ 50MG BASE/ML EQ 50MG BASE/ML EQ 50MG BASE/ML EQ 250MG BASE/ML EQ 250MG BASE/ML EQ 250MG BASE/ML AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER APOTHECON EQ 5MG BASE/ML EQ 10MG BASE/ML

A063265 A063266 A063167 A063169 A063274 A063275 A063350 A063283 A063350 A064098 A064099 A064045 A064146 A062311 A062562 N050495 A062311 A062562 N050495 N050618 N050618

001 001 001 001 001 001 001 001 002 001 001 001 001 001 001 001 002 002 002 002 001

Nov Oct Dec Dec May May Jul Oct Jul Jun Jun Sep

30, 31, 14, 14, 18, 18, 30, 31, 30, 26, 20, 28,

1994 1994 1995 1995 1992 1992 1993 1994 1993 1995 1995 1993

Apr 02, 1997

Sep 20, 1984

Sep 20, 1984

Nov 30, 1987 Nov 30, 1987

AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

TABLET; ORAL AMILORIDE HYDROCHLORIDE SANDOZ TEVA WATSON LABS HYDRO-RIDE PAR PHARM MODURETIC 5-50 MERCK AND HYDROCHLOROTHIAZIDE EQ 5MG ANHYDROUS;50MG EQ 5MG ANHYDROUS;50MG EQ 5MG ANHYDROUS;50MG EQ 5MG ANHYDROUS;50MG EQ 5MG ANHYDROUS;50MG

A073357 A070795 A073334 A070347 N018201

001 001 001 001 001

Nov 27, 1991 Apr 17, 1988 Jul 19, 1991 Dec 25, 1990

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

AMINO ACIDS
INJECTABLE; INJECTION AMINESS 5.2% ESSENTIAL AMINO ACIDS W/ HISTADINE HOSPIRA 5.2% (5.2GM/100ML) AMINOSYN 3.5% IN PLASTIC CONTAINER ABBOTT 3.5% (3.5GM/100ML) 3.5% (3.5GM/100ML) AMINOSYN II 3.5% HOSPIRA 3.5% (3.5GM/100ML) AMINOSYN II 3.5% IN PLASTIC CONTAINER ABBOTT 3.5% (3.5GM/100ML) AMINOSYN II 5% HOSPIRA 5% (5GM/100ML) AMINOSYN-HBC 7% IN PLASTIC CONTAINER ABBOTT 7% (7GM/100ML) BRANCHAMIN 4% BAXTER HLTHCARE 4% (4GM/100ML) FREAMINE 8.5% B BRAUN 8.5% (8.5GM/100ML) FREAMINE II 8.5% B BRAUN 8.5% (8.5GM/100ML) NEOPHAM 6.4% HOSPIRA 6.4% (6.4GM/100ML) NOVAMINE 11.4% HOSPIRA INC 11.4% (11.4GM/100ML) NOVAMINE 15% HOSPIRA INC 15% (15GM/100ML) NOVAMINE 15% SULFITE FREE IN PLASTIC CONTAINER BAXTER HLTHCARE 15% (15GM/100ML) NOVAMINE 8.5% HOSPIRA INC 8.5% (8.5GM/100ML)

6 - 15 (of 346)

N018901 N018804 N018875 N019438 N019491 N019438 N019400 N018678 N016822 N016822 N018792 N017957 N017957 N020107 N017957

001 001 001 001 001 002 001 001 001 002 001 003 004 001 002

Apr 06, 1984 May 15, 1984 Aug 08, 1984 Apr 03, 1986 Oct 10, 1986 Apr 03, 1986 Jul 23, 1986 Sep 28, 1984

Jan 17, 1984 Aug 09, 1982 Nov 28, 1986 Feb 05, 1993 Aug 09, 1982

AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE
INJECTABLE; INJECTION AMINOSYN II 3.5% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER ABBOTT 3.5%;36.8MG/100ML;25GM/100ML;51MG/100ML N019714 001 Sep ;22.4MG/100ML;261MG/100ML;205MG/100ML HOSPIRA INC 3.5%;36.8MG/100ML;25GM/100ML;51MG/100ML N019683 001 Nov ;22.4MG/100ML;261MG/100ML;205MG/100ML AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER ABBOTT 4.25%;36.8MG/100ML;20GM/100ML;51MG/100M N019714 002 Sep L;22.4MG/100ML;261MG/100ML;205MG/100ML HOSPIRA INC 4.25%;36.8MG/100ML;20GM/100ML;51MG/100M N019683 002 Nov L;22.4MG/100ML;261MG/100ML;205MG/100ML AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER ABBOTT 4.25%;36.8MG/100ML;25GM/100ML;51MG/100M N019714 004 Sep L;22.4MG/100ML;261MG/100ML;205MG/100ML HOSPIRA INC 4.25%;36.8MG/100ML;25GM/100ML;51MG/100M N019683 003 Nov L;22.4MG/100ML;261MG/100ML;205MG/100ML AMINOSYN II 5% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER ABBOTT 5%;36.8MG/100ML;25GM/100ML;51MG/100ML;2 N019714 003 Sep 2.4MG/100ML;261MG/100ML;205MG/100ML HOSPIRA INC 5%;36.8MG/100ML;25GM/100ML;51MG/100ML;2 N019683 004 Nov 2.4MG/100ML;261MG/100ML;205MG/100ML

12, 1988 07, 1988

12, 1988 07, 1988

12, 1988 07, 1988

12, 1988 07, 1988

AMINO ACIDS; DEXTROSE

INJECTABLE; INJECTION AMINOSYN 3.5% W/ DEXTROSE 25% IN PLASTIC CONTAINER ABBOTT 3.5%;25GM/100ML AMINOSYN 3.5% W/ DEXTROSE 5% IN PLASTIC CONTAINER ABBOTT 3.5%;5GM/100ML AMINOSYN 4.25% W/ DEXTROSE 25% IN PLASTIC CONTAINER ABBOTT 4.25%;25GM/100ML

N019118 N019120 N019119

001 001 001

Oct 11, 1984 Oct 11, 1984 Oct 11, 1984

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

AMINO ACIDS; DEXTROSE
INJECTABLE; INJECTION AMINOSYN II 3.5% IN DEXTROSE 25% IN PLASTIC CONTAINER ABBOTT 3.5%;25GM/100ML 3.5%;25GM/100ML HOSPIRA 3.5%;25GM/100ML AMINOSYN II 3.5% IN DEXTROSE 5% IN PLASTIC CONTAINER ABBOTT 3.5%;5GM/100ML 3.5%;5GM/100ML HOSPIRA 3.5%;5GM/100ML AMINOSYN II 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER ABBOTT 4.25%;10GM/100ML HOSPIRA 4.25%;10GM/100ML AMINOSYN II 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER ABBOTT 4.25%;20GM/100ML HOSPIRA 4.25%;20GM/100ML AMINOSYN II 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER ABBOTT 4.25%;25GM/100ML 4.25%;25GM/100ML HOSPIRA 4.25%;25GM/100ML AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER ABBOTT 5%;25GM/100ML 5%;25GM/100ML HOSPIRA 5%;25GM/100ML TRAVASOL 2.75% IN DEXTROSE 10% IN PLASTIC CONTAINER BAXTER HLTHCARE 2.75%;10GM/100ML TRAVASOL 2.75% IN DEXTROSE 15% IN PLASTIC CONTAINER BAXTER HLTHCARE 2.75%;15GM/100ML TRAVASOL 2.75% IN DEXTROSE 20% IN PLASTIC CONTAINER BAXTER HLTHCARE 2.75%;20GM/100ML TRAVASOL 2.75% IN DEXTROSE 25% IN PLASTIC CONTAINER BAXTER HLTHCARE 2.75%;25GM/100ML TRAVASOL 2.75% IN DEXTROSE 5% IN PLASTIC CONTAINER BAXTER HLTHCARE 2.75%;5GM/100ML TRAVASOL 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER BAXTER HLTHCARE 4.25%;10GM/100ML TRAVASOL 4.25% IN DEXTROSE 15% IN PLASTIC CONTAINER BAXTER HLTHCARE 4.25%;15GM/100ML TRAVASOL 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER BAXTER HLTHCARE 4.25%;20GM/100ML TRAVASOL 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER BAXTER HLTHCARE 4.25%;25GM/100ML TRAVASOL 4.25% IN DEXTROSE 5% IN PLASTIC CONTAINER BAXTER HLTHCARE 4.25%;5GM/100ML

6 - 16 (of 346)

N019505 N019713 N019681 N019506 N019713 N019681 N019713 N019681 N019713 N019681 N019504 N019713 N019681 N019565 N019713 N019681 N019520 N019520 N019520 N019520 N019520 N019520 N019520 N019520 N019520 N019520

002 006 001 001 002 002 001 004 004 005 002 005 003 001 003 006 002 003 004 005 001 007 008 009 010 006

Nov 07, 1986 Sep 09, 1988 Nov 01, 1988 Nov 07, 1986 Sep 09, 1988 Nov 01, 1988 Sep 09, 1988 Nov 01, 1988 Sep 09, 1988 Nov 01, 1988 Nov 07, 1986 Sep 09, 1988 Nov 01, 1988 Dec 17, 1986 Sep 09, 1988 Nov 01, 1988 Sep 23, 1988 Sep 23, 1988 Sep 23, 1988 Sep 23, 1988 Sep 23, 1988 Sep 23, 1988 Sep 23, 1988 Sep 23, 1988 Sep 23, 1988 Sep 23, 1988

AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM ACETATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE
INJECTABLE; INJECTION AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER ABBOTT 4.25%;10GM/100ML;51MG/100ML;176.5MG/100 N019712 002 Sep 08, 1988 ML;22.4MG/100ML;104.5MG/100ML;205MG/100 ML HOSPIRA INC 4.25%;10GM/100ML;51MG/100ML;176.5MG/100 N019682 003 Nov 01, 1988 ML;22.4MG/100ML;104.5MG/100ML;205MG/100 ML

AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE
INJECTABLE; INJECTION AMINOSYN II 3.5% W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER ABBOTT 3.5%;25GM/100ML;51MG/100ML;22.4MG/100ML N019564 ;261MG/100ML;205MG/100ML AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER ABBOTT 4.25%;25GM/100ML;51MG/100ML;22.4MG/100M N019564 L;261MG/100ML;205MG/100ML

002

Dec 16, 1986

004

Dec 16, 1986

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 17 (of 346)

AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
INJECTABLE; INJECTION AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER ABBOTT 3.5%;5GM/100ML;30MG/100ML;97MG/100ML;12 0MG/100ML;49.3MG/100ML 3.5%;5GM/100ML;30MG/100ML;97MG/100ML;12 0MG/100ML;49.3MG/100ML HOSPIRA INC 3.5%;5GM/100ML;30MG/100ML;97MG/100ML;12 0MG/100ML;49.3MG/100ML AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER ABBOTT 4.25%;10GM/100ML;30MG/100ML;97MG/100ML; 120MG/100ML;49.3MG/100ML HOSPIRA INC 4.25%;5GM/100ML;30MG/100ML;97MG/100ML;1 20MG/100ML;49.3MG/100ML

N019564 N019712 N019682

001 001 001

Dec 16, 1986 Sep 08, 1988 Nov 01, 1988

N019564 N019682

003 002

Dec 16, 1986 Nov 01, 1988

AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE
INJECTABLE; INJECTION TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 10% IN PLASTIC CONTAINER BAXTER HLTHCARE 2.75%;10GM/100ML;51MG/100ML;261MG/100ML N020147 002 Oct ;216MG/100ML;112MG/100ML TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 15% IN PLASTIC CONTAINER BAXTER HLTHCARE 2.75%;15GM/100ML;51MG/100ML;261MG/100ML N020147 003 Oct ;216MG/100ML;112MG/100ML TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 20% IN PLASTIC CONTAINER BAXTER HLTHCARE 2.75%;20GM/100ML;51MG/100ML;261MG/100ML N020147 004 Oct ;216MG/100ML;112MG/100ML TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER BAXTER HLTHCARE 2.75%;25GM/100ML;51MG/100ML;261MG/100ML N020147 005 Oct ;216MG/100ML;112MG/100ML TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 5% IN PLASTIC CONTAINER BAXTER HLTHCARE 2.75%;5GM/100ML;51MG/100ML;261MG/100ML; N020147 001 Oct 216MG/100ML;112MG/100ML TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 10% IN PLASTIC CONTAINER BAXTER HLTHCARE 4.25%;10GM/100ML;51MG/100ML;261MG/100ML N020147 007 Oct ;297MG/100ML;77MG/100ML TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 15% IN PLASTIC CONTAINER BAXTER HLTHCARE 4.25%;15GM/100ML;51MG/100ML;261MG/100ML N020147 008 Oct ;297MG/100ML;77MG/100ML TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 20% IN PLASTIC CONTAINER BAXTER HLTHCARE 4.25%;20GM/100ML;51MG/100ML;261MG/100ML N020147 009 Oct ;297MG/100ML;77MG/100ML TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER BAXTER HLTHCARE 4.25%;25GM/100ML;51MG/100ML;261MG/100ML N020147 010 Oct ;297MG/100ML;77MG/100ML TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 5% IN PLASTIC CONTAINER BAXTER HLTHCARE 4.25%;5GM/100ML;51MG/100ML;261MG/100ML; N020147 006 Oct 297MG/100ML;77MG/100ML

23, 1995

23, 1995

23, 1995

23, 1995

23, 1995

23, 1995

23, 1995

23, 1995

23, 1995

23, 1995

AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM ACETATE; SODIUM CHLORIDE

INJECTABLE; INJECTION

AMINOSYN 3.5% M IN PLASTIC CONTAINER
ABBOTT 3.5%;21MG/100ML;40MG/100ML;128MG/100ML; N018804 234MG/100ML 3.5%;21MG/100ML;40MG/100ML;128MG/100ML; N018875 234MG/100ML

002 002

May 15, 1984 Aug 08, 1984

AMINO ACIDS; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE

INJECTABLE; INJECTION

AMINOSYN 3.5% M

HOSPIRA

3.5%;21MG/100ML;128MG/100ML;234MG/100ML N017789

005

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 18 (of 346)

AMINO ACIDS; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
INJECTABLE; INJECTION AMINOSYN II 3.5% M IN PLASTIC CONTAINER ABBOTT 3.5%;32MG/100ML;128MG/100ML;222MG/100ML N019493 ;49MG/100ML

001

Oct 16, 1986

AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM ACETATE; POTASSIUM CHLORIDE; SODIUM ACETATE
INJECTABLE; INJECTION VEINAMINE 8% HOSPIRA INC

8%;61MG/100ML;211MG/100ML;56MG/100ML;38 N017957 8MG/100ML

001

AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE
INJECTABLE; INJECTION AMINOSYN II 7% W/ ELECTROLYTES HOSPIRA 7%;102MG/100ML;45MG/100ML;522MG/100ML;4 N019437 10MG/100ML

006

Apr 03, 1986

AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
INJECTABLE; INJECTION AMINOSYN II 3.5% M HOSPIRA

3.5%;30MG/100ML;97MG/100ML;120MG/100ML; N019437 49MG/100ML

007

Apr 03, 1986

AMINOCAPROIC ACID
INJECTABLE; INJECTION

AMICAR

XANODYNE PHARM AMINOCAPROIC ACID ABRAXIS PHARM BAXTER HLTHCARE HOSPIRA

250MG/ML 250MG/ML 250MG/ML 250MG/ML

N015229 A070522 N018590 A070888

002

001 001 001 Jun 17, 1986 Oct 29, 1982 Jun 16, 1988

AMINOGLUTETHIMIDE
TABLET; ORAL

CYTADREN

NOVARTIS

250MG

N018202

001

AMINOPHYLLINE
ENEMA; RECTAL SOMOPHYLLIN FISONS INJECTABLE; INJECTION AMINOPHYLLIN GD SEARLE LLC AMINOPHYLLINE ABRAXIS PHARM

300MG/5ML

N018232

001

Apr 02, 1982

25MG/ML 25MG/ML 25MG/ML 25MG/ML 25MG/ML 25MG/ML 25MG/ML 25MG/ML 25MG/ML 25MG/ML 25MG/ML 25MG/ML 25MG/ML 25MG/ML 25MG/ML 25MG/ML

A087243 A087621 A084568 A087200 A087250 A087886 A088407 A087239 A087601 A087867 A087868 A086606 A087240 A087431 A087387 A088429

001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001

May 24, 1982 May 24, 1982

Jan 06, 1982 Aug 30, 1983 Jan 25, 1984 Jul 23, 1982 Nov 10, 1983 Nov 10, 1983

ELKINS SINN HOSPIRA INTL MEDICATION KING PHARMS LUITPOLD LYPHOMED PHARMA SERVE NY SMITH AND NEPHEW

Jun 03, 1983 May 30, 1985

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

AMINOPHYLLINE
INJECTABLE; INJECTION AMINOPHYLLINE SMITH AND NEPHEW TEVA PARENTERAL AMINOPHYLLINE IN SODIUM HOSPIRA

6 - 19 (of 346)

25MG/ML 25MG/ML CHLORIDE 0.45% 100MG/100ML 200MG/100ML AMINOPHYLLINE IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER HOSPIRA 100MG/100ML 200MG/100ML 400MG/100ML 500MG/100ML SOLUTION; ORAL AMINOPHYLLINE MORTON GROVE 105MG/5ML ROXANE 105MG/5ML AMINOPHYLLINE DYE FREE ACTAVIS MID ATLANTIC 105MG/5ML SOMOPHYLLIN FISONS 105MG/5ML SOMOPHYLLIN-DF FISONS 105MG/5ML SUPPOSITORY; RECTAL TRUPHYLLINE G AND W LABS 250MG 500MG TABLET; ORAL AMINOPHYLLIN GD SEARLE LLC 100MG 200MG AMINOPHYLLINE ASCOT 100MG 200MG BARR 100MG 200MG DURAMED PHARMS BARR 100MG 200MG HALSEY 100MG IMPAX LABS 100MG 200MG KV PHARM 100MG 200MG LANNETT 100MG 200MG PAL PAK 100MG PANRAY 100MG 200MG PUREPAC PHARM 100MG 200MG ROXANE 100MG 200MG SANDOZ 100MG 100MG 200MG VALEANT PHARM INTL 200MG VANGARD 100MG 200MG VINTAGE PHARMS 100MG 200MG WATSON LABS 100MG 200MG

A088749 A081142 A088147 A088147 N018924 N018924 N018924 N018924

001 001 002 003 001 002 003 004

May 30, 1985 Sep 25, 1991 May 03, 1983 May 03, 1983 Dec Dec Dec Dec 12, 12, 12, 12, 1984 1984 1984 1984

A088156 A088126 A087727 A086466 A087045

001 001 001 001 001

Dec 05, 1983 Aug 19, 1983 Apr 16, 1982

A085498 A085498

001 002

Mar 23, 1983 Jan 03, 1983

N002386 N002386 A087522 A087523 A088297 A088298 A088182 A088183 A084674 A084574 A084576 A085284 A085289 A084588 A084588 A084533 A084552 A084552 A084699 A085333 A087500 A087501 A085261 A085262 A085261 A084563 A088314 A088319 A085409 A085410 A085567 A085564

002 003 001 001 001 001 001 001 001 001 001 001 001 001 002 001 001 002 001 001 001 001 003 002 002 001 001 001 001 001 001 001 Feb Feb Aug Aug Mar Mar 12, 12, 19, 19, 31, 31, 1982 1982 1983 1983 1983 1983

Feb 09, 1982 Feb 09, 1982

Oct 03, 1983 Oct 03, 1983

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

AMINOPHYLLINE
TABLET, DELAYED RELEASE; ORAL AMINOPHYLLINE IMPAX LABS 100MG 200MG TABLICAPS 100MG VALE 100MG 200MG TABLET, EXTENDED RELEASE; ORAL PHYLLOCONTIN PHARM RES ASSOC 225MG

6 - 20 (of 346)

A084577 A084575 A084632 A084531 A084530

001 001 002 001 001

A086760

001

AMINOSALICYLATE SODIUM
POWDER; ORAL
P.A.S. SODIUM
CENTURY PHARMS 4GM/PACKET
SODIUM AMINOSALICYLATE
HEXCEL 100%
TABLET; ORAL

PARASAL SODIUM
PANRAY 500MG 1GM
SODIUM P.A.S.
LANNETT 500MG
TEEBACIN
CONSOLIDATED MIDLAND 500MG

A080947 A080097

001

001

N006811 N006811 A080138 N007320

006

011

002

002

AMINOSALICYLATE SODIUM; AMINOSALICYLIC ACID

TABLET; ORAL NEOPASALATE MEDPOINTE PHARM HLC

846MG;112MG

A080059

002

AMINOSALICYLIC ACID
TABLET; ORAL PARASAL PANRAY

500MG 1GM

N006811 N006811

001 002

AMINOSALICYLIC ACID RESIN COMPLEX

POWDER; ORAL REZIPAS BRISTOL MYERS SQUIBB

EQ 500MG BASE/GM

N009052

001

AMIODARONE HYDROCHLORIDE
INJECTABLE; INJECTION AMIODARONE HYDROCHLORIDE BEN VENUE 50MG/ML HOSPIRA 50MG/ML INTL MEDICATION SYS 50MG/ML CORDARONE WYETH PHARMS INC 50MG/ML TABLET; ORAL AMIODARONE HYDROCHLORIDE TEVA 200MG

A076088 A076108 N021594 N020377

001 001 001 001

Oct 15, 2002 Oct 15, 2002 Feb 04, 2004 Aug 03, 1995

A074895

001

Apr 16, 1999

AMITRIPTYLINE HYDROCHLORIDE
CONCENTRATE; ORAL ENDEP ROCHE 40MG/ML INJECTABLE; INJECTION AMITRIPTYLINE HYDROCHLORIDE WATSON LABS 10MG/ML

A085749

001

A085594

001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

AMITRIPTYLINE HYDROCHLORIDE
INJECTABLE; INJECTION ELAVIL ASTRAZENECA TABLET; ORAL AMITID BRISTOL MYERS SQUIBB

6 - 21 (of 346)

10MG/ML

N012704

001

10MG 25MG 50MG 75MG 100MG

A086454 A086454 A086454 A086454 A086454 A083939 A083937 A083938 A084957 A085093 A086295 A088672 A088673 A088674 A088675 A088421 A088422 A088423 A088424 A088425 A088426 A085923 A085922 A085925 A087557 A085926 A085927 A086744 A087366 A086746 A087367 A086743 A087181 A086745 A087369 A086747 A087368 A087370 A085744 A085627 A085745 A085743 A085742 A089423 A088697 A088698 A088699 A088700 A088701 A088702 A088883 A088884 A088885 A088886 A088887

001 002 003 004 005 001 001 002 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 002 001 001 001 001 001 001 001 001 001 001 001 001 Nov Nov Nov Nov Apr Apr Apr Apr Apr Apr 20, 20, 20, 20, 30, 30, 30, 30, 30, 30, 1984 1984 1984 1984 1984 1984 1984 1984 1984 1984

AMITRIL WARNER CHILCOTT

10MG 25MG 50MG 75MG 100MG 150MG AMITRIPTYLINE HYDROCHLORIDE AM THERAP 25MG 50MG 75MG 100MG COPLEY PHARM 10MG 25MG 50MG 75MG 100MG 150MG HALSEY 10MG 25MG 50MG 50MG 75MG 100MG LEDERLE 10MG 10MG 25MG 25MG 50MG 50MG 75MG 75MG 100MG 100MG 150MG MUTUAL PHARM 10MG 25MG 50MG 75MG 100MG 150MG PAR PHARM 10MG 25MG 50MG 75MG 100MG 150MG PLIVA 10MG 25MG 50MG 75MG 100MG

Mar 05, 1982 May 20, 1983 May 20, 1983 Jan 04, 1982 May 03, 1982 Jan 04, 1982 Jan 04, 1982 May 03, 1982 Jan 04, 1982

May Feb Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep

11, 17, 25, 25, 25, 25, 25, 25, 26, 26, 26, 26, 26,

1982 1987 1984 1984 1984 1984 1984 1984 1984 1984 1984 1984 1984

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

AMITRIPTYLINE HYDROCHLORIDE
TABLET; ORAL AMITRIPTYLINE HYDROCHLORIDE PLIVA 150MG PUREPAC PHARM 10MG 10MG 25MG 25MG 50MG 50MG 75MG 75MG 100MG 100MG ROXANE 10MG 10MG 25MG 25MG 50MG 50MG 75MG 75MG 100MG 100MG 150MG 150MG SUPERPHARM 10MG 25MG 50MG 75MG 100MG TEVA 10MG 10MG 25MG 25MG 50MG 50MG 75MG 75MG 100MG 100MG 150MG UCB INC 10MG 25MG 50MG 75MG 100MG 150MG USL PHARMA 25MG VANGARD 10MG 50MG 75MG 100MG WATSON LABS 10MG 10MG 25MG 25MG 50MG 50MG 75MG 75MG 100MG 100MG

6 - 22 (of 346)

A088888 A088075 A088084 A088076 A088085 A088077 A088105 A088078 A088106 A088079 A088107 A086002 A086144 A085944 A086145 A085945 A086143 A086004 A086147 A086003 A086146 A086090 A086148 A088853 A088854 A088855 A088856 A088857 A084910 A086610 A085031 A086859 A085032 A086857 A085030 A086860 A085836 A086854 A086853 A085864 A085935 A085936 A086337 A086336 A086335 A087775 A087632 A087616 A087617 A087639 A085816 A088620 A085817 A088621 A085815 A088622 A085819 A088633 A085820 A088634

001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 003 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001

Sep Sep Jul May Jul Sep Jul Sep Jul Sep Jul

26, 16, 18, 20, 18, 16, 18, 16, 18, 16, 18,

1984 1983 1983 1983 1983 1983 1983 1983 1983 1983 1983

Nov Nov Nov Nov Nov

13, 13, 13, 13, 13,

1984 1984 1984 1984 1984

Feb Feb Feb Feb Feb

10, 01, 08, 05, 08,

1982 1982 1982 1982 1982

Mar 02, 1984 Mar 02, 1984 Mar 02, 1984 Mar 02, 1984 Mar 02, 1984

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

AMITRIPTYLINE HYDROCHLORIDE
TABLET; ORAL AMITRIPTYLINE HYDROCHLORIDE WATSON LABS 150MG 150MG WEST WARD 10MG 25MG ELAVIL ASTRAZENECA 10MG 25MG 50MG 75MG 100MG 150MG ENDEP ROCHE 10MG 25MG 50MG 75MG 100MG 150MG

6 - 23 (of 346)

A085821 A088635 A087647 A087278 N012703 N012703 N012703 N012703 N012703 N012703 A083639 A083639 A083639 A083639 A083639 A085303

001 001 001 001 001 003 004 005 006 007 001 002 003 004 005 001

Mar 02, 1984 Mar 05, 1982

AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE

TABLET; ORAL CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE MUTUAL PHARM EQ 12.5MG BASE;5MG EQ 25MG BASE;10MG PAR PHARM EQ 12.5MG BASE;5MG EQ 25MG BASE;10MG USL PHARMA EQ 12.5MG BASE;5MG EQ 25MG BASE;10MG WATSON LABS EQ 12.5MG BASE;5MG EQ 25MG BASE;10MG

A070765 A070766 A072277 A072278 A070477 A070478 A072052 A072053

001 001 001 001 001 001 001 001

Dec Dec May May Jan Jan Dec Dec

10, 10, 09, 09, 12, 12, 16, 16,

1986 1986 1988 1988 1988 1988 1988 1988

AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE

TABLET; ORAL ETRAFON 2-10 SCHERING 10MG;2MG ETRAFON 2-25 SCHERING 25MG;2MG ETRAFON-A SCHERING 10MG;4MG ETRAFON-FORTE SCHERING 25MG;4MG PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE IVAX SUB TEVA PHARMS 10MG;2MG 10MG;4MG 25MG;2MG 25MG;4MG 50MG;4MG MUTUAL PHARM 10MG;2MG 10MG;4MG 25MG;2MG 25MG;4MG PAR PHARM 10MG;2MG 10MG;4MG 25MG;2MG 25MG;4MG 50MG;4MG SANDOZ 10MG;2MG 10MG;4MG 25MG;2MG 25MG;4MG

N014713 N014713 N014713 N014713 A070935 A070937 A070936 A070938 A070939 A071077 A071078 A070297 A071079 A070565 A070620 A070621 A070595 A070574 A071062 A071862 A071063 A071064

007 004 002 006 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 Sep Sep Sep Sep Sep Nov Nov Nov Nov Sep Sep Sep Sep Sep Nov Dec Nov Nov 11, 11, 11, 11, 12, 12, 12, 12, 12, 11, 11, 11, 11, 11, 27, 21, 27, 27, 1986 1986 1986 1986 1986 1986 1986 1986 1986 1986 1986 1986 1986 1986 1987 1987 1987 1987

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE
TABLET; ORAL PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE SANDOZ 50MG;4MG WATSON LABS 10MG;2MG 10MG;2MG 10MG;2MG 10MG;4MG 10MG;4MG 10MG;4MG 25MG;2MG 25MG;2MG 25MG;2MG 25MG;4MG 25MG;4MG 25MG;4MG 50MG;4MG 50MG;4MG 50MG;4MG TRIAVIL 2-10 NEW RIVER 10MG;2MG TRIAVIL 2-25 NEW RIVER 25MG;2MG TRIAVIL 4-10 NEW RIVER 10MG;4MG TRIAVIL 4-25 NEW RIVER 25MG;4MG TRIAVIL 4-50 NEW RIVER 50MG;4MG

6 - 24 (of 346)

A071863 A070373 A072539 A073007 A070375 A072540 A073009 A070374 A072541 A073008 A070376 A072134 A073010 A070377 A071558 A072135 N014715 N014715 N014715 N014715 N014715

001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 004 002 003 005 006

Dec Aug Feb Oct Aug Feb Oct Aug Feb Oct Aug Feb Oct Nov Mar Feb

21, 25, 15, 17, 25, 15, 17, 25, 15, 17, 25, 15, 17, 04, 02, 15,

1987 1986 1989 1991 1986 1989 1991 1986 1989 1991 1986 1989 1991 1986 1987 1989

AMLEXANOX
PATCH; TOPICAL AMLEXANOX ULURU

2MG

N021727

001

Sep 29, 2004

AMLODIPINE BESYLATE
TABLET; ORAL AMLODIPINE BESYLATE GEDEON RICHTER USA

EQ 2.5MG BASE EQ 5MG BASE EQ 10MG BASE GENPHARM EQ 2.5MG BASE EQ 5MG BASE EQ 10MG BASE MUTUAL PHARMA EQ 2.5MG BASE EQ 5MG BASE EQ 10MG BASE SYNTHON PHARMS EQ 2.5MG BASE EQ 5MG BASE EQ 10MG BASE TABLET, ORALLY DISINTEGRATING; ORAL AMLODIPINE BESYLATE SYNTHON PHARMS EQ 2.5MG BASE EQ 5MG BASE EQ 10MG BASE

A077333 A077333 A077333 A077362 A077362 A077362 A078081 A078081 A078081 A077080 A077080 A077080

001 002 003 001 002 003 001 002 003 001 002 003

Jul Jul Jul Jul Jul Jul Jan Jan Jan Jun Jun Jun

17, 17, 17, 09, 09, 09, 31, 31, 31, 27, 27, 27,

2007 2007 2007 2007 2007 2007 2008 2008 2008 2007 2007 2007

N022026 N022026 N022026

001 002 003

Sep 27, 2007 Sep 27, 2007 Sep 27, 2007

AMLODIPINE MALEATE
TABLET; ORAL AMVAZ DR REDDYS LABS INC

2.5MG 5MG 10MG

N021435 N021435 N021435

001 002 003

Oct 31, 2003 Oct 31, 2003 Oct 31, 2003

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

AMMONIUM CHLORIDE
INJECTABLE; INJECTION AMMONIUM CHLORIDE ABBOTT 5MEQ/ML GD SEARLE LLC 3MEQ/ML AMMONIUM CHLORIDE 0.9% IN NORMAL SALINE MCGAW 900MG/100ML AMMONIUM CHLORIDE 2.14% B BRAUN 40MEQ/100ML

6 - 25 (of 346)

A083130 A086205 N006580 A085734

001 001 001 001

AMODIAQUINE HYDROCHLORIDE
TABLET; ORAL CAMOQUIN HYDROCHLORIDE PARKE DAVIS

EQ 200MG BASE

N006441

001

AMOXAPINE
TABLET; ORAL AMOXAPINE SANDOZ

WATSON LABS

25MG 50MG 100MG 150MG 25MG 50MG 100MG 150MG 25MG 50MG 100MG 150MG

A072943 A072944 A072878 A072879 A072418 A072419 A072420 A072421 N018021 N018021 N018021 N018021

001 001 001 001 001 001 001 001 001 002 003 004

Jun Jun Jun Jun May May May May

28, 28, 28, 28, 11, 11, 11, 11,

1991 1991 1991 1991 1989 1989 1989 1989

ASENDIN LEDERLE

AMOXICILLIN
CAPSULE; ORAL AMOXICILLIN LABS ATRAL MYLAN TEVA

250MG 500MG 250MG 500MG 250MG 250MG 500MG 500MG 250MG 500MG 250MG 250MG 250MG 250MG 500MG 500MG 500MG 500MG 250MG 500MG 250MG 500MG

A062528 A062528 A062067 A062067 A062853 A063030 A062854 A063031 N050459 N050459 A061885 A062098 A062152 A063099 A061885 A062098 A062152 A063099 A062107 A062107 A062120 A062120

001 002 001 002 001 001 001 001 001 002 001 001 001 001 002 002 002 002 001 002 001 002

Aug 07, 1985 Aug 07, 1985

Dec Feb Dec Feb

22, 28, 22, 28,

1987 1989 1987 1989

AMOXIL GLAXOSMITHKLINE TRIMOX APOTHECON

Mar 20, 1992

Mar 20, 1992

UTIMOX PARKE DAVIS WYMOX WYETH AYERST

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

AMOXICILLIN
FOR SUSPENSION; ORAL

AMOXICILLIN

AM ANTIBIOTICS MYLAN TEVA AMOXIL GLAXOSMITHKLINE

6 - 26 (of 346)

125MG/5ML 250MG/5ML 125MG/5ML 250MG/5ML 125MG/5ML 250MG/5ML 50MG/ML 125MG/5ML 250MG/5ML 50MG/ML 125MG/5ML 125MG/5ML 250MG/5ML 250MG/5ML 50MG/ML 125MG/5ML 125MG/5ML 125MG/5ML 125MG/5ML 250MG/5ML 250MG/5ML 250MG/5ML 250MG/5ML 125MG/5ML 250MG/5ML 125MG/5ML 250MG/5ML

A062059 A062059 A062090 A062090 A062946 A063001 N050460 N050460 N050460 N050460 A061851 A062323 A061851 A062323 A061886 A061886 A062099 A062154 A062885 A061886 A062099 A062154 A062885 A062127 A062127 A062131 A062131

001

002

001

002

001 001 005

001

002

006

001

001

002

002

001 002 001 001 001 003 002 002 002
001

002

001

002

Nov 01, 1988 Jan 06, 1989

LAROTID

GLAXOSMITHKLINE POLYMOX

APOTHECON

TRIMOX APOTHECON

Mar 08, 1988

Mar 08, 1988

UTIMOX
PARKE DAVIS
WYMOX
WYETH AYERST
TABLET, CHEWABLE; ORAL

AMOXICILLIN
APOTHECON

125MG 250MG TEVA 125MG 250MG TABLET, FOR SUSPENSION; ORAL DISPERMOX RANBAXY LABS LTD 200MG 400MG

A064131 A064131 A064031 A064031

001 002 001 002

May May Dec Dec

06, 06, 19, 19,

1996 1996 1996 1996

A065080 A065080

002 001

Aug 11, 2003 Aug 11, 2003

AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATE

CAPSULE; ORAL DELCOBESE TEVA

1.25MG;1.25MG;1.25MG;1.25MG 2.5MG;2.5MG;2.5MG;2.5MG 3.75MG;3.75MG;3.75MG;3.75MG 5MG;5MG;5MG;5MG

A083564 A083564 A083564 A083564

001

002

003

004

TABLET; ORAL

DELCOBESE

TEVA

1.25MG;1.25MG;1.25MG;1.25MG 2.5MG;2.5MG;2.5MG;2.5MG 3.75MG;3.75MG;3.75MG;3.75MG 5MG;5MG;5MG;5MG

A083563 A083563 A083563 A083563

004

003

002

001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
TABLET; ORAL ADDERALL 10 TEVA WOMENS 2.5MG;2.5MG;2.5MG;2.5MG N011522 ADDERALL 12.5 TEVA WOMENS 3.125MG;3.125MG;3.125MG;3.125MG N011522 ADDERALL 15 TEVA WOMENS 3.75MG;3.75MG;3.75MG;3.75MG N011522 ADDERALL 20 TEVA WOMENS 5MG;5MG;5MG;5MG N011522 ADDERALL 30 TEVA WOMENS 7.5MG;7.5MG;7.5MG;7.5MG N011522 ADDERALL 5 TEVA WOMENS 1.25MG;1.25MG;1.25MG;1.25MG N011522 ADDERALL 7.5 TEVA WOMENS 1.875MG;1.875MG;1.875MG;1.875MG N011522 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE MALLINCKRODT INC 1.25MG;1.25MG;1.25MG;1.25MG A040440 1.875MG;1.875MG;1.875MG;1.875MG A040440 2.5MG;2.5MG;2.5MG;2.5MG A040440 3.125MG;3.125MG;3.125MG;3.125MG A040440 3.75MG;3.75MG;3.75MG;3.75MG A040440 5MG;5MG;5MG;5MG A040440 7.5MG;7.5MG;7.5MG;7.5MG A040440 MUTUAL PHARM 1.25MG;1.25MG;1.25MG;1.25MG A040480 1.875MG;1.875MG;1.875MG;1.875MG A040480 2.5MG;2.5MG;2.5MG;2.5MG A040480 3.125MG;3.125MG;3.125MG;3.125MG A040480 3.75MG;3.75MG;3.75MG;3.75MG A040480 5MG;5MG;5MG;5MG A040480 7.5MG;7.5MG;7.5MG;7.5MG A040480 WATSON LABS 1.25MG;1.25MG;1.25MG;1.25MG A040456 2.5MG;2.5MG;2.5MG;2.5MG A040456 5MG;5MG;5MG;5MG A040456 7.5MG;7.5MG;7.5MG;7.5MG A040456

6 - 27 (of 346)

007 012 013 008 010 009 011 001 002 003 004 005 006 007 001 002 003 004 005 006 007 001 002 003 004

Feb 13, 1996 Aug 31, 2000 Aug 31, 2000 Feb 13, 1996 May 12, 1997 May 12, 1997 Aug 31, 2000 Oct Oct Oct Oct Oct Oct Oct Sep Sep Sep Sep Sep Sep Sep May May May May 07, 07, 07, 07, 07, 07, 07, 09, 09, 09, 09, 09, 09, 09, 06, 06, 06, 06, 2003 2003 2003 2003 2003 2003 2003 2003 2003 2003 2003 2003 2003 2003 2003 2003 2003 2003

AMPHETAMINE RESIN COMPLEX; DEXTROAMPHETAMINE RESIN COMPLEX

CAPSULE, EXTENDED RELEASE; ORAL

BIPHETAMINE 12.5

UCB INC EQ 6.25MG BASE;EQ 6.25MG BASE BIPHETAMINE 20

UCB INC EQ 10MG BASE;EQ 10MG BASE BIPHETAMINE 7.5

UCB INC EQ 3.75MG BASE;EQ 3.75MG BASE

N010093 N010093 N010093

007

003

009

AMPHETAMINE SULFATE
TABLET; ORAL AMPHETAMINE SULFATE LANNETT

5MG 10MG

A083901 A083901

001 002

Aug 31, 1984 Aug 31, 1984

AMPHOTERICIN B
CREAM; TOPICAL FUNGIZONE APOTHECON INJECTABLE; INJECTION AMPHOTERICIN B ABBOTT ABRAXIS PHARM TEVA PARENTERAL FUNGIZONE APOTHECON

3%

N050314

001

50MG/VIAL 50MG/VIAL 50MG/VIAL 50MG/VIAL

A064141 A062728 A064062 A060517

001 001 001 001

Dec 23, 1996 Apr 13, 1987 Mar 31, 1995

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

AMPHOTERICIN B
LOTION; TOPICAL FUNGIZONE APOTHECON OINTMENT; TOPICAL FUNGIZONE APOTHECON SUSPENSION; ORAL FUNGIZONE BRISTOL MYERS SQUIBB

6 - 28 (of 346)

3%

A060570

001

3%

N050313

001

100MG/ML

N050341

003

AMPICILLIN SODIUM
INJECTABLE; INJECTION AMPICILLIN SODIUM APOTHECON

BAXTER HLTHCARE

CONSOLIDATED PHARM

HANFORD GC

INTL MEDICATION LILLY

MARSAM PHARMS LLC

EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ

125MG BASE/VIAL 250MG BASE/VIAL 500MG BASE/VIAL 1GM BASE/VIAL 2GM BASE/VIAL 125MG BASE/VIAL 250MG BASE/VIAL 500MG BASE/VIAL 1GM BASE/VIAL 2GM BASE/VIAL 10GM BASE/VIAL 125MG BASE/VIAL 250MG BASE/VIAL 500MG BASE/VIAL 1GM BASE/VIAL 2GM BASE/VIAL 125MG BASE/VIAL 500MG BASE/VIAL 1GM BASE/VIAL 2GM BASE/VIAL 1GM BASE/VIAL 2GM BASE/VIAL 500MG BASE/VIAL 1GM BASE/VIAL 2GM BASE/VIAL 125MG BASE/VIAL 250MG BASE/VIAL 500MG BASE/VIAL 1GM BASE/VIAL 2GM BASE/VIAL 10GM BASE/VIAL 125MG BASE/VIAL 125MG BASE/VIAL 250MG BASE/VIAL 250MG BASE/VIAL 500MG BASE/VIAL 500MG BASE/VIAL 1GM BASE/VIAL 1GM BASE/VIAL 2GM BASE/VIAL 2GM BASE/VIAL 125MG BASE/VIAL 250MG BASE/VIAL 500MG BASE/VIAL 1GM BASE/VIAL 2GM BASE/VIAL 4GM BASE/VIAL

A062860 A062860 A062860 A062860 A062860 A062692 A062692 A062692 A062692 A062692 A062692 A061936 A061936 A061936 A061936 A061936 A063143 A063147 A063139 A063141 A062634 A062634 A062565 A062565 A062565 A062816 A062816 A062816 A062816 A062816 A062994 A060626 A062718 A060626 A062718 A060626 A062718 A060626 A062718 A060626 A062718 N050072 N050072 N050072 N050072 N050072 N050072

001 002 003 004 005 001 002 003 004 005 006 005 001 002 003 004 001 001 001 001 002 003 001 002 003 001 002 003 004 005 001 001 001 002 002 003 003 004 004 005 005 001 002 003 004 005 006

Feb Feb Feb Feb Feb Jun Jun Jun Jun Jun Jun

05, 05, 05, 05, 05, 24, 24, 24, 24, 24, 24,

1988 1988 1988 1988 1988 1986 1986 1986 1986 1986 1986

Apr Apr Apr Apr Jan Jan Apr Apr Jun Oct Oct Oct Oct Oct Sep

15, 15, 15, 15, 09, 09, 04, 04, 24, 24, 24, 24, 24, 24, 15,

1993 1993 1993 1993 1987 1987 1985 1985 1986 1988 1988 1988 1988 1988 1988

OMNIPEN-N WYETH AYERST

Dec 16, 1986 Dec 16, 1986 Dec 16, 1986 Dec 16, 1986 Dec 16, 1986

PENBRITIN-S WYETH AYERST

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

AMPICILLIN SODIUM
INJECTABLE; INJECTION POLYCILLIN-N BRISTOL

6 - 29 (of 346)

EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ

125MG BASE/VIAL 250MG BASE/VIAL 500MG BASE/VIAL 1GM BASE/VIAL 2GM BASE/VIAL 125MG BASE/VIAL 250MG BASE/VIAL 500MG BASE/VIAL 1GM BASE/VIAL 1GM BASE/VIAL 2GM BASE/VIAL 2GM BASE/VIAL 10GM BASE/VIAL

N050309 N050309 N050309 N050309 N050309 A060677 A060677 A060677 A060677 A062727 A060677 A062727 A060677

001 002 003 004 005 001 002 003 004 001 005 002 006

TOTACILLIN-N GLAXOSMITHKLINE

Dec 19, 1986 Dec 19, 1986

AMPICILLIN SODIUM; SULBACTAM SODIUM

INJECTABLE; INJECTION UNASYN PFIZER

EQ 500MG BASE/VIAL;EQ 250MG BASE/VIAL

N050608

003

Dec 31, 1986

AMPICILLIN/AMPICILLIN TRIHYDRATE
CAPSULE; ORAL AMCILL PARKE DAVIS AMPICILLIN TRIHYDRATE AM ANTIBIOTICS IVAX SUB TEVA PHARMS LEDERLE MYLAN PUREPAC PHARM TEVA VITARINE OMNIPEN (AMPICILLIN) WYETH AYERST PENBRITIN WYETH AYERST PFIZERPEN-A PFIZER POLYCILLIN BRISTOL PRINCIPEN APOTHECON BRISTOL MYERS SQUIBB PRINCIPEN '250' APOTHECON

EQ 250MG BASE EQ 500MG BASE EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ 250MG 500MG 250MG 500MG 250MG 500MG 250MG 500MG 250MG 500MG 250MG 500MG 250MG 500MG BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE

A062041 A062041 A061602 A061602 A060765 A060765 A062208 A062208 A061755 A061755 A061853 A061853 A061502 A061502 A061387 A061387 A060624 A060624 A060908 A060908 A062050 A062050 N050310 N050310 A062888 A062888 A061392 A061392 A062157 N050056

001 002 001 002 001 002 001 002 001 002 001 002 001 002 001 003 001 002 001 002 001 002 001 002 001 002 001 002 002 001 Mar 04, 1988 Mar 04, 1988

250MG 500MG EQ 250MG BASE EQ 500MG BASE EQ 250MG BASE EQ 500MG BASE EQ 250MG BASE EQ 500MG BASE EQ EQ EQ EQ 250MG 500MG 250MG 500MG BASE BASE BASE BASE

EQ 250MG BASE EQ 250MG BASE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

AMPICILLIN/AMPICILLIN TRIHYDRATE
CAPSULE; ORAL PRINCIPEN '500' APOTHECON TOTACILLIN GLAXOSMITHKLINE

6 - 30 (of 346)

EQ 500MG BASE EQ 500MG BASE EQ EQ EQ EQ 250MG 250MG 500MG 500MG BASE BASE BASE BASE

A062157 N050056 A060060 A062212 A060060 A062212

001 002 001 001 002 002

FOR SUSPENSION; ORAL AMCILL PARKE DAVIS AMPICILLIN TRIHYDRATE AM ANTIBIOTICS MYLAN PUREPAC PHARM TEVA OMNIPEN (AMPICILLIN) WYETH AYERST

EQ 125MG BASE/5ML EQ 250MG BASE/5ML EQ EQ EQ EQ EQ EQ EQ EQ 125MG 250MG 125MG 250MG 125MG 250MG 125MG 250MG BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML

A062030 A062030 A061601 A061601 A061829 A061829 A061980 A061980 A061370 A061370 A060625 A060625 A060625 A060625 N050019 N050019 N050019 A062049 A062049 A062297 A062297 N050308 N050308 N050308 N050308 A061394 A061394 A061394 A060127 A062151 A060127 A062151 A060666 A062223 A060666 A062223

001 002 001 002 002 001 001 002 001 002 001 002 003 004 001 002 003 001 002 001 002 004 001 002 003 001 002 003 002 001 001 002 001 001 002 002

100MG/ML 125MG/5ML 250MG/5ML 500MG/5ML EQ 100MG BASE/ML EQ 125MG BASE/5ML EQ 250MG BASE/5ML EQ 125MG BASE/5ML EQ 250MG BASE/5ML EQ EQ EQ EQ EQ EQ 125MG 250MG 100MG 125MG 250MG 500MG BASE/5ML BASE/5ML BASE/ML BASE/5ML BASE/5ML BASE/5ML

PENBRITIN WYETH AYERST

PFIZERPEN-A PFIZER POLYCILLIN APOTHECON BRISTOL

PRINCIPEN APOTHECON

EQ 100MG BASE/ML EQ 125MG BASE/5ML EQ 250MG BASE/5ML EQ 125MG BASE/5ML EQ 125MG BASE/5ML EQ 250MG BASE/5ML EQ 250MG BASE/5ML EQ EQ EQ EQ 125MG 125MG 250MG 250MG BASE/5ML BASE/5ML BASE/5ML BASE/5ML

PRINCIPEN '125' APOTHECON PRINCIPEN '250' APOTHECON TOTACILLIN GLAXOSMITHKLINE

TABLET, CHEWABLE; ORAL POLYCILLIN BRISTOL

EQ 125MG BASE

N050093

001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

AMPICILLIN/AMPICILLIN TRIHYDRATE; PROBENECID
CAPSULE; ORAL PRINCIPEN W/ PROBENECID APOTHECON EQ EQ FOR SUSPENSION; ORAL POLYCILLIN-PRB APOTHECON EQ BRISTOL EQ PROBAMPACIN TEVA EQ

6 - 31 (of 346)

389MG BASE;111MG 389MG BASE;111MG

A062150 N050488

001 001

3.5GM BASE/BOT;1GM/BOT 3.5GM BASE/BOT;1GM/BOT 3.5GM BASE/BOT;1GM/BOT

A061898 N050457 A061741

001 001 001

AMPRENAVIR
CAPSULE; ORAL AGENERASE GLAXOSMITHKLINE SOLUTION; ORAL AGENERASE GLAXOSMITHKLINE

50MG 150MG

N021007 N021007

001 002

Apr 15, 1999 Apr 15, 1999

15MG/ML

N021039

001

Apr 15, 1999

ANAGRELIDE HYDROCHLORIDE
CAPSULE; ORAL AGRYLIN SHIRE EQ 1MG BASE ANAGRELIDE HYDROCHLORIDE ROXANE EQ 0.5MG BASE EQ 1MG BASE

N020333 A076489 A076489

002 001 002

Mar 14, 1997 Apr 18, 2005 Apr 18, 2005

ANASTROZOLE
TABLET; ORAL ANASTROZOLE SYNTHON PHARMS

1MG

A078322

001

Jun 28, 2010

ANILERIDINE HYDROCHLORIDE
TABLET; ORAL LERITINE MERCK

EQ 25MG BASE

N010585

002

ANILERIDINE PHOSPHATE
INJECTABLE; INJECTION LERITINE MERCK

25MG/ML

N010520

003

ANISINDIONE
TABLET; ORAL MIRADON SCHERING

50MG

N010909

003

ANISOTROPINE METHYLBROMIDE
TABLET; ORAL ANISOTROPINE METHYLBROMIDE WATSON LABS 50MG VALPIN 50 ENDO PHARMS 50MG

A086046 N013428

001 001

ANTAZOLINE PHOSPHATE; NAPHAZOLINE HYDROCHLORIDE

SOLUTION/DROPS; OPHTHALMIC VASOCON-A NOVARTIS 0.5%;0.05%

N018746

002

Jul 11, 1994

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

APOMORPHINE HYDROCHLORIDE
INJECTABLE; SUBCUTANEOUS APOKYN US WORLDMEDS

6 - 32 (of 346)

20MG/2ML (10MG/ML)

N021264

001

Apr 20, 2004

ARBUTAMINE HYDROCHLORIDE
INJECTABLE; INJECTION GENESA GENSIA AUTOMEDICS

0.05MG/ML

N020420

001

Sep 12, 1997

ARDEPARIN SODIUM
INJECTABLE; INJECTION NORMIFLO PHARMACIA AND UPJOHN

5,000 UNITS/0.5ML 10,000 UNITS/0.5ML

N020227 N020227

002 001

May 23, 1997 May 23, 1997

ARGATROBAN
SOLUTION; IV (INFUSION) ARGATROBAN IN DEXTROSE SANDOZ

125MG/125ML (1MG/ML)

N201743

001

May 09, 2011

ARIPIPRAZOLE
TABLET, ORALLY DISINTEGRATING; ORAL ABILIFY OTSUKA 20MG 30MG

N021729 N021729

004 005

Jun 07, 2006 Jun 07, 2006

ARMODAFINIL
TABLET; ORAL NUVIGIL CEPHALON

100MG 200MG

N021875 N021875

002 005

Mar 26, 2009 Mar 26, 2009

ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE; VITAMIN E
INJECTABLE; INJECTION BEROCCA PN ROCHE

50MG/ML;0.03MG/ML;0.0025MG/ML;7.5MG/ML; N006071 100 IU/ML;0.2MG/ML;20MG/ML;2MG/ML;1.8MG/ML; 1.5MG/ML;1,650 IU/ML;5 IU/ML

003

Oct 10, 1985

ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E
INJECTABLE; INJECTION M.V.C. 9+3 ABRAXIS PHARM

10MG/ML;0.006MG/ML;0.5MCG/ML;1.5MG/ML;2 N018440 0 IU/ML;0.04MG/ML;4MG/ML;0.4MG/ML;0.36MG/ ML;0.3MG/ML;330 UNITS/ML;1 IU/ML 10MG/ML;0.006MG/ML;0.5MCG/ML;1.5MG/ML;2 N008809 0 IU/ML;0.04MG/ML;4MG/ML;0.4MG/ML;0.36MG/ ML;0.3MG/ML;330 UNITS/ML;1 IU/ML 10MG/ML;0.006MG/ML;0.5MCG/ML;1.5MG/ML;2 N018439 0 IU/ML;0.04MG/ML;4MG/ML;0.4MG/ML;0.36MG/ ML;0.3MG/ML;330 UNITS/ML;1 IU/ML

002

Aug 08, 1985

M.V.I.-12 HOSPIRA

004

Aug 08, 1985

MVC PLUS WATSON LABS

002

Aug 08, 1985

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 33 (of 346)

ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E
INJECTABLE; INJECTION

M.V.I.-12

HOSPIRA

20MG/ML;0.006MG/ML;0.5MCG/ML;1.5MG/ML;2 N008809 0 IU/ML;0.6MG/ML;4MG/ML;0.4MG/ML;0.36MG/M L;0.6MG/ML;330 UNITS/ML;1 IU/ML

005

Apr 22, 2004

ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE; VITAMIN A; VITAMIN E

INJECTABLE; INJECTION

M.V.I.-12 LYOPHILIZED
ASTRAZENECA

100MG/VIAL;0.06MG/VIAL;0.005MG/VIAL;15M N018933 G/VIAL;5MCG/VIAL;0.4MG/VIAL;40MG/VIAL;4 MG/VIAL;3.6MG/VIAL;3MG/VIAL;1MG/VIAL;10 MG/VIAL

002

Aug 08, 1985

ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PANTOTHENIC ACID; PHYTONADIONE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; VITAMIN A PALMITATE; VITAMIN E

INJECTABLE; INJECTION

VITAPED
HOSPIRA

N/A,80MG/VIAL;N/A,0.02MG/VIAL;N/A,0.001 N020176 MG/VIAL;400 IU/10ML,N/A;N/A,0.14MG/VIAL;N/A,17MG/VI AL;N/A,5MG/VIAL;0.2MG/10ML,N/A;N/A,1MG/ VIAL;N/A,1.4MG/VIAL;N/A,1.2MG/VIAL;EQ 2,300 UNITS BASE/10ML,N/A;7 IU/10ML,N/A

001

Dec 29, 1993

ASPIRIN
TABLET; ORAL BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN BAYER 500MG TABLET, EXTENDED RELEASE; ORAL 8-HOUR BAYER BAYER 650MG MEASURIN BAYER 650MG

N021317

001

Oct 18, 2001

N016030 N016030

001 002

ASPIRIN; BUTALBITAL
TABLET; ORAL AXOTAL SAVAGE LABS

650MG;50MG

A088305

001

Oct 13, 1983

ASPIRIN; BUTALBITAL; CAFFEINE

CAPSULE; ORAL BUTALBITAL, ASPIRIN AND CAFFEINE MUTUAL PHARM 325MG;50MG;40MG WATSON LABS 325MG;50MG;40MG TABLET; ORAL BUTALBITAL, ASPIRIN AND CAFFEINE ACTAVIS ELIZABETH 325MG;50MG;40MG HALSEY 325MG;50MG;40MG IVAX PHARMS 325MG;50MG;40MG PURACAP PHARM 325MG;50MG;40MG QUANTUM PHARMICS 325MG;50MG;40MG SANDOZ 325MG;50MG;40MG WATSON LABS 325MG;50MG;40MG FIORINAL WATSON LABS INC 325MG;50MG;40MG LANORINAL LANNETT 325MG;50MG;40MG

A078149 A086231

001 002

Jun 13, 2007 Feb 12, 1985

A086710 A089448 A085441 A087048 A088972 A086398 A086237 N017534 A086986

002 001 002 002 001 002 002 003 002

Aug Dec Oct Dec Jun Apr Mar

23, 01, 31, 09, 18, 06, 23,

1983 1986 1984 1983 1985 1984 1984

Apr 16, 1986 Oct 18, 1985

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
CAPSULE; ORAL BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE ENDO PHARMS 325MG;50MG;40MG;30MG

6 - 34 (of 346)

A075351

001

Mar 05, 1999

ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE

TABLET; ORAL ORPHENGESIC SOLCO HLTHCARE ORPHENGESIC FORTE SOLCO HLTHCARE

385MG;30MG;25MG 770MG;60MG;50MG

A075141 A075141

001 002

May 29, 1998 May 29, 1998

ASPIRIN; CAFFEINE; PROPOXYPHENE HYDROCHLORIDE

CAPSULE; ORAL COMPOUND 65 ALRA 389MG;32.4MG;65MG DARVON COMPOUND XANODYNE PHARM 389MG;32.4MG;32MG DARVON COMPOUND-65 XANODYNE PHARM 389MG;32.4MG;65MG PROPOXYPHENE COMPOUND 65 IVAX SUB TEVA PHARMS 389MG;32.4MG;65MG SANDOZ 389MG;32.4MG;65MG TEVA 389MG;32.4MG;65MG PROPOXYPHENE COMPOUND-65 SANDOZ 389MG;32.4MG;65MG PROPOXYPHENE HYDROCHLORIDE W/ ASPIRIN AND CAFFEINE WATSON LABS 389MG;32.4MG;65MG

A084553 N010996 N010996 A083077 A080044 A089025 A083101 A085732

002 006 007 002 002 001 002 002

Aug 17, 1983 Mar 08, 1983 Mar 08, 1983 Dec 07, 1984 Sep 16, 1983 Mar 29, 1985 Jun 24, 1985 Sep 03, 1984

ASPIRIN; CARISOPRODOL
TABLET; ORAL CARISOPRODOL COMPOUND WATSON LABS

325MG;200MG

A088809

001

Oct 03, 1985

ASPIRIN; HYDROCODONE BITARTRATE

TABLET; ORAL AZDONE SCHWARZ PHARMA VICOPRIN ABBOTT

500MG;5MG 500MG;5MG

A089420 A086333

001 001

Jan 25, 1988 Sep 14, 1983

ASPIRIN; MEPROBAMATE
TABLET; ORAL EQUAGESIC CARACO MEPRO-ASPIRIN SANDOZ MEPROBAMATE AND ASPIRIN PAR PHARM MICRAININ MEDPOINTE PHARM HLC Q-GESIC QUANTUM PHARMICS

325MG;200MG 325MG;200MG 325MG;200MG 325MG;200MG 325MG;200MG

N011702 A089127 A089126 A084978 A088740

003 001 001 001 001

Dec 29, 1983 Mar 02, 1987 Aug 19, 1986

Jun 01, 1984

ASPIRIN; METHOCARBAMOL
TABLET; ORAL METHOCARBAMOL AND ASPIRIN IVAX SUB TEVA PHARMS 325MG;400MG MCNEIL 325MG;400MG PAR PHARM 325MG;400MG ROBAXISAL ROBINS AH 325MG;400MG

A087211 A089193 A089657 N012281

001 001 001 001

Dec 22, 1982 Feb 12, 1986 Nov 04, 1988

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE
TABLET; ORAL CODOXY HALSEY OXYCODONE AND ASPIRIN MUTUAL PHARM

6 - 35 (of 346)

325MG;4.5MG;0.38MG

A087464 A040260 A087794 A087742 N007337 N007337 A087743

001 001 001 001 006 005 001

Jul 01, 1982 Jul 17, 1998 May 26, 1982 Jun 04, 1982

325MG;4.5MG;0.38MG 325MG;4.5MG;0.38MG OXYCODONE AND ASPIRIN (HALF-STRENGTH) ROXANE 325MG;2.25MG;0.19MG PERCODAN ENDO PHARMS 325MG;4.5MG;0.38MG PERCODAN-DEMI ENDO PHARMS 325MG;2.25MG;0.19MG ROXIPRIN ROXANE 325MG;4.5MG;0.38MG

Jun 04, 1982

ASPIRIN; PENTAZOCINE HYDROCHLORIDE

TABLET; ORAL TALWIN COMPOUND SANOFI AVENTIS US

325MG;EQ 12.5MG BASE

N016891

001

ASPIRIN; PRAVASTATIN SODIUM

TABLET, TABLET; ORAL PRAVIGARD PAC (COPACKAGED) BRISTOL MYERS SQUIBB 325MG,N/A;N/A,80MG TABLET, TABLET, TABLET; ORAL PRAVIGARD PAC (COPACKAGED) BRISTOL MYERS SQUIBB 81MG,N/A;N/A,20MG 81MG,N/A;N/A,40MG 81MG,N/A;N/A,80MG 325MG,N/A;N/A,20MG 325MG,N/A;N/A,40MG

N021387

006

Jun 24, 2003

N021387 N021387 N021387 N021387 N021387

001 002 003 004 005

Jun Jun Jun Jun Jun

24, 24, 24, 24, 24,

2003 2003 2003 2003 2003

ASPIRIN; PROPOXYPHENE HYDROCHLORIDE

CAPSULE; ORAL DARVON W/ ASA XANODYNE PHARM

325MG;65MG

N010996

005

ASPIRIN; PROPOXYPHENE NAPSYLATE

CAPSULE; ORAL DARVON-N W/ AAIPHARMA TABLET; ORAL DARVON-N W/ AAIPHARMA ASA LLC ASA LLC

325MG;100MG

N016829

001

325MG;100MG

N016863

001

ATENOLOL
INJECTABLE; INJECTION TENORMIN ASTRAZENECA TABLET; ORAL ATENOLOL ABLE

0.5MG/ML

N019058

001

Sep 13, 1989

APOTHECON NOSTRUM LABS PLIVA

SANDOZ

25MG 50MG 100MG 50MG 100MG 50MG 100MG 25MG 50MG 100MG 25MG

A076907 A076907 A076907 A073317 A073318 A074127 A074127 A074101 A074101 A074101 A074265

001 002 003 001 001 001 002 001 002 003 001

Jul Jul Jul Mar Mar Feb Feb Jul Jul Jul Feb

30, 30, 30, 20, 20, 21, 21, 17, 17, 17, 28,

2004 2004 2004 1992 1992 1995 1995 1997 1997 1997 1994

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

ATENOLOL
TABLET; ORAL ATENOLOL SANDOZ SCS TEVA TEVA PHARMS

6 - 36 (of 346)

50MG 100MG 50MG 100MG 50MG 100MG 50MG 100MG

A074265 A074265 A073676 A073676 A073315 A073316 A074120 A074120

002 003 001 002 001 001 001 002

Feb Feb Oct Oct May May Feb Feb

28, 28, 30, 30, 28, 28, 24, 24,

1994 1994 1992 1992 1993 1993 1995 1995

ATENOLOL; CHLORTHALIDONE
TABLET; ORAL ATENOLOL AND CHLORTHALIDONE NOSTRUM LABS 50MG;25MG 100MG;25MG PLIVA 50MG;25MG 100MG;25MG

A074404 A074404 A074107 A074107

001 002 001 002

May May Sep Sep

14, 14, 24, 24,

1998 1998 1997 1997

ATOMOXETINE HYDROCHLORIDE
CAPSULE; ORAL ATOMOXETINE HYDROCHLORIDE ACTAVIS ELIZABETH 10MG 18MG 25MG 40MG 60MG 80MG 100MG STRATTERA LILLY 5MG

A078940 A078940 A078940 A078940 A078940 A078940 A078940 N021411

001 002 003 004 005 006 007 001

Aug Aug Aug Aug Aug Aug Aug

30, 30, 30, 30, 30, 30, 30,

2010 2010 2010 2010 2010 2010 2010

Nov 26, 2002

ATOVAQUONE
TABLET; ORAL MEPRON GLAXOSMITHKLINE LLC

250MG

N020259

001

Nov 25, 1992

ATRACURIUM BESYLATE
INJECTABLE; INJECTION ATRACURIUM BESYLATE BAXTER HLTHCARE BAXTER HLTHCARE CORP HOSPIRA

10MG/ML 10MG/ML 10MG/ML 10MG/ML MARSAM PHARMS LLC 10MG/ML TEVA PARENTERAL 10MG/ML ATRACURIUM BESYLATE PRESERVATIVE FREE BAXTER HLTHCARE 10MG/ML BAXTER HLTHCARE CORP 10MG/ML HOSPIRA 10MG/ML 10MG/ML 10MG/ML MARSAM PHARMS LLC 10MG/ML TRACRIUM HOSPIRA 10MG/ML TRACRIUM PRESERVATIVE FREE HOSPIRA 10MG/ML

A074824 A074753 A074632 A074740 A074945 A074784 A074825 A074768 A074633 A074639 A074741 A074944 N018831 N018831

001 001 001 001 001 001 001 001 001 001 001 001 002 001

Sep Jan Dec Mar Jul Jun Sep Jan Dec Mar Mar Jul

30, 23, 23, 28, 28, 11, 30, 23, 23, 25, 28, 28,

1997 1997 1996 1997 1998 1997 1997 1997 1996 1997 1997 1998

Jun 20, 1985 Nov 23, 1983

ATROPINE
INJECTABLE; INJECTION ATROPINE SOLVAY

EQ 2MG SULFATE/0.7ML

A071295

001

Jan 30, 1987

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

ATROPINE SULFATE
AEROSOL, METERED; INHALATION ATROPINE SULFATE US ARMY EQ 0.36MG BASE/INH

6 - 37 (of 346)

N020056

001

Sep 19, 1990

ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE

TABLET; ORAL MOTOFEN HALF-STRENGTH VALEANT

0.025MG;0.5MG

N017744

001

ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE

CAPSULE; ORAL DIPHENOXYLATE HYDROCHLORIDE W/ ATROPINE SULFATE SCHERER RP 0.025MG;2.5MG SOLUTION; ORAL COLONAID MEDPOINTE PHARM HLC 0.025MG/5ML;2.5MG/5ML LOMANATE ALPHARMA US PHARMS 0.025MG/5ML;2.5MG/5ML TABLET; ORAL COLONAID MEDPOINTE PHARM HLC 0.025MG;2.5MG DI-ATRO MD PHARM 0.025MG;2.5MG DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE ABLE 0.025MG;2.5MG ASCOT 0.025MG;2.5MG HEATHER 0.025MG;2.5MG INWOOD LABS 0.025MG;2.5MG IVAX PHARMS 0.025MG;2.5MG KV PHARM 0.025MG;2.5MG LEDERLE 0.025MG;2.5MG MUTUAL PHARM 0.025MG;2.5MG PARKE DAVIS 0.025MG;2.5MG PVT FORM 0.025MG;2.5MG R AND S PHARMA 0.025MG;2.5MG ROXANE 0.025MG;2.5MG SANDOZ 0.025MG;2.5MG USL PHARMA 0.025MG;2.5MG VALEANT PHARM INTL 0.025MG;2.5MG WATSON LABS 0.025MG;2.5MG WEST WARD 0.025MG;2.5MG LOGEN SUPERPHARM 0.025MG;2.5MG LO-TROL VANGARD 0.025MG;2.5MG LOW-QUEL HALSEY 0.025MG;2.5MG

A086440

001

A085735 A085746

001 001

A085737 A085266 A040395 A087934 A086798 A085509 A086727 A085659 A086950 A085506 A087131 A085766 A085035 A086057 A086173 A087842 A087195 A085876 A087765 A088962 A088009 A085211

001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 Nov 27, 2000 Jul 19, 1983

Mar 29, 1982 Feb 16, 1982 Mar 15, 1982 May 10, 1985 Mar 25, 1983

ATROPINE SULFATE; EDROPHONIUM CHLORIDE

INJECTABLE; INJECTION ENLON-PLUS MYLAN INSTITUTIONAL

0.14MG/ML;10MG/ML

N019677

001

Nov 06, 1991

ATROPINE SULFATE; MEPERIDINE HYDROCHLORIDE

INJECTABLE; INJECTION ATROPINE AND DEMEROL ABBOTT

0.4MG/ML;50MG/ML 0.4MG/ML;75MG/ML 0.4MG/ML;100MG/ML MEPERIDINE AND ATROPINE SULFATE WYETH AYERST 0.4MG/ML;50MG/ML 0.4MG/ML;75MG/ML

A087853 A087847 A087848 A085121 A085121

001 001 001 001 002

Nov 26, 1982 Nov 26, 1982 Nov 26, 1982

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

ATROPINE SULFATE; MEPERIDINE HYDROCHLORIDE
INJECTABLE; INJECTION MEPERIDINE AND ATROPINE SULFATE WYETH AYERST 0.4MG/ML;100MG/ML

6 - 38 (of 346)

A085121

003

ATROPINE; PRALIDOXIME CHLORIDE

INJECTABLE; INTRAMUSCULAR ATNAA US ARMY 2.1MG/0.7ML;600MG/0.7ML

N021175

001

Jan 17, 2002

AZATADINE MALEATE
TABLET; ORAL OPTIMINE SCHERING

1MG

N017601

001

AZATADINE MALEATE; PSEUDOEPHEDRINE SULFATE

TABLET, EXTENDED RELEASE; ORAL TRINALIN SCHERING 1MG;120MG

N018506

001

Mar 23, 1982

AZATHIOPRINE
TABLET; ORAL IMURAN PROMETHEUS LABS

25MG

N016324

002

AZATHIOPRINE SODIUM
INJECTABLE; INJECTION IMURAN PROMETHEUS LABS

EQ 100MG BASE/VIAL

N017391

001

AZELASTINE HYDROCHLORIDE
SPRAY, METERED; NASAL ASTEPRO MEDA PHARMS

EQ 0.125MG BASE/SPRAY

N022203

001

Oct 15, 2008

AZITHROMYCIN
CAPSULE; ORAL ZITHROMAX PFIZER

EQ 250MG BASE

N050670

001

Nov 01, 1991

AZITHROMYCIN DIHYDRATE; TROVAFLOXACIN MESYLATE

FOR SUSPENSION, TABLET; ORAL TROVAN/ZITHROMAX COMPLIANCE PAK PFIZER EQ 1GM BASE,N/A;N/A,EQ 100MG BASE

N050762

001

Dec 18, 1998

AZLOCILLIN SODIUM
INJECTABLE; INJECTION AZLIN BAYER PHARMS

EQ EQ EQ EQ EQ EQ EQ EQ EQ

2GM 2GM 2GM 3GM 3GM 3GM 4GM 4GM 4GM

BASE/VIAL BASE/VIAL BASE/VIAL BASE/VIAL BASE/VIAL BASE/VIAL BASE/VIAL BASE/VIAL BASE/VIAL

A062388 A062417 N050562 A062388 A062417 N050562 A062388 A062417 N050562

001 001 001 002 002 002 003 003 003

Sep Oct Sep Sep Oct Sep Sep Oct Sep

08, 12, 03, 08, 12, 03, 08, 12, 03,

1982 1982 1982 1982 1982 1982 1982 1982 1982

AZTREONAM
INJECTABLE; INJECTION AZACTAM BRISTOL MYERS SQUIBB

500MG/VIAL

N050580

001

Dec 31, 1986

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

AZTREONAM
INJECTABLE; INJECTION AZACTAM IN PLASTIC CONTAINER BRISTOL MYERS SQUIBB 10MG/ML

6 - 39 (of 346)

N050632

003

May 24, 1989

BACAMPICILLIN HYDROCHLORIDE
FOR SUSPENSION; ORAL SPECTROBID PFIZER TABLET; ORAL SPECTROBID PFIZER

125MG/5ML

N050556

001

Mar 23, 1982

400MG 800MG

N050520 N050520

001 002

Sep 12, 1983

BACITRACIN
INJECTABLE; INJECTION BACITRACIN PFIZER 50,000 UNITS/VIAL OINTMENT; OPHTHALMIC BACIGUENT PHARMACIA AND UPJOHN 500 UNITS/GM BACITRACIN LILLY 500 UNITS/GM PHARMADERM 500 UNITS/GM PHARMAFAIR 500 UNITS/GM OINTMENT; TOPICAL BACITRACIN COMBE 500 UNITS/GM NASKA 500 UNITS/GM POWDER; FOR RX COMPOUNDING BACITRACIN APOTHEKERNES 5,000,000 UNITS/BOT PADDOCK LLC 5,000,000 UNITS/BOT

A060282

001

A060734 A060687 A062158 A062453

001 001 001 001

Mar 28, 1984

A062799 A062857

001 001

May 14, 1987 Nov 13, 1987

A061699 A062456

001 001

Jul 27, 1983

BACITRACIN ZINC
POWDER; FOR RX COMPOUNDING

ZIBA-RX

X GEN PHARMS 500,000 UNITS/BOT

A061737

001

BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

OINTMENT; OPHTHALMIC
CORTISPORIN
MONARCH PHARMS

400 UNITS/GM;1%;EQ 3.5MG N050416 BASE/GM;10,000 UNITS/GM

ZINC BACITRACIN,NEOMYCIN SULFATE,POLYMYXIN B SULFATE & HYDROCORTISONE
PHARMAFAIR 400 UNITS/GM;1%;EQ 3.5MG A062389 BASE/GM;10,000 UNITS/GM OINTMENT; TOPICAL NEOMYCIN & POLYMYXIN B SULFATES & BACITRACIN ZINC & HYDROCORTISONE PHARMAFAIR 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 A062381 UNITS/GM

002

001

Jul 02, 1982

001

Sep 06, 1985

BACITRACIN ZINC; LIDOCAINE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

OINTMENT; TOPICAL LANABIOTIC COMBE

400 UNITS/GM;40MG/GM;EQ 5MG BASE/GM;5,000 UNITS/GM

A062499

001

Jun 03, 1985

BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

OINTMENT; OPHTHALMIC BACITRACIN ZINC-NEOMYCIN SULFATE-POLYMYXIN B SULFATE PHARMAFAIR 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM

A062386

001

Sep 09, 1982

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
OINTMENT; OPHTHALMIC
BACITRACIN-NEOMYCIN-POLYMYXIN
PHARMADERM 400 UNITS/GM;EQ 3.5MG BASE/GM;5,000 UNITS/GM
NEO-POLYCIN
DOW PHARM 500 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM
NEOSPORIN
MONARCH PHARMS 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM
OINTMENT; TOPICAL
BACITRACIN ZINC-NEOMYCIN SULFATE-POLYMYXIN B SULFATE
NASKA 400 UNITS/GM;EQ 3.5MG BASE/GM;5,000 UNITS/GM

6 - 40 (of 346)

A062167

001

A060647

001

N050417

001

A062833

001

Nov 09, 1987

BACITRACIN ZINC; POLYMYXIN B SULFATE

AEROSOL; TOPICAL POLYSPORIN GLAXOSMITHKLINE 10,000 UNITS/GM;2,000,000 UNITS/GM OINTMENT; OPHTHALMIC OCUMYCIN PHARMAFAIR 500 UNITS/GM;10,000 UNITS/GM POLYSPORIN MONARCH PHARMS 500 UNITS/GM;10,000 UNITS/GM OINTMENT; TOPICAL BACITRACIN ZINC-POLYMYXIN B SULFATE NASKA 500 UNITS/GM;10,000 UNITS/GM

N050167

002

Mar 01, 1985

A062430 A061229

001 001

Apr 08, 1983

A062849

001

Nov 13, 1987

BACITRACIN; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

OINTMENT; OPHTHALMIC

BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE
ALTANA 400 UNITS/GM;1%;EQ 3.5MG
BASE/GM;10,000 UNITS/GM

A060731

002

BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

OINTMENT; OPHTHALMIC

MYCITRACIN

PHARMACIA AND UPJOHN

500 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM

A061048

001

BACITRACIN; POLYMYXIN B SULFATE

DISC; TOPICAL LANABIOTIC COMBE

500 UNITS/GM;5,000 UNITS/GM

N050598

001

Sep 22, 1986

BACLOFEN
TABLET; ORAL BACLOFEN TEVA USL PHARMA WATSON LABS

10MG 20MG 10MG 20MG 10MG 10MG 20MG 20MG

A073043 A073044 A071260 A071261 A073092 A074698 A073093 A074698 N017851 N017851

001 001 001 001 001 001 001 002 001 003

Feb Feb May May Jan Aug Jan Aug

27, 27, 06, 06, 28, 20, 28, 20,

1992 1992 1988 1988 1994 1996 1994 1996

10MG 20MG TABLET, ORALLY DISINTEGRATING; ORAL KEMSTRO SCHWARZ PHARMA 10MG 20MG

LIORESAL NOVARTIS

Jan 20, 1982

N021589 N021589

001 002

Oct 30, 2003 Oct 30, 2003

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

BECLOMETHASONE DIPROPIONATE
AEROSOL, METERED; INHALATION BECLOVENT GLAXOSMITHKLINE 0.042MG/INH VANCERIL SCHERING 0.042MG/INH VANCERIL DOUBLE STRENGTH SCHERING 0.084MG/INH AEROSOL, METERED; NASAL BECONASE GLAXOSMITHKLINE 0.042MG/INH VANCENASE SCHERING 0.042MG/INH

6 - 41 (of 346)

N018153 N017573 N020486

001 001 001 Dec 24, 1996

N018584 N018521

001 001

BECLOMETHASONE DIPROPIONATE MONOHYDRATE

SPRAY, METERED; NASAL VANCENASE AQ SCHERING

EQ 0.042MG DIPROP/SPRAY EQ 0.084MG DIPROP/SPRAY

N019589 N020469

001 001

Dec 23, 1987 Jun 26, 1996

BENAZEPRIL HYDROCHLORIDE
TABLET; ORAL BENAZEPRIL HYDROCHLORIDE GENPHARM 5MG 10MG 20MG 40MG

A076476 A076476 A076476 A076476

001 002 003 004

Feb Feb Feb Feb

11, 11, 11, 11,

2004 2004 2004 2004

BENDROFLUMETHIAZIDE
TABLET; ORAL NATURETIN-10 APOTHECON NATURETIN-2.5 APOTHECON NATURETIN-5 APOTHECON

10MG 2.5MG 5MG

N012164 N012164 N012164

003 001 002

BENOXINATE HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC BENOXINATE HYDROCHLORIDE SOLA BARNES HIND 0.4%

A084149

001

BENTIROMIDE
SOLUTION; ORAL CHYMEX SAVAGE LABS

500MG/7.5ML

N018366

001

Dec 29, 1983

BENZPHETAMINE HYDROCHLORIDE
TABLET; ORAL DIDREX PHARMACIA AND UPJOHN

25MG

N012427

003

BENZQUINAMIDE HYDROCHLORIDE
INJECTABLE; INJECTION
EMETE-CON
PFIZER SUPPOSITORY; RECTAL
EMETE-CON
ROERIG

EQ 50MG BASE/VIAL

N016820

001

EQ 100MG BASE

N016818

006

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

BENZTHIAZIDE
TABLET; ORAL AQUATAG SOLVAY BENZTHIAZIDE PVT FORM EXNA AH ROBINS INC FOVANE PFIZER URESE PFIZER

6 - 42 (of 346)

25MG 50MG 50MG 50MG 50MG 25MG

N016001 N016001 A083206 N012489 N012128 N012128

001 002 001 001 002 003

BENZTROPINE MESYLATE
TABLET; ORAL BENZTROPINE MESYLATE ACTAVIS TOTOWA

MUTUAL PHARM QUANTUM PHARMICS

USL PHARMA

0.5MG 1MG 2MG 1MG 2MG 0.5MG 1MG 2MG 0.5MG 1MG 2MG 0.5MG 1MG 2MG

A040699 A040705 A040706 A081264 A081265 A088514 A088510 A088511 A089211 A089212 A089213 N009193 N009193 N009193

001 001 001 001 001 001 001 001 001 001 001 004 003 002

Feb Feb Feb Jan Jan Jan Jan Jan Jun Jun Jun

14, 14, 14, 23, 23, 31, 31, 31, 14, 14, 14,

2008 2008 2008 1992 1992 1984 1984 1984 1988 1988 1988

COGENTIN MERCK

BENZYL BENZOATE
EMULSION; TOPICAL BENZYL BENZOATE LANNETT

50%

A084535

001

BEPRIDIL HYDROCHLORIDE
TABLET; ORAL BEPADIN MEDPOINTE PHARM HLC

200MG 300MG 400MG 200MG 300MG 400MG

N019001 N019001 N019001 N019002 N019002 N019002

001 002 003 001 002 003

Dec 28, 1990 Dec 28, 1990 Dec 28, 1990 Dec 28, 1990 Dec 28, 1990 Dec 28, 1990

VASCOR JOHNSON AND JOHNSON

BETA CAROTENE
CAPSULE; ORAL SOLATENE ROCHE

30MG

N017589

001

BETAMETHASONE
CREAM; TOPICAL CELESTONE SCHERING TABLET; ORAL CELESTONE SCHERING

0.2%

N014762

001

0.6MG

N012657

003

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

BETAMETHASONE BENZOATE
CREAM; TOPICAL UTICORT PARKE DAVIS GEL; TOPICAL UTICORT PARKE DAVIS LOTION; TOPICAL UTICORT PARKE DAVIS OINTMENT; TOPICAL UTICORT PARKE DAVIS

6 - 43 (of 346)

0.025%

N016998

002

0.025%

N017244

001

0.025%

N017528

001

0.025%

N018089

001

BETAMETHASONE DIPROPIONATE
CREAM; TOPICAL ALPHATREX SAVAGE LABS EQ 0.05% BASE BETAMETHASONE DIPROPIONATE PERRIGO NEW YORK EQ 0.05% BASE EQ 0.05% BASE PHARMADERM EQ 0.05% BASE TARO EQ 0.05% BASE TEVA EQ 0.05% BASE DIPROSONE SCHERING EQ 0.05% BASE CREAM, AUGMENTED; TOPICAL DIPROLENE SCHERING EQ 0.05% BASE DISC; TOPICAL DIPROSONE SCHERING EQ 0.1% BASE GEL, AUGMENTED; TOPICAL DIPROLENE SCHERING EQ 0.05% BASE LOTION; TOPICAL ALPHATREX SAVAGE LABS EQ 0.05% BASE BETAMETHASONE DIPROPIONATE ALPHARMA US PHARMS EQ 0.05% BASE PHARMADERM EQ 0.05% BASE TARO EQ 0.05% BASE EQ 0.05% BASE TEVA PHARMS EQ 0.05% BASE DIPROSONE SCHERING EQ 0.05% BASE OINTMENT; TOPICAL ALPHATREX SAVAGE LABS EQ 0.05% BASE BETAMETHASONE DIPROPIONATE PERRIGO NEW YORK EQ 0.05% BASE PHARMADERM EQ 0.05% BASE TEVA EQ 0.05% BASE DIPROSONE SCHERING EQ 0.05% BASE

N019138 A072536 A074579 N019136 A071143 A071476 N017536

001 001 001 001 001 001 001

Jun 26, 1984 Jan Nov Jun Jun Aug 31, 26, 26, 17, 10, 1990 1997 1984 1987 1987

N019408

001

Jan 31, 1986

N017829

001

N019408

002

Nov 22, 1991

A070273 A071085 A070274 A072276 A074272 A071882 N017781

001 001 001 001 001 001 001

Aug 12, 1985 Feb Aug Aug Sep Jun 03, 12, 24, 30, 06, 1987 1985 1988 1994 1988

N019143 A072526 N019140 A071477 N017691

001 001 001 001 001

Sep 04, 1984 Jan 31, 1990 Sep 04, 1984 Aug 10, 1987

BETAMETHASONE SODIUM PHOSPHATE

INJECTABLE; INJECTION BETAMETHASONE SODIUM PHOSPHATE WATSON LABS EQ 3MG BASE/ML CELESTONE SCHERING EQ 3MG BASE/ML

A085738 N017561

001 001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

BETAMETHASONE VALERATE
CREAM; TOPICAL BETADERM ROACO BETAMETHASONE VALERATE PERRIGO NEW YORK PHARMADERM PHARMAFAIR TARO BETATREX SAVAGE LABS VALISONE SCHERING LOTION; TOPICAL BETAMETHASONE VALERATE PHARMADERM PHARMAFAIR TEVA PHARMS BETATREX SAVAGE LABS VALISONE SCHERING OINTMENT; TOPICAL BETAMETHASONE VALERATE PERRIGO NEW YORK PHARMADERM PHARMAFAIR BETATREX SAVAGE LABS BETA-VAL TEVA VALISONE SCHERING

6 - 44 (of 346)

EQ 0.1% BASE EQ EQ EQ EQ 0.1% 0.1% 0.1% 0.1% BASE BASE BASE BASE

N018839 A070053 N018860 A070485 A070062 N018862 N016322 N016322

001 001 002 001 001 001 002 001

Jun 30, 1983 Jun Aug May May 10, 31, 29, 14, 1986 1983 1987 1985

EQ 0.1% BASE EQ 0.01% BASE EQ 0.1% BASE

Aug 31, 1983

EQ 0.1% BASE EQ 0.1% BASE EQ 0.1% BASE EQ 0.1% BASE EQ 0.1% BASE

N018870 A070484 A071883 N018867 N016932

001 001 001 001 001

Aug 31, 1983 May 29, 1987 Apr 22, 1988 Aug 31, 1983

EQ 0.1% BASE EQ 0.1% BASE EQ 0.1% BASE EQ 0.1% BASE EQ 0.1% BASE EQ 0.1% BASE

A071478 N018864 A070486 N018863 A070069 N016740

001 001 001 001 001 001

Dec 23, 1987 Aug 31, 1983 May 29, 1987 Aug 31, 1983 Dec 19, 1985

BETAXOLOL HYDROCHLORIDE
TABLET; ORAL KERLONE SANOFI AVENTIS US

10MG 20MG

N019507 N019507

001 002

Oct 27, 1989 Oct 27, 1989

BETAXOLOL HYDROCHLORIDE; CHLORTHALIDONE

TABLET; ORAL KERLEDEX SANOFI AVENTIS US

5MG;12.5MG 10MG;12.5MG

N019807 N019807

001 002

Oct 30, 1992 Oct 30, 1992

BETAXOLOL HYDROCHLORIDE; PILOCARPINE HYDROCHLORIDE

SUSPENSION/DROPS; OPHTHALMIC BETOPTIC PILO ALCON EQ 0.25% BASE;1.75%

N020619

001

Apr 17, 1997

BETAZOLE HYDROCHLORIDE
INJECTABLE; INJECTION HISTALOG LILLY

50MG/ML

N009344

001

BETHANECHOL CHLORIDE
INJECTABLE; INJECTION URECHOLINE ODYSSEY PHARMS

5MG/ML

N006536

001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

BETHANECHOL CHLORIDE
TABLET; ORAL BETHANECHOL CHLORIDE ABLE

6 - 45 (of 346)

ACTAVIS TOTOWA

ASCOT IVAX SUB TEVA PHARMS LANNETT

SANDOZ

WATSON LABS

5MG 10MG 25MG 50MG 5MG 10MG 25MG 50MG 10MG 25MG 25MG 5MG 10MG 25MG 5MG 10MG 10MG 25MG 25MG 5MG 5MG 5MG 10MG 10MG 10MG 25MG 25MG 25MG 50MG 50MG 5MG 10MG 25MG 5MG 10MG 25MG 50MG

A040492 A040483 A040485 A040509 A040552 A040553 A040554 A040551 A088288 A088289 A084689 A084702 A084712 A084074 A084353 A084378 A084379 A084383 A084384 A084402 A085230 A085841 A084408 A085228 A085842 A084441 A085229 A085839 A087397 A087444 A084188 A084188 A084188 N006536 N006536 N006536 N006536

001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 002 001 001 001 001 001 001 001 001 001 001 003 004 003 002 004 005

Jul Jul Jul Jul Oct Oct Oct Oct Jun Jun

27, 27, 27, 27, 28, 28, 28, 28, 08, 08,

2004 2004 2004 2004 2004 2004 2004 2004 1983 1983

MYOTONACHOL GLENWOOD

URECHOLINE ODYSSEY PHARMS

BETHANIDINE SULFATE
TABLET; ORAL TENATHAN ROBINS AH

10MG 25MG

N017675 N017675

001 002

BIPERIDEN LACTATE
INJECTABLE; INJECTION AKINETON ABBOTT

5MG/ML

N012418

002

BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
FOR SOLUTION, TABLET, DELAYED RELEASE; ORAL HALFLYTELY BRAINTREE 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM N021551 ;N/A,5.6GM

002

Sep 24, 2007

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

BISOPROLOL FUMARATE
TABLET; ORAL BISOPROLOL FUMARATE MUTUAL PHARM

6 - 46 (of 346)

5MG 10MG

A075474 A075474

001 002

Oct 25, 2002 Oct 25, 2002

BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE

TABLET; ORAL BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE ACTAVIS ELIZABETH 2.5MG;6.25MG 5MG;6.25MG 10MG;6.25MG APOTHECON 2.5MG;6.25MG 5MG;6.25MG 10MG;6.25MG IVAX SUB TEVA PHARMS 2.5MG;6.25MG 5MG;6.25MG 10MG;6.25MG SANDOZ 2.5MG;6.25MG 5MG;6.25MG 10MG;6.25MG TEVA 2.5MG;6.25MG 5MG;6.25MG 10MG;6.25MG

A075672 A075672 A075672 A075642 A075642 A075642 A075632 A075632 A075632 A075527 A075527 A075527 A075686 A075686 A075686

001 002 003 002 001 003 001 002 003 001 003 002 001 002 003

Sep Sep Sep Dec Dec Dec Sep Sep Sep Sep Sep Sep Jan Jan Jan

25, 25, 25, 27, 27, 27, 27, 27, 27, 25, 25, 25, 19, 19, 19,

2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2001 2001 2001

BITOLTEROL MESYLATE
AEROSOL, METERED; INHALATION TORNALATE SANOFI AVENTIS US 0.37MG/INH SOLUTION; INHALATION TORNALATE SANOFI AVENTIS US 0.2%

N018770

001

Dec 28, 1984

N019548

001

Feb 19, 1992

BLEOMYCIN SULFATE
INJECTABLE; INJECTION BLENOXANE BRISTOL MYERS SQUIBB BLEOMYCIN SULFATE TEVA PARENTERAL

EQ 15 UNITS BASE/VIAL EQ 30 UNITS BASE/VIAL EQ 15 UNITS BASE/VIAL EQ 30 UNITS BASE/VIAL

N050443 N050443 A064084 A064084

001 002 001 002

Sep 07, 1995 Jun 01, 1996 Jun 01, 1996

BRETYLIUM TOSYLATE
INJECTABLE; INJECTION BRETYLIUM TOSYLATE ABRAXIS PHARM

50MG/ML 100MG/ML ASTRAZENECA 50MG/ML 50MG/ML 50MG/ML BAXTER HLTHCARE 50MG/ML 50MG/ML HOSPIRA 50MG/ML 50MG/ML INTL MEDICATION 50MG/ML LUITPOLD 50MG/ML BRETYLIUM TOSYLATE IN DEXTROSE 5% ABBOTT 200MG/100ML 400MG/100ML 800MG/100ML BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER BAXTER HLTHCARE 200MG/100ML 400MG/100ML

A070134 A071298 A071151 A071152 A071153 A070545 A070546 N019030 N019033 A070119 A070891 N019005 N019005 N019005 N019837 N019837

001 001 001 001 001 001 001 001 001 001 001 002 003 001 002 001

Apr Feb Aug Aug Aug May May Apr Apr Apr Jul

29, 13, 10, 10, 10, 14, 14, 29, 29, 29, 26,

1986 1987 1987 1987 1987 1986 1986 1986 1986 1986 1988

Apr 29, 1986 Apr 29, 1986 Apr 29, 1986 Apr 12, 1989 Apr 12, 1989

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

BRETYLIUM TOSYLATE
INJECTABLE; INJECTION BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER HOSPIRA INC 200MG/100ML 400MG/100ML 800MG/100ML BRETYLOL HOSPIRA 50MG/ML

6 - 47 (of 346)

N019008 N019008 N019008 N017954

002 003 001 001

Apr 29, 1986 Apr 29, 1986 Apr 29, 1986

BRIMONIDINE TARTRATE
SOLUTION/DROPS; OPHTHALMIC ALPHAGAN ALLERGAN 0.2% 0.5% BRIMONIDINE TARTRATE TEVA PARENTERAL 0.2%

N020613 N020490 A076372

001 001 001

Sep 06, 1996 Mar 13, 1997 Sep 10, 2004

BROMFENAC SODIUM
SOLUTION/DROPS; OPHTHALMIC XIBROM ISTA PHARMS INC 0.09%

N021664

001

Mar 24, 2005

BROMOCRIPTINE MESYLATE
CAPSULE; ORAL BROMOCRIPTINE MESYLATE LEK PHARM

EQ 5MG BASE

A075100

001

Dec 10, 1998

BROMODIPHENHYDRAMINE HYDROCHLORIDE
CAPSULE; ORAL AMBODRYL PARKE DAVIS

25MG

N007984

001

BROMODIPHENHYDRAMINE HYDROCHLORIDE; CODEINE PHOSPHATE

SYRUP; ORAL AMBENYL FOREST LABS 12.5MG/5ML;10MG/5ML BROMANYL ALPHARMA US PHARMS 12.5MG/5ML;10MG/5ML BROMODIPHENHYDRAMINE HYDROCHLORIDE AND CODEINE PHOSPHATE WOCKHARDT 12.5MG/5ML;10MG/5ML

N009319 A088343 A088626

006 001 001

Jan 10, 1984 Aug 15, 1984 Oct 12, 1984

BROMPHENIRAMINE MALEATE
ELIXIR; ORAL BROMPHENIRAMINE MALEATE ALPHARMA US PHARMS KV PHARM PHARM ASSOC USL PHARMA INJECTABLE; INJECTION BROMPHENIRAMINE MALEATE WATSON LABS DIMETANE-TEN WYETH AYERST TABLET; ORAL BROMPHENIRAMINE MALEATE BARR IVAX SUB TEVA PHARMS NEWTRON PHARMS NEXGEN PHARMA INC PAR PHARM PIONEER PHARMS SANDOZ

2MG/5ML 2MG/5ML 2MG/5ML 2MG/5ML

A086936 A085466 A087517 A087964

001 001 001 001

Jan 25, 1983

10MG/ML 100MG/ML 10MG/ML

A083821 A083820 N011418

001 001 002

4MG 4MG 4MG 4MG 4MG 4MG 4MG

A084468 A084351 A086987 A086187 A087009 A088604 A083215

001 001 001 001 001 001 001

Jul 13, 1984

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DISCONTINUED DRUG PRODUCT LIST

BROMPHENIRAMINE MALEATE
TABLET; ORAL BROMPHENIRAMINE MALEATE VITARINE 4MG WATSON LABS 4MG 4MG DIMETANE WYETH CONS 4MG TABLET, EXTENDED RELEASE; ORAL DIMETANE WYETH CONS 8MG 12MG

6 - 48 (of 346)

A085850 A083123 A085769 N010799

001 001 001 003

N010799 N010799

010 011

Jun 10, 1983 Jun 10, 1983

BROMPHENIRAMINE MALEATE; CODEINE PHOSPHATE; PHENYLPROPANOLAMINE HYDROCHLORIDE

SYRUP; ORAL BROMANATE DC ALPHARMA US PHARMS DIMETANE-DC ROBINS AH MYPHETANE DC WOCKHARDT

2MG/5ML;10MG/5ML;12.5MG/5ML 2MG/5ML;10MG/5ML;12.5MG/5ML 2MG/5ML;10MG/5ML;12.5MG/5ML

A088723 N011694 A088904

001 006 001

Feb 25, 1985 Mar 29, 1984 Feb 21, 1985

BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

SYRUP; ORAL BROMANATE DM ALPHARMA US PHARMS BROMFED-DM WOCKHARDT DIMETANE-DX ROBINS AH

2MG/5ML;10MG/5ML;30MG/5ML 2MG/5ML;10MG/5ML;30MG/5ML 2MG/5ML;10MG/5ML;30MG/5ML

A088722 A089681 N019279

001 001 001

Mar 07, 1985 Dec 22, 1988 Aug 24, 1984

BROMPHENIRAMINE MALEATE; PHENYLPROPANOLAMINE HYDROCHLORIDE

ELIXIR; ORAL BIPHETAP MORTON GROVE BROMANATE ALPHARMA US PHARMS DIMETAPP WYETH CONS TABLET, EXTENDED RELEASE; BROMATAPP COPLEY PHARM DIMETAPP WYETH CONS

4MG/5ML;25MG/5ML 4MG/5ML;25MG/5ML 2MG/5ML;12.5MG/5ML ORAL 12MG;75MG 12MG;75MG

A088687 A088688 N013087

001 001 003

Sep 26, 1984 Feb 06, 1985 Mar 29, 1984

A071099 N012436

001 003

Jul 02, 1987 May 14, 1985

BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE

TABLET, EXTENDED RELEASE; ORAL EFIDAC 24 PSEUDOEPHEDRINE HYDROCHLORIDE/BROMPHENIRAMINE MALEATE ALZA 16MG;240MG

N019672

001

Mar 29, 1996

BUCLIZINE HYDROCHLORIDE
TABLET; ORAL BUCLADIN-S STUART PHARMS

50MG

N010911

006

BUDESONIDE
AEROSOL, METERED; NASAL

RHINOCORT

ASTRAZENECA 0.032MG/INH POWDER, METERED; INHALATION PULMICORT ASTRAZENECA 0.32MG/INH

N020233

001

Feb 14, 1994

N020441

003

Jun 24, 1997

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

BUDESONIDE
SPRAY, METERED; NASAL RHINOCORT ASTRAZENECA

6 - 49 (of 346)

0.064MG/INH

N020746

002

Oct 01, 1999

BUMETANIDE
INJECTABLE; INJECTION BUMETANIDE HOSPIRA TEVA PARENTERAL BUMEX VALIDUS PHARMS INC TABLET; ORAL BUMEX VALIDUS PHARMS INC

0.25MG/ML 0.25MG/ML 0.25MG/ML

A074160 A074613 N018226

001 001 001

Oct 30, 1997 Nov 18, 1997 Feb 28, 1983

0.5MG 1MG 2MG

N018225 N018225 N018225

002 001 003

Feb 28, 1983 Feb 28, 1983 Jun 14, 1985

BUPIVACAINE HYDROCHLORIDE

INJECTABLE; INJECTION

BUPIVACAINE HYDROCHLORIDE KIT
HOSPIRA 0.075% 0.114% 0.23%

N019978 N019978 N019978

001 002 003

Sep 03, 1992 Sep 03, 1992 Sep 03, 1992

BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE

INJECTABLE; INJECTION

BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
HOSPIRA 0.25%;0.005MG/ML 0.5%;0.005MG/ML 0.75%;0.005MG/ML

A071166 A071169 A071171

001 001 001

Jun 16, 1988 Jun 16, 1988 Jun 16, 1988

BUPIVACAINE HYDROCHLORIDE; LIDOCAINE HYDROCHLORIDE

INJECTABLE; INJECTION DUOCAINE AMPHASTAR PHARMS INC

EQ 0.375% (37.5MG/10ML);EQ 1% (100MG/10ML)

N021496

001

May 23, 2003

BUPROPION HYDROCHLORIDE
TABLET; ORAL BUPROPION HYDROCHLORIDE SANDOZ 75MG 100MG WELLBUTRIN GLAXOSMITHKLINE 50MG TABLET, EXTENDED RELEASE; ORAL BUPROPION HYDROCHLORIDE SANDOZ 100MG 150MG 150MG WELLBUTRIN SR GLAXOSMITHKLINE 50MG ZYBAN GLAXOSMITHKLINE 100MG

A075613 A075613 N018644

002 001 001

Oct 10, 2000 Oct 10, 2000 Dec 30, 1985

A076845 A076834 A076845 N020358 N020711

001 001 002 001 002

Jul 14, 2005 Jul 14, 2005 Jul 14, 2005 Oct 04, 1996 May 14, 1997

BUSPIRONE HYDROCHLORIDE

CAPSULE; ORAL

BUSPAR
BRISTOL MYERS SQUIBB 5MG 7.5MG 10MG 15MG

N021190 N021190 N021190 N021190

001 002 003 004

Dec Dec Dec Dec

20, 20, 20, 20,

2000 2000 2000 2000

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

BUSPIRONE HYDROCHLORIDE
TABLET; ORAL BUSPAR BRISTOL MYERS SQUIBB

6 - 50 (of 346)

5MG 10MG 15MG 30MG

N018731 N018731 N018731 N018731 A075388 A075388 A075388 A078302 A075385 A075385 A075385 A075413 A075413 A075413

001 002 003 004 001 002 003 001 001 002 003 001 002 003

Sep Sep Apr Apr May May May Dec Mar Mar Mar Mar Mar Mar

29, 29, 22, 22, 09, 09, 09, 17, 01, 01, 01, 19, 19, 19,

1986 1986 1996 1996 2002 2002 2002 2007 2002 2002 2002 2002 2002 2002

BUSPIRONE HYDROCHLORIDE ACTAVIS TOTOWA 5MG 10MG 15MG 30MG IVAX SUB TEVA PHARMS 5MG 10MG 15MG SANDOZ 5MG 10MG 15MG

BUTABARBITAL SODIUM
CAPSULE; ORAL BUTICAPS MEDPOINTE PHARM HLC

15MG 30MG 50MG 100MG

A085381 A085381 A085381 A085381

001 002 003 004

ELIXIR; ORAL BUTABARB ALPHARMA US PHARMS BUTABARBITAL SODIUM WOCKHARDT BUTALAN LANNETT SARISOL HALSEY TABLET; ORAL BUTABARBITAL BUNDY BUTABARBITAL SODIUM SANDOZ

30MG/5ML 30MG/5ML 33.3MG/5ML 30MG/5ML

A085873 A085383 A085880 A084723

001 001 001 001

30MG 15MG 15MG 30MG 30MG 16.2MG 32.4MG 48.6MG 97.2MG 15MG 30MG 15MG 30MG 15MG 30MG 15MG 100MG 15MG 30MG 15MG 30MG

A085550 A084292 A085938 A084272 A085934 A083606 A083898 A083897 A083896 A088632 A088631 A085764 A085772 A083325 A083337 N000793 N000793 A084719 A084719 A083484 A084040

001 003 001 002 001 001 001 001 001 001 001 001 001 002 001 002 005 001 002 001 001 Feb 09, 1982

SOLVAY

TEVA WATSON LABS WHITEWORTH TOWN PLSN BUTISOL SODIUM MEDA PHARMS SARISOL NO. 1 HALSEY SARISOL NO. 2 HALSEY SODIUM BUTABARBITAL IVAX SUB TEVA PHARMS

May 18, 1985 May 01, 1985

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DISCONTINUED DRUG PRODUCT LIST

BUTABARBITAL SODIUM
TABLET; ORAL SODIUM BUTABARBITAL LANNETT

6 - 51 (of 346)

MARSHALL PHARMA WEST WARD

15MG 30MG 100MG 16.2MG 32.4MG 15MG 30MG

A085849 A085866 A085881 A083524 A083858 A085418 A085432

001 001 001 001 001 001 001

BUTOCONAZOLE NITRATE
CREAM; VAGINAL FEMSTAT ROCHE PALO SUPPOSITORY; VAGINAL FEMSTAT ROCHE PALO

2%

N019215

001

Nov 25, 1985

100MG

N019359

001

Nov 25, 1985

BUTORPHANOL TARTRATE
INJECTABLE; INJECTION BUTORPHANOL TARTRATE HOSPIRA

1MG/ML 1MG/ML 2MG/ML 2MG/ML BUTORPHANOL TARTRATE PRESERVATIVE FREE HOSPIRA 1MG/ML 1MG/ML 2MG/ML 2MG/ML SPRAY, METERED; NASAL STADOL BRISTOL MYERS SQUIBB 1MG/SPRAY

A075342 A075559 A075342 A075559 A074620 A075170 A074620 A075170

001 001 002 002 001 001 002 002

Nov Mar Nov Mar Jan Sep Jan Sep

04, 20, 04, 20, 22, 28, 22, 28,

1999 2000 1999 2000 1997 1998 1997 1998

N019890

001

Dec 12, 1991

CABERGOLINE
TABLET; ORAL DOSTINEX PHARMACIA AND UPJOHN

0.5MG

N020664

001

Dec 23, 1996

CAFFEINE; ERGOTAMINE TARTRATE

SUPPOSITORY; RECTAL CAFERGOT NOVARTIS TABLET; ORAL CAFERGOT NOVARTIS WIGRAINE ORGANON USA INC

100MG;2MG

N009000

002

100MG;1MG 100MG;1MG

N006620 A086562

001 001

CALCIFEDIOL
CAPSULE; ORAL CALDEROL ORGANON USA INC

0.02MG 0.05MG

N018312 N018312

001 002

CALCIPOTRIENE
OINTMENT; TOPICAL DOVONEX LEO PHARM

0.005%

N020273

001

Dec 29, 1993

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DISCONTINUED DRUG PRODUCT LIST

CALCITONIN HUMAN
INJECTABLE; INJECTION CIBACALCIN NOVARTIS

6 - 52 (of 346)

0.5MG/VIAL

N018470

001

Oct 31, 1986

CALCITONIN SALMON
INJECTABLE; INJECTION CALCIMAR SANOFI AVENTIS US CALCITONIN-SALMON ASTRAZENECA MIACALCIN NOVARTIS

200 IU/ML 400 IU/VIAL 200 IU/ML 100 IU/ML

N017769 N017497 A073690 N017808

001 001 001 001 Apr 14, 1995 Jul 03, 1986

CALCITRIOL
INJECTABLE; INJECTION

CALCITRIOL

HOSPIRA TEVA PARENTERAL

0.001MG/ML 0.002MG/ML 0.001MG/ML

A075816 A075816 A075823

001 002 001

Jan 16, 2004 Jan 16, 2004 Mar 31, 2003

CALCIUM ACETATE
CAPSULE; ORAL PHOSLO FRESENIUS MEDCL TABLET; ORAL CALCIUM ACETATE ROXANE PHOSLO FRESENIUS MEDCL

EQ 84.5MG CALCIUM EQ 169MG CALCIUM

N021160 N021160

001 002

Apr 02, 2001 Apr 02, 2001

EQ 169MG CALCIUM EQ 169MG CALCIUM

A077693 N019976

001 001

Jan 30, 2008 Dec 10, 1990

CALCIUM CARBONATE; RISEDRONATE SODIUM

TABLET, TABLET; ORAL ACTONEL WITH CALCIUM (COPACKAGED) WARNER CHILCOTT EQ 500MG BASE,N/A;N/A,35MG

N021823

001

Aug 12, 2005

CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
INJECTABLE; INJECTION PRISMASOL B22GK 2/2.5 IN PLASTIC CONTAINER GAMBRO RENAL PRODS 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML; 3.05GM/1000ML;0.157GM/1000ML;2.21GM/100 0ML;7.07GM/1000ML PRISMASOL BGK 4/0 IN PLASTIC CONTAINER GAMBRO RENAL PRODS N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.0 5GM/1000ML;0.314GM/1000ML;3.09GM/1000ML ;6.46GM/1000ML PRISMASOL BGK 4/3.5 IN PLASTIC CONTAINER GAMBRO RENAL PRODS 5.15GM/1000ML;20GM/1000ML;5.4GM/1000ML; 2.03GM/1000ML;0.314GM/1000ML;3.09GM/100 0ML;6.46GM/1000ML PRISMASOL BK 0/0 IN PLASTIC CONTAINER GAMBRO RENAL PRODS N/A/1000ML;N/A/1000ML;5.4GM/1000ML;3.05 GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46 GM/1000ML PRISMASOL BK 4/2.5 IN PLASTIC CONTAINER GAMBRO RENAL PRODS 3.68GM/1000ML;N/A/1000ML;5.4GM/1000ML;3 .05GM/1000ML;0.314GM/1000ML;3.09GM/1000 ML;6.46GM/1000ML

N021703

012

Oct 10, 2008

N021703

005

Oct 25, 2006

N021703

008

Oct 25, 2006

N021703

007

Oct 25, 2006

N021703

009

Oct 25, 2006

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DISCONTINUED DRUG PRODUCT LIST

6 - 53 (of 346)

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE
INJECTABLE; INJECTION ISOLYTE R W/ DEXTROSE 5% IN PLASTIC CONTAINER B BRAUN 37MG/100ML;5GM/100ML;31MG/100ML;120MG/1 N018271 00ML;330MG/100ML;88MG/100ML

001

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE
INJECTABLE; INJECTION ISOLYTE E W/ DEXTROSE 5% IN PLASTIC CONTAINER B BRAUN 35MG/100ML;5GM/100ML;30MG/100ML;74MG/10 N018269 0ML;640MG/100ML;500MG/100ML;74MG/100ML

002

Jan 17, 1983

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE

SOLUTION; INTRAPERITONEAL DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER B BRAUN 29MG/100ML;2.5GM/100ML;15MG/100ML;610MG N018460 /100ML;560MG/100ML DIALYTE W/ DEXTROSE 1.5% IN PLASTIC CONTAINER B BRAUN 29MG/100ML;1.5GM/100ML;15MG/100ML;610MG N018460 /100ML;560MG/100ML DIALYTE W/ DEXTROSE 4.25% IN PLASTIC CONTAINER B BRAUN 29MG/100ML;4.25GM/100ML;15MG/100ML;610M N018460 G/100ML;560MG/100ML

006

Jan 29, 1986

001

003

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE

SOLUTION; INTRAPERITONEAL DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER B BRAUN 26MG/100ML;1.5GM/100ML;15MG/100ML;560MG N018460 /100ML;390MG/100ML DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER B BRAUN 26MG/100ML;5GM/100ML;5MG/100ML;530MG/10 N018460 0ML;450MG/100ML DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER B BRAUN 26MG/100ML;4.25GM/100ML;15MG/100ML;560M N018460 G/100ML;390MG/100ML

002

008

Jan 29, 1986

004

CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

INJECTABLE; INJECTION
DEXTROSE 5% IN RINGER'S IN PLASTIC CONTAINER
B BRAUN 33MG/100ML;5GM/100ML;30MG/100ML;860MG/1 N018256 00ML

001

CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE

INJECTABLE; INJECTION DEXTROSE 4% IN MODIFIED LACTATED RINGER'S IN PLASTIC CONTAINER B BRAUN 4MG/100ML;4GM/100ML;6MG/100ML;120MG/100 ML;62MG/100ML DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER B BRAUN 20MG/100ML;5GM/100ML;30MG/100ML;600MG/1 00ML;310MG/100ML MILES 20MG/100ML;5GM/100ML;30MG/100ML;600MG/1 00ML;310MG/100ML POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN HOSPIRA 20MG/100ML;5GM/100ML;104MG/100ML;600MG/ 100ML;310MG/100ML 20MG/100ML;5GM/100ML;179MG/100ML;600MG/ 100ML;310MG/100ML POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN HOSPIRA 20MG/100ML;5GM/100ML;254MG/100ML;600MG/ 100ML;310MG/100ML POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN HOSPIRA 20MG/100ML;5GM/100ML;254MG/100ML;600MG/ 100ML;310MG/100ML

N019634

002

Feb 24, 1988

N017510 N018499

001 001

PLASTIC CONTAINER N019685 005 Oct 17, 1988 N019685 006 Oct 17, 1988

PLASTIC CONTAINER N019685 007 Oct 17, 1988 PLASTIC CONTAINER N019685 003 Oct 17, 1988

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 54 (of 346)

CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE

INJECTABLE; INJECTION POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER HOSPIRA 20MG/100ML;5GM/100ML;104MG/100ML;600MG/ N019685 001 Oct 17, 1988 100ML;310MG/100ML

CALCIUM CHLORIDE; DEXTROSE; SODIUM CHLORIDE; SODIUM LACTATE

SOLUTION; INTRAPERITONEAL INPERSOL-ZM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER FRESENIUS MEDCL 25.7MG/100ML;1.5GM/100ML;538MG/100ML;44 N019395 8MG/100ML INPERSOL-ZM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER FRESENIUS MEDCL 25.7MG/100ML;2.5GM/100ML;538MG/100ML;44 N019395 8MG/100ML INPERSOL-ZM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER FRESENIUS MEDCL 25.7MG/100ML;4.25GM/100ML;538MG/100ML;4 N019395 48MG/100ML

001

Mar 26, 1986

002

Mar 26, 1986

003

Mar 26, 1986

CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE
INJECTABLE; INJECTION TPN ELECTROLYTES IN PLASTIC CONTAINER ABBOTT 16.5MG/ML;25.4MG/ML;74.6MG/ML;121MG/ML; N019399 16.1MG/ML

001

Jun 16, 1986

CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE
INJECTABLE; INJECTION ISOLYTE E IN PLASTIC CONTAINER B BRAUN 35MG/100ML;30MG/100ML;74MG/100ML;640MG/ N018899 100ML;500MG/100ML;74MG/100ML

001

Oct 31, 1983

CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE

INJECTABLE; INJECTION ACETATED RINGER'S IN PLASTIC CONTAINER B BRAUN 20MG/100ML;30MG/100ML;380MG/100ML;600MG N018725 /100ML

001

Nov 29, 1982

CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

INJECTABLE; INJECTION RINGER'S IN PLASTIC CONTAINER B BRAUN 33MG/100ML;30MG/100ML;860MG/100ML SOLUTION; IRRIGATION RINGER'S IN PLASTIC CONTAINER ABBOTT 33MG/100ML;30MG/100ML;860MG/100ML

N018721

001

Nov 09, 1982

N018462

001

CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE

INJECTABLE; INJECTION
LACTATED RINGER'S IN PLASTIC CONTAINER
20MG/100ML;30MG/100ML;600MG/100ML;310MG N019485 ABBOTT /100ML 20MG/100ML;30MG/100ML;600MG/100ML;310MG N018023 B BRAUN /100ML 20MG/100ML;30MG/100ML;600MG/100ML;310MG N018417 MILES /100ML

001 001 001

Oct 24, 1985

CALCIUM GLUCEPTATE
INJECTABLE; INJECTION CALCIUM GLUCEPTATE ABBOTT ABRAXIS PHARM LILLY

EQ EQ EQ EQ

90MG 90MG 90MG 90MG

CALCIUM/5ML CALCIUM/5ML CALCIUM/5ML CALCIUM/5ML

A080001 A083159 A089373 N006470

001 001 001 001

Apr 30, 1987

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 55 (of 346)

CALCIUM METRIZOATE; MEGLUMINE METRIZOATE; METRIZOATE MAGNESIUM; METRIZOATE SODIUM

INJECTABLE; INJECTION

ISOPAQUE 440

GE HEALTHCARE

0.78MG/ML;75.9MG/ML;0.15MG/ML;16.6MG/ML N016847

001

CALCIUM; MEGLUMINE; METRIZOIC ACID

INJECTABLE; INJECTION ISOPAQUE 280 GE HEALTHCARE

0.35MG/ML;140.1MG/ML;461.8MG/ML

N017506

001

CANDICIDIN
OINTMENT; VAGINAL VANOBID SANOFI AVENTIS US TABLET; VAGINAL VANOBID SANOFI AVENTIS US

0.6MG/GM

A061596

001

3MG

A061613

001

CAPTOPRIL
TABLET; ORAL CAPOTEN PAR PHARM

37.5MG 75MG 150MG 12.5MG 25MG 50MG 100MG 12.5MG 25MG 50MG 100MG 12.5MG 25MG 50MG 100MG 12.5MG 25MG 50MG 100MG 12.5MG 25MG 50MG 100MG 12.5MG 25MG 50MG 100MG 12.5MG 25MG 50MG 100MG 12.5MG 12.5MG 25MG 25MG 50MG 50MG 100MG 100MG 12.5MG 25MG

N018343 N018343 N018343 A074472 A074472 A074472 A074472 A074423 A074423 A074423 A074423 A074748 A074748 A074748 A074748 A074418 A074418 A074418 A074418 A074590 A074590 A074590 A074590 A074493 A074493 A074493 A074493 A074640 A074640 A074640 A074640 A074481 A074519 A074481 A074519 A074481 A074519 A074481 A074519 A074433 A074433

006 007 004 001 002 003 004 001 002 003 004 004 002 001 003 001 002 003 004 004 002 001 003 001 002 003 004 001 002 003 004 001 001 002 002 003 003 004 004 001 002

Sep 17, 1986 Jun 13, 1995 Jun 13, 1995 Mar Mar Mar Mar Feb Feb Feb Feb May May May May Feb Feb Feb Feb Aug Aug Aug Aug Feb Feb Feb Feb Mar Mar Mar Mar Feb Feb Feb Feb Feb Feb Feb Feb Feb Feb 31, 31, 31, 31, 13, 13, 13, 13, 29, 29, 29, 29, 13, 13, 13, 13, 30, 30, 30, 30, 13, 13, 13, 13, 31, 31, 31, 31, 13, 13, 13, 13, 13, 13, 13, 13, 13, 13, 1995 1995 1995 1995 1996 1996 1996 1996 1997 1997 1997 1997 1996 1996 1996 1996 1996 1996 1996 1996 1996 1996 1996 1996 1997 1997 1997 1997 1996 1996 1996 1996 1996 1996 1996 1996 1996 1996

CAPTOPRIL APOTHECON

CLONMEL HLTHCARE

EGIS PHARMS

ENDO LABS

IVAX SUB TEVA PHARMS

PAR PHARM

PUREPAC PHARM

SANDOZ

TEVA

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

CAPTOPRIL
TABLET; ORAL CAPTOPRIL TEVA TEVA PHARMS

6 - 56 (of 346)

WATSON LABS

50MG 100MG 12.5MG 25MG 50MG 100MG 12.5MG 25MG 50MG 100MG

A074433 A074433 A074462 A074462 A074462 A074462 A074576 A074576 A074576 A074576

003 004 001 002 003 004 001 002 003 004

Feb Feb Feb Feb Feb Feb Apr Apr Apr Apr

13, 13, 13, 13, 13, 13, 23, 23, 23, 23,

1996 1996 1996 1996 1996 1996 1996 1996 1996 1996

CAPTOPRIL; HYDROCHLOROTHIAZIDE
TABLET; ORAL CAPTOPRIL AND HYDROCHLOROTHIAZIDE ENDO LABS 25MG;15MG 25MG;25MG 50MG;15MG 50MG;25MG IVAX SUB TEVA PHARMS 25MG;15MG 25MG;25MG 50MG;15MG 50MG;25MG WATSON LABS 50MG;25MG

A074788 A074788 A074788 A074788 A075055 A075055 A075055 A075055 A074832

001 002 004 003 001 002 004 003 001

Dec Dec Dec Dec Jun Jun Jun Jun Dec

29, 29, 29, 29, 18, 18, 18, 18, 29,

1997 1997 1997 1997 1998 1998 1998 1998 1997

CARBACHOL
SOLUTION; INTRAOCULAR CARBACHOL PHARMAFAIR CARBASTAT NOVARTIS

0.01% 0.01%

A070292 A073677

001 001

May 21, 1986 Apr 28, 1995

CARBAMAZEPINE
SUSPENSION; ORAL CARBAMAZEPINE TARO TABLET; ORAL CARBAMAZEPINE ACTAVIS ELIZABETH INWOOD LABS PLIVA USL PHARMA WARNER CHILCOTT TERIL TARO TABLET, CHEWABLE; ORAL CARBAMAZEPINE JUBILANT CADISTA

100MG/5ML

A075875

001

Dec 21, 2000

200MG 200MG 200MG 200MG 200MG 200MG

A071696 A070231 A071479 A070300 A070429 A076525

001 001 001 001 001 001

Nov Aug Jul May Jan

09, 14, 24, 15, 02,

1987 1986 1987 1986 1987

Sep 26, 2003

100MG

A071940

001

Feb 01, 1988

CARBENICILLIN DISODIUM
INJECTABLE; INJECTION GEOPEN ROERIG

EQ EQ EQ EQ EQ

1GM BASE/VIAL 2GM BASE/VIAL 5GM BASE/VIAL 10GM BASE/VIAL 30GM BASE/VIAL

N050306 N050306 N050306 N050306 N050306 N050298 N050298 N050298

001 004 002 006 007 001 002 003

PYOPEN GLAXOSMITHKLINE

EQ 1GM BASE/VIAL EQ 2GM BASE/VIAL EQ 5GM BASE/VIAL

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

CARBENICILLIN DISODIUM
INJECTABLE; INJECTION PYOPEN GLAXOSMITHKLINE

6 - 57 (of 346)

EQ 10GM BASE/VIAL EQ 20GM BASE/VIAL

N050298 N050298

006 007

CARBENICILLIN INDANYL SODIUM

TABLET; ORAL GEOCILLIN PFIZER

EQ 382MG BASE

N050435

001

CARBIDOPA; LEVODOPA
TABLET; ORAL CARBIDOPA AND LEVODOPA SANDOZ

10MG;100MG 25MG;100MG 25MG;250MG SCS 10MG;100MG 25MG;100MG 25MG;250MG WATSON LABS 10MG;100MG 25MG;100MG 25MG;250MG TABLET, EXTENDED RELEASE; ORAL CARBIDOPA AND LEVODOPA KV PHARM 50MG;200MG TABLET, FOR SUSPENSION; ORAL CARBILEV RANBAXY 10MG;100MG 25MG;100MG 25MG;250MG

A073586 A073587 A073620 A074080 A074080 A074080 A073381 A073382 A073383

001 001 001 001 002 003 001 001 001

Jun Jun Jun Mar Mar Mar Sep Sep Sep

29, 29, 29, 25, 25, 25, 28, 28, 28,

1995 1995 1995 1994 1994 1994 1993 1993 1993

A076663

001

Jun 24, 2004

A076643 A076643 A076643

001 002 003

Jun 10, 2005 Jun 10, 2005 Jun 10, 2005

CARBINOXAMINE MALEATE
ELIXIR; ORAL CLISTIN MCNEIL TABLET; ORAL CLISTIN ORTHO MCNEIL PHARM

4MG/5ML

N008955

001

4MG

N008915

001

CARBOPLATIN
INJECTABLE; INJECTION CARBOPLATIN HOSPIRA

50MG/VIAL 150MG/VIAL 450MG/VIAL 50MG/VIAL 150MG/VIAL 450MG/VIAL

A076473 A076473 A076473 N019880 N019880 N019880

001 002 003 001 002 003

Oct 27, 2004 Oct 27, 2004 Oct 27, 2004 Mar 03, 1989 Mar 03, 1989 Mar 03, 1989

PARAPLATIN BRISTOL MYERS SQUIBB

INJECTABLE; IV (INFUSION) CARBOPLATIN APP PHARMS 50MG/5ML (10MG/ML) 150MG/15ML (10MG/ML) SAGENT PHARMS 50MG/5ML (10MG/ML) 150MG/15ML (10MG/ML) 450MG/45ML (10MG/ML) TEVA PARENTERAL 50MG/5ML (10MG/ML) 150MG/15ML (10MG/ML) 450MG/45ML (10MG/ML) PARAPLATIN BRISTOL MYERS SQUIBB 50MG/5ML (10MG/ML) 150MG/15ML (10MG/ML) 450MG/45ML (10MG/ML)

A077247 A077247 A077096 A077096 A077096 A077389 A077389 A077389 N020452 N020452 N020452

001 002 001 002 003 001 002 003 001 002 003

Oct Oct Jun Jun Jun Mar Mar Mar

21, 21, 14, 14, 14, 30, 30, 30,

2004 2004 2005 2005 2005 2007 2007 2007

Jul 14, 2003 Jul 14, 2003 Jul 14, 2003

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

CARBOPLATIN
INJECTABLE; IV (INFUSION) PARAPLATIN BRISTOL MYERS SQUIBB 600MG/60ML (10MG/ML)

6 - 58 (of 346)

N020452

004

Jan 15, 2004

CARISOPRODOL
CAPSULE; ORAL SOMA MEDA PHARMS TABLET; ORAL CARISOPRODOL ABLE PIONEER PHARMS SANDOZ WATSON LABS

250MG

N011792

003

350MG 350MG 350MG 350MG 350MG 350MG 350MG 350MG

A040421 A089390 A081025 A089566 A040152 A085433 A086179 N012155

001 001 001 001 001 001 001 001

Jun Oct Apr Aug Dec

21, 13, 13, 30, 03,

2001 1988 1989 1988 1996

RELA SCHERING

CARPHENAZINE MALEATE
CONCENTRATE; ORAL PROKETAZINE WYETH AYERST TABLET; ORAL PROKETAZINE WYETH AYERST

50MG/ML

N014173

001

12.5MG 25MG 50MG

N012768 N012768 N012768

001 002 004

CARPROFEN
TABLET; ORAL RIMADYL ROCHE

100MG 150MG

N018550 N018550

002 003

Dec 31, 1987 Dec 31, 1987

CARTEOLOL HYDROCHLORIDE
TABLET; ORAL CARTROL ABBOTT

2.5MG 5MG 10MG

N019204 N019204 N019204

001 002 003

Dec 28, 1988 Dec 28, 1988 Dec 28, 1988

CEFACLOR
CAPSULE; ORAL CECLOR LILLY CEFACLOR CEPH INTL CLONMEL HLTHCARE IVAX SUB TEVA PHARMS MARSAM PHARMS LLC TEVA

EQ 250MG BASE EQ 500MG BASE EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ 250MG 500MG 250MG 500MG 250MG 500MG 250MG 500MG 250MG 250MG 500MG 500MG BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE

N050521 N050521 A062205 A062205 A064107 A064107 A064061 A064061 A064148 A064148 A064081 A064145 A064081 A064145

001 002 001 002 001 002 001 002 001 002 001 001 002 002

Apr Apr Apr Apr May May Sep Jun Sep Jun

27, 27, 27, 27, 23, 23, 16, 24, 16, 24,

1995 1995 1995 1995 1996 1996 1996 1996 1996 1996

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

CEFACLOR
FOR SUSPENSION; ORAL CECLOR LILLY CEFACLOR CLONMEL HLTHCARE

6 - 59 (of 346)

EQ 125MG BASE/5ML EQ 250MG BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML

N050522 N050522 A064114 A064115 A064116 A064110 A062206 A062206 A062206 A062206 A064087 A064086 A064085 A064070 A064204 A064205 A064206 A064207

001 002 001 001 001 001 001 003 002 004 001 001 001 001 001 001 001 001 Apr Apr Apr Apr 28, 28, 28, 28, 1995 1995 1995 1995

EQ 125MG EQ 187MG EQ 250MG EQ 375MG FACTA FARMA EQ 125MG EQ 187MG EQ 250MG EQ 375MG IVAX SUB TEVA PHARMS EQ 125MG EQ 187MG EQ 250MG EQ 375MG MARSAM PHARMS LLC EQ 125MG EQ 187MG EQ 250MG EQ 375MG TABLET, EXTENDED RELEASE; ORAL CECLOR CD LILLY EQ 375MG EQ 500MG CEFACLOR WORLD GEN EQ 500MG

Apr 20, 1988 Apr Apr Apr Apr Apr Feb Feb Feb Feb 20, 28, 28, 28, 28, 18, 18, 18, 18, 1988 1995 1995 1995 1995 1998 1998 1998 1998

BASE BASE BASE

N050673 N050673 A065057

001 002 001

Jun 28, 1996 Jun 28, 1996 Jan 05, 2001

CEFADROXIL/CEFADROXIL HEMIHYDRATE
CAPSULE; ORAL CEFADROXIL IVAX SUB TEVA PHARMS PUREPAC PHARM TEVA DURICEF WARNER CHILCOTT ULTRACEF BRISTOL FOR SUSPENSION; ORAL CEFADROXIL APOTHECON

EQ 500MG BASE EQ 500MG BASE EQ 500MG BASE EQ 250MG BASE EQ 500MG BASE EQ 500MG BASE

A062766 A063017 A062695 N050512 N050512 A062378

001 001 001 002 001 001

Mar 03, 1987 Jan 05, 1989 Feb 10, 1989

Mar 16, 1982

TEVA

EQ EQ EQ EQ EQ EQ

125MG 250MG 500MG 125MG 250MG 500MG

BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML

A062334 A062334 A062334 A062698 A062698 A062698 N050527 N050527 N050527 A062376 A062376 A062376

001 002 003 001 002 003 002 003 001 001 002 003

Mar 01, 1989 Mar 01, 1989 Mar 01, 1989

DURICEF WARNER CHILCOTT

EQ 125MG BASE/5ML EQ 250MG BASE/5ML EQ 500MG BASE/5ML EQ 125MG BASE/5ML EQ 250MG BASE/5ML EQ 500MG BASE/5ML

ULTRACEF BRISTOL

Mar 16, 1982 Mar 16, 1982 Mar 16, 1982

TABLET; ORAL DURICEF WARNER CHILCOTT ULTRACEF APOTHECON BRISTOL

EQ 1GM BASE EQ 1GM BASE EQ 1GM BASE

N050528 A062390 A062408

001 001 001 Jun 10, 1982 Aug 31, 1982

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DISCONTINUED DRUG PRODUCT LIST

CEFAMANDOLE NAFATE
INJECTABLE; INJECTION MANDOL LILLY

6 - 60 (of 346)

EQ EQ EQ EQ EQ EQ

500MG BASE/VIAL 1GM BASE/VIAL 1GM BASE/VIAL 2GM BASE/VIAL 2GM BASE/VIAL 10GM BASE/VIAL

N050504 A062560 N050504 A062560 N050504 N050504

001 001 002 002 003 004

Sep 10, 1985 Sep 10, 1985

CEFAZOLIN SODIUM
INJECTABLE; INJECTION ANCEF GLAXOSMITHKLINE

EQ 250MG BASE/VIAL EQ 500MG BASE/VIAL EQ 1GM BASE/VIAL EQ 5GM BASE/VIAL EQ 10GM BASE/VIAL ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER BAXTER HLTHCARE EQ 10MG BASE/ML EQ 20MG BASE/ML ANCEF IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER BAXTER HLTHCARE EQ 10MG BASE/ML EQ 20MG BASE/ML CEFAZOLIN AND DEXTROSE B BRAUN EQ 500MG BASE/VIAL CEFAZOLIN SODIUM ABRAXIS PHARM EQ 500MG BASE/VIAL EQ 1GM BASE/VIAL EQ 10GM BASE/VIAL EQ 20GM BASE/VIAL BEDFORD EQ 250MG BASE/VIAL EQ 500MG BASE/VIAL EQ 1GM BASE/VIAL EQ 5GM BASE/VIAL EQ 10GM BASE/VIAL ELKINS SINN EQ 250MG BASE/VIAL EQ 500MG BASE/VIAL EQ 1GM BASE/VIAL EQ 5GM BASE/VIAL EQ 10GM BASE/VIAL EQ 20GM BASE/VIAL GLAXOSMITHKLINE EQ 1GM BASE/VIAL MARSAM PHARMS LLC EQ 250MG BASE/VIAL EQ 500MG BASE/VIAL EQ 1GM BASE/VIAL EQ 5GM BASE/VIAL EQ 10GM BASE/VIAL EQ 20GM BASE/VIAL TEVA EQ 250MG BASE/VIAL EQ 500MG BASE/VIAL EQ 1GM BASE/VIAL EQ 5GM BASE/VIAL EQ 10GM BASE/VIAL KEFZOL ACS DOBFAR EQ 250MG BASE/VIAL EQ 20GM BASE/VIAL LILLY EQ 500MG BASE/VIAL EQ 1GM BASE/VIAL

N050461 N050461 N050461 N050461 N050461 N050566 N050566 N050566 N050566 N050779 A062688 A062688 A062688 A062688 A062894 A062894 A062894 A062894 A062894 A062807 A062807 A062807 A062807 A062807 A062807 A064033 A062988 A062988 A062988 A062989 A062989 A062989 A063016 A063016 A063016 A063018 A063018 A061773 A061773 A062557 A062557

001 002 003 004 005 003 004 001 002 001 002 003 004 005 001 002 003 004 005 001 002 003 004 005 006 001 001 002 003 001 002 003 001 002 003 001 002 001 005 001 002 Jun 08, 1983 Jun 08, 1983 Jun 08, 1983 Jun 08, 1983 Jul 27, 2000 Nov Nov Nov Aug Jul Jul Jul Jul Jul Jan Jan Jan Jan Jan Jan Oct Dec Dec Dec Dec Dec Dec Mar Mar Mar Mar Mar 17, 17, 17, 03, 21, 21, 21, 21, 21, 12, 12, 12, 12, 12, 12, 31, 29, 29, 29, 29, 29, 29, 14, 14, 14, 05, 05, 1986 1986 1986 1987 1988 1988 1988 1988 1988 1988 1988 1988 1988 1988 1988 1993 1989 1989 1989 1989 1989 1989 1989 1989 1989 1990 1990

Sep 08, 1987 Sep 10, 1985 Sep 10, 1985

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

CEFDINIR
CAPSULE; ORAL OMNICEF ABBOTT FOR SUSPENSION; ORAL OMNICEF ABBOTT

6 - 61 (of 346)

300MG

N050739

001

Dec 04, 1997

125MG/5ML 250MG/5ML

N050749 N050749

001 002

Dec 04, 1997 Jul 29, 2004

CEFIXIME
FOR SUSPENSION; ORAL SUPRAX LEDERLE TABLET; ORAL SUPRAX LEDERLE

100MG/5ML

N050622

001

Apr 28, 1989

200MG 400MG

N050621 N050621

001 002

Apr 28, 1989 Apr 28, 1989

CEFMENOXIME HYDROCHLORIDE
INJECTABLE; INJECTION CEFMAX TAP PHARM

EQ 500MG BASE/VIAL EQ 1GM BASE/VIAL EQ 2GM BASE/VIAL

N050571 N050571 N050571

001 002 003

Dec 30, 1987 Dec 30, 1987 Dec 30, 1987

CEFMETAZOLE SODIUM
INJECTABLE; INJECTION ZEFAZONE PHARMACIA AND UPJOHN

EQ 1GM BASE/VIAL EQ 2GM BASE/VIAL ZEFAZONE IN PLASTIC CONTAINER PHARMACIA AND UPJOHN EQ 20MG BASE/ML EQ 40MG BASE/ML

N050637 N050637 N050683 N050683

001 002 001 002

Dec 11, 1989 Dec 11, 1989 Dec 29, 1992 Dec 29, 1992

CEFONICID SODIUM
INJECTABLE; INJECTION MONOCID GLAXOSMITHKLINE

EQ EQ EQ EQ EQ

500MG BASE/VIAL 1GM BASE/VIAL 1GM BASE/VIAL 2GM BASE/VIAL 10GM BASE/VIAL

N050579 A063295 N050579 N050579 N050579

001 001 002 003 004

May Jul May May May

23, 26, 23, 23, 23,

1984 1993 1984 1984 1984

CEFOPERAZONE SODIUM
INJECTABLE; INJECTION CEFOBID PFIZER

EQ 1GM BASE/VIAL EQ 1GM BASE/VIAL EQ 2GM BASE/VIAL EQ 2GM BASE/VIAL EQ 10GM BASE/VIAL CEFOBID IN PLASTIC CONTAINER PFIZER EQ 20MG BASE/ML EQ 40MG BASE/ML

A063333 N050551 A063333 N050551 N050551 N050613 N050613

001 001 002 002 003 002 001

Mar Nov Mar Nov Mar

31, 18, 31, 18, 05,

1995 1982 1995 1982 1990

Jul 31, 1987 Jul 23, 1986

CEFORANIDE
INJECTABLE; INJECTION PRECEF APOTHECON

500MG/VIAL 1GM/VIAL 2GM/VIAL 10GM/VIAL 20GM/VIAL

A062579 A062579 A062579 A062579 A062579

001 002 003 004 005

Nov Nov Nov Nov Nov

26, 26, 26, 26, 26,

1984 1984 1984 1984 1984

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

CEFORANIDE
INJECTABLE; INJECTION PRECEF BRISTOL

6 - 62 (of 346)

500MG/VIAL 1GM/VIAL 2GM/VIAL 10GM/VIAL 20GM/VIAL

N050554 N050554 N050554 N050554 N050554

001 002 003 004 005

May May May May May

24, 24, 24, 24, 24,

1984 1984 1984 1984 1984

CEFOTAXIME SODIUM
INJECTABLE; INJECTION CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER B BRAUN EQ 2GM BASE CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINER B BRAUN EQ 1GM BASE CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SANOFI AVENTIS US EQ 20MG BASE/ML EQ 40MG BASE/ML

N050792 N050792 N050596 N050596

001 002 001 003

Jul 29, 2004 Jul 29, 2004 May 20, 1985 May 20, 1985

CEFOTETAN DISODIUM
INJECTABLE; INJECTION CEFOTAN ASTRAZENECA

EQ 1GM BASE/VIAL EQ 1GM BASE/VIAL EQ 2GM BASE/VIAL EQ 2GM BASE/VIAL EQ 10GM BASE/VIAL CEFOTAN IN PLASTIC CONTAINER ASTRAZENECA EQ 20MG BASE/ML EQ 40MG BASE/ML

A063293 N050588 A063293 N050588 N050588 N050694 N050694

001 001 002 002 003 002 001

Apr Dec Apr Dec Apr

29, 27, 29, 27, 25,

1993 1985 1993 1985 1988

Jul 30, 1993 Jul 30, 1993

CEFOTIAM HYDROCHLORIDE
INJECTABLE; INJECTION CERADON TAKEDA

EQ 1GM BASE/VIAL

N050601

001

Dec 30, 1988

CEFOXITIN SODIUM
INJECTABLE; INJECTION MEFOXIN BIONICHE PHARMA MYLAN

MEFOXIN MERCK MEFOXIN MERCK

EQ 1GM BASE/VIAL EQ 2GM BASE/VIAL INSTITUTIONAL EQ 1GM BASE/VIAL EQ 2GM BASE/VIAL EQ 10GM BASE/VIAL IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 20MG BASE/ML EQ 40MG BASE/ML IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER EQ 20MG BASE/ML EQ 40MG BASE/ML

A062757 A062757 N050517 N050517 N050517 N050581 N050581 N050581 N050581

001 002 001 002 003 003 004 002 001

Jan 08, 1987 Jan 08, 1987

Sep 20, 1984 Sep 20, 1984 Sep 20, 1984 Sep 20, 1984

CEFPIRAMIDE SODIUM
INJECTABLE; INJECTION CEFPIRAMIDE SODIUM WYETH AYERST

EQ 1GM BASE/VIAL EQ 2GM BASE/VIAL EQ 10GM BASE/VIAL

N050633 N050633 N050633

002 003 005

Jan 31, 1989 Jan 31, 1989 Jan 31, 1989

CEFPODOXIME PROXETIL
FOR SUSPENSION; ORAL BANAN SANKYO

EQ 50MG BASE/5ML EQ 100MG BASE/5ML

N050688 N050688

002 001

Aug 07, 1992 Aug 07, 1992

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

CEFPODOXIME PROXETIL
FOR SUSPENSION; ORAL VANTIN PHARMACIA AND UPJOHN TABLET; ORAL BANAN SANKYO VANTIN PHARMACIA AND UPJOHN

6 - 63 (of 346)

EQ 50MG BASE/5ML EQ 100MG BASE/5ML

N050675 N050675

001 002

Aug 07, 1992 Aug 07, 1992

EQ 100MG BASE EQ 200MG BASE EQ 100MG BASE EQ 200MG BASE

N050687 N050687 N050674 N050674

001 002 001 002

Aug 07, 1992 Aug 07, 1992 Aug 07, 1992 Aug 07, 1992

CEFPROZIL
FOR SUSPENSION; ORAL CEFZIL BRISTOL MYERS SQUIBB TABLET; ORAL CEFZIL BRISTOL MYERS SQUIBB

125MG/5ML 250MG/5ML

N050665 N050665

001 002

Dec 23, 1991 Dec 23, 1991

250MG 500MG

N050664 N050664

001 002

Dec 23, 1991 Dec 23, 1991

CEFTAZIDIME
INJECTABLE; INJECTION CEPTAZ GLAXOSMITHKLINE

500MG/VIAL 1GM/VIAL 2GM/VIAL 10GM/VIAL 1GM/VIAL 1GM/VIAL 2GM/VIAL 2GM/VIAL 6GM/VIAL 10GM/VIAL

N050646 N050646 N050646 N050646 A063322 A064006 A063322 A064006 A064008 A064008 A062655 A062655 A062739 A062739

001 002 003 004 001 001 002 002 001 002 001 002 001 002

Sep Sep Sep Sep Nov Mar Nov Mar Mar Mar

27, 27, 27, 27, 07, 31, 07, 31, 31, 31,

1990 1990 1990 1990 1995 1992 1995 1992 1992 1992

PENTACEF GLAXOSMITHKLINE

1GM/VIAL 2GM/VIAL TAZIDIME IN PLASTIC CONTAINER LILLY 1GM/VIAL 2GM/VIAL

TAZIDIME LILLY

Nov 20, 1985 Nov 20, 1985 Jul 10, 1986 Jul 10, 1986

CEFTAZIDIME SODIUM
INJECTABLE; INJECTION CEFTAZIDIME SODIUM IN PLASTIC CONTAINER BAXTER HLTHCARE EQ 10MG BASE/ML EQ 20MG BASE/ML EQ 40MG BASE/ML FORTAZ IN PLASTIC CONTAINER GLAXOSMITHKLINE EQ 10MG BASE/ML

A063221 A063221 A063221 N050634

001 002 003 001

Apr 29, 1993 Apr 29, 1993 Apr 29, 1993 Apr 28, 1989

CEFTIBUTEN DIHYDRATE
FOR SUSPENSION; ORAL CEDAX PERNIX THERAP

EQ 180MG BASE/5ML

N050686

002

Dec 20, 1995

CEFTIZOXIME SODIUM
INJECTABLE; INJECTION CEFIZOX ASTELLAS

EQ 500MG BASE/VIAL EQ 1GM BASE/VIAL

N050560 A063294

001 002

Sep 15, 1983 Mar 31, 1994

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

CEFTIZOXIME SODIUM
INJECTABLE; INJECTION CEFIZOX ASTELLAS

6 - 64 (of 346)

CEFIZOX IN ASTELLAS CEFIZOX IN ASTELLAS

EQ 1GM BASE/VIAL EQ 2GM BASE/VIAL EQ 2GM BASE/VIAL EQ 10GM BASE/VIAL DEXTROSE 5% IN PLASTIC CONTAINER EQ 20MG BASE/ML EQ 40MG BASE/ML PLASTIC CONTAINER EQ 20MG BASE/ML EQ 40MG BASE/ML

N050560 A063294 N050560 N050560 N050589 N050589 N050589 N050589

002 003 003 005 001 002 003 004

Sep Mar Sep Mar

15, 31, 15, 19,

1983 1994 1983 1993

Oct 03, 1984 Oct 03, 1984 Apr 13, 1995 Apr 13, 1995

CEFTRIAXONE SODIUM
INJECTABLE; ****** ROCEPHIN HOFFMANN LA ROCHE

EQ 500MG BASE/VIAL EQ 1GM BASE/VIAL EQ 2GM BASE/VIAL

N050585 N050585 N050585

002 003 004

Dec 21, 1984 Dec 21, 1984 Dec 21, 1984

INJECTABLE; IM-IV ROCEPHIN HOFFMANN LA ROCHE INJECTABLE; INJECTION ROCEPHIN HOFFMANN LA ROCHE

EQ 250MG BASE/VIAL

N050585

001

Dec 21, 1984

EQ 250MG BASE/VIAL EQ 500MG BASE/VIAL EQ 1GM BASE/VIAL EQ 2GM BASE/VIAL EQ 10GM BASE/VIAL ROCHE EQ 250MG BASE/VIAL EQ 500MG BASE/VIAL EQ 1GM BASE/VIAL ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER HOFFMANN LA ROCHE EQ 10MG BASE/ML EQ 20MG BASE/ML EQ 40MG BASE/ML

A063239 A062654 A062654 A062654 N050585 A062510 A062510 A062510 N050624 N050624 N050624

001 001 002 003 005 001 002 003 001 002 003

Aug Apr Apr Apr Dec Mar Mar Mar

13, 30, 30, 30, 21, 12, 12, 12,

1993 1987 1987 1987 1984 1985 1985 1985

Feb 11, 1987 Feb 11, 1987 Feb 11, 1987

CEFTRIAXONE SODIUM; LIDOCAINE

INJECTABLE; INJECTION ROCEPHIN KIT HOFFMANN LA ROCHE

EQ 500MG BASE/VIAL,N/A;N/A,1% EQ 1GM BASE/VIAL,N/A;N/A,1%

N050585 N050585

007 006

May 08, 1996 May 08, 1996

CEFUROXIME AXETIL
TABLET; ORAL CEFUROXIME AXETIL SANDOZ

EQ 250MG BASE EQ 500MG BASE

A065126 A065126

001 002

Oct 28, 2003 Oct 28, 2003

CEFUROXIME SODIUM
INJECTABLE; IM-IV CEFUROXIME SODIUM MARSAM PHARMS LLC KEFUROX ACS DOBFAR INJECTABLE; INJECTION CEFUROXIME SODIUM MARSAM PHARMS LLC KEFUROX ACS DOBFAR

EQ 750MG BASE/VIAL EQ 750MG BASE/VIAL

A064035 A062591

001 001

Feb 26, 1993 Jan 10, 1986

EQ 1.5GM BASE/VIAL EQ 7.5GM BASE/VIAL EQ 1.5GM BASE/VIAL EQ 7.5GM BASE/VIAL

A064035 A064036 A062591 A062591

002 001 002 003

Feb 26, 1993 Feb 26, 1993 Jan 10, 1986 Dec 17, 1987

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

CEFUROXIME SODIUM
INJECTABLE; INJECTION KEFUROX LILLY EQ 1.5GM KEFUROX IN PLASTIC CONTAINER LILLY EQ 1.5GM INJECTABLE; INTRAVENOUS KEFUROX LILLY EQ 750MG KEFUROX IN PLASTIC CONTAINER LILLY EQ 750MG

6 - 65 (of 346)

BASE/VIAL BASE/VIAL

A062592 A062590

002 002

Jan 10, 1986 Jan 10, 1986

BASE/VIAL BASE/VIAL

A062592 A062590

001 001

Jan 10, 1986 Jan 10, 1986

CELLULOSE SODIUM PHOSPHATE

POWDER; ORAL CALCIBIND MISSION PHARMA

2.5GM/PACKET 300GM/BOT

N018757 N018757

002 003

Dec 28, 1982 Oct 16, 1984

CEPHALEXIN
CAPSULE; ORAL CEPHALEXIN APOTHECON

BARR IVAX SUB TEVA PHARMS PUREPAC PHARM STEVENS J TEVA

YOSHITOMI KEFLEX SHIONOGI INC FOR SUSPENSION; ORAL CEPHALEXIN APOTHECON BARR FACTA FARMA TEVA

EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ

250MG 250MG 250MG 500MG 500MG 500MG 250MG 500MG 250MG 500MG 250MG 500MG 500MG 250MG 250MG 500MG 500MG 250MG 500MG

BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE

A062973 A063063 A063186 A062974 A063063 A063186 A062773 A062775 A061969 A061969 A062809 A062809 A062869 A062760 A062821 A062761 A062823 A062872 A062871 N050405

001 001 001 001 002 002 001 001 001 002 001 002 001 001 001 001 001 001 001 004

Nov Sep Dec Nov Sep Dec Jun Apr

08, 29, 30, 23, 29, 30, 26, 22,

1988 1989 1994 1988 1989 1994 1987 1987

Apr Apr Mar Apr Feb Apr Feb Jun Jul

22, 22, 17, 24, 05, 24, 05, 20, 05,

1987 1987 1988 1987 1988 1987 1988 1988 1988

EQ 333MG BASE

May 12, 2006

VITARINE KEFLEX LEX PHARMS

EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ

125MG 250MG 125MG 250MG 100MG 125MG 125MG 250MG 250MG 125MG 250MG

BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML

A062986 A062987 A062778 A062777 A062117 A062767 A062873 A062768 A062867 A062779 A062781 N050406 N050406 N050406

001 001 001 001 001 001 001 001 001 001 001 003 001 002

Apr Jul Aug Aug Jun May Jun Apr Dec Dec

18, 25, 06, 06, 16, 23, 16, 15, 22, 22,

1991 1989 1987 1987 1987 1988 1987 1988 1987 1987

EQ 100MG BASE/ML EQ 125MG BASE/5ML EQ 250MG BASE/5ML

TABLET; ORAL CEPHALEXIN BARR VITARINE

EQ 250MG BASE EQ 500MG BASE EQ 250MG BASE

A062826 A062827 A062863

001 001 001

Aug 17, 1987 Aug 17, 1987 Aug 11, 1988

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

CEPHALEXIN
TABLET; ORAL CEPHALEXIN VITARINE KEFLET LILLY

6 - 66 (of 346)

EQ 500MG BASE EQ 1GM BASE 250MG BASE 250MG BASE 500MG BASE 500MG BASE 1GM BASE

A062863 A062863 A062745 N050440 A062745 N050440 N050440

002 003 001 003 002 001 002

Aug 11, 1988 Aug 11, 1988 Dec 01, 1986 Feb 26, 1987 Dec 01, 1986

EQ EQ EQ EQ EQ TABLET, FOR SUSPENSION; ORAL PANIXINE DISPERDOSE RANBAXY LABS LTD EQ EQ

125MG BASE 250MG BASE

A065100 A065100

002 001

Sep 11, 2003 Sep 11, 2003

CEPHALEXIN HYDROCHLORIDE
TABLET; ORAL KEFTAB LILLY

EQ 250MG BASE EQ 333MG BASE EQ 500MG BASE

N050614 N050614 N050614

001 003 002

Oct 29, 1987 May 16, 1988 Oct 29, 1987

CEPHALOGLYCIN
CAPSULE; ORAL KAFOCIN LILLY

250MG

N050219

001

CEPHALOTHIN SODIUM
INJECTABLE; INJECTION CEPHALOTHIN INTL MEDICATION

EQ EQ EQ EQ

500MG BASE/VIAL 1GM BASE/VIAL 2GM BASE/VIAL 4GM BASE/VIAL

A062426 A062426 A062426 A062426 A062547 A062548 A062547 A062548 A062666 A062666 A062464 A062464 A062464 A062422 A062422 A062730 A062422 A062422 A062730 A062422 A062422 N050482 N050482 N050482 N050482 A062549 A062549

001 002 003 004 001 001 002 002 002 001 001 002 003 003 005 001 004 006 002 001 002 001 002 003 007 001 002

May May May May Sep Sep Sep Sep Jun Jun May May May Jan Jul Mar Jan Jul Mar

03, 03, 03, 03, 11, 11, 11, 11, 10, 10, 07, 07, 07, 31, 16, 05, 31, 16, 05,

1985 1985 1985 1985 1985 1985 1985 1985 1987 1987 1984 1984 1984 1984 1991 1987 1984 1991 1987

CEPHALOTHIN SODIUM ABBOTT

EQ 1GM BASE/VIAL EQ 1GM BASE/VIAL EQ 2GM BASE/VIAL EQ 2GM BASE/VIAL ABRAXIS PHARM EQ 1GM BASE/VIAL EQ 2GM BASE/VIAL BRISTOL EQ 1GM BASE/VIAL EQ 2GM BASE/VIAL EQ 4GM BASE/VIAL CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER BAXTER HLTHCARE EQ 20MG BASE/ML EQ 20MG BASE/ML EQ 20MG BASE/ML EQ 40MG BASE/ML EQ 40MG BASE/ML EQ 40MG BASE/ML CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER BAXTER HLTHCARE EQ 20MG BASE/ML EQ 40MG BASE/ML KEFLIN LILLY EQ 1GM BASE/VIAL EQ 2GM BASE/VIAL EQ 4GM BASE/VIAL EQ 20GM BASE/VIAL KEFLIN IN PLASTIC CONTAINER LILLY EQ 1GM BASE/VIAL EQ 2GM BASE/VIAL

Jan 31, 1984 Jan 31, 1984

Sep 10, 1985 Sep 10, 1985

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

CEPHALOTHIN SODIUM
INJECTABLE; INJECTION SEFFIN GLAXOSMITHKLINE

6 - 67 (of 346)

EQ 1GM BASE/VIAL EQ 2GM BASE/VIAL EQ 10GM BASE/VIAL

A062435 A062435 A062435

001 002 003

Nov 15, 1983 Nov 15, 1983 Nov 15, 1983

CEPHAPIRIN SODIUM
INJECTABLE; INJECTION CEFADYL APOTHECON

EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ

500MG BASE/VIAL 500MG BASE/VIAL 1GM BASE/VIAL 1GM BASE/VIAL 1GM BASE/VIAL 1GM BASE/VIAL 2GM BASE/VIAL 2GM BASE/VIAL 2GM BASE/VIAL 2GM BASE/VIAL 4GM BASE/VIAL 4GM BASE/VIAL 4GM BASE/VIAL 20GM BASE/VIAL 500MG BASE/VIAL 1GM BASE/VIAL 2GM BASE/VIAL 4GM BASE/VIAL 20GM BASE/VIAL 500MG BASE/VIAL 1GM BASE/VIAL 2GM BASE/VIAL 20GM BASE/VIAL

A062961 N050446 A061769 A062724 A062961 N050446 A061769 A062724 A062961 N050446 A061769 A062961 N050446 N050446 A062723 A062723 A062723 A062723 A062723 A062720 A062720 A062720 A062720

001 005 001 001 002 001 002 002 003 002 003 004 003 004 001 002 003 004 005 001 002 003 004

Sep 20, 1988

Dec 23, 1986 Sep 20, 1988

Dec 23, 1986 Sep 20, 1988

Sep 20, 1988

CEPHAPIRIN SODIUM ABRAXIS PHARM

BAXTER HLTHCARE

Nov Nov Nov Nov Nov Jul Jul Jul Jul

17, 17, 17, 17, 17, 02, 02, 02, 02,

1986 1986 1986 1986 1986 1987 1987 1987 1987

CEPHRADINE
CAPSULE; ORAL ANSPOR GLAXOSMITHKLINE CEPHRADINE BARR IVAX SUB TEVA PHARMS TEVA VITARINE VELOSEF APOTHECON VELOSEF '250' ERSANA VELOSEF '500' ERSANA FOR SUSPENSION; ORAL ANSPOR GLAXOSMITHKLINE CEPHRADINE BARR

250MG 500MG 250MG 500MG 250MG 500MG 250MG 500MG 250MG 500MG 250MG 500MG 250MG 500MG

A061859 A061859 A062850 A062851 A062762 A062762 A062683 A062683 A062813 A062813 A061764 A061764 N050548 N050548

001 002 001 001 001 002 001 002 001 002 001 002 001 002 Apr Apr Mar Mar Jan Jan Feb Feb 22, 22, 06, 06, 09, 09, 25, 25, 1988 1988 1987 1987 1987 1987 1988 1988

125MG/5ML 250MG/5ML 125MG/5ML 250MG/5ML

A061866 A061866 A062858 A062859

001 002 001 001 May 19, 1988 May 19, 1988

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

CEPHRADINE
FOR SUSPENSION; ORAL CEPHRADINE TEVA VELOSEF '125' APOTHECON VELOSEF '250' APOTHECON INJECTABLE; INJECTION VELOSEF APOTHECON

6 - 68 (of 346)

125MG/5ML 250MG/5ML 125MG/5ML 250MG/5ML

A062693 A062693 A061763 A061763

001 002 001 002

Jan 09, 1987 Jan 09, 1987

250MG/VIAL 500MG/VIAL 1GM/VIAL 2GM/VIAL 4GM/VIAL

A061976 A061976 A061976 A061976 A061976

001 002 004 003 005

TABLET; ORAL VELOSEF BRISTOL MYERS SQUIBB

1GM

N050530

001

CERIVASTATIN SODIUM
TABLET; ORAL BAYCOL BAYER PHARMS

0.05MG 0.1MG 0.2MG 0.3MG 0.4MG 0.8MG

N020740 N020740 N020740 N020740 N020740 N020740

001 002 003 004 005 006

Jun Jun Jun Jun May Jul

26, 26, 26, 26, 24, 24,

1997 1997 1997 1997 1999 2000

CERULETIDE DIETHYLAMINE
INJECTABLE; INJECTION TYMTRAN PHARMACIA AND UPJOHN

0.02MG/ML

N018296

001

CETIRIZINE HYDROCHLORIDE
SYRUP; ORAL CETIRIZINE HYDROCHLORIDE ACTAVIS MID ATLANTIC 5MG/5ML CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY ACTAVIS MID ATLANTIC 5MG/5ML CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF ACTAVIS MID ATLANTIC 5MG/5ML

A078617 A090378 A090378

001 002 001

Feb 02, 2010 May 09, 2008 May 09, 2008

CETYL ALCOHOL; COLFOSCERIL PALMITATE; TYLOXAPOL

FOR SUSPENSION; INTRATRACHEAL EXOSURF NEONATAL GLAXOSMITHKLINE 12MG/VIAL;108MG/VIAL;8MG/VIAL

N020044

001

Aug 02, 1990

CHENODIOL
TABLET; ORAL CHENIX SIGMA TAU

250MG

N018513

002

Jul 28, 1983

CHLOPHEDIANOL HYDROCHLORIDE
SYRUP; ORAL ULO 3M

25MG/5ML

N012126

001

CHLORAMPHENICOL
CAPSULE; ORAL AMPHICOL FERRANTE

100MG

A060058

001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

CHLORAMPHENICOL
CAPSULE; ORAL AMPHICOL FERRANTE CHLORAMPHENICOL IVAX SUB TEVA PHARMS CHLOROMYCETIN PARKEDALE

6 - 69 (of 346)

250MG 250MG 50MG 100MG 250MG

A060058 A062247 A060591 A060591 A060591 A060851

002 001 001 003 002 001

MYCHEL ARMENPHARM 250MG CREAM; TOPICAL CHLOROMYCETIN PARKE DAVIS 1% FOR SOLUTION; OPHTHALMIC CHLOROMYCETIN PARKEDALE 25MG/VIAL INJECTABLE; INJECTION CHLOROMYCETIN PARKE DAVIS 250MG/ML OINTMENT; OPHTHALMIC CHLORAMPHENICOL ALTANA 1% CHLOROFAIR PHARMAFAIR 1% CHLOROMYCETIN PARKEDALE 1% CHLOROPTIC S.O.P. ALLERGAN 1% ECONOCHLOR ALCON 1% SOLUTION/DROPS; OPHTHALMIC CHLORAMPHENICOL AKORN 0.5% ALCON 0.5% CHLOROFAIR PHARMAFAIR 0.5% CHLOROPTIC ALLERGAN 0.5% ECONOCHLOR ALCON 0.5% OPHTHOCHLOR PARKEDALE 0.5% OPTOMYCIN OPTOPICS 0.5% SOLUTION/DROPS; OTIC CHLOROMYCETIN PARKEDALE 0.5%

N050183

001

N050143

001

N050153

001

A060133 A062439 N050156 A061187 A061648

001 001 001 001 001 Apr 21, 1983

A062042 A062628 A062437 N050091 A061645 A061220 A062171

001 001 001 001 001 001 001

Sep 25, 1985 Apr 14, 1983

Mar 31, 1982

N050205

001

CHLORAMPHENICOL PALMITATE
SUSPENSION; ORAL CHLOROMYCETIN PALMITATE PARKE DAVIS EQ 150MG BASE/5ML EQ 150MG BASE/5ML

A062301 N050152

001 001

CHLORAMPHENICOL SODIUM SUCCINATE

INJECTABLE; INJECTION CHLORAMPHENICOL ELKINS SINN EQ 1GM BASE/VIAL CHLORAMPHENICOL SODIUM SUCCINATE GRUPPO LEPETIT EQ 1GM BASE/VIAL CHLOROMYCETIN PARKEDALE EQ 1GM BASE/VIAL

A062406 A062278 N050155

001 001 001

Nov 09, 1982

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

CHLORAMPHENICOL SODIUM SUCCINATE
INJECTABLE; INJECTION MYCHEL-S ANGUS

6 - 70 (of 346)

EQ 1GM BASE/VIAL

A060132

001

CHLORAMPHENICOL; DESOXYRIBONUCLEASE; FIBRINOLYSIN

OINTMENT; TOPICAL ELASE-CHLOROMYCETIN PARKE DAVIS

10MG/GM;666 UNITS/GM;1 UNITS/GM

N050294

001

CHLORAMPHENICOL; HYDROCORTISONE ACETATE

FOR SUSPENSION; OPHTHALMIC CHLOROMYCETIN HYDROCORTISONE PARKEDALE 12.5MG/VIAL;25MG/VIAL

N050202

001

CHLORAMPHENICOL; HYDROCORTISONE ACETATE; POLYMYXIN B SULFATE

OINTMENT; OPHTHALMIC OPHTHOCORT PARKEDALE

10MG/GM;5MG/GM;10,000 UNITS/GM

N050201

002

CHLORAMPHENICOL; POLYMYXIN B SULFATE

OINTMENT; OPHTHALMIC CHLOROMYXIN PARKE DAVIS

1%;10,000 UNITS/GM

N050203

002

CHLORAMPHENICOL; PREDNISOLONE
OINTMENT; OPHTHALMIC CHLOROPTIC-P S.O.P. ALLERGAN

1%;0.5%

A061188

001

CHLORDIAZEPOXIDE
CAPSULE, EXTENDED RELEASE; ORAL LIBRELEASE VALEANT PHARM INTL 30MG TABLET; ORAL LIBRITABS VALEANT PHARM INTL 5MG 10MG 25MG

N017813

001

Sep 12, 1983

A085482 A085481 A085488

001 001 001

CHLORDIAZEPOXIDE HYDROCHLORIDE
CAPSULE; ORAL A-POXIDE ABBOTT

5MG 5MG 10MG 10MG 25MG 25MG

A085447 A085517 A085447 A085518 A085447 A085513 A085086 A084639 A085087 A087525 A087524 A087512 A085118 A085119 A085120 A085340 A085339 A084685

001 001 002 001 003 001 001 001 001 001 001 001 001 001 001 001 001 001 Jan 07, 1982 Jan 07, 1982 Jan 07, 1982

5MG 10MG 25MG CHLORDIAZEPOXIDE HYDROCHLORIDE ASCOT 5MG 10MG 25MG FERRANTE 5MG 10MG 25MG HALSEY 5MG 10MG 25MG

CHLORDIAZACHEL RACHELLE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

CHLORDIAZEPOXIDE HYDROCHLORIDE
CAPSULE; ORAL CHLORDIAZEPOXIDE HYDROCHLORIDE IMPAX LABS 5MG 10MG 25MG IVAX SUB TEVA PHARMS 5MG 10MG 25MG LEDERLE 5MG 5MG 10MG 10MG 25MG 25MG MAST MM 10MG MYLAN 5MG 10MG 25MG PARKE DAVIS 5MG 10MG 25MG PIONEER PHARMS 10MG 25MG PUREPAC PHARM 5MG 10MG 25MG ROXANE 5MG 10MG 25MG SANDOZ 5MG 5MG 10MG 10MG 25MG 25MG SUPERPHARM 5MG 10MG 25MG TEVA 5MG 10MG 25MG 25MG USL PHARMA 5MG 25MG VANGARD 5MG 10MG 25MG WEST WARD 5MG 10MG 25MG LIBRIUM VALEANT PHARM INTL 5MG 10MG 25MG LYGEN ALRA 5MG 10MG 25MG INJECTABLE; INJECTION LIBRIUM VALEANT PHARM INTL 100MG/AMP

6 - 71 (of 346)

A086213 A085113 A086212 A083741 A083742 A083570 A086892 A087234 A086876 A087037 A086893 A087231 A086217 A084886 A084601 A084887 A085163 A084598 A085164 A089533 A089558 A085155 A084939 A085144 A084706 A084700 A084705 A084678 A084919 A084041 A084920 A084679 A084823 A088987 A088986 A088988 A088705 A088706 A086494 A088707 A084644 A084645 A088129 A088010 A088130 A085014 A085000 A085294 N012249 N012249 N012249 A085107 A085009 A085108

001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 002 001 001 001 001 001 001 001 001 002 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 002 001 003 001 001 001

Jul 15, 1988 Jul 15, 1988

Apr Apr Apr Jan Jan

25, 25, 25, 18, 18,

1985 1985 1985 1985 1985

Jan 18, 1985

Mar 28, 1983 Mar 28, 1983 Mar 28, 1983

N012301

001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

CHLORDIAZEPOXIDE; ESTROGENS, ESTERIFIED
TABLET; ORAL MENRIUM 10-4 ROCHE MENRIUM 5-2 ROCHE MENRIUM 5-4 ROCHE

6 - 72 (of 346)

10MG;0.4MG 5MG;0.2MG 5MG;0.4MG

N014740 N014740 N014740

006 002 004

CHLORHEXIDINE GLUCONATE
SOLUTION; TOPICAL EXIDINE XTTRIUM MICRODERM J AND J PREVACARE R J AND J STERI-STAT MATRIX MEDCL SPONGE; TOPICAL CHLORHEXIDINE GLUCONATE KENDALL IL E-Z SCRUB BECTON DICKINSON HIBICLENS MOLNLYCKE HLTH MICRODERM J AND J

2.5% 4% 0.5% 4%

N019421 A072255 A072292 A070104

001 001 001 001

Dec 17, 1985 Apr 15, 1991 Jan 28, 1992 Jul 24, 1986

4% 4% 4% 4%

N019490 A073416 N018423 A072295

001 001 001 001

Mar 27, 1987 Mar 14, 2000

Feb 28, 1991

CHLORMERODRIN HG-197
INJECTABLE; INJECTION CHLORMERODRIN HG 197 BRACCO

0.6-1.4mCi/ML

N017269

001

CHLORMEZANONE
TABLET; ORAL TRANCOPAL SANOFI AVENTIS US

100MG 200MG

N011467 N011467

003 005

CHLOROPROCAINE HYDROCHLORIDE
INJECTABLE; INJECTION NESACAINE-MPF APP PHARMS

2% 3%

N009435 N009435

003 004

CHLOROQUINE HYDROCHLORIDE
INJECTABLE; INJECTION ARALEN HYDROCHLORIDE SANOFI AVENTIS US

EQ 40MG BASE/ML

N006002

002

CHLOROQUINE PHOSPHATE
TABLET; ORAL CHLOROQUINE PHOSPHATE MD PHARM PUREPAC PHARM TEVA WATSON LABS

EQ EQ EQ EQ EQ

150MG 150MG 150MG 150MG 300MG

BASE BASE BASE BASE BASE

A087228 A080886 A087504 A087979 A088030

001 001 001 001 001

Jan 13, 1982 Dec 21, 1982 Dec 21, 1982

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

CHLOROQUINE PHOSPHATE; PRIMAQUINE PHOSPHATE
TABLET; ORAL ARALEN PHOSPHATE W/ PRIMAQUINE PHOSPHATE SANOFI AVENTIS US EQ 300MG BASE;EQ 45MG BASE

6 - 73 (of 346)

N014860

002

CHLOROTHIAZIDE
TABLET; ORAL CHLOROTHIAZIDE ABC HOLDING LEDERLE SANDOZ WATSON LABS

250MG 250MG 500MG 250MG 250MG 250MG 250MG 500MG 500MG 250MG 500MG

A085569 A086940 A086938 A085485 A085165 A085173 A086795 A084026 A086796 N011145 N011145

001 001 001 001 001 001 001 001 001 004 002

Aug 15, 1983 Sep 01, 1982 Aug 15, 1983

DIURIL LUNDBECK INC

CHLOROTHIAZIDE; METHYLDOPA
TABLET; ORAL ALDOCLOR-150 MERCK 150MG;250MG ALDOCLOR-250 MERCK 250MG;250MG METHYLDOPA AND CHLOROTHIAZIDE PAR PHARM 150MG;250MG 250MG;250MG

N016016 N016016 A070783 A070654

001 002 001 001 Nov 06, 1987 Nov 06, 1987

CHLOROTHIAZIDE; RESERPINE
TABLET; ORAL CHLOROTHIAZIDE AND RESERPINE WEST WARD 250MG;0.125MG 500MG;0.125MG CHLOROTHIAZIDE W/ RESERPINE WATSON LABS 250MG;0.125MG 500MG;0.125MG CHLOROTHIAZIDE-RESERPINE MYLAN 250MG;0.125MG 500MG;0.125MG DIUPRES-250 MERCK 250MG;0.125MG DIUPRES-500 MERCK 500MG;0.125MG

A088557 A088365 A084853 A088151 A087744 A087745 N011635 N011635

001 001 001 001 001 001 003 006

Dec 22, 1983 Dec 22, 1983

Jun 09, 1983 May 06, 1982 May 06, 1982 Aug 26, 1987 Aug 26, 1987

CHLOROTRIANISENE
CAPSULE; ORAL CHLOROTRIANISENE BANNER PHARMACAPS TACE SANOFI AVENTIS US

12MG 12MG 25MG 72MG

A084652 N008102 N011444 N016235

001 004 001 001

CHLOROXINE
SHAMPOO; TOPICAL CAPITROL WESTWOOD SQUIBB

2%

N017594

001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

CHLORPHENESIN CARBAMATE
TABLET; ORAL MAOLATE PHARMACIA AND UPJOHN

6 - 74 (of 346)

400MG

N014217

002

CHLORPHENIRAMINE MALEATE
CAPSULE, EXTENDED RELEASE; ORAL CHLORPHENIRAMINE MALEATE SANDOZ 12MG TELDRIN GLAXOSMITHKLINE 8MG 12MG INJECTABLE; INJECTION CHLORPHENIRAMINE MALEATE BEL MAR 10MG/ML ELKINS SINN 10MG/ML WATSON LABS 10MG/ML 10MG/ML 100MG/ML CHLOR-TRIMETON SCHERING PLOUGH 10MG/ML 100MG/ML PYRIDAMAL 100 BEL MAR 100MG/ML SYRUP; ORAL CHLORPHENIRAMINE MALEATE PHARM ASSOC 2MG/5ML CHLOR-TRIMETON SCHERING 2MG/5ML TABLET; ORAL ANTAGONATE BAYER PHARMS 4MG CHLORPHENIRAMINE MALEATE ANABOLIC 4MG BELL PHARMA 4MG ELKINS SINN 4MG IMPAX LABS 4MG IVAX SUB TEVA PHARMS 4MG KV PHARM 4MG LEDERLE 4MG MUTUAL PHARM 4MG NEWTRON PHARMS 4MG PANRAY 4MG PHARMAVITE 4MG PHARMERAL 4MG PIONEER PHARMS 4MG PUREPAC PHARM 4MG PVT FORM 4MG ROXANE 4MG SANDOZ 4MG VITARINE 4MG WATSON LABS 4MG 4MG 4MG WEST WARD 4MG CHLOR-TRIMETON SCHERING 4MG KLOROMIN HALSEY 4MG PHENETRON LANNETT 4MG TABLET, EXTENDED RELEASE; ORAL CHLOR-TRIMETON SCHERING PLOUGH 8MG

A070797 N017369 N017369

001 001 002

Aug 12, 1988

A080821 A080797 A083593 A086096 A086095 N008826 N008794 A083733

001 001 001 001 001 001 001 001

A087520 N006921

001 006

Feb 10, 1982

A083381 A083078 A083062 A080938 A080809 A080779 A087164 A086941 A080700 A086519 A083243 A085104 A083753 A088556 A086306 A080786 A080626 A080961 A085837 A080696 A080791 A085139 A083787 N006921 A083629 A080846

001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 002 001 001

Jul 13, 1984

N007638

001

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DISCONTINUED DRUG PRODUCT LIST

CHLORPHENIRAMINE MALEATE
TABLET, EXTENDED RELEASE; ORAL EFIDAC 24 CHLORPHENIRAMINE MALEATE ALZA 16MG

6 - 75 (of 346)

N019746

002

Nov 18, 1994

CHLORPHENIRAMINE MALEATE; PHENYLPROPANOLAMINE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE; ORAL CHLOROHENIRAMINE MALEATE AND PHENYLPROPANOLAMINE HYDROCHLORIDE WATSON LABS 12MG;75MG CHLORPHENIRAMINE MALEATE AND PHENYLPROPANOLAMINE HYDROCHLORIDE SANDOZ 12MG;75MG COLD CAPSULE IV GRAHAM DM 12MG;75MG COLD CAPSULE V GRAHAM DM 8MG;75MG CONTAC 12 HOUR GLAXOSMITHKLINE 8MG;75MG DRIZE ASCHER 12MG;75MG ORNADE GLAXOSMITHKLINE 12MG;75MG PHENYLPROPANOLAMINE HYDROCHLORIDE W/ CHLORPHENIRAMINE MALEATE CENT PHARMS 8MG;75MG TABLET, EXTENDED RELEASE; ORAL CONTAC NOVARTIS 12MG;75MG DEMAZIN SCHERING PLOUGH 4MG;25MG TRIAMINIC-12 NOVARTIS 12MG;75MG

A088681 A088940 N018793 N018794 N018099 A088359 N012152 N018809

001 001 001 001 001 001 004 001

Sep 29, 1987 Jan 26, 1989 Apr 25, 1985 Apr 23, 1985

Feb 13, 1986

May 07, 1984

N019613 N018556 N018115

001 001 001

Jun 13, 1986 May 14, 1984

CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE; ORAL CODIMAL-L.A. 12 SCHWARZ PHARMA 12MG;120MG ISOCLOR FISONS 8MG;120MG PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE CENT PHARMS 8MG;120MG GRAHAM DM 8MG;120MG 12MG;120MG KV PHARM 12MG;120MG

N018935 N018747 N019428 N018844 N018843 A071455

001 001 001 001 001 001

Apr 15, 1985 Mar 06, 1986 Aug Mar Mar Mar 02, 20, 18, 01, 1988 1985 1985 1989

CHLORPHENIRAMINE POLISTIREX; CODEINE POLISTIREX

SUSPENSION, EXTENDED RELEASE; ORAL CODEPREX UCB INC EQ 4MG MALEATE/5ML;EQ 20MG BASE/5ML PENNTUSS FISONS EQ 4MG MALEATE/5ML;EQ 10MG BASE/5ML

N021369 N018928

001 001

Jun 21, 2004 Aug 14, 1985

CHLORPHENIRAMINE POLISTIREX; PHENYLPROPANOLAMINE POLISTIREX

SUSPENSION, EXTENDED RELEASE; ORAL CORSYM UCB INC EQ 4MG MALEATE/5ML;EQ 37.5MG HCL/5ML

N018050

001

Jan 04, 1984

CHLORPHENTERMINE HYDROCHLORIDE
TABLET; ORAL PRE-SATE PARKE DAVIS

EQ 65MG BASE

N014696

001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

CHLORPROMAZINE
SUPPOSITORY; RECTAL THORAZINE GLAXOSMITHKLINE

6 - 76 (of 346)

25MG 100MG

N009149 N009149

024 033

CHLORPROMAZINE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL THORAZINE GLAXOSMITHKLINE 30MG 75MG 150MG 200MG 300MG CONCENTRATE; ORAL CHLORPROMAZINE HYDROCHLORIDE ACTAVIS MID ATLANTIC 100MG/ML PHARM ASSOC 30MG/ML 100MG/ML WOCKHARDT 30MG/ML 100MG/ML CHLORPROMAZINE HYDROCHLORIDE INTENSOL ROXANE 30MG/ML 100MG/ML SONAZINE SANDOZ 30MG/ML 100MG/ML THORAZINE GLAXOSMITHKLINE 30MG/ML 100MG/ML INJECTABLE; INJECTION CHLORPROMAZINE HYDROCHLORIDE ABRAXIS PHARM 25MG/ML MARSAM PHARMS LLC 25MG/ML WATSON LABS 25MG/ML 25MG/ML WYETH AYERST 25MG/ML THORAZINE GLAXOSMITHKLINE 25MG/ML SYRUP; ORAL CHLORPROMAZINE HYDROCHLORIDE ALPHARMA US PHARMS 10MG/5ML SONAZINE SANDOZ 10MG/5ML THORAZINE GLAXOSMITHKLINE 10MG/5ML TABLET; ORAL CHLORPROMAZINE HYDROCHLORIDE ABBOTT 10MG 25MG 50MG 100MG 200MG IVAX SUB TEVA PHARMS 10MG 25MG 50MG 100MG 200MG KV PHARM 10MG 25MG 50MG 100MG 200MG LEDERLE 10MG

N011120 N011120 N011120 N011120 N011120

016 017 018 019 020

A086863 A040231 A040224 A087032 A087053 A088157 A088158 A080983 A080983 N009149 N009149

001 001 001 001 001 001 001 004 005 032 043

Dec 30, 1999 Jan 26, 1999 Jul 08, 1982

Apr 27, 1983 Apr 27, 1983

A084911 A089563 A080365 A085591 A080370 N009149

001 001 001 001 001 011

Apr 15, 1988

A086712 A083040 N009149

001 001 022

A084414 A084415 A084411 A084412 A084413 A083549 A083549 A083549 A083574 A083575 A085750 A085751 A085484 A085752 A085748 A084803

001 001 001 001 001 001 002 003 001 001 002 001 001 001 002 001

Jan 04, 1982

Jan 04, 1982

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

CHLORPROMAZINE HYDROCHLORIDE
TABLET; ORAL CHLORPROMAZINE HYDROCHLORIDE LEDERLE 25MG 50MG 100MG 200MG PUREPAC PHARM 10MG 25MG 50MG 100MG 200MG PVT FORM 25MG 50MG 200MG ROXANE 10MG 25MG 50MG 100MG 200MG VANGARD 10MG 25MG 50MG WATSON LABS 10MG 25MG 50MG 100MG 200MG WEST WARD 10MG 25MG 50MG 100MG 200MG PROMAPAR PARKE DAVIS 10MG 25MG 50MG 100MG 200MG THORAZINE GLAXOSMITHKLINE 10MG 25MG 50MG 100MG 200MG

6 - 77 (of 346)

A084801 A084800 A084789 A084802 A080403 A080403 A080403 A080403 A080403 A080340 A080340 A080340 A085331 A085331 A085331 A085331 A085331 A088038 A087645 A087646 A085959 A085956 A085960 A085957 A085958 A087783 A087865 A087878 A087884 A087880 A086886 A084423 A086887 A086888 A086885 N009149 N009149 N009149 N009149 N009149

001 001 001 001 004 001 002 003 005 001 002 003 001 002 003 004 005 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 002 007 013 018 020

Aug 16, 1982

Sep Sep Sep Sep Sep

16, 16, 15, 15, 16,

1982 1982 1982 1982 1982

CHLORPROPAMIDE
TABLET; ORAL CHLORPROPAMIDE BARR

CLONMEL HLTHCARE DURAMED PHARMS BARR HALSEY IVAX PHARMS PAR PHARM

100MG 100MG 250MG 250MG 100MG 250MG 100MG 250MG 100MG 250MG 100MG 250MG 100MG 250MG

A088812 A089446 A088813 A089447 A089561 A089562 A088918 A088919 A089321 A088662 A088840 A087353 A088175 A088176

001 001 001 001 001 001 001 001 001 001 001 001 001 001

Oct Nov Oct Nov Sep Sep Oct Oct Jan Jan Oct

19, 17, 19, 17, 04, 04, 16, 16, 16, 09, 25,

1984 1986 1984 1986 1987 1987 1984 1984 1986 1986 1984

Feb 27, 1984 Feb 27, 1984

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

CHLORPROPAMIDE
TABLET; ORAL CHLORPROPAMIDE SANDOZ

6 - 78 (of 346)

SUPERPHARM TEVA USL PHARMA WATSON LABS

100MG 250MG 250MG 100MG 250MG 100MG 100MG 250MG 100MG 100MG 250MG 250MG 250MG

A088725 A084669 A088726 A088694 A088695 A088768 A088708 A088709 A086865 A088608 A086866 A088568 A088641

001 001 001 001 001 001 001 001 001 001 001 001 001

Aug 31, 1984 Aug Sep Sep Oct Aug Aug Sep Apr 31, 17, 17, 11, 30, 30, 24, 12, 1984 1984 1984 1984 1984 1984 1984 1984

Apr 12, 1984 Oct 11, 1984

GLUCAMIDE TEVA

CHLORPROTHIXENE
CONCENTRATE; ORAL TARACTAN ROCHE INJECTABLE; INJECTION TARACTAN ROCHE TABLET; ORAL TARACTAN ROCHE

100MG/5ML

N016149

002

12.5MG/ML

N012487

001

10MG 25MG 50MG 100MG

N012486 N012486 N012486 N012486

005 004 003 001

CHLORTETRACYCLINE HYDROCHLORIDE
OINTMENT; OPHTHALMIC AUREOMYCIN LEDERLE

1%

N050404

001

CHLORTHALIDONE
TABLET; ORAL CHLORTHALIDONE ABBOTT ASCOT CLONMEL HLTHCARE IVAX PHARMS

KV PHARM MUTUAL PHARM

PIONEER PHARMS PUREPAC PHARM SANDOZ

25MG 50MG 25MG 50MG 25MG 50MG 25MG 25MG 50MG 50MG 25MG 50MG 25MG 25MG 25MG 50MG 50MG 50MG 50MG 25MG 50MG 25MG 50MG

A087364 A087384 A087698 A087699 A087451 A087450 A087555 A088164 A087176 A087947 A087311 A087312 A087292 A089285 A089738 A087293 A089286 A089739 A089591 A088139 A088140 A087380 A087118

001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001

Oct 20, 1982 Oct 20, 1982

Jan 09, 1984 Feb 27, 1984

Jul 21, 1986 Sep 19, 1988 Jul Sep Jul Jul Aug 21, 19, 21, 16, 11, 1986 1988 1988 1986 1983

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

CHLORTHALIDONE
TABLET; ORAL CHLORTHALIDONE SANDOZ SUPERPHARM TEVA USL PHARMA VANGARD WARNER CHILCOTT WATSON LABS

6 - 79 (of 346)

50MG 25MG 50MG 50MG 25MG 50MG 25MG 50MG 25MG 50MG 25MG 25MG 25MG 25MG 50MG 50MG 50MG 50MG 25MG 50MG 25MG 25MG

A087381 A087473 A087247 A088651 A089051 A089052 A088012 A088073 A087515 A087516 A087050 A087100 A087296 A087706 A087029 A087082 A087521 A087689 N012283 N012283 A088051 N019574

001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 004 003 001 002

Feb Feb May Jun Jun Jul Mar Jan Feb

09, 09, 30, 01, 01, 14, 25, 24, 09,

1983 1983 1985 1987 1987 1982 1983 1983 1983

HYGROTON SANOFI AVENTIS US THALITONE MONARCH PHARMS

Nov 12, 1982 Feb 12, 1992

CHLORTHALIDONE; CLONIDINE HYDROCHLORIDE

TABLET; ORAL CLONIDINE HYDROCHLORIDE AND CHLORTHALIDONE PAR PHARM 15MG;0.1MG 15MG;0.2MG 15MG;0.3MG COMBIPRES BOEHRINGER INGELHEIM 15MG;0.1MG 15MG;0.2MG 15MG;0.3MG

A071179 A071178 A071142 N017503 N017503 N017503

001 001 001 001 002 003

Dec 16, 1987 Dec 16, 1987 Dec 16, 1987

Apr 10, 1984

CHLORTHALIDONE; METOPROLOL TARTRATE

CAPSULE; ORAL LOPRESSIDONE NOVARTIS

25MG;100MG 25MG;200MG

N019451 N019451

001 002

Dec 31, 1987 Dec 31, 1987

CHLORTHALIDONE; RESERPINE
TABLET; ORAL DEMI-REGROTON SANOFI AVENTIS US REGROTON SANOFI AVENTIS US

25MG;0.125MG 50MG;0.25MG

N015103 N015103

002 001

CHLORZOXAZONE
TABLET; ORAL CHLORZOXAZONE ACTAVIS TOTOWA MUTUAL PHARM OHM LABS PAR PHARM PIONEER PHARMS

250MG 500MG 500MG 250MG 500MG 250MG 250MG 500MG

A088928 A040113 A089970 A081298 A081299 A087981 A089592 A089948

001 001 001 001 001 001 001 001

May Sep Sep Dec Dec Sep Jan Jan

08, 29, 27, 29, 29, 20, 06, 06,

1987 1995 1990 1993 1993 1983 1989 1989

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DISCONTINUED DRUG PRODUCT LIST

CHLORZOXAZONE
TABLET; ORAL CHLORZOXAZONE SANDOZ WATSON LABS

6 - 80 (of 346)

250MG 500MG 250MG 250MG 500MG 250MG 500MG

A089852 A089853 A086901 A086948 A081019 N011300 A081008

001 001 001 001 001 003 001

May 04, 1988 May 04, 1988 Aug 09, 1982 Jul 29, 1991

PARAFLEX ORTHO MCNEIL PHARM STRIFON FORTE DSC FERNDALE LABS

Dec 23, 1988

CHOLESTYRAMINE
BAR, CHEWABLE; ORAL CHOLYBAR PARKE DAVIS POWDER; ORAL CHOLESTYRAMINE IVAX SUB TEVA PHARMS TEVA TEVA PHARMS CHOLESTYRAMINE LIGHT TEVA TEVA PHARMS QUESTRAN BRISTOL MYERS QUESTRAN LIGHT BRISTOL MYERS TABLET; ORAL QUESTRAN APOTHECON

EQ 4GM RESIN/BAR EQ 4GM RESIN/BAR

A071621 A071739

001 001

May 26, 1988 May 26, 1988

EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ

4GM 4GM 4GM 4GM 4GM 4GM 4GM 4GM 4GM 4GM

RESIN/PACKET RESIN/SCOOPFUL RESIN/PACKET RESIN/SCOOPFUL RESIN/PACKET RESIN/SCOOPFUL RESIN/PACKET RESIN/SCOOPFUL RESIN/PACKET RESIN/SCOOPFUL

A074771 A074771 A074347 A074347 A074554 A074554 A074348 A074348 A074555 A074555 N016640 N016640 N019669 N019669

001 002 001 002 001 002 001 002 001 002 001 003 001 003

Jul Jul May May Oct Oct May May Sep Sep

09, 09, 28, 28, 02, 02, 28, 28, 30, 30,

1997 1997 1998 1998 1996 1996 1998 1998 1998 1998

EQ 4GM RESIN/PACKET EQ 4GM RESIN/SCOOPFUL EQ 4GM RESIN/PACKET EQ 4GM RESIN/SCOOPFUL

Dec 05, 1988 Dec 05, 1988

EQ 800MG RESIN EQ 1GM RESIN

A073403 A073403

002 001

Dec 27, 1999 Apr 28, 1994

CHORIOGONADOTROPIN ALFA
INJECTABLE; INJECTION OVIDREL EMD SERONO

0.25MG/VIAL

N021149

001

Sep 20, 2000

CHROMIC CHLORIDE
INJECTABLE; INJECTION CHROMIC CHLORIDE ABRAXIS PHARM

EQ 0.004MG CHROMIUM/ML

N019271

001

May 05, 1987

CHROMIC PHOSPHATE P-32

INJECTABLE; INJECTION PHOSPHOCOL P32 MALLINCKRODT

5mCi/ML

N017084

001

CHYMOPAPAIN
INJECTABLE; INJECTION CHYMODIACTIN CHART MEDCL

4,000 UNITS/VIAL 10,000 UNITS/VIAL

N018663 N018663

002 001

Aug 21, 1984 Nov 10, 1982

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DISCONTINUED DRUG PRODUCT LIST

CHYMOPAPAIN
INJECTABLE; INJECTION DISCASE ABBOTT

6 - 81 (of 346)

12,500 UNITS/VIAL

N018625

001

Jan 18, 1984

CHYMOTRYPSIN
FOR SOLUTION; OPHTHALMIC ALPHA CHYMAR SOLA BARNES HIND CATARASE CIBA NOVARTIS ZOLYSE ALCON

750 UNITS/VIAL 300 UNITS/VIAL 150 UNITS/VIAL 750 UNITS/VIAL

N011837 N016938 N018121 N011903

001 001 001 001

CILASTATIN SODIUM; IMIPENEM

INJECTABLE; INJECTION PRIMAXIN MERCK

EQ 750MG BASE/VIAL;750MG/VIAL

N050630

002

Dec 14, 1990

CILOSTAZOL
TABLET; ORAL CILOSTAZOL ACTAVIS TOTOWA IVAX SUB TEVA PHARMS MUTUAL PHARM

100MG 100MG 50MG 100MG

A077028 A077020 A077208 A077208

002 002 002 001

Nov Mar Mar Mar

26, 01, 29, 29,

2004 2005 2006 2006

CIMETIDINE
SUSPENSION; ORAL TAGAMET HB 200 GLAXOSMITHKLINE TABLET; ORAL CIMETIDINE ENDO PHARMS

200MG/20ML

N020951

001

Jul 09, 1999

IVAX SUB TEVA PHARMS

LEK PHARMS

PERRIGO ROXANE

SANDOZ

TEVA

200MG 300MG 400MG 800MG 200MG 300MG 400MG 800MG 100MG 200MG 200MG 300MG 400MG 800MG 100MG 300MG 400MG 800MG 200MG 300MG 400MG 800MG 200MG 300MG 400MG 800MG 100MG

A074281 A074281 A074281 A074329 A074401 A074401 A074401 A074402 A075122 A074250 A075122 A074250 A074250 A074250 A074972 A074361 A074361 A074371 A074100 A074100 A074100 A074100 A074365 A074365 A074365 A074365 N020238

001 002 003 001 001 002 003 001 001 001 002 002 003 004 001 001 002 001 001 002 003 004 001 002 003 004 001

May May May May May May May May Jun Jun Jun Jun Jun Jun Jun Dec Dec Dec Jan Jan Jan Jan Feb Feb Feb Feb

17, 17, 17, 17, 30, 30, 30, 30, 19, 29, 19, 29, 29, 29, 19, 23, 23, 23, 31, 31, 31, 31, 28, 28, 28, 28,

1994 1994 1994 1994 1995 1995 1995 1995 1998 1995 1998 1995 1995 1995 1998 1994 1994 1994 1995 1995 1995 1995 1995 1995 1995 1995

TAGAMET HB GLAXOSMITHKLINE

Jun 19, 1995

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

CIMETIDINE HYDROCHLORIDE
INJECTABLE; INJECTION CIMETIDINE HYDROCHLORIDE ENDO PHARMS EQ 300MG BASE/2ML A074005 HOSPIRA EQ 300MG BASE/2ML A074296 EQ 300MG BASE/2ML A074412 EQ 300MG BASE/2ML A074422 LUITPOLD EQ 300MG BASE/2ML A074353 TEVA PARENTERAL EQ 300MG BASE/2ML A074252 CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HOSPIRA EQ 6MG BASE/ML A074269 EQ 90MG BASE/100ML A074468 EQ 120MG BASE/100ML A074468 EQ 180MG BASE/100ML A074468 EQ 240MG BASE/100ML A074468 EQ 360MG BASE/100ML A074468 EQ 480MG BASE/100ML A074468 TAGAMET GLAXOSMITHKLINE EQ 300MG BASE/2ML N017939 TAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER GLAXOSMITHKLINE EQ 6MG BASE/ML N019434 SOLUTION; ORAL CIMETIDINE HYDROCHLORIDE ACTAVIS MID ATLANTIC EQ 300MG BASE/5ML A074176 DURAMED PHARMS BARR EQ 300MG BASE/5ML A075110 ENDO PHARMS EQ 300MG BASE/5ML A074251 ROXANE EQ 300MG BASE/5ML A074541 TEVA PHARMS EQ 300MG BASE/5ML A074859 TAGAMET GLAXOSMITHKLINE EQ 300MG BASE/5ML N017924

6 - 82 (of 346)

001 001 001 001 001 001 001 005 006 003 004 001 002 002 001

Aug Mar Mar Jan Dec Nov Dec Dec Dec Dec Dec Dec Dec

31, 28, 28, 31, 20, 26, 27, 29, 29, 29, 29, 29, 29,

1994 1997 1997 1995 1994 1997 1994 1994 1994 1994 1994 1994 1994

Oct 31, 1985

001 001 001 001 001 001

Jun Jun Dec Aug Jul

01, 18, 22, 05, 09,

1994 1998 1994 1997 1998

CINOXACIN
CAPSULE; ORAL CINOBAC LILLY CINOXACIN TEVA

250MG 500MG 250MG 500MG

N018067 N018067 A073005 A073006

001 002 001 001 Feb 28, 1992 Feb 28, 1992

CIPROFLOXACIN
INJECTABLE; INJECTION CIPRO BAYER HLTHCARE 1200MG/120ML (10MG/ML) CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER BAYER PHARMS 200MG/100ML CIPROFLOXACIN APP PHARMS 200MG/20ML (10MG/ML) 400MG/40ML (10MG/ML) BEDFORD LABS 200MG/20ML (10MG/ML) 400MG/40ML (10MG/ML) 1200MG/120ML (10MG/ML) CIPROFLOXACIN IN DEXTROSE 5% HIKMA FARMACEUTICA 200MG/100ML CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER BEDFORD 200MG/100ML 400MG/200ML TEVA PHARMS 200MG/100ML 400MG/200ML

N019847 N019858 A076484 A076484 A076992 A076992 A076993 A076757 A078114 A078114 A077138 A077138

003 001 001 002 001 002 001 001 001 002 001 002

Dec 26, 1990 Dec 26, 1990 Aug Aug Aug Aug Aug 28, 28, 28, 28, 28, 2006 2006 2006 2006 2006

Apr 21, 2008 Mar Mar Mar Mar 18, 18, 18, 18, 2008 2008 2008 2008

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

CIPROFLOXACIN HYDROCHLORIDE
TABLET; ORAL CIPROFLOXACIN HYDROCHLORIDE BARR EQ 250MG EQ 500MG EQ 750MG NOSTRUM LABS EQ 250MG EQ 500MG EQ 750MG SANDOZ EQ 100MG EQ 250MG EQ 250MG EQ 500MG EQ 500MG EQ 750MG EQ 750MG TEVA EQ 250MG EQ 500MG EQ 750MG TABLET, EXTENDED RELEASE; ORAL PROQUIN XR DEPOMED INC EQ 500MG

6 - 83 (of 346)

BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE

A074124 A074124 A074124 A076138 A076138 A076138 A075939 A075939 A076593 A075939 A076593 A075939 A076593 A076136 A076136 A076136

001 002 003 001 002 003 001 002 002 003 003 004 004 001 002 003

Jun Jun Jun Jun Jun Jun Mar Jun Jun Jun Jun Jun Jun Jun Jun Jun

09, 09, 09, 09, 09, 09, 03, 09, 09, 09, 09, 09, 09, 09, 09, 09,

2004 2004 2004 2004 2004 2004 2005 2004 2004 2004 2004 2004 2004 2004 2004 2004

BASE

N021744

001

May 19, 2005

CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE

TABLET, EXTENDED RELEASE; ORAL CIPROFLOXACIN EXTENDED RELEASE SANDOZ 212.6MG;EQ 287.5MG BASE

A078712

001

Dec 11, 2007

CISAPRIDE MONOHYDRATE
SUSPENSION; ORAL PROPULSID JANSSEN PHARMS TABLET; ORAL PROPULSID JANSSEN PHARMS

EQ 1MG BASE/ML

N020398

001

Sep 15, 1995

EQ 10MG BASE EQ 20MG BASE TABLET, ORALLY DISINTEGRATING; ORAL PROPULSID QUICKSOLV JANSSEN PHARMA EQ 20MG BASE

N020210 N020210

001 002

Jul 29, 1993 Dec 23, 1993

N020767

001

Nov 07, 1997

CISPLATIN
INJECTABLE; INJECTION CISPLATIN BEDFORD PLATINOL CORDEN PHARMA PLATINOL-AQ CORDEN PHARMA

10MG/VIAL 50MG/VIAL 10MG/VIAL 50MG/VIAL 0.5MG/ML 1MG/ML

A074713 A074713 N018057 N018057 N018057 N018057

001 002 001 002 003 004

Nov 14, 2000 Nov 14, 2000

Jul 18, 1984 Nov 08, 1988

CITALOPRAM HYDROBROMIDE
SOLUTION; ORAL CITALOPRAM HYDROBROMIDE APOTEX INC EQ 10MG BASE/5ML TABLET; ORAL CELEXA FOREST LABS EQ 60MG BASE CITALOPRAM HYDROBROMIDE ACTAVIS ELIZABETH EQ 10MG BASE EQ 20MG BASE EQ 40MG BASE MUTUAL PHARM EQ 10MG BASE

A077601

001

Nov 15, 2005

N020822 A077033 A077033 A077033 A077052

004 001 002 003 001

Jul 17, 1998 Oct Oct Oct Jul 28, 28, 28, 03, 2004 2004 2004 2006

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

CITALOPRAM HYDROBROMIDE
TABLET; ORAL CITALOPRAM HYDROBROMIDE MUTUAL PHARM EQ 20MG BASE EQ 40MG BASE ROXANE EQ 10MG BASE EQ 20MG BASE EQ 40MG BASE SANDOZ EQ 10MG BASE EQ 20MG BASE EQ 40MG BASE TARO EQ 10MG BASE EQ 20MG BASE EQ 40MG BASE TEVA PHARMS EQ 10MG BASE EQ 20MG BASE EQ 40MG BASE TABLET, ORALLY DISINTEGRATING; ORAL CITALOPRAM HYDROBROMIDE BIOVAIL LABS INTL EQ 10MG BASE EQ 20MG BASE EQ 40MG BASE

6 - 84 (of 346)

A077052 A077052 A077041 A077041 A077041 A077040 A077040 A077040 A077278 A077278 A077278 A077213 A077213 A077213

002 003 001 002 003 001 002 003 001 002 003 001 002 003

Jul Jul Nov Nov Nov Aug Aug Aug Mar Mar Mar Mar Mar Mar

03, 03, 23, 23, 23, 17, 17, 17, 22, 22, 22, 31, 31, 31,

2006 2006 2004 2004 2004 2005 2005 2005 2006 2006 2006 2006 2006 2006

N021763 N021763 N021763

001 002 003

Dec 20, 2005 Dec 20, 2005 Dec 20, 2005

CITRIC ACID; MAGNESIUM OXIDE; SODIUM CARBONATE

SOLUTION; IRRIGATION IRRIGATING SOLUTION G IN PLASTIC CONTAINER BAXTER HLTHCARE 3.24GM/100ML;380MG/100ML;430MG/100ML UROLOGIC G IN PLASTIC CONTAINER HOSPIRA 3.24GM/100ML;380MG/100ML;430MG/100ML

N018519 N018904

001 001

Jun 22, 1982 May 27, 1983

CLARITHROMYCIN
FOR SUSPENSION; ORAL BIAXIN ABBOTT TABLET; ORAL CLARITHROMYCIN IVAX SUB TEVA PHARMS

187MG/5ML

N050698

003

Sep 30, 1998

250MG 500MG TABLET, EXTENDED RELEASE; ORAL CLARITHROMYCIN RANBAXY 1GM

A065137 A065137

001 002

May 31, 2005 May 31, 2005

A065210

001

Jan 26, 2005

CLEMASTINE FUMARATE
SYRUP; ORAL CLEMASTINE FUMARATE ACTAVIS MID ATLANTIC TEVA PHARMS TAVIST NOVARTIS TABLET; ORAL CLEMASTINE FUMARATE TEVA TAVIST NOVARTIS TAVIST-1 NOVARTIS

EQ 0.5MG BASE/5ML EQ 0.5MG BASE/5ML EQ 0.5MG BASE/5ML

A074075 A073095 N018675

001 001 001

Oct 31, 1993 Apr 21, 1992 Jun 28, 1985

1.34MG 1.34MG 2.68MG 1.34MG 1.34MG

A073282 A073282 N017661 N017661 N017661

001 002 001 002 003

Jan 31, 1992 Dec 03, 1992

Aug 21, 1992

CLEMASTINE FUMARATE; PHENYLPROPANOLAMINE HYDROCHLORIDE

TABLET, EXTENDED RELEASE; ORAL TAVIST-D NOVARTIS EQ 1MG BASE;75MG 1.34MG;75MG

N018298 N018298

001 002

Dec 15, 1982 Aug 21, 1992

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

CLEMASTINE FUMARATE; PHENYLPROPANOLAMINE HYDROCHLORIDE
TABLET, EXTENDED RELEASE; ORAL TAVIST-D NOVARTIS 1.34MG;75MG

6 - 85 (of 346)

N020640

001

Aug 09, 1996

CLIDINIUM BROMIDE
CAPSULE; ORAL QUARZAN ROCHE

2.5MG 5MG

N010355 N010355

001 002

CLINDAMYCIN HYDROCHLORIDE
CAPSULE; ORAL CLEOCIN PHARMACIA AND UPJOHN

EQ EQ CLINDAMYCIN HYDROCHLORIDE TEVA EQ WATSON LABS EQ

75MG BASE 150MG BASE 75MG BASE 75MG BASE

A061809 A061809 A063027 A063082

001 002 001 001 Sep 20, 1989 Jul 31, 1991

CLINDAMYCIN PALMITATE HYDROCHLORIDE

FOR SOLUTION; ORAL CLEOCIN PHARMACIA AND UPJOHN

EQ 75MG BASE/5ML

A061827

001

CLINDAMYCIN PHOSPHATE
CREAM; VAGINAL CLEOCIN PHARMACIA AND UPJOHN INJECTABLE; INJECTION CLEOCIN PHOSPHATE PHARMACIA AND UPJOHN CLINDAMYCIN PHOSPHATE ABRAXIS PHARM ASTRAZENECA BAXTER HLTHCARE

EQ 2% BASE

N050680

001

Aug 11, 1992

EQ 150MG BASE/ML

A061839 A062747 A062928 A062806 A062953 A063068 A063163 A062908 A062905 A062913 A062819 A062852 A063041 A063282 A062900 A063079 N050636 A065027 A065027 A065027 N050648 N050648 N050648

001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 002 003 001 002 003 Jun Feb Oct Apr Aug Jun Feb May Oct Mar Mar Dec May Jun Mar 03, 13, 15, 21, 28, 30, 01, 09, 20, 15, 17, 29, 29, 08, 05, 1988 1989 1987 1988 1989 1994 1989 1988 1988 1988 1988 1989 1992 1988 1990

EQ 150MG BASE/ML EQ 150MG BASE/ML EQ 150MG BASE/ML EQ 150MG BASE/ML EQ 150MG BASE/ML BEDFORD EQ 150MG BASE/ML BRISTOL MYERS SQUIBB EQ 150MG BASE/ML LOCH EQ 150MG BASE/ML MARSAM PHARMS LLC EQ 150MG BASE/ML SOLOPAK EQ 150MG BASE/ML EQ 150MG BASE/ML TEVA PARENTERAL EQ 150MG BASE/ML EQ 150MG BASE/ML WATSON LABS EQ 150MG BASE/ML EQ 150MG BASE/ML CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% ABRAXIS PHARM EQ 12MG BASE/ML CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER ABBOTT EQ 6MG BASE/ML EQ 12MG BASE/ML EQ 18MG BASE/ML BAXTER HLTHCARE EQ 6MG BASE/ML EQ 12MG BASE/ML EQ 900MG BASE/100ML SOLUTION; TOPICAL CLEOCIN T PHARMACIA AND UPJOHN EQ 1% BASE CLINDAMYCIN PHOSPHATE ACTAVIS MID ATLANTIC EQ 1% BASE BOCA PHARMA EQ 1% BASE

Dec 22, 1989 Jun Jun Jun Dec Dec Dec 29, 29, 29, 29, 29, 29, 2001 2001 2001 1989 1989 1989

A062363 A062811 A062930

001 001 001

Feb 08, 1982 Sep 01, 1988 Jun 28, 1989

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

CLINDAMYCIN PHOSPHATE
SOLUTION; TOPICAL CLINDAMYCIN PHOSPHATE COPLEY PHARM COREPHARMA

6 - 86 (of 346)

EQ 1% BASE EQ 1% BASE

A062944 A064108

001 001

Jan 11, 1989 Sep 27, 1996

CLIOQUINOL; NYSTATIN
OINTMENT; TOPICAL NYSTAFORM BAYER PHARMS

10MG/GM;100,000 UNITS/GM

N050235

001

CLOBETASOL PROPIONATE
CREAM; TOPICAL CLOBETASOL PROPIONATE ACTAVIS MID ATLANTIC 0.05% COREPHARMA 0.05% CLOBETASOL PROPIONATE (EMOLLIENT) COREPHARMA 0.05% OINTMENT; TOPICAL CLOBETASOL PROPIONATE ACTAVIS MID ATLANTIC 0.05% COREPHARMA 0.05% SOLUTION; TOPICAL CLOBETASOL PROPIONATE ACTAVIS MID ATLANTIC 0.05%

A074139 A075338 A075733

001 001 001

Aug 03, 1994 Feb 09, 2001 Aug 22, 2001

A074128 A075057

001 001

Aug 03, 1994 Aug 12, 1998

A074331

001

Dec 15, 1995

CLOFAZIMINE
CAPSULE; ORAL LAMPRENE NOVARTIS

100MG

N019500

001

Dec 15, 1986

CLOFIBRATE
CAPSULE; ORAL ATROMID-S WYETH AYERST CLOFIBRATE BANNER PHARMACAPS SANDOZ TEVA USL PHARMA WATSON LABS

500MG 500MG 500MG 500MG 500MG 500MG

N016099 A073396 A072191 A072600 A070531 A071603

002 001 001 001 001 001 Mar May Jul Jun Sep 20, 02, 25, 16, 18, 1992 1988 1991 1986 1987

CLOMIPHENE CITRATE
TABLET; ORAL MILOPHENE MILEX

50MG

A072196

001

Dec 20, 1988

CLOMIPRAMINE HYDROCHLORIDE
CAPSULE; ORAL CLOMIPRAMINE HYDROCHLORIDE SANDOZ 25MG 50MG 75MG TEVA 25MG 50MG 75MG WATSON LABS 25MG 25MG 50MG 50MG 75MG 75MG

A074953 A074953 A074953 A074849 A074849 A074849 A074600 A074751 A074600 A074751 A074600 A074751

001 002 003 001 002 003 001 001 002 002 003 003

Jun Jun Jun Apr Apr Apr Nov Sep Nov Sep Nov Sep

25, 25, 25, 04, 04, 04, 27, 30, 27, 30, 27, 30,

1997 1997 1997 1997 1997 1997 1996 1998 1996 1998 1996 1998

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

CLONAZEPAM
TABLET; ORAL CLONAZEPAM SANDOZ

6 - 87 (of 346)

TEVA

0.5MG 1MG 2MG 0.5MG 1MG 2MG

A074925 A074925 A074925 A074920 A074920 A074920 N017533 N017533

001 002 003 001 002 003 005 006

Sep Sep Sep Aug Aug Aug

30, 30, 30, 04, 04, 04,

1997 1997 1997 1998 1998 1998

0.125MG 0.25MG TABLET, ORALLY DISINTEGRATING; ORAL KLONOPIN RAPIDLY DISINTEGRATING ROCHE 0.125MG 0.25MG 0.5MG 1MG 2MG

KLONOPIN ROCHE

Apr 09, 1997 Apr 09, 1997

N020813 N020813 N020813 N020813 N020813

001 002 003 004 005

Dec Dec Dec Dec Dec

23, 23, 23, 23, 23,

1997 1997 1997 1997 1997

CLONIDINE
SUSPENSION, EXTENDED RELEASE; ORAL CLONIDINE TRIS PHARMA INC EQ 0.09MG BASE/ML TABLET, EXTENDED RELEASE; ORAL CLONIDINE TRIS PHARMA INC EQ 0.17MG BASE EQ 0.26MG BASE

N022499

001

Dec 03, 2009

N022500 N022500

001 002

Dec 03, 2009 Dec 03, 2009

CLONIDINE HYDROCHLORIDE
TABLET; ORAL CLONIDINE HYDROCHLORIDE AM THERAP 0.1MG 0.2MG 0.3MG DURAMED PHARMS BARR 0.1MG 0.2MG 0.3MG INTERPHARM 0.1MG 0.2MG 0.3MG PAR PHARM 0.1MG 0.2MG 0.3MG SANDOZ 0.1MG 0.2MG 0.3MG TEVA 0.1MG 0.2MG 0.3MG WARNER CHILCOTT 0.1MG 0.2MG 0.3MG WATSON LABS 0.1MG 0.1MG 0.2MG 0.2MG 0.3MG TABLET, EXTENDED RELEASE; ORAL JENLOGA SHIONOGI INC 0.1MG 0.2MG KAPVAY SHIONOGI INC 0.2MG

A070881 A070882 A070883 A071103 A071102 A071101 A071252 A071253 A071254 A070461 A070460 A070459 A070887 A070886 A071294 A070747 A070702 A070659 A072138 A072139 A072140 A070395 A070965 A070396 A070964 A070397

001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001

Jul Jul Jul Aug Aug Aug Oct Oct Oct Jul Jul Jul Aug Aug Aug Jul Jul Jul Jun Jun Jun Mar Jul Mar Jul Mar

08, 08, 08, 14, 14, 14, 01, 01, 01, 08, 08, 08, 31, 31, 31, 08, 08, 08, 13, 13, 13, 23, 08, 23, 08, 23,

1986 1986 1986 1986 1986 1986 1986 1986 1986 1986 1986 1986 1988 1988 1988 1986 1986 1986 1988 1988 1988 1987 1986 1987 1986 1987

N022331 N022331 N022331

001 002 004

Sep 30, 2009 May 25, 2010 Sep 28, 2010

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

CLOPIDOGREL BISULFATE
TABLET; ORAL CLOPIDOGREL BISULFATE DR REDDYS LABS INC

6 - 88 (of 346)

EQ 75MG BASE

A076273

001

Jan 14, 2008

CLORAZEPATE DIPOTASSIUM
CAPSULE; ORAL CLORAZEPATE DIPOTASSIUM ABLE 3.75MG 7.5MG 15MG AM THERAP 3.75MG 7.5MG 15MG CLONMEL HLTHCARE 3.75MG 7.5MG 15MG GD SEARLE LLC 3.75MG 7.5MG 15MG MYLAN 3.75MG 7.5MG 15MG PUREPAC PHARM 3.75MG 7.5MG 15MG QUANTUM PHARMICS 3.75MG 7.5MG 15MG SANDOZ 3.75MG 7.5MG 15MG USL PHARMA 3.75MG 7.5MG 15MG WARNER CHILCOTT 3.75MG 7.5MG 15MG WATSON LABS 3.75MG 7.5MG 15MG TRANXENE LUNDBECK INC 3.75MG 7.5MG 15MG TABLET; ORAL CLORAZEPATE DIPOTASSIUM ABLE 3.75MG 7.5MG 15MG AM THERAP 3.75MG 7.5MG 15MG LEDERLE 3.75MG 7.5MG 15MG PUREPAC PHARM 3.75MG 7.5MG 15MG QUANTUM PHARMICS 3.75MG 7.5MG 15MG SANDOZ 3.75MG

A071777 A071778 A071779 A071429 A071430 A071431 A071742 A071743 A071744 A071727 A071728 A071729 A071509 A071510 A071511 A071924 A071925 A071926 A071549 A071550 A071522 A072219 A072220 A072112 A071242 A071243 A071244 A071774 A071775 A071776 A071878 A071879 A071860 N017105 N017105 N017105

001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 002 003

Jul Jul Jul Jun Jun Jun Dec Dec Dec Dec Dec Dec Oct Oct Oct Apr Apr Apr Sep Sep Sep Aug Aug Aug Jun Jun Jun Mar Mar Mar Mar Mar Mar

14, 14, 14, 23, 23, 23, 14, 14, 14, 18, 18, 18, 19, 19, 19, 25, 25, 25, 12, 12, 12, 26, 26, 26, 23, 23, 23, 01, 01, 01, 15, 15, 15,

1987 1987 1987 1987 1987 1987 1987 1987 1987 1987 1987 1987 1987 1987 1987 1988 1988 1988 1988 1988 1988 1988 1988 1988 1987 1987 1987 1988 1988 1988 1988 1988 1988

A071780 A071781 A071782 A071747 A071748 A071749 A072013 A072014 A072015 A072330 A072331 A072332 A071730 A071731 A071702 A072512

001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001

Jun Jun Jun Jun Jun Jun Dec Dec Dec Aug Aug Aug Oct Oct Oct May

26, 26, 26, 23, 23, 23, 15, 15, 15, 08, 08, 08, 26, 26, 26, 11,

1987 1987 1987 1987 1987 1987 1987 1987 1987 1988 1988 1988 1987 1987 1987 1990

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

CLORAZEPATE DIPOTASSIUM
TABLET; ORAL CLORAZEPATE DIPOTASSIUM SANDOZ 7.5MG 15MG WARNER CHILCOTT 3.75MG 7.5MG 15MG TRANXENE SD LUNDBECK INC 11.25MG 22.5MG

6 - 89 (of 346)

A072513 A072514 A071828 A071829 A071830 N017105 N017105

001 001 001 001 001 005 004

May May Mar Mar Mar

11, 11, 03, 03, 03,

1990 1990 1988 1988 1988

CLOTRIMAZOLE
CREAM; TOPICAL LOTRIMIN SCHERING PLOUGH MYCELEX BAYER PHARMS LOTION; TOPICAL LOTRIMIN SCHERING SOLUTION; TOPICAL LOTRIMIN SCHERING PLOUGH TABLET; VAGINAL GYNIX TEVA PHARMS MYCELEX-G BAYER PHARMS

1% 1%

N017619 N018183

001 001

1%

N018813

001

Feb 17, 1984

1%

N017613

001

100MG 500MG

A073249 N019069

001 001

Feb 13, 1998 Apr 19, 1985

CLOXACILLIN SODIUM
CAPSULE; ORAL CLOXACILLIN SODIUM APOTHECON TEVA CLOXAPEN GLAXOSMITHKLINE

EQ EQ EQ EQ EQ EQ EQ EQ

250MG 500MG 250MG 500MG 250MG 250MG 500MG 500MG

BASE BASE BASE BASE BASE BASE BASE BASE

A061452 A061452 A062240 A062240 A061806 A062233 A061806 A062233

001 002 001 002 001 001 002 002

FOR SOLUTION; ORAL CLOXACILLIN SODIUM TEVA TEGOPEN APOTHECON

EQ 125MG BASE/5ML EQ 125MG BASE/5ML EQ 125MG BASE/5ML EQ 125MG BASE/5ML

A062268 A062978 A061453 N050192

001 001 001 001

Apr 06, 1989

CLOZAPINE
TABLET; ORAL CLOZAPINE PAR PHARM

25MG 100MG SANDOZ 25MG 100MG TABLET, ORALLY DISINTEGRATING; ORAL FAZACLO ODT AZUR PHARMA INTL 50MG

A075162 A075162 A074546 A074546

001 002 001 002

Apr Apr Aug Aug

26, 26, 30, 30,

2005 2005 1996 1996

N021590

003

Jun 03, 2005

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 90 (of 346)

COBALT CHLORIDE CO-57; CYANOCOBALAMIN; CYANOCOBALAMIN CO-57; INTRINSIC FACTOR

N/A; N/A RUBRATOPE-57 KIT BRACCO

N/A;N/A;N/A;N/A

N016089

001

COBALT CHLORIDE CO-60; CYANOCOBALAMIN; CYANOCOBALAMIN CO-60; INTRINSIC FACTOR

N/A; N/A RUBRATOPE-60 KIT BRACCO

N/A;N/A;N/A;N/A

N016090

001

CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE

SYRUP; ORAL PHENERGAN VC W/ CODEINE ANI PHARMS 10MG/5ML;5MG/5ML;6.25MG/5ML PHERAZINE VC W/ CODEINE HALSEY 10MG/5ML;5MG/5ML;6.25MG/5ML PROMETHAZINE VC W/ CODEINE CENCI 10MG/5ML;5MG/5ML;6.25MG/5ML WOCKHARDT 10MG/5ML;5MG/5ML;6.25MG/5ML

N008306 A088870 A088816 A088896

005 001 001 001

Apr 02, 1984 Mar 02, 1987 Nov 22, 1985 Jan 04, 1985

CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE

SYRUP; ORAL PHENERGAN W/ CODEINE ANI PHARMS 10MG/5ML;6.25MG/5ML PHERAZINE W/ CODEINE HALSEY 10MG/5ML;6.25MG/5ML PROMETHAZINE W/ CODEINE CENCI 10MG/5ML;6.25MG/5ML

N008306 A088739 A088814

004 001 001

Apr 02, 1984 Dec 23, 1988 Nov 22, 1985

CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE

SYRUP; ORAL ACTIFED W/ CODEINE GLAXOSMITHKLINE 10MG/5ML;30MG/5ML;1.25MG/5ML TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES W/ CODEINE CENCI 10MG/5ML;30MG/5ML;1.25MG/5ML TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL AND CODEINE PHOSPHATE WOCKHARDT 10MG/5ML;30MG/5ML;1.25MG/5ML

N012575 A089018 A088833

003 001 001

Apr 04, 1984 Jul 23, 1986 Nov 16, 1984

COLCHICINE; PROBENECID
TABLET; ORAL COLBENEMID MERCK 0.5MG;500MG PROBEN-C WATSON LABS 0.5MG;500MG PROBENECID AND COLCHICINE BEECHAM 0.5MG;500MG IMPAX LABS 0.5MG;500MG IVAX SUB TEVA PHARMS 0.5MG;500MG SANDOZ 0.5MG;500MG PROBENECID W/ COLCHICINE LEDERLE 0.5MG;500MG WATSON LABS 0.5MG;500MG

N012383 A085552 A084321 A083720 A083734 A086130 A086954 A083221

001 001 001 002 001 001 001 001

COLESEVELAM HYDROCHLORIDE
CAPSULE; ORAL WELCHOL DAIICHI SANKYO

375MG

N021141

001

May 26, 2000

COLISTIN SULFATE
SUSPENSION; ORAL COLY-MYCIN S PARKE DAVIS

EQ 25MG BASE/5ML

N050355

001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

CONIVAPTAN HYDROCHLORIDE
INJECTABLE; IV (INFUSION) VAPRISOL ASTELLAS 20MG/4ML (5MG/ML)

6 - 91 (of 346)

N021697

001

Dec 29, 2005

COPPER
INTRAUTERINE DEVICE; INTRAUTERINE CU-7 GD SEARLE LLC 89MG TATUM-T GD SEARLE LLC 120MG

N017408 N018205

001 001

CORTICOTROPIN
INJECTABLE; INJECTION ACTH PARKEDALE ACTHAR SANOFI AVENTIS US CORTICOTROPIN ORGANICS LAGRANGE

25 UNITS/VIAL 40 UNITS/VIAL 25 UNITS/VIAL 40 UNITS/VIAL 40 UNITS/ML 80 UNITS/ML 40 UNITS/VIAL

N008317 N008317 N007504 N007504 N010831 N010831 A088772 N008372 N008975 N008975

002 004 002 003 001 002 001 006

001

002

WATSON LABS H.P. ACTHAR GEL

QUESTCOR PHARMS 40 UNITS/ML PURIFIED CORTROPHIN GEL

ORGANON USA INC 40 UNITS/ML 80 UNITS/ML

Nov 21, 1984

CORTICOTROPIN-ZINC HYDROXIDE
INJECTABLE; INJECTION CORTROPHIN-ZINC ORGANON USA INC

40 UNITS/ML

N009854

001

CORTISONE ACETATE
INJECTABLE; INJECTION CORTISONE ACETATE PHARMACIA AND UPJOHN WATSON LABS

25MG/ML 25MG/ML 25MG/ML 50MG/ML 50MG/ML 25MG/ML 50MG/ML

N008126 A083147 A085677 A083147 A085677 N007110 N007110

002 003 001 004 002 002 003

CORTONE MERCK TABLET; ORAL CORTISONE ACETATE BARR ELKINS SINN EVERYLIFE HEATHER IMPAX LABS INWOOD LABS IVAX SUB TEVA PHARMS LANNETT PANRAY PHARMACIA AND UPJOHN

PUREPAC PHARM

25MG 25MG 25MG 25MG 25MG 25MG 25MG 25MG 25MG 5MG 25MG 5MG 10MG 25MG 25MG

A083471 A080836 A084246 A085736 N009458 A080731 A080630 A083536 A080694 N008284 N008284 N008126 N008126 N008126 A080493

001 001 001 001 001 001 001 001 001 002 001 003 004 001 001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

CORTISONE ACETATE
TABLET; ORAL CORTISONE ACETATE VITARINE WATSON LABS WHITEWORTH TOWN PLSN CORTONE MERCK

6 - 92 (of 346)

25MG 25MG 25MG 25MG

A080333 A085884 A080341 N007750

001 001 001 003

CROMOLYN SODIUM
CAPSULE; INHALATION INTAL SANOFI AVENTIS US 20MG CAPSULE; ORAL GASTROCROM UCB INC 100MG CONCENTRATE; ORAL CROMOLYN SODIUM GENERA PHARMS 100MG/5ML SOLUTION; INHALATION CROMOLYN SODIUM ACTAVIS MID ATLANTIC 10MG/ML PHARMASCIENCE INC 10MG/ML ROXANE 10MG/ML INTAL KING PHARMS 10MG/ML SOLUTION/DROPS; OPHTHALMIC CROMOPTIC KING PHARMS 4% SPRAY, METERED; NASAL CROMOLYN SODIUM ACTAVIS MID ATLANTIC 5.2MG/SPRAY NASALCROM BLACKSMITH BRANDS 5.2MG/SPRAY

N016990

001

N019188

001

Dec 22, 1989

A090954

001

Dec 18, 2009

A075067 A075437 A075175 N018596

001 001 001 001

Jul 19, 1999 Apr 21, 2000 Sep 30, 1999 May 28, 1982

A075088

001

Apr 27, 1999

A074800 N020463

001 001

Jul 26, 2001 Jan 03, 1997

CRYPTENAMINE ACETATES
INJECTABLE; INJECTION UNITENSEN MEDPOINTE PHARM HLC

260CSR UNIT/ML

N008814

001

CRYPTENAMINE TANNATES
TABLET; ORAL UNITENSEN MEDPOINTE PHARM HLC

260CSR UNIT

N009217

001

CUPRIC SULFATE
INJECTABLE; INJECTION CUPRIC SULFATE ABRAXIS PHARM

EQ 0.4MG COPPER/ML

N019350

001

May 05, 1987

CYANOCOBALAMIN
GEL, METERED; NASAL NASCOBAL PAR PHARM INJECTABLE; INJECTION BERUBIGEN PHARMACIA AND UPJOHN BETALIN 12 LILLY COBAVITE WATSON LABS

0.5MG/INH

N019722

001

Nov 05, 1996

1MG/ML 0.1MG/ML 1MG/ML 0.1MG/ML 1MG/ML

N006798 A080855 A080855 A083013 A083064

001 001 002 001 001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

CYANOCOBALAMIN
INJECTABLE; INJECTION CYANOCOBALAMIN ABRAXIS PHARM

6 - 93 (of 346)

AKORN APP PHARMS BAXTER HLTHCARE BIONICHE PHARMA DELL LABS

LUITPOLD LYPHOMED SANOFI AVENTIS US SOLOPAK WARNER CHILCOTT WATSON LABS

WYETH AYERST REDISOL MERCK RUBIVITE BEL MAR

0.03MG/ML 0.1MG/ML 1MG/ML 1MG/ML 0.1MG/ML 1MG/ML 1MG/ML 0.03MG/ML 0.1MG/ML 1MG/ML 0.03MG/ML 1MG/ML 1MG/ML 1MG/ML 1MG/ML 0.1MG/ML 0.1MG/ML 1MG/ML 1MG/ML 0.1MG/ML 1MG/ML 1MG/ML 0.03MG/ML 0.05MG/ML 0.1MG/ML 0.12MG/ML 1MG/ML 0.1MG/ML 1MG/ML 1MG/ML 1MG/ML 1MG/ML

A080510 A080510 A080510 A087969 A080557 A080515 A040451 A080689 A080689 A080689 A080668 A083075 A080564 A087551 N007085 A080573 A083120 A080573 A083120 A080554 A080554 N006668 N010791 N010791 N010791 N010791 N010791 N006799 N006799 N006799 A080570 N007012

003 001 002 001 002 002 001 001 002 003 001 001 001 001 002 002 001 001 002 001 002 010 004 001 002 005 003 002 004 010 002 002

Nov 10, 1983

Sep 23, 2003

Feb 29, 1984

RUBRAMIN PC BRISTOL MYERS SQUIBB

Apr 28, 1988

RUVITE SAVAGE LABS VI-TWEL BAYER HLTHCARE SPRAY, METERED; NASAL CALOMIST PAR PHARM TABLET; ORAL CYANOCOBALAMIN WEST WARD

25MCG/SPRAY

N022102

001

Jul 27, 2007

1MG

A084264

001

CYANOCOBALAMIN CO-57
CAPSULE; ORAL RUBRATOPE-57 BRACCO

0.5-1uCi

N016089

002

CYANOCOBALAMIN CO-60
CAPSULE; ORAL RUBRATOPE-60 BRACCO

0.5-1uCi

N016090

002

CYANOCOBALAMIN; CYANOCOBALAMIN CO-57; CYANOCOBALAMIN CO-58

N/A; N/A DICOPAC KIT GE HEALTHCARE

N/A;N/A;N/A

N017406

001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

CYANOCOBALAMIN; CYANOCOBALAMIN CO-57; INTRINSIC FACTOR
N/A; N/A CYANOCOBALAMIN CO 57 SCHILLING TEST KIT MALLINCKRODT 0.1MG;0.5uCi;60MG

6 - 94 (of 346)

N016635

001

CYANOCOBALAMIN; TANNIC ACID; ZINC ACETATE

INJECTABLE; INJECTION DEPINAR ARMOUR PHARM

0.5MG/ML;2.3MG/ML;1MG/ML

N011208

001

CYCLACILLIN
FOR SUSPENSION; ORAL CYCLAPEN-W WYETH AYERST

125MG/5ML 250MG/5ML 500MG/5ML

N050508 N050508 N050508

001 002 003

TABLET; ORAL CYCLACILLIN TEVA CYCLAPEN-W WYETH AYERST

250MG 500MG 250MG 500MG

A062895 A062895 N050509 N050509

001 002 001 002

Aug 04, 1988 Aug 04, 1988

CYCLIZINE LACTATE
INJECTABLE; INJECTION MAREZINE GLAXOSMITHKLINE

50MG/ML

N009495

001

CYCLOBENZAPRINE HYDROCHLORIDE
TABLET; ORAL CYCLOBENZAPRINE HYDROCHLORIDE SANDOZ 10MG WATSON LABS 10MG 10MG

A073683 A073143 A074436

001 001 001

Feb 26, 1993 Nov 27, 1991 Nov 30, 1994

CYCLOPENTOLATE HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC AK-PENTOLATE AKORN 1% CYCLOPENTOLATE HYDROCHLORIDE ALCON UNIVERSAL 1% SOLA BARNES HIND 1% 1% PENTOLAIR PHARMAFAIR 0.5% 1%

A085555 A089162 A084150 A084863 A088643 A088150

001 001 001 001 001 001 Jan 24, 1991

Feb 09, 1987 Feb 25, 1983

CYCLOPHOSPHAMIDE
INJECTABLE; INJECTION CYCLOPHOSPHAMIDE BAXTER HLTHCARE

100MG/VIAL 200MG/VIAL 500MG/VIAL 1GM/VIAL 100MG/VIAL 200MG/VIAL 100MG/VIAL 200MG/VIAL 500MG/VIAL 1GM/VIAL

A088371 A088372 A088373 A088374 N012142 N012142 N012142 N012142 N012142 N012142

001 001 001 001 001 002 006 007 008 010

Jul Jul Jul Sep

03, 03, 03, 24,

1986 1986 1986 1986

CYTOXAN BAXTER HLTHCARE LYOPHILIZED CYTOXAN BAXTER HLTHCARE

Dec Dec Jan Sep

05, 10, 04, 24,

1985 1985 1984 1985

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

CYCLOPHOSPHAMIDE
INJECTABLE; INJECTION LYOPHILIZED CYTOXAN BAXTER HLTHCARE NEOSAR TEVA PARENTERAL

6 - 95 (of 346)

2GM/VIAL 100MG/VIAL 100MG/VIAL 200MG/VIAL 200MG/VIAL 500MG/VIAL 500MG/VIAL 1GM/VIAL 1GM/VIAL 2GM/VIAL 2GM/VIAL

N012142 A040015 A087442 A040015 A087442 A040015 A087442 A040015 A087442 A040015 A087442

009 001 001 002 002 003 003 004 004 005 005

Dec 10, 1985 Apr Feb Apr Feb Apr Feb Apr Jul Apr Mar 29, 16, 29, 16, 29, 16, 29, 08, 29, 30, 1993 1982 1993 1982 1993 1982 1993 1983 1993 1989

TABLET; ORAL CYTOXAN BAXTER HLTHCARE

25MG 50MG

N012141 N012141

002 001

CYCLOSPORINE
CAPSULE; ORAL NEORAL NOVARTIS

50MG

N050715

003

Jul 14, 1995

CYCLOTHIAZIDE
TABLET; ORAL ANHYDRON LILLY FLUIDIL PHARMACIA AND UPJOHN

2MG 2MG

N013157 N018173

002 001

CYCRIMINE HYDROCHLORIDE
TABLET; ORAL PAGITANE LILLY

1.25MG 2.5MG

N008951 N008951

001 002

CYPROHEPTADINE HYDROCHLORIDE
SYRUP; ORAL CYPROHEPTADINE HYDROCHLORIDE ACTAVIS MID ATLANTIC 2MG/5ML HALSEY 2MG/5ML MORTON GROVE 2MG/5ML NASKA 2MG/5ML PERIACTIN MERCK 2MG/5ML TABLET; ORAL CYPROHEPTADINE HYDROCHLORIDE AM THERAP 4MG ASCOT 4MG DURAMED PHARMS BARR 4MG HALSEY 4MG KV PHARM 4MG MD PHARM 4MG MYLAN 4MG PIONEER PHARMS 4MG PLIVA 4MG SANDOZ 4MG SUPERPHARM 4MG TG UNITED LABS 4MG VITARINE 4MG WATSON LABS 4MG

A086833 A089199 A087001 A089021 N013220

001 001 001 001 002

Jul 03, 1986 Nov 04, 1982 Dec 21, 1987

A088798 A087685 A088232 A089057 A086737 A087566 A086678 A087839 A088205 A086808 A087405 A088212 A087284 A085245

001 001 001 001 001 001 001 001 001 001 001 001 001 001

Feb Oct Oct Jul

15, 25, 25, 03,

1985 1982 1983 1986

Nov 10, 1982 Feb 08, 1984 Jul 26, 1983

May 26, 1983

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

CYPROHEPTADINE HYDROCHLORIDE
TABLET; ORAL CYPROHEPTADINE HYDROCHLORIDE WATSON LABS 4MG 4MG PERIACTIN MERCK 4MG

6 - 96 (of 346)

A086165 A086580 N012649

001 001 001

CYSTEINE HYDROCHLORIDE
INJECTABLE; INJECTION CYSTEINE HYDROCHLORIDE HOSPIRA

7.25%

N019523

001

Oct 22, 1986

CYTARABINE
INJECTABLE; INJECTION CYTARABINE TEVA PARENTERAL

100MG/VIAL 500MG/VIAL 1GM/VIAL 2GM/VIAL

N016793 N016793 N016793 N016793

001 002 003 004

Dec 21, 1987 Dec 21, 1987

DACARBAZINE
INJECTABLE; INJECTION DACARBAZINE ABRAXIS PHARM

100MG/VIAL 200MG/VIAL

A070962 A070990

001 001

Aug 28, 1986 Aug 28, 1986

DALFOPRISTIN; QUINUPRISTIN
INJECTABLE; IV (INFUSION) SYNERCID KING PHARMS 420MG/VIAL;180MG/VIAL

N050748

002

Aug 24, 2000

DALTEPARIN SODIUM
INJECTABLE; INJECTION FRAGMIN EISAI INC

7,500 IU/0.75ML

N020287

008

Apr 04, 2002

DANAPAROID SODIUM
INJECTABLE; INJECTION ORGARAN ORGANON USA INC

750 UNITS/0.6ML

N020430

001

Dec 24, 1996

DANAZOL
CAPSULE; ORAL DANAZOL AM THERAP DANOCRINE SANOFI AVENTIS US

200MG 50MG 100MG 200MG

A071569 N017557 N017557 N017557

001 003 004 002

Dec 30, 1987

DANTROLENE SODIUM
CAPSULE; ORAL DANTROLENE SODIUM ACTAVIS TOTOWA

25MG 50MG 100MG

A076686 A076686 A076686

001 002 003

Oct 24, 2005 Oct 24, 2005 Oct 24, 2005

DAPIPRAZOLE HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC REV-EYES FERA PHARMS 0.5%

N019849

001

Dec 31, 1990

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DISCONTINUED DRUG PRODUCT LIST

DAPTOMYCIN
INJECTABLE; IV (INFUSION) CUBICIN CUBIST 250MG/VIAL

6 - 97 (of 346)

N021572

001

Sep 12, 2003

DARUNAVIR ETHANOLATE
TABLET; ORAL PREZISTA TIBOTEC

EQ 300MG BASE

N021976

001

Jun 23, 2006

DAUNORUBICIN HYDROCHLORIDE
INJECTABLE; INJECTION CERUBIDINE SANOFI AVENTIS US EQ WYETH AYERST EQ DAUNORUBICIN HYDROCHLORIDE TEVA PARENTERAL EQ EQ

20MG BASE/VIAL 20MG BASE/VIAL 20MG BASE/VIAL 50MG BASE/VIAL

A061876 N050484 A064212 A064212

001 001 001 002 Jun 23, 1998 May 03, 1999

DECAMETHONIUM BROMIDE
INJECTABLE; INJECTION SYNCURINE GLAXOSMITHKLINE

1MG/ML

N006931

002

DEMECARIUM BROMIDE
SOLUTION/DROPS; OPHTHALMIC HUMORSOL MERCK 0.125% 0.25%

N011860 N011860

002 001

DEMECLOCYCLINE HYDROCHLORIDE
CAPSULE; ORAL DECLOMYCIN LEDERLE SYRUP; ORAL DECLOMYCIN LEDERLE TABLET; ORAL DECLOMYCIN COREPHARMA

150MG

N050262

001

75MG/5ML

N050257

001

75MG

N050261

001

DESERPIDINE
TABLET; ORAL HARMONYL ABBOTT

0.1MG 0.25MG

N010796 N010796

001 002

DESERPIDINE; HYDROCHLOROTHIAZIDE
TABLET; ORAL ORETICYL 25 ABBOTT ORETICYL 50 ABBOTT ORETICYL FORTE ABBOTT

0.125MG;25MG 0.125MG;50MG 0.25MG;25MG

N012148 N012148 N012148

001 003 002

DESERPIDINE; METHYCLOTHIAZIDE
TABLET; ORAL ENDURONYL ABBOTT ENDURONYL FORTE ABBOTT

0.25MG;5MG 0.5MG;5MG

N012775 N012775

001 002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

DESERPIDINE; METHYCLOTHIAZIDE
TABLET; ORAL METHYCLOTHIAZIDE AND DESERPIDINE WATSON LABS 0.25MG;5MG 0.5MG;5MG

6 - 98 (of 346)

A088486 A088452

001 001

Aug 10, 1984 Aug 10, 1984

DESIPRAMINE HYDROCHLORIDE
CAPSULE; ORAL PERTOFRANE SANOFI AVENTIS US

25MG 50MG

N013621 N013621

001 002

TABLET; ORAL DESIPRAMINE HYDROCHLORIDE PLIVA 25MG 50MG 75MG 100MG 150MG USL PHARMA 25MG 50MG 75MG 100MG

A071800 A071801 A071802 A071803 A071804 A071864 A071865 A071866 A071867

001 001 001 001 001 001 001 001 001

Dec Dec Dec May May Sep Sep Sep Sep

08, 08, 08, 29, 29, 09, 09, 09, 09,

1987 1987 1987 1997 1997 1987 1987 1987 1987

DESLANOSIDE
INJECTABLE; INJECTION CEDILANID-D NOVARTIS

0.2MG/ML

N009282

002

DESMOPRESSIN ACETATE
INJECTABLE; INJECTION DDAVP SANOFI AVENTIS US 0.015MG/ML DESMOPRESSIN ACETATE BEDFORD 0.004MG/ML DESMOPRESSIN ACETATE PRESERVATIVE FREE BEDFORD 0.004MG/ML SOLUTION; NASAL CONCENTRAID FERRING 0.01% SPRAY, METERED; NASAL DDAVP SANOFI AVENTIS US 0.01MG/SPRAY STIMATE CSL BEHRING 0.15MG/SPRAY

N018938 A074575 A074574

002 001 001

Apr 25, 1995 Feb 18, 2000 Feb 18, 2000

N019776

001

Dec 26, 1990

N017922 N020355

002 001

Feb 06, 1989 Mar 07, 1994

DESOGESTREL; ETHINYL ESTRADIOL

TABLET; ORAL-21 DESOGEN ORGANON USA INC DESOGESTREL AND ETHINYL DURAMED PHARMS BARR ORTHO-CEPT JANSSEN PHARMS

0.15MG;0.03MG ESTRADIOL 0.15MG;0.03MG 0.15MG;0.03MG

N020071 A075256 N020301

001 001 001

Dec 10, 1992 Aug 12, 1999 Dec 14, 1992

DESONIDE
CREAM; TOPICAL DESONIDE TEVA PHARMS

0.05%

A074027

001

Sep 28, 1992

DESOXIMETASONE
OINTMENT; TOPICAL DESOXIMETASONE ALTANA

0.25%

A073440

001

Apr 01, 1998

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DISCONTINUED DRUG PRODUCT LIST

DESOXYCORTICOSTERONE ACETATE
INJECTABLE; INJECTION DOCA ORGANON USA INC PELLET; IMPLANTATION PERCORTEN NOVARTIS

6 - 99 (of 346)

5MG/ML

N001104

001

125MG

N005151

001

DESOXYCORTICOSTERONE PIVALATE
INJECTABLE; INJECTION PERCORTEN NOVARTIS

25MG/ML

N008822

001

DEXAMETHASONE
AEROSOL; TOPICAL AEROSEB-DEX ALLERGAN HERBERT 0.01% DECASPRAY MERCK 0.04% ELIXIR; ORAL DECADRON MERCK 0.5MG/5ML DEXAMETHASONE ALPHARMA US PHARMS 0.5MG/5ML HEXADROL ORGANON USA INC 0.5MG/5ML GEL; TOPICAL DECADERM MERCK 0.1% SUSPENSION/DROPS; OPHTHALMIC DEXAMETHASONE WATSON LABS 0.1% TABLET; ORAL DECADRON MERCK 0.25MG 0.5MG 0.75MG 1.5MG 4MG 6MG DEXAMETHASONE IMPAX LABS 0.75MG MUTUAL PHARM 0.25MG 0.25MG 0.5MG 0.5MG 0.75MG 0.75MG 1.5MG 1.5MG PAR PHARM 0.25MG PHOENIX LABS NY 0.75MG PVT FORM 0.75MG ROXANE 0.25MG SANDOZ 0.75MG UPSHER SMITH 0.75MG 1.5MG WATSON LABS 0.25MG 0.5MG 0.75MG 0.75MG 0.75MG 1.5MG 1.5MG

A083296 N012731

002 002

N012376 A088997 N012674

002 001 001 Oct 10, 1986

N013538

001

A089170

001

May 09, 1989

N011664 N011664 N011664 N011664 N011664 N011664 A085376 A084013 A084764 A084084 A084766 A084081 A084765 A084086 A084763 A088149 A083806 A083420 A084614 A080399 A087534 A087533 A085455 A085458 A080968 A084457 A085818 A085456 A085840

004 001 002 003 005 006 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001

Jul 30, 1982

Apr 28, 1983

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DISCONTINUED DRUG PRODUCT LIST

DEXAMETHASONE
TABLET; ORAL DEXAMETHASONE WHITEWORTH TOWN PLSN DEXONE 0.5 SOLVAY DEXONE 0.75 SOLVAY DEXONE 1.5 SOLVAY DEXONE 4 SOLVAY HEXADROL ORGANON USA INC

6 - 100 (of 346)

0.75MG 0.5MG 0.75MG 1.5MG 4MG 0.5MG 0.75MG 1.5MG 4MG

A084327 A084991 A084993 A084990 A084992 N012675 N012675 N012675 N012675

001 001 001 001 001 004 007 009 010

DEXAMETHASONE ACETATE
INJECTABLE; INJECTION DECADRON-LA MERCK DEXAMETHASONE ACETATE WATSON LABS

EQ 8MG BASE/ML EQ 8MG BASE/ML EQ 16MG BASE/ML

N016675 A084315 A087711

001 001 001

May 24, 1982

DEXAMETHASONE SODIUM PHOSPHATE

AEROSOL; NASAL DEXACORT UCB INC EQ 0.1MG PHOSPHATE/INH AEROSOL, METERED; INHALATION DEXACORT EQ 0.1MG PHOSPHATE/INH UCB INC CREAM; TOPICAL DECADRON EQ 0.1% PHOSPHATE MERCK INJECTABLE; INJECTION DECADRON MERCK EQ 4MG PHOSPHATE/ML EQ 24MG PHOSPHATE/ML DEXACEN-4
CENT PHARMS
EQ 4MG PHOSPHATE/ML DEXAMETHASONE ABRAXIS PHARM EQ 4MG PHOSPHATE/ML APP PHARMS EQ 10MG PHOSPHATE/ML DEXAMETHASONE SODIUM PHOSPHATE AKORN EQ 4MG PHOSPHATE/ML BAXTER HLTHCARE EQ 4MG PHOSPHATE/ML BEL MAR EQ 4MG PHOSPHATE/ML DELL LABS EQ 4MG PHOSPHATE/ML INTL MEDICATION EQ 20MG PHOSPHATE/ML LYPHOMED EQ 4MG PHOSPHATE/ML TEVA PARENTERAL EQ 4MG PHOSPHATE/ML EQ 10MG PHOSPHATE/ML WATSON LABS EQ 4MG PHOSPHATE/ML EQ 4MG PHOSPHATE/ML EQ 4MG PHOSPHATE/ML EQ 10MG PHOSPHATE/ML EQ 24MG PHOSPHATE/ML WYETH AYERST EQ 4MG PHOSPHATE/ML HEXADROL ORGANON USA INC EQ 4MG PHOSPHATE/ML EQ 10MG PHOSPHATE/ML EQ 20MG PHOSPHATE/ML

N014242

001

N013413

001

N011983

002

N012071 N012071 A084342 A088448 A088469 A084493 A084282 A084752 A083161 A088522 A087065 A081125 A081126 A083702 A084355 A089169 A087668 A085606 A085641 N014694 N014694 N014694

002 004 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 002 003 004 Jan 25, 1984 Jan 25, 1984

Feb 17, 1984 Aug 31, 1990 Aug 31, 1990

Apr 09, 1986 Jul 01, 1982

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

DEXAMETHASONE SODIUM PHOSPHATE
OINTMENT; OPHTHALMIC DECADRON MERCK EQ 0.05% PHOSPHATE DEXAIR PHARMAFAIR EQ 0.05% PHOSPHATE MAXIDEX ALCON EQ 0.05% PHOSPHATE SOLUTION/DROPS; OPHTHALMIC DEXAIR PHARMAFAIR EQ 0.1% PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE SOLA BARNES HIND EQ 0.1% PHOSPHATE EQ 0.1% PHOSPHATE SOLUTION/DROPS; OPHTHALMIC, OTIC DECADRON MERCK EQ 0.1% PHOSPHATE SOLUTION/DROPS; OTIC DEXAMETHASONE SODIUM PHOSPHATE AKORN EQ 0.1% PHOSPHATE

6 - 101 (of 346)

N011977 A088071 A083342

001 001 001 Dec 28, 1982

A088433 A084170 A084173

001 001 001

Dec 15, 1983

N011984

001

A084855

001

DEXAMETHASONE SODIUM PHOSPHATE; LIDOCAINE HYDROCHLORIDE

INJECTABLE; INJECTION DECADRON W/ XYLOCAINE MERCK

EQ 4MG PHOSPHATE/ML;10MG/ML

N013334

002

DEXAMETHASONE SODIUM PHOSPHATE; NEOMYCIN SULFATE

OINTMENT; OPHTHALMIC NEODECADRON MERCK EQ 0.05% PHOSPHATE;EQ 3.5MG BASE/GM SOLUTION/DROPS; OPHTHALMIC NEODECADRON MERCK EQ 0.1% PHOSPHATE;EQ 3.5MG BASE/ML NEOMYCIN SULFATE AND DEXAMETHASONE SODIUM PHOSPHATE BAUSCH AND LOMB EQ 0.1% PHOSPHATE;EQ 3.5MG BASE/ML NEOMYCIN SULFATE-DEXAMETHASONE SODIUM PHOSPHATE ALCON UNIVERSAL EQ 0.1% PHOSPHATE;EQ 3.5MG BASE/ML PHARMAFAIR EQ 0.1% PHOSPHATE;EQ 3.5MG BASE/ML

N050324

001

N050322 A064055 A062714 A062539

001 001 001 001 Oct 30, 1995 Jul 21, 1986 Jan 10, 1985

DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

OINTMENT; OPHTHALMIC DEXACIDIN NOVARTIS 0.1%;EQ DEXASPORIN PHARMAFAIR 0.1%;EQ SUSPENSION/DROPS; OPHTHALMIC DEXACIDIN NOVARTIS 0.1%;EQ DEXASPORIN PHARMAFAIR 0.1%;EQ

3.5MG BASE/GM;10,000 UNITS/GM 3.5MG BASE/GM;10,000 UNITS/GM

A062566 A062411

001 001

Feb 22, 1985 May 16, 1983

3.5MG BASE/ML;10,000 UNITS/ML 3.5MG BASE/ML;10,000 UNITS/ML

A062544 A062428

001 001

Oct 29, 1984 May 18, 1983

DEXBROMPHENIRAMINE MALEATE
SYRUP; ORAL DISOMER SCHERING TABLET; ORAL DISOMER SCHERING

2MG/5ML

N011814

002

2MG

N011814

001

DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE

TABLET; ORAL DISOPHROL SCHERING

2MG;60MG

N012394

002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE
TABLET, EXTENDED RELEASE; BROMPHERIL COPLEY PHARM DISOBROM SANDOZ RESPORAL PIONEER PHARMS ORAL 6MG;120MG 6MG;120MG 6MG;120MG A089116 A070770 A089139

6 - 102 (of 346)

001 001 001

Jan 22, 1987 Sep 30, 1991 Jun 16, 1988

DEXCHLORPHENIRAMINE MALEATE
SYRUP; ORAL POLARAMINE SCHERING 2MG/5ML TABLET; ORAL DEXCHLORPHENIRAMINE MALEATE PLIVA 2MG POLARAMINE SCHERING 2MG

A086837

001

Jul 19, 1982

A088682 A086835

001 001

Jan 17, 1986

DEXTROAMPHETAMINE SULFATE
CAPSULE; ORAL DEXAMPEX TEVA 15MG CAPSULE, EXTENDED RELEASE; ORAL DEXTROAMPHETAMINE SULFATE ABLE 5MG 10MG 15MG ELIXIR; ORAL DEXEDRINE GLAXOSMITHKLINE 5MG/5ML TABLET; ORAL DEXAMPEX TEVA 5MG 10MG DEXEDRINE GLAXOSMITHKLINE 5MG DEXTROAMPHETAMINE SULFATE ENDO PHARMS 5MG HALSEY 10MG LANNETT 5MG 10MG 15MG MAST MM 5MG PUREPAC PHARM 5MG SANDOZ 5MG 10MG VITARINE 5MG 10MG DEXTROSTAT SHIRE 5MG 10MG FERNDEX FERNDALE LABS 5MG

A085355

001

A076814 A076814 A076814

001 002 003

Aug 25, 2004 Aug 25, 2004 Aug 25, 2004

A083902

001

A083735 A083735 A084935 A040299 A083930 A083903 A083903 A085652 A086521 A084125 A085370 A085371 A084986 A085892 A084051 A084051 A084001

001 002 001 001 001 001 003 001 001 001 001 001 001 001 001 002 001 May 13, 1999

DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE

SYRUP; ORAL PHERAZINE DM HALSEY 15MG/5ML;6.25MG/5ML PROMETHAZINE HYDROCHLORIDE AND DESTROMETHORPHAN HYDROBROMIDE ANI PHARMS 15MG/5ML;6.25MG/5ML

A088913 N011265

001 002

Mar 02, 1987 Apr 02, 1984

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

DEXTROSE
INJECTABLE; INJECTION DEXTROSE 10% IN PLASTIC CONTAINER B BRAUN 10GM/100ML MILES 10GM/100ML DEXTROSE 2.5% IN PLASTIC CONTAINER B BRAUN 2.5GM/100ML 2.5GM/100ML DEXTROSE 38.5% IN PLASTIC CONTAINER ABBOTT 38.5GM/100ML DEXTROSE 5% IN PLASTIC CONTAINER DHL 5GM/100ML DEXTROSE 60% B BRAUN 60GM/100ML DEXTROSE 60% IN PLASTIC CONTAINER B BRAUN 60GM/100ML BAXTER HLTHCARE 60GM/100ML HOSPIRA 60GM/100ML DEXTROSE 7.7% IN PLASTIC CONTAINER B BRAUN 7.7GM/100ML

6 - 103 (of 346)

N018046 N018504 N018358 N019626 N018923 N019971 N017995 N017995 N020047 N019346 N019626

001 001 001 001 001 001 002 001 002 001 003

Feb 02, 1988 Sep 19, 1984 Sep 28, 1995 Sep 22, 1982

Jul 02, 1991 Jan 25, 1985 Feb 02, 1988

DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE
INJECTABLE; INJECTION ISOLYTE P W/ DEXTROSE 5% IN PLASTIC CONTAINER B BRAUN 5GM/100ML;31MG/100ML;130MG/100ML;26MG/1 N019025 00ML;320MG/100ML

001

Dec 27, 1984

DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE

INJECTABLE; INJECTION

ISOLYTE H W/ DEXTROSE 5% IN PLASTIC CONTAINER

B BRAUN 5GM/100ML;30MG/100ML;97MG/100ML;220MG/1 N018273 00ML;140MG/100ML

001

DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE
INJECTABLE; INJECTION ISOLYTE S W/ DEXTROSE 5% IN PLASTIC CONTAINER B BRAUN 5GM/100ML;30MG/100ML;37MG/100ML;370MG/1 N018274 00ML;530MG/100ML;500MG/100ML

001

DEXTROSE; POTASSIUM CHLORIDE

INJECTABLE; POTASSIUM B BRAUN POTASSIUM B BRAUN POTASSIUM B BRAUN POTASSIUM B BRAUN INJECTION CHLORIDE 0.037% IN DEXTROSE 5% IN PLASTIC CONTAINER 5GM/100ML;37MG/100ML CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER 5GM/100ML;75MG/100ML CHLORIDE 0.11% IN DEXTROSE 5% IN PLASTIC CONTAINER 5GM/100ML;110MG/100ML CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER 5GM/100ML;220MG/100ML

N019699 N019699 N019699 N019699

001 002 003 005

Sep 29, 1989 Sep 29, 1989 Sep 29, 1989 Sep 29, 1989

DEXTROSE; POTASSIUM CHLORIDE; POTASSIUM LACTATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, MONOBASIC ANHYDROUS
INJECTABLE; INJECTION IONOSOL T AND DEXTROSE 5% IN PLASTIC CONTAINER HOSPIRA 5GM/100ML;111MG/100ML;256MG/100ML;146MG N019514 /100ML;207MG/100ML

001

May 08, 1986

DEXTROSE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE
INJECTABLE; INJECTION ISOLYTE M W/ DEXTROSE 5% IN PLASTIC CONTAINER B BRAUN 5GM/100ML;150MG/100ML;130MG/100ML;280MG N018270 /100ML;91MG/100ML

001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
INJECTABLE; INJECTION DEXTROSE 5%, SODIUM B BRAUN DEXTROSE 5%, SODIUM B BRAUN DEXTROSE 5%, SODIUM B BRAUN DEXTROSE 5%, SODIUM B BRAUN DEXTROSE 5%, SODIUM B BRAUN DEXTROSE 5%, SODIUM B BRAUN DEXTROSE 5%, SODIUM B BRAUN DEXTROSE 5%, SODIUM B BRAUN DEXTROSE 5%, SODIUM B BRAUN DEXTROSE 5%, SODIUM B BRAUN DEXTROSE 5%, SODIUM B BRAUN DEXTROSE 5%, SODIUM B BRAUN DEXTROSE 5%, SODIUM BAXTER HLTHCARE DEXTROSE 5%, SODIUM BAXTER HLTHCARE DEXTROSE 5%, SODIUM BAXTER HLTHCARE

6 - 104 (of 346)

CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.075% 5GM/100ML;75MG/100ML;200MG/100ML N018268 009 CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER 5GM/100ML;150MG/100ML;200MG/100ML N018268 004 CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER 5GM/100ML;220MG/100ML;200MG/100ML N018268 005 CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER 5GM/100ML;300MG/100ML;200MG/100ML N018268 006 CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER 5GM/100ML;75MG/100ML;330MG/100ML N018268 011 Jan 18, 1986 CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER 5GM/100ML;150MG/100ML;330MG/100ML N018268 012 Jan 18, 1986 CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER 5GM/100ML;220MG/100ML;330MG/100ML N018268 013 Jan 18, 1986 CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.30% IN PLASTIC CONTAINER 5GM/100ML;300MG/100ML;330MG/100ML N018268 014 Jan 18, 1986 CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.075% 5GM/100ML;75MG/100ML;450MG/100ML N018268 010 CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER 5GM/100ML;150MG/100ML;450MG/100ML N018268 001 CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER 5GM/100ML;220MG/100ML;450MG/100ML N018268 002 CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER 5GM/100ML;300MG/100ML;450MG/100ML N018268 003 CHLORIDE 0.45% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER 5GM/100ML;224MG/100ML;450MG/100ML N018008 003 CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC CONTAINER 5GM/100ML;300MG/100ML;450MG/100ML N018008 001 CHLORIDE 0.45% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER 5GM/100ML;75MG/100ML;450MG/100ML N018008 002

DEXTROSE; SODIUM CHLORIDE

INJECTABLE; INJECTION DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER B BRAUN 10GM/100ML;200MG/100ML DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER B BRAUN 10GM/100ML;450MG/100ML DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER B BRAUN 10GM/100ML;900MG/100ML DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER B BRAUN 2.5GM/100ML;450MG/100ML HOSPIRA 2.5GM/100ML;450MG/100ML DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER B BRAUN 2.5GM/100ML;900MG/100ML DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER ABBOTT 3.3GM/100ML;300MG/100ML DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER B BRAUN 5GM/100ML;110MG/100ML DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER B BRAUN 5GM/100ML;200MG/100ML MILES 5GM/100ML;200MG/100ML DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER ABBOTT 5GM/100ML;225MG/100ML DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER ABBOTT 5GM/100ML;300MG/100ML MILES 5GM/100ML;300MG/100ML DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER B BRAUN 5GM/100ML;330MG/100ML DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER ABBOTT 5GM/100ML;450MG/100ML B BRAUN 5GM/100ML;450MG/100ML

N018386 N018229 N018047 N018030 N018096 N018376 N018055 N018030 N018030 N018399 N019482 N019486 N018501 N018030 N019484 N018030

001 001 001 001 001 001 001 005 004 001 001 001 001 003 001 002 Oct 04, 1985 Oct 04, 1985 Oct 04, 1985

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

DEXTROSE; SODIUM CHLORIDE
INJECTABLE; INJECTION DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER MILES 5GM/100ML;450MG/100ML DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER ABBOTT 5GM/100ML;900MG/100ML B BRAUN 5GM/100ML;900MG/100ML MILES 5GM/100ML;900MG/100ML

6 - 105 (of 346)

N018400 N019483 N018026 N018500

001 001 001 001 Oct 04, 1985

DEXTROTHYROXINE SODIUM
TABLET; ORAL CHOLOXIN ABBOTT

1MG 2MG 4MG 6MG

N012302 N012302 N012302 N012302

005 002 004 006

DEZOCINE
INJECTABLE; INJECTION DALGAN ASTRAZENECA

5MG/ML 10MG/ML 15MG/ML

N019082 N019082 N019082

001 002 003

Dec 29, 1989 Dec 29, 1989 Dec 29, 1989

DIATRIZOATE MEGLUMINE
INJECTABLE; INJECTION ANGIOVIST 282 BAYER HLTHCARE CARDIOGRAFIN BRACCO DIATRIZOATE MEGLUMINE BRACCO HYPAQUE GE HEALTHCARE

60% 85% 76% 30% 60%

A087726 N011620 N010040 N016403 N016403 N010040 N010040 A087739

001 002 017 002 001 016 012 001

Sep 23, 1982

RENO-60 BRACCO 60% RENO-DIP BRACCO 30% UROVIST MEGLUMINE DIU/CT BAYER HLTHCARE 30% SOLUTION; URETERAL RENO-30 BRACCO 30% UROVIST CYSTO BAYER HLTHCARE 30% UROVIST CYSTO PEDIATRIC BAYER HLTHCARE 30% SOLUTION; URETHRAL HYPAQUE-CYSTO GE HEALTHCARE 30%

Sep 23, 1982

N010040 A087729 A087731

021 001 001 Sep 23, 1982 Sep 23, 1982

N016403

003

DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM

INJECTABLE; INJECTION ANGIOVIST 292 BAYER HLTHCARE ANGIOVIST 370 BAYER HLTHCARE DIATRIZOATE-60 INTL MEDICATION HYPAQUE-76 GE HEALTHCARE

52%;8% 66%;10% 52%;8% 66%;10%

A087724 A087723 A088166 A086505

001 001 001 001

Sep 23, 1982 Sep 23, 1982 Jun 17, 1983

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM
INJECTABLE; INJECTION HYPAQUE-M,75% GE HEALTHCARE HYPAQUE-M,90% GE HEALTHCARE MD-60 MALLINCKRODT MD-76 MALLINCKRODT RENOCAL-76 BRACCO RENOGRAFIN-60 BRACCO RENOVIST BRACCO RENOVIST II BRACCO SOLUTION; ORAL, RECTAL GASTROVIST BAYER HLTHCARE

6 - 106 (of 346)

50%;25% 60%;30% 52%;8% 66%;10% 66%;10% 52%;8% 34.3%;35% 28.5%;29.1%

N010220 N010220 A087074 A087073 A089347 N010040 N010040 N010040

003 002 001 001 001 006 020 019 Jun 01, 1988

66%;10%

A087728

001

Sep 23, 1982

DIATRIZOATE SODIUM
FOR SOLUTION; ORAL, RECTAL HYPAQUE GE HEALTHCARE 100% INJECTABLE; INJECTION HYPAQUE GE HEALTHCARE 25% 50% MD-50 MALLINCKRODT 50% UROVIST SODIUM 300 BAYER HLTHCARE 50% SOLUTION; ORAL, RECTAL HYPAQUE GE HEALTHCARE 40% SOLUTION; URETERAL HYPAQUE SODIUM 20% GE HEALTHCARE 20%

N011386

001

N009561 N009561 A087075 A087725

003 001 001 001 Sep 23, 1982

N011386

003

N009561

002

DIAZEPAM
CAPSULE, EXTENDED RELEASE; ORAL VALRELEASE ROCHE 15MG GEL; RECTAL DIASTAT VALEANT 5MG/ML (5MG/ML) 10MG/2ML (5MG/ML) 15MG/3ML (5MG/ML) 20MG/4ML (5MG/ML) INJECTABLE; INJECTION DIAZEPAM ABRAXIS PHARM 5MG/ML BAXTER HLTHCARE 5MG/ML 5MG/ML 5MG/ML 5MG/ML 5MG/ML 5MG/ML MARSAM PHARMS LLC 5MG/ML 5MG/ML 5MG/ML PARENTA PHARMS 5MG/ML

N018179

001

N020648 N020648 N020648 N020648

002 003 004 005

Jul Jul Jul Jul

29, 29, 29, 29,

1997 1997 1997 1997

A070662 A070311 A070312 A070313 A071308 A071309 A071310 A072370 A072371 A072397 A076815

001 001 001 001 001 001 001 001 001 001 001

Jun Dec Dec Dec Jul Jul Jul Jan Jan Jan Apr

25, 16, 16, 16, 17, 17, 17, 29, 29, 29, 15,

1986 1985 1985 1985 1987 1987 1987 1993 1993 1993 2004

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

DIAZEPAM
INJECTABLE; INJECTION DIAZEPAM US ARMY WARNER CHILCOTT WATSON LABS

6 - 107 (of 346)

5MG/ML 5MG/ML 5MG/ML 5MG/ML 5MG/ML 5MG/ML 5MG/ML 5MG/ML

N020124 A071613 A071614 A070911 A070912 A070930 N019287 N016087

001 001 001 001 001 001 001 001

Dec Oct Oct Aug Aug Dec

05, 22, 22, 28, 28, 01,

1990 1987 1987 1986 1986 1986

DIZAC PHARMACIA AND UPJOHN VALIUM ROCHE TABLET; ORAL DIAZEPAM ACTAVIS ELIZABETH

Jun 18, 1993

DAVA PHARMS INC DURAMED PHARMS BARR

FERNDALE LABS

HALSEY

IVAX SUB TEVA PHARMS

MARTEC USA LLC PAR PHARM

PIONEER PHARMS

ROXANE

SANDOZ

TEVA PHARMS WARNER CHILCOTT

WATSON LABS

2MG 5MG 10MG 5MG 10MG 2MG 5MG 10MG 2MG 5MG 10MG 2MG 5MG 10MG 2MG 5MG 10MG 10MG 2MG 5MG 10MG 2MG 5MG 10MG 2MG 5MG 10MG 2MG 5MG 10MG 5MG 2MG 5MG 10MG 2MG 5MG 10MG 2MG 2MG 5MG 5MG 10MG 10MG

A070781 A070706 A070707 A070227 A070228 A070894 A070895 A070896 A070903 A070904 A070905 A070987 A070996 A070956 A070360 A070361 A070362 A072402 A070462 A070463 A070464 A070787 A070788 A070776 A070356 A070357 A070358 A070302 A070303 A070304 A070153 A070209 A070210 A070222 A070456 A070457 A070458 A070423 A072431 A070424 A072432 A070425 A072433

001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001

Mar Mar Mar Sep Sep Aug Aug Aug Apr Apr Apr Aug Aug Aug Sep Sep Sep Apr Feb Feb Feb Aug Aug Aug Jun Jun Jun Dec Dec Dec Nov Sep Sep Sep Nov Nov Nov Dec Apr Dec Apr Dec Apr

19, 19, 19, 26, 26, 27, 27, 27, 01, 01, 01, 15, 15, 15, 04, 04, 04, 25, 25, 25, 25, 02, 02, 02, 17, 17, 17, 20, 20, 20, 01, 04, 04, 04, 01, 01, 01, 12, 29, 12, 29, 12, 29,

1986 1986 1986 1985 1985 1986 1986 1986 1987 1987 1987 1986 1986 1986 1985 1985 1985 1989 1986 1986 1986 1988 1988 1988 1986 1986 1986 1985 1985 1985 1985 1985 1985 1985 1985 1985 1985 1985 1988 1985 1988 1985 1988

Q-PAM QUANTUM PHARMICS

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

DIAZOXIDE
CAPSULE; ORAL PROGLYCEM TEVA BRANDED PHARM INJECTABLE; INJECTION DIAZOXIDE ABRAXIS PHARM HYPERSTAT SCHERING

6 - 108 (of 346)

50MG 100MG

N017425 N017425

001 002

15MG/ML 15MG/ML

A071519 N016996

001 001

Aug 26, 1987

DIBUCAINE HYDROCHLORIDE
INJECTABLE; INJECTION HEAVY SOLUTION NUPERCAINE NOVARTIS 2.5MG/ML

N006203

001

DICHLORPHENAMIDE
TABLET; ORAL DARANIDE TARO

50MG

N011366

001

DICLOFENAC POTASSIUM
TABLET; ORAL CATAFLAM NOVARTIS DICLOFENAC POTASSIUM MUTUAL PHARM SANDOZ WATSON LABS

25MG 50MG 50MG 50MG

N020142 A075470 A075582 A075152

001 001 001 001

Nov 24, 1993 Feb 21, 2002 Feb 23, 2001 Nov 27, 1998

DICLOFENAC SODIUM
SOLUTION/DROPS; OPHTHALMIC DICLOFENAC SODIUM FALCON PHARMS 0.1% TABLET, DELAYED RELEASE; ORAL DICLOFENAC SODIUM NOSTRUM LABS 50MG 75MG PLIVA 50MG 75MG ROXANE 25MG 50MG 75MG TEVA 50MG 75MG TEVA PHARMS 25MG 50MG 75MG VOLTAREN NOVARTIS 25MG 50MG 75MG

N020809

001

May 04, 1998

A074986 A074986 A074432 A074432 A074391 A074391 A074391 A074723 A074390 A074459 A074459 A074459 N019201 N019201 N019201

001 002 002 003 001 002 003 001 001 001 002 003 001 002 003

Feb Feb Jul Jul Jun Jun Jun Mar Aug Jun Jun Jun

26, 26, 29, 29, 29, 29, 29, 30, 15, 25, 25, 25,

1999 1999 1999 1999 1995 1995 1995 1999 1996 1997 1997 1997

Jul 28, 1988 Jul 28, 1988 Jul 28, 1988

DICLOXACILLIN SODIUM
CAPSULE; ORAL DYCILL GLAXOSMITHKLINE

EQ EQ EQ EQ

250MG 250MG 500MG 500MG

BASE BASE BASE BASE

A060254 A062238 A060254 A062238 N050011 N050011

002 001 003 002 002 003

PATHOCIL WYETH AYERST

EQ 250MG BASE EQ 500MG BASE

Mar 28, 1983

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

DICLOXACILLIN SODIUM
FOR SUSPENSION; ORAL DICLOXACILLIN SODIUM APOTHECON DYNAPEN APOTHECON PATHOCIL WYETH AYERST

6 - 109 (of 346)

EQ 62.5MG BASE/5ML EQ 62.5MG BASE/5ML EQ 62.5MG BASE/5ML

A061455 N050337 N050092

001 002 001

DICUMAROL
CAPSULE; ORAL DICUMAROL LILLY TABLET; ORAL DICUMAROL ABBOTT

25MG 50MG

N005509 N005509

003 001

25MG 50MG 100MG

N005545 N005545 N005545

003 004 005

DICYCLOMINE HYDROCHLORIDE
CAPSULE; ORAL DICYCLOMINE HYDROCHLORIDE MUTUAL PHARM 10MG PIONEER PHARMS 10MG WATSON LABS 10MG INJECTABLE; INJECTION DICYCLOMINE HYDROCHLORIDE WATSON LABS 10MG/ML SYRUP; ORAL DICYCLOMINE HYDROCHLORIDE ALPHARMA US PHARMS 10MG/5ML TABLET; ORAL DICYCLOMINE HYDROCHLORIDE MUTUAL PHARM 20MG PIONEER PHARMS 20MG WATSON LABS 20MG

A084505 A089361 A083179

001 001 001

Oct 21, 1986 Jan 10, 1989 Feb 12, 1986

A080614

001

Feb 11, 1986

A084479

001

A084600 A088585 A084361

001 001 001

Jul 29, 1985 Aug 20, 1986 Feb 06, 1986

DIDANOSINE
FOR SOLUTION; ORAL VIDEX BRISTOL MYERS SQUIBB

100MG/PACKET 167MG/PACKET 250MG/PACKET 375MG/PACKET

N020155 N020155 N020155 N020155

003 004 005 006

Oct Oct Oct Oct

09, 09, 09, 09,

1991 1991 1991 1991

TABLET, CHEWABLE; ORAL VIDEX BRISTOL MYERS SQUIBB

25MG 50MG 100MG 150MG 200MG

N020154 N020154 N020154 N020154 N020154

002 003 004 005 006

Oct Oct Oct Oct Oct

09, 09, 09, 09, 28,

1991 1991 1991 1991 1999

DIENESTROL
CREAM; VAGINAL DIENESTROL ORTHO MCNEIL PHARM DV SANOFI AVENTIS US ESTRAGUARD SOLVAY SUPPOSITORY; VAGINAL DV SANOFI AVENTIS US

0.01% 0.01% 0.01%

N006110 A083518 A084436

005 001 001

0.7MG

A083517

001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

DIETHYLCARBAMAZINE CITRATE
TABLET; ORAL HETRAZAN LEDERLE

6 - 110 (of 346)

50MG

N006459

001

DIETHYLPROPION HYDROCHLORIDE
TABLET; ORAL DIETHYLPROPION HYDROCHLORIDE SANDOZ 25MG TEVA 25MG TG UNITED LABS 25MG 25MG UCB INC 25MG WATSON LABS 25MG TENUATE SANOFI AVENTIS US 25MG TEPANIL 3M 25MG TABLET, EXTENDED RELEASE; ORAL TENUATE SANOFI AVENTIS US 75MG TEPANIL TEN-TAB 3M 75MG

A085916 A088642 A088267 A088268 A085544 A085741 N017668 N011673

001 001 001 001 001 001 001 001

Sep 20, 1984 Aug 25, 1983 Aug 25, 1983

N017669 N017956

001 001

DIETHYLSTILBESTROL
INJECTABLE; INJECTION STILBESTROL BRISTOL MYERS SQUIBB

0.2MG/ML 0.5MG/ML 1MG/ML 5MG/ML

N004056 N004056 N004056 N004056

003 004 005 006

SUPPOSITORY; VAGINAL DIETHYLSTILBESTROL LILLY STILBESTROL BRISTOL MYERS SQUIBB TABLET; ORAL DIETHYLSTILBESTROL LILLY

0.1MG 0.5MG 0.1MG 0.5MG

N004040 N004040 N004056 N004056

001 002 001 002

0.1MG 0.5MG 1MG 5MG 0.5MG 1MG 5MG

N004041 N004041 N004041 N004041 A083004 A083002 A083006 N004056 N004056 N004056 N004056 N004056

002 003 004 005 001 001 001 007 017 008 009 010

STILBESTROL TABLICAPS

0.1MG 0.25MG 0.5MG 1MG 5MG TABLET, DELAYED RELEASE; ORAL DIETHYLSTILBESTROL LILLY 0.1MG 0.25MG 0.5MG 1MG 5MG STILBESTROL TABLICAPS 0.5MG 1MG

STILBETIN BRISTOL MYERS SQUIBB

N004039 N004039 N004039 N004039 N004039 A083003 A083005

002 005 003 004 006 001 001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

DIETHYLSTILBESTROL
TABLET, DELAYED RELEASE; ORAL STILBESTROL TABLICAPS 5MG STILBETIN BRISTOL MYERS SQUIBB 0.1MG 0.5MG 1MG 5MG

6 - 111 (of 346)

A083007 N004056 N004056 N004056 N004056

001 011 012 013 014

DIETHYLSTILBESTROL DIPHOSPHATE
INJECTABLE; INJECTION STILPHOSTROL BAYER PHARMS TABLET; ORAL STILPHOSTROL BAYER PHARMS

250MG/5ML

N010010

001

50MG

N010010

002

DIFLORASONE DIACETATE
CREAM; TOPICAL FLORONE PHARMACIA AND UPJOHN FLORONE E PHARMACIA AND UPJOHN PSORCON SANOFI AVENTIS US OINTMENT; TOPICAL PSORCON PHARMACIA AND UPJOHN PSORCON E PHARMACIA AND UPJOHN

0.05% 0.05% 0.05%

N017741 N019259 N020205

001 001 001 Aug 28, 1985 Nov 20, 1992

0.05% 0.05%

N019260 N017994

001 001

Aug 28, 1985

DIFLUNISAL
TABLET; ORAL DIFLUNISAL PUREPAC PHARM ROXANE SANDOZ TEVA WATSON LABS DOLOBID MERCK

250MG 500MG 250MG 500MG 500MG 250MG 250MG 500MG 250MG 500MG

A074285 A074285 A073562 A073563 A074604 A073679 A074400 A074400 N018445 N018445

001 002 001 001 001 001 001 002 001 002

May May Nov Nov Jun Jul Jul Jul

07, 07, 27, 27, 10, 31, 17, 17,

1996 1996 1992 1992 1996 1992 1997 1997

Apr 19, 1982 Apr 19, 1982

DIGITOXIN
INJECTABLE; INJECTION CRYSTODIGIN LILLY

0.2MG/ML

A084100

005

DIGOXIN
CAPSULE; ORAL LANOXICAPS GLAXOSMITHKLINE LLC

0.05MG 0.1MG 0.15MG 0.2MG

N018118 N018118 N018118 N018118

002 003 004 001

Jul Jul Sep Jul

26, 26, 24, 26,

1982 1982 1984 1982

INJECTABLE; INJECTION DIGOXIN ABRAXIS PHARM HOSPIRA

0.25MG/ML 0.25MG/ML

A083217 A040206

001 001

Aug 28, 1998

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

DIGOXIN
INJECTABLE; INJECTION DIGOXIN WYETH AYERST DIGOXIN PEDIATRIC HOSPIRA TABLET; ORAL DIGOXIN ACTAVIS TOTOWA LANOXIN COVIS PHARMA

6 - 112 (of 346)

0.25MG/ML 0.1MG/ML

A084386 A040092

001 001 Apr 25, 1996

0.125MG 0.25MG 0.0625MG 0.1875MG 0.375MG 0.5MG

A040282 A040282 N020405 N020405 N020405 N020405

001 002 001 003 005 006

Dec 23, 1999 Dec 23, 1999 Sep Sep Sep Sep 30, 30, 30, 30, 1997 1997 1997 1997

DIHYDROERGOTAMINE MESYLATE; HEPARIN SODIUM; LIDOCAINE HYDROCHLORIDE

INJECTABLE; INJECTION EMBOLEX NOVARTIS

0.5MG/0.5ML;2,500 UNITS/0.5ML;5.33MG/0.5ML 0.5MG/0.7ML;5,000 UNITS/0.7ML;7.46MG/0.7ML

N018885 N018885

001 002

Nov 30, 1984 Nov 30, 1984

DILTIAZEM HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL CARDIZEM SR BIOVAIL 60MG 90MG 120MG 180MG DILTIAZEM HYDROCHLORIDE BIOVAIL 60MG 90MG 120MG 120MG 180MG 240MG 300MG 360MG 420MG TEVA 60MG 90MG 120MG INJECTABLE; INJECTION CARDIZEM BIOVAIL 100MG/VIAL BIOVAIL LABS INTL 5MG/ML 25MG/VIAL DILTIAZEM HYDROCHLORIDE HOSPIRA 5MG/ML 5MG/ML TABLET; ORAL DILTIAZEM HYDROCHLORIDE APOTHECON 30MG 60MG 90MG 120MG IVAX SUB TEVA PHARMS 30MG 60MG 90MG 120MG TEVA 30MG 60MG

N019471 N019471 N019471 N019471 A074845 A074845 A074845 N020939 N020939 N020939 N020939 N020939 N020939 A074079 A074079 A074079

001 002 003 004 001 002 003 001 002 003 004 005 006 001 002 003

Jan Jan Jan Jan Sep Sep Sep Jan Jan Jan Jan Sep Sep Nov Nov Nov

23, 23, 23, 23, 15, 15, 15, 28, 28, 28, 28, 14, 14, 30, 30, 30,

1989 1989 1989 1989 1999 1999 1999 2000 2000 2000 2000 2001 2001 1993 1993 1993

N020792 N020027 N020027 A075004 A075106

001 001 003 001 001

Sep 05, 1997 Oct 24, 1991 Aug 18, 1995 Feb 16, 2000 Apr 29, 1999

A074051 A074051 A074051 A074051 A074168 A074168 A074168 A074168 A074084 A074084

001 002 003 004 001 002 003 004 001 002

Mar Mar Mar Mar Mar Mar Mar Mar Feb Feb

31, 31, 31, 31, 03, 03, 03, 03, 25, 25,

1993 1993 1993 1993 1995 1995 1995 1995 1994 1994

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

DILTIAZEM HYDROCHLORIDE
TABLET; ORAL DILTIAZEM HYDROCHLORIDE TEVA PHARMS 30MG 60MG 90MG 120MG

6 - 113 (of 346)

A074067 A074067 A074067 A074067

001 002 003 004

Nov Nov Nov Nov

05, 05, 05, 05,

1992 1992 1992 1992

DILTIAZEM MALATE
TABLET, EXTENDED RELEASE; ORAL TIAMATE MERCK EQ 120MG HCL EQ 180MG HCL EQ 240MG HCL

N020506 N020506 N020506

001 002 003

Oct 04, 1996 Oct 04, 1996 Oct 04, 1996

DILTIAZEM MALATE; ENALAPRIL MALEATE

TABLET, EXTENDED RELEASE; ORAL TECZEM BIOVAIL EQ 180MG HCL;5MG

N020507

001

Oct 04, 1996

DIMENHYDRINATE
INJECTABLE; INJECTION DIMENHYDRINATE BAXTER HLTHCARE WATSON LABS WYETH AYERST LIQUID; ORAL DIMENHYDRINATE ALRA TABLET; ORAL DIMENHYDRINATE HEATHER NEXGEN PHARMA INC WATSON LABS

50MG/ML 50MG/ML 50MG/ML

A084767 A083531 A084316

001 001 001

12.5MG/4ML

A080715

001

50MG 50MG 50MG

A080841 A085985 A085166

001 001 001

DIMYRISTOYL LECITHIN; PERFLEXANE

INJECTABLE; INTRAVENOUS IMAGENT IMCOR PHARMS CO

0.92MG/VIAL;0.092MG/VIAL

N021191

001

May 31, 2002

DINOPROST TROMETHAMINE
INJECTABLE; INJECTION PROSTIN F2 ALPHA PHARMACIA AND UPJOHN

EQ 5MG BASE/ML

N017434

001

DIPHEMANIL METHYLSULFATE
TABLET; ORAL PRANTAL SCHERING

100MG

N008114

004

DIPHENHYDRAMINE HYDROCHLORIDE
CAPSULE; ORAL BENADRYL MCNEIL CONS

25MG 50MG DIPHENHYDRAMINE HYDROCHLORIDE ALRA 25MG 50MG ANABOLIC 50MG ELKINS SINN 25MG 50MG HALSEY 50MG HEATHER 25MG

N005845 N005845 A080519 A080519 A083275 A085701 A085701 A087914 A084524

007 001 004 003 001 001 002 001 001

Jun 04, 1984

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

DIPHENHYDRAMINE HYDROCHLORIDE
CAPSULE; ORAL DIPHENHYDRAMINE HYDROCHLORIDE HEATHER 50MG IMPAX LABS 25MG 50MG IVAX SUB TEVA PHARMS 25MG 50MG LANNETT 25MG 50MG LEDERLE 25MG 50MG LNK 25MG 50MG MK LABS 25MG 50MG MUTUAL PHARM 25MG 25MG 50MG NEWTRON PHARMS 25MG 50MG NEXGEN PHARMA INC 25MG PERRIGO 25MG 50MG PIONEER PHARMS 25MG 50MG PUREPAC PHARM 25MG 50MG PVT FORM 25MG 50MG ROXANE 50MG SANDOZ 25MG 25MG 50MG 50MG SUPERPHARM 25MG 50MG TEVA 25MG 50MG VALEANT PHARM INTL 25MG 50MG VANGARD 25MG 50MG WATSON LABS 25MG 25MG 25MG 50MG 50MG 50MG WEST WARD 50MG WHITEWORTH TOWN PLSN 25MG 50MG ELIXIR; ORAL BELIX HALSEY 12.5MG/5ML BENADRYL MCNEIL CONS 12.5MG/5ML DIBENIL CENCI 12.5MG/5ML DIPHEN USL PHARMA 12.5MG/5ML DIPHENHYDRAMINE HYDROCHLORIDE BUNDY 12.5MG/5ML

6 - 114 (of 346)

A083953 A080807 A080807 A080762 A080762 A080868 A080868 A086874 A086875 A087977 A087978 A083087 A083087 A084506 A089488 A089489 A086543 A086544 A083634 A083061 A083061 A089101 A088880 A085156 A085150 A083027 A083027 A080635 A080832 A080845 A080832 A080845 A089040 A089041 A085874 A085874 A080596 A080592 A088034 A087630 A080728 A083797 A085138 A080727 A083797 A085083 A083567 A083441 A080800

001 001 002 001 002 001 002 001 001 001 001 001 002 001 001 001 001 001 001 001 002 001 001 001 001 001 002 001 001 002 002 001 001 001 001 002 001 001 001 001 001 001 001 001 002 001 001 001 001

Jan 27, 1983 Jan 27, 1983

Jan 02, 1987 Jan 02, 1987

Dec 20, 1985 Dec 20, 1985

May 15, 1985 May 15, 1985

Oct 27, 1982

A086586 N005845 A088304 A084640 A083674

001 004 001 001 001

Oct 03, 1983

Dec 16, 1983

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

DIPHENHYDRAMINE HYDROCHLORIDE
ELIXIR; ORAL DIPHENHYDRAMINE HYDROCHLORIDE CENCI 12.5MG/5ML KV PHARM 12.5MG/5ML LANNETT 12.5MG/5ML LEDERLE 12.5MG/5ML MK LABS 12.5MG/5ML NASKA 12.5MG/5ML PERRIGO 12.5MG/5ML PUREPAC PHARM 12.5MG/5ML PVT FORM 12.5MG/5ML ROXANE 12.5MG/5ML HYDRAMINE ALPHARMA US PHARMS 12.5MG/5ML INJECTABLE; INJECTION BENADRYL MCNEIL CONS 10MG/ML DIPHENHYDRAMINE HYDROCHLORIDE BAXTER HLTHCARE 50MG/ML BEL MAR 10MG/ML LYPHOMED 10MG/ML WATSON LABS 10MG/ML WYETH AYERST 50MG/ML DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE ABRAXIS PHARM 50MG/ML SYRUP; ORAL ANTITUSSIVE PERRIGO 12.5MG/5ML BELDIN HALSEY 12.5MG/5ML BENYLIN PARKE DAVIS 12.5MG/5ML DIPHEN MORTON GROVE 12.5MG/5ML DIPHENHYDRAMINE HYDROCHLORIDE ALPHARMA US PHARMS 12.5MG/5ML CUMBERLAND SWAN 12.5MG/5ML HI TECH PHARMA 12.5MG/5ML HYDRAMINE ALPHARMA US PHARMS 12.5MG/5ML SILPHEN SILARX 12.5MG/5ML VICKS FORMULA 44 WARNER CHILCOTT 12.5MG/5ML

6 - 115 (of 346)

A087941 A085621 A080939 A086937 A083088 A088680 A083063 A083237 A085287 A080643 A080763

001 001 002 001 002 001 001 001 001 001 002

Dec 17, 1982

May 31, 1985 Jan 25, 1982

N006146 A083183 A080822 A087066 A083533 A080577 A080586

001 001 001 001 001 001 002

A071292 A089179 N006514 A070118 A070497 A073611 A072416 A070205 A072646 A070524

001 001 004 001 001 001 001 001 001 001

Apr 10, 1987 Jun 05, 1986

Oct 01, 1985 Apr 25, 1989 Aug 20, 1992 Sep 28, 1990 Jan 28, 1986 Feb 27, 1992 Jan 14, 1987

DIPHENHYDRAMINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

SOLUTION; ORAL BENYLIN PARKE DAVIS

12.5MG/5ML;30MG/5ML

N019014

001

Jun 11, 1985

DIPHENIDOL HYDROCHLORIDE
TABLET; ORAL VONTROL GLAXOSMITHKLINE

EQ 25MG BASE

N016033

001

DIPHENYLPYRALINE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL HISPRIL GLAXOSMITHKLINE 5MG

N011945

001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

DIPIVEFRIN HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC DIPIVEFRIN HYDROCHLORIDE BAUSCH AND LOMB 0.1%

6 - 116 (of 346)

A074188

001

May 19, 1995

DIPYRIDAMOLE
INJECTABLE; INJECTION DIPYRIDAMOLE HOSPIRA IV PERSANTINE BOEHRINGER INGELHEIM TABLET; ORAL DIPYRIDAMOLE PUREPAC PHARM SANDOZ

5MG/ML 5MG/ML

A074601 N019817

001 001

Dec 19, 1997 Dec 13, 1990

50MG 75MG 25MG 50MG 75MG

A089426 A089427 A086944 A087562 A087561

001 001 002 001 001

Jul Jul Apr Feb Feb

12, 12, 16, 25, 25,

1990 1990 1991 1992 1992

DIRITHROMYCIN
TABLET, DELAYED RELEASE; ORAL DYNABAC LILLY RES LABS 250MG

N050678

001

Jun 19, 1995

DISOPYRAMIDE PHOSPHATE
CAPSULE; ORAL DISOPYRAMIDE PHOSPHATE INTERPHARM IVAX SUB TEVA PHARMS MUTUAL PHARM MYLAN SANDOZ SUPERPHARM WATSON LABS

EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ

100MG 150MG 100MG 150MG 100MG 150MG 100MG 150MG 100MG 150MG 100MG 150MG 100MG 150MG

BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE

A071190 A071191 A070186 A070187 A070351 A070352 A070138 A070139 A070470 A070471 A070940 A070941 A070240 A070241

001 001 001 001 001 001 001 001 001 001 001 001 001 001

Jan Jan Nov Nov Dec Dec Jun Jun Dec Dec Feb Feb Feb Feb

15, 15, 18, 18, 17, 17, 14, 14, 10, 10, 09, 09, 02, 02,

1987 1987 1985 1985 1985 1985 1985 1985 1985 1985 1987 1987 1986 1986

DISULFIRAM
TABLET; ORAL ANTABUSE TEVA WOMENS DISULFIRAM PAR PHARM WATSON LABS

250MG 500MG 250MG 500MG 250MG 250MG 500MG 500MG

N007883 N007883 A088792 A088793 A086889 A087973 A086890 A087974

003 002 001 001 001 001 001 001 Aug 14, 1984 Aug 14, 1984 Aug 05, 1983 Aug 05, 1983

DIVALPROEX SODIUM
TABLET, DELAYED RELEASE; ORAL DEPAKOTE CP ABBOTT EQ 250MG BASE EQ 500MG BASE

N019794 N019794

001 002

Jul 11, 1990 Jul 11, 1990

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

DOBUTAMINE HYDROCHLORIDE
INJECTABLE; INJECTION DOBUTAMINE HYDROCHLORIDE ASTRAZENECA EQ BAXTER HLTHCARE EQ HOSPIRA EQ LUITPOLD EQ MARSAM PHARMS LLC EQ EQ TEVA PARENTERAL EQ DOBUTREX LILLY EQ

6 - 117 (of 346)

12.5MG 12.5MG 1.25GM 12.5MG 12.5MG 12.5MG 12.5MG

BASE/ML BASE/ML BASE/100ML BASE/ML BASE/ML BASE/ML BASE/ML

A074098 A074381 A074634 A074545 A074279 A074995 A074206 N017820

001 001 001 001 001 001 001 002

Feb Sep Sep Jun Feb Mar Oct

21, 26, 27, 25, 18, 31, 19,

1995 1996 1996 1998 1998 1998 1993

12.5MG BASE/ML

DOCETAXEL
INJECTABLE; INJECTION TAXOTERE SANOFI AVENTIS US

40MG/ML

N020449

001

May 14, 1996

DONEPEZIL HYDROCHLORIDE
SOLUTION; ORAL ARICEPT EISAI INC 5MG/5ML TABLET, ORALLY DISINTEGRATING; ORAL DONEPEZIL HYDROCHLORIDE MUTUAL PHARM 5MG 10MG

N021719

001

Oct 18, 2004

A077975 A077975

002 001

Dec 11, 2009 Dec 11, 2009

DOPAMINE HYDROCHLORIDE
INJECTABLE; INJECTION DOPAMINE HYDROCHLORIDE ABBOTT

40MG/ML 80MG/ML ABRAXIS PHARM 40MG/ML 40MG/ML 80MG/ML 80MG/ML 160MG/ML ASTRAZENECA 40MG/ML 40MG/ML 80MG/ML 80MG/ML 80MG/ML 160MG/ML 160MG/ML 160MG/ML BAXTER HLTHCARE 40MG/ML 80MG/ML HOSPIRA 40MG/ML INTL MEDICATION 40MG/ML LYPHOMED 40MG/ML SMITH AND NEPHEW 40MG/ML 40MG/ML 80MG/ML TEVA PARENTERAL 40MG/ML 80MG/ML WARNER CHILCOTT 40MG/ML 40MG/ML 80MG/ML DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% HOSPIRA 1.6MG/ML INTROPIN HOSPIRA 40MG/ML 80MG/ML

A070656 A070657 A070012 A070058 A070013 A070059 A070364 A070087 N018656 A070089 A070090 A070091 A070092 A070093 A070094 N018398 N018398 A074403 N018014 N018549 A070011 A070046 A070047 A072999 A073000 A070558 N018138 A070559 N020542 N017395 N017395

001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 002 001 001 001 001 001 001 001 001 001 001 001 001 001 002

Jan Jan Jun Mar Jun Mar Dec Oct Jun Oct Oct Oct Oct Oct Oct

24, 24, 12, 20, 12, 20, 04, 23, 28, 23, 23, 23, 23, 23, 23,

1989 1989 1985 1985 1985 1985 1985 1985 1983 1985 1985 1985 1985 1985 1985

Mar 22, 1982 May 23, 1996 Mar Aug Aug Aug Oct Oct Sep 11, 29, 29, 29, 23, 23, 20, 1983 1985 1985 1985 1991 1991 1985

Sep 20, 1985 Aug 30, 1995

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

DOPAMINE HYDROCHLORIDE
INJECTABLE; INJECTION INTROPIN HOSPIRA

6 - 118 (of 346)

160MG/ML

N017395

003

DOXACURIUM CHLORIDE
INJECTABLE; INJECTION NUROMAX ABBOTT

EQ 1MG BASE/ML

N019946

001

Mar 07, 1991

DOXAZOSIN MESYLATE
TABLET; ORAL DOXAZOSIN MESYLATE ACTAVIS ELIZABETH

GENPHARM

IVAX SUB TEVA PHARMS

SANDOZ

TEVA

EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ

1MG 2MG 4MG 8MG 1MG 2MG 4MG 8MG 1MG 2MG 4MG 8MG 1MG 1MG 2MG 2MG 4MG 4MG 8MG 8MG 1MG 2MG 4MG 8MG

BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE

A075574 A075574 A075574 A075574 A075466 A075466 A075466 A075466 A075453 A075453 A075453 A075453 A075432 A075646 A075432 A075646 A075432 A075646 A075432 A075646 A075353 A075353 A075353 A075353

001 002 003 004 001 002 003 004 001 002 003 004 001 001 002 002 003 003 004 004 001 002 003 004

Oct Oct Oct Oct Oct Oct Oct Oct Oct Oct Oct Oct Oct Oct Oct Oct Oct Oct Oct Oct Jan Jan Jan Jan

18, 18, 18, 18, 18, 18, 18, 18, 18, 18, 18, 18, 18, 18, 18, 18, 18, 18, 18, 18, 12, 12, 12, 12,

2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2001 2001 2001 2001

DOXEPIN HYDROCHLORIDE
CAPSULE; ORAL DOXEPIN HYDROCHLORIDE CLONMEL HLTHCARE

MUTUAL PHARM

NEW RIVER

PUREPAC PHARM

EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ

10MG BASE 25MG BASE 50MG BASE 75MG BASE 100MG BASE 150MG BASE 25MG BASE 50MG BASE 75MG BASE 100MG BASE 10MG BASE 25MG BASE 50MG BASE 75MG BASE 100MG BASE 150MG BASE 10MG BASE 25MG BASE 50MG BASE 75MG BASE 100MG BASE 150MG BASE

A071685 A071686 A071673 A071674 A071675 A071676 A071502 A071653 A071654 A071521 N016987 N016987 N016987 N016987 N016987 N016987 A073054 A072109 A073055 A072386 A072110 A072387

001 001 001 001 001 001 001 001 001 001 001 002 003 006 004 007 001 001 001 001 001 001

Jan Jan Jan Jan Jan Jan Feb Feb Feb Feb

05, 05, 05, 05, 05, 05, 18, 18, 18, 18,

1988 1988 1988 1988 1988 1988 1988 1988 1988 1988

Apr Dec Dec Dec Sep Sep Sep

13, 28, 28, 28, 08, 08, 08,

1987 1990 1990 1990 1988 1988 1988

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

DOXEPIN HYDROCHLORIDE
CAPSULE; ORAL DOXEPIN HYDROCHLORIDE QUANTUM PHARMICS

6 - 119 (of 346)

SANDOZ

WATSON LABS

EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ

10MG BASE 25MG BASE 50MG BASE 75MG BASE 100MG BASE 150MG BASE 10MG BASE 25MG BASE 50MG BASE 75MG BASE 100MG BASE 10MG BASE 10MG BASE 25MG BASE 25MG BASE 50MG BASE 50MG BASE 75MG BASE 100MG BASE 150MG BASE 10MG BASE 25MG BASE 50MG BASE 75MG BASE 100MG BASE 150MG BASE

A070972 A070973 A070931 A070932 A072375 A072376 A071487 A070827 A070828 A070825 A071562 A070952 A072985 A070953 A072986 A070954 A072987 A071763 A070955 A071764 N016798 N016798 N016798 N016798 N016798 N016798

001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 003 001 002 006 005 007

Sep Sep Sep Sep Mar Mar Mar May May May Mar Mar Mar May Mar May Mar Feb May Feb

29, 29, 29, 29, 15, 15, 02, 15, 15, 15, 02, 04, 29, 15, 29, 15, 29, 09, 15, 09,

1987 1987 1987 1987 1989 1989 1987 1986 1986 1986 1987 1987 1991 1986 1991 1986 1991 1988 1986 1988

SINEQUAN PFIZER

CONCENTRATE; ORAL SINEQUAN PFIZER

EQ 10MG BASE/ML

N017516

001

DOXORUBICIN HYDROCHLORIDE
INJECTABLE; INJECTION ADRIAMYCIN PFS PHARMACIA AND UPJOHN

2MG/ML 2MG/ML 200MG/100ML 200MG/100ML 10MG/VIAL 20MG/VIAL 50MG/VIAL 150MG/VIAL 10MG/VIAL 50MG/VIAL 100MG/VIAL

A063165 N050629 A063165 N050629 N050467 N050467 N050467 N050467 A062926 A062926 A062926

001 001 002 002 001 003 002 004 001 002 003

Jan Dec Jan May

30, 23, 30, 03,

1991 1987 1991 1988

ADRIAMYCIN RDF PHARMACIA AND UPJOHN

May 20, 1985 Jul 22, 1987 Apr 13, 1989 Apr 13, 1989 Apr 13, 1989

RUBEX BRISTOL MYERS SQUIBB

DOXYCYCLINE
CAPSULE; ORAL DOXYCYCLINE PAR PHARM FOR SUSPENSION; ORAL DOXYCHEL RACHELLE TABLET; ORAL DOXYCYCLINE MUTUAL PHARM

EQ 75MG BASE

A065055

004

Apr 18, 2005

EQ 25MG BASE/5ML

A061720

001

EQ 50MG BASE EQ 75MG BASE EQ 100MG BASE

A065471 A065471 A065471

001 002 003

Apr 17, 2009 Apr 17, 2009 Apr 17, 2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

DOXYCYCLINE HYCLATE
CAPSULE; ORAL DOXYCYCLINE HYCLATE HALSEY HEATHER INTERPHARM MUTUAL PHARM MYLAN PAR PHARM PVT FORM RANBAXY SUPERPHARM WARNER CHILCOTT WATSON LABS

6 - 120 (of 346)

EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ

50MG BASE 100MG BASE 50MG BASE 100MG BASE 50MG BASE 100MG BASE 50MG BASE 100MG BASE 50MG BASE 100MG BASE 50MG BASE 100MG BASE 50MG BASE 100MG BASE 50MG BASE 100MG BASE 50MG BASE 100MG BASE 50MG BASE 100MG BASE 50MG BASE 50MG BASE 100MG BASE 100MG BASE

A062119 A062119 A062463 A062463 A062763 A062763 A062418 A062418 A062337 A062337 A062434 A062442 A062631 A062631 A062479 A062479 A062469 A062469 A062594 A062594 A061717 A062142 A061717 A062142 A062497 A062497 N050744

002 001 001 002 001 002 001 002 001 002 001 001 001 002 001 002 001 002 001 002 001 001 002 002 001 002 001

May May Dec Dec Sep Sep Jan Jan Mar Mar Oct Dec Jul Jul Dec Dec Oct Oct Dec Dec

24, 24, 07, 07, 02, 02, 28, 28, 29, 29, 19, 22, 24, 24, 23, 23, 31, 31, 05, 05,

1985 1985 1983 1983 1988 1988 1983 1983 1982 1982 1984 1983 1986 1986 1983 1983 1984 1984 1985 1985

DOXY-LEMMON TEVA

EQ 50MG BASE EQ 100MG BASE

Aug 23, 1984 Jun 15, 1984 Sep 30, 1998

PERIOSTAT COLLAGENEX EQ 20MG BASE CAPSULE, COATED PELLETS; ORAL DOXYCYCLINE HYCLATE PLIVA EQ 100MG BASE CAPSULE, DELAYED RELEASE; ORAL DORYX MAYNE PHARMA INTL EQ 75MG BASE EQ 100MG BASE WARNER CHILCOTT EQ 100MG BASE INJECTABLE; INJECTION DOXYCHEL HYCLATE RACHELLE EQ 100MG BASE/VIAL DOXYCYCLINE BAXTER HLTHCARE EQ 100MG BASE/VIAL EQ 200MG BASE/VIAL BEDFORD EQ 200MG BASE/VIAL DOXYCYCLINE HYCLATE BAXTER HLTHCARE EQ 100MG BASE/VIAL EQ 200MG BASE/VIAL VIBRAMYCIN PFIZER EQ 100MG BASE/VIAL EQ 200MG BASE/VIAL TABLET; ORAL DOXYCYCLINE HYCLATE HEATHER EQ 100MG BASE INTERPHARM EQ 100MG BASE LARKEN LABS EQ 20MG BASE MUTUAL PHARM EQ 100MG BASE MYLAN EQ 100MG BASE SUPERPHARM EQ 100MG BASE TRUXTON INC EQ 50MG BASE EQ 100MG BASE WARNER CHILCOTT EQ 100MG BASE

A063187

001

Jun 30, 1992

N050582 N050582 A062653

002 001 001

Aug 13, 2001 Jul 22, 1985 Oct 30, 1985

A061953 A062450 A062450 A062569 A062992 A062992 N050442 N050442

001 001 002 002 001 002 002 001 Oct 27, 1983 Oct 27, 1983 Mar 09, 1988 Feb 16, 1989 Feb 16, 1989

A062462 A062764 A065287 A062391 A062432 A062494 A062269 A062269 A062593

001 001 001 001 001 001 003 002 001

May Sep Feb Sep Feb Feb

11, 02, 28, 30, 15, 20,

1983 1988 2006 1982 1983 1985

Nov 08, 1982 Aug 28, 1985

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

DOXYCYCLINE HYCLATE
TABLET; ORAL DOXYCYCLINE HYCLATE WATSON LABS DOXY-LEMMON TEVA VIBRA-TABS PFIZER

6 - 121 (of 346)

EQ 50MG BASE EQ 100MG BASE EQ 100MG BASE EQ 100MG BASE

A062392 A062392 A062581 N050533

001 002 001 001

Mar 31, 1983 Mar 31, 1983 Mar 15, 1985

DOXYLAMINE SUCCINATE
CAPSULE; ORAL UNISOM PFIZER TABLET; ORAL DECAPRYN SANOFI AVENTIS US DOXYLAMINE SUCCINATE COPLEY PHARM QUANTUM PHARMICS DOXY-SLEEP-AID PAR PHARM

25MG

N019440

001

Feb 05, 1986

12.5MG 25MG 25MG 25MG 25MG

N006412 N006412 A088900 A088603 A070156

015 014 002 001 001 Feb 12, 1988 Aug 07, 1984 Jul 02, 1987

DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE

TABLET, EXTENDED RELEASE; ORAL BENDECTIN SANOFI AVENTIS US 10MG;10MG

N010598

002

DROMOSTANOLONE PROPIONATE
INJECTABLE; INJECTION DROLBAN LILLY

50MG/ML

N012936

001

DROPERIDOL
INJECTABLE; INJECTION DROPERIDOL ABRAXIS PHARM ASTRAZENECA

HOSPIRA LUITPOLD SMITH AND NEPHEW SOLOPAK WATSON LABS

2.5MG/ML 2.5MG/ML 2.5MG/ML 2.5MG/ML 2.5MG/ML 2.5MG/ML 2.5MG/ML 2.5MG/ML 2.5MG/ML 2.5MG/ML 2.5MG/ML 2.5MG/ML 2.5MG/ML 2.5MG/ML 2.5MG/ML

A070992 A070993 A072018 A072019 A072020 A072021 A071645 A072272 A072335 A071750 A071754 A071755 A073520 A073521 A073523

001 001 001 001 001 001 001 001 001 001 001 001 001 001 001

Nov Nov Oct Oct Oct Oct Apr Aug Oct Sep Sep Sep Nov Nov Nov

17, 17, 20, 19, 19, 19, 07, 31, 24, 06, 06, 06, 27, 27, 27,

1986 1986 1988 1988 1988 1988 1988 1995 1988 1988 1988 1988 1991 1991 1991

DROPERIDOL; FENTANYL CITRATE

INJECTABLE; INJECTION FENTANYL CITRATE AND DROPERIDOL ASTRAZENECA 2.5MG/ML;EQ 2.5MG/ML;EQ 2.5MG/ML;EQ HOSPIRA 2.5MG/ML;EQ INNOVAR AKORN MFG 2.5MG/ML;EQ

0.05MG 0.05MG 0.05MG 0.05MG

BASE/ML BASE/ML BASE/ML BASE/ML

A072026 A072027 A072028 A071982 N016049

001 001 001 001 001

Apr Apr Apr May

13, 13, 13, 04,

1989 1989 1989 1988

0.05MG BASE/ML

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

DYCLONINE HYDROCHLORIDE
SOLUTION; TOPICAL DYCLONE ASTRAZENECA

6 - 122 (of 346)

0.5% 1%

N009925 N009925

002 001

DYDROGESTERONE
TABLET; ORAL GYNOREST SOLVAY

5MG 10MG

N017388 N017388

001 002

DYPHYLLINE
ELIXIR; ORAL NEOTHYLLINE TEVA INJECTABLE; INJECTION NEOTHYLLINE TEVA TABLET; ORAL DILOR SAVAGE LABS DILOR-400 SAVAGE LABS NEOTHYLLINE TEVA

160MG/15ML

N007794

003

250MG/ML

N009088

001

200MG 400MG 200MG 400MG

A084514 A084751 N007794 N007794

001 001 001 002

ECHOTHIOPHATE IODIDE
FOR SOLUTION; OPHTHALMIC PHOSPHOLINE IODIDE WYETH PHARMS INC

0.03% 0.06% 0.25%

N011963 N011963 N011963

002 004 003

ECONAZOLE NITRATE
CREAM; TOPICAL SPECTAZOLE ORTHO JANSSEN

1%

N018751

001

Dec 23, 1982

EDETATE CALCIUM DISODIUM

TABLET; ORAL CALCIUM DISODIUM VERSENATE MEDICIS 500MG

N008922

002

EDETATE DISODIUM
INJECTABLE; INJECTION DISODIUM EDETATE WATSON LABS EDETATE DISODIUM WATSON LABS SODIUM VERSENATE 3M

150MG/ML 150MG/ML 200MG/ML

A084356 A080391 N010573

001 001 001

EDROPHONIUM CHLORIDE
INJECTABLE; INJECTION EDROPHONIUM CHLORIDE HOSPIRA 10MG/ML WATSON LABS 10MG/ML EDROPHONIUM CHLORIDE PRESERVATIVE FREE WATSON LABS 10MG/ML REVERSOL ORGANON USA INC 10MG/ML

A040131 A040044 A040043 A089624

001 001 001 001

Feb 24, 1998 Mar 20, 1996 Mar 20, 1996 May 13, 1988

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

EFAVIRENZ
CAPSULE; ORAL SUSTIVA BRISTOL MYERS SQUIBB TABLET; ORAL SUSTIVA BRISTOL MYERS SQUIBB

6 - 123 (of 346)

100MG

N020972

002

Sep 17, 1998

300MG

N021360

001

Feb 01, 2002

EFLORNITHINE HYDROCHLORIDE
INJECTABLE; INJECTION ORNIDYL SANOFI AVENTIS US

200MG/ML

N019879

002

Nov 28, 1990

ENALAPRIL MALEATE
TABLET; ORAL ENALAPRIL MALEATE APOTHECON

IVAX SUB TEVA PHARMS

KRKA DD NOVO MESTO

RANBAXY

SANDOZ

2.5MG 5MG 10MG 20MG 2.5MG 5MG 10MG 20MG 2.5MG 5MG 10MG 20MG 2.5MG 5MG 10MG 20MG 2.5MG 5MG 10MG 20MG

A075583 A075583 A075583 A075583 A075482 A075482 A075482 A075482 A075370 A075370 A075369 A075369 A075556 A075556 A075556 A075556 A075048 A075048 A075048 A075048

001 002 003 004 001 002 003 004 001 002 001 002 001 002 003 004 001 002 003 004

Aug Aug Aug Aug Aug Aug Aug Aug Aug Aug Aug Aug Aug Aug Aug Aug Aug Aug Aug Aug

22, 22, 22, 22, 22, 22, 22, 22, 22, 22, 22, 22, 22, 22, 22, 22, 22, 22, 22, 22,

2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000

ENALAPRIL MALEATE; FELODIPINE

TABLET, EXTENDED RELEASE; ORAL LEXXEL ASTRAZENECA 5MG;2.5MG 5MG;5MG

N020668 N020668

002 001

Oct 28, 1998 Dec 27, 1996

ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE

TABLET; ORAL ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE IVAX SUB TEVA PHARMS 5MG;12.5MG 10MG;25MG

A075736 A075736

001 002

Mar 25, 2003 Mar 25, 2003

ENALAPRILAT
INJECTABLE; INJECTION ENALAPRILAT HOSPIRA VASOTEC BIOVAIL LABS INTL

1.25MG/ML 1.25MG/ML 1.25MG/ML

A075456 A075571 N019309

001 001 001

Aug 22, 2000 Aug 22, 2000 Feb 09, 1988

ENFLURANE
LIQUID; INHALATION ENFLURANE ABBOTT

99.9%

A070803

001

Sep 08, 1987

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

ENOXACIN
TABLET; ORAL PENETREX SANOFI AVENTIS US

6 - 124 (of 346)

200MG 400MG

N019616 N019616

004 005

Dec 31, 1991 Dec 31, 1991

ENOXAPARIN SODIUM
INJECTABLE; SUBCUTANEOUS LOVENOX (PRESERVATIVE FREE) SANOFI AVENTIS US 90MG/0.6ML (150MG/ML)

N020164

006

Jun 02, 2000

EPINEPHRINE
AEROSOL, METERED; INHALATION BRONKAID MIST STERLING 0.25MG/INH PRIMATENE MIST WYETH CONS 0.2MG/INH INJECTABLE; INJECTION SUS-PHRINE SULFITE-FREE FOREST LABS 1.5MG/AMP 5MG/ML INJECTABLE; INTRAMUSCULAR EPI E Z PEN JR MERIDIAN MEDCL TECHN 0.15MG/DELIVERY EPIPEN E Z PEN MERIDIAN MEDCL TECHN 0.3MG/DELIVERY

N016803 N016126

001 001

N007942 N007942

003 001

Feb 05, 1999

N019430 N019430

004 003

Aug 03, 1995 Aug 03, 1995

EPINEPHRINE BITARTRATE
AEROSOL, METERED; INHALATION BRONITIN MIST WYETH CONS 0.3MG/INH MEDIHALER-EPI 3M 0.3MG/INH

N016126 N010374

002 003

EPINEPHRINE BITARTRATE; ETIDOCAINE HYDROCHLORIDE

INJECTABLE; INJECTION DURANEST ASTRAZENECA DENTSPLY PHARM

0.005MG/ML;1% 0.005MG/ML;1.5% 0.005MG/ML;1.5%

N017751 N017751 N021384

006 007 001

EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE

INJECTABLE; INJECTION CITANEST FORTE ASTRAZENECA

0.005MG/ML;4%

N014763

008

EPINEPHRINE; ETIDOCAINE HYDROCHLORIDE

INJECTABLE; INJECTION DURANEST ASTRAZENECA

0.005MG/ML;0.5%

N017751

004

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

INJECTABLE; INJECTION ALPHACAINE HYDROCHLORIDE W/ EPINEPHRINE CARLISLE 0.01MG/ML;2% 0.02MG/ML;2% LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE ELKINS SINN 0.01MG/ML;1% 0.01MG/ML;2% GRAHAM CHEM 0.01MG/ML;2% 0.02MG/ML;2% HOSPIRA 0.005MG/ML;1% 0.005MG/ML;1.5%

A084720 A084732 A080406 A080406 A080504 A080504 A089649 A089650

001 001 001 002 004 005 001 001

Oct Oct Jun Jun

19, 19, 21, 21,

1983 1983 1988 1988

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE
INJECTABLE; INJECTION LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE ABBOTT 0.01MG/ML;1% BEL MAR 0.01MG/ML;1% 0.01MG/ML;2% DELL LABS 0.01MG/ML;1% 0.01MG/ML;2% INTL MEDICATION 0.01MG/ML;1% WATSON LABS 0.01MG/ML;1% 0.01MG/ML;1% 0.01MG/ML;2% LIDOCATON PHARMATON 0.01MG/ML;2% 0.02MG/ML;2% XYLOCAINE W/ EPINEPHRINE APP PHARMS 0.01MG/ML;2% ASTRAZENECA 0.005MG/ML;1% 0.005MG/ML;1.5% 0.005MG/ML;2% PATCH; IONTOPHORESIS, TOPICAL LIDOSITE TOPICAL SYSTEM KIT VYTERIS 1.05MG/PATCH;100MG/PATCH SOLUTION; IONTOPHORESIS IONTOCAINE IOMED 0.01MG/ML;2% SOLUTION; IONTOPHORESIS, TOPICAL LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE EMPI 0.01MG/ML;2%

6 - 125 (of 346)

A083154 A080820 A080757 A083389 A083390 A086402 A080377 A085463 A080377 A084729 A084728 N006488 N010418 N010418 N010418

001 001 001 001 001 001 003 001 004 001 001 003 006 010 008 Aug 17, 1983 Aug 17, 1983

N021504

001

May 06, 2004

N020530

001

Dec 21, 1995

N021486

001

Oct 26, 2004

EPINEPHRINE; PROCAINE HYDROCHLORIDE

INJECTABLE; INJECTION PROCAINE HYDROCHLORIDE W/ EPINEPHRINE BEL MAR 0.02MG/ML;1% 0.02MG/ML;2%

A080758 A080759

001 001

EPIRUBICIN HYDROCHLORIDE
INJECTABLE; IV (INFUSION) EPIRUBICIN HYDROCHLORIDE HOSPIRA 200MG/VIAL

N050807

002

Sep 15, 2006

EPLERENONE
TABLET; ORAL INSPRA GD SEARLE LLC

100MG

N021437

003

Sep 27, 2002

EPROSARTAN MESYLATE
TABLET; ORAL TEVETEN ABBOTT

EQ 300MG BASE

N020738

004

Dec 22, 1997

ERGOCALCIFEROL
CAPSULE; ORAL DELTALIN LILLY VITAMIN D CHASE CHEM EVERYLIFE IMPAX LABS LANNETT VITARINE WEST WARD

50,000 IU 50,000 50,000 50,000 50,000 50,000 50,000 IU IU IU IU IU IU

A080884 A080747 A080956 A080951 A080825 A084053 A083102

001 001 001 001 001 001 001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

ERGOLOID MESYLATES
CAPSULE; ORAL HYDERGINE LC NOVARTIS SOLUTION; ORAL HYDERGINE NOVARTIS TABLET; ORAL ERGOLOID MESYLATES MUTUAL PHARM WATSON LABS GERIMAL WATSON LABS HYDERGINE NOVARTIS TABLET; SUBLINGUAL ALKERGOT SANDOZ CIRCANOL 3M DEAPRIL-ST BRISTOL MYERS SQUIBB ERGOLOID MESYLATES KV PHARM

6 - 126 (of 346)

1MG

N018706

001

Jan 18, 1983

1MG/ML

N018418

001

1MG 1MG 1MG 1MG 0.5MG

A088891 A086433 A087244 A088207 N017993

001 001 001 001 003

Nov 01, 1985 May 27, 1982 Aug 16, 1982 Mar 22, 1984

0.5MG 1MG 0.5MG 1MG 1MG 0.5MG 0.5MG 1MG 1MG 0.5MG 1MG 0.5MG 1MG 0.5MG 1MG 0.5MG 1MG 0.5MG 1MG 1MG 0.5MG 1MG

A085153 A087417 A084868 A085809 A085020 A085899 A086265 A085900 A086264 A086984 A086985 A087407 A087552 A089233 A089234 A088013 A088014 A084930 A085177 A087183 A086189 A086188 N009087 N009087 A087186 A087185

001 001 001 001 002 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 002 001 001 001

LEDERLE MUTUAL PHARM SUPERPHARM VANGARD WATSON LABS

Sep Sep Sep Sep

23, 23, 20, 20,

1986 1986 1982 1982

GERIMAL WATSON LABS HYDERGINE NOVARTIS

0.5MG 1MG HYDROGENATED ERGOT ALKALOIDS IVAX PHARMS 0.5MG 1MG

ERGOTAMINE TARTRATE
AEROSOL, METERED; INHALATION MEDIHALER ERGOTAMINE 3M 0.36MG/INH TABLET; SUBLINGUAL ERGOSTAT PARKE DAVIS 2MG WIGRETTES ORGANON USA INC 2MG

N012102

001

A088337 A086750

001 001

Jun 08, 1984 Jul 29, 1982

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

ERYTHROMYCIN
CAPSULE, DELAYED REL PELLETS; ORAL ERYC PARKE DAVIS 250MG 250MG ERYC 125 PARKE DAVIS 125MG ERYC SPRINKLES HOSPIRA 125MG ERYTHROMYCIN BARR 250MG GEL; TOPICAL EMGEL ALTANA 2% LOTION; TOPICAL E-SOLVE 2 SYOSSET 2% OINTMENT; OPHTHALMIC ERYTHROMYCIN PHARMADERM 5MG/GM PHARMAFAIR 5MG/GM ILOTYCIN DISTA 0.5% POWDER; FOR RX COMPOUNDING ERYTHROMYCIN PADDOCK LLC 100% SOLUTION; TOPICAL A/T/S TARO PHARMS NORTH 2% C-SOLVE-2 BIOGLAN PHARMA 2% ERYDERM ARBOR PHARMS INC 2% ERYMAX MERZ PHARMS 2% ERYTHROMYCIN ALPHARMA US PHARMS 1.5% 2% 2% 2% 2% BAUSCH AND LOMB 2% COREPHARMA 2% LILLY 2% PHARMAFAIR 1.5% 2% SANSAC DOW PHARM SCIENCES 2% STATICIN WESTWOOD SQUIBB 1.5% T-STAT WESTWOOD SQUIBB 2% SWAB; TOPICAL C-SOLVE-2 IVAX SUB TEVA PHARMS 2% ERYCETTE ORTHO JANSSEN 2% ERYTHROMYCIN COREPHARMA 2% T-STAT WESTWOOD SQUIBB 2% TABLET, DELAYED RELEASE; ORAL E-BASE BARR 333MG

6 - 127 (of 346)

A062546 A062618 A062648 N050593 A063098

001 001 001 001 001

Jul 25, 1985 Sep 25, 1985 Oct 24, 1985 Jul 22, 1985 May 04, 1989

A063107

001

Aug 23, 1991

A062467

001

Jul 03, 1985

A062446 A062481 N050368

001 001 001

Sep 26, 1983 Apr 05, 1984

N050610

001

Nov 07, 1986

A062405 A062468 A062290 A062508 A062328 A062326 A062327 A062342 A062957 A064039 A064127 N050532 A062485 A062616 A062522 N050526 A062436

001 001 001 002 001 001 001 001 001 001 001 001 001 001 001 001 001

Nov 18, 1982 Jul 03, 1985

Jul 11, 1985 Apr Apr Apr Feb Jul Jan Feb 19, 19, 19, 25, 21, 27, 14, 1982 1982 1982 1982 1988 1994 1997

Jul 11, 1984 Jul 25, 1985 Jan 24, 1985

Mar 09, 1983

A062751 N050594 A064128 A062748

001 001 001 001

Jul 30, 1993 Feb 15, 1985 Jul 03, 1996 Jul 23, 1987

A063028

001

May 15, 1990

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

ERYTHROMYCIN
TABLET, DELAYED RELEASE; ORAL E-BASE BARR 333MG 500MG E-MYCIN ARBOR PHARMS INC 250MG 333MG ILOTYCIN DISTA 250MG ROBIMYCIN ROBINS AH 250MG R-P MYCIN SOLVAY 250MG

6 - 128 (of 346)

A063086 A062999 A060272 A060272 A061910 A061633 A061659

001 001 001 002 001 001 001

May 15, 1990 Nov 25, 1988

ERYTHROMYCIN ESTOLATE
CAPSULE; ORAL ERYTHROMYCIN ESTOLATE BARR IVAX SUB TEVA PHARMS WATSON LABS ILOSONE LILLY FOR SUSPENSION; ORAL ILOSONE DISTA SUSPENSION; ORAL ERYTHROMYCIN ESTOLATE ALPHARMA US PHARMS BARR LIFE LABS ILOSONE LILLY

EQ EQ EQ EQ

125MG 250MG 250MG 250MG

BASE BASE BASE BASE

A062162 A062162 A062237 A062087 A061897 A061897

001 002 001 001 001 002

EQ 125MG BASE EQ 250MG BASE

EQ 125MG BASE/5ML

A061893

001

EQ EQ EQ EQ EQ EQ EQ EQ EQ

125MG 250MG 125MG 250MG 250MG 125MG 125MG 250MG 250MG

BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML

A062353 A062409 A062169 A062169 A062362 A061894 N050010 A061894 N050010

001 001 001 002 001 001 001 002 002

Nov Dec Oct Oct Dec

18, 16, 17, 17, 17,

1982 1982 1990 1990 1982

SUSPENSION/DROPS; ORAL ILOSONE LILLY TABLET; ORAL ILOSONE LILLY TABLET, CHEWABLE; ORAL ILOSONE DISTA

EQ 100MG BASE/ML

A061894

003

EQ 500MG BASE

A061896

001

EQ 125MG BASE EQ 250MG BASE

A061895 A061895

001 002

ERYTHROMYCIN ESTOLATE; SULFISOXAZOLE ACETYL

SUSPENSION; ORAL ILOSONE SULFA LILLY

EQ 125MG BASE/5ML;EQ 600MG BASE/5ML

N050599

001

Sep 29, 1989

ERYTHROMYCIN ETHYLSUCCINATE
GRANULE; ORAL ERYTHROMYCIN ETHYLSUCCINATE BARR EQ 200MG BASE/5ML PEDIAMYCIN ROSS LABS EQ 200MG BASE/5ML

A062055 A062305

001 001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

ERYTHROMYCIN ETHYLSUCCINATE
SUSPENSION; ORAL E-MYCIN E PHARMACIA AND UPJOHN

6 - 129 (of 346)

EQ 200MG EQ 400MG ERYTHROMYCIN ETHYLSUCCINATE ALPHARMA US PHARMS EQ 200MG EQ 400MG DISTA EQ 200MG EQ 400MG NASKA EQ 400MG PARKE DAVIS EQ 200MG EQ 400MG PHARMAFAIR EQ 200MG EQ 400MG WYAMYCIN E WYETH AYERST EQ 200MG EQ 400MG SUSPENSION/DROPS; ORAL PEDIAMYCIN ROSS LABS EQ 100MG TABLET; ORAL E.E.S. 400

ARBOR PHARMS INC EQ 400MG ERYTHROMYCIN ETHYLSUCCINATE BARR EQ 400MG MYLAN EQ 400MG TABLET, CHEWABLE; ORAL E.E.S. ARBOR PHARMS INC EQ 200MG ERYPED ARBOR PHARMS INC EQ 200MG PEDIAMYCIN

ROSS LABS EQ 200MG

BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML

A062198 A062198 A062200 A062200 A062177 A062177 A062674 A062231 A062231 A062559 A062558 A062123 A062123

001 002 001 002 001 002 001 001 002 001 001 002 001

Mar 10, 1987

Mar 15, 1985 Mar 15, 1985

BASE/2.5ML

A062305

002

BASE BASE BASE

A061905 A062256 A062847

001

001 001

Sep 14, 1988

BASE BASE BASE

N050297 N050297 A062306

002 003 001

Jul 05, 1988

ERYTHROMYCIN ETHYLSUCCINATE; SULFISOXAZOLE ACETYL

GRANULE; ORAL ERYZOLE ALRA PEDIAZOLE ROSS LABS

EQ 200MG BASE/5ML;EQ 600MG BASE/5ML EQ 200MG BASE/5ML;EQ 600MG BASE/5ML

A062758 N050529

001 001

Jun 15, 1988

ERYTHROMYCIN GLUCEPTATE
INJECTABLE; INJECTION ILOTYCIN GLUCEPTATE DISTA

EQ 250MG BASE/VIAL EQ 500MG BASE/VIAL EQ 1GM BASE/VIAL

N050370 N050370 N050370

001 002 003

ERYTHROMYCIN LACTOBIONATE
INJECTABLE; INJECTION ERYTHROCIN ABBOTT HOSPIRA

EQ EQ EQ EQ EQ

500MG BASE/VIAL 1GM BASE/VIAL 500MG BASE/VIAL 1GM BASE/VIAL 1GM BASE/VIAL 500MG BASE/VIAL 1GM BASE/VIAL 500MG BASE/VIAL 1GM BASE/VIAL

A062586 A062586 N050182 N050182 N050609 A062563 A062563 A062604 A062604

001 002 002 003 002 001 002 001 002

Jan 04, 1988 Jan 04, 1988

Sep 24, 1986 Mar 28, 1985 Mar 28, 1985 Nov 24, 1986 Nov 24, 1986

ERYTHROMYCIN ELKINS SINN

EQ EQ ERYTHROMYCIN LACTOBIONATE ABRAXIS PHARM EQ EQ

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

ERYTHROMYCIN LACTOBIONATE
INJECTABLE; INJECTION ERYTHROMYCIN LACTOBIONATE BAXTER HLTHCARE EQ EQ TEVA PARENTERAL EQ EQ

6 - 130 (of 346)

500MG BASE/VIAL 1GM BASE/VIAL 500MG BASE/VIAL 1GM BASE/VIAL

A062993 A062993 A063253 A063253

001 002 001 002

May May Jul Jul

09, 09, 30, 30,

1989 1989 1993 1993

ERYTHROMYCIN STEARATE
TABLET; ORAL BRISTAMYCIN BRISTOL ERYPAR PARKE DAVIS WARNER CHILCOTT ERYTHROCIN STEARATE ARBOR PHARMS INC ERYTHROMYCIN STEARATE BARR IVAX SUB TEVA PHARMS LEDERLE MYLAN PUREPAC PHARM WATSON LABS ETHRIL 250 BRISTOL MYERS SQUIBB ETHRIL 500 BRISTOL MYERS SQUIBB PFIZER-E PFIZER WYAMYCIN S WYETH AYERST

EQ 250MG BASE EQ 250MG BASE EQ 250MG BASE EQ 500MG BASE EQ 250MG BASE EQ 125MG BASE EQ 500MG BASE EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ 250MG 500MG 250MG 500MG 250MG 500MG 250MG 500MG 250MG 250MG 500MG BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE

A061304 A061887 A062032 A062032 A062322 A060359 A060359 A061591 A063179 A061461 A061461 A062089 A062089 A061505 A061505 A061743 A062121 A062121 A061605 A061605 A061791 A061791 A061675 A061675

001 001 001 002 001 002 003 001 001 001 002 001 002 001 002 001 002 001 001 002 001 002 001 002

May 15, 1990

EQ 250MG BASE EQ 500MG BASE EQ 250MG BASE EQ 500MG BASE EQ 250MG BASE EQ 500MG BASE

ESCITALOPRAM OXALATE
CAPSULE; ORAL ESCITALOPRAM OXALATE MYLAN PHARMS INC

EQ 5MG BASE EQ 10MG BASE EQ 20MG BASE

A077660 A077660 A077660

001 002 003

Jul 31, 2007 Jul 31, 2007 Jul 31, 2007

ESMOLOL HYDROCHLORIDE
INJECTABLE; INJECTION BREVIBLOC BAXTER HLTHCARE CORP

10MG/ML 20MG/ML

N019386 N019386

003 007

Aug 15, 1988 May 28, 2003

ESTAZOLAM
TABLET; ORAL PROSOM ABBOTT

1MG 2MG

N019080 N019080

001 002

Dec 26, 1990 Dec 26, 1990

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

ESTRADIOL
FILM, EXTENDED RELEASE; TRANSDERMAL ESCLIM WOMEN FIRST HLTHCARE 0.025MG/24HR 0.0375MG/24HR 0.05MG/24HR 0.075MG/24HR 0.1MG/24HR ESTRADIOL ORTHO MCNEIL PHARM 0.05MG/24HR 0.075MG/24HR 0.1MG/24HR FEMPATCH PARKE DAVIS 0.025MG/24HR VIVELLE NOVARTIS 0.025MG/24HR 0.0375MG/24HR 0.075MG/24HR GEL; TOPICAL ESTROGEL ASCEND 0.06% TABLET; ORAL ESTRACE BRISTOL MYERS SQUIBB 0.5MG ESTRADIOL AAI PHARMA INC 0.5MG 1MG 2MG HERITAGE PHARMS INC 0.5MG 1MG 2MG GYNODIOL DURAMED PHARMS BARR 0.5MG 1MG 1.5MG 2MG INNOFEM NOVO NORDISK INC 0.5MG 1MG 2MG TABLET; VAGINAL VAGIFEM NOVO NORDISK INC 25MCG

6 - 131 (of 346)

N020847 N020847 N020847 N020847 N020847 N021048 N021048 N021048 N020417 N020323 N020323 N020323

001 002 003 004 005 001 002 003 001 005 001 003

Aug Aug Aug Aug Aug

04, 04, 04, 04, 04,

1998 1998 1998 1998 1998

Sep 20, 1999 Sep 20, 1999 Sep 20, 1999 Dec 03, 1996 Aug 16, 2000 Oct 28, 1994 Oct 28, 1994

N021166

001

Feb 09, 2004

A081295 A040138 A040138 A040138 A040275 A040275 A040275 A040212 A040212 A040212 A040212 A040312 A040312 A040312

001 001 002 003 001 002 003 001 002 003 004 001 002 003

Jun 30, 1993 Jan Jan Jan Dec Dec Dec Dec Dec Dec Dec 30, 30, 30, 29, 29, 29, 29, 29, 29, 29, 1998 1998 1998 1998 1998 1998 1997 1997 1997 1997

Nov 19, 1999 Nov 19, 1999 Nov 19, 1999

N020908

001

Mar 26, 1999

ESTRADIOL CYPIONATE
INJECTABLE; INJECTION DEPO-ESTRADIOL PHARMACIA AND UPJOHN

1MG/ML 3MG/ML

A085470 A085470

001 002

ESTRADIOL CYPIONATE; MEDROXYPROGESTERONE ACETATE

INJECTABLE; INTRAMUSCULAR LUNELLE PHARMACIA AND UPJOHN 5MG/0.5ML;25MG/0.5ML

N020874

001

Oct 05, 2000

ESTRADIOL CYPIONATE; TESTOSTERONE CYPIONATE

INJECTABLE; INJECTION DEPO-TESTADIOL PHARMACIA AND UPJOHN 2MG/ML;50MG/ML TESTOSTERONE CYPIONATE-ESTRADIOL CYPIONATE WATSON LABS 2MG/ML;50MG/ML

N017968 A085603

001 001 Mar 13, 1986

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

ESTRADIOL VALERATE
INJECTABLE; INJECTION ESTRADIOL VALERATE WATSON LABS

6 - 132 (of 346)

10MG/ML

A083546

001

ESTRADIOL VALERATE; TESTOSTERONE ENANTHATE

INJECTABLE; INJECTION DITATE-DS SAVAGE LABS 8MG/ML;180MG/ML TESTOSTERONE ENANTHATE AND ESTRADIOL VALERATE WATSON LABS 4MG/ML;90MG/ML 8MG/ML;180MG/ML

A086423 A085865 A085860

001 001 001

ESTROGENS, CONJUGATED
TABLET; ORAL PREMARIN WYETH PHARMS INC

2.5MG

N004782

002

ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE

TABLET; ORAL-28 PREMPHASE (PREMARIN;CYCRIN 14/14) WYETH PHARMS INC 0.625MG,0.625MG;N/A,5MG PREMPRO (PREMARIN;CYCRIN) WYETH PHARMS INC 0.625MG,0.625MG;2.5MG,2.5MG

N020303 N020303

002 001

Dec 30, 1994 Dec 30, 1994

ESTROGENS, CONJUGATED; MEPROBAMATE

TABLET; ORAL MILPREM-200 MEDPOINTE PHARM HLC MILPREM-400 MEDPOINTE PHARM HLC PMB 200 WYETH AYERST PMB 400 WYETH AYERST

0.45MG;200MG 0.45MG;400MG 0.45MG;200MG 0.45MG;400MG

N011045 N011045 N010971 N010971

002 001 005 003

ESTROGENS, ESTERIFIED
TABLET; ORAL AMNESTROGEN BRISTOL MYERS SQUIBB

0.3MG 0.625MG 1.25MG 2.5MG 0.625MG 1.25MG 2.5MG 1.25MG 0.3MG 0.625MG 1.25MG 2.5MG 0.625MG 1.25MG 0.625MG 1.25MG 2.5MG

A083266 A083266 A083266 A083266 A083414 A083765 A085907 A085302 A086715 A083209 A083856 A083857 A084215 A083376 A085076 A085008 A085007

001 002 003 004 001 001 001 001 001 001 001 001 001 002 001 001 001

ESTERIFIED ESTROGENS PVT FORM

SANDOZ ESTRATAB SOLVAY

EVEX ROCHE PALO FEMOGEN PVT FORM

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

ESTRONE
INJECTABLE; INJECTION ESTROGENIC SUBSTANCE WYETH AYERST 2MG/ML ESTRONE WATSON LABS 2MG/ML NATURAL ESTROGENIC SUBSTANCE-ESTRONE WATSON LABS 2MG/ML THEELIN PARKEDALE 1MG/ML 2MG/ML 5MG/ML

6 - 133 (of 346)

A083488 A083397 A085237 N003977 N003977 N003977

001 001 001 001 002 003 Nov 23, 1982

ESTROPIPATE
CREAM; VAGINAL OGEN PHARMACIA AND UPJOHN TABLET; ORAL ESTROPIPATE DURAMED PHARMS BARR

1.5MG/GM

A084710

001

MYLAN

0.75MG 1.5MG 3MG 3MG

A040296 A040296 A040296 A040359

001 002 003 003

Nov Nov Nov Aug

01, 01, 01, 26,

1999 1999 1999 1999

ESZOPICLONE
TABLET; ORAL ESZOPICLONE LUPIN LTD

TEVA

WOCKHARDT LTD

1MG 2MG 3MG 1MG 2MG 3MG 1MG 2MG 3MG

A091124 A091124 A091124 A091169 A091169 A091169 A091165 A091165 A091165

001 002 003 001 002 003 001 002 003

Sep Sep Sep May May May Jul Jul Jul

13, 13, 13, 23, 23, 23, 14, 14, 14,

2011 2011 2011 2011 2011 2011 2011 2011 2011

ETHACRYNIC ACID
TABLET; ORAL EDECRIN ATON

50MG

N016092

002

ETHAMBUTOL HYDROCHLORIDE
TABLET; ORAL MYAMBUTOL STI PHARMA LLC

200MG 500MG

N016320 N016320

002 004

ETHCHLORVYNOL
CAPSULE; ORAL ETHCHLORVYNOL BANNER PHARMACAPS

100MG 200MG 500MG 750MG 100MG 200MG 500MG 750MG

A084463 A084463 A084463 A084463 N010021 N010021 N010021 N010021

001 002 003 004 004 007 002 010

PLACIDYL ABBOTT

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

ETHINAMATE
CAPSULE; ORAL

VALMID

DISTA

6 - 134 (of 346)

500MG

N009750

001

ETHINYL ESTRADIOL
TABLET; ORAL ESTINYL SCHERING

0.02MG 0.05MG 0.5MG 0.05MG 0.01MG 0.05MG

N005292 N005292 N005292 N016649 N005490 N005490

001 002 003 001 003 002

FEMINONE PHARMACIA AND UPJOHN LYNORAL ORGANON USA INC

ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE

TABLET; ORAL-21 DEMULEN 1/35-21 GD SEARLE LLC DEMULEN 1/50-21 GD SEARLE LLC ZOVIA 1/35E-21 WATSON LABS ZOVIA 1/50E-21 WATSON LABS TABLET; ORAL-28 DEMULEN 1/35-28 GD SEARLE LLC DEMULEN 1/50-28 GD SEARLE LLC

0.035MG;1MG 0.05MG;1MG 0.035MG;1MG 0.05MG;1MG

N018168 N016927 A072720 A072722

001 001 001 001 Dec 30, 1991 Dec 30, 1991

0.035MG;1MG 0.05MG;1MG

N018160 N016936

001 001

ETHINYL ESTRADIOL; FERROUS FUMARATE; NORETHINDRONE

TABLET; ORAL-28 NORQUEST FE GD SEARLE LLC

0.035MG;75MG;1MG

N018926

001

Jul 18, 1986

ETHINYL ESTRADIOL; FERROUS FUMARATE; NORETHINDRONE ACETATE

TABLET; ORAL-28

NORLESTRIN FE 1/50
PARKE DAVIS
NORLESTRIN FE 2.5/50
PARKE DAVIS

0.05MG;75MG;1MG 0.05MG;75MG;2.5MG

N016766 N016854

001

001

ETHINYL ESTRADIOL; LEVONORGESTREL

TABLET; ORAL PREVEN EMERGENCY CONTRACEPTIVE KIT DURAMED 0.05MG;0.25MG TABLET; ORAL-21 ALESSE WYETH PHARMS 0.02MG;0.1MG AVIANE-21 DURAMED PHARMS BARR 0.02MG;0.1MG ENPRESSE-21 DURAMED PHARMS BARR 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.1 25MG LESSINA-21 BARR 0.02MG;0.1MG LEVLITE BAYER HLTHCARE 0.02MG;0.1MG LEVONORGESTREL AND ETHINYL ESTRADIOL BARR 0.02MG;0.1MG

N020946

001

Sep 01, 1998

N020683 A075796 A075809

001 002 001

Mar 27, 1997 Apr 30, 2001 Jul 16, 2001

A075803 N020860 A075862

001 001 001

Mar 20, 2002 Jul 13, 1998 Apr 29, 2003

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

ETHINYL ESTRADIOL; LEVONORGESTREL
TABLET; ORAL-21 LEVORA 0.15/30-21 WATSON LABS NORDETTE-21 DURAMED RES PORTIA-21 BARR TRIPHASIL-21 WYETH PHARMS TRIVORA-21 WATSON LABS

6 - 135 (of 346)

0.03MG;0.15MG 0.03MG;0.15MG 0.03MG;0.15MG

A073592 N018668 A075866

001 001 001 001

Dec 13, 1993 May 10, 1982 May 23, 2002 Nov 01, 1984

0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.1 N019192 25MG 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.1 A074538 25MG

001

Dec 18, 1997

TABLET; ORAL-28 ALESSE WYETH PHARMS 0.02MG;0.1MG LEVLITE BAYER HLTHCARE 0.02MG;0.1MG LEVONORGESTREL AND ETHINYL ESTRADIOL BARR 0.02MG;0.1MG TRIPHASIL-28 WYETH PHARMS INC 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.1 25MG

N020683 N020860 A075862 N019190

002 002 002 001

Mar 27, 1997 Jul 13, 1998 Apr 29, 2003 Nov 01, 1984

ETHINYL ESTRADIOL; NORETHINDRONE

TABLET; ORAL-21 BALZIVA-21 BARR 0.035MG;0.4MG BREVICON 21-DAY WATSON LABS 0.035MG;0.5MG GENCEPT 10/11-21 BARR 0.035MG,0.035MG;0.5MG,1MG MODICON 21 ORTHO MCNEIL PHARM 0.035MG;0.5MG N.E.E. 1/35 21 LPI 0.035MG;1MG NORCEPT-E 1/35 21 ORTHO MCNEIL PHARM 0.035MG;1MG NORETHINDRONE AND ETHINYL ESTRADIOL WATSON LABS 0.035MG;0.5MG NORTREL 0.5/35-21 BARR 0.035MG;0.5MG ORTHO-NOVUM 1/35-21 ORTHO MCNEIL PHARM 0.035MG;1MG ORTHO-NOVUM 10/11-21 ORTHO MCNEIL JANSSEN 0.035MG,0.035MG;0.5MG,1MG ORTHO-NOVUM 7/14-21 ORTHO MCNEIL PHARM 0.035MG,0.035MG;0.5MG,1MG ORTHO-NOVUM 7/7/7-21 JANSSEN PHARMS 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1M G OVCON-35 WARNER CHILCOTT 0.035MG;0.4MG OVCON-50 WARNER CHILCOTT 0.05MG;1MG TRI-NORINYL 21-DAY
WATSON LABS 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG TABLET; ORAL-28 GENCEPT 10/11-28 BARR 0.035MG,0.035MG;0.5MG,1MG N.E.E. 1/35 28 LPI 0.035MG;1MG

A076198 N017566 A072694 N017488 A071541 A071545 A070684 A072692 N017489 N018354 N019004 N018985

001 001 001 001 001 001 001 001 002 001 001 001

Apr 22, 2004

Feb 28, 1992

Dec 14, 1987 Feb 09, 1989 Jan 29, 1987 Feb 28, 1992

Jan 11, 1982 Apr 04, 1984 Apr 04, 1984

N018127 N018128 N018977

001 001
001 Apr 13, 1984

A072697 A071542

001 001

Feb 28, 1992 Dec 14, 1987

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

ETHINYL ESTRADIOL; NORETHINDRONE
TABLET; ORAL-28 NORCEPT-E 1/35 28 ORTHO MCNEIL PHARM ORTHO-NOVUM 10/11-28 ORTHO MCNEIL JANSSEN ORTHO-NOVUM 7/14-28 ORTHO MCNEIL PHARM

6 - 136 (of 346)

0.035MG;1MG 0.035MG,0.035MG;0.5MG,1MG 0.035MG,0.035MG;0.5MG,1MG

A071546 N018354 N019004

001 002 002

Feb 09, 1989 Jan 11, 1982 Apr 04, 1984

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

TABLET; ORAL-21 ESTROSTEP 21 WARNER CHILCOTT NORLESTRIN 21 1/50 PARKE DAVIS NORLESTRIN 21 2.5/50 PARKE DAVIS TABLET; ORAL-28 NORLESTRIN 28 1/50 PARKE DAVIS

0.02MG,0.03MG,0.035MG;1MG,1MG,1MG 0.05MG;1MG 0.05MG;2.5MG

N020130 N016749 N016852

001 001 001

Oct 09, 1996

0.05MG;1MG

N016723

001

ETHINYL ESTRADIOL; NORGESTIMATE

TABLET; ORAL-21 ORTHO CYCLEN-21 JANSSEN PHARMS ORTHO TRI-CYCLEN JANSSEN PHARMS

0.035MG;0.25MG

N019653

001 002

Dec 29, 1989 Jul 03, 1992

0.035MG,0.035MG,0.035MG;0.18MG,0.215MG, N019697 0.25MG

ETHINYL ESTRADIOL; NORGESTREL

TABLET; ORAL-21 LO/OVRAL WYETH PHARMS INC OGESTREL 0.5/50-21 WATSON LABS OVRAL WYETH PHARMS TABLET; ORAL-28 OVRAL-28 WYETH PHARMS

0.03MG;0.3MG 0.05MG;0.5MG 0.05MG;0.5MG

N017612 A075406 N016672

001 001 001 Dec 15, 1999

0.05MG;0.5MG

N016806

001

ETHIODIZED OIL
OIL; INTRALYMPHATIC

ETHIODOL

GUERBET

99%

N009190

001

ETHOPROPAZINE HYDROCHLORIDE
TABLET; ORAL

PARSIDOL

PARKE DAVIS

10MG 50MG 100MG

N009078 N009078 N009078

003

006

008

ETHOTOIN

TABLET; ORAL

PEGANONE
LUNDBECK INC

500MG

N010841

003

ETHOXZOLAMIDE
TABLET; ORAL

CARDRASE

PHARMACIA AND UPJOHN

62.5MG 125MG

N011047 N011047

002

001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

ETHOXZOLAMIDE
TABLET; ORAL ETHAMIDE ALLERGAN

6 - 137 (of 346)

125MG

N016144

001

ETHYLESTRENOL
ELIXIR; ORAL MAXIBOLIN ORGANON USA INC TABLET; ORAL MAXIBOLIN ORGANON USA INC

2MG/5ML

N014006

002

2MG

N014005

002

ETHYNODIOL DIACETATE; MESTRANOL

TABLET; ORAL-20 OVULEN GD SEARLE LLC TABLET; ORAL-21 OVULEN-21 GD SEARLE LLC TABLET; ORAL-28 OVULEN-28 GD SEARLE LLC

1MG;0.1MG

N016029

002

1MG;0.1MG

N016029

003

1MG;0.1MG

N016705

001

ETIDOCAINE HYDROCHLORIDE
INJECTABLE; INJECTION DURANEST ASTRAZENECA

0.5% 1%

N017751 N017751

003 005

ETIDRONATE DISODIUM
INJECTABLE; INJECTION DIDRONEL MGI PHARMA INC

50MG/ML

N019545

001

Apr 20, 1987

ETODOLAC
CAPSULE; ORAL ETODOLAC AAIPHARMA LLC ENDO PHARMS IVAX SUB TEVA PHARMS MYLAN

SANDOZ

TEVA WATSON LABS LODINE WYETH PHARMS INC TABLET; ORAL ETODOLAC AAIPHARMA LLC ACTAVIS ELIZABETH ENDO PHARMS

300MG 200MG 300MG 200MG 300MG 200MG 200MG 300MG 300MG 200MG 200MG 300MG 300MG 200MG 200MG 300MG 200MG 300MG

A074929 A074842 A074842 A074899 A074899 A074932 A075071 A074932 A075071 A074840 A074942 A074840 A074942 A075126 A074844 A074844 N018922 N018922

001 001 002 001 002 001 001 002 002 001 001 002 002 001 001 002 002 003

Jan Jul Jul Jul Jul May Sep May Sep Aug Sep Aug Sep Sep Dec Dec

30, 17, 17, 08, 08, 16, 30, 16, 30, 29, 30, 29, 30, 16, 23, 23,

1998 1997 1997 1997 1997 1997 1998 1997 1998 1997 1997 1997 1997 1999 1997 1997

Jan 31, 1991 Jan 31, 1991

400MG 400MG 500MG 400MG

A074927 A074819 A074819 A074841

001 001 002 001

Oct Feb Apr Jun

30, 28, 28, 27,

1997 1997 1998 1997

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

ETODOLAC
TABLET; ORAL ETODOLAC IVAX SUB TEVA PHARMS MYLAN RANBAXY SANDOZ TEVA WATSON LABS

6 - 138 (of 346)

400MG 500MG 400MG 500MG 400MG 500MG 400MG 400MG 400MG 500MG 400MG 400MG 500MG

A074883 A074883 A075012 A075012 A075226 A075226 A074839 A074846 A074847 A074847 A074892 A075069 A074892 N018922 N018922

001 002 001 002 001 002 001 001 001 002 001 001 002 004 005

Feb Nov Sep Sep Nov Nov Jul Feb Apr Apr Apr Apr Oct

28, 20, 30, 30, 24, 24, 11, 28, 23, 23, 16, 16, 29,

1997 1998 1998 1998 1998 1998 1997 1997 1999 1999 1997 1998 1998

400MG 500MG TABLET, EXTENDED RELEASE; ORAL ETODOLAC POINT HOLDINGS 400MG SANDOZ 400MG 500MG 600MG WATSON LABS FLORIDA 400MG 500MG LODINE XL WYETH PHARMS INC 400MG 500MG 600MG

LODINE WYETH PHARMS INC

Jul 29, 1993 Jun 28, 1996

A075696 A075943 A075943 A075943 A075829 A075829 N020584 N020584 N020584

001 001 002 003 001 002 001 003 002

Jul Jul Jul Jul Nov Nov

31, 26, 26, 26, 30, 30,

2000 2002 2002 2002 2001 2001

Oct 25, 1996 Jan 20, 1998 Oct 25, 1996

ETOPOSIDE
CAPSULE; ORAL VEPESID BRISTOL MYERS SQUIBB INJECTABLE; INJECTION ETOPOSIDE HOSPIRA MARSAM PHARMS LLC PIERRE FABRE TEVA PARENTERAL WATSON LABS TOPOSAR TEVA PARENTERAL VEPESID BRISTOL MYERS SQUIBB

50MG 100MG

N019557 N019557

001 002

Dec 30, 1986 Dec 30, 1986

20MG/ML 20MG/ML 20MG/ML 20MG/ML 20MG/ML 20MG/ML 20MG/ML 20MG/ML

A074320 A074351 A074968 A074813 A074510 A074228 A074166 N018768

001 001 001 001 001 001 001 001

Aug Aug Jan Jul Jun Oct

30, 30, 09, 09, 29, 15,

1995 1995 1998 1997 1995 1996

Feb 27, 1995 Nov 10, 1983

ETOPOSIDE PHOSPHATE
INJECTABLE; INJECTION ETOPOPHOS PRESERVATIVE FREE BRISTOL MYERS SQUIBB EQ 500MG BASE/VIAL EQ 1GM BASE/VIAL

N020906 N020906

001 002

Feb 27, 1998 Feb 27, 1998

ETRETINATE
CAPSULE; ORAL TEGISON ROCHE

10MG 25MG

N019369 N019369

001 002

Sep 30, 1986 Sep 30, 1986

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

EVANS BLUE
INJECTABLE; INJECTION EVANS BLUE PARKE DAVIS

6 - 139 (of 346)

0.5%

N008041

001

FAMOTIDINE
INJECTABLE; INJECTION FAMOTIDINE APOTEX INC APOTHECON HOSPIRA

10MG/ML 10MG/ML 10MG/ML 10MG/ML 10MG/ML FAMOTIDINE PRESERVATIVE FREE APOTHECON 10MG/ML HOSPIRA 10MG/ML FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER ABBOTT 0.4MG/ML PEPCID MERCK 10MG/ML PEPCID PRESERVATIVE FREE MERCK 10MG/ML PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER MERCK 0.4MG/ML TABLET; ORAL FAMOTIDINE ACTAVIS ELIZABETH 20MG 40MG APOTEX 10MG MUTUAL PHARM 20MG 40MG SANDOZ 20MG 20MG 40MG 40MG TABLET, CHEWABLE; ORAL PEPCID AC MERCK SHARP DOHME 10MG TABLET, ORALLY DISINTEGRATING; ORAL FLUXID SCHWARZ PHARMA 20MG 40MG PEPCID RPD MERCK 20MG 40MG

A075942 A075707 A075705 A075870 A075905 A075708 A075669 A075729 N019510 N019510 N020249

001 001 001 001 001 001 001 001 001 004 001

Aug Apr Apr Nov Nov

02, 16, 16, 23, 23,

2002 2001 2001 2001 2001

Apr 16, 2001 Apr 16, 2001 Dec 17, 2001 Nov 04, 1986 Nov 04, 1986 Feb 18, 1994

A075650 A075650 A075610 A075639 A075639 A075302 A075793 A075302 A075793

001 002 001 002 001 001 001 002 002

Sep Sep Mar Dec Dec Apr Apr Apr Apr

14, 14, 12, 12, 12, 16, 16, 16, 16,

2001 2001 2002 2001 2001 2001 2001 2001 2001

N020801

001

Sep 24, 1998

N021712 N021712 N020752 N020752

001 002 001 002

Sep 24, 2004 Sep 24, 2004 May 28, 1998 May 28, 1998

FENOFIBRATE
CAPSULE; ORAL ANTARA (MICRONIZED) LUPIN ATLANTIS LIPIDIL ABBOTT LIPOFEN CIPHER PHARMS INC TRICOR (MICRONIZED) ABBOTT

87MG 100MG 100MG 67MG 134MG 200MG

N021695 N019304 N021612 N019304 N019304 N019304

002 001 002 002 003 004

Nov 30, 2004 Dec 31, 1993 Jan 11, 2006 Feb 09, 1998 Jun 30, 1999 Jun 30, 1999

TABLET; ORAL FENOFIBRATE MYLAN TRICOR ABBOTT

107MG 54MG 160MG

A076520 N021203 N021203

002 001 003

Dec 29, 2005 Sep 04, 2001 Sep 04, 2001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

FENOLDOPAM MESYLATE
INJECTABLE; INJECTION FENOLDOPAM MESYLATE LUITPOLD TEVA PARENTERAL

6 - 140 (of 346)

EQ 10MG BASE/ML EQ 10MG BASE/ML

A076656 A077826

001 001

Dec 01, 2003 Mar 07, 2007

FENOPROFEN CALCIUM
CAPSULE; ORAL FENOPROFEN CALCIUM AM THERAP HALSEY PAR PHARM QUANTUM PHARMICS SANDOZ WARNER CHILCOTT WATSON LABS

EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ

200MG 300MG 200MG 300MG 200MG 300MG 200MG 300MG 200MG 300MG 200MG 300MG 200MG 200MG 300MG 300MG

BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE

A072307 A072308 A072355 A072356 A072437 A072438 A072214 A071738 A072394 A072395 A072946 A072472 A072294 A072981 A072293 A072982 N017604

001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 002

Aug Aug Aug Aug Aug Aug Aug Aug Oct Oct Apr Apr Aug Aug Aug Aug

22, 22, 17, 17, 22, 22, 17, 17, 17, 17, 30, 30, 17, 19, 17, 19,

1988 1988 1988 1988 1988 1988 1988 1988 1988 1988 1991 1991 1988 1991 1988 1991

NALFON PEDINOL TABLET; ORAL FENOPROFEN CALCIUM ACTAVIS ELIZABETH AM THERAP CLONMEL HLTHCARE HALSEY MUTUAL PHARM PAR PHARM QUANTUM PHARMICS SANDOZ USL PHARMA WATSON LABS

EQ 300MG BASE

EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ

600MG 600MG 600MG 600MG 600MG 600MG 600MG 600MG 600MG 600MG 600MG 600MG

BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE

A072274 A072309 A072326 A072357 A072902 A072429 A072194 A072396 A072362 A072165 A072407 A072602 N017710

001 001 001 001 001 001 001 001 001 001 001 001 001

May Aug Aug Aug Dec Aug Aug Oct Aug Aug Aug Oct

02, 17, 17, 17, 21, 17, 17, 17, 17, 17, 17, 11,

1988 1988 1988 1988 1990 1988 1988 1988 1988 1988 1988 1988

NALFON DISTA

EQ 600MG BASE

FENTANYL CITRATE
INJECTABLE; INJECTION FENTANYL CITRATE ABBOTT

EQ 0.05MG BASE/ML EQ 0.05MG BASE/ML WATSON LABS EQ 0.05MG BASE/ML FENTANYL CITRATE PRESERVATIVE FREE MARSAM PHARMS LLC EQ 0.05MG BASE/ML TABLET; BUCCAL FENTORA CEPHALON EQ 0.3MG BASE TROCHE/LOZENGE; ORAL FENTANYL CEPHALON EQ 0.1MG BASE EQ 0.2MG BASE EQ 0.3MG BASE EQ 0.4MG BASE

A070636 A070637 A073488 A074917

001 001 001 001

Apr 30, 1990 Apr 30, 1990 Jun 30, 1992 Feb 03, 1998

N021947

006

Mar 02, 2007

N020195 N020195 N020195 N020195

007 001 002 003

Oct Oct Oct Oct

30, 04, 04, 04,

1995 1993 1993 1993

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

FENTANYL HYDROCHLORIDE
SYSTEM; IONTOPHORESIS, TRANSDERMAL IONSYS INCLINE THERAP 10.8MCG

6 - 141 (of 346)

N021338

001

May 22, 2006

FERRIC AMMONIUM CITRATE

FOR SOLUTION; ORAL FERRISELTZ OTSUKA

600MG/PACKET

N020292

001

Oct 14, 1997

FERROUS CITRATE, FE-59

INJECTABLE; INJECTION FERROUS CITRATE FE 59 MALLINCKRODT

25uCi/ML

N016729

001

FERROUS SULFATE; FOLIC ACID

CAPSULE; ORAL FOLVRON LEDERLE

182MG;0.33MG

N006012

003

FEXOFENADINE HYDROCHLORIDE
CAPSULE; ORAL ALLEGRA SANOFI AVENTIS US 60MG FEXOFENADINE HYDROCHLORIDE BARR 60MG

N020625 A076169

001 001

Jul 25, 1996 Jul 13, 2005

FIBRINOGEN, I-125
INJECTABLE; INJECTION IBRIN GE HEALTHCARE 154uCi/VIAL RADIONUCLIDE-LABELED (125 I) FIBRINOGEN (HUMAN) SENSOR ABBOTT 140uCi/ML

N017879 N017787

001 001

FINASTERIDE
TABLET; ORAL FINASTERIDE IVAX SUB TEVA PHARMS

5MG

A076340

001

Jun 19, 2006

FLAVOXATE HYDROCHLORIDE
TABLET; ORAL URISPAS ORTHO MCNEIL JANSSEN

100MG

N016769

001

FLECAINIDE ACETATE
TABLET; ORAL FLECAINIDE ACETATE SANDOZ

50MG 100MG 150MG 200MG

A076030 A076030 A076030 N018830

001 002 003 002

Oct 28, 2002 Oct 28, 2002 Oct 28, 2002 Oct 31, 1985

TAMBOCOR MEDICIS

FLOXURIDINE
INJECTABLE; INJECTION FUDR HOSPIRA

500MG/VIAL

N016929

001

FLUCONAZOLE
INJECTABLE; INJECTION
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
APOTEX INC 200MG/100ML (2MG/ML) 400MG/200ML (2MG/ML)

A076889 A076889

001 002

Mar 25, 2005 Mar 25, 2005

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

FLUCONAZOLE
INJECTABLE; INJECTION FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HOSPIRA 200MG/100ML (2MG/ML) 400MG/200ML (2MG/ML) TABLET; ORAL FLUCONAZOLE GEDEON RICHTER USA 50MG 100MG 150MG 200MG ROXANE 50MG 100MG 150MG 200MG SANDOZ 50MG 100MG 150MG 200MG

6 - 142 (of 346)

A076617 A076617

001 002

Jul 29, 2004 Jul 29, 2004

A076432 A076432 A076432 A076432 A076213 A076213 A076213 A076213 A076086 A076086 A076086 A076086

001 002 003 004 001 002 003 004 001 002 003 004

Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul Jul

29, 29, 29, 29, 29, 29, 29, 29, 29, 29, 29, 29,

2004 2004 2004 2004 2004 2004 2004 2004 2004 2004 2004 2004

FLUDEOXYGLUCOSE F-18
INJECTABLE; INJECTION FLUDEOXYGLUCOSE F 18 DOWNSTATE CLINCL

4-40mCi/ML 4-90mCi/ML

N020306 N020306

001 002

Aug 19, 1994 Sep 25, 2001

FLUDROCORTISONE ACETATE
TABLET; ORAL FLORINEF KING PHARMS

0.1MG

N010060

001

FLUMETHASONE PIVALATE
CREAM; TOPICAL LOCORTEN NOVARTIS

0.03%

N016379

001

FLUNISOLIDE
SPRAY, METERED; NASAL NASALIDE IVAX RES NASAREL TEVA BRANDED PHARM

0.025MG/SPRAY 0.029MG/SPRAY

N018148 N020409

001 001 Mar 08, 1995

FLUOCINOLONE ACETONIDE
CREAM; TOPICAL FLUOCET ALPHARMA US PHARMS FLUOCINOLONE ACETONIDE ALPHARMA US PHARMS PERRIGO NEW YORK PHARMADERM PHARMAFAIR TARO

0.025% 0.01% 0.01% 0.025% 0.01% 0.025% 0.01% 0.025% 0.01% 0.01% 0.025% 0.01% 0.025% 0.025%

A088360 A088361 A086810 A086811 A088047 A088045 A088499 A088506 A040035 A087102 A040042 A088757 A088756 A087156

001 001 001 001 001 001 001 001 001 001 001 001 001 002

Jan 16, 1984 Jan Mar Mar Dec Dec Aug Aug Oct Apr Oct Feb Mar 16, 04, 04, 16, 16, 02, 02, 31, 27, 31, 11, 28, 1984 1982 1982 1982 1982 1984 1984 1994 1982 1994 1985 1985

USL PHARMA FLUONID ALLERGAN HERBERT

Sep 06, 1984

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

FLUOCINOLONE ACETONIDE
CREAM; TOPICAL FLUOTREX SAVAGE LABS SYNALAR-HP MEDIMETRIKS PHARMS GEL; TOPICAL FLUONID ALLERGAN HERBERT OINTMENT; TOPICAL FLUOCINOLONE ACETONIDE PHARMADERM PHARMAFAIR USL PHARMA FLUONID ALLERGAN HERBERT FLUOTREX SAVAGE LABS SOLUTION; TOPICAL FLUOCINOLONE ACETONIDE ALPHARMA US PHARMS BAUSCH AND LOMB MORTON GROVE PHARMADERM PHARMAFAIR FLUONID ALLERGAN HERBERT FLUOTREX SAVAGE LABS

6 - 143 (of 346)

0.01% 0.025% 0.2%

A088174 A088173 N016161

001 001 002

May 06, 1983 Mar 09, 1983

0.025%

A087300

001

May 27, 1982

0.025% 0.025% 0.025% 0.025% 0.025%

A088046 A088507 A088742 A087157 A088172

001 001 001 001 001

Dec 16, 1982 Feb 27, 1984 Feb 08, 1985 Sep 06, 1984 Mar 09, 1983

0.01% 0.01% 0.01% 0.01% 0.01% 0.01% 0.01%

A087159 A040059 A088312 A088048 A088449 A087158 A088171

001 001 001 001 001 001 001

Jun Dec Jan Dec Feb

16, 20, 27, 16, 08,

1982 1993 1984 1982 1984

Mar 17, 1983 Mar 09, 1983

FLUOCINOLONE ACETONIDE; NEOMYCIN SULFATE

CREAM; TOPICAL NEO-SYNALAR MEDIMETRIKS PHARMS

0.025%;EQ 3.5MG BASE/GM

A060700

001

FLUOCINONIDE
CREAM; TOPICAL FLUOCINONIDE PERRIGO NEW YORK TARO FLUOCINONIDE EMULSIFIED ACTAVIS MID ATLANTIC SOLUTION; TOPICAL FLUOCINONIDE TARO TEVA PHARMS

0.05% 0.05% BASE 0.05%

A071790 A071500 A074204

001 001 001

Jul 13, 1988 Jun 10, 1987 Jun 13, 1995

0.05% 0.05%

A072857 A072522

001 001

Aug 02, 1989 Sep 28, 1990

FLUORESCEIN SODIUM
INJECTABLE; INJECTION FUNDUSCEIN-25 NOVARTIS INJECTABLE; INTRAVENOUS AK-FLUOR 25% AKORN

25%

N017869

001

EQ 500MG BASE/2ML (EQ 250MG BASE/ML)

N022186

002

Aug 08, 2008

FLUOROMETHOLONE
CREAM; TOPICAL OXYLONE PHARMACIA AND UPJOHN 0.025% SUSPENSION/DROPS; OPHTHALMIC FLUOR-OP NOVARTIS 0.1%

N011748

001

A070185

001

Feb 27, 1986

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

FLUOROMETHOLONE ACETATE; TOBRAMYCIN
SUSPENSION/DROPS; OPHTHALMIC TOBRASONE ALCON 0.1%;0.3%

6 - 144 (of 346)

N050628

001

Jul 21, 1989

FLUOROMETHOLONE; SULFACETAMIDE SODIUM

SUSPENSION/DROPS; OPHTHALMIC FML-S ALLERGAN 0.1%;10%

N019525

001

Sep 29, 1989

FLUOROURACIL
INJECTABLE; INJECTION ADRUCIL PHARMACIA AND UPJOHN TEVA PARENTERAL FLUOROURACIL ABIC ABRAXIS PHARM

50MG/ML 50MG/ML 50MG/ML 50MG/ML 50MG/ML 50MG/ML 50MG/ML 50MG/ML 50MG/ML 50MG/ML 50MG/ML 50MG/ML 50MG/ML 50MG/ML 50MG/ML 500MG/10ML (50MG/ML) 50MG/ML

A081222 N017959 A040023 A081225 A088929 A089152 A089428 A089519 A040291 A040379 A089508 A087791 A088766 A088767 A089434 N012209 A087792

001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001

Jun 28, 1991 Oct 18, 1991 Aug 28, 1991 Mar Mar Jan Mar Mar Nov Jan Jan Dec Dec Mar 04, 21, 12, 12, 24, 15, 26, 18, 28, 28, 26, 1986 1986 1987 1987 1999 2000 1988 1983 1984 1984 1987

APP PHARMS BEDFORD MARCHAR SMITH AND NEPHEW

VALEANT WATSON LABS SOLUTION; TOPICAL FLUOROPLEX ELORAC

Oct 13, 1982

1%

N016765

001

FLUOXETINE HYDROCHLORIDE
CAPSULE; ORAL FLUOXETINE MUTUAL PHARMA WATSON LABS

EQ EQ EQ EQ

10MG 20MG 10MG 20MG 40MG 10MG 20MG 40MG 10MG 20MG

BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE

A075787 A075787 A075662 A075662 A076251 A076922 A076922 A076922 A075807 A075807 N018936

001 002 001 002 001 001 002 003 001 002 004

Jan Jan Jan Jan May Dec Dec Dec Jan Jan

29, 29, 29, 29, 18, 16, 16, 16, 29, 29,

2002 2002 2002 2002 2005 2004 2004 2004 2002 2002

FLUOXETINE HYDROCHLORIDE BARR EQ PAR PHARM EQ EQ EQ SANDOZ EQ EQ PROZAC LILLY EQ SOLUTION; ORAL FLUOXETINE HYDROCHLORIDE ACTAVIS MID ATLANTIC EQ HI TECH PHARMA EQ PROZAC LILLY EQ TABLET; ORAL FLUOXETINE HYDROCHLORIDE BARR EQ IVAX SUB TEVA PHARMS EQ EQ SANDOZ EQ

60MG BASE

Jun 15, 1999

20MG BASE/5ML 20MG BASE/5ML 20MG BASE/5ML

A075690 A075525 N020101

001 001 001

Jan 31, 2002 Jun 27, 2002 Apr 24, 1991

10MG 10MG 40MG 10MG

BASE BASE BASE BASE

A075810 A075865 A075865 A076024

001 001 003 001

Feb Feb Aug Jan

01, 28, 30, 29,

2002 2002 2004 2002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

FLUOXETINE HYDROCHLORIDE
TABLET; ORAL PROZAC LILLY

6 - 145 (of 346)

EQ 10MG BASE EQ 20MG BASE

N020974 N020974

001 002

Mar 09, 1999 Mar 09, 1999

FLUOXYMESTERONE
TABLET; ORAL ANDROID-F VALEANT PHARM INTL FLUOXYMESTERONE VALEANT PHARM INTL WATSON LABS

10MG 10MG 2MG 5MG 10MG 2MG 5MG 10MG 2MG 5MG

A087196 A088221 A088260 A088265 A088309 N010611 N010611 N010611 N011359 N011359

001 001 001 001 001 002 006 010 001 002 May Dec Dec Dec 05, 06, 06, 06, 1983 1983 1983 1983

HALOTESTIN PHARMACIA AND UPJOHN

ORA-TESTRYL BRISTOL MYERS SQUIBB

FLUPHENAZINE DECANOATE
INJECTABLE; INJECTION FLUPHENAZINE DECANOATE HOSPIRA TEVA PARENTERAL PROLIXIN DECANOATE BRISTOL MYERS SQUIBB

25MG/ML 25MG/ML 25MG/ML

A074966 A074795 N016727

001 001 001

Apr 16, 1998 Sep 10, 1996

FLUPHENAZINE ENANTHATE
INJECTABLE; INJECTION PROLIXIN ENANTHATE APOTHECON

25MG/ML

N016110

001

FLUPHENAZINE HYDROCHLORIDE
CONCENTRATE; ORAL FLUPHENAZINE HYDROCHLORIDE TEVA PHARMS 5MG/ML PERMITIL SCHERING 5MG/ML PROLIXIN APOTHECON 5MG/ML ELIXIR; ORAL FLUPHENAZINE HYDROCHLORIDE TEVA PHARMS 2.5MG/5ML PROLIXIN APOTHECON 2.5MG/5ML INJECTABLE; INJECTION PROLIXIN APOTHECON 2.5MG/ML TABLET; ORAL FLUPHENAZINE HYDROCHLORIDE WATSON LABS 1MG 2.5MG 5MG 10MG PERMITIL SCHERING 0.25MG 2.5MG 5MG 10MG

A073058 N016008 A070533

001 001 001

Aug 30, 1991

Nov 07, 1985

A081310 N012145

001 003

Apr 29, 1993

N011751

005

A088555 A088544 A088527 A088550 N012034 N012034 N012034 N012034

001 001 001 001 001 004 005 006

Dec Dec Dec Dec

18, 18, 18, 18,

1987 1987 1987 1987

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

FLUPHENAZINE HYDROCHLORIDE
TABLET; ORAL PROLIXIN APOTHECON

6 - 146 (of 346)

1MG 2.5MG 5MG 10MG TABLET, EXTENDED RELEASE; ORAL PERMITIL SCHERING 1MG

N011751 N011751 N011751 N011751

004 001 003 002

N012419

004

FLUPREDNISOLONE
TABLET; ORAL ALPHADROL PHARMACIA AND UPJOHN

1.5MG

N012259

002

FLURANDRENOLIDE
CREAM; TOPICAL CORDRAN SP WATSON PHARMS LOTION; TOPICAL FLURANDRENOLIDE ALPHARMA US PHARMS OINTMENT; TOPICAL CORDRAN WATSON PHARMS

0.05%

N012806

002

0.05%

A087203

001

Apr 29, 1982

0.025% 0.05%

N012806 N012806

004 001

FLURANDRENOLIDE; NEOMYCIN SULFATE

CREAM; TOPICAL CORDRAN-N LILLY OINTMENT; TOPICAL CORDRAN-N LILLY

0.05%;EQ 3.5MG BASE/GM

N050346

001

0.05%;EQ 3.5MG BASE/GM

N050345

001

FLURAZEPAM HYDROCHLORIDE
CAPSULE; ORAL DALMANE VALEANT PHARM INTL

15MG 30MG

N016721 N016721 A071808 A071809 A070454 A070455 A070444 A070445 A071927 A071551 A071716 A071717 A071659 A071660 A070562 A070563 A071767 A071768 A072368

001 002 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 Jan Jan Aug Aug Mar Mar Sep Sep Jul Jul Aug Aug Jul Jul Dec Dec Mar 07, 07, 04, 04, 20, 20, 09, 09, 31, 31, 04, 04, 09, 09, 04, 04, 30, 1988 1988 1986 1986 1986 1986 1987 1987 1991 1991 1988 1988 1987 1987 1987 1987 1989

FLURAZEPAM HYDROCHLORIDE HALSEY 15MG 30MG MUTUAL PHARM 15MG 30MG PAR PHARM 15MG 30MG PUREPAC PHARM 15MG 30MG SANDOZ 15MG 30MG SUPERPHARM 15MG 30MG USL PHARMA 15MG 30MG WARNER CHILCOTT 15MG 30MG WATSON LABS 15MG

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

FLURBIPROFEN
TABLET; ORAL FLURBIPROFEN IVAX SUB TEVA PHARMS PLIVA SANDOZ TEVA THERAGEN

6 - 147 (of 346)

50MG 100MG 50MG 100MG 50MG 100MG 50MG 100MG 100MG

A074411 A074411 A074647 A074647 A074448 A074448 A074405 A074405 A074560

001 002 001 002 001 002 002 001 002

May May Apr Apr Jul Jul May May May

31, 31, 01, 01, 28, 28, 24, 24, 16,

1995 1995 1997 1997 1995 1995 1995 1995 1997

FLUTAMIDE
CAPSULE; ORAL EULEXIN SCHERING

125MG

N018554

001

Jan 27, 1989

FLUTICASONE PROPIONATE
AEROSOL, METERED; INHALATION FLOVENT GLAXOSMITHKLINE 0.044MG/INH 0.11MG/INH 0.22MG/INH OINTMENT; TOPICAL FLUTICASONE PROPIONATE TARO PHARM INDS 0.005% POWDER; INHALATION FLOVENT GLAXOSMITHKLINE 0.044MG/INH 0.088MG/INH 0.22MG/INH

N020548 N020548 N020548

001 002 003

Mar 27, 1996 Mar 27, 1996 Mar 27, 1996

A077145

001

Jun 14, 2005

N020549 N020549 N020549

001 002 003

Nov 07, 1997 Nov 07, 1997 Nov 07, 1997

FLUVOXAMINE MALEATE
TABLET; ORAL FLUVOXAMINE MALEATE ACTAVIS ELIZABETH

IVAX SUB TEVA PHARMS

MUTUAL PHARM

MYLAN SANDOZ

SYNTHON PHARMS

WATSON LABS

25MG 50MG 100MG 25MG 50MG 100MG 25MG 50MG 100MG 50MG 100MG 25MG 50MG 100MG 25MG 50MG 100MG 25MG 50MG 100MG 25MG 50MG 100MG 150MG

A075901 A075901 A075901 A075898 A075898 A075898 A076125 A076125 A076125 A075950 A075950 A075887 A075887 A075887 A075899 A075899 A075899 A075894 A075894 A075894 N020243 N020243 N020243 N020243

001 002 003 001 002 003 001 002 003 001 002 001 002 003 001 002 003 001 002 003 001 002 003 004

Dec Dec Dec Mar Mar Mar Apr Apr Apr Oct Oct Jan Jan Jan Jan Jan Jan Apr Apr Apr Dec Dec Dec Dec

28, 28, 28, 12, 12, 12, 29, 29, 29, 15, 15, 05, 05, 05, 17, 17, 17, 18, 18, 18, 05, 05, 05, 05,

2000 2000 2000 2001 2001 2001 2002 2002 2002 2001 2001 2001 2001 2001 2001 2001 2001 2001 2001 2001 1994 1994 1994 1994

LUVOX SOLVAY

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

FOLIC ACID
INJECTABLE; INJECTION FOLIC ACID BEN VENUE FOLVITE HIKMA (MAPLE) TABLET; ORAL FOLIC ACID BARR EVERYLIFE HALSEY IMPAX LABS IVAX SUB TEVA PHARMS LANNETT LILLY MK LABS MUTUAL PHARM NEXGEN PHARMA INC PHARMERAL PIONEER PHARMS PUREPAC PHARM SANDOZ TABLICAPS UDL USL PHARMA VALEANT PHARM INTL VANGARD VINTAGE PHARMS WATSON LABS WHITEWORTH TOWN PLSN FOLICET MISSION PHARMA FOLVITE HIKMA (MAPLE)

6 - 148 (of 346)

5MG/ML 5MG/ML

A081066 N005897

001 008

Dec 29, 1993

1MG 1MG 1MG 1MG 1MG 1MG 1MG 1MG 1MG 1MG 1MG 1MG 1MG 1MG 1MG 1MG 1MG 1MG 1MG 1MG 1MG 1MG 1MG 1MG 1MG

A089177 A080755 A083598 A080686 A083000 A080816 N006135 A083526 A040582 A084915 A084158 A088949 A080784 A084472 A083133 A088199 A087828 A080903 A088730 A086296 A083141 A085141 A080691 A087438 N005897

001 001 001 001 001 001 003 001 001 001 001 001 001 001 002 001 001 001 001 001 001 002 002 001 004

Jan 08, 1986

Jul 18, 2005

Sep 13, 1985

Mar 29, 1983 May 13, 1982 Mar 23, 1984

FOLLITROPIN ALFA/BETA
INJECTABLE; IM-SC FOLLISTIM ORGANON USA INC INJECTABLE; SUBCUTANEOUS FOLLISTIM AQ ORGANON USA INC GONAL-F EMD SERONO

75 IU/VIAL 150 IU/VIAL

N020582 N020582

001 002

Sep 29, 1997 Sep 29, 1997

150 IU/0.18ML 37.5 IU/VIAL 37.5 IU/VIAL 75 IU/VIAL 150 IU/VIAL 150 IU/VIAL

N021211 N020378 N021765 N020378 N020378 N021765

003 003 001 001 002 003

Feb 11, 2004 May Mar Sep Sep Mar 25, 25, 29, 29, 25, 2000 2004 1997 1997 2004

FOMIVIRSEN SODIUM
INJECTABLE; INJECTION VITRAVENE PRESERVATIVE FREE NOVARTIS 6.6MG/ML

N020961

001

Aug 26, 1998

FORMOTEROL FUMARATE
POWDER; INHALATION FORADIL CERTIHALER NOVARTIS

0.0085MG/INH

N021592

001

Dec 15, 2006

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

FOSINOPRIL SODIUM
TABLET; ORAL FOSINOPRIL SODIUM SANDOZ

6 - 149 (of 346)

10MG 20MG 40MG

A076188 A076188 A076188

001 002 003

Oct 08, 2004 Oct 08, 2004 Oct 08, 2004

FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE

TABLET; ORAL FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TEVA 10MG;12.5MG 20MG;12.5MG WATSON LABS 10MG;12.5MG 20MG;12.5MG MONOPRIL-HCT BRISTOL MYERS SQUIBB 10MG;12.5MG 20MG;12.5MG

A076945 A076945 A077144 A077144 N020286 N020286

001 002 001 002 002 001

Jul Jul Aug Aug

05, 05, 16, 16,

2006 2006 2005 2005

Nov 30, 1994 Nov 30, 1994

FOSPHENYTOIN SODIUM
INJECTABLE; INJECTION CEREBYX PARKE DAVIS

EQ 50MG PHENYTOIN NA/ML

N020450

001

Aug 05, 1996

FURAZOLIDONE
SUSPENSION; ORAL FUROXONE SHIRE TABLET; ORAL FUROXONE SHIRE

50MG/15ML

N011323

002

100MG

N011270

002

FUROSEMIDE
INJECTABLE; INJECTION FUROSEMIDE ABRAXIS PHARM ASTRAZENECA

BAXTER HLTHCARE HOSPIRA MARSAM PHARMS LLC ORGANON USA INC SMITH AND NEPHEW WARNER CHILCOTT WATSON LABS WYETH AYERST LASIX SANOFI AVENTIS US SOLUTION; ORAL LASIX SANOFI AVENTIS US TABLET; ORAL FUROSEMIDE INTL MEDICATION KALAPHARM MUTUAL PHARM

10MG/ML 10MG/ML 10MG/ML 10MG/ML 10MG/ML 10MG/ML 10MG/ML 10MG/ML 10MG/ML 10MG/ML 10MG/ML 10MG/ML 10MG/ML 10MG/ML 10MG/ML 10MG/ML 10MG/ML 10MG/ML

N018507 N019036 A070014 A070095 A070096 A071439 N018267 A072080 A074337 A074017 A070017 A070023 A070078 N018420 A070019 A070604 N018670 N016363

001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001

Jul Aug Sep Sep Sep Sep Aug Oct Jun Dec Feb Feb Feb Sep Jan Jul

30, 13, 09, 09, 09, 14, 13, 31, 30, 15, 05, 05, 26, 22, 02, 20,

1982 1984 1985 1985 1985 1990 1991 1994 1994 1986 1986 1986 1982 1986 1987 1982

10MG/ML

N017688

001

20MG 40MG 20MG 40MG 20MG

N018753 N018753 N018868 N018868 A070043

001 002 001 002 001

Feb Feb Jun Jun Sep

28, 28, 28, 28, 26,

1984 1984 1983 1983 1985

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

FUROSEMIDE
TABLET; ORAL FUROSEMIDE MUTUAL PHARM SANDOZ SUPERPHARM WARNER CHILCOTT

6 - 150 (of 346)

WATSON LABS

40MG 80MG 40MG 20MG 40MG 20MG 40MG 80MG 20MG 40MG 40MG

N018790 A070100 N018750 N018370 N018370 N018419 N018419 N018419 N018369 A070413 N018369

001 001 002 002 001 001 002 003 001 001 002

Nov Jan Jul Jun Feb Jan Jan Nov May Feb May

29, 26, 30, 26, 10, 31, 31, 13, 14, 26, 14,

1983 1988 1984 1984 1983 1983 1983 1984 1982 1986 1982

GABAPENTIN
CAPSULE; ORAL GABAPENTIN IVAX SUB TEVA PHARMS

MUTUAL PHARM

SANDOZ

100MG 300MG 400MG 100MG 300MG 400MG 100MG 100MG 300MG 300MG 400MG 400MG

A075477 A075477 A075477 A076537 A076537 A076537 A075428 A075539 A075428 A075539 A075428 A075539

001 002 003 001 002 003 001 001 002 002 003 003

Mar Mar Mar Jun Jun Jun Jan Apr Jan Apr Jan Apr

23, 23, 23, 30, 30, 30, 24, 06, 24, 06, 24, 06,

2005 2005 2005 2005 2005 2005 2006 2005 2006 2005 2006 2005

TABLET; ORAL GABAPENTIN RANBAXY SANDOZ

TEVA

600MG 800MG 600MG 600MG 800MG 800MG 600MG 800MG

A076605 A076605 A076120 A076877 A076120 A076877 A075827 A075827

001 002 001 001 002 002 001 002

Sep Sep Jan Jul Jan Jul Dec Dec

14, 14, 27, 06, 27, 06, 15, 15,

2005 2005 2006 2006 2006 2006 2004 2004

GADODIAMIDE
INJECTABLE; INJECTION OMNISCAN GE HEALTHCARE

14.35GM/50ML (287MG/ML)

N022066

001

Sep 05, 2007

GALANTAMINE HYDROBROMIDE
TABLET; ORAL GALANTAMINE HYDROBROMIDE ACTAVIS ELIZABETH EQ EQ EQ YABAO BIOPHARMS EQ EQ EQ

4MG BASE 8MG BASE 12MG BASE 4MG BASE 8MG BASE 12MG BASE

A077585 A077585 A077585 A077604 A077604 A077604

001 002 003 001 002 003

Sep Sep Sep Feb Feb Feb

15, 15, 15, 06, 06, 06,

2009 2009 2009 2009 2009 2009

GALLAMINE TRIETHIODIDE
INJECTABLE; INJECTION FLAXEDIL DAVIS AND GECK

20MG/ML 100MG/ML

N007842 N007842

001 002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

GALLIUM CITRATE GA-67
INJECTABLE; INJECTION GALLIUM CITRATE GA 67 GE HEALTHCARE NEOSCAN GE HEALTHCARE

6 - 151 (of 346)

1mCi/ML 2mCi/ML

N017700 N017655

001 001

GANCICLOVIR
CAPSULE; ORAL CYTOVENE ROCHE PALO

250MG 500MG

N020460 N020460

001 002

Dec 22, 1994 Dec 12, 1997

GANCICLOVIR SODIUM
INJECTABLE; INJECTION GANCICLOVIR SODIUM BEDFORD

EQ 500MG BASE/VIAL

A076222

001

Jul 16, 2003

GEFITINIB
TABLET; ORAL IRESSA ASTRAZENECA

250MG

N021399

001

May 05, 2003

GEMFIBROZIL
CAPSULE; ORAL GEMFIBROZIL MYLAN PUREPAC PHARM LOPID PFIZER PHARMS TABLET; ORAL GEMFIBROZIL MYLAN PUREPAC PHARM SANDOZ WATSON LABS

300MG 300MG 200MG 300MG

A073466 A072929 N018422 N018422

001 001 001 002

Jan 25, 1993 Jan 29, 1993

600MG 600MG 600MG 600MG

A074452 A074360 A074615 A074156

001 001 001 001

Feb Aug Sep Oct

16, 31, 29, 24,

1995 1994 1995 1994

GEMTUZUMAB OZOGAMICIN
INJECTABLE; INJECTION MYLOTARG WYETH PHARMS INC

5MG/VIAL

N021174

001

May 17, 2000

GENTAMICIN SULFATE
CREAM; TOPICAL GARAMYCIN SCHERING GENTAFAIR PHARMAFAIR GENTAMICIN SULFATE ALPHARMA US PHARMS BAUSCH AND LOMB PHARMADERM INJECTABLE; INJECTION APOGEN KING PHARMS BRISTAGEN
BRISTOL
GARAMYCIN
SCHERING

EQ 0.1% BASE EQ 0.1% BASE EQ 0.1% BASE EQ 0.1% BASE EQ 1MG BASE/GM

A060462 A062458 A062471 A064056 A062530

001 001 001 001 001 Sep 01, 1983 Sep 27, 1983 Apr 29, 1994 Jul 05, 1984

EQ 10MG BASE/ML EQ 40MG BASE/ML EQ 40MG BASE/ML EQ 1MG BASE/ML EQ 10MG BASE/ML EQ 40MG BASE/ML

A062289 A062289 A062288 A061716 A061739 A061716

001 002 001 002 001 001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

GENTAMICIN SULFATE
INJECTABLE; INJECTION GENTAFAIR PHARMAFAIR GENTAMICIN INTL MEDICATION

6 - 152 (of 346)

EQ 40MG BASE/ML EQ 1MG BASE/ML EQ 40MG BASE/ML EQ 100MG BASE/100ML

A062493 A062325 A062325 A062325 A062413 A062413 A062413 A062413 A062413 A062413 A062413 A062413 A062413 A062413 A062251 A062251 A062354 A062340 A062507 A062507 A063149 A063106 A062318 A062318 A062264 A062264 A062588 A062588 A062588 A062588 A062588 A062588 A062588 A062588 A062588 A062588 A062248 A062248

001 003 001 004 001 002 003 004 005 006 007 008 009 010 002 001 001 001 001 002 001 002 002 001 001 002 001 002 003 004 005 006 007 008 009 010 001 002

Aug 28, 1985 Jun 23, 1982 Jun 23, 1982 Aug Aug Aug Aug Aug Aug Aug Aug Aug Aug 11, 11, 11, 11, 11, 11, 11, 11, 11, 11, 1983 1983 1983 1983 1983 1983 1983 1983 1983 1983

EQ 1.2MG BASE/ML EQ 1.4MG BASE/ML EQ 1.6MG BASE/ML EQ 1.8MG BASE/ML EQ 2MG BASE/ML EQ 60MG BASE/100ML EQ 70MG BASE/100ML EQ 80MG BASE/100ML EQ 90MG BASE/100ML EQ 100MG BASE/100ML BAXTER HLTHCARE EQ 10MG BASE/ML EQ 40MG BASE/ML KALAPHARM EQ 40MG BASE/ML PHARM SPEC EQ 40MG BASE/ML SOLOPAK EQ 10MG BASE/ML EQ 40MG BASE/ML TEVA PARENTERAL EQ 10MG BASE/ML EQ 40MG BASE/ML WATSON LABS EQ 10MG BASE/ML EQ 40MG BASE/ML WYETH AYERST EQ 10MG BASE/ML EQ 40MG BASE/ML GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HOSPIRA EQ 1.2MG BASE/ML EQ 1.4MG BASE/ML EQ 1.6MG BASE/ML EQ 1.8MG BASE/ML EQ 2MG BASE/ML EQ 60MG BASE/100ML EQ 70MG BASE/100ML EQ 80MG BASE/100ML EQ 90MG BASE/100ML EQ 100MG BASE/100ML U-GENCIN PHARMACIA AND UPJOHN EQ 10MG BASE/ML EQ 40MG BASE/ML INJECTABLE; INTRATHECAL GARAMYCIN SCHERING EQ 2MG BASE/ML OINTMENT; OPHTHALMIC GARAMYCIN SCHERING EQ 0.3% BASE GENTACIDIN NOVARTIS EQ 0.3% BASE GENTAFAIR PHARMAFAIR EQ 3MG BASE/GM OINTMENT; TOPICAL GARAMYCIN SCHERING EQ 0.1% BASE GENTAFAIR PHARMAFAIR EQ 0.1% BASE GENTAMICIN SULFATE ALPHARMA US PHARMS EQ 0.1% BASE BAUSCH AND LOMB EQ 0.1% BASE PHARMADERM EQ 0.1% BASE

GENTAMICIN SULFATE ABBOTT

Apr Mar Jun Jun Nov Nov

05, 28, 06, 06, 21, 21,

1982 1983 1985 1985 1991 1991

Jan Jan Jan Jan Jan Jan Jan Jan Jan Jan

06, 06, 06, 06, 06, 06, 06, 06, 06, 06,

1986 1986 1986 1986 1986 1986 1986 1986 1986 1986

N050505

001

N050425 A062501 A062443

001 001 001 Jul 26, 1984 May 26, 1983

A060463 A062444 A062496 A064054 A062534

001 001 001 001 001 May 26, 1983 Mar 14, 1984 Apr 29, 1994 Oct 10, 1984

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

GENTAMICIN SULFATE
SOLUTION/DROPS; OPHTHALMIC GARAMYCIN SCHERING EQ GENTACIDIN NOVARTIS EQ GENTAFAIR PHARMAFAIR EQ GENTAMICIN SULFATE ALCON UNIVERSAL EQ PACO EQ

6 - 153 (of 346)

0.3% BASE 0.3% BASE 0.3% BASE 0.3% BASE 3MG BASE/ML

N050039 A062480 A062440 A062523 A062932

002 001 001 001 001 Mar 30, 1984 May 03, 1983 Nov 25, 1985 Nov 07, 1988

GENTIAN VIOLET
SUPPOSITORY; VAGINAL GVS SAVAGE LABS TAMPON; VAGINAL GENAPAX KEY PHARMS

0.4%

A083513

001

5MG

A085017

001

GLATIRAMER ACETATE
FOR SOLUTION; SUBCUTANEOUS COPAXONE TEVA 20MG/VIAL

N020622

001

Dec 20, 1996

GLIMEPIRIDE
TABLET; ORAL GLIMEPIRIDE RANBAXY

3MG 6MG

A077366 A077366

001 002

Oct 06, 2005 Oct 06, 2005

GLIPIZIDE
TABLET; ORAL GLIPIZIDE ENDO PHARMS PLIVA SANDOZ TEVA GLUCOTROL PFIZER

5MG 10MG 5MG 10MG 5MG 10MG 5MG 10MG 2.5MG

A074378 A074378 A074619 A074619 A074542 A074542 A074387 A074387 N017783

001 002 001 002 001 002 001 002 003

Nov Nov Apr Apr Jun Jun Mar Mar

28, 28, 04, 04, 20, 20, 04, 04,

1994 1994 1997 1997 1995 1995 1996 1996

May 11, 1993

GLIPIZIDE; METFORMIN HYDROCHLORIDE

TABLET; ORAL METAGLIP BRISTOL MYERS SQUIBB

2.5MG;250MG 2.5MG;500MG 5MG;500MG

N021460 N021460 N021460

001 002 003

Oct 21, 2002 Oct 21, 2002 Oct 21, 2002

GLUCAGON HYDROCHLORIDE
INJECTABLE; INJECTION GLUCAGON LILLY

EQ 1MG BASE/VIAL EQ 10MG BASE/VIAL

N012122 N012122

001 002

GLUTETHIMIDE
CAPSULE; ORAL DORIDEN SANOFI AVENTIS US

500MG

N009519

008

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

GLUTETHIMIDE
TABLET; ORAL DORIDEN SANOFI AVENTIS US GLUTETHIMIDE HALSEY LANNETT SANDOZ UCB INC VITARINE WATSON LABS

6 - 154 (of 346)

250MG 500MG 250MG 500MG 250MG 500MG 500MG 500MG 500MG 500MG 500MG

N009519 N009519 A089458 A089459 A083475 A085571 A083234 A085171 A087297 A084362 A085763

002 005 001 001 001 001 002 001 001 001 001 Oct 10, 1986 Oct 10, 1986

GLYBURIDE
TABLET; ORAL GLYBURIDE ACTAVIS TOTOWA

1.5MG 3MG 6MG 1.5MG 3MG 1.5MG 3MG 6MG 4.5MG 1.25MG 2.5MG 5MG

A075947 A075947 A075947 A075174 A075174 N020055 N020055 N020055 N020051 N017498 N017498 N017498

001 002 003 001 002 001 002 003 003 001 002 003

Nov 14, 2002 Nov 14, 2002 Nov 14, 2002 Jun Jun Apr Apr Mar 22, 22, 17, 17, 08, 1998 1998 1992 1992 2000

GLYBURIDE (MICRONIZED) SANDOZ SANOFI AVENTIS US

GLYNASE PHARMACIA AND UPJOHN MICRONASE PHARMACIA AND UPJOHN

Sep 24, 1993 May 01, 1984 May 01, 1984 May 01, 1984

GLYBURIDE; METFORMIN HYDROCHLORIDE

TABLET; ORAL GLYBURIDE AND METFORMIN HYDROCHLORIDE TEVA 1.25MG;250MG 2.5MG;500MG 5MG;500MG

A076821 A076821 A076821

001 002 003

Jan 27, 2005 Jan 27, 2005 Jan 27, 2005

GLYCINE
SOLUTION; IRRIGATION GLYCINE 1.5% IN PLASTIC CONTAINER BAXTER HLTHCARE 1.5GM/100ML HOSPIRA 1.5GM/100ML

N018522 N017633

001 001

Feb 19, 1982

GLYCOPYRROLATE
INJECTABLE; INJECTION GLYCOPYRROLATE ABRAXIS PHARM HOSPIRA TEVA PARENTERAL WATSON LABS ROBINUL ROBINS AH TABLET; ORAL GLYCOPYRROLATE WATSON LABS

0.2MG/ML 0.2MG/ML 0.2MG/ML 0.2MG/ML 0.2MG/ML

A088475 A089393 A081169 A086947 N014764

001 001 001 001 001

Jun Jun Sep Jun

12, 15, 10, 24,

1984 1988 1991 1983

1MG 1MG 2MG 2MG

A085562 A086902 A085563 A086178

001 001 001 001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

GLYCOPYRROLATE
TABLET; ORAL

GLYCOPYRROLATE

WATSON LABS

6 - 155 (of 346)

2MG

A086900

001

GONADORELIN ACETATE
INJECTABLE; INJECTION LUTREPULSE KIT FERRING

0.8MG/VIAL 3.2MG/VIAL

N019687 N019687

001 002

Oct 10, 1989 Oct 10, 1989

GONADORELIN HYDROCHLORIDE

INJECTABLE; INJECTION

FACTREL
HIKMA (MAPLE)

EQ 0.1MG BASE/VIAL EQ 0.2MG BASE/VIAL EQ 0.5MG BASE/VIAL

N018123 N018123 N018123

001 002 003

Sep 30, 1982 Sep 30, 1982 Sep 30, 1982

GONADOTROPIN, CHORIONIC
INJECTABLE; INJECTION A.P.L. FERRING

5,000 UNITS/VIAL 10,000 UNITS/VIAL 20,000 UNITS/VIAL 5,000 UNITS/VIAL 15,000 UNITS/VIAL 20,000 UNITS/VIAL 5,000 UNITS/VIAL 10,000 UNITS/VIAL 2,000 UNITS/VIAL 2,000 UNITS/VIAL 5,000 UNITS/VIAL 15,000 UNITS/VIAL 20,000 UNITS/VIAL 10,000 UNITS/VIAL

N017055 N017055 N017055 N017067 N017067 N017067 N017054 N017054 N017016 N017016 N017016 N017016 N017016 N017056

001

002

003

001

004

003

001

002
009 011 006 010 004
001

CHORIONIC GONADOTROPIN APP PHARMS

BEL MAR FERRING

Dec 27, 1984 Feb 16, 1990 Feb 15, 1985

FOLLUTEIN
BRISTOL MYERS SQUIBB

GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

SOLUTION/DROPS; OPHTHALMIC NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN IPHARM 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML WATSON LABS 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML NEOMYCIN SULFATE AND POLYMYXIN B SULFATE GRAMICIDIN PHARMAFAIR 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML NEO-POLYCIN DOW PHARM 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML

A062818 A062788

001 001

Oct 11, 1988 Jun 11, 1987

A062383

001

Aug 31, 1982

A060427

001

GRANISETRON HYDROCHLORIDE
INJECTABLE; INJECTION
KYTRIL
ROCHE

EQ EQ EQ EQ

0.1MG BASE/ML (EQ 0.1MG BASE/ML) 1MG BASE/ML (EQ 1MG BASE/ML) 3MG BASE/ML 4MG BASE/4ML (EQ 1MG BASE/ML)

N020239 N020239 N020239 N020239

003 004 001 002

Sep Mar Dec Mar

17, 11, 29, 11,

2004 1994 1993 1994

SOLUTION; ORAL KYTRIL ROCHE

EQ 2MG BASE/10ML

N021238

001

Jun 27, 2001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

GRANISETRON HYDROCHLORIDE
TABLET; ORAL GRANISETRON HYDROCHLORIDE BARR EQ 1MG BASE KYTRIL ROCHE EQ 1MG BASE EQ 2MG BASE

6 - 156 (of 346)

A078221 N020305 N020305

001 001 002

Dec 31, 2007 Mar 16, 1995 Jun 15, 1998

GREPAFLOXACIN HYDROCHLORIDE
TABLET; ORAL RAXAR OTSUKA

EQ 200MG BASE EQ 400MG BASE EQ 600MG BASE

N020695 N020695 N020695

001 002 003

Nov 06, 1997 May 14, 1998 May 14, 1998

GRISEOFULVIN, MICROCRYSTALLINE
CAPSULE; ORAL GRISACTIN WYETH AYERST SUSPENSION; ORAL GRIFULVIN V JOHNSON AND JOHNSON TABLET; ORAL FULVICIN-U/F ELORAC GRIFULVIN V J AND J

125MG 250MG

N050051 N050051

002 001

125MG/5ML

N050448

001

250MG 500MG 125MG 250MG 500MG 125MG 250MG 500MG

A060569 A060569 A060618 A060618 A060618 A062279 A062279 A060212

002 001 001 002 003 001 002 001

ORTHONEUTROGENA GRISACTIN WYETH AYERST

GRISEOFULVIN, ULTRAMICROCRYSTALLINE
TABLET; ORAL FULVICIN P/G ELORAC FULVICIN P/G 165 ELORAC FULVICIN P/G 330 ELORAC GRISACTIN ULTRA WYETH AYERST

125MG 250MG 165MG 330MG 125MG 165MG 250MG 330MG 165MG 330MG

A061996 A061996 A061996 A061996 A062178 A062438 A062178 A062438 A062645 A062646

001 002 003 004 001 001 002 002 001 001 Apr 06, 1982 Apr 06, 1982

Nov 17, 1983 Nov 17, 1983 Jun 30, 1992 Jun 30, 1992

ULTRAGRIS-165 PLIVA ULTRAGRIS-330 PLIVA

GUANABENZ ACETATE
TABLET; ORAL GUANABENZ ACETATE SANDOZ TEVA PHARMS WATSON LABS

EQ EQ EQ EQ EQ

4MG 8MG 4MG 8MG 4MG

BASE BASE BASE BASE BASE

A074517 A074517 A074267 A074267 A074025

001 002 001 002 001

Sep Sep Jun Jun Feb

30, 30, 01, 01, 28,

1998 1998 1994 1994 1994

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

GUANABENZ ACETATE
TABLET; ORAL GUANABENZ ACETATE WATSON LABS WYTENSIN WYETH AYERST

6 - 157 (of 346)

EQ 8MG BASE EQ 4MG BASE EQ 8MG BASE EQ 16MG BASE

A074025 N018587 N018587 N018587

002 001 002 003

Feb 28, 1994 Sep 07, 1982 Sep 07, 1982 Sep 07, 1982

GUANADREL SULFATE
TABLET; ORAL HYLOREL PHARMACIA AND UPJOHN

10MG 25MG

N018104 N018104

001 002

Dec 29, 1982 Dec 29, 1982

GUANETHIDINE MONOSULFATE
TABLET; ORAL GUANETHIDINE MONOSULFATE WATSON LABS EQ EQ ISMELIN NOVARTIS EQ EQ

10MG SULFATE 25MG SULFATE 10MG SULFATE 25MG SULFATE

A086113 A086114 N012329 N012329

001 001 001 002

Mar 26, 1985 Mar 26, 1985

GUANETHIDINE MONOSULFATE; HYDROCHLOROTHIAZIDE

TABLET; ORAL ESIMIL NOVARTIS

10MG;25MG

N013553

001

GUANFACINE HYDROCHLORIDE
TABLET; ORAL GUANFACINE HYDROCHLORIDE WATSON LABS EQ 1MG BASE EQ 2MG BASE TENEX PROMIUS PHARMA EQ 3MG BASE

A074762 A074762 N019032

001 002 003

Jun 25, 1997 Jun 25, 1997 Nov 07, 1988

HALAZEPAM
TABLET; ORAL PAXIPAM SCHERING

20MG 40MG

N017736 N017736

003 004

HALCINONIDE
CREAM; TOPICAL HALOG WESTWOOD SQUIBB HALOG-E RANBAXY OINTMENT; TOPICAL HALOG BRISTOL MYERS SQUIBB SOLUTION; TOPICAL HALOG RANBAXY

0.025% 0.1%

N017818 N018234

001 001

0.025%

N018125

001

0.1%

N017823

001

HALOBETASOL PROPIONATE
OINTMENT; TOPICAL HALOBETASOL PROPIONATE ACTAVIS MID ATLANTIC

0.05%

A077109

001

Jun 14, 2005

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

HALOFANTRINE HYDROCHLORIDE
TABLET; ORAL HALFAN GLAXOSMITHKLINE

6 - 158 (of 346)

250MG

N020250

001

Jul 24, 1992

HALOPERIDOL
TABLET; ORAL HALDOL ORTHO MCNEIL

0.5MG 1MG 2MG 5MG 10MG 20MG 1MG 0.5MG 1MG 2MG 5MG 10MG 20MG 0.5MG 1MG 2MG 5MG 10MG 20MG 0.5MG 1MG 2MG 5MG 10MG 20MG 20MG 0.5MG 1MG 2MG 5MG 10MG 20MG 0.5MG 1MG 2MG 5MG 0.5MG 1MG 2MG 5MG 10MG 20MG 0.5MG 1MG 2MG 5MG 10MG 20MG 0.5MG 1MG 2MG 5MG 10MG

N015921 N015921 N015921 N015921 N015921 N015921 N017079 A071216 A071217 A071218 A071219 A071220 A071221 A072727 A072728 A072729 A072730 A072731 A072732 A071156 A071157 A071172 A071212 A071173 A071177 A071328 A071071 A071072 A071073 A071074 A071075 A071076 A071255 A071269 A071256 A071257 A071128 A071129 A071130 A071131 A071132 A071133 A071722 A071723 A071724 A071725 A072121 A072122 A070720 A070721 A070722 A070723 A070724

001 002 003 004 005 006 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001

Feb 02, 1982

HALDOL SOLUTAB ORTHO MCNEIL PHARM HALOPERIDOL DURAMED PHARMS BARR

LEDERLE

MUTUAL PHARM

PAR PHARM PUREPAC PHARM

QUANTUM PHARMICS

ROXANE

ROYCE LABS

SCS

Dec Dec Dec Dec Jul Jul Sep Sep Sep Sep Sep Sep Jan Jan Jan Jan Jan Jan Jul Nov Nov Nov Nov Aug Aug Feb Feb Feb Feb Feb Feb Feb Feb May May Dec Dec Dec Dec Dec Dec Jun Jun Jun Jun Jun

04, 04, 04, 04, 07, 07, 19, 19, 19, 19, 19, 19, 02, 02, 02, 07, 07, 07, 20, 03, 03, 03, 03, 04, 04, 17, 17, 17, 17, 17, 17, 17, 17, 12, 12, 24, 24, 24, 24, 24, 24, 10, 10, 10, 10, 10,

1986 1986 1986 1986 1987 1987 1989 1989 1989 1989 1989 1989 1987 1987 1987 1988 1988 1988 1987 1986 1986 1986 1986 1987 1987 1987 1987 1987 1987 1987 1987 1987 1987 1987 1987 1987 1987 1987 1987 1987 1987 1986 1986 1986 1986 1986

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

HALOPERIDOL
TABLET; ORAL HALOPERIDOL SCS VINTAGE

6 - 159 (of 346)

WATSON LABS

20MG 0.5MG 1MG 2MG 5MG 10MG 0.5MG 0.5MG 1MG 1MG 2MG 2MG 5MG 5MG 10MG 10MG 20MG 20MG

A070725 A071233 A071234 A071235 A071236 A071237 A070981 A071571 A070982 A071572 A070983 A071573 A070984 A071374 A071375 A072113 A071376 A072353

001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001

Sep Nov Nov Nov Nov Jul Mar Jun Mar Jun Mar Jun Mar Jun Jun Aug Jun Aug

24, 03, 03, 03, 03, 20, 06, 03, 06, 03, 06, 03, 06, 03, 03, 27, 03, 27,

1986 1986 1986 1986 1986 1987 1987 1988 1987 1988 1987 1988 1987 1988 1988 1991 1988 1991

HALOPERIDOL DECANOATE
INJECTABLE; INJECTION HALOPERIDOL DECANOATE HOSPIRA SANDOZ

EQ EQ EQ EQ

50MG BASE/ML 100MG BASE/ML 50MG BASE/ML 100MG BASE/ML

A075176 A075176 A076463 A076463

001 002 001 002

Feb Feb Jun Jun

09, 09, 24, 24,

2000 2000 2005 2005

HALOPERIDOL LACTATE
CONCENTRATE; ORAL HALDOL ORTHO MCNEIL HALOPERIDOL ALPHARMA MORTON GROVE SCS TEVA HALOPERIDOL INTENSOL ROXANE INJECTABLE; INJECTION HALOPERIDOL ABRAXIS PHARM MARSAM PHARMS LLC SANDOZ SMITH AND NEPHEW SOLOPAK

EQ 2MG BASE/ML EQ EQ EQ EQ 2MG 2MG 2MG 2MG BASE/ML BASE/ML BASE/ML BASE/ML

N015922 A070318 A070710 A070726 A071015 A072045

001 001 001 001 001 001 Apr Mar Jun Aug 11, 07, 10, 25, 1986 1986 1986 1987

EQ 2MG BASE/ML

Apr 12, 1988

WATSON LABS

EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ

5MG 5MG 5MG 5MG 5MG 5MG 5MG 5MG 5MG 5MG 5MG

BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML

A071187 A072516 A072517 A076464 A070802 A070800 A070801 A070864 A070713 A070714 A070744

001 001 001 001 001 001 001 001 001 001 001

Jan Feb Feb Sep Dec Dec Dec Dec May May May

20, 25, 25, 29, 14, 14, 14, 14, 17, 17, 17,

1987 1993 1993 2004 1987 1987 1987 1987 1988 1988 1988

SOLUTION; ORAL HALOPERIDOL LACTATE ACTAVIS MID ATLANTIC

EQ 1MG BASE/ML

A074536

001

Nov 02, 1995

HALOPROGIN
CREAM; TOPICAL HALOTEX WESTWOOD SQUIBB

1%

N016942

001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

HALOPROGIN
SOLUTION; TOPICAL HALOTEX WESTWOOD SQUIBB

6 - 160 (of 346)

1%

N016943

001

HALOTHANE
LIQUID; INHALATION FLUOTHANE WYETH AYERST HALOTHANE BH HALOCARBON HOSPIRA

99.99% 99.99% 99.99% 99.99%

N011338 A084977 A080810 A083254

001 001 001 001

HEPARIN CALCIUM
INJECTABLE; INJECTION CALCIPARINE SANOFI AVENTIS US

25,000 UNITS/ML

N018237

001

HEPARIN SODIUM
INJECTABLE; INJECTION HEPARIN LOCK FLUSH HOSPIRA INTL MEDICATION LUITPOLD PARKE DAVIS SMITH AND NEPHEW

SOLOPAK

100 UNITS/ML 10 UNITS/ML 500 UNITS/ML 10 UNITS/ML 100 UNITS/ML 10 UNITS/ML 10 UNITS/ML 10 UNITS/ML 10 UNITS/ML 10 UNITS/ML 100 UNITS/ML 100 UNITS/ML 100 UNITS/ML 100 UNITS/ML 10 UNITS/ML 10 UNITS/ML 100 UNITS/ML 100 UNITS/ML 1,000 UNITS/ML 1,000 UNITS/ML 5,000 UNITS/ML 10,000 UNITS/ML 1,000 UNITS/ML 5,000 UNITS/ML 10,000 UNITS/ML 20,000 UNITS/ML 40,000 UNITS/ML 1,000 UNITS/ML 5,000 UNITS/ML 10,000 UNITS/ML 20,000 UNITS/ML 5,000 UNITS/0.5ML 1,000 UNITS/ML 2,500 UNITS/ML 5,000 UNITS/ML 5,000 UNITS/0.5ML 7,500 UNITS/ML 10,000 UNITS/ML 15,000 UNITS/ML 20,000 UNITS/ML

N005264 A086357 A086357 A089063 A089064 N017346 A087904 A087958 A088458 A088580 A087906 A087959 A088460 A088581 A087903 A088457 A087905 A088459 N017033 N017979 N017979 N017979 N017486 N017486 N017486 N017486 N017486 N017651 N017029 N017651 N017651 N017037 N017007 N017007 N017007 N017007 N017007 N017007 N017007 N017007

010 001 002 001 001 006 001 001 001 001 001 001 001 001 001 001 001 001 001 001 003 002 001 002 003 004 005 005 002 003 008 013 001 007 002 010 003 004 005 006

Oct 09, 1985 Oct 09, 1985 Apr Apr Jul Oct Apr Apr Jul Oct Apr Oct Apr Jul 20, 20, 26, 25, 20, 20, 26, 25, 20, 25, 20, 26, 1983 1983 1984 1984 1983 1983 1984 1984 1983 1984 1983 1984

HEPARIN SODIUM ABRAXIS PHARM

AKORN

APP PHARMS

BAXTER HLTHCARE BAXTER HLTHCARE CORP

Apr 07, 1986

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

HEPARIN SODIUM
INJECTABLE; INJECTION HEPARIN SODIUM CHAMBERLIN PARENTERL

6 - 161 (of 346)

1,000 UNITS/ML N017130 5,000 UNITS/ML N017130 10,000 UNITS/ML N017130 20,000 UNITS/ML N017130 DELL LABS 1,000 UNITS/ML N017540 5,000 UNITS/ML N017540 10,000 UNITS/ML N017540 20,000 UNITS/ML N017540 40,000 UNITS/ML N017540 HOSPIRA 2,500 UNITS/ML A088099 10,000 UNITS/ML A040095 LILLY 1,000 UNITS/ML N005521 10,000 UNITS/ML N005521 20,000 UNITS/ML N005521 LUITPOLD 1,000 UNITS/ML A087452 MARSAM PHARMS LLC 1,000 UNITS/ML A040007 1,000 UNITS/ML A040008 ORGANON USA INC 1,000 UNITS/ML N000552 5,000 UNITS/ML N000552 10,000 UNITS/ML N000552 PARKE DAVIS 1,000 UNITS/ML N017346 5,000 UNITS/ML N017346 7,500 UNITS/ML N017346 10,000 UNITS/ML N017346 20,000 UNITS/ML N017346 PHARM SPEC 1,000 UNITS/ML N017780 5,000 UNITS/ML N017780 10,000 UNITS/ML N017780 20,000 UNITS/ML N017780 40,000 UNITS/ML N017780 PHARMACIA AND UPJOHN 1,000 UNITS/ML N004570 5,000 UNITS/ML N004570 10,000 UNITS/ML N004570 SMITH AND NEPHEW 1,000 UNITS/ML A088239 SOLOPAK 1,000 UNITS/ML A087043 5,000 UNITS/ML A087077 5,000 UNITS/0.5ML A087395 10,000 UNITS/ML A087107 10,000 UNITS/0.5ML A087363 WATSON LABS 1,000 UNITS/ML N017064 2,500 UNITS/ML N017064 3,000 UNITS/ML N017064 4,000 UNITS/ML N017064 5,000 UNITS/ML N017064 6,000 UNITS/ML N017064 7,500 UNITS/ML N017064 10,000 UNITS/ML N017064 20,000 UNITS/ML N017064 40,000 UNITS/ML N017064 HEPARIN SODIUM 1,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER MCGAW 200 UNITS/100ML N019130 HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER B BRAUN 200 UNITS/100ML N019042 HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% HOSPIRA 10,000 UNITS/100ML N018911 HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER BAXTER HLTHCARE 2,000 UNITS/100ML N018814 HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.45% HOSPIRA 10,000 UNITS/100ML N018911 10,000 UNITS/100ML N018916

001 002 003 004 001 002 003 004 005 001 001 001 002 004 001 001 001 008 009 010 001 002 003 004 005 001 002 003 004 005 001 002 003 001 001 001 001 001 001 002 015 016 017 003 018 019 004 005 006 001 001 006 002 001 005

Apr 28, 1983 Jul 26, 1996

Oct 31, 1983 Jun 07, 1996 Oct 10, 1995

Jul 26, 1984

Dec 31, 1984 Mar 29, 1985 Jan 30, 1985 Jul 09, 1985 Jan 30, 1985 Jan 31, 1984

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

HEPARIN SODIUM
INJECTABLE; INJECTION HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.9% HOSPIRA 10,000 UNITS/100ML N018911 10,000 UNITS/100ML N018916 HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% HOSPIRA 5,000 UNITS/100ML N018911 HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER B BRAUN 5,000 UNITS/100ML N019802 HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.9% HOSPIRA 5,000 UNITS/100ML N018911 5,000 UNITS/100ML N018916 HEPARIN SODIUM 2,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER MCGAW 200 UNITS/100ML N019130 HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER B BRAUN 200 UNITS/100ML N019042 HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% HOSPIRA 5,000 UNITS/100ML N018911 10,000 UNITS/100ML N018911 HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER B BRAUN 5,000 UNITS/100ML N019134 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER B BRAUN 5,000 UNITS/100ML N019802 10,000 UNITS/100ML N019802 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% HOSPIRA 5,000 UNITS/100ML N018911 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER B BRAUN 5,000 UNITS/100ML N019135 5,000 UNITS/100ML N019802 HOSPIRA 5,000 UNITS/100ML N018916 HEPARIN SODIUM 5,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER BAXTER HLTHCARE 500 UNITS/100ML N018609 HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER MCGAW 1,000 UNITS/100ML N019130 HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.45% HOSPIRA 100 UNITS/ML N018911 100 UNITS/ML N018916 HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% HOSPIRA 1,000 UNITS/100ML N018916 HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER B BRAUN 1,000 UNITS/100ML N019042 HEPARIN SODIUM PRESERVATIVE FREE HOSPIRA 2,000 UNITS/ML N005264 2,500 UNITS/ML N005264 MARSAM PHARMS LLC 1,000 UNITS/ML A089464 PHARMA SERVE NY 1,000 UNITS/ML A086129 LIPO-HEPIN 3M 1,000 UNITS/0.5ML N017027 1,000 UNITS/ML N017027 5,000 UNITS/0.5ML N017027 5,000 UNITS/ML N017027 7,500 UNITS/0.5ML N017027 10,000 UNITS/0.5ML N017027 10,000 UNITS/ML N017027 15,000 UNITS/0.5ML N017027 20,000 UNITS/0.5ML N017027 20,000 UNITS/ML N017027 40,000 UNITS/ML N017027 LIQUAEMIN LOCK FLUSH ORGANON USA INC 100 UNITS/ML N000552 LIQUAEMIN SODIUM ORGANON USA INC 1,000 UNITS/ML N000552 5,000 UNITS/ML N000552

6 - 162 (of 346)

003 002 007 001 005 003 003 002 009 008 001 005 002 004 001 003 009 003 002 002 004 001 004 013 014 001 001 001 006 002 008 010 003 009 011 004 007 005 007 004 003

Jan 30, 1985 Jan 31, 1984 Jan 30, 1985 Jul 20, 1992 Jan 30, 1985 Jan 31, 1984 Dec 31, 1984 Mar 29, 1985 Jan 30, 1985 Jan 30, 1985 Mar 29, 1985 Jul 20, 1992 Jul 20, 1992 Jan 30, 1985 Mar 29, 1985 Jul 20, 1992 Jan 31, 1984 Apr 28, 1982 Dec 31, 1984 Jan 30, 1985 Jan 31, 1984 Jan 31, 1984 Mar 29, 1985 Apr 07, 1986 Apr 07, 1986 Jun 03, 1986

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

HEPARIN SODIUM
INJECTABLE; INJECTION LIQUAEMIN SODIUM ORGANON USA INC

6 - 163 (of 346)

10,000 UNITS/ML 20,000 UNITS/ML 40,000 UNITS/ML LIQUAEMIN SODIUM PRESERVATIVE FREE ORGANON USA INC 1,000 UNITS/ML 5,000 UNITS/ML 10,000 UNITS/ML PANHEPRIN
HOSPIRA
1,000 UNITS/ML 5,000 UNITS/ML 10,000 UNITS/ML 20,000 UNITS/ML 40,000 UNITS/ML SODIUM HEPARIN ABRAXIS PHARM 5,000 UNITS/ML 10,000 UNITS/ML 20,000 UNITS/ML BAXTER HLTHCARE 1,000 UNITS/ML

N000552 N000552 N000552 N000552 N000552 N000552 N005264 N005264 N005264 N005264 N005264 N017033 N017033 N017033 N017036

005 001 002 011 012 013 004 006 007 008 009 002 003 004 001 Apr 11, 1986 Apr 11, 1986 Apr 11, 1986

Mar 04, 1988

HETACILLIN
FOR SUSPENSION; ORAL VERSAPEN BRISTOL

EQ EQ EQ EQ

112.5MG AMPICIL/ML 112.5MG AMPICIL/5ML 112.5MG AMPICIL/ML 225MG AMPICIL/5ML

A061398 N050060 N050060 A061398

001 001 003 002

HETACILLIN POTASSIUM
CAPSULE; ORAL VERSAPEN-K BRISTOL

EQ 225MG AMPICIL EQ 450MG AMPICIL

A061396 A061396

001 002

HEXACHLOROPHENE
AEROSOL; TOPICAL SEPTISOL VESTAL LABS TURGEX XTTRIUM EMULSION; TOPICAL HEXA-GERM HUNTINGTON LABS PHISOHEX SANOFI AVENTIS US SOY-DOME BAYER PHARMS TURGEX XTTRIUM SOAP; TOPICAL GAMOPHEN ARBROOK SOLUTION; TOPICAL DIAL DIAL GERMA-MEDICA HUNTINGTON LABS GERMA-MEDICA "MG" HUNTINGTON LABS SEPTI-SOFT CALGON

0.23% 3%

N017424 N018375

001 001

3% 3% 3% 3%

N017411 N008402 N017405 N019055

001 001 001 001 Nov 30, 1984

2%

N006270

003

0.25% 1% 0.25% 0.25%

N017421 N017412 N017412 N017460

002 001 002 001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

HEXACHLOROPHENE
SOLUTION; TOPICAL SEPTISOL VESTAL LABS 0.25% SPONGE; TOPICAL E-Z SCRUB BECTON DICKINSON 450MG HEXASCRUB PROF DSPLS 3% PHISO-SCRUB SANOFI AVENTIS US 3% SCRUBTEAM SURGICAL SPONGEBRUSH 3M 330MG

6 - 164 (of 346)

N017423

001

N017452 N018363 N017446 N017413

001 001 001 001

HEXAFLUORENIUM BROMIDE
INJECTABLE; INJECTION MYLAXEN MEDPOINTE PHARM HLC

20MG/ML

N009789

003

HEXOCYCLIUM METHYLSULFATE
TABLET; ORAL TRAL ABBOTT

25MG

N010599

001

HEXYLCAINE HYDROCHLORIDE
SOLUTION; TOPICAL CYCLAINE MERCK

5%

N008472

001

HISTAMINE PHOSPHATE
INJECTABLE; INJECTION HISTAMINE PHOSPHATE LILLY

EQ 0.1MG BASE/ML EQ 0.2MG BASE/ML EQ 1MG BASE/ML

N000734 N000734 N000734

003 002 001

HISTRELIN ACETATE
INJECTABLE; INJECTION SUPPRELIN SHIRE

EQ 0.2MG BASE/ML EQ 0.5MG BASE/ML EQ 1MG BASE/ML

N019836 N019836 N019836

001 002 003

Dec 24, 1991 Dec 24, 1991 Dec 24, 1991

HOMATROPINE METHYLBROMIDE
TABLET; ORAL HOMAPIN-10 MISSION PHARMA HOMAPIN-5 MISSION PHARMA TABLET, CHEWABLE; ORAL EQUIPIN MISSION PHARMA

10MG 5MG

A086308 A086309

001 001

3MG

A086310

001

HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE

SYRUP; ORAL HYCODAN ENDO PHARMS 1.5MG/5ML;5MG/5ML HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE IVAX SUB TEVA PHARMS 1.5MG/5ML;5MG/5ML HYDROPANE HALSEY 1.5MG/5ML;5MG/5ML

N005213 A040285 A088066

002 001 001

Jul 26, 1988 Jul 19, 1999 Jun 28, 1985

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE
TABLET; ORAL HOMATROPRINE METHYLBROMIDE AND HYDROCODONE BITARTRATE ACTAVIS TOTOWA 1.5MG;5MG HYCODAN ENDO PHARMS 1.5MG;5MG

6 - 165 (of 346)

A040295 N005213

001 001

Dec 01, 2000 Jul 26, 1988

HYALURONIDASE
INJECTABLE; INJECTION VITRASE ISTA PHARMS WYDASE BAXTER HLTHCARE

6,200 UNITS/VIAL 150 UNITS/ML 150 UNITS/VIAL 1,500 UNITS/VIAL

N021640 N006343 N006343 N006343

001 002 006 005

May 05, 2004

HYDRALAZINE HYDROCHLORIDE
INJECTABLE; INJECTION APRESOLINE NOVARTIS 20MG/ML HYDRALAZINE HYDROCHLORIDE ABRAXIS PHARM 20MG/ML SMITH AND NEPHEW 20MG/ML SOLOPAK 20MG/ML TEVA PARENTERAL 20MG/ML TABLET; ORAL APRESOLINE NOVARTIS 10MG 25MG 50MG 100MG DRALZINE TEVA 25MG HYDRALAZINE HYDROCHLORIDE ACTAVIS TOTOWA 25MG 50MG ASCOT 25MG 50MG HALSEY 10MG 25MG 50MG 100MG IMPAX LABS 25MG 50MG IVAX SUB TEVA PHARMS 10MG 25MG 50MG 100MG MUTUAL PHARM 10MG 10MG 25MG 25MG 50MG 50MG 100MG PUREPAC PHARM 25MG 50MG QUANTUM PHARMICS 10MG 25MG 50MG 100MG SANDOZ 10MG 25MG

N008303 A089532 A088518 A088517 A040373

003 001 001 001 001 Aug Apr Aug Feb 11, 20, 22, 23, 1987 1984 1985 2000

N008303 N008303 N008303 N008303 A084301 A088560 A088649 A088310 A088311 A089218 A089130 A089222 A089178 A084922 A084923 A084443 A084437 A084469 A084581 A088728 A089359 A084106 A089258 A084107 A089259 A088729 A088177 A088178 A088671 A088657 A088652 A088686 A083241 A083560

004 001 002 005 001 001 001 001 001 001 001 001 001 001 001 001 001 002 001 001 001 002 001 002 001 001 001 001 001 001 001 001 001 001 Oct Oct Dec Dec Jan Jan Jan Jan 04, 18, 19, 19, 22, 15, 22, 15, 1984 1984 1984 1984 1986 1986 1986 1986

Apr 11, 1985 Jul 25, 1986 May 05, 1986 May Apr Jul Aug May Jun May May 05, 11, 29, 15, 01, 15, 08, 01, 1986 1985 1983 1983 1984 1984 1984 1984

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

HYDRALAZINE HYDROCHLORIDE
TABLET; ORAL HYDRALAZINE HYDROCHLORIDE SANDOZ 50MG 50MG SUPERPHARM 10MG 25MG 50MG TG UNITED LABS 10MG 25MG 50MG 100MG USL PHARMA 25MG 50MG VANGARD 25MG 50MG VITARINE 25MG WATSON LABS 25MG 50MG WEST WARD 25MG 50MG

6 - 166 (of 346)

A083561 A085088 A088787 A088788 A088789 A088846 A088847 A088848 A088849 A087780 A087751 A087712 A087908 A086088 A085532 A085533 A088240 A088241

001 001 001 001 001 001 001 001 001 001 001 001 001 001 002 002 001 001

Aug Aug Aug Feb Feb Feb Feb Mar Mar

28, 28, 28, 26, 26, 26, 26, 29, 29,

1984 1984 1984 1985 1985 1985 1985 1982 1982

May 07, 1982 May May May May 24, 25, 27, 27, 1982 1982 1983 1983

HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

CAPSULE; ORAL APRESAZIDE NOVARTIS

25MG;25MG 50MG;50MG 100MG;50MG HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE SOLVAY 25MG;25MG 50MG;50MG 100MG;50MG SUPERPHARM 25MG;25MG 50MG;50MG WATSON LABS 25MG;25MG 50MG;50MG 100MG;50MG HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 100/50 IVAX PHARMS 100MG;50MG HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 25/25 IVAX PHARMS 25MG;25MG HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 50/50 IVAX PHARMS 50MG;50MG HYDRA-ZIDE PAR PHARM 100MG;50MG TABLET; ORAL APRESOLINE-ESIDRIX NOVARTIS 25MG;15MG HYDRALAZINE AND HYDROCHLORTHIAZIDE WATSON LABS 25MG;15MG HYDROCHLOROTHIAZIDE W/ HYDRALAZINE WATSON LABS 25MG;15MG

A084735 A084810 A084811 A087608 A087213 A087609 A089200 A089201 A085457 A085446 A085440 A088358 A088356 A088357 A088961

001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 Feb Feb Feb Feb Feb Mar Mar Mar 08, 08, 08, 09, 09, 04, 04, 04, 1982 1982 1982 1987 1987 1982 1982 1982

Apr 10, 1984 Apr 10, 1984 Apr 10, 1984 Oct 21, 1985

N012026 A085827 A085373

002 001 001

HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE

TABLET; ORAL CAM-AP-ES TG UNITED LABS 25MG;15MG;0.1MG HYDRALAZINE HYDROCHLORIDE, HYDROCHLOROTHIAZIDE AND RESERPINE IVAX SUB TEVA PHARMS 25MG;15MG;0.1MG HYDRALAZINE HYDROCHLORIDE-HYDROCHLOROTHIAZIDE-RESERPINE MYLAN 25MG;15MG;0.1MG HYDRALAZINE, HYDROCHLOROTHIAZIDE W/ RESERPINE WATSON LABS 25MG;15MG;0.1MG

A084897 A084291 A087085 A085771

001 001 001 001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE
TABLET; ORAL HYDRAP-ES SANDOZ 25MG;15MG;0.1MG HYDROCHLOROTHIAZIDE W/ RESERPINE AND HYDRALAZINE WATSON LABS 25MG;15MG;0.1MG HYDROSERPINE PLUS (R-H-H) IVAX SUB TEVA PHARMS 25MG;15MG;0.1MG RESERPINE, HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE MUTUAL PHARM 25MG;15MG;0.1MG SOLVAY 25MG;15MG;0.1MG WATSON LABS 25MG;15MG;0.1MG 25MG;15MG;0.1MG RESERPINE, HYDROCHLOROTHIAZIDE, AND HYDRALAZINE HYDROCHLORIDE LEDERLE 25MG;15MG;0.1MG SER-A-GEN SOLVAY 25MG;15MG;0.1MG SER-AP-ES NOVARTIS 25MG;15MG;0.1MG UNIPRES SOLVAY 25MG;15MG;0.1MG 25MG;15MG;0.1MG

6 - 167 (of 346)

A084876 A083770 A083877 A088570 A088376 A085549 A087556 A087709 A087210 N012193 A085893 A086298

001 001 001 001 001 001 001 001 001 005 001 001 Apr 10, 1984 Oct 28, 1983

May 13, 1982

HYDRALAZINE HYDROCHLORIDE; RESERPINE

TABLET; ORAL DRALSERP SANDOZ SERPASIL-APRESOLINE NOVARTIS

25MG;0.1MG 25MG;0.1MG 50MG;0.2MG

A084617 N009296 N009296

001 004 002

HYDROCHLOROTHIAZIDE
SOLUTION; ORAL HYDROCHLOROTHIAZIDE MORTON GROVE 50MG/5ML ROXANE 50MG/5ML HYDROCHLOROTHIAZIDE INTENSOL ROXANE 100MG/ML TABLET; ORAL ESIDRIX NOVARTIS 25MG 50MG 100MG HYDROCHLOROTHIAZIDE ABC HOLDING 50MG ACTAVIS ELIZABETH 25MG 50MG ALRA 25MG 50MG ASCOT 25MG 50MG BARR 50MG DAVA PHARMS INC 100MG ELKINS SINN 50MG HEATHER 50MG IMPAX LABS 25MG 50MG 100MG INWOOD LABS 25MG 25MG 50MG IVAX SUB TEVA PHARMS 50MG 100MG

A089661 A088587 A088588

001 001 001

Jun 20, 1988 Jul 02, 1984 Jul 02, 1984

N011793 N011793 N011793 A085672 A085054 A085208 A086369 A083554 A087539 A087540 A084771 A087060 A085152 A084135 A084029 A083607 A085098 A084776 A085067 A084776 A084658 A085022

005 008 009 001 002 001 001 001 001 001 001 001 002 001 001 002 001 001 001 002 001 001

Feb 03, 1982 Feb 03, 1982

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

HYDROCHLOROTHIAZIDE
TABLET; ORAL HYDROCHLOROTHIAZIDE MAST MM MUTUAL PHARM

6 - 168 (of 346)

MYLAN PVT FORM ROXANE

SANDOZ

SOLVAY SUPERPHARM

TEVA TG UNITED LABS USL PHARMA VANGARD WARNER CHILCOTT WATSON LABS

WEST WARD WHITEWORTH TOWN PLSN

25MG 50MG 25MG 50MG 100MG 25MG 50MG 50MG 25MG 50MG 50MG 25MG 25MG 50MG 50MG 25MG 25MG 50MG 100MG 25MG 50MG 25MG 50MG 25MG 50MG 25MG 50MG 25MG 50MG 25MG 25MG 50MG 50MG 50MG 50MG 50MG 100MG 100MG 100MG 25MG 25MG 50MG 100MG 25MG 50MG 25MG 50MG 100MG 25MG 50MG

A086192 A086192 A083972 A083972 A083972 A084880 A085112 A086597 A085004 A084536 A085005 A083899 A087565 A084912 A085219 A085323 A088827 A088828 A088829 A088924 A088923 A085683 A083965 A087827 A087752 A087638 A087610 A087586 A087587 A083458 A085232 A083232 A083456 A085233 A086087 A086594 A081190 A085099 A087002 A084899 A083809 A083809 A085347 A086504 A083891 N011835 N011835 N011835 N011971 A083925

001 002 001 002 003 001 001 001 001 002 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 002 001 001 001 001 001 001 001 001 001 002 001 001 001 002 003 006 007 001 001

Mar 09, 1982

Dec Dec Dec Feb Feb

28, 28, 28, 07, 07,

1984 1984 1984 1985 1985

Apr 19, 1982 Apr 19, 1982

May 03, 1982 May 03, 1982

Jan 24, 1992

HYDRO-D HALSEY HYDRODIURIL MERCK

ORETIC ABBOTT ZIDE SOLVAY

HYDROCHLOROTHIAZIDE; IRBESARTAN
TABLET; ORAL AVALIDE SANOFI AVENTIS

12.5MG;75MG 25MG;300MG

N020758 N020758

001 004

Sep 30, 1997 Mar 15, 2005

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE
TABLET; ORAL NORMOZIDE SCHERING

6 - 169 (of 346)

25MG;100MG 25MG;200MG 25MG;300MG 25MG;400MG 25MG;100MG 25MG;200MG 25MG;300MG 25MG;400MG

N019046 N019046 N019046 N019046 N019174 N019174 N019174 N019174

001 002 003 004 001 002 003 004

Apr Apr Apr Apr Apr Apr Apr Apr

06, 06, 06, 06, 10, 10, 10, 10,

1987 1987 1987 1987 1987 1987 1987 1987

TRANDATE HCT GLAXOSMITHKLINE

HYDROCHLOROTHIAZIDE; LISINOPRIL
TABLET; ORAL LISINOPRIL AND HYDROCHLOROTHIAZIDE SANDOZ 12.5MG;10MG 12.5MG;20MG 25MG;20MG TEVA 12.5MG;10MG 12.5MG;20MG 25MG;20MG PRINZIDE MERCK 25MG;20MG

A075926 A075926 A075926 A075869 A075869 A075869 N019778

001 002 003 001 002 003 002

Jul Jul Jul Jul Jul Jul

01, 01, 01, 01, 01, 01,

2002 2002 2002 2002 2002 2002

Feb 16, 1989

HYDROCHLOROTHIAZIDE; METHYLDOPA
TABLET; ORAL ALDORIL 15 MERCK 15MG;250MG ALDORIL 25 MERCK 25MG;250MG ALDORIL D30 MERCK 30MG;500MG ALDORIL D50 MERCK 50MG;500MG METHYLDOPA AND HYDROCHLOROTHIAZIDE CLONMEL HLTHCARE 15MG;250MG 25MG;250MG 30MG;500MG 50MG;500MG IVAX SUB TEVA PHARMS 15MG;250MG 25MG;250MG 30MG;500MG 50MG;500MG PAR PHARM 15MG;250MG 25MG;250MG 30MG;500MG 50MG;500MG PARKE DAVIS 15MG;250MG 25MG;250MG 30MG;500MG 50MG;500MG PUREPAC PHARM 15MG;250MG 25MG;250MG 30MG;500MG 50MG;500MG SANDOZ 15MG;250MG 15MG;250MG 25MG;250MG 25MG;250MG 30MG;500MG 50MG;500MG TEVA 15MG;250MG

N013402 N013402 N013402 N013402 A072507 A072508 A072509 A072510 A071458 A071459 A071460 A071461 A070616 A070612 A070613 A070614 A071897 A071898 A071899 A071900 A070853 A070688 A070854 A070689 A070182 A070829 A070183 A070830 A070543 A070544 A071819

001 002 003 004 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 Jun Jun Jun Jun Mar Mar Mar Mar Feb Feb Feb Feb Nov Nov Nov Nov Oct Apr Oct Apr Jan Mar Jan Mar Jan Jan Apr 02, 02, 02, 02, 08, 08, 08, 08, 02, 02, 02, 02, 23, 23, 23, 23, 08, 24, 08, 24, 15, 09, 15, 09, 15, 15, 08, 1989 1989 1989 1989 1988 1988 1988 1988 1987 1987 1987 1987 1987 1987 1987 1987 1986 1986 1986 1986 1986 1987 1986 1987 1986 1986 1988

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

HYDROCHLOROTHIAZIDE; METHYLDOPA
TABLET; ORAL METHYLDOPA AND HYDROCHLOROTHIAZIDE TEVA 25MG;250MG 30MG;500MG 50MG;500MG WATSON LABS 15MG;250MG 15MG;250MG 15MG;250MG 25MG;250MG 25MG;250MG 25MG;250MG 30MG;500MG 30MG;500MG 30MG;500MG 50MG;500MG 50MG;500MG 50MG;500MG

6 - 170 (of 346)

A071820 A071821 A071822 A070365 A070958 A071920 A070366 A070959 A071921 A070367 A071069 A071922 A070368 A070960 A071923

001 001 001 001 001 001 001 001 001 001 001 001 001 001 001

Apr Apr Apr Mar Feb Aug Apr Jan Aug Mar Jan Aug Apr Feb Aug

08, 08, 08, 19, 06, 29, 16, 19, 29, 19, 19, 29, 16, 06, 29,

1988 1988 1988 1986 1989 1988 1986 1989 1988 1986 1989 1988 1986 1989 1988

HYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE

TABLET, EXTENDED RELEASE; ORAL DUTOPROL ASTRAZENECA 12.5MG;EQ 25MG TARTRATE 12.5MG;EQ 50MG TARTRATE 12.5MG;EQ 100MG TARTRATE

N021956 N021956 N021956

001 002 003

Aug 28, 2006 Aug 28, 2006 Aug 28, 2006

HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE

TABLET; ORAL LOPRESSOR HCT NOVARTIS

50MG;100MG

N018303

003

Dec 31, 1984

HYDROCHLOROTHIAZIDE; PINDOLOL
TABLET; ORAL VISKAZIDE NOVARTIS

25MG;5MG 25MG;10MG

N018872 N018872

001 002

Jul 22, 1987 Jul 22, 1987

HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE; ORAL INDERIDE LA 120/50 WYETH AYERST 50MG;120MG INDERIDE LA 160/50 WYETH AYERST 50MG;160MG INDERIDE LA 80/50 WYETH AYERST 50MG;80MG TABLET; ORAL INDERIDE-80/25 AKRIMAX PHARMS 25MG;80MG PROPRANOLOL HYDROCHLORIDE & HYDROCHLOROTHIAZIDE DURAMED PHARMS BARR 25MG;40MG 25MG;80MG PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE ACTAVIS ELIZABETH 25MG;40MG 25MG;80MG BARR 25MG;40MG 25MG;80MG IVAX SUB TEVA PHARMS 25MG;40MG 25MG;80MG SANDOZ 25MG;40MG 25MG;80MG WARNER CHILCOTT 25MG;40MG 25MG;80MG WATSON LABS 25MG;40MG

N019059 N019059 N019059

002 003 001

Jul 03, 1985 Jul 03, 1985 Jul 03, 1985

N018031 A071126 A071127 A070851 A070852 A070704 A070705 A071552 A071553 A071060 A071061 A071771 A071772 A071498

002 001 001 001 001 001 001 001 001 001 001 001 001 001 Mar 02, 1987 Mar 02, 1987 May May Oct Oct Dec Dec Aug Aug Jan Jan Dec 15, 15, 01, 01, 01, 01, 26, 26, 26, 26, 18, 1986 1986 1986 1986 1988 1988 1987 1987 1988 1988 1991

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE
TABLET; ORAL PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE WATSON LABS 25MG;80MG

6 - 171 (of 346)

A071501

001

Dec 18, 1991

HYDROCHLOROTHIAZIDE; RESERPINE
TABLET; ORAL H.R.-50 WHITEWORTH TOWN PLSN 50MG;0.125MG HYDROCHLOROTHIAZIDE W/ RESERPINE IVAX SUB TEVA PHARMS 25MG;0.1MG 25MG;0.125MG 50MG;0.1MG 50MG;0.125MG PHARMERAL 25MG;0.125MG 50MG;0.125MG ROXANE
50MG;0.125MG WATSON LABS
25MG;0.125MG 25MG;0.125MG 25MG;0.125MG 50MG;0.125MG 50MG;0.125MG 50MG;0.125MG HYDROPRES 25 MERCK 25MG;0.125MG HYDROPRES 50 MERCK 50MG;0.125MG HYDRO-RESERP ABC HOLDING 50MG;0.125MG HYDRO-SERP "25" SANDOZ 25MG;0.125MG HYDRO-SERP "50" SANDOZ 50MG;0.125MG RESERPINE AND HYDROCHLOROTHIAZIDE BARR 25MG;0.125MG 50MG;0.125MG SANDOZ 50MG;0.125MG RESERPINE AND HYDROCHLOROTHIAZIDE-50 WEST WARD 50MG;0.125MG SERPASIL-ESIDRIX #1 NOVARTIS 25MG;0.1MG SERPASIL-ESIDRIX #2 NOVARTIS 50MG;0.1MG

A085338 A083572 A083571 A083568 A083573 A085421 A085420 A084603 A084466 A085317 A086330 A083666 A084467 A086331 N011958 N011958 A084714 A084827 A085213 A084580 A084579 A088200 A088189 N011878 N011878

001 001 001 001 001 001 001 001 001 001 002 001 001 001 002 003 002 001 001 001 001 001 001 003 005 Jun 29, 1982

Jan 31, 1984 May 10, 1984

HYDROCHLOROTHIAZIDE; SPIRONOLACTONE
TABLET; ORAL SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE ASCOT 25MG;25MG MUTUAL PHARM 25MG;25MG PUREPAC PHARM 25MG;25MG SANDOZ 25MG;25MG SUPERPHARM 25MG;25MG SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE IVAX PHARMS 25MG;25MG LEDERLE 25MG;25MG PARKE DAVIS 25MG;25MG PUREPAC PHARM 25MG;25MG UPSHER SMITH 25MG;25MG USL PHARMA 25MG;25MG VANGARD 25MG;25MG WATSON LABS 25MG;25MG 25MG;25MG

A088025 A087267 A087999 A086881 A089137 A087004 A087511 A087948 A088054 A087553 A087651 A087655 A085974 A086026

001 001 001 001 001 002 001 001 001 001 001 001 001 001

Nov 23, 1984 Nov 06, 1985 Aug 26, 1985 May 24, 1982 Feb 22, 1983 Aug 18, 1983

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

HYDROCHLOROTHIAZIDE; TIMOLOL MALEATE
TABLET; ORAL TIMOLIDE 10-25 MERCK

6 - 172 (of 346)

25MG;10MG

N018061

001

HYDROCHLOROTHIAZIDE; TRIAMTERENE
CAPSULE; ORAL DYAZIDE GLAXOSMITHKLINE LLC 25MG;50MG TRIAMTERENE AND HYDROCHLOROTHIAZIDE BARR 25MG;37.5MG NOVARTIS 25MG;37.5MG VITARINE 25MG;50MG TABLET; ORAL TRIAMTERENE AND HYDROCHLOROTHIAZIDE AM THERAP 50MG;75MG QUANTUM PHARMICS 50MG;75MG

N016042 A074970 A074857 A071737

002 001 001 001 Jan 06, 1998 Sep 09, 1997 Feb 12, 1988

A072022 A071980

001 001

Apr 17, 1988 Apr 17, 1988

HYDROCODONE BITARTRATE; PHENYLPROPANOLAMINE HYDROCHLORIDE

SYRUP; ORAL CODAMINE ALPHARMA US PHARMS HYCOMINE ENDO PHARMS HYCOMINE PEDIATRIC ENDO PHARMS

5MG/5ML;25MG/5ML 5MG/5ML;25MG/5ML 2.5MG/5ML;12.5MG/5ML

A075103 N019410 N019411

001 001 001

Sep 29, 2000 Aug 17, 1990 Aug 17, 1990

HYDROCORTAMATE HYDROCHLORIDE
OINTMENT; TOPICAL MAGNACORT PFIZER

0.5%

N010554

001

HYDROCORTISONE
AEROSOL; TOPICAL AEROSEB-HC ALLERGAN HERBERT CREAM; TOPICAL CORT-DOME BAYER PHARMS DERMACORT MONARCH PHARMS ELDECORT VALEANT PHARM INTL FLEXICORT WESTWOOD SQUIBB

0.5%

A085805

001

0.5% 1% 1% 1% 2.5% 0.5% 1% 2.5% 0.5% 1% 0.5% 1% 0.5% 2.5% 2.5% 0.5%

N009585 N009585 A083011 A080459 A084055 A087136 A087136 A087136 A080438 A080438 A080482 A080482 A086823 A080483 A089754 A080848

003 001 002 001 001 003 002 001 001 002 003 004 001 001 001 002 Feb 01, 1989 Apr 08, 1982 Apr 08, 1982 Apr 08, 1982

HC #1 BAYER PHARMS HC #4 BAYER PHARMS HC (HYDROCORTISONE) C AND M PHARMA H-CORT PHARM ASSOC HI-COR C AND M PHARMA HYDROCORTISONE ALPHARMA US PHARMS ALTANA

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

HYDROCORTISONE
CREAM; TOPICAL HYDROCORTISONE ALTANA AMBIX EVERYLIFE G AND W LABS INGRAM PHARM IVAX PHARMS NASKA PERRIGO NEW YORK PHARMADERM PHARMAFAIR STIEFEL SYOSSET TARO TEVA

6 - 173 (of 346)

TOPIDERM USL PHARMA WHITEWORTH TOWN PLSN HYTONE SANOFI AVENTIS US NOGENIC HC IVAX PHARMS NUTRACORT CORIA PENECORT ALLERGAN HERBERT PROCTOCORT MONARCH PHARMS SYNACORT MEDICIS GEL; TOPICAL NUTRACORT HEALTHPOINT PENECORT ALLERGAN HERBERT INJECTABLE; INJECTION CORTEF PHARMACIA AND UPJOHN LOTION; TOPICAL ACTICORT BAKER NORTON BALNEOL-HC SOLVAY BETA-HC BETA DERMAC CETACORT CORIA CORT-DOME BAYER PHARMS

1% 1% 2.5% 0.5% 1% 1% 0.5% 1% 1% 1% 0.5% 1% 1% 2.5% 1% 1% 0.5% 0.5% 0.5% 1% 1% 2.5% 1% 1% 2.5% 1% 1% 2.5% 1% 0.5% 1% 1% 1% 0.5%

A080848 A086080 A086271 A080452 A080452 A084059 A080456 A080456 A085733 A089706 A084970 A085026 A088845 A089413 A087838 A086170 A085527 A086154 A080400 A080400 A085191 A080400 A089273 A088027 A088029 A080496 A080472 A080472 A087427 A080442 A080442 A088216 A083011 A087459

003 001 001 001 002 001 002 003 001 001 002 001 001 001 001 001 001 001 002 003 001 004 001 001 001 002 003 004 001 002 003 001 001 001

Mar 10, 1988

Feb 27, 1986 Dec 16, 1986 Jul 28, 1982

Feb 17, 1989 Sep 27, 1983 Sep 27, 1983

Apr 04, 1988

Jun 06, 1984

1% 1%

A084698 A088215

001 001 Jun 06, 1984

50MG/ML

N009864

001

1% 1% 1% 0.5% 1% 0.5% 1%

A086535 A088041 A089495 A080426 A080426 N009895 N009895

001 001 001 002 001 003 001 Dec 03, 1982 Jan 25, 1988

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

HYDROCORTISONE
LOTION; TOPICAL DERMACORT SOLVAY EPICORT BLULINE GLYCORT HERAN H-CORT PHARM ASSOC HYDROCORTISONE ALPHARMA US PHARMS MERICON NASKA PERRIGO NEW YORK TARO HYTONE SANOFI AVENTIS US NUTRACORT CORIA OINTMENT; TOPICAL CORTRIL PFIZER GLOBAL HC (HYDROCORTISONE) C AND M PHARMA HYDROCORTISONE ALTANA AMBIX NASKA PERRIGO NEW YORK PHARMADERM TARO USL PHARMA HYTONE DERMIK LABS

6 - 174 (of 346)

0.5% 1% 0.5% 1% 0.5% 0.5% 1% 0.5% 1% 1% 0.5% 1% 1% 1% 2.5% 0.5%

A084573 A086462 A083219 A087489 A086824 A087317 A087315 A085282 A085282 A089705 A085662 A085663 A089024 A080473 A080473 A080443

002 001 002 001 001 001 001 001 002 001 001 001 001 003 004 002 Jun 07, 1982 Jun 07, 1982 Feb 26, 1987 Apr 25, 1988 Oct 03, 1983

Feb 12, 1986

Nov 30, 1982

1% 2.5% 0.5% 1% 0.5% 1% 1% 2.5% 1% 0.5% 1% 1% 0.5% 1% 2.5% 1% 2.5%

N009176 N009176 A080481 A080481 A080489 A080489 A086079 A086272 A089704 A084969 A085028 A088842 A086256 A088061 A088039 A080474 A080474 A088217

001 002 001 002 002 003 001 001 001 003 001 001 001 001 001 003 004 001 Jun 06, 1984

Mar 10, 1988

Feb 09, 1987 Sep 27, 1983 Sep 27, 1983

PENECORT ALLERGAN HERBERT 2.5% POWDER; FOR RX COMPOUNDING H-CORT TORCH 100% HYDROCORTISONE PADDOCK LLC 100% SOLUTION; TOPICAL PENECORT ALLERGAN HERBERT 1% TEXACORT MISSION PHARMA 1% TABLET; ORAL CORTRIL PFIZER 10MG 20MG

A087834 A088082

001 001

Mar 29, 1982 Apr 08, 1983

A088214 A080425

001 001

Jun 06, 1984

N009127 N009127

005 003

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

HYDROCORTISONE
TABLET; ORAL HYDROCORTISONE BARR ELKINS SINN FERRANTE IMPAX LABS INWOOD LABS LANNETT NEXGEN PHARMA INC PANRAY PARKE DAVIS PUREPAC PHARM

6 - 175 (of 346)

ROXANE SANDOZ WATSON LABS WHITEWORTH TOWN PLSN HYDROCORTONE MERCK TABLET; VAGINAL CORTRIL PFIPHARMECS

20MG 20MG 10MG 20MG 20MG 20MG 20MG 20MG 10MG 20MG 20MG 10MG 20MG 20MG 10MG 20MG 20MG 10MG 20MG 10MG 20MG

A083999 A080624 A080568 A080568 A080781 A080732 A085070 A083140 N009659 N009659 A084243 A084247 A080395 A084247 A088539 A080642 A080355 A080344 A080344 N008506 N008506

001 001 001 002 001 001 001 001 001 002 001 003 001 002 001 002 001 001 002 007 011

Aug 31, 1982

Mar 21, 1984

10MG

N009796

001

HYDROCORTISONE ACETATE
CREAM; TOPICAL HEMSOL-HC ABLE HYDROCORTISONE ACETATE CENCI PARKE DAVIS PUREPAC PHARM INJECTABLE; INJECTION CORTEF ACETATE PHARMACIA AND UPJOHN CORTRIL PFIZER HYDROCORTISONE ACETATE AKORN BEL MAR WATSON LABS

1% 1% 1% 0.5% 1%

A081274 A080419 A089914 A086050 A086052

001 001 001 001 001

Jun 19, 1992 Jan 25, 1982 Jan 03, 1989

50MG/ML 25MG/ML 25MG/ML 50MG/ML 25MG/ML 50MG/ML 25MG/ML 25MG/ML 50MG/ML 50MG/ML 25MG/ML 50MG/ML

N009378 N009164 N009637 N009637 A083739 A083739 A083128 A083759 A083759 A085214 N008228 N008228

002 001 001 002 001 002 001 001 002 001 001 004

HYDROCORTONE MERCK

LOTION; TOPICAL DRICORT INGRAM PHARM 0.5% OINTMENT; OPHTHALMIC HYDROCORTISONE ACETATE FERA PHARMS 0.5% OINTMENT; OPHTHALMIC, OTIC HYDROCORTONE MERCK 1.5%

A086207

001

A080828

001

N009018

003

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DISCONTINUED DRUG PRODUCT LIST

HYDROCORTISONE ACETATE
OINTMENT; TOPICAL CORTEF ACETATE PHARMACIA AND UPJOHN

6 - 176 (of 346)

1% 2.5%

N008917 N008917

002 001

HYDROCORTISONE ACETATE; NEOMYCIN SULFATE

CREAM; TOPICAL NEO-CORTEF PHARMACIA AND UPJOHN OINTMENT; OPHTHALMIC NEO-CORTEF PHARMACIA AND UPJOHN OINTMENT; TOPICAL NEO-CORTEF PHARMACIA AND UPJOHN

1%;EQ 3.5MG BASE/GM 2.5%;EQ 3.5MG BASE/GM

A061049 A061049

001 002

0.5%;EQ 3.5MG BASE/GM 1.5%;EQ 3.5MG BASE/GM

A060610 A060610

001 002

0.5%;EQ 3.5MG BASE/GM 1%;EQ 3.5MG BASE/GM 2.5%;EQ 3.5MG BASE/GM SUSPENSION/DROPS; OPHTHALMIC COR-OTICIN AKORN 1.5%;EQ 3.5MG BASE/ML NEO-CORTEF PHARMACIA AND UPJOHN 0.5%;EQ 3.5MG BASE/ML 1.5%;EQ 3.5MG BASE/ML

A060751 A060751 A060751

001 002 003

A060188 A060612 A060612

001 002 001

HYDROCORTISONE ACETATE; OXYTETRACYCLINE HYDROCHLORIDE

SUSPENSION; OPHTHALMIC TERRA-CORTRIL PFIZER

1.5%;EQ 5MG BASE/ML

A061016

001

HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE

AEROSOL, METERED; TOPICAL HYDROCORTISONE ACETATE 1% AND PRAMOXINE HYDROCHLORIDE 1% BOCA PHARMA 1%;1% LOTION; TOPICAL PRAMOSONE FERNDALE LABS 0.5%;1%

A089440

001

May 17, 1988

A083213

002

HYDROCORTISONE BUTYRATE
CREAM; TOPICAL LOCOID YAMANOUCHI OINTMENT; TOPICAL LOCOID YAMANOUCHI SOLUTION; TOPICAL LOCOID YAMANOUCHI

0.1%

N018795

001

Jan 07, 1983

0.1%

N019106

001

Jul 03, 1984

0.1%

N019819

001

Sep 15, 1988

HYDROCORTISONE CYPIONATE
SUSPENSION; ORAL CORTEF PHARMACIA AND UPJOHN

EQ 10MG BASE/5ML

N009900

001

HYDROCORTISONE SODIUM PHOSPHATE

INJECTABLE; INJECTION HYDROCORTONE MERCK

EQ 50MG BASE/ML

N012052

001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

HYDROCORTISONE SODIUM SUCCINATE
INJECTABLE; INJECTION A-HYDROCORT ABBOTT

6 - 177 (of 346)

EQ 100MG BASE/VIAL EQ 100MG BASE/VIAL EQ 250MG BASE/VIAL EQ 500MG BASE/VIAL EQ 1GM BASE/VIAL HOSPIRA EQ 100MG BASE/VIAL EQ 250MG BASE/VIAL EQ 500MG BASE/VIAL EQ 1GM BASE/VIAL HYDROCORTISONE SODIUM SUCCINATE ABRAXIS PHARM EQ 100MG BASE/VIAL EQ 100MG BASE/VIAL EQ 250MG BASE/VIAL EQ 500MG BASE/VIAL EQ 1GM BASE/VIAL BAXTER HLTHCARE EQ 100MG BASE/VIAL EQ 250MG BASE/VIAL EQ 500MG BASE/VIAL EQ 1GM BASE/VIAL INTL MEDICATION EQ 100MG BASE/VIAL WATSON LABS EQ 100MG BASE/VIAL EQ 100MG BASE/VIAL EQ 250MG BASE/VIAL EQ 500MG BASE/VIAL EQ 1GM BASE/VIAL

A085928 A089577 A089578 A089579 A089580 A085929 A085930 A085931 A085932 A088667 A088712 A088668 A088669 A088670 A086619 A087567 A087568 A087569 A087532 A084737 A084738 A084737 A084747 A084748

001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 002 001 001 001 001

Apr Apr Apr Apr

11, 11, 11, 11,

1989 1989 1989 1989

Jun Jun Jun Jun Jun

08, 08, 08, 08, 08,

1984 1984 1984 1984 1984

Mar 19, 1982

HYDROCORTISONE VALERATE
CREAM; TOPICAL HYDROCORTISONE VALERATE TEVA PHARMS 0.2%

A074489

001

Aug 12, 1998

HYDROCORTISONE; NEOMYCIN SULFATE

CREAM; TOPICAL NEO-CORT-DOME BAYER PHARMS

0.5%;EQ 3.5MG BASE/GM 1%;EQ 3.5MG BASE/GM

N050237 N050237

006 005

Jun 05, 1984 Jun 05, 1984

HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

SOLUTION/DROPS; OTIC NEOMYCIN SULFATE-POLYMYXIN B SULFATE-HYDROCORTISONE PHARMAFAIR 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML OTOCORT WATSON LABS 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML SUSPENSION/DROPS; OPHTHALMIC CORTISPORIN MONARCH PHARMS 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML NEOMYCIN SULFATE-POLYMYXIN B SULFATE-HYDROCORTISONE PHARMAFAIR 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML SUSPENSION/DROPS; OTIC NEOMYCIN SULFATE, POLYMYXIN B SULFATE & HYDROCORTISONE PHARMAFAIR 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML OTICAIR PHARMAFAIR 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML OTOBIONE SCHERING 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML OTOCORT WATSON LABS 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML

A062394 A060730

001 002

Sep 29, 1982

N050169 A062623

001 001 Sep 24, 1985

A062617 A062399 A061816 A062521

001 001 001 001

Sep 18, 1985 Nov 18, 1982

Jul 11, 1985

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

HYDROCORTISONE; POLYMYXIN B SULFATE
SOLUTION/DROPS; OTIC OTOBIOTIC SCHERING PYOCIDIN FOREST LABS

6 - 178 (of 346)

5MG/ML;EQ 10,000 UNITS BASE/ML 5MG/ML;EQ 10,000 UNITS BASE/ML

A062302 A061606

001 001

HYDROCORTISONE; TETRACYCLINE HYDROCHLORIDE

OINTMENT; OPHTHALMIC ACHROMYCIN LEDERLE

1.5%;1%

N050272

001

HYDROCORTISONE; UREA
CREAM; TOPICAL ALPHADERM BIOGLAN CALMURID HC PHARMACIA AND UPJOHN

1%;10% 1%;10%

A086008 A083947

001 001

HYDROFLUMETHIAZIDE
TABLET; ORAL DIUCARDIN WYETH AYERST HYDROFLUMETHIAZIDE PAR PHARM WATSON LABS

50MG 50MG 50MG 50MG

A083383 A088850 A088031 A088528

001 001 001 001 May 31, 1985 Apr 06, 1983 Aug 15, 1984

HYDROFLUMETHIAZIDE; RESERPINE
TABLET; ORAL HYDROFLUMETHIAZIDE AND RESERPINE USL PHARMA 50MG;0.125MG WATSON LABS 25MG;0.125MG 50MG;0.125MG RESERPINE AND HYDROFLUMETHIAZIDE IVAX PHARMS 50MG;0.125MG PAR PHARM 50MG;0.125MG SALUTENSIN SHIRE 50MG;0.125MG SALUTENSIN-DEMI SHIRE 25MG;0.125MG

A088195 A088127 A088110 A088932 A088907 N012359 N012359

001 001 001 001 001 003 004

Oct 26, 1983 Mar 22, 1983 Mar 22, 1983 Jan 11, 1985 Sep 20, 1985

HYDROMORPHONE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL PALLADONE PURDUE PHARMA LP 12MG 16MG 24MG 32MG INJECTABLE; INJECTION HYDROMORPHONE HYDROCHLORIDE WATSON LABS 10MG/ML

N021044 N021044 N021044 N021044

001 002 003 004

Sep Sep Sep Sep

24, 24, 24, 24,

2004 2004 2004 2004

A074317

001

Aug 23, 1995

HYDROXOCOBALAMIN
INJECTABLE; INJECTION ALPHAREDISOL MERCK CYANOKIT MERCK SANTE SAS HYDROXOCOBALAMIN ABRAXIS PHARM WATSON LABS

1MG/ML 2.5GM/VIAL (5GM/KIT) 1MG/ML 1MG/ML

A080778 N022041 A084921 A085528

001 002 001 001 Dec 15, 2006

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

HYDROXOCOBALAMIN
INJECTABLE; INJECTION HYDROXOMIN BEL MAR

6 - 179 (of 346)

1MG/ML

A084629

001

HYDROXYAMPHETAMINE HYDROBROMIDE
SOLUTION/DROPS; OPHTHALMIC PAREDRINE PHARMICS 1%

N000004

004

HYDROXYPROGESTERONE CAPROATE
INJECTABLE; INJECTION DELALUTIN BRISTOL MYERS SQUIBB

125MG/ML 125MG/ML 250MG/ML 250MG/ML HYDROXYPROGESTERONE CAPROATE AKORN 125MG/ML WATSON LABS 125MG/ML 250MG/ML

N010347 N016911 N010347 N016911 N018004 N017439 N017439

004 001 002 002 001 001 002

HYDROXYSTILBAMIDINE ISETHIONATE
INJECTABLE; INJECTION HYDROXYSTILBAMIDINE ISETHIONATE SANOFI AVENTIS US 225MG/AMP

N009166

001

HYDROXYUREA
CAPSULE; ORAL HYDROXYUREA BARR DURAMED PHARMS BARR ROXANE TABLET; ORAL HYDROXYUREA BARR

250MG 250MG 500MG 500MG

A075143 A075020 A075020 A074476

002 002 001 001

Sep Jun Jul Aug

21, 26, 30, 18,

2000 2000 1998 1995

1GM

A075734

001

Aug 29, 2000

HYDROXYZINE HYDROCHLORIDE
INJECTABLE; INJECTION HYDROXYZINE BAXTER HLTHCARE 50MG/ML HYDROXYZINE HYDROCHLORIDE ALTANA 25MG/ML 50MG/ML APP PHARMS 25MG/ML 50MG/ML BAXTER HLTHCARE 25MG/ML HOSPIRA 25MG/ML 50MG/ML 50MG/ML PHARMAFAIR 25MG/ML 25MG/ML 50MG/ML 50MG/ML SMITH AND NEPHEW 25MG/ML SOLOPAK 25MG/ML 25MG/ML 50MG/ML 50MG/ML 50MG/ML 50MG/ML WATSON LABS 25MG/ML

A085551 A087273 A087273 A088184 A088185 A085551 A087416 A086821 A087546 A088862 A089106 A088881 A089107 A087592 A086822 A087591 A087310 A087593 A087595 A087596 A085778

002 001 002 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 Apr Apr Mar Mar 20, 20, 31, 31, 1982 1982 1983 1983

Feb Feb Feb Feb

14, 14, 14, 14,

1986 1986 1986 1986

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

HYDROXYZINE HYDROCHLORIDE
INJECTABLE; INJECTION HYDROXYZINE HYDROCHLORIDE WATSON LABS 25MG/ML 50MG/ML 50MG/ML WYETH AYERST 25MG/ML 50MG/ML ORGATRAX ORGANON USA INC 25MG/ML 50MG/ML VISTARIL PFIZER 25MG/ML 50MG/ML SYRUP; ORAL ATARAX ROERIG 10MG/5ML HYDROXYZINE HYDROCHLORIDE ACTAVIS MID ATLANTIC 10MG/5ML ALPHARMA US PHARMS 10MG/5ML KV PHARM 10MG/5ML TABLET; ORAL ATARAX PFIZER 10MG 25MG 50MG 100MG HYDROXYZINE HYDROCHLORIDE ABLE 10MG 25MG 50MG ACTAVIS TOTOWA 10MG 10MG 25MG 25MG 50MG 50MG HALSEY 10MG 25MG 50MG IVAX PHARMS 10MG 25MG 50MG KV PHARM 10MG 25MG 50MG 100MG MUTUAL PHARM 10MG 25MG 50MG 100MG PLIVA 100MG PUREPAC PHARM 10MG 25MG 50MG QUANTUM PHARMICS 10MG 25MG 50MG SANDOZ 10MG 10MG 25MG 25MG 50MG 50MG

6 - 180 (of 346)

A087274 A085779 A087274 A086258 A086258 A087014 A087014 N011111 N011111

001 001 002 001 002 001 002 001 002

N010485 A086880 A088785 A087730

001 001 001 001

Feb 03, 1988 Jul 01, 1982

N010392 N010392 N010392 N010392 A040559 A040562 A040563 A040600 A089071 A040602 A089072 A040604 A089073 A089366 A089117 A089396 A087216 A087410 A087411 A087819 A087820 A087821 A087822 A088409 A087857 A087860 A087862 A081054 A088120 A088121 A088122 A088540 A088551 A088529 A087246 A087869 A085247 A087870 A087245 A087871

001 004 006 005 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 002 001 001 001 001 001 Jul Jul Jul Dec Jul Dec Jul Dec Jul May May May 22, 22, 22, 28, 22, 28, 22, 28, 22, 02, 02, 02, 2004 2004 2004 2004 1986 2004 1986 2004 1986 1988 1988 1988

Jun Jun Jun Jun Nov Apr Apr Apr Sep Sep Sep Sep Oct Oct Oct

23, 23, 23, 23, 15, 18, 18, 18, 25, 25, 25, 25, 22, 22, 22,

1982 1982 1982 1982 1983 1983 1983 1983 1995 1984 1984 1984 1985 1985 1985

Dec 20, 1982 Dec 20, 1982 Dec 20, 1982

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

HYDROXYZINE HYDROCHLORIDE
TABLET; ORAL HYDROXYZINE HYDROCHLORIDE SUPERPHARM 10MG 25MG 50MG USL PHARMA 10MG 25MG 50MG VINTAGE 10MG 25MG 50MG WATSON LABS 10MG 25MG 50MG

6 - 181 (of 346)

A088794 A088795 A088796 A089121 A089122 A089123 A087602 A087603 A087604 A086827 A086829 A086836

001 001 001 001 001 001 001 001 001 001 001 001

Dec Dec Dec Mar Mar Mar Jan Jan Jan

05, 05, 05, 20, 20, 20, 22, 22, 22,

1984 1984 1984 1986 1986 1986 1982 1982 1982

HYDROXYZINE PAMOATE
CAPSULE; ORAL HYDROXYZINE PAMOATE DURAMED PHARMS BARR

IVAX SUB TEVA PHARMS PAR PHARM

SANDOZ

SUPERPHARM

VANGARD WATSON LABS

EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ

25MG HCL 50MG HCL 100MG HCL 25MG HCL 50MG HCL 25MG HCL 25MG HCL 50MG HCL 50MG HCL 100MG HCL 25MG HCL 50MG HCL 100MG HCL 25MG HCL 50MG HCL 100MG HCL 25MG HCL 50MG HCL 25MG HCL 25MG HCL 50MG HCL 50MG HCL 50MG HCL 100MG HCL 100MG HCL 100MG HCL

A088593 A088594 A088595 A087761 A087760 A087656 A089145 A087657 A089146 A087658 A081127 A081128 A081129 A089031 A089032 A089033 A088392 A088393 A086698 A086840 A086695 A086705 A087767 A086697 A086728 A087790 A088713 N011459

001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 006

Feb Feb Feb Mar Mar Jun Mar Jun Mar Jun Jun Jun Jun Jan Jan Jan Sep Sep

29, 29, 29, 05, 05, 11, 17, 11, 17, 11, 28, 28, 28, 02, 02, 02, 19, 19,

1984 1984 1984 1982 1982 1982 1986 1982 1986 1982 1991 1991 1991 1987 1987 1987 1983 1983

Jul 01, 1982 Jul 01, 1982 Aug 16, 1982 Oct 05, 1982 Aug 16, 1982 Mar 04, 1985

HY-PAM "25" TEVA VISTARIL PFIZER

EQ 25MG HCL EQ 100MG HCL

IBANDRONATE SODIUM
TABLET; ORAL BONIVA ROCHE

EQ 2.5MG BASE

N021455

001

May 16, 2003

IBUPROFEN
CAPSULE; ORAL MIDOL BAYER SUSPENSION; ORAL CHILDREN'S ADVIL WYETH CONS

200MG 200MG

A070626 A071002

001 001

Sep 02, 1987 Sep 02, 1987

100MG/5ML

N019833

002

Sep 19, 1989

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

IBUPROFEN
SUSPENSION; ORAL IBU ABBOTT MOTRIN MCNEIL CONSUMER SUSPENSION/DROPS; ORAL MOTRIN MCNEIL TABLET; ORAL ACHES-N-PAIN LEDERLE CAP-PROFEN PERRIGO IBU BASF

6 - 182 (of 346)

100MG/5ML 100MG/5ML

N019784 N019842

001 001

Dec 18, 1989 Sep 19, 1989

40MG/ML

N020476

001

May 25, 1995

200MG 200MG 400MG 400MG 600MG 600MG 800MG 200MG 600MG 800MG 200MG 300MG 400MG 600MG 800MG 200MG 200MG 200MG 200MG 200MG 400MG 600MG 800MG 400MG 600MG 300MG 400MG 600MG 200MG 200MG 200MG 400MG 600MG 800MG 200MG 400MG 600MG 800MG 200MG 300MG 400MG 600MG 800MG 200MG 400MG 600MG 800MG 200MG 200MG

A071065 A072097 A070083 N018197 A070088 A070099 A070745 A071773 A070556 A071264 A071027 A071028 A071029 A071030 A072137 A071144 A071154 A072040 A072901 A072903 A071145 A071146 A071769 A070629 A070630 A071266 A070081 A070476 A070493 A070908 A071462 A070079 A070080 A071448 A071870 A070045 A070057 A071999 A071575 A070328 A070329 A070330 A070986 A072098 A071666 A071667 A071668 A071122 A071664

001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001

May 28, 1987 Dec 08, 1987 Feb 22, 1985 Feb 08, 1985 Mar 29, 1985 Jul 23, 1986 Jul 16, 1987 Jun Jul Sep Mar Mar Mar Feb Jan Oct Apr Dec Dec Sep Sep May Sep Sep Oct Jun Jun Dec Sep Oct Jul Jul Feb May Sep Sep Dec May Aug Aug Aug Jul Dec Jun Jun Jun Oct Feb 14, 25, 29, 23, 23, 23, 05, 20, 27, 29, 19, 19, 23, 23, 08, 19, 19, 15, 16, 16, 24, 26, 02, 24, 24, 18, 05, 24, 24, 03, 08, 06, 06, 06, 25, 08, 18, 18, 18, 03, 03, 1985 1986 1987 1987 1987 1987 1988 1987 1987 1988 1991 1991 1986 1986 1987 1986 1986 1986 1986 1986 1985 1986 1986 1985 1985 1987 1988 1985 1985 1987 1987 1985 1985 1985 1986 1987 1987 1987 1987 1986 1987

IBUPRIN PLIVA IBUPROFEN ABBOTT HALSEY

IVAX SUB TEVA PHARMS

LEDERLE LEINER MCNEIL MUTUAL PHARM

MYLAN

PAR PHARM

PERRIGO PLIVA

PUREPAC PHARM

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

IBUPROFEN
TABLET; ORAL IBUPROFEN PUREPAC PHARM

6 - 183 (of 346)

SANDOZ

SUPERPHARM TEVA

VINTAGE PHARMS WATSON LABS

300MG 400MG 600MG 800MG 200MG 200MG 200MG 200MG 300MG 400MG 400MG 600MG 600MG 800MG 800MG 600MG 200MG 400MG 600MG 800MG 200MG 200MG 200MG 300MG 400MG 600MG 800MG 800MG 400MG 800MG 200MG 200MG 200MG 200MG 300MG 400MG 600MG 800MG 100MG 200MG 200MG 200MG 200MG 600MG

A071123 A071124 A071125 A071964 A070733 A071807 A074525 A074533 A070734 A070735 A072064 A070736 A072065 A071938 A072169 A070709 A073141 A073343 A073344 A073345 A072249 A071765 A071905 A071338 A070038 A070041 A071547 A071911 A070469 A071965 A070475 A071215 A070591 A071001 N017463 N017463 N017463 N017463 N020418 A072035 A072036 N019012 N019012 N018197

001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 003 002 004 005 001 001 001 001 002 002

Sep Sep Sep Feb Sep Feb Dec Dec Jun Jun Jan Jun Jan Jan Dec Apr May Jun Jun Jun Jan Sep Mar Dec Sep Sep Jul Oct

19, 19, 19, 01, 19, 25, 15, 15, 12, 12, 14, 12, 14, 14, 11, 25, 29, 30, 30, 30, 10, 04, 08, 01, 06, 06, 02, 13,

1986 1986 1986 1988 1986 1988 1995 1995 1986 1986 1988 1986 1988 1988 1987 1986 1992 1992 1992 1992 1989 1987 1988 1986 1985 1985 1987 1987

IBUPROHM OHM LABS IBU-TAB ALRA MEDIPREN MCNEIL MIDOL BAYER MOTRIN MCNEIL CONSUMER

Aug 29, 1985 Aug 11, 1988 Feb 06, 1986 Jun 26, 1986 Sep 02, 1987 Sep 02, 1987

MCNEIL PED NUPRIN BRISTOL MYERS MCNEIL RUFEN BASF TABLET, CHEWABLE; ORAL MOTRIN MCNEIL PED

May 22, 1985 Nov 16, 1994 Feb Feb May Jul 16, 16, 18, 29, 1988 1988 1984 1987

Mar 05, 1984

50MG 100MG

N020135 N020135

001 002

Nov 16, 1994 Nov 16, 1994

IBUPROFEN; OXYCODONE HYDROCHLORIDE

TABLET; ORAL COMBUNOX FOREST LABS

400MG;5MG

N021378

001

Nov 26, 2004

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

IDARUBICIN HYDROCHLORIDE
INJECTABLE; INJECTION IDAMYCIN PHARMACIA AND UPJOHN

6 - 184 (of 346)

5MG/VIAL 10MG/VIAL 20MG/VIAL

N050661 N050661 N050661

002 001 003

Sep 27, 1990 Sep 27, 1990 Apr 25, 1995

IDOXURIDINE
OINTMENT; OPHTHALMIC STOXIL GLAXOSMITHKLINE 0.5% SOLUTION/DROPS; OPHTHALMIC STOXIL GLAXOSMITHKLINE 0.1%

N015868

001

N013934

001

IFOSFAMIDE; MESNA
INJECTABLE; INJECTION IFEX/MESNEX KIT BAXTER HLTHCARE

1GM/VIAL;100MG/ML 3GM/VIAL;100MG/ML

N019763 N019763

003 004

Oct 10, 1992 Oct 10, 1992

ILOPROST
SOLUTION; INHALATION VENTAVIS ACTELION PHARMS LTD

20MCG/2ML (10MCG/ML)

N021779

001

Dec 29, 2004

IMATINIB MESYLATE
CAPSULE; ORAL GLEEVEC NOVARTIS

EQ 50MG BASE EQ 100MG BASE

N021335 N021335

001 002

May 10, 2001 May 10, 2001

IMIPRAMINE HYDROCHLORIDE
CONCENTRATE; ORAL IMIPRAMINE HYDROCHLORIDE NOVARTIS 25MG/ML INJECTABLE; INJECTION TOFRANIL NOVARTIS 12.5MG/ML TABLET; ORAL IMIPRAMINE HYDROCHLORIDE ACTAVIS TOTOWA 10MG 25MG 50MG LEDERLE 10MG 25MG 50MG PAR PHARM 25MG 50MG ROXANE 10MG 25MG 50MG SANDOZ 10MG 25MG 50MG TEVA 10MG 25MG 50MG USL PHARMA 25MG VANGARD 10MG 25MG 50MG WATSON LABS 10MG

A086765

001

N011838

002

A040753 A040752 A040751 A086269 A086267 A086268 A089497 A088276 A083799 A083799 A083799 A085200 A084869 A085133 A083729 A083729 A083729 A087776 A088036 A087619 A087631 A085220

001 001 001 001 001 001 001 001 001 002 003 001 002 001 001 004 003 001 001 001 001 001

Feb 28, 2008 Feb 28, 2008 Feb 28, 2008

Jul 14, 1987 Oct 21, 1983

Feb Nov Feb Jan

10, 03, 09, 04,

1982 1982 1982 1982

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

IMIPRAMINE HYDROCHLORIDE
TABLET; ORAL IMIPRAMINE HYDROCHLORIDE WATSON LABS 10MG 25MG 25MG 50MG 50MG WEST WARD 25MG 50MG JANIMINE ABBOTT 10MG 25MG 50MG PRAMINE ALRA 10MG 25MG 50MG PRESAMINE SANOFI AVENTIS US 10MG 25MG 50MG

6 - 185 (of 346)

A085875 A084252 A085878 A085221 A085877 A088222 A088223 N017895 N017895 N017895 A083827 A083827 A083827 N011836 N011836 N011836

001 002 001 001 001 001 001 001 002 003 001 002 003 006 003 007

May 26, 1983 May 26, 1983

INAMRINONE LACTATE
INJECTABLE; INJECTION AMRINONE LACTATE BAXTER HLTHCARE CORP HOSPIRA INOCOR SANOFI AVENTIS US

EQ 5MG BASE/ML EQ 5MG BASE/ML EQ 5MG BASE/ML

A075542 A074616 N018700

001 001 001

May 10, 2000 Aug 03, 1998 Jul 31, 1984

INDAPAMIDE
TABLET; ORAL INDAPAMIDE CADISTA PHARMS TEVA

1.25MG 2.5MG 1.25MG 1.25MG 2.5MG 2.5MG 1.25MG 2.5MG

A075201 A075201 A074498 A074665 A074498 A074665 N018538 N018538

001 002 002 001 001 002 002 001

Dec Dec Feb Apr Oct Apr

04, 04, 12, 04, 31, 04,

1998 1998 1998 1997 1996 1997

LOZOL SANOFI AVENTIS US

Apr 29, 1993 Jul 06, 1983

INDECAINIDE HYDROCHLORIDE
TABLET, EXTENDED RELEASE; ORAL DECABID LILLY EQ 50MG BASE EQ 75MG BASE EQ 100MG BASE

N019693 N019693 N019693

001 002 003

Dec 29, 1989 Dec 29, 1989 Dec 29, 1989

INDINAVIR SULFATE
CAPSULE; ORAL CRIXIVAN MERCK SHARP DOHME

EQ 333MG BASE

N020685

005

Dec 17, 1998

INDOCYANINE GREEN
INJECTABLE; INJECTION IC-GREEN AKORN

10MG/VIAL 40MG/VIAL 50MG/VIAL

N011525 N011525 N011525

003 004 002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

INDOMETHACIN
CAPSULE; ORAL INDOCIN IROKO PHARMS INDO-LEMMON TEVA INDOMETHACIN ABLE

6 - 186 (of 346)

25MG 50MG 25MG 50MG

N016059 N016059 A070266 A070267 A076666 A076666 A070326 A070327 A070782 A070635 N018730 N018730 A070067 A070899 A070068 A070900 N018858 N018806 N018806 A070813 A070592 A071148 A071149 A070353 A070354 A070487 A070488 A071342 A071343 N018829 A070651 N018829 A070529 A070784 A072996 N018690 A070530 A070785 A071635 A072997 N018690

001 002 001 001 001 002 001 001 001 001 001 002 001 001 001 001 002 001 002 001 001 001 001 001 001 001 001 001 001 002 001 001 001 001 001 001 001 001 001 001 002 Nov 07, 1985 Nov 07, 1985 Dec Dec Oct Oct Jun Jun May May Oct Feb Oct Feb Apr Nov Nov Aug Aug Mar Mar Jun Jun Oct Oct Apr Apr Aug Mar Aug Oct Aug Jul Jul Oct Aug May Jul Jul 17, 17, 18, 18, 03, 03, 04, 04, 03, 09, 03, 09, 20, 23, 23, 11, 11, 18, 18, 18, 18, 10, 10, 18, 18, 06, 05, 06, 18, 20, 31, 31, 18, 20, 18, 31, 31, 2003 2003 1985 1985 1987 1987 1984 1984 1986 1987 1986 1987 1984 1984 1984 1986 1986 1987 1987 1985 1985 1986 1986 1988 1988 1984 1986 1984 1985 1986 1991 1984 1985 1986 1987 1991 1984

25MG 50MG DURAMED PHARMS BARR 25MG 50MG HALSEY 25MG 50MG IVAX SUB TEVA PHARMS 25MG 50MG MUTUAL PHARM 25MG 25MG 50MG 50MG MYLAN 50MG PARKE DAVIS 25MG 50MG PIONEER PHARMS 25MG 50MG PLIVA 25MG 50MG ROXANE 25MG 50MG SUPERPHARM 25MG 50MG TEVA 25MG 50MG VINTAGE 25MG 50MG 50MG WATSON LABS 25MG 25MG 25MG 25MG 50MG 50MG 50MG 50MG 50MG CAPSULE, EXTENDED RELEASE; ORAL INDOCIN SR IROKO PHARMS 75MG INDOMETHACIN ABLE 75MG INWOOD LABS 75MG SUPPOSITORY; RECTAL INDOCIN IROKO PHARMS 50MG SUSPENSION; ORAL INDOMETHACIN ROXANE 25MG/5ML

N018185 A076114 A072410

001 001 001

Feb 23, 1982 Feb 06, 2002 Mar 15, 1989

N017814

001

Aug 13, 1984

A071412

001

Mar 18, 1987

INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT

INJECTABLE; SUBCUTANEOUS NOVOLOG MIX 50/50 NOVO NORDISK INC

50 UNITS/ML;50 UNITS/ML

N021810

001

Aug 26, 2008

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DISCONTINUED DRUG PRODUCT LIST

INSULIN PORK
INJECTABLE; INJECTION

ILETIN I

LILLY INSULIN

NOVO NORDISK INC REGULAR INSULIN

NOVO NORDISK INC

6 - 187 (of 346)

500 UNITS/ML 40 UNITS/ML 100 UNITS/ML

N017931 N017926 N017926

001

001

003

INSULIN PURIFIED BEEF

INJECTABLE; INJECTION

REGULAR ILETIN II

LILLY

100 UNITS/ML

N018478

001

INSULIN PURIFIED PORK

INJECTABLE; INJECTION

ILETIN II

LILLY 500 UNITS/ML REGULAR ILETIN II (PORK)

LILLY 100 UNITS/ML REGULAR PURIFIED PORK INSULIN

NOVO NORDISK INC 100 UNITS/ML VELOSULIN

NOVO NORDISK INC 100 UNITS/ML

N018344 N018344 N018381 N018193

002

001

001

001

INSULIN PURIFIED PORK; INSULIN SUSP ISOPHANE PURIFIED PORK

INJECTABLE; INJECTION

INSULIN NORDISK MIXTARD (PORK)

NOVO NORDISK INC 30 UNITS/ML;70 UNITS/ML

N018195

001

INSULIN RECOMBINANT HUMAN

INJECTABLE; INJECTION HUMULIN BR LILLY VELOSULIN BR NOVO NORDISK INC POWDER; INHALATION EXUBERA PFIZER

100 UNITS/ML 100 UNITS/ML

N019529 N021028

001 001

Apr 28, 1986 Jul 19, 1999

1MG/INH 3MG/INH

N021868 N021868

001 002

Jan 27, 2006 Jan 27, 2006

INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN

INJECTABLE; INJECTION HUMULIN 50/50 LILLY

50 UNITS/ML;50 UNITS/ML

N020100

001

Apr 29, 1992

INSULIN RECOMBINANT PURIFIED HUMAN

INJECTABLE; INJECTION NOVOLIN R NOVO NORDISK INC VELOSULIN BR HUMAN NOVO NORDISK INC

100 UNITS/ML 100 UNITS/ML

N018778 N019450

001 001

Aug 30, 1983 May 30, 1986

INSULIN RECOMBINANT PURIFIED HUMAN; INSULIN SUSP ISOPHANE SEMISYNTHETIC PURIFIED HUMAN
INJECTABLE; INJECTION MIXTARD HUMAN 70/30 BAYER PHARMS NOVOLIN 70/30 NOVO NORDISK INC

30 UNITS/ML;70 UNITS/ML 30 UNITS/ML;70 UNITS/ML

N019585 N019441

001 001

Mar 11, 1988 Jul 11, 1986

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INSULIN SUSP ISOPHANE BEEF
INJECTABLE; INJECTION NPH INSULIN NOVO NORDISK INC

6 - 188 (of 346)

40 UNITS/ML 100 UNITS/ML

N017929 N017929

001 003

INSULIN SUSP ISOPHANE BEEF/PORK

INJECTABLE; INJECTION NPH ILETIN I (BEEF-PORK) LILLY 40 UNITS/ML 100 UNITS/ML

N017936 N017936

001 002

INSULIN SUSP ISOPHANE PURIFIED BEEF

INJECTABLE; INJECTION NPH ILETIN II LILLY

100 UNITS/ML

N018479

001

INSULIN SUSP ISOPHANE PURIFIED PORK

INJECTABLE; INJECTION INSULIN INSULATARD NPH NORDISK NOVO NORDISK INC 100 UNITS/ML NPH ILETIN II (PORK) LILLY 100 UNITS/ML NPH PURIFIED PORK ISOPHANE INSULIN NOVO NORDISK INC 100 UNITS/ML

N018194 N018345 N018623

001 001 001

INSULIN SUSP ISOPHANE SEMISYNTHETIC PURIFIED HUMAN

INJECTABLE; INJECTION INSULATARD NPH HUMAN NOVO NORDISK INC NOVOLIN N NOVO NORDISK INC

100 UNITS/ML 100 UNITS/ML

N019449 N019065

001 001

May 30, 1986 Jan 23, 1985

INSULIN SUSP PROTAMINE ZINC BEEF/PORK

INJECTABLE; INJECTION PROTAMINE ZINC & ILETIN I (BEEF-PORK) LILLY 40 UNITS/ML 100 UNITS/ML

N017932 N017932

001 002

INSULIN SUSP PROTAMINE ZINC PURIFIED BEEF

INJECTABLE; PROTAMINE LILLY PROTAMINE BRISTOL INJECTION ZINC AND ILETIN II 100 UNITS/ML ZINC INSULIN MYERS SQUIBB 40 UNITS/ML 100 UNITS/ML

N018476 N017928 N017928

001 001 003

INSULIN SUSP PROTAMINE ZINC PURIFIED PORK

INJECTABLE; INJECTION PROTAMINE ZINC AND ILETIN II (PORK) LILLY 100 UNITS/ML

N018346

001

INSULIN ZINC SUSP BEEF

INJECTABLE; INJECTION LENTE INSULIN NOVO NORDISK INC

40 UNITS/ML 100 UNITS/ML

N017998 N017998

001 003

INSULIN ZINC SUSP EXTENDED BEEF

INJECTABLE; INJECTION ULTRALENTE INSULIN NOVO NORDISK INC

100 UNITS/ML

N017997

003

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DISCONTINUED DRUG PRODUCT LIST

INSULIN ZINC SUSP EXTENDED PURIFIED BEEF
INJECTABLE; INJECTION ULTRALENTE NOVO NORDISK INC

6 - 189 (of 346)

100 UNITS/ML

N018385

001

INSULIN ZINC SUSP EXTENDED RECOMBINANT HUMAN

INJECTABLE; INJECTION HUMULIN U LILLY

40 UNITS/ML 100 UNITS/ML

N019571 N019571

001 002

Jun 10, 1987 Jun 10, 1987

INSULIN ZINC SUSP PROMPT BEEF

INJECTABLE; INJECTION SEMILENTE INSULIN NOVO NORDISK INC

100 UNITS/ML

N017996

003

INSULIN ZINC SUSP PROMPT PURIFIED PORK

INJECTABLE; INJECTION SEMILENTE NOVO NORDISK INC

100 UNITS/ML

N018382

001

INSULIN ZINC SUSP PURIFIED BEEF

INJECTABLE; INJECTION LENTE ILETIN II LILLY

100 UNITS/ML

N018477

001

INSULIN ZINC SUSP PURIFIED BEEF/PORK

INJECTABLE; INJECTION LENTARD NOVO NORDISK INC

100 UNITS/ML

N018384

001

INSULIN ZINC SUSP PURIFIED PORK

INJECTABLE; INJECTION LENTE NOVO NORDISK INC LENTE ILETIN II (PORK) LILLY

100 UNITS/ML 100 UNITS/ML

N018383 N018347

001 001

INSULIN ZINC SUSP RECOMBINANT HUMAN

INJECTABLE; INJECTION HUMULIN L LILLY NOVOLIN L NOVO NORDISK INC

100 UNITS/ML 100 UNITS/ML

N019377 N019965

002 001

Sep 30, 1985 Jun 25, 1991

INSULIN ZINC SUSP SEMISYNTHETIC PURIFIED HUMAN

INJECTABLE; INJECTION NOVOLIN L NOVO NORDISK INC

100 UNITS/ML

N018777

001

Aug 30, 1983

INULIN
INJECTABLE; INJECTION INULIN AND SODIUM CHLORIDE ISO TEX 100MG/ML

N002282

001

INVERT SUGAR
INJECTABLE; INJECTION TRAVERT 10% IN PLASTIC CONTAINER BAXTER HLTHCARE 10GM/100ML

N016717

001

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IOBENGUANE SULFATE I-131
INJECTABLE; INJECTION IOBENGUANE SULFATE I 131 PHARMALUCENCE 2.3mCi/ML

6 - 190 (of 346)

N020084

001

Mar 25, 1994

IOCETAMIC ACID
TABLET; ORAL CHOLEBRINE MALLINCKRODT

750MG

N017129

001

IODAMIDE MEGLUMINE
INJECTABLE; INJECTION RENOVUE-65 BRACCO RENOVUE-DIP BRACCO

65% 24%

N017902 N017903

001 001

IODIPAMIDE MEGLUMINE
INJECTABLE; INJECTION CHOLOGRAFIN MEGLUMINE BRACCO

10.3%

N009321

007

IODIPAMIDE SODIUM
INJECTABLE; INJECTION CHOLOGRAFIN SODIUM BRACCO

20%

N009321

001

IODOHIPPURATE SODIUM I-123

INJECTABLE; INJECTION NEPHROFLOW GE HEALTHCARE

1mCi/ML

N018289

001

Dec 28, 1984

IODOHIPPURATE SODIUM I-131

INJECTABLE; INJECTION HIPPURAN I 131 MALLINCKRODT 0.25mCi/ML HIPPUTOPE BRACCO 1-2mCi/VIAL IODOHIPPURATE SODIUM I 131 PHARMALUCENCE 0.2mCi/ML

N016666 N015419 N017313

001 002 001

IODOXAMATE MEGLUMINE
INJECTABLE; INJECTION CHOLOVUE BRACCO

9.9% 40.3%

N018077 N018076

001 001

IOFETAMINE HYDROCHLORIDE I-123

INJECTABLE; INJECTION SPECTAMINE IMP

1mCi/ML

N019432

001

Dec 24, 1987

IOHEXOL
INJECTABLE; INJECTION OMNIPAQUE 210 GE HEALTHCARE SOLUTION; URETHRAL OMNIPAQUE 70 GE HEALTHCARE

45.3%

N018956

006

Jun 30, 1989

15.1%

N018956

007

Jun 01, 1994

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IOPAMIDOL
INJECTABLE; INJECTION IOPAMIDOL BAXTER HLTHCARE

6 - 191 (of 346)

HOSPIRA

41% 51% 61% 76% 61% 76%

A074629 A074629 A074629 A074629 A074734 A074734 A074881 A074898 A074636 A074881 A074898 A075005 A074636 A074638 A074881 A074898 A075005 A074636 A074637 A074881 A074898 A075005 A074636 N018735 N020327

001 004 002 003 001 002 001 001 001 002 002 001 002 001 003 003 002 003 001 004 004 003 004 005 001

Nov Mar Nov Nov Dec Dec

06, 31, 06, 06, 10, 10,

1996 1998 1996 1996 1996 1996

IOPAMIDOL-200 COOK IMAGING 41% HOSPIRA 41% IOPAMIDOL-200 IN PLASTIC CONTAINER HOSPIRA 41% IOPAMIDOL-250 COOK IMAGING 51% HOSPIRA 51% 51% IOPAMIDOL-250 IN PLASTIC CONTAINER HOSPIRA 51% IOPAMIDOL-300 ABBOTT 61% COOK IMAGING 61% HOSPIRA 61% 61% IOPAMIDOL-300 IN PLASTIC CONTAINER HOSPIRA 61% 61% IOPAMIDOL-370 COOK IMAGING 76% HOSPIRA 76% 76% IOPAMIDOL-370 IN PLASTIC CONTAINER HOSPIRA 76% ISOVUE-128 BRACCO 26% ISOVUE-200 BRACCO 41%

Jul 28, 2000 Dec 30, 1997 Dec 30, 1997 Jul 28, 2000 Dec 30, 1997 Feb 24, 1998 Dec 30, 1997 Apr Jul Dec Feb 30, 28, 30, 24, 1997 2000 1997 1998

Dec 30, 1997 Apr 03, 1997 Jul 28, 2000 Dec 30, 1997 Feb 24, 1998 Dec 30, 1997 Oct 21, 1986 Oct 12, 1994

IOPANOIC ACID
TABLET; ORAL TELEPAQUE GE HEALTHCARE

500MG

N008032

001

IOPHENDYLATE
INJECTABLE; INJECTION PANTOPAQUE ALCON

100%

N005319

001

IOTHALAMATE MEGLUMINE; IOTHALAMATE SODIUM

INJECTABLE; INJECTION VASCORAY MALLINCKRODT

52%;26%

N016783

001

IOTHALAMATE SODIUM
INJECTABLE; INJECTION ANGIO-CONRAY MALLINCKRODT CONRAY 325 MALLINCKRODT CONRAY 400 MALLINCKRODT

80% 54.3% 66.8%

N013319 N017685 N014295

001 001 001

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IOTHALAMATE SODIUM I-125
INJECTABLE; INJECTION GLOFIL-125 ISOTEX

6 - 192 (of 346)

250-300uCi/ML

N017279

001

IOTROLAN
INJECTABLE; INTRATHECAL OSMOVIST 190 BAYER HLTHCARE OSMOVIST 240 BAYER HLTHCARE

40.6% 51.3%

N019580 N019580

001 002

Dec 07, 1989 Dec 07, 1989

IOVERSOL
INJECTABLE; INJECTION OPTIRAY 160 MALLINCKRODT OPTIRAY 240 MALLINCKRODT OPTIRAY 320 MALLINCKRODT

34% 51% 68%

N019710 N020923 N020923

003 001 002

Dec 30, 1988 May 28, 1998 May 29, 1998

IPODATE CALCIUM
GRANULE; ORAL ORAGRAFIN CALCIUM BRACCO

3GM/PACKET

N012968

001

IPODATE SODIUM
CAPSULE; ORAL BILIVIST BAYER HLTHCARE ORAGRAFIN SODIUM BRACCO

500MG 500MG

A087768 N012967

001 001

Aug 11, 1982

IPRATROPIUM BROMIDE
AEROSOL, METERED; INHALATION ATROVENT BOEHRINGER INGELHEIM 0.018MG/INH SOLUTION; INHALATION ATROVENT BOEHRINGER INGELHEIM 0.02% IPRATROPIUM BROMIDE ACTAVIS MID ATLANTIC 0.02% PHARMASCIENCE INC 0.02% ROXANE 0.02%

N019085

001

Dec 29, 1986

N020228 A075111 A075507 A075867

001 001 001 001

Sep 29, 1993 Apr 22, 1999 Jan 19, 2001 Jul 22, 2002

IRINOTECAN HYDROCHLORIDE
INJECTABLE; INJECTION IRINOTECAN HYDROCHLORIDE SANDOZ 40MG/2ML (20MG/ML) 100MG/5ML (20MG/ML)

A077994 A077994

001 002

Feb 27, 2008 Feb 27, 2008

IRON DEXTRAN
INJECTABLE; INJECTION IRON DEXTRAN SANOFI AVENTIS US

EQ 50MG IRON/ML

N010787

002

IRON SUCROSE
INJECTABLE; INTRAVENOUS VENOFER LUITPOLD

EQ 75MG BASE/3.75ML (EQ 20MG BASE/ML)

N021135

003

Mar 29, 2005

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ISOETHARINE HYDROCHLORIDE
SOLUTION; INHALATION BETA-2 NEPHRON BRONKOSOL SANOFI AVENTIS US

6 - 193 (of 346)

1%

A086711 N012339 N012339 A087101 A087937 A089614 A087938 A089615 A088470 A089616 A088471 A089617 A088472 A089618 A088144 A088145 A088146 A088187 A087389 A087390 A088188 A086763 A086651 A086651 A086651 A086651 A086651 A086651 A086651 A086651 A085997 A085889 A087396 A087025 A088226 A087324 A088275 A086899 A089817 A089818 A089819 A089820 A089252

001 009 008 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 002 003 004 005 006 007 008 001 001 001 001 001 001 001 001 001 001 001 001 001

0.25% 1% ISOETHARINE HYDROCHLORIDE ALPHARMA US PHARMS 1% ASTRAZENECA 0.062% 0.062% 0.125% 0.125% 0.167% 0.167% 0.2% 0.2% 0.25% 0.25% BAXTER HLTHCARE 0.08% 0.14% 0.25% DEY 0.08% 0.1% 0.17% 0.25% 1% INTL MEDICATION 0.077% 0.08% 0.1% 0.143% 0.167% 0.2% 0.25% 1% PARKE DAVIS 0.5% 1% ROXANE 0.1% 0.125% 0.167% 0.2% 0.25% 1% ISOETHARINE HYDROCHLORIDE S/F DEY 0.08% 0.1% 0.17% 0.25% 1%

Nov Jun Nov Jun Mar Jun Mar Jun Mar Jun Jul Mar Aug Dec

15, 13, 15, 13, 14, 13, 14, 13, 14, 13, 29, 26, 01, 03,

1982 1991 1982 1991 1984 1991 1984 1991 1984 1991 1983 1984 1983 1982

Dec 03, 1982

Sep 16, 1983 Jun 03, 1983

Nov Nov Nov Nov Sep

22, 22, 22, 22, 15,

1988 1988 1988 1988 1986

ISOETHARINE MESYLATE
AEROSOL, METERED; INHALATION BRONKOMETER SANOFI AVENTIS US 0.34MG/INH ISOETHARINE MESYLATE ALPHARMA US PHARMS 0.34MG/INH

N012339 A087858

007 001 Aug 21, 1984

ISOFLURANE
LIQUID; INHALATION ISOFLURANE MARSAM PHARMS LLC

99.9%

A074393

001

May 12, 1995

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ISOFLUROPHATE
OINTMENT; OPHTHALMIC FLOROPRYL MERCK

6 - 194 (of 346)

0.025%

N010656

001

ISONIAZID
INJECTABLE; INJECTION NYDRAZID SANDOZ RIMIFON ROCHE SYRUP; ORAL ISONIAZID MIKART LANIAZID LANNETT RIMIFON ROCHE TABLET; ORAL DOW-ISONIAZID DOW PHARM HYZYD MEDPOINTE PHARM HLC INH NOVARTIS ISONIAZID DURAMED PHARMS BARR HALSEY IMPAX LABS IVAX SUB TEVA PHARMS LILLY MK LABS MUTUAL PHARM NEXGEN PHARMA INC PANRAY

100MG/ML 25MG/ML 100MG/ML

N008662 N008420 N008420

001 002 003

50MG/5ML 50MG/5ML 50MG/5ML

A081118 A089243 N008420

001 001 001

Jul 21, 1997 Feb 03, 1986

300MG 100MG 300MG 300MG 100MG 300MG 50MG 100MG 100MG 300MG 100MG 300MG 100MG 100MG 300MG 100MG 50MG 100MG 300MG 100MG 100MG 50MG 100MG 50MG 100MG 50MG 100MG 100MG 100MG 300MG 300MG 100MG 50MG 100MG 300MG 100MG

A080330 A080134 A080134 A080935 A088231 A088119 A083632 A080153 A080270 A083610 N008499 N008499 A080941 A080136 A083633 A084050 N008428 N008428 N008428 A083060 A085091 A080368 A080368 A080132 A080132 A080522 A080401 A080523 A085790 A083178 A085784 A080120 A080140 A080140 A089776 N008392

002 003 004 001 001 001 001 001 001 001 002 003 001 001 001 001 001 002 003 001 001 001 002 003 004 001 001 001 001 001 001 002 001 002 001 003 Mar 17, 1983 Mar 17, 1983

PERRIGO PHARMAVITE PHOENIX LABS NY PUREPAC PHARM WATSON LABS

Jul 14, 1982 Jul 14, 1982

WHITEWORTH TOWN PLSN LANIAZID LANNETT

Jun 13, 1988

NYDRAZID BRISTOL MYERS SQUIBB

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ISONIAZID
TABLET; ORAL STANOZIDE EVERYLIFE

6 - 195 (of 346)

100MG 300MG

A080126 A080126

001 002

ISOPROPAMIDE IODIDE
TABLET; ORAL DARBID GLAXOSMITHKLINE

EQ 5MG BASE

N010744

001

ISOPROTERENOL HYDROCHLORIDE
AEROSOL, METERED; INHALATION ISOPROTERENOL HYDROCHLORIDE 3M 0.12MG/INH ALPHARMA US PHARMS 0.12MG/INH ISUPREL SANOFI AVENTIS US 0.103MG/INH DISC; INHALATION NORISODRINE AEROTROL ABBOTT 0.25% INJECTABLE; INJECTION ISOPROTERENOL HYDROCHLORIDE ABRAXIS PHARM 0.2MG/ML BAXTER HLTHCARE 0.2MG/ML HOSPIRA 0.02MG/ML 0.2MG/ML SOLUTION; INHALATION AEROLONE LILLY 0.25% ISOPROTERENOL HYDROCHLORIDE ARMOUR PHARM 0.031% 0.062% DEY 0.5% PARKE DAVIS 0.25% 0.5% ISUPREL SANOFI AVENTIS US 0.5% 1% VAPO-ISO FISONS 0.5% TABLET; RECTAL, SUBLINGUAL ISUPREL SANOFI AVENTIS US 10MG 15MG

N010375 A085904 N011178

004 001 001

N016814

001

A083431 A083486 A083283 A083346

001 001 001 001

N007245 A087935 A087936 A086764 A085994 A085540 N006327 N006327 N016813

001 001 001 001 001 001 002 003 001 Nov 18, 1982 Nov 18, 1982 Jan 04, 1982

N006328 N006328

001 002

ISOPROTERENOL HYDROCHLORIDE; PHENYLEPHRINE BITARTRATE

AEROSOL, METERED; INHALATION DUO-MEDIHALER 3M 0.16MG/INH;0.24MG/INH

N013296

001

ISOPROTERENOL SULFATE
AEROSOL, METERED; INHALATION MEDIHALER-ISO 3M 0.08MG/INH POWDER; INHALATION NORISODRINE ABBOTT 10% 25%

N010375

003

N006905 N006905

003 002

ISOSORBIDE
SOLUTION; ORAL ISMOTIC ALCON

100GM/220ML

N017063

001

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ISOSORBIDE DINITRATE
CAPSULE, EXTENDED RELEASE; ORAL ISORDIL WYETH AYERST 40MG TABLET; ORAL ISOSORBIDE DINITRATE MUTUAL PHARM 5MG 10MG 20MG 30MG SUPERPHARM 5MG 10MG 20MG SORBITRATE ASTRAZENECA 5MG 10MG 20MG 30MG 40MG TABLET; SUBLINGUAL ISORDIL BIOVAIL 2.5MG 5MG 10MG ISOSORBIDE DINITRATE MUTUAL PHARM 2.5MG 5MG 10MG SANDOZ 2.5MG 5MG SORBITRATE ASTRAZENECA 2.5MG 5MG TABLET, CHEWABLE; ORAL SORBITRATE ASTRAZENECA 5MG 10MG TABLET, EXTENDED RELEASE; ORAL ISORDIL WYETH AYERST 40MG

6 - 196 (of 346)

N012882

002

Jul 29, 1988

A086166 A086169 A086167 A087564 A089190 A089191 A089192 N016192 N016192 A086405 A088124 A088125

002 001 001 001 001 001 001 001 002 002 001 001

Sep Sep Sep Sep Feb Feb Feb Apr Apr Aug Aug Aug

19, 19, 19, 18, 17, 17, 17, 01, 01, 21, 21, 21,

1986 1986 1986 1986 1987 1987 1987 1996 1996 1990 1990 1990

N012940 N012940 N012940 A084204 A086168 A087545 A086225 A086222 N016191 N016191

004 003 005 001 001 001 001 001 002 001

Jul 29, 1988 Jul 29, 1988 Jul 29, 1988 Sep Sep Sep Feb Feb 18, 18, 18, 19, 19, 1986 1986 1986 1988 1988

Apr 01, 1996 Apr 01, 1996

N016776 N016776

002 003

Apr 01, 1996 Apr 01, 1996

N012882

001

Jul 29, 1988

ISOSORBIDE MONONITRATE
TABLET; ORAL ISMO PROMIUS PHARMA 20MG TABLET, EXTENDED RELEASE; ORAL IMDUR SCHERING PLOUGH 30MG 60MG 120MG ISOSORBIDE MONONITRATE IVAX SUB TEVA PHARMS 30MG 60MG 120MG

N019091

001

Dec 30, 1991

N020225 N020225 N020225 A075448 A075448 A075448

001 002 003 002 001 003

Aug 12, 1993 Aug 12, 1993 Mar 30, 1995 Aug 07, 2001 Jun 19, 2000 Aug 07, 2001

ISOTRETINOIN
CAPSULE; ORAL ACCUTANE HOFFMANN LA ROCHE

10MG 20MG 40MG

N018662 N018662 N018662

002 004 003

May 07, 1982 Mar 28, 1983 May 07, 1982

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ISRADIPINE
CAPSULE; ORAL DYNACIRC SMITHKLINE BEECHAM

6 - 197 (of 346)

2.5MG 5MG

N019546 N019546

001 002

Dec 20, 1990 Dec 20, 1990

ITRACONAZOLE
INJECTABLE; INJECTION SPORANOX JANSSEN PHARMS

10MG/ML

N020966

001

Mar 30, 1999

IVERMECTIN
TABLET; ORAL STROMECTOL MERCK

6MG

N050742

001

Nov 22, 1996

KANAMYCIN SULFATE
CAPSULE; ORAL KANTREX APOTHECON

EQ 500MG BASE EQ 500MG BASE EQ 500MG BASE

A060516 A061911 A062726

001 001 001

Mar 06, 1987

INJECTABLE; INJECTION KANAMYCIN BAXTER HLTHCARE

EQ 75MG BASE/2ML EQ 500MG BASE/2ML EQ 1GM BASE/3ML EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ 75MG BASE/2ML 500MG BASE/2ML 1GM BASE/3ML 500MG BASE/2ML 1GM BASE/3ML 75MG BASE/2ML 500MG BASE/2ML 1GM BASE/3ML 75MG BASE/2ML 500MG BASE/2ML 1GM BASE/3ML 75MG BASE/2ML 500MG BASE/2ML 1GM BASE/3ML 1GM BASE/3ML 1GM BASE/3ML 75MG BASE/2ML 75MG BASE/2ML 75MG BASE/2ML 500MG BASE/2ML 500MG BASE/2ML 500MG BASE/2ML 1GM BASE/3ML 1GM BASE/3ML 1GM BASE/3ML

A062324 A062324 A062324 A062504 A062504 A062504 A062466 A062466 A063021 A063022 A063025 A062668 A062672 A062669 A062605 A062605 A062605 A063092 A062520 A061655 A061901 A062564 A061655 A061901 A062564 A061655 A061901 A062564 A062170 A062170 A062170

001 002 003 001 002 003 001 002 001 001 001 001 001 001 003 001 002 001 003 003 003 001 001 001 002 002 002 003 001 002 003 Apr Apr Apr Sep Sep Jul Jul Jul May May May Feb Feb Feb Oct May 05, 05, 05, 30, 30, 31, 31, 31, 07, 07, 07, 26, 26, 26, 11, 09, 1984 1984 1984 1983 1983 1992 1992 1992 1987 1987 1987 1986 1986 1986 1989 1985

KANAMYCIN SULFATE ABRAXIS PHARM

INTL MEDICATION LOCH

PHARMAFAIR

SOLOPAK

WARNER CHILCOTT WATSON LABS KANTREX APOTHECON

Sep 21, 1984

Sep 21, 1984

Sep 21, 1984

KLEBCIL KING PHARMS

EQ 75MG BASE/2ML EQ 500MG BASE/2ML EQ 1GM BASE/3ML

KETOCONAZOLE
CREAM; TOPICAL NIZORAL JANSSEN PHARMA

2%

N019084

001

Dec 31, 1985

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

KETOCONAZOLE
SUSPENSION; ORAL NIZORAL JANSSEN PHARMA TABLET; ORAL KETOCONAZOLE AAIPHARMA LLC TEVA

6 - 198 (of 346)

100MG/5ML

A070767

001

Nov 07, 1986

200MG 200MG

A075341 A074971

001 001

Jul 27, 1999 Jun 15, 1999

KETOPROFEN
CAPSULE; ORAL KETOPROFEN SANDOZ TEVA ORUDIS WYETH AYERST

50MG 75MG 25MG

A074024 A074024 A073515 N018754 N018754 N018754

001 002 001 001 002 003

Dec 29, 1995 Dec 29, 1995 Dec 22, 1992 Jul 31, 1987 Jan 09, 1986 Jan 09, 1986

25MG 50MG 75MG CAPSULE, EXTENDED RELEASE; ORAL ORUVAIL WYETH PHARMS INC 100MG 150MG 200MG TABLET; ORAL ACTRON BAYER 12.5MG KETOPROFEN PERRIGO 12.5MG ORUDIS KT WYETH CONS 12.5MG

N019816 N019816 N019816

003 002 001

Feb 08, 1995 Feb 08, 1995 Sep 24, 1993

N020499 A075364 N020429

001 001 001

Oct 06, 1995 Feb 07, 2002 Oct 06, 1995

KETOROLAC TROMETHAMINE
INJECTABLE; INJECTION KETOROLAC TROMETHAMINE AMPHASTAR PHARM APOTEX INC APOTHECON BEDFORD GLAND PHARMA LTD HOSPIRA TORADOL ROCHE PALO TABLET; ORAL KETOROLAC TROMETHAMINE ROXANE WATSON LABS TORADOL ROCHE PALO

15MG/ML 30MG/ML 30MG/ML 30MG/ML 15MG/ML 30MG/ML 15MG/ML 30MG/ML 15MG/ML 30MG/ML 15MG/ML 30MG/ML 15MG/ML 30MG/ML

A076209 A076209 A075626 A077201 A075348 A075348 A075230 A075230 A076722 A076722 A074801 A074801 N019698 N019698

001 002 001 001 001 002 002 001 001 002 001 002 001 002

Jul Jul Jul Oct Nov Nov Oct Oct Jul Jul Jun Jun

21, 21, 24, 14, 28, 28, 25, 25, 27, 27, 05, 05,

2004 2004 2001 2005 2000 2000 1999 1999 2004 2004 1997 1997

Nov 30, 1989 Nov 30, 1989

10MG 10MG 10MG

A074790 A074955 N019645

001 001 001

Jun 26, 1997 Sep 19, 1997 Dec 20, 1991

KRYPTON, KR-81M
GAS; INHALATION MPI KRYPTON 81M GENERATOR GE HEALTHCARE N/A

N018088

001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

LABETALOL HYDROCHLORIDE
INJECTABLE; INJECTION LABETALOL HYDROCHLORIDE APOTHECON HOSPIRA NORMODYNE SCHERING TRANDATE PROMETHEUS LABS TABLET; ORAL LABETALOL HYDROCHLORIDE APOTHECON

6 - 199 (of 346)

5MG/ML 5MG/ML 5MG/ML 5MG/ML

A075355 A075242 N018686 N019425

001 001 001 001

Nov 29, 1999 Sep 30, 1999 Aug 01, 1984 Dec 31, 1985

MUTUAL PHARM

TEVA

100MG 200MG 300MG 100MG 200MG 300MG 100MG 200MG 300MG 100MG 200MG 300MG 400MG 300MG 400MG

A075223 A075223 A075223 A075215 A075215 A075215 A074989 A074989 A074989 N018687 N018687 N018687 N018687 N018716 N018716

001 002 003 001 002 003 001 002 003 001 002 003 004 003 004

Nov Nov Nov Jul Jul Jul Sep Sep Sep Aug Aug Aug Aug

20, 20, 20, 29, 29, 29, 30, 30, 30, 31, 01, 01, 01,

1998 1998 1998 1999 1999 1999 1998 1998 1998 1987 1984 1984 1984

NORMODYNE SCHERING

TRANDATE PROMETHEUS LABS

Aug 01, 1984 Aug 01, 1984

LACTULOSE
SOLUTION; ORAL CHRONULAC SANOFI AVENTIS US DUPHALAC SOLVAY EVALOSE TEVA PHARMS LACTULOSE MORTON GROVE PACO LAXILOSE NOSTRUM LABS SOLUTION; ORAL, RECTAL ACILAC NOSTRUM LABS CEPHULAC SANOFI AVENTIS US GENERLAC MORTON GROVE HEPTALAC TEVA PHARMS LACTULOSE PACO ROXANE SOLVAY PORTALAC SOLVAY

10GM/15ML 10GM/15ML 10GM/15ML 10GM/15ML 10GM/15ML 10GM/15ML

N017884 A072372 A073497 A071841 A073160 A073686

001 001 001 001 001 001 Mar 22, 1989 May 28, 1993 Sep 22, 1988 Aug 25, 1992 May 28, 1993

10GM/15ML 10GM/15ML 10GM/15ML 10GM/15ML 10GM/15ML 10GM/15ML 10GM/15ML 10GM/15ML

A073685 N017657 A071842 A073504 A072029 A073590 N017906 A072374

001 001 001 001 001 001 001 001

May 28, 1993

Sep 27, 1988 May 28, 1993 Aug 25, 1992 May 29, 1992

Mar 22, 1989

LAMOTRIGINE
TABLET; ORAL LAMICTAL GLAXOSMITHKLINE

50MG 250MG

N020241 N020241

006 004

Dec 27, 1994 Dec 27, 1994

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

LAMOTRIGINE
TABLET; ORAL LAMOTRIGINE MATRIX LABS LTD

6 - 200 (of 346)

MYLAN

ROXANE

WOCKHARDT

25MG 100MG 150MG 200MG 25MG 100MG 150MG 200MG 25MG 100MG 150MG 200MG 25MG 100MG 150MG 200MG

A078443 A078443 A078443 A078443 A077428 A077428 A077428 A077428 A077392 A077392 A077392 A077392 A078982 A078982 A078982 A078982

001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004

Feb Feb Feb Feb Jan Jan Jan Jan Jan Jan Jan Jan Jan Jan Jan Jan

11, 11, 11, 11, 27, 27, 27, 27, 27, 27, 27, 27, 27, 27, 27, 27,

2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009

TABLET, CHEWABLE; ORAL LAMICTAL CD GLAXOSMITHKLINE LAMOTRIGINE SANDOZ

100MG 5MG 25MG

N020764 A078409 A078409

003 002 003

Aug 24, 1998 Jan 22, 2009 Jan 22, 2009

LANSOPRAZOLE
FOR SUSPENSION, DELAYED RELEASE; ORAL PREVACID TAKEDA PHARMS NA 15MG/PACKET 30MG/PACKET INJECTABLE; INTRAVENOUS PREVACID IV TAKEDA PHARMS NA 30MG/VIAL

N021281 N021281

001 002

May 03, 2001 May 03, 2001

N021566

001

May 27, 2004

LANSOPRAZOLE; NAPROXEN
CAPSULE, DELAYED REL PELLETS, TABLET; ORAL PREVACID NAPRAPAC 250 (COPACKAGED) TAKEDA PHARMS NA 15MG,N/A;N/A,250MG PREVACID NAPRAPAC 375 (COPACKAGED) TAKEDA PHARMS NA 15MG,N/A;N/A,375MG PREVACID NAPRAPAC 500 (COPACKAGED) TAKEDA PHARMS NA 15MG,N/A;N/A,500MG

N021507 N021507 N021507

002 003 004

Nov 14, 2003 Nov 14, 2003 Nov 14, 2003

LANTHANUM CARBONATE
TABLET, CHEWABLE; ORAL FOSRENOL SHIRE

EQ 250MG BASE

N021468

001

Oct 26, 2004

LAPYRIUM CHLORIDE; UNDECOYLIUM CHLORIDE IODINE COMPLEX

SOLUTION; TOPICAL VIRAC REX CHESEBROUGH PONDS

0.5%;1.8%

N011914

001

LEFLUNOMIDE
TABLET; ORAL LEFLUNOMIDE SANDOZ

10MG 20MG

A077085 A077085

001 002

Sep 13, 2005 Sep 13, 2005

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

LETROZOLE
TABLET; ORAL LETROZOLE SYNTHON PHARMS

6 - 201 (of 346)

2.5MG

A090196

001

Jun 03, 2011

LEUCOVORIN CALCIUM
FOR SOLUTION; ORAL LEUCOVORIN CALCIUM HOSPIRA INJECTABLE; INJECTION LEUCOVORIN CALCIUM ABIC

EQ 60MG BASE/VIAL

N008107

003

Jan 30, 1987

EQ 3MG BASE/ML EQ 50MG BASE/VIAL EQ 50MG BASE/VIAL ABRAXIS PHARM ELKINS SINN EQ 50MG BASE/VIAL EQ 100MG BASE/VIAL EQ 3MG BASE/ML HOSPIRA EQ 50MG BASE/VIAL EQ 100MG BASE/VIAL EQ 350MG BASE/VIAL PHARMACHEMIE EQ 350MG BASE/VIAL PHARMACHEMIE USA EQ 50MG BASE/VIAL EQ 100MG BASE/VIAL LEUCOVORIN CALCIUM PRESERVATIVE FREE EQ 10MG BASE/ML HOSPIRA EQ 10MG BASE/ML TEVA PARENTERAL WELLCOVORIN EQ 5MG BASE/ML GLAXOSMITHKLINE EQ 25MG BASE/VIAL EQ 50MG BASE/VIAL EQ 100MG BASE/VIAL TABLET; ORAL LEUCOVORIN CALCIUM EQ 5MG BASE COREPHARMA EQ 25MG BASE EQ 5MG BASE PAR PHARM EQ 25MG BASE EQ 5MG BASE PHARMACHEMIE EQ 25MG BASE EQ 15MG BASE SANDOZ EQ 5MG BASE XANODYNE PHARM EQ 10MG BASE EQ 15MG BASE WELLCOVORIN EQ 5MG BASE GLAXOSMITHKLINE EQ 25MG BASE

A089352 A089353 A088939 A070480 A081224 N008107 N008107 N008107 N008107 A040262 A089628 A089915 A040147 A040332 A087439 A089833 A089465 A089834

001 001 001 001 001 001 002 004 005 001 001 001 001 001 001 001 001 001

Jun Jun Dec Jan Jun

01, 01, 01, 02, 03,

1988 1988 1986 1987 1994

May Apr Dec Apr Apr

23, 05, 15, 17, 17,

1988 1989 1999 1997 1997

Jun 25, 1997 Jun 28, 1999 Oct Jan Jan Jan 19, 23, 23, 23, 1982 1989 1989 1989

A074544 A074544 A071600 A071598 A073099 A073101 A075327 N018459 A071962 A071104 N018342 N018342

001 002 001 001 001 001 001 001 001 001 001 002

Aug Aug Oct Oct Mar Mar Mar Jan Nov Mar

28, 28, 14, 14, 28, 28, 24, 30, 19, 04,

1997 1997 1987 1987 1997 1997 1999 1986 1987 1987

Jul 08, 1983 Jul 08, 1983

LEUPROLIDE ACETATE
IMPLANT; IMPLANTATION VIADUR ORTHO MCNEIL JANSSEN INJECTABLE; INJECTION LEUPROLIDE ACETATE GENZYME LUPRON ABBOTT LABS LUPRON DEPOT-PED ABBOTT ENDOCRINE

EQ 65MG BASE

N021088

001

Mar 03, 2000

1MG/0.2ML 1MG/0.2ML 3.75MG/VIAL,7.5MG/VIAL 7.5MG/VIAL,7.5MG/VIAL

A075721 N019010 N020263 N020263

001 001 003 004

Nov 29, 2001 Apr 09, 1985 Apr 16, 1993 Apr 16, 1993

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

LEVALLORPHAN TARTRATE
INJECTABLE; INJECTION LORFAN ROCHE

6 - 202 (of 346)

1MG/ML

N010423

001

LEVAMISOLE HYDROCHLORIDE
TABLET; ORAL ERGAMISOL JANSSEN PHARMA

EQ 50MG BASE

N020035

001

Jun 18, 1990

LEVETIRACETAM
TABLET; ORAL LEVETIRACETAM MYLAN

WATSON LABS FLORIDA

250MG 500MG 750MG 1GM 250MG 500MG 750MG

A078731 A078731 A078731 A078731 A077408 A077408 A077408

001 002 003 004 001 002 003

Feb Feb Feb Feb Mar Mar Mar

10, 10, 10, 10, 02, 02, 02,

2009 2009 2009 2009 2009 2009 2009

LEVOBETAXOLOL HYDROCHLORIDE
SUSPENSION/DROPS; OPHTHALMIC BETAXON ALCON PHARMS LTD EQ 0.5% BASE

N021114

001

Feb 23, 2000

LEVOBUPIVACAINE HYDROCHLORIDE
INJECTABLE; INJECTION CHIROCAINE PURDUE PHARMA LP

EQ 2.5MG BASE/ML EQ 5MG BASE/ML EQ 7.5MG BASE/ML

N020997 N020997 N020997

001 002 003

Aug 05, 1999 Aug 05, 1999 Aug 05, 1999

LEVOCABASTINE HYDROCHLORIDE
SUSPENSION/DROPS; OPHTHALMIC LIVOSTIN NOVARTIS EQ 0.05% BASE

N020219

001

Nov 10, 1993

LEVOCARNITINE
SOLUTION; ORAL CARNITOR SIGMA TAU

1GM/10ML

N018948

002

Apr 27, 1988

LEVODOPA
CAPSULE; ORAL BENDOPA VALEANT PHARM INTL

100MG 250MG 500MG 100MG 250MG 500MG 100MG 250MG 500MG

N016948 N016948 N016948 N016913 N016913 N016913 N016912 N016912 N016912

003 001 002 003 001 002 002 001 006

DOPAR SHIRE

LARODOPA ROCHE

TABLET; ORAL DOPAR SHIRE LARODOPA ROCHE

250MG 500MG 100MG

N016913 N016913 N016912

004 005 005

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

LEVODOPA
TABLET; ORAL LARODOPA ROCHE

6 - 203 (of 346)

250MG 500MG

N016912 N016912

003 004

LEVOMEPROMAZINE
INJECTABLE; INJECTION LEVOPROME IMMUNEX

20MG/ML

N015865

001

LEVOMETHADYL ACETATE HYDROCHLORIDE

CONCENTRATE; ORAL ORLAAM ROXANE

10MG/ML

N020315

001

Jul 09, 1993

LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE

INJECTABLE; INJECTION ARESTOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN SOLVAY 0.05MG/ML;2% CARBOCAINE W/ NEO-COBEFRIN EASTMAN KODAK 0.05MG/ML;2% MEPIVACAINE HYDROCHLORIDE W/ LEVONORDEFRIN GRAHAM CHEM 0.05MG/ML;2% POLOCAINE W/ LEVONORDEFRIN DENTSPLY PHARM 0.05MG/ML;2%

A085010 N012125 A084850 A089517

001 002 002 001 Oct 21, 1983 Apr 14, 1988

LEVONORDEFRIN; PROCAINE HYDROCHLORIDE; PROPOXYCAINE HYDROCHLORIDE

INJECTABLE; INJECTION RAVOCAINE AND NOVOCAIN W/ NEO-COBEFRIN EASTMAN KODAK 0.05MG/ML;2%;0.4%

N008592

007

LEVONORGESTREL
IMPLANT; IMPLANTATION LEVONORGESTREL WYETH PHARMS INC 75MG/IMPLANT NORPLANT POPULATION COUNCIL 36MG/IMPLANT NORPLANT II POPULATION COUNCIL 75MG/IMPLANT NORPLANT SYSTEM IN PLASTIC CONTAINER WYETH PHARMS INC 36MG/IMPLANT TABLET; ORAL PLAN B TEVA WOMENS 0.75MG

N020627 N019897 N020544 N020088

001 001 001 001

Aug 15, 1996 Dec 10, 1990 Nov 01, 1996 Dec 10, 1990

N021045

001

Jul 28, 1999

LEVOPROPOXYPHENE NAPSYLATE ANHYDROUS

CAPSULE; ORAL NOVRAD LILLY SUSPENSION; ORAL NOVRAD LILLY

EQ 50MG BASE EQ 100MG BASE

N012928 N012928

006 004

EQ 50MG BASE/5ML

N012928

002

LEVORPHANOL TARTRATE
INJECTABLE; INJECTION LEVO-DROMORAN VALEANT PHARM INTL TABLET; ORAL LEVO-DROMORAN VALEANT PHARM INTL

2MG/ML

N008719

001

Dec 19, 1991

2MG

N008720

001

Dec 19, 1991

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

LEVOTHYROXINE SODIUM**
TABLET; ORAL LEVOLET VINTAGE

6 - 204 (of 346)

0.025MG 0.05MG 0.075MG 0.088MG 0.1MG 0.112MG 0.125MG 0.137MG 0.15MG 0.175MG 0.2MG 0.3MG --> 0.3MG

N021137 N021137 N021137 N021137 N021137 N021137 N021137 N021137 N021137 N021137 N021137 N021137 N021301 N021292 N021292 N021292 N021292 N021292 N021292 N021292 N021292 N021292 N021292 N021292 N021292

001 002 003 004 005 006 007 008 009 010 011 012 012 001 002 003 004 005 006 007 008 009 010 011 012

Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun

06, 06, 06, 06, 06, 06, 06, 06, 06, 06, 06, 06,

2003 2003 2003 2003 2003 2003 2003 2003 2003 2003 2003 2003

-->

LEVOXYL KING PHARMS NOVOTHYROX MERCK KGAA

May 25, 2001 May May May May May May May May May May May May 31, 31, 31, 31, 31, 31, 31, 31, 31, 31, 31, 31, 2002 2002 2002 2002 2002 2002 2002 2002 2002 2002 2002 2002

0.025MG 0.05MG 0.075MG 0.088MG 0.1MG 0.112MG 0.125MG 0.137MG 0.15MG 0.175MG 0.2MG 0.3MG

LIDOCAINE
AEROSOL; ORAL XYLOCAINE ASTRAZENECA 10% FILM, EXTENDED RELEASE; BUCCAL DENTIPATCH NOVEN 23MG/PATCH OINTMENT; TOPICAL ALPHACAINE CARLISLE 5% 5% 5% LIDOCAINE GRAHAM CHEM 5% XYLOCAINE ASTRAZENECA 5% PATCH; TOPICAL DENTIPATCH NOVEN 46.1MG/PATCH SOLUTION; TOPICAL XYLOCAINE ASTRAZENECA 5% SUPPOSITORY; RECTAL XYLOCAINE ASTRAZENECA 100MG

N014394

001

N020575

001

May 21, 1996

A084944 A084946 A084947 A080210 N008048

001 001 001 001 001

N020575

002

May 21, 1996

N014127

001

N013077

001

LIDOCAINE HYDROCHLORIDE
INJECTABLE; INJECTION ALPHACAINE HYDROCHLORIDE CARLISLE 2% LIDOCAINE HYDROCHLORIDE ABBOTT 10% 20%

A084721 A087980 A089362

001 001 001 Feb 02, 1983 May 25, 1988

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

LIDOCAINE HYDROCHLORIDE
INJECTABLE; INJECTION LIDOCAINE HYDROCHLORIDE ABRAXIS PHARM 1% A080420 1% A086761 1.5% A080420 2% A080420 2% A080420 2% A086761 2% N017508 4% N017508 20% N017508 AKORN 1% A085037 2% A085037 BAXTER HLTHCARE 1% A080407 2% A080407 BEL MAR 1% A080710 2% A080760 DELL LABS 1% A083387 2% A083388 ELKINS SINN 0.5% A085131 4% A084626 GD SEARLE LLC 1% A083135 2% A083135 GRAHAM CHEM 2% A080504 HOSPIRA 1% A040013 1.5% A088330 2% A088331 INTL MEDICATION 1% A083173 1% N017701 2% A083173 2% N017701 1GM/VIAL N018543 2GM/VIAL N018543 LYPHOMED 1% A080390 2% A080390 MILES 1% A080414 2% A080414 WATSON LABS 1% A080377 1% A083627 2% A080377 2% A083627 WYETH AYERST 1% A083083 2% A083083 LIDOCAINE HYDROCHLORIDE 0.1% AND DEXTROSE 5% IN PLASTIC CONTAINER BAXTER HLTHCARE 100MG/100ML N018461 LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER B BRAUN 200MG/100ML N018967 LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% HOSPIRA 200MG/100ML A083158 LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% IN PLASTIC CONTAINER ABBOTT 200MG/100ML N018954 HOSPIRA 200MG/100ML N018388 LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER B BRAUN 400MG/100ML N018967 LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% HOSPIRA 400MG/100ML A083158 LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER B BRAUN 800MG/100ML N018967 LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER HOSPIRA 1.5% A088326 10% A088367 20% A088368

6 - 205 (of 346)

001 001 005 002 004 002 001 002 004 001 002 001 002 001 001 001 001 001 001 001 002 001 001 001 001 001 002 002 001 001 002 001 002 001 002 001 001 002 002 001 002 001 001 005 001 001 002 006 003 001 001 001

Jun 23, 1995 May 17, 1984 May 17, 1984

Mar 30, 1984

Jul 09, 1985

Mar 30, 1984

Mar 30, 1984 Jul 31, 1984 Jul 31, 1984 Jul 31, 1984

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

LIDOCAINE HYDROCHLORIDE
INJECTABLE; INJECTION LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE BAXTER HLTHCARE 1% 2% INTL MEDICATION 4% LIDOCATON PHARMATON 2% XYLOCAINE ASTRAZENECA 1% 1.5% 2% INJECTABLE; SPINAL XYLOCAINE 1.5% W/ DEXTROSE 7.5% APP PHARMS 1.5% XYLOCAINE 5% W/ GLUCOSE 7.5% ASTRAZENECA 5% SOLUTION; ORAL LIDOCAINE HYDROCHLORIDE VISCOUS ACTAVIS MID ATLANTIC 2% INTL MEDICATION 2% SOLUTION; TOPICAL LARYNGOTRACHEAL ANESTHESIA KIT KENDALL IL 4% LIDOCAINE HYDROCHLORIDE PACO 4% LTA II KIT HOSPIRA 4% PEDIATRIC LTA KIT ABBOTT 2% HOSPIRA 2% SYSTEM; INTRADERMAL ZINGO POWDER PHARMS 0.5MG

6 - 206 (of 346)

A084625 A084625 N017702 A084727 N010418 N010418 N010418

001 002 002 001 005 009 007 Aug 17, 1983

N016297 N010496

001 002 Jul 07, 1982

A086578 A086389

001 001

Feb 02, 1982

A087931 A089688 A088542 A088572 A085995

001 001 001 001 001

Jun 10, 1983 Jun 30, 1989 Jul 31, 1984 Jul 31, 1984

N022114

001

Aug 16, 2007

LIDOCAINE HYDROCHLORIDE; OXYTETRACYCLINE

INJECTABLE; INJECTION TERRAMYCIN PFIZER

2%;50MG/ML 2%;125MG/ML

A060567 A060567

001 002

LIDOCAINE; PRILOCAINE
DISC; TOPICAL EMLA ASTRAZENECA

2.5%;2.5%

N020962

001

Feb 04, 1998

LINCOMYCIN HYDROCHLORIDE
CAPSULE; ORAL LINCOCIN PHARMACIA AND UPJOHN

EQ 250MG BASE EQ 500MG BASE

N050316 N050316

001 002

INJECTABLE; INJECTION LINCOMYCIN HYDROCHLORIDE WATSON LABS EQ 300MG BASE/ML

A063180

001

Apr 16, 1991

LINDANE
CREAM; TOPICAL KWELL REED AND CARNRICK LOTION; TOPICAL GAMENE SOLA BARNES HIND

1% 1%

A084218 N006309

001 001

1%

A084989

001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

LINDANE
LOTION; TOPICAL KWELL REED AND CARNRICK SCABENE STIEFEL SHAMPOO; TOPICAL GAMENE SOLA BARNES HIND KWELL REED AND CARNRICK SCABENE STIEFEL

6 - 207 (of 346)

1% 1% 1%

A084218 N006309 A086769

002 003 001

1% 1% 1% 1%

A084988 A084219 N010718 A087940

001 001 001 001 Apr 08, 1983

LINEZOLID
TABLET; ORAL ZYVOX PHARMACIA AND UPJOHN

400MG

N021130

001

Apr 18, 2000

LIOTHYRONINE SODIUM
TABLET; ORAL LIOTHYRONINE SODIUM WATSON LABS

EQ 0.025MG BASE EQ 0.05MG BASE

A085755 A085753

001 001

Jan 25, 1982 Feb 03, 1982

LIOTRIX (T4;T3)
TABLET; ORAL EUTHROID-0.5 PARKE DAVIS EUTHROID-1 PARKE DAVIS EUTHROID-2 PARKE DAVIS EUTHROID-3 PARKE DAVIS THYROLAR-5 FOREST LABS

0.03MG;0.0075MG 0.06MG;0.015MG 0.12MG;0.03MG 0.18MG;0.045MG 0.25MG;0.0625MG

N016680 N016680 N016680 N016680 N016807

001 002 003 004 006

LISINOPRIL
TABLET; ORAL LISINOPRIL TEVA

2.5MG 5MG 10MG 20MG 30MG 40MG 2.5MG

A075783 A075783 A075783 A075783 A075783 A075783 N019558

001 002 003 004 005 006 006

Jul Jul Jul Jul Jul Jul

01, 01, 01, 01, 01, 01,

2002 2002 2002 2002 2002 2002

PRINIVIL MERCK

Jan 28, 1994

LITHIUM CARBONATE
CAPSULE; ORAL ESKALITH NOVEN THERAP LITHIUM CARBONATE ABLE

300MG 150MG 300MG 300MG 600MG 300MG 300MG

N016860 A076823 A076121 A076823 A076823 A072542 A070407

001 001 001 002 003 001 001 Jun Sep Jun Jun Feb Mar 29, 27, 29, 29, 01, 19, 2004 2001 2004 2004 1989 1987

USL PHARMA WATSON LABS

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

LITHIUM CARBONATE
CAPSULE; ORAL LITHONATE SOLVAY TABLET; ORAL ESKALITH JDS PHARMS LITHANE BAYER PHARMS LITHIUM CARBONATE PFIZER LITHOTABS SOLVAY TABLET, EXTENDED RELEASE; ESKALITH CR JDS PHARMS LITHIUM CARBONATE ABLE BARR

6 - 208 (of 346)

300MG

N016782

001

300MG 300MG 300MG 300MG ORAL 450MG 300MG 300MG 450MG

N017971 N018833 N016834 N016980

001 001 001 001 Jul 18, 1985

N018152 A076382 A076170 A076366

001 001 001 001

Mar 29, 1982 Apr 21, 2003 Jun 10, 2002 Aug 21, 2003

LITHIUM CITRATE
SYRUP; ORAL LITHONATE SOLVAY

EQ 300MG CARBONATE/5ML

N017672

001

LOMEFLOXACIN HYDROCHLORIDE
TABLET; ORAL MAXAQUIN PHARMACIA

EQ 400MG BASE

N020013

001

Feb 21, 1992

LOPERAMIDE HYDROCHLORIDE
CAPSULE; ORAL IMODIUM MCNEIL PED 2MG LOPERAMIDE HYDROCHLORIDE ROXANE 2MG SANDOZ 2MG TEVA 2MG SOLUTION; ORAL IMODIUM JANSSEN PHARMA 1MG/5ML LOPERAMIDE HYDROCHLORIDE ALPHARMA US PHARMS 1MG/5ML DURAMED PHARMS BARR 1MG/5ML TEVA 1MG/5ML WATSON LABS 1MG/5ML TABLET; ORAL LOPERAMIDE HYDROCHLORIDE ABLE 2MG PERRIGO 2MG

N017690 A073080 A072993 A073122

001 001 001 001 Nov 27, 1991 Aug 28, 1992 Aug 30, 1991

N019037 A073187 A074991 A073478 A073062

001 001 001 001 001

Jul 31, 1984 Sep Dec Jun May 15, 29, 23, 28, 1992 1997 1995 1993

A073528 A074194

001 001

Nov 30, 1993 Oct 30, 1992

LORACARBEF
CAPSULE; ORAL LORABID KING PHARMS FOR SUSPENSION; ORAL LORABID KING PHARMS

200MG 400MG

N050668 N050668

001 002

Dec 31, 1991 Apr 05, 1996

100MG/5ML 200MG/5ML

N050667 N050667

001 002

Dec 31, 1991 Dec 31, 1991

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

LORATADINE
SYRUP; ORAL CLARITIN HIVES RELIEF SCHERING PLOUGH TABLET; ORAL LORATADINE PERRIGO

6 - 209 (of 346)

1MG/ML

N020641

003

Nov 19, 2003

10MG

N021512

001

Jun 24, 2004

LORAZEPAM
INJECTABLE; INJECTION LORAZEPAM AKORN BAXTER HLTHCARE DAVA PHARMS INC HOSPIRA

MARSAM PHARMS LLC

2MG/ML 2MG/ML 4MG/ML 2MG/ML 4MG/ML 2MG/ML 4MG/ML 4MG/ML 1MG/0.5ML 2MG/ML 2MG/ML 4MG/ML 4MG/ML

A074974 A074496 A074496 A074793 A074793 A074280 A074280 A074300 A074551 A074535 A074551 A074535 A074551

001 001 002 001 002 001 002 003 003 001 001 002 002

Jul Sep Sep Mar Mar May May Mar Sep Sep Sep Sep Sep

23, 28, 28, 16, 16, 27, 27, 19, 12, 12, 12, 12, 12,

1998 1998 1998 2000 2000 1994 1994 1997 1996 1996 1996 1996 1996

SOLUTION; ORAL LORAZEPAM ROXANE TABLET; ORAL LORAZ QUANTUM PHARMICS

0.5MG/5ML

A074648

001

Mar 18, 1997

0.5MG 1MG 2MG 0.5MG 1MG 2MG 0.5MG 1MG 2MG 0.5MG 0.5MG 1MG 1MG 2MG 2MG 0.5MG 1MG 2MG 0.5MG 1MG 2MG 1MG 2MG 1MG 2MG 0.5MG 0.5MG 1MG 2MG 2MG

A070200 A070201 A070202 A070727 A070728 A070729 A071434 A071435 A071436 A070472 A072553 A070473 A072554 A070474 A072555 A070675 A070676 A070677 A071245 A071246 A071247 A070539 A070540 A071038 A071039 A071086 A071117 A071087 A071088 A071110

001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001

Aug 09, 1985 Aug 09, 1985 Aug 09, 1985 Mar Mar Mar Sep Sep Sep Dec Mar Dec Mar Dec Mar Dec Dec Dec Feb Feb Feb Dec Dec Jan Jan Mar Jul Mar Mar Jul 07, 07, 07, 01, 01, 01, 10, 29, 10, 29, 10, 29, 01, 01, 01, 09, 09, 09, 22, 22, 12, 12, 23, 24, 23, 23, 24, 1986 1986 1986 1987 1987 1987 1985 1991 1985 1991 1985 1991 1986 1986 1986 1987 1987 1987 1986 1986 1988 1988 1987 1986 1987 1987 1986

LORAZEPAM AM THERAP

HALSEY

MUTUAL PHARM

PAR PHARM

SUPERPHARM

USL PHARMA WARNER CHILCOTT WATSON LABS

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

LOTEPREDNOL ETABONATE
SUSPENSION/DROPS; OPHTHALMIC LOTEMAX PHARMOS 0.5%

6 - 210 (of 346)

N020841

001

Mar 09, 1998

LOVASTATIN
TABLET; ORAL MEVACOR MERCK 10MG TABLET, EXTENDED RELEASE; ORAL ALTOPREV ANDRX LABS LLC 10MG

N019643

002

Mar 28, 1991

N021316

001

Jun 26, 2002

LOXAPINE HYDROCHLORIDE
CONCENTRATE; ORAL

LOXITANE C

WATSON LABS INJECTABLE; INJECTION

LOXITANE IM

WATSON LABS

EQ 25MG BASE/ML

N017658

001

EQ 50MG BASE/ML

N018039

001

LOXAPINE SUCCINATE
CAPSULE; ORAL

LOXAPINE SUCCINATE

ACTAVIS TOTOWA

EQ EQ EQ EQ EQ EQ EQ EQ

5MG BASE 10MG BASE 25MG BASE 50MG BASE 5MG BASE 10MG BASE 25MG BASE 50MG BASE

A076868 A076868 A076868 A076868 N017525 N017525 N017525 N017525

001 002 003 004 001

002

003

004

Aug Aug Aug Aug

04, 04, 04, 04,

2005 2005 2005 2005

LOXITANE WATSON LABS

TABLET; ORAL

LOXITANE

WATSON LABS

EQ 10MG BASE EQ 25MG BASE EQ 50MG BASE

N017525 N017525 N017525

006

007

008

LYPRESSIN
SOLUTION; NASAL

DIAPID

NOVARTIS

0.185MG/ML

N016755

001

MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
INJECTABLE; INJECTION ISOLYTE S PH 7.4 IN PLASTIC CONTAINER B BRAUN 30MG/100ML;37MG/100ML;0.82MG/100ML;370M N019006 G/100ML;530MG/100ML;500MG/100ML;12MG/10 0ML

001

Apr 04, 1984

MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE
INJECTABLE; INJECTION ISOLYTE S IN PLASTIC CONTAINER B BRAUN 30MG/100ML;37MG/100ML;370MG/100ML;530MG N018252 /100ML;500MG/100ML SOLUTION; IRRIGATION PHYSIOSOL IN PLASTIC CONTAINER HOSPIRA INC 14MG/100ML;37MG/100ML;222MG/100ML;526MG N018406 /100ML;502MG/100ML PHYSIOSOL PH 7.4 IN PLASTIC CONTAINER HOSPIRA INC 30MG/100ML;37MG/100ML;222MG/100ML;526MG N018406 /100ML;502MG/100ML

001

001

002

Jul 08, 1982

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DISCONTINUED DRUG PRODUCT LIST

6 - 211 (of 346)

MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE
SOLUTION; IRRIGATION SYNOVALYTE IN PLASTIC CONTAINER BAXTER HLTHCARE 30MG/100ML;37MG/100ML;368MG/100ML;526MG N019326 /100ML;502MG/100ML

001

Jan 25, 1985

MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE

TABLET, CHEWABLE; ORAL ZEGERID SANTARUS

700MG;20MG;600MG 700MG;40MG;600MG

N021850 N021850

001 002

Mar 24, 2006 Mar 24, 2006

MANGAFODIPIR TRISODIUM
INJECTABLE; INJECTION TESLASCAN GE HEALTHCARE

37.9MG/ML

N020652

001

Nov 26, 1997

MANGANESE CHLORIDE TETRAHYDRATE

FOR SOLUTION; ORAL LUMENHANCE BRACCO

3.49MG/GM

N020686

001

Dec 19, 1997

MANGANESE SULFATE
INJECTABLE; INJECTION MANGANESE SULFATE ABRAXIS PHARM

EQ 0.1MG MANGANESE/ML

N019228

001

May 05, 1987

MANNITOL
INJECTABLE; INJECTION MANNITOL 10% HOSPIRA MILES MANNITOL 15% HOSPIRA MILES MANNITOL 20% HOSPIRA MILES MANNITOL 25% ABRAXIS PHARM ASTRAZENECA HOSPIRA MERCK WATSON LABS MANNITOL 5% HOSPIRA SOLUTION; IRRIGATION RESECTISOL B BRAUN

10GM/100ML 10GM/100ML 15GM/100ML 15GM/100ML 20GM/100ML 20GM/100ML 12.5GM/50ML 12.5GM/50ML 12.5GM/50ML 12.5GM/50ML 12.5GM/50ML 12.5GM/50ML 5GM/100ML

N016269 N016472 N016269 N016472 N016269 N016472 A086754 A089239 A089240 N016269 N005620 A087460 N016269

002 002 003 005 004 004 001 001 001 005 001 001 001

May 06, 1987 May 06, 1987

Jun 27, 1983

5GM/100ML

N016704

002

MANNITOL; SORBITOL
SOLUTION; IRRIGATION

SORBITOL-MANNITOL

HOSPIRA 540MG/100ML;2.7GM/100ML SORBITOL-MANNITOL IN PLASTIC CONTAINER

HOSPIRA 540MG/100ML;2.7GM/100ML

A080224 N017636

001

001

MAPROTILINE HYDROCHLORIDE
TABLET; ORAL

LUDIOMIL

NOVARTIS

25MG

N017543

001

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DISCONTINUED DRUG PRODUCT LIST

MAPROTILINE HYDROCHLORIDE
TABLET; ORAL LUDIOMIL NOVARTIS

6 - 212 (of 346)

50MG 75MG MAPROTILINE HYDROCHLORIDE AM THERAP 25MG 50MG 75MG WATSON LABS 25MG 25MG 50MG 50MG 75MG 75MG

N017543 N017543 A072129 A072130 A072131 A071943 A072162 A071944 A072163 A071945 A072164

002 003 001 001 001 001 001 001 001 001 001

Sep 30, 1982 Jan Jan Jan Dec Jun Dec Jun Dec Jun 14, 14, 14, 30, 01, 30, 01, 30, 01, 1988 1988 1988 1987 1988 1987 1988 1987 1988

MASOPROCOL
CREAM; TOPICAL ACTINEX UNIV AZ CANCER CTR

10%

N019940

001

Sep 04, 1992

MAZINDOL
TABLET; ORAL MAZANOR WYETH AYERST SANOREX NOVARTIS

1MG 2MG 1MG 2MG

N017980 N017980 N017247 N017247

002 001 001 002

MEBENDAZOLE
TABLET, CHEWABLE; ORAL VERMOX JANSSEN PHARMS

100MG

N017481

001

MEBUTAMATE
TABLET; ORAL DORMATE MEDPOINTE PHARM HLC

600MG

N017374

001

MECAMYLAMINE HYDROCHLORIDE
TABLET; ORAL INVERSINE TARGACEPT

2.5MG

N010251

001

MECASERMIN RINFABATE RECOMBINANT

INJECTABLE; SUBCUTANEOUS IPLEX INSMED

36MG/0.6ML

N021884

001

Dec 12, 2005

MECLIZINE HYDROCHLORIDE
TABLET; ORAL MECLIZINE HYDROCHLORIDE ABC HOLDING 12.5MG 25MG ANABOLIC 25MG BUNDY 12.5MG 25MG IVAX SUB TEVA PHARMS 12.5MG 12.5MG 25MG KV PHARM 12.5MG 25MG

A085253 A085252 A085891 A084382 A084872 A083784 A084975 A084657 A085524 A085523

001 001 001 001 001 001 001 001 001 001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

MECLIZINE HYDROCHLORIDE
TABLET; ORAL MECLIZINE HYDROCHLORIDE PLIVA 12.5MG 25MG SUPERPHARM 12.5MG 25MG UDL 12.5MG 25MG VANGARD 12.5MG 25MG WATSON LABS 12.5MG 12.5MG TABLET, CHEWABLE; ORAL ANTIVERT PFIZER 25MG MECLIZINE HYDROCHLORIDE IVAX SUB TEVA PHARMS 25MG NEXGEN PHARMA INC 25MG PLIVA 25MG

6 - 213 (of 346)

A088732 A088734 A089113 A089114 A088256 A088257 A087877 A087620 A085195 A085269

001 001 001 001 001 001 001 001 001 001

Dec Dec Aug Aug Jun Jun Apr Jan

11, 11, 20, 20, 13, 13, 20, 04,

1985 1985 1985 1985 1983 1983 1982 1982

N010721 A084976 A086392 A088733

005 001 001 001

Dec 11, 1985

MECLOCYCLINE SULFOSALICYLATE
CREAM; TOPICAL MECLAN JOHNSON AND JOHNSON

1%

N050518

001

MECLOFENAMATE SODIUM
CAPSULE; ORAL MECLODIUM QUANTUM PHARMICS MECLOFENAMATE SODIUM AM THERAP BARR PAR PHARM SANDOZ USL PHARMA VITARINE WATSON LABS

EQ 50MG BASE EQ 100MG BASE EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ 50MG BASE 100MG BASE 50MG BASE 100MG BASE 50MG BASE 100MG BASE 50MG BASE 100MG BASE 50MG BASE 100MG BASE 50MG BASE 100MG BASE 50MG BASE 50MG BASE 100MG BASE 100MG BASE

A071380 A071381 A071362 A071363 A072848 A072809 A072077 A072078 A072262 A072263 A071007 A071008 A071710 A071684 A070400 A071640 A070401 A071641 N018006 N018006

001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 002

Jul 14, 1987 Jul 14, 1987 Feb Feb Mar Mar Mar Mar Nov Nov Mar Mar Jun Jun Nov Aug Nov Aug 10, 10, 20, 20, 10, 10, 29, 29, 25, 25, 15, 15, 25, 11, 25, 11, 1987 1987 1989 1989 1988 1988 1988 1988 1988 1988 1988 1988 1986 1987 1986 1987

MECLOMEN PARKE DAVIS

EQ 50MG BASE EQ 100MG BASE

MEDROXYPROGESTERONE ACETATE
INJECTABLE; INJECTION DEPO-PROVERA PHARMACIA AND UPJOHN TABLET; ORAL AMEN AMARIN PHARMS CURRETAB SOLVAY CYCRIN ESI

100MG/ML

N012541

002

10MG 10MG 2.5MG

A083242 A085686 A081239

001 001 001 Oct 30, 1992

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

MEDROXYPROGESTERONE ACETATE
TABLET; ORAL CYCRIN ESI

6 - 214 (of 346)

5MG 10MG MEDROXYPROGESTERONE ACETATE DURAMED PHARMS BARR 2.5MG 5MG 10MG

A081240 A089386 A040311 A040311 A040311

001 001 001 002 003

Oct 30, 1992 Sep 09, 1987 Dec 01, 1999 Dec 01, 1999 Dec 01, 1999

MEDRYSONE
SUSPENSION; OPHTHALMIC HMS ALLERGAN

1%

N016624

003

MEFLOQUINE HYDROCHLORIDE
TABLET; ORAL LARIAM ROCHE 250MG MEFLOQUINE HYDROCHLORIDE US ARMY WALTER REED 250MG

N019591 N019578

001 001

May 02, 1989 May 02, 1989

MEGESTROL ACETATE
TABLET; ORAL MEGACE BRISTOL MYERS SQUIBB MEGESTROL ACETATE TEVA USL PHARMA

20MG 40MG 40MG 20MG 40MG

N016979 N016979 A074745 A070646 A070647

001 002 001 001 001 Feb 27, 1998 Oct 02, 1987 Oct 02, 1987

MELOXICAM
TABLET; ORAL MELOXICAM MUTUAL PHARM ROXANE YABAO BIOPHARMS

7.5MG 15MG 7.5MG 15MG 7.5MG 15MG

A077935 A077935 A077925 A077925 A077933 A077933

001 002 001 002 001 002

Jul Jul Jul Jul Jul Jul

19, 19, 19, 19, 19, 19,

2006 2006 2006 2006 2006 2006

MEMANTINE HYDROCHLORIDE
TABLET; ORAL MEMANTINE SUN PHARMA GLOBAL

5MG 10MG

A090058 A090058 A090048 A090048 A090052 A090052

001 002 001 002 001 002

May 05, 2010 May 05, 2010 Apr Apr Oct Oct 14, 14, 25, 25, 2010 2010 2011 2011

MEMANTINE HYDROCHLORIDE DR REDDYS LABS LTD 5MG 10MG TEVA PHARMS 5MG 10MG

MENADIOL SODIUM DIPHOSPHATE

INJECTABLE; INJECTION KAPPADIONE LILLY SYNKAYVITE ROCHE

10MG/ML 5MG/ML 10MG/ML 37.5MG/ML

N005725 N003718 N003718 N003718

001 004 006 008

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DISCONTINUED DRUG PRODUCT LIST

MENADIOL SODIUM DIPHOSPHATE
TABLET; ORAL SYNKAYVITE ROCHE

6 - 215 (of 346)

5MG

N003718

010

MENADIONE
TABLET; ORAL MENADIONE LILLY

5MG

N002139

003

MENOTROPINS (FSH;LH)
INJECTABLE; INJECTION HUMEGON ORGANON USA INC MENOTROPINS FERRING PERGONAL SERONO REPRONEX FERRING

75 IU/VIAL;75 IU/VIAL 150 IU/VIAL;150 IU/VIAL 75 IU/VIAL;75 IU/VIAL 150 IU/VIAL;150 IU/VIAL 75 IU/AMP;75 IU/AMP 150 IU/AMP;150 IU/AMP 150 IU/VIAL;150 IU/VIAL

N020328 N020328 A073598 A073599 N017646 N017646 N021047

001 002 001 001 001 002 002

Sep 01, 1994 Sep 01, 1994 Jan 30, 1997 Jan 30, 1997

May 20, 1985 Aug 27, 1999

MEPENZOLATE BROMIDE
SOLUTION; ORAL CANTIL SANOFI AVENTIS US

25MG/5ML

N010679

004

MEPERIDINE HYDROCHLORIDE
INJECTABLE; INJECTION DEMEROL SANOFI AVENTIS US

25MG/ML 50MG/ML 75MG/ML 100MG/ML

N005010 N005010 N005010 N005010 A080388 A080385 A080387 A080389 A080386 A089781 A089782 A089783 A089784 A089785 A089786 A089787 A089788 A088279 A088280 A088281 A088282 A086332 A080364 A080364 A080364 A040305 A040163

007 002 009 003 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 002 003 001 001 001

MEPERIDINE HYDROCHLORIDE ABBOTT 25MG/ML 50MG/ML 50MG/ML 75MG/ML 100MG/ML ASTRAZENECA 25MG/ML 50MG/ML 50MG/ML 50MG/ML 75MG/ML 100MG/ML 100MG/ML 100MG/ML BAXTER HLTHCARE 25MG/ML 50MG/ML 75MG/ML 100MG/ML INTL MEDICATION 10MG/ML PARKE DAVIS 50MG/ML 75MG/ML 100MG/ML MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE HOSPIRA 10MG/ML MALLINCKRODT 10MG/ML

Mar Mar Mar Mar Mar Mar Mar Mar Jun Jun Jun Jun

31, 31, 31, 31, 31, 31, 31, 31, 15, 15, 15, 15,

1989 1989 1989 1989 1989 1989 1989 1989 1984 1984 1984 1984

Mar 10, 1999

May 12, 1997

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

MEPERIDINE HYDROCHLORIDE
SYRUP; ORAL DEMEROL SANOFI AVENTIS US 50MG/5ML TABLET; ORAL MEPERIDINE HYDROCHLORIDE DURAMED PHARMS BARR 50MG 100MG MUTUAL PHARM 50MG 100MG WYETH AYERST 50MG

6 - 216 (of 346)

N005010

005

A040318 A040318 A080448 A080448 A080454

001 002 001 002 001

Oct 05, 1999 Oct 05, 1999

MEPERIDINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE

INJECTABLE; INJECTION MEPERGAN BAXTER HLTHCARE CORP

25MG/ML;25MG/ML

N011730

001

MEPHENTERMINE SULFATE
INJECTABLE; INJECTION WYAMINE SULFATE BAXTER HLTHCARE CORP

EQ 15MG BASE/ML EQ 30MG BASE/ML

N008248 N008248

002 001

MEPHENYTOIN
TABLET; ORAL MESANTOIN NOVARTIS

100MG

N006008

001

MEPIVACAINE HYDROCHLORIDE
INJECTABLE; INJECTION ARESTOCAINE HYDROCHLORIDE SOLVAY 3% CARBOCAINE EASTMAN KODAK 3% MEPIVACAINE HYDROCHLORIDE GRAHAM CHEM 3% INTL MEDICATION 1%

A084777 N012125 A083559 A087509

002 003 001 001

Apr 18, 1982

Oct 05, 1982

MEPREDNISONE
TABLET; ORAL BETAPAR SCHERING

4MG

N016053

002

MEPROBAMATE
CAPSULE; ORAL EQUANIL WYETH AYERST 400MG CAPSULE, EXTENDED RELEASE; ORAL MEPROSPAN MEDPOINTE PHARM HLC 200MG 400MG TABLET; ORAL AMOSENE FERNDALE LABS 400MG BAMATE ALRA 200MG 400MG EQUANIL WYETH AYERST 200MG 400MG MEPRIAM TEVA 400MG

N012455

002

N011284 N011284

001 002

A084030 A080380 A080380 N010028 N010028 N016069

001 001 002 005 004 001

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DISCONTINUED DRUG PRODUCT LIST

MEPROBAMATE
TABLET; ORAL MEPROBAMATE BARR ELKINS SINN HEATHER IMPAX LABS IVAX SUB TEVA PHARMS

6 - 217 (of 346)

IVC INDS LANNETT LEDERLE LEE KM MALLARD MK LABS MUTUAL PHARM MYLAN NEXGEN PHARMA INC PARKE DAVIS PERRIGO PHARMAVITE PUREPAC PHARM PVT FORM ROXANE SANDOZ

SCHERER LABS SOLVAY STANLABS PHARM TABLICAPS USL PHARMA VALEANT PHARM INTL VANGARD WATSON LABS

WEST WARD WHITEWORTH TOWN PLSN MILTOWN MEDPOINTE PHARM HLC

600MG 200MG 400MG 400MG 600MG 200MG 400MG 200MG 400MG 600MG 400MG 200MG 400MG 400MG 400MG 400MG 200MG 400MG 200MG 400MG 400MG 200MG 400MG 200MG 400MG 200MG 400MG 400MG 200MG 400MG 400MG 600MG 200MG 400MG 400MG 400MG 200MG 200MG 400MG 400MG 200MG 400MG 200MG 400MG 400MG 200MG 400MG 600MG 600MG 200MG 400MG 200MG 400MG 200MG 400MG 600MG 200MG 400MG

A084230 N015426 N015426 N016928 A084329 N014322 N014322 N015438 N015438 A084181 A084153 N014882 N014882 A086299 A089538 N015072 N014368 N014368 A080699 A080699 A083618 A084220 A084589 A084744 A084744 A084546 A084547 A084438 A084804 A084804 N014601 A084332 N014547 A080655 N014547 A083343 A084435 N014474 N014474 A083494 A087825 A087826 N015139 N015139 A088011 A085720 A085721 A084274 A085719 N015417 N015417 A083830 A083442 N009698 N009698 A083919 N014359 N014359

001 002 001 003 001 002 001 001 002 001 001 002 001 001 001 002 004 002 001 002 001 001 001 001 002 001 001 001 001 002 001 001 002 001 001 001 001 002 004 001 001 001 006 005 001 001 001 001 001 003 002 001 001 004 002 001 002 001

Nov 25, 1987

Mar 18, 1982 Mar 18, 1982

Jul 14, 1982

NEURAMATE HALSEY

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DISCONTINUED DRUG PRODUCT LIST

MEPROBAMATE
TABLET; ORAL TRANMEP SOLVAY

6 - 218 (of 346)

400MG 400MG

A084369 N016249

001 001

MERSALYL SODIUM; THEOPHYLLINE

INJECTABLE; INJECTION MERSALYL-THEOPHYLLINE WATSON LABS

100MG/ML;50MG/ML

A084875

001

MESALAMINE
SUPPOSITORY; RECTAL CANASA AXCAN ROWASA ALAVEN PHARM

500MG 500MG

N021252 N019919

001 001

Jan 05, 2001 Dec 18, 1990

MESORIDAZINE BESYLATE
CONCENTRATE; ORAL SERENTIL NOVARTIS INJECTABLE; INJECTION SERENTIL NOVARTIS TABLET; ORAL SERENTIL NOVARTIS

EQ 25MG BASE/ML

N016997

001

EQ 25MG BASE/ML

N016775

001

EQ EQ EQ EQ

10MG BASE 25MG BASE 50MG BASE 100MG BASE

N016774 N016774 N016774 N016774

001 002 003 004

MESTRANOL; NORETHINDRONE
TABLET; ORAL-20 NORINYL WATSON LABS 0.1MG;2MG TABLET; ORAL-21 NORETHIN 1/50M-21 WATSON LABS 0.05MG;1MG NORETHINDRONE AND MESTRANOL WATSON LABS 0.05MG;1MG NORINYL 1+50 21-DAY WATSON LABS 0.05MG;1MG NORINYL 1+80 21-DAY GD SEARLE LLC 0.08MG;1MG ORTHO-NOVUM 1/50 21 ORTHO MCNEIL PHARM 0.05MG;1MG ORTHO-NOVUM 1/80 21 ORTHO MCNEIL PHARM 0.08MG;1MG ORTHO-NOVUM 10-21 ORTHO MCNEIL PHARM 0.06MG;10MG ORTHO-NOVUM 2-21 ORTHO MCNEIL PHARM 0.1MG;2MG TABLET; ORAL-28 NORETHIN 1/50M-28 WATSON LABS 0.05MG;1MG NORETHINDRONE AND MESTRANOL WATSON LABS 0.05MG;1MG NORINYL 1+80 28-DAY GD SEARLE LLC 0.08MG;1MG ORTHO-NOVUM 1/50 28 ORTHO MCNEIL JANSSEN 0.05MG;1MG ORTHO-NOVUM 1/80 28 ORTHO MCNEIL PHARM 0.08MG;1MG

N013625

004

A071539 A070758 N013625 N016724 N012728 N016715 N012728 N012728

001 001 002 001 004 001 001 005

Apr 12, 1988 Jul 01, 1988

A071540 A070759 N016725 N016709 N016715

001 001 001 001 002

Apr 12, 1988 Jul 01, 1988

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

MESTRANOL; NORETHYNODREL
TABLET; ORAL ENOVID GD SEARLE LLC TABLET; ORAL-20 ENOVID GD SEARLE LLC ENOVID-E GD SEARLE LLC TABLET; ORAL-21 ENOVID-E 21 GD SEARLE LLC

6 - 219 (of 346)

0.075MG;5MG 0.15MG;9.85MG

N010976 N010976

008 005

0.075MG;5MG 0.1MG;2.5MG

N010976 N010976

004 006

0.1MG;2.5MG

N010976

007

METAPROTERENOL SULFATE
AEROSOL, METERED; INHALATION ALUPENT BOEHRINGER INGELHEIM 0.65MG/INH SOLUTION; INHALATION ALUPENT BOEHRINGER INGELHEIM 0.4% 0.6% 5% METAPROTERENOL SULFATE ASTRAZENECA 0.4% 0.6% DEY 0.33% 0.5% 5% NEPHRON 0.4% 0.6% WOCKHARDT 5% PROMETA MURO 5% SYRUP; ORAL ALUPENT BOEHRINGER INGELHEIM 10MG/5ML METAPROTERENOL SULFATE MORTON GROVE 10MG/5ML TEVA 10MG/5ML TEVA PHARMS 10MG/5ML WOCKHARDT 10MG/5ML PROMETA MURO 10MG/5ML TABLET; ORAL ALUPENT BOEHRINGER INGELHEIM 10MG 20MG METAPROTERENOL SULFATE AM THERAP 10MG 20MG TEVA 10MG 20MG USL PHARMA 10MG 20MG

N016402

001

N018761 N018761 N017659 A071275 A071018 A071806 A071805 A070805 A071855 A071726 A072190 A073340

002 001 001 001 001 001 001 001 001 001 001 001

Oct 10, 1986 Jun 30, 1983

Jul Jul Aug Aug Aug Jul Jul Jun

27, 27, 05, 05, 17, 14, 14, 07,

1988 1988 1988 1988 1987 1988 1988 1988

Mar 30, 1992

N017571 A071656 A072761 A073034 A074702 A072023

001 001 001 001 001 001 Oct Feb Aug Mar 13, 27, 30, 24, 1987 1992 1991 1997

Sep 15, 1988

N015874 N015874 A072054 A072055 A072519 A072520 A071013 A071014

002 001 001 001 001 001 001 001 Jun Jun Mar Mar Jan Jan 23, 23, 30, 30, 25, 25, 1988 1988 1990 1990 1988 1988

METARAMINOL BITARTRATE
INJECTABLE; INJECTION ARAMINE MERCK METARAMINOL BITARTRATE ABRAXIS PHARM ELKINS SINN GD SEARLE LLC

EQ 10MG BASE/ML EQ 10MG BASE/ML EQ 10MG BASE/ML EQ 10MG BASE/ML

N009509 A080431 A083363 A086418

002 001 001 001

Dec 22, 1987

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

METARAMINOL BITARTRATE
INJECTABLE; INJECTION METARAMINOL BITARTRATE GD SEARLE LLC

6 - 220 (of 346)

EQ 20MG BASE/ML

A086418

002

METAXALONE
TABLET; ORAL SKELAXIN KING PHARMS

400MG

N013217

001

METFORMIN HYDROCHLORIDE
TABLET; ORAL GLUCOPHAGE BRISTOL MYERS SQUIBB

625MG 750MG

N020357 N020357 A075971 A075971 A075971 A078422 A078422 A078422 A075975 A075975 A075975 A075975 A075975 A076328 A076328 A076328

003 004 001 002 003 001 002 003 001 004 005 002 003 001 002 003

Nov 05, 1998 Nov 05, 1998 Jan Jan Jan Aug Aug Aug Jan Jan Jan Jan Jan Dec Dec Dec 25, 25, 25, 06, 06, 06, 24, 24, 24, 24, 24, 16, 16, 16, 2002 2002 2002 2007 2007 2007 2002 2002 2002 2002 2002 2002 2002 2002

METFORMIN HYDROCHLORIDE BARR 500MG 850MG 1GM IPCA LABS LTD 500MG 850MG 1GM IVAX SUB TEVA PHARMS 500MG 625MG 750MG 850MG 1GM TEVA 500MG 850MG 1GM TABLET, EXTENDED RELEASE; ORAL METFORMIN HYDROCHLORIDE ACTAVIS ELIZABETH 500MG 750MG BARR 500MG IVAX SUB TEVA PHARMS 500MG MUTUAL PHARM 500MG SANDOZ 500MG

A076450 A076878 A076496 A076545 A077124 A076223

001 001 001 001 001 001

Oct Apr Nov Dec Dec Dec

01, 13, 25, 01, 21, 14,

2004 2005 2005 2003 2005 2004

METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE

TABLET; ORAL AVANDAMET SB PHARMCO

500MG;EQ 1MG BASE

N021410

001

Oct 10, 2002

METHACYCLINE HYDROCHLORIDE
CAPSULE; ORAL RONDOMYCIN MEDPOINTE PHARM HLC SYRUP; ORAL RONDOMYCIN MEDPOINTE PHARM HLC

EQ 140MG BASE EQ 280MG BASE

A060641 A060641

001 002

EQ 70MG BASE/5ML

A060641

003

METHADONE HYDROCHLORIDE
SYRUP; ORAL DOLOPHINE HYDROCHLORIDE ROXANE 10MG/30ML TABLET; ORAL METHADONE HYDROCHLORIDE ROXANE 5MG 10MG 40MG SANDOZ 5MG

N006134

004

A088108 A088109 A074081 A040241

001 001 001 001

Mar Mar Apr May

08, 08, 28, 29,

1983 1983 1995 1998

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

METHADONE HYDROCHLORIDE
TABLET, DISPERSIBLE; ORAL WESTADONE SANDOZ 2.5MG TABLET, EFFERVESCENT; ORAL WESTADONE SANDOZ 5MG 10MG 40MG

6 - 221 (of 346)

N017108

001

N017108 N017108 N017108

002 003 004

METHAMPHETAMINE HYDROCHLORIDE
TABLET; ORAL METHAMPEX TEVA 10MG METHAMPHETAMINE HYDROCHLORIDE ABLE 5MG REXAR 5MG 10MG TEVA 5MG TABLET, EXTENDED RELEASE; ORAL DESOXYN LUNDBECK INC 5MG 10MG 15MG

A083889 A040529 A084931 A084931 A086359

001 001 001 002 001 Feb 25, 2004

N005378 N005378 N005378

004 003 005

METHANTHELINE BROMIDE
TABLET; ORAL BANTHINE SHIRE

50MG

N007390

001

METHARBITAL
TABLET; ORAL GEMONIL ABBOTT

100MG

N008322

001

METHAZOLAMIDE
TABLET; ORAL METHAZOLAMIDE APPLIED ANAL SANDOZ NEPTAZANE LEDERLE

25MG 50MG 25MG 50MG 25MG 50MG

A040011 A040011 A040102 A040102 N011721 N011721

001 002 001 002 002 001

Jul Jul Aug Aug

17, 17, 28, 28,

1997 1997 1996 1996

Nov 25, 1991

METHDILAZINE
TABLET, CHEWABLE; ORAL TACARYL WESTWOOD SQUIBB

3.6MG

N011950

009

METHDILAZINE HYDROCHLORIDE
SYRUP; ORAL METHDILAZINE HYDROCHLORIDE ALPHARMA US PHARMS 4MG/5ML TACARYL WESTWOOD SQUIBB 4MG/5ML TABLET; ORAL TACARYL WESTWOOD SQUIBB 8MG

A087122 N011950

001 007

N011950

006

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

METHICILLIN SODIUM
INJECTABLE; INJECTION STAPHCILLIN APOTHECON

6 - 222 (of 346)

EQ EQ EQ EQ EQ EQ

900MG 900MG 3.6GM 3.6GM 5.4GM 5.4GM

BASE/VIAL BASE/VIAL BASE/VIAL BASE/VIAL BASE/VIAL BASE/VIAL

A061449 N050117 A061449 N050117 A061449 N050117

001 001 002 002 003 003

METHIMAZOLE
TABLET; ORAL METHIMAZOLE CEDAR PHARMS MYLAN TAPAZOLE KING PHARMS

15MG 20MG 20MG 5MG 10MG

A040619 A040547 A040350 N007517 N007517

003 004 003 002 004

Jul 12, 2005 Feb 18, 2005 Jun 07, 2001

METHIXENE HYDROCHLORIDE
TABLET; ORAL TREST NOVARTIS

1MG

N013420

001

METHOCARBAMOL
INJECTABLE; INJECTION METHOCARBAMOL MARSAM PHARMS LLC TABLET; ORAL DELAXIN FERNDALE LABS FORBAXIN FOREST LABS METHOCARBAMOL ABLE AM THERAP ASCOT CLONMEL HLTHCARE HEATHER IMPAX LABS INWOOD LABS IVAX SUB TEVA PHARMS KV PHARM MUTUAL PHARM MYLAN NYLOS PIONEER PHARMS PURACAP PHARM PUREPAC PHARM

100MG/ML

A089849

001

Dec 27, 1991

500MG 750MG 500MG 750MG 500MG 750MG 500MG 750MG 500MG 750MG 500MG 750MG 500MG 750MG 500MG 500MG 750MG 500MG 750MG 500MG 750MG 500MG 750MG 750MG 500MG 750MG 500MG 750MG 500MG 750MG

A085454 A085136 A040413 A040413 A089417 A089418 A087660 A087661 A085961 A085963 A084675 A084924 A084927 A084928 A085137 A084648 A084649 A085660 A085658 A084488 A084486 A084259 A084323 A085033 A088731 A089082 A084231 A084471 A085718 A085718

001 001 001 002 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 002 001 001 002 Mar Mar Feb Feb Oct Oct 17, 17, 11, 11, 27, 27, 2003 2003 1987 1987 1982 1982

Dec 13, 1985 Dec 13, 1985

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

METHOCARBAMOL
TABLET; ORAL METHOCARBAMOL ROXANE SANDOZ SOLCO HLTHCARE SOLVAY SUPERPHARM TABLICAPS UPSHER SMITH WATSON LABS

6 - 223 (of 346)

500MG 750MG 500MG 750MG 500MG 750MG 500MG 750MG 500MG 750MG 500MG 500MG 750MG 500MG 750MG

A088646 A088647 A087283 A087282 A086989 A086988 A084448 A084449 A087589 A087590 A084846 A087453 A087454 A083605 A083605

001 001 001 001 001 001 001 001 001 001 001 001 001 001 002

Feb 29, 1984 Feb 29, 1984

Jan 22, 1982 Jan 22, 1982

METHOHEXITAL SODIUM
INJECTABLE; INJECTION BREVITAL SODIUM JHP PHARMS

5GM/VIAL

N011559

003

METHOTREXATE SODIUM
INJECTABLE; INJECTION ABITREXATE ABIC

EQ EQ EQ EQ EQ EQ EQ EQ

25MG BASE/ML 50MG BASE/VIAL 100MG BASE/VIAL 250MG BASE/VIAL 25MG BASE/VIAL 50MG BASE/VIAL 100MG BASE/VIAL 250MG BASE/VIAL

A089161 A089354 A089355 A089356 A087695 A087695 A087695 A088954 A081242 A089180 N011719 A040265 A040266 N011719 N011719 N011719 A089323 A088935 A089263 A089322 A088936 A088937 N011719 N011719 N011719 N011719 N011719 A088648 A089158 N011719

001 001 001 001 001 002 003 001 001 001 007 001 001 014 013 011 001 001 001 001 001 001 004 001 005 003 006 001 001 009

Mar Jul Jul Jul Apr Apr Apr Oct

10, 17, 17, 17, 08, 08, 08, 24,

1987 1987 1987 1987 1983 1983 1983 1985

FOLEX PHARMACIA AND UPJOHN

FOLEX PFS PHARMACIA AND UPJOHN

EQ 25MG BASE/ML EQ 25MG BASE/ML

Aug 23, 1991 Jan 03, 1986 Mar 31, 1982 Feb Feb Apr Apr Apr Jun Oct Jun Jun Oct Oct 26, 26, 13, 13, 13, 13, 11, 13, 13, 11, 11, 1999 1999 2005 2005 2005 1986 1985 1986 1986 1985 1985

METHOTREXATE LPF HOSPIRA EQ 25MG BASE/ML METHOTREXATE PRESERVATIVE FREE APP PHARMS EQ 25MG BASE/ML EQ 1GM BASE/VIAL HOSPIRA EQ 20MG BASE/2ML (EQ 10MG BASE/ML) EQ 500MG BASE/20ML (EQ 25MG BASE/ML) EQ 2.5GM BASE/100ML (EQ 25MG BASE/ML) METHOTREXATE SODIUM ABRAXIS PHARM EQ 2.5MG BASE/ML EQ 20MG BASE/VIAL EQ 25MG BASE/ML EQ 25MG BASE/ML EQ 50MG BASE/VIAL EQ 100MG BASE/VIAL HOSPIRA EQ 2.5MG BASE/ML EQ 20MG BASE/VIAL EQ 25MG BASE/ML EQ 50MG BASE/VIAL EQ 100MG BASE/VIAL NORBROOK EQ 25MG BASE/ML PHARMACHEMIE USA EQ 25MG BASE/ML METHOTREXATE SODIUM PRESERVATIVE FREE HOSPIRA EQ 1GM BASE/VIAL

May 09, 1986 Jul 08, 1988 Apr 07, 1988

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

METHOTREXATE SODIUM
INJECTABLE; INJECTION MEXATE BRISTOL

6 - 224 (of 346)

EQ EQ EQ EQ

20MG BASE/VIAL 50MG BASE/VIAL 100MG BASE/VIAL 250MG BASE/VIAL

A086358 A086358 A086358 A086358 A088760 A089887

001 002 003 004 001 001 Feb 14, 1985 Apr 14, 1989

MEXATE-AQ BRISTOL MYERS MEXATE-AQ PRESERVED BRISTOL MYERS SQUIBB TABLET; ORAL METHOTREXATE SODIUM DURAMED PHARMS BARR

EQ 25MG BASE/ML EQ 25MG BASE/ML

EQ 2.5MG BASE

A040233

001

Jun 17, 1999

METHOXAMINE HYDROCHLORIDE
INJECTABLE; INJECTION VASOXYL GLAXOSMITHKLINE

10MG/ML 20MG/ML

N006772 N006772

002 001

METHOXSALEN
CAPSULE; ORAL METHOXSALEN SANDOZ

10MG

A087781

001

Jun 08, 1982

METHSCOPOLAMINE BROMIDE
TABLET; ORAL METHSCOPOLAMINE BROMIDE PVT FORM 2.5MG

A080970

001

METHYCLOTHIAZIDE
TABLET; ORAL AQUATENSEN MEDPOINTE PHARM HLC METHYCLOTHIAZIDE IVAX PHARMS MYLAN PAR PHARM SANDOZ USL PHARMA WATSON LABS

5MG 2.5MG 5MG 2.5MG 2.5MG 5MG 2.5MG 5MG 5MG 2.5MG 2.5MG 5MG

N017364 A087913 A087786 A087671 A089135 A089136 A089835 A089837 A088745 A085487 A088750 A085476

001 001 001 001 001 001 001 001 001 001 001 001 Jun May Aug Feb Feb Aug Aug Mar Mar Sep Mar 03, 18, 17, 12, 12, 18, 18, 21, 11, 06, 11, 1982 1982 1982 1986 1986 1988 1988 1985 1982 1984 1982

METHYCLOTHIAZIDE; PARGYLINE HYDROCHLORIDE

TABLET; ORAL EUTRON ABBOTT

5MG;25MG

N016047

001

METHYCLOTHIAZIDE; RESERPINE
TABLET; ORAL DIUTENSEN-R MEDPOINTE PHARM HLC

2.5MG;0.1MG

N012708

005

METHYLDOPA
SUSPENSION; ORAL ALDOMET MERCK

250MG/5ML

N018389

001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

METHYLDOPA
TABLET; ORAL ALDOMET MERCK

6 - 225 (of 346)

125MG 250MG 500MG 125MG 250MG 500MG 125MG 250MG 500MG 125MG 250MG 500MG 125MG 250MG 500MG 125MG 250MG 500MG 125MG 250MG 500MG 125MG 250MG 500MG 125MG 250MG 500MG 125MG 250MG 500MG 250MG 500MG 125MG 250MG 500MG 125MG 125MG 250MG 250MG 250MG 500MG 500MG

N013400 N013400 N013400 A070070 A071006 A071009 A071751 A071752 A071753 A070073 A070060 A070074 A070535 A070536 A070537 A070331 A070332 A070333 A072126 A072127 A072128 A070749 A070750 A070452 A070192 A070193 A070194 A071700 N018934 N018934 A070669 A070670 A071105 A071106 A071067 A070245 A070260 A070246 A070261 A070703 A070247 A070262

003 001 002 003 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 002 001 001 001 001 001 001 001 001 001 001 001 001 Oct Dec Dec Mar Mar Mar Oct Oct Oct Jan Jan Jan Apr Apr Apr Jul Jul Jul Feb Feb Feb Apr Apr Apr Mar Jun Jun Jun Jun Dec Dec Dec Feb Jun Feb Jun Jun Feb Jun 15, 16, 16, 28, 28, 28, 09, 09, 09, 02, 02, 02, 15, 15, 15, 07, 07, 07, 07, 07, 07, 25, 25, 25, 02, 29, 29, 23, 23, 05, 05, 05, 25, 24, 25, 24, 06, 25, 24, 1985 1986 1986 1988 1988 1988 1986 1986 1986 1987 1987 1987 1986 1986 1986 1988 1988 1988 1986 1986 1986 1986 1986 1986 1988 1984 1984 1989 1989 1986 1986 1986 1986 1985 1986 1985 1986 1986 1985

METHYLDOPA ACCORD HLTH DURAMED PHARMS BARR HALSEY

MUTUAL PHARM

PAR PHARM

PARKE DAVIS

PLIVA

PUREPAC PHARM

ROXANE

SANDOZ

SUPERPHARM TEVA

WATSON LABS

METHYLDOPATE HYDROCHLORIDE
INJECTABLE; INJECTION ALDOMET MERCK 50MG/ML METHYLDOPATE HYDROCHLORIDE ABRAXIS PHARM 50MG/ML BAXTER HLTHCARE 50MG/ML HOSPIRA 50MG/ML 50MG/ML 50MG/ML 50MG/ML MARSAM PHARMS LLC 50MG/ML SMITH AND NEPHEW 50MG/ML

N013401 A070652 A070291 A070691 A070698 A070699 A070849 A071812 A070841

001 001 001 001 001 001 001 001 001 Jun Jul Jun Jun Jun Jun Dec Jan 03, 01, 19, 15, 15, 19, 22, 02, 1986 1986 1987 1987 1987 1987 1987 1987

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

METHYLPHENIDATE HYDROCHLORIDE
TABLET; ORAL METHYLPHENIDATE HYDROCHLORIDE ABLE 5MG 10MG 20MG ACTAVIS ELIZABETH 5MG 10MG 20MG TABLET, EXTENDED RELEASE; ORAL METHYLPHENIDATE HYDROCHLORIDE ABLE 20MG ACTAVIS ELIZABETH 20MG

6 - 226 (of 346)

A040404 A040404 A040404 A040321 A040321 A040321

001 002 003 001 002 003

Mar Mar Mar Feb Feb Feb

29, 29, 29, 05, 05, 05,

2001 2001 2001 2002 2002 2002

A076032 A075450

001 001

May 09, 2001 Dec 21, 2001

METHYLPREDNISOLONE
TABLET; ORAL MEDROL PHARMACIA AND UPJOHN METHYLPREDNISOLONE HEATHER PAR PHARM

2MG 24MG 4MG 16MG 24MG 32MG 4MG 4MG 16MG

N011153 N011153 A085650 A089207 A089208 A089209 A087341 A086161 A086159

002 005 001 001 001 001 001 001 001

Apr 25, 1988 Apr 25, 1988 Apr 25, 1988 Feb 09, 1982 Feb 09, 1982

SANDOZ WATSON LABS

METHYLPREDNISOLONE ACETATE
ENEMA; RECTAL MEDROL PHARMACIA AND UPJOHN 40MG/BOT INJECTABLE; INJECTION METHYLPREDNISOLONE ACETATE AKORN 40MG/ML 80MG/ML WATSON LABS 20MG/ML 20MG/ML 40MG/ML 40MG/ML 80MG/ML 80MG/ML M-PREDROL BEL MAR 40MG/ML 80MG/ML OINTMENT; TOPICAL MEDROL ACETATE PHARMACIA AND UPJOHN 0.25% 1%

N018102

001

A086903 A086903 A085597 A087248 A085374 A085600 A085595 A086507 A086666 A087135

001 002 001 001 001 001 001 001 001 001

Oct 20, 1982 Oct 20, 1982

N012421 N012421

001 002

METHYLPREDNISOLONE ACETATE; NEOMYCIN SULFATE

CREAM; TOPICAL NEO-MEDROL ACETATE PHARMACIA AND UPJOHN

0.25%;EQ 3.5MG BASE/GM 1%;EQ 3.5MG BASE/GM

A060611 A060611

002 001

METHYLPREDNISOLONE SODIUM SUCCINATE

INJECTABLE; INJECTION A-METHAPRED ABBOTT

EQ EQ EQ EQ

40MG BASE/VIAL 125MG BASE/VIAL 500MG BASE/VIAL 1GM BASE/VIAL

A089573 A089574 A089575 A089576

001 001 001 001

Feb Feb Feb Feb

22, 22, 22, 22,

1991 1991 1991 1991

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

METHYLPREDNISOLONE SODIUM SUCCINATE
INJECTABLE; INJECTION A-METHAPRED HOSPIRA

6 - 227 (of 346)

EQ EQ EQ EQ EQ EQ

40MG BASE/VIAL 125MG BASE/VIAL 500MG BASE/VIAL 500MG BASE/VIAL 1GM BASE/VIAL 1GM BASE/VIAL

A085853 A085855 A085854 A089173 A085852 A089174 A086906 A086906 A086906 A087535 A087535 A088676 A089143 A088677 A089144 A088678 A089186 A089187 A088679 A089188 A089189 A086906 A087812 A087813 A087851 A087852 A081267 A081268 A086953 A087030 A088523 A088524

001 001 001 001 001 001 002 003 004 001 002 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001

Aug 18, 1987 Aug 18, 1987

METHYLPREDNISOLONE ELKINS SINN

EQ 125MG BASE/VIAL EQ 500MG BASE/VIAL EQ 1GM BASE/VIAL ORGANON USA INC EQ 500MG BASE/VIAL EQ 1GM BASE/VIAL METHYLPREDNISOLONE SODIUM SUCCINATE ABRAXIS PHARM EQ 40MG BASE/VIAL EQ 40MG BASE/VIAL EQ 125MG BASE/VIAL EQ 125MG BASE/VIAL EQ 500MG BASE/VIAL EQ 500MG BASE/VIAL EQ 500MG BASE/VIAL EQ 1GM BASE/VIAL EQ 1GM BASE/VIAL EQ 1GM BASE/VIAL ELKINS SINN EQ 40MG BASE/VIAL INTL MEDICATION EQ 40MG BASE/VIAL EQ 125MG BASE/VIAL EQ 500MG BASE/VIAL EQ 1GM BASE/VIAL TEVA PARENTERAL EQ 500MG BASE/VIAL EQ 1GM BASE/VIAL WATSON LABS EQ 40MG BASE/VIAL EQ 125MG BASE/VIAL EQ 500MG BASE/VIAL EQ 1GM BASE/VIAL

Jun 25, 1982 Jun 25, 1982 Jun Mar Jun Mar Jun Mar Mar Jun Mar Mar Feb Feb Feb Feb Nov Nov Jul Jul Jul Jul 08, 28, 08, 28, 08, 28, 28, 08, 28, 28, 09, 09, 09, 09, 30, 30, 22, 22, 24, 24, 1984 1986 1984 1986 1984 1986 1986 1984 1986 1986 1983 1983 1983 1983 1992 1992 1982 1982 1984 1984

METHYLPREDNISOLONE; NEOMYCIN SULFATE

OINTMENT; OPHTHALMIC NEO-MEDROL PHARMACIA AND UPJOHN

0.1%;EQ 3.5MG BASE/GM

A060645

001

METHYLTESTOSTERONE
CAPSULE; ORAL METHYLTESTOSTERONE HEATHER VIRILON STAR PHARMS FL TABLET; BUCCAL ANDROID 5 VALEANT PHARM INTL ORETON SCHERING TABLET; BUCCAL/SUBLINGUAL METANDREN NOVARTIS METHYLTESTOSTERONE IMPAX LABS LILLY PUREPAC PHARM

10MG 10MG

A084967 A087750

001 001 Nov 24, 1982

5MG 10MG

A087222 A080281

001 001

5MG 10MG 10MG 10MG 10MG 10MG

N003240 N003240 A084287 A080256 A080308 A080475

004 005 001 001 001 001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

METHYLTESTOSTERONE
TABLET; BUCCAL/SUBLINGUAL METHYLTESTOSTERONE PVT FORM TABLICAPS USL PHARMA TABLET; ORAL METANDREN NOVARTIS METHYLTESTOSTERONE INWOOD LABS KV PHARM LANNETT LILLY PARKE DAVIS PUREPAC PHARM

6 - 228 (of 346)

5MG 10MG 10MG

A083836 A085125 A080271

001 001 001

10MG 25MG 10MG 25MG 10MG 10MG 25MG 25MG 10MG 25MG 10MG 10MG 25MG 25MG 5MG 10MG 25MG 10MG 25MG 10MG 25MG 10MG 25MG 25MG 10MG 25MG

N003240 N003240 A080839 A080973 A084312 A087092 A087111 A080256 A084244 A084241 A080309 A080475 A080310 A080475 A080214 A080214 A080214 A080313 A085270 A080933 A080931 A084331 A084331 A084642 N003158 N003158

001 003 001 001 001 001 001 002 001 001 001 002 001 003 001 002 003 001 001 001 001 001 002 001 001 002

Nov 05, 1982 Jan 27, 1983

PVT FORM

TABLICAPS WATSON LABS WEST WARD

ORETON METHYL SCHERING

METHYPRYLON
CAPSULE; ORAL NOLUDAR ROCHE ELIXIR; ORAL NOLUDAR ROCHE TABLET; ORAL NOLUDAR ROCHE

300MG

N009660

008

50MG/5ML

N009660

007

50MG 200MG

N009660 N009660

002 004

METHYSERGIDE MALEATE
TABLET; ORAL SANSERT NOVARTIS

2MG

N012516

001

METOCLOPRAMIDE HYDROCHLORIDE
CONCENTRATE; ORAL METOCLOPRAMIDE INTENSOL ROXANE EQ 10MG BASE/ML INJECTABLE; INJECTION METOCLOPRAMIDE HYDROCHLORIDE BEDFORD EQ 5MG BASE/ML EQ 5MG BASE/ML EQ 5MG BASE/ML HOSPIRA EQ 5MG BASE/ML

A072995

001

Jan 30, 1992

A072155 A072244 A072247 A070505

001 001 001 001

Mar Mar May Jun

30, 30, 18, 23,

1992 1992 1992 1989

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

METOCLOPRAMIDE HYDROCHLORIDE
INJECTABLE; INJECTION METOCLOPRAMIDE HYDROCHLORIDE HOSPIRA EQ 5MG BASE/ML EQ 5MG BASE/ML EQ 5MG BASE/ML EQ 5MG BASE/ML EQ 5MG BASE/ML EQ 5MG BASE/ML LYPHOMED EQ 10MG BASE/2ML NORBROOK EQ 10MG BASE/2ML SMITH AND NEPHEW EQ 5MG BASE/ML EQ 10MG BASE/2ML REGLAN BAXTER HLTHCARE CORP EQ 10MG BASE/ML SOLUTION; ORAL METOCLOPRAMIDE HYDROCHLORIDE ACTAVIS MID ATLANTIC EQ 5MG BASE/5ML MORTON GROVE EQ 5MG BASE/5ML PACO EQ 5MG BASE/5ML ROXANE EQ 5MG BASE/5ML TEVA EQ 5MG BASE/5ML EQ 5MG BASE/5ML REGLAN ROBINS AH EQ 5MG BASE/5ML TABLET; ORAL CLOPRA QUANTUM PHARMICS EQ 5MG BASE EQ 10MG BASE CLOPRA-"YELLOW" QUANTUM PHARMICS EQ 10MG BASE MAXOLON KING PHARMS EQ 10MG BASE METOCLOPRAMIDE HYDROCHLORIDE CLONMEL HLTHCARE EQ 10MG BASE HALSEY EQ 10MG BASE INTERPHARM EQ 10MG BASE MUTUAL PHARM EQ 10MG BASE EQ 10MG BASE PAR PHARM EQ 10MG BASE SANDOZ EQ 5MG BASE EQ 5MG BASE EQ 10MG BASE EQ 10MG BASE EQ 10MG BASE SCHERING EQ 10MG BASE SUPERPHARM EQ 10MG BASE USL PHARMA EQ 10MG BASE WATSON LABS EQ 10MG BASE EQ 10MG BASE EQ 10MG BASE EQ 10MG BASE TABLET, ORALLY DISINTEGRATING; ORAL REGLAN ODT MEDA PHARMS EQ 5MG BASE EQ 10MG BASE

6 - 229 (of 346)

A070506 A070847 A071291 A071990 A073117 A074147 A070293 A070892 A070623 A070622 N017862

001 001 001 001 001 001 001 001 001 001 004

Jun Nov Mar Jan Jan Aug Jan Aug Mar Mar

22, 07, 03, 18, 17, 02, 24, 26, 02, 02,

1989 1988 1989 1989 1991 1996 1986 1988 1987 1987

May 28, 1987

A071340 A070949 A071665 A072038 A070819 A071315 N018821

001 001 001 001 001 001 001

Aug Mar Dec Dec Jul Jun

18, 06, 05, 05, 10, 30,

1988 1987 1988 1988 1987 1993

Mar 25, 1983

A072384 A070294 A070632 A070106 A072639 A070906 A071213 A070660 A071536 A070342 A072436 A074478 A070850 A072215 A074478 A070598 A070926 A070339 A070363 A070453 A070511 A070645

001 001 001 001 001 001 001 001 001 001 001 001 001 001 002 001 001 001 001 001 001 001

Jun 02, 1988 Jul 29, 1985 Oct 28, 1985 Mar 04, 1986 May Oct Sep Feb Apr Mar Jun Oct Feb Jan Oct Feb Jun Jul Mar Jun Jan May 09, 28, 24, 10, 28, 25, 22, 05, 03, 30, 05, 02, 26, 29, 02, 06, 22, 11, 1991 1986 1986 1987 1993 1986 1989 1995 1987 1990 1995 1987 1987 1985 1987 1986 1986 1987

N021793 N021793

001 002

Jun 10, 2005 Jun 10, 2005

METOCURINE IODIDE
INJECTABLE; INJECTION METUBINE IODIDE LILLY

2MG/ML

N006632

003

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

METOLAZONE
TABLET; ORAL DIULO GD SEARLE LLC

6 - 230 (of 346)

2.5MG 5MG 10MG 10MG 10MG 0.5MG

N018535 N018535 N018535 A076482 A076891 N019532

001 002 003 002 001 001 Apr 29, 2004 Jul 21, 2004 Oct 30, 1987

METOLAZONE ROXANE WATSON LABS MYKROX UCB INC

METOPROLOL FUMARATE
TABLET, EXTENDED RELEASE; ORAL LOPRESSOR NOVARTIS EQ 100MG EQ 200MG EQ 300MG EQ 400MG

TARTRATE TARTRATE TARTRATE TARTRATE

N019786 N019786 N019786 N019786

001 002 003 004

Dec Dec Dec Dec

27, 27, 27, 27,

1989 1989 1989 1989

METOPROLOL TARTRATE
TABLET; ORAL METOPROLOL TARTRATE APOTHECON MYLAN PUREPAC PHARM SOLCO HLTHCARE TEVA TEVA PHARMS

50MG 100MG 50MG 100MG 50MG 100MG 50MG 100MG 50MG 100MG 50MG 100MG

A074258 A074258 A073666 A073666 A074380 A074380 A074453 A074453 A074143 A074143 A074333 A074333

001 002 001 002 001 002 001 002 001 002 001 002

Jan Jan Dec Dec Jul Jul Apr Apr Sep Sep Jan Jan

27, 27, 21, 21, 29, 29, 27, 27, 30, 30, 27, 27,

1994 1994 1993 1993 1994 1994 1995 1995 1994 1994 1994 1994

METRIZAMIDE
INJECTABLE; INJECTION AMIPAQUE GE HEALTHCARE

2.5GM/VIAL 3.75GM/VIAL 6.75GM/VIAL 13.5GM/VIAL

N017982 N017982 N017982 N017982

003 001 002 004

Sep 12, 1983

Sep 12, 1983

METRONIDAZOLE
CAPSULE; ORAL METRONIDAZOLE ABLE INJECTABLE; INJECTION METRO I.V. B BRAUN METRONIDAZOLE ABBOTT ABRAXIS PHARM ELKINS SINN INTL MEDICATION WATSON LABS TABLET; ORAL METROMIDOL LABS AF

375MG

A076505

001

Nov 13, 2003

500MG/100ML 500MG/100ML 500MG/100ML 500MG/100ML 500MG/100ML 500MG/100ML 500MG/100ML

N018674 N018889 A070071 N018907 A070004 A070042 A070170

001 001 001 001 001 001 001

Aug 31, 1982 Nov Dec Mar May Dec Apr 18, 03, 30, 08, 20, 01, 1983 1984 1984 1985 1984 1986

250MG 500MG

A074523 A074523

001 002

Oct 24, 1996 Oct 24, 1996

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

METRONIDAZOLE
TABLET; ORAL METRONIDAZOLE ABLE HALSEY IVAX SUB TEVA PHARMS LNK MUTUAL PHARM PAR PHARM SANDOZ

6 - 231 (of 346)

SUPERPHARM WATSON LABS WORLD GEN PROTOSTAT ORTHO MCNEIL PHARM SATRIC SAVAGE LABS

250MG 500MG 250MG 500MG 250MG 500MG 250MG 250MG 500MG 250MG 500MG 250MG 250MG 500MG 500MG 250MG 500MG 250MG 500MG 250MG 500MG 250MG 500MG

A076519 A076519 A070021 A070593 N018517 N018517 N019029 N018818 N018818 N018845 N018930 N018620 N018740 N018620 N018740 A070008 A070009 N018599 N018599 A070040 A070039 N018871 N018871 A070029 A070731

001 002 001 001 001 002 001 001 002 001 001 001 001 002 002 001 001 001 002 001 001 001 002 001 001

Jun Jun Apr Feb May Apr Feb Feb Aug Aug Mar Oct Jun Oct Dec Dec Sep Feb Jan Jan

27, 27, 02, 27, 05, 10, 16, 16, 18, 18, 04, 22, 02, 22, 11, 11, 17, 13, 29, 29,

2003 2003 1985 1986 1982 1984 1983 1983 1983 1983 1982 1982 1983 1982 1984 1984 1982 1984 1985 1985

Mar 02, 1983 Mar 02, 1983 Mar 19, 1985 Jun 08, 1987

250MG 500MG TABLET, EXTENDED RELEASE; ORAL METRONIDAZOLE ABLE 750MG

A076462

001

Jun 25, 2003

METRONIDAZOLE HYDROCHLORIDE
INJECTABLE; INJECTION FLAGYL I.V. PFIZER EQ 500MG BASE/VIAL METRONIDAZOLE HYDROCHLORIDE ABRAXIS PHARM EQ 500MG BASE/VIAL

N018353 A070295

001 001 Oct 15, 1985

METYRAPONE
TABLET; ORAL METOPIRONE NOVARTIS

250MG

N012911

001

MEXILETINE HYDROCHLORIDE
CAPSULE; ORAL MEXILETINE HYDROCHLORIDE SANDOZ 150MG 200MG 250MG MEXITIL BOEHRINGER INGELHEIM 150MG 200MG 250MG

A074450 A074450 A074450 N018873 N018873 N018873

001 002 003 002 003 004

May 16, 1996 May 16, 1996 May 16, 1996 Dec 30, 1985 Dec 30, 1985 Dec 30, 1985

MEZLOCILLIN SODIUM MONOHYDRATE

INJECTABLE; INJECTION MEZLIN BAYER PHARMS

EQ 1GM BASE/VIAL EQ 1GM BASE/VIAL EQ 1GM BASE/VIAL

A062333 A062372 N050549

001 005 001

Jan 13, 1983

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

MEZLOCILLIN SODIUM MONOHYDRATE
INJECTABLE; INJECTION

MEZLIN

BAYER PHARMS

6 - 232 (of 346)

EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ

2GM BASE/VIAL 2GM BASE/VIAL 2GM BASE/VIAL 3GM BASE/VIAL 3GM BASE/VIAL 3GM BASE/VIAL 3GM BASE/VIAL 4GM BASE/VIAL 4GM BASE/VIAL 4GM BASE/VIAL 4GM BASE/VIAL 20GM BASE/VIAL 20GM BASE/VIAL

A062333 A062372 N050549 A062333 A062372 A062697 N050549 A062333 A062372 A062697 N050549 A062372 N050549

002 001 002 003 002 001 003 004 003 002 004 004 005

May 13, 1982

May 13, 1982 Jan 22, 1987

May 13, 1982 Jan 22, 1987 Mar 02, 1988 Mar 02, 1988

MICONAZOLE
INJECTABLE; INJECTION MONISTAT JANSSEN PHARMA

10MG/ML

N018040

001

MICONAZOLE NITRATE
CREAM; TOPICAL MONISTAT-DERM INSIGHT PHARMS 2% CREAM; VAGINAL MICONAZOLE NITRATE TEVA 2% TEVA PHARMS 2% CREAM, SUPPOSITORY; TOPICAL, VAGINAL M-ZOLE 7 DUAL PACK ACTAVIS MID ATLANTIC 2%,100MG LOTION; TOPICAL MONISTAT-DERM INSIGHT PHARMS 2% TAMPON; VAGINAL MONISTAT 5 PERSONAL PRODS 100MG

N017494

001

A074136 A074030

001 001

Jan 04, 1995 Oct 30, 1992

A074586

001

Jul 17, 1997

N017739

001

N018592

001

Oct 27, 1989

MIDAZOLAM HYDROCHLORIDE
INJECTABLE; INJECTION MIDAZOLAM HYDROCHLORIDE APOTHECON EQ EQ EQ ASTRAZENECA EQ BEDFORD EQ BEN VENUE EQ HOSPIRA EQ EQ EQ HOSPIRA INC EQ EQ VERSED HLR EQ EQ SYRUP; ORAL VERSED ROCHE EQ

1MG 5MG 5MG 5MG 5MG 5MG 1MG 5MG 5MG 1MG 5MG

BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML

A075620 A075620 A075641 A075263 A075249 A075455 A075396 A075396 A075484 A075409 A075409 N018654 N018654

001 002 001 001 001 001 001 002 001 002 001 002 001

Nov Nov Oct Jun Jun Jun Jun Jun Jun Jun Jun

01, 01, 19, 26, 23, 20, 20, 20, 20, 20, 20,

2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000

1MG BASE/ML 5MG BASE/ML

May 26, 1987 Dec 20, 1985

2MG BASE/ML

N020942

001

Oct 15, 1998

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

MILRINONE LACTATE
INJECTABLE; INJECTION MILRINONE LACTATE BAXTER HLTHCARE CORP BIONICHE PHARMA HOSPIRA

6 - 233 (of 346)

EQ 1MG BASE/ML EQ 1MG BASE/ML EQ 1MG BASE/ML EQ 1MG BASE/ML MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER BAXTER HLTHCARE EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) PRIMACOR SANOFI AVENTIS US EQ 1MG BASE/ML PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER SANOFI AVENTIS US EQ 10MG BASE/100ML EQ 15MG BASE/100ML EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)

A075852 A076428 A075830 A075884 A075510 A076259 N019436 N020343 N020343 N020343 N020343

001 001 001 001 001 001 001 001 002 003 004

May Jun May May

28, 16, 28, 28,

2002 2003 2002 2002

May 28, 2002 Aug 08, 2002 Dec 31, 1987 Aug Aug Aug Aug 09, 09, 09, 09, 1994 1994 1994 1994

MINOCYCLINE HYDROCHLORIDE
CAPSULE; ORAL DYNACIN MEDICIS MINOCIN TRIAX PHARMS

EQ 50MG BASE EQ 50MG BASE EQ 100MG BASE EQ 75MG BASE

A063066 N050315 N050315 N050649

001 002 001 003

Aug 14, 1990

TRIAX PHARMS LLC INJECTABLE; INJECTION MINOCIN LEDERLE EQ 100MG BASE/VIAL SUSPENSION; ORAL MINOCIN TRIAX PHARMS EQ 50MG BASE/5ML TABLET; ORAL MINOCYCLINE HYDROCHLORIDE TRIAX PHARMS EQ 50MG BASE EQ 100MG BASE TABLET, EXTENDED RELEASE; ORAL MINOCYCLINE HYDROCHLORIDE LUPIN LTD EQ 55MG BASE

Feb 12, 2001

A062139

001

N050445

001

N050451 N050451

003 002

Aug 10, 1982 Aug 10, 1982

A091424

002

Nov 30, 2011

MINOXIDIL
SOLUTION; TOPICAL MINOXIDIL (FOR MEN) BAUSCH AND LOMB COPLEY PHARM SIGHT PHARMS TEVA MINOXIDIL (FOR WOMEN) SIGHT PHARMS TABLET; ORAL LONITEN PHARMACIA AND UPJOHN MINODYL QUANTUM PHARMICS MINOXIDIL ROYCE LABS USL PHARMA

2% 2% 2% 2% 2%

A074643 A074500 A074743 A074589 A074743

001 001 002 001 001

Apr May Oct Apr

09, 23, 18, 05,

1996 1996 1996 1996

Oct 18, 1996

2.5MG 10MG 2.5MG 10MG 2.5MG 10MG 2.5MG

N018154 N018154 A072153 A071534 A071799 A071796 A071537

001 003 001 001 001 001 001 Jul 13, 1988 Mar 19, 1987 Nov 10, 1987 Nov 10, 1987 Dec 16, 1988

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

MIRTAZAPINE
TABLET; ORAL MIRTAZAPINE ACTAVIS ELIZABETH

6 - 234 (of 346)

15MG 30MG 45MG ACTAVIS TOTOWA 15MG 30MG 45MG IVAX SUB TEVA PHARMS 15MG 30MG 45MG ROXANE 15MG 30MG 45MG SANDOZ 15MG 30MG 45MG TABLET, ORALLY DISINTEGRATING; ORAL MIRTAZAPINE ACTAVIS TOTOWA 15MG 30MG 45MG

A076308 A076308 A076308 A076241 A076241 A076241 A076244 A076244 A076244 A076270 A076270 A076270 A076189 A076189 A076189

001 002 003 001 002 003 001 002 003 001 002 003 001 002 003

Jun Jun Jun Jun Jun Jun Dec Dec Dec Jun Jun Jun Jun Jun Jun

20, 20, 20, 25, 25, 25, 22, 22, 22, 19, 19, 19, 19, 19, 19,

2003 2003 2003 2003 2003 2003 2003 2003 2003 2003 2003 2003 2003 2003 2003

A076689 A076689 A076689

001 002 003

Aug 31, 2005 Aug 31, 2005 Aug 31, 2005

MITOMYCIN
INJECTABLE; INJECTION MITOMYCIN HOSPIRA MITOZYTREX SUPERGEN MUTAMYCIN BRISTOL BRISTOL MYERS

20MG/VIAL 5MG/VIAL 5MG/VIAL 20MG/VIAL 5MG/VIAL 20MG/VIAL 40MG/VIAL

A064106 N050763 N050450 N050450 A062336 A062336 A062336

001 001 001 002 001 002 003

Nov 29, 1995 Nov 14, 2002

Mar 10, 1988

MITOXANTRONE HYDROCHLORIDE
INJECTABLE; INJECTION NOVANTRONE EMD SERONO

EQ 20MG BASE/10ML (EQ 2MG BASE/ML) EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) EQ 30MG BASE/15ML (EQ 2MG BASE/ML)

N019297 N019297 N019297

001 002 003

Dec 23, 1987 Dec 23, 1987 Dec 23, 1987

MIVACURIUM CHLORIDE
INJECTABLE; INJECTION MIVACRON ABBOTT EQ MIVACRON IN DEXTROSE 5% IN ABBOTT EQ EQ MIVACURIUM CHLORIDE PISGAH LABS EQ

2MG BASE/ML PLASTIC CONTAINER 0.5MG BASE/ML 50MG BASE/100ML 2MG BASE/ML

N020098 N020098 N020098 A078562

001 002 003 001

Jan 22, 1992 Jan 22, 1992 Jan 22, 1992 Apr 30, 2009

MOLINDONE HYDROCHLORIDE
CAPSULE; ORAL MOBAN ENDO PHARMS

5MG 10MG 25MG

N017111 N017111 N017111

001 002 003

CONCENTRATE; ORAL MOBAN ENDO PHARMS

20MG/ML

N017938

001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

MOLINDONE HYDROCHLORIDE
TABLET; ORAL MOBAN ENDO PHARMS

6 - 235 (of 346)

5MG 10MG 25MG 50MG 100MG

N017111 N017111 N017111 N017111 N017111

004 005 006 007 008

MONOBENZONE
CREAM; TOPICAL BENOQUIN VALEANT PHARM INTL

20%

N008173

003

MONOCTANOIN
LIQUID; PERFUSION, BILIARY MOCTANIN ETHITEK 100%

N019368

001

Oct 29, 1985

MORICIZINE HYDROCHLORIDE
TABLET; ORAL ETHMOZINE SHIRE

200MG 250MG 300MG

N019753 N019753 N019753

001 002 003

Jun 19, 1990 Jun 19, 1990 Jun 19, 1990

MORPHINE SULFATE
INJECTABLE; INJECTION MORPHINE SULFATE HOSPIRA MALLINCKRODT

0.5MG/ML 1MG/ML 2MG/ML INJECTABLE, LIPOSOMAL; EPIDURAL DEPODUR EKR THERAP 15MG/1.5ML (10MG/ML) 20MG/2ML (10MG/ML) TABLET, EXTENDED RELEASE; ORAL MORPHINE SULFATE WATSON LABS 100MG

N019917 N020631 N020631

001 001 002

Oct 30, 1992 Jul 03, 1996 Jul 03, 1996

N021671 N021671

002 003

May 18, 2004 May 18, 2004

A075656

001

Jan 30, 2001

MOXALACTAM DISODIUM
INJECTABLE; INJECTION MOXAM LILLY

EQ EQ EQ EQ EQ

250MG BASE/VIAL 500MG BASE/VIAL 1GM BASE/VIAL 2GM BASE/VIAL 10GM BASE/VIAL

N050550 N050550 N050550 N050550 N050550

001 002 003 004 008

MYCOPHENOLATE MOFETIL
TABLET; ORAL MYCOPHENOLATE MOFETIL DR REDDYS LABS LTD

500MG

A090464

001

Sep 13, 2010

NABUMETONE
TABLET; ORAL NABUMETONE ACTAVIS ELIZABETH COPLEY PHARM SANDOZ

500MG 750MG 750MG 500MG 750MG

A079093 A079093 A075179 A075590 A075590

001 002 001 001 002

Feb Feb Jun Feb Feb

27, 27, 06, 25, 25,

2009 2009 2000 2002 2002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

NABUMETONE
TABLET; ORAL RELAFEN SMITHKLINE BEECHAM

6 - 236 (of 346)

500MG 750MG

N019583 N019583

001 002

Dec 24, 1991 Dec 24, 1991

NADOLOL
TABLET; ORAL CORGARD KING PHARMS NADOLOL IVAX SUB TEVA PHARMS TEVA PHARMS

120MG 160MG 120MG 160MG 80MG 120MG 160MG

N018063 N018063 A074255 A074255 A074368 A074368 A074368

003 004 002 003 001 002 003 Jan Jan Aug Aug Aug 24, 24, 31, 31, 31, 1996 1996 1994 1994 1994

NAFCILLIN SODIUM
CAPSULE; ORAL UNIPEN WYETH AYERST FOR SOLUTION; ORAL UNIPEN WYETH AYERST INJECTABLE; INJECTION NAFCILLIN SODIUM APOTHECON

EQ 250MG BASE

N050111

001

EQ 250MG BASE/5ML

N050199

001

MARSAM PHARMS LLC

SANDOZ NALLPEN GLAXOSMITHKLINE

EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ

500MG BASE/VIAL 1GM BASE/VIAL 2GM BASE/VIAL 4GM BASE/VIAL 500MG BASE/VIAL 1GM BASE/VIAL 1.5GM BASE/VIAL 2GM BASE/VIAL 4GM BASE/VIAL 10GM BASE/VIAL 500MG BASE/VIAL 500MG BASE/VIAL 1GM BASE/VIAL 1GM BASE/VIAL 2GM BASE/VIAL 2GM BASE/VIAL 10GM BASE/VIAL

A061984 A061984 A061984 A061984 A062844 A062844 A062844 A062844 A062844 A063008 A062527 A061999 A061999 A062755 A061999 A062755 A061999 A062717 N050320 A062717 A062717 N050320 N050320 N050320 N050320 N050320

001 002 003 005 001 002 003 004 005 001 001 001 002 001 003 002 004 001 001 002 004 003 004 005 006 002

Oct Oct Oct Oct Oct Sep Aug

26, 26, 26, 26, 26, 29, 02,

1988 1988 1988 1988 1988 1988 1984

Dec 19, 1986 Dec 19, 1986

EQ 500MG BASE/VIAL EQ 500MG BASE/VIAL EQ 1GM BASE/VIAL EQ 2GM BASE/VIAL EQ 2GM BASE/VIAL EQ 4GM BASE/VIAL EQ 10GM BASE/VIAL EQ 20GM BASE/VIAL UNIPEN IN PLASTIC CONTAINER WYETH AYERST EQ 1GM BASE/VIAL TABLET; ORAL UNIPEN WYETH AYERST EQ 500MG BASE

UNIPEN WYETH AYERST

Dec 16, 1986 Dec 16, 1986 Dec 16, 1986

N050462

001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

NALBUPHINE HYDROCHLORIDE
INJECTABLE; INJECTION NALBUPHINE ABRAXIS PHARM

6 - 237 (of 346)

10MG/ML 20MG/ML

A070751 A070752 N020200 A070917 A072070 A072071 A072072 A072073 A072074 A072075 A074471 A074471 N018024 N018024

001 001 001 001 001 001 001 001 001 001 001 002 001 002

Jul 02, 1986 Sep 24, 1986 Mar Feb Apr Apr Apr Apr Apr Apr Mar Mar 12, 03, 10, 10, 10, 10, 10, 10, 19, 19, 1993 1989 1989 1989 1989 1989 1989 1989 1998 1998

NALBUPHINE HYDROCHLORIDE 1.5MG/ML ABBOTT 20MG/ML 10MG/ML ASTRAZENECA 10MG/ML 10MG/ML 20MG/ML 20MG/ML 20MG/ML BARR 10MG/ML 20MG/ML NUBAIN ENDO PHARMS 10MG/ML 20MG/ML

May 27, 1982

NALIDIXIC ACID
SUSPENSION; ORAL NEGGRAM SANOFI AVENTIS US TABLET; ORAL NALIDIXIC ACID MUTUAL PHARM

250MG/5ML

N017430

001

WATSON LABS

250MG 500MG 1GM 250MG 500MG 1GM 250MG 500MG 1GM

A070270 A070271 A070272 A071936 A072061 A071919 N014214 N014214 N014214

001 001 001 001 001 001 002 004 005

Jun Jun Jun Jun Jun Jun

29, 29, 29, 29, 29, 29,

1988 1988 1988 1988 1988 1988

NEGGRAM SANOFI AVENTIS US

NALMEFENE HYDROCHLORIDE
INJECTABLE; INJECTION REVEX BAXTER HLTHCARE CORP

EQ 0.1MG BASE/ML EQ 1MG BASE/ML

N020459 N020459

001 002

Apr 17, 1995 Apr 17, 1995

NALOXONE HYDROCHLORIDE
INJECTABLE; INJECTION NALOXONE BAXTER HLTHCARE

WYETH AYERST

0.4MG/ML 0.4MG/ML 0.4MG/ML 0.02MG/ML 0.02MG/ML 0.4MG/ML 0.4MG/ML 0.02MG/ML 0.02MG/ML 0.4MG/ML 1MG/ML 0.02MG/ML 0.02MG/ML 0.02MG/ML 0.02MG/ML 0.02MG/ML

A070298 A070299 A070496 A070188 A070189 A070190 A070191 A070648 A070661 A070649 A071604 A072081 A072082 A072083 A072084 A072085

001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001

Sep Sep Sep Sep Sep Sep Sep Nov Nov Nov Dec Apr Apr Apr Apr Apr

24, 24, 24, 24, 24, 24, 24, 17, 17, 17, 16, 11, 11, 11, 11, 11,

1986 1986 1986 1986 1986 1986 1986 1986 1986 1986 1988 1989 1989 1989 1989 1989

NALOXONE HYDROCHLORIDE ABRAXIS PHARM

ASTRAZENECA

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

NALOXONE HYDROCHLORIDE
INJECTABLE; INJECTION NALOXONE HYDROCHLORIDE ASTRAZENECA

6 - 238 (of 346)

BAXTER HLTHCARE

HOSPIRA

INTL MEDICATION MARSAM PHARMS LLC SMITH AND NEPHEW

SOLOPAK WATSON LABS NARCAN BRISTOL MYERS SQUIBB

0.4MG/ML 0.4MG/ML 0.4MG/ML 0.4MG/ML 0.4MG/ML 1MG/ML 1MG/ML 1MG/ML 0.02MG/ML 1MG/ML 1MG/ML 1MG/ML 0.02MG/ML 0.02MG/ML 0.02MG/ML 0.4MG/ML 0.4MG/ML 1MG/ML 0.4MG/ML 0.02MG/ML 0.4MG/ML 0.4MG/ML 0.02MG/ML 0.4MG/ML 0.4MG/ML 0.4MG/ML 1MG/ML 1MG/ML 0.02MG/ML 0.4MG/ML 1MG/ML

A072086 A072087 A072088 A072089 A072090 A072091 A072092 A072093 A071272 A071273 A071274 A071287 A070171 A070252 A070253 A070255 A070417 A072115 A071811 A071671 A071681 A071682 A071672 A071683 A071339 A071083 A071084 A071311 N016636 N016636 N016636

001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 002 001 003

Apr Apr Apr Apr Apr Apr Apr Apr May May May May Sep Jan Jan Jan Sep Apr Jul Nov Nov Nov Nov Nov Nov

11, 11, 11, 11, 11, 11, 11, 11, 24, 24, 24, 24, 24, 16, 16, 07, 24, 27, 19, 17, 17, 17, 17, 17, 18,

1989 1989 1989 1989 1989 1989 1989 1989 1988 1988 1988 1988 1986 1987 1987 1987 1986 1988 1988 1987 1987 1987 1987 1987 1987

Jul 28, 1988 Jul 28, 1988 Jul 28, 1988

ENDO PHARMS

Jun 14, 1982

NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE

TABLET; ORAL TALWIN NX SANOFI AVENTIS US

EQ 0.5MG BASE;EQ 50MG BASE

N018733

001

Dec 16, 1982

NANDROLONE DECANOATE
INJECTABLE; INJECTION DECA-DURABOLIN ORGANON USA INC

50MG/ML 100MG/ML 200MG/ML 100MG/ML 200MG/ML 100MG/ML 50MG/ML 50MG/ML 50MG/ML 100MG/ML 100MG/ML 200MG/ML

N013132 N013132 N013132 A088290 A088317 A087519 A086385 A087598 A088554 A086598 A087599 A088128

001 002 003 001 001 001 001 001 001 001 001 001

Jun 12, 1986 Jun 12, 1986 Jun 12, 1986 Oct Oct Sep Jan Oct Feb Jan Oct Dec 03, 14, 28, 13, 06, 10, 13, 06, 05, 1983 1983 1983 1984 1983 1986 1984 1983 1983

NANDROLONE DECANOATE ABRAXIS PHARM AKORN WATSON LABS

NANDROLONE PHENPROPIONATE
INJECTABLE; INJECTION DURABOLIN ORGANON USA INC

25MG/ML 50MG/ML

N011891 N011891

001 002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

NANDROLONE PHENPROPIONATE
INJECTABLE; INJECTION NANDROLONE PHENPROPIONATE WATSON LABS 25MG/ML 50MG/ML

6 - 239 (of 346)

A086386 A087488

001 001

Jun 17, 1983 Jun 17, 1983

NAPHAZOLINE HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC NAFAZAIR BAUSCH AND LOMB 0.1% PHARMAFAIR 0.1% NAPHCON FORTE ALCON 0.1% OPCON BAUSCH AND LOMB 0.1% VASOCON NOVARTIS 0.1%

A040073 A088101 A080229 A087506 A080235

001 001 001 001 002

May 25, 1994 Apr 15, 1983

Mar 24, 1983

NAPROXEN
TABLET; ORAL NAPROXEN DAVA PHARMS INC

250MG 375MG 500MG HAMILTON PHARMS 250MG 375MG 500MG IVAX SUB TEVA PHARMS 250MG 375MG 500MG PLIVA 250MG 375MG 500MG PUREPAC PHARM 250MG 375MG 500MG ROXANE 250MG 375MG 500MG TEVA 250MG 250MG 375MG 375MG 500MG 500MG TEVA PHARMS 250MG 375MG 500MG WATSON LABS 250MG 375MG 500MG TABLET, DELAYED RELEASE; ORAL NAPROXEN ACTAVIS ELIZABETH 375MG 500MG

A074105 A074105 A074105 A074110 A074110 A074110 A074111 A074111 A074111 A074182 A074182 A074182 A074263 A074263 A074263 A074211 A074211 A074211 A074129 A074216 A074129 A074216 A074129 A074216 A074207 A074207 A074207 A074163 A074163 A074163

001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 001 001 002 002 003 003 001 002 003 001 002 003

Dec Dec Dec Oct Oct Oct Feb Feb Feb Jun Jun Jun Dec Dec Dec Feb Feb Feb Dec Apr Dec Apr Dec Apr Dec Dec Dec Feb Feb Feb

21, 21, 21, 30, 30, 30, 28, 28, 28, 27, 27, 27, 21, 21, 21, 28, 28, 28, 21, 11, 21, 11, 21, 11, 21, 21, 21, 10, 10, 10,

1993 1993 1993 1992 1992 1992 1995 1995 1995 1996 1996 1996 1993 1993 1993 1994 1994 1994 1993 1996 1993 1996 1993 1996 1993 1993 1993 1995 1995 1995

A074936 A074936

001 002

Feb 24, 1998 Feb 24, 1998

NAPROXEN SODIUM
TABLET; ORAL NAPROXEN SODIUM ABLE HAMILTON PHARMS

EQ EQ EQ EQ

250MG 500MG 250MG 500MG

BASE BASE BASE BASE

A076544 A076544 A074106 A074106

001 002 001 002

Aug Aug Aug Aug

22, 22, 31, 31,

2003 2003 1993 1993

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

NAPROXEN SODIUM
TABLET; ORAL NAPROXEN SODIUM IVAX SUB TEVA PHARMS

6 - 240 (of 346)

EQ 250MG EQ 500MG MYLAN EQ 250MG EQ 500MG PLIVA EQ 250MG EQ 500MG PUREPAC PHARM EQ 250MG EQ 500MG ROXANE EQ 250MG EQ 500MG SANDOZ EQ 250MG EQ 250MG EQ 500MG EQ 500MG TEVA EQ 250MG EQ 500MG TEVA PHARMS EQ 250MG EQ 500MG WATSON LABS EQ 250MG EQ 500MG TABLET, EXTENDED RELEASE; ORAL NAPROXEN SODIUM WATSON LABS FLORIDA EQ 375MG EQ 500MG

BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE

A074230 A074230 A074367 A074367 A074242 A074242 A074319 A074319 A074257 A074257 A074162 A074495 A074162 A074495 A074142 A074142 A074289 A074289 A074195 A074195

001 002 001 002 001 002 001 002 001 002 001 001 002 002 001 002 001 002 001 002

Mar Mar Aug Aug Jun Jun Mar Mar Dec Dec Dec Dec Dec Dec Dec Dec Jan Jan Dec Dec

14, 14, 31, 31, 20, 20, 20, 20, 21, 21, 21, 05, 21, 05, 21, 21, 27, 27, 21, 21,

1995 1995 1994 1994 1996 1996 1995 1995 1993 1993 1993 1994 1993 1994 1993 1993 1994 1994 1993 1993

BASE BASE

A075416 A075416

002 001

Apr 23, 2003 Aug 27, 2002

NEDOCROMIL SODIUM
AEROSOL, METERED; INHALATION TILADE KING PHARMS 1.75MG/INH SOLUTION; INHALATION TILADE SANOFI AVENTIS US 0.5%

N019660

001

Dec 30, 1992

N020750

001

Oct 01, 1997

NEFAZODONE HYDROCHLORIDE
TABLET; ORAL NEFAZODONE HYDROCHLORIDE IVAX SUB TEVA PHARMS 50MG 100MG 150MG 200MG 250MG MYLAN 100MG 150MG 200MG 250MG ROXANE 50MG 100MG 150MG 200MG 250MG SANDOZ 50MG 50MG 100MG 100MG 150MG 150MG 200MG 200MG 250MG 250MG

A075763 A075763 A075763 A075763 A075763 A076129 A076129 A076129 A076129 A076196 A076196 A076196 A076196 A076196 A076072 A076302 A076072 A076302 A076072 A076302 A076072 A076302 A076072 A076302

001 002 003 004 005 002 003 004 005 001 002 003 004 005 001 001 002 002 003 003 004 004 005 005

Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep

16, 16, 16, 16, 16, 16, 16, 16, 16, 16, 16, 16, 16, 16, 16, 16, 16, 16, 16, 16, 16, 16, 16, 16,

2003 2003 2003 2003 2003 2003 2003 2003 2003 2003 2003 2003 2003 2003 2003 2003 2003 2003 2003 2003 2003 2003 2003 2003

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

NEFAZODONE HYDROCHLORIDE
TABLET; ORAL NEFAZODONE HYDROCHLORIDE WATSON LABS 100MG 150MG 200MG 250MG SERZONE BRISTOL MYERS SQUIBB 50MG 100MG 150MG 200MG 250MG 300MG

6 - 241 (of 346)

A076073 A076073 A076073 A076073 N020152 N020152 N020152 N020152 N020152 N020152

002 003 004 005 001 002 003 004 005 006

Sep Sep Sep Sep Dec Dec Dec Dec Dec Dec

16, 16, 16, 16, 22, 22, 22, 22, 22, 22,

2003 2003 2003 2003 1994 1994 1994 1994 1994 1994

NEOMYCIN SULFATE
SOLUTION; ORAL MYCIFRADIN PHARMACIA AND UPJOHN TABLET; ORAL MYCIFRADIN PHARMACIA AND UPJOHN NEOBIOTIC PFIZER NEOMYCIN SULFATE BRISTOL MYERS SQUIBB LANNETT LILLY ROXANE SANDOZ

EQ 87.5MG BASE/5ML

N050285

001

EQ 350MG BASE EQ 350MG BASE 500MG 500MG 500MG 500MG 500MG

A060520 A060475 A060365 A060607 A060385 A062173 A061586

001 001 001 001 001 001 001

NEOMYCIN SULFATE; POLYMYXIN B SULFATE

CREAM; TOPICAL NEOSPORIN GLAXOSMITHKLINE EQ OINTMENT; OPHTHALMIC STATROL ALCON EQ SOLUTION/DROPS; OPHTHALMIC STATROL ALCON EQ EQ

3.5MG BASE/GM;10,000 UNITS/GM

N050176

002

Jan 14, 1985

3.5MG BASE/GM;10,000 UNITS/GM

N050344

002

3.5MG BASE/ML;16,250 UNITS/ML 3.5MG BASE/ML;16,250 UNITS/ML

A062339 N050456

001 001

Nov 30, 1984

NEOMYCIN SULFATE; PREDNISOLONE ACETATE

OINTMENT; OPHTHALMIC NEO-DELTA-CORTEF PHARMACIA AND UPJOHN

EQ 3.5MG BASE/GM;0.25% EQ 3.5MG BASE/GM;0.5% SUSPENSION/DROPS; OPHTHALMIC NEO-DELTA-CORTEF PHARMACIA AND UPJOHN EQ 3.5MG BASE/ML;0.25%

A061039 A061039

002 001

A061037

001

NEOMYCIN SULFATE; PREDNISOLONE SODIUM PHOSPHATE

OINTMENT; OPHTHALMIC NEO-HYDELTRASOL MERCK

EQ 3.5MG BASE/GM;EQ 0.25% PHOSPHATE

N050378

001

NEOMYCIN SULFATE; TRIAMCINOLONE ACETONIDE

CREAM; TOPICAL MYTREX A SAVAGE LABS EQ 3.5MG BASE/GM;0.1% NEOMYCIN SULFATE-TRIAMCINOLONE ACETONIDE FOUGERA EQ 3.5MG BASE/GM;0.1%

A062598 A062600

001 001

Jul 21, 1986 Jul 21, 1986

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

NEOMYCIN SULFATE; TRIAMCINOLONE ACETONIDE
CREAM; TOPICAL NEOMYCIN SULFATE-TRIAMCINOLONE ACETONIDE PHARMADERM EQ 3.5MG BASE/GM;0.1% OINTMENT; TOPICAL MYTREX A SAVAGE LABS EQ 3.5MG BASE/GM;0.1% NEOMYCIN SULFATE-TRIAMCINOLONE ACETONIDE FOUGERA EQ 3.5MG BASE/GM;0.1% PHARMADERM EQ 3.5MG BASE/GM;0.1%

6 - 242 (of 346)

A062595

001

Jul 21, 1986

A062609 A062608 A062607

001 001 001

May 23, 1986 May 23, 1986 May 23, 1986

NETILMICIN SULFATE
INJECTABLE; INJECTION NETROMYCIN SCHERING

EQ 10MG BASE/ML EQ 25MG BASE/ML EQ 100MG BASE/ML

N050544 N050544 N050544

001 002 003

Feb 28, 1983 Feb 28, 1983 Feb 28, 1983

NIACIN
CAPSULE; ORAL WAMPOCAP MEDPOINTE PHARM HLC TABLET; ORAL NIACIN EVERYLIFE HALSEY IMPAX LABS IVAX SUB TEVA PHARMS MK LABS PUREPAC PHARM SANDOZ TABLICAPS WATSON LABS

500MG

N011073

003

WEST WARD NICOLAR SANOFI AVENTIS US 500MG TABLET, EXTENDED RELEASE; ORAL NIACIN BARR 500MG 750MG 1GM NIASPAN ABBOTT 375MG NIASPAN TITRATION STARTER PACK ABBOTT 375MG;500MG;750MG

500MG 500MG 500MG 500MG 500MG 500MG 500MG 500MG 500MG 500MG 500MG 500MG

A083203 A083453 A083115 A083180 A083525 A083271 A083306 A084237 A083136 A083305 A085172 A083718 A083823

001 001 001 001 001 001 001 001 001 001 001 001 001

A076378 A076378 A076250 N020381 N020381

001 002 001 001 005

Apr 26, 2005 Apr 26, 2005 Apr 14, 2005 Jul 28, 1997 Jul 28, 1997

NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; TYROSINE

SUSPENSION; ORAL TPN INTL MINERALS

15MG/5ML;3.75MG/5ML;600MG/5ML

N008378

003

NICARDIPINE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL CARDENE SR EKR THERAP 45MG

N020005

002

Feb 21, 1992

NICLOSAMIDE
TABLET, CHEWABLE; ORAL NICLOCIDE BAYER PHARMS

500MG

N018669

001

May 14, 1982

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

NICOTINE
FILM, EXTENDED RELEASE; TRANSDERMAL NICOTROL MCNEIL CONS 15MG/16HR PROSTEP AVEVA 11MG/24HR 22MG/24HR

6 - 243 (of 346)

N020536 N019983 N019983

001 003 004

Jul 03, 1996 Dec 23, 1998 Dec 23, 1998

NICOTINE POLACRILEX
GUM, CHEWING; BUCCAL NICOTINE POLACRILEX WATSON LABS

EQ 2MG BASE EQ 4MG BASE

A076568 A076569

001 002

Jul 29, 2004 Jul 29, 2004

NIFEDIPINE
CAPSULE; ORAL ADALAT BAYER PHARMS NIFEDIPINE CATALENT CHASE LABS NJ TEVA PROCARDIA PFIZER TABLET, EXTENDED RELEASE; NIFEDIPINE MARTEC USA LLC MYLAN

10MG 20MG 20MG 10MG 20MG 10MG 20MG ORAL 90MG 30MG

N019478 N019478 A074045 A072409 A073421 A072651 N018482

001 002 001 001 001 001 002

Nov 27, 1985 Sep 17, 1986 Apr Jul Jun Feb 30, 04, 19, 19, 1992 1990 1991 1992

Jul 24, 1986

A075414 A075108

003 001

Mar 23, 2004 Dec 17, 1999

NILUTAMIDE
TABLET; ORAL NILANDRON SANOFI AVENTIS US

50MG

N020169

001

Sep 19, 1996

NIMODIPINE
CAPSULE; ORAL NIMOTOP BAYER PHARMS

30MG

N018869

001

Dec 28, 1988

NISOLDIPINE
TABLET, EXTENDED RELEASE; ORAL SULAR SHIONOGI INC 10MG 20MG 30MG 40MG

N020356 N020356 N020356 N020356

001 002 003 004

Feb Feb Feb Feb

02, 02, 02, 02,

1995 1995 1995 1995

NITROFURANTOIN
CAPSULE; ORAL NITROFURANTOIN WATSON LABS TABLET; ORAL FURADANTIN PROCTER AND GAMBLE FURALAN LANNETT NITROFURANTOIN ELKINS SINN

50MG 100MG

A084326 A084326

001 002

50MG 100MG 50MG 100MG 50MG

N008693 N008693 A080017 A080017 A080003

001 002 001 002 001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

NITROFURANTOIN
TABLET; ORAL NITROFURANTOIN ELKINS SINN IVAX SUB TEVA PHARMS SANDOZ WATSON LABS

6 - 244 (of 346)

WHITEWORTH TOWN PLSN

100MG 50MG 100MG 50MG 100MG 50MG 50MG 100MG 100MG 100MG

A080003 A080078 A080078 A080043 A080043 A080447 A085797 A080447 A085796 A084085

002 002 001 001 002 001 001 002 001 002

NITROFURANTOIN SODIUM
INJECTABLE; INJECTION IVADANTIN PROCTER AND GAMBLE

EQ 180MG BASE/VIAL

N012402

001

NITROFURANTOIN, MACROCRYSTALLINE
CAPSULE; ORAL NITROFURANTOIN MYLAN SANDOZ

100MG 25MG 50MG 100MG NITROFURANTOIN MACROCRYSTALLINE WATSON LABS 50MG 100MG

A074967 A074336 A074336 A074336 A070248 A070249

002 001 002 003 001 001

Jul Jan Jan Jan

09, 25, 25, 25,

1997 1995 1995 1995

Jun 24, 1988 Jun 24, 1988

NITROFURAZONE
CREAM; TOPICAL FURACIN SHIRE DRESSING; TOPICAL ACTIN-N SHERWOOD MEDCL OINTMENT; TOPICAL FURACIN SHIRE NITROFURAZONE AMBIX LANNETT PERRIGO NEW YORK TARO WENDT POWDER; TOPICAL FURACIN SHIRE SOLUTION; TOPICAL NITROFURAZONE PERRIGO NEW YORK WENDT

0.2%

A083789

001

0.2%

N017343

001

0.2% 0.2% 0.2% 0.2% 0.2% 0.2%

N005795 A086077 A084393 A084968 A086156 A086766

001 001 001 001 001 001

0.2%

A083791

001

0.2% 0.2%

A085130 A087081

001 001

NITROGLYCERIN
AEROSOL; SUBLINGUAL
NITROLINGUAL
POHL BOSKAMP 0.4MG/SPRAY FILM, EXTENDED RELEASE; TRANSDERMAL NITROGLYCERIN MYLAN TECHNOLOGIES 0.1MG/HR 0.2MG/HR 0.4MG/HR 0.6MG/HR

N018705

001

Oct 31, 1985

A074992 A074992 A074992 A074992

004 003 002 001

Nov Nov Nov Nov

12, 12, 12, 12,

1999 1999 1999 1999

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

NITROGLYCERIN
FILM, EXTENDED RELEASE; TRANSDERMAL TRANSDERM-NITRO NOVARTIS 0.1MG/HR 0.2MG/HR 0.4MG/HR 0.6MG/HR 0.8MG/HR INJECTABLE; INJECTION NITRO IV POHL BOSKAMP 5MG/ML NITRO-BID SANOFI AVENTIS US 5MG/ML 10MG/ML NITROGLYCERIN ABRAXIS PHARM 5MG/ML 5MG/ML INTL MEDICATION 5MG/ML LUITPOLD 5MG/ML SMITH AND NEPHEW 5MG/ML 5MG/ML NITROGLYCERIN IN DEXTROSE 5% HOSPIRA 0.1MG/ML NITROL RORER 0.8MG/ML NITRONAL POHL BOSKAMP 1MG/ML NITROSTAT PARKE DAVIS 0.8MG/ML 5MG/ML 5MG/ML 10MG/ML 10MG/ML TRIDIL HOSPIRA 0.5MG/ML 5MG/ML

6 - 245 (of 346)

N020144 N020144 N020144 N020144 N020144

001 002 003 004 005

Feb Feb Feb Feb Feb

27, 27, 27, 27, 27,

1996 1996 1996 1996 1996

N018672 N018621 A071159 A070077 A071203 A070026 A071492 A070633 A070634 A074083 N018774 N018672 N018588 A070863 N018588 A070871 A070872 N018537 N018537

002 001 001 001 001 001 001 001 001 001 001 001 001 001 002 001 001 002 001

Aug 30, 1983 Jan 05, 1982 Feb 28, 1990 Dec May Sep May Jun Jun 13, 08, 10, 24, 19, 19, 1985 1987 1985 1988 1986 1986

Oct 26, 1994 Jan 19, 1983 Aug 30, 1983

Jan Dec Jan Jan

08, 23, 08, 08,

1987 1983 1987 1987

Jun 16, 1983

NIZATIDINE
CAPSULE; ORAL NIZATIDINE IVAX SUB TEVA PHARMS

150MG 300MG

A075461 A075461

001 002

Jul 08, 2002 Jul 08, 2002

NONOXYNOL-9
AEROSOL; VAGINAL DELFEN PERSONAL PRODS

12.5%

N014349

002

NOREPINEPHRINE BITARTRATE
INJECTABLE; INJECTION NOREPINEPHRINE BITARTRATE METRICS PHARM EQ 1MG BASE/ML

A040522

001

Sep 30, 2004

NOREPINEPHRINE BITARTRATE; PROCAINE HYDROCHLORIDE; PROPOXYCAINE HYDROCHLORIDE

INJECTABLE; INJECTION RAVOCAINE AND NOVOCAIN W/ LEVOPHED EASTMAN KODAK EQ 0.033MG BASE/ML;2%;0.4%

N008592

003

NORETHINDRONE
TABLET; ORAL NORLUTIN PARKE DAVIS

5MG

N010895

002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

NORETHINDRONE ACETATE
TABLET; ORAL NORLUTATE PARKE DAVIS

6 - 246 (of 346)

5MG

N012184

002

NORFLOXACIN
SOLUTION/DROPS; OPHTHALMIC CHIBROXIN MERCK 0.3%

N019757

001

Jun 17, 1991

NORGESTREL
TABLET; ORAL OVRETTE WYETH PHARMS

0.075MG

N017031

001

NORTRIPTYLINE HYDROCHLORIDE
CAPSULE; ORAL AVENTYL HYDROCHLORIDE LILLY

EQ 10MG EQ 25MG NORTRIPTYLINE HYDROCHLORIDE SANDOZ EQ 10MG EQ 10MG EQ 25MG EQ 25MG EQ 50MG EQ 50MG EQ 75MG EQ 75MG TEVA EQ 10MG EQ 25MG EQ 50MG EQ 75MG SOLUTION; ORAL PAMELOR MALLINCKRODT INC EQ 10MG

BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE

N014684 N014684 A074054 A074835 A074054 A074835 A074054 A074835 A074054 A074835 A073667 A073667 A073667 A073667

001 002 001 001 002 002 003 003 004 004 001 002 003 004 Dec Jun Dec Jun Dec Jun Dec Jun Apr Apr Apr Apr 31, 30, 31, 30, 31, 30, 31, 30, 11, 11, 11, 11, 1992 1997 1992 1997 1992 1997 1992 1997 1996 1996 1996 1996

BASE/5ML

N018012

001

NYSTATIN
CREAM; TOPICAL CANDEX BAYER PHARMS MYCOSTATIN BRISTOL MYERS SQUIBB MYKINAC ALPHARMA US PHARMS NILSTAT LEDERLE NYSTATIN TARO TEVA LOTION; TOPICAL CANDEX BAYER PHARMS OINTMENT; TOPICAL MYCOSTATIN WESTWOOD SQUIBB MYKINAC ALPHARMA US PHARMS NILSTAT LEDERLE PASTILLE; ORAL MYCOSTATIN BRISTOL MYERS SQUIBB

100,000 UNITS/GM 100,000 UNITS/GM 100,000 UNITS/GM 100,000 UNITS/GM 100,000 UNITS/GM 100,000 UNITS/GM

A061810 A060575 A062387 A061445 A062457 A061966

001 001 001 001 001 001 Jul 28, 1983 Jul 29, 1982

100,000 UNITS/ML

N050233

001

100,000 UNITS/GM 100,000 UNITS/GM 100,000 UNITS/GM

A060571 A062731 A061444

001 001 001 Sep 22, 1986

200,000 UNITS

N050619

001

Apr 09, 1987

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DISCONTINUED DRUG PRODUCT LIST

NYSTATIN
POWDER; ORAL BARSTATIN 100 BARLAN NILSTAT DAVA PHARMS INC NYSTATIN PADDOCK LLC POWDER; TOPICAL MYCOSTATIN BRISTOL MYERS SQUIBB SUPPOSITORY; VAGINAL NYSERT WARNER CHILCOTT SUSPENSION; ORAL MYCOSTATIN APOTHECON NYSTATIN ALPHARMA US PHARMS MORTON GROVE PHARMADERM PHARMAFAIR ROXANE TEVA NYSTEX SAVAGE LABS TABLET; ORAL MYCOSTATIN BRISTOL MYERS SQUIBB NILSTAT LEDERLE NYSTATIN HERITAGE PHARMS INC QUANTUM PHARMICS SANDOZ USL PHARMA WATSON LABS TABLET; VAGINAL KOROSTATIN HOLLAND RANTOS MYCOSTATIN BRISTOL MYERS SQUIBB NILSTAT LEDERLE NYSTATIN FOUGERA PHARMADERM QUANTUM PHARMICS SANDOZ TEVA WATSON LABS

6 - 247 (of 346)

100% 100% 100%

A062489 N050576 A062613

001 001 001

Apr 27, 1988 Dec 22, 1983 Nov 26, 1985

100,000 UNITS/GM

A060578

001

100,000 UNITS

N050478

001

100,000 UNITS/ML 100,000 100,000 100,000 100,000 100,000 100,000 100,000 UNITS/ML UNITS/ML UNITS/ML UNITS/ML UNITS/ML UNITS/ML UNITS/ML

A061533 A062571 A062835 A062518 A062541 A062832 A062670 A062776 A062519

001 001 001 001 001 001 001 001 001 Oct Nov Jul Jan Dec Jun Dec 29, 19, 06, 16, 27, 18, 17, 1985 1987 1984 1985 1991 1987 1987

100,000 UNITS/ML

Jul 06, 1984

500,000 UNITS 500,000 UNITS 500,000 500,000 500,000 500,000 500,000 UNITS UNITS UNITS UNITS UNITS

A060574 A061151 A062474 A062525 A062065 A062524 A062402

001 001 001 001 001 001 001 Dec 22, 1983 Oct 29, 1984 Nov 26, 1985 Dec 16, 1982

100,000 UNITS 100,000 UNITS 100,000 UNITS 100,000 100,000 100,000 100,000 100,000 100,000 UNITS UNITS UNITS UNITS UNITS UNITS

A061718 A060577 A061325 A062459 A062460 A062509 A061965 A062502 A062176

001 001 001 001 001 001 001 001 001 Nov 09, 1983 Nov 09, 1983 Apr 03, 1984 Dec 23, 1983

NYSTATIN; TRIAMCINOLONE ACETONIDE

CREAM; TOPICAL MYCOLOG-II APOTHECON MYCO-TRIACET II TEVA MYKACET ACTAVIS MID ATLANTIC MYTREX F SAVAGE LABS

100,000 UNITS/GM;0.1% 100,000 UNITS/GM;0.1% 100,000 UNITS/GM;0.1% 100,000 UNITS/GM;0.1% 100,000 UNITS/GM;0.1%

A060576 A062606 A061954 A062367 A062597

002 001 002 001 001

May 01, 1985 May 15, 1985 Sep 20, 1985 May 28, 1985 Oct 08, 1985

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

NYSTATIN; TRIAMCINOLONE ACETONIDE
CREAM; TOPICAL NYSTATIN AND TRIAMCINOLONE ACETONIDE ALPHARMA US PHARMS 100,000 UNITS/GM;0.1% PERRIGO NEW YORK 100,000 UNITS/GM;0.1% PHARMAFAIR 100,000 UNITS/GM;0.1% TARO 100,000 UNITS/GM;0.1% NYSTATIN-TRIAMCINOLONE ACETONIDE PHARMADERM 100,000 UNITS/GM;0.1% OINTMENT; TOPICAL MYCOLOG-II APOTHECON 100,000 UNITS/GM;0.1% MYCO-TRIACET II TEVA 100,000 UNITS/GM;0.1% MYKACET ACTAVIS MID ATLANTIC 100,000 UNITS/GM;0.1% MYTREX F SAVAGE LABS 100,000 UNITS/GM;0.1% NYSTATIN AND TRIAMCINOLONE ACETONIDE PERRIGO NEW YORK 100,000 UNITS/GM;0.1% PHARMAFAIR 100,000 UNITS/GM;0.1% NYSTATIN-TRIAMCINOLONE ACETONIDE PHARMADERM 100,000 UNITS/GM;0.1%

6 - 248 (of 346)

A063010 A062186 A062657 A062347 A062596

001 002 001 001 001

Dec Jun Jul Mar

20, 06, 30, 30,

1988 1985 1986 1987

Oct 08, 1985

A060572 A062045 A062733 A062601 A062280 A062656 A062603

001 002 001 001 002 001 001

Jun 28, 1985 Nov 26, 1985 Mar 09, 1987 Oct 09, 1985 Oct 10, 1985 Jul 30, 1986 Oct 09, 1985

OFLOXACIN
INJECTABLE; INJECTION FLOXIN ORTHO MCNEIL PHARM

20MG/ML 40MG/ML

N020087 N020087 N020087 N020087 N020087 A075762

002 003 001 004 005 001

Mar 31, 1992 Mar 31, 1992 Mar 31, 1992 Mar 31, 1992 Mar 31, 1992 Jan 16, 2002

FLOXIN IN DEXTROSE 5% ORTHO MCNEIL PHARM 400MG/100ML FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER ORTHO MCNEIL PHARM 4MG/ML 400MG/100ML OFLOXACIN BEDFORD 40MG/ML TABLET; ORAL FLOXIN JANSSEN PHARMS 200MG 300MG 400MG OFLOXACIN LARKEN LABS 200MG 300MG 400MG

N019735 N019735 N019735 A076093 A076093 A076093

001 002 003 001 002 003

Dec 28, 1990 Dec 28, 1990 Dec 28, 1990 Sep 02, 2003 Sep 02, 2003 Sep 02, 2003

ONDANSETRON HYDROCHLORIDE
INJECTABLE; INJECTION ONDANSETRON HYDROCHLORIDE HOSPIRA EQ 2MG BASE/ML ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER HOSPIRA EQ 0.64MG BASE/ML ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE HOSPIRA EQ 2MG BASE/ML ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER GLAXOSMITHKLINE EQ 0.64MG BASE/ML

A076695 A076978 A076696 N020403

001 001 001 001

Dec 26, 2006 Feb 26, 2007 Dec 26, 2006 Jan 31, 1995

ORPHENADRINE CITRATE
TABLET, EXTENDED RELEASE; ORAL NORFLEX MEDICIS 100MG ORPHENADRINE CITRATE ASCOT 100MG

N012157 A088067

001 001 Apr 06, 1983

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

ORPHENADRINE CITRATE
TABLET, EXTENDED RELEASE; ORAL ORPHENADRINE CITRATE SANDOZ 100MG WATSON LABS 100MG

6 - 249 (of 346)

A085046 A084303

001 001

ORPHENADRINE HYDROCHLORIDE
TABLET; ORAL DISIPAL 3M

50MG

N010653

001

OSELTAMIVIR PHOSPHATE
FOR SUSPENSION; ORAL TAMIFLU ROCHE

EQ 12MG BASE/ML

N021246

001

Dec 14, 2000

OXACILLIN SODIUM
CAPSULE; ORAL BACTOCILL GLAXOSMITHKLINE

EQ EQ EQ EQ EQ EQ EQ EQ

250MG 250MG 500MG 500MG 250MG 500MG 250MG 500MG

BASE BASE BASE BASE BASE BASE BASE BASE

A061336 A062241 A061336 A062241 A061450 A061450 A062222 A062222 N050118

001 001 002 002 002 001 001 002 002

OXACILLIN SODIUM APOTHECON TEVA PROSTAPHLIN APOTHECON FOR SOLUTION; ORAL BACTOCILL GLAXOSMITHKLINE OXACILLIN SODIUM APOTHECON TEVA PROSTAPHLIN APOTHECON INJECTABLE; INJECTION BACTOCILL GLAXOSMITHKLINE

EQ 500MG BASE

EQ 250MG BASE/5ML EQ 250MG BASE/5ML EQ 250MG BASE/5ML EQ 250MG BASE/5ML

A062321 A061457 A062252 N050194

001 001 001 001

EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ

500MG BASE/VIAL 1GM BASE/VIAL 1GM BASE/VIAL 2GM BASE/VIAL 2GM BASE/VIAL 4GM BASE/VIAL 10GM BASE/VIAL 250MG BASE/VIAL 500MG BASE/VIAL 1GM BASE/VIAL 2GM BASE/VIAL 4GM BASE/VIAL 250MG BASE/VIAL 500MG BASE/VIAL 1GM BASE/VIAL 2GM BASE/VIAL 4GM BASE/VIAL 10GM BASE/VIAL 125MG BASE/VIAL 250MG BASE/VIAL 500MG BASE/VIAL 1GM BASE/VIAL

A061334 A061334 A062736 A061334 A062736 A061334 A061334 N050195 N050195 N050195 N050195 N050195 A062711 A062711 A062711 A062711 A062711 A062711 A062798 A062798 A062798 A062798

009 006 001 007 002 008 010 001 002 003 004 005 001 002 003 004 005 006 003 004 005 001

Mar Mar Dec Mar Dec Mar

26, 26, 19, 26, 19, 26,

1982 1982 1986 1982 1986 1982

OXACILLIN SODIUM APOTHECON

ELKINS SINN

IBI

Feb Feb Feb Feb Feb Feb Dec Dec Dec Dec

03, 03, 03, 03, 03, 03, 11, 11, 11, 11,

1989 1989 1989 1989 1989 1989 1995 1995 1995 1995

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

OXACILLIN SODIUM
INJECTABLE; INJECTION
OXACILLIN SODIUM
IBI MARSAM PHARMS LLC SANDOZ WATSON LABS

6 - 250 (of 346)

EQ EQ EQ EQ EQ EQ EQ EQ EQ

2GM BASE/VIAL 10GM BASE/VIAL 250MG BASE/VIAL 500MG BASE/VIAL 250MG BASE/VIAL 500MG BASE/VIAL 1GM BASE/VIAL 2GM BASE/VIAL 4GM BASE/VIAL

A062798 A062984 A061490 A061490 A062856 A062856 A062856 A062856 A062856

002 001 001 002 001 002 003 004 005

Dec 11, 1995

Sep 29, 1988

Oct Oct Oct Oct Oct

26, 26, 26, 26, 26,

1988 1988 1988 1988 1988

OXALIPLATIN
INJECTABLE; IV (INFUSION) ELOXATIN 50MG/VIAL SANOFI AVENTIS US 100MG/VIAL

N021492 N021492

001 002

Aug 09, 2002 Aug 09, 2002

OXAMNIQUINE
CAPSULE; ORAL VANSIL PFIZER

250MG

N018069

001

OXANDROLONE
TABLET; ORAL OXANDROLONE ROXANE

2.5MG 10MG

A077249 A077249

001 002

Jul 10, 2007 Jul 10, 2007

OXAPROZIN
TABLET; ORAL OXAPROZIN ACTAVIS ELIZABETH MYLAN SANDOZ

600MG 600MG 600MG 600MG

A075843 A075851 A075842 A075850

001 001 001 001

Oct Aug Apr Apr

03, 17, 12, 27,

2001 2001 2001 2001

OXAPROZIN POTASSIUM
TABLET; ORAL DAYPRO ALTA GD SEARLE

600MG

N020776

001

Oct 17, 2002

OXAZEPAM
CAPSULE; ORAL OXAZEPAM AM THERAP

MUTUAL PHARM

MYLAN

10MG 15MG 30MG 10MG 15MG 30MG 10MG 15MG 30MG 10MG 15MG 30MG 10MG 15MG 30MG

A071955 A071956 A071957 A071026 A071026 A071026 A071713 A071714 A071715 N015539 N015539 N015539 A070650 A070640 A070641

001 001 001 002 003 001 001 001 001 002 004 006 001 001 001

Mar Mar Mar Aug Aug Aug Oct Oct Oct

03, 03, 03, 10, 10, 10, 20, 20, 20,

1988 1988 1988 1987 1987 1987 1987 1987 1987

SERAX ALPHARMA US PHARMS

ZAXOPAM QUANTUM PHARMICS

Mar 01, 1988 Mar 01, 1988 Mar 01, 1988

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

OXAZEPAM
TABLET; ORAL OXAZEPAM MUTUAL PHARM PARKE DAVIS WATSON LABS SERAX ALPHARMA US PHARMS

6 - 251 (of 346)

15MG 15MG 15MG 15MG

A070683 A071508 A071494 N015539

001 001 001 008

Jan 16, 1987 Feb 02, 1987 Apr 21, 1987

OXPRENOLOL HYDROCHLORIDE
CAPSULE; ORAL TRASICOR NOVARTIS

20MG 40MG 80MG 160MG

N018166 N018166 N018166 N018166

001 002 003 004

Dec Dec Dec Dec

28, 28, 28, 28,

1983 1983 1983 1983

OXTRIPHYLLINE
SOLUTION; ORAL CHOLEDYL PARKE DAVIS 100MG/5ML OXTRIPHYLLINE MORTON GROVE 100MG/5ML SYRUP; ORAL CHOLEDYL PARKE DAVIS 50MG/5ML OXTRIPHYLLINE PEDIATRIC MORTON GROVE 50MG/5ML TABLET, DELAYED RELEASE; ORAL CHOLEDYL PARKE DAVIS 100MG 200MG OXTRIPHYLLINE WATSON LABS 100MG 200MG

N009268 A088243

012 001

Nov 27, 1984 Dec 05, 1983

N009268 A088242

011 001 Dec 05, 1983

N009268 N009268 A087866 A087835

003 007 001 001 Aug 25, 1983 Aug 25, 1983

OXYBUTYNIN CHLORIDE
SYRUP; ORAL DITROPAN ORTHO MCNEIL JANSSEN TABLET; ORAL OXYBUTYNIN CHLORIDE QUANTUM PHARMICS USL PHARMA WATSON LABS

5MG/5ML

N018211

001

5MG 5MG 5MG

A072296 A070746 A072485

001 001 001

Dec 08, 1988 Mar 10, 1988 Apr 19, 1989

OXYCODONE HYDROCHLORIDE
TABLET, EXTENDED RELEASE; ORAL OXYCONTIN PURDUE PHARMA LP 10MG 15MG 20MG 30MG 40MG 60MG 80MG 160MG ROXICODONE ROXANE 10MG 30MG

N020553 N020553 N020553 N020553 N020553 N020553 N020553 N020553 N020932 N020932

001 006 002 007 003 008 004 005 001 002

Dec Sep Dec Sep Dec Sep Jan Mar

12, 18, 12, 18, 12, 18, 06, 15,

1995 2006 1995 2006 1995 2006 1997 2000

Oct 26, 1998 Oct 26, 1998

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

OXYMORPHONE HYDROCHLORIDE
INJECTABLE; INJECTION OPANA ENDO PHARMS SUPPOSITORY; RECTAL NUMORPHAN ENDO PHARMS TABLET, EXTENDED RELEASE; OPANA ER ENDO PHARMS

6 - 252 (of 346)

1.5MG/ML

N011707

001

5MG ORAL 7.5MG 15MG

N011738

004

N021610 N021610

005 006

Feb 29, 2008 Feb 29, 2008

OXYPHENBUTAZONE
TABLET; ORAL OXYPHENBUTAZONE WATSON LABS TANDEARIL NOVARTIS

100MG 100MG

A088399 N012542

001 004

Sep 17, 1984 Sep 03, 1982

OXYPHENCYCLIMINE HYDROCHLORIDE
TABLET; ORAL DARICON PFIZER

10MG

N011612

001

OXYPHENONIUM BROMIDE
TABLET; ORAL ANTRENYL NOVARTIS

5MG

N008492

002

OXYTETRACYCLINE
TABLET; ORAL TERRAMYCIN PFIZER

250MG

N050287

001

OXYTETRACYCLINE CALCIUM
SYRUP; ORAL TERRAMYCIN PFIZER

EQ 125MG BASE/5ML

A060595

001

OXYTETRACYCLINE HYDROCHLORIDE
CAPSULE; ORAL OXY-KESSO-TETRA FERRANTE EQ 250MG OXYTETRACYCLINE HYDROCHLORIDE IMPAX LABS EQ 250MG PROTER EQ 250MG PUREPAC PHARM EQ 250MG WEST WARD EQ 250MG TERRAMYCIN PFIZER EQ 125MG EQ 250MG INJECTABLE; INJECTION TERRAMYCIN PFIZER EQ 250MG EQ 500MG

BASE BASE BASE BASE BASE BASE BASE

A060179 A060760 A060869 A060634 A060770 N050286 N050286

001 001 001 001 001 001 002

BASE/VIAL BASE/VIAL

A060586 A060586

001 002

OXYTETRACYCLINE HYDROCHLORIDE; POLYMYXIN B SULFATE

OINTMENT; OTIC TERRAMYCIN W/ POLYMYXIN PFIZER EQ 5MG BASE/GM;10,000 UNITS/GM TABLET; VAGINAL TERRAMYCIN-POLYMYXIN PFIZER EQ 100MG BASE;100,000 UNITS

A061841

001

A061009

001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

OXYTOCIN
INJECTABLE; INJECTION OXYTOCIN 10 USP UNITS IN DEXTROSE 5% ABBOTT 1USP UNITS/100ML 2USP UNITS/100ML OXYTOCIN 20 USP UNITS IN DEXTROSE 5% ABBOTT 2USP UNITS/100ML OXYTOCIN 5 USP UNITS IN DEXTROSE 5% ABBOTT 1USP UNITS/100ML SYNTOCINON NOVARTIS 10USP UNITS/ML SOLUTION; NASAL SYNTOCINON NOVARTIS 40USP UNITS/ML

6 - 253 (of 346)

N019185 N019185 N019185 N019185 N018245

004 003 002 001 001

Mar 29, 1985 Mar 29, 1985 Mar 29, 1985 Mar 29, 1985

N012285

001

PACLITAXEL
INJECTABLE; INJECTION PACLITAXEL HOSPIRA PLIVA LACHEMA TEVA PARENTERAL TAXOL BRISTOL MYERS SQUIBB

6MG/ML 6MG/ML 6MG/ML 6MG/ML

A076233 A077413 A075297 N020262

001 001 001 001

Aug 01, 2002 Mar 12, 2008 Jan 25, 2002 Dec 29, 1992

PALIPERIDONE
TABLET, EXTENDED RELEASE; ORAL INVEGA JANSSEN PHARMS 12MG

N021999

004

Dec 19, 2006

PALONOSETRON HYDROCHLORIDE
CAPSULE; ORAL ALOXI HELSINN HLTHCARE

EQ 0.5MG BASE

N022233

001

Aug 22, 2008

PAMIDRONATE DISODIUM
INJECTABLE; INJECTION AREDIA NOVARTIS PAMIDRONATE DISODIUM AESGEN

60MG/VIAL 90MG/VIAL 30MG/VIAL 90MG/VIAL

N020036 N020036 A075594 A075594

003 004 001 002

May 06, 1993 May 06, 1993 May 06, 2002 May 06, 2002

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
CAPSULE; ORAL COTAZYM ORGANON USA INC

30,000USP UNITS;8,000USP UNITS;30,000USP UNITS

N020580

001

Dec 09, 1996

PANCURONIUM BROMIDE
INJECTABLE; INJECTION

PANCURONIUM BROMIDE

ASTRAZENECA

ELKINS SINN

HOSPIRA PAVULON ORGANON USA INC

1MG/ML 2MG/ML 2MG/ML 2MG/ML 1MG/ML 2MG/ML 2MG/ML 2MG/ML 1MG/ML 2MG/ML

A072210 A072211 A072212 A072213 A072058 A072059 A072060 A072321 N017015 N017015

001 001 001 001 001 001 001 001 002 001

Mar Mar Mar Mar Mar Mar Mar Jan

31, 31, 31, 31, 23, 23, 23, 19,

1988 1988 1988 1988 1988 1988 1988 1989

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

PARAMETHADIONE
CAPSULE; ORAL PARADIONE ABBOTT SOLUTION; ORAL PARADIONE ABBOTT

6 - 254 (of 346)

150MG 300MG

N006800 N006800

003 001

300MG/ML

N006800

002

PARAMETHASONE ACETATE
TABLET; ORAL HALDRONE LILLY

1MG 2MG

N012772 N012772

005 006

PARGYLINE HYDROCHLORIDE
TABLET; ORAL EUTONYL ABBOTT

10MG 25MG 50MG

N013448 N013448 N013448

002 003 004

PAROMOMYCIN SULFATE
CAPSULE; ORAL HUMATIN KING PFIZER PARKEDALE SYRUP; ORAL HUMATIN PARKE DAVIS

EQ 250MG BASE EQ 250MG BASE

A062310 A060521

001 001

EQ 125MG BASE/5ML

A060522

001

PAROXETINE HYDROCHLORIDE
CAPSULE; ORAL PAXIL GLAXOSMITHKLINE

EQ EQ EQ EQ

10MG 20MG 30MG 40MG

BASE BASE BASE BASE

N020885 N020885 N020885 N020885

001 002 003 004

Oct Oct Oct Oct

09, 09, 09, 09,

1998 1998 1998 1998

TABLET; ORAL PAROXETINE HYDROCHLORIDE ACTAVIS ELIZABETH EQ EQ EQ EQ ROXANE EQ EQ EQ EQ SANDOZ EQ EQ EQ EQ EQ TEVA PHARMS EQ EQ EQ PAXIL GLAXOSMITHKLINE EQ

10MG 20MG 30MG 40MG 10MG 20MG 30MG 40MG 10MG 20MG 30MG 40MG 10MG 20MG 30MG 40MG

BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE

A076968 A076968 A076968 A076968 A078026 A078026 A078026 A078026 A075566 A075566 A075566 A075566 A077082 A077082 A077082 A077082 N020031

001 002 003 004 001 002 003 004 001 002 003 004 001 002 003 004 004

Jun Jun Jun Jun Jun Jun Jun Jun Mar Mar Mar Mar Jun Jun Jun Jun

21, 21, 21, 21, 29, 29, 29, 29, 08, 08, 08, 08, 29, 29, 29, 29,

2010 2010 2010 2010 2007 2007 2007 2007 2004 2004 2004 2004 2007 2007 2007 2007

50MG BASE

Dec 29, 1992

PEMOLINE
TABLET; ORAL CYLERT ABBOTT

18.75MG

N016832

001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

PEMOLINE
TABLET; ORAL CYLERT ABBOTT PEMOLINE ACTAVIS TOTOWA

6 - 255 (of 346)

37.5MG 75MG 18.75MG 37.5MG 75MG 18.75MG 37.5MG 75MG 18.75MG 37.5MG 75MG 18.75MG 37.5MG 75MG 18.75MG 37.5MG 75MG 18.75MG 37.5MG 75MG

N016832 N016832 A075595 A075595 A075595 A075726 A075726 A075726 A075286 A075286 A075286 A075030 A075030 A075030 A075328 A075328 A075328 A075287 A075287 A075287

002 003 001 002 003 003 002 001 001 002 003 003 001 002 001 002 003 001 002 003 Feb Feb Feb Mar Mar Mar Dec Jun Jun Feb Jan Jan Apr Apr Apr Jun Sep Sep 28, 28, 28, 30, 30, 30, 27, 30, 30, 22, 29, 29, 19, 19, 19, 13, 18, 18, 2000 2000 2000 2001 2001 2001 1999 1999 1999 2000 1999 1999 2000 2000 2000 2001 2000 2000

MALLINCKRODT

SANDOZ

TEVA PHARMS

VINTAGE PHARMS

WATSON LABS

TABLET, CHEWABLE; ORAL CYLERT ABBOTT PEMOLINE ACTAVIS TOTOWA TEVA PHARMS

37.5MG 37.5MG 37.5MG

N017703 A075678 A075555

001 001 001 Jul 26, 2000 Feb 18, 2000

PENBUTOLOL SULFATE
TABLET; ORAL LEVATOL SCHWARZ PHARMA

10MG

N018976

001

Dec 30, 1987

PENICILLAMINE
CAPSULE; ORAL CUPRIMINE ATON

125MG

N019853

002

PENICILLIN G BENZATHINE
INJECTABLE; INJECTION BICILLIN L-A WYETH AYERST SUSPENSION; ORAL BICILLIN WYETH AYERST TABLET; ORAL BICILLIN WYETH AYERST

300,000 UNITS/ML

N050131

001

300,000 UNITS/5ML

N050126

002

200,000 UNITS

N050128

001

PENICILLIN G POTASSIUM
FOR SOLUTION; ORAL PENICILLIN TEVA PENICILLIN G POTASSIUM MYLAN

200,000 UNITS/5ML 400,000 UNITS/5ML 200,000 250,000 400,000 250,000 400,000 UNITS/5ML UNITS/5ML UNITS/5ML UNITS/5ML UNITS/5ML

A060307 A060307 A060752 A060752 A060752 A061740 A061740

002 004 003 002 001 001 002

PUREPAC PHARM

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

PENICILLIN G POTASSIUM
FOR SOLUTION; ORAL PENICILLIN-2 TEVA PENTIDS '200' APOTHECON PENTIDS '400' APOTHECON PFIZERPEN G PFIZER INJECTABLE; INJECTION PENICILLIN G POTASSIUM APOTHECON

6 - 256 (of 346)

250,000 UNITS/5ML 200,000 UNITS/5ML 400,000 UNITS/5ML 400,000 UNITS/5ML

A060307 A062149 A062149 A060587

003 001 002 001

CONSOLIDATED PHARM

LILLY

MARSAM PHARMS LLC

PARKE DAVIS PFIZER SANDOZ

PFIZERPEN
PFIZER
TABLET; ORAL PENICILLIN G POTASSIUM APOTHECON IVAX SUB TEVA PHARMS LILLY MYLAN

1,000,000 UNITS/VIAL 5,000,000 UNITS/VIAL 10,000,000 UNITS/VIAL 20,000,000 UNITS/VIAL 500,000 UNITS/VIAL 1,000,000 UNITS/VIAL 5,000,000 UNITS/VIAL 10,000,000 UNITS/VIAL 200,000 UNITS/VIAL 500,000 UNITS/VIAL 1,000,000 UNITS/VIAL 5,000,000 UNITS/VIAL 20,000,000 UNITS/VIAL 20,000,000 UNITS/VIAL 1,000,000 UNITS/VIAL 5,000,000 UNITS/VIAL 10,000,000 UNITS/VIAL 20,000,000 UNITS/VIAL 1,000,000 UNITS/VIAL 5,000,000 UNITS/VIAL 20,000,000 UNITS/VIAL 1,000,000 UNITS/VIAL 1,000,000 UNITS/VIAL

A060362 A060362 A060362 A060362 A060806 A060806 A060806 A060806 A060384 A060384 A060384 A060384 A060384 A060601 A062991 A062991 A062991 A062991 A062003 A062003 A060074 A065079 A060657

001 003 004 002 001 002 003 004 004 003 002 001 005 001 001 002 003 004 001 002 003 001 001

Sep Sep Sep Sep

13, 13, 13, 13,

1988 1988 1988 1988

Aug 30, 2002

PUREPAC PHARM

TEVA

WYETH AYERST

250,000 400,000 250,000 200,000 250,000 400,000 500,000 800,000 200,000 250,000 400,000 200,000 250,000 400,000 500,000 200,000 250,000 400,000

UNITS UNITS UNITS UNITS UNITS UNITS UNITS UNITS UNITS UNITS UNITS UNITS UNITS UNITS UNITS UNITS UNITS UNITS

A060392 A060073 A060403 A060781 A060781 A060781 A060781 A060781 A061588 A061588 A061588 A060306 A060306 A060306 A060306 A060413 A060413 A060413 A062155 A062155 A060392 A062155

003 004 001 001 002 003 005 004 001 002 003 001 002 003 004 001 002 003 001 002 004 003

PENTIDS '200'
APOTHECON
PENTIDS '250'
APOTHECON
PENTIDS '400'
APOTHECON

200,000 UNITS 250,000 UNITS 400,000 UNITS 400,000 UNITS

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

PENICILLIN G POTASSIUM
TABLET; ORAL PENTIDS '800' APOTHECON PFIZERPEN G PFIZER

6 - 257 (of 346)

800,000 UNITS 800,000 UNITS 50,000 UNITS 100,000 UNITS 200,000 UNITS 250,000 UNITS 400,000 UNITS 800,000 UNITS

A060392 A062155 A060075 A060075 A060075 A060075 A060075 A060075

005 004 001 002 003 004 005 006

PENICILLIN G PROCAINE
INJECTABLE; INJECTION DURACILLIN A.S. LILLY PENICILLIN G PROCAINE CONSOLIDATED PHARM PARKE DAVIS PFIZER PFIZERPEN-AS PFIZER

300,000 UNITS/ML 300,000 UNITS/ML 600,000 UNITS/1.2ML 300,000 UNITS/ML 300,000 UNITS/VIAL 1,500,000 UNITS/VIAL 300,000 UNITS/ML 600,000 UNITS/ML

A060093 A060800 A060800 A062029 A060099 A060099 A060286 A060286

001 001 002 001 001 002 001 002

PENICILLIN G SODIUM
INJECTABLE; IM-IV PENICILLIN G SODIUM MARSAM PHARMS LLC INJECTABLE; INJECTION PENICILLIN G SODIUM BRISTOL MYERS SQUIBB COPANOS PHARMACIA AND UPJOHN

5,000,000 UNITS/VIAL

A063014

001

Sep 13, 1988

5,000,000 UNITS/VIAL 5,000,000 UNITS/VIAL 1,000,000 UNITS/VIAL

A061935 A061051 A061046

001 001 001

PENICILLIN V
FOR SUSPENSION; ORAL V-CILLIN LILLY

125MG/0.6ML

A060002

001

PENICILLIN V POTASSIUM
FOR SOLUTION; ORAL BEEPEN-VK GLAXOSMITHKLINE BETAPEN-VK APOTHECON LEDERCILLIN VK LEDERLE PENAPAR-VK PARKE DAVIS PENICILLIN V POTASSIUM AM ANTIBIOTICS MYLAN PUREPAC PHARM

EQ 125MG BASE/5ML EQ 250MG BASE/5ML EQ 125MG BASE/5ML EQ 250MG BASE/5ML EQ 125MG BASE/5ML EQ 250MG BASE/5ML EQ 125MG BASE/5ML EQ 250MG BASE/5ML EQ EQ EQ EQ EQ EQ 125MG 250MG 125MG 250MG 125MG 250MG BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML BASE/5ML

A062270 A062270 A061149 A061149 A060136 A060136 A062002 A062002 A061529 A061529 A061624 A061624 A061758 A061758

001 002 001 002 001 002 001 002 001 002 002 001 001 002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

PENICILLIN V POTASSIUM
FOR SOLUTION; ORAL PEN-VEE K WYETH AYERST PFIZERPEN VK PFIZER V-CILLIN K LILLY VEETIDS APOTHECON VEETIDS '125' APOTHECON VEETIDS '250' APOTHECON TABLET; ORAL BEEPEN-VK GLAXOSMITHKLINE BETAPEN-VK BRISTOL LEDERCILLIN VK LEDERLE PENAPAR-VK PARKE DAVIS PENICILLIN V POTASSIUM AM ANTIBIOTICS IVAX SUB TEVA PHARMS

6 - 258 (of 346)

EQ 125MG BASE/5ML EQ 250MG BASE/5ML EQ 125MG BASE/5ML EQ 250MG BASE/5ML EQ 125MG BASE/5ML EQ 250MG BASE/5ML EQ 125MG BASE/5ML EQ 250MG BASE/5ML EQ 125MG BASE/5ML EQ 125MG BASE/5ML EQ 250MG BASE/5ML EQ 250MG BASE/5ML

A060007 A060007 A061815 A061815 A060004 A060004 A061410 A061410 A061206 A062153 A061206 A062153

001 002 001 002 001 002 001 002 001 001 002 002

EQ 250MG BASE EQ 500MG BASE EQ 250MG BASE EQ 500MG BASE EQ 250MG BASE EQ 500MG BASE EQ 250MG BASE EQ 500MG BASE EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ 250MG 500MG 125MG 250MG 500MG 250MG 500MG 125MG 250MG 500MG BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE

A062273 A062273 A061150 A061150 A060134 A060134 A062001 A062001 A061528 A061528 A060518 A060518 A060518 A061530 A061530 A061571 A061571 A061571 A060006 A060006 A060006 A061836 A061836 A061651 A061651 A060003 A060003 A060003 A061411 A061411 A061164

001 002 001 002 001 002 001 002 001 002 001 002 003 001 002 001 002 003 001 002 003 001 002 001 002 001 002 003 001 002 001

MYLAN PUREPAC PHARM

PEN-VEE K WYETH AYERST

EQ 125MG BASE EQ 250MG BASE EQ 500MG BASE EQ 250MG BASE EQ 500MG BASE EQ 250MG BASE EQ 500MG BASE EQ 125MG BASE EQ 250MG BASE EQ 500MG BASE EQ 250MG BASE EQ 500MG BASE EQ 250MG BASE

PFIZERPEN VK PFIZER UTICILLIN VK PHARMACIA AND UPJOHN V-CILLIN K LILLY

VEETIDS APOTHECON VEETIDS '250' APOTHECON

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

PENICILLIN V POTASSIUM
TABLET; ORAL VEETIDS '250' APOTHECON VEETIDS '500' APOTHECON

6 - 259 (of 346)

EQ 250MG BASE EQ 500MG BASE EQ 500MG BASE

A062156 A061164 A062156

002 002 001

PENTAGASTRIN
INJECTABLE; INJECTION PEPTAVLON WYETH AYERST

0.25MG/ML

N017048

001

PENTAMIDINE ISETHIONATE
FOR SOLUTION; INHALATION NEBUPENT APP PHARMS INJECTABLE; INJECTION PENTACARINAT ARMOUR PHARM PENTAMIDINE ISETHIONATE BAXTER HLTHCARE HOSPIRA

600MG/VIAL

N019887

002

Mar 22, 1996

300MG/VIAL 300MG/VIAL 300MG/VIAL

A073447 A073617 A073479

001 001 001

Apr 28, 1994 Dec 18, 1995 Jun 30, 1992

PENTAZOCINE HYDROCHLORIDE
TABLET; ORAL TALWIN 50 SANOFI AVENTIS US

EQ 50MG BASE

N016732

001

PENTETATE CALCIUM TRISODIUM

SOLUTION; INHALATION, INTRAVENOUS PENTETATE CALCIUM TRISODIUM HAMELN PHARMS EQ 1GM BASE/5ML (EQ 200MG BASE/ML)

N021749

001

Aug 11, 2004

PENTETATE CALCIUM TRISODIUM YB-169

INJECTABLE; INJECTION YTTERBIUM YB 169 DTPA 3M

2mCi/ML

N017518

001

PENTETATE ZINC TRISODIUM

SOLUTION; INHALATION, INTRAVENOUS PENTETATE ZINC TRISODIUM HAMELN PHARMS EQ 1GM BASE/5ML (EQ 200MG BASE/ML)

N021751

001

Aug 11, 2004

PENTOBARBITAL
ELIXIR; ORAL NEMBUTAL OVATION PHARMS

18.2MG/5ML

A083244

001

PENTOBARBITAL SODIUM
CAPSULE; ORAL NEMBUTAL SODIUM OVATION PHARMS

30MG 50MG 100MG 50MG 100MG 100MG 100MG 100MG 100MG

A084095 A084093 A083245 A085937 A085915 A083284 A083338 A084590 A083368

001 001 001 001 001 001 001 001 001

PENTOBARBITAL SODIUM LANNETT VITARINE WHITEWORTH TOWN PLSN SODIUM PENTOBARBITAL ANABOLIC ELKINS SINN

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

PENTOBARBITAL SODIUM
CAPSULE; ORAL SODIUM PENTOBARBITAL EVERYLIFE HALSEY IVAX SUB TEVA PHARMS PARKE DAVIS PERRIGO PUREPAC PHARM VALEANT PHARM INTL WATSON LABS WYETH AYERST INJECTABLE; INJECTION PENTOBARBITAL SODIUM ELKINS SINN SODIUM PENTOBARBITAL WYETH AYERST SUPPOSITORY; RECTAL NEMBUTAL OVATION PHARMS

6 - 260 (of 346)

100MG 100MG 50MG 100MG 100MG 100MG 100MG 100MG 100MG 100MG

A083259 A084677 A083461 A083461 A084156 A084560 A083301 A083264 A085791 A083239

001 001 001 002 001 001 001 001 001 001

50MG/ML 50MG/ML

A083270 A083261

001 001

30MG 60MG 120MG 200MG

A083247 A083247 A083247 A083247

001 002 003 004

Jan Jan Jan Jan

25, 25, 25, 25,

1982 1982 1982 1982

TABLET; ORAL PENTOBARBITAL SODIUM VITARINE SODIUM PENTOBARBITAL NEXGEN PHARMA INC

100MG 100MG

A083285 A084238

001 001

PENTOLINIUM TARTRATE
INJECTABLE; INJECTION ANSOLYSEN WYETH AYERST

10MG/ML

N009372

001

PENTOXIFYLLINE
TABLET, EXTENDED RELEASE; PENTOXIFYLLINE ACTAVIS ELIZABETH HERITAGE PHARMS INC TEVA ORAL 400MG 400MG 400MG A074878 A074877 A075199 001 001 001 Jul 09, 1997 Jul 08, 1997 Sep 03, 1999

PERFLUBRON
LIQUID; ORAL IMAGENT ALLIANCE PHARM

100%

N020091

001

Aug 13, 1993

PERFLUOROPOLYMETHYLISOPROPYL ETHER; POLYTETRAFLUOROETHYLENE

PASTE; TOPICAL SKIN EXPOSURE REDUCTION PASTE AGAINST CHEMICAL WARFARE AGENTS US ARMY 50%;50%

N021084

001

Feb 17, 2000

PERGOLIDE MESYLATE
TABLET; ORAL PERGOLIDE MESYLATE IVAX SUB TEVA PHARMS

PAR PHARM

EQ EQ EQ EQ EQ EQ

0.05MG BASE 0.25MG BASE 1MG BASE 0.05MG BASE 0.25MG BASE 1MG BASE

A076094 A076094 A076094 A076061 A076061 A076061 N019385

001 002 003 001 002 003 001

Sep Sep Sep Nov Nov Nov

04, 04, 04, 27, 27, 27,

2003 2003 2003 2002 2002 2002

PERMAX VALEANT PHARM INTL

EQ 0.05MG BASE

Dec 30, 1988

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

PERGOLIDE MESYLATE
TABLET; ORAL PERMAX VALEANT PHARM INTL

6 - 261 (of 346)

EQ 0.25MG BASE EQ 1MG BASE

N019385 N019385

002 003

Dec 30, 1988 Dec 30, 1988

PERMETHRIN
LOTION; TOPICAL NIX GLAXOSMITHKLINE

1%

N019435

001

Mar 31, 1986

PERPHENAZINE
CONCENTRATE; ORAL PERPHENAZINE PHARM ASSOC TRILAFON SCHERING INJECTABLE; INJECTION TRILAFON SCHERING SYRUP; ORAL TRILAFON SCHERING TABLET; ORAL PERPHENAZINE IVAX PHARMS

16MG/5ML 16MG/5ML

A040360 N011557

001 001

May 25, 2001

5MG/ML

N011213

002

2MG/5ML

N011294

002

2MG 4MG 8MG 16MG

A089707 A089708 A089456 A089457 N010775 N010775 N010775 N010775

001 001 001 001 001 002 003 004

Sep Sep Sep Sep

10, 10, 10, 10,

1987 1987 1987 1987

2MG 4MG 8MG 16MG TABLET, EXTENDED RELEASE; ORAL TRILAFON SCHERING 8MG

TRILAFON SCHERING

N011361

002

PHENACEMIDE
TABLET; ORAL PHENURONE ABBOTT

500MG

N007707

001

PHENAZOPYRIDINE HYDROCHLORIDE; SULFAMETHOXAZOLE

TABLET; ORAL AZO GANTANOL ROCHE

100MG;500MG

N013294

001

Sep 10, 1987

PHENAZOPYRIDINE HYDROCHLORIDE; SULFAMETHOXAZOLE; TRIMETHOPRIM

TABLET; ORAL SULFAMETHOXAZOLE AND TRIMETHOPRIM AND PENAZOPYRIDINE HYDROCHLORIDE ABLE 200MG,N/A,N/A;N/A,800MG,160MG N021105

001

Jun 26, 2001

PHENAZOPYRIDINE HYDROCHLORIDE; SULFISOXAZOLE

TABLET; ORAL AZO GANTRISIN ROCHE

50MG;500MG

N019358

001

Aug 31, 1990

PHENDIMETRAZINE TARTRATE
CAPSULE; ORAL PHENAZINE MAST MM

35MG 35MG

A086523 A086524

001 001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

PHENDIMETRAZINE TARTRATE
CAPSULE; ORAL PHENAZINE MAST MM 35MG PHENDIMETRAZINE TARTRATE SANDOZ 35MG 35MG 35MG 35MG VITARINE 35MG 35MG 35MG 35MG 35MG 35MG 35MG SPRX-3 SOLVAY 35MG STATOBEX TEVA 35MG X-TROZINE SHIRE RICHWOOD 35MG CAPSULE, EXTENDED RELEASE; ORAL MELFIAT-105 NUMARK 105MG PHENDIMETRAZINE TARTRATE GRAHAM DM 105MG 105MG 105MG 105MG 105MG 105MG SANDOZ 105MG SPRX-105 NUMARK 105MG X-TROZINE L.A. SHIRE RICHWOOD 105MG TABLET; ORAL ADPHEN FERNDALE LABS 35MG ALPHAZINE SANDOZ 35MG CAM-METRAZINE ABC HOLDING 35MG CAMALL 35MG TG UNITED LABS 35MG 35MG 35MG 35MG DI-METREX PVT FORM 35MG MELFIAT NUMARK 35MG METRA FOREST PHARMS 35MG PHENAZINE MAST MM 35MG PHENAZINE-35 ABC HOLDING 35MG PHENDIMETRAZINE TARTRATE BARR 35MG 35MG 35MG 35MG

6 - 262 (of 346)

A086525 A085633 A085694 A085695 A085702 A085634 A085645 A085670 A086403 A086408 A086410 A087424 A085897 A085507 A087394

001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 Sep 22, 1982

A087487 A087214 A088020 A088028 A088062 A088063 A088111 A087378 A088024 A087371

001 001 001 001 001 001 001 001 001 001

Oct 13, 1982 May Aug Aug Sep Sep Oct 26, 16, 16, 13, 10, 18, 1982 1982 1982 1982 1982 1982

Dec 22, 1982 Aug 24, 1982

A083655 A085034 A085511 A085756 A083922 A085318 A085320 A085321 A085698 A083790 A083754 A087305 A085512 A083644 A083684 A083686 A083687

001 001 001 001 001 001 001 001 001 002 001 001 001 001 001 001 001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

PHENDIMETRAZINE TARTRATE
TABLET; ORAL PHENDIMETRAZINE TARTRATE BARR 35MG 35MG 35MG FERNDALE LABS 35MG INWOOD LABS 35MG 35MG 35MG 35MG IVAX PHARMS 35MG 35MG IVAX SUB TEVA PHARMS 35MG KV PHARM 35MG 35MG 35MG MFG CHEMISTS 35MG NEXGEN PHARMA INC 35MG NUMARK 35MG PVT FORM 35MG 35MG SANDOZ 35MG 35MG 35MG 35MG 35MG SOLVAY 35MG TG UNITED LABS 35MG 35MG USL PHARMA 35MG 35MG 35MG VITARINE 35MG 35MG 35MG WATSON LABS 35MG 35MG 35MG 35MG PLEGINE
WYETH AYERST
35MG STATOBEX
TEVA
35MG STATOBEX-G
TEVA
35MG X-TROZINE
SHIRE RICHWOOD 35MG 35MG 35MG 35MG 35MG

6 - 263 (of 346)

A084831 A084834 A084835 A086834 A084740 A084741 A084742 A084743 A085611 A085612 A083682 A084138 A084141 A085525 A085914 A086020 A083790 A085199 A085697 A085402 A085497 A085830 A086365 A086370 A083993 A085761 A085941 A083805 A084398 A084399 A085519 A086005 A086106 A085767 A085768 A085770 A085773 N012248 A086013 A085095 A086550 A086551 A086552 A086553 A086554

001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001

Sep 15, 1983

Jun 27, 1983

PHENINDIONE
TABLET; ORAL HEDULIN SANOFI AVENTIS US

50MG

N008767

002

PHENMETRAZINE HYDROCHLORIDE
TABLET; ORAL PRELUDIN BOEHRINGER INGELHEIM

25MG

N010460

005

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

PHENMETRAZINE HYDROCHLORIDE
TABLET, EXTENDED RELEASE; ORAL PRELUDIN BOEHRINGER INGELHEIM 50MG 75MG

6 - 264 (of 346)

N011752 N011752

004 003

PHENPROCOUMON
TABLET; ORAL LIQUAMAR ORGANON USA INC

3MG

N011228

001

PHENSUXIMIDE
CAPSULE; ORAL MILONTIN PARKE DAVIS

500MG

N008855

004

PHENTERMINE HYDROCHLORIDE
CAPSULE; ORAL FASTIN GLAXOSMITHKLINE OBESTIN-30 FERNDALE LABS OBY-TRIM SHIRE RICHWOOD ONA-MAST MAST MM

30MG 30MG 30MG

N017352 A087144 A087764 A086511 A086516 A085411 A040497 A040403 A040427 A040460 A040227 A040448 A040228 A086735 A087226 A088948 A086329 A040527 A087208 A087223 A088414 A086911 A087126 A087777 A088612 A088613 A088614 A040083 A088576 A085417 A086732 A087215 A087915 A087918 A087930 A088610 A088611 A088625 A084487 A088430

001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 002 001 001 001 001 001 001 001 001 001 Mar 18, 1982

30MG 30MG PHENTERMINE HYDROCHLORIDE ABC HOLDING 30MG ABLE 15MG 30MG 30MG ACTAVIS TOTOWA 15MG 30MG 30MG 37.5MG CAMALL 15MG 30MG DURAMED PHARMS BARR 30MG IVAX PHARMS 30MG MUTUAL PHARM 37.5MG SANDOZ 30MG 30MG 37.5MG TEVA 30MG 30MG 30MG 30MG 30MG 30MG TG UNITED INC 30MG TG UNITED LABS 18.75MG 30MG 30MG 30MG 37.5MG 37.5MG 37.5MG 37.5MG 37.5MG 37.5MG USL PHARMA 30MG 30MG

Mar Aug Aug Jan Jun Jan Jun

13, 30, 30, 14, 18, 22, 19,

2003 2001 2001 2003 1997 2003 1997

Apr 25, 1986 Oct 23, 2003

Oct 19, 1983

Nov Apr Apr Apr Mar May

01, 04, 09, 09, 07, 23,

1985 1984 1984 1984 1997 1984

Dec Dec Oct Jun Jun Aug Apr Mar

22, 22, 14, 04, 04, 23, 09, 27,

1983 1983 1983 1984 1984 1984 1982 1984

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

PHENTERMINE HYDROCHLORIDE
CAPSULE; ORAL PHENTERMINE HYDROCHLORIDE USL PHARMA 30MG VITARINE 30MG 30MG WATSON LABS 30MG TABLET; ORAL ONA-MAST MAST MM 8MG PHENTERMINE HYDROCHLORIDE ABLE 37.5MG ACTAVIS TOTOWA 37.5MG IVAX PHARMS 8MG SANDOZ 8MG 8MG TG UNITED LABS 8MG 8MG 37.5MG 37.5MG USL PHARMA 8MG 37.5MG 37.5MG VITARINE 8MG 8MG WATSON LABS 8MG TORA SOLVAY 8MG WILPO SANDOZ 8MG

6 - 265 (of 346)

A088797 A087202 A087235 A086740

001 001 001 001

Dec 10, 1984

Mar 21, 1985

A086260 A040402 A040190 A085553 A085671 A085689 A083923 A085319 A087805 A088596 A083804 A088910 A088917 A086453 A086456 A085739 A084035 N012737

001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 Aug 30, 2001 May 30, 1997

Dec 06, 1982 Apr 04, 1984 Jul 17, 1985 Jul 17, 1985

PHENTERMINE RESIN COMPLEX

CAPSULE, EXTENDED RELEASE; ORAL IONAMIN UCB INC EQ 15MG BASE EQ 30MG BASE PHENTERMINE RESIN 30 QUANTUM PHARMICS EQ 30MG BASE

N011613 N011613 A089120

004 002 001 Feb 04, 1988

PHENYL AMINOSALICYLATE
POWDER; ORAL PHENY-PAS-TEBAMIN PHARM RES ASSOC TABLET; ORAL PHENY-PAS-TEBAMIN PHARM RES ASSOC

50%

N011695

002

500MG

N011695

003

PHENYLBUTAZONE
CAPSULE; ORAL AZOLID SANOFI AVENTIS US BUTAZOLIDIN NOVARTIS PHENYLBUTAZONE IVAX PHARMS MUTUAL PHARM SANDOZ WATSON LABS TABLET; ORAL AZOLID SANOFI AVENTIS US BUTAZOLIDIN NOVARTIS

100MG 100MG 100MG 100MG 100MG 100MG

A087260 N008319 A088218 A088994 A087774 A087756

001 009 001 001 001 001 Jun Dec Jun Dec 24, 04, 16, 17, 1983 1985 1982 1982

100MG 100MG

A087091 N008319

001 008

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

PHENYLBUTAZONE
TABLET; ORAL PHENYLBUTAZONE MUTUAL PHARM SANDOZ WATSON LABS

6 - 266 (of 346)

100MG 100MG 100MG 100MG

A088863 A084339 A086151 A087674

001 001 001 001

Dec 04, 1985

Apr 21, 1982

PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE

SYRUP; ORAL PHENERGAN VC ANI PHARMS PHERAZINE VC HALSEY PROMETHAZINE VC PLAIN CENCI WOCKHARDT

5MG/5ML;6.25MG/5ML 5MG/5ML;6.25MG/5ML 5MG/5ML;6.25MG/5ML 5MG/5ML;6.25MG/5ML

N008604 A088868 A088815 A088897

003 001 001 001

Apr 02, 1984 Mar 02, 1987 Nov 22, 1985 Jan 04, 1985

PHENYLEPHRINE HYDROCHLORIDE; PYRILAMINE MALEATE

SOLUTION/DROPS; OPHTHALMIC PREFRIN-A ALLERGAN 0.12%;0.1%

N007953

001

PHENYTOIN
SUSPENSION; ORAL DILANTIN-30 PARKE DAVIS PHENYTOIN ACTAVIS MID ATLANTIC

30MG/5ML 125MG/5ML

N008762 A089892

002 001 Sep 25, 1992

PHENYTOIN SODIUM
CAPSULE; ORAL DIPHENYLAN SODIUM LANNETT

30MG PROMPT 100MG PROMPT EXTENDED PHENYTOIN SODIUM BARR 100MG EXTENDED PLIVA 100MG EXTENDED PHENYTEX WATSON LABS 100MG EXTENDED PHENYTOIN SODIUM PHARMERAL 100MG PROMPT WATSON LABS 100MG PROMPT PROMPT PHENYTOIN SODIUM IVAX SUB TEVA PHARMS 100MG PROMPT WATSON LABS 100MG PROMPT INJECTABLE; INJECTION DILANTIN PARKE DAVIS 50MG/ML PHENYTOIN SODIUM APP PHARMS 50MG/ML MARSAM PHARMS LLC 50MG/ML 50MG/ML SMITH AND NEPHEW 50MG/ML 50MG/ML SOLOPAK 50MG/ML WARNER CHILCOTT 50MG/ML WATSON LABS 50MG/ML

A080857 A080857 A040435 A089441 A088711 A085435 A085894 A080259 A080905

001 002 001 001 001 001 001 001 001 Jun 20, 2003 Dec 18, 1986 Dec 21, 1984

N010151 A089003 A089501 A089779 A088519 A088521 A088520 A089900 A085434

001 001 001 001 001 001 001 001 001 May Oct Nov Dec Dec Dec Mar 31, 13, 27, 19, 18, 17, 30, 1985 1987 1992 1984 1984 1984 1990

PHYTONADIONE
INJECTABLE; INJECTION AQUAMEPHYTON BIOVAIL TECHNOLOGIES

1MG/0.5ML

N012223

002

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DISCONTINUED DRUG PRODUCT LIST

PHYTONADIONE
INJECTABLE; INJECTION AQUAMEPHYTON BIOVAIL TECHNOLOGIES KONAKION ROCHE PHYTONADIONE GLAXOSMITHKLINE VITAMIN K1 HOSPIRA

6 - 267 (of 346)

10MG/ML 1MG/0.5ML 10MG/ML 1MG/0.5ML 10MG/ML 10MG/ML

N012223 N011745 N011745 A084060 A084060 A087956

001 001 003 001 002 001 Jul 25, 1983

PILOCARPINE
INSERT, EXTENDED RELEASE; OPHTHALMIC OCUSERT PILO-20 AKORN 5MG OCUSERT PILO-40 AKORN 11MG

N017431 N017548

001 001

PINACIDIL
CAPSULE, EXTENDED RELEASE; ORAL PINDAC LEO PHARM 12.5MG 25MG

N019456 N019456

001 002

Dec 28, 1989 Dec 28, 1989

PINDOLOL
TABLET; ORAL PINDOLOL GENPHARM IVAX SUB TEVA PHARMS MUTUAL PHARM NOSTRUM LABS PUREPAC PHARM SANDOZ TEVA

5MG 10MG 5MG 10MG 5MG 10MG 5MG 10MG 5MG 10MG 5MG 10MG 5MG 5MG 10MG 10MG 5MG 10MG

A074013 A074018 A073687 A073687 A074063 A074063 A074474 A074474 A074125 A074125 A073608 A073609 A073661 A074123 A073661 A074123 N018285 N018285

001 001 001 002 001 002 001 002 001 002 001 001 001 001 002 002 001 002

Sep Sep Feb Feb Jan Jan Oct Oct Apr Apr Mar Mar Oct Apr Oct Apr

24, 24, 26, 26, 27, 27, 28, 28, 28, 28, 29, 29, 31, 17, 31, 17,

1992 1992 1993 1993 1994 1994 1996 1996 1993 1993 1993 1993 1993 1997 1993 1997

VISKEN NOVARTIS

Sep 03, 1982 Sep 03, 1982

PIPECURONIUM BROMIDE
INJECTABLE; INJECTION ARDUAN ORGANON USA INC

10MG/VIAL

N019638

001

Jun 26, 1990

PIPERACETAZINE
TABLET; ORAL QUIDE DOW PHARM

10MG 25MG

N013615 N013615

001 002

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DISCONTINUED DRUG PRODUCT LIST

PIPERACILLIN SODIUM
INJECTABLE; INJECTION PIPRACIL WYETH PHARMS INC

6 - 268 (of 346)

EQ EQ EQ EQ EQ EQ EQ

2GM BASE/VIAL 2GM BASE/VIAL 3GM BASE/VIAL 3GM BASE/VIAL 4GM BASE/VIAL 4GM BASE/VIAL 40GM BASE/VIAL

A062750 N050545 A062750 N050545 A062750 N050545 N050545

001 002 002 003 003 004 006

Oct 13, 1987 Oct 13, 1987 Oct 13, 1987 Sep 30, 1985

PIPERAZINE CITRATE
SYRUP; ORAL ANTEPAR GLAXOSMITHKLINE BRYREL SANOFI AVENTIS US MULTIFUGE BLULINE PIPERAZINE CITRATE ALPHARMA US PHARMS LANNETT LUITPOLD VERMIDOL SOLVAY TABLET; ORAL ANTEPAR GLAXOSMITHKLINE PIPERAZINE CITRATE IMPAX LABS

EQ 500MG BASE/5ML EQ 500MG BASE/5ML EQ 500MG BASE/5ML EQ 500MG BASE/5ML EQ 500MG BASE/5ML EQ 500MG BASE/5ML EQ 500MG BASE/5ML

N009102 N017796 N009452 A080774 A080963 A080671 A080992

001 001 001 001 001 001 001

EQ 500MG BASE EQ 250MG BASE

N009102 A080874

003 001

PIPOBROMAN
TABLET; ORAL VERCYTE ABBOTT

10MG 25MG

N016245 N016245

001 002

PIRBUTEROL ACETATE
AEROSOL, METERED; INHALATION MAXAIR EQ 0.2MG BASE/INH MEDICIS

N019009

001

Dec 30, 1986

PIROXICAM
CAPSULE; ORAL
PIROXICAM
EGIS
IVAX SUB TEVA PHARMS MUTUAL PHARM MYLAN ROXANE SCS TEVA TEVA PHARMS

10MG 20MG 10MG 20MG 20MG 10MG 20MG 10MG 20MG 10MG 20MG 10MG 20MG 10MG 20MG

A074808 A074808 A074148 A074148 A073536 A074043 A074043 A073651 A073651 A074036 A074036 A073637 A073638 A074103 A074103

001 002 001 002 001 001 002 001 002 001 002 001 001 001 002

Jul Jul Jun Jun Mar Sep Sep Feb Feb May May Jan Jan Aug Aug

08, 08, 03, 03, 12, 22, 22, 26, 26, 29, 29, 28, 28, 28, 28,

1997 1997 1996 1996 1993 1992 1992 1993 1993 1992 1992 1994 1994 1992 1992

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

PLICAMYCIN
INJECTABLE; INJECTION

MITHRACIN

PFIZER

6 - 269 (of 346)

2.5MG/VIAL

N050109

001

POLYESTRADIOL PHOSPHATE

INJECTABLE; INJECTION

ESTRADURIN
WYETH AYERST

40MG/AMP

N010753

001

POLYETHYLENE GLYCOL 3350

FOR SOLUTION; ORAL POLYETHYLENE GLYCOL 3350 TEVA PHARMS 17GM/SCOOPFUL

A077445

001

May 04, 2006

POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE
SOLUTION; ORAL OCL HOSPIRA

6GM/100ML;75MG/100ML;168MG/100ML;146MG/ N019284 100ML;1.29GM/100ML

001

Apr 30, 1986

POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS
FOR SOLUTION; ORAL COLYTE MEDA PHARMS

120GM/PACKET;1.49GM/PACKET;3.36GM/PACKE N018983 T;2.92GM/PACKET;11.36GM/PACKET 227.1GM/PACKET;2.82GM/PACKET;6.36GM/PAC N018983 KET;5.53GM/PACKET;21.5GM/PACKET 360GM/PACKET;4.47GM/PACKET;10.08GM/PACK N018983 ET;8.76GM/PACKET;34.08GM/PACKET

005 004 006

Oct 26, 1984 Oct 26, 1984 Oct 26, 1984

FOR SUSPENSION; ORAL CO-LAV BOCA PHARMA COLOVAGE DYNAPHARM E-Z-EM PREP LYTE E Z EM GLYCOPREP GOLDLINE GO-EVAC BOCA PHARMA PEG-LYTE SANDOZ

240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/ A073428 BOT;22.72GM/BOT 227.1GM/PACKET;2.82GM/PACKET;6.36GM/PAC A071320 KET;5.53GM/PACKET;21.5GM/PACKET 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/ A071278 BOT;22.74GM/BOT 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/ A072319 BOT;22.74GM/BOT 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/ A073433 BOT;22.74GM/BOT 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/ A073098 BOT;22.74GM/BOT

001

Jan 28, 1992

001

Apr 20, 1988

001

Nov 21, 1988

001

Dec 23, 1988

001

Apr 28, 1992

001

Aug 31, 1993

POLYMYXIN B SULFATE
INJECTABLE; INJECTION AEROSPORIN GLAXOSMITHKLINE EQ 500,000 U BASE/VIAL POWDER; FOR RX COMPOUNDING POLYMYXIN B SULFATE PADDOCK LLC 100,000,000 UNITS/BOT

A062036

001

A062455

001

Jul 27, 1983

POLYTHIAZIDE
TABLET; ORAL

RENESE

PFIZER

1MG 2MG 4MG

N012845 N012845 N012845

001

002

003

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

POLYTHIAZIDE; PRAZOSIN HYDROCHLORIDE
CAPSULE; ORAL MINIZIDE PFIZER

6 - 270 (of 346)

0.5MG;EQ 1MG BASE 0.5MG;EQ 2MG BASE 0.5MG;EQ 5MG BASE

N017986 N017986 N017986

001 002 003

POLYTHIAZIDE; RESERPINE
TABLET; ORAL RENESE-R PFIZER

2MG;0.25MG

N013636

001

POTASSIUM AMINOSALICYLATE
CAPSULE; ORAL PASKALIUM GLENWOOD 500MG POWDER; ORAL POTASSIUM AMINOSALICYLATE HEXCEL 100% TABLET; ORAL PASKALIUM GLENWOOD 1GM

N009395

004

A080098

001

N009395

003

POTASSIUM CHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL K-LEASE SAVAGE LABS 8MEQ 10MEQ POTASSIUM CHLORIDE NESHER PHARMS 10MEQ TEVA 8MEQ 10MEQ FOR SUSPENSION, EXTENDED RELEASE; ORAL MICRO-K LS KV PHARM 20MEQ/PACKET INJECTABLE; INJECTION POTASSIUM CHLORIDE ABRAXIS PHARM 2MEQ/ML 2MEQ/ML 2MEQ/ML 2MEQ/ML 2MEQ/ML 2MEQ/ML AKORN 2MEQ/ML APP PHARMS 2MEQ/ML BAXTER HLTHCARE 2MEQ/ML GD SEARLE LLC 1MEQ/ML 2MEQ/ML 2MEQ/ML 3MEQ/ML 3MEQ/ML 4MEQ/ML HOSPIRA 1MEQ/ML 1MEQ/ML 1.5MEQ/ML 2MEQ/ML 2.4MEQ/ML 3.2MEQ/ML LILLY 2MEQ/ML LUITPOLD 2MEQ/ML 2MEQ/ML 2MEQ/ML 2MEQ/ML MILES 1MEQ/ML

A073398 A072427 A070980 A073531 A073532

001 001 001 001 001

Jan 28, 1992 Mar 28, 1990 Feb 17, 1987 Apr 26, 1996 Apr 26, 1996

N019561

003

Aug 26, 1988

A080204 A084290 A086713 A086714 A087787 A087885 A088286 A087817 A080203 A086219 A086219 A086220 A086219 A086220 A086219 A080205 A083345 A083345 A083345 A080205 A080205 N007865 A080221 A080736 A087584 A087585 A080195

001 001 001 001 001 001 001 001 001 001 002 002 003 001 004 003 003 001 002 004 005 002 001 001 001 001 002

Apr Feb Sep Oct

20, 03, 05, 20,

1982 1983 1985 1982

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

POTASSIUM CHLORIDE
INJECTABLE; INJECTION POTASSIUM CHLORIDE MILES

6 - 271 (of 346)

2MEQ/ML 3MEQ/ML 4MEQ/ML PHARMA SERVE NY 2MEQ/ML 2MEQ/ML WATSON LABS 2MEQ/ML 2MEQ/ML 2MEQ/ML 3MEQ/ML TABLET, EXTENDED RELEASE; ORAL K+8 FUTURE PAK 8MEQ KAON CL SAVAGE LABS 6.7MEQ POTASSIUM CHLORIDE COPLEY PHARM 8MEQ SLOW-K NOVARTIS 8MEQ TEN-K NOVARTIS 10MEQ

A080195 A080195 A080195 A086297 A087362 A086208 A089163 A089421 A086210

001 003 004 001 001 001 001 001 001

Mar 08, 1983 Mar 10, 1988 Jan 02, 1987

A070998 N017046 A070618 N017476 N019381

001 001 001 002 001

Jan 25, 1993

Sep 09, 1987

Apr 16, 1986

POTASSIUM CHLORIDE; SODIUM CHLORIDE

INJECTABLE; INJECTION POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER B BRAUN 37MG/100ML;900MG/100ML N019708 POTASSIUM CHLORIDE 0.075% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER B BRAUN 75MG/100ML;900MG/100ML N019708 POTASSIUM CHLORIDE 0.11% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER B BRAUN 110MG/100ML;900MG/100ML N019708 POTASSIUM CHLORIDE 0.22% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER B BRAUN 220MG/100ML;900MG/100ML N019708 POTASSIUM CHLORIDE 0.3% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER B BRAUN 300MG/100ML;900MG/100ML N019708 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER B BRAUN 75MG/100ML;900MG/100ML N018722 BAXTER HLTHCARE 75MG/100ML;900MG/100ML N017648 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER B BRAUN 150MG/100ML;900MG/100ML N018722 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER B BRAUN 220MG/100ML;900MG/100ML N018722 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER B BRAUN 300MG/100ML;900MG/100ML N018722

001 002 003 005 006 001 004 002 003 004

Sep 29, 1989 Sep 29, 1989 Sep 29, 1989 Sep 29, 1989 Sep 29, 1989 Nov 09, 1982

Nov 09, 1982 Nov 09, 1982 Nov 09, 1982

POTASSIUM CHLORIDE; SODIUM CHLORIDE; TROMETHAMINE

INJECTABLE; INJECTION THAM-E HOSPIRA

370MG/VIAL;1.75GM/VIAL;36GM/VIAL

N013025

001

POTASSIUM CITRATE
FOR SOLUTION; ORAL POTASSIUM CITRATE UNIV TX SW MEDCTR

10MEQ/PACKET 20MEQ/PACKET

N019647 N019647

002 001

Oct 13, 1988 Oct 13, 1988

POTASSIUM IODIDE
SOLUTION; ORAL POTASSIUM IODIDE ROXANE

1GM/ML

N018551

001

Feb 19, 1982

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DISCONTINUED DRUG PRODUCT LIST

POTASSIUM IODIDE
TABLET; ORAL THYRO-BLOCK MEDPOINTE PHARM HLC

6 - 272 (of 346)

130MG

N018307

001

POTASSIUM PERCHLORATE
CAPSULE; ORAL PERCHLORACAP MALLINCKRODT

200MG

N017551

001

POVIDONE-IODINE
SOLUTION; TOPICAL E-Z PREP CLINIPAD SPONGE; TOPICAL E-Z PREP CLINIPAD E-Z PREP 220 CLINIPAD

10%

N019382

001

Jul 25, 1989

5% 5%

N019382 N019382

002 003

Jul 25, 1989 Jul 25, 1989

PRALIDOXIME CHLORIDE
INJECTABLE; INJECTION PRALIDOXIME CHLORIDE BAXTER HLTHCARE CORP TABLET; ORAL PROTOPAM CHLORIDE WYETH AYERST

300MG/ML

N018799

001

Dec 13, 1982

500MG

N014122

002

PRAMIPEXOLE DIHYDROCHLORIDE
TABLET; ORAL MIRAPEX BOEHRINGER INGELHEIM

1.25MG

N020667

004

Jul 01, 1997

PRAZEPAM
CAPSULE; ORAL CENTRAX PARKE DAVIS

5MG 10MG 20MG 5MG 10MG

N018144 N018144 N018144 A070427 A070428

001 002 003 001 001

May 10, 1982 Nov 06, 1987 Nov 06, 1987

PRAZEPAM USL PHARMA TABLET; ORAL CENTRAX PARKE DAVIS

10MG

N017415

001

PRAZOSIN HYDROCHLORIDE
CAPSULE; ORAL PRAZOSIN HYDROCHLORIDE AM THERAP

CLONMEL HLTHCARE

PUREPAC PHARM

SANDOZ

WATSON LABS

EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ

1MG 2MG 5MG 1MG 2MG 5MG 1MG 2MG 5MG 1MG 2MG 5MG 1MG 2MG

BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE

A072782 A072783 A072784 A072705 A072706 A072707 A072991 A072921 A072992 A072576 A072577 A072578 A072352 A072333

001 001 001 001 001 001 001 001 001 001 001 001 001 001

May May May May May May May May May May May May May May

16, 16, 16, 16, 16, 16, 16, 16, 16, 16, 16, 16, 16, 16,

1989 1989 1989 1989 1989 1989 1989 1989 1989 1989 1989 1989 1989 1989

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

PRAZOSIN HYDROCHLORIDE
CAPSULE; ORAL PRAZOSIN HYDROCHLORIDE WATSON LABS EQ 5MG BASE TABLET, EXTENDED RELEASE; ORAL MINIPRESS XL PFIZER 2.5MG 5MG

6 - 273 (of 346)

A072609

001

May 16, 1989

N019775 N019775

001 002

Jan 29, 1992 Jan 29, 1992

PREDNISOLONE
CREAM; TOPICAL METI-DERM SCHERING SYRUP; ORAL PREDNISOLONE IVAX SUB TEVA PHARMS TEVA PHARMS WE PHARMS PRELONE MURO TABLET; ORAL CORTALONE HALSEY

0.5%

N010209

002

15MG/5ML 15MG/5ML 15MG/5ML 5MG/5ML

A040287 A040322 A040192 A089654

001 001 001 001

May 28, 1999 Jan 19, 2000 May 28, 1998 Jan 17, 1989

1MG 2.5MG 5MG 5MG 5MG 5MG 5MG 5MG 1MG 2.5MG 5MG 2.5MG 5MG 5MG 5MG 5MG 5MG 5MG 5MG 1MG 5MG 5MG 5MG 5MG 5MG 5MG 5MG 5MG 1MG 2.5MG 5MG 5MG 5MG 5MG 5MG 5MG 5MG 5MG 5MG

A080304 A080304 A080304 N009987 A083941 A084426 A083675 A080625 A084439 A084439 A084439 A080562 A080562 A080326 A080780 A080748 A080378 A080531 A080307 A080351 A080351 A084542 A080322 A080325 A080211 A080327 A080339 A084773 A080358 A080358 A080358 A088892 A085170 A080398 A087987 A080236 A080534 A085085 A085415

003 002 001 004 001 002 001 001 001 002 003 001 002 001 001 001 001 002 001 001 002 001 001 001 001 002 001 001 001 002 003 001 001 001 001 001 001 002 001

DELTA-CORTEF PHARMACIA AND UPJOHN FERNISOLONE-P FERNDALE LABS PREDNISOLONE BARR BUNDY ELKINS SINN EVERYLIFE

FERRANTE HEATHER IMPAX LABS INWOOD LABS IVAX SUB TEVA PHARMS LANNETT MARSHALL PHARMA PANRAY PERRIGO PHOENIX LABS NY PUREPAC PHARM PVT FORM ROXANE SANDOZ SPERTI

SUPERPHARM TABLICAPS TEVA UDL VALEANT PHARM INTL VITARINE WATSON LABS

Feb 26, 1985

Jan 18, 1983

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

PREDNISOLONE
TABLET; ORAL PREDNISOLONE WATSON LABS WEST WARD WHITEWORTH TOWN PLSN STERANE PFIZER

6 - 274 (of 346)

5MG 5MG 5MG 5MG

A085416 A080324 A080342 N009996

001 001 001 001

PREDNISOLONE ACETATE
INJECTABLE; INJECTION METICORTELONE SCHERING PREDNISOLONE ACETATE AKORN BEL MAR CENT PHARMS WATSON LABS

25MG/ML 25MG/ML 50MG/ML 25MG/ML 50MG/ML 25MG/ML 50MG/ML 25MG/ML 25MG/ML 40MG/ML 50MG/ML 50MG/ML

N010255 A083032 A084492 A083738 A083738 A084717 A084717 A083398 A083654 A083767 A083764 A085781 N011446

002 001 001 001 002 001 002 001 001 001 001 001 001

STERANE PFIZER 25MG/ML SUSPENSION; ORAL FLO-PRED TARO EQ 5MG BASE/5ML SUSPENSION/DROPS; OPHTHALMIC ECONOPRED ALCON 0.125%

N022067

001

Jan 17, 2008

N017468

001

PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM

OINTMENT; OPHTHALMIC CETAPRED ALCON 0.25%;10% METIMYD SCHERING 0.5%;10% PREDSULFAIR PHARMAFAIR 0.5%;10% VASOCIDIN NOVARTIS 0.5%;10% SUSPENSION; OPHTHALMIC ISOPTO CETAPRED ALCON 0.25%;10% SUSPENSION/DROPS; OPHTHALMIC METIMYD SCHERING 0.5%;10% PREDAMIDE AKORN 0.5%;10% PREDSULFAIR PHARMAFAIR 0.5%;10% PREDSULFAIR II PHARMAFAIR 0.2%;10% SULPHRIN BAUSCH AND LOMB 0.5%;10%

A087771 N010210 A088032 A088791

001 002 001 001

Aug 06, 1993 Sep 09, 1984 Apr 15, 1983 Oct 05, 1984

A087547

001

N010210 A088059 A088007 A088837 A088089

001 001 001 001 001 Jul 29, 1983 Apr 19, 1983 Dec 24, 1985 Dec 28, 1982

PREDNISOLONE SODIUM PHOSPHATE

INJECTABLE; INJECTION HYDELTRASOL MERCK

EQ 20MG PHOSPHATE/ML

N011583

002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

PREDNISOLONE SODIUM PHOSPHATE
INJECTABLE; INJECTION PREDNISOLONE SODIUM PHOSPHATE WATSON LABS EQ 20MG PHOSPHATE/ML OINTMENT; OPHTHALMIC, OTIC HYDELTRASOL MERCK EQ 0.25% PHOSPHATE SOLUTION; ORAL PREDNISOLONE SODIUM PHOSPHATE VINTAGE PHARMS EQ 5MG BASE/5ML WE PHARMS EQ 5MG BASE/5ML SOLUTION/DROPS; OPHTHALMIC INFLAMASE FORTE NOVARTIS EQ 0.9% PHOSPHATE INFLAMASE MILD NOVARTIS EQ 0.11% PHOSPHATE METRETON SCHERING EQ 0.5% PHOSPHATE PREDAIR PHARMAFAIR EQ 0.11% PHOSPHATE PREDAIR FORTE PHARMAFAIR EQ 0.9% PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE AKORN EQ 0.11% PHOSPHATE EQ 0.9% PHOSPHATE ALCON UNIVERSAL EQ 0.11% PHOSPHATE EQ 0.9% PHOSPHATE BAUSCH AND LOMB EQ 0.11% PHOSPHATE SOLA BARNES HIND EQ 0.11% PHOSPHATE EQ 0.9% PHOSPHATE EQ 0.9% PHOSPHATE EQ 0.9% PHOSPHATE

6 - 275 (of 346)

A080517

001

N011028

001

A078416 A075181

001 001

Oct 31, 2007 Dec 23, 2002

A080751 A080751 A083834 A088415 A088165 A083358 A083358 A081043 A081044 A040065 A084171 A084168 A084169 A084172

002 001 001 001 001 001 002 001 001 001 001 001 001 001 Feb 29, 1984 Mar 28, 1983

Oct 24, 1991 Oct 24, 1991 Jul 29, 1994

PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM

SOLUTION/DROPS; OPHTHALMIC SULSTER AKORN EQ 0.23% PHOSPHATE;10%

A074511

001

Jul 30, 1996

PREDNISOLONE TEBUTATE
INJECTABLE; INJECTION HYDELTRA-TBA MERCK PREDNISOLONE TEBUTATE WATSON LABS

20MG/ML 20MG/ML

N010562 A083362

001 001 Feb 17, 1984

PREDNISONE
SOLUTION; ORAL PREDNISONE WOCKHARDT SYRUP; ORAL LIQUID PRED MURO TABLET; ORAL CORTAN HALSEY DELTA-DOME BAYER PHARMS DELTASONE PHARMACIA AND UPJOHN

5MG/5ML

A089726

001

Aug 02, 1988

5MG/5ML

A087611

002

Sep 07, 1982

20MG 5MG 2.5MG 5MG 10MG 20MG 50MG

A087480 A080293 N009986 N009986 N009986 N009986 N009986

001 001 005 002 006 007 008

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

PREDNISONE
TABLET; ORAL FERNISONE FERNDALE LABS METICORTEN SCHERING ORASONE SOLVAY

6 - 276 (of 346)

5MG 1MG 5MG 1MG 5MG 10MG 20MG 50MG 5MG 5MG 5MG 10MG 20MG 5MG 10MG 20MG 5MG 5MG 10MG 20MG 5MG 20MG 1MG 2.5MG 5MG 2.5MG 5MG 5MG 5MG 10MG 20MG 20MG 50MG 5MG 1MG 2.5MG 5MG 5MG 10MG 20MG 5MG 5MG 20MG 5MG 5MG 5MG 10MG 20MG 50MG 5MG 1MG 2.5MG 5MG 5MG 5MG

A083364 N009766 N009766 A083009 A083009 A083009 A083009 A085999 N010962 A084655 A089387 A089388 A089389 A089597 A089598 A089599 A083676 A088394 A088395 A088396 A080491 A085811 A084440 A084440 A084440 A080563 A080563 A080300 A080320 A084341 A084417 A085543 A086946 A080782 A080328 A080306 A080279 A080283 A084133 A084134 A084236 A080514 A084275 A086968 A080301 A080701 A086595 A084634 A086596 A085115 A080350 A080350 A080350 A083059 A084662

001 002 001 001 002 003 004 001 002 001 001 001 001 001 001 001 001 001 001 001 001 001 001 002 003 001 002 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 002 003 001 002 Nov Nov Nov Oct Oct Oct 06, 06, 06, 05, 05, 05, 1986 1986 1986 1987 1987 1987

PARACORT PARKE DAVIS PREDNICEN-M SCHWARZ PHARMA PREDNISONE AM THERAP

AMNEAL PHARMS NY

BUNDY DURAMED PHARMS BARR

Oct 04, 1983 Oct 04, 1983 Oct 04, 1983

ELKINS SINN EVERYLIFE

FERRANTE HALSEY HEATHER

IMPAX LABS INWOOD LABS

IVAX SUB TEVA PHARMS

KV PHARM LANNETT LEDERLE MARSHALL PHARMA MUTUAL PHARM

NYLOS PANRAY

PERRIGO PHARMAVITE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

PREDNISONE
TABLET; ORAL PREDNISONE PHOENIX LABS NY PUREPAC PHARM

6 - 277 (of 346)

PVT FORM REXALL ROXANE SANDOZ

SCHERER LABS SPERTI

SUPERPHARM

TEVA UDL

UPSHER SMITH VALEANT PHARM INTL VANGARD VITARINE WATSON LABS

WEST WARD WHITEWORTH TOWN PLSN

5MG 20MG 5MG 10MG 20MG 20MG 5MG 20MG 25MG 5MG 5MG 10MG 20MG 50MG 5MG 1MG 2.5MG 5MG 5MG 10MG 20MG 5MG 5MG 10MG 20MG 5MG 20MG 5MG 5MG 20MG 5MG 5MG 5MG 10MG 20MG 50MG 50MG 50MG 2.5MG 5MG 10MG 20MG 5MG

A080321 A083807 A080353 A086062 A086061 A085151 A080232 N017109 A087833 A080336 A084774 A089983 A085813 A089984 A080371 A080359 A080359 A080359 A088865 A088866 A088867 A080397 A087984 A087985 A087986 A087471 A087470 A080237 A087682 A087701 A080334 A080506 A085084 A087773 A086813 A086867 A087772 A088465 A084913 A080343 A089028 A084913 A080223

001 001 001 001 001 001 001 001 001 002 001 001 001 001 001 001 002 003 001 001 001 001 001 001 001 001 001 001 001 001 001 001 002 001 001 001 001 001 001 001 001 002 001

May 04, 1982

Jan 12, 1989 Jan 12, 1989

Oct 25, 1984 Oct 25, 1984 Oct 25, 1984 Jan 18, 1983 Jan 18, 1983 Jan 18, 1983

Jan 15, 1982 Jan 15, 1982

Jul 13, 1982

Jul 13, 1982 Jun 01, 1984

Jul 24, 1986

SERVISONE LEDERLE

PRILOCAINE HYDROCHLORIDE
INJECTABLE; INJECTION CITANEST ASTRAZENECA

1% 2% 3% 4%

N014763 N014763 N014763 N014763

004 005 003 007

CITANEST PLAIN ASTRAZENECA

PRIMIDONE
SUSPENSION; ORAL MYSOLINE NURO PHARMA

250MG/5ML

N010401

001

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DISCONTINUED DRUG PRODUCT LIST

PRIMIDONE
TABLET; ORAL PRIMIDONE WATSON LABS

6 - 278 (of 346)

250MG

A085052

001

PROBENECID
TABLET; ORAL BENEMID MERCK PROBENECID LEDERLE WATSON LABS

500MG 500MG 500MG

N007898 A086917 A086150

004 001 002

Apr 23, 1982

PROBUCOL
TABLET; ORAL LORELCO SANOFI AVENTIS US

250MG 500MG

N017535 N017535

001 002

Jul 06, 1988

PROCAINAMIDE HYDROCHLORIDE
CAPSULE; ORAL PROCAINAMIDE HYDROCHLORIDE ASCOT 250MG 375MG 500MG IVAX SUB TEVA PHARMS 250MG 375MG 500MG LANNETT 250MG 500MG LEDERLE 250MG 375MG 500MG ROXANE 250MG 500MG SANDOZ 250MG 375MG 500MG VANGARD 250MG 500MG WATSON LABS 250MG 250MG 250MG 375MG 375MG 500MG 500MG 500MG PROCAN PARKE DAVIS 250MG 375MG 500MG PROCAPAN PANRAY 250MG PRONESTYL APOTHECON 250MG 375MG 500MG INJECTABLE; INJECTION PROCAINAMIDE HYDROCHLORIDE ABRAXIS PHARM 100MG/ML 500MG/ML BAXTER HLTHCARE 100MG/ML

A087542 A087697 A087543 A084604 A084595 A084606 A083693 A084696 A086942 A086952 A086943 A088989 A088990 A089219 A089220 A089221 A087643 A087875 A083287 A083795 A085167 A084403 A087020 A084280 A084357 A087021 A085804 A087502 A085079 A083553 N007335 N007335 N007335

001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 002 001 004 003

Jan 08, 1982 Mar 01, 1983 Jan 08, 1982

Apr Apr Jul Jul Jul Jun Jun

26, 26, 01, 01, 01, 01, 01,

1985 1985 1986 1986 1986 1982 1982

A089415 A089416 A089029

001 001 001

Nov 17, 1986 Nov 17, 1986 Apr 17, 1986

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

PROCAINAMIDE HYDROCHLORIDE
INJECTABLE; INJECTION
PROCAINAMIDE HYDROCHLORIDE
BAXTER HLTHCARE 500MG/ML HOSPIRA 500MG/ML PHARMAFAIR 100MG/ML 500MG/ML SMITH AND NEPHEW 100MG/ML 500MG/ML SOLOPAK 500MG/ML WARNER CHILCOTT 100MG/ML 500MG/ML WATSON LABS 100MG/ML 500MG/ML PRONESTYL APOTHECON 100MG/ML 500MG/ML TABLET; ORAL PRONESTYL APOTHECON 250MG 375MG 500MG TABLET, EXTENDED RELEASE; ORAL

PROCAINAMIDE HYDROCHLORIDE

COPLEY PHARM 500MG 750MG 1GM INWOOD LABS 500MG PLIVA 250MG 500MG SANDOZ 250MG 500MG 500MG 750MG WATSON LABS 250MG 250MG 500MG 500MG 750MG 750MG 1GM PROCAN SR

PARKE DAVIS 250MG PARKEDALE 500MG 750MG 1GM PROCANBID KING PHARMS 500MG 1GM PRONESTYL-SR APOTHECON 500MG

6 - 279 (of 346)

A089030 A089537 A088824 A088830 A088530 A088531 A088532 A089528 A089529 A087079 A087080 N007335 N007335

001 001 001 001 001 001 001 001 001 001 001 002 005

Apr Aug Nov Nov Mar Mar Mar May May

17, 25, 20, 20, 04, 04, 04, 03, 03,

1986 1987 1985 1985 1985 1985 1985 1988 1988

N017371 N017371 N017371

001

002

003

A088974 A089438 A040111 A089840 A088958 A088959 A089369 A089284 A089370 A089371 A088533 A089026 A088534 A089027 A088535 A089042 A089520 A086468 A086065 A087510 A088489 N020545 N020545 A087361

001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001

001

001 001 001 002 001

Jul Mar Dec Mar Dec Dec Aug Jun Jan Aug Dec Oct Dec Oct Nov Oct Jan

22, 23, 13, 06, 02, 02, 14, 23, 09, 14, 03, 22, 03, 22, 03, 22, 15,

1985 1987 1996 1989 1985 1985 1987 1986 1987 1987 1984 1985 1984 1985 1984 1985 1987

Apr 01, 1982 Jan 16, 1985 Jan 31, 1996 Jan 31, 1996

PROCAINE HYDROCHLORIDE
INJECTABLE; INJECTION NOVOCAIN HOSPIRA

1% 2% 10% 1% 1% 2% 2%

A085362 A085362 A086797 A080384 A080421 A080384 A080421

003 004 001 002 001 003 002

PROCAINE HYDROCHLORIDE ABRAXIS PHARM

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

PROCAINE HYDROCHLORIDE
INJECTABLE; INJECTION PROCAINE HYDROCHLORIDE BEL MAR ELKINS SINN GD SEARLE LLC HOSPIRA MILES WATSON LABS

6 - 280 (of 346)

1% 2% 1% 2% 1% 2% 1% 2% 1% 2% 1% 1% 2% 2%

A080711 A080756 A083315 A083315 A086202 A086202 A080416 A080416 A080415 A080415 A080658 A083535 A080658 A083535

001 001 001 002 001 002 001 002 001 002 001 001 002 002

PROCAINE HYDROCHLORIDE; TETRACYCLINE HYDROCHLORIDE

INJECTABLE; INJECTION ACHROMYCIN LEDERLE TETRACYN PFIZER

40MG/VIAL;100MG/VIAL 40MG/VIAL;250MG/VIAL 40MG/VIAL;100MG/VIAL 40MG/VIAL;250MG/VIAL

N050276 N050276 A060285 A060285

001 003 002 003

PROCAINE MERETHOXYLLINE; THEOPHYLLINE

INJECTABLE; INJECTION DICURIN PROCAINE LILLY

100MG/ML;50MG/ML

N008869

001

PROCHLORPERAZINE
SUPPOSITORY; RECTAL COMPAZINE GLAXOSMITHKLINE

2.5MG 5MG 25MG 2.5MG 5MG 25MG

N011127 N011127 N011127 A040407 A040407 A040407

003 001 002 001 002 003 Jul 11, 2001 Jul 11, 2001 Jul 11, 2001

PROCHLORPERAZINE ABLE

PROCHLORPERAZINE EDISYLATE
CONCENTRATE; ORAL COMPAZINE GLAXOSMITHKLINE EQ PROCHLORPERAZINE ALPHARMA US PHARMS EQ PROCHLORPERAZINE EDISYLATE MORTON GROVE EQ INJECTABLE; INJECTION COMPAZINE GLAXOSMITHKLINE EQ PROCHLORPERAZINE BAXTER HLTHCARE EQ PROCHLORPERAZINE EDISYLATE BAXTER HLTHCARE EQ HOSPIRA EQ MARSAM PHARMS LLC EQ SMITH AND NEPHEW EQ TEVA PARENTERAL EQ WATSON LABS EQ

10MG BASE/ML 10MG BASE/ML 10MG BASE/ML

N011276 A087153 A088598

001 001 001 Jun 08, 1982 Oct 25, 1984

5MG BASE/ML 5MG BASE/ML 5MG 5MG 5MG 5MG 5MG 5MG BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML

N010742 A087759 A089523 A089703 A089675 A089251 A040505 A089530

002 001 001 001 001 001 001 001 Oct 01, 1982 May Apr Dec Dec May Jul 03, 07, 05, 04, 30, 08, 1988 1988 1988 1986 2003 1987

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

PROCHLORPERAZINE EDISYLATE
INJECTABLE; INJECTION PROCHLORPERAZINE EDISYLATE WATSON LABS EQ EQ WYETH AYERST EQ SYRUP; ORAL COMPAZINE GLAXOSMITHKLINE EQ PROCHLORPERAZINE EDISYLATE ALPHARMA US PHARMS EQ MORTON GROVE EQ

6 - 281 (of 346)

5MG BASE/ML 5MG BASE/ML 5MG BASE/ML

A089605 A089606 A086348

001 001 001

Jul 08, 1987 Jul 08, 1987

5MG BASE/5ML 5MG BASE/5ML 5MG BASE/5ML

N011188 A087154 A088597

001 001 001 Sep 01, 1982 Oct 25, 1984

PROCHLORPERAZINE MALEATE
CAPSULE, EXTENDED RELEASE; ORAL COMPAZINE GLAXOSMITHKLINE EQ 10MG BASE EQ 10MG BASE EQ 15MG BASE EQ 15MG BASE EQ 30MG BASE EQ 75MG BASE TABLET; ORAL COMPAZINE GLAXOSMITHKLINE EQ 5MG BASE EQ 10MG BASE EQ 25MG BASE PROCHLORPERAZINE WATSON LABS EQ 5MG BASE EQ 10MG BASE EQ 25MG BASE PROCHLORPERAZINE MALEATE DURAMED PHARMS BARR EQ 5MG BASE EQ 5MG BASE EQ 10MG BASE EQ 10MG BASE EQ 25MG BASE IVAX SUB TEVA PHARMS EQ 5MG BASE EQ 10MG BASE SANDOZ EQ 25MG BASE

N011000 N021019 N011000 N021019 N011000 N011000

001 001 002 002 003 004

Oct 06, 1999 Oct 06, 1999

N010571 N010571 N010571 A085580 A085178 A085579 A040207 A089484 A040207 A089485 A089486 A040162 A040162 A040101

001 002 003 001 001 001 001 001 002 001 001 001 002 003 May Jan May Jan Jan Jan Jan Jul 01, 20, 01, 20, 20, 20, 20, 19, 1997 1987 1997 1987 1987 1998 1998 1996

PROCYCLIDINE HYDROCHLORIDE
TABLET; ORAL KEMADRIN MONARCH PHARMS

2MG 5MG

N009818 N009818

005 003

PROGESTERONE
CAPSULE; ORAL PROMETRIUM ABBOTT LABS INJECTABLE; INJECTION PROGESTERONE LILLY

300MG

N019781

003

Oct 15, 1999

25MG/ML 50MG/ML INSERT, EXTENDED RELEASE; INTRAUTERINE PROGESTASERT ALZA 38MG

N009238 N009238

002 001

N017553

001

PROMAZINE HYDROCHLORIDE
CONCENTRATE; ORAL SPARINE WYETH AYERST

30MG/ML 100MG/ML

N010942 N010942

001 004

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

PROMAZINE HYDROCHLORIDE
INJECTABLE; INJECTION PROMAZINE HYDROCHLORIDE WATSON LABS 25MG/ML 50MG/ML SPARINE BAXTER HLTHCARE CORP 25MG/ML 50MG/ML SYRUP; ORAL SPARINE WYETH AYERST 10MG/5ML TABLET; ORAL SPARINE WYETH AYERST 10MG 25MG 50MG 100MG 200MG

6 - 282 (of 346)

A084510 A084517 N010349 N010349

001 001 008 006

N010942

003

N010348 N010348 N010348 N010348 N010348

006 001 002 003 004

PROMETHAZINE HYDROCHLORIDE
INJECTABLE; INJECTION PHENERGAN WYETH AYERST

25MG/ML 50MG/ML PROMETHAZINE HYDROCHLORIDE ABBOTT 25MG/ML 50MG/ML AKORN 25MG/ML 50MG/ML BEDFORD LABS 25MG/ML 50MG/ML BIONICHE PHARMA 25MG/ML HOSPIRA 50MG/ML 50MG/ML MARSAM PHARMS LLC 25MG/ML 50MG/ML SANDOZ 25MG/ML 50MG/ML WATSON LABS 25MG/ML 25MG/ML 50MG/ML 50MG/ML ZIPAN-25 ALTANA 25MG/ML ZIPAN-50 ALTANA 50MG/ML SUPPOSITORY; RECTAL PHENERGAN SHIONOGI INC 12.5MG 25MG 50MG PROMETHACON POLYMEDICA 25MG 50MG PROMETHAZINE HYDROCHLORIDE ABLE 12.5MG 25MG 50MG SYRUP; ORAL MYMETHAZINE FORTIS USL PHARMA 25MG/5ML PROMETH FORTIS ALPHARMA US PHARMS 25MG/5ML

N008857 N008857 A084223 A084222 A083955 A083955 A040524 A040524 A040471 A040372 A083838 A089463 A089477 A040593 A040593 A083532 A084591 A080629 A083532 A083997 A083997

002 003 001 001 002 001 001 002 001 002 002 001 001 001 002 001 001 002 002 001 002

Mar Mar Nov Jun May May Nov Nov

17, 17, 21, 08, 02, 02, 08, 08,

2004 2004 2002 2000 1988 1988 2006 2006

N010926 N010926 N011689 A084901 A084902 A040504 A040504 A040449

002 001 001 001 001 001 002 001 Apr 11, 2003 Apr 11, 2003 Feb 27, 2003

A087996 A084772

001 001

Jan 18, 1983

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

PROMETHAZINE HYDROCHLORIDE
SYRUP; ORAL PROMETH PLAIN ACTAVIS MID ATLANTIC 6.25MG/5ML PROMETHAZINE CENCI 6.25MG/5ML PROMETHAZINE HYDROCHLORIDE KV PHARM 6.25MG/5ML 25MG/5ML PHARM ASSOC 6.25MG/5ML WHITEWORTH TOWN PLSN 6.25MG/5ML PROMETHAZINE HYDROCHLORIDE PLAIN ANI PHARMS 6.25MG/5ML 25MG/5ML TABLET; ORAL PHENERGAN WYETH PHARMS INC 12.5MG 25MG 50MG PROMETHAZINE HYDROCHLORIDE ABBOTT 12.5MG 25MG 50MG ABLE 12.5MG 25MG 50MG IMPAX LABS 25MG IVAX SUB TEVA PHARMS 12.5MG 25MG 50MG LANNETT 12.5MG 25MG 50MG MUTUAL PHARM 12.5MG 25MG 50MG PVT FORM 12.5MG 25MG SANDOZ 12.5MG 12.5MG 25MG 50MG TABLICAPS 12.5MG 25MG TEVA 25MG WATSON LABS 12.5MG 12.5MG 12.5MG 25MG 25MG 50MG 50MG REMSED BRISTOL MYERS SQUIBB 25MG 50MG

6 - 283 (of 346)

A085953 A089013 A085388 A085385 A087518 A086395 N008381 N008381

001 001 001 001 001 001 004 003 Apr 18, 1984 Sep 20, 1985

N007935 N007935 N007935 A084160 A084166 A084539 A040558 A040558 A040558 A084214 A083604 A083603 A083613 A080949 A080949 A080949 A084555 A084554 A084557 A083214 A083658 A084176 A084233 A085146 A085146 A084080 A084027 A089109 A083401 A083712 A085986 A083204 A085684 A083403 A085664 A083176 A083176

002 003 004 001 001 001 001 002 003 002 001 001 001 001 002 003 001 001 001 001 001 002 001 001 002 001 001 001 001 001 001 001 001 001 001 002 001

Jul Jul Jul Jul

01, 01, 01, 07,

2004 2004 2004 1982

May 22, 2009

Sep 10, 1985

PROPANTHELINE BROMIDE
INJECTABLE; INJECTION PRO-BANTHINE GD SEARLE LLC TABLET; ORAL PRO-BANTHINE SHIRE

30MG/VIAL

N008843

001

7.5MG

N008732

003

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

PROPANTHELINE BROMIDE
TABLET; ORAL PRO-BANTHINE SHIRE PROPANTHELINE BROMIDE ASCOT HEATHER IMPAX LABS MYLAN PAR PHARM PVT FORM ROXANE SANDOZ TABLICAPS WATSON LABS

6 - 284 (of 346)

15MG 15MG 15MG 15MG 15MG 15MG 15MG 7.5MG 15MG 15MG 15MG 15MG

N008732 A087663 A085780 A084541 A083706 A088377 A080977 A080927 A080928 A084428 A083029 A083151

002 001 001 002 001 001 001 001 001 001 002 001 Oct 25, 1982

Dec 08, 1983

PROPARACAINE HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC KAINAIR PHARMAFAIR 0.5% PARACAINE OPTOPICS 0.5% PROPARACAINE HYDROCHLORIDE SOLA BARNES HIND 0.5% 0.5%

A088087 A087681 A084144 A084151

001 001 001 001

Jun 07, 1983 Aug 05, 1982

PROPIOLACTONE
SOLUTION; IRRIGATION BETAPRONE FOREST LABS

N/A

N011657

001

PROPIOMAZINE HYDROCHLORIDE
INJECTABLE; INJECTION LARGON BAXTER HLTHCARE CORP

20MG/ML

N012382

002

PROPOFOL
INJECTABLE; INJECTION DIPRIVAN APP PHARMS PROPOFOL BEDFORD TEVA PARENTERAL

10MG/ML 10MG/ML 10MG/ML

N019627 A074848 A075392

001 001 001

Oct 02, 1989 Apr 19, 2005 Sep 19, 2000

PROPOXYPHENE HYDROCHLORIDE
CAPSULE; ORAL DARVON XANODYNE PHARM

32MG 65MG

N010997 N010997 A080530 A083544 A083538 A083184 A083317 A083597 A083186 A083528 A040569

001 003 001 001 002 001 001 001 001 001 001

DOLENE HERITAGE PHARMS INC 65MG KESSO-GESIC MK LABS 65MG PROPHENE 65 HALSEY 65MG PROPOXYPHENE HYDROCHLORIDE ALRA 65MG IMPAX LABS 65MG IVAX SUB TEVA PHARMS 32MG MUTUAL PHARM 65MG MYLAN 32MG 65MG

Dec 16, 2004

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

PROPOXYPHENE HYDROCHLORIDE
CAPSULE; ORAL PROPOXYPHENE HYDROCHLORIDE MYLAN 65MG NEXGEN PHARMA INC 65MG PAR PHARM 65MG PUREPAC PHARM 65MG PVT FORM 32MG 65MG ROXANE 32MG 65MG SANDOZ 32MG 65MG 65MG 65MG 65MG TEVA 65MG VALEANT PHARM INTL 65MG VINTAGE PHARMS 65MG WATSON LABS 65MG 65MG WEST WARD 65MG WHITEWORTH TOWN PLSN 65MG PROPOXYPHENE HYDROCHLORIDE 65 WARNER CHILCOTT 65MG

6 - 285 (of 346)

A083299 A083185 A080269 A083278 A083464 A083113 A083089 A083089 A084014 A083125 A083688 A083870 A086495 A088615 A080783 A040908 A080908 A085190 A083501 A084551 A083786

001 001 001 001 001 001 001 002 001 002 001 002 001 001 001 001 002 001 001 001 001

Oct 22, 1984 Jul 17, 2009

PROPOXYPHENE NAPSYLATE
SUSPENSION; ORAL DARVON-N AAIPHARMA LLC TABLET; ORAL DARVON-N XANODYNE PHARM

50MG/5ML

N016861

001

100MG

N016862

002

PROPRANOLOL HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL PROPRANOLOL HYDROCHLORIDE INWOOD LABS 60MG 80MG 120MG 160MG CONCENTRATE; ORAL PROPRANOLOL HYDROCHLORIDE INTENSOL ROXANE 80MG/ML INJECTABLE; INJECTION PROPRANOLOL HYDROCHLORIDE SMITH AND NEPHEW 1MG/ML 1MG/ML SOLOPAK 1MG/ML SOLUTION; ORAL PROPRANOLOL HYDROCHLORIDE MORTON GROVE 20MG/5ML 40MG/5ML SUSPENSION; ORAL INDERAL WYETH AYERST 10MG/ML TABLET; ORAL INDERAL AKRIMAX PHARMS 10MG 20MG 90MG PROPRANOLOL HYDROCHLORIDE CLONMEL HLTHCARE 10MG 20MG

A072499 A072500 A072501 A072502

001 001 001 001

Apr Apr Apr Apr

11, 11, 11, 11,

1989 1989 1989 1989

A071388

001

May 15, 1987

A070135 A070137 A070136

001 001 001

Apr 15, 1986 Apr 15, 1986 Apr 15, 1986

A071984 A071985

001 001

Mar 03, 1989 Mar 03, 1989

N019536

001

Dec 12, 1986

N016418 N016418 N016418 A070125 A070126

001 003 010 001 001

Oct 18, 1982 Jul 30, 1985 Jul 30, 1985

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

PROPRANOLOL HYDROCHLORIDE
TABLET; ORAL PROPRANOLOL HYDROCHLORIDE CLONMEL HLTHCARE 40MG 60MG 80MG 90MG DURAMED PHARMS BARR 10MG 20MG 40MG 60MG 80MG 90MG INTERPHARM 10MG 20MG 40MG 80MG IVAX SUB TEVA PHARMS 10MG 20MG 40MG 60MG 80MG LEDERLE 10MG 20MG 40MG 80MG MUTUAL PHARM 10MG 20MG 40MG 60MG 80MG MYLAN 60MG PAR PHARM 90MG PLIVA 90MG PUREPAC PHARM 10MG 20MG 40MG 60MG 80MG ROXANE 10MG 20MG 40MG 60MG 80MG 90MG SANDOZ 10MG 10MG 20MG 20MG 40MG 40MG 60MG 60MG 80MG 80MG 90MG SCHERING 10MG 20MG 40MG 60MG 80MG SUPERPHARM 10MG 20MG

6 - 286 (of 346)

A070127 A071495 A070128 A071496 A070306 A070307 A070308 A070309 A070310 A071327 A071368 A071369 A071370 A071371 A072063 A072066 A072067 A072068 A072069 A072117 A072118 A072119 A072120 A070319 A070320 A070103 A070321 A070322 A072275 A071288 A071977 A070814 A070815 A070816 A070817 A070757 A070516 A070517 A070518 A070519 A070520 A070521 A070663 A071658 A070664 A071687 A070665 A071688 A070666 A072197 A070667 A071689 A072198 A070120 A070121 A070122 A070123 A070124 A071515 A071516

001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001

Jul Dec Jul Dec Sep Sep Sep Oct Sep Oct May May May May Jul Jul Jul Jul Jul Jun Jun Jun Jun Oct Oct Oct Sep Aug Jun Oct Apr Nov Nov Nov Nov Nov Jul Jul Jul Sep Jul Sep Jun Jul Jun Jul Jun Jul Oct Jul Jun Jul Jul Aug Aug Aug Oct Aug Jun Jun

30, 31, 30, 31, 09, 09, 09, 01, 09, 01, 05, 05, 05, 05, 29, 29, 29, 29, 29, 23, 23, 23, 23, 22, 22, 22, 24, 04, 09, 22, 06, 03, 03, 03, 03, 03, 07, 07, 07, 24, 07, 24, 13, 05, 13, 05, 13, 05, 10, 05, 13, 05, 05, 06, 06, 06, 29, 06, 08, 08,

1985 1987 1985 1987 1985 1985 1985 1986 1985 1986 1987 1987 1987 1987 1988 1988 1988 1988 1988 1988 1988 1988 1988 1985 1985 1985 1986 1986 1989 1986 1988 1986 1986 1986 1986 1986 1986 1986 1986 1986 1986 1986 1986 1988 1986 1988 1986 1988 1986 1988 1986 1988 1988 1985 1985 1985 1986 1985 1988 1988

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

PROPRANOLOL HYDROCHLORIDE
TABLET; ORAL PROPRANOLOL HYDROCHLORIDE SUPERPHARM 40MG 80MG TEVA 10MG 20MG 40MG WARNER CHILCOTT 10MG 20MG 40MG 60MG 80MG WATSON LABS 10MG 10MG 10MG 20MG 20MG 20MG 40MG 40MG 40MG 60MG 60MG 60MG 60MG 80MG 80MG 80MG 90MG 90MG

6 - 287 (of 346)

A071517 A071518 A070232 A070233 A070234 A070438 A070439 A070440 A070441 A070442 A070140 A070378 A070548 A070141 A070379 A070549 A070142 A070380 A070550 A070143 A070381 A071098 A071791 A070144 A070382 A070551 A071183 A071792

001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001

Jun Jun Oct Jun Jun Sep Sep Sep Sep Sep Jul Mar Jul Jul Mar Apr Jul Mar Apr Jan Mar Oct Jul Jul Mar Jul Oct Jul

08, 08, 07, 23, 23, 15, 15, 15, 24, 15, 30, 19, 10, 30, 19, 11, 30, 19, 11, 15, 19, 06, 15, 30, 19, 10, 06, 15,

1988 1988 1987 1986 1986 1986 1986 1986 1986 1986 1985 1987 1986 1985 1987 1986 1985 1987 1986 1987 1987 1986 1987 1985 1987 1986 1986 1987

PROPYLIODONE
SUSPENSION; INTRATRACHEAL DIONOSIL AQUEOUS GLAXOSMITHKLINE 50% DIONOSIL OILY GLAXOSMITHKLINE 60%

N009309 N009309

001 002

PROPYLTHIOURACIL
TABLET; ORAL PROPYLTHIOURACIL ABBOTT ANABOLIC HALSEY IMPAX LABS IVAX SUB TEVA PHARMS LANNETT LILLY MUTUAL PHARM PERRIGO TABLICAPS WATSON LABS

50MG 50MG 50MG 50MG 50MG 50MG 50MG 50MG 50MG 50MG 50MG 50MG

A084075 A080285 A080015 A080159 A080215 A080016 N006213 A083982 A084543 A080840 A080932 A085201

001 001 001 001 001 001 001 001 001 001 001 001

PROTAMINE SULFATE
INJECTABLE; INJECTION PROTAMINE SULFATE BAXTER HLTHCARE LILLY PHARMACIA AND UPJOHN

10MG/ML 10MG/ML 10MG/ML 50MG/VIAL 250MG/VIAL

A089474 A089475 N006460 N007413 N007413

001 001 002 001 002

Nov 05, 1986 Nov 05, 1986

Aug 02, 1984

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

PROTEIN HYDROLYSATE
INJECTABLE; INJECTION AMINOSOL 5% ABBOTT HYPROTIGEN 5% B BRAUN

6 - 288 (of 346)

5% 5%

N005932 N006170

012 003

Jan 31, 1985 Jan 10, 1984

PROTIRELIN
INJECTABLE; INJECTION THYPINONE ABBOTT THYREL TRH FERRING

0.5MG/ML 0.5MG/ML

N017638 N018087

001 001

PROTOKYLOL HYDROCHLORIDE
TABLET; ORAL VENTAIRE SANOFI AVENTIS US

2MG

A083459

001

PROTRIPTYLINE HYDROCHLORIDE
TABLET; ORAL VIVACTIL ODYSSEY PHARMS

5MG 10MG

N016012 N016012

001 002

PSEUDOEPHEDRINE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL NOVAFED SANOFI AVENTIS US 120MG SUDAFED 12 HOUR GLAXOSMITHKLINE 120MG

N017603 N017941

001 002

PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE; ORAL ACTIFED GLAXOSMITHKLINE 120MG;5MG TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES KV PHARM 120MG;5MG SYRUP; ORAL ACTAHIST CENCI 30MG/5ML;1.25MG/5ML HISTAFED CENCI 30MG/5ML;1.25MG/5ML MYFED USL PHARMA 30MG/5ML;1.25MG/5ML TRILITRON NEWTRON PHARMS 30MG/5ML;1.25MG/5ML TABLET; ORAL ALLERFED PVT FORM 60MG;2.5MG CORPHED SANDOZ 60MG;2.5MG PSEUDOEPHEDRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE SANDOZ 60MG;2.5MG TRILITRON NEWTRON PHARMS 60MG;2.5MG TRIPHED TEVA 60MG;2.5MG TRIPROLIDINE AND PSEUDOEPHEDRINE WATSON LABS 60MG;2.5MG WEST WARD 60MG;2.5MG TRIPROLIDINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE IVAX SUB TEVA PHARMS 60MG;2.5MG

N018996 A071798

001 001

Jun 17, 1985 Mar 16, 1989

A088344 A088283 A088116 A088474

001 001 001 001

Feb 09, 1984 Apr 20, 1984 Mar 04, 1983 Feb 12, 1985

A088860 A088602 A088193 A088515 A088630 A088318 A088117 A085273

001 001 001 001 001 002 001 001

Jan 31, 1985 Apr 11, 1985 May 17, 1983 Jan 09, 1985 May 17, 1984 Jan 13, 1984 Apr 19, 1983 Dec 12, 1984

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE
TABLET; ORAL TRIPROLIDINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE SUPERPHARM 60MG;2.5MG TABLET, EXTENDED RELEASE; ORAL TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES KV PHARM 120MG;5MG

6 - 289 (of 346)

A088578

001

Feb 21, 1985

A072758

001

Nov 25, 1991

PSEUDOEPHEDRINE POLISTIREX
SUSPENSION, EXTENDED RELEASE; ORAL PSEUDO-12 UCB INC EQ 60MG HCL/5ML

N019401

001

Jun 19, 1987

PYRIDOSTIGMINE BROMIDE
TABLET; ORAL PYRIDOSTIGMINE BROMIDE BARR SOLVAY US ARMY

30MG 60MG 30MG 30MG

A040512 A040512 A089572 N020414

002 001 001 001

Jul Oct Nov Feb

20, 08, 27, 05,

2005 2003 1990 2003

PYRIDOXINE HYDROCHLORIDE
INJECTABLE; INJECTION HEXA-BETALIN LILLY 100MG/ML PYRIDOXINE HYDROCHLORIDE AKORN 100MG/ML BEL MAR 100MG/ML DELL LABS 50MG/ML 100MG/ML ELKINS SINN 100MG/ML LUITPOLD 100MG/ML WATSON LABS 100MG/ML 100MG/ML

A080854 A087967 A080761 A083771 A083772 A080581 A080669 A080572 A083760

001 001 001 001 001 001 001 001 001 Oct 01, 1982

PYRILAMINE MALEATE
TABLET; ORAL PYRILAMINE MALEATE IMPAX LABS WATSON LABS

25MG 25MG

A080808 A085231

001 001

PYRIMETHAMINE; SULFADOXINE
TABLET; ORAL FANSIDAR ROCHE

25MG;500MG

N018557

001

PYRITHIONE ZINC
LOTION; TOPICAL HEAD & SHOULDERS CONDITIONER WARNER CHILCOTT 0.3%

N019412

002

Mar 10, 1986

PYRVINIUM PAMOATE
SUSPENSION; ORAL POVAN PARKE DAVIS TABLET; ORAL POVAN PARKE DAVIS

EQ 50MG BASE/5ML

N011964

001

EQ 50MG BASE

N012485

002

QUAZEPAM
TABLET; ORAL DORAL QUESTCOR PHARMS

7.5MG

N018708

003

Feb 26, 1987

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

QUETIAPINE FUMARATE
TABLET; ORAL SEROQUEL ASTRAZENECA

6 - 290 (of 346)

EQ 150MG BASE

N020639

004

Dec 20, 1998

QUINAPRIL HYDROCHLORIDE
TABLET; ORAL QUINAPRIL HYDROCHLORIDE ACTAVIS TOTOWA EQ EQ EQ EQ

5MG BASE 10MG BASE 20MG BASE 40MG BASE

A076459 A076459 A076459 A076459

001 002 003 004

Dec Dec Dec Dec

22, 22, 22, 22,

2004 2004 2004 2004

QUINESTROL
TABLET; ORAL ESTROVIS PARKE DAVIS

0.1MG 0.2MG

N016768 N016768

002 003

QUINETHAZONE
TABLET; ORAL HYDROMOX LEDERLE

50MG

N013264

001

QUINETHAZONE; RESERPINE
TABLET; ORAL HYDROMOX R LEDERLE

50MG;0.125MG

N013927

001

QUINIDINE GLUCONATE
TABLET; ORAL QUINACT BAYER HLTHCARE

266MG 400MG TABLET, EXTENDED RELEASE; ORAL DURAQUIN WARNER CHILCOTT 330MG QUINAGLUTE BAYER HLTHCARE 324MG QUINALAN LANNETT 324MG QUINATIME WATSON LABS 324MG QUINIDINE GLUCONATE ASCOT 324MG HALSEY 324MG ROXANE 324MG SANDOZ 324MG SUPERPHARM 324MG WATSON LABS 324MG

A085978 A086099

001 001

N017917 N016647 A088081 A087448 A088582 A089476 A088431 A089894 A089164 A087785

001 001 001 001 001 001 001 001 001 001 Jun Apr Jan Dec Nov Jan 17, 10, 06, 15, 21, 24, 1985 1987 1984 1988 1985 1983 Feb 10, 1986

QUINIDINE POLYGALACTURONATE
TABLET; ORAL CARDIOQUIN PHARM RES ASSOC

275MG

N011642

002

QUINIDINE SULFATE
CAPSULE; ORAL CIN-QUIN SOLVAY QUINIDINE SULFATE LILLY

200MG 300MG 200MG

A085296 A085297 A085103

001 001 001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

QUINIDINE SULFATE
TABLET; ORAL CIN-QUIN SOLVAY

6 - 291 (of 346)

100MG 200MG 300MG 200MG 200MG 200MG 200MG 200MG 200MG 200MG 200MG 200MG 200MG 200MG 200MG 200MG 100MG 200MG 200MG 200MG 200MG 300MG 200MG 200MG 300MG 200MG 200MG 200MG 200MG 200MG 200MG 200MG 100MG 200MG 200MG 200MG 200MG 300MG ORAL 300MG

A085299 A084932 A085298 A084177 A087011 A083808 A083622 A083439 A083583 A083347 A084549 A085175 A085276 A083743 A086176 A085038 A081029 A085322 A084627 A084003 A083640 A085632 A084631 A084914 A089839 A085068 A088973 A087837 A083393 A087909 A083963 A083879 A085584 A085140 A083862 A085444 A083576 A085222

001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 002 001 001 001 001

QUINIDINE SULFATE BARR CLONMEL HLTHCARE CONTRACT PHARMACAL ELKINS SINN EVERYLIFE HALSEY IMPAX LABS IVAX SUB TEVA PHARMS KING PHARMS KV PHARM LANNETT LEDERLE LILLY MUTUAL PHARM PERRIGO PHARMAVITE PUREPAC PHARM ROXANE SANDOZ

Apr 14, 1989

Sep 29, 1988 Apr 10, 1985 Apr 14, 1982 Jul 13, 1982

SCHERER LABS SUPERPHARM USL PHARMA VALEANT PHARM INTL VANGARD VINTAGE PHARMS WARNER CHILCOTT WATSON LABS WEST WARD WHITEWORTH TOWN PLSN QUINORA KEY PHARMS SCHERING TABLET, EXTENDED RELEASE; QUINIDEX WYETH PHARMS INC

N012796

002

RABEPRAZOLE SODIUM
TABLET, DELAYED RELEASE; ORAL ACIPHEX EISAI INC 10MG

N020973

001

May 29, 2002

RAMIPRIL
CAPSULE; ORAL RAMIPRIL ACTAVIS ELIZABETH

1.25MG 2.5MG 5MG 10MG

A077513 A077513 A077513 A077513

001 002 003 004

Jun Jun Jun Jun

18, 18, 18, 18,

2008 2008 2008 2008

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

RANITIDINE BISMUTH CITRATE
TABLET; ORAL TRITEC GLAXOSMITHKLINE

6 - 292 (of 346)

400MG

N020559

001

Aug 08, 1996

RANITIDINE HYDROCHLORIDE
CAPSULE; ORAL RANITIDINE HYDROCHLORIDE MYLAN EQ 150MG BASE EQ 300MG BASE TEVA EQ 150MG BASE EQ 300MG BASE ZANTAC 150 GLAXOSMITHKLINE EQ 150MG BASE ZANTAC 300 GLAXOSMITHKLINE EQ 300MG BASE GRANULE, EFFERVESCENT; ORAL ZANTAC 150 GLAXOSMITHKLINE EQ 150MG BASE/PACKET INJECTABLE; INJECTION RANITIDINE HYDROCHLORIDE BEDFORD EQ 25MG BASE/ML ZANTAC IN PLASTIC CONTAINER GLAXOSMITHKLINE EQ 50MG BASE/100ML TABLET; ORAL RANITIDINE HYDROCHLORIDE BOEHRINGER INGELHEIM EQ 150MG BASE EQ 300MG BASE MYLAN EQ 150MG BASE EQ 300MG BASE RANBAXY EQ 75MG BASE EQ 75MG BASE EQ 150MG BASE EQ 150MG BASE EQ 300MG BASE EQ 300MG BASE SANDOZ EQ 75MG BASE TABLET, EFFERVESCENT; ORAL ZANTAC 150 GLAXOSMITHKLINE EQ 150MG BASE ZANTAC 75 BOEHRINGER INGELHEIM EQ 75MG BASE

A075564 A075564 A075557 A075557 N020095 N020095

001 002 001 002 001 002

Oct Oct Oct Oct

27, 27, 31, 31,

2000 2000 2003 2003

Mar 08, 1994 Mar 08, 1994

N020251

002

Mar 31, 1994

A074764 N019593

001 001

Nov 19, 2004 Dec 17, 1986

A074662 A074662 A074552 A074552 A075132 A075254 A075000 A075439 A075000 A075439 A075519

001 002 001 002 001 001 001 001 002 002 001

Aug Aug Jul Jul Jan Jan Jan Apr Jan Apr Sep

29, 29, 30, 30, 14, 14, 30, 19, 30, 19, 26,

1997 1997 1998 1998 2000 2000 1998 2000 1998 2000 2002

N020251 N020745

001 001

Mar 31, 1994 Feb 26, 1998

RAPACURONIUM BROMIDE
INJECTABLE; INJECTION RAPLON ORGANON USA INC

100MG/VIAL 200MG/VIAL

N020984 N020984

001 002

Aug 18, 1999 Aug 18, 1999

RAUWOLFIA SERPENTINA ROOT

TABLET; ORAL HIWOLFIA BOWMAN PHARMS

50MG 50MG 100MG 50MG 50MG 100MG 50MG 100MG

N009276 N009276 N009276 N010581 N009278 N009278 N008842 N008842

003 005 004 001 001 002 001 002

HYSERPIN PHYS PRODS VA KOGLUCOID PANRAY RAUDIXIN APOTHECON

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

RAUWOLFIA SERPENTINA ROOT
TABLET; ORAL RAUSERPIN FERNDALE LABS RAUVAL PAL PAK RAUWOLFIA SERPENTINA BUNDY HALSEY IMPAX LABS IVAX SUB TEVA PHARMS PUREPAC PHARM PVT FORM SOLVAY TABLICAPS VALEANT PHARM INTL WATSON LABS WOLFINA FOREST PHARMS

6 - 293 (of 346)

50MG 100MG 50MG 100MG 50MG 100MG 50MG 100MG 50MG 100MG 50MG 100MG 50MG 100MG 50MG 100MG 50MG 100MG 50MG 100MG 50MG 100MG 50MG 100MG 50MG 100MG

N009926 N009926 N009108 N009108 N009477 N009477 A080498 A080498 N009273 N009273 N011521 N011521 A080842 A080842 A080583 A080583 A080500 A080500 A083867 A083444 N009668 N009668 A080907 A080914 N009255 N009255

002 004 002 004 001 002 001 002 001 002 001 002 001 002 001 002 001 002 001 001 001 002 001 001 008 006

RESCINNAMINE
CAPSULE; ORAL CINNASIL PANRAY TABLET; ORAL MODERIL PFIZER

0.5MG

A084736

001

0.25MG 0.5MG

N010686 N010686

003 006

RESERPINE
ELIXIR; ORAL SERPASIL NOVARTIS INJECTABLE; INJECTION SANDRIL LILLY SERPASIL NOVARTIS TABLET; ORAL HISERPIA BOWMAN PHARMS RAU-SED BRISTOL MYERS SQUIBB

0.2MG/4ML

N009115

005

2.5MG/ML 2.5MG/ML

N010012 N009434

001 002

0.1MG 0.25MG 0.1MG 0.25MG 0.5MG 1MG 0.25MG 0.1MG 0.25MG

N009631 N009631 N009357 N009357 N009357 N009357 A080721 A083058 A083058

002 004 001 004 006 008 002 001 002

RESERPINE BARR BELL PHARMA

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

RESERPINE
TABLET; ORAL RESERPINE BUNDY ELKINS SINN EVERYLIFE

6 - 294 (of 346)

HALSEY

IMPAX LABS IVAX SUB TEVA PHARMS MARSHALL PHARMA MK LABS MYLAN PHARMAVITE PUREPAC PHARM PVT FORM

REXALL ROXANE SOLVAY TABLICAPS TEVA VALEANT PHARM INTL WATSON LABS

WEST WARD

WHITEWORTH TOWN PLSN

0.1MG 0.25MG 0.1MG 0.25MG 0.1MG 0.25MG 0.5MG 1MG 0.1MG 0.25MG 1MG 0.1MG 0.25MG 0.1MG 0.25MG 0.1MG 0.25MG 0.1MG 0.25MG 1MG 0.25MG 0.1MG 0.25MG 0.1MG 0.25MG 0.25MG 1MG 0.25MG 0.1MG 0.25MG 0.25MG 0.25MG 0.1MG 0.25MG 0.1MG 0.25MG 0.1MG 0.25MG 0.25MG 1MG 0.1MG 0.25MG 1MG 0.1MG 0.25MG 1MG 0.1MG 0.25MG 0.1MG 0.25MG 1MG 0.1MG 0.25MG 1MG 0.1MG 0.25MG

N009663 N009663 A083145 A083145 N010441 N010441 N010441 N010441 A080457 A080457 A080457 N009627 N009627 N011185 N011185 A080492 A080492 A080525 A080525 A084974 A084663 A080753 A080753 A086117 A080582 A085775 A080582 A080637 N009859 N009859 A080446 A085207 A089020 A089019 N009667 N009667 A080679 A080393 A085401 A080749 A080975 A080975 A080975 A080723 A080723 A080723 N009376 N009376 N009391 N009391 N009391 N009115 N009115 N009115 N009453 N009453

001 003 001 002 001 002 003 004 002 001 003 001 002 001 002 001 002 002 001 001 001 002 001 001 001 001 002 001 001 002 001 001 001 001 001 002 001 001 001 001 001 002 003 001 002 003 004 001 001 002 004 001 003 004 001 002

Mar 07, 1985 Mar 07, 1985

SANDRIL LILLY SERPANRAY PANRAY

SERPASIL NOVARTIS

SERPATE VALE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

RESERPINE
TABLET; ORAL SERPIVITE VITARINE

6 - 295 (of 346)

0.25MG

N009645

002

RESERPINE; TRICHLORMETHIAZIDE
TABLET; ORAL METATENSIN #2 SANOFI AVENTIS US 0.1MG;2MG METATENSIN #4 SANOFI AVENTIS US 0.1MG;4MG NAQUIVAL SCHERING 0.1MG;4MG TRICHLORMETHIAZIDE W/ RESERPINE WATSON LABS 0.1MG;4MG

N012972 N012972 N012265 A085248

001 002 003 001

RIBAVIRIN
TABLET; ORAL COPEGUS ROCHE

400MG

N021511

002

Jun 21, 2005

RIFAMPIN
CAPSULE; ORAL RIMACTANE PROSAM LABS

300MG

N050429

001

RIMANTADINE HYDROCHLORIDE
SYRUP; ORAL FLUMADINE FOREST LABS 50MG/5ML TABLET; ORAL RIMANTADINE HYDROCHLORIDE ACTAVIS TOTOWA 100MG

N019650

001

Sep 17, 1993

A076375

001

Jan 14, 2003

RISEDRONATE SODIUM
TABLET; ORAL ACTONEL WARNER CHILCOTT

75MG

N020835

004

Apr 16, 2007

RISPERIDONE
TABLET; ORAL RISPERDAL JANSSEN PHARMS RISPERIDONE ACTAVIS TOTOWA

5MG 0.25MG 0.5MG 1MG 2MG 3MG 4MG 0.25MG 0.5MG 1MG 2MG 3MG 4MG 0.25MG 0.5MG 1MG 2MG 3MG 4MG 0.25MG

N020272 A078071 A078071 A078071 A078071 A078071 A078071 A078828 A078828 A078828 A078828 A078828 A078828 A077784 A077784 A077784 A077784 A077784 A077784 A078187

005 001 002 003 004 005 006 001 002 003 004 005 006 001 002 003 004 005 006 001

Dec 29, 1993 Jun Jun Jun Jun Jun Jun Mar Mar Mar Mar Mar Mar Jun Jun Jun Jun Jun Jun Oct 17, 17, 17, 17, 17, 17, 23, 23, 23, 23, 23, 23, 08, 08, 08, 08, 08, 08, 22, 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2010 2010 2010 2010 2010 2010 2009

CADISTA PHARMS

RATIOPHARM

SYNTHON PHARMS

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

RISPERIDONE
TABLET; ORAL RISPERIDONE SYNTHON PHARMS

6 - 296 (of 346)

0.5MG 1MG 2MG 3MG 4MG

A078187 A078187 A078187 A078187 A078187

002 003 004 005 006

Oct Oct Oct Oct Oct

22, 22, 22, 22, 22,

2009 2009 2009 2009 2009

RITODRINE HYDROCHLORIDE
INJECTABLE; INJECTION RITODRINE HYDROCHLORIDE ABRAXIS PHARM 10MG/ML 15MG/ML HOSPIRA 10MG/ML 15MG/ML RITODRINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER HOSPIRA 30MG/100ML YUTOPAR ASTRAZENECA 10MG/ML 15MG/ML TABLET; ORAL YUTOPAR ASTRAZENECA 10MG

A071188 A071189 A071618 A071619 A071438 N018580 N018580

001 001 001 001 001 001 002

Jul Jul Feb Feb

23, 23, 28, 28,

1987 1987 1991 1991

Jan 22, 1991

N018555

001

RITONAVIR
CAPSULE; ORAL NORVIR ABBOTT

100MG

N020680

001

Mar 01, 1996

ROCURONIUM BROMIDE
INJECTABLE; INJECTION ZEMURON SCHERING

10MG/ML (10MG/ML)

N020214

002

Mar 17, 1994

ROFECOXIB
SUSPENSION; ORAL VIOXX MERCK TABLET; ORAL VIOXX MERCK

12.5MG/5ML 25MG/5ML

N021052 N021052

001 002

May 20, 1999 May 20, 1999

12.5MG 25MG 50MG

N021042 N021042 N021042

001 002 003

May 20, 1999 May 20, 1999 Feb 25, 2000

ROPINIROLE HYDROCHLORIDE
TABLET, EXTENDED RELEASE; ORAL REQUIP XL SMITHKLINE BEECHAM EQ 3MG BASE

N022008

002

Jun 13, 2008

ROSE BENGAL SODIUM I-131

INJECTABLE; INJECTION ROBENGATOPE BRACCO

0.5mCi/VIAL 1mCi/VIAL 2mCi/VIAL

N016224 N016224 N016224 N017318

001 002 003 001

SODIUM ROSE BENGAL I 131 SORIN 0.5mCi/ML

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

ROTIGOTINE
FILM, EXTENDED RELEASE; TRANSDERMAL NEUPRO
UCB INC
2MG/24HR 4MG/24HR 6MG/24HR

6 - 297 (of 346)

N021829 N021829 N021829

001 002 003

May 09, 2007 May 09, 2007 May 09, 2007

RUFINAMIDE
TABLET; ORAL BANZEL EISAI INC

100MG

N021911

001

Nov 14, 2008

SAFFLOWER OIL
INJECTABLE; INJECTION LIPOSYN 10% ABBOTT LIPOSYN 20% ABBOTT

10% (10GM/100ML) 20% (20GM/100ML)

N018203 N018614

001 001

SALMETEROL XINAFOATE
AEROSOL, METERED; INHALATION SEREVENT GLAXOSMITHKLINE EQ 0.021MG BASE/INH

N020236

001

Feb 04, 1994

SAQUINAVIR
CAPSULE; ORAL FORTOVASE HOFFMANN LA ROCHE

200MG

N020828

001

Nov 07, 1997

SARALASIN ACETATE
INJECTABLE; INJECTION SARENIN PROCTER AND GAMBLE

EQ 0.6MG BASE/ML

N018009

001

SECOBARBITAL SODIUM
CAPSULE; ORAL SECOBARBITAL SODIUM ANABOLIC BARR EVERYLIFE HALSEY IVAX PHARMS KV PHARM LANNETT PARKE DAVIS PERRIGO PUREPAC PHARM VALEANT PHARM INTL VITARINE WATSON LABS WEST WARD WHITEWORTH TOWN PLSN WYETH AYERST INJECTABLE; INJECTION SECOBARBITAL SODIUM ELKINS SINN WYETH AYERST SECONAL SODIUM LILLY

100MG 100MG 100MG 100MG 100MG 100MG 50MG 100MG 100MG 100MG 100MG 100MG 100MG 100MG 100MG 100MG 100MG 100MG

A084422 A084225 A085895 A084676 A085869 A085285 A085909 A085903 A084762 A084561 A085867 A085477 A085898 A086273 A085792 A084926 A085798 A086390

001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001

100MG/VIAL 50MG/ML 50MG/ML

A083281 A083262 N007392

001 001 002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

SECOBARBITAL SODIUM
SUPPOSITORY; RECTAL SECONAL SODIUM LILLY

6 - 298 (of 346)

30MG 60MG 120MG 200MG

A086530 A086530 A086530 A086530

001 002 003 004

SECRETIN
INJECTABLE; INJECTION SECRETIN-FERRING FERRING

75CU/VIAL

N018290

001

SECRETIN SYNTHETIC PORCINE

FOR SOLUTION; INTRAVENOUS SECREFLO CHIRHOCLIN 16MCG/VIAL

N021136

001

Apr 04, 2002

SELEGILINE HYDROCHLORIDE
CAPSULE; ORAL SELEGILINE HYDROCHLORIDE AAIPHARMA LLC 5MG TABLET; ORAL SELEGILINE HYDROCHLORIDE ENDO PHARMS 5MG IVAX SUB TEVA PHARMS 5MG SIEGFRIED 5MG SOMERSET 5MG TEVA 5MG 5MG

A075145

001

Sep 15, 2003

A074565 A074756 A074672 N019334 A074537 A074744

001 001 001 001 001 001

Aug Nov Apr Jun Aug Jan

02, 25, 01, 05, 02, 27,

1996 1998 1997 1989 1996 1997

SELENIUM SULFIDE
LOTION/SHAMPOO; TOPICAL EXSEL ALLERGAN HERBERT SELENIUM SULFIDE ACTAVIS MID ATLANTIC IVAX PHARMS TARO

2.5% 2.5% 2.5% 2.5%

A083892 A084394 A085777 A086209

001 001 001 001

SELENOMETHIONINE SE-75
INJECTABLE; INJECTION SELENOMETHIONINE SE 75 GE HEALTHCARE MALLINCKRODT PHARMALUCENCE SETHOTOPE BRACCO

250uCi/ML 100uCi/ML 500uCi/ML 85-550uCi/ML

N017257 N017098 N017322 N017047

001 001 001 001

SERACTIDE ACETATE
INJECTABLE; INJECTION ACTHAR GEL-SYNTHETIC ARMOUR PHARM

40 UNITS/ML 80 UNITS/ML

N017861 N017861

001 002

SERMORELIN ACETATE
INJECTABLE; INJECTION GEREF EMD SERONO

EQ 0.05MG BASE/AMP EQ 0.5MG BASE/VIAL EQ 1MG BASE/VIAL

N019863 N020443 N020443

001 001 002

Dec 28, 1990 Sep 26, 1997 Sep 26, 1997

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

SERTRALINE HYDROCHLORIDE
CONCENTRATE; ORAL SERTRALINE HYDROCHLORIDE ROXANE EQ TABLET; ORAL SERTRALINE HYDROCHLORIDE ACTAVIS ELIZABETH EQ EQ EQ ACTAVIS TOTOWA EQ EQ EQ IVAX SUB TEVA PHARMS EQ EQ EQ MUTUAL PHARM EQ EQ EQ PLIVA HRVATSKA DOO EQ EQ EQ ROXANE EQ EQ EQ SANDOZ EQ EQ EQ WATSON LABS EQ EQ EQ ZOLOFT PFIZER EQ EQ

6 - 299 (of 346)

20MG BASE/ML

A076934

001

Jun 30, 2006

25MG BASE 50MG BASE 100MG BASE 25MG BASE 50MG BASE 100MG BASE 25MG BASE 50MG BASE 100MG BASE 25MG BASE 50MG BASE 100MG BASE 25MG BASE 50MG BASE 100MG BASE 25MG BASE 50MG BASE 100MG BASE 25MG BASE 50MG BASE 100MG BASE 25MG BASE 50MG BASE 100MG BASE 150MG BASE 200MG BASE

A077345 A077345 A077345 A078175 A078175 A078175 A075719 A075719 A075719 A077818 A077818 A077818 A077299 A077299 A077299 A076881 A076881 A076881 A077713 A077713 A077713 A077162 A077162 A077162 N019839 N019839

001 002 003 001 002 003 003 001 002 001 002 003 001 002 003 001 002 003 001 002 003 001 002 003 003 004

Feb Feb Feb Jul Jul Jul Jun Jun Jun Feb Feb Feb Feb Feb Feb Feb Feb Feb Feb Feb Feb Feb Feb Feb

06, 06, 06, 21, 21, 21, 30, 30, 30, 06, 06, 06, 06, 06, 06, 06, 06, 06, 06, 06, 06, 06, 06, 06,

2007 2007 2007 2010 2010 2010 2006 2006 2006 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007

Dec 30, 1991 Dec 30, 1991

SEVELAMER HYDROCHLORIDE
CAPSULE; ORAL RENAGEL GENZYME

403MG

N020926

001

Oct 30, 1998

SIBUTRAMINE HYDROCHLORIDE
CAPSULE; ORAL MERIDIA ABBOTT

5MG 10MG 15MG

N020632 N020632 N020632

001 002 003

Nov 22, 1997 Nov 22, 1997 Nov 22, 1997

SILVER SULFADIAZINE
DRESSING; TOPICAL SILDAFLO FRANKLIN PHARMS

1%

N019608

001

Nov 30, 1989

SIMETHICONE-CELLULOSE
SUSPENSION; ORAL SONORX BRACCO

7.5MG/ML

N020773

001

Oct 29, 1998

SIMVASTATIN
TABLET; ORAL SIMVASTATIN ACTAVIS TOTOWA

5MG 10MG 20MG 40MG

A078735 A078735 A078735 A078735

001 002 003 004

Aug Aug Aug Aug

30, 30, 30, 30,

2010 2010 2010 2010

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

SIMVASTATIN
TABLET; ORAL SIMVASTATIN ACTAVIS TOTOWA SANDOZ INC

6 - 300 (of 346)

80MG 5MG 10MG 20MG 40MG 80MG TABLET, ORALLY DISINTEGRATING; ORAL SIMVASTATIN SYNTHON PHARMS 10MG 20MG 40MG 80MG

A078735 A077766 A077766 A077766 A077766 A077766

005 001 002 003 004 005

Aug Dec Dec Dec Dec Dec

30, 20, 20, 20, 20, 20,

2010 2006 2006 2006 2006 2006

N021961 N021961 N021961 N021961

001 002 003 004

Oct Oct Oct Oct

09, 09, 09, 09,

2007 2007 2007 2007

SIROLIMUS
TABLET; ORAL RAPAMUNE WYETH PHARMS INC

5MG

N021110

003

Feb 23, 2004

SODIUM BENZOATE; SODIUM PHENYLACETATE

SOLUTION; ORAL UCEPHAN B BRAUN

100MG/ML;100MG/ML

N019530

001

Dec 23, 1987

SODIUM BICARBONATE
INJECTABLE; INJECTION SODIUM BICARBONATE IN PLASTIC CONTAINER ABBOTT 0.9MEQ/ML 1MEQ/ML

N019443 N019443

001 002

Jun 03, 1986 Jun 03, 1986

SODIUM BICARBONATE; TARTARIC ACID

GRANULE, EFFERVESCENT; ORAL BAROS MALLINCKRODT LLC 460MG/GM;420MG/GM

N018509

001

Aug 07, 1985

SODIUM CHLORIDE
INJECTABLE; INJECTION BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER ABRAXIS PHARM 9MG/ML SODIUM CHLORIDE ABBOTT 20GM/100ML B BRAUN 20GM/100ML SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER B BRAUN 450MG/100ML MILES 450MG/100ML SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER ABBOTT 9MG/ML MILES 900MG/100ML SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER ABRAXIS PHARM 234MG/ML SODIUM CHLORIDE 3% IN PLASTIC CONTAINER B BRAUN 3GM/100ML SODIUM CHLORIDE 5% IN PLASTIC CONTAINER B BRAUN 5GM/100ML SOLUTION; IRRIGATION SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER BAXTER HLTHCARE 450MG/100ML HOSPIRA 450MG/100ML 450MG/100ML SODIUM CHLORIDE IN PLASTIC CONTAINER MILES 900MG/100ML

A088909 N017013 N017038 N018184 N018503 N019218 N018502 N019329 N019635 N019635

001 001 001 001 001 001 001 001 003 004

Feb 07, 1985

Jul 13, 1984

Apr 22, 1987 Mar 09, 1988 Mar 09, 1988

N018497 N017670 N018380 N018247

001 001 001 001

Feb 19, 1982

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

SODIUM CHROMATE CR-51
INJECTABLE; INJECTION CHROMITOPE SODIUM BRACCO SODIUM CHROMATE CR 51 MALLINCKRODT

6 - 301 (of 346)

2mCi/VIAL 100uCi/ML

N013993 N016708

002 001

SODIUM FLUORIDE F-18

INJECTABLE; INTRAVENOUS FLUORINE F-18 GE HEALTHCARE SODIUM FLUORIDE F 18 NIH NCI DCTD

2mCi/ML 10-200mCi/ML

N017042 N022494

001 001 Jan 26, 2011

SODIUM IODIDE I-123

CAPSULE; ORAL SODIUM IODIDE I 123 SYNCOR PHARMS

400uCi

N018671

003

May 27, 1982

SODIUM IODIDE I-131

CAPSULE; ORAL IODOTOPE BRACCO SODIUM IODIDE I 131 CIS MALLINCKRODT SOLUTION; ORAL IODOTOPE BRACCO SODIUM IODIDE I 131 CIS

1-130mCi 1-150mCi 50uCi 100uCi 0.8-100mCi 15-100uCi

N010929 N010929 N017316 N017316 N016515 N016517

001 003 001 002 002 002

7-106mCi/BOT 50mCi/ML

N010929 N017315

002 001

SODIUM LACTATE
INJECTABLE; INJECTION SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER B BRAUN 1.87GM/100ML HOSPIRA 1.87GM/100ML

N018186 N018249

001 001

SODIUM MONOFLUOROPHOSPHATE
GEL; DENTAL EXTRA-STRENGTH AIM CHESEBROUGH PONDS PASTE; DENTAL EXTRA-STRENGTH AIM CHESEBROUGH PONDS

1.2%

N019518

002

Aug 06, 1986

1.2%

N019518

001

Jun 03, 1987

SODIUM NITROPRUSSIDE
INJECTABLE; INJECTION NIPRIDE ROCHE NITROPRESS ABBOTT HOSPIRA SODIUM NITROPRUSSIDE ABRAXIS PHARM BAXTER HLTHCARE TEVA PARENTERAL

50MG/VIAL 50MG/VIAL 50MG/VIAL 50MG/VIAL 50MG/VIAL 50MG/VIAL 25MG/ML

N017546 A071555 N018450 A070566 A070031 N018581 A073465

001 001 001 001 001 001 001 Nov 16, 1987 Jun 09, 1986 Jan 17, 1985 Jul 28, 1982 Mar 30, 1992

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

SODIUM PHOSPHATE P-32
SOLUTION; INJECTION, ORAL PHOSPHOTOPE BRACCO 1-8mCi/VIAL SODIUM PHOSPHATE P 32 MALLINCKRODT 0.67mCi/ML 1.5mCi/VIAL

6 - 302 (of 346)

N010927 N011777 N011777

001 001 002

SODIUM POLYSTYRENE SULFONATE

POWDER; ORAL, RECTAL SODIUM POLYSTYRENE SULFONATE WOCKHARDT 453.6GM/BOT SUSPENSION; ORAL, RECTAL SODIUM POLYSTYRENE SULFONATE MORTON GROVE 15GM/60ML ROXANE 15GM/60ML

A088786

001

Sep 11, 1984

A088717 A088453

001 001

Sep 11, 1984 Nov 17, 1983

SODIUM SUCCINATE
INJECTABLE; INJECTION SODIUM SUCCINATE ELKINS SINN

30%

A080516

001

SODIUM TETRADECYL SULFATE

INJECTABLE; INJECTION SOTRADECOL ELKINS SINN

1% 3%

N005970 N005970

004 005

SODIUM THIOSULFATE
INJECTABLE; INJECTION SODIUM THIOSULFATE US ARMY

250MG/ML

N020166

001

Feb 14, 1992

SOMATREM
INJECTABLE; INJECTION PROTROPIN GENENTECH

5MG/VIAL 10MG/VIAL

N019107 N019107

001 002

Oct 17, 1985 Oct 24, 1989

SOMATROPIN
INJECTABLE; INJECTION ASELLACRIN 10 SERONO ASELLACRIN 2 SERONO CRESCORMON GENENTECH

10 IU/VIAL 2 IU/VIAL 4 IU/VIAL

N017726 N017726 N017992

001 002 001 Jul 21, 1983

SOMATROPIN RECOMBINANT
INJECTABLE; INJECTION ACCRETROPIN CANGENE BIO-TROPIN FERRING HUMATROPE LILLY NORDITROPIN NOVO NORDISK INC NUTROPIN DEPOT GENENTECH

5MG/ML (5MG/ML) 4.8MG/VIAL 2MG/VIAL 4MG/VIAL 8MG/VIAL 13.5MG/VIAL 18MG/VIAL 22.5MG/VIAL

N021538 N019774 N019640 N019721 N019721 N021075 N021075 N021075

001 001 001 001 002 001 002 003

Jan 23, 2008 May 25, 1995 Jun 23, 1987 May 08, 1995 May 08, 1995 Dec 22, 1999 Dec 22, 1999 Dec 22, 1999

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

SOMATROPIN RECOMBINANT
INJECTABLE; INJECTION SAIZEN EMD SERONO SEROSTIM EMD SERONO ZORBTIVE EMD SERONO

6 - 303 (of 346)

4MG/VIAL 6MG/VIAL 8.8MG/VIAL 4MG/VIAL 5MG/VIAL 6MG/VIAL

N019764 N019764 N020604 N021597 N021597 N021597

005 001 004 001 002 003

Jan 16, 2007 Oct 08, 1996 Sep 06, 2001 Dec 01, 2003 Dec 01, 2003 Dec 01, 2003

INJECTABLE; SUBCUTANEOUS SEROSTIM LQ EMD SERONO

6MG/0.5ML (6MG/0.5ML)

N020604

005

Feb 11, 2005

SORBITOL
SOLUTION; IRRIGATION SORBITOL 3% IN PLASTIC CONTAINER BAXTER HLTHCARE 3GM/100ML

N018512

001

May 27, 1982

SOTALOL HYDROCHLORIDE
TABLET; ORAL BETAPACE BAYER HLTHCARE BETAPACE AF BAYER HLTHCARE

320MG 40MG 60MG 100MG 80MG 80MG 120MG 120MG 160MG 160MG 240MG 80MG 120MG 160MG 240MG

N019865 N021151 N021151 N021151 A075515 A076576 A075515 A076576 A075515 A076576 A075515 A075238 A075238 A075238 A075238

004 006 007 005 001 001 004 002 002 003 003 001 002 003 004

Oct 30, 1992 Apr 02, 2003 Apr 02, 2003 Mar 14, 2003 Oct Apr Oct Apr Oct Apr Oct Jul Jul Jul Jul 15, 08, 15, 08, 15, 08, 15, 13, 13, 13, 13, 2001 2004 2001 2004 2001 2004 2001 2000 2000 2000 2000

SOTALOL HYDROCHLORIDE MUTUAL PHARM

WATSON LABS

SOYBEAN OIL
INJECTABLE; INJECTION SOYACAL 10% ALPHA THERA SOYACAL 20% ALPHA THERA TRAVAMULSION 10% BAXTER HLTHCARE TRAVAMULSION 20% BAXTER HLTHCARE

10% 20% 10% 20%

N018465 N018786 N018660 N018758

001 001 001 001

Jun 29, 1983 Jun 29, 1983 Feb 26, 1982 Feb 15, 1983

SPARFLOXACIN
TABLET; ORAL ZAGAM MYLAN

200MG

N020677

001

Dec 19, 1996

SPECTINOMYCIN HYDROCHLORIDE
INJECTABLE; INJECTION TROBICIN PFIZER

EQ 2GM BASE/VIAL EQ 4GM BASE/VIAL

N050347 N050347

001 002

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DISCONTINUED DRUG PRODUCT LIST

SPIRAPRIL HYDROCHLORIDE
TABLET; ORAL RENORMAX SCHERING

6 - 304 (of 346)

3MG 6MG 12MG 24MG

N020240 N020240 N020240 N020240

001 002 003 004

Dec Dec Dec Dec

29, 29, 29, 29,

1994 1994 1994 1994

SPIRONOLACTONE
TABLET; ORAL SPIRONOLACTONE ASCOT IVAX PHARMS LEDERLE MUTUAL PHARM MYLAN PUREPAC PHARM SUPERPHARM UPSHER SMITH VANGARD WARNER CHILCOTT WATSON LABS

25MG 25MG 25MG 25MG 25MG 25MG 25MG 25MG 25MG 25MG 25MG 25MG 25MG

A087687 A087108 A087634 A087265 A087086 A087998 A088053 A089364 A087554 A087648 A087952 A086898 A087078

001 001 001 001 001 001 001 001 001 001 001 002 001

Oct 20, 1982

Oct 14, 1983 Aug 25, 1983 Nov 07, 1986 Feb 01, 1982 Nov 18, 1982 Mar 02, 1982

STANOZOLOL
TABLET; ORAL WINSTROL LUNDBECK INC

2MG

N012885

001

May 14, 1984

STAVUDINE
CAPSULE; ORAL ZERIT BRISTOL MYERS SQUIBB 5MG CAPSULE, EXTENDED RELEASE; ORAL ZERIT XR BRISTOL MYERS SQUIBB 37.5MG 50MG 75MG 100MG

N020412

001

Jun 24, 1994

N021453 N021453 N021453 N021453

001 002 003 004

Dec Dec Dec Dec

31, 31, 31, 31,

2002 2002 2002 2002

STERILE WATER FOR INJECTION

LIQUID; N/A BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER ABRAXIS PHARM 100% 100% STERILE WATER FOR INJECTION IN PLASTIC CONTAINER B BRAUN 100%

A089099 A089100 N019077

001 001 001

Dec 29, 1987 Dec 29, 1987 Mar 02, 1984

STERILE WATER FOR IRRIGATION

LIQUID; IRRIGATION STERILE WATER IN PLASTIC CONTAINER MILES 100%

N018246

001

STREPTOMYCIN SULFATE
INJECTABLE; INJECTION STREPTOMYCIN SULFATE COPANOS LILLY

PFIZER

EQ EQ EQ EQ EQ EQ

500MG BASE/ML 1GM BASE/VIAL 1GM BASE/2ML 5GM BASE/VIAL 1GM BASE/VIAL 1GM BASE/2.5ML

A060684 A060107 A060404 A060107 A060076 A060111

001 001 001 002 001 001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

STREPTOMYCIN SULFATE
INJECTABLE; INJECTION STREPTOMYCIN SULFATE PFIZER

6 - 305 (of 346)

EQ 5GM BASE/VIAL

A060076

002

SUCCINYLCHOLINE CHLORIDE
INJECTABLE; INJECTION ANECTINE SANDOZ

50MG/ML 500MG/VIAL 1GM/VIAL QUELICIN PRESERVATIVE FREE HOSPIRA 50MG/ML SUCCINYLCHOLINE CHLORIDE INTL MEDICATION 100MG/VIAL ORGANON USA INC 20MG/ML SUCOSTRIN APOTHECON 20MG/ML 100MG/ML

N008453 N008453 N008453 N008845 A085400 A080997 N008847 N008847

003 001 004 002 001 001 001 003 Feb 04, 1982

SUFENTANIL CITRATE
INJECTABLE; INJECTION SUFENTANIL CITRATE WATSON LABS

EQ 0.05MG BASE/ML

A074406

001

Dec 15, 1995

SULFACETAMIDE SODIUM
OINTMENT; OPHTHALMIC BLEPH-10 ALLERGAN 10% SODIUM SULAMYD SCHERING 10% SULFAIR 10 PHARMAFAIR 10% SOLUTION/DROPS; OPHTHALMIC BLEPH-30 ALLERGAN 30% ISOPTO CETAMIDE ALCON 15% OCUSULF-10 MIZA PHARMS USA 10% OCUSULF-30 MIZA PHARMS USA 30% SODIUM SULAMYD SCHERING 10% 30% SODIUM SULFACETAMIDE AKORN 10% 15% 30% SOLA BARNES HIND 10% 10% 30% 30% SULF-10 NOVARTIS 10% SULF-15 NOVARTIS 15% SULFACEL-15 OPTOPICS 15% SULFACETAMIDE SODIUM AKORN 10% 30% ALCON PHARMS LTD 30%

A084015 N005963 A088000

001 002 001 Dec 22, 1982

A080028 A080020 A080660 A080660 N005963 N005963 A083021 A083021 A083021 A084143 A084145 A084146 A084147 A080025 A089047 A080024 A040215 A040216 A089068

002 002 001 002 001 003 001 002 003 001 001 001 001 001 001 001 001 001 001 May 25, 1999 May 25, 1999 May 05, 1987 Oct 31, 1995

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

SULFACETAMIDE SODIUM
SOLUTION/DROPS; OPHTHALMIC SULFACETAMIDE SODIUM 10% PHARMAFAIR SULFAIR 10 10% PHARMAFAIR SULFAIR FORTE 30% PHARMAFAIR SULFAIR-15 15% PHARMAFAIR SULTEN-10 10% BAUSCH AND LOMB

6 - 306 (of 346)

A088947 A087949 A088385 A088186 A087818

001 001 001 001 001

May 17, 1985 Dec 13, 1982 Oct 13, 1983 May 25, 1983 Feb 03, 1983

SULFACYTINE
TABLET; ORAL RENOQUID GLENWOOD

250MG

N017569

001

SULFADIAZINE
TABLET; ORAL SULFADIAZINE ABBOTT EVERYLIFE IMPAX LABS LANNETT LEDERLE LILLY

300MG 500MG 500MG 500MG 500MG 500MG

N004125 A080088 A080081 A080084 N004054 N004122

005 001 001 001 001 002

SULFADIAZINE SODIUM
INJECTABLE; INJECTION SULFADIAZINE SODIUM LEDERLE

250MG/ML

N004054

002

SULFADIAZINE; SULFAMERAZINE
SUSPENSION; ORAL SULFONAMIDES DUPLEX LILLY

250MG/5ML;250MG/5ML

N006317

007

SULFAMETER
TABLET; ORAL SULLA BAYER HLTHCARE

500MG

N016000

002

SULFAMETHIZOLE
TABLET; ORAL MICROSUL FOREST PHARMS PROKLAR FOREST PHARMS THIOSULFIL WYETH AYERST

1GM 500MG 250MG 500MG

A086012 A080273 N008565 N008565

001 001 001 004

SULFAMETHOXAZOLE
SUSPENSION; ORAL GANTANOL ROCHE TABLET; ORAL GANTANOL ROCHE GANTANOL-DS ROCHE

500MG/5ML

N013664

002

500MG 1GM

N012715 N012715

002 003

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

SULFAMETHOXAZOLE
TABLET; ORAL SULFAMETHOXAZOLE ASCOT BARR HEATHER SANDOZ WATSON LABS UROBAK SHIONOGI

6 - 307 (of 346)

500MG 500MG 500MG 500MG 500MG 1GM 500MG

A087662 A087189 A086163 A085844 A085053 A086000 A087307

001 001 001 001 001 001 001

Oct 20, 1982 Jul 25, 1983

SULFAMETHOXAZOLE; TRIMETHOPRIM
INJECTABLE; INJECTION BACTRIM MUTUAL PHARM 80MG/ML;16MG/ML SEPTRA MONARCH PHARMS 80MG/ML;16MG/ML SULFAMETHOXAZOLE AND TRIMETHOPRIM ABRAXIS PHARM 80MG/ML;16MG/ML BAXTER HLTHCARE 80MG/ML;16MG/ML 80MG/ML;16MG/ML BEDFORD 80MG/ML;16MG/ML HOSPIRA 80MG/ML;16MG/ML WATSON LABS 80MG/ML;16MG/ML SUSPENSION; ORAL BACTRIM MUTUAL PHARM 200MG/5ML;40MG/5ML BACTRIM PEDIATRIC MUTUAL PHARM 200MG/5ML;40MG/5ML SEPTRA MONARCH PHARMS 200MG/5ML;40MG/5ML SEPTRA GRAPE MONARCH PHARMS 200MG/5ML;40MG/5ML SULFAMETHOXAZOLE AND TRIMETHOPRIM TEVA 200MG/5ML;40MG/5ML 200MG/5ML;40MG/5ML 200MG/5ML;40MG/5ML TEVA PHARMS 200MG/5ML;40MG/5ML SULFATRIM ACTAVIS MID ATLANTIC 200MG/5ML;40MG/5ML SULMEPRIM USL PHARMA 200MG/5ML;40MG/5ML SULMEPRIM PEDIATRIC USL PHARMA 200MG/5ML;40MG/5ML TRIMETH/SULFA ALPHARMA US PHARMS 200MG/5ML;40MG/5ML 200MG/5ML;40MG/5ML NASKA 200MG/5ML;40MG/5ML TABLET; ORAL COTRIM TEVA 400MG;80MG COTRIM D.S. TEVA 800MG;160MG SULFAMETHOXAZOLE AND TRIMETHOPRIM HEATHER 400MG;80MG 800MG;160MG INTERPHARM 400MG;80MG 800MG;160MG MARTEC USA LLC 400MG;80MG MUTUAL PHARM 400MG;80MG 400MG;80MG PLIVA 400MG;80MG

N018374 N018452 A070223 A070627 A070628 A072383 A073199 A071556

001 001 001 001 001 001 001 001 Dec Dec Dec Apr Sep Dec 29, 29, 29, 29, 11, 29, 1987 1987 1987 1992 1992 1987

N017560 N017560 N017598 N017598 A070028 N018812 N018812 A077612 N018615 A070063 A070064 A072289 A072398 A072399

001 002 001 002 001 001 002 001 002 001 001 001 001 001 Feb 12, 1986 Jun Jan Jun Nov 02, 28, 10, 13, 1987 1983 1983 2006

Jan 07, 1983 Aug 01, 1986 Aug 01, 1986 May 23, 1988 May 23, 1988 May 23, 1988

A070034 A070048 N018946 N018946 A071299 A071300 A072408 A070006 A071016 A070215

001 001 001 002 001 001 001 001 001 001

May 16, 1985 Mar 18, 1985 Aug Aug Oct Oct Dec Nov Aug Sep 10, 10, 27, 27, 07, 14, 25, 10, 1984 1984 1987 1987 1988 1984 1986 1985

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

SULFAMETHOXAZOLE; TRIMETHOPRIM
TABLET; ORAL SULFAMETHOXAZOLE AND TRIMETHOPRIM PLIVA 800MG;160MG ROXANE 400MG;80MG SANDOZ 400MG;80MG 400MG;80MG 800MG;160MG TEVA 400MG;80MG 800MG;160MG USL PHARMA 400MG;80MG 800MG;160MG WATSON LABS 400MG;80MG 400MG;80MG 800MG;160MG SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH MARTEC USA LLC 800MG;160MG MUTUAL PHARM 800MG;160MG ROXANE 800MG;160MG WATSON LABS 800MG;160MG SULFATRIM-DS SUPERPHARM 800MG;160MG SULFATRIM-SS SUPERPHARM 400MG;80MG UROPLUS DS SHIONOGI 800MG;160MG UROPLUS SS SHIONOGI 400MG;80MG

6 - 308 (of 346)

A070216 A072768 A070889 N018598 A070890 N018242 N018242 A070203 A070204 A070002 N018852 A070000 A072417 A070007 A072769 N018854 A070066 A070065 A071816 A071815

001 001 001 003 001 001 002 001 001 001 001 001 001 001 001 001 001 002 001 001

Sep Aug Nov May Nov

10, 30, 13, 19, 13,

1985 1991 1986 1982 1986

Nov Nov Nov May Nov Dec Nov Aug May

08, 08, 07, 09, 07, 07, 14, 30, 09,

1985 1985 1984 1983 1984 1988 1984 1991 1983

Jun 24, 1985 Jun 24, 1985 Sep 28, 1987 Sep 28, 1987

SULFANILAMIDE
CREAM; VAGINAL SULFANILAMIDE TEVA SUPPOSITORY; VAGINAL AVC AZUR PHARMA

15%

A088718

001

Sep 19, 1985

1.05GM

N006530

004

Jan 27, 1987

SULFAPHENAZOLE
SUSPENSION; ORAL SULFABID PHARM RES ASSOC TABLET; ORAL SULFABID PURDUE FREDERICK

500MG/5ML

N013093

001

500MG

N013092

002

SULFAPYRIDINE
TABLET; ORAL SULFAPYRIDINE LILLY

500MG

N000159

001

SULFASALAZINE
SUSPENSION; ORAL AZULFIDINE PHARMACIA AND UPJOHN TABLET; ORAL S.A.S.-500 SOLVAY SULFASALAZINE HERITAGE PHARMS INC MUTUAL PHARM SANDOZ SUPERPHARM WATSON LABS

250MG/5ML

N018605

001

500MG 500MG 500MG 500MG 500MG 500MG

A083450 A080197 A089590 A086184 A089339 A084964

001 001 001 001 001 001

Oct 19, 1987 Oct 26, 1987

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SULFASALAZINE
TABLET, DELAYED RELEASE; ORAL SULFASALAZINE 500MG WATSON LABS

6 - 309 (of 346)

A088052

001

May 24, 1983

SULFINPYRAZONE
CAPSULE; ORAL ANTURANE NOVARTIS SULFINPYRAZONE BARR IVAX PHARMS PAR PHARM VANGARD TABLET; ORAL ANTURANE NOVARTIS SULFINPYRAZONE BARR IVAX PHARMS PAR PHARM WATSON LABS

200MG 200MG 200MG 200MG 200MG

N011556 A087666 A087770 A088934 A088666

004 001 001 001 001 Sep Nov Sep Feb 17, 19, 06, 17, 1982 1982 1985 1984

100MG 100MG 100MG 100MG 100MG

N011556 A087665 A087769 A088933 A087667

003 001 001 001 001 Sep Jun Sep May 17, 01, 06, 26, 1982 1982 1985 1982

SULFISOXAZOLE
TABLET; ORAL GANTRISIN ROCHE SOSOL MK LABS SOXAZOLE ALRA SULFALAR PARKE DAVIS SULFISOXAZOLE BARR HEATHER IMPAX LABS IVAX SUB TEVA PHARMS LANNETT LEDERLE PHARMERAL PUREPAC PHARM ROXANE SANDOZ VALEANT PHARM INTL VITARINE WATSON LABS WEST WARD SULSOXIN SOLVAY

500MG 500MG 500MG 500MG 500MG 500MG 500MG 500MG 500MG 500MG 500MG 500MG 500MG 500MG 500MG 500MG 500MG 500MG 500MG

N006525 A080036 A080366 A084955 A084031 A080189 A080109 A080142 A080085 A087649 A084385 A080087 A080082 A085628 A080268 A087332 A085534 A080379 A080040

001 001 001 001 001 001 001 001 001 001 001 001 001 001 002 001 001 001 001

SULFISOXAZOLE ACETYL
EMULSION; ORAL LIPO GANTRISIN ROCHE SUSPENSION; ORAL GANTRISIN PEDIATRIC ROCHE SYRUP; ORAL GANTRISIN ROCHE

EQ 1GM BASE/5ML

N009182

009

EQ 500MG BASE/5ML

N009182

004

EQ 500MG BASE/5ML

N009182

002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

SULFISOXAZOLE DIOLAMINE
INJECTABLE; INJECTION GANTRISIN ROCHE EQ OINTMENT; OPHTHALMIC GANTRISIN ROCHE EQ SOLUTION/DROPS; OPHTHALMIC GANTRISIN ROCHE EQ SULFISOXAZOLE DIOLAMINE SOLA BARNES HIND EQ

6 - 310 (of 346)

400MG BASE/ML

N006917

001

4% BASE

N008414

002

4% BASE 4% BASE

N007757 A084148

002 001

SULFOXONE SODIUM
TABLET, DELAYED RELEASE; ORAL DIASONE SODIUM ABBOTT 165MG

N006044

003

SULFUR
POWDER; TOPICAL BENSULFOID POYTHRESS

33.32%

N002918

001

SULINDAC
TABLET; ORAL CLINORIL MERCK SULINDAC HERITAGE PHARMS INC SANDOZ TEVA

150MG 150MG 200MG 150MG 200MG 150MG 200MG

N017911 A073262 A073262 A072712 A072713 A072972 A072973

001 002 001 001 001 001 001 Sep Sep Aug Aug Feb Feb 06, 06, 30, 30, 28, 28, 1991 1991 1991 1991 1992 1992

SUMATRIPTAN
SPRAY; NASAL IMITREX GLAXOSMITHKLINE

10MG/SPRAY

N020626

002

Aug 26, 1997

SUMATRIPTAN SUCCINATE
INJECTABLE; SUBCUTANEOUS SUMATRIPTAN SUCCINATE TEVA PARENTERAL TABLET; ORAL SUMATRIPTAN SUCCINATE ROXANE

EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)

A078318 A078318

001 002

Feb 06, 2009 Feb 06, 2009

EQ 25MG BASE EQ 50MG BASE EQ 100MG BASE

A078241 A078241 A078241

001 002 003

Aug 10, 2009 Aug 10, 2009 Aug 10, 2009

SUPROFEN
SOLUTION/DROPS; OPHTHALMIC PROFENAL ALCON 1%

N019387

001

Dec 23, 1988

SUTILAINS
OINTMENT; TOPICAL TRAVASE ABBOTT

82,000 UNITS/GM

N012828

001

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DISCONTINUED DRUG PRODUCT LIST

TACRINE HYDROCHLORIDE
CAPSULE; ORAL COGNEX SHIONOGI INC

6 - 311 (of 346)

EQ EQ EQ EQ

10MG 20MG 30MG 40MG

BASE BASE BASE BASE

N020070 N020070 N020070 N020070

001 002 003 004

Sep Sep Sep Sep

09, 09, 09, 09,

1993 1993 1993 1993

TALBUTAL
TABLET; ORAL LOTUSATE SANOFI AVENTIS US

120MG

N009410

005

TAMOXIFEN CITRATE
SOLUTION; ORAL SOLTAMOX ROSEMONT TABLET; ORAL NOLVADEX ASTRAZENECA TAMOXIFEN CITRATE IVAX SUB TEVA PHARMS PHARMACHEMIE ROXANE TEVA

EQ 10MG BASE/5ML

N021807

001

Oct 29, 2005

EQ 10MG BASE EQ 20MG BASE EQ EQ EQ EQ EQ EQ EQ 10MG 20MG 10MG 10MG 20MG 10MG 20MG BASE BASE BASE BASE BASE BASE BASE

N017970 N017970 A075740 A075740 A074539 A076027 A076027 A074504 A074504

001 002 001 002 001 001 002 001 002

Mar 21, 1994 Feb Feb Mar Feb Feb Apr Apr 20, 20, 31, 20, 20, 28, 28, 2003 2003 2003 2003 2003 2003 2003

TECHNETIUM TC-99M ALBUMIN AGGREGATED

INJECTABLE; INJECTION TC 99M-LUNGAGGREGATE GE HEALTHCARE

5mCi/ML

N017848

001

TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT

INJECTABLE; INJECTION A-N STANNOUS AGGREGATED SYNCOR PHARMS AN-MAA PHARMALUCENCE LUNGAGGREGATE REAGENT GE HEALTHCARE MACROTEC BRACCO TECHNESCAN MAA MALLINCKRODT TECHNETIUM TC 99M MAA GE HEALTHCARE ALBUMIN N/A N/A N/A N/A N/A N/A

N017916 N017792 N017838 N017833 N017842 N017773

001 001 001 001 001 001

TECHNETIUM TC-99M ALBUMIN COLLOID KIT

INJECTABLE; INJECTION MICROLITE PHARMALUCENCE

N/A

N018263

001

Mar 25, 1983

TECHNETIUM TC-99M ALBUMIN KIT

INJECTABLE; INJECTION TECHNETIUM TC 99M HSA GE HEALTHCARE

N/A

N017775

001

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DISCONTINUED DRUG PRODUCT LIST

TECHNETIUM TC-99M ALBUMIN MICROSPHERES KIT
INJECTABLE; INJECTION INSTANT MICROSPHERES 3M

6 - 312 (of 346)

N/A

N017832

001

TECHNETIUM TC-99M APCITIDE

INJECTABLE; INJECTION ACUTECT CIS BIO INTL SA

N/A

N020887

001

Sep 14, 1998

TECHNETIUM TC-99M DEPREOTIDE

INJECTABLE; INJECTION NEO TECT KIT CIS BIO INTL SA

N/A

N021012

001

Aug 03, 1999

TECHNETIUM TC-99M ETIDRONATE KIT

INJECTABLE; INJECTION CINTICHEM TECHNETIUM 99M HEDSPA GE HEALTHCARE N/A MPI STANNOUS DIPHOSPHONATE GE HEALTHCARE N/A OSTEOSCAN MALLINCKRODT N/A TECHNETIUM TC 99M DIPHOSPHONATE-TIN KIT GE HEALTHCARE N/A

N017653 N017667 N017454 N017562

001 001 001 001

TECHNETIUM TC-99M FERPENTETATE KIT

INJECTABLE; INJECTION RENOTEC BRACCO

N/A

N017045

001

TECHNETIUM TC-99M GLUCEPTATE KIT

INJECTABLE; INJECTION GLUCOSCAN BRISTOL MYERS SQUIBB TECHNESCAN GLUCEPTATE DRAXIMAGE

N/A N/A

N017907 N018272

001 001 Jan 27, 1982

TECHNETIUM TC-99M LIDOFENIN KIT

INJECTABLE; INJECTION TECHNESCAN HIDA DRAXIMAGE

N/A

N018489

001

Oct 31, 1986

TECHNETIUM TC-99M MEDRONATE

INJECTABLE; INJECTION DRAXIMAGE MDP-10 DRAXIMAGE

N/A

N018035

001

TECHNETIUM TC-99M MEDRONATE KIT

INJECTABLE; INJECTION AMERSCAN MDP KIT GE HEALTHCARE N/A OSTEOLITE PHARMALUCENCE N/A TECHNETIUM TC 99M MPI MDP GE HEALTHCARE N/A N/A

N018335 N017972 N018141 N018141

001 001 001 002

Aug 05, 1982

Jun 12, 1989

TECHNETIUM TC-99M PENTETATE KIT

INJECTABLE; INJECTION MPI DTPA KIT - CHELATE GE HEALTHCARE

N/A

N017255

001

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TECHNETIUM TC-99M PENTETATE KIT
INJECTABLE; INJECTION TECHNETIUM TC-99M PENTETATE KIT GE HEALTHCARE N/A

6 - 313 (of 346)

N017264

002

TECHNETIUM TC-99M POLYPHOSPHATE KIT

INJECTABLE; INJECTION SODIUM POLYPHOSPHATE-TIN KIT GE HEALTHCARE N/A

N017664

001

TECHNETIUM TC-99M PYRO/TRIMETA PHOSPHATES KIT

INJECTABLE; INJECTION PYROLITE PHARMALUCENCE

N/A

N017684

001

TECHNETIUM TC-99M PYROPHOSPHATE KIT

INJECTABLE; INJECTION PHOSPHOTEC BRACCO

N/A

N017680

001

TECHNETIUM TC-99M RED BLOOD CELL KIT

INJECTABLE; INJECTION RBC-SCAN CADEMA

N/A

N020063

001

Jun 11, 1992

TECHNETIUM TC-99M SESTAMIBI KIT

INJECTABLE; INJECTION MIRALUMA LANTHEUS MEDCL

N/A

N019785

003

May 23, 1997

TECHNETIUM TC-99M SODIUM PERTECHNETATE

SOLUTION; INJECTION, ORAL SODIUM PERTECHNETATE TC GE HEALTHCARE MALLINCKRODT PHARMALUCENCE 99M 2-100mCi/ML 10-60mCi/ML 12mCi/ML 24mCi/ML 48mCi/ML

N017471 N017725 N017321 N017321 N017321

001 001 001 002 003

TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR

SOLUTION; INJECTION, ORAL MINITEC BRACCO 0.22-2.22 CI/GENERATOR TECHNETIUM TC 99M GENERATOR GE HEALTHCARE 830-16600mCi/GENERATOR

N017339 N017693

001 001

TECHNETIUM TC-99M SULFUR COLLOID

SOLUTION; INJECTION, ORAL TECHNETIUM TC 99M SULFUR COLLOID GE HEALTHCARE 4mCi/ML SOLUTION; ORAL TECHNETIUM TC 99M SULFUR COLLOID MALLINCKRODT 3mCi/ML

N017456

001

N017724

001

TECHNETIUM TC-99M SULFUR COLLOID KIT

SOLUTION; INJECTION, ORAL TECHNECOLL MALLINCKRODT N/A TECHNETIUM TC 99M TSC GE HEALTHCARE N/A TESULOID BRACCO N/A

N017059 N017784 N016923

001 001 001

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TECHNETIUM TC-99M TEBOROXIME KIT
INJECTABLE; INJECTION CARDIOTEC BRACCO

6 - 314 (of 346)

N/A

N019928

001

Dec 19, 1990

TEGASEROD MALEATE
TABLET; ORAL ZELNORM NOVARTIS

EQ 2MG BASE EQ 6MG BASE

N021200 N021200

001 002

Jul 24, 2002 Jul 24, 2002

TELBIVUDINE
SOLUTION; ORAL TYZEKA NOVARTIS

100MG/5ML

N022154

001

Apr 28, 2009

TEMAZEPAM
CAPSULE; ORAL TEMAZ QUANTUM PHARMICS TEMAZEPAM DURAMED PHARMS BARR MUTUAL PHARM USL PHARMA WATSON LABS

15MG 30MG 15MG 30MG 15MG 30MG 15MG 30MG 15MG 30MG

A070564 A070547 A071708 A071709 A071174 A071175 A070489 A070490 A070383 A070384

001 001 001 001 001 001 001 001 001 001

Oct 15, 1985 Oct 15, 1985 Sep Sep Jul Jul Jul Jul Mar Mar 29, 29, 10, 10, 07, 07, 23, 23, 1988 1988 1986 1986 1986 1986 1987 1987

TERAZOSIN HYDROCHLORIDE
CAPSULE; ORAL TERAZOSIN HYDROCHLORIDE MYLAN TECHNOLOGIES EQ EQ EQ EQ SANDOZ EQ EQ EQ EQ TABLET; ORAL TERAZOSIN HYDROCHLORIDE IVAX SUB TEVA PHARMS EQ EQ EQ EQ SANDOZ EQ EQ EQ EQ EQ EQ EQ EQ TEVA EQ EQ EQ EQ

1MG BASE 2MG BASE 5MG BASE 10MG BASE 1MG BASE 2MG BASE 5MG BASE 10MG BASE

A075384 A075384 A075384 A075384 A075667 A075667 A075667 A075667

001 002 003 004 001 002 003 004

Dec Dec Dec Dec Jul Jul Jul Jul

01, 01, 01, 01, 28, 28, 28, 28,

2000 2000 2000 2000 2000 2000 2000 2000

1MG BASE 2MG BASE 5MG BASE 10MG BASE 1MG BASE 1MG BASE 2MG BASE 2MG BASE 5MG BASE 5MG BASE 10MG BASE 10MG BASE 1MG BASE 2MG BASE 5MG BASE 10MG BASE

A074530 A074530 A074530 A074530 A074315 A074657 A074315 A074657 A074315 A074657 A074315 A074657 A074446 A074446 A074446 A074446

001 002 003 004 001 001 002 002 003 003 004 004 001 002 003 004

Apr Apr Apr Apr Dec Apr Dec Apr Dec Apr Dec Apr May May May May

21, 21, 21, 21, 31, 28, 31, 28, 31, 28, 31, 28, 18, 18, 18, 18,

2000 2000 2000 2000 1998 2000 1998 2000 1998 2000 1998 2000 2000 2000 2000 2000

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TERBINAFINE
GEL; TOPICAL LAMISIL NOVARTIS

6 - 315 (of 346)

1%

N020846

001

Apr 29, 1998

TERBINAFINE HYDROCHLORIDE
CREAM; TOPICAL LAMISIL NOVARTIS 1% SOLUTION; TOPICAL LAMISIL NOVARTIS 1% TABLET; ORAL TERBINAFINE HYDROCHLORIDE GEDEON RICHTER USA EQ 250MG BASE ROXANE EQ 250MG BASE

N020192

001

Dec 30, 1992

N020749

001

Oct 17, 1997

A077065 A077223

001 001

Jul 02, 2007 Jul 02, 2007

TERBUTALINE SULFATE
AEROSOL, METERED; INHALATION BRETHAIRE NOVARTIS 0.2MG/INH BRICANYL SANOFI AVENTIS US 0.2MG/INH INJECTABLE; INJECTION BRETHINE AAIPHARMA LLC 1MG/ML BRICANYL SANOFI AVENTIS US 1MG/ML TABLET; ORAL BRETHINE LEHIGH VALLEY 2.5MG 5MG BRICANYL SANOFI AVENTIS US 2.5MG 5MG

N018762 N018000

001 001

Aug 17, 1984 Mar 19, 1985

N018571 N017466

001 001

N017849 N017849 N017618 N017618

001 002 001 002

TERIPARATIDE ACETATE
INJECTABLE; INJECTION PARATHAR SANOFI AVENTIS US

200 UNITS/VIAL

N019498

001

Dec 23, 1987

TERIPARATIDE RECOMBINANT HUMAN

INJECTABLE; SUBCUTANEOUS FORTEO LILLY

0.75MG/3ML (0.25MG/ML)

N021318

001

Nov 26, 2002

TESTOLACTONE
INJECTABLE; INJECTION TESLAC BRISTOL MYERS SQUIBB TABLET; ORAL TESLAC BRISTOL MYERS SQUIBB

100MG/ML

N016119

001

50MG 250MG

N016118 N016118

001 002

TESTOSTERONE
FILM, EXTENDED RELEASE; TRANSDERMAL ANDRODERM WATSON LABS 2.5MG/24HR 5MG/24HR TESTODERM ALZA 4MG/24HR 6MG/24HR

N020489 N020489 N019762 N019762

001 002 001 002

Sep 29, 1995 May 02, 1997 Oct 12, 1993 Oct 12, 1993

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TESTOSTERONE
FILM, EXTENDED RELEASE; TRANSDERMAL TESTODERM TTS ALZA 5MG/24HR GEL; TRANSDERMAL TESTOSTERONE PAR PHARM 1% (2.5GM/PACKET) 1% (5GM/PACKET) WATSON LABS 1% (2.5GM/PACKET) 1% (5GM/PACKET) INJECTABLE; INJECTION TESTOSTERONE WATSON LABS 25MG/ML 50MG/ML 100MG/ML

6 - 316 (of 346)

N020791

001

Dec 18, 1997

A076744 A076744 A076737 A076737

001 002 001 002

May May Jan Jan

23, 23, 27, 27,

2007 2007 2006 2006

A086420 A086419 A086417

001 001 001

May 10, 1983 Aug 23, 1983 Jul 07, 1983

TESTOSTERONE CYPIONATE
INJECTABLE; INJECTION DEPO-TESTOSTERONE PHARMACIA AND UPJOHN TESTOSTERONE CYPIONATE WATSON LABS

50MG/ML 100MG/ML 100MG/ML 200MG/ML

A085635 A084401 A086029 A084401

001 001 001 002

TESTOSTERONE ENANTHATE
INJECTABLE; INJECTION DELATESTRYL ENDO PHARM TESTOSTERONE ENANTHATE WATSON LABS

200MG/ML 100MG/ML 100MG/ML 200MG/ML

N009165 A083667 A085599 A083667

001 001 001 002

TESTOSTERONE PROPIONATE
INJECTABLE; INJECTION TESTOSTERONE PROPIONATE BEL MAR 25MG/ML 50MG/ML 100MG/ML ELKINS SINN 25MG/ML LILLY 50MG/ML WATSON LABS 25MG/ML 25MG/ML 50MG/ML 50MG/ML 100MG/ML 100MG/ML

A080741 A080742 A080743 A080276 A080254 A080188 A085490 A080188 A085490 A080188 A083595

001 001 001 001 002 001 001 002 002 003 003

TETRACYCLINE HYDROCHLORIDE
CAPSULE; ORAL ACHROMYCIN V HERITAGE PHARMS INC BRISTACYCLINE BRISTOL

250MG 500MG 250MG 250MG 500MG 500MG 250MG 250MG 250MG

N050278 N050278 A061658 A061888 A061658 A061888 A061725 A062175 A062332

003 001 001 001 002 002 001 001 001

CYCLOPAR WARNER CHILCOTT

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TETRACYCLINE HYDROCHLORIDE
CAPSULE; ORAL CYCLOPAR WARNER CHILCOTT PANMYCIN PHARMACIA AND UPJOHN RETET SOLVAY ROBITET WYETH AYERST SUMYCIN APOTHECON

6 - 317 (of 346)

500MG 500MG 250MG 250MG 500MG 250MG 500MG 100MG 125MG 250MG 500MG

A061725 A062332 A060347 A061443 A061443 A061734 A061734 A060429 A060429 A060429 A060429 A060343 A060343 A061802 A061802 A060059 A060173 A060173 A061148 A061148 A062752 A062752 A062085 A060736 A060736 A060783 A060783 A060290 A060290 A062686 A062686 A061214 A061471 A062540 A062540 A060471 A060471 A062300 A062300 A062103 A062343 A062103 A062343 A060768 A060768 A061685 A061685 A060082 A060082

002 002 001 001 002 001 002 002 004 001 003 001 003 001 002 001 001 002 001 002 001 002 001 001 002 001 002 001 002 001 002 002 001 001 002 001 002 001 002 001 001 002 002 001 002 001 002 003 004

250MG 500MG TETRACYCLINE HYDROCHLORIDE ABBOTT 250MG 500MG ELKINS SINN 250MG FERRANTE 125MG 250MG HEATHER 250MG 500MG LABS ATRAL 250MG 500MG MAST MM 250MG MUTUAL PHARM 250MG 500MG MYLAN 250MG 500MG PUREPAC PHARM 250MG 500MG PVT FORM 250MG 500MG ROXANE 500MG SANDOZ 250MG SUPERPHARM 250MG 500MG VALEANT PHARM INTL 250MG 500MG WARNER CHILCOTT 250MG 500MG WATSON LABS 250MG 250MG 500MG 500MG WEST WARD 250MG 500MG WYETH AYERST 250MG 500MG TETRACYN PFIPHARMECS 250MG 500MG FIBER, EXTENDED RELEASE; PERIODONTAL ACTISITE SCHIFF AND CO 12.7MG/FIBER

TETRACHEL ANGUS

Aug 12, 1988 Aug 12, 1988

Jul 24, 1986 Jul 24, 1986

Mar 21, 1985 Mar 21, 1985

N050653

001

Mar 25, 1994

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TETRACYCLINE HYDROCHLORIDE
FOR SOLUTION; TOPICAL TOPICYCLINE SHIRE INJECTABLE; INJECTION ACHROMYCIN LEDERLE TETRACYN PFIZER

6 - 318 (of 346)

2.2MG/ML

N050493

001

250MG/VIAL 500MG/VIAL 250MG/VIAL 500MG/VIAL

N050273 N050273 A060096 A060096

002 003 001 002

OINTMENT; OPHTHALMIC ACHROMYCIN STORZ 10MG/GM SUSPENSION; ORAL ACHROMYCIN V LEDERLE 125MG/5ML SUMYCIN PAR PHARM 125MG/5ML TETRACYCLINE HYDROCHLORIDE ALPHARMA US PHARMS 125MG/5ML FERRANTE 125MG/5ML PROTER 125MG/5ML PUREPAC PHARM 125MG/5ML TETRACYN PFIPHARMECS 125MG/5ML TETRAMED IVAX SUB TEVA PHARMS 125MG/5ML SUSPENSION/DROPS; OPHTHALMIC ACHROMYCIN STORZ 1% TABLET; ORAL PANMYCIN PHARMACIA AND UPJOHN 250MG 500MG SUMYCIN PAR PHARM 50MG 100MG 250MG 500MG

N050266

001

N050263 A060400 A060633 A060174 A060446 A060291 A060095 A061468

002 001 001 001 001 001 001 001

N050268

001

A061705 A061705 A061147 A061147 A061147 A061147

001 002 003 002 001 004

TETRACYCLINE PHOSPHATE COMPLEX

CAPSULE; ORAL TETREX BRISTOL

EQ EQ EQ EQ EQ EQ EQ

100MG 250MG 250MG 250MG 500MG 500MG 500MG

HCL HCL HCL HCL HCL HCL HCL

A061653 A061653 A061889 N050212 A061653 A061889 N050212

001 002 002 002 003 001 003

THALLOUS CHLORIDE TL-201

INJECTABLE; INJECTION THALLOUS CHLORIDE TL 201 BRACCO 1mCi/ML TRACE LIFE 1mCi/ML

N018548 A075569

001 001

Dec 30, 1982 Nov 21, 2001

THEOPHYLLINE
CAPSULE; ORAL BRONKODYL SANOFI AVENTIS US

100MG 200MG

A085264 A085264

001 002

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THEOPHYLLINE
CAPSULE; ORAL ELIXOPHYLLIN FOREST LABS SOMOPHYLLIN-T FISONS

6 - 319 (of 346)

100MG 200MG 100MG 200MG 250MG

A085545 A083921 A087155 A087155 A087155 A085263 A085263 A084731 A084731 A084731

001 001 001 002 003 001 002 002 001 003

Jul 31, 1984 Jul 31, 1984 Feb 25, 1985 Feb 25, 1985 Feb 25, 1985

100MG 200MG SCHERER RP 100MG 200MG 250MG CAPSULE, EXTENDED RELEASE; ORAL AEROLATE III FLEMING PHARMS 65MG AEROLATE JR FLEMING PHARMS 130MG AEROLATE SR FLEMING PHARMS 260MG ELIXOPHYLLIN SR FOREST LABS 125MG 250MG SLO-BID SANOFI AVENTIS US 50MG 75MG 100MG 125MG 200MG 300MG SLO-PHYLLIN SANOFI AVENTIS US 60MG 125MG 250MG SOMOPHYLLIN-CRT GRAHAM DM 50MG 100MG 200MG 250MG 300MG THEOBID WHITBY 260MG THEOBID JR. WHITBY 130MG THEOCLEAR L.A.-130 SCHWARZ PHARMA 130MG THEOCLEAR L.A.-260 SCHWARZ PHARMA 260MG THEO-DUR SCHERING 50MG 75MG 125MG 200MG THEOPHYLLINE CENT PHARMS 125MG 250MG HOSPIRA 100MG 200MG 300MG SANDOZ 260MG

THEOPHYLLINE KV PHARM

Nov 07, 1986 Nov 07, 1986 Nov 07, 1986

A085075 A085075 A085075 A086826 A086826 A088269 A089539 A087892 A089540 A087893 A087894 A085206 A085203 A085205 A087763 A087194 A088382 A087193 A088383 A085983 A087854 A086569 A086569 A088022 A088015 A088016 A087995 A088654 A088689 A089976 A089977 A089932 A087462

003 002 001 001 002 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 002 001 001 001 001 001 001 001 001 001 001

Nov 24, 1986 Nov 24, 1986 Nov 24, 1986 Jan 29, 1985 Jan 29, 1985 Jan May Jan May Jan Jan 31, 10, 31, 10, 31, 31, 1985 1989 1985 1989 1985 1985

May 24, 1982 May 24, 1982 May 24, 1982 Feb 27, 1985 Feb 27, 1985 Feb 27, 1985 Mar 20, 1985 Mar 20, 1985 May 27, 1982 May 27, 1982 Sep Sep Sep Sep Feb Feb Jan Jan Jan May 10, 10, 10, 10, 12, 12, 04, 04, 04, 11, 1985 1985 1985 1985 1985 1985 1995 1995 1995 1982

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

THEOPHYLLINE
CAPSULE, EXTENDED RELEASE; ORAL THEOPHYLLINE-SR SCHERER RP 300MG THEOPHYL-SR ORTHO MCNEIL PHARM 125MG 250MG THEOVENT SCHERING 125MG 250MG ELIXIR; ORAL ELIXOMIN CENCI 80MG/15ML LANOPHYLLIN LANNETT 80MG/15ML THEOLIXIR PANRAY 80MG/15ML THEOPHYL-225 ORTHO MCNEIL PHARM 112.5MG/15ML THEOPHYLLINE ALPHARMA US PHARMS 80MG/15ML CENCI 80MG/15ML HALSEY 80MG/15ML PERRIGO 80MG/15ML PHARM ASSOC 80MG/15ML PRECISION DOSE 80MG/15ML ROXANE 80MG/15ML TARO 80MG/15ML WOCKHARDT 80MG/15ML INJECTABLE; INJECTION THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER B BRAUN 40MG/100ML THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER B BRAUN 80MG/100ML THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER B BRAUN 160MG/100ML THEOPHYLLINE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER B BRAUN 200MG/100ML 200MG/100ML THEOPHYLLINE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER B BRAUN 4MG/ML 400MG/100ML 400MG/100ML THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER HOSPIRA INC 80MG/100ML 200MG/100ML 400MG/100ML SOLUTION; ORAL AEROLATE FLEMING PHARMS 150MG/15ML THEOLAIR 3M 80MG/15ML THEOPHYLLINE ROXANE 80MG/15ML SUSPENSION; ORAL ELIXICON FOREST LABS 100MG/5ML SYRUP; ORAL ACCURBRON SANOFI AVENTIS US 150MG/15ML AQUAPHYLLIN FERNDALE LABS 80MG/15ML SLO-PHYLLIN SANOFI AVENTIS US 80MG/15ML

6 - 320 (of 346)

A088255 A086480 A086471 A087010 A087910

001 001 001 001 001

Jun 12, 1986 Feb 08, 1985 Feb 08, 1985 Jan 31, 1985 Jan 31, 1985

A088303 A084578 A084559 A086485 A089223 A087679 A085169 A085952 A086720 A085863 A084739 A089626 A086748

001 001 001 001 001 001 001 001 001 001 001 001 001

Jan 25, 1984

May 27, 1988 Apr 15, 1982

Oct 28, 1988

N019083 N019083 N019083 N019212 N019826 N019212 N019212 N019826 N019211 N019211 N019211

001 002 003 001 004 003 002 005 002 004 005

Nov 07, 1984 Nov 07, 1984 Nov 07, 1984 Nov 07, 1984 Aug 14, 1992 Nov 07, 1984 Nov 07, 1984 Aug 14, 1992 Dec 14, 1984 Dec 14, 1984 Dec 14, 1984

A089141 A086107 A087449

001 001 001

Dec 03, 1986

Sep 15, 1983

A085502

001

A088746 A087917 A085187

001 001 001

Nov 22, 1985 Jan 18, 1983

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

THEOPHYLLINE
SYRUP; ORAL THEOCLEAR-80 CENT PHARMS THEOPHYLLINE ALPHARMA US PHARMS TABLET; ORAL QUIBRON-T MONARCH PHARMS SLO-PHYLLIN SANOFI AVENTIS US THEOCLEAR-100 CENT PHARMS THEOCLEAR-200 CENT PHARMS THEOPHYL-225 ORTHO MCNEIL PHARM TABLET, CHEWABLE; ORAL THEOPHYL ORTHO MCNEIL PHARM TABLET, EXTENDED RELEASE; DURAPHYL FOREST LABS

6 - 321 (of 346)

80MG/15ML 80MG/15ML 150MG/15ML

A087095 A086001 A086545

001 001 001

Mar 01, 1982

300MG 100MG 200MG 100MG 200MG 225MG

A088656 A085202 A085204 A085353 A085353 A084726

001 001 001 002 001 001

Aug 22, 1985

100MG ORAL 100MG 200MG 300MG 250MG 300MG 100MG 300MG 100MG 200MG 300MG 450MG 200MG 250MG 300MG 500MG 300MG 400MG 450MG 600MG 200MG 400MG 600MG 400MG 600MG

A086506

001

Sep 12, 1985

A088503 A088504 A088505 A087225 A087563 A085665 A085665 A085328 A086998 A085328 A089131 A088369 A086363 A088364 A089132 A040548 A040543 A040546 A040539 A088253 A089822 A089823 A087571 A040086

001 001 001 001 001 001 002 001 001 002 001 001 002 001 001 001 001 001 001 001 001 001 001 001

Apr 03, 1985 Apr 03, 1985 Apr 03, 1985

LABID WARNER CHILCOTT QUIBRON-T/SR MONARCH PHARMS SUSTAIRE ROERIG THEO-DUR SCHERING

Jun 21, 1983

Jun 25, 1986 Jul Jul Jul Jul Apr Apr Apr Apr 16, 16, 16, 16, 30, 27, 30, 27, 1987 1987 1987 1987 2004 2004 2004 2004

THEOLAIR-SR 3M

THEOPHYLLINE ABLE

T-PHYL PHARM RES ASSOC UNI-DUR SCHERING UNIPHYL PURDUE PHARM PRODS

Aug 17, 1983 Jan 04, 1995 Jan 04, 1995 Sep 01, 1982 Apr 15, 1996

THEOPHYLLINE SODIUM GLYCINATE

ELIXIR; ORAL SYNOPHYLATE CENT PHARMS

EQ 165MG BASE/15ML

N006333

008

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

THEOPHYLLINE SODIUM GLYCINATE
TABLET; ORAL ASBRON NOVARTIS

6 - 322 (of 346)

EQ 150MG BASE

A085148

001

THIABENDAZOLE
SUSPENSION; ORAL MINTEZOL MERCK TABLET, CHEWABLE; ORAL MINTEZOL MERCK

500MG/5ML

N016097

001

500MG

N016096

001

THIAMINE HYDROCHLORIDE
INJECTABLE; INJECTION BETALIN S LILLY THIAMINE HYDROCHLORIDE ABRAXIS PHARM AKORN BAXTER HLTHCARE BEL MAR DELL LABS HOSPIRA LUITPOLD PARKE DAVIS WATSON LABS WYETH AYERST

100MG/ML 100MG/ML 100MG/ML 100MG/ML 100MG/ML 200MG/ML 100MG/ML 100MG/ML 100MG/ML 100MG/ML 100MG/ML 200MG/ML 100MG/ML

A080853 A080509 A087968 A080575 A080718 A080712 A083775 A040079 A080667 A080770 A083534 A083534 A080553

001 001 001 001 001 001 001 001 001 001 001 002 001

Oct 01, 1982

May 03, 1996

THIAMYLAL SODIUM
INJECTABLE; INJECTION SURITAL PARKEDALE

1GM/VIAL 5GM/VIAL 10GM/VIAL

N007600 N007600 N007600

003 005 009

THIETHYLPERAZINE MALATE
INJECTABLE; INJECTION TORECAN NOVARTIS

5MG/ML

N012754

002

THIETHYLPERAZINE MALEATE
SUPPOSITORY; RECTAL TORECAN NOVARTIS TABLET; ORAL TORECAN NOVARTIS

10MG

N013247

001

10MG

N012753

001

THIOPENTAL SODIUM
SUSPENSION; RECTAL PENTOTHAL ABBOTT

400MG/GM

N011679

001

THIORIDAZINE
SUSPENSION; ORAL MELLARIL-S NOVARTIS

EQ 25MG HCL/5ML EQ 100MG HCL/5ML

N017923 N017923

001 002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

THIORIDAZINE HYDROCHLORIDE
CONCENTRATE; ORAL MELLARIL NOVARTIS

6 - 323 (of 346)

30MG/ML 100MG/ML THIORIDAZINE HYDROCHLORIDE ACTAVIS MID ATLANTIC 100MG/ML ALPHARMA US PHARMS 30MG/ML HI TECH PHARMA 30MG/ML 100MG/ML PHARM ASSOC 30MG/ML 100MG/ML SANDOZ 30MG/ML 100MG/ML TEVA PHARMS 30MG/ML 100MG/ML WOCKHARDT 30MG/ML 100MG/ML THIORIDAZINE HYDROCHLORIDE INTENSOL ROXANE 30MG/ML 100MG/ML TABLET; ORAL MELLARIL NOVARTIS 10MG 15MG 25MG 50MG 100MG 150MG 200MG THIORIDAZINE HYDROCHLORIDE IVAX PHARMS 10MG 15MG 25MG 50MG 100MG MUTUAL PHARM 10MG 15MG 25MG 50MG 100MG 150MG 200MG MYLAN 10MG 25MG 50MG 100MG PAR PHARM 10MG 15MG 25MG 50MG 100MG 150MG 200MG ROXANE 10MG 25MG 50MG 100MG SANDOZ 10MG 15MG 25MG 50MG 100MG

N011808 N011808 A088229 A087766 A040125 A040126 A040187 A040213 A088307 A088308 A089602 A089603 A088258 A088227 A088941 A088942

012 018 001 001 001 001 001 001 001 001 001 001 001 001 001 001 Aug Apr Aug Aug Aug May Nov Nov Nov Nov Jul Jul 23, 26, 16, 16, 28, 29, 23, 23, 09, 09, 25, 05, 1983 1983 1996 1996 1997 1998 1983 1983 1987 1987 1983 1983

Dec 16, 1985 Dec 16, 1985

N011808 N011808 N011808 N011808 N011808 N011808 N011808 A088270 A088271 A088272 A088194 A088273 A088375 A088461 A087264 A088370 A088379 A088737 A088738 A088332 A088333 A088334 A088335 A088351 A088352 A088336 A088322 A088480 A089764 A089765 A088663 A088664 A088665 A089048 A088131 A088132 A088133 A088134 A088135

003 016 006 011 009 017 015 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 Apr Apr Apr Apr Oct Nov Nov Nov Nov Nov Sep Oct Jun Jun Jun Nov Dec Dec Dec Dec Dec Feb Feb Mar Mar Mar Feb Aug Aug Aug Aug Nov 14, 14, 14, 14, 03, 18, 18, 18, 18, 16, 26, 16, 27, 27, 27, 18, 05, 05, 05, 05, 29, 09, 09, 15, 15, 15, 26, 30, 30, 30, 30, 20, 1983 1983 1983 1983 1983 1983 1983 1983 1983 1983 1984 1984 1983 1983 1983 1983 1983 1983 1983 1983 1983 1988 1988 1984 1984 1984 1985 1983 1983 1983 1983 1984

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

THIORIDAZINE HYDROCHLORIDE
TABLET; ORAL THIORIDAZINE HYDROCHLORIDE SANDOZ 150MG 200MG SUPERPHARM 10MG 25MG 50MG TEVA 10MG 100MG WATSON LABS 10MG 10MG 10MG 15MG 15MG 15MG 25MG 25MG 25MG 25MG 50MG 50MG 50MG 100MG 100MG 100MG 150MG 150MG 200MG 200MG WEST WARD 10MG 15MG 25MG 50MG

6 - 324 (of 346)

A088136 A088137 A089103 A089104 A089105 A088493 A088456 A088412 A088476 A088561 A088345 A088477 A088562 A088296 A088478 A088567 A088755 A088323 A088479 A088563 A088284 A088564 A088736 A088410 A088869 A088381 A088872 A088658 A088659 A088660 A088661

001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001

Sep Sep Jul Jul Jul May May Sep Nov May Jul Nov May Jul Nov May Jul Jul Nov May Aug May Jul Mar Jun Mar Apr Mar Mar Mar Mar

17, 17, 02, 02, 02, 17, 17, 12, 08, 11, 28, 08, 11, 28, 08, 11, 24, 28, 08, 11, 25, 11, 24, 05, 28, 14, 26, 26, 26, 26, 26,

1986 1986 1985 1985 1985 1985 1985 1983 1983 1984 1983 1983 1984 1983 1983 1984 1984 1983 1983 1984 1983 1984 1984 1984 1985 1984 1985 1984 1984 1984 1984

THIOTEPA
INJECTABLE; INJECTION THIOPLEX IMMUNEX THIOTEPA APP PHARMS IMMUNEX TEVA PARENTERAL

15MG/VIAL 15MG/VIAL 15MG/VIAL 15MG/VIAL 30MG/VIAL

N020058 A075698 N011683 A075730 A075730

001 001 001 001 002

Dec 22, 1994 Sep 20, 2001 Apr 20, 2001 Apr 20, 2001

THIOTHIXENE
CAPSULE; ORAL NAVANE PFIZER THIOTHIXENE AM THERAP

20MG 1MG 2MG 5MG 10MG 20MG 1MG 2MG 5MG 10MG 10MG

N016584 A071884 A071885 A071886 A071887 A072200 A070600 A071626 A071627 A070603 A071628

005 001 001 001 001 001 001 001 001 001 001 Aug Aug Aug Aug Dec Jun Jun Jun Jun Jun 12, 12, 12, 12, 17, 05, 25, 25, 05, 25, 1987 1987 1987 1987 1987 1987 1987 1987 1987 1987

WATSON LABS

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

THIOTHIXENE HYDROCHLORIDE
CONCENTRATE; ORAL NAVANE PFIZER EQ 5MG BASE/ML THIOTHIXENE HYDROCHLORIDE ALPHARMA US PHARMS EQ 5MG BASE/ML PACO EQ 1MG BASE/ML EQ 5MG BASE/ML TEVA EQ 5MG BASE/ML TEVA PHARMS EQ 5MG BASE/ML THIOTHIXENE HYDROCHLORIDE INTENSOL ROXANE EQ 5MG BASE/ML INJECTABLE; INJECTION NAVANE PFIZER EQ 2MG BASE/ML EQ 10MG BASE/VIAL

6 - 325 (of 346)

N016758 A070969 A071917 A071939 A071184 A071554 A073494

001 001 001 001 001 001 001 Oct Sep Dec Jun Oct 16, 20, 16, 22, 16, 1987 1989 1988 1987 1987

Jun 30, 1992

N016904 N016904

001 002

THYROGLOBULIN
TABLET; ORAL PROLOID PARKE DAVIS

16MG 32MG 65MG 100MG 130MG 200MG 325MG 64.8MG

N002245 N002245 N002245 N002245 N002245 N002245 N002245 A080151

009 005 002 008 010 007 004 001

THYROGLOBULIN IMPAX LABS

THYROTROPIN
INJECTABLE; INJECTION THYTROPAR SANOFI AVENTIS US

10 IU/VIAL

N008682

001

TIAGABINE HYDROCHLORIDE
TABLET; ORAL GABITRIL CEPHALON

20MG

N020646

004

Sep 30, 1997

TICARCILLIN DISODIUM
INJECTABLE; INJECTION TICAR GLAXOSMITHKLINE

EQ EQ EQ EQ EQ EQ

1GM BASE/VIAL 3GM BASE/VIAL 3GM BASE/VIAL 6GM BASE/VIAL 20GM BASE/VIAL 30GM BASE/VIAL

N050497 A062690 N050497 N050497 N050497 N050497

001 001 002 003 004 005

Dec 19, 1986

Apr 04, 1984

TICLOPIDINE HYDROCHLORIDE
TABLET; ORAL TICLID ROCHE PALO

125MG 250MG TICLOPIDINE HYDROCHLORIDE ACTAVIS ELIZABETH 250MG MYLAN 250MG SANDOZ 250MG WATSON LABS 250MG

N019979 N019979 A075253 A075316 A075318 A075309

001 002 001 001 001 001

Mar 24, 1993 Oct 31, 1991 Aug Nov Aug Apr 20, 02, 20, 26, 1999 1999 1999 2000

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

TIMOLOL MALEATE
SOLUTION/DROPS; OPHTHALMIC TIMOLOL MALEATE AKORN EQ 0.25% BASE FOUGERA EQ 0.25% BASE EQ 0.5% BASE TABLET; ORAL BLOCADREN MERCK 5MG 10MG 20MG TIMOLOL MALEATE QUANTUM PHARMICS 5MG 10MG 20MG SANDOZ 5MG 10MG 20MG TEVA 5MG 10MG 20MG USL PHARMA 5MG 10MG 20MG WATSON LABS 5MG 5MG 10MG 10MG 20MG 20MG

6 - 326 (of 346)

A074465 A074667 A074668

001 001 001

Mar 25, 1997 Mar 25, 1997 Mar 25, 1997

N018017 N018017 N018017 A072466 A072467 A072468 A072550 A072551 A072552 A072648 A072649 A072650 A072001 A072002 A072003 A072269 A072917 A072270 A072918 A072271 A072919

001 002 004 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 May May May Apr Apr Apr Jun Jun Jun Apr Apr Apr Apr Jul Apr Jul Apr Jul 19, 19, 19, 13, 13, 13, 16, 16, 16, 11, 11, 11, 11, 31, 11, 31, 11, 31, 1989 1989 1989 1989 1989 1989 1993 1993 1993 1989 1989 1989 1989 1991 1989 1991 1989 1991

TIOCONAZOLE
CREAM; TOPICAL TZ-3 PFIZER

1%

N018682

001

Feb 18, 1983

TIROFIBAN HYDROCHLORIDE
INJECTABLE; INJECTION AGGRASTAT MEDICURE

EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML) N020912 EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML) N020913

001 001

May 14, 1998 May 14, 1998

TIZANIDINE HYDROCHLORIDE
TABLET; ORAL TIZANIDINE HYDROCHLORIDE ACTAVIS ELIZABETH EQ EQ ACTAVIS TOTOWA EQ EQ BARR EQ EQ IVAX SUB TEVA PHARMS EQ EQ ZANAFLEX ACORDA EQ

2MG 4MG 2MG 4MG 2MG 4MG 2MG 4MG

BASE BASE BASE BASE BASE BASE BASE BASE

A076283 A076283 A076281 A076281 A076371 A076371 A076321 A076321 N020397

001 002 001 002 001 002 001 002 002

Jul Jul Oct Oct Apr Apr Sep Sep

12, 12, 20, 20, 09, 09, 30, 30,

2002 2002 2003 2003 2003 2003 2004 2004

2MG BASE

Feb 04, 2000

TOBRAMYCIN
SOLUTION/DROPS; OPHTHALMIC TOBRAMYCIN ALCON UNIVERSAL 0.3%

A063176

001

May 25, 1994

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

TOBRAMYCIN SULFATE
INJECTABLE; INJECTION NEBCIN LILLY

6 - 327 (of 346)

EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ

10MG BASE/ML 10MG BASE/ML 10MG BASE/ML 40MG BASE/ML 1.2GM BASE/VIAL 40MG 40MG 10MG 40MG 40MG 40MG 10MG 10MG 40MG 40MG 10MG 40MG 40MG BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML BASE/ML

A062008 A062707 N050477 A062008 N050519 A064021 A064026 A063119 A063120 A063121 A063122 A063113 A063128 A063118 A063127 A063080 A063161 A062945

004 001 005 001 001 002 001 001 001 001 001 001 001 001 001 001 001 002

Apr 29, 1987

TOBRAMYCIN SULFATE APOTHECON ASTRAZENECA

BAXTER HLTHCARE

HOSPIRA MARSAM PHARMS LLC

May May Oct Oct Oct Oct Apr Nov Jul Nov Apr May Aug

31, 31, 31, 31, 31, 31, 26, 27, 29, 27, 30, 29, 09,

1994 1994 1994 1994 1994 1994 1991 1991 1991 1991 1991 1991 1989

TOCAINIDE HYDROCHLORIDE
TABLET; ORAL TONOCARD ASTRAZENECA

400MG 600MG

N018257 N018257

001 002

Nov 09, 1984 Nov 09, 1984

TOLAZAMIDE
TABLET; ORAL TOLAZAMIDE BARR

DURAMED PHARMS BARR

INTERPHARM IVAX SUB TEVA PHARMS

MUTUAL PHARM

PAR PHARM

SANDOZ

SUPERPHARM USL PHARMA

WATSON LABS

100MG 250MG 500MG 100MG 250MG 500MG 250MG 500MG 100MG 250MG 500MG 100MG 250MG 500MG 100MG 250MG 500MG 100MG 250MG 500MG 250MG 500MG 100MG 250MG 500MG 100MG 100MG 250MG 500MG 100MG

A070162 A070163 A070164 A070165 A070166 A070167 A071270 A071271 N018894 N018894 N018894 A071357 A071358 A071359 A070159 A070160 A070161 A071633 A070289 A070290 A070763 A070764 A071355 A070168 A070169 A070242 A070513 A070243 A070244 N015500

001 001 001 001 001 001 001 001 001 002 003 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 002

Jan Jan Jan Jan Jan Jan Sep Sep Nov Nov Nov Jul Jul Jul Jan Jan Jan Dec Mar Mar Jun Jun Jan Apr Apr Aug Jan Aug Aug

14, 14, 14, 10, 10, 10, 23, 23, 02, 02, 02, 16, 16, 16, 06, 06, 06, 09, 13, 13, 16, 16, 11, 02, 02, 01, 09, 01, 01,

1986 1986 1986 1986 1986 1986 1986 1986 1984 1984 1984 1987 1987 1987 1986 1986 1986 1987 1986 1986 1986 1986 1988 1986 1986 1986 1986 1986 1986

TOLINASE PHARMACIA AND UPJOHN

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

TOLAZAMIDE
TABLET; ORAL TOLINASE PHARMACIA AND UPJOHN

6 - 328 (of 346)

250MG 500MG

N015500
004 N015500
005

TOLAZOLINE HYDROCHLORIDE
INJECTABLE; INJECTION PRISCOLINE NOVARTIS

25MG/ML

N006403
005

Feb 22, 1985

TOLBUTAMIDE
TABLET; ORAL ORINASE PHARMACIA AND UPJOHN TOLBUTAMIDE ALRA ASCOT BARR CLONMEL HLTHCARE IVAX PHARMS PARKE DAVIS PUREPAC PHARM SANDOZ SUPERPHARM VANGARD WATSON LABS

250MG 500MG 500MG 500MG 500MG 500MG 500MG 500MG 500MG 500MG 500MG 500MG 500MG 250MG 500MG

N010670
002 N010670
001 A086141 A087541 A087121 A086926 A087093 A086047 A088950 A086574 N012678 A088893 A087876 A089110 A089111 001 001 001 001 001 001 001 001 001 001 001 001 001

Mar 01, 1983

Jun 17, 1985

Nov Apr May May

19, 20, 29, 29,

1984 1982 1987 1987

TOLBUTAMIDE SODIUM
INJECTABLE; INJECTION ORINASE DIAGNOSTIC PHARMACIA AND UPJOHN

EQ 1GM BASE/VIAL

N012095

001

TOLCAPONE
TABLET; ORAL TASMAR VALEANT PHARM INTL

200MG

N020697

002

Jan 29, 1998

TOLMETIN SODIUM
CAPSULE; ORAL TOLECTIN DS ORTHO MCNEIL JANSSEN TOLMETIN SODIUM ACTAVIS ELIZABETH IVAX SUB TEVA PHARMS MUTUAL PHARM SANDOZ TEVA TABLET; ORAL TOLECTIN ORTHO MCNEIL JANSSEN TOLECTIN 600 ORTHO MCNEIL JANSSEN TOLMETIN SODIUM ACTAVIS ELIZABETH IVAX SUB TEVA PHARMS SANDOZ TEVA

EQ 400MG BASE EQ EQ EQ EQ EQ 400MG 400MG 400MG 400MG 400MG BASE BASE BASE BASE BASE

N018084 A073308 A073392 A073311 A073462 A073519

001 001 001 001 001 001 Jan Jan Nov Apr May 24, 24, 27, 30, 29, 1992 1992 1991 1992 1992

EQ 200MG BASE EQ 600MG BASE EQ EQ EQ EQ EQ 600MG 600MG 200MG 600MG 600MG BASE BASE BASE BASE BASE

N017628 N017628 A073527 A074399 A073588 A074002 A074729

001 002 001 001 001 001 001 Mar 08, 1989 Jun Mar Jul Sep Feb 30, 28, 31, 27, 27, 1992 1996 1992 1993 1997

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

TOLVAPTAN
TABLET; ORAL SAMSCA OTSUKA AMERICA PHARM

6 - 329 (of 346)

60MG

N022275

003

May 19, 2009

TOPIRAMATE
CAPSULE; ORAL TOPAMAX SPRINKLE JANSSEN PHARMS TOPIRAMATE BARR TABLET; ORAL TOPAMAX JANSSEN PHARMS TOPIRAMATE BARR

50MG 15MG 25MG

N020844 A076448 A076448

003 001 002

Oct 26, 1998 Apr 15, 2009 Apr 15, 2009

300MG 400MG 25MG 100MG 200MG 25MG 50MG 100MG 200MG 25MG 50MG 100MG 200MG

N020505 N020505 A076315 A076315 A076315 A077905 A077905 A077905 A077905 A076306 A076306 A076306 A076306

003 006 001 002 003 001 002 003 004 001 002 003 004

Dec 24, 1996 Dec 24, 1996 Mar Mar Mar Mar Mar Mar Mar Mar Mar Mar Mar 27, 27, 27, 30, 30, 30, 30, 27, 27, 27, 27, 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009

PLIVA HRVATSKA DOO

ROXANE

TOPOTECAN HYDROCHLORIDE
SOLUTION; INTRAVENOUS TOPOTECAN SANDOZ INC

EQ 1MG BASE/ML (EQ 1MG BASE/ML) EQ 3MG BASE/3ML (EQ 1MG BASE/ML) EQ 4MG BASE/4ML (EQ 1MG BASE/ML)

N200199 N200199 N200199

001 002 003

Feb 25, 2011 Feb 25, 2011 Feb 25, 2011

TORSEMIDE
INJECTABLE; INJECTION DEMADEX ROCHE

50MG/5ML (10MG/ML) 20MG/2ML (10MG/ML)

N020137 N020137

002 001

Aug 23, 1993 Aug 23, 1993

TRAMADOL HYDROCHLORIDE
TABLET; ORAL TRAMADOL HYDROCHLORIDE ACTAVIS ELIZABETH ASTA IVAX SUB TEVA PHARMS ULTRAM JANSSEN PHARMS

50MG 50MG 50MG 100MG

A075960 A075974 A075963 N020281

001 001 001 001

Jun 19, 2002 Jul 12, 2002 Jul 03, 2002 Mar 03, 1995

TRANEXAMIC ACID
TABLET; ORAL CYKLOKAPRON PHARMACIA AND UPJOHN

500MG

N019280

001

Dec 30, 1986

TRAVOPROST
SOLUTION/DROPS; OPHTHALMIC TRAVATAN ALCON PHARMS LTD 0.004%

N021257

001

Mar 16, 2001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

TRAZODONE HYDROCHLORIDE
TABLET; ORAL DESYREL APOTHECON

6 - 330 (of 346)

50MG 100MG 150MG 300MG

N018207 N018207 N018207 N018207 A071139 A071140 A071405 A071406 A070921 A072484 A072483 A074357 A070491 A070492 A071112 A071113 A070942

001 002 003 004 001 001 001 001 001 001 001 001 001 001 001 001 001

Mar 25, 1985 Nov 07, 1988 Oct Oct Feb Feb Dec Apr Apr Apr Apr Apr Nov Nov 29, 29, 27, 27, 01, 30, 30, 30, 29, 29, 17, 17, 1986 1986 1991 1991 1986 1990 1990 1997 1987 1987 1986 1986

TRAZODONE HYDROCHLORIDE AM THERAP 50MG 100MG MYLAN 50MG 100MG QUANTUM PHARMICS 100MG 50MG SANDOZ 100MG 150MG TEVA 50MG USL PHARMA 100MG 50MG WATSON LABS 100MG TRIALODINE QUANTUM PHARMICS 50MG

Dec 01, 1986

TRETINOIN
CAPSULE; ORAL VESANOID ROCHE SOLUTION; TOPICAL TRETINOIN TEVA PHARMS SWAB; TOPICAL RETIN-A ORTHO JANSSEN

10MG

N020438

001

Nov 22, 1995

0.05%

A074873

001

Jun 19, 1998

0.05%

N016921

002

TRIAMCINOLONE
TABLET; ORAL ARISTOCORT ASTELLAS

1MG 2MG 4MG 8MG 16MG 1MG 2MG 4MG 8MG 2MG 2MG 4MG 4MG 8MG 8MG 4MG 4MG 2MG 2MG 4MG 2MG 4MG 8MG 4MG

N011161 N011161 N011161 N011161 N011161 N011283 N011283 N011283 N011283 A084286 A084318 A084267 A084319 A084268 A084320 A084340 A083750 A084406 A084020 A084020 A084708 A084709 A084707 A085601

009 004 007 011 010 003 008 006 010 001 001 001 001 001 001 001 001 001 002 003 001 001 001 001

KENACORT BRISTOL MYERS SQUIBB

TRIAMCINOLONE BARR

IMPAX LABS IVAX SUB TEVA PHARMS MYLAN PUREPAC PHARM ROXANE

SANDOZ

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

TRIAMCINOLONE
TABLET; ORAL TRIAMCINOLONE TEVA WATSON LABS

6 - 331 (of 346)

4MG 4MG 4MG

A084775 A084270 A085834

001 001 001

TRIAMCINOLONE ACETONIDE
AEROSOL, METERED; NASAL NASACORT SANOFI AVENTIS US CREAM; TOPICAL ARISTOCORT ASTELLAS

0.055MG/INH

N019798

001

Jul 11, 1991

0.025% 0.1% 0.5% 0.025% 0.025% 0.1% 0.1% 0.5% 0.5% 0.025% 0.1% 0.5% 0.5% 0.1% 0.1% 0.1% 0.1% 0.025% 0.025% 0.1% 0.025% 0.1% 0.5% 0.025% 0.1% 0.5% 0.025% 0.1% 0.5% 0.025% 0.025% 0.1% 0.5% 0.025% 0.1% 0.5% 0.025% 0.1% 0.5%

A083017 A083016 A083015 A083017 A088818 A083016 A088819 A083015 A088820 A085539 A085539 A085539 A083943 A086240 A084908 A087113 A087798 A087797 A087932 A089798 A088094 A088095 A088096 A087990 A087991 A087992 A087921 A087912 A087922 A040038 A089274 A089275 A089276 A087430 A087429 A087428 A088196 A088197 A088198

003 004 002 004 001 005 001 003 001 001 002 003 001 001 002 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 Jun Jun May May Sep Sep Sep Jul Jul Jul Aug Aug Aug Oct Feb Feb Feb 04, 07, 09, 31, 01, 01, 01, 07, 07, 07, 10, 10, 10, 26, 21, 21, 21, 1982 1982 1983 1991 1983 1983 1983 1983 1983 1983 1982 1982 1982 1994 1989 1989 1989

ARISTOCORT A ASTELLAS

Oct 16, 1984 Oct 16, 1984 Oct 16, 1984

FLUTEX IVAX PHARMS

KENALOG APOTHECON KENALOG-H APOTHECON TRIACET TEVA TRIACORT SOLVAY TRIAMCINOLONE ACETONIDE ACTAVIS MID ATLANTIC ALPHARMA US PHARMS AMBIX G AND W LABS MORTON GROVE

PHARMADERM

PHARMAFAIR

TARO TOPIDERM

TRIATEX IVAX PHARMS

Nov 01, 1988 Nov 01, 1988 Nov 01, 1988 Mar 25, 1983 Mar 25, 1983 Mar 25, 1983

TRYMEX SAVAGE LABS

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

TRIAMCINOLONE ACETONIDE
GEL; TOPICAL ARISTOGEL ASTELLAS INJECTABLE; INJECTION TRIAMCINOLONE ACETONIDE PARNELL WATSON LABS LOTION; TOPICAL KENALOG APOTHECON BRISTOL MYERS SQUIBB

6 - 332 (of 346)

0.1%

A083380

001

3MG/ML 40MG/ML

N019503 A085825

001 001

Oct 16, 1987

0.025% 0.1% 0.025% 0.1%

A084343 A084343 N011602 N011602 A087191 A087192

001 002 003 001 001 001 Sep 08, 1982 Sep 08, 1982

TRIAMCINOLONE ACETONIDE ALPHARMA US PHARMS 0.025% 0.1% OINTMENT; TOPICAL ARISTOCORT ASTELLAS 0.1% 0.5% ARISTOCORT A ASTELLAS 0.1% 0.1% 0.5% 0.5% FLUTEX IVAX PHARMS 0.025% 0.1% 0.5% KENALOG APOTHECON 0.5% TRIAMCINOLONE ACETONIDE ACTAVIS MID ATLANTIC 0.1% ALPHARMA US PHARMS 0.5% G AND W LABS 0.025% 0.1% MORTON GROVE 0.025% 0.1% 0.5% PHARMADERM 0.025% 0.1% TRYMEX SAVAGE LABS 0.025% 0.1% PASTE; DENTAL KENALOG IN ORABASE APOTHECON 0.1% ORALONE TARO 0.1% SPRAY, METERED; NASAL ALLERNAZE LUPIN ATLANTIS 0.05MG/SPRAY NASACORT HFA SANOFI AVENTIS US 0.055MG/SPRAY

A080750 A080745 A080750 A088780 A080745 A088781 A087375 A087377 A087376 A083944 A087799 A089913 A089795 A089796 A088090 A088091 A088092 A088692 A088690 A088693 A088691

004 002 003 001 003 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 Jun Dec Dec Dec Sep Sep Sep Aug Aug 07, 23, 23, 23, 01, 01, 01, 02, 02, 1982 1988 1988 1988 1983 1983 1983 1984 1984

Oct 01, 1984 Oct 05, 1984 Nov 01, 1988 Nov 01, 1988 Nov 01, 1988

Aug 02, 1984 Aug 02, 1984

N012097 A071383

001 001 Jul 06, 1987

N020120 N020784

001 001

Feb 04, 2000 Apr 07, 2004

TRIAMCINOLONE DIACETATE
INJECTABLE; INJECTION ARISTOCORT SANDOZ

25MG/ML 40MG/ML

N011685 N012802 A085122 A086394

003 001 001 001

TRIAMCINOLONE DIACETATE AKORN 25MG/ML 40MG/ML

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

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TRIAMCINOLONE DIACETATE
INJECTABLE; INJECTION TRIAMCINOLONE DIACETATE WATSON LABS 40MG/ML 40MG/ML SYRUP; ORAL ARISTOCORT ASTELLAS 2MG/5ML KENACORT BRISTOL MYERS SQUIBB EQ 4MG BASE/5ML

6 - 333 (of 346)

A084072 A085529

001 001

N011960 N012515

004 001

TRIAZOLAM
TABLET; ORAL HALCION PHARMACIA AND UPJOHN

0.5MG

N017892

002

Nov 15, 1982

TRICHLORMETHIAZIDE
TABLET; ORAL METAHYDRIN SANOFI AVENTIS US NAQUA SCHERING TRICHLOREX LANNETT TRICHLORMAS MAST MM TRICHLORMETHIAZIDE IMPAX LABS PAR PHARM SANDOZ TG UNITED LABS WATSON LABS

2MG 4MG 2MG 4MG 4MG 4MG 4MG 4MG 2MG 4MG 4MG 4MG 2MG 2MG 4MG 4MG 4MG

N012594 N012594 N012265 N012265 A083436 A085630 A086259 A083967 A087007 A087005 A086171 A085568 A083847 A086458 A083462 A083855 A085962

001 002 001 002 001 001 001 001 001 001 001 001 001 001 001 001 001

Jun 16, 1988 Jun 16, 1988

TRICLOFOS SODIUM
SOLUTION; ORAL TRICLOS SANOFI AVENTIS US TABLET; ORAL TRICLOS SANOFI AVENTIS US

1.5GM/15ML

N016830

001

750MG

N016809

002

TRIDIHEXETHYL CHLORIDE
INJECTABLE; INJECTION PATHILON LEDERLE TABLET; ORAL PATHILON LEDERLE

10MG/ML

N009729

001

25MG

N009489

005

TRIFLUOPERAZINE HYDROCHLORIDE
CONCENTRATE; ORAL STELAZINE GLAXOSMITHKLINE EQ 10MG BASE/ML TRIFLUOPERAZINE HYDROCHLORIDE SANDOZ EQ 10MG BASE/ML

N011552 A085787

006 001 Apr 15, 1982

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DISCONTINUED DRUG PRODUCT LIST

TRIFLUOPERAZINE HYDROCHLORIDE
CONCENTRATE; ORAL TRIFLUOPERAZINE HYDROCHLORIDE WOCKHARDT EQ 10MG BASE/ML INJECTABLE; INJECTION STELAZINE GLAXOSMITHKLINE EQ 2MG BASE/ML TABLET; ORAL STELAZINE GLAXOSMITHKLINE EQ 1MG BASE EQ 2MG BASE EQ 5MG BASE EQ 10MG BASE TRIFLUOPERAZINE HYDROCHLORIDE DURAMED PHARMS BARR EQ 1MG BASE EQ 2MG BASE EQ 5MG BASE EQ 10MG BASE IVAX PHARMS EQ 1MG BASE EQ 2MG BASE EQ 5MG BASE EQ 10MG BASE SANDOZ EQ 1MG BASE EQ 2MG BASE EQ 5MG BASE EQ 10MG BASE WATSON LABS EQ 1MG BASE EQ 2MG BASE EQ 5MG BASE EQ 10MG BASE

6 - 334 (of 346)

A088143

001

Jul 26, 1983

N011552

005

N011552 N011552 N011552 N011552 A088967 A088968 A088969 A088970 A087612 A087613 A087328 A087614 A040153 A040153 A040153 A040153 A085975 A085976 A085973 A088710

001 002 003 004 001 001 001 001 001 001 001 001 001 002 003 004 001 001 001 001 Apr Apr Apr Apr Nov Nov Nov Nov Oct Oct Oct Oct Jun Jun Jun Jun 23, 23, 23, 23, 19, 19, 19, 19, 25, 25, 25, 25, 23, 23, 23, 23, 1985 1985 1985 1985 1982 1982 1982 1982 1996 1996 1996 1996 1988 1988 1988 1988

TRIFLUPROMAZINE
SUSPENSION; ORAL VESPRIN APOTHECON

EQ 50MG HCL/5ML

N011491

004

TRIFLUPROMAZINE HYDROCHLORIDE
INJECTABLE; INJECTION VESPRIN APOTHECON

3MG/ML 10MG/ML 20MG/ML

N011325 N011325 N011325

005 004 001

TABLET; ORAL VESPRIN BRISTOL MYERS SQUIBB

10MG 25MG 50MG

N011123 N011123 N011123

001 002 003

TRIHEXYPHENIDYL HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL ARTANE LEDERLE 5MG 5MG ELIXIR; ORAL ARTANE LEDERLE 2MG/5ML TRIHEXYPHENIDYL HYDROCHLORIDE PHARM VENTURES 2MG/5ML TABLET; ORAL ARTANE LEDERLE 2MG 5MG TREMIN SCHERING 2MG

N006773 N012947

010 001

N006773 A089514

009 001 Apr 07, 1989

N006773 N006773 A080381

005 003 001

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TRIHEXYPHENIDYL HYDROCHLORIDE
TABLET; ORAL TREMIN SCHERING 5MG TRIHEXYPHENIDYL HYDROCHLORIDE NYLOS 5MG VANGARD 2MG WATSON LABS 2MG 5MG

6 - 335 (of 346)

A080381 A085622 A088035 A085117 A085105

003 001 001 001 001

Jul 30, 1982

TRILOSTANE
CAPSULE; ORAL MODRASTANE BIOENVISION

30MG 60MG

N018719 N018719

002 001

Dec 31, 1984 Dec 31, 1984

TRIMEPRAZINE TARTRATE
CAPSULE, EXTENDED RELEASE; ORAL TEMARIL ALLERGAN HERBERT EQ 5MG BASE SYRUP; ORAL TEMARIL ALLERGAN HERBERT EQ 2.5MG BASE/5ML TRIMEPRAZINE TARTRATE ALPHARMA US PHARMS EQ 2.5MG BASE/5ML MORTON GROVE EQ 2.5MG BASE/5ML TABLET; ORAL TEMARIL ALLERGAN HERBERT EQ 2.5MG BASE

N011316

004

N011316 A085015 A088285

003 001 001 Feb 18, 1982 Apr 11, 1985

N011316

001

TRIMETHADIONE
CAPSULE; ORAL TRIDIONE ABBOTT SOLUTION; ORAL TRIDIONE ABBOTT

300MG

N005856

005

200MG/5ML

N005856

002

TRIMETHAPHAN CAMSYLATE
INJECTABLE; INJECTION ARFONAD ROCHE

50MG/ML

N008983

001

TRIMETHOBENZAMIDE HYDROCHLORIDE
INJECTABLE; INJECTION TRIMETHOBENZAMIDE HYDROCHLORIDE SMITH AND NEPHEW 100MG/ML 100MG/ML SOLOPAK 100MG/ML WATSON LABS 100MG/ML 100MG/ML

A088960 A089043 A089094 A086577 A087939

001 001 001 001 001

Apr Apr Apr Oct Dec

04, 04, 04, 19, 28,

1986 1986 1986 1982 1982

TRIMETHOPRIM
TABLET; ORAL PROLOPRIM MONARCH PHARMS TRIMETHOPRIM MUTUAL PHARM TRIMPEX ROCHE

100MG 200MG 100MG 200MG 100MG

N017943 N017943 A070494 A070495 N017952

001 003 001 001 001

Jul 14, 1982 Jan 22, 1986 Sep 24, 1986

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TRIMETHOPRIM
TABLET; ORAL TRIMPEX 200 ROCHE

6 - 336 (of 346)

200MG

N017952

002

Nov 09, 1982

TRIMETHOPRIM HYDROCHLORIDE
SOLUTION; ORAL PRIMSOL FSC

EQ 25MG BASE/5ML

A074374

001

Jun 23, 1995

TRIMETREXATE GLUCURONATE
INJECTABLE; INJECTION NEUTREXIN MEDIMMUNE ONCOLOGY

EQ 25MG BASE/VIAL EQ 200MG BASE/VIAL

N020326 N020326

001 002

Dec 17, 1993 Jul 31, 1998

TRIMIPRAMINE MALEATE
CAPSULE; ORAL TRIMIPRAMINE MALEATE USL PHARMA

EQ 25MG BASE EQ 50MG BASE EQ 100MG BASE

A071283 A071284 A071285

001 001 001

Dec 08, 1987 Dec 08, 1987 Dec 08, 1987

TRIOXSALEN
TABLET; ORAL TRISORALEN VALEANT PHARM INTL

5MG

N012697

001

TRIPELENNAMINE CITRATE
ELIXIR; ORAL PBZ NOVARTIS

EQ 25MG HCL/5ML

N005914

004

TRIPELENNAMINE HYDROCHLORIDE
TABLET; ORAL PBZ NOVARTIS

25MG 50MG TRIPELENNAMINE HYDROCHLORIDE ANABOLIC 50MG BARR 50MG HEATHER 50MG IMPAX LABS 50MG LANNETT 50MG NYLOS 50MG PARKE DAVIS 25MG 50MG WATSON LABS 50MG 50MG 50MG TABLET, EXTENDED RELEASE; ORAL PBZ-SR NOVARTIS 50MG 100MG

A083149 N005914 A083037 A080744 A083989 A080785 A083557 A085412 A083625 A083626 A080713 A080790 A085188

001 002 001 001 001 001 001 001 001 001 001 001 001

N010533 N010533

002 001

TRIPLE SULFA (SULFABENZAMIDE;SULFACETAMIDE;SULFATHIAZOLE)

CREAM; VAGINAL GYNE-SULF G AND W LABS SULTRIN ORTHO MCNEIL PHARM TRIPLE SULFA ALPHARMA US PHARMS

3.7%;2.86%;3.42% 3.7%;2.86%;3.42% 3.7%;2.86%;3.42%

A088607 N005794 A087864

001 001 001

Jun 09, 1986

Sep 01, 1982

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

TRIPLE SULFA (SULFABENZAMIDE;SULFACETAMIDE;SULFATHIAZOLE)
CREAM; VAGINAL TRIPLE SULFA FOUGERA PERRIGO NEW YORK TRYSUL SAVAGE LABS VAGILIA TEVA TABLET; VAGINAL SULTRIN ORTHO MCNEIL PHARM TRIPLE SULFA FOUGERA PHARMADERM

6 - 337 (of 346)

3.7%;2.86%;3.42% 3.7%;2.86%;3.42% 3.7%;2.86%;3.42% 3.7%;2.86%;3.42%

A086424 A087285 A087887 A088821

001 001 001 001

Nov 15, 1982 Jul 23, 1982 Nov 09, 1987

184MG;143.75MG;172.5MG 184MG;143.75MG;172.5MG 184MG;143.75MG;172.5MG

N005794 A088463 A088462

002 001 001 Jan 03, 1985 Jan 03, 1985

TRIPROLIDINE HYDROCHLORIDE
SYRUP; ORAL ACTIDIL GLAXOSMITHKLINE 1.25MG/5ML MYIDYL USL PHARMA 1.25MG/5ML TRIPROLIDINE HYDROCHLORIDE ALPHARMA US PHARMS 1.25MG/5ML HALSEY 1.25MG/5ML PHARM ASSOC 1.25MG/5ML TABLET; ORAL ACTIDIL GLAXOSMITHKLINE 2.5MG TRIPROLIDINE HYDROCHLORIDE VITARINE 2.5MG WATSON LABS 2.5MG

N011496 A087963 A085940 A088735 A087514

002 001 001 001 001

Jul 01, 1983 Jan 18, 1983

Jan 17, 1985 Feb 10, 1982

N011110 A085610 A085094

002 001 001

Jul 01, 1983

TRISULFAPYRIMIDINES (SULFADIAZINE;SULFAMERAZINE;SULFAMETHAZINE)
SUSPENSION; ORAL LANTRISUL LANNETT NEOTRIZINE LILLY SULFALOID FOREST PHARMS SULFOSE WYETH AYERST TERFONYL BRISTOL MYERS SQUIBB TRIPLE SULFA ALPHARMA US PHARMS TRIPLE SULFAS LEDERLE TABLET; ORAL NEOTRIZINE LILLY SULFALOID FOREST PHARMS SULFA-TRIPLE #2 IMPAX LABS SULFOSE WYETH AYERST TERFONYL BRISTOL MYERS SQUIBB TRIPLE SULFA PUREPAC PHARM TRIPLE SULFAS LEDERLE

167MG/5ML;167MG/5ML;167MG/5ML 167MG/5ML;167MG/5ML;167MG/5ML 167MG/5ML;167MG/5ML;167MG/5ML 167MG/5ML;167MG/5ML;167MG/5ML 167MG/5ML;167MG/5ML;167MG/5ML 167MG/5ML;167MG/5ML;167MG/5ML 167MG/5ML;167MG/5ML;167MG/5ML

A080123 N006317 A080100 A080013 N006904 A080280 N006920

002 012 001 002 002 001 003

167MG;167MG;167MG 167MG;167MG;167MG 167MG;167MG;167MG 167MG;167MG;167MG 167MG;167MG;167MG 167MG;167MG;167MG 167MG;167MG;167MG

N006317 A080099 A080079 A080013 N006904 A080086 N006920

011 001 001 001 001 001 002

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TRISULFAPYRIMIDINES (SULFADIAZINE;SULFAMERAZINE;SULFAMETHAZINE)
TABLET; ORAL TRIPLE SULFOID PAL PAK

6 - 338 (of 346)

167MG;167MG;167MG

A080094

001

TROGLITAZONE
TABLET; ORAL PRELAY SANKYO

200MG 300MG 400MG 200MG 300MG 400MG

N020719 N020719 N020719 N020720 N020720 N020720

001 003 002 001 003 002

Jan 29, 1997 Aug 04, 1997 Jan 29, 1997 Jan 29, 1997 Aug 04, 1997 Jan 29, 1997

REZULIN PFIZER PHARMS

TROLAMINE POLYPEPTIDE OLEATE CONDENSATE

SOLUTION/DROPS; OTIC CERUMENEX PHARM RES ASSOC

10%

N011340

002

TROLEANDOMYCIN
CAPSULE; ORAL TAO PFIZER SUSPENSION; ORAL TAO PFIZER

EQ 250MG BASE

N050336

002

EQ 125MG BASE/5ML

N050332

001

TROPICAMIDE
SOLUTION/DROPS; OPHTHALMIC MYDRIACYL ALCON 0.5% 1% MYDRIAFAIR PHARMAFAIR 0.5% 1% TROPICAMIDE AKORN 1% ALCON UNIVERSAL 1% MIZA PHARMS USA 0.5% 1% WATSON LABS 0.5%

N012111 N012111 A088274 A088230 A088447 A089172 A087636 A087637 A089171

002 004 001 001 001 001 001 001 001 Sep 16, 1983 Sep 16, 1983 Aug Dec Jul Aug Dec 28, 28, 30, 09, 28, 1985 1990 1982 1982 1990

TROVAFLOXACIN MESYLATE
TABLET; ORAL TROVAN PFIZER

EQ 100MG BASE EQ 200MG BASE

N020759 N020759

001 002

Dec 18, 1997 Dec 18, 1997

TUBOCURARINE CHLORIDE
INJECTABLE; INJECTION TUBOCURARINE CHLORIDE BRISTOL MYERS SQUIBB HOSPIRA LILLY

3MG/ML 3MG/ML 3MG/ML

N005657 N006095 N006325

001 001 001

TYROPANOATE SODIUM
CAPSULE; ORAL BILOPAQUE GE HEALTHCARE

750MG

N013731

001

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UNOPROSTONE ISOPROPYL
SOLUTION/DROPS; OPHTHALMIC RESCULA SUCAMPO PHARMS 0.15%

6 - 339 (of 346)

N021214

001

Aug 03, 2000

URACIL MUSTARD
CAPSULE; ORAL URACIL MUSTARD SHIRE

1MG

N012892

001

UREA
INJECTABLE; INJECTION STERILE UREA HOSPIRA UREAPHIL HOSPIRA

40GM/VIAL 40GM/VIAL

N017698 N012154

001 001

UREA C-13
FOR SOLUTION; ORAL HELICOSOL METABOLIC SOLUTIONS 125MG/VIAL MERETEK UBT KIT (W/ PRANACTIN) OTSUKA AMERICA 125MG/VIAL PYLORI-CHEK BREATH TEST DXS DEVICES 100MG/VIAL

N021092 N020586 N020900

001 001 001

Dec 17, 1999 Sep 17, 1996 Feb 04, 1999

UROFOLLITROPIN
INJECTABLE; INTRAMUSCULAR METRODIN SERONO 75 IU/AMP 150 IU/AMP INJECTABLE; SUBCUTANEOUS FERTINEX SERONO 75 IU/AMP 150 IU/AMP

N019415 N019415

002 003

Sep 18, 1986 Sep 18, 1986

N019415 N019415

005 004

Aug 23, 1996 Aug 23, 1996

UROKINASE
INJECTABLE; INJECTION KINLYTIC MICROBIX BIOSYSTEMS

5,000 IU/VIAL 9,000 IU/VIAL 250,000 IU/VIAL

N021846 N021846 N021846

003 002 001

URSODIOL
CAPSULE; ORAL ACTIGALL WATSON PHARMS

150MG

N019594

001

Dec 31, 1987

VALDECOXIB
TABLET; ORAL BEXTRA GD SEARLE

10MG 20MG

N021341 N021341

002 003

Nov 16, 2001 Nov 16, 2001

VALPROIC ACID
CAPSULE; ORAL VALPROIC ACID PAR PHARM SCHERER RP USL PHARMA SYRUP; ORAL VALPROIC ACID APOTEX INC

250MG 250MG 250MG

A070431 A070195 A070631

001 001 001

Feb 28, 1986 Jul 02, 1987 Jun 11, 1987

250MG/5ML

A077105

001

Jul 29, 2005

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VALSARTAN
CAPSULE; ORAL DIOVAN NOVARTIS

6 - 340 (of 346)

80MG 160MG

N020665 N020665

001 002

Dec 23, 1996

Dec 23, 1996

VANCOMYCIN HYDROCHLORIDE
FOR SOLUTION; ORAL VANCOCIN HYDROCHLORIDE VIROPHARMA VANCOLED LEDERLE INJECTABLE; INJECTION VANCOCIN HYDROCHLORIDE VIROPHARMA

EQ 250MG BASE/5ML EQ 500MG BASE/6ML EQ 250MG BASE/5ML EQ 500MG BASE/6ML

A061667 A061667 A063321 A063321

002 001 002 003

Jul 13, 1983

Oct 15, 1993

Oct 15, 1993

EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ

500MG BASE/VIAL 500MG BASE/VIAL 500MG BASE/VIAL 500MG BASE/VIAL 1GM BASE/VIAL 1GM BASE/VIAL 1GM BASE/VIAL 1GM BASE/VIAL 10GM BASE/VIAL 500MG BASE/VIAL 1GM BASE/VIAL 2GM BASE/VIAL 5GM BASE/VIAL 10GM BASE/VIAL 500MG BASE/VIAL 1GM BASE/VIAL 500MG BASE/VIAL 1GM BASE/VIAL

A060180 A062476 A062716 A062812 A060180 A062476 A062716 A062812 A062812 A062682 A062682 A062682 A062682 A062682 A062879 A062879 A062956 A062956

001 001 001 001 002 002 002 002 003 001 002 003 004 005 001 002 001 002

Mar Mar Nov Mar Mar Mar Nov Nov Jul Mar May May May

15, 13, 17, 21, 21, 13, 17, 17, 22, 30, 11, 11, 11,

1984 1987 1987 1986 1986 1987 1987 1987 1986 1988 1988 1988 1988

VANCOLED BAXTER HLTHCARE

VANCOMYCIN HYDROCHLORIDE BAXTER HLTHCARE EQ EQ VANCOR PHARMACIA AND UPJOHN EQ EQ

Aug 02, 1988 Aug 02, 1988 Aug 01, 1988 Aug 01, 1988

VASOPRESSIN TANNATE
INJECTABLE; INJECTION PITRESSIN TANNATE PARKE DAVIS

5PRESSOR UNITS/ML

N003402

001

VECURONIUM BROMIDE
INJECTABLE; INJECTION NORCURON ORGANON USA INC VECURONIUM BROMIDE BAXTER HLTHCARE HOSPIRA

10MG/VIAL 20MG/VIAL 10MG/VIAL 20MG/VIAL 4MG/VIAL

N018776 N018776 A075218 A075218 A075558

002 003 001 002 001

Apr 30, 1984 Jan 03, 1992 Aug 23, 1999 Aug 23, 1999 Sep 11, 2001

VELAGLUCERASE ALFA
POWDER; IV (INFUSION) VPRIV SHIRE HUMAN GENETIC

200 UNITS/VIAL

N022575

002

Feb 26, 2010

VENLAFAXINE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL EFFEXOR XR WYETH PHARMS INC EQ 100MG BASE

N020699

003

Oct 20, 1997

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

VENLAFAXINE HYDROCHLORIDE
TABLET; ORAL EFFEXOR WYETH PHARMS INC

6 - 341 (of 346)

EQ EQ EQ EQ EQ EQ VENLAFAXINE HYDROCHLORIDE PLIVA HRVATSKA DOO EQ EQ EQ EQ EQ SANDOZ EQ EQ EQ EQ EQ

12.5MG BASE 25MG BASE 37.5MG BASE 50MG BASE 75MG BASE 100MG BASE 25MG BASE 37.5MG BASE 50MG BASE 75MG BASE 100MG BASE 25MG BASE 37.5MG BASE 50MG BASE 75MG BASE 100MG BASE

N020151 N020151 N020151 N020151 N020151 N020151 A078517 A078517 A078517 A078517 A078517 A077515 A077515 A077515 A077515 A077515

001 002 006 003 004 005 001 002 003 004 005 001 002 003 004 005

Dec Dec Dec Dec Dec Dec Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun

28, 28, 28, 28, 28, 28, 13, 13, 13, 13, 13, 13, 13, 13, 13, 13,

1993 1993 1993 1993 1993 1993 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008

VERAPAMIL HYDROCHLORIDE
INJECTABLE; INJECTION CALAN GD SEARLE LLC

2.5MG/ML 2.5MG/ML

N018925 N019038 N018485 A070348 A072888 A070577 A070739 A070740 A070225 A070617 A072233 A073485 A070696 A070697 A070695

001 001 001 001 001 001 001 001 001 001 001 001 001 001 001

Mar 30, 1984 Mar 30, 1984

ISOPTIN FSC 2.5MG/ML VERAPAMIL HYDROCHLORIDE ABRAXIS PHARM 2.5MG/ML BEDFORD 2.5MG/ML HOSPIRA 2.5MG/ML 2.5MG/ML 2.5MG/ML LUITPOLD 2.5MG/ML 2.5MG/ML MARSAM PHARMS LLC 2.5MG/ML 2.5MG/ML SMITH AND NEPHEW 2.5MG/ML 2.5MG/ML SOLOPAK 2.5MG/ML TABLET; ORAL CALAN GD SEARLE LLC 160MG ISOPTIN FSC 40MG 80MG 120MG VERAPAMIL HYDROCHLORIDE ACTAVIS ELIZABETH 80MG 120MG HERITAGE PHARMS INC 80MG 120MG MUTUAL PHARM 80MG 80MG 120MG 120MG PLIVA 40MG 80MG 120MG SANDOZ 40MG 80MG 120MG

May Jul Feb May May Nov Nov Feb Sep Jul Jul Jul

01, 28, 02, 06, 06, 12, 12, 26, 27, 31, 31, 31,

1986 1995 1987 1987 1987 1985 1985 1993 1993 1987 1987 1987

N018817 N018593 N018593 N018593 A071019 A070468 A071880 A071881 A070482 A071489 A070483 A071489 A072751 A072124 A072125 A073168 A071423 A071424

004 003 001 002 001 001 001 001 001 002 001 001 001 001 001 001 001 001

Feb 23, 1988 Nov 23, 1987 Mar 08, 1982 Mar 08, 1982 Sep Sep Apr Apr Sep Jan Sep Jan Feb Jan Jan Jul May May 24, 24, 05, 05, 24, 13, 24, 13, 23, 26, 26, 31, 24, 25, 1986 1986 1988 1988 1986 1988 1986 1988 1996 1989 1989 1992 1988 1988

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

VERAPAMIL HYDROCHLORIDE
TABLET; ORAL VERAPAMIL HYDROCHLORIDE WARNER CHILCOTT 80MG 120MG WATSON LABS 40MG TABLET, EXTENDED RELEASE; ORAL VERAPAMIL HYDROCHLORIDE PLIVA 240MG

6 - 342 (of 346)

A070340 A070341 A072799

001 001 001

Sep 24, 1986 Sep 24, 1986 Apr 28, 1989

A072922

001

Mar 01, 1996

VERATRUM VIRIDE ROOT

TABLET; ORAL VERTAVIS MEDPOINTE PHARM HLC

130CSR UNIT

N005691

002

VIDARABINE
INJECTABLE; INJECTION VIRA-A PARKEDALE OINTMENT; OPHTHALMIC VIRA-A PARKEDALE

EQ 187.4MG BASE/ML

N050523

001

3%

N050486

001

VINBLASTINE SULFATE
INJECTABLE; INJECTION VELBAN LILLY VINBLASTINE SULFATE ABRAXIS PHARM HOSPIRA

10MG/VIAL 10MG/VIAL 10MG/VIAL

N012665 A089011 A089565

001 001 001 Nov 18, 1985 Aug 18, 1987

VINCRISTINE SULFATE
INJECTABLE; INJECTION ONCOVIN LILLY

1MG/VIAL 1MG/ML 5MG/VIAL 1MG/ML 5MG/VIAL 1MG/ML 1MG/ML 1MG/ML 1MG/ML 1MG/VIAL 2MG/VIAL 5MG/VIAL

N014103 N014103 N014103 A071426 A070867 A070873 A070411 A076296 A076401 A071559 A071560 A071561

001 003 002 001 001 001 001 001 001 001 001 001

Mar 07, 1984

VINCASAR PFS TEVA PARENTERAL VINCREX BRISTOL MYERS SQUIBB VINCRISTINE SULFATE ABIC ABRAXIS PHARM APP PHARMS HOSPIRA

Jul 17, 1987 Jul 12, 1988 Feb Sep Dec Oct Apr Apr Apr 19, 10, 20, 28, 11, 11, 11, 1987 1986 2002 2003 1988 1988 1988

VIOMYCIN SULFATE
INJECTABLE; INJECTION VIOCIN SULFATE PFIZER

EQ 1GM BASE/VIAL EQ 5GM BASE/VIAL

A061086 A061086

001 002

VITAMIN A
CAPSULE; ORAL AQUASOL A ASTRAZENECA VITAMIN A BANNER PHARMACAPS

25,000USP UNITS 50,000USP UNITS 50,000USP UNITS

A083080 A083080 A083973

002 001 001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

VITAMIN A
CAPSULE; ORAL VITAMIN A CHASE CHEM EVERYLIFE IMPAX LABS WEST WARD

6 - 343 (of 346)

50,000 IU 50,000 IU 50,000USP UNITS 50,000USP UNITS

A083351 A083134 A080952 A080985

001 001 001 001

VITAMIN A PALMITATE
CAPSULE; ORAL AFAXIN STERLING WINTHROP ALPHALIN LILLY DEL-VI-A DEL RAY LABS VI-DOM-A BAYER PHARMS VITAMIN A BANNER PHARMACAPS BRISTOL MYERS SQUIBB CHASE CHEM ELKINS SINN EVERYLIFE IMPAX LABS IVAX SUB TEVA PHARMS MK LABS WEST WARD WHARTON LABS VITAMIN A PALMITATE ARCUM BANNER PHARMACAPS VITAMIN A SOLUBILIZED TEVA INJECTABLE; INJECTION VITAMIN A PALMITATE BEL MAR

EQ 50,000 UNITS BASE EQ 50,000 UNITS BASE EQ 50,000 UNITS BASE EQ 50,000 UNITS BASE EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ EQ 50,000 50,000 50,000 50,000 50,000 50,000 50,000 50,000 50,000 50,000 50,000 25,000 50,000 50,000 50,000 50,000 50,000 50,000 50,000 UNITS UNITS UNITS UNITS UNITS UNITS UNITS UNITS UNITS UNITS UNITS UNITS UNITS UNITS UNITS UNITS UNITS UNITS UNITS BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE BASE

A083187 A080883 A080830 A080972 A080702 A080860 A080746 A083207 A085479 A080943 A083114 A080953 A080955 A083035 A083190 A083457 A083457 A080967 A083665 A083311 A083321 A083948 A083981 A080921

001 001 001 001 001 001 001 001 001 001 001 001 001 001 001 002 001 001 001 001 001 001 001 001

EQ 50,000 UNITS BASE

EQ 50,000 UNITS BASE/ML

A080819

001

WARFARIN POTASSIUM
TABLET; ORAL ATHROMBIN-K PHARM RES ASSOC

2MG 5MG 10MG 25MG

N011771 N011771 N011771 N011771

007 004 005 006

WARFARIN SODIUM
INJECTABLE; INJECTION COUMADIN BRISTOL MYERS SQUIBB TABLET; ORAL ATHROMBIN PHARM RES ASSOC

50MG/VIAL 75MG/VIAL

N009218 N009218

020 012

5MG 10MG 25MG

N011771 N011771 N011771

003 002 001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

WARFARIN SODIUM
TABLET; ORAL PANWARFIN ABBOTT

6 - 344 (of 346)

2MG 2.5MG 5MG 7.5MG 10MG 1MG 2MG 2.5MG 3MG 4MG 5MG 6MG 7.5MG 10MG 2MG 2.5MG 5MG 2MG 2.5MG 5MG 7.5MG 10MG

N017020 N017020 N017020 N017020 N017020 A040196 A040196 A040196 A040196 A040196 A040196 A040196 A040196 A040196 A088719 A088720 A088721 A086123 A086120 A086119 A086118 A086122

001 002 003 004 005 001 002 003 008 004 005 009 006 007 001 001 001 001 001 001 001 001 Sep Sep Sep Jul Sep Sep Jul Sep Sep Jun Aug Jul Aug Aug Aug Aug Aug 30, 30, 30, 26, 30, 30, 26, 30, 30, 27, 06, 02, 17, 17, 17, 17, 17, 1997 1997 1997 2000 1997 1997 2000 1997 1997 1985 1985 1985 1982 1982 1982 1982 1982

WARFARIN SODIUM SANDOZ

USL PHARMA

WATSON LABS

XENON XE-127
GAS; INHALATION XENON XE 127 MALLINCKRODT

5mCi/VIAL 10mCi/VIAL

N018536 N018536

001 002

Oct 01, 1982 Oct 01, 1982

XENON XE-133
GAS; INHALATION XENON XE 133 GE HEALTHCARE

GEN ELECTRIC MALLINCKRODT

1 CI/AMP 10mCi/VIAL 20mCi/VIAL 5-100 CI/CYLINDER 0.25-5 CI/AMP 10mCi/VIAL 20mCi/VIAL

N017256 N017687 N017687 N017550 N017550 N018327 N018327 N017687

002 002 003 001 003 001 002 001

Mar 09, 1982 Mar 09, 1982

XENON XE 133-V.S.S. GE HEALTHCARE 10mCi/VIAL INJECTABLE; INJECTION XENON XE 133 GE HEALTHCARE 1.3-1.7 CI/AMP LANTHEUS MEDCL 6.3mCi/ML SOLUTION; INHALATION, INJECTION XENEISOL MALLINCKRODT 18-25mCi/AMP

N017256 N017283

001 001

N017262

002

XYLOSE
POWDER; ORAL XYLO-PFAN SAVAGE LABS XYLOSE LYNE

25GM/BOT 25GM/BOT

N017605 N018856

001 001 Mar 26, 1987

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

ZALCITABINE
TABLET; ORAL HIVID ROCHE

6 - 345 (of 346)

0.375MG 0.75MG

N020199 N020199

001 002

Jun 19, 1992 Jun 19, 1992

ZALEPLON
CAPSULE; ORAL ZALEPLON SANDOZ

5MG 10MG

A078095 A078095

001 002

Jun 06, 2008 Jun 06, 2008

ZICONOTIDE
INJECTABLE; INTRATHECAL PRIALT AZUR PHARMA II

200MCG/2ML (100MCG/ML)

N021060

003

Dec 28, 2004

ZIDOVUDINE
TABLET; ORAL RETROVIR VIIV HLTHCARE ZIDOVUDINE AUROBINDO PHARMA MATRIX LABS LTD

200MG 60MG 100MG

N020518 N022294 N200732

001 001 001

Dec 19, 1995 Jul 23, 2009 Feb 23, 2011

ZILEUTON
TABLET; ORAL ZYFLO CORNERSTONE THERAP

300MG

N020471

001

Dec 09, 1996

ZINC SULFATE
INJECTABLE; INJECTION ZINC SULFATE ABRAXIS PHARM

EQ 1MG ZINC/ML

N019229

002

May 05, 1987

ZOLEDRONIC ACID
INJECTABLE; IV (INFUSION) ZOMETA NOVARTIS EQ 4MG BASE/VIAL

N021223

001

Aug 20, 2001

ZOLPIDEM TARTRATE
TABLET; ORAL ZOLPIDEM TARTRATE MUTUAL PHARMA

5MG 10MG SYNTHON PHARMS 5MG 10MG WORLD GEN 5MG 10MG TABLET, ORALLY DISINTEGRATING; ORAL TOVALT ODT BIOVAIL LABS INTL 5MG 10MG

A077288 A077288 A077540 A077540 A076062 A076062

001 002 001 002 001 002

Apr Apr Apr Apr Apr Apr

23, 23, 23, 23, 23, 23,

2007 2007 2007 2007 2007 2007

N021412 N021412

001 002

Apr 25, 2007 Apr 25, 2007

ZONISAMIDE
CAPSULE; ORAL ZONISAMIDE MUTUAL PHARM

ROXANE

25MG 50MG 100MG 25MG 50MG 100MG

A077635 A077635 A077635 A077648 A077648 A077648

001 002 003 001 002 003

Dec Dec Dec Dec Dec Dec

22, 22, 22, 22, 22, 22,

2005 2005 2005 2005 2005 2005

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

ZONISAMIDE
CAPSULE; ORAL ZONISAMIDE TEVA PHARMS

6 - 346 (of 346)

WATSON LABS

25MG 50MG 100MG 25MG 50MG 100MG

A077641 A077641 A077641 A077650 A077650 A077650

003 002 001 001 002 003

Dec Dec Dec Apr Apr Apr

22, 22, 22, 20, 20, 20,

2005 2005 2005 2006 2006 2006

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

7-1

ORPHAN PRODUCT DESIGNATIONS AND APPROVALS LIST

The list of List of Orphan Designations and Approvals is available at:

http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/def

ault.htm

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

8-1

DRUG PRODUCTS WHICH MUST DEMONSTRATE IN VIVO BIOAVAILABILITY

ONLY IF PRODUCT FAILS TO ACHIEVE ADEQUATE DISSOLUTION

ACETAMINOPHEN; ASPIRIN; BUTALBITAL CAPSULE OR TABLET; ORAL 160-165MG; 160-165MG; 50MG ACETAMINOPHEN; ASPIRIN; BUTALBITAL CAPSULE OR TABLET; ORAL 325MG; 325MG; 50MG ACETAMINOPHEN; ASPIRIN; BUTALBITAL; CAFFEINE CAPSULE OR TABLET; ORAL 160-165MG; 160-165MG; 50MG; 40MG ACETAMINOPHEN; ASPIRIN; BUTALBITAL; CAFFEINE CAPSULE OR TABLET; ORAL 325MG; 325MG; 50MG; 40MG ACETAMINOPHEN; BUTALBITAL CAPSULE OR TABLET; ORAL 325MG; 50MG 650MG; 50MG ACETAMINOPHEN; BUTALBITAL; CAFFEINE CAPSULE OR TABLET; ORAL 325MG; 50MG; 40MG 650MG; 50MG; 40MG 500MG; 50MG; 40MG AMINOPHYLLINE TABLET; ORAL 100MG; 200MG ASPIRIN; BUTALBITAL CAPSULE OR TABLET; ORAL 325MG; 50MG 650MG; 50MG ASPIRIN; BUTALBITAL; CAFFEINE CAPSULE OR TABLET; ORAL 325MG; 50MG; 40MG 650MG; 50MG; 40MG

ASPIRIN; CAFFEINE; CARISOPRODOL TABLET; ORAL 160MG; 32MG; 200MG ASPIRIN; CAFFEINE; CARISOPRODOL; CODEINE PHOSPHATE TABLET; ORAL 160MG; 32MG; 200MG; 16MG ASPIRIN; CARISOPRODOL TABLET; ORAL 325MG; 200MG ASPIRIN; CARISOPRODOL; CODEINE PHOSPHATE TABLET; ORAL 325MG; 200MG; 16MG ASPIRIN; MEPROBAMATE TABLET; ORAL 325MG; 200MG ASPIRIN; METHOCARBAMOL TABLET; ORAL 325MG; 400MG CHLOROTHIAZIDE TABLET; ORAL 250MG HYDROXYZINE HYDROCHLORIDE TABLET; ORAL 10MG; 25MG; 50MG; 100MG PREDNISONE TABLET; ORAL 1MG; 2.5MG; 5MG; 10MG; 20MG; 25MG; 50MG

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

**

PRODUCT NAME INDEX

**

A - 1

OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN, AMOXICILLIN

**
8-MOP, METHOXSALEN

**

**

**

ABELCET, AMPHOTERICIN B ABILIFY, ARIPIPRAZOLE ABLAVAR, GADOFOSVESET TRISODIUM ABRAXANE, PACLITAXEL ABREVA, DOCOSANOL (OTC) ABSTRAL, FENTANYL CITRATE ACANYA, BENZOYL PEROXIDE ACARBOSE, ACARBOSE ACCOLATE, ZAFIRLUKAST ACCUNEB, ALBUTEROL SULFATE ACCUPRIL, QUINAPRIL HYDROCHLORIDE ACCURETIC, HYDROCHLOROTHIAZIDE ACEBUTOLOL HYDROCHLORIDE, ACEBUTOLOL HYDROCHLORIDE ACEON, PERINDOPRIL ERBUMINE ACEPHEN, ACETAMINOPHEN (OTC) ACETADOTE, ACETYLCYSTEINE ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE, ACETAMINOPHEN ACETAMINOPHEN, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN AND CAFFEINE, ACETAMINOPHEN (OTC) ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE, ACETAMINOPHEN ACETASOL HC, ACETIC ACID, GLACIAL ACETAZOLAMIDE SODIUM, ACETAZOLAMIDE SODIUM ACETAZOLAMIDE, ACETAZOLAMIDE ACETIC ACID 0.25% IN PLASTIC CONTAINER, ACETIC ACID, GLACIAL ACETIC ACID 2% IN AQUEOUS ALUMINUM ACETATE, ACETIC ACID, GLACIAL ACETIC ACID, ACETIC ACID, GLACIAL ACETOHEXAMIDE, ACETOHEXAMIDE ACETYLCYSTEINE, ACETYLCYSTEINE ACIPHEX, RABEPRAZOLE SODIUM ACLOVATE, ALCLOMETASONE DIPROPIONATE ACTHREL, CORTICORELIN OVINE TRIFLUTATE ACTIGALL, URSODIOL ACTIQ, FENTANYL CITRATE ACTIVELLA, ESTRADIOL ACTONEL, RISEDRONATE SODIUM ACTOPLUS MET XR, METFORMIN HYDROCHLORIDE ACTOPLUS MET, METFORMIN HYDROCHLORIDE ACTOS, PIOGLITAZONE HYDROCHLORIDE ACULAR LS, KETOROLAC TROMETHAMINE ACULAR PRESERVATIVE FREE, KETOROLAC TROMETHAMINE ACULAR, KETOROLAC TROMETHAMINE ACUVAIL, KETOROLAC TROMETHAMINE ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE, ACYCLOVIR SODIUM ACYCLOVIR SODIUM, ACYCLOVIR SODIUM ACYCLOVIR, ACYCLOVIR ACZONE, DAPSONE ADAGEN, PEGADEMASE BOVINE ADALAT CC, NIFEDIPINE ADAPALENE, ADAPALENE ADCIRCA, TADALAFIL ADDERALL XR 10, AMPHETAMINE ASPARTATE ADDERALL XR 15, AMPHETAMINE ASPARTATE ADDERALL XR 20, AMPHETAMINE ASPARTATE ADDERALL XR 25, AMPHETAMINE ASPARTATE ADDERALL XR 30, AMPHETAMINE ASPARTATE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

**

PRODUCT NAME INDEX

A **

A - 2

ADDERALL XR 5, AMPHETAMINE ASPARTATE ADENOCARD, ADENOSINE ADENOSCAN, ADENOSINE ADENOSINE, ADENOSINE ADIPEX-P, PHENTERMINE HYDROCHLORIDE ADRENACLICK, EPINEPHRINE ADREVIEW, IOBENGUANE SULFATE I-123 ADVAIR DISKUS 100/50, FLUTICASONE PROPIONATE ADVAIR DISKUS 250/50, FLUTICASONE PROPIONATE ADVAIR DISKUS 500/50, FLUTICASONE PROPIONATE ADVAIR HFA, FLUTICASONE PROPIONATE ADVICOR, LOVASTATIN ADVIL ALLERGY AND CONGESTION RELIEF, CHLORPHENIRAMINE MALEATE ADVIL ALLERGY SINUS, CHLORPHENIRAMINE MALEATE (OTC) ADVIL COLD AND SINUS, IBUPROFEN (OTC) ADVIL CONGESTION RELIEF, IBUPROFEN (OTC) ADVIL LIQUI-GELS, IBUPROFEN (OTC) ADVIL MIGRAINE LIQUI-GELS, IBUPROFEN (OTC) ADVIL PM, DIPHENHYDRAMINE CITRATE (OTC) ADVIL PM, DIPHENHYDRAMINE HYDROCHLORIDE (OTC) ADVIL, IBUPROFEN (OTC) AEROBID, FLUNISOLIDE AEROSPAN HFA, FLUNISOLIDE AFEDITAB CR, NIFEDIPINE AFINITOR, EVEROLIMUS AFRINOL, PSEUDOEPHEDRINE SULFATE (OTC) AGGRASTAT, TIROFIBAN HYDROCHLORIDE AGGRENOX, ASPIRIN AGRYLIN, ANAGRELIDE HYDROCHLORIDE A-HYDROCORT, HYDROCORTISONE SODIUM SUCCINATE AKBETA, LEVOBUNOLOL HYDROCHLORIDE AK-FLUOR 10%, FLUORESCEIN SODIUM AKINETON, BIPERIDEN HYDROCHLORIDE AKNE-MYCIN, ERYTHROMYCIN AKPENTOLATE, CYCLOPENTOLATE HYDROCHLORIDE AKPRO, DIPIVEFRIN HYDROCHLORIDE AKTEN, LIDOCAINE HYDROCHLORIDE AKTOB, TOBRAMYCIN ALA-CORT, HYDROCORTISONE ALAMAST, PEMIROLAST POTASSIUM ALA-SCALP, HYDROCORTISONE ALAVERT, LORATADINE (OTC) ALAWAY, KETOTIFEN FUMARATE (OTC) ALBALON, NAPHAZOLINE HYDROCHLORIDE ALBENZA, ALBENDAZOLE ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE ALBUTEROL SULFATE, ALBUTEROL SULFATE ALCAINE, PROPARACAINE HYDROCHLORIDE ALCLOMETASONE DIPROPIONATE, ALCLOMETASONE DIPROPIONATE ALCOHOL 10% AND DEXTROSE 5%, ALCOHOL ALCOHOL 5% AND DEXTROSE 5%, ALCOHOL ALDACTAZIDE, HYDROCHLOROTHIAZIDE ALDACTONE, SPIRONOLACTONE ALDARA, IMIQUIMOD ALENDRONATE SODIUM, ALENDRONATE SODIUM ALEVE, NAPROXEN SODIUM (OTC) ALEVE-D SINUS & COLD, NAPROXEN SODIUM (OTC) ALFENTA, ALFENTANIL HYDROCHLORIDE ALFENTANIL, ALFENTANIL HYDROCHLORIDE ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE ALIMTA, PEMETREXED DISODIUM ALINIA, NITAZOXANIDE ALKERAN, MELPHALAN

(OTC)

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

**

PRODUCT NAME INDEX

A **

A - 3

ALKERAN, MELPHALAN HYDROCHLORIDE ALLEGRA ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC) ALLEGRA HIVES, FEXOFENADINE HYDROCHLORIDE (OTC) ALLEGRA, FEXOFENADINE HYDROCHLORIDE ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION, FEXOFENADINE HYDROCHLORIDE (OTC) ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION, FEXOFENADINE HYDROCHLORIDE (OTC) ALLI, ORLISTAT (OTC) ALLOPURINOL SODIUM, ALLOPURINOL SODIUM ALLOPURINOL, ALLOPURINOL ALOCRIL, NEDOCROMIL SODIUM ALOMIDE, LODOXAMIDE TROMETHAMINE ALOPRIM, ALLOPURINOL SODIUM ALORA, ESTRADIOL ALOXI, PALONOSETRON HYDROCHLORIDE ALPHAGAN P, BRIMONIDINE TARTRATE ALPRAZOLAM, ALPRAZOLAM ALPROSTADIL, ALPROSTADIL ALREX, LOTEPREDNOL ETABONATE ALSUMA, SUMATRIPTAN SUCCINATE ALTABAX, RETAPAMULIN ALTACE, RAMIPRIL ALTAVERA, ETHINYL ESTRADIOL ALTOPREV, LOVASTATIN ALVESCO, CICLESONIDE AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE AMARYL, GLIMEPIRIDE AMBIEN CR, ZOLPIDEM TARTRATE AMBIEN, ZOLPIDEM TARTRATE AMBISOME, AMPHOTERICIN B AMCINONIDE, AMCINONIDE AMERGE, NARATRIPTAN HYDROCHLORIDE A-METHAPRED, METHYLPREDNISOLONE SODIUM SUCCINATE AMICAR, AMINOCAPROIC ACID AMIDATE, ETOMIDATE AMIFOSTINE, AMIFOSTINE AMIKACIN SULFATE, AMIKACIN SULFATE AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, AMILORIDE HYDROCHLORIDE AMILORIDE HYDROCHLORIDE, AMILORIDE HYDROCHLORIDE AMINOACETIC ACID 1.5% IN PLASTIC CONTAINER, GLYCINE AMINOCAPROIC ACID IN PLASTIC CONTAINER, AMINOCAPROIC ACID AMINOCAPROIC ACID, AMINOCAPROIC ACID AMINOCAPROIC, AMINOCAPROIC ACID AMINOHIPPURATE SODIUM, AMINOHIPPURATE SODIUM AMINOPHYLLINE, AMINOPHYLLINE AMINOSYN 10% (PH6), AMINO ACIDS AMINOSYN 10%, AMINO ACIDS AMINOSYN 3.5% M, AMINO ACIDS AMINOSYN 3.5%, AMINO ACIDS AMINOSYN 5%, AMINO ACIDS AMINOSYN 7% (PH6), AMINO ACIDS AMINOSYN 7% W/ ELECTROLYTES, AMINO ACIDS AMINOSYN 7%, AMINO ACIDS AMINOSYN 8.5% (PH6), AMINO ACIDS AMINOSYN 8.5% W/ ELECTROLYTES, AMINO ACIDS AMINOSYN 8.5%, AMINO ACIDS AMINOSYN II 10% IN PLASTIC CONTAINER, AMINO ACIDS AMINOSYN II 10% W/ ELECTROLYTES, AMINO ACIDS AMINOSYN II 10%, AMINO ACIDS AMINOSYN II 15% IN PLASTIC CONTAINER, AMINO ACIDS AMINOSYN II 7%, AMINO ACIDS AMINOSYN II 8.5% W/ ELECTROLYTES, AMINO ACIDS AMINOSYN II 8.5%, AMINO ACIDS AMINOSYN-HBC 7%, AMINO ACIDS

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

**

PRODUCT NAME INDEX

A **

A - 4

AMINOSYN-HF 8%, AMINO ACIDS AMINOSYN-PF 10%, AMINO ACIDS AMINOSYN-PF 7%, AMINO ACIDS AMINOSYN-RF 5.2%, AMINO ACIDS AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE AMITIZA, LUBIPROSTONE AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE AMLODIPINE BESYLATE, AMLODIPINE BESYLATE AMMONIA N 13, AMMONIA, N-13 AMMONIUM CHLORIDE IN PLASTIC CONTAINER, AMMONIUM CHLORIDE AMMONIUM LACTATE, AMMONIUM LACTATE AMMONUL, SODIUM BENZOATE AMNESTEEM, ISOTRETINOIN AMOXAPINE, AMOXAPINE AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN AMOXICILLIN PEDIATRIC, AMOXICILLIN AMOXICILLIN, AMOXICILLIN AMOXIL, AMOXICILLIN AMPHADASE, HYALURONIDASE AMPHOTEC, AMPHOTERICIN B AMPHOTERICIN B, AMPHOTERICIN B AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM AMPICILLIN SODIUM, AMPICILLIN SODIUM AMPICILLIN TRIHYDRATE, AMPICILLIN/AMPICILLIN TRIHYDRATE AMPYRA, DALFAMPRIDINE AMRINONE LACTATE, INAMRINONE LACTATE AMRIX, CYCLOBENZAPRINE HYDROCHLORIDE AMTURNIDE, ALISKIREN HEMIFUMARATE ANADROL-50, OXYMETHOLONE ANAFRANIL, CLOMIPRAMINE HYDROCHLORIDE ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE ANAPROX DS, NAPROXEN SODIUM ANAPROX, NAPROXEN SODIUM ANASTROZOLE, ANASTROZOLE ANCEF IN PLASTIC CONTAINER, CEFAZOLIN SODIUM ANCOBON, FLUCYTOSINE ANDRODERM, TESTOSTERONE ANDROGEL, TESTOSTERONE ANDROID 10, METHYLTESTOSTERONE ANDROID 25, METHYLTESTOSTERONE AN-DTPA, TECHNETIUM TC-99M PENTETATE KIT ANECTINE, SUCCINYLCHOLINE CHLORIDE ANESTACON, LIDOCAINE HYDROCHLORIDE ANEXSIA 5/325, ACETAMINOPHEN ANEXSIA 7.5/325, ACETAMINOPHEN ANEXSIA 7.5/650, ACETAMINOPHEN ANEXSIA, ACETAMINOPHEN ANGELIQ, DROSPIRENONE ANGIOMAX, BIVALIRUDIN ANSAID, FLURBIPROFEN AN-SULFUR COLLOID, TECHNETIUM TC-99M SULFUR COLLOID KIT ANTABUSE, DISULFIRAM ANTARA (MICRONIZED), FENOFIBRATE ANTHELIOS 20, AVOBENZONE (OTC) ANTHELIOS 40, AVOBENZONE (OTC) ANTHELIOS SX, AVOBENZONE (OTC) ANTIVERT, MECLIZINE HYDROCHLORIDE ANTIZOL, FOMEPIZOLE ANTUROL, OXYBUTYNIN ANUSOL HC, HYDROCORTISONE ANZEMET, DOLASETRON MESYLATE APHTHASOL, AMLEXANOX

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

**

PRODUCT NAME INDEX

A **

A - 5

APIDRA SOLOSTAR, INSULIN GLULISINE RECOMBINANT APIDRA, INSULIN GLULISINE RECOMBINANT APLENZIN, BUPROPION HYDROBROMIDE APOKYN, APOMORPHINE HYDROCHLORIDE APRACLONIDINE HYDROCHLORIDE, APRACLONIDINE HYDROCHLORIDE APRISO, MESALAMINE APTIVUS, TIPRANAVIR AQUASOL A, VITAMIN A PALMITATE ARALEN, CHLOROQUINE PHOSPHATE ARANELLE, ETHINYL ESTRADIOL ARAVA, LEFLUNOMIDE ARCAPTA NEOHALER, INDACATEROL MALEATE AREDIA, PAMIDRONATE DISODIUM ARESTIN, MINOCYCLINE HYDROCHLORIDE ARGATROBAN IN SODIUM CHLORIDE, ARGATROBAN ARGATROBAN, ARGATROBAN ARICEPT ODT, DONEPEZIL HYDROCHLORIDE ARICEPT, DONEPEZIL HYDROCHLORIDE ARIDOL KIT, MANNITOL ARIMIDEX, ANASTROZOLE ARISTOSPAN, TRIAMCINOLONE HEXACETONIDE ARIXTRA, FONDAPARINUX SODIUM AROMASIN, EXEMESTANE ARRANON, NELARABINE ARTHROTEC, DICLOFENAC SODIUM ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE, ARTICAINE HYDROCHLORIDE ARTICAINE HYDROCHLORIDE WITH EPINEPHRINE, ARTICAINE HYDROCHLORIDE ASACOL HD, MESALAMINE ASACOL, MESALAMINE ASCLERA, POLIDOCANOL ASMANEX TWISTHALER, MOMETASONE FUROATE ASPIRIN AND DIPYRIDAMOLE, ASPIRIN ASTELIN, AZELASTINE HYDROCHLORIDE ASTEPRO, AZELASTINE HYDROCHLORIDE ASTRAMORPH PF, MORPHINE SULFATE ATACAND HCT, CANDESARTAN CILEXETIL ATACAND, CANDESARTAN CILEXETIL ATELVIA, RISEDRONATE SODIUM ATENOLOL AND CHLORTHALIDONE, ATENOLOL ATENOLOL, ATENOLOL ATIVAN, LORAZEPAM ATOMOXETINE HYDROCHLORIDE, ATOMOXETINE HYDROCHLORIDE ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM ATOVAQUONE AND PROGUANIL HYDROCHLORIDE, ATOVAQUONE ATRACURIUM BESYLATE PRESERVATIVE FREE, ATRACURIUM BESYLATE ATRACURIUM BESYLATE, ATRACURIUM BESYLATE ATRALIN, TRETINOIN ATRIDOX, DOXYCYCLINE HYCLATE ATRIPLA, EFAVIRENZ ATROPEN, ATROPINE ATROPINE SULFATE ANSYR PLASTIC SYRINGE, ATROPINE SULFATE ATROVENT HFA, IPRATROPIUM BROMIDE ATROVENT, IPRATROPIUM BROMIDE AUGMENTIN '125', AMOXICILLIN AUGMENTIN '200', AMOXICILLIN AUGMENTIN '250', AMOXICILLIN AUGMENTIN '400', AMOXICILLIN AUGMENTIN '500', AMOXICILLIN AUGMENTIN '875', AMOXICILLIN AUGMENTIN ES-600, AMOXICILLIN AUGMENTIN XR, AMOXICILLIN AVAGARD, ALCOHOL (OTC) AVAGE, TAZAROTENE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

**

PRODUCT NAME INDEX

A **

A - 6

AVALIDE, HYDROCHLOROTHIAZIDE AVANDAMET, METFORMIN HYDROCHLORIDE AVANDARYL, GLIMEPIRIDE AVANDIA, ROSIGLITAZONE MALEATE AVAPRO, IRBESARTAN AVC, SULFANILAMIDE AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER, MOXIFLOXACIN HYDROCHLORIDE AVELOX, MOXIFLOXACIN HYDROCHLORIDE AVENTYL HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE AVIANE-28, ETHINYL ESTRADIOL AVINZA, MORPHINE SULFATE AVITA, TRETINOIN AVODART, DUTASTERIDE AXERT, ALMOTRIPTAN MALATE AXID AR, NIZATIDINE (OTC) AXID, NIZATIDINE AXIRON, TESTOSTERONE AYGESTIN, NORETHINDRONE ACETATE AZACTAM IN PLASTIC CONTAINER, AZTREONAM AZACTAM, AZTREONAM AZASAN, AZATHIOPRINE AZASITE, AZITHROMYCIN AZATHIOPRINE SODIUM, AZATHIOPRINE SODIUM AZATHIOPRINE, AZATHIOPRINE AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE AZELEX, AZELAIC ACID AZILECT, RASAGILINE MESYLATE AZITHROMYCIN, AZITHROMYCIN AZMACORT, TRIAMCINOLONE ACETONIDE AZOPT, BRINZOLAMIDE AZOR, AMLODIPINE BESYLATE AZTREONAM, AZTREONAM AZULFIDINE EN-TABS, SULFASALAZINE AZULFIDINE, SULFASALAZINE

**

**

BACIIM, BACITRACIN BACI-RX, BACITRACIN BACITRACIN ZINC AND POLYMYXIN B SULFATE, BACITRACIN ZINC BACITRACIN, BACITRACIN BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE, BACITRACIN BACLOFEN, BACLOFEN BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION BACTOCILL IN PLASTIC CONTAINER, OXACILLIN SODIUM BACTRIM DS, SULFAMETHOXAZOLE BACTRIM, SULFAMETHOXAZOLE BACTROBAN, MUPIROCIN BACTROBAN, MUPIROCIN CALCIUM BAL, DIMERCAPROL BALANCED SALT, CALCIUM CHLORIDE BALSALAZIDE DISODIUM, BALSALAZIDE DISODIUM BALZIVA-28, ETHINYL ESTRADIOL BANZEL, RUFINAMIDE BARACLUDE, ENTECAVIR BECONASE AQ, BECLOMETHASONE DIPROPIONATE MONOHYDRATE BENADRYL PRESERVATIVE FREE, DIPHENHYDRAMINE HYDROCHLORIDE BENADRYL, DIPHENHYDRAMINE HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE BENICAR HCT, HYDROCHLOROTHIAZIDE BENICAR, OLMESARTAN MEDOXOMIL BENTYL PRESERVATIVE FREE, DICYCLOMINE HYDROCHLORIDE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

**

PRODUCT NAME INDEX

B **

A - 7

BENTYL, DICYCLOMINE HYDROCHLORIDE BENZACLIN, BENZOYL PEROXIDE BENZAMYCIN PAK, BENZOYL PEROXIDE BENZAMYCIN, BENZOYL PEROXIDE BENZONATATE, BENZONATATE BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE BENZTROPINE MESYLATE, BENZTROPINE MESYLATE BEPREVE, BEPOTASTINE BESILATE BESIVANCE, BESIFLOXACIN HYDROCHLORIDE BETADINE, POVIDONE-IODINE BETAGAN, LEVOBUNOLOL HYDROCHLORIDE BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE BETAMETHASONE VALERATE, BETAMETHASONE VALERATE BETAPACE AF, SOTALOL HYDROCHLORIDE BETAPACE, SOTALOL HYDROCHLORIDE BETA-VAL, BETAMETHASONE VALERATE BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE BETIMOL, TIMOLOL BETOPTIC S, BETAXOLOL HYDROCHLORIDE BETOPTIC, BETAXOLOL HYDROCHLORIDE BEYAZ, DROSPIRENONE BIAXIN XL, CLARITHROMYCIN BIAXIN, CLARITHROMYCIN BICALUTAMIDE, BICALUTAMIDE BICILLIN C-R 900/300, PENICILLIN G BENZATHINE BICILLIN C-R, PENICILLIN G BENZATHINE BICILLIN L-A, PENICILLIN G BENZATHINE BICNU, CARMUSTINE BIDIL, HYDRALAZINE HYDROCHLORIDE BILTRICIDE, PRAZIQUANTEL BIOSCRUB, CHLORHEXIDINE GLUCONATE (OTC) BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE, BISOPROLOL FUMARATE BISOPROLOL FUMARATE, BISOPROLOL FUMARATE BLEOMYCIN SULFATE, BLEOMYCIN SULFATE BLEPH-10, SULFACETAMIDE SODIUM BLEPHAMIDE S.O.P., PREDNISOLONE ACETATE BLEPHAMIDE, PREDNISOLONE ACETATE BONIVA, IBANDRONATE SODIUM BONTRIL PDM, PHENDIMETRAZINE TARTRATE BONTRIL, PHENDIMETRAZINE TARTRATE BRANCHAMIN 4% IN PLASTIC CONTAINER, AMINO ACIDS BRAVELLE, UROFOLLITROPIN BREATHTEK UBT FOR H-PYLORI, UREA C-13 BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER, BRETYLIUM TOSYLATE BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER, ESMOLOL HYDROCHLORIDE BREVIBLOC IN PLASTIC CONTAINER, ESMOLOL HYDROCHLORIDE BREVIBLOC, ESMOLOL HYDROCHLORIDE BREVICON 28-DAY, ETHINYL ESTRADIOL BREVITAL SODIUM, METHOHEXITAL SODIUM BRIAN CARE, CHLORHEXIDINE GLUCONATE (OTC) BRIELLYN, ETHINYL ESTRADIOL BRILINTA, TICAGRELOR BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE BROMDAY, BROMFENAC SODIUM BROMFED-DM, BROMPHENIRAMINE MALEATE BROMFENAC SODIUM, BROMFENAC SODIUM BROMOCRIPTINE MESYLATE, BROMOCRIPTINE MESYLATE BRONCHO SALINE, SODIUM CHLORIDE (OTC) BROVANA, ARFORMOTEROL TARTRATE BSS PLUS, CALCIUM CHLORIDE BSS, CALCIUM CHLORIDE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

**

PRODUCT NAME INDEX

B **

A - 8

BUDESONIDE, BUDESONIDE BUMETANIDE, BUMETANIDE BUPHENYL, SODIUM PHENYLBUTYRATE BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE, BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE W/EPINEPHRINE, BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE BUPRENEX, BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE BUSULFEX, BUSULFAN BUTALBITAL AND ACETAMINOPHEN, ACETAMINOPHEN BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE, ACETAMINOPHEN BUTALBITAL, ASPIRIN AND CAFFEINE, ASPIRIN BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE, ASPIRIN BUTAPAP, ACETAMINOPHEN BUTISOL SODIUM, BUTABARBITAL SODIUM BUTORPHANOL TARTRATE PRESERVATIVE FREE, BUTORPHANOL TARTRATE BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE BUTRANS, BUPRENORPHINE BYETTA, EXENATIDE SYNTHETIC BYSTOLIC, NEBIVOLOL HYDROCHLORIDE

**

**

CABERGOLINE, CABERGOLINE CADUET, AMLODIPINE BESYLATE CAFCIT, CAFFEINE CITRATE CAFERGOT, CAFFEINE CAFFEINE CITRATE, CAFFEINE CITRATE CALAN, VERAPAMIL HYDROCHLORIDE CALCIJEX, CALCITRIOL CALCIPOTRIENE, CALCIPOTRIENE CALCITONIN-SALMON, CALCITONIN SALMON CALCITRIOL, CALCITRIOL CALCIUM ACETATE, CALCIUM ACETATE CALCIUM CARBONATE, FAMOTIDINE AND MAGNESIUM HYDROXIDE, CALCIUM CARBONATE CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER, CALCIUM CHLORIDE CALCIUM DISODIUM VERSENATE, EDETATE CALCIUM DISODIUM CALDOLOR, IBUPROFEN CAMBIA, DICLOFENAC POTASSIUM CAMILA, NORETHINDRONE CAMPRAL, ACAMPROSATE CALCIUM CAMPTOSAR, IRINOTECAN HYDROCHLORIDE CANASA, MESALAMINE CANCIDAS, CASPOFUNGIN ACETATE CANTIL, MEPENZOLATE BROMIDE CAPASTAT SULFATE, CAPREOMYCIN SULFATE CAPEX, FLUOCINOLONE ACETONIDE CAPITAL AND CODEINE, ACETAMINOPHEN CAPITAL SOLEIL 15, AVOBENZONE (OTC) CAPOTEN, CAPTOPRIL CAPOZIDE 25/15, CAPTOPRIL CAPOZIDE 25/25, CAPTOPRIL CAPOZIDE 50/15, CAPTOPRIL CAPOZIDE 50/25, CAPTOPRIL CAPTOPRIL AND HYDROCHLOROTHIAZIDE, CAPTOPRIL CAPTOPRIL, CAPTOPRIL CARAC, FLUOROURACIL CARAFATE, SUCRALFATE CARBAGLU, CARGLUMIC ACID CARBAMAZEPINE, CARBAMAZEPINE

(OTC)

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

**

PRODUCT NAME INDEX

C **

A - 9

CARBATROL, CARBAMAZEPINE CARBIDOPA AND LEVODOPA, CARBIDOPA CARBINOXAMINE MALEATE, CARBINOXAMINE MALEATE CARBOCAINE, MEPIVACAINE HYDROCHLORIDE CARBOPLATIN, CARBOPLATIN CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE CARDENE SR, NICARDIPINE HYDROCHLORIDE CARDENE, NICARDIPINE HYDROCHLORIDE CARDIOGEN-82, RUBIDIUM CHLORIDE RB-82 CARDIOLITE, TECHNETIUM TC-99M SESTAMIBI KIT CARDIOPLEGIC IN PLASTIC CONTAINER, CALCIUM CHLORIDE CARDIZEM CD, DILTIAZEM HYDROCHLORIDE CARDIZEM LA, DILTIAZEM HYDROCHLORIDE CARDIZEM, DILTIAZEM HYDROCHLORIDE CARDURA XL, DOXAZOSIN MESYLATE CARDURA, DOXAZOSIN MESYLATE CARISOPRODOL AND ASPIRIN, ASPIRIN CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE, ASPIRIN CARISOPRODOL, CARISOPRODOL CARMOL HC, HYDROCORTISONE ACETATE CARNITOR SF, LEVOCARNITINE CARNITOR, LEVOCARNITINE CARTEOLOL HYDROCHLORIDE, CARTEOLOL HYDROCHLORIDE CARTIA XT, DILTIAZEM HYDROCHLORIDE CARVEDILOL, CARVEDILOL CASODEX, BICALUTAMIDE CATAFLAM, DICLOFENAC POTASSIUM CATAPRES, CLONIDINE HYDROCHLORIDE CATAPRES-TTS-1, CLONIDINE CATAPRES-TTS-2, CLONIDINE CATAPRES-TTS-3, CLONIDINE CAVERJECT IMPULSE, ALPROSTADIL CAVERJECT, ALPROSTADIL CAYSTON, AZTREONAM CEDAX, CEFTIBUTEN DIHYDRATE CEENU, LOMUSTINE CEFACLOR, CEFACLOR CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE CEFAZOLIN AND DEXTROSE, CEFAZOLIN SODIUM CEFAZOLIN SODIUM, CEFAZOLIN SODIUM CEFDINIR, CEFDINIR CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER, CEFEPIME HYDROCHLORIDE CEFEPIME HYDROCHLORIDE, CEFEPIME HYDROCHLORIDE CEFEPIME IN PLASTIC CONTAINER, CEFEPIME HYDROCHLORIDE CEFOTAXIME SODIUM, CEFOTAXIME SODIUM CEFOTAXIME, CEFOTAXIME SODIUM CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER, CEFOTETAN DISODIUM CEFOTETAN, CEFOTETAN DISODIUM CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER, CEFOXITIN SODIUM CEFOXITIN, CEFOXITIN CEFOXITIN, CEFOXITIN SODIUM CEFPODOXIME PROXETIL, CEFPODOXIME PROXETIL CEFPROZIL, CEFPROZIL CEFTAZIDIME IN DEXTROSE CONTAINER, CEFTAZIDIME CEFTAZIDIME, CEFTAZIDIME CEFTIN, CEFUROXIME AXETIL CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER, CEFTRIAXONE SODIUM CEFTRIAXONE IN PLASTIC CONTAINER, CEFTRIAXONE SODIUM CEFTRIAXONE, CEFTRIAXONE SODIUM CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER, CEFUROXIME SODIUM

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

**

PRODUCT NAME INDEX

C **

A - 10

CEFUROXIME AXETIL, CEFUROXIME AXETIL CEFUROXIME SODIUM IN PLASTIC CONTAINER, CEFUROXIME SODIUM CEFUROXIME SODIUM, CEFUROXIME SODIUM CELEBREX, CELECOXIB CELESTONE SOLUSPAN, BETAMETHASONE ACETATE CELESTONE, BETAMETHASONE CELEXA, CITALOPRAM HYDROBROMIDE CELLCEPT, MYCOPHENOLATE MOFETIL CELLCEPT, MYCOPHENOLATE MOFETIL HYDROCHLORIDE CELONTIN, METHSUXIMIDE CENESTIN, ESTROGENS, CONJUGATED SYNTHETIC A CENTANY, MUPIROCIN CEPHALEXIN, CEPHALEXIN CEREDASE, ALGLUCERASE CERETEC, TECHNETIUM TC-99M EXAMETAZIME KIT CEREZYME, IMIGLUCERASE CERUBIDINE, DAUNORUBICIN HYDROCHLORIDE CERVIDIL, DINOPROSTONE CESAMET, NABILONE CETAMIDE, SULFACETAMIDE SODIUM CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE CETRAXAL, CIPROFLOXACIN HYDROCHLORIDE CETROTIDE, CETRORELIX CEVIMELINE, CEVIMELINE HYDROCHLORIDE CHANTIX, VARENICLINE TARTRATE CHEMET, SUCCIMER CHENODIOL, CHENODIOL CHG SCRUB, CHLORHEXIDINE GLUCONATE (OTC) CHILDREN'S ADVIL ALLERGY SINUS, CHLORPHENIRAMINE MALEATE (OTC) CHILDREN'S ADVIL COLD, IBUPROFEN (OTC) CHILDREN'S ADVIL, IBUPROFEN (OTC) CHILDREN'S ADVIL-FLAVORED, IBUPROFEN (OTC) CHILDREN'S ALLEGRA ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC) CHILDREN'S ALLEGRA HIVES, FEXOFENADINE HYDROCHLORIDE (OTC) CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) CHILDREN'S CLARITIN, LORATADINE (OTC) CHILDREN'S ELIXSURE, IBUPROFEN (OTC) CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC) CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC) CHILDREN'S IBUPROFEN, IBUPROFEN (OTC) CHILDREN'S MOTRIN COLD, IBUPROFEN (OTC) CHILDREN'S MOTRIN, IBUPROFEN (OTC) CHILDREN'S ZYRTEC ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CHILDREN'S ZYRTEC HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) CHIRHOSTIM, SECRETIN SYNTHETIC HUMAN CHLORAMPHENICOL SODIUM SUCCINATE, CHLORAMPHENICOL SODIUM SUCCINATE CHLORAPREP ONE-STEP FREPP, CHLORHEXIDINE GLUCONATE (OTC) CHLORAPREP ONE-STEP SEPP, CHLORHEXIDINE GLUCONATE (OTC) CHLORAPREP ONE-STEP, CHLORHEXIDINE GLUCONATE (OTC) CHLORAPREP SINGLE SWABSTICK, CHLORHEXIDINE GLUCONATE (OTC) CHLORAPREP TRIPLE SWABSTICK, CHLORHEXIDINE GLUCONATE (OTC) CHLORAPREP WITH TINT, CHLORHEXIDINE GLUCONATE (OTC) CHLORASCRUB MAXI SWABSTICK, CHLORHEXIDINE GLUCONATE (OTC) CHLORASCRUB SWAB, CHLORHEXIDINE GLUCONATE (OTC) CHLORASCRUB SWABSTICK, CHLORHEXIDINE GLUCONATE (OTC) CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE CHLORDIAZEPOXIDE HYDROCHLORIDE, CHLORDIAZEPOXIDE HYDROCHLORIDE CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE

(OTC)

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

**

PRODUCT NAME INDEX

C **

A - 11

CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE (OTC) CHLOROPROCAINE HYDROCHLORIDE, CHLOROPROCAINE HYDROCHLORIDE CHLOROQUINE PHOSPHATE, CHLOROQUINE PHOSPHATE CHLOROTHIAZIDE SODIUM, CHLOROTHIAZIDE SODIUM CHLOROTHIAZIDE, CHLOROTHIAZIDE CHLORPHENIRAMINE MALEATE, CHLORPHENIRAMINE MALEATE (OTC) CHLORPROMAZINE HYDROCHLORIDE, CHLORPROMAZINE HYDROCHLORIDE CHLORPROPAMIDE, CHLORPROPAMIDE CHLORTHALIDONE, CHLORTHALIDONE CHLOR-TRIMETON, CHLORPHENIRAMINE MALEATE (OTC) CHLORZOXAZONE, CHLORZOXAZONE CHOLAC, LACTULOSE CHOLEDYL SA, OXTRIPHYLLINE CHOLESTYRAMINE LIGHT, CHOLESTYRAMINE CHOLESTYRAMINE, CHOLESTYRAMINE CHOLETEC, TECHNETIUM TC-99M MEBROFENIN KIT CHOLOGRAFIN MEGLUMINE, IODIPAMIDE MEGLUMINE CHORIONIC GONADOTROPIN, GONADOTROPIN, CHORIONIC CHROMIC CHLORIDE IN PLASTIC CONTAINER, CHROMIC CHLORIDE CHROMITOPE SODIUM, SODIUM CHROMATE CR-51 CIALIS, TADALAFIL CICLOPIROX, CICLOPIROX CIDA-STAT, CHLORHEXIDINE GLUCONATE (OTC) CILOSTAZOL, CILOSTAZOL CILOXAN, CIPROFLOXACIN HYDROCHLORIDE CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE CIMETIDINE, CIMETIDINE CIMETIDINE, CIMETIDINE (OTC) CIPRO HC, CIPROFLOXACIN HYDROCHLORIDE CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN CIPRO XR, CIPROFLOXACIN CIPRO, CIPROFLOXACIN CIPRO, CIPROFLOXACIN HYDROCHLORIDE CIPRODEX, CIPROFLOXACIN CIPROFLOXACIN EXTENDED RELEASE, CIPROFLOXACIN CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN CIPROFLOXACIN, CIPROFLOXACIN CIS-MDP, TECHNETIUM TC-99M MEDRONATE KIT CISPLATIN, CISPLATIN CIS-PYRO, TECHNETIUM TC-99M PYROPHOSPHATE KIT CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE CITANEST FORTE DENTAL, EPINEPHRINE BITARTRATE CITANEST PLAIN DENTAL, PRILOCAINE HYDROCHLORIDE CLADRIBINE, CLADRIBINE CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER, CEFOTAXIME SODIUM CLAFORAN, CEFOTAXIME SODIUM CLARAVIS, ISOTRETINOIN CLARINEX D 24 HOUR, DESLORATADINE CLARINEX, DESLORATADINE CLARINEX-D 12 HOUR, DESLORATADINE CLARITHROMYCIN, CLARITHROMYCIN CLARITIN HIVES RELIEF REDITAB, LORATADINE (OTC) CLARITIN HIVES RELIEF, LORATADINE (OTC) CLARITIN REDITABS, LORATADINE (OTC) CLARITIN, LORATADINE (OTC) CLARITIN-D 24 HOUR, LORATADINE (OTC) CLARITIN-D, LORATADINE (OTC) CLEMASTINE FUMARATE, CLEMASTINE FUMARATE CLEMASTINE FUMARATE, CLEMASTINE FUMARATE (OTC) CLENZ-LYTE, POLYETHYLENE GLYCOL 3350 CLEOCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER, CLINDAMYCIN PHOSPHATE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

**

PRODUCT NAME INDEX

C **

A - 12

CLEOCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE CLEOCIN T, CLINDAMYCIN PHOSPHATE CLEOCIN, CLINDAMYCIN PALMITATE HYDROCHLORIDE CLEOCIN, CLINDAMYCIN PHOSPHATE CLEVIPREX, CLEVIDIPINE BUTYRATE CLIMARA PRO, ESTRADIOL CLIMARA, ESTRADIOL CLINDA-DERM, CLINDAMYCIN PHOSPHATE CLINDAGEL, CLINDAMYCIN PHOSPHATE CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN PALMITATE HYDROCHLORIDE, CLINDAMYCIN PALMITATE HYDROCHLORIDE CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE, BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%, CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE CLINDESSE, CLINDAMYCIN PHOSPHATE CLINDETS, CLINDAMYCIN PHOSPHATE CLINIMIX 2.75/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX 2.75/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX 2.75/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX 4.25/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX 4.25/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX 4.25/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX 4.25/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX 5/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX 5/15 SULFITE FREE IN DEXTROSE 15% IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX 5/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX 5/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX 5/35 SULFITE FREE IN DEXTROSE 35% IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX E 2.75/10 SULFITE-FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX E 2.75/25 SULFITE-FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX E 2.75/5 SULFITE-FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX E 4.25/10 SULFITE-FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX E 4.25/20 SULFITE-FREE W/ ELECT IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX E 4.25/25 SULFITE-FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX E 4.25/5 SULFITE-FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX E 5/10 SULFITE-FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX E 5/15 SULFITE-FREE W/ ELECT IN DEXTROSE 15% W/ CALCIUM IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX E 5/20 SULFITE-FREE W/ ELECT IN 20% DEXTROSE W/ CALCIUM IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX E 5/25 SULFITE-FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX E 5/35 SULFITE-FREE W/ ELECT IN DEXTROSE 35% W/ CALCIUM IN PLASTIC CONTAINER, AMINO ACIDS CLINISOL 15% SULFITE FREE IN PLASTIC CONTAINER, AMINO ACIDS CLINORIL, SULINDAC CLOBETASOL PROPIONATE (EMOLLIENT), CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE CLOBEX, CLOBETASOL PROPIONATE CLODERM, CLOCORTOLONE PIVALATE CLOLAR, CLOFARABINE CLOMID, CLOMIPHENE CITRATE CLOMIPHENE CITRATE, CLOMIPHENE CITRATE CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE CLONAZEPAM, CLONAZEPAM CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE CLONIDINE, CLONIDINE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

**

PRODUCT NAME INDEX

C **

A - 13

CLORAZEPATE DIPOTASSIUM, CLORAZEPATE DIPOTASSIUM CLORPRES, CHLORTHALIDONE CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE CLOTRIMAZOLE, CLOTRIMAZOLE CLOTRIMAZOLE, CLOTRIMAZOLE (OTC) CLOZAPINE, CLOZAPINE CLOZARIL, CLOZAPINE COARTEM, ARTEMETHER CODEINE SULFATE, CODEINE SULFATE COGENTIN, BENZTROPINE MESYLATE CO-GESIC, ACETAMINOPHEN COLAZAL, BALSALAZIDE DISODIUM COLCRYS, COLCHICINE COLESTID, COLESTIPOL HYDROCHLORIDE COLESTIPOL HYDROCHLORIDE, COLESTIPOL HYDROCHLORIDE COLGATE TOTAL, SODIUM FLUORIDE (OTC) COLISTIMETHATE SODIUM, COLISTIMETHATE SODIUM COLOCORT, HYDROCORTISONE COL-PROBENECID, COLCHICINE COLY-MYCIN M, COLISTIMETHATE SODIUM COLY-MYCIN S, COLISTIN SULFATE COLYTE WITH FLAVOR PACKS, POLYETHYLENE GLYCOL 3350 COLYTE, POLYETHYLENE GLYCOL 3350 COLYTE-FLAVORED, POLYETHYLENE GLYCOL 3350 COMBIGAN, BRIMONIDINE TARTRATE COMBIPATCH, ESTRADIOL COMBIVENT RESPIMAT, ALBUTEROL SULFATE COMBIVENT, ALBUTEROL SULFATE COMBIVIR, LAMIVUDINE COMMIT, NICOTINE POLACRILEX (OTC) COMPLERA, EMTRICITABINE COMPRO, PROCHLORPERAZINE COMTAN, ENTACAPONE CONCERTA, METHYLPHENIDATE HYDROCHLORIDE CONDYLOX, PODOFILOX CONRAY 30, IOTHALAMATE MEGLUMINE CONRAY 43, IOTHALAMATE MEGLUMINE CONRAY, IOTHALAMATE MEGLUMINE CONSTILAC, LACTULOSE CONSTULOSE, LACTULOSE CONZIP, TRAMADOL HYDROCHLORIDE COPAXONE, GLATIRAMER ACETATE COPEGUS, RIBAVIRIN CORDARONE, AMIODARONE HYDROCHLORIDE CORDRAN SP, FLURANDRENOLIDE CORDRAN, FLURANDRENOLIDE COREG CR, CARVEDILOL PHOSPHATE COREG, CARVEDILOL CORGARD, NADOLOL CORLOPAM, FENOLDOPAM MESYLATE CORMAX, CLOBETASOL PROPIONATE CORTEF, HYDROCORTISONE CORTENEMA, HYDROCORTISONE CORTIFOAM, HYDROCORTISONE ACETATE CORTISONE ACETATE, CORTISONE ACETATE CORTISPORIN, BACITRACIN ZINC CORTISPORIN, HYDROCORTISONE CORTISPORIN, HYDROCORTISONE ACETATE CORTROSYN, COSYNTROPIN CORVERT, IBUTILIDE FUMARATE CORZIDE, BENDROFLUMETHIAZIDE COSMEGEN, DACTINOMYCIN COSOPT, DORZOLAMIDE HYDROCHLORIDE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

**

PRODUCT NAME INDEX

C **

A - 14

COSYNTROPIN, COSYNTROPIN COUMADIN, WARFARIN SODIUM COVERA-HS, VERAPAMIL HYDROCHLORIDE COZAAR, LOSARTAN POTASSIUM CREON, LIPASE CRESTOR, ROSUVASTATIN CALCIUM CRINONE, PROGESTERONE CRIXIVAN, INDINAVIR SULFATE CROLOM, CROMOLYN SODIUM CROMOLYN SODIUM, CROMOLYN SODIUM CROMOLYN SODIUM, CROMOLYN SODIUM (OTC) CROTAN, CROTAMITON CRYSELLE, ETHINYL ESTRADIOL CUBICIN, DAPTOMYCIN CUPRIC CHLORIDE IN PLASTIC CONTAINER, CUPRIC CHLORIDE CUPRIMINE, PENICILLAMINE CUROSURF, PORACTANT ALFA CUTIVATE, FLUTICASONE PROPIONATE CUVPOSA, GLYCOPYRROLATE CYANOCOBALAMIN, CYANOCOBALAMIN CYANOKIT, HYDROXOCOBALAMIN CYCLAFEM 1/35, ETHINYL ESTRADIOL CYCLAFEM 7/7/7, ETHINYL ESTRADIOL CYCLESSA, DESOGESTREL CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE CYCLOGYL, CYCLOPENTOLATE HYDROCHLORIDE CYCLOMYDRIL, CYCLOPENTOLATE HYDROCHLORIDE CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE CYCLOSET, BROMOCRIPTINE MESYLATE CYCLOSPORINE, CYCLOSPORINE CYKLOKAPRON, TRANEXAMIC ACID CYMBALTA, DULOXETINE HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE CYSTADANE, BETAINE HYDROCHLORIDE CYSTAGON, CYSTEAMINE BITARTRATE CYSTO-CONRAY II, IOTHALAMATE MEGLUMINE CYSTOGRAFIN DILUTE, DIATRIZOATE MEGLUMINE CYSTOGRAFIN, DIATRIZOATE MEGLUMINE CYSVIEW KIT, HEXAMINOLEVULINATE HYDROCHLORIDE CYTARABINE, CYTARABINE CYTOMEL, LIOTHYRONINE SODIUM CYTOSAR-U, CYTARABINE CYTOTEC, MISOPROSTOL CYTOVENE, GANCICLOVIR SODIUM CYTOXAN, CYCLOPHOSPHAMIDE

**

**

D.H.E. 45, DIHYDROERGOTAMINE MESYLATE DACARBAZINE, DACARBAZINE DACOGEN, DECITABINE DACTINOMYCIN, DACTINOMYCIN DALIRESP, ROFLUMILAST DANAZOL, DANAZOL DANTRIUM, DANTROLENE SODIUM DANTROLENE SODIUM, DANTROLENE SODIUM DAPSONE, DAPSONE DARAPRIM, PYRIMETHAMINE DASETTA 1/35, ETHINYL ESTRADIOL DASETTA 7/7/7, ETHINYL ESTRADIOL DATSCAN, IOFLUPANE I-123 DAUNORUBICIN HYDROCHLORIDE, DAUNORUBICIN HYDROCHLORIDE DAUNOXOME, DAUNORUBICIN CITRATE DAYPRO, OXAPROZIN

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

**

PRODUCT NAME INDEX

D **

A - 15

DAYTRANA, METHYLPHENIDATE DDAVP (NEEDS NO REFRIGERATION), DESMOPRESSIN ACETATE DDAVP, DESMOPRESSIN ACETATE DECLOMYCIN, DEMECLOCYCLINE HYDROCHLORIDE DEFEROXAMINE MESYLATE, DEFEROXAMINE MESYLATE DEFINITY, PERFLUTREN DELATESTRYL, TESTOSTERONE ENANTHATE DELESTROGEN, ESTRADIOL VALERATE DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE DELFLEX W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE DELFLEX-LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DELFLEX-LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DELFLEX-LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DELFLEX-LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DELSYM, DEXTROMETHORPHAN POLISTIREX (OTC) DEMADEX, TORSEMIDE DEMECLOCYCLINE HYDROCHLORIDE, DEMECLOCYCLINE HYDROCHLORIDE DEMEROL, MEPERIDINE HYDROCHLORIDE DEMSER, METYROSINE DENAVIR, PENCICLOVIR SODIUM DENDRID, IDOXURIDINE DEPACON, VALPROATE SODIUM DEPAKENE, VALPROIC ACID DEPAKOTE ER, DIVALPROEX SODIUM DEPAKOTE, DIVALPROEX SODIUM DEPEN, PENICILLAMINE DEPOCYT, CYTARABINE DEPODUR, MORPHINE SULFATE DEPO-ESTRADIOL, ESTRADIOL CYPIONATE DEPO-MEDROL, METHYLPREDNISOLONE ACETATE DEPO-PROVERA, MEDROXYPROGESTERONE ACETATE DEPO-SUBQ PROVERA 104, MEDROXYPROGESTERONE ACETATE DEPO-TESTOSTERONE, TESTOSTERONE CYPIONATE DERMABET, BETAMETHASONE VALERATE DERMA-SMOOTHE/FS, FLUOCINOLONE ACETONIDE DERMATOP E EMOLLIENT, PREDNICARBATE DERMATOP, PREDNICARBATE DERMOTIC, FLUOCINOLONE ACETONIDE DESFERAL, DEFEROXAMINE MESYLATE DESIPRAMINE HYDROCHLORIDE, DESIPRAMINE HYDROCHLORIDE DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOUR, DESLORATADINE DESLORATADINE, DESLORATADINE DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION), DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE DESOGEN, DESOGESTREL DESOGESTREL AND ETHINYL ESTRADIOL, DESOGESTREL DESONATE, DESONIDE DESONIDE, DESONIDE DESOWEN, DESONIDE DESOXIMETASONE, DESOXIMETASONE DESOXYN, METHAMPHETAMINE HYDROCHLORIDE DETROL LA, TOLTERODINE TARTRATE DETROL, TOLTERODINE TARTRATE DEXAMETHASONE INTENSOL, DEXAMETHASONE DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

**

PRODUCT NAME INDEX

D **

A - 16

DEXAMETHASONE, DEXAMETHASONE DEXASPORIN, DEXAMETHASONE DEXCHLORPHENIRAMINE MALEATE, DEXCHLORPHENIRAMINE MALEATE DEXEDRINE, DEXTROAMPHETAMINE SULFATE DEXFERRUM, IRON DEXTRAN DEXILANT, DEXLANSOPRAZOLE DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE DEXRAZOXANE HYDROCHLORIDE, DEXRAZOXANE HYDROCHLORIDE DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE ASPARTATE DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 10% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE DEXTROSE 20% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 25%, DEXTROSE DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 30% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 40% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% AND ELECTROLYTE NO 75 IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% AND ELECTROLYTE NO.48 IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% AND RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% IN ACETATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% IN RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE DEXTROSE 5% IN SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% IN SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ, DEXTROSE DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K), DEXTROSE DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ (K), DEXTROSE DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ, DEXTROSE DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 30MEQ, DEXTROSE DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 40MEQ, DEXTROSE DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (K), DEXTROSE DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ, DEXTROSE DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER, DEXTROSE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

**

PRODUCT NAME INDEX

D **

A - 17

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 50% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 60% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 70% IN PLASTIC CONTAINER, DEXTROSE DIABETA, GLYBURIDE DIABINESE, CHLORPROPAMIDE DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIAMOX, ACETAZOLAMIDE DIAMOX, ACETAZOLAMIDE SODIUM DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIANEAL LOW CALCIUM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIANEAL LOW CALCIUM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIANEAL PD-1 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIANEAL PD-1 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIANEAL PD-1 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIANEAL PD-2 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIASTAT ACUDIAL, DIAZEPAM DIASTAT, DIAZEPAM DIAZEPAM INTENSOL, DIAZEPAM DIAZEPAM, DIAZEPAM DIBENZYLINE, PHENOXYBENZAMINE HYDROCHLORIDE DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM DICLOFENAC SODIUM, DICLOFENAC SODIUM DICLOXACILLIN SODIUM, DICLOXACILLIN SODIUM DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE-FREE), DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE DIDANOSINE, DIDANOSINE DIDREX, BENZPHETAMINE HYDROCHLORIDE DIDRONEL, ETIDRONATE DISODIUM DIETHYLPROPION HYDROCHLORIDE, DIETHYLPROPION HYDROCHLORIDE DIFFERIN, ADAPALENE DIFICID, FIDAXOMICIN DIFLORASONE DIACETATE, DIFLORASONE DIACETATE DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER, FLUCONAZOLE DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE DIFLUCAN IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE DIFLUCAN, FLUCONAZOLE DIFLUNISAL, DIFLUNISAL DIGOXIN, DIGOXIN DIHYDROERGOTAMINE MESYLATE, DIHYDROERGOTAMINE MESYLATE DILACOR XR, DILTIAZEM HYDROCHLORIDE DILANTIN, PHENYTOIN DILANTIN, PHENYTOIN SODIUM DILANTIN-125, PHENYTOIN DILATRATE-SR, ISOSORBIDE DINITRATE DILAUDID, HYDROMORPHONE HYDROCHLORIDE DILAUDID-HP, HYDROMORPHONE HYDROCHLORIDE DILT-CD, DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

**

PRODUCT NAME INDEX

D **

A - 18

DILTZAC, DILTIAZEM HYDROCHLORIDE DIMENHYDRINATE, DIMENHYDRINATE DIMETHYL SULFOXIDE, DIMETHYL SULFOXIDE DIOVAN HCT, HYDROCHLOROTHIAZIDE DIOVAN, VALSARTAN DIPENTUM, OLSALAZINE SODIUM DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE, DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE DIPIVEFRIN HYDROCHLORIDE, DIPIVEFRIN HYDROCHLORIDE DIPRIVAN, PROPOFOL DIPROLENE AF, BETAMETHASONE DIPROPIONATE DIPROLENE, BETAMETHASONE DIPROPIONATE DIPYRIDAMOLE, DIPYRIDAMOLE DISOPHROL, DEXBROMPHENIRAMINE MALEATE (OTC) DISOPYRAMIDE PHOSPHATE, DISOPYRAMIDE PHOSPHATE DISPERMOX, AMOXICILLIN DISULFIRAM, DISULFIRAM DITROPAN XL, OXYBUTYNIN CHLORIDE DITROPAN, OXYBUTYNIN CHLORIDE DIURIL, CHLOROTHIAZIDE DIURIL, CHLOROTHIAZIDE SODIUM DIVALPROEX SODIUM, DIVALPROEX SODIUM DIVIGEL, ESTRADIOL DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOBUTAMINE HYDROCHLORIDE DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%, DOBUTAMINE HYDROCHLORIDE DOBUTAMINE HYDROCHLORIDE, DOBUTAMINE HYDROCHLORIDE DOCEFREZ, DOCETAXEL DOCETAXEL, DOCETAXEL DOLOPHINE HYDROCHLORIDE, METHADONE HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER, DOPAMINE HYDROCHLORIDE DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%, DOPAMINE HYDROCHLORIDE DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOPAMINE HYDROCHLORIDE DOPAMINE HYDROCHLORIDE, DOPAMINE HYDROCHLORIDE DOPRAM, DOXAPRAM HYDROCHLORIDE DORAL, QUAZEPAM DORIBAX, DORIPENEM DORYX, DOXYCYCLINE HYCLATE DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE DOVONEX, CALCIPOTRIENE DOXAPRAM HYDROCHLORIDE, DOXAPRAM HYDROCHLORIDE DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE DOXERCALCIFEROL, DOXERCALCIFEROL DOXIL, DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE DOXY 100, DOXYCYCLINE HYCLATE DOXY 200, DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE DOXYCYCLINE, DOXYCYCLINE DOXYCYCLINE, DOXYCYCLINE HYCLATE DOXYLAMINE SUCCINATE, DOXYLAMINE SUCCINATE (OTC) DRAXIMAGE MDP-25, TECHNETIUM TC-99M MEDRONATE DRISDOL, ERGOCALCIFEROL DRIXORAL PLUS, ACETAMINOPHEN (OTC) DRIXORAL, DEXBROMPHENIRAMINE MALEATE (OTC) DRONABINOL, DRONABINOL DROPERIDOL, DROPERIDOL DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE DROXIA, HYDROXYUREA DTIC-DOME, DACARBAZINE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A
DTPA, TECHNETIUM TC-99M PENTETATE KIT DUAC, BENZOYL PEROXIDE DUETACT, GLIMEPIRIDE DUEXIS, FAMOTIDINE DULERA, FORMOTEROL FUMARATE DUODOTE, ATROPINE DUONEB, ALBUTEROL SULFATE DURACLON, CLONIDINE HYDROCHLORIDE DURAGESIC-100, FENTANYL DURAGESIC-12, FENTANYL DURAGESIC-25, FENTANYL DURAGESIC-50, FENTANYL DURAGESIC-75, FENTANYL DURAMORPH PF, MORPHINE SULFATE DURAPREP, IODINE POVACRYLEX (OTC) DUREZOL, DIFLUPREDNATE DUTASTERIDE, DUTASTERIDE DUVOID, BETHANECHOL CHLORIDE DYAZIDE, HYDROCHLOROTHIAZIDE DYNACIN, MINOCYCLINE HYDROCHLORIDE DYNACIRC CR, ISRADIPINE DYNA-HEX, CHLORHEXIDINE GLUCONATE (OTC) DYRENIUM, TRIAMTERENE

**

PRODUCT NAME INDEX

D **

A - 19

**
E.E.S. 200, ERYTHROMYCIN ETHYLSUCCINATE E.E.S. 400, ERYTHROMYCIN ETHYLSUCCINATE E.E.S., ERYTHROMYCIN ETHYLSUCCINATE EC-NAPROSYN, NAPROXEN ECONAZOLE NITRATE, ECONAZOLE NITRATE EDARBI, AZILSARTAN KAMEDOXOMIL EDARBYCLOR, AZILSARTAN KAMEDOXOMIL EDECRIN, ETHACRYNATE SODIUM EDECRIN, ETHACRYNIC ACID EDEX, ALPROSTADIL EDLUAR, ZOLPIDEM TARTRATE EDURANT, RILPIVIRINE HYDROCHLORIDE EFFEXOR XR, VENLAFAXINE HYDROCHLORIDE EFFIENT, PRASUGREL HYDROCHLORIDE EFUDEX, FLUOROURACIL E-GLADES, ERYTHROMYCIN EGRIFTA, TESAMORELIN ACETATE ELDEPRYL, SELEGILINE HYDROCHLORIDE ELESTAT, EPINASTINE HYDROCHLORIDE ELESTRIN, ESTRADIOL ELIDEL, PIMECROLIMUS ELIGARD, LEUPROLIDE ACETATE ELIMITE, PERMETHRIN ELIPHOS, CALCIUM ACETATE ELIXOPHYLLIN, THEOPHYLLINE ELLA, ULIPRISTAL ACETATE ELLENCE, EPIRUBICIN HYDROCHLORIDE ELLIOTTS B SOLUTION, CALCIUM CHLORIDE ELMIRON, PENTOSAN POLYSULFATE SODIUM ELOCON, MOMETASONE FUROATE ELOXATIN, OXALIPLATIN EMADINE, EMEDASTINE DIFUMARATE EMBEDA, MORPHINE SULFATE EMBELINE E, CLOBETASOL PROPIONATE EMBELINE, CLOBETASOL PROPIONATE EMCYT, ESTRAMUSTINE PHOSPHATE SODIUM EMEND, APREPITANT EMEND, FOSAPREPITANT DIMEGLUMINE

**

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

**

PRODUCT NAME INDEX

E **

A - 20

EMLA, LIDOCAINE EMOQUETTE, DESOGESTREL EMSAM, SELEGILINE EMTRIVA, EMTRICITABINE ENABLEX, DARIFENACIN HYDROBROMIDE ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE ENALAPRIL MALEATE, ENALAPRIL MALEATE ENALAPRILAT, ENALAPRILAT ENDOMETRIN, PROGESTERONE ENDOSOL EXTRA, CALCIUM CHLORIDE ENDURON, METHYCLOTHIAZIDE ENFLURANE, ENFLURANE ENJUVIA, ESTROGENS, CONJUGATED SYNTHETIC B ENLON, EDROPHONIUM CHLORIDE ENLON-PLUS, ATROPINE SULFATE ENOXAPARIN SODIUM (PRESERVATIVE FREE), ENOXAPARIN SODIUM ENOXAPARIN SODIUM, ENOXAPARIN SODIUM ENPRESSE-28, ETHINYL ESTRADIOL ENTEREG, ALVIMOPAN ENTOCORT EC, BUDESONIDE ENULOSE, LACTULOSE EOVIST, GADOXETATE DISODIUM EPIDUO, ADAPALENE EPIFOAM, HYDROCORTISONE ACETATE EPINASTINE HYDROCHLORIDE, EPINASTINE HYDROCHLORIDE EPINEPHRINE, EPINEPHRINE (OTC) EPIPEN JR., EPINEPHRINE EPIPEN, EPINEPHRINE EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE EPITOL, CARBAMAZEPINE EPIVIR, LAMIVUDINE EPIVIR-HBV, LAMIVUDINE EPLERENONE, EPLERENONE EPOPROSTENOL SODIUM, EPOPROSTENOL SODIUM EPROSARTAN MESYLATE, EPROSARTAN MESYLATE EPZICOM, ABACAVIR SULFATE EQUETRO, CARBAMAZEPINE ERAXIS, ANIDULAFUNGIN ERGOCALCIFEROL, ERGOCALCIFEROL ERGOLOID MESYLATES, ERGOLOID MESYLATES ERGOMAR, ERGOTAMINE TARTRATE ERGOTAMINE TARTRATE AND CAFFEINE, CAFFEINE ERRIN, NORETHINDRONE ERTACZO, SERTACONAZOLE NITRATE ERYC, ERYTHROMYCIN ERYGEL, ERYTHROMYCIN ERYPED, ERYTHROMYCIN ETHYLSUCCINATE ERY-TAB, ERYTHROMYCIN ERYTHRA-DERM, ERYTHROMYCIN ERYTHROCIN STEARATE, ERYTHROMYCIN STEARATE ERYTHROCIN, ERYTHROMYCIN LACTOBIONATE ERYTHROMYCIN AND BENZOYL PEROXIDE, BENZOYL PEROXIDE ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL, ERYTHROMYCIN ETHYLSUCCINATE ERYTHROMYCIN ETHYLSUCCINATE, ERYTHROMYCIN ETHYLSUCCINATE ERYTHROMYCIN, ERYTHROMYCIN ERYTHRO-STATIN, ERYTHROMYCIN ESGIC-PLUS, ACETAMINOPHEN ESMOLOL HYDROCHLORIDE, ESMOLOL HYDROCHLORIDE ESTAZOLAM, ESTAZOLAM ESTRACE, ESTRADIOL ESTRADERM, ESTRADIOL ESTRADIOL AND NORETHINDRONE ACETATE, ESTRADIOL ESTRADIOL AND NORGESTIMATE, ESTRADIOL

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

**

PRODUCT NAME INDEX

E **

A - 21

ESTRADIOL CYPIONATE, ESTRADIOL CYPIONATE ESTRADIOL VALERATE, ESTRADIOL VALERATE ESTRADIOL, ESTRADIOL ESTRASORB, ESTRADIOL HEMIHYDRATE ESTRING, ESTRADIOL ESTROGEL, ESTRADIOL ESTRONE, ESTRONE ESTROPIPATE, ESTROPIPATE ESTROSTEP FE, ETHINYL ESTRADIOL ETHAMBUTOL HYDROCHLORIDE, ETHAMBUTOL HYDROCHLORIDE ETHAMOLIN, ETHANOLAMINE OLEATE ETHOSUXIMIDE, ETHOSUXIMIDE ETHRANE, ENFLURANE ETHYOL, AMIFOSTINE ETIDRONATE DISODIUM, ETIDRONATE DISODIUM ETODOLAC, ETODOLAC ETOMIDATE, ETOMIDATE ETOPOPHOS PRESERVATIVE FREE, ETOPOSIDE PHOSPHATE ETOPOSIDE, ETOPOSIDE EURAX, CROTAMITON EVAMIST, ESTRADIOL EVISTA, RALOXIFENE HYDROCHLORIDE EVOCLIN, CLINDAMYCIN PHOSPHATE EVOXAC, CEVIMELINE HYDROCHLORIDE EXALGO, HYDROMORPHONE HYDROCHLORIDE EXCEDRIN (MIGRAINE), ACETAMINOPHEN (OTC) EXELDERM, SULCONAZOLE NITRATE EXELON, RIVASTIGMINE EXELON, RIVASTIGMINE TARTRATE EXEMESTANE, EXEMESTANE EXFORGE HCT, AMLODIPINE BESYLATE EXFORGE, AMLODIPINE BESYLATE EXIDINE, CHLORHEXIDINE GLUCONATE (OTC) EXJADE, DEFERASIROX EXPAREL, BUPIVACAINE EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM EXTINA, KETOCONAZOLE EXTRANEAL, ICODEXTRIN E-Z SCRUB 201, POVIDONE-IODINE (OTC) E-Z SCRUB 241, POVIDONE-IODINE (OTC)

**

**

FACTIVE, GEMIFLOXACIN MESYLATE FAMCICLOVIR, FAMCICLOVIR FAMOTIDINE PRESERVATIVE FREE (PHARMACY BULK), FAMOTIDINE FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER, FAMOTIDINE FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE FAMOTIDINE, FAMOTIDINE FAMOTIDINE, FAMOTIDINE (OTC) FAMVIR, FAMCICLOVIR FANAPT, ILOPERIDONE FARESTON, TOREMIFENE CITRATE FASLODEX, FULVESTRANT FAZACLO ODT, CLOZAPINE FELBAMATE, FELBAMATE FELBATOL, FELBAMATE FELDENE, PIROXICAM FELODIPINE, FELODIPINE FEMARA, LETROZOLE FEMCON FE, ETHINYL ESTRADIOL FEMHRT, ETHINYL ESTRADIOL FEMRING, ESTRADIOL ACETATE FEMSTAT 3, BUTOCONAZOLE NITRATE (OTC)

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

**

PRODUCT NAME INDEX

F **

A - 22

FEMTRACE, ESTRADIOL ACETATE FENOFIBRATE (MICRONIZED), FENOFIBRATE FENOFIBRATE, FENOFIBRATE FENOGLIDE, FENOFIBRATE FENOLDOPAM MESYLATE, FENOLDOPAM MESYLATE FENOPROFEN CALCIUM, FENOPROFEN CALCIUM FENTANYL CITRATE PRESERVATIVE FREE, FENTANYL CITRATE FENTANYL CITRATE, FENTANYL CITRATE FENTANYL-100, FENTANYL FENTANYL-12, FENTANYL FENTANYL-25, FENTANYL FENTANYL-50, FENTANYL FENTANYL-75, FENTANYL FENTORA, FENTANYL CITRATE FERAHEME, FERUMOXYTOL FERIDEX I.V., FERUMOXIDES FERRIPROX, DEFERIPRONE FERRLECIT, SODIUM FERRIC GLUCONATE COMPLEX FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC) FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC) FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE FIBRICOR, FENOFIBRIC ACID FINACEA, AZELAIC ACID FINASTERIDE, FINASTERIDE FIORICET W/ CODEINE, ACETAMINOPHEN FIORICET, ACETAMINOPHEN FIORINAL W/CODEINE, ASPIRIN FIORINAL, ASPIRIN FIRAZYR, ICATIBANT ACETATE FIRMAGON, DEGARELIX ACETATE FLAGYL ER, METRONIDAZOLE FLAGYL I.V. RTU IN PLASTIC CONTAINER, METRONIDAZOLE FLAGYL, METRONIDAZOLE FLAREX, FLUOROMETHOLONE ACETATE FLAVORED COLESTID, COLESTIPOL HYDROCHLORIDE FLAVOXATE HYDROCHLORIDE, FLAVOXATE HYDROCHLORIDE FLECAINIDE ACETATE, FLECAINIDE ACETATE FLECTOR, DICLOFENAC EPOLAMINE FLEXERIL, CYCLOBENZAPRINE HYDROCHLORIDE FLOLAN, EPOPROSTENOL SODIUM FLOMAX, TAMSULOSIN HYDROCHLORIDE FLONASE, FLUTICASONE PROPIONATE FLO-PRED, PREDNISOLONE ACETATE FLOVENT DISKUS 100, FLUTICASONE PROPIONATE FLOVENT DISKUS 250, FLUTICASONE PROPIONATE FLOVENT DISKUS 50, FLUTICASONE PROPIONATE FLOVENT HFA, FLUTICASONE PROPIONATE FLOXIN OTIC, OFLOXACIN FLOXURIDINE, FLOXURIDINE FLUCANAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER, FLUCONAZOLE FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE FLUCONAZOLE, FLUCONAZOLE FLUCYTOSINE, FLUCYTOSINE FLUDARA, FLUDARABINE PHOSPHATE FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE FLUDEOXYGLUCOSE F 18, FLUDEOXYGLUCOSE F-18 FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18 FLUDROCORTISONE ACETATE, FLUDROCORTISONE ACETATE FLUMADINE, RIMANTADINE HYDROCHLORIDE

(OTC)

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

**

PRODUCT NAME INDEX

F **

A - 23

FLUMAZENIL, FLUMAZENIL FLUNISOLIDE, FLUNISOLIDE FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE FLUOCINONIDE EMULSIFIED BASE, FLUOCINONIDE FLUOCINONIDE, FLUOCINONIDE FLUORESCITE, FLUORESCEIN SODIUM FLUOROPLEX, FLUOROURACIL FLUOROURACIL, FLUOROURACIL FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE FLUOXYMESTERONE, FLUOXYMESTERONE FLUPHENAZINE DECANOATE, FLUPHENAZINE DECANOATE FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE FLURAZEPAM HYDROCHLORIDE, FLURAZEPAM HYDROCHLORIDE FLURBIPROFEN SODIUM, FLURBIPROFEN SODIUM FLURBIPROFEN, FLURBIPROFEN FLUTAMIDE, FLUTAMIDE FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE FML FORTE, FLUOROMETHOLONE FML, FLUOROMETHOLONE FOAMCOAT, ALUMINUM HYDROXIDE (OTC) FOCALIN XR, DEXMETHYLPHENIDATE HYDROCHLORIDE FOCALIN, DEXMETHYLPHENIDATE HYDROCHLORIDE FOLIC ACID, FOLIC ACID FOLLISTIM AQ, FOLLITROPIN ALFA/BETA FOLOTYN, PRALATREXATE FOMEPIZOLE, FOMEPIZOLE FONDAPARINUX SODIUM, FONDAPARINUX SODIUM FORADIL, FORMOTEROL FUMARATE FORANE, ISOFLURANE FORFIVO XL, BUPROPION HYDROCHLORIDE FORTAMET, METFORMIN HYDROCHLORIDE FORTAZ IN PLASTIC CONTAINER, CEFTAZIDIME SODIUM FORTAZ, CEFTAZIDIME FORTEO, TERIPARATIDE RECOMBINANT HUMAN FORTESTA, TESTOSTERONE FORTICAL, CALCITONIN SALMON RECOMBINANT FOSAMAX PLUS D, ALENDRONATE SODIUM FOSAMAX, ALENDRONATE SODIUM FOSCARNET SODIUM, FOSCARNET SODIUM FOSCAVIR, FOSCARNET SODIUM FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM FOSINOPRIL SODIUM, FOSINOPRIL SODIUM FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM FOSRENOL, LANTHANUM CARBONATE FRAGMIN, DALTEPARIN SODIUM FREAMINE HBC 6.9%, AMINO ACIDS FREAMINE III 10%, AMINO ACIDS FREAMINE III 3% W/ ELECTROLYTES, AMINO ACIDS FREAMINE III 8.5% W/ ELECTROLYTES, AMINO ACIDS FREAMINE III 8.5%, AMINO ACIDS FROVA, FROVATRIPTAN SUCCINATE FULCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER, FLUCONAZOLE FURADANTIN, NITROFURANTOIN FUROSEMIDE, FUROSEMIDE FUSILEV, LEVOLEUCOVORIN CALCIUM FUZEON, ENFUVIRTIDE

**
GABAPENTIN, GABAPENTIN GABITRIL, TIAGABINE HYDROCHLORIDE GABLOFEN, BACLOFEN

**

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

**

PRODUCT NAME INDEX

G **

A - 24

GADAVIST, GADOBUTROL GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE GALLIUM CITRATE GA 67, GALLIUM CITRATE GA-67 GALZIN, ZINC ACETATE GANCICLOVIR, GANCICLOVIR GANCICLOVIR, GANCICLOVIR SODIUM GANIRELIX ACETATE INJECTION, GANIRELIX ACETATE GANITE, GALLIUM NITRATE GASTROCROM, CROMOLYN SODIUM GASTROGRAFIN, DIATRIZOATE MEGLUMINE GASTROMARK, FERUMOXSIL GATIFLOXACIN, GATIFLOXACIN GAVISCON, ALUMINUM HYDROXIDE (OTC) GELNIQUE, OXYBUTYNIN CHLORIDE GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE GEMCITABINE, GEMCITABINE HYDROCHLORIDE GEMFIBROZIL, GEMFIBROZIL GEMZAR, GEMCITABINE HYDROCHLORIDE GENERLAC, LACTULOSE GENGRAF, CYCLOSPORINE GENOPTIC, GENTAMICIN SULFATE GENOTROPIN PRESERVATIVE FREE, SOMATROPIN RECOMBINANT GENOTROPIN, SOMATROPIN RECOMBINANT GENTAK, GENTAMICIN SULFATE GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, GENTAMICIN SULFATE GENTAMICIN SULFATE, GENTAMICIN SULFATE GEN-XENE, CLORAZEPATE DIPOTASSIUM GEODON, ZIPRASIDONE HYDROCHLORIDE GEODON, ZIPRASIDONE MESYLATE GILDESS FE 1.5/30, ETHINYL ESTRADIOL GILDESS FE 1/20, ETHINYL ESTRADIOL GILENYA, FINGOLIMOD GLEEVEC, IMATINIB MESYLATE GLIADEL, CARMUSTINE GLIMEPIRIDE, GLIMEPIRIDE GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE GLIPIZIDE, GLIPIZIDE GLUCAGEN, GLUCAGON HYDROCHLORIDE RECOMBINANT GLUCAGON, GLUCAGON RECOMBINANT GLUCOPHAGE XR, METFORMIN HYDROCHLORIDE GLUCOPHAGE, METFORMIN HYDROCHLORIDE GLUCOTROL XL, GLIPIZIDE GLUCOTROL, GLIPIZIDE GLUCOVANCE, GLYBURIDE GLUMETZA, METFORMIN HYDROCHLORIDE GLYBURIDE (MICRONIZED), GLYBURIDE GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE GLYBURIDE, GLYBURIDE GLYCINE 1.5% IN PLASTIC CONTAINER, GLYCINE GLYCOLAX, POLYETHYLENE GLYCOL 3350 GLYCOLAX, POLYETHYLENE GLYCOL 3350 (OTC) GLYCOPYRROLATE, GLYCOPYRROLATE GLYNASE, GLYBURIDE GLYSET, MIGLITOL GOLYTELY, POLYETHYLENE GLYCOL 3350 GONAL-F RFF PEN, FOLLITROPIN ALFA/BETA GONAL-F RFF, FOLLITROPIN ALFA/BETA GONAL-F, FOLLITROPIN ALFA/BETA GRALISE, GABAPENTIN GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE, GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE GRANISTERON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE GRIFULVIN V, GRISEOFULVIN, MICROCRYSTALLINE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

**

PRODUCT NAME INDEX

G **

A - 25

GRISEOFULVIN, GRISEOFULVIN GRISEOFULVIN, GRISEOFULVIN, MICROCRYSTALLINE GRIS-PEG, GRISEOFULVIN, ULTRAMICROCRYSTALLINE GUAIFENESIN, GUAIFENESIN (OTC) GUANABENZ ACETATE, GUANABENZ ACETATE GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE GUANIDINE HYDROCHLORIDE, GUANIDINE HYDROCHLORIDE GYNAZOLE-1, BUTOCONAZOLE NITRATE GYNE-LOTRIMIN 3 COMBINATION PACK, CLOTRIMAZOLE (OTC) GYNE-LOTRIMIN 3, CLOTRIMAZOLE (OTC) GYNE-LOTRIMIN COMBINATION PACK, CLOTRIMAZOLE (OTC) GYNE-LOTRIMIN, CLOTRIMAZOLE (OTC)

**

**

H.P. ACTHAR GEL, CORTICOTROPIN HABITROL, NICOTINE (OTC) HALAVEN, ERIBULIN MESYLATE HALCION, TRIAZOLAM HALDOL, HALOPERIDOL DECANOATE HALDOL, HALOPERIDOL LACTATE HALFLYTELY, BISACODYL HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE HALOG, HALCINONIDE HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE HALOPERIDOL, HALOPERIDOL HALOPERIDOL, HALOPERIDOL LACTATE HEATHER, NORETHINDRONE HECTOROL, DOXERCALCIFEROL HELIDAC, BISMUTH SUBSALICYLATE HEMABATE, CARBOPROST TROMETHAMINE HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN SODIUM HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN SODIUM HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, HEPARIN SODIUM HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN SODIUM HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN SODIUM HEPARIN SODIUM 20,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM HEPARIN SODIUM 25,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, HEPARIN SODIUM HEPARIN SODIUM IN PLASTIC CONTAINER, HEPARIN SODIUM HEPARIN SODIUM PRESERVATIVE FREE, HEPARIN SODIUM HEPARIN SODIUM, HEPARIN SODIUM HEPATAMINE 8%, AMINO ACIDS HEPATASOL 8%, AMINO ACIDS HEPATOLITE, TECHNETIUM TC-99M DISOFENIN KIT HEPSERA, ADEFOVIR DIPIVOXIL HERPLEX, IDOXURIDINE HEXABRIX, IOXAGLATE MEGLUMINE HEXALEN, ALTRETAMINE HIBICLENS, CHLORHEXIDINE GLUCONATE (OTC) HIBISTAT, CHLORHEXIDINE GLUCONATE (OTC) HICON, SODIUM IODIDE I-131 HIPREX, METHENAMINE HIPPURATE HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE, HOMATROPINE METHYLBROMIDE HORIZANT, GABAPENTIN ENACARBIL HUMALOG KWIKPEN, INSULIN LISPRO RECOMBINANT HUMALOG MIX 50/50 KWIKPEN, INSULIN LISPRO PROTAMINE RECOMBINANT HUMALOG MIX 50/50 PEN, INSULIN LISPRO PROTAMINE RECOMBINANT HUMALOG MIX 50/50, INSULIN LISPRO PROTAMINE RECOMBINANT HUMALOG MIX 75/25 KWIKPEN, INSULIN LISPRO PROTAMINE RECOMBINANT

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

**

PRODUCT NAME INDEX

H **

A - 26

HUMALOG MIX 75/25 PEN, INSULIN LISPRO PROTAMINE RECOMBINANT HUMALOG MIX 75/25, INSULIN LISPRO PROTAMINE RECOMBINANT HUMALOG PEN, INSULIN LISPRO RECOMBINANT HUMALOG, INSULIN LISPRO RECOMBINANT HUMATROPE, SOMATROPIN RECOMBINANT HUMULIN 70/30 PEN, INSULIN RECOMBINANT HUMAN (OTC) HUMULIN 70/30, INSULIN RECOMBINANT HUMAN (OTC) HUMULIN N, INSULIN SUSP ISOPHANE RECOMBINANT HUMAN (OTC) HUMULIN R PEN, INSULIN RECOMBINANT HUMAN (OTC) HUMULIN R, INSULIN RECOMBINANT HUMAN HUMULIN R, INSULIN RECOMBINANT HUMAN (OTC) HYCAMTIN, TOPOTECAN HYDROCHLORIDE HYDASE, HYALURONIDASE HYDERGINE, ERGOLOID MESYLATES HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE HYDRA-ZIDE, HYDRALAZINE HYDROCHLORIDE HYDREA, HYDROXYUREA HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE, HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATE AND IBUPROFEN, HYDROCODONE BITARTRATE HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX, CHLORPHENIRAMINE POLISTIREX HYDROCORTISONE ACETATE, HYDROCORTISONE ACETATE HYDROCORTISONE AND ACETIC ACID, ACETIC ACID, GLACIAL HYDROCORTISONE BUTYRATE, HYDROCORTISONE BUTYRATE HYDROCORTISONE IN ABSORBASE, HYDROCORTISONE HYDROCORTISONE VALERATE, HYDROCORTISONE VALERATE HYDROCORTISONE, HYDROCORTISONE HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE HYDRO-RX, HYDROCORTISONE HYDROXOCOBALAMIN, HYDROXOCOBALAMIN HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE HYDROXYUREA, HYDROXYUREA HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE HYDROXYZINE PAMOATE, HYDROXYZINE PAMOATE HYLENEX RECOMBINANT, HYALURONIDASE RECOMBINANT HUMAN HYTRIN, TERAZOSIN HYDROCHLORIDE HYZAAR, HYDROCHLOROTHIAZIDE

**

**

IBUPROFEN AND DIPHENHYDRAMINE CITRATE, DIPHENHYDRAMINE CITRATE (OTC) IBUPROFEN AND DIPHENHYDRAMINE, DIPHENHYDRAMINE HYDROCHLORIDE (OTC) IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE, IBUPROFEN (OTC) IBUPROFEN, IBUPROFEN IBUPROFEN, IBUPROFEN (OTC) IBUPROHM COLD AND SINUS, IBUPROFEN (OTC) IBUPROHM, IBUPROFEN (OTC) IBU-TAB 200, IBUPROFEN (OTC) IBU-TAB, IBUPROFEN IBUTILIDE FUMARATE, IBUTILIDE FUMARATE IC-GREEN, INDOCYANINE GREEN IDAMYCIN PFS, IDARUBICIN HYDROCHLORIDE IDARUBICIN HYDROCHLORIDE PFS, IDARUBICIN HYDROCHLORIDE IDARUBICIN HYDROCHLORIDE, IDARUBICIN HYDROCHLORIDE IDKIT:HP, UREA C-13 IFEX, IFOSFAMIDE IFOSFAMIDE, IFOSFAMIDE IFOSFAMIDE/MESNA KIT, IFOSFAMIDE IMIPENEM AND CILASTATIN, CILASTATIN SODIUM IMIPRAMINE HYDROCHLORIDE, IMIPRAMINE HYDROCHLORIDE IMIPRAMINE PAMOATE, IMIPRAMINE PAMOATE IMIQUIMOD, IMIQUIMOD IMITREX STATDOSE, SUMATRIPTAN SUCCINATE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

**

PRODUCT NAME INDEX

I **

A - 27

IMITREX, SUMATRIPTAN IMITREX, SUMATRIPTAN SUCCINATE IMODIUM A-D EZ CHEWS, LOPERAMIDE HYDROCHLORIDE (OTC) IMODIUM A-D, LOPERAMIDE HYDROCHLORIDE (OTC) IMODIUM MULTI-SYMPTOM RELIEF, LOPERAMIDE HYDROCHLORIDE (OTC) IMODIUM, LOPERAMIDE HYDROCHLORIDE IMPLANON, ETONOGESTREL IMURAN, AZATHIOPRINE INAPSINE, DROPERIDOL INCIVEK, TELAPREVIR INCRELEX, MECASERMIN RECOMBINANT INDAPAMIDE, INDAPAMIDE INDERAL LA, PROPRANOLOL HYDROCHLORIDE INDERAL, PROPRANOLOL HYDROCHLORIDE INDERIDE-40/25, HYDROCHLOROTHIAZIDE INDICLOR, INDIUM IN-111 CHLORIDE INDIUM IN 111 CHLORIDE, INDIUM IN-111 CHLORIDE INDIUM IN-111 OXYQUINOLINE, INDIUM IN-111 OXYQUINOLINE INDOCIN, INDOMETHACIN INDOCIN, INDOMETHACIN SODIUM INDOCYANINE GREEN, INDOCYANINE GREEN INDOMETHACIN SODIUM, INDOMETHACIN SODIUM INDOMETHACIN, INDOMETHACIN INFANTS' FEVERALL, ACETAMINOPHEN (OTC) INFASURF PRESERVATIVE FREE, CALFACTANT INFED, IRON DEXTRAN INFUMORPH, MORPHINE SULFATE INFUVITE ADULT, ALPHA-TOCOPHEROL ACETATE INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE), ASCORBIC ACID INFUVITE PEDIATRIC, ASCORBIC ACID INNOHEP, TINZAPARIN SODIUM INNOPRAN XL, PROPRANOLOL HYDROCHLORIDE INOMAX, NITRIC OXIDE INPERSOL-LC/LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE INPERSOL-LC/LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE INPERSOL-LC/LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE INPERSOL-LC/LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE INSPRA, EPLERENONE INTAL, CROMOLYN SODIUM INTEGRILIN, EPTIFIBATIDE INTELENCE, ETRAVIRINE INTERMEZZO, ZOLPIDEM TARTRATE INTRALIPID 10%, SOYBEAN OIL INTRALIPID 20%, SOYBEAN OIL INTRALIPID 30%, SOYBEAN OIL INTROVALE, ETHINYL ESTRADIOL INTUNIV, GUANFACINE HYDROCHLORIDE INVAGESIC FORTE, ASPIRIN INVAGESIC, ASPIRIN INVANZ, ERTAPENEM SODIUM INVEGA SUSTENNA, PALIPERIDONE PALMITATE INVEGA, PALIPERIDONE INVIRASE, SAQUINAVIR MESYLATE IONOSOL B AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE IONOSOL MB AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE IOPAMIDOL-250, IOPAMIDOL IOPAMIDOL-300, IOPAMIDOL IOPAMIDOL-370, IOPAMIDOL IOPIDINE, APRACLONIDINE HYDROCHLORIDE IOSAT, POTASSIUM IODIDE (OTC) IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE IPRIVASK, DESIRUDIN RECOMBINANT IQUIX, LEVOFLOXACIN

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

**

PRODUCT NAME INDEX

I **

A - 28

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE ISENTRESS, RALTEGRAVIR POTASSIUM ISOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN, LEVONORDEFRIN ISOCAINE HYDROCHLORIDE, MEPIVACAINE HYDROCHLORIDE ISOFLURANE, ISOFLURANE ISOLYTE E IN DEXTROSE 5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE ISOLYTE E IN PLASTIC CONTAINER, CALCIUM CHLORIDE ISOLYTE H IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE ISOLYTE M IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE ISOLYTE P IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE ISOLYTE R IN DEXTROSE 5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE ISOLYTE S IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE ISOLYTE S IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE ISOLYTE S PH 7.4 IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE ISONIAZID, ISONIAZID ISOPROTERENOL HYDROCHLORIDE, ISOPROTERENOL HYDROCHLORIDE ISOPTIN SR, VERAPAMIL HYDROCHLORIDE ISOPTO CARPINE, PILOCARPINE HYDROCHLORIDE ISORDIL, ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE ISOSULFAN BLUE, ISOSULFAN BLUE ISOTONIC GENTAMICIN SULFATE IN PLASTIC CONTAINER, GENTAMICIN SULFATE ISOVUE-200, IOPAMIDOL ISOVUE-250, IOPAMIDOL ISOVUE-300, IOPAMIDOL ISOVUE-370, IOPAMIDOL ISOVUE-M 200, IOPAMIDOL ISOVUE-M 300, IOPAMIDOL ISRADIPINE, ISRADIPINE ISTALOL, TIMOLOL MALEATE ISTODAX, ROMIDEPSIN ISUPREL, ISOPROTERENOL HYDROCHLORIDE ITRACONAZOLE, ITRACONAZOLE IVY BLOCK, BENTOQUATAM (OTC) IXEMPRA KIT, IXABEPILONE

**
JAKAFI, RUXOLITINIB PHOSPHATE JALYN, DUTASTERIDE JANTOVEN, WARFARIN SODIUM JANUMET, METFORMIN HYDROCHLORIDE JANUVIA, SITAGLIPTIN PHOSPHATE JEANATOPE, ALBUMIN IODINATED I-125 SERUM JEVTANA KIT, CABAZITAXEL JUNEL 1.5/30, ETHINYL ESTRADIOL JUNEL 1/20, ETHINYL ESTRADIOL JUNEL FE 1.5/30, ETHINYL ESTRADIOL JUNEL FE 1/20, ETHINYL ESTRADIOL JUNIOR STRENGTH ADVIL, IBUPROFEN (OTC) JUNIOR STRENGTH IBUPROFEN, IBUPROFEN (OTC) JUNIOR STRENGTH MOTRIN, IBUPROFEN (OTC) JUVISYNC, SIMVASTATIN

**

**
K+10, POTASSIUM CHLORIDE KADIAN, MORPHINE SULFATE KALETRA, LOPINAVIR KALEXATE, SODIUM POLYSTYRENE SULFONATE KANAMYCIN SULFATE, KANAMYCIN SULFATE KAON CL-10, POTASSIUM CHLORIDE KAPVAY, CLONIDINE HYDROCHLORIDE

**

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

**

PRODUCT NAME INDEX

K **

A - 29

KARIVA, DESOGESTREL KAYEXALATE, SODIUM POLYSTYRENE SULFONATE KEFLEX, CEPHALEXIN KEFZOL, CEFAZOLIN SODIUM KELNOR, ETHINYL ESTRADIOL KENALOG, TRIAMCINOLONE ACETONIDE KENALOG-10, TRIAMCINOLONE ACETONIDE KENALOG-40, TRIAMCINOLONE ACETONIDE KEPPRA XR, LEVETIRACETAM KEPPRA, LEVETIRACETAM KETALAR, KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE, KETAMINE HYDROCHLORIDE KETEK, TELITHROMYCIN KETOCONAZOLE, KETOCONAZOLE KETOPROFEN, KETOPROFEN KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE KETOTIFEN FUMARATE, KETOTIFEN FUMARATE (OTC) KETOZOLE, KETOCONAZOLE KINEVAC, SINCALIDE KIONEX, SODIUM POLYSTYRENE SULFONATE KLARON, SULFACETAMIDE SODIUM KLONOPIN, CLONAZEPAM KLOR-CON M10, POTASSIUM CHLORIDE KLOR-CON M15, POTASSIUM CHLORIDE KLOR-CON M20, POTASSIUM CHLORIDE KLOR-CON, POTASSIUM CHLORIDE KLOTRIX, POTASSIUM CHLORIDE KOMBIGLYZE XR, METFORMIN HYDROCHLORIDE K-TAB, POTASSIUM CHLORIDE KUVAN, SAPROPTERIN DIHYDROCHLORIDE

**

**

LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE LABETALOL HYDROCLORIDE, LABETALOL HYDROCHLORIDE LAC-HYDRIN, AMMONIUM LACTATE LACRISERT, HYDROXYPROPYL CELLULOSE LACTATED RINGER'S AND DEXTROSE 5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE LACTULOSE, LACTULOSE LAMICTAL CD, LAMOTRIGINE LAMICTAL ODT, LAMOTRIGINE LAMICTAL XR, LAMOTRIGINE LAMICTAL, LAMOTRIGINE LAMISIL AT, TERBINAFINE (OTC) LAMISIL AT, TERBINAFINE HYDROCHLORIDE (OTC) LAMISIL, TERBINAFINE HYDROCHLORIDE LAMISIL, TERBINAFINE HYDROCHLORIDE (OTC) LAMIVUDINE AND ZIDOVUDINE, LAMIVUDINE LAMIVUDINE, LAMIVUDINE LAMOTRIGINE, LAMOTRIGINE LAMPRENE, CLOFAZIMINE LANORINAL, ASPIRIN LANOXIN PEDIATRIC, DIGOXIN LANOXIN, DIGOXIN LANSOPRAZOLE, LANSOPRAZOLE LANTUS, INSULIN GLARGINE RECOMBINANT LAROTID, AMOXICILLIN LARYNG-O-JET KIT, LIDOCAINE HYDROCHLORIDE LASIX, FUROSEMIDE LASTACAFT, ALCAFTADINE LATANOPROST, LATANOPROST LATISSE, BIMATOPROST LATUDA, LURASIDONE HYDROCHLORIDE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

**

PRODUCT NAME INDEX

L **

A - 30

LAX-LYTE WITH FLAVOR PACKS, POLYETHYLENE GLYCOL 3350 LAZANDA, FENTANYL CITRATE LEFLUNOMIDE, LEFLUNOMIDE LESCOL XL, FLUVASTATIN SODIUM LESCOL, FLUVASTATIN SODIUM LESSINA-28, ETHINYL ESTRADIOL LETAIRIS, AMBRISENTAN LETROZOLE, LETROZOLE LEUCOVORIN CALCIUM PRESERVATIVE FREE, LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM LEUKERAN, CHLORAMBUCIL LEUPROLIDE ACETATE, LEUPROLIDE ACETATE LEUSTATIN, CLADRIBINE LEVALBUTEROL HYDROCHLORIDE, LEVALBUTEROL HYDROCHLORIDE LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN LEVAQUIN, LEVOFLOXACIN LEVATOL, PENBUTOLOL SULFATE LEVEMIR, INSULIN DETEMIR RECOMBINANT LEVETIRACETAM IN SODIUM CHLORIDE, LEVETIRACETAM LEVETIRACETAM, LEVETIRACETAM LEVITRA, VARDENAFIL HYDROCHLORIDE LEVOBUNOLOL HYDROCHLORIDE, LEVOBUNOLOL HYDROCHLORIDE LEVOCARNITINE, LEVOCARNITINE LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN LEVOFLOXACIN, LEVOFLOXACIN LEVONEST, ETHINYL ESTRADIOL LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL LEVONORGESTREL, LEVONORGESTREL LEVONORGESTREL, LEVONORGESTREL (OTC) LEVOPHED, NOREPINEPHRINE BITARTRATE LEVORA 0.15/30-28, ETHINYL ESTRADIOL LEVORPHANOL TARTRATE, LEVORPHANOL TARTRATE LEVO-T, LEVOTHYROXINE SODIUM LEVOTHROID, LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM LEVOXYL, LEVOTHYROXINE SODIUM LEVULAN, AMINOLEVULINIC ACID HYDROCHLORIDE LEXAPRO, ESCITALOPRAM OXALATE LEXISCAN, REGADENOSON LEXIVA, FOSAMPRENAVIR CALCIUM LIALDA, MESALAMINE LIBRIUM, CHLORDIAZEPOXIDE HYDROCHLORIDE LIDEX, FLUOCINONIDE LIDEX-E, FLUOCINONIDE LIDOCAINE AND PRILOCAINE, LIDOCAINE LIDOCAINE AND TETRACAINE, LIDOCAINE LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 0.8% IN DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 5% AND DEXTROSE 7.5%, LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE, EPINEPHRINE LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE VISCOUS, LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE LIDOCAINE VISCOUS, LIDOCAINE HYDROCHLORIDE LIDOCAINE, LIDOCAINE LIDODERM, LIDOCAINE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

**

PRODUCT NAME INDEX

L **

A - 31

LIDOPEN, LIDOCAINE HYDROCHLORIDE LIGNOSPAN FORTE, EPINEPHRINE BITARTRATE LIGNOSPAN STANDARD, EPINEPHRINE BITARTRATE LIMBITROL DS, AMITRIPTYLINE HYDROCHLORIDE LIMBITROL, AMITRIPTYLINE HYDROCHLORIDE LINCOCIN, LINCOMYCIN HYDROCHLORIDE LINDANE, LINDANE LIORESAL, BACLOFEN LIOTHYRONINE SODIUM, LIOTHYRONINE SODIUM LIPITOR, ATORVASTATIN CALCIUM LIPOFEN, FENOFIBRATE LIPOSYN II 10%, SAFFLOWER OIL LIPOSYN II 20%, SAFFLOWER OIL LIPOSYN III 10%, SOYBEAN OIL LIPOSYN III 20%, SOYBEAN OIL LIPOSYN III 30%, SOYBEAN OIL LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LISINOPRIL, LISINOPRIL LITHIUM CARBONATE, LITHIUM CARBONATE LITHIUM CITRATE, LITHIUM CITRATE LITHOBID, LITHIUM CARBONATE LITHOSTAT, ACETOHYDROXAMIC ACID LIVALO, PITAVASTATIN CALCIUM LO LOESTRIN FE, ETHINYL ESTRADIOL LO/OVRAL-28, ETHINYL ESTRADIOL LOCHOLEST LIGHT, CHOLESTYRAMINE LOCHOLEST, CHOLESTYRAMINE LOCOID LIPOCREAM, HYDROCORTISONE BUTYRATE LOCOID, HYDROCORTISONE BUTYRATE LODOSYN, CARBIDOPA LOESTRIN 21 1.5/30, ETHINYL ESTRADIOL LOESTRIN 21 1/20, ETHINYL ESTRADIOL LOESTRIN 24 FE, ETHINYL ESTRADIOL LOESTRIN FE 1.5/30, ETHINYL ESTRADIOL LOESTRIN FE 1/20, ETHINYL ESTRADIOL LOMOTIL, ATROPINE SULFATE LONOX, ATROPINE SULFATE LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE, LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC) LOPID, GEMFIBROZIL LOPRESSOR HCT, HYDROCHLOROTHIAZIDE LOPRESSOR, METOPROLOL TARTRATE LOPROX, CICLOPIROX LOPURIN, ALLOPURINOL LORATADINE AND PSEUDOEPHEDRINE SULFATE, LORATADINE (OTC) LORATADINE REDIDOSE, LORATADINE (OTC) LORATADINE, LORATADINE (OTC) LORAZEPAM INTENSOL, LORAZEPAM LORAZEPAM PRESERVATIVE FREE, LORAZEPAM LORAZEPAM, LORAZEPAM LORTAB, ACETAMINOPHEN LORYNA, DROSPIRENONE LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM, LOSARTAN POTASSIUM LOSEASONIQUE, ETHINYL ESTRADIOL LOTEMAX, LOTEPREDNOL ETABONATE LOTENSIN HCT, BENAZEPRIL HYDROCHLORIDE LOTENSIN, BENAZEPRIL HYDROCHLORIDE LOTREL, AMLODIPINE BESYLATE LOTRIMIN ULTRA, BUTENAFINE HYDROCHLORIDE (OTC) LOTRISONE, BETAMETHASONE DIPROPIONATE LOTRONEX, ALOSETRON HYDROCHLORIDE

(OTC)

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

**

PRODUCT NAME INDEX

L **

A - 32

LOVASTATIN, LOVASTATIN LOVAZA, OMEGA-3-ACID ETHYL ESTERS LOVENOX (PRESERVATIVE FREE), ENOXAPARIN SODIUM LOVENOX, ENOXAPARIN SODIUM LOW-OGESTREL-21, ETHINYL ESTRADIOL LOW-OGESTREL-28, ETHINYL ESTRADIOL LOXAPINE SUCCINATE, LOXAPINE SUCCINATE LTA II KIT, LIDOCAINE HYDROCHLORIDE LUFYLLIN, DYPHYLLINE LUMIGAN, BIMATOPROST LUNESTA, ESZOPICLONE LUPRON DEPOT, LEUPROLIDE ACETATE LUPRON DEPOT-PED, LEUPROLIDE ACETATE LUSEDRA, FOSPROPOFOL DISODIUM LUVERIS, LUTROPIN ALFA LUVOX CR, FLUVOXAMINE MALEATE LUVOX, FLUVOXAMINE MALEATE LUXIQ, BETAMETHASONE VALERATE LYBREL, ETHINYL ESTRADIOL LYMPHAZURIN, ISOSULFAN BLUE LYRICA, PREGABALIN LYSODREN, MITOTANE LYSTEDA, TRANEXAMIC ACID

**

**

M.V.I. ADULT (PHARMACY BULK PACKAGE), ASCORBIC ACID M.V.I. ADULT, ASCORBIC ACID M.V.I. PEDIATRIC, ASCORBIC ACID M.V.I.-12 (WITHOUT VITAMIN K), ASCORBIC ACID MACROBID, NITROFURANTOIN MACRODANTIN, NITROFURANTOIN, MACROCRYSTALLINE MACUGEN, PEGAPTANIB SODIUM MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE, MAGNESIUM HYDROXIDE MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MAGNESIUM SULFATE MAGNESIUM SULFATE IN PLASTIC CONTAINER, MAGNESIUM SULFATE MAGNESIUM SULFATE, MAGNESIUM SULFATE MAGNEVIST, GADOPENTETATE DIMEGLUMINE MAKENA, HYDROXYPROGESTERONE CAPROATE MALARONE PEDIATRIC, ATOVAQUONE MALARONE, ATOVAQUONE MALATHION, MALATHION MANGANESE CHLORIDE IN PLASTIC CONTAINER, MANGANESE CHLORIDE MANNITOL 10% IN PLASTIC CONTAINER, MANNITOL MANNITOL 10% W/ DEXTROSE 5% IN DISTILLED WATER, MANNITOL MANNITOL 10%, MANNITOL MANNITOL 15% IN PLASTIC CONTAINER, MANNITOL MANNITOL 15% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.45%, MANNITOL MANNITOL 15%, MANNITOL MANNITOL 20% IN PLASTIC CONTAINER, MANNITOL MANNITOL 20%, MANNITOL MANNITOL 25%, MANNITOL MANNITOL 5% IN PLASTIC CONTAINER, MANNITOL MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12%, MANNITOL MANNITOL 5%, MANNITOL MAPROTILINE HYDROCHLORIDE, MAPROTILINE HYDROCHLORIDE MARCAINE HYDROCHLORIDE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE MARCAINE HYDROCHLORIDE W/ EPINEPHRINE, BUPIVACAINE HYDROCHLORIDE MARCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE MARCAINE, BUPIVACAINE HYDROCHLORIDE MARINOL, DRONABINOL MARPLAN, ISOCARBOXAZID MATULANE, PROCARBAZINE HYDROCHLORIDE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

**

PRODUCT NAME INDEX

M **

A - 33

MAVIK, TRANDOLAPRIL MAXAIR, PIRBUTEROL ACETATE MAXALT, RIZATRIPTAN BENZOATE MAXALT-MLT, RIZATRIPTAN BENZOATE MAXIDEX, DEXAMETHASONE MAXIPIME, CEFEPIME HYDROCHLORIDE MAXITROL, DEXAMETHASONE MAXZIDE, HYDROCHLOROTHIAZIDE MAXZIDE-25, HYDROCHLOROTHIAZIDE MD-76R, DIATRIZOATE MEGLUMINE MD-GASTROVIEW, DIATRIZOATE MEGLUMINE MDP-BRACCO, TECHNETIUM TC-99M MEDRONATE KIT MEBENDAZOLE, MEBENDAZOLE MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE MECLOFENAMATE SODIUM, MECLOFENAMATE SODIUM MEDROL, METHYLPREDNISOLONE MEDROXYPROGESTERONE ACETATE, MEDROXYPROGESTERONE ACETATE MEFENAMIC ACID, MEFENAMIC ACID MEFLOQUINE HYDROCHLORIDE, MEFLOQUINE HYDROCHLORIDE MEFOXIN IN PLASTIC CONTAINER, CEFOXITIN SODIUM MEGACE ES, MEGESTROL ACETATE MEGACE, MEGESTROL ACETATE MEGATOPE, ALBUMIN IODINATED I-131 SERUM MEGESTROL ACETATE, MEGESTROL ACETATE MELOXICAM, MELOXICAM MELPHALAN HYDROCHLORIDE, MELPHALAN HYDROCHLORIDE MEMBRANEBLUE, TRYPAN BLUE MENEST, ESTROGENS, ESTERIFIED MENOPUR, LUTEINIZING HORMONE MENOSTAR, ESTRADIOL MEN'S ROGAINE, MINOXIDIL (OTC) MENTAX, BUTENAFINE HYDROCHLORIDE MENTAX-TC, BUTENAFINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE, MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE MEPHYTON, PHYTONADIONE MEPIVACAINE HYDROCHLORIDE, MEPIVACAINE HYDROCHLORIDE MEPROBAMATE, MEPROBAMATE MEPRON, ATOVAQUONE MERCAPTOPURINE, MERCAPTOPURINE MEROPENEM, MEROPENEM MERREM, MEROPENEM MESALAMINE, MESALAMINE MESNA, MESNA MESNEX, MESNA MESTINON, PYRIDOSTIGMINE BROMIDE METADATE CD, METHYLPHENIDATE HYDROCHLORIDE METADATE ER, METHYLPHENIDATE HYDROCHLORIDE METAPROTERENOL SULFATE, METAPROTERENOL SULFATE METARAMINOL BITARTRATE, METARAMINOL BITARTRATE METASTRON, STRONTIUM CHLORIDE SR-89 METAXALONE, METAXALONE METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE METHADONE HYDROCHLORIDE INTENSOL, METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE METHADOSE, METHADONE HYDROCHLORIDE METHAMPHETAMINE HYDROCHLORIDE, METHAMPHETAMINE HYDROCHLORIDE METHAZOLAMIDE, METHAZOLAMIDE METHENAMINE HIPPURATE, METHENAMINE HIPPURATE METHERGINE, METHYLERGONOVINE MALEATE METHIMAZOLE, METHIMAZOLE METHOCARBAMOL AND ASPIRIN, ASPIRIN METHOCARBAMOL, METHOCARBAMOL

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

**

PRODUCT NAME INDEX

M **

A - 34

METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM METHOTREXATE SODIUM, METHOTREXATE SODIUM METHSCOPOLAMINE BROMIDE, METHSCOPOLAMINE BROMIDE METHYCLOTHIAZIDE, METHYCLOTHIAZIDE METHYLDOPA AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE METHYLDOPA, METHYLDOPA METHYLDOPATE HYDROCHLORIDE, METHYLDOPATE HYDROCHLORIDE METHYLERGONOVINE MALEATE, METHYLERGONOVINE MALEATE METHYLIN ER, METHYLPHENIDATE HYDROCHLORIDE METHYLIN, METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE METHYLPREDNISOLONE ACETATE, METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE, METHYLPREDNISOLONE METHYLTESTOSTERONE, METHYLTESTOSTERONE METIPRANOLOL, METIPRANOLOL HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE METOLAZONE, METOLAZONE METOPIRONE, METYRAPONE METOPROLOL SUCCINATE, METOPROLOL SUCCINATE METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE METOPROLOL TARTRATE, METOPROLOL TARTRATE METOZOLV ODT, METOCLOPRAMIDE HYDROCHLORIDE METRO I.V. IN PLASTIC CONTAINER, METRONIDAZOLE METROCREAM, METRONIDAZOLE METROGEL, METRONIDAZOLE METROGEL-VAGINAL, METRONIDAZOLE METROLOTION, METRONIDAZOLE METRONIDAZOLE IN PLASTIC CONTAINER, METRONIDAZOLE METRONIDAZOLE, METRONIDAZOLE METVIXIA, METHYL AMINOLEVULINATE HYDROCHLORIDE MEVACOR, LOVASTATIN MEXILETINE HYDROCHLORIDE, MEXILETINE HYDROCHLORIDE MIACALCIN, CALCITONIN SALMON MICARDIS HCT, HYDROCHLOROTHIAZIDE MICARDIS, TELMISARTAN MICONAZOLE 3 COMBINATION PACK, MICONAZOLE NITRATE (OTC) MICONAZOLE 3, MICONAZOLE NITRATE (OTC) MICONAZOLE 7 COMBINATION PACK, MICONAZOLE NITRATE (OTC) MICONAZOLE 7, MICONAZOLE NITRATE (OTC) MICONAZOLE NITRATE COMBINATION PACK, MICONAZOLE NITRATE (OTC) MICONAZOLE NITRATE, MICONAZOLE NITRATE MICONAZOLE NITRATE, MICONAZOLE NITRATE (OTC) MICORT-HC, HYDROCORTISONE ACETATE MICROGESTIN 1.5/30, ETHINYL ESTRADIOL MICROGESTIN 1/20, ETHINYL ESTRADIOL MICROGESTIN FE 1.5/30, ETHINYL ESTRADIOL MICROGESTIN FE 1/20, ETHINYL ESTRADIOL MICRO-K 10, POTASSIUM CHLORIDE MICRO-K, POTASSIUM CHLORIDE MICRONOR, NORETHINDRONE MICROZIDE, HYDROCHLOROTHIAZIDE MIDAMOR, AMILORIDE HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE, MIDAZOLAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE MIDOL LIQUID GELS, IBUPROFEN (OTC) MIDOZALAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE MIFEPREX, MIFEPRISTONE MIGERGOT, CAFFEINE MIGRANAL, DIHYDROERGOTAMINE MESYLATE MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MILRINONE LACTATE MILRINONE LACTATE IN DEXTROSE 5%, MILRINONE LACTATE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

**

PRODUCT NAME INDEX

M **

A - 35

MILRINONE LACTATE IN PLASTIC CONTAINER, MILRINONE LACTATE MILRINONE LACTATE, MILRINONE LACTATE MINIPRESS, PRAZOSIN HYDROCHLORIDE MINIRIN, DESMOPRESSIN ACETATE MINITRAN, NITROGLYCERIN MINOCIN, MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE MINOXIDIL (FOR MEN), MINOXIDIL (OTC) MINOXIDIL (FOR WOMEN), MINOXIDIL (OTC) MINOXIDIL EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC) MINOXIDIL, MINOXIDIL MINOXIDIL, MINOXIDIL (OTC) MIOCHOL-E, ACETYLCHOLINE CHLORIDE MIOSTAT, CARBACHOL MIRALAX, POLYETHYLENE GLYCOL 3350 (OTC) MIRAPEX ER, PRAMIPEXOLE DIHYDROCHLORIDE MIRAPEX, PRAMIPEXOLE DIHYDROCHLORIDE MIRCETTE, DESOGESTREL MIRENA, LEVONORGESTREL MIRTAZAPINE, MIRTAZAPINE MISOPROSTOL, MISOPROSTOL MITOMYCIN, MITOMYCIN MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE MOBIC, MELOXICAM MODICON 28, ETHINYL ESTRADIOL MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE MOEXIPRIL HYDROCHLORIDE, MOEXIPRIL HYDROCHLORIDE MOMETASONE FUROATE, MOMETASONE FUROATE MONISTAT 1 COMBINATION PACK, MICONAZOLE NITRATE (OTC) MONISTAT 3 COMBINATION PACK (PREFILLED), MICONAZOLE NITRATE (OTC) MONISTAT 3 COMBINATION PACK, MICONAZOLE NITRATE (OTC) MONISTAT 3, MICONAZOLE NITRATE MONISTAT 3, MICONAZOLE NITRATE (OTC) MONISTAT 7 COMBINATION PACK, MICONAZOLE NITRATE (OTC) MONISTAT 7, MICONAZOLE NITRATE (OTC) MONISTAT-3 COMBINATION PACK, MICONAZOLE NITRATE (OTC) MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE, SODIUM PHOSPHATE, DIBASIC, ANHYDROUS MONODOX, DOXYCYCLINE MONOKET, ISOSORBIDE MONONITRATE MONOPRIL, FOSINOPRIL SODIUM MONUROL, FOSFOMYCIN TROMETHAMINE MORPHINE SULFATE, MORPHINE SULFATE MOTOFEN, ATROPINE SULFATE MOTRIN IB, IBUPROFEN (OTC) MOTRIN MIGRAINE PAIN, IBUPROFEN (OTC) MOVIPREP, ASCORBIC ACID MOXATAG, AMOXICILLIN MOXEZA, MOXIFLOXACIN HYDROCHLORIDE MOZOBIL, PLERIXAFOR MPI DMSA KIDNEY REAGENT, TECHNETIUM TC-99M SUCCIMER KIT MPI INDIUM DTPA IN 111, INDIUM IN-111 PENTETATE DISODIUM MS CONTIN, MORPHINE SULFATE MUCINEX D, GUAIFENESIN (OTC) MUCINEX DM, DEXTROMETHORPHAN HYDROBROMIDE (OTC) MUCINEX, GUAIFENESIN (OTC) MULTAQ, DRONEDARONE HYDROCHLORIDE MULTIHANCE MULTIPACK, GADOBENATE DIMEGLUMINE MULTIHANCE, GADOBENATE DIMEGLUMINE MUPIROCIN, MUPIROCIN MUSE, ALPROSTADIL MUSTARGEN, MECHLORETHAMINE HYDROCHLORIDE MYAMBUTOL, ETHAMBUTOL HYDROCHLORIDE MYCAMINE, MICAFUNGIN SODIUM

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

**

PRODUCT NAME INDEX

M **

A - 36

MYCELEX, CLOTRIMAZOLE MYCELEX-7 COMBINATION PACK, CLOTRIMAZOLE (OTC) MYCELEX-7, CLOTRIMAZOLE (OTC) MYCOBUTIN, RIFABUTIN MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL MYDRIACYL, TROPICAMIDE MYFORTIC, MYCOPHENOLIC ACID MYLERAN, BUSULFAN MYOVIEW 30ML, TECHNETIUM TC-99M TETROFOSMIN KIT MYOVIEW, TECHNETIUM TC-99M TETROFOSMIN KIT MYSOLINE, PRIMIDONE MYTELASE, AMBENONIUM CHLORIDE M-ZOLE 3 COMBINATION PACK, MICONAZOLE NITRATE (OTC)

**

**

NABUMETONE, NABUMETONE NADOLOL AND BENDROFLUMETHAZIDE, BENDROFLUMETHIAZIDE NADOLOL AND BENDROFLUMETHIAZIDE, BENDROFLUMETHIAZIDE NADOLOL, NADOLOL NAFCILLIN SODIUM, NAFCILLIN SODIUM NAFTIN, NAFTIFINE HYDROCHLORIDE NALBUPHINE HYDROCHLORIDE, NALBUPHINE HYDROCHLORIDE NALFON, FENOPROFEN CALCIUM NALLPEN IN PLASTIC CONTAINER, NAFCILLIN SODIUM NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE NAMENDA XR, MEMANTINE HYDROCHLORIDE NAMENDA, MEMANTINE HYDROCHLORIDE NANDROLONE DECANOATE, NANDROLONE DECANOATE NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE, NAPHAZOLINE HYDROCHLORIDE (OTC) NAPHAZOLINE HYDROCHLORIDE, NAPHAZOLINE HYDROCHLORIDE NAPHCON-A, NAPHAZOLINE HYDROCHLORIDE (OTC) NAPRELAN, NAPROXEN SODIUM NAPROSYN, NAPROXEN NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE, NAPROXEN SODIUM (OTC) NAPROXEN SODIUM, NAPROXEN SODIUM NAPROXEN SODIUM, NAPROXEN SODIUM (OTC) NAPROXEN, NAPROXEN NARATRIPTAN, NARATRIPTAN NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE NARDIL, PHENELZINE SULFATE NAROPIN, ROPIVACAINE HYDROCHLORIDE MONOHYDRATE NASACORT AQ, TRIAMCINOLONE ACETONIDE NASCOBAL, CYANOCOBALAMIN NASONEX, MOMETASONE FUROATE MONOHYDRATE NATACYN, NATAMYCIN NATAZIA, ESTRADIOL VALERATE NATEGLINIDE, NATEGLINIDE NATRECOR, NESIRITIDE RECOMBINANT NATROBA, SPINOSAD NAVANE, THIOTHIXENE NAVELBINE, VINORELBINE TARTRATE NAVSTEL, CALCIUM CHLORIDE NEBUPENT, PENTAMIDINE ISETHIONATE NEFAZODONE HYDROCHLORIDE, NEFAZODONE HYDROCHLORIDE NEMBUTAL SODIUM, PENTOBARBITAL SODIUM NEO-FRADIN, NEOMYCIN SULFATE NEOMYCIN AND POLYMYXIN B SULFATE, NEOMYCIN SULFATE NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC, BACITRACIN ZINC NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE, DEXAMETHASONE NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN, GRAMICIDIN NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE, HYDROCORTISONE NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE, BACITRACIN ZINC

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

**

PRODUCT NAME INDEX

N **

A - 37

NEOMYCIN SULFATE, NEOMYCIN SULFATE NEOPAP, ACETAMINOPHEN (OTC) NEOPROFEN, IBUPROFEN LYSINE NEORAL, CYCLOSPORINE NEO-RX, NEOMYCIN SULFATE NEOSPORIN G.U. IRRIGANT, NEOMYCIN SULFATE NEOSPORIN, GRAMICIDIN NEPHRAMINE 5.4%, AMINO ACIDS NESACAINE, CHLOROPROCAINE HYDROCHLORIDE NESACAINE-MPF, CHLOROPROCAINE HYDROCHLORIDE NEUROLITE, TECHNETIUM TC-99M BICISATE KIT NEURONTIN, GABAPENTIN NEVANAC, NEPAFENAC NEXAVAR, SORAFENIB TOSYLATE NEXCEDE, KETOPROFEN (OTC) NEXIUM IV, ESOMEPRAZOLE SODIUM NEXIUM, ESOMEPRAZOLE MAGNESIUM NEXPLANON, ETONOGESTREL NEXTERONE, AMIODARONE HYDROCHLORIDE NIACIN, NIACIN NIACOR, NIACIN NIASPAN, NIACIN NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE NICODERM CQ, NICOTINE (OTC) NICORETTE (MINT), NICOTINE POLACRILEX (OTC) NICORETTE, NICOTINE POLACRILEX (OTC) NICOTINE POLACRILEX, NICOTINE POLACRILEX (OTC) NICOTINE, NICOTINE (OTC) NICOTROL, NICOTINE NIFEDIPINE, NIFEDIPINE NILANDRON, NILUTAMIDE NILSTAT, NYSTATIN NIMBEX PRESERVATIVE FREE, CISATRACURIUM BESYLATE NIMBEX, CISATRACURIUM BESYLATE NIMODIPINE, NIMODIPINE NIPENT, PENTOSTATIN NIRAVAM, ALPRAZOLAM NISOLDIPINE, NISOLDIPINE NITHIODOTE, SODIUM NITRITE NITRO-DUR, NITROGLYCERIN NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS), NITROFURANTOIN NITROFURANTOIN, NITROFURANTOIN NITROFURANTOIN, NITROFURANTOIN, MACROCRYSTALLINE NITROGLYCERIN IN DEXTROSE 5%, NITROGLYCERIN NITROGLYCERIN, NITROGLYCERIN NITROLINGUAL PUMPSPRAY, NITROGLYCERIN NITROMIST, NITROGLYCERIN NITROPRESS, SODIUM NITROPRUSSIDE NITROSTAT, NITROGLYCERIN NIX, PERMETHRIN (OTC) NIZATIDINE, NIZATIDINE NIZORAL A-D, KETOCONAZOLE (OTC) NIZORAL, KETOCONAZOLE NORCO, ACETAMINOPHEN NORDETTE-28, ETHINYL ESTRADIOL NORDITROPIN FLEXPRO, SOMATROPIN RECOMBINANT NORDITROPIN NORDIFLEX, SOMATROPIN RECOMBINANT NORDITROPIN, SOMATROPIN RECOMBINANT NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE NORETHIDRONE, NORETHINDRONE NORETHIN 1/35E-21, ETHINYL ESTRADIOL NORETHIN 1/35E-28, ETHINYL ESTRADIOL NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

**

PRODUCT NAME INDEX

N **

A - 38

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL NORETHINDRONE ACETATE, NORETHINDRONE ACETATE NORETHINDRONE AND ETHINYL ESTRADIOL (10/11), ETHINYL ESTRADIOL NORETHINDRONE AND ETHINYL ESTRADIOL (7/14), ETHINYL ESTRADIOL NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL NORETHINDRONE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL NORETHINDRONE, NORETHINDRONE NORFLEX, ORPHENADRINE CITRATE NORGESIC FORTE, ASPIRIN NORGESIC, ASPIRIN NORGESTIMATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL NORINYL 1+35 21-DAY, ETHINYL ESTRADIOL NORINYL 1+35 28-DAY, ETHINYL ESTRADIOL NORINYL 1+50 28-DAY, MESTRANOL NORITATE, METRONIDAZOLE NORMOCARB HF 25, MAGNESIUM CHLORIDE NORMOCARB HF 35, MAGNESIUM CHLORIDE NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE NORMOSOL-R IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE NOROXIN, NORFLOXACIN NORPACE CR, DISOPYRAMIDE PHOSPHATE NORPACE, DISOPYRAMIDE PHOSPHATE NORPRAMIN, DESIPRAMINE HYDROCHLORIDE NOR-QD, NORETHINDRONE NORTREL 0.5/35-28, ETHINYL ESTRADIOL NORTREL 1/35-21, ETHINYL ESTRADIOL NORTREL 1/35-28, ETHINYL ESTRADIOL NORTREL 7/7/7, ETHINYL ESTRADIOL NORTRIPTYLINE HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE NORVASC, AMLODIPINE BESYLATE NORVIR, RITONAVIR NOVOLIN 70/30, INSULIN RECOMBINANT HUMAN (OTC) NOVOLIN N, INSULIN SUSP ISOPHANE RECOMBINANT HUMAN (OTC) NOVOLIN R, INSULIN RECOMBINANT HUMAN (OTC) NOVOLOG MIX 70/30, INSULIN ASPART PROTAMINE RECOMBINANT NOVOLOG, INSULIN ASPART RECOMBINANT NOXAFIL, POSACONAZOLE NUCYNTA ER, TAPENTADOL HYDROCHLORIDE NUCYNTA, TAPENTADOL HYDROCHLORIDE NUEDEXTA, DEXTROMETHORPHAN HYDROBROMIDE NULYTELY, POLYETHYLENE GLYCOL 3350 NULYTELY-FLAVORED, POLYETHYLENE GLYCOL 3350 NUTRACORT, HYDROCORTISONE NUTRESTORE, GLUTAMINE NUTRILIPID 10%, SOYBEAN OIL NUTRILIPID 20%, SOYBEAN OIL NUTROPIN AQ PEN, SOMATROPIN RECOMBINANT NUTROPIN AQ, SOMATROPIN RECOMBINANT NUTROPIN, SOMATROPIN RECOMBINANT NUVARING, ETHINYL ESTRADIOL NUVIGIL, ARMODAFINIL NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN NYSTATIN, NYSTATIN NYSTOP, NYSTATIN

**

**

OCTOCAINE, EPINEPHRINE OCTREOSCAN, INDIUM IN-111 PENTETREOTIDE KIT OCTREOTIDE ACETATE (PRESERVATIVE FREE), OCTREOTIDE ACETATE OCTREOTIDE ACETATE, OCTREOTIDE ACETATE OCUCLEAR, OXYMETAZOLINE HYDROCHLORIDE (OTC) OCUFEN, FLURBIPROFEN SODIUM

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

**

PRODUCT NAME INDEX

O **

A - 39

OCUFLOX, OFLOXACIN OCUPRESS, CARTEOLOL HYDROCHLORIDE OFIRMEV, ACETAMINOPHEN OFLOXACIN, OFLOXACIN OFORTA, FLUDARABINE PHOSPHATE OGEN .625, ESTROPIPATE OGEN 1.25, ESTROPIPATE OGEN 2.5, ESTROPIPATE OGEN 5, ESTROPIPATE OGESTREL 0.5/50-28, ETHINYL ESTRADIOL OLANZAPINE, OLANZAPINE OLEPTRO, TRAZODONE HYDROCHLORIDE OLUX E, CLOBETASOL PROPIONATE OLUX, CLOBETASOL PROPIONATE OMEPRAZOLE AND SODIUM BICARBONATE, OMEPRAZOLE OMEPRAZOLE MAGNESIUM, OMEPRAZOLE MAGNESIUM (OTC) OMEPRAZOLE, OMEPRAZOLE OMEPRAZOLE, OMEPRAZOLE (OTC) OMNARIS, CICLESONIDE OMNIPAQUE 140, IOHEXOL OMNIPAQUE 180, IOHEXOL OMNIPAQUE 240, IOHEXOL OMNIPAQUE 300, IOHEXOL OMNIPAQUE 350, IOHEXOL OMNIPRED, PREDNISOLONE ACETATE OMNISCAN, GADODIAMIDE OMNITROPE, SOMATROPIN RECOMBINANT ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER, ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE AND SODIUM CHLORIDE IN PLASTIC CONTAINER, ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE ONDANSETRON, ONDANSETRON ONFI, CLOBAZAM ONGLYZA, SAXAGLIPTIN HYDROCHLORIDE ONMEL, ITRACONAZOLE ONSOLIS, FENTANYL CITRATE OPANA ER, OXYMORPHONE HYDROCHLORIDE OPANA, OXYMORPHONE HYDROCHLORIDE OPCON-A, NAPHAZOLINE HYDROCHLORIDE (OTC) OPHTHAINE, PROPARACAINE HYDROCHLORIDE OPHTHETIC, PROPARACAINE HYDROCHLORIDE OPTICROM, CROMOLYN SODIUM OPTIMARK IN PLASTIC CONTAINER, GADOVERSETAMIDE OPTIMARK, GADOVERSETAMIDE OPTIPRANOLOL, METIPRANOLOL HYDROCHLORIDE OPTIRAY 240, IOVERSOL OPTIRAY 300, IOVERSOL OPTIRAY 320, IOVERSOL OPTIRAY 350, IOVERSOL OPTISON, ALBUMIN HUMAN OPTIVAR, AZELASTINE HYDROCHLORIDE ORABASE HCA, HYDROCORTISONE ACETATE ORACEA, DOXYCYCLINE ORAMORPH SR, MORPHINE SULFATE ORAP, PIMOZIDE ORAPRED ODT, PREDNISOLONE SODIUM PHOSPHATE ORAPRED, PREDNISOLONE SODIUM PHOSPHATE ORAQIX, LIDOCAINE ORAVERSE, PHENTOLAMINE MESYLATE ORAVIG, MICONAZOLE ORETIC, HYDROCHLOROTHIAZIDE ORFADIN, NITISINONE ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE, ASPIRIN

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

**

PRODUCT NAME INDEX

O **

A - 40

ORPHENADRINE CITRATE, ORPHENADRINE CITRATE ORSYTHIA, ETHINYL ESTRADIOL ORTHO CYCLEN-28, ETHINYL ESTRADIOL ORTHO EVRA, ETHINYL ESTRADIOL ORTHO TRI-CYCLEN LO, ETHINYL ESTRADIOL ORTHO TRI-CYCLEN, ETHINYL ESTRADIOL ORTHO-CEPT, DESOGESTREL ORTHO-EST, ESTROPIPATE ORTHO-NOVUM 1/35-28, ETHINYL ESTRADIOL ORTHO-NOVUM 7/7/7-28, ETHINYL ESTRADIOL ORVATEN, MIDODRINE HYDROCHLORIDE OSMITROL 10% IN WATER IN PLASTIC CONTAINER, MANNITOL OSMITROL 10% IN WATER, MANNITOL OSMITROL 15% IN WATER IN PLASTIC CONTAINER, MANNITOL OSMITROL 15% IN WATER, MANNITOL OSMITROL 20% IN WATER IN PLASTIC CONTAINER, MANNITOL OSMITROL 20% IN WATER, MANNITOL OSMITROL 5% IN WATER IN PLASTIC CONTAINER, MANNITOL OSMITROL 5% IN WATER, MANNITOL OSMOPREP, SODIUM PHOSPHATE, DIBASIC, ANHYDROUS OTICAIR, HYDROCORTISONE OVCON-35, ETHINYL ESTRADIOL OVCON-50, ETHINYL ESTRADIOL OVIDE, MALATHION OVIDREL, CHORIOGONADOTROPIN ALFA OXACILLIN SODIUM, OXACILLIN SODIUM OXALIPLATIN, OXALIPLATIN OXANDRIN, OXANDROLONE OXANDROLONE, OXANDROLONE OXAPROZIN, OXAPROZIN OXAZEPAM, OXAZEPAM OXCARBAZEPINE, OXCARBAZEPINE OXECTA, OXYCODONE HYDROCHLORIDE OXILAN-300, IOXILAN OXILAN-350, IOXILAN OXISTAT, OXICONAZOLE NITRATE OXSORALEN, METHOXSALEN OXSORALEN-ULTRA, METHOXSALEN OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE OXYCET, ACETAMINOPHEN OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN OXYCODONE AND ASPIRIN, ASPIRIN OXYCODONE HYDROCHLORIDE AND IBUPROFEN, IBUPROFEN OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE OXYCONTIN, OXYCODONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE OXYTOCIN, OXYTOCIN OXYTROL, OXYBUTYNIN OZURDEX, DEXAMETHASONE

**
PACERONE, AMIODARONE HYDROCHLORIDE PACLITAXEL, PACLITAXEL PAMELOR, NORTRIPTYLINE HYDROCHLORIDE PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM PAMINE FORTE, METHSCOPOLAMINE BROMIDE PAMINE, METHSCOPOLAMINE BROMIDE PANCREAZE, LIPASE PANCURONIUM BROMIDE, PANCURONIUM BROMIDE PANDEL, HYDROCORTISONE PROBUTATE PANRETIN, ALITRETINOIN PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM PARAFON FORTE DSC, CHLORZOXAZONE

**

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

**

PRODUCT NAME INDEX

P **

A - 41

PARAGARD T 380A, COPPER PARCOPA, CARBIDOPA PAREMYD, HYDROXYAMPHETAMINE HYDROBROMIDE PARICALCITOL, PARICALCITOL PARLODEL, BROMOCRIPTINE MESYLATE PARNATE, TRANYLCYPROMINE SULFATE PAROMOMYCIN SULFATE, PAROMOMYCIN SULFATE PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE PASER, AMINOSALICYLIC ACID PATADAY, OLOPATADINE HYDROCHLORIDE PATANASE, OLOPATADINE HYDROCHLORIDE PATANOL, OLOPATADINE HYDROCHLORIDE PAXIL CR, PAROXETINE HYDROCHLORIDE PAXIL, PAROXETINE HYDROCHLORIDE PCE, ERYTHROMYCIN PEDIAMYCIN 400, ERYTHROMYCIN ETHYLSUCCINATE PEDIAMYCIN, ERYTHROMYCIN ETHYLSUCCINATE PEDIAPRED, PREDNISOLONE SODIUM PHOSPHATE PEDIATRIC ADVIL, IBUPROFEN (OTC) PEDIOTIC, HYDROCORTISONE PEG 3350 AND ELECTROLYTES, POLYETHYLENE GLYCOL 3350 PEG-3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE, POLYETHYLENE GLYCOL 3350 PEGANONE, ETHOTOIN PENICILLIN G POTASSIUM IN PLASTIC CONTAINER, PENICILLIN G POTASSIUM PENICILLIN G POTASSIUM, PENICILLIN G POTASSIUM PENICILLIN G PROCAINE, PENICILLIN G PROCAINE PENICILLIN G SODIUM, PENICILLIN G SODIUM PENICILLIN V POTASSIUM, PENICILLIN V POTASSIUM PENICILLIN-VK, PENICILLIN V POTASSIUM PENLAC, CICLOPIROX PENNSAID, DICLOFENAC SODIUM PENTAM, PENTAMIDINE ISETHIONATE PENTAMIDINE ISETHIONATE, PENTAMIDINE ISETHIONATE PENTASA, MESALAMINE PENTAZOCINE AND NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE PENTAZOCINE AND NALOXONE HYDROCHLORIDES, NALOXONE HYDROCHLORIDE PENTOLAIR, CYCLOPENTOLATE HYDROCHLORIDE PENTOSTATIN, PENTOSTATIN PENTOXIFYLLINE, PENTOXIFYLLINE PENTOXIL, PENTOXIFYLLINE PEPCID AC (GELTAB), FAMOTIDINE (OTC) PEPCID AC, FAMOTIDINE (OTC) PEPCID COMPLETE, CALCIUM CARBONATE (OTC) PEPCID, FAMOTIDINE PERCOCET, ACETAMINOPHEN PERCODAN, ASPIRIN PERFOROMIST, FORMOTEROL FUMARATE PERIDEX, CHLORHEXIDINE GLUCONATE PERINDOPRIL ERBUMINE, PERINDOPRIL ERBUMINE PERIOCHIP, CHLORHEXIDINE GLUCONATE PERIOGARD, CHLORHEXIDINE GLUCONATE PERIOSTAT, DOXYCYCLINE HYCLATE PERMAPEN, PENICILLIN G BENZATHINE PERMETHRIN, PERMETHRIN PERMETHRIN, PERMETHRIN (OTC) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE, PERPHENAZINE PERSANTINE, DIPYRIDAMOLE PEXEVA, PAROXETINE MESYLATE PFIZERPEN, PENICILLIN G POTASSIUM PHARMASEAL SCRUB CARE, CHLORHEXIDINE GLUCONATE (OTC) PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE PHENELZINE SULFATE, PHENELZINE SULFATE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

**

PRODUCT NAME INDEX

P **

A - 42

PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE PHENTERMINE RESIN COMPLEX, PHENTERMINE RESIN COMPLEX PHENTOLAMINE MESYLATE, PHENTOLAMINE MESYLATE PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE PHENYTEK, PHENYTOIN SODIUM PHENYTOIN SODIUM, PHENYTOIN SODIUM PHENYTOIN, PHENYTOIN PHILITH, ETHINYL ESTRADIOL PHISOHEX, HEXACHLOROPHENE PHOSLO GELCAPS, CALCIUM ACETATE PHOSLYRA, CALCIUM ACETATE PHOSPHOLINE IODIDE, ECHOTHIOPHATE IODIDE PHOTOFRIN, PORFIMER SODIUM PHRENILIN FORTE, ACETAMINOPHEN PHRENILIN WITH CAFFEINE AND CODEINE, ACETAMINOPHEN PHRENILIN, ACETAMINOPHEN PHYSIOLYTE IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE PHYSIOSOL IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE PHYTONADIONE, PHYTONADIONE PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE PILOPINE HS, PILOCARPINE HYDROCHLORIDE PINDOLOL, PINDOLOL PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM PIPERACILLIN, PIPERACILLIN SODIUM PIROXICAM, PIROXICAM PITOCIN, OXYTOCIN PLAN B ONE-STEP, LEVONORGESTREL PLAN B ONE-STEP, LEVONORGESTREL (OTC) PLAN B, LEVONORGESTREL PLAN B, LEVONORGESTREL (OTC) PLAQUENIL, HYDROXYCHLOROQUINE SULFATE PLASMA-LYTE 148 AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE PLASMA-LYTE 56 AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE PLASMA-LYTE 56 IN PLASTIC CONTAINER, MAGNESIUM ACETATE TETRAHYDRATE PLASMA-LYTE A IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE PLASMA-LYTE M AND DEXTROSE 5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE PLASMA-LYTE R IN PLASTIC CONTAINER, CALCIUM CHLORIDE PLAVIX, CLOPIDOGREL BISULFATE PLEGISOL IN PLASTIC CONTAINER, CALCIUM CHLORIDE PLENDIL, FELODIPINE PLETAL, CILOSTAZOL PODOFILOX, PODOFILOX POLOCAINE, MEPIVACAINE HYDROCHLORIDE POLOCAINE-MPF, MEPIVACAINE HYDROCHLORIDE POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES, POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC) POLYMYCIN B SULFATE, POLYMYXIN B SULFATE POLYMYXIN B SULFATE, POLYMYXIN B SULFATE POLY-PRED, NEOMYCIN SULFATE POLY-RX, POLYMYXIN B SULFATE POLYTRIM, POLYMYXIN B SULFATE PONSTEL, MEFENAMIC ACID PORTIA-28, ETHINYL ESTRADIOL POTASSIUM ACETATE IN PLASTIC CONTAINER, POTASSIUM ACETATE POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A
POTASSIUM POTASSIUM POTASSIUM POTASSIUM POTASSIUM DEXTROSE POTASSIUM POTASSIUM DEXTROSE POTASSIUM POTASSIUM POTASSIUM POTASSIUM POTASSIUM POTASSIUM POTASSIUM POTASSIUM POTASSIUM POTASSIUM POTASSIUM POTASSIUM POTASSIUM POTASSIUM POTASSIUM POTASSIUM POTASSIUM POTASSIUM POTASSIUM POTASSIUM POTASSIUM POTASSIUM POTASSIUM POTASSIUM POTASSIUM POTASSIUM POTASSIUM POTASSIUM POTASSIUM POTASSIUM POTASSIUM POTASSIUM POTASSIUM POTASSIUM POTASSIUM POTASSIUM POTASSIUM POTASSIUM POTASSIUM POTASSIUM POTASSIUM POTASSIUM POTASSIUM POTASSIUM POTASSIUM POTASSIUM POTASSIUM POTASSIUM POTASSIUM POTASSIUM POTASSIUM CHLORIDE POTASSIUM POTASSIUM POTASSIUM CHLORIDE CHLORIDE CHLORIDE CHLORIDE CHLORIDE 0.037% 0.037% 0.037% 0.075% 0.075% IN IN IN IN IN DEXTROSE DEXTROSE DEXTROSE DEXTROSE DEXTROSE

**

PRODUCT NAME INDEX

P **

A - 43

5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE CHLORIDE 0.075% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, CHLORIDE CHLORIDE CHLORIDE CHLORIDE CHLORIDE CHLORIDE CHLORIDE CHLORIDE CHLORIDE CHLORIDE CHLORIDE CHLORIDE CHLORIDE CHLORIDE CHLORIDE CHLORIDE CHLORIDE CHLORIDE CHLORIDE CHLORIDE CHLORIDE CHLORIDE CHLORIDE CHLORIDE CHLORIDE CHLORIDE CHLORIDE CHLORIDE CHLORIDE CHLORIDE CHLORIDE CHLORIDE CHLORIDE CHLORIDE CHLORIDE CHLORIDE CHLORIDE CHLORIDE CHLORIDE CHLORIDE CHLORIDE CHLORIDE CHLORIDE CHLORIDE CHLORIDE CHLORIDE CHLORIDE CHLORIDE CHLORIDE CHLORIDE CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE 0.11% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE 0.15% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE 0.15% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE 0.22% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE 0.224% IN SODIUM CHLORIDE 0.9%, POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE 0.3% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM

CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER, DEXTROSE CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

**

PRODUCT NAME INDEX

P **

A - 44

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE IN PLASTIC CONTAINER, POTASSIUM CHLORIDE POTASSIUM CHLORIDE, POTASSIUM CHLORIDE POTASSIUM CITRATE, POTASSIUM CITRATE POTIGA, EZOGABINE POVIDONE IODINE, POVIDONE-IODINE (OTC) PRADAXA, DABIGATRAN ETEXILATE MESYLATE PRALIDOXIME CHLORIDE, PRALIDOXIME CHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE PRAMOSONE, HYDROCORTISONE ACETATE PRANDIMET, METFORMIN HYDROCHLORIDE PRANDIN, REPAGLINIDE PRAVACHOL, PRAVASTATIN SODIUM PRAVASTATIN SODIUM, PRAVASTATIN SODIUM PRAZOSIN HYDROCHLORIDE, PRAZOSIN HYDROCHLORIDE PRECEDEX, DEXMEDETOMIDINE HYDROCHLORIDE PRECOSE, ACARBOSE PRED FORTE, PREDNISOLONE ACETATE PRED MILD, PREDNISOLONE ACETATE PRED-G, GENTAMICIN SULFATE PREDNICARBATE, PREDNICARBATE PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE, PREDNISOLONE PREDNISONE INTENSOL, PREDNISONE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

**

PRODUCT NAME INDEX

P **

A - 45

PREDNISONE, PREDNISONE PREFEST, ESTRADIOL PREGNYL, GONADOTROPIN, CHORIONIC PRELONE, PREDNISOLONE PREMARIN, ESTROGENS, CONJUGATED PREMASOL 10% IN PLASTIC CONTAINER, AMINO ACIDS PREMASOL 6% IN PLASTIC CONTAINER, AMINO ACIDS PREMPHASE 14/14, ESTROGENS, CONJUGATED PREMPRO, ESTROGENS, CONJUGATED PRE-OP II, HEXACHLOROPHENE PRE-OP, HEXACHLOROPHENE PRE-PEN, BENZYLPENICILLOYL POLYLYSINE PREPIDIL, DINOPROSTONE PREVACID 24 HR, LANSOPRAZOLE (OTC) PREVACID, LANSOPRAZOLE PREVALITE, CHOLESTYRAMINE PREVIFEM, ETHINYL ESTRADIOL PREVPAC, AMOXICILLIN PREZISTA, DARUNAVIR ETHANOLATE PRIALT, ZICONOTIDE ACETATE PRIFTIN, RIFAPENTINE PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE, EPINEPHRINE BITARTRATE PRILOCAINE HYDROCHLORIDE, PRILOCAINE HYDROCHLORIDE PRILOSEC OTC, OMEPRAZOLE MAGNESIUM (OTC) PRILOSEC, OMEPRAZOLE PRILOSEC, OMEPRAZOLE MAGNESIUM PRIMAQUINE, PRIMAQUINE PHOSPHATE PRIMAXIN, CILASTATIN SODIUM PRIMIDONE, PRIMIDONE PRIMSOL, TRIMETHOPRIM HYDROCHLORIDE PRINIVIL, LISINOPRIL PRINZIDE, HYDROCHLOROTHIAZIDE PRISMASOL B22GK 2/0 IN PLASTIC CONTAINER, CALCIUM CHLORIDE PRISMASOL B22GK 4/0 IN PLASTIC CONTAINER, CALCIUM CHLORIDE PRISMASOL B22GK 4/2.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE PRISMASOL BGK 0/2.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE PRISMASOL BGK 2/0 IN PLASTIC CONTAINER, CALCIUM CHLORIDE PRISMASOL BGK 2/3.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE PRISMASOL BGK 4/0/1.2 IN PLASTIC CONTAINER, CALCIUM CHLORIDE PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE PRISMASOL BK 0/0/1.2 IN PLASTIC CONTAINER, CALCIUM CHLORIDE PRISMASOL BK 0/3.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE PRISTIQ, DESVENLAFAXINE SUCCINATE PROAIR HFA, ALBUTEROL SULFATE PROAMATINE, MIDODRINE HYDROCHLORIDE PROBALAN, PROBENECID PROBENECID AND COLCHICINE, COLCHICINE PROBENECID, PROBENECID PROCAINAMIDE HYDROCHLORIDE, PROCAINAMIDE HYDROCHLORIDE PROCALAMINE, AMINO ACIDS PROCARDIA XL, NIFEDIPINE PROCARDIA, NIFEDIPINE PROCHLORPERAZINE EDISYLATE, PROCHLORPERAZINE EDISYLATE PROCHLORPERAZINE MALEATE, PROCHLORPERAZINE MALEATE PROCHLORPERAZINE, PROCHLORPERAZINE PROCOMP, PROCHLORPERAZINE MALEATE PROCTOFOAM HC, HYDROCORTISONE ACETATE PROFEN, IBUPROFEN (OTC) PROFERDEX, IRON DEXTRAN PROGESTERONE, PROGESTERONE PROGLYCEM, DIAZOXIDE PROGRAF, TACROLIMUS PROHANCE MULTIPACK, GADOTERIDOL

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

**

PRODUCT NAME INDEX

P **

A - 46

PROHANCE, GADOTERIDOL PROMACTA, ELTROMBOPAG OLAMINE PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE, CODEINE PHOSPHATE PROMETH VC PLAIN, PHENYLEPHRINE HYDROCHLORIDE PROMETH VC W/ CODEINE, CODEINE PHOSPHATE PROMETH W/ DEXTROMETHORPHAN, DEXTROMETHORPHAN HYDROBROMIDE PROMETHAZINE DM, DEXTROMETHORPHAN HYDROBROMIDE PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE, DEXTROMETHORPHAN HYDROBROMIDE PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE PROMETHAZINE PLAIN, PROMETHAZINE HYDROCHLORIDE PROMETHAZINE W/ DEXTROMETHORPHAN, DEXTROMETHORPHAN HYDROBROMIDE PROMETHAZINE WITH CODEINE, CODEINE PHOSPHATE PROMETHEGAN, PROMETHAZINE HYDROCHLORIDE PROMETRIUM, PROGESTERONE PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE PROPANTHELINE BROMIDE, PROPANTHELINE BROMIDE PROPARACAINE HYDROCHLORIDE, PROPARACAINE HYDROCHLORIDE PROPECIA, FINASTERIDE PROPINE, DIPIVEFRIN HYDROCHLORIDE PROPOFOL, PROPOFOL PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE PROPYLTHIOURACIL, PROPYLTHIOURACIL PROSCAR, FINASTERIDE PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER, AMINO ACIDS PROSTIN E2, DINOPROSTONE PROSTIN VR PEDIATRIC, ALPROSTADIL PROTAMINE SULFATE, PROTAMINE SULFATE PROTONIX IV, PANTOPRAZOLE SODIUM PROTONIX, PANTOPRAZOLE SODIUM PROTOPAM CHLORIDE, PRALIDOXIME CHLORIDE PROTOPIC, TACROLIMUS PROTRIPTYLINE HYDROCHLORIDE, PROTRIPTYLINE HYDROCHLORIDE PROVENTIL-HFA, ALBUTEROL SULFATE PROVERA, MEDROXYPROGESTERONE ACETATE PROVIGIL, MODAFINIL PROVOCHOLINE, METHACHOLINE CHLORIDE PROZAC WEEKLY, FLUOXETINE HYDROCHLORIDE PROZAC, FLUOXETINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (OTC) PULMICORT FLEXHALER, BUDESONIDE PULMICORT RESPULES, BUDESONIDE PULMICORT, BUDESONIDE PULMOLITE, TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT PURINETHOL, MERCAPTOPURINE PUR-WASH, PURIFIED WATER (OTC) PYLERA, BISMUTH SUBCITRATE POTASSIUM PYRAZINAMIDE, PYRAZINAMIDE PYRIDOSTIGMINE BROMIDE, PYRIDOSTIGMINE BROMIDE PYRIDOXINE HYDROCHLORIDE, PYRIDOXINE HYDROCHLORIDE PYTEST KIT, UREA, C-14 PYTEST, UREA, C-14

**

**

QUADRAMET, SAMARIUM SM-153 LEXIDRONAM PENTASODIUM QUALAQUIN, QUININE SULFATE QUASENSE, ETHINYL ESTRADIOL QUELICIN PRESERVATIVE FREE, SUCCINYLCHOLINE CHLORIDE QUELICIN, SUCCINYLCHOLINE CHLORIDE QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A
QUINARETIC, HYDROCHLOROTHIAZIDE QUINIDINE GLUCONATE, QUINIDINE GLUCONATE QUINIDINE SULFATE, QUINIDINE SULFATE QUIXIN, LEVOFLOXACIN QUTENZA, CAPSAICIN QVAR 40, BECLOMETHASONE DIPROPIONATE QVAR 80, BECLOMETHASONE DIPROPIONATE

**

PRODUCT NAME INDEX

Q **

A - 47

**

**

RADIOGARDASE (PRUSSIAN BLUE), FERRIC HEXACYANOFERRATE(II) RAMIPRIL, RAMIPRIL RANEXA, RANOLAZINE RANICLOR, CEFACLOR RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC) RAPAFLO, SILODOSIN RAPAMUNE, SIROLIMUS RAZADYNE ER, GALANTAMINE HYDROBROMIDE RAZADYNE, GALANTAMINE HYDROBROMIDE REBETOL, RIBAVIRIN RECLAST, ZOLEDRONIC ACID RECTIV, NITROGLYCERIN REFLUDAN, LEPIRUDIN RECOMBINANT REGITINE, PHENTOLAMINE MESYLATE REGLAN, METOCLOPRAMIDE HYDROCHLORIDE REGONOL, PYRIDOSTIGMINE BROMIDE RELENZA, ZANAMIVIR RELISTOR, METHYLNALTREXONE BROMIDE RELPAX, ELETRIPTAN HYDROBROMIDE REMERON SOLTAB, MIRTAZAPINE REMERON, MIRTAZAPINE REMODULIN, TREPROSTINIL SODIUM RENACIDIN, CITRIC ACID RENAGEL, SEVELAMER HYDROCHLORIDE RENAMIN W/O ELECTROLYTES, AMINO ACIDS RENOGRAFIN-76, DIATRIZOATE MEGLUMINE RENOVA, TRETINOIN RENVELA, SEVELAMER CARBONATE REPREXAIN, HYDROCODONE BITARTRATE REPRONEX, LUTEINIZING HORMONE REQUIP XL, ROPINIROLE HYDROCHLORIDE REQUIP, ROPINIROLE HYDROCHLORIDE RESCRIPTOR, DELAVIRDINE MESYLATE RESECTISOL IN PLASTIC CONTAINER, MANNITOL RESERPINE, RESERPINE RESTASIS, CYCLOSPORINE RESTORIL, TEMAZEPAM RETIN-A MICRO, TRETINOIN RETIN-A, TRETINOIN RETISERT, FLUOCINOLONE ACETONIDE RETROVIR, ZIDOVUDINE REVATIO, SILDENAFIL CITRATE REVIA, NALTREXONE HYDROCHLORIDE REVLIMID, LENALIDOMIDE REYATAZ, ATAZANAVIR SULFATE REZIRA, HYDROCODONE BITARTRATE R-GENE 10, ARGININE HYDROCHLORIDE RHINOCORT, BUDESONIDE RIBASPHERE, RIBAVIRIN RIBAVARIN, RIBAVIRIN RIBAVIRIN, RIBAVIRIN RID MOUSSE, PIPERONYL BUTOXIDE (OTC) RIDAURA, AURANOFIN

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

**

PRODUCT NAME INDEX

R **

A - 48

RIFADIN, RIFAMPIN RIFAMATE, ISONIAZID RIFAMPIN AND ISONIAZID, ISONIAZID RIFAMPIN, RIFAMPIN RIFATER, ISONIAZID RILUTEK, RILUZOLE RILUZOLE, RILUZOLE RIMANTADINE HYDROCHLORIDE, RIMANTADINE HYDROCHLORIDE RIMSO-50, DIMETHYL SULFOXIDE RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE RIOMET, METFORMIN HYDROCHLORIDE RISEDRONATE SODIUM, RISEDRONATE SODIUM RISPERDAL CONSTA, RISPERIDONE RISPERDAL, RISPERIDONE RISPERIDONE, RISPERIDONE RITALIN LA, METHYLPHENIDATE HYDROCHLORIDE RITALIN, METHYLPHENIDATE HYDROCHLORIDE RITALIN-SR, METHYLPHENIDATE HYDROCHLORIDE RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE ROBAXIN, METHOCARBAMOL ROBAXIN-750, METHOCARBAMOL ROBINUL FORTE, GLYCOPYRROLATE ROBINUL, GLYCOPYRROLATE ROCALTROL, CALCITRIOL ROCEPHIN, CEFTRIAXONE SODIUM ROCURONIUM BROMIDE, ROCURONIUM BROMIDE ROGAINE (FOR MEN), MINOXIDIL (OTC) ROGAINE (FOR WOMEN), MINOXIDIL (OTC) ROGAINE EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC) ROMAZICON, FLUMAZENIL ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE ROWASA, MESALAMINE ROXICET 5/500, ACETAMINOPHEN ROXICET, ACETAMINOPHEN ROXICODONE, OXYCODONE HYDROCHLORIDE ROXILOX, ACETAMINOPHEN ROZEREM, RAMELTEON RYTHMOL SR, PROPAFENONE HYDROCHLORIDE RYTHMOL, PROPAFENONE HYDROCHLORIDE RYZOLT, TRAMADOL HYDROCHLORIDE

**
SABRIL, VIGABATRIN SAFYRAL, DROSPIRENONE SAIZEN, SOMATROPIN RECOMBINANT SALAGEN, PILOCARPINE HYDROCHLORIDE SALONPAS, MENTHOL (OTC) SALURON, HYDROFLUMETHIAZIDE SAMSCA, TOLVAPTAN SANCTURA XR, TROSPIUM CHLORIDE SANCTURA, TROSPIUM CHLORIDE SANCUSO, GRANISETRON SANDIMMUNE, CYCLOSPORINE SANDOSTATIN LAR, OCTREOTIDE ACETATE SANDOSTATIN, OCTREOTIDE ACETATE SAPHRIS, ASENAPINE MALEATE SARAFEM, FLUOXETINE HYDROCHLORIDE SAVELLA, MILNACIPRAN HYDROCHLORIDE SCANDONEST L, LEVONORDEFRIN SCANDONEST PLAIN, MEPIVACAINE HYDROCHLORIDE SCANLUX-300, IOPAMIDOL SCANLUX-370, IOPAMIDOL SCLEROSOL, TALC

**

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

**

PRODUCT NAME INDEX

S **

A - 49

SEASONALE, ETHINYL ESTRADIOL SEASONIQUE, ETHINYL ESTRADIOL SECONAL SODIUM, SECOBARBITAL SODIUM SECTRAL, ACEBUTOLOL HYDROCHLORIDE SELEGILINE HYDROCHLORIDE, SELEGILINE HYDROCHLORIDE SELENIUM SULFIDE, SELENIUM SULFIDE SELSUN, SELENIUM SULFIDE SELZENTRY, MARAVIROC SEMPREX-D, ACRIVASTINE SENSIPAR, CINACALCET HYDROCHLORIDE SENSORCAINE, BUPIVACAINE HYDROCHLORIDE SEPTOCAINE, ARTICAINE HYDROCHLORIDE SEPTRA DS, SULFAMETHOXAZOLE SEPTRA, SULFAMETHOXAZOLE SEREVENT, SALMETEROL XINAFOATE SEROMYCIN, CYCLOSERINE SEROPHENE, CLOMIPHENE CITRATE SEROQUEL XR, QUETIAPINE FUMARATE SEROQUEL, QUETIAPINE FUMARATE SEROSTIM, SOMATROPIN RECOMBINANT SERPALAN, RESERPINE SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE SEVOFLURANE, SEVOFLURANE SFROWASA, MESALAMINE SHADE UVAGUARD, AVOBENZONE (OTC) SILENOR, DOXEPIN HYDROCHLORIDE SILVADENE, SILVER SULFADIAZINE SIMCOR, NIACIN SIMVASTATIN, SIMVASTATIN SINE-AID IB, IBUPROFEN (OTC) SINEMET CR, CARBIDOPA SINEMET, CARBIDOPA SINGULAIR, MONTELUKAST SODIUM SINOGRAFIN, DIATRIZOATE MEGLUMINE SKELAXIN, METAXALONE SKELID, TILUDRONATE DISODIUM SODIUM ACETATE IN PLASTIC CONTAINER, SODIUM ACETATE ANHYDROUS SODIUM BICARBONATE, SODIUM BICARBONATE SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, SODIUM CHLORIDE SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER, SODIUM CHLORIDE SODIUM CHLORIDE 3% IN PLASTIC CONTAINER, SODIUM CHLORIDE SODIUM CHLORIDE 5% IN PLASTIC CONTAINER, SODIUM CHLORIDE SODIUM CHLORIDE IN PLASTIC CONTAINER, SODIUM CHLORIDE SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE, SODIUM FERRIC GLUCONATE COMPLEX SODIUM IODIDE I 123, SODIUM IODIDE I-123 SODIUM IODIDE I 131, SODIUM IODIDE I-131 SODIUM IODIDE I-131, SODIUM IODIDE I-131 SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER, SODIUM LACTATE SODIUM LACTATE 1/6 MOLAR IN PLASTIC CONTAINER, SODIUM LACTATE SODIUM LACTATE IN PLASTIC CONTAINER, SODIUM LACTATE SODIUM PHENYLBUTYRATE, SODIUM PHENYLBUTYRATE SODIUM PHOSPHATES IN PLASTIC CONTAINER, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE SODIUM POLYSTYRENE SULFONATE, SODIUM POLYSTYRENE SULFONATE SOJOURN, SEVOFLURANE SOLAGE, MEQUINOL SOLARAZE, DICLOFENAC SODIUM SOLODYN, MINOCYCLINE HYDROCHLORIDE SOLU-CORTEF, HYDROCORTISONE SODIUM SUCCINATE SOLU-MEDROL, METHYLPREDNISOLONE SODIUM SUCCINATE SOMA COMPOUND W/ CODEINE, ASPIRIN SOMA COMPOUND, ASPIRIN SOMA, CARISOPRODOL

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

**

PRODUCT NAME INDEX

S **

A - 50

SOMATULINE DEPOT, LANREOTIDE ACETATE SOMAVERT, PEGVISOMANT SONATA, ZALEPLON SORBITOL 3% IN PLASTIC CONTAINER, SORBITOL SORBITOL 3.3% IN PLASTIC CONTAINER, SORBITOL SORBITOL-MANNITOL IN PLASTIC CONTAINER, MANNITOL SORIATANE, ACITRETIN SORILUX, CALCIPOTRIENE SORINE, SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE SOTRADECOL, SODIUM TETRADECYL SULFATE SOTRET, ISOTRETINOIN SPECTRACEF, CEFDITOREN PIVOXIL SPIRIVA, TIOTROPIUM BROMIDE MONOHYDRATE SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE SPIRONOLACTONE, SPIRONOLACTONE SPORANOX, ITRACONAZOLE SPRINTEC, ETHINYL ESTRADIOL SPRIX, KETOROLAC TROMETHAMINE SPRYCEL, DASATINIB SPS, SODIUM POLYSTYRENE SULFONATE SSD AF, SILVER SULFADIAZINE SSD, SILVER SULFADIAZINE STADOL PRESERVATIVE FREE, BUTORPHANOL TARTRATE STADOL, BUTORPHANOL TARTRATE STALEVO 100, CARBIDOPA STALEVO 125, CARBIDOPA STALEVO 150, CARBIDOPA STALEVO 200, CARBIDOPA STALEVO 50, CARBIDOPA STALEVO 75, CARBIDOPA STARLIX, NATEGLINIDE STAVUDINE, STAVUDINE STAVZOR, VALPROIC ACID STAXYN, VARDENAFIL HYDROCHLORIDE STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION STERILE WATER IN PLASTIC CONTAINER, STERILE WATER FOR IRRIGATION STERILE WATER, STERILE WATER FOR IRRIGATION STIE-CORT, HYDROCORTISONE STIMATE (NEEDS NO REFRIGERATION), DESMOPRESSIN ACETATE STRATTERA, ATOMOXETINE HYDROCHLORIDE STREPTOMYCIN SULFATE, STREPTOMYCIN SULFATE STRIANT, TESTOSTERONE STROMECTOL, IVERMECTIN STRONTIUM CHLORIDE SR-89, STRONTIUM CHLORIDE SR-89 SUBLIMAZE PRESERVATIVE FREE, FENTANYL CITRATE SUBOXONE, BUPRENORPHINE SUBOXONE, BUPRENORPHINE HYDROCHLORIDE SUBUTEX, BUPRENORPHINE HYDROCHLORIDE SUCRAID, SACROSIDASE SUCRALFATE, SUCRALFATE SUDAFED 12 HOUR, PSEUDOEPHEDRINE HYDROCHLORIDE (OTC) SUDAFED 24 HOUR, PSEUDOEPHEDRINE HYDROCHLORIDE (OTC) SUFENTA PRESERVATIVE FREE, SUFENTANIL CITRATE SUFENTANIL CITRATE, SUFENTANIL CITRATE SULAR, NISOLDIPINE SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM SULFADIAZINE, SULFADIAZINE SULFAMETHOPRIM, SULFAMETHOXAZOLE SULFAMETHOPRIM-DS, SULFAMETHOXAZOLE SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH, SULFAMETHOXAZOLE SULFAMETHOXAZOLE AND TRIMETHOPRIM SINGLE STRENGTH, SULFAMETHOXAZOLE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

**

PRODUCT NAME INDEX

S **

A - 51

SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE SULFAMYLON, MAFENIDE ACETATE SULFASALAZINE, SULFASALAZINE SULFATRIM PEDIATRIC, SULFAMETHOXAZOLE SULINDAC, SULINDAC SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE SUMAVEL DOSEPRO, SUMATRIPTAN SUCCINATE SUPPRELIN LA, HISTRELIN ACETATE SUPRANE, DESFLURANE SUPRAX, CEFIXIME SUPRENZA, PHENTERMINE HYDROCHLORIDE SUPREP BOWEL PREP KIT, MAGNESIUM SULFATE ANHYDROUS SURMONTIL, TRIMIPRAMINE MALEATE SURVANTA, BERACTANT SUSTIVA, EFAVIRENZ SUTENT, SUNITINIB MALATE SYEDA, DROSPIRENONE SYMBICORT, BUDESONIDE SYMBYAX, FLUOXETINE HYDROCHLORIDE SYMLIN, PRAMLINTIDE ACETATE SYNACORT, HYDROCORTISONE SYNALAR, FLUOCINOLONE ACETONIDE SYNALGOS-DC, ASPIRIN SYNAREL, NAFARELIN ACETATE SYNERA, LIDOCAINE SYNERCID, DALFOPRISTIN SYNTHETIC CONJUGATED ESTROGENS A, ESTROGENS, CONJUGATED SYNTHETIC A SYNTHROID, LEVOTHYROXINE SODIUM SYPRINE, TRIENTINE HYDROCHLORIDE

**

**

TAB-PROFEN, IBUPROFEN (OTC) TACLONEX SCALP, BETAMETHASONE DIPROPIONATE TACLONEX, BETAMETHASONE DIPROPIONATE TACROLIMUS, TACROLIMUS TAGAMET HB, CIMETIDINE (OTC) TAGAMET, CIMETIDINE TALC, TALC TALWIN, PENTAZOCINE LACTATE TAMBOCOR, FLECAINIDE ACETATE TAMIFLU, OSELTAMIVIR PHOSPHATE TAMOXIFEN CITRATE, TAMOXIFEN CITRATE TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE TAPAZOLE, METHIMAZOLE TARCEVA, ERLOTINIB HYDROCHLORIDE TARGRETIN, BEXAROTENE TARKA, TRANDOLAPRIL TASIGNA, NILOTINIB HYDROCHLORIDE MONOHYDRATE TASMAR, TOLCAPONE TAVIST ALLERGY/SINUS/HEADACHE, ACETAMINOPHEN (OTC) TAVIST-1, CLEMASTINE FUMARATE (OTC) TAXOTERE, DOCETAXEL TAZICEF, CEFTAZIDIME TAZORAC, TAZAROTENE TAZTIA XT, DILTIAZEM HYDROCHLORIDE TECHNELITE, TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR TECHNESCAN MAG3, TECHNETIUM TC-99M MERTIATIDE KIT TECHNESCAN PYP KIT, TECHNETIUM TC-99M PYROPHOSPHATE KIT TECHNESCAN, TECHNETIUM TC-99M OXIDRONATE KIT TECHNETIUM TC 99M ALBUMIN AGGREGATED KIT, TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT TECHNETIUM TC 99M SESTAMIBI, TECHNETIUM TC-99M SESTAMIBI KIT TECHNETIUM TC-99 SESTAMIBI, TECHNETIUM TC-99M SESTAMIBI KIT TECHNETIUM TC-99M MEBROFENIN, TECHNETIUM TC-99M MEBROFENIN KIT

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

**

PRODUCT NAME INDEX

T **

A - 52

TEFLARO, CEFTAROLINE FOSAMIL TEGRETOL, CARBAMAZEPINE TEGRETOL-XR, CARBAMAZEPINE TEKAMLO, ALISKIREN HEMIFUMARATE TEKTURNA HCT, ALISKIREN HEMIFUMARATE TEKTURNA, ALISKIREN HEMIFUMARATE TEMAZEPAM, TEMAZEPAM TEMODAR, TEMOZOLOMIDE TEMOVATE E, CLOBETASOL PROPIONATE TEMOVATE, CLOBETASOL PROPIONATE TEMOZOLOMIDE, TEMOZOLOMIDE TENEX, GUANFACINE HYDROCHLORIDE TENORETIC 100, ATENOLOL TENORETIC 50, ATENOLOL TENORMIN, ATENOLOL TENSILON PRESERVATIVE FREE, EDROPHONIUM CHLORIDE TENSILON, EDROPHONIUM CHLORIDE TENUATE DOSPAN, DIETHYLPROPION HYDROCHLORIDE TENUATE, DIETHYLPROPION HYDROCHLORIDE TERAZOL 3, TERCONAZOLE TERAZOL 7, TERCONAZOLE TERAZOSIN HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE (OTC) TERBUTALINE SULFATE, TERBUTALINE SULFATE TERCONAZOLE, TERCONAZOLE TERIL, CARBAMAZEPINE TERRAMYCIN W/ POLYMYXIN B SULFATE, OXYTETRACYCLINE HYDROCHLORIDE TESSALON, BENZONATATE TESTIM, TESTOSTERONE TESTOPEL, TESTOSTERONE TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE TESTOSTERONE ENANTHATE, TESTOSTERONE ENANTHATE TESTRED, METHYLTESTOSTERONE TETRACYCLINE HYDROCHLORIDE, TETRACYCLINE HYDROCHLORIDE TEVETEN HCT, EPROSARTAN MESYLATE TEVETEN, EPROSARTAN MESYLATE TEV-TROPIN, SOMATROPIN RECOMBINANT TEXACORT, HYDROCORTISONE THALITONE, CHLORTHALIDONE THALLOUS CHLORIDE TL 201, THALLOUS CHLORIDE TL-201 THALOMID, THALIDOMIDE THAM, TROMETHAMINE THEO-24, THEOPHYLLINE THEOCHRON, THEOPHYLLINE THEOLAIR, THEOPHYLLINE THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE THEOPHYLLINE 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE THEOPHYLLINE, THEOPHYLLINE THERMAZENE, SILVER SULFADIAZINE THEROXIDIL, MINOXIDIL (OTC) THIAMINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE THIOGUANINE, THIOGUANINE THIORIDAZINE HYDROCHLORIDE, THIORIDAZINE HYDROCHLORIDE THIOTEPA, THIOTEPA THIOTHIXENE, THIOTHIXENE THRIVE, NICOTINE POLACRILEX (OTC) THYROGEN, THYROTROPIN ALFA THYROLAR-0.25, LIOTHYRONINE SODIUM

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

**

PRODUCT NAME INDEX

T **

A - 53

THYROLAR-0.5, LIOTHYRONINE SODIUM THYROLAR-1, LIOTHYRONINE SODIUM THYROLAR-2, LIOTHYRONINE SODIUM THYROLAR-3, LIOTHYRONINE SODIUM THYROSAFE, POTASSIUM IODIDE (OTC) THYROSHIELD, POTASSIUM IODIDE (OTC) TIAGABINE HYDROCHLORIDE, TIAGABINE HYDROCHLORIDE TIAZAC, DILTIAZEM HYDROCHLORIDE TICLOPIDINE HYDROCHLORIDE, TICLOPIDINE HYDROCHLORIDE TIGAN, TRIMETHOBENZAMIDE HYDROCHLORIDE TIKOSYN, DOFETILIDE TIMENTIN IN PLASTIC CONTAINER, CLAVULANATE POTASSIUM TIMENTIN, CLAVULANATE POTASSIUM TIMOLOL MALEATE, TIMOLOL MALEATE TIMOPTIC IN OCUDOSE, TIMOLOL MALEATE TIMOPTIC, TIMOLOL MALEATE TIMOPTIC-XE, TIMOLOL MALEATE TINDAMAX, TINIDAZOLE TIOCONAZOLE, TIOCONAZOLE (OTC) TIOPRONIN, TIOPRONIN TIROSINT, LEVOTHYROXINE SODIUM TIS-U-SOL IN PLASTIC CONTAINER, MAGNESIUM SULFATE TIS-U-SOL, MAGNESIUM SULFATE TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE TOBI, TOBRAMYCIN TOBRADEX ST, DEXAMETHASONE TOBRADEX, DEXAMETHASONE TOBRAMYCIN AND DEXAMETHASONE, DEXAMETHASONE TOBRAMYCIN SULFATE (PHARMACY BULK), TOBRAMYCIN SULFATE TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, TOBRAMYCIN SULFATE TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE TOBRAMYCIN, TOBRAMYCIN TOBREX, TOBRAMYCIN TODAY, NONOXYNOL-9 (OTC) TOFRANIL, IMIPRAMINE HYDROCHLORIDE TOFRANIL-PM, IMIPRAMINE PAMOATE TOLAZAMIDE, TOLAZAMIDE TOLBUTAMIDE, TOLBUTAMIDE TOLMETIN SODIUM, TOLMETIN SODIUM TOPAMAX, TOPIRAMATE TOPICORT LP, DESOXIMETASONE TOPICORT, DESOXIMETASONE TOPIRAMATE, TOPIRAMATE TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE TOPOTECAN, TOPOTECAN HYDROCHLORIDE TOPROL-XL, METOPROLOL SUCCINATE TORISEL, TEMSIROLIMUS TORSEMIDE, TORSEMIDE TOTECT, DEXRAZOXANE HYDROCHLORIDE TOVIAZ, FESOTERODINE FUMARATE TPN ELECTROLYTES IN PLASTIC CONTAINER, CALCIUM CHLORIDE TRACLEER, BOSENTAN TRADJENTA, LINAGLIPTIN TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE TRANDATE, LABETALOL HYDROCHLORIDE TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE, TRANDOLAPRIL TRANDOLAPRIL, TRANDOLAPRIL TRANEXAMIC ACID, TRANEXAMIC ACID TRANSDERM SCOP, SCOPOLAMINE TRANXENE, CLORAZEPATE DIPOTASSIUM TRANYLCYPROMINE SULFATE, TRANYLCYPROMINE SULFATE TRASYLOL, APROTININ

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

**

PRODUCT NAME INDEX

T **

A - 54

TRAVASOL 10% IN PLASTIC CONTAINER, AMINO ACIDS TRAVASOL 10% W/O ELECTROLYTES, AMINO ACIDS TRAVASOL 3.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER, AMINO ACIDS TRAVASOL 3.5% W/ ELECTROLYTES, AMINO ACIDS TRAVASOL 5.5% IN PLASTIC CONTAINER, AMINO ACIDS TRAVASOL 5.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER, AMINO ACIDS TRAVASOL 5.5% W/ ELECTROLYTES, AMINO ACIDS TRAVASOL 5.5% W/O ELECTROLYTES, AMINO ACIDS TRAVASOL 8.5% IN PLASTIC CONTAINER, AMINO ACIDS TRAVASOL 8.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER, AMINO ACIDS TRAVASOL 8.5% W/ ELECTROLYTES, AMINO ACIDS TRAVASOL 8.5% W/O ELECTROLYTES, AMINO ACIDS TRAVATAN Z, TRAVOPROST TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE TREANDA, BENDAMUSTINE HYDROCHLORIDE TRECATOR, ETHIONAMIDE TRELSTAR, TRIPTORELIN PAMOATE TRENTAL, PENTOXIFYLLINE TRETINOIN, TRETINOIN TREXALL, METHOTREXATE SODIUM TREXIMET, NAPROXEN SODIUM TRI LO SPRINTEC, ETHINYL ESTRADIOL TRIACET, TRIAMCINOLONE ACETONIDE TRIACIN-C, CODEINE PHOSPHATE TRIAMCINOLONE ACETONIDE IN ABSORBASE, TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE TRIAZOLAM, TRIAZOLAM TRIBENZOR, AMLODIPINE BESYLATE TRICOR, FENOFIBRATE TRIDERM, TRIAMCINOLONE ACETONIDE TRIDIONE, TRIMETHADIONE TRIESENCE, TRIAMCINOLONE ACETONIDE TRIFLUOPERAZINE HYDROCHLORIDE, TRIFLUOPERAZINE HYDROCHLORIDE TRIFLURIDINE, TRIFLURIDINE TRIGLIDE, FENOFIBRATE TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE TRI-LEGEST 21, ETHINYL ESTRADIOL TRI-LEGEST FE, ETHINYL ESTRADIOL TRILEPTAL, OXCARBAZEPINE TRILIPIX, CHOLINE FENOFIBRATE TRI-LUMA, FLUOCINOLONE ACETONIDE TRILYTE, POLYETHYLENE GLYCOL 3350 TRIMETHOBENZAMIDE HYDROCHLORIDE PRESERVATIVE FREE, TRIMETHOBENZAMIDE HYDROCHLORIDE TRIMETHOBENZAMIDE HYDROCHLORIDE, TRIMETHOBENZAMIDE HYDROCHLORIDE TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE, POLYMYXIN B SULFATE TRIMETHOPRIM, TRIMETHOPRIM TRIMIPRAMINE MALEATE, TRIMIPRAMINE MALEATE TRI-NORINYL 28-DAY, ETHINYL ESTRADIOL TRIOSTAT, LIOTHYRONINE SODIUM TRI-PREVIFEM, ETHINYL ESTRADIOL TRISENOX, ARSENIC TRIOXIDE TRI-SPRINTEC, ETHINYL ESTRADIOL TRIVAGIZOLE 3, CLOTRIMAZOLE (OTC) TRIVARIS, TRIAMCINOLONE ACETONIDE TRIVORA-28, ETHINYL ESTRADIOL TRIZIVIR, ABACAVIR SULFATE TROPHAMINE 10%, AMINO ACIDS TROPHAMINE, AMINO ACIDS TROPICACYL, TROPICAMIDE TROPICAMIDE, TROPICAMIDE TROSPIUM CHLORIDE, TROSPIUM CHLORIDE TRUSOPT, DORZOLAMIDE HYDROCHLORIDE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

**

PRODUCT NAME INDEX

T **

A - 55

TRUVADA, EMTRICITABINE TUSSICAPS, CHLORPHENIRAMINE POLISTIREX TUSSIGON, HOMATROPINE METHYLBROMIDE TUSSIONEX PENNKINETIC, CHLORPHENIRAMINE POLISTIREX TWINJECT 0.15, EPINEPHRINE TWINJECT 0.3, EPINEPHRINE TWYNSTA, AMLODIPINE BESYLATE TYGACIL, TIGECYCLINE TYKERB, LAPATINIB DITOSYLATE TYLENOL (CAPLET), ACETAMINOPHEN (OTC) TYLENOL (GELTAB), ACETAMINOPHEN (OTC) TYLENOL W/ CODEINE NO. 3, ACETAMINOPHEN TYLENOL W/ CODEINE NO. 4, ACETAMINOPHEN TYLOX, ACETAMINOPHEN TYVASO, TREPROSTINIL SODIUM TYZEKA, TELBIVUDINE TYZINE, TETRAHYDROZOLINE HYDROCHLORIDE

**

**

U-CORT, HYDROCORTISONE ACETATE ULESFIA, BENZYL ALCOHOL ULORIC, FEBUXOSTAT ULTANE, SEVOFLURANE ULTIVA, REMIFENTANIL HYDROCHLORIDE ULTRACET, ACETAMINOPHEN ULTRAM ER, TRAMADOL HYDROCHLORIDE ULTRAM, TRAMADOL HYDROCHLORIDE ULTRATAG, TECHNETIUM TC-99M RED BLOOD CELL KIT ULTRA-TECHNEKOW FM, TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR ULTRAVATE, HALOBETASOL PROPIONATE ULTRAVIST (PHARMACY BULK), IOPROMIDE ULTRAVIST 150, IOPROMIDE ULTRAVIST 240, IOPROMIDE ULTRAVIST 300 IN PLASTIC CONTAINER, IOPROMIDE ULTRAVIST 300, IOPROMIDE ULTRAVIST 370, IOPROMIDE UNASYN, AMPICILLIN SODIUM UNIRETIC, HYDROCHLOROTHIAZIDE UNISOM, DOXYLAMINE SUCCINATE (OTC) UNITHROID, LEVOTHYROXINE SODIUM UNIVASC, MOEXIPRIL HYDROCHLORIDE URECHOLINE, BETHANECHOL CHLORIDE UREX, METHENAMINE HIPPURATE UROCIT-K, POTASSIUM CITRATE UROXATRAL, ALFUZOSIN HYDROCHLORIDE URSO 250, URSODIOL URSO FORTE, URSODIOL URSODIOL, URSODIOL UVADEX, METHOXSALEN

**

**

VAGIFEM, ESTRADIOL VAGISTAT-1, TIOCONAZOLE (OTC) VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE VALCYTE, VALGANCICLOVIR HYDROCHLORIDE VALIUM, DIAZEPAM VALNAC, BETAMETHASONE VALERATE VALPROATE SODIUM, VALPROATE SODIUM VALPROIC ACID, VALPROIC ACID VALSTAR PRESERVATIVE FREE, VALRUBICIN VALTREX, VALACYCLOVIR HYDROCHLORIDE VALTROPIN, SOMATROPIN RECOMBINANT

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

**

PRODUCT NAME INDEX

V **

A - 56

VALTURNA, ALISKIREN HEMIFUMARATE VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER, VANCOMYCIN HYDROCHLORIDE VANCOCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE VANDAZOLE, METRONIDAZOLE VANDETANIB, VANDETANIB VANIQA, EFLORNITHINE HYDROCHLORIDE VANOS, FLUOCINONIDE VANTAS, HISTRELIN ACETATE VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER, CONIVAPTAN HYDROCHLORIDE VASERETIC, ENALAPRIL MALEATE VASOCIDIN, PREDNISOLONE SODIUM PHOSPHATE VASOTEC, ENALAPRIL MALEATE VECTICAL, CALCITRIOL VECURONIUM BROMIDE, VECURONIUM BROMIDE VELCADE, BORTEZOMIB VELETRI, EPOPROSTENOL SODIUM VELIVET, DESOGESTREL VELTIN, CLINDAMYCIN PHOSPHATE VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE VENOFER, IRON SUCROSE VENTAVIS, ILOPROST VENTOLIN HFA, ALBUTEROL SULFATE VERAMYST, FLUTICASONE FUROATE VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE VERDESO, DESONIDE VEREGEN, SINECATECHINS VERELAN PM, VERAPAMIL HYDROCHLORIDE VERELAN, VERAPAMIL HYDROCHLORIDE VESICARE, SOLIFENACIN SUCCINATE VEXOL, RIMEXOLONE VFEND, VORICONAZOLE VIAGRA, SILDENAFIL CITRATE VIBATIV, TELAVANCIN HYDROCHLORIDE VIBISONE, CYANOCOBALAMIN VIBRAMYCIN, DOXYCYCLINE VIBRAMYCIN, DOXYCYCLINE CALCIUM VIBRAMYCIN, DOXYCYCLINE HYCLATE VICODIN ES, ACETAMINOPHEN VICODIN HP, ACETAMINOPHEN VICODIN, ACETAMINOPHEN VICOPROFEN, HYDROCODONE BITARTRATE VICTOZA, LIRAGLUTIDE RECOMBINANT VICTRELIS, BOCEPREVIR VIDAZA, AZACITIDINE VIDEX EC, DIDANOSINE VIDEX, DIDANOSINE VIGAMOX, MOXIFLOXACIN HYDROCHLORIDE VIIBRYD, VILAZODONE HYDROCHLORIDE VIMOVO, ESOMEPRAZOLE MAGNESIUM VIMPAT, LACOSAMIDE VINBLASTINE SULFATE, VINBLASTINE SULFATE VINCRISTINE SULFATE PFS, VINCRISTINE SULFATE VINORELBINE TARTRATE, VINORELBINE TARTRATE VIRACEPT, NELFINAVIR MESYLATE VIRAMUNE XR, NEVIRAPINE VIRAMUNE, NEVIRAPINE VIRAZOLE, RIBAVIRIN VIREAD, TENOFOVIR DISOPROXIL FUMARATE VIROPTIC, TRIFLURIDINE VISICOL, SODIUM PHOSPHATE, DIBASIC ANHYDROUS VISINE L.R., OXYMETAZOLINE HYDROCHLORIDE (OTC) VISINE-A, NAPHAZOLINE HYDROCHLORIDE (OTC)

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A
VISIONBLUE, TRYPAN BLUE VISIPAQUE 270, IODIXANOL VISIPAQUE 320, IODIXANOL VISTARIL, HYDROXYZINE PAMOATE VISTIDE, CIDOFOVIR VISUDYNE, VERTEPORFIN VITAMIN D, ERGOCALCIFEROL VITAMIN K1, PHYTONADIONE VITRASE, HYALURONIDASE VITRASERT, GANCICLOVIR VIVACTIL, PROTRIPTYLINE HYDROCHLORIDE VIVELLE, ESTRADIOL VIVELLE-DOT, ESTRADIOL VIVITROL, NALTREXONE VOLTAREN, DICLOFENAC SODIUM VOLTAREN-XR, DICLOFENAC SODIUM VORICONAZOLE, VORICONAZOLE VOSOL HC, ACETIC ACID, GLACIAL VOSOL, ACETIC ACID, GLACIAL VOSPIRE ER, ALBUTEROL SULFATE VOTRIENT, PAZOPANIB HYDROCHLORIDE VPRIV, VELAGLUCERASE ALFA VUMON, TENIPOSIDE VUSION, MICONAZOLE NITRATE VYTORIN, EZETIMIBE VYVANSE, LISDEXAMFETAMINE DIMESYLATE

**

PRODUCT NAME INDEX

V **

A - 57

**
WARFARIN SODIUM, WARFARIN SODIUM WELCHOL, COLESEVELAM HYDROCHLORIDE WELLBUTRIN SR, BUPROPION HYDROCHLORIDE WELLBUTRIN XL, BUPROPION HYDROCHLORIDE WELLBUTRIN, BUPROPION HYDROCHLORIDE WESTCORT, HYDROCORTISONE VALERATE

**

**

**

XALATAN, LATANOPROST XALKORI, CRIZOTINIB XANAX XR, ALPRAZOLAM XANAX, ALPRAZOLAM XARELTO, RIVAROXABAN XELODA, CAPECITABINE XENAZINE, TETRABENAZINE XENICAL, ORLISTAT XENON XE 133, XENON XE-133 XERESE, ACYCLOVIR XIFAXAN, RIFAXIMIN XOLEGEL, KETOCONAZOLE XOPENEX HFA, LEVALBUTEROL TARTRATE XOPENEX, LEVALBUTEROL HYDROCHLORIDE XYLOCAINE 4% PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE XYLOCAINE DENTAL WITH EPINEPHRINE, EPINEPHRINE XYLOCAINE DENTAL, LIDOCAINE HYDROCHLORIDE XYLOCAINE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE XYLOCAINE VISCOUS, LIDOCAINE HYDROCHLORIDE XYLOCAINE W/ EPINEPHRINE, EPINEPHRINE XYLOCAINE, LIDOCAINE HYDROCHLORIDE XYREM, SODIUM OXYBATE XYZAL, LEVOCETIRIZINE DIHYDROCHLORIDE

**
YASMIN, DROSPIRENONE

**

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A
YAZ, DROSPIRENONE

**

PRODUCT NAME INDEX

Y **

A - 58

**

**

ZADITOR, KETOTIFEN FUMARATE (OTC) ZAFIRLUKAST, ZAFIRLUKAST ZALEPLON, ZALEPLON ZANAFLEX, TIZANIDINE HYDROCHLORIDE ZANOSAR, STREPTOZOCIN ZANTAC 150, RANITIDINE HYDROCHLORIDE ZANTAC 150, RANITIDINE HYDROCHLORIDE (OTC) ZANTAC 25, RANITIDINE HYDROCHLORIDE ZANTAC 300, RANITIDINE HYDROCHLORIDE ZANTAC 75, RANITIDINE HYDROCHLORIDE (OTC) ZANTAC IN PLASTIC CONTAINER, RANITIDINE HYDROCHLORIDE ZANTAC, RANITIDINE HYDROCHLORIDE ZARONTIN, ETHOSUXIMIDE ZAROXOLYN, METOLAZONE ZAVESCA, MIGLUSTAT ZEBETA, BISOPROLOL FUMARATE ZEGERID OTC, OMEPRAZOLE (OTC) ZEGERID, OMEPRAZOLE ZELAPAR, SELEGILINE HYDROCHLORIDE ZELBORAF, VEMURAFENIB ZEMPLAR, PARICALCITOL ZEMURON, ROCURONIUM BROMIDE ZENPEP, LIPASE ZERIT, STAVUDINE ZESTORETIC, HYDROCHLOROTHIAZIDE ZESTRIL, LISINOPRIL ZETIA, EZETIMIBE ZIAC, BISOPROLOL FUMARATE ZIAGEN, ABACAVIR SULFATE ZIANA, CLINDAMYCIN PHOSPHATE ZIDOVUDINE, ZIDOVUDINE ZINACEF IN PLASTIC CONTAINER, CEFUROXIME SODIUM ZINACEF, CEFUROXIME SODIUM ZINC CHLORIDE IN PLASTIC CONTAINER, ZINC CHLORIDE ZINECARD, DEXRAZOXANE HYDROCHLORIDE ZIPSOR, DICLOFENAC POTASSIUM ZIRGAN, GANCICLOVIR ZITHROMAX, AZITHROMYCIN ZMAX, AZITHROMYCIN ZOCOR, SIMVASTATIN ZOFRAN ODT, ONDANSETRON ZOFRAN PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE ZOFRAN, ONDANSETRON HYDROCHLORIDE ZOLADEX, GOSERELIN ACETATE ZOLINZA, VORINOSTAT ZOLOFT, SERTRALINE HYDROCHLORIDE ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE ZOLPIDEM TATRATE, ZOLPIDEM TARTRATE ZOLPIMIST, ZOLPIDEM TARTRATE ZOMETA, ZOLEDRONIC ACID ZOMIG, ZOLMITRIPTAN ZOMIG-ZMT, ZOLMITRIPTAN ZONALON, DOXEPIN HYDROCHLORIDE ZONEGRAN, ZONISAMIDE ZONISAMIDE, ZONISAMIDE ZORBTIVE, SOMATROPIN RECOMBINANT ZORTRESS, EVEROLIMUS ZOSYN IN PLASTIC CONTAINER, PIPERACILLIN SODIUM ZOSYN, PIPERACILLIN SODIUM ZOVIA 1/35E-28, ETHINYL ESTRADIOL

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

**

PRODUCT NAME INDEX

Z **

A - 59

ZOVIA 1/50E-28, ETHINYL ESTRADIOL ZOVIRAX, ACYCLOVIR ZUPLENZ, ONDANSETRON ZUTRIPRO, CHLORPHENIRAMINE MALEATE ZYBAN, BUPROPION HYDROCHLORIDE ZYCLARA, IMIQUIMOD ZYDONE, ACETAMINOPHEN ZYFLO CR, ZILEUTON ZYFLO, ZILEUTON ZYLET, LOTEPREDNOL ETABONATE ZYLOPRIM, ALLOPURINOL ZYMAR, GATIFLOXACIN ZYMAXID, GATIFLOXACIN ZYPREXA RELPREVV, OLANZAPINE PAMOATE ZYPREXA ZYDIS, OLANZAPINE ZYPREXA, OLANZAPINE ZYRTEC ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) ZYRTEC HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) ZYRTEC, CETIRIZINE HYDROCHLORIDE ZYRTEC-D 12 HOUR, CETIRIZINE HYDROCHLORIDE (OTC) ZYTIGA, ABIRATERONE ACETATE ZYVOX, LINEZOLID

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

B - 1

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** 3 **

3M * 3M CO PERIDEX, CHLORHEXIDINE GLUCONATE * 3M HEALTH CARE INC

AVAGARD, ALCOHOL (OTC)

DURAPREP, IODINE POVACRYLEX (OTC)
* 3M PHARMACEUTICALS INC PROVENTIL-HFA, ALBUTEROL SULFATE 3M INFECTION * 3M INFECTION PREVENTION DIV CHLORASCRUB MAXI SWABSTICK, CHLORHEXIDINE GLUCONATE (OTC)
CHLORASCRUB SWAB, CHLORHEXIDINE GLUCONATE (OTC)

CHLORASCRUB SWABSTICK, CHLORHEXIDINE GLUCONATE (OTC)
AAIPHARMA LLC * AAIPHARMA LLC AZASAN, AZATHIOPRINE ABBOTT * ABBOTT LABORATORIES ADVICOR, LOVASTATIN AKINETON, BIPERIDEN HYDROCHLORIDE AZMACORT, TRIAMCINOLONE ACETONIDE BIAXIN XL, CLARITHROMYCIN BIAXIN, CLARITHROMYCIN CYCLOSPORINE, CYCLOSPORINE DEPAKOTE ER, DIVALPROEX SODIUM DEPAKOTE, DIVALPROEX SODIUM GENGRAF, CYCLOSPORINE KALETRA, LOPINAVIR NIASPAN, NIACIN NIMBEX PRESERVATIVE FREE, CISATRACURIUM BESYLATE NIMBEX, CISATRACURIUM BESYLATE NORVIR, RITONAVIR SIMCOR, NIACIN SYNTHROID, LEVOTHYROXINE SODIUM TEVETEN HCT, EPROSARTAN MESYLATE TEVETEN, EPROSARTAN MESYLATE
ULTANE, SEVOFLURANE

ZEMPLAR, PARICALCITOL
* ABBOTT LABORATORIES HOSP PRODUCTS DIV CALCIJEX, CALCITRIOL * ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV BIAXIN, CLARITHROMYCIN DEPACON, VALPROATE SODIUM DEPAKENE, VALPROIC ACID DEPAKOTE, DIVALPROEX SODIUM ENDURON, METHYCLOTHIAZIDE HYTRIN, TERAZOSIN HYDROCHLORIDE K-TAB, POTASSIUM CHLORIDE MAVIK, TRANDOLAPRIL NORVIR, RITONAVIR ORETIC, HYDROCHLOROTHIAZIDE POTASSIUM CHLORIDE, POTASSIUM CHLORIDE TARKA, TRANDOLAPRIL TRIDIONE, TRIMETHADIONE VICODIN ES, ACETAMINOPHEN VICODIN HP, ACETAMINOPHEN VICODIN, ACETAMINOPHEN
VICOPROFEN, HYDROCODONE BITARTRATE

ZEMPLAR, PARICALCITOL
ABBOTT ENDOCRINE * ABBOTT ENDOCRINE INC LUPRON DEPOT, LEUPROLIDE ACETATE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

B - 2

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** A **

* ABBOTT ENDOCRINE INC LUPRON DEPOT-PED, LEUPROLIDE ACETATE ABBOTT LABS * ABBOTT ENDOCRINE INC SUB ABBOTT LABORATORIES LUPRON DEPOT, LEUPROLIDE ACETATE * ABBOTT LABORATORIES ANDROGEL, TESTOSTERONE NORVIR, RITONAVIR PROMETRIUM, PROGESTERONE

TRILIPIX, CHOLINE FENOFIBRATE

ABBOTT LABS PHARM * ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV TRICOR, FENOFIBRATE ABBOTT PRODS * ABBOTT PRODUCTS INC ACEON, PERINDOPRIL ERBUMINE CREON, LIPASE

MARINOL, DRONABINOL

ABRAXIS BIOSCIENCE * ABRAXIS BIOSCIENCE LLC ABRAXANE, PACLITAXEL ABRAXIS PHARM * ABRAXIS PHARMACEUTICAL PRODUCTS CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%, CLINDAMYCIN PHOSPHATE LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE

MAGNESIUM SULFATE, MAGNESIUM SULFATE

ACADEMIC PHARMS * ACADEMIC PHARMACEUTICALS INC SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE ACCORD HLTH * ACCORD HEALTH CARE INC METHYLDOPA, METHYLDOPA ACCORD HLTHCARE * ACCORD HEALTHCARE INC DOCETAXEL, DOCETAXEL DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE GLIMEPIRIDE, GLIMEPIRIDE IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE LETROZOLE, LETROZOLE LEVETIRACETAM, LEVETIRACETAM MITOMYCIN, MITOMYCIN MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE SIMVASTATIN, SIMVASTATIN
TACROLIMUS, TACROLIMUS

TOPIRAMATE, TOPIRAMATE
ACCORD HLTHCARE INC * ACCORD HEALTHCARE INC USA ANASTROZOLE, ANASTROZOLE BICALUTAMIDE, BICALUTAMIDE CLONAZEPAM, CLONAZEPAM ETOPOSIDE, ETOPOSIDE FINASTERIDE, FINASTERIDE GLIPIZIDE, GLIPIZIDE
MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL

PACLITAXEL, PACLITAXEL
ACIC FINE CHEMS * ACIC FINE CHEMICALS INC AMPICILLIN SODIUM, AMPICILLIN SODIUM

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

B - 3

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** A **

* ACIC FINE CHEMICALS INC NAFCILLIN SODIUM, NAFCILLIN SODIUM ACORDA * ACORDA THERAPEUTICS INC AMPYRA, DALFAMPRIDINE

ZANAFLEX, TIZANIDINE HYDROCHLORIDE

ACS DOBFAR * ACS DOBFAR SPA AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM CEFAZOLIN SODIUM, CEFAZOLIN SODIUM CEFEPIME HYDROCHLORIDE, CEFEPIME HYDROCHLORIDE CEFOXITIN, CEFOXITIN SODIUM CEFTAZIDIME, CEFTAZIDIME CEFTRIAXONE, CEFTRIAXONE SODIUM IMIPENEM AND CILASTATIN, CILASTATIN SODIUM KEFZOL, CEFAZOLIN SODIUM

MEROPENEM, MEROPENEM

ACS DOBFAR INFO SA * ACS DOBFAR INFO SA CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN FLUCANAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN ACTAVIS * ACTAVIS SOUTH ATLANTIC LLC METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE * ACTAVIS SOUTHATLANTIC LLC BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE FENTANYL-100, FENTANYL FENTANYL-25, FENTANYL FENTANYL-50, FENTANYL FENTANYL-75, FENTANYL
NIFEDIPINE, NIFEDIPINE

OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE
ACTAVIS ELIZABETH * ACTAVIS ELIZABETH LLC ALPRAZOLAM, ALPRAZOLAM CARBIDOPA AND LEVODOPA, CARBIDOPA CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE CLONAZEPAM, CLONAZEPAM CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE DICLOFENAC SODIUM, DICLOFENAC SODIUM DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE GABAPENTIN, GABAPENTIN GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE INDAPAMIDE, INDAPAMIDE ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE KADIAN, MORPHINE SULFATE LEVETIRACETAM, LEVETIRACETAM LORAZEPAM, LORAZEPAM LOVASTATIN, LOVASTATIN METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE MIRTAZAPINE, MIRTAZAPINE NIFEDIPINE, NIFEDIPINE OXAZEPAM, OXAZEPAM OXYCODONE HYDROCHLORIDE AND IBUPROFEN, IBUPROFEN PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE PROPYLTHIOURACIL, PROPYLTHIOURACIL
SPIRONOLACTONE, SPIRONOLACTONE

TEMAZEPAM, TEMAZEPAM

(OTC)

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B - 4

APPENDIX B
ACTAVIS INC * ACTAVIS INC LOSARTAN POTASSIUM,

PRODUCT NAME SORTED BY APPLICANT

** A **

LOSARTAN POTASSIUM

ACTAVIS MID ATLANTIC * ACTAVIS MID ATLANTIC LLC ACETAMINOPHEN, ACETAMINOPHEN (OTC) ACETASOL HC, ACETIC ACID, GLACIAL ACYCLOVIR, ACYCLOVIR ALBUTEROL SULFATE, ALBUTEROL SULFATE BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE BETAMETHASONE VALERATE, BETAMETHASONE VALERATE CICLOPIROX, CICLOPIROX CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE CLOTRIMAZOLE, CLOTRIMAZOLE (OTC) CONSTULOSE, LACTULOSE ENULOSE, LACTULOSE FLUOCINONIDE, FLUOCINONIDE GRISEOFULVIN, GRISEOFULVIN, MICROCRYSTALLINE HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE, HOMATROPINE METHYLBROMIDE HYDROCORTISONE, HYDROCORTISONE IBUPROFEN, IBUPROFEN IBUPROFEN, IBUPROFEN (OTC) INFANTS' FEVERALL, ACETAMINOPHEN (OTC) LEVETIRACETAM, LEVETIRACETAM MICONAZOLE 7, MICONAZOLE NITRATE (OTC) MICONAZOLE NITRATE, MICONAZOLE NITRATE MICONAZOLE NITRATE, MICONAZOLE NITRATE (OTC) MINOXIDIL (FOR MEN), MINOXIDIL (OTC) MINOXIDIL EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC) M-ZOLE 3 COMBINATION PACK, MICONAZOLE NITRATE (OTC) NYSTATIN, NYSTATIN PERMETHRIN, PERMETHRIN PERMETHRIN, PERMETHRIN (OTC) PROMETH VC PLAIN, PHENYLEPHRINE HYDROCHLORIDE PROMETH VC W/ CODEINE, CODEINE PHOSPHATE PROMETH W/ DEXTROMETHORPHAN, DEXTROMETHORPHAN HYDROBROMIDE PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
SULFATRIM PEDIATRIC, SULFAMETHOXAZOLE

VALNAC, BETAMETHASONE VALERATE
ACTAVIS PHARMA * ACTAVIS PHARMA MANUFACTURING PRIVATE LTD DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE
ACTAVIS S ATLANTIC * ACTAVIS SOUTH ATLANTIC LLC
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

ZOLPIDEM TATRATE, ZOLPIDEM TARTRATE
ACTAVIS TOTOWA * ACTAVIS TOTOWA LLC BICALUTAMIDE, BICALUTAMIDE DESIPRAMINE HYDROCHLORIDE, DESIPRAMINE HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE FINASTERIDE, FINASTERIDE FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE LAMOTRIGINE, LAMOTRIGINE
LETROZOLE, LETROZOLE

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

B - 5

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** A **

* ACTAVIS TOTOWA LLC PACLITAXEL, PACLITAXEL PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

VINORELBINE TARTRATE, VINORELBINE TARTRATE

ACTELION * ACTELION LTD TRACLEER, BOSENTAN

VELETRI, EPOPROSTENOL SODIUM

ACTELION PHARMS LTD * ACTELION PHARMACEUTICALS LTD VENTAVIS, ILOPROST

ZAVESCA, MIGLUSTAT

ACTIENT PHARMS * ACTIENT PHARMACEUTICALS LLC STRIANT, TESTOSTERONE ACTON PHARMS * ACTON PHARMACEUTICALS INC AEROSPAN HFA, FLUNISOLIDE ADOLOR * ADOLOR CORP ENTEREG, ALVIMOPAN ADVENT PHARMS * ADVENT PHARMACEUTICALS INC CARISOPRODOL, CARISOPRODOL AEGIS PHARMS * AEGIS PHARMACEUTICALS INC TAMOXIFEN CITRATE, TAMOXIFEN CITRATE AGOURON * AGOURON PHARMACEUTICALS INC VIRACEPT, NELFINAVIR MESYLATE AJANTA PHARMA * AJANTA PHARMA LTD LEVETIRACETAM, LEVETIRACETAM AJANTA PHARMA LTD * AJANTA PHARMA LTD RISPERIDONE, RISPERIDONE AKORN * AKORN INC ADENOSINE, ADENOSINE AKBETA, LEVOBUNOLOL HYDROCHLORIDE AK-FLUOR 10%, FLUORESCEIN SODIUM AKPENTOLATE, CYCLOPENTOLATE HYDROCHLORIDE AKPRO, DIPIVEFRIN HYDROCHLORIDE AKTEN, LIDOCAINE HYDROCHLORIDE AKTOB, TOBRAMYCIN ALFENTA, ALFENTANIL HYDROCHLORIDE AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE BACITRACIN ZINC AND POLYMYXIN B SULFATE, BACITRACIN ZINC BAL, DIMERCAPROL BALANCED SALT, CALCIUM CHLORIDE BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE CALCITRIOL, CALCITRIOL CAPASTAT SULFATE, CAPREOMYCIN SULFATE CARBOPLATIN, CARBOPLATIN CROMOLYN SODIUM, CROMOLYN SODIUM DICLOFENAC SODIUM, DICLOFENAC SODIUM

ENDOSOL EXTRA, CALCIUM CHLORIDE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

B - 6

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** A **

* AKORN INC ERYTHROMYCIN, ERYTHROMYCIN GENTAK, GENTAMICIN SULFATE GENTAMICIN SULFATE, GENTAMICIN SULFATE HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE IC-GREEN, INDOCYANINE GREEN IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE KETOTIFEN FUMARATE, KETOTIFEN FUMARATE (OTC) LEVOFLOXACIN, LEVOFLOXACIN LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC, BACITRACIN ZINC OFLOXACIN, OFLOXACIN ORPHENADRINE CITRATE, ORPHENADRINE CITRATE PAREMYD, HYDROXYAMPHETAMINE HYDROBROMIDE SUBLIMAZE PRESERVATIVE FREE, FENTANYL CITRATE SUFENTA PRESERVATIVE FREE, SUFENTANIL CITRATE TERBUTALINE SULFATE, TERBUTALINE SULFATE TIMOLOL MALEATE, TIMOLOL MALEATE

TROPICACYL, TROPICAMIDE

AKORN INC * AKORN INC APRACLONIDINE HYDROCHLORIDE, APRACLONIDINE HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE HYDASE, HYALURONIDASE

INAPSINE, DROPERIDOL

AKORN STRIDES * AKORN STRIDES LLC TOBRAMYCIN SULFATE,

TOBRAMYCIN SULFATE

AKRIMAX PHARMS * AKRIMAX PHARMACEUTICALS LLC INDERAL LA, PROPRANOLOL HYDROCHLORIDE INDERAL, PROPRANOLOL HYDROCHLORIDE

INDERIDE-40/25, HYDROCHLOROTHIAZIDE

ALARA PHARM * ALARA PHARMACEUTICAL CORPORATION LEVO-T, LEVOTHYROXINE SODIUM ALCON * ALCON INC TRIESENCE, TRIAMCINOLONE ACETONIDE * ALCON LABORATORIES INC ALCAINE, PROPARACAINE HYDROCHLORIDE ALOMIDE, LODOXAMIDE TROMETHAMINE BETOPTIC S, BETAXOLOL HYDROCHLORIDE BETOPTIC, BETAXOLOL HYDROCHLORIDE BSS PLUS, CALCIUM CHLORIDE BSS, CALCIUM CHLORIDE CARTEOLOL HYDROCHLORIDE, CARTEOLOL HYDROCHLORIDE CETAMIDE, SULFACETAMIDE SODIUM CROMOLYN SODIUM, CROMOLYN SODIUM CYCLOGYL, CYCLOPENTOLATE HYDROCHLORIDE CYCLOMYDRIL, CYCLOPENTOLATE HYDROCHLORIDE DENDRID, IDOXURIDINE EMADINE, EMEDASTINE DIFUMARATE FLAREX, FLUOROMETHOLONE ACETATE IOPIDINE, APRACLONIDINE HYDROCHLORIDE MAXIDEX, DEXAMETHASONE MAXITROL, DEXAMETHASONE

MIOSTAT, CARBACHOL

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

B - 7

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** A **

* ALCON LABORATORIES INC MYDRIACYL, TROPICAMIDE NAPHCON-A, NAPHAZOLINE HYDROCHLORIDE (OTC) NATACYN, NATAMYCIN NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE, OMNIPRED, PREDNISOLONE ACETATE PATANOL, OLOPATADINE HYDROCHLORIDE PILOPINE HS, PILOCARPINE HYDROCHLORIDE TOBRADEX, DEXAMETHASONE TOBREX, TOBRAMYCIN TRIFLURIDINE, TRIFLURIDINE
VEXOL, RIMEXOLONE
ALCON PHARMA * ALCON RESEARCH LTD ZADITOR, KETOTIFEN FUMARATE

HYDROCORTISONE

(OTC)

ALCON PHARMS LTD * ALCON PHARMACEUTICALS LTD AZOPT, BRINZOLAMIDE BETADINE, POVIDONE-IODINE BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE CILOXAN, CIPROFLOXACIN HYDROCHLORIDE CIPRO HC, CIPROFLOXACIN HYDROCHLORIDE CIPRODEX, CIPROFLOXACIN DICLOFENAC SODIUM, DICLOFENAC SODIUM DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE DUREZOL, DIFLUPREDNATE FLUORESCITE, FLUORESCEIN SODIUM KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE KETOTIFEN FUMARATE, KETOTIFEN FUMARATE (OTC) MOXEZA, MOXIFLOXACIN HYDROCHLORIDE NAVSTEL, CALCIUM CHLORIDE NEVANAC, NEPAFENAC OFLOXACIN, OFLOXACIN PATADAY, OLOPATADINE HYDROCHLORIDE PATANASE, OLOPATADINE HYDROCHLORIDE SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE, TOBRADEX ST, DEXAMETHASONE TRAVATAN Z, TRAVOPROST
VIGAMOX, MOXIFLOXACIN HYDROCHLORIDE
ALCON RES * ALCON RESEARCH LTD DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, ISOPTO CARPINE, PILOCARPINE HYDROCHLORIDE
LATANOPROST, LATANOPROST

PREDNISOLONE SODIUM PHOSPHATE

DORZOLAMIDE HYDROCHLORIDE

ALCON UNIVERSAL * ALCON UNIVERSAL LTD DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE, DEXAMETHASONE NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE, HYDROCORTISONE
SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM
ALDOPHARMA USA * ALKOPHARMA USA INC AMPHOTEC, AMPHOTERICIN B ALEMBIC LTD * ALEMBIC LTD LITHIUM CARBONATE, LITHIUM CARBONATE METRONIDAZOLE, METRONIDAZOLE PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE
THEOPHYLLINE, THEOPHYLLINE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

B - 8

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** A **

ALEMBIC PHARMS LTD * ALEMBIC PHARMACEUTICALS LTD CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE FAMOTIDINE, FAMOTIDINE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LAMOTRIGINE, LAMOTRIGINE LEFLUNOMIDE, LEFLUNOMIDE LOSARTAN POTASSIUM, LOSARTAN POTASSIUM MEPROBAMATE, MEPROBAMATE
METRONIDAZOLE, METRONIDAZOLE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
ALKEM * ALKEM LABORATORIES LTD AMLODIPINE BESYLATE, AMLODIPINE BESYLATE CEPHALEXIN, CEPHALEXIN
GABAPENTIN, GABAPENTIN

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
ALKEM LABS LTD * ALKEM LABORATORIES LTD
CEFUROXIME AXETIL, CEFUROXIME AXETIL

MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL
ALKERMES * ALKERMES INC VIVITROL, NALTREXONE ALKERMES GAINESVILLE * ALKERMES GAINESVILLE LLC VERELAN, VERAPAMIL HYDROCHLORIDE ALLEGIANCE HLTHCARE * ALLEGIANCE HEALTHCARE CORP POVIDONE IODINE, POVIDONE-IODINE

(OTC)

ALLERGAN * ALLERGAN ACULAR LS, KETOROLAC TROMETHAMINE ALPHAGAN P, BRIMONIDINE TARTRATE BLEPH-10, SULFACETAMIDE SODIUM
GENOPTIC, GENTAMICIN SULFATE

ZYMAXID, GATIFLOXACIN
* ALLERGAN INC ACULAR PRESERVATIVE FREE, KETOROLAC TROMETHAMINE ACULAR, KETOROLAC TROMETHAMINE ACUVAIL, KETOROLAC TROMETHAMINE ACZONE, DAPSONE ALBALON, NAPHAZOLINE HYDROCHLORIDE ALOCRIL, NEDOCROMIL SODIUM ALPHAGAN P, BRIMONIDINE TARTRATE AVAGE, TAZAROTENE AZELEX, AZELAIC ACID COMBIGAN, BRIMONIDINE TARTRATE ELESTAT, EPINASTINE HYDROCHLORIDE ELIMITE, PERMETHRIN LASTACAFT, ALCAFTADINE LATISSE, BIMATOPROST LUMIGAN, BIMATOPROST OCUFLOX, OFLOXACIN OPTICROM, CROMOLYN SODIUM OZURDEX, DEXAMETHASONE POLYTRIM, POLYMYXIN B SULFATE RESTASIS, CYCLOSPORINE
SANCTURA XR, TROSPIUM CHLORIDE

SANCTURA, TROSPIUM CHLORIDE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

B - 9

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** A **

* ALLERGAN INC TAZORAC, TAZAROTENE TRIVARIS, TRIAMCINOLONE ACETONIDE

ZYMAR, GATIFLOXACIN

* ALLERGAN PHARMACEUTICAL BETAGAN, LEVOBUNOLOL HYDROCHLORIDE BLEPHAMIDE S.O.P., PREDNISOLONE ACETATE BLEPHAMIDE, PREDNISOLONE ACETATE FML FORTE, FLUOROMETHOLONE FML, FLUOROMETHOLONE HERPLEX, IDOXURIDINE OCUFEN, FLURBIPROFEN SODIUM OPHTHETIC, PROPARACAINE HYDROCHLORIDE POLY-PRED, NEOMYCIN SULFATE PRED FORTE, PREDNISOLONE ACETATE PRED MILD, PREDNISOLONE ACETATE PRED-G, GENTAMICIN SULFATE

PROPINE, DIPIVEFRIN HYDROCHLORIDE

ALLERGAN HERBERT * ALLERGAN HERBERT SKIN CARE DIV ALLERGAN INC FLUOROPLEX, FLUOROURACIL ALLERQUEST * ALLERQUEST LLC PRE-PEN, BENZYLPENICILLOYL POLYLYSINE ALLOS * ALLOS THERAPEUTICS INC FOLOTYN, PRALATREXATE ALPHAPHARM * ALPHAPHARM PARTY LTD ALPRAZOLAM, ALPRAZOLAM CILOSTAZOL, CILOSTAZOL CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE CLONAZEPAM, CLONAZEPAM DICLOFENAC SODIUM, DICLOFENAC SODIUM FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE INDAPAMIDE, INDAPAMIDE METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE MIRTAZAPINE, MIRTAZAPINE NAPROXEN, NAPROXEN TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
TRIAZOLAM, TRIAZOLAM

ZONISAMIDE, ZONISAMIDE
* ALPHAPHARM PTY LTD ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE
PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE
ALPHARMA * ALPHARMA USPD INC
PREDNISOLONE, PREDNISOLONE

VALPROIC ACID, VALPROIC ACID
ALPHARMA KING * ALPHARMA PHARMACEUTICALS LLC KING PHARMACEUTICALS EMBEDA, MORPHINE SULFATE ALRA * ALRA LABORATORIES INC CHOLAC, LACTULOSE CONSTILAC, LACTULOSE GEN-XENE, CLORAZEPATE DIPOTASSIUM IBU-TAB 200, IBUPROFEN (OTC)

IBU-TAB, IBUPROFEN

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** A **

ALTAIRE PHARMS INC * ALTAIRE PHARMACEUTICALS INC NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE,

NAPHAZOLINE HYDROCHLORIDE

(OTC)

ALTANA * ALTANA INC ALCLOMETASONE DIPROPIONATE, ALCLOMETASONE DIPROPIONATE AMCINONIDE, AMCINONIDE BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE CICLOPIROX, CICLOPIROX CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE CLOBETASOL PROPIONATE (EMOLLIENT), CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE CUTIVATE, FLUTICASONE PROPIONATE DESONIDE, DESONIDE DIFLORASONE DIACETATE, DIFLORASONE DIACETATE ECONAZOLE NITRATE, ECONAZOLE NITRATE ERYTHROMYCIN, ERYTHROMYCIN FLUOCINONIDE EMULSIFIED BASE, FLUOCINONIDE FLUOCINONIDE, FLUOCINONIDE FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE HYDROCORTISONE VALERATE, HYDROCORTISONE VALERATE HYDROCORTISONE, HYDROCORTISONE KETOCONAZOLE, KETOCONAZOLE METRONIDAZOLE, METRONIDAZOLE MOMETASONE FUROATE, MOMETASONE FUROATE MUPIROCIN, MUPIROCIN NYSTATIN, NYSTATIN OXISTAT, OXICONAZOLE NITRATE PREDNICARBATE, PREDNICARBATE SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM
TERCONAZOLE, TERCONAZOLE

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE
ALTANA PHARMA * ALTANA PHARMA AG CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, ALTERNA TCHP LLC * ALTERNA TCHP LLC CHILDREN'S ELIXSURE,

BETAMETHASONE DIPROPIONATE

IBUPROFEN

(OTC)

ALVOGEN * ALVOGEN INC MACROBID, NITROFURANTOIN MACRODANTIN, NITROFURANTOIN, MACROCRYSTALLINE METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE
ALVOGEN INC * ALVOGEN INC OXYCODONE HYDROCHLORIDE, AM ANTIBIOTICS * AMERICAN ANTIBIOTICS LLC AMOXICILLIN, AMOXICILLIN AMAG PHARMS INC * AMAG PHARMACEUTICALS INC FERAHEME, FERUMOXYTOL
FERIDEX I.V., FERUMOXIDES

GASTROMARK, FERUMOXSIL

OXYCODONE HYDROCHLORIDE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B
AMGEN * AMGEN INC SENSIPAR,

PRODUCT NAME SORTED BY APPLICANT

** A **

CINACALCET HYDROCHLORIDE

AMNEAL PHARM * AMNEAL PHARMACEUTICAL ACEBUTOLOL HYDROCHLORIDE, ACEBUTOLOL HYDROCHLORIDE BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE DEMECLOCYCLINE HYDROCHLORIDE, DEMECLOCYCLINE HYDROCHLORIDE FLECAINIDE ACETATE, FLECAINIDE ACETATE FLUCONAZOLE, FLUCONAZOLE FOLIC ACID, FOLIC ACID GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
PRIMIDONE, PRIMIDONE

SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE
AMNEAL PHARMS * AMNEAL PHARMACEUTICALS ALBUTEROL SULFATE, ALBUTEROL SULFATE CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) FELBAMATE, FELBAMATE IBUPROFEN, IBUPROFEN (OTC) INDOMETHACIN, INDOMETHACIN LEVETIRACETAM, LEVETIRACETAM LORAZEPAM, LORAZEPAM MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE NITROFURANTOIN, NITROFURANTOIN NIZATIDINE, NIZATIDINE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE, DEXTROMETHORPHAN HYDROBROMIDE PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE RISPERIDONE, RISPERIDONE SPIRONOLACTONE, SPIRONOLACTONE TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE * AMNEAL PHARMACEUTICALS LLC TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE AMNEAL PHARMS NY * AMNEAL PHARMACEUTICALS NY LLC ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN ALPRAZOLAM, ALPRAZOLAM AMLODIPINE BESYLATE, AMLODIPINE BESYLATE CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM GABAPENTIN, GABAPENTIN HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN HYDROCODONE BITARTRATE AND IBUPROFEN, HYDROCODONE BITARTRATE IBUPROFEN, IBUPROFEN IBUPROFEN, IBUPROFEN (OTC) METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE NAPROXEN SODIUM, NAPROXEN SODIUM NAPROXEN SODIUM, NAPROXEN SODIUM (OTC) NAPROXEN, NAPROXEN
OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

B - 12

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** A **

* AMNEAL PHARMACEUTICALS NY LLC RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE REPREXAIN, HYDROCODONE BITARTRATE

SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE

AMPHASTAR PHARM * AMPHASTAR PHARMACEUTICAL INC AMPHADASE, HYALURONIDASE

ENOXAPARIN SODIUM (PRESERVATIVE FREE), AMPHASTAR PHARMS INC * AMPHASTAR PHARMACEUTICALS INC CORTROSYN, COSYNTROPIN AMPOLGEN * AMPOLGEN PHARMACEUTICALS LLC SODIUM PHENYLBUTYRATE, SODIUM PHENYLBUTYRATE AMYLIN * AMYLIN PHARMACEUTICALS INC
BYETTA, EXENATIDE SYNTHETIC

SYMLIN, PRAMLINTIDE ACETATE
ANBEX * ANBEX INC IOSAT, POTASSIUM IODIDE

ENOXAPARIN SODIUM

(OTC)

ANCHEN PHARMS * ANCHEN PHARMACEUTICALS INC BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

LEVETIRACETAM, LEVETIRACETAM

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
* ANCHEN PHARMACEUTICALS TAIWAN INC DIVALPROEX SODIUM, DIVALPROEX SODIUM * ANCHEN PHARMACEUTICALS, INC
ALPRAZOLAM, ALPRAZOLAM

CIPROFLOXACIN EXTENDED RELEASE, CIPROFLOXACIN
ANDRX LABS LLC * ANDRX LABS LLC
ALTOPREV, LOVASTATIN

FORTAMET, METFORMIN HYDROCHLORIDE
ANESTA AG * ANESTA AG AMRIX, CYCLOBENZAPRINE HYDROCHLORIDE ANGELINI LLC * ANGELINI LABOPHARM LLC OLEPTRO, TRAZODONE HYDROCHLORIDE ANI PHARMS * ANI PHARMACEUTICALS INC CORTENEMA, HYDROCORTISONE LACTULOSE, LACTULOSE LUVOX, FLUVOXAMINE MALEATE
METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE

REGLAN, METOCLOPRAMIDE HYDROCHLORIDE
ANTARES PHARMA INC * ANTARES PHARMA INC ANTUROL, OXYBUTYNIN ANTIBIOTICOS BRASIL * ANTIBIOTICOS DO BRASIL LTDA CEFOXITIN, CEFOXITIN APOPHARMA INC * APOPHARMA INC FERRIPROX, DEFERIPRONE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

B - 13

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** A **

APOTEX * APOTEX CORP LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE
* APOTEX INC ALENDRONATE SODIUM, ALENDRONATE SODIUM AMLODIPINE BESYLATE, AMLODIPINE BESYLATE AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN BUDESONIDE, BUDESONIDE BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE CAPTOPRIL, CAPTOPRIL CARBIDOPA AND LEVODOPA, CARBIDOPA CEFUROXIME AXETIL, CEFUROXIME AXETIL CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) CIMETIDINE, CIMETIDINE CIMETIDINE, CIMETIDINE (OTC) CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE CLONAZEPAM, CLONAZEPAM CYCLOSPORINE, CYCLOSPORINE DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM DILT-CD, DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE ENALAPRIL MALEATE, ENALAPRIL MALEATE EPINASTINE HYDROCHLORIDE, EPINASTINE HYDROCHLORIDE EPLERENONE, EPLERENONE ETODOLAC, ETODOLAC FAMCICLOVIR, FAMCICLOVIR FAMOTIDINE, FAMOTIDINE FLUCONAZOLE, FLUCONAZOLE FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE GEMFIBROZIL, GEMFIBROZIL GLIPIZIDE, GLIPIZIDE HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE KETOCONAZOLE, KETOCONAZOLE LAMIVUDINE, LAMIVUDINE LATANOPROST, LATANOPROST LEVETIRACETAM, LEVETIRACETAM LEVOFLOXACIN, LEVOFLOXACIN METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL NIZATIDINE, NIZATIDINE OMEPRAZOLE, OMEPRAZOLE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE PENTOXIFYLLINE, PENTOXIFYLLINE PERINDOPRIL ERBUMINE, PERINDOPRIL ERBUMINE QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE RAMIPRIL, RAMIPRIL RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE SELEGILINE HYDROCHLORIDE, SELEGILINE HYDROCHLORIDE SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE TAMOXIFEN CITRATE, TAMOXIFEN CITRATE TERAZOSIN HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE TICLOPIDINE HYDROCHLORIDE, TICLOPIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE

TROSPIUM CHLORIDE, TROSPIUM CHLORIDE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

B - 14

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** A **

APOTEX CORP * APOTEX CORP ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE AZITHROMYCIN, AZITHROMYCIN CICLOPIROX, CICLOPIROX CLARITHROMYCIN, CLARITHROMYCIN GATIFLOXACIN, GATIFLOXACIN LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL

NARATRIPTAN, NARATRIPTAN
APOTEX INC * APOTEX INC ALBUTEROL SULFATE, ALBUTEROL SULFATE ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE ALPRAZOLAM, ALPRAZOLAM AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE CALCITONIN-SALMON, CALCITONIN SALMON CARBAMAZEPINE, CARBAMAZEPINE CARBIDOPA AND LEVODOPA, CARBIDOPA CEFPROZIL, CEFPROZIL CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE CEVIMELINE, CEVIMELINE HYDROCHLORIDE DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE FLECAINIDE ACETATE, FLECAINIDE ACETATE GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE LAMOTRIGINE, LAMOTRIGINE LEVETIRACETAM, LEVETIRACETAM LEVOFLOXACIN, LEVOFLOXACIN LOVASTATIN, LOVASTATIN MOEXIPRIL HYDROCHLORIDE, MOEXIPRIL HYDROCHLORIDE NABUMETONE, NABUMETONE OFLOXACIN, OFLOXACIN OLANZAPINE, OLANZAPINE OXCARBAZEPINE, OXCARBAZEPINE PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE RISPERIDONE, RISPERIDONE SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE TIMOLOL MALEATE, TIMOLOL MALEATE TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE
TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
* APOTEX INC ETOBICOKE SITE ACYCLOVIR, ACYCLOVIR ALLOPURINOL, ALLOPURINOL AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN BALSALAZIDE DISODIUM, BALSALAZIDE DISODIUM BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE CARBAMAZEPINE, CARBAMAZEPINE CARVEDILOL, CARVEDILOL CILOSTAZOL, CILOSTAZOL CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE DILTZAC, DILTIAZEM HYDROCHLORIDE ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE ETODOLAC, ETODOLAC FOSINOPRIL SODIUM, FOSINOPRIL SODIUM GABAPENTIN, GABAPENTIN
KETOTIFEN FUMARATE, KETOTIFEN FUMARATE (OTC)

LEFLUNOMIDE, LEFLUNOMIDE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

B - 15

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** A **

* APOTEX INC ETOBICOKE SITE LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LISINOPRIL, LISINOPRIL LITHIUM CARBONATE, LITHIUM CARBONATE LORATADINE, LORATADINE (OTC) MELOXICAM, MELOXICAM MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE MIRTAZAPINE, MIRTAZAPINE OXAPROZIN, OXAPROZIN SELEGILINE HYDROCHLORIDE, SELEGILINE HYDROCHLORIDE SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE TOPIRAMATE, TOPIRAMATE TORSEMIDE, TORSEMIDE

ZONISAMIDE, ZONISAMIDE

* APOTEX INC RICHMOND HILL ALBUTEROL SULFATE, ALBUTEROL SULFATE AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION), DESMOPRESSIN ACETATE DICLOFENAC SODIUM, DICLOFENAC SODIUM DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER, FLUCONAZOLE FLUNISOLIDE, FLUNISOLIDE FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE LORATADINE, LORATADINE (OTC) MEGESTROL ACETATE, MEGESTROL ACETATE MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE PREDNISOLONE, PREDNISOLONE

RISPERIDONE, RISPERIDONE

* APOTEX INC. GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE APOTHECON * APOTHECON INC DIV BRISTOL MYERS SQUIBB CAPOZIDE 25/15, CAPTOPRIL CAPOZIDE 25/25, CAPTOPRIL CAPOZIDE 50/15, CAPTOPRIL CAPOZIDE 50/25, CAPTOPRIL KENALOG, TRIAMCINOLONE ACETONIDE KENALOG-10, TRIAMCINOLONE ACETONIDE KENALOG-40, TRIAMCINOLONE ACETONIDE KLOTRIX, POTASSIUM CHLORIDE OPHTHAINE, PROPARACAINE HYDROCHLORIDE STADOL PRESERVATIVE FREE, BUTORPHANOL TARTRATE
STADOL, BUTORPHANOL TARTRATE

TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE
APP PHARMS * APP PHARMACEUTICALS GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE, GRANISETRON HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM
PROTAMINE SULFATE, PROTAMINE SULFATE

* APP PHARMACEUTICALS LLC ACYCLOVIR SODIUM, ACYCLOVIR SODIUM ADENOSINE, ADENOSINE AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE ASTRAMORPH PF, MORPHINE SULFATE AZITHROMYCIN, AZITHROMYCIN AZTREONAM, AZTREONAM BACITRACIN, BACITRACIN BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE BLEOMYCIN SULFATE, BLEOMYCIN SULFATE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

B - 16

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** A **

* APP PHARMACEUTICALS LLC CAFFEINE CITRATE, CAFFEINE CITRATE CALCITRIOL, CALCITRIOL CARBOPLATIN, CARBOPLATIN CEFAZOLIN SODIUM, CEFAZOLIN SODIUM CEFOTAXIME, CEFOTAXIME SODIUM CEFOXITIN, CEFOXITIN SODIUM CEFTRIAXONE, CEFTRIAXONE SODIUM CEFUROXIME SODIUM, CEFUROXIME SODIUM CHLORAMPHENICOL SODIUM SUCCINATE, CHLORAMPHENICOL SODIUM SUCCINATE CHLOROTHIAZIDE SODIUM, CHLOROTHIAZIDE SODIUM CHORIONIC GONADOTROPIN, GONADOTROPIN, CHORIONIC CISPLATIN, CISPLATIN CLADRIBINE, CLADRIBINE CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE COLISTIMETHATE SODIUM, COLISTIMETHATE SODIUM CYTARABINE, CYTARABINE DACARBAZINE, DACARBAZINE DAUNORUBICIN HYDROCHLORIDE, DAUNORUBICIN HYDROCHLORIDE DEFEROXAMINE MESYLATE, DEFEROXAMINE MESYLATE DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE DIMENHYDRINATE, DIMENHYDRINATE DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE DIPRIVAN, PROPOFOL DIPYRIDAMOLE, DIPYRIDAMOLE DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE DOXY 100, DOXYCYCLINE HYCLATE DOXY 200, DOXYCYCLINE HYCLATE EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE ESMOLOL HYDROCHLORIDE, ESMOLOL HYDROCHLORIDE ETOPOSIDE, ETOPOSIDE FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE FAMOTIDINE, FAMOTIDINE FLOXURIDINE, FLOXURIDINE FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE FLUMAZENIL, FLUMAZENIL FLUOROURACIL, FLUOROURACIL FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE FOLIC ACID, FOLIC ACID FUROSEMIDE, FUROSEMIDE GANCICLOVIR, GANCICLOVIR SODIUM GENTAMICIN SULFATE, GENTAMICIN SULFATE GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE HALOPERIDOL, HALOPERIDOL LACTATE HEPARIN SODIUM IN PLASTIC CONTAINER, HEPARIN SODIUM HEPARIN SODIUM PRESERVATIVE FREE, HEPARIN SODIUM HEPARIN SODIUM, HEPARIN SODIUM HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE IDARUBICIN HYDROCHLORIDE, IDARUBICIN HYDROCHLORIDE IFOSFAMIDE, IFOSFAMIDE INDOMETHACIN, INDOMETHACIN IOPAMIDOL-250, IOPAMIDOL IOPAMIDOL-300, IOPAMIDOL IOPAMIDOL-370, IOPAMIDOL KANAMYCIN SULFATE, KANAMYCIN SULFATE KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE LEUCOVORIN CALCIUM PRESERVATIVE FREE, LEUCOVORIN CALCIUM LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE
MANNITOL 25%, MANNITOL

MESNA, MESNA

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

B - 17

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** A **

* APP PHARMACEUTICALS LLC METARAMINOL BITARTRATE, METARAMINOL BITARTRATE METHOTREXATE SODIUM, METHOTREXATE SODIUM METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE SODIUM SUCCINATE METOPROLOL TARTRATE, METOPROLOL TARTRATE MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE MILRINONE LACTATE, MILRINONE LACTATE MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE NAROPIN, ROPIVACAINE HYDROCHLORIDE MONOHYDRATE NEBUPENT, PENTAMIDINE ISETHIONATE NESACAINE, CHLOROPROCAINE HYDROCHLORIDE NESACAINE-MPF, CHLOROPROCAINE HYDROCHLORIDE OCTREOTIDE ACETATE (PRESERVATIVE FREE), OCTREOTIDE ACETATE OCTREOTIDE ACETATE, OCTREOTIDE ACETATE ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE OXALIPLATIN, OXALIPLATIN OXYTOCIN, OXYTOCIN PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM PENICILLIN G POTASSIUM, PENICILLIN G POTASSIUM PENTAM, PENTAMIDINE ISETHIONATE POLOCAINE, MEPIVACAINE HYDROCHLORIDE POLOCAINE-MPF, MEPIVACAINE HYDROCHLORIDE POLYMYXIN B SULFATE, POLYMYXIN B SULFATE POTASSIUM CHLORIDE IN PLASTIC CONTAINER, POTASSIUM CHLORIDE POTASSIUM CHLORIDE, POTASSIUM CHLORIDE PROGESTERONE, PROGESTERONE PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE PYRIDOXINE HYDROCHLORIDE, PYRIDOXINE HYDROCHLORIDE ROCURONIUM BROMIDE, ROCURONIUM BROMIDE SENSORCAINE, BUPIVACAINE HYDROCHLORIDE SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE TERBUTALINE SULFATE, TERBUTALINE SULFATE THIAMINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE TOBRAMYCIN SULFATE (PHARMACY BULK), TOBRAMYCIN SULFATE TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE VALPROATE SODIUM, VALPROATE SODIUM VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE VIBISONE, CYANOCOBALAMIN VINBLASTINE SULFATE, VINBLASTINE SULFATE VINORELBINE TARTRATE, VINORELBINE TARTRATE XYLOCAINE 4% PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE XYLOCAINE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE XYLOCAINE VISCOUS, LIDOCAINE HYDROCHLORIDE
XYLOCAINE W/ EPINEPHRINE, EPINEPHRINE

XYLOCAINE, LIDOCAINE HYDROCHLORIDE
* APP PHARMACEUTICALS, LLC--A CO. OF THE FRESENIUS KABI GROUP ACYCLOVIR SODIUM, ACYCLOVIR SODIUM CEFOTETAN, CEFOTETAN DISODIUM CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE FLUPHENAZINE DECANOATE, FLUPHENAZINE DECANOATE
FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM

GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE
APTALIS PHARMA US * APTALIS PHARMA US INC BENTYL PRESERVATIVE FREE, DICYCLOMINE HYDROCHLORIDE BENTYL, DICYCLOMINE HYDROCHLORIDE CARAFATE, SUCRALFATE PYLERA, BISMUTH SUBCITRATE POTASSIUM
URSO 250, URSODIOL

URSO FORTE, URSODIOL

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

B - 18

APPENDIX B
* APTALIS PHARMA US INC ZENPEP, LIPASE AQUA PHARMS * AQUA PHARMACEUTICALS LLC SOLAGE, MEQUINOL

XOLEGEL, KETOCONAZOLE

PRODUCT NAME SORTED BY APPLICANT

** A **

AR HOLDING CO INC * AR HOLDING CO INC COLCRYS, COLCHICINE

FIBRICOR, FENOFIBRIC ACID
QUALAQUIN, QUININE SULFATE

ARBOR PHARMS INC * ARBOR PHARMACEUTICALS INC BIDIL, HYDRALAZINE HYDROCHLORIDE E.E.S. 200, ERYTHROMYCIN ETHYLSUCCINATE E.E.S. 400, ERYTHROMYCIN ETHYLSUCCINATE

E.E.S., ERYTHROMYCIN ETHYLSUCCINATE

ERYPED, ERYTHROMYCIN ETHYLSUCCINATE

ERY-TAB, ERYTHROMYCIN

ERYTHROCIN STEARATE, ERYTHROMYCIN STEARATE

ERYTHROMYCIN ETHYLSUCCINATE, ERYTHROMYCIN ETHYLSUCCINATE

ERYTHROMYCIN, ERYTHROMYCIN

PCE, ERYTHROMYCIN


PEDIAMYCIN 400, ERYTHROMYCIN ETHYLSUCCINATE
PEDIAMYCIN, ERYTHROMYCIN ETHYLSUCCINATE

ARCHIMEDES * ARCHIMEDES DEVELOPMENT LTD LAZANDA, FENTANYL CITRATE AREVA PHARMS * AREVA PHARMACEUTICALS INC PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM ARMSTRONG PHARMS * ARMSTRONG PHARMACEUTICALS INC EPINEPHRINE, EPINEPHRINE (OTC) ASCEND * ASCEND THERAPEUTICS INC ESTROGEL, ESTRADIOL ASPEN GLOBAL * ASPEN GLOBAL INC MYLERAN, BUSULFAN ASTELLAS * ASTELLAS PHARMA US INC ADENOCARD, ADENOSINE ADENOSCAN, ADENOSINE AMBISOME, AMPHOTERICIN B LEXISCAN, REGADENOSON MYCAMINE, MICAFUNGIN SODIUM PROGRAF, TACROLIMUS PROTOPIC, TACROLIMUS VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER, VESICARE, SOLIFENACIN SUCCINATE ASTRAZENECA * ASTRAZENECA LP ENTOCORT EC, BUDESONIDE NEXIUM IV, ESOMEPRAZOLE SODIUM NEXIUM, ESOMEPRAZOLE MAGNESIUM PRILOSEC OTC, OMEPRAZOLE MAGNESIUM PRILOSEC, OMEPRAZOLE
PRILOSEC, OMEPRAZOLE MAGNESIUM

PULMICORT FLEXHALER, BUDESONIDE

CONIVAPTAN HYDROCHLORIDE

(OTC)

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

B - 19

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** A **

* ASTRAZENECA LP PULMICORT RESPULES, BUDESONIDE RHINOCORT, BUDESONIDE SEROQUEL, QUETIAPINE FUMARATE SYMBICORT, BUDESONIDE TENORMIN, ATENOLOL

TOPROL-XL, METOPROLOL SUCCINATE

* ASTRAZENECA PHARMACEUTICALS LP ATACAND HCT, CANDESARTAN CILEXETIL ATACAND, CANDESARTAN CILEXETIL FASLODEX, FULVESTRANT PLENDIL, FELODIPINE PULMICORT, BUDESONIDE SEROQUEL XR, QUETIAPINE FUMARATE TENORETIC 100, ATENOLOL TENORETIC 50, ATENOLOL ZOMIG, ZOLMITRIPTAN

ZOMIG-ZMT, ZOLMITRIPTAN

* ASTRAZENECA UK LTD ACCOLATE, ZAFIRLUKAST ARIMIDEX, ANASTROZOLE CASODEX, BICALUTAMIDE MERREM, MEROPENEM ZESTORETIC, HYDROCHLOROTHIAZIDE ZESTRIL, LISINOPRIL

ZOLADEX, GOSERELIN ACETATE

ASTRAZENECA LP * ASTRAZENECA LP BRILINTA, TICAGRELOR

VIMOVO, ESOMEPRAZOLE MAGNESIUM

ATON * ATON PHARMA INC CUPRIMINE, PENICILLAMINE DEMSER, METYROSINE EDECRIN, ETHACRYNATE SODIUM EDECRIN, ETHACRYNIC ACID LACRISERT, HYDROXYPROPYL CELLULOSE LODOSYN, CARBIDOPA SYPRINE, TRIENTINE HYDROCHLORIDE TIMOPTIC IN OCUDOSE, TIMOLOL MALEATE
TIMOPTIC, TIMOLOL MALEATE

TIMOPTIC-XE, TIMOLOL MALEATE
AUROBINDO * AUROBINDO PHARMA LTD AMOXICILLIN, AMOXICILLIN CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LISINOPRIL, LISINOPRIL METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
MIRTAZAPINE, MIRTAZAPINE

ZIDOVUDINE, ZIDOVUDINE
AUROBINDO PHARM * AUROBINDO PHARMA USA INC ATOMOXETINE HYDROCHLORIDE, ATOMOXETINE HYDROCHLORIDE FLUCONAZOLE, FLUCONAZOLE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE GABAPENTIN, GABAPENTIN LEVETIRACETAM, LEVETIRACETAM
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

B - 20

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** A **

AUROBINDO PHARMA * AUROBINDO PHARMA AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM * AUROBINDO PHARMA LTD ALENDRONATE SODIUM, ALENDRONATE SODIUM AMLODIPINE BESYLATE, AMLODIPINE BESYLATE AMOXICILLIN, AMOXICILLIN AMPICILLIN SODIUM, AMPICILLIN SODIUM ATENOLOL, ATENOLOL BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE BISOPROLOL FUMARATE, BISOPROLOL FUMARATE CARISOPRODOL, CARISOPRODOL CARVEDILOL, CARVEDILOL CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE CEFAZOLIN SODIUM, CEFAZOLIN SODIUM CEFDINIR, CEFDINIR CEFOTAXIME SODIUM, CEFOTAXIME SODIUM CEFPODOXIME PROXETIL, CEFPODOXIME PROXETIL CEFPROZIL, CEFPROZIL CEFTAZIDIME, CEFTAZIDIME CEFTRIAXONE, CEFTRIAXONE SODIUM CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE DIDANOSINE, DIDANOSINE FINASTERIDE, FINASTERIDE FLUCONAZOLE, FLUCONAZOLE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE GLYBURIDE, GLYBURIDE HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LAMOTRIGINE, LAMOTRIGINE LEVETIRACETAM, LEVETIRACETAM LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM, LOSARTAN POTASSIUM MELOXICAM, MELOXICAM METOPROLOL TARTRATE, METOPROLOL TARTRATE MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE ONDANSETRON, ONDANSETRON PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE PENICILLIN V POTASSIUM, PENICILLIN V POTASSIUM PERINDOPRIL ERBUMINE, PERINDOPRIL ERBUMINE QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE RIBAVARIN, RIBAVIRIN RIBAVIRIN, RIBAVIRIN RISPERIDONE, RISPERIDONE SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE SIMVASTATIN, SIMVASTATIN STAVUDINE, STAVUDINE SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE TOPIRAMATE, TOPIRAMATE TORSEMIDE, TORSEMIDE TRANDOLAPRIL, TRANDOLAPRIL VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

ZALEPLON, ZALEPLON

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

B - 21

APPENDIX B
* AUROBINDO PHARMA LTD ZOLPIDEM TARTRATE,

PRODUCT NAME SORTED BY APPLICANT

** A **

ZOLPIDEM TARTRATE

AUROBINDO PHARMA LTD * AUROBINDO PHARMA LIMITED DIVALPROEX SODIUM, DIVALPROEX SODIUM FOSINOPRIL SODIUM, FOSINOPRIL SODIUM GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE LEVOFLOXACIN, LEVOFLOXACIN

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

* AUROBINDO PHARMA LTD AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN FAMCICLOVIR, FAMCICLOVIR GABAPENTIN, GABAPENTIN LAMIVUDINE, LAMIVUDINE NAPROXEN SODIUM, NAPROXEN SODIUM PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM

RAMIPRIL, RAMIPRIL

* AUROBINDO PHARMA LTD INC CEFPROZIL, CEFPROZIL CEFUROXIME AXETIL, CEFUROXIME AXETIL CEPHALEXIN, CEPHALEXIN CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE MIRTAZAPINE, MIRTAZAPINE

ZIDOVUDINE, ZIDOVUDINE

AUROBINDO PHARMA USA * AUROBINDO PHARMA USA INC ALPRAZOLAM, ALPRAZOLAM

NAPROXEN, NAPROXEN

AUROSAL PHARMS * AUROSAL PHARMACEUTICALS LLC AMIODARONE HYDROCHLORIDE,

AMIODARONE HYDROCHLORIDE

AUSTARPHARMA LLC * AUSTARPHARMA LLC ALENDRONATE SODIUM, ALENDRONATE SODIUM

METHOCARBAMOL, METHOCARBAMOL

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
AUXILIUM PHARMS * AUXILIUM PHARMACEUTICALS TESTIM, TESTOSTERONE AVACOR PRODS * AVACOR PRODUCTS LLC MINOXIDIL EXTRA STRENGTH (FOR MEN),

MINOXIDIL

(OTC)

AVANIR PHARMS * AVANIR PHARMACEUTICALS INC NUEDEXTA, DEXTROMETHORPHAN HYDROBROMIDE AVANTHI INC * AVANTHI INC CHLORPHENIRAMINE MALEATE, CHLORPHENIRAMINE MALEATE (OTC) DIETHYLPROPION HYDROCHLORIDE, DIETHYLPROPION HYDROCHLORIDE
INDOMETHACIN, INDOMETHACIN

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
AVEMA PHARMA * AVEMA PHARMA SOLUTIONS IBUPROFEN, IBUPROFEN

(OTC)

AVENT * AVENT INC

PYTEST KIT, UREA, C-14

PYTEST, UREA, C-14

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** A **

AVEVA * AVEVA DRUG DELIVERY SYSTEMS INC

CLONIDINE, CLONIDINE

NICOTINE, NICOTINE (OTC)
AXCAN * AXCAN PHARMA US INC CANASA, MESALAMINE AZTIQ PHARMA * AZTIQ PHARMA INC TODAY, NONOXYNOL-9

(OTC)

AZUR PHARMA * AZUR PHARMA INTERNATIONAL LTD

AVC, SULFANILAMIDE

GASTROCROM, CROMOLYN SODIUM
AZUR PHARMA II * AZUR PHARMA INTERNATIONAL II LTD
ELESTRIN, ESTRADIOL

PRIALT, ZICONOTIDE ACETATE
AZUR PHARMA INTL * AZUR PHARMA INTERNATIONAL III LTD FAZACLO ODT, CLOZAPINE B BRAUN * B BRAUN MEDICAL INC ACETIC ACID 0.25% IN PLASTIC CONTAINER, ACETIC ACID, GLACIAL ALCOHOL 10% AND DEXTROSE 5%, ALCOHOL ALCOHOL 5% AND DEXTROSE 5%, ALCOHOL BALANCED SALT, CALCIUM CHLORIDE BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER, BRETYLIUM TOSYLATE CEFAZOLIN AND DEXTROSE, CEFAZOLIN SODIUM CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER, CEFEPIME HYDROCHLORIDE CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER, CEFOTETAN DISODIUM CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER, CEFOXITIN SODIUM CEFTAZIDIME IN DEXTROSE CONTAINER, CEFTAZIDIME CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER, CEFTRIAXONE SODIUM CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER, CEFUROXIME SODIUM DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 10% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% IN ACETATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% IN RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

B - 23

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** B **

* B BRAUN MEDICAL INC DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER, DOPAMINE HYDROCHLORIDE DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%, DOPAMINE HYDROCHLORIDE FREAMINE HBC 6.9%, AMINO ACIDS FREAMINE III 10%, AMINO ACIDS FREAMINE III 3% W/ ELECTROLYTES, AMINO ACIDS FREAMINE III 8.5% W/ ELECTROLYTES, AMINO ACIDS FREAMINE III 8.5%, AMINO ACIDS GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, GENTAMICIN SULFATE GLYCINE 1.5% IN PLASTIC CONTAINER, GLYCINE HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN SODIUM HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM HEPATAMINE 8%, AMINO ACIDS ISOLYTE E IN DEXTROSE 5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE ISOLYTE E IN PLASTIC CONTAINER, CALCIUM CHLORIDE ISOLYTE H IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE ISOLYTE M IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE ISOLYTE P IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE ISOLYTE R IN DEXTROSE 5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE ISOLYTE S IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE ISOLYTE S IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE ISOLYTE S PH 7.4 IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE MANNITOL 10% IN PLASTIC CONTAINER, MANNITOL MANNITOL 10% W/ DEXTROSE 5% IN DISTILLED WATER, MANNITOL MANNITOL 10%, MANNITOL MANNITOL 15% IN PLASTIC CONTAINER, MANNITOL MANNITOL 15% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.45%, MANNITOL MANNITOL 15%, MANNITOL MANNITOL 20% IN PLASTIC CONTAINER, MANNITOL MANNITOL 20%, MANNITOL MANNITOL 5% IN PLASTIC CONTAINER, MANNITOL MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12%, MANNITOL MANNITOL 5%, MANNITOL METRO I.V. IN PLASTIC CONTAINER, METRONIDAZOLE MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MILRINONE LACTATE NEPHRAMINE 5.4%, AMINO ACIDS NUTRILIPID 10%, SOYBEAN OIL NUTRILIPID 20%, SOYBEAN OIL PHYSIOLYTE IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

B - 24

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** B **

* B BRAUN MEDICAL INC POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC
CONTAINER, DEXTROSE

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.11% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.15% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.22% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

B - 25

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** B **

* B BRAUN MEDICAL INC POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.3% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE, POTASSIUM CHLORIDE PROCALAMINE, AMINO ACIDS RESECTISOL IN PLASTIC CONTAINER, MANNITOL RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, SODIUM CHLORIDE SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE SODIUM LACTATE 1/6 MOLAR IN PLASTIC CONTAINER, SODIUM LACTATE SORBITOL 3.3% IN PLASTIC CONTAINER, SORBITOL STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION STERILE WATER IN PLASTIC CONTAINER, STERILE WATER FOR IRRIGATION THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE THEOPHYLLINE 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE TROPHAMINE 10%, AMINO ACIDS TROPHAMINE, AMINO ACIDS BANNER PHARMACAPS * BANNER PHARMACAPS INC AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE BENZONATATE, BENZONATATE CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) ETHOSUXIMIDE, ETHOSUXIMIDE IBUPROFEN AND DIPHENHYDRAMINE, DIPHENHYDRAMINE HYDROCHLORIDE (OTC) IBUPROFEN, IBUPROFEN (OTC) LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC) MIDOL LIQUID GELS, IBUPROFEN (OTC) NAPROXEN SODIUM, NAPROXEN SODIUM (OTC) NIMODIPINE, NIMODIPINE STAVZOR, VALPROIC ACID VALPROIC ACID, VALPROIC ACID
VITAMIN D, ERGOCALCIFEROL

ZONISAMIDE, ZONISAMIDE
BARR * BARR LABORATORIES INC ALPRAZOLAM, ALPRAZOLAM AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, AMILORIDE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE
ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE

ARANELLE, ETHINYL ESTRADIOL

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

B - 26

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** B **

* BARR LABORATORIES INC ASPIRIN AND DIPYRIDAMOLE, ASPIRIN BALZIVA-28, ETHINYL ESTRADIOL BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE CAMILA, NORETHINDRONE CHLORDIAZEPOXIDE HYDROCHLORIDE, CHLORDIAZEPOXIDE HYDROCHLORIDE CHLORZOXAZONE, CHLORZOXAZONE CLARAVIS, ISOTRETINOIN CLONAZEPAM, CLONAZEPAM CLONIDINE, CLONIDINE DANAZOL, DANAZOL DEMECLOCYCLINE HYDROCHLORIDE, DEMECLOCYCLINE HYDROCHLORIDE DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE ASPARTATE DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE DIAZEPAM, DIAZEPAM DIDANOSINE, DIDANOSINE DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE DIPYRIDAMOLE, DIPYRIDAMOLE DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE DUTASTERIDE, DUTASTERIDE ERRIN, NORETHINDRONE ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL, ERYTHROMYCIN ETHYLSUCCINATE ESTRADIOL AND NORETHINDRONE ACETATE, ESTRADIOL ESTRADIOL AND NORGESTIMATE, ESTRADIOL ESTRADIOL, ESTRADIOL ESTROPIPATE, ESTROPIPATE ETHAMBUTOL HYDROCHLORIDE, ETHAMBUTOL HYDROCHLORIDE FENTANYL CITRATE, FENTANYL CITRATE FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE FLECAINIDE ACETATE, FLECAINIDE ACETATE FLUDROCORTISONE ACETATE, FLUDROCORTISONE ACETATE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE HYDROXYUREA, HYDROXYUREA HYDROXYZINE PAMOATE, HYDROXYZINE PAMOATE ISONIAZID, ISONIAZID JUNEL 1.5/30, ETHINYL ESTRADIOL JUNEL 1/20, ETHINYL ESTRADIOL JUNEL FE 1.5/30, ETHINYL ESTRADIOL JUNEL FE 1/20, ETHINYL ESTRADIOL KARIVA, DESOGESTREL KELNOR, ETHINYL ESTRADIOL LEFLUNOMIDE, LEFLUNOMIDE LESSINA-28, ETHINYL ESTRADIOL MEDROXYPROGESTERONE ACETATE, MEDROXYPROGESTERONE ACETATE MEFLOQUINE HYDROCHLORIDE, MEFLOQUINE HYDROCHLORIDE MEGESTROL ACETATE, MEGESTROL ACETATE MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE METHOTREXATE SODIUM, METHOTREXATE SODIUM MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL NORETHINDRONE ACETATE, NORETHINDRONE ACETATE NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL NORTREL 0.5/35-28, ETHINYL ESTRADIOL NORTREL 1/35-21, ETHINYL ESTRADIOL NORTREL 1/35-28, ETHINYL ESTRADIOL

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

B - 27

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** B **

* BARR LABORATORIES INC NORTREL 7/7/7, ETHINYL ESTRADIOL ONDANSETRON, ONDANSETRON PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE PORTIA-28, ETHINYL ESTRADIOL PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE SPRINTEC, ETHINYL ESTRADIOL TEMOZOLOMIDE, TEMOZOLOMIDE TRETINOIN, TRETINOIN TREXALL, METHOTREXATE SODIUM TRI LO SPRINTEC, ETHINYL ESTRADIOL TRI-LEGEST 21, ETHINYL ESTRADIOL TRI-LEGEST FE, ETHINYL ESTRADIOL TRI-SPRINTEC, ETHINYL ESTRADIOL WARFARIN SODIUM, WARFARIN SODIUM

ZONISAMIDE, ZONISAMIDE

* BARR PHARMACEUTICALS LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM BARR LABS INC * BARR LABORATORIES INC NIMODIPINE, NIMODIPINE

OXYCODONE HYDROCHLORIDE AND IBUPROFEN,

IBUPROFEN

BAUSCH AND LOMB * BAUSCH AND LOMB INC ALAWAY, KETOTIFEN FUMARATE (OTC) ALBUTEROL SULFATE, ALBUTEROL SULFATE ALREX, LOTEPREDNOL ETABONATE BESIVANCE, BESIFLOXACIN HYDROCHLORIDE CARTEOLOL HYDROCHLORIDE, CARTEOLOL HYDROCHLORIDE DICLOFENAC SODIUM, DICLOFENAC SODIUM DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE FLURBIPROFEN SODIUM, FLURBIPROFEN SODIUM IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE LATANOPROST, LATANOPROST LOTEMAX, LOTEPREDNOL ETABONATE MIOCHOL-E, ACETYLCHOLINE CHLORIDE OFLOXACIN, OFLOXACIN OPCON-A, NAPHAZOLINE HYDROCHLORIDE (OTC) RETISERT, FLUOCINOLONE ACETONIDE TIMOLOL MALEATE, TIMOLOL MALEATE VITRASERT, GANCICLOVIR
ZIRGAN, GANCICLOVIR

ZYLET, LOTEPREDNOL ETABONATE
* BAUSCH AND LOMB PHARMACEUTICALS INC ACETIC ACID 2% IN AQUEOUS ALUMINUM ACETATE, ACETIC ACID, GLACIAL BACITRACIN ZINC AND POLYMYXIN B SULFATE, BACITRACIN ZINC BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE CROLOM, CROMOLYN SODIUM CROMOLYN SODIUM, CROMOLYN SODIUM CROMOLYN SODIUM, CROMOLYN SODIUM (OTC) DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE DEXASPORIN, DEXAMETHASONE ERYTHROMYCIN, ERYTHROMYCIN FLUNISOLIDE, FLUNISOLIDE GENTAMICIN SULFATE, GENTAMICIN SULFATE IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE LEVOBUNOLOL HYDROCHLORIDE, LEVOBUNOLOL HYDROCHLORIDE NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC, BACITRACIN ZINC NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE, DEXAMETHASONE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

B - 28

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** B **

* BAUSCH AND LOMB PHARMACEUTICALS INC NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN, GRAMICIDIN NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE, HYDROCORTISONE NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE, BACITRACIN ZINC OFLOXACIN, OFLOXACIN OPTIPRANOLOL, METIPRANOLOL HYDROCHLORIDE OTICAIR, HYDROCORTISONE PENTOLAIR, CYCLOPENTOLATE HYDROCHLORIDE PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE PROPARACAINE HYDROCHLORIDE, PROPARACAINE HYDROCHLORIDE SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM TIMOLOL MALEATE, TIMOLOL MALEATE TOBRAMYCIN AND DEXAMETHASONE, DEXAMETHASONE TOBRAMYCIN, TOBRAMYCIN TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE, POLYMYXIN B SULFATE

TROPICAMIDE, TROPICAMIDE

BAXTER HLTHCARE * BAXTER HEALTHCARE CORP ACETIC ACID 0.25% IN PLASTIC CONTAINER, ACETIC ACID, GLACIAL ADENOSINE, ADENOSINE AMINOACETIC ACID 1.5% IN PLASTIC CONTAINER, GLYCINE ANCEF IN PLASTIC CONTAINER, CEFAZOLIN SODIUM BACTOCILL IN PLASTIC CONTAINER, OXACILLIN SODIUM BRANCHAMIN 4% IN PLASTIC CONTAINER, AMINO ACIDS CARDIOPLEGIC IN PLASTIC CONTAINER, CALCIUM CHLORIDE CEFEPIME IN PLASTIC CONTAINER, CEFEPIME HYDROCHLORIDE CEFTRIAXONE IN PLASTIC CONTAINER, CEFTRIAXONE SODIUM CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN CLINIMIX 2.75/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX 2.75/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX 2.75/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX 4.25/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX 4.25/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX 4.25/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX 4.25/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX 5/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX 5/15 SULFITE FREE IN DEXTROSE 15% IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX 5/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX 5/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX 5/35 SULFITE FREE IN DEXTROSE 35% IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX E 2.75/10 SULFITE-FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX E 2.75/25 SULFITE-FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX E 2.75/5 SULFITE-FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX E 4.25/10 SULFITE-FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX E 4.25/20 SULFITE-FREE W/ ELECT IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX E 4.25/25 SULFITE-FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX E 4.25/5 SULFITE-FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX E 5/10 SULFITE-FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX E 5/15 SULFITE-FREE W/ ELECT IN DEXTROSE 15% W/ CALCIUM IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX E 5/20 SULFITE-FREE W/ ELECT IN 20% DEXTROSE W/ CALCIUM IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX E 5/25 SULFITE-FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX E 5/35 SULFITE-FREE W/ ELECT IN DEXTROSE 35% W/ CALCIUM IN PLASTIC CONTAINER, AMINO ACIDS CYTOXAN, CYCLOPHOSPHAMIDE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

B - 29

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** B **

* BAXTER HEALTHCARE CORP DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 10% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 20% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 30% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 40% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% AND ELECTROLYTE NO 75 IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% AND ELECTROLYTE NO.48 IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% IN RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE DEXTROSE 5% IN SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% IN SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ, DEXTROSE DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K), DEXTROSE DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ (K), DEXTROSE DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ, DEXTROSE DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 30MEQ, DEXTROSE DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 40MEQ, DEXTROSE DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (K), DEXTROSE DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ, DEXTROSE DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 50% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 60% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 70% IN PLASTIC CONTAINER, DEXTROSE DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIANEAL LOW CALCIUM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIANEAL LOW CALCIUM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIANEAL PD-1 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIANEAL PD-1 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIANEAL PD-1 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIANEAL PD-2 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOBUTAMINE HYDROCHLORIDE DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOPAMINE HYDROCHLORIDE EXTRANEAL, ICODEXTRIN FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE FAMOTIDINE, FAMOTIDINE FLAGYL I.V. RTU IN PLASTIC CONTAINER, METRONIDAZOLE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

B - 30

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** B **

* BAXTER HEALTHCARE CORP FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN SODIUM HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN SODIUM HEPARIN SODIUM 20,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM HEPARIN SODIUM 25,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM HEPATASOL 8%, AMINO ACIDS IFEX, IFOSFAMIDE ISOTONIC GENTAMICIN SULFATE IN PLASTIC CONTAINER, GENTAMICIN SULFATE LACTATED RINGER'S AND DEXTROSE 5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE MESNEX, MESNA MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MILRINONE LACTATE NALLPEN IN PLASTIC CONTAINER, NAFCILLIN SODIUM NEXTERONE, AMIODARONE HYDROCHLORIDE NITROGLYCERIN IN DEXTROSE 5%, NITROGLYCERIN ONDANSETRON HYDROCHLORIDE AND SODIUM CHLORIDE IN PLASTIC CONTAINER, ONDANSETRON HYDROCHLORIDE OSMITROL 10% IN WATER IN PLASTIC CONTAINER, MANNITOL OSMITROL 10% IN WATER, MANNITOL OSMITROL 15% IN WATER IN PLASTIC CONTAINER, MANNITOL OSMITROL 15% IN WATER, MANNITOL OSMITROL 20% IN WATER IN PLASTIC CONTAINER, MANNITOL OSMITROL 20% IN WATER, MANNITOL OSMITROL 5% IN WATER IN PLASTIC CONTAINER, MANNITOL OSMITROL 5% IN WATER, MANNITOL PENICILLIN G POTASSIUM IN PLASTIC CONTAINER, PENICILLIN G POTASSIUM PHENYTOIN SODIUM, PHENYTOIN SODIUM PLASMA-LYTE 148 AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE PLASMA-LYTE 56 AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE PLASMA-LYTE 56 IN PLASTIC CONTAINER, MAGNESIUM ACETATE TETRAHYDRATE PLASMA-LYTE A IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE PLASMA-LYTE M AND DEXTROSE 5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE PLASMA-LYTE R IN PLASTIC CONTAINER, CALCIUM CHLORIDE POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE POTASSIUM CHLORIDE 0.224% IN SODIUM CHLORIDE 0.9%, POTASSIUM CHLORIDE POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

B - 31

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** B **

* BAXTER HEALTHCARE CORP POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,
CALCIUM CHLORIDE

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
DEXTROSE

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
DEXTROSE

POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,
CALCIUM CHLORIDE

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
DEXTROSE

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
DEXTROSE POTASSIUM CHLORIDE, POTASSIUM CHLORIDE PREMASOL 10% IN PLASTIC CONTAINER, AMINO ACIDS PREMASOL 6% IN PLASTIC CONTAINER, AMINO ACIDS RENAMIN W/O ELECTROLYTES, AMINO ACIDS RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE SEVOFLURANE, SEVOFLURANE SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, SODIUM CHLORIDE SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER, SODIUM CHLORIDE SODIUM CHLORIDE 3% IN PLASTIC CONTAINER, SODIUM CHLORIDE SODIUM CHLORIDE 5% IN PLASTIC CONTAINER, SODIUM CHLORIDE SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER, SODIUM LACTATE SORBITOL 3% IN PLASTIC CONTAINER, SORBITOL STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION STERILE WATER IN PLASTIC CONTAINER, STERILE WATER FOR IRRIGATION STERILE WATER, STERILE WATER FOR IRRIGATION THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE TIS-U-SOL IN PLASTIC CONTAINER, MAGNESIUM SULFATE TIS-U-SOL, MAGNESIUM SULFATE TRAVASOL 10% IN PLASTIC CONTAINER, AMINO ACIDS TRAVASOL 10% W/O ELECTROLYTES, AMINO ACIDS TRAVASOL 3.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER, AMINO ACIDS TRAVASOL 3.5% W/ ELECTROLYTES, AMINO ACIDS TRAVASOL 5.5% IN PLASTIC CONTAINER, AMINO ACIDS TRAVASOL 5.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER, AMINO ACIDS TRAVASOL 5.5% W/ ELECTROLYTES, AMINO ACIDS TRAVASOL 5.5% W/O ELECTROLYTES, AMINO ACIDS TRAVASOL 8.5% IN PLASTIC CONTAINER, AMINO ACIDS TRAVASOL 8.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER, AMINO ACIDS TRAVASOL 8.5% W/ ELECTROLYTES, AMINO ACIDS TRAVASOL 8.5% W/O ELECTROLYTES, AMINO ACIDS VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER, VANCOMYCIN HYDROCHLORIDE * BAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE, ACYCLOVIR SODIUM ACYCLOVIR SODIUM, ACYCLOVIR SODIUM AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM BUMETANIDE, BUMETANIDE CEFOXITIN, CEFOXITIN SODIUM CHLORPROMAZINE HYDROCHLORIDE, CHLORPROMAZINE HYDROCHLORIDE CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE DIGOXIN, DIGOXIN DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE DIPYRIDAMOLE, DIPYRIDAMOLE
DOPRAM, DOXAPRAM HYDROCHLORIDE

DURAMORPH PF, MORPHINE SULFATE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

B - 32

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** B **

* BAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE FAMOTIDINE, FAMOTIDINE FENTANYL CITRATE PRESERVATIVE FREE, FENTANYL CITRATE FLUMAZENIL, FLUMAZENIL FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE HEPARIN SODIUM, HEPARIN SODIUM INFUMORPH, MORPHINE SULFATE KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE MILRINONE LACTATE, MILRINONE LACTATE MITOMYCIN, MITOMYCIN ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE PROCHLORPERAZINE EDISYLATE, PROCHLORPERAZINE EDISYLATE PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE ROBINUL, GLYCOPYRROLATE SUFENTANIL CITRATE, SUFENTANIL CITRATE TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE

VINORELBINE TARTRATE, VINORELBINE TARTRATE

* BAXTER HEALTHCARE INTERNATI0NAL SPECIALTY THERAPIES DIV FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER, FAMOTIDINE

PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER, AMINO ACIDS

BAXTER HLTHCARE CORP * BAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE, MEPERIDINE HYDROCHLORIDE * BAXTER HEALTHCARE CORP ANESTHESIA CRITICAL CARE ATIVAN, LORAZEPAM BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER, ESMOLOL HYDROCHLORIDE BREVIBLOC IN PLASTIC CONTAINER, ESMOLOL HYDROCHLORIDE BREVIBLOC, ESMOLOL HYDROCHLORIDE ETHRANE, ENFLURANE FORANE, ISOFLURANE KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE OXYTOCIN, OXYTOCIN PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE PROTOPAM CHLORIDE, PRALIDOXIME CHLORIDE REGLAN, METOCLOPRAMIDE HYDROCHLORIDE
ROBAXIN, METHOCARBAMOL

SUPRANE, DESFLURANE
BAYER * BAYER HEALTHCARE LLC ALEVE, NAPROXEN SODIUM (OTC)
ALEVE-D SINUS & COLD, NAPROXEN SODIUM (OTC)

FEMSTAT 3, BUTOCONAZOLE NITRATE (OTC)
BAYER HLTHCARE * BAYER HEALTHCARE CONSUMER CARE RID MOUSSE, PIPERONYL BUTOXIDE (OTC) * BAYER HEALTHCARE PHARMACEUTICALS INC ADALAT CC, NIFEDIPINE ANGELIQ, DROSPIRENONE AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER, MOXIFLOXACIN HYDROCHLORIDE AVELOX, MOXIFLOXACIN HYDROCHLORIDE BETAPACE AF, SOTALOL HYDROCHLORIDE BETAPACE, SOTALOL HYDROCHLORIDE BEYAZ, DROSPIRENONE CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN CIPRO XR, CIPROFLOXACIN
CIPRO, CIPROFLOXACIN

CIPRO, CIPROFLOXACIN HYDROCHLORIDE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

B - 33

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** B **

* BAYER HEALTHCARE PHARMACEUTICALS INC CLIMARA PRO, ESTRADIOL CLIMARA, ESTRADIOL DTIC-DOME, DACARBAZINE EOVIST, GADOXETATE DISODIUM GADAVIST, GADOBUTROL LEVITRA, VARDENAFIL HYDROCHLORIDE MAGNEVIST, GADOPENTETATE DIMEGLUMINE MENOSTAR, ESTRADIOL MIRENA, LEVONORGESTREL MYCELEX, CLOTRIMAZOLE NATAZIA, ESTRADIOL VALERATE NEXAVAR, SORAFENIB TOSYLATE PRECOSE, ACARBOSE REFLUDAN, LEPIRUDIN RECOMBINANT SAFYRAL, DROSPIRENONE STAXYN, VARDENAFIL HYDROCHLORIDE TRASYLOL, APROTININ ULTRAVIST (PHARMACY BULK), IOPROMIDE ULTRAVIST 150, IOPROMIDE ULTRAVIST 240, IOPROMIDE ULTRAVIST 300 IN PLASTIC CONTAINER, IOPROMIDE ULTRAVIST 300, IOPROMIDE ULTRAVIST 370, IOPROMIDE YASMIN, DROSPIRENONE

YAZ, DROSPIRENONE

BAYER PHARMA AG * BAYER PHARMA AG BILTRICIDE, PRAZIQUANTEL BAYER PHARMS * BAYER PHARMACEUTICALS CORP MYCELEX-7 COMBINATION PACK, CLOTRIMAZOLE MYCELEX-7, CLOTRIMAZOLE (OTC)

(OTC)

BECTON DICKINSON * BECTON DICKINSON AND CO CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE E-Z SCRUB 201, POVIDONE-IODINE (OTC)

E-Z SCRUB 241, POVIDONE-IODINE (OTC)

(OTC)

BEDFORD * BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC ACETAZOLAMIDE SODIUM, ACETAZOLAMIDE SODIUM ACETYLCYSTEINE, ACETYLCYSTEINE ACYCLOVIR SODIUM, ACYCLOVIR SODIUM ADENOSINE, ADENOSINE ALPROSTADIL, ALPROSTADIL AMIKACIN SULFATE, AMIKACIN SULFATE AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE AMRINONE LACTATE, INAMRINONE LACTATE ATRACURIUM BESYLATE PRESERVATIVE FREE, ATRACURIUM BESYLATE ATRACURIUM BESYLATE, ATRACURIUM BESYLATE AZATHIOPRINE SODIUM, AZATHIOPRINE SODIUM AZTREONAM, AZTREONAM BLEOMYCIN SULFATE, BLEOMYCIN SULFATE BUMETANIDE, BUMETANIDE BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE BUTORPHANOL TARTRATE PRESERVATIVE FREE, BUTORPHANOL TARTRATE BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE CARBOPLATIN, CARBOPLATIN CEFTRIAXONE, CEFTRIAXONE SODIUM CERUBIDINE, DAUNORUBICIN HYDROCHLORIDE CHLOROPROCAINE HYDROCHLORIDE, CHLOROPROCAINE HYDROCHLORIDE

CISPLATIN, CISPLATIN

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** B **

* BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC CLADRIBINE, CLADRIBINE CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE CYCLOSPORINE, CYCLOSPORINE CYTARABINE, CYTARABINE DACARBAZINE, DACARBAZINE DACTINOMYCIN, DACTINOMYCIN DAUNORUBICIN HYDROCHLORIDE, DAUNORUBICIN HYDROCHLORIDE DEFEROXAMINE MESYLATE, DEFEROXAMINE MESYLATE DEXRAZOXANE HYDROCHLORIDE, DEXRAZOXANE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE-FREE), DICYCLOMINE HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE DIPYRIDAMOLE, DIPYRIDAMOLE DOBUTAMINE HYDROCHLORIDE, DOBUTAMINE HYDROCHLORIDE DOXAPRAM HYDROCHLORIDE, DOXAPRAM HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE DOXYCYCLINE, DOXYCYCLINE HYCLATE ENALAPRILAT, ENALAPRILAT EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE ETOMIDATE, ETOMIDATE ETOPOSIDE, ETOPOSIDE FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE FAMOTIDINE, FAMOTIDINE FLOXURIDINE, FLOXURIDINE FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE FLUPHENAZINE DECANOATE, FLUPHENAZINE DECANOATE FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE HALOPERIDOL, HALOPERIDOL LACTATE INDOMETHACIN SODIUM, INDOMETHACIN SODIUM KETAMINE HYDROCHLORIDE, KETAMINE HYDROCHLORIDE KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE LEUCOVORIN CALCIUM PRESERVATIVE FREE, LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM LEVOCARNITINE, LEVOCARNITINE LORAZEPAM, LORAZEPAM MESNA, MESNA METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM METHOTREXATE SODIUM, METHOTREXATE SODIUM MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE MILRINONE LACTATE, MILRINONE LACTATE MITOMYCIN, MITOMYCIN MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE OCTREOTIDE ACETATE (PRESERVATIVE FREE), OCTREOTIDE ACETATE OCTREOTIDE ACETATE, OCTREOTIDE ACETATE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE PACLITAXEL, PACLITAXEL PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM PHENTOLAMINE MESYLATE, PHENTOLAMINE MESYLATE POLYMYXIN B SULFATE, POLYMYXIN B SULFATE PROCHLORPERAZINE EDISYLATE, PROCHLORPERAZINE EDISYLATE PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE RIFAMPIN, RIFAMPIN SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE TERBUTALINE SULFATE, TERBUTALINE SULFATE TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE THIOTEPA, THIOTEPA VALPROATE SODIUM, VALPROATE SODIUM
VECURONIUM BROMIDE, VECURONIUM BROMIDE

VINBLASTINE SULFATE, VINBLASTINE SULFATE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** B **

* BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC VINORELBINE TARTRATE, VINORELBINE TARTRATE BEDFORD LABS * BEDFORD LABORATORIES ALLOPURINOL SODIUM, ALLOPURINOL SODIUM AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE CARBOPLATIN, CARBOPLATIN DIHYDROERGOTAMINE MESYLATE, DIHYDROERGOTAMINE MESYLATE ESMOLOL HYDROCHLORIDE, ESMOLOL HYDROCHLORIDE FENOLDOPAM MESYLATE, FENOLDOPAM MESYLATE FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE FLUMAZENIL, FLUMAZENIL GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE IDARUBICIN HYDROCHLORIDE, IDARUBICIN HYDROCHLORIDE IFOSFAMIDE, IFOSFAMIDE IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE LORAZEPAM PRESERVATIVE FREE, LORAZEPAM MELPHALAN HYDROCHLORIDE, MELPHALAN HYDROCHLORIDE METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE SODIUM SUCCINATE METOPROLOL TARTRATE, METOPROLOL TARTRATE MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MILRINONE LACTATE ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER, ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE ORPHENADRINE CITRATE, ORPHENADRINE CITRATE PENTOSTATIN, PENTOSTATIN SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

TORSEMIDE, TORSEMIDE

BEIJING DOUBLE CRANE * BEIJING DOUBLE CRANE PHARMACEUTICAL CO LTD FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

MELOXICAM, MELOXICAM

BELCHER PHARMS * BELCHER PHARMACEUTICALS LLC CEPHALEXIN, CEPHALEXIN BEN VENUE * BEN VENUE LABORATORIES INC FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

BEXIMCO USA * BEXIMCO PHARMACEUTICALS USA INC CARVEDILOL, CARVEDILOL BIO NUCLEONICS * BIO NUCLEONICS INC STRONTIUM CHLORIDE SR-89, BIOALLIANCE PHARMA * BIOALLIANCE PHARMA ORAVIG, MICONAZOLE BIOKEY * BIOKEY INC BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE

LEVETIRACETAM, LEVETIRACETAM

BIOMARIN PHARM * BIOMARIN PHARMACEUTICAL INC KUVAN, SAPROPTERIN DIHYDROCHLORIDE BIONICHE PHARMA * BIONICHE PHARMA USA LLC AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM

COSYNTROPIN, COSYNTROPIN

STRONTIUM CHLORIDE SR-89

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** B **

* BIONICHE PHARMA USA LLC DIMETHYL SULFOXIDE, DIMETHYL SULFOXIDE DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE ENLON, EDROPHONIUM CHLORIDE ESMOLOL HYDROCHLORIDE, ESMOLOL HYDROCHLORIDE FLUOROURACIL, FLUOROURACIL IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE KETAMINE HYDROCHLORIDE, KETAMINE HYDROCHLORIDE MEFOXIN IN PLASTIC CONTAINER, CEFOXITIN SODIUM METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM RIMSO-50, DIMETHYL SULFOXIDE

SOTRADECOL, SODIUM TETRADECYL SULFATE

BIONICHE PHARMA USA * BIONICHE PHARMA USA LLC CARBOPLATIN, CARBOPLATIN DURACLON, CLONIDINE HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE FOMEPIZOLE, FOMEPIZOLE IBUTILIDE FUMARATE, IBUTILIDE FUMARATE MELPHALAN HYDROCHLORIDE, MELPHALAN HYDROCHLORIDE METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE ROCURONIUM BROMIDE, ROCURONIUM BROMIDE

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

BIOVAIL TECHNOLOGIES * BIOVAIL TECHNOLOGIES LTD MEPHYTON, PHYTONADIONE BLAIREX * BLAIREX LABORATORIES INC BRONCHO SALINE, SODIUM CHLORIDE BLU CARIBE * BLU CARIBE INC GEMFIBROZIL, SIMVASTATIN,

(OTC)

GEMFIBROZIL

SIMVASTATIN

BOCA PHARMA * BOCA PHARMACAL INC ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE, ACETAMINOPHEN ALPRAZOLAM, ALPRAZOLAM CARBINOXAMINE MALEATE, CARBINOXAMINE MALEATE GLYCOPYRROLATE, GLYCOPYRROLATE HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN
LEVETIRACETAM, LEVETIRACETAM

METHSCOPOLAMINE BROMIDE, METHSCOPOLAMINE BROMIDE
BOEHRINGER INGELHEIM * BOEHRINGER INGELHEIM CATAPRES, CLONIDINE HYDROCHLORIDE CATAPRES-TTS-1, CLONIDINE CATAPRES-TTS-2, CLONIDINE CATAPRES-TTS-3, CLONIDINE MICARDIS HCT, HYDROCHLOROTHIAZIDE MICARDIS, TELMISARTAN MIRAPEX, PRAMIPEXOLE DIHYDROCHLORIDE
ZANTAC 150, RANITIDINE HYDROCHLORIDE (OTC)

ZANTAC 75, RANITIDINE HYDROCHLORIDE (OTC)
* BOEHRINGER INGELHEIM PHARMACEUTICALS INC AGGRENOX, ASPIRIN APTIVUS, TIPRANAVIR ATROVENT HFA, IPRATROPIUM BROMIDE ATROVENT, IPRATROPIUM BROMIDE
COMBIVENT RESPIMAT, ALBUTEROL SULFATE

COMBIVENT, ALBUTEROL SULFATE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** B **

* BOEHRINGER INGELHEIM PHARMACEUTICALS INC FLOMAX, TAMSULOSIN HYDROCHLORIDE MIRAPEX ER, PRAMIPEXOLE DIHYDROCHLORIDE MOBIC, MELOXICAM PERSANTINE, DIPYRIDAMOLE PRADAXA, DABIGATRAN ETEXILATE MESYLATE SPIRIVA, TIOTROPIUM BROMIDE MONOHYDRATE TRADJENTA, LINAGLIPTIN TWYNSTA, AMLODIPINE BESYLATE VIRAMUNE XR, NEVIRAPINE

VIRAMUNE, NEVIRAPINE

BRACCO * BRACCO DIAGNOSTICS INC CARDIOGEN-82, RUBIDIUM CHLORIDE RB-82 CHOLETEC, TECHNETIUM TC-99M MEBROFENIN KIT CHOLOGRAFIN MEGLUMINE, IODIPAMIDE MEGLUMINE CHROMITOPE SODIUM, SODIUM CHROMATE CR-51 CYSTOGRAFIN DILUTE, DIATRIZOATE MEGLUMINE CYSTOGRAFIN, DIATRIZOATE MEGLUMINE GASTROGRAFIN, DIATRIZOATE MEGLUMINE ISOVUE-200, IOPAMIDOL ISOVUE-250, IOPAMIDOL ISOVUE-300, IOPAMIDOL ISOVUE-370, IOPAMIDOL ISOVUE-M 200, IOPAMIDOL ISOVUE-M 300, IOPAMIDOL KINEVAC, SINCALIDE MDP-BRACCO, TECHNETIUM TC-99M MEDRONATE KIT MULTIHANCE MULTIPACK, GADOBENATE DIMEGLUMINE MULTIHANCE, GADOBENATE DIMEGLUMINE PROHANCE MULTIPACK, GADOTERIDOL PROHANCE, GADOTERIDOL
RENOGRAFIN-76, DIATRIZOATE MEGLUMINE

SINOGRAFIN, DIATRIZOATE MEGLUMINE
BRAINTREE * BRAINTREE LABORATORIES INC AXID, NIZATIDINE GOLYTELY, POLYETHYLENE GLYCOL 3350 HALFLYTELY, BISACODYL
NULYTELY, POLYETHYLENE GLYCOL 3350

NULYTELY-FLAVORED, POLYETHYLENE GLYCOL 3350
BRAINTREE LABS * BRAINTREE LABORATORIES INC SUPREP BOWEL PREP KIT, MAGNESIUM SULFATE ANHYDROUS BRECKENRIDGE PHARM * BRECKENRIDGE PHARMACEUTICAL INC CILOSTAZOL, CILOSTAZOL ESTRADIOL AND NORETHINDRONE ACETATE, ESTRADIOL LEVETIRACETAM, LEVETIRACETAM MELOXICAM, MELOXICAM METHSCOPOLAMINE BROMIDE, METHSCOPOLAMINE BROMIDE OXCARBAZEPINE, OXCARBAZEPINE POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE
BRIGHTSTONE * BRIGHTSTONE PHARMA INC ISOSORBIDE MONONITRATE,

ISOSORBIDE MONONITRATE

BRISTOL * BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO BICNU, CARMUSTINE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** B **

BRISTOL MYERS SQUIBB * BRISTOL MYERS SQUIBB AZACTAM, AZTREONAM BARACLUDE, ENTECAVIR GLUCOVANCE, GLYBURIDE KOMBIGLYZE XR, METFORMIN HYDROCHLORIDE LYSODREN, MITOTANE
MEGACE, MEGESTROL ACETATE

PRAVACHOL, PRAVASTATIN SODIUM
* BRISTOL MYERS SQUIBB CO AZACTAM IN PLASTIC CONTAINER, AZTREONAM CEENU, LOMUSTINE DROXIA, HYDROXYUREA GLUCOPHAGE XR, METFORMIN HYDROCHLORIDE HYDREA, HYDROXYUREA IXEMPRA KIT, IXABEPILONE ONGLYZA, SAXAGLIPTIN HYDROCHLORIDE REYATAZ, ATAZANAVIR SULFATE SPRYCEL, DASATINIB
SUSTIVA, EFAVIRENZ

VIDEX EC, DIDANOSINE
* BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE ESTRACE, ESTRADIOL ETOPOPHOS PRESERVATIVE FREE, ETOPOSIDE PHOSPHATE GLUCOPHAGE, METFORMIN HYDROCHLORIDE MONOPRIL, FOSINOPRIL SODIUM VIDEX, DIDANOSINE
VUMON, TENIPOSIDE

ZERIT, STAVUDINE
* BRISTOL MYERS SQUIBB PHARMA CO
COUMADIN, WARFARIN SODIUM

SUSTIVA, EFAVIRENZ
BRYAN * BRYAN CORP
SCLEROSOL, TALC

TALC, TALC
CADENCE PHARMS * CADENCE PHARMACEUTICALS INC OFIRMEV, ACETAMINOPHEN CADISTA PHARMS * CADISTA PHARMACEUTICALS INC ALENDRONATE SODIUM, ALENDRONATE SODIUM CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC)
LAMOTRIGINE, LAMOTRIGINE

OXCARBAZEPINE, OXCARBAZEPINE
CANYON * CANYON PHARMACEUTICALS INC IPRIVASK, DESIRUDIN RECOMBINANT CARACO * CARACO PHARMACEUTICAL LABORATORIES LTD ALLOPURINOL, ALLOPURINOL AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE AMLODIPINE BESYLATE, AMLODIPINE BESYLATE ATENOLOL, ATENOLOL BACLOFEN, BACLOFEN CARVEDILOL, CARVEDILOL CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC)
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

CLONAZEPAM, CLONAZEPAM

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** C **

* CARACO PHARMACEUTICAL LABORATORIES LTD CLOZAPINE, CLOZAPINE DIGOXIN, DIGOXIN ELIXOPHYLLIN, THEOPHYLLINE FLUMADINE, RIMANTADINE HYDROCHLORIDE FLURBIPROFEN, FLURBIPROFEN FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE GLIPIZIDE, GLIPIZIDE HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE MELOXICAM, MELOXICAM MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE METHIMAZOLE, METHIMAZOLE METOPROLOL TARTRATE, METOPROLOL TARTRATE MIRTAZAPINE, MIRTAZAPINE OXAPROZIN, OXAPROZIN PAROMOMYCIN SULFATE, PAROMOMYCIN SULFATE PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE SYNALGOS-DC, ASPIRIN THEOCHRON, THEOPHYLLINE TICLOPIDINE HYDROCHLORIDE, TICLOPIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
CARDINAL HEALTH 414 * CARDINAL HEALTH 414 LLC TECHNETIUM TC 99M SESTAMIBI,

TECHNETIUM TC-99M SESTAMIBI KIT

CARDINAL HLTH * CARDINAL HEALTH CHLORAPREP ONE-STEP SEPP, CHLORHEXIDINE GLUCONATE (OTC) CHLORAPREP SINGLE SWABSTICK, CHLORHEXIDINE GLUCONATE (OTC)

CHLORAPREP TRIPLE SWABSTICK, CHLORHEXIDINE GLUCONATE (OTC)

CAREFUSION * CAREFUSION 213 LLC CHLORAPREP ONE-STEP FREPP, CHLORHEXIDINE GLUCONATE (OTC) CHLORAPREP ONE-STEP, CHLORHEXIDINE GLUCONATE (OTC) CHLORAPREP WITH TINT, CHLORHEXIDINE GLUCONATE (OTC)
PHARMASEAL SCRUB CARE, CHLORHEXIDINE GLUCONATE (OTC)
CARLSBAD * CARLSBAD TECHNOLOGY INC ACYCLOVIR, ACYCLOVIR CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE DICLOFENAC SODIUM, DICLOFENAC SODIUM FAMOTIDINE, FAMOTIDINE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE GLIMEPIRIDE, GLIMEPIRIDE LOVASTATIN, LOVASTATIN
MELOXICAM, MELOXICAM

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
CAROLINA MEDCL * CAROLINA MEDICAL PRODUCTS CO AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE HYDROCORTISONE IN ABSORBASE, HYDROCORTISONE ISONIAZID, ISONIAZID SODIUM POLYSTYRENE SULFONATE, SODIUM POLYSTYRENE SULFONATE SPS, SODIUM POLYSTYRENE SULFONATE
TRIAMCINOLONE ACETONIDE IN ABSORBASE, TRIAMCINOLONE ACETONIDE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** C **

CATALENT * CATALENT PHARMA SOLUTIONS LLC

NIFEDIPINE, NIFEDIPINE

VALPROIC ACID, VALPROIC ACID
CEDAR PHARMS * CEDAR PHARMACEUTICALS LLC
METHIMAZOLE, METHIMAZOLE
SODIUM POLYSTYRENE SULFONATE, CELGENE * CELGENE CORP ISTODAX, ROMIDEPSIN REVLIMID, LENALIDOMIDE
THALOMID, THALIDOMIDE

VIDAZA, AZACITIDINE
CEPHALON * CEPHALON INC ACTIQ, FENTANYL CITRATE FENTORA, FENTANYL CITRATE GABITRIL, TIAGABINE HYDROCHLORIDE NUVIGIL, ARMODAFINIL PROVIGIL, MODAFINIL
TREANDA, BENDAMUSTINE HYDROCHLORIDE

TRISENOX, ARSENIC TRIOXIDE
CEPHAZONE PHARMA * CEPHAZONE PHARMA LLC CEFAZOLIN SODIUM, CEFAZOLIN SODIUM
CEFOTAXIME SODIUM, CEFOTAXIME SODIUM

CEFTRIAXONE, CEFTRIAXONE SODIUM
CEREXA * CEREXA INC TEFLARO,

SODIUM POLYSTYRENE SULFONATE

CEFTAROLINE FOSAMIL

CHATTEM * CHATTEM INC

SELSUN, SELENIUM SULFIDE
UNISOM, DOXYLAMINE SUCCINATE

(OTC)

CHEMISCH FBRK KRSSLR * CHEMISCHE FABRIK KREUSSLER & CO. GMBH ASCLERA, POLIDOCANOL CHIRHOCLIN * CHIRHOCLIN INC CHIRHOSTIM, SECRETIN SYNTHETIC HUMAN CIPHER PHARMS INC * CIPHER PHARMACEUTICALS INC
CONZIP, TRAMADOL HYDROCHLORIDE

LIPOFEN, FENOFIBRATE
CIPLA * CIPLA LTD RAMIPRIL, RAMIPRIL RISPERIDONE, RISPERIDONE
TRANDOLAPRIL, TRANDOLAPRIL

ZIDOVUDINE, ZIDOVUDINE
CIPLA LTD * CIPLA LTD DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE STAVUDINE, STAVUDINE TOPIRAMATE, TOPIRAMATE
ZALEPLON, ZALEPLON

ZIDOVUDINE, ZIDOVUDINE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** C **

CITIUS PHARMS * CITIUS PHARMACEUTICALS LLC SUPRENZA, PHENTERMINE HYDROCHLORIDE CITRUSPHRMA * CITRUSPHRMA LLC SODIUM POLYSTYRENE SULFONATE,

SODIUM POLYSTYRENE SULFONATE

CLARIS LIFESCIENCES * CLARIS LIFESCIENCES LTD AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE BUTORPHANOL TARTRATE PRESERVATIVE FREE, BUTORPHANOL TARTRATE BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN CIPROFLOXACIN, CIPROFLOXACIN DIPYRIDAMOLE, DIPYRIDAMOLE FAMOTIDINE PRESERVATIVE FREE (PHARMACY BULK), FAMOTIDINE FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE FLUMAZENIL, FLUMAZENIL FLUPHENAZINE DECANOATE, FLUPHENAZINE DECANOATE FULCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER, FLUCONAZOLE GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE HALOPERIDOL, HALOPERIDOL LACTATE KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE METRONIDAZOLE IN PLASTIC CONTAINER, METRONIDAZOLE MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MILRINONE LACTATE MILRINONE LACTATE IN DEXTROSE 5%, MILRINONE LACTATE MILRINONE LACTATE, MILRINONE LACTATE ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER, ONDANSETRON HYDROCHLORIDE CLINIGEN HLTHCARE * CLINIGEN HEALTHCARE LTD FOSCAVIR, FOSCARNET SODIUM CLINTEC NUTR * CLINTEC NUTRITION CO SUB CLINIQUE CLINISOL 15% SULFITE FREE IN PLASTIC CONTAINER, CLONMEL HLTHCARE * CLONMEL HEALTHCARE LTD MORPHINE SULFATE, MORPHINE SULFATE CNS THERAPS INC * CNS THERAPEUTICS INC GABLOFEN, BACLOFEN CNTY LINE PHARMS * COUNTY LINE PHARMACEUTICALS LLC UREX, METHENAMINE HIPPURATE COASTAL PHARMS * COASTAL PHARMACEUTICALS BROMFENAC SODIUM, BROMFENAC SODIUM
NYSTATIN, NYSTATIN

OXYCODONE AND ASPIRIN, ASPIRIN
* COASTAL PHARMACEUTICALS INC LIOTHYRONINE SODIUM, LIOTHYRONINE SODIUM METHAMPHETAMINE HYDROCHLORIDE, METHAMPHETAMINE HYDROCHLORIDE
OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
COBALT LABS INC * COBALT LABORATORIES INC LEVETIRACETAM, LEVETIRACETAM

AMINO ACIDS

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** C **

COLGATE * COLGATE ORAL PHARMACEUTICALS INC

ORABASE HCA, HYDROCORTISONE ACETATE

PERIOGARD, CHLORHEXIDINE GLUCONATE
COLGATE PALMOLIVE * COLGATE PALMOLIVE COLGATE TOTAL, SODIUM FLUORIDE CONNECTICS * CONNECTICS CORP LUXIQ, BETAMETHASONE VALERATE CONTRACT PHARMA * CONTRACT PHARMACAL CORP CETIRIZINE HYDROCHLORIDE ALLERGY,

(OTC)

CETIRIZINE HYDROCHLORIDE

(OTC)

CONTRACT PHARMACAL * CONTRACT PHARMACAL CORP CIMETIDINE, CIMETIDINE (OTC) FOLIC ACID, FOLIC ACID IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE, IBUPROFEN (OTC) IBUPROFEN, IBUPROFEN IBUPROFEN, IBUPROFEN (OTC) LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC) NAPROXEN SODIUM, NAPROXEN SODIUM (OTC) PREDNISONE, PREDNISONE
PROFEN, IBUPROFEN (OTC)

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC)
CONTROLLED THERAP * CONTROLLED THERAPEUTICS (SCOTLAND) LTD CERVIDIL, DINOPROSTONE COREPHARMA * COREPHARMA LLC ALBENZA, ALBENDAZOLE ALPRAZOLAM, ALPRAZOLAM BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE BENZTROPINE MESYLATE, BENZTROPINE MESYLATE CARISOPRODOL, CARISOPRODOL CILOSTAZOL, CILOSTAZOL CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE DARAPRIM, PYRIMETHAMINE DECLOMYCIN, DEMECLOCYCLINE HYDROCHLORIDE DEXEDRINE, DEXTROAMPHETAMINE SULFATE DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, ASPARTATE
DIETHYLPROPION HYDROCHLORIDE, DIETHYLPROPION HYDROCHLORIDE

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

E-GLADES, ERYTHROMYCIN

GLIMEPIRIDE, GLIMEPIRIDE

GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE

GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE

GLYBURIDE, GLYBURIDE

GLYCOPYRROLATE, GLYCOPYRROLATE

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

HYDROCORTISONE, HYDROCORTISONE

ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE

LEVOCARNITINE, LEVOCARNITINE

MELOXICAM, MELOXICAM

METHENAMINE HIPPURATE, METHENAMINE HIPPURATE

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE

POTASSIUM CITRATE, POTASSIUM CITRATE

AMPHETAMINE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** C **

* COREPHARMA LLC PYRIDOSTIGMINE BROMIDE, PYRIDOSTIGMINE BROMIDE RIMANTADINE HYDROCHLORIDE, RIMANTADINE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE TRANDOLAPRIL, TRANDOLAPRIL URSODIOL, URSODIOL

ZONISAMIDE, ZONISAMIDE

CORIA * CORIA LABORATORIES LTD NUTRACORT, HYDROCORTISONE CORNERSTONE THERAP * CORNERSTONE THERAPEUTICS INC CUROSURF, PORACTANT ALFA FACTIVE, GEMIFLOXACIN MESYLATE SPECTRACEF, CEFDITOREN PIVOXIL ZYFLO CR, ZILEUTON

ZYFLO, ZILEUTON

COVIDIEN * COVIDIEN LYMPHAZURIN, ISOSULFAN BLUE

THERMAZENE, SILVER SULFADIAZINE

COVIS PHARMA * COVIS PHARMA SARL LANOXIN PEDIATRIC, LANOXIN, DIGOXIN

DIGOXIN

CPPI CV * CP PHARMACEUTICALS INTERNATIONAL CV LYRICA, PREGABALIN

SUTENT, SUNITINIB MALATE

CROWN LABS * CROWN LABORATORIES INC ALA-CORT, HYDROCORTISONE ALA-SCALP, HYDROCORTISONE

TRIDERM, TRIAMCINOLONE ACETONIDE

CSL BEHRING * CSL BEHRING LLC STIMATE (NEEDS NO REFRIGERATION), CUBIST * CUBIST PHARMACEUTICALS INC CUBICIN, DAPTOMYCIN CUMBERLAND PHARMS * CUMBERLAND PHARMACEUTICALS INC ACETADOTE, ACETYLCYSTEINE

CALDOLOR, IBUPROFEN

CYPRESS BIOSCIENCE * CYPRESS BIOSCIENCE INC SAVELLA, MILNACIPRAN HYDROCHLORIDE CYPRESS PHARM * CYPRESS PHARMACEUTICAL INC CARBINOXAMINE MALEATE, CARBINOXAMINE MALEATE CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) ELIPHOS, CALCIUM ACETATE EPINASTINE HYDROCHLORIDE, EPINASTINE HYDROCHLORIDE LEVETIRACETAM, LEVETIRACETAM RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE REZIRA, HYDROCODONE BITARTRATE

ZUTRIPRO, CHLORPHENIRAMINE MALEATE

DESMOPRESSIN ACETATE

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APPENDIX B
DAIICHI * DAIICHI PHARMACEUTICAL CORP FLOXIN OTIC, OFLOXACIN

PRODUCT NAME SORTED BY APPLICANT

** D **

DAIICHI SANKYO * DAIICHI SANKYO INC AZOR, AMLODIPINE BESYLATE BENICAR HCT, HYDROCHLOROTHIAZIDE BENICAR, OLMESARTAN MEDOXOMIL
TRIBENZOR, AMLODIPINE BESYLATE

WELCHOL, COLESEVELAM HYDROCHLORIDE
DAIICHI SANKYO CO * DAIICHI SANKYO CO LTD EVOXAC, CEVIMELINE HYDROCHLORIDE DANCO LABS LLC * DANCO LABORATORIES LLC MIFEPREX, MIFEPRISTONE DAVA INTL INC * DAVA INTERNATIONAL INC ALPRAZOLAM, ALPRAZOLAM DAVA PHARMS INC * DAVA PHARMACEUTICALS INC ACYCLOVIR, ACYCLOVIR AMOXICILLIN, AMOXICILLIN AMPICILLIN TRIHYDRATE, AMPICILLIN/AMPICILLIN TRIHYDRATE ATENOLOL, ATENOLOL CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE CIMETIDINE, CIMETIDINE CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE DIAZEPAM, DIAZEPAM DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE FUROSEMIDE, FUROSEMIDE GEMFIBROZIL, GEMFIBROZIL GLYBURIDE (MICRONIZED), GLYBURIDE HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE METHOTREXATE SODIUM, METHOTREXATE SODIUM NAPROXEN, NAPROXEN PENICILLIN V POTASSIUM, PENICILLIN V POTASSIUM PROPYLTHIOURACIL, PROPYLTHIOURACIL PYRAZINAMIDE, PYRAZINAMIDE
SELEGILINE HYDROCHLORIDE, SELEGILINE HYDROCHLORIDE

VOSPIRE ER, ALBUTEROL SULFATE
DAVIS AND GECK * DAVIS AND GECK DIV AMERICAN CYANAMID CO
PRE-OP II, HEXACHLOROPHENE

PRE-OP, HEXACHLOROPHENE
DENCO ASSET * DENCO ASSET LLC DENAVIR, PENCICLOVIR SODIUM DENTSPLY PHARM * DENTSPLY PHARMACEUTICAL CITANEST PLAIN DENTAL, PRILOCAINE HYDROCHLORIDE ORAQIX, LIDOCAINE POLOCAINE, MEPIVACAINE HYDROCHLORIDE
XYLOCAINE DENTAL WITH EPINEPHRINE, EPINEPHRINE

XYLOCAINE DENTAL, LIDOCAINE HYDROCHLORIDE
* DENTSPLY PHARMACEUTICAL INC CITANEST FORTE DENTAL, EPINEPHRINE BITARTRATE

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APPENDIX B
DEPOMED INC * DEPOMED INC GRALISE, GABAPENTIN

PRODUCT NAME SORTED BY APPLICANT

** D **

DEPROCO * DEPROCO INC LIGNOSPAN FORTE, EPINEPHRINE BITARTRATE LIGNOSPAN STANDARD, EPINEPHRINE BITARTRATE SCANDONEST L, LEVONORDEFRIN
SCANDONEST PLAIN, MEPIVACAINE HYDROCHLORIDE

SEPTOCAINE, ARTICAINE HYDROCHLORIDE
DEXCEL LTD * DEXCEL LTD
DICLOFENAC SODIUM, DICLOFENAC SODIUM

ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE
DEXCEL PHARMA * DEXCEL PHARMA TECHNOLOGIES LTD
OMEPRAZOLE, OMEPRAZOLE (OTC)

PERIOCHIP, CHLORHEXIDINE GLUCONATE
DEY * DEY LP ACCUNEB, ALBUTEROL SULFATE ALBUTEROL SULFATE, ALBUTEROL SULFATE CROMOLYN SODIUM, CROMOLYN SODIUM DUONEB, ALBUTEROL SULFATE IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE
LEVALBUTEROL HYDROCHLORIDE, LEVALBUTEROL HYDROCHLORIDE

METAPROTERENOL SULFATE, METAPROTERENOL SULFATE
DEY PHARMA * DEY PHARMA LP PERFOROMIST,

FORMOTEROL FUMARATE

DIALYSIS SUPS * DIALYSIS SUPPLIES INC

NORMOCARB HF 25, MAGNESIUM CHLORIDE

NORMOCARB HF 35, MAGNESIUM CHLORIDE
DORC * DORC INTERNATIONAL BV
MEMBRANEBLUE, TRYPAN BLUE

VISIONBLUE, TRYPAN BLUE
DOW PHARM SCI * DOW PHARMACEUTICAL SCIENCES ACANYA, BENZOYL PEROXIDE DOW PHARM SCIENCES * DOW PHARMACEUTICAL SCIENCES INC AKNE-MYCIN, ERYTHROMYCIN
ATRALIN, TRETINOIN
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE, DR REDDYS LA * DR REDDYS LABORATORIES LOUISIANA LLC IBUPROFEN, IBUPROFEN IBUPROFEN, IBUPROFEN (OTC) LOPURIN, ALLOPURINOL
SSD AF, SILVER SULFADIAZINE

SSD, SILVER SULFADIAZINE
DR REDDYS LABS * DR REDDYS LABORATORIES LTD OMEPRAZOLE, OMEPRAZOLE DR REDDYS LABS INC * DR REDDYS LABORATORIES INC AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE,

BENZOYL PEROXIDE

AMLODIPINE BESYLATE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** D **

* DR REDDYS LABORATORIES INC AMOXIL, AMOXICILLIN AUGMENTIN '125', AMOXICILLIN AUGMENTIN '200', AMOXICILLIN AUGMENTIN '250', AMOXICILLIN AUGMENTIN '400', AMOXICILLIN AUGMENTIN '500', AMOXICILLIN AUGMENTIN '875', AMOXICILLIN AUGMENTIN ES-600, AMOXICILLIN AUGMENTIN XR, AMOXICILLIN FINASTERIDE, FINASTERIDE FLUCONAZOLE, FLUCONAZOLE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE, GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE IBUPROFEN, IBUPROFEN IBUPROFEN, IBUPROFEN (OTC) LAROTID, AMOXICILLIN LEVOFLOXACIN, LEVOFLOXACIN MELOXICAM, MELOXICAM METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE, NAPROXEN SODIUM (OTC) NAPROXEN SODIUM, NAPROXEN SODIUM (OTC) NEFAZODONE HYDROCHLORIDE, NEFAZODONE HYDROCHLORIDE PRAVASTATIN SODIUM, PRAVASTATIN SODIUM RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE SIMVASTATIN, SIMVASTATIN SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE

TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE

DR REDDYS LABS LTD * DR REDDYS LABORATORIES LIMITED LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE * DR REDDYS LABORATORIES LTD ALENDRONATE SODIUM, ALENDRONATE SODIUM AMLODIPINE BESYLATE, AMLODIPINE BESYLATE ANASTROZOLE, ANASTROZOLE BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE CARVEDILOL, CARVEDILOL CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC) CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC) CIPROFLOXACIN EXTENDED RELEASE, CIPROFLOXACIN CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOUR, DESLORATADINE DESLORATADINE, DESLORATADINE DIVALPROEX SODIUM, DIVALPROEX SODIUM DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE FAMOTIDINE, FAMOTIDINE FAMOTIDINE, FAMOTIDINE (OTC) FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC) FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE (OTC)
FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC)

FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE

FINASTERIDE, FINASTERIDE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** D **

* DR REDDYS LABORATORIES LTD FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE FONDAPARINUX SODIUM, FONDAPARINUX SODIUM GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE GLIMEPIRIDE, GLIMEPIRIDE GLYCOPYRROLATE, GLYCOPYRROLATE GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE IBUPROFEN AND DIPHENHYDRAMINE CITRATE, DIPHENHYDRAMINE CITRATE IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE, IBUPROFEN (OTC) IBUPROFEN, IBUPROFEN (OTC) IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE LAMOTRIGINE, LAMOTRIGINE LANSOPRAZOLE, LANSOPRAZOLE LETROZOLE, LETROZOLE LEVETIRACETAM, LEVETIRACETAM MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL NABUMETONE, NABUMETONE NAPROXEN SODIUM, NAPROXEN SODIUM NATEGLINIDE, NATEGLINIDE NIZATIDINE, NIZATIDINE OFLOXACIN, OFLOXACIN OLANZAPINE, OLANZAPINE OMEPRAZOLE MAGNESIUM, OMEPRAZOLE MAGNESIUM (OTC) OMEPRAZOLE, OMEPRAZOLE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE OXAPROZIN, OXAPROZIN PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM PRIMIDONE, PRIMIDONE RAMIPRIL, RAMIPRIL RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC) RISPERIDONE, RISPERIDONE SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE TACROLIMUS, TACROLIMUS TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE TRANDOLAPRIL, TRANDOLAPRIL VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE ZAFIRLUKAST, ZAFIRLUKAST
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

ZONISAMIDE, ZONISAMIDE

(OTC)

DRAXIMAGE * DRAXIMAGE INC DRAXIMAGE MDP-25, TECHNETIUM TC-99M MEDRONATE DTPA, TECHNETIUM TC-99M PENTETATE KIT HICON, SODIUM IODIDE I-131 SODIUM IODIDE I-131, SODIUM IODIDE I-131 TECHNETIUM TC 99M ALBUMIN AGGREGATED KIT, TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT TECHNETIUM TC 99M SESTAMIBI, TECHNETIUM TC-99M SESTAMIBI KIT DURAMED * DURAMED PHARMACEUTICALS INC NORDETTE-28, ETHINYL ESTRADIOL PLAN B ONE-STEP, LEVONORGESTREL
PLAN B ONE-STEP, LEVONORGESTREL (OTC)

REVIA, NALTREXONE HYDROCHLORIDE
DURAMED PHARMS BARR * DURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC AVIANE-28, ETHINYL ESTRADIOL CRYSELLE, ETHINYL ESTRADIOL
DESOGESTREL AND ETHINYL ESTRADIOL, DESOGESTREL

DIAMOX, ACETAZOLAMIDE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

B - 48

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** D **

* DURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC DIAMOX, ACETAZOLAMIDE SODIUM ENPRESSE-28, ETHINYL ESTRADIOL METHYLPREDNISOLONE, METHYLPREDNISOLONE OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE VELIVET, DESOGESTREL ZEBETA, BISOPROLOL FUMARATE

ZIAC, BISOPROLOL FUMARATE

DURAMED RES * DURAMED RESEARCH INC AYGESTIN, NORETHINDRONE ACETATE PARAGARD T 380A, COPPER

SEASONALE, ETHINYL ESTRADIOL

DUSA * DUSA PHARMACEUTICALS INC LEVULAN, AMINOLEVULINIC ACID HYDROCHLORIDE EAGLE PHARMS * EAGLE PHARMACEUTICALS INC ARGATROBAN IN SODIUM CHLORIDE,

ARGATROBAN

EASTMAN KODAK * EASTMAN KODAK CO LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE,

EPINEPHRINE

EBEWE PHARMA * EBEWE PHARMA GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE * EBEWE PHARMA GES MBH NFG KG CARBOPLATIN, CARBOPLATIN EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE FLUOROURACIL, FLUOROURACIL IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM OXALIPLATIN, OXALIPLATIN
PACLITAXEL, PACLITAXEL

VINORELBINE TARTRATE, VINORELBINE TARTRATE
ECOLAB * ECOLAB INC CHG SCRUB, CIDA-STAT,

CHLORHEXIDINE GLUCONATE CHLORHEXIDINE GLUCONATE

(OTC)

(OTC)

ECR * ECR PHARMACEUTICALS DEXAMETHASONE, DEXAMETHASONE EDGEMONT PHARMS LLC * EDGEMONT PHARMACEUTICALS LLC FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE EGIS * EGIS PHARMACEUTICALS BUSPIRONE HYDROCHLORIDE, EI INC * EI INC THEROXIDIL,

BUSPIRONE HYDROCHLORIDE

MINOXIDIL

(OTC)

EISAI INC * EISAI INC ACIPHEX, RABEPRAZOLE SODIUM ARICEPT ODT, DONEPEZIL HYDROCHLORIDE ARICEPT, DONEPEZIL HYDROCHLORIDE BANZEL, RUFINAMIDE DACOGEN, DECITABINE FRAGMIN, DALTEPARIN SODIUM

GLIADEL, CARMUSTINE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

B - 49

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** E **

* EISAI INC HALAVEN, ERIBULIN MESYLATE HEXALEN, ALTRETAMINE LUSEDRA, FOSPROPOFOL DISODIUM PANRETIN, ALITRETINOIN SALAGEN, PILOCARPINE HYDROCHLORIDE TARGRETIN, BEXAROTENE
ZONEGRAN, ZONISAMIDE
EKR THERAP * EKR THERAPEUTICS INC CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE CARDENE SR, NICARDIPINE HYDROCHLORIDE CARDENE, NICARDIPINE HYDROCHLORIDE
DEPODUR, MORPHINE SULFATE
ELAN DRUG * ELAN DRUG DELIVERY INC VERELAN PM, VERAPAMIL HYDROCHLORIDE ELAN PHARM * ELAN PHARMACEUTICAL RESEARCH CORP ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE
KETOPROFEN, KETOPROFEN
ELI LILLY AND CO * ELI LILLY AND CO AXIRON, TESTOSTERONE
EFFIENT, PRASUGREL HYDROCHLORIDE
ELI LILLY CO * ELI LILLY CO ADCIRCA, TADALAFIL
ZYPREXA RELPREVV, OLANZAPINE PAMOATE
ELITE LABS * ELITE LABORATORIES INC HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE
PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE
ELKINS SINN * ELKINS SINN DIV AH ROBINS CO INC MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE EMCURE PHARMS * EMCURE PHARMACEUTICALS LTD ONDANSETRON HYDROCHLORIDE,

ONDANSETRON HYDROCHLORIDE

EMCURE PHARMS USA * EMCURE PHARMACEUTICALS USA INC FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL METHIMAZOLE, METHIMAZOLE
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
EMCURE USA * EMCURE PHARMACEUTICALS USA INC BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE EMD SERONO * EMD SERONO INC CETROTIDE, CETRORELIX GONAL-F RFF PEN, FOLLITROPIN ALFA/BETA GONAL-F RFF, FOLLITROPIN ALFA/BETA GONAL-F, FOLLITROPIN ALFA/BETA LUVERIS, LUTROPIN ALFA OVIDREL, CHORIOGONADOTROPIN ALFA
SAIZEN, SOMATROPIN RECOMBINANT

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B - 50

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** E **

* EMD SERONO INC SEROPHENE, CLOMIPHENE CITRATE SEROSTIM, SOMATROPIN RECOMBINANT

ZORBTIVE, SOMATROPIN RECOMBINANT

EMMAUS MEDCL * EMMAUS MEDICAL INC NUTRESTORE, GLUTAMINE ENDO PHARM * ENDO PHARMACEUTICAL SOLUTIONS INC DELATESTRYL, TESTOSTERONE ENANTHATE SUPPRELIN LA, HISTRELIN ACETATE VALSTAR PRESERVATIVE FREE, VALRUBICIN

VANTAS, HISTRELIN ACETATE

ENDO PHARMS * ENDO PHARMACEUTICALS INC FELODIPINE, FELODIPINE FORTESTA, TESTOSTERONE FROVA, FROVATRIPTAN SUCCINATE LETROZOLE, LETROZOLE MORPHINE SULFATE, MORPHINE SULFATE MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL OPANA ER, OXYMORPHONE HYDROCHLORIDE OPANA, OXYMORPHONE HYDROCHLORIDE PERCOCET, ACETAMINOPHEN PERCODAN, ASPIRIN

ZYDONE, ACETAMINOPHEN

EPIC PHARMA * EPIC PHARMA INC GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE

NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE

* EPIC PHARMA LLC BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE FLAVOXATE HYDROCHLORIDE, FLAVOXATE HYDROCHLORIDE SULINDAC, SULINDAC
TRANDOLAPRIL, TRANDOLAPRIL

URSODIOL, URSODIOL
EPIC PHARMA LLC * EPIC PHARMA LLC AMLODIPINE BESYLATE,

AMLODIPINE BESYLATE

ERGOJECT * ERGOJECT LLC METHYLERGONOVINE MALEATE,

METHYLERGONOVINE MALEATE

ETHYPHARM * ETHYPHARM BUPRENORPHINE HYDROCHLORIDE, EURAND * EURAND AMERICA INC POTASSIUM CHLORIDE,

BUPRENORPHINE HYDROCHLORIDE

POTASSIUM CHLORIDE

EUSA PHARMA USA * EUSA PHARMA (USA) INC QUADRAMET, SAMARIUM SM-153 LEXIDRONAM PENTASODIUM EXALENZ BIOSCIENCE * EXALENZ BIOSCIENCE LTD IDKIT:HP, UREA C-13 EXCELLIUM * EXCELLIUM PHARMACEUTICAL INC FOLIC ACID, FOLIC ACID

FUROSEMIDE, FUROSEMIDE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B
*

PRODUCT NAME SORTED BY APPLICANT

** E **

EXCELLIUM PHARMACEUTICAL INC

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LORAZEPAM, LORAZEPAM

EXELA PHARMA SCIENCE * EXELA PHARMA SCIENCES NICARDIPINE HYDROCHLORIDE, EYETECH INC * EYETECH INC MACUGEN, PEGAPTANIB SODIUM FACTA FARMA * FACTA FARMACEUTICI SPA CEPHALEXIN, CEPHALEXIN

NICARDIPINE HYDROCHLORIDE

FALCON PHARMS * FALCON PHARMACEUTICALS INC TIMOLOL MALEATE, TIMOLOL MALEATE * FALCON PHARMACEUTICALS LTD DIPIVEFRIN HYDROCHLORIDE, DIPIVEFRIN HYDROCHLORIDE GENTAMICIN SULFATE, GENTAMICIN SULFATE LEVOBUNOLOL HYDROCHLORIDE, LEVOBUNOLOL HYDROCHLORIDE MAXITROL, DEXAMETHASONE METIPRANOLOL, METIPRANOLOL HYDROCHLORIDE TIMOLOL MALEATE, TIMOLOL MALEATE
TOBREX, TOBRAMYCIN

TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE, POLYMYXIN B SULFATE
FDC LTD * FDC LTD CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
OFLOXACIN, OFLOXACIN

TIMOLOL MALEATE, TIMOLOL MALEATE
FEINSTEIN * FEINSTEIN INSTITUTE MEDICAL RESEARCH
AMMONIA N 13, AMMONIA, N-13

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18
FERA PHARMS * FERA PHARMACEUTICALS LLC BACITRACIN ZINC AND POLYMYXIN B SULFATE, BACITRACIN ZINC BACITRACIN, BACITRACIN BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE, BACITRACIN ERYTHROMYCIN, ERYTHROMYCIN GENTAMICIN SULFATE, GENTAMICIN SULFATE NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC, BACITRACIN ZINC NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE, DEXAMETHASONE OFLOXACIN, OFLOXACIN
SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM

TOBRAMYCIN, TOBRAMYCIN
FERNDALE LABS * FERNDALE LABORATORIES INC HYDROCORTISONE ACETATE, HYDROCORTISONE ACETATE
MICORT-HC, HYDROCORTISONE ACETATE

PRAMOSONE, HYDROCORTISONE ACETATE
FERRING * FERRING PHARMACEUTICALS INC ACTHREL, CORTICORELIN OVINE TRIFLUTATE BRAVELLE, UROFOLLITROPIN CHORIONIC GONADOTROPIN, GONADOTROPIN, CHORIONIC DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE ENDOMETRIN, PROGESTERONE FIRMAGON, DEGARELIX ACETATE MENOPUR, LUTEINIZING HORMONE
MINIRIN, DESMOPRESSIN ACETATE

REPRONEX, LUTEINIZING HORMONE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** F **

* FERRING PHARMACEUTICALS INC TEV-TROPIN, SOMATROPIN RECOMBINANT FERRING PHARMS AS * FERRING PHARMACEUTICALS AS LYSTEDA, TRANEXAMIC ACID FLEMING * FLEMING AND CO PHARMACEUTICALS THYROSHIELD, POTASSIUM IODIDE

(OTC)

FOREST LABS * FOREST LABORATORIES INC BYSTOLIC, NEBIVOLOL HYDROCHLORIDE CAMPRAL, ACAMPROSATE CALCIUM CELEXA, CITALOPRAM HYDROBROMIDE LEXAPRO, ESCITALOPRAM OXALATE NAMENDA XR, MEMANTINE HYDROCHLORIDE NAMENDA, MEMANTINE HYDROCHLORIDE TESSALON, BENZONATATE THYROLAR-0.25, LIOTHYRONINE SODIUM THYROLAR-0.5, LIOTHYRONINE SODIUM THYROLAR-1, LIOTHYRONINE SODIUM THYROLAR-2, LIOTHYRONINE SODIUM

THYROLAR-3, LIOTHYRONINE SODIUM

FOREST LABS INC * FOREST LABORATORIES INC VIIBRYD, VILAZODONE HYDROCHLORIDE FOREST RES INST INC * FOREST RESEARCH INSTITUTE INC DALIRESP, ROFLUMILAST FOUGERA * E FOUGERA DIV ALTANA INC BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE BETAMETHASONE VALERATE, BETAMETHASONE VALERATE CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE FLUOCINONIDE, FLUOCINONIDE GENTAMICIN SULFATE, GENTAMICIN SULFATE HYDROCORTISONE, HYDROCORTISONE LIDOCAINE, LIDOCAINE NITROGLYCERIN, NITROGLYCERIN NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN

NYSTATIN, NYSTATIN

FOUGERA PHARMS * FOUGERA PHARMACEUTICALS INC ACLOVATE, ALCLOMETASONE DIPROPIONATE CUTIVATE, FLUTICASONE PROPIONATE ERYTHROMYCIN, ERYTHROMYCIN OXISTAT, OXICONAZOLE NITRATE PAMINE FORTE, METHSCOPOLAMINE BROMIDE PAMINE, METHSCOPOLAMINE BROMIDE PANDEL, HYDROCORTISONE PROBUTATE
SOLARAZE, DICLOFENAC SODIUM

TEMOVATE E, CLOBETASOL PROPIONATE
FRESENIUS * FRESENIUS KABI DEUTSCHLAND GMBH INTRALIPID 10%, SOYBEAN OIL INTRALIPID 20%, SOYBEAN OIL

INTRALIPID 30%, SOYBEAN OIL

* FRESENIUS USA INC INPERSOL-LC/LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, INPERSOL-LC/LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER,

CALCIUM CHLORIDE CALCIUM CHLORIDE

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APPENDIX B
*

PRODUCT NAME SORTED BY APPLICANT

** F **

FRESENIUS USA INC

INPERSOL-LC/LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

INPERSOL-LC/LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

FRESENIUS KABI ONCOL * FRESENIUS KABI ONCOLOGY PLC ANASTROZOLE, ANASTROZOLE BICALUTAMIDE, BICALUTAMIDE CARBOPLATIN, CARBOPLATIN EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE LETROZOLE, LETROZOLE MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE OXALIPLATIN, OXALIPLATIN
PACLITAXEL, PACLITAXEL

TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE
FRESENIUS MEDCL * FRESENIUS MEDICAL CARE NORTH AMERICA CALCITRIOL, CALCITRIOL DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE DELFLEX W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX-LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX-LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX-LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX-LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PHOSLO GELCAPS, CALCIUM ACETATE

PHOSLYRA, CALCIUM ACETATE

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE
FSC * FSC LABORATORIES INC PRIMSOL, TRIMETHOPRIM HYDROCHLORIDE FUTURE PAK * FUTURE PAK LTD K+10, POTASSIUM CHLORIDE G AND W LABS * G AND W LABORATORIES INC ACEPHEN, ACETAMINOPHEN (OTC) CICLOPIROX, CICLOPIROX FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE INDOMETHACIN, INDOMETHACIN METRONIDAZOLE, METRONIDAZOLE MICONAZOLE 7 COMBINATION PACK, MICONAZOLE NITRATE (OTC) MICONAZOLE NITRATE, MICONAZOLE NITRATE (OTC) MIGERGOT, CAFFEINE MOMETASONE FUROATE, MOMETASONE FUROATE PROCHLORPERAZINE, PROCHLORPERAZINE PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
PROMETHEGAN, PROMETHAZINE HYDROCHLORIDE

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

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B - 54

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** G **

G AND W LABS INC * G AND W LABORATORIES INC CALCIPOTRIENE, CALCIPOTRIENE

CICLOPIROX, CICLOPIROX

METRONIDAZOLE, METRONIDAZOLE
GALDERMA LABS * GALDERMA LABORATORIES INC
CLOBEX, CLOBETASOL PROPIONATE

EPIDUO, ADAPALENE
GALDERMA LABS LP * GALDERMA LABORATORIES L P CLOBEX, CLOBETASOL PROPIONATE * GALDERMA LABORATORIES LP CAPEX, FLUOCINOLONE ACETONIDE CLINDAGEL, CLINDAMYCIN PHOSPHATE CLOBEX, CLOBETASOL PROPIONATE DESOWEN, DESONIDE DIFFERIN, ADAPALENE LIDOCAINE AND TETRACAINE, LIDOCAINE METROCREAM, METRONIDAZOLE METROGEL, METRONIDAZOLE METROLOTION, METRONIDAZOLE METVIXIA, METHYL AMINOLEVULINATE HYDROCHLORIDE ORACEA, DOXYCYCLINE PERIOSTAT, DOXYCYCLINE HYCLATE
TRI-LUMA, FLUOCINOLONE ACETONIDE

VECTICAL, CALCITRIOL
GALDERMA R AND D * GALDERMA RESEARCH AND DEVELOPMENT INC DIFFERIN, ADAPALENE GALEN (UK) * GALEN LTD DAUNOXOME, GALEN LTD * GALEN LTD FEMRING,

DAUNORUBICIN CITRATE

ESTRADIOL ACETATE

GAMBRO RENAL PRODS * GAMBRO RENAL PRODUCTS PRISMASOL B22GK 2/0 IN PLASTIC CONTAINER, CALCIUM CHLORIDE PRISMASOL B22GK 4/0 IN PLASTIC CONTAINER, CALCIUM CHLORIDE PRISMASOL B22GK 4/2.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE PRISMASOL BGK 0/2.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE PRISMASOL BGK 2/0 IN PLASTIC CONTAINER, CALCIUM CHLORIDE PRISMASOL BGK 2/3.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE PRISMASOL BGK 4/0/1.2 IN PLASTIC CONTAINER, CALCIUM CHLORIDE PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL BK 0/0/1.2 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PRISMASOL BK 0/3.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
GASTROENTERO * GASTROENTERO LOGIC LLC OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN,

AMOXICILLIN

GAVIS PHARMS * GAVIS PHARMACEUTICALS LLC ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE, ACETAMINOPHEN ORPHENADRINE CITRATE, ORPHENADRINE CITRATE PENTAZOCINE AND NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE
QUINARETIC, HYDROCHLOROTHIAZIDE

TRIMETHOBENZAMIDE HYDROCHLORIDE, TRIMETHOBENZAMIDE HYDROCHLORIDE

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APPENDIX B
GD SEARLE * GD SEARLE LLC
CELEBREX, CELECOXIB

DAYPRO, OXAPROZIN

PRODUCT NAME SORTED BY APPLICANT

** G **

GD SEARLE LLC * GD SEARLE LLC ALDACTAZIDE, HYDROCHLOROTHIAZIDE ALDACTONE, SPIRONOLACTONE ARTHROTEC, DICLOFENAC SODIUM CALAN, VERAPAMIL HYDROCHLORIDE COVERA-HS, VERAPAMIL HYDROCHLORIDE CYTOTEC, MISOPROSTOL FLAGYL ER, METRONIDAZOLE FLAGYL, METRONIDAZOLE INSPRA, EPLERENONE LOMOTIL, ATROPINE SULFATE NORPACE CR, DISOPYRAMIDE PHOSPHATE
NORPACE, DISOPYRAMIDE PHOSPHATE

SYNAREL, NAFARELIN ACETATE
GE HEALTHCARE * GE HEALTHCARE ADREVIEW, IOBENGUANE SULFATE I-123 CERETEC, TECHNETIUM TC-99M EXAMETAZIME KIT CYSVIEW KIT, HEXAMINOLEVULINATE HYDROCHLORIDE INDICLOR, INDIUM IN-111 CHLORIDE INDIUM IN-111 OXYQUINOLINE, INDIUM IN-111 OXYQUINOLINE METASTRON, STRONTIUM CHLORIDE SR-89 MPI DMSA KIDNEY REAGENT, TECHNETIUM TC-99M SUCCIMER KIT MPI INDIUM DTPA IN 111, INDIUM IN-111 PENTETATE DISODIUM MYOVIEW 30ML, TECHNETIUM TC-99M TETROFOSMIN KIT MYOVIEW, TECHNETIUM TC-99M TETROFOSMIN KIT OMNIPAQUE 140, IOHEXOL OMNIPAQUE 180, IOHEXOL OMNIPAQUE 240, IOHEXOL OMNIPAQUE 300, IOHEXOL OMNIPAQUE 350, IOHEXOL OMNISCAN, GADODIAMIDE OPTISON, ALBUMIN HUMAN SODIUM IODIDE I 123, SODIUM IODIDE I-123 THALLOUS CHLORIDE TL 201, THALLOUS CHLORIDE TL-201
VISIPAQUE 270, IODIXANOL

VISIPAQUE 320, IODIXANOL
GE HLTHCARE INC * GE HEALTHCARE INC DATSCAN, IOFLUPANE I-123 GEDEON RICHTER USA * GEDEON RICHTER USA INC FINASTERIDE, FINASTERIDE GENENTECH * GENENTECH INC NUTROPIN AQ PEN, SOMATROPIN RECOMBINANT
NUTROPIN AQ, SOMATROPIN RECOMBINANT

NUTROPIN, SOMATROPIN RECOMBINANT
GENERAMEDIX * GENERAMEDIX INC SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE, GENTA * GENTA INC GANITE,

SODIUM FERRIC GLUCONATE COMPLEX

GALLIUM NITRATE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** G **

GENZYME * GENZYME CORP CEREDASE, ALGLUCERASE CEREZYME, IMIGLUCERASE CLOLAR, CLOFARABINE FLUDARA, FLUDARABINE PHOSPHATE MOZOBIL, PLERIXAFOR RENAGEL, SEVELAMER HYDROCHLORIDE
RENVELA, SEVELAMER CARBONATE

THYROGEN, THYROTROPIN ALFA
GENZYME CORP * GENZYME CORP HECTOROL, DOXERCALCIFEROL * GENZYME CORPORATION HECTOROL, DOXERCALCIFEROL GILEAD * GILEAD SCIENCES INC ATRIPLA, EFAVIRENZ CAYSTON, AZTREONAM EMTRIVA, EMTRICITABINE HEPSERA, ADEFOVIR DIPIVOXIL LETAIRIS, AMBRISENTAN RANEXA, RANOLAZINE TRUVADA, EMTRICITABINE
VIREAD, TENOFOVIR DISOPROXIL FUMARATE

VISTIDE, CIDOFOVIR
GILEAD SCIENCES INC * GILEAD SCIENCES INC COMPLERA, EMTRICITABINE GLAND PHARMA LTD * GLAND PHARMA LTD ADENOSINE, ADENOSINE AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE AZITHROMYCIN, AZITHROMYCIN HALOPERIDOL, HALOPERIDOL LACTATE
MILRINONE LACTATE, MILRINONE LACTATE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
GLAXO GRP LTD * GLAXO GROUP LTD HORIZANT, GABAPENTIN ENACARBIL * GLAXO GROUP LTD DBA GLAXOSMITHKLINE ALTABAX, RETAPAMULIN
FLOVENT HFA, FLUTICASONE PROPIONATE

SEREVENT, SALMETEROL XINAFOATE
GLAXOSMITHKLINE * GLAXOSMITHKLINE ABREVA, DOCOSANOL (OTC) ADVAIR DISKUS 100/50, FLUTICASONE PROPIONATE ADVAIR DISKUS 250/50, FLUTICASONE PROPIONATE ADVAIR DISKUS 500/50, FLUTICASONE PROPIONATE ADVAIR HFA, FLUTICASONE PROPIONATE ALKERAN, MELPHALAN ALKERAN, MELPHALAN HYDROCHLORIDE AMERGE, NARATRIPTAN HYDROCHLORIDE ARIXTRA, FONDAPARINUX SODIUM AVODART, DUTASTERIDE BACTROBAN, MUPIROCIN BACTROBAN, MUPIROCIN CALCIUM BECONASE AQ, BECLOMETHASONE DIPROPIONATE MONOHYDRATE
CEFTIN, CEFUROXIME AXETIL

EPIVIR-HBV, LAMIVUDINE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** G **

* GLAXOSMITHKLINE FLONASE, FLUTICASONE PROPIONATE FLOVENT DISKUS 100, FLUTICASONE PROPIONATE FLOVENT DISKUS 250, FLUTICASONE PROPIONATE FLOVENT DISKUS 50, FLUTICASONE PROPIONATE FORTAZ IN PLASTIC CONTAINER, CEFTAZIDIME SODIUM FORTAZ, CEFTAZIDIME HYCAMTIN, TOPOTECAN HYDROCHLORIDE IMITREX STATDOSE, SUMATRIPTAN SUCCINATE IMITREX, SUMATRIPTAN IMITREX, SUMATRIPTAN SUCCINATE JALYN, DUTASTERIDE LAMICTAL CD, LAMOTRIGINE LAMICTAL, LAMOTRIGINE MALARONE PEDIATRIC, ATOVAQUONE MALARONE, ATOVAQUONE NICORETTE (MINT), NICOTINE POLACRILEX (OTC) NICORETTE, NICOTINE POLACRILEX (OTC) PARNATE, TRANYLCYPROMINE SULFATE PAXIL CR, PAROXETINE HYDROCHLORIDE PAXIL, PAROXETINE HYDROCHLORIDE PROMACTA, ELTROMBOPAG OLAMINE PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE RELENZA, ZANAMIVIR REQUIP, ROPINIROLE HYDROCHLORIDE TAGAMET HB, CIMETIDINE (OTC) TAGAMET, CIMETIDINE THIOGUANINE, THIOGUANINE TIMENTIN IN PLASTIC CONTAINER, CLAVULANATE POTASSIUM TIMENTIN, CLAVULANATE POTASSIUM TREXIMET, NAPROXEN SODIUM VALTREX, VALACYCLOVIR HYDROCHLORIDE VENTOLIN HFA, ALBUTEROL SULFATE VERAMYST, FLUTICASONE FUROATE VOTRIENT, PAZOPANIB HYDROCHLORIDE WELLBUTRIN SR, BUPROPION HYDROCHLORIDE WELLBUTRIN, BUPROPION HYDROCHLORIDE ZANTAC 150, RANITIDINE HYDROCHLORIDE ZANTAC 25, RANITIDINE HYDROCHLORIDE ZANTAC 300, RANITIDINE HYDROCHLORIDE ZANTAC IN PLASTIC CONTAINER, RANITIDINE HYDROCHLORIDE ZANTAC, RANITIDINE HYDROCHLORIDE ZINACEF IN PLASTIC CONTAINER, CEFUROXIME SODIUM ZINACEF, CEFUROXIME SODIUM ZOFRAN ODT, ONDANSETRON ZOFRAN PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE ZOFRAN, ONDANSETRON HYDROCHLORIDE
ZOVIRAX, ACYCLOVIR

ZYBAN, BUPROPION HYDROCHLORIDE
GLAXOSMITHKLINE CONS * GLAXOSMITHKLINE CONSUMER HEALTHCARE ALLI, ORLISTAT (OTC)
COMMIT, NICOTINE POLACRILEX (OTC)

NICORETTE, NICOTINE POLACRILEX (OTC)
GLAXOSMITHKLINE LLC * GLAXOSMITHKLINE LLC DYAZIDE, HYDROCHLOROTHIAZIDE DYNACIRC CR, ISRADIPINE FLOLAN, EPOPROSTENOL SODIUM INNOPRAN XL, PROPRANOLOL HYDROCHLORIDE MEPRON, ATOVAQUONE
RYTHMOL SR, PROPAFENONE HYDROCHLORIDE

RYTHMOL, PROPAFENONE HYDROCHLORIDE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** G **

GLENMARK GENERICS * GLENMARK GENERICS INC USA ADAPALENE, ADAPALENE BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE CALCIPOTRIENE, CALCIPOTRIENE DIPYRIDAMOLE, DIPYRIDAMOLE MOMETASONE FUROATE, MOMETASONE FUROATE NILSTAT, NYSTATIN NIZATIDINE, NIZATIDINE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

ZONISAMIDE, ZONISAMIDE
* GLENMARK GENERICS LIMITED BRIELLYN, ETHINYL ESTRADIOL
FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE

LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE
* GLENMARK GENERICS LTD ALCLOMETASONE DIPROPIONATE, ALCLOMETASONE DIPROPIONATE ATOVAQUONE AND PROGUANIL HYDROCHLORIDE, ATOVAQUONE CARVEDILOL, CARVEDILOL CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE FELODIPINE, FELODIPINE FLUCONAZOLE, FLUCONAZOLE GABAPENTIN, GABAPENTIN HEATHER, NORETHINDRONE LAMOTRIGINE, LAMOTRIGINE LEVOFLOXACIN, LEVOFLOXACIN LITHIUM CARBONATE, LITHIUM CARBONATE MELOXICAM, MELOXICAM METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE MOEXIPRIL HYDROCHLORIDE, MOEXIPRIL HYDROCHLORIDE MOMETASONE FUROATE, MOMETASONE FUROATE NAPROXEN SODIUM, NAPROXEN SODIUM NAPROXEN, NAPROXEN NORETHIDRONE, NORETHINDRONE NORGESTIMATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE ONDANSETRON, ONDANSETRON OXCARBAZEPINE, OXCARBAZEPINE PRAVASTATIN SODIUM, PRAVASTATIN SODIUM ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE THEOPHYLLINE, THEOPHYLLINE TOPIRAMATE, TOPIRAMATE TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE, TRANDOLAPRIL TROSPIUM CHLORIDE, TROSPIUM CHLORIDE
URSODIOL, URSODIOL

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE
* GLENMARK GENERICS LTD INDIA INDOMETHACIN, INDOMETHACIN LITHIUM CARBONATE, LITHIUM CARBONATE
NORETHINDRONE ACETATE, NORETHINDRONE ACETATE

PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE
GLENMARK PHARMS * GLENMARK PHARMACEUTICALS INC USA CICLOPIROX, CICLOPIROX
CLOTRIMAZOLE, CLOTRIMAZOLE

MUPIROCIN, MUPIROCIN
* GLENMARK PHARMACEUTICALS LTD MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, GLENMARK PHARMS LTD * GLENMARK PHARMACEUTICALS LTD HYDRALAZINE HYDROCHLORIDE,

HYDROCHLOROTHIAZIDE

HYDRALAZINE HYDROCHLORIDE

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APPENDIX B
GRACEWAY * GRACEWAY PHARMACEUTICALS LLC
MINITRAN, NITROGLYCERIN

THEOLAIR, THEOPHYLLINE

PRODUCT NAME SORTED BY APPLICANT

** G **

GRANULES INDIA * GRANULES INDIA LTD IBUPROFEN, IBUPROFEN (OTC)

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)
GRIFFEN * KW GRIFFEN CO BIOSCRUB, CHLORHEXIDINE GLUCONATE GTX INC * GTX INC FARESTON,

(OTC)

TOREMIFENE CITRATE

GUARDIAN DRUG * GUARDIAN DRUG CO INC FOAMCOAT, ALUMINUM HYDROXIDE GUERBET * GUERBET LLC HEXABRIX, IOXAGLATE MEGLUMINE
OXILAN-300, IOXILAN

OXILAN-350, IOXILAN

(OTC)

HAEMONETICS * HAEMONETICS CORP SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HALOCARBON PRODS * HALOCARBON PRODUCTS CORP
ISOFLURANE, ISOFLURANE

SEVOFLURANE, SEVOFLURANE

SODIUM CHLORIDE

HALOZYME THERAP * HALOZYME THERAPEUTICS INC HYLENEX RECOMBINANT, HYALURONIDASE RECOMBINANT HUMAN HANFORD GC * GC HANFORD MANUFACTURING CO AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM
AMPICILLIN SODIUM, AMPICILLIN SODIUM

PENICILLIN G POTASSIUM, PENICILLIN G POTASSIUM
HARRIS PHARM * HARRIS PHARMACEUTICAL INC TERBINAFINE HYDROCHLORIDE, HEC PHARM INC * HEC PHARM INC ZIDOVUDINE,

TERBINAFINE HYDROCHLORIDE

ZIDOVUDINE

HELSINN HLTHCARE * HELSINN HEALTHCARE SA ALOXI, PALONOSETRON HYDROCHLORIDE HEMOFARM * HEMOFARM AD A-METHAPRED,

METHYLPREDNISOLONE SODIUM SUCCINATE

HERCON LABS * HERCON LABORATORIES CORP NITROGLYCERIN, NITROGLYCERIN HERITAGE PHARMS INC * HERITAGE PHARMACEUTICALS INC ACETAZOLAMIDE, ACETAZOLAMIDE
CARISOPRODOL AND ASPIRIN, ASPIRIN

DOXYCYCLINE, DOXYCYCLINE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** H **

* HERITAGE PHARMACEUTICALS INC GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE GLYBURIDE, GLYBURIDE HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE INDOMETHACIN, INDOMETHACIN KETOPROFEN, KETOPROFEN LEFLUNOMIDE, LEFLUNOMIDE NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE

PAROMOMYCIN SULFATE, PAROMOMYCIN SULFATE

HETERO DRUGS * HETERO DRUGS LTD METHOCARBAMOL, METHOCARBAMOL STAVUDINE, STAVUDINE

TORSEMIDE, TORSEMIDE

HETERO DRUGS LTD * HETERO DRUGS LTD UNIT III FINASTERIDE, FINASTERIDE LEVETIRACETAM, LEVETIRACETAM LITHIUM CARBONATE, LITHIUM CARBONATE

ZIDOVUDINE, ZIDOVUDINE

HETERO LABS UNIT III * HETERO LABS LTD UNIT III HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

INDOMETHACIN, INDOMETHACIN

HEYL CHEMISCH * HEYL CHEMISCH PHARMAZEUTISHE FABRIK RADIOGARDASE (PRUSSIAN BLUE), FERRIC HEXACYANOFERRATE(II) HH AND P * HH AND P LLC CROMOLYN SODIUM, CROMOLYN SODIUM FLUNISOLIDE, FLUNISOLIDE

(OTC)

HI TECH PHARMA * HI TECH PHARMACAL CO INC ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN ACYCLOVIR, ACYCLOVIR ALBUTEROL SULFATE, ALBUTEROL SULFATE AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE CALCIPOTRIENE, CALCIPOTRIENE CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE CICLOPIROX, CICLOPIROX CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE CORMAX, CLOBETASOL PROPIONATE DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE EMBELINE E, CLOBETASOL PROPIONATE EMBELINE, CLOBETASOL PROPIONATE ERYTHRO-STATIN, ERYTHROMYCIN FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE GABAPENTIN, GABAPENTIN HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE, HOMATROPINE METHYLBROMIDE HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE LACTULOSE, LACTULOSE LEVOCARNITINE, LEVOCARNITINE LEVOFLOXACIN, LEVOFLOXACIN LIDOCAINE AND PRILOCAINE, LIDOCAINE LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC)
MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE

MINOXIDIL (FOR MEN), MINOXIDIL (OTC)

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APPENDIX B
*

PRODUCT NAME SORTED BY APPLICANT

** H **

HI TECH PHARMACAL CO INC MINOXIDIL (FOR WOMEN), MINOXIDIL (OTC) NYSTATIN, NYSTATIN OFLOXACIN, OFLOXACIN PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE, PREDNISOLONE PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE, DEXTROMETHORPHAN HYDROBROMIDE
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE

TIMOLOL MALEATE, TIMOLOL MALEATE

VOSOL HC, ACETIC ACID, GLACIAL

VOSOL, ACETIC ACID, GLACIAL

HIGH TECH PHARMA * HIGH TECHNOLOGY PHARMACAL CO INC VALPROIC ACID, VALPROIC ACID HIKMA * HIKMA FARMACEUTICA LDA CEFOTAXIME, CEFOTAXIME SODIUM * HIKMA PHARMACEUTICALS AMOXICILLIN, AMOXICILLIN CARVEDILOL, CARVEDILOL CEFACLOR, CEFACLOR CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE CEPHALEXIN, CEPHALEXIN CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE GABAPENTIN, GABAPENTIN GLYBURIDE (MICRONIZED), GLYBURIDE
NAPROXEN SODIUM, NAPROXEN SODIUM

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
HIKMA FARMACEUTICA * HIKMA FARMACEUTICA (PORTUGAL) SA AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE BENZTROPINE MESYLATE, BENZTROPINE MESYLATE BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE CEFOXITIN, CEFOXITIN SODIUM CEFTRIAXONE, CEFTRIAXONE SODIUM CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN CIPROFLOXACIN, CIPROFLOXACIN CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE ENALAPRILAT, ENALAPRILAT FLUMAZENIL, FLUMAZENIL FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM GLYCOPYRROLATE, GLYCOPYRROLATE GRANISTERON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE LEVETIRACETAM, LEVETIRACETAM LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN METOPROLOL TARTRATE, METOPROLOL TARTRATE MILRINONE LACTATE IN PLASTIC CONTAINER, MILRINONE LACTATE MILRINONE LACTATE, MILRINONE LACTATE ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE PROGESTERONE, PROGESTERONE PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
TERBUTALINE SULFATE, TERBUTALINE SULFATE

VALPROATE SODIUM, VALPROATE SODIUM
* HIKMA FARMACEUTICA PORTUGAL LDA CEFAZOLIN SODIUM, CEFAZOLIN SODIUM
CEFUROXIME SODIUM, CEFUROXIME SODIUM

FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE

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APPENDIX B
* HIKMA FARMACEUTICA SA BUTORPHANOL TARTRATE,

PRODUCT NAME SORTED BY APPLICANT

** H **

BUTORPHANOL TARTRATE

HIKMA PHARMS * HIKMA PHARMACEUTICALS AMLODIPINE BESYLATE, AMLODIPINE BESYLATE AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN AMOXICILLIN, AMOXICILLIN CEPHALEXIN, CEPHALEXIN DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE GABAPENTIN, GABAPENTIN GEMFIBROZIL, GEMFIBROZIL LAMOTRIGINE, LAMOTRIGINE

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

HILL DERMAC * HILL DERMACEUTICALS INC DERMA-SMOOTHE/FS, FLUOCINOLONE ACETONIDE

DERMOTIC, FLUOCINOLONE ACETONIDE

HISAMITSU * HISAMITSU PHARMACEUTICAL CO INC SALONPAS, MENTHOL (OTC) HITECH PHARMA * HITECH PHARMACAL CORP CIPROFLOXACIN HYDROCHLORIDE,

CIPROFLOXACIN HYDROCHLORIDE

HI-TECH PHARMA CO * HI-TECH PHARMACAL CO INC TUSSICAPS, CHLORPHENIRAMINE POLISTIREX HOFFMANN LA ROCHE * HOFFMANN LA ROCHE INC INVIRASE, SAQUINAVIR MESYLATE ROCEPHIN, CEFTRIAXONE SODIUM ROMAZICON, FLUMAZENIL XELODA, CAPECITABINE XENICAL, ORLISTAT

ZELBORAF, VEMURAFENIB

HOPE PHARMS * HOPE PHARMACEUTICALS NITHIODOTE, SODIUM NITRITE HORIZON PHARMA * HORIZON PHARMA INC DUEXIS, FAMOTIDINE HOSPIRA * HOSPIRA INC ACETIC ACID 0.25% IN PLASTIC CONTAINER, ACETIC ACID, GLACIAL ACETYLCYSTEINE, ACETYLCYSTEINE A-HYDROCORT, HYDROCORTISONE SODIUM SUCCINATE ALFENTANIL, ALFENTANIL HYDROCHLORIDE A-METHAPRED, METHYLPREDNISOLONE SODIUM SUCCINATE AMIDATE, ETOMIDATE AMIKACIN SULFATE, AMIKACIN SULFATE AMINOCAPROIC ACID IN PLASTIC CONTAINER, AMINOCAPROIC ACID AMINOPHYLLINE, AMINOPHYLLINE AMINOSYN 10% (PH6), AMINO ACIDS AMINOSYN 10%, AMINO ACIDS AMINOSYN 3.5% M, AMINO ACIDS AMINOSYN 3.5%, AMINO ACIDS AMINOSYN 5%, AMINO ACIDS AMINOSYN 7% (PH6), AMINO ACIDS AMINOSYN 7% W/ ELECTROLYTES, AMINO ACIDS AMINOSYN 7%, AMINO ACIDS
AMINOSYN 8.5% (PH6), AMINO ACIDS
AMINOSYN 8.5% W/ ELECTROLYTES, AMINO ACIDS

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** H **

* HOSPIRA INC AMINOSYN 8.5%, AMINO ACIDS AMINOSYN II 10% IN PLASTIC CONTAINER, AMINO ACIDS AMINOSYN II 10% W/ ELECTROLYTES, AMINO ACIDS AMINOSYN II 10%, AMINO ACIDS AMINOSYN II 15% IN PLASTIC CONTAINER, AMINO ACIDS AMINOSYN II 7%, AMINO ACIDS AMINOSYN II 8.5% W/ ELECTROLYTES, AMINO ACIDS AMINOSYN II 8.5%, AMINO ACIDS AMINOSYN-HBC 7%, AMINO ACIDS AMINOSYN-HF 8%, AMINO ACIDS AMINOSYN-PF 10%, AMINO ACIDS AMINOSYN-PF 7%, AMINO ACIDS AMINOSYN-RF 5.2%, AMINO ACIDS AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE AMMONIUM CHLORIDE IN PLASTIC CONTAINER, AMMONIUM CHLORIDE AQUASOL A, VITAMIN A PALMITATE ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE, ARTICAINE HYDROCHLORIDE ATROPINE SULFATE ANSYR PLASTIC SYRINGE, ATROPINE SULFATE AZITHROMYCIN, AZITHROMYCIN BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION BLEOMYCIN SULFATE, BLEOMYCIN SULFATE BUMETANIDE, BUMETANIDE BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE, BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE W/EPINEPHRINE, BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE BUTORPHANOL TARTRATE PRESERVATIVE FREE, BUTORPHANOL TARTRATE CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER, CALCIUM CHLORIDE CARBOCAINE, MEPIVACAINE HYDROCHLORIDE CARBOPLATIN, CARBOPLATIN CHLOROPROCAINE HYDROCHLORIDE, CHLOROPROCAINE HYDROCHLORIDE CHROMIC CHLORIDE IN PLASTIC CONTAINER, CHROMIC CHLORIDE CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN CIPROFLOXACIN, CIPROFLOXACIN CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE CORLOPAM, FENOLDOPAM MESYLATE CUPRIC CHLORIDE IN PLASTIC CONTAINER, CUPRIC CHLORIDE CYTARABINE, CYTARABINE DACARBAZINE, DACARBAZINE DEFEROXAMINE MESYLATE, DEFEROXAMINE MESYLATE DEMEROL, MEPERIDINE HYDROCHLORIDE DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE DEXTROSE 10% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 20% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 25%, DEXTROSE DEXTROSE 30% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 40% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE DEXTROSE 5% AND RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 50% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 70% IN PLASTIC CONTAINER, DEXTROSE DIAZEPAM, DIAZEPAM DIGOXIN, DIGOXIN DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOBUTAMINE HYDROCHLORIDE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** H **

* HOSPIRA INC DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%, DOBUTAMINE HYDROCHLORIDE DOBUTAMINE HYDROCHLORIDE, DOBUTAMINE HYDROCHLORIDE DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOPAMINE HYDROCHLORIDE DOPAMINE HYDROCHLORIDE, DOPAMINE HYDROCHLORIDE DROPERIDOL, DROPERIDOL ENALAPRILAT, ENALAPRILAT EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE ERYC, ERYTHROMYCIN ERYTHROCIN, ERYTHROMYCIN LACTOBIONATE FENTANYL CITRATE PRESERVATIVE FREE, FENTANYL CITRATE FENTANYL CITRATE, FENTANYL CITRATE FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER, FLUCONAZOLE FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE FOSCARNET SODIUM, FOSCARNET SODIUM FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM FUROSEMIDE, FUROSEMIDE GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, GENTAMICIN SULFATE GENTAMICIN SULFATE, GENTAMICIN SULFATE GLYCINE 1.5% IN PLASTIC CONTAINER, GLYCINE HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN SODIUM HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, HEPARIN SODIUM HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN SODIUM HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, HEPARIN SODIUM HEPARIN SODIUM PRESERVATIVE FREE, HEPARIN SODIUM HEPARIN SODIUM, HEPARIN SODIUM HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE IONOSOL B AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE IONOSOL MB AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE ISOFLURANE, ISOFLURANE ISUPREL, ISOPROTERENOL HYDROCHLORIDE KETAMINE HYDROCHLORIDE, KETAMINE HYDROCHLORIDE KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE LEVOPHED, NOREPINEPHRINE BITARTRATE LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 0.8% IN DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 5% AND DEXTROSE 7.5%, LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE, EPINEPHRINE LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE LIPOSYN II 10%, SAFFLOWER OIL LIPOSYN II 20%, SAFFLOWER OIL LIPOSYN III 10%, SOYBEAN OIL LIPOSYN III 20%, SOYBEAN OIL LIPOSYN III 30%, SOYBEAN OIL
LORAZEPAM, LORAZEPAM

LTA II KIT, LIDOCAINE HYDROCHLORIDE
M.V.I. ADULT (PHARMACY BULK PACKAGE), ASCORBIC ACID M.V.I. ADULT, ASCORBIC ACID
M.V.I. PEDIATRIC, ASCORBIC ACID

M.V.I.-12 (WITHOUT VITAMIN K), ASCORBIC ACID

MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MAGNESIUM SULFATE

MAGNESIUM SULFATE IN PLASTIC CONTAINER, MAGNESIUM SULFATE

MAGNESIUM SULFATE, MAGNESIUM SULFATE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

B - 65

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** H **

* HOSPIRA INC MANGANESE CHLORIDE IN PLASTIC CONTAINER, MANGANESE CHLORIDE MANNITOL 10% IN PLASTIC CONTAINER, MANNITOL MANNITOL 15% IN PLASTIC CONTAINER, MANNITOL MANNITOL 20% IN PLASTIC CONTAINER, MANNITOL MANNITOL 25%, MANNITOL MANNITOL 5% IN PLASTIC CONTAINER, MANNITOL MARCAINE HYDROCHLORIDE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE MARCAINE HYDROCHLORIDE W/ EPINEPHRINE, BUPIVACAINE HYDROCHLORIDE MARCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE MARCAINE, BUPIVACAINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE, MEPERIDINE HYDROCHLORIDE METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM METHOTREXATE SODIUM, METHOTREXATE SODIUM METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE METOPROLOL TARTRATE, METOPROLOL TARTRATE METRONIDAZOLE IN PLASTIC CONTAINER, METRONIDAZOLE MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE, MIDAZOLAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MILRINONE LACTATE MORPHINE SULFATE, MORPHINE SULFATE NALBUPHINE HYDROCHLORIDE, NALBUPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE NITROGLYCERIN IN DEXTROSE 5%, NITROGLYCERIN NITROGLYCERIN, NITROGLYCERIN NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE NORMOSOL-R IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE PACLITAXEL, PACLITAXEL PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM PANCURONIUM BROMIDE, PANCURONIUM BROMIDE PHENYTOIN SODIUM, PHENYTOIN SODIUM PHYSIOSOL IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE PLEGISOL IN PLASTIC CONTAINER, CALCIUM CHLORIDE
POTASSIUM ACETATE IN PLASTIC CONTAINER, POTASSIUM ACETATE
POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, POTASSIUM

CHLORIDE
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER, DEXTROSE

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,
DEXTROSE

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
DEXTROSE

POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,
DEXTROSE

POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE

POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
DEXTROSE

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,
CALCIUM CHLORIDE

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER, DEXTROSE

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,
DEXTROSE

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

B - 66

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** H **

* HOSPIRA INC POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,
DEXTROSE

POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER,
DEXTROSE

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,
DEXTROSE

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
DEXTROSE

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
DEXTROSE

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,
CALCIUM CHLORIDE

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER,
DEXTROSE

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,
DEXTROSE

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
DEXTROSE

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
DEXTROSE

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER,
DEXTROSE

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,
DEXTROSE

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
DEXTROSE

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE, POTASSIUM CHLORIDE PRECEDEX, DEXMEDETOMIDINE HYDROCHLORIDE PROCAINAMIDE HYDROCHLORIDE, PROCAINAMIDE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE PROPOFOL, PROPOFOL QUELICIN PRESERVATIVE FREE, SUCCINYLCHOLINE CHLORIDE QUELICIN, SUCCINYLCHOLINE CHLORIDE RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE ROCURONIUM BROMIDE, ROCURONIUM BROMIDE SODIUM ACETATE IN PLASTIC CONTAINER, SODIUM ACETATE ANHYDROUS SODIUM BICARBONATE, SODIUM BICARBONATE SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, SODIUM CHLORIDE SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE SODIUM CHLORIDE IN PLASTIC CONTAINER, SODIUM CHLORIDE SODIUM LACTATE IN PLASTIC CONTAINER, SODIUM LACTATE SODIUM PHOSPHATES IN PLASTIC CONTAINER, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE SORBITOL-MANNITOL IN PLASTIC CONTAINER, MANNITOL STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION STERILE WATER IN PLASTIC CONTAINER, STERILE WATER FOR IRRIGATION SUFENTANIL CITRATE, SUFENTANIL CITRATE TALWIN, PENTAZOCINE LACTATE TAZICEF, CEFTAZIDIME THAM, TROMETHAMINE TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, TOBRAMYCIN SULFATE TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE TPN ELECTROLYTES IN PLASTIC CONTAINER, CALCIUM CHLORIDE TRIMETHOBENZAMIDE HYDROCHLORIDE, TRIMETHOBENZAMIDE HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

B - 67

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** H **

* HOSPIRA INC VECURONIUM BROMIDE, VECURONIUM BROMIDE VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE VINORELBINE TARTRATE, VINORELBINE TARTRATE VITAMIN K1, PHYTONADIONE

ZINC CHLORIDE IN PLASTIC CONTAINER, ZINC CHLORIDE

* HOSPIRA WORLDWIDE, INC DOBUTAMINE HYDROCHLORIDE, DOBUTAMINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE NITROPRESS, SODIUM NITROPRUSSIDE ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER, TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE

VINCRISTINE SULFATE PFS, VINCRISTINE SULFATE

ONDANSETRON HYDROCHLORIDE

HOSPIRA INC * HOSPIRA INC AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM CEFAZOLIN SODIUM, CEFAZOLIN SODIUM CEFEPIME HYDROCHLORIDE, CEFEPIME HYDROCHLORIDE CEFOTAXIME SODIUM, CEFOTAXIME SODIUM CEFOXITIN, CEFOXITIN SODIUM CEFTRIAXONE, CEFTRIAXONE SODIUM CEFUROXIME SODIUM, CEFUROXIME SODIUM DOCETAXEL, DOCETAXEL GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE GEMCITABINE, GEMCITABINE HYDROCHLORIDE HEPARIN SODIUM, HEPARIN SODIUM HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE IMIPENEM AND CILASTATIN, CILASTATIN SODIUM MAXIPIME, CEFEPIME HYDROCHLORIDE MEPIVACAINE HYDROCHLORIDE, MEPIVACAINE HYDROCHLORIDE MEROPENEM, MEROPENEM MORPHINE SULFATE, MORPHINE SULFATE NIPENT, PENTOSTATIN OXALIPLATIN, OXALIPLATIN PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE
TOPOTECAN, TOPOTECAN HYDROCHLORIDE

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE
HOSPIRA WORLDWIDE * HOSPIRA WORLDWIDE PTY OXALIPLATIN, OXALIPLATIN HQ SPECIALITY PHARMA * HQ SPECIALITY PHARMA LLC LEVETIRACETAM IN SODIUM CHLORIDE, HUAHAI US INC * HUAHAI US INC DONEPEZIL HYDROCHLORIDE,

LEVETIRACETAM

DONEPEZIL HYDROCHLORIDE

IBI * ISTITUTO BIOCHIMICO ITALIANO SPA

AMPICILLIN SODIUM, AMPICILLIN SODIUM

NAFCILLIN SODIUM, NAFCILLIN SODIUM
IDENTI PHARMS INC * IDENTI PHARMACEUTICALS INC FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE IMPAX LABS * IMPAX LABORATORIES INC ACARBOSE, ACARBOSE ALPRAZOLAM, ALPRAZOLAM ANAGRELIDE HYDROCHLORIDE,
BACLOFEN, BACLOFEN

ANAGRELIDE HYDROCHLORIDE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

B - 68

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** I **

* IMPAX LABORATORIES INC BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE CARBIDOPA AND LEVODOPA, CARBIDOPA CHLOROQUINE PHOSPHATE, CHLOROQUINE PHOSPHATE CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE COLESTIPOL HYDROCHLORIDE, COLESTIPOL HYDROCHLORIDE DANTROLENE SODIUM, DANTROLENE SODIUM DEMECLOCYCLINE HYDROCHLORIDE, DEMECLOCYCLINE HYDROCHLORIDE DIGOXIN, DIGOXIN DIPYRIDAMOLE, DIPYRIDAMOLE DIVALPROEX SODIUM, DIVALPROEX SODIUM FENOFIBRATE (MICRONIZED), FENOFIBRATE FENOFIBRATE, FENOFIBRATE FLUDROCORTISONE ACETATE, FLUDROCORTISONE ACETATE GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE LETROZOLE, LETROZOLE LORATADINE AND PSEUDOEPHEDRINE SULFATE, LORATADINE (OTC) LORATADINE, LORATADINE (OTC) METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE METHYLTESTOSTERONE, METHYLTESTOSTERONE MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE NADOLOL AND BENDROFLUMETHIAZIDE, BENDROFLUMETHIAZIDE OMEPRAZOLE, OMEPRAZOLE OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE PENTOXIFYLLINE, PENTOXIFYLLINE PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE PRIMIDONE, PRIMIDONE PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE PYRIDOSTIGMINE BROMIDE, PYRIDOSTIGMINE BROMIDE RILUZOLE, RILUZOLE RIMANTADINE HYDROCHLORIDE, RIMANTADINE HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE
TERBUTALINE SULFATE, TERBUTALINE SULFATE

TETRACYCLINE HYDROCHLORIDE, TETRACYCLINE HYDROCHLORIDE
IMPAX LABS INC * IMPAX LABORATORIES INC CABERGOLINE, CABERGOLINE DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
DOXYCYCLINE, DOXYCYCLINE

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE
IMPAX PHARMS * IMPAX PHARMACEUTICALS FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, FLAVOXATE HYDROCHLORIDE, FLAVOXATE HYDROCHLORIDE GEMFIBROZIL, GEMFIBROZIL MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE ORPHENADRINE CITRATE, ORPHENADRINE CITRATE
OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE
INALCO * INALCO SPA LACTULOSE,

FEXOFENADINE HYDROCHLORIDE

LACTULOSE

INCYTE CORP * INCYTE CORP JAKAFI, RUXOLITINIB PHOSPHATE INDICUS PHARMA * INDICUS PHARMA LLC
LETROZOLE, LETROZOLE
METFORMIN HYDROCHLORIDE,

METFORMIN HYDROCHLORIDE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

B - 69

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** I **

INNOPHARMA LLC * INNOPHARMA LLC

LEVETIRACETAM, LEVETIRACETAM

OLANZAPINE, OLANZAPINE
INO * INO THERAPEUTICS INC INOMAX, NITRIC OXIDE INSIGHT PHARMS * INSIGHT PHARMACEUTICALS CORP MONISTAT 1 COMBINATION PACK, MICONAZOLE MONISTAT 3 COMBINATION PACK (PREFILLED), MONISTAT 3 COMBINATION PACK, MICONAZOLE MONISTAT 3, MICONAZOLE NITRATE MONISTAT 3, MICONAZOLE NITRATE (OTC) MONISTAT 7 COMBINATION PACK, MICONAZOLE MONISTAT 7, MICONAZOLE NITRATE (OTC) MONISTAT-3 COMBINATION PACK, MICONAZOLE
NIX, PERMETHRIN (OTC)
INSPIRE * INSPIRE PHARMACEUTICALS INC AZASITE, AZITHROMYCIN INST BIOCHEM * INSTITUT BIOCHEMIQUE SA FLECTOR, DICLOFENAC EPOLAMINE INST BIOCHIMIQUE * INSTITUTE BIOCHIMIQUE SA (IBSA) TIROSINT, LEVOTHYROXINE SODIUM INSTITUT BIOCHIMIQUE * INSTITUT BIOCHIMIQUE SA IBSA TIROSINT, LEVOTHYROXINE SODIUM INSTITUTO BIOCHEMICO * INSTITUTO BIOCHEMICO ITALIANO SPA AMPICILLIN SODIUM, AMPICILLIN SODIUM
NAFCILLIN SODIUM, NAFCILLIN SODIUM

PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM
INSTITUTO BIOCHIMICO * INSTITUTO BIOCHIMICO ITALIANO SPA AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM INSYS THERAP * INSYS THERAPEUTICS INC DRONABINOL, DRONABINOL INTELGENX CORP * INTELGENX CORP FORFIVO XL, BUPROPION HYDROCHLORIDE INTENDIS * INTENDIS INC
DESONATE, DESONIDE

FINACEA, AZELAIC ACID
INTERGEL PHARM * INTERGEL PHARMACEUTICAL INC NIFEDIPINE, NIFEDIPINE INTL MEDICATED * INTERNATIONAL MEDICATED SYSTEMS LTD BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE
MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE

MILRINONE LACTATE, MILRINONE LACTATE

NITRATE (OTC) MICONAZOLE NITRATE NITRATE (OTC)

(OTC)

NITRATE NITRATE

(OTC)
(OTC)

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

B - 70

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** I **

INTL MEDICATION * INTERNATIONAL MEDICATION SYSTEM AMINOPHYLLINE, AMINOPHYLLINE DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE, DIPHENHYDRAMINE HYDROCHLORIDE FUROSEMIDE, FUROSEMIDE ISOPROTERENOL HYDROCHLORIDE, ISOPROTERENOL HYDROCHLORIDE LARYNG-O-JET KIT, LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE MANNITOL 25%, MANNITOL MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE, MEPERIDINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE PHYTONADIONE, PHYTONADIONE POTASSIUM CHLORIDE, POTASSIUM CHLORIDE
PROCAINAMIDE HYDROCHLORIDE, PROCAINAMIDE HYDROCHLORIDE

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE
* INTERNATIONAL MEDICATION SYSTEMS LTD
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE
INTL MEDICATION SYS * INTERNATIONAL MEDICATION SYSTEMS LTD LORAZEPAM, LORAZEPAM INVAGEN PHARMS * INVAGEN PHARMACEUTICALS INC AMLODIPINE BESYLATE, AMLODIPINE BESYLATE BENZTROPINE MESYLATE, BENZTROPINE MESYLATE CARBINOXAMINE MALEATE, CARBINOXAMINE MALEATE CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE FOLIC ACID, FOLIC ACID FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM FOSINOPRIL SODIUM, FOSINOPRIL SODIUM GABAPENTIN, GABAPENTIN GEMFIBROZIL, GEMFIBROZIL GLIMEPIRIDE, GLIMEPIRIDE HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE LEVETIRACETAM, LEVETIRACETAM MEPROBAMATE, MEPROBAMATE NABUMETONE, NABUMETONE NAPROXEN, NAPROXEN QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE RAMIPRIL, RAMIPRIL SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE TOPIRAMATE, TOPIRAMATE TRANDOLAPRIL, TRANDOLAPRIL WARFARIN SODIUM, WARFARIN SODIUM
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

ZONISAMIDE, ZONISAMIDE
INWOOD LABS * INWOOD LABORATORIES INC SUB FOREST LABORATORIES INC THEOPHYLLINE, THEOPHYLLINE IPCA LABS LTD * IPCA LABORATORIES LTD ALLOPURINOL, ALLOPURINOL ATENOLOL, ATENOLOL CHLOROQUINE PHOSPHATE, CHLOROQUINE PHOSPHATE FUROSEMIDE, FUROSEMIDE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** I **

* IPCA LABORATORIES LTD METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE METOPROLOL TARTRATE, METOPROLOL TARTRATE

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

IPR * IPR PHARMACEUTICALS INC ATENOLOL AND CHLORTHALIDONE, ATENOLOL ATENOLOL, ATENOLOL CRESTOR, ROSUVASTATIN CALCIUM

ZOMIG, ZOLMITRIPTAN

IPR PHARMS INC * IPR PHARMACEUTICALS INC VANDETANIB, VANDETANIB IPSEN PHARMS * IPSEN PHARMACEUTICALS INC SOMATULINE DEPOT, LANREOTIDE ACETATE IROKO PHARMS * IROKO PHARMACEUTICALS LLC INDOCIN, INDOMETHACIN ISO TEX * ISO TEX DIAGNOSTICS INC JEANATOPE, ALBUMIN IODINATED I-125 SERUM

MEGATOPE, ALBUMIN IODINATED I-131 SERUM

ISTA PHARMS * ISTA PHARMACEUTICALS BEPREVE, BEPOTASTINE BESILATE ISTALOL, TIMOLOL MALEATE

VITRASE, HYALURONIDASE

ISTA PHARMS INC * ISTA PHARMACEUTICALS INC BROMDAY, BROMFENAC SODIUM ISTITUTO BIOCHIMICO * ISTITUTO BIOCHIMICO ITALIANO GIOVANNI LORENZINI PIPERACILLIN, PIPERACILLIN SODIUM IVAX PHARMS * IVAX PHARMACEUTICALS INC PERINDOPRIL ERBUMINE, PERINDOPRIL ERBUMINE IVAX SUB TEVA PHARMS * IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE BACLOFEN, BACLOFEN BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE BUMETANIDE, BUMETANIDE CABERGOLINE, CABERGOLINE CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE (OTC)
CIMETIDINE, CIMETIDINE

CIMETIDINE, CIMETIDINE (OTC)

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

CLOZAPINE, CLOZAPINE

CYCLOSPORINE, CYCLOSPORINE

CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE

DIAZEPAM, DIAZEPAM

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

DOXYCYCLINE, DOXYCYCLINE

FAMOTIDINE, FAMOTIDINE

FAMOTIDINE, FAMOTIDINE (OTC)

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** I **

* IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA FENOPROFEN CALCIUM, FENOPROFEN CALCIUM FLUCONAZOLE, FLUCONAZOLE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE FLUTAMIDE, FLUTAMIDE FUROSEMIDE, FUROSEMIDE GABAPENTIN, GABAPENTIN GLIPIZIDE, GLIPIZIDE GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE GRISEOFULVIN, GRISEOFULVIN, MICROCRYSTALLINE GUANABENZ ACETATE, GUANABENZ ACETATE HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE INDAPAMIDE, INDAPAMIDE INDOMETHACIN, INDOMETHACIN LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LISINOPRIL, LISINOPRIL LORAZEPAM, LORAZEPAM METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE METHYLDOPA, METHYLDOPA MISOPROSTOL, MISOPROSTOL NADOLOL, NADOLOL NICOTINE POLACRILEX, NICOTINE POLACRILEX (OTC) NITROFURANTOIN, NITROFURANTOIN, MACROCRYSTALLINE OXAPROZIN, OXAPROZIN OXAZEPAM, OXAZEPAM PRAZOSIN HYDROCHLORIDE, PRAZOSIN HYDROCHLORIDE PROBENECID, PROBENECID RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC) SIMVASTATIN, SIMVASTATIN TERAZOSIN HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE TETRACYCLINE HYDROCHLORIDE, TETRACYCLINE HYDROCHLORIDE TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

JACOBUS * JACOBUS PHARMACEUTICAL CO DAPSONE, DAPSONE

PASER, AMINOSALICYLIC ACID

JANSSEN BIOTECH * JANSSEN BIOTECH INC ZYTIGA, ABIRATERONE ACETATE JANSSEN PHARMS * JANSSEN PHARMACEUTICALS INC AXERT, ALMOTRIPTAN MALATE CONCERTA, METHYLPHENIDATE HYDROCHLORIDE DITROPAN XL, OXYBUTYNIN CHLORIDE DITROPAN, OXYBUTYNIN CHLORIDE DORIBAX, DORIPENEM DURAGESIC-100, FENTANYL DURAGESIC-12, FENTANYL DURAGESIC-25, FENTANYL DURAGESIC-50, FENTANYL DURAGESIC-75, FENTANYL ELMIRON, PENTOSAN POLYSULFATE SODIUM HALDOL, HALOPERIDOL DECANOATE HALDOL, HALOPERIDOL LACTATE INVEGA SUSTENNA, PALIPERIDONE PALMITATE INVEGA, PALIPERIDONE LEUSTATIN, CLADRIBINE LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER,
LEVAQUIN, LEVOFLOXACIN

MICRONOR, NORETHINDRONE

LEVOFLOXACIN

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** J **

* JANSSEN PHARMACEUTICALS INC MODICON 28, ETHINYL ESTRADIOL NIZORAL, KETOCONAZOLE NUCYNTA ER, TAPENTADOL HYDROCHLORIDE NUCYNTA, TAPENTADOL HYDROCHLORIDE ORTHO CYCLEN-28, ETHINYL ESTRADIOL ORTHO EVRA, ETHINYL ESTRADIOL ORTHO TRI-CYCLEN LO, ETHINYL ESTRADIOL ORTHO TRI-CYCLEN, ETHINYL ESTRADIOL ORTHO-CEPT, DESOGESTREL ORTHO-NOVUM 1/35-28, ETHINYL ESTRADIOL ORTHO-NOVUM 7/7/7-28, ETHINYL ESTRADIOL PANCREAZE, LIPASE RAZADYNE ER, GALANTAMINE HYDROBROMIDE RAZADYNE, GALANTAMINE HYDROBROMIDE RISPERDAL CONSTA, RISPERIDONE RISPERDAL, RISPERIDONE SPORANOX, ITRACONAZOLE TERAZOL 3, TERCONAZOLE TERAZOL 7, TERCONAZOLE TOPAMAX, TOPIRAMATE TYLENOL W/ CODEINE NO. 3, ACETAMINOPHEN TYLENOL W/ CODEINE NO. 4, ACETAMINOPHEN TYLOX, ACETAMINOPHEN ULTRACET, ACETAMINOPHEN ULTRAM, TRAMADOL HYDROCHLORIDE

XARELTO, RIVAROXABAN

JANSSEN R AND D * JANSSEN RESEARCH AND DEVELOPMENT LLC FLEXERIL, CYCLOBENZAPRINE HYDROCHLORIDE

PARAFON FORTE DSC, CHLORZOXAZONE

JAZZ * JAZZ PHARMACEUTICALS LUVOX CR, FLUVOXAMINE MALEATE

XYREM, SODIUM OXYBATE

JHP PHARMS * JHP PHARMACEUTICALS LLC BREVITAL SODIUM, METHOHEXITAL SODIUM COLY-MYCIN M, COLISTIMETHATE SODIUM COLY-MYCIN S, COLISTIN SULFATE DANTRIUM, DANTROLENE SODIUM DELESTROGEN, ESTRADIOL VALERATE KETALAR, KETAMINE HYDROCHLORIDE PITOCIN, OXYTOCIN SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE TIGAN, TRIMETHOBENZAMIDE HYDROCHLORIDE

TRIOSTAT, LIOTHYRONINE SODIUM

JIANGSU HENGRUI MED * JIANGSU HENGRUI MEDICINE CO LTD IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE JOHN O BUTLER CO * JOHN O BUTLER CO CHLORHEXIDINE GLUCONATE,

CHLORHEXIDINE GLUCONATE

JOHNSON AND JOHNSON * JOHNSON AND JOHNSON GROUP CONSUMER COMPANIES MEN'S ROGAINE, MINOXIDIL (OTC) ROGAINE (FOR MEN), MINOXIDIL (OTC) ROGAINE (FOR WOMEN), MINOXIDIL (OTC) ROGAINE EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC) VISINE L.R., OXYMETAZOLINE HYDROCHLORIDE (OTC)
VISINE-A, NAPHAZOLINE HYDROCHLORIDE (OTC)

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** J **

JUBILANT CADISTA * JUBILANT CADISTA PHARMACEUTICALS INC CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE FOLIC ACID, FOLIC ACID HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE METHYLPREDNISOLONE, METHYLPREDNISOLONE PREDNISONE, PREDNISONE
PROCOMP, PROCHLORPERAZINE MALEATE

TERAZOSIN HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE
JUBILANT LIFE * JUBILANT LIFE SCIENCES LTD
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

LAMOTRIGINE, LAMOTRIGINE
JUBILANT ORGANOSYS * JUBILANT ORGANOSYS LTD
PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

RISPERIDONE, RISPERIDONE
KEY PHARMS * KEY PHARMACEUTICALS INC SUB SCHERING PLOUGH CORP NITRO-DUR, NITROGLYCERIN KIEL * KIEL LABORATORIES INC ORPHENADRINE CITRATE,

ORPHENADRINE CITRATE

KING PHARMS * KING PHARMACEUTICALS INC ALTACE, RAMIPRIL AVINZA, MORPHINE SULFATE BICILLIN C-R 900/300, PENICILLIN G BENZATHINE BICILLIN C-R, PENICILLIN G BENZATHINE BICILLIN L-A, PENICILLIN G BENZATHINE CORGARD, NADOLOL CORZIDE, BENDROFLUMETHIAZIDE CYTOMEL, LIOTHYRONINE SODIUM INTAL, CROMOLYN SODIUM LEVOXYL, LEVOTHYROXINE SODIUM PENICILLIN G PROCAINE, PENICILLIN G PROCAINE SILVADENE, SILVER SULFADIAZINE SKELAXIN, METAXALONE
SYNERCID, DALFOPRISTIN

TIGAN, TRIMETHOBENZAMIDE HYDROCHLORIDE
* KING PHARMACEUTICALS RESEARCH AND DEVELOPMENT INC SUB KING PHARMACEUTICALS INC SONATA, ZALEPLON
TAPAZOLE, METHIMAZOLE

TUSSIGON, HOMATROPINE METHYLBROMIDE
KING PHARMS R AND D * KING PHARMACEUTICALS RESEARCH DEVELOPMENT INC OXECTA, OXYCODONE HYDROCHLORIDE KOWA CO * KOWA CO LTD LIVALO, PITAVASTATIN CALCIUM KREMERS URBAN PHARMS * KREMERS URBAN PHARMACEUTICALS INC GLYCOLAX, POLYETHYLENE GLYCOL 3350 GLYCOLAX, POLYETHYLENE GLYCOL 3350 (OTC) ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE
NITROGLYCERIN, NITROGLYCERIN

OMEPRAZOLE, OMEPRAZOLE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** K **

KUDCO IRELAND * KUDCO IRELAND LTD ANASTROZOLE, ANASTROZOLE BICALUTAMIDE, BICALUTAMIDE

LETROZOLE, LETROZOLE

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM
KV PHARM * KV PHARMACEUTICAL CO CLINDESSE, CLINDAMYCIN PHOSPHATE EVAMIST, ESTRADIOL
GYNAZOLE-1, BUTOCONAZOLE NITRATE

MAKENA, HYDROXYPROGESTERONE CAPROATE
KVK TECH * KVK TECH INC BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE KALEXATE, SODIUM POLYSTYRENE SULFONATE PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE
PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
LAB HRA PHARMA * LABORATOIRE HRA PHARMA ELLA, ULIPRISTAL ACETATE LANDELA PHARM * LANDELA PHARMACEUTICAL ALBUTEROL SULFATE, ALBUTEROL SULFATE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE
LANNETT * LANNETT CO INC ACETAZOLAMIDE, ACETAZOLAMIDE DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE LANORINAL, ASPIRIN PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE PRIMIDONE, PRIMIDONE
PROBALAN, PROBENECID

SERPALAN, RESERPINE
* LANNETT HOLDINGS INC BACLOFEN, BACLOFEN BENZTROPINE MESYLATE, BENZTROPINE MESYLATE BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE DANAZOL, DANAZOL DIPYRIDAMOLE, DIPYRIDAMOLE DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE DOXYCYCLINE, DOXYCYCLINE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE RIFAMPIN, RIFAMPIN
TERBUTALINE SULFATE, TERBUTALINE SULFATE

URSODIOL, URSODIOL

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** L **

LANNETT HOLDINGS INC * LANNETT HOLDINGS INC DIETHYLPROPION HYDROCHLORIDE, DIETHYLPROPION HYDROCHLORIDE LOXAPINE SUCCINATE, LOXAPINE SUCCINATE METHOCARBAMOL, METHOCARBAMOL MORPHINE SULFATE, MORPHINE SULFATE PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE PHENTERMINE RESIN COMPLEX, PHENTERMINE RESIN COMPLEX
TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LANTHEUS MEDCL * LANTHEUS MEDICAL IMAGING INC ABLAVAR, GADOFOSVESET TRISODIUM CARDIOLITE, TECHNETIUM TC-99M SESTAMIBI KIT DEFINITY, PERFLUTREN GALLIUM CITRATE GA 67, GALLIUM CITRATE GA-67 NEUROLITE, TECHNETIUM TC-99M BICISATE KIT TECHNELITE, TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR THALLOUS CHLORIDE TL 201, THALLOUS CHLORIDE TL-201
XENON XE 133, XENON XE-133
LAVIPHARM LABS * LAVIPHARM LABORATORIES INC FENTANYL-100, FENTANYL FENTANYL-25, FENTANYL FENTANYL-50, FENTANYL
FENTANYL-75, FENTANYL
LEHIGH VALLEY * LEHIGH VALLEY TECHNOLOGIES INC OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE LEK PHARMS * LEK PHARMACEUTICALS D D AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN BROMOCRIPTINE MESYLATE, BROMOCRIPTINE MESYLATE ENALAPRIL MALEATE, ENALAPRIL MALEATE LISINOPRIL, LISINOPRIL
OMEPRAZOLE, OMEPRAZOLE
LEK PHARMS DD * LEK PHARMACEUTICALS DD AMLODIPINE BESYLATE, AMLODIPINE BESYLATE AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN PRAVASTATIN SODIUM, PRAVASTATIN SODIUM
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
LEO PHARM * LEO PHARMACEUTICAL PRODUCTS LTD DOVONEX, CALCIPOTRIENE
TACLONEX, BETAMETHASONE DIPROPIONATE
LEO PHARM PRODS * LEO PHARMACEUTICAL PRODUCTS LTD TACLONEX SCALP, BETAMETHASONE DIPROPIONATE LEO PHARMA AS * LEO PHARMA AS INNOHEP, TINZAPARIN SODIUM LG LIFE * LG LIFE SCIENCES LTD VALTROPIN, SOMATROPIN RECOMBINANT LILLY * ELI LILLY AND CO ALIMTA, PEMETREXED DISODIUM CIALIS, TADALAFIL CYMBALTA, DULOXETINE HYDROCHLORIDE
EVISTA, RALOXIFENE HYDROCHLORIDE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** L **

* ELI LILLY AND CO FORTEO, TERIPARATIDE RECOMBINANT HUMAN GEMZAR, GEMCITABINE HYDROCHLORIDE GLUCAGON, GLUCAGON RECOMBINANT HUMALOG KWIKPEN, INSULIN LISPRO RECOMBINANT HUMALOG MIX 50/50 KWIKPEN, INSULIN LISPRO PROTAMINE RECOMBINANT HUMALOG MIX 50/50 PEN, INSULIN LISPRO PROTAMINE RECOMBINANT HUMALOG MIX 50/50, INSULIN LISPRO PROTAMINE RECOMBINANT HUMALOG MIX 75/25 KWIKPEN, INSULIN LISPRO PROTAMINE RECOMBINANT HUMALOG MIX 75/25 PEN, INSULIN LISPRO PROTAMINE RECOMBINANT HUMALOG MIX 75/25, INSULIN LISPRO PROTAMINE RECOMBINANT HUMALOG PEN, INSULIN LISPRO RECOMBINANT HUMALOG, INSULIN LISPRO RECOMBINANT HUMATROPE, SOMATROPIN RECOMBINANT HUMULIN 70/30 PEN, INSULIN RECOMBINANT HUMAN (OTC) HUMULIN 70/30, INSULIN RECOMBINANT HUMAN (OTC) HUMULIN N, INSULIN SUSP ISOPHANE RECOMBINANT HUMAN (OTC) HUMULIN R PEN, INSULIN RECOMBINANT HUMAN (OTC) HUMULIN R, INSULIN RECOMBINANT HUMAN HUMULIN R, INSULIN RECOMBINANT HUMAN (OTC) PROZAC WEEKLY, FLUOXETINE HYDROCHLORIDE QUINIDINE GLUCONATE, QUINIDINE GLUCONATE STRATTERA, ATOMOXETINE HYDROCHLORIDE SYMBYAX, FLUOXETINE HYDROCHLORIDE ZYPREXA ZYDIS, OLANZAPINE

ZYPREXA, OLANZAPINE

* LILLY RESEARCH LABORATORIES DIV ELI LILLY AND CO PROZAC, FLUOXETINE HYDROCHLORIDE

SARAFEM, FLUOXETINE HYDROCHLORIDE

LLOYD * LLOYD INC LEVOTHROID,

LEVOTHYROXINE SODIUM

LNK * LNK INTERNATIONAL INC DOXYLAMINE SUCCINATE, DOXYLAMINE SUCCINATE (OTC) IBUPROFEN, IBUPROFEN (OTC)

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE LOREAL USA * LOREAL USA PRODUCTS INC ANTHELIOS 20, AVOBENZONE (OTC) ANTHELIOS 40, AVOBENZONE (OTC) ANTHELIOS SX, AVOBENZONE (OTC)

CAPITAL SOLEIL 15, AVOBENZONE (OTC)

(OTC)

LUITPOLD * LUITPOLD PHARMACEUTICALS INC ACETYLCYSTEINE, ACETYLCYSTEINE ADENOSINE, ADENOSINE AMINOCAPROIC ACID, AMINOCAPROIC ACID AMINOPHYLLINE, AMINOPHYLLINE BENZTROPINE MESYLATE, BENZTROPINE MESYLATE BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE CAFFEINE CITRATE, CAFFEINE CITRATE CALCITRIOL, CALCITRIOL CEFTRIAXONE, CEFTRIAXONE SODIUM CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE CYANOCOBALAMIN, CYANOCOBALAMIN CYCLOSPORINE, CYCLOSPORINE DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE DEXFERRUM, IRON DEXTRAN DOPAMINE HYDROCHLORIDE, DOPAMINE HYDROCHLORIDE

DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** L **

* LUITPOLD PHARMACEUTICALS INC DROPERIDOL, DROPERIDOL ESTRADIOL VALERATE, ESTRADIOL VALERATE ETOMIDATE, ETOMIDATE FOMEPIZOLE, FOMEPIZOLE FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM FUROSEMIDE, FUROSEMIDE GLYCOPYRROLATE, GLYCOPYRROLATE GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE IBUTILIDE FUMARATE, IBUTILIDE FUMARATE KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE LATANOPROST, LATANOPROST LEUCOVORIN CALCIUM PRESERVATIVE FREE, LEUCOVORIN CALCIUM LEVOCARNITINE, LEVOCARNITINE LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE MANNITOL 25%, MANNITOL METHYLDOPATE HYDROCHLORIDE, METHYLDOPATE HYDROCHLORIDE METHYLERGONOVINE MALEATE, METHYLERGONOVINE MALEATE METOPROLOL TARTRATE, METOPROLOL TARTRATE NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN, GRAMICIDIN NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE, HYDROCORTISONE NITROGLYCERIN, NITROGLYCERIN ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM PHENYTOIN SODIUM, PHENYTOIN SODIUM PROGESTERONE, PROGESTERONE PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE SPRIX, KETOROLAC TROMETHAMINE TORSEMIDE, TORSEMIDE TRIMETHOBENZAMIDE HYDROCHLORIDE PRESERVATIVE FREE, TRIMETHOBENZAMIDE HYDROCHLORIDE TRIMETHOBENZAMIDE HYDROCHLORIDE, TRIMETHOBENZAMIDE HYDROCHLORIDE
VENOFER, IRON SUCROSE

ZIDOVUDINE, ZIDOVUDINE
LUNDBECK INC * LUNDBECK INC CHEMET, SUCCIMER COGENTIN, BENZTROPINE MESYLATE COSMEGEN, DACTINOMYCIN DESOXYN, METHAMPHETAMINE HYDROCHLORIDE DIURIL, CHLOROTHIAZIDE SODIUM INDOCIN, INDOMETHACIN SODIUM MUSTARGEN, MECHLORETHAMINE HYDROCHLORIDE NEMBUTAL SODIUM, PENTOBARBITAL SODIUM NEOPROFEN, IBUPROFEN LYSINE ONFI, CLOBAZAM PEGANONE, ETHOTOIN
SABRIL, VIGABATRIN

TRANXENE, CLORAZEPATE DIPOTASSIUM
LUPIN * LUPIN LTD AMLODIPINE BESYLATE, AMLODIPINE BESYLATE CARVEDILOL, CARVEDILOL CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE CEFDINIR, CEFDINIR CEFOTAXIME SODIUM, CEFOTAXIME SODIUM CEFPROZIL, CEFPROZIL CEFTRIAXONE, CEFTRIAXONE SODIUM CEFUROXIME AXETIL, CEFUROXIME AXETIL
CEPHALEXIN, CEPHALEXIN

DIVALPROEX SODIUM, DIVALPROEX SODIUM

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B - 79

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** L **

* LUPIN LTD ETHAMBUTOL HYDROCHLORIDE, ETHAMBUTOL HYDROCHLORIDE LEVETIRACETAM, LEVETIRACETAM LEVOFLOXACIN, LEVOFLOXACIN LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LISINOPRIL, LISINOPRIL LOVASTATIN, LOVASTATIN QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE RAMIPRIL, RAMIPRIL SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE SIMVASTATIN, SIMVASTATIN

TRANDOLAPRIL, TRANDOLAPRIL

LUPIN ATLANTIS * LUPIN ATLANTIS HOLDINGS SA ANTARA (MICRONIZED), FENOFIBRATE LUPIN LTD * LUPIN LIMITED LEVETIRACETAM, LEVETIRACETAM

LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

* LUPIN LTD FAMOTIDINE, FAMOTIDINE FENOFIBRATE, FENOFIBRATE IMIPRAMINE HYDROCHLORIDE, IMIPRAMINE HYDROCHLORIDE IMIPRAMINE PAMOATE, IMIPRAMINE PAMOATE LAMOTRIGINE, LAMOTRIGINE LEVETIRACETAM, LEVETIRACETAM LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM, LOSARTAN POTASSIUM MEFENAMIC ACID, MEFENAMIC ACID METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE NABUMETONE, NABUMETONE NORETHINDRONE, NORETHINDRONE PERINDOPRIL ERBUMINE, PERINDOPRIL ERBUMINE
SUPRAX, CEFIXIME

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
LUPIN PHARMS * LUPIN PHARMACEUTICALS INC AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, DESLORATADINE, DESLORATADINE MELOXICAM, MELOXICAM
PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

SUPRAX, CEFIXIME

AMLODIPINE BESYLATE

LYNE * LYNE LABORATORIES INC CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE DEXAMETHASONE, DEXAMETHASONE HYDROCORTISONE, HYDROCORTISONE
LEVOCARNITINE, LEVOCARNITINE

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE
LYNROSE LABS * LYNROSE LABS LLC CARBINOXAMINE MALEATE,

CARBINOXAMINE MALEATE

MALLINCKRODT * MALLINCKRODT CHEMICAL INC ANEXSIA 7.5/650, ACETAMINOPHEN ANEXSIA, ACETAMINOPHEN BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN
METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE

METHADOSE, METHADONE HYDROCHLORIDE

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B - 80

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** M **

* MALLINCKRODT CHEMICAL INC OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN * MALLINCKRODT INC ANEXSIA 5/325, ACETAMINOPHEN ANEXSIA 7.5/325, ACETAMINOPHEN ANEXSIA, ACETAMINOPHEN DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE FENTANYL CITRATE, FENTANYL CITRATE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE METHYLIN ER, METHYLPHENIDATE HYDROCHLORIDE METHYLIN, METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE MORPHINE SULFATE, MORPHINE SULFATE NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE OPTIMARK IN PLASTIC CONTAINER, GADOVERSETAMIDE OPTIMARK, GADOVERSETAMIDE OXYCET, ACETAMINOPHEN OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE PENNSAID, DICLOFENAC SODIUM SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE TECHNETIUM TC-99 SESTAMIBI, TECHNETIUM TC-99M SESTAMIBI KIT THALLOUS CHLORIDE TL 201, THALLOUS CHLORIDE TL-201

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

* MALLINCKRODT MEDICAL INC CONRAY 30, IOTHALAMATE MEGLUMINE CONRAY 43, IOTHALAMATE MEGLUMINE CONRAY, IOTHALAMATE MEGLUMINE CYSTO-CONRAY II, IOTHALAMATE MEGLUMINE GALLIUM CITRATE GA 67, GALLIUM CITRATE GA-67 INDIUM IN 111 CHLORIDE, INDIUM IN-111 CHLORIDE MD-76R, DIATRIZOATE MEGLUMINE MD-GASTROVIEW, DIATRIZOATE MEGLUMINE OCTREOSCAN, INDIUM IN-111 PENTETREOTIDE KIT OPTIRAY 240, IOVERSOL OPTIRAY 300, IOVERSOL OPTIRAY 320, IOVERSOL OPTIRAY 350, IOVERSOL SODIUM IODIDE I 123, SODIUM IODIDE I-123 SODIUM IODIDE I 131, SODIUM IODIDE I-131 TECHNESCAN MAG3, TECHNETIUM TC-99M MERTIATIDE KIT TECHNESCAN PYP KIT, TECHNETIUM TC-99M PYROPHOSPHATE KIT TECHNESCAN, TECHNETIUM TC-99M OXIDRONATE KIT THALLOUS CHLORIDE TL 201, THALLOUS CHLORIDE TL-201 ULTRATAG, TECHNETIUM TC-99M RED BLOOD CELL KIT
ULTRA-TECHNEKOW FM, TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR
MALLINCKRODT INC * MALLINCKRODT INC ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE EXALGO, HYDROMORPHONE HYDROCHLORIDE FENTANYL-100, FENTANYL FENTANYL-25, FENTANYL FENTANYL-50, FENTANYL FENTANYL-75, FENTANYL HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE MORPHINE SULFATE, MORPHINE SULFATE OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
RESTORIL, TEMAZEPAM

TOFRANIL, IMIPRAMINE HYDROCHLORIDE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

B - 81

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** M **

* MALLINCKRODT INC TOFRANIL-PM, IMIPRAMINE PAMOATE MALLINCKRODT LLC * MALLINCKRODT LLC ANAFRANIL, CLOMIPRAMINE HYDROCHLORIDE

PAMELOR, NORTRIPTYLINE HYDROCHLORIDE

MARATHON PHARMS * MARATHON PHARMACEUTICALS LLC SECONAL SODIUM, SECOBARBITAL SODIUM MARKSANS PHARMA * MARKSANS PHARMA LTD GABAPENTIN, GABAPENTIN IBUPROFEN, IBUPROFEN IBUPROFEN, IBUPROFEN (OTC) NAPROXEN SODIUM, NAPROXEN SODIUM NAPROXEN, NAPROXEN

(OTC)

MARSAM PHARMS LLC * MARSAM PHARMACEUTICALS LLC TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE MATRIX LABS LTD * MATRIX LABORATORIES LTD AMLODIPINE BESYLATE, AMLODIPINE BESYLATE BACLOFEN, BACLOFEN CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE DIDANOSINE, DIDANOSINE DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE GABAPENTIN, GABAPENTIN LANSOPRAZOLE, LANSOPRAZOLE MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE NABUMETONE, NABUMETONE NIFEDIPINE, NIFEDIPINE PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM PRAVASTATIN SODIUM, PRAVASTATIN SODIUM RAMIPRIL, RAMIPRIL SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE SIMVASTATIN, SIMVASTATIN STAVUDINE, STAVUDINE TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE
VORICONAZOLE, VORICONAZOLE

ZIDOVUDINE, ZIDOVUDINE
MAYNE PHARMA * MAYNE PHARMA INTERNATIONAL PTY LTD DORYX, DOXYCYCLINE HYCLATE MCNEIL * MCNEIL CONSUMER PRODUCTS CO DIV MCNEILAB INC CHILDREN'S MOTRIN, IBUPROFEN (OTC) IBUPROFEN, IBUPROFEN (OTC) IMODIUM A-D EZ CHEWS, LOPERAMIDE HYDROCHLORIDE (OTC) IMODIUM MULTI-SYMPTOM RELIEF, LOPERAMIDE HYDROCHLORIDE MOTRIN IB, IBUPROFEN (OTC)
MOTRIN MIGRAINE PAIN, IBUPROFEN (OTC)

ZYRTEC-D 12 HOUR, CETIRIZINE HYDROCHLORIDE (OTC)

(OTC)

MCNEIL CONS * MCNEIL CONSUMER HEALTHCARE BENADRYL PRESERVATIVE FREE, DIPHENHYDRAMINE HYDROCHLORIDE BENADRYL, DIPHENHYDRAMINE HYDROCHLORIDE CHILDREN'S MOTRIN COLD, IBUPROFEN (OTC) CHILDREN'S MOTRIN, IBUPROFEN (OTC) IMODIUM A-D, LOPERAMIDE HYDROCHLORIDE (OTC)

IMODIUM MULTI-SYMPTOM RELIEF, LOPERAMIDE HYDROCHLORIDE (OTC)

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** M **

* MCNEIL CONSUMER HEALTHCARE IMODIUM, LOPERAMIDE HYDROCHLORIDE JUNIOR STRENGTH MOTRIN, IBUPROFEN (OTC) NIZORAL A-D, KETOCONAZOLE (OTC) SINE-AID IB, IBUPROFEN (OTC) SUDAFED 12 HOUR, PSEUDOEPHEDRINE HYDROCHLORIDE SUDAFED 24 HOUR, PSEUDOEPHEDRINE HYDROCHLORIDE TYLENOL (CAPLET), ACETAMINOPHEN (OTC)

TYLENOL (GELTAB), ACETAMINOPHEN (OTC)

(OTC) (OTC)

MCNEIL CONSUMER * MCNEIL CONSUMER HEALTHCARE DIV MCNEIL PPC INC CHILDREN'S ZYRTEC ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CHILDREN'S ZYRTEC HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) ZYRTEC ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) ZYRTEC HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)

ZYRTEC, CETIRIZINE HYDROCHLORIDE

MEAD JOHNSON * MEAD JOHNSON AND CO CAFCIT, CAFFEINE CITRATE MEDA PHARMS * MEDA PHARMACEUTICALS EDLUAR, ZOLPIDEM TARTRATE * MEDA PHARMACEUTICALS INC ANADROL-50, OXYMETHOLONE ASTELIN, AZELASTINE HYDROCHLORIDE ASTEPRO, AZELASTINE HYDROCHLORIDE BUTISOL SODIUM, BUTABARBITAL SODIUM CESAMET, NABILONE COLYTE WITH FLAVOR PACKS, POLYETHYLENE GLYCOL 3350 COLYTE, POLYETHYLENE GLYCOL 3350 COLYTE-FLAVORED, POLYETHYLENE GLYCOL 3350 CORTIFOAM, HYDROCORTISONE ACETATE DEMADEX, TORSEMIDE DEPEN, PENICILLAMINE DIPENTUM, OLSALAZINE SODIUM EPIFOAM, HYDROCORTISONE ACETATE FELBATOL, FELBAMATE LUFYLLIN, DYPHYLLINE MUSE, ALPROSTADIL ONSOLIS, FENTANYL CITRATE OPTIVAR, AZELASTINE HYDROCHLORIDE PROCTOFOAM HC, HYDROCORTISONE ACETATE ROWASA, MESALAMINE
SFROWASA, MESALAMINE

TRILYTE, POLYETHYLENE GLYCOL 3350
* MEDA PHARMACEUTICALS MEDA PHARMACEUTICALS INC SOMA COMPOUND W/ CODEINE, ASPIRIN
SOMA COMPOUND, ASPIRIN

SOMA, CARISOPRODOL
MEDICINES CO * THE MEDICINES CO
ANGIOMAX, BIVALIRUDIN

CLEVIPREX, CLEVIDIPINE BUTYRATE
MEDICIS * MEDICIS PHARMACEUTICAL CORP ALDARA, IMIQUIMOD BUPHENYL, SODIUM PHENYLBUTYRATE CALCIUM DISODIUM VERSENATE, EDETATE CALCIUM DISODIUM DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE DYNACIN, MINOCYCLINE HYDROCHLORIDE ESTRASORB, ESTRADIOL HEMIHYDRATE

LIDEX, FLUOCINONIDE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

B - 83

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** M **

* MEDICIS PHARMACEUTICAL CORP LIDEX-E, FLUOCINONIDE LOPROX, CICLOPIROX MAXAIR, PIRBUTEROL ACETATE METROGEL-VAGINAL, METRONIDAZOLE NORFLEX, ORPHENADRINE CITRATE NORGESIC FORTE, ASPIRIN NORGESIC, ASPIRIN SOLODYN, MINOCYCLINE HYDROCHLORIDE SYNACORT, HYDROCORTISONE TAMBOCOR, FLECAINIDE ACETATE VANOS, FLUOCINONIDE ZIANA, CLINDAMYCIN PHOSPHATE

ZYCLARA, IMIQUIMOD

MEDICURE * MEDICURE INTERNATIONAL INC AGGRASTAT, TIROFIBAN HYDROCHLORIDE MEDIGENE AG * MEDIGENE AG VEREGEN, SINECATECHINS MEDIMETRIKS PHARMS * MEDIMETRIKS PHARMACEUTICALS INC SYNALAR, FLUOCINOLONE ACETONIDE MEDIMMUNE * MEDIMMUNE ETHYOL,

AMIFOSTINE

MEDTRONIC * MEDTRONIC INC LIORESAL, BACLOFEN MERCK * MERCK AND CO INC AMINOHIPPURATE SODIUM, AMINOHIPPURATE SODIUM CANCIDAS, CASPOFUNGIN ACETATE EMEND, APREPITANT FOSAMAX PLUS D, ALENDRONATE SODIUM FOSAMAX, ALENDRONATE SODIUM HYZAAR, HYDROCHLOROTHIAZIDE INVANZ, ERTAPENEM SODIUM JANUMET, METFORMIN HYDROCHLORIDE MAXALT, RIZATRIPTAN BENZOATE MAXALT-MLT, RIZATRIPTAN BENZOATE PRIMAXIN, CILASTATIN SODIUM PROSCAR, FINASTERIDE SINGULAIR, MONTELUKAST SODIUM
STROMECTOL, IVERMECTIN

ZOLINZA, VORINOSTAT
* MERCK RESEARCH LABORATORIES DIV MERCK CO INC CLINORIL, SULINDAC COSOPT, DORZOLAMIDE HYDROCHLORIDE COZAAR, LOSARTAN POTASSIUM MEVACOR, LOVASTATIN NOROXIN, NORFLOXACIN PEPCID, FAMOTIDINE PRINIVIL, LISINOPRIL PRINZIDE, HYDROCHLOROTHIAZIDE PROPECIA, FINASTERIDE SINGULAIR, MONTELUKAST SODIUM
TRUSOPT, DORZOLAMIDE HYDROCHLORIDE

ZOCOR, SIMVASTATIN

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

B - 84

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** M **

MERCK AND CO INC * MERCK AND CO INC

EMEND, FOSAPREPITANT DIMEGLUMINE

FOSAMAX, ALENDRONATE SODIUM
MERCK CO INC * MERCK CO INC JANUVIA, SITAGLIPTIN PHOSPHATE MERCK KGAA * MERCK KGAA LEVOTHYROXINE SODIUM,

LEVOTHYROXINE SODIUM

MERCK SANTE SAS * MERCK SANTE SAS CYANOKIT, HYDROXOCOBALAMIN MERCK SHARP DOHME * MERCK SHARP AND DOHME CORP CRIXIVAN, INDINAVIR SULFATE ISENTRESS, RALTEGRAVIR POTASSIUM JUVISYNC, SIMVASTATIN PEPCID AC (GELTAB), FAMOTIDINE (OTC) PEPCID AC, FAMOTIDINE (OTC) PEPCID COMPLETE, CALCIUM CARBONATE (OTC)
SINEMET CR, CARBIDOPA

SINEMET, CARBIDOPA
MERIDIAN MEDCL * MERIDIAN MEDICAL TECHNOLOGIES INC DUODOTE, ATROPINE * MERIDIAN MEDICAL TECHNOLOGIES INC SUB KING PHARMACEUTICALS INC ALSUMA, SUMATRIPTAN SUCCINATE MERIDIAN MEDCL TECHN * MERIDIAN MEDICAL TECHNOLOGIES INC ATROPEN, ATROPINE EPIPEN JR., EPINEPHRINE EPIPEN, EPINEPHRINE LIDOPEN, LIDOCAINE HYDROCHLORIDE
MORPHINE SULFATE, MORPHINE SULFATE

PRALIDOXIME CHLORIDE, PRALIDOXIME CHLORIDE
MERRO PHARM * MERRO PHARMACEUTICAL CO LTD IBUPROFEN, IBUPROFEN (OTC) MERZ PHARMS * MERZ PHARMACEUTICALS LLC
ERYGEL, ERYTHROMYCIN

NAFTIN, NAFTIFINE HYDROCHLORIDE
METHAPHARM * METHAPHARM INC
LEVETIRACETAM, LEVETIRACETAM

PROVOCHOLINE, METHACHOLINE CHLORIDE
MICRO LABS LTD * MICRO LABS LTD
MEFENAMIC ACID, MEFENAMIC ACID

SIMVASTATIN, SIMVASTATIN
MIKAH PHARMA * MIKAH PHARMA LLC ISRADIPINE, ISRADIPINE
PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE

TRIMIPRAMINE MALEATE, TRIMIPRAMINE MALEATE
MIKART * MIKART INC ACETAMINOPHEN AND CODEINE PHOSPHATE,

ACETAMINOPHEN

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

B - 85

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** M **

* MIKART INC ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE, ACETAMINOPHEN AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE AMINOCAPROIC ACID, AMINOCAPROIC ACID AMINOCAPROIC, AMINOCAPROIC ACID BENZONATATE, BENZONATATE BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN BUTAPAP, ACETAMINOPHEN CARBINOXAMINE MALEATE, CARBINOXAMINE MALEATE CHLORZOXAZONE, CHLORZOXAZONE DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE ERGOTAMINE TARTRATE AND CAFFEINE, CAFFEINE ESGIC-PLUS, ACETAMINOPHEN ETHOSUXIMIDE, ETHOSUXIMIDE HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN ISONIAZID, ISONIAZID MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE METHAZOLAMIDE, METHAZOLAMIDE OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE PYRAZINAMIDE, PYRAZINAMIDE
TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE
MILLENNIUM PHARMS * MILLENNIUM PHARMACEUTICALS INC VELCADE, BORTEZOMIB MIRROR PHARMS * MIRROR PHARMACEUTICALS LLC BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN CARISOPRODOL AND ASPIRIN, ASPIRIN CARISOPRODOL, CARISOPRODOL CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE, ASPIRIN

PROBENECID AND COLCHICINE, COLCHICINE

MISSION PHARMA * MISSION PHARMACAL CO LITHOSTAT, ACETOHYDROXAMIC ACID TEXACORT, HYDROCORTISONE TINDAMAX, TINIDAZOLE TIOPRONIN, TIOPRONIN

UROCIT-K, POTASSIUM CITRATE

MN PHARMS * MN PHARMACEUTICALS PAMIDRONATE DISODIUM,

PAMIDRONATE DISODIUM

MOLNLYCKE HLTH * MOLNLYCKE HEALTH CARE HIBICLENS, CHLORHEXIDINE GLUCONATE (OTC)

HIBISTAT, CHLORHEXIDINE GLUCONATE (OTC)

MONARCH PHARMS * MONARCH PHARMACEUTICALS INC CORTISPORIN, BACITRACIN ZINC CORTISPORIN, HYDROCORTISONE CORTISPORIN, HYDROCORTISONE ACETATE MENEST, ESTROGENS, ESTERIFIED NEOSPORIN G.U. IRRIGANT, NEOMYCIN SULFATE NEOSPORIN, GRAMICIDIN PEDIOTIC, HYDROCORTISONE SEPTRA DS, SULFAMETHOXAZOLE SEPTRA, SULFAMETHOXAZOLE THALITONE, CHLORTHALIDONE

VIROPTIC, TRIFLURIDINE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B
MONOSOL RX LLC * MONOSOL RX LLC ZUPLENZ, ONDANSETRON

PRODUCT NAME SORTED BY APPLICANT

** M **

MORTON GROVE * MORTON GROVE PHARMACEUTICALS INC

LACTULOSE, LACTULOSE

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE
MORTON GROVE PHARMS * MORTON GROVE PHARMACEUTICALS INC GENERLAC, LACTULOSE MSD CONSUMER * MSD CONSUMER CARE INC ZEGERID OTC, OMEPRAZOLE MSD INTL * MSD INTERNATIONAL GMBH VYTORIN, EZETIMIBE MSP SINGAPORE * MSP SINGAPORE CO LLC ZETIA, EZETIMIBE MURTY PHARMS * MURTY PHARMACEUTICALS INC DIPYRIDAMOLE, DIPYRIDAMOLE MUSTAFA NEVSAT * MUSTAFA NEVSAT ILAC SANAYII AS EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE SODIUM SUCCINATE MUSTAFA NEVZAT * MUSTAFA NEVZAT ILAC SANAYII AS
PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM

VECURONIUM BROMIDE, VECURONIUM BROMIDE
MUTUAL PHARM * MUTUAL PHARMACEUTICAL CO INC ACETAZOLAMIDE, ACETAZOLAMIDE ALBUTEROL SULFATE, ALBUTEROL SULFATE ALLOPURINOL, ALLOPURINOL AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE ATENOLOL AND CHLORTHALIDONE, ATENOLOL ATENOLOL, ATENOLOL BACTRIM DS, SULFAMETHOXAZOLE BACTRIM, SULFAMETHOXAZOLE CARISOPRODOL, CARISOPRODOL CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE ERGOLOID MESYLATES, ERGOLOID MESYLATES FELODIPINE, FELODIPINE HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE, IMIPRAMINE HYDROCHLORIDE LOVASTATIN, LOVASTATIN METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE METOPROLOL TARTRATE, METOPROLOL TARTRATE METRONIDAZOLE, METRONIDAZOLE MINOXIDIL, MINOXIDIL NYSTATIN, NYSTATIN PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE PIROXICAM, PIROXICAM PREDNISONE, PREDNISONE PRIMIDONE, PRIMIDONE
PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE

QUINIDINE GLUCONATE, QUINIDINE GLUCONATE

(OTC)

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** M **

* MUTUAL PHARMACEUTICAL CO INC QUINIDINE SULFATE, QUINIDINE SULFATE SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE SPIRONOLACTONE, SPIRONOLACTONE SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE SULINDAC, SULINDAC TEMAZEPAM, TEMAZEPAM THIORIDAZINE HYDROCHLORIDE, THIORIDAZINE HYDROCHLORIDE TOLMETIN SODIUM, TOLMETIN SODIUM TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE

MUTUAL PHARM CO INC * MUTUAL PHARMACEUTICAL CO INC LEVETIRACETAM, LEVETIRACETAM MUTUAL PHARMA * MUTUAL PHARMACAL CO DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE KETOCONAZOLE, KETOCONAZOLE METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

TRIMETHOBENZAMIDE HYDROCHLORIDE, TRIMETHOBENZAMIDE HYDROCHLORIDE

MYLAN * MYLAN LABORATORIES INC ACYCLOVIR, ACYCLOVIR AMLODIPINE BESYLATE, AMLODIPINE BESYLATE ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE CAPTOPRIL, CAPTOPRIL ETODOLAC, ETODOLAC

TERAZOSIN HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE

* MYLAN PHARMACEUTICALS METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE * MYLAN PHARMACEUTICALS INC ACARBOSE, ACARBOSE ACEBUTOLOL HYDROCHLORIDE, ACEBUTOLOL HYDROCHLORIDE ACYCLOVIR, ACYCLOVIR ALBUTEROL SULFATE, ALBUTEROL SULFATE ALENDRONATE SODIUM, ALENDRONATE SODIUM ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE ALLOPURINOL, ALLOPURINOL ALPRAZOLAM, ALPRAZOLAM AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, AMILORIDE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE AMNESTEEM, ISOTRETINOIN ANASTROZOLE, ANASTROZOLE ATENOLOL AND CHLORTHALIDONE, ATENOLOL ATENOLOL, ATENOLOL ATOMOXETINE HYDROCHLORIDE, ATOMOXETINE HYDROCHLORIDE AVITA, TRETINOIN AZATHIOPRINE, AZATHIOPRINE AZITHROMYCIN, AZITHROMYCIN BACLOFEN, BACLOFEN BALSALAZIDE DISODIUM, BALSALAZIDE DISODIUM BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE BICALUTAMIDE, BICALUTAMIDE BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE, BISOPROLOL FUMARATE BISOPROLOL FUMARATE, BISOPROLOL FUMARATE BROMOCRIPTINE MESYLATE, BROMOCRIPTINE MESYLATE BUDESONIDE, BUDESONIDE BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE
BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE

BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** M **

* MYLAN PHARMACEUTICALS INC CAPTOPRIL AND HYDROCHLOROTHIAZIDE, CAPTOPRIL CARBIDOPA AND LEVODOPA, CARBIDOPA CARVEDILOL, CARVEDILOL CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC) CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC) CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC) CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE CHLOROTHIAZIDE, CHLOROTHIAZIDE CHLORPROPAMIDE, CHLORPROPAMIDE CHLORTHALIDONE, CHLORTHALIDONE CILOSTAZOL, CILOSTAZOL CIMETIDINE, CIMETIDINE CIPROFLOXACIN EXTENDED RELEASE, CIPROFLOXACIN CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE CLARITHROMYCIN, CLARITHROMYCIN CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE CLONAZEPAM, CLONAZEPAM CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE CLORAZEPATE DIPOTASSIUM, CLORAZEPATE DIPOTASSIUM CLORPRES, CHLORTHALIDONE CLOZAPINE, CLOZAPINE CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE CYSTAGON, CYSTEAMINE BITARTRATE DIAZEPAM, DIAZEPAM DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM DICLOFENAC SODIUM, DICLOFENAC SODIUM DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE DIVALPROEX SODIUM, DIVALPROEX SODIUM DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE DOXYCYCLINE, DOXYCYCLINE ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE ENALAPRIL MALEATE, ENALAPRIL MALEATE ESTRADIOL, ESTRADIOL ESTROPIPATE, ESTROPIPATE ETIDRONATE DISODIUM, ETIDRONATE DISODIUM ETOPOSIDE, ETOPOSIDE EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM FAMCICLOVIR, FAMCICLOVIR FAMOTIDINE, FAMOTIDINE FAMOTIDINE, FAMOTIDINE (OTC) FELODIPINE, FELODIPINE FENOFIBRATE, FENOFIBRATE FENOPROFEN CALCIUM, FENOPROFEN CALCIUM FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC) FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC) FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE FINASTERIDE, FINASTERIDE FLUCONAZOLE, FLUCONAZOLE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE FLURBIPROFEN, FLURBIPROFEN FLUTAMIDE, FLUTAMIDE FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM FUROSEMIDE, FUROSEMIDE
GABAPENTIN, GABAPENTIN

GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** M **

* MYLAN PHARMACEUTICALS INC GLIMEPIRIDE, GLIMEPIRIDE GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE GLIPIZIDE, GLIPIZIDE GLYBURIDE (MICRONIZED), GLYBURIDE GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE HALOPERIDOL, HALOPERIDOL HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE INDAPAMIDE, INDAPAMIDE INDOMETHACIN, INDOMETHACIN KETOCONAZOLE, KETOCONAZOLE KETOPROFEN, KETOPROFEN KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE LAMOTRIGINE, LAMOTRIGINE LATANOPROST, LATANOPROST LETROZOLE, LETROZOLE LEVETIRACETAM, LEVETIRACETAM LEVOFLOXACIN, LEVOFLOXACIN LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM LIOTHYRONINE SODIUM, LIOTHYRONINE SODIUM LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LISINOPRIL, LISINOPRIL LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE LORATADINE, LORATADINE (OTC) LORAZEPAM, LORAZEPAM LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM, LOSARTAN POTASSIUM LOVASTATIN, LOVASTATIN LOXAPINE SUCCINATE, LOXAPINE SUCCINATE MAPROTILINE HYDROCHLORIDE, MAPROTILINE HYDROCHLORIDE MECLOFENAMATE SODIUM, MECLOFENAMATE SODIUM MELOXICAM, MELOXICAM MENTAX, BUTENAFINE HYDROCHLORIDE MENTAX-TC, BUTENAFINE HYDROCHLORIDE MERCAPTOPURINE, MERCAPTOPURINE METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE METHIMAZOLE, METHIMAZOLE METHOTREXATE SODIUM, METHOTREXATE SODIUM METHYCLOTHIAZIDE, METHYCLOTHIAZIDE METHYLDOPA AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE METHYLDOPA, METHYLDOPA METOLAZONE, METOLAZONE METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE METOPROLOL TARTRATE, METOPROLOL TARTRATE MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE MIRTAZAPINE, MIRTAZAPINE MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL NADOLOL AND BENDROFLUMETHAZIDE, BENDROFLUMETHIAZIDE NADOLOL, NADOLOL NAPROXEN, NAPROXEN NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE NIFEDIPINE, NIFEDIPINE NISOLDIPINE, NISOLDIPINE NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS), NITROFURANTOIN NITROFURANTOIN, NITROFURANTOIN, MACROCRYSTALLINE NIZATIDINE, NIZATIDINE NORTRIPTYLINE HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE OMEPRAZOLE, OMEPRAZOLE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

ONDANSETRON, ONDANSETRON

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** M **

* MYLAN PHARMACEUTICALS INC OXAPROZIN, OXAPROZIN OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE PACLITAXEL, PACLITAXEL PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE PEG 3350 AND ELECTROLYTES, POLYETHYLENE GLYCOL 3350 PEG-3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE, POLYETHYLENE GLYCOL 3350 PENTOXIFYLLINE, PENTOXIFYLLINE PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE PHENYTEK, PHENYTOIN SODIUM PINDOLOL, PINDOLOL PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE PIROXICAM, PIROXICAM POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC) PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE PRAVASTATIN SODIUM, PRAVASTATIN SODIUM PRAZOSIN HYDROCHLORIDE, PRAZOSIN HYDROCHLORIDE PROBENECID, PROBENECID PROCHLORPERAZINE MALEATE, PROCHLORPERAZINE MALEATE PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC) RISPERIDONE, RISPERIDONE ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE SELEGILINE HYDROCHLORIDE, SELEGILINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE SPIRONOLACTONE, SPIRONOLACTONE STAVUDINE, STAVUDINE SULINDAC, SULINDAC SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE TACROLIMUS, TACROLIMUS TAMOXIFEN CITRATE, TAMOXIFEN CITRATE TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE TEMAZEPAM, TEMAZEPAM TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE, THIORIDAZINE HYDROCHLORIDE THIOTHIXENE, THIOTHIXENE TICLOPIDINE HYDROCHLORIDE, TICLOPIDINE HYDROCHLORIDE TIMOLOL MALEATE, TIMOLOL MALEATE TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE TOLAZAMIDE, TOLAZAMIDE TOLBUTAMIDE, TOLBUTAMIDE TOLMETIN SODIUM, TOLMETIN SODIUM TOPIRAMATE, TOPIRAMATE TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE TRANDOLAPRIL, TRANDOLAPRIL TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE TRIFLUOPERAZINE HYDROCHLORIDE, TRIFLUOPERAZINE HYDROCHLORIDE URSODIOL, URSODIOL VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE WARFARIN SODIUM, WARFARIN SODIUM ZALEPLON, ZALEPLON
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

ZONISAMIDE, ZONISAMIDE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** M **

MYLAN BERTEK * MYLAN BERTEK PHARMACEUTICALS INC AVITA, TRETINOIN

MAXZIDE, HYDROCHLOROTHIAZIDE

MAXZIDE-25, HYDROCHLOROTHIAZIDE
MYLAN INSTITUTIONAL * MYLAN INSTITUTIONAL LLC ALOPRIM, ALLOPURINOL SODIUM DEXRAZOXANE HYDROCHLORIDE, DEXRAZOXANE HYDROCHLORIDE DOLOPHINE HYDROCHLORIDE, METHADONE HYDROCHLORIDE ENLON-PLUS, ATROPINE SULFATE MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE OCTREOTIDE ACETATE (PRESERVATIVE FREE), OCTREOTIDE ACETATE
TRANEXAMIC ACID, TRANEXAMIC ACID

ULTIVA, REMIFENTANIL HYDROCHLORIDE
MYLAN PHARMS INC * MYLAN PHARMACEUTICALS INC EPROSARTAN MESYLATE, EPROSARTAN MESYLATE FLURAZEPAM HYDROCHLORIDE, FLURAZEPAM HYDROCHLORIDE HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LEVETIRACETAM, LEVETIRACETAM
METOPROLOL SUCCINATE, METOPROLOL SUCCINATE

MORPHINE SULFATE, MORPHINE SULFATE
MYLAN TECHNOLOGIES * MYLAN TECHNOLOGIES INC CLONIDINE, CLONIDINE ESTRADIOL, ESTRADIOL FENTANYL-100, FENTANYL FENTANYL-12, FENTANYL FENTANYL-25, FENTANYL FENTANYL-50, FENTANYL
FENTANYL-75, FENTANYL

NITROGLYCERIN, NITROGLYCERIN
NATCO PHARMA * NATCO PHARMA LTD GRANISETRON HYDROCHLORIDE,

GRANISETRON HYDROCHLORIDE

NATCO PHARMA LTD * NATCO PHARMA LIMITED CHLOROQUINE PHOSPHATE, CHLOROQUINE PHOSPHATE * NATCO PHARMA LTD ANASTROZOLE, ANASTROZOLE CHLOROQUINE PHOSPHATE, CHLOROQUINE PHOSPHATE CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE LETROZOLE, LETROZOLE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE
NAUTILUS NEUROSCIENC * NAUTILUS NEUROSCIENCES INC CAMBIA, DICLOFENAC POTASSIUM NAVINTA LLC * NAVINTA LLC FAMOTIDINE, FAMOTIDINE
FOMEPIZOLE, FOMEPIZOLE
NICARDIPINE HYDROCHLORIDE,

NICARDIPINE HYDROCHLORIDE

NEPHRON * NEPHRON CORP

ALBUTEROL SULFATE, ALBUTEROL SULFATE

IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE
* NEPHRON PHARMACEUTICALS CORP ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE,
ALBUTEROL SULFATE, ALBUTEROL SULFATE

ALBUTEROL SULFATE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** N **

NESHER PHARMS * NESHER PHARMACEUTICALS USA LLC BENZONATATE, BENZONATATE BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE DISOPYRAMIDE PHOSPHATE, DISOPYRAMIDE PHOSPHATE DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE METOPROLOL SUCCINATE, METOPROLOL SUCCINATE MICRO-K 10, POTASSIUM CHLORIDE MICRO-K, POTASSIUM CHLORIDE MORPHINE SULFATE, MORPHINE SULFATE NYSTATIN, NYSTATIN ONDANSETRON, ONDANSETRON OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE POTASSIUM CHLORIDE, POTASSIUM CHLORIDE PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE
PREDNISOLONE, PREDNISOLONE

PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE
NEUROGESX * NEUROGESX INC QUTENZA, CAPSAICIN NEW RIVER * NEW RIVER PHARMACEUTICALS INC PROFERDEX, IRON DEXTRAN NEXGEN PHARMA * NEXGEN PHARMA INC BUTALBITAL AND ACETAMINOPHEN, ACETAMINOPHEN BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN
CHENODIOL, CHENODIOL

POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC)
NEXGEN PHARMA INC * NEXGEN PHARMA INC BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE, ACETAMINOPHEN
BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE, ASPIRIN

POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350
NEXUS PHARMS * NEXUS PHARMACEUTICALS INC BENZTROPINE MESYLATE, BENZTROPINE MESYLATE CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE DICLOFENAC SODIUM, DICLOFENAC SODIUM
LEVETIRACETAM, LEVETIRACETAM

LEVOFLOXACIN, LEVOFLOXACIN
NIAGARA PHARMS * NIAGARA PHARMACEUTICALS INC PUR-WASH, PURIFIED WATER

(OTC)

NORTHSTAR HLTHCARE * NORTHSTAR HEALTHCARE HOLDINGS LTD ALLOPURINOL, ALLOPURINOL ATENOLOL, ATENOLOL BACLOFEN, BACLOFEN GEMFIBROZIL, GEMFIBROZIL HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE IBUPROFEN, IBUPROFEN METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** N **

NOSTRUM * NOSTRUM PHARMACEUTICALS INC CARBAMAZEPINE, CARBAMAZEPINE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

THEOPHYLLINE, THEOPHYLLINE
NOSTRUM LABS * NOSTRUM LABORATORIES INC
PIROXICAM, PIROXICAM

SUCRALFATE, SUCRALFATE
NOVADEL * NOVADEL PHARMA INC
NITROMIST, NITROGLYCERIN

ZOLPIMIST, ZOLPIDEM TARTRATE
NOVARTIS * NOVARTIS CONSUMER HEALTH INC EXCEDRIN (MIGRAINE), ACETAMINOPHEN (OTC) HABITROL, NICOTINE (OTC) LAMISIL AT, TERBINAFINE (OTC) LAMISIL AT, TERBINAFINE HYDROCHLORIDE (OTC) LAMISIL, TERBINAFINE HYDROCHLORIDE (OTC) NEXCEDE, KETOPROFEN (OTC) PREVACID 24 HR, LANSOPRAZOLE (OTC) TAVIST ALLERGY/SINUS/HEADACHE, ACETAMINOPHEN THRIVE, NICOTINE POLACRILEX (OTC) TRANSDERM SCOP, SCOPOLAMINE
VAGISTAT-1, TIOCONAZOLE (OTC)

VOLTAREN, DICLOFENAC SODIUM
* NOVARTIS PHARMACEUTICALS CORP AFINITOR, EVEROLIMUS AMTURNIDE, ALISKIREN HEMIFUMARATE ARCAPTA NEOHALER, INDACATEROL MALEATE AREDIA, PAMIDRONATE DISODIUM CATAFLAM, DICLOFENAC POTASSIUM CLOZARIL, CLOZAPINE COARTEM, ARTEMETHER COMBIPATCH, ESTRADIOL DESFERAL, DEFEROXAMINE MESYLATE DIOVAN HCT, HYDROCHLOROTHIAZIDE DIOVAN, VALSARTAN ESTRADERM, ESTRADIOL EXELON, RIVASTIGMINE EXELON, RIVASTIGMINE TARTRATE EXFORGE HCT, AMLODIPINE BESYLATE EXFORGE, AMLODIPINE BESYLATE EXJADE, DEFERASIROX FAMVIR, FAMCICLOVIR FANAPT, ILOPERIDONE FOCALIN XR, DEXMETHYLPHENIDATE HYDROCHLORIDE FOCALIN, DEXMETHYLPHENIDATE HYDROCHLORIDE FORADIL, FORMOTEROL FUMARATE GILENYA, FINGOLIMOD GLEEVEC, IMATINIB MESYLATE HYDERGINE, ERGOLOID MESYLATES LAMISIL, TERBINAFINE HYDROCHLORIDE LAMPRENE, CLOFAZIMINE LESCOL XL, FLUVASTATIN SODIUM LESCOL, FLUVASTATIN SODIUM LOPRESSOR HCT, HYDROCHLOROTHIAZIDE LOPRESSOR, METOPROLOL TARTRATE LOTENSIN HCT, BENAZEPRIL HYDROCHLORIDE
LOTENSIN, BENAZEPRIL HYDROCHLORIDE

LOTREL, AMLODIPINE BESYLATE

(OTC)

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** N **

* NOVARTIS PHARMACEUTICALS CORP METHERGINE, METHYLERGONOVINE MALEATE METOPIRONE, METYRAPONE MIACALCIN, CALCITONIN SALMON MYFORTIC, MYCOPHENOLIC ACID NEORAL, CYCLOSPORINE OCUPRESS, CARTEOLOL HYDROCHLORIDE PARLODEL, BROMOCRIPTINE MESYLATE RECLAST, ZOLEDRONIC ACID REGITINE, PHENTOLAMINE MESYLATE RITALIN LA, METHYLPHENIDATE HYDROCHLORIDE RITALIN, METHYLPHENIDATE HYDROCHLORIDE RITALIN-SR, METHYLPHENIDATE HYDROCHLORIDE SANDIMMUNE, CYCLOSPORINE SANDOSTATIN LAR, OCTREOTIDE ACETATE SANDOSTATIN, OCTREOTIDE ACETATE STARLIX, NATEGLINIDE TASIGNA, NILOTINIB HYDROCHLORIDE MONOHYDRATE TAVIST-1, CLEMASTINE FUMARATE (OTC) TEGRETOL, CARBAMAZEPINE TEGRETOL-XR, CARBAMAZEPINE TEKAMLO, ALISKIREN HEMIFUMARATE TEKTURNA HCT, ALISKIREN HEMIFUMARATE TEKTURNA, ALISKIREN HEMIFUMARATE TRILEPTAL, OXCARBAZEPINE TYZEKA, TELBIVUDINE VALTURNA, ALISKIREN HEMIFUMARATE VASOCIDIN, PREDNISOLONE SODIUM PHOSPHATE VIVELLE, ESTRADIOL VIVELLE-DOT, ESTRADIOL VOLTAREN, DICLOFENAC SODIUM VOLTAREN-XR, DICLOFENAC SODIUM ZOMETA, ZOLEDRONIC ACID

ZORTRESS, EVEROLIMUS

NOVARTIS PHARMS * NOVARTIS PHARMACEUTICALS CORP FEMARA, LETROZOLE

TOBI, TOBRAMYCIN

NOVAST LABS LTD * NOVAST LABORATORIES LTD DASETTA 1/35, ETHINYL ESTRADIOL DASETTA 7/7/7, ETHINYL ESTRADIOL
LEVONEST, ETHINYL ESTRADIOL

PHILITH, ETHINYL ESTRADIOL
NOVEL LABS INC * NOVEL LABORATORIES INC HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE, HOMATROPINE METHYLBROMIDE METHYLERGONOVINE MALEATE, METHYLERGONOVINE MALEATE MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE, SODIUM PHOSPHATE, DIBASIC, ANHYDROUS PEG 3350 AND ELECTROLYTES, POLYETHYLENE GLYCOL 3350 PEG-3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE, POLYETHYLENE GLYCOL 3350 PHENELZINE SULFATE, PHENELZINE SULFATE POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC) SULFAMETHOPRIM, SULFAMETHOXAZOLE SULFAMETHOPRIM-DS, SULFAMETHOXAZOLE TEMAZEPAM, TEMAZEPAM TRIMETHOPRIM, TRIMETHOPRIM NOVEN * NOVEN PHARMACEUTICALS INC FENTANYL-100, FENTANYL

FENTANYL-25, FENTANYL

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APPENDIX B
* NOVEN PHARMACEUTICALS INC
FENTANYL-50, FENTANYL

FENTANYL-75, FENTANYL

PRODUCT NAME SORTED BY APPLICANT

** N **

NOVEN PHARMS INC * NOVEN PHARMACEUTICALS INC DAYTRANA, METHYLPHENIDATE NOVEN THERAP * NOVEN THERAPEUTICS LLC
LITHOBID, LITHIUM CARBONATE

PEXEVA, PAROXETINE MESYLATE
NOVEX * NOVEX PHARMA ALBUTEROL SULFATE, ALBUTEROL SULFATE BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE CARTEOLOL HYDROCHLORIDE, CARTEOLOL HYDROCHLORIDE CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE CLEMASTINE FUMARATE, CLEMASTINE FUMARATE CROMOLYN SODIUM, CROMOLYN SODIUM CYCLOSPORINE, CYCLOSPORINE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE LACTULOSE, LACTULOSE LEVOBUNOLOL HYDROCHLORIDE, LEVOBUNOLOL HYDROCHLORIDE METAPROTERENOL SULFATE, METAPROTERENOL SULFATE MINOXIDIL (FOR MEN), MINOXIDIL (OTC) MINOXIDIL (FOR WOMEN), MINOXIDIL (OTC) MINOXIDIL EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC) OFLOXACIN, OFLOXACIN
OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

TOBRAMYCIN, TOBRAMYCIN
NOVO NORDISK * NOVO NORDISK PHARMACEUTICALS INC GLUCAGEN, GLUCAGON HYDROCHLORIDE RECOMBINANT NOVO NORDISK INC * NOVO NORDISK INC ACTIVELLA, ESTRADIOL LEVEMIR, INSULIN DETEMIR RECOMBINANT NORDITROPIN FLEXPRO, SOMATROPIN RECOMBINANT NORDITROPIN NORDIFLEX, SOMATROPIN RECOMBINANT NORDITROPIN, SOMATROPIN RECOMBINANT NOVOLIN 70/30, INSULIN RECOMBINANT HUMAN (OTC) NOVOLIN N, INSULIN SUSP ISOPHANE RECOMBINANT HUMAN (OTC) NOVOLIN R, INSULIN RECOMBINANT HUMAN (OTC) NOVOLOG MIX 70/30, INSULIN ASPART PROTAMINE RECOMBINANT NOVOLOG, INSULIN ASPART RECOMBINANT PRANDIMET, METFORMIN HYDROCHLORIDE PRANDIN, REPAGLINIDE
VAGIFEM, ESTRADIOL

VICTOZA, LIRAGLUTIDE RECOMBINANT
NOVOCOL * NOVOCOL PHARMACEUTICAL INC
ISOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN, LEVONORDEFRIN

ISOCAINE HYDROCHLORIDE, MEPIVACAINE HYDROCHLORIDE
NOVOCOL INC * NOVOCOL INC LIDOCAINE,

LIDOCAINE

NU PHARM * NU PHARM INC DIVALPROEX SODIUM,

DIVALPROEX SODIUM

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** N **

NYCOMED US * NYCOMED US INC ADAPALENE, ADAPALENE ALVESCO, CICLESONIDE CALCIPOTRIENE, CALCIPOTRIENE CARMOL HC, HYDROCORTISONE ACETATE CICLOPIROX, CICLOPIROX CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE CLOTRIMAZOLE, CLOTRIMAZOLE DESOXIMETASONE, DESOXIMETASONE IMIQUIMOD, IMIQUIMOD LIDOCAINE AND PRILOCAINE, LIDOCAINE MOMETASONE FUROATE, MOMETASONE FUROATE OMNARIS, CICLESONIDE TEMOVATE, CLOBETASOL PROPIONATE TERCONAZOLE, TERCONAZOLE TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE
TYZINE, TETRAHYDROZOLINE HYDROCHLORIDE

ZONALON, DOXEPIN HYDROCHLORIDE
OAK PHARMS * OAK PHARMACEUTICALS INC
EMLA, LIDOCAINE

XYLOCAINE, LIDOCAINE HYDROCHLORIDE
ODYSSEY PHARMS * ODYSSEY PHARMACEUTICALS INC ANTABUSE, DISULFIRAM NYSTATIN, NYSTATIN SURMONTIL, TRIMIPRAMINE MALEATE
URECHOLINE, BETHANECHOL CHLORIDE

VIVACTIL, PROTRIPTYLINE HYDROCHLORIDE
OHM * OHM CORP IBUPROFEN,

IBUPROFEN

(OTC)

OHM LABS * OHM LABORATORIES INC ACETAMINOPHEN, ACETAMINOPHEN (OTC) IBUPROFEN, IBUPROFEN IBUPROHM COLD AND SINUS, IBUPROFEN (OTC)
IBUPROHM, IBUPROFEN (OTC)
LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE OLTA PHARMS * OLTA PHARMACEUTICALS CORP LINDANE, LINDANE OMAN PHARM PRODUCTS * OMAN PHARMACEUTICAL PRODUCTS CO LLC NEOMYCIN SULFATE, NEOMYCIN SULFATE

(OTC)

ONCO THERAPIES LTD * ONCO THERAPIES LTD CARBOPLATIN, CARBOPLATIN CLADRIBINE, CLADRIBINE CYTARABINE, CYTARABINE DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE
GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE

PACLITAXEL, PACLITAXEL
ONY * ONY INC INFASURF PRESERVATIVE FREE,

CALFACTANT

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APPENDIX B
OPTIMER PHARMS * OPTIMER PHARMACEUTICALS INC DIFICID, FIDAXOMICIN

PRODUCT NAME SORTED BY APPLICANT

** O **

ORAPHARMA * ORAPHARMA INC ARESTIN, MINOCYCLINE HYDROCHLORIDE ORCHID HLTHCARE * ORCHID HEALTHCARE AMLODIPINE BESYLATE, AMLODIPINE BESYLATE CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE CEFDINIR, CEFDINIR CEFPODOXIME PROXETIL, CEFPODOXIME PROXETIL CEFPROZIL, CEFPROZIL CEFUROXIME AXETIL, CEFUROXIME AXETIL CEPHALEXIN, CEPHALEXIN CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC) DESLORATADINE, DESLORATADINE DIVALPROEX SODIUM, DIVALPROEX SODIUM GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE LEVETIRACETAM, LEVETIRACETAM SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
* ORCHID HEALTHCARE DIV ORCHID CHEMICALS AND PHARMACEUTICALS LTD ZALEPLON, ZALEPLON ORGANON USA INC * ORGANON USA INC CYCLESSA, DESOGESTREL DESOGEN, DESOGESTREL FOLLISTIM AQ, FOLLITROPIN ALFA/BETA GANIRELIX ACETATE INJECTION, GANIRELIX ACETATE IMPLANON, ETONOGESTREL NEXPLANON, ETONOGESTREL NUVARING, ETHINYL ESTRADIOL PREGNYL, GONADOTROPIN, CHORIONIC REMERON SOLTAB, MIRTAZAPINE
REMERON, MIRTAZAPINE

SAPHRIS, ASENAPINE MALEATE
ORION * ORION CORP COMTAN, ENTACAPONE STALEVO 100, CARBIDOPA STALEVO 125, CARBIDOPA STALEVO 150, CARBIDOPA STALEVO 200, CARBIDOPA
STALEVO 50, CARBIDOPA

STALEVO 75, CARBIDOPA
ORIT LABS LLC * ORIT LABORATORIES LLC BENZONATATE, BENZONATATE
CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE

ERGOCALCIFEROL, ERGOCALCIFEROL
ORPHAN EUROPE * ORPHAN EUROPE CARBAGLU, CARGLUMIC ACID ORTHO BIOTECH * ORTHO BIOTECH PRODUCTS LP DOXIL, DOXORUBICIN HYDROCHLORIDE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** O **

ORTHO JANSSEN * ORTHO DERMATOLOGICS DIV JANSSEN PHARMACEUTICALS INC ERTACZO, SERTACONAZOLE NITRATE
RENOVA, TRETINOIN

RETIN-A, TRETINOIN
ORTHO MCNEIL JANSSEN * ORTHO MCNEIL JANSSEN PHARMACEUTICALS INC NIZORAL, KETOCONAZOLE ORTHONEUTROGENA * ORTHONEUTROGENA GRIFULVIN V, GRISEOFULVIN, MICROCRYSTALLINE OSI PHARMS * OSI PHARMACEUTICALS INC TARCEVA, ERLOTINIB HYDROCHLORIDE OSMOTICA PHARM * OSMOTICA PHARMACEUTICAL CORP NIFEDIPINE, NIFEDIPINE
OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
OTSUKA * OTSUKA PHARMACEUTICAL CO LTD
ABILIFY, ARIPIPRAZOLE

PLETAL, CILOSTAZOL
* OTSUKA PHARMACEUTICAL DEVELOPMENT AND COMMERCIALIZATION INC ABILIFY, ARIPIPRAZOLE OTSUKA AMERICA * OTSUKA AMERICA PHARMACEUTICALS INC BREATHTEK UBT FOR H-PYLORI, UREA C-13 OTSUKA AMERICA PHARM * OTSUKA AMERICA PHARMACEUTICAL INC SAMSCA, TOLVAPTAN OTSUKA PHARM * OTSUKA PHARMACEUTICAL CO LTD BUSULFEX, BUSULFAN OUTLOOK PHARMS * OUTLOOK PHARMACEUTICALS INC DEXTROAMPHETAMINE SULFATE, PACIFIC PHARMA * PACIFIC PHARMA TIMOLOL MALEATE, * PACIFIC PHARMA INC TIMOLOL MALEATE,

DEXTROAMPHETAMINE SULFATE

TIMOLOL MALEATE TIMOLOL MALEATE

PACIRA PHARMS INC * PACIRA PHARMACEUTICALS INC

DEPOCYT, CYTARABINE

EXPAREL, BUPIVACAINE
PACK PHARMS LLC * PACK PHARMACEUTICALS LLC CROMOLYN SODIUM, CROMOLYN SODIUM PADDOCK * PADDOCK LABORATORIES INC BENZPHETAMINE HYDROCHLORIDE,

BENZPHETAMINE HYDROCHLORIDE

PADDOCK LABS * PADDOCK LABORATORIES INC CLINDAMYCIN PALMITATE HYDROCHLORIDE, PADDOCK LLC * PADDOCK LABORATORIES LLC AMMONIUM LACTATE, AMMONIUM LACTATE

CLINDAMYCIN PALMITATE HYDROCHLORIDE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** P **

* PADDOCK LABORATORIES LLC BROMOCRIPTINE MESYLATE, BROMOCRIPTINE MESYLATE CAFFEINE CITRATE, CAFFEINE CITRATE CALCIUM ACETATE, CALCIUM ACETATE CICLOPIROX, CICLOPIROX CLENZ-LYTE, POLYETHYLENE GLYCOL 3350 CLINDA-DERM, CLINDAMYCIN PHOSPHATE CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE CLOTRIMAZOLE, CLOTRIMAZOLE COLISTIMETHATE SODIUM, COLISTIMETHATE SODIUM COLOCORT, HYDROCORTISONE COMPRO, PROCHLORPERAZINE DIHYDROERGOTAMINE MESYLATE, DIHYDROERGOTAMINE MESYLATE ERYTHRA-DERM, ERYTHROMYCIN FLAVOXATE HYDROCHLORIDE, FLAVOXATE HYDROCHLORIDE INDOMETHACIN, INDOMETHACIN KIONEX, SODIUM POLYSTYRENE SULFONATE LATANOPROST, LATANOPROST LAX-LYTE WITH FLAVOR PACKS, POLYETHYLENE GLYCOL 3350 LORAZEPAM, LORAZEPAM MIDAMOR, AMILORIDE HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE MOEXIPRIL HYDROCHLORIDE, MOEXIPRIL HYDROCHLORIDE NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE NYSTOP, NYSTATIN PODOFILOX, PODOFILOX POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES, POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC) POTASSIUM CHLORIDE, POTASSIUM CHLORIDE PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE SODIUM POLYSTYRENE SULFONATE, SODIUM POLYSTYRENE SULFONATE TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE
TESTOSTERONE ENANTHATE, TESTOSTERONE ENANTHATE

TROSPIUM CHLORIDE, TROSPIUM CHLORIDE
PALADIN LABS * PALADIN LABS USA INC ANTIZOL, FOMEPIZOLE PAR PHARM * PAR PHARMACEUTICAL NABUMETONE, NABUMETONE OMEPRAZOLE AND SODIUM BICARBONATE, OMEPRAZOLE PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE


TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
* PAR PHARMACEUTICAL INC ALPRAZOLAM, ALPRAZOLAM AMILORIDE HYDROCHLORIDE, AMILORIDE HYDROCHLORIDE AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE CABERGOLINE, CABERGOLINE CALCITONIN-SALMON, CALCITONIN SALMON CAPOTEN, CAPTOPRIL CHOLESTYRAMINE LIGHT, CHOLESTYRAMINE CHOLESTYRAMINE, CHOLESTYRAMINE CLOMIPHENE CITRATE, CLOMIPHENE CITRATE CLONAZEPAM, CLONAZEPAM CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE DEXAMETHASONE, DEXAMETHASONE DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE
DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE

DOXYCYCLINE, DOXYCYCLINE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** P **

* PAR PHARMACEUTICAL INC ESTAZOLAM, ESTAZOLAM FLUTAMIDE, FLUTAMIDE GLYCOPYRROLATE, GLYCOPYRROLATE HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE HYDRA-ZIDE, HYDRALAZINE HYDROCHLORIDE HYDROXYUREA, HYDROXYUREA IBUPROFEN, IBUPROFEN (OTC) IMIPRAMINE HYDROCHLORIDE, IMIPRAMINE HYDROCHLORIDE ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE LEVETIRACETAM, LEVETIRACETAM MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE MEGACE ES, MEGESTROL ACETATE MEGESTROL ACETATE, MEGESTROL ACETATE METAPROTERENOL SULFATE, METAPROTERENOL SULFATE METRONIDAZOLE, METRONIDAZOLE MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE MINOXIDIL, MINOXIDIL NASCOBAL, CYANOCOBALAMIN NATEGLINIDE, NATEGLINIDE NYSTATIN, NYSTATIN OLANZAPINE, OLANZAPINE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE ONDANSETRON, ONDANSETRON OXANDROLONE, OXANDROLONE RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE RISPERIDONE, RISPERIDONE SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE TORSEMIDE, TORSEMIDE TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN TRANYLCYPROMINE SULFATE, TRANYLCYPROMINE SULFATE
VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE
PARAPRO PHARMS * PARAPRO PHARMACEUTICALS LLC NATROBA, SPINOSAD PARKE DAVIS * PARKE DAVIS DIV WARNER LAMBERT CO CELONTIN, METHSUXIMIDE DILANTIN, PHENYTOIN SODIUM DILANTIN-125, PHENYTOIN NARDIL, PHENELZINE SULFATE NEURONTIN, GABAPENTIN


ZARONTIN, ETHOSUXIMIDE
* PARKE DAVIS PHARMACEUTICAL RESEARCH DIV WARNER LAMBERT CO ZARONTIN, ETHOSUXIMIDE PBS * PBS REGULATORY CONSULTING SERVICES INC LEUKERAN, CHLORAMBUCIL PEDIATRX * PEDIATRX INC GRANISETRON HYDROCHLORIDE,

GRANISETRON HYDROCHLORIDE

PEDINOL * PEDINOL PHARMACAL INC

GRIS-PEG, GRISEOFULVIN, ULTRAMICROCRYSTALLINE
NALFON, FENOPROFEN CALCIUM

PERNIX THERAP * PERNIX THERAPEUTICS LLC CEDAX, CEFTIBUTEN DIHYDRATE PERRIGO * L PERRIGO CO ACETAMINOPHEN,

ACETAMINOPHEN

(OTC)

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** P **

* L PERRIGO CO ACETAMINOPHEN, ASPIRIN AND CAFFEINE, ACETAMINOPHEN (OTC) CHILDREN'S IBUPROFEN, IBUPROFEN (OTC) CROMOLYN SODIUM, CROMOLYN SODIUM (OTC) DOXYLAMINE SUCCINATE, DOXYLAMINE SUCCINATE (OTC) FAMOTIDINE, FAMOTIDINE (OTC) IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE, IBUPROFEN (OTC) IBUPROFEN, IBUPROFEN (OTC) LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE, LOPERAMIDE HYDROCHLORIDE (OTC) LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC) LORATADINE, LORATADINE (OTC) MICONAZOLE 3 COMBINATION PACK, MICONAZOLE NITRATE (OTC) MICONAZOLE NITRATE, MICONAZOLE NITRATE (OTC) MINOXIDIL EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC) NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE, NAPROXEN SODIUM (OTC) NAPROXEN SODIUM, NAPROXEN SODIUM (OTC) RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC) TAB-PROFEN, IBUPROFEN (OTC)

TIOCONAZOLE, TIOCONAZOLE (OTC)

* PERRIGO CO CICLOPIROX, CICLOPIROX CIMETIDINE, CIMETIDINE (OTC) CLEMASTINE FUMARATE, CLEMASTINE FUMARATE (OTC) CLINDETS, CLINDAMYCIN PHOSPHATE CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE ERYTHROMYCIN, ERYTHROMYCIN FAMOTIDINE, FAMOTIDINE FAMOTIDINE, FAMOTIDINE (OTC) HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE IBUPROFEN, IBUPROFEN (OTC) JUNIOR STRENGTH IBUPROFEN, IBUPROFEN (OTC) LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC) MICONAZOLE NITRATE COMBINATION PACK, MICONAZOLE NITRATE (OTC) MINOXIDIL (FOR MEN), MINOXIDIL (OTC) MINOXIDIL (FOR WOMEN), MINOXIDIL (OTC) MOMETASONE FUROATE, MOMETASONE FUROATE NICOTINE POLACRILEX, NICOTINE POLACRILEX (OTC) PSEUDOEPHEDRINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (OTC) STIE-CORT, HYDROCORTISONE PERRIGO CO TENNESSEE * PERRIGO CO TENNESSEE INC
GRISEOFULVIN, GRISEOFULVIN, MICROCRYSTALLINE

SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM
PERRIGO ISRAEL * PERRIGO ISRAEL PHARMACEUTICALS LTD CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE IMIQUIMOD, IMIQUIMOD KETOCONAZOLE, KETOCONAZOLE
MESALAMINE, MESALAMINE

MINOXIDIL, MINOXIDIL (OTC)
PERRIGO NEW YORK * PERRIGO NEW YORK INC ACETAMINOPHEN, ACETAMINOPHEN (OTC) AMMONIUM LACTATE, AMMONIUM LACTATE BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE CENTANY, MUPIROCIN CICLOPIROX, CICLOPIROX CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE DESONIDE, DESONIDE DESOXIMETASONE, DESOXIMETASONE
ECONAZOLE NITRATE, ECONAZOLE NITRATE

ERYTHROMYCIN, ERYTHROMYCIN

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

B - 102

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** P **

* PERRIGO NEW YORK INC FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE GENTAMICIN SULFATE, GENTAMICIN SULFATE HYDROCORTISONE VALERATE, HYDROCORTISONE VALERATE HYDROCORTISONE, HYDROCORTISONE KETOCONAZOLE, KETOCONAZOLE MINOXIDIL EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC) MOMETASONE FUROATE, MOMETASONE FUROATE MUPIROCIN, MUPIROCIN NYSTATIN, NYSTATIN PERMETHRIN, PERMETHRIN PERMETHRIN, PERMETHRIN (OTC) PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE SELENIUM SULFIDE, SELENIUM SULFIDE TERCONAZOLE, TERCONAZOLE

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

PERRIGO R AND D * PERRIGO R AND D CO CALCIUM CARBONATE, FAMOTIDINE AND MAGNESIUM HYDROXIDE, CALCIUM CARBONATE (OTC) CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) DESLORATADINE, DESLORATADINE GUAIFENESIN, GUAIFENESIN (OTC) IBUPROFEN AND DIPHENHYDRAMINE CITRATE, DIPHENHYDRAMINE CITRATE (OTC) IBUPROFEN, IBUPROFEN IBUPROFEN, IBUPROFEN (OTC) LEVONORGESTREL, LEVONORGESTREL LEVONORGESTREL, LEVONORGESTREL (OTC) MICONAZOLE NITRATE, MICONAZOLE NITRATE (OTC) NAPROXEN, NAPROXEN
NICOTINE POLACRILEX, NICOTINE POLACRILEX (OTC)

POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC)
* PERRIGO R AND D COMPANY LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC)
NICOTINE POLACRILEX, NICOTINE POLACRILEX (OTC)

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC)
PERRIGO UK FINCO * PERRIGO UK FINCO LTD PARTNERSHIP CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE PETNET * PETNET SOLUTIONS INC FLUDEOXYGLUCOSE F18,

FLUDEOXYGLUCOSE F-18

PFIZER * PFIZER CENTRAL RESEARCH

DIFLUCAN, FLUCONAZOLE
ZITHROMAX, AZITHROMYCIN

* PFIZER CHEMICALS DIV PFIZER INC DIFLUCAN, FLUCONAZOLE

ZITHROMAX, AZITHROMYCIN

* PFIZER INC ANTIVERT, MECLIZINE HYDROCHLORIDE ARGATROBAN, ARGATROBAN CADUET, AMLODIPINE BESYLATE CARDURA XL, DOXAZOSIN MESYLATE CHILDREN'S ZYRTEC ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CHILDREN'S ZYRTEC HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER, FLUCONAZOLE DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE

DIFLUCAN IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

B - 103

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** P **

* PFIZER INC FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE FAMOTIDINE, FAMOTIDINE FLAGYL I.V. RTU IN PLASTIC CONTAINER, METRONIDAZOLE FLUMAZENIL, FLUMAZENIL FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM GEODON, ZIPRASIDONE HYDROCHLORIDE GEODON, ZIPRASIDONE MESYLATE GLUCOTROL XL, GLIPIZIDE GLUCOTROL, GLIPIZIDE HALOPERIDOL, HALOPERIDOL LACTATE HEPARIN SODIUM PRESERVATIVE FREE, HEPARIN SODIUM HEPARIN SODIUM, HEPARIN SODIUM ISOPTIN SR, VERAPAMIL HYDROCHLORIDE KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE LIPITOR, ATORVASTATIN CALCIUM NAVANE, THIOTHIXENE NORVASC, AMLODIPINE BESYLATE ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM PROCARDIA, NIFEDIPINE REVATIO, SILDENAFIL CITRATE RIFAMPIN, RIFAMPIN TOVIAZ, FESOTERODINE FUMARATE UNASYN, AMPICILLIN SODIUM VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE VECURONIUM BROMIDE, VECURONIUM BROMIDE VFEND, VORICONAZOLE XALKORI, CRIZOTINIB

ZITHROMAX, AZITHROMYCIN

* PFIZER LABORATORIES DIV PFIZER INC CARDURA, DOXAZOSIN MESYLATE DIABINESE, CHLORPROPAMIDE FELDENE, PIROXICAM MINIPRESS, PRAZOSIN HYDROCHLORIDE PERMAPEN, PENICILLIN G BENZATHINE PFIZERPEN, PENICILLIN G POTASSIUM PROCARDIA XL, NIFEDIPINE TERRAMYCIN W/ POLYMYXIN B SULFATE, OXYTETRACYCLINE HYDROCHLORIDE UNASYN, AMPICILLIN SODIUM VIBRAMYCIN, DOXYCYCLINE VIBRAMYCIN, DOXYCYCLINE CALCIUM VIBRAMYCIN, DOXYCYCLINE HYCLATE


VISTARIL, HYDROXYZINE PAMOATE
* PFIZER PHARMACEUTICALS INC ZOLOFT, SERTRALINE HYDROCHLORIDE * PFIZER PHARMACEUTICALS PRODUCTION CORP LTD TIKOSYN, DOFETILIDE PFIZER CONS HLTHCARE * PFIZER CONSUMER HEALTHCARE ADVIL ALLERGY AND CONGESTION RELIEF, CHLORPHENIRAMINE MALEATE ADVIL PM, DIPHENHYDRAMINE CITRATE (OTC)
PFIZER GLOBAL * PFIZER GLOBAL RESEARCH DEVELOPMENT ZMAX, AZITHROMYCIN PFIZER INC * PFIZER INC CAMPTOSAR, IRINOTECAN HYDROCHLORIDE CHANTIX, VARENICLINE TARTRATE ELLENCE, EPIRUBICIN HYDROCHLORIDE
GEODON, ZIPRASIDONE HYDROCHLORIDE

NICOTROL, NICOTINE

(OTC)

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

B - 104

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** P **

PFIZER IRELAND * PFIZER IRELAND PHARMACEUTICALS

RELPAX, ELETRIPTAN HYDROBROMIDE

VIAGRA, SILDENAFIL CITRATE
PFIZER PHARMS * PFIZER PHARMACEUTICALS LTD ACCUPRIL, QUINAPRIL HYDROCHLORIDE ACCURETIC, HYDROCHLOROTHIAZIDE DILANTIN, PHENYTOIN LOPID, GEMFIBROZIL
NEURONTIN, GABAPENTIN

NITROSTAT, NITROGLYCERIN
PHARM ASSOC * PHARMACEUTICAL ASSOC INC DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN LORAZEPAM, LORAZEPAM
NORTRIPTYLINE HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE

PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE
* PHARMACEUTICAL ASSOC INC DIV BEACH PRODUCTS ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE ETHOSUXIMIDE, ETHOSUXIMIDE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE HALOPERIDOL, HALOPERIDOL LACTATE HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN LACTULOSE, LACTULOSE METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE PREDNISOLONE, PREDNISOLONE PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE

VALPROIC ACID, VALPROIC ACID
PHARMA SERVE NY * PHARMA SERVE INC SUB TORIGIAN LABORATORIES AMINOPHYLLINE, AMINOPHYLLINE PHARMACHEMIE * PHARMACHEMIE BV CARBOPLATIN, CARBOPLATIN CISPLATIN, CISPLATIN DOXORUBICIN HYDROCHLORIDE,
ETOPOSIDE, ETOPOSIDE

DOXORUBICIN HYDROCHLORIDE

PHARMACHEMIE BV * PHARMACHEMIE BV BLEOMYCIN SULFATE, BLEOMYCIN SULFATE

CARBOPLATIN, CARBOPLATIN
METHOTREXATE SODIUM PRESERVATIVE FREE, PHARMACIA AND UPJOHN * PHARMACIA AND UPJOHN XANAX XR, ALPRAZOLAM * PHARMACIA AND UPJOHN CO ANSAID, FLURBIPROFEN AROMASIN, EXEMESTANE AZULFIDINE EN-TABS, SULFASALAZINE AZULFIDINE, SULFASALAZINE
BACITRACIN, BACITRACIN

CAVERJECT IMPULSE, ALPROSTADIL

METHOTREXATE SODIUM

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

B - 105

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** P **

* PHARMACIA AND UPJOHN CO CAVERJECT, ALPROSTADIL CLEOCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER, CLEOCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE CLEOCIN T, CLINDAMYCIN PHOSPHATE CLEOCIN, CLINDAMYCIN PALMITATE HYDROCHLORIDE CLEOCIN, CLINDAMYCIN PHOSPHATE COLESTID, COLESTIPOL HYDROCHLORIDE CORTEF, HYDROCORTISONE CORVERT, IBUTILIDE FUMARATE CYKLOKAPRON, TRANEXAMIC ACID DEPO-ESTRADIOL, ESTRADIOL CYPIONATE DEPO-MEDROL, METHYLPREDNISOLONE ACETATE DEPO-PROVERA, MEDROXYPROGESTERONE ACETATE DEPO-TESTOSTERONE, TESTOSTERONE CYPIONATE DETROL LA, TOLTERODINE TARTRATE DETROL, TOLTERODINE TARTRATE DIDREX, BENZPHETAMINE HYDROCHLORIDE EMCYT, ESTRAMUSTINE PHOSPHATE SODIUM ESTRING, ESTRADIOL FLAVORED COLESTID, COLESTIPOL HYDROCHLORIDE GENOTROPIN PRESERVATIVE FREE, SOMATROPIN RECOMBINANT GENOTROPIN, SOMATROPIN RECOMBINANT GLYNASE, GLYBURIDE GLYSET, MIGLITOL HALCION, TRIAZOLAM HEMABATE, CARBOPROST TROMETHAMINE IDAMYCIN PFS, IDARUBICIN HYDROCHLORIDE LINCOCIN, LINCOMYCIN HYDROCHLORIDE MEDROL, METHYLPREDNISOLONE MYCOBUTIN, RIFABUTIN NICOTROL, NICOTINE OGEN .625, ESTROPIPATE OGEN 1.25, ESTROPIPATE OGEN 2.5, ESTROPIPATE OGEN 5, ESTROPIPATE PREPIDIL, DINOPROSTONE PROSTIN E2, DINOPROSTONE PROSTIN VR PEDIATRIC, ALPROSTADIL PROVERA, MEDROXYPROGESTERONE ACETATE R-GENE 10, ARGININE HYDROCHLORIDE SOLU-CORTEF, HYDROCORTISONE SODIUM SUCCINATE SOLU-MEDROL, METHYLPREDNISOLONE SODIUM SUCCINATE SOMAVERT, PEGVISOMANT XALATAN, LATANOPROST XANAX, ALPRAZOLAM
ZINECARD, DEXRAZOXANE HYDROCHLORIDE

ZYVOX, LINEZOLID
* PHARMACIA AND UPJOHN SUB PFIZER INC DEPO-SUBQ PROVERA 104, MEDROXYPROGESTERONE ACETATE

CLINDAMYCIN PHOSPHATE

PHARMAFORCE * PHARMAFORCE INC CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE EPINASTINE HYDROCHLORIDE, EPINASTINE HYDROCHLORIDE NANDROLONE DECANOATE, NANDROLONE DECANOATE
NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE

TRANEXAMIC ACID, TRANEXAMIC ACID
PHARMALUCENCE * PHARMALUCENCE INC AN-DTPA, TECHNETIUM TC-99M PENTETATE KIT
AN-SULFUR COLLOID, TECHNETIUM TC-99M SULFUR COLLOID KIT

CIS-MDP, TECHNETIUM TC-99M MEDRONATE KIT

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

B - 106

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** P **

* PHARMALUCENCE INC CIS-PYRO, TECHNETIUM TC-99M PYROPHOSPHATE KIT HEPATOLITE, TECHNETIUM TC-99M DISOFENIN KIT PULMOLITE, TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT TECHNETIUM TC 99M SESTAMIBI, TECHNETIUM TC-99M SESTAMIBI KIT

TECHNETIUM TC-99M MEBROFENIN, TECHNETIUM TC-99M MEBROFENIN KIT

PHARMAX * PHARMAX GROUP INC BETHANECHOL CHLORIDE, PHARMAXIS * PHARMAXIS INC ARIDOL KIT,

BETHANECHOL CHLORIDE

MANNITOL

PIERRE FABRE * PIERRE FABRE MEDICAMENT NAVELBINE, VINORELBINE TARTRATE PIERREL * PIERREL S.P.A. ARTICAINE HYDROCHLORIDE WITH EPINEPHRINE, PINNACLE BIOLGS * PINNACLE BIOLOGICS INC PHOTOFRIN, PORFIMER SODIUM PIRAMAL CRITICAL * PIRAMAL CRITICAL CARE INC ENFLURANE, ENFLURANE
ISOFLURANE, ISOFLURANE

SOJOURN, SEVOFLURANE
PLANTEX * PLANTEX USA INC DIV IKAPHARM INC SULFAMETHOXAZOLE AND TRIMETHOPRIM SINGLE STRENGTH,

ARTICAINE HYDROCHLORIDE

SULFAMETHOXAZOLE

PLIVA * PLIVA INC AZITHROMYCIN, AZITHROMYCIN BENZTROPINE MESYLATE, BENZTROPINE MESYLATE CARBOPLATIN, CARBOPLATIN CHLORPROPAMIDE, CHLORPROPAMIDE CHLORTHALIDONE, CHLORTHALIDONE CIMETIDINE, CIMETIDINE CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE CYCLOSPORINE, CYCLOSPORINE DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE FLUCONAZOLE, FLUCONAZOLE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE KETOCONAZOLE, KETOCONAZOLE KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE METRONIDAZOLE, METRONIDAZOLE NAPROXEN, NAPROXEN OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE PENTOXIFYLLINE, PENTOXIFYLLINE PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE THEOPHYLLINE, THEOPHYLLINE TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

WARFARIN SODIUM, WARFARIN SODIUM

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

B - 107

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** P **

PLIVA HRVATSKA DOO * PLIVA HRVATSKA DOO ADAPALENE, ADAPALENE AZITHROMYCIN, AZITHROMYCIN CARVEDILOL, CARVEDILOL CILOSTAZOL, CILOSTAZOL DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

RISPERIDONE, RISPERIDONE
PLIVA LACHEMA * PLIVA LACHEMA AS CARBOPLATIN, CARBOPLATIN
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM
PLIVA PHARM IND * PLIVA PHARMACEUTICAL INDUSTRY INC TORSEMIDE, TORSEMIDE POHL BOSKAMP * POHL BOSKAMP NITROLINGUAL PUMPSPRAY,

NITROGLYCERIN

POLYMEDICA * POLYMEDICA INDUSTRIES INC

ANESTACON, LIDOCAINE HYDROCHLORIDE

NEOPAP, ACETAMINOPHEN (OTC)
PRASCO * PRASCO LLC DBA PRASCO LABORATORIES ECONAZOLE NITRATE, ECONAZOLE NITRATE PRECISION DERMAT * PRECISION DERMATOLOGY INC PODOFILOX, PODOFILOX PRECISION DOSE * PRECISION DOSE INC RISPERIDONE, RISPERIDONE PRINSTON INC * PRINSTON PHARMACEUTICAL INC BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE CAPTOPRIL, CAPTOPRIL LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LISINOPRIL, LISINOPRIL LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
RISPERIDONE, RISPERIDONE

ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE
PROCTER AND GAMBLE * PROCTER AND GAMBLE PHARMACEUTICALS INC SUB PROCTER AND GAMBLE CO DIDRONEL, ETIDRONATE DISODIUM PROGENICS * PROGENICS PHARMACEUTICALS INC RELISTOR, METHYLNALTREXONE BROMIDE PROMETHEUS LABS * PROMETHEUS LABORATORIES INC HELIDAC, BISMUTH SUBSALICYLATE IMURAN, AZATHIOPRINE LOTRONEX, ALOSETRON HYDROCHLORIDE MERCAPTOPURINE, MERCAPTOPURINE RIDAURA, AURANOFIN
TRANDATE, LABETALOL HYDROCHLORIDE

ZYLOPRIM, ALLOPURINOL

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

B - 108

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** P **

PROMIUS PHARMA * PROMIUS PHARMA LLC

SECTRAL, ACEBUTOLOL HYDROCHLORIDE

TENEX, GUANFACINE HYDROCHLORIDE
PROMIUS PHARMA LLC * PROMIUS PHARMA LLC CLODERM, CLOCORTOLONE PIVALATE PROSAM LABS * PROSAM LABS LLC BACLOFEN, BACLOFEN CARISOPRODOL AND ASPIRIN, ASPIRIN CARISOPRODOL, CARISOPRODOL CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE, ASPIRIN
CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE

DIPYRIDAMOLE, DIPYRIDAMOLE
PROSTRAKAN INC * PROSTRAKAN INC ABSTRAL, FENTANYL CITRATE
RECTIV, NITROGLYCERIN

SANCUSO, GRANISETRON
PROVIDENT PHARM * PROVIDENT PHARMACEUTICAL INC METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE PULSION MEDCL * PULSION MEDICAL SYSTEMS AG INDOCYANINE GREEN, INDOCYANINE GREEN PURACAP PHARM * PURACAP PHARMACEUTICAL LLC
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

MELOXICAM, MELOXICAM
PURDUE GMP * PURDUE GMP CENTER LLC DBA THE CHAO CENTER INDUSTRIAL PHARMACY SEROMYCIN, CYCLOSERINE PURDUE PHARM PRODS * PURDUE PHARMACEUTICAL PRODUCTS LP
DILAUDID, HYDROMORPHONE HYDROCHLORIDE

DILAUDID-HP, HYDROMORPHONE HYDROCHLORIDE
PURDUE PHARMA * PURDUE PHARMA PRODUCTS LP
INTERMEZZO, ZOLPIDEM TARTRATE

RYZOLT, TRAMADOL HYDROCHLORIDE
PURDUE PHARMA LP * PURDUE PHARMA LP BUTRANS, BUPRENORPHINE
MS CONTIN, MORPHINE SULFATE

OXYCONTIN, OXYCODONE HYDROCHLORIDE
PUREPAC PHARM * PUREPAC PHARMACEUTICAL CO DIPYRIDAMOLE, DIPYRIDAMOLE QLT * QLT INC VISUDYNE,

VERTEPORFIN

QOL MEDCL * QOL MEDICAL LLC ELLIOTTS B SOLUTION, CALCIUM CHLORIDE

ETHAMOLIN, ETHANOLAMINE OLEATE

SUCRAID, SACROSIDASE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

B - 109

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** Q **

QUESTCOR PHARMS * QUESTCOR PHARMACEUTICALS INC DORAL, QUAZEPAM H.P. ACTHAR GEL, CORTICOTROPIN RANBAXY * RANBAXY INC GLYCOPYRROLATE, GLYCOPYRROLATE * RANBAXY LABORATORIES INC EURAX, CROTAMITON EXELDERM, SULCONAZOLE NITRATE FAMOTIDINE, FAMOTIDINE (OTC) HALOG, HALCINONIDE KENALOG, TRIAMCINOLONE ACETONIDE LAC-HYDRIN, AMMONIUM LACTATE RISPERIDONE, RISPERIDONE
ULTRAVATE, HALOBETASOL PROPIONATE

WESTCORT, HYDROCORTISONE VALERATE
* RANBAXY LABORATORIES LTD ACYCLOVIR, ACYCLOVIR AMLODIPINE BESYLATE, AMLODIPINE BESYLATE AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN AMOXICILLIN, AMOXICILLIN BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE CARVEDILOL, CARVEDILOL CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE CEFPODOXIME PROXETIL, CEFPODOXIME PROXETIL CEFPROZIL, CEFPROZIL CEFUROXIME AXETIL, CEFUROXIME AXETIL CEPHALEXIN, CEPHALEXIN CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) CLARITHROMYCIN, CLARITHROMYCIN CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE CLORAZEPATE DIPOTASSIUM, CLORAZEPATE DIPOTASSIUM CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE DISPERMOX, AMOXICILLIN DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE DOXYCYCLINE, DOXYCYCLINE FENOFIBRATE, FENOFIBRATE FLECAINIDE ACETATE, FLECAINIDE ACETATE FLUCONAZOLE, FLUCONAZOLE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM FOSINOPRIL SODIUM, FOSINOPRIL SODIUM GABAPENTIN, GABAPENTIN GANCICLOVIR, GANCICLOVIR GLIMEPIRIDE, GLIMEPIRIDE LORATADINE AND PSEUDOEPHEDRINE SULFATE, LORATADINE (OTC) LORATADINE REDIDOSE, LORATADINE (OTC) LORATADINE, LORATADINE (OTC) LORAZEPAM, LORAZEPAM METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE NEFAZODONE HYDROCHLORIDE, NEFAZODONE HYDROCHLORIDE NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS), NITROFURANTOIN OFLOXACIN, OFLOXACIN
ONDANSETRON, ONDANSETRON

OXCARBAZEPINE, OXCARBAZEPINE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

B - 110

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** R **

* RANBAXY LABORATORIES LTD PRAVASTATIN SODIUM, PRAVASTATIN SODIUM PSEUDOEPHEDRINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (OTC) QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE RAMIPRIL, RAMIPRIL RANICLOR, CEFACLOR RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE RISPERIDONE, RISPERIDONE SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE SIMVASTATIN, SIMVASTATIN SOTRET, ISOTRETINOIN SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE TERAZOSIN HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE TOPIRAMATE, TOPIRAMATE VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE ZIDOVUDINE, ZIDOVUDINE

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

* RANBAXY PHARMACEUTICALS INC ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN AMOXICILLIN, AMOXICILLIN AVENTYL HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE CEFACLOR, CEFACLOR CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LISINOPRIL, LISINOPRIL LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE, LOPERAMIDE HYDROCHLORIDE (OTC) PENTAZOCINE AND NALOXONE HYDROCHLORIDES, NALOXONE HYDROCHLORIDE RIOMET, METFORMIN HYDROCHLORIDE

SOTRET, ISOTRETINOIN

RANBAXY LABS LTD * RANBAXY LABORATORIES LIMITED NAPROXEN SODIUM, NAPROXEN SODIUM (OTC) * RANBAXY LABORATORIES LTD ACETAMINOPHEN, ACETAMINOPHEN (OTC) ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

RARE DIS * RARE DISEASE THERAPEUTICS INC ORFADIN, NITISINONE RARE DIS THERAP * RARE DISEASE THERAPEUTICS INC CYSTADANE, BETAINE HYDROCHLORIDE RECIP * RECIP AB THYROSAFE,

POTASSIUM IODIDE

(OTC)

RECKITT BENCKISER * RECKITT BENCKISER DELSYM, DEXTROMETHORPHAN POLISTIREX (OTC) * RECKITT BENCKISER INC MUCINEX D, GUAIFENESIN (OTC) MUCINEX DM, DEXTROMETHORPHAN HYDROBROMIDE (OTC)

MUCINEX, GUAIFENESIN (OTC)

* RECKITT BENCKISER PHARMACEUTICALS INC BUPRENEX, BUPRENORPHINE HYDROCHLORIDE SUBOXONE, BUPRENORPHINE SUBOXONE, BUPRENORPHINE HYDROCHLORIDE

SUBUTEX, BUPRENORPHINE HYDROCHLORIDE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** R **

REDDYS * DOCTOR REDDYS LABORATORIES LTD DESLORATADINE, DESLORATADINE RHODES PHARMS * RHODES PHARMACEUTICALS LP
MORPHINE SULFATE, MORPHINE SULFATE

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
RHODIA * RHODIA LTD ISOFLURANE,

ISOFLURANE

RITEDOSE CORP * THE RITEDOSE CORP

ALBUTEROL SULFATE, ALBUTEROL SULFATE

IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE
ROCHE * HOFFMANN LA ROCHE INC BONIVA, IBANDRONATE SODIUM COPEGUS, RIBAVIRIN FUZEON, ENFUVIRTIDE INVIRASE, SAQUINAVIR MESYLATE KLONOPIN, CLONAZEPAM
TAMIFLU, OSELTAMIVIR PHOSPHATE

VALIUM, DIAZEPAM
ROCHE PALO * ROCHE PALO ALTO LLC AEROBID, FLUNISOLIDE ANAPROX DS, NAPROXEN SODIUM ANAPROX, NAPROXEN SODIUM CELLCEPT, MYCOPHENOLATE MOFETIL CELLCEPT, MYCOPHENOLATE MOFETIL HYDROCHLORIDE CYTOVENE, GANCICLOVIR SODIUM EC-NAPROSYN, NAPROXEN
NAPROSYN, NAPROXEN

VALCYTE, VALGANCICLOVIR HYDROCHLORIDE
ROCKWELL MEDCL * ROCKWELL MEDICAL TECHNOLOGIES INC CALCITRIOL, CALCITRIOL ROMARK * ROMARK LABORATORIES ALINIA, NITAZOXANIDE ROSEDALE THERAPEUTIC * ROSEDALE THERAPEUTICS ERGOMAR, ERGOTAMINE TARTRATE ROSS LABS * ROSS LABORATORIES DIV ABBOTT LABORATORIES INC SURVANTA, BERACTANT ROXANE * ROXANE LABORATORIES INC ACARBOSE, ACARBOSE ALPRAZOLAM, ALPRAZOLAM AMLODIPINE BESYLATE, AMLODIPINE BESYLATE ANASTROZOLE, ANASTROZOLE AZATHIOPRINE, AZATHIOPRINE BALSALAZIDE DISODIUM, BALSALAZIDE DISODIUM BICALUTAMIDE, BICALUTAMIDE BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE CALCITRIOL, CALCITRIOL
CALCIUM ACETATE, CALCIUM ACETATE

CILOSTAZOL, CILOSTAZOL

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** R **

* ROXANE LABORATORIES INC CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE CLARITHROMYCIN, CLARITHROMYCIN CLOTRIMAZOLE, CLOTRIMAZOLE CODEINE SULFATE, CODEINE SULFATE CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE DEXAMETHASONE INTENSOL, DEXAMETHASONE DEXAMETHASONE, DEXAMETHASONE DIAZEPAM INTENSOL, DIAZEPAM DIAZEPAM, DIAZEPAM DIGOXIN, DIGOXIN DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE DOLOPHINE HYDROCHLORIDE, METHADONE HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE DOXERCALCIFEROL, DOXERCALCIFEROL EXEMESTANE, EXEMESTANE FAMCICLOVIR, FAMCICLOVIR FLECAINIDE ACETATE, FLECAINIDE ACETATE FLUCONAZOLE, FLUCONAZOLE FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE FUROSEMIDE, FUROSEMIDE GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE IMIPRAMINE PAMOATE, IMIPRAMINE PAMOATE IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE LACTULOSE, LACTULOSE LETROZOLE, LETROZOLE LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM LEVETIRACETAM, LEVETIRACETAM LEVORPHANOL TARTRATE, LEVORPHANOL TARTRATE LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE LIDOCAINE VISCOUS, LIDOCAINE HYDROCHLORIDE LITHIUM CARBONATE, LITHIUM CARBONATE LITHIUM CITRATE, LITHIUM CITRATE LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC) LORAZEPAM INTENSOL, LORAZEPAM LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM, LOSARTAN POTASSIUM MEFLOQUINE HYDROCHLORIDE, MEFLOQUINE HYDROCHLORIDE MEGESTROL ACETATE, MEGESTROL ACETATE MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE MERCAPTOPURINE, MERCAPTOPURINE METHADONE HYDROCHLORIDE INTENSOL, METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE METHOTREXATE SODIUM, METHOTREXATE SODIUM MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE MORPHINE SULFATE, MORPHINE SULFATE MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL NAPROXEN, NAPROXEN NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE OXCARBAZEPINE, OXCARBAZEPINE OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE PERINDOPRIL ERBUMINE, PERINDOPRIL ERBUMINE PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE PREDNISONE INTENSOL, PREDNISONE PREDNISONE, PREDNISONE PROPANTHELINE BROMIDE, PROPANTHELINE BROMIDE PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE PROTRIPTYLINE HYDROCHLORIDE, PROTRIPTYLINE HYDROCHLORIDE RAMIPRIL, RAMIPRIL
RISPERIDONE, RISPERIDONE

ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** R **

* ROXANE LABORATORIES INC ROXICET 5/500, ACETAMINOPHEN ROXICET, ACETAMINOPHEN ROXILOX, ACETAMINOPHEN SODIUM POLYSTYRENE SULFONATE, SODIUM POLYSTYRENE SULFONATE TORSEMIDE, TORSEMIDE TRIAZOLAM, TRIAZOLAM VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE ZALEPLON, ZALEPLON ZIDOVUDINE, ZIDOVUDINE

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

SAGE PRODS * SAGE PRODUCTS INC CHLORHEXIDINE GLUCONATE,

CHLORHEXIDINE GLUCONATE

(OTC)

SAGENT PHARMS * SAGENT PHARMACEUTICALS INC CALCITRIOL, CALCITRIOL HALOPERIDOL, HALOPERIDOL LACTATE HEPARIN SODIUM PRESERVATIVE FREE, HEPARIN SODIUM HEPARIN SODIUM, HEPARIN SODIUM LEVOFLOXACIN, LEVOFLOXACIN ORPHENADRINE CITRATE, ORPHENADRINE CITRATE

TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE

SAGENT STRIDES * SAGENT STRIDES LLC AZITHROMYCIN, AZITHROMYCIN BACITRACIN, BACITRACIN BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE LABETALOL HYDROCLORIDE, LABETALOL HYDROCHLORIDE MESNA, MESNA METOPROLOL TARTRATE, METOPROLOL TARTRATE MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE, MIDAZOLAM HYDROCHLORIDE MIDOZALAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE POLYMYCIN B SULFATE, POLYMYXIN B SULFATE
ROCURONIUM BROMIDE, ROCURONIUM BROMIDE

SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
SALIX PHARMS * SALIX PHARMACEUTICALS INC ANUSOL HC, HYDROCORTISONE APRISO, MESALAMINE COLAZAL, BALSALAZIDE DISODIUM DIURIL, CHLOROTHIAZIDE METOZOLV ODT, METOCLOPRAMIDE HYDROCHLORIDE MOVIPREP, ASCORBIC ACID OSMOPREP, SODIUM PHOSPHATE, DIBASIC, ANHYDROUS PEPCID, FAMOTIDINE
VISICOL, SODIUM PHOSPHATE, DIBASIC ANHYDROUS

XIFAXAN, RIFAXIMIN
SAMSON MEDCL * SAMSON MEDICAL TECHNOLOGIES LLC
CEFAZOLIN SODIUM, CEFAZOLIN SODIUM
CEFUROXIME SODIUM IN PLASTIC CONTAINER,

CEFUROXIME SODIUM

SANDOZ * SANDOZ DOCETAXEL, DOCETAXEL * SANDOZ CANADA INC ANECTINE, SUCCINYLCHOLINE CHLORIDE
ARISTOSPAN, TRIAMCINOLONE HEXACETONIDE

BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** S **

* SANDOZ CANADA INC COSYNTROPIN, COSYNTROPIN DIGOXIN, DIGOXIN DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE ESTRADIOL VALERATE, ESTRADIOL VALERATE FENOLDOPAM MESYLATE, FENOLDOPAM MESYLATE FLUMAZENIL, FLUMAZENIL GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE INFUVITE ADULT, ALPHA-TOCOPHEROL ACETATE INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE), ASCORBIC ACID INFUVITE PEDIATRIC, ASCORBIC ACID ISONIAZID, ISONIAZID KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE MEDROXYPROGESTERONE ACETATE, MEDROXYPROGESTERONE ACETATE METHYLPREDNISOLONE ACETATE, METHYLPREDNISOLONE ACETATE METOPROLOL TARTRATE, METOPROLOL TARTRATE ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE REGONOL, PYRIDOSTIGMINE BROMIDE ROCURONIUM BROMIDE, ROCURONIUM BROMIDE SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

* SANDOZ INC ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE ALPRAZOLAM, ALPRAZOLAM ALTAVERA, ETHINYL ESTRADIOL AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN AMOXICILLIN, AMOXICILLIN AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM AMPICILLIN SODIUM, AMPICILLIN SODIUM AMPICILLIN TRIHYDRATE, AMPICILLIN/AMPICILLIN TRIHYDRATE ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE ANASTROZOLE, ANASTROZOLE ARGATROBAN IN SODIUM CHLORIDE, ARGATROBAN ATENOLOL, ATENOLOL ATOMOXETINE HYDROCHLORIDE, ATOMOXETINE HYDROCHLORIDE AZITHROMYCIN, AZITHROMYCIN BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE BICALUTAMIDE, BICALUTAMIDE BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE, BISOPROLOL FUMARATE BISOPROLOL FUMARATE, BISOPROLOL FUMARATE BUMETANIDE, BUMETANIDE BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE CAFERGOT, CAFFEINE CAPTOPRIL, CAPTOPRIL CARBOPLATIN, CARBOPLATIN CARISOPRODOL AND ASPIRIN, ASPIRIN CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE, ASPIRIN CARVEDILOL, CARVEDILOL CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE CEFAZOLIN SODIUM, CEFAZOLIN SODIUM CEFDINIR, CEFDINIR CEFEPIME HYDROCHLORIDE, CEFEPIME HYDROCHLORIDE CEFPODOXIME PROXETIL, CEFPODOXIME PROXETIL CEFPROZIL, CEFPROZIL
CEFTRIAXONE, CEFTRIAXONE SODIUM

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** S **

* SANDOZ INC CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE (OTC) CHLORPROMAZINE HYDROCHLORIDE, CHLORPROMAZINE HYDROCHLORIDE CHOLESTYRAMINE LIGHT, CHOLESTYRAMINE CHOLESTYRAMINE, CHOLESTYRAMINE CILOSTAZOL, CILOSTAZOL CIMETIDINE, CIMETIDINE CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE CLARITHROMYCIN, CLARITHROMYCIN CLEMASTINE FUMARATE, CLEMASTINE FUMARATE CLEMASTINE FUMARATE, CLEMASTINE FUMARATE (OTC) CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE CLONAZEPAM, CLONAZEPAM CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE CYCLOSPORINE, CYCLOSPORINE DESIPRAMINE HYDROCHLORIDE, DESIPRAMINE HYDROCHLORIDE DESLORATADINE, DESLORATADINE DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE ASPARTATE

DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM

DICLOFENAC SODIUM, DICLOFENAC SODIUM

DICLOXACILLIN SODIUM, DICLOXACILLIN SODIUM

DIVALPROEX SODIUM, DIVALPROEX SODIUM

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE

DOXYCYCLINE, DOXYCYCLINE

ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE

ENALAPRIL MALEATE, ENALAPRIL MALEATE

ENOXAPARIN SODIUM (PRESERVATIVE FREE), ENOXAPARIN SODIUM

EPLERENONE, EPLERENONE

ETODOLAC, ETODOLAC

FAMOTIDINE, FAMOTIDINE

FAMOTIDINE, FAMOTIDINE (OTC)

FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE

FLUOROURACIL, FLUOROURACIL

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE

FLUTAMIDE, FLUTAMIDE

FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM

FOSINOPRIL SODIUM, FOSINOPRIL SODIUM

FUROSEMIDE, FUROSEMIDE

GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE

GLIPIZIDE, GLIPIZIDE

HALOPERIDOL, HALOPERIDOL

HEPARIN SODIUM, HEPARIN SODIUM

HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE

HYDROXYZINE PAMOATE, HYDROXYZINE PAMOATE

IDARUBICIN HYDROCHLORIDE, IDARUBICIN HYDROCHLORIDE

IMIPRAMINE HYDROCHLORIDE, IMIPRAMINE HYDROCHLORIDE

INDAPAMIDE, INDAPAMIDE

INDOMETHACIN, INDOMETHACIN

INTROVALE, ETHINYL ESTRADIOL

INVAGESIC FORTE, ASPIRIN

INVAGESIC, ASPIRIN

ISONIAZID, ISONIAZID

ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE

ITRACONAZOLE, ITRACONAZOLE

LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE

LAMOTRIGINE, LAMOTRIGINE

LANSOPRAZOLE, LANSOPRAZOLE

LEFLUNOMIDE, LEFLUNOMIDE

LEUPROLIDE ACETATE, LEUPROLIDE ACETATE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** S **

* SANDOZ INC LEVETIRACETAM, LEVETIRACETAM LEVOFLOXACIN, LEVOFLOXACIN LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LISINOPRIL, LISINOPRIL LOCHOLEST LIGHT, CHOLESTYRAMINE LOCHOLEST, CHOLESTYRAMINE LONOX, ATROPINE SULFATE LORATADINE, LORATADINE (OTC) LORAZEPAM, LORAZEPAM LORYNA, DROSPIRENONE LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM, LOSARTAN POTASSIUM LOVASTATIN, LOVASTATIN MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE MEFLOQUINE HYDROCHLORIDE, MEFLOQUINE HYDROCHLORIDE MEROPENEM, MEROPENEM METAXALONE, METAXALONE METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE METHAZOLAMIDE, METHAZOLAMIDE METHIMAZOLE, METHIMAZOLE METHOCARBAMOL, METHOCARBAMOL METHYLPREDNISOLONE, METHYLPREDNISOLONE METOLAZONE, METOLAZONE METOPROLOL SUCCINATE, METOPROLOL SUCCINATE METOPROLOL TARTRATE, METOPROLOL TARTRATE MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE MIRTAZAPINE, MIRTAZAPINE MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL NABUMETONE, NABUMETONE NADOLOL, NADOLOL NAFCILLIN SODIUM, NAFCILLIN SODIUM NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE NAPROXEN SODIUM, NAPROXEN SODIUM (OTC) NAPROXEN, NAPROXEN NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS), NITROFURANTOIN NIZATIDINE, NIZATIDINE OFLOXACIN, OFLOXACIN OMEPRAZOLE, OMEPRAZOLE OMNITROPE, SOMATROPIN RECOMBINANT ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE ONDANSETRON, ONDANSETRON ORPHENADRINE CITRATE, ORPHENADRINE CITRATE ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE, ASPIRIN OXACILLIN SODIUM, OXACILLIN SODIUM OXALIPLATIN, OXALIPLATIN OXANDROLONE, OXANDROLONE OXAPROZIN, OXAPROZIN OXAZEPAM, OXAZEPAM PENICILLIN G POTASSIUM, PENICILLIN G POTASSIUM PENICILLIN G SODIUM, PENICILLIN G SODIUM PENICILLIN V POTASSIUM, PENICILLIN V POTASSIUM PERPHENAZINE, PERPHENAZINE PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE PROCHLORPERAZINE MALEATE, PROCHLORPERAZINE MALEATE PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE

QUINIDINE SULFATE, QUINIDINE SULFATE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** S **

* SANDOZ INC RAMIPRIL, RAMIPRIL RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE RESERPINE, RESERPINE RIBAVIRIN, RIBAVIRIN RIFAMPIN, RIFAMPIN RISPERIDONE, RISPERIDONE SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE SPIRONOLACTONE, SPIRONOLACTONE SULFADIAZINE, SULFADIAZINE SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH, SULFAMETHOXAZOLE SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE SYEDA, DROSPIRENONE TACROLIMUS, TACROLIMUS TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE TEMAZEPAM, TEMAZEPAM TERAZOSIN HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE THIOTHIXENE, THIOTHIXENE TICLOPIDINE HYDROCHLORIDE, TICLOPIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE TOPIRAMATE, TOPIRAMATE TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE TRIFLUOPERAZINE HYDROCHLORIDE, TRIFLUOPERAZINE HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

ZONISAMIDE, ZONISAMIDE

SANDOZ CANADA INC * SANDOZ CANADA INC PARICALCITOL, PARICALCITOL SANDOZ INC * SANDOZ INC DOCETAXEL, DOCETAXEL ENOXAPARIN SODIUM, ENOXAPARIN SODIUM

VORICONAZOLE, VORICONAZOLE

SANOCHEMIA CORP USA * SANOCHEMIA CORP USA SCANLUX-300, IOPAMIDOL

SCANLUX-370, IOPAMIDOL

SANOFI AVENTIS * SANOFI AVENTIS AVALIDE, HYDROCHLOROTHIAZIDE SANOFI AVENTIS US * SANOFI AVENTIS US INC JEVTANA KIT, CABAZITAXEL * SANOFI AVENTIS US LLC ALLEGRA ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC) ALLEGRA HIVES, FEXOFENADINE HYDROCHLORIDE (OTC) ALLEGRA, FEXOFENADINE HYDROCHLORIDE ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION, FEXOFENADINE HYDROCHLORIDE ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION, FEXOFENADINE HYDROCHLORIDE AMARYL, GLIMEPIRIDE AMBIEN CR, ZOLPIDEM TARTRATE AMBIEN, ZOLPIDEM TARTRATE ANZEMET, DOLASETRON MESYLATE APIDRA SOLOSTAR, INSULIN GLULISINE RECOMBINANT APIDRA, INSULIN GLULISINE RECOMBINANT ARALEN, CHLOROQUINE PHOSPHATE ARAVA, LEFLUNOMIDE AVAPRO, IRBESARTAN

BENZACLIN, BENZOYL PEROXIDE

(OTC) (OTC)

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** S **

* SANOFI AVENTIS US LLC BENZAMYCIN PAK, BENZOYL PEROXIDE BENZAMYCIN, BENZOYL PEROXIDE CANTIL, MEPENZOLATE BROMIDE CARAC, FLUOROURACIL CHILDREN'S ALLEGRA ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC) CHILDREN'S ALLEGRA HIVES, FEXOFENADINE HYDROCHLORIDE (OTC) CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER, CEFOTAXIME SODIUM CLAFORAN, CEFOTAXIME SODIUM CLOMID, CLOMIPHENE CITRATE DDAVP (NEEDS NO REFRIGERATION), DESMOPRESSIN ACETATE DDAVP, DESMOPRESSIN ACETATE DEMEROL, MEPERIDINE HYDROCHLORIDE DERMATOP E EMOLLIENT, PREDNICARBATE DERMATOP, PREDNICARBATE DIABETA, GLYBURIDE DRISDOL, ERGOCALCIFEROL ELOXATIN, OXALIPLATIN FERRLECIT, SODIUM FERRIC GLUCONATE COMPLEX GAVISCON, ALUMINUM HYDROXIDE (OTC) HIPREX, METHENAMINE HIPPURATE KAYEXALATE, SODIUM POLYSTYRENE SULFONATE KETEK, TELITHROMYCIN KLARON, SULFACETAMIDE SODIUM LANTUS, INSULIN GLARGINE RECOMBINANT LASIX, FUROSEMIDE LOVENOX (PRESERVATIVE FREE), ENOXAPARIN SODIUM LOVENOX, ENOXAPARIN SODIUM MULTAQ, DRONEDARONE HYDROCHLORIDE MYTELASE, AMBENONIUM CHLORIDE NASACORT AQ, TRIAMCINOLONE ACETONIDE NICODERM CQ, NICOTINE (OTC) NILANDRON, NILUTAMIDE NORITATE, METRONIDAZOLE NORPRAMIN, DESIPRAMINE HYDROCHLORIDE OFORTA, FLUDARABINE PHOSPHATE PENLAC, CICLOPIROX PHISOHEX, HEXACHLOROPHENE PLAQUENIL, HYDROXYCHLOROQUINE SULFATE PLAVIX, CLOPIDOGREL BISULFATE PRIFTIN, RIFAPENTINE PRIMAQUINE, PRIMAQUINE PHOSPHATE RIFADIN, RIFAMPIN RIFAMATE, ISONIAZID RIFATER, ISONIAZID RILUTEK, RILUZOLE SKELID, TILUDRONATE DISODIUM TAXOTERE, DOCETAXEL
TRENTAL, PENTOXIFYLLINE

UROXATRAL, ALFUZOSIN HYDROCHLORIDE
SANTARUS * SANTARUS INC FENOGLIDE, FENOFIBRATE GLUMETZA, METFORMIN HYDROCHLORIDE MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE, ZEGERID, OMEPRAZOLE SANTEN * SANTEN INC ALAMAST, PEMIROLAST POTASSIUM
IQUIX, LEVOFLOXACIN

QUIXIN, LEVOFLOXACIN

MAGNESIUM HYDROXIDE

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APPENDIX B
SANTEN OY * SANTEN OY BETIMOL,

PRODUCT NAME SORTED BY APPLICANT

** S **

TIMOLOL

SANTOS BIOTECH * SANTOS BIOTECH INDUSTRIES INC ANASTROZOLE, ANASTROZOLE SAVAGE LABS * SAVAGE LABORATORIES INC DIV ALTANA INC KAON CL-10, POTASSIUM CHLORIDE SAVIENT PHARMS * SAVIENT PHARMACEUTICALS INC OXANDRIN, OXANDROLONE SB PHARMCO * SB PHARMCO PUERTO RICO INC AVANDAMET, METFORMIN HYDROCHLORIDE AVANDARYL, GLIMEPIRIDE
AVANDIA, ROSIGLITAZONE MALEATE

COREG CR, CARVEDILOL PHOSPHATE
SCHERING * MERCK, INC. CLARINEX D 24 HOUR, DESLORATADINE * SCHERING CLARINEX-D 12 HOUR, DESLORATADINE * SCHERING CORP ASMANEX TWISTHALER, MOMETASONE FUROATE CLARINEX, DESLORATADINE DIPROLENE AF, BETAMETHASONE DIPROPIONATE DULERA, FORMOTEROL FUMARATE GUANIDINE HYDROCHLORIDE, GUANIDINE HYDROCHLORIDE INTEGRILIN, EPTIFIBATIDE LOTRISONE, BETAMETHASONE DIPROPIONATE NOXAFIL, POSACONAZOLE POTASSIUM CHLORIDE, POTASSIUM CHLORIDE REBETOL, RIBAVIRIN TEMODAR, TEMOZOLOMIDE
VICTRELIS, BOCEPREVIR

ZEMURON, ROCURONIUM BROMIDE
* SCHERING CORP SUB SCHERING PLOUGH CORP CELESTONE SOLUSPAN, BETAMETHASONE ACETATE CELESTONE, BETAMETHASONE
DIPROLENE, BETAMETHASONE DIPROPIONATE

ELOCON, MOMETASONE FUROATE
SCHERING PLOUGH * SCHERING PLOUGH CORP CLARINEX, DESLORATADINE * SCHERING PLOUGH HEALTHCARE PRODUCTS INC AFRINOL, PSEUDOEPHEDRINE SULFATE (OTC) CHILDREN'S CLARITIN, LORATADINE (OTC) CHLOR-TRIMETON, CHLORPHENIRAMINE MALEATE (OTC) CLARITIN HIVES RELIEF REDITAB, LORATADINE (OTC) CLARITIN HIVES RELIEF, LORATADINE (OTC) CLARITIN REDITABS, LORATADINE (OTC) CLARITIN, LORATADINE (OTC) CLARITIN-D 24 HOUR, LORATADINE (OTC) CLARITIN-D, LORATADINE (OTC) DISOPHROL, DEXBROMPHENIRAMINE MALEATE (OTC) DRIXORAL PLUS, ACETAMINOPHEN (OTC) DRIXORAL, DEXBROMPHENIRAMINE MALEATE (OTC) GYNE-LOTRIMIN 3 COMBINATION PACK, CLOTRIMAZOLE (OTC) GYNE-LOTRIMIN 3, CLOTRIMAZOLE (OTC)
GYNE-LOTRIMIN COMBINATION PACK, CLOTRIMAZOLE (OTC)

GYNE-LOTRIMIN, CLOTRIMAZOLE (OTC)

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** S **

* SCHERING PLOUGH HEALTHCARE PRODUCTS INC LOTRIMIN ULTRA, BUTENAFINE HYDROCHLORIDE (OTC) MIRALAX, POLYETHYLENE GLYCOL 3350 (OTC) NASONEX, MOMETASONE FUROATE MONOHYDRATE OCUCLEAR, OXYMETAZOLINE HYDROCHLORIDE (OTC)

SHADE UVAGUARD, AVOBENZONE (OTC)

SCHERING PLOUGH RES * SCHERING PLOUGH RESEARCH INSTITUTE LOTRISONE, BETAMETHASONE DIPROPIONATE

REBETOL, RIBAVIRIN

SCHWARZ PHARMA * SCHWARZ PHARMA AG EDEX, ALPROSTADIL * SCHWARZ PHARMA INC DILATRATE-SR, ISOSORBIDE DINITRATE LEVATOL, PENBUTOLOL SULFATE NIRAVAM, ALPRAZOLAM PARCOPA, CARBIDOPA ROBAXIN, METHOCARBAMOL

ROBAXIN-750, METHOCARBAMOL

SCIOS * SCIOS INC NATRECOR,

NESIRITIDE RECOMBINANT

SECAN PHARMS * SECAN PHARMACEUTICALS INC AMLODIPINE BESYLATE, AMLODIPINE BESYLATE SEPTODONT * SEPTODONT INC BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE, OCTOCAINE, EPINEPHRINE
SEPTODONT HOLDING * SEPTODONT HOLDING SAS ORAVERSE, PHENTOLAMINE MESYLATE SEPTODONT INC * SEPTODONT INC PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE, PRILOCAINE HYDROCHLORIDE, PRILOCAINE HYDROCHLORIDE SHASUN USA * SHASUN USA INC IBUPROFEN, IBUPROFEN SHIONOGI INC * SHIONOGI INC ADRENACLICK, EPINEPHRINE CUVPOSA, GLYCOPYRROLATE FURADANTIN, NITROFURANTOIN KAPVAY, CLONIDINE HYDROCHLORIDE KEFLEX, CEPHALEXIN MOXATAG, AMOXICILLIN ORAPRED ODT, PREDNISOLONE SODIUM PHOSPHATE ORAPRED, PREDNISOLONE SODIUM PHOSPHATE PONSTEL, MEFENAMIC ACID ROBINUL FORTE, GLYCOPYRROLATE ROBINUL, GLYCOPYRROLATE SULAR, NISOLDIPINE TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE TWINJECT 0.15, EPINEPHRINE
TWINJECT 0.3, EPINEPHRINE

ULESFIA, BENZYL ALCOHOL

BUPIVACAINE HYDROCHLORIDE

EPINEPHRINE BITARTRATE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** S **

SHIRE * SHIRE DEVELOPMENT INC ADDERALL XR 10, AMPHETAMINE ASPARTATE ADDERALL XR 15, AMPHETAMINE ASPARTATE ADDERALL XR 20, AMPHETAMINE ASPARTATE ADDERALL XR 25, AMPHETAMINE ASPARTATE ADDERALL XR 30, AMPHETAMINE ASPARTATE ADDERALL XR 5, AMPHETAMINE ASPARTATE AGRYLIN, ANAGRELIDE HYDROCHLORIDE CARBATROL, CARBAMAZEPINE FOSRENOL, LANTHANUM CARBONATE INTUNIV, GUANFACINE HYDROCHLORIDE LIALDA, MESALAMINE PENTASA, MESALAMINE
PROAMATINE, MIDODRINE HYDROCHLORIDE

SALURON, HYDROFLUMETHIAZIDE
SHIRE DEVELOPMENT * SHIRE DEVELOPMENT INC VYVANSE, LISDEXAMFETAMINE DIMESYLATE SHIRE HUMAN GENETIC * SHIRE HUMAN GENETIC THERAPIES INC VPRIV, VELAGLUCERASE ALFA SHIRE ORPHAN THERAP * SHIRE ORPHAN THERAPIES INC FIRAZYR, ICATIBANT ACETATE SIGMA TAU * SIGMA TAU PHARMACEUTICALS INC ABELCET, AMPHOTERICIN B ADAGEN, PEGADEMASE BOVINE CARNITOR SF, LEVOCARNITINE
CARNITOR, LEVOCARNITINE

MATULANE, PROCARBAZINE HYDROCHLORIDE
SIGMAPHARM LABS LLC * SIGMAPHARM LABORATORIES LLC AMILORIDE HYDROCHLORIDE, AMILORIDE HYDROCHLORIDE DISULFIRAM, DISULFIRAM ERGOCALCIFEROL, ERGOCALCIFEROL
FLUCYTOSINE, FLUCYTOSINE

PROTRIPTYLINE HYDROCHLORIDE, PROTRIPTYLINE HYDROCHLORIDE
SILARX * SILARX PHARMACEUTICALS INC AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE CLEMASTINE FUMARATE, CLEMASTINE FUMARATE DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE HALOPERIDOL, HALOPERIDOL LACTATE LEVETIRACETAM, LEVETIRACETAM LORATADINE, LORATADINE (OTC) METAPROTERENOL SULFATE, METAPROTERENOL SULFATE METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

THEOPHYLLINE, THEOPHYLLINE
SKINMEDICA * SKINMEDICA INC VANIQA, EFLORNITHINE HYDROCHLORIDE

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APPENDIX B
SKYEPHARMA AG * SKYEPHARMA AG TRIGLIDE, FENOFIBRATE SLATE PHARMS * SLATE PHARMACEUTICALS INC TESTOPEL, TESTOSTERONE

PRODUCT NAME SORTED BY APPLICANT

** S **

SMITHKLINE BEECHAM * SMITHKLINE BEECHAM LOVAZA, OMEGA-3-ACID ETHYL ESTERS * SMITHKLINE BEECHAM CORP LAMICTAL XR, LAMOTRIGINE * SMITHKLINE BEECHAM CORP DBA GLAXOSMITHKLINE ARRANON, NELARABINE AXID, NIZATIDINE COREG, CARVEDILOL HYCAMTIN, TOPOTECAN HYDROCHLORIDE LAMICTAL ODT, LAMOTRIGINE
REQUIP XL, ROPINIROLE HYDROCHLORIDE

TYKERB, LAPATINIB DITOSYLATE
SOAPCO * SOAPCO INC BRIAN CARE,

CHLORHEXIDINE GLUCONATE

(OTC)

SOLCO HLTHCARE * SOLCO HEALTHCARE US LLC LEVETIRACETAM, LEVETIRACETAM SOMAXON * SOMAXON PHARMACEUTICALS INC SILENOR, DOXEPIN HYDROCHLORIDE SOMERSET * SOMERSET PHARMACEUTICALS INC
ELDEPRYL, SELEGILINE HYDROCHLORIDE

EMSAM, SELEGILINE
SPEAR PHARMS * SPEAR PHARMACEUTICALS INC
FLUOROURACIL, FLUOROURACIL

TRETINOIN, TRETINOIN
SPECTRUM PHARMS * SPECTRUM PHARMACEUTICALS ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE * SPECTRUM PHARMACEUTICALS INC FUSILEV, LEVOLEUCOVORIN CALCIUM STAND HOMEOPATH * STANDARD HOMEOPATHIC CO IVY BLOCK, BENTOQUATAM STASON * STASON INDUSTRIAL CORP ACYCLOVIR, ACYCLOVIR
CAPTOPRIL, CAPTOPRIL
SELEGILINE HYDROCHLORIDE,

(OTC)

SELEGILINE HYDROCHLORIDE

STASON PHARMS * STASON PHARMACEUTICALS INC CYPROHEPTADINE HYDROCHLORIDE, STAT TRADE * STAT TRADE INC NAPRELAN, NAPROXEN SODIUM

CYPROHEPTADINE HYDROCHLORIDE

STERI PHARMA * STERI PHARMA LLC

CEFAZOLIN SODIUM, CEFAZOLIN SODIUM

CEFTRIAXONE, CEFTRIAXONE SODIUM

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APPENDIX B
* STERI PHARMA LLC CEFUROXIME SODIUM,

PRODUCT NAME SORTED BY APPLICANT

** S **

CEFUROXIME SODIUM

STEVENS J * JEROME STEVENS PHARMACEUTICALS INC BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE, ASPIRIN CEPHALEXIN, CEPHALEXIN DIGOXIN, DIGOXIN METHOCARBAMOL AND ASPIRIN, ASPIRIN ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE, ASPIRIN

UNITHROID, LEVOTHYROXINE SODIUM

STI PHARMA LLC * STI PHARMA LLC BETAMETHASONE VALERATE, BETAMETHASONE VALERATE DEXAMETHASONE, DEXAMETHASONE MYAMBUTOL, ETHAMBUTOL HYDROCHLORIDE

TRIACIN-C, CODEINE PHOSPHATE

STIEFEL * STIEFEL LABORATORIES INC DUAC, BENZOYL PEROXIDE STIEFEL GSK * STIEFEL A GSK CO VELTIN, CLINDAMYCIN PHOSPHATE STIEFEL LABS INC * STIEFEL LABORATORIES INC EVOCLIN, CLINDAMYCIN PHOSPHATE EXTINA, KETOCONAZOLE OLUX E, CLOBETASOL PROPIONATE OLUX, CLOBETASOL PROPIONATE ONMEL, ITRACONAZOLE SORIATANE, ACITRETIN SORILUX, CALCIPOTRIENE
VERDESO, DESONIDE

VUSION, MICONAZOLE NITRATE
STRIDES ARCOLAB * STRIDES ARCOLAB LIMITED FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM STRIDES ARCOLAB LTD * STRIDES ARCOLAB LTD ACARBOSE, ACARBOSE ADENOSINE, ADENOSINE ERGOCALCIFEROL, ERGOCALCIFEROL ETOMIDATE, ETOMIDATE LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE MELOXICAM, MELOXICAM
MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE
SUCAMPO PHARMS * SUCAMPO PHARMACEUTICALS INC AMITIZA, LUBIPROSTONE SUMMERS * SUMMERS LABORATORIES INC CROTAN, CROTAMITON SUN PHARM INDS * SUN PHARMACEUTICAL INDUSTRIES LTD CARBIDOPA AND LEVODOPA, CARBIDOPA DESLORATADINE, DESLORATADINE DIVALPROEX SODIUM, DIVALPROEX SODIUM
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

EPINASTINE HYDROCHLORIDE, EPINASTINE HYDROCHLORIDE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** S **

* SUN PHARMACEUTICAL INDUSTRIES LTD EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM OCTREOTIDE ACETATE, OCTREOTIDE ACETATE ONDANSETRON, ONDANSETRON OXCARBAZEPINE, OXCARBAZEPINE RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE TIAGABINE HYDROCHLORIDE, TIAGABINE HYDROCHLORIDE

TORSEMIDE, TORSEMIDE

SUN PHARM INDS (IN) * SUN PHARMACEUTICAL INDUSTRIES LTD CEPHALEXIN, CEPHALEXIN EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE ORTHO-EST, ESTROPIPATE SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

ZONISAMIDE, ZONISAMIDE

SUN PHARM INDS INC * SUN PHARMACEUTICAL INDUSTRIES INC BENZONATATE, BENZONATATE BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) ERGOCALCIFEROL, ERGOCALCIFEROL GEMFIBROZIL, GEMFIBROZIL HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE LITHIUM CARBONATE, LITHIUM CARBONATE NIMODIPINE, NIMODIPINE OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
VALPROIC ACID, VALPROIC ACID

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE
SUN PHARM INDS LTD * SUN PHARMACEUTICAL INDUSTRIES LTD CARISOPRODOL, CARISOPRODOL GABAPENTIN, GABAPENTIN LETROZOLE, LETROZOLE LEVETIRACETAM, LEVETIRACETAM NARATRIPTAN, NARATRIPTAN ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE
TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE

TOPIRAMATE, TOPIRAMATE
* SUN PHARMACEUTICAL INDUSTRIES LTD. ANASTROZOLE, ANASTROZOLE SUN PHARMA GLOBAL * SUN PHARMA GLOBAL FZE BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE CAFFEINE CITRATE, CAFFEINE CITRATE CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) CHLOROTHIAZIDE SODIUM, CHLOROTHIAZIDE SODIUM DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE DOCEFREZ, DOCETAXEL
FINASTERIDE, FINASTERIDE

GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** S **

* SUN PHARMA GLOBAL FZE OXALIPLATIN, OXALIPLATIN TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

* SUN PHARMA GLOBAL INC ALENDRONATE SODIUM, ALENDRONATE SODIUM ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE ALPRAZOLAM, ALPRAZOLAM AMIFOSTINE, AMIFOSTINE ATOMOXETINE HYDROCHLORIDE, ATOMOXETINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE BICALUTAMIDE, BICALUTAMIDE CARBOPLATIN, CARBOPLATIN FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE LEUPROLIDE ACETATE, LEUPROLIDE ACETATE NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

VECURONIUM BROMIDE, VECURONIUM BROMIDE

SUNOVION * SUNOVION PHARMACEUTICALS INC BROVANA, ARFORMOTEROL TARTRATE LATUDA, LURASIDONE HYDROCHLORIDE XOPENEX HFA, LEVALBUTEROL TARTRATE

XOPENEX, LEVALBUTEROL HYDROCHLORIDE

SUNOVION PHARMS INC * SUNOVION PHARMACEUTICALS INC LUNESTA, ESZOPICLONE SVADS HOLDINGS SA * SVADS HOLDINGS SA IBUPROFEN, IBUPROFEN (OTC)

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE SVC PHARMA * SVC PHARMA LP DRONABINOL,

(OTC)

DRONABINOL

SYNCOR PHARMS * SYNCOR PHARMACEUTICALS INC SODIUM IODIDE I 123, SODIUM IODIDE I-123 SYNERX * SYNERX PHARMA LLC ISOSULFAN BLUE, ISOSULFAN BLUE

MELPHALAN HYDROCHLORIDE, MELPHALAN HYDROCHLORIDE

SYNERX PHARMA * SYNERX PHARMA LLC CICLOPIROX, CICLOPIROX FOMEPIZOLE, FOMEPIZOLE MALATHION, MALATHION TESTOSTERONE CYPIONATE, TESTOSTERONE ENANTHATE,

TESTOSTERONE CYPIONATE

TESTOSTERONE ENANTHATE

SYNTHON PHARMS * SYNTHON PHARMACEUTICALS INC BICALUTAMIDE, BICALUTAMIDE LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

TAKEDA GLOBAL * TAKEDA GLOBAL RESEARCH DEVELOPMENT CENTER INC ACTOPLUS MET XR, METFORMIN HYDROCHLORIDE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** T **

* TAKEDA GLOBAL RESEARCH DEVELOPMENT CENTER INC ACTOPLUS MET, METFORMIN HYDROCHLORIDE DUETACT, GLIMEPIRIDE

ROZEREM, RAMELTEON

TAKEDA PHARMS * TAKEDA PHARMACEUTICALS NORTH AMERICA INC DEXILANT, DEXLANSOPRAZOLE EDARBI, AZILSARTAN KAMEDOXOMIL EDARBYCLOR, AZILSARTAN KAMEDOXOMIL

ULORIC, FEBUXOSTAT

TAKEDA PHARMS NA * TAKEDA PHARMACEUTICALS NORTH AMERICA INC ACTOS, PIOGLITAZONE HYDROCHLORIDE PREVACID, LANSOPRAZOLE

PREVPAC, AMOXICILLIN

TARO * TARO PHARMACEUTICAL INDUSTRIES LTD ACETAZOLAMIDE, ACETAZOLAMIDE CARBAMAZEPINE, CARBAMAZEPINE CARVEDILOL, CARVEDILOL CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE ENALAPRIL MALEATE, ENALAPRIL MALEATE ETODOLAC, ETODOLAC EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM FLUCONAZOLE, FLUCONAZOLE FLUOROURACIL, FLUOROURACIL HYDROCORTISONE BUTYRATE, HYDROCORTISONE BUTYRATE IMIQUIMOD, IMIQUIMOD KETOCONAZOLE, KETOCONAZOLE LAMOTRIGINE, LAMOTRIGINE LEVETIRACETAM, LEVETIRACETAM LORATADINE, LORATADINE (OTC) MELOXICAM, MELOXICAM MEPROBAMATE, MEPROBAMATE METRONIDAZOLE, METRONIDAZOLE NORTRIPTYLINE HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
OXCARBAZEPINE, OXCARBAZEPINE

PHENYTOIN, PHENYTOIN
* TARO PHARMACEUTICALS INC BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE CLOTRIMAZOLE, CLOTRIMAZOLE CLOTRIMAZOLE, CLOTRIMAZOLE (OTC) DESOXIMETASONE, DESOXIMETASONE DIFLORASONE DIACETATE, DIFLORASONE DIACETATE FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE FLUOCINONIDE, FLUOCINONIDE HYDROCORTISONE VALERATE, HYDROCORTISONE VALERATE MICONAZOLE NITRATE, MICONAZOLE NITRATE (OTC) NORTRIPTYLINE HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE
TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

WARFARIN SODIUM, WARFARIN SODIUM
* TARO PHARMACEUTICALS USA INC ACETIC ACID, ACETIC ACID, GLACIAL ALCLOMETASONE DIPROPIONATE, ALCLOMETASONE DIPROPIONATE
AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

AMMONIUM LACTATE, AMMONIUM LACTATE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** T **

* TARO PHARMACEUTICALS USA INC BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE CICLOPIROX, CICLOPIROX CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE CLOBETASOL PROPIONATE (EMOLLIENT), CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE CLORAZEPATE DIPOTASSIUM, CLORAZEPATE DIPOTASSIUM CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE CLOTRIMAZOLE, CLOTRIMAZOLE DERMABET, BETAMETHASONE VALERATE DESONIDE, DESONIDE DIFLORASONE DIACETATE, DIFLORASONE DIACETATE ECONAZOLE NITRATE, ECONAZOLE NITRATE FLO-PRED, PREDNISOLONE ACETATE FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE FLUOCINONIDE EMULSIFIED BASE, FLUOCINONIDE FLUOCINONIDE, FLUOCINONIDE FLUOROURACIL, FLUOROURACIL GENTAMICIN SULFATE, GENTAMICIN SULFATE GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE HYDROCORTISONE AND ACETIC ACID, ACETIC ACID, GLACIAL HYDROCORTISONE, HYDROCORTISONE KETOZOLE, KETOCONAZOLE LIDOCAINE, LIDOCAINE LORATADINE, LORATADINE (OTC) MICONAZOLE 3, MICONAZOLE NITRATE (OTC) MOMETASONE FUROATE, MOMETASONE FUROATE MUPIROCIN, MUPIROCIN NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN NYSTATIN, NYSTATIN PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE RISPERIDONE, RISPERIDONE SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE (OTC) TERCONAZOLE, TERCONAZOLE TERIL, CARBAMAZEPINE TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE
TRIVAGIZOLE 3, CLOTRIMAZOLE (OTC)
U-CORT, HYDROCORTISONE ACETATE

* TARO PHARMACEUTICALS, INC. DESOXIMETASONE, DESOXIMETASONE TARO PHARM INDS * TARO PHARMACEUTICAL INDUSTRIES LTD AMCINONIDE, AMCINONIDE CARBAMAZEPINE, CARBAMAZEPINE CICLOPIROX, CICLOPIROX CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE ETODOLAC, ETODOLAC FLUCONAZOLE, FLUCONAZOLE
HYDROCORTISONE BUTYRATE, HYDROCORTISONE BUTYRATE

LAMOTRIGINE, LAMOTRIGINE
TARO PHARMS IRELAND * TARO PHARMACEUTICALS IRELAND LTD ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION TARO PHARMS NORTH * TARO PHARMACEUTICALS NORTH AMERICA INC
OVIDE, MALATHION

TOPICORT LP, DESOXIMETASONE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** T **

* TARO PHARMACEUTICALS NORTH AMERICA INC TOPICORT, DESOXIMETASONE TAYLOR * TAYLOR PHARMACEUTICALS LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE LORAZEPAM, LORAZEPAM MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE

NAPHAZOLINE HYDROCHLORIDE, NAPHAZOLINE HYDROCHLORIDE

TAYLOR PHARMA * TAYLOR PHARMACAL CO DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE PROPARACAINE HYDROCHLORIDE, PROPARACAINE HYDROCHLORIDE

TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE, POLYMYXIN B SULFATE

TEDOR PHARM * TEDOR PHARMA INC BENZPHETAMINE HYDROCHLORIDE, TEIKOKU PHARMA USA * TEIKOKU PHARMA USA INC LIDODERM, LIDOCAINE TERCICA * TERCICA INC INCRELEX,

BENZPHETAMINE HYDROCHLORIDE

MECASERMIN RECOMBINANT

TEVA * TEVA NEUROSCIENCE INC

AZILECT, RASAGILINE MESYLATE

COPAXONE, GLATIRAMER ACETATE
* TEVA PHARMACEUTICALS USA INC ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN ACYCLOVIR, ACYCLOVIR ADIPEX-P, PHENTERMINE HYDROCHLORIDE ALBUTEROL SULFATE, ALBUTEROL SULFATE AMLODIPINE BESYLATE, AMLODIPINE BESYLATE AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN AMOXICILLIN PEDIATRIC, AMOXICILLIN AMOXICILLIN, AMOXICILLIN ATENOLOL, ATENOLOL AZITHROMYCIN, AZITHROMYCIN BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE BETA-VAL, BETAMETHASONE VALERATE BICALUTAMIDE, BICALUTAMIDE BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE CALCITRIOL, CALCITRIOL CAPTOPRIL AND HYDROCHLOROTHIAZIDE, CAPTOPRIL CAPTOPRIL, CAPTOPRIL CARBIDOPA AND LEVODOPA, CARBIDOPA CARVEDILOL, CARVEDILOL CEFACLOR, CEFACLOR CEFPROZIL, CEFPROZIL CEFTRIAXONE, CEFTRIAXONE SODIUM CEFUROXIME AXETIL, CEFUROXIME AXETIL CEFUROXIME SODIUM, CEFUROXIME SODIUM CEPHALEXIN, CEPHALEXIN CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC) CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC) CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE CILOSTAZOL, CILOSTAZOL CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE CIMETIDINE, CIMETIDINE
CLARITHROMYCIN, CLARITHROMYCIN

CLEMASTINE FUMARATE, CLEMASTINE FUMARATE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** T **

* TEVA PHARMACEUTICALS USA INC CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE CLONAZEPAM, CLONAZEPAM CLOTRIMAZOLE, CLOTRIMAZOLE DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM DICLOXACILLIN SODIUM, DICLOXACILLIN SODIUM DIFLUNISAL, DIFLUNISAL DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE DISOPYRAMIDE PHOSPHATE, DISOPYRAMIDE PHOSPHATE DIVALPROEX SODIUM, DIVALPROEX SODIUM DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE ENALAPRIL MALEATE, ENALAPRIL MALEATE EPITOL, CARBAMAZEPINE ESTAZOLAM, ESTAZOLAM ETODOLAC, ETODOLAC FAMOTIDINE, FAMOTIDINE FAMOTIDINE, FAMOTIDINE (OTC) FENOFIBRATE (MICRONIZED), FENOFIBRATE FENOFIBRATE, FENOFIBRATE FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC) FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC) FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE FINASTERIDE, FINASTERIDE FLUCONAZOLE, FLUCONAZOLE FLUOCINONIDE EMULSIFIED BASE, FLUOCINONIDE FLUOCINONIDE, FLUOCINONIDE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE FLURBIPROFEN, FLURBIPROFEN FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE FOSINOPRIL SODIUM, FOSINOPRIL SODIUM GALZIN, ZINC ACETATE GEMFIBROZIL, GEMFIBROZIL GLIMEPIRIDE, GLIMEPIRIDE GLYBURIDE (MICRONIZED), GLYBURIDE GLYBURIDE, GLYBURIDE HYDROCODONE BITARTRATE AND IBUPROFEN, HYDROCODONE BITARTRATE ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE KETOCONAZOLE, KETOCONAZOLE KETOPROFEN, KETOPROFEN KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE LAMOTRIGINE, LAMOTRIGINE LEVOFLOXACIN, LEVOFLOXACIN LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE LORATADINE, LORATADINE (OTC) LOSARTAN POTASSIUM, LOSARTAN POTASSIUM LOVASTATIN, LOVASTATIN MESALAMINE, MESALAMINE METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE METOLAZONE, METOLAZONE METOPROLOL TARTRATE, METOPROLOL TARTRATE METRONIDAZOLE, METRONIDAZOLE MEXILETINE HYDROCHLORIDE, MEXILETINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE MIRTAZAPINE, MIRTAZAPINE MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE MOEXIPRIL HYDROCHLORIDE, MOEXIPRIL HYDROCHLORIDE MUPIROCIN, MUPIROCIN NABUMETONE, NABUMETONE
NAPROXEN SODIUM, NAPROXEN SODIUM

NAPROXEN, NAPROXEN

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** T **

* TEVA PHARMACEUTICALS USA INC NEFAZODONE HYDROCHLORIDE, NEFAZODONE HYDROCHLORIDE NEOMYCIN SULFATE, NEOMYCIN SULFATE NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE NIZATIDINE, NIZATIDINE NORTRIPTYLINE HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE NYSTATIN, NYSTATIN OFLOXACIN, OFLOXACIN ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE ONDANSETRON, ONDANSETRON ORAP, PIMOZIDE OXAPROZIN, OXAPROZIN OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE PENICILLIN-VK, PENICILLIN V POTASSIUM PIROXICAM, PIROXICAM PRAVASTATIN SODIUM, PRAVASTATIN SODIUM PRELONE, PREDNISOLONE PURINETHOL, MERCAPTOPURINE QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE RIBAVIRIN, RIBAVIRIN RISPERIDONE, RISPERIDONE ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE SUCRALFATE, SUCRALFATE SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH, SULFAMETHOXAZOLE SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE TAMOXIFEN CITRATE, TAMOXIFEN CITRATE TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE TICLOPIDINE HYDROCHLORIDE, TICLOPIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE TOLMETIN SODIUM, TOLMETIN SODIUM TOPIRAMATE, TOPIRAMATE TORSEMIDE, TORSEMIDE TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE TRIACET, TRIAMCINOLONE ACETONIDE TRIMETHOPRIM, TRIMETHOPRIM
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
TEVA BRANDED PHARM * TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE * TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D INC
QVAR 40, BECLOMETHASONE DIPROPIONATE

QVAR 80, BECLOMETHASONE DIPROPIONATE
TEVA GLOBAL * TEVA GLOBAL RESPIRATORY RESEARCH LLC
PROAIR HFA, ALBUTEROL SULFATE
PROGLYCEM, DIAZOXIDE

TEVA PARENTERAL * TEVA PARENTERAL MEDICINES INC ADENOSINE, ADENOSINE ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE ALBUTEROL SULFATE, ALBUTEROL SULFATE ALPROSTADIL, ALPROSTADIL AMIKACIN SULFATE, AMIKACIN SULFATE AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE
AZITHROMYCIN, AZITHROMYCIN

BLEOMYCIN SULFATE, BLEOMYCIN SULFATE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** T **

* TEVA PARENTERAL MEDICINES INC BUDESONIDE, BUDESONIDE CALCITRIOL, CALCITRIOL CARBOPLATIN, CARBOPLATIN CEFTRIAXONE, CEFTRIAXONE SODIUM CIPROFLOXACIN, CIPROFLOXACIN CISPLATIN, CISPLATIN CROMOLYN SODIUM, CROMOLYN SODIUM CYTOSAR-U, CYTARABINE DACARBAZINE, DACARBAZINE DAUNORUBICIN HYDROCHLORIDE, DAUNORUBICIN HYDROCHLORIDE DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE DIPYRIDAMOLE, DIPYRIDAMOLE DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE ENALAPRILAT, ENALAPRILAT EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE EPOPROSTENOL SODIUM, EPOPROSTENOL SODIUM ETOPOSIDE, ETOPOSIDE FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE FLUMAZENIL, FLUMAZENIL FLUOROURACIL, FLUOROURACIL FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE, GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE HALOPERIDOL, HALOPERIDOL LACTATE IDARUBICIN HYDROCHLORIDE PFS, IDARUBICIN HYDROCHLORIDE IDARUBICIN HYDROCHLORIDE, IDARUBICIN HYDROCHLORIDE IFOSFAMIDE, IFOSFAMIDE IFOSFAMIDE/MESNA KIT, IFOSFAMIDE IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM LEUPROLIDE ACETATE, LEUPROLIDE ACETATE LEVOCARNITINE, LEVOCARNITINE MEDROXYPROGESTERONE ACETATE, MEDROXYPROGESTERONE ACETATE MESNA, MESNA METHYLDOPATE HYDROCHLORIDE, METHYLDOPATE HYDROCHLORIDE METHYLPREDNISOLONE ACETATE, METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE SODIUM SUCCINATE METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE OCTREOTIDE ACETATE, OCTREOTIDE ACETATE OXALIPLATIN, OXALIPLATIN OXYTOCIN, OXYTOCIN PACLITAXEL, PACLITAXEL PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM PANCURONIUM BROMIDE, PANCURONIUM BROMIDE PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE PROPOFOL, PROPOFOL ROCURONIUM BROMIDE, ROCURONIUM BROMIDE SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE TERBUTALINE SULFATE, TERBUTALINE SULFATE TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE VECURONIUM BROMIDE, VECURONIUM BROMIDE VINCRISTINE SULFATE PFS, VINCRISTINE SULFATE
VINORELBINE TARTRATE, VINORELBINE TARTRATE

ZANOSAR, STREPTOZOCIN

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** T **

TEVA PARNTL * TEVA PARENTAL MEDICINE INC DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE,

DORZOLAMIDE HYDROCHLORIDE

TEVA PHARMS * TEVA PHARMACEUTICALS USA ALENDRONATE SODIUM, ALENDRONATE SODIUM ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE ALPRAZOLAM, ALPRAZOLAM AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE ANASTROZOLE, ANASTROZOLE ATOMOXETINE HYDROCHLORIDE, ATOMOXETINE HYDROCHLORIDE AZITHROMYCIN, AZITHROMYCIN BISOPROLOL FUMARATE, BISOPROLOL FUMARATE CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE CEFDINIR, CEFDINIR CEFPROZIL, CEFPROZIL CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE CICLOPIROX, CICLOPIROX CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE ASPARTATE DIVALPROEX SODIUM, DIVALPROEX SODIUM DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE ETHOSUXIMIDE, ETHOSUXIMIDE FAMCICLOVIR, FAMCICLOVIR FENTANYL-100, FENTANYL FENTANYL-25, FENTANYL FENTANYL-50, FENTANYL FENTANYL-75, FENTANYL GABAPENTIN, GABAPENTIN GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE HALOPERIDOL, HALOPERIDOL LACTATE HYDROCORTISONE, HYDROCORTISONE HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE LAMIVUDINE AND ZIDOVUDINE, LAMIVUDINE LANSOPRAZOLE, LANSOPRAZOLE LEFLUNOMIDE, LEFLUNOMIDE LETROZOLE, LETROZOLE LEVETIRACETAM, LEVETIRACETAM LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE MEBENDAZOLE, MEBENDAZOLE MEGESTROL ACETATE, MEGESTROL ACETATE MELOXICAM, MELOXICAM METHAZOLAMIDE, METHAZOLAMIDE MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE NATEGLINIDE, NATEGLINIDE OLANZAPINE, OLANZAPINE ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER, ONDANSETRON HYDROCHLORIDE OXCARBAZEPINE, OXCARBAZEPINE PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE PRAVASTATIN SODIUM, PRAVASTATIN SODIUM PROCHLORPERAZINE MALEATE, PROCHLORPERAZINE MALEATE QUINIDINE SULFATE, QUINIDINE SULFATE RAMIPRIL, RAMIPRIL

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** T **

* TEVA PHARMACEUTICALS USA RISEDRONATE SODIUM, RISEDRONATE SODIUM TAMOXIFEN CITRATE, TAMOXIFEN CITRATE TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE TRANDOLAPRIL, TRANDOLAPRIL URSODIOL, URSODIOL VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE VALPROIC ACID, VALPROIC ACID VANDAZOLE, METRONIDAZOLE

ZALEPLON, ZALEPLON

TEVA PHARMS USA * TEVA PHARMACEUTICALS USA INC IMIQUIMOD, IMIQUIMOD TEVA WOMENS * TEVA WOMENS HEALTH INC CENESTIN, ESTROGENS, CONJUGATED SYNTHETIC A ENJUVIA, ESTROGENS, CONJUGATED SYNTHETIC B LOSEASONIQUE, ETHINYL ESTRADIOL MIRCETTE, DESOGESTREL PLAN B, LEVONORGESTREL PLAN B, LEVONORGESTREL (OTC) PREFEST, ESTRADIOL SEASONIQUE, ETHINYL ESTRADIOL
SYNTHETIC CONJUGATED ESTROGENS A, ESTROGENS, CONJUGATED SYNTHETIC A
THE PHARMA NETWORK * THE PHARMA NETWORK LLC BENZONATATE, BENZONATATE THE PHARMANETWORK * THE PHARMANETWORK LLC METHADONE HYDROCHLORIDE, THERAKOS * THERAKOS INC UVADEX, METHOXSALEN THERATECHNOLOGIES * THERATECHNOLOGIES INC EGRIFTA, TESAMORELIN ACETATE THERAVANCE INC * THERAVANCE INC VIBATIV, TELAVANCIN HYDROCHLORIDE THREE RIVERS PHARMS * THREE RIVERS PHARMACEUTICALS LLC ANASTROZOLE, ANASTROZOLE RIBASPHERE, RIBAVIRIN RIBAVIRIN, RIBAVIRIN

TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE

TIBOTEC * TIBOTEC INC EDURANT, RILPIVIRINE HYDROCHLORIDE INTELENCE, ETRAVIRINE

PREZISTA, DARUNAVIR ETHANOLATE

TOLMAR * TOLMAR INC ATRIDOX, DOXYCYCLINE HYCLATE BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE CALCIPOTRIENE, CALCIPOTRIENE CICLOPIROX, CICLOPIROX CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE ERYTHROMYCIN AND BENZOYL PEROXIDE, BENZOYL PEROXIDE
FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE

IMIQUIMOD, IMIQUIMOD

METHADONE HYDROCHLORIDE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** T **

* TOLMAR INC KETOCONAZOLE, KETOCONAZOLE LEVETIRACETAM, LEVETIRACETAM LIDOCAINE AND PRILOCAINE, LIDOCAINE METRONIDAZOLE, METRONIDAZOLE MOMETASONE FUROATE, MOMETASONE FUROATE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

TOLMAR THERAP * TOLMAR THERAPEUTICS INC ELIGARD, LEUPROLIDE ACETATE TOPOTARGET * TOPOTARGET AS TOTECT, DEXRAZOXANE HYDROCHLORIDE TORPHARM * TORPHARM INC RANITIDINE HYDROCHLORIDE, TORRENT PHARM * TORRENT PHARMA INC METFORMIN HYDROCHLORIDE,

RANITIDINE HYDROCHLORIDE

(OTC)

METFORMIN HYDROCHLORIDE

TORRENT PHARMS * TORRENT PHARMACEUTICALS LIMITED LEVOFLOXACIN, LEVOFLOXACIN * TORRENT PHARMACEUTICALS LTD AMLODIPINE BESYLATE, AMLODIPINE BESYLATE CARBAMAZEPINE, CARBAMAZEPINE CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE LAMOTRIGINE, LAMOTRIGINE LEVETIRACETAM, LEVETIRACETAM LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM, LOSARTAN POTASSIUM METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE RISPERIDONE, RISPERIDONE SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
TOPIRAMATE, TOPIRAMATE

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
* TORRENT PHARMACEUTICALS LTD. ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE TORRENT PHARMS LLC * TORRENT PHARMACEUTICALS LLC CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)
OLANZAPINE, OLANZAPINE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
TORRENT PHARMS LTD * TORRENT PHARMACEUTICALS LTD FELODIPINE, FELODIPINE TRIAX PHARMS LLC * TRIAX PHARMACEUTICALS LLC LOCOID LIPOCREAM, HYDROCORTISONE BUTYRATE LOCOID, HYDROCORTISONE BUTYRATE
MINOCIN, MINOCYCLINE HYDROCHLORIDE

TRETINOIN, TRETINOIN
TRIS PHARMA INC * TRIS PHARMA INC HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX,
IBUPROFEN, IBUPROFEN (OTC)

LEVETIRACETAM, LEVETIRACETAM

CHLORPHENIRAMINE POLISTIREX

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** T **
METHYLPHENIDATE HYDROCHLORIDE

* TRIS PHARMA INC METHYLPHENIDATE HYDROCHLORIDE,

UCB INC * UCB INC CO-GESIC, ACETAMINOPHEN KEPPRA XR, LEVETIRACETAM KEPPRA, LEVETIRACETAM LORTAB, ACETAMINOPHEN METADATE CD, METHYLPHENIDATE HYDROCHLORIDE METADATE ER, METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE MONOKET, ISOSORBIDE MONONITRATE PEDIAPRED, PREDNISOLONE SODIUM PHOSPHATE SEMPREX-D, ACRIVASTINE THEO-24, THEOPHYLLINE TUSSIONEX PENNKINETIC, CHLORPHENIRAMINE POLISTIREX UNIRETIC, HYDROCHLOROTHIAZIDE UNIVASC, MOEXIPRIL HYDROCHLORIDE VIMPAT, LACOSAMIDE XYZAL, LEVOCETIRIZINE DIHYDROCHLORIDE

ZAROXOLYN, METOLAZONE

UCYCLYD * UCYCLYD PHARMA INC AMMONUL, SODIUM BENZOATE UDL LABS * UDL LABORATORIES SULFAMYLON, MAFENIDE ACETATE ULURU * ULURU INC APHTHASOL,

AMLEXANOX

UNICHEM * UNICHEM LABORATORIES LTD BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE, BISOPROLOL FUMARATE CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC) CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE MELOXICAM, MELOXICAM
TOPIRAMATE, TOPIRAMATE
ZALEPLON, ZALEPLON

UNICHEM LABS LTD * UNICHEM LABORATORIES LIMITED DIVALPROEX SODIUM, DIVALPROEX SODIUM * UNICHEM LABORATORIES LTD LAMOTRIGINE, LAMOTRIGINE UNICHEM PHARMS (USA) * UNICHEM PHARMACEUTICALS (USA) INC BISOPROLOL FUMARATE, BISOPROLOL FUMARATE UNIQUE PHARM LABS * UNIQUE PHARMACEUTICAL LABORATORIES ATENOLOL, ATENOLOL CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC) CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE DICLOFENAC SODIUM, DICLOFENAC SODIUM

FLUCONAZOLE, FLUCONAZOLE

UNITED GUARDIAN * UNITED GUARDIAN INC RENACIDIN, CITRIC ACID

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** U **

UNITED THERAP * UNITED THERAPEUTICS CORP

REMODULIN, TREPROSTINIL SODIUM

TYVASO, TREPROSTINIL SODIUM
UPSHER SMITH * UPSHER SMITH LABORATORIES INC AMLODIPINE BESYLATE, AMLODIPINE BESYLATE BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE DIVALPROEX SODIUM, DIVALPROEX SODIUM DIVIGEL, ESTRADIOL FORTICAL, CALCITONIN SALMON RECOMBINANT KLOR-CON M10, POTASSIUM CHLORIDE KLOR-CON M15, POTASSIUM CHLORIDE KLOR-CON M20, POTASSIUM CHLORIDE LAMOTRIGINE, LAMOTRIGINE LOSARTAN POTASSIUM, LOSARTAN POTASSIUM NIACOR, NIACIN NYSTATIN, NYSTATIN ORVATEN, MIDODRINE HYDROCHLORIDE OXANDROLONE, OXANDROLONE PACERONE, AMIODARONE HYDROCHLORIDE PENTOXIL, PENTOXIFYLLINE PREVALITE, CHOLESTYRAMINE PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE SORINE, SOTALOL HYDROCHLORIDE
TOPIRAMATE, TOPIRAMATE

ZALEPLON, ZALEPLON
UPSHER-SMITH LABS * UPSHER-SMITH LABORATORIES INC KLOR-CON, POTASSIUM CHLORIDE US WORLDMEDS * US WORLDMEDS LLC
APOKYN, APOMORPHINE HYDROCHLORIDE

DANTROLENE SODIUM, DANTROLENE SODIUM
USL PHARMA * USL PHARMA INC AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE BACLOFEN, BACLOFEN BENZTROPINE MESYLATE, BENZTROPINE MESYLATE CHLORDIAZEPOXIDE HYDROCHLORIDE, CHLORDIAZEPOXIDE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE, CHLORPROMAZINE HYDROCHLORIDE ESTRADIOL, ESTRADIOL FLUOXYMESTERONE, FLUOXYMESTERONE JANTOVEN, WARFARIN SODIUM
MEDROXYPROGESTERONE ACETATE, MEDROXYPROGESTERONE ACETATE

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE
VALEANT * VALEANT PHARMACEUTICALS INTERNATIONAL ANCOBON, FLUCYTOSINE BONTRIL PDM, PHENDIMETRAZINE TARTRATE
BONTRIL, PHENDIMETRAZINE TARTRATE

CAPITAL AND CODEINE, ACETAMINOPHEN

D.H.E. 45, DIHYDROERGOTAMINE MESYLATE

DIASTAT ACUDIAL, DIAZEPAM

DIASTAT, DIAZEPAM

MIGRANAL, DIHYDROERGOTAMINE MESYLATE

MOTOFEN, ATROPINE SULFATE

MYSOLINE, PRIMIDONE

PHRENILIN FORTE, ACETAMINOPHEN

PHRENILIN WITH CAFFEINE AND CODEINE, ACETAMINOPHEN

PHRENILIN, ACETAMINOPHEN

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** V **

VALEANT INTL * VALEANT INTERNATIONAL BARBADOS SRL ATIVAN, LORAZEPAM CARDIZEM CD, DILTIAZEM HYDROCHLORIDE CARDIZEM LA, DILTIAZEM HYDROCHLORIDE CARDIZEM, DILTIAZEM HYDROCHLORIDE DICLOFENAC SODIUM, DICLOFENAC SODIUM DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE ELIDEL, PIMECROLIMUS ISORDIL, ISOSORBIDE DINITRATE NIFEDIPINE, NIFEDIPINE PENTOXIFYLLINE, PENTOXIFYLLINE TIAZAC, DILTIAZEM HYDROCHLORIDE ULTRAM ER, TRAMADOL HYDROCHLORIDE VASERETIC, ENALAPRIL MALEATE VASOTEC, ENALAPRIL MALEATE VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE WELLBUTRIN XL, BUPROPION HYDROCHLORIDE
XERESE, ACYCLOVIR

ZOVIRAX, ACYCLOVIR
* VALEANT INTERNATIONAL SRL APLENZIN, BUPROPION HYDROBROMIDE
RETIN-A MICRO, TRETINOIN

XENAZINE, TETRABENAZINE
VALEANT PHARM INTL * VALEANT PHARMACEUTICALS INTERNATIONAL 8-MOP, METHOXSALEN ANDROID 10, METHYLTESTOSTERONE ANDROID 25, METHYLTESTOSTERONE EFUDEX, FLUOROURACIL LIBRIUM, CHLORDIAZEPOXIDE HYDROCHLORIDE LIMBITROL DS, AMITRIPTYLINE HYDROCHLORIDE LIMBITROL, AMITRIPTYLINE HYDROCHLORIDE MESTINON, PYRIDOSTIGMINE BROMIDE OXSORALEN, METHOXSALEN OXSORALEN-ULTRA, METHOXSALEN TASMAR, TOLCAPONE TENSILON PRESERVATIVE FREE, EDROPHONIUM CHLORIDE TENSILON, EDROPHONIUM CHLORIDE TESTRED, METHYLTESTOSTERONE
VIRAZOLE, RIBAVIRIN

ZELAPAR, SELEGILINE HYDROCHLORIDE
VALEANT PHARMS * VALEANT PHARMACEUTICALS NORTH AMERICA POTIGA, EZOGABINE VALIDUS PHARMS * VALIDUS PHARMACEUTICALS LLC ROCALTROL, CALCITRIOL VALIDUS PHARMS INC * VALIDUS PHARMACEUTICALS INC
EQUETRO, CARBAMAZEPINE

MARPLAN, ISOCARBOXAZID
VEROSCIENCE * VEROSCIENCE LLC CYCLOSET, BROMOCRIPTINE MESYLATE VERSAPHARM * VERSAPHARM INC CICLOPIROX, CICLOPIROX CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE
DEMECLOCYCLINE HYDROCHLORIDE, DEMECLOCYCLINE HYDROCHLORIDE

DESOXIMETASONE, DESOXIMETASONE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** V **

* VERSAPHARM INC ERYTHROMYCIN, ERYTHROMYCIN ETHOSUXIMIDE, ETHOSUXIMIDE

RIFAMPIN, RIFAMPIN

VERSAPHARM INC * VERSAPHARM INC RIFAMPIN, RIFAMPIN * VERSAPHARM INCORPORATED TRANEXAMIC ACID, TRANEXAMIC ACID VERTEX PHARMS * VERTEX PHARMACEUTICALS INC INCIVEK, TELAPREVIR VICURON * VICURON PHARMACEUTICALS INC ERAXIS, ANIDULAFUNGIN VIIV HLTHCARE * VIIV HEALTHCARE CO COMBIVIR, LAMIVUDINE EPIVIR, LAMIVUDINE EPZICOM, ABACAVIR SULFATE LEXIVA, FOSAMPRENAVIR CALCIUM RESCRIPTOR, DELAVIRDINE MESYLATE RETROVIR, ZIDOVUDINE SELZENTRY, MARAVIROC TRIZIVIR, ABACAVIR SULFATE

ZIAGEN, ABACAVIR SULFATE

VINTAGE * VINTAGE PHARMACEUTICALS LLC ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN ACETIC ACID, ACETIC ACID, GLACIAL ALBUTEROL SULFATE, ALBUTEROL SULFATE ALPRAZOLAM, ALPRAZOLAM AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE AMLODIPINE BESYLATE, AMLODIPINE BESYLATE BENZTROPINE MESYLATE, BENZTROPINE MESYLATE CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE CYCLAFEM 1/35, ETHINYL ESTRADIOL CYCLAFEM 7/7/7, ETHINYL ESTRADIOL DIVALPROEX SODIUM, DIVALPROEX SODIUM EMOQUETTE, DESOGESTREL FOLIC ACID, FOLIC ACID GILDESS FE 1.5/30, ETHINYL ESTRADIOL GILDESS FE 1/20, ETHINYL ESTRADIOL GLIMEPIRIDE, GLIMEPIRIDE GLYCOPYRROLATE, GLYCOPYRROLATE GRISEOFULVIN, GRISEOFULVIN HYDROCORTISONE AND ACETIC ACID, ACETIC ACID, GLACIAL HYDROCORTISONE, HYDROCORTISONE LIDOCAINE HYDROCHLORIDE VISCOUS, LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE LISINOPRIL, LISINOPRIL NYSTATIN, NYSTATIN PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE, PREDNISOLONE PREVIFEM, ETHINYL ESTRADIOL PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE, CODEINE PHOSPHATE PROMETHAZINE DM, DEXTROMETHORPHAN HYDROBROMIDE PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE WITH CODEINE, CODEINE PHOSPHATE

RISPERIDONE, RISPERIDONE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** V **

* VINTAGE PHARMACEUTICALS LLC SPIRONOLACTONE, SPIRONOLACTONE SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE TRI-PREVIFEM, ETHINYL ESTRADIOL VALPROIC ACID, VALPROIC ACID VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

VINTAGE PHARMS * VINTAGE PHARMACEUTICALS LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL ORSYTHIA, ETHINYL ESTRADIOL

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

* VINTAGE PHARMACEUTICALS INC ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN ALLOPURINOL, ALLOPURINOL AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE BACLOFEN, BACLOFEN BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE, ACETAMINOPHEN CARISOPRODOL, CARISOPRODOL CLONAZEPAM, CLONAZEPAM CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE DEXAMETHASONE, DEXAMETHASONE DIAZEPAM, DIAZEPAM DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE FUROSEMIDE, FUROSEMIDE HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN HYDROCODONE BITARTRATE AND IBUPROFEN, HYDROCODONE BITARTRATE HYDROCORTISONE, HYDROCORTISONE HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE IBUPROFEN, IBUPROFEN IBUPROFEN, IBUPROFEN (OTC) ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE LACTULOSE, LACTULOSE LEVETIRACETAM, LEVETIRACETAM LORAZEPAM, LORAZEPAM MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE METHOCARBAMOL, METHOCARBAMOL METHYLPREDNISOLONE, METHYLPREDNISOLONE METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE NYSTATIN, NYSTATIN OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE PERPHENAZINE, PERPHENAZINE PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE PREDNISONE, PREDNISONE PRIMIDONE, PRIMIDONE PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE SULFASALAZINE, SULFASALAZINE
TORSEMIDE, TORSEMIDE

TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE
VIROPHARMA * VIROPHARMA INC VANCOCIN HYDROCHLORIDE,

VANCOMYCIN HYDROCHLORIDE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** V **

VISTA PHARMS * VISTA PHARMACEUTICALS INC SULFAMETHOXAZOLE AND TRIMETHOPRIM,

SULFAMETHOXAZOLE

VISTAPHARM * VISTAPHARM INC ALBUTEROL SULFATE, ALBUTEROL SULFATE LACTULOSE, LACTULOSE METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE MORPHINE SULFATE, MORPHINE SULFATE
NYSTATIN, NYSTATIN

PHENYTOIN, PHENYTOIN
WARNER CHILCOTT * WARNER CHILCOTT BERMUDA LTD CHOLEDYL SA, OXTRIPHYLLINE * WARNER CHILCOTT CO LLC
ACTONEL, RISEDRONATE SODIUM

ATELVIA, RISEDRONATE SODIUM
* WARNER CHILCOTT INC ERYC, ERYTHROMYCIN ESTRACE, ESTRADIOL ESTROSTEP FE, ETHINYL ESTRADIOL FEMCON FE, ETHINYL ESTRADIOL FEMHRT, ETHINYL ESTRADIOL FEMTRACE, ESTRADIOL ACETATE LOESTRIN 21 1.5/30, ETHINYL ESTRADIOL LOESTRIN 21 1/20, ETHINYL ESTRADIOL LOESTRIN 24 FE, ETHINYL ESTRADIOL LOESTRIN FE 1.5/30, ETHINYL ESTRADIOL LOESTRIN FE 1/20, ETHINYL ESTRADIOL OVCON-35, ETHINYL ESTRADIOL
OVCON-50, ETHINYL ESTRADIOL

SARAFEM, FLUOXETINE HYDROCHLORIDE
WARNER CHILCOTT CO * WARNER CHILCOTT CO INC LO LOESTRIN FE, ETHINYL ESTRADIOL WARNER CHILCOTT LLC * WARNER CHILCOTT CO LLC ASACOL HD, MESALAMINE
ASACOL, MESALAMINE

ENABLEX, DARIFENACIN HYDROBROMIDE
WATSON LABS * WATSON LABORATORIES ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE, ACETAMINOPHEN ALENDRONATE SODIUM, ALENDRONATE SODIUM ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE ANASTROZOLE, ANASTROZOLE CARBOPLATIN, CARBOPLATIN CARVEDILOL, CARVEDILOL FOLIC ACID, FOLIC ACID LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE MICROGESTIN 1.5/30, ETHINYL ESTRADIOL MICROGESTIN 1/20, ETHINYL ESTRADIOL MICROGESTIN FE 1.5/30, ETHINYL ESTRADIOL MICROGESTIN FE 1/20, ETHINYL ESTRADIOL NORCO, ACETAMINOPHEN NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL OXAPROZIN, OXAPROZIN OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN
PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** W **

* WATSON LABORATORIES INC ACARBOSE, ACARBOSE ACEBUTOLOL HYDROCHLORIDE, ACEBUTOLOL HYDROCHLORIDE ACETAZOLAMIDE, ACETAZOLAMIDE ACETOHEXAMIDE, ACETOHEXAMIDE ACYCLOVIR, ACYCLOVIR AFEDITAB CR, NIFEDIPINE ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE ALBUTEROL SULFATE, ALBUTEROL SULFATE ALENDRONATE SODIUM, ALENDRONATE SODIUM ALLOPURINOL, ALLOPURINOL ALORA, ESTRADIOL AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE AMLODIPINE BESYLATE, AMLODIPINE BESYLATE AMOXAPINE, AMOXAPINE ANDRODERM, TESTOSTERONE ATENOLOL AND CHLORTHALIDONE, ATENOLOL ATENOLOL, ATENOLOL BACLOFEN, BACLOFEN BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE, BISOPROLOL FUMARATE BREVICON 28-DAY, ETHINYL ESTRADIOL BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE, ASPIRIN CABERGOLINE, CABERGOLINE CAPTOPRIL, CAPTOPRIL CARBOPLATIN, CARBOPLATIN CARISOPRODOL, CARISOPRODOL CHLORDIAZEPOXIDE HYDROCHLORIDE, CHLORDIAZEPOXIDE HYDROCHLORIDE CHLORPROPAMIDE, CHLORPROPAMIDE CHLORZOXAZONE, CHLORZOXAZONE CICLOPIROX, CICLOPIROX CIMETIDINE, CIMETIDINE CIMETIDINE, CIMETIDINE (OTC) CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE CLONAZEPAM, CLONAZEPAM CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE CLORAZEPATE DIPOTASSIUM, CLORAZEPATE DIPOTASSIUM COL-PROBENECID, COLCHICINE CORDRAN, FLURANDRENOLIDE CRINONE, PROGESTERONE CROMOLYN SODIUM, CROMOLYN SODIUM CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE CYCLOSPORINE, CYCLOSPORINE DEFEROXAMINE MESYLATE, DEFEROXAMINE MESYLATE DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE DESOGESTREL AND ETHINYL ESTRADIOL, DESOGESTREL DIAZEPAM, DIAZEPAM DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE DILACOR XR, DILTIAZEM HYDROCHLORIDE DIMENHYDRINATE, DIMENHYDRINATE DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE, DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE DIPYRIDAMOLE, DIPYRIDAMOLE DISOPYRAMIDE PHOSPHATE, DISOPYRAMIDE PHOSPHATE DOBUTAMINE HYDROCHLORIDE, DOBUTAMINE HYDROCHLORIDE DOXAPRAM HYDROCHLORIDE, DOXAPRAM HYDROCHLORIDE DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

DOXYCYCLINE, DOXYCYCLINE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** W **

* WATSON LABORATORIES INC DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE ENALAPRIL MALEATE, ENALAPRIL MALEATE EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE ERGOLOID MESYLATES, ERGOLOID MESYLATES ESTAZOLAM, ESTAZOLAM ESTRADIOL CYPIONATE, ESTRADIOL CYPIONATE ESTRADIOL VALERATE, ESTRADIOL VALERATE ESTRADIOL, ESTRADIOL ESTRONE, ESTRONE ESTROPIPATE, ESTROPIPATE FAMCICLOVIR, FAMCICLOVIR FAMOTIDINE, FAMOTIDINE FAMOTIDINE, FAMOTIDINE (OTC) FENTANYL CITRATE, FENTANYL CITRATE FENTANYL-100, FENTANYL FENTANYL-25, FENTANYL FENTANYL-50, FENTANYL FENTANYL-75, FENTANYL FLURAZEPAM HYDROCHLORIDE, FLURAZEPAM HYDROCHLORIDE FLUTAMIDE, FLUTAMIDE FOSINOPRIL SODIUM, FOSINOPRIL SODIUM FUROSEMIDE, FUROSEMIDE GABAPENTIN, GABAPENTIN GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE GELNIQUE, OXYBUTYNIN CHLORIDE GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE GEMFIBROZIL, GEMFIBROZIL GLIMEPIRIDE, GLIMEPIRIDE GLIPIZIDE, GLIPIZIDE GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN HYDROXOCOBALAMIN, HYDROXOCOBALAMIN HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE HYDROXYZINE PAMOATE, HYDROXYZINE PAMOATE IBUPROFEN, IBUPROFEN IBUPROFEN, IBUPROFEN (OTC) INDAPAMIDE, INDAPAMIDE IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE ISONIAZID, ISONIAZID ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE ISRADIPINE, ISRADIPINE LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE LAMOTRIGINE, LAMOTRIGINE LEVETIRACETAM, LEVETIRACETAM LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL LEVONORGESTREL, LEVONORGESTREL LEVONORGESTREL, LEVONORGESTREL (OTC) LEVORA 0.15/30-28, ETHINYL ESTRADIOL LISINOPRIL, LISINOPRIL LORAZEPAM, LORAZEPAM LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM, LOSARTAN POTASSIUM LOW-OGESTREL-21, ETHINYL ESTRADIOL LOW-OGESTREL-28, ETHINYL ESTRADIOL LOXAPINE SUCCINATE, LOXAPINE SUCCINATE
MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE

MECLOFENAMATE SODIUM, MECLOFENAMATE SODIUM

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** W **

* WATSON LABORATORIES INC MELOXICAM, MELOXICAM MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE, MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE MEPIVACAINE HYDROCHLORIDE, MEPIVACAINE HYDROCHLORIDE MEPROBAMATE, MEPROBAMATE METAPROTERENOL SULFATE, METAPROTERENOL SULFATE METHOCARBAMOL, METHOCARBAMOL METHYCLOTHIAZIDE, METHYCLOTHIAZIDE METHYLDOPA, METHYLDOPA METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE METHYLPREDNISOLONE, METHYLPREDNISOLONE METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE METOPROLOL TARTRATE, METOPROLOL TARTRATE METRONIDAZOLE, METRONIDAZOLE MEXILETINE HYDROCHLORIDE, MEXILETINE HYDROCHLORIDE MICROZIDE, HYDROCHLOROTHIAZIDE MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE MINOXIDIL, MINOXIDIL MIRTAZAPINE, MIRTAZAPINE MORPHINE SULFATE, MORPHINE SULFATE NABUMETONE, NABUMETONE NAPROXEN SODIUM, NAPROXEN SODIUM NAPROXEN, NAPROXEN NATEGLINIDE, NATEGLINIDE NEOMYCIN AND POLYMYXIN B SULFATE, NEOMYCIN SULFATE NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE NICOTINE POLACRILEX, NICOTINE POLACRILEX (OTC) NITROFURANTOIN, NITROFURANTOIN, MACROCRYSTALLINE NIZATIDINE, NIZATIDINE NORCO, ACETAMINOPHEN NORETHIN 1/35E-21, ETHINYL ESTRADIOL NORETHIN 1/35E-28, ETHINYL ESTRADIOL NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL NORETHINDRONE AND ETHINYL ESTRADIOL (10/11), ETHINYL ESTRADIOL NORETHINDRONE AND ETHINYL ESTRADIOL (7/14), ETHINYL ESTRADIOL NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL NORETHINDRONE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL NORGESTIMATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL NORINYL 1+35 21-DAY, ETHINYL ESTRADIOL NORINYL 1+35 28-DAY, ETHINYL ESTRADIOL NORINYL 1+50 28-DAY, MESTRANOL NORTRIPTYLINE HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE OGESTREL 0.5/50-28, ETHINYL ESTRADIOL ORPHENADRINE CITRATE, ORPHENADRINE CITRATE OXAZEPAM, OXAZEPAM OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN OXYCODONE AND ASPIRIN, ASPIRIN OXYCODONE HYDROCHLORIDE AND IBUPROFEN, IBUPROFEN PENTAMIDINE ISETHIONATE, PENTAMIDINE ISETHIONATE PENTAZOCINE AND NALOXONE HYDROCHLORIDES, NALOXONE HYDROCHLORIDE PENTOXIFYLLINE, PENTOXIFYLLINE PINDOLOL, PINDOLOL PIROXICAM, PIROXICAM PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE PRAVASTATIN SODIUM, PRAVASTATIN SODIUM PREDNISOLONE, PREDNISOLONE PREDNISONE, PREDNISONE PRIMIDONE, PRIMIDONE PROBENECID, PROBENECID PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

QUASENSE, ETHINYL ESTRADIOL

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** W **

* WATSON LABORATORIES INC QUINIDINE GLUCONATE, QUINIDINE GLUCONATE QUINIDINE SULFATE, QUINIDINE SULFATE RAMIPRIL, RAMIPRIL RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC) RAPAFLO, SILODOSIN RISPERIDONE, RISPERIDONE RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE SIMVASTATIN, SIMVASTATIN SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE SULFASALAZINE, SULFASALAZINE SULINDAC, SULINDAC SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE TACROLIMUS, TACROLIMUS TAMOXIFEN CITRATE, TAMOXIFEN CITRATE TEMAZEPAM, TEMAZEPAM TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE TESTOSTERONE ENANTHATE, TESTOSTERONE ENANTHATE TETRACYCLINE HYDROCHLORIDE, TETRACYCLINE HYDROCHLORIDE THIAMINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE THIOTHIXENE, THIOTHIXENE TOLAZAMIDE, TOLAZAMIDE TOLBUTAMIDE, TOLBUTAMIDE TOPIRAMATE, TOPIRAMATE TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN TRANDOLAPRIL, TRANDOLAPRIL TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE TRELSTAR, TRIPTORELIN PAMOATE TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE TRIAZOLAM, TRIAZOLAM TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE TRIMETHOPRIM, TRIMETHOPRIM TRI-NORINYL 28-DAY, ETHINYL ESTRADIOL TRIVORA-28, ETHINYL ESTRADIOL VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE VECURONIUM BROMIDE, VECURONIUM BROMIDE VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
ZOVIA 1/35E-28, ETHINYL ESTRADIOL

ZOVIA 1/50E-28, ETHINYL ESTRADIOL
* WATSON LABS INC LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE WATSON LABS (UTAH) * WATSON LABORATORIES INC INFED, IRON DEXTRAN NOR-QD, NORETHINDRONE
OXYTROL, OXYBUTYNIN

PROGESTERONE, PROGESTERONE
WATSON LABS FLORIDA * WATSON LABORATORIES INC FLORIDA ALPRAZOLAM, ALPRAZOLAM BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE CARTIA XT, DILTIAZEM HYDROCHLORIDE CIPROFLOXACIN EXTENDED RELEASE, CIPROFLOXACIN CLARITHROMYCIN, CLARITHROMYCIN DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE DIVALPROEX SODIUM, DIVALPROEX SODIUM

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** W **

* WATSON LABORATORIES INC FLORIDA FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM FOSINOPRIL SODIUM, FOSINOPRIL SODIUM GLIMEPIRIDE, GLIMEPIRIDE HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN HYDROCODONE BITARTRATE AND IBUPROFEN, HYDROCODONE BITARTRATE KETOPROFEN, KETOPROFEN LEVETIRACETAM, LEVETIRACETAM LORATADINE AND PSEUDOEPHEDRINE SULFATE, LORATADINE (OTC) LORATADINE, LORATADINE (OTC) METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE METOPROLOL SUCCINATE, METOPROLOL SUCCINATE MIRTAZAPINE, MIRTAZAPINE OMEPRAZOLE, OMEPRAZOLE POTASSIUM CHLORIDE, POTASSIUM CHLORIDE QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE RISPERIDONE, RISPERIDONE TAMOXIFEN CITRATE, TAMOXIFEN CITRATE

TAZTIA XT, DILTIAZEM HYDROCHLORIDE

WATSON LABS INC * WATSON LABORATORIES INC ALBUTEROL SULFATE, ALBUTEROL SULFATE AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE FIORICET W/ CODEINE, ACETAMINOPHEN FIORINAL W/CODEINE, ASPIRIN FIORINAL, ASPIRIN LEVALBUTEROL HYDROCHLORIDE, LEVALBUTEROL HYDROCHLORIDE METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL URSODIOL, URSODIOL WATSON PHARMS * WATSON PHARMACEUTICALS
TENUATE DOSPAN, DIETHYLPROPION HYDROCHLORIDE

TENUATE, DIETHYLPROPION HYDROCHLORIDE
* WATSON PHARMACEUTICALS INC ACTIGALL, URSODIOL CONDYLOX, PODOFILOX CORDRAN SP, FLURANDRENOLIDE CORDRAN, FLURANDRENOLIDE
FIORICET, ACETAMINOPHEN

MONODOX, DOXYCYCLINE
WE PHARMS * WE PHARMACEUTICALS INC PREDNISOLONE SODIUM PHOSPHATE,

PREDNISOLONE SODIUM PHOSPHATE

WEILL MEDCL COLL * WEILL MEDICAL COLLEGE CORNELL UNIV FLUDEOXYGLUCOSE F 18, FLUDEOXYGLUCOSE F-18 WELLSPRING PHARM * WELLSPRING PHARMACEUTICAL CORP DIBENZYLINE, PHENOXYBENZAMINE HYDROCHLORIDE
DUVOID, BETHANECHOL CHLORIDE
DYRENIUM, TRIAMTERENE

WEST WARD * WEST WARD INC ERGOTAMINE TARTRATE AND CAFFEINE, CAFFEINE

ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE

* WEST WARD PHARMACEUTICAL CORP AMINOPHYLLINE, AMINOPHYLLINE BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE,
BUTALBITAL, ASPIRIN AND CAFFEINE, ASPIRIN

CAPTOPRIL, CAPTOPRIL

ACETAMINOPHEN

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** W **

* WEST WARD PHARMACEUTICAL CORP CARISOPRODOL, CARISOPRODOL CHLOROQUINE PHOSPHATE, CHLOROQUINE PHOSPHATE CHLOROTHIAZIDE, CHLOROTHIAZIDE CORTISONE ACETATE, CORTISONE ACETATE DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE DIGOXIN, DIGOXIN DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE ETHAMBUTOL HYDROCHLORIDE, ETHAMBUTOL HYDROCHLORIDE FLURAZEPAM HYDROCHLORIDE, FLURAZEPAM HYDROCHLORIDE FOLIC ACID, FOLIC ACID GLYCOPYRROLATE, GLYCOPYRROLATE HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE HYDROCORTISONE, HYDROCORTISONE HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE ISONIAZID, ISONIAZID ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LISINOPRIL, LISINOPRIL LITHIUM CARBONATE, LITHIUM CARBONATE MEFLOQUINE HYDROCHLORIDE, MEFLOQUINE HYDROCHLORIDE METHOCARBAMOL, METHOCARBAMOL ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE PREDNISONE, PREDNISONE PRIMIDONE, PRIMIDONE PROPYLTHIOURACIL, PROPYLTHIOURACIL TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE
ZALEPLON, ZALEPLON
WEST WARD PHARM CORP * WEST WARD PHARMACEUTICAL CORP PREDNISONE, PREDNISONE WEST WARD PHARMS * WEST WARD PHARMACEUTICALS CORP RISPERIDONE, RISPERIDONE WESTWARD * WESTWARD PHARMACEUTICAL CORP NAPROXEN, NAPROXEN

RIFAMPIN AND ISONIAZID, ISONIAZID

WEST-WARD PHARM CORP * WEST-WARD PHARMACEUTICAL CORP CEFOTETAN, CEFOTETAN DISODIUM DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

FLUDROCORTISONE ACETATE, FLUDROCORTISONE ACETATE

WOCKHARDT * WOCKHARDT AMERICAS INC CAPTOPRIL, CAPTOPRIL FAMOTIDINE, FAMOTIDINE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

* WOCKHARDT EU OPERATIONS (SWISS) AG ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN ACETIC ACID, ACETIC ACID, GLACIAL ALBUTEROL SULFATE, ALBUTEROL SULFATE AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN AMOXICILLIN, AMOXICILLIN BROMFED-DM, BROMPHENIRAMINE MALEATE CARBAMAZEPINE, CARBAMAZEPINE CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE CLEMASTINE FUMARATE, CLEMASTINE FUMARATE

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** W **

* WOCKHARDT EU OPERATIONS (SWISS) AG CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE CROMOLYN SODIUM, CROMOLYN SODIUM CYCLOSPORINE, CYCLOSPORINE DEXAMETHASONE, DEXAMETHASONE DEXCHLORPHENIRAMINE MALEATE, DEXCHLORPHENIRAMINE MALEATE DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE ERYTHROMYCIN, ERYTHROMYCIN FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE FUROSEMIDE, FUROSEMIDE HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE, HOMATROPINE METHYLBROMIDE HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE LEVETIRACETAM, LEVETIRACETAM LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE LINDANE, LINDANE LITHIUM CITRATE, LITHIUM CITRATE LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC) LORATADINE, LORATADINE (OTC) MEGESTROL ACETATE, MEGESTROL ACETATE METAPROTERENOL SULFATE, METAPROTERENOL SULFATE METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE MINOXIDIL (FOR MEN), MINOXIDIL (OTC) MINOXIDIL EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC) NYSTATIN, NYSTATIN OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE PHENYTOIN, PHENYTOIN PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE, PREDNISOLONE PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE PROMETHAZINE PLAIN, PROMETHAZINE HYDROCHLORIDE PROMETHAZINE W/ DEXTROMETHORPHAN, DEXTROMETHORPHAN HYDROBROMIDE SELENIUM SULFIDE, SELENIUM SULFIDE TRETINOIN, TRETINOIN
TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

VALPROIC ACID, VALPROIC ACID
* WOCKHARDT LTD ADENOSINE, ADENOSINE AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE AMLODIPINE BESYLATE, AMLODIPINE BESYLATE AZITHROMYCIN, AZITHROMYCIN BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE CARVEDILOL, CARVEDILOL CEFOTAXIME SODIUM, CEFOTAXIME SODIUM CEFOTAXIME, CEFOTAXIME SODIUM CEFPROZIL, CEFPROZIL CEFTAZIDIME, CEFTAZIDIME CEFTRIAXONE, CEFTRIAXONE SODIUM CEFUROXIME AXETIL, CEFUROXIME AXETIL CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE CLARITHROMYCIN, CLARITHROMYCIN DIVALPROEX SODIUM, DIVALPROEX SODIUM DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM FAMOTIDINE, FAMOTIDINE (OTC) FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM FUROSEMIDE, FUROSEMIDE KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE LEVETIRACETAM, LEVETIRACETAM
LEVOFLOXACIN, LEVOFLOXACIN

LISINOPRIL, LISINOPRIL

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

B - 148

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** W **

* WOCKHARDT LTD METOPROLOL SUCCINATE, METOPROLOL SUCCINATE MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE NIACIN, NIACIN NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC) RISPERIDONE, RISPERIDONE ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE TIMOLOL MALEATE, TIMOLOL MALEATE VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

ZONISAMIDE, ZONISAMIDE

WOCKHARDT USA * WOCKHARDT USA INC EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE OCTREOTIDE ACETATE (PRESERVATIVE FREE), OCTREOTIDE ACETATE

OCTREOTIDE ACETATE, OCTREOTIDE ACETATE

* WOCKHARDT USA LLC ENALAPRIL MALEATE, ENALAPRIL MALEATE

TOPIRAMATE, TOPIRAMATE

WORLD GEN * WORLD GEN LLC AMLODIPINE BESYLATE,

AMLODIPINE BESYLATE

WRASER PHARMS * WRASER PHARMACEUTICALS LLC CETRAXAL, CIPROFLOXACIN HYDROCHLORIDE WRASER PHARMS LLC * WRASER PHARMACEUTICALS LLC ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE, WYETH CONS * WYETH CONSUMER HEALTHCARE ADVIL ALLERGY SINUS, CHLORPHENIRAMINE MALEATE (OTC) ADVIL COLD AND SINUS, IBUPROFEN (OTC) ADVIL CONGESTION RELIEF, IBUPROFEN (OTC) ADVIL LIQUI-GELS, IBUPROFEN (OTC) ADVIL MIGRAINE LIQUI-GELS, IBUPROFEN (OTC) ADVIL PM, DIPHENHYDRAMINE HYDROCHLORIDE (OTC) ADVIL, IBUPROFEN (OTC) ALAVERT, LORATADINE (OTC) AXID AR, NIZATIDINE (OTC) CHILDREN'S ADVIL ALLERGY SINUS, CHLORPHENIRAMINE MALEATE CHILDREN'S ADVIL COLD, IBUPROFEN (OTC) CHILDREN'S ADVIL, IBUPROFEN (OTC) CHILDREN'S ADVIL-FLAVORED, IBUPROFEN (OTC) JUNIOR STRENGTH ADVIL, IBUPROFEN (OTC)
LORATADINE, LORATADINE (OTC)

PEDIATRIC ADVIL, IBUPROFEN (OTC)
WYETH PHARMS * WYETH PHARMACEUTICALS INC SUB PFIZER INC LO/OVRAL-28, ETHINYL ESTRADIOL

ACETAMINOPHEN

(OTC)

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

B - 149

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** W **

WYETH PHARMS INC * WYETH PHARMACEUTICALS INC CORDARONE, AMIODARONE HYDROCHLORIDE EFFEXOR XR, VENLAFAXINE HYDROCHLORIDE LYBREL, ETHINYL ESTRADIOL PHOSPHOLINE IODIDE, ECHOTHIOPHATE IODIDE PREMARIN, ESTROGENS, CONJUGATED PREMPHASE 14/14, ESTROGENS, CONJUGATED PREMPRO, ESTROGENS, CONJUGATED PRISTIQ, DESVENLAFAXINE SUCCINATE PROTONIX IV, PANTOPRAZOLE SODIUM PROTONIX, PANTOPRAZOLE SODIUM RAPAMUNE, SIROLIMUS TORISEL, TEMSIROLIMUS TRECATOR, ETHIONAMIDE TYGACIL, TIGECYCLINE
ZOSYN IN PLASTIC CONTAINER, PIPERACILLIN SODIUM

ZOSYN, PIPERACILLIN SODIUM
X GEN PHARMS * X GEN PHARMACEUTICALS INC ACETAZOLAMIDE SODIUM, ACETAZOLAMIDE SODIUM AMPHOTERICIN B, AMPHOTERICIN B BACIIM, BACITRACIN BACI-RX, BACITRACIN COLISTIMETHATE SODIUM, COLISTIMETHATE SODIUM EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE HYDROCORTISONE ACETATE, HYDROCORTISONE ACETATE HYDRO-RX, HYDROCORTISONE LIOTHYRONINE SODIUM, LIOTHYRONINE SODIUM NEO-FRADIN, NEOMYCIN SULFATE NEOMYCIN AND POLYMYXIN B SULFATE, NEOMYCIN SULFATE NEOMYCIN SULFATE, NEOMYCIN SULFATE NEO-RX, NEOMYCIN SULFATE NYSTATIN, NYSTATIN POLYMYXIN B SULFATE, POLYMYXIN B SULFATE POLY-RX, POLYMYXIN B SULFATE
STREPTOMYCIN SULFATE, STREPTOMYCIN SULFATE

TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE
XANODYNE PHARM * XANODYNE PHARMACEUTICS INC AMICAR, AMINOCAPROIC ACID
ORAMORPH SR, MORPHINE SULFATE

ZIPSOR, DICLOFENAC POTASSIUM
XANODYNE PHARMS * XANODYNE PHARMACEUTICALS INC ROXICODONE, OXYCODONE HYDROCHLORIDE X-GEN PHARMS * X-GEN PHARMACEUTICALS INC IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
PHENYTOIN SODIUM, PHENYTOIN SODIUM

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
XTTRIUM * XTTRIUM LABORATORIES INC CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE
DYNA-HEX, CHLORHEXIDINE GLUCONATE (OTC)

EXIDINE, CHLORHEXIDINE GLUCONATE (OTC)
YUNG SHIN PHARM * YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTD
CEFACLOR, CEFACLOR

CEPHALEXIN, CEPHALEXIN

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

B - 150

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** Z **

ZAMBON SPA * ZAMBON SPA ITALY MONUROL, FOSFOMYCIN TROMETHAMINE ZARS PHARM * ZARS PHARMA INC SYNERA, LIDOCAINE ZOGENIX INC * ZOGENIX INC SUMAVEL DOSEPRO,

SUMATRIPTAN SUCCINATE

ZYDUS PHARMS USA * ZYDUS PHARMACEUTICALS USA INC AMLODIPINE BESYLATE, AMLODIPINE BESYLATE ATENOLOL, ATENOLOL AZATHIOPRINE, AZATHIOPRINE BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE BENZONATATE, BENZONATATE CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE HALOPERIDOL, HALOPERIDOL HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE LAMOTRIGINE, LAMOTRIGINE MELOXICAM, MELOXICAM METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE NAPROXEN, NAPROXEN PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE PRAVASTATIN SODIUM, PRAVASTATIN SODIUM PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE RAMIPRIL, RAMIPRIL RIBAVIRIN, RIBAVIRIN RISPERIDONE, RISPERIDONE SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE SIMVASTATIN, SIMVASTATIN VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
WARFARIN SODIUM, WARFARIN SODIUM

ZONISAMIDE, ZONISAMIDE
ZYDUS PHARMS USA INC * ZYDUS PHARMACEUTICALS USA INC ACETAZOLAMIDE, ACETAZOLAMIDE ALPRAZOLAM, ALPRAZOLAM AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE ANASTROZOLE, ANASTROZOLE ATOMOXETINE HYDROCHLORIDE, ATOMOXETINE HYDROCHLORIDE BICALUTAMIDE, BICALUTAMIDE BROMOCRIPTINE MESYLATE, BROMOCRIPTINE MESYLATE CARVEDILOL, CARVEDILOL DIPYRIDAMOLE, DIPYRIDAMOLE DIVALPROEX SODIUM, DIVALPROEX SODIUM DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE FINASTERIDE, FINASTERIDE GABAPENTIN, GABAPENTIN GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE INDOMETHACIN, INDOMETHACIN LAMOTRIGINE, LAMOTRIGINE LEVETIRACETAM, LEVETIRACETAM LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM, LOSARTAN POTASSIUM MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
RAMIPRIL, RAMIPRIL

RISPERIDONE, RISPERIDONE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

B - 151

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** Z **

* ZYDUS PHARMACEUTICALS USA INC ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE TOPIRAMATE, TOPIRAMATE TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

32ND EDITION - 2011 - APPROVED DRUG PRODUCTS LIST

C-1

APPENDIX C
UNIFORM TERMS
DOSAGE FORMS

AEROSOL AEROSOL, FOAM AEROSOL, METERED CAPSULE CAPSULE, DELAYED REL PELLETS CAPSULE, DELAYED RELEASE CAPSULE, EXTENDED RELEASE CLOTH CONCENTRATE CREAM CREAM, AUGMENTED ELIXIR EMULSION ENEMA FILM FILM, EXTENDED RELEASE FOR SOLUTION FOR SOLUTION, TABLET, FOR SOLUTION FOR SUSPENSION FOR SUSPENSION, DELAYED RELEASE FOR SUSPENSION, EXTENDED RELEASE GAS GEL GEL, AUGMENTED GEL, METERED GRANULE GRANULE, DELAYED RELEASE GUM, CHEWING IMPLANT INHALANT INJECTABLE INJECTABLE, LIPID COMPLEX INJECTABLE, LIPOSOMAL INSERT INSERT, EXTENDED RELEASE INTRAUTERINE DEVICE JELLY LIQUID LOTION LOTION, AUGMENTED LOTION/SHAMPOO OIL OIL/DROPS OINTMENT OINTMENT, AUGMENTED PASTE PATCH PELLET POWDER POWDER, EXTENDED RELEASE POWDER, METERED RING SHAMPOO SOLUTION SOLUTION FOR SLUSH SOLUTION, GEL FORMING/DROPS SOLUTION, METERED SOLUTION/DROPS SPONGE SPRAY SPRAY, METERED SUPPOSITORY SUSPENSION SUSPENSION, EXTENDED RELEASE SUSPENSION/DROPS SWAB SYRUP SYSTEM, EXTENDED RELEASE TABLET TABLET, CHEWABLE TABLET, COATED PARTICLES TABLET, DELAYED RELEASE TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING TABLET, EFFERVESCENT TABLET, EXTENDED RELEASE TABLET, FOR SUSPENSION TABLET, ORALLY DISINTEGRATING TAPE TROCHE/LOZENGE

Note: Terms comprise currently marketed products

32ND EDITION - 2011 - APPROVED DRUG PRODUCTS LIST

C-2

APPENDIX C UNIFORM TERMS ROUTES OF ADMINISTRATION

BUCCAL DENTAL ENDOCERVICAL EPIDURAL FOR RX COMPOUNDING IM-IV IM-IV-SC IMPLANTATION IM-SC INHALATION INJECTION INTRA-ANAL INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL INTRACRANIAL INTRAMUSCULAR INTRAOCULAR INTRAPERITONEAL INTRAPLEURAL INTRATHECAL INTRATRACHEAL INTRAUTERINE INTRAVENOUS INTRAVESICAL INTRAVITREAL IRRIGATION IV (INFUSION) IV (INFUSION)-SC IV-SC N/A NASAL OPHTHALMIC ORAL ORAL-21 ORAL-28 OTIC PERFUSION, CARDIAC PERIODONTAL RECTAL SPINAL SUBCUTANEOUS SUBLINGUAL TOPICAL TRANSDERMAL TRANSMUCOSAL URETHRAL VAGINAL

Note: Terms comprise currently marketed products

32ND EDITION - 2011 - APPROVED DRUG PRODUCTS LIST

C-3

APPENDIX C
UNIFORM TERMS

ABBREVIATIONS

AMP AMPICIL APPROX BOT CI CSR CU DIPROP ELECT EQ ER GM HBR HCL HR INH IU KIU MCG MCI MEQ MG ML N/A PPM REL SQ CM U UCI UMOLAR USP

AMPULE AMPICILLIN APPROXIMATELY BOTTLE CURIE CAROTID SINUS REFLEX CLINICAL UNITS DIPROPIONATE ELECTROLYTE EQUIVALENT TO EXTENDED RELEASE GRAM HYDROBROMIDE HYDROCHLORIDE HOUR INHALATION INTERNATIONAL UNITS KALLIKREIN INHIBITOR UNITS MICROGRAM MILLICURIE MILLIEQUIVALENT MILLIGRAM MILLILITER NOT APPLICABLE PARTS PER MILLION RELEASE SQUARE CENTIMETER UNITS MICROCURIE MICROMOLAR UNITED STATES PHARMACOPEIA

PATENT AND EXCLUSIVITY INFORMATION ADDENDUM

This Addendum identifies drugs that qualify under the Drug Price Competition and Patent Term Restoration Act (1984 Amendments) for periods of exclusivity, during which abbreviated new drug applications (ANDAs) and applications described in Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (the Act) for those drug products may, in some instances, not be submitted or made effective as described below, and provides patent information concerning the listed drug products. Those drugs that have qualified for Orphan Drug Exclusivity pursuant to Section 527 of the Act and those drugs that have qualified for Pediatric Exclusivity pursuant to Section 505A are also included in this Addendum. This section is arranged in alphabetical order by active ingredient name followed the trade name. Active ingredient headings for multiple ingredient (combination) drug products are arranged alphabetically. For an explanation of the codes used in the Addendum, see the Patent and Exclusivity Terms Section. Exclusivity prevents the submission or effective approval of ANDAs or applications described in Section 505(b)(2) of the Act. It does not prevent the submission or approval of a second 505(b)(1) application except in the case of Orphan Drug exclusivity. Applications qualifying for periods of exclusivity are: (1) A new drug application approved after September 24, 1984, for a drug product all active ingredients (including any ester or salt of the active ingredient) of which had never been approved in any other new drug application under Section 505 (b) of the Act. No subsequent ANDA or application described in Section 505(b)(2) of the Act for the same drug may be submitted for a period of five years from the date of approval of the original application, except that such an application may be submitted after four years if it contains a certification that a patent claiming the drug is invalid or will not be infringed by the product for which approval is sought. (2) A new drug application approved after September 24, 1984, for a drug product containing an active ingredient (including any ester or salt of that active ingredient) that has been approved in an earlier new drug application and that includes reports of new clinical investigations (other than bioavailability studies). Such investigations must have been conducted or sponsored by the applicant and must have been essential to approval of the application. If these requirements are met, the approval of a subsequent ANDA or an application described in Section 505(b)(2) of the Act may not be made effective for the same drug or use, if for a new indication, before the expiration of three years from the date of approval of the original application. If an applicant has exclusivity for a new application or 505(b)(2) application for the drug product with indications or use, this does not preclude the approval of an ANDA or 505(b)(2) application not covered by the exclusivity. (3) A supplement to a new drug application for a drug containing a previously approved active ingredient including (any ester or salt of the active ingredient) approved after September 24, 1984, that contains reports of new clinical investigations (other than bioavailability studies) essential to the approval of the supplement and conducted or sponsored by the applicant. The approval of a subsequent ANDA or 505(b)(2) application for a change approved in the supplement may not be

AD 1

made effective for three years from the date of approval of the original supplement.

The Act requires that patent information be filed with all newly submitted Section 505(b) drug applications. No NDA may be approved after September 24, 1984, without the submission of patent information to the Agency. Effective August 18, 2003, this information must be filed using FDA Form 3524a Patent Information Submitted with the Filing of an NDA, Amendment or Supplement. Effective August 18, 2003, upon approval of an application, patent information for purposes of listing in the Orange Book must be submitted to the agency within 30 days of approval on FDA Form 3542 Patent Information Submitted Upon and After Approval of an NDA or Supplement. Patent information on unapproved applications or on patents beyond the scope of the Act (i.e., process or manufacturing patents) will not be published. FDA form 3542 will be the only form used for the purposes of this publication. The patents that FDA regards as covered by the statutory provisions for submission of patent information are: patents that claim the active ingredient(s); drug product patents which include formulation/composition patents; use patents for a particular approved indication or method of using the product; and certain other patents as detailed on FDA Form 3542. This information, as provided by the sponsor on FDA form 3542, will be published as described above. A requirement for submission of patent information to FDA for certain old antibiotics became effective October 7, 2008 under section 4(b)(1) of the Q1 Act. A guidance for industry on this subject is available at http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM048345.pdf Upon approval, patent numbers and expiration dates, in addition to certain other information on appropriate patents claiming drug products that are the subject of approved applications, will be published daily in the Electronic Orange Book Query. The Addendum lists patent and exclusivity information up to January of the Edition year. The monthly Cumulative Supplements to the annual edition list patent and exclusivity information changes since the Annual Edition Addendum. Since all parts of this publication are subject to changes, additions, or deletions, the Electronic Orange Book, updated daily, should be consulted for the most recent patent and exclusivity information.

AD 2

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 1 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DS DS DP DP U-65 U-65

EXCLUSIVITY CODE(S)

ABACAVIR SULFATE - ZIAGEN N020977 001 5034394 5034394*PED 6294540 6294540*PED ABACAVIR SULFATE - ZIAGEN N020978 001 5034394 5034394*PED 6294540 6294540*PED 6641843 6641843*PED

Dec Jun May Nov

18, 18, 14, 14,

2011 2012 2018 2018

Dec Jun May Nov Feb Aug

18, 18, 14, 14, 04, 04,

2011 2012 2018 2018 2019 2019

DS DS

DP DP DP U-65 U-65

ABACAVIR SULFATE; LAMIVUDINE - EPZICOM N021652 001 5034394 Dec 18, 5034394*PED Jun 18, 5905082 May 18, Nov 18, 5905082*PED May 14, 6294540 Nov 14, 6294540*PED Mar 28, 6417191

2011 2012 2016 2016 2018 2018 2016

DS DS DS

DP DP DP DP U-257 U-257

ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE - TRIZIVIR DS N021205 001 5034394 Dec 18, 2011 5034394*PED Jun 18, 2012 DS 5905082 May 18, 2016 Nov 18, 2016 5905082*PED May 14, 2018 DS 6294540 Nov 14, 2018 6294540*PED Mar 28, 2016 6417191 ABARELIX - PLENAXIS N021320 001 5843901 5968895 6180608 6423686 6455499 6699833 ABIRATERONE ACETATE - ZYTIGA N202379 001 5604213 ACETAMINOPHEN - OFIRMEV N022450 001 6028222 6992218

DP DP DP DP U-248 U-65 U-65 U-248

Dec Dec Dec Jun Jun Dec

01, 11, 11, 07, 07, 11,

2015 2016 2016 2015 2015 2016

DS

DP DP DP

U-549 U-549

DS DP

Feb

18, 2014

DS

DP

U-1126

NCE

Apr

28, 2016

Aug Jun

05, 2017 06, 2021

DP DP

NP

Nov

02, 2013

ACETAMINOPHEN; ASPIRIN; CAFFEINE - EXCEDRIN (MIGRAINE) N020802 001 5972916 Jul 14, 2017 U-296 ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE - ULTRACET DS N021123 001 RE39221 Aug 09, 2011 ACETYLCHOLINE CHLORIDE - MIOCHOL-E N020213 001 6261546 Apr ACYCLOVIR; HYDROCORTISONE - XERESE N022436 001 6514980 Jan 7223387 Feb RE39264 Feb ADAPALENE - DIFFERIN N021753 001 7579377 7737181 7834060 7838558 7868044 ADAPALENE - DIFFERIN N022502 001 7998467

DP

U-55

29, 2019

U-506

24, 2017 28, 2021 02, 2016

DP DP DP

U-1006 U-1006 U-1006

NC

Jul

31, 2012

Feb Aug Mar Mar Mar

23, 29, 12, 12, 12,

2025 2024 2023 2023 2023

U-818 DP U-1078 DP U-1078

May

31, 2028

DP

U-1078

NDF

Mar

17, 2013

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 2 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DP DP DP

EXCLUSIVITY CODE(S)
NC

ADAPALENE; BENZOYL PEROXIDE - EPIDUO N022320 001 7820186 Nov 23, 2025 7964202 Sep 01, 2024 8071644 Jul 18, 2027 8080537 Jul 18, 2027 ADEFOVIR DIPIVOXIL - HEPSERA N021449 001 5663159 6451340 ADENOSINE - ADENOSCAN N020059 001 5731296

Dec

08, 2011

U-1078 U-1078 U-1078

Sep Jul

02, 2014 23, 2018

DS DS

DP DP

U-470

Mar

24, 2015

U-221

ALATROFLOXACIN MESYLATE - TROVAN PRESERVATIVE FREE N020760 001 5763454 Jun 15, 2015 6080756 Jul 05, 2016 6194429 Jul 23, 2018 ALATROFLOXACIN MESYLATE - TROVAN PRESERVATIVE FREE N020760 002 5763454 Jun 15, 2015 6080756 Jul 05, 2016 6194429 Jul 23, 2018 ALBUMIN HUMAN - OPTISON N020899 001 5529766 5558094 5573751 6723303 ALBUTEROL SULFATE - ACCUNEB N020949 001 6702997 ALBUTEROL SULFATE - ACCUNEB N020949 002 6702997

U-282

U-282

Jun Feb Apr Apr

25, 28, 25, 20,

2013 2012 2012 2021

U-505 U-505 DP

Dec

28, 2021

U-558

Dec

28, 2021

U-558

ALBUTEROL SULFATE - PROAIR HFA N021457 001 5605674 Feb 7105152 Sep 7566445 Jun ALBUTEROL SULFATE - PROVENTIL-HFA N020503 001 5605674 Feb 5766573 Jun

25, 2014 12, 2023 04, 2017

DP DP DP

NPP

Sep

16, 2011

25, 2014 16, 2015

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 3 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DP DP DP DP DP DP DP DP U-716 DP DP DP DP DP DP DP U-716

EXCLUSIVITY CODE(S)

ALBUTEROL SULFATE - VENTOLIN HFA N020983 001 6161724 Jan 6161724*PED Jul 6170717 Dec 6170717*PED Jun 6315173 Dec 6315173*PED Jun 6431168 Jun 6431168*PED Dec 6435372 Jan 6435372*PED Jul 6510969 Dec 6510969*PED Jun 6558651 Dec 6558651*PED Jun 6596260 Aug 6596260*PED Feb 6743413 Jun 6743413*PED Dec 6938796 Jan 6938796*PED Jul 6966467 Dec 6966467*PED Jun 6997349 Jan 6997349*PED Jul 7107986 Jun 7107986*PED Dec 7143908 Jan 7143908*PED Jul 7350676 Aug 7350676*PED Feb 7500444 Jan 7500444*PED Jul

16, 16, 23, 23, 23, 23, 08, 08, 16, 16, 23, 23, 19, 19, 10, 10, 01, 01, 16, 16, 23, 23, 16, 16, 08, 06, 16, 16, 24, 24, 04, 04,

2018 2018 2017 2018 2017 2018 2018 2018 2018 2018 2017 2018 2016 2017 2014 2015 2021 2021 2018 2018 2017 2018 2018 2018 2018 2018 2018 2018 2018 2019 2025 2025

ALBUTEROL SULFATE; IPRATROPIUM BROMIDE - COMBIVENT N020291 001 5603918 Jun 09, 2015 ALBUTEROL SULFATE; IPRATROPIUM N021747 001 5405084 5472143 5497944 5662271 5911851 5964416 6007676 6149054 6176442 6453795 6503362 6726124 6846413 6977042 6988496 7104470 7246615 7284474 7396341 7802568 7837235 7896264 7988001 BROMIDE - COMBIVENT RESPIMAT DP Apr 11, 2012 DP Sep 29, 2013 DP Mar 12, 2013 DP Sep 02, 2014 DP Sep 29, 2013 Oct 04, 2016 DP DP Sep 29, 2013 DP Dec 19, 2016 DP Oct 04, 2016 Dec 05, 2016 DP DP Sep 29, 2013 DP Oct 04, 2016 DP Aug 28, 2018 DP Aug 28, 2018 Feb 23, 2020 DP DP Oct 04, 2016 DP May 31, 2016 DP Aug 26, 2024 DP Oct 10, 2026 Feb 26, 2019 DP DP Mar 13, 2028 DP May 26, 2025 DP Aug 04, 2021

NP

Oct

07, 2014

ALBUTEROL SULFATE; IPRATROPIUM BROMIDE - DUONEB N020950 001 6632842 Dec 28, 2021 ALCAFTADINE - LASTACAFT N022134 001 5468743

U-532

Nov

21, 2012

DS

DP

NCE

Jul

28, 2015

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 4 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)

ALCOHOL; CHLORHEXIDINE GLUCONATE - AVAGARD Jun 21, 2016 N021074 001 5897031 Jun 22, 2015 6090395 Jun 22, 2015 6534069 Jun 23, 2015 6623744 Aug 03, 2016 7081246 Jun 22, 2015 7566460 ALENDRONATE SODIUM - FOSAMAX N020560 001 5358941 5358941*PED 5681590 5681590*PED 6090410 6090410*PED 6194004 6194004*PED ALENDRONATE SODIUM - FOSAMAX N020560 002 5358941 5358941*PED 5681590 5681590*PED 6090410 6090410*PED ALENDRONATE SODIUM - FOSAMAX N020560 003 5358941 5358941*PED 5681590 5681590*PED 6090410 6090410*PED ALENDRONATE SODIUM - FOSAMAX N020560 004 5358941 5358941*PED 5681590 5681590*PED 6090410 6090410*PED ALENDRONATE SODIUM - FOSAMAX N020560 005 5358941 5358941*PED 5681590 5681590*PED 6090410 6090410*PED ALENDRONATE SODIUM - FOSAMAX N021575 001 5462932 5462932*PED 5994329 5994329*PED 6015801 6015801*PED 6225294 6225294*PED

DP DP U-1008 DP DP U-1008

Dec Jun Dec Jun Dec Jun Dec Jun

02, 02, 02, 02, 02, 02, 02, 02,

2012 2013 2012 2013 2012 2013 2012 2013

Dec Jun Dec Jun Dec Jun

02, 02, 02, 02, 02, 02,

2012 2013 2012 2013 2012 2013

Dec Jun Dec Jun Dec Jun

02, 02, 02, 02, 02, 02,

2012 2013 2012 2013 2012 2013

Dec Jun Dec Jun Dec Jun

02, 02, 02, 02, 02, 02,

2012 2013 2012 2013 2012 2013

Dec Jun Dec Jun Dec Jun

02, 02, 02, 02, 02, 02,

2012 2013 2012 2013 2012 2013

May Nov Jul Jan Jul Jan Jul Jan

17, 17, 17, 17, 17, 17, 17, 17,

2014 2014 2018 2019 2018 2019 2018 2019

Y Y Y

ALENDRONATE SODIUM; CHOLECALCIFEROL N021762 001 5358941 Dec 5358941*PED Jun 5681590 Dec 5681590*PED Jun 5994329 Jul 5994329*PED Jan 6090410 Dec 6090410*PED Jun

- FOSAMAX PLUS D 02, 2012 DP 02, 2013 DP 02, 2012 02, 2013 17, 2018 17, 2019 DP 02, 2012 DP 02, 2013

U-647

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 5 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)

ALENDRONATE SODIUM; CHOLECALCIFEROL N021762 002 5358941 Dec 5358941*PED Jun 5681590 Dec 5681590*PED Jun 6090410 Dec 6090410*PED Jun

- FOSAMAX PLUS D 02, 2012 DP 02, 2013 DP 02, 2012 02, 2013 DP 02, 2012 DP 02, 2013

ALFUZOSIN HYDROCHLORIDE - ALFUZOSIN HYDROCHLORIDE A079013 001 ALFUZOSIN HYDROCHLORIDE - ALFUZOSIN HYDROCHLORIDE A079014 001 ALFUZOSIN HYDROCHLORIDE - ALFUZOSIN HYDROCHLORIDE A079054 001 ALFUZOSIN HYDROCHLORIDE - ALFUZOSIN HYDROCHLORIDE A079056 001 ALFUZOSIN HYDROCHLORIDE - ALFUZOSIN HYDROCHLORIDE A079057 001 ALFUZOSIN HYDROCHLORIDE - UROXATRAL N021287 001 4661491*PED Jul 18, 2011 6149940 Aug 22, 2017 6149940*PED Feb 22, 2018 ALISKIREN HEMIFUMARATE - TEKTURNA N021985 001 5559111 Jul ALISKIREN HEMIFUMARATE - TEKTURNA N021985 002 5559111 Jul

PC

Jan

14, 2012

PC

Jan

14, 2012

PC

Jan

14, 2012

PC

Jan

14, 2012

PC

Jan

14, 2012

M-97 PED

Dec Jun

15, 2013 15, 2014

21, 2018

DS

DP

U-3

NCE

Mar

05, 2012

21, 2018

DS

DP

U-3

NCE

Mar

05, 2012

ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE - TEKAMLO N022545 001 ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE - TEKAMLO N022545 002 ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE - TEKAMLO N022545 003 ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE - TEKAMLO N022545 004 ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE - AMTURNIDE N200045 001 5559111 Jul 21, 2018 DS DP U-3 ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE - AMTURNIDE N200045 002 5559111 Jul 21, 2018 DS DP U-3 ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE - AMTURNIDE N200045 003 5559111 Jul 21, 2018 DS DP U-3 ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE - AMTURNIDE N200045 004 5559111 Jul 21, 2018 DS DP U-3 ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE - AMTURNIDE N200045 005 5559111 Jul 21, 2018 DS DP U-3

NC NCE

Aug Mar

26, 2013 05, 2012

NC NCE

Aug Mar

26, 2013 05, 2012

NC NCE

Aug Mar

26, 2013 05, 2012

NC NCE

Aug Mar

26, 2013 05, 2012

NCE NC

Mar Dec

05, 2012 21, 2013

NCE NC

Mar Dec

05, 2012 21, 2013

NCE NC

Mar Dec

05, 2012 21, 2013

NCE NC

Mar Dec

05, 2012 21, 2013

NCE NC

Mar Dec

05, 2012 21, 2013

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 6 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)
I-600 NCE

ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE - TEKTURNA HCT N022107 001 5559111 Jul 21, 2018 DS DP U-3 ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE - TEKTURNA HCT N022107 002 5559111 Jul 21, 2018 DS DP U-3 ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE - TEKTURNA HCT N022107 003 5559111 Jul 21, 2018 DS DP U-3 ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE - TEKTURNA HCT N022107 004 5559111 Jul 21, 2018 DS DP U-3 ALISKIREN HEMIFUMARATE; VALSARTAN - VALTURNA N022217 001 5399578 Mar 21, 2012 5559111 Jul 21, 2018 ALISKIREN HEMIFUMARATE; VALSARTAN - VALTURNA N022217 002 5399578 Mar 21, 2012 5559111 Jul 21, 2018 ALITRETINOIN - PANRETIN N020886 001 5932622 ALMOTRIPTAN MALATE - AXERT N021001 001 5565447 5565447*PED ALMOTRIPTAN MALATE - AXERT N021001 002 5565447 5565447*PED

Jul Mar

16, 2012 05, 2012

I-600 NCE

Jul Mar

16, 2012 05, 2012

I-600 NCE

Jul Mar

16, 2012 05, 2012

I-600 NCE

Jul Mar

16, 2012 05, 2012

DS DS

DP DP

U-3 U-3

NCE NC

Mar Sep

05, 2012 16, 2012

DS DS

DP DP

U-3 U-3

NCE NC

Mar Sep

05, 2012 16, 2012

Aug

03, 2016

U-562

May Nov

07, 2015 07, 2015

DS

DP

U-969

May Nov

07, 2015 07, 2015

DS

DP

U-969

ALOSETRON HYDROCHLORIDE - LOTRONEX N021107 001 5360800 Jan 6284770 Oct ALOSETRON HYDROCHLORIDE - LOTRONEX N021107 002 5360800 Jan 6284770 Oct ALPRAZOLAM - NIRAVAM N021726 001 6024981 6221392 ALPRAZOLAM - NIRAVAM N021726 002 6024981 6221392 ALPRAZOLAM - NIRAVAM N021726 003 6024981 6221392 ALPRAZOLAM - NIRAVAM N021726 004 6024981 6221392 ALPROSTADIL - CAVERJECT N020379 001 5741523 ALPROSTADIL - CAVERJECT N020379 002 5741523 ALPROSTADIL - CAVERJECT N020379 003 5741523 ALPROSTADIL - CAVERJECT N020379 004 5741523

13, 2013 05, 2018

DS

DP

U-405 U-405

13, 2013 05, 2018

DS

DP

U-405 U-405

Apr Apr

09, 2018 09, 2018

DP DP

Apr Apr

09, 2018 09, 2018

DP DP

Apr Apr

09, 2018 09, 2018

DP DP

Apr Apr

09, 2018 09, 2018

DP DP

Apr

21, 2015

Apr

21, 2015

Apr

21, 2015

Apr

21, 2015

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 7 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DP DP

EXCLUSIVITY CODE(S)

ALPROSTADIL - CAVERJECT IMPULSE Apr N021212 001 5501673 Feb 5716338 ALPROSTADIL - CAVERJECT IMPULSE N021212 002 5501673 Apr 5716338 Feb ALPROSTADIL - MUSE N020700 001 5474535 5886039 ALPROSTADIL - MUSE N020700 002 5474535 5886039 ALPROSTADIL - MUSE N020700 003 5474535 5886039 ALPROSTADIL - MUSE N020700 004 5474535 5886039 ALVIMOPAN - ENTEREG N021775 001 5250542 5434171 6469030 AMBRISENTAN - LETAIRIS N022081 001 5703017 5840722 7109205 7601730 RE42462 AMBRISENTAN - LETAIRIS N022081 002 5703017 5840722 7109205 7601730 RE42462 AMIFOSTINE - ETHYOL N020221 001 5424471 5591731 5994409 AMIFOSTINE - ETHYOL N020221 002 5424471 5591731 5994409

16, 2013 10, 2015

16, 2013 10, 2015

DP DP

Dec Mar

12, 2012 23, 2016

DP

U-155 U-155

Dec Mar

12, 2012 23, 2016

DP

U-155 U-155

Dec Mar

12, 2012 23, 2016

DP

U-155 U-155

Dec Mar

12, 2012 23, 2016

DP

U-155 U-155

Mar Dec Nov

29, 2016 08, 2013 29, 2020

DS DS

DP DP

U-878 U-878 U-879

NCE

May

20, 2013

Dec Nov Oct Oct Oct

30, 24, 07, 07, 07,

2014 2015 2015 2015 2015

DS U-821 DS DS DP U-1080

NCE ODE

Jun Jun

15, 2012 15, 2014

Dec Nov Oct Oct Oct

30, 24, 07, 07, 07,

2014 2015 2015 2015 2015

DS U-821 DS DS DP U-1080

NCE ODE

Jun Jun

15, 2012 15, 2014

Jul Jul Dec

31, 2012 31, 2012 08, 2017

U-305

Jul Jul Dec

31, 2012 31, 2012 08, 2017 LEVULAN 30, 2013 31, 2017 01, 2018 17, 2019

U-305

AMINOLEVULINIC ACID HYDROCHLORIDE Sep N020965 001 5079262 Oct 5954703 May 6709446 Jun 7723910

U-289 U-289 U-289 U-289

M-82

Mar

12, 2013

AMIODARONE HYDROCHLORIDE - NEXTERONE N022325 001 6869939 May 04, 2022 7635773 Mar 13, 2029 AMIODARONE HYDROCHLORIDE - NEXTERONE May 04, 2022 N022325 002 6869939 Mar 13, 2029 7635773 AMIODARONE HYDROCHLORIDE - NEXTERONE May 04, 2022 N022325 003 6869939 Mar 13, 2029 7635773

DP DP

DP DP

DP DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 8 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-243

EXCLUSIVITY CODE(S)

AMLEXANOX - APHTHASOL N020511 001 5362737

Nov

08, 2011

AMLODIPINE BESYLATE - AMLODIPINE BESYLATE N022026 001 6828339 Nov 20, 2022 AMLODIPINE BESYLATE - AMLODIPINE BESYLATE N022026 002 6828339 Nov 20, 2022 AMLODIPINE BESYLATE - AMLODIPINE BESYLATE N022026 003 6828339 Nov 20, 2022

DS

DS

DS

AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET N021540 001 5686104 Nov 11, 2014 5686104*PED May 11, 2015 5969156 Jul 08, 2016 DS 5969156*PED Jan 08, 2017 6126971 Jan 19, 2013 6126971*PED Jul 19, 2013 6455574 Aug 11, 2018 AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET N021540 002 5686104 Nov 11, 2014 5686104*PED May 11, 2015 5969156 Jul 08, 2016 DS 5969156*PED Jan 08, 2017 6126971 Jan 19, 2013 6126971*PED Jul 19, 2013 6455574 Aug 11, 2018 AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET N021540 003 5686104 Nov 11, 2014 5686104*PED May 11, 2015 5969156 Jul 08, 2016 DS 5969156*PED Jan 08, 2017 6126971 Jan 19, 2013 6126971*PED Jul 19, 2013 6455574 Aug 11, 2018 AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET N021540 004 5686104 Nov 11, 2014 5686104*PED May 11, 2015 DS 5969156 Jul 08, 2016 5969156*PED Jan 08, 2017 6126971 Jan 19, 2013 6126971*PED Jul 19, 2013 6455574 Aug 11, 2018 AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET N021540 005 5686104 Nov 11, 2014 5686104*PED May 11, 2015 DS 5969156 Jul 08, 2016 5969156*PED Jan 08, 2017 6126971 Jan 19, 2013 6126971*PED Jul 19, 2013 6455574 Aug 11, 2018 AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET N021540 006 5686104 Nov 11, 2014 5686104*PED May 11, 2015 DS 5969156 Jul 08, 2016 5969156*PED Jan 08, 2017 6126971 Jan 19, 2013 6126971*PED Jul 19, 2013 6455574 Aug 11, 2018

DP

U-213

DP U-552

DP

U-213

DP U-552

DP

U-213

DP U-552

DP

U-213

DP U-552

DP

U-213

DP U-552

DP

U-213

DP U-552

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 9 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DP U-213

EXCLUSIVITY CODE(S)

AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET N021540 007 5686104 Nov 11, 2014 5686104*PED May 11, 2015 DS 5969156 Jul 08, 2016 5969156*PED Jan 08, 2017 6126971 Jan 19, 2013 6126971*PED Jul 19, 2013 6455574 Aug 11, 2018 AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET N021540 008 5686104 Nov 11, 2014 5686104*PED May 11, 2015 DS 5969156 Jul 08, 2016 5969156*PED Jan 08, 2017 6126971 Jan 19, 2013 6126971*PED Jul 19, 2013 6455574 Aug 11, 2018 AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET N021540 009 5686104 Nov 11, 2014 5686104*PED May 11, 2015 DS 5969156 Jul 08, 2016 5969156*PED Jan 08, 2017 6126971 Jan 19, 2013 6126971*PED Jul 19, 2013 6455574 Aug 11, 2018 AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET N021540 010 5686104 Nov 11, 2014 5686104*PED May 11, 2015 DS 5969156 Jul 08, 2016 5969156*PED Jan 08, 2017 6126971 Jan 19, 2013 6126971*PED Jul 19, 2013 6455574 Aug 11, 2018 AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET N021540 011 5686104 Nov 11, 2014 5686104*PED May 11, 2015 DS 5969156 Jul 08, 2016 5969156*PED Jan 08, 2017 6126971 Jan 19, 2013 6126971*PED Jul 19, 2013 6455574 Aug 11, 2018

DP U-552

DP

U-213

DP U-552

DP

U-213

DP U-552

DP

U-213

DP U-552

DP

U-213

DP U-552

AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE - AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE A078381 005 PC Jul 02, 2011 AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE - AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE A078381 006 PC Jul 02, 2011 AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE - LOTREL N020364 002 6162802 Dec 19, 2017 U-367 AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE - LOTREL N020364 003 6162802 Dec 19, 2017 U-367 AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE - LOTREL N020364 004 6162802 Dec 19, 2017 U-367 AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE - LOTREL N020364 005 6162802 Dec 19, 2017 U-367 AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE - LOTREL N020364 006 6162802 Dec 19, 2017 DS DP U-185 AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE - LOTREL N020364 007 6162802 Dec 19, 2017 DS DP U-185

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 10 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)
NC

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL - TRIBENZOR N200175 001 5616599 Apr 25, 2016 DS DP U-3 5616599*PED Oct 25, 2016 AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL - TRIBENZOR N200175 002 5616599 Apr 25, 2016 DS DP U-3 5616599*PED Oct 25, 2016 AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL - TRIBENZOR N200175 003 5616599 Apr 25, 2016 DS DP U-3 5616599*PED Oct 25, 2016 AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL - TRIBENZOR N200175 004 5616599 Apr 25, 2016 DS DP U-3 5616599*PED Oct 25, 2016 AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL - TRIBENZOR N200175 005 5616599 Apr 25, 2016 DS DP U-3 5616599*PED Oct 25, 2016 AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN - EXFORGE HCT N022314 001 5399578 Mar 21, 2012 DS DP U-3 5399578*PED Sep 21, 2012 DP U-3 6294197 Jun 18, 2017 6294197*PED Dec 18, 2017 AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN - EXFORGE HCT N022314 002 5399578 Mar 21, 2012 DS DP U-3 5399578*PED Sep 21, 2012 6294197 Jun 18, 2017 DP U-3 6294197*PED Dec 18, 2017 AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN - EXFORGE HCT N022314 003 5399578 Mar 21, 2012 DS DP U-3 5399578*PED Sep 21, 2012 DP U-3 6294197 Jun 18, 2017 6294197*PED Dec 18, 2017 AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN - EXFORGE HCT N022314 004 5399578 Mar 21, 2012 DS DP U-3 5399578*PED Sep 21, 2012 DP U-3 6294197 Jun 18, 2017 6294197*PED Dec 18, 2017 AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN - EXFORGE HCT N022314 005 5399578 Mar 21, 2012 DS DP U-3 5399578*PED Sep 21, 2012 6294197 Jun 18, 2017 DP U-3 6294197*PED Dec 18, 2017 AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL - AZOR N022100 001 5616599 Apr 25, 2016 DS 5616599*PED Oct 25, 2016 AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL - AZOR N022100 002 5616599 Apr 25, 2016 DS 5616599*PED Oct 25, 2016 AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL - AZOR N022100 003 5616599 Apr 25, 2016 DS 5616599*PED Oct 25, 2016 AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL - AZOR N022100 004 5616599 Apr 25, 2016 DS 5616599*PED Oct 25, 2016 AMLODIPINE BESYLATE; TELMISARTAN - TWYNSTA N022401 001 5591762 Jan 07, 2014 AMLODIPINE BESYLATE; TELMISARTAN - TWYNSTA N022401 002 5591762 Jan 07, 2014

Jul

23, 2013

NC

Jul

23, 2013

NC

Jul

23, 2013

NC

Jul

23, 2013

NC

Jul

23, 2013

NC

Apr

30, 2012

NC

Apr

30, 2012

NC

Apr

30, 2012

NC

Apr

30, 2012

NC

Apr

30, 2012

DP

U-3

DP

U-3

DP

U-3

DP

U-3

DS

DP

U-3

NC

Oct

16, 2012

DS

DP

U-3

NC

Oct

16, 2012

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 11 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DS DP U-3

EXCLUSIVITY CODE(S)
NC

AMLODIPINE BESYLATE; TELMISARTAN - TWYNSTA N022401 003 5591762 Jan 07, 2014 AMLODIPINE BESYLATE; TELMISARTAN - TWYNSTA N022401 004 5591762 Jan 07, 2014 AMLODIPINE BESYLATE; VALSARTAN N021990 002 5399578 5399578*PED 6294197 6294197*PED 6395728 AMLODIPINE BESYLATE; VALSARTAN N021990 003 5399578 5399578*PED 6294197 6294197*PED 6395728 AMLODIPINE BESYLATE; VALSARTAN N021990 004 5399578 5399578*PED 6294197 6294197*PED 6395728 AMLODIPINE BESYLATE; VALSARTAN N021990 005 5399578 5399578*PED 6294197 6294197*PED 6395728 AMMONIA, N-13 - AMMONIA N 13 N022119 001 AMOXICILLIN - MOXATAG N050813 001 6544555 6669948 6723341 - EXFORGE Mar 21, 2012 Sep 21, 2012 Jun 18, 2017 Dec 18, 2017 Jul 08, 2019 - EXFORGE Mar 21, 2012 Sep 21, 2012 Jun 18, 2017 Dec 18, 2017 Jul 08, 2019 - EXFORGE Mar 21, 2012 Sep 21, 2012 Jun 18, 2017 Dec 18, 2017 Jul 08, 2019 - EXFORGE Mar 21, 2012 Sep 21, 2012 Jun 18, 2017 Dec 18, 2017 Jul 08, 2019

Oct

16, 2012

DS

DP

U-3

NC

Oct

16, 2012

DS

DP DP DP

U-3 U-3

DS

DP DP DP

U-3 U-3

DS

DP DP DP

U-3 U-3

DS

DP DP DP

U-3 U-3

NCE W Oct Oct Oct 13, 2020 13, 2020 13, 2020 DS DS DS DP DP DP U-897 U-897 U-897

Aug Aug

23, 2012 23, 2012

AMOXICILLIN; CLAVULANATE POTASSIUM - AUGMENTIN XR N050785 001 6746692 Apr 04, 2020 6783773 Apr 04, 2020 6878386 Apr 04, 2020 7217430 Apr 04, 2020 7250176 Apr 04, 2020

DP DP DP U-926 U-926 U-926

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE ADDERALL 10 N011522 007 6384020 Jul 06, 2020 6384020*PED Jan 06, 2021 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE ADDERALL 12.5 N011522 012 6384020 Jul 06, 2020 6384020*PED Jan 06, 2021 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE ADDERALL 15 N011522 013 6384020 Jul 06, 2020 6384020*PED Jan 06, 2021 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE ADDERALL 20 N011522 008 6384020 Jul 06, 2020 6384020*PED Jan 06, 2021

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 12 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE ADDERALL 30 N011522 010 6384020 Jul 06, 2020 6384020*PED Jan 06, 2021 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE ADDERALL 5 N011522 009 6384020 Jul 06, 2020 6384020*PED Jan 06, 2021 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE ADDERALL 7.5 N011522 011 6384020 Jul 06, 2020 6384020*PED Jan 06, 2021 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE ADDERALL XR 10 N021303 001 6322819 Oct 21, 2018 6322819*PED Apr 21, 2019 6605300 Oct 21, 2018 6605300*PED Apr 21, 2019 DP RE41148 Oct 21, 2018 RE41148*PED Apr 21, 2019 DP RE42096 Oct 21, 2018 RE42096*PED Apr 21, 2019 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE ADDERALL XR 15 N021303 006 6322819 Oct 21, 2018 6322819*PED Apr 21, 2019 6605300 Oct 21, 2018 6605300*PED Apr 21, 2019 DP RE41148 Oct 21, 2018 RE41148*PED Apr 21, 2019 RE42096 Oct 21, 2018 DP RE42096*PED Apr 21, 2019 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE ADDERALL XR 20 N021303 002 6322819 Oct 21, 2018 6322819*PED Apr 21, 2019 6605300 Oct 21, 2018 6605300*PED Apr 21, 2019 RE41148 Oct 21, 2018 DP RE41148*PED Apr 21, 2019 DP RE42096 Oct 21, 2018 RE42096*PED Apr 21, 2019 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE ADDERALL XR 25 N021303 004 6322819 Oct 21, 2018 6322819*PED Apr 21, 2019 6605300 Oct 21, 2018 6605300*PED Apr 21, 2019 DP RE41148 Oct 21, 2018 RE41148*PED Apr 21, 2019 DP RE42096 Oct 21, 2018 RE42096*PED Apr 21, 2019 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE ADDERALL XR 30 N021303 003 6322819 Oct 21, 2018 6322819*PED Apr 21, 2019 6605300 Oct 21, 2018 6605300*PED Apr 21, 2019 DP RE41148 Oct 21, 2018 RE41148*PED Apr 21, 2019 DP RE42096 Oct 21, 2018 RE42096*PED Apr 21, 2019

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 13 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE ADDERALL XR 5 N021303 005 6322819 Oct 21, 2018

6322819*PED Apr 21, 2019

6605300 Oct 21, 2018

6605300*PED Apr 21, 2019

DP
RE41148 Oct 21, 2018
RE41148*PED Apr 21, 2019

DP
RE42096 Oct 21, 2018
RE42096*PED Apr 21, 2019

AMPHOTERICIN B - ABELCET N050724 001 5616334 6406713 AMPHOTERICIN B - AMBISOME N050740 001 5874104 5965156 AMPRENAVIR - AGENERASE N021007 001 5585397 5646180 5723490 6730679 AMPRENAVIR - AGENERASE N021007 002 5585397 5646180 5723490 6730679 AMPRENAVIR - AGENERASE N021039 001 5585397 5646180 5723490 ANASTROZOLE - ARIMIDEX N020541 001 ANIDULAFUNGIN - ERAXIS N021632 001 5965525 6384013 6743777 6960564 7709444 ANIDULAFUNGIN - ERAXIS N021632 002 5965525 6384013 6743777 6960564 7709444 APREPITANT - EMEND N021549 001 5538982 5719147 6048859 6096742 6235735 6235735 7214692

Apr Jun

01, 2014 18, 2019

DS DS

Feb Oct

23, 2016 12, 2016

DP DP

U-922 U-922

Dec Jul Mar Nov

17, 08, 03, 11,

2013 2014 2015 2017

U-257 U-257 DP

Dec Jul Mar Nov

17, 08, 03, 11,

2013 2014 2015 2017

U-257 U-257 DP

Dec Jul Mar

17, 2013 08, 2014 03, 2015

U-257 U-257

M-61 PED Feb Mar Mar Apr Apr 17, 19, 19, 12, 12, 2020 2012 2012 2021 2021 DS DS DP DP DP DP U-540 U-540 U-540 U-540

Dec Jun

05, 2011 05, 2012

Feb Mar Mar Apr Apr

17, 19, 19, 12, 12,

2020 2012 2012 2021 2021

DS DS

DP DP DP DP

U-540 U-540 U-540 U-540

Jul Apr Jun Jul Jun Jun Sep

23, 17, 29, 01, 29, 29, 18,

2013 2015 2012 2018 2012 2012 2012

DS DS

DP DP

U-745 U-853 U-745 U-745 U-747 U-746 U-853

M-82

Mar

19, 2013

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 14 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-745 U-853 U-745 U-745 U-747 U-746 U-853

EXCLUSIVITY CODE(S)
M-82

APREPITANT - EMEND N021549 002 5538982 5719147 6048859 6096742 6235735 6235735 7214692 APREPITANT - EMEND N021549 003 5538982 5719147 6048859 6096742 6235735 6235735 7214692

Jul Apr Jun Jul Jun Jun Sep

23, 17, 29, 01, 29, 29, 18,

2013 2015 2012 2018 2012 2012 2012

Mar

19, 2013

DS DS

DP DP

Jul Apr Jun Jul Jun Jun Sep

23, 17, 29, 01, 29, 29, 18,

2013 2015 2012 2018 2012 2012 2012

DS DS

DP DP

U-745 U-853 U-745 U-745 U-747 U-746 U-853

M-82

Mar

19, 2013

ARBUTAMINE HYDROCHLORIDE - GENESA N020420 001 5395970 Mar ARFORMOTEROL TARTRATE - BROVANA Apr N021912 001 5795564 Nov 6040344 Apr 6068833 Nov 6472563 Apr 6589508 Nov 6720453 Apr 6866839 Nov 7145036 ARGATROBAN - ARGATROBAN N020883 001 5214052

07, 2012

03, 12, 03, 09, 03, 09, 03, 09,

2012 2016 2012 2021 2012 2021 2012 2021

U-793 DS U-793 DS U-793 DS U-793 DS

Jun

30, 2014

ARGATROBAN - ARGATROBAN IN SODIUM CHLORIDE Sep 26, 2027 N022434 001 7589106 Sep 26, 2027 7687516 ARIPIPRAZOLE - ABILIFY N021436 001 5006528 5006528*PED

DP DP

U-1163 U-1164

Oct Apr

20, 2014 20, 2015

DS

DP

U-761

I-633 I-616 PED

Feb Nov Aug

16, 2014 19, 2012 27, 2011

ARIPIPRAZOLE - ABILIFY N021436 002 5006528 5006528*PED

Oct Apr

20, 2014 20, 2015

DS

DP

U-761

I-633 I-616 PED

Feb Nov Aug

16, 2014 19, 2012 27, 2011

ARIPIPRAZOLE - ABILIFY N021436 003 5006528 5006528*PED

Oct Apr

20, 2014 20, 2015

DS

DP

U-761

I-633 I-616 PED

Feb Nov Aug

16, 2014 19, 2012 27, 2011

ARIPIPRAZOLE - ABILIFY N021436 004 5006528 5006528*PED

Oct Apr

20, 2014 20, 2015

DS

DP

U-761

I-633 I-616 PED

Feb Nov Aug

16, 2014 19, 2012 27, 2011

ARIPIPRAZOLE - ABILIFY N021436 005 5006528 5006528*PED

Oct Apr

20, 2014 20, 2015

DS

DP

U-761

I-633 I-616 PED

Feb Nov Aug

16, 2014 19, 2012 27, 2011

ARIPIPRAZOLE - ABILIFY N021436 006 5006528 5006528*PED

Oct Apr

20, 2014 20, 2015

DS

DP

U-761

I-633 I-616 PED

Feb Nov Aug

16, 2014 19, 2012 27, 2011

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 15 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DS DS DP DP U-761

EXCLUSIVITY CODE(S)
I-633 PED

ARIPIPRAZOLE - ABILIFY N021713 001 5006528 5006528*PED 6977257 6977257*PED ARIPIPRAZOLE - ABILIFY N021729 002 5006528 5006528*PED ARIPIPRAZOLE - ABILIFY N021729 003 5006528 5006528*PED ARIPIPRAZOLE - ABILIFY N021729 004 5006528 5006528*PED ARIPIPRAZOLE - ABILIFY N021729 005 5006528 5006528*PED ARIPIPRAZOLE - ABILIFY N021866 001 5006528 5006528*PED 7115587 7115587*PED 7550445 7550445*PED ARMODAFINIL - NUVIGIL N021875 001 7132570 7132570*PED 7297346 7297346*PED RE37516 RE37516*PED ARMODAFINIL - NUVIGIL N021875 002 7132570 7132570*PED 7297346 7297346*PED RE37516 RE37516*PED ARMODAFINIL - NUVIGIL N021875 003 7132570 7132570*PED 7297346 7297346*PED RE37516 RE37516*PED ARMODAFINIL - NUVIGIL N021875 004 7132570 7132570*PED 7297346 7297346*PED RE37516 RE37516*PED ARMODAFINIL - NUVIGIL N021875 005 7132570 7132570*PED 7297346 7297346*PED RE37516 RE37516*PED

Oct Apr Apr Oct

20, 20, 24, 24,

2014 2015 2022 2022

Feb Aug

16, 2014 27, 2011

Oct Apr

20, 2014 20, 2015

DS

DP

U-761

I-633 PED

Feb Aug

16, 2014 27, 2011

Oct Apr

20, 2014 20, 2015

DS

DP

U-761

I-633 PED

Feb Aug

16, 2014 27, 2011

Oct Apr

20, 2014 20, 2015

DS

DP

U-761

PED

Aug

27, 2011

Oct Apr

20, 2014 20, 2015

DS

DP

U-761

PED

Aug

27, 2011

Oct Apr Jul Jan Jul Jan

20, 20, 21, 21, 21, 21,

2014 2015 2024 2025 2024 2025

DS DS

DP DP DP

U-763 U-764

I-633 PED

Feb Aug

16, 2014 27, 2011

Dec Jun Nov May Oct Apr

18, 18, 29, 29, 06, 06,

2023 2024 2023 2024 2014 2015

DS

DP DP DP U-820

Dec Jun Nov May Oct Apr

18, 18, 29, 29, 06, 06,

2023 2024 2023 2024 2014 2015

DS

DP DP DP U-820

Dec Jun Nov May Oct Apr

18, 18, 29, 29, 06, 06,

2023 2024 2023 2024 2014 2015

DS

DP DP DP U-820

Dec Jun Nov May Oct Apr

18, 18, 29, 29, 06, 06,

2023 2024 2023 2024 2014 2015

DS

DP DP DP U-820

Dec Jun Nov May Oct Apr

18, 18, 29, 29, 06, 06,

2023 2024 2023 2024 2014 2015

DS

DP DP DP U-820

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 16 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-573 U-617 U-617 U-651 U-651

EXCLUSIVITY CODE(S)

ARSENIC TRIOXIDE - TRISENOX N021248 001 6723351 6855339 6861076 6884439 6982096

Nov Nov Nov Nov Nov

10, 10, 10, 10, 10,

2018 2018 2018 2018 2018

ARTEMETHER; LUMEFANTRINE - COARTEM N022268 001 5677331 Oct

14, 2014

DP

U-977

NCE ODE

Apr Apr

07, 2014 07, 2016

ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E - M.V.I.-12 (WITHOUT VITAMIN K) N008809 006 ODE Sep 09, 2011 ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE - MOVIPREP N021881 001 7169381 Sep 01, 2024 DS DP 7658914 Sep 01, 2024 DS DP ASENAPINE MALEATE - SAPHRIS N022117 001 5763476 7741358

Jun Apr

09, 2015 06, 2026

DS

DP DP

U-326 U-1064

I-629 I-628 NCE

Sep Sep Aug

03, 2013 03, 2013 13, 2014

ASENAPINE MALEATE - SAPHRIS N022117 002 5763476 7741358

Jun Apr

09, 2015 06, 2026

DS

DP DP

U-326 U-1064

I-629 I-628 NCE

Sep Sep Aug

03, 2013 03, 2013 13, 2014

ASPIRIN; DIPYRIDAMOLE - AGGRENOX N020884 001 6015577 Jan

18, 2017

U-302

ASPIRIN; PRAVASTATIN SODIUM - PRAVIGARD PAC (COPACKAGED) N021387 001 5622985 Apr 22, 2014 U-335 U-335 5622985*PED Oct 22, 2014 ASPIRIN; PRAVASTATIN SODIUM - PRAVIGARD PAC (COPACKAGED) U-335 N021387 002 5622985 Apr 22, 2014 U-335 5622985*PED Oct 22, 2014 ASPIRIN; PRAVASTATIN SODIUM - PRAVIGARD PAC (COPACKAGED) U-335 N021387 003 5622985 Apr 22, 2014 U-335 5622985*PED Oct 22, 2014 ASPIRIN; PRAVASTATIN SODIUM - PRAVIGARD PAC (COPACKAGED) U-335 N021387 004 5622985 Apr 22, 2014 U-335 5622985*PED Oct 22, 2014 ASPIRIN; PRAVASTATIN SODIUM - PRAVIGARD PAC (COPACKAGED) U-335 N021387 005 5622985 Apr 22, 2014 U-335 5622985*PED Oct 22, 2014 ASPIRIN; PRAVASTATIN SODIUM - PRAVIGARD PAC (COPACKAGED) U-335 N021387 006 5622985 Apr 22, 2014 5622985*PED Oct 22, 2014 U-335 ATAZANAVIR SULFATE - REYATAZ N021567 001 5849911 6087383 ATAZANAVIR SULFATE - REYATAZ N021567 002 5849911 6087383 ATAZANAVIR SULFATE - REYATAZ N021567 003 5849911 6087383

Jun Dec

20, 2017 21, 2018

DS DS

DP DP

U-167

D-130 D-116

Feb Sep

04, 2014 30, 2011

Jun Dec

20, 2017 21, 2018

DS DS

DP DP

U-167

D-130 D-116

Feb Sep

04, 2014 30, 2011

Jun Dec

20, 2017 21, 2018

DS DS

DP DP

U-167

D-130 D-116

Feb Sep

04, 2014 30, 2011

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 17 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DS DS DP DP U-167

EXCLUSIVITY CODE(S)
D-130 D-116

ATAZANAVIR SULFATE - REYATAZ N021567 004 5849911 6087383

Jun Dec

20, 2017 21, 2018

Feb Sep

04, 2014 30, 2011

ATOMOXETINE HYDROCHLORIDE - STRATTERA Nov 26, 2016 N021411 001 5658590 May 26, 2017 5658590*PED ATOMOXETINE HYDROCHLORIDE - STRATTERA Nov 26, 2016 N021411 002 5658590 May 26, 2017 5658590*PED ATOMOXETINE HYDROCHLORIDE - STRATTERA Nov 26, 2016 N021411 003 5658590 May 26, 2017 5658590*PED ATOMOXETINE HYDROCHLORIDE - STRATTERA Nov 26, 2016 N021411 004 5658590 May 26, 2017 5658590*PED ATOMOXETINE HYDROCHLORIDE - STRATTERA Nov 26, 2016 N021411 005 5658590 May 26, 2017 5658590*PED ATOMOXETINE HYDROCHLORIDE - STRATTERA Nov 26, 2016 N021411 006 5658590 May 26, 2017 5658590*PED ATOMOXETINE HYDROCHLORIDE - STRATTERA Nov 26, 2016 N021411 007 5658590 May 26, 2017 5658590*PED ATOMOXETINE HYDROCHLORIDE - STRATTERA N021411 008 5658590 Nov 26, 2016 5658590*PED May 26, 2017 ATORVASTATIN CALCIUM - ATORVASTATIN CALCIUM A076477 001 ATORVASTATIN CALCIUM - ATORVASTATIN CALCIUM A076477 002 ATORVASTATIN CALCIUM - ATORVASTATIN CALCIUM A076477 003 ATORVASTATIN CALCIUM - ATORVASTATIN CALCIUM A076477 004 ATORVASTATIN CALCIUM - LIPITOR N020702 001 5686104 5686104*PED 5969156 5969156*PED 6126971 6126971*PED ATORVASTATIN CALCIUM - LIPITOR N020702 002 5686104 5686104*PED 5969156 5969156*PED 6126971 6126971*PED ATORVASTATIN CALCIUM - LIPITOR N020702 003 5686104 5686104*PED 5969156 5969156*PED 6126971 6126971*PED

U-494 U-494

M-78

Jul

23, 2011

U-494 U-494

M-78

Jul

23, 2011

U-494 U-494

M-78

Jul

23, 2011

U-494 U-494

M-78

Jul

23, 2011

U-494 U-494

M-78

Jul

23, 2011

U-494 U-494

M-78

Jul

23, 2011

U-494 U-494

M-78

Jul

23, 2011

U-494 U-494

M-78

Jul

23, 2011

PC

May

28, 2012

PC

May

28, 2012

PC

May

28, 2012

PC DP DS DP U-213 U-213

May

28, 2012

Nov May Jul Jan Jan Jul

11, 11, 08, 08, 19, 19,

2014 2015 2016 2017 2013 2013

Nov May Jul Jan Jan Jul

11, 11, 08, 08, 19, 19,

2014 2015 2016 2017 2013 2013

DP DS DP

U-213 U-213

Nov May Jul Jan Jan Jul

11, 11, 08, 08, 19, 19,

2014 2015 2016 2017 2013 2013

DP DS DP

U-213 U-213

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 18 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DP DS DP U-213 U-213

EXCLUSIVITY CODE(S)

ATORVASTATIN CALCIUM - LIPITOR N020702 004 5686104 5686104*PED 5969156 5969156*PED 6126971 6126971*PED ATOVAQUONE - MEPRON N020500 001 6649659 6649659*PED

Nov May Jul Jan Jan Jul

11, 11, 08, 08, 19, 19,

2014 2015 2016 2017 2013 2013

Jul Jan

10, 2016 10, 2017 - MALARONE 25, 2013 25, 2014 25, 2013 25, 2014 25, 2013 25, 2014

DS

DP

U-69

ATOVAQUONE; PROGUANIL HYDROCHLORIDE N021078 001 5998449 Nov 5998449*PED May 6166046 Nov 6166046*PED May 6291488 Nov 6291488*PED May ATOVAQUONE; PROGUANIL HYDROCHLORIDE N021078 002 5998449 Nov 5998449*PED May 6166046 Nov 6166046*PED May 6291488 Nov 6291488*PED May

U-990 U-406 U-406

- MALARONE PEDIATRIC 25, 2013 U-990 25, 2014 25, 2013 25, 2014 U-406 25, 2013 25, 2014

AVOBENZONE; ECAMSULE; OCTOCRYLENE - ANTHELIOS SX N021502 001 5587150 Dec 24, 2013

DP

U-752

AVOBENZONE; ECAMSULE; OCTOCRYLENE; TITANIUM DIOXIDE - ANTHELIOS 40 N022009 002 AZELAIC ACID - FINACEA N021470 001 6534070 Nov 18, 2018

NP

Oct

29, 2012

AZELASTINE HYDROCHLORIDE - ASTEPRO N022203 001 8071073 Jun AZELASTINE HYDROCHLORIDE - ASTEPRO N022371 001 8071073 Jun AZILSARTAN KAMEDOXOMIL - EDARBI N200796 001 5583141 Dec 5736555 Jun 5958961 Jun 7157584 May 7572920 Jan AZILSARTAN KAMEDOXOMIL - EDARBI N200796 002 5583141 Dec 5736555 Jun 5958961 Jun 7157584 May 7572920 Jan

04, 2028

DP

NP

Oct

15, 2011

04, 2028

DP

NP

Aug

31, 2012

10, 25, 06, 22, 07,

2013 2012 2014 2025 2025

DS DS DS

DP DP DP DP

U-3 U-3 U-3 U-3

NCE

Feb

25, 2016

10, 25, 06, 22, 07,

2013 2012 2014 2025 2025

DS DS DS

DP DP DP DP

U-3 U-3 U-3 U-3

NCE

Feb

25, 2016

AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE - EDARBYCLOR N202331 001 AZITHROMYCIN - AZASITE N050810 001 6159458 6239113 6569443 6861411 7056893 AZITHROMYCIN - ZITHROMAX N050693 001 6268489

NCE NC DP DP DP U-709 U-709 U-709 U-709 U-709

Feb Dec

25, 2016 20, 2014

Nov Mar Mar Nov Mar

04, 31, 31, 25, 31,

2017 2019 2019 2018 2019

Jul

31, 2018

DS

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 19 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DS

EXCLUSIVITY CODE(S)

AZITHROMYCIN - ZITHROMAX N050710 001 6268489 AZITHROMYCIN - ZITHROMAX N050710 002 6268489 AZITHROMYCIN - ZITHROMAX N050711 001 6268489 AZITHROMYCIN - ZITHROMAX N050730 001 6268489 AZITHROMYCIN - ZITHROMAX N050733 001 6268489 AZITHROMYCIN - ZITHROMAX N050784 001 6268489 AZITHROMYCIN - ZMAX N050797 001 6068859 6268489 6984403 7887844 AZTREONAM - CAYSTON N050814 001 7208141 7214364 7427633 BACLOFEN - KEMSTRO N021589 001 6024981 6221392 BACLOFEN - KEMSTRO N021589 002 6024981 6221392 BALSALAZIDE DISODIUM - COLAZAL N020610 001 7452872 7452872*PED 7625884 7625884*PED

Jul

31, 2018

Jul

31, 2018

DS

Jul

31, 2018

DS

Jul

31, 2018

DS

Jul

31, 2018

DS

Jul

31, 2018

DS

May Jul Feb Feb

30, 31, 14, 14,

2017 2018 2024 2024

DP DS DP DP U-282

Dec Dec Dec

20, 2021 20, 2021 20, 2021

DP DP DP

U-1031 U-1031

ODE

Feb

22, 2017

Apr Apr

09, 2018 09, 2018

DP DP

Apr Apr

09, 2018 09, 2018

DP DP

Aug Feb Aug Feb

24, 24, 24, 24,

2026 2027 2026 2027

U-141 U-141

ODE PED

Dec Jun

20, 2013 20, 2014

BECLOMETHASONE DIPROPIONATE - QVAR 40 N020911 002 5605674 Feb 25, 2014 5683677 Nov 04, 2014 5776432 Jul 07, 2015 BECLOMETHASONE DIPROPIONATE - QVAR 80 N020911 001 5605674 Feb 25, 2014 5683677 Nov 04, 2014 5776432 Jul 07, 2015 BENDAMUSTINE HYDROCHLORIDE - TREANDA N022249 001

I-580 NCE ODE

Oct Mar Mar

31, 2011 20, 2013 20, 2015

BENDAMUSTINE HYDROCHLORIDE - TREANDA N022249 002

I-580 NCE ODE DP DP U-124

Oct Mar Mar

31, 2011 20, 2013 20, 2015

BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE - ACANYA N050819 001 5733886 Mar 31, 2015 6117843 Feb 18, 2012 BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE - DUAC N050741 001 5466446 Feb 16, 2014

DS

DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 20 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-970 U-970 U-970 U-970

EXCLUSIVITY CODE(S)
NCE

BENZYL ALCOHOL - ULESFIA N022129 001 5858383 6139859 6793931 7294342

Aug Aug Jul May

11, 11, 11, 19,

2017 2017 2022 2024

Apr

09, 2014

DP

BEPOTASTINE BESILATE - BEPREVE N022288 001 6780877 Dec

25, 2017

DS

DP

NCE

Sep

08, 2014

BESIFLOXACIN HYDROCHLORIDE - BESIVANCE N022308 001 5447926 Sep 05, 2012 Jun 29, 2021 6685958 Mar 31, 2019 6699492

DS

DP DP DP

U-80 U-80 U-80

NCE

May

28, 2014

BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE DS N021852 001 5763426 Jun 09, 2015 6753013 Jan 27, 2020 6753013 Jan 27, 2020 DS RE39706 Jun 09, 2015 BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE N022185 001 6753013 Jan 27, 2020 6753013 Jan 27, 2020 6787529 Jan 27, 2020 6787529 Jan 27, 2020 DS RE39706 Jun 09, 2015 BETAMETHASONE VALERATE - LUXIQ N020934 001 6126920 Mar 7078058 May

TACLONEX DP DP U-88 DP U-193 DP TACLONEX SCALP DP U-88 DP U-193 DP U-193 DP U-88 DP

01, 2016 24, 2017

U-484
DP

BETAXOLOL HYDROCHLORIDE; PILOCARPINE HYDROCHLORIDE - BETOPTIC PILO N020619 001 5635172 Jun 03, 2014 U-191 BEXAROTENE - TARGRETIN N021055 001 5780676 5962731 6043279 6320074 7655699 BEXAROTENE - TARGRETIN N021056 001 5780676 5962731 6043279 6320074 7655699 BICALUTAMIDE - CASODEX N020498 001 BIMATOPROST - LATISSE N022369 001 6403649 7351404 7388029 8017655 8038988 BIMATOPROST - LUMIGAN N021275 001 5688819 6403649 8017655 BIMATOPROST - LUMIGAN N022184 001 5688819 6403649 7851504 8017655

Jul Oct Apr Apr Apr

14, 05, 22, 22, 22,

2015 2016 2012 2012 2012

DS DS

DP

U-509 U-475 U-509 U-509 U-509

Jul Oct Apr Apr Apr

14, 05, 22, 22, 22,

2015 2016 2012 2012 2012

U-510 U-510 U-510 U-510

DS DS

DP

M-81 PED Sep May Jan Nov Aug 21, 25, 21, 27, 25, 2012 2024 2022 2012 2023 DS U-939 U-938 DS DS DP DP U-1208

Dec Jun

19, 2011 19, 2012

NP

Dec

24, 2011

Aug Sep Nov

19, 2014 21, 2012 27, 2012

DS DS

DP DP

U-446 U-446

Aug Sep Jun Nov

19, 21, 13, 27,

2014 2012 2027 2012

DS DS DS

U-1081 U-1081 DP DP

NP

Aug

31, 2013

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 21 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-837

EXCLUSIVITY CODE(S)
NP

BISACODYL - HALFLYTELY N021551 003 7291324

Oct

22, 2022

Jul

16, 2013

BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE - HALFLYTELY N021551 002 7291324 Oct 22, 2022 U-837 BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE - PYLERA N050786 001 6350468 Dec 14, 2018 U-932 U-956 6350468 Dec 14, 2018 BIVALIRUDIN - ANGIOMAX N020873 001 5196404 5196404*PED 7582727 7582727*PED 7598343 7598343*PED BOCEPREVIR - VICTRELIS N202258 001 7012066 7772178 BORTEZOMIB - VELCADE N021602 001 5780454 6083903 6297217 6297217 6297217 6617317 6713446 6747150 6958319 7119080 BOSENTAN - TRACLEER N021290 001 5292740 BOSENTAN - TRACLEER N021290 002 5292740

Aug Feb Jul Jan Jul Jan

13, 13, 27, 27, 27, 27,

2012 2013 2028 2029 2028 2029

DS

DP DP DP

U-1040

Feb Nov

22, 2022 11, 2027

DS

DP DP

U-1128 U-1128

NCE

May

13, 2016

May Oct Oct Oct Oct Oct Jan Oct Jan Oct

03, 28, 28, 28, 28, 28, 25, 28, 25, 28,

2017 2014 2014 2014 2014 2014 2022 2014 2022 2014

DP DP

ODE U-515 U-515 U-885 U-884

Mar

25, 2012

DS

DP DP DP DP DP

Nov

20, 2015

I-607

Aug

07, 2012

Nov

20, 2015

I-607

Aug

07, 2012

BRIMONIDINE TARTRATE - ALPHAGAN P N021262 001 5424078 Jun 5424078*PED Dec 6562873 Jul 6562873*PED Jan 6627210 Jul 6627210*PED Jan 6641834 Jul 6641834*PED Jan 6673337 Jul 6673337*PED Jan BRIMONIDINE TARTRATE - ALPHAGAN P N021770 001 5424078 Jun 5424078*PED Dec 6562873 Jul 6562873*PED Jan 6627210 Jul 6627210*PED Jan 6641834 Jul 6641834*PED Jan 6673337 Jul 6673337*PED Jan

13, 13, 10, 10, 18, 18, 28, 28, 26, 26,

2012 2012 2021 2022 2021 2022 2021 2022 2021 2022

DP DP DP

13, 13, 10, 10, 18, 18, 28, 28, 26, 26,

2012 2012 2021 2022 2021 2022 2021 2022 2021 2022

DP DP DP DP DP

BRIMONIDINE TARTRATE - BRIMONIDINE TARTRATE N021764 001 7265117 Aug 19, 2025

DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 22 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE
COMBIGAN 2022 2022 2023 DS 2022

APPL/PROD NO

PATENT NO

PATENT CODES
U-849 U-849 DP DP U-1024

PATENT DELIST REQUESTED

EXCLUSIVITY CODE(S)

EXCLUSIVITY EXPIRATION DATE

BRIMONIDINE TARTRATE; TIMOLOL MALEATE N021398 001 7030149 Apr 19, 7320976 Apr 19, Jan 19, 7323463 Apr 19, 7642258 BRINZOLAMIDE - AZOPT N020816 001 5378703 5378703*PED 5461081 5461081*PED BROMFENAC SODIUM - BROMDAY N021664 002 BROMOCRIPTINE MESYLATE - CYCLOSET N020866 001 5468755 Nov 5679685 Oct 5716957 Feb 5756513 Nov 5866584 Nov 7888310 Jul BUDESONIDE - ENTOCORT EC N021324 001 5643602 5643602*PED

Apr Oct Oct Apr

01, 01, 24, 24,

2012 2012 2012 2013

DS

DP DP

U-224 U-225

NP 21, 21, 10, 21, 21, 25, 2012 2014 2015 2012 2012 2023 U-976 DP U-976 U-976 U-976 U-976

Oct

16, 2013

NP

May

05, 2012

Jul Jan

01, 2014 01, 2015

U-655 DP

BUDESONIDE - PULMICORT FLEXHALER N021949 001 6027714 Jan 6142145 May Jan 6287540 Mar 7143764 BUDESONIDE - PULMICORT FLEXHALER N021949 002 6027714 Jan 6142145 May Jan 6287540 Mar 7143764 BUDESONIDE - PULMICORT RESPULES N020929 001 6598603 Dec 6598603*PED Jun 6899099 Dec 6899099*PED Jun 7524834 Nov 7524834*PED May BUDESONIDE - PULMICORT RESPULES N020929 002 6598603 Dec 6598603*PED Jun 6899099 Dec 6899099*PED Jun 7524834 Nov 7524834*PED May BUDESONIDE - PULMICORT RESPULES N020929 003 6598603 Dec 6598603*PED Jun 6899099 Dec 6899099*PED Jun 7524834 Nov 7524834*PED May BUDESONIDE - RHINOCORT N020746 001 6291445 6291445*PED 6686346 6686346*PED 6986904 6986904*PED

09, 08, 09, 13,

2018 2018 2018 2018

DP DP DP DP

U-787

09, 08, 09, 13,

2018 2018 2018 2018

DP DP DP DP

U-787

23, 23, 23, 23, 11, 11,

2018 2019 2018 2019 2018 2019

U-529 U-529 DP U-966

23, 23, 23, 23, 11, 11,

2018 2019 2018 2019 2018 2019

U-529 U-529 DP U-966

23, 23, 23, 23, 11, 11,

2018 2019 2018 2019 2018 2019

U-529 U-529 DP U-966

Apr Oct Apr Oct Apr Oct

29, 29, 29, 29, 29, 29,

2017 2017 2017 2017 2017 2017

Y DP DP U-557 U-699 Y Y

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 23 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)

BUDESONIDE - RHINOCORT N020746 002 6291445 6291445*PED 6686346 6686346*PED 6986904 6986904*PED

Apr Oct Apr Oct Apr Oct

29, 29, 29, 29, 29, 29,

2017 2017 2017 2017 2017 2017

DP DP

U-557 U-699

BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE - SYMBICORT DP N021929 001 5349945 Nov 12, 2011 5674860 Oct 07, 2014 DP DP 5972919 Dec 17, 2012 DP 6123924 Sep 26, 2017 DP 6641800 Sep 23, 2012 DP 7367333 Nov 11, 2018 7587988 Apr 10, 2026 DP DP 7759328 Jan 29, 2023 DP 7967011 Aug 11, 2021 BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE - SYMBICORT DP N021929 002 5349945 Nov 12, 2011 DP 5674860 Oct 07, 2014 DP 5972919 Dec 17, 2012 DP 6123924 Sep 26, 2017 6641800 Sep 23, 2012 DP DP 7367333 Nov 11, 2018 DP 7587988 Apr 10, 2026 DP 7759328 Jan 29, 2023 7897646 Sep 09, 2018 7967011 Aug 11, 2021 DP BUPIVACAINE - EXPAREL N022496 001 BUPIVACAINE - EXPAREL N022496 002 BUPRENORPHINE - BUTRANS N021306 001 6264980 6344211 RE41408 RE41489 RE41571 BUPRENORPHINE - BUTRANS N021306 002 6264980 6344211 RE41408 RE41489 RE41571 BUPRENORPHINE - BUTRANS N021306 003 6264980 6344211 RE41408 RE41489 RE41571

I-582 U-1075 U-1075

Feb

27, 2012

U-1073

I-582 U-1075 U-1075

Feb

27, 2012

U-1073 U-1118

NP

Oct

28, 2014

NP Dec Dec Sep Sep Sep 18, 18, 29, 29, 29, 2015 2015 2017 2017 2017 DP U-1072 U-1072 U-1072 U-1072

Oct

28, 2014

NDF

Jun

30, 2013

Dec Dec Sep Sep Sep

18, 18, 29, 29, 29,

2015 2015 2017 2017 2017

DP U-1072 U-1072 U-1072 U-1072

NDF

Jun

30, 2013

Dec Dec Sep Sep Sep

18, 18, 29, 29, 29,

2015 2015 2017 2017 2017

DP U-1072 U-1072 U-1072 U-1072

NDF

Jun

30, 2013

BUPRENORPHINE; NALOXONE - SUBOXONE Sep N022410 001 8017150 BUPRENORPHINE; NALOXONE - SUBOXONE Sep N022410 002 8017150

10, 2023

DP

NDF

Aug

30, 2013

10, 2023

DP

NDF

Aug

30, 2013

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 24 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DP U-997 DP DP DP DP DP DP

EXCLUSIVITY CODE(S)

BUPROPION HYDROBROMIDE - APLENZIN N022108 001 7241805 Jun 7569610 Jun 7572935 Jun 7585897 Jun 7645802 Jun 7649019 Jun 7662407 Jun 7671094 Jun BUPROPION HYDROBROMIDE - APLENZIN N022108 002 7241805 Jun 7569610 Jun 7572935 Jun 7585897 Jun 7645802 Jun 7649019 Jun 7662407 Jun 7671094 Jun BUPROPION HYDROBROMIDE - APLENZIN N022108 003 7241805 Jun 7569610 Jun 7572935 Jun 7585897 Jun 7645802 Jun 7649019 Jun 7662407 Jun 7671094 Jun

27, 27, 27, 27, 27, 27, 27, 27,

2026 2026 2026 2026 2026 2026 2026 2026

27, 27, 27, 27, 27, 27, 27, 27,

2026 2026 2026 2026 2026 2026 2026 2026

DP U-997 DP DP DP DP DP DP

27, 27, 27, 27, 27, 27, 27, 27,

2026 2026 2026 2026 2026 2026 2026 2026

DP U-997 DP DP DP DP DP DP

BUPROPION HYDROCHLORIDE - FORFIVO XL N022497 001 7674479 Jun 25, 2027 BUPROPION HYDROCHLORIDE - WELLBUTRIN SR N020358 001 5358970 Aug 12, 2013 Aug 12, 2013 5427798 Aug 12, 2013 5731000 Aug 12, 2013 5763493 BUPROPION HYDROCHLORIDE - WELLBUTRIN SR Aug 12, 2013 N020358 002 5358970 Aug 12, 2013 5427798 Aug 12, 2013 5731000 Aug 12, 2013 5763493 BUPROPION HYDROCHLORIDE - WELLBUTRIN SR Aug 12, 2013 N020358 003 5358970 Aug 12, 2013 5427798 Aug 12, 2013 5731000 Aug 12, 2013 5763493 BUPROPION HYDROCHLORIDE - WELLBUTRIN SR Aug 12, 2013 N020358 004 5358970 Aug 12, 2013 5427798 Aug 12, 2013 5731000 Aug 12, 2013 5763493 BUPROPION HYDROCHLORIDE - WELLBUTRIN XL N021515 001 6096341 Oct 30, 2018 BUPROPION HYDROCHLORIDE - WELLBUTRIN XL N021515 002 6096341 Oct 30, 2018 BUPROPION HYDROCHLORIDE - ZYBAN Aug N020711 002 5358970 Aug 5427798 Aug 5731000 Aug 5763493

DP

12, 12, 12, 12,

2013 2013 2013 2013

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 25 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)

BUPROPION HYDROCHLORIDE - ZYBAN Aug N020711 003 5358970 Aug 5427798 Aug 5731000 Aug 5763493 BUSULFAN - BUSULFEX N020954 001 5430057 5430057*PED 5559148 5559148*PED

12, 12, 12, 12,

2013 2013 2013 2013

Sep Mar Sep Mar

30, 30, 30, 30,

2013 2014 2013 2014

U-263 U-263 U-264 U-264

BUTOCONAZOLE NITRATE - GYNAZOLE-1 N019881 001 5993856 Nov CABAZITAXEL - JEVTANA KIT N201023 001 5438072 5698582 5847170 6331635 6372780 6387946 7241907 CALCIPOTRIENE - DOVONEX N020554 001 5763426 RE39706 CALCIPOTRIENE - DOVONEX N020611 001 5763426 RE39706 CALCIPOTRIENE - SORILUX N022563 001 CALCITONIN SALMON - MIACALCIN N020313 002 5733569 5759565

17, 2017

DP

U-457

Nov Jul Mar Mar Mar Mar Dec

22, 03, 26, 26, 26, 26, 10,

2013 2012 2016 2016 2016 2016 2025

DS DS

DP DP DP DP U-1067 U-1067

NCE

Jun

17, 2015

DS

Jun Jun

09, 2015 09, 2015

DS DS

DP DP

Jun Jun

09, 2015 09, 2015

DS DS

DP DP

NDF Mar Mar 31, 2015 31, 2015 U-227

Oct

06, 2013

CALCITONIN SALMON RECOMBINANT - FORTICAL N021406 001 6440392 Feb 02, 2021 RE40812 Feb 02, 2021 CALCITRIOL - CALCIJEX N018874 001 6051567 6051567*PED 6265392 6265392*PED 6274169 6274169*PED CALCITRIOL - CALCIJEX N018874 002 6051567 6051567*PED 6265392 6265392*PED 6274169 6274169*PED CALCITRIOL - VECTICAL N022087 001 CALCIUM ACETATE - PHOSLO N021160 002 6576665

DP DP

U-227

Aug Feb Aug Feb Aug Feb

02, 02, 02, 02, 02, 02,

2019 2020 2019 2020 2019 2020

Aug Feb Aug Feb Aug Feb

02, 02, 02, 02, 02, 02,

2019 2020 2019 2020 2019 2020

NDF Apr 03, 2021

Jan

23, 2012

CALCIUM ACETATE - PHOSLO GELCAPS Apr N021160 003 6576665

03, 2021

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 26 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)

CALCIUM CARBONATE; FAMOTIDINE; N020958 001 5229137 5229137*PED 5989588 5989588*PED 6814978 6814978*PED CALCIUM CARBONATE; RISEDRONATE N021823 001 5583122 5583122*PED 5994329 5994329*PED 6015801 6015801*PED 6096342 6096342*PED 6165513 6165513*PED 6432932 6432932*PED 6465443 6465443*PED

MAGNESIUM HYDROXIDE - PEPCID COMPLETE May 16, 2012 U-349 Nov 16, 2012 U-349 Sep 30, 2015 U-349 Mar 30, 2016 DP Aug 26, 2021 Feb 26, 2022 SODIUM Dec 10, Jun 10, Jul 17, Jan 17, Jul 17, Jan 17, Nov 21, May 21, Jun 10, Dec 10, Jul 17, Jan 17, Aug 14, Feb 14, ACTONEL WITH CALCIUM (COPACKAGED) DS DP U-353 2013 2014 U-353 2018 2019 U-353 2018 2019 DP 2011 2012 DP 2018 2018 U-595 2018 2019 2018 DP 2019

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; OXIGLUTATIONE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE - NAVSTEL Apr 25, 2012 DP U-891 N022193 001 5409904 NP Jul 24, 2011 DP Apr 25, 2012 5578578 DP U-891 Nov 29, 2021 7084130 CANDESARTAN CILEXETIL - ATACAND N020838 001 5196444 Jun 5196444 Jun 5196444*PED Dec 5534534 Jul 5534534*PED Jan 5705517*PED Oct 7538133*PED Oct CANDESARTAN CILEXETIL - ATACAND N020838 002 5196444 Jun 5196444 Jun 5196444*PED Dec 5534534 Jul 5534534*PED Jan 5705517*PED Oct 7538133*PED Oct CANDESARTAN CILEXETIL - ATACAND N020838 003 5196444 Jun 5196444 Jun 5196444*PED Dec 5534534 Jul 5534534*PED Jan 5705517*PED Oct 7538133*PED Oct CANDESARTAN CILEXETIL - ATACAND N020838 004 5196444 Jun 5196444 Jun 5196444*PED Dec 5534534 Jul 5534534*PED Jan 5705517*PED Oct 7538133*PED Oct

04, 04, 04, 09, 09, 18, 18,

2012 2012 2012 2013 2014 2011 2011

DS DS

DP DP DP

U-660 U-3

04, 04, 04, 09, 09, 18, 18,

2012 2012 2012 2013 2014 2011 2011

DS DS

DP DP DP

U-3 U-660

04, 04, 04, 09, 09, 18, 18,

2012 2012 2012 2013 2014 2011 2011

DS DS

DP DP DP

U-3 U-660

04, 04, 04, 09, 09, 18, 18,

2012 2012 2012 2013 2014 2011 2011

DS DS

DP DP DP

U-660 U-3

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 27 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)

CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE - ATACAND HCT DS DP U-3 N021093 001 5196444 Jun 04, 2012 5196444*PED Dec 04, 2012 DP 5534534 Jul 09, 2013 5534534*PED Jan 09, 2014 5705517*PED Oct 18, 2011 DP U-3 5721263 Feb 24, 2015 DP U-3 5958961 Jun 06, 2014 7538133*PED Oct 18, 2011 CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE - ATACAND HCT DS DP U-3 N021093 002 5196444 Jun 04, 2012 5196444*PED Dec 04, 2012 DP 5534534 Jul 09, 2013 5534534*PED Jan 09, 2014 5705517*PED Oct 18, 2011 DP U-3 5721263 Feb 24, 2015 DP U-3 5958961 Jun 06, 2014 7538133*PED Oct 18, 2011 CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE - ATACAND HCT DS DP U-3 N021093 003 5196444 Jun 04, 2012 5196444*PED Dec 04, 2012 DP 5534534 Jul 09, 2013 5534534*PED Jan 09, 2014 5705517*PED Oct 18, 2011 DP U-3 5721263 Feb 24, 2015 DP U-3 5958961 Jun 06, 2014 7538133*PED Oct 18, 2011 CAPECITABINE - XELODA N020896 001 5472949 CAPECITABINE - XELODA N020896 002 5472949 CAPSAICIN - QUTENZA N022395 001 6239180 CARBAMAZEPINE - CARBAMAZEPINE A076697 003 CARBAMAZEPINE - CARBATROL N020712 001 5326570 5912013 CARBAMAZEPINE - CARBATROL N020712 002 5326570 5912013 CARBAMAZEPINE - CARBATROL N020712 003 5326570 5912013 CARBAMAZEPINE - EQUETRO N021710 001 5326570 5912013 6977253 CARBAMAZEPINE - EQUETRO N021710 002 5326570 5912013 6977253 CARBAMAZEPINE - EQUETRO N021710 003 5326570 5912013 6977253

Dec

14, 2013

U-271

Dec

14, 2013

U-271

Nov

06, 2016

DP

NCE ODE

Nov Nov

16, 2014 16, 2016

PC Jul Jun 23, 2011 15, 2016 U-215 U-277

Nov

16, 2011

Jul Jun

23, 2011 15, 2016

U-215 U-277

Jul Jun

23, 2011 15, 2016

U-215 U-277

Jul Jun May

23, 2011 15, 2016 19, 2024

DP DP

U-627 U-693

Jul Jun May

23, 2011 15, 2016 19, 2024

DP DP

U-627 U-693

Jul Jun May

23, 2011 15, 2016 19, 2024

DP DP

U-627 U-693

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 28 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DS DP DP U-219

EXCLUSIVITY CODE(S)

CARBIDOPA; ENTACAPONE; LEVODOPA - STALEVO 100 N021485 002 5446194 Oct 19, 2013 6500867 Jun 29, 2020 6797732 Jun 29, 2020 CARBIDOPA; ENTACAPONE; LEVODOPA - STALEVO 125 N021485 006 5446194 Oct 19, 2013 6500867 Jun 29, 2020 6797732 Jun 29, 2020 CARBIDOPA; ENTACAPONE; LEVODOPA - STALEVO 150 N021485 003 5446194 Oct 19, 2013 6500867 Jun 29, 2020 6797732 Jun 29, 2020 CARBIDOPA; ENTACAPONE; LEVODOPA - STALEVO 200 N021485 004 5446194 Oct 19, 2013 6500867 Jun 29, 2020 6797732 Jun 29, 2020 CARBIDOPA; ENTACAPONE; LEVODOPA - STALEVO 50 N021485 001 5446194 Oct 19, 2013 6500867 Jun 29, 2020 6797732 Jun 29, 2020 CARBIDOPA; ENTACAPONE; LEVODOPA - STALEVO 75 N021485 005 5446194 Oct 19, 2013 6500867 Jun 29, 2020 6797732 Jun 29, 2020 CARGLUMIC ACID - CARBAGLU N022562 001 CARVEDILOL - COREG N020297 001 RE40000 RE40000*PED CARVEDILOL - COREG N020297 002 RE40000 RE40000*PED CARVEDILOL - COREG N020297 003 RE40000 RE40000*PED CARVEDILOL - COREG N020297 004 RE40000 RE40000*PED

DS DP DP U-219

DS DP DP U-219

DS DP DP U-219

DS DP DP U-219

DS DP DP U-219

NCE ODE Jun Dec 07, 2015 07, 2015 U-233

Mar Mar

18, 2015 18, 2017

Jun Dec

07, 2015 07, 2015

U-233

Jun Dec

07, 2015 07, 2015

U-233

Jun Dec

07, 2015 07, 2015

U-233

CARVEDILOL PHOSPHATE - COREG CR Feb N022012 001 5902821 Feb 5902821 Aug 5902821*PED Oct 6022562 Apr 6022562*PED Jun 7268156 Jun 7268156 Dec 7268156*PED Jun RE40000 Dec RE40000*PED

07, 07, 07, 17, 17, 27, 27, 27, 07, 07,

2016 2016 2016 2015 2016 2023 2023 2023 2015 2015

U-313 U-777 DP DS DS DP DP U-313 U-3 U-777

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 29 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-313 U-777 DP DS DS DP DP U-3 U-313 U-777

EXCLUSIVITY CODE(S)

CARVEDILOL PHOSPHATE - COREG CR Feb N022012 002 5902821 Feb 5902821 Aug 5902821*PED Oct 6022562 Apr 6022562*PED Jun 7268156 Jun 7268156 Dec 7268156*PED Jun RE40000 Dec RE40000*PED CARVEDILOL PHOSPHATE - COREG CR Feb N022012 003 5902821 Feb 5902821 Aug 5902821*PED Oct 6022562 Apr 6022562*PED Jun 7268156 Jun 7268156 Dec 7268156*PED Jun RE40000 Dec RE40000*PED CARVEDILOL PHOSPHATE - COREG CR Feb N022012 004 5902821 Feb 5902821 Aug 5902821*PED Oct 6022562 Apr 6022562*PED Jun 7268156 Jun 7268156 Dec 7268156*PED Jun RE40000 Dec RE40000*PED CASPOFUNGIN ACETATE - CANCIDAS N021227 001 5378804 5378804*PED 5514650 5514650*PED 5792746 5792746*PED 5952300 5952300*PED 6136783 6136783*PED CASPOFUNGIN ACETATE - CANCIDAS N021227 002 5378804 5378804*PED 5514650 5514650*PED 5792746 5792746*PED 5952300 5952300*PED 6136783 6136783*PED CEFDINIR - OMNICEF N050739 001 4935507 CEFDINIR - OMNICEF N050749 001 4935507 CEFDINIR - OMNICEF N050749 002 4935507

07, 07, 07, 17, 17, 27, 27, 27, 07, 07,

2016 2016 2016 2015 2016 2023 2023 2023 2015 2015

07, 07, 07, 17, 17, 27, 27, 27, 07, 07,

2016 2016 2016 2015 2016 2023 2023 2023 2015 2015

U-777 U-313 DP DS DS DP DP U-313 U-3 U-777

07, 07, 07, 17, 17, 27, 27, 27, 07, 07,

2016 2016 2016 2015 2016 2023 2023 2023 2015 2015

U-777 U-313 DP DS DS DP DP U-313 U-3 U-777

Mar Sep Jan Jul Mar Sep Mar Sep Mar Sep

16, 16, 26, 26, 16, 16, 28, 28, 28, 28,

2013 2013 2015 2015 2013 2013 2017 2017 2017 2017

DS DP DS DP DP U-607 U-607 U-607

Mar Sep Jan Jul Mar Sep Mar Sep Mar Sep

16, 16, 26, 26, 16, 16, 28, 28, 28, 28,

2013 2013 2015 2015 2013 2013 2017 2017 2017 2017

DS DP DS DP DP U-607 U-607 U-607

Dec

04, 2011

DS

Dec

04, 2011

DS

Dec

04, 2011

DS

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 30 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)

CEFDITOREN PIVOXIL - SPECTRACEF N021222 001 5958915 Oct CEFDITOREN PIVOXIL - SPECTRACEF N021222 002 5958915 Oct CEFTAROLINE FOSAMIL - TEFLARO N200327 001 6417175 6906055 7419973 CEFTAROLINE FOSAMIL - TEFLARO N200327 002 6417175 6906055 7419973 CEFTIBUTEN DIHYDRATE - CEDAX N050685 002 5599557 CEFTIBUTEN DIHYDRATE - CEDAX N050686 001 5599557 5599557 CEFTIBUTEN DIHYDRATE - CEDAX N050686 002 5599557 5599557 CELECOXIB - CELEBREX N020998 001 5466823 5466823*PED 5563165 5563165*PED 5760068 5760068*PED CELECOXIB - CELEBREX N020998 002 5466823 5466823*PED 5563165 5563165*PED 5760068 5760068*PED CELECOXIB - CELEBREX N020998 003 5466823 5466823*PED 5563165 5563165*PED 5760068 5760068*PED CELECOXIB - CELEBREX N020998 004 5466823 5466823*PED 5563165 5563165*PED 5760068 5760068*PED CERIVASTATIN SODIUM - BAYCOL N020740 001 5177080 CERIVASTATIN SODIUM - BAYCOL N020740 002 5177080 CERIVASTATIN SODIUM - BAYCOL N020740 003 5177080 CERIVASTATIN SODIUM - BAYCOL N020740 004 5177080

14, 2016

14, 2016

DP

Dec Dec Dec

17, 2018 15, 2021 15, 2021

DS DS

DP DP DP

U-282

NCE

Oct

29, 2015

Dec Dec Dec

17, 2018 15, 2021 15, 2021

DS DS

DP DP DP

U-282

NCE

Oct

29, 2015

Apr

30, 2013

DP

Feb Feb

04, 2014 04, 2014

DP DP

U-282 U-578

Feb Feb

04, 2014 04, 2014

DP DP

U-578 U-282

Nov May Nov May Jun Dec

30, 30, 30, 30, 02, 02,

2013 2014 2013 2014 2015 2015

DS DP U-672

Nov May Nov May Jun Dec

30, 30, 30, 30, 02, 02,

2013 2014 2013 2014 2015 2015

DS DP U-672

Nov May Nov May Jun Dec

30, 30, 30, 30, 02, 02,

2013 2014 2013 2014 2015 2015

DS DP U-672

Nov May Nov May Jun Dec

30, 30, 30, 30, 02, 02,

2013 2014 2013 2014 2015 2015

DS DP U-672

Nov

26, 2011

Nov

26, 2011

Nov

26, 2011

Nov

26, 2011

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 31 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)

CERIVASTATIN SODIUM - BAYCOL N020740 005 5177080

Nov

26, 2011

CETIRIZINE HYDROCHLORIDE - CHILDREN'S ZYRTEC ALLERGY DP N021621 003 6455533 Jul 02, 2018 CETIRIZINE HYDROCHLORIDE - CHILDREN'S ZYRTEC ALLERGY DP N021621 004 6455533 Jul 02, 2018

U-295

U-295

CETIRIZINE HYDROCHLORIDE - CHILDREN'S ZYRTEC HIVES RELIEF DP U-295 N021621 005 6455533 Jul 02, 2018 CETIRIZINE HYDROCHLORIDE - CHILDREN'S ZYRTEC HIVES RELIEF DP U-295 N021621 006 6455533 Jul 02, 2018 CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE - ZYRTEC-D 12 HOUR Jul 13, 2019 DP U-295 N021150 002 6469009 DP Apr 08, 2016 6489329 DP Jun 10, 2022 7014867 U-295 Jun 10, 2022 7226614 CETRORELIX - CETROTIDE N021197 001 6319192 6863891 7605121 CETRORELIX - CETROTIDE N021197 002 6319192 6863891 7605121

Apr Feb Feb

23, 2019 22, 2014 22, 2014

U-426 U-426 DP

Apr Feb Feb

23, 2019 22, 2014 22, 2014

U-426 U-426 DP

CEVIMELINE HYDROCHLORIDE - EVOXAC N020989 002 5340821 Jul

07, 2013

U-309

CHLORHEXIDINE GLUCONATE - CHLORHEXIDINE GLUCONATE N021669 001 7066916 Feb 17, 2024 7427574 Apr 25, 2026 May 12, 2023 7595021 Oct 02, 2027 7935093

U-737 DP DP DP U-1022 U-1022

CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - CHLORAPREP ONE-STEP Sep 30, 2016 DP N020832 001 5690958 DP Nov 10, 2020 6536975 CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - CHLORAPREP ONE-STEP Sep 30, 2016 DP N020832 004 5690958 DP Nov 10, 2020 6536975 CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - CHLORAPREP ONE-STEP N020832 006 5690958 Sep 30, 2016 DP DP 6991394 Jan 31, 2024 DP 7182536 Dec 30, 2023 CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - CHLORAPREP ONE-STEP FREPP Aug 25, 2015 DP N020832 003 5538353 DP Sep 30, 2016 5690958 DP Apr 22, 2017 5752363 Apr 22, 2017 DP 5772346 DP Nov 25, 2011 D386849 DP Aug 11, 2012 D396911 CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - CHLORAPREP ONE-STEP SEPP N021555 001 5690958 Sep 30, 2016 DP CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - CHLORAPREP WITH TINT N020832 002 5690958 Sep 30, 2016 DP 6729786 Mar 14, 2023 DP DP 6991393 Mar 14, 2023 DP 6991394 Jan 31, 2024 DP 7182536 Dec 30, 2023 DP 7241065 Mar 14, 2023

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 32 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)

CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - CHLORAPREP WITH TINT DP N020832 005 5690958 Sep 30, 2016 Nov 10, 2020 DP 6536975 DP Mar 14, 2023 6729786 DP Jan 31, 2024 6991393 DP Mar 14, 2023 7241065 CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - CHLORAPREP WITH TINT DP N020832 007 5690958 Sep 30, 2016 Nov 10, 2020 DP 6536975 Mar 14, 2023 DP 6729786 DP Mar 14, 2023 6991393 DP Mar 14, 2023 7241065 CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - CHLORASCRUB MAXI SWABSTICK N021524 003 D468424 Jan 07, 2017 CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE - ADVIL ALLERGY SINUS DP N021441 001 7863287 Feb 28, 2027 CHOLINE FENOFIBRATE - TRILIPIX N022224 001 7259186 Jan CHOLINE FENOFIBRATE - TRILIPIX N022224 002 7259186 Jan CHORIOGONADOTROPIN ALFA - OVIDREL N021149 001 5767251 Jun CHORIOGONADOTROPIN ALFA - OVIDREL N021149 002 5767251 Jun 6706681 Mar CICLESONIDE - ALVESCO N021658 002 5482934 5605674 5683677 5775321 6006745 6036942 6120752 6264923 CICLESONIDE - ALVESCO N021658 003 5482934 5605674 5683677 5775321 6006745 6036942 6120752 6264923 CICLESONIDE - OMNARIS N022004 001 5482934 6767901 6939559 7235247 CICLOPIROX - LOPROX N020519 001 7018656 7026337 CICLOPIROX - LOPROX N021159 001 7981909

07, 2025

DS

NP

Dec

15, 2011

07, 2025

DS

NP

Dec

15, 2011

16, 2015

16, 2015 16, 2021

DS DP

Oct Feb Nov Jul Dec Apr May May

24, 25, 04, 07, 28, 30, 13, 13,

2017 2014 2014 2015 2016 2013 2018 2018

DS

DP DP DP DP DP DP DP DP

U-1002

NCE

Oct

20, 2011

Oct Feb Nov Jul Dec Apr May May

24, 25, 04, 07, 28, 30, 13, 13,

2017 2014 2014 2015 2016 2013 2018 2018

DS

DP DP DP DP DP DP DP DP

U-1002

NCE

Oct

20, 2011

Oct Oct Apr Apr

24, 21, 21, 21,

2017 2020 2019 2019

DS

DP DP DP DP

U-557

NCE

Oct

20, 2011

Sep Nov

05, 2018 21, 2016

DP
U-714

Sep

16, 2017

U-1162

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 33 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DS DS DS DP

EXCLUSIVITY CODE(S)
I-634 M-101 ODE

CINACALCET HYDROCHLORIDE - SENSIPAR N021688 001 6011068 Mar 08, 2018 6031003 Dec 14, 2016 6211244 Oct 23, 2015 6313146 Dec 14, 2016 7829595 Sep 22, 2026 CINACALCET HYDROCHLORIDE - SENSIPAR N021688 002 6011068 Mar 08, 2018 6031003 Dec 14, 2016 6211244 Oct 23, 2015 6313146 Dec 14, 2016 7829595 Sep 22, 2026 CINACALCET HYDROCHLORIDE - SENSIPAR N021688 003 6011068 Mar 08, 2018 6031003 Dec 14, 2016 6211244 Oct 23, 2015 6313146 Dec 14, 2016 7829595 Sep 22, 2026 CIPROFLOXACIN - CIPRO N020780 001 5695784 5695784*PED 6136347 6136347*PED CIPROFLOXACIN - CIPRO N020780 002 5695784 5695784*PED 6136347 6136347*PED

DP DP
DP U-1098

U-559 U-560

Feb Feb Feb

25, 2014 25, 2014 25, 2018

DS DS DS

DP DP U-560 DP
DP U-1098

I-634 M-101 ODE

Feb Feb Feb

25, 2014 25, 2014 25, 2018

DS DS DS

DP DP DP
DP U-1098
U-559 U-560

I-634 M-101 ODE

Feb Feb Feb

25, 2014 25, 2014 25, 2018

Dec Jun Jan Jul

09, 09, 06, 06,

2014 2015 2013 2013

U-362

Dec Jun Jan Jul

09, 09, 06, 06,

2014 2015 2013 2013

U-362

CIPROFLOXACIN HYDROCHLORIDE - CETRAXAL N021918 001 CIPROFLOXACIN HYDROCHLORIDE - CIPRO N019537 001 5286754*PED Aug 15, 2011 CIPROFLOXACIN HYDROCHLORIDE - CIPRO N019537 002 5286754*PED Aug 15, 2011 CIPROFLOXACIN HYDROCHLORIDE - CIPRO N019537 003 5286754*PED Aug 15, 2011 CIPROFLOXACIN HYDROCHLORIDE - CIPRO N019537 004 5286754*PED Aug 15, 2011 CIPROFLOXACIN HYDROCHLORIDE - PROQUIN XR N021744 001 5972389 Sep 19, 2016 6340475 Sep 19, 2016 6488962 Jun 20, 2020 6635280 Sep 19, 2016

NDF

May

01, 2012

DP DP DP DP

U-663 U-663 U-663

CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE - CIPRO HC U-646 N020805 001 5843930 Jun 06, 2015 DP 5965549 Jun 06, 2015 CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE - CIPRO XR DP N021473 001 7709022 Jun 23, 2021 7709022*PED Dec 23, 2021 CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE - CIPRO XR DP N021473 002 7709022 Jun 23, 2021 7709022*PED Dec 23, 2021 CIPROFLOXACIN; DEXAMETHASONE - CIPRODEX N021537 001 6284804 Aug 10, 2020 6359016 Aug 10, 2020

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 34 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)

CISAPRIDE MONOHYDRATE - PROPULSID QUICKSOLV N020767 001 5648093 Jul 15, 2014 CISATRACURIUM BESYLATE - NIMBEX Sep N020551 001 5453510

26, 2012

U-127

CISATRACURIUM BESYLATE - NIMBEX PRESERVATIVE FREE N020551 002 5453510 Sep 26, 2012 CISATRACURIUM BESYLATE - NIMBEX PRESERVATIVE FREE N020551 003 5453510 Sep 26, 2012 CLARITHROMYCIN - BIAXIN XL N050775 001 6010718 6551616

U-127

U-127

Apr Jul

11, 2017 15, 2017

DP

U-924 U-924

CLEVIDIPINE BUTYRATE - CLEVIPREX N022156 001 5739152 Apr 5856346 Jan CLEVIDIPINE BUTYRATE - CLEVIPREX N022156 002 5739152 Apr 5856346 Jan CLINDAMYCIN PHOSPHATE - CLEOCIN N050767 001 6495157 Jul CLINDAMYCIN PHOSPHATE - CLINDAGEL N050782 001 6387383 Aug CLINDAMYCIN PHOSPHATE - CLINDESSE N050793 001 5993856 Nov 6899890 Apr CLINDAMYCIN PHOSPHATE - EVOCLIN N050801 001 7141237 Jan 7374747 Aug

14, 2015 05, 2016

DS

DP DP

U-893 U-893

NCE

Aug

01, 2013

14, 2015 05, 2016

DS

DP DP

U-893 U-893

NCE

Aug

01, 2013

20, 2020

DP

03, 2020

DP

U-818

17, 2017 27, 2023

DP DP

U-137 U-137

23, 2024 09, 2026

DS DS

DP DP

U-921

CLINDAMYCIN PHOSPHATE; TRETINOIN - VELTIN N050803 001 5690923 Nov 25, 2014 CLINDAMYCIN PHOSPHATE; TRETINOIN - ZIANA N050802 001 6387383 Aug 03, 2020 RE41134 Feb 24, 2015 CLOBAZAM - ONFI N202067 001 CLOBAZAM - ONFI N202067 002 CLOBAZAM - ONFI N202067 003 CLOBETASOL PROPIONATE - CLOBEX Sep N021535 001 6106848 CLOBETASOL PROPIONATE - CLOBEX N021644 001 7316810 Jun 7700081 Jan 8066975 Jun 8066976 Jun CLOBETASOL PROPIONATE - CLOBEX N021835 001 5972920 Feb 5990100 Mar

DP

DP DP

U-916 U-1033

NCE ODE

Oct Oct

21, 2016 21, 2018

NCE ODE

Oct Oct

21, 2016 21, 2018

NCE ODE 22, 2017

Oct Oct

21, 2016 21, 2018

17, 03, 17, 17,

2019 2022 2019 2019

DP U-1044 DP DP

12, 2018 24, 2018

DP DP

U-742

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 35 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-484

EXCLUSIVITY CODE(S)

CLOBETASOL PROPIONATE - OLUX N021142 001 6126920

Mar

01, 2016

CLOBETASOL PROPIONATE - OLUX E Sep N022013 001 6730288 Sep 7029659 CLOFARABINE - CLOLAR N021673 001 5661136 5661136*PED

08, 2019 08, 2019

DP DP

Jan Jul

14, 2018 14, 2018

U-626

ODE PED

Dec Jun

28, 2011 28, 2012

CLONIDINE HYDROCHLORIDE - JENLOGA N022331 001 5869100 Oct CLONIDINE HYDROCHLORIDE - JENLOGA N022331 002 5869100 Oct CLONIDINE HYDROCHLORIDE - KAPVAY N022331 003 5869100 Oct CLONIDINE HYDROCHLORIDE - KAPVAY N022331 004 5869100 Oct CLOPIDOGREL BISULFATE - PLAVIX N020839 001 4847265 4847265*PED 5576328 5576328*PED 6429210 6429210*PED 6504030 6504030*PED CLOPIDOGREL BISULFATE - PLAVIX N020839 002 4847265 4847265*PED 6429210 6429210*PED 6504030 6504030*PED CLOZAPINE - FAZACLO ODT N021590 001 6024981 6106861 6221392 CLOZAPINE - FAZACLO ODT N021590 002 6024981 6106861 6221392 CLOZAPINE - FAZACLO ODT N021590 003 6024981 6106861 6221392 CLOZAPINE - FAZACLO ODT N021590 004 6024981 6106861 6221392 CLOZAPINE - FAZACLO ODT N021590 005 6024981 6106861 6221392 CLOZAPINE - FAZACLO ODT N021590 006 6024981 6106861 6221392

13, 2013

DP

NP

Sep

29, 2012

13, 2013

DP

13, 2013

DP

NP

Sep

28, 2013

13, 2013

DP

NP

Sep

28, 2013

Nov May Jan Jul Jun Dec Jun Dec

17, 17, 31, 31, 10, 10, 10, 10,

2011 2012 2014 2014 2019 2019 2019 2019

DS

DP U-432 Y

M-61 PED

May Nov

06, 2014 06, 2014

DS DS

DP

Nov May Jun Dec Jun Dec

17, 17, 10, 10, 10, 10,

2011 2012 2019 2019 2019 2019

DS DS DS

DP DP

M-61 PED

May Nov

06, 2014 06, 2014

Apr Dec Apr

09, 2018 05, 2017 09, 2018

DP DP DP

Apr Dec Apr

09, 2018 05, 2017 09, 2018

DP DP DP

Apr Dec Apr

09, 2018 05, 2017 09, 2018

DP DP DP

Apr Dec Apr

09, 2018 05, 2017 09, 2018

DP DP DP

Apr Dec Apr

09, 2018 05, 2017 09, 2018

DP DP DP

Apr Dec Apr

09, 2018 05, 2017 09, 2018

DP DP DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 36 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-1007 U-1020 U-1020 U-1116 U-1007 U-1116 U-1007 U-1161 U-1166 U-1007 U-1161 U-1116

EXCLUSIVITY CODE(S)
I-603 ODE

COLCHICINE - COLCRYS N022352 001 7601758 7619004 7820681 7906519 7915269 7935731 7964647 7964648 7981938 8093296 8093297 8093298

Feb Dec Feb Feb Feb Dec Oct Feb Oct Oct Oct Oct

10, 03, 17, 17, 17, 03, 06, 17, 06, 06, 06, 06,

2029 2028 2029 2029 2029 2028 2028 2029 2028 2028 2028 2028

Jul Jul

30, 2012 29, 2016

COLESEVELAM HYDROCHLORIDE - WELCHOL Jun 10, 2014 N021141 001 5607669 Dec 10, 2014 5607669*PED Apr 29, 2014 5679717 Oct 29, 2014 5679717*PED Dec 02, 2014 5693675 Jun 02, 2015 5693675*PED Apr 29, 2014 5917007 Oct 29, 2014 5917007*PED Jun 10, 2014 5919832 Dec 10, 2014 5919832*PED Jun 10, 2014 6066678 Dec 10, 2014 6066678*PED Jun 10, 2014 6433026 Dec 10, 2014 6433026*PED COLESEVELAM HYDROCHLORIDE - WELCHOL Jun 10, 2014 N021176 001 5607669 Dec 10, 2014 5607669*PED Apr 29, 2014 5679717 Oct 29, 2014 5679717*PED Dec 02, 2014 5693675 Jun 02, 2015 5693675*PED Apr 29, 2014 5917007 Oct 29, 2014 5917007*PED Apr 29, 2014 5919832 Oct 29, 2014 5919832*PED Apr 29, 2014 6066678 Oct 29, 2014 6066678*PED Apr 29, 2014 6433026 Oct 29, 2014 6433026*PED Apr 29, 2014 6784254 Oct 29, 2014 6784254*PED Apr 29, 2014 7101960 Oct 29, 2014 7101960*PED Apr 17, 2022 7229613 Oct 17, 2022 7229613*PED

U-323 U-323

U-323

U-323

U-323 U-323 DS DS DS DS DS DS DS DP DP U-757 U-851 U-323 U-323

I-608 PED PED

Oct Apr Jul

02, 2012 02, 2013 18, 2011

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 37 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-757 U-757
DS
DS
DS
DS
DS
DS DS
DP
DP
U-757

U-493

U-757

U-757

EXCLUSIVITY CODE(S)
I-608 PED PED

COLESEVELAM HYDROCHLORIDE - WELCHOL N022362 001 5607669 Jun 10, 2014 5607669*PED Dec 10, 2014 5679717 Apr 29, 2014 5679717*PED Oct 29, 2014

5693675 Dec 02, 2014
5693675*PED Jun 02, 2015
5917007 Apr 29, 2014
5917007*PED Oct 29, 2014
5919832 Apr 29, 2014
5919832*PED Oct 29, 2014
6066678 Apr 29, 2014
6066678*PED Oct 29, 2014
6433026 Apr 29, 2014
6433026*PED Oct 29, 2014
6784254 Apr 29, 2014
6784254*PED Oct 29, 2014
7101960 Apr 29, 2014
7101960*PED Oct 29, 2014
7229613 Apr 17, 2022
7229613*PED Oct 17, 2022
COLESEVELAM HYDROCHLORIDE - WELCHOL N022362 002 5607669 Jun 10, 2014 5607669*PED Dec 10, 2014 5679717 Apr 29, 2014
5679717*PED Oct 29, 2014
5693675 Dec 02, 2014
5693675*PED Jun 02, 2015
5917007 Apr 29, 2014 5917007*PED Oct 29, 2014

5919832 Apr 29, 2014
5919832*PED Oct 29, 2014
6066678 Apr 29, 2014 6066678*PED Oct 29, 2014

6433026 Apr 29, 2014
6433026*PED Oct 29, 2014
6784254 Apr 29, 2014
6784254*PED Oct 29, 2014
7101960 Apr 29, 2014
7101960*PED Oct 29, 2014
7229613 Apr 17, 2022
7229613*PED Oct 17, 2022
COLESTIPOL HYDROCHLORIDE - COLESTID N020222 001 5490987 Feb 13, 2013 CONIVAPTAN HYDROCHLORIDE - VAPRISOL N021697 001 5723606 Dec 15, 2019 5723606 Dec 15, 2019

Oct Apr Jul

02, 2012 02, 2013 18, 2011

U-757 U-757
DS
DS
DS
DS
DS
DS DS
DP
DP
U-757

U-493
U-757

U-757

I-608 PED PED

Oct Apr Jul

02, 2012 02, 2013 18, 2011

DP

DS DS

DP DP

U-868 U-698

CONIVAPTAN HYDROCHLORIDE - VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER N021697 002 5723606 Dec 15, 2019 DS DP U-698 DS DP U-868 5723606 Dec 15, 2019 CORTICOTROPIN - H.P. ACTHAR GEL N008372 008 CRIZOTINIB - XALKORI N202570 001 7230098 7825137 7858643 CRIZOTINIB - XALKORI N202570 002 7230098 7825137 7858643

ODE Mar May Oct 01, 2025 12, 2027 08, 2029 DS U-1179 DS DP

Oct

15, 2017

NCE ODE

Aug Aug

26, 2016 26, 2018

Mar May Oct

01, 2025 12, 2027 08, 2029

DS U-1179 DS DP

NCE ODE

Aug Aug

26, 2016 26, 2018

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 38 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DP DP DP U-817 U-1152

EXCLUSIVITY CODE(S)

CYANOCOBALAMIN - NASCOBAL N021642 001 7229636 7404489 7879349

Jun Mar Jun

11, 2024 12, 2024 01, 2024

CYCLOBENZAPRINE HYDROCHLORIDE - AMRIX N021777 001 7387793 Feb 26, 7544372 Nov 14, 7790199 Nov 14, 7820203 Nov 14, 7829121 Nov 14, CYCLOBENZAPRINE HYDROCHLORIDE - AMRIX N021777 002 7387793 Feb 26, 7544372 Nov 14, 7790199 Nov 14, 7820203 Nov 14, 7829121 Nov 14, CYCLOSPORINE - NEORAL N050715 001 5342625 5741512 5985321 6258808 6262022 CYCLOSPORINE - NEORAL N050715 002 5342625 5741512 5985321 6258808 6262022 CYCLOSPORINE - NEORAL N050715 003 5342625 5741512 5985321 6258808 6262022 CYCLOSPORINE - NEORAL N050716 001 5342625 5741512 5985321 6258808 6262022 CYCLOSPORINE - RESTASIS N050790 001 5474979 CYTARABINE - DEPOCYT N021041 001 5455044 5723147

2025 2023 2023 2023 2023

DP U-979 DP DP U-1088

2025 2023 2023 2023 2023

DP U-979 DP DP U-1088

Aug Aug Sep Jun Jun

30, 30, 26, 25, 25,

2011 2011 2014 2012 2012

DP DP DP DP DP

U-906

Aug Aug Sep Jun Jun

30, 30, 26, 25, 25,

2011 2011 2014 2012 2012

DP DP DP DP DP

U-906

Aug Aug Sep Jun Jun

30, 30, 26, 25, 25,

2011 2011 2014 2012 2012

DP DP DP DP DP

U-906

Aug Aug Sep Jun Jun

30, 30, 26, 25, 25,

2011 2011 2014 2012 2012

DP DP DP DP DP

U-906

May

17, 2014

DP

May Mar

14, 2013 03, 2015

DP

U-806 U-806

DABIGATRAN ETEXILATE MESYLATE - PRADAXA N022512 001 6087380 Feb 18, 2018 7866474 Aug 31, 2027 Sep 07, 2025 7932273 DABIGATRAN ETEXILATE MESYLATE - PRADAXA N022512 002 6087380 Feb 18, 2018 7866474 Aug 31, 2027 Sep 07, 2025 7932273 DALFAMPRIDINE - AMPYRA N022250 001 5370879 5540938 8007826

DS DS

DP DP DP

U-1089

NCE

Oct

19, 2015

DS DS

DP DP DP

U-1089

NCE

Oct

19, 2015

Dec Jul May

06, 2011 30, 2013 26, 2027

DP U-1030 U-1030

NCE ODE

Jan Jan

22, 2015 22, 2017

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 39 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DP U-124 DP

EXCLUSIVITY CODE(S)

DAPSONE - ACZONE N021794 001 5863560 6060085 6620435 DAPTOMYCIN - CUBICIN N021572 001 6468967 6852689 8058238 DAPTOMYCIN - CUBICIN N021572 002 6468967 6852689 8003673 8058238 RE39071

Sep Sep Sep

11, 2016 11, 2016 11, 2016

Sep Sep Nov

24, 2019 24, 2019 28, 2020

U-282 U-282 DS DP

Sep Sep Sep Nov Jun

24, 24, 04, 28, 15,

2019 2019 2028 2020 2016

U-282 U-282 U-1180 DS DS DP DP U-728

DARIFENACIN HYDROBROMIDE - ENABLEX N021513 001 5096890 Mar 6106864 Aug DARIFENACIN HYDROBROMIDE - ENABLEX Mar N021513 002 5096890 Aug 6106864 DARUNAVIR ETHANOLATE - PREZISTA Dec N021976 001 5843946 Dec 5843946 Dec 5843946 Jun 5843946*PED Jun 6037157 Dec 6037157*PED Aug 6248775 Feb 6248775*PED Aug 6335460 Aug 6335460 Aug 6335460 Feb 6335460*PED Jun 6703403 Dec 6703403*PED Jun 7470506 Dec 7470506*PED Dec 7700645 Jun 7700645*PED Oct RE42889 Apr RE42889*PED DARUNAVIR ETHANOLATE - PREZISTA N021976 002 5843946 Dec 5843946 Dec 5843946 Dec 5843946*PED Jun 6037157 Jun 6037157*PED Dec 6248775 Aug Feb 6248775*PED Aug 6335460 Aug 6335460 Aug 6335460 Feb 6335460*PED Jun 6703403 Dec 6703403*PED Jun 7470506 Dec 7470506*PED Dec 7700645 Jun 7700645*PED Oct RE42889 Apr RE42889*PED

13, 2015 21, 2016

DS

DP DP

U-631 U-630

13, 2015 21, 2016

DS

DP DP

U-631 U-630

01, 01, 01, 01, 26, 26, 13, 13, 25, 25, 25, 25, 26, 26, 23, 23, 26, 26, 19, 19,

2015 2015 2015 2016 2016 2016 2014 2015 2012 2012 2012 2013 2016 2016 2019 2019 2026 2027 2016 2017

DP DP DP

U-744 U-903 U-935 U-935

DS DS DS DS DP DP DP U-935 U-903 U-744 U-935 U-935 DS DP DP

D-129 D-119 I-578 NPP PED PED PED PED PED

Dec Dec Oct Dec Jun Dec Apr Jun Jun

13, 18, 21, 16, 16, 23, 21, 13, 18,

2013 2011 2011 2014 2015 2011 2012 2014 2012

01, 01, 01, 01, 26, 26, 13, 13, 25, 25, 25, 25, 26, 26, 23, 23, 26, 26, 19, 19,

2015 2015 2015 2016 2016 2016 2014 2015 2012 2012 2012 2013 2016 2016 2019 2019 2026 2027 2016 2017

DP DP DP

U-935 U-744 U-903 U-935

DS DS DS DS DP DP DP U-744 U-903 U-935 U-935 U-935 DS DP DP

D-129 D-119 I-578 NPP PED PED PED PED PED

Dec Dec Oct Dec Jun Dec Apr Jun Jun

13, 18, 21, 16, 16, 23, 21, 13, 18,

2013 2011 2011 2014 2015 2011 2012 2014 2012

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 40 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DP DP DP U-744 U-903 U-935 U-935 DS DS DS DP DP U-935 U-903 U-935 U-935 DS DP DP

EXCLUSIVITY CODE(S)
D-129 D-119 D-118 I-578 NPP PED PED PED PED PED PED

DARUNAVIR ETHANOLATE - PREZISTA Dec N021976 003 5843946 Dec 5843946 Dec 5843946 Jun 5843946*PED Jun 6037157 Dec 6037157*PED Aug 6248775 Feb 6248775*PED Aug 6335460 Aug 6335460 Feb 6335460*PED Jun 6703403 Dec 6703403*PED Jun 7470506 Dec 7470506*PED Dec 7700645 Jun 7700645*PED Oct RE42889 Apr RE42889*PED DARUNAVIR ETHANOLATE - PREZISTA N021976 004 5843946 Dec 5843946*PED Jun 6037157 Jun 6037157*PED Dec 6248775 Aug 6248775*PED Feb 6335460 Aug 6335460*PED Feb 6703403 Jun 6703403*PED Dec 7470506 Jun 7470506*PED Dec 7700645 Dec 7700645*PED Jun RE42889 Oct RE42889*PED Apr DARUNAVIR ETHANOLATE - PREZISTA N021976 005 5843946 Dec 5843946*PED Jun 6037157 Jun 6037157*PED Dec 6248775 Aug Feb 6248775*PED Aug 6335460 Feb 6335460*PED Jun 6703403 Dec 6703403*PED Jun 7470506 Dec 7470506*PED Dec 7700645 Jun 7700645*PED Oct RE42889 Apr RE42889*PED DARUNAVIR ETHANOLATE - PREZISTA N202895 001 DASATINIB - SPRYCEL N021986 001 6596746 6596746 7125875 7125875 7153856 7491725

01, 01, 01, 01, 26, 26, 13, 13, 25, 25, 25, 26, 26, 23, 23, 26, 26, 19, 19,

2015 2015 2015 2016 2016 2016 2014 2015 2012 2012 2013 2016 2016 2019 2019 2026 2027 2016 2017

Dec Dec Oct Oct Dec Jun Dec Apr Jun Jun Apr

13, 18, 21, 21, 16, 16, 23, 21, 18, 13, 21,

2013 2011 2011 2011 2014 2015 2011 2012 2012 2014 2012

01, 01, 26, 26, 13, 13, 25, 25, 26, 26, 23, 23, 26, 26, 19, 19,

2015 2016 2016 2016 2014 2015 2012 2013 2016 2016 2019 2019 2026 2027 2016 2017

DP

U-935 U-935

DS DS DP U-935 U-935 U-935 DS DP DP

D-129 D-119 NPP NS PED PED PED PED PED

Dec Dec Dec Dec Jun Dec Jun Jun Jun

13, 18, 16, 18, 16, 23, 18, 13, 18,

2013 2011 2014 2011 2015 2011 2012 2014 2012

01, 01, 26, 26, 13, 13, 25, 25, 26, 26, 23, 23, 26, 26, 19, 19,

2015 2016 2016 2016 2014 2015 2012 2013 2016 2016 2019 2019 2026 2027 2016 2017

DP

U-935 U-935

DS DS DP U-935 U-935 U-935 DS DP DP

D-129 D-119 NPP NS PED PED PED PED PED

Dec Dec Dec Dec Jun Dec Jun Jun Jun

13, 18, 16, 18, 16, 23, 18, 13, 18,

2013 2011 2014 2011 2015 2011 2012 2014 2012

NDF PED Jun Jun Apr Apr Apr Mar 28, 28, 13, 13, 28, 28, 2020 2020 2020 2020 2020 2026 DS DS DP DP U-780 U-748 U-780 U-779 U-780

Dec Jun

16, 2014 16, 2015

D-120 M-94 ODE ODE

May Oct Jun Jun

21, 28, 28, 28,

2012 2013 2013 2013

DS

DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 41 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DS DS DP DP U-780 U-748 U-780 U-779 U-780

EXCLUSIVITY CODE(S)
D-120 M-94 ODE ODE

DASATINIB - SPRYCEL N021986 002 6596746 6596746 7125875 7125875 7153856 7491725 DASATINIB - SPRYCEL N021986 003 6596746 6596746 7125875 7125875 7153856 7491725 DASATINIB - SPRYCEL N021986 004 6596746 6596746 7125875 7125875 7153856 7491725 DASATINIB - SPRYCEL N021986 005 6596746 6596746 7125875 7125875 7153856 7491725 DASATINIB - SPRYCEL N021986 006 6596746 6596746 7125875 7125875 7153856 7491725 DECITABINE - DACOGEN N021790 001 DEFERASIROX - EXJADE N021882 001 6465504 6596750 DEFERASIROX - EXJADE N021882 002 6465504 6596750 DEFERASIROX - EXJADE N021882 003 6465504 6596750 DEFERIPRONE - FERRIPROX N021825 001 DEGARELIX ACETATE - FIRMAGON N022201 001 5925730 DEGARELIX ACETATE - FIRMAGON N022201 002 5925730

Jun Jun Apr Apr Apr Mar

28, 28, 13, 13, 28, 28,

2020 2020 2020 2020 2020 2026

May Oct Jun Jun

21, 28, 28, 28,

2012 2013 2013 2013

DS

DP

Jun Jun Apr Apr Apr Mar

28, 28, 13, 13, 28, 28,

2020 2020 2020 2020 2020 2026

DS DS

DP DP

U-780 U-748 U-780 U-779 U-780

D-120 M-94 ODE ODE

May Oct Jun Jun

21, 28, 28, 28,

2012 2013 2013 2013

DS

DP

Jun Jun Apr Apr Apr Mar

28, 28, 13, 13, 28, 28,

2020 2020 2020 2020 2020 2026

DS DS

DP DP

U-780 U-748 U-779 U-780 U-780

D-120 M-94 ODE ODE

May Oct Jun Jun

21, 28, 28, 28,

2012 2013 2013 2013

DS

DP

Jun Jun Apr Apr Apr Mar

28, 28, 13, 13, 28, 28,

2020 2020 2020 2020 2020 2026

DS DS

DP DP

U-748 U-780 U-780 U-779 U-780

D-120 M-94 ODE ODE

May Oct Jun Jun

21, 28, 28, 28,

2012 2013 2013 2013

DS

DP

Jun Jun Apr Apr Apr Mar

28, 28, 13, 13, 28, 28,

2020 2020 2020 2020 2020 2026

DS DS

DP DP

U-748 U-780 U-780 U-779 U-780

D-120 M-94 ODE ODE

May Oct Jun Jun

21, 28, 28, 28,

2012 2013 2013 2013

DS

DP

D-123 ODE Apr Jun 05, 2019 24, 2017 DS DS DP U-735

Mar May

11, 2013 02, 2013

ODE

Nov

02, 2012

Apr Jun

05, 2019 24, 2017

DS DS

DP U-735

ODE

Nov

02, 2012

Apr Jun

05, 2019 24, 2017

DS DS

DP U-735

ODE

Nov

02, 2012

NCE ODE Apr 11, 2017 DS DP U-943

Oct Oct

14, 2016 14, 2018

NCE

Dec

24, 2013

Apr

11, 2017

DS

DP

U-943

NCE

Dec

24, 2013

DELAVIRDINE MESYLATE - RESCRIPTOR N020705 001 5563142 Oct

08, 2013

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 42 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)

DELAVIRDINE MESYLATE - RESCRIPTOR N020705 002 5563142 Oct 6177101 Jun DESFLURANE - SUPRANE N020118 001 5617906 5617906*PED

08, 2013 07, 2019

Apr Oct

08, 2014 08, 2014

DP

DESIRUDIN RECOMBINANT - IPRIVASK N021271 001 5733874 Mar DESLORATADINE - CLARINEX N021165 001 6100274 6100274*PED 7211582 7211582*PED 7214683 7214683*PED 7214684 7214684*PED 7405223 7405223*PED DESLORATADINE - CLARINEX N021300 001 6514520 6514520*PED 7211582 7211582*PED 7214683 7214683*PED 7214684 7214684*PED DESLORATADINE - CLARINEX N021312 001 5607697 5607697*PED 6100274 6100274*PED 7211582 7211582*PED 7214683 7214683*PED 7214684 7214684*PED 7618649 7618649*PED DESLORATADINE - CLARINEX N021312 002 5607697 5607697*PED 6100274 6100274*PED 7211582 7211582*PED 7214683 7214683*PED 7214684 7214684*PED 7618649 7618649*PED

31, 2015

Jul Jan Dec Jun Dec Jun Dec Jun Jul Jan

07, 07, 30, 30, 30, 30, 30, 30, 07, 07,

2019 2020 2014 2015 2014 2015 2014 2015 2019 2020

U-809 DP U-138 U-886

Jun Dec Dec Jun Dec Jun Dec Jun

01, 01, 30, 30, 30, 30, 30, 30,

2018 2018 2014 2015 2014 2015 2014 2015

DP U-809 DP U-138

Jun Dec Jul Jan Dec Jun Dec Jun Dec Jun Dec Jun

07, 07, 07, 07, 30, 30, 30, 30, 30, 30, 19, 19,

2015 2015 2019 2020 2014 2015 2014 2015 2014 2015 2020 2021

DP DP U-809 DP U-138 DP U-1017

Jun Dec Jul Jan Dec Jun Dec Jun Dec Jun Dec Jun

07, 07, 07, 07, 30, 30, 30, 30, 30, 30, 19, 19,

2015 2015 2019 2020 2014 2015 2014 2015 2014 2015 2020 2021

DP DP U-809 DP U-138 DP U-1017

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 43 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)

DESLORATADINE; PSEUDOEPHEDRINE SULFATE - CLARINEX D 24 HOUR N021605 001 6100274 Jul 07, 2019 DP 6100274*PED Jan 07, 2020 DP 6979463 Mar 28, 2022 DP 7214683 Dec 30, 2014 7214683*PED Jun 30, 2015 U-138 7214684 Dec 30, 2014 7214684*PED Jun 30, 2015 DP U-1017 7618649 Dec 19, 2020 7618649*PED Jun 19, 2021 DP 7820199 Mar 28, 2022 7820199*PED Sep 28, 2022 DESLORATADINE; PSEUDOEPHEDRINE SULFATE - CLARINEX-D N021313 001 6100274 Jul 07, 2019 6100274*PED Jan 07, 2020 6709676 Feb 18, 2021 7214683 Dec 30, 2014 7214683*PED Jun 30, 2015 7214684 Dec 30, 2014 7214684*PED Jun 30, 2015 7618649 Dec 19, 2020 7618649*PED Jun 19, 2021 DESMOPRESSIN ACETATE - DDAVP N017922 001 5500413 5674850 5763407 DESMOPRESSIN ACETATE - DDAVP N017922 002 5500413 5674850 5763407 DESMOPRESSIN ACETATE - DDAVP N018938 001 5500413 5763407 DESMOPRESSIN ACETATE - DDAVP N018938 002 5500413 5763407 DESMOPRESSIN ACETATE - DDAVP N019955 001 5500413 5674850 5763407 7022340 DESMOPRESSIN ACETATE - DDAVP N019955 002 5500413 5674850 5763407 7022340 12 HOUR DP DP DP U-707

U-138 DP U-1017

Jun Dec Jun

29, 2013 23, 2013 29, 2013

Jun Dec Jun

29, 2013 23, 2013 29, 2013

Jun Jun

29, 2013 29, 2013

Jun Jun

29, 2013 29, 2013

Jun Dec Jun Apr

29, 23, 29, 30,

2013 2013 2013 2023

DP

Jun Dec Jun Apr

29, 23, 29, 30,

2013 2013 2013 2023

DP

DESMOPRESSIN ACETATE - DDAVP (NEEDS NO REFRIGERATION) N017922 003 5482931 Jun 29, 2013 5500413 Jun 29, 2013 5674850 Dec 23, 2013 5763407 Jun 29, 2013 DESMOPRESSIN ACETATE - DESMOPRESSIN ACETATE N021795 001 7022340 Apr 30, 2023 DESMOPRESSIN ACETATE - DESMOPRESSIN ACETATE N021795 002 7022340 Apr 30, 2023 DESONIDE - DESONATE N021844 001 6387383

DP

DP

Aug

03, 2020

DS

DP

U-783

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 44 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DP DP

EXCLUSIVITY CODE(S)

DESONIDE - VERDESO N021978 001 6730288 7029659

Sep Sep

08, 2019 08, 2019

DESVENLAFAXINE SUCCINATE - PRISTIQ N021992 001 6673838 Feb DESVENLAFAXINE SUCCINATE - PRISTIQ N021992 002 6673838 Feb DEXAMETHASONE - OZURDEX N022315 001 6726918 6726918 6899717 7033605 7767223 8034366 8034366 8034370 8043628 8063031

11, 2022

DS

DP

U-860

NCE

Mar

01, 2013

11, 2022

DS

DP

U-860

NCE

Mar

01, 2013

Oct Oct Nov Oct Nov Jan Jan Jan Oct Oct

20, 20, 01, 20, 28, 09, 09, 09, 20, 20,

2020 2020 2023 2020 2021 2023 2023 2023 2020 2020

DP DP DP DP DP DP DP DP DP

U-1205 U-1204 U-1206

NDF ODE

Jun Sep

17, 2012 24, 2017

U-1204 U-1205 U-1205

DEXAMETHASONE; TOBRAMYCIN - TOBRADEX ST Aug 03, 2028 N050818 001 7795316 DEXLANSOPRAZOLE - DEXILANT N022287 001 6462058 6462058 6462058 6462058*PED 6664276 6664276 6664276 6664276*PED 6939971 6939971 6939971 6939971*PED 7285668 7285668*PED 7790755 7790755*PED DEXLANSOPRAZOLE - DEXILANT N022287 002 6462058 6462058 6462058 6462058*PED 6664276 6664276 6664276 6664276*PED 6939971 6939971 6939971 6939971*PED 7285668 7285668*PED 7790755 7790755*PED

DP

U-1082

Jun Jun Jun Dec Jun Jun Jun Dec Jun Jun Jun Dec Jun Dec Aug Feb

15, 15, 15, 15, 15, 15, 15, 15, 15, 15, 15, 15, 15, 15, 02, 02,

2020 2020 2020 2020 2020 2020 2020 2020 2020 2020 2020 2020 2020 2020 2026 2027

DS DS DS DS DS DS

DP DP DP DP DP DP

U-949 U-951 U-950 U-951 U-949 U-950 U-949 U-950 U-951

NP PED

Jan Jul

30, 2012 30, 2012

DS DP

Jun Jun Jun Dec Jun Jun Jun Dec Jun Jun Jun Dec Jun Dec Aug Feb

15, 15, 15, 15, 15, 15, 15, 15, 15, 15, 15, 15, 15, 15, 02, 02,

2020 2020 2020 2020 2020 2020 2020 2020 2020 2020 2020 2020 2020 2020 2026 2027

DS DS DS DS DS DS

DP DP DP DP DP DP

U-951 U-950 U-949 U-951 U-950 U-949 U-949 U-950 U-951

NP PED

Jan Jul

30, 2012 30, 2012

DS DP

DEXMEDETOMIDINE HYDROCHLORIDE - PRECEDEX Jul 15, 2013 N021038 001 4910214 Sep 06, 2011 5344840 Mar 31, 2019 6716867 DEXMETHYLPHENIDATE HYDROCHLORIDE - FOCALIN N021278 001 5908850 Dec 04, 2015 6355656 Dec 04, 2015 6528530 Dec 04, 2015

DS

DP

U-421 U-912 U-572

I-577

Oct

17, 2011

U-422 DS DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 45 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY
EXPIRATION
DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-422 DS DP

EXCLUSIVITY CODE(S)

DEXMETHYLPHENIDATE HYDROCHLORIDE - FOCALIN N021278 002 5908850 Dec 04, 2015 6355656 Dec 04, 2015 6528530 Dec 04, 2015 DEXMETHYLPHENIDATE HYDROCHLORIDE - FOCALIN N021278 003 5908850 Dec 04, 2015 6355656 Dec 04, 2015 6528530 Dec 04, 2015 DEXMETHYLPHENIDATE HYDROCHLORIDE - FOCALIN XR N021802 001 5837284 Dec 04, 2015 5908850 Dec 04, 2015 6228398 Nov 01, 2019 6355656 Dec 04, 2015 6528530 Dec 04, 2015 6635284 Dec 04, 2015 6730325 Nov 01, 2019 7431944 Dec 04, 2015 DEXMETHYLPHENIDATE HYDROCHLORIDE - FOCALIN XR N021802 002 5837284 Dec 04, 2015 5908850 Dec 04, 2015 6228398 Nov 01, 2019 6355656 Dec 04, 2015 6528530 Dec 04, 2015 6635284 Dec 04, 2015 6730325 Nov 01, 2019 7431944 Dec 04, 2015 DEXMETHYLPHENIDATE HYDROCHLORIDE - FOCALIN XR N021802 003 5837284 Dec 04, 2015 5908850 Dec 04, 2015 6228398 Nov 01, 2019 6355656 Dec 04, 2015 6528530 Dec 04, 2015 6635284 Dec 04, 2015 6730325 Nov 01, 2019 7431944 Dec 04, 2015 DEXMETHYLPHENIDATE HYDROCHLORIDE - FOCALIN XR N021802 004 5837284 Dec 04, 2015 5908850 Dec 04, 2015 6228398 Nov 01, 2019 6355656 Dec 04, 2015 6528530 Dec 04, 2015 6635284 Dec 04, 2015 6730325 Nov 01, 2019 7431944 Dec 04, 2015 DEXMETHYLPHENIDATE HYDROCHLORIDE - FOCALIN XR N021802 005 5837284 Dec 04, 2015 5908850 Dec 04, 2015 6228398 Nov 01, 2019 6355656 Dec 04, 2015 6528530 Dec 04, 2015 6635284 Dec 04, 2015 6730325 Nov 01, 2019 7431944 Dec 04, 2015 DEXMETHYLPHENIDATE HYDROCHLORIDE - FOCALIN XR N021802 006 5837284 Dec 04, 2015 5908850 Dec 04, 2015 6228398 Nov 01, 2019 6355656 Dec 04, 2015 6528530 Dec 04, 2015 6635284 Dec 04, 2015 6730325 Nov 01, 2019 7431944 Dec 04, 2015

U-422 DS DP

DP DP DP DP DP DP DP U-678 U-676

D-121 M-80

Oct
23, 2012 Oct
17, 2011

U-677 U-676

DP DP DP DP DP DP DP U-678 U-676

D-121 M-80

Oct
23, 2012 Oct
17, 2011

U-677 U-676

DP DP DP DP DP DP DP U-678 U-676

D-121 M-80

Oct
23, 2012 Oct
17, 2011

U-677 U-676

DP DP DP DP DP DP DP U-678 U-676

D-121 M-80

Oct
23, 2012 Oct
17, 2011

U-677 U-676

DP DP DP DP DP DP DP DP

U-678 U-676

D-121 M-80

Oct
23, 2012 Oct
17, 2011

U-677 U-676

DP DP DP DP DP DP DP DP

U-677 U-678 U-676

D-121 M-80

Oct Oct

23, 2012
17, 2011

U-677 U-676

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 46 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DP DP DP DP DP DP DP DP

EXCLUSIVITY CODE(S)
D-121 M-80

DEXMETHYLPHENIDATE HYDROCHLORIDE - FOCALIN XR N021802 007 5837284 Dec 04, 2015 5908850 Dec 04, 2015 6228398 Nov 01, 2019 6355656 Dec 04, 2015 6528530 Dec 04, 2015 6635284 Dec 04, 2015 6730325 Nov 01, 2019 7431944 Dec 04, 2015 DEXMETHYLPHENIDATE HYDROCHLORIDE - FOCALIN XR N021802 008 5837284 Dec 04, 2015 5908850 Dec 04, 2015 6228398 Nov 01, 2019 6355656 Dec 04, 2015 6528530 Dec 04, 2015 6635284 Dec 04, 2015 6730325 Nov 01, 2019 7431944 Dec 04, 2015 DEXRAZOXANE HYDROCHLORIDE - TOTECT N022025 001 6727253 Mar DEXTROMETHORPHAN HYDROBROMIDE; N021620 001 6372252 6955821 7838032 DEXTROMETHORPHAN HYDROBROMIDE; N021620 002 6372252 6955821 7838032 DEXTROMETHORPHAN HYDROBROMIDE; N021879 001 5206248 7659282 RE38115

U-678 U-676

Oct Oct

23, 2012 17, 2011

U-677 U-676

DP DP DP DP DP DP DP DP

U-678 U-676

D-121 M-80

Oct Oct

23, 2012 17, 2011

U-677 U-676

13, 2020

U-829

ODE

Sep

06, 2014

GUAIFENESIN - MUCINEX DM Apr 28, 2020 DP DP U-685 Apr 28, 2020 DP Apr 28, 2020 GUAIFENESIN - MUCINEX DM Apr 28, 2020 DP DP U-685 Apr 28, 2020 DP Apr 28, 2020 QUINIDINE SULFATE - NUEDEXTA Mar 27, 2012 U-1093 U-1093 Aug 13, 2026 Jan 26, 2016 DP

NC

Oct

29, 2013

DEXTROMETHORPHAN POLISTIREX - DELSYM N018658 001 5980882 Apr 16, 2017 DIAZEPAM - DIASTAT N020648 001 5462740 DIAZEPAM - DIASTAT N020648 002 5462740 DIAZEPAM - DIASTAT N020648 003 5462740 DIAZEPAM - DIASTAT N020648 004 5462740 DIAZEPAM - DIASTAT N020648 005 5462740 DIAZEPAM - DIASTAT ACUDIAL N020648 006 5462740 DIAZEPAM - DIASTAT ACUDIAL N020648 007 5462740

DP

Sep

17, 2013

DP

Sep

17, 2013

DP

Sep

17, 2013

DP

Sep

17, 2013

DP

Sep

17, 2013

DP

Sep

17, 2013

DP

Sep

17, 2013

DP

DICLOFENAC EPOLAMINE - FLECTOR N021234 001 5607690 Apr DICLOFENAC POTASSIUM - CAMBIA N022165 001 6974595 7482377 7759394

13, 2014

DP

May May Jun

15, 2017 15, 2017 16, 2026

DS DS

DP DP

U-436 U-436 U-436

NDF

Jun

17, 2012

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 47 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DP U-980 U-1035 U-1111 U-980

EXCLUSIVITY CODE(S)
NDF

DICLOFENAC POTASSIUM - ZIPSOR N022202 001 6365180 7662858 7884095 7939518

Jul Feb Feb Feb

15, 24, 24, 24,

2019 2029 2029 2029

Jun

16, 2012

DICLOFENAC SODIUM - DICLOFENAC SODIUM N020809 001 5603929 Nov 16, 2014 5653972 Nov 16, 2014 DICLOFENAC SODIUM - PENNSAID N020947 001 DICLOFENAC SODIUM - SOLARAZE N021005 001 5639738 5792753 5852002 5914322 5929048 5985850

U-239 U-239

NDF Jun Aug Jun Aug Jun Aug 17, 11, 17, 11, 17, 11, 2014 2015 2014 2015 2014 2015 U-402 U-402 U-402 DP

Nov

04, 2012

DICLOFENAC SODIUM; MISOPROSTOL - ARTHROTEC N020607 001 5601843 Feb 11, 2014 DICLOFENAC SODIUM; MISOPROSTOL - ARTHROTEC N020607 002 5601843 Feb 11, 2014 DIDANOSINE - VIDEX N020154 002 5880106 5880106*PED DIDANOSINE - VIDEX N020154 003 5880106 5880106*PED DIDANOSINE - VIDEX N020154 004 5880106 5880106*PED DIDANOSINE - VIDEX N020154 005 5880106 5880106*PED DIDANOSINE - VIDEX N020154 006 5880106 5880106*PED

Jul Jan

22, 2011 22, 2012

Jul Jan

22, 2011 22, 2012

Jul Jan

22, 2011 22, 2012

Jul Jan

22, 2011 22, 2012

Jul Jan

22, 2011 22, 2012

DIENOGEST; ESTRADIOL VALERATE - NATAZIA Oct 25, N022252 001 6133251 Oct 25, 6133251 Oct 25, 6133251 Oct 25, 6884793 May 13, 8071577 DIFLUPREDNATE - DUREZOL N022212 001 6114319

2016 2016 2016 2016 2026

DP DP DP DP DP

U-828 U-112 U-1 U-1

Y Y Y Y

NP

May

06, 2013

May

18, 2019

DP

NCE

Jun

23, 2013

DILTIAZEM HYDROCHLORIDE - CARDIZEM CD N020062 001 5364620 Nov 14, 2011 5439689 Aug 08, 2012 DILTIAZEM HYDROCHLORIDE - CARDIZEM CD N020062 002 5364620 Nov 14, 2011 5439689 Aug 08, 2012 DILTIAZEM HYDROCHLORIDE - CARDIZEM CD N020062 003 5364620 Nov 14, 2011 5439689 Aug 08, 2012

U-3 U-107

U-3 U-107

U-3 U-107

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 48 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-3 U-107

EXCLUSIVITY CODE(S)

DILTIAZEM HYDROCHLORIDE - CARDIZEM CD N020062 004 5364620 Nov 14, 2011 5439689 Aug 08, 2012 DILTIAZEM HYDROCHLORIDE - CARDIZEM CD N020062 005 5439689 Aug 08, 2012 DILTIAZEM HYDROCHLORIDE - CARDIZEM LA N021392 001 5529791 Jun 25, 2013 6923984 Feb 25, 2021 7108866 Dec 17, 2019 DILTIAZEM HYDROCHLORIDE - CARDIZEM LA N021392 002 5529791 Jun 25, 2013 6923984 Feb 25, 2021 7108866 Dec 17, 2019 DILTIAZEM HYDROCHLORIDE - CARDIZEM LA N021392 003 5529791 Jun 25, 2013 6923984 Feb 25, 2021 7108866 Dec 17, 2019 DILTIAZEM HYDROCHLORIDE - CARDIZEM LA N021392 004 5529791 Jun 25, 2013 6923984 Feb 25, 2021 7108866 Dec 17, 2019 DILTIAZEM HYDROCHLORIDE - CARDIZEM LA N021392 005 5529791 Jun 25, 2013 6923984 Feb 25, 2021 7108866 Dec 17, 2019 DILTIAZEM HYDROCHLORIDE - CARDIZEM LA N021392 006 5529791 Jun 25, 2013 6923984 Feb 25, 2021 7108866 Dec 17, 2019 DILTIAZEM HYDROCHLORIDE - DILACOR XR N020092 001 5422123 Jun 06, 2012 DILTIAZEM HYDROCHLORIDE - DILACOR XR N020092 002 5422123 Jun 06, 2012 DILTIAZEM HYDROCHLORIDE - DILACOR XR N020092 003 5422123 Jun 06, 2012 DILTIAZEM HYDROCHLORIDE - DILTIAZEM HYDROCHLORIDE N020939 001 5529791 Jun 25, 2013 DILTIAZEM HYDROCHLORIDE - DILTIAZEM HYDROCHLORIDE N020939 002 5529791 Jun 25, 2013 DILTIAZEM HYDROCHLORIDE - DILTIAZEM HYDROCHLORIDE N020939 003 5529791 Jun 25, 2013 DILTIAZEM HYDROCHLORIDE - DILTIAZEM HYDROCHLORIDE N020939 004 5529791 Jun 25, 2013 DILTIAZEM HYDROCHLORIDE - TIAZAC N020401 001 5529791 Jun DILTIAZEM HYDROCHLORIDE - TIAZAC N020401 002 5529791 Jun DILTIAZEM HYDROCHLORIDE - TIAZAC N020401 003 5529791 Jun DILTIAZEM HYDROCHLORIDE - TIAZAC N020401 004 5529791 Jun

DP

U-107

DP DP

U-107

DP DP

U-107

DP DP

U-107

DP DP

U-107

DP DP

U-107

DP DP

U-107

25, 2013

25, 2013

25, 2013

25, 2013

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 49 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)

DILTIAZEM HYDROCHLORIDE - TIAZAC N020401 005 5529791 Jun DILTIAZEM HYDROCHLORIDE - TIAZAC N020401 006 5529791 Jun

25, 2013

25, 2013

DIMYRISTOYL LECITHIN; PERFLEXANE - IMAGENT Feb 25, 2014 N021191 001 5605673 May 16, 2014 5626833 5639443 Jun 17, 2014 5695741 Dec 09, 2014 5720938 Feb 24, 2015 5798091 Aug 25, 2015 6280704 Jul 30, 2013 6280705 Jul 30, 2013 6287539 Jul 30, 2013 DINOPROSTONE - CERVIDIL N020411 001 5269321 DIVALPROEX SODIUM - DEPAKOTE N019680 001 DIVALPROEX SODIUM - DEPAKOTE ER N021168 001 6419953 Dec 6419953*PED Jun 6511678 Dec 6511678*PED Jun 6528090 Dec 6528090*PED Jun 6528091 Dec 6528091*PED Jun 6713086 Dec 6713086*PED Jun 6720004 Dec 6720004*PED Jun DIVALPROEX SODIUM - DEPAKOTE ER N021168 002 6511678 Dec 6511678*PED Jun 6528090 Dec 6528090*PED Jun 6713086 Dec 6713086*PED Jun 6720004 Dec 6720004*PED Jun DOCETAXEL - TAXOTERE N020449 001 5438072 5438072*PED 5698582 5698582*PED 5714512 5714512*PED 5750561 5750561*PED DOCETAXEL - TAXOTERE N020449 003 5698582 5698582*PED 5714512 5714512*PED 5750561 5750561*PED

U-458 U-458 U-458

Jul

14, 2012

DP

U-110

PED 18, 18, 18, 18, 18, 18, 18, 18, 18, 18, 18, 18, 2018 2019 2018 2019 2018 2019 2018 2019 2018 2019 2018 2019

Sep

24, 2011

PED

Sep

24, 2011

DP U-106 DP DP U-579

18, 18, 18, 18, 18, 18, 18, 18,

2018 2019 2018 2019 2018 2019 2018 2019

PED DP DP DP U-579

Sep

24, 2011

Nov May Jul Jan Jul Jan Jul Jan

22, 22, 03, 03, 03, 03, 03, 03,

2013 2014 2012 2013 2012 2013 2012 2013

DP DP DP DP

M-61 PED

May Nov

13, 2013 13, 2013

Jul Jan Jul Jan Jul Jan

03, 03, 03, 03, 03, 03,

2012 2013 2012 2013 2012 2013

DP DP DP

M-61 PED

May Nov

13, 2013 13, 2013

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 50 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DP DP DP

EXCLUSIVITY CODE(S)
M-61 PED

DOCETAXEL - TAXOTERE N020449 004 5698582 5698582*PED 5714512 5714512*PED 5750561 5750561*PED DOCOSANOL - ABREVA N020941 001 4874794 5534554 DOFETILIDE - TIKOSYN N020931 001 4959366 6124363 DOFETILIDE - TIKOSYN N020931 002 4959366 6124363 DOFETILIDE - TIKOSYN N020931 003 4959366 6124363 DOLASETRON MESYLATE - ANZEMET N020623 001 4906755 DOLASETRON MESYLATE - ANZEMET N020623 002 4906755 DOLASETRON MESYLATE - ANZEMET N020624 001 4906755 DOLASETRON MESYLATE - ANZEMET N020624 002 4906755 DOLASETRON MESYLATE - ANZEMET N020624 003 4906755

Jul Jan Jul Jan Jul Jan

03, 03, 03, 03, 03, 03,

2012 2013 2012 2013 2012 2013

May Nov

13, 2013 13, 2013

Apr Dec

28, 2014 13, 2013

DP

U-815 U-815

Sep Oct

25, 2012 09, 2018

DS

DP

U-652

Sep Oct

25, 2012 09, 2018

DS

DP

U-652

Sep Oct

25, 2012 09, 2018

DS

DP

U-652

Jul

02, 2011

Jul

02, 2011

Jul

02, 2011

Jul

02, 2011

Jul

02, 2011

DONEPEZIL HYDROCHLORIDE - ARICEPT N020690 001 5985864 Dec 6140321 Dec 6245911 Dec 6372760 Mar DONEPEZIL HYDROCHLORIDE - ARICEPT N020690 002 5985864 Dec 6140321 Dec 6245911 Dec 6372760 Mar DONEPEZIL HYDROCHLORIDE - ARICEPT N022568 001

30, 30, 01, 31,

2016 2016 2018 2019

30, 30, 01, 31,

2016 2016 2018 2019

NP DP DP U-1062

Jul

23, 2013

DONEPEZIL HYDROCHLORIDE - ARICEPT ODT N021720 001 7727548 Jun 23, 2022 7727552 Mar 26, 2018 DONEPEZIL HYDROCHLORIDE - ARICEPT ODT N021720 002 7727548 Jun 23, 2022 7727552 Mar 26, 2018 DORIPENEM - DORIBAX N022106 001 5317016 DORIPENEM - DORIBAX N022106 002 5317016

DP DP

U-1062

Jun

05, 2015

DS

DP

U-282

NCE

Oct

12, 2012

Jun

05, 2015

DS

DP

U-282

NCE

Oct

12, 2012

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 51 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-620 DP DP DP DP DP U-620 DP U-620

EXCLUSIVITY CODE(S)
NP

DOXEPIN HYDROCHLORIDE - SILENOR Mar N022036 001 5502047 Jan 5585115 Jan 5725884 Jan 5866166 Jan 5948438 Jan 6103219 Feb 6211229 Jan 6217909 Aug 7915307 DOXEPIN HYDROCHLORIDE - SILENOR Mar N022036 002 5502047 Jan 5585115 Jan 5725884 Jan 5866166 Jan 5948438 Jan 6103219 Feb 6211229 Jan 6217909 Aug 7915307 DOXERCALCIFEROL - HECTOROL N020862 001 5602116 5602116 6903083 DOXERCALCIFEROL - HECTOROL N020862 002 5602116 5602116 6903083 DOXERCALCIFEROL - HECTOROL N020862 003 5602116 DOXERCALCIFEROL - HECTOROL N021027 001 5602116 6903083 7148211 DOXERCALCIFEROL - HECTOROL N021027 002 5602116 7148211

26, 09, 09, 09, 09, 09, 17, 09, 24,

2013 2015 2015 2015 2015 2015 2020 2015 2027

Mar

17, 2013

26, 09, 09, 09, 09, 09, 17, 09, 24,

2013 2015 2015 2015 2015 2015 2020 2015 2027

U-620 DP DP DP DP DP U-620 DP U-620

NP

Mar

17, 2013

Feb Feb Jul

11, 2014 11, 2014 18, 2021

U-278 U-987 DS DP Y

Feb Feb Jul

11, 2014 11, 2014 18, 2021

U-278 U-987 DS DP Y

Feb

11, 2014

U-987

Feb Jul Sep

11, 2014 18, 2021 14, 2023

U-321 DS DP DP Y

Feb Sep

11, 2014 14, 2023

U-321 DP

DOXORUBICIN HYDROCHLORIDE - DOXIL N050718 001 DOXORUBICIN HYDROCHLORIDE - DOXIL N050718 002 DOXYCYCLINE - ORACEA N050805 001 5789395 5919775 7211267 7232572 7749532 DOXYCYCLINE HYCLATE - DORYX N050795 001 6958161 DOXYCYCLINE HYCLATE - DORYX N050795 002 6958161 DOXYCYCLINE HYCLATE - DORYX N050795 003 6958161

ODE

May

17, 2014

ODE 30, 30, 05, 05, 19, 2016 2016 2022 2022 2027 U-925 U-925 U-925 U-925 U-1063

May

17, 2014

Aug Aug Apr Apr Dec

DP

Dec

15, 2022

DP

U-918

Dec

15, 2022

DP

U-918

Dec

15, 2022

DP

U-918

DRONEDARONE HYDROCHLORIDE - MULTAQ N022425 001 5223510 Jul 7323493 Jun

26, 2012 19, 2018

DS

DP DP

U-992

NCE

Jul

01, 2014

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 52 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DS

EXCLUSIVITY CODE(S)

DROSPIRENONE; ESTRADIOL - ANGELIQ N021355 002 6933395 Aug

11, 2017

DROSPIRENONE; ETHINYL ESTRADIOL - YASMIN N021098 001 5569652 Oct 29, 2013 6787531 Aug 31, 2020 Aug 11, 2017 6933395 DROSPIRENONE; ETHINYL ESTRADIOL - YAZ N021676 001 5569652 Oct 29, 5798338 Jul 10, 6787531 Aug 31, Aug 11, 6933395 Dec 20, 6958326 Dec 22, 6987101 Dec 20, 7163931 Jun 30, RE37564 Jun 30, RE37838 Jun 30, RE38253

U-1 DP DS

2013 2015 2020 2017 2021 2017 2021 2014 2014 2014

U-1 DP DP DP DP U-758 U-1 DP DP DP

DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM - BEYAZ N022532 001 5798338 Jul 10, 2015 DP DS 6441168 Apr 17, 2020 DP 6958326 Dec 30, 2021 U-1 7163931 Mar 03, 2022 DP RE37564 Jun 30, 2014 DP RE37838 Jun 30, 2014 DP RE38253 Jun 30, 2014 DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM - SAFYRAL N022574 001 5798338 Jul 10, 2015 DP DS 6441168 Apr 17, 2020 DP 6958326 Dec 20, 2021 U-1 7163931 Mar 03, 2022 DULOXETINE HYDROCHLORIDE - CYMBALTA N021427 001 5023269 Jun 11, 2013 5023269 Jun 11, 2013 5023269 Jun 11, 2013 5023269 Jun 11, 2013 5023269 Jun 11, 2013 5023269 Jun 11, 2013 5023269 Jun 11, 2013 5023269 Jun 11, 2013 5023269 Jun 11, 2013 5508276 Jul 18, 2014 6596756 Sep 10, 2019 DULOXETINE HYDROCHLORIDE - CYMBALTA N021427 002 5023269 Jun 11, 2013 5023269 Jun 11, 2013 5023269 Jun 11, 2013 5023269 Jun 11, 2013 5023269 Jun 11, 2013 5023269 Jun 11, 2013 5023269 Jun 11, 2013 5023269 Jun 11, 2013 5023269 Jun 11, 2013 5508276 Jul 18, 2014 6596756 Sep 10, 2019

NC NP

Sep Sep

24, 2013 24, 2013

NP

Dec

16, 2013

DS DS DS DS DS DS DS DS DS

DP DP DP DP DP DP DP DP DP DP

U-605 U-1094 U-799 U-398 U-839 U-797 U-795 U-882 U-796 U-882

I-632 I-617

Nov Nov

04, 2013 19, 2012

DS DS DS DS DS DS DS DS DS

DP DP DP DP DP DP DP DP DP DP

U-1094 U-605 U-882 U-839 U-799 U-795 U-796 U-797 U-398 U-882

I-632 I-617

Nov Nov

04, 2013 19, 2012

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 53 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DS DS DS DS DS DS DS DS DS DP DP DP DP DP DP DP DP DP DP U-799 U-605 U-1094 U-398 U-882 U-795 U-796 U-797 U-839 U-882

EXCLUSIVITY CODE(S)
I-632 I-617

DULOXETINE HYDROCHLORIDE - CYMBALTA Jun 11, 2013 N021427 004 5023269 Jun 11, 2013 5023269 Jun 11, 2013 5023269 Jun 11, 2013 5023269 Jun 11, 2013 5023269 Jun 11, 2013 5023269 Jun 11, 2013 5023269 Jun 11, 2013 5023269 Jun 11, 2013 5023269 Jul 18, 2014 5508276 Sep 10, 2019 6596756 DUTASTERIDE - AVODART N021319 001 5565467 5846976 5998427

Nov Nov

04, 2013 19, 2012

Nov Sep Sep

20, 2015 17, 2013 17, 2013 JALYN 2015 2013 2013

DS DS

DP DP U-476 U-477

DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE N022460 001 5565467 Nov 20, 5846976 Sep 17, Sep 17, 5998427 EFAVIRENZ - SUSTIVA N020972 001 5519021 5663169 5811423 6238695 6555133 6639071 6939964 EFAVIRENZ - SUSTIVA N020972 002 5519021 5663169 5811423 6238695 6555133 6639071 6939964 EFAVIRENZ - SUSTIVA N020972 003 5519021 5663169 5811423 6238695 6555133 6639071 6939964 EFAVIRENZ - SUSTIVA N021360 001 5519021 5663169 5811423 6639071 6939964 EFAVIRENZ - SUSTIVA N021360 002 5519021 5663169 5811423 6639071 6939964

DS DS

DP DP U-1065 U-1066

May Sep Aug Apr Apr Feb Jan

21, 02, 07, 06, 06, 14, 20,

2013 2014 2012 2019 2019 2018 2018

DS DS

DP DP DP U-257 U-256 U-248

DS DS

May Sep Aug Apr Apr Feb Jan

21, 02, 07, 06, 06, 14, 20,

2013 2014 2012 2019 2019 2018 2018

DS DS

DP DP DP U-257 U-256 U-248

DS DS

May Sep Aug Apr Apr Feb Jan

21, 02, 07, 06, 06, 14, 20,

2013 2014 2012 2019 2019 2018 2018

DS DS

DP DP DP U-257 U-256 U-248

DS DS

May Sep Aug Feb Jan

21, 02, 07, 14, 20,

2013 2014 2012 2018 2018

U-256 DS DS

May Sep Aug Feb Jan

21, 02, 07, 14, 20,

2013 2014 2012 2018 2018

DS

DP U-248 U-256

DS DS

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 54 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)

EFAVIRENZ; EMTRICITABINE; TENOFOVIR N021937 001 5519021 May Sep 5663169 Aug 5811423 Sep 5814639 Mar 5814639*PED Jul 5914331 Jan 5914331*PED Jul 5922695 Jan 5922695*PED Jul 5935946 Jan 5935946*PED Jul 5977089 Jan 5977089*PED Jul 6043230 Jan 6043230*PED Feb 6639071 Nov 6642245 May 6642245*PED Mar 6703396 Sep 6703396*PED Jan 6939964

DISOPROXIL FUMARATE - ATRIPLA 21, 2013 DS DP U-750 02, 2014 U-750 07, 2012 DS DP 29, 2015 29, 2016 DS 02, 2017 02, 2018 DS U-750 25, 2017 25, 2018 DS DP U-750 25, 2017 25, 2018 DS DP U-750 25, 2017 25, 2018 U-750 25, 2017 25, 2018 DS 14, 2018 U-750 04, 2020 04, 2021 DS DP 09, 2021 09, 2021 DS 20, 2018

EFLORNITHINE HYDROCHLORIDE - VANIQA N021145 001 5648394 Jul 15, 2014 ELETRIPTAN HYDROBROMIDE - RELPAX N021016 001 5545644 Dec 6110940 Aug ELETRIPTAN HYDROBROMIDE - RELPAX N021016 002 5545644 Dec 6110940 Aug ELTROMBOPAG OLAMINE - PROMACTA N022291 001 6280959 7160870 7332481 7452874 7473686 7547719 7790704 7795293 8052993 ELTROMBOPAG OLAMINE - PROMACTA N022291 002 6280959 7160870 7332481 7452874 7473686 7547719 7790704 7795293 8052994 ELTROMBOPAG OLAMINE - PROMACTA N022291 003 6280959 7160870 7332481 7452874 7473686 7547719 7790704 7795293 8062665

U-334

26, 2016 29, 2017

DS

DP

U-876

26, 2016 29, 2017

DS

DP

U-876

Oct Dec May May May Jul May May Aug

30, 08, 24, 24, 24, 13, 24, 21, 01,

2018 2021 2021 2021 2021 2025 2021 2023 2027

DS DS DS DS DS

DP DP DP DP DP

U-930 U-930 U-930 U-930 U-930 U-930 U-930 U-930

NCE ODE

Nov Nov

20, 2013 20, 2015

DP

Oct Dec May May May Jul May May Aug

30, 08, 24, 24, 24, 13, 24, 21, 01,

2018 2021 2021 2021 2021 2025 2021 2023 2027

DS DS DS DS DS

DP DP DP DP DP

U-930 U-930 U-930 U-930 U-930 U-930 U-930 U-930

NCE ODE

Nov Nov

20, 2013 20, 2015

DP

Oct Dec May May May Jul May May Aug

30, 08, 24, 24, 24, 13, 24, 21, 01,

2018 2021 2021 2021 2021 2025 2021 2023 2027

DS DS DS DS DS

DP DP DP DP DP

U-930 U-930 U-930 U-930 U-930 U-930 U-930 U-930

NCE ODE

Nov Nov

20, 2013 20, 2015

DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

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PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DS DS DS DS DS DP DP DP DP DP U-930 U-930 U-930 U-930 U-930 U-930 U-930 U-930

EXCLUSIVITY CODE(S)
NCE ODE

ELTROMBOPAG OLAMINE - PROMACTA N022291 004 6280959 7160870 7332481 7452874 7473686 7547719 7790704 7795293 8071129

Oct Dec May May May Jul May May Aug

30, 08, 24, 24, 24, 13, 24, 21, 01,

2018 2021 2021 2021 2021 2025 2021 2023 2027

Nov Nov

20, 2013 20, 2015

DP

EMEDASTINE DIFUMARATE - EMADINE N020706 001 5441958 Dec EMTRICITABINE - EMTRIVA N021500 001 5814639 5814639*PED 5914331 5914331*PED 6642245 6642245 6642245*PED 6703396 6703396*PED EMTRICITABINE - EMTRIVA N021896 001 5814639 5814639*PED 5914331 5914331*PED 6642245 6642245*PED 6703396 6703396*PED

08, 2013

U-404

Sep Mar Jul Jan Nov Nov May Mar Sep

29, 29, 02, 02, 04, 04, 04, 09, 09,

2015 2016 2017 2018 2020 2020 2021 2021 2021

DS DS

DP

U-257 U-541 DS DP

Sep Mar Jul Jan Nov May Mar Sep

29, 29, 02, 02, 04, 04, 09, 09,

2015 2016 2017 2018 2020 2021 2021 2021

DS DS

DP

U-257 DS DP

EMTRICITABINE; RILPIVIRINE; TENOFOVIR DISOPROXIL FUMARATE - COMPLERA DS DP N202123 001 5814639 Sep 29, 2015 Mar 29, 2016 5814639*PED Jul 02, 2017 5914331 DS Jan 02, 2018 5914331*PED Jul 25, 2017 DS U-257 5922695 Jan 25, 2018 5922695*PED Jul 25, 2017 DS DP U-257 5935946 Jan 25, 2018 5935946*PED DS DP Jul 25, 2017 5977089 U-257 Jan 25, 2018 5977089*PED U-257 Jul 25, 2017 6043230 Jan 25, 2018 6043230*PED U-257 Nov 04, 2020 6642245 May 04, 2021 6642245*PED Mar 09, 2021 DS DP 6703396 Sep 09, 2021 6703396*PED Feb 26, 2021 DS DP 6838464 Dec 20, 2019 DS DP 7067522 DS DP U-257 Apr 14, 2023 7125879

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 56 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)

EMTRICITABINE; TENOFOVIR DISOPROXIL N021752 001 5814639 Sep 5814639*PED Mar 5914331 Jul 5914331*PED Jan 5922695 Jul 5922695 Jul 5922695 Jul 5922695*PED Jan 5935946 Jul 5935946 Jul 5935946 Jul 5935946*PED Jan 5977089 Jul 5977089 Jul 5977089 Jul 5977089*PED Jan 6043230 Jul 6043230 Jul 6043230 Jul 6043230*PED Jan 6642245 Nov 6642245 Nov 6642245 Nov 6642245*PED May 6703396 Mar 6703396*PED Sep ENFUVIRTIDE - FUZEON N021481 001 5464933 6133418 6475491 ENOXAPARIN SODIUM - LOVENOX N020164 009 5389618 RE38743

FUMARATE - TRUVADA 29, 2015 DS DP 29, 2016 DS DP U-248 02, 2017 DS 02, 2018 25, 2017 DS U-248 DS U-541 25, 2017 DS U-1170 25, 2017 25, 2018 DS DP U-541 25, 2017 25, 2017 DS DP U-248 DS DP U-1170 25, 2017 25, 2018 DS DP U-1170 25, 2017 DS DP U-541 25, 2017 25, 2017 DS DP U-248 25, 2018 DP U-248 25, 2017 DP U-1170 25, 2017 25, 2017 DP U-541 25, 2018 U-1170 04, 2020 U-248 04, 2020 U-541 04, 2020 04, 2021 DS DP 09, 2021 09, 2021

Jun Nov Jun

07, 2013 17, 2014 07, 2015

DS

DP U-248

Feb Feb

14, 2012 14, 2012

DS DS

DP DP

U-545 U-545

ENOXAPARIN SODIUM - LOVENOX (PRESERVATIVE FREE) DS N020164 001 5389618 Feb 14, 2012 DS RE38743 Feb 14, 2012 ENOXAPARIN SODIUM - LOVENOX (PRESERVATIVE FREE) DS N020164 002 5389618 Feb 14, 2012 RE38743 Feb 14, 2012 DS ENOXAPARIN SODIUM - LOVENOX (PRESERVATIVE FREE) DS N020164 003 5389618 Feb 14, 2012 RE38743 Feb 14, 2012 DS ENOXAPARIN SODIUM - LOVENOX (PRESERVATIVE FREE) N020164 004 5389618 Feb 14, 2012 DS DS RE38743 Feb 14, 2012 ENOXAPARIN SODIUM - LOVENOX (PRESERVATIVE FREE) DS N020164 005 5389618 Feb 14, 2012 DS RE38743 Feb 14, 2012 ENOXAPARIN SODIUM - LOVENOX (PRESERVATIVE FREE) DS N020164 006 5389618 Feb 14, 2012 DS RE38743 Feb 14, 2012 ENOXAPARIN SODIUM - LOVENOX (PRESERVATIVE FREE) DS N020164 007 5389618 Feb 14, 2012 DS RE38743 Feb 14, 2012 ENOXAPARIN SODIUM - LOVENOX (PRESERVATIVE FREE) N020164 008 5389618 Feb 14, 2012 DS DS RE38743 Feb 14, 2012

DP DP

U-545 U-545

DP DP

U-545
U-545
U-545
U-545

DP DP

DP DP

U-545 U-545

DP DP

U-545 U-545

DP DP

U-545 U-545

DP DP

U-545 U-545

DP DP

U-545 U-545

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 57 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DS DP U-219

EXCLUSIVITY CODE(S)

ENTACAPONE - COMTAN N020796 001 5446194 6599530 ENTECAVIR - BARACLUDE N021797 001 5206244 ENTECAVIR - BARACLUDE N021797 002 5206244 ENTECAVIR - BARACLUDE N021798 001 5206244

Oct Sep

19, 2013 14, 2018

Feb

21, 2015

DS

D-127

Oct

15, 2013

Feb

21, 2015

DS

D-127

Oct

15, 2013

Feb

21, 2015

DS

D-127

Oct

15, 2013

EPINASTINE HYDROCHLORIDE - ELESTAT N021565 001 7429602 Nov

29, 2020

U-765

EPINASTINE HYDROCHLORIDE - EPINASTINE HYDROCHLORIDE A090870 001 EPINEPHRINE - ADRENACLICK N020800 003 5665071 EPINEPHRINE - ADRENACLICK N020800 004 5665071 EPINEPHRINE - EPIPEN N019430 001 7449012 7794432 8048035 EPINEPHRINE - EPIPEN JR. N019430 002 7449012 7794432 8048035 EPINEPHRINE - TWINJECT 0.15 N020800 002 7297136 7621891 EPINEPHRINE - TWINJECT 0.3 N020800 001 7297136 7621891

PC DP

Oct

29, 2011

May

27, 2013

May

27, 2013

DP

Sep Sep Sep

11, 2025 11, 2025 11, 2025

DP DP DP

Sep Sep Sep

11, 2025 11, 2025 11, 2025

DP DP DP

Jan Feb

18, 2025 04, 2025

DP DP

Jan Feb

18, 2025 04, 2025

DP DP TOPICAL SYSTEM KIT DS DP DS DP DS DP DS DP DS DP DS DP DP

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE - LIDOSITE N021504 001 5246418 Sep 30, 2013 Sep 30, 2013 5873850 Sep 30, 2013 6377847 Sep 30, 2013 6385488 Jun 30, 2020 6629968 Jun 29, 2021 6635045 Sep 30, 2013 6862473

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 58 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-3 U-537 U-467 U-3 U-537 U-537 U-3 DP U-537 U-587 DP DP U-664 U-664

EXCLUSIVITY CODE(S)
PED

EPLERENONE - INSPRA N021437 001 6410054 6410054 6410054*PED 6410524 6410524*PED 6495165 6495165 6495165*PED 6534093 6534093 6534093*PED 6558707 6558707*PED 6747020 6747020*PED 6863902 6863902*PED 7157101 7157101*PED EPLERENONE - INSPRA N021437 002 6410054 6410054 6410054*PED 6410524 6410524*PED 6495165 6495165 6495165*PED 6534093 6534093 6534093*PED 6558707 6558707*PED 6747020 6747020*PED 6863902 6863902*PED 7157101 7157101*PED EPLERENONE - INSPRA N021437 003 6410054 6410054 6410054*PED 6410524 6410524*PED 6495165 6495165 6495165*PED 6534093 6534093 6534093*PED 6558707 6558707*PED 6747020 6747020*PED 6863902 6863902*PED 7157101 7157101*PED EPROSARTAN MESYLATE - TEVETEN N020738 004 5656650 EPROSARTAN MESYLATE - TEVETEN N020738 005 5656650

Dec Dec Jun Nov May Dec Dec Jun Dec Dec Jun Dec Jun Nov May Apr Oct Dec Jun

08, 08, 08, 05, 05, 08, 08, 08, 08, 08, 08, 08, 08, 05, 05, 10, 10, 08, 08,

2019 2019 2020 2019 2020 2019 2019 2020 2019 2019 2020 2019 2020 2019 2020 2020 2020 2019 2020

Jul

31, 2011

Dec Dec Jun Nov May Dec Dec Jun Dec Dec Jun Dec Jun Nov May Apr Oct Dec Jun

08, 08, 08, 05, 05, 08, 08, 08, 08, 08, 08, 08, 08, 05, 05, 10, 10, 08, 08,

2019 2019 2020 2019 2020 2019 2019 2020 2019 2019 2020 2019 2020 2019 2020 2020 2020 2019 2020

U-3 U-537 U-467 U-3 U-537 U-3 U-537 DP U-537 U-587 DP DP U-664 U-664

PED

Jul

31, 2011

Dec Dec Jun Nov May Dec Dec Jun Dec Dec Jun Dec Jun Nov May Apr Oct Dec Jun

08, 08, 08, 05, 05, 08, 08, 08, 08, 08, 08, 08, 08, 05, 05, 10, 10, 08, 08,

2019 2019 2020 2019 2020 2019 2019 2020 2019 2019 2020 2019 2020 2019 2020 2020 2020 2019 2020

U-3 U-537 U-467 U-3 U-537 U-3 U-537 DP U-537 U-587 DP DP U-664 U-664

Aug

12, 2014

U-3

Aug

12, 2014

U-3

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 59 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-3

EXCLUSIVITY CODE(S)

EPROSARTAN MESYLATE - TEVETEN N020738 006 5656650

Aug

12, 2014

EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE - TEVETEN HCT U-3 N021268 001 5656650 Aug 12, 2014 EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE - TEVETEN HCT U-3 N021268 002 5656650 Aug 12, 2014 EPTIFIBATIDE - INTEGRILIN N020718 001 5686570 5747447 5756451 5807825 5968902 EPTIFIBATIDE - INTEGRILIN N020718 002 5686570 5747447 5756451 5807825 5968902 ERIBULIN MESYLATE - HALAVEN N201532 001 6214865 6469182 7470720

Nov May Nov Sep Jun

11, 05, 11, 15, 02,

2014 2015 2014 2015 2015

U-244 U-453

Nov May Nov Sep Jun

11, 05, 11, 15, 02,

2014 2015 2014 2015 2015

U-244 U-453

Jun Jun Jun

16, 2019 16, 2019 16, 2019

DS U-1096 DP

NCE

Nov

15, 2015

ERLOTINIB HYDROCHLORIDE - TARCEVA N021743 001 5747498 Nov 6900221 Nov 6900221 Nov 6900221 Nov 7087613 Nov 7087613 Nov RE41065 Nov ERLOTINIB HYDROCHLORIDE - TARCEVA N021743 002 5747498 Nov 6900221 Nov 6900221 Nov 6900221 Nov 7087613 Nov 7087613 Nov RE41065 Nov ERLOTINIB HYDROCHLORIDE - TARCEVA N021743 003 5747498 Nov 6900221 Nov 6900221 Nov 6900221 Nov 7087613 Nov 7087613 Nov RE41065 Nov ERTAPENEM SODIUM - INVANZ N021337 001 5478820 5478820*PED 5652233 5652233*PED 5952323 5952323*PED 7342005 7342005*PED

08, 09, 09, 09, 09, 09, 08,

2018 2020 2020 2020 2020 2020 2018

DS DS DS DS

DP DP DP DP

U-659 U-875 U-659 U-1046 U-659 U-1045

I-624 M-79

Apr Sep

16, 2013 19, 2011

DS

DP

08, 09, 09, 09, 09, 09, 08,

2018 2020 2020 2020 2020 2020 2018

DS DS DS DS

DP DP DP DP

U-659 U-875 U-659 U-1046 U-659 U-1045

I-624 M-79

Apr Sep

16, 2013 19, 2011

DS

DP

08, 09, 09, 09, 09, 09, 08,

2018 2020 2020 2020 2020 2020 2018

DS DS DS DS

DP DP DP DP

U-659 U-875 U-1046 U-659 U-659 U-1045

I-624 M-79

Apr Sep

16, 2013 19, 2011

DS

DP

Nov May Feb Aug May Nov Feb Aug

21, 21, 02, 02, 15, 15, 02, 02,

2015 2016 2013 2013 2017 2017 2013 2013

DS DS

DP DP DP DP

U-160 U-160

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 60 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DS DS DP DP DP DP

EXCLUSIVITY CODE(S)
NPP

ESCITALOPRAM OXALATE - LEXAPRO N021323 001 6916941 6916941*PED 7420069 7420069*PED RE34712 RE34712*PED ESCITALOPRAM OXALATE - LEXAPRO N021323 002 6916941 6916941*PED 7420069 7420069*PED RE34712 RE34712*PED ESCITALOPRAM OXALATE - LEXAPRO N021323 003 6916941 6916941*PED 7420069 7420069*PED RE34712 RE34712*PED

Aug Feb Aug Feb Sep Mar

12, 12, 12, 12, 14, 14,

2022 2023 2022 2023 2011 2012

Mar

19, 2012

DS

Aug Feb Aug Feb Sep Mar

12, 12, 12, 12, 14, 14,

2022 2023 2022 2023 2011 2012

DS DS

DP DP DP DP

NPP

Mar

19, 2012

DS

Aug Feb Aug Feb Sep Mar

12, 12, 12, 12, 14, 14,

2022 2023 2022 2023 2011 2012

DS DS

DP DP DP DP

NPP

Mar

19, 2012

DS

ESCITALOPRAM OXALATE - LEXAPRO N021365 001 RE34712 Sep Mar RE34712*PED ESMOLOL HYDROCHLORIDE - BREVIBLOC N019386 006 6310094 Jan 6310094*PED Jul 6528540 Jan 6528540*PED Jul ESMOLOL HYDROCHLORIDE - BREVIBLOC N019386 007 6310094 Jan 6310094*PED Jul 6528540 Jan 6528540*PED Jul

14, 2011 14, 2012

DS

DP

NPP

Mar

19, 2012

12, 12, 12, 12,

2021 2021 2021 2021

12, 12, 12, 12,

2021 2021 2021 2021

ESMOLOL HYDROCHLORIDE - BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER N019386 005 6310094 Jan 12, 2021 6310094*PED Jul 12, 2021 6528540 Jan 12, 2021 6528540*PED Jul 12, 2021 ESMOLOL HYDROCHLORIDE - BREVIBLOC IN PLASTIC CONTAINER N019386 004 6310094 Jan 12, 2021 6310094*PED Jul 12, 2021 6528540 Jan 12, 2021 6528540*PED Jul 12, 2021

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 61 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DP DP DP DP DP DP DP DP DP DS DS DS U-373 U-729 U-770 U-373 U-729 U-770 U-373 U-373 U-729 U-770 U-373 U-373 U-729 U-770 U-373 U-373

EXCLUSIVITY CODE(S)

ESOMEPRAZOLE MAGNESIUM - NEXIUM N021153 001 5690960 Nov 5690960 Nov 5690960 Nov 5690960*PED May Feb 5714504 Feb 5714504 Feb 5714504 Aug 5714504*PED May 5877192 May 5877192 May 5877192 Nov 5877192*PED May 5900424 May 5900424 May 5900424 Nov 5900424*PED Oct 6147103 Apr 6147103*PED Oct 6166213 Apr 6166213*PED Oct 6191148 Apr 6191148*PED May 6369085 May 6369085 Nov 6369085*PED Nov 6428810 Nov 6428810 Nov 6428810 May 6428810*PED May 6875872 Nov 6875872*PED May 7411070 Nov 7411070*PED ESOMEPRAZOLE MAGNESIUM - NEXIUM N021153 002 5690960 Nov 5690960 Nov 5690960 Nov 5690960*PED May Feb 5714504 Feb 5714504 Feb 5714504 Aug 5714504*PED May 5877192 May 5877192 May 5877192 Nov 5877192*PED May 5900424 May 5900424 May 5900424 Nov 5900424*PED Oct 6147103 Apr 6147103*PED Oct 6166213 Apr 6166213*PED Oct 6191148 Apr 6191148*PED May 6369085 May 6369085 Nov 6369085*PED Nov 6428810 Nov 6428810 Nov 6428810 May 6428810*PED May 6875872 Nov 6875872*PED May 7411070 Nov 7411070*PED

25, 25, 25, 25, 03, 03, 03, 03, 27, 27, 27, 27, 04, 04, 04, 04, 09, 09, 09, 09, 09, 09, 25, 25, 25, 03, 03, 03, 03, 27, 27, 25, 25,

2014 2014 2014 2015 2015 2015 2015 2015 2014 2014 2014 2014 2016 2016 2016 2016 2018 2019 2018 2019 2018 2019 2018 2018 2018 2019 2019 2019 2020 2014 2014 2018 2018

DS DS

DP DP DP DP DP

U-770 U-729 U-770 U-469 U-729 U-469

DS DS

25, 25, 25, 25, 03, 03, 03, 03, 27, 27, 27, 27, 04, 04, 04, 04, 09, 09, 09, 09, 09, 09, 25, 25, 25, 03, 03, 03, 03, 27, 27, 25, 25,

2014 2014 2014 2015 2015 2015 2015 2015 2014 2014 2014 2014 2016 2016 2016 2016 2018 2019 2018 2019 2018 2019 2018 2018 2018 2019 2019 2019 2020 2014 2014 2018 2018

DP DP DP DP DP DP DP DP DP DS DS DS

U-770 U-373 U-729 U-373 U-770 U-729 U-373 U-373 U-770 U-729 U-373 U-373 U-770 U-373 U-729 U-373

DS DS

DP DP DP DP DP

U-729 U-770 U-770 U-729 U-469 U-469

DS DS

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 62 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DP DP DP DP DP DP U-1207 U-729 U-773 U-729 U-773 U-1207 U-773 U-729 DS DS DS DS DS DS DP DP DP DP DP DP DS DS U-1207 U-729 U-773 U-729 U-773 U-1207 U-729 U-773 U-1207

EXCLUSIVITY CODE(S)
M-86 PED PED

ESOMEPRAZOLE MAGNESIUM - NEXIUM Nov N021957 001 5690960 Nov 5690960 Nov 5690960 May 5690960*PED Feb 5714504 Feb 5714504 Feb 5714504 Aug 5714504*PED May 5877192 May 5877192 Nov 5877192*PED May 5900424 May 5900424 May 5900424 Nov 5900424*PED May 6369085 May 6369085 May 6369085 Nov 6369085*PED Nov 6428810 Nov 6428810 Nov 6428810 May 6428810*PED May 6875872 Nov 6875872*PED May 7411070 Nov 7411070*PED ESOMEPRAZOLE MAGNESIUM - NEXIUM Nov N021957 002 5690960 Nov 5690960 Nov 5690960 May 5690960*PED Feb 5714504 Feb 5714504 Feb 5714504 Aug 5714504*PED May 5877192 May 5877192 Nov 5877192*PED May 5900424 May 5900424 May 5900424 Nov 5900424*PED May 6369085 May 6369085 May 6369085 Nov 6369085*PED Nov 6428810 Nov 6428810 Nov 6428810 May 6428810*PED May 6875872 Nov 6875872*PED May 7411070 Nov 7411070*PED

25, 25, 25, 25, 03, 03, 03, 03, 27, 27, 27, 04, 04, 04, 04, 25, 25, 25, 25, 03, 03, 03, 03, 27, 27, 25, 25,

2014 2014 2014 2015 2015 2015 2015 2015 2014 2014 2014 2016 2016 2016 2016 2018 2018 2018 2018 2019 2019 2019 2020 2014 2014 2018 2018

Jun Aug Dec

18, 2012 27, 2011 18, 2012

25, 25, 25, 25, 03, 03, 03, 03, 27, 27, 27, 04, 04, 04, 04, 25, 25, 25, 25, 03, 03, 03, 03, 27, 27, 25, 25,

2014 2014 2014 2015 2015 2015 2015 2015 2014 2014 2014 2016 2016 2016 2016 2018 2018 2018 2018 2019 2019 2019 2020 2014 2014 2018 2018

DP DP DP DP DP DP

U-1207 U-729 U-773 U-1207 U-729 U-773 U-729 U-773

M-86 PED PED

Jun Aug Dec

18, 2012 27, 2011 18, 2012

DS DS DS DS DS DS DP DP DP DP DP DP DS DS

U-1207 U-773 U-729 U-1207 U-729 U-773 U-1207 U-729 U-773

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 63 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DP DP U-858 U-858 U-858 DS DS DP DP DS DS U-858 U-858 U-858

EXCLUSIVITY CODE(S)
M-86 PED PED

ESOMEPRAZOLE MAGNESIUM - NEXIUM Nov N022101 001 5690960 May 5690960*PED Feb 5714504 Aug 5714504*PED May 5877192 Nov 5877192*PED May 5900424 Nov 5900424*PED May 6369085 Nov 6369085*PED Nov 6428810 May 6428810*PED May 6875872 Nov 6875872*PED May 7411070 Nov 7411070*PED

25, 25, 03, 03, 27, 27, 04, 04, 25, 25, 03, 03, 27, 27, 25, 25,

2014 2015 2015 2015 2014 2014 2016 2016 2018 2018 2019 2020 2014 2014 2018 2018

Jun Dec Aug

18, 2012 18, 2012 27, 2011

ESOMEPRAZOLE MAGNESIUM; NAPROXEN - VIMOVO Feb 03, 2015 N022511 001 5714504 Aug 03, 2015 5714504*PED May 04, 2016 5900424 Nov 04, 2016 5900424*PED May 25, 2018 6369085 Nov 25, 2018 6369085*PED May 27, 2014 6875872 Nov 27, 2014 6875872*PED Feb 28, 2023 6926907 May 25, 2018 7411070 Nov 25, 2018 7411070*PED Oct 13, 2018 7745466 ESOMEPRAZOLE MAGNESIUM; NAPROXEN - VIMOVO N022511 002 5714504 Feb 03, 2015 5714504*PED Aug 03, 2015 5900424 May 04, 2016 Nov 04, 2016 5900424*PED May 25, 2018 6369085 6369085*PED Nov 25, 2018 6875872 May 27, 2014 Nov 27, 2014 6875872*PED Feb 28, 2023 6926907 May 25, 2018 7411070 Nov 25, 2018 7411070*PED Oct 13, 2018 7745466 ESOMEPRAZOLE SODIUM - NEXIUM IV May N021689 001 5877192 Nov 5877192*PED May 6143771 ESOMEPRAZOLE SODIUM - NEXIUM IV N021689 002 5877192 May Nov 5877192*PED May 6143771 ESTRADIOL - ELESTRIN N021813 001 7198801 7470433 ESTRADIOL - EVAMIST N022014 001 6299900 6299900 6818226 6818226 6923983 6923983 6978945

DP DS DS DS DP DS DP DP

U-1053 U-1053 U-1053

NC

Apr

30, 2013

U-1052 U-1053 U-1053

DP DS DS DS DP DS DP DP

U-1053 U-1053 U-1053

NC

Apr

30, 2013

U-1052 U-1053 U-1053

27, 2014 27, 2014 27, 2014

U-643 DP U-643

27, 2014 27, 2014 27, 2014

U-643 DP U-643

Jun Aug

25, 2022 03, 2021

DP DP

Feb Feb Feb Feb Feb Feb Nov

19, 19, 19, 19, 19, 19, 30,

2017 2017 2017 2017 2017 2017 2021

DP DP DP DP DP DP DP

U-889 U-888 U-888 U-889 U-888 U-889

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 64 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DP DP U-594 U-594

EXCLUSIVITY CODE(S)

ESTRADIOL - MENOSTAR N021674 001 5891868 6692763 ESTRADIOL - VAGIFEM N020908 002 7018992 ESTRADIOL - VIVELLE-DOT N020538 005 5474783 5656286 5958446 6024976 ESTRADIOL - VIVELLE-DOT N020538 006 5474783 5656286 5958446 6024976 ESTRADIOL - VIVELLE-DOT N020538 007 5474783 5656286 5958446 6024976 ESTRADIOL - VIVELLE-DOT N020538 008 5474783 5656286 5958446 6024976 ESTRADIOL - VIVELLE-DOT N020538 009 5474783 5656286 5958446 6024976 ESTRADIOL ACETATE - FEMRING N021367 001 5855906 ESTRADIOL ACETATE - FEMRING N021367 002 5855906 ESTRADIOL ACETATE - FEMTRACE N021633 001 6962908 7572779 7799771 ESTRADIOL ACETATE - FEMTRACE N021633 002 6962908 7572779 7799771 ESTRADIOL ACETATE - FEMTRACE N021633 003 6962908 7572779 7799771

Nov Nov

21, 2017 21, 2017

Sep

17, 2022

U-1023

D-122

Nov

25, 2012

Dec Aug Dec Jan

12, 12, 12, 07,

2012 2014 2012 2014

Dec Aug Dec Jan

12, 12, 12, 07,

2012 2014 2012 2014

Dec Aug Dec Jan

12, 12, 12, 07,

2012 2014 2012 2014

Dec Aug Dec Jan

12, 12, 12, 07,

2012 2014 2012 2014

Dec Aug Dec Jan

12, 12, 12, 07,

2012 2014 2012 2014

DP DP DP DP

Dec

19, 2015

U-508

Dec

19, 2015

U-508

Dec Oct Dec

21, 2021 02, 2025 21, 2021

DP U-904 DP

Dec Oct Dec

21, 2021 02, 2025 21, 2021

DP U-904 DP

Dec Oct Dec

21, 2021 02, 2025 21, 2021

DP U-904 DP

ESTRADIOL HEMIHYDRATE - ESTRASORB N021371 001 5629021 Jan

31, 2015

DP

ESTRADIOL; LEVONORGESTREL - CLIMARA PRO N021258 001 5676968 Oct 14, 2014 ESTRADIOL; NORETHINDRONE ACETATE - COMBIPATCH Dec 12, 2012 N020870 001 5474783 Aug 12, 2014 5656286 Dec 12, 2012 5958446 Jan 07, 2014 6024976

DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 65 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)

ESTRADIOL; NORETHINDRONE ACETATE - COMBIPATCH N020870 002 5474783 Dec 12, 2012 5656286 Aug 12, 2014 Dec 12, 2012 5958446 Jan 07, 2014 6024976 ESTRADIOL; NORGESTIMATE - PREFEST N021040 001 5382573 Jan 6747019 Mar 7320970 Mar ESTROGENS, CONJUGATED - PREMARIN N020216 001 ESTROGENS, CONJUGATED SYNTHETIC A - CENESTIN N020992 001 5908638 Jul 26, 2015 ESTROGENS, CONJUGATED SYNTHETIC A - CENESTIN N020992 002 5908638 Jul 26, 2015 ESTROGENS, CONJUGATED SYNTHETIC A - CENESTIN N020992 003 5908638 Jul 26, 2015 ESTROGENS, CONJUGATED SYNTHETIC A - CENESTIN N020992 004 5908638 Jul 26, 2015 ESTROGENS, CONJUGATED SYNTHETIC A - CENESTIN N020992 005 5908638 Jul 26, 2015 ESTROGENS, CONJUGATED SYNTHETIC A - SYNTHETIC CONJUGATED ESTROGENS A N021788 001 ESTROGENS, CONJUGATED SYNTHETIC B N021443 001 6660726 Mar 6660726 Mar 6855703 Feb 6855703 Feb ESTROGENS, CONJUGATED SYNTHETIC B N021443 002 6660726 Mar 6660726 Mar 6855703 Feb 6855703 Feb ESTROGENS, CONJUGATED SYNTHETIC B N021443 003 6660726 Mar 6660726 Mar 6855703 Feb 6855703 Feb ESTROGENS, CONJUGATED SYNTHETIC B N021443 004 6660726 Mar 6660726 Mar 6855703 Feb 6855703 Feb ESTROGENS, CONJUGATED SYNTHETIC B N021443 005 6660726 Mar 6660726 Mar 6855703 Feb 6855703 Feb ENJUVIA 08, 2021 08, 2021 12, 2021 12, 2021 ENJUVIA 08, 2021 08, 2021 12, 2021 12, 2021 ENJUVIA 08, 2021 08, 2021 12, 2021 12, 2021 ENJUVIA 08, 2021 08, 2021 12, 2021 12, 2021 ENJUVIA 08, 2021 08, 2021 12, 2021 12, 2021

17, 2012 20, 2020 30, 2020

DP

U-311 U-844

I-579 DP

Nov

07, 2011

NP

Nov

28, 2011

DS DS DS DS

DP DP DP DP

U-904 U-905 U-904 U-905

DS DS DS DS

DP DP DP DP

U-904 U-905 U-905 U-904

DS DS DS DS

DP DP DP DP

U-905 U-904 U-904 U-905

DS DS DS DS

DP DP DP DP

U-904 U-905 U-904 U-905

DS DS DS DS

DP DP DP DP

U-905 U-904 U-904 U-905

ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE - PREMPHASE 14/14 N020527 002 5547948 Jan 17, 2015 ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE - PREMPRO N020527 001 5547948 Jan 17, 2015 ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE - PREMPRO N020527 003 5547948 Jan 17, 2015

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 66 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)

ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE - PREMPRO N020527 004 5547948 Jan 17, 2015 ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE - PREMPRO N020527 005 5547948 Jan 17, 2015 ESZOPICLONE - LUNESTA N021476 001 6319926 6444673 6864257 7381724 ESZOPICLONE - LUNESTA N021476 002 6319926 6444673 6864257 7381724 ESZOPICLONE - LUNESTA N021476 003 6319926 6444673 6864257 7381724

Jan Feb Aug Jan

16, 14, 30, 16,

2012 2014 2012 2012

U-620 DS DS DP DP U-629 U-629

Jan Feb Aug Jan

16, 14, 30, 16,

2012 2014 2012 2012

U-620 DS DS DP DP U-629 U-629

Jan Feb Aug Jan

16, 14, 30, 16,

2012 2014 2012 2012

U-620 DS DS DP DP U-629 U-629

ETHINYL ESTRADIOL; ETONOGESTREL - NUVARING N021187 001 5989581 Apr 08, 2018 ETHINYL ESTRADIOL; LEVONORGESTREL N022262 001 7615545 Jun 7855190 Dec 7858605 Jun LOSEASONIQUE 15, 2023 05, 2028 23, 2023

U-1 U-1 DP

NP

Oct

24, 2011

ETHINYL ESTRADIOL; LEVONORGESTREL - LYBREL N021864 001 6500814 Sep 03, 2018

U-1

ETHINYL ESTRADIOL; LEVONORGESTREL - PREVEN EMERGENCY CONTRACEPTIVE KIT N020946 001 6156742 Dec 05, 2020 U-374 ETHINYL ESTRADIOL; LEVONORGESTREL - SEASONALE N021544 001 5898032 Jun 23, 2017 RE39861 Jun 23, 2017 ETHINYL ESTRADIOL; LEVONORGESTREL N021840 001 7320969 Jan 7615545 Jun 7855190 Dec 7858605 Jun SEASONIQUE 30, 2024 15, 2023 05, 2028 23, 2023

U-1 U-828

U-828 U-1 U-1 DP

ETHINYL ESTRADIOL; NORELGESTROMIN - ORTHO EVRA N021180 001 5876746 Nov 20, 2015 5972377 Jun 07, 2015 ETHINYL ESTRADIOL; NORETHINDRONE - FEMCON FE N021490 001 6667050 Apr 06, 2019

DP

U-514 U-514

DP

U-1

ETHINYL ESTRADIOL; NORETHINDRONE - NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE A078965 001 PC Sep ETHINYL ESTRADIOL; NORETHINDRONE - NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE N022573 001 5552394 Jul 22, 2014 U-828 NP Dec DP U-828 6667050 Apr 06, 2019 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE - LO LOESTRIN FE N022501 001 5552394 Jul 22, 2014 U-1090 U-1090 7704984 Feb 02, 2029 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE - LOESTRIN 24 FE N021871 001 5552394 Jul 22, 2014 U-1

21, 2011

22, 2013

NP

Oct

21, 2013

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 67 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-112

EXCLUSIVITY CODE(S)

ETHINYL ESTRADIOL; NORGESTIMATE - ORTHO TRI-CYCLEN LO N021241 001 6214815 Jun 09, 2019 6214815*PED Dec 09, 2019 ETRAVIRINE - INTELENCE N022187 001 6878717 6878717 7037917 7037917 7887845 8003789 ETRAVIRINE - INTELENCE N022187 002 6878717 7037917 7887845 8003789 EVEROLIMUS - AFINITOR N022334 001 5665772 6004973 7297703

Nov Nov Dec Dec Mar Nov

05, 05, 13, 13, 25, 01,

2019 2019 2020 2020 2019 2019

DS DS

DP DP DP

U-256 U-1016 U-256 U-1016

NCE

Jan

18, 2013

Nov Dec Mar Nov

05, 13, 25, 01,

2019 2020 2019 2019

DS

DP DP

U-1016 U-1016

NCE

Jan

18, 2013

Sep Jul Dec

09, 2019 12, 2016 06, 2019

DS

DP DP DP

I-638 I-630 NCE ODE ODE

May Oct Mar May Oct

05, 29, 30, 05, 29,

2014 2013 2014 2018 2017

EVEROLIMUS - AFINITOR N022334 002 5665772 6004973 7297703

Sep Jul Dec

09, 2019 12, 2016 06, 2019

DS

DP DP DP

I-638 I-630 NCE ODE ODE

May Oct Mar May Oct

05, 29, 30, 05, 29,

2014 2013 2014 2018 2017

EVEROLIMUS - AFINITOR N022334 003 5665772

Sep

09, 2019

I-638 I-630 NCE ODE ODE DS DP DP DP U-1049 U-1049 U-1049 U-1049 U-1049

May Oct Mar May Oct

05, 29, 30, 05, 29,

2014 2013 2014 2018 2017

EVEROLIMUS - ZORTRESS N021560 001 5665772 6004973 6239124 6440990 6455518 EVEROLIMUS - ZORTRESS N021560 002 5665772 6004973 6239124 6440990 6455518 EVEROLIMUS - ZORTRESS N021560 003 5665772 6004973 6239124 6440990 6455518

Sep Jul Aug Sep Jul

09, 12, 11, 24, 29,

2019 2016 2017 2013 2017

NP NCE

Apr Mar

20, 2013 30, 2014

Sep Jul Aug Sep Jul

09, 12, 11, 24, 29,

2019 2016 2017 2013 2017

DS

DP DP DP

U-1049 U-1049 U-1049 U-1049 U-1049

NP NCE

Apr Mar

20, 2013 30, 2014

Sep Jul Aug Sep Jul

09, 12, 11, 24, 29,

2019 2016 2017 2013 2017

DS

DP DP DP

U-1049 U-1049 U-1049 U-1049 U-1049

NP NCE

Apr Mar

20, 2013 30, 2014

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 68 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-653 U-1108 U-656 U-654 DP U-687 DP DP U-1074

EXCLUSIVITY CODE(S)

EXENATIDE SYNTHETIC - BYETTA N021773 001 5424286 5424286 6858576 6872700 6902744 6956026 7297761 7521423 7741269 EXENATIDE SYNTHETIC - BYETTA N021773 002 5424286 5424286 6858576 6872700 6902744 6956026 7297761 7521423 7741269 EZETIMIBE - ZETIA N021445 001 5846966 5846966 5846966 5846966*PED 7030106 7030106*PED 7612058 7612058 7612058*PED RE37721 RE37721*PED RE42461 RE42461 RE42461*PED

Dec Dec Jan Jan Jan Jan Oct Oct Jan

01, 01, 06, 14, 14, 07, 15, 15, 07,

2016 2016 2017 2020 2020 2018 2017 2017 2018

Dec Dec Jan Jan Jan Jan Oct Oct Jan

01, 01, 06, 14, 14, 07, 15, 15, 07,

2016 2016 2017 2020 2020 2018 2017 2017 2018

U-1108 U-653 U-656 U-654 DP U-687 DP DP U-1074

Sep Sep Sep Mar Jan Jul Jan Jan Jul Oct Apr Oct Oct Apr

21, 21, 21, 21, 25, 25, 25, 25, 25, 25, 25, 25, 25, 25,

2013 2013 2013 2014 2022 2022 2022 2022 2022 2016 2017 2016 2016 2017

U-1172 U-474 U-473 DP U-1027 U-1173 DS DS DS DP DP DP U-473 U-1173 U-473

PED

Dec

05, 2011

EZETIMIBE; SIMVASTATIN - VYTORIN Sep N021687 001 5846966 Sep 5846966 Mar 5846966*PED Oct RE37721 Apr RE37721*PED Oct RE42461 Apr RE42461*PED EZETIMIBE; SIMVASTATIN - VYTORIN N021687 002 5846966 Sep Sep 5846966 Mar 5846966*PED Oct RE37721 Apr RE37721*PED Oct RE42461 Apr RE42461*PED EZETIMIBE; SIMVASTATIN - VYTORIN N021687 003 5846966 Sep Sep 5846966 Mar 5846966*PED Oct RE37721 Apr RE37721*PED Oct RE42461 Apr RE42461*PED

21, 21, 21, 25, 25, 25, 25,

2013 2013 2014 2016 2017 2016 2017

DP DP DS DS DP DP

U-473 U-593 U-473 U-473 Y Y

PED

Dec

05, 2011

21, 21, 21, 25, 25, 25, 25,

2013 2013 2014 2016 2017 2016 2017

DP DP DS DS DP DP

U-473 U-593 U-473 U-473 Y Y

PED

Dec

05, 2011

21, 21, 21, 25, 25, 25, 25,

2013 2013 2014 2016 2017 2016 2017

DP DP DS DS DP DP

U-473 U-593 U-473 U-473 Y Y

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 69 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DP DP DS DS DP DP U-473 U-593 U-473 U-473

EXCLUSIVITY CODE(S)
PED

EZETIMIBE; SIMVASTATIN - VYTORIN Sep N021687 004 5846966 Sep 5846966 Mar 5846966*PED Oct RE37721 Apr RE37721*PED Oct RE42461 Apr RE42461*PED EZOGABINE - POTIGA N022345 001 EZOGABINE - POTIGA N022345 002 EZOGABINE - POTIGA N022345 003 EZOGABINE - POTIGA N022345 004 FAMCICLOVIR - FAMVIR N020363 001 5840763 5840763*PED 5866581 5866581*PED 5916893 5916893*PED 6124304 6124304*PED FAMCICLOVIR - FAMVIR N020363 002 5840763 5840763*PED 5866581 5866581*PED 5916893 5916893*PED 6124304 6124304*PED FAMCICLOVIR - FAMVIR N020363 003 5840763 5840763*PED 5866581 5866581*PED 5916893 5916893*PED 6124304 6124304*PED FAMOTIDINE - FLUXID N021712 001 6024981 6221392 FAMOTIDINE - FLUXID N021712 002 6024981 6221392 FAMOTIDINE - PEPCID AC N020325 001 5854267 5854267*PED FAMOTIDINE - PEPCID AC N020801 001 5667794 5667794*PED 5854267 5854267*PED

21, 21, 21, 25, 25, 25, 25,

2013 2013 2014 2016 2017 2016 2017

Dec

05, 2011

Y Y

NCE

Jun

10, 2016

NCE

Jun

10, 2016

NCE

Jun

10, 2016

NCE Sep Mar Oct Apr Sep Mar Oct Apr 01, 01, 04, 04, 01, 01, 04, 04, 2015 2016 2014 2015 2015 2016 2014 2015 U-96 U-96 U-96 U-96

Jun

10, 2016

M-98 M-54 PED

Jan Dec Jun

31, 2014 24, 2012 24, 2013

Sep Mar Oct Apr Sep Mar Oct Apr

01, 01, 04, 04, 01, 01, 04, 04,

2015 2016 2014 2015 2015 2016 2014 2015

U-96 U-96 U-96 U-96

M-98 M-54 PED

Jan Dec Jun

31, 2014 24, 2012 24, 2013

Sep Mar Oct Apr Sep Mar Oct Apr

01, 01, 04, 04, 01, 01, 04, 04,

2015 2016 2014 2015 2015 2016 2014 2015

U-96 U-96 U-96 U-96

M-98 M-54 PED

Jan Dec Jun

31, 2014 24, 2012 24, 2013

Apr Apr

09, 2018 09, 2018

DP DP

Apr Apr

09, 2018 09, 2018

DP DP

Dec Jun

29, 2015 29, 2016

U-267 U-267

May Nov Dec Jun

02, 02, 29, 29,

2015 2015 2015 2016

Y U-267

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 70 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DP

EXCLUSIVITY CODE(S)

FAMOTIDINE - PEPCID AC N020801 002 6814978 6814978*PED

Aug Feb

26, 2021 26, 2022

FAMOTIDINE - PEPCID AC (GELTAB) N020902 001 5854267 Dec 5854267*PED Jun FAMOTIDINE; IBUPROFEN - DUEXIS N022519 001 8067033 Jul 8067451 Jul FEBUXOSTAT - ULORIC N021856 001 5614520 6225474 7361676 FEBUXOSTAT - ULORIC N021856 002 5614520 6225474 7361676

29, 2015 29, 2016

U-368 U-368

18, 2026 18, 2026

DP DP

NC U-1196

Apr

23, 2014

Mar Jun Mar

25, 2014 18, 2019 08, 2024

DS DS

DP DP

U-954

NCE

Feb

13, 2014

Mar Jun Mar

25, 2014 18, 2019 08, 2024

DS DS

DP DP

U-954

NCE

Feb

13, 2014

FENOFIBRATE - ANTARA (MICRONIZED) N021695 001 7101574 Aug 7863331 Aug 7863331 Aug FENOFIBRATE - ANTARA (MICRONIZED) N021695 003 7101574 Aug 7863331 Aug 7863331 Aug FENOFIBRATE - FENOGLIDE N022118 001 7658944 FENOFIBRATE - FENOGLIDE N022118 002 7658944 FENOFIBRATE - LIPOFEN N021612 001 5545628 FENOFIBRATE - LIPOFEN N021612 002 5545628 FENOFIBRATE - LIPOFEN N021612 003 5545628 FENOFIBRATE - TRICOR N021203 001 6074670 6277405 6589552 6652881 7037529 7041319 FENOFIBRATE - TRICOR N021203 003 6074670 6277405 6589552 6652881 7037529 7041319 FENOFIBRATE - TRICOR N021656 001 6277405 6375986 6652881 7037529 7041319 7276249 7320802

20, 2020 08, 2020 08, 2020

DS

DP U-1107 U-1106

20, 2020 08, 2020 08, 2020

DS

DP U-1106 U-1107

Dec

09, 2024

DP

Dec

09, 2024

DP

Jan

10, 2015

DP

U-701

Jan

10, 2015

DP

U-701

Jan

10, 2015

DP

U-701

Jan Jan Jan Jan Jan Jan

09, 09, 09, 09, 09, 09,

2018 2018 2018 2018 2018 2018

DP DP DP

Jan Jan Jan Jan Jan Jan

09, 09, 09, 09, 09, 09,

2018 2018 2018 2018 2018 2018

DP DP DP

Jan Sep Jan Jan Jan Feb Feb

09, 21, 09, 09, 09, 21, 21,

2018 2020 2018 2018 2018 2023 2023

DS DP DS DP DP DP U-847 U-615

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 71 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DS DP DS DP DP DP U-847 U-615

EXCLUSIVITY CODE(S)

FENOFIBRATE - TRICOR N021656 002 6277405 6375986 6652881 7037529 7041319 7276249 7320802 FENOFIBRATE - TRIGLIDE N021350 001 6696084 FENOFIBRATE - TRIGLIDE N021350 002 6696084 FENOFIBRIC ACID - FIBRICOR N022418 001 7569612 7741373 7741374 7741374 7915247 7915247 7915247 FENOFIBRIC ACID - FIBRICOR N022418 002 7569612 7741373 7741374 7741374 7915247 7915247 7915247 FENTANYL CITRATE - ABSTRAL N022510 001 6759059 6761910 7910132 FENTANYL CITRATE - ABSTRAL N022510 002 6759059 6761910 7910132 FENTANYL CITRATE - ABSTRAL N022510 003 6759059 6761910 7910132 FENTANYL CITRATE - ABSTRAL N022510 004 6759059 6761910 7910132 FENTANYL CITRATE - ABSTRAL N022510 005 6759059 6761910 7910132 FENTANYL CITRATE - ABSTRAL N022510 006 6759059 6761910 7910132 FENTANYL CITRATE - FENTORA N021947 001 6200604 6974590 7862832 7862833

Jan Sep Jan Jan Jan Feb Feb

09, 21, 09, 09, 09, 21, 21,

2018 2020 2018 2018 2018 2023 2023

Sep

11, 2021

DS

DP

U-680

Sep

11, 2021

DS

DP

U-680

Aug Aug Aug Aug Aug Aug Aug

20, 20, 20, 20, 20, 20, 20,

2027 2027 2027 2027 2027 2027 2027

U-1000 U-1059 U-1061 U-1060 U-1061 U-1059 U-1000

Aug Aug Aug Aug Aug Aug Aug

20, 20, 20, 20, 20, 20, 20,

2027 2027 2027 2027 2027 2027 2027

U-1000 U-1059 U-1061 U-1060 U-1061 U-1059 U-1000

Sep Sep Sep

24, 2019 24, 2019 24, 2019

DP DP DP

U-767 U-767 U-767

Sep Sep Sep

24, 2019 24, 2019 24, 2019

DP DP DP

U-767 U-767 U-767

Sep Sep Sep

24, 2019 24, 2019 24, 2019

DP DP DP

U-767 U-767 U-767

Sep Sep Sep

24, 2019 24, 2019 24, 2019

DP DP DP

U-767 U-767 U-767

Sep Sep Sep

24, 2019 24, 2019 24, 2019

DP DP DP

U-767 U-767 U-767

Sep Sep Sep

24, 2019 24, 2019 24, 2019

DP DP DP

U-767 U-767 U-767

Mar Mar Jun Jun

26, 26, 15, 15,

2019 2019 2028 2028

U-767 U-767 DP DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 72 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-767 U-767 DP DP

EXCLUSIVITY CODE(S)

FENTANYL CITRATE - FENTORA N021947 002 6200604 6974590 7862832 7862833 FENTANYL CITRATE - FENTORA N021947 003 6200604 6974590 7862832 7862833 FENTANYL CITRATE - FENTORA N021947 004 6200604 6974590 7862832 7862833 FENTANYL CITRATE - FENTORA N021947 005 6200604 6974590 7862832 7862833 FENTANYL CITRATE - FENTORA N021947 006 6200604 6974590 FENTANYL CITRATE - LAZANDA N022569 001 6432440 FENTANYL CITRATE - LAZANDA N022569 002 6432440 FENTANYL CITRATE - ONSOLIS N022266 001 6159498 7579019 FENTANYL CITRATE - ONSOLIS N022266 002 6159498 7579019 FENTANYL CITRATE - ONSOLIS N022266 003 6159498 7579019 FENTANYL CITRATE - ONSOLIS N022266 004 6159498 7579019 FENTANYL CITRATE - ONSOLIS N022266 005 6159498 7579019

Mar Mar Jun Jun

26, 26, 15, 15,

2019 2019 2028 2028

Mar Mar Jun Jun

26, 26, 15, 15,

2019 2019 2028 2028

U-767 U-767 DP DP

Mar Mar Jun Jun

26, 26, 15, 15,

2019 2019 2028 2028

U-767 U-767 DP DP

Mar Mar Jun Jun

26, 26, 15, 15,

2019 2019 2028 2028

U-767 U-767 DP DP

Mar Mar

26, 2019 26, 2019

U-767 U-767

Apr

20, 2018

DP

U-1169

NDF

Jun

30, 2014

Apr

20, 2018

DP

U-1169

NDF

Jun

30, 2014

Oct Jan

18, 2016 31, 2019

DP U-767

NP

Jul

16, 2012

Oct Jan

18, 2016 31, 2019

DP U-767

NP

Jul

16, 2012

Oct Jan

18, 2016 31, 2019

DP U-767

NP

Jul

16, 2012

Oct Jan

18, 2016 31, 2019

DP U-767

NP

Jul

16, 2012

Oct Jan

18, 2016 31, 2019

DP U-767

NP

Jul

16, 2012

FENTANYL HYDROCHLORIDE - IONSYS Dec N021338 001 5697896 Dec 5843014 Jan 6169920 Jun 6171294 Nov 6181963 Jan 6195582 Jun 6216033 Jun 6317629 Jun 6425892 Jun 6842640 Apr 6881208 Apr 6975902 Jun 7018370 Sep 7027859 Jun 7302293

16, 01, 02, 05, 02, 28, 05, 02, 05, 02, 19, 01, 05, 26, 05,

2014 2015 2018 2015 2019 2019 2015 2012 2015 2015 2022 2024 2015 2014 2015

DP DP DP U-736 DP DP DP DP DP U-736 DP U-736 DP DP U-736

U-736

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 73 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DS DS DS DP DP DP

EXCLUSIVITY CODE(S)
NP

FERUMOXYTOL - FERAHEME N022180 001 6599498 7553479 7871597

Mar Mar Mar

08, 2020 08, 2020 08, 2020

Jun

30, 2012

FESOTERODINE FUMARATE - TOVIAZ N022030 001 6858650 May May 7384980 Jun 7807715 May 7855230 May 7985772 FESOTERODINE FUMARATE - TOVIAZ May N022030 002 6858650 May 7384980 Jun 7807715 May 7855230 May 7985772

11, 11, 07, 11, 11,

2019 2019 2027 2019 2019

DS DS

DP DP DP

DS

U-913 U-913 U-913 U-913 U-913

NCE

Oct

31, 2013

11, 11, 07, 11, 11,

2019 2019 2027 2019 2019

DS DS

DP DP DP

DS

U-913 U-913 U-913 U-913 U-913

NCE

Oct

31, 2013

FEXOFENADINE HYDROCHLORIDE - ALLEGRA Nov 26, 2013 N020625 001 5578610 May 26, 2014 5578610*PED Feb 28, 2015 5738872 Aug 28, 2015 5738872*PED Feb 28, 2015 5855912 Aug 28, 2015 5855912*PED Feb 28, 2015 5932247 Aug 28, 2015 5932247*PED Mar 14, 2017 6037353 Sep 14, 2017 6037353*PED Feb 28, 2015 6113942 Aug 28, 2015 6113942*PED May 11, 2012 6187791 Nov 11, 2012 6187791*PED May 11, 2012 6399632 Nov 11, 2012 6399632*PED May 18, 2014 7135571 Nov 18, 2014 7135571*PED May 18, 2014 7138524 Nov 18, 2014 7138524*PED FEXOFENADINE HYDROCHLORIDE - ALLEGRA N021963 001 5578610 Nov 26, 2013 6037353 Mar 14, 2017 6187791 May 11, 2012 May 11, 2012 6399632 May 18, 2014 7138524 Nov 18, 2014 7138524*PED FEXOFENADINE HYDROCHLORIDE - ALLEGRA ALLERGY Nov 26, 2013 N020872 007 5578610 May 26, 2014 5578610*PED Feb 28, 2015 5855912 Aug 28, 2015 5855912*PED Feb 28, 2015 5932247 Aug 28, 2015 5932247*PED Mar 14, 2017 6037353 Sep 14, 2017 6037353*PED Feb 28, 2015 6113942 Aug 28, 2015 6113942*PED May 11, 2012 6187791 Nov 11, 2012 6187791*PED May 11, 2012 6399632 Nov 11, 2012 6399632*PED May 18, 2014 7135571 Nov 18, 2014 7135571*PED May 18, 2014 7138524 Nov 18, 2014 7138524*PED

U-192 U-192

U-138 U-138

U-138 U-138 U-468 U-468 DS DS

DS

DP

U-772 U-772 U-772 U-772

DS

DS

DP DP DP

U-1160

U-1160 DP U-1160 U-1160 DS DS U-1160

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 74 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DS DP DP DP U-1160 DP U-1160 U-1160 DS DS U-1160 U-1160

EXCLUSIVITY CODE(S)

FEXOFENADINE HYDROCHLORIDE - ALLEGRA ALLERGY N020872 010 5578610 Nov 26, 2013 5578610*PED May 26, 2014 Feb 28, 2015 5855912 Aug 28, 2015 5855912*PED Feb 28, 2015 5932247 Aug 28, 2015 5932247*PED Mar 14, 2017 6037353 Sep 14, 2017 6037353*PED Feb 28, 2015 6113942 Aug 28, 2015 6113942*PED May 11, 2012 6187791 Nov 11, 2012 6187791*PED May 11, 2012 6399632 Nov 11, 2012 6399632*PED May 18, 2014 7135571 Nov 18, 2014 7135571*PED May 18, 2014 7138524 Nov 18, 2014 7138524*PED FEXOFENADINE HYDROCHLORIDE - ALLEGRA HIVES N020872 008 5578610 Nov 26, 2013 5578610*PED May 26, 2014 Feb 28, 2015 5855912 Aug 28, 2015 5855912*PED Feb 28, 2015 5932247 Aug 28, 2015 5932247*PED Mar 14, 2017 6037353 Sep 14, 2017 6037353*PED Feb 28, 2015 6113942 Aug 28, 2015 6113942*PED May 11, 2012 6187791 Nov 11, 2012 6187791*PED May 11, 2012 6399632 Nov 11, 2012 6399632*PED May 18, 2014 7135571 Nov 18, 2014 7135571*PED May 18, 2014 7138524 Nov 18, 2014 7138524*PED FEXOFENADINE HYDROCHLORIDE - ALLEGRA HIVES N020872 009 5578610 Nov 26, 2013 5578610*PED May 26, 2014 Feb 28, 2015 5855912 Aug 28, 2015 5855912*PED Feb 28, 2015 5932247 Aug 28, 2015 5932247*PED Mar 14, 2017 6037353 Sep 14, 2017 6037353*PED Feb 28, 2015 6113942 Aug 28, 2015 6113942*PED May 11, 2012 6187791 Nov 11, 2012 6187791*PED May 11, 2012 6399632 Nov 11, 2012 6399632*PED May 18, 2014 7135571 Nov 18, 2014 7135571*PED May 18, 2014 7138524 Nov 18, 2014 7138524*PED

DS

DP DP DP

U-1160

U-1160 DP U-1160 U-1160 DS DS U-1160

DS

DP DP DP

U-1160

U-1160 DP U-1160 U-1160 DS DS U-1160

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 75 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
ALLERGY DS DP U-1160 DP DP U-1160 DP U-1160 U-1160 DS DS U-1160

EXCLUSIVITY CODE(S)

FEXOFENADINE HYDROCHLORIDE - CHILDREN'S ALLEGRA Nov 26, 2013 N020872 005 5578610 May 26, 2014 5578610*PED Feb 28, 2015 5855912 Aug 28, 2015 5855912*PED Feb 28, 2015 5932247 Aug 28, 2015 5932247*PED Mar 14, 2017 6037353 Sep 14, 2017 6037353*PED Feb 28, 2015 6113942 Aug 28, 2015 6113942*PED May 11, 2012 6187791 Nov 11, 2012 6187791*PED May 11, 2012 6399632 Nov 11, 2012 6399632*PED May 18, 2014 7135571 Nov 18, 2014 7135571*PED May 18, 2014 7138524 Nov 18, 2014 7138524*PED

FEXOFENADINE HYDROCHLORIDE - CHILDREN'S ALLEGRA ALLERGY Nov 26, 2013 DS DP U-1158 N021909 002 5578610 DP Feb 28, 2015 5738872 U-1158 Mar 14, 2017 6037353 U-1158 May 11, 2012 6187791 U-1158 May 11, 2012 6399632 DS May 18, 2014 7138524 FEXOFENADINE HYDROCHLORIDE - CHILDREN'S ALLEGRA ALLERGY N201373 001 5578610 Nov 26, 2013 DS DP U-1157 5578610*PED May 26, 2014 U-1157 Mar 14, 2017 6037353 Sep 14, 2017 6037353*PED May 11, 2012 U-1157 6187791 Nov 11, 2012 6187791*PED U-1157 May 11, 2012 6399632 Nov 11, 2012 6399632*PED DS May 18, 2014 7138524 Nov 18, 2014 7138524*PED FEXOFENADINE HYDROCHLORIDE - CHILDREN'S ALLEGRA N020872 006 5578610 Nov 26, 2013 5578610*PED May 26, 2014 Feb 28, 2015 5855912 Aug 28, 2015 5855912*PED Feb 28, 2015 5932247 Aug 28, 2015 5932247*PED Mar 14, 2017 6037353 Sep 14, 2017 6037353*PED Feb 28, 2015 6113942 Aug 28, 2015 6113942*PED May 11, 2012 6187791 Nov 11, 2012 6187791*PED May 11, 2012 6399632 Nov 11, 2012 6399632*PED May 18, 2014 7135571 Nov 18, 2014 7135571*PED May 18, 2014 7138524 Nov 18, 2014 7138524*PED HIVES DS DP DP DP U-1160 DP U-1160 U-1160 DS DS U-1160

U-1160

FEXOFENADINE HYDROCHLORIDE - CHILDREN'S ALLEGRA HIVES N021909 003 5578610 Nov 26, 2013 DS DP DP 5738872 Feb 28, 2015 6037353 Mar 14, 2017 6187791 May 11, 2012 May 11, 2012 6399632 May 18, 2014 DS 7138524

U-1158 U-1158 U-1158 U-1158

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 76 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-1157 U-1157 U-1157 U-1157

EXCLUSIVITY CODE(S)

FEXOFENADINE HYDROCHLORIDE - CHILDREN'S ALLEGRA HIVES N201373 002 5578610 Nov 26, 2013 DS DP 5578610*PED May 26, 2014 6037353 Mar 14, 2017 6037353*PED Sep 14, 2017 6187791 May 11, 2012 6187791*PED Nov 11, 2012 6399632 May 11, 2012 6399632*PED Nov 11, 2012 DS 7138524 May 18, 2014 7138524*PED Nov 18, 2014

FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE - ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION N020786 002 5578610 Nov 26, 2013 DS DP U-1159 5578610*PED May 26, 2014 5855912 Feb 28, 2015 DP 5855912*PED Aug 28, 2015 U-1159 6037353 Mar 14, 2017 U-138 6037353*PED Sep 14, 2017 6039974 Jul 31, 2018 DP DP 6113942 Feb 28, 2015 6113942*PED Aug 28, 2015 U-1159 6187791 May 11, 2012 U-138 6187791*PED Nov 11, 2012 6399632 May 11, 2012 U-1159 U-468 6399632*PED Nov 11, 2012 DS U-1159 7135571 May 18, 2014 7135571*PED Nov 18, 2014 DS 7138524 May 18, 2014 7138524*PED Nov 18, 2014 FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE - ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION N021704 002 5578610 Nov 26, 2013 DS DP U-1159 5578610*PED May 26, 2014 U-1159 6037353 Mar 14, 2017 6037353*PED Sep 14, 2017 U-1159 6187791 May 11, 2012 6187791*PED Nov 11, 2012 U-1159 6399632 May 11, 2012 6399632*PED Nov 11, 2012 DP U-1159 6613357 Dec 25, 2020 DS 7138524 May 18, 2014 7138524*PED Nov 18, 2014 DP RE39069 May 29, 2018 FIDAXOMICIN - DIFICID N201699 001 7378508 7863249 7906489 FINASTERIDE - PROPECIA N020788 001 5547957 5571817 5886184 FINASTERIDE - PROSCAR N020180 001 5886184 5942519 FINGOLIMOD - GILENYA N022527 001 5604229

Jul Jul Mar

31, 2027 31, 2027 04, 2027

DS DS

DP DP U-319

NCE

May

27, 2016

Oct Nov Nov

15, 2013 05, 2013 19, 2012

U-236 U-259

Nov Oct

19, 2012 23, 2018

DS U-280

Feb

18, 2014

DS

U-1086

M-106 NCE

Jul Sep

20, 2014 21, 2015

FLUDARABINE PHOSPHATE - OFORTA N022273 001 7148207 Dec 7547776 Dec FLUOCINOLONE ACETONIDE - RETISERT N021737 001 6217895 Mar 6548078 Mar

20, 2022 10, 2018

DP DS

U-944

NDF ODE

Dec Dec

18, 2011 18, 2015

22, 2019 22, 2019

DP DP

U-708 U-708

ODE

Apr

08, 2012

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 77 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)

FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN - TRI-LUMA DP N021112 001 7915243 Mar 22, 2026 DP 7939516 May 04, 2025 FLUOCINONIDE - VANOS N021758 001 6765001 7220424 7794738 FLUOROURACIL - CARAC N020985 001 6670335

Dec Jan Sep

21, 2021 07, 2023 11, 2022

DP U-861 U-1084

Jun

02, 2021

DP

U-68

FLUOXETINE HYDROCHLORIDE - PROZAC N018936 001 6960577 Nov FLUOXETINE HYDROCHLORIDE - PROZAC N018936 003 6960577 Nov FLUOXETINE HYDROCHLORIDE - PROZAC N018936 006 6960577 Nov

01, 2017

U-963

I-589

Mar

19, 2012

01, 2017

U-963

I-589

Mar

19, 2012

01, 2017

U-963

I-589

Mar

19, 2012

FLUOXETINE HYDROCHLORIDE - PROZAC WEEKLY N021235 001 5910319 May 29, 2017 5985322 May 29, 2017 RE39030 May 29, 2017 RE39030 May 29, 2017 FLUOXETINE HYDROCHLORIDE; OLANZAPINE - SYMBYAX N021520 001 5229382*PED Oct 23, 2011 6960577 Nov 01, 2017 FLUOXETINE HYDROCHLORIDE; OLANZAPINE - SYMBYAX N021520 002 5229382*PED Oct 23, 2011 5945416 Mar 24, 2017 6960577 Nov 01, 2017 FLUOXETINE HYDROCHLORIDE; OLANZAPINE - SYMBYAX N021520 003 5229382*PED Oct 23, 2011 5945416 Mar 24, 2017 6960577 Nov 01, 2017 FLUOXETINE HYDROCHLORIDE; OLANZAPINE - SYMBYAX N021520 004 5229382*PED Oct 23, 2011 5945416 Mar 24, 2017 6960577 Nov 01, 2017 FLUOXETINE HYDROCHLORIDE; OLANZAPINE - SYMBYAX N021520 005 5229382*PED Oct 23, 2011 5945416 Mar 24, 2017 6960577 Nov 01, 2017 FLUTICASONE FUROATE - VERAMYST N022051 001 6858596 Aug 7101866 Aug 7541350 Aug FLUTICASONE PROPIONATE - CUTIVATE N021152 001 7300669 Oct

DP DP

U-396 U-397 U-396 U-397

I-593 U-962

Mar

19, 2012

I-593 DS DP U-962 Y

Mar

19, 2012

I-593 DS DP U-962 Y

Mar

19, 2012

I-593 DS DP U-962 Y

Mar

19, 2012

I-593 DS DP U-962 Y

Mar

19, 2012

03, 2021 03, 2021 03, 2021

DS

DP DP DP

U-808 U-808 U-988

20, 2019 100 2011 2011 2016 2016 2011 2011 2011 2011 2011 2011

DP

U-835

FLUTICASONE PROPIONATE - FLOVENT DISKUS N020833 002 5590645*PED Sep 01, 5860419*PED Sep 01, 5873360 Feb 23, 5873360*PED Aug 23, Sep 01, 6032666*PED Sep 01, 6378519*PED Sep 01, 6536427*PED Sep 01, 6792945*PED Sep 01, 7225808*PED Sep 01, 7389775*PED

DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 78 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE
250 2011 2011 2016 2016 2011 2011 2011 2011 2011 2011 50 2011 2011 2016 2016 2011 2011 2011 2011 2011 2011

APPL/PROD NO

PATENT NO

PATENT CODES

PATENT DELIST REQUESTED

EXCLUSIVITY CODE(S)

EXCLUSIVITY EXPIRATION DATE

FLUTICASONE PROPIONATE - FLOVENT DISKUS N020833 003 5590645*PED Sep 01, 5860419*PED Sep 01, 5873360 Feb 23, 5873360*PED Aug 23, 6032666*PED Sep 01, 6378519*PED Sep 01, 6536427*PED Sep 01, 6792945*PED Sep 01, 7225808*PED Sep 01, 7389775*PED Sep 01, FLUTICASONE PROPIONATE - FLOVENT DISKUS N020833 001 5590645*PED Sep 01, 5860419*PED Sep 01, 5873360 Feb 23, 5873360*PED Aug 23, 6032666*PED Sep 01, 6378519*PED Sep 01, 6536427*PED Sep 01, 6792945*PED Sep 01, 7225808*PED Sep 01, 7389775*PED Sep 01, FLUTICASONE PROPIONATE - FLOVENT HFA N021433 001 5658549 Aug 19, 5658549*PED Feb 19, 5674472 Oct 07, 5674472*PED Apr 07, 6161724 Jan 16, 6161724*PED Jul 16, 6170717 Dec 23, 6170717*PED Jun 23, 6251368 Dec 04, 6251368*PED Jun 04, 6315173 Dec 23, 6315173*PED Jun 23, 6431168 Jun 08, 6431168*PED Dec 08, 6435372 Jan 16, 6435372*PED Jul 16, 6510969 Dec 23, 6510969*PED Jun 23, 6596260 Aug 10, 6596260*PED Feb 10, 6743413 Jun 01, 6743413*PED Dec 01, 6938796 Jan 16, 6938796*PED Jul 16, 6966467 Dec 23, 6966467*PED Jun 23, 6997349 Jan 16, 6997349*PED Jul 16, 7107986 Jun 08, 7107986*PED Dec 08, 7143908 Jan 16, 7143908*PED Jul 16, 7350676 Aug 24, 7350676*PED Feb 24, 7500444 Jan 04, 7500444*PED Jul 04,

DP

DP

2014 2015 2014 2015 2018 2018 2017 2018 2012 2013 2017 2018 2018 2018 2018 2018 2017 2018 2014 2015 2021 2021 2018 2018 2017 2018 2018 2018 2018 2019 2018 2018 2018 2019 2025 2025

DP DP DP DP DP DP DP DP DP DP

U-710

U-581 DP DP DP DP DP DP DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 79 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DP DP DP DP DP DP DP DP DP DP U-581 DP DP DP DP DP DP DP U-710

EXCLUSIVITY CODE(S)

FLUTICASONE PROPIONATE - FLOVENT HFA Aug 19, N021433 002 5658549 Feb 19, 5658549*PED Oct 07, 5674472 Apr 07, 5674472*PED Jan 16, 6161724 Jul 16, 6161724*PED Dec 23, 6170717 Jun 23, 6170717*PED Dec 04, 6251368 Jun 04, 6251368*PED Dec 23, 6315173 Jun 23, 6315173*PED Jun 08, 6431168 Dec 08, 6431168*PED Jan 16, 6435372 Jul 16, 6435372*PED Dec 23, 6510969 Jun 23, 6510969*PED Aug 10, 6596260 Feb 10, 6596260*PED Jun 01, 6743413 Dec 01, 6743413*PED Jan 16, 6938796 Jul 16, 6938796*PED Dec 23, 6966467 Jun 23, 6966467*PED Jan 16, 6997349 Jul 16, 6997349*PED Jun 08, 7107986 Dec 08, 7107986*PED Jan 16, 7143908 Jul 16, 7143908*PED Aug 24, 7350676 Feb 24, 7350676*PED Jan 04, 7500444 Jul 04, 7500444*PED

2014 2015 2014 2015 2018 2018 2017 2018 2012 2013 2017 2018 2018 2018 2018 2018 2017 2018 2014 2015 2021 2021 2018 2018 2017 2018 2018 2018 2018 2019 2018 2018 2018 2019 2025 2025

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 80 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DP DP DP DP DP DP DP DP DP DP DP DP U-581 U-581 DP DP DP DP DP DP DP U-710 U-710

EXCLUSIVITY CODE(S)

FLUTICASONE PROPIONATE - FLOVENT HFA N021433 003 5658549 Aug 19, Feb 19, 5658549*PED Oct 07, 5674472 Apr 07, 5674472*PED Jan 16, 6161724 Jul 16, 6161724*PED Dec 23, 6170717 Jun 23, 6170717*PED Dec 04, 6251368 Jun 04, 6251368*PED Dec 23, 6315173 Jun 23, 6315173*PED Jun 08, 6431168 Dec 08, 6431168*PED Jan 16, 6435372 Jul 16, 6435372*PED Dec 23, 6510969 Jun 23, 6510969*PED Aug 10, 6596260 Feb 10, 6596260*PED Jun 01, 6743413 Dec 01, 6743413*PED Jan 16, 6938796 Jul 16, 6938796*PED Dec 23, 6966467 Jun 23, 6966467*PED Jan 16, 6997349 Jul 16, 6997349*PED Jun 08, 7107986 Dec 08, 7107986*PED Jan 16, 7143908 Jul 16, 7143908*PED Aug 24, 7350676 Feb 24, 7350676*PED Jan 04, 7500444 Jul 04, 7500444*PED

2014 2015 2014 2015 2018 2018 2017 2018 2012 2013 2017 2018 2018 2018 2018 2018 2017 2018 2014 2015 2021 2021 2018 2018 2017 2018 2018 2018 2018 2019 2018 2018 2018 2019 2025 2025

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE - ADVAIR DISKUS 100/50 N021077 001 5590645*PED Sep 01, 2011 5860419*PED Sep 01, 2011 DP 5873360 Feb 23, 2016 5873360*PED Aug 23, 2016 6032666*PED Sep 01, 2011 6378519*PED Sep 01, 2011 6536427*PED Sep 01, 2011 6792945*PED Sep 01, 2011 7225808*PED Sep 01, 2011 7389775*PED Sep 01, 2011 FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE - ADVAIR DISKUS 250/50 N021077 002 5590645*PED Sep 01, 2011 5860419*PED Sep 01, 2011 DP 5873360 Feb 23, 2016 5873360*PED Aug 23, 2016 6032666*PED Sep 01, 2011 6378519*PED Sep 01, 2011 6536427*PED Sep 01, 2011 6792945*PED Sep 01, 2011 7225808*PED Sep 01, 2011 7389775*PED Sep 01, 2011

M-84

Mar

31, 2012

M-84

Mar

31, 2012

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 81 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)
M-84

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE - ADVAIR DISKUS 500/50 N021077 003 5590645*PED Sep 01, 2011 5860419*PED Sep 01, 2011 DP 5873360 Feb 23, 2016 5873360*PED Aug 23, 2016 6032666*PED Sep 01, 2011 6378519*PED Sep 01, 2011 6536427*PED Sep 01, 2011 6792945*PED Sep 01, 2011 7225808*PED Sep 01, 2011 7389775*PED Sep 01, 2011 FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE - ADVAIR HFA N021254 001 5658549 Aug 19, 2014 DP U-738 U-738 5658549*PED Feb 19, 2015 5674472 Oct 07, 2014 DP 5674472*PED Apr 07, 2015 DP 6161724 Jan 16, 2018 6161724*PED Jul 16, 2018 DP 6170717 Dec 23, 2017 6170717*PED Jun 23, 2018 DP 6251368 Dec 04, 2012 6251368*PED Jun 04, 2013 DP 6315173 Dec 23, 2017 6315173*PED Jun 23, 2018 DP 6431168 Jun 08, 2018 6431168*PED Dec 08, 2018 DP 6435372 Jan 16, 2018 6435372*PED Jul 16, 2018 6510969 Dec 23, 2017 6510969*PED Jun 23, 2018 DP 6596260 Aug 10, 2014 6596260*PED Feb 10, 2015 U-841 6743413 Jun 01, 2021 U-841 6743413*PED Dec 01, 2021 DP 6938796 Jan 16, 2018 6938796*PED Jul 16, 2018 DP 6966467 Dec 23, 2017 6966467*PED Jun 23, 2018 DP 6997349 Jan 16, 2018 6997349*PED Jul 16, 2018 DP 7107986 Jun 08, 2018 7107986*PED Dec 08, 2018 DP 7143908 Jan 16, 2018 7143908*PED Jul 16, 2018 DP 7350676 Aug 24, 2018 7350676*PED Feb 24, 2019 DP 7500444 Jan 04, 2025 7500444*PED Jul 04, 2025

Mar

31, 2012

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 82 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE - ADVAIR HFA Aug 19, 2014 DP U-738 N021254 002 5658549 Feb 19, 2015 DP U-738 5658549*PED DP Oct 07, 2014 5674472 DP Apr 07, 2015 5674472*PED Jan 16, 2018 DP 6161724 Jul 16, 2018 6161724*PED DP Dec 23, 2017 6170717 Jun 23, 2018 6170717*PED DP Dec 04, 2012 6251368 DP Jun 04, 2013 6251368*PED DP Dec 23, 2017 6315173 DP Jun 23, 2018 6315173*PED DP Jun 08, 2018 6431168 Dec 08, 2018 6431168*PED DP Jan 16, 2018 6435372 Jul 16, 2018 6435372*PED DP Dec 23, 2017 6510969 DP Jun 23, 2018 6510969*PED DP Aug 10, 2014 6596260 Feb 10, 2015 6596260*PED U-841 Jun 01, 2021 6743413 U-841 Dec 01, 2021 6743413*PED DP Jan 16, 2018 6938796 Jul 16, 2018 6938796*PED DP Dec 23, 2017 6966467 Jun 23, 2018 6966467*PED DP Jan 16, 2018 6997349 Jul 16, 2018 6997349*PED DP Jun 08, 2018 7107986 Dec 08, 2018 7107986*PED DP Jan 16, 2018 7143908 Jul 16, 2018 7143908*PED DP Aug 24, 2018 7350676 Feb 24, 2019 7350676*PED DP Jan 04, 2025 7500444 Jul 04, 2025 7500444*PED

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 83 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE - ADVAIR HFA Aug 19, 2014 DP U-738 N021254 003 5658549 Feb 19, 2015 DP U-738 5658549*PED DP Oct 07, 2014 5674472 DP Apr 07, 2015 5674472*PED Jan 16, 2018 DP 6161724 Jul 16, 2018 6161724*PED DP Dec 23, 2017 6170717 Jun 23, 2018 6170717*PED DP Dec 04, 2012 6251368 DP Jun 04, 2013 6251368*PED DP Dec 23, 2017 6315173 DP Jun 23, 2018 6315173*PED DP Jun 08, 2018 6431168 Dec 08, 2018 6431168*PED DP Jan 16, 2018 6435372 Jul 16, 2018 6435372*PED DP Dec 23, 2017 6510969 DP Jun 23, 2018 6510969*PED DP Aug 10, 2014 6596260 Feb 10, 2015 6596260*PED U-841 Jun 01, 2021 6743413 U-841 Dec 01, 2021 6743413*PED DP Jan 16, 2018 6938796 Jul 16, 2018 6938796*PED DP Dec 23, 2017 6966467 Jun 23, 2018 6966467*PED DP Jan 16, 2018 6997349 Jul 16, 2018 6997349*PED DP Jun 08, 2018 7107986 Dec 08, 2018 7107986*PED DP Jan 16, 2018 7143908 Jul 16, 2018 7143908*PED DP Aug 24, 2018 7350676 Feb 24, 2019 7350676*PED DP Jan 04, 2025 7500444 Jul 04, 2025 7500444*PED FLUVASTATIN SODIUM - LESCOL N020261 001 5354772 5354772 5354772*PED 5356896 5356896*PED FLUVASTATIN SODIUM - LESCOL N020261 002 5354772 5354772 5354772*PED 5356896 5356896*PED

Oct Oct Apr Dec Jun

11, 11, 11, 12, 12,

2011 2011 2012 2011 2012

U-109 U-413

Oct Oct Apr Dec Jun

11, 11, 11, 12, 12,

2011 2011 2012 2011 2012

U-109 U-413

FLUVASTATIN SODIUM - LESCOL XL N021192 001 5354772 Oct 5354772 Oct 5354772*PED Apr Dec 5356896 Jun 5356896*PED Apr 6242003 Oct 6242003*PED FLUVOXAMINE MALEATE - LUVOX CR N022033 001 7465462 May FLUVOXAMINE MALEATE - LUVOX CR May N022033 002 7465462 FOLLITROPIN ALFA/BETA - FOLLISTIM N020582 001 5767251 Jun

11, 11, 11, 12, 12, 13, 13,

2011 2011 2012 2011 2012 2020 2020

U-413 U-109

10, 2020

DP

U-929

10, 2020

DP

U-929

16, 2015

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 84 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)

FOLLITROPIN ALFA/BETA - FOLLISTIM N020582 002 5767251 Jun

16, 2015

FOLLITROPIN ALFA/BETA - FOLLISTIM AQ N021211 001 5767251 Jun 16, 5929028 Jan 14, 7446090 Aug 23, 7563763 Aug 23, 7563763 Aug 23, FOLLITROPIN ALFA/BETA - FOLLISTIM AQ N021211 002 5767251 Jun 16, 5929028 Jan 14, 7446090 Aug 23, 7563763 Aug 23, 7563763 Aug 23, FOLLITROPIN ALFA/BETA - FOLLISTIM AQ N021211 003 5767251 Jun 16, 5929028 Jan 14, 7446090 Aug 23, 7563763 Aug 23, 7563763 Aug 23, FOLLITROPIN ALFA/BETA - FOLLISTIM AQ N021211 004 5767251 Jun 16, 5929028 Jan 14, 7446090 Aug 23, 7563763 Aug 23, 7563763 Aug 23, FOLLITROPIN ALFA/BETA - FOLLISTIM AQ N021273 001 FOLLITROPIN ALFA/BETA - FOLLISTIM AQ N021273 002 FOLLITROPIN ALFA/BETA - GONAL-F N020378 001 5767251 Jun FOLLITROPIN ALFA/BETA - GONAL-F N020378 002 5767251 Jun FOLLITROPIN ALFA/BETA - GONAL-F N020378 003 5767251 Jun FOLLITROPIN ALFA/BETA - GONAL-F N020378 004 5767067 Jun 5767251 Jun 7563763 Aug FOLLITROPIN ALFA/BETA - GONAL-F N020378 005 5767067 Jun 5767251 Jun 7563763 Aug FOLLITROPIN ALFA/BETA - GONAL-F N021765 001 5767251 Jun FOLLITROPIN ALFA/BETA - GONAL-F N021765 003 5767251 Jun

2015 2018 2019 2019 2019

DS DP DP U-567 U-1183 U-993

D-133 I-306

Aug Jun

22, 2014 28, 2013

2015 2018 2019 2019 2019

DS DP DP U-567 U-1183 U-993

D-133 I-306

Aug Jun

22, 2014 28, 2013

2015 2018 2019 2019 2019

DS DP DP U-567 U-1183 U-993

D-133

Aug

22, 2014

2015 2018 2019 2019 2019

DS DP DP U-567 U-993 U-1183

D-133 I-306

Aug Jun

22, 2014 28, 2013

I-306

Jun

28, 2013

I-306 16, 2015 DS

Jun

28, 2013

16, 2015

DS

16, 2015

DS

16, 2015 16, 2015 23, 2019

DS DS DP

16, 2015 16, 2015 23, 2019

DS DS DP

16, 2015

DS

16, 2015

DS

FOLLITROPIN ALFA/BETA - GONAL-F RFF N021765 002 5767067 Jun 16, 2015 5767251 Jun 16, 2015 FOLLITROPIN ALFA/BETA - GONAL-F RFF N021684 001 5767067 Jun 5767251 Jun 7446090 Aug 7741268 Apr PEN 16, 16, 23, 02,

DS DS

2015 2015 2019 2024

DS DS DP DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 85 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE
PEN 16, 16, 23, 02, PEN 16, 16, 23, 02,

APPL/PROD NO

PATENT NO

PATENT CODES
DS DS DP DP

PATENT DELIST REQUESTED

EXCLUSIVITY CODE(S)

EXCLUSIVITY EXPIRATION DATE

FOLLITROPIN ALFA/BETA - GONAL-F RFF N021684 002 5767067 Jun 5767251 Jun 7446090 Aug 7741268 Apr FOLLITROPIN ALFA/BETA - GONAL-F RFF N021684 003 5767067 Jun 5767251 Jun 7446090 Aug 7741268 Apr FOMEPIZOLE - ANTIZOL N020696 001 7553863

2015 2015 2019 2024

2015 2015 2019 2024

DS DS DP DP

Jun

30, 2027

DS

DP

FOMIVIRSEN SODIUM - VITRAVENE PRESERVATIVE FREE N020961 001 5442049 Aug 15, 2012 5595978 Aug 15, 2012 FORMOTEROL FUMARATE - FORADIL N020831 001 6488027 6887459

U-522

Mar Nov

08, 2019 28, 2020

U-762

FORMOTEROL FUMARATE - PERFOROMIST N022007 001 6667344 Jun 6814953 Jun 7348362 Jun 7462645 Jun

22, 22, 22, 22,

2021 2021 2021 2021 - DULERA 2014 2014 2014 2014 2017 2014 2020 2020 - DULERA 2014 2014 2014 2014 2017 2014 2020 2020

DP DP DP DP

U-813 U-813

FORMOTEROL FUMARATE; MOMETASONE FUROATE N022518 001 5889015 Jan 27, 5889015*PED Jul 27, 6057307 Jan 27, 6057307*PED Jul 27, 6068832 Aug 27, Jan 27, 6677323 May 21, 7067502 May 08, 7566705 FORMOTEROL FUMARATE; MOMETASONE FUROATE N022518 002 5889015 Jan 27, 5889015*PED Jul 27, 6057307 Jan 27, 6057307*PED Jul 27, 6068832 Aug 27, Jan 27, 6677323 May 21, 7067502 May 08, 7566705 FOSAMPRENAVIR CALCIUM - LEXIVA N021548 001 6436989 6436989*PED 6514953 6514953*PED

U-1068 DP DP DP DP U-1068 U-1068 U-1068 U-1068 U-1068

NC

Jun

22, 2013

U-1068 DP DP DP DP U-1068 U-1068 U-1068 U-1068 U-1068

NC

Jun

22, 2013

Dec Jun Jul Jan

24, 24, 15, 15,

2017 2018 2019 2020

DS DS

DP DP

U-257 U-257

FOSAMPRENAVIR CALCIUM - LEXIVA N022116 001 6436989 Dec 6436989*PED Jun FOSAPREPITANT DIMEGLUMINE - EMEND N022023 001 5512570 Mar 5538982 Jul 5691336 Mar 5716942 Feb 7214692 Sep FOSAPREPITANT DIMEGLUMINE - EMEND N022023 002 5691336 Mar

24, 2017 24, 2018

DS

DP

U-257

04, 23, 04, 10, 18,

2014 2013 2019 2015 2012

U-850 U-850 DS DP U-850 U-850

NCE

Jan

25, 2013

04, 2019

DS

DP

D-128 NCE

Nov Jan

12, 2013 25, 2013

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 86 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DS DS DP U-945

EXCLUSIVITY CODE(S)
NCE

FOSPROPOFOL DISODIUM - LUSEDRA N022244 001 6204257 Aug Aug 6872838 FROVATRIPTAN SUCCINATE - FROVA N021006 001 5464864 Nov 5616603 Apr 5637611 Jun 5827871 Oct 5962501 Dec FULVESTRANT - FASLODEX N021344 001 6774122 6774122*PED 7456160 7456160*PED GABAPENTIN - GABAPENTIN A078974 001 GABAPENTIN - GRALISE N022544 001 6340475 6488962 6635280 6723340 7438927 7731989 GABAPENTIN - GRALISE N022544 002 6340475 6488962 6635280 6723340 7438927 7731989 GABAPENTIN - NEURONTIN N020235 001 6054482 6054482*PED GABAPENTIN - NEURONTIN N020235 002 6054482 6054482*PED GABAPENTIN - NEURONTIN N020235 003 6054482 6054482*PED GABAPENTIN - NEURONTIN N020882 001 6054482 6054482*PED GABAPENTIN - NEURONTIN N020882 002 6054482 6054482*PED GABAPENTIN - NEURONTIN N021129 001 6054482 6054482*PED 7256216 7256216*PED

07, 2018 07, 2018

Dec

12, 2013

07, 01, 10, 27, 16,

2015 2014 2014 2015 2013

U-436 U-436 U-436 U-436 U-436

Jan Jul Jan Jul

09, 09, 09, 09,

2021 2021 2021 2021

U-596 U-596

D-126 M-103 PED PED

Sep May Nov Mar

09, 17, 17, 09,

2013 2014 2014 2014

PC Sep Jun Sep Oct Feb Oct 19, 20, 19, 25, 26, 25, 2016 2020 2016 2021 2024 2022 DP DP DP DP U-1114 DP

Aug

22, 2011

NP

Jan

28, 2014

Sep Jun Sep Oct Feb Oct

19, 20, 19, 25, 26, 25,

2016 2020 2016 2021 2024 2022

DP DP DP DP U-1114 DP

NP

Jan

28, 2014

Apr Oct

25, 2017 25, 2017

Apr Oct

25, 2017 25, 2017

Apr Oct

25, 2017 25, 2017

Apr Oct

25, 2017 25, 2017

Apr Oct

25, 2017 25, 2017

Apr Oct May Nov

25, 25, 28, 28,

2017 2017 2022 2022

DP

GABAPENTIN ENACARBIL - HORIZANT N022399 001 6818787 Nov 8026279 Nov 8048917 Nov

06, 2022 10, 2026 06, 2022

DS DS DS

DP DP DP

NCE

Apr

06, 2016

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 87 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DS DS DS DP DP DP

EXCLUSIVITY CODE(S)
NCE

GABAPENTIN ENACARBIL - HORIZANT N022399 002 6818787 Nov 8026279 Nov 8048917 Nov

06, 2022 10, 2026 06, 2022

Apr

06, 2016

GADOBENATE DIMEGLUMINE - MULTIHANCE N021357 001 4916246 Apr 10, 2012 GADOBENATE DIMEGLUMINE - MULTIHANCE Apr 10, 2012 N021357 002 4916246 GADOBENATE DIMEGLUMINE - MULTIHANCE N021357 003 4916246 Apr 10, 2012 GADOBENATE DIMEGLUMINE - MULTIHANCE Apr 10, 2012 N021357 004 4916246 GADOBENATE DIMEGLUMINE - MULTIHANCE MULTIPACK Apr 10, 2012 N021358 001 4916246 GADOBENATE DIMEGLUMINE - MULTIHANCE MULTIPACK N021358 002 4916246 Apr 10, 2012 GADOBUTROL - GADAVIST N201277 001 5980864 GADOBUTROL - GADAVIST N201277 002 5980864 GADOBUTROL - GADAVIST N201277 003 5980864 GADOBUTROL - GADAVIST N201277 004 5980864 GADOBUTROL - GADAVIST N201277 005 5980864 GADODIAMIDE - OMNISCAN N020123 001 5362475 5560903 GADODIAMIDE - OMNISCAN N022066 001 5560903 GADODIAMIDE - OMNISCAN N022066 002 5362475 5560903

DS

NPP

Mar

17, 2013

DS

NPP

Mar

17, 2013

DS

NPP

Mar

17, 2013

DS

NPP

Mar

17, 2013

DS

DS

Nov

09, 2016

DS

DP

U-1119

NCE

Mar

14, 2016

Nov

09, 2016

DS

DP

U-1119

NCE

Mar

14, 2016

Nov

09, 2016

DS

DP

U-1119

NCE

Mar

14, 2016

Nov

09, 2016

DS

DP

U-1119

NCE

Mar

14, 2016

Nov

09, 2016

DS

DP

U-1119

NCE

Mar

14, 2016

Nov Oct

08, 2011 01, 2013

DS DP

Oct

01, 2013

DP

Nov Oct

08, 2011 01, 2013

DS DP

GADOFOSVESET TRISODIUM - ABLAVAR N021711 001 5362475 Nov 6676929 May Feb 7011815 May 7060250 May 7229606 May 8017105 GADOFOSVESET TRISODIUM - ABLAVAR Nov N021711 002 5362475 May 6676929 Feb 7011815 May 7060250 May 7229606 May 8017105

08, 26, 01, 26, 26, 26,

2011 2015 2015 2015 2015 2015

DS DP U-1112 DS U-1112 DS

NCE

Dec

22, 2013

08, 26, 01, 26, 26, 26,

2011 2015 2015 2015 2015 2015

DS DP U-1112 DS U-1112 DS

NCE

Dec

22, 2013

GADOPENTETATE DIMEGLUMINE - MAGNEVIST N019596 001 5362475 Nov 08, 2011 GADOPENTETATE DIMEGLUMINE - MAGNEVIST N021037 001 5362475 Nov 08, 2011

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 88 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-480 U-480

EXCLUSIVITY CODE(S)

GADOTERIDOL - PROHANCE N020131 001 5474756 5846519 6143274

Dec Dec Dec

12, 2012 08, 2015 12, 2012

GADOTERIDOL - PROHANCE MULTIPACK N021489 001 5474756 Dec 5846519 Dec 6143274 Dec GADOXETATE DISODIUM - EOVIST N022090 001

12, 2012 08, 2015 12, 2012

U-536 U-536

NCE

Jul

03, 2013

GALANTAMINE HYDROBROMIDE - RAZADYNE N021169 001 6099863 Jun 06, 2017 6358527 Jun 06, 2017 GALANTAMINE HYDROBROMIDE - RAZADYNE N021169 002 6099863 Jun 06, 2017 6358527 Jun 06, 2017 GALANTAMINE HYDROBROMIDE - RAZADYNE N021169 003 6099863 Jun 06, 2017 6358527 Jun 06, 2017 GALANTAMINE HYDROBROMIDE - RAZADYNE ER N021615 001 7160559 Dec 20, 2019 GALANTAMINE HYDROBROMIDE - RAZADYNE ER N021615 002 7160559 Dec 20, 2019 GALANTAMINE HYDROBROMIDE - RAZADYNE ER N021615 003 7160559 Dec 20, 2019 GANCICLOVIR - VITRASERT N020569 001 5378475 GANCICLOVIR - ZIRGAN N022211 001 GANIRELIX ACETATE - GANIRELIX ACETATE INJECTION DS N021057 001 4801577 Feb 05, 2012 5767082 Jun 16, 2015 GATIFLOXACIN - ZYMAR N021493 001 5880283 5880283*PED 6333045 6333045*PED GATIFLOXACIN - ZYMAXID N022548 001 5880283 5880283*PED 6333045 6333045*PED GEFITINIB - IRESSA N021399 001 5457105 5616582 5770599

DP

U-322

DP

U-322

DP

U-322

DP

DP

DP

Jan

03, 2012

NDF ODE DP

Sep Sep

15, 2012 15, 2016

Dec Jun Aug Feb

05, 05, 20, 20,

2015 2016 2019 2020

DP

Dec Jun Aug Feb

05, 05, 20, 20,

2015 2016 2019 2020

DS DS DP

NP

May

18, 2013

Jan Jan May

19, 2013 19, 2013 05, 2017

DS

DP

U-881

GEMCITABINE HYDROCHLORIDE - GEMCITABINE HYDROCHLORIDE A077983 001 GEMCITABINE HYDROCHLORIDE - GEMCITABINE HYDROCHLORIDE A077983 002 GEMCITABINE HYDROCHLORIDE - GEMZAR Nov N020509 001 5464826 May 5464826*PED

PC

Jul

24, 2011

PC U-146

Jul

24, 2011

07, 2012 07, 2013

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 89 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-146

EXCLUSIVITY CODE(S)

GEMCITABINE HYDROCHLORIDE - GEMZAR N020509 002 5464826 Nov 5464826*PED May GEMIFLOXACIN MESYLATE - FACTIVE N021158 001 5633262 Jun 5776944 Apr Jun 5962468 Sep 6262071 Sep 6331550 Sep 6340689 Sep 6455540 Mar 6723734 Sep 6803376 Sep 6803376 GEMTUZUMAB OZOGAMICIN - MYLOTARG Dec N021174 001 5585089 Feb 5606040 Dec 5693762 Apr 5739116 Jun 5767285 Jun 5773001 GLATIRAMER ACETATE - COPAXONE N020622 001 5981589 6054430 6342476 6362161 6620847 6939539 7199098 GLATIRAMER ACETATE - COPAXONE N020622 002 5981589 6054430 6342476 6362161 6620847 6939539 7199098

07, 2012 07, 2013

15, 04, 15, 21, 21, 14, 21, 20, 21, 21,

2015 2017 2015 2019 2019 2019 2019 2018 2019 2019

DS

DP U-282 U-513 U-511 U-512 U-511

DS DS DS

DP DP DP

U-608 U-609

17, 25, 02, 14, 16, 30,

2013 2014 2014 2015 2015 2015

U-320

May May May May May May May

24, 24, 24, 24, 24, 24, 24,

2014 2014 2014 2014 2014 2014 2014

I-594 U-441 U-441 DS DS DS

Feb

27, 2012

May May May May May May May

24, 24, 24, 24, 24, 24, 24,

2014 2014 2014 2014 2014 2014 2014

I-594 U-441 U-441 DS DS DS

Feb

27, 2012

GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE - DUETACT N021925 001 6150383 Jun 19, 2016 6211205 Jun 19, 2016 6303640 Aug 09, 2016 Jun 19, 2016 6329404 Jun 19, 2016 7538125 Jan 30, 2027 7700128 Jun 08, 2028 8071130 GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE - DUETACT N021925 002 6150383 Jun 19, 2016 6211205 Jun 19, 2016 6303640 Aug 09, 2016 Jun 19, 2016 6329404 Jun 19, 2016 7538125 Jan 30, 2027 7700128 Jun 08, 2028 8071130 GLIMEPIRIDE; ROSIGLITAZONE MALEATE - AVANDARYL N021700 001 5002953 Sep 17, 2011 Sep 17, 2011 5002953 Mar 17, 2012 5002953*PED Apr 21, 2015 5741803 Apr 21, 2015 5741803 Oct 21, 2015 5741803*PED Apr 19, 2020 7358366 Oct 19, 2020 7358366*PED

DP DP DP DP

U-753 U-753 U-753 U-753

DP DP DP DP

U-753 U-753 U-753 U-753

DS DS DS DS DS

DP DP DP DP

U-690 U-781 U-781 U-781 U-690

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 90 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DS DS DS DS DS DP DP DP DP U-690 U-781 U-690 U-781

EXCLUSIVITY CODE(S)

GLIMEPIRIDE; ROSIGLITAZONE MALEATE - AVANDARYL N021700 002 5002953 Sep 17, 2011 Sep 17, 2011 5002953 Mar 17, 2012 5002953*PED Apr 21, 2015 5741803 Apr 21, 2015 5741803 Oct 21, 2015 5741803*PED Apr 19, 2020 7358366 Oct 19, 2020 7358366*PED GLIMEPIRIDE; ROSIGLITAZONE MALEATE - AVANDARYL N021700 003 5002953 Sep 17, 2011 Sep 17, 2011 5002953 Mar 17, 2012 5002953*PED Apr 21, 2015 5741803 Apr 21, 2015 5741803 Oct 21, 2015 5741803*PED Apr 19, 2020 7358366 Oct 19, 2020 7358366*PED GLIMEPIRIDE; ROSIGLITAZONE MALEATE - AVANDARYL N021700 004 5002953 Sep 17, 2011 Mar 17, 2012 5002953*PED Apr 19, 2020 7358366 Oct 19, 2020 7358366*PED GLIMEPIRIDE; ROSIGLITAZONE MALEATE - AVANDARYL N021700 005 5002953 Sep 17, 2011 5002953*PED Mar 17, 2012 7358366 Apr 19, 2020 7358366*PED Oct 19, 2020 GLIPIZIDE - GLUCOTROL XL N020329 001 5591454 GLIPIZIDE - GLUCOTROL XL N020329 002 5591454 GLIPIZIDE - GLUCOTROL XL N020329 003 5591454 GLUTAMINE - NUTRESTORE N021667 001 5288703

DS DS DS DS DS

DP DP DP DP

U-690 U-781 U-690 U-781

DS DS

DP

U-840

DS DS

DP

U-840

Jan

07, 2014

U-150

Jan

07, 2014

U-150

Jan

07, 2014

U-111

Oct

07, 2011

U-898

GLYBURIDE; METFORMIN HYDROCHLORIDE - GLUCOVANCE N021178 001 6303146 Jul 14, 2019 6303146*PED Jan 14, 2020 GLYBURIDE; METFORMIN HYDROCHLORIDE - GLUCOVANCE N021178 002 6303146 Jul 14, 2019 6303146*PED Jan 14, 2020 GLYBURIDE; METFORMIN HYDROCHLORIDE - GLUCOVANCE N021178 003 6303146 Jul 14, 2019 6303146*PED Jan 14, 2020 GLYCOPYRROLATE - CUVPOSA N022571 001 7638552 7816396 GLYCOPYRROLATE - ROBINUL N012827 001 7091236

U-412 U-412

U-412 U-412

U-412 U-412

Aug Aug

20, 2023 20, 2023

U-1076 U-1076

NP

Jul

28, 2013

Apr

24, 2024

U-877

GLYCOPYRROLATE - ROBINUL FORTE N012827 002 7091236 Apr GOSERELIN ACETATE - ZOLADEX N019726 001 7118552 7220247 7500964

24, 2024

U-877

Apr Apr Feb

13, 2022 09, 2022 26, 2021

DP DP DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 91 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DP DP DP

EXCLUSIVITY CODE(S)

GOSERELIN ACETATE - ZOLADEX N020578 001 7118552 7220247 7500964 GRANISETRON - SANCUSO N022198 001 7608282

Apr Apr Feb

13, 2022 09, 2022 26, 2021

Oct

22, 2024

DP

U-1011

NE NDF

Sep Sep

12, 2011 12, 2011

GRANISETRON HYDROCHLORIDE - KYTRIL N020239 001 5952340 Sep 6294548 May GRANISETRON HYDROCHLORIDE - KYTRIL N020239 002 5952340 Sep 6294548 May GRANISETRON HYDROCHLORIDE - KYTRIL N020239 003 GRANISETRON HYDROCHLORIDE - KYTRIL N020239 004 5952340 Sep 6294548 May

14, 2016 04, 2019

U-519

M-102

Apr

29, 2014

14, 2016 04, 2019

U-519

M-102

Apr

29, 2014

M-102 14, 2016 04, 2019 U-519

Apr

29, 2014

M-102

Apr

29, 2014

GREPAFLOXACIN HYDROCHLORIDE - RAXAR N020695 001 5563138 Oct 08, 2013 GUAIFENESIN - MUCINEX N021282 001 6372252 6955821 7838032 GUAIFENESIN - MUCINEX N021282 002 6372252 6955821 7838032

Apr Apr Apr

28, 2020 28, 2020 28, 2020

DP DP

U-489 U-489

Apr Apr Apr

28, 2020 28, 2020 28, 2020

DP DP

U-489 U-489

GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE - MUCINEX D N021585 001 6372252 Apr 28, 2020 DP DP U-686 6955821 Apr 28, 2020 DP 7838032 Apr 28, 2020 GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE - MUCINEX D N021585 002 6372252 Apr 28, 2020 DP DP U-686 6955821 Apr 28, 2020 DP 7838032 Apr 28, 2020 GUANFACINE HYDROCHLORIDE - INTUNIV N022037 001 5854290 Sep 6287599 Dec 6811794 Jul GUANFACINE HYDROCHLORIDE - INTUNIV N022037 002 5854290 Sep 6287599 Dec 6811794 Jul GUANFACINE HYDROCHLORIDE - INTUNIV N022037 003 5854290 Sep 6287599 Dec 6811794 Jul GUANFACINE HYDROCHLORIDE - INTUNIV N022037 004 5854290 Sep 6287599 Dec 6811794 Jul

21, 2015 20, 2020 04, 2022

U-494 DP DP U-494

I-635 NP

Feb Sep

25, 2014 02, 2012

21, 2015 20, 2020 04, 2022

U-494 DP DP U-494

I-635 NP

Feb Sep

25, 2014 02, 2012

21, 2015 20, 2020 04, 2022

U-494 DP DP U-494

I-635 NP

Feb Sep

25, 2014 02, 2012

21, 2015 20, 2020 04, 2022

U-494 DP DP U-494

I-635 NP

Feb Sep

25, 2014 02, 2012

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 92 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-1087 U-1087 U-1087 U-1087

EXCLUSIVITY CODE(S)
NP

HEXAMINOLEVULINATE HYDROCHLORIDE - CYSVIEW KIT N022555 001 6034267 Mar 08, 2016 7247655 Mar 08, 2016 7348361 Apr 22, 2019 7530461 Jan 11, 2017 HISTRELIN ACETATE - SUPPRELIN LA N022058 001 8062652 Jun

May

28, 2013

DP DP DP

16, 2026

U-1197

ODE

May

03, 2014

HYALURONIDASE RECOMBINANT HUMAN - HYLENEX RECOMBINANT N021859 001 7767429 Sep 23, 2027 DS DP HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE - BIDIL U-71 N020727 001 6465463 Sep 08, 2020 U-71 6784177 Sep 08, 2020 HYDROCHLOROTHIAZIDE; IRBESARTAN - AVALIDE N020758 001 5270317 Sep 30, 2011 5270317*PED Mar 30, 2012 5994348 Jun 07, 2015 5994348*PED Dec 07, 2015 HYDROCHLOROTHIAZIDE; IRBESARTAN - AVALIDE N020758 002 5270317 Sep 30, 2011 5270317*PED Mar 30, 2012 5994348 Jun 07, 2015 5994348*PED Dec 07, 2015 HYDROCHLOROTHIAZIDE; IRBESARTAN - AVALIDE N020758 003 5270317 Sep 30, 2011 5270317*PED Mar 30, 2012 5994348 Jun 07, 2015 5994348*PED Dec 07, 2015 HYDROCHLOROTHIAZIDE; IRBESARTAN - AVALIDE N020758 004 5270317 Sep 30, 2011 5270317*PED Mar 30, 2012 5994348 Jun 07, 2015 5994348*PED Dec 07, 2015

DS

DP DP

HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL - BENICAR HCT DS DP U-500 N021532 002 5616599 Apr 25, 2016 5616599*PED Oct 25, 2016 U-3 6878703 Nov 19, 2021 6878703*PED May 19, 2022 HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL - BENICAR HCT DS DP U-500 N021532 003 5616599 Apr 25, 2016 5616599*PED Oct 25, 2016 U-3 6878703 Nov 19, 2021 6878703*PED May 19, 2022 HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL - BENICAR HCT DS DP U-500 N021532 005 5616599 Apr 25, 2016 5616599*PED Oct 25, 2016 U-3 6878703 Nov 19, 2021 6878703*PED May 19, 2022 HYDROCHLOROTHIAZIDE; TELMISARTAN - MICARDIS HCT DS N021162 001 5591762 Jan 07, 2014 6358986 Jan 10, 2020 HYDROCHLOROTHIAZIDE; TELMISARTAN - MICARDIS HCT DS N021162 002 5591762 Jan 07, 2014 6358986 Jan 10, 2020 HYDROCHLOROTHIAZIDE; TELMISARTAN - MICARDIS HCT DS N021162 003 5591762 Jan 07, 2014

DP

U-3

DP

U-3

DP

U-3

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 93 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE
- DIOVAN Mar 21, Sep 21, Jun 18, Dec 18, - DIOVAN Mar 21, Sep 21, Jun 18, Dec 18, - DIOVAN Mar 21, Sep 21, Jun 18, Dec 18, - DIOVAN Mar 21, Sep 21, Jun 18, Dec 18, - DIOVAN Mar 21, Sep 21, Jun 18, Dec 18, HCT 2012 2012 2017 2017 HCT 2012 2012 2017 2017 HCT 2012 2012 2017 2017 HCT 2012 2012 2017 2017 HCT 2012 2012 2017 2017

APPL/PROD NO

PATENT NO

PATENT CODES
U-3 U-3

PATENT DELIST REQUESTED

EXCLUSIVITY CODE(S)
I-567

EXCLUSIVITY EXPIRATION DATE

HYDROCHLOROTHIAZIDE; VALSARTAN N020818 001 5399578 5399578*PED 6294197 6294197*PED HYDROCHLOROTHIAZIDE; VALSARTAN N020818 002 5399578 5399578*PED 6294197 6294197*PED HYDROCHLOROTHIAZIDE; VALSARTAN N020818 003 5399578 5399578*PED 6294197 6294197*PED HYDROCHLOROTHIAZIDE; VALSARTAN N020818 004 5399578 5399578*PED 6294197 6294197*PED HYDROCHLOROTHIAZIDE; VALSARTAN N020818 005 5399578 5399578*PED 6294197 6294197*PED

Jul

31, 2011

U-3 U-3

I-567

Jul

31, 2011

U-3 U-3

I-567

Jul

31, 2011

U-3 U-3

I-567

Jul

31, 2011

U-3 U-3

I-567

Jul

31, 2011

HYDROCODONE BITARTRATE; IBUPROFEN - VICOPROFEN N020716 001 6348216 Jun 10, 2017 6599531 Jun 10, 2017 HYDROCORTISONE BUTYRATE - LOCOID N022076 001 7378405 Dec 7981877 Jan

19, 2026 23, 2025

DP DP

HYDROCORTISONE BUTYRATE - LOCOID LIPOCREAM N020769 001 5635497 Jun 03, 2014 HYDROMORPHONE HYDROCHLORIDE - DILAUDID N019034 003 6589960 Nov 09, 2020 HYDROMORPHONE HYDROCHLORIDE - DILAUDID N019034 004 6589960 Nov 09, 2020 HYDROMORPHONE HYDROCHLORIDE - DILAUDID N019034 005 6589960 Nov 09, 2020 HYDROMORPHONE HYDROCHLORIDE - DILAUDID N019891 001 6589960 Nov 09, 2020 HYDROMORPHONE HYDROCHLORIDE - DILAUDID N019892 001 6589960 Nov 09, 2020 HYDROMORPHONE HYDROCHLORIDE - DILAUDID N019892 002 6589960 Nov 09, 2020 HYDROMORPHONE HYDROCHLORIDE - DILAUDID N019892 003 6589960 Nov 09, 2020 HYDROMORPHONE HYDROCHLORIDE - DILAUDID-HP N019034 001 6589960 Nov 09, 2020 HYDROMORPHONE HYDROCHLORIDE - DILAUDID-HP N019034 002 6589960 Nov 09, 2020 HYDROMORPHONE HYDROCHLORIDE - EXALGO N021217 001 5702725 Jul 07, 2014 5914131 Jul 07, 2014

I-613

Oct

19, 2012

DS

DP

DS

DP

DS

DP

DS

DP

DS

DP

DS

DP

DS

DP

DP

DP

DP DP

U-1043 U-1043

NDF

Mar

01, 2013

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 94 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DP DP U-1043 U-1043

EXCLUSIVITY CODE(S)
NDF

HYDROMORPHONE HYDROCHLORIDE - EXALGO N021217 002 5702725 Jul 07, 2014 5914131 Jul 07, 2014 HYDROMORPHONE HYDROCHLORIDE - EXALGO N021217 003 5702725 Jul 07, 2014 5914131 Jul 07, 2014 HYDROMORPHONE HYDROCHLORIDE - PALLADONE N021044 001 5958452 Nov 04, 2014 5965161 Nov 04, 2014 5968551 Dec 24, 2011 6294195 Dec 24, 2011 6335033 Nov 04, 2014 6589960 Nov 09, 2020 6706281 Nov 04, 2014 6743442 Nov 04, 2014 HYDROMORPHONE HYDROCHLORIDE - PALLADONE N021044 002 5958452 Nov 04, 2014 5965161 Nov 04, 2014 5968551 Dec 24, 2011 6294195 Dec 24, 2011 6335033 Nov 04, 2014 6589960 Nov 09, 2020 6706281 Nov 04, 2014 6743442 Nov 04, 2014 HYDROMORPHONE HYDROCHLORIDE - PALLADONE N021044 003 5958452 Nov 04, 2014 5965161 Nov 04, 2014 5968551 Dec 24, 2011 6294195 Dec 24, 2011 6335033 Nov 04, 2014 6589960 Nov 09, 2020 6706281 Nov 04, 2014 6743442 Nov 04, 2014 HYDROMORPHONE HYDROCHLORIDE - PALLADONE N021044 004 5958452 Nov 04, 2014 5965161 Nov 04, 2014 5968551 Dec 24, 2011 6294195 Dec 24, 2011 6335033 Nov 04, 2014 6589960 Nov 09, 2020 6706281 Nov 04, 2014 6743442 Nov 04, 2014 HYDROXOCOBALAMIN - CYANOKIT N022041 001 5834448 HYDROXOCOBALAMIN - CYANOKIT N022041 002 5834448

Mar

01, 2013

DP DP

U-1043 U-1043

NDF

Mar

01, 2013

DP DP DP DP DP DP DP DP

U-616

U-616 U-616

DP DP DP DP DP DP DP DP

U-616

U-616 U-616

DP DP DP DP DP DP DP DP

U-616

U-616 U-616

DP DP DP DP DP DP DP DP

U-616

U-616 U-616

Nov

14, 2016

DP

ODE

Dec

15, 2013

Nov

14, 2016

DP

U-789

ODE

Dec

15, 2013

HYDROXYPROGESTERONE CAPROATE - MAKENA N021945 001 IBANDRONATE SODIUM - BONIVA N021455 001 4927814 4927814 6143326 6294196 IBANDRONATE SODIUM - BONIVA N021455 002 4927814 4927814 6294196 7192938 7410957 7718634

ODE 2012 2012 2017 2019 DS DS DP DP DP U-700 U-642 U-642

Feb

03, 2018

Mar Mar Apr Oct

17, 17, 21, 07,

Mar Mar Oct May May May

17, 17, 07, 06, 06, 06,

2012 2012 2019 2023 2023 2023

DS DS

DP DP DP

U-700 U-642 U-798 U-887 U-642

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 95 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DS DP DP U-700

EXCLUSIVITY CODE(S)

IBANDRONATE SODIUM - BONIVA N021858 001 4927814 5662918 IBUPROFEN - CALDOLOR N022348 001 6727286 IBUPROFEN - CALDOLOR N022348 002 6727286 IBUPROFEN - CHILDREN'S MOTRIN N020516 001 5374659 5374659*PED IBUPROFEN - CHILDREN'S MOTRIN N020603 001 5374659 5374659*PED IBUPROFEN - MIDOL LIQUID GELS N021472 001 6251426 IBUPROFEN - MOTRIN N019842 001 5374659 5374659*PED IBUPROFEN - MOTRIN N020135 001 5320855*PED IBUPROFEN - MOTRIN N020135 002 5320855*PED IBUPROFEN LYSINE - NEOPROFEN N021903 001 6342530 6342530 6344479

Mar Sep

17, 2012 02, 2014

Nov

27, 2021

DP

U-981

NP

Jun

11, 2012

Nov

27, 2021

DP

U-981

NP

Jun

11, 2012

Dec Jun

20, 2011 20, 2012

Dec Jun

20, 2011 20, 2012

Jun

25, 2018

Dec Jun

20, 2011 20, 2012

Dec

14, 2011

Dec

14, 2011

Nov Nov Mar

14, 2020 14, 2020 20, 2021

DS

DP DP DP

U-794 U-1127 U-794

ODE Y

Apr

13, 2013

IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE - CHILDREN'S MOTRIN COLD N021128 001 6211246 Jun 10, 2019 ICATIBANT ACETATE - FIRAZYR N022150 001 5648333 ICODEXTRIN - EXTRANEAL N021321 001 6077836 6248726 ILOPERIDONE - FANAPT N022192 001 RE39198 ILOPERIDONE - FANAPT N022192 002 RE39198 ILOPERIDONE - FANAPT N022192 003 RE39198 ILOPERIDONE - FANAPT N022192 004 RE39198 ILOPERIDONE - FANAPT N022192 005 RE39198 ILOPERIDONE - FANAPT N022192 006 RE39198 ILOPERIDONE - FANAPT N022192 007 RE39198 ILOPROST - VENTAVIS N021779 001

Jul

15, 2014

DS

DP

U-1187

NCE ODE

Aug Aug

25, 2016 25, 2018

Jun Jun

20, 2017 19, 2018

U-495 U-495

Nov

15, 2016

DS

DP

U-971

NCE

May

06, 2014

Nov

15, 2016

DS

DP

U-971

NCE

May

06, 2014

Nov

15, 2016

DS

DP

U-971

NCE

May

06, 2014

Nov

15, 2016

DS

DP

U-971

NCE

May

06, 2014

Nov

15, 2016

DS

DP

U-971

NCE

May

06, 2014

Nov

15, 2016

DS

DP

U-971

NCE

May

06, 2014

Nov

15, 2016

DS

DP

U-971

NCE

May

06, 2014

ODE

Dec

29, 2011

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 96 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)
ODE

ILOPROST - VENTAVIS N021779 002 ILOPROST - VENTAVIS N021779 003 IMATINIB MESYLATE - GLEEVEC N021335 001 5521184 5521184*PED 6894051 6894051*PED 6958335 6958335*PED IMATINIB MESYLATE - GLEEVEC N021335 002 5521184 5521184*PED 6894051 6894051*PED 6958335 6958335*PED IMATINIB MESYLATE - GLEEVEC N021588 001 5521184 5521184*PED 6894051 6894051*PED 6958335 6958335*PED 7544799 7544799*PED IMATINIB MESYLATE - GLEEVEC N021588 002 5521184 5521184*PED 6894051 6894051*PED 6958335 6958335*PED 7544799 7544799*PED IMIGLUCERASE - CEREZYME N020367 001 5549892 IMIGLUCERASE - CEREZYME N020367 002 5549892 IMIQUIMOD - ALDARA N020723 001 7696159 7696159 7696159*PED IMIQUIMOD - ZYCLARA N022483 001 IMIQUIMOD - ZYCLARA N022483 002 INDACATEROL MALEATE - ARCAPTA NEOHALER N022383 001 6878721 Oct 10, 2020 INDINAVIR SULFATE - CRIXIVAN N020685 001 5413999 6645961 6689761

Dec

29, 2011

ODE Jan Jul May Nov Dec Jun 04, 04, 23, 23, 19, 19, 2015 2015 2019 2019 2021 2022 DS DS DP DP U-649 U-791

Dec

29, 2011

Jan Jul May Nov Dec Jun

04, 04, 23, 23, 19, 19,

2015 2015 2019 2019 2021 2022

DS DS

DP DP

U-649 U-649 U-791

Jan Jul May Nov Dec Jun Jan Jul

04, 04, 23, 23, 19, 19, 16, 16,

2015 2015 2019 2019 2021 2022 2019 2019

DS DS

DP DP U-649 U-791

DS

DP

I-583 ODE ODE ODE ODE ODE

Dec Oct Oct Oct Oct Oct

19, 19, 19, 19, 19, 19,

2011 2013 2013 2013 2013 2013

Jan Jul May Nov Dec Jun Jan Jul

04, 04, 23, 23, 19, 19, 16, 16,

2015 2015 2019 2019 2021 2022 2019 2019

DS

DP

U-649 U-791

DS

DP

I-583 ODE ODE ODE ODE ODE

Dec Oct Oct Oct Oct Oct

19, 19, 19, 19, 19, 19,

2011 2013 2013 2013 2013 2013

Aug

27, 2013

U-252

Aug

27, 2013

U-252

Apr Apr Oct

01, 2024 01, 2024 01, 2024

DS DS

U-1048 U-1047

I-636 NP

Mar Mar

24, 2014 25, 2013

NS DS DP U-1168

Jul

15, 2014

NCE

Jul

01, 2016

May Mar Feb

09, 2012 04, 2018 10, 2021

U-132 DP U-554

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 97 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-132 DP U-554

EXCLUSIVITY CODE(S)

INDINAVIR SULFATE - CRIXIVAN N020685 003 5413999 6645961 6689761 INDINAVIR SULFATE - CRIXIVAN N020685 005 5413999 6645961 6689761 INDINAVIR SULFATE - CRIXIVAN N020685 006 5413999 6645961 6689761

May Mar Feb

09, 2012 04, 2018 10, 2021

May Mar Feb

09, 2012 04, 2018 10, 2021

U-132 DP U-554

May Mar Feb

09, 2012 04, 2018 10, 2021

U-132 DP U-554

INDIUM IN-111 PENTETREOTIDE KIT - OCTREOSCAN N020314 001 5384113 Jan 24, 2012 5753627 May 19, 2015 5776894 Jul 07, 2015

DP U-1125 DS DP

INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT - NOVOLOG MIX 50/50 DS DP N021810 001 5547930 Sep 28, 2013 DS DP 5618913 Jun 07, 2014 5618913*PED Dec 07, 2014 DP U-471 5834422 Sep 28, 2013 DS DP U-471 5840680 Sep 28, 2013 DP 5866538 Jun 20, 2017 5866538*PED Dec 20, 2017 INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT - NOVOLOG MIX 70/30 DS DP N021172 001 5547930 Sep 28, 2013 DS DP 5618913 Jun 07, 2014 5618913*PED Dec 07, 2014 DP U-471 5834422 Sep 28, 2013 DS DP U-471 5840680 Sep 28, 2013 DP 5866538 Jun 19, 2017 INSULIN ASPART RECOMBINANT - NOVOLOG N020986 001 5618913 Jun 07, 2014 5618913*PED Dec 07, 2014 5866538 Jun 20, 2017 5866538*PED Dec 20, 2017 INSULIN DETEMIR RECOMBINANT - LEVEMIR N021536 001 5750497 May 16, 5866538 Jun 20, 6011007 Feb 02, 6869930 Feb 02, INSULIN GLARGINE RECOMBINANT - LANTUS N021081 001 5656722 Aug 12, 5656722*PED Feb 12, 7476652 Jul 23, 7476652*PED Jan 23, 7713930 Jun 13, 7713930*PED Dec 13, 7918833 Sep 23, 7918833*PED Mar 23, INSULIN GLULISINE RECOMBINANT - APIDRA N021629 001 6221633 Jun 18, 6960561 Jan 25, 7452860 Mar 22, 7696162 Mar 22, INSULIN GLULISINE RECOMBINANT - APIDRA N021629 002 6221633 Jun 18, 6960561 Jan 25, 7452860 Mar 22, 7696162 Mar 22,

DS

DP

2019 2017 2014 2014

DS DS DS

DP DP DP DP

U-668 U-668 U-668

2014 2015 2023 2024 2023 2023 2027 2028

DS

DP DP DP DP

U-948

2018 2023 2022 2022

DS

DP DP DP DP

U-471 U-471 U-471

NPP

Oct

24, 2011

2018 2023 2022 2022

DS

DP DP DP DP

U-471 U-471 U-471

NPP

Oct

24, 2011

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 98 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DP DP DP DP DP U-471 U-471 U-471

EXCLUSIVITY CODE(S)
NPP

INSULIN GLULISINE RECOMBINANT - APIDRA SOLOSTAR N021629 003 6221633 Jun 18, 2018 DS 6960561 Jan 25, 2023 7452860 Mar 22, 2022 7696162 Mar 22, 2022 7918833 Sep 23, 2027

Oct

24, 2011

INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT - HUMALOG MIX 50/50 N021018 001 5461031 Jun 26, 2014 5474978 Jun 16, 2014 5514646 May 07, 2013 5747642 Jun 16, 2014 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT - HUMALOG MIX 75/25 N021017 001 5461031 Jun 16, 2014 5474978 Jun 16, 2014 5514646 May 07, 2013 5747642 Jun 16, 2014 INSULIN LISPRO RECOMBINANT - HUMALOG N020563 001 5474978 Jun 16, 2014 5514646 May 07, 2013 INSULIN LISPRO RECOMBINANT - HUMALOG PEN N020563 002 5474978 Jun 16, 2014 5514646 May 07, 2013 INSULIN RECOMBINANT HUMAN - EXUBERA N021868 001 5740794 Apr 21, 2015 5997848 Mar 07, 2014 6051256 Mar 07, 2014 6257233 May 14, 2019 6423344 Mar 07, 2014 6543448 Sep 21, 2014 6546929 May 14, 2019 6582728 Jun 24, 2020 6592904 Mar 07, 2014 6685967 Sep 11, 2018 6737045 Mar 07, 2014 INSULIN RECOMBINANT HUMAN - EXUBERA N021868 002 5740794 Apr 21, 2015 5997848 Mar 07, 2014 6051256 Mar 07, 2014 6257233 May 14, 2019 6423344 Mar 07, 2014 6543448 Sep 21, 2014 6546929 May 14, 2019 6582728 Jun 24, 2020 6592904 Mar 07, 2014 6685967 Sep 11, 2018 6737045 Mar 07, 2014 INSULIN RECOMBINANT HUMAN - HUMULIN R N018780 001 INSULIN RECOMBINANT HUMAN - HUMULIN R PEN N018780 005 IOBENGUANE SULFATE I-123 - ADREVIEW N022290 001 IODIXANOL - VISIPAQUE 270 N020351 001 5349085 5366722 RE36418

U-534 U-534

U-534 U-534

DP U-704 DP U-704 DP DP U-704 DP DP DP U-704

DP U-704 DP U-704 DP DP U-704 DP DP DP U-704

NR

Mar

25, 2014

NR

Mar

25, 2014

NCE ODE 20, 2011 22, 2011 12, 2011

Sep Sep

19, 2013 19, 2015

Sep Nov Jul

DP DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 99 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)

IODIXANOL - VISIPAQUE 270 N020808 001 5349085 5366722 RE36418 IODIXANOL - VISIPAQUE 320 N020351 002 5349085 RE36418 IODIXANOL - VISIPAQUE 320 N020808 002 5349085 RE36418 IOFLUPANE I-123 - DATSCAN N022454 001

Sep Nov Jul

20, 2011 22, 2011 12, 2011

DP DP

Sep Jul

20, 2011 12, 2011

DP

Sep Jul

20, 2011 12, 2011

DP

NCE

Jan

14, 2016

IOPROMIDE - ULTRAVIST (PHARMACY BULK) N021425 002 IOPROMIDE - ULTRAVIST 370 N020220 001 IPRATROPIUM BROMIDE - ATROVENT N021527 001 5676930 5683677 6739333 6983743 IRBESARTAN - AVAPRO N020757 001 5270317 5270317*PED 6342247 6342247*PED IRBESARTAN - AVAPRO N020757 002 5270317 5270317*PED 6342247 6342247*PED IRBESARTAN - AVAPRO N020757 003 5270317 5270317*PED 6342247 6342247*PED HFA Oct Nov May May

I-619

Dec

30, 2012

I-619 14, 04, 26, 26, 2014 2014 2020 2020 DP DP DP DP

Dec

30, 2012

Sep Mar Jun Dec

30, 30, 07, 07,

2011 2012 2015 2015

Sep Mar Jun Dec

30, 30, 07, 07,

2011 2012 2015 2015

Sep Mar Jun Dec

30, 30, 07, 07,

2011 2012 2015 2015

IRINOTECAN HYDROCHLORIDE - CAMPTOSAR Apr 28, 2020 N020571 001 6403569 Oct 28, 2020 6403569*PED May 01, 2020 6794370 Nov 01, 2020 6794370*PED IRINOTECAN HYDROCHLORIDE - CAMPTOSAR N020571 002 6403569 Apr 28, 2020 6403569*PED Oct 28, 2020 6794370 May 01, 2020 Nov 01, 2020 6794370*PED IRON DEXTRAN - DEXFERRUM A040024 001 5624668 ITRACONAZOLE - ONMEL N022484 001 6509038 7081255 ITRACONAZOLE - SPORANOX N020083 001 5633015 ITRACONAZOLE - SPORANOX N020657 001 5707975 6407079

U-449 U-606

U-449 U-606

Sep

29, 2015

May May

12, 2017 12, 2017

DP DP

U-1054 U-1054

NP

Apr

29, 2013

May

27, 2014

Jan Jun

13, 2015 18, 2019

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 100 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)

ITRACONAZOLE - SPORANOX N020966 001 6407079 IXABEPILONE - IXEMPRA KIT N022065 001 6670384 6670384 6670384*PED 7022330 7022330*PED 7125899 7125899*PED 7312237 7312237*PED RE41393 RE41393*PED RE41911 RE41911*PED IXABEPILONE - IXEMPRA KIT N022065 002 6670384 6670384 6670384*PED 7022330 7022330*PED 7125899 7125899*PED 7312237 7312237*PED RE41393 RE41393*PED RE41911 RE41911*PED KETOCONAZOLE - EXTINA N021738 001 7553835 KETOCONAZOLE - KETOCONAZOLE A091550 001 KETOCONAZOLE - NIZORAL A-D N020310 001 5456851 KETOCONAZOLE - XOLEGEL N021946 001 7179475

Jun

18, 2019

Jan Jan Jul Jan Jul May Nov Aug Feb Feb Aug May Nov

23, 23, 23, 23, 23, 26, 26, 21, 21, 08, 08, 26, 26,

2022 2022 2022 2022 2022 2018 2018 2024 2025 2022 2022 2018 2018

DP DP DP DS DP

U-959 U-960 U-958 U-957 U-965 U-961

M-61 NCE PED PED

Oct Oct Apr Apr

18, 16, 18, 16,

2014 2012 2015 2013

DS

DP

U-961

Jan Jan Jul Jan Jul May Nov Aug Feb Feb Aug May Nov

23, 23, 23, 23, 23, 26, 26, 21, 21, 08, 08, 26, 26,

2022 2022 2022 2022 2022 2018 2018 2024 2025 2022 2022 2018 2018

DP DP DP DS DP

U-960 U-959 U-958 U-957 U-965 U-961

M-61 NCE PED PED

Oct Oct Apr Apr

18, 16, 18, 16,

2014 2012 2015 2013

DS

DP

U-961

Oct

19, 2018

DP

U-245

PC Apr 07, 2014

Feb

21, 2012

Dec

04, 2018

DP

U-792

KETOROLAC TROMETHAMINE - ACULAR LS May N021528 001 8008338 KETOROLAC TROMETHAMINE - ACUVAIL Aug N022427 001 7842714 KETOROLAC TROMETHAMINE - SPRIX N022382 001 6333044 Dec 7476689 Oct LACOSAMIDE - VIMPAT N022253 001 5654301 RE38551 LACOSAMIDE - VIMPAT N022253 002 5654301 RE38551 LACOSAMIDE - VIMPAT N022253 003 5654301 RE38551 LACOSAMIDE - VIMPAT N022253 004 5654301 RE38551

24, 2027

U-1181

15, 2029

DS

DP

NP

Jul

22, 2012

25, 2018 11, 2012

DP DP

U-1057 U-1056

NDF

May

14, 2013

Aug Mar

05, 2014 17, 2017

DS DS

DP DP

U-914 U-914

NCE

Oct

28, 2013

Aug Mar

05, 2014 17, 2017

DS DS

DP DP

U-914 U-914

NCE

Oct

28, 2013

Aug Mar

05, 2014 17, 2017

DS DS

DP DP

U-914 U-914

NCE

Oct

28, 2013

Aug Mar

05, 2014 17, 2017

DS DS

DP DP

U-914 U-914

NCE

Oct

28, 2013

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 101 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DS DS DP DP U-911 U-911

EXCLUSIVITY CODE(S)
NCE

LACOSAMIDE - VIMPAT N022254 001 5654301 RE38551 LACOSAMIDE - VIMPAT N022255 001 5654301 RE38551 LAMIVUDINE - EPIVIR N020564 001 5905082 5905082*PED LAMIVUDINE - EPIVIR N020564 003 5905082 5905082*PED LAMIVUDINE - EPIVIR N020596 001 6004968 6004968*PED LAMIVUDINE - EPIVIR-HBV N021003 001 5905082 5905082*PED RE39155 RE39155*PED LAMIVUDINE - EPIVIR-HBV N021004 001 6004968 6004968*PED RE39155 RE39155*PED

Aug Mar

05, 2014 17, 2017

Oct

28, 2013

Aug Mar

05, 2014 17, 2017

DS DS

DP DP

U-914 U-914

NCE

Oct

28, 2013

May Nov

18, 2016 18, 2016

DS

DP

U-248

May Nov

18, 2016 18, 2016

Mar Sep

20, 2018 20, 2018

May Nov Jul Jan

18, 18, 02, 02,

2016 2016 2013 2014

U-250

Mar Sep Jul Jan

20, 20, 02, 02,

2018 2018 2013 2014

U-250

LAMIVUDINE; ZIDOVUDINE - COMBIVIR N020857 001 5859021 May May 5905082 Nov 5905082*PED LAMOTRIGINE - LAMICTAL CD N020764 001 5698226 5698226*PED LAMOTRIGINE - LAMICTAL CD N020764 002 5698226 5698226*PED LAMOTRIGINE - LAMICTAL CD N020764 003 5698226 5698226*PED LAMOTRIGINE - LAMICTAL CD N020764 004 5698226 5698226*PED LAMOTRIGINE - LAMICTAL ODT N022251 001 7919115 LAMOTRIGINE - LAMICTAL ODT N022251 002 7919115 LAMOTRIGINE - LAMICTAL ODT N022251 003 7919115 LAMOTRIGINE - LAMICTAL ODT N022251 004 7919115 LAMOTRIGINE - LAMICTAL XR N022115 001

15, 2012 18, 2016 18, 2016

DS DS

DP DP

U-248 U-248 U-248

Jan Jul

29, 2012 29, 2012

Jan Jul

29, 2012 29, 2012

Jan Jul

29, 2012 29, 2012

Jan Jul

29, 2012 29, 2012

Jan

04, 2029

DS

DP

Jan

04, 2029

DS

DP

Jan

04, 2029

DS

DP

Jan

04, 2029

DS

DP

I-644 I-622 NDF PED

Apr Jan May Nov

25, 29, 29, 29,

2014 2013 2012 2012

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 102 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)
I-644 I-622 NDF PED

LAMOTRIGINE - LAMICTAL XR N022115 002

Apr Jan May Nov

15, 29, 29, 29,

2014 2013 2012 2012

LAMOTRIGINE - LAMICTAL XR N022115 003

I-644 I-622 NDF PED

Apr Jan May Nov

25, 29, 29, 29,

2014 2013 2012 2012

LAMOTRIGINE - LAMICTAL XR N022115 004

I-644 I-622 NDF PED

Apr Jan May Nov

25, 29, 29, 29,

2014 2013 2012 2012

LAMOTRIGINE - LAMICTAL XR N022115 005

I-644 I-622 NDF PED

Apr Jan May Nov

25, 29, 29, 29,

2014 2013 2012 2012

LAMOTRIGINE - LAMICTAL XR N022115 006

I-622 I-644 NDF PED DP U-831

Jan Apr May Nov

29, 25, 29, 29,

2013 2014 2012 2012

LANREOTIDE ACETATE - SOMATULINE DEPOT N022074 001 5595760 Mar 08, 2020

D-131 NCE ODE

Mar Aug Aug

04, 2014 30, 2012 30, 2014

LANREOTIDE ACETATE - SOMATULINE DEPOT N022074 002 5595760 Mar 08, 2020

DP

U-831

D-131 NCE ODE

Mar Aug Aug

04, 2014 30, 2012 30, 2014

LANREOTIDE ACETATE - SOMATULINE DEPOT N022074 003 5595760 Mar 08, 2020

DP

U-831

D-131 NCE ODE

Mar Aug Aug

04, 2014 30, 2012 30, 2014

LANSOPRAZOLE - PREVACID N020406 001 LANSOPRAZOLE - PREVACID N020406 002 LANSOPRAZOLE - PREVACID N021281 001 LANSOPRAZOLE - PREVACID N021281 002

M-85 PED

Oct Apr

28, 2011 28, 2012

M-85 PED

Oct Apr

28, 2011 28, 2012

M-85 PED

Oct Apr

28, 2011 28, 2012

M-85 PED

Oct Apr

28, 2011 28, 2012

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 103 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)
M-85 PED

LANSOPRAZOLE - PREVACID N021428 001 5464632 5464632*PED 6328994 6328994*PED 7399485 7399485*PED 7431942 7431942*PED 7875292 7875292*PED LANSOPRAZOLE - PREVACID N021428 002 5464632 5464632*PED 6328994 6328994*PED 7399485 7399485*PED 7431942 7431942*PED 7875292 7875292*PED LANSOPRAZOLE - PREVACID 24 HR N022327 001 LANSOPRAZOLE - PREVACID IV N021566 001 7396841 7396841*PED

Nov May May Nov May Nov May Nov May Nov

07, 07, 17, 17, 26, 26, 17, 17, 17, 17,

2012 2013 2019 2019 2018 2018 2019 2019 2019 2019

Oct Apr

28, 2011 28, 2012

DP DP DP

Nov May May Nov May Nov May Nov May Nov

07, 07, 17, 17, 26, 26, 17, 17, 17, 17,

2012 2013 2019 2019 2018 2018 2019 2019 2019 2019

M-85 PED DP DP DP

Oct Apr

28, 2011 28, 2012

NP Aug Feb 17, 2021 17, 2022 DP U-947

May

18, 2012

LANTHANUM CARBONATE - FOSRENOL N021468 001 5968976 Oct 7381428 Aug Aug 7465465 LANTHANUM CARBONATE - FOSRENOL N021468 002 5968976 Oct 7381428 Aug Aug 7465465 LANTHANUM CARBONATE - FOSRENOL N021468 003 5968976 Oct 7381428 Aug Aug 7465465 LANTHANUM CARBONATE - FOSRENOL Oct N021468 004 5968976 Aug 7381428 Aug 7465465 LAPATINIB DITOSYLATE - TYKERB N022059 001 6391874 6713485 6727256 6828320 7157466

26, 2018 26, 2024 26, 2024

DP DP

U-613 U-890

26, 2018 26, 2024 26, 2024

DP DP

U-613 U-890

26, 2018 26, 2024 26, 2024

DP DP

U-613 U-890

26, 2018 26, 2024 26, 2024

DP DP

U-613 U-890

Jul Sep Jan Jul Nov

11, 29, 08, 11, 19,

2017 2020 2019 2017 2021

DS DS DS DS

DP DP DP DP

U-800 U-800 U-800 U-800

I-620 NCE

Jan Mar

29, 2013 13, 2012

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 104 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DS U-866 U-694 U-769 U-694 DP U-694 U-694 U-694 U-694 DP U-1079 DS DS DP DP U-1165

EXCLUSIVITY CODE(S)
ODE ODE

LENALIDOMIDE - REVLIMID N021880 001 5635517 6045501 6281230 6315720 6555554 6561976 6561977 6755784 6908432 7119106 7189740 7465800 7855217 7968569 LENALIDOMIDE - REVLIMID N021880 002 5635517 6045501 6281230 6315720 6555554 6561976 6561977 6755784 6908432 7119106 7189740 7465800 7855217 7968569 LENALIDOMIDE - REVLIMID N021880 003 5635517 6045501 6281230 6315720 6555554 6561976 6561977 6755784 6908432 7119106 7189740 7465800 7968569 LENALIDOMIDE - REVLIMID N021880 004 5635517 6045501 6281230 6315720 6555554 6561976 6561977 6755784 6908432 7119106 7189740 7465800 7855217 7968569 LENALIDOMIDE - REVLIMID N021880 005

Oct Aug Jul Oct Jul Aug Oct Oct Aug Jul Apr Apr Nov Oct

04, 28, 24, 23, 24, 28, 23, 23, 28, 24, 11, 22, 24, 07,

2019 2018 2016 2020 2016 2018 2020 2020 2018 2016 2023 2026 2024 2023

Jun Dec

29, 2013 27, 2012

Oct Aug Jul Oct Jul Aug Oct Oct Aug Jul Apr Apr Nov Oct

04, 28, 24, 23, 24, 28, 23, 23, 28, 24, 11, 22, 24, 07,

2019 2018 2016 2020 2016 2018 2020 2020 2018 2016 2023 2026 2024 2023

DS

U-866 U-694 U-769 U-694 DP U-694 U-694 U-694 U-694 DP U-1079

ODE ODE

Jun Dec

29, 2013 27, 2012

DS DS

DP DP U-1165

Oct Aug Jul Oct Jul Aug Oct Oct Aug Jul Apr Apr Oct

04, 28, 24, 23, 24, 28, 23, 23, 28, 24, 11, 22, 07,

2019 2018 2016 2020 2016 2018 2020 2020 2018 2016 2023 2026 2023

DS

U-866 U-694 U-769 U-694 DP U-694 U-694 U-694 U-694 DP U-1079

ODE

Jun

29, 2013

DS

DP U-1165

Oct Aug Jul Oct Jul Aug Oct Oct Aug Jul Apr Apr Nov Oct

04, 28, 24, 23, 24, 28, 23, 23, 28, 24, 11, 22, 24, 07,

2019 2018 2016 2020 2016 2018 2020 2020 2018 2016 2023 2026 2024 2023

DS

U-866 U-694 U-769 U-694 DP U-694 U-694 U-694 U-694 DP U-1079

ODE

Jun

29, 2013

DS DS

DP DP U-1165

ODE ODE

Dec Jun

27, 2012 29, 2013

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 105 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)

LEUPROLIDE ACETATE - ELIGARD N021343 001 5324519 5599552 6395293 6565874 6626870 6773714 LEUPROLIDE ACETATE - ELIGARD N021379 001 5324519 5599552 6395293 6565874 6626870 6773714 LEUPROLIDE ACETATE - ELIGARD N021488 001 5324519 5599552 6395293 6565874 6626870 6773714 LEUPROLIDE ACETATE - ELIGARD N021731 001 5599552 6395293 6565874 6626870 6773714

Oct Feb Sep Oct Mar Oct

20, 04, 28, 28, 27, 28,

2011 2014 2013 2018 2020 2018

DP DP DP DP

U-801 U-801 U-801

Oct Feb Sep Oct Mar Oct

20, 04, 28, 28, 27, 28,

2011 2014 2013 2018 2020 2018

DP DP DP DP

U-801 U-801

Oct Feb Sep Oct Mar Oct

20, 04, 28, 28, 27, 28,

2011 2014 2013 2018 2020 2018

DP DP DP DP

U-801 U-801

Feb Sep Oct Mar Oct

04, 28, 28, 27, 28,

2014 2013 2018 2020 2018

DP DP DP DP

U-621 U-621 U-621

LEUPROLIDE ACETATE - LUPRON DEPOT N019732 001 5575987 Sep 5631020 May Sep 5716640 Dec 6036976 LEUPROLIDE ACETATE - LUPRON DEPOT Sep N020011 001 5575987 May 5631021 Sep 5716640 LEUPROLIDE ACETATE - LUPRON DEPOT Jan N020517 001 5480656 Sep 5575987 May 5631020 Jan 5643607 Sep 5716640 Dec 6036976 LEUPROLIDE ACETATE - LUPRON DEPOT Jan N020517 002 5480656 Sep 5575987 May 5631020 Jan 5643607 Sep 5716640 Dec 6036976 LEUPROLIDE ACETATE - LUPRON DEPOT N020517 003 6036976 Dec 7429559 Dec LEUPROLIDE ACETATE - LUPRON DEPOT N020708 001 5480656 Jan 5575987 Sep May 5631020 Jan 5643607 Sep 5716640 Dec 6036976

02, 20, 02, 13,

2013 2014 2013 2016

02, 2013 20, 2014 02, 2013

02, 02, 20, 02, 02, 13,

2013 2013 2014 2013 2013 2016

02, 02, 20, 02, 02, 13,

2013 2013 2014 2013 2013 2016

13, 2016 13, 2016

DP DP

D-132 NS

Jun Jun

17, 2014 17, 2014

02, 02, 20, 02, 02, 13,

2013 2013 2014 2013 2013 2016

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 106 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)
M-107

LEUPROLIDE ACETATE - LUPRON DEPOT-PED Sep 02, N020263 002 5575987 May 20, 5631020 Sep 02, 5716640 Dec 13, 6036976 LEUPROLIDE ACETATE - LUPRON DEPOT-PED Sep 02, N020263 003 5575987 May 20, 5631020 Sep 02, 5716640 Dec 13, 6036976 LEUPROLIDE ACETATE - LUPRON DEPOT-PED Sep 02, N020263 004 5575987 May 20, 5631020 Sep 02, 5716640 Dec 13, 6036976 LEUPROLIDE ACETATE - LUPRON DEPOT-PED Sep 02, N020263 005 5575987 May 20, 5631020 Sep 02, 5716640 Dec 13, 6036976 LEUPROLIDE ACETATE - LUPRON DEPOT-PED Sep 02, N020263 006 5575987 May 20, 5631020 Sep 02, 5716640 Dec 13, 6036976 LEUPROLIDE ACETATE - LUPRON DEPOT-PED Sep 02, N020263 007 5575987 May 20, 5631020 Sep 02, 5716640 Dec 13, 6036976 LEUPROLIDE ACETATE - LUPRON DEPOT-PED N020263 008 5480656 Jan 02, 5575987 Sep 02, May 20, 5631020 Jan 02, 5643607 Sep 02, 5716640 Dec 13, 6036976 LEUPROLIDE ACETATE - VIADUR N021088 001 5728396 5932547 5985305 6113938 6124261 6132420 6156331 6235712 6375978 6395292

2013 2014 2013 2016

Oct

08, 2014

2013 2014 2013 2013

2013 2014 2013 2013

2013 2014 2013 2016

M-107

Oct

08, 2014

2013 2014 2013 2016

M-107

Oct

08, 2014

2013 2014 2013 2016

DP DP DP DP

NP

Aug

15, 2014

2013 2013 2014 2013 2013 2016

DP DP DP DP DP DP

NP

Aug

15, 2014

Jan Jun Jan Jul Jun Jan Jan Jun Dec Jan

30, 13, 30, 24, 13, 30, 30, 13, 17, 30,

2017 2017 2017 2018 2017 2017 2017 2017 2018 2017

U-316

LEVALBUTEROL HYDROCHLORIDE - XOPENEX Mar 25, 2013 N020837 001 5362755 Aug 20, 2013 5547994 Mar 21, 2021 6451289 LEVALBUTEROL HYDROCHLORIDE - XOPENEX Mar 25, 2013 N020837 002 5362755 Aug 20, 2013 5547994 Mar 21, 2021 6451289 LEVALBUTEROL HYDROCHLORIDE - XOPENEX N020837 003 5362755 Mar 25, 2013 5547994 Aug 20, 2013 Mar 21, 2021 6451289

U-332 U-332

U-332 U-332

U-332 U-332

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 107 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-332 U-332 DP

EXCLUSIVITY CODE(S)

LEVALBUTEROL HYDROCHLORIDE - XOPENEX N020837 004 5362755 Mar 25, 2013 5547994 Aug 20, 2013 Mar 21, 2021 6451289 LEVALBUTEROL TARTRATE - XOPENEX HFA N021730 001 5362755 Mar 5547994 Aug Feb 5605674 Nov 5836299 Oct 7256310 LEVETIRACETAM - KEPPRA XR N022285 001 7858122 LEVETIRACETAM - KEPPRA XR N022285 002 7858122 LEVETIRACETAM - LEVETIRACETAM A091093 001 LEVETIRACETAM - LEVETIRACETAM A091093 002 LEVETIRACETAM - LEVETIRACETAM A091261 002 LEVETIRACETAM - LEVETIRACETAM A091285 001 LEVETIRACETAM - LEVETIRACETAM A091285 002 LEVETIRACETAM - LEVETIRACETAM A091291 002 LEVETIRACETAM - LEVETIRACETAM A091399 001 LEVETIRACETAM - LEVETIRACETAM A091399 002 LEVETIRACETAM - LEVETIRACETAM A091430 001 LEVETIRACETAM - LEVETIRACETAM A091430 002 LEVETIRACETAM - LEVETIRACETAM A091557 001 LEVETIRACETAM - LEVETIRACETAM A091557 002 LEVOBETAXOLOL HYDROCHLORIDE - BETAXON N021114 001 5540918 Jul 30, 2013 5540918*PED Jan 30, 2014 LEVOBUPIVACAINE HYDROCHLORIDE - CHIROCAINE N020997 001 5708011 Oct 13, 2014 LEVOBUPIVACAINE HYDROCHLORIDE - CHIROCAINE N020997 002 5708011 Oct 13, 2014 LEVOBUPIVACAINE HYDROCHLORIDE - CHIROCAINE N020997 003 5708011 Oct 13, 2014 LEVOCARNITINE - CARNITOR N020182 001 6335369 6429230 6696493

25, 20, 25, 17, 08,

2013 2013 2014 2015 2024

U-636 U-636 DP DP DP

DS

U-636

Sep

17, 2028

DP

NDF

Sep

12, 2011

Sep

17, 2028

DP

NDF

Sep

12, 2011

PC

Mar

10, 2012

PC

Mar

10, 2012

PC

Mar

10, 2012

PC

Mar

10, 2012

PC

Mar

10, 2012

PC

Mar

10, 2012

PC

Mar

10, 2012

PC

Mar

10, 2012

PC

Mar

10, 2012

PC

Mar

10, 2012

PC

Mar

10, 2012

PC DP

Mar

10, 2012

U-276

U-276

U-276

Jan Jan Jan

18, 2021 18, 2021 18, 2021

U-433 U-433 U-433

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 108 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-812

EXCLUSIVITY CODE(S)
NPP PED

LEVOCETIRIZINE DIHYDROCHLORIDE - XYZAL Sep 24, 2012 N022064 001 5698558 Mar 24, 2013 5698558*PED LEVOCETIRIZINE DIHYDROCHLORIDE - XYZAL Sep 24, 2012 N022157 001 5698558 Mar 24, 2013 5698558*PED LEVOFLOXACIN - LEVAQUIN N021721 001 6806256 6806256*PED

Aug Feb

21, 2012 21, 2013

U-852

NPP PED

Aug Feb

21, 2012 21, 2013

Feb Aug

26, 2022 26, 2022

DP

LEVOLEUCOVORIN CALCIUM - FUSILEV N020140 001 6500829 Dec

31, 2019

DS

DP

I-637 ODE ODE

Apr Apr Mar

29, 2014 29, 2018 07, 2015

LEVOLEUCOVORIN CALCIUM - FUSILEV N020140 002 6500829 Dec

31, 2019

DS

DP

I-637 ODE ODE

Apr Apr Mar

29, 2014 29, 2018 07, 2015

LEVOLEUCOVORIN CALCIUM - FUSILEV N020140 003 6500829 Dec

31, 2019

DS

DP

I-637 ODE ODE

Apr Apr Mar

29, 2014 29, 2018 07, 2015

LEVONORGESTREL - MIRENA N021225 001 5785053

Dec

05, 2015

DP

I-610

Oct

01, 2012

LEVONORGESTREL - PLAN B ONE-STEP N021998 001 LEVOTHYROXINE SODIUM - LEVO-T N021342 001 6399101 LEVOTHYROXINE SODIUM - LEVO-T N021342 002 6399101 LEVOTHYROXINE SODIUM - LEVO-T N021342 003 6399101 LEVOTHYROXINE SODIUM - LEVO-T N021342 004 6399101 LEVOTHYROXINE SODIUM - LEVO-T N021342 005 6399101 LEVOTHYROXINE SODIUM - LEVO-T N021342 006 6399101 LEVOTHYROXINE SODIUM - LEVO-T N021342 007 6399101 LEVOTHYROXINE SODIUM - LEVO-T N021342 008 6399101 LEVOTHYROXINE SODIUM - LEVO-T N021342 009 6399101 LEVOTHYROXINE SODIUM - LEVO-T N021342 010 6399101 LEVOTHYROXINE SODIUM - LEVO-T N021342 011 6399101

NP 30, 2020

Jul

10, 2012

Mar

Mar

30, 2020

Mar

30, 2020

Mar

30, 2020

Mar

30, 2020

Mar

30, 2020

Mar

30, 2020

Mar

30, 2020

Mar

30, 2020

Mar

30, 2020

Mar

30, 2020

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 109 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)

LEVOTHYROXINE SODIUM - LEVOXYL Feb N021301 001 6555581 Feb 7067148 Aug 7101569 LEVOTHYROXINE SODIUM - LEVOXYL N021301 002 6555581 Feb 7067148 Feb 7101569 Aug LEVOTHYROXINE SODIUM - LEVOXYL Feb N021301 003 6555581 Feb 7067148 Aug 7101569 LEVOTHYROXINE SODIUM - LEVOXYL N021301 004 6555581 Feb 7067148 Feb 7101569 Aug LEVOTHYROXINE SODIUM - LEVOXYL Feb N021301 005 6555581 Feb 7067148 Aug 7101569 LEVOTHYROXINE SODIUM - LEVOXYL Feb N021301 006 6555581 Feb 7067148 Aug 7101569 LEVOTHYROXINE SODIUM - LEVOXYL N021301 007 6555581 Feb 7067148 Feb 7101569 Aug LEVOTHYROXINE SODIUM - LEVOXYL Feb N021301 008 6555581 Feb 7067148 Aug 7101569 LEVOTHYROXINE SODIUM - LEVOXYL Feb N021301 009 6555581 Feb 7067148 Aug 7101569 LEVOTHYROXINE SODIUM - LEVOXYL N021301 010 6555581 Feb 7067148 Feb 7101569 Aug LEVOTHYROXINE SODIUM - LEVOXYL Feb N021301 011 6555581 Feb 7067148 Aug 7101569 LEVOTHYROXINE SODIUM - LEVOXYL Feb N021301 012 6555581 Feb 7067148 Aug 7101569 LEVOTHYROXINE SODIUM - TIROSINT N021924 002 7723390 Mar LEVOTHYROXINE SODIUM - TIROSINT N021924 003 7723390 Mar LEVOTHYROXINE SODIUM - TIROSINT N021924 004 7723390 Mar LEVOTHYROXINE SODIUM - TIROSINT N021924 005 7723390 Mar

15, 2022 15, 2022 14, 2022

DP U-759

15, 2022 15, 2022 14, 2022

DP U-759

15, 2022 15, 2022 14, 2022

DP U-759

15, 2022 15, 2022 14, 2022

DP U-759

15, 2022 15, 2022 14, 2022

DP U-759

15, 2022 15, 2022 14, 2022

DP U-759

15, 2022 15, 2022 14, 2022

DP U-759

15, 2022 15, 2022 14, 2022

DP U-759

15, 2022 15, 2022 14, 2022

DP U-759

15, 2022 15, 2022 14, 2022

DP U-759

15, 2022 15, 2022 14, 2022

DP U-759

15, 2022 15, 2022 14, 2022

DP U-759

14, 2024

DP

14, 2024

DP

14, 2024

DP

14, 2024

DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 110 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DP

EXCLUSIVITY CODE(S)

LEVOTHYROXINE SODIUM - TIROSINT N021924 006 7723390 Mar LEVOTHYROXINE SODIUM - TIROSINT N021924 007 7723390 Mar LEVOTHYROXINE SODIUM - TIROSINT N021924 008 7723390 Mar LEVOTHYROXINE SODIUM - TIROSINT N021924 009 7723390 Mar LEVOTHYROXINE SODIUM - TIROSINT N021924 010 7723390 Mar LEVOTHYROXINE SODIUM - TIROSINT N022121 001 7723390 Mar LIDOCAINE - DENTIPATCH N020575 001 5332576 LIDOCAINE - DENTIPATCH N020575 002 5332576 LIDOCAINE - LIDODERM N020612 001 5411738 5601838 5741510 5827529 LIDOCAINE HYDROCHLORIDE - AKTEN N022221 001 LIDOCAINE HYDROCHLORIDE - ZINGO May N022114 001 5630796 May 5899880 Mar 6004286 Jun 6881200 LIDOCAINE; PRILOCAINE - ORAQIX Apr N021451 001 6031007

14, 2024

14, 2024

DP

14, 2024

DP

14, 2024

DP

14, 2024

DP

14, 2024

DP

Jul

26, 2011

Jul

26, 2011

May May Mar Oct

02, 02, 30, 27,

2012 2012 2014 2015

U-488 DP U-486

NDF 20, 04, 17, 11, 2014 2016 2017 2016

Oct

07, 2011

NPP DP DP DP

Jan

08, 2012

01, 2017

DP

U-553

LIDOCAINE; TETRACAINE - LIDOCAINE AND TETRACAINE N021717 001 5919479 Jul 28, 2015 6528086 Sep 28, 2019 LIDOCAINE; TETRACAINE - SYNERA N021623 001 5658583 Jul 5919479 Jul 6306431 Jul 6465006 Jul 6546281 Jul 6780426 Jul LINAGLIPTIN - TRADJENTA N201280 001 6303661 6890898 7078381 7407955 7459428 LINEZOLID - ZYVOX N021130 001 5688792 5688792*PED 6514529 6514529*PED 6559305 6559305*PED

DP DP

28, 28, 28, 28, 28, 28,

2015 2015 2015 2015 2015 2015

DP DP DP DP DP DP

Apr Feb Feb Aug Feb

24, 02, 02, 12, 02,

2017 2019 2019 2023 2019

U-774 U-493 U-493 DS DP U-493

NCE

May

02, 2016

Nov May Mar Sep Jan Jul

18, 18, 15, 15, 29, 29,

2014 2015 2021 2021 2021 2021

DS DP DS

U-319

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

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PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DS DP DS U-319

EXCLUSIVITY CODE(S)

LINEZOLID - ZYVOX N021130 002 5688792 5688792*PED 6514529 6514529*PED 6559305 6559305*PED LINEZOLID - ZYVOX N021131 001 5688792 5688792*PED 6559305 6559305*PED LINEZOLID - ZYVOX N021132 001 5688792 5688792*PED 6559305 6559305*PED

Nov May Mar Sep Jan Jul

18, 18, 15, 15, 29, 29,

2014 2015 2021 2021 2021 2021

Nov May Jan Jul

18, 18, 29, 29,

2014 2015 2021 2021

U-319 DS

Nov May Jan Jul

18, 18, 29, 29,

2014 2015 2021 2021

DS DS

U-319

LIRAGLUTIDE RECOMBINANT - VICTOZA N022341 001 6268343 Aug Aug 6458924 Aug 7235627

22, 2017 22, 2017 22, 2017

DS DS DS

DP DP DP

U-968 U-968

NCE

Jan

25, 2015

LISDEXAMFETAMINE DIMESYLATE - VYVANSE N021977 001 7105486 Jun 29, 7223735 Jun 29, 7655630 Feb 24, 7659253 Feb 24, 7659254 Feb 24, 7662787 Feb 24, 7671030 Feb 24, 7671031 Feb 28, 7674774 Mar 18, 7678770 Mar 25, 7678771 Mar 25, 7687466 Feb 24, 7687467 Apr 08, Jun 29, 7700561 Feb 24, 7718619 Feb 24, 7723305 LISDEXAMFETAMINE DIMESYLATE - VYVANSE Jun 29, N021977 002 7105486 Jun 29, 7223735 Feb 24, 7655630 Feb 24, 7659253 Feb 24, 7659254 Feb 24, 7662787 Feb 24, 7671030 Feb 28, 7671031 Mar 18, 7674774 Mar 25, 7678770 Mar 25, 7678771 Feb 24, 7687466 Apr 08, 7687467 Jun 29, 7700561 Feb 24, 7718619 Feb 24, 7723305

2023 2023 2023 2023 2023 2023 2023 2023 2023 2023 2023 2023 2023 2023 2023 2023

U-727 DP DS DS DS DP DP DP DP DP DP DP DP U-727 U-727 U-842 U-842 U-842 U-842 U-842 U-842 DP U-727 U-1034

M-82 NPP NCE

Apr Nov Feb

05, 2013 10, 2013 23, 2012

2023 2023 2023 2023 2023 2023 2023 2023 2023 2023 2023 2023 2023 2023 2023 2023

U-727 DP DS DS DS DP DP DP DP DP DP DP DP U-727 U-727 U-842 U-842 U-842 U-842 U-842 U-842 DP U-727 U-1034

M-82 NPP NCE

Apr Nov Feb

05, 2013 10, 2013 23, 2012

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 112 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-727 DP DS DS DS DP DP DP DP DP DP DP DP U-727 U-727 U-842 U-842 U-842 U-842 U-842 U-842 DP U-727 U-1034

EXCLUSIVITY CODE(S)
M-82 NPP NCE

LISDEXAMFETAMINE DIMESYLATE - VYVANSE Jun 29, N021977 003 7105486 Jun 29, 7223735 Feb 24, 7655630 Feb 24, 7659253 Feb 24, 7659254 Feb 24, 7662787 Feb 24, 7671030 Feb 28, 7671031 Mar 18, 7674774 Mar 25, 7678770 Mar 25, 7678771 Feb 24, 7687466 Apr 08, 7687467 Jun 29, 7700561 Feb 24, 7718619 Feb 24, 7723305 LISDEXAMFETAMINE DIMESYLATE - VYVANSE N021977 004 7105486 Jun 29, 7223735 Jun 29, 7655630 Feb 24, 7659253 Feb 24, 7659254 Feb 24, 7662787 Feb 24, 7671031 Feb 28, 7678770 Mar 25, 7687466 Feb 24, 7700561 Jun 29, LISDEXAMFETAMINE DIMESYLATE - VYVANSE Jun 29, N021977 005 7105486 Jun 29, 7223735 Feb 24, 7655630 Feb 24, 7659253 Feb 24, 7659254 Feb 24, 7662787 Feb 24, 7671030 Feb 28, 7671031 Mar 18, 7674774 Mar 25, 7678770 Mar 25, 7678771 Feb 24, 7687466 Apr 08, 7687467 Jun 29, 7700561 Feb 24, 7718619 Feb 24, 7723305 LISDEXAMFETAMINE DIMESYLATE - VYVANSE N021977 006 7105486 Jun 29, 7223735 Jun 29, 7655630 Feb 24, 7659253 Feb 24, 7659254 Feb 24, 7662787 Feb 24, 7671030 Feb 24, 7671031 Feb 28, 7674774 Mar 18, 7678770 Mar 25, 7678771 Mar 25, 7687466 Feb 24, 7687467 Apr 08, Jun 29, 7700561 Feb 24, 7718619 Feb 24, 7723305 LODOXAMIDE TROMETHAMINE - ALOMIDE N020191 001 5457126 Oct

2023 2023 2023 2023 2023 2023 2023 2023 2023 2023 2023 2023 2023 2023 2023 2023

Apr Nov Feb

05, 2013 10, 2013 23, 2012

2023 2023 2023 2023 2023 2023 2023 2023 2023 2023

U-842 DP DS DS DS U-727 U-842 DP DP DP U-727 U-1034

M-82 NPP NCE

Apr Nov Feb

05, 2013 10, 2013 23, 2012

2023 2023 2023 2023 2023 2023 2023 2023 2023 2023 2023 2023 2023 2023 2023 2023

U-842 DP DS DS DS DP DP DP DP DP DP DP DP U-727 U-727 U-842 U-842 U-842 U-842 U-842 U-842 DP U-727 U-1034

M-82 NPP NCE

Apr Nov Feb

05, 2013 10, 2013 23, 2012

2023 2023 2023 2023 2023 2023 2023 2023 2023 2023 2023 2023 2023 2023 2023 2023

U-842 DP DS DS DS DP DP DP DP DP DP DP DP U-727 U-727 U-842 U-842 U-842 U-842 U-842 U-842 DP U-727 U-1034

M-82 NPP NCE

Apr Nov Feb

05, 2013 10, 2013 23, 2012

10, 2012

U-117

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 113 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DP DP

EXCLUSIVITY CODE(S)

LOPERAMIDE HYDROCHLORIDE - IMODIUM A-D EZ CHEWS N020448 001 5489436 Feb 06, 2013 6814978 Aug 26, 2021 LOPERAMIDE HYDROCHLORIDE; SIMETHICONE N020606 001 5489436 Feb 06, 5679376 Oct 21, 5716641 May 21,

IMODIUM MULTI-SYMPTOM RELIEF 2013 Y 2014 2012 U-226 Y

LOPERAMIDE HYDROCHLORIDE; SIMETHICONE - IMODIUM MULTI-SYMPTOM RELIEF N021140 001 6103260 Jul 17, 2017 DP LOPINAVIR; RITONAVIR - KALETRA N021226 001 5541206 5541206*PED 5648497 5648497*PED 5886036 5886036*PED 5914332 5914332*PED 5948436 5948436*PED 6037157 6037157*PED 6232333 6232333*PED 6284767 6284767 6284767*PED 6458818 6458818*PED 6521651 6521651*PED 6703403 6703403*PED 7141593 7141593*PED 7432294 7432294*PED LOPINAVIR; RITONAVIR - KALETRA N021251 001 5484801 5484801*PED 5541206 5541206 5541206*PED 5648497 5648497*PED 5886036 5886036*PED 5914332 5914332 5914332*PED 5948436 5948436*PED 6037157 6037157 6037157*PED 6284767 6284767 6284767*PED 6703403 6703403 6703403*PED 6911214 6911214*PED

Jul Jan Jul Jan Nov May Dec Jun Sep Mar Jun Dec Nov May Feb Feb Aug Nov May Nov May Jun Dec May Nov May Nov

30, 30, 15, 15, 19, 19, 13, 13, 13, 13, 26, 26, 07, 07, 15, 15, 15, 07, 07, 07, 07, 26, 26, 22, 22, 22, 22,

2013 2014 2014 2015 2013 2014 2015 2016 2013 2014 2016 2016 2017 2018 2016 2016 2016 2017 2018 2017 2018 2016 2016 2020 2020 2020 2020

DS

U-348

DS

DP U-351 DP U-346

DP DP

U-688 U-401

DP U-257 DP DP

Jan Jul Jul Jul Jan Jul Jan Nov May Dec Dec Jun Sep Mar Jun Jun Dec Feb Feb Aug Jun Jun Dec Nov May

28, 28, 30, 30, 30, 15, 15, 19, 19, 13, 13, 13, 13, 13, 26, 26, 26, 15, 15, 15, 26, 26, 26, 28, 28,

2014 2014 2013 2013 2014 2014 2015 2013 2014 2015 2015 2016 2013 2014 2016 2016 2016 2016 2016 2016 2016 2016 2016 2021 2022

DP DS DS DS DS DS DS DP DP DP DP U-895 U-346 DP DP U-895 U-401 U-257 U-895 DP U-895 U-895 U-895 U-351 DP DP U-348 U-895

D-124

Apr

27, 2013

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 114 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DS DS DS DS DP DP DP DP U-895 U-688 U-688 DP U-688 U-688 DP DP DP U-688 U-688

EXCLUSIVITY CODE(S)
D-124

LOPINAVIR; RITONAVIR - KALETRA N021906 001 5541206 5541206*PED 5648497 5648497*PED 5886036 5886036*PED 5914332 5914332*PED 6037157 6037157*PED 6284767 6284767*PED 6703403 6703403*PED 7148359 7148359*PED 7364752 7364752*PED 8025899 8025899*PED LOPINAVIR; RITONAVIR - KALETRA N021906 002 5541206 5541206*PED 5648497 5648497*PED 5886036 5886036*PED 5914332 5914332*PED 6037157 6037157*PED 6284767 6284767*PED 6703403 6703403*PED 7148359 7148359*PED 7364752 7364752*PED 8025899 8025899*PED LORATADINE - CLARITIN N020641 002 6132758

Jul Jan Jul Jan Nov May Dec Jun Jun Dec Feb Aug Jun Dec Jul Jan Nov May Sep Mar

30, 30, 15, 15, 19, 19, 13, 13, 26, 26, 15, 15, 26, 26, 19, 19, 10, 10, 26, 26,

2013 2014 2014 2015 2013 2014 2015 2016 2016 2016 2016 2016 2016 2016 2019 2020 2020 2021 2027 2028

Apr

27, 2013

Jul Jan Jul Jan Nov May Dec Jun Jun Dec Feb Aug Jun Dec Jul Jan Nov May Sep Mar

30, 30, 15, 15, 19, 19, 13, 13, 26, 26, 15, 15, 26, 26, 19, 19, 10, 10, 26, 26,

2013 2014 2014 2015 2013 2014 2015 2016 2016 2016 2016 2016 2016 2016 2019 2020 2020 2021 2027 2028

DS DS DS DS

DP DP DP DP

U-688

D-124

Apr

27, 2013

U-895 U-688 U-688

DP

U-688 U-688

DP DP DP U-688

Jun

01, 2018

LORATADINE; PSEUDOEPHEDRINE SULFATE - CLARITIN-D 24 HOUR N020470 002 5314697 Oct 23, 2012 LOTEPREDNOL ETABONATE - ALREX N020803 001 4996335 4996335*PED 5540930 5540930*PED 5747061 5747061*PED

Mar Sep Oct Apr Oct Apr

09, 09, 25, 25, 25, 25,

2012 2012 2013 2014 2013 2014

DP

U-576

LOTEPREDNOL ETABONATE - LOTEMAX N020583 001 4996335 Mar 4996335*PED Sep 5540930 Oct 5540930*PED Apr 5747061 Oct 5747061*PED Apr LOTEPREDNOL ETABONATE - LOTEMAX N020841 001 5540930 Oct

09, 09, 25, 25, 25, 25,

2012 2012 2013 2014 2013 2014

DP

U-575

25, 2013

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 115 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)
NDF PED

LOTEPREDNOL ETABONATE - LOTEMAX N200738 001 LOTEPREDNOL ETABONATE; TOBRAMYCIN N050804 001 4996335 Mar 4996335*PED Sep Oct 5540930 Apr 5540930*PED Oct 5747061 Apr 5747061*PED LOVASTATIN - ALTOPREV N021316 001 5916595 6080778 6485748 LOVASTATIN - ALTOPREV N021316 002 5916595 6080778 6485748 LOVASTATIN - ALTOPREV N021316 003 5916595 6080778 6485748 LOVASTATIN - ALTOPREV N021316 004 5916595 6080778 6485748 LOVASTATIN; NIACIN - ADVICOR N021249 001 6080428 6080428 6080428 6080428 6129930 6129930 6129930 6129930 6406715 6469035 6469035 6469035 6469035 6676967 6676967 6676967 6676967 6746691 6818229 7011848 7011848 7011848 7011848 7998506 7998506 7998506 ZYLET 09, 2012 09, 2012 25, 2013 25, 2014 25, 2013 25, 2014

Apr Oct

15, 2014 15, 2014

DS

DP DP DP

U-920

U-920

Dec Mar Dec

12, 2017 23, 2018 12, 2017

U-456 DP

Dec Mar Dec

12, 2017 23, 2018 12, 2017

U-456 DP

Dec Mar Dec

12, 2017 23, 2018 12, 2017

U-456 DP

Dec Mar Dec

12, 2017 23, 2018 12, 2017

U-456 DP

May May May May Sep Sep Sep Sep Sep Mar Mar Mar Mar Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep

27, 27, 27, 27, 20, 20, 20, 20, 20, 15, 15, 15, 15, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20,

2017 2017 2017 2017 2013 2013 2013 2013 2013 2018 2018 2018 2018 2013 2013 2013 2013 2013 2013 2013 2013 2013 2013 2013 2013 2013

DP DP DP DP DP

DP DP

U-1134 U-1133 U-447 U-1132 U-1134 U-1133 U-448 U-1132 U-450 U-1131 U-768 U-1130 U-1129 U-548 U-1133 U-1132 U-1134 U-586 U-1136 U-1137 U-712 U-1135 U-1135 U-1136 U-1137

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 116 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-1134 U-1132 U-1133 U-447 U-448 U-1132 U-1134 U-1133 U-450 U-1129 U-768 U-1131 U-1130 U-1134 U-548 U-1133 U-1132 U-586 U-712 U-1135 U-1137 U-1136 U-1135 U-1136 U-1137

EXCLUSIVITY CODE(S)

LOVASTATIN; NIACIN - ADVICOR N021249 002 6080428 6080428 6080428 6080428 6129930 6129930 6129930 6129930 6406715 6469035 6469035 6469035 6469035 6676967 6676967 6676967 6676967 6746691 6818229 7011848 7011848 7011848 7011848 7998506 7998506 7998506 LOVASTATIN; NIACIN - ADVICOR N021249 003 6080428 6080428 6080428 6080428 6129930 6129930 6129930 6129930 6406715 6469035 6469035 6469035 6469035 6676967 6676967 6676967 6676967 6746691 6818229 7011848 7011848 7011848 7011848 7998506 7998506 7998506

May May May May Sep Sep Sep Sep Sep Mar Mar Mar Mar Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep

27, 27, 27, 27, 20, 20, 20, 20, 20, 15, 15, 15, 15, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20,

2017 2017 2017 2017 2013 2013 2013 2013 2013 2018 2018 2018 2018 2013 2013 2013 2013 2013 2013 2013 2013 2013 2013 2013 2013 2013

DP DP DP DP DP

DP DP

May May May May Sep Sep Sep Sep Sep Mar Mar Mar Mar Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep

27, 27, 27, 27, 20, 20, 20, 20, 20, 15, 15, 15, 15, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20,

2017 2017 2017 2017 2013 2013 2013 2013 2013 2018 2018 2018 2018 2013 2013 2013 2013 2013 2013 2013 2013 2013 2013 2013 2013 2013

DP DP DP DP DP

DP DP

U-1133 U-1134 U-447 U-1132 U-1133 U-1134 U-1132 U-448 U-450 U-1131 U-1129 U-768 U-1130 U-1132 U-1134 U-1133 U-548 U-586 U-1136 U-712 U-1137 U-1135 U-1135 U-1137 U-1136

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 117 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-1134 U-1132 U-1133 U-447 U-1133 U-1132 U-1134 U-448 U-1130 U-1129 U-1131 U-768 U-548 U-1132 U-1134 U-1133 U-586 U-1137 U-712 U-1136 U-1135 U-1135 U-1136 U-1137

EXCLUSIVITY CODE(S)

LOVASTATIN; NIACIN - ADVICOR N021249 004 6080428 6080428 6080428 6080428 6129930 6129930 6129930 6129930 6406715 6469035 6469035 6469035 6469035 6676967 6676967 6676967 6676967 6746691 6818229 7011848 7011848 7011848 7011848 7998506 7998506 7998506 LUBIPROSTONE - AMITIZA N021908 001 5284858 6414016 6583174 7064148 7417067 8026393 8071613 8088934 LUBIPROSTONE - AMITIZA N021908 002 5284858 6414016 6583174 7064148 7064148 7417067 7795312 8026393 8071613 8088934

May May May May Sep Sep Sep Sep Sep Mar Mar Mar Mar Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep

27, 27, 27, 27, 20, 20, 20, 20, 20, 15, 15, 15, 15, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20,

2017 2017 2017 2017 2013 2013 2013 2013 2013 2018 2018 2018 2018 2013 2013 2013 2013 2013 2013 2013 2013 2013 2013 2013 2013 2013

DP DP DP DP DP

DP DP

Jul Sep Oct Aug Oct Oct Sep May

14, 05, 16, 30, 16, 25, 05, 18,

2014 2020 2020 2022 2020 2027 2020 2021

DS U-717 DP U-739 DP DP U-1203 DS

Jul Sep Oct Aug Aug Oct Sep Oct Sep May

14, 05, 16, 30, 30, 16, 17, 25, 05, 18,

2014 2020 2020 2022 2022 2020 2024 2027 2020 2021

DS U-874 DP U-739 U-873 DP U-1085 DP U-1202 DS

LURASIDONE HYDROCHLORIDE - LATUDA N200603 001 5532372 Jul LURASIDONE HYDROCHLORIDE - LATUDA N200603 002 5532372 Jul LUTROPIN ALFA - LUVERIS N021322 001 5767251

02, 2013

DS

NCE

Oct

28, 2015

02, 2013

DS

NCE

Oct

28, 2015

Jun

16, 2015

DS

ODE

Oct

08, 2011

MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE - NORMOCARB HF 25 N021910 001 5945449 Oct 31, 2017 DP U-785 7300674 Mar 04, 2023 DP U-785 MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE - NORMOCARB HF 35 N021910 002 5945449 Oct 31, 2017 DP U-785

ODE

Jul

26, 2013

ODE

Jul

26, 2013

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 118 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)

MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE N022456 001 6489346 Jul 16, 6489346 Jul 16, 6645988 Jul 16, 6699885 Jul 16, 6699885 Jul 16, 7399772 Jul 16, 7399772 Jul 16, MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE N022456 002 6489346 Jul 16, 6489346 Jul 16, 6645988 Jul 16, 6699885 Jul 16, 6699885 Jul 16, 7399772 Jul 16, 7399772 Jul 16, MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM N021850 001 6489346 Jul 16, 6645988 Jul 16, 6699885 Jul 16, 7399772 Jul 16, MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM N021850 002 6489346 Jul 16, 6645988 Jul 16, 6699885 Jul 16, 7399772 Jul 16,

BICARBONATE - MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM 2016 2016 2016 2016 2016 2016 2016 DP DP DP DP DP DP DP U-588 U-1021 U-588 U-1021 U-1021 U-588

BICARBONATE - MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM 2016 2016 2016 2016 2016 2016 2016 DP DP DP DP DP DP DP U-1021 U-588 U-588 U-1021 U-588 U-1021

BICARBONATE - ZEGERID 2016 DS DP U-588 DS DP U-588 2016 U-588 2016 2016 U-588 BICARBONATE - ZEGERID 2016 DS DP U-623 DS DP U-623 2016 2016 U-623 U-623 2016

MAGNESIUM SULFATE ANHYDROUS; POTASSIUM SULFATE; SODIUM SULFATE - SUPREP BOWEL PREP KIT N022372 001 6946149 Apr 30, 2022 DP U-837 NC MALATHION - OVIDE N018613 001 7560445 7977324

Aug

05, 2013

Feb Aug

01, 2027 14, 2026

DS

DP DP

U-986

MANGAFODIPIR TRISODIUM - TESLASCAN N020652 001 4933456 Nov MANNITOL - ARIDOL KIT N022368 001 5817028 MARAVIROC - SELZENTRY N022128 001 6586430 6667314 7368460 7576097 MARAVIROC - SELZENTRY N022128 002 6586430 6667314 7368460 7576097

27, 2011

Feb

23, 2015

U-1091

NP

Oct

05, 2013

Dec Aug Nov May

01, 06, 25, 25,

2019 2021 2022 2021

DS DS DS

DP DP

U-824 U-824 U-824

NPP NCE

May Aug

28, 2013 06, 2012

Dec Aug Nov May

01, 06, 25, 25,

2019 2021 2022 2021

DS DS DS

DP DP

U-824 U-824 U-824

NPP NCE

May Aug

28, 2013 06, 2012

MECASERMIN RECOMBINANT - INCRELEX N021839 001 5681814 Sep 5824642 Jul 6207640 Apr

18, 2017 08, 2014 07, 2014

DP U-681 U-681

ODE

Aug

30, 2012

MECASERMIN RINFABATE RECOMBINANT - IPLEX N021884 001 5681818 Oct 28, 2014 MEDROXYPROGESTERONE ACETATE - DEPO-SUBQ PROVERA 104 DP N021583 001 6495534 May 15, 2020 MEGESTROL ACETATE - MEGACE N020264 001 5338732

U-697

ODE

Dec

12, 2012

Aug

16, 2011

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 119 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DP U-755

EXCLUSIVITY CODE(S)

MEGESTROL ACETATE - MEGACE ES N021778 001 6592903 7101576 MELOXICAM - MOBIC N020938 001 MELOXICAM - MOBIC N020938 002 MELOXICAM - MOBIC N021530 001 6184220 6184220*PED

Sep Apr

21, 2020 22, 2024

ODE PED

Aug Feb

11, 2012 11, 2013

ODE PED Mar Sep 25, 2019 25, 2019 DP

Aug Feb

11, 2012 11, 2013

ODE PED U-539

Aug Feb

11, 2012 11, 2013

MEMANTINE HYDROCHLORIDE - NAMENDA N021487 001 5061703 Apr MEMANTINE HYDROCHLORIDE - NAMENDA Apr N021487 002 5061703 MEMANTINE HYDROCHLORIDE - NAMENDA Apr N021627 001 5061703

11, 2015

11, 2015

U-539

11, 2015

U-539

MEMANTINE HYDROCHLORIDE - NAMENDA XR N022525 001 5061703 Apr 11, 2015 8039009 Mar 24, 2029 MEMANTINE HYDROCHLORIDE - NAMENDA XR Apr 11, 2015 N022525 002 5061703 Mar 24, 2029 8039009 MEMANTINE HYDROCHLORIDE - NAMENDA XR Apr 11, 2015 N022525 003 5061703 Mar 24, 2029 8039009 MEMANTINE HYDROCHLORIDE - NAMENDA XR Apr 11, 2015 N022525 004 5061703 Mar 24, 2029 8039009 MEQUINOL; TRETINOIN - SOLAGE N020922 001 5194247 6353029 MESALAMINE - APRISO N022301 001 6551620 MESALAMINE - ASACOL N019651 001 5541170 5541171 MESALAMINE - ASACOL HD N021830 001 5541170 5541171 6893662 MESALAMINE - LIALDA N022000 001 6773720 MESALAMINE - SFROWASA N019618 002 7645801 MESNA - MESNEX N020855 001 5252341 5262169 METAXALONE - SKELAXIN N013217 001 6407128 6683102

U-539 U-539

NDF

Jun

21, 2013

U-539 U-539

NDF

Jun

21, 2013

U-539 U-539

NDF

Jun

21, 2013

U-539 U-539

NDF

Jun

21, 2013

Dec Aug

10, 2013 24, 2020

DP

U-294

Apr

20, 2018

DS

DP

U-907

NP

Oct

31, 2011

Jul Jul

30, 2013 30, 2013

U-141 U-141

Jul Jul Nov

30, 2013 30, 2013 15, 2021

DP DP DP

U-141 U-141 U-141

Jun

08, 2020

DP

I-640

Jul

14, 2014

Jul

24, 2027

DS

DP

Jul Jul

16, 2011 16, 2011

Dec Dec

03, 2021 03, 2021

U-189 U-189

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 120 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-189 U-189 U-915 U-1050

EXCLUSIVITY CODE(S)

METAXALONE - SKELAXIN N013217 003 6407128 6683102 7122566 7714006

Dec Dec Feb Dec

03, 03, 06, 03,

2021 2021 2026 2021

METFORMIN HYDROCHLORIDE - FORTAMET N021574 001 6099859 Mar 6495162 Mar 6790459 Mar 6866866 Mar 7919116 Mar METFORMIN HYDROCHLORIDE - FORTAMET N021574 002 6099859 Mar 6495162 Mar 6790459 Mar 6866866 Mar 7919116 Mar

20, 20, 17, 17, 20,

2018 2018 2021 2021 2018

DP DP U-604 DP DP

20, 20, 17, 17, 20,

2018 2018 2021 2021 2018

DP DP U-604 DP DP

METFORMIN HYDROCHLORIDE - GLUCOPHAGE XR N021202 001 6475521 Mar 19, 2018 6660300 Mar 19, 2018 METFORMIN HYDROCHLORIDE - GLUCOPHAGE XR N021202 004 6475521 Mar 19, 2018 6660300 Mar 19, 2018 METFORMIN HYDROCHLORIDE - GLUMETZA N021748 001 6340475 Sep 6488962 Jun 6635280 Sep Oct 6723340 METFORMIN HYDROCHLORIDE - GLUMETZA N021748 002 6488962 Jun 7780987 Mar

U-542

U-542

19, 20, 19, 25,

2016 2020 2016 2021

DS DS DS DS

DP DP DP DP

U-669

20, 2020 23, 2025

DS DS

DP DP

METFORMIN HYDROCHLORIDE - METFORMIN HYDROCHLORIDE A090692 001 METFORMIN HYDROCHLORIDE - METFORMIN HYDROCHLORIDE A090692 002 METFORMIN HYDROCHLORIDE - RIOMET Sep N021591 001 6890957

PC

Mar

28, 2012

PC DP

Mar

28, 2012

14, 2023

METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE - ACTOPLUS MET N021842 001 5965584 DP U-1055 Jun 19, 2016 U-679 6166042 Jun 19, 2016 U-679 6166043 Jun 19, 2016 U-679 6172090 Jun 19, 2016 METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE - ACTOPLUS MET DP U-1055 N021842 002 5965584 Jun 19, 2016 U-679 6166042 Jun 19, 2016 U-679 6166043 Jun 19, 2016 U-679 6172090 Jun 19, 2016

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

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PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)

METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE N022024 001 5965584 Jun 19, 2016 6099859 Mar 20, 2018 6166042 Jun 19, 2016 6166043 Jun 19, 2016 6172090 Jun 19, 2016 6495162 Mar 20, 2018 6790459 Mar 17, 2021 6866866 Mar 17, 2021 7785627 Jul 31, 2026 7919116 Mar 20, 2018 7919116 Mar 20, 2018 7959946 Jul 31, 2026 METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE N022024 002 5965584 Jun 19, 2016 6099859 Mar 20, 2018 6166042 Jun 19, 2016 6166043 Jun 19, 2016 6172090 Jun 19, 2016 6495162 Mar 20, 2018 6790459 Mar 17, 2021 6866866 Mar 17, 2021 7785627 Jul 31, 2026 7919116 Mar 20, 2018 7919116 Mar 20, 2018 7959946 Jul 31, 2026 METFORMIN HYDROCHLORIDE; REPAGLINIDE - PRANDIMET N022386 001 6677358 Jun 12, 2018 METFORMIN HYDROCHLORIDE; REPAGLINIDE - PRANDIMET N022386 002 6677358 Jun 12, 2018

- ACTOPLUS MET XR DP U-973 DP U-973 U-973 U-973 DP U-974 DP DP U-973 U-1120 DP - ACTOPLUS MET XR DP U-973 DP U-973 U-973 U-973 DP U-974 DP DP U-973 U-1120 DP

DP

U-546

DP

U-546

METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE - AVANDAMET DS DP U-493 N021410 001 5002953 Sep 17, 2011 Sep 17, 2011 DS DP U-690 5002953 DS DP U-691 Sep 17, 2011 5002953 Sep 17, 2011 DS DP U-734 5002953 Mar 17, 2012 5002953*PED DS DP U-734 Apr 21, 2015 5741803 DS DP U-493 Apr 21, 2015 5741803 Oct 21, 2015 5741803*PED U-493 Jun 19, 2016 5965584 U-493 Jun 19, 2016 6166042 U-493 Feb 11, 2017 6288095 Aug 11, 2017 6288095*PED Apr 19, 2020 DS 7358366 Oct 19, 2020 7358366*PED METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE - AVANDAMET DS DP U-690 N021410 002 5002953 Sep 17, 2011 5002953 Sep 17, 2011 DS DP U-691 Sep 17, 2011 DS DP U-734 5002953 DS DP U-493 Sep 17, 2011 5002953 Mar 17, 2012 5002953*PED DS DP U-493 Apr 21, 2015 5741803 Apr 21, 2015 DS DP U-734 5741803 Oct 21, 2015 5741803*PED Jun 19, 2016 U-493 5965584 U-493 Jun 19, 2016 6166042 U-493 Feb 11, 2017 6288095 Aug 11, 2017 6288095*PED DS Apr 19, 2020 7358366 Oct 19, 2020 7358366*PED

Y Y Y Y Y

Y Y Y Y Y

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

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PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)

METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE - AVANDAMET DS DP U-493 N021410 003 5002953 Sep 17, 2011 Sep 17, 2011 DS DP U-691 5002953 DS DP U-690 Sep 17, 2011 5002953 Sep 17, 2011 DS DP U-734 5002953 Mar 17, 2012 5002953*PED DS DP U-493 Apr 21, 2015 5741803 DS DP U-734 Apr 21, 2015 5741803 Oct 21, 2015 5741803*PED U-493 Jun 19, 2016 5965584 U-493 Jun 19, 2016 6166042 U-493 Feb 11, 2017 6288095 Aug 11, 2017 6288095*PED Apr 19, 2020 DS 7358366 Oct 19, 2020 7358366*PED METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE - AVANDAMET DS DP U-690 N021410 004 5002953 Sep 17, 2011 Sep 17, 2011 DS DP U-691 5002953 Sep 17, 2011 DS DP U-734 5002953 DS DP U-493 Sep 17, 2011 5002953 Mar 17, 2012 5002953*PED DS DP U-493 Apr 21, 2015 5741803 DS DP U-734 Apr 21, 2015 5741803 Oct 21, 2015 5741803*PED DS Apr 19, 2020 7358366 Oct 19, 2020 7358366*PED METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE - AVANDAMET N021410 005 5002953 Sep 17, 2011 DS DP U-493 DS DP U-691 5002953 Sep 17, 2011 Sep 17, 2011 DS DP U-690 5002953 DS DP U-734 Sep 17, 2011 5002953 Mar 17, 2012 5002953*PED DS DP U-493 Apr 21, 2015 5741803 DS DP U-734 Apr 21, 2015 5741803 Oct 21, 2015 5741803*PED DS Apr 19, 2020 7358366 Oct 19, 2020 7358366*PED METFORMIN HYDROCHLORIDE; SAXAGLIPTIN - KOMBIGLYZE XR N200678 001 6395767 Feb 16, 2021 DS DP METFORMIN HYDROCHLORIDE; SAXAGLIPTIN - KOMBIGLYZE XR DS DP N200678 002 6395767 Feb 16, 2021 METFORMIN HYDROCHLORIDE; SAXAGLIPTIN - KOMBIGLYZE XR DS DP N200678 003 6395767 Feb 16, 2021

Y Y Y Y Y

Y Y

Y Y

U-1097

NCE

Jul

31, 2014

U-1097

NCE

Jul

31, 2014

U-1097

NCE

Jul

31, 2014

METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE - JANUMET U-802 N022044 001 6303661 Apr 24, 2017 DS DP U-802 6699871 Jul 26, 2022 U-803 6890898 Feb 02, 2019 U-1036 6890898 Feb 02, 2019 U-1038 6890898 Feb 02, 2019 U-803 7078381 Feb 02, 2019 U-1038 7078381 Feb 02, 2019 U-1036 7078381 Feb 02, 2019 DP U-1038 7125873 Jul 26, 2022 DP U-1036 7125873 Jul 26, 2022 DP U-803 7125873 Jul 26, 2022 DS DP U-802 7326708 Apr 11, 2026

NCE

Oct

16, 2011

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 123 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)
NCE

METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE - JANUMET U-802 N022044 002 6303661 Apr 24, 2017 DS DP U-802 6699871 Jul 26, 2022 U-803 6890898 Feb 02, 2019 U-1038 6890898 Feb 02, 2019 6890898 Feb 02, 2019 U-1036 U-1038 7078381 Feb 02, 2019 U-1036 7078381 Feb 02, 2019 U-803 7078381 Feb 02, 2019 DP U-1036 7125873 Jul 26, 2022 7125873 Jul 26, 2022 DP U-1038 DP U-803 7125873 Jul 26, 2022 DS DP U-802 7326708 Apr 11, 2026 METHYL AMINOLEVULINATE HYDROCHLORIDE - METVIXIA N021415 001 6034267 Mar 08, 2016 METHYLNALTREXONE BROMIDE - RELISTOR N021964 001 6559158 Nov 03, 2017 METHYLNALTREXONE BROMIDE - RELISTOR N021964 002 6559158 Nov 03, 2017 METHYLPHENIDATE - DAYTRANA N021514 001 5958446 6210705 6348211 METHYLPHENIDATE - DAYTRANA N021514 002 5958446 6210705 6348211 METHYLPHENIDATE - DAYTRANA N021514 003 5958446 6210705 6348211 METHYLPHENIDATE - DAYTRANA N021514 004 5958446 6210705 6348211

Oct

16, 2011

U-804

U-1185

NCE

Apr

24, 2013

U-1185

NCE

Apr

24, 2013

Dec Sep Sep

12, 2012 30, 2018 30, 2018

DP DP DP

NPP U-727 U-727

Jun

29, 2013

Dec Sep Sep

12, 2012 30, 2018 30, 2018

DP DP DP

NPP U-727 U-727

Jun

29, 2013

Dec Sep Sep

12, 2012 30, 2018 30, 2018

DP DP DP

NPP U-727 U-727

Jun

29, 2013

Dec Sep Sep

12, 2012 30, 2018 30, 2018

DP DP DP

NPP U-727 U-727

Jun

29, 2013

METHYLPHENIDATE HYDROCHLORIDE - CONCERTA N021121 001 6919373 Jul 31, 2017 6919373*PED Jan 31, 2018 6930129 Jul 31, 2017 6930129*PED Jan 31, 2018 METHYLPHENIDATE HYDROCHLORIDE - CONCERTA N021121 002 6919373 Jul 31, 2017 6919373*PED Jan 31, 2018 6930129 Jul 31, 2017 6930129*PED Jan 31, 2018 METHYLPHENIDATE HYDROCHLORIDE - CONCERTA N021121 003 6919373 Jul 31, 2017 6919373*PED Jan 31, 2018 6930129 Jul 31, 2017 6930129*PED Jan 31, 2018 METHYLPHENIDATE HYDROCHLORIDE - CONCERTA N021121 004 6919373 Jul 31, 2017 6919373*PED Jan 31, 2018 6930129 Jul 31, 2017 6930129*PED Jan 31, 2018 METHYLPHENIDATE HYDROCHLORIDE - METADATE CD N021259 001 6344215 Oct 27, 2020

U-666 U-666

M-88

Nov

04, 2012

U-666 U-666

M-88

Nov

04, 2012

U-666 U-666

M-88

Nov

04, 2012

U-666 U-666

M-88

Nov

04, 2012

DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 124 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DP

EXCLUSIVITY CODE(S)

METHYLPHENIDATE HYDROCHLORIDE - METADATE CD N021259 002 6344215 Oct 27, 2020 METHYLPHENIDATE HYDROCHLORIDE - METADATE CD N021259 003 6344215 Oct 27, 2020 METHYLPHENIDATE HYDROCHLORIDE - METADATE CD N021259 004 6344215 Oct 27, 2020 METHYLPHENIDATE HYDROCHLORIDE - METHYLIN N021419 001 7691880 Oct 07, 2024 METHYLPHENIDATE HYDROCHLORIDE - METHYLIN N021419 002 7691880 Oct 07, 2024 METHYLPHENIDATE HYDROCHLORIDE - RITALIN N021284 001 5837284 Dec 04, 6228398 Nov 01, 6635284 Dec 04, 7431944 Dec 04, METHYLPHENIDATE HYDROCHLORIDE - RITALIN N021284 002 5837284 Dec 04, 6228398 Nov 01, 6635284 Dec 04, 7431944 Dec 04, METHYLPHENIDATE HYDROCHLORIDE - RITALIN N021284 003 5837284 Dec 04, 6228398 Nov 01, 6635284 Dec 04, 7431944 Dec 04, METHYLPHENIDATE HYDROCHLORIDE - RITALIN N021284 004 5837284 Dec 04, 6228398 Nov 01, 6635284 Dec 04, 7431944 Dec 04, LA 2015 2019 2015 2015 LA 2015 2019 2015 2015 LA 2015 2019 2015 2015 LA 2015 2019 2015 2015

DP

DP

DP

DP

DP DP DP DP

U-472 U-591

DP DP DP DP

U-472 U-591

DP DP DP DP

U-472 U-591

DP DP DP DP

U-472 U-591

METOCLOPRAMIDE HYDROCHLORIDE - METOZOLV ODT N022246 001 6413549 Jul 11, 2017 METOCLOPRAMIDE HYDROCHLORIDE - METOZOLV ODT N022246 002 6413549 Jul 11, 2017 METOCLOPRAMIDE HYDROCHLORIDE - REGLAN ODT Apr 09, 2018 N021793 001 6024981 Apr 09, 2018 6221392 METOCLOPRAMIDE HYDROCHLORIDE - REGLAN ODT N021793 002 6024981 Apr 09, 2018 6221392 Apr 09, 2018 METRONIDAZOLE - FLAGYL ER N020868 001 6103262 METRONIDAZOLE - METROGEL N021789 001 6881726 7348317

DP

DP

DP DP

DP DP

Aug

15, 2017

DP

U-137

Feb Feb

21, 2022 21, 2022

DP DP

U-743 U-743

METRONIDAZOLE - METROGEL-VAGINAL N020208 001 5536743 Jul METRONIDAZOLE - VANDAZOLE N021806 001 7456207

16, 2013

U-137

Sep

22, 2024

DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 125 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DS DS DS DS DS DP DP DP DP DP DP DP

EXCLUSIVITY CODE(S)

MICAFUNGIN SODIUM - MYCAMINE N021506 002 5376634 6107458 6107458 6265536 6265536 6774104 6774104 MICAFUNGIN SODIUM - MYCAMINE N021506 003 5376634 6107458 6107458 6265536 6265536 6774104 6774104 MICONAZOLE - ORAVIG N022404 001 6916485 7651698

Dec Mar Mar Sep Sep Jan Jan

27, 16, 16, 29, 29, 08, 08,

2011 2019 2019 2015 2015 2021 2021

U-650 U-845 U-650 U-845 U-845 U-650

Dec Mar Mar Sep Sep Jan Jan

27, 16, 16, 29, 29, 08, 08,

2011 2019 2019 2015 2015 2021 2021

DS DS DS DS DS

DP DP DP DP DP DP DP

U-845 U-650 U-845 U-650 U-845 U-650

Sep Jan

11, 2022 08, 2026

DP

U-1051 U-1051

NDF

Apr

16, 2013

MICONAZOLE NITRATE - MONISTAT 1 COMBINATION PACK N021308 001 5514698 Mar 21, 2014 6153635 Nov 28, 2020 MIGLUSTAT - ZAVESCA N021348 001 5472969 5525616

Y Y

May Jun

13, 2013 11, 2013

MILNACIPRAN HYDROCHLORIDE - SAVELLA N022256 001 6602911 Nov 05, 2021 6992110 Nov 05, 2021 7888342 Nov 05, 2021 7994220 Sep 19, 2029 MILNACIPRAN HYDROCHLORIDE - SAVELLA N022256 002 6602911 Nov 05, 2021 6992110 Nov 05, 2021 7888342 Nov 05, 2021 7994220 Sep 19, 2029 MILNACIPRAN HYDROCHLORIDE - SAVELLA N022256 003 6602911 Nov 05, 2021 6992110 Nov 05, 2021 7888342 Nov 05, 2021 7994220 Sep 19, 2029 MILNACIPRAN HYDROCHLORIDE - SAVELLA N022256 004 6602911 Nov 05, 2021 6992110 Nov 05, 2021 7888342 Nov 05, 2021 7994220 Sep 19, 2029 MINOCYCLINE HYDROCHLORIDE - SOLODYN N050808 001 5908838 Feb 19, 2018 7790705 Jun 24, 2025 7919483 Mar 07, 2027 MINOCYCLINE HYDROCHLORIDE - SOLODYN N050808 002 5908838 Feb 19, 2018 7541347 Apr 02, 2027 Apr 02, 2027 7544373 Jun 24, 2025 7790705 Mar 07, 2027 7919483 MINOCYCLINE HYDROCHLORIDE - SOLODYN N050808 003 5908838 Feb 19, 2018 7790705 Jun 24, 2025 7919483 Mar 07, 2027

U-882 U-882 U-882 U-819

NCE

Jan

14, 2014

U-882 U-882 U-882 U-819

NCE

Jan

14, 2014

U-882 U-882 U-882 U-819

NCE

Jan

14, 2014

U-882 U-882 U-882 U-819

NCE

Jan

14, 2014

U-917 U-1078 U-1078

U-917 U-917 DP U-1078 U-1078

U-917 U-1078 U-1078

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 126 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-917 U-1078 U-1078

EXCLUSIVITY CODE(S)

MINOCYCLINE HYDROCHLORIDE - SOLODYN N050808 004 5908838 Feb 19, 2018 7790705 Jun 24, 2025 7919483 Mar 07, 2027 MINOCYCLINE HYDROCHLORIDE - SOLODYN N050808 005 5908838 Feb 19, 2018 7790705 Jun 24, 2025 7919483 Mar 07, 2027 MINOCYCLINE HYDROCHLORIDE - SOLODYN N050808 006 5908838 Feb 19, 2018 7790705 Jun 24, 2025 7919483 Mar 07, 2027 MINOCYCLINE HYDROCHLORIDE - SOLODYN N050808 007 5908838 Feb 19, 2018 7790705 Jun 24, 2025 7919483 Mar 07, 2027 MINOCYCLINE HYDROCHLORIDE - SOLODYN N050808 008 5908838 Feb 19, 2018 7790705 Jun 24, 2025 7919483 Mar 07, 2027 MINOXIDIL - MEN'S ROGAINE N021812 001 6946120 MODAFINIL - PROVIGIL N020717 001 7297346 7297346*PED RE37516 RE37516*PED MODAFINIL - PROVIGIL N020717 002 7297346 7297346*PED RE37516 RE37516*PED

U-917 U-1078 U-1078

U-917 U-1078 U-1078

U-917 U-1078 U-1078

U-917 U-1078 U-1078

Apr

20, 2019

DP

U-702

Nov May Oct Apr

29, 29, 06, 06,

2023 2024 2014 2015

DP U-255

Nov May Oct Apr

29, 29, 06, 06,

2023 2024 2014 2015

DP U-255

MOMETASONE FUROATE - ASMANEX TWISTHALER N021067 001 5394868 Jun 25, 2012 5394868*PED Dec 25, 2012 5687710 Nov 18, 2014 5687710*PED May 18, 2015 5829434 Nov 03, 2015 5829434*PED May 03, 2016 5889015 Jan 27, 2014 5889015*PED Jul 27, 2014 6057307 Jan 27, 2014 6057307*PED Jul 27, 2014 6240918 Feb 20, 2017 6240918*PED Aug 20, 2017 6365581 Jan 27, 2014 6365581*PED Jul 27, 2014 6503537 Mar 17, 2018 6503537*PED Sep 17, 2018 6677322 Jan 27, 2014 6677322*PED Jul 27, 2014 6949532 Jan 27, 2014 6949532*PED Jul 27, 2014

DP DP DP U-645 DP DP U-645 DP U-645 U-645 U-645

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 127 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DP DP DP U-645 DP DP U-645 DP U-645 U-645 U-645

EXCLUSIVITY CODE(S)

MOMETASONE FUROATE - ASMANEX TWISTHALER Jun 25, 2012 N021067 002 5394868 Dec 25, 2012 5394868*PED Nov 18, 2014 5687710 May 18, 2015 5687710*PED Nov 03, 2015 5829434 May 03, 2016 5829434*PED Jan 27, 2014 5889015 Jul 27, 2014 5889015*PED Jan 27, 2014 6057307 Jul 27, 2014 6057307*PED Feb 20, 2017 6240918 Aug 20, 2017 6240918*PED Jan 27, 2014 6365581 Jul 27, 2014 6365581*PED Mar 17, 2018 6503537 Sep 17, 2018 6503537*PED Jan 27, 2014 6677322 Jul 27, 2014 6677322*PED Jan 27, 2014 6949532 Jul 27, 2014 6949532*PED MOMETASONE FUROATE MONOHYDRATE N020762 001 5837699 5837699*PED 6127353 6127353*PED 6723713 6723713*PED MONTELUKAST SODIUM - SINGULAIR N020829 002 5565473 5565473 5565473 5565473*PED MONTELUKAST SODIUM - SINGULAIR N020830 001 5565473 5565473 5565473 5565473*PED MONTELUKAST SODIUM - SINGULAIR N020830 002 5565473 5565473 5565473 5565473*PED MONTELUKAST SODIUM - SINGULAIR N021409 001 5565473 5565473 5565473*PED 8007830 MORPHINE SULFATE - AVINZA N021260 001 6066339 MORPHINE SULFATE - AVINZA N021260 002 6066339 MORPHINE SULFATE - AVINZA N021260 003 6066339 MORPHINE SULFATE - AVINZA N021260 004 6066339 MORPHINE SULFATE - AVINZA N021260 005 6066339 - NASONEX Jan 27, 2014 Jul 27, 2014 Oct 03, 2017 Apr 03, 2018 Jan 27, 2014 Jul 27, 2014

DP DS DP

U-625

I-626 M-99

May Jan

26, 2013 19, 2014

U-625

Feb Feb Feb Aug

03, 03, 03, 03,

2012 2012 2012 2012

DS DS DS

DP DP DP

U-807 U-228 U-675 U-228

Feb Feb Feb Aug

03, 03, 03, 03,

2012 2012 2012 2012

DS DS DS

DP DP DP

U-675 U-807 U-228 U-228

Feb Feb Feb Aug

03, 03, 03, 03,

2012 2012 2012 2012

DS DS DS

DP DP DP

U-228 U-675 U-807 U-228

Feb Feb Aug Oct

03, 03, 03, 24,

2012 2012 2012 2022

DS DS

DP DP DP

U-675 U-807

Nov

25, 2017

Nov

25, 2017

Nov

25, 2017

Nov

25, 2017

Nov

25, 2017

DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

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PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DP

EXCLUSIVITY CODE(S)

MORPHINE SULFATE - AVINZA N021260 006 6066339 MORPHINE SULFATE - DEPODUR N021671 001 5723147 5807572 5891467 5931809 5962016 5997899 6171613 6193998 6241999 MORPHINE SULFATE - DEPODUR N021671 002 5723147 5807572 5891467 5931809 5962016 5997899 6171613 6193998 6241999 MORPHINE SULFATE - DEPODUR N021671 003 5723147 5807572 5891467 5931809 5962016 5997899 6171613 6193998 6241999

Nov

25, 2017

Mar Sep Jan Jul Jan Sep Oct Sep Sep

03, 15, 31, 14, 31, 01, 01, 01, 01,

2015 2015 2017 2015 2017 2016 2016 2016 2016

DP DP DP DP DP DP DP DP

U-584

U-584 U-584

Mar Sep Jan Jul Jan Sep Oct Sep Sep

03, 15, 31, 14, 31, 01, 01, 01, 01,

2015 2015 2017 2015 2017 2016 2016 2016 2016

DP DP DP DP DP DP DP DP

U-584

U-584 U-584

Mar Sep Jan Jul Jan Sep Oct Sep Sep

03, 15, 31, 14, 31, 01, 01, 01, 01,

2015 2015 2017 2015 2017 2016 2016 2016 2016

DP DP DP DP DP DP DP DP

U-584

U-584 U-584

MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE - EMBEDA N022321 001 7682633 Jun 19, 2027 7682634 Jun 19, 2027 DP DP 7815934 Dec 12, 2027 MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE - EMBEDA N022321 002 7682633 Jun 19, 2027 7682634 Jun 19, 2027 DP DP 7815934 Dec 12, 2027 MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE - EMBEDA N022321 003 7682633 Jun 19, 2027 DP 7682634 Jun 19, 2027 DP 7815934 Dec 12, 2027 MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE - EMBEDA N022321 004 7682633 Jun 19, 2027 DP 7682634 Jun 19, 2027 DP 7815934 Dec 12, 2027 MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE - EMBEDA N022321 005 7682633 Jun 19, 2027 DP 7682634 Jun 19, 2027 DP 7815934 Dec 12, 2027 MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE - EMBEDA N022321 006 7682633 Jun 19, 2027 DP 7682634 Jun 19, 2027 DP 7815934 Dec 12, 2027

U-443

NC

Aug

13, 2012

U-443

NC

Aug

13, 2012

U-443

NC

Aug

13, 2012

U-443

NC

Aug

13, 2012

U-443

NC

Aug

13, 2012

U-443

NC

Aug

13, 2012

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 129 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DS DP U-298 U-298 U-298 U-298

EXCLUSIVITY CODE(S)

MOXIFLOXACIN HYDROCHLORIDE - AVELOX N021085 001 4990517 Dec 08, 2011 5607942 Mar 04, 2014 5849752 Dec 05, 2016 6610327 Oct 29, 2019

DP

MOXIFLOXACIN HYDROCHLORIDE - AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER DS DP U-298 N021277 001 4990517 Dec 08, 2011 U-298 5607942 Mar 04, 2014 U-298 5849752 Dec 05, 2016 DP U-298 6548079 Jul 25, 2020 MOXIFLOXACIN HYDROCHLORIDE - MOXEZA N022428 001 4990517 Dec 08, 2011 4990517*PED Jun 08, 2012 5607942 Mar 04, 2014 5607942*PED Sep 04, 2014 Sep 29, 2019 6716830 Mar 29, 2020 6716830*PED Sep 29, 2019 7671070 Mar 29, 2020 7671070*PED MOXIFLOXACIN HYDROCHLORIDE - VIGAMOX N021598 001 4990517 Dec 08, 2011 4990517*PED Jun 08, 2012 5607942 Mar 04, 2014 5607942*PED Sep 04, 2014 Sep 29, 2019 6716830 Mar 29, 2020 6716830*PED Sep 29, 2019 7671070 Mar 29, 2020 7671070*PED MUPIROCIN - CENTANY N050788 001 6013657 MUPIROCIN CALCIUM - BACTROBAN N050746 001 6025389

DS DS

DP DP DP DP

U-709 U-709

NP PED

Nov May

19, 2013 19, 2014

U-709

DS DS

DP DP DP

U-709 U-709

U-709

Jul

08, 2018

DP

Oct

20, 2014

DP

U-1122

MYCOPHENOLATE MOFETIL - CELLCEPT N050759 001 5688529 Nov

18, 2014

DP

MYCOPHENOLATE MOFETIL HYDROCHLORIDE - CELLCEPT N050758 001 5543408 Sep 15, 2013 MYCOPHENOLIC ACID - MYFORTIC N050791 001 6025391 6172107 6306900 MYCOPHENOLIC ACID - MYFORTIC N050791 002 6025391 6172107 6306900

DP

Apr Apr Apr

10, 2017 10, 2017 10, 2017

DP DP DP

U-908 U-908

Apr Apr Apr

10, 2017 10, 2017 10, 2017

DP DP DP

U-908 U-908

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 130 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DP DP DP DP DP DP DP DP DP DP DP DP DP DP DP DP DP DP U-1124 U-1123

EXCLUSIVITY CODE(S)
I-631

NALTREXONE - VIVITROL N021897 001 5792477 5916598 6194006 6264987 6331317 6379703 6379704 6395304 6403114 6495164 6495166 6534092 6537586 6596316 6667061 6713090 6939033 7799345 7919499 7919499 NAPROXEN SODIUM - NAPRELAN N020353 001 5637320 NAPROXEN SODIUM - NAPRELAN N020353 002 5637320 NAPROXEN SODIUM - NAPRELAN N020353 003 5637320

May May Dec May Nov Dec May Nov May May Nov May Nov Dec May Nov Nov May Oct Oct

02, 02, 30, 19, 12, 30, 19, 12, 02, 25, 12, 19, 12, 30, 25, 12, 12, 25, 15, 15,

2017 2017 2018 2020 2019 2018 2020 2019 2017 2020 2019 2020 2019 2018 2020 2019 2019 2020 2029 2029

Oct

12, 2013

Jun

10, 2014

Jun

10, 2014

Jun

10, 2014

NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE - TREXIMET Aug 14, 2017 N021926 001 6060499 Aug 14, 2017 6586458 Oct 02, 2025 7332183 Aug 14, 2017 8022095 NATEGLINIDE - STARLIX N021204 001 5463116 5488150 6559188 6641841 6844008 6878749 NATEGLINIDE - STARLIX N021204 002 5463116 5488150 6559188 6641841 6844008 6878749

DP DP DP DP

U-867 U-867 U-867 U-867

Oct Jan Sep Nov Nov Sep

21, 30, 15, 14, 14, 15,

2012 2013 2020 2017 2017 2020

DP DP DP DP

U-827 U-214 U-214

Oct Jan Sep Nov Nov Sep

21, 30, 15, 14, 14, 15,

2012 2013 2020 2017 2017 2020

DP DP DP DP

U-827 U-214 U-214

NEBIVOLOL HYDROCHLORIDE - BYSTOLIC N021742 002 5759580 Jun 6545040 Dec NEBIVOLOL HYDROCHLORIDE - BYSTOLIC N021742 003 5759580 Jun 6545040 Dec NEBIVOLOL HYDROCHLORIDE - BYSTOLIC N021742 004 5759580 Jun 6545040 Dec NEBIVOLOL HYDROCHLORIDE - BYSTOLIC N021742 005 5759580 Jun 6545040 Dec

02, 2015 17, 2021

DP DP

NCE U-3

Dec

17, 2012

02, 2015 17, 2021

DP DP

NCE U-3

Dec

17, 2012

02, 2015 17, 2021

DP DP

NCE U-3

Dec

17, 2012

02, 2015 17, 2021

DP DP

NCE U-3

Dec

17, 2012

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 131 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-304

EXCLUSIVITY CODE(S)

NEDOCROMIL SODIUM - ALOCRIL N021009 001 RE38628 NELARABINE - ARRANON N021877 001 5424295 5492897 5747472 5747472 5747472 5821236 NELFINAVIR MESYLATE - VIRACEPT N020778 001 5484926 5484926*PED 5952343 5952343*PED 6162812 6162812*PED NELFINAVIR MESYLATE - VIRACEPT N020779 001 5484926 5484926*PED 5952343 5952343*PED 6162812 6162812*PED NELFINAVIR MESYLATE - VIRACEPT N021503 001 5484926 5484926*PED 5952343 5952343*PED 6162812 6162812*PED NEPAFENAC - NEVANAC N021862 001 5475034 7834059 8071648

Aug

22, 2012

Jun Feb Feb Feb Feb Feb

13, 20, 20, 20, 20, 20,

2017 2013 2013 2013 2013 2013

DS

DP U-689 U-695 U-696 U-689 U-695

ODE

Oct

28, 2012

Oct Apr Oct Apr Oct Apr

07, 07, 07, 07, 07, 07,

2013 2014 2013 2014 2013 2014

U-257 U-257 U-248 U-248

Oct Apr Oct Apr Oct Apr

07, 07, 07, 07, 07, 07,

2013 2014 2013 2014 2013 2014

U-257 U-257 U-248 U-248

Oct Apr Oct Apr Oct Apr

07, 07, 07, 07, 07, 07,

2013
2014
2013 2014 2013 2014

U-257 U-257 U-248 U-248

Jun Jan Dec

06, 2014 31, 2027 02, 2025

U-100 U-1095 DP

NESIRITIDE RECOMBINANT - NATRECOR N020920 001 5114923 May NEVIRAPINE - VIRAMUNE N020636 001 5366972 5366972*PED NEVIRAPINE - VIRAMUNE N020933 001 5366972 5366972*PED NEVIRAPINE - VIRAMUNE XR N201152 001 5366972 5366972*PED NIACIN - NIASPAN N020381 001 6080428 6129930 6406715 6746691 6818229 7011848

19, 2014

DS

DP

U-855

Nov May

22, 2011 22, 2012

U-167

Nov May

22, 2011 22, 2012

Nov May

22, 2011 22, 2012

DS

DP

U-167

NDF

Mar

25, 2014

May Sep Sep Sep Feb Sep

27, 20, 20, 20, 15, 20,

2017 2013 2013 2013 2014 2013

U-331 U-354 U-450 U-586 DP U-712

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 132 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-1138 U-1139 U-1140 U-331 U-1141 U-1141 U-1140 U-1138 U-354 U-1139 U-450 U-1142 U-1145 U-768 U-1144 U-1143 U-1139 U-1140 U-1138 U-548 U-1146 U-586 U-1148 U-712 U-1147 U-1140 U-1141 U-1140 U-1138 U-1141 U-1139

EXCLUSIVITY CODE(S)

NIACIN - NIASPAN N020381 002 6080428 6080428 6080428 6080428 6080428 6129930 6129930 6129930 6129930 6129930 6406715 6469035 6469035 6469035 6469035 6469035 6676967 6676967 6676967 6676967 6676967 6746691 6818229 7011848 7011848 7011848 7011848 7011848 7998506 7998506 7998506 7998506 NIACIN - NIASPAN N020381 003 6080428 6080428 6080428 6080428 6080428 6129930 6129930 6129930 6129930 6129930 6406715 6469035 6469035 6469035 6469035 6469035 6676967 6676967 6676967 6676967 6676967 6676967 6746691 6818229 7011848 7011848 7011848 7011848 7011848 7998506 7998506 7998506 7998506

May May May May May Sep Sep Sep Sep Sep Sep Mar Mar Mar Mar Mar Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep

27, 27, 27, 27, 27, 20, 20, 20, 20, 20, 20, 15, 15, 15, 15, 15, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20,

2017 2017 2017 2017 2017 2013 2013 2013 2013 2013 2013 2018 2018 2018 2018 2018 2013 2013 2013 2013 2013 2013 2013 2013 2013 2013 2013 2013 2013 2013 2013 2013

DP DP DP DP DP DP

DP DP

May May May May May Sep Sep Sep Sep Sep Sep Mar Mar Mar Mar Mar Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep

27, 27, 27, 27, 27, 20, 20, 20, 20, 20, 20, 15, 15, 15, 15, 15, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20,

2017 2017 2017 2017 2017 2013 2013 2013 2013 2013 2013 2018 2018 2018 2018 2018 2013 2013 2013 2013 2013 2013 2013 2013 2013 2013 2013 2013 2013 2013 2013 2013 2013

DP DP DP DP DP DP

DP DP

U-1140 U-1138 U-331 U-1139 U-1141 U-354 U-1138 U-1141 U-1139 U-1140 U-450 U-1144 U-768 U-1145 U-1143 U-1142 U-1140 U-1141 U-1146 U-1138 U-548 U-1139 U-586 U-1148 U-712 U-1147 U-1140 U-1141 U-1138 U-1140 U-1139 U-1141

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 133 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-1140 U-331 U-1141 U-1139 U-1138 U-1139 U-354 U-1138 U-1141 U-1140 U-450 U-1143 U-768 U-1144 U-1145 U-1142 U-1140 U-548 U-1141 U-1138 U-1139 U-1146 U-586 U-1147 U-1148 U-1141 U-1140 U-712 U-1140 U-1139 U-1141 U-1138

EXCLUSIVITY CODE(S)

NIACIN - NIASPAN N020381 004 6080428 6080428 6080428 6080428 6080428 6129930 6129930 6129930 6129930 6129930 6406715 6469035 6469035 6469035 6469035 6469035 6676967 6676967 6676967 6676967 6676967 6676967 6746691 6818229 7011848 7011848 7011848 7011848 7011848 7998506 7998506 7998506 7998506

May May May May May Sep Sep Sep Sep Sep Sep Mar Mar Mar Mar Mar Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep

27, 27, 27, 27, 27, 20, 20, 20, 20, 20, 20, 15, 15, 15, 15, 15, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20,

2017 2017 2017 2017 2017 2013 2013 2013 2013 2013 2013 2018 2018 2018 2018 2018 2013 2013 2013 2013 2013 2013 2013 2013 2013 2013 2013 2013 2013 2013 2013 2013 2013

DP DP DP DP DP DP

DP DP

NIACIN - NIASPAN TITRATION STARTER PACK N020381 005 6080428 May 27, 2017 6129930 Sep 20, 2013 6406715 Sep 20, 2013 6746691 Sep 20, 2013 7011848 Sep 20, 2013 NIACIN; SIMVASTATIN - SIMCOR N022078 001 6080428 6080428 6080428 6129930 6129930 6129930 6406715 6469035 6469035 6469035 6676967 6676967 6676967 6746691 6818229 7011848 7011848 7011848 7998506 7998506

U-331 U-354 U-450 U-586 U-712

May May May Sep Sep Sep Sep Mar Mar Mar Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep

27, 27, 27, 20, 20, 20, 20, 15, 15, 15, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20,

2017 2017 2017 2013 2013 2013 2013 2018 2018 2018 2013 2013 2013 2013 2013 2013 2013 2013 2013 2013

DP DP DP DP

U-1134 U-1132 U-862 U-1132 U-862 U-1134 U-1149 U-863 U-1129 U-1132 U-1134 U-862

DP DP U-862 U-1150 U-1151 U-1151 U-1150

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 134 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-1134 U-1132 U-862 U-862 U-1134 U-1132 U-1129 U-863 U-1149 U-1132 U-1134 U-862 DP DP U-1150 U-862 U-1151 U-1150 U-1151

EXCLUSIVITY CODE(S)

NIACIN; SIMVASTATIN - SIMCOR N022078 002 6080428 6080428 6080428 6129930 6129930 6129930 6406715 6469035 6469035 6469035 6676967 6676967 6676967 6746691 6818229 7011848 7011848 7011848 7998506 7998506 NIACIN; SIMVASTATIN - SIMCOR N022078 003 6080428 6080428 6080428 6129930 6129930 6129930 6406715 6469035 6469035 6469035 6676967 6676967 6676967 6746691 6818229 7011848 7011848 7011848 7998506 7998506 NIACIN; SIMVASTATIN - SIMCOR N022078 004 6080428 6080428 6080428 6129930 6406715 6469035 6469035 6469035 6676967 6676967 6676967 6746691 6818229 7011848 7011848 7011848 7998506 7998506

May May May Sep Sep Sep Sep Mar Mar Mar Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep

27, 27, 27, 20, 20, 20, 20, 15, 15, 15, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20,

2017 2017 2017 2013 2013 2013 2013 2018 2018 2018 2013 2013 2013 2013 2013 2013 2013 2013 2013 2013

DP DP DP DP

May May May Sep Sep Sep Sep Mar Mar Mar Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep

27, 27, 27, 20, 20, 20, 20, 15, 15, 15, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20,

2017 2017 2017 2013 2013 2013 2013 2018 2018 2018 2013 2013 2013 2013 2013 2013 2013 2013 2013 2013

DP DP DP DP

U-862 U-1132 U-1134 U-1132 U-862 U-1134 U-1149 U-1129 U-863 U-1132 U-1134 U-862

DP DP U-862 U-1151 U-1150 U-1150 U-1151

May May May Sep Sep Mar Mar Mar Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep

27, 27, 27, 20, 20, 15, 15, 15, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20,

2017 2017 2017 2013 2013 2018 2018 2018 2013 2013 2013 2013 2013 2013 2013 2013 2013 2013

DP DP

U-1132 U-862 U-1134 U-862 U-863 U-1129 U-1149 U-1132 U-1134 U-862

DP DP U-862 U-1151 U-1150 U-1151 U-1150

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 135 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-862 U-1134 U-1132 U-862 U-1149 U-863 U-1129 U-1134 U-1132 U-862 DP DP U-1150 U-862 U-1151 U-1151 U-1150

EXCLUSIVITY CODE(S)

NIACIN; SIMVASTATIN - SIMCOR N022078 005 6080428 6080428 6080428 6129930 6406715 6469035 6469035 6469035 6676967 6676967 6676967 6746691 6818229 7011848 7011848 7011848 7998506 7998506

May May May Sep Sep Mar Mar Mar Sep Sep Sep Sep Sep Sep Sep Sep Sep Sep

27, 27, 27, 20, 20, 15, 15, 15, 20, 20, 20, 20, 20, 20, 20, 20, 20, 20,

2017 2017 2017 2013 2013 2018 2018 2018 2013 2013 2013 2013 2013 2013 2013 2013 2013 2013

DP DP

NICARDIPINE HYDROCHLORIDE - CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER N019734 004 7612102 Dec 26, 2027 DP U-1029 7659291 Apr 18, 2027 NICARDIPINE HYDROCHLORIDE - CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER N019734 003 7612102 Dec 26, 2027 DP U-1029 7659291 Apr 18, 2027 NICARDIPINE HYDROCHLORIDE - CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER N019734 002 7612102 Dec 26, 2027 DP U-1029 7659291 Apr 18, 2027 NICARDIPINE HYDROCHLORIDE - CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER N019734 005 7612102 Dec 26, 2027 DP U-1029 7659291 Apr 18, 2027 NICOTINE - NICODERM CQ N020165 004 5508038 NICOTINE - NICODERM CQ N020165 005 5508038 NICOTINE - NICODERM CQ N020165 006 5508038 NICOTINE - NICOTROL N020385 001 5656255

Apr

16, 2013

Apr

16, 2013

Apr

16, 2013

Aug

12, 2014

NILOTINIB HYDROCHLORIDE MONOHYDRATE - TASIGNA N022068 001 7169791 Jul 04, 2023

DS

DP

U-836

I-627 NCE ODE

Jun Oct Oct

17, 2013 29, 2012 29, 2014

NILOTINIB HYDROCHLORIDE MONOHYDRATE - TASIGNA N022068 002 7169791 Jul 04, 2023

DS

DP

U-836

I-627 NCE ODE

Jun Oct Oct

17, 2014 29, 2012 29, 2014

NISOLDIPINE - SULAR N020356 005 5422123 5626874 NISOLDIPINE - SULAR N020356 006 5422123 5626874 NISOLDIPINE - SULAR N020356 007 5422123 5626874

Jun Nov

06, 2012 30, 2014

DP DP

Jun Nov

06, 2012 30, 2014

DP DP

Jun Nov

06, 2012 30, 2014

DP DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 136 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DP DP

EXCLUSIVITY CODE(S)

NISOLDIPINE - SULAR N020356 008 5422123 5626874 NITAZOXANIDE - ALINIA N021497 001 5387598 5578621 5968961 6020353 NITAZOXANIDE - ALINIA N021498 001 5387598 5578621 5965590 5968961 6020353 6117894 NITISINONE - ORFADIN N021232 001 5550165 NITISINONE - ORFADIN N021232 002 5550165 NITISINONE - ORFADIN N021232 003 5550165 NITRIC OXIDE - INOMAX N020845 002 5485827 5485827*PED 5873359 5873359*PED NITRIC OXIDE - INOMAX N020845 003 5485827 5485827*PED 5873359 5873359*PED NITROGLYCERIN - NITROMIST N021780 001 5869082 NITROGLYCERIN - NITROSTAT N021134 001 6500456 NITROGLYCERIN - NITROSTAT N021134 002 6500456 NITROGLYCERIN - NITROSTAT N021134 003 6500456 NITROGLYCERIN - RECTIV N021359 001 7189761 NIZATIDINE - AXID N021494 001 6930119

Jun Nov

06, 2012 30, 2014

Feb Nov May Sep

07, 26, 07, 18,

2012 2013 2017 2014

DS

DP DP DP DP

U-524 U-525

Feb Sep Jul May Sep May

07, 08, 03, 07, 08, 07,

2012 2014 2017 2017 2014 2017

U-524 U-525 U-523

Aug

27, 2013

Aug

27, 2013

Aug

27, 2013

Jan Jul Jan Jul

23, 23, 23, 23,

2013 2013 2013 2013

U-297 U-297

Jan Jul Jan Jul

23, 23, 23, 23,

2013 2013 2013 2013

U-297 U-297

Apr

16, 2016

DP

Sep

16, 2018

Sep

16, 2018

Sep

16, 2018

May

27, 2014

DP

U-1198

NP

Jun

21, 2014

Jul

17, 2022

DP

OCTREOTIDE ACETATE - SANDOSTATIN May N019667 001 5753618 Nov 5753618*PED OCTREOTIDE ACETATE - SANDOSTATIN May N019667 002 5753618 Nov 5753618*PED OCTREOTIDE ACETATE - SANDOSTATIN May N019667 003 5753618 Nov 5753618*PED

19, 2015 19, 2015

19, 2015 19, 2015

19, 2015 19, 2015

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 137 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)

OCTREOTIDE ACETATE - SANDOSTATIN N019667 004 5753618 May Nov 5753618*PED OCTREOTIDE ACETATE - SANDOSTATIN May N019667 005 5753618 Nov 5753618*PED

19, 2015 19, 2015

19, 2015 19, 2015

OCTREOTIDE ACETATE - SANDOSTATIN LAR Jul 23, N021008 001 5538739 Jan 23, 5538739*PED Jun 17, 5639480 Dec 17, 5639480*PED Nov 18, 5688530 May 18, 5688530*PED Jul 13, 5922338 Jan 13, 5922338*PED Jul 13, 5922682 Jan 13, 5922682*PED OCTREOTIDE ACETATE - SANDOSTATIN LAR N021008 002 5538739 Jul 23, 5538739*PED Jan 23, 5639480 Jun 17, 5639480*PED Dec 17, 5688530 Nov 18, 5688530*PED May 18, Jul 13, 5922338 Jan 13, 5922338*PED Jul 13, 5922682 Jan 13, 5922682*PED OCTREOTIDE ACETATE - SANDOSTATIN LAR N021008 003 5538739 Jul 23, 5538739*PED Jan 23, 5639480 Jun 17, 5639480*PED Dec 17, 5688530 Nov 18, 5688530*PED May 18, Jul 13, 5922338 Jan 13, 5922338*PED Jul 13, 5922682 Jan 13, 5922682*PED OFLOXACIN - FLOXIN OTIC N020799 001 5401741 OLANZAPINE - OLANZAPINE A076000 001 OLANZAPINE - OLANZAPINE A076000 002 OLANZAPINE - OLANZAPINE A076000 003 OLANZAPINE - OLANZAPINE A076000 004 OLANZAPINE - OLANZAPINE A076000 005 OLANZAPINE - OLANZAPINE A076133 002

2013 2014 2014 2014 2014 2015 2016 2017 2016 2017

DP DP U-268 DP DP

2013 2014 2014 2014 2014 2015 2016 2017 2016 2017

DP U-268 DP DP

2013 2014 2014 2014 2014 2015 2016 2017 2016 2017

DP U-268 DP DP

Mar

27, 2012

U-407

PC

Apr

21, 2012

PC

Apr

21, 2012

PC

Apr

21, 2012

PC

Apr

21, 2012

PC

Apr

21, 2012

PC

Apr

21, 2012

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 138 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)
I-591 NPP NPP PED PED

OLANZAPINE - ZYPREXA N020592 001 5229382*PED 5605897 5605897*PED 5627178*PED 5736541 5736541*PED 5817655*PED 5817656*PED 5817657*PED 5919485 5919485*PED 6251895 6251895*PED 6960577 OLANZAPINE - ZYPREXA N020592 002 5229382*PED 5605897 5605897*PED 5627178*PED 5736541 5736541*PED 5817655*PED 5817656*PED 5817657*PED 5919485 5919485*PED 6251895 6251895*PED 6960577 OLANZAPINE - ZYPREXA N020592 003 5229382*PED 5605897 5605897*PED 5627178*PED 5736541 5736541*PED 5817655*PED 5817656*PED 5817657*PED 5919485 5919485*PED 6251895 6251895*PED 6960577 OLANZAPINE - ZYPREXA N020592 004 5229382*PED 5605897 5605897*PED 5627178*PED 5736541 5736541*PED 5817655*PED 5817656*PED 5817657*PED 5919485 5919485*PED 6251895 6251895*PED 6960577

Oct Feb Aug Oct Mar Sep Oct Oct Oct Mar Sep Sep Mar Nov

23, 25, 25, 23, 24, 24, 23, 23, 23, 24, 24, 23, 23, 01,

2011 2014 2014 2011 2015 2015 2011 2011 2011 2015 2015 2017 2018 2017

U-176

U-307

Mar Dec Dec Jun Jun

19, 04, 04, 04, 04,

2012 2012 2012 2013 2013

U-308

U-963

Oct Feb Aug Oct Mar Sep Oct Oct Oct Mar Sep Sep Mar Nov

23, 25, 25, 23, 24, 24, 23, 23, 23, 24, 24, 23, 23, 01,

2011 2014 2014 2011 2015 2015 2011 2011 2011 2015 2015 2017 2018 2017

U-176

U-307

I-591 NPP NPP PED PED

Mar Dec Dec Jun Jun

19, 04, 04, 04, 04,

2012 2012 2012 2013 2013

U-308

U-963

Oct Feb Aug Oct Mar Sep Oct Oct Oct Mar Sep Sep Mar Nov

23, 25, 25, 23, 24, 24, 23, 23, 23, 24, 24, 23, 23, 01,

2011 2014 2014 2011 2015 2015 2011 2011 2011 2015 2015 2017 2018 2017

U-176

U-307

I-591 NPP NPP PED PED

Mar Dec Dec Jun Jun

19, 04, 04, 04, 04,

2012 2012 2012 2013 2013

U-308

U-963

Oct Feb Aug Oct Mar Sep Oct Oct Oct Mar Sep Sep Mar Nov

23, 25, 25, 23, 24, 24, 23, 23, 23, 24, 24, 23, 23, 01,

2011 2014 2014 2011 2015 2015 2011 2011 2011 2015 2015 2017 2018 2017

U-176

U-307

I-591 NPP NPP PED PED

Mar Dec Dec Jun Jun

19, 04, 04, 04, 04,

2012 2012 2012 2013 2013

U-308

U-963

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

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PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)
I-591 NPP NPP PED PED

OLANZAPINE - ZYPREXA N020592 005 5229382*PED 5605897 5605897*PED 5627178*PED 5736541 5736541*PED 5817655*PED 5817656*PED 5817657*PED 5919485 5919485*PED 6251895 6251895*PED 6960577 OLANZAPINE - ZYPREXA N020592 006 5229382*PED 5605897 5605897*PED 5627178*PED 5736541 5736541*PED 5817655*PED 5817656*PED 5817657*PED 5919485 5919485*PED 6251895 6251895*PED 6960577 OLANZAPINE - ZYPREXA N021253 001 5229382*PED OLANZAPINE - ZYPREXA ZYDIS N021086 001 5229382*PED 6960577

Oct Feb Aug Oct Mar Sep Oct Oct Oct Mar Sep Sep Mar Nov

23, 25, 25, 23, 24, 24, 23, 23, 23, 24, 24, 23, 23, 01,

2011 2014 2014 2011 2015 2015 2011 2011 2011 2015 2015 2017 2018 2017

U-176

U-307

Mar Dec Dec Jun Jun

19, 04, 04, 04, 04,

2012 2012 2012 2013 2013

U-308

U-963

Oct Feb Aug Oct Mar Sep Oct Oct Oct Mar Sep Sep Mar Nov

23, 25, 25, 23, 24, 24, 23, 23, 23, 24, 24, 23, 23, 01,

2011 2014 2014 2011 2015 2015 2011 2011 2011 2015 2015 2017 2018 2017

U-176

U-307

I-591 NPP NPP PED PED

Mar Dec Dec Jun Jun

19, 04, 04, 04, 04,

2012 2012 2012 2013 2013

U-308

U-963

Oct

23, 2011

Oct Nov

23, 2011 01, 2017

U-964

I-591 NPP NPP PED PED

Mar Dec Dec Jun Jun

19, 04, 04, 04, 04,

2012 2012 2012 2013 2013

OLANZAPINE - ZYPREXA ZYDIS N021086 002 5229382*PED 6960577

Oct Nov

23, 2011 01, 2017

U-964

I-591 NPP NPP PED PED

Mar Dec Dec Jun Jun

19, 04, 04, 04, 04,

2012 2012 2012 2013 2013

OLANZAPINE - ZYPREXA ZYDIS N021086 003 5229382*PED 6960577

Oct Nov

23, 2011 01, 2017

U-964

I-591 NPP NPP PED PED

Mar Dec Dec Jun Jun

19, 04, 04, 04, 04,

2012 2012 2012 2013 2013

OLANZAPINE - ZYPREXA ZYDIS N021086 004 5229382*PED 6960577

Oct Nov

23, 2011 01, 2017

U-964

I-591 NPP NPP PED PED

Mar Dec Dec Jun Jun

19, 04, 04, 04, 04,

2012 2012 2012 2013 2013

OLANZAPINE PAMOATE - ZYPREXA RELPREVV N022173 001 5229382*PED Oct 23, 2011 6169084 Sep 30, 2018

NP DS DP U-1026

Dec

11, 2012

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 140 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)
NP

OLANZAPINE PAMOATE - ZYPREXA RELPREVV Oct 23, 2011 N022173 002 5229382*PED Sep 30, 2018 6169084 OLANZAPINE PAMOATE - ZYPREXA RELPREVV Oct 23, 2011 N022173 003 5229382*PED Sep 30, 2018 6169084 OLMESARTAN MEDOXOMIL - BENICAR N021286 001 5616599 5616599*PED 6878703 6878703*PED OLMESARTAN MEDOXOMIL - BENICAR N021286 003 5616599 5616599*PED 6878703 6878703*PED OLMESARTAN MEDOXOMIL - BENICAR N021286 004 5616599 5616599*PED 6878703 6878703*PED

Dec

11, 2012

DS

DP

U-1026

NP DS DP U-1026

Dec

11, 2012

Apr Oct Nov May

25, 25, 19, 19,

2016 2016 2021 2022

DS

DP

U-500 U-3 Y

NPP PED

Feb Aug

04, 2013 04, 2013

Apr Oct Nov May

25, 25, 19, 19,

2016 2016 2021 2022

DS

DP

U-500 U-3 Y

NPP PED

Feb Aug

04, 2013 04, 2013

Apr Oct Nov May

25, 25, 19, 19,

2016 2016 2021 2022

DS

DP

U-500 U-3 Y

NPP PED

Feb Aug

04, 2013 04, 2013

OLOPATADINE HYDROCHLORIDE - PATADAY N021545 001 5641805 Jun 06, 2015 5641805*PED Dec 06, 2015 6995186 Nov 12, 2023 6995186*PED May 12, 2024 7402609 Jun 19, 2022 7402609*PED Dec 19, 2022 OLOPATADINE HYDROCHLORIDE - PATANASE Feb 02, 2023 N021861 001 7977376 Aug 02, 2023 7977376*PED

U-765 DP DP U-765

DP DP

NPP PED PED U-184

Dec Jun Oct

01, 2012 01, 2013 15, 2011

OLOPATADINE HYDROCHLORIDE - PATANOL N020688 001 5641805 Jun 06, 2015 5641805*PED Dec 06, 2015 OMEGA-3-ACID ETHYL ESTERS - LOVAZA N021654 001 5502077 Mar 5656667 Apr Jan 7732488 OMEPRAZOLE - PRILOSEC N019810 001 6147103 6147103*PED 6150380 6150380*PED 6166213 6166213*PED 6191148 6191148*PED OMEPRAZOLE - PRILOSEC N019810 002 6147103 6147103*PED 6150380 6150380*PED 6166213 6166213*PED 6191148 6191148*PED

26, 2013 10, 2017 30, 2025

DS DS DS

DP DP

U-822 U-822

M-87

Sep

16, 2012

Oct Apr Nov May Oct Apr Oct Apr

09, 09, 10, 10, 09, 09, 09, 09,

2018 2019 2018 2019 2018 2019 2018 2019

Oct Apr Nov May Oct Apr Oct Apr

09, 09, 10, 10, 09, 09, 09, 09,

2018 2019 2018 2019 2018 2019 2018 2019

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 141 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)

OMEPRAZOLE - PRILOSEC N019810 003 6147103 6147103*PED 6150380 6150380*PED 6166213 6166213*PED 6191148 6191148*PED

Oct Apr Nov May Oct Apr Oct Apr

09, 09, 10, 10, 09, 09, 09, 09,

2018 2019 2018 2019 2018 2019 2018 2019

OMEPRAZOLE MAGNESIUM - PRILOSEC Nov N022056 001 5690960 May 5900424 Nov 6428810 OMEPRAZOLE MAGNESIUM - PRILOSEC N022056 002 5690960 Nov 5900424 May Nov 6428810 OMEPRAZOLE MAGNESIUM - PRILOSEC OTC N021229 001 5690960 Nov 5753265 Jun 5817338 Oct 5900424 May Nov 6403616 Nov 6428810 OMEPRAZOLE; SODIUM BICARBONATE N021636 001 5840737 6489346 6645988 6699885 6780882 7399772 OMEPRAZOLE; SODIUM BICARBONATE N021636 002 5840737 5840737 6489346 6489346 6645988 6699885 6699885 6780882 7399772 7399772 OMEPRAZOLE; SODIUM BICARBONATE N021849 001 6489346 6645988 6699885 7399772 OMEPRAZOLE; SODIUM BICARBONATE N021849 002 6489346 6645988 6699885 7399772 OMEPRAZOLE; SODIUM BICARBONATE N022281 001 6489346 6645988 6699885 7399772

25, 2014 04, 2016 03, 2019

DP DS DP

U-864 U-864 U-864

PED

Sep

20, 2011

25, 2014 04, 2016 03, 2019

DP DS DP

U-864 U-864 U-864

PED

Sep

20, 2011

25, 07, 06, 04, 15, 03,

2014 2015 2015 2016 2019 2019

- ZEGERID Jul 16, 2016 Jul 16, 2016 Jul 16, 2016 Jul 16, 2016 Jul 16, 2016 Jul 16, 2016 - ZEGERID Jul 16, 2016 Jul 16, 2016 Jul 16, 2016 Jul 16, 2016 Jul 16, 2016 Jul 16, 2016 Jul 16, 2016 Jul 16, 2016 Jul 16, 2016 Jul 16, 2016 - ZEGERID Jul 16, 2016 Jul 16, 2016 Jul 16, 2016 Jul 16, 2016 - ZEGERID Jul 16, 2016 Jul 16, 2016 Jul 16, 2016 Jul 16, 2016 - ZEGERID OTC Jul 15, 2016 Jul 15, 2016 Jul 15, 2016 Jul 15, 2016

DS DS DS

DP DP DP

U-588 U-588 U-588 U-588

DS DS DS

DP DP DP

U-624 U-623 U-624 U-623 U-623 U-624

DS

DP U-623 U-624

DS DS

DP DP

U-588 U-588 U-588

DS DS

DP DP

U-623 U-623 U-623

DP DP DP

U-1025

U-1025

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 142 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)

ONDANSETRON - ZOFRAN ODT N020781 001 5955488 5955488*PED 6063802 6063802*PED ONDANSETRON - ZOFRAN ODT N020781 002 5955488 5955488*PED 6063802 6063802*PED

Nov May Nov May

14, 14, 14, 14,

2015 2016 2015 2016

Nov May Nov May

14, 14, 14, 14,

2015 2016 2015 2016

ONDANSETRON HYDROCHLORIDE - ZOFRAN N020103 001 5344658 Sep 5344658*PED Mar ONDANSETRON HYDROCHLORIDE - ZOFRAN N020103 002 5344658 Sep 5344658*PED Mar ONDANSETRON HYDROCHLORIDE - ZOFRAN N020103 003 5344658 Sep 5344658*PED Mar ONDANSETRON HYDROCHLORIDE - ZOFRAN Nov N020605 001 5854270 May 5854270*PED ORLISTAT - ALLI N021887 001 6004996 ORLISTAT - XENICAL N020766 001 6004996 6004996*PED

06, 2011 06, 2012

06, 2011 06, 2012

06, 2011 06, 2012

20, 2015 20, 2016

DP

U-44

Jan

06, 2018

DP

Jan Jul

06, 2018 06, 2018

OSELTAMIVIR PHOSPHATE - TAMIFLU N021087 001 5763483 Dec 5763483*PED Jun 5866601 Feb 5866601*PED Aug 5952375 Feb 5952375*PED Aug OSELTAMIVIR PHOSPHATE - TAMIFLU N021087 002 5763483 Dec 5763483*PED Jun 5866601 Feb 5866601*PED Aug 5952375 Feb 5952375*PED Aug OSELTAMIVIR PHOSPHATE - TAMIFLU N021087 003 5763483 Dec 5763483*PED Jun 5866601 Feb 5866601*PED Aug 5952375 Feb 5952375*PED Aug OSELTAMIVIR PHOSPHATE - TAMIFLU N021246 001 5763483 Dec 5763483 Dec 5763483*PED Jun 5866601 Feb 5866601*PED Aug Feb 5952375 Aug 5952375*PED

27, 27, 02, 02, 27, 27,

2016 2017 2016 2016 2015 2015

DS DS DS DP DP

U-1113

M-90

Feb

22, 2013

27, 27, 02, 02, 27, 27,

2016 2017 2016 2016 2015 2015

DS DS DS DP DP

U-1113

M-90

Feb

22, 2013

27, 27, 02, 02, 27, 27,

2016 2017 2016 2016 2015 2015

DS DS DS DP DP

U-1113

27, 27, 27, 02, 02, 27, 27,

2016 2016 2017 2016 2016 2015 2015

DS DS DS DS DP DP

U-376 U-1113

M-90

Feb

22, 2013

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 143 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DS DS DS DP DP DP U-1113

EXCLUSIVITY CODE(S)

OSELTAMIVIR PHOSPHATE - TAMIFLU Dec N021246 002 5763483 Jun 5763483*PED Feb 5866601 Aug 5866601*PED Feb 5952375 Aug 5952375*PED OXALIPLATIN - ELOXATIN N021492 001 5290961 5290961*PED 5338874 5338874*PED 5420319 5420319*PED OXALIPLATIN - ELOXATIN N021492 002 5290961 5290961*PED 5338874 5338874*PED 5420319 5420319*PED OXALIPLATIN - ELOXATIN N021759 001 5290961 5290961*PED 5338874 5338874*PED 5420319 5420319*PED 5716988 5716988*PED OXALIPLATIN - ELOXATIN N021759 002 5290961 5290961*PED 5338874 5338874*PED 5420319 5420319*PED 5716988 5716988*PED OXALIPLATIN - ELOXATIN N021759 003 5290961 5290961*PED 5338874 5338874*PED 5420319 5420319*PED 5716988 5716988*PED OXANDROLONE - OXANDRIN N013718 001 5872147 6090799 6576659 6670351 6828313 OXANDROLONE - OXANDRIN N013718 002 5872147 6090799 6576659 6670351 6828313

27, 27, 02, 02, 27, 27,

2016 2017 2016 2016 2015 2015

Jan Jul Apr Oct Aug Feb

12, 12, 07, 07, 09, 09,

2013 2013 2013 2013 2016 2017

DS DS DS

Jan Jul Apr Oct Aug Feb

12, 12, 07, 07, 09, 09,

2013 2013 2013 2013 2016 2017

DS DS DS

Jan Jul Apr Oct Aug Feb Aug Feb

12, 12, 07, 07, 09, 09, 07, 07,

2013 2013 2013 2013 2016 2017 2015 2016

DS DS DS DP

Jan Jul Apr Oct Aug Feb Aug Feb

12, 12, 07, 07, 09, 09, 07, 07,

2013 2013 2013 2013 2016 2017 2015 2016

DS DS DS DP

Jan Jul Apr Oct Aug Feb Aug Feb

12, 12, 07, 07, 09, 09, 07, 07,

2013 2013 2013 2013 2016 2017 2015 2016

DS DS DS DP

Dec Jul Dec Oct Dec

05, 18, 05, 20, 05,

2017 2017 2017 2012 2017

U-585 U-585 U-585 U-585 U-585

Dec Jul Dec Oct Dec

05, 18, 05, 20, 05,

2017 2017 2017 2012 2017

U-585 U-585 U-585 U-585 U-585

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 144 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-724

EXCLUSIVITY CODE(S)

OXCARBAZEPINE - TRILEPTAL N021014 001 7037525 7037525*PED OXCARBAZEPINE - TRILEPTAL N021014 002 7037525 7037525*PED OXCARBAZEPINE - TRILEPTAL N021014 003 7037525 7037525*PED OXCARBAZEPINE - TRILEPTAL N021285 001 7037525 7037525*PED OXYBUTYNIN - ANTUROL N202513 001 OXYBUTYNIN - OXYTROL N021351 002 5601839 5834010 6743441 7081249 7081250 7081251 7081252 7179483 OXYBUTYNIN CHLORIDE - DITROPAN N020897 001 5674895 5674895*PED 5840754 5840754*PED 5912268 5912268*PED 6262115 6262115*PED OXYBUTYNIN CHLORIDE - DITROPAN N020897 002 5674895 5674895*PED 5840754 5840754*PED 5912268 5912268*PED 6262115 6262115*PED OXYBUTYNIN CHLORIDE - DITROPAN N020897 003 5674895 5674895*PED 5840754 5840754*PED 5912268 5912268*PED 6262115 6262115*PED

Feb Aug

12, 2018 12, 2018

Feb Aug

12, 2018 12, 2018

U-724

Feb Aug

12, 2018 12, 2018

U-724

Feb Aug

12, 2018 12, 2018

U-724

NP Apr Apr Apr Apr Apr Apr Apr Apr XL May Nov May Nov May Nov May Nov XL May Nov May Nov May Nov May Nov XL May Nov May Nov May Nov May Nov 26, 26, 26, 26, 26, 26, 26, 26, 2015 2015 2020 2020 2020 2020 2020 2020

Dec

07, 2014

DS

DP DP DP DP DP DP

U-318 U-318 U-318 U-318 U-318 U-318

22, 22, 22, 22, 22, 22, 22, 22,

2015 2015 2015 2015 2015 2015 2015 2015

U-393 U-393

22, 22, 22, 22, 22, 22, 22, 22,

2015 2015 2015 2015 2015 2015 2015 2015

U-393 U-393

22, 22, 22, 22, 22, 22, 22, 22,

2015 2015 2015 2015 2015 2015 2015 2015

U-393 U-393

OXYBUTYNIN CHLORIDE - GELNIQUE N022204 001 7029694 Apr 7179483 Apr OXYCODONE HYDROCHLORIDE - OXECTA N202080 001 7201920 Mar 7510726 Nov 7981439 Nov

26, 2020 26, 2020

DP

U-318 U-318

NDF

Jan

27, 2012

16, 2025 26, 2023 26, 2023

DP DP DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 145 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DP DP DP

EXCLUSIVITY CODE(S)

OXYCODONE HYDROCHLORIDE - OXECTA N202080 002 7201920 Mar 7510726 Nov 7981439 Nov

16, 2025 26, 2023 26, 2023

OXYCODONE HYDROCHLORIDE - OXYCONTIN N020553 001 5508042 Apr 16, 2013 7674799 Mar 30, 2025 7674800 Mar 30, 2025 7683072 Mar 30, 2025 OXYCODONE HYDROCHLORIDE - OXYCONTIN Apr 16, 2013 N020553 002 5508042 Mar 30, 2025 7674799 Mar 30, 2025 7674800 Mar 30, 2025 7683072 OXYCODONE HYDROCHLORIDE - OXYCONTIN N020553 003 5508042 Apr 16, 2013 7674799 Mar 30, 2025 7674800 Mar 30, 2025 7683072 Mar 30, 2025 OXYCODONE HYDROCHLORIDE - OXYCONTIN N020553 004 5508042 Apr 16, 2013 7674799 Mar 30, 2025 7674800 Mar 30, 2025 7683072 Mar 30, 2025 OXYCODONE HYDROCHLORIDE - OXYCONTIN Apr 16, 2013 N020553 005 5508042 Mar 30, 2025 7674799 Mar 30, 2025 7674800 Mar 30, 2025 7683072 OXYCODONE HYDROCHLORIDE - OXYCONTIN N020553 006 5508042 Apr 16, 2013 7674799 Mar 30, 2025 7674800 Mar 30, 2025 7683072 Mar 30, 2025 OXYCODONE HYDROCHLORIDE - OXYCONTIN Apr 16, 2013 N020553 007 5508042 Mar 30, 2025 7674799 Mar 30, 2025 7674800 Mar 30, 2025 7683072 OXYCODONE HYDROCHLORIDE - OXYCONTIN N020553 008 5508042 Apr 16, 2013 7674799 Mar 30, 2025 7674800 Mar 30, 2025 7683072 Mar 30, 2025 OXYCODONE HYDROCHLORIDE - OXYCONTIN N022272 001 5508042 Apr 16, 2013 6488963 Jun 24, 2017 7674799 Mar 30, 2025 7674800 Mar 30, 2025 7683072 Mar 30, 2025 7776314 Apr 19, 2025 OXYCODONE HYDROCHLORIDE - OXYCONTIN N022272 002 5508042 Apr 16, 2013 6488963 Jun 24, 2017 7674799 Mar 30, 2025 7674800 Mar 30, 2025 7683072 Mar 30, 2025 7776314 Apr 19, 2025

U-443 DP DS DS

U-443 DP DS DS

U-443 DP DS DS

U-443 DP DS DS

U-443 DP DS DS

U-443 DP DS DS

U-443 DP DS DS

U-443 DP DS DS

U-443 DP DP DS DS DP

U-443 DP DP DS DS DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 146 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-443 DP DP DS DS DP

EXCLUSIVITY CODE(S)

OXYCODONE HYDROCHLORIDE - OXYCONTIN Apr 16, 2013 N022272 003 5508042 Jun 24, 2017 6488963 Mar 30, 2025 7674799 Mar 30, 2025 7674800 Mar 30, 2025 7683072 Apr 19, 2025 7776314 OXYCODONE HYDROCHLORIDE - OXYCONTIN N022272 004 5508042 Apr 16, 2013 6488963 Jun 24, 2017 7674799 Mar 30, 2025 7674800 Mar 30, 2025 7683072 Mar 30, 2025 7776314 Apr 19, 2025 OXYCODONE HYDROCHLORIDE - OXYCONTIN Apr 16, 2013 N022272 005 5508042 Jun 24, 2017 6488963 Mar 30, 2025 7674799 Mar 30, 2025 7674800 Mar 30, 2025 7683072 Apr 19, 2025 7776314 OXYCODONE HYDROCHLORIDE - OXYCONTIN N022272 006 5508042 Apr 16, 2013 6488963 Jun 24, 2017 7674799 Mar 30, 2025 7674800 Mar 30, 2025 7683072 Mar 30, 2025 7776314 Apr 19, 2025 OXYCODONE HYDROCHLORIDE - OXYCONTIN Apr 16, 2013 N022272 007 5508042 Jun 24, 2017 6488963 Mar 30, 2025 7674799 Mar 30, 2025 7674800 Mar 30, 2025 7683072 Apr 19, 2025 7776314 OXYMORPHONE HYDROCHLORIDE - OPANA ER N021610 001 5662933 Sep 09, 2013 5958456 Sep 09, 2013 Feb 04, 2023 7276250 OXYMORPHONE HYDROCHLORIDE - OPANA ER Sep 09, 2013 N021610 002 5662933 Sep 09, 2013 5958456 7276250 Feb 04, 2023 OXYMORPHONE HYDROCHLORIDE - OPANA ER Sep 09, 2013 N021610 003 5662933 Sep 09, 2013 5958456 7276250 Feb 04, 2023 OXYMORPHONE HYDROCHLORIDE - OPANA ER Sep 09, 2013 N021610 004 5662933 Sep 09, 2013 5958456 7276250 Feb 04, 2023 OXYMORPHONE HYDROCHLORIDE - OPANA ER Sep 09, 2013 N021610 005 5662933 Sep 09, 2013 5958456 Feb 04, 2023 7276250 OXYMORPHONE HYDROCHLORIDE - OPANA ER N021610 006 5662933 Sep 09, 2013 5958456 Sep 09, 2013 Feb 04, 2023 7276250

U-443 DP DP DS DS DP

U-443 DP DP DS DS DP

U-443 DP DP DS DS DP

U-443 DP DP DS DS DP

DP DP DP

U-826

DP DP DP

U-826

DP DP DP

U-826

DP DP DP

U-826

DP DP DP

U-826

DP DP DP

U-826

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 147 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DP DP DP

EXCLUSIVITY CODE(S)

OXYMORPHONE HYDROCHLORIDE - OPANA ER Sep 09, 2013 N021610 007 5662933 Sep 09, 2013 5958456 Feb 04, 2023 7276250 OXYMORPHONE HYDROCHLORIDE - OPANA ER N201655 001 8075872 Nov 20, 2023 OXYMORPHONE HYDROCHLORIDE - OPANA ER N201655 002 8075872 Nov 20, 2023 OXYMORPHONE HYDROCHLORIDE - OPANA ER N201655 003 8075872 Nov 20, 2023 OXYMORPHONE HYDROCHLORIDE - OPANA ER N201655 004 8075872 Nov 20, 2023 OXYMORPHONE HYDROCHLORIDE - OPANA ER N201655 005 8075872 Nov 20, 2023 OXYMORPHONE HYDROCHLORIDE - OPANA ER N201655 006 8075872 Nov 20, 2023 OXYMORPHONE HYDROCHLORIDE - OPANA ER N201655 007 8075872 Nov 20, 2023 PACLITAXEL - ABRAXANE N021660 001 5439686 5498421 6096331 6506405 6537579 6749868 6753006 7820788 7923536 RE41884 PALIPERIDONE - INVEGA N021999 001

U-826

DP

DP

DP

DP

DP

DP

DP

Feb Mar Feb Feb Feb Feb Feb Mar Dec Aug

22, 12, 22, 22, 22, 22, 22, 03, 09, 14,

2013 2013 2013 2013 2013 2013 2013 2024 2023 2016

DP DP DP DP DP DP DP

U-634 U-633 U-633 U-632

U-1092 U-1117 U-1117

I-605 I-606 NPP NCE PED PED PED PED

Jul Jul Apr Dec Oct Jun Jan Jan

31, 31, 06, 19, 06, 19, 31, 31,

2012 2012 2014 2011 2014 2012 2013 2013

PALIPERIDONE - INVEGA N021999 002

I-605 I-606 NPP NCE PED PED PED PED

Jul Jul Apr Dec Oct Jun Jan Jan

31, 31, 06, 19, 06, 19, 31, 31,

2012 2012 2014 2011 2014 2012 2013 2013

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 148 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)
I-605 I-606 NPP NCE PED PED PED PED

PALIPERIDONE - INVEGA N021999 003

Jul Jul Apr Dec Oct Jun Jan Jan

31, 31, 06, 19, 06, 19, 31, 31,

2012 2012 2014 2011 2014 2012 2013 2013

PALIPERIDONE - INVEGA N021999 004

NPP NCE PED PED

Apr Dec Oct Jun

06, 19, 06, 19,

2014 2011 2014 2012

PALIPERIDONE - INVEGA N021999 006

I-605 I-606 NPP NCE PED PED PED PED DS DP DP DP DP U-543 U-543 U-543

Jul Jul Apr Dec Oct Jun Jan Jan

31, 31, 06, 19, 06, 19, 31, 31,

2012 2012 2014 2011 2014 2012 2013 2013

PALIPERIDONE PALMITATE - INVEGA SUSTENNA Oct 27, 2012 N022264 001 5254556 Apr 27, 2013 5254556*PED Dec 16, 2012 5352459 Jun 16, 2013 5352459*PED May 12, 2017 6077843 Nov 12, 2017 6077843*PED Nov 10, 2018 6555544 May 10, 2019 6555544*PED PALIPERIDONE PALMITATE - INVEGA SUSTENNA N022264 002 5254556 Oct 27, 2012 5254556*PED Apr 27, 2013 Dec 16, 2012 5352459 Jun 16, 2013 5352459*PED May 12, 2017 6077843 Nov 12, 2017 6077843*PED Nov 10, 2018 6555544 May 10, 2019 6555544*PED PALIPERIDONE PALMITATE - INVEGA SUSTENNA Oct 27, 2012 N022264 003 5254556 Apr 27, 2013 5254556*PED Dec 16, 2012 5352459 Jun 16, 2013 5352459*PED May 12, 2017 6077843 Nov 12, 2017 6077843*PED Nov 10, 2018 6555544 May 10, 2019 6555544*PED PALIPERIDONE PALMITATE - INVEGA SUSTENNA Oct 27, 2012 N022264 004 5254556 Apr 27, 2013 5254556*PED Dec 16, 2012 5352459 Jun 16, 2013 5352459*PED May 12, 2017 6077843 Nov 12, 2017 6077843*PED Nov 10, 2018 6555544 May 10, 2019 6555544*PED

NDF NCE PED PED

Jul Dec Jun Jan

31, 19, 19, 31,

2012 2011 2012 2013

DS

DP DP DP DP

U-543

U-543 U-543

NDF NCE PED PED

Jul Dec Jun Jan

31, 19, 19, 31,

2012 2011 2012 2013

DS

DP DP DP DP

U-543

U-543 U-543

NDF NCE PED PED

Jul Dec Jun Jan

31, 19, 19, 31,

2012 2011 2012 2013

DS

DP DP DP DP

U-543

U-543 U-543

NDF NCE PED PED

Jul Dec Jun Jan

31, 19, 19, 31,

2012 2011 2012 2013

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

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PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DS DP DP DP DP U-543 U-543 U-543

EXCLUSIVITY CODE(S)
NDF NCE PED PED

PALIPERIDONE PALMITATE - INVEGA SUSTENNA Oct 27, 2012 N022264 005 5254556 Apr 27, 2013 5254556*PED Dec 16, 2012 5352459 Jun 16, 2013 5352459*PED May 12, 2017 6077843 Nov 12, 2017 6077843*PED Nov 10, 2018 6555544 May 10, 2019 6555544*PED PALONOSETRON HYDROCHLORIDE - ALOXI N021372 001 5202333 Apr 7947724 Jan 7947725 Jan 7960424 Jan PALONOSETRON HYDROCHLORIDE - ALOXI Apr N021372 002 5202333 Jan 7947724 Jan 7947725 Jan 7960424 PALONOSETRON HYDROCHLORIDE - ALOXI N022233 001 5202333 Apr

Jul Dec Jun Jan

31, 19, 19, 31,

2012 2011 2012 2013

13, 30, 30, 30,

2015 2024 2024 2024

DS

DP DP DP DP

U-528

13, 30, 30, 30,

2015 2024 2024 2024

DS

DP DP DP DP

U-901

13, 2015

DS

DP

U-528

NDF

Aug

22, 2011

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) - CREON N020725 001

I-625 M-93 NCE

Apr Jul Apr

30, 2013 29, 2013 30, 2014

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) - CREON N020725 002

I-625 M-93 NCE

Apr Jul Apr

30, 2013 29, 2013 30, 2014

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) - CREON N020725 003

I-625 M-93 NCE

Apr Jul Apr

30, 2013 29, 2013 30, 2014

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) - PANCREAZE N022523 001 PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) - PANCREAZE N022523 002 PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) - PANCREAZE N022523 003 PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) - PANCREAZE N022523 004 PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) - ZENPEP N022210 001 7658918 Feb 20, 2028 PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) - ZENPEP N022210 002 7658918 Feb 20, 2028 PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) - ZENPEP N022210 003 7658918 Feb 20, 2028 PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) - ZENPEP N022210 004 7658918 Feb 20, 2028 PANTOPRAZOLE SODIUM - PROTONIX N020987 001 5997903 Dec 5997903*PED Jun

NCE

Apr

12, 2015

NCE

Apr

12, 2015

NCE

Apr

12, 2015

NCE DP

Apr

12, 2015

NCE

Aug

27, 2014

DP

NCE

Aug

27, 2014

DP

NCE

Aug

27, 2014

DP

NCE

Aug

27, 2014

07, 2016 07, 2017

I-614 M-54 PED PED

Nov Nov May May

12, 12, 12, 12,

2012 2012 2013 2013

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 150 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)
I-614 M-54 PED PED

PANTOPRAZOLE SODIUM - PROTONIX N020987 002 5997903 Dec 5997903*PED Jun

07, 2016 07, 2017

Nov Nov May May

12, 12, 12, 12,

2012 2012 2013 2013

PANTOPRAZOLE SODIUM - PROTONIX N022020 001 7544370 7544370*PED 7550153 7550153*PED 7553498 7553498*PED 7838027 7838027*PED PANTOPRAZOLE SODIUM - PROTONIX N020988 001 6780881 6780881*PED 7351723 7351723*PED PARICALCITOL - ZEMPLAR N020819 001 5246925 5246925*PED 5587497 5587497*PED 5597815 5597815*PED 6136799 6136799*PED 6361758 6361758*PED PARICALCITOL - ZEMPLAR N020819 002 5246925 5246925*PED 5587497 5587497*PED 5597815 5597815*PED 6136799 6136799*PED 6361758 6361758*PED PARICALCITOL - ZEMPLAR N021606 001 5246925 5246925*PED 5587497 5587497*PED 5597815 5597815*PED PARICALCITOL - ZEMPLAR N021606 002 5246925 5246925*PED 5587497 5587497*PED 5597815 5597815*PED PARICALCITOL - ZEMPLAR N021606 003 5246925 5246925*PED 5587497 5587497*PED 5597815 5597815*PED

Jun Dec Sep Mar Sep Mar Sep Mar IV Nov May Nov May

07, 07, 30, 30, 30, 30, 30, 30,

2026 2026 2024 2025 2024 2025 2024 2025

DP U-859 U-859 DP U-859

I-614 M-54 PED PED

Nov Nov May May

12, 12, 12, 12,

2012 2012 2013 2013

17, 17, 17, 17,

2021 2022 2021 2022

DP DP

Apr Oct Dec Jun Jul Jan Apr Oct Apr Oct

17, 17, 24, 24, 13, 13, 08, 08, 08, 08,

2012 2012 2013 2014 2015 2016 2018 2018 2018 2018

U-314

U-1195

DP

Apr Oct Dec Jun Jul Jan Apr Oct Apr Oct

17, 17, 24, 24, 13, 13, 08, 08, 08, 08,

2012 2012 2013 2014 2015 2016 2018 2018 2018 2018

U-314

U-1195

DP

Apr Oct Dec Jun Jul Jan

17, 17, 24, 24, 13, 13,

2012 2012 2013 2014 2015 2016

U-671 DS U-1195

I-599

Jun

29, 2012

Apr Oct Dec Jun Jul Jan

17, 17, 24, 24, 13, 13,

2012 2012 2013 2014 2015 2016

U-671 DS U-1195

I-599

Jun

29, 2012

Apr Oct Dec Jun Jul Jan

17, 17, 24, 24, 13, 13,

2012 2012 2013 2014 2015 2016

U-671 DS U-1195

I-599

Jun

29, 2012

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 151 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)
PC

PAROXETINE HYDROCHLORIDE - PAROXETINE HYDROCHLORIDE A091427 001 PAROXETINE HYDROCHLORIDE - PAXIL N020031 001 5872132 May 5872132*PED Nov 5900423 May 5900423*PED Nov 6113944 Dec 6113944*PED Jun 6121291 Mar 6121291 Mar 6121291*PED Sep 6121291*PED Sep 6133289 May 6133289*PED Nov PAROXETINE HYDROCHLORIDE - PAXIL N020031 002 5872132 May 5872132*PED Nov 5900423 May 5900423*PED Nov 6113944 Dec 6113944*PED Jun 6121291 Mar 6121291 Mar 6121291*PED Sep 6121291*PED Sep 6133289 May 6133289*PED Nov PAROXETINE HYDROCHLORIDE - PAXIL N020031 003 5872132 May 5872132*PED Nov 5900423 May 5900423*PED Nov 6113944 Dec 6113944*PED Jun 6121291 Mar 6121291 Mar 6121291*PED Sep 6121291*PED Sep 6133289 May 6133289*PED Nov PAROXETINE HYDROCHLORIDE - PAXIL N020031 004 5872132 May 5872132*PED Nov 5900423 May 5900423*PED Nov 6113944 Dec 6113944*PED Jun 6121291 Mar 6121291 Mar 6121291*PED Sep 6121291*PED Sep 6133289 May 6133289*PED Nov

Nov

01, 2011

19, 19, 19, 19, 14, 14, 17, 17, 17, 17, 19, 19,

2015 2015 2015 2015 2014 2015 2017 2017 2017 2017 2015 2015

U-286 U-431 U-431 U-286 U-358 U-358

19, 19, 19, 19, 14, 14, 17, 17, 17, 17, 19, 19,

2015 2015 2015 2015 2014 2015 2017 2017 2017 2017 2015 2015

U-286 U-431 U-431 U-286 U-358 U-358

19, 19, 19, 19, 14, 14, 17, 17, 17, 17, 19, 19,

2015 2015 2015 2015 2014 2015 2017 2017 2017 2017 2015 2015

U-286 U-431 U-431 U-286 U-358 U-358

19, 19, 19, 19, 14, 14, 17, 17, 17, 17, 19, 19,

2015 2015 2015 2015 2014 2015 2017 2017 2017 2017 2015 2015

U-431 U-286 U-431 U-286 U-358 U-358

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 152 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)

PAROXETINE HYDROCHLORIDE - PAXIL N020031 005 5872132 May 5872132*PED Nov 5900423 May 5900423*PED Nov 6113944 Dec 6113944*PED Jun 6121291 Mar 6121291 Mar 6121291*PED Sep 6121291*PED Sep 6133289 May 6133289*PED Nov PAROXETINE HYDROCHLORIDE - PAXIL N020710 001 5811436 Sep 5811436*PED Mar 5872132 May 5872132*PED Nov 5900423 May 5900423*PED Nov 6121291 Mar 6121291 Mar 6121291*PED Sep 6121291*PED Sep 6133289 May 6133289*PED Nov PAROXETINE HYDROCHLORIDE - PAXIL N020885 001 5872132 May 5872132*PED Nov 5900423 May 5900423*PED Nov 6063927 Apr 6063927*PED Oct 6080759 May 6080759*PED Nov 6121291 Mar 6121291 Mar 6121291*PED Sep 6121291*PED Sep 6133289 May 6133289*PED Nov 6172233 Jan 6172233*PED Jul PAROXETINE HYDROCHLORIDE - PAXIL N020885 002 5872132 May 5872132*PED Nov 5900423 May 5900423*PED Nov 6063927 Apr 6063927*PED Oct 6080759 May 6080759*PED Nov 6121291 Mar 6121291 Mar 6121291*PED Sep 6121291*PED Sep 6133289 May 6133289*PED Nov 6172233 Jan 6172233*PED Jul

19, 19, 19, 19, 14, 14, 17, 17, 17, 17, 19, 19,

2015 2015 2015 2015 2014 2015 2017 2017 2017 2017 2015 2015

U-431 U-286 U-286 U-431 U-358 U-358

22, 22, 19, 19, 19, 19, 17, 17, 17, 17, 19, 19,

2015 2016 2015 2015 2015 2015 2017 2017 2017 2017 2015 2015

U-286 U-431 U-286 U-431 U-358 U-358

19, 19, 19, 19, 23, 23, 19, 19, 17, 17, 17, 17, 19, 19, 15, 15,

2015 2015 2015 2015 2019 2019 2015 2015 2017 2017 2017 2017 2015 2015 2018 2018

U-286 U-431 U-431 U-286 U-358 U-358

19, 19, 19, 19, 23, 23, 19, 19, 17, 17, 17, 17, 19, 19, 15, 15,

2015 2015 2015 2015 2019 2019 2015 2015 2017 2017 2017 2017 2015 2015 2018 2018

U-431 U-286 U-431 U-286 U-358 U-358

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 153 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)

PAROXETINE HYDROCHLORIDE - PAXIL N020885 003 5872132 May 5872132*PED Nov 5900423 May 5900423*PED Nov 6063927 Apr 6063927*PED Oct 6080759 May 6080759*PED Nov 6121291 Mar 6121291 Mar 6121291*PED Sep 6121291*PED Sep 6133289 May 6133289*PED Nov 6172233 Jan 6172233*PED Jul PAROXETINE HYDROCHLORIDE - PAXIL N020885 004 5872132 May 5872132*PED Nov 5900423 May 5900423*PED Nov 6062927 Apr 6063927*PED Oct 6080759 May 6080759*PED Nov 6121291 Mar 6121291 Mar 6121291*PED Sep 6121291*PED Sep 6133289 May 6133289*PED Nov 6172233 Jan 6172233*PED Jul PAROXETINE HYDROCHLORIDE - PAXIL CR N020936 001 5422123 Jun 5422123*PED Dec 5872132 May 5872132*PED Nov 5900423 May 5900423*PED Nov 6121291 Mar 6121291*PED Sep 6133289 May 6133289*PED Nov 6548084 Jul 6548084*PED Jan 7229640 Jul PAROXETINE HYDROCHLORIDE - PAXIL CR N020936 002 5422123 Jun 5422123*PED Dec 5872132 May 5872132*PED Nov 5900423 May 5900423*PED Nov 6121291 Mar 6121291*PED Sep 6133289 May 6133289*PED Nov 6548084 Jul 6548084*PED Jan 7229640 Jul

19, 19, 19, 19, 23, 23, 19, 19, 17, 17, 17, 17, 19, 19, 15, 15,

2015 2015 2015 2015 2019 2019 2015 2015 2017 2017 2017 2017 2015 2015 2018 2018

U-431 U-286 U-286 U-431 U-358 U-358

19, 19, 19, 19, 23, 23, 19, 19, 17, 17, 17, 17, 19, 19, 15, 15,

2015 2015 2015 2015 2019 2019 2015 2015 2017 2017 2017 2017 2015 2015 2018 2018

U-431 U-286 U-286 U-431 U-358 U-358

06, 06, 19, 19, 19, 19, 17, 17, 19, 19, 19, 19, 19,

2012 2012 2015 2015 2015 2015 2017 2017 2015 2015 2016 2017 2016

U-286 U-286 U-286 U-286

DP

U-816

06, 06, 19, 19, 19, 19, 17, 17, 19, 19, 19, 19, 19,

2012 2012 2015 2015 2015 2015 2017 2017 2015 2015 2016 2017 2016

U-286 U-286 U-286 U-286

DP

U-816

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 154 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)

PAROXETINE HYDROCHLORIDE - PAXIL CR Jun N020936 003 5422123 Dec 5422123*PED May 5872132 Nov 5872132*PED May 5900423 Nov 5900423*PED Mar 6121291 Sep 6121291*PED May 6133289 Nov 6133289*PED Jul 6548084 Jan 6548084*PED Jul 7229640 PAROXETINE MESYLATE - PEXEVA N021299 001 5874447 5874447 5874447 6703408 7598271 PAROXETINE MESYLATE - PEXEVA N021299 002 5874447 5874447 5874447 6703408 7598271 PAROXETINE MESYLATE - PEXEVA N021299 003 5874447 5874447 5874447 6703408 7598271 PAROXETINE MESYLATE - PEXEVA N021299 004 5874447 5874447 5874447 6703408 7598271

06, 06, 19, 19, 19, 19, 17, 17, 19, 19, 19, 19, 19,

2012 2012 2015 2015 2015 2015 2017 2017 2015 2015 2016 2017 2016

U-286 U-286 U-286 U-286

DP

U-816

Jun Jun Jun Oct Feb

10, 10, 10, 21, 11,

2017 2017 2017 2022 2023

U-286 U-518 U-46 DS DP DP

Jun Jun Jun Oct Feb

10, 10, 10, 21, 11,

2017 2017 2017 2022 2023

U-518 U-46 U-286 DS DP DP

Jun Jun Jun Oct Feb

10, 10, 10, 21, 11,

2017 2017 2017 2022 2023

U-518 U-46 U-286 DS DP DP

Jun Jun Jun Oct Feb

10, 10, 10, 21, 11,

2017 2017 2017 2022 2023

U-46 U-518 U-286 DS DP DP

PAZOPANIB HYDROCHLORIDE - VOTRIENT N022465 001 7105530 Dec 7262203 Dec PAZOPANIB HYDROCHLORIDE - VOTRIENT N022465 002 7105530 Dec 7262203 Dec PEGAPTANIB SODIUM - MACUGEN N021756 001 5919455 5932462 6011020 6051698 6113906 PEGVISOMANT - SOMAVERT N021106 001 5350836 5681809 5849535 5958879 6057292 6583115

19, 2021 19, 2021

DS DS

DP DP

NCE

Oct

19, 2014

19, 2021 19, 2021

DS DS

DP DP

NCE

Oct

19, 2014

Oct Aug Jan May Oct

27, 03, 04, 19, 27,

2013 2016 2017 2015 2013

DS DS DS DS DS

U-622

Sep Sep Mar Sep Sep Sep

27, 27, 25, 27, 21, 27,

2011 2011 2017 2011 2015 2011

U-507 U-507 DS U-507 U-507 U-507

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 155 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-507 U-507 DS U-507 U-507 U-507

EXCLUSIVITY CODE(S)

PEGVISOMANT - SOMAVERT N021106 002 5350836 5681809 5849535 5958879 6057292 6583115 PEGVISOMANT - SOMAVERT N021106 003 5350836 5681809 5849535 5958879 6057292 6583115 PEMETREXED DISODIUM - ALIMTA N021462 001 5217974*PED 5344932 5344932*PED 7772209 7772209*PED

Sep Sep Mar Sep Sep Sep

27, 27, 25, 27, 21, 27,

2011 2011 2017 2011 2015 2011

Sep Sep Mar Sep Sep Sep

27, 27, 25, 27, 21, 27,

2011 2011 2017 2011 2015 2011

U-507 U-507 DS U-507 U-507 U-507

Sep Jul Jan Nov May

29, 24, 24, 24, 24,

2011 2016 2017 2021 2022

DS

DP U-1077

I-601 I-571 M-61 PED PED PED PED

Jul Sep Mar Sep Aug Mar Jan

02, 26, 17, 17, 04, 26, 02,

2012 2011 2014 2014 2011 2012 2013

PEMETREXED DISODIUM - ALIMTA N021462 002 5217974*PED 5344932 5344932*PED 7772209 7772209*PED

Sep Jul Jan Nov May

29, 24, 24, 24, 24,

2011 2016 2017 2021 2022

DS

DP U-1077

I-601 I-571 M-61 PED PED PED PED

Jul Sep Mar Sep Aug Mar Jan

02, 26, 17, 17, 04, 26, 02,

2012 2011 2014 2014 2011 2012 2013

PEMIROLAST POTASSIUM - ALAMAST N021079 001 5034230*PED Jul PENCICLOVIR SODIUM - DENAVIR N020629 001 5840763 5866581 5916893 6124304 6469015 6579981

02, 2011

U-184

Sep Oct Sep Oct Oct Jun

01, 04, 01, 04, 22, 17,

2015 2014 2015 2014 2019 2020

U-501 U-501 U-501 U-501 U-501 U-501

PENTETATE CALCIUM TRISODIUM - PENTETATE CALCIUM TRISODIUM N021749 001 PENTETATE ZINC TRISODIUM - PENTETATE ZINC TRISODIUM N021751 001

ODE

Aug

11, 2011

ODE

Aug

11, 2011

PERFLUOROPOLYMETHYLISOPROPYL ETHER; POLYTETRAFLUOROETHYLENE - SKIN EXPOSURE REDUCTION PASTE AGAINST CHEMICAL WARFARE AGENTS N021084 001 5607979 May 30, 2015 PERFLUTREN - DEFINITY N021064 001 5527521 5585112 6033645

Feb Dec Jun

22, 2015 17, 2013 19, 2016

DP DP

U-665 U-665

PHENTERMINE HYDROCHLORIDE - SUPRENZA N202088 001 6149938 Jul 23, 2018 PHENTERMINE HYDROCHLORIDE - SUPRENZA N202088 002 6149938 Jul 23, 2018

DP

DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

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PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-967 DP DP U-967 DP

EXCLUSIVITY CODE(S)

PHENTOLAMINE MESYLATE - ORAVERSE N022159 001 6764678 May 6872390 May 7229630 Jun 7569230 Oct 7575757 Apr PIMECROLIMUS - ELIDEL N021302 001 5912238 5912238*PED 6352998 6352998*PED 6423722 6423722*PED

11, 11, 20, 17, 21,

2021 2021 2023 2023 2025

Jun Dec Oct Apr Jun Dec

15, 15, 26, 26, 26, 26,

2016 2016 2015 2016 2018 2018

PIOGLITAZONE HYDROCHLORIDE - ACTOS N021073 001 5965584 Jun 6150383 Jun 6150384 Jun 6166042 Jun 6166043 Jun 6172090 Jun 6211205 Jun 6271243 Jun 6303640 Aug 6329404 Jun PIOGLITAZONE HYDROCHLORIDE - ACTOS N021073 002 5965584 Jun 6150383 Jun 6150384 Jun 6166042 Jun 6166043 Jun 6172090 Jun 6211205 Jun 6271243 Jun 6303640 Aug 6329404 Jun PIOGLITAZONE HYDROCHLORIDE - ACTOS N021073 003 5965584 Jun 6150383 Jun 6150384 Jun 6166042 Jun 6166043 Jun 6172090 Jun 6211205 Jun 6271243 Jun 6303640 Aug 6329404 Jun

19, 19, 19, 19, 19, 19, 19, 19, 09, 19,

2016 2016 2016 2016 2016 2016 2016 2016 2016 2016

U-753 U-418 U-419 U-414 U-415 U-416 U-410 U-411 U-425 U-753

19, 19, 19, 19, 19, 19, 19, 19, 09, 19,

2016 2016 2016 2016 2016 2016 2016 2016 2016 2016

U-753 U-418 U-419 U-414 U-415 U-416 U-410 U-411 U-425 U-753

19, 19, 19, 19, 19, 19, 19, 19, 09, 19,

2016 2016 2016 2016 2016 2016 2016 2016 2016 2016

U-753 U-418 U-419 U-414 U-415 U-416 U-410 U-411 U-425 U-753

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM - ZOSYN N050684 001 6900184 Apr 14, 2023 7915229 Apr 14, 2023 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM - ZOSYN N050684 002 6900184 Apr 14, 2023 7915229 Apr 14, 2023 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM - ZOSYN N050684 003 6900184 Apr 14, 2023 7915229 Apr 14, 2023 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM - ZOSYN N050684 004 6900184 Apr 14, 2023 7915229 Apr 14, 2023

DP DP

U-282

DP DP

U-282

DP DP

U-282

DP DP

U-282

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

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PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM - ZOSYN IN PLASTIC CONTAINER DP N050750 001 6207661 Feb 22, 2019 DP U-282 6900184 Apr 14, 2023 DP Apr 14, 2023 7915229 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM - ZOSYN IN PLASTIC CONTAINER N050750 002 6207661 Feb 22, 2019 DP DP U-282 6900184 Apr 14, 2023 DP 7915229 Apr 14, 2023 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM - ZOSYN IN PLASTIC CONTAINER DP N050750 003 6207661 Feb 22, 2019 DP U-282 6900184 Apr 14, 2023 DP Apr 14, 2023 7915229 PITAVASTATIN CALCIUM - LIVALO N022363 001 5753675 5854259 5856336 6465477 7022713 PITAVASTATIN CALCIUM - LIVALO N022363 002 5753675 5854259 5856336 6465477 7022713 PITAVASTATIN CALCIUM - LIVALO N022363 003 5753675 5854259 5856336 6465477 7022713 PLERIXAFOR - MOZOBIL N022311 001 6987102 7897590 RE42152 POLIDOCANOL - ASCLERA N021201 001 POLIDOCANOL - ASCLERA N021201 002 PORFIMER SODIUM - PHOTOFRIN N020451 001 5438071 POSACONAZOLE - NOXAFIL N022003 001 5661151 5703079 6958337 PRALATREXATE - FOLOTYN N022468 001 6028071 7622470 PRALATREXATE - FOLOTYN N022468 002 6028071 7622470 Aug 01, 2012

May Dec Jan Dec Feb

19, 29, 05, 20, 19,

2015 2015 2016 2016 2024

DS DS

DP DP DP

U-998 U-998 U-998

NCE

Aug

03, 2014

May Dec Jan Dec Feb

19, 29, 05, 20, 19,

2015 2015 2016 2016 2024

DS DS

DP DP DP

U-998 U-998 U-998

NCE

Aug

03, 2014

May Dec Jan Dec Feb

19, 29, 05, 20, 19,

2015 2015 2016 2016 2024

DS DS

DP DP DP

U-998 U-998 U-998

NCE

Aug

03, 2014

Jul Jul Dec

22, 2023 22, 2023 10, 2013

U-936 U-936 DP

NCE ODE

Dec Dec

15, 2013 15, 2015

NCE

Mar

30, 2015

NCE

Mar

30, 2015

Jul Aug Oct

19, 2019 26, 2014 05, 2018

DS DS DS

DP DP DP

U-760 U-760 U-760

NCE

Sep

15, 2011

Jul May

16, 2017 31, 2025

DS

DP

U-1004 U-1015

NCE ODE

Sep Sep

24, 2014 24, 2016

Jul May

16, 2017 31, 2025

DS

DP

U-1004 U-1015

NCE ODE

Sep Sep

24, 2014 24, 2016

PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX N020667 001 6001861 Jan 16, 2018 6194445 Jan 16, 2018 PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX N020667 002 6001861 Jan 16, 2018 6194445 Jan 16, 2018

U-784 U-784

M-104

May

13, 2014

U-784 U-784

M-104

May

13, 2014

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 158 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-784 U-784

EXCLUSIVITY CODE(S)
M-104

PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX N020667 003 6001861 Jan 16, 2018 6194445 Jan 16, 2018 PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX N020667 005 6001861 Jan 16, 2018 6194445 Jan 16, 2018 PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX N020667 006 6001861 Jan 16, 2018 6194445 Jan 16, 2018 PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX N020667 007 6001861 Jan 16, 2018 6194445 Jan 16, 2018 PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX ER Apr 26, 2028 N022421 001 7695734 PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX ER N022421 002 7695734 Apr 26, 2028 PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX ER N022421 003 7695734 Apr 26, 2028 PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX ER N022421 004 7695734 Apr 26, 2028 PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX ER N022421 005 7695734 Apr 26, 2028 PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX ER N022421 006 7695734 Apr 26, 2028 PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX ER Apr 26, 2028 N022421 007 7695734 PRAMLINTIDE ACETATE - SYMLIN N021332 001 5686411 5814600 6114304 6608029 PRAMLINTIDE ACETATE - SYMLIN N021332 002 5686411 5814600 5814600 5814600 6114304 6114304 6608029 6608029 6608029

May

13, 2014

U-784 U-784

M-104

May

13, 2014

U-784 U-784

M-104

May

13, 2014

U-784 U-784

M-104

May

13, 2014

DP

I-623 NDF

Mar Feb

19, 2013 19, 2013

DP

I-623 NDF

Mar Feb

19, 2013 19, 2013

DP

I-623 NDF

Mar Feb

19, 2013 19, 2013

DP

I-623 NDF

Mar Feb

19, 2013 19, 2013

DP

I-623 NDF

Mar Feb

19, 2013 19, 2013

DP

I-623 NDF

Mar Feb

19, 2013 19, 2013

DP

I-623 NDF U-638 U-639 U-640 U-641

Mar Feb

19, 2013 19, 2013

Mar Sep Sep Sep

16, 29, 05, 07,

2019 2015 2017 2013

DS

DP

Mar Sep Sep Sep Sep Sep Sep Sep Sep

16, 29, 29, 29, 05, 05, 07, 07, 07,

2019 2015 2015 2015 2017 2017 2013 2013 2013

DS

DP

U-638 U-639 U-638 U-637 U-640 U-637 U-641 U-640 U-637

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 159 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DS DP U-638 U-638 U-637 U-639 U-640 U-637 U-641 U-640 U-637

EXCLUSIVITY CODE(S)

PRAMLINTIDE ACETATE - SYMLIN N021332 003 5686411 5814600 5814600 5814600 6114304 6114304 6608029 6608029 6608029

Mar Sep Sep Sep Sep Sep Sep Sep Sep

16, 29, 29, 29, 05, 05, 07, 07, 07,

2019 2015 2015 2015 2017 2017 2013 2013 2013

PRASUGREL HYDROCHLORIDE - EFFIENT Apr N022307 001 5288726 Jul 6693115 PRASUGREL HYDROCHLORIDE - EFFIENT Apr N022307 002 5288726 Jul 6693115 PRAVASTATIN SODIUM - PRAVACHOL Apr N019898 002 5622985 Oct 5622985*PED PRAVASTATIN SODIUM - PRAVACHOL N019898 003 5622985 Apr 5622985*PED Oct PRAVASTATIN SODIUM - PRAVACHOL Apr N019898 004 5622985 Oct 5622985*PED PRAVASTATIN SODIUM - PRAVACHOL N019898 008 5622985 Apr 5622985*PED Oct PREDNISOLONE ACETATE - FLO-PRED N022067 001 5881926 Mar 6071523 Jun 6102254 Mar 6399079 Jun 6656482 Jun PREDNISOLONE ACETATE - FLO-PRED N022067 002 5881926 Mar 6071523 Jun 6102254 Mar 6399079 Jun 6656482 Jun

14, 2017 03, 2021

DS DS

DP DP

U-991 U-991

NCE

Jul

10, 2014

14, 2017 03, 2021

DS DS

DP DP

U-991 U-991

NCE

Jul

10, 2014

22, 2014 22, 2014

U-335 U-335

22, 2014 22, 2014

U-335 U-335

22, 2014 22, 2014

U-335 U-335

22, 2014 22, 2014

U-335 U-335

16, 03, 11, 03, 03,

2016 2018 2013 2018 2018

DP DP DP DP DP

16, 03, 11, 03, 03,

2016 2018 2013 2018 2018 ODT 2018 2018 2019 ODT 2018 2018 2019 ODT 2018 2018 2019

DP DP DP DP DP

PREDNISOLONE SODIUM PHOSPHATE - ORAPRED N021959 001 6024981 Apr 09, 6221392 Apr 09, Nov 24, 6740341 PREDNISOLONE SODIUM PHOSPHATE - ORAPRED Apr 09, N021959 002 6024981 Apr 09, 6221392 Nov 24, 6740341 PREDNISOLONE SODIUM PHOSPHATE - ORAPRED Apr 09, N021959 003 6024981 Apr 09, 6221392 Nov 24, 6740341 PREGABALIN - LYRICA N021446 001 5563175 6001876 6001876 6197819 RE41920

DP DP DP

Y Y

DP DP DP

Y Y

DP DP DP

Y Y

Oct Dec Dec Dec Dec

08, 30, 30, 30, 30,

2013 2018 2018 2018 2018

U-661 U-55 U-819 DS DP U-1099

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 160 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-661 U-55 U-819 DS DP U-1099

EXCLUSIVITY CODE(S)

PREGABALIN - LYRICA N021446 002 5563175 6001876 6001876 6197819 RE41920 PREGABALIN - LYRICA N021446 003 5563175 6001876 6001876 6197819 RE41920 PREGABALIN - LYRICA N021446 004 5563175 6001876 6001876 6197819 RE41920 PREGABALIN - LYRICA N021446 005 5563175 6001876 6001876 6197819 RE41920 PREGABALIN - LYRICA N021446 006 5563175 6001876 6001876 6197819 RE41920 PREGABALIN - LYRICA N021446 007 5563175 6001876 6001876 6197819 RE41920 PREGABALIN - LYRICA N021446 008 5563175 6001876 6001876 6197819 RE41920 PREGABALIN - LYRICA N022488 001 5563175 6001876 6001876 6197819 RE41920

Oct Dec Dec Dec Dec

08, 30, 30, 30, 30,

2013 2018 2018 2018 2018

Oct Dec Dec Dec Dec

08, 30, 30, 30, 30,

2013 2018 2018 2018 2018

U-661 U-55 U-819 DS DP U-1099

Oct Dec Dec Dec Dec

08, 30, 30, 30, 30,

2013 2018 2018 2018 2018

U-661 U-55 U-819 DS DP U-1099

Oct Dec Dec Dec Dec

08, 30, 30, 30, 30,

2013 2018 2018 2018 2018

U-661 U-819 U-55 DS DP U-1099

Oct Dec Dec Dec Dec

08, 30, 30, 30, 30,

2013 2018 2018 2018 2018

U-661 U-55 U-819 DS DP U-1099

Oct Dec Dec Dec Dec

08, 30, 30, 30, 30,

2013 2018 2018 2018 2018

U-661 U-55 U-819 DS DP U-1099

Oct Dec Dec Dec Dec

08, 30, 30, 30, 30,

2013 2018 2018 2018 2018

U-661 U-55 U-819 DS DP U-1099

Oct Dec Dec Dec Dec

08, 30, 30, 30, 30,

2013 2018 2018 2018 2018

U-661 U-55 U-819 DS DP U-1099

PROCAINAMIDE HYDROCHLORIDE - PROCANBID N020545 001 5656296 Aug 12, 2014 PROCAINAMIDE HYDROCHLORIDE - PROCANBID N020545 002 5656296 Aug 12, 2014 PROGESTERONE - CRINONE N020701 001 5543150 PROGESTERONE - CRINONE N020701 002 5543150

Sep

15, 2013

U-209

Sep

15, 2013

U-209

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 161 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-856 U-856 U-880

EXCLUSIVITY CODE(S)

PROGESTERONE - ENDOMETRIN N022057 001 7300664 7320800 7393543

Nov Nov Nov

17, 2019 17, 2019 17, 2019

DP

PROPAFENONE HYDROCHLORIDE - RYTHMOL SR N021416 001 5681588 Oct 28, 2014 PROPAFENONE HYDROCHLORIDE - RYTHMOL SR N021416 002 5681588 Oct 28, 2014 PROPAFENONE HYDROCHLORIDE - RYTHMOL SR N021416 003 5681588 Oct 28, 2014 PROPOFOL - DIPRIVAN N019627 002 5714520 5714520*PED 5731355 5731355*PED 5731356 5731356*PED 5908869 5908869*PED

Mar Sep Mar Sep Mar Sep Mar Sep

22, 22, 22, 22, 22, 22, 22, 22,

2015 2015 2015 2015 2015 2015 2015 2015

U-217 U-217 U-218 U-218 U-270 U-270

PROPRANOLOL HYDROCHLORIDE - INNOPRAN XL N021438 001 6500454 Dec 31, 2022 PROPRANOLOL HYDROCHLORIDE - INNOPRAN XL N021438 002 6500454 Dec 31, 2022 QUAZEPAM - DORAL N018708 001 7608616 QUAZEPAM - DORAL N018708 003 7608616

Jun

03, 2028

U-1012

Jun

03, 2028

U-1012

QUETIAPINE FUMARATE - SEROQUEL N020639 001 4879288 Sep 4879288*PED Mar

26, 2011 26, 2012

DS

DP

U-550

NPP NPP PED PED PED

Dec Dec Jun Jun Nov

02, 02, 02, 02, 13,

2012 2012 2013 2013 2011

QUETIAPINE FUMARATE - SEROQUEL Sep N020639 002 4879288 Mar 4879288*PED

26, 2011 26, 2012

DS

DP

U-550

NPP NPP PED PED PED

Dec Dec Jun Jun Nov

02, 02, 02, 02, 13,

2012 2012 2013 2013 2011

QUETIAPINE FUMARATE - SEROQUEL N020639 003 4879288 Sep 4879288*PED Mar

26, 2011 26, 2012

DS

DP

U-550

NPP NPP PED PED PED

Dec Dec Jun Jun Nov

02, 02, 02, 02, 13,

2012 2012 2013 2013 2011

QUETIAPINE FUMARATE - SEROQUEL Sep N020639 004 4879288 Mar 4879288*PED

26, 2011 26, 2012

DS

DP

U-550

NPP NPP PED PED PED

Dec Dec Jun Jun Nov

02, 02, 02, 02, 13,

2012 2012 2013 2013 2011

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 162 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DS DP U-550

EXCLUSIVITY CODE(S)
NPP NPP PED PED PED

QUETIAPINE FUMARATE - SEROQUEL Sep N020639 005 4879288 Mar 4879288*PED

26, 2011 26, 2012

Dec Dec Jun Jun Nov

02, 02, 02, 02, 13,

2012 2012 2013 2013 2011

QUETIAPINE FUMARATE - SEROQUEL N020639 006 4879288 Sep 4879288*PED Mar

26, 2011 26, 2012

DS

DP

U-550

NPP NPP PED PED PED

Dec Dec Jun Jun Nov

02, 02, 02, 02, 13,

2012 2012 2013 2013 2011

QUETIAPINE FUMARATE - SEROQUEL N020639 007 4879288 Sep 4879288*PED Mar

26, 2011 26, 2012

DS

DP

U-550

NPP NPP PED PED PED

Dec Dec Jun Jun Nov

02, 02, 02, 02, 13,

2012 2012 2013 2013 2011

QUETIAPINE FUMARATE - SEROQUEL N022047 001 4879288 4879288 4879288 4879288*PED 5948437 5948437 5948437 5948437*PED

XR Sep Sep Sep Mar May May May Nov

26, 26, 26, 26, 28, 28, 28, 28,

2011 2011 2011 2012 2017 2017 2017 2017

DS DS DS

DP DP DP DP DP DP

U-601 U-814 U-839 U-839 U-814 U-601

D-117 I-618 I-576 I-575 I-574 PED PED PED PED

Oct Dec Oct Oct Oct Apr Apr Apr Apr

08, 02, 08, 08, 08, 08, 08, 08, 08,

2011 2012 2011 2011 2011 2012 2012 2012 2012

QUETIAPINE FUMARATE - SEROQUEL N022047 002 4879288 4879288 4879288 4879288*PED 5948437 5948437 5948437 5948437*PED

XR Sep Sep Sep Mar May May May Nov

26, 26, 26, 26, 28, 28, 28, 28,

2011 2011 2011 2012 2017 2017 2017 2017

DS DS DS

DP DP DP DP DP DP

U-601 U-814 U-839 U-814 U-601 U-839

D-117 I-618 I-576 I-575 I-574 PED PED PED PED

Oct Dec Oct Oct Oct Apr Apr Apr Apr

08, 02, 08, 08, 08, 08, 08, 08, 08,

2011 2012 2011 2011 2011 2012 2012 2012 2012

QUETIAPINE FUMARATE - SEROQUEL N022047 003 4879288 4879288 4879288 4879288*PED 5948437 5948437 5948437 5948437*PED

XR Sep Sep Sep Mar May May May Nov

26, 26, 26, 26, 28, 28, 28, 28,

2011 2011 2011 2012 2017 2017 2017 2017

DS DS DS

DP DP DP DP DP DP

U-839 U-601 U-814 U-601 U-814 U-839

D-117 I-618 I-576 I-575 I-574 PED PED PED PED

Oct Dec Oct Oct Oct Apr Apr Apr Apr

08, 02, 08, 08, 08, 08, 08, 08, 08,

2011 2012 2011 2011 2011 2012 2012 2012 2012

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 163 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE
XR Sep Sep Sep Mar May May May Nov

APPL/PROD NO

PATENT NO

PATENT CODES
DS DS DS DP DP DP DP DP DP U-814 U-601 U-839 U-814 U-601 U-839

PATENT DELIST REQUESTED

EXCLUSIVITY CODE(S)
D-117 I-618 I-576 I-575 I-574 PED PED PED PED

EXCLUSIVITY EXPIRATION DATE

QUETIAPINE FUMARATE - SEROQUEL N022047 004 4879288 4879288 4879288 4879288*PED 5948437 5948437 5948437 5948437*PED

26, 26, 26, 26, 28, 28, 28, 28,

2011 2011 2011 2012 2017 2017 2017 2017

Oct Dec Oct Oct Oct Apr Apr Apr Apr

08, 02, 08, 08, 08, 08, 08, 08, 08,

2011 2012 2011 2011 2011 2012 2012 2012 2012

QUETIAPINE FUMARATE - SEROQUEL N022047 005 4879288 4879288 4879288 4879288*PED 5948437 5948437 5948437 5948437*PED

XR Sep Sep Sep Mar May May May Nov

26, 26, 26, 26, 28, 28, 28, 28,

2011 2011 2011 2012 2017 2017 2017 2017

DS DS DS

DP DP DP DP DP DP

U-814 U-601 U-839 U-839 U-814 U-601

D-117 I-618 I-576 I-575 I-574 PED PED PED PED

Oct Dec Oct Oct Oct Apr Apr Apr Apr

08, 02, 08, 08, 08, 08, 08, 08, 08,

2011 2012 2011 2011 2011 2012 2012 2012 2012

QUINAPRIL HYDROCHLORIDE - ACCUPRIL N019885 001 5684016 Nov 5684016*PED May QUINAPRIL HYDROCHLORIDE - ACCUPRIL N019885 002 5684016 Nov 5684016*PED May QUINAPRIL HYDROCHLORIDE - ACCUPRIL N019885 003 5684016 Nov 5684016*PED May QUINAPRIL HYDROCHLORIDE - ACCUPRIL N019885 004 5684016 Nov 5684016*PED May QUININE SULFATE - QUALAQUIN N021799 001 RABEPRAZOLE SODIUM - ACIPHEX N020973 001 5045552 RABEPRAZOLE SODIUM - ACIPHEX N020973 002 5045552

04, 2014 04, 2015

U-210 U-210

04, 2014 04, 2015

U-210 U-210

04, 2014 04, 2015

U-210 U-210

04, 2014 04, 2015

U-210 U-210

ODE May 08, 2013 U-385

Aug

12, 2012

May

08, 2013

U-385

RALOXIFENE HYDROCHLORIDE - EVISTA N020815 001 5393763 Jul 5457117 Jul 5478847 Mar 5811120 Mar 5972383 Mar 6458811 Mar 6797719 Mar 6894064 Mar 6906086 Jul 6906086 Jul 8030330 Mar RE38968 Jul RE38968 Jul RE39049 Jul RE39049 Jul RE39050 Mar RE39050 Mar

28, 28, 02, 02, 02, 10, 10, 10, 28, 28, 10, 28, 28, 28, 28, 02, 02,

2012 2012 2014 2014 2014 2017 2017 2017 2012 2012 2017 2012 2012 2012 2012 2014 2014

U-114 U-114 U-114 U-287 U-825 U-657 U-662 U-657 U-662 U-657 U-662 U-657 U-657 U-662

Y Y Y

ODE

Sep

13, 2014

DS

DP DP DP

DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 164 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DS DP U-257 U-900 U-257 U-257

EXCLUSIVITY CODE(S)
NPP NCE

RALTEGRAVIR POTASSIUM - ISENTRESS N022145 001 7169780 Oct 7217713 Oct 7435734 Oct 7435734 Oct 7754731 Mar RALTEGRAVIR POTASSIUM - ISENTRESS N203045 001 RALTEGRAVIR POTASSIUM - ISENTRESS N203045 002 RAMELTEON - ROZEREM N021782 001 6034239 RAMIPRIL - ALTACE N019901 001 5403856 7368469 RAMIPRIL - ALTACE N019901 002 5403856 7368469 RAMIPRIL - ALTACE N019901 003 5403856 7368469 RAMIPRIL - ALTACE N019901 004 5403856 7368469 RAMIPRIL - ALTACE N022021 001 5403856 7368469 RAMIPRIL - ALTACE N022021 002 5403856 7368469 RAMIPRIL - ALTACE N022021 003 5403856 7368469 RAMIPRIL - ALTACE N022021 004 5403856 7368469

03, 21, 21, 21, 11,

2023 2022 2022 2022 2029

Dec Oct

21, 2014 12, 2012

DS

DP

NDF

Dec

21, 2014

NDF 22, 2019 DS DP U-674

Dec

21, 2014

Jul

M-82

Oct

20, 2011

Apr Aug

04, 2012 30, 2020

U-71 U-871

Apr Aug

04, 2012 30, 2020

U-71 U-871

Apr Aug

04, 2012 30, 2020

U-71 U-871

Apr Aug

04, 2012 30, 2020

U-71 U-871

Apr Aug

04, 2012 30, 2020

U-71 U-871

Apr Aug

04, 2012 30, 2020

U-71 U-871

Apr Aug

04, 2012 30, 2020

U-71 U-871

Apr Aug

04, 2012 30, 2020

U-71 U-871

RANITIDINE BISMUTH CITRATE - TRITEC N020559 001 5403830 Apr 04, 2012 5407688 Apr 04, 2012 Oct 10, 2012 5456925 Feb 11, 2014 5601848 May 13, 2014 5629297 RANOLAZINE - RANEXA N021526 001 6303607 6369062 6479496 6503911 6525057 6562826 6617328 6620814 6852724 6864258

U-200 U-201 U-202 U-186

May May May May May May May May May May

27, 27, 27, 27, 27, 27, 27, 27, 27, 27,

2019 2019 2019 2019 2019 2019 2019 2019 2019 2019

U-705 DP U-705 DP U-705 U-705 DP U-705 U-705 U-705 Y

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 165 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-705 DP U-705 DP U-705 U-705 DP U-705 U-705 U-705

EXCLUSIVITY CODE(S)

RANOLAZINE - RANEXA N021526 002 6303607 6369062 6479496 6503911 6525057 6562826 6617328 6620814 6852724 6864258 RAPACURONIUM BROMIDE - RAPLON N020984 001 5418226 RAPACURONIUM BROMIDE - RAPLON N020984 002 5418226 RASAGILINE MESYLATE - AZILECT N021641 001 5387612 5453446 5457133 5532415 5786390 6126968 7572834 7815942 RASAGILINE MESYLATE - AZILECT N021641 002 5387612 5453446 5457133 5532415 5786390 6126968 7572834 7815942 REGADENOSON - LEXISCAN N022161 001 6403567 6642210 7144872 7144872 7144872 7183264 7183264 7183264 7582617 7655636 7655637 7683037

May May May May May May May May May May

27, 27, 27, 27, 27, 27, 27, 27, 27, 27,

2019 2019 2019 2019 2019 2019 2019 2019 2019 2019

Apr

14, 2013

Apr

14, 2013

Feb Feb Feb Jul Feb Sep Dec Aug

07, 07, 07, 02, 07, 18, 05, 27,

2012 2017 2012 2013 2012 2016 2026 2027

U-219 U-219 DS DS DP DP DP DP DP

DS

U-219

Feb Feb Feb Jul Feb Sep Dec Aug

07, 07, 07, 02, 07, 18, 05, 27,

2012 2017 2012 2013 2012 2016 2026 2027

U-219 U-219 DS DS DP DP DP DP DP

DS

U-219

Apr Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun Jun

10, 22, 22, 22, 22, 22, 22, 22, 22, 22, 22, 22,

2022 2019 2019 2019 2019 2019 2019 2019 2019 2019 2019 2019

DS DS DS DS DS

DP DP DP DP DP DP DP DP

DS

DP

U-869 U-869 U-870 U-869 U-116 U-870 U-869 U-116 U-1003 U-869 U-869 U-1042

NCE

Apr

10, 2013

REMIFENTANIL HYDROCHLORIDE - ULTIVA N020630 001 5866591 Sep 10, 2017 Mar 10, 2018 5866591*PED REMIFENTANIL HYDROCHLORIDE - ULTIVA N020630 002 5866591 Sep 10, 2017 Mar 10, 2018 5866591*PED REMIFENTANIL HYDROCHLORIDE - ULTIVA N020630 003 5866591 Sep 10, 2017 Mar 10, 2018 5866591*PED REPAGLINIDE - PRANDIN N020741 001 6677358 REPAGLINIDE - PRANDIN N020741 002 6677358

DP

DP

DP

Jun

12, 2018

DS

DP

U-968

Jun

12, 2018

DS

DP

U-968

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

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PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DS DP U-968

EXCLUSIVITY CODE(S)

REPAGLINIDE - PRANDIN N020741 003 6677358 RETAPAMULIN - ALTABAX N022055 001 7875630 RE39128 RIBAVIRIN - COPEGUS N021511 001 RIBAVIRIN - REBETOL N020903 001 6172046 6172046 6172046*PED 6177074 6177074 6177074*PED 6461605 6461605 6461605*PED 6472373 6472373 6472373*PED 6524570 6524570 6524570*PED RIBAVIRIN - REBETOL N020903 002 6172046 6172046 6172046*PED 6177074 6177074 6177074*PED 6461605 6461605 6461605*PED 6472373 6472373 6472373*PED 6524570 6524570 6524570*PED RIBAVIRIN - REBETOL N021546 001 6172046 6172046 6172046*PED 6177074 6177074*PED 6461605 6461605 6461605*PED 6472373 6472373*PED 6524570 6524570*PED 6790837 6790837*PED RIBAVIRIN - VIRAZOLE N018859 001 6150337 RIFAXIMIN - XIFAXAN N021361 001 7045620 7612199 7902206 7906542 7928115

Jun

12, 2018

Feb Apr

14, 2027 12, 2021

DS DS

NCE DP U-805

Apr

12, 2012

NPP Sep Sep Mar Nov Nov May Nov Nov May Sep Sep Mar Nov Nov May 21, 21, 21, 01, 01, 01, 01, 01, 01, 21, 21, 21, 01, 01, 01, 2017 2017 2018 2016 2016 2017 2016 2016 2017 2017 2017 2018 2016 2016 2017 U-1014 U-377 U-377 U-1013 U-454 U-454 U-478 U-1013 U-478 U-479 U-1014 U-479 U-499 U-1013 U-499

Aug

09, 2014

Sep Sep Mar Nov Nov May Nov Nov May Sep Sep Mar Nov Nov May

21, 21, 21, 01, 01, 01, 01, 01, 01, 21, 21, 21, 01, 01, 01,

2017 2017 2018 2016 2016 2017 2016 2016 2017 2017 2017 2018 2016 2016 2017

U-377 U-1014 U-377 U-1013 U-454 U-454 U-1013 U-478 U-478 U-1014 U-479 U-479 U-499 U-1013 U-499

Sep Sep Mar Nov May Nov Nov May Sep Mar Nov May Apr Oct

21, 21, 21, 01, 01, 01, 01, 01, 21, 21, 01, 01, 05, 05,

2017 2017 2018 2016 2017 2016 2016 2017 2017 2018 2016 2017 2023 2023

U-521 U-1014 U-521 U-1013 U-521 U-1013 U-521 U-521 U-521 U-1013 DP U-1014

Nov

21, 2017

U-400

Jun Jun Jun Jun Jul

19, 19, 19, 01, 24,

2024 2024 2024 2025 2029

DS DS DS DS

DP DP DP DP U-1121

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

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PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DS DS DS DS

EXCLUSIVITY CODE(S)
NP ODE

RIFAXIMIN - XIFAXAN N022554 001 7045620 7612199 7902206 7906542

Jun Jun Jun Jun

19, 19, 19, 01,

2024 2024 2024 2025

DP DP DP

Mar Mar

24, 2013 24, 2017

RILPIVIRINE HYDROCHLORIDE - EDURANT Feb 26, 2021 N202022 001 6838464 Dec 20, 2019 7067522 Apr 14, 2023 7125879 Apr 14, 2023 7638522 RILUZOLE - RILUTEK N020599 001 5527814 RISEDRONATE SODIUM - ACTONEL N020835 001 5583122 5583122*PED 6096342 6096342*PED 6165513 6165513*PED RISEDRONATE SODIUM - ACTONEL N020835 002 5583122 5583122*PED 6096342 6096342*PED 6165513 6165513*PED RISEDRONATE SODIUM - ACTONEL N020835 003 5583122 5583122 5583122*PED 5994329 5994329*PED 6015801 6015801*PED 6096342 6096342*PED 6165513 6165513*PED 6432932 6432932*PED 6465443 6465443*PED RISEDRONATE SODIUM - ACTONEL N020835 004 5583122 5583122*PED 6096342 6096342*PED 6165513 6165513*PED RISEDRONATE SODIUM - ACTONEL N020835 005 5583122 5583122*PED 6165513 6165513*PED 7192938 7192938*PED 7718634 7718634*PED

DS DS DS

DP DP DP DP

NCE U-1153

May

20, 2016

Jun

18, 2013

Dec Jun Nov May Jun Dec

10, 10, 22, 22, 10, 10,

2013 2014 2011 2012 2018 2018

U-222

M-61 PED

Jul Jan

23, 2012 23, 2013

Dec Jun Nov May Jun Dec

10, 10, 22, 22, 10, 10,

2013 2014 2011 2012 2018 2018

U-222

M-61 PED

Jul Jan

23, 2012 23, 2013

Dec Dec Jun Jul Jan Jul Jan Nov May Jun Dec Jul Jan Aug Feb

10, 10, 10, 17, 17, 17, 17, 22, 22, 10, 10, 17, 17, 14, 14,

2013 2013 2014 2018 2019 2018 2019 2011 2012 2018 2018 2018 2019 2018 2019

DS DS

DP DP

U-756 U-222 U-353 U-353

M-61 PED

Jul Jan

23, 2012 23, 2013

DP DP U-595 DP

Dec Jun Nov May Jun Dec

10, 10, 22, 22, 10, 10,

2013 2014 2011 2012 2018 2018

DS

DP DP DP

U-353 U-353

M-61 PED

Jul Jan

23, 2012 23, 2013

Dec Jun Jun Dec May Nov May Nov

10, 10, 10, 10, 06, 06, 06, 06,

2013 2014 2018 2018 2023 2023 2023 2023

DS

DP DP

U-353

M-61 PED PED

Jul Jan Oct

23, 2012 23, 2013 22, 2011

U-353 U-662

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

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PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DS DP DP DP DP U-662 U-662 U-662 U-662

EXCLUSIVITY CODE(S)
NDF

RISEDRONATE SODIUM - ATELVIA N022560 001 5583122 5583122*PED 5622721 7645459 7645460 RISPERIDONE - RISPERDAL N020588 001 5453425 5453425*PED 5616587 5616587*PED RE39181 RE39181*PED RISPERIDONE - RISPERDAL N021444 001 5648093 5648093*PED 6224905 6224905*PED RISPERIDONE - RISPERDAL N021444 002 5648093 5648093*PED 6224905 6224905*PED RISPERIDONE - RISPERDAL N021444 003 5648093 5648093*PED 6224905 6224905*PED RISPERIDONE - RISPERDAL N021444 004 5648093 5648093*PED 6224905 6224905*PED RISPERIDONE - RISPERDAL N021444 005 5648093 5648093*PED 6224905 6224905*PED

Dec Jun Apr Jan Jan

10, 10, 21, 09, 09,

2013 2014 2014 2028 2028

Oct

08, 2013

Jul Jan Jul Jan Jul Jan

11, 11, 11, 11, 11, 11,

2014 2015 2014 2015 2014 2015

DP Y DP

Jul Jan Jun Dec

15, 15, 10, 10,

2014 2015 2017 2017

DP DP

Jul Jan Jun Dec

15, 15, 10, 10,

2014 2015 2017 2017

DP DP

Jul Jan Jun Dec

15, 15, 10, 10,

2014 2015 2017 2017

DP DP

Jul Jan Jun Dec

15, 15, 10, 10,

2014 2015 2017 2017

DP DP

Jul Jan Jun Dec

15, 15, 10, 10,

2014 2015 2017 2017

DP DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

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PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-543 U-972 DP DP DP U-543 DP U-543 DP DP DP DP DP

EXCLUSIVITY CODE(S)
I-597 I-596

RISPERIDONE - RISPERDAL CONSTA N021346 001 5688801 5688801 5688801*PED 5792477 5792477*PED 5916598 5916598*PED 5965168 5965168*PED 6110921 6110921*PED 6194006 6194006*PED 6368632 6368632*PED 6379703 6379703*PED 6403114 6403114*PED 6596316 6596316*PED 6667061 6667061*PED 7547452 7547452*PED RISPERIDONE - RISPERDAL CONSTA N021346 002 5688801 5688801 5688801*PED 5792477 5792477*PED 5916598 5916598*PED 5965168 5965168*PED 6110921 6110921*PED 6194006 6194006*PED 6368632 6368632*PED 6379703 6379703*PED 6403114 6403114*PED 6596316 6596316*PED 6667061 6667061*PED 7547452 7547452*PED

Nov Nov May May Nov May Nov Nov May Nov May Dec Jun Nov May Dec Jun May Nov Dec Jun May Nov Nov May

18, 18, 18, 02, 02, 02, 02, 19, 19, 19, 19, 30, 30, 19, 19, 30, 30, 02, 02, 30, 30, 25, 25, 19, 19,

2014 2014 2015 2017 2017 2017 2017 2013 2014 2013 2014 2018 2019 2013 2014 2018 2019 2017 2017 2018 2019 2020 2020 2013 2014

May May

15, 2012 15, 2012

Nov Nov May May Nov May Nov Nov May Nov May Dec Jun Nov May Dec Jun May Nov Dec Jun May Nov Nov May

18, 18, 18, 02, 02, 02, 02, 19, 19, 19, 19, 30, 30, 19, 19, 30, 30, 02, 02, 30, 30, 25, 25, 19, 19,

2014 2014 2015 2017 2017 2017 2017 2013 2014 2013 2014 2018 2019 2013 2014 2018 2019 2017 2017 2018 2019 2020 2020 2013 2014

U-543 U-972 DP DP DP U-543 DP U-543 DP DP DP DP DP

I-597 I-596

May May

15, 2012 15, 2012

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

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PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-543 U-972 DP DP DP U-543 DP U-543 DP DP DP DP DP

EXCLUSIVITY CODE(S)
I-597 I-596

RISPERIDONE - RISPERDAL CONSTA N021346 003 5688801 5688801 5688801*PED 5792477 5792477*PED 5916598 5916598*PED 5965168 5965168*PED 6110921 6110921*PED 6194006 6194006*PED 6368632 6368632*PED 6379703 6379703*PED 6403114 6403114*PED 6596316 6596316*PED 6667061 6667061*PED 7547452 7547452*PED RISPERIDONE - RISPERDAL CONSTA N021346 004 5688801 5688801 5688801*PED 5792477 5792477*PED 5916598 5916598*PED 5965168 5965168*PED 6110503 6110503*PED 6110921 6110921*PED 6194006 6194006*PED 6368632 6368632*PED 6379703 6379703*PED 6403114 6403114*PED 6596316 6596316*PED 6667061 6667061*PED 7547452 7547452*PED

Nov Nov May May Nov May Nov Nov May Nov May Dec Jun Nov May Dec Jun May Nov Dec Jun May Nov Nov May

18, 18, 18, 02, 02, 02, 02, 19, 19, 19, 19, 30, 30, 19, 19, 30, 30, 02, 02, 30, 30, 25, 25, 19, 19,

2014 2014 2015 2017 2017 2017 2017 2013 2014 2013 2014 2018 2019 2013 2014 2018 2019 2017 2017 2018 2019 2020 2020 2013 2014

May May

15, 2012 15, 2012

Nov Nov May May Nov May Nov Nov May May Nov Nov May Dec Jun Nov May Dec Jun May Nov Dec Jun May Nov Nov May

18, 18, 18, 02, 02, 02, 02, 19, 19, 02, 02, 19, 19, 30, 30, 19, 19, 30, 30, 02, 02, 30, 30, 25, 25, 19, 19,

2014 2014 2015 2017 2017 2017 2017 2013 2014 2017 2017 2013 2014 2018 2019 2013 2014 2018 2019 2017 2017 2018 2019 2020 2020 2013 2014

U-972 U-543 DP DP DP DP U-543 DP U-543 DP DP DP DP DP

I-597 I-596

May May

15, 2012 15, 2012

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 171 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)

RITONAVIR - NORVIR N020659 001 5484801 5484801*PED 5541206 5541206*PED 5635523 5635523*PED 5648497 5648497*PED 5674882 5674882*PED 5948436 5948436*PED 6037157 6037157*PED 6703403 6703403*PED RITONAVIR - NORVIR N020680 001 5541206 5541206*PED 5635523 5635523*PED 5648497 5648497*PED 5948436 5948436*PED RITONAVIR - NORVIR N020945 001 5541206 5541206*PED 5635523 5635523*PED 5648497 5648497*PED 5674882 5674882*PED 5948436 5948436*PED 6037157 6037157*PED 6232333 6232333*PED 6703403 6703403*PED 7141593 7141593*PED 7432294 7432294*PED RITONAVIR - NORVIR N022417 001 5541206 5541206*PED 5635523 5635523*PED 5648497 5648497*PED 5674882 5674882*PED 6037157 6037157*PED 6703403 6703403*PED 7148359 7148359*PED 7364752 7364752*PED

Jan Jul Jul Jan Jul Jan Jul Jan Jul Jan Sep Mar Jun Dec Jun Dec

28, 28, 30, 30, 30, 30, 15, 15, 30, 30, 13, 13, 26, 26, 26, 26,

2014 2014 2013 2014 2013 2014 2014 2015 2013 2014 2013 2014 2016 2016 2016 2016

U-140 U-190

U-688 DP

U-564

Jul Jan Jun Dec Jul Jan Sep Mar

30, 30, 03, 03, 15, 15, 13, 13,

2013 2014 2014 2014 2014 2015 2013 2014

U-140 U-190

Jul Jan Jul Jan Jul Jan Jul Jan Sep Mar Jun Dec Nov May Jun Dec May Nov May Nov

30, 30, 30, 30, 15, 15, 30, 30, 13, 13, 26, 26, 07, 07, 26, 26, 22, 22, 22, 22,

2013 2014 2013 2014 2014 2015 2013 2014 2013 2014 2016 2016 2017 2018 2016 2016 2020 2020 2020 2020

U-348 U-347

U-895 DP U-895

U-564 DP DP

Jul Jan Jul Jan Jul Jan Jul Jan Jun Dec Jun Dec Jul Jan Nov May

30, 30, 30, 30, 15, 15, 30, 30, 26, 26, 26, 26, 19, 19, 10, 10,

2013 2014 2013 2014 2014 2015 2013 2014 2016 2016 2016 2016 2019 2020 2020 2021

DS

DP

U-688 U-688

DS U-688 U-688 U-688 DP DP U-688

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

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PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DS DS DP U-1167

EXCLUSIVITY CODE(S)
NCE

RIVAROXABAN - XARELTO N022406 001 7157456 7585860 7592339 RIVAROXABAN - XARELTO N202439 001 7157456 7585860 7592339 7592339 RIVAROXABAN - XARELTO N202439 002 7157456 7585860 7592339 7592339 RIVASTIGMINE - EXELON N022083 001 4948807 5602176 6316023 6335031 RIVASTIGMINE - EXELON N022083 002 4948807 5602176 6316023 6335031

Feb Dec Dec

08, 2021 11, 2020 11, 2020

Jul

01, 2016

Feb Dec Dec Dec

08, 11, 11, 11,

2021 2020 2020 2020

DS DS

DP U-1167 U-1200

I-643 NCE

Nov Jul

04, 2014 01, 2016

Feb Dec Dec Dec

08, 11, 11, 11,

2021 2020 2020 2020

DS DS

DP U-1167 U-1200

I-643 NCE

Nov Jul

04, 2014 01, 2016

Aug Feb Jan Jan

14, 11, 08, 08,

2012 2014 2019 2019

DS DS

DP DP DP

U-322 U-322

Aug Feb Jan Jan

14, 11, 08, 08,

2012 2014 2019 2019

DS DS

DP DP DP

U-322 U-322

RIVASTIGMINE TARTRATE - EXELON N020823 003 4948807 Aug 5602176 Feb RIVASTIGMINE TARTRATE - EXELON N020823 004 4948807 Aug 5602176 Feb RIVASTIGMINE TARTRATE - EXELON N020823 005 4948807 Aug 5602176 Feb RIVASTIGMINE TARTRATE - EXELON N020823 006 4948807 Aug 5602176 Feb RIVASTIGMINE TARTRATE - EXELON Aug N021025 001 4948807 Feb 5602176 RIZATRIPTAN BENZOATE - MAXALT N020864 001 5298520 5298520*PED 5602162 5602162*PED RIZATRIPTAN BENZOATE - MAXALT N020864 002 5298520 5298520*PED 5602162 5602162*PED

14, 2012 11, 2014

DS

U-322 U-322

14, 2012 11, 2014

DS

U-322 U-322

14, 2012 11, 2014

DS

U-322 U-322

14, 2012 11, 2014

DS

U-322 U-322

14, 2012 11, 2014

DS

U-322 U-322

Jun Dec Feb Aug

29, 29, 11, 11,

2012 2012 2014 2014

DS

DP

U-240 Y

NPP PED

Dec Jun

15, 2014 15, 2015

Jun Dec Feb Aug

29, 29, 11, 11,

2012 2012 2014 2014

DS

DP

U-240 Y

NPP PED

Dec Jun

15, 2014 15, 2015

RIZATRIPTAN BENZOATE - MAXALT-MLT N020865 001 5298520 Jun 5298520*PED Dec 5457895 Oct 5457895*PED Apr Feb 5602162 Aug 5602162*PED

29, 29, 01, 01, 11, 11,

2012 2012 2013 2014 2014 2014

DS

DP DP

U-240

NPP PED Y

Dec Jun

15, 2014 15, 2015

U-240

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

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PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DS DP DP U-240 U-240

EXCLUSIVITY CODE(S)
NPP PED

RIZATRIPTAN BENZOATE - MAXALT-MLT Jun N020865 002 5298520 Dec 5298520*PED Oct 5457895 Apr 5457895*PED Feb 5602162 Aug 5602162*PED ROCURONIUM BROMIDE - ZEMURON N020214 001 ROCURONIUM BROMIDE - ZEMURON N020214 002 ROCURONIUM BROMIDE - ZEMURON N020214 003 ROFECOXIB - VIOXX N021042 001 5474995 5474995*PED 5691374 5691374*PED 6063811 6063811*PED 6239173 6239173*PED ROFECOXIB - VIOXX N021042 002 5474995 5474995*PED 5691374 5691374*PED 6063811 6063811*PED 6239173 6239173*PED ROFECOXIB - VIOXX N021042 003 5474995 5474995*PED 5691374 5691374*PED 6063811 6063811*PED 6239173 6239173*PED ROFECOXIB - VIOXX N021052 001 5474995 5474995*PED 5691374 5691374*PED 6063811 6063811*PED 6239173 6239173*PED ROFECOXIB - VIOXX N021052 002 5474995 5474995*PED 5691374 5691374*PED 6063811 6063811*PED 6239173 6239173*PED

29, 29, 01, 01, 11, 11,

2012 2012 2013 2014 2014 2014

Dec Jun

15, 2014 15, 2015

NPP PED

Aug Feb

28, 2011 28, 2012

NPP PED

Aug Feb

28, 2011 28, 2012

NPP PED Jun Dec May Nov May Nov Jun Dec 24, 24, 18, 18, 06, 06, 24, 24, 2013 2013 2015 2015 2017 2017 2013 2013 DS DP U-602

Aug Feb

28, 2011 28, 2012

U-602 DS DP U-602

Jun Dec May Nov May Nov Jun Dec

24, 24, 18, 18, 06, 06, 24, 24,

2013 2013 2015 2015 2017 2017 2013 2013

DS

DP

U-602

U-602 DS DP U-602

Jun Dec May Nov May Nov Jun Dec

24, 24, 18, 18, 06, 06, 24, 24,

2013 2013 2015 2015 2017 2017 2013 2013

DS

DP

U-602

U-602 DS DP U-602

Jun Dec May Nov May Nov Jun Dec

24, 24, 18, 18, 06, 06, 24, 24,

2013 2013 2015 2015 2017 2017 2013 2013

U-266

U-266

Jun Dec May Nov May Nov Jun Dec

24, 24, 18, 18, 06, 06, 24, 24,

2013 2013 2015 2015 2017 2017 2013 2013

U-266

U-266

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

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PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DS DP U-1115

EXCLUSIVITY CODE(S)
NCE

ROFLUMILAST - DALIRESP N022522 001 5712298 ROMIDEPSIN - ISTODAX N022393 001 4977138 7608280 7611724

Jan

27, 2015

Feb

28, 2016

Jul Aug Aug

06, 2012 22, 2021 22, 2021

DS DS DS

DP

NCE ODE ODE

Nov Jun Nov

05, 2014 16, 2018 05, 2016

ROPINIROLE HYDROCHLORIDE - REQUIP XL N022008 001 5422123 Jun 06, 2012 7927624 Dec 02, 2021 ROPINIROLE HYDROCHLORIDE - REQUIP XL N022008 002 5422123 Jun 06, 2012 7927624 Dec 02, 2021 ROPINIROLE HYDROCHLORIDE - REQUIP XL N022008 003 5422123 Jun 06, 2012 7927624 Dec 02, 2021 ROPINIROLE HYDROCHLORIDE - REQUIP XL N022008 004 5422123 Jun 06, 2012 7927624 Dec 02, 2021 ROPINIROLE HYDROCHLORIDE - REQUIP XL N022008 005 5422123 Jun 06, 2012 7927624 Dec 02, 2021 ROPINIROLE HYDROCHLORIDE - REQUIP XL N022008 006 5422123 Jun 06, 2012 7927624 Dec 02, 2021 ROPIVACAINE HYDROCHLORIDE MONOHYDRATE - NAROPIN N020533 001 5670524 May 26, 2014 DS DS 5834489 May 26, 2014 ROPIVACAINE HYDROCHLORIDE MONOHYDRATE - NAROPIN DS N020533 003 5670524 May 26, 2014 5834489 May 26, 2014 DS ROPIVACAINE HYDROCHLORIDE MONOHYDRATE - NAROPIN N020533 004 5670524 May 26, 2014 DS 5834489 May 26, 2014 DS ROPIVACAINE HYDROCHLORIDE MONOHYDRATE - NAROPIN DS N020533 005 5670524 May 26, 2014 May 26, 2014 DS 5834489 ROSIGLITAZONE MALEATE - AVANDIA N021071 002 5002953 Sep Sep 5002953 Sep 5002953 Mar 5002953*PED Apr 5741803 Apr 5741803 Oct 5741803*PED Feb 6288095 Aug 6288095*PED Apr 7358366 Oct 7358366*PED

DP
DP U-20
DP
DP U-20

DP DP

U-20

DP DP

U-20

DP DP

U-20

DP DP

U-20

DP DP

U-833 U-838

DP DP

U-833
U-838

DP DP

U-833 U-838

DP DP

U-833 U-838

17, 17, 17, 17, 21, 21, 21, 11, 11, 19, 19,

2011 2011 2011 2012 2015 2015 2015 2017 2017 2020 2020

DS DS DS DS DS

DP DP DP DP DP

U-840 U-329 U-628 U-628 U-329 U-420 Y Y Y

DS

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

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PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DS DS DS DS DS DP DP DP DP DP U-840 U-329 U-628 U-628 U-329 U-420 DS

EXCLUSIVITY CODE(S)

ROSIGLITAZONE MALEATE - AVANDIA Sep N021071 003 5002953 Sep 5002953 Sep 5002953 Mar 5002953*PED Apr 5741803 Apr 5741803 Oct 5741803*PED Feb 6288095 Aug 6288095*PED Apr 7358366 Oct 7358366*PED ROSIGLITAZONE MALEATE - AVANDIA Sep N021071 004 5002953 Sep 5002953 Sep 5002953 Mar 5002953*PED Apr 5741803 Apr 5741803 Oct 5741803*PED Feb 6288095 Aug 6288095*PED Apr 7358366 Oct 7358366*PED ROSUVASTATIN CALCIUM - CRESTOR N021366 002 6316460 6316460*PED 6858618 6858618*PED 7030152 7030152*PED 7964614 7964614*PED RE37314 RE37314*PED ROSUVASTATIN CALCIUM - CRESTOR N021366 003 6316460 6316460*PED 6858618 6858618*PED 7030152 7030152*PED 7964614 7964614*PED RE37314 RE37314*PED ROSUVASTATIN CALCIUM - CRESTOR N021366 004 6316460 6316460*PED 6858618 6858618*PED 7030152 7030152*PED 7964614 7964614*PED RE37314 RE37314*PED

17, 17, 17, 17, 21, 21, 21, 11, 11, 19, 19,

2011 2011 2011 2012 2015 2015 2015 2017 2017 2020 2020

Y Y Y

17, 17, 17, 17, 21, 21, 21, 11, 11, 19, 19,

2011 2011 2011 2012 2015 2015 2015 2017 2017 2020 2020

DS DS DS DS DS

DP DP DP DP DP

U-329 U-628 U-840 U-628 U-329 U-420 Y Y Y

DS

Aug Feb Dec Jun Apr Oct Apr Oct Jan Jul

04, 04, 17, 17, 02, 02, 02, 02, 08, 08,

2020 2021 2021 2022 2018 2018 2018 2018 2016 2016

DP U-618 U-1032 U-1032 DS

I-621 I-611 I-573 PED PED

Feb Oct Nov Apr May

08, 16, 06, 16, 06,

2013 2012 2011 2013 2012

Aug Feb Dec Jun Apr Oct Apr Oct Jan Jul

04, 04, 17, 17, 02, 02, 02, 02, 08, 08,

2020 2021 2021 2022 2018 2018 2018 2018 2016 2016

DP U-618 U-1032 U-1032 DS

I-621 I-611 I-573 PED PED

Feb Oct Nov Apr May

08, 16, 06, 16, 06,

2013 2012 2011 2013 2012

Aug Feb Dec Jun Apr Oct Apr Oct Jan Jul

04, 04, 17, 17, 02, 02, 02, 02, 08, 08,

2020 2021 2021 2022 2018 2018 2018 2018 2016 2016

DP U-618 U-1032 U-1032 DS

I-621 I-611 I-573 PED PED

Feb Oct Nov Apr May

08, 16, 06, 16, 06,

2013 2012 2011 2013 2012

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 176 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DP U-618 U-1032 U-1032 DS

EXCLUSIVITY CODE(S)
I-621 I-611 I-573 PED PED

ROSUVASTATIN CALCIUM - CRESTOR N021366 005 6316460 6316460*PED 6858618 6858618*PED 7030152 7030152*PED 7964614 7964614*PED RE37314 RE37314*PED ROTIGOTINE - NEUPRO N021829 001 6699498 6884434 7413747 ROTIGOTINE - NEUPRO N021829 002 6699498 6884434 7413747 ROTIGOTINE - NEUPRO N021829 003 6699498 6884434 7413747 RUFINAMIDE - BANZEL N021911 001 6740669 8076362 RUFINAMIDE - BANZEL N021911 002 6740669 8076362 RUFINAMIDE - BANZEL N021911 003 6740669 8076362 RUFINAMIDE - BANZEL N201367 001 6740669

Aug Feb Dec Jun Apr Oct Apr Oct Jan Jul

04, 04, 17, 17, 02, 02, 02, 02, 08, 08,

2020 2021 2021 2022 2018 2018 2018 2018 2016 2016

Feb Oct Nov Apr May

08, 16, 06, 16, 06,

2013 2012 2011 2013 2012

Nov Mar Mar

27, 2020 30, 2021 18, 2019

DP DP DP

NCE

May

09, 2012

Nov Mar Mar

27, 2020 30, 2021 18, 2019

DP DP DP

NCE

May

09, 2012

Nov Mar Mar

27, 2020 30, 2021 18, 2019

DP DP DP

NCE

May

09, 2012

Nov Jun

14, 2022 08, 2018

DS

DP DP

NCE ODE

Nov Nov

14, 2013 14, 2015

Nov Jun

14, 2022 08, 2018

DS

DP DP

NCE ODE

Nov Nov

14, 2013 14, 2015

Nov Jun

14, 2022 08, 2018

DS

DP DP

NCE ODE

Nov Nov

14, 2013 14, 2015

Aug

17, 2020

DS

DP

NCE ODE U-1201

Nov Nov

14, 2013 14, 2015

RUXOLITINIB PHOSPHATE - JAKAFI N202192 001 7598257 Dec RUXOLITINIB PHOSPHATE - JAKAFI N202192 002 7598257 Dec RUXOLITINIB PHOSPHATE - JAKAFI N202192 003 7598257 Dec RUXOLITINIB PHOSPHATE - JAKAFI N202192 004 7598257 Dec RUXOLITINIB PHOSPHATE - JAKAFI N202192 005 7598257 Dec

24, 2027

DS

DP

NCE ODE

Nov Nov

16, 2016 16, 2018

24, 2027

DS

DP

U-1201

NCE ODE

Nov Nov

16, 2016 16, 2018

24, 2027

DS

DP

U-1201

NCE ODE

Nov Nov

16, 2016 16, 2018

24, 2027

DS

DP

U-1201

NCE ODE

Nov Nov

16, 2016 16, 2018

24, 2027

DS

DP

U-1201

NCE ODE

Nov Nov

16, 2016 16, 2018

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 177 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)

SALMETEROL XINAFOATE - SEREVENT Sep N020692 001 5590645*PED Sep 5860419*PED Feb 5873360 Aug 5873360*PED Sep 6032666*PED Sep 6378519*PED Sep 6536427*PED Sep 6792945*PED Sep 7225808*PED Sep 7389775*PED

01, 01, 23, 23, 01, 01, 01, 01, 01, 01,

2011 2011 2016 2016 2011 2011 2011 2011 2011 2011

DP

SAPROPTERIN DIHYDROCHLORIDE - KUVAN N022181 001 7566462 Nov 16, 2025 7566714 Nov 17, 2024 7612073 Nov 17, 2024 7727987 Nov 17, 2024 7947681 Nov 17, 2024 8003126 Nov 16, 2025 8067416 Nov 17, 2024 SAQUINAVIR - FORTOVASE N020828 001 6008228 6008228*PED 6352717 6352717*PED

DP U-989 U-1010 DP U-1156 U-989

NCE ODE

Dec Dec

13, 2012 13, 2014

Jun Dec Nov May

06, 06, 16, 16,

2015 2015 2019 2020

SAXAGLIPTIN HYDROCHLORIDE - ONGLYZA N022350 001 6395767 Feb 16, 2021 7951400 Nov 30, 2028 SAXAGLIPTIN HYDROCHLORIDE - ONGLYZA N022350 002 6395767 Feb 16, 2021 7951400 Nov 30, 2028 SELEGILINE - EMSAM N021336 001 7070808 7150881 7638140 SELEGILINE - EMSAM N021336 002 7070808 7150881 7638140 SELEGILINE - EMSAM N021336 003 7070808 7150881 7638140

DS

DP DP

U-995

M-108 NCE

Dec Jul

16, 2013 31, 2014

DS

DP DP

U-995

M-108 NCE

Dec Jul

16, 2013 31, 2014

May Jun May

10, 2018 12, 2018 10, 2018

DS DS

DP DP DP

May Jun May

10, 2018 12, 2018 10, 2018

DS DS

DP DP DP

May Jun May

10, 2018 12, 2018 10, 2018

DS DS

DP DP DP

SELEGILINE HYDROCHLORIDE - ZELAPAR N021479 001 5648093 Jul 6423342 Mar SERTACONAZOLE NITRATE - ERTACZO N021385 001 5135943 May SERTRALINE HYDROCHLORIDE - ZOLOFT Aug N019839 001 5248699 Feb 5248699*PED SERTRALINE HYDROCHLORIDE - ZOLOFT Aug N019839 002 5248699 Feb 5248699*PED SERTRALINE HYDROCHLORIDE - ZOLOFT Aug N019839 003 5248699 Feb 5248699*PED

15, 2014 01, 2016

DP DP

31, 2014

DS

DP

U-786

13, 2012 13, 2013

13, 2012 13, 2013

13, 2012 13, 2013

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 178 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)

SERTRALINE HYDROCHLORIDE - ZOLOFT Aug N019839 004 5248699 Feb 5248699*PED SERTRALINE HYDROCHLORIDE - ZOLOFT Aug N019839 005 5248699 Feb 5248699*PED SERTRALINE HYDROCHLORIDE - ZOLOFT Aug N020990 001 5248699 Feb 5248699*PED Oct 6727283 Apr 6727283*PED Nov 7067555 May 7067555*PED SEVELAMER CARBONATE - RENVELA N022127 001 5496545 5667775 6509013 6858203 7014846 7459151 7985418 SEVELAMER CARBONATE - RENVELA N022318 001 5496545 5667775 6509013 6858203 7014846 7459151 SEVELAMER CARBONATE - RENVELA N022318 002 5496545 5667775 6509013 6858203 7014846 7459151

13, 2012 13, 2013

13, 2012 13, 2013

13, 13, 11, 11, 10, 10,

2012 2013 2019 2020 2019 2020

DP DP

U-580

Aug Sep Aug Aug Aug Aug Oct

11, 16, 11, 11, 11, 11, 27,

2013 2014 2013 2013 2013 2013 2025

DP DP DP DP DP

U-246 U-246 U-246 U-246 U-246

Aug Sep Aug Aug Aug Aug

11, 16, 11, 11, 11, 11,

2013 2014 2013 2013 2013 2013

DP DP DP DP

U-246 U-246 U-246 U-246 U-246

NDF

Aug

12, 2012

Aug Sep Aug Aug Aug Aug

11, 16, 11, 11, 11, 11,

2013 2014 2013 2013 2013 2013

DP DP DP DP

U-246 U-246 U-246 U-246 U-246

NDF

Aug

12, 2012

SEVELAMER HYDROCHLORIDE - RENAGEL N020926 001 5496545 Aug 5667775 Sep 6509013 Aug SEVELAMER HYDROCHLORIDE - RENAGEL N021179 001 5496545 Aug Sep 5667775 Aug 6509013 Oct 6733780 Aug 7014846 Aug 7459151 SEVELAMER HYDROCHLORIDE - RENAGEL Aug N021179 002 5496545 Sep 5667775 Aug 6509013 Oct 6733780 Aug 7014846 Aug 7459151

11, 2013 16, 2014 11, 2013

U-246 U-246

11, 16, 11, 18, 11, 11,

2013 2014 2013 2020 2013 2013

U-246 U-246 DP DP

U-246 U-246

11, 16, 11, 18, 11, 11,

2013 2014 2013 2020 2013 2013

U-246 U-246 DP DP

U-246 U-246

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 179 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)

SEVOFLURANE - ULTANE N020478 001 5990176 5990176*PED 6074668 6074668*PED 6288127 6288127*PED 6444859 6444859*PED

Jan Jul Jan Jul Jan Jul Jan Jul

27, 27, 09, 09, 27, 27, 27, 27,

2017 2017 2018 2018 2017 2017 2017 2017

SIBUTRAMINE HYDROCHLORIDE - MERIDIA N020632 001 5436272 Jul 25, 2012 5436272*PED Jan 25, 2013 SIBUTRAMINE HYDROCHLORIDE - MERIDIA N020632 002 5436272 Jul 25, 2012 5436272*PED Jan 25, 2013 SIBUTRAMINE HYDROCHLORIDE - MERIDIA N020632 003 5436272 Jul 25, 2012 5436272*PED Jan 25, 2013 SILDENAFIL CITRATE - REVATIO N021845 001 5250534 SILDENAFIL CITRATE - REVATIO N022473 001 5250534 SILDENAFIL CITRATE - VIAGRA N020895 001 5250534 6469012 SILDENAFIL CITRATE - VIAGRA N020895 002 5250534 6469012 SILDENAFIL CITRATE - VIAGRA N020895 003 5250534 6469012 SILODOSIN - RAPAFLO N022206 001 5387603 5403847 5780485 6015819 SILODOSIN - RAPAFLO N022206 002 5387603 5403847 5780485 6015819

U-439

U-439

U-439

Mar

27, 2012

DS

DP

I-598

May

07, 2012

Mar

27, 2012

DS

DP

NDF

Nov

20, 2012

Mar Oct

27, 2012 22, 2019

U-155

Mar Oct

27, 2012 22, 2019

U-155

Mar Oct

27, 2012 22, 2019

U-155

Dec Nov Nov Nov

01, 13, 13, 13,

2018 2012 2012 2012

DS

DP U-902 U-902 U-902

NCE

Oct

08, 2013

Dec Nov Nov Nov

01, 13, 13, 13,

2018 2012 2012 2012

DS

DP U-902 U-902 U-902

NCE

Oct

08, 2013

SIMVASTATIN; SITAGLIPTIN PHOSPHATE - JUVISYNC Apr 24, 2017 N202343 001 6303661 Jul 26, 2022 6699871 Feb 02, 2019 6890898 Feb 02, 2019 6890898 Feb 02, 2019 6890898 Feb 02, 2019 7078381 Jul 26, 2022 7125873 Jul 26, 2022 7125873 Jul 26, 2022 7125873 Jul 26, 2022 7125873 Apr 11, 2026 7326708 Feb 02, 2019 7459428

U-1188 DS DP U-1190 U-1189 U-1191 U-1188 U-1190 U-1189 U-1192 U-1193 U-1188 U-1189

DS

DP DP DP DP DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 180 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-1188 DS DP U-1190 U-1189 U-1191 U-1188 U-1193 U-1190 U-1192 U-1189 U-1188 U-1189

EXCLUSIVITY CODE(S)

SIMVASTATIN; SITAGLIPTIN PHOSPHATE - JUVISYNC N202343 002 6303661 Apr 24, 2017 6699871 Jul 26, 2022 6890898 Feb 02, 2019 6890898 Feb 02, 2019 6890898 Feb 02, 2019 7078381 Feb 02, 2019 7125873 Jul 26, 2022 7125873 Jul 26, 2022 7125873 Jul 26, 2022 7125873 Jul 26, 2022 7326708 Apr 11, 2026 Feb 02, 2019 7459428 SIMVASTATIN; SITAGLIPTIN PHOSPHATE - JUVISYNC N202343 003 6303661 Apr 24, 2017 6699871 Jul 26, 2022 6890898 Feb 02, 2019 6890898 Feb 02, 2019 6890898 Feb 02, 2019 7078381 Feb 02, 2019 7125873 Jul 26, 2022 7125873 Jul 26, 2022 7125873 Jul 26, 2022 7125873 Jul 26, 2022 7326708 Apr 11, 2026 Feb 02, 2019 7459428 SINCALIDE - KINEVAC N017697 001 6803046 SINECATECHINS - VEREGEN N021902 001 5795911 5968973 7858662 SIROLIMUS - RAPAMUNE N021083 001 5100899 5100899*PED 5403833 5403833*PED 5536729 5536729*PED SIROLIMUS - RAPAMUNE N021110 001 5100899 5100899*PED 5145684*PED 5403833 5403833*PED 5989591 5989591*PED SIROLIMUS - RAPAMUNE N021110 002 5100899 5100899*PED 5145684*PED 5403833 5403833*PED 5989591 5989591*PED SIROLIMUS - RAPAMUNE N021110 003 5100899 5100899*PED 5145684*PED 5403833 5403833*PED 5989591 5989591*PED

DS

DP DP DP DP DP

U-1188 DS DP U-1190 U-1191 U-1189 U-1188 U-1192 U-1189 U-1193 U-1190 U-1188 U-1189

DS

DP DP DP DP DP

Aug

16, 2022

DP

Oct Apr Oct

31, 2020 10, 2017 02, 2026

DP

U-172 U-172 U-172

Jul Jan Apr Oct Sep Mar

07, 07, 04, 04, 30, 30,

2013 2014 2012 2012 2013 2014

U-290 U-293 DP

Jul Jan Jul Apr Oct Mar Sep

07, 07, 25, 04, 04, 11, 11,

2013 2014 2011 2012 2012 2018 2018

U-290

U-293 DP

Jul Jan Jul Apr Oct Mar Sep

07, 07, 25, 04, 04, 11, 11,

2013 2014 2011 2012 2012 2018 2018

U-290

U-293 DP

Jul Jan Jul Apr Oct Mar Sep

07, 07, 25, 04, 04, 11, 11,

2013 2014 2011 2012 2012 2018 2018

U-290

U-293 DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 181 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-290

EXCLUSIVITY CODE(S)

SIROLIMUS - RAPAMUNE N021110 004 5100899 5100899*PED 5145684*PED 5403833 5403833*PED 5989591 5989591*PED

Jul Jan Jul Apr Oct Mar Sep

07, 07, 25, 04, 04, 11, 11,

2013 2014 2011 2012 2012 2018 2018

U-293 DP

SITAGLIPTIN PHOSPHATE - JANUVIA N021995 001 6303661 Apr 6699871 Jul 6890898 Feb 6890898 Feb 6890898 Feb 7078381 Feb 7078381 Feb 7078381 Feb 7078381 Feb 7125873 Jul 7125873 Jul 7125873 Jul 7125873 Jul 7326708 Apr SITAGLIPTIN PHOSPHATE - JANUVIA N021995 002 6303661 Apr 6699871 Jul 6890898 Feb 6890898 Feb 6890898 Feb 7078381 Feb 7078381 Feb 7078381 Feb 7078381 Feb 7125873 Jul 7125873 Jul 7125873 Jul 7125873 Jul 7326708 Apr SITAGLIPTIN PHOSPHATE - JANUVIA N021995 003 6303661 Apr 6699871 Jul 6890898 Feb 6890898 Feb 6890898 Feb 7078381 Feb 7078381 Feb 7078381 Feb 7078381 Feb 7125873 Jul 7125873 Jul 7125873 Jul 7125873 Jul 7326708 Apr

24, 26, 02, 02, 02, 02, 02, 02, 02, 26, 26, 26, 26, 11,

2017 2022 2019 2019 2019 2019 2019 2019 2019 2022 2022 2022 2022 2026

DS

DP

DS

DP

U-774 U-774 U-775 U-1039 U-1036 U-775 U-1036 U-1037 U-1038 U-775 U-1036 U-1037 U-1038 U-802

NCE

Oct

16, 2011

24, 26, 02, 02, 02, 02, 02, 02, 02, 26, 26, 26, 26, 11,

2017 2022 2019 2019 2019 2019 2019 2019 2019 2022 2022 2022 2022 2026

DS

DP

DS

DP

U-774 U-774 U-1039 U-1036 U-775 U-775 U-1038 U-1037 U-1036 U-1038 U-1036 U-1037 U-775 U-802

NCE

Oct

16, 2011

24, 26, 02, 02, 02, 02, 02, 02, 02, 26, 26, 26, 26, 11,

2017 2022 2019 2019 2019 2019 2019 2019 2019 2022 2022 2022 2022 2026

DS

DP

DS

DP

U-774 U-774 U-1039 U-1036 U-775 U-1037 U-1036 U-1038 U-775 U-1037 U-1038 U-1036 U-775 U-802

NCE

Oct

16, 2011

SODIUM BENZOATE; SODIUM PHENYLACETATE - AMMONUL N020645 001 SODIUM NITRITE; SODIUM THIOSULFATE - NITHIODOTE N201444 001

ODE

Feb

17, 2012

ODE

Jan

14, 2018

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 182 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DP DP U-1110 U-1069 U-1070 U-1102 U-1101 U-1110

EXCLUSIVITY CODE(S)
ODE

SODIUM OXYBATE - XYREM N021196 001 6780889 7262219 7668730 7765106 7765107 7851506 7851506 7895059

Jul Jul Jun Jun Jun Dec Dec Dec

04, 04, 16, 16, 16, 22, 22, 17,

2020 2020 2024 2024 2024 2019 2019 2022

Nov

18, 2012

SODIUM PHOSPHATE, DIBASIC ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE - VISICOL N021097 001 5616346 May 18, 2013 U-359 SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE - OSMOPREP N021892 001 5616346 May 18, 2013 DP U-715

7687075 Jun 22, 2028
DS DP
SOLIFENACIN SUCCINATE - VESICARE N021518 001 6017927 Nov SOLIFENACIN SUCCINATE - VESICARE N021518 002 6017927 Nov

19, 2018

DS

DP

19, 2018

DS

DP

SOMATROPIN RECOMBINANT - GENOTROPIN PRESERVATIVE FREE N020280 001 5435076 Apr 16, 2013 DP DP 5501673 Apr 16, 2013 DP 5716338 Feb 10, 2015 DP 6152897 Nov 20, 2018 SOMATROPIN RECOMBINANT - GENOTROPIN PRESERVATIVE FREE N020280 002 5435076 Apr 16, 2013 DP DP 5501673 Apr 16, 2013 DP 5716338 Feb 10, 2015 6152897 Nov 20, 2018 DP SOMATROPIN RECOMBINANT - GENOTROPIN PRESERVATIVE FREE N020280 003 5435076 Apr 16, 2013 DP DP 5501673 Apr 16, 2013 5716338 Feb 10, 2015 DP DP 6152897 Nov 20, 2018 SOMATROPIN RECOMBINANT - GENOTROPIN PRESERVATIVE FREE N020280 005 5435076 Apr 16, 2013 DP 5501673 Apr 16, 2013 DP DP 5716338 Feb 10, 2015 DP 6152897 Nov 20, 2018 SOMATROPIN RECOMBINANT - GENOTROPIN PRESERVATIVE FREE N020280 008 5435076 Apr 16, 2013 DP DP 5501673 Apr 16, 2013 DP 5716338 Feb 10, 2015 DP 6152897 Nov 20, 2018 SOMATROPIN RECOMBINANT - GENOTROPIN PRESERVATIVE FREE N020280 009 5435076 Apr 16, 2013 DP DP 5501673 Apr 16, 2013 DP 5716338 Feb 10, 2015 6152897 Nov 20, 2018 DP SOMATROPIN RECOMBINANT - GENOTROPIN PRESERVATIVE FREE N020280 010 5435076 Apr 16, 2013 DP 5501673 Apr 16, 2013 DP DP 5716338 Feb 10, 2015 SOMATROPIN RECOMBINANT - GENOTROPIN PRESERVATIVE FREE N020280 011 5435076 Apr 16, 2013 DP 5501673 Apr 16, 2013 DP DP 5716338 Feb 10, 2015

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 183 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)

SOMATROPIN RECOMBINANT - GENOTROPIN PRESERVATIVE FREE DP N020280 012 5435076 Apr 16, 2013 DP 5501673 Apr 16, 2013 DP Feb 10, 2015 5716338 SOMATROPIN RECOMBINANT - GENOTROPIN PRESERVATIVE FREE N020280 013 5435076 Apr 16, 2013 DP DP 5501673 Apr 16, 2013 DP 5716338 Feb 10, 2015 SOMATROPIN RECOMBINANT - HUMATROPE N019640 001 SOMATROPIN RECOMBINANT - HUMATROPE N019640 004 SOMATROPIN RECOMBINANT - HUMATROPE N019640 005 SOMATROPIN RECOMBINANT - HUMATROPE N019640 006 SOMATROPIN RECOMBINANT - HUMATROPE N019640 007 SOMATROPIN RECOMBINANT - NORDITROPIN N021148 001 5849700 Dec 15, 2015 5849704 Dec 15, 2015 SOMATROPIN RECOMBINANT - NORDITROPIN N021148 002 5849700 Dec 15, 2015 5849704 Dec 15, 2015 SOMATROPIN RECOMBINANT - NORDITROPIN N021148 003 5633352 May 27, 2014 Dec 15, 2015 5849700 Dec 15, 2015 5849704 SOMATROPIN RECOMBINANT - NORDITROPIN FLEXPRO N021148 008 5849700 Dec 15, 2015 5849704 Dec 15, 2015 SOMATROPIN RECOMBINANT - NORDITROPIN FLEXPRO N021148 009 5849700 Dec 15, 2015 5849704 Dec 15, 2015 SOMATROPIN RECOMBINANT - NORDITROPIN FLEXPRO N021148 010 5849700 Dec 15, 2015 5849704 Dec 15, 2015 SOMATROPIN RECOMBINANT - NORDITROPIN NORDIFLEX N021148 004 5849700 Dec 15, 2015 5849704 Dec 15, 2015 SOMATROPIN RECOMBINANT - NORDITROPIN NORDIFLEX N021148 005 5849700 Dec 15, 2015 5849704 Dec 15, 2015 SOMATROPIN RECOMBINANT - NORDITROPIN NORDIFLEX N021148 006 5849700 Dec 15, 2015 5849704 Dec 15, 2015

I-585 ODE

Mar Nov

12, 2012 01, 2013

I-585 ODE

Mar Nov

12, 2012 01, 2013

I-585 ODE

Mar Nov

12, 2012 01, 2013

I-585 ODE

Mar Nov

12, 2012 01, 2013

I-585 ODE U-340

Mar Nov

12, 2012 01, 2013

I-572 ODE

Oct May

31, 2011 31, 2014

U-340

I-572 ODE

Oct May

31, 2011 31, 2014

U-340

I-572 ODE

Oct May

31, 2011 31, 2014

DP

U-1041 U-1041

I-572 ODE

Oct May

31, 2011 31, 2014

DP

U-1041 U-1041

I-572 ODE

Oct May

31, 2011 31, 2014

DP

U-1041 U-1041

I-572 ODE

Oct May

31, 2011 31, 2014

DP

U-340 U-340

I-572 ODE

Oct May

31, 2011 31, 2014

DP

U-340 U-340

I-572 ODE

Oct May

31, 2011 31, 2014

DP

U-340 U-340

I-572 ODE

Oct May

31, 2011 31, 2014

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 184 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-340 U-340

EXCLUSIVITY CODE(S)
I-572 ODE

SOMATROPIN RECOMBINANT - NORDITROPIN NORDIFLEX N021148 007 5849700 Dec 15, 2015 5849704 Dec 15, 2015 SOMATROPIN RECOMBINANT - NUTROPIN AQ N020522 001 5763394 Jun 09, 2015 SOMATROPIN RECOMBINANT - NUTROPIN AQ PEN N020522 002 5763394 Jun 09, 2015 SOMATROPIN RECOMBINANT - NUTROPIN DEPOT N021075 001 5654010 Aug 05, 5656297 Jul 25, 5912015 Mar 12, 6051259 Dec 02, SOMATROPIN RECOMBINANT - NUTROPIN DEPOT N021075 002 5654010 Aug 05, 5656297 Jul 25, 5912015 Mar 12, 6051259 Dec 02, SOMATROPIN RECOMBINANT - NUTROPIN DEPOT Aug 05, N021075 003 5654010 Jul 25, 5656297 Mar 12, 5912015 Dec 02, 6051259 SOMATROPIN RECOMBINANT - SAIZEN N019764 002 5898030 Apr SOMATROPIN RECOMBINANT - SAIZEN Apr N019764 003 5898030 SOMATROPIN RECOMBINANT - SEROSTIM Apr N020604 001 5898030 SOMATROPIN RECOMBINANT - SEROSTIM Apr N020604 002 5898030 SOMATROPIN RECOMBINANT - SEROSTIM Apr N020604 003 5898030 SOMATROPIN RECOMBINANT - SEROSTIM Apr N020604 004 5898030 SOMATROPIN RECOMBINANT - ZORBTIVE Oct N021597 004 5288703 Apr 5898030 SORAFENIB TOSYLATE - NEXAVAR N021923 001 7235576 7351834 7897623

DP

Oct May

31, 2011 31, 2014

DP

DP

2014 2014 2012 2012

U-340

2014 2014 2012 2012

U-340

2014 2014 2012 2012

U-340

27, 2016

DP

27, 2016

DP

27, 2016

DP

27, 2016

DP

27, 2016

DP

27, 2016

DP

07, 2011 27, 2016

U-898 DP

Jan Jan Jan

12, 2020 12, 2020 12, 2020

DS DS

DP DP

ODE ODE

Nov Dec

16, 2014 20, 2012

SOTALOL HYDROCHLORIDE - SOTALOL HYDROCHLORIDE N022306 001 SPINOSAD - NATROBA N022408 001 5496931 6063771 6342482 7030095 STAVUDINE - ZERIT XR N021453 001 7135465 7135465*PED

ODE DS DP DP DP U-1105 U-1105 U-1105 U-1105

Jul

02, 2016

Mar Jun Jun Jul

05, 22, 22, 02,

2013 2019 2019 2021

NCE

Jan

18, 2016

Feb Aug

18, 2023 18, 2023

DP

U-167

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 185 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DP U-167

EXCLUSIVITY CODE(S)

STAVUDINE - ZERIT XR N021453 002 7135465 7135465*PED STAVUDINE - ZERIT XR N021453 003 7135465 7135465*PED STAVUDINE - ZERIT XR N021453 004 7135465 7135465*PED SUMATRIPTAN - IMITREX N020626 001 5307953 5307953*PED 5554639 5554639*PED 5705520 5705520*PED SUMATRIPTAN - IMITREX N020626 002 5307953 5307953*PED 5554639 5554639*PED 5705520 5705520*PED SUMATRIPTAN - IMITREX N020626 003 5307953 5307953*PED 5554639 5554639*PED 5705520 5705520*PED

Feb Aug

18, 2023 18, 2023

Feb Aug

18, 2023 18, 2023

DP

U-167

Feb Aug

18, 2023 18, 2023

DP

U-167

Dec Jun Sep Mar Dec Jun

02, 02, 10, 10, 10, 10,

2012 2013 2013 2014 2011 2012

U-232 U-232

Dec Jun Sep Mar Dec Jun

02, 02, 10, 10, 10, 10,

2012 2013 2013 2014 2011 2012

U-232 U-232

Dec Jun Sep Mar Dec Jun

02, 02, 10, 10, 10, 10,

2012 2013 2013 2014 2011 2012

U-232 U-232

SUMATRIPTAN SUCCINATE - ALSUMA N022377 001 7811254 Aug

26, 2027

DP

U-1083

SUMATRIPTAN SUCCINATE - SUMAVEL DOSEPRO N022239 001 5891086 Jul 27, 5957886 Mar 08, 6135979 Mar 21, 7776007 Nov 28, 7901385 Jul 31, SUNITINIB MALATE - SUTENT N021938 001 6573293 7125905 7211600 SUNITINIB MALATE - SUTENT N021938 002 6573293 7125905 7211600 SUNITINIB MALATE - SUTENT N021938 003 6573293 7125905 7211600 SUNITINIB MALATE - SUTENT N021938 004 6573293 7125905 7211600 TACROLIMUS - PROGRAF N050708 001 TACROLIMUS - PROGRAF N050708 002

2014 2016 2017 2026 2026

DP DP DP DP DP

Feb Feb Dec

15, 2021 15, 2021 22, 2020

DS DS

DP DP

U-1154 U-883

I-639

May

20, 2014

Feb Feb Dec

15, 2021 15, 2021 22, 2020

DS DS

DP DP

U-1154 U-883

I-639

May

20, 2014

Feb Feb Dec

15, 2021 15, 2021 22, 2020

DS DS

DP DP

U-1154 U-883

I-639

May

20, 2014

Feb Feb Dec

15, 2021 15, 2021 22, 2020

DS DS

DP DP

U-1154 U-883

I-639

May

20, 2014

ODE

Mar

29, 2013

ODE

Mar

29, 2013

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 186 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)
ODE

TACROLIMUS - PROGRAF N050708 003 TACROLIMUS - PROGRAF N050709 001 TACROLIMUS - PROTOPIC N050777 001 5385907 5665727 TACROLIMUS - PROTOPIC N050777 002 5385907 5665727 TADALAFIL - ADCIRCA N022332 001 5859006 6821975 7182958 TADALAFIL - CIALIS N021368 001 5859006 6140329 6140329 6821975 6821975 6821975 6943166 6943166 6943166 7182958 7182958 TADALAFIL - CIALIS N021368 002 5859006 6140329 6821975 6821975 6943166 6943166 7182958 TADALAFIL - CIALIS N021368 003 5859006 6140329 6821975 6821975 6943166 7182958 TADALAFIL - CIALIS N021368 004 5859006 6140329 6821975 6821975 6943166 7182958 TAMOXIFEN CITRATE - SOLTAMOX N021807 001 6127425

Mar

29, 2013

ODE Jan Sep 31, 2012 09, 2014 DP U-919

Mar

29, 2013

Jan Sep

31, 2012 09, 2014

DP U-919

Nov Nov Apr

21, 2017 19, 2020 26, 2020

DS DS

DP DP DP

U-975

NP ODE

May May

22, 2012 22, 2016

Nov Jul Jul Nov Nov Nov Apr Apr Apr Apr Apr

21, 11, 11, 19, 19, 19, 26, 26, 26, 26, 26,

2017 2016 2016 2020 2020 2020 2020 2020 2020 2020 2020

DS

DS DS DS

DP DP DP DP DP DP

DP DP

U-155 U-1184 U-533 U-614 U-1184 U-155 U-1184 U-614 U-1184 U-155

I-642 I-641

Oct Oct

07, 2014 07, 2014

Nov Jul Nov Nov Apr Apr Apr

21, 11, 19, 19, 26, 26, 26,

2017 2016 2020 2020 2020 2020 2020

DS DS DS

DP DP DP DP

DP

U-155 U-614 U-533 U-155 U-614 U-155

I-642 I-641

Oct Oct

07, 2014 07, 2014

Nov Jul Nov Nov Apr Apr

21, 11, 19, 19, 26, 26,

2017 2016 2020 2020 2020 2020

DS DS DS

DP DP DP DP DP

U-155 U-533 U-614 U-614 U-155

I-642 I-641

Oct Oct

07, 2014 07, 2014

Nov Jul Nov Nov Apr Apr

21, 11, 19, 19, 26, 26,

2017 2016 2020 2020 2020 2020

DS DS DS

DP DP DP DP DP

U-155 U-614 U-533 U-155 U-155

I-642 I-641

Oct Oct

07, 2014 07, 2014

Jun

26, 2018

DP

TAMSULOSIN HYDROCHLORIDE - FLOMAX N020579 001 TAPENTADOL HYDROCHLORIDE - NUCYNTA N022304 001 6071970 Jun 7994364 Jun RE39593 Aug

M-54 PED 06, 2017 27, 2025 05, 2022 U-931 U-931 U-931

Dec Jun

22, 2012 22, 2013

NCE

Nov

20, 2013

DS DS

DP DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 187 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-931 U-931 U-931

EXCLUSIVITY CODE(S)
NCE

TAPENTADOL HYDROCHLORIDE - NUCYNTA N022304 002 6071970 Jun 7994364 Jun RE39593 Aug TAPENTADOL HYDROCHLORIDE - NUCYNTA N022304 003 6071970 Jun 7994364 Jun RE39593 Aug

06, 2017 27, 2025 05, 2022

Nov

20, 2013

DS DS

DP DP

06, 2017 27, 2025 05, 2022

DS DS

DP DP

U-931 U-931 U-931

NCE

Nov

20, 2013

TAPENTADOL HYDROCHLORIDE - NUCYNTA ER N200533 001 6071970 Jun 06, 7994364 Jun 27, 8075872 Nov 20, RE39593 Aug 05, TAPENTADOL HYDROCHLORIDE - NUCYNTA ER N200533 002 6071970 Jun 06, 7994364 Jun 27, 8075872 Nov 20, RE39593 Aug 05, TAPENTADOL HYDROCHLORIDE - NUCYNTA ER N200533 003 6071970 Jun 06, 7994364 Jun 27, 8075872 Nov 20, RE39593 Aug 05, TAPENTADOL HYDROCHLORIDE - NUCYNTA ER N200533 004 6071970 Jun 06, 7994364 Jun 27, 8075872 Nov 20, RE39593 Aug 05, TAPENTADOL HYDROCHLORIDE - NUCYNTA ER N200533 005 6071970 Jun 06, 7994364 Jun 27, 8075872 Nov 20, RE39593 Aug 05, TAZAROTENE - TAZORAC N020600 001 5914334 6258830 TAZAROTENE - TAZORAC N020600 002 5914334 6258830

2017 2025 2023 2022

DS DS

DP DP DP

U-1178 U-1178 U-1178

NDF NCE

Aug Nov

25, 2014 20, 2013

2017 2025 2023 2022

DS DS

DP DP DP

U-1178 U-1178 U-1178

NDF NCE

Aug Nov

25, 2014 20, 2013

2017 2025 2023 2022

DS DS

DP DP DP

U-1178 U-1178 U-1178

NDF NCE

Aug Nov

25, 2014 20, 2013

2017 2025 2023 2022

DS DS

DP DP DP

U-1178 U-1178 U-1178

NDF NCE

Aug Nov

25, 2014 20, 2013

2017 2025 2023 2022

DS DS

DP DP DP

U-1178 U-1178 U-1178

NDF NCE

Aug Nov

25, 2014 20, 2013

Jun Jun

07, 2014 07, 2014

U-517 U-517

Jun Jun

07, 2014 07, 2014

U-517 U-517

TECHNETIUM TC-99M APCITIDE - ACUTECT N020887 001 5443815 Aug 22, 2012 5508020 Apr 16, 2013 5645815 Jul 08, 2014 TECHNETIUM TC-99M BICISATE KIT - NEUROLITE N020256 001 5431900 Jul 11, 2012 TECHNETIUM TC-99M MERTIATIDE KIT - TECHNESCAN MAG3 N019882 001 5573748 Nov 12, 2013 TECHNETIUM TC-99M SESTAMIBI KIT - CARDIOLITE N019785 001 TECHNETIUM TC-99M TEBOROXIME KIT - CARDIOTEC N019928 001 6056941 Jul 28, 2019 TEGASEROD MALEATE - ZELNORM N021200 001 5510353 TEGASEROD MALEATE - ZELNORM N021200 002 5510353

U-336

DP

PED DP

Oct

30, 2011

Apr

26, 2013

U-466

Apr

26, 2013

U-466

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 188 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DS DP

EXCLUSIVITY CODE(S)
NCE

TELAPREVIR - INCIVEK N201917 001 7820671

Feb

25, 2025

May

23, 2016

TELAVANCIN HYDROCHLORIDE - VIBATIV Sep N022110 001 6635618 Aug 6858584 Jun 6872701 May 7008923 May 7208471 May 7351691 Jan 7531623 May 7544364 May 7700550 TELAVANCIN HYDROCHLORIDE - VIBATIV Sep N022110 002 6635618 Aug 6858584 Jun 6872701 May 7008923 May 7208471 May 7351691 Jan 7531623 May 7544364 May 7700550 TELBIVUDINE - TYZEKA N022011 001 6395716 6444652 6566344 6569837 6569837 7589079 7795238 7858594 TELBIVUDINE - TYZEKA N022154 001 6395716 6444652 6566344 6569837 7795238 TELITHROMYCIN - KETEK N021144 001 5635485 D459798 TELITHROMYCIN - KETEK N021144 002 5635485 D459798 TELMISARTAN - MICARDIS N020850 001 5591762 6358986 TELMISARTAN - MICARDIS N020850 002 5591762 6358986 7998953 8003679 TELMISARTAN - MICARDIS N020850 003 5591762 6358986 TEMOZOLOMIDE - TEMODAR N021029 001 5260291 5260291*PED

22, 24, 05, 06, 01, 01, 01, 01, 01,

2021 2022 2021 2021 2021 2021 2027 2021 2021

DS

DP DP DP DP DP DP

U-728

NCE

Sep

11, 2014

U-1005 DS DS DS U-728

U-282

22, 24, 05, 06, 01, 01, 01, 01, 01,

2021 2022 2021 2021 2021 2021 2027 2021 2021

DS

DP DP DP DP DP DP

U-728

NCE

Sep

11, 2014

U-1005 DS DS DS U-728

U-282

Aug Aug Aug Oct Oct Sep Aug Sep

10, 10, 10, 25, 25, 11, 10, 11,

2019 2019 2019 2020 2020 2023 2019 2023

DS DS

DP DP

U-782 U-782 U-782 U-999 U-782 U-999 U-999 U-999

NCE

Oct

25, 2011

Aug Aug Aug Oct Aug

10, 10, 10, 25, 10,

2019 2019 2019 2020 2019

U-999 U-999 U-999 U-999 U-999

NCE

Oct

25, 2011

Apr Sep

01, 2018 24, 2015

DS

DP DP

U-578

Apr Sep

01, 2018 24, 2015

DS

DP DP

U-578

Jan Jan

07, 2014 10, 2020

U-3

Jan Jan Jun Oct

07, 10, 06, 06,

2014 2020 2020 2022

DS

DP

U-3 U-1177 U-1176

I-612

Oct

16, 2012

Jan Jan

07, 2014 10, 2020

U-3

Aug Feb

11, 2013 11, 2014

DS

DP

U-619

ODE

Mar

15, 2012

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 189 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DS DP U-619

EXCLUSIVITY CODE(S)
ODE

TEMOZOLOMIDE - TEMODAR N021029 002 5260291 5260291*PED TEMOZOLOMIDE - TEMODAR N021029 003 5260291 5260291*PED TEMOZOLOMIDE - TEMODAR N021029 004 5260291 5260291*PED TEMOZOLOMIDE - TEMODAR N021029 005 5260291 5260291*PED TEMOZOLOMIDE - TEMODAR N021029 006 5260291 5260291*PED TEMOZOLOMIDE - TEMODAR N022277 001 5260291 5260291*PED 6987108 7786118 TEMSIROLIMUS - TORISEL N022088 001 5362718 8026276

Aug Feb

11, 2013 11, 2014

Mar

15, 2012

Aug Feb

11, 2013 11, 2014

DS

DP

U-619

ODE

Mar

15, 2012

Aug Feb

11, 2013 11, 2014

DS

DP

U-619

ODE

Mar

15, 2012

Aug Feb

11, 2013 11, 2014

DS

DP

U-619

ODE

Mar

15, 2012

Aug Feb

11, 2013 11, 2014

DS

DP

U-619

ODE

Mar

15, 2012

Aug Feb Sep Feb

11, 11, 08, 21,

2013 2014 2023 2023

DS

DP DP DP

U-619

Apr Jan

18, 2014 20, 2026

DS

DP DP

M-92 M-91 NCE ODE U-999 U-248 U-250 U-256

Jul Apr May May

09, 26, 30, 30,

2013 2013 2012 2014

TENOFOVIR DISOPROXIL FUMARATE - VIREAD N021356 001 5922695 Jul 25, 5922695 Jul 25, 5922695 Jul 25, 5922695 Jul 25, 5922695*PED Jan 25, 5935946 Jul 25, 5935946 Jul 25, 5935946 Jul 25, 5935946 Jul 25, 5935946*PED Jan 25, 5977089 Jul 25, 5977089 Jul 25, 5977089 Jul 25, 5977089 Jul 25, 5977089*PED Jan 25, 6043230 Jul 25, 6043230 Jul 25, 6043230 Jul 25, 6043230 Jul 25, 6043230*PED Jan 25, TERAZOSIN HYDROCHLORIDE - HYTRIN N019057 001 5294615 Apr 5294615 Apr 5412095 Apr TERAZOSIN HYDROCHLORIDE - HYTRIN Apr N019057 002 5294615 Apr 5294615 Apr 5412095 TERAZOSIN HYDROCHLORIDE - HYTRIN N019057 003 5294615 Apr 5294615 Apr 5412095 Apr

2017 2017 2017 2017 2018 2017 2017 2017 2017 2018 2017 2017 2017 2017 2018 2017 2017 2017 2017 2018

DS DS DS DS DS DS DS DS DS DS DS DS DP DP DP DP DP DP DP DP

U-250 U-999 U-256 U-248 U-250 U-248 U-256 U-999 U-250 U-256 U-999 U-248

I-569 M-95 NPP ODE PED PED PED PED

Aug Oct Mar Mar Feb Apr Sep Sep

11, 01, 24, 24, 11, 01, 24, 24,

2011 2013 2013 2017 2012 2014 2013 2017

29, 2013 29, 2013 29, 2013

U-3 U-165

29, 2013 29, 2013 29, 2013

U-165 U-3

29, 2013 29, 2013 29, 2013

U-165 U-3

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 190 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-3 U-165

EXCLUSIVITY CODE(S)

TERAZOSIN HYDROCHLORIDE - HYTRIN Apr N019057 004 5294615 Apr 5294615 Apr 5412095 TERAZOSIN HYDROCHLORIDE - HYTRIN N020347 001 5294615 Apr 5294615 Apr Apr 5412095 TERAZOSIN HYDROCHLORIDE - HYTRIN Apr N020347 002 5294615 Apr 5294615 Apr 5412095 TERAZOSIN HYDROCHLORIDE - HYTRIN N020347 003 5294615 Apr 5294615 Apr Apr 5412095 TERAZOSIN HYDROCHLORIDE - HYTRIN Apr N020347 004 5294615 Apr 5294615 Apr 5412095 TERBINAFINE - LAMISIL N020846 001 5681849 5681849*PED 5856355 5856355 5856355 5856355*PED 6005001 6005001 6005001 6005001*PED TERBINAFINE - LAMISIL AT N021958 001 5681849 5681849*PED 5856355 5856355 5856355*PED

29, 2013 29, 2013 29, 2013

29, 2013 29, 2013 29, 2013

U-165 U-3

29, 2013 29, 2013 29, 2013

U-165 U-3

29, 2013 29, 2013 29, 2013

U-3 U-165

29, 2013 29, 2013 29, 2013

U-3 U-165

Oct Apr May May May Nov May May May Nov

28, 28, 18, 18, 18, 18, 18, 18, 18, 18,

2014 2015 2012 2012 2012 2012 2012 2012 2012 2012

DP DP DP DP DP DP DP U-502 U-504 U-540 U-502 U-540 U-504

Oct Apr May May Nov

28, 28, 18, 18, 18,

2014 2015 2012 2012 2012

DP DP DP U-540 U-504

TERBINAFINE HYDROCHLORIDE - LAMISIL AT Oct 28, 2014 N021124 001 5681849 Apr 28, 2015 5681849*PED TERBINAFINE HYDROCHLORIDE - LAMISIL AT Oct 28, 2014 N021124 002 5681849 Apr 28, 2015 5681849*PED TERIPARATIDE RECOMBINANT HUMAN - FORTEO Dec 08, N021318 001 6770623 Aug 19, 6977077 Dec 08, 7144861 Aug 19, 7163684 Aug 19, 7351414 Dec 08, 7550434 TERIPARATIDE RECOMBINANT HUMAN - FORTEO N021318 002 6770623 Dec 08, 6977077 Aug 19, Aug 19, 6977077 Dec 08, 7144861 Aug 19, 7163684 Aug 19, 7163684 Aug 19, 7351414 Aug 19, 7351414 Dec 08, 7550434

2018 2019 2018 2019 2019 2018

DP DP

U-597 U-597 U-790 U-865 U-982

I-602

Jul

22, 2012

DP

2018 2019 2019 2018 2019 2019 2019 2019 2018

DP

U-982 U-994 U-982 U-983 U-994 U-984 U-994 U-982

I-602

Jul

22, 2012

DP

DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 191 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DS DS DP DP

EXCLUSIVITY CODE(S)
NCE

TESAMORELIN ACETATE - EGRIFTA

May N022505 001 5861379
May 6020311
Jul 7144577
Aug 7316997
TESTOSTERONE - ANDRODERM N020489 003 TESTOSTERONE - ANDRODERM N020489 004 TESTOSTERONE - ANDROGEL
N021015 001 6503894
6503894*PED
TESTOSTERONE - ANDROGEL
N021015 002 6503894
6503894*PED
TESTOSTERONE - ANDROGEL
N021015 003 6503894
6503894*PED
TESTOSTERONE - ANDROGEL
N022309 001 6503894
TESTOSTERONE - AXIRON
N022504 001 6299900
6818226
6923983
8071075
TESTOSTERONE - FORTESTA
N021463 001 6319913
6579865
TESTOSTERONE - STRIANT
N021543 001 6248358
TESTOSTERONE - TESTIM
N021454 001 7320968
7608605
7608606
7608607
7608608
7608609
7608610
7935690
8063029
TESTOSTERONE - TESTODERM
N019762 001 5840327
TESTOSTERONE - TESTODERM
N019762 002 5840327

26, 26, 14, 14,

2015 2015 2020 2023

U-1100 U-1100
U-1100
U-1100

Nov

10, 2015

NS

Oct

20, 2014

NS Aug Mar 30, 2020 01, 2021 U-490

Oct

20, 2014

Aug Mar

30, 2020 01, 2021

U-490

Aug Mar

30, 2020 01, 2021

U-490

Aug

30, 2020

U-1103

NP

Apr

29, 2014

Feb Feb Feb Feb

19, 19, 19, 19,

2017 2017 2017 2017

DP DP DP DP

U-1103 U-1103
U-1103
U-1103

NP

Nov

23, 2013

Nov Nov

09, 2018 09, 2018

U-490 DP

NP

Dec

29, 2013

Aug

23, 2019

U-527
U-843
U-1009 U-1009 U-1009 U-1009 U-1009 U-1009 U-1009 U-843

Jan Apr Apr Apr Apr Apr Apr Apr Apr

18, 21, 21, 21, 21, 21, 21, 21, 21,

2025 2023 2023 2023 2023 2023 2023 2023 2023

Aug

15, 2016

Aug

15, 2016

TESTOSTERONE - TESTODERM TTS

N020791 001 6348210
Nov TETRABENAZINE - XENAZINE N021894 001 TETRABENAZINE - XENAZINE N021894 002

10, 2019

U-440

NCE ODE

Aug Aug

15, 2013 15, 2015

NCE ODE

Aug Aug

15, 2013 15, 2015

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 192 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-731 U-731 U-371 U-731 U-731 U-442 U-731 U-371 U-371 U-731 U-371 U-731 U-371 U-731 U-732 U-733 U-731 U-371 U-731 U-371 U-733 U-732 DP U-899 U-1058 U-1109 U-442 U-371 U-732 U-733 U-1155

EXCLUSIVITY CODE(S)
ODE

THALIDOMIDE - THALOMID N020785 001 5629327 6045501 6045501 6235756 6315720 6315720 6561976 6561976 6561977 6561977 6755784 6755784 6869399 6869399 6869399 6869399 6908432 6908432 7141018 7141018 7141018 7141018 7230012 7435745 7723361 7874984 7874984 7874984 7874984 7874984 7959566 THALIDOMIDE - THALOMID N020785 002 5629327 6045501 6045501 6235756 6315720 6315720 6561976 6561976 6561977 6561977 6755784 6755784 6869399 6869399 6869399 6869399 6908432 6908432 7141018 7141018 7141018 7141018 7230012 7435745 7723361 7874984 7874984 7874984 7874984 7874984 7959566

May Aug Aug Mar Oct Oct Aug Aug Oct Oct Oct Oct Oct Oct Oct Oct Aug Aug Oct Oct Oct Oct Dec Nov Mar Aug Aug Aug Aug Aug Oct

13, 28, 28, 01, 23, 23, 28, 28, 23, 23, 23, 23, 23, 23, 23, 23, 28, 28, 23, 23, 23, 23, 09, 03, 01, 28, 28, 28, 28, 28, 23,

2014 2018 2018 2013 2020 2020 2018 2018 2020 2020 2020 2020 2020 2020 2020 2020 2018 2018 2020 2020 2020 2020 2023 2017 2013 2018 2018 2018 2018 2018 2020

May

25, 2013

May Aug Aug Mar Oct Oct Aug Aug Oct Oct Oct Oct Oct Oct Oct Oct Aug Aug Oct Oct Oct Oct Dec Nov Mar Aug Aug Aug Aug Aug Oct

13, 28, 28, 01, 23, 23, 28, 28, 23, 23, 23, 23, 23, 23, 23, 23, 28, 28, 23, 23, 23, 23, 09, 03, 01, 28, 28, 28, 28, 28, 23,

2014 2018 2018 2013 2020 2020 2018 2018 2020 2020 2020 2020 2020 2020 2020 2020 2018 2018 2020 2020 2020 2020 2023 2017 2013 2018 2018 2018 2018 2018 2020

U-731 U-371 U-731 U-731 U-731 U-442 U-731 U-371 U-371 U-731 U-731 U-371 U-732 U-731 U-371 U-733 U-371 U-731 U-732 U-733 U-731 U-371 DP U-899 U-1058 U-371 U-1109 U-732 U-733 U-442 U-1155

ODE

May

25, 2013

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 193 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-731 U-731 U-371 U-731 U-731 U-442 U-371 U-731 U-731 U-371 U-371 U-731 U-731 U-732 U-733 U-371 U-371 U-731 U-731 U-732 U-371 U-733 DP U-899 U-1058 U-371 U-442 U-733 U-732 U-1109 U-1155

EXCLUSIVITY CODE(S)
ODE

THALIDOMIDE - THALOMID N020785 003 5629327 6045501 6045501 6235756 6315720 6315720 6561976 6561976 6561977 6561977 6755784 6755784 6869399 6869399 6869399 6869399 6908432 6908432 7141018 7141018 7141018 7141018 7230012 7435745 7723361 7874984 7874984 7874984 7874984 7874984 7959566 THALIDOMIDE - THALOMID N020785 004 5629327 6045501 6235756 6315720 6561976 6561977 6755784 6869399 6908432 7141018 7435745 7723361 7874984 7874984 7874984 7874984 7874984 7959566 THYROTROPIN ALFA - THYROGEN N020898 001 5840566 6365127

May Aug Aug Mar Oct Oct Aug Aug Oct Oct Oct Oct Oct Oct Oct Oct Aug Aug Oct Oct Oct Oct Dec Nov Mar Aug Aug Aug Aug Aug Oct

13, 28, 28, 01, 23, 23, 28, 28, 23, 23, 23, 23, 23, 23, 23, 23, 28, 28, 23, 23, 23, 23, 09, 03, 01, 28, 28, 28, 28, 28, 23,

2014 2018 2018 2013 2020 2020 2018 2018 2020 2020 2020 2020 2020 2020 2020 2020 2018 2018 2020 2020 2020 2020 2023 2017 2013 2018 2018 2018 2018 2018 2020

May

25, 2013

May Aug Mar Oct Aug Oct Oct Oct Aug Oct Nov Mar Aug Aug Aug Aug Aug Oct

13, 28, 01, 23, 28, 23, 23, 23, 28, 23, 03, 01, 28, 28, 28, 28, 28, 23,

2014 2018 2013 2020 2018 2020 2020 2020 2018 2020 2017 2013 2018 2018 2018 2018 2018 2020

U-731 U-731 U-731 U-731 U-731 U-731 U-731 U-731 U-731 U-731 U-899 U-1058 U-371 U-1109 U-442 U-732 U-733 U-1155

ODE

May

23, 2013

Nov Nov

24, 2015 24, 2015

ODE DS DP U-556

Dec

14, 2014

TIAGABINE HYDROCHLORIDE - GABITRIL N020646 001 5010090 Sep 5354760 Mar 5866590 Apr 5958951 Jun TIAGABINE HYDROCHLORIDE - GABITRIL N020646 002 5010090 Sep 5354760 Mar 5866590 Apr 5958951 Jun

30, 24, 29, 10,

2011 2012 2016 2017

30, 24, 29, 10,

2011 2012 2016 2017

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 194 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)

TIAGABINE HYDROCHLORIDE - GABITRIL N020646 003 5010090 Sep 5354760 Mar 5866590 Apr 5958951 Jun TIAGABINE HYDROCHLORIDE - GABITRIL N020646 004 5010090 Sep 5354760 Mar 5866590 Apr 5958951 Jun TIAGABINE HYDROCHLORIDE - GABITRIL Sep N020646 005 5010090 Mar 5354760 Apr 5866590 Jun 5958951 TICAGRELOR - BRILINTA N022433 001 6251910 6525060 7250419 7265124 TIGECYCLINE - TYGACIL N021821 001 7879828 RE40086 RE40183 TIMOLOL MALEATE - ISTALOL N021516 001 6335335

30, 24, 29, 10,

2011 2012 2016 2017

30, 24, 29, 10,

2011 2012 2016 2017

30, 24, 29, 10,

2011 2012 2016 2017

Jul Dec Dec Jul

15, 02, 02, 09,

2018 2019 2019 2021

DS DS DS DS

NCE DP DP DP U-1171 U-1171 U-1171

Jul

20, 2016

Feb Jun Apr

05, 2029 25, 2013 09, 2016

DP U-282 DS DP

I-588 I-587 I-586

Mar Mar Mar

20, 2012 20, 2012 20, 2012

Nov

02, 2018

DP

TIMOLOL MALEATE - TIMOLOL MALEATE N020963 001 6174524 Mar 6174524*PED Sep TIMOLOL MALEATE - TIMOLOL MALEATE N020963 002 6174524 Mar 6174524*PED Sep TIOTROPIUM BROMIDE MONOHYDRATE N021395 001 5478578 6777423 6908928 6908928 7070800 7309707 7642268 7694676 8022082 RE38912 RE39820 TIPRANAVIR - APTIVUS N021814 001 5852195 5852195*PED 6147095 6147095*PED 6169181 6169181*PED 6231887 6231887*PED TIPRANAVIR - APTIVUS N022292 001 5852195 5852195*PED 6147095 6147095*PED 6169181 6169181*PED

26, 2019 26, 2019

DP

26, 2019 26, 2019

DP

- SPIRIVA Dec 26, 2012 Sep 24, 2021 Sep 24, 2021 Sep 24, 2021 Jan 22, 2022 Sep 24, 2021 Sep 24, 2021 Mar 12, 2027 Jan 19, 2026 Oct 11, 2021 Jan 30, 2018

DS DS DS DS DS

DS

DP DP DP DP DP DP DP DP DP DP DP

M-89 U-762 U-566 U-566

Dec

17, 2012

U-1186 U-566

Jun Dec Oct Apr May Nov Jul Jan

22, 22, 29, 29, 06, 06, 27, 27,

2019 2019 2019 2020 2014 2014 2018 2019

DS U-670 DS DP

PED

Dec

23, 2011

Jun Dec Oct Apr May Nov

22, 22, 29, 29, 06, 06,

2019 2019 2019 2020 2014 2014

DS U-670 DS

PED

Dec

23, 2011

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 195 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-230

EXCLUSIVITY CODE(S)

TIROFIBAN HYDROCHLORIDE - AGGRASTAT N020912 001 5292756 May 14, 2012 5733919 Oct 23, 2016 5965581 Oct 23, 2016 5972967 Oct 23, 2016 5978698 Oct 08, 2017 6136794 Jan 29, 2019 TIROFIBAN HYDROCHLORIDE - AGGRASTAT N020913 001 5292756 May 14, 2012 5733919 Oct 23, 2016 5965581 Oct 23, 2016 5972967 Oct 23, 2016 5978698 Oct 08, 2017 6136794 Jan 29, 2019 TIROFIBAN HYDROCHLORIDE - AGGRASTAT N020913 002 5292756 May 14, 2012 5733919 Oct 23, 2016 5965581 Oct 23, 2016 5972967 Oct 23, 2016 5978698 Oct 08, 2017 6136794 Jan 29, 2019 TIROFIBAN HYDROCHLORIDE - AGGRASTAT N020913 003 5292756 May 14, 2012 5733919 Oct 23, 2016 5965581 Oct 23, 2016 5972967 Oct 23, 2016 5978698 Oct 08, 2017 6136794 Jan 29, 2019 TIZANIDINE HYDROCHLORIDE - ZANAFLEX N021447 001 6455557 Nov 28, 2021 TIZANIDINE HYDROCHLORIDE - ZANAFLEX N021447 002 6455557 Nov 28, 2021 TIZANIDINE HYDROCHLORIDE - ZANAFLEX N021447 003 6455557 Nov 28, 2021 TOBRAMYCIN - TOBI N050753 001 5508269 TOLCAPONE - TASMAR N020697 001 5236952 5476875 TOLCAPONE - TASMAR N020697 002 5236952 5476875 TOLTERODINE TARTRATE - DETROL N020771 001 5382600 5382600*PED 5559269 5559269*PED TOLTERODINE TARTRATE - DETROL N020771 002 5382600 5382600*PED 5559269 5559269*PED

U-230

U-230

U-230

Oct

19, 2014

DP

U-909

Jan Dec

29, 2012 19, 2012

U-219

Jan Dec

29, 2012 19, 2012

U-219

Mar Sep Nov May

25, 25, 05, 05,

2012 2012 2013 2014

U-318

Mar Sep Nov May

25, 25, 05, 05,

2012 2012 2013 2014

U-318

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 196 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)

TOLTERODINE TARTRATE - DETROL LA Mar N021228 001 5382600 Sep 5382600*PED Nov 6630162 May 6630162*PED Aug 6770295 Feb 6770295*PED Aug 6911217 Feb 6911217*PED TOLTERODINE TARTRATE - DETROL LA Mar N021228 002 5382600 Sep 5382600*PED Nov 6630162 May 6630162*PED Aug 6770295 Feb 6770295*PED Aug 6911217 Feb 6911217*PED TOLVAPTAN - SAMSCA N022275 001 5753677 TOLVAPTAN - SAMSCA N022275 002 5753677 TOLVAPTAN - SAMSCA N022275 003 5753677 TOPIRAMATE - TOPAMAX N020505 001 5998380 5998380*PED 6503884 6503884*PED 7018983 7018983*PED 7498311 7498311*PED TOPIRAMATE - TOPAMAX N020505 002 5998380 5998380*PED 6503884 6503884*PED 7018983 7018983*PED 7498311 7498311*PED TOPIRAMATE - TOPAMAX N020505 003 5998380 5998380*PED 6503884 6503884*PED 7018983 7018983*PED 7498311 7498311*PED TOPIRAMATE - TOPAMAX N020505 004 5998380 5998380*PED 6503884 6503884*PED 7018983 7018983*PED 7498311 7498311*PED

25, 25, 11, 11, 26, 26, 26, 26,

2012 2012 2019 2020 2019 2020 2019 2020

DP DP DP DP

U-544 U-544 U-544 U-544

25, 25, 11, 11, 26, 26, 26, 26,

2012 2012 2019 2020 2019 2020 2019 2020

DP DP DP DP

U-544 U-544 U-544 U-544

May

19, 2015

U-978

NCE

May

19, 2014

May

19, 2015

U-978

NCE

May

19, 2014

May

19, 2015

U-978

NCE

May

19, 2014

Oct Apr Oct Apr Oct Apr Oct Apr

13, 13, 13, 13, 13, 13, 13, 13,

2015 2016 2015 2016 2015 2016 2015 2016

U-598 U-598 U-723 U-955

M-54 PED

Dec Jun

22, 2012 22, 2013

Oct Apr Oct Apr Oct Apr Oct Apr

13, 13, 13, 13, 13, 13, 13, 13,

2015 2016 2015 2016 2015 2016 2015 2016

U-598 U-598 U-723 U-955

M-54 PED

Dec Jun

22, 2012 22, 2013

Oct Apr Oct Apr Oct Apr Oct Apr

13, 13, 13, 13, 13, 13, 13, 13,

2015 2016 2015 2016 2015 2016 2015 2016

U-598 U-598 U-723 U-955

M-54 PED

Dec Jun

22, 2012 22, 2013

Oct Apr Oct Apr Oct Apr Oct Apr

13, 13, 13, 13, 13, 13, 13, 13,

2015 2016 2015 2016 2015 2016 2015 2016

U-598 U-598 U-723 U-955

M-54 PED

Dec Jun

22, 2012 22, 2013

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 197 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-598 U-598 U-723 U-955

EXCLUSIVITY CODE(S)
M-54 PED

TOPIRAMATE - TOPAMAX N020505 005 5998380 5998380*PED 6503884 6503884*PED 7018983 7018983*PED 7498311 7498311*PED TOPIRAMATE - TOPAMAX N020505 006 5998380 5998380*PED 6503884 6503884*PED 7018983 7018983*PED 7498311 7498311*PED TOPIRAMATE - TOPAMAX N020844 001 5998380 5998380*PED 6503884 6503884*PED 7018983 7018983*PED 7125560 7125560*PED 7498311 7498311*PED TOPIRAMATE - TOPAMAX N020844 002 5998380 5998380*PED 6503884 6503884*PED 7018983 7018983*PED 7125560 7125560*PED 7498311 7498311*PED TOPIRAMATE - TOPAMAX SPRINKLE N020844 003 5998380 5998380*PED 6503884 6503884*PED 7018983 7018983*PED 7125560 7125560*PED 7498311 7498311*PED

Oct Apr Oct Apr Oct Apr Oct Apr

13, 13, 13, 13, 13, 13, 13, 13,

2015 2016 2015 2016 2015 2016 2015 2016

Dec Jun

22, 2012 22, 2013

Oct Apr Oct Apr Oct Apr Oct Apr

13, 13, 13, 13, 13, 13, 13, 13,

2015 2016 2015 2016 2015 2016 2015 2016

U-598 U-598 U-723 U-955

M-54 PED

Dec Jun

22, 2012 22, 2013

Oct Apr Oct Apr Oct Apr Mar Sep Oct Apr

13, 13, 13, 13, 13, 13, 01, 01, 13, 13,

2015 2016 2015 2016 2015 2016 2019 2019 2015 2016

U-598 U-598 U-723 U-766 U-955

M-54 PED

Dec Jun

22, 2012 22, 2013

Oct Apr Oct Apr Oct Apr Mar Sep Oct Apr

13, 13, 13, 13, 13, 13, 01, 01, 13, 13,

2015 2016 2015 2016 2015 2016 2019 2019 2015 2016

U-598 U-598 U-723 U-766 U-955

M-54 PED

Dec Jun

22, 2012 22, 2013

Oct Apr Oct Apr Oct Apr Mar Sep Oct Apr

13, 13, 13, 13, 13, 13, 01, 01, 13, 13,

2015 2016 2015 2016 2015 2016 2019 2019 2015 2016

U-598 U-598 U-723 U-766 U-955

M-54 PED

Dec Jun

22, 2012 22, 2013

TOPOTECAN HYDROCHLORIDE - HYCAMTIN Oct N020671 001 5674872 Apr 5674872*PED TRAMADOL HYDROCHLORIDE - CONZIP N022370 001 7858118 Apr TRAMADOL HYDROCHLORIDE - CONZIP N022370 002 7858118 Apr TRAMADOL HYDROCHLORIDE - CONZIP Apr N022370 003 7858118

07, 2014 07, 2015

U-910

11, 2022

DP

U-1104

11, 2022

DP

U-1104

11, 2022

DP

U-1104

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 198 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DP DP DP DP

EXCLUSIVITY CODE(S)
NP

TRAMADOL HYDROCHLORIDE - RYZOLT May N021745 001 5591452 May 6254887 Jun 6607748 Oct 7988998 TRAMADOL HYDROCHLORIDE - RYZOLT May N021745 002 5591452 May 6254887 Jun 6607748 Oct 7988998 TRAMADOL HYDROCHLORIDE - RYZOLT May N021745 003 5591452 May 6254887 Jun 6607748 Oct 7988998

10, 10, 29, 27,

2014 2014 2020 2023

Dec

30, 2011

10, 10, 29, 27,

2014 2014 2020 2023

DP DP DP DP

NP

Dec

30, 2011

10, 10, 29, 27,

2014 2014 2020 2023

DP DP DP DP

NP

Dec

30, 2011

TRAMADOL HYDROCHLORIDE - TRAMADOL HYDROCHLORIDE N021693 001 5464632 Mar 22, 2013 6106861 Dec 05, 2017 TRAMADOL HYDROCHLORIDE - ULTRAM Oct N020281 001 6339105 Apr 6339105*PED TRAMADOL HYDROCHLORIDE - ULTRAM Oct N020281 002 6339105 Apr 6339105*PED TRANDOLAPRIL - MAVIK N020528 001 5744496 TRANDOLAPRIL - MAVIK N020528 002 5744496 TRANDOLAPRIL - MAVIK N020528 003 5744496

DP DP

12, 2019 12, 2020

U-435 U-435

12, 2019 12, 2020

U-435 U-435

Apr

28, 2015

U-229

Apr

28, 2015

U-229

Apr

28, 2015

U-229

TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE - TARKA N020591 001 5721244 Feb 24, 2015 TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE - TARKA N020591 002 5721244 Feb 24, 2015 TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE - TARKA N020591 003 5721244 Feb 24, 2015 TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE - TARKA N020591 004 5721244 Feb 24, 2015 TRANEXAMIC ACID - LYSTEDA N022430 001 7947739 8022106 TRAVOPROST - TRAVATAN N021257 001 5510383 5631287 5849792 5889052 6011062 TRAVOPROST - TRAVATAN Z N021994 001 5510383 5889052 6503497 6849253

Mar Mar

04, 2025 04, 2025

DP U-1182

NDF

Nov

13, 2012

Aug Dec Dec Dec Dec

03, 22, 22, 02, 22,

2013 2014 2014 2014 2014

DP DP DP DP

U-383 U-382 U-383 U-383

Aug Dec May May

03, 02, 06, 06,

2013 2014 2012 2012

DP DP DP DP

U-383 U-383

TRAZODONE HYDROCHLORIDE - OLEPTRO N022411 001 6607748 Jun 7829120 Mar

29, 2020 27, 2027

DP DP

NDF U-796

Feb

02, 2013

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 199 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DP DP

EXCLUSIVITY CODE(S)
NDF

TRAZODONE HYDROCHLORIDE - OLEPTRO N022411 002 6607748 Jun 7829120 Mar TREPROSTINIL SODIUM - REMODULIN N021272 001 5153222 Oct 6765117 Oct 7999007 Mar TREPROSTINIL SODIUM - REMODULIN N021272 002 5153222 Oct 6765117 Oct 7999007 Mar TREPROSTINIL SODIUM - REMODULIN N021272 003 5153222 Oct 6765117 Oct 7999007 Mar TREPROSTINIL SODIUM - REMODULIN N021272 004 5153222 Oct 6765117 Oct 7999007 Mar TREPROSTINIL SODIUM - TYVASO N022387 001 5153222 6521212 6756033 6765117 TRETINOIN - ATRALIN N022070 001 5670547 TRETINOIN - RENOVA N021108 001 6531141 TRETINOIN - RETIN-A MICRO N020475 001 5955109 TRETINOIN - RETIN-A MICRO N020475 002 5955109

29, 2020 27, 2027

Feb

02, 2013

U-796

06, 2014 24, 2017 29, 2029

U-455 DS DP U-1174

06, 2014 24, 2017 29, 2029

U-455 DS DP U-1174

06, 2014 24, 2017 29, 2029

U-455 DS DP U-1174

06, 2014 24, 2017 29, 2029

U-455 DS DP U-1174

Oct Nov Nov Oct

16, 13, 13, 24,

2014 2018 2018 2017

U-1019 U-1018 U-1018 DS

NDF ODE

Jul Jul

30, 2012 30, 2016

Sep

23, 2014

DP

Mar

07, 2020

Sep

21, 2016

DP

U-134

Sep

21, 2016

U-134

TRIAMCINOLONE ACETONIDE - NASACORT AQ N020468 001 5976573 Jul 03, 5976573 Jul 03, 6143329 Jul 03, 7977045 Jul 03,

2016 2016 2016 2016

DP DP DP DP

U-295 U-896 U-896 U-896

NPP

Sep

19, 2011

TRIAMCINOLONE ACETONIDE - TRIESENCE N022048 001 6395294 Jan 13, 2020 TRIMETHOPRIM HYDROCHLORIDE - PRIMSOL Aug 07, 2016 A074973 001 5763449 Aug 07, 2016 5962461 TRIMETREXATE GLUCURONATE - NEUTREXIN May 18, 2018 N020326 001 6017922 TRIMETREXATE GLUCURONATE - NEUTREXIN May 18, 2018 N020326 002 6017922 TRIPTORELIN PAMOATE - TRELSTAR N020715 001 5776885 Jul TRIPTORELIN PAMOATE - TRELSTAR N021288 001 5776885 Jul TRIPTORELIN PAMOATE - TRELSTAR N022437 001 5776885 Jul

DP

U-846

07, 2015

07, 2015

DP

07, 2015

DP

NP

Mar

10, 2013

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 200 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-173 U-251 U-301 U-317

EXCLUSIVITY CODE(S)

TROGLITAZONE - PRELAY N020719 001 5602133 5859037 6011049 6046202 TROGLITAZONE - PRELAY N020719 002 5602133 5859037 6011049 6046202 TROGLITAZONE - PRELAY N020719 003 5602133 5859037 6011049 6046202 TROGLITAZONE - REZULIN N020720 001 5602133 5859037 6011049 6046202 TROGLITAZONE - REZULIN N020720 002 5602133 5859037 6011049 6046202 TROGLITAZONE - REZULIN N020720 003 5602133 5859037 6011049 6046202

Sep Nov Nov Sep

15, 13, 13, 15,

2013 2017 2017 2013

Sep Nov Nov Sep

15, 13, 13, 15,

2013 2017 2017 2013

U-173 U-251 U-301 U-317

Sep Nov Nov Sep

15, 13, 13, 15,

2013 2017 2017 2013

U-173 U-251 U-301 U-317

Sep Nov Nov Sep

15, 13, 13, 15,

2013 2017 2017 2013

U-173 U-251 U-301 U-317

Sep Nov Nov Sep

15, 13, 13, 15,

2013 2017 2017 2013

U-173 U-251 U-301 U-317

Sep Nov Nov Sep

15, 13, 13, 15,

2013 2017 2017 2013

U-173 U-251 U-301 U-317

TROSPIUM CHLORIDE - SANCTURA XR N022103 001 7410978 Feb 7759359 Nov 7763635 Nov 7781448 Nov 7781449 Nov TROVAFLOXACIN MESYLATE - TROVAN N020759 001 5164402 Dec 5763454 Jun 6187341 Jan TROVAFLOXACIN MESYLATE - TROVAN N020759 002 5164402 Dec 5763454 Jun 6187341 Jan TRYPAN BLUE - MEMBRANEBLUE N022278 001 ULIPRISTAL ACETATE - ELLA N022474 001 UNOPROSTONE ISOPROPYL - RESCULA N021214 001 5221763 Jul 6458836 Jul UROFOLLITROPIN - FERTINEX N019415 004 5767067 UROFOLLITROPIN - FERTINEX N019415 005 5767067

01, 04, 04, 04, 04,

2025 2024 2024 2024 2024

DP U-1071 U-1071 U-1071 U-1071

18, 2011 15, 2015 20, 2019

U-282 U-282

18, 2011 15, 2015 20, 2019

U-282 U-282

ODE

Dec

16, 2011

NCE 15, 2012 09, 2021 DS U-333

Aug

13, 2015

Jun

16, 2015

Jun

16, 2015

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 201 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DP DP DS DS U-530 U-894 U-894 U-530

EXCLUSIVITY CODE(S)
I-570 NPP PED PED

VALACYCLOVIR HYDROCHLORIDE - VALTREX N020487 001 5879706 Jan 19, 2016 5879706 Jan 19, 2016 5879706*PED Jul 19, 2016 6107302 Jan 19, 2016 6107302 Jan 19, 2016 6107302*PED Jul 19, 2016 VALACYCLOVIR HYDROCHLORIDE - VALTREX N020487 002 5879706 Jan 19, 2016 5879706 Jan 19, 2016 5879706*PED Jul 19, 2016 6107302 Jan 19, 2016 6107302 Jan 19, 2016 6107302*PED Jul 19, 2016 VALDECOXIB - BEXTRA N021341 002 5633272 VALDECOXIB - BEXTRA N021341 003 5633272

Sep Sep Mar Mar

02, 02, 02, 02,

2011 2011 2012 2012

DP DP DS DS

U-894 U-530 U-530 U-894

I-570 NPP PED PED

Sep Sep Mar Mar

02, 02, 02, 02,

2011 2011 2012 2012

Feb

13, 2015

U-462

Feb

13, 2015

U-462

VALGANCICLOVIR HYDROCHLORIDE - VALCYTE Mar 29, 2015 N021304 001 6083953 Mar 29, 2015 6083953 Sep 29, 2015 6083953*PED VALGANCICLOVIR HYDROCHLORIDE - VALCYTE N022257 001 6083953 Mar 29, 2015 6083953 Mar 29, 2015

DS DS

DP DP

U-384 U-854

D-125 I-604 PED

Aug Aug Feb

05, 2013 28, 2012 28, 2013

DS DS

DP DP

U-384 U-854

D-125 NDF PED

Aug Aug Feb

05, 2013 28, 2012 28, 2013

VALSARTAN - DIOVAN N020665 001 5399578 5399578*PED VALSARTAN - DIOVAN N020665 002 5399578 5399578*PED VALSARTAN - DIOVAN N021283 001 5399578 5399578*PED 5972990 5972990*PED 6294197 6294197*PED VALSARTAN - DIOVAN N021283 002 5399578 5399578*PED 5972990 5972990*PED 6294197 6294197*PED VALSARTAN - DIOVAN N021283 003 5399578 5399578*PED 5972990 5972990*PED 6294197 6294197*PED

Mar Sep

21, 2012 21, 2012

U-3

Mar Sep

21, 2012 21, 2012

U-3

Mar Sep Oct Apr Jun Dec

21, 21, 26, 26, 18, 18,

2012 2012 2016 2017 2017 2017

U-692 U-3

Mar Sep Oct Apr Jun Dec

21, 21, 26, 26, 18, 18,

2012 2012 2016 2017 2017 2017

U-692 U-3

Mar Sep Oct Apr Jun Dec

21, 21, 26, 26, 18, 18,

2012 2012 2016 2017 2017 2017

U-692 U-3

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 202 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)

VALSARTAN - DIOVAN N021283 004 5399578 5399578*PED 5972990 5972990*PED 6294197 6294197*PED VANDETANIB - VANDETANIB N022405 001 7173038 8067427 RE42353 VANDETANIB - VANDETANIB N022405 002 7173038 8067427 RE42353

Mar Sep Oct Apr Jun Dec

21, 21, 26, 26, 18, 18,

2012 2012 2016 2017 2017 2017

U-692 U-3

Aug Aug Sep

14, 2021 08, 2028 23, 2017

DS DS

DP DP DP

NCE ODE

Apr Apr

06, 2016 06, 2018

Aug Aug Sep

14, 2021 08, 2028 23, 2017

DS DS

DP DP DP

NCE ODE

Apr Apr

06, 2016 06, 2018

VARDENAFIL HYDROCHLORIDE - LEVITRA N021400 001 6362178 Oct 7696206 Oct VARDENAFIL HYDROCHLORIDE - LEVITRA N021400 002 6362178 Oct 7696206 Oct VARDENAFIL HYDROCHLORIDE - LEVITRA N021400 003 6362178 Oct 7696206 Oct VARDENAFIL HYDROCHLORIDE - LEVITRA N021400 004 6362178 Oct 7696206 Oct VARDENAFIL HYDROCHLORIDE - STAXYN N200179 001 6362178 Oct 7696206 Oct VARENICLINE TARTRATE - CHANTIX May N021928 001 6410550 May 6890927 Aug 7265119 VARENICLINE TARTRATE - CHANTIX N021928 002 6410550 May 6890927 May Aug 7265119 VELAGLUCERASE ALFA - VPRIV N022575 001 VELAGLUCERASE ALFA - VPRIV N022575 002 VEMURAFENIB - ZELBORAF N202429 001 7504509 7863288

31, 2018 31, 2018

DS DS

DP DP

U-533 U-533

31, 2018 31, 2018

DS DS

DP DP

U-533 U-533

31, 2018 31, 2018

DS DS

DP DP

U-533 U-533

31, 2018 31, 2018

DS DS

DP DP

U-533 U-533

31, 2018 31, 2018

U-155 U-155

NDF

Jun

17, 2013

10, 2020 06, 2022 03, 2022

DS DS DS

DP DP DP

U-56 U-56 U-56

M-105

Jul

22, 2014

10, 2020 06, 2022 03, 2022

DS DS DS

DP DP DP

U-56 U-56 U-56

M-105

Jul

22, 2014

NCE

Feb

26, 2015

NCE Oct Jun 22, 2026 20, 2029 DS DS DP DP

Feb

26, 2015

NCE ODE

Aug Aug

17, 2016 17, 2018

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 203 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-398 U-398

EXCLUSIVITY CODE(S)

VENLAFAXINE HYDROCHLORIDE - EFFEXOR XR N020699 001 5916923 Jun 28, 2013 5916923*PED Dec 28, 2013 6274171 Mar 20, 2017 6274171*PED Sep 20, 2017 6310101 Jun 28, 2013 6403120 Mar 20, 2017 6403120 Mar 20, 2017 6403120*PED Sep 20, 2017 6403120*PED Sep 20, 2017 6419958 Mar 20, 2017 6419958 Mar 20, 2017 6419958*PED Sep 20, 2017 6419958*PED Sep 20, 2017 6444708 Jun 28, 2013 6444708*PED Dec 28, 2013 VENLAFAXINE HYDROCHLORIDE - EFFEXOR XR N020699 002 5916923 Jun 28, 2013 5916923*PED Dec 28, 2013 6274171 Mar 20, 2017 6274171*PED Sep 20, 2017 6310101 Jun 28, 2013 6403120 Mar 20, 2017 6403120 Mar 20, 2017 6403120*PED Sep 20, 2017 6403120*PED Sep 20, 2017 6419958 Mar 20, 2017 6419958 Mar 20, 2017 6419958*PED Sep 20, 2017 6419958*PED Sep 20, 2017 6444708 Jun 28, 2013 6444708*PED Dec 28, 2013 VENLAFAXINE HYDROCHLORIDE - EFFEXOR XR N020699 003 5916923 Jun 28, 2013 5916923*PED Dec 28, 2013 6274171 Mar 20, 2017 6274171*PED Sep 20, 2017 6403120 Mar 20, 2017 6403120 Mar 20, 2017 6403120*PED Sep 20, 2017 6403120*PED Sep 20, 2017 6419958 Mar 20, 2017 6419958 Mar 20, 2017 6419958*PED Sep 20, 2017 6419958*PED Sep 20, 2017 6444708 Jun 28, 2013 6444708*PED Dec 28, 2013 VENLAFAXINE HYDROCHLORIDE - EFFEXOR XR N020699 004 5916923 Jun 28, 2013 5916923*PED Dec 28, 2013 6274171 Mar 20, 2017 6274171*PED Sep 20, 2017 6310101 Jun 28, 2013 6403120 Mar 20, 2017 6403120 Mar 20, 2017 6403120*PED Sep 20, 2017 6403120*PED Sep 20, 2017 6419958 Mar 20, 2017 6419958 Mar 20, 2017 6419958*PED Sep 20, 2017 6419958*PED Sep 20, 2017 6444708 Jun 28, 2013 6444708*PED Dec 28, 2013

U-46 U-451 U-535 U-535 U-451 U-459 U-535 U-535 U-459 U-398 U-398

U-398 U-398

U-46 U-451 U-535 U-451 U-535 U-535 U-459 U-535 U-459 U-398 U-398

U-398 U-398

U-535 U-451 U-535 U-451 U-535 U-459 U-459 U-535 U-398 U-398

U-398 U-398

U-46 U-535 U-451 U-535 U-451 U-535 U-459 U-535 U-459 U-398 U-398

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 204 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-839 U-535 U-839 U-535

EXCLUSIVITY CODE(S)

VENLAFAXINE HYDROCHLORIDE - VENLAFAXINE HYDROCHLORIDE N022104 001 6403120 Mar 20, 2017 6403120 Mar 20, 2017 6419958 Mar 20, 2017 6419958 Mar 20, 2017 VENLAFAXINE HYDROCHLORIDE - VENLAFAXINE HYDROCHLORIDE N022104 002 6403120 Mar 20, 2017 6403120 Mar 20, 2017 6419958 Mar 20, 2017 6419958 Mar 20, 2017 VENLAFAXINE HYDROCHLORIDE - VENLAFAXINE HYDROCHLORIDE N022104 003 6403120 Mar 20, 2017 6403120 Mar 20, 2017 6419958 Mar 20, 2017 6419958 Mar 20, 2017 VENLAFAXINE HYDROCHLORIDE - VENLAFAXINE HYDROCHLORIDE N022104 004 6403120 Mar 20, 2017 6403120 Mar 20, 2017 6419958 Mar 20, 2017 6419958 Mar 20, 2017 VERAPAMIL HYDROCHLORIDE - COVERA-HS Apr 04, 2017 N020552 001 6096339 VERAPAMIL HYDROCHLORIDE - COVERA-HS Apr 04, 2017 N020552 002 6096339 VERTEPORFIN - VISUDYNE N021119 001 5095030 5707608 5756541 5770619 5798349 6074666 VIGABATRIN - SABRIL N020427 001 VIGABATRIN - SABRIL N022006 001 VILAZODONE HYDROCHLORIDE - VIIBRYD Sep N022567 001 5532241 Jun 7834020 VILAZODONE HYDROCHLORIDE - VIIBRYD Sep N022567 002 5532241 Jun 7834020 VILAZODONE HYDROCHLORIDE - VIIBRYD Sep N022567 003 5532241 Jun 7834020 VORICONAZOLE - VFEND N021266 001 5364938 5567817 VORICONAZOLE - VFEND N021266 002 5364938 5567817 VORICONAZOLE - VFEND N021267 001 5364938 5567817 6632803

U-839 U-535 U-839 U-535

U-839 U-535 U-535 U-839

U-839 U-535 U-839 U-535

U-365

U-365

Sep Aug Mar Jan Aug Feb

09, 02, 11, 06, 25, 05,

2011 2015 2016 2015 2015 2012

DS U-357 U-357 U-357

NCE

Aug

21, 2014

NCE ODE 29, 2014 05, 2022 DS DS DP DP

Aug Aug

21, 2014 21, 2016

NCE U-839

Jan

21, 2016

29, 2014 05, 2022

DS DS

DP DP

NCE U-839

Jan

21, 2016

29, 2014 05, 2022

DS DS

DP DP

NCE U-839

Jan

21, 2016

Nov May

15, 2011 24, 2016

DS DS

DP

U-540

Nov May

15, 2011 24, 2016

DS DS

DP

U-540

Nov May Jun

15, 2011 24, 2016 02, 2018

DS DS

DP DP

U-540

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 205 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DS DS

EXCLUSIVITY CODE(S)

VORICONAZOLE - VFEND N021630 001 5364938 5567817 VORINOSTAT - ZOLINZA N021991 001 6087367 7399787 7456219 7652069 7732490 7851509 8067472 RE38506 ZAFIRLUKAST - ACCOLATE N020547 001 5294636 5319097 5482963 5612367 6143775 ZAFIRLUKAST - ACCOLATE N020547 003 5294636 5319097 5482963 5612367 6143775 ZANAMIVIR - RELENZA N021036 001 5360817 5648379 5648379 5648379 6294572 ZICONOTIDE - PRIALT N021060 003 5364842 5364842 5795864 5859186 5859186 ZICONOTIDE ACETATE - PRIALT N021060 001 5364842 5364842 5795864 5859186 5859186 ZICONOTIDE ACETATE - PRIALT N021060 002 5364842 5364842 5795864 5859186 5859186 ZICONOTIDE ACETATE - PRIALT N021060 004 5364842 5364842 5795864 5859186 5859186 ZILEUTON - ZYFLO CR N022052 001 5422123 6183778

Nov May

15, 2011 24, 2016

DP

U-540

Oct Feb Nov Mar Mar Feb Mar Nov

04, 09, 14, 04, 04, 21, 04, 29,

2011 2025 2026 2023 2023 2024 2023 2012

U-776 U-892 DS DP DP DS DP U-892 U-892 U-892

NCE ODE

Oct Oct

06, 2011 06, 2013

Dec Dec Jan Mar Dec

11, 11, 09, 18, 11,

2011 2011 2013 2014 2011

U-189

Dec Dec Jan Mar Dec

11, 11, 09, 18, 11,

2011 2011 2013 2014 2011

U-189

Jul Jul Jul Jul Dec

26, 15, 15, 15, 15,

2013 2014 2014 2014 2014

DS

DP U-721 U-722 U-274

DS

DP

Dec Dec Jun Dec Dec

30, 30, 27, 30, 30,

2016 2016 2015 2011 2011

U-48 U-55 DP U-55 U-48

Dec Dec Jun Dec Dec

30, 30, 27, 30, 30,

2016 2016 2015 2011 2011

U-48 U-55 DP U-55 U-48

Dec Dec Jun Dec Dec

30, 30, 27, 30, 30,

2016 2016 2015 2011 2011

U-48 U-55 DP U-48 U-55

Dec Dec Jun Dec Dec

30, 30, 27, 30, 30,

2016 2016 2015 2011 2011

U-55 U-48 DP U-55 U-48

Jun Sep

06, 2012 21, 2013

DP DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 206 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DS DS DP DP DP U-720

EXCLUSIVITY CODE(S)
I-615

ZIPRASIDONE HYDROCHLORIDE - GEODON N020825 001 4831031 Mar 5312925 Sep May 6150366 Dec 6245766 ZIPRASIDONE HYDROCHLORIDE - GEODON N020825 002 4831031 Mar 5312925 Sep May 6150366 Dec 6245766 ZIPRASIDONE HYDROCHLORIDE - GEODON N020825 003 4831031 Mar 5312925 Sep May 6150366 Dec 6245766 ZIPRASIDONE HYDROCHLORIDE - GEODON N020825 004 4831031 Mar 5312925 Sep May 6150366 Dec 6245766 ZIPRASIDONE HYDROCHLORIDE - GEODON Mar N021483 001 4831031 Sep 5312925 May 6150366 Dec 6245766 May 7175855 ZIPRASIDONE MESYLATE - GEODON N020919 001 4831031 6110918 6232304 6399777 ZOLEDRONIC ACID - RECLAST N021817 001 4939130 4939130*PED 7932241 7932241*PED 8052987 ZOLEDRONIC ACID - ZOMETA N021223 001 4939130 4939130*PED ZOLEDRONIC ACID - ZOMETA N021223 002 4939130 4939130*PED ZOLEDRONIC ACID - ZOMETA N021223 003 4939130 4939130*PED 7932241 ZOLMITRIPTAN - ZOMIG N020768 001 5466699 5466699*PED 5863935 5863935*PED ZOLMITRIPTAN - ZOMIG N020768 002 5466699 5466699*PED 5863935 5863935*PED

02, 01, 27, 18,

2012 2012 2019 2018

Nov

20, 2012

U-601

02, 01, 27, 18,

2012 2012 2019 2018

DS DS

DP DP DP

U-720

I-615

Nov

20, 2012

U-601

02, 01, 27, 18,

2012 2012 2019 2018

DS DS

DP DP DP

U-720

I-615

Nov

20, 2012

U-601

02, 01, 27, 18,

2012 2012 2019 2018

DS DS

DP DP DP

U-720

I-615

Nov

20, 2012

U-601

02, 01, 27, 18, 18,

2012 2012 2019 2018 2020

DS DS

DP DP DP DP

U-720 U-720 U-719 U-601

Mar Mar Apr Apr

02, 26, 01, 01,

2012 2017 2017 2017

DS

DP

U-720

Sep Mar Feb Aug Mar

02, 02, 05, 05, 19,

2012 2013 2028 2028 2024

DS

DP DP

U-662

I-595 I-584 I-581

May Mar Dec

29, 2012 15, 2012 19, 2011

U-1199

Sep Mar

02, 2012 02, 2013

DS

DP

U-53

Sep Mar

02, 2012 02, 2013

DS

DP

U-53

PED

Sep

20, 2011

Sep Mar Feb

02, 2012 02, 2013 05, 2028

DS

DP DP

U-53

Nov May Nov May

14, 14, 14, 14,

2012 2013 2012 2013

Nov May Nov May

14, 14, 14, 14,

2012 2013 2012 2013

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 207 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-436 DP DP

EXCLUSIVITY CODE(S)

ZOLMITRIPTAN - ZOMIG N021450 004 5466699 5466699*PED 6750237 6750237*PED 7220767 7220767*PED ZOLMITRIPTAN - ZOMIG-ZMT N021231 001 5466699 5466699*PED ZOLMITRIPTAN - ZOMIG-ZMT N021231 002 5466699 5466699*PED ZOLPIDEM TARTRATE - AMBIEN CR N021774 001 6514531 6514531*PED ZOLPIDEM TARTRATE - AMBIEN CR N021774 002 6514531 6514531*PED ZOLPIDEM TARTRATE - EDLUAR N021997 001 6761910 ZOLPIDEM TARTRATE - EDLUAR N021997 002 6761910

Nov May Nov May Nov May

14, 14, 28, 28, 28, 28,

2012 2013 2020 2021 2020 2021

Nov May

14, 2012 14, 2013

Nov May

14, 2012 14, 2013

Dec Jun

01, 2019 01, 2020

DP

Dec Jun

01, 2019 01, 2020

DP

Sep

24, 2019

DP

U-674

Sep

24, 2019

DP

U-674

ZOLPIDEM TARTRATE - INTERMEZZO Apr N022328 001 7658945 Feb 7682628 ZOLPIDEM TARTRATE - INTERMEZZO Apr N022328 002 7658945 Feb 7682628 ZOLPIDEM TARTRATE - ZOLPIMIST N022196 001 7632517

15, 2027 16, 2025

DP

U-1194 U-1194

NP

Nov

23, 2014

15, 2027 16, 2025

DP

U-1194 U-1194

NP

Nov

23, 2014

Oct

01, 2017

U-70

Footnote: 1. Patents are published upon receipt by the Orange Book Staff and may not reflect the official receipt date as described in 21 CFR 314.53(d)(5). 2. Patents listed prior to August 18, 2003 are flagged with method of use claims only as applicable and submitted by the sponsor. They may not be flagged with respect to other claims which may apply.

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

PATENT & EXCLUSIVITY ABBREVIATIONS
D I M NC NCE NDF NE NP NP* NPP NR NS ODE PC PED RTO U W

ADB 1 of 51

NEW DOSING SCHEDULE (SEE INDIVIDUAL REFERENCES) NEW INDICATION (SEE INDIVIDUAL REFERENCES) MISCELLANEOUS EXCLUSIVITY CODES (SEE INDIVIDUAL REFERENCES) NEW COMBINATION NEW CHEMICAL ENTITY NEW DOSAGE FORM NEW ESTER OR SALT OF AN ACTIVE INGREDIENT NEW PRODUCT NEW PRODUCT (MINT FLAVORED) NEW PATIENT POPULATION NEW ROUTE NEW STRENGTH ORPHAN DRUG EXCLUSIVITY PATENT CHALLENGE PEDIATRIC EXCLUSIVITY RX TO OTC SWITCH OR OTC USE PATENT USE CODE (SEE INDIVIDUAL REFERENCES) EXCLUSIVITY ON THIS APPLICATION EXPIRING ON THIS DATE HAS BEEN WAIVED BY SPONSOR - SEE SECTION 1.8 OF ORANGE BOOK PREFACE WAIVED EXCLUSIVITY

EXCLUSIVITY DOSING SCHEDULE

D-1 D-2 D-3 D-4 D-5 D-6 D-7 D-8 D-9 D-10 D-11 D-12 D-13 D-14 D-15 D-16 D-17 D-18 D-19 D-20 D-21 D-22 D-23 D-24 D-25 D-26 D-27 D-28 D-29 D-30 D-31 D-32 D-33 D-34 D-35 D-36 ONCE A DAY APPLICATION ONCE DAILY DOSING SEVEN DAYS/SEVEN DAYS/SEVEN DAYS DOSING SCHEDULE SEVEN DAYS/FOURTEEN DAYS DOSING SCHEDULE TEN DAYS/ELEVEN DAYS DOSING SCHEDULE SEVEN DAYS/NINE DAYS/FIVE DAYS DOSING SCHEDULE BID DOSING INTRAVENOUS, EPIDURAL AND INTRATHECAL DOSING NARCOTIC OVERDOSE IN ADULTS NARCOTIC OVERDOSE IN CHILDREN POSTOPERATIVE NARCOTIC DEPRESSION IN CHILDREN BEDTIME DOSING OF 800MG FOR TREATMENT OF ACTIVE DUODENAL ULCER INCREASED MAXIMUM DAILY DOSAGE RECOMMENDATION BEDTIME DOSING OF 800MG FOR TREATMENT OF ACTIVE BENIGN GASTRIC ULCER SINGLE DAILY DOSE OF 25MG/37.5MG CONTINUOUS INTRAVENOUS INFUSION 400MG EVERY 12 HOURS FOR THREE DAYS FOR UNCOMPLICATED URINARY TRACT INFECTIONS LOWER RECOMMENDED STARTING DOSE GUIDELINES BOLUS DOSING GUIDELINES SINGLE 32MG DOSE ALTERNATIVE DOSAGE OF 300MG ONCE DAILY AFTER THE EVENING MEAL REDUCTION IN INFUSION TIME FROM 24 TO 4 HOURS FOR THE 60MG DOSE INCREASE MAXIMUM DOSE AND VARIATIONS IN THE DOSING REGIMEN FOR OVARIAN CANCER THE RECOMMENDED REGIMEN IS 135MG/M2 OR 175MG/M2 INTRAVENOUSLY OVER THREE HOURS EVERY THREE WEEKS ADDITIONAL DOSAGE REGIMEN EQUAL TO HALF THE ORIGINAL DOSING REGIMEN ONCE WEEKLY APPLICATION BID DOSING IN PATIENTS 12 YEARS OF AGE AND OLDER FOR PREVENTION OF NAUSEA AND VOMITING ASSOCIATED WITH MODERATE EMETOGENIC CANCER CHEMOTHERAPY USE OF ISOVUE-370 IN EXCRETORY UROGRAPHY AT EQUIVALENT GRAMS OF IODINE TO THE CURRENTLY APPROVED ISOVUE-250 AND ISOVUE-300 INCREASE OF CUMULATIVE DOSE TO 0.3MMOL/KG FOR MRI OF CNS IN ADULTS 5000 IU DOSE FOR PHOPHYLAXIX AGAINST DEEP VEIN THROMBOSIS CHANGE IN RECOMMENDED TOTAL DAILY DOSE TO 80MG (40MG BID) REMOVAL OF THE RESTRICTIONS LIMITING TREATMENT TO TWO CONSECUTIVE WEEKS AND TO SMALL AREAS ONCE DAILY DOSING FOR PLAQUE PSORIASIS EVERY FOUR MONTHS DOSAGE REGIMEN FOR A ONE WEEK DOSING OF INTERDIGITAL TINEA PEDIS FOR A SINGLE 2MG DOSE AS AN ALTERNATIVE TO THE 1MG DOSE GIVEN TWICE DAILY

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

EXCLUSIVITY DOSING SCHEDULE
D-37 D-38 D-39

ADB 2 of 51

D-40 D-41 D-42 D-43 D-44

D-45 D-46 D-47 D-48 D-49 D-50 D-51 D-52 D-53 D-54 D-55 D-56 D-57 D-58 D-59 D-60 D-61 D-62 D-63 D-64 D-65 D-66 D-67 D-68 D-69 D-70 D-71 D-72 D-73 D-74 D-75 D-76 D-77 D-78 D-79

DOSING REGIMEN FOR ADMINISTRATION EITHER ONCE DAILY (QD) OR TWICE DAILY (BID) CONTINUOUS INFUSION AS AN ALTERNATE METHOD OF ADMINISTRATION CHANGE IN TIME TO TAKE THE DRUG PRIOR TO A MEAL TO PREVENT MEAL-INDUCED HEARTBURN SYMPTOMS FROM "..1/2 TO 1 HOUR BEFORE EATING" TO ".. RIGHT BEFORE EATING OR UP TO 60MIN BEFORE CONSUMING..." ONCE-A-DAY DOSING REGIMEN DRUG MAY BE DOSED RIGHT BEFORE A MEAL OR ANY TIME UP TO 30MIN BEFORE EATING OR DRINKING FOOD AND BEVERAGES THAT WOULD BE EXPECTED TO CAUSE SYMPTOMS TEN DAY DOSING REGIMEN FOR TRIPLE THERAPY, PREVACID IN COMBINATION WITH CLARITHROMYCIN AND AMOXICILLIN, FOR THE ERADICATION OF H.PYLORI IN PATIENTS WITH DUODENAL ULCER DISEASE INITIATION OF TREATMENT WITH 900MG/DAY BY DELETION OF THE REQUIREMENT TO TITRATE TO 900MG/DAY OVER A 3-DAY PERIOD IN A CLINICAL TRIAL, FEWER DISCONTINUATIONS DUE TO ADVERSE EVENTS, ESPECIALLY DIZZINESS AND VERTIGO, WERE OBSERVED WHEN TITRATING THE DOSE IN INCREMENTS OF 50MG/DAY EVERY 3 DAYS UNTIL AN EFFECTIVE DOSE (NOT EXCEEDING 400MG/DAY) WAS REACHED ONCE DAILY DOSING FOR MAINTENANCE ONLY NEW DOSING REGIMEN OF 80MG DAILY PREVENTION OF HEARTBURN SYMPTOMS WHEN ADMINISTERED FROM 15 MINUTES UP TO, BUT NOT INCLUDING, 1 HOUR PRIOR TO A PROVOCATIVE MEAL ADIMISTRATION OF CISATRICURIUM A NEUROMUSCULAR BLOCKING AGENT AT DOSES OF 3 AND 4X THE ED95 OF CISATRICURIUM FOLLOWING INDUCTION WITH THIOPENTAL PEDIATRIC DOSING GUIDELINES INFORMATION FOR USE OF CORVERT IN POST-CARDIAC SURGERY PATIENTS OPTIONAL STARTING DOSE OF 40MG/DAY ALTERNATE DOSING REGIMEN OF 1250MG TWICE DAILY USE IN PEDIATRIC PATIENTS FROM 1 MONTH TO 16 YEARS OF AGE USE OF ZYBAN FOR MAINTENANCE THERAPY. TREATMENT UP TO 6 MONTHS WAS SHOWN EFFICACIOUS ADDITION OF A HIGHER DOSE OF NUTROPIN FOR PUBERTAL PATIENTS (PUBERTAL DOSE LESS THAN OR EQUAL TO 0.7MG/KG/WEEK) ADDITION OF POSTPRANDIAL DOSING 3-HOUR INFUSION OF TAXOL GIVEN EVERY THREE WEEKS AT A DOSE OF 175MG/M2 FOLLOWED BY CISPLATIN AT A DOSE OF 75MG/M2 FOR THE FIRST-LINE TREATMENT OF ADVANCED OVARIAN CANCER CHANGE IN DOSING INTERVAL TO ONCE-DAILY ADMINISTRATION REDUCTION OF ELEVATED LDL-C IN A NEW, HIGHER STRENGTH TABLET, 0.8MG, AND FOR EXTENSION OF THE DOSAGE RANGE TO 0.8MG DAILY ADDITION OF A POST-OPERATIVE DOSING REGIMEN ONCE WEEKLY DOSING FOR THE TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS ONCE WEEKLY DOSING FOR THE PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS TO ALLOW A TITRATION DOSING REGIMEN USING A 25MG DOSE INCREASING DOSAGE FOR NERVE BLOCK ANESTHESIA USING NAROPIN 7.5MG/ML AND FOR EXTENDING THE DURATION OF TREATMENT FOR POSTOPERATIVE ANALGESIA USING NAROPIN 2MG/ML CHANGE DOSING AND ADMINISTRATION TO INDICATE MAINTENANCE OF WEIGHT LOSS OVER AN 18 MONTH PERIOD THUS EXTENDING THE USE OF THIS DRUG FROM ONE TO TWO YEARS DOSING RECOMMENDATIONS FOR PATIENTS UNDERGOING PCI SHORTER TREATMENT COURSE OF THREE DAYS IN THE TREATMENT OF RECURRENT EPISODES OF GENITAL HERPES CHANGE OF ADMIN RATE FOR INFUSION OF AREDIA FOR TREATMENT OF MODERATE AND SEVERE HYPERCALCEMIA OF MALIGNANCY FROM 24 HOURS TO 2 HOURS UP TO BUT NOT INCLUDING 24 HOURS SHORTENED DOSING REGIMEN TO 5 DAYS FOR THE TREATMENT OF ACUTE EXACERBATION OF CHRONIC BRONCHITIS 80MG ONCE DAILY DOSING REGIMEN EIGHT WEEK DOSING REGIMEN INFORMATION REGARDING INCREASED RATE OF INFUSION FOR DEPACON ONCE A WEEK DOSING FOR THE TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS ONCE A WEEK DOSING FOR THE PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS INTERMITTENT DOSING REGIMEN, STARTING DAILY DOSE 14 DAYS PRIOR TO THE ANTICIPATED ONSET OF MENSTRUATION THROUGH THE FIRST FULL DAY OF MENSES AND REPEATING WITH EACH NEW CYCLE FOR USE ON AN "AS NEEDED" OR PRN BASIS FOR THE MANAGEMENT OF NASAL SYMPTOMS IN PATIENTS FOR WHOM THE DRUG IS INDICATED ADDITION OF 20MG AND 40MG DAILY AS OPTIONAL STARTING DOSES WITH 40MG INTENDED FOR PATIENTS WHO REQUIRE A LARGE REDUCTION IN LDL-C (MORE THAN 45%) USE OF FLEXERIL 5MG FOR THE RELIEF OF MUSCLE SPASM ASSOCIATED WITH ACUTE, PAINFUL, MUSCULOSKELETAL CONDITIONS NEW LOWER STARTING DOSE FOR TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS AND/OR MODERATE TO SEVERE SYMPTOMS OF VULVAR AND VAGINAL ATROPHY ASSOCIATED W/ THE MENOPAUSE

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

EXCLUSIVITY DOSING SCHEDULE
D-80 D-81 D-82 D-83 D-84

ADB 3 of 51

D-85 D-86 D-87 D-88 D-89 D-90 D-91 D-92 D-93 D-94 D-95 D-96 D-97

D-98 D-99 D-100 D-101 D-102 D-103

D-104 D-105 D-106

D-107

D-108 D-109

D-110 D-111 D-112 D-113 D-114 D-115 D-116

CHANGE OF DOSING SCHEDULE FOR LANTUS FROM ONCE DAILY AT BEDTIME TO FLEXIBLE DAILY DOSING NEW LOWER STARTING DOSE FOR THE PREVENTION OF POSTMENOPAUSAL OSTEOPORSIS USE OF PREMARIN 0.3 MG AND 0.45 MG FOR THE PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS 750 MG, ONCE DAILY FOR 5 DAYS FOR COMMUNITY ACQUIRED PNEUMONIA (CAP) ONCE-A-DAY DOSING OF FLOXACIN OTIC FOR THE TREATMENT OF ADULTS AND PEDIATRIC PATIENTS(AGES 6 MO & OLDER) W/ OTITIS EXTERNA CAUSED BY SUSCEPTIBLE STRAINS OF E.COLI, P.AERUGINOSA AND S.AUREUS LOWER RECOMMENDED STARTING DOSE GUIDELINES FOR TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH THE MENOPAUSE FOR USE IN SELECT EXTERNAL INSULIN PUMPS ADDITION OF ONCE-WEEKLY DOSING FOR THE TREATMENT TO INCREASE BONE MASS IN MEN WITH OSTEOPOROSIS NEW DOSING RANGE OF 200-400MG PER DAY IN TWO DIVIDED DOSES FOR ADULTS WITH PARTIAL SEIZURES USE OF REYATAZ 300 MG/RITONAVIR 100 MG ONCE DAILY FOR TREATMENT IN HIV-INFECTED ANTIRETROVIRAL-EXPERIENCED PATIENTS ADDITION OF DAYTIME ADMINISTRATION TO TREAT VULVOVAGINAL CANDIDIASIS ALTERNATE INTERMITTENT DOSING REGIMEN ALTERNATIVE DOSAGE OF 1000MG ONCE DAILY AT BEDTIME ALTERNATE TWO OR THREE TIMES DAILY DOSING REGIMENS NEW MAXIMUM DOSAGE OF 72 MG/DAY IN ADOLESCENTS 13-17 YEARS OF AGE WITH ATTENTION DEFECIT HYPERACTIVITY DISORDER (ADHD) BROADENED INITIAL STARTING DOSE FOR HYPERTENSION FROM 50 MG TO 100 MG TO 25 MG TO 100 MG DOSE RANGE ONCE-MONTHLY TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS WITH BONIVA (IBANDRONATE SODIUM) 150 MG TABLETS PED CANCER PT POPULATION EXPANDED TO INCLUDE PTS 6 MOS UP TO BUT NOT INCLUDING 4 YRS AND DOSING INSTRUCTIONS TO ADMIN 30 MIN BEFPRE CHEMO WITH SECOND AND THIRD DOSES 4 & 8 HOURS AFTER FIRST DOSE DOSING FOR PED SURGICAL PTS EXPANDED TO INCLUDE PTS 1 MONTH UP TO BUT NOT INCLUDING 2 YEARS OF AGE ONCE DAILY ADMINISTRATION FOR THE TREATMENT OF HIV INFECTION IN THERAPY NAIVE ADULT PATIENTS 750 MG ONCE DAILY FOR FIVE DAYS FOR THE TREATMENT OF ACUTE BACTERIAL SINUSITIS ONCE DAILY IN CHRONIC IDIOPATHIC UTICARIA FOR ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER NEW DOSING REGIMEN OF ONE SPRAY TWICE DAILY FOR SEASONAL ALLERIC RHINITIS IN PATIENTS 12 YRS OF AGE AND OLDER NEW DOSING RECOMMENDATION FOR THE TREATMENT OF RECURRENT GENITAL HERPES IN IMMUNOCOMPETENT PATIENTS, SPECIFICALLY A REDUCTION IN COURSE OF THERAPY FROM FAMCICLOVIR 125 MG TWICE-A-DAY FOR 5 DAYS TO 1000 MG TWICE-A-DAY FOR 1 DAY. 0.5MG/0.1MG FOR THE TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE IN WOMEN WHO HAVE A UTERUS USE OF ACTONEL 75MG TWO CONSECUTIVE DAYS PER MONTH FOR THE PREVENTION AND TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS FIVE DAY TREATMENT OF SELECTED SUSCEPTIBLE STRAINS OF STREPTOCOCCUS PNEUMONIAE, HAEMOPHILUS INFLUENZA, MYCOPLASMA PNEUMONIAE, AND CHLAMYDIA PNEUMONIAE FOR COMMUNITYACQUIRED PNEUMONIA PROVIDES FOR THE COMBINATION TABLET OF 70MG ALENDRONATE AND 5600 IU OF VITAMIN D3 FOR THE TREATMENT OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN AND TO INCREASE BONE MASS IN MEN WITH OSTEOPOROSIS TREATMENT OF COMPLICATED URINARY TRACT INFECTION AND ACUTE PYELONEPHRITIS WITH LEVAQUIN 750MG ONCE DAILY FOR FIVE DAYS PROVIDE FOR THE USE OF A LOWER DOSE FOR THE TREATMENT OF ADULTS WITH CHRONIC PHASE CHRONIC MYELOID LEUKEMIA (CML) WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY INCLUDING IMATINIB MESYLATE TREATMENT OF SCHIZOPHRENIA IN ADOLESCENTS AGED 13-17 PROVIDES FOR ONCE DAILY USE OF CIALIS, 2.5 MG AND 5 MG, FOR THE TREAMTENT OF ERECTILE DYSFUNCTION PROVIDES FOR PEDIATRIC PUMP USE ONCE DAILY DOSING REGIMEN FOR PATIENTS WHO BECOME CONSTIPATED ON TWICE DAILY REGIMEN NEW DOSING RECOMMENDATIONS FOR USE OF SIROLIMUS IN COMBINATION WITH CYCLOSPORINE FOR THE PROPHYLAXIS OF REJECTION IN HIGH-RISK RENAL TRANSPLANT RECIPIENTS STARTING DOSE OF 15MG/DAY FOR MONOTHERAPY IN ACUTE TREATMENT OF BIPOLAR DISORDER, MANIC OR MIXED ALTERNATIVE DOSING REGIMEN ATAZANAVIR SULATE CO-ADMINISTERED WITH RITONAVIR FOR THE TREATMENT OF HIV-1 INFECTION IN TREATMENT NAIVE PATIENTS

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

EXCLUSIVITY DOSING SCHEDULE
D-117 D-118 D-119 D-120 D-121 D-122 D-123 D-124 D-125

ADB 4 of 51

D-126 D-127 D-128

D-129 D-130

D-131 D-132 D-133

50 MG TABLET FOR INITIATION OF DOSE TITRATION FOR BIPOLAR DISORDER TWO 400MG TABLETS ONCE DAILY, CO-ADMINISTERED WITH 100MG RITONAVIR DOSING RECOMMENDATIONS FOR HIV INFECTED PEDIATRIC PATIENTS 6 TO LESS THAN 18 YEARS OF AGE DOSING REGIMEN ADJUSTMENTS CHANGE TO REMOVE 20 MG MAXIMUM DOSAGE RESTRICTION USE OF VAGIFEM 10 MCG FOR THE TREATMENT OF ATROPHIC VAGINITIS DUE TO MENOPAUSE ALTERNATIVE DOSING REGIMEN DOSE OF 20 MG/METER SQUARE BY CONTINUOUS INTRAVENOUS INFUSION OVER 1 HOUR REPEATED DAILY FOR 5 DAYS ONCE DAILY DOSING REGIMEN IN ADULT PATIENTS WITH LESS THAN THREE LOPINAVIR RESISTANCEASSOCIATED SUBSTITUTIONS EXTEND CURRENT DOSING REGIMEN TO 900MG (2-450MG TABLETS) ONCE A DAY WITHIN 10 DAYS OF TRANSPLANTATION UNTIL 200 DAYS POST-TRANSPLANTATION FOR THE PREVENTION OF CYTOMEGALOVIRUS (CMV) DISEASE IN ADULT KIDNEY TRANSPLANT PATIENTS AT HIGH RISK. CHANGE DOSAGE REGIMEN FROM 250MG TO 500MG DOSING REGIMEN FOR ADULT PATIENTS WITH CHRONIC HEPATITIS B (CHB) AND DECOMPENSATED LIVER DESEASE SINGLE IV DOSE OF FOSAPREPITANT 150MG, DOSED CONCOMITANTLY WITH 5HT3 RECEPTOR ANTAGONIST & CORTICOSTEROID, FOR PREVENTION OF ACUTE & DELAYED NAUSEA & VOMITING ASSOCIATED WITH INITIAL AND REPEAT COURSES OF HIGHLY EMETOGENIC CANCER CHEMO 800/100 MG DARUNAVIR/RITONAVIR, ONCE DAILY, IN TREATMENT -EXPERIENCED HIV-1 INFECTED PATIENTS WITH NO DARUNIVIR RESISTANCE ASSOCIATED SUBSITUTIONS DOSING RECOMMENDATIONS FOR TREATMENT OF HIV-1 INFECTION DURING PREGNANCY BASED ON DATA FROM STUDY AI424-182, A STUDY OF ATAZANAVIR/RITONAVIR IN COMBINATION WITH ZIDOVUDINE/LAMIVUDINE IN HIV INFECTED PREGNANT WOMEN EVERY 6 TO 8 WEEKS FOR THE 120MG STRENGTH FOR PATIENTS WHO ARE CONTROLLED ON SOMATULINE DEPOT 60MG OR 90MG 45MG FOR 6 MONTH ADMINISTRATION NEW EFFICACY DATA AND DOSING REGIMEN FOR PREGNANCY IN NORMAL OVULATORY WOMEN UNDERGOING CONTROLLED OVARIAN STIMULATION AS PART OF AN IVF OR INTRACYTOPLASMIC SPERM INJECTION (ICSI) CYCLE

EXCLUSIVITY INDICATION
I-1 I-2 I-3 I-4 I-5 I-6 I-7 I-8 I-9 I-10 I-11 I-12 I-13 I-14 I-15 I-16 I-17 I-18 I-19 I-20 I-21 DYSMENORRHEA CHOLANGIOPANCREATOGRAPHY INTRAVENOUS DIGITAL SUBTRACTION ANGIOGRAPHY PERIPHERAL VENOGRAPHY (PHLEBOGRAPHY) HYSTEROSALPINGOGRAPHY TREATMENT OF JUVENILE ARTHRITIS BIOPSY PROVEN MINIMAL CHANGE NEPHROTIC SYNDROME IN CHILDREN ADULT INTRAVENOUS CONTRAST-ENHANCED COMPUTED TOMOGRAPHY OF THE HEAD AND BODY PREVENTION OF POSTOPERATIVE NAUSEA AND VOMITING PREVENTION OF POSTOPERATIVE DEEP VENOUS THROMBOSIS AND PULMONARY EMBOLISM IN TOTAL HIP REPLACEMENT SURGERY RELIEF OF MILD TO MODERATE PAIN TREATMENT OF CUTANEOUS CANDIDIASIS URINARY TRACT INFECTION (UTI) PREVENTION FOR PERIODS UP TO FIVE MONTHS IN WOMEN WITH A HISTORY OF RECURRENT UTI SEBORRHEIC DERMATITIS PHOTOPHERESIS IN THE PALLIATIVE TREATMENT OF SKIN MANIFESTATIONS OF CUTANEOUS T-CELL LYMPHOMA IN PERSONS NOT RESPONSIVE TO OTHER TREATMENT STIMULATE THE DEVELOPMENT OF MULTIPLE FOLLICLES/OOCYTES IN OVULATORY PATIENTS PARTICIPATING IN AN IN VITRO FERTILIZATION PROGRAM MANAGEMENT OF CONGESTIVE HEART FAILURE ENDOSCOPIC RETROGRADE PANCREATOGRAPHY HERNIOGRAPHY KNEE ARTHROGRAPHY HIGH DOSE METHOTREXATE WITH LEUCOVORIN RESCUE IN COMBINATION WITH OTHER CHEMOTHERAPEUTIC AGENTS TO DELAY RECURRENCE IN PATIENTS WITH NONMETASTATIC OSTEOSARCOMA WHO HAVE UNDERGONE SURGICAL RESECTION OR AMPUTATION FOR THE PRIMARY TUMOR RESCUE AFTER HIGH-DOSE METHOTREXATE THERAPY IN OSTEOSARCOMA SHORT-TERM TREATMENT OF ACTIVE BENIGN GASTRIC ULCER TREATMENT OF RHEUMATOID ARTHRITIS ADULT INTRA-ARTERIAL DIGITAL SUBTRACTION ANGIOGRAPHY OF THE HEAD, NECK, ABDOMINAL, RENAL AND PERIPHERAL VESSELS

I-22 I-23 I-24 I-25

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

EXCLUSIVITY INDICATION
I-26 I-27 I-28 I-29 I-30 I-31 I-32 I-33 I-34 I-35 I-36 I-37 I-38 I-39 I-40 I-41 I-42 I-43 I-44 I-45 I-46 I-47 I-48 I-49 I-50 I-51 I-52 I-53 I-54 I-55 I-56 I-57 I-58 I-59 I-60 I-61 I-62 I-63 I-64 I-65 I-66 I-67 I-68 I-69

ADB 5 of 51

I-70 I-71 I-72 I-73 I-74 I-75 I-76

TREATMENT OF LIVER FLUKES ADJUNCTIVE THERAPY TO DIET TO REDUCE THE RISK OF CORONARY ARTERY DISEASE SELECTIVE ADULT VISCERAL ARTERIOGRAPHY METASTATIC BREAST CANCER IN PREMENOPAUSAL WOMEN AS AN ALTERNATIVE TO OOPHORECTOMY OR OVARIAN IRRADIATION TREATMENT OF TINEA PEDIS CONTRAST ENHANCEMENT AGENT TO FACILITATE VISUALIZATION OF LESIONS IN THE SPINE AND ASSOCIATED TISSUES PEDIATRIC MYELOGRAPHY ORAL USE OF DILUTED OMNIPAQUE INJECTION IN ADULTS FOR CONTRAST ENHANCED COMPUTED TOMOGRAPHY OF THE ABDOMEN ORAL USE IN ADULTS FOR PASS-THROUGH EXAMINATION OF THE GASTROINTESTINAL TRACT PEDIATRIC CONTRAST ENHANCEMENT OF COMPUTED TOMOGRAPHIC HEAD IMAGING ARTHROGRAPHY OF THE SHOULDER JOINTS IN ADULTS RADIOGRAPHY OF THE TEMPOROMANDIBULAR JOINT IN ADULTS CONTRAST ENHANCEMENT AGENT TO FACILITATE VISUALIZATION OF LESIONS OF THE CENTRAL NERVOUS SYSTEM IN CHILDREN (2 YEARS OF AGE AND OLDER) TREATMENT OF ACUTE MYOCARDIAL INFARCTION PRIMARY NOCTURNAL ENURESIS MIGRAINE HEADACHE PROPHYLAXIS HERPES ZOSTER HERPES SIMPLEX ENCEPHALITIS MAINTENANCE THERAPY IN HEALED DUODENAL ULCER PATIENTS AT DOSE OF 1 GRAM TWICE DAILY ACUTE TREATMENT OF VARICELLA ZOSTER VIRUS USE IN PEDIATRIC COMPUTED TOMOGRAPHIC HEAD AND BODY IMAGING TREATMENT OF PEDIATRIC PATIENTS WITH SYMPTOMATIC HUMAN IMMUNODEFICIENCY VIRUS (HIV) DISEASE PEDIATRIC ANGIOCARDIOGRAPHY TREATMENT OF TRAVELERS' DIARRHEA DUE TO SUSCEPTIBLE STRAINS OF ENTEROTOXIGENIC ESCHERICHIA COLI FOR USE IN WOMEN WITH AXILLARY NODE-NEGATIVE BREAST CANCER TREATMENT OF PRIMARY DYSMENORRHEA AND FOR THE TREATMENT OF IDIOPATHIC HEAVY MENSTRUAL BLOOD LOSS PEDIATRIC EXCRETORY UROGRAPHY TREATMENT OF PANIC DISORDER, WITH OR WITHOUT AGORAPHOBIA RENAL CONCENTRATION CAPACITY TEST HYPERTENSION EROSIVE GASTROESOPHAGEAL REFLUX DISEASE SHORT-TERM TREATMENT OF ACTIVE DUODENAL ULCER INITIAL TREATMENT OF ADVANCED OVARIAN CARCINOMA IN COMBINATION WITH OTHER APPROVED CHEMOTHERAPEUTIC AGENTS ENDOSCOPICALLY DIAGNOSED ESOPHAGITIS, INCLUDING EROSIVE AND ULCERATIVE ESOPHAGITIS, AND ASSOCIATED HEARTBURN DUE TO GASTROESOPHAGEAL REFLUX DISEASE SINGLE APPLICATION TREATMENT OF HEAD LICE IN CHILDREN TWO MONTHS TO TWO YEARS IN AGE FEMALE ANDROGENETIC ALOPECIA PREVENTION AND TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS ONCE DAILY TREATMENT AS INITIAL THERAPY IN THE TREATMENT OF HYPERTENSION PREVENTION OF SUPRAVENTRICULAR TACHYCARDIAS PREVENTION OF UPPER GASTROINTESTINAL BLEEDING IN CRITICALLY ILL PATIENTS UNCOMPLICATED GONORRHEA TREATMENT OF ACUTE ASTHMATIC ATTACKS IN CHILDREN SIX YEARS OF AGE AND OLDER CENTRAL PRECOCIOUS PUBERTY SHORT TERM TREATMENT OF PATIENTS WITH SYMPTOMS OF GASTROESOPHAGEAL REFLUX DISEASE (GERD), AND FOR THE SHORT TERM TREATMENT OF ESOPHAGITIS DUE TO GERD INCLUDING ULCERATIVE DISEASE DIAGNOSED BY ENDOSCOPY USE IN COMBINATION WITH 5-FLUOROURACIL TO PROLONG SURVIVAL IN THE PALLIATIVE TREATMENT OF PATIENTS WITH ADVANCED COLORECTAL CANCER VARICELLA INFECTIONS (CHICKENPOX) PREVENTION OF CMV DISEASE IN TRANSPLANT PATIENTS AT RISK FOR CMV DISEASE INITIATE AND MAINTAIN MONITORED ANESTHESIA CARE (MAC) SEDATION DURING DIAGNOSTIC PROCEDURES INTRAVENOUS DIGITAL SUBTRACTION ANGIOGRAPHY TREATMENT OF ENDOSCOPICALLY DIAGNOSED EROSIVE ESOPHAGITIS PREVENTION OF OSTEOPOROSIS

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

EXCLUSIVITY INDICATION
I-77 I-78 I-79 I-80 I-81 I-82 I-83 I-84 I-85 I-86 I-87 I-88 I-89 I-90 I-91 I-92 I-93 I-94 I-95 I-96 I-97 I-98 I-99 I-100 I-101 I-102 I-103

ADB 6 of 51

I-104 I-105 I-106 I-107 I-108 I-109 I-110 I-111 I-112 I-113 I-114 I-115 I-116 I-117 I-118 I-119 I-120 I-121 I-122 I-123 I-124

DERMAL INFECTIONS-TINEA PEDIS, TINEA CORPORIS, TINEA CRURIS DUE TO EPIDERMOPHYTON FLOCCOSUM CONTRAST ENHANCED COMPUTED TOMOGRAPHIC IMAGING OF THE HEAD AND BODY AND INTRAVENOUS EXCRETORY UROGRAPHY MANAGEMENT OF CHRONIC STABLE ANGINA AND ANGINA DUE TO CORONARY ARTERY SPASM DIAGNOSIS AND LOCALIZATION OF ISCHEMIA AND CORONARY HEART DISEASE PROPHYLAXIS IN DESIGNATED IMMUNOCOMPROMISED CONDITIONS TO REDUCE THE INCIDENCE OF OROPHARYNGEAL CANDIDIASIS TREATMENT OF TRAVELERS' DIARRHEA ANGIOCARDIOGRAPHY, CONTRAST ENHANCED COMPUTED TOMOGRAPHIC IMAGING OF THE HEAD AND BODY, AND INTRAVENOUS EXCRETORY UROGRAPHY IN CHILDREN INTRAOPERATIVE AND POSTOPERATIVE TACHYCARDIA AND/OR HYPERTENSION TREATMENT OF ANOREXIA ASSOCIATED WITH WEIGHT LOSS IN PATIENTS WITH AIDS TREATMENT OF SECONDARY CARNITINE DEFICIENCY RENAL IMAGING AGENT FOR USE IN CHILDREN MANAGEMENT OF ENDOMETRIOSIS EPIDURAL USE IN LABOR AND DELIVERY AS AN ANALGESIC ADJUNCT TO BUPIVACAINE INTENSIVE CARE UNIT SEDATION MONOTHERAPY USE FOR HYPERTENSION ADJUNCTIVE THERAPY IN THE MANAGEMENT OF HEART FAILURE PREVENTION OF EXERCISE-INDUCED BRONCHOSPASM IN CHILDREN AGES 4-11 YEARS USE WITH MRI IN ADULTS TO PROVIDE CONTRAST ENHANCEMENT AND FACILITATE VISUALIZATION OF LESIONS IN THE BODY [EXCLUDING THE HEART] TREATMENT OF LEFT VENTRICULAR DYSFUNCTION FOLLOWING MYOCARDIAL INFARCTION TREATMENT OF SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA ORAL OR RECTAL USE IN CHILDREN FOR THE EXAMINATION OF THE GASTROINTESTINAL TRACT TREATMENT OF CHILDREN WHO HAVE GROWTH FAILURE ASSOCIATED WITH CHRONIC RENAL INSUFFICIENCY PEDIATRIC ANESTHESIA IN CHILDREN 3 YEARS AND OLDER TO DECREASE THE INCIDENCE OF CANDIDIASIS IN PATIENTS UNDERGOING BONE MARROW TRANSPLANTATION WHO RECEIVE CYTOTOXIC CHEMOTHERAPY AND/OR RADIATION THERAPY TREATMENT OF DIABETIC NEPHROPATHY IN PATIENTS WITH TYPE I INSULIN-DEPENDENT DIABETES MELLITUS AND RETINOPATHY TREATMENT OF OBSESSIVE-COMPULSIVE DISORDER PROPHYLAXIS AGAINST PNEUMOCYSTIS CARINII PNEUMONIA IN INDIVIDUALS WHO ARE IMMUNOCOMPROMISED AND CONSIDERED TO BE AT RISK OF DEVELOPING PNEUMOCYSTIS CARINII PNEUMONIA TREATMENT OF PULMONARY AND EXTRAPULMONARY ASPERGILLOSIS IN PATENTS WHO ARE INTOLERANT OF OR WHO ARE REFRACTORY TO AMPHOTERICIN B THERAPY TREATMENT OF METASTATIC CARCINOMA OF THE BREAST AFTER FAILURE OF FIRST-LINE OR SUBSEQUENT CHEMOTHERAPY TREATMENT OF ACROMEGALY VAGINAL CANDIDIASIS EXPANDED USE-FOR ICU PATIENTS UNDERGOING LONG-TERM INFUSION DURING MECHANICAL VENTILATION TYPHOID FEVER PREVENTION OF NAUSEA AND VOMITING ASSOCIATED WITH RADIOTHERAPY TREATMENT OF PAGET'S DISEASE OF BONE MANAGEMENT OF MODERATE TO SEVERE PAIN TREATMENT OF PROSTATITIS USE IN CHILDREN TO VISUALIZE LESIONS WITH ABNORMAL VASCULARITY IN THE BRAIN (INTRACRANIAL LESIONS), SPINE, AND ASSOCIATED TISSUE USE IN MRI IN ADULTS TO VISUALIZE LESIONS IN THE HEAD AND NECK MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS TO SLOW THE PROGRESSION FO CORONANY ATHEROSCLEROSIS IN PATIENTS WITH CORONARY HEART DISEASE PREVENTION OF DEEP VEIN THROMBOSIS, WHICH MAY LEAD TO PULMONARY EMBOLISM FOLLOWING KNEE REPLACEMENT SURGERY TREATMENT OF ANEMIA CAUSED BY UTERINE LEIOMYOMATA IN WOMEN WHO FAIL IRON THERAPY MAINTENANCE THERAPY FOR GASTRIC ULCER PATIENTS AT REDUCED DOSAGE AFTER HEALING ACUTE ULCERS EXPANDED PATIENT POPULATION -- USE IN ICU PATIENTS PSORIASIS OF THE SCALP RELIEF OF MILD TO MODERATE PAIN IN PATIENTS AGED 6 MONTHS AND OLDER LEUCOCYTE LABELED SCINTIGRAPHY AS AN ADJUNCT IN THE LOCALIZATION OF INTRA-ABDOMINAL INFECTION AND INFLAMMATORY BOWEL DISEASE

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

EXCLUSIVITY INDICATION
I-125 I-126 I-127 I-128

ADB 7 of 51

I-129 I-130 I-131 I-132 I-133 I-134 I-135 I-136 I-137 I-138 I-139 I-140 I-141 I-142 I-143 I-144 I-145 I-146 I-147 I-148 I-149 I-150 I-151 I-152 I-153 I-154 I-155 I-156 I-157 I-158 I-159

I-160 I-161 I-162 I-163 I-164 I-165

I-166 I-167 I-168 I-169 I-170 I-171

EXPANSION OF CONSCIOUS SEDATION INDICATION TO INCLUDE SHORT THERAPEUTIC PROCEDURES ADJUNCT TO THALLIUM- 201 MYOCARDIAL PERFUSION IN PATIENTS UNABLE TO EXERCISE ADEQUATELY TREATMENT OF ACYCLOVIR-RESISTANT HERPES IN IMMUNOCOMPROMISED PATIENTS IN PT W/ CH DISEASE AND HYPERCHOLESTEROLEMIA: REDUCE RISK TOTAL MORTALITY BY REDUCING CORONARY DEATH; REDUCE RISK NON-FATAL MI; REDUCE RISK UNDERGOING MYOCARDIAL REVASCULARIZATION PROCEDURES; REDUCTION ELEVATED TOTAL AND LDL CHOL LEVELS... TREATMENT OF ALCOHOL DEPENDENCE MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS PERIPHERAL ARTERIOGRAPHY TREATMENT OF MANIC PHASE OF BIPOLAR DISORDER MANAGEMENT OF CHRONIC STABLE ANGINA HEART FAILURE POST MYOCARDIAL INFARCTION BONE METASTASES ASSOCIATED WITH MULTIPLE MYELOMA IDIOPATHIC CHRONIC URTICARIA PREVENTION OF METAL-INDUCED HEART BURN, ACID INDIGESTION, AND SOUR STOMACH WHEN TAKEN 30 MINUTES PRIOR TO CONSUMING FOOD OR BEVERAGES TREATMENT OF ACUTE RECURRENT GENITAL HERPES PALLIATIVE TREATMENT OF ADVANCED BREAST CANCER IN PRE- AND PERIMENOPAUSAL WOMEN PREVENTION OF CYTOMEGALOVIRUS (CMV) DISEASE IN INDIVIDUALS WITH HIV INFECTION AT RISK FOR DEVELOPING CMV DISEASE TREATMENT OF HEMODYNAMICALLY STABLE PATIENTS WITHIN 24 HOURS OF ACUTE MYOCARDIAL INFARCTION TO IMPROVE SURVIVAL LOCALIZE MYOCARDIAL ISCHEMIA(REVERSIBLE DEFECT) AND INFARCTION (NON-REVERSIBLE DEFECTS) IN EVALUATING MYOCARDIAL FUNCTION EPISODIC TREATMENT OF RECURRENT GENITAL HERPES IN IMMUNOCOMPETENT ADULTS ENHANCEMENT OF MRI OF THE ADULT BODY INTERNAL ORGANS 0.1MMOL/KG AS A SINGLE INTRAVEOUS BOLUS FOR MRI OF THE CNS IN CHILDREN CONTRAST ENHANCEMENT AND FACILITATION OF VISUALIZATION OF EXTRACRANIAL HEAD AND NECK LESIONS PREVENTION OF GALLSTONE FORMATION IN OBESE PATIENTS EXPERIENCING RAPID WEIGHT LOSS TREATMENT OF ACUTE PNEUMOCYSTIC CARINI PNEUMONIA (PCP) IN HIV-INFECTED PATIENTS WHOSE ALVEOLAR-ARTERIAL OXYGEN DIFFERENCE (AaDO2) IS LESS THAN OR EQUAL TO 55 TORR TREATMENT OF PATIENTS WITH NON-SMALL CELL LUNG CANCER TREATMENT OF OBSESSIVE COMPULSIVE DISORDER AND PANIC DISORDER PREVENTION OF AND PREVENTION OF FURTHER POSTOPERATIVE NAUSEA AND VOMITING IN PEDIATRIC PATIENTS RECEIVING GENERAL ANESTHESIA SLOWING THE PROGRESSION OF CORONARY ATHEROSCLEROSIS AND REDUCING THE RISK OF ACUTE CORONARY EVENTS MANAGEMENT OF SEVERE SPASTICITY [ENCOMPASES SPINAL AND CEREBRAL ORIGIN] PATIENT POPULATION ALTERED TO INCLUDE PEDIATRIC USE TREATMENT OF ONCHOMYCOSIS DUE TO DERMATOPHYTES (TINEA UNGUIUM) OF THE TOENAIL WITH OR WITHOUT FINGERNAIL INVOLVEMENT ADDITIONAL DATA REGARDING THE SAFE USE OF NORVASC IN PATIENTS WITH HEART FAILURE TREATMENT OF ACUTE UNCOMPLICATED CYSTITIS IN FEMALES TREATMENT OF OSTEOLYTIC BONE METASTASES OF BREAST CANCER FOR HYPERCHOLESTEROLEMIC PATIENTS WITHOUT CLINICALLY EVIDENT HEART DISEASE REDUCE THE RISK OF MYOCARDIAL INFARCTION, REVASCULARIZATION, AND DEATH DUE TO CARDIOVASCULAR CAUSES WITH NO INCREASE IN DEATH FROM NON-CARDIOVASCULAR CAUSES TREATMENT OF BACTERIAL CORNEAL ULCERS TREATMENT OF ADULT-ONSET OR CHILDHOOD-ONSET ADULT GROWTH HORMONE DEFICIENCY FOR USE IN PATIENTS 6-11 YEARS OF AGE TREATMENT OF PHOTOPHOBIA CHRONIC BACTERIAL PROSTATITIS MANAGEMENT OF ADULTS WITH ACTIVE, CLASSIC AND DEFINITIVE RHEUMATOID ARTHRITIS WHO HAVE HAD INSUFFICIENT THERAPEUTIC RESPONSE TO OR ARE INTOLERANT OF AN ADEQUATE TRIAL OF FULL DOSES OF ONE OR MORE NON-STEROIDAL ANTI-INFLAMMATORY DRUGS TREATMENT OF BULIMIA COMPLICATED INTRA-ABDOMINAL INFECTIONS (USED IN COMBINATION WITH METRONIDAZOLE) CAUSED BY MIXED AEROBIC/ANAEROBIC PATHOGENS MANAGEMENT OF LOCALLY CONFINED STAGE B2-C METASTATIC CARCINOMA OF THE PROSTATE (IN COMBINATION WITH LHRH AGONISTS) USE IN COMBINATION WITH CORTICOSTEROIDS AS INITIAL CHEMOTHERAPY FOR THE TREATMENT OF PATIENTS WITH PAIN RELATED TO ADVANCED HORMONE-REFRACTORY PROSTATE CANCER PROPHYLACTIC USE DURING HEAD LICE EPIDEMICS RELIEF OF SYMPTOMS OF THE COMMON COLD

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

EXCLUSIVITY INDICATION
I-172 I-173 I-174 I-175 I-176 I-177

ADB 8 of 51

I-178 I-179 I-180 I-181 I-182 I-183 I-184 I-185 I-186 I-187 I-188 I-189 I-190

I-191 I-192

I-193 I-194 I-195

I-196 I-197 I-198

I-199 I-200 I-201 I-202 I-203 I-204 I-205 I-206 I-207 I-208 I-209 I-210

I-211 I-212 I-213 I-214

TREATMENT OF INITIAL EPISODE OF GENITAL HERPES PREOPERATIVELY FOR THE PREVENTION OF INFECTION IN TRANSRECTAL PROSTATE BIOPSY PELVIC INFLAMMATORY DISEASE TREATMENT OF TINEA CORPORIS AND TINEA CRURIS TREATMENT OF POSTOPERATIVE INFLAMMATION IN PATIENTS WHO HAVE UNDERGONE CATARACT EXTRACTION TX OF MODERATE ACNE VULGARIS IN FEMALES,GREATER OR EQUAL TO 15YRS OF AGE,WHO HAVE NO KNOWN CONTRAINDICATIONS TO ORAL CONTRACEPTIVE THERAPY,DESIRE CONTRACEPTION,HAVE ACHIEVED MENARCHE AND ARE UNRESPONSIVE TO TOPICAL ANTI-ACNE MEDICATIONS TREATMENT OF ONCHOMYCOSIS OF THE FINGERNAIL WITHOUT CONCOMITANT ONCHOMYCOSIS OF THE TOENAIL WITH A PULSE DOSING REGIMEN NOSOCOMIAL PNEUMONIA-MILD TO MODERATE AND SEVERE CAUSED BY HAEMOPHILUS INFLUENZAE OR KLEBSIELLA PNEUMONIAE TREATMENT OF PLANTAR TINEA PEDIS (MOCCASIN TYPE) TREATMENT OF PATIENTS WITH COMPLEX PARTIAL SEIZURES WITH AND WITHOUT SECONDARY GENERALIZATION TREATMENT OF GROWTH FAILURE ASSOCIATED WITH TURNER SYNDROME MAINTENANCE THERAPY IN THE MANAGEMENT OF MILD TO MODERATE ASTHMA IN PEDIATRIC PATIENTS AGES 6-11 TREATMENT OF PANIC DISORDER AT A RECOMMENDED DOSE RANGE OF 1 TO 2MG/DAY (MAXIMUM OF 4MG) PREVENTION OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN TREATMENT OF TINEA (PITYRIASIS) VERSICOLOR CAUSED BY OR PRESUMED TO BE CAUSED BY PITYROSPORUM ORBICULARE (ALSO KNOWN AS MALASSEZIA FURFUR OR M. ORBICULARE) PREVENTION OF FRACTURES IN THE TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS TREATMENT OF ACUTE SINUSITIS AND ACUTE EXACERBATION OF CHRONIC SINUSITIS TREATMENT OF ACUTE OTITIS MEDIA IN PEDIATRIC PATIENTS PLANAR IMAGING AS A SECOND LINE DIAGNOSTIC DRUG AFTER MAMMOGRAPHY TO ASSIST IN THE EVALUATION OF BREAST LESIONS IN PATIENTS WITH AN ABNORMAL MAMMOGRAM OR A PALPABLE BREAST MASS ENDOMETRIAL THINNING AGENT PRIOR TO ENDOMETRIAL ABLATION FOR DYSFUNCTIONAL UTERINE BLEEDING THE PREVENTION OF DEEP VEIN THROMBOSIS, WHICH MAY LEAD TO PULMONARY EMBOLISM, IN PATIENTS UNDERGOING ABDOMINAL SURGERY WHO ARE AT RISK FOR THROMBOEMBOLIC COMPLICATIONS AND A NEW DOSAGE REGIMEN, 40MG ONCE DAILY, FOR THIS INDICATION TREATMENT OF PANIC DISORDER IN A RECOMMENDED DOSE RANGE OF 50 TO 200MG/DAY CONGESTIVE HEART FAILURE FOR USE OF LANSOPRAZOLE IN COMBINATION WITH CLARITHROMYCIN AND AMOXICILLIN FOR THE ERADICATION OF HELICOBACTER PYLORI IN PATIENTS WITH ACTIVE DUODENAL ULCER DISEASE OR A ONE-YEAR HISTORY OF DUODENAL ULCER ACUTE TREATMENT OF ACTIVE BENIGN GASTRIC ULCER MAINTENANCE OF HEALING OF DUODENAL ULCER FOR THE USE OF LANSOPRAZOLE IN COMBINATION WITH AMOXICILLIN FOR THE ERADICATION OF HELICOBACTER PYLORI IN PATIENTS WITH ACTIVE DUODENAL ULCER DISEASE OR A ONE-YEAR HISTORY OF A DUODENAL ULCER MONOTHERAPY AND COMBINATION THERAPY WITH SULFONYL UREAS IN THE TREATMENT OF TYPE II DIABETES TREATMENT OF TINEA (PITYRIASIS) VERSICOLOR EMPIRICAL THERAPY FOR FEBRILE NEUTROPENIC PATIENTS SECOND-LINE TREAMENT OF AIDS-RELATED KAPOSI'S SARCOMA MAINTENANCE OF REMISSION OF ULCERATIVE COLITIS USE IN PEDIATRIC PATIENTS BETWEEN THE AGES OF 6 AND 11 FOR THE TREATMENT OF THE NASAL SYMPTOMS OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS INITIAL ANTICONVULSANT TREATMENT OF STATUS EPILEPTICUS TREATMENT OF EDEMA ASSOCIATED WITH CHRONIC RENAL FAILURE FOR THE SUPPRESSION OF RECURRENT EPISODES OF GENITAL HERPES IN IMMUNOCOMPETENT ADULTS TREATMENT OF OBSESSIVE COMPULSIVE DISORDER IN THE PEDIATRIC POPULATION PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA (PSVT) TO SLOW THE PROGRESSION OF CORONARY ATHEROSCLEROSIS IN PATIENTS WITH CORONARY HEART DISEASE AS PART OF A TREATMENT STRATEGY TO LOWER TOTAL AND LDL CHOLESTEROL TO TARGET LEVELS FOR USE IN PEDIATRIC POPULATION TREATMENT OF SYMPTOMS OF DRY MOUTH IN PATIENTS WITH SJOGREN'S SYNDROME TEMPORARY RELIEF OF PAIN AND PHOTOPHOBIA IN PATIENTS UNDERGOING CORNEAL REFRACTIVE SURGERY TREATMENT OF OSTEOPOROSIS

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

EXCLUSIVITY INDICATION
I-215 I-216

ADB 9 of 51

I-217 I-218 I-219 I-220 I-221

I-222 I-223 I-224 I-225 I-226 I-227 I-228 I-229 I-230

I-231 I-232 I-233

I-234

I-235 I-236 I-237 I-238 I-239 I-240

I-241

I-242 I-243 I-244 I-245 I-246 I-247 I-248

PRE-PROCEDURAL APPLICATION TO ADULT MALE GENITAL SKIN PRIOR TO SITE-SPECIFIC SUBCUTANEOUS INFILTRATION WITH LIDOCAINE FOR THE REMOVAL OF GENITAL WARTS FOR THE LONG-TERM TWICE-DAILY (MORNING AND EVENING) ADMINISTRATION IN THE MAINTENANCE TREATMENT OF BRONCHOSPASM ASSOCIATED WITH COPD, INCLUDING CHRONIC BRONCHITIS AND EMPHYSEMA PREVENTION (DURING AND FOLLOWING HOSPITALIZATION) OF DEEP VEIN THROMBOSIS, WHICH MAY LEAD TO PULMONARY EMBOLISM, IN PATIENTS UNDERGOING HIP REPLACEMENT SURGERY USE OF LIPITOR AS AN ADJUNCTIVE THERAPY TO DIET FOR THE TREATMENT OF PATIENTS WITH ELEVATED SERUM TRIGLYCERIDE LEVELS (FREDERICKSON TYPE IV) USE OF LIPITOR BY PATIENTS WITH PRIMARY DYSBETALIPOPROTEINEMIA (FREDERICKSON TYPE III) WHO DO NOT RESPOND ADEQUATELY TO DIET TREATMENT OF EPISODIC- HEARTBURN, ACID INDIGESTION AND SOUR STOMACH TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH) IN MEN WITH AN ENLARGED PROSTATE TO IMPROVE SYMPTOMS, REDUCE THE RISK OF ACUTE URINARY RETENTION AND REDUCE THE RISK OF THE NEED OF SURGERY PREVENTION OF ISCHEMIC COMPLICATIONS OF UNSTABLE ANGINA AND NON-Q-WAVE MYOCARDIAL INFARCTION, WHEN CONCURRENTLY ADMINISTERED WITH ASPIRIN USE IN THE SYMPTOMATIC RELIEF OF RHINORRHEA ASSOCIATED WITH ALLERGIC AND NONALLERGICPERENNIAL RHINITIS IN CHILDREN AGE 6-11 YEARS FOR THE USE IN PEDIATRIC PATIENTS 4 TO 11 YEARS OF AGE FOR THE MANAGEMENT OF THE NASAL SYMPTOMS OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS USE IN PATIENTS WITH PREVIOUS MI AND NORMAL CHOLESTEROL LEVELS, TO REDUCE RISK OF RECURRENT MI, MYOCARDIAL REVASCULARIZATION, AND CEREBROVASCULAR DISEASE EVENTS FIRST-LINE THERAPY FOR THE TREATMENT OF ADVANCED CARCINOMA OF THE OVARY IN COMBINATION WITH CISPLATIN SHORT-TERM TREATMENT OF SYMPTOMATIC GASTROESPHAGEAL REFLUX DISEASE (GERD) PREVENTION OF MEAL INDUCED HEARTBURN AT A DOSE OF 75MG TAKEN 30-60MIN PRIOR TO A MEAL PRILOSEC (OMEPRAZOLE), AMOXICILLIN, AND CLARITHROMYCIN FOR THE ERADICATION OF H. PYLORI IN PATIENTS WITH DUODENAL ULCER DISEASE IN COMBINATION WITH CIS-PLATIN, FOR THE FIRST LINE TREATMENT OF NON-SMALL CELL LUNG CANCER IN PATIENTS WHO ARE NOT CANDIDATES FOR POTENTIALLY CURATIVE SURGERY AND/OR RADIATION TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC BREAST CANCER AFTER FAILURE OF PRIOR CHEMOTHERAPY TREATMENT OF RECURRENT MUCOCUTANEOUS HERPES SIMPLEX INFECTIONS IN HIV-AFFECTED PATIENTS AT A DOSE OF 500MG TWICE DAILY PROPHYLACTIC USE TO REDUCE PERIOPERATIVE BLOOD LOSS AND THE NEED FOR BLOOD TRANSUFSION IN PATIENTS UNDERGOING CARDIOPULMONARY BYPASS IN THE COURSE OF CORONARY ARTERY BYPASS GRAFT SURGERY FOR USE IN COMBINATION WITH CISPLATIN FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH INOPERABLE LOCALLY ADVANCED (STAGE IIIA OR IIIB) OR METASTATIC (STAGE IV) NON-SMALL CELL LUNG CANCER PREVENTION OF EXERCISE-INDUCED BRONCHOSPASM IN PATIENTS 12 YEARS OF AGE AND OLDER PREVENTION OF EXERCISE-INDUCED BRONCHOSPASM IN PATIENTS 4 YEARS OF AGE AND OLDER MAINTENANCE TREATMENT OF ASTHMA AND PREVENTION OF BRONCHOSPASM IN PATIENTS 4 YEARS OF AGE AND OLDER ADJUNCTIVE TREATMENT OF LENNOX-GASTAUT SYNDROME IN PEDIATRIC AND ADULT PATIENTS TREATMENT OF PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA MANAGEMENT OF SECONDARY HYPERPARATHYROIDISM AND RESULTANT METABOLIC BONE DISEASE IN PATIENTS WITH MODERATE TO SEVERE CHRONIC RENAL FAILURE (CCR 15 TO 55ML/MIN) NOT YET ON DIALYSIS USE IN PHOTODYNAMIC THERAPY (PDT) FOR REDUCTION OF OBSTRUCTION AND PALLIATION OF SYMPTOMS IN PATIENTS WITH COMPLETELY OR PARTIALLY OBSTRUCTING ENDOBRONCHIAL NONSMALL CELL LUNG CANCER TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH THE MENOPAUSE AND IN THE TREATMENT OF VULVAR AND VAGINAL ATROPHY IN WOMEN WITH AN INTACT UTERUS USE IN THE SYMPTOMATIC RELIEF OF RHINORRHEA ASSOCIATED WITH THE COMMON COLD IN CHILDREN AGE 5 TO 11 YEARS REDUCE THE INCIDENCE OF BREAST CANCER IN WOMEN AT HIGH RISK FOR BREAST CANCER TREATMENT OF ACUTE SINUSITIS TREATMENT OF UNCOMPLICATED URINARY TRACT INFECTIONS USE IN CONVERSION TO MONOTHERAPY IN ADULTS WITH PARTIAL SEIZURES WHO ARE RECEIVING TREATMENT WITH A SINGLE ENZYME-INDUCING ANTIEPILEPTIC DRUG INPATIENT TREATMENT OF ACUTE DEEP VEIN THROMBOSIS WITH/WITHOUT PULMONARY EMBOLISM WHEN ADMIN WITH WARFARIN SODIM AND OUTPATIENT TREATMENT OF ACUTE DEEP VEIN THROMBOSIS WITHOUT PULMONARY EMBOLISM WHEN ADMIN WITH WARFARIN SODIUM

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

EXCLUSIVITY INDICATION
I-249 I-250

ADB 10 of 51

I-251 I-252 I-253 I-254 I-255 I-256 I-257 I-258 I-259 I-260 I-261 I-262 I-263 I-264 I-265 I-266 I-267 I-268 I-269 I-270 I-271 I-272

I-273

I-274 I-275 I-276 I-277 I-278 I-279 I-280 I-281 I-282 I-283

I-284 I-285 I-286

TREATMENT OF CHRONIC HEPATITIS C IN PATIENTS WITH COMPENSATED LIVER DISEASE PREVIOUSLY UNTREATED WITH ALPHA INTERFERON THERAPY PRIMARY PREVENTION OF CORONARY HEART DISEASE IN PATIENTS WITHOUT SYMPATOMATIC CARDIOVASCULAR DISEASE WHO HAVE AVERAGE TO MODERATELY ELEVATED TOTAL-C AND LDL-C AND BELOW AVERAGE HDL-C TREATMENT OF GENERALIZED ANXIETY DISORDER NEW COMBINATION USE OF PRECOSE FOR PATIENTS WITH TYPE 2 DIABETES TREATED WITH DIET PLUS METFORMIN COMBINATION USE OF PRECOSE FOR PATIENTS WITH TYPE 2 DIABETES TREATED WITH DIET PLUS INSULIN PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS (LOSS OF BONE MASS) PREVENTION OF PNEUMOCYSTIS CARINII PNEUMONIA (PCP) USE IN TREATMENT OF SMALL CELL LUNG CANCER SENSITIVE DISEASE AFTER FAILURE OF FIRST-LINE CHEMOTHERAPY TREATMENT OF CHRONIC HEPATITIS B ASSOCIATED WITH EVIDENCE OF HEPATITIS B VIRAL REPLICATION AND ACTIVE LIVER INFLAMATION FOR PERENNIAL NONALLERGIC RHINITIS FOR AGES 4 AND ABOVE PROPHYLAXIS OF DEEP VEIN THROMBOSIS (DVT), WHICH MAY LEAD TO PULMONARY EMBOLISM, IN PATIENTS UNDERGOING HIP REPLACEMENT SURGERY EXPANDED PEDIATRIC USE IN CHILDREN YOUNGER THAN ONE MONTH OF AGE TO BIRTH (WITH A GESTATIONAL AGE OF 37 WEEKS OR GREATER) TREATMENT OF SOCIAL ANXIETY DISORDER TREATMENT OR PREVENTION OF BRONCHOSPASM WITH REVERSIBLE OBSTRUCTIVE AIRWAY DISEASE AND FOR THE PREVENTION OF EXERCISE INDUCED BRONCHOSPASM IN CHILDREN AGES 4-12 TREATMENT OF UNSTABLE ANGINA AND NON-Q-WAVE MYOCARDIAL INFARCTION FOR THE PREVENTION OF ISCHEMIC COMPLICATIONS IN PATIENTS ON CONCURRENT ASPIRIN THERAPY PREVENTION OF NAUSEA AND VOMITING ASSOCIATED WITH RADIATION, INCLUDING TOTAL BODY IRRADIATION (TBI) AND FRACTIONATED ABDOMINAL RADIATION TREATMENT OF ATOPIC DERMATITIS IN PEDIATRIC PATIENTS 6 YEARS AND OLDER USE OF TOPAMAX AS ADJUNCTIVE THERAPY IN PEDIATRIC PATIENTS AGES 2-16 YEARS WITH PARTIAL ONSET SEIZURES USE IN PEDIATRIC PATIENTS 3 MONTHS OLD AND OLDER - FOR CORTICOSTEROID-RESPONSIVE DERMATOSES PROPHYLAXIS AND CHRONIC TREATMENT OF ASTHMA IN PATIENTS 7-11 YEARS OF AGE PREVENTION OF NAUSEA AND VOMITING ASSOCIATED WITH HIGHLY EMETOGENIC CANCER CHEMOTHERAPY, INCLUDING CISPLATIN ADJUVANT TREATMENT OF NODE-POSITIVE BREAST CANCER ADMINISTRERED SEQUENTIALLY TO STANDARD DOXORUBICIN-CONTAINING COMBINATION CHEMOTHERAPY TREATMENT OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN TREATMENT OF GLUCOCORTICOID-INDUCED OSTEOPOROSIS IN MEN AND WOMEN RECEIVING GLUCOCORTICOIDS IN A DAILY DOSE EQUIVALENT TO 7.5MG OR GREATER OF PREDNISONE AND WHO HAVE LOW BONE MINERAL DENSITY ADJUNCT TO DIET TO INCREASE HDL-C IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA (HETEROZYGOUS FAMILIAL AND NON FAMILIAL) AND MIXED DYSLIPIDEMIA (FREDERICKSON TYPES IIA AND IIB) USE OF TOPAMAX AS ADJUNCTIVE THERAPY IN THE TREATMENT OF PRIMARY GENERALIZED TONICCLONIC SEIZURES USE IN COMBINATION WITH METFORMIN AND SULFONYLUREA IN PATIENTS WITH TYPE 2 DIABETES USE OF REZULIN IN COMBINATION WITH METFORMIN AND SULFONYLUREAS IN PATIENTS WITH TYPE 2 DIABETES TREATMENT OF TYPE III HYPERLIPOPROTEINEMIA TREATMENT OF PATIENTS WITH ISOLATED HYPERTRIGLYCERIDEMIA (FREDERICKSON TYPE IV) TREATMENT OF POST-TRAUMATIC STRESS DISORDER USE OF CARNITOR INJECTION FOR THE PREVENTION AND TREATMENT OF CARNITINE DEFICIENCY IN PATIENTS WITH END STAGE RENAL DISEASE WHO ARE UNDERGOING DIALYSIS INCREASING HDL-C IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA (HETEROZYGOUS FAMILIAL AND NONFAMILIAL) AND MIXED DYSLIPIDEMIA (FREDERICKSON TYPES IIA AND IIB) TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER AFTER FAILURE OF PRIOR PLATINUM-BASED CHEMOTHERAPY TO REDUCE THE INCIDENCE OF MODERATE TO SEVERE XEROSTOMIA IN PATIENTS UNDERGOING POSTOPERATIVE RADIATION TREATMENT FOR HEAD AND NECK CANCER, WHERE THE RADIATION PORT INCLUDES A SUBSTANTIAL PORTION OF THE PAROTID GLANDS TO REDUCE THE NUMBER OF ADENOMATOUS COLORECTAL POLYPS IN FAMILIAL ADENOMATOUS POLYPOSIS PATIENTS AS AN ADJUNCT TO USUAL CARE TREATMENT OF NASAL SYMPTOMS OF SEASONAL AND PERENNIAL RHINITIS IN ADULTS AND CHILDREN 3 YEARS OF AGE AND OLDER TREATMENT OF PATIENTS WITH FREDERICKSON TYPE III

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

EXCLUSIVITY INDICATION
I-287 I-288

ADB 11 of 51

I-289

I-290 I-291 I-292 I-293 I-294 I-295 I-296

I-297 I-298 I-299 I-300 I-301 I-302 I-303 I-304 I-305 I-306 I-307 I-308 I-309 I-310 I-311 I-312 I-313 I-314 I-315

I-316

I-317 I-318 I-319 I-320 I-321 I-322 I-323 I-324

I-325 I-326 I-327

USE OF PRAVASTATIN IN PATIENTS WITH EVIDENT CORONARY HEART DISEASE TO REDUCE THE RISK OF TOTAL MORTALITY BY REDUCING CORONARY DEATH CHANGES IN SEVERAL SECTIONS OF THE INSERT TO INCORPORATE STATEMENTS CONCERNING THE USE OF HIGH DOSES OF LISINOPRIL TO REDUCE THE RISK OF THE COMBINED OUTCOMES OF MORTALITY AND HOSPITALIZATION IN PATIENTS WITH CONGESTIVE HEART FAILURE USE OF AVANDIA IN COMBINATION WITH A SULFONYLUREA IN PATIENTS WITH TYPE 2 DIABETES MELLLITUS WHEN DIET AND EXERCISE WITH EITHER SINGLE AGENT DOES NOT ACHIEVE ADEQUATE GLYCEMIC CONTROL PREVENTION OF CORTICOSTEROID-INDUCED OSTEOPOROSIS PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS TREATMENT OF CORTICOSTEROID-INDUCED OSTEOPOROSIS TREATMENT OF UNCOMPLICATED ACUTE ILLNESS DUE TO INFLUENZA A AND B IN PEDIATRIC PATIENTS 7 YEARS AND OLDER WHO HAVE BEEN SYMPTOMATIC FOR NO MORE THAN 2 DAYS PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS FOR WOMEN WITH AN INTACT UTERUS LONG-TERM INTRAVENOUS TREATMENT OF PULMONARY HYPERTENSION ASSOCIATED WITH THE SCLERODERMA SPECTRUM OF DISEASE IN NYHA CLASS III AND CLASS IV PATIENTS WHO DO NOT RESPOND TO CONVENTIONAL THERAPY SHORT-TERM TREATMENT OF ACUTE MANIC EPISODES ASSOCIATED WITH BIPOLAR I DISORDER TREATMENT OF PATIENTS WITH FREDERICKSON TYPE IIA AND IIB HYPERLIPOPROTEINEMIA USE OF CAMPTOSAR AS A COMPONENT OF FIRST-LINE THERAPY IN COMBINATION WITH 5-FLUROURACIL AND LEUCOVARIN FOR PATIENTS WITH METASTATIC CARCINOMA OF THE COLON OR RECTUM PROPHYLAXIS FOR ASTHMA IN CHILDREN 2-5 YEARS OF AGE TREATMENT OF SIGNS AND SYMPTOMS OF ALLERGIC CONJUNCTIVITIS TREATMENT OF PEDIATRIC PATIENTS WITH PRADER-WILLI SYNDROME INCREASING HDL-CHOLESTEROL IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA AND MIXED DYSLIPIDEMIAS TREATMENT OF PATIENTS WITH FREDERICKSON TYPE IV TREATMENT OF LEVOFLOXACIN SUSCEPTIBLE STRAINS OF PENICILLIN-RESISTANT STREPTOCOCCUS PNEUMONIAE IN PATIENTS WITH COMMUNITY ACQUIRED PNEUMONIA INDUCTION OF SPERMATOGENESIS IN MEN WITH PRIMARY AND SECONDARY HYPOGONADOTROPIC HYPOGONADISM IN WHOM THE CAUSE OF INFERTILITY IS NOT DUE TO PRIMARY TESTICULAR FAILURE NEW COMBINATION USE OF METFORMIN AND INSULIN IN TYPE 2 DIABETES TREATMENT OF PEDIATRIC PATIENTS WITH POLYARTICULAR COURSE JUVENILE RHEUMOTOID ARTHRITIS WHO RESPONDED INADEQUATELY TO SALICYLATES OR OTHER NSAIDS USE OF ACTONEL 35MG ONCE A WEEK TO INCREASE BONE MASS IN MEN WITH OSTEOPOROSIS REDUCTION IN RISK OF MYOCARDIAL INFARCTION, STROKE, AND DEATH FROM CARDIOVASCULAR CAUSES ADJUNCTIVE THERAPY IN THE TREATMENT OF PARTIAL SEIZURES IN PEDIATRIC PATIENTS AGE 3 TO 12 YEARS FIRST LINE TREATMENT OF POSTMENOPAUSAL WOMEN WITH HORMONE RECEPTOR POSITIVE OR HORMONE RECEPTOR UNKNOWN LOCALLY ADVANCED OR METASTATIC BREAST CANCER EXTENSION OF INDICATION TO PROVIDE FOR MAINTENANCE OF RESPONSE TOPICAL ANESTHETIC FOR SUPERFICIAL MINOR SURGERY OF GENITAL MUCOUS MEMBRANES AND AS AN ADJUNCT FOR LOCAL INFILTRATION ANESTHESIA IN GENITAL MUCOUS MEMBRANES THROMBOPROPHYLAXIS OF DEEP VEIN THROMBOSIS, WHICH MAY LEAD TO PULMONARY EMBOLISM,IN MEDICAL PATIENTS WHO ARE AT RISK FOR THROMBOEMBOLIC COMPLICATIONS DUE TO SEVERELY RESTRICTED MOBILITY DURING ACUTE ILLNESS TREATMENT OF NSAID-ASSOCIATED GASTRIC ULCER PATIENTS WHO CONTINUE NSAID USE AND REDUCING RISK OF NSAID-ASSOCIATED GASTRIC ULCERS IN PATIENTS WITH HISTORY OF DOCUMENTED GASTRIC ULCER WHO REQUIRE USE OF AN NSAID PROPHYLAXIS OF INFLUENZA IN ADULTS AND ADOLESCENTS 13 YEARS AND OLDER FIRSTLINE TREATMENT OF POSTMENOPAUSAL WOMEN WITH HORMONE RECEPTOR POSITIVE OR HORMONE RECEPTOR UNKNOWN LOCALLY ADVANCED OR METASTATIC BREAST CANCER USE FOR SUSPECTED OR CONFIRMED METHANOL POISONING, EITHER ALONE OR IN COMBINATION WITH HEMODIALYSIS TREATMENT OF TYPE 2 DIABETES IN PEDIATRIC PATIENTS (AGES 10-16 YEARS) JUVENILE RHEUMATOID ARTHRITIS USE OF DIPRIVAN IN PATIENTS 3 MONTHS TO 16 YEARS COLORECTAL CANCER REDUCING NEUROLOGIC DISABILITY AND/OR FREQUENCY OF CLINICAL RELAPSES IN PATIENTS WITH SECONDARY (CHRONIC) PROGRESSIVE, PROGRESSIVE RELAPSING, OR WORSENING RELAPSING-REMITTING MULTIPLE SCLEROSIS PREVENTION OF RELAPSE AND RECURRENCE OF DEPRESSION GENERALIZED ANXIETY DISORDER SYMPTOMATIC RELIEF OF RHINORRHEA ASSOCIATED WITH SEASONAL ALLERGIC RHINITIS IN PATIENTS 5 YEARS AND OLDER

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

EXCLUSIVITY INDICATION
I-328 I-329 I-330 I-331 I-332 I-333 I-334 I-335 I-336

ADB 12 of 51

I-337 I-338 I-339 I-340 I-341 I-342

I-343 I-344 I-345 I-346 I-347 I-348 I-349 I-350

I-351 I-352 I-353 I-354 I-355 I-356 I-357 I-358 I-359 I-360 I-361

I-362 I-363 I-364 I-365 I-366 I-367

I-368 I-369 I-370

PROPHYLAXIS AND CHRONIC TREATMENT OF ASTHMA IN PATIENTS 5-6 YEARS OF AGE UNCOMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS AND CONTROL OF DAYTIME AND NIGHTTIME HEARTBURN SYSTOMS IN PATIENTS WITH GERD TREATMENT OF MODERATE ACNE VULGARIS EMPIRIC THERAPY IN FEBRILE NEUTROPENIC PATIENTS WITH SUSPECTED FUNGAL INFECTIONS (EFTN) TOPICAL TREATMENT OF TINEA (PITYRIASIS) VERSICOLOR DUE TO MALASSEZIA FURFUR (FORMERLY PITYROSPORUM ORBICULARE) LONG-TERM TREATMENT OF GROWTH FAILURE IN CHILDREN BORN SMALL FOR GESTATIONAL AGE WHO FAIL TO MANIFEST CATCH-UP GROWTH BY TWO YEARS OF AGE ADJUNCTIVE THERAPY IN PATIENTS TWO YEARS AND OLDER WITH SEIZURES ASSOCIATED WITH LENNOXGASTAUT SYNDROME EXPANSION OF INDICATION TO INCLUDE THE TREATMENT OF PATIENTS WITH PREDOMINATELY CLASSIC SUBFOVEAL CHOROIDAL NEOVASCULARIZATION DUE TO PATHOLOGIC MYOPIA OR PRESUMED OCULAR HISTOPLASMOSIS PATHOLOGICAL HYPERSECRETION ASSOCIATED WITH ZOLLINGER-ELLISON SNYDROME MANAGEMENT OF ACUTE PAIN IN ADULTS AND TREATMENT OF PRIMARY DYSMENORRHEA TREATMENT OF HEPATITIS B IN PEDIATRIC PATIENTS AGES 2-17 YEARS ATOPIC DERMATITIS IN PEDIATRIC PATIENTS AGES 2-5 BREAST CANCER COMBINATION THERAPY USE OF FORADIL FOR LONG-TERM, TWICE DAILY (MORNING AND EVENING) ADMINISTRATION IN THE MAINTENANCE TREATMENT OF BRONCHO-CONSTRICTION IN PATIENTS WITH COPD INCLUDING CHRONIC BRONCHITIS AND EMPHYSEMA USE OF COREG FOR SEVERE HEART FAILURE ACNE VULGARIS TREATMENT OF POSTTRAUMATIC STRESS DISORDER TREATMENT OF SYMPTOMATIC GASTRO ESOPHAGEAL REFLUX DISEASE (GERD) TREATMENT OR PREVENTION OF BRONCHOSPASM IN CHILDREN 6 YEARS OF AGE AND OLDER WITH OBSTRUCTIVE AIRWAY DISEASE LONG-TERM, TWICE-DAILY (MORNING AND EVENING) ADMINISTRATION IN THE MAINTENANCE TREATMENT OF BRONCHOSPASM ASSOCIATED WITH COPD (INCLUDING EMPHYSEMA AND CHRONIC BRONCHITIS) ACUTE CORONARY SYNDROME TREATMENT OF HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA IN ADOLESCENT BOYS AND GIRLS AT LEAST ONE YEAR POSTMENARCHAL, AGES 10 TO 17 YEARS, WITH A RECOMMENDED DOSING RANGE OF 10 TO 40MG ONCE DAILY PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS FOR ALL STRENGTHS ANTICOAGULANT IN PATIENTS WITH OR AT RISK FOR HEPARIN-INDUCED THROMBOCYTOPENIA UNDERGOING PERCUTANEOUS CORONARY INTERVENTIONS (PCI) TREATMENT OF SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS MANAGEMENT OF POST HERPETIC NEURALGIA PREMENSTRUAL DYSPHORIC DISORDER TREATMENT OF PATHOLOGICAL HYPERSECRETORY CONDITIONS, INCLUDING ZOLLINGER-ELLISON SYNDROME TREATMENT OF COMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS TREATMENT OF PANIC DISORDER TREATMENT OF VULVAR AND VAGINAL ATROPHY ASSOCIATED WITH THE MENOPAUSE TREATMENT OF NASAL SYMPTOMS OF SEASONAL AND PERENNIAL RHINITIS IN CHILDREN AGES TWO UP TO AGE THREE TREATMENT OF MULTIPLE MYELOMA AND DOCUMENTED BONE METASTASES FROM SOLID TUMORS, IN CONJUNCTION WITH STANDARD ANTINEOPLASTIC THERAPY. PROSTATE CANCER SHOULD HAVE PROGRESSED AFTER TREATMENT WITH AT LEAST ONE HORMONAL THERAPY TREATMENT OF PANIC DISORDER, WITH OR WITHOUT AGORAPHOBIA ADJUVANT TREATMENT OF POST MENOPAUSAL WOMEN WITH HORMONE RECEPTOR POSITIVE EARLY BREAST CANCER TREATMENT OF COMMUNITY-ACQUIRED PNEUMONIA IN ADULTS TREATMENT OF HEART FAILURE (NYHA CLASS II-IV) IN PATIENTS WHO ARE INTOLERANT TO AN ACE INHIBITOR PREVENTION OF RELAPSE FOLLOWING LONG-TERM TREATMENT OF MAJOR DEPRESSIVE DISORDER COMBINATION THERAPY WITH THIAZOLIDINEDIONE TO LOWER BLOOD GLUCOSE IN PTS WHOSE HYPERGLYCEMIA CANNOT BE CONTROLLED BY DIET/EXERCISE PLUS MONOTHERAPY WITH ANY OF THE FOLLOWING AGENTS:METFORMIN,SULFONYLUREAS,REPAGLINIDE,OR THIAZOLIDINEDIONES USE OF GLUCOVANCE WITH A THIAZOLIDINEDIONE WHEN GLYCEMIC CONTROL IS NOT OBTAINED WITH GLUCOVANCE ALONE PREVENTION AND TREATMENT OF POSTOPERATIVE NAUSEA AND VOMITING TREATMENT OF HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA IN CHILDREN, AGES 8-13 YEARS, WITH RECOMMENDED DOSE OF 20MG ONCE DAILY AND IN ADOLESCENTS, AGES 14-18 WITH A RECOMMENDED DOSE OF 40MG ONCE DAILY

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

EXCLUSIVITY INDICATION
I-371 I-372 I-373 I-374 I-375 I-376 I-377

ADB 13 of 51

I-378 I-379

I-380 I-381 I-382 I-383 I-384 I-385 I-386

I-387 I-388 I-389 I-390

I-391 I-392

I-393 I-394 I-395 I-396 I-397 I-398 I-399 I-400 I-401 I-402 I-403

I-404

I-405 I-406

HELICOBACTER PYLORI ERADICATION TO REDUCE THE RISK OF DUODENAL ULCER RECURRENCE NOSOCOMIAL PNEUMONIA TREATMENT OF TYPE 2 DIABETIC NEPHROPATHY SHORT TERM TOPICAL TREATMENT OF MILD TO MODERATE PLAQUE-TYPE PSORIASIS OF NON SCALP REGIONS FIRST LINE THERAPY FOR THE REDUCTION OF INTRAOCULAR PRESSURE IN PATIENTS WITH OPEN-ANGLE GLAUCOMA OR OCULAR HYPERTENSION TREATMENT OF NEWLY DIAGNOSED ADULT PATIENTS WITH PHILADELPHIA CHROMOSOME POSITIVE CHRONIC MYELOID LEUKEMIA (CML) USE OF BRAVELLE FOR MULTIPLE FOLLICULAR DEVELOPMENT (CONTROLLED OVARIAN STIMULATION) DURING ASSISTED REPRODUCTIVE TECHNOLOGY CYCLES IN PATIENTS WHO HAVE PREVIOUSLY RECEIVED PITUITARY SUPPRESSION RELIEF OF SYMPTOMS OF SEASONAL ALLERGIC RHINITIS IN ADULTS AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER USE TAXOTERE IN COMBINATION WITH CISPLATIN FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER WHO HAVE NOT PREVIOUSLY RECEIVED CHEMOTHERAPY FOR THIS CONDITION TO TREAT PATIENTS WITH SCHIZOPHRENIA OR SCHIZOAFFECTIVE DISORDER AT RISK FOR EMERGENT SUICIDAL BEHAVIOR TREATMENT OF COLD SORES (HERPES LABIALIS) IN ADULT AND ADOLESCENT PATIENTS 12 YEARS OF AGE AND OLDER FOR NEWLY-DIAGNOSED HIGH GRADE MALIGNANT GLIOMA PATIENTS AS AN ADJUNCT TO SURGERY AND RADIATION TREATMENT OF TYPE 2 DIABETIC NEPHROPATHY USE IN COMBINATION WITH INSULIN FOR THE TREATMENT OF PATIENTS WITH TYPE 2 DIABETES MELLITUS MODIFICATION OF THE INDICATION FOR COMMUNITY ACQUIRED PNEUMONIA TO ADD"INCLUDING PENICILLIN-RESISTANT STRAINS, MIC PENICILLIN>=2MCG/ML TO STREPTOCOCCUS PNEUMONIAE RAPAMUNE (SIROLIMUS) WITHIN AN IMMUNOSUPPRESSIVE REGIMEN THAT WOULD ALLOW FOR THE WITHDRAWAL OF CYCLOSPORINE 2 TO 4 MONTHS AFTER RENAL TRANSPLANTATION IN PATIENTS CONSIDERED AT LOW TO MODERATE IMMUNOLOGIC RISK FOR RENAL TRANSPLANT REJECTION ADJUNCTIVE THERAPY OF PARTIAL SEIZURES IN PEDIATRIC PATIENTS GREATER THAT OR EQUAL TO 2 YEARS OF AGE TREATMENT OF PATIENTS WITH LEFT VENTRICULAR DYSFUNCTION FOLLOWING MYOCARDIAL INFARCTION SUPRESSION OF RECURRENT GENITAL HERPES IN HIV-INFECTED INDIVIDUALS USE IN PTS AT HIGH RISK CORONARY EVENTS DUE TO EXISTING CORONARY HEART DISEASE,DIABETES,PERIPHERAL VESSEL DISEASE,STROKE HISTORY,OTHER CV DISEASE TO REDUCE RISK TOTAL MORTALITY BY REDUCING CORONARY DEATH,REDUCE NONFATAL MI & STROKE..... ABLATION OF HIGH-GRADE DYSPLASIA IN BARRETT'S ESOPHAGUS PATIENTS WHO DO NOT UNDERGO ESOPHAGECTOMY TX OF PED PATIENTS W/PH+ CHRONIC PHASE CML DISEASE RECUR AFTER STEM CELL TRNSPLT OR RESIST TO INTERFERON ALPHA THERAPY.NO CONTROLLED TRIALS DEMONSTRATING A CLINICAL BENEFIT SUCH AS IMPROVE IN DISEASE RELATED SX OR INCREASED SURVIVAL CHRONIC BACTERIAL PROSTATITIS USE IN PATIENTS WITH CORONARY HEART DISEASE TO REDUCE THE RISK OF UNDERGOING CORONARY REVASCULARIZATION PROCEDURES TO IMPROVE PHYSICAL FUNCTION EXPANDED INDICATION TO INCLUDE THE ASSESSMENT OF VENTRICULAR FUNCTION IN SUBJECTS BEING EVALUATED FOR HEART DISEASE AND/OR VENTRICULAR FUNCTION EXTENDED PROPHYLAXIS IN PATIENTS UNDERGOING HIP FRACTURE SURGERY IDIOPATHIC SHORT STATURE TREATMENT OF CANDIDEMIA AND THE FOLLOWING CANDIDA INFECTIONS: INTRA-ABDOMINAL ABSCESSES, PERITONITIS AND PLEURAL SPACE INFECTIONS USE OF OLANZAPINE IN COMBINATION WITH LITHIUM OR VALPROATE FOR THE TREATMENT OF ACUTE MANIC EPISODES ASSOCIATED WITH BIPOLAR DISORDER LONGER-TERM EFFICACY OF ARIPIPRAZOLE IN THE TREATMENT OF SCHIZOPHRENIA DIABETIC FOOT INFECTIONS WITHOUT CONCOMITANT OSTEOMYELITIS USE OF VALTREX IN COMBINATION WITH SAFER SEX PRACTICES FOR THE REDUCTION OF THE RISK OF TRANSMISSION OF GENITAL HERPES DURING SUPPRESIVE THERAPY OF THE SOURCE PARTNER IN A HETEROSEXUAL COUPLE MAINTENANCE TREATMENT OF BIPOLAR I DISORDER TO DELAY THE TIME TO OCCURRENCE OF MOOD EPISODES (DEPRESSION, MANIA, HYPOMANIA, MIXED EPISODES) IN PATIENTS TREATED FOR ACUTE MOOD EPISODES WITH STANDARD THERAPY TREATMENT OF PREMENSTRUAL DYSPHORIC DISORDER (PMDD) USING AN INTERMITTENT DOSING REGIMEN PREVENTION OF CYTOMEGALOVIRUS DISEASE IN KIDNEY, HEART, AND KIDNEY-PANCREAS TRANSPLANT PATIENTS AT HIGH RISK (DONOR CMV SEROPOSITIVE/RECIPIENT CMV SERONEGATIVE)

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

EXCLUSIVITY INDICATION
I-407

ADB 14 of 51

I-408 I-409 I-410 I-411 I-412 I-413 I-414

I-415 I-416 I-417 I-418 I-419 I-420 I-421 I-422 I-423 I-424 I-425 I-426 I-427 I-428

I-429 I-430 I-431 I-432 I-433

I-434

I-435 I-436 I-437 I-438 I-439 I-440 I-441

IMPROVE SURVIVAL OF STABLE PATIENTS WITH LEFT VENTRICULAR SYSTOLIC DYSFUNCTION (EJECTION FRACTION<=40%) AND CLINICAL EVIDENCE OF CONGESTIVE HEART FAILURE AFTER AN ACUTE MYOCARDIAL INFARCTION STIMULATION OF PANCREATIC SECRETIONS TO FACILITATE THE INDENTIFICATION OF THE AMPULLA OF VATER AND ACCESSORY PAPILLA DURING ENDOSCOPIC RETROGRADE CHOLANGIO-PANCREATOGRAPHY (ERCP) ESOPHAGEAL CANDIDIASIS USE OF ADVAIR DISKUS 250/50 FOR CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) ASSOCIATED WITH CHRONIC BRONCHITIS EXPANDED INDICATION FOR USE IN COMBINATION WITH ANTIDIABETIC DRUGS IN THE THIAZOLIDINEDIONE CLASS MONOTHERAPY FOR THE SHORT TERM TREATMENT OF ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER ADJUNCTIVE THERAPY FOR THE SHORT TERM TREATMENT OF ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER PROPHYLAXIS OF DEEP VEIN THROMBOSIS (DVT), WHICH MAY LEAD TO PULMONARY EMBOLISM (PE) IN MEDICAL PATIENTS WHO ARE AT RISK FOR THROMBOEMBOLIC COMPLICATIONS DUE TO SEVERELY RESTRICTED MOBILITY DURING ACUTE ILLNESS SEVERE HYPERTENSION WHEN THE VALUE OF ACHIEVING PROMPT BLOOD PRESSURE CONTROL EXCEEDS THE RISK OF INITIATING COMBINATION THERAPY THE USE OF CIPRO XR FOR COMPLICATED URINARY TRACT INFECTIONS AND ACUTE UNCOMPLICATED PYELONEPHRITIS USE IN THE LONG TERM TREATMENT OF BIPOLAR I DISORDER ADJUNCTIVE THERAPY W/ MOOD STABILIZERS (LITHIUM OR DIVALPROEX) IN THE TREATMENT OF ACUTE MANIC EPISODES ASSOCIATED WITH BIPOLAR I DISORDERS MONOTHERAPY IN THE TREATMENT OF ACUTE MANIC EPISODES ASSOCIATED WITH BIPOLAR I DISORDER TOPICAL TREATMENT OF CLINICALLY TYPICAL, NONHYPERKERATOTIC, NONHYPERTROPHIC ACTINIC KERATOSES ON THE FACE OR SCALP IN IMMUNOCOMPETENT ADULTS TREATMENT OF COMPLICATED URINARY TRACT INFECTIONS AND PYELONEPHRITIS DUE TO E.COLI FOR PED PATIENTS (1-17) NOT AS FIRST CHOICE INDICATED FOR THE IN-HOSPITAL SHORT-TERM (UP TO 4 HOURS) REDUCTION IN BLOOD PRESSURE IN PEDIATRIC PATIENTS ACUTE TREATMENT OF MIGRAINE ATTACKS WITH OR WITHOUT AURA IN ADULTS MANAGEMENT OF SECONDARY HYPERPARATHYROIDISM IN PATIENTS WITH MODERATE TO SEVERE CHRONIC RENAL INSUFFICIENCY NOT YET ON DIALYSIS FLOXATIN IN COMBINATION WITH INFUSIONAL 5-FLUOROURACIL (5-FU) AND LEUCOVORIN (LV) FOR THE TREATMENT OF PATIENTS PREVIOUSLY UNTREATED FOR ADVANCED COLORECTAL CANCER TREATMENT OF ACUTE PULMONARY EMBOLISM WHEN ADMINISTERED IN CONJUNCTION WITH WARFARIN SODIUM TREATMENT OF ACUTE DEEP VEIN THROMBOSIS WITHOUT PULMONARY EMBOLISM WHEN ADMINISTERED IN CONJUNCTION WITH WARFARIN SODIUM FOR USE IN COMBINATION WITH PACLITAXEL FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH METASTATIC BREAST CANCER AFTER FAILURE OF PRIOR ANTHRACYCLINE CONTAINING ADJUVANT CHEMOTHERAPY UNLESS ANTHRACYCLINES WERE CLINICALLY CONTRAINDICATED FOR USE IN COMBINATION WITH PREDNISONE FOR THE TREATMENT OF PATIENTS WITH ANDROGEN INDEPENDENT (HORMONE REFRACTORY) METASTATIC PROSTATE CANCER FOR USE IN THE RELIEF OF THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS IN ADULTS NOSOCOMIAL PNEUMONIA AND COMMUNITY-ACQUIRED PNEUMONIA CAUSED BY STREPTOCOCCUS PNEUMONIAE INDICATION EXPANDED TO INCLUDE MULTI-DRUG RESISTANT STRAINS TREATMENT OF COMMUNITY ACQUIRED PNEUMONIA CAUSED BY MULTI-DRUG RESISTANT STREPTOCOCCUS PNEUMONIAE TREATMENT OF BIOPSY-CONFIRMED, PRIMARY SUPERFICIAL BASAL CELL CARCINOMA IN IMMUNOCOMPETENT ADULTS, WITH A MAXIMUM TUMOR DIAMETER OF 2.0CM, LOCATED ON THE TRUNK (EXCLUDING ANOGENITAL SKIN), NECK, OR EXTREMITIES (EXCLUDING HANDS AND FEET) PREVENTION OF CARDIOVASCULAR DISEASE IN ADULT PATIENTS WITHOUT CLINICALLY EVIDENT HEART DISEASE, BUT WITH MULTIPLE RISK FACTORS FOR CORONARY HEART DISEASE TO REDUCE RISK OF MI AND RISK FOR REVASCULARIZATION PROCEDURES AND ANGINA CHRONIC IDIOPATHIC CONSTIPATION FOR USE IN COMBINATION WITH DOXORUBICIN AND CYCLOPHOSPHAMIDE FOR THE ADJUVANT TREATMENT OF PATIENTS WITH OPERABLE NODE-POSITIVE BREAST CANCER TREATMENT OF ACUTE MANIC AND MIXED EPISODES ASSOCIATED WITH BIPOLAR DISORDER EMPIRICAL THERAPY FOR PRESUMED FUNGAL INFECTIONS IN FEBRILE, NEUTROPENIC PATIENTS USED TO TREAT ADULTS WITH GROWTH HORMONE DEFICIENCY FOR THE REPLACEMENT OF ENDOGENOUS GROWTH HORMONE IN ADULTS WITH GROWTH HORMONE DEFICIENCY USE COMBINATION WITH INFUSIONAL 5-FU/LV FOR ADJUVANT TREATMENT STAGE III COLON CANCER PTS WHO HAVE UNDERGONE COMPLETE RESECTION PRIMARY TUMOR-BASED ON IMPROVEMENT IN DISEASE FREE SURVIVAL, NO DEMONSTRATED BENEFIT OVERALL SURVIVAL AFTER 4YRS

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

EXCLUSIVITY INDICATION
I-442 I-443 I-444 I-445

ADB 15 of 51

I-446

I-447 I-448 I-449 I-450 I-451 I-452 I-453 I-454 I-455

I-456

I-457 I-458

I-459 I-460 I-461

I-462 I-463 I-464 I-465 I-466 I-467 I-468 I-469 I-470 I-471

I-472 I-473 I-474 I-475 I-476

USED FOR CANDIDEMIA IN NONNEUTROPENIC PATIENTS AND THE FOLLOWING CANDIDA INFECTIONS: DISSEMINATED INFECTIONS IN SKIN & INFECTIONS IN ABDOMEN, KIDNEY, BLADDER WALL, AND WOUNDS TREATMENT OF NASAL POLYPS IN PATIENTS 18 YEARS OF AGE AND OLDER USE OF PROTONIX IV FOR INJECTION AS STAND ALONE THERAPY FOR THE SHORT-TERM TREATMENT OF PATIENTS HAVING GASTROESOPHAGEAL REFLUX (GERD) WITH A HISTORY OF EROSIVE ESOPHAGITIS TO IMPROVE (COMPARED TO 4.25% DEXTROSE) LONG-DWELL ULTRAFILTRATION AND CLEARANCE OF CREATININE AND UREA NITROGEN IN PATIENTS WITH HIGH AVERAGE OR GREATER TRANSPORT CHARACTERISTICS, AS DEFINED USING THE PERITONEAL EQUILIBRATION TEST (PET) EXTENDED ADJUVANT TREATMENT OF EARLY BREAST CANCER IN POSTMENOPAUSAL WOMEN WHO HAVE RECEIVED 5 YRS ADJUVANT TAMOXIFEN THERAPY-EFFECTIVENESS BASED ON AN ANALYSIS OF DISEASE FREE SURVIVAL IN PATIENTS TREATED FOR A MEDIAN 24 MONTHS USE OF COPEGUS (RIBAVIRIN) FOR TREATMENT OF CHRONIC HEPATITIS C IN ADULT PATIENTS COINFECTED WITH HIV IN COMBINATION WITH PEGASYS (PEGINTERFERON ALFA-2A) TREATMENT OF HEART FAILURE (NYHA CLASS II-IV AND EJECTION FRACTION <=40%) TO REDUCE THE RISK OF DEATH FROM CARDIOVASCULAR CAUSES AND TO REDUCE HOSPITALIZATIONS FOR HEART FAILURE TO IMPROVE WAKEFULNESS IN TWO NEW PATIENT POPULATIONS WITH EXCESSIVE SLEEPINESS: THOSE WITH OBSTRUCTIVE SLEEP APNEA/HYPOPNEA SYNDROME AND THOSE WITH SHIFT WORK SLEEP DISORDER TREATMENT OF PATIENTS WITH NEWLY DIAGNOSED HIGH GRADE GLIOMAS CONCOMITANTLY WITH RADIOTHERAPY AND THEN AS ADJUVANT TREATMENT MANAGEMENT OF ENDOMETRIOSIS ASSOCIATED PAIN EXPANDED INDICATION TO INCLUDE TREATMENT OF MULTIPLE MYELOMA PATIENTS WHO HAVE RECEIVED AT LEAST 1 PRIOR THERAPY USE IN COMBINATION WITH A SULFONYLUREA PLUS METFORMIN WHEN DIET, EXERCISE AND BOTH AGENTS DO NOT RESULT IN ADEQUATE GLYCEMIC CONTROL (TRIPLE THERAPY) MAINTENANCE OF CLINICAL REMISSION OF MILD TO MODERATE CHRON'S DISEASE INVOLVING THE ILEUM AND/OR THE ASCENDING COLON FOR UP TO 3 MONTHS MODIFIED HEART FAILURE INDICATION TO INCLUDE TREATMENT OF HEART FAILURE IN PATIENTS WITH LEFT VENTRICULAR SYSTOLIC DYSFUNCTION (NYHA CLASS II-IV; EJECTION FRACTION LESS THAN OR EQUAL TO 40% TO REDUCE CARDIOVASCULAR DEATH AND TO REDUCE HEART FAILURE HOSPITALIZATIONS. INCLUDES ADDITIONAL INFORMATION ON THE ADDED EFFECT ON THESE OUTCOMES WHEN USED WITH AN ACE INHIBITOR TREATMENT OF PATIENTS UNDERGOING ABDOMINAL SUREGERY WHO ARE AT RISK FOR THROMBOEMBOLIC COMPLIATIONS USE OF BIVALIRUDIN FOR INJECTION WITH PROVISIONAL USE OF GLYCOPROTEIN IIB/IIA INHIBITOR (GPI) AS LISTED IN THE CLINICAL TRIALS REPLACE-2 SECTION FOR USE AS AN ANTICOAGULANT IN PATIENTS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION (PCI) NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE (NDD-CKD) PATIENTS RECEIVING OR NOT RECEIVING AN ERYTHROPOIETIN TREATMENT OF DIARRHEA CAUSED BY CRYPTOSPORIDIUM PARVUM IN NON-HIV INFECTED PATIENTS 12 YEARS OF AGE AND OLDER USE AS A SINGLE AGENT FOR ADJUVANT TREATMENT IN PATIENTS WITH DUKES' C COLON CANCER WHO HAVE UNDERGONE COMPLETE RESECTION OF THE PRIMARY TUMOR WHEN TREATMENT WITH FLUOROPYRIMIDINE THERAPY ALONE IS PREFERRED LONG TERM TREATMENT OF IDIOPATHIC SHORT STATURE TREATMENT OF PATIENTS POST MYOCARDIAL INFARCTION TREATMENT OF MODERATE TO SEVERE PRIMARY RESTLESS LEGS SYNDROME PERENNIAL ALLERGIC RHINITIS IN ADULTS AND PEDIATRIC PATIENTS 6 MONTHS OF AGE AND OLDER FOR RELIEF OF THE SIGNS AND SYMPTOMS OF ANKYLOSING SPONDYLITIS USE OF TOPIRAMATE AS INITIAL MONOTHERAPY IN PATIENTS 10 YEARS OF AGE AND OLDER WITH PARTIAL ONSET OR PRIMARY GENERALIZED TONIC CLONIC SEIZURES USE IN PATIENTS WITH STABLE CORONARY ARTERY DISEASE TO REDUSE THE RISK OF CARDIOVASCULAR MORTALITY OR NON-FATAL MYOCARDIAL INFECTION RELIEF OF THE SIGNS AND SYMPTOMS OF PAUCIARTICULAR OR POLYARTICULAR COURSE JUVENILE RHEUMATOID ARTHRITIS IN PATIENTS 2 YEARS OF AGE AND OLDER DIABETIC PERIPHERAL NEUROPATHIC PAIN INDICATED TO REDUCE THE RISK OF MYOCARDIAL INFARCTION AND STROKE IN PATIENTS WITH TYPE 2 DIABETES AND WITHOUT CLINICALLY EVIDENT CORONARY HEART DISEASE BUT WITH MULTIPLE RISK FACTORS FOR CORONARY HEART DISEASE USE IN PATIENTS WITH ANGIOGRAPHICALLY DOCUMENTED CORONARY ARTERY DISEASE USE IN COMBINATION WITH GEMCITABINE FOR THE FIRST LINE TREATMENT OF PATIENTS WITH LOCALLY ADVANCED UNRESECTABLE OR METASTATIC PANCREATIC CANCER TREATMENT OF IRON DEFICIENCY ANEMIA IN PERITONEAL DIALYSIS DEPENDANT CHRONIC KIDNEY DISEASE IN PATIENTS RECIEVING AN ERYTHROPOIETIN PREVENTION OF NAUSEA AND VOMITTING ASSOCIATED WITH INITIAL AND REPEAT COURSES OF MODERATELY EMETOGENIC CANCER CHEMOTHERAPY TREATMENT OF DIABETIC FOOT INFECTIONS WITHOUT OSTEOMYELITIS

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

EXCLUSIVITY INDICATION
I-477

ADB 16 of 51

I-478 I-479

I-480 I-481 I-482 I-483 I-484 I-485 I-486 I-487 I-488 I-489 I-490

I-491 I-492 I-493

I-494

I-495

I-496 I-497 I-498 I-499

I-500 I-501 I-502

I-503 I-504 I-505

I-506 I-507

I-508 I-509 I-510 I-511 I-512

TREATMENT OF COMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS CAUSED BY METHICILLIN SUSCEPTIBLE STAPHYLOCOCCUS AUREUS, ESCHERICHIA COLI, KLEBSIELLA PNEUMONIAE, OR ENTEROBACTER CLOACAE FOR USE AS ADJUNCTIVE THERAPY IN THE TREATMENT OF PARTIAL SEIZURES IN CHILDREN WITH EPILEPSY AGED 2-4 YEARS TREATMENT OF COMPLICATED INTRA-ABDOMINAL INFECTIONS CAUSED BY E.COLI, B. FRAGILIS, S.ANGINOSUS, S.CONSTELLATUS, E. FAECALIS, P. MIRABILIS, C. PERFRINGENS, B. THETAIOTAOMICRON OR PEPTOSTREPTOCOCCUS SPECIES PROPHYLAXIS OF INFLUENZA FOR PATIENTS BETWEEN 1-12 YEARS OF AGE INDICATED FOR THE ADJUVANT TREATMENT OF POSTMENOPAUSAL WOMEN WITH HORMONE RECEPTOR POSITIVE EARLY BREAST CANCER TREATMENT OF ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER WITH OR WITHOUT PSYCHOTIC FEATURES PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS FOR THE RISK REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCERS TREATMENT OF POSTOPERATIVE INFLAMMATION AND REDUCTION OF OCULAR PAIN IN PATIENTS WHO HAVE UNDERGONE CATARACT EXTRACTION ANGIOMAX IS INDICATED FOR PATIENTS WITH, OR AT RISK OF, HIT/HITTS UNDERGOING PCI INDICATED FOR THE RELIEF OF THE INFAMMATORY AND PRURITIC MANIFESTATIONS OF CORTICOSTEROID RESPONSIVE DERMATOSES IN PATIENTS 12 YRS OF AGE OR OLDER MAINTENANCE THERAPY IN BIPOLAR I DISORDER FOR USE IN PEDIATRIC PATIENTS WITH TYPE I DIABETES FOR USE IN COMBINATION WITH CISPLATIN AND FLUOROURACIL FOR THE TREATMENT OF PATIENTS WITH ADVANCED GASTRIC ADENOCARCINOMA, INCLUDING ADENOCARCINOMA OF GASTROESOPHAGEAL JUNCTION, WHO HAVE NOT RECEIVED PRIOR CHEMOTHERAPY FOR ADVANCED DISEASE INFLUENZA PROPHYLAXIS MONOTHERAPY IN THE TREATMENT OF ACUTE MANIC OR MIXED EPISODES IN BIPOLAR I DISORDER, WITH OR WITHOUT PSYCHOTIC FEATURES ADMINISTERED IN COMBINATION WITH FENOFIBRATE, AS ADJUNCTIVE THERAPY TO DIET FOR THE REDUCTION OF ELEVATED TOTAL-C, LDL-C, APO B, AND NON-HDL-C IN PATIENTS WITH MIXED HYPERLIPIDEMIA CLINICAL DATA IN SUPPORT OF AVANDAMET AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2 DIABETES MELLITUS WHEN TREATMENT WITH DUAL ROSIGLITAZONE AND METFORMIN THERAPY IS APPROPRIATE ADJUVANT TX OF POSTMENOPAUSAL WOMEN WITH ESTROGEN-RECEPTOR POSITIVE EARLY BREAST CANCER WHO HAVE RECEIVED 2 TO 3 YRS OF TAMOXIFEN AND ARE SWITCHED TO AROMASIN FOR COMPLETION OF A TOTAL OF 5 CONSECUTIVE YRS OF ADJUVANT HORMONAL THERAPY LONG TERM TREATMENT OF GROWTH FAILURE ASSOCIATED WITH TURNER SYNDROME IN PATIENTS WHO HAVE OPEN EPIPHYSES PREVENTION OF SEASONAL MAJOR DEPRESSIVE EPISODES IN PATIENTS WITH SEASONAL AFFECTIVE DISORDER PREVENTION OF POSTOPERATIVE NAUSEA AND VOMITING USE OF GEMZAR IN COMBINATION WITH CARBOPLATIN FOR THE TREATMENT OF PATIENTS WITH ADVANCED OVARIAN CANCER THAT HAS RELAPSED AT LEAST 6 MONTHS AFTER COMPLETION OF PLATINUMBASED THERAPY FOR USE IN COMBINATION WITH DEXAMETHASONE FOR THE TREATMENT OF MULTIPLE MYELOMA PATIENTS WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY TREATMENT OF RECURRENT HERPES LABIALIS (COLD SORES) IN IMMUNOCOMPETANT PATIENTS WITH A SINGLE DOSE OF FAMCICLOVIR 1500 MG. FOR PTS WITH ST-SEGMENT ELEVATION ACUTE MYOCARDIAL INFARCTION, PLAVIX TO REDUCE RATE OF DEATH FROM ANY CAUSE AND THE RATE OF A COMBINED ENDPOINT OF DEATH, REINFARCTION OR STROKE. NOT KNOWN TO PERTAIN TO PTS WHO RECEIVE PRIMARY ANGIOPLASTY TREATMENT OF MAJOR DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR DISORDER TREATMENT OF PATHOLOGICAL HYPERSECRETORY CONDITIONS INCLUDING ZOLLINGER-ELLISON SYNDROME TREATMENT OF STAPHYLOCOCCUS AUREUS BLOODSTREAM INFECTIONS (BACTEREMIA), INCLUDING THOSE WITH RIGHT SIDED INFECTIVE ENDOCARDITIS, CAUSED BY METHICILLIN-SUSCEPTIBLE AND METHICILLIN-RESISTANT ISOLATES ADJUNCTIVE THERAPY OF MYOCLONIC SEIZURES IN ADULTS AND ADOLESCENTS AGE 12 AND OVER WITH JUVENILE MYOCLONIC EPILEPSY ADJUNCT TO DIET TO REDUCE TOTAL-C, LDL-C AND APO B LEVELS IN ADOLESCENT BOYS AND GIRLS WHO ARE AT LEAST ONE YEAR POST-MENARCHE, 10-16 YEARS OF AGE, WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA PREMENSTRUAL DYSPHONIC DISORDER TREATMENT OF IRRATABILITY ASSOCIATED WITH AUTISTIC DISORDER ADULT DERMAFIBROSARCOMA PROTUBERANS (DFSP) ADULT MYELODYSPLASTIC SYNDROME/MYELOPROLIFERATIVE DISEASES (MDS/MDP) ADULT PH+ ACUTE LYMPHOBLASTIC LEUKEMIA (ALL) MONOTHERAPY

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

EXCLUSIVITY INDICATION
I-513 I-514 I-515 I-516 I-517 I-518 I-519

ADB 17 of 51

I-520

I-521 I-522

I-523

I-524 I-525 I-526 I-527 I-528 I-529 I-530 I-531 I-532 I-533 I-534 I-535 I-536 I-537 I-538 I-539 I-540 I-541 I-542 I-543 I-544 I-545 I-546 I-547 I-548 I-549 I-550 I-551 I-552

I-553 I-554

ADULT AGGRESSIVE SYSTEMIC MASTOCYTOSIS (ASM) ADULT HYPEREOSINOPHILIC SYNDROME/CHRONIC EOSINOPHILIC LEUKEMIA (HES/CEL) PROPHYLAXIS OF SURGICAL SITE INFECTION FOLLOWING ELECTIVE COLORECTAL SURGERY PRIMARY GENERALIZED TONIC CLONIC SEIZURES IN ADULTS AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER TREATMENT OF MODERATE TO SEVERE PRIMARY RESTLESS LEG SYNDROME (RLS) TREATMENT OF SHORT STATURE OR GROWTH FAILURE IN CHILDREN WITH SHOX (SHORT STATURE HOMEOBOX CONTAINING GENE) DEFICIENCY WHOSE EPIPHYSES ARE NOT CLOSED USE OF TAXOTERE (DOCETAXEL) INJECTION CONCENTRATE IN COMBINATION WITH CISPLATIN AND FLUOROURACIL FOR THE INDUCTION OF PATIENTS WITH INOPERABLE LOCALLY ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK (SCCHN) USE OF EXENATIDE IN PATIENTS WITH TYPE 2 DIABETES MELLITUS WHO ARE USING A THIAZOLIDINEDIONE ALONE OR IN COMBINATION WITH METFORMIN BUT HAVE NOT ACHIEVED ADEQUATE GLYCEMIC CONTROL TREATMENT OF PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST 1 YEAR PRIOR THERAPY TREATMENT OF MODERATE ACNE VULGARIS IN WOMEN AT LEAST 14 YRS OF AGE, WHO HAVE NO KNOWN CONTRAINDICATIONS TO ORAL CONTRACEPTIVE THERAPY, AND HAVE ACHIEVED MENARCHE, IF THE PATIENT DESIRES AN ORAL CONTRACEPTIVE FOR BIRTH CONTROL. USE IN ADULT PATIENTS WITH CLINICALLY EVIDENT CORONARY HEART DISEASE TO REDUCE THE RISK OF NONFATAL MYOCARDIAL INFARCTION, FATAL AND NONFATAL STROKE, ANGINA, REVASCULARIZATION PROCEDURES AND HOSPITALIZATION FOR CONGESTIVE HEART FAILURE GENERALIZED ANXIETY DISORDER (GAD) USE OF 0.5MG/0.1MG FOR PREVENTION OF POST-MENOPAUSAL OSTEOPOROSIS TREATMENT OF HYPONATREMIA IN HOSPITALIZED PATIENTS ADJUNCTIVE THERAPY IN THE TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC SEIZURES IN ADULTS AND CHILDREN 6 YEARS OF AGE AND OLDER WITH IDIOPATHIC GENERALIZED EPILEPSY TREATMENT OF MODERATE TO SEVERE VAGINAL DRYNESS AND PAIN WITH INTERCOURSE, SYMPTOMS OF VULVAR AND VAGINAL ATROPHY ASSOCIATED WITH MENOPAUSE TREATMENT OF DEMENTIA OF THE ALZHEIMER'S TYPE IN PATIENTS WITH SEVERE ALZHEIMER'S DISEASE PREVENTION OF EXERCISE-INDUCED BRONCHOCONSTRICTION IN PATIENTS 15 YEARS OF AGE AND OLDER MAINTENANCE TREATMENT OF SCHIZOPHRENIA TREATMENT OF BACTERIAL VAGINOSIS IN NON-PREGNANT FEMALES ACUTE ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI) EXTENDED TREATMENT OF SYMPTOMATIC VENOUS THROMBOEMBOLISM (VTE) AND/OR PULMONARY EMBOLISM TO REDUCE THE RECCURENCE OF VTE IN PATIENTS WITH CANCER MANAGEMENT OF FIBROMYALGIA FOR THE TREATMENT OF SHORT STATURE IN CHILDREN WITH NOONAN SYNDROME LONG TERM TREATMENT OF PANIC DISORDER SHORT TERM TREATMENT OF PANIC DISORDER REDUCTION IN RISK OF INVASIVE BREAST CANCER IN POSTMENOPAUSAL WOMEN WITH OSTEOPOROSIS OR AT HIGH RISK FOR INVASIVE BREAST CANCER TREATMENT OF SCHIZOPHRENIA IN ADOLESCENTS AGES 13-17 TREATMENT OF BIPOLAR I DISORDER IN CHILDREN AGES 10-12 AND ADOLESCENTS AGES 13-17 EXPANSION OF PATIENT POPULATION FOR HEAD AND NECK CANCER FROM "INOPERABLE" PATIENTS TO ALL PATIENTS USE IN COMBINATION WITH CISPLATIN AND FLUOROURACIL FOR THE INDUCTION TREATMENT OF PATIENTS WITH LOCALLY ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK (SCCHN) ADJUNCTIVE THERAPY OF MYOCLONIC SEIZURES IN ADULTS AND ADOLESCENTS AGE 16 AND OVER WITH JUVENILE MYOCLONIC EPILEPSY ADJUNCTIVE TREATMENT TO TREAT PATIENTS WITH MAJOR DEPRESSIVE DISORDER TREATMENT OF UNRESECTABLE HEPATOCELLULAR CARCINOMA ADJUNCTIVE THERAPY TO DIET TO SLOW THE PROGRESSION OF ARTHEROSCLEROSIS IN ADULT PATIENTS AS PART OF A TREATMENT STRATEGY TO LOWER TOTAL-C AND LDL-C TO TARGET LEVELS SEASONAL ALLERGIC RHINITIS IN PATIENTS 6 THROUGH LESS THAN 12 YEARS OF AGE USE OF AVALIDE TABLETS AS INITIAL THERAPY IN PATIENTS WHO ARE LIKELY TO NEED MULTIPLE DRUGS TO ACHIEVE THEIR BLOOD PRESSURE GOALS TREATMENT OF HYPERTENSION IN PEDIATRIC PATIENTS 6-16 YEARS OF AGE TREATMENT OF SHORT STATURE IN CHILDREN WITH TURNER'S SYNDROME ADJUNCTIVE TREATMENT FOR RADIOIODINE ABLATION OF THYROID TISSUE REMNANTS IN PATIENTS WHO HAVE UNDERGONE THYROIDECTOMY FOR WELL-DIFFERENTIATED THYROID CANCER AND WHO DO NOT HAVE EVIDENCE OF METASTATIC THYROID CANCER FOR USE AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS TREATMENT OF PATIENTS WITH CANDIDEMIA, ACUTE DISSEMINATED CANDIDIASIS, CANDIDA PERITONIS AND ABSCESSES

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

EXCLUSIVITY INDICATION
I-555 I-556 I-557 I-558 I-559 I-560 I-561 I-562 I-563 I-564 I-565 I-566 I-567 I-568

ADB 18 of 51

I-569 I-570 I-571 I-572 I-573 I-574 I-575 I-576 I-577 I-578 I-579 I-580 I-581 I-582 I-583 I-584 I-585 I-586 I-587 I-588 I-589 I-590 I-591 I-592 I-593 I-594 I-595 I-596 I-597

TREATMENT OF ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER IN PEDIATRIC PATIENTS AGED 10-17 YEARS PREVENTION OF POST OPERATIVE NAUSEA AND VOMITING FOR UP TO 24 HOURS FOLLOWING SURGERY USE OF AMITIZA (LUBIPROSTONE) 8 MCG TWICE DAILY FOR TREATMENT OF IRRITABLE BOWEL SYNDROME WITH CONSTIPATION IN WOMEN GREATER THAN OR EQUAL TO 18 YEARS OLD MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION AND REDUCING EXACERATIONS IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) INCLUDING CHRONIC BRONCHITIS AND EMPHYSEMA ADJUNCTIVE THERAPY ADDED TO LITHIUM OR VALPROATE IN SHORT TERM TREATMENT OF BIPOLAR DISORDER, MANIC OR MIXED MAINTENANCE TREATMENT FOR BIPOLAR I DISORDER, AS ADJUNCTIVE THERAPY TO LITHIUM OR DIVALPROEX LONG-TERM TREATMENT OF SOCIAL ANXIETY DISORDER MAINTENANCE TREATMENT OF ATTENTION-DEFICIT DISORDER (ADHD) IN CHILDREN AND ADOLESCENTS ADJUNCTIVE THERAPY IN THE TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC SIEZURES IN ADULTS AND CHILDREN 16 YEARS OF AGE AND OLDER WITH IDIOPATHIC GENERALIZED EPILEPSY TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA USE OF DUTASTERIDE IN COMBINATION WITH TAMSULOSIN FOR THE TREATMENT OF SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH) MANAGEMENT OF FIBROMYALGIA INITIAL THERAPY IN PATIENTS LIKELY TO NEED MULTIPLE DRUGS TO ACHIEVE THEIR BLOOD PRESSURE GOALS USE OF APTIVUS, CO-ADMINISTERED W/RITONAVIR, FOR COMBINATION ANTIRETROVIRAL TREATMENT OF HIV-1 INFECTED PED (AGE 2-18 YRS) PATIENTS WHO ARE TREATMENT-EXPERIENCED AND INFECTED W/HIV-1 STRAINS RESISTANT TO MORE THAN ONE PROTEASE INHIBITOR TREATMENT OF CHRONIC HEPATITIS B TREATMENT OF CHICKEN POX IN IMMUNOCOMPETENT PEDIATRIC PATIENTS 2 TO <18 YEARS OF AGE NON-SMALL CELL LUNG CANCER IN COMBINATION WITH CISPLATIN AND AS SINGLE AGENT FOR NONSQAUMOUS NON-SMALL CELL LUNG CANCER TREATMENT OF GROWTH FAILURE IN CHILDREN BORN SMALL FOR GESTATIONAL AGE (SGA) WITH NO CATCH-UP BY AGE 2-4 YRS. TO TREAT PATIENTS WITH PRIMARY DYSBETALIPOPROTEINEMIA (FREDICKSON TYPE III HYPERLIPOPROTEINEMIA) AS AN ADJUNCT TO DIET MONOTHERAPY IN THE TREATMENT OF BIPOLAR DEPRESSION MONOTHERAPY IN THE TREATMENT OF BIPOLAR MANIA ADJUNCTIVE THERAPY IN THE TREATMENT OF BIPOLAR MANIA SEDATION OF NON-INTUBATED PATIENTS PRIOR TO AND/OR DURING SURGICAL AND OTHER PROCUDURES EXPANSION OF INDICATION TO INCLUDE TREATMENT OF HIV IN TREATMENT NAIVE ADULTS TREATMENT OF MODERATE TO SEVERE DYSPAREUNIA, A SYMPTOM OF VULVAR AND VAGINAL ATROPHY, DUE TO MENOPAUSE AND NEW TWICE WEEKLY DOSING REGIMEN FOR THIS INDICATION INDOLENT B-CELL NON-HODGKINS LYMPHOMA (NHL) THAT HAS PROGRESSED DURING OR WITHIN SIX MONTHS OF TREATMENT WITH RITUXIMAB OR A RITUXIMAB CONTAINING REGIMEN TREATMENT TO INCREASE BONE MASS IN MEN WITH OSTEOPOROSIS TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE ADJUVANT TREATMENT OF ADULT PATIENTS FOLLOWING COMPLETE GROSS RESECTION OF KIT (CD117) POSITIVE GASTOINTESTINAL STROMAL TUMORS (GIST) TREATMENT AND PREVENTION OF GLUCOCORTICOID-INDUCED OSTEOPOROSIS IN PATIENTS EXPECTED TO BE ON GLUCOCORTICOIDS FOR AT LEAST 12 MONTHS TREATMENT OF SHORT STATURE IN PEDIATRIC PATIENTS SMALL FOR GESTATIONAL AGE WHO DO NOT MANIFEST CATCH UP GROWTH BY AGE 2 TO 4 YEARS COMMUNITY ACQUIRED BACTERIAL PNEUMONIA ADDITIONAL PATHOGENS TO COMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS INDICATION ADDITIONAL PATHOGENS TO COMPLICATED INTRA-ABDOMINAL INFECTIONS INDICATION TREATMENT OF TREATMENT RESISTANT DEPRESSION (TRD) IN COMBINATION WITH OLANZAPINE ACUTE TREATMENT OF DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR DISORDER (IN COMBINATION WITH OLANZAPINE) TREATMENT OF TREATMENT RESISTANT DEPRESSION (TRD) IN COMBINATION WITH FLUOXETINE ACUTE TREATMENT OF DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR DISORDER (IN COMBINATION WITH FLUOXETINE) TREATMENT OF TREATMENT RESISTANT DEPRESSION (TRD) INDICATION EXPANDED TO INCLUDE PATIENTS WHO HAVE EXPERIENCED A FIRST CLINICAL EPISODE AND HAVE MRI FEATURES CONSISTENT WITH MULTIPLE SCLEROSIS PREVENTION OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN USE AS ADJUNCTIVE THERAPY WITH LITHIUM OR VALPROATE FOR THE MAINTENANCE TREATMENT OF BIPOLAR I DISORDER MONOTHERAPY FOR THE MAINTENANCE TREATMENT OF BIPOLAR I DISORDER

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

EXCLUSIVITY INDICATION
I-598 I-599 I-600 I-601

ADB 19 of 51

I-602 I-603 I-604 I-605 I-606 I-607 I-608

I-610 I-611

I-612

I-613 I-614 I-615 I-616 I-617 I-618 I-619 I-620

I-621

I-622 I-623 I-624

I-625 I-626 I-627 I-628 I-629 I-630

I-631 I-632 I-633 I-634

TREATMENT OF PULMONARY ARTERIAL HYPERTENSION INDICATION EXPANDED TO INCLUDE DELAY IN CLINICAL WORSENING PREVENTION AND TREATMENT OF SECONDARY HYPERPARATHYROIDISM ASSOCIATED WITH CHRONIC KIDNEY DISEASE (CKD) STAGE 5 IN PATIENTS ON HEMODIALYSIS OR PERITONEAL DIALYSIS FOR USE AS INITIAL THERAPY IN PATIENTS WHO ARE LIKELY TO NEED MULTIPLE DRUGS TO ACHIEVE THEIR BLOOD PRESSURE GOALS MAINTENANCE TREATMENT IN PATIENTS WITH ADVANCED OR METASTATIC NONSQUAMOUS NON-SMALL CELL LUNG CANCER WHOSE DISEASE HAS NOT PROGRESSED AFTER FOUR CYCLES OF PLATINUM-BASED FIRST LINE CHEMOTHERAPY TREATMENT OF MEN AND WOMEN WITH OSTEOPOROSIS ASSOCIATED WITH SUSTAINED SYSTEMIC GLUCOCORTICOID THERAPY AT HIGH RISK FOR FRACTURE GOUT FLARES PREVENTION OF CMV DISEASE IN KIDNEY AND HEART TRANSPLANT PATIENTS 4 MONTHS TO 16 YEARS AT HIGH RISK ADJUNCT TO MOOD STABILIZERS AND/OR ANTIDEPRESSANTS FOR SCHIZOAFFECTIVE DISORDER TREATMENT OF SCHIZOAFFECTIVE DISORDER AS MONOTHERAPY INDICATION EXPANDED TO INCLUDE TREATMENT OF PULMONARY ARTENAL HYPERTENSION (WHO GROUP I) IN PATIENTS WITH CLASS II SYMPTOMS REDUCE LDL-C LEVELS IN BOYS AND POSTMENARCHAL GIRLS, 10 TO 17 YEARS OF AGE, WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA AS MONOTHERAPY OR IN COMBINATION WITH A STATIN AFTER FAILING AN ADEQUATE TRIAL OF DIET THERAPY TREATMENT OF HEAVY MENSTRUAL BLEEDING FOR WOMEN WHO CHOOSE TO USE INTRAUTERINE CONTRACEPTION AS THEIR METHOD OF CONTRACEPTION TREATMENT OF HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA IN ADOLESCENT BOYS AND POSTMENARCHAL GIRLS, AGES 10 TO 17 YEARS, WITH A RECOMMENDATION DOSING RANGE OF 5 TO 20 MG ONCE DAILY MICARDIS 80 MG FOR REDUCTION OF THE RISK OF MYOCARDIAL INFARCTION, STROKE, OR DEATH FROM CARDIOVASCULAR CAUSES IN PATIENTS 55 YEARS OF AGE OR OLDER AT HIGH RISK OF DEVELOPING MAJOR CARDIOVASCULAR EVENTS WHO ARE UNABLE TO TAKE ACE INHIBITORS MILD TO MODERATE ATOPIC DERMATITIS IN PATIENTS 3 MONTHS OF AGE TO LESS THAN 18 YEARS OF AGE SHORT TERM TREATMENT OF EROSIVE ESOPHAGITIS ASSOCIATED WITH GERD IN PEDIATRIC PATIENTS AGES FIVE YEARS AND OLDER MAINTENANCE TREATMENT OF BIPOLAR DISORDER AS AN ADJUNCT TO LITHIUM OR VALPROATE TREATMENT OF IRRITABILITY ASSOCIATED WITH AUTISTIC DISORDER IN PEDIATRIC PATIENTS AGES 617 YEARS OF AGE MAINTENANCE OF GENERALIZED ANXIETY DISORDER (GAD) ADJUNCTIVE THERAPY IN THE TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD) INTRAVENOUS CONTRAST ENHANCED COMPUTER TOMOGRAPHY OF THE HEAD AND BODY FOR USE IN COMBINATION WITH LETROZOLE FOR THE TREATMENT OF POSTMENOPAUSAL WOMEN WITH HORMONE RECEPTOR POSITIVE METASTATIC BREAST CANCER THAT OVEREXPRESSES THE HER2 RECEPTOR FOR WHOM HORMONAL THERAPY IS INDICATED PRIMARY PREVENTION OF CARDIOVASCULAR DISEASE, BASED ON THE RESULTS OF JUSTIFICATION FOR THE USE OF STATINS IN PRIMARY PREVENTION; AN INTERVENTION TRIAL EVALUATING ROSUVASTATIN (JUPITER) ADJUNCTIVE THERAPY FOR PRIMARY GENERALIZED TONIC-CLONIC SEIZURES IN PATIENTS THIRTEEN YEARS OF AGE AND OLDER TREATMENT OF SIGNS AND SYMPTOMS OF ADVANCED IDIOPATHIC PARKINSON'S DISEASE MAINTENANCE TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER WHOSE DISEASE HAS NOT PROGRESSED AFTER FOUR CYCLES OF PLATINUM-BASED FIRSTLINE CHEMOTHERAPY PANCREATIC INSUFFICIENCY DUE TO CHRONIC PANCREATITIS AND PANCREATECTOMY RELIEF OF NASAL CONGESTION ASSOCIATED WITH SEASONAL ALLERGIC RHINITIS IN ADULTS AND PEDIATRIC PATENTS 2 YEARS OF AGE AND OLDER TREATMENT OF NEWLY DIAGNOSED ADULT PATIENTS WITH PHILADELPHIA CHROMOSOME POSITIVE CHRONIC MYELOID LEUKEMIA (PH & CML) IN CHRONIC PHASE. MAINTENANCE TREATMENT OF SCHIZOPHRENIA IN ADULTS ADJUNCTIVE THERAPY WITH EITHER LITHIUM OR VALPROATE FOR THE ACUTE TREATMENT OF MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER TREATMENT OF PATIENTS WITH SUBEPENDYMAL GIANT CELL ASTROCYTOMA (SEGA) ASSOCIATED WITH TUBEROUS SCLEROSIS (TS) WHO REQUIRE THERAPEUTIC INTERVENTION BUT ARE NOT CANDIDATES FOR CURATIVE SURGICAL RESECTION. PREVENTION OF RELAPSE TO OPIOID DEPENDENCE FOLLOWING OPIOID DETOXIFICATION MANAGEMENT OF CHRONIC MUSCULOSKELETAL PAIN MAINTENANCE TREATMENT OF BIPOLAR I DISORDER AS AN ADJUNCT TO LITHIUM OR VALPROATE TREATMENT OF SEVERE HYPERCALCEMIA IN PATIENTS WITH PRIMARY HYPERPARATHYROIDISM WHO ARE UNABLE TO UNDERGO PARATHYROIDECTOMY

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

EXCLUSIVITY INDICATION
I-635 I-636 I-637 I-638 I-639 I-640 I-641 I-642 I-643 I-644

ADB 20 of 51

ADJUNCTIVE TREATMENT WITH LONG-ACTING ORAL PSYCHOSTIMULANTS FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) TREATMENT OF EXTERNAL GENITAL AND PERIANAL WARTS/CONDYLOMA ACUMINATA IN PATIENTS 12 YEARS OR OLDER USE IN COMBINATION CHEMOTHERAPY WITH 5-FLUOROURACIL IN THE PALLIATIVE TREATMENT OF PATIENTS WITH ADVANCED METASTATIC COLORECTAL CANCER FOR PATIENTS WITH PROGRESSIVE NEUROENDOCRINE TUMORS OF PANCREATIC ORIGIN (PNET) THAT ARE UNRESECTABLE, LOCALLY ADVANCED, OR METASTATIC. TREATMENT OF PROGRESSIVE, WELL-DIFFERENTIATED PANCREATIC NEUROENDOCRINE TUMORS IN PATIENTS WITH UNRESECTABLE, LOCALLY ADVANCED, OR METASTATIC DISEASE MAINTENANCE OF REMISSION OF ULCERATIVE COLITIS TREATMENT OF THE SIGNS AND SYMPTOMS OF BENIGN PROSTATIC HYPERPLASIA (BPH) TREATMENT OF ERECTILE DYSFUNCTION (ED) AND THE SIGNS AND SYMPTOMS OF BENIGN PROSTATIC HYPERPLASIA (BPH) REDUCE THE RISK OF STROKE AND SYSTEMIC EMBOLISM IN PATIENTS WITH NONVALVULAR ATRIAL FIBRILLATION. MONOTHERAPY IN PATIENTS 13 YEARS OF AGE AND OLDER WITH PARTIAL SEIZURES WHO ARE RECEIVING THERAPY WITH A SINGLE ANTIEPILEPTIC DRUG (AED)

EXCLUSIVITY MISCELLANEOUS
M-1 M-2 INFORMATION REGARDING SUPERIORITY CLAIM OVER RANITIDINE FOR DAY AND NIGHT HEARTBURN ADDED TO CLINICAL STUDIES SECTION APPROVAL FOR ADDTION TO CLINICAL PHARMACOLOGY SECTION OF THE LABEL REGARDING (1) IMPROVEMENT IN BONE MINERAL DENSITY IN CHILDHOOD-ONSET ADULT GROWTH HORMONE DEFICIENT PATIENTS AND (2) INCREASES IN SERUM ALKALINE PHOSPHATASE ADDITION OF EFFICACY AND SAFETY INFORMATION IN WHICH FOSAMAX WAS USED CONCOMITANTLY WITH ESTROGEN ALONE OR WITH ESTROGEN PLUS PROGESTIN CHANGES TO PEDIATRIC USE SECTION TO PROVIDE INFORMATION REGARDING SAFETY AND EFFICACY IN PEDIATRIC PATIENTS AS YOUNG AS 2 YEARS OLD INFORMATION REGARDING EFFECTS IN PATIENTS WITH ASTHMA ON CONCOMITANT INHALED CORTICOSTEROIDS IN CLINICAL PHARMACOLOGY SECTION ADDITIONAL INFORMATION REGARDING CLINICAL STUDIES DONE WITH GLUCOPHAGE/GLYBURIDE COMBINATION ADDED TO CLINICAL PHARMACOLOGY AND DOSING AND ADMINISTRATION CLINICAL PHARMACOLOGY IN PEDIATRIC PATIENTS; DOSAGE AND ADMINISTRATION INFORMATION ADDITIONAL INFORMATION FOR THE USE OF SONATA CAPSULES FOR UP TO 5 WEEKS (35 NIGHTS) OF TREATMENT IN A CONTROLLED TRIAL SETTING ADDITION TO THE CLINICAL STUDIES SECTION OF THE LABELING OF TEXT AND TWO TABLES CONTAINING INFORMATION FOR THE PRESCRIBING PHYSICIAN ON BLOOD PRESSURE, HEART RATE, AND HEART RATE VARIABILITY INFORMATION REGARDING MAINTENANCE OF AN ANTIDEPRESSANT EFFECT UP TO 1 YEAR OF DOSING USE FOR LONG-TERM TREATMENT OF POSTTRAUMATIC STRESS DISORDER NEW LANGUAGE FOR PEDIATRIC USE INFORMATION FROM PEDIATRIC STUDIES ADDED TO CLINICAL PHARMACOLOGY, PRECAUTIONS, AND DOSAGE AND ADMINISTRATION ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION LONGER TERM EFFICACY INFORMATION FOR RISPERIDONE IN THE TREATMENT OF SCHIZOPHRENIA CHANGE IN WORDING OF THE PEDIATRIC SECTION OF THE PACKAGE INSERT INFORMATION REGARDING USE OF ULTANE IN PEDIATRIC PATIENTS WITH CONGENITAL HEART DISEASE INFORMATION DENOTING THE EFFICACY OF REMERON IN MAINTAINING A RESPONSE IN PATIENTS WITH MAJOR DEPRESSIVE DISORDER (MDD) INFORMATION REGARDING USE IN PEDIATRIC PATIENTS TWO YEARS OF AGE AND OLDER LABELING REVISIONS RELATED TO MCCUNE ALBRIGHT SYNDROME COMPARISON DATA ON THE ANTIHYPERTENSIVE EFFECTS OF ATACAND AND COZAAR CHANGE IN TIME TO ONSET OF ACTION INFORMATION REGARDING ELIMINATION ADDED TO CLINICAL PHARMACOLOGY, STUDY RESULTS IN PATIENTS WITH HEPATIC AND RENAL IMPAIRMENT INFORMATION ON RESULTS OF A LONG TERM LONGITUDINAL GROWTH STUDY AND PEDIATRIC SAFETY INFORMATION ADDITIONAL SAFETY & PK INFORMATION IN CHILDREN 6 MONTHS TO LESS THAN 6 YEARS OF AGE ADDED TO PKG INSERT INCORPORATION OF INFORMATION CONTAINED IN THE PEG-INTRON PACKAGE INSERT INTO THE REBETOL PACKAGE INSERT AND MEDGUIDE-PEG-INTRON WAS APPROVED FOR USE IN COMBINATION WITH REBETOL FOR TREATMENT OF CHRONIC HEPATITIS C VIRUS INFECTION ON 8/7/01 INFORMATION DESCRIBING ASPIRIN ENDOSCOPY STUDY AND THE MAXIMUM RECOMMENDED DOSE FOR PATIENTS WITH MODERATE HEPATIC INSUFFICIENCY

M-3 M-4 M-5 M-6 M-7 M-8 M-9

M-10 M-11 M-12 M-13 M-14 M-15 M-16 M-17 M-18 M-19 M-20 M-21 M-22 M-23 M-24 M-25 M-26

M-27

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

EXCLUSIVITY MISCELLANEOUS
M-28 M-29 M-30 M-31 M-32 M-33 M-34 M-35 M-36 M-37 M-38 M-39 M-40 M-41

ADB 21 of 51

M-42 M-43

M-44 M-45 M-46 M-47 M-48 M-49 M-50

M-51 M-52

M-53 M-54 M-55 M-56 M-57 M-58

M-59

M-60

M-61

INFORMATION FROM A STUDY IN PEDIATRIC PATIENTS IN ASSOCIATION WITH A NEUROLOGICAL CONDITION LABELING CHANGES TO PROVIDE INFORMATION IN THE MANAGEMENT OF OBESITY IN ADOLESCENTS AGED 12 TO 16 YEARS CHANGES TO CLINICAL PHARMACOLOGY, PRECAUTIONS, AND DOSAGE AND ADMINISTRATION SECTIONS OF LABELING CONCERNING USE OF LOTENSIN IN PEDIATRIC PATIENTS WITH HYPERTENSION INFORMATION FOR USE IN PEDIATRIC PATIENTS WITH CHRONIC KIDNEY DISEASE STAGE 5 (END-STAGE RENAL DISEASE) ADDITIONAL LANGUAGE TO CLINICAL PHARMACOLOGY AND CLINICAL STUDIES INFORMATION FOR USE OF ADVAIR DISKUS 100/50 IN CHILDREN 4 TO 11 YEARS OF AGE WITH ASTHMA EXPANDED INFORMATION TO PEDIATRIC USE SUBSECTION OF LABELING IN RESPONSE TO PEDIATRIC WRITTEN REQUEST ADDITIONAL INFORMATION REGARDING CLINICAL STUDIES DONE WITH ACTOS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, OR INSULIN ADDED TO CLINICAL PHARMACOLOGY ADDITION OF INFORMATION TO CLINICAL STUDIES REGARDING PREVENTION OF CARDIOVASCULAR DISEASE INFORMATION ADDED TO THE LABELING THAT DETAILS INFORMATION RELATIVE TO STUDIES DONE IN PEDIATRIC POPULATIONS IN THE CLINICAL PHARMACOLOGY AND PEDIATRIC USE SUBSECTIONS SAFETY AND IOP-LOWERING EFFECTS OF TRUSOPT HAVE BEEN DEMONSTRATED IN PEDIATRIC PATIENTS IN A 3 MONTH, MULTI-CENTER DOUBLE MASKED ACTIVE-TREATMENT-CONTROLLED TRIAL FOR LABELING CHANGES BASED ON RESULTS OF THE SPD422-202 CLINICAL STUDY REPORT (CSR) SUBMITTED IN RESPONSE TO THE WRITTEN REQUEST ADDITIONAL INFORMATION REGARDING CLINICAL STUDIES PERFORMED IN PEDIATRIC PATIENTS WITH LEUKEMIA ADDED TO PRECAUTIONS REVISION TO THE PEDIATRIC USE PRECAUTIONS OF THE PRESCRIBING INFORMATION TO INCORPORATE THE RESULTS FROM THE CAPPS-169 STUDY ENTITLED "THE EFFECT OF ORTHO TRICYCLEN ON BONE MINERAL DENISTY IN PEDIATRIC SUBJECTS WITH ANOREXIA NERVOSA" ADDITION OF A GERIATRIC USE SUBSECTION TO THE PRECAUTIONS SECTION OF THE PACKAGE INSERT AND GERIATRIC DOSING INFORMATION INCLUSION OF RESULTS OF STUDY-"PLACEBO-CONTROLLED STUDY TO EVALUATE SAFETY AND PILOT EFFICACY OF ILOPROST AS ADD ON THERAPY WITH BOSENTAN IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION CLINICAL INFORMATION ADDED TO THE PEDIATRIC USE SUBSECTION OF PRECAUTIONS REGARDING THE USE OF NOVOLOG IN ADOLESCENTS WITH TYPE I DIABETES AGE 6 TO 18 INFORMATION ADDED TO CLINICAL TRIALS SECTION OF LABELING - EFFECTS OF HUMATROPE TREATMENT IN ADULTS WITH GROWTH HORMONE DEFICIENCY PROVISION OF RESULTS OF STUDY AND PROPOSED REVISIONS TO PACKAGE INSERT SEE SECTION ON CARDIAC ELECTROPHYSIOLOGY PROVIDES FOR USE OF ANTARA WITHOUT REGARD TO MEALS CHANGES TO THE LABELING DESCRIBING THE RESULTS OF A STUDY OF THE USE OF NOVOLOG MIX 70/30 WITH ORAL ANTIDIABETIC AGENTS IN PATIENTS WITH TYPE 2 DIABETES CLINICAL DATA ADDED TO THE CLINICAL PHARMACOLOGY SECTION REGARDING EFFECT OF SINGULAIR ON GROWTH RATES IN PREPUBERTAL CHILDREN NEW INFO TO THE CLINICAL STUDIES, ADULT GROWTH HORMONE DEFICIENCY (GHD) SUBSECTION OF THE NUTROPIN AQ PACKAGE INSERT DESCRIBING THE EFFECTS OF SOMATROPIN ON VISCERAL ADIPOSE TISSUE IN THE ADULT GROWTH HORMONE DEFICIENT PATIENT POPULATION INFORMATION ADDED TO LABELING REGARDING OSTEOGENESIS IMPERFECTA STUDY INFORMATION ADDED TO THE CLINICAL PHARMACOLOGY/CLINICAL STUDIES SECTION REGARDING THE USE OF RISEDRONATE ADMINISTERED ONCE A WEEK IN THE PREVENTION OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN FOR LABELING CHANGES TO THE QUALITY OF LIFE (QOL) STATEMENT IN THE APPROVED PACKAGE INSERT INFORMATION FROM PEDIATRIC STUDIES ADDED TO LABEL INFORMATION ON RESULTS OF A STUDY OF THE USE OF SANDOSTATIN LAR DEPOT IN PEDIATRIC PATIENTS WITH HYPOTHALAMIC OBESITY. INFORMATION ADDED TO CLINICAL TRIAL SECTION WITH INFORMATION ON "GEMINI" TRIAL CLINICAL DATA ADDED TO THE CLINICAL PHARMACOLOGY SECTION REGARDING THE PHARMACOKINETICS OF EZETIMIBE IN ASIAN SUBJECTS CHANGES TO THE CLINICAL STUDIES, PRIMARY HYPERCHOLESTEROLEMIA, VYTORIN SUBSECTION OF THE PACKAGE INSERT TO ADD EFFICACY DATA FOR THE EZETIMIBE/SIMVASTATIN COMBINATION PRODUCT AND FOR AN ATORVASTATIN PRODUCT ON LDL-C AND OTHER LIPID PRMTRS RESULTS OF THE T20-310 STUDY WHICH EVALUATED THE PHARMACOKINETICS, SAFETY, AND ANTIVIRAL ACTIVITY OF FUZEON IN TREATMENT EXPERIENCED PEDIATRIC SUBJECTS AND ADOLSCENTS WAS ADDED TO THE PEDIATRIC SUBSECTION OF PRECAUTIONS CHANGES TO CLINICAL STUDIES, PRIMARY HYPERCHOLESTEROLEMIA, TO ADD EFFICACY DATA FOR THE EZETIMIBE/SIMVASTATIN COMBINATION PRODUCT AND FOR A ROSUVASTATIN PRODUCT ON LDL-C AND OTHER LIPID PARAMETERS IN PATIENTS WTH HYPERCHOLESTEROLEMIA REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

EXCLUSIVITY MISCELLANEOUS
M-62

ADB 22 of 51

M-63 M-64 M-65 M-66 M-67 M-68 M-69 M-70 M-71 M-72 M-73 M-74 M-75 M-76

M-77

M-78 M-79 M-80 M-81

M-82 M-83 M-84 M-85 M-86

M-87 M-88 M-89 M-90 M-91

M-92

M-93

M-94 M-95

CLINICAL INFORMATION FROM ONE CLINICAL STUDY INVESTIGATING THE USE OF AVANDAMET PLUS INSULIN IN PATIENTS WITH TYPE 2 DIABETES MELLITUS WHO HAVE NOT ACHIEVED ADEQUATE GLYCEMIC CONTROL WITH PREVIOUS ANTI-DIABETIC THERAPIES DETAILED INFORMATION ON AN INCONCLUSIVE PEDIATRIC STUDY CHANGES TO CLINICAL PHARMACOLOGY DETAILING STUDY RESULTS ADDITION OF INFORMATION TO LABEL TO INCLUDE INFORMATION REGARDING USE IN PATIENTS WITH HIV-ASSOCIATED ADIPOSE REDISTRIBUTION SYNDROME (HARS) USE IN SPECIFIC POPULATIONS - PATIENTS WITH CONCOMITANT ILLNESS SUBSECTION OF THE LABELING REGARDING USE OF STRATTERA IN PATIENTS WITH ADHD WHO HAVE COMORBID TIC DISORDER INDICATION EXPANDED TO INCLUDE PATIENTS ON PERITONEAL DIALYSIS DESCRIPTION OF RESULTS OF STUDY OF INITIAL THERAPY IN COMBINATION WITH METFORMIN WHEN DIET AND EXERCISE DO NOT PROVIDE GLYCEMIC CONTROL RESULTS OF STUDY OF COMBINATION THERAPY AND NON-INFERIORITY STUDY PROVISION OF INFORMATION OF THE RESULTS OF A PHASE 2 RANDOMIZED TRIAL OF SPRYCEL 70MG TWICE DAILY OR IMATINIB 800MG DAILY REVISIONS TO PROVIDE FOR RESULTS OF MAINTENANCE DATA IN ADULT PATIENTS WITH MAJOR DEPRESSIVE DISORDER INFORMATION ABOUT USE OF INSPRA (EPLERENONE) FOR HYPERTENSION IN PEDIATRIC PATIENTS NEW INFORMATION ADDED REGARDING THE TUMOR SHRINKING POTENTIAL OF SANDOSTATIN LAR DEPOT INJECTION ON GH - SECRETING PITUITARY ADENOMAS REVISIONS TO CLINICAL STUDIES - CHILDREN AND ADOLSCENTS BASED ON CLINICAL TRIAL DATA TO SUPPORT A DURATION OF ACTION CLAIM UP TO 12 HOURS PROVISION FOR USE OF ARGAGATROBAN IN CERTAIN PEDIATRIC PATIENTS WITH HEPARIN-INDUCED THROMBOCYTOPENIA (HIT) OR HEPARIN-INDUCED THROMBOCYTOPENIA WITH THROMBOSIS (HITTS) REMOVAL OF SCREEN REQUIREMENT IN PTS WITH G6PD DEFICIENCY PRIOR TO INITIATING ACZONE TREATMENT; REMOVAL OF BLOOD COUNT & RETICULOCYTE MONITORING DURING TREATMENT IN G6PD DEFICIENT PTS AND IN PATIENTS WITH HISTORY OF ANEMIA USE IN COMBINATION WITH THE NEW AKTILITE CL128 LAMP FOR THE TREATMENT OF THIN AND MODERATELY THICK, NON-HYPERKERATOTIC, NON-PIGMENTED ACTINIC KERATOSES OF THE FACE AND SCALP IN IMMUNOCOMPETENT PATIENTS CLINICAL TRIAL INFO ON USE OF STRATTERA IN PATIENTS WITH ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) AND COMORBID ANXIETY DISORDER WITHOUT CAUSING WORSENING OF ANXIETY LABELING REVISIONS RELATED TO SMOKING AND ERLOTIMB EXPOSURE ADDITIONAL TIME POINT OF 30 MINUTES (0.5 HOUR) IN CHILDREN AGED 6-12 YEARS WITH A DIAGNOSIS OF ATTENTION-DEFICIT HYPERACTIVITY DISORDER (ADHD) ADDITIONAL INFO FOR PEDIATRIC USE FOR CASODEX (STUDIED IN COMBINATION WITH ARIMIDEX) IN THE PEDIATRIC POPULATION, SPECIFICALLY BOYS WITH FAMILIAL MALE-LIMITED PRECOCIOUS PUBERTY (TESTOXICOSIS) LABELING REVISIONS RELATED TO CLINICAL STUDIES ADDITIONAL INFORMATION ADDED TO LABELING REGARDING ESTABLISHMENT OF EFFICACY IN ADDITIONAL CLINICAL TRIALS AND ONE MAINTENANCE TRIAL STUDY INFORMATION ADDED TO LABEL REGARDING BONE MINERAL DENSITY INFORMATION ADDED TO LABELING REGARDING USE OF PREVACID IN PATIENTS LESS THAN 1 YEAR WITH SYMPTOMATIC GERD LABELING CHANGES SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST FOR INFANTS AGES BIRTH TO 11 MONTH INCLUSIVE REFLECTING LACK OF EFFICACY FOR GERD INDICATION FOR THIS PATIENT POPULATION INCLUSION OF RESULTS FROM TWO DRUG INTERACTION STUDIES WITH LIPITOR AND CRESTOR IN CLINICAL PHARMACOLOGY SECTION ADDITION OF INFORMATION REGARDING ABUSE POTENTIAL OF CONCERTA VERSUS IMMEDIATE-RELEASE METHYLPHENIDATE PROVIDES FOR REVISIONS TO MULTIPLE SECTIONS OF THE PACKAGE INSERT TO REFLECT RESULTS OF CLINICAL TRIALS 205.235 (UPLIFT) AND 205.266 (VA STUDY) IN SUPPORT OF EXACERBATION CLAIM LABELING CHANGES BASED ON DATA FROM CLINICAL STUDIES NV20235 AND NV20236 STUDIES OF SEASONAL PROPHYLAXIS OF INFLUENZA IN IMMUNOCOMPROMISED PATIENTS AND CHILDREN AGES 1-12 UPDATED LABELING BASED UPON STUDY: A SINGLE-DOSE, SINGLE-BLIND, PLACEBO-AND MOXIFLOXACIN-CONTROLLED 2-PERIOD, RANDOMIZED, CROSSOVER, 3RD PERIOD SEQUENTIAL STUDY OF SIDE EFFECTS OF TEMSIROLIMUS ON CARDIAC REPOLARIZATION IN HEALTHY SUBJECTS UPDATES TO THE PACKAGE INSERT BASED UPON THE TRIAL ENTITLED "A PHASE I PHARMACOKINETIC AND PHARMACODYNAMIC STUDY OF TEMSIROLIMUS IN PATIENTS WITH ADVANCED MALIGNANCIES AND NORMAL AND IMPAIRED LIVER FUNCTION EXPANSION OF LABELING TO INCLUDE INFORMATION ON SAFETY AND EFFICACY OF CREON IN PATIENTS AGES 7 YEARS THROUGH 11 YEARS WITH PANCREATIC EXOCRINE INSUFFICIENCY DUE TO CYSTIC FIBROSIS INFO ADDED TO LABEL RELATED TO NEWLY DIAGNOSED PHILADELPHIA CHROMOSOME POSITIVE (PH+) CHRONIC MYELOID LEUKEMIA IC CHRONIC PHASE INFORMATION FOR TREATMENT OF CHRONIC HEPATITIS B (CHB) IN ADULT PATIENTS WITH DECOMPENSATED LIVER DISEASE BASED ON DATA FROM CLINICAL TRIAL GS-US-174-0108

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

EXCLUSIVITY MISCELLANEOUS
M-96

ADB 23 of 51

M-97 M-98 M-99

M-100 M-101 M-102

M-103

M-104 M-105

M-106 M-107

M-108

UPDATED INFORMATION IN THE CLINICAL STUDIES SECTION RELATED TO THE LOSS AND RECOVERY OF BONE MINERAL DENSITY IN ADOLESCENT GIRLS DURING AND FOLLOWING THE USE OF DEPO-PROVERA CONTRACEPTIVE INJECTION LABELING CHANGES IN RESPONSE TO PEDIATRIC STUDIES - NOT INDICATED FOR USE IN PEDIATRIC POPULATION NEW INFORMATION FROM A STUDY WHICH EVALUATED THE SAFETY AND EFFICACY OF FAMVIR IN TREATING RECURRENT GENITAL HERPES IN IMMUNOCOMPETENT BLACK/AFRICAN AMERICAN SUBJECTS. ADDITION OF FINDINGS FROM A SINGLE PEDIATRIC CLINICAL TRIAL (P04292) OF NASONEX NASAL SPRAY IN THE TREATMENT OF NASAL POLYPS IN PATENTS 6 TO <18 YEARS OF AGE TO THE PACKAGE INSERT. INFORMATION ADDED TO LABEL BASED UPON COMPLETED CLINICAL TRIAL REPORTS INCLUSION OF DATA FROM AN ADDITIONAL 19 SUBJECTS WITH HYPERCALCEMIA FROM PARATHYROID CARCINOMA TO THE INFORMATION CURRENTLY PRESENTED IN THE LABEL INFORMATION FROM PEDIATRIC STUDY REPORT ML16633, "INTRAVENOUS GRANISETRON (KYTRIL) IN THE PREVENTION OF POST-OPERATIVE NAUSEA AND VOMITING (PONV) IN PEDIATRIC SUBJECTS UNDERGOING TONSILLECTOMY OR ADENOTONSILLECTOMY." SAFETY, EFFICACY AND PHARMACOKINETIC INFO FOR FASLODEX IN THE PEDIATRIC POPULATION, SPECIFICALLY FOR GIRLS WITH PROGRESSIVE PRECOCIOUS PUBERTY ASSOCIATED WITH MCCUNEALBRIGHT SYNDROME ADDED TO THE PEDIATRIC USE SECTION OF THE LABELING INFORMATION ADDED TO DOSING AND ADMINISTRATION REGARDING A 26 WEEK STUDY NEW LANGUAGE ADDED TO CLINICAL STUDIES REGARDING USE IN SMOKERS WITH CARDIOVASCULAR DISEASE, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, AND USE ACCORDING TO AN ALTERNATIVE SET OF DIRECTIONS FOR SETTING A QUIT DATE ADDITION OF THE T1-WEIGHTED GD-ENHANCED LESION EFFICACY VARIABLE IN THE CLINICAL STUDIES SECTION 14 OF THE PACKAGE INSERT INFORMATION TO THE CLINICAL STUDIES SECTION OF THE LUPRON DEPOT-PED,1-MONTH,BASED UPON THE PHASE 3/4 COMPLETED CLINICAL STUDY REPORT FOR STUDY M90-516, ENTITLED "STUDY OF LUPRON DEPOT IN THE TREATMENT OF CENTRAL PRECOCIOUS PUBERTY". CHANGES ARE BASED ON RESULTS FROM STUDY CV181057

PATENT USE
U-1 U-2 U-3 U-4 U-5 U-6 U-7 U-8 U-9 U-10 U-11 U-12 U-13 U-14 U-15 U-16 U-17 U-18 U-19 U-20 U-21 U-22 PREVENTION OF PREGNANCY TREATMENT OR PROPHYLAXIS OF ANGINA PECTORIS AND ARRHYTHMIA TREATMENT OF HYPERTENSION PROVIDING PREVENTION AND TREATMENT OF EMESIS AND NAUSEA IN MAMMALS METHOD OF PRODUCING BRONCHODILATION METHOD OF PRODUCING SYMPATHOMIMETIC EFFECTS INCREASING CARDIAC CONTRACTILITY ACUTE MYOCARDIAL INFARCTION CONTROL OF EMESIS ASSOCIATED WITH ANY CANCER CHEMOTHERAPY AGENT DIAGNOSTIC METHOD FOR DISTINGUISHING BETWEEN HYPOTHALMIC MALFUNCTIONS OR LESIONS IN HUMANS TREATMENT OR PROPHYLAXIS OF CARDIAC DISORDERS METHOD OF TREATING [A] HUMAN SUFFERING FROM DEPRESSION A METHOD FOR TREATING ANXIETY IN A HUMAN SUBJECT IN NEED OF SUCH TREATMENT ADJUNCTIVE THERAPY FOR THE PREVENTION AND TREATMENT OF HYPERAMMONEMIA IN THE CHRONIC MANAGEMENT OF PATIENTS WITH UREA CYCLE ENZYMOPATHIES METHOD OF LOWERING INTRAOCULAR PRESSURE USE IN LUNG SCANNING PROCEDURES TREATMENT OF VENTRICULAR AND SUPRAVENTRICULAR ARRHYTHMIAS METHOD FOR INHIBITING GASTRIC SECRETION IN MAMMALS TREATMENT OF INFLAMMATION A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSON'S SYNDROME AND IN NEED OF TREATMENT TREATMENT OF HUMANS SUFFERING UNDESIRED UROTOXIC SIDE EFFECTS CAUSED BY CYTOSTATICALLY ACTIVE ALKYLATING AGENTS METHOD OF COMBATTING PATHOLOGICALLY REDUCED CEREBRAL FUNCTIONS AND PERFORMANCE WEAKNESSES, CEREBRAL INSUFFICIENCY AND DISORDERS IN CEREBRAL CIRCULATION AND METABOLISM IN WARM-BLOODED ANIMALS METHOD FOR TREATING PROSTATIC CARCINOMA COMPRISING ADMINISTERING FLUTAMIDE METHOD FOR TREATING PROSTATE ADENOCARCINOMA COMPRISING ADMINISTERING AN ANTIANDROGEN INCLUDING FLUTAMIDE AND AN LHRH AGONIST REDUCING CHOLESTEROL IN CHOLELITHIASIS PATIENTS REDUCING CHOLESTEROL GALLSTONES AND/OR FRAGMENTS THEREOF DISSOLVING CHOLESTEROL GALLSTONES AND/OR FRAGMENTS THEREOF

U-23 U-24 U-25 U-26 U-27

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

PATENT USE
U-28 U-29 U-30 U-31 U-32 U-33 U-34 U-35 U-36 U-37 U-38 U-39 U-40 U-41 U-42 U-43 U-44 U-45 U-46 U-47 U-48 U-49 U-50 U-51 U-52 U-53 U-54 U-55 U-56 U-57 U-58 U-59 U-60 U-61 U-62 U-63 U-64 U-65 U-66 U-67 U-68 U-69 U-70 U-71 U-72 U-73 U-74 U-75 U-76 U-77 U-78 U-79 U-80 U-81 U-82 U-83

ADB 24 of 51

CEREBRAL, CORONARY, PERIPHERAL, VISCERAL AND RENAL ARTERIOGRAPHY, AORTOGRAPHY AND LEFT VENTRICULOGRAPHY CT IMAGING OF THE HEAD AND BODY, AND INTRAVENOUS EXCRETORY UROGRAPHY CEREBRAL ANGIOGRAPHY, AND VENOGRAPHY INTRA-ARTERIAL DIGITAL SUBTRACTION ANGIOGRAPHY PALLIATIVE TREATMENT OF PATIENTS WITH OVARIAN CARCINOMA RECURRENT AFTER PRIOR CHEMOTHERAPY, INCLUDING PATIENTS WHO HAVE BEEN PREVIOUSLY TREATED WITH CISPLATIN TREATING VIRAL INFECTIONS IN A MAMMAL TREATING VIRAL INFECTIONS IN A WARM-BLOODED ANIMAL TREATING CYTOMEGALOVIRUS IN A HUMAN WITH AN INJECTABLE COMPOSITION METHODS OF TREATING BACTERIAL ILLNESSES METHOD OF TREATING GASTROINTESTINAL DISEASE TREATMENT OF PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA ANGINA PECTORIS METHOD OF TREATMENT OF BURNS METHOD OF TREATING CARDIAC ARRHYTHMIAS ADJUVANT TREATMENT IN COMBINATION WITH FLUOROURACIL AFTER SURGICAL RESECTION IN PATIENTS WITH DUKES' STAGE C COLON CANCER MANAGEMENT OF CHRONIC PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA RELIEF OF NAUSEA AND VOMITING TREATMENT OF INFLAMMATION AND ANALGESIA TREATMENT OF PANIC DISORDER STIMULATION OF THE RELEASE OF GROWTH HORMONE ANALGESIA SYMPTOMATIC CANCER-RELATED HYPERCALCEMIA USE IN TREATING INFLAMMATORY DERMATOSES BLOOD POOL IMAGING, INCLUDING CARDIAC FIRST PASS AND GATED EQUILIBRIUM IMAGING AND FOR DETECTION OF SITES OF GASTROINTESTINAL BLEEDING TREATMENT OF ADULT AND PEDIATRIC PATIENTS(OVER SIX MONTHS OF AGE) WITH ADVANCED HIV INFECTION HYPERCALCEMIA OF MALIGNANCY REVERSAL AGENT OR ANTAGONIST OF NONDEPOLARIZING NEUROMUSCULAR BLOCKING AGENTS TREATMENT OF PAIN AID TO SMOKING CESSATION OPHTHALMIC USE OF NORFLOXACIN METHOD OF TREATING INFLAMMATORY INTESTINAL DISEASES METHOD OF TREATING HYPERCHOLESTEROLEMIA NASAL ADMINISTRATION OF BUTORPHANOL CEREBRAL AND PERIPHERAL ARTERIOGRAPHY AND CT IMAGING OF THE HEAD CORONARY ARTERIOGRAPHY, LEFT VENTRICULOGRAPHY, CT IMAGING OF THE BODY, INTRAVENOUS EXCRETORY UROGRAPHY, INTRAVENOUS DIGITAL SUBTRACTION ANGIOGRAPHY AND VENOGRAPHY ISOPRENALINE ANTAGONISM ON THE HEART RATE OR BLOOD PRESSURE TREATMENT OF VIRAL INFECTIONS METHOD OF TREATMENT OF A PATIENT INFECTED WITH HIV TRIPHASIC REGIMEN METHOD OF INDUCING ANESTHESIA IN A WARM BLOODED ANIMAL TREATMENT OF ACTINIC KERATOSIS TREATMENT OF PNEUMOCYSTIS CARINII INFECTIONS TREATMENT OF TRANSIENT INSOMNIA METHOD OF TREATMENT OF HEART FAILURE TREATMENT OF MIGRAINE METHOD OF TREATING DISEASES OR INFECTIONS CAUSED BY MYCETES METHOD OF PROVIDING HYPNOTIC EFFECT RELIEF OF OCULAR ITCHING DUE TO SEASONAL ALLERGIC CONJUNCTIVITIS USE TO IMAGE A SUBJECT WITH A MAGNETIC RESONANCE IMAGING SYSTEM TREATMENT OF SYMPTOMS OF SEASONAL ALLERGIC RHINITIS ULCERATIVE COLITIS SYMPTOMATIC TREATMENT OF PATIENTS WITH NOCTURNAL HEARTBURNDUE TO GERD METHOD OF TREATING OCULAR BACTERIAL INFECTIONS RELIEF OF SYMPTOMS ASSOCIATED WITH SEASONAL ALLERGIC RHINITIS TREATMENT FOR DEMENTIA IN PATIENTS WITH ALZHEIMER'S DISEASE TREATMENT OF SEIZURES

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

PATENT USE
U-84 U-85 U-86 U-87 U-88 U-89 U-90 U-91 U-92 U-93 U-94

ADB 25 of 51

U-95 U-96 U-97 U-98 U-99 U-100 U-101 U-102 U-103 U-104 U-105 U-106 U-107 U-108

U-109

U-110 U-111 U-112 U-113 U-114 U-115 U-116 U-117 U-118 U-119 U-120 U-121 U-122 U-123 U-124 U-125 U-126 U-127 U-128 U-129 U-130 U-131 U-132

A METHOD OF BLOCKING THE UPTAKE OF MONOAMINES BY BRAIN NEURONS IN ANIMALS NASAL TREATMENT OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS SYMPTOMS METHOD OF TREATING CERTAIN FORMS OF EPILEPSY METHOD FOR NONINVASIVE ADMINISTRATION OF SEDATIVES, ANALGESICS, AND ANESTHETICS TREATMENT OF MODERATE PLAQUE PSORIASIS TREATMENT OR PROPHYLAXIS OF EMESIS TREATMENT OF PYSCHOTIC DISORDERS ALTERNATIVE THERAPY TO TRIMETHOPRIM-SULFAMETHOXAZOLE FOR TREATMENT OF MODERATE-TO-SEVERE PNEUMOCYSTIS CARINII PNEUMONIA IN IMMUNOCOMPROMISED AND AIDS PATIENTS TREATMENT OF DIABETIC NEPHROPATHY IN PATIENTS WITH TYPE I INSULIN DEPENDENT DIABETES MELLITUS AND RETINOPATY USE AS AN ANTIHISTAMINE/DECONGESTANT TREATMENT-ADULTS W/ ADVANCED HIV,INTOLERANT OF APPROVED THERAPIES,INTOLERANT OF APPROVED THERAPIES W/PROVEN BENEFIT OR HAVE EXPERIENCED CLINICAL/IMMUNOLOGICAL DETERIORATION WHILE RECEIVING..OR FOR WHOM SUCH THERAPIES-CONTRAINDICATED SHORT TERM MANAGEMENT OF MODERATE PRURITIS IN ADULTS WITH ATOPIC DERMATITIS AND LICHEN SIMPLEX CHRONICUS METHOD OF TREATING VARICELLA ZOSTER (SHINGLES) INFECTIONS A METHOD OF TREATING A PATIENT IN NEED OF MEMORY ENHANCEMENT A METHOD OF INDUCING REGRESSION OF LEUKEMIA CELL GROWTH IN A MAMMAL METHOD OF PROVIDING POTASSIUM TO A SUBJECT IN NEED OF POTASSIUM METHOD OF TREATING OCULAR INFLAMMATION ADJUNCT TO CONVENTIONAL CT OR MRI IMAGING IN THE LOCALIZATION OF STROKE IN PATIENTS IN WHOM STROKE HAS ALREADY BEEN DIAGNOSED METHOD OF HORMONALLY TREATING MENOPAUSAL OR POST-MENOPAUSAL DISORDERS IN WOMEN TREATMENT OF OCULAR HYPERTENSION TREATMENT OF AQUEOUS HUMOR FORMATION AND INTRAOCULAR PRESSURE EMESIS TREATMENT OF EPILEPSY TREATMENT OF HYPERTENSION AND ANGINA PECTORIS SHORT-TERM TREATMENT OF ACTIVE DUODENAL ULCER, GASTROESOPHAGEAL REFLUX DISEASE (GERD), SEVERE EROSIVE ESOPHAGITIS, POORLY RESPONSIVE SYMPTOMATIC GERD AND PATHOLOGIAL HYPERSECRETORY CONDITIONS AND MAINTENANCE HEALING OF EROSIVE ESOPHAGITIS ADJUNCT DIET IN THE TX OF ELEVATED TOTAL CHOLESTEROL AND LDL-C LEVELS IN PTS W/PRIMARY HYPERCHOLESTEROLEMIA WHOSE RESPONSE TO DIETARY RESTRICTION OF SAT FAT AND CHOLESTEROL AND OTHER NONPHARMACOLOGICAL MEASURES HAS NOT BEEN ADEQUATE USE AS A RETRIEVABLE PERSSARY DIABETES CONTRACEPTION METHOD OF CONDUCTING RADIOLOGICAL EXAMINATION OF A PATIENT BY ADMINISTERING TO SAID PATIENT A RADIOPAQUE AMOUNT OF IOPROMIDE USE FOR INHIBITING BONE RESORPTION USE OF VASODILATORS TO EFFECT AND ENHANCE AN ERECTION (AND THUS TREAT ERECTILE DYSFUNCTION), BY INJECTION INTO THE PENIS METHOD OF MYOCARDIAL IMAGING TREATMENT OF OCULAR ALLERGIC RESPONSE IN HUMAN EYES METHOD OF LOWERING BLOOD SUGAR LEVEL TREATMENT OF NASAL HYPERSECRETION CONTROLLING OR PREVENTING POST-OPERATIVE INTRAOCULAR PRESSURE RISES ASSOCIATED WITH OPHTHALMIC LASER SURGICAL PROCEDURES METHOD OF TREATING CONDITIONS MEDIATED THROUGH HISTAMINE H2-RECEPTORS A THERAPEUTIC METHOD FOR CONTROLLING THROMBOSIS METHOD FOR CONTROLLING THROMBOSIS AND DECREASING BLOOD HYPERCOAGULATION AND HEMORRHAGING RISKS TREATMENT OF ACNE TREATMENT NEUROGENERATIVE DISEASES TREATMENT OF GASTRITIS METHOD OF PRODUCING NEUROMUSCULAR BLOCKADE METHOD FOR TREATMENT OF TUMORS METHOD TO DESTROY OR IMPAIR TARGET CELLS MANAGEMENT OF PATIENTS WITH MASTOCYTOSIS PHOTODAMAGED SKIN INHIBITING HIV PROTEASE

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

PATENT USE
U-133 U-134 U-135 U-136 U-137 U-138 U-139 U-140 U-141 U-142 U-143 U-144 U-145 U-146 U-147 U-148 U-149 U-150 U-151 U-152 U-153 U-154 U-155 U-156 U-157 U-158 U-159 U-160 U-161 U-162 U-163 U-164 U-165 U-166 U-167 U-168 U-169 U-170 U-171 U-172 U-173 U-174 U-175 U-176 U-177 U-178 U-179 U-180 U-181 U-182 U-183

ADB 26 of 51

MANAGEMENT OF OBESITY INCLUDING WEIGHT LOSS AND MAINTENANCE IN PATIENTS ON A REDUCEDCALORIE DIET TREATMENT OF ACNE VULGARIS ANTITUMOR AGENT PROCESS FOR WASTE NITROGEN REMOVAL METHOD OF TREATING BACTERIAL VAGINOSIS TREATMENT OF ALLERGIC RHINITIS TREATMENT OF ALLERGIC REACTIONS USE OF NORVIR TO INHIBIT HIV PROTEASE OR TO INHIBIT AN HIV INFECTION TREATMENT OF ULCERATIVE COLITIS METHOD OF TREATING ALLERGIC REACTIONS IN A MAMMAL BY USING THIS ACTIVE METABOLITE BIODEGRADABLE SUPERPARAMAGNETIC METAL OXIDES AS CONTRAST AGENTS FOR MR IMAGING BIOLOGICALLY DEGRADABLE SUPERPARAMAGNETIC MATERIALS FOR USE IN CLINICAL APPLICATIONS BIOLOGICALLY DEGRADABLE SUPERPARAMAGNETIC PARTICLES FOR USE AS NUCLEAR MAGNETIC RESONANCE IMAGING AGENTS METHOD OF TREATING SUSCEPTIBLE NEOPLASMS IN MAMMALS DETECTION OF GASTROINTESTINAL DISORDERS AND THE SUBSEQUENT BREATH COLLECTION AND MEASUREMENT OF 13CO2 DEVICE FOR COLLECTING A BREATH SAMPLE METHOD OF TREATING AN ANIMAL, INCLUDING A HUMAN SUFFERING FROM OR SUSCEPTIBLE TO PSYCHOSIS, ACUTE MANIA OR MILD ANXIETY STATES METHOD OF USE FOR CONTROLLING HYPERGLYCEMIA BY ADMINISTRATION OF THIS SUSTAINED RELEASE DOSAGE FORM OF GLIPIZIDE RELIEF OF SYMPTOMS OF THE COMMON COLD METHOD OF TREATING ANXIETY RELATED DISORDERS INCLUDING OBSESSIVE COMPULSIVE DISORDER TREATMENT OF INITIAL EPISODE GENITAL HERPES METHOD OF TREATING ANIMALS SUFFERING FROM AN APPETITE DISORDER TREATMENT OF ERECTILE DYSFUNCTION METHOD OF PROVIDING ANESTHESIA TREATMENT OF A HUMAN SUFFERING FROM VITAMIN B12 DEFICIENCY ANGINA TREATMENT OF INTERSTITIAL CYSTITIS TREATMENT OF BACTERIAL INFECTIOUS DISEASE METHOD OF INHIBITING CHOLESTEROL BIOSYNTHESIS IN A PATIENT METHOD OF USE TO INHIBIT CHOLESTEROL SYNTHESIS IN A HUMAN SUFFERING FROM HYPERCHOLESTEROLEMIA METHOD OF USING TROGLITAZONE TO TREAT IMPAIRED GLUCOSE TOLERANCE TO PREVENT OR DELAY THE ONSET OF NONINSULIN-DEPENDENT DIABETES MELLITUS METHOD OF USING TROGLITAZONE TO PREVENT OR DELAY THE ONSET OF NONINSULIN-DEPENDENT DIABETES MELLITUS IN A DEFINED POPULATION OF PATIENTS TREATMENT OF SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA TREATMENT OF H.PYLORI-ASSOCIATED DUODENAL ULCER METHOD FOR TREATING HIV-1 INFECTION METHOD OF INHIBITING LIPOXYGENASE ACTIVITY IN A MAMMAL WHICH IS THE MODE OF ACTION IN THE TREATMENT OF ASTHMA METHODS OF USING THE COMPOUND/DRUG PRODUCT AS A CONTRAST AGENT IN MAGNETIC RESONANCE IMAGING METHOD OF OBTAINING AN MR IMAGE USING THE COMPOSITION/DRUG PRODUCT AS A CONTRAST AGENT METHODS OF USING THE COMPOUND/DRUG PRODUCT AS AN ORAL CONTRAST AGENT IN MAGNETIC RESONANCE IMAGING OF THE GASTROINTESTINAL TRACT TREATMENT OF GENITAL WARTS ADMINISTRATION TO A HOST SUFFERING FROM GESTATIONAL DIABETES USE AS AN ANTIHISTAMINE AGENT METHOD OF TREATING MALIGNANT TUMORS METHOD OF TREATING A PATIENT SUFFERING FROM LISTED CONDITIONS, INCLUDING SPECIFIC PSYCHOSES FUNGICIDE FACILITATED ADHERENCE OF AGENTS TO SKIN ENHANCED CUTANEOUS PENETRATION OF A DERMALLY-APPLIED PHARMACOLOGICALLY ACTIVE AGENT TREATMENT OF ADULT AND PEDIATRIC PATIENTS (OVER 6 MONTHS OF AGE) WITH ADVANCED HIV INFECTION PRODUCING ALPHA ADRENERGIC ANTAGONISTIC ACTION IN A HOST USE OF SALMETEROL IN PATIENTS WITH REVERSIBLE AIRWAY OBSTRUCTION TREATMENT OF CONDITIONS CAUSED BY DISTURBANCE OF NEURONAL 5HT FUNCTION

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

PATENT USE
U-184 U-185 U-186 U-187 U-188 U-189 U-190 U-191 U-192 U-193 U-194 U-195 U-196 U-197 U-198

ADB 27 of 51

U-199 U-200 U-201 U-202 U-203 U-204 U-205 U-206 U-207 U-208 U-209 U-210 U-211 U-212 U-213 U-214 U-215 U-216 U-217 U-218 U-219 U-220 U-221 U-222 U-223 U-224 U-225 U-226 U-227 U-228 U-229 U-230 U-231

TREATING ALLERGIC EYE DISEASES IN HUMANS METHOD OF TREATING HYPERTENSION METHOD FOR TREATING GI DISORDERS CAUSED BY H.RYLORI WHICH COMPRISES ADMINISTRATION OF RANITIDINE BISMUTH CITRATE AND CLARITHROMYCIN FOR A GREATER THAN ADDITIVE EFFECT THERAPEUTIC TREATMENT OF CALCIFIC TUMORS TREATMENT OF H.PYLORI ASSOCIATED DUODENAL ULCER ENHANCEMENT OF THE BIOAVAILABILITY OF THE DRUG SUBSTANCE USE OF RITONAVIR IN COMBINATION WITH ANY REVERSE TRANSCRIPTASE INHIBITOR METHOD OF TREATMENT FOR CONTROLLING AND LOWERING INTRAOCULAR PRESSURE IN A HUMAN USE IN TREATING ALLERGIC REACTIONS PSORIASIS TREATING ANGINA PECTORIS AND HIGH BLOOD PRESSURE METHOD FOR THE DIAGNOSIS OF GASTROINTESTINAL DISORDERS BY UREA ISOTOAC OR NITROGEN LABELED CARBON TREATMENT OF METASTATIC BREAST CANCER IN POSTMENOPAUSAL WOMEN WITH ESTROGEN RECEPTOR POSITIVE TUMORS USE IN COMBINATION WITH CERTAIN LHRH ANALOGUES FOR THE TREATMENT OF ADVANCED PROSTATE CANCER TREATMENT METASTATIC CARCINOMA OF OVARY AFTER 1ST LINE FAILURE OR SUBSQUENT CHEMOTHERAPY, TREATMENT OF BREAST CANCER AFTER FAILURE OF COMBINATION CHEMOTHERAPY FOR METASTATIC DISEASE AND 2ND LINE TREATMENT OF AIDS RELATED KAPOSI'S SARCOMA METHOD OF TREATING INFECTIOUS UPPER GI TRACT DISORDERS CAUSED BY CAMPYLOBACTER PYLORIDIS INFECTION COMPRISING ADMINISTRATION OF A BISMUTH AGENT AND AN ANTIMICROBIAL AGENT METHOD OF TREATING GI DISORDERS COMPRISING ADMINISTRATION OF A BISMUTH-CONTAINING AGENT AND H2 RECEPTOR BLOCKING ANTI-SECRETORY AGENT METHOD OF TREATING GI DISORDERS COMPRISING ADMINISTRATION OF CAMPYLOBACTER-INHIBITING ANTIMICROBIAL AGENT AND H2 RECEPTOR BLOCKING ANTI-SECRETORY AGENT METHOD OF TREATING PEPTIC ULCER DISEASE CAUSED BY CAMPYLOBACTER PYLORIDIS COMPRISING ORAL ADMINISTRATION OF 50 TO 5,000MG BISMUTH DAILY FOR 3-56 DAYS TREATMENT OF ADVANCED BREAST CANCER IN POSTMENOPAUSAL WOMEN WITH DISEASE PROGRESSION FOLLOWING ANTIESTROGEN THERAPY USE OF TAXOL IN COMBINATION WITH G-CSF FOR TREATMENT OF PATIENTS WITH AIDS-RELATED KAPOSI'S SARCOMA METHOD FOR TREATING HEARTBURN METHOD OF USING FSH ALONE, WITHOUT THE PRESENCE OF EXOGENEOUS LH, IN IN VITRO FERTILIZATION USE AS NASAL SPRAY VAGINAL ADMINISTRATION USING SPECIFIED FORMULATION VAGINAL ADMINISTRATION OF PROGESTERONE USING SPECIFIED FORMULATION METHOD OF TREATING CONGESTIVE HEART FAILURE USE IN PATIENTS WITH REVERSIBLE AIRWAY OBSTRUCTION METHOD OF TREATMENT OF PARKINSON'S DISEASE METHOD OF INHIBITING CHOLESTEROL BIOSYNTHESIS AND TREATING HYPERCHOLESTEROLEMIA AND METHOD FOR TREATING HYPERLIPIDEMIA USE AS A BLOOD GLUCOSE-LOWERING AGENT TREATMENT OF EPILEPSY TWICE DAILY. TREATING A PATIENT BY ADMINISTERING CARBAMAZEPINE IN A DOSAGE FORM CAPABLE OF MAINTAINING BLOOD CONCENTRATION FROM 4-12MCG/ML OVER 12 HOURS TREATMENT OF ADENOCARCINOMA, INCLUDING STAGE B2-C BY ADMINISTERING AN AGONIST OF LH-RH AND FLUTAMIDE METHOD OF PRODUCING ANESTHESIA METHOD FOR LIMITING THE POTENTIAL FOR MICROBIAL GROWTH IN THE DRUG PRODUCT TREATMENT OF PARKINSON'S DISEASE METHOD OF DIAGNOSIS SELECTIVE VASODILATION BY CONTINUOUS ADENOSINE INFUSION METHOD OF TREATING PAGET'S DISEASE USING ACTONEL TREATMENT OF BACTERIAL CONJUNCTIVITIS CAUSED BY SUSCEPTIBLE STRAINS OF MICROORGANISMS CONTROLLING INTRAOCULAR PRESSURE MEHTOD FOR DELIVERY METHOD OF ENHANCING THE DISSOLUTION PROFILE OF A PHARMACEUTICAL FROM A SOLID DOSAGE FORM CONTAINING THE PHARMACEUTICAL AND SIMETHICONE NASAL ADMINISTRATION ASTHMA CARDIAC INSUFFICIENCY (CONGESTIVE HEART FAILURE) PREVENTION OF ACUTE CARDIAC ISCHEMIC EVENTS USE IN PARKINSON'S DISEASE

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

PATENT USE
U-232 U-233 U-234 U-235

ADB 28 of 51

U-236 U-237 U-238

U-239

U-240 U-241

U-242 U-243 U-244 U-245 U-246 U-247 U-248 U-249 U-250 U-251 U-252 U-253 U-254 U-255 U-256 U-257 U-258 U-259 U-260

U-261 U-262 U-263

U-264

U-265 U-266

U-267

U-268 U-269 U-270 U-271 U-272 U-273

METHOD OF TREATING MIGRAINE DECREASING MORTALITY CAUSED BY CONGESTIVE HEART FAILURE METHOD OF USING RIBAVIRIN TO TREAT VIRAL INFECTIONS IN MAMMALS METHOD OF MODULATING TH1 AND TH2 RESPONSE IN ACTIVATED T CELLS OF A HUMAN COMPRISING ADMINISTERING RIBAVIRIN TO THE T CELLS IN A DOSAGE WHICH PROMOTES THE TH1 RESPONSE AND SUPPRESSES THE TH2 RESPONSE TREATING MALE PATTERN BALDNESS WITH 0.05 TO 3.0MG/DAY METHOD OF PERFORMING NMR IMAGING WITH A PATIENT COMPRISING ADMINISTERING TO THE PATIENT AN EFFECTIVE AMOUNT OF CONTRAST AGENT DISCLOSED IN THE CLAIMS IMAGING A BODY TISSUE AND SUBJECTING TO NMR TOMOGRAPHY, ADMINISTERING AN AMOUNT OF PHARMACEUTICAL AGENT FOR AFFECTING THE RELAXATION TIMES OF ATOMS IN BODY TISSUES UNDERGOING NMR DIAGNOSIS, WHEREBY THE IMAGE CONTRAST IN ENHANCED.... TREATING OR CONTROLLING OCULAR INFLAMATION WHICH COMPRISES TOPICALLY ADMINISTERING TO AFFECTED EYE A COMPOSITION COMPRISING AN NSAID, A POLYMERIC QUATERNARY AMMONIUM COMPOUND AND BORIC ACID TREATMENT OF ACUTE MIGRAINE ATTACKS FOR SHORT-TERM TREATMENT ACTIVE DUODENAL ULCER, MAINTENANCE THERAPY FOR DUODENAL ULCER PATIENTS AT REDUCED DOSAGE AFTER HEALING OF ACTIVE ULCER, SHORT-TERM TREATMENT ACTIVE BENIGN GASTRIC ULCER & GERD, PATHOLOGICAL HYPERSECRETORY CONDITIONS USE OF FOLLITROPIN ALPHA ALONE IN IN-VITRO FERTILIZATION TOPICAL ADMINISTRATION PLATELET AGGREGATION INHIBITORS TREATMENT OF SEBORRHEA DERMATITIS IN HUMANS PHOSPHATE BINDING TREATMENT OF RHEUMATOID ARTHRITIS TREATMENT OF HIV METHOD OF TREATING ALLERGIC OR NON-ALLERGIC RHINITIS IN PATIENTS BY ADMINISTERING AEROSOLIZED PARTICLES OF MOMETASONE FUROATE TREATMENT OF HEPATITIS B INFECTION USE OF TROGLITAZONE IN COMBINATION WITH SULFONYLUREAS IN THE TREATMENT OF TYPE II DIABETES METHOD OF TREATING A HUMAN SUBJECT HAVING GAUCHER'S DISEASE ORAL TRANSMUCOSAL USE USE OF AGGRASTAT IN COMBINATION WITH HEPARIN IMPROVED WAKEFULNESS IN PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY TREATMENT OF HIV INFECTION IN COMBINATION WITH ONE OR MORE ADDITIONAL HIV ANTIVIRAL AGENTS TREATMENT OF HIV INFECTION TREATMENT OF NEURODEGENERATIVE DISEASES TREATMENT OF ANDROGENIC ALOPECIA BY ORAL ADMINISTRATION DRUG SUBSTANCE REDUCTION OF INTRAOCULAR PRESSURE IN PATIENTS WITH OPEN ANGLE GLAUCOMA AND OCULAR HYPERTENSION WHO ARE INTOLERANT OF OTHER IOP LOWERING MEDICATIONS OR INSUFFICIENTLY RESPONSIVE TO ANOTHER IOP LOWERING MEDICATION TREATING BENIGN PROSTATIC HYPERPLASIA WITH A GENUS OF COMPOUNDS, INCLUDING FINASTERIDE TREATING BENIGN PROSTATIC HYPERTROPHY WITH FINASTERIDE METHOD OF TREATING A MALIGNANT CONDITION THROUGH INTRAVASCULAR ADMINISTRATION OF BUSULFAN. METHOD FOR TREATING LEUKEMIA OR LYMPHOMA IN A PATIENT UNDERGOING A BONE MARROW TRANSPLANT THROUGH INTRAVENOUS ADMINISTRATION OF BUSULFAN METHOD OF TREATING A MALIGNANT DISEASE THROUGH PARENTERAL ADMINISTRATION OF BUSULFAN. METHOD FOR TREATING A PATIENT UNDERGOING A BONE MARROW TRANSPLANT THROUGH INTRAVASCULAR ADMINISTRATION OF BUSULFAN USE AS LAXATIVE RELIEF OF THE SIGNS AND SYMPTOMS OF OSTEOARTHRITIS; RELIEF OF THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS IN ADULTS; MANAGEMENT OF ACUTE PAIN IN ADULTS; TREATMENT OF PRIMARY DYSMENNORRHEA; ACUTE TREATMENT OF MIGRAINE ATTACKS IN ADULTS PREVENTING HEARTBURN EPISODES FOLLOWING INGESTION OF HEARTBURN-INDUCING FOOD/BEVERAGE, COMPRISING ADMIN TO PT, 30 MIN PRIOR TO CONSUMPTION BY THE PT THE FOOD/BEVERAGE, A COMPOSITION COMPRISING 10MG FAMOTIDINE ACROMEGALY EXCESS GH-SECRETION OR GASTRO-INTESTINAL DISORDERS METHOD OF IMPROVING THE TIME FOR ADMINISTRATION OR THE TIME BETWEEN CHANGES OF GIVING SETS FOR THE DRUG PRODUCT METHOD OF TREATING TUMORS METHOD OF TREATING CARCINOMA CUTANEOUS T-CELL LYMPHOMA

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

PATENT USE
U-274 U-275 U-276 U-277 U-278 U-279 U-280 U-281 U-282 U-283 U-284 U-285 U-286 U-287 U-288 U-289 U-290 U-291 U-292 U-293 U-294 U-295 U-296

ADB 29 of 51

U-297 U-298 U-299 U-300 U-301 U-302 U-303 U-304 U-305 U-306 U-307 U-308

U-309 U-310 U-311 U-312 U-313 U-314 U-315 U-316 U-317 U-318 U-319 U-320 U-321

ZANAMIVIR FOR INHALATION METHOD OF USE OF THE DRUG SUBSTANCE METHOD OF USE OF LEVOBUPIVACAINE NEUROLOGICAL AND OTHER DISORDERS (TREATMENT OF EPILEPSY, BID ORAL DOSING) METHOD OF USE OF THE INDICATION OF THE DRUG PRODUCT METHOD OF USE OF THE APPROVED PRODUCT TREATING PRECIPITATED ACUTE URINARY RETENTION WITH FINASTERIDE ANTIMYCOTIC USES, SPECIFICALLY TREATMENT OF ONYCHOMYCOSIS METHOD OF TREATING BACTERIAL INFECTIONS METHOD FOR TREATING MENOPAUSAL SYMPTOMS IN A POSTMENOPAUSAL FEMALE MENOPAUSAL AND POSTMENOPAUSAL DISORDERS (INCLUDING VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE, AND VULVAR AND VAGINAL ATROPHY) AND OSTEOPOROSIS DEPRESSION AND SOCIAL ANXIETY DISORDER/SOCIAL PHOBIA DEPRESSION TREATMENT OR PREVENTION OF OSTEOPOROSIS THERAPY OF INFLUENZA TREATMENT OF NON-HYPERKERATOTIC ACTINIC KERATOSES OF FACE AND SCALP INHIBITING TRANSPLANT REJECTION USING RAPAMYCIN (SIROLIMUS) INHIBITING TRANSPLANT REJECTION USING RAPAMYCIN (SIROLIMUS) IN COMBINATION WITH CYCLOSPORIN INHIBITING TRANSPLANT REJECTION USING RAPAMYCIN (SIROLIMUS) IN COMBINATION WITH AZATHIOPRINE INHIBITING TRANSPLANT REJECTION USING RAPAMYCIN (SIROLIMUS) IN COMBINATION WITH A CORTICOSTEROID TREATMENT OF HYPERPIGMENTARY DISORDERS TREATMENT OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS SYMPTOMS TREATING MIGRAINE PAIN AND ONE OR MORE OF A CLUSTER OF SYMPTOMS CHARACTERISTIC OF A MIGRAINE ATTACK SYMPTOMS BEING SELECTED FROM PHOTOPHOBIA, PHONOPHOBIA NAUSEA AND FUNCTIONAL DISABILITY PREVENTION OR TREATMENT OF REVERSIBLE VASOCONSTRICTION BY THE INHALATION OF NITRIC OXIDE WITH AN OXYGEN CONTAINING GAS METHOD OF COMBATING BACTERIA IN A PATIENT TREATMENT OF ADENOMATOUS POLYPS INDICATED FOR THE REDUCTION OF ELEVATED TOTAL AND LDL CHOLESTEROL LEVELS IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA USE OF TROGLITAZONE IN COMBINATION WITH SULFONYLUREAS AND BIGUANIDES IN THE TREATMENT OF TYPE II DIABETES TO REDUCE THE RISK OF STROKE IN PATIENTS WHO HAVE HAD TRANSIENT ISCHEMIA OF THE BRAIN OR COMPLETED ISCHEMIC STROKE DUE TO THROMBOSIS METHOD OF USE PATENT-PRODUCT APPROVED FOR TREATMENT OF OSTEOPOROSIS, PAGET'S DISEASE, PREVENTION AND TREATMENT OF GLUCOCORTICOID INDUCED OSTEOPOROSIS A METHOD OF TREATMENT OF A CONDITION INVOLVING AN ANTIBODY ANTIGEN REACTION METHODS FOR USING THE DRUG PRODUCT TREATMENT OF POST-MENOPAUSAL UROGENITAL SYMPTOMS ASSOCIATED WITH ESTROGEN DEFICIENCY CLAIMS AN OLANZAPINE POLYMORPH USEFUL FOR TREATING ANY NUMBER OF LISTED CONDITIONS, INCLUDING SPECIFIC PSYCHOSES,EMPLOYING OLANZAPINE AS PER THE INDICATION OF THIS NDA CLAIMS A SOLID ORAL FORMULATION INCLUDING TABLETS AND GRANULES OF OLANZAPINE USEFUL FOR TREATING ANY NUMBER OF LISTED CONDITIONS, INCLUDING SPECIFIC PSYCHOLES, EMPLOYING OLANZAPINE AS PER THE INDICATIONS OF THIS NDA TREATING SJOEGREN SYNDROME TREATMENT OF XEROSTOMIA HORMONE REPLACEMENT PANIC DISORDER, OBSESSIVE-COMPULSIVE DISORDER, POSTTRAUMATIC STRESS DISORDER TREATMENT OF CONGESTIVE HEART FAILURE METHOD FOR TREATING HYPERPARATHYROIDISM WHICH COMPRISES SUPPRESSING PARATHYROID ACTIVITY METHOD FOR ADMINISTERING DRUG TO GASTROINTESTINAL TRACT METHOD OF TREATING A SUBJECT SUFFERING FROM PROSTATE CANCER METHOD OF USING TROGLITAZONE TO TREAT PATIENTS HAVING INSULIN RESISTANCE TREATMENT OF PATIENTS WITH AN OVERACTIVE BLADDER WITH SYMPTOMS OF URINARY FREQUENCY, URGENCY, OR URGE INCONTINENCE TREATMENT OF MICROBIAL INFECTIONS INHIBITING OR ELIMINATING ACUTE MYELOID LEUKEMIA REDUCTION OF ELEVATED IPTH LEVELS IN THE MGT OF SECONDARY HYPERPARATHYROIDISM IN PATIENTS UNDERGONG CHRONIC RENAL DIALYSIS

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

PATENT USE
U-322 U-323 U-324 U-325 U-326 U-327 U-328 U-329 U-330 U-331 U-332 U-333 U-334 U-335 U-336 U-337 U-338 U-339 U-340 U-341 U-342 U-343 U-344 U-345 U-346

ADB 30 of 51

U-347 U-348 U-349 U-350 U-351 U-352 U-353 U-354

U-355 U-356 U-357

U-358 U-359 U-360

U-361 U-362 U-363

TREATMENT OF ALZHEIMER'S DEMENTIA USE AS A BILE ACID SEQUESTRANT METHOD OF TREATING AN ANIMAL, INCLUDING A HUMAN, SUFFERING FROM OR SUSCEPTIBLE TO PSYCHOSIS OR ACUTE MANIA EMPLOYING OLANZAPINE METHOD OF TREATING A PATIENT SUFFERING FROM ANY OF A NUMBER OF LISTED CONDITIONS, INCLUDING "BIPOLAR DISORDER NOS" EMPLOYING OLANZAPINE METHOD OF TREATING SCHIZOPHRENIA AND BIPOLAR DISORDER METHOD OF TREATING A PATIENT SUFFERING FROM ANY OF A NUMBER OF LISTED PSYCHOTIC CONDITONS EMPLOYING OLANZAPINE METHOD OF TREATING A PATIENT SUFFERING FROM ANY OF A NUMBER OF LISTED CONDITIONS INCLUDING "A PSYCHOTIC CONDITION" EMPLOYING AN OLANZAPINE POLYMORPH USE OF AVANDIA AS MONOTHERAPY, IN COMBINATION WITH METFORMIN, AND IN COMBINATION WITH SULFONYLUREAS TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2 DIABETES MELLITUS TREATMENT OF NAUSEA AND VOMITING METHOD OF TREATING HYPERLIPIDEMIA WITH NICOTINIC ACID BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT TREATMENT OR PREVENTION OF BRONCHOSPASM METHOD OF TREATING OCULAR HYPERTENSION TREATMENT OF EXCESSIVE FEMALE FACIAL HAIR USE OF PRAVASTATIN SODIUM FOR SECONDARY PREVENTION OF CORONARY EVENTS IN MEN AND WOMEN WHO HAVE HAD A MYOCARDIAL INFARCTION AND HAVE NORMAL CHOLESTEROL LEVELS DIAGNOSTIC RADIOIMAGING USE OF CARDIOLITE/MIRALUMA KIT FOR THE PREPARATION OF TC99M SESTAMIBI METHODS FOR TREATING DISTURBANCES OF MOOD, DISTURBANCES OF APPETITE, DEPRESSED MOOD, OR CARBOHYDRATE CRAVING ALL ASSOCIATED WITH PREMENSTRUAL SYNDROME PREVENTION OF CARDIO-TOXICITY CAUSED BY THE ADMINISTRATION OF DOXORUBICIN THE LONG TERM TREATMENT OF GROWTH FAILURE DUE TO LACK OF ADEQUATE ENDOGENOUS GROWTH HORMONE SECRETION IN CHILDREN METHOD FOR ENHANCING THE TREATMENT OF ... LATE LUTEAL PHASE DYSPHORIC DISORDER METHOD FOR TREATMENT OF LATE LUTEAL PHASE DYSPHORIC DISORDER REDUCTION OF INTESTINAL GAS, CRAMPING AND ANORECTAL IRRITATION METHOD FOR INHIBITING HIV INFECTION BY ADMINISTERING RITONAVIR IN COMBINATION WITH ANOTHER HIV PROTEASE INHIBITOR RITONAVIR AND ANOTHER HIV PROTEASE INHIBITOR FOR CONCOMITANT ADMINISTRATION FOR THE TREATMENT OF AN HIV INFECTION METHOD FOR INHIBITING CYTOCHROME P450 MONOOXYGENASE WITH RITONAVIR AND A METHOD FOR IMPROVING THE PHARMCOKINETICS OF A DRUG THAT IS MTABOLIZED BY CYTOCHROME P450 MONOOXYGENASE BY ADMIN THE DRUG AND RITONAVIR METHOD OF USE IN COMBINATION WITH REVERSE TRANSCRIPTASE INHIBITORS METHOD OF USE FOR INHIBITING HIV INFECTION METHOD OF USE WHICH IS SUBJECT OF THE APPLICATION PREPARATION OF A PHARMACEUTICAL COMPOSITION FOR CONCOMITANT ADMIN WITH A REVERSE TRANSCRIPTASE INHIBITOR INHIBITING PROTEASE WITH LOPINAVIR AND INHIBITING AN HIV INFECTION WITH LOPINAVIIR INHIBITING HIV INFECTION BY ADMINISTERING RITONAVIR IN COMBINATION WITH A REVERSE TRANSCRIPTASE INHIBITOR PREVENTION AND TREATMENT OF OSTEOPOROSIS METHOD OF TREATING HYPERLIPIDEMIA WITH NICOTINIC ACID WITHOUT CAUSING TREATMENT-LIMITING ELEVATIONS IN URIC ACID OR GLUCOSE LEVELS OR CAUSING LIVER DAMAGE, BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT METHOD OF ASSISTING PERSON TO QUIT SMOKING...TRANSDERMALLY ADMIN NICOTINE VIA..PATCH ADHERED TO SKIN AT DOSING RATE APPROX SAME AS ABSORBED FROM SMOKING DELIVERING A MEDICINAL AEROSOL FORMULATION USING CFC-FREE PROPELLANT 134A. USE OF THE DRUG PRODUCT IN PHOTODYNAMIC THERAPEUTIC PROTOCOLS FOR THE TREATMENT OF AGERELATED MACULAR DEGENERATION AND RELATED CONDITIONS INVOLVING UNWANTED NEOVASCULATURE IN THE EYE DEPRESSION, OBSESSIVE COMPULSIVE DISORDER, PANIC DISORDER AND SOCIAL ANXIETY DISORDER METHOD OF USE OF VISICOL METHOD OF TREATING A PATIENT SUFFERING FROM ANY OF A NUMBER OF PATHOLOGICAL PSYCHOLOGICAL CONDITIONS INCLUDING MENTAL DISORDERS EMPLOYING OLANZAPINE AS PER THE INDICATION WHICH IS THE SUBJECT MATTER OF THIS SNDA-011 MANAGEMENT OF ANXIETY DISORDERS AND THE SHORT-TERM RELIEF OF THE SYMPTOMS OF ANXIETY USE OF APPROVED FORMULATIONS TO TREAT ALL APPROVED DISEASE INDICATIONS METHOD OF TREATING A PATIENT SUFFERING FROM ANY OF A NUMBER OF PATHOLOGICAL PSYCHOLOGICAL CONDITIONS THAT RELATE TO THE USE OF A PSYCHOACTIVE SUBSTANCE EMPLOYING OLANZAPINE AS PER THE INDICATION THE SUBJECT MATTER OF SUPPLEMENT 011

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

PATENT USE
U-364

ADB 31 of 51

U-365 U-366 U-367 U-368 U-369 U-370 U-371 U-372 U-373

U-374

U-375 U-376 U-377

U-378 U-379 U-380 U-381 U-382 U-383 U-384 U-385 U-386 U-387 U-388 U-389 U-390 U-391 U-392 U-393 U-394 U-395 U-396 U-397 U-398 U-399 U-400

U-401 U-402 U-403 U-404 U-405 U-406 U-407

TREATING A PATIENT SUFFERING FROM OR SUSCEPTIBLE TO ANY NUMBER OF LISTED CONDITIONS INCLUDING PSYCHOSIS, EMPLOYING OLANZAPINE AS PER THE INDICATION WHICH IS THE SUBJECT MATTER OF THIS SNDA-011 METHOD FOR THE TREATMENT OF CARDIOVASCULAR DISEASE THROUGH THE ADMINISTRATION OF A CALCIUM BLOCKING VASODILATOR IN OUR EXTENDED, CONTROLLED RELEASE FORMULATION METHOD FOR THE TREATMENT OF CARDIOVASCULAR DISEASE THROUGH THE ADMINISTRATION OF A CALCIUM BLOCKING VASODILATOR IN A DELAYED RELEASE FORMULATION TREATMENT OF CARDIOVASCULAR DISORDERS HEARTBURN METHOD OF CONTROLLING AND LOWERING INTRAOCULAR PRESSURE INTRAVAGINAL TREATMENT OF VAGINAL INFECTIONS WITH BUFFERED METRONIDAZOLE COMPOSITIONS APPROVAL FOR MARKETING ONLY UNDER A SPECIAL RESTRICTION PROGRAM APPROVED BY FDA CALLED "SYSTEM FOR THALIDOMIDE EDUCATION AND PRESCRIBING SAFETY" (S.T.E.P.S.) METHOD FOR ADMINISTERING A BENEFICIAL DRUG TO THE GI TRACT OF AN ANIMAL, WHICH METHOD COMPRISES ADMITTING AN OSMOTIC DEVICE ORALLY INTO THE ANIMAL... GENERAL USE CLAIM SUBMITTED FOR 12 NEXIUM PATIENTS STATING "PERTINENT TO THE CAPSULE FORMULATION FOR NEXIUM AND ITS INDICATIONS FOR THE TREATMENT OF GERD AND ERADICATION OF H.PYLORI TO REDUCE THE RISK OF DUODENAL ULCER RECURRENCE KIT ADAPTED AND DESIGNED TO PROVIDE BOTH DATA ON THE CURRENT REPRODUCTIVE STATUS OF A PATIENT AND CONTRACEPTION FOR THOSE WHO ARE NOT PREGNANT, BUT RECENTLY ENGAGED IN UNPROTECTED SEX METHOD OF USING RIBAVIRIN FOR TREATING A DISEASE RESPONSIVE TO RIBAVIRIN, E.G. HEPATITIS C TREATMENT OF INFLUENZA METHOD OF TREATING PT WITH CHRONIC HEPATITIS C HAVING HCV GENOTYPE 1 AND VIRAL LOAD GREATER THAN 2 MILLION COPIES/ML TO ERADICATE DETECTABLE HCV-RNA BY ADMIN COMBINATION OF RIBAVIRIN AND INTERFERON ALFA-2B FOR A LEAST 24 WEEKS METHOD FOR TREATING INCONTINENCE METHOD OF TREATING ONYCHROMYCOSIS COMBINATIONS OF TAXOL (PACLITAXEL) AND CISPLATIN WHICH ARE SUITABLE FOR THE TREATMENT OF OVARIAN AND NON-SMALL CELL LUNG CARCINOMAS TREATMENT OF HYPERPHOSPHATEMIA METHOD OF STABLIZING PROSTAGLANDIN METHOD FOR TREATING GLAUCOMA AND OCULAR HYPERTENSION TREATMENT OF CMV RETINITIS TREATMENT OF PEPTIC ULCERS TREATMENT OF PATIENTS SUFFERING FROM A LATE ASTHMATIC REACTION OR LATE PHASE ASTHMA TREATMENT OF PATIENTS WITH RESPIRATORY DISORDERS SMOKING CESSATION AID APPLIED TO THE SKIN SMOKING CESSATION AID APPLIED TO THE SKIN ON WAKING AND REMOVED PRIOR TO SLEEP AFTER ABOUT 16 HOURS METHOD OF USING THE DRUG TO TREAT NEUROIMMUNOLOGIC DISEASES (INCLUDING MULTIPLE SCLEROSIS) USE OF CASODEX IN COMBINATION WITH LHRH AGONISTS FOR THE TREATMENT OF PROSTATE CANCER TREATMENT OF PATIENTS FOR INFLAMMATION MANAGEMENT OF INCONTINENCE, MGT OF HORMONE REPLACEMENT THERAPY, TREATMENT OF INVOLUNTARY INCONTINENCE, MGT OVERACTIVE BLADDER AND INCREASING COMPLIANCE IN SUCH PT METHOD OF USE OF ALPHAGAN METHOD OF USE OF ALPHAGAN P METHOD OF TREATING PEOPLE SUFFERING FROM DEPRESSION METHOD OF TREATING PEOPLE SUFFERING FROM DEPRESSION WITHOUT AN INCREASE IN NAUSEA TREATMENT OF GENERALIZED ANXIETY DISORDER IN-THE-EYE USE OF CHLORINE DIOXIDE CONTAINING COMPOSITIONS USE OF RIBAVIRIN TO INCREASE TYPE 1 CYTOKINE RESPONSE AND SUPPRESS TYPE 2 CYTOKINE RESP0NSE TO LYMPHOCYTES, INCLUDING METHODS THAT TAKE ADVANTAGE OF SUCH MODULATION TO TREAT INFECTIONS AND INFESTATIONS USE OF LOPINAVIR IN COMBINATION WITH REVERSE TRANSCRIPTASE INHIBITORS FOR TREATING HIV INFECTION AND IN COMBO WITH OTHER HIV PROTEASE INHIBITORS TREATMENT OF ACTINIC KERATOSES ANTI-ALLERGIC FOR VARIOUS ALLERGIC DISEASES TREATMENT OF ALLERGIC CONJUNCTIVITIS FOR WOMEN WITH SEVERE DIARRHEA-PREDOMINANT IRRITABLE BOWEL SYNDROME (IBS) METHOD OF USE OF ATOVAQUONE AND PROGUANIL METHOD OF TREATING OTOPATHY

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

PATENT USE
U-408 U-409 U-410

ADB 32 of 51

U-411

U-412 U-413 U-414 U-415

U-416

U-417 U-418

U-419 U-420 U-421 U-422 U-423 U-424 U-425

U-426 U-427 U-428 U-429 U-430

U-431 U-432

U-433 U-434 U-435 U-436 U-437 U-438 U-439 U-440 U-441 U-442 U-443 U-444 U-445 U-446

FOR INDUCING OVULATION IN CONJUNCTION WITH A GONADOTROPIN RELEASING FACTOR ANTAGONIST AND RECRUITING OOCYTES FOR IN-VITRO FERTILIZATION METHOD OF TREATING INFLAMMATION USING DRUG SUBSTANCE METHOD OF REDUCING AMOUNT OF RESPECTIVE ACTIVE COMPONENTS ADMINISTERED TO A DIABETIC PATIENT BY ADMINISTERING A CHEMICAL COMPOUND HAVING A PARTICULAR FORMULA (INCLUDING PIOGLITAZONE) IN COMBINATION WITH AN INSULIN SECRETION ENHANCER METHOD OF REDUCING THE SIDE EFFECTS OF ACTIVE COMPONENTS ADMINISTERED TO A DIABETIC PATIENT BY ADMINISTERING A CHEMICAL COMPOUND HAVING A PARTICULAR FORMULA (WHICH INCLUDES PIOGLITAZONE) IN COMBINATION WITH AN INSULIN PREPARATION TREATMENT OF TYPE 2 DIABETES USE OF THE ACTIVE INGREDIENT FOR INHIBITING THE BIOSYNTHESIS OF CHOLESTEROL AND TREATMENT OF ATHEROSCLEROSIS A METHOD OF TREATING GLYCOMETABOLISM DISORDERS BY ADMINISTERING AN INSULIN SENSITIVITY ENHANCER (INCLUDING PIOGLITAZONE) IN COMBINATION WITH A BIGUANIDE A METHOD FOR REDUCING THE AMOUNT OF ACTIVE COMPONENTS ADMINISTERED TO A DIABETIC PATIENT BY ADMINISTERING AN INSULIN SENSITIVITY ENHANCER (INCLUDING PIOGLITAZONE) IN COMBINATION WITH A BIGUANIDE AS SAID ACTIVE COMPONENTS A METHOD FOR REDUCING SIDE EFFECTS OF ACTIVE COMPONENTS ADMINISTERED TO A DIABETIC PATIENT BY ADMINISTERING AN INSULIN SENSITIVITY ENHANCER (INCLUDING PIOGLITAZONE) IN COMBINATION WITH A BIGUANIDE AS SAID ACTIVE COMPONENTS COMBINATION USE OF AD-4833 WITH A BIGUANIDE A METHOD OF TREATING LIPID METABOLISM DISORDERS BY ADMINISTERING A CHEMICAL COMPOUND HAVING A PARTICULAR FORMULA (WHICH INCLUDES PIOGLITAZONE) IN COMBINATION WITH AN INSULIN SECRETION ENHANCER A METHOD OF TREATING LIPID METABOLISM DISORDERS BY ADMINISTERING AN INSULIN SENSITIVITY ENHANCER (INCLUDING PIOGLITAZONE) IN COMBINATION WITH A BIGUANIDE METHOD OF TREATMENT OF TYPE II DIABETES USE FOR SEDATION METHOD OF TREATING AT LEAST ONE OF ATTENTION DEFICIT DISORDER AND ATTENTION DEFICIT HYPERACTIVITY DISORDER METHOD OF TREATING AT LEAST ONE OF ATTENTION DEFICIT DISORDER, ATTENTION DEFICIT HYPERACTIVITY DISORDER, OR AIDS RELATED DEMENTIA FOR ONCE DAILY, BOLUS ADMINISTRATION TO A PATIENT IN ORDER TO ENGENDER TREATMENT FOR A NERVOUS DISORDER FOR SUBSTANTIALLY AN ENTIRE DAY ON A CHRONIC BASIS METHOD OF REDUCING SIDE EFFECTS OF ACTIVE COMPONENTS ADMIN TO A DIABETIC BY ADMIN A CHEMICAL COMPOUND HAVING FORMULA (INCL PIOGLITAZONE) IN COMBINATION WITH AN INSULIN SECRETION ENHANCER PREVENTION OF PREMATURE LH SURGES IN WOMEN UNDERGOING CONTROLLED OVARIAN STIMULATION METHOD OF TREATING ALLERGIC REACTIONS IN MAMMALS METHOD OF TREATING ALLERGY IN A MAMMAL USING THIS ACTIVE METABOLITE METHOD OF USING DESLORATADINE TO TREAT ALLERGIC RHINITIS METHOD OF TREATING A DIABETIC BY ADMINISTERING AN INSULIN SENSITIZER IN COMBINATION WITH AN INSULIN SECRETION ENHANCER, AND A DRUG PRODUCT C0MPRISING AN INSULIN SENSITIZER AND AN INSULIN SECRETION ENHANCER POSTTRAUMATIC STRESS DISORDER REDUCTION OF ATHEROSCLEROTIC EVENTS (MYOCARDIAL INFARCTION, STROKE, AND VASCULAR DEATH) IN PATIENTS WITH ATHEROSCLEROSIS DOCUMENTED BY RECENT STROKE, RECENT MYOCARDIAL INFARCTION OR ESTABLISHED PERIPHERAL ARTERIAL DISEASE USE OF LEVOCARITINE IN PREVENTION AND TREATMENT OF CARNITINE DEFICIENCY IN PATIENTS WITH END STAGE RENAL DISEASE WHO ARE UNDERGOING DIALYSIS CONTROLLED SYMPTOMS OF DIARRHEA, BLOATING PRESSURE AND CRAMPS, COMMONLY REFERRED TO AS GAS A TITRATION DOSING REGIMEN FOR THE TREATMENT OF PAIN USING AN INITIAL DOSE OF ABOUT 25MG ACUTE TREATMENT OF MIGRAINE ATTACKS WITH OR WITHOUT AURA IN ADULTS METHOD OF USE EQUAL TO PROCESS OF PREPARATION TREATMENT/PREVENTION OF NEURODEGENERATIVE DISEASE TREATMENT OF OBESITY METHOD FOR TRANSDERMAL ADMINISTRATION OF A DRUG THROUGH NON-SCROTAL SKIN USING A TRANSDERMAL DRUG DELIVERY DEVICE CONTAINING THE DRUG AND HAVING AN ADHESIVE SURFACE METHOD OF TREATING MS BY ADMINISTERING COPAXONE METHOD FOR DELIVERING A DRUG TO A PATIENT IN NEED OF THE DRUG, WHILE AVOIDING THE OCCURENCE OF AN ADVERSE SIDE EFFECT KNOWN OR SUSPECTED OF BEING CAUSED BY SAID DRUG MANAGEMENT OF MODERATE TO SEVERE PAIN WHEN A CONTINUOUS, AROUND-THE-CLOCK ANALGESIC IS NEEDED FOR AN EXTENDED PERIOD OF TIME TREATMENT OF MIGRAINE USE AS AN ANTIMYCOTIC AGENT TOPICAL TREATMENT OF OCULAR HYPERTENSION AND GLAUCOMA

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

PATENT USE
U-447 U-448

ADB 33 of 51

U-449 U-450

U-451 U-452 U-453 U-454

U-455 U-456 U-457 U-458 U-459 U-460 U-461 U-462 U-463 U-464 U-465 U-466 U-467 U-468 U-469 U-470 U-471 U-472 U-473 U-474

U-475 U-476

U-477

U-478

U-479 U-480 U-481 U-482 U-483 U-484 U-485

METHOD OF TREATING HYPERLIPIDEMIA WITH NICOTINIC ACID BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT METHOD OF TREATING HYPERLIPIDEMIA WITH NICOTINIC ACID WITHOUT CAUSING TREATMENT-LIMITING ELEVATIONS IN URIC ACID OR GLUCOSE LEVELS OR CAUSING LIVER DAMAGE, BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT USE IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN FOR THE TREATMENT OF METASTATIC COLORECTAL CANCER WHERE THE DOSE OF LEUCOVORIN IS AT LEAST 200MG PER SQUARE METER INTERMEDIATE REL NICOTINIC ACID FORMULATIONS HAVING UNIQUE URINARY METAB PROFILES RESULTING FROM ABSORPTION PROFILES OF NICOTINIC ACID FROM THE INTERMEDIATE NICOTINIC ACID FORMULATIONS,SUITABLE FOR TX HYPERLIPIDEMIA FOLLOWING QD DOSING TREATMENT OF DEPRESSION AND GENERALIZED ANXIETY DISORDER USE OF LANSOPRAZOLE FOR COMBATTING DISEASES CAUSED BY THE GENUS CAMPYLOBACTER (C.PYLORI=H.PYLORI) TREATMENT OF PLATELET ASSOCIATED ISCHEMIC DISORDERS METHOD OF TX A PT SUSPECTED OF HAVING HEPATITIS C BY ADMIN, IN COMBINATION, A CONJUGATE COMPRISING PEG 12000 & INTERFERON ALFA-2B IN AN AMT OF FROM 0.5MCG/KG TO 2MCG/KG, ONCE WEEKLY, AND RIBAVIRIN TREATMENT OF PULMONARY HYPERTENSION WITH UT-15 METHOD OF DECREASING THE PRODUCTION OF A-BETA USING A COMPOSITION WHICH DECREASES BLOOD CHOLESTEROL IN PATIENTS AT RISK OF OR EXHIBITING SYMPTOMS OF ALZHEIMER'S DISEASE METHOD OF TREATING A VAGINAL FUNGAL INFECTION IN A FEMALE HUMAN METHOD OF USE OF IMAGENT TREATMENT OF DEPRESSION AND GENERALIZED ANXIETY DISORDER METHOD OF TREATING PSYCHIATRIC SYMPTOMS ASSOCIATED WITH PREMENSTRUAL DISORDERS USING SERTRALINE METHOD OF TREATMENT OF LATE LUTEAL PHASE DYSPHORIC DISORDER (PMDD) USING SERTRALINE SIGNS AND SYMPTOMS OF OSTEOARTHRITIS AND ADULT RHEUMATOID ARTHRITIS AND TREATMENT OF PRIMARY DYSMENORRHEA VENOGRAPHY PERIPHERAL ARTERIOGRAPHY CT IMAGING OF THE HEAD TREATMENT OF IRRITABLE BOWEL SYNDROME USE OF EPLERENONE IN COMBINATION WITH AN ANGIOTENSIN CONVERTING ENZYME (ACE) INHIBITOR FOR TREATING HYPERTENSION METHOD OF USING FEXOFENADINE HCL IN TREATING ALLERGIC RHINITIS TREATMENT OF GASTROESOPHAGEAL REFLEX DISEASE (GERD) AND ERADICATION OF H.PYLORI TO REDUCE RISK OF DUODENAL ULCER RECURRENCE THERAPY IN CHRONIC HEPATITIS B VIRUS INFECTION METHOD OF TREATING A PATIENT SUFFERING FROM DIABETES MELLITUS TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER USING METHYLPHENIDATE BI-MODAL RELEASE PROFILE EXTENDED-RELEASE CAPSULES TO REDUCE PLASMA CHOLESTEROL LEVELS IN A MAMMAL TO REDUCE PLASMA CHOLESTEROL LEVELS BY ADMIN EZETIMIBE IN COMBO WITH CHOLESTEROL BIOSYNTHESIS INHIB SELECTED FROM GROUP CONSISTING OF HMG COA REDUCTASE INHIBITORS INCL SIMVASTATIN TREATMENT OF CUTANEOUS MANIFESTATIONS OF CUTANEOUS T-CELL LYMPHOMA IN PATIENTS WHO ARE REFRACTORY TO AT LEAST ONE PRIOR SYSTEMIC THERAPY METHOD OF TREATING ANDROGEN RESPONSIVE/MEDIATED CONDITION IN MAMMAL BY ADMIN A SAFE, EFFECTIVE AMOUNT OF DUTASTERIDE OR PHARMACEUTICALLY ACCEPTABLE DERIVATIVE THEREOF..CONDITIONS INCLUDE BENIGN PROSTATIC HYPERTROPHY METHOD OF INHIBITING 5 ALPHA TESTOSTERONE REDUCTASE ENZYME WITH DUTASTERIDE OR ITS DERIVATIVE AND TREATING ANDROGEN RESPONSIVE/MEDIATED DISEASE INCLUDING BENIGN PROSTATIC HYPERPLASIA METHOD OF TREATING HEPATITIS C VIRAL INFECTION BY CONTINUOUS PARENTERAL ADMIN INTERFERON ALPHA 2-10 MILLION IU WEEKLY, SUBCUTANEOUSLY, INJECTION OF POLYMER-INTERFERON ALPHA CONJUGATE-POLYMER IS PEG-INTERFERON IS ALPHA 2B METHOD OF USING PEG-INTRON/REBETOL COMBINATION THERAPY AND INTRON/REBETOL COMBINATION THERAPY CONTRAST AGENT FOR MRI DISUBSTITUTED ACETYLENES BEARING HETEROAROMATIC AND HETEROBICYCLIC GROUPS HAVING RETINOID-LIKE ACTIVITY METHOD OF IN VITRO FERTILIZATION THERAPY INCLUDING MEANS FOR INDUCING OVULATION.... METHOD FOR THE ADMINISTRATION OF DRUGS USING THAT COMPOUND METHOD OF TREATING A SKIN DISEASE WITH A CORTICOSTEROID-CONTAINING PHARMACEUTICAL COMPOSITION METHOD AND COMPOSITION FOR REDUCING NERVE INJURY PAIN ASSOCIATED WITH SHINGLES (HERPES ZOSTER AND POST-HERPETIC NEURALGIA)

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

PATENT USE
U-486 U-487 U-488 U-489 U-490 U-491 U-492

ADB 34 of 51

U-493 U-494 U-495 U-496 U-497 U-498 U-499

U-500 U-501 U-502 U-503 U-504 U-505 U-506

U-507 U-508 U-509 U-510

U-511 U-512 U-513 U-514 U-515 U-516 U-517 U-518 U-519 U-520 U-521 U-522 U-523 U-524 U-525 U-526 U-527 U-528 U-529 U-530

EXTERNAL PREPARATION FOR APPLICATION TO THE SKIN CONTAINING LIDOCAINE-DRUG RETAINING LAYER PLACED ON SUPPORT AND COMPRISES ADHESIVE GEL BASE 1-10% BY WEIGHT OF LIDOCAINE METHOD AND COMPOSITION FOR REDUCING NERVE INJURY PAIN ASSOCIATED WITH SHINGLES (HERPES ZOSTER AND POST-HERPETIC NEURALGIA) METHOD FOR REDUCING THE PAIN ASSOCIATED WITH HERPES-ZOSTER AND POST-HERPETIC NEURALGIA EXPECTORANT TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE METHOD OF DELIVERING A DRUG TO THE LUNG METHOD FOR THE TREATMENT OF SKIN, SUFFERING FROM A CONDITION SELECTED FROM A GROUP CONSISTING OF NONACNE INFLAMMATORY DERMATOSES... COMPRISING APPLYING TO AFFECTED AREA. A THERAPEUTICALLY EFFECTIVE AMT AZELAIC ACID TREATMENT OF TYPE 2 DIABETES MELLITUS TREATMENT OF ATTENTION-DEFICIT HYPERACTIVITY DISORDER PERITONEAL DIALYSIS SOLUTION METHOD FOR TREATING CHRONIC RENAL FAILURE RELIEF OF THE SIGNS AND SYMPTOMS OF OSTEOARTHRITIS AND RHEUMATOID ARTHRITIS INTRA-ARTERIAL AND INTRAVENOUS USES OF ULTRAVIST METHOD OF USING REBETOL CAPSULES IN COMBINATION WITH A CONJUGATE COMPRISING POLYETHYLENE GLYCOL(PEG) AND AN ALPHA INTERFERON, INCLUDING, FOR EXAMPLE, PEG-INTRON POWDER FOR INJECTION USE AS AN ANTIHYPERTENSIVE AGENT TREATMENT OF RECURRENT HERPES LABIALIS (COLD SORES) IN ADULTS PITYRIASIS VERSICOLOR GENERATOR MUST BE USED WITH INFUSION SYSTEM SPECIFICALLY LABELED FOR USE WITH GENERATOR TINEA PEDIS, TINEA CRURIS, TINEA CORPORIS ULTRASOUND CONTRAST AGENT PHARM PRODUCT CONTAINER 1ST CHAMBER IS DISPOSED AQUEOUS DILUENT SOL 2ND CHAMBER PHARM ACTIVE AGENT COMPRISING ACETYLCHOLINE,BUFFER IN 1ST CHAM IS SUFFICIENT TO BUFFER PH OF MIXED SOL RESULTING MIXTURE OF AQUEOUS DILUENT SOL & PHARM ACTIVE.. ACROMEGALY IN PATIENTS W/INADEQUATE RESPONSE TO SURGERY AND/OR RADIATION THERAPY AND/OR MEDICAL THERAPIES, OR FOR WHOM THESE THERAPIES ARE NOT APPROPRIATE METHOD OF RELEASING 17-BETA OESTRADIOL PRECURSOR IN A SUBSTANTIALLY ZERO ORDER PATTERN FOR AT LEAST THREE WEEKS TREATMENT OF CUTANEOUS MANIFESTATIONS OF CUTANEOUS T-CELL LYMPHOMA IN PATIENTS WHO ARE REFRACTORY TO AT LEAST ONE PRIOR SYSTEMIC THERAPY TOPICAL TREATMENT OF CUTANEOUS LESIONS IN PATIENTS WITH CUTANEOUS T-CELL LYMPHOMA (STAGE IA AND IB) WHO HAVE REFRACTORY OR PERSISTENT DISEASE AFTER OTHER THERAPIES OR WHO HAVE NOT TOLERATED OTHER THERAPIES USE OF QUINOLONE COMPOUNDS AGAINST ANAEROBIC PATHOGENIC BACTERIA USE OF QUINOLONE COMPOUNDS AGAINST ATYPICAL UPPER RESPIRATORY PATHOGENIC BACTERIA METHODS OF USE OF ANTIMICROBIAL COMPOUNDS AGAINST PATHOGENIC AMYCOPLASMA BACTERIA PREVENTION OF OVULATION IN A WOMAN TREATMENT OF MULTIPLE MYELOMA PATIENTS WHO HAVE RECEIVED AT LEAST TWO PRIOR THERAPIES AND HAVE DEMONSTRATED DISEASE PROGRESSION ON THE LAST THERAPY METHOD OF TREATING A PSYCHOTIC DISEASE STABLE GEL FORMULATION FOR TOPICAL TREATMENT OF SKIN CONDITIONS OBSESSIVE COMPULSIVE DISORDER POST OPERATIVE NAUSEA AND VOMITING PREMENOPAUSAL OSTEOPOROSIS METHOD OF USING RIBAVIRIN IN COMBINATION WITH INTRON A (INTERFERON ALPHA-2 B RECOMBINANT) INJECTION TO TREAT PATIENTS WITH CHRONIC HEPATITIS C TREATMENT OF CMV RETINITIS BY INTRAVITREAL ADMIN OF A PHOSPHOROTHIOATE OLIGONUCLEOTIDE CAPABLE OF HYBRIDIZING WITH CMV MRNA METHOD OF TREATING INFECTION BY CRYPTOSPORIDIUM PARVUM IN AN IMMUNOCOMPROMISED MAMMAL METHOD OF TREATING DIARRHEA METHOD OF TREATING PARASITIC INFECTIONS METHOD OF PROVIDING CONTROLLED RELEASE OF A TREATING AGENT USING A CONTROLLED RELEASE COMPOSITION METHOD OF DELIVERING AN ACTIVE INGREDIENT USING A PROGRESSIVE HYDRATION BIOADHESIVE PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING ONCE DAILY TREATMENT OF ASTHMA WITH NEBULIZED BUDESONIDE TREATMENT OF HERPES ZOSTER, TREATMENT OF GENITAL HERPES, TREATMENT OF COLD SORES, SUPPRESSION OF GENITAL HERPES IN IMMUNOCOPETENT AND HIV-INFECTED INDIVIDUALS, REDUCTION OF RISK OF HETEROSEXUAL TRANSMISSION OF GENITAL HERPES

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

PATENT USE
U-531 U-532 U-533 U-534 U-535 U-536 U-537 U-538

ADB 35 of 51

U-539 U-540 U-541 U-542 U-543 U-544 U-545

U-546 U-547 U-548 U-549 U-550 U-551 U-552 U-553

U-554 U-555 U-556 U-557 U-558 U-559

U-560 U-561

U-562 U-563 U-564 U-565 U-566 U-567 U-568 U-569 U-570 U-571 U-572 U-573

TREATMENT OF PATIENTS WITH ESSENTIAL HYPERTENSION. MAY BE USED ALONE OR GIVEN WITH OTHER CLASSES OF ANTIHYPERTENSIVES, ESPECIALLY THIAZIDE DERIVATIVES TREATMENT OF BRONCHOSPASM ASSOCIATED WITH COPD IN PATIENTS REQUIRING MORE THAN ONE BRONCHO DILATOR ERECTILE DYSFUNCTION HUMALOG IS AN INSULIN ANALOG THAT IS INDICATED IN THE TREATMENT OF PATIENTS WITH DIABETES MELLITUS FOR THE CONTROL OF HYPERGLYCEMIA TREATMENT OF SOCIAL ANXIETY DISORDER CONTRAST AGENT FOR MAGNETIC RESONACE IMAGING TREATMENT OF CONDITIONS RELATED TO HYPERALDOSTERONISM SUCH AS HYPERTENSION AND CARDIAC INSUFFICIENCY, WITH EPLERENONE FIRST LINE TREATMENT OF SEVERE HYPERTENSION, IN PATIENTS WITH HYPERTENSION SEVERE ENOUGH THAT THE VALUE OF ACHIEVING PROMPT BLOOD PRESSURE CONTROL EXCEEDS THE RISK OF INITIATING COMBINATION THERAPY IN THESE PATIENTS TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE TREATMENT OF FUNGAL INFECTIONS METHOD OF TREATMENT OF ADULTS INFECTED WITH HIV-1 METHOD OF TREATING PATIENT WITH TYPE 2 DIABETES BY ONCE DAILY ADMINISTRATION TREATMENT OF SCHIZOPHRENIA TREATMENT OF OVERACTIVE BLADDER. TREATMENT OF URINARY INCONTINENCE. METHOD FOR THE PREVENTION AND/OR TREATMENT OF THROMBOTIC EPISODES, SUCH AS MYOCARDIAL INFARCTION, IN A HUMAN PATIENT AND METHOD FOR THE PREVENTION OF VENOUS THROMBOSIS IN A POSTOPERATIVE HUMAN PATIENT USE OF REPAGLINIDE IN COMBINATION WITH METFORMIN TO LOWER BLOOD GLUCOSE MAINTENANCE MONOTHERAPY FOR BIPOLAR DISORDER A METHOD OF REDUCING FLUSH IN AN INDIVIDUAL BEING TREATED FOR A LIPIDEMIC DISORDER AND EFFECTIVELY TREATING THE LIPIDEMIC DISORDER USE IN THE TREATMENT OF MEN WITH ADVANCED SYMPTOMATIC PROSTATE CANCER TREATMENT OF BIPOLAR DISORDER AND SCHIZOPHRENIA METHOD FOR REDUCING TOXICITY OF ALIMTA TREATED PATIENTS BY ADMINISTERING FOLIC ACID TREATMENT OF HYPERTENSION AND HYPERLIPIDEMIA WITH A SINGLE COMPOSITION MANAGEMENT OF PAIN AND DISCOMFORT ASSOCIATED WITH PERIDONTAL SCALING AND ROOT PLANNING PROCEDURES BY APPLICATION OF AN EUTECTIC MIXTURE OF LOCAL ANESTHETICS TO PERIDONTAL POCKETS TREATING HIV INFECTION WITH INDINAVIR SULFATE IN COMBINATION WITH ANTIRETROVIRAL AGENTS TREATMENT OF COMPLICATED URINARY TRACT INFECTIONS AND ACUTE UNCOMPLICATED PYELONEPHRITIS USE AS ADJUNCT DIAGNOSTIC FOR SERUM THYROGLOBULIN (TG) TESTING NASAL TREATMENT OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS SYMPTOMS INDICATED FOR THE RELIEF OF BRONCHOSPASM IN PATIENTS 2-12 YEARS OF AGE WITH ASTHMA (REVERSIBLE OBSTRUCTIVE AIRWAY DISEASE) METHOD OF DECREASING OR REDUCING PARATHYROID HORMONE LEVEL; METHOD OF MODULATING PARATHYROID HORMONE SECRETION;METHOD OF TREATING HYPERPARATHYROIDISM; METHOD OF REDUCING SERUM IONIZED CALCIUM LEVEL METHOD OF DECREASING PARATHYROID HORMONE LEVEL;METHOD OF TREATING HYPERPARATHYROIDISM COSOPT IS INDICATED FOR THE REDUCTION OF ELEVATED INTRAOCULAR PRESSURE IN PATIENTS WITH OPEN-ANGLE GLAUCOMA OR OCULAR HYPERTENSION WHO ARE INSUFFICIENTLY RESPONSIVE TO BETA BLOCKERS TOPICAL TREATMENT OF CUTANEOUS LESIONS IN PATIENTS WITH AIDS-RELATED KAPOSI'S SARCOMA MARINOL IS INDICATED FOR, INTER ALIA, ANOREXIA ASSOCIATED WITH WEIGHT LOSS IN PATIENTS WITH AIDS TREATMENT OF HIV IN CONCOMITANT THERAPY TREATMENT OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS SYMPTOMS, AND CHRONIC URTICARIA FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF BRONCHOSPASM ASSOCIATED WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND EMPHYSEMA METHOD OF TREATING INFERTILITY METHOD OF USING FSH ALONE (WITHOUT EXOGENOUS LH) IN IN VITRO FERTILIZATION METHOD OF USING FSH ALONE (WITHOUT EXOGENOUS LH) IN IN VITRO FERTILIZATION AND WHEREIN THEREAFTER AN OVULATORY INDUCING AMOUNT OF HCG IS ADMINISTERED METHOD OF USING FSH ALONE (WITHOUT EXOGENOUS LH) IN IN VITRO FERTILIZATION AND WHEREIN THE DAILY AMOUNT OF FSH IS ABOUT 5-10 IU/KG TREATMENT OF AGITATION ASSOCIATED WITH SCHIZOPHRENIA AND BIPOLAR I MANIA INTENSIVE CARE UNIT SEDATION TREATMENT OF ACUTE PROMYELOGENOUS LEUKEMIA (APL)

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

PATENT USE
U-574

ADB 36 of 51

U-575 U-576 U-577 U-578

U-579 U-580 U-581 U-582

U-583

U-584 U-585 U-586

U-587 U-588

U-589

U-590

U-591 U-592 U-593 U-594 U-595 U-596 U-597 U-598 U-599 U-600 U-601 U-602

U-603 U-604 U-605

U-606

PROPHYLAXIS AND TREATMENT OF THE NASAL SYMPTOMS OF SEASONAL ALLERGIC RHINITIS AND TREATMENT OF THE NASAL SYMPTOMS OF PERENNIAL ALLERGIC RHINITIS IN ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER LOTEMAX OPTHALMIC SUSPENSION IS INDICATED FOR THE TREATMENT OF STEROID RESPONSIVE CONDITIONS OF THE PALPEBRAL BULBAR CONJUNCTIVA, CORNEA AND ANTERIOR SEGMENT OF THE GLOBE. ALREX OPTHALMIC SUSPENSION IS INDICATED FOR THE TEMPORARY RELIEF OF THE SIGNS AND SYMPTOMS OF SEASONAL ALLERGIC CONJUNCTIVITIS. TREATMENT OF BENIGN PROSTATIC HYPERPLASIA WITH FINASTERIDE IN COMBINATION WITH DOXAZOSIN TREATMENT OF COMMUNITY ACQUIRED PNEUMONIA, ACUTE EXACERBATION OF CHRONIC BRONCHITIS, AND ACUTE BACTERIAL SINUSITIS CAUSED BY SUSCEPTIBLE STRAINS OF DESIGNATED MICROORGANISMS IN PATIENTS 18 YEARS AND OLDER. TREATMENT OF EPILEPSY AND/OR MIGRAINE. TREATMENT OF DISORDERS OF THE SEROTONERGIC SYSTEM SUCH AS DEPRESSION AND ANXIETY-RELATED DISORDERS METHOD OF TREATING A CONDITION CAPABLE OF TREATMENT BY INHALATION, E.G. ASTHMA, COMPRISING ADMINISTRATION OF A FORMULATION CLAIMED IN US PATENT NO. 6743413 METHOD FOR THE TREATMENT OF A RESPIRATORY DISORDER, E.G. ASTHMA, COMPRISING ADMINISTERING AN EFFECTIVE AMOUNT OF AN AEROSOL COMPOSITION TO A PATIENT FROM A METERED DOSE INHALER SYSTEM AS CLAIMED IN US PATENT NO. 6253762 METHOD FOR THE TREATMENT OF A RESPIRATORY DISORDER, E.G. ASTHMA, COMPRISING ADMINISTERING TO A PATIENT BY INHALATION, A METERED AEROSOL DOSE OF A DRUG FORMULATION FROM THE METERED DOSE INHALER SYSTEM CLAIMED IN US 6546928 SINGLE-DOSE ADMINISTRATION BY THE EPIDURAL ROUTE, AT THE LUMBAR LEVEL, FOR THE TREATMENT OF PAIN FOLLOWING MAJOR SURGERY TO PROMOTE WEIGHT GAIN AFTER WEIGHT LOSS IN CERTAIN TYPES OF PATIENTS AN INTERMEDIATE RELEASE NICOTINIC ACID FORMULATION SUITABLE FOR ORAL ADMINISTRATION ONCEA-DAY AS A SINGLE DOSE FOR TREATING HYPERLIPIDEMIA WITHOUT CAUSING DRUG-INDUCED HEPATOTOXICITY OR ELEVATIONS IN URIC ACID OR GLUCOSE OR BOTH USE OF EPLERENONE IN COMBINATION WITH AN ANGIOTENSIN CONVERTING ENZYME (ACE) INHIBITOR (AND OPTIONALLY A DIURETIC) FOR TREATING CONGESTIVE HEART FAILURE AND HYPERTENSION SHORT-TERM TREATMENT OF ACTIVE DUODENAL ULCER; TREATMENT OF HEARTBURN AND OTHER SYMPTOMS ASSOCIATED WITH GERD; SHORT-TERM TREATMENT OF EROSIVE ESOPHAGITIS; MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS METHOD FOR TREATMENT OF A RESPIRATORY DISORDER, E.G., BRONCHOSPASM, COMPRISING ADMINISTERING AN EFFECTIVE AMOUNT OF AN AEROSOL COMPOSITION TO A PATIENT FROM A METERED DOSE INHALER SYSTEM AS CLAIMED IN U.S. PATENT NO. 6131966 METHOD FOR TREATMENT OF A RESPIRATORY DISORDER,E.G.,BRONCHOSPASM,COMPRISING ADMINISTERING TO A PATIENT BY ORAL OR NASAL INHALATION A DRUG FORMULATION BY USING THE METERED DOSE INHALER SYSTEM AS CLAIMED IN US PATENT NO.6532955 TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER USING A DOSAGE FORM WHICH PROVIDES ONCE-DAILY ORAL ADMINISTRATION OF A PHENIDATE DRUG TREATMENT OF PRIMARY HYPERCHOLESTEROLEMIA, MIXED HYPERLIPIDEMIA AND/OR HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HOFH) TREATMENT OF PRIMARY HYPERCHOLESTEROLEMIA, MIXED HYPERLIPIDEMIA AND/OR HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HOFH) PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS 35 MG ORALLY ONCE A WEEK FOR PREVENTION OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN; 35 MG ORALLY ONCE A WEEK FOR TREATMENT OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN TREATMENT OF HORMONE RECEPTOR POSITIVE METASTATIC BREAST CANCER IN POSTMENOPAUSAL WOMEN WITH DISEASE PROGRESSION FOLLOWING ANTIESTROGEN THERAPY FORTEO IS INDICATED FOR THE TREATMENT OF POST MENOPAUSAL WOMEN WITH OSTEOPOROSIS WHO ARE AT HIGH RISK FOR FRACTURE PROPHYLACTIC TREATMENT OF MIGRAINE METHOD FOR TREATING ALLERGIC CONJUNCTIVITIS A METHOD OF TREATING A PATIENT IN NEED OF OPHTHALMIC ANTIMICROBIAL THERAPY WITH LEVOFLOXACIN TREATMENT OF BIPOLAR DISORDER SIGNS AND SYMPTOMS OF OSTEOARTHRITIS, RHEUMATOID ARTHRITIS IN ADULTS, AND/OR PAUCIARTICULAR OR POLYARTICULAR COURSE JUVENILE RHEUMATOID ARTHRITIS, ACUTE PAIN IN ADULTS; PRIMARY DYSMENORRHEA; AND/OR ACUTE MIGRAINE ATTACKS IN ADULTS METHOD OF TREATING INFECTIONS COMPRISING ORALLY ADMINISTERING AN EFFECTIVE AMOUNT OF THE FDA APPROVED ORAL SUSPENSION METHOD OF LOWERING BLOOD GLUCOSE BY ONCE DAILY ADMINISTRATION TREATMENT OF MAJOR DEPRESSIVE DISORDER(MDD);ALTHOUGH THE MEHCHANISM OF THE ANTIDEPRESSANT ACTION OF DULOXETINE IN HUMANS IS UNKNOWN, IT IS BELIEVED TO BE RELATED TO ITS POTENTIATION OF SERATONERGIC AND NORADRENERGIC ACTIVITY IN THE CNS USE OF IRINOTECAN IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN FOR THE TREATMENT OF METASTATIC COLRECTAL CANCER

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

PATENT USE
U-607 U-608 U-609 U-610

ADB 37 of 51

U-611 U-612 U-613 U-614 U-615

U-616

U-617 U-618

U-619 U-620 U-621 U-622 U-623 U-624 U-625 U-626 U-627 U-628 U-629 U-630 U-631 U-632 U-633

U-634

U-635 U-636 U-637 U-638 U-639 U-640 U-641 U-642 U-643

U-644 U-645 U-646 U-647

CANCIDAS IS INDICATED FOR EMPIRICAL THERAPY FOR PRESUMED FUNGAL INFECTIONS IN FEBRILE, NEUTROPENIC PATIENTS. USE OF QUINOLONE COMPOUNDS AGAINST PNEUMOCOCCAL PATHOGENIC BACTERIA USE OF QUINOLONE COMPOUNDS AGAINST QUINOLONE-RESISTANT PNEUMOCOCCAL PATHOGENIC BACTERIA ATROVENT HFA (IPRATROPIUM BROMIDE HFA) INHALATION AEROSOL IS INDICATED AS A BRONCHODILATOR FOR MAINTENANCE TREATMENT OF BRONCHOSPASM ASSOCIATED WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE, INCLUDING CHRONIC BRONCHITIS AND EMPHYSEMA. METHOD OF USING DESLORATADINE TO TREAT SEASONAL AND PERENNIAL ALLERGIC RHINITIS, PRURITIS, AND CHRONIC IDIOPATHIC URTICARIA IN PATIENTS 2 YEARS OF AGE AND OLDER TREATMENT OF SEASONAL ALLERGY SYMPTOMS WITH NASAL CONGESTION IN ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER REDUCTION OF SERUM PHOSPHATE TREATMENT OF SEXUAL DYSFUNCTION ADJUNCTIVE THERAPY TO DIET IN ADULTS TO REDUCE LDL-C, TOTAL-C, TRIGLYCERIDES AND APO B, AND INCREASE HDL-C IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA OR MIXED DYSLIPIDEMIA (TYPES IIA, IIB) AND TO TREAT HYPERTRIGLYCERIDEMIA (TYPES IV, V) MANAGEMENT OF PERSISTENT, MODERATE TO SEVERE PAIN IN PATIENTS REQUIRING CONTINUOUS, AROUND-THE-CLOCK ANALGESIA WITH A HIGH POTENCY OPIOID FOR AN EXTENDED PERIOD OF TIME GENERALLY WEEKS TO MONTHS OR LONGER TREATMENT OF ACUTE PROMYELOGENOUS LEUKEMIA (APL) USE OF ROSUVASTATIN CALCIUM TO REDUCE ELEVATED TOTAL-C, LDL-C, APOB, NONHDL-C OR TG LEVELS; TO INCREASE HDL-C IN ADULT PATIENTS WITH PRIMARY HYPERLIPIDEMIA OR MIXED DYSLIPIDEMIA; AND TO SLOW THE PROGRESSION OF ATHEROSCLEROSIS. TREATMENT OF MALIGNANT NEOPLASM TREATMENT OF INSOMNIA METHOD OF TREATING CANCER TREATMENT OF VEGF MEDIATED OCULAR DISEASE. SHORT TERM TREATMENT OF ACTIVE BENIGN GASTRIC ULCER REDUCTION OF RISK OF UPPER GASTROINTESTINAL BLEEDING IN CRITICALLY ILL PATIENTS ALLERGIC RHINITIS OR NASAL POLYPS CLOLAR IS INDICATED FOR THE TREATMENT OF PEDIATRIC PATIENTS 1 TO 21 YEARS OLD WITH RELAPSED OR REFRACTORY ACUTE LYMPHOBLASTIC LEUKEMIA AFTER AT LEAST TWO PRIOR REGIMENS TREATMENT OF PATIENTS USING EXTENDED-RELEASE CARBAMAZEPINE USE OF AVANDIA IN COMBINATION WITH A SULFONYLUREA, AND IN COMBINATION WITH METFORMIN AND A SULFONYLUREA TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2 DIABETES MELLITUS METHOD OF INDUCING A HYPNOTIC OR SEDATIVE EFFECT IN A HUMAN BY ADMINISTERING ESZOPICLONE TREATING URINARY INCONTINENCE BY ADMINISTERING AN EXTENDED-RELEASE FORM OF DARIFENACIN TREATING A DISEASE OF ALTERED MOTILITY OR TONE OF SMOOTH MUSCLE BY ADMINISTERING A MUSCARINIC RECEPTOR ANTAGONIZING AMOUNT OF DARIFENACIN METHOD OF TREATMENT OF CANCER BY ADMINISTERING PARTICLES OF PACLITAXEL THAT HAVE A PROTEIN COATING METHOD FOR TREATMENT OF TUMORS BY ADMINISTERING PACLITAXEL AT A DOSE IN THE RANGE OF ABOUT 30MG/METER SQUARE TO ABOUT 100MG/METER SQUARE IN A PHARMACEUTICALLY ACCEPTABLE FORMULATION THAT DOES NOT CONTAIN CREMOPHOR METHOD FOR DELIVERY OF A BIOLOGIC (INCLUDING ANTINEOPLASTIC AGENTS) BY ADMINISTERING TO A PATIENT AN EFFECTIVE AMOUNT OF A BIOLOGIC AS A SOLID OR LIQUID WITH A POLYMERIC BIOCOMPATIBLE MATERIAL TREATMENT OF GERD, MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS AND RISK REDUCTION OF NSAID ASSOCIATED GASTRIC ULCERS TREATMENT OR PREVENTION OF BRONCHOSPASM OR ASTHMATIC SYMPTOMS TREATMENT OF DIABETES WITH AN AMYLIN AGONIST TREATMENT OF DIABETES WITH AN AMYLIN AGONIST, INCLUDING WITH INSULIN TREATMENT OF A MAMMAL HAVING A NEED OF OR REDUCED ABILITY TO PRODUCE INSULIN WITH AN INSULIN AND AN AMYLIN SUCH AS PRAMLINTIDE USE OF AN AMYLIN AGONIST TO REDUCE GASTRIC MOTILITY AND TREAT POST PRANDIAL HYPERGYLCEMIA USE OF AN AMYLIN AGONIST HAVING SPECIFIED BINDING ACTIVITY TO REDUCE GASTRIC MOTILITY, INCLUDING USE THROUGH PARENTERAL ADMINISTRATION TREATMENT AND PREVENTION OF OSTEOPOROSIS THE SHORT TERM TREATMENT (UP TO 10 DAYS) IN PTS HAVING GASTROESOPHAGEAL REFLUX DISEASE (GERD) AS AN ALTERNATIVE TO ORAL THERAPY IN PTS WHEN THERAPY WITH NEXIUM CAPSULES IS NOT POSSIBLE OR APPROPRIATE TREATMENT OF SEASONAL ALLERGIC RHINITIS TREATMENT OF ASTHMA METHOD OF TREATING OTITIS TREATMENT OF OSTEOPOROSIS IN POST MENOPAUSAL WOMEN AND/OR THE TREATMENT TO INCREASE BONE MASS IN MEN WITH OSTEOPOROSIS

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

PATENT USE
U-648 U-649 U-650 U-651 U-652 U-653 U-654 U-655

ADB 38 of 51

U-656 U-657 U-658 U-659 U-660 U-661 U-662 U-663 U-664 U-665 U-666 U-667 U-668 U-669 U-670 U-671 U-672 U-673 U-674 U-675 U-676 U-677 U-678 U-679 U-680

U-681 U-682 U-683 U-684 U-685 U-686 U-687 U-688 U-689 U-690

THE TREATMENT OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN AND/OR THE TREATMENT TO INCREASE BONE MASS IN MEN A METHOD FOR TREATING A TUMOR DISEASE TREATMENT OF ESOPHAGEAL CANDIDIASIS AND PROPHYLAXIS OF CANDIDA INFECTIONS IN HSCT PATIENTS TREATMENT OF ACUTE PROMYELOCYTIC LEUKEMIA (APL) TREATMENT OF CARDIAC ARRHYTHMIA STIMULATING INSULIN RELEASE BY ADMINISTERING EXENATIDE LOWERING PLASMA GLUCAGON IN A SUBJECT IN NEED THEREOF, INCLUDING ONE WITH TYPE 2 DIABETES, BY ADMINISTERING AN EXEDIN OR ANALOG, SUCH AS EXENDIN-4 TREATMENT OF MILD TO MODERATE ACTIVE CHROHN'S DISEASE INVOLVING THE ILEUM AND/OR THE ASCENDING COLON AND THE MAINTENANCE OF CLINICAL REMISSION OF MILD TO MODERATE CROHN'S DISEASE INVOLVING THE ILEUM AND/OR ASCENDING COLON FOR UP TO 3 MONTHS REDUCING GASTRIC MOTILITY OR DELAYING GASTRIC EMPTYING BY ADMINISTERING AN EXENDIN, SUCH AS EXENDIN-4 PREVENTION OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN TREATMENT OF ADVANCED HORMONE-DEPENDENT BREAST CANCER TREATMENT OF LOCALLY ADVANCED OR METASTATIC NON SMALL-CELL LUNG CANCER (NSCLC) AFTER FAILURE OF AT LEAST ONE PRIOR CHEMOTHERAPY REGIMEN TREATMENT OF HYPERTENSION AND TREATMENT OF HEART FAILURE TREATMENT OF SEIZURE DISORDER TREATMENT OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN THE TREATMENT OF UNCOMPLICATED URINARY TRACT INFECTIONS TREATMENT OF CONDITIONS FOR WHICH AN ALDOSTERONE RECEPTOR BLOCKER IS INDICATED, SUCH AS HYPERTENSION, HEART FAILURE, AND POST-MYOCARDIAL INFARCTION METHOD OF USING THE DRUG SUBSTANCE/DRUG PRODUCT FOR ULTRASOUND IMAGING METHOD OF TREATING ADHD MANAGEMENT OF INCONTINENCE; METHOD FOR TREATING INCONTINENCE LEVEMIR IS A LONG-ACTING BASAL INSULIN ANALOG THAT IS INDICATED IN THE TREATMENT OF PATIENTS WITH DIABETES MELLITUS INDICATION OF TYPE II DIABETES TREATMENT OF HIV-1 INFECTION BY THE CO-ADMINISTRATION OF TIPRANAVIR AND RITONAVIR. PREVENTION AND TREATMENT OF SECONDARY HYPERPARATHYROIDISM ASSOCIATED WITH CHRONIC KIDNEY DISEASE (CKD) STAGE 3 AND 4 TREATMENT OF INFLAMMATION OR AN INFLAMMATION-ASSOCIATED DISORDER METHOD OF TREATMENT WITH ONCE-DAILY DOSES OF 625MG/5ML METHOD OF TREATING INSOMNIA CHARACHTERIZED BY DIFFICULTY WITH SLEEP ONSET PROPHYLAXIS AND CHRONIC TREATMENT OF ASTHMA; RELIEF OF SYMPTOMS OF ALLERGIC RHINITIS METHOD OF TREATING ATTENTION DEFICIT DISORDER USING ORAL ADMINISTRATION OF A BI-MODAL OR PULSATILE RELEASE COMPOSITION A METHOD OF TREATING DISEASE AMENABLE TO TREATMENT WITH A PHENIDATE DRUG BY ONCE DAILY ORAL ADMINISTRATION OF AN EXTENDED RELEASE DOSAGE FORM METHOD OF TREATING ATTENTION DEFICIT DISORDER AND/OR ATTENTION DEFICIT HYPERACTIVITY DISORDER ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2 DIABETES WHO ARE ALREADY TREATED WITH A PIOGLITAZONE AND METFORMIN A METHOD OF TREATING DYSLIPIDEMIA AND DYSLIPOPROTEINEMIA USING A DOSAGE FORM THAT CAN PROVIDE AN EFFECTIVE AMOUNT OF FENOFIBRATE TO A PATIENT IN A FASTED STATE WHICH IS AT LEAST 90% OF THE AUC AMOUNT PROVIDED BY THE DOSAGE FORM TREATMENT OF PRIMARY IGF-1 DEFICIENCY NON-BENZODIAZEPINE HYPNOTIC AGENT INDICATED FOR TREATMENT OF INSOMNIA, CHARACTERIZED BY DIFFICULTIES WITH SLEEP ONSET AND/OR SLEEP MAINTENANCE PREVENTION OR TREATMENT OF ISCHEMIC HEART DISEASE TREATMENT OF UNCOMPLICATED SKIN MANIFESTATIONS OF CHRONIC IDIOPATHIC URTICARIA IN ADULTS AND CHILDREN 6 YEARS OF AGE AND OLDER EXPECTORANT AND COUGH SUPPRESSANT EXPECTORANT AND NASAL DECONGESTANT REDUCING FOOD INTAKE IN A SUBJECT WITH TYPE 2 DIABETES BY ADMINISTERING AN EXENDIN, SUCH AS EXENDIN-4 TREATMENT OF HIV-INFECTION IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS TREATMENT OF PATIENTS WITH T-CELL ACUTE LYMPHOBLASTIC LEUKEMIA WHOSE DISEASE HAS NOT RESPONDED TO OR HAS RELAPSED FOLLOWING TREATMENT WITH AT LEAST TWO CHEMOTHERAPY REGIMENS TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2 DIABETES MELLITUS

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

PATENT USE
U-691

ADB 39 of 51

U-692 U-693

U-694

U-695

U-696 U-697 U-698 U-699 U-700 U-701 U-702 U-703 U-704 U-705 U-706 U-707 U-708 U-709 U-710

U-711 U-712 U-713 U-714 U-715 U-716

U-717 U-718 U-719 U-720 U-721 U-722 U-723 U-724 U-725 U-726 U-727 U-728 U-729 U-730 U-731 U-732

USE AS A MONOTHERAPY, IN COMBINATION WITH A SULFONYLUREA, METFORMIN OR INSULIN OR IN COMBINATION WITH A SULFONYLUREA PLUS METFORMIN TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2 DIABETES MELLITUS USE OF VALSARTAN TO REDUCE CARDIOVASCULAR MORTALITY IN CLINICALLY STABLE PATIENTS WITH LEFT VENTRICULAR FAILURE OR LEFT VENTRICULAR DYSFUNCTION FOLLOWING MYOCARDIAL INFARCTION THE RECOMMENDED INITIAL DOSE OF EQUETRO IS 400MG/DAY GIVEN IN DIVIDED DOSES, TWICE DAILY. THE DOSE SHOULD BE ADJUSTED IN 200MG DAILY INCREMENTS TO ACHIEVE OPTIMAL CLINICAL RESPONSE. LENALIDOMIDE IS AN ANALOGUE OF THALIDOMIDE. THALIDOMIDE IS A KNOWN HUMAN TERATOGEN THAT CAUSES SEVERE LIFE-THREATENING HUMAN BIRTH DEFECTS. IF LENALIDOMIDE IS TAKEN DURING PREGNANCY, IT MAY CAUSE BIRTH DEFECTS OR DEATH TO AN UNBORN BABY. TREATMENT OF PATIENTS WITH T-CELL ACUTE LYMPHOBLASTIC LEUKEMIA AND T-CELL LYMPHOBLASTIC LYMPHOMA WHOSE DISEASE HAS NOT RESPONDED TO OR HAS RELAPSED FOLLOWING TREATMENT WITH AT LEAST TWO CHEMOTHERAPY REGIMENS TREATMENT OF PATIENTS WITH T-CELL LYMPHOBLASTIC LYMPHOMA WHOSE DISEASE HAS NOT RESPONDED TO OR HAS RELAPSED FOLLOWING TREATMENT WITH AT LEAST TWO CHEMOTHERAPY REGIMENS A METHOD OF USING RINFABATE RECOMBINANT (RHIGFBP-3) WITH MECASERMIN RECOMBINANT (RHIGF1) TO PROMOTE LINEAR GROWTH IN THE TRATMENT OF PRIMARY IGF-1 DEFICIENCY METHOD OF USING ANTAGONIST OF ARGININE VASOPRESSIN (AVA) V1A AND V2 RECEPTORS FOR INTRAVENOUS TREATMENT OF PATEINTS WITH EUVOLEMIC HYPONATREMIA NASAL TREATMENT OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS SYMPTOMS TREATMENT AND PREVENTION OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN TREATMENT OF HYPERCHOLESTEROLEMIA AND/OR HYPERTRIGLYCERIDEMIA TOPICAL AEROSOL HAIR REGROWTH TREATMENT TREATMENT OF PROTEIN KINASE RELATED DISORDERS, SUCH AS GASTROINTESTINAL STROMAL TUMOR AND RENAL CELL CARCINOMA WITH SUNITINIB METHOD OF ADMINISTERING INSULIN VIA INHALATION TREATING CHRONIC ANGINA BY ADMINISTERING AN EXTENDED RELEASE FORM OF RANOLAZINE TREATMENT OF BENIGN PROSTATIC HYPERPLASIA ALLERGIC RHINITIS TREATMENT OF CHRONIC NON-INFECTIOUS UVEITIS AFFECTING THE POSTERIOR SEGMENT OF THE EYE METHOD OF COMBATING BACTERIA IN A PATIENT A METHOD OF TREATING RESPIRATORY DISORDERS, E.G., ASTHMA, WHICH COMPRISES ADMINISTRATION BY INHALATION OF AN EFFECTIVE AMOUNT OF A PHARMACEUTICAL FORMULATION AS CLAIMED IN US PATENT NO. 5658549 ACUTE AND LONGER-TERM TREATMENT OF MAJOR DEPRESSIVE DISORDER A METHOD OF USING A NICOTINIC ACID FORMULATION TO REDUCE ELEVATED TC, LDL-C AND TG LEVELS, AND RAISE HDL-C LEVELS IN PATIENTS WITH HYPERLIPIDEMIA TREATMENT OF MILD TO MODERATE DEMENTIA OF THE ALZHEIMER'S TYPE TOPICAL TREATMENT OF INTERDIGITAL TINEA PEDIS AND TINEA CORPORIS DUE TO TRICHOPHYTON RUBRUM, TRICHOPHYTON MENTAGROPHYTES OR EPIDERMOPHYTON FLOCCOSUM FOR CLEANSING THE BOWEL IN PREPARATION FOR COLONOSCOPY, IN ADULTS 18 YEARS OF AGE OR OLDER THE TREATMENT OR PREVENTION OF BRONCHOSPASM IN ADULTS AND CHILDREN 4 YEARS OF AGE AND OLDER WITH REVERSIBLE OBSTRUCTIVE AIRWAYS DISEASE AND THE PREVENTION OF EXERCISEDINDUCED BRONCHOSPASM IN PATIENTS 4 YEARS OF AGE AND OLDER METHOD OF RELIEVING OR PREVENTING CONSTIPATION IN A HUMAN CONSTIPATED PATIENT TREATMENT OF FUNGAL INFECTIONS TREATENT OF PSYCHOSIS TREATMENT OF NEUROLEPTIC DISEASES TREATMENT OF INFLUENZA PROPHYLAXIS OF INFLUENZA PROPHYLACTIC TREATMENT OF MIGRAINE METHOD OF TREATING SEIZURES ALLERGIC RHINITIS AND URTICARIA ALLERGIC RHINITIS FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) METHOD FOR TREATING BACTERIAL INFECTION TREATMENT OF GASTROESOPHAGEAL REFLUX DISEASE (GERD), RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER, H. PYLORI ERADICATION TO REDUCE THE RISK OF DUODENAL ULCER RECURRENCE USE AS A NASAL SPRAY FOR TREATMENT OF THE SYMPTOMS OF SEASONAL ALLERGIC RHINITIS AND VASOMOTOR RHINITIS USE IN COMBINATION WITH DEXAMETHASONE IS INDICATED FOR THE TREATMENT OF PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA ACUTE TREATMENT OF THE CUTANEOUS MANIFESTATIONS OF MODERATE TO SEVERE ERYTHEMA NODOSUM LEPROSUM (ENL)

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

PATENT USE
U-733 U-734 U-735 U-736 U-737 U-738 U-739 U-740 U-741 U-742 U-743 U-744 U-745 U-746 U-747 U-748 U-749 U-750 U-751 U-752 U-753 U-754 U-755 U-756 U-757 U-758 U-759 U-760 U-761 U-762 U-763 U-764 U-765 U-766 U-767 U-768

ADB 40 of 51

U-769 U-770 U-771 U-772

U-773 U-774 U-775 U-776

U-777 U-778 U-779 U-780

MAINTENANCE THERAPY FOR PREVENTION AND SUPRESSION OF THE CUTANEOUS MANIFESTATIONS OF ENL RECURRENCE FIRST LINE THERAPY FOR TYPE 2 DIABETES MELLITUS METHOD OF TREATING CHRONIC IRON OVERLOAD METHOD FOR IONTOPHORETIC TRANSDERMAL DELIVERY OF FENTANYL HYDROCHLORIDE DISINFECTION OF PATIENT SKIN PRIOR TO AN INVASIVE PROCEDURE INDICATED FOR THE LONG-TERM, TWICE-DAILY MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS 12 YEARS OF AGE OR OLDER METHOD FOR TREATING CONSTIPATION BY OPENING CIC CHANNELS IN A MAMALIAN SUBJECT FOR THE TREATMENT OF PATIENTS WITH PRIMARY BILIARY CIRRHOSIS COMBINATION THERAPY WITH CISPLATIN FOR THE TREATMENT OF LATE STAGE CERVICAL CANCER TWICE DAILY TOPICAL TREATMENT OF MODERATE TO SEVERE PLAQUE PSORIASIS. ONCE A DAY TOPICAL TREATMENT OF THE INFLAMMATORY LESIONS OF ROSACEA TREATMENT OF HIV INFECTION IN ANTIRETROVIRAL TREATMENT-EXPERIENCED ADULT PATIENTS TREATMENT OR PREVENTION OF EMESIS PREVENTION OR TREATMENT OF NAUSEA OR EMESIS INDUCED BY A CANCER CHEMOTHERAPEUTIC AGENT PREVENTION OR TREATMENT OF POST-OPERATIVE NAUSEA AND VOMITING A METHOD FOR THE TREATMENT OF A PROTEIN TYROSINE KINASE-ASSOCIATED DISORDER METHOD OF CONTRACEPTION TREATMENT OF HIV-1 INFECTION IN ADULTS ONCE DAILY DOSING OF BUDESONIDE VIA NEBULIZER FOR THE TREATMENT OF ASTHMA SUNSCREEN AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2 DIABETES USE FOR THE LONG-TERM MAINTENANCE TREATMENT OF ASTHMA TREATMENT OF ANOREXIA, CACHEXIA, OR AN UNEXPLAINED, SIGNIFICANT WEIGHT LOSS IN PATIENTS WITH A DIAGNOSIS OF ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS) ADDITION OF ONCE-WEEKLY DOSING FOR THE TREATMENT TO INCREASE BONE MASS IN MEN WITH OSTEOPOROSIS USE AS A BILE ACID SEQUESTRANT FOR LOWERING CHOLESTEROL TREATMENT OF SYMPTOMS OF PREMENSTRUAL DYSPHORIC DISORDER METHOD OF USE OF ADMINISTERING LEVOTHYROXINE PROPHYLAXIS OF INVASIVE ASPERGILLUS AND CANDIDA INFECTIONS AND TREATMENT OF OROPHARYNGEAL CANDIDAIASIS TREATMENT OF SCHIZOPHRENIA INCLUDING MAINTAINING STABILITY IN PATIENTS WITH SCHIZOPHRENIA TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE ADMINISTRATION OF ARIPIPRAZOLE BY INJECTION TREATMENT OF SCHIZOPHRENIA METHOD OF TREATING ALLERGIC CONJUNCTIVITIS TREATMENT OF SEIZURES MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER A METHOD OF REDUCING THE CAPACITY OF EXTENDED RELEASE NICOTINIC ACID TO PROVOKE A FLUSHING REACTION BY PRETREATING AN INDIVIDUAL WITH A FLUSH INHIBITING AGENT PRIOR TO THE ADMINISTRATION OF THE EXTENDED RELEASE NICOTINIC ACID REVLIMID (LENALIDOMIDE) IN COMBINATION WITH DEXAMETHASONE IS INDICATED FOR THE TREATMENT OF MULTIPLE MYELOMA PATIENTS WHO HAVE RECEIVED AT LEASET ONE PRIOR THERAPY LONG-TERM TREATMENT OF PATHOLOGICAL HYPERSECRETORY CONDITIONS METHOD FOR THE TREATMENT OF DIABETES MELLITUS, SUCH AS TYPE 1 DIABETES MELLITUS OR TYPE 2 DIABETES MELITUS, IN A HUMAN PATIENT RELIEF OF SYMPTOMS ASSOCIATED WITH SEASONAL ALLERGIC RHINITIS IN CHILDREN 2 TO 11 YEARS AND FOR THE RELIEF OF SYMPTOMS ASSOCIATED WITH UNCOMPLICATED SKIN MANIFESTATIONS OF CHRONIC IDIOPATHIC URTICARIA IN CHILDREN 6 MONTHS TO 11 YEARS PATHOLOGICAL HYPERSECRETORY CONDITIONS METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASTE-IV INHIBITOR METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR IN COMBINATION WITH METFORMIN AND/OR A SULFONYLUREA TREATMENT OF CUTANEOUS MANIFESTATION IN PATIENTS WITH CUTANEOUS T-CELL LYMPHOMA (CTCL) WHO HAVE PROGRESSIVE, PERSISTENT OR RECURRENT DISEASE ON OR FOLLOWING TWO SYSTEMIC THERAPIES. DECREASING MORTALITY CAUSED BY CONGESTIVE HEART FAILURE REDUCTION OF ELEVATED INTRAOCULAR PRESSUE IN PATEINTS WITH OPEN ANGLE GLAUCOME OR OCULAR HYPERTENSION A METHOD FOR TREATMENT OF A CANCER, WHEREIN THE CANCER IS CHRONIC MYELOGENOUS LEUKEMIA A METHOD FOR THE TREATMENT OF CANCER

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

PATENT USE
U-781 U-782

ADB 41 of 51

U-783 U-784 U-785 U-786 U-787

U-788 U-789 U-790

U-791 U-792 U-793

U-794

U-795 U-796 U-797 U-798 U-799 U-800

U-801 U-802 U-803 U-804 U-805 U-806 U-807 U-808 U-809 U-810 U-811 U-812 U-813 U-814 U-815 U-816 U-817 U-818 U-819 U-820

FOR TREATMENT OF ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS WHO ARE NAIVE TO PHARMACOLOGIC THERAPY TREATMENT OF CHRONIC HEPATITIS B IN ADULT PATIENTS WITH EVIDENCE OF VIRAL REPLICATION AND EITHER EVIDENCE OF PERSISTANT ELEVATIONS IN SERUM AMINOTRANSFERASES (ALT OR AST) OR HISTOLOGICALLY ACTIVE DISEASE DESONATE GEL IS INDICATED FOR THE TREATMENT OF MILD TO MODERATE ATOPIC DERMATITIS IN PATIENTS 3 MONTHS OF AGE AND OLDER TREATMENT OF MODERATE TO SEVERE PRIMARY RESTLESS LEGS SYNDROME (RLS) USE AS REPLACEMENT SOLUTION, HEMOFILTRATION SOLUTION OR HEMODIAFILTRATION SOLUTION IN CONTINUOUS RENAL REPLACEMENT THERAPY PRODUCT IS APPROVED FOR THE TOPICAL TREATMENT OF TINEA PEDIS MAINTENANCE TREATMENT OF ASTHMA AS PROPHYLACTIC THERAPY IN ADULT AND PEDIATRIC PATIENTS SIX YEARS OF AGE OR OLDER, INCLUDING PATIENTS REQUIRING ORAL CORTICOSTEROID THERAPY FOR ASTHMA METHOD OF TREATING PSYCHIATRIC SYMPTOMS ASSOCIATED WITH PREMENSTRUAL DISORDERS USING PAROXETINE TREATMENT OF KNOWN OR SUSPECTED CYANIDE POISONING FORTEO IS INDICATED FOR THE TREATMENT OF POST MENOPAUSAL WOMEN WITH OSTEOPOROSIS WHO ARE AT RISK FOR FRACTURE. FORTEO CAN BE USED BY PEOPLE WHO HAVE HAD A FRACTURE RELATED TO OSTEOPOROSIS GLEEVEC IS ALSO INDICATED FOR THE TREATMENT OF PATIENTS WITH KIT (CD117) POSITIVE UNRESECTABLE AND/OR METASTATIC MALIGNANT GASTROINTESTINAL STROMAL TUMORS (GIST) TREATMENT OF SEBORRHEA DERMATITIS IN HUMANS FOR THE LONG TERM TREATMENT, TWICE DAILY (MORNING AND EVENING) MAINTENANCE TREATMENT OF BRONCHOCONSTRICTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND EMPHYSEMA CLOSURE OF A CLNICALLY SIGNIFICANT PATENT DUCTUS ARTERIOSUS IN PREMATURE INFANTS WEIGHING BETWEEN 500 AND 1500G, WHO ARE NO MORE THAN 32 WEEKS GESTATIONAL AGE WHEN USUAL MEDICAL MANAGEMENT IS INEFFECTIVE METHOD FOR INHIBITING NOREPINEPHRINE UPTAKE METHOD OF TREATING DEPRESSION METHOD OF TREATING ANXIETY TREATMENT AND PREVENTION OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN BY ONCE-MONTHLY ORAL ADMINISTRATION OF IBANDRONATE SODIUM MONOHYDRATE EQUIVALENT TO 150MG OF IBANDRONIC ACID METHOD FOR INHIBITING SEROTONIN UPTAKE TREATMENT OF PATIENTS WITH ADVANCED OR METASTATIC BREAST CANCER WHOSE TUMORS OVEREXPRESS HER2 AND WHO HAVE RECEIVED PRIOR THERAPY INCLUDING ANTHRACYCLINE, A TAXANE AND TRASTUZUMAB METHOD OF TREATING CANCER METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR IN COMBINATION WITH METFORMIN TREATMENT OF ACTINIC KERATOSES BY PHOTODYNAMIC THERAPY TREATMENT OF IMPETIGO DUE TO STAPHYLOCOCCUS AUREUS OR STREPTOCOCCUS PYOGENES INTRATHECAL TREATMENT OF LYMPHOMATOUS MENINGITIS PREVENTION OF EXERCISE-INDUCED BRONCHOCONSTRICTION THE TREATMENT OF THE SYMPTOMS OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS IN PATIENTS 2 YEARS OF AGE AND OLDER TREATMENT OF CHRONIC IDIOPATHIC URTICARIA METHOD OF TREATMENT TO ALLEVIATE INFLAMMATION OF THE EYE RELIEF OF SYMPTOMS ASSOCIATED WITH SEASONAL AND PERENNIAL ALLERGIC RHINITIS AND TREATMENT OF THE UNCOMPLICATED SKIN MANIFESTATIONS OF CHRONIC IDIOPATHIC URTICARIA RELIEF OF SYMPTOMS ASSOCIATED WITH SEASONAL AND PERENNIAL ALLERGIC RHINITIS MAINTENANCE TREATMENT OF BRONCHOCONSTRICTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) TREATMENT OF SCHIZOPHRENIA TREATS COLD SORES/FEVER BLISTERS ON THE FACE OR LIPS. SHORTENS HEALING TIME AND DURATION OF SYMPTOMS: TINGLING, PAIN, BURNING AND/OR ITCHING DEPRESSION, PANIC DISORDER, PREMENSTRUAL DISORDERS AND SOCIAL ANXIETY DISORDER NASAL ADMINISTRATION OF CYANOCOBALAMIN TOPICAL TREATMENT OF ACNE VULGARIS MANAGEMENT OF FIBROMYALGIA IMPROVED WAKEFULNESS IN PATIENTS WITH EXCESSIVE SLEEPINESS ASSOCIATED WITH NARCOLEPSY, OBSTRUCTIVE SLEEP APNEA/HYPOPNEA SYNDROME, AND SHIFT WORK SLEEP DISORDER

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

PATENT USE
U-821 U-822 U-823

ADB 42 of 51

U-824 U-825 U-826 U-827 U-828 U-829 U-830 U-831 U-832 U-833 U-834 U-835 U-836 U-837 U-838 U-839 U-840 U-841 U-842 U-843 U-844

U-845 U-846 U-847

U-848 U-849

U-850 U-851 U-852 U-853 U-854 U-855 U-856

U-857 U-858 U-859

U-860 U-861

METHOD OF INHIBITING ENTHOTHELIN RECEPTORS BY ADMINISTERING AMBRISENTAN TO A PATIENT TO TREAT PULMONARY ARTERIAL HYPERTENSION. USE IN LIPID MANAGEMENT RELIEF OF SYMPTOMS ASSOCIATED WITH SEASONAL ALLERGIC RHINITIS AND FOR THE TREATMENT OF UNCOMPLCATED SKIN MANIFESTATIONS OF CHRONIC IDIOPATHIC URTICARIA IN CHILDREN 6 TO 11 YEARS OF AGE METHOD OF TREATING PATIENTS INFECTED WITH CCR5-TROPIC HIV-1 USE FOR PREVENTION OF BREAST CANCER RELIEF OF MODERATE TO SEVERE PAIN USE FOR TREATMENT OF DIABETES, PARTICULARLY TYPE 2 DIABETES PREVENTION OF PREGNANCY IN WOMEN WHO ELECT TO USE ORAL CONTRACEPTIVES AS A METHOD OF CONTRACEPTION TREATMENT OF EXTRAVASATION RESULTING FROM IV ANTHRACYCLINE CHEMOTHERAPY TREATMENT OF RELAPSED SMALL CELL LUNG CANCER METHOD OF ADMINISTERING LANREOTIDE ACETATE ZINGO IS INDICATED FOR THE USE ON INTACT SKIN TO PROVIDE LOCAL ANALGESIA PRIOR TO VENIPUNCTURE OR INTRAVENOUS CANNULATION. METHOD OF TREATING PAIN USING A PHARMACEUTICALLY ACCEPTABLE SALT OF ROPIVACAINE AND ADMINISTERING A COMPOSITION CONTAINING LESS THAN 0.25% BY WEIGHT OF ROPIVACAINE INVIRASE IN COMBINATION WITH RITONAVIR AND OTHER ANTIRETROVIRAL AGENTS IS INDICATED FOR THE TREATMENT OF HIV INFECTION RELIEF OF THE INFLAMMATORY AND PRURITIC MANIFESTATIONS OF ATOPIC DERMATITIS IN PATIENTS ONE YEAR OF AGE OR OLDER A METHOD FOR THE TREATMENT OF LEUKEMIAS GASTROINTESTINAL LAVAGE INDICATED FOR CLEANSING OF THE COLON AS A PREPARATION FOR COLONOSCOPY IN ADULTS METHOD OF TREATING PAIN USING A PHARMACEUTICALLY ACCEPTABLE SALT OF ROPIVACAINE AND ADMINISTERING A COMPOSITION CONTAINING LESS THAN 0.5% BY WEIGHT OF ROPIVACAINE TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD) TREATMENT FOR TYPE 2 DIABETES MELLITUS INDICATED FOR THE LONG-TERM, MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS 12 YEARS OF AGE AND OLDER INDICATED FOR THE TREATMENT OF ATTENTION-DEFICIT/HYPERACTIVITY DISORDER (ADHD) METHOD FOR ADMINISTRATION OF TESTOSTERONE PREFEST IS INDICATED IN WOMEN WHO HAVE A UTERUS FOR THE TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE; TREATMENT OF VULVAR AND VAGINAL ATROPHY; PREVENTION OF OSTEOPOROSIS TREATMENT OF PATIENTS WITH CANDIDEMIA, ACUTE DISSEMINATED CANDIDIASIS, CANDIDA PERITONITIS AND ABCESSES USE FOR DELINEATION (VISUALIZATION) DURING A VITRECTOMY SURGICAL PROCEDURE ADJUNCTIVE THERAPY TO DIET IN ADULTS TO REDUCE LDL-C, TRIGLYCERIDES AND APO B, AND INCREASE HDL-C IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA OR MIXED DYSLIPIDEMIA (TYPES IIA, IIB) AND TO TREAT HYPERTRIGLYCERIDEMIA (TYPES IV, V) ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA REDUCTION OF ELEVATED INTRAOCULAR PRESSURE (IOP) IN PATIENTS WITH GLAUCOMA OR OCULAR HYPERTENSION WHO REQUIRE ADJUNCTIVE OR REPLACEMENT THERAPY DUE TO INADEQUATELY CONTROLLED IOP. DOSE IS ONE DROP OF COMBIGAN IN THE AFFECTED EYE TWICE DAILY PREVENTION OR TREATMENT OF NAUSEA OR EMESIS INDUCED BY A CANCER CHEMOTHERAPEUTIC AGENT TREATMENT OF TYPE 2 DIABETES MELLITUS RELIEF OF SYMPTOMS ASSOCIATED WITH SEASONAL AND PERENNIAL ALLERGIC RHINITIS TREATMENT OR PREVENTION OF EMESIS PREVENTION OF CMV DISEASE IN KIDNEY, HEART, AND KIDNEY-PANCREAS TRANSPLANT PATIENTS AT HIGH RISK (DONOR CMV SEROPOSITIVE/RECIPIENT CMV SERONEGATIVE) METHOD TO INDUCE NATRIURESIS, DIURESIS AND/OR VASODILATION SUPPORT EMBRYO IMPLANTATION AND EARLY PREGNANCY BY SUPPLEMENTATION OF CORPUS LUTEAL FUNCTION AS PART OF AN ASSISTED REPORDUCTIVE TECHNOLOGY (ART) TREATMENT PROGRAM FOR INFERTILE WOMEN INHIBITION OF TRANSPLANT REJECTION PEDIATRIC USE AGED 1-11 YEARS, GERD AND EROSIVE ESOPHAGITIS EROSIVE ESOPHAGITIS, HYPERSECRETORY CONDITIONS INCLUDING ZOLLINGER-ELLISON SYNDROME, MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS AND REDUCTION OF SYMPTOMS IN PATIENTS WITH GERD FOR THE APPROVED USES AND CONDITIONS OF USE, INCLUDING DEPRESSION RELIEF OF THE INFLAMMATORY AND PRURITIC MANIFESTATIONS OF CORTICOSTEROID RESPONSIVE DERMATOSES IN PATIENTS 12 YEARS OF AGE OR OLDER

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

PATENT USE
U-862

ADB 43 of 51

U-863 U-864 U-865 U-866 U-867 U-868 U-869 U-870 U-871 U-872

U-873 U-874 U-875 U-876 U-877 U-878 U-879 U-880

U-881 U-882 U-883 U-884 U-885 U-886 U-887 U-888 U-889 U-890 U-891 U-892 U-893 U-894 U-895 U-896 U-897 U-898 U-899 U-900 U-901 U-902 U-903 U-904 U-905

ADJUNCT TO DIET TO REDUCE ELEVATED TOTAL-C, LDL-C, NON-HDL-C, APO B, TG, AND LP(A) LEVELS AND TO INCREASE HDL-C IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA, MIXED DYSLIPIDEMIA, AND HYPERTRIGLYCERIDEMIA TAKING ASPIRIN OR NON-STEROIDAL ANTI-INFLAMMATORY MEDICATIONS APPROXIMATELY 30 MINUTES BEFORE DOSING CAN MINIMIZE FLUSHING, A COMMON SIDE EFFECT OF NIACIN THERAPY PEDIATRIC USE AGES 1-2 YEARS, GERD AND EROSIVE ESOPHAGITIS TREATMENT OF A WOMAN WITH OSTEOPOROSIS AND A HIGH RISK FOR BONE FRACTURE BY REDUCING THE RISK OF VERTEBRAL AND NONVERTEBRAL BONE FRACTURE THE LABEL REFERENCES THE EFFECTS OF THE ACTIVE INGREDIENT OF REVLIMID UPON CYTOKINES TREATMENT OF MIGRAINE METHOD OF USING ANTAGONIST OF ARGININE VASOPRESSIN (AVA) V1A AND V2 RECEPTORS FOR INTRAVENOUS TREATMENT OF PATIENTS WITH HYPERVOLEMIC HYPONATREMIA METHOD FOR STIMULATING CORONOARY VASODILATION FOR PURPOSES OF IMAGING THE HEART METHOD OF PRODUCING CORONARY VASODILATION WITHOUT PERIPHERAL VASODILATION METHOD OF REDUCING RISK OF MYOCARDIAL INFARCTION, STROKE AND DEATH TWICE DAILY MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND EMPHYSEMA. TO REDUCE EXACERBATIONS OF COPD IN PATIENTS WITH A HISTORY OF EXACERBATIONS METHOD OF TREATING CONSTIPATION IN A PATIENT WITH IRRITABLE BOWEL SYNDROME BY OPENING CHLORIDE CHANNELS (CIC) METHOD OF TREATING CONSTIPATION IN A PATIENT WITH IRRITABLE BOWEL SYNDROME FIRST-LINE TREATMENT OF LOCALLY ADVANCED UNRESECTABLE OR METASTATIC PANCREATIC CANCER, IN COMBINATION WITH GEMCITABINE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA FOR USE AS ADJUNCTIVE THERAPY IN THE TREATMENT OF PEPTIC ULCER A METHOD FOR BINDING A PERIPHERAL OPIOID RECEPTOR A METHOD OF TREATING OR PREVENTING ILEUS ENDOMETRIN IS A PROGESTERONE INDICATED TO SUPPORT EMBRYO IMPLANTATION AND EARLY PREGNANCY BY SUPPLEMENTATION OF CORPUS LUTEAL FUNCTION AS PART OF AN ASSISTED REPRODUCTIVE TECHNOLOGY (ART) TREATMENT PROGRAM FOR INFERTILE WOMEN TREATMENT OF NON-SMALL CELL LUNG CANCER MANAGEMENT OF FIBROMYALGIA (FM) TREATMENT OF GASTROINTESTINAL STROMAL TUMOR WITH SUNITINIB TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA TREATMENT OF PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST 1 PRIOR THERAPY ADMINISTERING DESLORATADINE TO TREAT THE SYMPTOMS OF PERENNIAL ALLERGIC RHINITIS, SEASONAL ALLERGIC RHINITIS, OR CHRONIC IDIOPATHIC URTICARIA TREATMENT AND PREVENTION OF OSTEOPOROSIS FEMALE HORMONE REPLACEMENT THERAPY FOR POSTMENOPAUSAL WOMEN MENOPAUSAL AND POSTMENOPAUSAL DISORDERS (INCLUDING VASOMOTOR SYMPTOMS ASSOCCIATED WITH MENOPAUSE) REDUCTION OF SERUM PHOSPHATE IN PATIENTS WITH END STAGE RENAL DISEASE USE AS AN INTRAOCULAR IRRIGATING SOLUTION DURING SURGICAL PROCEDURES INVOLVING PERFUSION OF THE EYE TREATMENT OF CUTANEOUS MANIFESTATIONS IN PATIENTS WTIH CUTANEOUS T-CELL LYMPHOMA (CTCL) CLEVIPREX IS A DIHYDROPYRIDINE CALCIUM CHANNEL BLOCKER INDICATED FOR THE REDUCTION OF BLOOD PRESSURE WHEN ORAL THERAPY IS NOT FEASIBLE OR NOT DESIRABLE TREATMENT OF COLD SORES IN PEDIATRIC PATIENTS TWELVE YEARS OF AGE AND OLDER TREATMENT OF HIV INFECTION IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS TREATMENT OF NASAL SYMPTOMS OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS IN ADULTS AND CHILDREN TWO YEARS OF AGE AND OLDER METHOD OF TREATING TONSILLITIS AND/OR PHARYNGITIS SECONDARY TO STREPTOCOCCUS PYOGENES IN A ONCE-A-DAY AMOXICILLIN PRODUCT USE OF GLUTAMINE TOGETHER WITH GROWTH HORMONE FOR THE TREATMENT OF PATIENTS WITH SHORT BOWEL SYNDROME USE OF THALIDOMIDE IN COMBINATION WITH DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA INTEGRASE INHIBITION FOR THE TREATMENT OF HIV INFECTION PREVENTION OF POSTOPERATIVE NAUSEA AND VOMITING USE IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF BENIGN PROSTATIC HYPERPLASIA (BPH) TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) IN ADULT PATIENTS TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE TREATMENT OF MODERATE TO SEVERE VAGINAL DRYNESS AND PAIN WITH INTERCOURSE, SYMPTOMS OF VULVAR AND VAGINAL ATROPHY, ASSOCIATED WITH MENOPAUSE

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

PATENT USE
U-906

ADB 44 of 51

U-907 U-908 U-909 U-910 U-911 U-912 U-913 U-914 U-915 U-916 U-917 U-918 U-919 U-920

U-921 U-922 U-923 U-924 U-925 U-926

U-927 U-928 U-929 U-930 U-931 U-932

U-933

U-934

U-935

U-936

U-937 U-938 U-939 U-940 U-941 U-942 U-943 U-944 U-945 U-946

PROPHYLAXIS OF ORGAN REJECTION IN KIDNEY, LIVER AND HEART ALLOGENIC TRANSPLANTS; TREATMENT OF PATIENTS WITH SEVERE ACTIVE, RHEUMATOID ARTHRITIS; TREATMENT OF ADULT, NONIMMUNOCOMPROMISED PATIENTS WITH SEVERE, RECALCITRANT, PLAQUE PSORIASIS FOR THE MAINTENANCE OF REMISSION OF ULCERATIVE COLITIS IN SUBJECTS 18 YEARS OF AGE AND OLDER PROPHYLAXIS OF ORGAN REJECTION IN PATIENTS RECEIVING ALLOGENEIC RENAL TRANSPLANTS TREATMENT OF CYSTIC FIBROSIS PATIENTS WITH PSEUDOMONAS AERUGINOSA TREATMENT OF METASTATIC CARCINOMA OF THE OVARY AFTER FAILURE OF INITIAL OR SUBSEQUENT CHEMOTHERAPY METHOD OF TREATING, AS ADJUNCTIVE THERAPY, PARTIAL-ONSET SEIZURES IN A PATIENT WITH EPILEPSY AGED 17 YEARS AND OLDER WHEN ORAL TREATMENT IS TEMPORARILY NOT FEASIBLE SEDATION OF NON-INTUBATED PATIENTS PRIOR TO AND/OR DURING SURGICAL AND OTHER PROCEDURES TREATMENT OF OVERACTIVE BLADDER WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND FREQUENCY METHOD OF TREATING, AS ADJUNCTIVE THERAPY, PARTIAL-ONSET SEIZURES IN A PATIENT WITH EPILEPSY AGED 17 YEARS AND OLDER TREATMENT OF MUSCULOSKELETAL CONDITIONS TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OR OLDER TREATMENT OF INFLAMMATORY LESIONS OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS TO TREAT OR PREVENT INFECTIONS CAUSED BY SUSCEPTIBLE BACTERIA USING DELAYED-RELEASE TABLETS CONSISTING OF DOXYCYCLINE HYCLATE COATED PELLETS IN A TABLET FOR THE TREATMENT OF DERMATITIS STEROID-RESPONSIVE INFLAMMATORY OCULAR CONDITIONS FOR WHICH A CORTICOSTEROID IS INDICATED AND WHERE SUPERFICIAL BACTERIAL OCULAR INFECTION OR A RISK OF BACTERIAL OCULAR INFECTION EXISTS TREATMENT OF ACNE VULGARIS FOR THE TREATMENT OF FUNGAL INFECTIONS METHOD OF TREATING OPHTHALMIC INFLAMMATION AND INFECTION TREATMENT OF MILD TO MODERATE INFECTION CAUSED ABY SUSCEPTIBLE STRAINS TREATMENT OF ONLY INFLAMMATORY LESIONS (PAPULES AND PUSTILES) OF ROSACEA MGT SPECIFIC BACTERIAL INFECTIONS. TREATMENT PTS W/ COMMUNITY ACQUIRED PNEUMONIA OR BACTERIAL SINUSITIS DUE TO CONFIRMED, OR SUSPECTED B-LACTAMASE PRODUCING PATHOGENS & S. PNEUMONIAE WITH REDUCED SUSCEPTIBILITY TO PENICILLIN (MIC=2MC/ML) METHOD FOR INCREASING TEAR PRODUCTION TREATMENT OF BACTERIAL INFECTIOUS DISEASE TREATMENT OF OBSESSIVE COMPULSIVE DISORDER TREATABLE WITH AN SSRI TREATMENT OF IDIOPATHIC THROMBOCYTOPENIC PURPURA (ITP) RELIEF OF MODERATE TO SEVERE ACUTE PAIN PYLERA CAPSULES, IN COMBINATION WITH OMEPRAZOLE ARE INDICATED FOR THE TREATMENT OF PATIENTS WITH HELICOBACTER PYLORI INFECTION AND DUODENAL ULCER DISEASE TO ERADICATE H. PYLORI FOR THE TREATMENT OF PATIENTS WITH HELICOBACTER PYLORI INFECTION AND DUODENAL ULCER DISEASE TO ERADICATE H. PYLORI. THE ERADICATION OF HELICOBACTER PYLORI HAS BEEN SHOWN TO REDUCE THE RISK OF DUODENAL ULCER RECURRENCE IN COMBINATION WITH GRANULOCYTE-COLONY STIMULATING FACTOR (G-CSF) TO MOBILIZE HEMATOPOIETIC STEM CELL TO THE PERIPHERAL BLOOD FOR COLLECTION AND SUBSEQUENT AUTOLOGOUS TRANSPLANTATION WITH NON-HODGKINS LYMPHOMA AND MULTIPLE MYELOMA TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION IN ADULT PATIENTS, AND TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER USE IN COMBINATION WITH GRANULOCYTE-COLONY STIMULATING FACTOR (G-CSF) TO MOBILIZE HEMATOPOIETIC STEM CELLS TO PERIPHERAL BLOOD FOR COLLECTION & SUBSEQUENT AUTOLOGOUS TRANSPLANTATION IN PATIENTS WITH NON-HODGKIN'S LYMPHOMA & MULTIPLE MYELOMA TREATMENT OF PROSTATE CANCER TREATMENT OF HAIR LOSS AND HYPOTRICHOSIS OF THE EYELASHES BY INCREASING THEIR GROWTH INCLUDING LENGTH, THICKNESS AND DARKNESS TREATMENT OF HYPOTRICHOSIS OF THE EYELASHES BY INCREASING AND STIMULATING THEIR GROWTH INCLUDING LENGTH, THICKNESS AND DARKNESS METHOD TO TREAT AIDS-RELATED KAPOSI'S SARCOMA METHOD TO TREAT OVARIAN CANCER METHOD TO TREAT MULTIPLE MYELOMA GNRH ANTAGONIST INDICATED FOR TREATMENT OF PATIENTS WITH ADVANCED PROSTATE CANCER TREATMENT OF PATIENTS WITH B-CELL CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) SEDATIVE-HYPNOTIC AGENT INDICATED FOR MONITORED ANESTHESIA CARE (MAC) SEDATION TREATMENT OF BREAST CANCER

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

PATENT USE
U-947

ADB 45 of 51

U-948 U-949 U-950 U-951 U-952 U-953 U-954 U-955 U-956 U-957 U-958

U-959

U-960 U-961 U-962 U-963 U-964 U-965 U-966 U-967

U-968 U-969 U-970 U-971 U-972 U-973

U-974 U-975 U-976 U-977 U-978 U-979 U-980 U-981

U-982 U-983 U-984 U-985 U-986

WHEN PATIENTS ARE UNABLE TO TAKE THE ORAL FORMULATIONS, PREVACID IV, FOR INJECTION IS INDICATED AS AN ALTERNATIVE FOR THE SHORT-TERM TREATMENT (UP TO 7 DAYS) OF ALL GRADES OF EROSIVE ESOPHAGITIS TREATMENT OF DIABETES MELLITUS HEALING OF ALL GRADES OF EROSIVE ESOPHAGITIS (EE) FOR UP TO 8 WEEKS MAINTAIN HEALING OF EROSIVE ESOPHAGITIS (EE) FOR UP TO 6 MONTHS TREATMENT OF HEARTBURN ASSOCIATED WITH NON-EROSIVE GASTROESOPHAGEAL REFLUX DISEASE (GERD) FOR 4 WEEKS USE AS AN ANALGESIC METHOD OF TREATING OPHTHALMIC INFLAMMATION AND INFECTION CHRONIC MANAGEMENT OF HYPERURICEMIA IN PATIENTS WITH GOUT. NOT RECOMMENDED FOR THE TREATMENT OF ASYMPTOMATIC HYPERURICEMIA PROPHYLACTIC TREATMENT OF MIGRAINE TREATMENT OF PATIENTS WITH H. PYLORI INFECTION AND DUODENAL ULCER DISEASE A METHOD OF TREATING CANCER IN A PATIENT COMPRISING ADMINISTERING IXABEPILONE OR PHARMACEUTICAL COMPOSITIONS COMPRISING IXABEPILONE METHOD OF TREATING PATIENT COMPRISING MIXING FIRST AND SECOND VIALS OF PRODUCT COMPRISING LYOPHILIZED IXABEPILONE TO PROVIDE AN EPOTHILONE ANALOG SOLUTION, DILUTING SOLUTION WITH A SUITABLE DILUENT TO PREPARE INTRAVENOUS FORMULATION FOR PT METHOD OF TREATING CANCER, IV ADMIN, LYOPHYLIZED IXABEPILONE DILUTED, EVERY WEEK OR 3 WEEKS; LYOPHILIZED IXABEPILONE WITH SOLVENT(DEHYDRATED ETHANOL) DILUTED TO CONCENTRATION OF 0.1MG/ML TO 0.9MG/ML METHOD OF TREATING CANCER IN A PATIENT COMPRISING INTRAVENOUSLY ADMINISTERING TO THE PATIENT IXABEPILONE DILUTED IN A PARENTERAL DILUENT METHOD OF TREATING BREAST CANCER BY ADMINISTERING IXABEPILONE; A METHOD OF TREATING A CANCER RESPONSIBLE TO MICROTUBULE STABILIZATION BY ADMINISTERING IXABEPILONE SYMBYAX IS INDICATED FOR THE ACUTE TREATMENT OF TREATMENT RESISTANT DEPRESSION IN ADULTS PROZAC AND OLANZAPINE IN COMBINATION FOR THE ACUTE TREATMENT OF TREATMENT RESISTANT DEPRESSION IN ADULTS ZYPREXA ZYDIS AND FLUOXETINE IN COMBINATION FOR THE ACUTE TREATMENT OF TREATMENT RESISTANT DEPRESSION IN ADULTS USE OF IXABEPILONE IN COMBINATION WITH CAPECITABINE IN TREATMENT OF METASTASIS BREAST CANCER TREATMENT OF ASTHMA (MAINTENANCE AND PROPHYLACTIC THERAPY) A METHOD OF REVERSING SOFT-TISSUE ANESTHESIA I.E. ANESTHESIA OF THE LIP AND TONGUE, AND THE ASSOCIATED FUNCTIONAL DEFICITS RESULTING FROM AN INTRAORAL SUBMUCOSAL INJECTION OF A LOCAL ANESTHETIC A METHOD FOR IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS TREATMENT OF MIGRAINE TOPICAL TREATMENT OF LICE INFESTATIONS INDICATED FOR THE ACUTE TREATMENT OF ADULTS WITH SCHIZOPHRENIA MONOTHERAPY OR AS ADJUNCTIVE THERAPY TO LITHIUM OR VALPROATE FOR THE MAINTENANCE TREATMENT OF BIPOLAR I DISORDER ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS WHO ARE ALREADY TREATED WITH PIOGLITAZONE AND METFORMIN OR WHO HAVE INADEQUATE GLYCEMIC CONTROL ON PIOGLITAZONE OR METFORMIN ALONE ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2 DIABETES WHO ARE ALREADY TREATED WITH A PIOGLITAZONE AND METFORMIN TREATMENT OF PULMONARY HYPERTENSION IMPROVEMENT OF GLYCEMIC CONTROL IN INDIVIDUALS WITH TYPE 2 DIABETES TREATMENT OF ACUTE, UNCOMPLICATED MALARIA INFECTION DUE TO PLASMODIUM FALCIPARUM IN PATIENTS OF 5KG BODYWEIGHT AND ABOVE METHOD OF TREATING HYPONATREMIA RELIEF OF MUSCLE SPASM NONSTEROIDAL ANTI-INFLAMMATORY DRUG INDICATED FOR RELIEF OF MILD TO MODERATE ACUTE PAIN MANAGEMENT OF MILD TO MODERATE PAIN, MANAGEMENT OF MODERATE TO SEVERE PAIN AS AN ADJUNCT TO OPIOID ANALGESICS, REDUCTION IN FEVER THROUGH ANTI-INFLAMMATORY, ANALGESIC, AND ANTIPYRETIC ACTIVITY A METHOD OF TREATING OSTEOPOROSIS METHOD OF TREATING OSTEOPOROSIS IN A POST-MENOPAUSAL WOMAN AT RISK FOR FRACTURE METHOD FOR THE TREATMENT OF A WOMAN WITH OSTEOPOROSIS AND AT RISK FOR BONE FRACTURE TREATMENT OF MACULAR EDEMA FOLLOWING BRANCH RETINAL VEIN OCCLUSION (BRVO) OR CENTRAL RETINAL VEIN OCCLUSION (CRVO) TREATMENT OF PATIENTS INFECTED WITH PEDICULUS HUMANUS CAPITIS (HEAD LICE AND THEIR OVA) OF THE SCALP HAIR

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

PATENT USE
U-987 U-988 U-989 U-990 U-991 U-992 U-993 U-994 U-995 U-996

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U-997 U-998

U-999 U-1000 U-1001

U-1002 U-1003 U-1004 U-1005 U-1006

U-1007 U-1008 U-1009 U-1010

U-1011 U-1012 U-1013 U-1014 U-1015 U-1016

U-1017 U-1018 U-1019 U-1020 U-1021 U-1022 U-1023 U-1024

U-1025 U-1026 U-1027 U-1028 U-1029 U-1030

TREATMENT OF SECONDARY HYPERPARATHYROIDISM IN PATIENTS WITH CHRONIC KIDNEY DISEASE ON DIALYSIS TREATMENT OF RHINITIS COMPRISING THE NASAL APPLICATION OF A PHARMACEUTICAL FORMULATION AS CLAIMED IN US PATENT 7541350 FOR REDUCING BLOOD PHENYLALANINE LEVELS IN A HUMAN SUFFERING FROM HYPERPHENYLALANINEMIA TREATMENT OF PROTOZOAL INFECTION TREATMENT OR PROPHYLAXIS OF THROMBOSIS OR EMBOLISMS REDUCTION OF THE RISK OF CARDIOVASCULAR HOSPITALIZATION METHOD OF TREATING INFERTILITY METHOD OF TREATMENT OF OSTEOPOROSIS WHEREIN THE OSTEOPOROSIS IS STEROID-INDUCED METHOD FOR TREATING TYPE II DIABETES BY ADMINISTERING SAXAGLIPTIN AN ADJUNCTIVE THERAPY TO DIET TO REDUCT ELEVATED TOTAL CHLORESTEROL (TC), LOW-DENSITY LIPOPROTEIN CHOLESTEROL, APOLIPOPROTEIN B, TRIGLYCERIDES, AND TO INCREASE HDL-C IN ADULT PATIENTS WITH PRIMARY HYPERLIPIDEMIA OR MIX DYSLIPIDEMIA TREATMENT OF MAJOR DEPRESSIVE DISORDER BY DOSING AT INTERVALS OF 24 HOURS ADJUNCITVE THERAPY TO DIET TO REDUCE ELEVATED TOTAL CHOLESTEROL, LOW-DENSITY LIPOPROTEIN CHOLESTEROL, APOLIPOPRTEIN B, TRIGLYCERIDES AND TO INCREASE HDL-C IN ADULT PATIENTS WITH PRIMARY HYPERLIPIDEMIA OR MIXED DYSLIPIDEMIA TREATMENT OF CHRONIC HEPATITIS B IN ADULT PATIENTS ADJUNCTIVE THERAPY TO DIET IN PATIENTS WITH HYPERLIPIDEMIAS METHOD FOR DELIVERING DRUG TO LUNG OF MAMMAL, COMPRISING ADMINISTERING DRUG PRODUCT BY INHALATION. TREATING A MAMMAL HAVING A CONDITION CAPABLE OF TREATMENT BY INHALATION, COMPRISING ADMINISTERING TO THE LUNG THE DRUG PRODUCT BY INHALATION METHOD OF TREATING INFLAMMATORY CONDITIONS A METHOD OF MYOCARDIAL PERFUSION IMAGING AND INCREASING CORONARY BLOOD FLOW TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY PERIPHERAL T-CELL LYMPHOMA METHOD OF TREATING A STAPHYLOCOCCAL INFECTION NEW COMBINATION PRODUCT FOR THE EARLY TREATMENT OF RECURRENT HERPES LABIALIS (COLD SORES) TO REDUCE THE LIKELIHOOD OF ULCERATIVE COLD SORES AND TO SHORTEN THE LESION HEALING TIME IN ADULTS AND ADOLESCENTS (12 YEARS OF AGE AND OLDER) METHOD OF TREATING GOUT FLARES APPLICATION OF ANTISEPTIC WITH MOISTURIZERS FOR SURGICAL AND HEALTHCARE PERSONNEL SKIN DISINFECTION METHOD FOR ADMINISTRATION OF TESTOSTERONE TO REDUCE BLOOD PHENYLALANINE LEVELS IN PATIENTS WITH HYPERPHENYLALANINEMIA DUE TO TETRA HYDROBIOPTERIN RESPONSIVE PHENYLKETONURIA. KUVAN SHOULD BE TAKEN ORALLY WITH FOOD TO INCREASE ABSORPTION USE OF GRANISETRON TRANSDERMAL SYSTEM TO TREAT/PREVENT CHEMOTHERAPY INDUCED NAUSEA AND VOMITING METHOD FOR TREATING INSOMNIA WHILE REDUCING THE RISK OF AN ADVERSE DRUG INTERACTION METHOD OF USING RIBAVIRIN IN COMBINATION WITH PEGYLATED INTERFERON ALPHA-2B TO TREAT PATIENTS WITH CHRONIC HEPATITIS C METHOD OF USING RIBAVIRIN IN COMBINATION WITH INTERFERON ALPHA-2B(PEGYLATED AND NONPEGYLATED) TO TREAT PATIENTS WITH CHRONIC HEPATITIS C TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY PERIPHERAL T-CELL LYMPHOMA IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS FOR THE TREATMENT OF HIV-1 INFECTION IN TREATMENT-EXPERIENCED ADULT PATIENTS, WHO HAVE EVIDENCE OF VIRAL REPLICATION AND HIV-1 STRAINS RESISTANT TO AN NNRTI AND OTHER ANTIRETROVIRAL AGENTS A METHOD OF TREATING NASAL AND NON-NASAL SYMPTOMS OF SEASONAL ALLERGIC RHINITIS TREATMENT OF PULMONARY HYPERTENSION BY INHALATION TREATMENT OF PULMONARY HYPERTENSION METHOD OF USING COLCHICINE FOR THE PROPHYLAXIS OF GOUT FLARES SHORT-TERM TREATMENT (4-8 WEEKS) OF ACTIVE BENIGN GASTRIC ULCER FOR THE PREPARATION OF SKIN PRIOR TO SURGERY; HELPS REDUCE BACTERIA THAT CAN POTENTIALLY CAUSE SKIN INFECTION TREATMENT OF ATROPHIC VAGINITIS DUE TO MENOPAUSE REDUCTION OF ELEVATED INTRAOCULAR PRESSURE IN PATIENTS WITH GLAUCOMA OR OCULAR HYPERTENSION WHO REQUIRE ADJUNCTIVE OR REPLACEMENT THERAPY DUE TO INADEQUATELY CONTROLLED IOP TREATING FREQUENT HEARTBURN A METHOD OF TREATING HUMAN SUFFERING FROM OR SUSCEPTIBLE TO PSYCHOSIS. REDUCTION OF ELEVATED PLASMA STEROL AND/OR STANOL LEVELS IN A MAMMAL A METHOD OF DISTRIBUTING SODIUM OXYBATE UNDER CONTROL OF A CENTRAL PHARMACY METHOD FOR TREATING ACUTE ELEVATIONS OF BLOOD PRESSURE IN HUMAN SUBJECT IN NEED THEREOF IMPROVEMENT OF WALKING IN PATIENTS WITH MULTIPLE SCLEROSIS (MS)

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

PATENT USE

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U-1031 IMPROVE RESPIRATORY SYMPTOMS IN CYSTIC FIBROSIS IN PATIENTS WITH PSEUDOMONAS AERUGINOSA U-1032 USE OF ROSUVASTATIN CALCIUM FOR THE PRIMARY PREVENTION OF CARDIOVASCULAR DISEASE IN INDIVIDUALS WITHOUT CLINICALLY EVIDENT CORONARY HEART DISEASE BUT WITH INCREASED RISK FACTORS U-1033 TOPICAL TREATMENT OF ACNE VULGARIS U-1034 TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) IN ADULTS U-1035 NONSTEROIDAL ANTI-INFLAMMATORY DRUG INDICATED FOR RELIEF OF MILD TO MODERATE ACUTE PAIN U-1036 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-4 INHIBITOR IN COMBINATION WITH INSULIN U-1037 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR IN COMBINATION WITH A PPAR-GAMMA AGONIST U-1038 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-4 INHIBITOR IN COMBINATION WITH METFORMIN AND A PPAR-GAMMA AGONIST U-1039 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-4 INHIBITOR IN COMBINATION WITH METFORMIN U-1040 INHIBITION OF THROMBIN IN A PATIENT U-1041 TREATMENT OF DISORDERS RESPONSIVE TO GROWTH HORMONE U-1042 METHOD FOR STIMULATING CORONARY VASODILATION FOR PURPOSES OF IMAGING THE HEART U-1043 MANAGEMENT OF MODERATE TO SEVERE PAIN U-1044 TOPICAL TREATMENT OF SCALP PSORIASIS U-1045 MAINTENANCE TREATMENT IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NSCLC WHO HAVE NOT PROGRESSED ON 1ST-LINE TREATMENT WTH PLATINUM-BASED CHEMOTHERAPY U-1046 MAINTENANCE TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NSCLC WHOSE DISEASE HAS NOT PROGRESSED AFTER FOUR CYCLES PLATINUM-BASED CHEMOTHERAPY U-1047 TREATMENT OF BIOPSY-CONFIRMED, PRIMARY SUPERFICIAL BASAL CELL CARCINOMA (SBCC) U-1048 WORKS THROUGH THE INDUCTION OF INTERFERON AND OTHER CYTOKINES U-1049 PROPHYLAXIS OF ORGAN REJECTION IN ADULT PATIENTS AT LOW-MODERATE IMMUNOLOGIC RISK RECEIVING A RENAL TRANSPLANT U-1050 USE OF METAXALONE FOR TREATMENT OF MUSCULSKELETAL CONDITIONS U-1051 TREATMENT OF OROPHARYNGEAL CANDIDIASIS U-1052 RELIEF OF SIGNS AND SYMPTOMS OF ARTHRITIS AND RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER U-1053 RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER U-1054 ONYCHOMYCOSIS OF THE TOENAIL CAUSED BY TRICOPHYTON RUBRUM OR TRICHOPHYTON MENTAGROPHYTES, ONCE DAILY USE FOR 12 CONSECUTIVE WEEKS U-1055 AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS WHO ARE ALREADY TREATED WITH A THIAZOLIDINEDIONE (TZD) AND METFORMIN OR WHO HAVE INADEQUATE GLYCEMIC CONTROL ON A TZD OR METFORMIN ALONE U-1056 TREATMENT OF PAIN USING A NASAL SPRAY OF KETOROLAC TROMETHAMINE U-1057 TREATMENT OF INFLAMMATION AND PAIN USING A NASAL SPRAY OF KETOROLAC TROMETHAMINE U-1058 USE OF THALIDOMIDE IN COMBINATION WITH DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA U-1059 ADJUNCTIVE THERAPY TO DIET TO PATIENTS WITH HYPERTRIGLYCERIDEMIA U-1060 ADJUNCTIVE THERAPY TO DIET IN PATIENTS WITH ELEVATED CHOLESTEROL AND/OR LIPID LEVELS U-1061 ADJUNCTIVE THERAPY TO DIET IN PATIENTS WITH MIXED DYSLIPIDEMIA U-1062 ADMINISTRATION OF APPROVED PRODUCT FOR TREATMENT OF ALZHEIMER'S DISEASE U-1063 TREATMENT OF ONLY INFLAMMATORY LESIONS (PAPULES AND PUSTULES) OF ROSACEA U-1064 TREATMENT OF BIPOLAR DISORDER AND SCHIZOPHRENIA U-1065 METHOD OF TREATING ANDROGEN RESPONSIVE OR MEDICATED CONDITION IN A MAMMAL BY ADMINISTERING A SAFE & EFFECTIVE AMOUNT OF DUTASTERIDE OR A PHARMACEUTICALLY ACCEPTABLE SOLVATE THEREOF.. CONDITIONS INCLUDE BENIGN PROSTATIC HYPERTROPHY U-1066 METHOD OF TREATING AN ANDROGEN RESPONSE OR MEDIATED DISEASE IN A MAMMAL BY ADMININSTERING AN EFFECTIVE ANDROGEN RESPONSIVE OR MEDICATED DISEASE AMOUNT OF DUTASTERIDE..CONDITIONS INCLUDE BENIGN PROSTATIC HYPERPLASIA U-1067 TREATMENT OF CANCER U-1068 TREATMENT OF ASTHMA U-1069 A METHOD OF TREATING A PATIENT WITH A PRESCRIPTION DRUG USING AN EXCLUSIVE COMPUTER DATABASE IN A COMPUTER SYSTEM FOR DISTRIBUTION U-1070 A METHOD TO CONTROL ABUSE OF A SENSITIVE DRUG BY CONTROLLING WITH A COMPUTER PROCESSOR THE DISTRIBUTION OF THE SENSITIVE DRUG VIA AN EXCLUSIVITY CENTRAL PHARMACY THAT MAINTAINS A CENTRAL DATABASE U-1071 METHOD OF TREATING BLADDER DSYFUNCTION WITH ONCE A DAY TROSPIUM SALT FORMULATION U-1072 THE MANAGEMENT OF MODERATE TO SEVERE CHRONIC PAIN IN PATIENTS REQUIRING A CONTINUOUS, AROUND-THE-CLOCK OPIOID ANALGESIC FOR AN EXTENDED PERIOD OF TIME U-1073 USE FOR THE TREATMENT OF ASTHMA AND COPD

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PATENT AND EXCLUSIVITY TERMS

PATENT USE

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U-1074 USE OF EXENATIDE MAY RESULT IN REDUCTION IN BODY WEIGHT U-1075 USE FOR THE TREATMENT OF ASTHA U-1076 REDUCE CHRONIC SEVERE DROOLING (I.E., SIALORRHEA) IN PATIENTS WITH NEUROLOGIC CONDITIONS ASSOCIATED WITH PROBLEM DROOLING U-1077 PRETREATMENT OF PATIENTS WITH VITAMIN B12 AND FOLIC ACID PRIOR TO PEMETREXED DISODIUM ADMINISTRAION U-1078 TREATMENT OF ACNE U-1079 REVLIMID (LENALIDOMIDE) IS INDICATED FOR THE TREATMENT OF PATIENTS WITH TRANSFUSIONDEPENDENT ANEMIA IN MYELODYSPLASTIC SYNDROMES (MDS) U-1080 METHOD TO TREAT PULMONARY HYPERTENSION BY ADMINISTERING AMBRISENTAN TO A PATIENT U-1081 LUMIGAN IS A PROSTAGLANDIN ANALOG INDICATED FOR THE REDUCTION OF ELEVATED INTRAOCULAR PRESSURE IN PATIENTS WITH OPEN ANGLE GLAUCOMA OR OCULAR HYPERTENSION U-1082 USE OF A COMBINATION OF TOBRAMYCIN AND DEXAMETHASONE TO TREAT OCULAR INFLAMMATION WHERE AN INFECTION OR RISK OF INFECTION EXISTS U-1083 ACUTE TREATMENT OF MIGRAINE ATTACKS, WITH OR WITHOUT AURA, AND THE TREATMENT OF CLUSTER HEADACHE EPISODES U-1084 RELIEF OF THE INFLAMMATORY AND PRURITIC MANIFESTATIONS OF CORTICOSTEROID RESPONSIVE DERMATOSES IN PATIENTS 12 YEARS OF AGE OR OLDER U-1085 METHOD FOR TREATING IRRITABLE BOWEL SYNDROME AND METHOD FOR TREATING ABDOMINAL DISCOMFORT ASSOCIATED WITH IRRITABLE BOWEL SYNDROME U-1086 TREATMENT OF AUTOIMMUNE DISEASE U-1087 DETECTION OF NON-MUSCLE INVASIVE PAPILLARY CANCER OF THE BLADDER BY PHOTODYNAMIC CYSTOSCOPY U-1088 RELIEF OF MUSCLE SPASM U-1089 INHIBITION OF THROMBIN U-1090 LO LOESTRIN FE IS INDICATED FOR THE PREVENTION OF PREGNANCY IN WOMEN WHO ELECT TO USE ORAL CONTRACEPTIVES AS A METHOF OF CONTRACEPTION U-1091 ASSESSMENT OF BRONCHIAL HYPERRESPONSIVENESS IN PATIENTS 6 YEARS OF AGE OR OLDER WHO DO NOT HAVE CLINICALLY APPARENT ASTHMA U-1092 TREATMENT OF BREAST CANCER U-1093 TREATMENT OF PSEUDOBULBAR AFFECT U-1094 MANAGEMENT OF CHRONIC MUSCULOSKELETAL PAIN U-1095 METHOD OF TREATING OCULAR INFLAMMATION U-1096 TREATMENT OF PATIENTS WITH METASTATIC BREAST CANCER U-1097 ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS WHEN TREATMENT WITH BOTH SAXAGLIPTIN AND METFORMIN IS APPROPRIATE U-1098 METHOD OF TREATING HYPERPARATHYROIDISM; METHOD OF TREATING HYPERCALCEMIA U-1099 TREATMENT OF PAIN, INCLUDING NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY, POSTHERPETIC NEURALGIA, AND FIBROMYALGIA U-1100 REDUCTION OF EXCESS ABDOMINAL FAT IN HIV-INFECTED PATIENTS WITH LIPODYSTROPHY U-1101 METHOD OF TREATING EXCESSIVE DAYTIME SLEEPINESS IN PATIENTS WITH NARCOLEPSY U-1102 METHOD OF TREATING CATAPLEXY IN PATIENTS WITH NARCOLEPSY U-1103 TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE U-1104 USE OF TRAMADOL FOR THE MANAGEMENT OF MODERATE TO MODERATELY SEVERE CHRONIC PAIN U-1105 TOPICAL TREATMENT OF HEAD LICE INFESTATION IN PATIENTS FOUR (4) YEARS OF AGE AND OLDER U-1106 TREATING HYPERTRIGLYCERIDEMIAS WITH REDUCTION OF FOOD EFFECT U-1107 TREATING HYPERCHOLESTEROLEMIAS WITH REDUCTION OF FOOD EFFECT U-1108 TREATING TYPE 2 DIABETES MELLITUS WITH EXENATIDE BY STIMULATING INSULIN RELEASE U-1109 TREATMENT OF CUTANEOUS MANIFESTATIONS OF ERYTHEMA NODOSUM LEPROSUM (ENL) IN CONNECTION WITH A SPECIAL PROGRAM APPROVED BY FDA CALLED "SYSTEM FOR THALIDOMIDE EDUCATION AND PRESCRIBING SAFETY" (S.T.E.P.S.) U-1110 METHOD OF TREATING A PATIENT WITH A PRESCRIPTION DRUG USING A COMPUTER DATABASE IN A COMPUTER SYSTEM FOR DISTRIBUTION U-1111 NONSTEROIDAL ANTI-INFLAMMATORY DRUG INDICATED FOR RELIEF OF MILD TO MODERATE ACUTE PAIN U-1112 METHOD OF MR IMAGING OF A MAMMAL U-1113 TREATMENT AND PROPHYLAXIS OF INFLUENZA U-1114 TREATMENT WITH GABAPENTIN, INCLUDING TREATMENT OF NEUROPATHIC PAIN, INCLUDING NEUROPATHIC PAIN ASSOCIATED WITH POSTHERPETIC NEURALGIA U-1115 TREATMENT TO REDUCE THE RISK OF COPD EXACERBATIONS IN PATIENTS WITH SEVERE COPD ASSOCIATED WITH CHRONIC BRONCHITIS AND A HISTORY OF EXACERBATIONS U-1116 METHOD OF ADMINISTERING COLCHICINE TO FAMILIAL MEDITERRANEAN FEVER PATIENTS U-1117 TREATMENT OF BREAST CANCER U-1118 USE FOR THE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND EMPHYSEMA

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PATENT AND EXCLUSIVITY TERMS

PATENT USE

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U-1119 CONTRAST AGENT FOR MAGNETIC RESONANCE IMAGING U-1120 TO REDUCE GASTROINTESTINAL SIDE EFFECTS ADMINISTER WITH A MEAL; AS STARTING DOSE ADMINISTER ONCE DAILY WITH EVENING MEAL U-1121 METHOD OF TREATING TRAVELERS' DIARRHEA U-1122 TREATMENT OF SECONDARILY INFECTED TRAUMATIC SKIN LESIONS DUE TO S. AUREUS AND S. PYOGENES U-1123 TREATMENT OF ALCOHOL DEPENDENCE U-1124 PREVENTION OF RELAPSE TO OPIOID DEPENDENCE, FOLLOWING OPIOID DETOXIFICATION U-1125 METHOD FOR THE DETECTION OF NEUROENDOCRINE TUMORS U-1126 USE IN COMBINATION WITH PREDNISONE FOR THE TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER WHO HAVE RECEIVED PRIOR CHEMOTHERAPY CONTAINING DOCETAXEL U-1127 TREATMENT OF PATENT DUCTUS ARTERIOSUS U-1128 TREATMENT OF CHRONIC HEPATITIS C (CHC) GENOTYPE 1 INFECTION IN COMBINATION WITH PEGINTERFERON ALFA AND RIBAVIRIN IN ADULT PATIENTS (>=18 YEARS OF AGE) WITH COMPENSATED LIVER DISEASE U-1129 TREATMENT OF HYPERCHOLESTEROLEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT, WITH PRETREATMENT WITH A FLUSH INHIBITIN AGENT SUCH AS ASPIRIN U-1130 SECONDARY PREVENTION OF CARDIOVASCULAR EVENTS BY DOSING ONCE PER DAY IN THE EVENING OR A NIGHT WITH PRETREATMENT WITH A FLUSH INHIBITING AGENT SUCH AS ASPIRIN U-1131 TREATMENT OF HYPERTRIGLYDERIDEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT, WITH PRETREATMENT WITH A FLUSH INHIBITIN AGENT SUCH AS ASPIRIN U-1132 TREATMENT OF HYPERCHOLESTEROLEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT U-1133 SECONDARY PREVENTION OF CARDIOVASCULAR EVENTS BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT U-1134 TREATMENT OF HYPERTRIGLYCERIDEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT U-1135 TREATMENT OF HYPERCHOLESTEROLEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT, THROUGH REDUCTION OF LDL-C, TC, TG, LP(A) AND INCREASE OF HDL-C U-1136 SECONDARY PREVENTION OF CARDIOVASCULAR EVENTS BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT, THROUGH REDUCTION OF LDL-C, TC, TG, LP(A), AND INCREASE OF HDL-C U-1137 TREATMENT OF HYPERTRIGLYCERIDEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT, THROUGH REDUCTION OF LDL-C, TC, TG, LP(A), AND INCREASE OF HDL-C U-1138 TREATMENT OF PRIMARY AND MIXED DYSLIPIDEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT U-1139 REDUCTION IN RISK OF RECURRENT NONFATAL MYOCARDIAL INFARCTION BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT U-1140 REDUCTION IN ELEVATED TC AND LDL-C BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT U-1141 REDUCTION IN TG BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT U-1142 TREATMENT OF PRIMARY AND MIXED DYSLIPIDEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT, WITH PRETREATMENT WITH A FLUSH INHIBITING AGENT SUCH AS ASPIRIN U-1143 REDUCTION IN RISK OF RECURRENT NONFATAL MYOCARDIAL INFARCTION BY DOSING ONCE PER DAY IN THE EVENING OR A T NIGHT, WITH PRETREATMENT WITH A FLUSH INHIBITIN AGENT SUCH AS ASPIRIN U-1144 REDUCTION IN ELEVATED TC AND LDL-C BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT, WITH PRETREATMENT WITH A FLUSH INHIBITIN AGENT SUCH AS ASPIRIN U-1145 REDUCTION IN TG BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT, WITH PRETREATMENT WITH A FLUSH INHIBITING AGENT SUCH AS ASPIRIN U-1146 REDUCTION IN TG WITH REDUCED FLUSHING BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT U-1147 TREATMENT OF PRIMARY AND MIXED DYSLIPIDEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT, THROUGH REDUCTION OF LDL-C, TC, TG, LP(A), AND INCREASE OF HDL-C U-1148 REDUCTION IN RISK OF RECURRENT NONFATAL MYOCARDIAL INFARCTION BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT, THROUGH REDUCTINO OF LDL-C, TC, TG, LP(A), AND INCREASE OF HDL-C U-1149 TREATMENT OF HYPERTRIGLYCERIDEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT, WITH PRETREATMENT WITH A FLUSH INHIBITING AGENT SUCH AS ASPIRIN U-1150 TRETMENT OF HYPERCHOLESTEROLEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT, THROUGH REDUCTION IN TOTAL-C, LDL-C, TG, LP(A), AND INCREASE OF HDL-C U-1151 TREATMENT OF HYPERTRIGLYCDERIDEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT, THROUGH REDUCTION IN TOTAL-C, LDL-C, LP(A), AND INCREASE OF HDL-C U-1152 CYANOCOBALAMIN ADMINISTRATION THROUGH NASAL INFUSION U-1153 IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS, IS INDICATED FOR THE TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) INFECTION IN ANTIRETROVIRAL TREATMENT-NAIVE ADULT PATIENTS, AS SET FORTH IN THE LABELING, INCLUDING I&U SECTION U-1154 TREATMENT OF PROTEIN KINASE RELATED DISORDERS, SUCH AS GASTROINTESTINAL STROMAL TUMORS, RENAL CELL CARCINOMA AND ADVANCED PANCREATIC NEUROENDOCRINE TUMORS, WITH SUNITINIB U-1155 USE OF THALIDOMIDE IN TREATMENT OF CUTANEOUS MANIFESTATIONS OF ERYTHEMA NODOSUM LEPROSUM (ENL) U-1156 TO REDUCE BLOOD PHENYLALANINE (PHE) LEVELS IN PATINETS WITH HYPERPHENYLALANINEMIA (HPA)

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PATENT AND EXCLUSIVITY TERMS

PATENT USE

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U-1157 RELIEF OF SYMPTOMS ASSOCIATED WITH RESPIRATORY ALLERGIES IN ADULTS AND CHILDREN 2 YEARS OF AGE AND OLDER AND FOR THE RELIEF OF SYMPTOMS ASSOCIATED WITH HIVES (URTICARIA) IN ADULTS AND CHILDREN 6 YEARS OF AGE AND OLDER U-1158 RELIEF OF SYMPTOMS ASSOCIATED WITH RESPIRATORY ALLERGIES AND FOR THE RELIEF OF SYMPTOMS ASSOCIATED WITH HIVES (URTICARIA) IN ADULTS AND CHILDREN 6 YEARS OF AGE AND OLDER U-1159 RELIEF OF SYMPTOMS ASSOCIATED WITH RESPIRATORY ALLERGIES, SWELLING OF THE NASAL PASSAGES AND SINUS CONGESTION AND PRESSURE IN ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER U-1160 RELIEF OF SYMPTOMS ASSOCIATED WITH RESPIRATORY ALLERGIES AND FOR THE RELIEF OF SYMPTOMS ASSOCIATED WITH HIVES (URTICARIA) IN ADULTS AND CHILDREN 6 YEARS OF AGE AND OLDER AND 12 YEARS OF AGE AND OLDER U-1161 FOR THE TREATMENT AND PROPHYLAXIS OF GOUT FLARES & THE TREATMENT OF FAMILIAL MEDITERRANEAN FEVER U-1162 TREATMENT OF SEBORRHEIC DERMATITIS OF THE SCALP U-1163 METHOD OF TREATING THROMBOSIS U-1164 METHOD OF TREATING AN ARGATROBAN TREATABLE CONDITION U-1165 USE FOR THE TREATMENT OF MULTIPLE MYELOMA U-1166 A METHOD FOR TREATMENT OF GOUT FLARES DURING PROPHYLAXIS U-1167 PROPHYLAXIS OF DEEP VEIN THROMBOSIS (DVT) U-1168 THE LONG TERM, ONCE-DAILY MAINTENANCE BROCHODILATOR TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA U-1169 MANAGEMENT OF BREAKTHROUGH PAIN IN CANCER PATIENTS 18 YEARS OF AGE AND OLDER WHO ARE RECEIVING AND TOLERANT TO OPIOID THERAPY FOR THEIR UNDERLYING PERSISTENT CANCER PAIN U-1170 TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER U-1171 REDUCTION OF THE RATE OF THROMBOTIC EVENTS IN PATIENTS WITH ACUTE CORONARY SYNDROME U-1172 TO REDUCE ELEVATED TOTAL-C, APO B, AND NON-HDL-C IN PATIENTS WIHT PRIMARY HYPERLIPIDEMIA BY ADMINISTRATION OF EZETIMIBE IN COMBINATION WITH A STATIN U-1173 TO REDUCE ELEVATED TOTAL-C, LDL-C, APO B AND NON-HDL-C IN PATIENTS WITH PRIMARY HYPERLIPIDEMIA BY ADMINISTRATION OF EZETIMIBE ALONE OR IN COMBINATION WITH A STATIN OR WITH FENOFIBRATE U-1174 ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE WATER FOR INJECTION, 0.9% SODIUM CHLORIDE INJECTION, OR FLOLAN STERIILE DILUENT FOR INJECTION PRIOR TO ADMINISTRATION U-1175 REDUCTION OF CARDIAC TISSUE DAMAGE ASSOCIATED WITH MYOCARDIAL INFARCTION U-1176 TREATMENT OR PREVENTION OF STROKE U-1177 REDUCTION OF CARDIAC TISSUE DAMAGE ASSOCIATED WITH MYOCARDIAL INFARCTION U-1178 RELIEF OF MODERATE TO SEVERE CHRONIC PAIN U-1179 TREATMENT OF A CANCER MEDIATED BY AN ANAPLASTIC LYMPHOMA KINASE (ALK) U-1180 TREATMENT OF THE FOLLOWING INFECTIONS: COMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS AND STAPHYLOCOCCUS AUREUS BLOODSTREAM INFECTIONS (BACTEREMIA) INCLUDING THOSE WITH RIGHTSIDED INFECTIVE ENDOCARDITIS U-1181 A METHOD OF TREATING OR PREVENTING OCULAR PAIN IN A PATIENT U-1182 TREATMENT OF CYCLIC HEAVY MENSTRUAL BLEEDING U-1183 A METHOD FOR ADMINISTERING FOLLICLE STIMULATING HORMONE (FSH) FOR OVARIAN FOLLICLE OR TESTICULAR STIMULATION IN THE HUMAN U-1184 TREATMENT OF ERECTILE DYSFUNCTION AND THE SIGNS AND SYMPTOMS OF BENIGN PROSTATIC HYPERPLASIA U-1185 TREATMENT OF OPIOID-INDUCED CONSTIPATION U-1186 ADMINISTRATION OF AN INHALABLE POWDER COMPRISING TIOTROPIUM VIA DEVICE U-1187 TREATMENT OF PATHOLOGICAL STATE BY ANTAGONIZING BRADYKININ RECEPTOR INCLUDING TREATMENT OF ACUTE ATTACKS OF HEREDITARY ANGIOEDEMA (HAE) U-1188 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE U-1189 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH METFORMIN U-1190 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH INSULIN U-1191 METHOD OF TX TYPE 2 DM IN PTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBO WITH AN AGENT ACTING ON AN ATP-DEPENDENT CHANNEL IN BETA CELLS SUCH AS A SULFYONYLUREA(INCL GLIPIZIDE, GLIMEPIRIIDE & GLYBURIDE) U-1192 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH A SULFONYLUREA (SUCH AS GLIPIZIDE, GLIMEPIRIDE AND GLYBURIDE) U-1193 METHOD OF TREATING TYPE 2 DIABETES MELITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH A PPAR-GAMMA AGONIST (SUCH AS PIOGLITAZONE AND ROSIGLITAZONE) U-1194 METHOD FOR TREATING INSOMNIA

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PATENT AND EXCLUSIVITY TERMS

PATENT USE

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U-1195 PREVENTION AND TREATMENT OF SECONDARY HYPERPARATHYROIDISM ASSOCIATED WITH CHRONIC KIDNEY DISEASE (CKD) STAGE 5, WHICH MAY RESULT IN RENAL OSTEODYSTROPHY, WHILE AVOIDING HYPERPHOSPHATEMIA U-1196 RELIEF OF SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS AND OSTEOARTHRITIS AND TO DECREASE RISK OF DEVELOPING UPPER GASTROINTESTINAL ULCERS IN PATIENTS WHO ARE TAKING IBUPROFEN FOR THOSE INDICATIONS U-1197 METHOD OF TREATMENT OF CHILDREN WITH CENTRAL PRECOCIOUS PUBERTY U-1198 RECTIV IS A NITRATE VASODILATOR INDICATED FOR THE TREATMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH CHRONIC ANAL FISSURE U-1199 TREATMENT AND PREVENTION OF POSTMENOPAUSAL OR GLUCOCORTICOID-INDUCED OSTEOPOROSIS AND TREATMENT TO INCREASE BONE MASS IN MEN WITH OSTEOPOROSIS U-1200 REDUCING THE RISK OF STROKE AND SYSTEMIC EMBOLISM U-1201 FOR THE TREATMENT OF INTERMEDIATE OR HIGH-RISK MYELOFIBROSIS U-1202 METHOD FOR RELIEVING OR TREATING CONSTIPATION IN A PATIENT WITH IRRITABLE BOWEL SYNDROME U-1203 METHOD FOR RELIEVING OR TREATING CONSTIPATION IN A HUMAN CONSTIPATED PATIENT U-1204 TREATMENT OF UVEITIS U-1205 TREATMENT OF MACULAR EDEMA U-1206 DELIVERING AN OCULAR IMPLANT AS DESCRIBED IN THE DOSAGE AND ADMINISTRATION SECTION OF THE APPROVED LABELING OF OZURDEX U-1207 INFANT USE AGED 1 MONTH TO LESS THAN ONE YEAR, GERD AND EROSIVE ESOPHAGITIS U-1208 TREATMENT OF HYPOTRICHOSIS OF THE EYELASHES BY INCREASING THEIR GROWTH INCLUDING LENGTH, THICKNESS AND DARKNESS