FDA Drug Directory Sep 03

PRODUCTID PRODUCTNDC PRODUCTTYPENAME PROPRIETARYNAME PROPRIETARYNAMES
UFFIX NONPROPRIETARYNAME DOSAGEFORMNAME ROUTENAME STARTMARKETINGDA

TE ENDMARKETINGDATE MARKETINGCATEGORYNAME APPLICATIONNUMBER
LABELERNAME SUBSTANCENAME ACTIVE_NUMERATOR_STRENGTH ACTIVE_INGRED_UN
IT PHARM_CLASSES DEASCHEDULE
10202-085_f3b7863e-bd27-4e16-a16c-04e44bd16055 10202-085 HUMAN OTC DRUG
7-11 Instant Hand Sanitizer With Aloe And Vitamin E ALCOHOL LIQUID
TOPICAL 20111102 OTC MONOGRAPH NOT FINAL part333E 11-Jul
ALCOHOL 62 mL/100mL
51393-6989_b68f11b6-d10c-48ea-aea3-a6cf258088f2 51393-6989 HUMAN OTC DRUG
Nail Fungus Control Extra Strength "Calendula Officinalis Flowering Top, Si
licon Dioxide, and Hypericum Perforatum" SOLUTION/ DROPS TOPICAL 20110406
UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FL
OWERING TOP; HYPERICUM PERFORATUM; SILICON DIOXIDE 8; 8; 8 [hp_X]/1000mL; [
hp_X]/1000mL; [hp_X]/1000mL
62864-901_d8abada4-8cf0-4e30-aa10-9f14fde0f1a7 62864-901 HUMAN OTC DRUG
ARRID XX Roll On Antiperspirant Deodorant Regular Aluminum Chloroh
ydrate LIQUID TOPICAL 19960716 OTC MONOGRAPH FINAL part350
.Church & Dwight Canada Corp ALUMINUM CHLOROHYDRATE 16 mL/100mL
0869-0218_6325f77f-f6d6-4dfd-ac77-05bdacdb2722 0869-0218 HUMAN OTC DRUG
Clear Anti Itch "Pramoxine HCl, Zinc acetate" LOTION TOPICAL 19940507
OTC MONOGRAPH FINAL part347 /Vi-Jon PRAMOXINE HYDROCHLORIDE; ZINC ACETATE
10; 1 mg/mL; mg/mL
43319-010_ea8004a1-63df-424c-9523-9ea016768aee 43319-010 HUMAN OTC DRUG
GOONGSECRET BABY SUN SPF35 PA PLUS PLUS PLUS "ZINC OXIDE, TITANIUM DIOXIDE"
LOTION TOPICAL 20120301 OTC MONOGRAPH FINAL part352 0to7 Inc
TITANIUM DIOXIDE; ZINC OXIDE 5.632; 9.216 g/80g; g/80g
43319-020_42d12822-4dea-4fca-9361-f22a970520de 43319-020 HUMAN OTC DRUG
GOONGSECRET DAILY FACE SUN SPF25 PA PLUS PLUS TITANIUM DIOXIDE
CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part352 0to7 Inc
TITANIUM DIOXIDE 2.886 g/60g
43319-030_a1dfba7b-792b-4bad-bf81-a2b6e5c0c12c 43319-030 HUMAN OTC DRUG
GOONGSECRET CALMING BATH ALLANTOIN POWDER TOPICAL 20120301
OTC MONOGRAPH FINAL part347 0to7 Inc ALLANTOIN 0.055 g/10g
43319-040_eb9c4e46-c7c8-4f0e-bb3f-b004399d0aa5 43319-040 HUMAN OTC DRUG
GOONGSECRET HANDS CLEAN ALCOHOL GEL TOPICAL 20120301
OTC MONOGRAPH NOT FINAL part333E 0to7 Inc ALCOHOL 46.5 mL/75mL
43319-050_896233e7-0882-4b17-91e0-c1b4c41850c4 43319-050 HUMAN OTC DRUG
GOONG SECRET MILD SUN SPF25 PA PLUS PLUS "Zinc Oxide, Titanium Dioxide"
CREAM TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 0to7 Inc
TITANIUM DIOXIDE; ZINC OXIDE 1.98; 2.82 mg/60mL; mg/60mL
43319-060_865d3db4-dce2-4018-8bba-cb1e0b88e7d1 43319-060 HUMAN OTC DRUG
GOONG SECRET CALMING BATH Allantoin POWDER TOPICAL 20130201
OTC MONOGRAPH FINAL part347 0to7 Inc ALLANTOIN 0.44 mg/80mL
43319-070_6b05da48-f723-4f72-94ed-d264e904ceaf 43319-070 HUMAN OTC DRUG
Goongsecret Mild Sun SPF25 PA PLUS PLUS "Zinc Oxide, Titanium Dioxide"
CREAM TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 0to7 Inc
TITANIUM DIOXIDE; ZINC OXIDE 1.98; 2.82 mg/60mL; mg/60mL
43319-080_e71bffd4-d907-47db-900b-dceb8a463986 43319-080 HUMAN OTC DRUG
Goongsecret Calming Bath Oriental Formula for Babies Sodium Bicarbona
te POWDER TOPICAL 20130701 OTC MONOGRAPH FINAL part347
0to7 Inc SODIUM BICARBONATE 165 g/300g
59276-209_71cf7fd2-76b4-4d0a-8150-6fb274f8db69 59276-209 HUMAN OTC DRUG
A-Med brand First Aid Eye and Skin-Rinse Purified Water SOLUTION
CUTANEOUS; OPHTHALMIC; TOPICAL 20131101 OTC MONOGRAPH FINAL
part349 1602041 Ontario Limited WATER 98.577 mL/100mL
44099-001_5697b8cf-7d03-4f97-b7f6-b3bd926f20f9 44099-001 HUMAN OTC DRUG
skin MD Natural "octinoxate, octisalate, homosalate" LOTION TOPICAL
20080819 OTC MONOGRAPH NOT FINAL part352 21st Century Formulation
s HOMOSALATE; OCTINOXATE; OCTISALATE 3; 7; 5 mg/100mL; mg/100mL; mg/1
00mL
63972-002_369ec9a7-1d45-4010-86b2-8098a2dad2b3 63972-002 HUMAN OTC DRUG
CENTURY 21 LYMPHATIC DRAINAGE "STRYCHNOS NUX-VOMICA SEED, BARIUM CHLOR
IDE DIHYDRATE, LACHESIS MUTA VENOM, CONIUM MACULATUM FLOWERING TOP, GOLDENSEAL,
IODINE, SILICON DIOXIDE, PHOSPHORUS, QUININE SULFATE, SILYBUM MARIANUM SEED, CHE
LIDONIUM MAJUS, BERBERIS VULGARIS ROOT BARK, SONIA CANADENSIS ROOT, MERCURIUS SO
LUBILIS, CEANOTHUS AMERICANUS LEAF, SOLIDAGO VIRGAUREA FLOWERING TOP, BOS TAURUS
BILE, APIS MELLIFERA" LIQUID ORAL 19750101 UNAPPROVED HOMEO
PATHIC "21st Century Homeopathics, Inc" APIS MELLIFERA; BARIUM C
HLORIDE DIHYDRATE; BERBERIS VULGARIS ROOT BARK; BOS TAURUS BILE; CEANOTHUS AMERI
CANUS LEAF; CHELIDONIUM MAJUS; COLLINSONIA CANADENSIS ROOT; CONIUM MACULATUM FLO
WERING TOP; GOLDENSEAL; IODINE; LACHESIS MUTA VENOM; MERCURIUS SOLUBILIS; PHOSPH
ORUS; QUININE SULFATE; SILICON DIOXIDE; SILYBUM MARIANUM SEED; SOLIDAGO VIRGAURE
A FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED 30; 30; 30; 6; 30; 30; 30; 30; 3
0; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_
C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL;
[hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5
mL; [hp_C]/5mL
63972-003_61c2f388-041b-448a-b66a-b30f1364fce6 63972-003 HUMAN OTC DRUG
CENTURY 21 ACUTE STRESS "ARNICA MONTANA, ARSENIC TRIOXIDE, BELLIS PERENN
IS, PASSIFLORA INCARNATA FLOWERING TOP, VALERIAN, APIS MELLIFERA, HUMAN BREAST T
UMOR CELL, HELIANTHEMUM CANADENSE, CLEMATIS RECTA FLOWERING TOP, ARABICA COFFEE
BEAN, STRYCHNOS IGNATII SEED, LACHESIS MUTA VENOM, MAGNESIUM PHOSPHATE, DIBASIC
TRIHYDRATE, SODIUM CHLORIDE, SODIUM SULFATE, ORNITHOGALUM UMBELLATUM, PHOSPHORIC
ACID, SALIX NIGRA BARK, DELPHINIUM STAPHISAGRIA SEED" LIQUID ORAL 19750101
UNAPPROVED HOMEOPATHIC "21st Century Homeopathics, Inc" "APIS ME
LLIFERA; ARABICA COFFEE BEAN; ARNICA MONTANA; ARSENIC TRIOXIDE; BELLIS PERENNIS;
CLEMATIS RECTA FLOWERING TOP; DELPHINIUM STAPHISAGRIA SEED; HELIANTHEMUM CANADE
NSE; HUMAN BREAST TUMOR CELL; LACHESIS MUTA VENOM; MAGNESIUM PHOSPHATE, DIBASIC
TRIHYDRATE; ORNITHOGALUM UMBELLATUM; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHO
RIC ACID; SALIX NIGRA BARK; SODIUM CHLORIDE; SODIUM SULFATE; STRYCHNOS IGNATII S
EED; VALERIAN" 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30;
30; 30; 30 [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_
C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL;
mL
63972-004_64baaa23-56a2-4689-bfa0-a2c44f4b23ff 63972-004 HUMAN OTC DRUG
CENTURY 21 DETOX-VIRUS "ARANEUS DIADEMATUS, RANCID BEEF, PHYTOLACCA AME
RICANA ROOT, ECHINACEA ANGUSTIFOLIA, ASTRAGALUS PROPINQUUS ROOT, BAPTISIA TINCTO
RIA ROOT, GOLDENSEAL, LACHESIS MUTA VENOM, GELSEMIUM SEMPERVIRENS ROOT, ATROPA B
ELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, ARSENIC TRIOXIDE, SILICON DIOXI
DE, THUJA OCCIDENTALIS LEAFY TWIG, BILBERRY, APIS MELLIFERA" LIQUID ORAL
19750101 UNAPPROVED HOMEOPATHIC "21st Century Homeopathi
cs, Inc" APIS MELLIFERA; ARANEUS DIADEMATUS; ARSENIC TRIOXIDE; ASTRAGALUS
PROPINQUUS ROOT; ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; BILBERRY; ECHINACE
A ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROO
T; GOLDENSEAL; LACHESIS MUTA VENOM; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT;
RANCID BEEF; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAFY TWIG 30; 30; 30; 30;
30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/5mL; [hp_C]/5mL;
mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_
C]/5mL; [hp_C]/5mL
63972-005_f0cc7f75-8737-4e59-9948-caabb98a62f2 63972-005 HUMAN OTC DRUG
CENTURY 21 CHRONIC STRESS "AMERICAN GINSENG, GOLDENSEAL, CEANOTHUS
AMERICANUS LEAF, ACTIVATED CHARCOAL, OYSTER SHELL CALCIUM CARBONATE, CRUDE, SOD
IUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, SOLIDAGO VIRGAUREA FLOWERING TOP, CYCLA
MEN PURPURASCENS TUBER, TARAXACUM OFFICINALE ROOT, ARSENIC TRIOXIDE, PHOSPHORUS,
CALCIUM SULFIDE, TRIFOLIUM PRATENSE FLOWER, KEROSENE, FUCUS VESICULOSUS"
LIQUID ORAL 19750101 UNAPPROVED HOMEOPATHIC "21st Ce
ntury Homeopathics, Inc" "ACTIVATED CHARCOAL; AMERICAN GINSENG; ARSENIC T
RIOXIDE; CALCIUM SULFIDE; CEANOTHUS AMERICANUS LEAF; CYCLAMEN PURPURASCENS TUBER
; FUCUS VESICULOSUS; GOLDENSEAL; KEROSENE; OYSTER SHELL CALCIUM CARBONATE, CRUDE
; PHOSPHORUS; SODIUM CHLORIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-V
OMICA SEED; TARAXACUM OFFICINALE ROOT; TRIFOLIUM PRATENSE FLOWER" 30; 30;
30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/5mL; [hp_C]/5mL;
C]/5mL
63972-006_cf397737-b571-432a-9763-3127a98f1276 63972-006 HUMAN OTC DRUG
CENTURY 21 ENVIROMENTAL DETOX "CORTICOTROPIN, OYSTER SHELL CALCIUM CAR
BONATE, CRUDE, MAGNESIUM SULFATE HEPTAHYDRATE, POTASSIUM PHOSPHATE, DIBASIC, NIT
RIC ACID, BENZOIC ACID, SILICON DIOXIDE, ARSENIC TRIOXIDE, MERCURIUS SOLUBILIS,
PHOSPHORUS, ACTIVATED CHARCOAL, STRYCHNOS NUX-VOMICA SEED, ALUMINUM, PHYTOLACCA
AMERICANA ROOT, BAPTISIA TINCTORIA ROOT, SILVER NITRATE, SPIGELIA ANTHELMIA, API
S MELLIFERA" LIQUID ORAL 19750101 UNAPPROVED HOMEOPATHIC
"21st Century Homeopathics, Inc" "ACTIVATED CHARCOAL; ALUMINUM; APIS MELL
IFERA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BENZOIC ACID; CORTICOTROPIN; M
AGNESIUM SULFATE HEPTAHYDRATE; MERCURIUS SOLUBILIS; NITRIC ACID; OYSTER SHELL CA
LCIUM CARBONATE, CRUDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; POTASSIUM PHOSPHA
TE, DIBASIC; SILICON DIOXIDE; SILVER NITRATE; SPIGELIA ANTHELMIA; STRYCHNOS NUX-
VOMICA SEED" 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30;
30; 30 [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL;
mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL
63972-007_c73f0f05-dfb8-4134-baf7-f08eaad29942 63972-007 HUMAN OTC DRUG
CENTURY 21 HEAVY METAL DETOX "GARLIC, GOLD, ATROPA BELLADONNA, BERBER
IS VULGARIS ROOT BARK, CAUSTICUM, CONIUM MACULATUM FLOWERING TOP, CALCIUM SULFID
E, HYPERICUM PERFORATUM, IPECAC, ALUMINUM, SILVER, ARSENIC, BARIUM CARBONATE, BE
RYLLIUM, BORON, BROMINE, CADMIUM, D and C BLACK NO. 2, CERIUM, CESIUM, CHROMIUM,
COBALT, COPPER, DYSPROSIUM, ERBIUM, EUROPIUM, IRON, FLUORINE, GADOLINIUM, GALLI
UM, GERMANIUM, HOLMIUM, HYDROGEN, INDIUM, IODINE, LANTHANUM, LITHIUM CARBONATE,
MANGANESE, MERCURIUS SOLUBILIS, MOLYBDENUM, NEODYMIUM, NICKEL" LIQUID ORAL
19750101 UNAPPROVED HOMEOPATHIC "21st Century Homeopathi
cs, Inc" ALUMINUM; APIS MELLIFERA; ARSENIC; ATROPA BELLADONNA; BARIUM CAR
BONATE; BERBERIS VULGARIS ROOT BARK; BERYLLIUM; BORON; BROMINE; CADMIUM; CALCIUM
SULFIDE; CAUSTICUM; CERIUM; CESIUM; CHROMIUM; COBALT; CONIUM MACULATUM FLOWERIN
G TOP; COPPER; D&C BLACK NO. 2; DYSPROSIUM; ERBIUM; EUROPIUM; FLUORINE; GADOLINI
UM; GALLIUM; GARLIC; GERMANIUM; GOLD; HOLMIUM; HYDROGEN; HYPERICUM PERFORATUM; I
NDIUM; IODINE; IPECAC; IRON; LANTHANUM; LEAD; LITHIUM CARBONATE; MANGANESE; MERC
URIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM; NICKEL; NIOBIUM; NITROUS OXIDE; OXYGEN;
PRASEODYMIUM; RUBIDIUM; SAMARIUM; SCANDIUM; SELENIUM; SILICON DIOXIDE; SILVER; S
TRONTIUM CARBONATE; TANTALUM; TERBIUM; THULIUM; TIN; TITANIUM; VANADIUM; VERATRU
M ALBUM ROOT; YTTERBIUM; ZINC 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30;
30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30;
30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30;
30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/5mL; [hp_C]/5mL; [hp_X]/5
mL; [hp_C]/5mL; [hp_X]/5mL; [hp_C]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_
X]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL;
[hp_C]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5
mL; [hp_X]/5mL; [hp_X]/5mL; [hp_C]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_
X]/5mL; [hp_C]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_C]/5mL; [hp_X]/5mL; [hp_X]/5mL;
[hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5
mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_
X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL;
[hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_C]/5mL; [hp_X]/5mL; [hp_X]/5
mL
63972-008_0dcd995f-444a-4daf-9f96-fde8b3d6ce6b 63972-008 HUMAN OTC DRUG
CENTURY 21 FUNGAL YEAST INFECTION "CANDIDA ALBICANS, SEPIA OFFICIN
ALIS JUICE, ECHINACEA, UNSPECIFIED, LYCOPODIUM CLAVATUM SPORE, PULSATILLA VULGAR
IS, THUJA OCCIDENTALIS LEAFY TWIG, OYSTER SHELL CALCIUM CARBONATE, CRUDE, ASTRAG
ALUS PROPINQUUS ROOT, MERCURIUS SOLUBILIS, GOLDENSEAL, PHYTOLACCA AMERICANA ROOT
, BERBERIS VULGARIS ROOT BARK, GENTIANA LUTEA ROOT, APIS MELLIFERA" LIQUID
ORAL 19750101 UNAPPROVED HOMEOPATHIC "21st Century Ho
meopathics, Inc" "APIS MELLIFERA; ASTRAGALUS PROPINQUUS ROOT; BERBERIS VU
LGARIS ROOT BARK; CANDIDA ALBICANS; ECHINACEA, UNSPECIFIED; GENTIANA LUTEA ROOT;
GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; OYSTER SHELL CALCIU
M CARBONATE, CRUDE; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; SEPIA OFFICI
NALIS JUICE; THUJA OCCIDENTALIS LEAFY TWIG" 30; 30; 30; 30; 30; 30; 30; 30;
30; 30; 30; 30; 30; 30 [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_X]/5mL; [hp_C]/5
C]/5mL; [hp_C]/5mL; [hp_C]/5mL
63972-009_acd58147-7ff9-4115-91f8-581c31f124c6 63972-009 HUMAN OTC DRUG
CENTURY 21 BACTERIAL DETOX "ECHINACEA ANGUSTIFOLIA, BAPTISIA TINCTO
RIA ROOT, PHYTOLACCA AMERICANA ROOT, FERROSOFERRIC PHOSPHATE, ARSENIC TRIOXIDE,
ATROPA BELLADONNA, MATRICARIA RECUTITA, MERCURIUS SOLUBILIS, GELSEMIUM SEMPERVIR
ENS ROOT, LACHESIS MUTA VENOM, SOLANUM DULCAMARA TOP, RANCID BEEF, GARLIC, APIS
MELLIFERA" LIQUID ORAL 19750101 UNAPPROVED HOMEOPATHIC
"21st Century Homeopathics, Inc" APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA
BELLADONNA; BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; FERROSOFERRIC PHOS
PHATE; GARLIC; GELSEMIUM SEMPERVIRENS ROOT; LACHESIS MUTA VENOM; MATRICARIA RECU
TITA; MERCURIUS SOLUBILIS; PHYTOLACCA AMERICANA ROOT; RANCID BEEF; SOLANUM DULCA
MARA TOP 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/5
C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL
63972-010_d73a2dde-72de-4cca-801d-84a40ed5fbee 63972-010 HUMAN OTC DRUG
CENTURY 21 PARASITE DETOX "BARIUM CARBONATE, OYSTER SHELL CALCIUM
CARBONATE, CRUDE, SILYBUM MARIANUM SEED, CHELIDONIUM MAJUS, ARTEMISIA MARITIMA F
LOWER, FERRIC CHLORIDE HEXAHYDRATE, SODIUM CHLORIDE, SCHOENOCAULON OFFICINALE SE
ED, SILICON DIOXIDE, SPIGELIA ANTHELMIA, SULFUR, THYROID, UNSPECIFIED, APIS MELL
IFERA, TURPENTINE OIL, TEUCRIUM MARUM" LIQUID ORAL 19750101
UNAPPROVED HOMEOPATHIC "21st Century Homeopathics, Inc" "APIS ME
LLIFERA; ARTEMISIA MARITIMA FLOWER; BARIUM CARBONATE; CHELIDONIUM MAJUS; FERRIC
CHLORIDE HEXAHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SCHOENOCAULON OFFIC
INALE SEED; SILICON DIOXIDE; SILYBUM MARIANUM SEED; SODIUM CHLORIDE; SPIGELIA AN
THELMIA; SULFUR; TEUCRIUM MARUM; THYROID, UNSPECIFIED; TURPENTINE OIL" 30; 30;
30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 6; 5 [hp_C]/5mL; [hp_C]/5mL;
mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_X]/5mL; [hp_X]/5mL
57367-001_4551f41d-c0e3-485e-950b-9014633e75e7 57367-001 HUMAN OTC DRUG
GIGI ANESTHETIC NUMBING LIDOCAINE AEROSOL TOPICAL 19971027
OTC MONOGRAPH FINAL part348 220 LABORATORIES INC LIDOCAINE 40
mg/g
57367-007_f82e9fcf-7441-4beb-8f64-79b6b8ee5061 57367-007 HUMAN OTC DRUG
NICK RELIEF ALUMINUM SULFATE STICK TOPICAL 19971127
OTC MONOGRAPH FINAL part347 220 LABORATORIES INC ALUMINUM SULFATE
46 mg/mL
57367-008_2f75fe11-48b7-4221-a4ee-5195ca7832d8 57367-008 HUMAN OTC DRUG
Anti-Perspirant Deodorant ALUMINUM CATION STICK TOPICAL 20100525
OTC MONOGRAPH FINAL part350 220 Laboratories Inc ALUMINUM CHLOROHYDRATE
52 mg/g
57367-029_b0602558-795b-4916-b143-74d0e6e6a84c 57367-029 HUMAN OTC DRUG
SUNSCREEN WATER RESISTANT HOMOSALATE OXYBENZONE OCTISALATE AVOBENZONE OCTY
LCRYLENE "AEROSOL, SPRAY" TOPICAL 20100510 OTC MONO
GRAPH NOT FINAL part352 220 Laboratories Inc AVOBENZONE; HOMOSALATE; OCTISALA
TE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 20; 50 mg/g; mg/g; mg/g; mg/g;
mg/g
57367-033_3cc1078d-c61a-4b3c-877f-e0cbb6e7b9e7 57367-033 HUMAN OTC DRUG
THERABREATH TOOTHPASTE SODIUM FLUORIDE "GEL, DENTIFRICE" DENTAL
20100303 OTC MONOGRAPH FINAL part355 220 LABORATORIES INC
SODIUM FLUORIDE 24 mg/10g
57367-027_de535765-6fa3-4715-9dcc-037f6dc80577 57367-027 HUMAN OTC DRUG
DAY HYDRATOR SPF-15 OCTINOXATE and OCTISALATE and OXYBENZONE LOTION
TOPICAL 20060201 OTC MONOGRAPH NOT FINAL part352 220 Laboratories
Inc. OCTINOXATE; OCTISALATE; OXYBENZONE 75; 50; 30 mg/g; mg/g; mg/g
24663-000_e74801d8-0dc5-47f1-bb3a-5ed4677bf3ae 24663-000 HUMAN OTC DRUG
29 by LYDIA MONDAVI Napa Valley BROAD SPECTRUM SPF 30 D VINE DAY
"AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE" CREAM TOPICAL
20131016 OTC MONOGRAPH NOT FINAL part352 "29 Luxury Goods, Inc."
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 20;
25 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL
76159-001_84374af4-c328-4bc7-987c-ddb2c027de69 76159-001 HUMAN OTC DRUG
3LAB PERFECT BB SPF 40 Broad Spectrum 01 TITANIUM DIOXIDE
CREAM TOPICAL 20130110 OTC MONOGRAPH FINAL part352 "3LAB, I
nc" TITANIUM DIOXIDE 121.6 mg/mL
76159-002_633a9c4a-6527-4794-9ed9-5c51fdf80eb7 76159-002 HUMAN OTC DRUG
76159-003_e6a36d6e-3a91-4d30-993e-182c406037a1 76159-003 HUMAN OTC DRUG
76159-124_83d7b0fa-f63d-4b3f-9b09-14bd918a4499 76159-124 HUMAN OTC DRUG
3LAB Hydra Day SPF 20 Broad Spectrum Water-Based Sunscreen "OCTINOX
ATE, OCTISALATE, AVOBENZONE" CREAM TOPICAL 20121015 OTC MONO
GRAPH FINAL part352 "3LAB, Inc" AVOBENZONE; OCTINOXATE; OCTISALATE
2; 75; 46 mg/mL; mg/mL; mg/mL
76159-234_bfcebd50-7c6b-467f-a563-4b3c76ac06bb 76159-234 HUMAN OTC DRUG
3LAB PERFECT Lite Sunscreen SPF 30 Broad Spectrum "TITANIUM DIOXID
E, ZINC OXIDE" CREAM TOPICAL 20110415 OTC MONOGRAPH FINAL
part352 "3LAB, Inc" TITANIUM DIOXIDE; ZINC OXIDE 24.8; 60 mg/mL; m
g/mL
76159-345_a95cbdf5-16b6-44b1-8c34-032c80019703 76159-345 HUMAN OTC DRUG
3LAB PERFECT Sunscreen SPF 50 Plus Broad Spectrum "HOMOSALATE, OCT
ISALATE, AVOBENZONE, OCTOCRYLENE" CREAM TOPICAL 20110421
OTC MONOGRAPH FINAL part352 "3LAB, Inc" AVOBENZONE; HOMOSALATE; OCTISALA
TE; OCTOCRYLENE 30; 100; 50; 26 mg/mL; mg/mL; mg/mL; mg/mL
76159-004_da16efaf-dbca-481e-b594-9b8677968ff8 76159-004 HUMAN OTC DRUG
3LAB Aqua BB SPF 40 BROAD SPECTRUM 01 TITANIUM DIOXIDE CREAM
TOPICAL 20131118 OTC MONOGRAPH NOT FINAL part352 "3LAB, Inc."
TITANIUM DIOXIDE 78.6 mg/mL
76159-005_314ce73c-4d8b-4ffb-8f14-8df268468faf 76159-005 HUMAN OTC DRUG
76159-006_d3536448-ece4-41db-9795-c4abbf4895a0 76159-006 HUMAN OTC DRUG
17518-054_993cbe8c-adc5-41be-bfec-e5cdd44319ca 17518-054 HUMAN OTC DRUG
3M Nexcare Cold Sore Treatment 3M Nexcare Cold Sore Treatment OINTMENT
TOPICAL 20080220 OTC MONOGRAPH NOT FINAL part348 3M Company
ALLANTOIN; BENZOCAINE 10; 50 mg/g; mg/g
48878-0231_bfcdb6b4-85a4-485f-a2ce-3465e3a72953 48878-0231 HUMAN OTC DRUG
Avagard D alcohol LOTION TOPICAL 19991001 OTC MONO
GRAPH NOT FINAL part333E 3M ESPE Dental Products ALCOHOL 530.7 mg/mL
48878-0620_0e44c921-d3ab-427f-8d90-6506fdd12bf9 48878-0620 HUMAN PRESCRIPTI
ON DRUG Peridex chlorhexidine gluconate RINSE ORAL 19860813
NDA NDA019028 3M ESPE Dental Products CHLORHEXIDINE GLUCONATE 1.2
mg/mL Decreased Cell Wall Integrity [PE]
48878-3100_67711d90-6eef-4ca1-9c31-169b5ff15669 48878-3100 HUMAN PRESCRIPTI
ON DRUG ControlRx sodium fluoride "PASTE, DENTIFRICE" ORAL
20050101 UNAPPROVED DRUG OTHER 3M ESPE Dental Products
SODIUM FLUORIDE 11 mg/g
48878-3101_5e9d04d7-834d-4d9f-8cba-34a924accd04 48878-3101 HUMAN PRESCRIPTI
ON DRUG ControlRx sodium fluoride "PASTE, DENTIFRICE" ORAL
48878-3110_845c37ca-808f-4119-b0f6-2a7e8b3228f8 48878-3110 HUMAN PRESCRIPTI
ON DRUG ControlRx Multi sodium fluoride "PASTE, DENTIFRICE" ORAL
48878-3120_c136259c-ec90-4347-92a7-663430bd3014 48878-3120 HUMAN PRESCRIPTI
ON DRUG Clinpro 5000 sodium fluoride "PASTE, DENTIFRICE" ORAL
48878-3130_58ed1965-4e68-4325-a4f1-1d8a9b3648b5 48878-3130 HUMAN PRESCRIPTI
48878-3140_65840b21-2ea0-449a-84aa-39976c6d5dd0 48878-3140 HUMAN PRESCRIPTI
48878-3150_c0a51486-5a0a-454c-b19b-dd11f273cedc 48878-3150 HUMAN OTC DRUG
Clinpro Tooth Creme sodium fluoride "PASTE, DENTIFRICE" ORAL
20130718 OTC MONOGRAPH FINAL part355 3M ESPE Dental Products
SODIUM FLUORIDE 2.1 mg/g
48878-3160_0a04a9d3-c869-4a4a-b96f-4f56c91553e6 48878-3160 HUMAN PRESCRIPTI
ON DRUG Fluoride Treatment sodium fluoride SOLUTION ORAL
48878-3214_97867ee1-2619-4df3-bdcc-735389152b69 48878-3214 HUMAN OTC DRUG
OrthoWash sodium fluoride RINSE ORAL 20020401
OTC MONOGRAPH FINAL part355 3M ESPE Dental Products SODIUM FLUORIDE 0.44
mg/mL
48878-3215_97867ee1-2619-4df3-bdcc-735389152b69 48878-3215 HUMAN OTC DRUG
OrthoWash sodium fluoride RINSE ORAL 20020401
OTC MONOGRAPH FINAL part355 3M ESPE Dental Products SODIUM FLUORIDE 0.44
mg/mL
48878-3223_59447e51-bb62-464c-a03d-e5094545dd92 48878-3223 HUMAN PRESCRIPTI
ON DRUG CaviRinse sodium fluoride MOUTHWASH ORAL 20050101
UNAPPROVED DRUG OTHER 3M ESPE Dental Products SODIUM FLUORIDE 2
mg/mL
48878-3315_ea28002a-4e67-40f3-a1f9-322173fadd91 48878-3315 HUMAN OTC DRUG
PerioMed stannous fluoride RINSE ORAL 19670701
OTC MONOGRAPH FINAL part355 3M ESPE Dental Products STANNOUS FLUORIDE
6.3 mg/g
6.3 mg/g
6.3 mg/g
48878-4020_88b8d315-c775-4d74-8645-624a62727235 48878-4020 HUMAN OTC DRUG
Just For Kids stannous fluoride GEL ORAL 19970701
4 mg/g
48878-4021_23b72290-e45f-4e83-9f4b-3e96967ad4cb 48878-4021 HUMAN OTC DRUG
OMNI stannous fluoride GEL ORAL 19980201
4 mg/g
4 mg/g
4 mg/g
4 mg/g
4 mg/g
4 mg/g
4 mg/g
17518-001_d3b72eb4-8b9b-4cbb-b2c4-1002840f3095 17518-001 HUMAN OTC DRUG
Hand Sanitizer Ultrathon Ethyl Alcohol GEL TOPICAL 20120409
OTC MONOGRAPH FINAL part333A 3M Health Care ALCOHOL 62 g/100mL
17518-002_c4d4dee3-d62c-4bd0-9aaf-57f0d8ff856b 17518-002 HUMAN OTC DRUG
SPF 50 Broad Spectrum Ultrathon "Avobenzone, Homosalate, Octisalate, Oct
ocrylene, Oxybenzone" LOTION TOPICAL 20120409 OTC MONOGRAPH FI
NAL part352 3M Health Care AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE;
OXYBENZONE 3; 13; 5; 7; 4 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
17518-003_2efff4ff-eb1d-4bc0-86d2-673ed3dc5f80 17518-003 HUMAN OTC DRUG
Broad Spectrum SPF 30 Ultrathon "Avobenzone, Homosalate, Octisalate, Oct
ocrylene, Oxybenzone" LIQUID TOPICAL 20120425 OTC MONOGRAPH FI
NAL part352 3M Health Care AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE;
OXYBENZONE 3; 10; 5; 2; 4 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
17518-004_a551fb6c-74b6-4e69-b1e1-133aa5dc9c0a 17518-004 HUMAN OTC DRUG
SPF 50 Broad Spectrum Ultrathon "Homosalate, Octinoxate, Octisalate, Oct
ocrylene, Zinc Oxide" STICK TOPICAL 20120409 OTC MONOGRAPH FI
NAL part352 3M Health Care HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE;
ZINC OXIDE 6; 7.5; 5; 10; 8 g/100g; g/100g; g/100g; g/100g; g/100g
17518-011_53d8dd08-2533-4c00-aa35-e86d8b195d1e 17518-011 HUMAN OTC DRUG
3M DuraPrep Surgical Iodine povacrylex and Isopropyl alcohol SOLUTION
TOPICAL 20060929 NDA NDA021586 3M Health Care IODINE P
OVACRYLEX; ISOPROPYL ALCOHOL 6.02; 636.4 mg/mL; mg/mL
17518-011_794a9f1e-d49a-4d3b-b8e9-8fa3c5a3d491 17518-011 HUMAN OTC DRUG
3M DuraPrep Surgical Iodine povacrylex and Isopropyl alcohol SOLUTION
TOPICAL 20060929 NDA NDA021586 3M Health Care IODINE P
OVACRYLEX; ISOPROPYL ALCOHOL 6.02; 636.4 mg/mL; mg/mL
17518-026_4b51fa72-bec9-4063-98f2-da86c908eeb9 17518-026 HUMAN OTC DRUG
3M Cavilon Durable Barrier Dimethicone CREAM TOPICAL 19960719
OTC MONOGRAPH FINAL part347 3M Health Care DIMETHICONE 13000 mg/L
17518-028_a6ede7b3-8dc5-4912-be69-c5d69a3759a8 17518-028 HUMAN OTC DRUG
3M Cavilon Durable Barrier Fragrance Free Dimethicone CREAM
TOPICAL 20110331 OTC MONOGRAPH FINAL part347 3M Health Care
DIMETHICONE 13000 mg/L
17518-050_56177f7e-7f7f-44e7-bd49-bd632b7564a6 17518-050 HUMAN OTC DRUG
3M Avagard D Alcohol LOTION TOPICAL 19991001 OTC MONO
GRAPH NOT FINAL part333E 3M Health Care ALCOHOL 530.7 mg/mL
17518-051_ebaaa974-013f-49c9-9ab7-8f2bacab8805 17518-051 HUMAN OTC DRUG
3M Avagard Chlorhexidine Gluconate and Alcohol LOTION TOPICAL
20010614 NDA NDA021074 3M Health Care ALCOHOL; CHLORHE
XIDINE GLUCONATE 506.3; 8.3 mg/mL; mg/mL
17518-053_209fa03b-397c-4055-8d1e-8b2fe73ef0a8 17518-053 HUMAN OTC DRUG
3M Avagard Foam Alcohol LIQUID TOPICAL 20070301 OTC MONO
GRAPH NOT FINAL part333E 3M Health Care ALCOHOL 496 mg/mL
17518-055_72d24431-c526-47ff-82da-2a558afdbb51 17518-055 HUMAN OTC DRUG
3M Avagard Foaming Instant Hand Antiseptic Alcohol LIQUID TOPICAL
20110527 OTC MONOGRAPH NOT FINAL part333E 3M Health Care
ALCOHOL 548 mg/mL
17518-056_fd965c19-206a-4d9a-806b-4c413fa691ed 17518-056 HUMAN OTC DRUG
3M Avagard Instant Hand Antiseptic with Moisturizers Alcohol GEL
TOPICAL 20130923 OTC MONOGRAPH NOT FINAL part333E 3M Healt
h Care ALCOHOL 577.7 mg/mL
17518-060_ddd2db12-e338-45c4-ad62-bb89e5f1a5ad 17518-060 HUMAN OTC DRUG
3M Skin and Nasal Antiseptic Povidone-Iodine SOLUTION TOPICAL
20090701 OTC MONOGRAPH NOT FINAL part333E 3M Health Care
POVIDONE-IODINE 5 mg/mL
17518-857_5db17e34-f83e-47d1-b04a-2668d105f3b8 17518-857 HUMAN OTC DRUG
3M Cavilon Antifungal miconazole nitrate CREAM TOPICAL 20101130
OTC MONOGRAPH FINAL part333C 3M Health Care MICONAZOLE NITRATE
2 g/1000g
64238-515_bdd20f31-e6ee-4c0c-b981-ad22b03cc9e7 64238-515 HUMAN OTC DRUG
3P Instant Hand Sanitizer ethanol GEL TOPICAL 20100321
OTC MONOGRAPH NOT FINAL part333 3-P Specialty Inc. ETHANOL 600 mL/1000m
L
50682-507_409093a5-b4f0-4857-b3d6-3d40481511d4 50682-507 HUMAN PRESCRIPTI
ON DRUG Salsalate Salsalate "TABLET, FILM COATED" ORAL
20120116 UNAPPROVED DRUG OTHER 3T Federal Solutions LLC
SALSALATE 500 mg/1
50682-508_409093a5-b4f0-4857-b3d6-3d40481511d4 50682-508 HUMAN PRESCRIPTI
ON DRUG Salsalate Salsalate "TABLET, FILM COATED" ORAL
20120116 UNAPPROVED DRUG OTHER 3T Federal Solutions LLC
SALSALATE 750 mg/1
50682-527_dec971e0-6bec-4ae4-aec4-76c8ded82c47 50682-527 HUMAN OTC DRUG
LidoPatch Pain Relief lidocaine and menthol PATCH TRANSDERMAL
20120201 OTC MONOGRAPH NOT FINAL part348 3T Federal Solutions LLC
LIDOCAINE; MENTHOL 40; 50 mg/1; mg/1
54997-186_3806df8b-4904-4daf-befc-18c4da56b71e 54997-186 HUMAN OTC DRUG
4Life Enummi Protective Day Moisturizer SPF-15 "Octinoxate, Octisalate, Avobenz
one" LOTION TOPICAL 20070801 OTC MONOGRAPH NOT FINAL part352
"4Life Research USA, LLC" AVOBENZONE; OCTINOXATE; OCTISALATE 3; 7.5;
2 g/100mL; g/100mL; g/100mL
76230-727_58d2f63d-fc89-4630-b456-7b22be39073b 76230-727 HUMAN OTC DRUG
Everyday Facial Moisturizer And Sunscreen SPF 20 ZINC OXIDE
CREAM TOPICAL 20110609 OTC MONOGRAPH FINAL part352 714 Esse
ntials LTD ZINC OXIDE 16.32 mL/100mL
10202-050_fe6fb0f0-8306-43dd-812a-c2cf5a8fe7e3 10202-050 HUMAN OTC DRUG
7 Select Ibuprofen PM "diphenhydramine citrate, ibuprofen" "TABLET,
COATED" ORAL 20140805 ANDA ANDA079113 7-Eleven
DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1
10202-056_b8a9ec6b-380b-4377-b154-7a99922430ba 10202-056 HUMAN OTC DRUG
7 select night time relief "Acetaminophen, Dextromethorphan HBr, Do
xylamine succinate" "CAPSULE, GELATIN COATED" ORAL 20140417
OTC MONOGRAPH FINAL part341 7-Eleven ACETAMINOPHEN; DEXTROMETHORPHAN
HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1
10202-130_e1f66785-1bdf-49ac-a0dd-5bc96810f92d 10202-130 HUMAN OTC DRUG
7 Select Childrens Pain Relief Acetaminophen SUSPENSION ORAL
20140813 OTC MONOGRAPH NOT FINAL part343 7-Eleven ACETAMIN
OPHEN 160 mg/5mL
10202-186_54b51ce0-5f5f-42e9-b046-714229a3ff47 10202-186 HUMAN OTC DRUG
7 Select Night Time Sleep Aid Diphenhydramine HCl LIQUID ORAL
20140422 OTC MONOGRAPH FINAL part338 7-Eleven DIPHENHY
DRAMINE HYDROCHLORIDE 50 mg/30mL
10202-194_adedd68d-5122-40c7-9998-534021e498ad 10202-194 HUMAN OTC DRUG
7 Select Acid Controller Famotidine TABLET ORAL 20140805
ANDA ANDA077351 7-Eleven FAMOTIDINE 20 mg/1
10202-224_706da376-60af-457e-bb87-d238a20ed358 10202-224 HUMAN OTC DRUG
7 Select Anti Diarrheal Loperamide HCl "TABLET, FILM COATED" ORAL
20140805 ANDA ANDA075232 7-Eleven LOPERAMIDE HYDRO
CHLORIDE 2 mg/1
10202-259_9b694189-6e16-4814-a797-ce3fb4d41dcd 10202-259 HUMAN OTC DRUG
7 Select Adult Chewable Aspirin Aspirin "TABLET, CHEWABLE" ORAL
20140805 OTC MONOGRAPH NOT FINAL part343 7-Eleven ASPIRIN
81 mg/1
10202-304_21346e24-800c-4c9f-96c4-50df8bdf71bf 10202-304 HUMAN OTC DRUG
7 Select Nasal oxymetazoline hydrochloride SPRAY NASAL 20140805
OTC MONOGRAPH FINAL part341 7-Eleven OXYMETAZOLINE HYDROCHLORIDE
0.05 g/100mL
10202-335_e0ef4b9b-6ae4-42c8-ad56-6ed64114e9f9 10202-335 HUMAN OTC DRUG
7 select night time relief "Acetaminophen, Dextromethorphan HBr, Do
xylamine succinate" SOLUTION ORAL 20140805 OTC MONO
GRAPH FINAL part341 7-Eleven ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBRO
MIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL
10202-337_8eadf0f3-cdfe-4203-a303-5be99e2f02af 10202-337 HUMAN OTC DRUG
7 Select Pink Bismuth Bismuth subsalicylate SUSPENSION ORAL
20140417 OTC MONOGRAPH FINAL part335 7-Eleven BISMUTH
SUBSALICYLATE 1050 mg/30mL
10202-368_b5f35332-2548-44a4-8d5c-9bbb1b3218ca 10202-368 HUMAN OTC DRUG
7 select naproxen sodium Naproxen Sodium "TABLET, FILM COATED"
ORAL 20140805 ANDA ANDA074661 7-Eleven NAPROXEN
SODIUM 220 mg/1
10202-374_56008815-37e9-4493-a88b-3cc30b72725e 10202-374 HUMAN OTC DRUG
7 Select Migraine Formula "Acetaminophen, Aspirin, Caffeine"
"TABLET, FILM COATED" ORAL 20140509 ANDA ANDA075794
7-Eleven ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg
/1; mg/1
10202-379_2388e766-cf6d-4b9e-ac03-65a4d1927720 10202-379 HUMAN OTC DRUG
7 select allergy childrens Diphenhydramine HCl LIQUID ORAL
DRAMINE HYDROCHLORIDE 12.5 mg/5mL
10202-416_3c60c115-37d2-44cf-bcb5-7691f8af8867 10202-416 HUMAN OTC DRUG
7 Select Aspirin Aspirin TABLET ORAL 20140805
OTC MONOGRAPH NOT FINAL part343 7-Eleven ASPIRIN 325 mg/1
10202-441_f01921ff-ed85-4f09-88bf-9abaf26e1c1c 10202-441 HUMAN OTC DRUG
7 Select Sleep Aid Doxylamine succinate TABLET ORAL 20140805
ANDA ANDA040167 7-Eleven DOXYLAMINE SUCCINATE 25 mg/1
10202-458_9831decc-17b5-4a3e-82b6-afbe3fc7edbb 10202-458 HUMAN OTC DRUG
7 select all day allergy Cetirizine Hydrochloride TABLET
ORAL 20140429 ANDA ANDA078336 7-Eleven CETIRIZI
NE HYDROCHLORIDE 10 mg/1
10202-479_21f328fa-648d-4166-9d86-2a41dd14387b 10202-479 HUMAN OTC DRUG
7 Select Allergy Diphenhydramine Hydrochloride TABLET ORAL
DRAMINE HYDROCHLORIDE 25 mg/1
10202-484_168da31e-de62-4280-9c66-2b41d2d93c31 10202-484 HUMAN OTC DRUG
7 select acetaminophen Acetaminophen TABLET ORAL 20140514
OTC MONOGRAPH NOT FINAL part343 7-Eleven ACETAMINOPHEN 500 mg/1
10202-490_c76c983e-d680-4908-b79d-968a2e4b1246 10202-490 HUMAN OTC DRUG
7 Select Naproxen Sodium Naproxen Sodium TABLET ORAL 20140811
ANDA ANDA074661 7-Eleven NAPROXEN SODIUM 220 mg/1
10202-571_f2a69f9c-6467-4fa8-a969-736a39beb142 10202-571 HUMAN OTC DRUG
7 Select Allergy Relief fexofenadine hcl "TABLET, FILM COATED"
ORAL 20140417 ANDA ANDA076447 7-Eleven FEXOFENA
DINE HYDROCHLORIDE 180 mg/1
10202-604_52caed9e-acce-4e25-af7a-fd61264fede0 10202-604 HUMAN OTC DRUG
7 select ibuprofen Ibuprofen "TABLET, FILM COATED" ORAL
20140807 ANDA ANDA072096 7-Eleven IBUPROFEN
200 mg/1
10202-612_fc61e1fb-a958-49ca-81d4-7e01c025dcdb 10202-612 HUMAN OTC DRUG
7 Select Allergy Relief Loratadine TABLET ORAL 20140514
ANDA ANDA076301 7-Eleven LORATADINE 10 mg/1
10202-647_66e2a92c-2827-413f-9349-898cc7dc009a 10202-647 HUMAN OTC DRUG
7 Select Ibuprofen Ibuprofen "TABLET, COATED" ORAL
200 mg/1
10202-656_abcd8682-a8ce-424c-9b72-65f5ada5c48a 10202-656 HUMAN OTC DRUG
7 select day time relief "acetaminophen, dextromethorphan Hbr, Ph
enylephrine HCl" SOLUTION ORAL 20140805 OTC MONO
GRAPH FINAL part341 7-Eleven ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBRO
MIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15m
L
10202-852_5418b610-7a97-46a3-80b1-95cc04408cb7 10202-852 HUMAN OTC DRUG
7 Select Acid Reducer Ranitidine "TABLET, FILM COATED" ORAL
20140422 ANDA ANDA091429 7-Eleven RANITIDINE HYDRO
CHLORIDE 150 mg/1
10202-897_0225c68b-7936-4e04-9265-c8a0e8e6a08d 10202-897 HUMAN OTC DRUG
7 Select Childrens Ibuprofen Ibuprofen SUSPENSION ORAL
100 mg/5mL
10202-906_de03ff7b-8030-4448-bcd5-b0c8d2a744e8 10202-906 HUMAN OTC DRUG
7 select cold and allergy childrens "phenylephrine hcl, brompheniram
ine maleate" LIQUID ORAL 20140805 OTC MONOGRAPH FINAL
part341 7-Eleven BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
1; 2.5 mg/5mL; mg/5mL
10202-974_079d0796-8970-4046-8fa5-ebbaccbdb98f 10202-974 HUMAN OTC DRUG
7 Select Childrens Allergy Relief cetirizine hydrochloride
SOLUTION ORAL 20140805 ANDA ANDA090254 7-Eleven
CETIRIZINE HYDROCHLORIDE 5 mg/5mL
10202-994_e61aee43-63c4-43b4-9ac8-c99a50726103 10202-994 HUMAN OTC DRUG
7 select day time relief "Acetaminophen, Dextromethorphan HBr, Ph
enylephrine HCl" "CAPSULE, LIQUID FILLED" ORAL 20140422
OTC MONOGRAPH FINAL part341 7-Eleven ACETAMINOPHEN; DEXTROMETHORPHAN
HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1
62192-8500_40f108d6-4c4d-4adb-983a-486692eb7dbd 62192-8500 HUMAN OTC DRUG
Preboost benzocaine LIQUID TOPICAL 20140218
OTC MONOGRAPH FINAL part348 944 Corp BENZOCAINE 4 g/100mL
55728-001_0ede4e05-bbf7-4fe1-b9cc-962c813d98c9 55728-001 HUMAN PRESCRIPTI
ON DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19780102
NDA NDA205737 A & B Welding Supply Co. OXYGEN 990 mL/L
55728-002_210f43c7-27dc-48b8-b12f-206bfaf18aa5 55728-002 HUMAN PRESCRIPTI
ON DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION)
20120109 NDA NDA205738 A & B Welding Supply Co.
NITROGEN 990 mL/L
64582-0001_69a81e62-78c0-4815-b1be-ba6c39305822 64582-0001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS A & D Healthcare (Equipment Repair) OXYGEN
99 L/100L
10297-001_3dcc5ef6-55ef-41e2-b5c1-311805a004c7 10297-001 HUMAN PRESCRIPTI
NDA NDA205737 A OX Welding Supply Company Inc. OXYGEN 990
mL/L
10297-002_5196cda2-d2e9-47c9-88fb-dd73c68513b7 10297-002 HUMAN PRESCRIPTI
20120109 NDA NDA205738 A OX Welding Supply Company Inc.
NITROGEN 990 mL/L
46084-012_113f7b27-dc67-473f-80ed-275c08320439 46084-012 HUMAN OTC DRUG
APTRIZINE 24-HOUR ALL DAY ALLERGY CETIRIZINE HYDROCHLORIDE TABLET
ORAL 20130221 ANDA ANDA019835 A P J Laboratories Limit
ed CETIRIZINE HYDROCHLORIDE 10 mg/1
46084-021_496c0fce-ed16-49f1-89fd-946140bcdedc 46084-021 HUMAN OTC DRUG
APROFEN REGULAR STRENGTH IBUPROFEN TABLET ORAL 20130221
OTC MONOGRAPH FINAL part343 A P J Laboratories Limited IBUPROFEN
200 mg/1
46084-031_cbc1050f-9b82-4e4c-aa84-78ba062e75b0 46084-031 HUMAN OTC DRUG
APTIDINE 75 RANITIDINE HYDROCHLORIDE TABLET ORAL 20130301
ANDA ANDA075132 A P J Laboratories Limited RANITIDINE HYDROCHLORIDE
75 mg/1
46084-041_50d6dad6-66cb-40bf-9ae0-70dd6403d46d 46084-041 HUMAN OTC DRUG
APHENAP DIPHENHYDRAMINE HYDROCHLORIDE TABLET ORAL 20130301
OTC MONOGRAPH FINAL part341 A P J Laboratories Limited DIPHENHYDRAMINE
HYDROCHLORIDE 25 mg/1
46084-051_b4133ea4-5e75-46d7-80b4-e7350c8ce234 46084-051 HUMAN OTC DRUG
GUAAP GUAIFENESIN LIQUID ORAL 20130301 OTC MONO
GRAPH FINAL part341 A P J Laboratories Limited GUAIFENESIN 100
mg/5mL
46084-061_5d9790ab-2120-4b04-a87c-d27e1e0640a2 46084-061 HUMAN OTC DRUG
APINOPHEN EXTRA STRENGTH ACETAMINOPHEN TABLET ORAL 20130301
OTC MONOGRAPH NOT FINAL part343 A P J Laboratories Limited ACETAMINOPHEN
500 mg/1
46084-071_8747131c-4c0b-4306-8bd9-b29cefb71296 46084-071 HUMAN OTC DRUG
APCAL Calcium Carbonate and Vitamin D3 TABLET ORAL 20130301
OTC MONOGRAPH FINAL part331 A P J Laboratories limited CALCIUM CARBONAT
E; CHOLECALCIFEROL 1250; 250 mg/1; [iU]/1
46084-081_8ef19bfe-6e70-4aed-979b-274315278c63 46084-081 HUMAN OTC DRUG
APTRIMAZOLE 1.0% ANTIFUNGAL CREAM CLOTRIMAZOLE CREAM TOPICAL 20130427
OTC MONOGRAPH FINAL part333C A P J Laboratories Limited CLOTRIMA
ZOLE 1 g/100g
46084-091_14d51b10-696d-4626-bb3b-143cde538b2f 46084-091 HUMAN OTC DRUG
IBUPROFEN COLD AND SINUS A P J "IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORID
E" "TABLET, COATED" ORAL 20130601 ANDA ANDA0745
67 A P J Laboratories Limited IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
200; 30 mg/1; mg/1
46084-101_529b0e8e-4f74-4d96-b9dc-c57ba66162d3 46084-101 HUMAN OTC DRUG
ACETAMINOPHEN SINUS CONGESTION AND PAIN A P J COATED "ACETAMINOPHEN, PHENYLEP
HRINE HYDROCHLORIDE" TABLET ORAL 20130606 OTC MONOGRAPH FI
NAL part341 A P J Laboratories Limited ACETAMINOPHEN; PHENYLEPHRINE HYD
ROCHLORIDE 325; 5 mg/1; mg/1
46084-111_a0c485a4-d719-42e7-8764-459756dfdae3 46084-111 HUMAN OTC DRUG
APJ HEMORRHOIDAL "PHENYLEPHRINE HYDROCHLORIDE, MINERAL OIL, PETRO
LATUM" OINTMENT TOPICAL 20130701 OTC MONOGRAPH FINAL
part346 A P J Laboratories Limited MINERAL OIL; PETROLATUM; PHENYLEPHRINE H
YDROCHLORIDE 140; 720; 2.55 mg/g; mg/g; mg/g
46084-121_c75e18ea-fbbe-477e-a961-6ce6d1954cab 46084-121 HUMAN OTC DRUG
DAYTIME NIGHTTIME COLD/FLU RELIEF A P J DAYTIME NIGHTTIME COLD/FLU RELIE
F KIT 20130601 OTC MONOGRAPH FINAL part341
A P J Laboratories Limited
51130-333_98f9f508-2419-4c45-aee4-4c0974423010 51130-333 HUMAN OTC DRUG
CaraDerma benzoyl peroxide CREAM TOPICAL 20100902
OTC MONOGRAPH NOT FINAL part333D "A Refreshing Discovery, Inc." BENZOYL
PEROXIDE 1.125 g/15g
50943-001_3b65d02e-38b1-4f67-8a30-fb7aa42d1ee2 50943-001 HUMAN OTC DRUG
Top Medicated "CAMPHOR (NATURAL), MENTHOL,METHYL SALICYLATE" OIL
TOPICAL 20120524 OTC MONOGRAPH FINAL part348 A&A Medical Supp
lies CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 10; 16; 50 mL/100mL
; mL/100mL; mL/100mL
62211-166_8c5b275b-a792-4f2a-a658-95a70b428021 62211-166 HUMAN OTC DRUG
D-CAL calcium carbonate "TABLET, CHEWABLE" ORAL 19970917
OTC MONOGRAPH FINAL part331 A&Z Pharmaceutical Inc. CALCIUM CARBONATE
750 mg/1
62211-838_91cfadbe-8fca-499f-a029-ec486c1d2412 62211-838 HUMAN OTC DRUG
Aspirin Aspirin TABLET ORAL 20130919 OTC MONOGRAPH FI
NAL part343 A&Z Pharmaceutical Inc. ASPIRIN 81 mg/1
62211-309_f6eba2c6-7a53-4520-bbae-e5d0b4234f93 62211-309 HUMAN OTC DRUG
Allergy Relief Loratadine 10 mg TABLET ORAL 20131205
ANDA ANDA019658 "A&Z Pharmaceutical, Inc" LORATADINE 10
mg/1
62211-010_2e2e7b0c-f124-430d-a592-e1d13b203117 62211-010 HUMAN OTC DRUG
Acetaminophen Acetaminophen TABLET ORAL 20090814
OTC MONOGRAPH NOT FINAL part343 "A&Z Pharmaceutical, Inc." ACETAMINOPHEN
325 mg/1
62211-011_f188c3d6-c7aa-4e08-89e5-9c3f9b61227f 62211-011 HUMAN OTC DRUG
500 mg/1
62211-012_e7fa7bfc-55e4-495d-95d2-fac45c9aa841 62211-012 HUMAN OTC DRUG
Pain Relief ES Acetaminophen TABLET ORAL 20140610
500 mg/1
62211-023_276769c2-2ab6-4380-a54c-3699e1d41ac2 62211-023 HUMAN OTC DRUG
Children Acetaminophen Children Acetaminophen "TABLET, CHEWABLE"
ORAL 20030310 OTC MONOGRAPH NOT FINAL part343 "A&Z Pharmaceuti
cal, Inc." ACETAMINOPHEN 80 mg/1
62211-046_17ae651c-b552-4fef-a3cc-d62598d051a8 62211-046 HUMAN OTC DRUG
Bismuth Subsalicylate Bismuth Subsalicylate "TABLET, CHEWABLE"
ORAL 20030310 OTC MONOGRAPH FINAL part335 "A&Z Pharmaceuti
cal, Inc." BISMUTH SUBSALICYLATE 262 mg/1
62211-048_9ee96942-020f-4a1d-9123-622d62652136 62211-048 HUMAN OTC DRUG
Diphenhydramine HCl Diphenhydramine HCl "TABLET, COATED"
cal, Inc." DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1
62211-070_4420c82c-32ca-436f-b678-f1189c9eb983 62211-070 HUMAN OTC DRUG
Simethicone Cherry Flavored Chewable Simethicone Cherry Flavored Chew
able "TABLET, CHEWABLE" ORAL 20030310 OTC MONOGRAPH FI
NAL part332 "A&Z Pharmaceutical, Inc." DIMETHICONE 80 mg/1
62211-127_d3bc1582-be9b-4a30-ba01-587132319b44 62211-127 HUMAN OTC DRUG
D-Cal SoyCal calcium carbonate and soy isoflavones and vitamin D3
TABLET ORAL 20100122 OTC MONOGRAPH FINAL part331 "A&Z Pha
rmaceutical, Inc." CALCIUM CARBONATE; CHOLECALCIFEROL; SOY ISOFLAVONES
28.32; 480; 1 g/1; ug/1; g/1
62211-165_6b216230-7532-4922-b206-9663e33e5f67 62211-165 HUMAN OTC DRUG
Children Acetaminophen Grape Flavored Chewable Acetaminophen "TABLET,
CHEWABLE" ORAL 20030310 OTC MONOGRAPH NOT FINAL part343
"A&Z Pharmaceutical, Inc." ACETAMINOPHEN 80 mg/1
62211-174_debb6590-0a33-4ba1-be0e-2d744738af8d 62211-174 HUMAN OTC DRUG
Magnesium Oxide Magnesium Oxide TABLET ORAL 20031203
OTC MONOGRAPH FINAL part331 "A&Z Pharmaceutical, Inc." MAGNESIUM OXIDE
400 mg/1
62211-196_6cf8c8fc-3b73-4598-9114-6db25fd2d55a 62211-196 HUMAN OTC DRUG
D-Cal Kids Calcium Carbonate "TABLET, CHEWABLE" ORAL
19970917 OTC MONOGRAPH FINAL part331 "A&Z Pharmaceutical, Inc
." CALCIUM CARBONATE 750 mg/1
62211-219_33376895-edf5-4dde-8614-b9798e97b9ed 62211-219 HUMAN OTC DRUG
Calcium Antacid Calcium Carbonate "TABLET, CHEWABLE" ORAL
." CALCIUM CARBONATE 500 mg/1
62211-220_45871422-26c9-4cf4-8bb4-e2963e6d4146 62211-220 HUMAN OTC DRUG
Aspirin Aspirin "TABLET, COATED" ORAL 20091103
OTC MONOGRAPH FINAL part343 "A&Z Pharmaceutical, Inc." ASPIRIN 81
mg/1
62211-225_05b57e0c-508e-4767-9e40-4749b0c764a2 62211-225 HUMAN OTC DRUG
OTC MONOGRAPH FINAL part343 "A&Z Pharmaceutical, Inc." ASPIRIN 325
mg/1
62211-239_8c45d37d-01f6-4d0a-83b0-eaa1cfec605f 62211-239 HUMAN OTC DRUG
D-Cal Kids Calcium Carbonate GRANULE ORAL 20080104
OTC MONOGRAPH FINAL part331 "A&Z Pharmaceutical, Inc." CALCIUM CARBONAT
E 750 mg/g
62211-246_1e1c45b1-06e7-4e69-9932-17663d79fef7 62211-246 HUMAN OTC DRUG
Chlorpheniramine maleate Chlorpheniramine maleate TABLET
cal, Inc." CHLORPHENIRAMINE MALEATE 4 mg/1
62211-267_89f5a830-2d57-4238-b88f-2bb73af8240e 62211-267 HUMAN OTC DRUG
Bioelectro Night Acetaminophen and Diphenhydramine HCI TABLET
cal, Inc." ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg
/1
62211-267_bc17640c-78e0-47d0-8b5c-7d6338b6d181 62211-267 HUMAN OTC DRUG
Pain Relief PM acetaminophen and diphenhydramine hydrochloride "TABLET,
COATED" ORAL 20040220 OTC MONOGRAPH NOT FINAL part343
"A&Z Pharmaceutical, Inc." ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
500; 25 mg/1; mg/1
62211-272_6046a85f-19e6-4d7f-b0bf-89897276f8ab 62211-272 HUMAN OTC DRUG
Phenylephrine HCl Phenylephrine HCl TABLET ORAL 20091103
OTC MONOGRAPH FINAL part341 "A&Z Pharmaceutical, Inc." PHENYLEPHRINE HY
DROCHLORIDE 10 mg/1
62211-285_1f947edc-a977-4353-a9ed-956a3d55f59c 62211-285 HUMAN OTC DRUG
BioElectro Day Acetaminophen and Aspirin and Caffeine TABLET ORAL
20050518 OTC MONOGRAPH NOT FINAL part343 "A&Z Pharmaceutical, Inc
." ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1
62211-312_4b10cb66-7990-4e67-b726-3f6409c7e601 62211-312 HUMAN OTC DRUG
NAL part343 "A&Z Pharmaceutical, Inc." ASPIRIN 325 mg/1
62211-314_5cbac076-0fa4-4eae-83b7-6c71b7f5d1fd 62211-314 HUMAN OTC DRUG
Docusate Sodium Docusate Sodium "CAPSULE, LIQUID FILLED" ORAL
." DOCUSATE SODIUM 100 mg/1
62211-335_d40d1813-9f2f-4e0c-b7eb-2532cebc5d8e 62211-335 HUMAN OTC DRUG
Ibuprofen (NSAID) Pain Reliever/Fever Reducer Ibuprofen TABLET
cal, Inc." IBUPROFEN 200 mg/1
62211-338_d40d1813-9f2f-4e0c-b7eb-2532cebc5d8e 62211-338 HUMAN OTC DRUG
Ibuprofen (NSAID) Pain Reliever/Fever Reducer Ibuprofen CAPSULE
cal, Inc." IBUPROFEN 200 mg/1
62211-339_487ebb57-c1e7-4ac8-834b-868d961b89a2 62211-339 HUMAN OTC DRUG
Daytime Cold and Flu Relief "Acetaminophen, Dextromethorphan HBr, Ph
enylephrine HCI" "CAPSULE, LIQUID FILLED" ORAL 20110609
OTC MONOGRAPH FINAL part341 "A&Z Pharmaceutical, Inc." ACETAMINOPHEN; D
EXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5
mg/1; mg/1; mg/1
62211-340_6251afbd-7314-446c-843c-f35e035e9f49 62211-340 HUMAN OTC DRUG
Nighttime Cold and Flu Relief "Acetaminophen, Dextromethorphan HBr, Do
xylamine succinate" "CAPSULE, LIQUID FILLED" ORAL 20110325
OTC MONOGRAPH NOT FINAL part343 "A&Z Pharmaceutical, Inc." ACETAMINOPHEN; D
EXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg
/1; mg/1
62211-350_4a144ecb-df2e-430d-844b-9fd02e3108d3 62211-350 HUMAN OTC DRUG
Allergy Relief Cetirizine HCl 10 mg TABLET ORAL 20131210
ANDA ANDA078317 "A&Z Pharmaceutical, Inc." CETIRIZINE HYDROCHLORIDE
10 mg/1
62211-839_ce60796c-4a74-482b-b345-2053f682c81c 62211-839 HUMAN OTC DRUG
NAL part343 "A&Z Pharmaceutical, Inc." ASPIRIN 325 mg/1
18754-061_f7fd4460-ffa4-402d-878d-016208e07d2d 18754-061 HUMAN PRESCRIPTI
ON DRUG Methscopolamine Bromide methscopolamine bromide TABLET ORAL
20091022 NDA NDA008848 A. Aarons METHSCOPOLAMINE
BROMIDE 2.5 mg/1
18754-062_f7fd4460-ffa4-402d-878d-016208e07d2d 18754-062 HUMAN PRESCRIPTI
ON DRUG Methscopolamine Bromide methscopolamine bromide TABLET ORAL
20091022 NDA NDA008848 A. Aarons METHSCOPOLAMINE
BROMIDE 5 mg/1
62149-0002_39f9447a-f7c9-4c90-a3de-55577eff4b3c 62149-0002 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS A.M. Home Diagnostics Inc. dba Healthline
OXYGEN 99 L/100L
63398-1072_670ca6ff-5237-4e6f-b33a-31957a29bf25 63398-1072 HUMAN PRESCRIPTI
ON DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19820101
UNAPPROVED MEDICAL GAS A.V. Pulmonary Care OXYGEN 99 L/100L
54194-268_166348ec-f7f7-419b-bdee-0a62e73d948d 54194-268 HUMAN OTC DRUG
ariSulfur Acne Treatment Sulfur SOAP TOPICAL 20130528
OTC MONOGRAPH FINAL part333D A+Plus Medical Center Limited SULFUR
10 g/100g
57344-001_00347e67-180f-4c09-9fd7-98267ef3ec1d 57344-001 HUMAN OTC DRUG
OTC MONOGRAPH NOT FINAL part343 "AAA Pharmaceutical, Inc." ACETAMINOPHEN
325 mg/1
57344-003_ea5b34f0-4ad2-404f-a2ec-88c7bc17fbf8 57344-003 HUMAN OTC DRUG
500 mg/1
57344-004_f5c97070-c7eb-43d7-888e-9864af4fcfb5 57344-004 HUMAN OTC DRUG
Acetaminophen Acetaminophen "TABLET, COATED" ORAL 20121213
500 mg/1
57344-018_aefa6f29-c36c-4db6-bfb7-a2df5ab3a47a 57344-018 HUMAN OTC DRUG
Aspirin ASPIRIN "TABLET, COATED" ORAL 20121215
OTC MONOGRAPH NOT FINAL part343 "AAA Pharmaceutical, Inc." ASPIRIN 325
mg/1
57344-019_b70eecaa-44d5-4b55-9247-c6f33b6b5e74 57344-019 HUMAN OTC DRUG
Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE TABLET
ORAL 20121215 OTC MONOGRAPH FINAL part338 "AAA Pharmaceuti
57344-020_ebb60cf2-3eee-49ec-b08a-220e43f1f486 57344-020 HUMAN OTC DRUG
Caffeine CAFFEINE TABLET ORAL 20121215
OTC MONOGRAPH FINAL part340 "AAA Pharmaceutical, Inc." CAFFEINE
200 mg/1
57344-028_fb728dad-2054-4f60-85a9-4b49ecf081ef 57344-028 HUMAN OTC DRUG
Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE TABLET
57344-035_0f500946-18c8-4139-8f09-3bf58fd85c95 57344-035 HUMAN OTC DRUG
Pseudoephedrine Hydrochloride PSEUDOEPHEDRINE HYDROCHLORIDE "TABLET,
COATED" ORAL 20121222 OTC MONOGRAPH FINAL part341
"AAA Pharmaceutical, Inc." PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1
57344-080_10c8873c-bcbd-4fe5-8358-775eb9abdb8b 57344-080 HUMAN OTC DRUG
Aspirin ASPIRIN "TABLET, DELAYED RELEASE" ORAL 20121215
mg/1
57344-081_a6f227fc-1807-4d88-a7b0-a0fa4e9d9f5d 57344-081 HUMAN OTC DRUG
mg/1
57344-090_d9529bb8-12e2-4115-8d08-35076244fa64 57344-090 HUMAN OTC DRUG
Diphenhydramine DIPHENHYDRAMINE HYDROCHLORIDE "TABLET, COATED"
57344-091_68084330-aaed-4ea9-a002-0a34b7312e5e 57344-091 HUMAN OTC DRUG
Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE "TABLET,
"AAA Pharmaceutical, Inc." DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1
57344-092_c139cf5d-3428-4271-ada1-f20b434dcbcb 57344-092 HUMAN OTC DRUG
500 mg/1
57344-095_052c52a3-1bc5-499c-8cc8-b28c1547bd7d 57344-095 HUMAN OTC DRUG
Acetaminophen PM Acetaminophen and DIPHENHYDRAMINE HYDROCHLORIDE
"TABLET, COATED" ORAL 20121213 OTC MONOGRAPH FINAL
part338 "AAA Pharmaceutical, Inc." ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLO
RIDE 500; 25 mg/1; mg/1
57344-098_158799bd-d45c-4779-b2d2-2b68ffaba23d 57344-098 HUMAN OTC DRUG
500 mg/1
57344-101_8318049c-8927-4544-b050-499fb34d8956 57344-101 HUMAN OTC DRUG
"Acetaminophen, Diphenhydramine Hydrochloride" ACETAMINOPHEN and DIPHEN
HYDRAMINE HYDROCHLORIDE "TABLET, COATED" ORAL 20121222
OTC MONOGRAPH FINAL part341 "AAA Pharmaceutical, Inc." ACETAMINOPHEN; D
IPHENHYDRAMINE HYDROCHLORIDE 500; 12.5 mg/1; mg/1
57344-105_fc3ea080-77cb-4da8-a916-afc70bfc738f 57344-105 HUMAN OTC DRUG
Aspirin ASPIRIN "TABLET, CHEWABLE" ORAL 20121215
mg/1
57344-109_60e8efbe-7e39-4698-9bdf-50b6487bf523 57344-109 HUMAN OTC DRUG
Ibuprofen Ibuprofen "TABLET, COATED" ORAL 20121204
ANDA ANDA079129 "AAA Pharmaceutical, Inc." IBUPROFEN 200
mg/1
57344-110_55f21d7c-3c42-4044-965a-aaadefcc4ba1 57344-110 HUMAN OTC DRUG
mg/1
57344-111_a13e3b28-9a54-462e-bbe4-c7a6452c5b5b 57344-111 HUMAN OTC DRUG
mg/1
57344-112_19d120e6-ff7a-4e2e-bd25-e8c89c99beb7 57344-112 HUMAN OTC DRUG
mg/1
57344-113_82d0cc68-3a24-4f86-bdb8-00f3cf364375 57344-113 HUMAN OTC DRUG
Diphenhydramine DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE ORAL 20121222
OTC MONOGRAPH FINAL part341 "AAA Pharmaceutical, Inc." DIPHENHYDRAMINE
57344-119_8cefa83b-202c-41d0-9965-ed615ffce5eb 57344-119 HUMAN OTC DRUG
"Acetaminophen, Guaifenesin, Phenylephrine Hydrochloride" "ACETAMI
NOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE" "TABLET, COATED"
cal, Inc." ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200
; 5 mg/1; mg/1; mg/1
57344-120_e3f2dfa7-3762-40ba-9ecd-7e6aeb3c1562 57344-120 HUMAN OTC DRUG
"Acetaminophen, Phenylephrine Hydrochloride" ACETAMINOPHEN and PHENYL
EPHRINE HYDROCHLORIDE "TABLET, COATED" ORAL 20121222
OTC MONOGRAPH FINAL part341 "AAA Pharmaceutical, Inc." ACETAMINOPHEN; P
HENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1
57344-123_d7402b15-fa6c-4197-98e2-b4ecad1b64c4 57344-123 HUMAN OTC DRUG
57344-124_61c8f3f8-37b8-46c2-a90a-d97f2b057ca6 57344-124 HUMAN OTC DRUG
"Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride"
"Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride"
RIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/1; mg/1; mg/1
57344-125_69471d5f-7f6e-4fd9-ae53-f4ce2866d101 57344-125 HUMAN OTC DRUG
57344-126_2ca2f908-51b2-47d9-a0b7-4da58ac6ab33 57344-126 HUMAN OTC DRUG
"Acetaminophen, Diphenhydramine Hyhrochloride, Phenylephrine Hydrochloride"
"ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, and PHENYLEPHRINE HYDROCHLORIDE"
RIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 25; 5 mg/1; mg/1; mg/1
57344-127_638ae864-5a49-46b4-9a41-aa926e2a0305 57344-127 HUMAN OTC DRUG
57344-128_d28e5412-c97c-4ed8-bb1c-47f44e8f0547 57344-128 HUMAN OTC DRUG
"Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hydrochloride"
"ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, and PHENYLEPHRINE HYDROCHLORIDE"
part341 "AAA Pharmaceutical, Inc." ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE;
PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1
57344-131_6e19e526-1f1c-41ba-90ff-bbaff1e3ecf8 57344-131 HUMAN OTC DRUG
Phenylephrine Hydrochloride PHENYLEPHRINE HYDROCHLORIDE "TABLET,
"AAA Pharmaceutical, Inc." PHENYLEPHRINE HYDROCHLORIDE 10 mg/1
57344-133_3b1386d4-3060-44dd-94f2-7e95a7d126ed 57344-133 HUMAN OTC DRUG
"Chlorpheniramine Maleate, Phenylephrine Hydrochloride" CHLORPHENIRAMINE
MALEATE and PHENYLEPHRINE HYDROCHLORIDE "TABLET, COATED" ORAL
20121222 OTC MONOGRAPH FINAL part341 "AAA Pharmaceutical, Inc
." CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg
/1
57344-134_ad636072-c579-423d-a291-6574e43f1187 57344-134 HUMAN OTC DRUG
"Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydroc
hloride" "ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENES
IN, and PHENYLEPHRINE HYDROCHLORIDE" "TABLET, COATED" ORAL 20121222
EXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10;
100; 5 mg/1; mg/1; mg/1; mg/1
57344-136_8ffe8753-299d-46e2-a967-d7d1512bba2a 57344-136 HUMAN OTC DRUG
200; 5 mg/1; mg/1; mg/1; mg/1
57344-138_e63493e7-61f1-4e10-86c3-25e26e18b807 57344-138 HUMAN OTC DRUG
"Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride"
"ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE"
part341 "AAA Pharmaceutical, Inc." ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBRO
MIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1
57344-139_91cd3662-4fd2-479f-ad1d-618b81f6f839 57344-139 HUMAN OTC DRUG
"Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenyle
phrine Hydrochloride" "ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTRO
METHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE" "TABLET, COATED"
cal, Inc." ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROB
ROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1
57344-144_e4a322f3-1cce-4c34-ac8a-21b218a879ff 57344-144 HUMAN OTC DRUG
Naproxen Sodium NAPROXEN SODIUM "TABLET, COATED" ORAL 20121215
ANDA ANDA079096 "AAA Pharmaceutical, Inc." NAPROXEN SODIUM 220
mg/1
57344-145_5d765fcc-bfa7-4791-b533-b28f73b01f40 57344-145 HUMAN OTC DRUG
Naproxen Sodium NAPROXEN SODIUM "TABLET, COATED" ORAL 20121215
ANDA ANDA079096 "AAA Pharmaceutical, Inc." NAPROXEN SODIUM 220
mg/1
57344-146_c18169d7-dbd3-4c01-8296-e060259c32e6 57344-146 HUMAN OTC DRUG
mg/1
57344-147_d10f835d-c53b-4083-960a-fdaddb965db0 57344-147 HUMAN OTC DRUG
Day and Night Cold "Acetaminophen, Dextromethorphan Hydrobromide, D
iphenhydramine Hydrochloride, Guaifenesin, and Phenylephrine Hydrochloride"
KIT 20121228 OTC MONOGRAPH FINAL part341 "AAA Pha
rmaceutical, Inc."
57344-149_f0b42e7b-eab2-4048-b894-706ba48f4330 57344-149 HUMAN OTC DRUG
Sinus Congestion and Pain Daytime Nighttime "Acetaminophen, Chlorphe
niramine Maleate, and Phenylephrine Hydrochloride" KIT 20121228
OTC MONOGRAPH FINAL part341 "AAA Pharmaceutical, Inc."
57344-150_fff544f0-d591-4846-b1a4-e8bb980802a6 57344-150 HUMAN OTC DRUG
Cold Multi-Symptom Daytime Nighttime "Acetaminophen, Chlorpheniramine
Maleate, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride"
KIT 20121228 OTC MONOGRAPH FINAL part341 "AAA Pha
rmaceutical, Inc."
57344-152_ba405a82-f20f-4160-9b79-b4bf16d13f91 57344-152 HUMAN OTC DRUG
Aspirin ASPIRIN "TABLET, CHEWABLE" ORAL 20121215
mg/1
57344-154_8574bbc6-eb08-45d1-b37c-66bc8bd2dd9e 57344-154 HUMAN OTC DRUG
57344-155_37b30e79-02e8-41ec-a0b2-c1d4a9173e1b 57344-155 HUMAN OTC DRUG
57344-156_faca8b2e-d481-4bbd-b464-85cc773bc298 57344-156 HUMAN OTC DRUG
57344-157_1f1f3f18-e27e-4d3e-95e1-0aca99bda81d 57344-157 HUMAN OTC DRUG
"Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hydrochloride"
"ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, and PHENYLEPHRINE HYDROCHLORIDE"
part341 "AAA Pharmaceutical, Inc." ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE;
PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1
57344-158_462fdf0c-9490-4fdf-9c9c-c31ecf0d4a5e 57344-158 HUMAN OTC DRUG
"Chlorpheniramine Maleate, Phenylephrine Hydrochloride" CHLORPHENIRAMINE
MALEATE and PHENYLEPHRINE HYDROCHLORIDE "TABLET, COATED" ORAL
20121222 OTC MONOGRAPH FINAL part341 "AAA Pharmaceutical, Inc
." CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg
/1
57344-159_315efefa-c8e5-47c5-9594-cc749c155a8f 57344-159 HUMAN OTC DRUG
hloride" "Acetaminophen, Dextromethorphan Hydrobromide, Guaifenes
in, and Phenylephrine Hydrochloride" "TABLET, COATED" ORAL 20121228
200; 5 mg/1; mg/1; mg/1; mg/1
57344-160_1b6854b7-927b-452b-8eab-66d660db5ba3 57344-160 HUMAN OTC DRUG
"Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride"
"ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE"
part341 "AAA Pharmaceutical, Inc." ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBRO
MIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1
57344-161_235bb3fd-b4e3-44c6-82b5-230ca26e610b 57344-161 HUMAN OTC DRUG
"Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenyle
phrine Hydrochloride" "ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTRO
METHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE" "TABLET, COATED"
cal, Inc." ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROB
57344-162_b79b6936-d18b-4604-a155-6a16eb23dd61 57344-162 HUMAN OTC DRUG
Cold Head Congestion Daytime / Nighttime "Acetaminophen, Chlorphe
niramine Maleate, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride
" KIT 20121228 OTC MONOGRAPH FINAL part341
"AAA Pharmaceutical, Inc."
57344-163_2e4cad0f-e170-45ef-bb17-684eb1e2cbcd 57344-163 HUMAN OTC DRUG
200; 5 mg/1; mg/1; mg/1; mg/1
57344-170_f1ba6a9d-ddb6-441e-b44e-9c55a029cddd 57344-170 HUMAN OTC DRUG
Acetaminophen Rapid Release Acetaminophen "TABLET, COATED"
ORAL 20140326 OTC MONOGRAPH NOT FINAL part343 "AAA Pharmaceuti
cal, Inc." ACETAMINOPHEN 500 mg/1
57344-171_46830d77-d9fb-4082-946b-9f0392eadae5 57344-171 HUMAN OTC DRUG
Acetaminophen PM Rapid Release Acetaminophen and DIPHENHYDRAMINE HYDROC
HLORIDE "TABLET, COATED" ORAL 20140326 OTC MONOGRAPH FI
NAL part341 "AAA Pharmaceutical, Inc." ACETAMINOPHEN; DIPHENHYDRAMINE H
YDROCHLORIDE 500; 25 mg/1; mg/1
49580-0126_330a17a1-029d-4dd7-8203-c5bd9b79ce29 49580-0126 HUMAN OTC DRUG
Tussin CF "Dextromethorphan HBr, Guaifenesin, Phenylephrine HCL" Robituss
in CF LIQUID ORAL 20050110 OTC MONOGRAPH FINAL part341
Aaron Industries Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRIN
E HYDROCHLORIDE 10; 100; 5 mg/5mL; mg/5mL; mg/5mL
49580-2411_4e1ac9c7-e088-44d6-88c0-a6ac9aab7082 49580-2411 HUMAN OTC DRUG
Tussin CF Robitussin CF LIQUID ORAL 20091001
OTC MONOGRAPH FINAL part341 Aaron Industries Inc DEXTROMETHORPHAN HYDROBR
OMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/5mL; mg/5mL;
mg/5mL
49580-3412_c18efabd-24c7-4eba-9873-aff88ea02bf4 49580-3412 HUMAN OTC DRUG
Tussin Cough Long Acting Robitussin Cough Long Acting LIQUID
ORAL 20100113 OTC MONOGRAPH FINAL part341 Aaron Industries
Inc DEXTROMETHORPHAN HYDROBROMIDE 10 mg/5mL
49580-0014_62faefde-a0a2-4236-866d-e5fa6fb4de55 49580-0014 HUMAN OTC DRUG
Hydrogen Peroxide Hydrogen Peroxide LIQUID TOPICAL 20131204
OTC MONOGRAPH NOT FINAL part356 Aaron Industries Inc (SC) HYDROGEN PEROXID
E 2.65 mL/100mL
49580-0108_75a9f2e9-dba4-4a55-a151-912f735e8912 49580-0108 HUMAN OTC DRUG
Milk of Magnesia Original Phillips Milk of magnesia Original
SUSPENSION ORAL 20090813 OTC MONOGRAPH FINAL part334
Aaron Industries Inc. MAGNESIUM HYDROXIDE 1200 mg/15mL
49580-0271_51687255-726d-4bd2-9b4f-2692f1d9ec50 49580-0271 HUMAN OTC DRUG
Isopropyl alcohol 50 percent ReadyInCase Isopropyl alcohol LIQUID
TOPICAL 20140630 OTC MONOGRAPH NOT FINAL part333A Aaron In
dustries Inc. ISOPROPYL ALCOHOL 50 mL/100mL
49580-0272_82eeeb51-3c96-4a6a-8197-678ebedd6ad8 49580-0272 HUMAN OTC DRUG
Isopropyl alcohol 50 percent Wintergreen ReadyInCase Isopropyl alcoho
l LIQUID TOPICAL 20140630 OTC MONOGRAPH NOT FINAL part333A
Aaron Industries Inc. ISOPROPYL ALCOHOL 50 mL/100mL
49580-0275_d2c3fdc5-2c06-4bc0-8896-51a140b1bec8 49580-0275 HUMAN OTC DRUG
Isopropyl alcohol 70 percent ReadyInCase Isopropyl alcohol LIQUID
TOPICAL 20140630 OTC MONOGRAPH NOT FINAL part333A Aaron In
dustries Inc. ISOPROPYL ALCOHOL 70 mL/100mL
49580-0329_db8f62f5-7318-44ca-ada3-3c7cf5b1b268 49580-0329 HUMAN OTC DRUG
Magnesium Citrate Lemon ReadyInCase Magnesium citrate LIQUID
ORAL 20140630 OTC MONOGRAPH NOT FINAL part334 Aaron Industries
Inc. MAGNESIUM CITRATE 1.745 g/29.6mL
49580-0344_1077c176-7378-4fab-9319-081b4f854059 49580-0344 HUMAN OTC DRUG
Nighttime Cold and Flu ReadyInCase "Acetaminophen, Dextromethorphan Hydrobr
omide, Doxylamine Succinate" LIQUID ORAL 20140630 OTC MONO
GRAPH FINAL part341 Aaron Industries Inc. ACETAMINOPHEN; DEXTROMETHORPHAN
HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15m
L
49580-0345_58512b4d-423b-4ef4-9256-1a3dce6c0d2b 49580-0345 HUMAN OTC DRUG
Nighttime Cough all night cough relief "Dextromethorphan Hydrobromide, Doxylami
ne Succinate" LIQUID ORAL 20140731 OTC MONOGRAPH FINAL
part341 Aaron Industries Inc. DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCIN
ATE 30; 12.5 mg/30mL; mg/30mL
49580-0902_be1156ca-4bd0-438f-bee8-eab7b3584259 49580-0902 HUMAN OTC DRUG
91 Percent Isopropyl alcohol Isopropyl alcohol LIQUID TOPICAL
20120820 OTC MONOGRAPH NOT FINAL part333A Aaron Industries
Inc. ISOPROPYL ALCOHOL 91 mL/100mL
49580-1108_301d383c-0455-4d7a-ae91-8d315b942673 49580-1108 HUMAN OTC DRUG
Milk of Magnesia Mint MAGNESIUM HYDROXIDE SUSPENSION ORAL
20090708 OTC MONOGRAPH FINAL part334 Aaron Industries Inc.
MAGNESIUM HYDROXIDE 1200 mg/15mL
49580-0024_81ac8883-d38a-4376-b6e3-ed64b7f2b3d5 49580-0024 HUMAN OTC DRUG
Peptic Relief Maximum Strength Maximum Strength Pepto Bismol SUSPENSI
ON ORAL 20131211 OTC MONOGRAPH FINAL part335 "Aaron I
ndustries, Inc." BISMUTH SUBSALICYLATE 525 mg/15mL
49580-0106_c1677ac4-15d2-40ba-9940-441fda5c0364 49580-0106 HUMAN OTC DRUG
Antacid Antigas Mylanta SUSPENSION ORAL 20090408
OTC MONOGRAPH FINAL part331 "Aaron Industries, Inc." ALUMINUM HYDROXI
DE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL
49580-0110_cf245ddb-fd9c-4da1-a2b2-b7abc20cc5d8 49580-0110 HUMAN OTC DRUG
Peptic Relief Pepto Bismol SUSPENSION ORAL 20100108
OTC MONOGRAPH FINAL part335 "Aaron Industries, Inc." BISMUTH SUBSALIC
YLATE 262 mg/15mL
49580-0115_103c67d7-102b-4c46-9f8c-929bacdaa301 49580-0115 HUMAN OTC DRUG
Antacid Supreme Cherry Mylanta Supreme Cherry SUSPENSION ORAL
20090324 OTC MONOGRAPH FINAL part331 "Aaron Industries, Inc."
ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE 400; 135 mg/5mL; mg/5mL
49580-0122_5df719a4-3e77-494a-bd88-de6899133849 49580-0122 HUMAN OTC DRUG
Antacid Antigas Maximum Strength Original Antacid Antigas Maximum
Strength Mylanta Original SUSPENSION ORAL 20090409
OTC MONOGRAPH FINAL part331 "Aaron Industries, Inc." ALUMINUM HYDROXI
DE; DIMETHICONE; MAGNESIUM HYDROXIDE 400; 40; 400 mg/5mL; mg/5mL; mg/5mL
49580-0142_08d15545-f555-44d1-beb8-836ba1e13160 49580-0142 HUMAN OTC DRUG
Day Time with PE "Acetaminophen, Dextromethorphan Hydrobromide, P
henylephrine Hydrochloride" LIQUID ORAL 20070102 OTC MONO
GRAPH FINAL part341 "Aaron Industries, Inc." ACETAMINOPHEN; DEXTROMET
HORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL;
mg/15mL; mg/15mL
49580-0155_aca10c35-feff-4015-9324-68f32e027fc7 49580-0155 HUMAN OTC DRUG
Flu Relief Therapy Day Time Theraflu Daytime LIQUID ORAL
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
325; 10; 5 mg/15mL; mg/15mL; mg/15mL
49580-0158_dba29ae6-8151-477d-816c-c713bfa55293 49580-0158 HUMAN OTC DRUG
Childrens Mucus Relief Cough Cherry Childrens Mucinex Cough LIQUID
ORAL 20131212 OTC MONOGRAPH FINAL part341 "Aaron Industrie
s, Inc." DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL;
mg/5mL
49580-0192_38da9ace-441f-4ad8-bd00-3affa282acfd 49580-0192 HUMAN OTC DRUG
Day Time Cold Multi-Symptom Cool Blast Tylenol Multi Symptom Cool Blast
Daytime LIQUID ORAL 20100101 OTC MONOGRAPH FINAL
part341 "Aaron Industries, Inc." ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBRO
MIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/5mL; mg/5mL;
mg/5mL; mg/5mL
49580-0210_d5be65c6-01fa-4c02-b875-f7fbf0cd65e8 49580-0210 HUMAN OTC DRUG
49580-0242_38a35cd7-4772-47cc-9c9c-27c5d6c35e74 49580-0242 HUMAN OTC DRUG
EZ Nite Sleep ZzzQuil LIQUID ORAL 20130101 OTC MONO
GRAPH FINAL part341 "Aaron Industries, Inc." DIPHENHYDRAMINE HYDROCHL
ORIDE 50 mg/30mL
49580-0300_c5fe260c-a9f2-44d7-bc95-45217e4eca8d 49580-0300 HUMAN OTC DRUG
Hydrogen Peroxide Hydrogen Peroxide LIQUID ORAL; TOPICAL
20090730 OTC MONOGRAPH NOT FINAL part356 "Aaron Industries, Inc."
HYDROGEN PEROXIDE 2.65 mL/100mL
49580-0300_c6e23804-15cb-4213-bcd1-341b99297b25 49580-0300 HUMAN OTC DRUG
OTC MONOGRAPH NOT FINAL part356 "Aaron Industries, Inc." HYDROGEN PEROXID
E 2.65 mL/100mL
49580-0403_eec12ddd-ebf8-4e74-a819-721a7b7ae752 49580-0403 HUMAN OTC DRUG
Night Time Cherry Pseudo-Free NyQuil Cherry LIQUID ORAL 20091103
OTC MONOGRAPH FINAL part341 "Aaron Industries, Inc." ACETAMINOPHEN; D
EXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL;
mg/15mL; mg/15mL
49580-0408_d0b6356c-6332-4501-96a0-0483cc4a7f1f 49580-0408 HUMAN OTC DRUG
Childrens Acetaminophen Oral Suspension Grape Flavor Acetaminophen SUSPENSI
ndustries, Inc." ACETAMINOPHEN 160 mg/5mL
49580-0413_de00ae10-0462-49c0-b08c-63ca5a248462 49580-0413 HUMAN OTC DRUG
Tussin Original Robitussin LIQUID ORAL 20090116
OTC MONOGRAPH FINAL part341 "Aaron Industries, Inc." GUAIFENESIN
100 mg/5mL
49580-0413_fdc96293-f625-4b57-bb54-232485b820b3 49580-0413 HUMAN OTC DRUG
Tussin Original Robitussin LIQUID ORAL 20090116
OTC MONOGRAPH FINAL part341 "Aaron Industries, Inc." GUAIFENESIN
100 mg/5mL
49580-0434_11da15b6-7dd8-4e78-b0cb-bd3a41f6480f 49580-0434 HUMAN OTC DRUG
Tussin Sugar Free Cough Robitussin Sugar Free Cough LIQUID ORAL
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL
49580-0901_efe3165a-55c0-4cfa-baa9-eecd0a20fbe2 49580-0901 HUMAN OTC DRUG
Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20090714
OTC MONOGRAPH FINAL part333 "Aaron Industries, Inc." ISOPROPYL ALCOHO
L 50 mL/100mL
49580-0905_711d6363-f5df-467e-aee0-8a0ec47d5fb2 49580-0905 HUMAN OTC DRUG
Ethyl Rubbing Alcohol Ethyl Rubbing Alcohol LIQUID TOPICAL 20091003
OTC MONOGRAPH FINAL part333 "Aaron Industries, Inc." ALCOHOL 70
mL/100mL
49580-0911_624bded1-4875-40e3-8323-d231267dab44 49580-0911 HUMAN OTC DRUG
Iso-Blu Alcohol Isopropyl Alcohol LIQUID TOPICAL 20090402
OTC MONOGRAPH FINAL part333 "Aaron Industries, Inc." ISOPROPYL ALCOHO
L 50 mL/100mL
49580-1403_f251c128-c486-4c73-8533-5aa7ded1b786 49580-1403 HUMAN OTC DRUG
mg/15mL; mg/15mL
49580-1403_f6aee0bc-9fe4-432a-8664-8a2186163bcf 49580-1403 HUMAN OTC DRUG
mg/15mL; mg/15mL
49580-1406_5d701d5a-9b60-4fdc-a2d1-03451c87ad76 49580-1406 HUMAN OTC DRUG
Night Time Original Pseudo-Free "Acetaminophen, Dextromethorphan Hydrobr
HORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL
; mg/15mL
49580-1406_d4e6309a-fce8-481a-aad4-9a166ace457c 49580-1406 HUMAN OTC DRUG
; mg/15mL
49580-1417_b0eb9524-5c62-4687-a975-5c5e44570114 49580-1417 HUMAN OTC DRUG
Childrens Allergy Diphenhydramine Hydrochloride LIQUID ORAL
DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL
49580-1434_c4cf7956-bedb-44d0-99e9-b800b0b7d7e9 49580-1434 HUMAN OTC DRUG
Childrens Plus Multi-Symptom Cold Grape with PE Childrens Tylenol Plus Multi-Sym
ptom Cold SUSPENSION ORAL 20090101 OTC MONOGRAPH FI
NAL part341 "Aaron Industries, Inc." ACETAMINOPHEN; CHLORPHENIRAMINE
MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1;
5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL
49580-2004_1960fdd9-d353-431c-855a-d61b39a51a0d 49580-2004 HUMAN OTC DRUG
Flu Relief Therapy Night Time "Acetaminophen, DIPHENHYDRAMINE HYDROCHL
ORIDE, Phenylephrine Hydrochloride" LIQUID ORAL 20091001
IPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5
mg/15mL; mg/15mL; mg/15mL
49580-2104_18350107-ba14-4d3d-b496-8ddda803f640 49580-2104 HUMAN OTC DRUG
Flu Relief Therapy Day Time Theraflu Daytime LIQUID ORAL
325; 10; 5 mg/15mL; mg/15mL; mg/15mL
49580-2412_ff196a21-d157-46ae-9255-ed78664c7860 49580-2412 HUMAN OTC DRUG
Triacting Cough and Sore Throat Grape Triaminic Cough and Sore Throat
LIQUID ORAL 20090203 OTC MONOGRAPH FINAL part341 "Aaron I
ndustries, Inc." ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE 160; 7.5
mg/5mL; mg/5mL
49580-3104_38826d02-7d7f-4e84-bc07-0af8190dbb67 49580-3104 HUMAN OTC DRUG
Cough Relief Orange DEXTROMETHORPHAN HYDROBROMIDE LIQUID ORAL 20091121
OTC MONOGRAPH FINAL part341 "Aaron Industries, Inc." DEXTROMETHORPHAN
HYDROBROMIDE 15 mg/5mL
49580-3164_b688bd8f-2c22-4fed-8dbd-4f0ed85994eb 49580-3164 HUMAN OTC DRUG
Cough Relief Orange DEXTROMETHORPHAN HYDROBROMIDE LIQUID ORAL 20090713
OTC MONOGRAPH FINAL part341 "Aaron Industries, Inc." DEXTROMETHORPHAN
HYDROBROMIDE 15 mg/5mL
49580-3210_c8114fa8-938f-4df1-bd97-df5a2d8ef529 49580-3210 HUMAN OTC DRUG
49580-3304_f380662d-589c-4702-a188-cc23a8ac307b 49580-3304 HUMAN OTC DRUG
Childrens Mucus Relief Cough Cherry "DEXTROMETHORPHAN HYDROBROMIDE,
GUAIFENESIN" LIQUID ORAL 20090203 OTC MONOGRAPH FINAL
part341 "Aaron Industries, Inc." DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENES
IN 5; 100 mg/5mL; mg/5mL
49580-3414_bf9a43a4-0746-4b9b-91ea-b695f6f700a4 49580-3414 HUMAN OTC DRUG
Childrens Acetaminophen Oral Suspension Grape Flavor Acetaminophen SUSPENSI
ndustries, Inc." ACETAMINOPHEN 160 mg/5mL
49580-3416_f5047012-047f-4a7a-8902-385ce6c572ae 49580-3416 HUMAN OTC DRUG
Day Time with PE DayQuil LIQUID ORAL 20070102 OTC MONO
mg/15mL; mg/15mL
49580-3444_7aeb33fe-a73f-44d4-89a8-b272fd86f2d4 49580-3444 HUMAN OTC DRUG
Dye-Free Childrens Acetaminophen Grape Acetaminophen SUSPENSION
ORAL 20090623 OTC MONOGRAPH FINAL part341 "Aaron Industrie
s, Inc." ACETAMINOPHEN 160 mg/5mL
49580-4406_7e5e9ce5-3493-49d3-bc7e-101d20c64b65 49580-4406 HUMAN OTC DRUG
Sore Throat Spray Cherry Phenol LIQUID ORAL 20090801
OTC MONOGRAPH NOT FINAL part356 "Aaron Industries, Inc." PHENOL 1.5
g/100mL
49580-4506_b68cf57b-0fad-4520-880a-e5d8d1b007fe 49580-4506 HUMAN OTC DRUG
Phenol Sore Throat Spray LIQUID ORAL 20090801
OTC MONOGRAPH NOT FINAL part356 "Aaron Industries, Inc." PHENOL 1.5
g/100mL
59779-987_75926ad0-9a1b-421e-b886-faf8cb2e11c9 59779-987 HUMAN OTC DRUG
DiBromm DM "BROMPHENIRAMINE MALEATE , PHENYLEPHRINE HYDROCHLORIDE,
DEXTROMETHORPHAN HYDROBROMIDE," LIQUID ORAL 20090716 OTC MONO
GRAPH FINAL part341 "Aaron Industries, Inc." BROMPHENIRAMINE MALEATE;
DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 1; 5; 2.5
68276-004_fe6a7986-2443-4e19-a830-42b4aa604e13 68276-004 HUMAN OTC DRUG
Bouton Eye Wash Water RINSE OPHTHALMIC 20100115
OTC MONOGRAPH FINAL part349 Aaxis Pacific WATER 98.6 mL/100mL
68276-005_80984d7b-efbd-452b-aea4-8f1d83d5ee25 68276-005 HUMAN OTC DRUG
Salinaax Eye Wash and Skin Flush Water RINSE OPHTHALMIC 20110311
68276-006_60803d8a-3927-4e56-9af4-88221b9ebc3d 68276-006 HUMAN OTC DRUG
Salinaax Eye Wash Water RINSE OPHTHALMIC 20100618
52815-001_a1abc266-6ced-4d6b-abf6-e8284b6ea312 52815-001 HUMAN OTC DRUG
SoCalm External Analgesic Methyl Salicylate PATCH TOPICAL 20101231
OTC MONOGRAPH NOT FINAL part348 AB7 Industries METHYL SALICYLATE 10
mg/100mg
52815-121_6cbed70a-5c2a-4615-8513-b9f545cb7d41 52815-121 HUMAN OTC DRUG
soCALM Pain Relieving METHYL SALICYLATE PATCH TOPICAL 20110822
g/100g
52815-121_be3d78ca-ebef-4cb6-ba67-000abb6f6831 52815-121 HUMAN OTC DRUG
g/100g
52815-121_cad9d558-b16d-40c1-a782-3500b934d7c7 52815-121 HUMAN OTC DRUG
g/100g
52815-122_1c87a85f-e58b-4e5f-80f4-d5cc2851a0a6 52815-122 HUMAN OTC DRUG
g/100g
52815-122_d1c77449-a29c-410c-a8a4-fe267a4fe802 52815-122 HUMAN OTC DRUG
g/100g
52815-122_e3f0f3b1-b849-4a32-ada9-791e69f02523 52815-122 HUMAN OTC DRUG
g/100g
52815-123_669d3389-ed4d-4308-a766-20c7c21e5550 52815-123 HUMAN OTC DRUG
g/100g
52815-123_7ad4bf30-a421-4535-8635-1ae99898e353 52815-123 HUMAN OTC DRUG
g/100g
52815-123_87b343fc-6445-489c-82dd-6cd194ce7a1f 52815-123 HUMAN OTC DRUG
g/100g
52815-124_3c3d0bf4-ca13-489d-bbb2-0d7f05834c63 52815-124 HUMAN OTC DRUG
g/100g
52815-124_aa5f5e77-1b32-425e-af40-480ee32f27de 52815-124 HUMAN OTC DRUG
g/100g
52815-124_c0f3b212-6c7d-4ad4-b98e-a997f6686668 52815-124 HUMAN OTC DRUG
g/100g
52815-125_ab75d6db-dccc-4d60-bdad-1e6c91ab26be 52815-125 HUMAN OTC DRUG
g/100g
52815-125_cc2219ad-b10c-4678-a3cc-65a8207a8c02 52815-125 HUMAN OTC DRUG
g/100g
52815-125_dde9d43a-6026-4dd9-8e2e-6f7c1d9e4362 52815-125 HUMAN OTC DRUG
g/100g
20890-0020_6cc082b1-ae18-49ed-a51b-d1c5c28792ee 20890-0020 HUMAN OTC DRUG
Lander Polar Ice Menthol GEL TOPICAL 20101201 OTC MONO
GRAPH NOT FINAL part356 Abaco Partners LLC DBA Surefil MENTHOL 20 mg/g
68605-2001_f21b567e-7251-4ab4-ad90-bce91c9c721e 68605-2001 HUMAN OTC DRUG
END-ZIT SULFUR "LOTION, AUGMENTED" TOPICAL 20040420
OTC MONOGRAPH FINAL part333D "ABBE Laboratories, Inc." SULFUR
0.05 g/mL
0.05 g/g
0.05 g/g
0.05 g/g
0032-1101_f39b3f57-a20f-0dd8-2070-e87340ce6010 0032-1101 HUMAN PRESCRIPTI
ON DRUG Aceon Perindopril Erbumine TABLET ORAL 20101214
NDA NDA020184 "Abbott Products, Inc." PERINDOPRIL ERBUMINE 2
mg/1
mg/1
mg/1
49317-001_aa44f437-54e3-439e-9b2c-4d3ccf219854 49317-001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS Abbott Welding Supply OXYGEN 995 mL/L
50462-107_a3c86cb1-8bc6-4b16-8256-fe6e305acb75 50462-107 HUMAN OTC DRUG
Noble Lion Medicated Balm Methyl Salicylate and Menthol LINIMENT
TOPICAL 20120704 OTC MONOGRAPH FINAL part348 "ABBP (ARRINGTON
, BATTLE, BELL & PERRY), LLC" MENTHOL; METHYL SALICYLATE 14.5; 30
mL/100mL; mL/100mL
mL/100mL; mL/100mL
mL/100mL; mL/100mL
mL/100mL; mL/100mL
mL/100mL; mL/100mL
mL/100mL; mL/100mL
0032-1203_3885d979-489b-1335-2fe0-1c848c4bc061 0032-1203 HUMAN PRESCRIPTI
ON DRUG Creon Pancrelipase "CAPSULE, DELAYED RELEASE" ORAL
20100813 NDA NDA020725 AbbVie Inc. PANCRELIPASE AMY
LASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE 15000; 3000; 9500
[USP'U]/1; [USP'U]/1; [USP'U]/1
ON DRUG Creon Pancrelipase "CAPSULE, DELAYED RELEASE PELLETS"
ORAL 20100813 NDA NDA020725 AbbVie Inc. PANCRELI
PASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE 30000; 6000; 190
00 [USP'U]/1; [USP'U]/1; [USP'U]/1
000 [USP'U]/1; [USP'U]/1; [USP'U]/1
6000 [USP'U]/1; [USP'U]/1; [USP'U]/1
0032-1708_7f8185dd-b6bd-5056-3d49-1350058a5bbb 0032-1708 HUMAN PRESCRIPTI
ON DRUG Prometrium Progesterone CAPSULE ORAL 20100730
NDA NDA019781 AbbVie Inc. PROGESTERONE 100 mg/1 "Progest
erone [Chemical/Ingredient],Progesterone [EPC]"
0032-1711_7f8185dd-b6bd-5056-3d49-1350058a5bbb 0032-1711 HUMAN PRESCRIPTI
ON DRUG Prometrium Progesterone CAPSULE ORAL 20100730
NDA NDA019781 AbbVie Inc. PROGESTERONE 200 mg/1 "Progest
14000 [USP'U]/1; [USP'U]/1; [USP'U]/1
0051-0021_152cd664-8ede-40f7-25ee-74a00f025736 0051-0021 HUMAN PRESCRIPTI
ON DRUG Marinol Dronabinol CAPSULE ORAL 20100713
NDA NDA018651 AbbVie Inc. DRONABINOL 2.5 mg/1 "Cannabi
noid [EPC],Cannabinoids [Chemical/Ingredient]" CIII
NDA NDA018651 AbbVie Inc. DRONABINOL 5 mg/1 "Cannabi
NDA NDA018651 AbbVie Inc. DRONABINOL 10 mg/1 "Cannabi
0051-8425_f64ad502-27d0-0479-3386-2bb3e834bfac 0051-8425 HUMAN PRESCRIPTI
ON DRUG Androgel Testosterone GEL TRANSDERMAL 20110314
NDA NDA021015 AbbVie Inc. TESTOSTERONE 10 mg/g "Androge
n [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient]"
CIII
CIII
0051-8462_4bbe996e-4e5b-db04-9519-781aae34511a 0051-8462 HUMAN PRESCRIPTI
NDA NDA022309 AbbVie Inc. TESTOSTERONE 16.2 mg/g "Androge
CIII
CIII
0074-0522_67f816b1-bcb4-171d-3761-b2154995d99c 0074-0522 HUMAN PRESCRIPTI
ON DRUG Kaletra Lopinavir and Ritonavir "TABLET, FILM COATED" ORAL
20100618 NDA NDA021906 AbbVie Inc. LOPINAVIR; RITON
AVIR 100; 25 mg/1; mg/1 "HIV Protease Inhibitors [MoA],Protease Inhibito
r [EPC],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],HIV
Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors
[MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C19 Inducers [MoA],
Cytochrome P450 3A Inducers [MoA],P-Glycoprotein Inhibitors [MoA]"
0074-1040_e3fe41a1-c9f7-6c2d-5aed-0c1c41745ebb 0074-1040 HUMAN PRESCRIPTI
ON DRUG Survanta Beractant SUSPENSION ENDOTRACHEAL
19910701 NDA NDA020032 AbbVie Inc. BERACTANT
25 mg/mL "Alveolar Surface Tension Reduction [PE],Surfactant [EPC],Surfac
tant Activity [MoA]"
0074-1052_15ffacd8-aa9d-af40-e148-645bd60cc169 0074-1052 HUMAN PRESCRIPTI
ON DRUG Lupaneta Pack leuprolide acetate and norethindrone acetate
KIT 20130701 NDA NDA203696 AbbVie Inc.
0074-1053_46caf01d-0a39-e0d4-76e9-1ce207be4ddd 0074-1053 HUMAN PRESCRIPTI
ON DRUG Lupaneta Pack leuprolide acetate and norethindrone acetate
KIT 20130701 NDA NDA203696 AbbVie Inc.
0074-1564_df41b5ad-15ce-12d0-b1b2-fed61f0c7635 0074-1564 HUMAN PRESCRIPTI
ON DRUG Depacon Valproate Sodium INJECTION INTRAVENOUS
19961230 NDA NDA020593 AbbVie Inc. VALPROATE SODIUM
100 mg/mL "Anti-epileptic Agent [EPC],Decreased Central Nervous System Dis
organized Electrical Activity [PE],Mood Stabilizer [EPC]"
0074-1658_a6ac052c-cdd6-420c-f1a6-47ada2354c1a 0074-1658 HUMAN PRESCRIPTI
ON DRUG Zemplar Paricalcitol "INJECTION, SOLUTION" INTRAVENOUS
19980417 NDA NDA020819 AbbVie Inc. PARICALCITOL
5 ug/mL "Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC]"
0074-1940_b2157f1d-6964-cd20-a05e-c3d5bb75d37d 0074-1940 HUMAN PRESCRIPTI
ON DRUG Norvir Ritonavir SOLUTION ORAL 20100506
NDA NDA020659 AbbVie Inc. RITONAVIR 80 mg/mL "HIV Pro
tease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [M
oA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C19 Inducers [MoA],Cyt
ochrome P450 3A Inducers [MoA],P-Glycoprotein Inhibitors [MoA]"
0074-2108_1b54bb3f-ed23-244b-117a-bfb8d1c769b7 0074-2108 HUMAN PRESCRIPTI
ON DRUG Lupron Depot-PED leuprolide acetate KIT
19930416 NDA NDA020263 AbbVie Inc.
0074-2277_5e597799-b1e0-3f2c-d7b2-2a16a5c26e5f 0074-2277 HUMAN PRESCRIPTI
ON DRUG Vicoprofen Hydrocodone Bitartrate and Ibuprofen "TABLET,
COATED" ORAL 19970923 NDA NDA020716 AbbVie I
nc. HYDROCODONE BITARTRATE; IBUPROFEN 7.5; 200 mg/1; mg/1
"Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nons
teroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inf
lammatory Drug [EPC]" CIII
0074-2278_942fdd32-3f0a-14be-101d-14782bd82840 0074-2278 HUMAN PRESCRIPTI
ON DRUG Mavik Trandolapril TABLET ORAL 19960426
NDA NDA020528 AbbVie Inc. TRANDOLAPRIL 1 mg/1 "Angiote
nsin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors
[MoA]"
[MoA]"
[MoA]"
0074-2586_69651db8-0f37-f1bc-9e3a-087494e4a977 0074-2586 HUMAN PRESCRIPTI
ON DRUG Biaxin Clarithromycin "TABLET, FILM COATED" ORAL 19911031
NDA NDA050662 AbbVie Inc. CLARITHROMYCIN 500 mg/1 "Macroli
de Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhi
bitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
"
0074-3005_dd75ea29-aa0b-2d03-0817-ada4500fe3f6 0074-3005 HUMAN PRESCRIPTI
ON DRUG Advicor niacin and lovastatin "TABLET, EXTENDED RELEASE"
ORAL 20011217 NDA NDA021249 AbbVie Inc. LOVASTAT
IN; NIACIN 20; 500 mg/1; mg/1 "Nicotinic Acid [EPC],Nicotinic Acids [C
hemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA
Reductase Inhibitors [MoA]"
IN; NIACIN 20; 1000 mg/1; mg/1 "Nicotinic Acid [EPC],Nicotinic
Acids [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylgluta
ryl-CoA Reductase Inhibitors [MoA]"
IN; NIACIN 40; 1000 mg/1; mg/1 "Nicotinic Acid [EPC],Nicotinic
0074-3015_3181041b-cd07-d252-bd0d-953350a9d9ca 0074-3015 HUMAN PRESCRIPTI
ON DRUG Teveten HCT Eprosartan Mesylate and Hydrochlorothiazide
TABLET ORAL 20100524 NDA NDA021268 AbbVie Inc.
EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE 600; 12.5 mg/1; mg/1
"Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],I
ncreased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient]"
0074-3020_3181041b-cd07-d252-bd0d-953350a9d9ca 0074-3020 HUMAN PRESCRIPTI
ON DRUG Teveten HCT Eprosartan Mesylate and Hydrochlorothiazide
TABLET ORAL 20100524 NDA NDA021268 AbbVie Inc.
EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE 600; 25 mg/1; mg/1 "Angiote
nsin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased
Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient]"
0074-3023_f9e82b66-e278-7608-bdca-e17f27e84874 0074-3023 HUMAN PRESCRIPTI
ON DRUG K-Tab Potassium Chloride "TABLET, FILM COATED, EXTENDED R
ELEASE" ORAL 19800609 NDA NDA018279 AbbVie Inc.
POTASSIUM CHLORIDE 1500 mg/1 "Potassium Compounds [Chemical/Ingredien
t],Potassium Salt [EPC]"
0074-3025_f3076488-3dcf-7eae-051e-090a81caa565 0074-3025 HUMAN PRESCRIPTI
ON DRUG Teveten Eprosartan Mesylate TABLET ORAL 20100524
NDA NDA020738 AbbVie Inc. EPROSARTAN MESYLATE 400 mg/1
"Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]"
0074-3040_f3076488-3dcf-7eae-051e-090a81caa565 0074-3040 HUMAN PRESCRIPTI
ON DRUG Teveten Eprosartan Mesylate TABLET ORAL 20100524
NDA NDA020738 AbbVie Inc. EPROSARTAN MESYLATE 600 mg/1
0074-3041_96174190-ffb5-968b-c3c6-ac81ce5354ad 0074-3041 HUMAN PRESCRIPTI
ON DRUG Vicodin Hydrocodone Bitartrate and Acetaminophen TABLET
ORAL 20120910 ANDA ANDA040658 AbbVie Inc. ACETAMIN
OPHEN; HYDROCODONE BITARTRATE 300; 5 mg/1; mg/1 "Opioid Agonist [EPC],Op
ioid Agonists [MoA]" CIII
ON DRUG Vicodin ES Hydrocodone Bitartrate and Acetaminophen
TABLET ORAL 20120910 ANDA ANDA040556 AbbVie Inc.
ACETAMINOPHEN; HYDROCODONE BITARTRATE 300; 7.5 mg/1; mg/1 "Opioid
Agonist [EPC],Opioid Agonists [MoA]" CIII
0074-3045_0557bf97-d1a1-43e1-a519-51e3b67120f5 0074-3045 HUMAN PRESCRIPTI
ON DRUG Cardizem LA Diltiazem Hydrochloride "TABLET, EXTENDED RELEAS
E" ORAL 20101225 NDA NDA021392 AbbVie Inc.
DILTIAZEM HYDROCHLORIDE 120 mg/1 "Calcium Channel Antagonists [MoA],Calci
um Channel Blocker [EPC]"
ON DRUG Vicodin HP Hydrocodone Bitartrate and Acetaminophen
TABLET ORAL 20120910 ANDA ANDA040556 AbbVie Inc.
ACETAMINOPHEN; HYDROCODONE BITARTRATE 300; 10 mg/1; mg/1 "Opioid Agonist
[EPC],Opioid Agonists [MoA]" CIII
IN; NIACIN 20; 750 mg/1; mg/1 "Nicotinic Acid [EPC],Nicotinic Acids [C
hemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA
Reductase Inhibitors [MoA]"
0074-3074_e4e7ba51-0aa5-71c4-f257-88c3f59a31ab 0074-3074 HUMAN PRESCRIPTI
ON DRUG Niaspan Niacin "TABLET, FILM COATED, EXTENDED RELEASE" ORAL
20100629 NDA NDA020381 AbbVie Inc. NIACIN 500
mg/1 "Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient]"
ON DRUG Biaxin Clarithromycin "GRANULE, FOR SUSPENSION" ORAL
19931223 NDA NDA050698 AbbVie Inc. CLARITHROMYCIN
125 mg/5mL "Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],
Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glyco
protein Inhibitors [MoA]"
ON DRUG Biaxin Clarithromycin "TABLET, FILM COATED, EXTENDED RELEASE"
ORAL 20000303 NDA NDA050775 AbbVie Inc. CLARITHR
OMYCIN 500 mg/1 "Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingr
edient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA]
,P-Glycoprotein Inhibitors [MoA]"
ON DRUG Biaxin Clarithromycin "GRANULE, FOR SUSPENSION" ORAL
19931223 NDA NDA050698 AbbVie Inc. CLARITHROMYCIN
250 mg/5mL "Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],
0074-3197_b7168a94-a567-22b0-7ac3-60982b3a2edb 0074-3197 HUMAN PRESCRIPTI
ON DRUG Moderiba Ribavirin "TABLET, FILM COATED" ORAL
20140120 ANDA ANDA077456 AbbVie Inc. RIBAVIRIN
200 mg/1 "Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiv
iral [EPC]"
ON DRUG Moderiba Ribavirin KIT 20140120
ANDA ANDA077456 AbbVie Inc.
iral [EPC]"
ON DRUG Moderiba Ribavirin KIT 20140120
ANDA ANDA077456 AbbVie Inc.
iral [EPC]"
0074-3287_87a5f498-a58f-deec-247d-fb4d91e5eec3 0074-3287 HUMAN PRESCRIPTI
ON DRUG Tarka Trandolapril and Verapamil Hydrochloride "TABLET,
FILM COATED, EXTENDED RELEASE" ORAL 19961022 NDA NDA02059
1 AbbVie Inc. TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE 2; 180 mg/1; mg
/1 "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting En
zyme Inhibitors [MoA],Calcium Channel Antagonists [MoA],Calcium Channel Blocker
[EPC]"
[EPC]"
[EPC]"
[EPC]"
0074-3312_2c637fa7-6e1c-ee74-199d-089e8a90b10c 0074-3312 HUMAN PRESCRIPTI
ON DRUG Simcor Niacin and Simvastatin "TABLET, FILM COATED, EXTENDED R
NIACIN; SIMVASTATIN 500; 20 mg/1; mg/1 "Nicotinic Acid [EPC],Nicotinic
0074-3333_b2157f1d-6964-cd20-a05e-c3d5bb75d37d 0074-3333 HUMAN PRESCRIPTI
ON DRUG Norvir Ritonavir "TABLET, FILM COATED" ORAL 20100506
NDA NDA022417 AbbVie Inc. RITONAVIR 100 mg/1 "HIV Pro
0074-3346_3908b94f-cd09-92d2-a1ef-d3d2774b3ffd 0074-3346 HUMAN PRESCRIPTI
ON DRUG Lupron Depot leuprolide acetate KIT 19951222
NDA NDA020517 AbbVie Inc.
NDA NDA050662 AbbVie Inc. CLARITHROMYCIN 250 mg/1 "Macroli
de Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhi
bitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
"
NIACIN; SIMVASTATIN 1000; 20 mg/1; mg/1 "Nicotinic Acid [EPC],Ni
cotinic Acids [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymet
hylglutaryl-CoA Reductase Inhibitors [MoA]"
NIACIN; SIMVASTATIN 1000; 40 mg/1; mg/1 "Nicotinic Acid [EPC],Ni
cotinic Acids [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymet
hylglutaryl-CoA Reductase Inhibitors [MoA]"
0074-3641_c22160df-8f23-1eac-d9a4-462a78528ae4 0074-3641 HUMAN PRESCRIPTI
0074-3663_8918ce4d-b17f-7867-0e81-63404ed65513 0074-3663 HUMAN PRESCRIPTI
0074-3727_7ac06272-06f4-fbf2-d038-1dd57223c961 0074-3727 HUMAN PRESCRIPTI
ON DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724
NDA NDA021402 AbbVie Inc. LEVOTHYROXINE SODIUM 137 ug/1
"l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient]"
0074-3753_a587d651-288c-a08b-e786-268bce889f48 0074-3753 HUMAN PRESCRIPTI
ON DRUG Tridione Trimethadione "TABLET, CHEWABLE" ORAL
19460125 NDA NDA005856 AbbVie Inc. TRIMETHADIONE
150 mg/1 "Anti-epileptic Agent [EPC],Decreased Central Nervous System Dis
organized Electrical Activity [PE]"
0074-3797_d567f091-3867-2149-abf5-f5dc7c330b65 0074-3797 HUMAN PRESCRIPTI
ON DRUG Humira Adalimumab "INJECTION, SOLUTION" SUBCUTANEOUS
20021230 BLA BLA125057 AbbVie Inc. ADALIMUMAB
40 mg/.8mL "Tumor Necrosis Factor Blocker [EPC],Tumor Necrosis Factor Recep
tor Blocking Activity [MoA]"
ON DRUG Humira Adalimumab KIT 20110405
BLA BLA125057 AbbVie Inc.
0074-3826_4f530103-e50f-86a0-a1b5-47940436feac 0074-3826 HUMAN PRESCRIPTI
ON DRUG Depakote ER Divalproex Sodium "TABLET, EXTENDED RELEAS
DIVALPROEX SODIUM 250 mg/1 "Anti-epileptic Agent [EPC],Decreased Ce
ntral Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]
"
ON DRUG Kaletra Lopinavir and Ritonavir SOLUTION ORAL 20100618
NDA NDA021251 AbbVie Inc. LOPINAVIR; RITONAVIR 80; 20 mg/mL; m
g/mL "HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],P-Glycoprotein I
nhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],HIV Protease Inhibitors [MoA
],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2
D6 Inhibitors [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 3A Induc
ers [MoA],P-Glycoprotein Inhibitors [MoA]"
0074-4314_a5153b04-9325-e204-0fb7-7a5822ce45c9 0074-4314 HUMAN PRESCRIPTI
ON DRUG Zemplar Paricalcitol "CAPSULE, LIQUID FILLED" ORAL
2 ug/1 "Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC]"
0074-4378_d7108a58-e395-de4c-888b-feda73f63571 0074-4378 HUMAN PRESCRIPTI
ON DRUG Nimbex Cisatracurium besylate INJECTION INTRAVENOUS
20101209 NDA NDA020551 AbbVie Inc. CISATRACURIUM BE
SYLATE 2 mg/mL "Neuromuscular Nondepolarizing Blockade [PE],Nondepolari
zing Neuromuscular Blocker [EPC]"
ON DRUG Nimbex Cisatracurium Besylate INJECTION INTRAVENOUS
ON DRUG Nimbex Cisatracurium Besylate INJECTION INTRAVENOUS
0074-4456_21c3defe-2a5c-8652-a385-886df473db42 0074-4456 HUMAN PRESCRIPTI
ON DRUG Ultane Sevoflurane LIQUID RESPIRATORY (INHALATION)
19950607 NDA NDA020478 AbbVie Inc. SEVOFLURANE
250 mL/250mL "General Anesthesia [PE],General Anesthetic [EPC]"
0074-4456_8929502f-5ca1-1d42-17c1-39ef0f465372 0074-4456 HUMAN PRESCRIPTI
ON DRUG Ultane Sevoflurane LIQUID RESPIRATORY (INHALATION)
19950607 NDA NDA020478 AbbVie Inc. SEVOFLURANE
250 mL/250mL "General Anesthesia [PE],General Anesthetic [EPC]"
0074-4637_a6ac052c-cdd6-420c-f1a6-47ada2354c1a 0074-4637 HUMAN PRESCRIPTI
ON DRUG Zemplar Paricalcitol "INJECTION, SOLUTION" INTRAVENOUS
0074-5681_9a2aee74-4bf8-056d-c436-6ef3cd91f2e4 0074-5681 HUMAN PRESCRIPTI
ON DRUG Depakene Valproic Acid "CAPSULE, LIQUID FILLED"
ORAL 19780228 NDA NDA018081 AbbVie Inc. VALPROIC
ACID 250 mg/1 "Anti-epileptic Agent [EPC],Decreased Central Nervous Sy
stem Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]"
0074-5682_9a2aee74-4bf8-056d-c436-6ef3cd91f2e4 0074-5682 HUMAN PRESCRIPTI
ON DRUG Depakene Valproic Acid SOLUTION ORAL 19780228
NDA NDA018082 AbbVie Inc. VALPROIC ACID 250 mg/5mL "Anti-ep
ileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Act
ivity [PE],Mood Stabilizer [EPC]"
0074-6114_fb47e391-c074-9122-b799-09d7bba67e09 0074-6114 HUMAN PRESCRIPTI
ON DRUG Depakote Sprinkles Divalproex Sodium CAPSULE ORAL
19890912 NDA NDA019680 AbbVie Inc. DIVALPROEX SODIU
M 125 mg/1 "Anti-epileptic Agent [EPC],Decreased Central Nervous Sy
0074-6122_b04764d6-bddb-e056-53c5-bc9ec56eaf69 0074-6122 HUMAN PRESCRIPTI
ON DRUG Tricor Fenofibrate TABLET ORAL 20041105
NDA NDA021656 AbbVie Inc. FENOFIBRATE 48 mg/1 "Peroxis
ome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated
Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient]"
0074-6123_b04764d6-bddb-e056-53c5-bc9ec56eaf69 0074-6123 HUMAN PRESCRIPTI
NDA NDA021656 AbbVie Inc. FENOFIBRATE 145 mg/1 "Peroxis
0074-6212_ad8dfab4-1537-f1ec-9084-69b825c9503b 0074-6212 HUMAN PRESCRIPTI
ON DRUG Depakote Divalproex Sodium "TABLET, DELAYED RELEASE
" ORAL 19830310 NDA NDA018723 AbbVie Inc.
"
"
"
0074-6316_9b3590fe-1b63-4eda-89d4-6f48d31ad982 0074-6316 HUMAN PRESCRIPTI
ON DRUG Erythrocin Stearate Erythromycin Stearate "TABLET, FILM CO
ATED" ORAL 19640624 ANDA ANDA060359 AbbVie Inc.
ERYTHROMYCIN STEARATE 500 mg/1 "Decreased Sebaceous Gland Activity [PE]
,Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]"
0074-6463_cdebb8a6-1320-22bf-473d-8fd124869f3b 0074-6463 HUMAN PRESCRIPTI
ON DRUG Gengraf Cyclosporine CAPSULE ORAL 20100524
ANDA ANDA065003 AbbVie Inc. CYCLOSPORINE 25 mg/1 "Calcine
urin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P
450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]"
0074-6479_cdebb8a6-1320-22bf-473d-8fd124869f3b 0074-6479 HUMAN PRESCRIPTI
ON DRUG Gengraf Cyclosporine CAPSULE ORAL 20100524
ANDA ANDA065003 AbbVie Inc. CYCLOSPORINE 100 mg/1 "Calcine
0074-6633_648bce36-7cf3-7db8-c55c-8df73ffcc8d7 0074-6633 HUMAN PRESCRIPTI
ON DRUG Norvir Ritonavir CAPSULE ORAL 20100506
NDA NDA020945 AbbVie Inc. RITONAVIR 100 mg/1 "HIV Pro
ON DRUG Kaletra Lopinavir and Ritonavir "TABLET, FILM COATED" ORAL
20100618 NDA NDA021906 AbbVie Inc. LOPINAVIR; RITON
AVIR 200; 50 mg/1; mg/1 "HIV Protease Inhibitors [MoA],Protease Inhibito
r [EPC],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],HIV
Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors
[MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C19 Inducers [MoA],
Cytochrome P450 3A Inducers [MoA],P-Glycoprotein Inhibitors [MoA]"
0074-7126_4f530103-e50f-86a0-a1b5-47940436feac 0074-7126 HUMAN PRESCRIPTI
"
0074-7269_d56f80ea-c253-48c0-c380-1d5e34b4e100 0074-7269 HUMAN PRESCRIPTI
ON DRUG Gengraf Cyclosporine SOLUTION ORAL 20100525
ANDA ANDA065025 AbbVie Inc. CYCLOSPORINE 100 mg/mL "Calcine
0074-8110_05ce9cea-a32f-104c-d9b9-0a94f02f2413 0074-8110 HUMAN PRESCRIPTI
ON DRUG Calcijex Calcitriol "INJECTION, SOLUTION" INTRAVEN
OUS 20100601 NDA NDA018874 AbbVie Inc. CALCITRI
OL 1 ug/mL "Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog
[EPC]"
0074-9189_a40c536f-5b6b-f374-f40b-3d37548c4ce5 0074-9189 HUMAN PRESCRIPTI
ON DRUG Trilipix Fenofibric Acid "CAPSULE, DELAYED RELEASE"
ORAL 20081215 NDA NDA022224 AbbVie Inc. FENOFIBR
IC ACID 135 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC]
0074-9642_a40c536f-5b6b-f374-f40b-3d37548c4ce5 0074-9642 HUMAN PRESCRIPTI
ON DRUG Trilipix Fenofibric Acid "CAPSULE, DELAYED RELEASE"
ORAL 20081215 NDA NDA022224 AbbVie Inc. FENOFIBR
IC ACID 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC]
62257-012_53e30cc3-4653-427c-9564-a2b89b381a0f 62257-012 HUMAN OTC DRUG
1012 Antimicrobial CHLOROXYLENOL SOAP TOPICAL 20130501
OTC MONOGRAPH NOT FINAL part333E "ABC Compounding Co., Inc." CHLOROXY
LENOL 3 mg/mL
62257-014_e3f8a26b-2a48-45ee-9557-0cc750634a5d 62257-014 HUMAN OTC DRUG
1014 Foaming Antimicrobial TRICLOSAN SOAP TOPICAL 20130501
OTC MONOGRAPH NOT FINAL part333E "ABC Compounding Co., Inc." TRICLOSA
N 0.003 mg/mL
62257-160_cd68b297-8b56-469c-9f73-075338427fad 62257-160 HUMAN OTC DRUG
Lynx Antibacterial CHLOROXYLENOL SOAP TOPICAL 20060714
LENOL 3 mg/mL
62257-221_aea401ec-46a3-40a8-ad1a-b44ae050a640 62257-221 HUMAN OTC DRUG
Hand-Aid ALCOHOL GEL TOPICAL 20001218 OTC MONO
GRAPH NOT FINAL part333E "ABC Compounding Co., Inc." ALCOHOL 0.7
mL/mL
62257-363_febeb5b5-e67c-4775-b501-5476ea0d2d47 62257-363 HUMAN OTC DRUG
Cleanse CHLOROXYLENOL SOAP TOPICAL 20101101 OTC MONO
GRAPH NOT FINAL part333E "ABC Compounding Co., Inc." CHLOROXYLENOL
3 mg/mL
62257-364_674d7418-dbd9-4262-97de-4dd6bc3b82dc 62257-364 HUMAN OTC DRUG
Prevens TRICLOSAN SOAP TOPICAL 20101101 OTC MONO
GRAPH NOT FINAL part333E "ABC Compounding Co., Inc." TRICLOSAN
0.003 mL/mL
62257-365_133da4be-b4a0-433f-8b90-de9d6f7b6ec1 62257-365 HUMAN OTC DRUG
Sani-Silk ALCOHOL LOTION TOPICAL 20101101 OTC MONO
mL/mL
62257-366_068dc902-0e24-4026-8b25-607a1e66113f 62257-366 HUMAN OTC DRUG
Jade MENTHOL SOAP TOPICAL 20100801 UNAPPROVED DRUG
OTHER "ABC Compounding Co., Inc." MENTHOL 4 mg/mL
62257-367_9639e347-8a55-427d-b4c0-10d355523de0 62257-367 HUMAN OTC DRUG
Coral TRICLOSAN SOAP TOPICAL 20101101 OTC MONO
GRAPH NOT FINAL part333E "ABC Compounding Co., Inc." TRICLOSAN
0.003 mL/mL
62257-369_1fc9deff-6065-4a49-85ee-ffe30e039a09 62257-369 HUMAN OTC DRUG
Clean All ALCOHOL LIQUID TOPICAL 20101101 OTC MONO
mL/mL
62257-370_2ae6d037-a1ee-43dc-9838-152696a87d63 62257-370 HUMAN OTC DRUG
Clean BENZETHONIUM CHLORIDE LIQUID TOPICAL 20101101
OTC MONOGRAPH NOT FINAL part333E "ABC Compounding Co., Inc." BENZETHO
NIUM CHLORIDE 2 mg/mL
62257-512_945b7ec7-8cbd-4def-b49a-4da40c868b96 62257-512 HUMAN OTC DRUG
Handy Quat BENZALKONIUM CHLORIDE SOAP TOPICAL 19950515
OTC MONOGRAPH NOT FINAL part333 "ABC Compounding Co., Inc." BENZALKONIUM CHL
ORIDE; N-ALKYL ETHYLBENZYL DIMETHYL AMMONIUM CHLORIDE (C12-C14) 12.5; 12.5
mg/mL; mg/mL
62257-544_65af7578-814e-4f47-8da6-666f05ea4fd7 62257-544 HUMAN OTC DRUG
Palm CHLOROXYLENOL SOAP TOPICAL 19981221 OTC MONO
GRAPH NOT FINAL part333E "ABC Compounding Co., Inc." CHLOROXYLENOL
3 mg/mL
62257-575_c62e150a-15d7-4f8d-b58f-cf7f270f58a4 62257-575 HUMAN OTC DRUG
QS Plus BENZETHONIUM CHLORIDE LIQUID TOPICAL 20030630
OTC MONOGRAPH NOT FINAL part333 "ABC Compounding Co., Inc." BENZETHONIUM CHL
ORIDE 2 mg/mL
62257-576_c56831b4-2584-4aca-86b4-e1bb034c94f5 62257-576 HUMAN OTC DRUG
Foamy Mango TRICLOSAN SOAP TOPICAL 20030703
OTC MONOGRAPH NOT FINAL part333 "ABC Compounding Co., Inc." TRICLOSAN
0.003 mL/mL
62257-585_2b2fe544-a9d9-4471-9a9e-61c9f2a642ba 62257-585 HUMAN OTC DRUG
Fast ALCOHOL LIQUID TOPICAL 20071220 OTC MONOGRAPH NO
T FINAL part333 "ABC Compounding Co., Inc." ALCOHOL 0.7 mL/mL
62257-605_ed5ca57e-c210-4833-9369-32f76995404f 62257-605 HUMAN OTC DRUG
Alcogel ALCOHOL GEL TOPICAL 20070427 OTC MONOGRAPH NO
T FINAL part333E "ABC Compounding Co., Inc." ALCOHOL 0.7 mL/mL
62257-606_5a93284c-3db0-438b-8c47-979c3c0d5460 62257-606 HUMAN OTC DRUG
Hand-E XL ALCOHOL GEL TOPICAL 20050401 OTC MONO
mL/mL
62257-607_00451f0a-813b-477b-886c-93746029d5da 62257-607 HUMAN OTC DRUG
Hand Sanitizer ALCOHOL GEL TOPICAL 20060714 OTC MONO
mL/mL
62257-639_7e92a011-2402-4dbf-8021-ea8f77537354 62257-639 HUMAN OTC DRUG
Clean All ALCOHOL LIQUID TOPICAL 20101101 OTC MONO
mL/mL
62257-738_2df3c152-e659-4295-9c7e-7e123ab0070a 62257-738 HUMAN OTC DRUG
Sani-Spritz ALCOHOL LIQUID TOPICAL 20091031 OTC MONO
GRAPH NOT FINAL part333 "ABC Compounding Co., Inc." ALCOHOL 0.7 mL/mL
62257-770_c7b146c0-c19e-4420-81ab-de6a54c0f39c 62257-770 HUMAN OTC DRUG
Antibacterial CHLOROXYLENOL SOAP TOPICAL 20140409
LENOL 3 mg/mL
62257-773_90e3f8eb-e736-4923-b2cd-d884ead724bf 62257-773 HUMAN OTC DRUG
MediSoft ALCOHOL "AEROSOL, FOAM" TOPICAL 20090831
OTC MONOGRAPH NOT FINAL part333 "ABC Compounding Co., Inc." ALCOHOL 620
mg/g
62257-783_b4c5512f-bfbc-44c6-8944-409eed07be13 62257-783 HUMAN OTC DRUG
Hand Sanitizing Wipes ALCOHOL CLOTH TOPICAL 20090409
OTC MONOGRAPH NOT FINAL part333 "ABC Compounding Co., Inc." ALCOHOL 620
mg/g
62257-785_c6c49637-65eb-45f9-b867-85d048f5da52 62257-785 HUMAN OTC DRUG
QS Plus Hand Sanitizing Wipes BENZETHONIUM CHLORIDE CLOTH TOPICAL
20090409 OTC MONOGRAPH NOT FINAL part333 "ABC Compounding Co., In
c." BENZETHONIUM CHLORIDE 2 mg/g
62257-855_c0c1dbfd-4ec2-4fea-86cd-ae6314501194 62257-855 HUMAN OTC DRUG
Fast ALCOHOL LIQUID TOPICAL 20110401 OTC MONOGRAPH NO
62257-856_1723bd32-7ee9-4788-a442-9f6b6b1672df 62257-856 HUMAN OTC DRUG
Mousse Vite ALCOHOL LIQUID TOPICAL 20071220 OTC MONO
mL/mL
62257-938_1012ed5e-47c5-4b75-9467-8ec4b5a16f28 62257-938 HUMAN OTC DRUG
SoftSan ALCOHOL LOTION TOPICAL 20101201 OTC MONOGRAPH NO
62257-950_35b8d32f-4ac5-42ce-afc2-28b1ad4a91b1 62257-950 HUMAN OTC DRUG
Clear Choice Out of Sight CHLOROXYLENOL SOAP TOPICAL 20140409
LENOL 3 mg/mL
54118-7977_36da272b-ede3-4282-b0db-feebf6e9ccad 54118-7977 HUMAN OTC DRUG
Aller - Tox 11 "Adrenal, Allium cepa, Ambrosia artemisiaefolia"
SOLUTION/ DROPS ORAL 20121128 UNAPPROVED HOMEOPATHIC
"ABCO Laboratories, Inc" ADENOSINE TRIPHOSPHATE; AMBROSIA ARTEMISIIFOLIA;
ARSENIC TRIOXIDE; BEEF LIVER; BEEF LUNG; BOS TAURUS ADRENAL GLAND; BOS TAURUS M
ESENCHYME; COUMARIN; EUPHRASIA STRICTA; HISTAMINE; HYALURONIDASE; MENADIONE; ONI
ON; PHOSPHORUS; PIPERINE; PULSATILLA PRATENSIS; RUTIN; SCHOENOCAULON OFFICINALE
SEED; SULFUR 5; 3; 12; 5; 3; 3; 6; 6; 3; 6; 9; 5; 3; 12; 5; 12; 5; 3; 12
[hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [h
p_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_
X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]
/60mL
54118-7978_7f169fa8-7925-4baa-8fe1-644544b2a3a7 54118-7978 HUMAN OTC DRUG
Amoeba Tox "Adrenal, Amoeba nosodes, Artemisia absinthium" SOLUTION
/ DROPS ORAL 20121128 UNAPPROVED HOMEOPATHIC "ABCO La
boratories, Inc" ADENOSINE TRIPHOSPHATE; ALPINE STRAWBERRY; BAPTISIA TINC
TORIA; BOS TAURUS ADRENAL GLAND; BOS TAURUS MESENCHYME; BOS TAURUS SPLEEN; CAJUP
UT OIL; CAPSICUM; CEANOTHUS AMERICANUS LEAF; CHELONE GLABRA; CINCHONA OFFICINALI
S BARK; ENTAMOEBA HISTOLYTICA; GENTIANA LUTEA ROOT; GOLDENSEAL; LYCOPODIUM CLAVA
TUM SPORE; MAMMAL LIVER; QUASSIA AMARA WOOD; SENNA LEAF; STRYCHNOS NUX-VOMICA SE
ED; WORMWOOD 5; 3; 3; 6; 6; 5; 1; 3; 6; 3; 12; 30; 6; 3; 12; 5; 3; 3; 12; 6
p_C]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_
X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_Q]/60mL; [hp_X]/60mL; [hp_X]
/60mL; [hp_X]/60mL
54118-7993_838c7ad0-cfda-4c83-b035-28b17bad40d3 54118-7993 HUMAN OTC DRUG
HZ - Tox "Arsenicum album, Asclepias tuberus, ATP" SOLUTION
boratories, Inc" "ADENOSINE TRIPHOSPHATE; ARSENIC; ASCLEPIAS TUBEROSA FLO
WERING TOP; BAPTISIA TINCTORIA; BOS TAURUS LYMPH; BOS TAURUS MESENCHYME; BOS TAU
RUS SPLEEN; BOS TAURUS THYMUS; CALCIUM SULFATE ANHYDROUS; CAT'S CLAW; DAPHNE MEZ
EREUM BARK; HUMAN HERPESVIRUS 5; LOMATIUM DISSECTUM ROOT; RANUNCULUS BULBOSUS; S
TRYCHNOS NUX-VOMICA SEED; THUJA OCCIDENTALIS LEAF; THYROID, BOVINE; TOXICODENDRO
N PUBESCENS LEAF" 5; 3; 3; 3; 3; 6; 3; 5; 6; 1; 3; 30; 3; 3; 12; 12; 5; 6
p_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; 1/60mL; [hp_X]/60mL; [hp_X]/60
mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL
54118-5152_9e6cb155-bd12-4015-a549-2f2508d0134a 54118-5152 HUMAN OTC DRUG
Immune Support System "Penicillium notatum, Penicillium frequentans, A
conitum napellus, Colloidal silver" SPRAY NASAL 20121004
UNAPPROVED HOMEOPATHIC "ABCO Laboratories, Inc." ACONITUM NAPELLU
S; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM GLABRUM; SILVER
4; 4; 4; 6 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL
54118-7132_eaac1277-a56b-43a8-bffd-a038882b754f 54118-7132 HUMAN OTC DRUG
Oral HCG Homeopathic "Hypothalamus, Pituitary, Hepar Suis, Methyl B12
" SOLUTION/ DROPS ORAL 20140305 UNAPPROVED HOMEOPATHIC
"ABCO Laboratories, Inc." "7-KETO-DEHYDROEPIANDROSTERONE; ADENOSINE TRIPHO
SPHATE; BOS TAURUS HYPOTHALAMUS; BOS TAURUS PITUITARY GLAND; GAMBOGE; GENTIANA L
UTEA ROOT; GLUCAGON; GONADOTROPHIN, CHORIONIC; GRAPHITE; INSULIN HUMAN; LACTIC A
CID, L-; METHYLCOBALAMIN; PHYTOLACCA AMERICANA ROOT; PORK KIDNEY; PORK LIVER; SE
MECARPUS ANACARDIUM JUICE; STRYCHNOS NUX-VOMICA SEED" 30; 30; 6; 6; 12; 5; 30;
12; 12; 30; 3; 8; 3; 8; 8; 15; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [
hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_C]/59mL; [hp_X]/59mL; [hp
_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_C
]/59mL; [hp_X]/59mL
54118-7141_20983373-09f1-4a02-ae05-44fc0b377d25 54118-7141 HUMAN OTC DRUG
GlycoPan Tox "Argentium nitricum, Kali carbonicum, Glycirrhiza glabra
" SOLUTION/ DROPS ORAL 20130201 UNAPPROVED HOMEOPATHIC
"ABCO Laboratories, Inc." "ADENOSINE TRIPHOSPHATE; BOS TAURUS ADRENAL GLAN
D; BOS TAURUS MESENCHYME; BOS TAURUS PITUITARY GLAND; CHOLESTEROL; CHROMIUM; FEN
UGREEK SEED; GLYCYRRHIZA GLABRA; GYMNEMA SYLVESTRE LEAF; KIDNEY BEAN; LACTIC ACI
D, DL-; LYCOPODIUM CLAVATUM SPORE; MAMMAL LIVER; PHOSPHORIC ACID; POTASSIUM CARB
ONATE; RHUS AROMATICA ROOT BARK; SELENIUM; SILVER NITRATE; SKIM MILK; SUCROSE; S
US SCROFA PANCREAS; SYZYGIUM CUMINI SEED; THYROID, UNSPECIFIED; URANYL NITRATE H
EXAHYDRATE; ZINC" 5; 6; 6; 6; 7; 3; 3; 1; 1; 1; 3; 30; 6; 4; 9; 3; 9; 9; 6
; 6; 6; 1; 6; 30; 9 [hp_X]/60mL; [hp_C]/60mL; [hp_X]/60mL; [hp_C]/60mL; [hp_
C]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]
/60mL; [hp_X]/60mL; [hp_C]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/6
0mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_C]/60mL; [hp_X]/60mL; [hp_C]/60m
L; [hp_X]/60mL; [hp_X]/60mL
54118-7188_6cf55f5e-8527-44d5-a70e-4b57ba6e28a8 54118-7188 HUMAN OTC DRUG
HCG Plus "Human Chorionic Gonadotropin (HCG), Garcinia Cambogia,
Hypothalamus" SOLUTION/ DROPS ORAL 20140516 UNAPPROVED HOMEO
PATHIC "ABCO Laboratories, Inc." "ACETYLCARNITINE; AMERICAN GINSE
NG; ARGININE; CALCIUM ARSENATE; FUCUS VESICULOSUS; GLUTAMIC ACID; GONADOTROPHIN,
CHORIONIC; LEUCINE; ORNITHINE" 3; 6; 3; 6; 6; 6; 12; 6; 12 [hp_X]/60mL; [hp
_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X
]/60mL; [hp_X]/60mL
54118-7196_a155c3ab-8ab1-42be-b622-adfeb4aecabe 54118-7196 HUMAN OTC DRUG
Oral hCG Activator "Hypothalamus, Hepar Suis, Methyl B12, Renal Sui
s, Gambogia, Graphites" SOLUTION/ DROPS ORAL 20140305 UNAPPROV
ED HOMEOPATHIC "ABCO Laboratories, Inc." "7-KETO-DEHYDROEPIANDROS
TERONE; ADENOSINE TRIPHOSPHATE; ARGININE; BOS TAURUS HYPOTHALAMUS; BOS TAURUS PI
TUITARY GLAND; GAMBOGE; GENTIANA LUTEA ROOT; GLUCAGON; GRAPHITE; INSULIN PORK; L
ACTIC ACID, L-; LEVOCARNITINE; METHYLCOBALAMIN; PHENYLALANINE; PHYTOLACCA AMERIC
ANA ROOT; PORK KIDNEY; PORK LIVER; SEMECARPUS ANACARDIUM JUICE; STRYCHNOS NUX-VO
MICA SEED; THYROID, UNSPECIFIED; TRYPTOPHAN" 30; 30; 12; 6; 6; 12; 5; 30; 12;
30; 3; 12; 8; 12; 3; 8; 8; 15; 12; 3; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_C]
/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_C]/59mL; [hp_X]/59mL; [hp_X]/5
9mL; [hp_X]/59mL; [hp_X]/59mL; [hp_C]/59mL; [hp_X]/59mL; [hp_C]/59mL; [hp_X]/59m
L; [hp_X]/59mL; [hp_X]/59mL; [hp_C]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_C]/59mL
54118-7199_0cca253d-60c2-4d31-b7d6-0c296e941f9a 54118-7199 HUMAN OTC DRUG
Immune Support System "Penicillium Notatum, Penicillium Frequentans, A
conitum Napellus, Ferrum Phosphoricum" TABLET ORAL 20121001
UNAPPROVED HOMEOPATHIC "ABCO Laboratories, Inc." ACONITUM NAPELLU
S; FERROSOFERRIC PHOSPHATE; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIU
M GLABRUM 4; 6; 4; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
54118-7232_dc0a2e1f-4ae8-4c0f-8f12-a64b80c30789 54118-7232 HUMAN OTC DRUG
HCG Plus "Human Chorionic Gonadotropin (HCG), Garcinia Cambogia,
Hypothalamus" SOLUTION/ DROPS ORAL 20140405 UNAPPROVED HOMEO
PATHIC "ABCO Laboratories, Inc." "7-KETO-DEHYDROEPIANDROSTERONE;
AMMONIUM CARBONATE; BEEF KIDNEY; BOS TAURUS BRAIN; BOS TAURUS HYPOTHALAMUS; BOS
TAURUS PITUITARY GLAND; CALCIUM CARBONATE; CALCIUM FLUORIDE; FUCUS VESICULOSUS;
GARCINIA CAMBOGIA FRUIT; GELSEMIUM SEMPERVIRENS WHOLE; GLUCAGON; GONADOTROPHIN,
CHORIONIC; GRAPHITE; INSULIN HUMAN; LACTIC ACID, L-; METHYLCOBALAMIN; PHYTOLACCA
AMERICANA ROOT; PORK LIVER; PROTEUS INCONSTANS; SEMECARPUS ANACARDIUM JUICE; ST
RYCHNOS NUX-VOMICA SEED; SUS SCROFA PANCREAS; THYROID, UNSPECIFIED; TRIPE"
30; 6; 8; 8; 6; 12; 12; 6; 3; 12; 12; 30; 12; 12; 30; 30; 8; 12; 8; 30; 6; 12; 8
; 12; 8 [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/
60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60
mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL
; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL;
[hp_X]/60mL
54118-7967_1fedc888-9dc1-4971-baa0-46086be2b64c 54118-7967 HUMAN OTC DRUG
Lymph 1 Acute "Adrenal, Apis mellifica" SOLUTION/ DROPS ORAL
20110228 UNAPPROVED HOMEOPATHIC "ABCO Laboratories, Inc.
" "ADENOSINE TRIPHOSPHATE; APIS MELLIFERA; ARANEUS DIADEMATUS; ATROPA BELL
ADONNA; BOS TAURUS ADRENAL GLAND; BOS TAURUS HYPOTHALAMUS; BOS TAURUS PITUITARY
GLAND; CONIUM MACULATUM FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; FUMARIA OFFICINAL
IS FLOWERING TOP; GALIUM APARINE; GRAPHITE; LACHESIS MUTA VENOM; MARITIME PINE;
MERCUROUS IODIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PHYTOLACCA
AMERICANA ROOT; POTASSIUM IODIDE; SCROPHULARIA NODOSA; SULFUR; THYROID, BOVINE;
TOXICODENDRON PUBESCENS LEAF; UNCARIA TOMENTOSA LEAF; VESPA CRABRO; VIROLA SEBIF
ERA RESIN" 4; 3; 9; 6; 3; 3; 3; 6; 1; 6; 9; 6; 12; 6; 9; 9; 12; 2; 3; 9; 12
; 6; 12; 3; 12; 9 [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_
/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/6
0mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60m
L; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL
54118-7972_9baf9418-5173-409f-a624-eaee0c2fdef3 54118-7972 HUMAN OTC DRUG
Ultimate Rescue "Cherry Plum, Clematis, Impatiens, Rock rose, Star of Be
thlehem, ATP, Pineal, thymus" SOLUTION/ DROPS ORAL 20110228
UNAPPROVED HOMEOPATHIC "ABCO Laboratories, Inc." ADENOSINE TRIPHO
SPHATE; BOS TAURUS PINEAL GLAND; BOS TAURUS THYMUS; CHERRY PLUM; CISTUS INCANUS
WHOLE; CLEMATIS CHINENSIS ROOT; IMPATIENS BALSAMINA LEAF; ORNITHOGALUM UMBELLATU
M 5; 6; 6; 30; 30; 30; 30; 30 [hp_X]/60mL; [hp_C]/60mL; [hp_C]/60mL; [
hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL
54118-7976_f294fc3e-4d48-4774-a032-aac88ccd9edc 54118-7976 HUMAN OTC DRUG
Aller-Tox 1 "Acetaldehyde, Adrenal, Argentum Nitricum" SOLUTION
boratories, Inc." ACETALDEHYDE; ADENOSINE TRIPHOSPHATE; ARSENIC TRIOXIDE;
BERBERIS VULGARIS ROOT BARK; BOS TAURUS ADRENAL GLAND; BOS TAURUS MESENCHYME; CO
RTICOTROPIN; CORTISONE; GALLIC ACID MONOHYDRATE; HISTAMINE; HYALURONIDASE; HYDRA
NGEA ARBORESCENS ROOT; INTERFERON BETA-1A; LYCOPODIUM CLAVATUM SPORE; MAMMAL LIV
ER; SEROTONIN; SILVER NITRATE; STRYCHNOS NUX-VOMICA SEED 6; 5; 6; 30; 3;
6; 12; 6; 6; 6; 6; 6; 6; 12; 5; 6; 6; 12 [hp_X]/60mL; [hp_X]/60mL; [hp_X]
L; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL
54118-7979_4946546b-379a-4269-975f-2d96cf2b13b9 54118-7979 HUMAN OTC DRUG
Bacteria Tox "Adrenal, ATP, Bac nosode, Belladonna" SOLUTION/ DROPS
ORAL 20121130 UNAPPROVED HOMEOPATHIC "ABCO Laboratori
es, Inc." ADENOSINE TRIPHOSPHATE; ATROPA BELLADONNA; BEEF LIVER; BORRELIA
BURGDORFERI; BOS TAURUS ADRENAL GLAND; BOS TAURUS MESENCHYME; BOS TAURUS SPLEEN;
CROTALUS HORRIDUS HORRIDUS VENOM; GOLDENSEAL; HUMAN THYMUS; HYPERICUM PERFORATU
M; LOMATIUM DISSECTUM ROOT; MYCOBACTERIUM TUBERCULOSIS; MYRRH; NASTURTIUM OFFICI
NALE; PHOSPHORUS; TABEBUIA IMPETIGINOSA BARK 5; 6; 3; 12; 3; 6; 5; 12; 3; 5;
12; 3; 12; 3; 3; 12; 3 [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_
0mL
54118-7981_f2b2191b-d215-4ae4-b8d8-004ecec8ee83 54118-7981 HUMAN OTC DRUG
Chem - Tox "Adrenal, Arctium lappa, ATP, Belladonna, Chemical isode
s" SOLUTION/ DROPS ORAL 20121130 UNAPPROVED HOMEOPATHIC
"ABCO Laboratories, Inc." "ADENOSINE TRIPHOSPHATE; ARCTIUM LAPPA WHOLE; AR
SENIC TRIOXIDE; ATROPA BELLADONNA; BEEF KIDNEY; BEEF LIVER; BOS TAURUS ADRENAL G
LAND; BOS TAURUS LYMPH; BOS TAURUS MESENCHYME; ELYMUS REPENS ROOT; FRANGULA PURS
HIANA BARK; LICORICE; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; PHOSPHORIC ACID; P
HOSPHORUS; PHYTOLACCA AMERICANA ROOT; STRYCHNOS NUX-VOMICA SEED; THYROID, BOVINE
; TRIFOLIUM PRATENSE FLOWER" 5; 3; 12; 12; 3; 3; 5; 3; 6; 3; 3; 3; 12; 6; 6;
12; 3; 12; 5; 3 [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL;
[hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [
hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp
_X]/60mL; [hp_X]/60mL; [hp_X]/60mL
54118-7990_a6097ed7-2469-4dbf-b3d5-acf11dda0470 54118-7990 HUMAN OTC DRUG
Gyne - Tox "Adrenal, Angelica Atropurpurea, Boricum Acidum, ATP"
SOLUTION/ DROPS ORAL 20121219 UNAPPROVED HOMEOPATHIC
"ABCO Laboratories, Inc." "ADENOSINE TRIPHOSPHATE; ANEMONE NEMOROSA; ANGEL
ICA ATROPURPUREA ROOT; BLACK COHOSH; BORIC ACID; BOS TAURUS ADRENAL GLAND; BOS T
AURUS LYMPH; BOS TAURUS MESENCHYME; BOS TAURUS OVARY; BOS TAURUS PLACENTA; BOS T
AURUS UTERUS; CANDIDA ALBICANS; DELPHINIUM STAPHISAGRIA SEED; ESTRONE; GONORRHEA
L URETHRAL SECRETION HUMAN; MERCURIUS SOLUBILIS; SCABIES LESION LYSATE (HUMAN);
SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, UNSPECIFIED; TR
EPONEMIC SKIN CANKER HUMAN; WOOD CREOSOTE" 5; 12; 3; 3; 12; 6; 6; 6; 5; 5;
5; 6; 12; 30; 30; 12; 30; 12; 12; 6; 30; 12 [hp_X]/60mL; [hp_X]/60mL; [hp_X]
L; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL;
[hp_X]/60mL
54949-001_0b24b6a6-b51e-4c88-a98c-eb2f0ea35044 54949-001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS ABCO Welding and Industrial Supply Inc OXYGEN
995 mL/L
54949-002_75196dac-aea4-478a-9f4f-99795f72e091 54949-002 HUMAN PRESCRIPTI
19970812 UNAPPROVED MEDICAL GAS ABCO Welding and Industr
ial Supply Inc NITROGEN 990 mL/L
54949-004_c865e683-db22-4e55-9814-a93b6848daea 54949-004 HUMAN PRESCRIPTI
ON DRUG Carbon Dioxide Carbon Dioxide GAS RESPIRATORY (INHALATION)
ial Supply Inc CARBON DIOXIDE 990 mL/L "Radiographic Contrast Agent [EP
C],X-Ray Contrast Activity [MoA]"
54949-003_b827b4c7-d7ac-4373-aa49-d82141df1841 54949-003 HUMAN PRESCRIPTI
ON DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION)
ial Supply Inc. NITROUS OXIDE 990 mL/L
50809-001_54ea526f-516a-495e-84c8-3f9273d26637 50809-001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS Abilene Oxygen Inc. OXYGEN 99 L/100L
13733-001_2fdd6eb6-eac2-421f-bb89-3915ac84f052 13733-001 HUMAN OTC DRUG
MISSHA M WATERY B.B SPF 27 TITANIUM DIOXIDE CREAM CUTANEOUS
20080416 OTC MONOGRAPH FINAL part352 "ABLE C&C CO., LTD."
TITANIUM DIOXIDE 3.57 mL/50mL
13733-002_96d871b4-45b8-4e8f-be43-ad3daf881f85 13733-002 HUMAN OTC DRUG
MISSHA M PERFECT COVER BB SPF42 ZINC OXIDE CREAM CUTANEOUS
ZINC OXIDE 3.5 mL/50mL
13733-003_0f1f9ab4-b703-4dd9-9e36-a0c7dbfc3b9f 13733-003 HUMAN OTC DRUG
MISSHA M SHINY BB SPF27 TITANIUM DIOXIDE CREAM CUTANEOUS
13733-004_3dfb44a5-ba5c-4d90-a48b-05b3bf5bb92a 13733-004 HUMAN OTC DRUG
MISSHA M SIGNATURE RADIANCE FOUNDATION SPF20 TITANIUM DIOXIDE CREAM
CUTANEOUS 20090219 OTC MONOGRAPH FINAL part352 "ABLE C&
C CO., LTD." TITANIUM DIOXIDE 3.25 mL/35mL
13733-005_d0468086-4f2b-4808-9ae2-3f2cdb72c049 13733-005 HUMAN OTC DRUG
MISSHA M SIGNATURE RADIANCE TWO WAY PACT SPF27 TITANIUM DIOXIDE
POWDER CUTANEOUS 20090210 OTC MONOGRAPH FINAL part352
"ABLE C&C CO., LTD." TITANIUM DIOXIDE 0.98 g/11g
13733-006_649dd1c6-0300-4fcb-829a-430e9551b6bc 13733-006 HUMAN OTC DRUG
MISSHA M VITA BB SPF20 TITANIUM DIOXIDE CREAM CUTANEOUS
13733-010_17b5837d-7f6e-45be-a303-88a400155da6 13733-010 HUMAN OTC DRUG
MISSHA M SIGNATURE REAL COMPLETE BB SPF25 PA PLUS PLUS TITANIUM DIOXIDE
CREAM CUTANEOUS 20110601 OTC MONOGRAPH FINAL part352
"ABLE C&C CO., LTD." TITANIUM DIOXIDE; ZINC OXIDE 3.24; 1.71 g/45g; g
/45g
13733-011_61f0aebb-6289-490a-9819-45a1b436e819 13733-011 HUMAN OTC DRUG
MISA CHO BO YANG BB SPF30 PA PLUS PLUS NO.1 NATURAL BEIGE TITANIUM DIOXIDE
CREAM CUTANEOUS 20110601 OTC MONOGRAPH FINAL part352
"ABLE C&C CO., LTD." TITANIUM DIOXIDE; ZINC OXIDE 5.2; .7 mL/50mL; mL/50mL
13733-012_1178386a-35f8-4607-99d9-1dd14ae361c7 13733-012 HUMAN OTC DRUG
MISSHA M SWIRL BB SUN BALM SPF50 PLUS PA PLUS PLUS PLUS NO.21 TITANIUM
DIOXIDE CREAM CUTANEOUS 20110601 OTC MONOGRAPH FI
NAL part352 "ABLE C&C CO., LTD." TITANIUM DIOXIDE; ZINC OXIDE 4.46; 1.
44 g/20g; g/20g
13733-013_ec72eb63-1942-41c8-b8ea-f95b474d51c1 13733-013 HUMAN OTC DRUG
MISSHA SIGNATURE WRINKLE FILLER BB SPF37 PA PLUS PLUS NO.23 TITANIUM
DIOXIDE CREAM CUTANEOUS 20110601 OTC MONOGRAPH FI
NAL part352 "ABLE C&C CO., LTD." OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE
2.2; 4.268; 1.276 g/44g; g/44g; g/44g
13733-014_8b72633e-c1cd-4722-8c81-f82807e9605c 13733-014 HUMAN OTC DRUG
MISSHA ALL AROUND SAFE BLOCK ESSENCE SUN SPF45 PA PLUS PLUS PLUS OCTINOXA
TE CREAM CUTANEOUS 20110601 OTC MONOGRAPH FINAL
part352 "ABLE C&C CO., LTD." ENSULIZOLE; OCTINOXATE; OCTISALATE 2; 3.5;
2.4 mL/50mL; mL/50mL; mL/50mL
13733-015_7074f5d0-8e94-4d19-9f9c-edac53dfa435 13733-015 HUMAN OTC DRUG
MISSHA SIGNATURE DRAMATIC WHITENING PACT NO.2 SPF50 PLUS PA PLUS PLUS PLU
S "TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE" POWDER TOPICAL 20120301
OTC MONOGRAPH FINAL part352 "ABLE C&C CO., LTD." OCTINOXATE; TITANIUM DIO
XIDE; ZINC OXIDE .66; 1.84; .32 g/11g; g/11g; g/11g
13733-016_f2544331-3b7b-4777-9680-c6a8218dc300 13733-016 HUMAN OTC DRUG
MISSHA GLAM SILKY BODY BALM SPF 27 "Titanium Dioxide, OCTINOXATE, Zinc Oxid
e" CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part352
"ABLE C&C CO., LTD." OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.5; 1.8
8; .48 g/25g; g/25g; g/25g
13733-017_7d4f3728-9ac2-4b6c-9d24-5f22bb430dc9 13733-017 HUMAN OTC DRUG
MISSHA M PRISM BRIGHT ON AUTO NO.2 SPF35 PA PLUS PLUS PLUS "Titanium Dioxid
e, OCTINOXATE, Zinc Oxide" POWDER TOPICAL 20120301 OTC MONO
GRAPH FINAL part352 "ABLE C&C CO., LTD." OCTINOXATE; TITANIUM DIOXIDE; ZI
NC OXIDE .57; .81; .28 g/9.5g; g/9.5g; g/9.5g
13733-018_91c50152-9f70-4b21-9ea2-ea30e3ed365e 13733-018 HUMAN OTC DRUG
MISSHA SIGNATURE EXTREME COVER CONCEALER NO.23 SPF30 PA PLUS PLUS
Titanium Dioxide CREAM TOPICAL 20120301 OTC MONOGRAPH FI
NAL part352 "ABLE C&C CO., LTD." TITANIUM DIOXIDE 2.28 g/10g
13733-019_9246f162-13b9-430b-b416-dbf8fa8b87af 13733-019 HUMAN OTC DRUG
MISSHA TIME REVOLUTION WHITE CURE UV SUN PROTECTOR SPF50 PLUS PA PLUS PLUS
PLUS "ZINC OXIDE, OCTINOXATE, OCTISALATE" CREAM TOPICAL 20120301
OTC MONOGRAPH FINAL part352 "ABLE C&C CO., LTD." OCTINOXATE; OCTISALATE;
ZINC OXIDE 2.66; .76; 3.89 g/38g; g/38g; g/38g
13733-020_78e09168-48fd-4705-a55c-82d0dea65820 13733-020 HUMAN OTC DRUG
MISSHA ALL AROUND SAFE BLOCK ESSENCE SUN BROAD SPECTRUM SPF45 "OCTINOX
ATE, OCTISALATE, ENSULIZOLE" CREAM TOPICAL 20110601 OTC MONO
GRAPH NOT FINAL part352 "ABLE C&C CO., LTD." ENSULIZOLE; OCTINOXATE; OCTISALA
TE 2; 3.5; 2.4 mg/50mL; mg/50mL; mg/50mL
13733-030_d1d93232-f790-494f-bd75-aaa7f3ceb1c9 13733-030 HUMAN OTC DRUG
MISSHA ALL AROUND SAFE BLOCK SOFT FINISH SUN MILK BROAD SPECTRUM SPF 50 PL
US "OCTINOXATE, Zinc Oxide, Titanium Dioxide" CREAM TOPICAL 20130301
OTC MONOGRAPH NOT FINAL part352 "ABLE C&C CO., LTD." OCTINOXATE; TITANIUM DIO
XIDE; ZINC OXIDE 3; .87; 2.76 mg/40mL; mg/40mL; mg/40mL
13733-040_7cfc2977-2e19-4c38-b3fc-69b2c7013fcc 13733-040 HUMAN OTC DRUG
MISSHA SIGNATURE COMPLEXION COORDINATING BB BEIGE BROAD SPECTRUM SPF43
"Titanium Dioxide, OCTINOXATE, Zinc Oxide" CREAM TOPICAL 20130301
OTC MONOGRAPH NOT FINAL part352 "ABLE C&C CO., LTD." OCTINOXATE; TITANIUM DIO
XIDE; ZINC OXIDE 3.5; 4.96; 3.5 mg/50mL; mg/50mL; mg/50mL
13733-050_0424c9ce-6432-4ddf-bd28-46b4b473f5e3 13733-050 HUMAN OTC DRUG
MISSHA SIGNATURE COMPLEXION COORDINATING BB WHITE BROAD SPECTRUM SPF43
"Titanium Dioxide, OCTINOXATE, OCTISALATE, Zinc Oxide" CREAM TOPICAL 20130301
OTC MONOGRAPH NOT FINAL part352 "ABLE C&C CO., LTD." OCTINOXATE; OCTISALATE;
TITANIUM DIOXIDE; ZINC OXIDE 3.75; 2.5; 4.05; 2.45 mg/50mL; mg/50mL; mg/50m
L; mg/50mL
13733-060_44fe86ca-48a4-43cd-b96d-6504fcf9e527 13733-060 HUMAN OTC DRUG
MISSHA TIME REVOLUTION WHITE CURE BLANC SUN PROTECTOR NW BROAD SPECTRUM SPF50
PLUS "ZINC OXIDE, OCTINOXATE, OCTISALATE" CREAM TOPICAL 20130301
OTC MONOGRAPH NOT FINAL part352 "ABLE C&C CO., LTD." OCTINOXATE; OCTISALATE;
ZINC OXIDE 3.5; 1; 3.75 g/50g; g/50g; g/50g
13733-070_0d5bce0e-8022-4622-a5ad-58cd43f42fcc 13733-070 HUMAN OTC DRUG
MISSHA SIGNATURE COMPLEXION COORDINATING BB HONEY BEIGE "TITANIUM DIOXID
E, OCTINOXATE, ZINC OXIDE" CREAM TOPICAL 20131001 OTC MONO
GRAPH NOT FINAL part352 "ABLE C&C CO., LTD." OCTINOXATE; TITANIUM DIOXIDE; ZI
NC OXIDE 1.4; 1.55; 1.4 mg/20mL; mg/20mL; mg/20mL
13733-080_f799c721-ed8a-4188-8102-a4c73973a353 13733-080 HUMAN OTC DRUG
MISSHA M SIGNATURE REAL COMPLETE BB Honey Beige "Titanium Dioxide, Zinc
Oxide" CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352
"ABLE C&C Co., Ltd." TITANIUM DIOXIDE; ZINC OXIDE 3.47; 1.73 g/45g; g
/45g
63699-001_f7edf9f6-c3ac-4b15-b448-c919f102991b 63699-001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS "Ablecare Medical, Inc." OXYGEN 99
L/100L
68817-134_0c04a432-4622-11e3-8f96-0800200c9a66 68817-134 HUMAN PRESCRIPTI
ON DRUG ABRAXANE Paclitaxel "INJECTION, POWDER, LYOPHILIZED,
FOR SUSPENSION" INTRAVENOUS 20050210 NDA NDA02166
0 "Abraxis BioScience, LLC" PACLITAXEL 100 mg/20mL "Microtu
bule Inhibition [PE],Microtubule Inhibitor [EPC]"
18472-175_65ee60ad-1906-4d96-9fe8-0203e0890d46 18472-175 HUMAN OTC DRUG
Blue Ice Fermented Cod Liver Oil Calm Balm "Camphor, Menthol, Eucal
yptus Oil rub" SALVE TOPICAL 20110901 OTC MONOGRAPH NOT FINAL
part348 ABS Corporation CAMPHOR (NATURAL); EUCALYPTUS OIL; MENTHOL 1.3; 1.7
3; .37 g/49.5g; g/49.5g; g/49.5g
55636-590_4ae9e446-dfbe-4163-9a8b-7d75c1f501f4 55636-590 HUMAN OTC DRUG
Promescent Lidicaine SPRAY TOPICAL 20130111
OTC MONOGRAPH FINAL part348 Absorption LIDOCAINE 10 g/100g
42281-001_22afdb6f-8688-4eb6-b720-e7c8dc4ad56a 42281-001 HUMAN OTC DRUG
Belli Acne Control Spot Treatment SULFUR CREAM TOPICAL 20120102
OTC MONOGRAPH FINAL part333D ABT Belli-Materna Inc SULFUR 30
mg/mL
42281-003_6a47bdbd-d9e9-4905-8f5d-10e41e6e32d8 42281-003 HUMAN OTC DRUG
Belli Pure Radiance Facial Sunscreen Tinted Protection SPF 25 "TITANIU
M DIOXIDE, ZINC OXIDE" CREAM TOPICAL 20130722 OTC MONOGRAPH NO
T FINAL part352 ABT Belli-Materna Inc TITANIUM DIOXIDE; ZINC OXIDE 70; 50
mg/mL; mg/mL
59054-000_8025c0e7-fa99-4579-8139-f3201505960c 59054-000 HUMAN OTC DRUG
Academy Sports Outdoors SUNSCREEN CONTINUOUS SPORT BROAD SPECTRUM SPF 50 Water-R
esistant "AVOBENZONE, OCTOCRYLENE, OXYBENZONE" SPRAY TOPICAL
20130514 OTC MONOGRAPH NOT FINAL part352 Academy Ltd AVOBENZO
NE; OCTOCRYLENE; OXYBENZONE 30; 100; 50 mg/mL; mg/mL; mg/mL
59054-001_501d974d-9209-4b15-b20d-a200425ce525 59054-001 HUMAN OTC DRUG
Academy Sports Outdoors SUNSCREEN CONTINUOUS BROAD SPECTRUM SPF 50 Water-Resista
nt "AVOBENZONE, OCTOCRYLENE, OXYBENZONE" SPRAY TOPICAL 20130514
OTC MONOGRAPH NOT FINAL part352 Academy Ltd AVOBENZONE; OCTOCRYLENE; OXYBENZ
ONE 30; 100; 50 mg/mL; mg/mL; mg/mL
59054-110_a56e42d5-8c85-4553-93c5-a0572cebe45d 59054-110 HUMAN OTC DRUG
Academy Sport SPF 50 "AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBEN
ZONE" LOTION TOPICAL 20130628 OTC MONOGRAPH NOT FINAL part352
"ACADEMY, LTD" AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
3; 13; 5; 5; 6 g/100g; g/100g; g/100g; g/100g; g/100g
59054-120_7bbcdb59-052d-4c5f-acc4-71843139511b 59054-120 HUMAN OTC DRUG
Academy SPF 50 "AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE" LOTION
TOPICAL 20130628 OTC MONOGRAPH NOT FINAL part352 "ACADEMY, LTD"
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4
g/100g; g/100g; g/100g; g/100g; g/100g
59054-140_a9b2e101-4fed-4ed9-9050-ee7f20651612 59054-140 HUMAN OTC DRUG
Academy Continuous SPF 50 "AVOBENZONE, OCTOCRYLENE, OXYBENZONE" SPRAY
TOPICAL 20130830 OTC MONOGRAPH NOT FINAL part352 "ACADEMY, LTD"
AVOBENZONE; OCTOCRYLENE; OXYBENZONE 3; 10; 5 g/100g; g/100g; g/100g
59054-141_83a51487-6507-4e27-975b-7fc00e0a86fa 59054-141 HUMAN OTC DRUG
Academy Continuous Sport SPF 50 "AVOBENZONE, OCTOCRYLENE, OXYBENZONE"
SPRAY TOPICAL 20130827 OTC MONOGRAPH NOT FINAL part352 "ACADEMY
, LTD" AVOBENZONE; OCTOCRYLENE; OXYBENZONE 3; 10; 5 g/100g; g/100g;
g/100g
59054-370_1e15083c-59ad-4b55-a6d4-f51625e08cb4 59054-370 HUMAN OTC DRUG
Academy Sport SPF 30 "AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
" LOTION TOPICAL 20130628 OTC MONOGRAPH NOT FINAL part352
"ACADEMY, LTD" AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 10; 5; 10
g/100g; g/100g; g/100g; g/100g
10056-100_c22540e7-27f1-466b-b81a-02fc75f49f98 10056-100 HUMAN OTC DRUG
Artistry Hydrating Foundation SPF 20 UBV/UVA "ZINC OXIDE, OCTINOXATE"
CREAM TOPICAL 20110308 OTC MONOGRAPH NOT FINAL part352 Access B
usines Group LLC OCTINOXATE; ZINC OXIDE 7.5; 2 mL/100mL; mL/100mL
10056-134_4215a09f-f8ad-409d-b7be-914f08368863 10056-134 HUMAN OTC DRUG
Artistry Essentials Anti-Blemish Acne Treatment SALICYLIC ACID LOTION
TOPICAL 20110727 OTC MONOGRAPH NOT FINAL part333D Access B
usiness Group SALICYLIC ACID 1.1 mL/100mL
10056-161_0142f0f1-5e92-4eec-a53d-482b975c012e 10056-161 HUMAN OTC DRUG
Artistry Balancing Foundation "ZINC OXIDE, OCTINOXATE" LOTION
TOPICAL 20110727 OTC MONOGRAPH NOT FINAL part352 Access Business
Group OCTINOXATE; ZINC OXIDE 7.5; 2 mL/100mL; mL/100mL
10056-276_996fdb69-57e0-4b39-8d0c-1a65fbae0f10 10056-276 HUMAN OTC DRUG
Body Series Invisible Solid Deodorant and Antiperspirant Clean Scent
ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY CREAM TOPICAL 20110405
OTC MONOGRAPH FINAL part350 Access Business Group ALUMINUM ZIRCONIUM TRICH
LOROHYDREX GLY 17 g/100g
10056-135_6a7a09bb-45bb-4b8b-8a73-7279b6756271 10056-135 HUMAN OTC DRUG
QuickFlex Menthol CREAM TOPICAL 20100530 OTC MONO
GRAPH NOT FINAL part348 Access Business Group International LLC MENTHOL 1.25
g/100g
10056-271_8c6abcf3-0979-49bf-82a8-3a3a367bdfcc 10056-271 HUMAN OTC DRUG
FormuCare Ranitidine Ranitidine TABLET ORAL 20090909
ANDA ANDA076760 Access Business Group International LLC RANITIDINE HYDRO
CHLORIDE 75 mg/1
10056-329_c4c0b46b-d291-4f1c-9530-dcf748ac04d4 10056-329 HUMAN OTC DRUG
FormuCare Nasal Spray Original Oxymetazoline HCl SPRAY NASAL
20070710 OTC MONOGRAPH FINAL part341 Access Business Group In
ternational LLC OXYMETAZOLINE HYDROCHLORIDE 0.05 g/100mL
10056-368_07ce84c8-324c-4fc9-a8cc-14259d9a42a8 10056-368 HUMAN OTC DRUG
formucare naproxen sodium pain reliever fever reducer Naproxen Sodium
Access Business Group International LLC NAPROXEN SODIUM 220 mg/1
10056-535_453470ad-6629-493e-8ea8-713cc67ce989 10056-535 HUMAN OTC DRUG
FormuCare Aspirin Aspirin "TABLET, DELAYED RELEASE" ORAL
20060227 OTC MONOGRAPH NOT FINAL part343 Access Business Group In
ternational LLC ASPIRIN 81 mg/1
10056-700_d05f1836-0df0-41e5-b505-9e928741f012 10056-700 HUMAN OTC DRUG
Peter Island Sunscreen SPF 50 OCTOCRYLENE OXYBENZONE ZINC OXIDE LOTION
TOPICAL 20121120 OTC MONOGRAPH NOT FINAL part352 ACCESS BUSINESS
GROUP INTERNATIONAL LLC OCTOCRYLENE; OXYBENZONE; ZINC OXIDE 5; 2; 3.9
g/100g; g/100g; g/100g
10056-964_8c519f9b-5aa4-4a14-8504-f2b1075df3b1 10056-964 HUMAN OTC DRUG
formu care flu and severe cold and cough night time "Acetaminophen,
Diphenhydramine hydrochloride, Phenylephrine hydrochloride" "POWDER, FOR SOL
UTION" ORAL 20100914 OTC MONOGRAPH FINAL part341 Access B
usiness Group International LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PH
ENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1
10056-047_bd7e8ce0-ae3f-4e2d-82fb-340531eb0eb7 10056-047 HUMAN OTC DRUG
formu care ranitidine Ranitidine TABLET ORAL 20100924
ANDA ANDA078653 Access Business Group LLC RANITIDINE HYDROCHLORIDE
150 mg/1
10056-061_47f5310d-eb6c-4d3d-818e-25fdff841947 10056-061 HUMAN OTC DRUG
fulton street market nighttime flu and severe cold and cough "Acetami
nophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride" "POWDER,
FOR SOLUTION" ORAL 20100914 OTC MONOGRAPH FINAL part341
Access Business Group LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PH
10056-067_48ebece9-5deb-44c5-941f-3b7616cce8b7 10056-067 HUMAN OTC DRUG
Formucare Triple Antibiotic Original Strength "bacitracin, neomycin, p
olymyxin B" OINTMENT TOPICAL 20090821 OTC MONOGRAPH FI
NAL part333B Access Business Group LLC BACITRACIN; NEOMYCIN SUL
FATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g
10056-105_fcf45ba9-2848-4925-ab03-8a262863763c 10056-105 HUMAN OTC DRUG
fulton street market triple antibiotic original strength "bacitracin, neo
mycin, polymyxin B" OINTMENT TOPICAL 20090821 OTC MONO
GRAPH FINAL part333B Access Business Group LLC BACITRACIN; NEOM
YCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]
/g
10056-128_ed1c6b88-ebb6-4cb9-9469-33601a0c0649 10056-128 HUMAN OTC DRUG
Artistry Essentials Hydrating SPF 15 "OXYBENZONE, OCTINOXATE, ZINC OXIDE"
LOTION TOPICAL 20110413 OTC MONOGRAPH NOT FINAL part352 Access B
usiness Group LLC OCTINOXATE; OXYBENZONE; ZINC OXIDE 6.5; 2; 3.43
mL/100mL; mL/100mL; mL/100mL
10056-131_74a9ac39-653a-44c6-abb4-37198a6644a2 10056-131 HUMAN OTC DRUG
Artistry Essentials Balancing "OXYBENZONE, OCTINOXATE, ZINC OXIDE"
usiness Group LLC OCTINOXATE; OXYBENZONE; ZINC OXIDE 6.5; 2; 3.92
10056-175_a22594a2-1dbb-43cf-833e-5c371a091e30 10056-175 HUMAN OTC DRUG
Body Essentials Hand and Body Moisturizing Formula SPF 8 "OCTINOXATE, OXY
BENZONE" LOTION TOPICAL 20110413 OTC MONOGRAPH NOT FINAL
part352 Access Business Group LLC OCTINOXATE; OXYBENZONE 7; 3 mL/100mL
; mL/100mL
10056-179_69d7101b-3e96-4dba-9cf8-9c79dbd2691a 10056-179 HUMAN OTC DRUG
formu care calcium antacid Calcium carbonate "TABLET, CHEWABL
E" ORAL 20000611 OTC MONOGRAPH FINAL part331 Access B
usiness Group LLC CALCIUM CARBONATE 750 mg/1
10056-205_4266bb07-bd58-4d28-9d0f-591d0ad3e1ab 10056-205 HUMAN OTC DRUG
Formucare Athletes Foot Maximum Strength Tolnaftate SPRAY TOPICAL
20041111 OTC MONOGRAPH FINAL part333C Access Business
Group LLC TOLNAFTATE 1 g/100g
10056-300_7ac9457b-582e-4d92-a75e-8f3d387cc55f 10056-300 HUMAN OTC DRUG
Fulton Street Market pain relief extra strength Acetaminophen TABLET
ORAL 20050721 OTC MONOGRAPH NOT FINAL part343 Access Business
Group LLC ACETAMINOPHEN 500 mg/1
10056-306_2f689589-2a03-4907-ad26-6d5ea7b46caf 10056-306 HUMAN OTC DRUG
Fulton Street Market Clearlax Polyethylene Glycol 3350 "POWDER,
FOR SOLUTION" ORAL 20110811 ANDA ANDA090685 Access B
usiness Group LLC POLYETHYLENE GLYCOL 3350 17 g/17g
10056-359_f5bb290f-8319-47a4-9763-8c32e8d8b8d7 10056-359 HUMAN OTC DRUG
FormuCare Cough Syrup DM "Dextromethorphan Hydrobromide, Guaifene
sin" LIQUID ORAL 19980720 OTC MONOGRAPH FINAL part341
Access Business Group LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
10; 100 mg/5mL; mg/5mL
10056-400_54af4cbc-e49f-4c73-852e-d406ff2cb602 10056-400 HUMAN OTC DRUG
Fulton Street Market Naproxen Sodium Naproxen Sodium "TABLET, FILM CO
ATED" ORAL 20000706 ANDA ANDA074661 Access Business
Group LLC NAPROXEN SODIUM 220 mg/1
10056-430_cbff09ff-51ba-48bf-82d8-2d8e2515ae39 10056-430 HUMAN OTC DRUG
Formu Care pain reliever added strength "Acetaminophen, Aspirin, Caffein
e" "TABLET, FILM COATED" ORAL 19980720 OTC MONOGRAPH NO
T FINAL part343 Access Business Group LLC ACETAMINOPHEN; ASPIRIN; CAFFEINE
250; 250; 65 mg/1; mg/1; mg/1
10056-458_81a95e1b-e6e9-4e2c-92a1-ada14ba74975 10056-458 HUMAN OTC DRUG
Fulton Street Market Cetirizine Hydrochloride Cetirizine Hydrochloride
TABLET ORAL 20090701 ANDA ANDA078336 Access Business
Group LLC CETIRIZINE HYDROCHLORIDE 10 mg/1
10056-477_56356cd0-54dc-4010-a5c8-c3b8d92688c4 10056-477 HUMAN OTC DRUG
FORMUCARE FIBER LAXATIVE Calcium polycarbophil "TABLET, FILM CO
ATED" ORAL 20000727 OTC MONOGRAPH NOT FINAL part334 Access B
usiness Group LLC CALCIUM POLYCARBOPHIL 625 mg/1
10056-484_8968369b-e295-4cdb-9eac-2556e27d1cfe 10056-484 HUMAN OTC DRUG
Formu Care pain relief Acetaminophen TABLET ORAL 20050721
OTC MONOGRAPH NOT FINAL part343 Access Business Group LLC ACETAMINOPHEN
500 mg/1
10056-503_ae86efb2-1101-4873-9fab-09476beade30 10056-503 HUMAN OTC DRUG
laxative fiber Calcium polycarbophil "TABLET, FILM COATED" ORAL
20000727 OTC MONOGRAPH NOT FINAL part334 Access Business Group LL
C CALCIUM POLYCARBOPHIL 625 mg/1
10056-533_6cc9a7ba-855a-4b79-b4a4-ef27b7489488 10056-533 HUMAN OTC DRUG
fulton street market Athletes Foot Tolnaftate CREAM TOPICAL
20090814 OTC MONOGRAPH NOT FINAL part333C Access Business
Group LLC TOLNAFTATE 1 g/100g
10056-541_83a89dae-80d8-48e8-8724-ef338c0d919b 10056-541 HUMAN OTC DRUG
Formu Care Anti Itch maximum strength Hydrocortisone CREAM TOPICAL
20090812 OTC MONOGRAPH NOT FINAL part348 Access Business Group LL
C HYDROCORTISONE 1 g/100g
10056-557_8a7fc5f5-4840-4d45-9caf-5fb82348c31a 10056-557 HUMAN OTC DRUG
Fulton Street Market Ibuprofen Ibuprofen "TABLET, FILM COATED"
ORAL 19910115 ANDA ANDA072096 Access Business Group LL
C IBUPROFEN 200 mg/1
10056-604_d21649c7-dc1e-47aa-8ffa-565b8324d105 10056-604 HUMAN OTC DRUG
formu care ibuprofen Ibuprofen TABLET ORAL 19910115
ANDA ANDA072096 Access Business Group LLC IBUPROFEN 200
mg/1
10056-612_22f0346f-dc4b-430d-97c1-4ac3b4ef5618 10056-612 HUMAN OTC DRUG
FormuCare Allergy Relief Loratadine TABLET ORAL 20050127
ANDA ANDA076301 Access Business Group LLC LORATADINE 10
mg/1
10056-666_147d5f72-1e78-406f-b4aa-35ef6ed1e3ae 10056-666 HUMAN OTC DRUG
Fulton Street Market Omeprazole Omeprazole "TABLET, DELAYED RELEASE
" ORAL 20090708 NDA NDA022032 Access Business
Group LLC OMEPRAZOLE 20 mg/1
10056-699_2eeeb1c5-b277-42da-8fc4-d0feb401b273 10056-699 HUMAN OTC DRUG
Fulton Street Market Anti itch Hydrocortisone CREAM TOPICAL 20090812
OTC MONOGRAPH NOT FINAL part348 Access Business Group LLC HYDROCORTISONE
1 g/100g
10056-701_17e0c695-9b3b-4059-b74b-699f976ebc85 10056-701 HUMAN OTC DRUG
Peter Island Continuous Sport Sunscreen SPF 50 "HOMOSALATE, OXYBENZONE, OCTISAL
ATE, AVOBENZONE, OCTOCRYLENE" SPRAY TOPICAL 20130627 OTC MONO
GRAPH NOT FINAL part352 Access Business Group LLC AVOBENZONE; HOMOSALATE;
OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 5; 2; 6 g/100g; g/100g; g/100g;
g/100g; g/100g
10056-702_7538b626-5241-431d-87a9-ee3b90de32d6 10056-702 HUMAN OTC DRUG
Peter Island SunscreenSPF 50 SPF 50 "HOMOSALATE, OXYBENZONE, OCTISALATE, AVO
BENZONE, OCTOCRYLENE" LOTION TOPICAL 20130627 OTC MONOGRAPH NO
T FINAL part352 Access Business Group LLC AVOBENZONE; HOMOSALATE; OCTISALA
TE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 g/100g; g/100g; g/100g; g/100g;
g/100g
10056-704_e21eeba7-b3f9-44da-90da-9b86ed1e87a3 10056-704 HUMAN OTC DRUG
Peter Island Sunscreen SPF 70 "HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE,
OCTOCRYLENE" LOTION TOPICAL 20130628 OTC MONOGRAPH NOT FINAL
part352 Access Business Group LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTO
CRYLENE; OXYBENZONE 3; 15; 5; 10; 6 g/100g; g/100g; g/100g; g/100g; g/100g
10056-705_295f3a7c-6aaa-4590-beb9-2aa29f2149cf 10056-705 HUMAN OTC DRUG
10056-706_19074ee2-ff90-4503-a321-cda59d247638 10056-706 HUMAN OTC DRUG
Peter Island Baby Sunscreen SPF 50 "HOMOSALATE, OXYBENZONE, OCTISALATE, AVO
T FINAL part352 Access Business Group LLC AVOBENZONE; HOMOSALATE; OCTISALA
g/100g
10056-707_fe852b93-a70b-4af4-a0ee-0860a6279f3b 10056-707 HUMAN OTC DRUG
Peter Island Ultimate Sheer Dry Touch Sunscreen SPF 70 "HOMOSALATE, OXYBENZONE,
OCTISALATE, AVOBENZONE, OCTOCRYLENE" LOTION TOPICAL 20130628
OTC MONOGRAPH NOT FINAL part352 Access Business Group LLC AVOBENZONE; HOMO
SALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 5; 2.8; 6 g/100g;
g/100g; g/100g; g/100g; g/100g
10056-708_118f62aa-85b4-4032-9ce6-0e5ba6c16414 10056-708 HUMAN OTC DRUG
PETER ISLAND NATURAL MINERALSPF 60 SPF 60 TITANIUM DIOXIDE ZINC OXIDE
usiness Group LLC TITANIUM DIOXIDE; ZINC OXIDE 2.8; 4 g/100g; g/100g
10056-709_e24f1373-26a6-4256-a654-418a56a691f2 10056-709 HUMAN OTC DRUG
Peter Island Continous sunscreen SPF 50 "OXYBENZONE, AVOBENZONE, OCTOCRY
LENE" SPRAY TOPICAL 20130709 OTC MONOGRAPH NOT FINAL part352
Access Business Group LLC AVOBENZONE; OCTISALATE; OXYBENZONE 3; 5; 5
g/100g; g/100g; g/100g
10056-710_2c389c71-920b-4711-af22-26eb2cd168e3 10056-710 HUMAN OTC DRUG
Peter Island Continous sunscreen kids SPF 50 "OXYBENZONE, AVOBENZONE, OCTOCRY
LENE" SPRAY TOPICAL 20130709 OTC MONOGRAPH NOT FINAL part352
Access Business Group LLC AVOBENZONE; OCTISALATE; OXYBENZONE 3; 5; 5
g/100g; g/100g; g/100g
10056-711_54a41877-7106-4442-a228-1afd818ca525 10056-711 HUMAN OTC DRUG
Peter Island Continous sunscreen SPF 30 OCTOCRYLENE AVOBENZONE OCTISALAT
E HOMOSALATE LOTION TOPICAL 20130709 OTC MONOGRAPH NOT FINAL
CRYLENE 3; 10; 5; 10 g/100g; 1/100g; g/100g; g/100g
10056-872_f0ff3c56-5a7a-4aa3-a739-a5f80f458076 10056-872 HUMAN OTC DRUG
fulton street market night time cold and flu "Acetaminophen, Dextrome
thorphan HBr, Doxylamine succinate" LIQUID ORAL 20120822
OTC MONOGRAPH FINAL part341 Access Business Group LLC ACETAMINOPHEN; D
mg/30mL; mg/30mL
10056-897_9543b652-8d7c-40d2-bd93-e2020f79ce92 10056-897 HUMAN OTC DRUG
formu care ibuprofen childrens Ibuprofen SUSPENSION ORAL
19990119 ANDA ANDA074937 Access Business Group LLC
IBUPROFEN 100 mg/5mL
10056-903_c324dc52-e35b-4a60-a093-6c7ca5a97726 10056-903 HUMAN OTC DRUG
fulton street market cold "Acetaminophen, Chlorpheniramine Maleate
, Dextromethorphan HBr, Phenylephrine HCl" SUSPENSION ORAL 20100811
OTC MONOGRAPH FINAL part341 Access Business Group LLC ACETAMINOPHEN; C
HLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLOR
IDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL
10056-915_58e51d07-7378-4fd6-b337-bf7287f62e71 10056-915 HUMAN OTC DRUG
formu care omeprazole Omeprazole "TABLET, DELAYED RELEASE"
ORAL 20090708 NDA NDA022032 Access Business Group LL
C OMEPRAZOLE 20 mg/1
10056-990_1a2fdebc-0659-4216-abab-ce1f345ad0e0 10056-990 HUMAN OTC DRUG
Fulton Street Market cold and flu "acetaminophen, dextromethorphan
hydrobromide, doxylamine succinate" LIQUID ORAL 20100715
OTC MONOGRAPH FINAL part341 Access Business Group LLC ACETAMINOPHEN; D
mg/15mL; mg/15mL
10056-178_eae04a2e-02b2-4fe2-bbf7-8b73f3b0d09f 10056-178 HUMAN OTC DRUG
Body Series Deodorant and Antiperspirant Roll-On Regular Scent ALUMINUM
CHLOROHYDRATE LIQUID TOPICAL 20110411 OTC MONOGRAPH FINAL
part350 "Access Business Group, Inc." ALUMINUM CHLOROHYDRATE 25 mL/100mL
10056-060_07231126-be11-4718-bfe2-61e029737a7b 10056-060 HUMAN OTC DRUG
Satinique Dandruff Control Hair Cleanser PYRITHIONE ZINC SHAMPOO
TOPICAL 20110411 OTC MONOGRAPH FINAL part358H "Access
Business Group, LLC" PYRITHIONE ZINC 0.95 mL/100mL
10056-530_7be2b3d8-c34a-4750-8e04-d19b2f43e60f 10056-530 HUMAN OTC DRUG
Glister Multi-Action Fluoride Toothpaste SODIUM FLUORIDE "PASTE,
DENTIFRICE" TOPICAL 20110411 OTC MONOGRAPH FINAL part355
"Access Business Group, LLC" SODIUM FLUORIDE 0.21 g/100g
16729-001_976d77bc-201c-4797-897f-e1c4462997b2 16729-001 HUMAN PRESCRIPTI
ON DRUG Glimepiride Glimepiride TABLET ORAL 20070823
ANDA ANDA078181 Accord Healthcare Inc GLIMEPIRIDE 1 mg/1
"Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient]"
16729-023_7c295b64-ec39-42ec-9f02-da5b42e775e1 16729-023 HUMAN PRESCRIPTI
ON DRUG Bicalutamide Bicalutamide TABLET ORAL 20090706
ANDA ANDA078917 Accord Healthcare Inc BICALUTAMIDE 50 mg/1
"Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC]"
16729-108_5609c3f9-3a15-426a-b735-c2a988a31afe 16729-108 HUMAN PRESCRIPTI
ON DRUG Mitomycin Mitomycin "INJECTION, POWDER, LYOPHILIZED,
FOR SOLUTION" INTRAVENOUS 20090610 ANDA ANDA064144
Accord Healthcare Inc MITOMYCIN 20 mg/40mL "Alkylating Activity [Mo
A],Alkylating Drug [EPC]"
16729-246_f3041806-e608-47e0-89ae-3f4125c9ccfe 16729-246 HUMAN PRESCRIPTI
16729-247_e40c2556-f14f-4dc1-a152-89d584dc9ff9 16729-247 HUMAN PRESCRIPTI
16729-248_e40c2556-f14f-4dc1-a152-89d584dc9ff9 16729-248 HUMAN PRESCRIPTI
16729-019_b97af1be-8472-4462-ac16-4c316a03e471 16729-019 HUMAN PRESCRIPTI
ON DRUG Mycophenolate Mofetil Mycophenolate Mofetil TABLET ORAL
20090504 ANDA ANDA065416 Accord Healthcare Inc. MYCOPHEN
OLATE MOFETIL 500 mg/1 Antimetabolite Immunosuppressant [EPC]
16729-020_3fa16c19-b547-4586-9808-00208b56982e 16729-020 HUMAN PRESCRIPTI
ON DRUG Pioglitazone Hydrochloride pioglitazone hydrochloride
TABLET ORAL 20130213 ANDA ANDA200044 Accord Healthcar
e Inc. PIOGLITAZONE HYDROCHLORIDE 15 mg/1 "Peroxisome Proliferator
Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EP
C],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemica
l/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolid
inediones [Chemical/Ingredient]"
16729-029_00206aae-7db1-4ae9-8500-b03fd6788d74 16729-029 HUMAN PRESCRIPTI
ON DRUG Methyldopa Methyldopa "TABLET, FILM COATED" ORAL
20120627 ANDA ANDA070070 Accord Healthcare Inc. METHYLDO
PA 125 mg/1
PA 250 mg/1
PA 500 mg/1
16729-035_479e2f8b-054e-4bcb-b471-6688219ae188 16729-035 HUMAN PRESCRIPTI
ON DRUG Anastrozole Anastrozole TABLET ORAL 20100628
ANDA ANDA090568 Accord Healthcare Inc. ANASTROZOLE 1 mg/1
"Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA]"
16729-041_6816d5a4-1242-4601-bad8-3987de2ed4d7 16729-041 HUMAN PRESCRIPTI
ON DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20110615
ANDA ANDA091195 Accord Healthcare Inc. TACROLIMUS 0.5 mg/1
"Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA]"
ANDA ANDA091195 Accord Healthcare Inc. TACROLIMUS 1 mg/1
ANDA ANDA091195 Accord Healthcare Inc. TACROLIMUS 5 mg/1
16729-064_546dd170-2b0f-4224-9a56-9a0dbe49c48b 16729-064 HUMAN PRESCRIPTI
ON DRUG Levetiracetam levetiracetam "TABLET, FILM COATED" ORAL
20110314 ANDA ANDA090843 Accord Healthcare Inc. LEVETIRA
CETAM 250 mg/1 "Anti-epileptic Agent [EPC],Decreased Central Nervous Sy
stem Disorganized Electrical Activity [PE]"
16729-090_0ebfa7f9-a7f2-4da3-9f82-5e54313a6faa 16729-090 HUMAN PRESCRIPTI
ON DRUG Finasteride finasteride "TABLET, FILM COATED" ORAL
20100511 ANDA ANDA090121 Accord Healthcare Inc. FINASTER
IDE 5 mg/1 "5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inh
ibitors [MoA]"
16729-092_642ad9b5-fc42-4f81-a05b-2b6607a95590 16729-092 HUMAN PRESCRIPTI
ON DRUG Gemcitabine Hydrochloride Gemcitabine Hydrochloride
"INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION" INTRAVENOUS 20110725
ANDA ANDA091594 Accord Healthcare Inc. GEMCITABINE HYDROCHLORIDE
200 mg/5mL "Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic In
hibitor [EPC]"
16729-094_b97af1be-8472-4462-ac16-4c316a03e471 16729-094 HUMAN PRESCRIPTI
ON DRUG Mycophenolate Mofetil Mycophenolate Mofetil CAPSULE ORAL
20090504 ANDA ANDA090253 Accord Healthcare Inc. MYCOPHEN
16729-114_1128e14b-8081-4520-bb22-e0525b1ba3c4 16729-114 HUMAN PRESCRIPTI
ON DRUG Etoposide Etoposide INJECTION INTRAVENOUS
20130915 ANDA ANDA074513 Accord Healthcare Inc. ETOPOSID
E 20 mg/mL "Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors
[MoA]"
1 g/25mL "Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic In
hibitor [EPC]"
hibitor [EPC]"
16729-119_fb13016e-b627-486e-9efe-c17a59ade707 16729-119 HUMAN PRESCRIPTI
ON DRUG Montelukast Sodium Montelukast Sodium "TABLET, FILM CO
ATED" ORAL 20130115 ANDA ANDA202717 Accord Healthcar
e Inc. MONTELUKAST SODIUM 10 mg/1 "Leukotriene Receptor Antagonist
[EPC],Leukotriene Receptor Antagonists [MoA]"
16729-120_e2eff5cd-bf00-445c-9134-5e4a9d8e2c72 16729-120 HUMAN PRESCRIPTI
ON DRUG DOCETAXEL docetaxel KIT 20110630
NDA NDA201195 Accord Healthcare Inc.
16729-134_0e55897d-01cc-4c0b-8f90-d7781d00271d 16729-134 HUMAN PRESCRIPTI
ON DRUG Allopurinol allopurinol TABLET ORAL 20130902
ANDA ANDA203154 Accord Healthcare Inc. ALLOPURINOL 100 mg/1
"Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA]"
16729-135_0e55897d-01cc-4c0b-8f90-d7781d00271d 16729-135 HUMAN PRESCRIPTI
ON DRUG Allopurinol ALLOPURINOL TABLET ORAL 20130902
ANDA ANDA203154 Accord Healthcare Inc. ALLOPURINOL 300 mg/1
"Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA]"
16729-136_ebc11109-e7bf-452d-b675-4b3236d54164 16729-136 HUMAN PRESCRIPTI
ON DRUG Clonazepam clonazepam TABLET ORAL 20101124
ANDA ANDA077147 Accord Healthcare Inc. CLONAZEPAM 0.5 mg/1
"Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]" CIV
ANDA ANDA077147 Accord Healthcare Inc. CLONAZEPAM 1 mg/1
ANDA ANDA077147 Accord Healthcare Inc. CLONAZEPAM 2 mg/1
16729-139_5c536e87-9545-4582-ba15-5bf63c832d2a 16729-139 HUMAN PRESCRIPTI
ON DRUG Glipizide glipizide TABLET ORAL 20110301
ANDA ANDA074550 Accord Healthcare Inc. GLIPIZIDE 5 mg/1
16729-140_5c536e87-9545-4582-ba15-5bf63c832d2a 16729-140 HUMAN PRESCRIPTI
ON DRUG Glipizide glipizide TABLET ORAL 20110301
ANDA ANDA074550 Accord Healthcare Inc. GLIPIZIDE 10 mg/1
16729-145_72c7da07-d7db-4e91-bf4f-2039572e28f1 16729-145 HUMAN PRESCRIPTI
ON DRUG Quetiapine fumarate Quetiapine fumarate "TABLET, FILM CO
e Inc. QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC]
16729-151_a934d7f9-181f-4275-b120-a5958ec06603 16729-151 HUMAN PRESCRIPTI
ON DRUG topotecan hydrochloride topotecan hydrochloride "INJECTION, POWD
ER, LYOPHILIZED, FOR SOLUTION" INTRAVENOUS 20130701 ANDA
ANDA202351 Accord Healthcare Inc. TOPOTECAN HYDROCHLORIDE 4 mg/4mL
"Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA]"
16729-152_6191555d-eaa8-43a7-878e-7b8b87681637 16729-152 HUMAN PRESCRIPTI
ON DRUG Ramipril Ramipril CAPSULE ORAL 20140701
ANDA ANDA202392 Accord Healthcare Inc. RAMIPRIL 1.25 mg/1
"Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inh
ibitors [MoA]"
ANDA ANDA202392 Accord Healthcare Inc. RAMIPRIL 2.5 mg/1
ibitors [MoA]"
ANDA ANDA202392 Accord Healthcare Inc. RAMIPRIL 5 mg/1
ibitors [MoA]"
ANDA ANDA202392 Accord Healthcare Inc. RAMIPRIL 10 mg/1
ibitors [MoA]"
16729-168_b0fd9850-a24b-4a24-aedb-3c1fc159af71 16729-168 HUMAN PRESCRIPTI
ON DRUG Escitalopram Escitalopram "TABLET, FILM COATED" ORAL
20130115 ANDA ANDA202389 Accord Healthcare Inc. ESCITALO
PRAM OXALATE 5 mg/1 "Serotonin Reuptake Inhibitor [EPC],Serotonin Up
take Inhibitors [MoA]"
16729-179_84472fc8-ea7c-4c00-90e2-3697608caa23 16729-179 HUMAN PRESCRIPTI
ON DRUG AMLODIPINE BESYLATE Amlodipine besylate TABLET ORAL
20130701 ANDA ANDA202553 Accord Healthcare Inc. AMLODIPI
NE BESYLATE 2.5 mg/1 "Calcium Channel Antagonists [MoA],Dihydropyridi
ne Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient]"
NE BESYLATE 5 mg/1 "Calcium Channel Antagonists [MoA],Dihydropyridi
16729-182_babb1b20-fe82-40ba-8e7a-0c56fe433b4a 16729-182 HUMAN PRESCRIPTI
ON DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL
20130115 ANDA ANDA202556 Accord Healthcare Inc. HYDROCHL
OROTHIAZIDE 12.5 mg/1 "Increased Diuresis [PE],Thiazide Diuretic [EPC]
,Thiazides [Chemical/Ingredient]"
OROTHIAZIDE 25 mg/1 "Increased Diuresis [PE],Thiazide Diuretic [EPC]
16729-194_517f9a3d-4dc9-4148-a247-acbc342a7d00 16729-194 HUMAN PRESCRIPTI
ON DRUG LISINOPRIL Lisinopril TABLET ORAL 20130915
ANDA ANDA202554 Accord Healthcare Inc. LISINOPRIL 2.5 mg/1
ibitors [MoA]"
ANDA ANDA202554 Accord Healthcare Inc. LISINOPRIL 5 mg/1
ibitors [MoA]"
ibitors [MoA]"
ibitors [MoA]"
ibitors [MoA]"
ibitors [MoA]"
16729-218_3c0bf365-172f-4acb-b7f2-9ee1538545fc 16729-218 HUMAN PRESCRIPTI
ON DRUG Clopidogrel Clopidogrel bisulphate "TABLET, FILM COATED"
ORAL 20130515 ANDA ANDA202925 Accord Healthcare Inc.
CLOPIDOGREL BISULFATE 75 mg/1 "Decreased Platelet Aggregation [PE],P2Y
12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA]"
16729-219_3c0bf365-172f-4acb-b7f2-9ee1538545fc 16729-219 HUMAN PRESCRIPTI
ON DRUG Clopidogrel Clopidogrel bisulphate "TABLET, FILM COATED"
ORAL 20130515 ANDA ANDA202925 Accord Healthcare Inc.
ON DRUG DOCETAXEL docetaxel KIT 20110630
NDA NDA201195 Accord Healthcare Inc.
ON DRUG Docetaxel Docetaxel "INJECTION, SOLUTION" INTRAVEN
OUS 20120701 NDA NDA201195 Accord Healthcare Inc.
DOCETAXEL 20 mg/mL "Microtubule Inhibition [PE],Microtubule Inhibit
or [EPC]"
16729-262_cce459a9-a767-47ef-b1b8-84066c7cef49 16729-262 HUMAN PRESCRIPTI
ON DRUG Etoposide Etoposide INJECTION INTRAVENOUS
20130801 ANDA ANDA074513 Accord Healthcare Inc. ETOPOSID
E 20 mg/mL "Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors
[MoA]"
ON DRUG Docetaxel Docetaxel "INJECTION, SOLUTION" INTRAVEN
OUS 20130515 NDA NDA201195 Accord Healthcare Inc.
DOCETAXEL 20 mg/mL "Microtubule Inhibition [PE],Microtubule Inhibit
or [EPC]"
16729-004_6abd457b-66de-4590-9424-cd6dc8a67c62 16729-004 HUMAN PRESCRIPTI
ON DRUG simvastatin simvastatin "TABLET, FILM COATED" ORAL
20080226 ANDA ANDA078155 "Accord Healthcare, Inc."
SIMVASTATIN 10 mg/1 "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethyl
glutaryl-CoA Reductase Inhibitors [MoA]"
16729-034_94bdfa65-d1a7-4e70-a94a-ed157687b0c9 16729-034 HUMAN PRESCRIPTI
ON DRUG Letrozole letrozole "TABLET, FILM COATED" ORAL
LETROZOLE 2.5 mg/1 "Aromatase Inhibitor [EPC],Aromatase Inhibitors
[MoA]"
16729-078_f54d043d-1898-4834-925a-d19cd9cee2e4 16729-078 HUMAN PRESCRIPTI
ON DRUG CARBIDOPA AND LEVODOPA Carbidopa and Levodopa "TABLET, EXTENDE
D RELEASE" ORAL 20130509 ANDA ANDA202323 "Accord
Healthcare, Inc." CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 "Aromati
c Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA]
"
16729-079_f54d043d-1898-4834-925a-d19cd9cee2e4 16729-079 HUMAN PRESCRIPTI
ON DRUG CARBIDOPA AND LEVODOPA Carbidopa and Levodopa "TABLET, EXTENDE
D RELEASE" ORAL 20130509 ANDA ANDA202323 "Accord
Healthcare, Inc." CARBIDOPA; LEVODOPA 50; 200 mg/1; mg/1 "Aromati
"
16729-089_e055e9af-1b78-4acd-971e-a3a2cec6a8d5 16729-089 HUMAN PRESCRIPTI
ON DRUG Finasteride Finasteride "TABLET, FILM COATED" ORAL
FINASTERIDE 1 mg/1 "5-alpha Reductase Inhibitor [EPC],5-alpha Reduc
tase Inhibitors [MoA]"
16729-123_2e82418b-3175-4843-ab6b-86e6be3619ed 16729-123 HUMAN PRESCRIPTI
ON DRUG DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE "TABLET, FILM CO
ATED" ORAL 20111231 ANDA ANDA201335 "Accord Healthca
re, Inc." DONEPEZIL HYDROCHLORIDE 5 mg/1 "Cholinesterase Inhibito
r [EPC],Cholinesterase Inhibitors [MoA]"
16729-124_2e82418b-3175-4843-ab6b-86e6be3619ed 16729-124 HUMAN PRESCRIPTI
ON DRUG DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE "TABLET, FILM CO
ATED" ORAL 20111231 ANDA ANDA201335 "Accord Healthca
re, Inc." DONEPEZIL HYDROCHLORIDE 10 mg/1 "Cholinesterase Inhibito
16729-167_1b4dab43-23d9-4fee-a94c-c11749ad895a 16729-167 HUMAN PRESCRIPTI
ON DRUG Tramadol Tramadol Hydrochloride Tablets TABLET ORAL
TRAMADOL HYDROCHLORIDE 50 mg/1 "Full Opioid Agonists [MoA],Opioid Agoni
st [EPC]"
16729-276_33cef88a-1dc9-45a7-b178-d0195a8a80c3 16729-276 HUMAN PRESCRIPTI
ON DRUG Fluorouracil Fluorouracil "INJECTION, SOLUTION" INTRAVEN
OUS 20140201 ANDA ANDA040743 "Accord Healthcare, Inc.
" FLUOROURACIL 50 mg/mL "Nucleic Acid Synthesis Inhibitors [MoA]
,Nucleoside Metabolic Inhibitor [EPC]"
16729-276_e940e06c-c12f-45ad-a50e-cbb0123175c0 16729-276 HUMAN PRESCRIPTI
ON DRUG Fluorouracil Fluorouracil "INJECTION, SOLUTION" INTRAVEN
OUS 20140201 ANDA ANDA040798 "Accord Healthcare, Inc.
" FLUOROURACIL 50 mg/mL "Nucleic Acid Synthesis Inhibitors [MoA]
16729-277_ffb66c4a-52b1-4088-9a69-2a2cf2437a1c 16729-277 HUMAN PRESCRIPTI
ON DRUG Methotrexate Methotrexate INJECTION INTRA-ARTERIAL;
INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20140201 ANDA ANDA0407
16 "Accord Healthcare, Inc." METHOTREXATE 25 mg/mL "Folate
Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA]"
16729-081_49aa3d6d-2270-4615-aafa-b440859ab870 16729-081 HUMAN PRESCRIPTI
ON DRUG Naltrexone Hydrochloride Naltrexone Hydrochloride
"Accord Healthcare, Inc.," NALTREXONE HYDROCHLORIDE 50 mg/1
"Opioid Antagonist [EPC],Opioid Antagonists [MoA]"
17630-2000_3c007a4b-a0cb-4ab6-90e7-e564046c0475 17630-2000 HUMAN OTC DRUG
New Hawaiian Tropic Sensitive Skin Lotion Sunscreen Avobenzone and O
ctocrylene and Oxybenzone SPRAY TOPICAL 20091104 OTC MONO
GRAPH NOT FINAL part352 "Accra-Pac, Inc." AVOBENZONE; OCTOCRYLENE; OXYBENZ
ONE .03; .08; .06 g/g; g/g; g/g
17630-2001_d9c18759-a87f-481e-b69a-bbd7079d53f9 17630-2001 HUMAN OTC DRUG
Banana Boat Baby Tear Free Sunscreen SPF 60 Homosalate and Octinoxat
e and Octisalate and Avobenzone and Octocrylene SPRAY TOPICAL 20091022
OTC MONOGRAPH FINAL part352 "Accra-Pac, Inc." AVOBENZONE; HOMOSALATE;
OCTINOXATE; OCTISALATE; OCTOCRYLENE .03; .15; .075; .05; .024 mL/mL; m
L/mL; mL/mL; mL/mL; mL/mL
17630-2002_9f025323-11fe-4dd4-9624-2c4a03815ab9 17630-2002 HUMAN OTC DRUG
Banana Boat Kids Tear Free Sunscreen SPF 60 Homosalate and Octinoxat
e and Octisalate and Avobenzone and Octocrylene SPRAY TOPICAL 20091022
OCTINOXATE; OCTISALATE; OCTOCRYLENE .03; .15; .075; .05; .024 mL/mL; m
17630-2003_0086e81b-d038-47fa-9d83-782fc54a7c06 17630-2003 HUMAN OTC DRUG
Banana Boat UltraMist Baby Tear Free Continuous SPF 50 Avobenzone and H
omosalate and Octinoxate and Octisalate and Octocrylene SPRAY TOPICAL 20091022
OCTINOXATE; OCTISALATE; OCTOCRYLENE .03; .15; .075; .05; .024 g/g; g/g
; g/g; g/g; g/g
17630-2004_7c7eff48-33f8-4279-a8d2-67988618b4b0 17630-2004 HUMAN OTC DRUG
Banana Boat Kids Tear Free Continuous SPF 50 Avobenzone and Homosalat
e and Octinoxate and Octisalate and Octocrylene SPRAY TOPICAL 20091022
OCTINOXATE; OCTISALATE; OCTOCRYLENE .03; .15; .075; .05; .024 g/g; g/g
; g/g; g/g; g/g
17630-2005_9d1cd011-8b7f-4167-8a70-5a6cd917af82 17630-2005 HUMAN OTC DRUG
Banana Boat Sport Performance SPF 15 Avobenzone and Homosalate and Oc
tinoxate and Octisalate and Octocrylene and Oxybenzone SPRAY TOPICAL 20061202
OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .05; .05; .05; .025; .02
mL/mL; mL/mL; mL/mL; mL/mL; mL/mL; mL/mL
17630-2006_f665b5cc-971a-42d4-a47b-b91e69d5ab72 17630-2006 HUMAN OTC DRUG
Banana Boat Baby Tear Free Lotion SPF 50 Homosalate and Octinoxat
e and Octisalate and Octocrylene and Avobenzone SPRAY TOPICAL 20090723
OCTINOXATE; OCTISALATE; OCTOCRYLENE .03; .1; .075; .05; .05 mL/mL; mL/mL; mL
/mL; mL/mL; mL/mL
17630-2007_7902a1cb-8398-4127-8feb-3270158cabed 17630-2007 HUMAN OTC DRUG
Banana Boat UltraMist Kids Tear Free Lotion SPF 50 Homosalate and O
ctinoxate and Octisalate and Octocrylene and Avobenzone SPRAY TOPICAL 20090723
/mL; mL/mL; mL/mL
17630-2008_615baf42-a82b-404d-a778-6099a96f4172 17630-2008 HUMAN OTC DRUG
Banana Boat UltraMist Kids SPF 50 Factor de Proteccion Solar 50 Homosala
te and Octinoxate and Octisalate and Octocrylene and Avobenzone SPRAY TOPICAL
20090723 OTC MONOGRAPH FINAL part352 "Accra-Pac, Inc."
AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE .03; .1; .075; .
05; .05 mL/mL; mL/mL; mL/mL; mL/mL; mL/mL
17630-2009_1f44e8e0-2175-45c3-9bd3-61aac7fa7f58 17630-2009 HUMAN OTC DRUG
Banana Boat Kids Sin Lagrimas Pump SPF 50 Homosalate and Octinoxat
/mL; mL/mL; mL/mL
17630-2010_a602e76c-9dbe-491a-abe9-4178d1257ea8 17630-2010 HUMAN OTC DRUG
Banana Boat Baby Sin Lagrimas SPF 50 Pump Homosalate and Octinoxat
/mL; mL/mL; mL/mL
17630-2011_00b22981-e6f4-43d7-a37e-a7d8ccf73a9b 17630-2011 HUMAN OTC DRUG
Banana Boat Kids UltraMist Tear Free SPF 30 Avobenzone and Homosalat
e and Octisalate and Octocrylene SPRAY TOPICAL 20080618
OCTISALATE; OCTOCRYLENE .03; .15; .05; .025 g/g; g/g; g/g; g/g
17630-2012_c6c46da9-5c2d-4af5-a183-4c3627b93e5c 17630-2012 HUMAN OTC DRUG
Banana Boat Protective Dry SPF 10 Homosalate and Octisalate and Oc
tocrylene and Avobenzone OIL TOPICAL 20090701 OTC MONO
GRAPH FINAL part352 "Accra-Pac, Inc." AVOBENZONE; HOMOSALATE; OCTISALA
TE; OCTOCRYLENE .015; .06; .06; .025 mL/mL; mL/mL; mL/mL; mL/mL
17630-2013_9bdf3d53-69c7-42f5-b5e8-21cbcdc40eee 17630-2013 HUMAN OTC DRUG
Hawaiian Tropic Tanning Dry SPF 6 Avobenzone and Octocrylene and O
xybenzone OIL TOPICAL 20090520 OTC MONOGRAPH FINAL
part352 "Accra-Pac, Inc." AVOBENZONE; OCTOCRYLENE; OXYBENZONE .005; .0
35; .015 mL/mL; mL/mL; mL/mL
17630-2014_635e6e02-0003-42ef-882f-01df2ec0f540 17630-2014 HUMAN OTC DRUG
Banana Boat Sport Performance SPF 85 Avobenzone and Homosalate and Oc
tocrylene and Oxybenzone SPRAY TOPICAL 20090601 OTC MONO
GRAPH FINAL part352 "Accra-Pac, Inc." AVOBENZONE; HOMOSALATE; OCTOCRYL
ENE; OXYBENZONE .03; .15; .1; .06 mL/mL; mL/mL; mL/mL; mL/mL
17630-2015_901b758c-9233-4d40-ac15-64487d1ceaca 17630-2015 HUMAN OTC DRUG
Banana Boat Ultra Defense SPF 85 Avobenzone and Homosalate and Oc
tocrylene and Oxybenzone SPRAY TOPICAL 20090601 OTC MONO
GRAPH FINAL part352 "Accra-Pac, Inc." AVOBENZONE; HOMOSALATE; OCTOCRYL
ENE; OXYBENZONE .03; .15; .1; .06 mL/mL; mL/mL; mL/mL; mL/mL
17630-2016_ed38ed68-00e7-4b46-8f04-893bb4e9f4a9 17630-2016 HUMAN OTC DRUG
Banana Boat Kids Protect and Play SPF 85 Avobenzone and Homosalat
e and Octocrylene and Oxybenzone SPRAY TOPICAL 20090601
OCTOCRYLENE; OXYBENZONE .03; .15; .1; .06 mL/mL; mL/mL; mL/mL; mL/mL
17630-2017_d2e595d9-629c-4d9d-add3-e9c0d237b8ae 17630-2017 HUMAN OTC DRUG
Banana Boat Protective Dry SPF 15 Avobenzone and Octocrylene and O
; .03 mL/mL; mL/mL; mL/mL
17630-2018_2c23f218-5b62-4fee-a22a-b3f043c17ec1 17630-2018 HUMAN OTC DRUG
Banana Boat Deep Tanning Dry SPF 8 Avobenzone and Octocrylene and O
17630-2019_8765dc76-e236-49e9-a99c-de6d2da684b7 17630-2019 HUMAN OTC DRUG
Banana Boat Deep Tanning Dry SPF 4 Avobenzone and Octocrylene and O
17630-2020_6704904c-0a25-438d-bebe-f1f10ad01672 17630-2020 HUMAN OTC DRUG
Banana Boat Sport Body and Scalp SPF 30 Homosalate and Octinoxate and Oc
tisalate and Octocrylene and Oxybenzone and Avobenzone LOTION TOPICAL 20090609
17630-2021_f497ea15-b04b-4dab-b492-4dcf2f28bfc2 17630-2021 HUMAN OTC DRUG
Banana Boat Sport SPF 30 Homosalate and Octinoxate and Octisalate
and Octocrylene and Oxybenzone and Avobenzone SPRAY TOPICAL 20090609
17630-2022_fa29e200-6cd5-459e-858d-c04045d0ab04 17630-2022 HUMAN OTC DRUG
Banana Boat Ultra Defence SPF 30 for UK Homosalate and Octinoxate and Oc
tisalate and Octocrylene and Oxybenzone and Avobenzone SPRAY TOPICAL 20090609
17630-2023_be23fe01-6d34-422a-b7be-33de1c8e4221 17630-2023 HUMAN OTC DRUG
Banana Boat Ultra Defense SPF 30 for LATAM Homosalate and Octinoxat
e and Octisalate and Octocrylene and Oxybenzone and Avobenzone SPRAY TOPICAL
AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .08
78; .05; .05; .025; .05 mL/mL; mL/mL; mL/mL; mL/mL; mL/mL; mL/mL
17630-2024_5a121d3c-63ea-4574-a5b5-a7eee3eb6a26 17630-2024 HUMAN OTC DRUG
Banana Boat Ultramist Sport Performance SPF 50 Octocrylene and Avobenzo
ne and Octisalate and Oxybenzone and Octinoxate and Homosalate SPRAY TOPICAL
17630-2025_ed658d67-77fd-4101-ae80-b31a4cf6b4d8 17630-2025 HUMAN OTC DRUG
Banana Boat Aceite Bronceador Seco Tanning Dry SPF 6 Homosalate and O
ctisalate and Octocrylene and Avobenzone OIL TOPICAL 20090403
OCTISALATE; OCTOCRYLENE .01; .04; .04; .025 mL/mL; mL/mL; mL/mL; mL/mL
17630-2026_9fdfa6f7-504a-4b57-8db1-e5d7c0667d53 17630-2026 HUMAN OTC DRUG
Banana Boat Protective Dry SPF 6 Octocrylene and Oxybenzone and A
vobenzone OIL TOPICAL 20090522 OTC MONOGRAPH FINAL
17630-2027_2142a0e1-ed1a-449e-a352-9f950fe4e792 17630-2027 HUMAN OTC DRUG
Banana Boat Sport Performance SPF 30 Avobenzone and Octocrylene and O
xybenzone SPRAY TOPICAL 20090909 OTC MONOGRAPH FINAL
17630-2028_f7696695-e133-4cfe-bc72-4d800139a99f 17630-2028 HUMAN OTC DRUG
Banana Boat Quik Dri Sport Body and Scalp SPF 30 Avobenzone and O
ctocrylene and Oxybenzone LOTION TOPICAL 20090909 OTC MONO
GRAPH FINAL part352 "Accra-Pac, Inc." AVOBENZONE; OCTOCRYLENE; OXYBENZ
ONE .01; .077; .03 mL/mL; mL/mL; mL/mL
17630-2029_a077d77a-717c-475e-b812-2ee0fa43be25 17630-2029 HUMAN OTC DRUG
Banana Boat Ultra Defense Sheer Protect SPF 30 Avobenzone and Octocryle
ne and Oxybenzone SPRAY TOPICAL 20090909 OTC MONOGRAPH FI
NAL part352 "Accra-Pac, Inc." AVOBENZONE; OCTOCRYLENE; OXYBENZONE
.01; .077; .03 mL/mL; mL/mL; mL/mL
17630-2030_07b667aa-e5ed-4964-ba8c-ee3ab41f05a5 17630-2030 HUMAN OTC DRUG
Banana Boat Sport SPF 60 Octocrylene and Oxybenzone and Avobenzon
e SPRAY TOPICAL 20090915 OTC MONOGRAPH FINAL part352
"Accra-Pac, Inc." AVOBENZONE; OCTOCRYLENE; OXYBENZONE .03; .1; .05
mL/mL; mg/mL; mL/mL
17630-2031_dd4a145a-af97-41bf-934e-0a536d79045e 17630-2031 HUMAN OTC DRUG
Banana Boat Ultra Defense SPF 60 Canada Octocrylene and Oxybenzone and A
vobenzone SPRAY TOPICAL 20090915 OTC MONOGRAPH FINAL
part352 "Accra-Pac, Inc." AVOBENZONE; OCTOCRYLENE; OXYBENZONE .03; .1;
.05 mL/mL; mL/mL; mL/mL
17630-2032_329a8aca-13b0-4990-89bd-48e69e60ffba 17630-2032 HUMAN OTC DRUG
Banana Boat Sport SPF 50 Avobenzone and Octocrylene and Oxybenzon
mL/mL; mL/mL; mL/mL
17630-2033_7edaa698-1afd-4f83-af48-2895d699c038 17630-2033 HUMAN OTC DRUG
Banana Boat Ultra Defense Sheer Protect SPF 50 Avobenzone and Octocryle
.03; .1; .05 mL/mL; mL/mL; mL/mL
17630-2034_ac21efca-d5d1-4948-946f-91467f008ded 17630-2034 HUMAN OTC DRUG
Banana Boat Kids Protect and Play SPF 50 Avobenzone and Octocryle
.03; .1; .05 mL/mL; mL/mL; mL/mL
17630-2035_a4e3211d-f25b-4e3e-b39d-028de892f165 17630-2035 HUMAN OTC DRUG
Hawaiian Tropic Island Sport SPF 30 Avobenzone and Octocrylene and O
xybenzone SPRAY TOPICAL 20091003 OTC MONOGRAPH FINAL
17630-2036_6f5f36d2-72b7-435d-9395-e0b961e19f24 17630-2036 HUMAN OTC DRUG
Hawaiian Tropic Kids SPF 30 Avobenzone and Octocrylene and Oxybenzon
mL/mL; mL/mL; mL/mL
17630-2037_8d5b7e87-1323-4ea5-9a9b-434ba6c8f2f2 17630-2037 HUMAN OTC DRUG
Hawaiian Tropic Sheer Touch SPF 30 Octocrylene and Oxybenzone and A
vobenzone SPRAY TOPICAL 20091003 OTC MONOGRAPH FINAL
17630-2038_e0df89ba-63cb-424c-9ead-a1188320a0ce 17630-2038 HUMAN OTC DRUG
Hawaiian Tropic Island Sport SPF 30 for Canada Octocrylene and Oxybenzo
ne and Avobenzone SPRAY TOPICAL 20091003 OTC MONOGRAPH FI
.01; .077; .03 mL/mL; mL/mL; mL/mL
17630-2039_eaf7f800-8986-43b1-9a61-ba9e2ed366ed 17630-2039 HUMAN OTC DRUG
Hawaiian Tropic Carrot Protective Oil SPF 30 Octocrylene and Oxybenzo
ne and Avobenzone OIL TOPICAL 20091215 OTC MONOGRAPH FI
.02; .077; .03 mL/mL; mL/mL; mL/mL
17630-2040_d7b8f27e-e6c1-49e3-aaf5-89b61baa8a2e 17630-2040 HUMAN OTC DRUG
Banana Boat Sport Performance SPF 30 Canada Homosalate and Octinoxat
e and Octisalate and Oxybenzone and Avobenzone and Octocrylene SPRAY TOPICAL
17630-2041_b862a610-f3db-4809-9a68-64e7cb0d2748 17630-2041 HUMAN OTC DRUG
Banana Boat Ultra Defense SPF 30 Canada Homosalate and Octinoxate and Oc
tisalate and Oxybenzone and Avobenzone and Octocrylene SPRAY TOPICAL 20100102
17630-2042_e7ede41e-8d88-4c4f-a3d4-bf313ba4f3d6 17630-2042 HUMAN OTC DRUG
Banana Boat Sport Performance SPF 15 Canada Homosalate and Octinoxat
e and Octisalate and Avobenzone and Octocrylene and Oxybenzone SPRAY TOPICAL
; .05; .05; .025; .02 mL/mL; mL/mL; mL/mL; mL/mL; mL/mL; mL/mL
17630-2043_b4aebf76-9b82-4a6b-9189-fcafdecbd758 17630-2043 HUMAN OTC DRUG
Banana Boat Ultra defense SPF 50 Canada Homosalate and Octinoxate and Oc
tisalate and Oxybenzone and Avobenzone and Octocrylene SPRAY TOPICAL 20090914
17630-2044_48c3ba2a-bd4b-4426-98b4-5622274eab56 17630-2044 HUMAN OTC DRUG
Banana Boat Ultra Defense Sheer Protect FPS 50 LATAM Homosalate and O
ctinoxate and Octisalate and Octocrylene and Oxybenzone and Avobenzone SPRAY
TOPICAL 20100315 OTC MONOGRAPH FINAL part352 "Accra-Pac, Inc.
" AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
.03; .0878; .075; .05; .025; .05 mL/mL; mL/mL; mL/mL; mL/mL; mL/mL; mL/mL
17630-2045_289b4459-15ba-45f6-b571-51559b4b2d2e 17630-2045 HUMAN OTC DRUG
Banana Boat Ultra Mist Kids FPS 60 LATAM Homosalate and Octinoxat
e and Octisalate and Octocrylene and Oxybenzone and Avobenzone SPRAY TOPICAL
AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE .03; .1; .075; .
05; .05 mL/mL; mL/mL; mL/mL; mL/mL; mL/mL
45014-130_c96c5d9b-5566-4135-9438-0032c4e9b5a0 45014-130 HUMAN OTC DRUG
Acetaminophen Acetaminophen LIQUID ORAL 20111001
OTC MONOGRAPH FINAL part343 "Accudial Pharmaceutical, Inc." ACETAMINOPHEN
160 mg/5mL
45014-131_c9eb1f5c-6b5a-4ba5-932f-412a2fa463a1 45014-131 HUMAN OTC DRUG
Pain and Fever Acetaminophen SUSPENSION ORAL 20100104
OTC MONOGRAPH FINAL part343 "Accudial Pharmaceutical, Inc." ACETAMINOPHEN
160 mg/5mL
45014-136_33988a22-7905-4454-a0ee-6e402fd9ba5e 45014-136 HUMAN OTC DRUG
Childrens Accudial Pain reliever/ Fever reducer Acetaminophen SUSPENSI
ON ORAL 20120425 OTC MONOGRAPH FINAL part343 "Accudia
l Pharmaceutical, Inc." ACETAMINOPHEN 160 mg/5mL
45014-137_3614e44e-8510-4fd2-9762-741b9659323d 45014-137 HUMAN OTC DRUG
Childrens ACCUDIAL Pain reliever/ Fever reducer Acetaminophen SUSPENSI
45014-138_12ffc15e-707e-4f2d-8be8-731ded3db3aa 45014-138 HUMAN OTC DRUG
45014-139_e3231b59-92e6-4c68-9e50-e469fc2c2958 45014-139 HUMAN OTC DRUG
45014-140_ad761594-3a4d-403b-9f45-6cdbf365d0ab 45014-140 HUMAN OTC DRUG
Allergy Diphenhydramine Hydrochloride LIQUID ORAL 20091026
OTC MONOGRAPH FINAL part341 "Accudial Pharmaceutical, Inc." DIPHENHYDRAMINE
HYDROCHLORIDE 12.5 mg/5mL
45014-141_bd6d673a-27d7-4fa7-9d0f-62a89882ea6e 45014-141 HUMAN OTC DRUG
Allergy and Stuffy Nose Chlorpheniramine Maleate and Phenylephrine Hydro
chloride LIQUID ORAL 20091111 OTC MONOGRAPH FINAL
part341 "Accudial Pharmaceutical, Inc." CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE
HYDROCHLORIDE 1; 2.5 mg/5mL; mg/5mL
45014-150_f0ffa4f3-7a9c-44ed-a4c1-cba9af870345 45014-150 HUMAN OTC DRUG
Chest Congestion Guaifenesin LIQUID ORAL 20091026
OTC MONOGRAPH FINAL part341 "Accudial Pharmaceutical, Inc." GUAIFENESIN
100 mg/5mL
45014-151_3c3797ea-03dd-41d3-8f2d-bcd80ee1c040 45014-151 HUMAN OTC DRUG
Cough and Cold Chlorpheniramine Maleate and Dextromethorphan Hydrobromi
de LIQUID ORAL 20091125 OTC MONOGRAPH FINAL part341
"Accudial Pharmaceutical, Inc." CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDRO
BROMIDE 1; 7.5 mg/5mL; mg/5mL
45014-152_0fc0b6aa-ff81-4bff-b9d5-e10634b3c244 45014-152 HUMAN OTC DRUG
Daytime Cough And Cold Dextromethorphan Hydrobromide and Phenylephrine
Hydrochloride LIQUID ORAL 20091026 OTC MONOGRAPH FINAL
part341 "Accudial Pharmaceutical, Inc." DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPH
RINE HYDROCHLORIDE 5; 1.25 mg/5mL; mg/5mL
45014-153_fa42da7d-006e-41a9-9885-5cb317e86020 45014-153 HUMAN OTC DRUG
Runny Nose and Cough "Brompheniramine Maleate, Dextromethorphan Hydro
bromide and Phenylephrine Hydrochloride" LIQUID ORAL 20091104
OTC MONOGRAPH FINAL part341 "Accudial Pharmaceutical, Inc." BROMPHENIRAMINE
MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE .5; 5; 1
.25 mg/5mL; mg/5mL; mg/5mL
45014-154_2d46d37d-abad-4b65-a19c-69d843ea6662 45014-154 HUMAN OTC DRUG
Nite Time Cold and Cough Diphenhydramine Hydrochloride and Phenyl
ephrine Hydrochloride LIQUID ORAL 20091125 OTC MONOGRAPH FI
NAL part341 "Accudial Pharmaceutical, Inc." DIPHENHYDRAMINE HYDROCHLORIDE; P
HENYLEPHRINE HYDROCHLORIDE 6.25; 2.5 mg/5mL; mg/5mL
45014-158_97558c3c-84f5-4185-8462-a113bd2e3be8 45014-158 HUMAN OTC DRUG
Daytime Cough and Cold Dextromethorphan Hydrobromide and Phenylephrine
Hydrochloride SOLUTION ORAL 20130201 OTC MONOGRAPH FI
NAL part341 "Accudial Pharmaceutical, Inc." DEXTROMETHORPHAN HYDROBROMIDE; P
HENYLEPHRINE HYDROCHLORIDE 5; 2.5 mg/5mL; mg/5mL
45014-159_9eaf18d1-da77-46e4-9730-3671f8529fb6 45014-159 HUMAN OTC DRUG
Nite Time Cold and Cough Diphenhydramine Hydrochloride and Phenyl
ephrine Hydrochloride SOLUTION ORAL 20130201 OTC MONO
GRAPH FINAL part341 "Accudial Pharmaceutical, Inc." DIPHENHYDRAMINE HYDROCHL
ORIDE; PHENYLEPHRINE HYDROCHLORIDE 6.25; 2.5 mg/5mL; mg/5mL
45014-161_f8c91261-b067-4bea-810b-6b28dc893b0e 45014-161 HUMAN OTC DRUG
Allergy Diphenhydramine Hydrochloride LIQUID ORAL 20130201
OTC MONOGRAPH FINAL part341 "Accudial Pharmaceutical, Inc." DIPHENHYDRAMINE
HYDROCHLORIDE 12.5 mg/5mL
45014-163_c7ba2caf-ed17-4171-b900-4d3e0155cdc4 45014-163 HUMAN OTC DRUG
Chest Congestion Guaifenesin SOLUTION ORAL 20130201
OTC MONOGRAPH FINAL part341 "Accudial Pharmaceutical, Inc." GUAIFENESIN
100 mg/5mL
42192-101_6ac70026-fae6-4259-8854-8fe97a57b57a 42192-101 HUMAN PRESCRIPTI
ON DRUG UREA UREA EMULSION TOPICAL 20101108
UNAPPROVED DRUG OTHER ACELLA PHARMACEUTICALS UREA 50 g/100g
42192-115_d694ff1b-66fe-4099-9acf-b14169bd47b2 42192-115 HUMAN PRESCRIPTI
ON DRUG UREA HYDRATING TOPICAL UREA "AEROSOL, FOAM" TOPICAL 20101109
UNAPPROVED DRUG OTHER Acella Pharmaceuticals UREA 35 g/100g
42192-121_bfd99a0b-c88c-4b98-854e-8d1310b1a2d6 42192-121 HUMAN PRESCRIPTI
ON DRUG SODIUM SULFACETAMIDE - SULFUR WASH "SODIUM SULFACETAMIDE, S
ULFUR" LIQUID TOPICAL 20100916 UNAPPROVED DRUG OTHER
ACELLA PHARMACEUTICALS SULFACETAMIDE; SULFUR 90; 40 mg/473.2mL; mg/473.2mL
"Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient]"
42192-605_2884b04a-27e3-4892-9705-c7f42763db88 42192-605 HUMAN PRESCRIPTI
ON DRUG Tranexamic Acid Tranexamic Acid "INJECTION, SOLUTION" INTRAVEN
OUS 20140211 ANDA ANDA202436 Acella Pharmaceuticals
TRANEXAMIC ACID 100 mg/mL "Antifibrinolytic Agent [EPC],Decreased Fibrinol
ysis [PE]"
42192-708_8ed7e206-b72f-4c10-b01a-5fecaa2f9725 42192-708 HUMAN PRESCRIPTI
ON DRUG Antipyrine and Benzocaine Otic "ANTIPYRINE, BENZOCAINE"
SOLUTION AURICULAR (OTIC) 20101109 UNAPPROVED DRUG
OTHER Acella Pharmaceuticals ANTIPYRINE; BENZOCAINE 54; 14 mg/mL; m
g/mL "Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],C
ell-mediated Immunity [PE],Allergens [Chemical/Ingredient]"
42192-710_94853e4e-e83a-4aee-967e-4ec73c926674 42192-710 HUMAN PRESCRIPTI
ON DRUG Acella Antipyrine and Benzocaine Otic "ANTIPYRINE, BENZOCAINE"
OTHER Acella Pharmaceuticals ANTIPYRINE; BENZOCAINE 54; 14 mg/mL; m
g/mL "Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],C
ell-mediated Immunity [PE],Allergens [Chemical/Ingredient]"
42192-104_8da300bc-834c-4814-a799-b9ebc9056d8d 42192-104 HUMAN PRESCRIPTI
ON DRUG SODIUM SULFACETAMIDE and SULFUR Wash SODIUM SULFACETAMIDE and SULFUR
LIQUID TOPICAL 20080208 UNAPPROVED DRUG OTHER "Acella
Pharmaceuticals, LLC" SULFACETAMIDE SODIUM; SULFUR 100; 10 mg/g; mg/g
42192-105_13b45320-6394-47c3-b97d-8a0d2cdd34a9 42192-105 HUMAN OTC DRUG
BPO benzoyl peroxide GEL TOPICAL 20090101
OTC MONOGRAPH NOT FINAL part333D "Acella Pharmaceuticals, LLC" BENZOYL
PEROXIDE 4 mg/100mg
42192-106_b006ce8f-47a7-4df9-a282-0f0c4bbedaf5 42192-106 HUMAN OTC DRUG
BPO benzoyl peroxide GEL TOPICAL 20090101
OTC MONOGRAPH NOT FINAL part333D "Acella Pharmaceuticals, LLC" BENZOYL
PEROXIDE 8 mg/100mg
42192-107_a293e789-43b1-43f2-a8b0-0fb761b825c9 42192-107 HUMAN PRESCRIPTI
ON DRUG Hydrocortisone Acetate and Pramoxine Hydrochloride Hydrocor
tisone Acetate and Pramoxine Hydrochloride CREAM TOPICAL 20081103
UNAPPROVED DRUG OTHER "Acella Pharmaceuticals, LLC" HYDROCORTISONE A
CETATE; PRAMOXINE HYDROCHLORIDE 2.5; 1 g/100g; g/100g "Corticosteroid [EPC],Co
rticosteroid Hormone Receptor Agonists [MoA]"
42192-108_cfabcb14-e037-450a-ae1f-ab93b11c8776 42192-108 HUMAN PRESCRIPTI
ON DRUG Acella Hydrocortisone Acetate - Pramoxine Singles "HYDROCO
RTISONE ACETATE, PRAMOXINE" CREAM TOPICAL 20101108 UNAPPROV
ED DRUG OTHER "Acella Pharmaceuticals, LLC" HYDROCORTISONE ACETATE;
PRAMOXINE 2.5; 1 g/100g; g/100g "Corticosteroid [EPC],Corticosteroid Hor
mone Receptor Agonists [MoA]"
42192-109_50a0add2-6616-41e8-8a0c-af98a6c73e5a 42192-109 HUMAN PRESCRIPTI
ON DRUG Hydrocortisone Acetate and Pramoxine Hydrochloride Hydrocor
tisone Acetate and Pramoxine Hydrochloride CREAM TOPICAL 20081103
UNAPPROVED DRUG OTHER "Acella Pharmaceuticals, LLC" HYDROCORTISONE A
CETATE; PRAMOXINE HYDROCHLORIDE 10; 10 mg/g; mg/g "Corticosteroid [EPC],Co
42192-110_4fee6a52-b2fa-4456-9104-b2c031a3374c 42192-110 HUMAN OTC DRUG
BPO Creamy Wash Complete Pack BENZOYL PEROXIDE KIT
20110927 OTC MONOGRAPH FINAL part333D "Acella Pharmace
uticals, LLC"
42192-111_c50e4101-c596-4b43-be65-dac3b98516be 42192-111 HUMAN OTC DRUG
BPO Creamy Wash Complete Pack BENZOYL PEROXIDE KIT
20090819 OTC MONOGRAPH FINAL part333D "Acella Pharmace
uticals, LLC"
42192-112_9661ef5a-03cc-4d24-a764-ec2c8a9163df 42192-112 HUMAN PRESCRIPTI
ON DRUG SALICYLIC ACID SALICYLIC ACID "AEROSOL, FOAM" TOPICAL 20100716
UNAPPROVED DRUG OTHER "Acella Pharmaceuticals, LLC" SALICYLIC ACID
6 g/100g
42192-113_15c56071-3f65-4b1f-8d9b-b59dfd66cbfe 42192-113 HUMAN PRESCRIPTI
ON DRUG SODIUM SULFACETAMIDE - SULFUR CLEANSING PADS "SODIUM SULFACET
AMIDE, SULFUR" SWAB TOPICAL 20100916 UNAPPROVED DRUG OTHER
"Acella Pharmaceuticals, LLC" SULFACETAMIDE SODIUM; SULFUR 10; 4 g/100g;
g/100g "Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient]"
42192-119_c3eb0ff9-799b-49a2-8369-a91fe751821a 42192-119 HUMAN PRESCRIPTI
ON DRUG hydrocortisone acetate pramoxine hcl hydrocortisone acetate p
ramoxine hcl KIT 20100201 UNAPPROVED DRUG OTHER
"Acella Pharmaceuticals, LLC"
42192-124_fa6d2031-f4db-4d10-811b-e54e78652659 42192-124 HUMAN PRESCRIPTI
ON DRUG BPO 3 Foaming BENZOYL PEROXIDE CLOTH TOPICAL 20100818
UNAPPROVED DRUG OTHER "Acella Pharmaceuticals, LLC" BENZOYL PEROXIDE
3.2 g/100g
42192-125_504b9718-9366-4ae8-b349-fdb18b084dde 42192-125 HUMAN PRESCRIPTI
3.2 g/100g
42192-128_a28d24fe-9ec4-4e13-a141-86bb3e5f89a2 42192-128 HUMAN PRESCRIPTI
9 g/100g
42192-129_77671f48-b574-490f-a1c2-b321af8dac52 42192-129 HUMAN PRESCRIPTI
ON DRUG SODIUM SULFACETAMIDE SODIUM SULFACETAMIDE LIQUID TOPICAL
20101214 UNAPPROVED DRUG OTHER "Acella Pharmaceuticals,
LLC" SULFACETAMIDE SODIUM 100 mg/mL "Sulfonamide Antibacterial [EPC]
,Sulfonamides [Chemical/Ingredient]"
42192-130_ce96e7b2-772b-4196-9039-484e823fbd0f 42192-130 HUMAN PRESCRIPTI
ON DRUG SALICYLIC ACID SALICYLIC ACID "AEROSOL, FOAM" TOPICAL 20110427
6 g/100g
42192-133_c3ff4716-6009-4e29-9da9-ea740726cc3c 42192-133 HUMAN PRESCRIPTI
ON DRUG Sodium Sulfacetamide and Sulfur Sodium Sulfacetamide and Sulfur
SOLUTION TOPICAL 20110727 UNAPPROVED DRUG OTHER
"Acella Pharmaceuticals, LLC" SULFACETAMIDE SODIUM; SULFUR 80; 40 mg/mL; m
g/mL "Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient]"
42192-134_996ad0d5-d635-4ed4-8263-d7f773260421 42192-134 HUMAN PRESCRIPTI
ON DRUG Salicylic Acid SALICYLIC ACID GEL TOPICAL 20110519
60 mg/g
42192-135_572171f7-832f-4710-b888-eef5638fc9d4 42192-135 HUMAN PRESCRIPTI
ON DRUG SALICYLIC ACID SALICYLIC ACID LIQUID TOPICAL 20110921
275 mg/mL
42192-136_1926eadd-d11f-44fa-971f-0041060f7589 42192-136 HUMAN PRESCRIPTI
ON DRUG Sodium Sulfacetamide 10 Sulfur 5 Cleanser Sulfacetamide So
dium and Sulfur RINSE TOPICAL 20100916 UNAPPROVED DRUG OTHER
"Acella Pharmaceuticals, LLC" SULFACETAMIDE SODIUM; SULFUR 10; 5 mg/g; mg
/g "Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient]"
42192-138_eab3f887-e137-49a1-aa85-1ebe634065f7 42192-138 HUMAN PRESCRIPTI
ON DRUG Sodium Sulfacetamide 10 Sulfur 5 Sulfacetamide Sodium and
Sulfur CLOTH TOPICAL 20110208 UNAPPROVED DRUG OTHER
42192-139_99705c54-b7af-423d-8f20-881e8fea236f 42192-139 HUMAN PRESCRIPTI
ON DRUG "SODIUM SULFACETAMIDE, SULFUR" Sodium Sulfacetamide and Sulfur
CREAM TOPICAL 20110727 UNAPPROVED DRUG OTHER "Acella
42192-144_a761feea-86b6-44f0-8f9a-50d29ebb60e9 42192-144 HUMAN PRESCRIPTI
ON DRUG Sodium Sulfacetamide 9 Sulfur 4.5 Wash Sulfacetamide Sodium and
Sulfur RINSE TOPICAL 20110720 UNAPPROVED DRUG OTHER
"Acella Pharmaceuticals, LLC" SULFACETAMIDE SODIUM; SULFUR 9; 4.5 mg/g; mg
42192-146_c7b051aa-a1c4-4f0e-9278-2387155857b0 42192-146 HUMAN PRESCRIPTI
ON DRUG Sodium Sulfacetamide Sodium Sulfacetamide GEL TOPICAL
LLC" SULFACETAMIDE SODIUM 100 mg/g "Sulfonamide Antibacterial [EPC]
42192-147_210774a9-aaab-4bd4-ac5a-481ed72e0c0c 42192-147 HUMAN PRESCRIPTI
ON DRUG Sodium Sulfacetamide 10 Sulfur 2 Cleanser Sulfacetamide So
dium and Sulfur SOLUTION TOPICAL 20080208 UNAPPROVED DRUG
OTHER "Acella Pharmaceuticals, LLC" SULFACETAMIDE SODIUM; SULFUR
100; 20 mg/g; mg/g "Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/
Ingredient]"
42192-149_99705c54-b7af-423d-8f20-881e8fea236f 42192-149 HUMAN PRESCRIPTI
ON DRUG "SODIUM SULFACETAMIDE, SULFUR" Sodium Sulfacetamide and Sulfur
CREAM TOPICAL 20110727 UNAPPROVED DRUG OTHER "Acella
42192-150_a57b734d-5d6d-4cd7-8003-9174cc785e41 42192-150 HUMAN PRESCRIPTI
ON DRUG Sodium Sulfacetamide 10 Sulfur 2 cream Sulfacetamide Sodium and
Sulfur CREAM TOPICAL 20080208 UNAPPROVED DRUG OTHER
42192-151_595dfc50-ee6f-41b5-ab5b-4c293aee342b 42192-151 HUMAN PRESCRIPTI
ON DRUG HYDROQUINONE 4% Hydroquinone CREAM TOPICAL 20110117
UNAPPROVED DRUG OTHER "Acella Pharmaceuticals, LLC" HYDROQUINONE
40 mg/g "Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Me
lanin Synthesis Inhibitors [MoA]"
42192-320_9f4ce551-7a80-4ddb-a014-95c44b54a420 42192-320 HUMAN PRESCRIPTI
ON DRUG PNV-Select "VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFER
OL, .ALPHA.-TOCOPHEROL ACETATE, DL, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMID
E, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, CALCIUM PANTOTH
ENATE, CALCIUM CARBONATE, FERROUS FUMARATE, POTASSIUM IODIDE, MAGNESIUM OXIDE, Z
INC OXIDE and CUPRIC OXIDE," "TABLET, FILM COATED" ORAL 20091102
UNAPPROVED DRUG OTHER "Acella Pharmaceuticals, LLC" ".ALPHA.-TOCOPHE
ROL ACETATE, DL-; ASCORBIC ACID; BIOTIN; CALCIUM CARBONATE; CALCIUM PANTOTHENATE
; CHOLECALCIFEROL; CUPRIC OXIDE; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; M
AGNESIUM OXIDE; NIACINAMIDE; POTASSIUM IODIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLA
VIN; THIAMINE MONONITRATE; VITAMIN A ACETATE; ZINC OXIDE" 10; 80; 300; 120
; 6; 400; 2; 12; 27; 1; 30; 20; 150; 20; 3.4; 3; 2500; 15 [iU]/1; mg/1; ug
/1; mg/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg
/1; [iU]/1; ug/1 "Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin
D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vita
min B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activi
ty [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Ca
lculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA]"
42192-321_038fe2e7-dc16-485c-b5fb-746db7231347 42192-321 HUMAN PRESCRIPTI
ON DRUG PNV-DHA "ascorbic acid, cholecalciferol, .alpha.-tocopherol acet
ate, dl-, pyridoxine, folic acid, cyanocobalamin, calcium, ferrous fumarate, mag
nesium, doconexent" "CAPSULE, GELATIN COATED" ORAL 20091102
ROL ACETATE, DL-; ASCORBIC ACID; CALCIUM; CHOLECALCIFEROL; CYANOCOBALAMIN; DOCON
EXENT; FERROUS FUMARATE; FOLIC ACID; MAGNESIUM; PYRIDOXINE" 10; 85; 140; 200
; 12; 300; 27; 1; 45; 25 [iU]/1; [iU]/1; mg/1; [iU]/1; ug/1; mg/1; mg/1;
mg/1; mg/1; [iU]/1 "Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin
B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Calcium [Chemical/Ingredient],Calc
ium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA]"
42192-329_3dff2a17-c907-4e46-b6bd-f6ff40292af4 42192-329 HUMAN PRESCRIPTI
ON DRUG NP Thyroid 30 "LEVOTHYROXINE, LIOTHYRONINE" TABLET TOPICAL
LLC" LEVOTHYROXINE; LIOTHYRONINE 19; 4.5 ug/1; ug/1 "l-Thyroxine [EP
C],Thyroxine [Chemical/Ingredient],l-Triiodothyronine [EPC],Triiodothyronine [Ch
emical/Ingredient]"
42192-330_ebfa540a-1ce7-4f33-8343-65121e23c401 42192-330 HUMAN PRESCRIPTI
LLC" LEVOTHYROXINE; LIOTHYRONINE 38; 9 ug/1; ug/1 "l-Thyroxine [EP
C],Thyroxine [Chemical/Ingredient],l-Triiodothyronine [EPC],Triiodothyronine [Ch
emical/Ingredient]"
42192-331_771d13d3-b76b-4cbc-a096-991e06796c90 42192-331 HUMAN PRESCRIPTI
LLC" LEVOTHYROXINE; LIOTHYRONINE 57; 13.5 ug/1; ug/1 "l-Thyro
xine [EPC],Thyroxine [Chemical/Ingredient],l-Triiodothyronine [EPC],Triiodothyro
nine [Chemical/Ingredient]"
42192-336_491ffe0a-a8a0-43da-b2f8-5b1a59c70a45 42192-336 HUMAN PRESCRIPTI
ON DRUG Chlordiazepoxide Hydrochloride And Clidinium Bromide "CHLORDI
AZEPOXIDE HYDROCHLORIDE, CLIDINIUM BROMIDE" CAPSULE ORAL 20110830
UNAPPROVED DRUG OTHER "Acella Pharmaceuticals, LLC" CHLORDIAZEPOXIDE
HYDROCHLORIDE; CLIDINIUM BROMIDE 5; 2.5 mg/1; mg/1 "Benzodiazepine
[EPC],Benzodiazepines [Chemical/Ingredient],Anticholinergic [EPC],Decreased Para
sympathetic Acetylcholine Activity [PE],GI Motility Alteration [PE],Digestive/GI
System Activity Alteration [PE],Cholinergic Antagonists [MoA]" CIV
42192-341_7240d5fb-cb2d-4278-988f-c8e6bba6560d 42192-341 HUMAN PRESCRIPTI
ON DRUG Prenaissance "CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCI
FEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DO
CUSATE SODIUM and DOCONEXENT" "CAPSULE, LIQUID FILLED" ORAL 20110519
ROL, D-; ASCORBIC ACID; CHOLECALCIFEROL; DOCONEXENT; DOCUSATE SODIUM; FERROUS FU
MARATE; FOLIC ACID; PYRIDOXINE HYDROCHLORIDE; TRICALCIUM PHOSPHATE" 30; 28;
800; 325; 55; 29; 1.25; 25; 160 [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg
/1; mg/1 "Blood Coagulation Factor [EPC],Increased Coagulation Factor Act
ivity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient]
,Vitamin D [Chemical/Ingredient],Vitamin D [EPC]"
42192-343_1459ccd1-2372-450f-ac17-382ca9a5b175 42192-343 HUMAN PRESCRIPTI
ON DRUG Prenaissance Plus "CALCIUM CITRATE, IRON PENTACARBONYL, CH
OLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC
ACID, DOCUSATE SODIUM and DOCONEXENT" "CAPSULE, LIQUID FILLED" ORAL
LLC" ".ALPHA.-TOCOPHEROL ACETATE, DL-; CALCIUM CITRATE; CHOLECALCIFEROL; DOCO
NEXENT; DOCUSATE SODIUM; FOLIC ACID; IRON PENTACARBONYL; PYRIDOXINE HYDROCHLORID
E" 30; 100; 400; 250; 50; 1; 28; 25 [iU]/1; mg/1; [iU]/1; mg/1; mg/1
; mg/1; mg/1; mg/1 "Blood Coagulation Factor [EPC],Increased Coagulation Fa
ctor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ing
redient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC]"
42192-350_30b14bbd-37cf-44c5-89c6-cdf8c7ded7c5 42192-350 HUMAN PRESCRIPTI
ON DRUG PNV-First ".beta.-carotene, cholecalciferol, ascorbic acid
, .alpha.-tocopherol acetate, dl-, folic acid, thiamine mononitrate, riboflavin,
pyridoxine hydrochloride, cyanocobalamin, niacinamide, calcium carbonate, ferro
us fumarate, magnesium oxide, zinc oxide, cupric oxide and doconexent" "TABLET,
COATED" ORAL 20130517 UNAPPROVED DRUG OTHER
"Acella Pharmaceuticals, LLC" ".ALPHA.-TOCOPHEROL ACETATE, DL-; .BETA.-CAROTEN
E; ASCORBIC ACID; CHOLECALCIFEROL; CUPRIC OXIDE; CYANOCOBALAMIN; FOLIC ACID; IRO
N SUCROSE; MAGNESIUM OXIDE; NIACINAMIDE; OMEGA-3 FATTY ACIDS; POTASSIUM IODIDE;
PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; ZINC OXIDE" 20; 1100
; 30; 1000; 2; 12; 1; 29; 20; 15; 200; 150; 2.5; 1.8; 1.6; 25 [iU]/1; [iU]/1;
mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1;
mg/1 "Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Iron [Chemical/Ing
redient],Parenteral Iron Replacement [EPC],Calculi Dissolution Agent [EPC],Magne
sium Ion Exchange Activity [MoA],Fatty Acids, Omega-3 [Chemical/Ingredient],Omeg
a-3 Fatty Acid [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC]"
42192-352_0278a8ed-b74a-44ce-8d8b-e9cdf19b953b 42192-352 HUMAN PRESCRIPTI
ON DRUG PNV-OB-DHA ".beta.-carotene, cholecalciferol, ascorbic acid
us fumarate, magnesium oxide, zinc oxide, cupric oxide and doconexent" KIT
20130517 20150531 UNAPPROVED DRUG OTHER "Acella Pharmace
uticals, LLC"
42192-353_23baa821-7703-4523-99ca-ffd57a0beb14 42192-353 HUMAN PRESCRIPTI
ON DRUG Choice OB DHA ".beta.-carotene, cholecalciferol, ascorbic acid
us fumarate, magnesium oxide, zinc oxide, cupric oxide and doconexent" KIT
20130517 20150731 UNAPPROVED DRUG OTHER "Acella Pharmace
uticals, LLC"
42192-365_abb9570f-3866-4f6c-befc-2ca9f1f0902b 42192-365 HUMAN PRESCRIPTI
ON DRUG Salsalate Salsalate TABLET ORAL 20110516
UNAPPROVED DRUG OTHER "Acella Pharmaceuticals, LLC" SALSALATE
500 mg/1
42192-366_abb9570f-3866-4f6c-befc-2ca9f1f0902b 42192-366 HUMAN PRESCRIPTI
UNAPPROVED DRUG OTHER "Acella Pharmaceuticals, LLC" SALSALATE
750 mg/1
42192-520_6eaf0913-2d56-45d7-a430-47d9c1792e84 42192-520 HUMAN PRESCRIPTI
ON DRUG QUADRAPAX "Phenobarbital, Hyoscyamine Sulfate, Atropine Su
lfate, Scopolamine Hydrobromide" ELIXIR ORAL 20110506
UNAPPROVED DRUG OTHER "Acella Pharmaceuticals, LLC" ATROPINE SULFATE
; HYOSCYAMINE SULFATE; PHENOBARBITAL; SCOPOLAMINE HYDROBROMIDE .0194; .1037; 16
.2; .0065 mg/5mL; mg/5mL; mg/5mL; mg/5mL "Anticholinergic [EPC],Cholinerg
ic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscari
nic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA]"
CIV
42192-521_1089fc64-2296-4c80-a0db-efd50e693a25 42192-521 HUMAN OTC DRUG
Pyrilamine-Phenylephrine Pyrilamine Maleate and Phenylephrine Hyd
rochloride LIQUID ORAL 20120822 OTC MONOGRAPH FINAL
part341 "Acella Pharmaceuticals, LLC" PHENYLEPHRINE HYDROCHLORIDE; PYRILAMINE
MALEATE 5; 16 mg/5mL; mg/5mL
42192-523_1d253b18-9354-4c22-8859-888e1940935c 42192-523 HUMAN OTC DRUG
Entre-Cough "Dextromethorphan Hydrobromide, Pseudoephedrine Hydrochl
oride, Guaifensin" LIQUID ORAL 20130204 OTC MONOGRAPH FI
NAL part341 "Acella Pharmaceuticals, LLC" DEXTROMETHORPHAN HYDROBROMIDE; G
UAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 15; 175; 30 mg/5mL; mg/5mL;
mg/5mL
42192-608_3255245c-6ae6-46ab-a1c1-0b8d4d4cdaa2 42192-608 HUMAN PRESCRIPTI
ON DRUG Gabapentin gabapentin SOLUTION ORAL 20121001
ANDA ANDA076403 "Acella Pharmaceuticals, LLC" GABAPENTIN 250
mg/5mL "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganize
d Electrical Activity [PE]"
42192-705_814d7c39-a917-43c3-bb6b-efce322607e0 42192-705 HUMAN PRESCRIPTI
ON DRUG Ciclopirox Ciclopirox KIT 20090701
UNAPPROVED DRUG OTHER "Acella Pharmaceuticals, LLC"
42192-707_8a0d307f-6f64-4db0-aad3-a59881dcdbd9 42192-707 HUMAN PRESCRIPTI
ON DRUG Urea Urea SOLUTION TOPICAL 20090622
UNAPPROVED DRUG OTHER "Acella Pharmaceuticals, LLC" UREA 400
mg/g
42192-712_7ce00087-4c0d-48c5-bf22-a99e207130e7 42192-712 HUMAN PRESCRIPTI
ON DRUG Aurax Otic "ANTIPYRINE, BENZOCAINE" SOLUTION
AURICULAR (OTIC) 20110912 UNAPPROVED DRUG OTHER
"Acella Pharmaceuticals, LLC" ANTIPYRINE; BENZOCAINE 55; 14 mg/mL; mg/mL
"Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-medi
ated Immunity [PE],Allergens [Chemical/Ingredient]"
42192-714_2c67dd09-ab1f-4ccf-97b5-421356f64f22 42192-714 HUMAN PRESCRIPTI
ON DRUG Ciclopirox Ciclopirox KIT 20110912
UNAPPROVED DRUG OTHER "Acella Pharmaceuticals, LLC"
10006-001_b8f5cc28-1546-47a9-9bc0-d60fa9745df9 10006-001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS Acetylene Oxygen Company OXYGEN 99
L/100L
10006-002_c4065ed6-237f-4545-bad2-a51e95a70949 10006-002 HUMAN PRESCRIPTI
ON DRUG NITROUS OXIDE NITROUS OXIDE GAS RESPIRATORY (INHALATION)
19360101 UNAPPROVED MEDICAL GAS Acetylene Oxygen Company
NITROUS OXIDE 99 L/100L
10006-003_90f9a709-879d-4308-9287-862c93c0f12b 10006-003 HUMAN PRESCRIPTI
ON DRUG CARBON DIOXIDE CARBON DIOXIDE GAS RESPIRATORY (INHALATION)
CARBON DIOXIDE 99 kg/100kg "Radiographic Contrast Agent [EPC],X-Ray
Contrast Activity [MoA]"
10006-004_a8b5c8ac-a3f7-4184-8ccf-020926d48fe0 10006-004 HUMAN PRESCRIPTI
ON DRUG MEDICAL AIR AIR GAS RESPIRATORY (INHALATION)
OXYGEN 21 L/100L
10006-005_8bed956b-282d-414d-95fb-d33d0693800a 10006-005 HUMAN PRESCRIPTI
ON DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION)
NITROGEN 99 L/100L
10006-008_73d34d59-69b0-4bc0-b31d-617aa0d5b3fc 10006-008 HUMAN PRESCRIPTI
ON DRUG HELIUM HELIUM GAS RESPIRATORY (INHALATION) 19360101
UNAPPROVED MEDICAL GAS Acetylene Oxygen Company HELIUM 99
L/100L
10006-009_1366bd51-4f64-48d6-baa1-1fb402553331 10006-009 HUMAN PRESCRIPTI
ON DRUG HELIOX HELIOX GAS RESPIRATORY (INHALATION) 19360101
L/100L
L/100L
L/100L
68784-102_80ab9dbd-08db-4aa1-afff-6daf6987b2b7 68784-102 HUMAN OTC DRUG
BISACODYL BISACODYL SUPPOSITORY RECTAL 20050101
OTC MONOGRAPH NOT FINAL part334 "Acino Products, LLC" BISACODYL 10
mg/1
68784-101_9fbf7acd-f075-4a82-a47d-d0484055bfc5 68784-101 HUMAN OTC DRUG
Hemorrhoidal "COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE" SUPPOSIT
ORY RECTAL 20140401 OTC MONOGRAPH FINAL part346 "Acino P
roducts, LLC." COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 1768.8; 5
mg/1; mg/1
68784-108_7b79a8c2-83a2-46ff-99bc-01b1c61bfd74 68784-108 HUMAN PRESCRIPTI
ON DRUG Rectacort - HC HYDROCORTISONE ACETATE SUPPOSITORY RECTAL
20061101 UNAPPROVED DRUG OTHER "Acino Products, LLC."
HYDROCORTISONE ACETATE 25 mg/1 "Corticosteroid [EPC],Corticosteroid Hor
0924-1805_3b31e3d8-a8aa-4329-8a06-3292db39dfca 0924-1805 HUMAN OTC DRUG
ACME Small Cuts and Burns "BENZALKONIUM CHLORIDE, LIDOCAINE, BACIT
RACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE" KIT 20100430
OTC MONOGRAPH FINAL part333 Acme United Corp.
0924-1806_9f71f835-9965-4409-9cbe-44b04a0b0022 0924-1806 HUMAN OTC DRUG
ACME FIRST AID Contains 404 PIECES "BENZALKONIUM CHLORIDE, LIDOCAIN
E, WATER, ISOPROPYL ALCOHOL, ASPIRIN, BENZOCAINE, ALCOHOL, BACITRACIN ZINC, NEOM
YCIN SULFATE, POLYMYXIN B SULFATE" KIT 20100427
0924-1807_bbe4198a-e8fb-4d98-b197-0dbeee82e056 0924-1807 HUMAN OTC DRUG
BLUE ACME SLEEVE FIRST AID Contains 1000 PIECES "BENZALKONIUM CHLORIDE,
LIDOCAINE, BENZALKONIUM CHLORIDE, WATER, ISOPROPYL ALCOHOL, ASPIRIN, BACITRACIN
ZINC,NEOMYCIN SULFATE,POLYMYXIN B SULFATE" KIT 20100427
0924-0011_915b4e91-de53-4701-ab54-ebd3ec5a216e 0924-0011 HUMAN OTC DRUG
Alcohol Prep Isopropyl Alcohol SWAB TOPICAL 20140708
OTC MONOGRAPH NOT FINAL part333A Acme United Corporation ISOPROPYL ALCOHO
L 0.7 mL/mL
0924-0014_6c9c094f-19b3-4930-ae56-b31b7681c701 0924-0014 HUMAN OTC DRUG
Pac-Kit Motion Sickness Dimenhydrinate "TABLET, COATED" ORAL
20131021 OTC MONOGRAPH FINAL part336 Acme United Corporation
DIMENHYDRINATE 50 mg/1
0924-0074_85afb49b-1b2b-4917-97c5-21f2597d817b 0924-0074 HUMAN OTC DRUG
PhysiciansCare Ibuprofen Ibuprofen TABLET ORAL 20111007
ANDA ANDA075139 Acme United Corporation IBUPROFEN 200 mg/1
0924-0086_5554956b-998c-4215-b3e2-6272d2c776bf 0924-0086 HUMAN OTC DRUG
PhysiciansCare Antacid CALCIUM CARBONATE "TABLET, CHEWABLE"
ORAL 20111128 OTC MONOGRAPH FINAL part331 Acme United Corp
oration CALCIUM CARBONATE 420 mg/1
0924-0087_3f5a4acd-cfaf-46ee-bd1d-5d9ba45a560d 0924-0087 HUMAN OTC DRUG
PhysiciansCare Antacid CALCIUM CARBONATE "TABLET, CHEWABLE"
ORAL 20120118 OTC MONOGRAPH FINAL part331 Acme United Corp
oration CALCIUM CARBONATE 420 mg/1
0924-0091_4554f4f5-d91c-47ea-8d3d-1e76befd7e8a 0924-0091 HUMAN OTC DRUG
PhysiciansCare Allergy Multi-Symptom Relief "Acetaminophen, Chlorpheniramine
Maleate, Phenylephrine Hydrochloride" "TABLET, FILM COATED" ORAL 20111223
OTC MONOGRAPH FINAL part341 Acme United Corporation ACETAMINOPHEN; CHLORPHEN
IRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1
0924-0123_356b0db2-2c37-48dd-a5ba-a5e3f90c395d 0924-0123 HUMAN OTC DRUG
PhysiciansCare Non Aspirin Extra Strength Acetaminophen "TABLET, FILM CO
ATED" ORAL 20120120 OTC MONOGRAPH NOT FINAL part343 Acme Uni
ted Corporation ACETAMINOPHEN 500 mg/1
0924-0128_d74c2e9e-1a85-4b4c-9462-c5b6470fb054 0924-0128 HUMAN OTC DRUG
PhysiciansCare Non Aspirin Extra Strength Acetaminophen "TABLET, FILM CO
ATED" ORAL 20120120 OTC MONOGRAPH NOT FINAL part343 Acme Uni
ted Corporation ACETAMINOPHEN 500 mg/1
0924-0133_14f52682-299a-4dac-8436-d3917089c926 0924-0133 HUMAN OTC DRUG
PhysiciansCare Sinus Non-Drowsy Phenylephrine HCL "TABLET, FILM CO
ATED" ORAL 20120129 OTC MONOGRAPH FINAL part341 Acme Uni
ted Corporation PHENYLEPHRINE HYDROCHLORIDE 10 mg/1
0924-0137_6ae23fa9-4b33-45b6-a95b-6887a065870f 0924-0137 HUMAN OTC DRUG
PhysiciansCare Cold and Cough Non-Drowsy "Acetaminophen, Dextromethorphan
Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride" "TABLET, FILM CO
ted Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENY
LEPHRINE HYDROCHLORIDE 325; 15; 200; 5 mg/1; mg/1; mg/1; mg/1
0924-0140_1f70d8f3-7c80-4262-81af-0fe6ee2b3384 0924-0140 HUMAN OTC DRUG
PhysiciansCare Cold and Cough Non-Drowsy "Acetaminophen, Dextromethorphan
ted Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENY
0924-0160_c55a1e12-9562-4af6-9fbc-152e2a0e8e03 0924-0160 HUMAN OTC DRUG
PhysiciansCare Ophthalmic Solution Eyewash Purified Water 98.3%
SOLUTION OPHTHALMIC 20130624 NDA NDA022305
Acme United Corporation WATER 929 g/946mL
0924-0162_41a6cb62-68f6-4cad-92f4-236fa573dfcf 0924-0162 HUMAN OTC DRUG
0924-0164_20648d16-647f-4597-8d08-9f5b1cbf9641 0924-0164 HUMAN OTC DRUG
0924-0166_41db9460-d295-4d6c-b8c7-80e5f12c656e 0924-0166 HUMAN OTC DRUG
0924-1006_3568bc0f-c8c4-4bee-a5ef-27fc4bfa4784 0924-1006 HUMAN OTC DRUG
PhysiciansCare Dimenhydrinate Motion Sickness Relief Dimenhydrinate "TABLET,
Acme United Corporation DIMENHYDRINATE 50 mg/1
0924-5000_2305a8eb-39c9-4320-9b43-9c05ccb3fb65 0924-5000 HUMAN OTC DRUG
Lidocaine Hydrochloride Lidocaine Hydrochloride GEL TOPICAL 20130214
OTC MONOGRAPH NOT FINAL part348 Acme United Corporation LIDOCAINE HYDROCHLORIDE
20 mg/g
0924-5200_e8381540-e7a1-4db2-947e-601ced32c4a3 0924-5200 HUMAN OTC DRUG
Antiseptic "alcohol, lidocaine hydrochloride" LIQUID TOPICAL
20120306 OTC MONOGRAPH NOT FINAL part333E Acme United Corp
oration ALCOHOL; LIDOCAINE HYDROCHLORIDE 500; 20 mg/g; mg/g
0924-5603_29d034b8-1c10-4319-894e-67abf6507cb8 0924-5603 HUMAN OTC DRUG
triple antibiotic "bacitracin zinc, neomycin sulfate, polymyxin b
sulfate" OINTMENT TOPICAL 20120127 OTC MONOGRAPH FI
NAL part333B Acme United Corporation BACITRACIN ZINC; NEOMYCIN SULFAT
E; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g
0924-5603_589803b1-7e58-4e60-9ac5-b17fe07d0474 0924-5603 HUMAN OTC DRUG
0924-5603_b8f41aa9-9580-45e9-b9cb-de1240f5471d 0924-5603 HUMAN OTC DRUG
0924-5701_3a6943c0-276c-4e76-a2a8-948163263d18 0924-5701 HUMAN OTC DRUG
First Aid and Burn "Benzalkonium Chloride, Lidocaine Hydrochloride"
CREAM TOPICAL 20120127 OTC MONOGRAPH NOT FINAL part333A
Acme United Corporation BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE 1.3; 5
mg/g; mg/g
0924-5701_847a8aff-6b66-427d-8bd6-e268dcc4feaf 0924-5701 HUMAN OTC DRUG
mg/g; mg/g
0924-5701_f71543e8-a6fb-4d21-9e89-f77005322002 0924-5701 HUMAN OTC DRUG
mg/g; mg/g
0924-7110_c6468ea2-775a-442d-8c88-ed3dd9843471 0924-7110 HUMAN OTC DRUG
Antiseptic benzalkonium chloride LIQUID TOPICAL 20120320
OTC MONOGRAPH NOT FINAL part333E Acme United Corporation BENZALKONIUM CHL
ORIDE 1.2478 g/L
10144-427_ef04ce09-921e-4c24-afa5-3f1f483204fb 10144-427 HUMAN PRESCRIPTI
ON DRUG AMPYRA Dalfampridine "TABLET, FILM COATED, EXTENDED RELEASE"
ORAL 20100301 NDA NDA022250 "Acorda Therapeutics, In
c." DALFAMPRIDINE 10 mg/1
10144-594_e6d660dc-aeec-4242-a393-4a352449545c 10144-594 HUMAN PRESCRIPTI
ON DRUG Zanaflex tizanidine hydrochloride TABLET ORAL
19970101 NDA NDA020397 "Acorda Therapeutics, Inc."
TIZANIDINE HYDROCHLORIDE 4 mg/1 "Adrenergic alpha2-Agonists [MoA
],Central alpha-2 Adrenergic Agonist [EPC]"
ON DRUG Zanaflex tizanidine hydrochloride CAPSULE ORAL
10144-928_004a7b0e-8564-4f7b-b7bb-13ff5ef72af8 10144-928 HUMAN PRESCRIPTI
ON DRUG Qutenza capsaicin KIT 20130812
NDA NDA022395 "Acorda Therapeutics, Inc."
10144-929_004a7b0e-8564-4f7b-b7bb-13ff5ef72af8 10144-929 HUMAN PRESCRIPTI
ON DRUG Qutenza capsaicin KIT 20130812
NDA NDA022395 "Acorda Therapeutics, Inc."
10109-1234_c9c395e1-b240-4d6c-987c-ba42915a6e30 10109-1234 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS ACS Medical LLC OXYGEN 99 L/100L
0228-3640_c38b260a-3a73-48dd-985c-7963701e969c 0228-3640 HUMAN PRESCRIPTI
ON DRUG Ropinirole Ropinirole "TABLET, FILM COATED, EXTENDED R
ELEASE" ORAL 20120518 ANDA ANDA090869 Actavis Elizabeh
LLC ROPINIROLE HYDROCHLORIDE 6 mg/1 "Dopamine Agonists [MoA]
,Nonergot Dopamine Agonist [EPC]"
0228-1112_13f01e59-e7fb-41f3-b737-716fae6ccc34 0228-1112 HUMAN PRESCRIPTI
ON DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride "CAPSULE, EXTEND
ED RELEASE" ORAL 20121001 ANDA ANDA091022 Actavis
Elizabeth LLC DILTIAZEM HYDROCHLORIDE 120 mg/1 "Calcium Channel Antagon
ists [MoA],Calcium Channel Blocker [EPC]"
0228-2027_5d876462-2509-4024-ab4d-14e6c3c33d7e 0228-2027 HUMAN PRESCRIPTI
ON DRUG Alprazolam Alprazolam TABLET ORAL 19950103
ANDA ANDA074342 Actavis Elizabeth LLC ALPRAZOLAM 0.25 mg/1
ANDA ANDA074342 Actavis Elizabeth LLC ALPRAZOLAM 0.5 mg/1
ANDA ANDA074342 Actavis Elizabeth LLC ALPRAZOLAM 1 mg/1
ANDA ANDA074342 Actavis Elizabeth LLC ALPRAZOLAM 2 mg/1
0228-2057_cdd3dc93-9266-4bd0-8d83-7478627e4a39 0228-2057 HUMAN PRESCRIPTI
ON DRUG Lorazepam Lorazepam TABLET ORAL 20070103
ANDA ANDA071403 Actavis Elizabeth LLC LORAZEPAM 0.5 mg/1
ANDA ANDA071404 Actavis Elizabeth LLC LORAZEPAM 1 mg/1
ANDA ANDA071141 Actavis Elizabeth LLC LORAZEPAM 2 mg/1
0228-2067_2e8d64b3-1712-4867-bbe6-c1e5f0f2e88a 0228-2067 HUMAN PRESCRIPTI
ON DRUG Oxazepam Oxazepam "CAPSULE, GELATIN COATED"
ORAL 20070102 ANDA ANDA072251 Actavis Elizabeth LLC
OXAZEPAM 10 mg/1 "Benzodiazepine [EPC],Benzodiazepines [Chemical/
Ingredient]" CIV
Ingredient]" CIV
Ingredient]" CIV
0228-2076_182db3b4-b3cd-4905-ad4d-65b8b6326968 0228-2076 HUMAN PRESCRIPTI
ON DRUG Temazepam Temazepam CAPSULE ORAL 19950123
ANDA ANDA071638 Actavis Elizabeth LLC TEMAZEPAM 15 mg/1
0228-2077_182db3b4-b3cd-4905-ad4d-65b8b6326968 0228-2077 HUMAN PRESCRIPTI
ANDA ANDA071620 Actavis Elizabeth LLC TEMAZEPAM 30 mg/1
0228-2127_a70aed43-d634-4e79-8e5b-3b82c16d1aa0 0228-2127 HUMAN PRESCRIPTI
ON DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL
19950103 ANDA ANDA070974 Actavis Elizabeth LLC CLONIDIN
E HYDROCHLORIDE 0.1 mg/1 "Adrenergic alpha2-Agonists [MoA],Central alpha-
2 Adrenergic Agonist [EPC]"
0228-2143_9ea4b4c2-4bb8-4094-ac9d-3faa008ba5aa 0228-2143 HUMAN PRESCRIPTI
ON DRUG Carbamazepine Carbamazepine TABLET ORAL 19950103
ANDA ANDA071696 Actavis Elizabeth LLC CARBAMAZEPINE 200 mg/1
"Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electr
ical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA]"
0228-2167_eaa14eb1-3ca5-4803-9bf7-8fb5766dd373 0228-2167 HUMAN PRESCRIPTI
ON DRUG Levetiracetam Levetiracetam "TABLET, FILM COATED" ORAL
20110404 ANDA ANDA090484 Actavis Elizabeth LLC LEVETIRA
0228-2269_b7140a9b-60f5-4416-8156-ffa257188f81 0228-2269 HUMAN PRESCRIPTI
ON DRUG Metoclopramide Metoclopramide TABLET ORAL 19851017
ANDA ANDA070581 Actavis Elizabeth LLC METOCLOPRAMIDE HYDROCHLORIDE
10 mg/1 "Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [E
PC]"
0228-2348_c66868e0-bc5b-42b6-826e-a538a3e7dc09 0228-2348 HUMAN PRESCRIPTI
ON DRUG Propylthiouracil Propylthiouracil TABLET ORAL
20060115 ANDA ANDA080172 Actavis Elizabeth LLC PROPYLTH
IOURACIL 50 mg/1 "Thyroid Hormone Synthesis Inhibitor [EPC],Thyro
id Hormone Synthesis Inhibitors [MoA]"
0228-2497_f804d060-a333-42dd-b0af-5ba7e79e59b0 0228-2497 HUMAN PRESCRIPTI
ON DRUG Nifedipine Nifedipine "CAPSULE, LIQUID FILLED"
NIFEDIPINE 10 mg/1 "Calcium Channel Antagonists [MoA],Dihydropyridi
0228-2530_f804d060-a333-42dd-b0af-5ba7e79e59b0 0228-2530 HUMAN PRESCRIPTI
NIFEDIPINE 20 mg/1 "Calcium Channel Antagonists [MoA],Dihydropyridi
0228-2538_4985bff5-a00d-4d7b-9c45-ac8a2285d49a 0228-2538 HUMAN PRESCRIPTI
ON DRUG Carbidopa and levodopa Carbidopa and levodopa TABLET ORAL
19930901 ANDA ANDA074260 Actavis Elizabeth LLC CARBIDOP
A; LEVODOPA 10; 100 mg/1; mg/1 "Aromatic Amino Acid Decarboxylation Inh
ibitor [EPC],DOPA Decarboxylase Inhibitors [MoA]"
0228-2550_d2e24428-678e-4749-ba75-fcbc0cfd1153 0228-2550 HUMAN PRESCRIPTI
ON DRUG Diclofenac Sodium Diclofenac Sodium "TABLET, DELAYED
RELEASE" ORAL 19960326 ANDA ANDA074514 Actavis
Elizabeth LLC DICLOFENAC SODIUM 50 mg/1 "Cyclooxygenase Inhibito
rs [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory
Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]"
0228-2551_d2e24428-678e-4749-ba75-fcbc0cfd1153 0228-2551 HUMAN PRESCRIPTI
Elizabeth LLC DICLOFENAC SODIUM 75 mg/1 "Cyclooxygenase Inhibito
0228-2571_f1208bc6-d41d-4cb1-8552-16ea535cd4f8 0228-2571 HUMAN PRESCRIPTI
ON DRUG Indapamide Indapamide "TABLET, FILM COATED" ORAL
20070102 ANDA ANDA074722 Actavis Elizabeth LLC INDAPAMI
DE 2.5 mg/1 "Increased Diuresis [PE],Thiazide-like Diuretic [EPC]"
0228-2577_de202a27-3127-4b73-bdcb-7657072f3aa2 0228-2577 HUMAN PRESCRIPTI
0228-2597_f1208bc6-d41d-4cb1-8552-16ea535cd4f8 0228-2597 HUMAN PRESCRIPTI
ON DRUG Indapamide Indapamide "TABLET, FILM COATED" ORAL
20070102 ANDA ANDA074722 Actavis Elizabeth LLC INDAPAMI
DE 1.25 mg/1 "Increased Diuresis [PE],Thiazide-like Diuretic [EPC]"
0228-2620_2bac6cb1-bf1e-4560-9e65-4555124a2290 0228-2620 HUMAN PRESCRIPTI
ON DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET ORAL
19981030 ANDA ANDA075037 Actavis Elizabeth LLC ISOSORBI
DE MONONITRATE 20 mg/1 "Nitrate Vasodilator [EPC],Nitrates [Chemical/In
gredient],Vasodilation [PE]"
0228-2631_2bac6cb1-bf1e-4560-9e65-4555124a2290 0228-2631 HUMAN PRESCRIPTI
ON DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET ORAL
19981030 ANDA ANDA075037 Actavis Elizabeth LLC ISOSORBI
DE MONONITRATE 10 mg/1 "Nitrate Vasodilator [EPC],Nitrates [Chemical/In
0228-2636_6530638c-15e1-44ca-bcc0-cc327be32ffc 0228-2636 HUMAN PRESCRIPTI
ON DRUG Gabapentin Gabapentin "TABLET, FILM COATED" ORAL
20040214 ANDA ANDA075694 Actavis Elizabeth LLC GABAPENT
IN 600 mg/1 "Anti-epileptic Agent [EPC],Decreased Central Nervous Sy
0228-2637_6530638c-15e1-44ca-bcc0-cc327be32ffc 0228-2637 HUMAN PRESCRIPTI
20040214 ANDA ANDA075694 Actavis Elizabeth LLC GABAPENT
0228-2665_1575f255-97a3-4916-8f80-3cffa1ae9f75 0228-2665 HUMAN PRESCRIPTI
ON DRUG Gabapentin Gabapentin CAPSULE ORAL 20041004
ANDA ANDA075350 Actavis Elizabeth LLC GABAPENTIN 100 mg/1
ical Activity [PE]"
ical Activity [PE]"
ical Activity [PE]"
0228-2672_262387ed-4c75-4b34-a33b-64ff8eb0a936 0228-2672 HUMAN PRESCRIPTI
ON DRUG Spironolactone Spironolactone "TABLET, FILM COATED" ORAL
20070103 ANDA ANDA040353 Actavis Elizabeth LLC SPIRONOL
ACTONE 50 mg/1 "Aldosterone Antagonist [EPC],Aldosterone Antagonists [M
oA]"
oA]"
0228-2717_3e663693-6ed7-48a1-aa41-8b7f74e30af0 0228-2717 HUMAN PRESCRIPTI
ON DRUG Diclofenac Sodium Diclofenac Sodium "TABLET, FILM CO
ATED, EXTENDED RELEASE" ORAL 20020109 ANDA ANDA075910
Actavis Elizabeth LLC DICLOFENAC SODIUM 100 mg/1 "Cyclooxygenase
Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-infla
mmatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC
]"
0228-2751_d8ec845e-5794-47ca-a855-0424a836399f 0228-2751 HUMAN PRESCRIPTI
ON DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin
Hydrochloride "TABLET, FILM COATED" ORAL 20050628 ANDA
ANDA076716 Actavis Elizabeth LLC GLYBURIDE; METFORMIN HYDROCHLORIDE
1.25; 250 mg/1; mg/1 "Sulfonylurea [EPC],Sulfonylurea Compounds [Chem
ical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient]"
2.5; 500 mg/1; mg/1 "Sulfonylurea [EPC],Sulfonylurea Compounds [Chem
5; 500 mg/1; mg/1 "Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ing
redient],Biguanide [EPC],Biguanides [Chemical/Ingredient]"
0228-2778_3336ccaf-16dd-49a2-a3ff-15840674a3e2 0228-2778 HUMAN PRESCRIPTI
ON DRUG Propranolol Hydrochloride Propranolol Hydrochloride
"CAPSULE, EXTENDED RELEASE" ORAL 20070810 ANDA ANDA0784
94 Actavis Elizabeth LLC PROPRANOLOL HYDROCHLORIDE 60 mg/1
"Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]"
0228-2801_2f444b6e-4806-48f6-9278-a0a4a6703e2a 0228-2801 HUMAN PRESCRIPTI
ON DRUG Pilocarpine hydrochloride Pilocarpine hydrochloride
"TABLET, FILM COATED" ORAL 20110913 NDA NDA020327
Actavis Elizabeth LLC PILOCARPINE HYDROCHLORIDE 5 mg/1 "Choline
rgic Agonists [MoA],Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor A
gonist [EPC]"
oA]"
0228-2820_5b0ffd43-8907-4660-ab09-548fa2ea1b32 0228-2820 HUMAN PRESCRIPTI
20070312 ANDA ANDA040707 Actavis Elizabeth LLC HYDROCHL
OROTHIAZIDE 12.5 mg/1 "Increased Diuresis [PE],Thiazide Diuretic [EPC]
0228-2837_2f444b6e-4806-48f6-9278-a0a4a6703e2a 0228-2837 HUMAN PRESCRIPTI
ON DRUG Pilocarpine hydrochloride Pilocarpine hydrochloride
Actavis Elizabeth LLC PILOCARPINE HYDROCHLORIDE 7.5 mg/1 "Choline
rgic Agonists [MoA],Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor A
gonist [EPC]"
0228-2878_c088a64a-27ad-41f0-8a19-797fa0e30a90 0228-2878 HUMAN PRESCRIPTI
ON DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL
20101224 ANDA ANDA076636 Actavis Elizabeth LLC OXYCODON
E HYDROCHLORIDE 15 mg/1 "Full Opioid Agonists [MoA],Opioid Agonist [EPC]
" CII
0228-2879_c088a64a-27ad-41f0-8a19-797fa0e30a90 0228-2879 HUMAN PRESCRIPTI
20101224 ANDA ANDA076636 Actavis Elizabeth LLC OXYCODON
" CII
0228-2890_68a237d9-fda8-459e-82f9-82816e3cf0a6 0228-2890 HUMAN PRESCRIPTI
ON DRUG Duloxetine Duloxetine "CAPSULE, DELAYED RELEASE"
DULOXETINE HYDROCHLORIDE 20 mg/1 "Norepinephrine Uptake Inhibitor
s [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake I
nhibitors [MoA]"
nhibitors [MoA]"
nhibitors [MoA]"
0228-2895_68e794e6-bf7b-4082-8f2c-dd014c413e7e 0228-2895 HUMAN PRESCRIPTI
ON DRUG Doxycycline hyclate Doxycycline hyclate "TABLET, DELAYED
Elizabeth LLC DOXYCYCLINE HYCLATE 75 mg/1
0228-2896_68e794e6-bf7b-4082-8f2c-dd014c413e7e 0228-2896 HUMAN PRESCRIPTI
ON DRUG Doxycycline hyclate Doxycycline hyclate "TABLET, DELAYED
Elizabeth LLC DOXYCYCLINE HYCLATE 100 mg/1
0228-2898_9b3f2744-b1b1-4763-bbd0-363135155417 0228-2898 HUMAN PRESCRIPTI
ON DRUG Glipizide ER Glipizide "TABLET, EXTENDED RELEASE"
GLIPIZIDE 2.5 mg/1 "Sulfonylurea [EPC],Sulfonylurea Compounds [Chem
ical/Ingredient]"
GLIPIZIDE 5 mg/1 "Sulfonylurea [EPC],Sulfonylurea Compounds [Chem
ical/Ingredient]"
GLIPIZIDE 10 mg/1 "Sulfonylurea [EPC],Sulfonylurea Compounds [Chem
ical/Ingredient]"
0228-2918_f88d5ad4-6a73-4283-8881-93f7fa508233 0228-2918 HUMAN PRESCRIPTI
0228-2975_8442b580-9b3a-4e99-b221-d1ef586e8a14 0228-2975 HUMAN PRESCRIPTI
ON DRUG Levetiracetam Levetiracetam "TABLET, FILM COATED, EXTENDED R
ELEASE" ORAL 20110912 ANDA ANDA091557 Actavis Elizabet
h LLC LEVETIRACETAM 750 mg/1 "Anti-epileptic Agent [EPC],Decreased Ce
ntral Nervous System Disorganized Electrical Activity [PE]"
0228-2980_be9faa27-1a3c-4a95-a270-65f678d078a1 0228-2980 HUMAN PRESCRIPTI
ON DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen
TABLET ORAL 20131210 ANDA ANDA201447 Actavis Elizabet
h LLC ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 2.5 mg/1; mg/1
"Full Opioid Agonists [MoA],Opioid Agonist [EPC]" CII
h LLC ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 5 mg/1; mg/1 "Full Op
ioid Agonists [MoA],Opioid Agonist [EPC]" CII
h LLC ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 7.5 mg/1; mg/1
h LLC ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 10 mg/1; mg/1 "Full Op
0228-2996_ab8b786d-8c2b-4946-886a-844722affea3 0228-2996 HUMAN PRESCRIPTI
ON DRUG Tamsulosin hydrochloride Tamsulosin hydrochloride
CAPSULE ORAL 20100427 ANDA ANDA078801 Actavis Elizabet
h LLC TAMSULOSIN HYDROCHLORIDE 0.4 mg/1 "Adrenergic alpha-Antago
nists [MoA],alpha-Adrenergic Blocker [EPC]"
0228-3003_cdfd5711-1a1c-4b55-bf11-84ba17a0e2a3 0228-3003 HUMAN PRESCRIPTI
ON DRUG Clonazepam Clonazepam TABLET ORAL 20090213
ANDA ANDA074869 Actavis Elizabeth LLC CLONAZEPAM 0.5 mg/1
ANDA ANDA074869 Actavis Elizabeth LLC CLONAZEPAM 1 mg/1
ANDA ANDA074869 Actavis Elizabeth LLC CLONAZEPAM 2 mg/1
0228-3059_483e656b-8c6a-421b-98ad-1d4dc9973059 0228-3059 HUMAN PRESCRIPTI
ON DRUG "Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextro
amphetamine sulfate, amphetamine sulfate" "Dextroamphetamine sacch
arate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine
sulfate" "CAPSULE, EXTENDED RELEASE" ORAL 20121210
ANDA ANDA077302 Actavis Elizabeth LLC AMPHETAMINE ASPARTATE MONOHYDRAT
E; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
2.5; 2.5; 2.5; 2.5 mg/1; mg/1; mg/1; mg/1 "Central Nervous System Stimulan
t [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant
[EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant
[EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [
EPC],Central Nervous System Stimulation [PE]" CII
5; 5; 5; 5 mg/1; mg/1; mg/1; mg/1 "Central Nervous System Stimulant [EPC],
Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],C
entral Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Ce
ntral Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Cen
tral Nervous System Stimulation [PE]" CII
0228-3083_a0369a8e-0e24-4db5-ad39-6f339553f323 0228-3083 HUMAN PRESCRIPTI
ON DRUG Alprazolam Extended Release Alprazolam "TABLET, EXTENDE
D RELEASE" ORAL 20070213 ANDA ANDA078056 Actavis
Elizabeth LLC ALPRAZOLAM 0.5 mg/1 "Benzodiazepine [EPC],Benzodiaze
pines [Chemical/Ingredient]" CIV
Elizabeth LLC ALPRAZOLAM 1 mg/1 "Benzodiazepine [EPC],Benzodiaze
0228-3090_e2af88d3-a82e-4624-af1e-656631b485f4 0228-3090 HUMAN PRESCRIPTI
ON DRUG Morphine sulfate Morphine sulfate "CAPSULE, EXTEND
Elizabeth LLC MORPHINE SULFATE 30 mg/1 "Full Opioid Agonists [M
oA],Opioid Agonist [EPC]" CII
0228-3154_09b7ced1-dcc2-46c1-9099-386579c5c57d 0228-3154 HUMAN PRESCRIPTI
ON DRUG Buprenorphine hydrochloride and naloxone hydrochloride dihydrate
Buprenorphine hydrochloride and naloxone hydrochloride dihydrate TABLET
SUBLINGUAL 20130304 ANDA ANDA091422 Actavis Elizabet
h LLC BUPRENORPHINE; NALOXONE 2; .5 mg/1; mg/1 "Partial Opioid Agonist
[EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [
MoA]" CIII
0228-3155_09b7ced1-dcc2-46c1-9099-386579c5c57d 0228-3155 HUMAN PRESCRIPTI
ON DRUG Buprenorphine hydrochloride and naloxone hydrochloride dihydrate
Buprenorphine hydrochloride and naloxone hydrochloride dihydrate TABLET
SUBLINGUAL 20130304 ANDA ANDA091422 Actavis Elizabet
h LLC BUPRENORPHINE; NALOXONE 8; 2 mg/1; mg/1 "Partial Opioid Agonist
[EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [
MoA]" CIII
0228-3227_882aee70-9ebb-41b4-a4db-98c691f47e72 0228-3227 HUMAN PRESCRIPTI
ON DRUG Oxymorphone hydrochloride Oxymorphone hydrochloride
"TABLET, EXTENDED RELEASE" ORAL 20101231 ANDA ANDA0790
46 Actavis Elizabeth LLC OXYMORPHONE HYDROCHLORIDE 5 mg/1
46 Actavis Elizabeth LLC OXYMORPHONE HYDROCHLORIDE 7.5 mg/1
0228-3481_e87f49b8-c90f-4001-9219-505ef0e3948b 0228-3481 HUMAN PRESCRIPTI
ON DRUG Zolpidem Tartrate Zolpidem Tartrate "TABLET, FILM CO
Actavis Elizabeth LLC ZOLPIDEM TARTRATE 6.25 mg/1 "gamma-Aminobuty
ric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredien
t],Central Nervous System Depression [PE]" CIV
0228-3482_e87f49b8-c90f-4001-9219-505ef0e3948b 0228-3482 HUMAN PRESCRIPTI
Actavis Elizabeth LLC ZOLPIDEM TARTRATE 12.5 mg/1 "gamma-Aminobuty
ric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredien
t],Central Nervous System Depression [PE]" CIV
0228-3501_390f3979-3d04-4fe2-b06a-ead95875fdfe 0228-3501 HUMAN PRESCRIPTI
ED RELEASE" ORAL 20111111 NDA AUTHORIZED GENERIC NDA02061
6 Actavis Elizabeth LLC MORPHINE SULFATE 10 mg/1 "Full Op
0228-4019_f218dc4e-0a8e-4670-a0b7-30cee7147587 0228-4019 HUMAN PRESCRIPTI
ON DRUG Alprazolam Alprazolam "TABLET, ORALLY DISINTEGRATING"
ALPRAZOLAM 0.25 mg/1 "Benzodiazepine [EPC],Benzodiazepines [Chemical/
Ingredient]" CIV
Ingredient]" CIV
ALPRAZOLAM 1 mg/1 "Benzodiazepine [EPC],Benzodiazepines [Chemical/
Ingredient]" CIV
Ingredient]" CIV
0228-4029_36f62898-717f-41c4-b956-09029902584d 0228-4029 HUMAN PRESCRIPTI
ON DRUG Oxycodone hydrochloride and Ibuprofen Oxycodone hydrochloride
and Ibuprofen "TABLET, FILM COATED" ORAL 20081104 ANDA
ANDA078769 Actavis Elizabeth LLC IBUPROFEN; OXYCODONE HYDROCHLORIDE
400; 5 mg/1; mg/1 "Full Opioid Agonists [MoA],Opioid Agonist [EPC],Cycloox
ygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingr
edient],Nonsteroidal Anti-inflammatory Drug [EPC]" CII
0228-4417_8442b580-9b3a-4e99-b221-d1ef586e8a14 0228-4417 HUMAN PRESCRIPTI
ON DRUG Levetiracetam Levetiracetam "TABLET, FILM COATED, EXTENDED R
ELEASE" ORAL 20110912 ANDA ANDA091557 Actavis Elizabet
h LLC LEVETIRACETAM 500 mg/1 "Anti-epileptic Agent [EPC],Decreased Ce
45963-460_16cb41cf-11ea-4a42-a396-a8572ccaba04 45963-460 HUMAN PRESCRIPTI
ON DRUG Lansoprazole Lansoprazole "CAPSULE, DELAYED RELEASE"
ORAL 20121218 ANDA ANDA201921 Actavis Inc LANSOPRA
ZOLE 15 mg/1 "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA
]"
45963-461_16cb41cf-11ea-4a42-a396-a8572ccaba04 45963-461 HUMAN PRESCRIPTI
ORAL 20121218 ANDA ANDA201921 Actavis Inc LANSOPRA
]"
45963-125_888843f6-142a-4e1a-92e7-946e07ed30de 45963-125 HUMAN OTC DRUG
Infants Ibuprofen concetrated ibuprofen SUSPENSION ORAL
20100520 ANDA ANDA079058 Actavis Inc. IBUPROFEN
50 mg/1.25mL
45963-152_7683c07c-18cf-4cd4-ab8b-a26989885634 45963-152 HUMAN PRESCRIPTI
ON DRUG Nifedipine Nifedipine "TABLET, EXTENDED RELEASE"
ORAL 20120529 ANDA ANDA077899 Actavis Inc. NIFEDIPI
NE 90 mg/1 "Calcium Channel Antagonists [MoA],Dihydropyridine Calci
um Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient]"
45963-293_207ccf79-1327-46d0-8a42-70e6179171e3 45963-293 HUMAN PRESCRIPTI
ON DRUG Trimipramine maleate Trimipramine maleate CAPSULE ORAL
20111121 ANDA ANDA077361 Actavis Inc. TRIMIPRAMINE MAL
EATE 25 mg/1 Tricyclic Antidepressant [EPC]
45963-341_d438032d-18b9-4129-b707-ee01b1edcee2 45963-341 HUMAN PRESCRIPTI
ON DRUG Desipramine Hydrochloride Desipramine Hydrochloride
Actavis Inc. DESIPRAMINE HYDROCHLORIDE 10 mg/1 Tricyclic Antide
pressant [EPC]
pressant [EPC]
pressant [EPC]
pressant [EPC]
pressant [EPC]
pressant [EPC]
45963-412_e3717ad1-2c17-4f4d-afc0-ad6b68595323 45963-412 HUMAN PRESCRIPTI
ON DRUG Hydrocortisone and Acetic Acid Hydrocortisone and Acetic Acid
SOLUTION AURICULAR (OTIC) 20090629 ANDA ANDA0871
43 Actavis Inc. ACETIC ACID; HYDROCORTISONE 2.41; 3.15 g/100mL;
g/100mL "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [
MoA]"
45963-438_47f6d61a-1abd-45ef-b299-94a10a27bb58 45963-438 HUMAN PRESCRIPTI
ON DRUG Enulose Lactulose SOLUTION ORAL; RECTAL 20110228
ANDA ANDA090502 Actavis Inc. LACTULOSE 10 g/15mL "Osmotic
Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Lar
ge Intestine Fluid/Electrolyte Secretion [PE]"
45963-439_16ed7f67-42ec-4e5e-bfc4-8e7e31eb9c50 45963-439 HUMAN PRESCRIPTI
ON DRUG Constulose Lactulose SOLUTION ORAL 20110228
ANDA ANDA090503 Actavis Inc. LACTULOSE 10 g/15mL "Osmotic
Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Lar
ge Intestine Fluid/Electrolyte Secretion [PE]"
45963-500_dd660c0b-6d1e-4b7a-bb39-74afaba8a313 45963-500 HUMAN PRESCRIPTI
20070328 ANDA ANDA077914 Actavis Inc. FINASTERIDE
5 mg/1 "5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors
[MoA]"
45963-538_4a9c8930-383b-4d5a-a36e-88409b857d41 45963-538 HUMAN PRESCRIPTI
ON DRUG Ondansetron Ondansetron "TABLET, FILM COATED" ORAL
20070727 ANDA ANDA077851 Actavis Inc. ONDANSETRON HYDR
OCHLORIDE 4 mg/1 "Serotonin 3 Receptor Antagonists [MoA],Serotoni
n-3 Receptor Antagonist [EPC]"
45963-539_4a9c8930-383b-4d5a-a36e-88409b857d41 45963-539 HUMAN PRESCRIPTI
ON DRUG Ondansetron Ondansetron "TABLET, FILM COATED" ORAL
20070727 ANDA ANDA077851 Actavis Inc. ONDANSETRON HYDR
OCHLORIDE 8 mg/1 "Serotonin 3 Receptor Antagonists [MoA],Serotoni
45963-555_e3189f16-0d74-4422-89a6-9427d71130fd 45963-555 HUMAN PRESCRIPTI
ANDA ANDA075350 Actavis Inc. GABAPENTIN 100 mg/1 "Anti-ep
ivity [PE]"
ivity [PE]"
ivity [PE]"
45963-558_fa97145a-0a72-40cc-8b22-965b00bf65be 45963-558 HUMAN PRESCRIPTI
ON DRUG Valacyclovir hydrochloride Valacyclovir hydrochloride
Actavis Inc. VALACYCLOVIR HYDROCHLORIDE 500 mg/1 "DNA Polymerase
Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor
[EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herp
esvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chem
ical/Ingredient]"
45963-559_fa97145a-0a72-40cc-8b22-965b00bf65be 45963-559 HUMAN PRESCRIPTI
ON DRUG Valacyclovir hydrochloride Valacyclovir hydrochloride
Actavis Inc. VALACYCLOVIR HYDROCHLORIDE 1 g/1 "DNA Polymerase
ical/Ingredient]"
45963-561_8020b243-6d85-4443-97bf-51a032cee058 45963-561 HUMAN PRESCRIPTI
ON DRUG Donepezil hydrochloride Donepezil hydrochloride "TABLET, FILM CO
ATED" ORAL 20110531 ANDA ANDA090551 Actavis Inc.
DONEPEZIL HYDROCHLORIDE 10 mg/1 "Cholinesterase Inhibitor [EPC],Cholines
terase Inhibitors [MoA]"
45963-569_5d44f837-7c3d-40e8-b33b-5abd82fcaab7 45963-569 HUMAN PRESCRIPTI
ON DRUG Pantoprazole Sodium Pantoprazole Sodium "TABLET, DELAYED
Inc. PANTOPRAZOLE SODIUM 20 mg/1 "Proton Pump Inhibitor [EPC],Pro
ton Pump Inhibitors [MoA]"
45963-570_5d44f837-7c3d-40e8-b33b-5abd82fcaab7 45963-570 HUMAN PRESCRIPTI
Inc. PANTOPRAZOLE SODIUM 40 mg/1 "Proton Pump Inhibitor [EPC],Pro
45963-600_84578df0-d7b4-4c1c-ad27-5b40a7279d9c 45963-600 HUMAN PRESCRIPTI
ON DRUG FINASTERIDE FINASTERIDE "TABLET, FILM COATED" ORAL
20131105 ANDA ANDA078371 Actavis Inc. FINASTERIDE
[MoA]"
45963-633_d4c3c78a-3959-434a-857e-1161becbd0d5 45963-633 HUMAN PRESCRIPTI
ON DRUG Lovastatin Lovastatin TABLET ORAL 20011217
ANDA ANDA075828 Actavis Inc. LOVASTATIN 10 mg/1 "HMG-CoA
Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"
45963-753_6ad1e10f-1069-4960-96a2-48ddf6662d36 45963-753 HUMAN PRESCRIPTI
ON DRUG Glyburide (micronized) and Metformin Hydrochloride Glyburid
e (micronized) and Metformin Hydrochloride TABLET ORAL 20110622
ANDA ANDA076716 Actavis Inc. GLYBURIDE; METFORMIN HYDROCHLORIDE
5; 500 mg/1; mg/1 "Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ing
redient],Biguanide [EPC],Biguanides [Chemical/Ingredient]"
45963-811_fd1ac84d-ddca-491c-bb16-05ac5ab23a84 45963-811 HUMAN PRESCRIPTI
ON DRUG Indomethacin Indomethacin "CAPSULE, EXTENDED RELEASE"
ORAL 20131217 ANDA ANDA202572 Actavis Inc. INDOMETH
ACIN 75 mg/1 "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-infla
]"
45963-833_430825ee-a548-4745-987f-5e1c0f4a4dd7 45963-833 HUMAN PRESCRIPTI
ON DRUG Dexmethylphenidate hydrochloride Dexmethylphenidate hydro
chloride "CAPSULE, EXTENDED RELEASE" ORAL 20140224
ANDA ANDA079108 Actavis Inc. DEXMETHYLPHENIDATE HYDROCHLORIDE
30 mg/1 "Central Nervous System Stimulant [EPC],Central Nervous System S
timulation [PE]" CII
46987-322_b3a7cdbc-53b9-43e8-a7d1-949bac38350c 46987-322 HUMAN PRESCRIPTI
ON DRUG Kadian morphine sulfate "CAPSULE, EXTENDED RELEASE"
ORAL 20090407 NDA NDA020616 Actavis Kadian LLC
MORPHINE SULFATE 20 mg/1 "Full Opioid Agonists [MoA],Opioid Agoni
st [EPC]" CII
st [EPC]" CII
st [EPC]" CII
st [EPC]" CII
st [EPC]" CII
st [EPC]" CII
st [EPC]" CII
st [EPC]" CII
st [EPC]" CII
st [EPC]" CII
st [EPC]" CII
st [EPC]" CII
0472-0013_45541f8f-b5ae-4826-916f-3670d7c3c374 0472-0013 HUMAN PRESCRIPTI
ON DRUG Griseofulvin Griseofulvin SUSPENSION ORAL 20070726
ANDA ANDA065394 Actavis Mid Atlantic LLC GRISEOFULVIN 125
mg/5mL "Decreased Mitosis [PE],Microtubule Inhibition [PE],Tubulin Inhibiting A
gent [EPC]"
0472-0066_d4a6b075-aa43-4784-b019-b1599f0dbd59 0472-0066 HUMAN OTC DRUG
Hair Regrowth Treatment minoxidil SOLUTION TOPICAL 20000101
ANDA ANDA074588 Actavis Mid Atlantic LLC MINOXIDIL 2
g/100mL
0472-0082_782d5d91-94cf-42fe-865a-a7ecf4da8de6 0472-0082 HUMAN PRESCRIPTI
ON DRUG Acyclovir Acyclovir SUSPENSION ORAL 20020903
ANDA ANDA074738 Actavis Mid Atlantic LLC ACYCLOVIR 200
mg/5mL "DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog
DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymer
ase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]
,Nucleoside Analog [Chemical/Ingredient]"
0472-0094_7a70404b-5f49-4fb5-b6db-cb31f8aa987c 0472-0094 HUMAN OTC DRUG
Hair Regrowth Treatment For Men minoxidil SOLUTION TOPICAL
20001117 ANDA ANDA075518 Actavis Mid Atlantic LLC
MINOXIDIL 50 mg/mL
0472-0117_8f65b6e4-92c6-4875-b216-4b3ae2a291d8 0472-0117 HUMAN PRESCRIPTI
ON DRUG Tretinoin Tretinoin CREAM TOPICAL 19980501
NDA AUTHORIZED GENERIC NDA020404 Actavis Mid Atlantic LLC TRETINOI
N 0.25 mg/g "Retinoid [EPC],Retinoids [Chemical/Ingredient]"
0472-0163_69a911e4-927e-4953-af34-0ad2cef1eec9 0472-0163 HUMAN PRESCRIPTI
ON DRUG Nystatin Nystatin CREAM TOPICAL 20100721
ANDA ANDA062949 Actavis Mid Atlantic LLC NYSTATIN 100000
[USP'U]/g "Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient]"
0472-0166_41a98c36-0d72-4cfe-a5fa-ba39df58439b 0472-0166 HUMAN PRESCRIPTI
ON DRUG Nystatin Nystatin OINTMENT TOPICAL 20020903
ANDA ANDA062840 Actavis Mid Atlantic LLC NYSTATIN 100000
0472-0179_c7e2f711-7e1d-4bc8-b4e2-c19f2de8023a 0472-0179 HUMAN OTC DRUG
TRIPLE ANTIBIOTIC bacitracin zinc neomycin sulfate polymyxin b sul
fate OINTMENT TOPICAL 20030101 OTC MONOGRAPH FINAL
part333B Actavis Mid Atlantic LLC BACITRACIN ZINC; NEOMYCIN SULFAT
0472-0220_6903173d-f13b-4e6d-bbe4-6cccaeb6a61c 0472-0220 HUMAN OTC DRUG
Clotrimazole clotrimazole CREAM VAGINAL 20030812
ANDA ANDA074165 Actavis Mid Atlantic LLC CLOTRIMAZOLE 1
g/100g
0472-0235_90764e97-7fa6-4f8c-8087-323b23ddc1be 0472-0235 HUMAN PRESCRIPTI
ON DRUG Levetiracetam Levetiracetam SOLUTION ORAL 20090115
ANDA ANDA078976 Actavis Mid Atlantic LLC LEVETIRACETAM 100
mg/mL "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganize
0472-0242_fc7b7123-1b57-4010-a534-3e3adc5a75ce 0472-0242 HUMAN PRESCRIPTI
ON DRUG Permethrin Permethrin CREAM TOPICAL 20041130
ANDA ANDA074806 Actavis Mid Atlantic LLC PERMETHRIN 50
mg/g "Pyrethrins [Chemical/Ingredient],Pyrethroid [EPC]"
0472-0321_af026b48-2834-4cf8-8360-8da90e184940 0472-0321 HUMAN PRESCRIPTI
ON DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20020103
ANDA ANDA087795 Actavis Mid Atlantic LLC HYDROCORTISONE 10
mg/g "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]"
0472-0337_6c742084-083f-45e8-bfbd-e571b77551dc 0472-0337 HUMAN PRESCRIPTI
0472-0339_7a2fb192-c352-406f-9a3e-d68d053656d8 0472-0339 HUMAN OTC DRUG
Hydrocortisone with Aloe Maximum Strength Hydrocortisone CREAM
TOPICAL 19980708 OTC MONOGRAPH NOT FINAL part348 Actavis Mid Atla
ntic LLC HYDROCORTISONE 1 g/100g
0472-0343_b43f8320-10eb-4c15-8488-09b971ac007a 0472-0343 HUMAN OTC DRUG
Hydrocortisone Maximum Strength Hydrocortisone CREAM TOPICAL 19970801
OTC MONOGRAPH NOT FINAL part348 Actavis Mid Atlantic LLC HYDROCORTISONE
1 g/100g
0472-0345_9c5b6789-f185-4a89-88f3-0903bde6a6d3 0472-0345 HUMAN OTC DRUG
Hydrocortisone Maximum Strength Hydrocortisone OINTMENT TOPICAL
19980901 OTC MONOGRAPH NOT FINAL part348 Actavis Mid Atlantic LLC
HYDROCORTISONE 1 g/100g
0472-0370_cde26ab8-e07c-4264-aab8-c8a2559f8719 0472-0370 HUMAN PRESCRIPTI
ON DRUG Betamethasone Valerate Betamethasone Valerate CREAM TOPICAL
BETAMETHASONE VALERATE 1.2 mg/g "Corticosteroid [EPC],Corticosteroid Hor
0472-0371_cde26ab8-e07c-4264-aab8-c8a2559f8719 0472-0371 HUMAN PRESCRIPTI
ON DRUG Betamethasone Valerate Betamethasone Valerate OINTMENT
TOPICAL 20020901 ANDA ANDA070051 Actavis Mid Atlantic LLC
BETAMETHASONE VALERATE 1.2 mg/g "Corticosteroid [EPC],Corticosteroid Hor
0472-0379_bf85f2b7-3d4c-4ea7-ba8f-18993c3ef329 0472-0379 HUMAN PRESCRIPTI
ON DRUG Clotrimazole and Betamethasone Dipropionate Clotrimazole and
Betamethasone Dipropionate CREAM TOPICAL 20070103 ANDA
ANDA076002 Actavis Mid Atlantic LLC BETAMETHASONE DIPROPIONATE; CLOT
RIMAZOLE .5; 10 mg/g; mg/g "Azole Antifungal [EPC],Azoles [Chemical
/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
"
0472-0380_362287f2-505b-4fa3-bd45-b73c841a982b 0472-0380 HUMAN PRESCRIPTI
ON DRUG Betamethasone Dipropionate betamethasone dipropionate
CREAM TOPICAL 20020903 ANDA ANDA070885 Actavis Mid Atla
ntic LLC BETAMETHASONE DIPROPIONATE 0.5 mg/g "Corticosteroid
[EPC],Corticosteroid Hormone Receptor Agonists [MoA]"
0472-0381_939d2c7f-0b9f-4de6-943f-54835756e3be 0472-0381 HUMAN PRESCRIPTI
ON DRUG Betamethasone Dipropionate Betamethasone Dipropionate
OINTMENT TOPICAL 20020826 ANDA ANDA071012 Actavis
Mid Atlantic LLC BETAMETHASONE DIPROPIONATE 0.5 mg/g "Cortico
steroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]"
0472-0382_11e9f596-fd0e-414d-8828-f27859834294 0472-0382 HUMAN PRESCRIPTI
ON DRUG BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE
"OINTMENT, AUGMENTED" TOPICAL 20070103 ANDA ANDA074304
Actavis Mid Atlantic LLC BETAMETHASONE DIPROPIONATE 0.5 mg/g
"Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]"
0472-0383_10957b03-072c-4a74-81bf-0d3e99bfb93a 0472-0383 HUMAN PRESCRIPTI
ON DRUG Ranitidine Ranitidine SOLUTION ORAL 20070315
ANDA ANDA076124 Actavis Mid Atlantic LLC RANITIDINE HYDROCHLORIDE
15 mg/mL "Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor An
tagonist [EPC]"
0472-0403_320c352f-1585-4820-8a5b-e87124e8c478 0472-0403 HUMAN PRESCRIPTI
ON DRUG Clobetasol Propionate Clobetasol Propionate SHAMPOO TOPICAL
CLOBETASOL PROPIONATE 0.05 g/100mL "Corticosteroid [EPC],Corticosteroid Hor
0472-0404_35cd2027-226e-432e-852e-c591e1926f07 0472-0404 HUMAN PRESCRIPTI
ON DRUG Clobetasol Propionate Clobetasol Propionate LOTION TOPICAL
CLOBETASOL PROPIONATE 0.05 g/100mL "Corticosteroid [EPC],Corticosteroid Hor
0472-0730_bc8e696e-eaa4-453f-8d15-98c4cef76475 0472-0730 HUMAN OTC DRUG
Miconazole 7 Miconazole Nitrate CREAM VAGINAL 20110916
ANDA ANDA074164 Actavis Mid Atlantic LLC MICONAZOLE NITRATE
2 g/100g
0472-0735_c56731a4-97b0-4f2c-9dd8-4da6dfb7e901 0472-0735 HUMAN OTC DRUG
Antifungal miconazole nitrate CREAM TOPICAL 20070501
OTC MONOGRAPH FINAL part333C Actavis Mid Atlantic LLC MICONAZO
LE NITRATE 20 mg/g
0472-0804_e2634f92-7e5a-4840-be47-7e32e0a3d60f 0472-0804 HUMAN PRESCRIPTI
ON DRUG Desonide Desonide CREAM TOPICAL 20130801
NDA AUTHORIZED GENERIC NDA019048 Actavis Mid Atlantic LLC DESONIDE
0.5 mg/g "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [
MoA]"
0472-0829_dd01fd90-413a-4e72-9c88-e858d90f0775 0472-0829 HUMAN PRESCRIPTI
ON DRUG Fluocinonide Fluocinonide SOLUTION TOPICAL 20130722
ANDA ANDA071535 Actavis Mid Atlantic LLC FLUOCINONIDE 0.5
mg/mL "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]"
0472-0882_e8843406-2806-4f9f-83d1-c35999d8ae45 0472-0882 HUMAN PRESCRIPTI
ON DRUG Acetasol HC Hydorcortisone and Acetic Acid SOLUTION
AURICULAR (OTIC) 20020910 ANDA ANDA087143 Actavis
Mid Atlantic LLC ACETIC ACID; HYDROCORTISONE 2.41; 1.1 g/100mL;
g/100mL "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [
MoA]"
0472-1030_9206060a-f9e4-470e-b934-41f99329c218 0472-1030 HUMAN PRESCRIPTI
ON DRUG Hydromet Hydrocodone Bitartate and Homatropine Methylbrom
ide SYRUP ORAL 20081201 ANDA ANDA088017 Actavis
Mid Atlantic LLC HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE
1.5; 5 mg/5mL; mg/5mL "Opioid Agonist [EPC],Opioid Agonists [MoA]" CIII
0472-1105_cf37bb3d-586f-43c3-a544-ba4f850684a5 0472-1105 HUMAN OTC DRUG
Bacitracin Zinc bacitracin zinc OINTMENT TOPICAL 20020301
OTC MONOGRAPH FINAL part333B Actavis Mid Atlantic LLC BACITRAC
IN ZINC 500 [USP'U]/g
0472-1200_107ec71c-fe08-4ea0-92a7-244b5386b353 0472-1200 HUMAN OTC DRUG
FeverALL Infants acetaminophen SUPPOSITORY RECTAL 19800401
NDA NDA018337 Actavis Mid Atlantic LLC ACETAMINOPHEN 80
mg/1
0472-1201_0ed6eb34-ecf3-410e-8bed-1e8def9aff6a 0472-1201 HUMAN OTC DRUG
FeverALL Children acetaminophen SUPPOSITORY RECTAL 19800401
mg/1
0472-1202_6c35e0be-0e9e-4315-991c-353a41bde71a 0472-1202 HUMAN OTC DRUG
FeverALL Junior acetaminophen SUPPOSITORY RECTAL 19800401
mg/1
0472-1203_6ba5d432-2db2-47f4-a549-751aa562da09 0472-1203 HUMAN OTC DRUG
FeverALL Adults acetaminophen SUPPOSITORY RECTAL 19800401
mg/1
0472-1255_cac0b4dc-82b2-4057-9a05-3d2c9b1f59ce 0472-1255 HUMAN OTC DRUG
Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20060601
ANDA ANDA074916 Actavis Mid Atlantic LLC IBUPROFEN 100
mg/5mL
mg/5mL
mg/5mL
mg/5mL
0472-1270_1dc0109f-8b89-4d2f-95cc-09e4540cebe8 0472-1270 HUMAN PRESCRIPTI
ON DRUG Ibuprofen Ibuprofen SUSPENSION ORAL 20020927
mg/5mL "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compound
s [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]"
0472-1326_af026b48-2834-4cf8-8360-8da90e184940 0472-1326 HUMAN PRESCRIPTI
ON DRUG Hydrocortisone Hydrocortisone OINTMENT TOPICAL 20030103
0472-1400_1f18da82-08a9-408e-9ffa-7808b996cffc 0472-1400 HUMAN PRESCRIPTI
ON DRUG Cyproheptadine Hydrochloride Cyproheptadine Hydrochloride
SYRUP ORAL 20090731 ANDA ANDA040668 Actavis Mid Atla
ntic LLC CYPROHEPTADINE HYDROCHLORIDE 2 mg/5mL
0472-1627_9943840e-05c9-44da-8f75-a5520fc6c5d2 0472-1627 HUMAN PRESCRIPTI
ON DRUG Prometh with Codeine promethazine hydrochloride and codeine p
hosphate SYRUP ORAL 20030103 ANDA ANDA088763
Actavis Mid Atlantic LLC CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE
10; 6.25 mg/5mL; mg/5mL "Phenothiazine [EPC],Phenothiazines [Chemical/In
gredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC]" CV
0472-1628_29d42c05-aff6-45ed-bc26-014e56345a51 0472-1628 HUMAN PRESCRIPTI
ON DRUG Promethazine hydrochloride and phenylephrine hydrochloride
Promethazine hydrochloride and phenylephrine hydrochloride SYRUP ORAL
PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE 5; 6.25 mg/5mL; mg/5mL
"Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],alpha-1 Adrenergic Ago
nist [EPC],Adrenergic alpha1-Agonists [MoA]"
0472-1629_b0838177-aa10-455d-b969-58967f932f9e 0472-1629 HUMAN PRESCRIPTI
ON DRUG PROMETHAZINE VC WITH CODEINE "PROMETHAZINE HYDROCHLORIDE, PHE
NYLEPHRINE HYDROCHLORIDE AND CODEINE PHOSPHATE" SYRUP ORAL 20111219
ANDA ANDA088764 Actavis Mid Atlantic LLC CODEINE PHOSPHATE; PHENY
LEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE 10; 5; 6.25 mg/5mL;
mg/5mL; mg/5mL "Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],alpha-
1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA],Full Opioid Agonists
[MoA],Opioid Agonist [EPC]" CV
0472-1630_30d54796-9513-4a40-8710-929fc64801f8 0472-1630 HUMAN PRESCRIPTI
ON DRUG Prometh with Dextromethorphan "Promethazine Hydrochloride, Dex
tromethorphan Hydrobromide" SYRUP ORAL 20070103 ANDA
ANDA088762 Actavis Mid Atlantic LLC DEXTROMETHORPHAN HYDROBROMIDE; P
ROMETHAZINE HYDROCHLORIDE 15; 6.25 mg/5mL; mg/5mL "Phenothiazine [
EPC],Phenothiazines [Chemical/Ingredient],Uncompetitive N-methyl-D-aspartate Rec
eptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagon
ists [MoA],Sigma-1 Receptor Agonists [MoA]"
0472-1736_4dc31658-f5c0-4274-ac6e-e0ef2ec991f7 0472-1736 HUMAN OTC DRUG
Miconazole 7 miconazole nitrate SUPPOSITORY VAGINAL 19931119
ANDA ANDA073507 Actavis Mid Atlantic LLC MICONAZOLE NITRATE
100 mg/1
0472-1738_009711be-7906-4bed-9755-2017a7b7f869 0472-1738 HUMAN PRESCRIPTI
ON DRUG Miconazole Nitrate Miconazole Nitrate SUPPOSITORY
VAGINAL 20020903 ANDA ANDA073508 Actavis Mid Atlantic LLC
MICONAZOLE NITRATE 200 mg/1 "Azole Antifungal [EPC],Azoles [Chemical
/Ingredient]"
0472-3901_9c0e60d3-58c4-254f-9f04-0cec80c222ce 0472-3901 HUMAN PRESCRIPTI
ON DRUG Fluocinonide Fluocinonide CREAM TOPICAL 20140409
ANDA ANDA073085 Actavis Mid Atlantic LLC FLUOCINONIDE 0.5
0472-5002_6ca65822-32d2-4d3b-8ec6-670f968d0869 0472-5002 HUMAN PRESCRIPTI
ON DRUG Phenytoin Phenytoin SUSPENSION ORAL 20090302
ANDA ANDA089892 Actavis Mid Atlantic LLC PHENYTOIN 125
0472-5242_2028c8aa-8562-44e4-978d-9c8a9dba7c0c 0472-5242 HUMAN OTC DRUG
Lice Treatment permethrin LOTION TOPICAL 20100328
ANDA ANDA075014 Actavis Mid Atlantic LLC PERMETHRIN 1
mg/100mL
0472-0912_e1c188fa-7755-4650-a6ab-f696a41766b3 0472-0912 HUMAN PRESCRIPTI
ON DRUG METRONIDAZOLE METRONIDAZOLE LOTION TOPICAL 20090528
NDA NDA020901 "Actavis Mid Atlantic LLC," METRONIDAZOLE 7.5
mg/mL "Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient
]"
0472-0803_6854c529-91fc-4aed-8ad9-8ff032ac5983 0472-0803 HUMAN PRESCRIPTI
ON DRUG DESONIDE DESONIDE LOTION TOPICAL 20090528
ANDA ANDA072354 "Actavis Mid Atlantic LLC, Lincolnton, NC 28092"
DESONIDE 0.5 mg/mL "Corticosteroid [EPC],Corticosteroid Hormone Rec
eptor Agonists [MoA]"
0472-0911_5f6014f9-4a54-47c6-a290-01472e6c0fe7 0472-0911 HUMAN PRESCRIPTI
ON DRUG Metronidazole "Topical Cream, 0.75%" "Metronidazole Topical Cream, 0.
75%" CREAM TOPICAL 20090618 NDA NDA020531 "Actavis
Mid Atlantic LLC, Lincolnton, NC 28092" METRONIDAZOLE 7.5 mg/g
"Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient]"
14550-511_80a68ba3-10c2-41da-a521-2290c669071b 14550-511 HUMAN PRESCRIPTI
ANDA ANDA075350 Actavis Pharma Manufacturing Pvt Ltd. (SOD) GABAPENT
14550-517_e77e640b-d633-4cb4-8ebf-adbf5f35cc43 14550-517 HUMAN PRESCRIPTI
ANDA ANDA076716 Actavis Pharma Manufacturing Pvt. Ltd. GLYBURIDE; METFO
RMIN HYDROCHLORIDE 1.25; 250 mg/1; mg/1 "Sulfonylurea [EPC],Sulf
onylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/In
gredient]"
RMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 "Sulfonylurea [EPC],Sulf
onylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/In
gredient]"
RMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 "Sulfonylurea [EPC],Sulfonylurea
Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient
]"
0591-3196_f0617705-38d2-460b-a329-e916ca655e33 0591-3196 HUMAN PRESCRIPTI
ON DRUG TERCONAZOLE TERCONAZOLE CREAM VAGINAL 20040401
NDA AUTHORIZED GENERIC NDA019579 "Actavis Pharma, Inc" TERCONAZOLE
4 mg/g "Azole Antifungal [EPC],Azoles [Chemical/Ingredient]"
0591-3197_f0617705-38d2-460b-a329-e916ca655e33 0591-3197 HUMAN PRESCRIPTI
ON DRUG TERCONAZOLE TERCONAZOLE CREAM VAGINAL 20040401
NDA AUTHORIZED GENERIC NDA019964 "Actavis Pharma, Inc" TERCONAZOLE
8 mg/g "Azole Antifungal [EPC],Azoles [Chemical/Ingredient]"
0591-0444_b6d09eb1-7490-4c39-9da7-d642f3f893bc 0591-0444 HUMAN PRESCRIPTI
ON DRUG Guanfacine Guanfacine TABLET ORAL 19951017
ANDA ANDA074145 "Actavis Pharma, Inc." GUANFACINE HYDROCHLORIDE
1 mg/1 "Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Ago
nist [EPC]"
0591-0453_b6d09eb1-7490-4c39-9da7-d642f3f893bc 0591-0453 HUMAN PRESCRIPTI
ON DRUG Guanfacine Guanfacine TABLET ORAL 19951017
ANDA ANDA074145 "Actavis Pharma, Inc." GUANFACINE HYDROCHLORIDE
nist [EPC]"
0591-0782_ea48e26c-bc0f-4834-b60a-525a1f9b4647 0591-0782 HUMAN PRESCRIPTI
ON DRUG Diethylpropion HCl Controlled-Release Diethylpropion hydrochlo
ride TABLET ORAL 19601117 NDA NDA012546 "Actavis
Pharma, Inc." DIETHYLPROPION HYDROCHLORIDE 75 mg/1 "Appetite Suppre
ssion [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [
EPC]" CIV
0591-0783_ea48e26c-bc0f-4834-b60a-525a1f9b4647 0591-0783 HUMAN PRESCRIPTI
ON DRUG Diethylpropion HCl Immediate-Release Diethylpropion hydrochlo
ride TABLET ORAL 19590806 NDA NDA011722 "Actavis
Pharma, Inc." DIETHYLPROPION HYDROCHLORIDE 25 mg/1 "Appetite Suppre
EPC]" CIV
0591-0794_3ed3a2b2-cc00-453e-8a04-78fd6890236d 0591-0794 HUMAN PRESCRIPTI
ON DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride
CAPSULE ORAL 19860619 ANDA ANDA085082 "Actavis Pharma,
Inc." DICYCLOMINE HYDROCHLORIDE 10 mg/1 "Anticholinergic [EPC],C
holinergic Antagonists [MoA]"
0591-0795_3ed3a2b2-cc00-453e-8a04-78fd6890236d 0591-0795 HUMAN PRESCRIPTI
TABLET ORAL 19860730 ANDA ANDA085223 "Actavis Pharma,
Inc." DICYCLOMINE HYDROCHLORIDE 20 mg/1 "Anticholinergic [EPC],C
holinergic Antagonists [MoA]"
0591-1117_f8a1f443-a896-4014-87df-fd054928e874 0591-1117 HUMAN PRESCRIPTI
ON DRUG Mirtazapine Mirtazapine "TABLET, FILM COATED" ORAL
20030619 ANDA ANDA076312 "Actavis Pharma, Inc." MIRTAZAP
INE 15 mg/1
INE 30 mg/1
INE 45 mg/1
0591-2044_e87b3955-8563-4fda-9b18-b1a2bd6ea061 0591-2044 HUMAN PRESCRIPTI
ON DRUG risedronate sodium risedronate sodium "TABLET, FILM CO
ATED" ORAL 20140627 NDA AUTHORIZED GENERIC NDA020835
"Actavis Pharma, Inc." RISEDRONATE SODIUM HEMI-PENTAHYDRATE; RISEDRONATE SODIUM
MONOHYDRATE 129; 21 mg/1; mg/1 "Bisphosphonate [EPC],Diphosphonates [Ch
emical/Ingredient],Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient]"
MONOHYDRATE 64.5; 10.5 mg/1; mg/1 "Bisphosphonate [EPC],Diphosphon
ates [Chemical/Ingredient],Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredi
ent]"
0591-2070_e885b52f-3acc-45b9-8a44-4c6e675150b5 0591-2070 HUMAN PRESCRIPTI
ON DRUG Lidocaine and Prilocaine lidocaine and prilocaine
CREAM TOPICAL 20121112 NDA AUTHORIZED GENERIC NDA019941
"Actavis Pharma, Inc." LIDOCAINE; PRILOCAINE 25; 25 mg/g; mg/g "Amide L
ocal Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local An
esthesia [PE],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local An
esthesia [PE]"
ent]"
MONOHYDRATE 4.3; .7 mg/1; mg/1 "Bisphosphonate [EPC],Diphosphonates [Ch
emical/Ingredient],Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient]"
ent]"
0591-2368_e5a0f8bb-5a4c-4a16-82a8-a8117f02b7ca 0591-2368 HUMAN PRESCRIPTI
ON DRUG Ursodiol Ursodiol "TABLET, FILM COATED" ORAL
20111223 ANDA ANDA200826 "Actavis Pharma, Inc." URSODIOL
250 mg/1 "Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient]"
0591-2369_e5a0f8bb-5a4c-4a16-82a8-a8117f02b7ca 0591-2369 HUMAN PRESCRIPTI
ON DRUG Ursodiol Ursodiol "TABLET, FILM COATED" ORAL
20111223 ANDA ANDA200826 "Actavis Pharma, Inc." URSODIOL
500 mg/1 "Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient]"
0591-2693_f58a7973-696c-4c3c-b7d4-145f838d7c81 0591-2693 HUMAN PRESCRIPTI
ON DRUG Oxycodone Hydrochloride oxycodone hydrochloride "TABLET, FILM CO
ATED, EXTENDED RELEASE" ORAL 20140903 NDA AUTHORIZED GENERIC
NDA022272 "Actavis Pharma, Inc." OXYCODONE HYDROCHLORIDE 40 mg/1
0591-2708_f58a7973-696c-4c3c-b7d4-145f838d7c81 0591-2708 HUMAN PRESCRIPTI
ON DRUG Oxycodone Hydrochloride oxycodone hydrochloride "TABLET, FILM CO
NDA022272 "Actavis Pharma, Inc." OXYCODONE HYDROCHLORIDE 80 mg/1
0591-2715_a0c634c8-2514-43bf-84da-8e3b7a61f197 0591-2715 HUMAN PRESCRIPTI
ON DRUG methylphenidate hydrochloride methylphenidate hydrochloride
TABLET ORAL 20110401 NDA AUTHORIZED GENERIC NDA021121
"Actavis Pharma, Inc." METHYLPHENIDATE HYDROCHLORIDE 18 mg/1 "Central
Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]"
CII
CII
CII
CII
0591-2736_d2bddc42-7768-4b27-a872-cfc5c5a93f89 0591-2736 HUMAN PRESCRIPTI
ON DRUG levalbuterol hydrochloride levalbuterol hydrochloride
SOLUTION RESPIRATORY (INHALATION) 20140610 ANDA
ANDA077756 "Actavis Pharma, Inc." LEVALBUTEROL HYDROCHLORIDE 0.31
mg/3mL "Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]"
0591-3202_63617481-16ed-4438-8fcb-c3289434843b 0591-3202 HUMAN PRESCRIPTI
ON DRUG Hydrocodone Bitartate and Acetaminophen Hydrocodone Bitartate an
d Acetaminophen TABLET ORAL 19970625 ANDA ANDA040099
"Actavis Pharma, Inc." ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg
/1 "Opioid Agonist [EPC],Opioid Agonists [MoA]" CIII
0591-3220_eb5bb9b0-09e8-4549-8d93-73bafc0d5fcf 0591-3220 HUMAN PRESCRIPTI
ON DRUG "Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate"
"Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate" CAPSULE ORAL
20031001 NDA AUTHORIZED GENERIC NDA020232 "Actavis Pharma,
Inc." ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE 325; 50; 40; 30
mg/1; mg/1; mg/1; mg/1 "Full Opioid Agonists [MoA],Opioid Agonist [EPC],Barbitu
rate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [
EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Che
mical/Ingredient]" CIII
0591-3369_cb6cb106-7f7d-4ebe-9b96-87cbaee24185 0591-3369 HUMAN PRESCRIPTI
ON DRUG "Butalbital, Acetaminophen, and Caffeine" "Butalbital, Ace
taminophen, and Caffeine" TABLET ORAL 20071213 ANDA
ANDA088616 "Actavis Pharma, Inc." ACETAMINOPHEN; BUTALBITAL; CAFFEINE
325; 50; 40 mg/1; mg/1; mg/1 "Barbiturate [EPC],Barbiturates [Chemica
l/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stim
ulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient]"
16252-514_2c2121ad-1e3e-4315-adc4-122a473396b3 16252-514 HUMAN PRESCRIPTI
ON DRUG Ciprofloxacin Ciprofloxacin "TABLET, FILM COATED" ORAL
20040609 ANDA ANDA076794 "Actavis Pharma, Inc." CIPROFLO
XACIN HYDROCHLORIDE 250 mg/1 "Quinolone Antimicrobial [EPC],Quinolone
s [Chemical/Ingredient]"
45963-303_b8ee0dca-fc9b-4a0f-abff-5bb2348c6ead 45963-303 HUMAN PRESCRIPTI
ON DRUG dextroamphetamine sulfate dextroamphetamine sulfate
01 "Actavis Pharma, Inc." DEXTROAMPHETAMINE SULFATE 5 mg/1
"Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]"
CII
CII
CII
45963-734_26da17c5-ff40-4ac5-8aa1-c7363e6fca4d 45963-734 HUMAN PRESCRIPTI
ON DRUG Docetaxel Docetaxel "INJECTION, SOLUTION, CONCENTRAT
E" INTRAVENOUS 20140901 NDA NDA203551 "Actavis
Pharma, Inc." DOCETAXEL 20 mg/mL "Microtubule Inhibition [PE],Mic
rotubule Inhibitor [EPC]"
45963-743_a74f4bb3-7b0c-4707-9853-b434611fc20e 45963-743 HUMAN PRESCRIPTI
ON DRUG "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine
Sulfate and Amphetamine Sulfate" "Dextroamphetamine Saccharate, A
mphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate"
Inc." AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMIN
E SACCHARATE; DEXTROAMPHETAMINE SULFATE 1.25; 1.25; 1.25; 1.25 mg/1; mg/1; mg/1
; mg/1 "Central Nervous System Stimulant [EPC],Central Nervous System Stimulati
on [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulatio
n [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation
[PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation
[PE]" CII
[PE]" CII
E SACCHARATE; DEXTROAMPHETAMINE SULFATE 5; 5; 5; 5 mg/1; mg/1; mg/1; mg/1
"Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],
Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],C
entral Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Ce
ntral Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]"
CII
[PE]" CII
52544-011_23ea8c06-4e0c-4b34-9a93-bfeedf62a4a0 52544-011 HUMAN PRESCRIPTI
ORAL 20090407 NDA NDA020616 "Actavis Pharma, Inc."
st [EPC]" CII
st [EPC]" CII
st [EPC]" CII
52544-044_5f5514bc-8518-4d83-b6fe-98896adf3044 52544-044 HUMAN PRESCRIPTI
ON DRUG Cordran Flurandrenolide TAPE TOPICAL 19690729
NDA NDA016455 "Actavis Pharma, Inc." FLURANDRENOLIDE 4 ug/cm2
st [EPC]" CII
st [EPC]" CII
52544-076_d42ec1a1-db9e-419e-8b0f-2bf0c4bec189 52544-076 HUMAN PRESCRIPTI
ON DRUG Androderm Testosterone PATCH TRANSDERMAL 19950929
NDA NDA020489 "Actavis Pharma, Inc." TESTOSTERONE 2 mg/d
"Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredien
t]"
52544-077_d42ec1a1-db9e-419e-8b0f-2bf0c4bec189 52544-077 HUMAN PRESCRIPTI
ON DRUG Androderm Testosterone PATCH TRANSDERMAL 19950929
NDA NDA020489 "Actavis Pharma, Inc." TESTOSTERONE 4 mg/d
"Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredien
t]"
52544-092_02d5978a-ae60-48d9-9640-544ced251ce3 52544-092 HUMAN PRESCRIPTI
ON DRUG Trelstar triptorelin pamoate KIT 20100311
NDA NDA022437 "Actavis Pharma, Inc."
ON DRUG Trelstar triptorelin pamoate "INJECTION, POWDER, LYOP
HILIZED, FOR SUSPENSION" INTRAMUSCULAR 20000615 NDA
NDA020715 "Actavis Pharma, Inc." TRIPTORELIN PAMOATE 3.75 mg/2mL
"Gonadotropin Releasing Hormone Receptor Agonist [EPC],Gonadotropin Releasing Ho
rmone Receptor Agonists [MoA]"
st [EPC]" CII
st [EPC]" CII
52544-219_1a9e060e-343a-4534-8c18-b64f3b513226 52544-219 HUMAN PRESCRIPTI
ON DRUG Leena Norethindrone and Ethinyl Estradiol KIT ORAL
20050112 NDA AUTHORIZED GENERIC NDA018977 "Actavis Pharma,
Inc."
st [EPC]" CII
52544-254_8b5e1c8c-bdd2-46fb-96d8-c1cf68a7abbc 52544-254 HUMAN PRESCRIPTI
ON DRUG Brevicon Norethindrone and ethinyl estradiol KIT
19760329 NDA NDA017743 "Actavis Pharma, Inc."
ON DRUG Norinyl Norethindrone and ethinyl estradiol KIT
19741227 NDA NDA017565 "Actavis Pharma, Inc."
ON DRUG Norinyl Norethindrone and Mestranol KIT 19671117
52544-276_5a2e4577-f199-4659-aeae-5e8788229f83 52544-276 HUMAN PRESCRIPTI
ON DRUG Microgestin Norethindrone Acetate and Ethinyl Estradiol
"Actavis Pharma, Inc." ETHINYL ESTRADIOL; NORETHINDRONE ACETATE .02; 1
mg/1; mg/1 "Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Es
trogen [EPC],Estrogen Receptor Agonists [MoA]"
52544-290_5a2e4577-f199-4659-aeae-5e8788229f83 52544-290 HUMAN PRESCRIPTI
ON DRUG Microgestin Norethindrone Acetate and Ethinyl Estradiol
"Actavis Pharma, Inc." ETHINYL ESTRADIOL; NORETHINDRONE ACETATE .03; 1.5
mg/1; mg/1 "Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Es
trogen [EPC],Estrogen Receptor Agonists [MoA]"
52544-471_48991cce-698c-4324-8b2d-44889547369c 52544-471 HUMAN PRESCRIPTI
ON DRUG Alora Estradiol Transdermal System PATCH TRANSDERMAL
19961220 NDA NDA020655 "Actavis Pharma, Inc." ESTRADIO
L 0.05 mg/d "Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC
],Estrogen Receptor Agonists [MoA]"
52544-732_945b27e6-d3eb-419c-9869-440bef54ed31 52544-732 HUMAN PRESCRIPTI
ON DRUG Dilacor XR diltiazem hydrochloride "CAPSULE, EXTENDED RELEASE"
52544-892_ec9d651b-2821-4e7f-8437-1cfe5ee70602 52544-892 HUMAN PRESCRIPTI
ON DRUG Jolivette NORETHINDRONE TABLET ORAL 20030301
NDA NDA016954 "Actavis Pharma, Inc." NORETHINDRONE 0.35 mg/1
"Progesterone Congeners [Chemical/Ingredient],Progestin [EPC]"
st [EPC]" CII
52544-913_cc636b5f-b209-4ab7-b9ef-cd18fdf27288 52544-913 HUMAN PRESCRIPTI
ON DRUG Norco Hydrocodone Bitartate and Acetaminophen TABLET ORAL
19970625 ANDA ANDA040099 "Actavis Pharma, Inc." ACETAMIN
OPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 "Opioid Agonist [EPC],Op
52544-931_aead060b-cb47-4163-a1d8-8829837f2952 52544-931 HUMAN PRESCRIPTI
ON DRUG INFeD Iron Dextran INJECTION INTRAMUSCULAR; INTRAVENO
US 19740429 NDA NDA017441 "Actavis Pharma, Inc."
IRON DEXTRAN 50 mg/mL "Iron [Chemical/Ingredient],Parenteral Iron Repl
acement [EPC]"
67767-117_12698fb6-1b50-4060-8904-bb1c620108d9 67767-117 HUMAN PRESCRIPTI
ON DRUG Bupropion hydrochloride Bupropion hydrochloride "TABLET, EXTENDE
South Atlantic LLC BUPROPION HYDROCHLORIDE 150 mg/1 "Aminoketone [EP
C],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased N
orepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]"
67767-121_cd8585d9-5ea8-444e-9d3b-ee2797c1a90e 67767-121 HUMAN PRESCRIPTI
ON DRUG Fentanyl transdermal system Fentanyl PATCH TRANSDER
MAL 20070820 20140930 ANDA ANDA077062 Actavis South At
lantic LLC FENTANYL 50 ug/h "Full Opioid Agonists [MoA],Opio
id Agonist [EPC]" CII
67767-123_cd8585d9-5ea8-444e-9d3b-ee2797c1a90e 67767-123 HUMAN PRESCRIPTI
ON DRUG Fentanyl transdermal system Fentanyl PATCH TRANSDER
MAL 20070820 20140930 ANDA ANDA077062 Actavis South At
lantic LLC FENTANYL 100 ug/h "Full Opioid Agonists [MoA],Opio
67767-133_9a504cce-efd9-44f7-b67e-00f55a4295c9 67767-133 HUMAN PRESCRIPTI
ON DRUG Bupropion Hydrochloride Bupropion Hydrochloride "TABLET, FILM CO
Actavis South Atlantic LLC BUPROPION HYDROCHLORIDE 150 mg/1 "Aminoke
tone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Inc
reased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]"
67767-141_8d33a46e-5c0b-4af4-ae66-9130f52e9aef 67767-141 HUMAN PRESCRIPTI
ON DRUG Bupropion Hydrochloride Bupropion Hydrochloride "TABLET, EXTENDE
67767-142_8d33a46e-5c0b-4af4-ae66-9130f52e9aef 67767-142 HUMAN PRESCRIPTI
67767-200_937d1bad-0c6a-43ab-8dc7-0bb376054d80 67767-200 HUMAN PRESCRIPTI
ON DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride
58 Actavis South Atlantic LLC METHYLPHENIDATE HYDROCHLORIDE 20
mg/1 "Central Nervous System Stimulant [EPC],Central Nervous System Stimulati
on [PE]" CII
on [PE]" CII
on [PE]" CII
45963-327_e1f208ca-7f3d-496d-ada7-7d936ea43807 45963-327 HUMAN PRESCRIPTI
ON DRUG PHENDIMETRAZINE TARTRATE Phendimetrazine Tartrate
TABLET ORAL 20121120 ANDA ANDA040762 "Actavis, Inc."
PHENDIMETRAZINE TARTRATE 35 mg/1 "Appetite Suppression [PE],Incre
ased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]" CIII
66215-016_169135a6-04bf-48ff-a5c9-8d90baa79bb5 66215-016 HUMAN PRESCRIPTI
ON DRUG VALCHLOR mechlorethamine hydrochloride GEL TOPICAL
20131021 NDA NDA202317 "Actelion Pharmaceuticals US, In
c." MECHLORETHAMINE 0.012 g/60g "Alkylating Activity [MoA],Alkylating Dr
ug [EPC]"
66215-101_569ae365-529f-42d0-a721-f40f4a396e52 66215-101 HUMAN PRESCRIPTI
ON DRUG Tracleer bosentan "TABLET, FILM COATED" ORAL
c." BOSENTAN 62.5 mg/1 "Endothelin Receptor Antagonist [EPC],En
dothelin Receptor Antagonists [MoA]"
66215-102_569ae365-529f-42d0-a721-f40f4a396e52 66215-102 HUMAN PRESCRIPTI
ON DRUG Tracleer bosentan "TABLET, FILM COATED" ORAL
c." BOSENTAN 125 mg/1 "Endothelin Receptor Antagonist [EPC],En
dothelin Receptor Antagonists [MoA]"
66215-201_54c867b3-b9f5-47fa-a845-ec581f855a35 66215-201 HUMAN PRESCRIPTI
ON DRUG Zavesca miglustat CAPSULE ORAL 20030731
NDA NDA021348 "Actelion Pharmaceuticals US, Inc." MIGLUSTAT
100 mg/1 "Glucosylceramide Synthase Inhibitor [EPC],Glucosylceramide Synt
hase Inhibitors [MoA]"
66215-302_4cd9977f-d5eb-4a6e-a833-9e980e807fdb 66215-302 HUMAN PRESCRIPTI
ON DRUG Ventavis iloprost SOLUTION RESPIRATORY (INH
ALATION) 20050507 NDA NDA021779 "Actelion Pharma
ceuticals US, Inc." ILOPROST 0.01 mg/mL "Prostacycline [EPC],Pro
staglandins I [Chemical/Ingredient]"
66215-303_4cd9977f-d5eb-4a6e-a833-9e980e807fdb 66215-303 HUMAN PRESCRIPTI
ON DRUG Ventavis iloprost SOLUTION RESPIRATORY (INH
ALATION) 20090824 NDA NDA021779 "Actelion Pharma
ceuticals US, Inc." ILOPROST 0.02 mg/mL "Prostacycline [EPC],Pro
staglandins I [Chemical/Ingredient]"
66215-401_c21fe239-6ac6-46a2-b97c-84d9ad1a5c98 66215-401 HUMAN PRESCRIPTI
ON DRUG Veletri epoprostenol sodium "INJECTION, POWDER, LYOPHILIZED,
FOR SOLUTION" INTRAVENOUS 20100422 NDA NDA022260
"Actelion Pharmaceuticals US, Inc." EPOPROSTENOL SODIUM 1500000 ng/10mL
"Prostacycline Vasodilator [EPC],Prostaglandins I [Chemical/Ingredient],Vasodila
tion [PE]"
66215-402_2338f36d-d36f-4f71-8584-2490394e7b03 66215-402 HUMAN PRESCRIPTI
ON DRUG Veletri epoprostenol "INJECTION, POWDER, LYOPHILIZED, FOR SOL
UTION" INTRAVENOUS 20100422 NDA NDA022260 "Actelio
n Pharmaceuticals US, Inc." EPOPROSTENOL 1500000 ng/10mL "Prostacycline V
asodilator [EPC],Prostaglandins I [Chemical/Ingredient],Vasodilation [PE]"
66215-403_2338f36d-d36f-4f71-8584-2490394e7b03 66215-403 HUMAN PRESCRIPTI
ON DRUG Veletri epoprostenol "INJECTION, POWDER, LYOPHILIZED, FOR SOL
UTION" INTRAVENOUS 20100422 NDA NDA022260 "Actelio
n Pharmaceuticals US, Inc." EPOPROSTENOL 500000 ng/10mL "Prostacycline V
asodilator [EPC],Prostaglandins I [Chemical/Ingredient],Vasodilation [PE]"
66215-501_3f9e061a-abad-4c0a-b697-0f40315022c1 66215-501 HUMAN PRESCRIPTI
ON DRUG OPSUMIT macitentan "TABLET, FILM COATED" ORAL 20131001
NDA NDA204410 "Actelion Pharmaceuticals US, Inc." MACITENTAN
10 mg/1 "Endothelin Receptor Antagonist [EPC],Endothelin Receptor Antago
nists [MoA]"
52244-030_5201ac60-fb00-11e3-a3ac-0800200c9a66 52244-030 HUMAN PRESCRIPTI
ON DRUG Striant testosterone TABLET BUCCAL 20030619
NDA NDA021543 Actient Pharmaceuticals LLC TESTOSTERONE 30
mg/1 "Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/I
ngredient]" CIII
52244-010_e8b8ec8d-1318-43e4-a182-446e9f9579de 52244-010 HUMAN PRESCRIPTI
ON DRUG Edex alprostadil "INJECTION, POWDER, LYOPHILIZED, FOR SOL
UTION" INTRACAVERNOUS 20120415 NDA NDA020649 "Actient
Pharmaceuticals, LLC" ALPROSTADIL 10 ug/mL "Genitourinary Arterial
Vasodilation [PE],Prostaglandin Analog [EPC],Prostaglandin E1 Agonist [EPC],Pros
taglandin Receptor Agonists [MoA],Prostaglandins [Chemical/Ingredient],Venous Va
sodilation [PE]"
sodilation [PE]"
sodilation [PE]"
52244-404_d86c6a13-9e5f-43c2-92f5-c7ed7bfcedfc 52244-404 HUMAN PRESCRIPTI
ON DRUG SEMPREX D acrivastine and pseudoephedrine hydrochloride CAPSULE
ORAL 20120126 NDA NDA019806 "Actient Pharmaceuticals
, LLC" ACRIVASTINE; PSEUDOEPHEDRINE HYDROCHLORIDE 8; 60 mg/1; mg/1
"Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC],A
drenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC]"
52244-429_0db1e8dd-b4fa-491b-a529-0fb939710759 52244-429 HUMAN PRESCRIPTI
ON DRUG Robaxin Methocarbamol "TABLET, FILM COATED" ORAL 20120515
NDA NDA011011 "Actient Pharmaceuticals, LLC" METHOCARBAMOL 500
mg/1 "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]"
52244-449_0db1e8dd-b4fa-491b-a529-0fb939710759 52244-449 HUMAN PRESCRIPTI
ON DRUG Robaxin Methocarbamol "TABLET, FILM COATED" ORAL 20110818
NDA NDA011011 "Actient Pharmaceuticals, LLC" METHOCARBAMOL 750
52244-920_7ec5ba03-6164-4199-a333-7cd8d7c75e17 52244-920 HUMAN PRESCRIPTI
ON DRUG Dilatrate SR Isosorbide Dinitrate "CAPSULE, EXTENDED RELEA
SE" ORAL 20120215 NDA NDA019790 "Actient Pharmac
euticals, LLC" ISOSORBIDE DINITRATE 40 mg/1 "Nitrate Vasodilator [EP
C],Nitrates [Chemical/Ingredient],Vasodilation [PE]"
69186-001_ff2aee16-3d78-430e-a439-a16d49691664 69186-001 HUMAN OTC DRUG
Actiogen Acne Dots Treatment Acne Treatment PATCH TOPICAL 20140801
OTC MONOGRAPH FINAL part333D Actiogen Corp SALICYLIC ACID 2
mg/100mg
50421-002_0c57f630-0294-41c0-b423-a4cb1d4c3f40 50421-002 HUMAN OTC DRUG
"Camphor, Menthol" "Camphor, Menthol" GEL TOPICAL 20100113
OTC MONOGRAPH FINAL part348 Active & Innovative Inc. CAMPHOR; MENTHOL
3.4; 8.5 g/85g; g/85g
50421-004_7576e9e6-fcc8-437e-bbd4-3e6a4b2dcb73 50421-004 HUMAN OTC DRUG
"Camphor, Menthol" "Camphor, Menthol" OINTMENT TOPICAL
20100113 OTC MONOGRAPH FINAL part348 Active & Innovative Inc.
CAMPHOR; MENTHOL 4.6; 4.6 g/115g; g/115g
24488-026_5aa64081-e673-49df-b108-26b6d7c9d86c 24488-026 HUMAN OTC DRUG
MuscleCare Pain Relieving Camphor and Menthol GEL TOPICAL 20110623
OTC MONOGRAPH FINAL part341 Active and Innovative CAMPHOR (SYNTHETIC); MEN
THOL .068; .17 g/1.7g; g/1.7g
24488-026_ad3b4c32-eff7-466a-91de-4b6bf1a0e5a1 24488-026 HUMAN OTC DRUG
MuscleCare Professional Therapy Pain Relieving Camphor and Menthol
GEL TOPICAL 20110621 OTC MONOGRAPH FINAL part341 Active a
nd Innovative CAMPHOR (SYNTHETIC); MENTHOL 3.4; 8.5 g/85g; g/85g
24488-027_9f53086a-9bfe-4d9d-91da-4150504bd624 24488-027 HUMAN OTC DRUG
Professional Therapy MuscleCare Diabetic Pain Relieving OINTMENT
TOPICAL 20110602 OTC MONOGRAPH FINAL part341 Active and Innov
ative CAMPHOR (SYNTHETIC); MENTHOL 4.6; 4.6 g/115g; g/115g
24488-027_e7b642ab-f827-4165-a064-382431e74b9b 24488-027 HUMAN OTC DRUG
MuscleCare Professional Therapy Pain Relieving Menthol and Camphor
OINTMENT TOPICAL 20110621 OTC MONOGRAPH FINAL part341
Active and Innovative CAMPHOR (SYNTHETIC); MENTHOL 4.6; 4.6 g/115g;
g/115g
76029-002_9757bc14-c08d-41bb-a310-3d6c9fc11de7 76029-002 HUMAN OTC DRUG
Nerve Pain Relief Capsicum CREAM TOPICAL 20110420
UNAPPROVED HOMEOPATHIC Active Release Techniques CAPSICUM
2 [hp_C]/50g
76029-003_6b19cb05-d693-4975-abe9-25409fe02c9f 76029-003 HUMAN OTC DRUG
Wound Healing Calendula Officinalis CREAM TOPICAL 20110420
UNAPPROVED HOMEOPATHIC Active Release Techniques CALENDULA OFFICI
NALIS FLOWERING TOP 3 [hp_C]/35g
76029-001_6eb185c2-a897-4ae6-9c38-18f31e66ac60 76029-001 HUMAN OTC DRUG
Pain Relief Ruta Graveolens CREAM TOPICAL 20110401
UNAPPROVED HOMEOPATHIC Active Release Techniques LLC RUTA GRAVEOLENS
FLOWERING TOP 3 [hp_X]/50g
75989-550_9ae48262-aeb4-11e3-a5e2-0800200c9a66 75989-550 HUMAN PRESCRIPTI
ON DRUG Aerospan flunisolide "AEROSOL, METERED" RESPIRAT
ORY (INHALATION) 20120301 NDA NDA021247 "Acton P
harmaceuticals, Inc." FLUNISOLIDE 80 ug/1 "Corticosteroid [EPC],Co
48964-112_bb27c349-d154-4974-8dce-4c79ebea9659 48964-112 HUMAN OTC DRUG
nexafed pseudoephedrine HCL TABLET ORAL 20121210
OTC MONOGRAPH FINAL part341 "Acura Pharmaceuticals, Inc." PSEUDOEPHEDRINE
61619-717_63e89be2-c7f2-43bb-bfc6-58636e9cc0a8 61619-717 HUMAN OTC DRUG
Antisepation Antimicrobial Cleansing Gel Benzethonium Chloride GEL
CUTANEOUS 20140313 OTC MONOGRAPH NOT FINAL part333E
"A-Cute Derm, Incorporated" BENZETHONIUM CHLORIDE 2 mg/mL
61619-864_756f2c64-a97b-4209-ac2b-3c7119f641f8 61619-864 HUMAN OTC DRUG
Pro-Tect SPF 20 Sunscreen Broad-Spectrum UVA/UVB Sunscreen "Meradim
ate, Octinoxate, Octisalate, Oxybenzone" LOTION CUTANEOUS 19871201
OTC MONOGRAPH NOT FINAL part352 "A-Cute Derm, Incorporated" MERADIMATE; OCTI
NOXATE; OCTISALATE; OXYBENZONE 50; 75; 50; 30 mg/mL; mg/mL; mg/mL; mg/mL
61619-866_22f7ce29-6670-44dd-97ae-3bb29d7ce093 61619-866 HUMAN OTC DRUG
Pro-Tect SPF 30 Sunscreen Broad-Spectrum UVA/UVB Sunscreen "Meradim
ate, Octinoxate, Octisalate, Oxybenzone" LOTION CUTANEOUS 19801101
OTC MONOGRAPH NOT FINAL part352 "A-Cute Derm, Incorporated" MERADIMATE; OCTI
NOXATE; OCTISALATE; OXYBENZONE 50; 75; 50; 30 mg/mL; mg/mL; mg/mL; mg/mL
61098-010_c69762d1-30d5-4af4-86d8-5927192bedcc 61098-010 HUMAN OTC DRUG
REVERDIR PTD Black Diamond Mask Allantoin PATCH TOPICAL 20140601
OTC MONOGRAPH FINAL part347 "ADBIOTECH CO., LTD." ALLANTOIN 0.16
g/32g
61098-020_cb330fdb-c3a6-4669-9e20-44224dabb24d 61098-020 HUMAN OTC DRUG
REVERDIR PTD ENERGY SERUM Allantoin CREAM TOPICAL 20140601
mg/30mL
61098-030_b52e2e8b-a67a-4479-9b20-4c6a4e292499 61098-030 HUMAN OTC DRUG
REVERDIR PTD RENEW ESSENCE Allantoin CREAM TOPICAL 20140601
mg/30mL
61098-040_c19af9c6-7110-4c8d-95d6-f961c02ecfd6 61098-040 HUMAN OTC DRUG
REVERDIR PTD REACTING Dimethicone CREAM TOPICAL 20140601
OTC MONOGRAPH FINAL part347 "ADBIOTECH CO., LTD." DIMETHICONE 0.6
g/30g
64922-233_9667306e-71fc-422e-a36d-785790fe47fa 64922-233 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS "ADF Welding & Medical, Inc." OXYGEN 99
L/100L
64922-240_02da3b28-af17-4b5f-8b98-eeb0c0964be3 64922-240 HUMAN PRESCRIPTI
19900101 UNAPPROVED MEDICAL GAS "ADF Welding & Medical,
Inc." NITROGEN 99 L/100L
53964-001_059d71b4-97c9-4a3a-ac71-75c406442313 53964-001 HUMAN PRESCRIPTI
ON DRUG TEPADINA THIOTEPA "INJECTION, POWDER, FOR SOLUTION
" INTRAVENOUS 20110405 UNAPPROVED DRUG FOR USE IN DRUG
SHORTAGE ADIENNE SA THIOTEPA 15 mg/1 "Alkylat
ing Activity [MoA],Alkylating Drug [EPC]"
53964-002_76e288ae-1805-4041-9042-28167959cfe8 53964-002 HUMAN PRESCRIPTI
ON DRUG TEPADINA THIOTEPA "INJECTION, POWDER, FOR SOLUTION
" INTRAVENOUS 20110405 UNAPPROVED DRUG FOR USE IN DRUG
SHORTAGE ADIENNE SA THIOTEPA 100 mg/1 "Alkylat
ing Activity [MoA],Alkylating Drug [EPC]"
52142-001_2512f54c-1ffa-496a-961c-62495c4700f4 52142-001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS "Adirondack Compressed Gases, Inc" OXYGEN
99 L/100L
11227-010_9399aeaa-e7af-4666-9987-3f605c506d61 11227-010 HUMAN PRESCRIPTI
ON DRUG Entereg alvimopan CAPSULE ORAL 20080520 20141130
NDA NDA021775 Adolor Corporation ALVIMOPAN 12 mg/1
52096-001_e2397e82-8438-4998-9a98-812e5ee763e4 52096-001 HUMAN PRESCRIPTI
ON DRUG PerioChip Chlorhexidine Gluconate "INSERT, EXTENDED RELEAS
E" PERIODONTAL 19980501 NDA NDA020774 "Adrian
Pharmaceuticals, LLC" CHLORHEXIDINE GLUCONATE 2.5 mg/1 Decreased Cell W
all Integrity [PE]
65386-0001_f3dae8f7-d5e4-4049-9551-a8a6b8ae57ca 65386-0001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS Advacare Home Services OXYGEN 99 L/100L
60615-0001_dd248fc1-605c-4703-ac0e-0d56caa778af 60615-0001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS "Advacare Medical Services, Inc. dba Petersen Me
dical" OXYGEN 99 L/100L
63002-002_863c31cc-a3b9-4bb9-b7e9-c25c253864b2 63002-002 HUMAN OTC DRUG
Byotrol Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140502
OTC MONOGRAPH NOT FINAL part333A Advance Hygienics LLC BENZALKONIUM CHL
ORIDE 1.3 mg/mL
17714-009_655159bb-d283-4504-ad3f-562f8ba85782 17714-009 HUMAN OTC DRUG
Aspirin Aspirin "TABLET, CHEWABLE" ORAL 19880415
OTC MONOGRAPH FINAL part343 Advance Pharmaceutical Inc. ASPIRIN 81
mg/1
17714-010_8e476ecc-c829-4977-844b-c92d57dde993 17714-010 HUMAN OTC DRUG
NAL part343 Advance Pharmaceutical Inc. ASPIRIN 325 mg/1
17714-011_a4b80d52-4394-4c6a-af5d-fef3ea1ac72d 17714-011 HUMAN OTC DRUG
17714-012_1d2e4055-3526-4707-8663-85c32dfb272c 17714-012 HUMAN OTC DRUG
OTC MONOGRAPH FINAL part343 Advance Pharmaceutical Inc. ACETAMINOPHEN
325 mg/1
17714-013_de70766a-69dc-4258-81fb-0ef82c02fc8a 17714-013 HUMAN OTC DRUG
APAP Acetaminophen TABLET ORAL 19890205 OTC MONO
GRAPH FINAL part343 Advance Pharmaceutical Inc. ACETAMINOPHEN 500
mg/1
17714-014_70309c76-934b-4891-80fd-1402b95cdfb4 17714-014 HUMAN OTC DRUG
APAP Acetaminophen TABLET ORAL 19900114 OTC MONO
GRAPH FINAL part343 Advance Pharmaceutical Inc. ACETAMINOPHEN 500
mg/1
17714-016_93a742c3-ea56-4984-a1d5-890583b181b3 17714-016 HUMAN OTC DRUG
Anti Allergy Chlorpheniramine Maleate TABLET ORAL 20020109
OTC MONOGRAPH FINAL part341 Advance Pharmaceutical Inc. CHLORPHENIRAMINE
MALEATE 4 mg/1
17714-019_7bf77325-4a8a-4763-89a1-bd82f1838f8f 17714-019 HUMAN OTC DRUG
GAS RELIEF Simethicone "TABLET, CHEWABLE" ORAL 19991104
OTC MONOGRAPH FINAL part332 Advance Pharmaceutical Inc. DIMETHICONE
80 mg/1
17714-020_1dee1215-55a5-430f-a50b-02fceb4535b6 17714-020 HUMAN OTC DRUG
Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE
ORAL 19890912 OTC MONOGRAPH FINAL part341 Advance Pharmace
utical Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1
17714-021_47bb2ce7-b120-4b3f-a3ec-c575f0d5cfd3 17714-021 HUMAN OTC DRUG
17714-025_17ad8654-7d93-469a-b996-1b945e790a60 17714-025 HUMAN OTC DRUG
ANTACID Calcium Carbonate TABLET ORAL 19900406
OTC MONOGRAPH FINAL part331 Advance Pharmaceutical Inc. CALCIUM CARBONAT
E 648 mg/1
17714-041_fd016912-6560-449a-bfbc-e5e522b7ceee 17714-041 HUMAN OTC DRUG
ANTACID Calcium Carbonate "TABLET, CHEWABLE" ORAL 20071130
E 500 mg/1
17714-043_b43c92b6-7139-4efa-bd71-3c4cc35d3dd8 17714-043 HUMAN OTC DRUG
ANTACID Calcium Carbonate "TABLET, CHEWABLE" ORAL 19960126
E 500 mg/1
17714-045_c247abd4-8a28-4147-b6c3-94966eaf8d28 17714-045 HUMAN OTC DRUG
Pepto Relief Bismuth subsalicylate "TABLET, CHEWABLE" ORAL
20020109 OTC MONOGRAPH FINAL part335 Advance Pharmaceutical I
nc. BISMUTH SUBSALICYLATE 262 mg/1
17714-121_184d7697-8fe5-45b1-942d-8caa6547c6ba 17714-121 HUMAN OTC DRUG
17714-133_079fcfcb-218c-4e95-bcc1-d01d9bc1e6f0 17714-133 HUMAN OTC DRUG
ACETAMINOPHEN PM ACETAMINOPHEN PM TABLET ORAL 20020109
OTC MONOGRAPH FINAL part341 Advance Pharmaceutical Inc. ACETAMINOPHEN; D
IPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1
17714-135_de0b674c-0bd6-4037-bcd5-74de0aa5b3ad 17714-135 HUMAN OTC DRUG
Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride TABLET
45725-001_e120445c-d52a-4fd5-bf88-b75f34aad1ec 45725-001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS Advanced Apothecaries Inc. dba Health Depot
OXYGEN 99 L/100L
51345-050_d56c70a3-1bbb-499f-be87-6397fc967af7 51345-050 HUMAN OTC DRUG
Exotic Cherry Blossom Hand Sanitizer Ethyl Alcohol LIQUID TOPICAL 20110407
OTC MONOGRAPH FINAL part333E "Advanced Beauty Systems, Inc." ALCOHOL
70 mL/100mL
51345-051_278d4d09-b807-40ce-a912-4e79f043e4b3 51345-051 HUMAN OTC DRUG
Enchanted Forest Hand Sanitizer Bodycology Ethyl Alcohol LIQUID TOPICAL
20110407 OTC MONOGRAPH FINAL part333E "Advanced Beauty
Systems, Inc." ALCOHOL 22.5 mL/30mL
51345-052_4092f88b-7fb2-4db1-a0e0-cff56a4930f2 51345-052 HUMAN OTC DRUG
Fresh Cucumber Melon Bodycology Ethyl Alcohol LIQUID TOPICAL 20110407
OTC MONOGRAPH FINAL part333E "Advanced Beauty Systems, Inc." ALCOHOL
22.5 mL/30mL
51345-053_77dc19cd-d3c9-4e32-b3ea-b602dbe6c847 51345-053 HUMAN OTC DRUG
Bodycology Exotic Cherry Blossom Kit Exotic Cherry Blossom KIT
20120630 OTC MONOGRAPH NOT FINAL part333E "Advanced Beauty
Systems, Inc."
51345-055_506a9281-832b-4ff0-8d65-351b4ac68a31 51345-055 HUMAN OTC DRUG
Bodycology Enchanted Forest Kit Enchanted Forest KIT
Systems, Inc."
51345-057_81a63de1-72c5-4b34-b677-b535b14f03b6 51345-057 HUMAN OTC DRUG
Bodycology Toasted Vanilla Kit Toasted Vanilla KIT 20120630
OTC MONOGRAPH NOT FINAL part333E "Advanced Beauty Systems, Inc."
51345-059_106c1f98-de29-457b-9432-ddf5a766c645 51345-059 HUMAN OTC DRUG
Bodycology Fresh Cucumber Kit Fresh Cucumber KIT 20120630
51345-061_8626b5c7-82c0-4d38-a692-4fe1eb7189d7 51345-061 HUMAN OTC DRUG
Bodycology Enchanted Forest Kit Enchanted Forest KIT
Systems, Inc."
51345-063_dde66f79-13bf-4681-9aee-f15062101b3f 51345-063 HUMAN OTC DRUG
Bodycology Exotic Cherry Kit Exotic Cherry KIT 20120803
51345-065_e28b6e69-9d22-43e3-90aa-04d2a069d2ef 51345-065 HUMAN OTC DRUG
Bodycology Toasted Vanilla Sugar Kit Toasted Vanilla Sugar KIT
Systems, Inc."
51345-067_0d35f0e1-4acf-4493-b620-22d7e1a4276b 51345-067 HUMAN OTC DRUG
Bodycology Fresh Cucumber Melon Kit Fresh Cucumber Melon KIT
Systems, Inc."
51345-099_2cda2490-12e0-4b87-8c8e-7e7807bf5aa4 51345-099 HUMAN OTC DRUG
Epsom Salt Soaking Solution Magnesium Sulfate GRANULE TOPICAL
20120613 OTC MONOGRAPH NOT FINAL part334 "Advanced Beauty Systems
, Inc." MAGNESIUM SULFATE 2.72 kg/2.72kg
51345-105_222b38c2-2c4b-4cff-b78c-6367d1ac3e04 51345-105 HUMAN OTC DRUG
Toasted Vanilla Sugar Hand Sanitizer Bodycology Ethyl Alcohol LIQUID
TOPICAL 20110407 OTC MONOGRAPH FINAL part333E "Advance
d Beauty Systems, Inc." ALCOHOL 22.5 mL/30mL
51345-106_18987b4b-8c63-4d24-b1f7-5de17ea58614 51345-106 HUMAN OTC DRUG
Dr Teals Triple Antibiotic "Bactracin, Neomycin, Polymyxin B"
OINTMENT TOPICAL 20120806 OTC MONOGRAPH FINAL part333B
"Advanced Beauty Systems, Inc." BACITRACIN; NEOMYCIN; POLYMYXIN B 400; 3.5
; 5000 U/28g; mg/28g; U/28g
51345-107_c7f1e948-8b66-4cda-941d-0ae56f78c668 51345-107 HUMAN OTC DRUG
exotic cherry blossom kit bodycology alcohol KIT 20130624
51345-109_731cf7e3-ed44-452e-8cbd-f4f60751370a 51345-109 HUMAN OTC DRUG
Toasted Vanilla Sugar Kit Bodycology alcohol KIT 20130625
51345-111_abdaec0e-aac3-4b79-a9be-8e1efd491cc6 51345-111 HUMAN OTC DRUG
XOXO Kit bodycology alcohol KIT 20130627
51345-113_bf6f70e5-984d-4758-937d-8d9205628cae 51345-113 HUMAN OTC DRUG
Exotic Cherry Blossom Kit bodycology alcohol KIT 20130625
51345-115_8be95fb2-2780-4b7b-a95a-83dd035d0178 51345-115 HUMAN OTC DRUG
Toasted Vanilla Kit Bodycology alcohol KIT 20130625
51345-117_7639d1fa-8425-492c-8e50-ef70307b6e6d 51345-117 HUMAN OTC DRUG
XOXO Kit Bodycology alcohol KIT 20130626
51345-119_681a849f-c307-479b-bfd2-b5a9b627f357 51345-119 HUMAN OTC DRUG
Pretty in Paris Kit Bodycology alcohol KIT 20130627
51435-001_17f26cc3-8018-40e5-a80a-f33323219020 51435-001 HUMAN OTC DRUG
NEUTRACETT ULCER ALLANTOIN GLYCERIN GEL TOPICAL 20100528
OTC MONOGRAPH FINAL part347 ADVANCED BIOMEDICS INC ALLANTOIN; GLYCERIN
.5; 50 mg/.1g; mg/g
51435-002_cdf18699-0fa4-416f-ba57-a4519713ee71 51435-002 HUMAN OTC DRUG
NEUTRACETT TATTOO ALLANTOIN GLYCERIN GEL TOPICAL 20100528
.5; 50 mg/.1g; mg/g
51435-003_81cba866-6c48-4bcc-9a4b-71639db28533 51435-003 HUMAN OTC DRUG
NEUTRACETT ALL PURPOSE ALLANTOIN GLYCERIN GEL TOPICAL 20100528
.5; 50 mg/.1g; mg/g
76484-948_55480e63-4b5c-4230-905b-5edfc1f7bb18 76484-948 HUMAN OTC DRUG
20/20 Topical Anesthetic BENZOCAINE STRIP DENTAL 20120228
OTC MONOGRAPH FINAL part356 Advanced Dental Anesthetics BENZOCAINE
10 mg/1
45737-203_f94b4022-2a3a-4cf6-95af-9c2ded70ad6f 45737-203 HUMAN OTC DRUG
BIO Dtuss DMX "Brompheniramine Maleate, Dextromethorphan, Pseudoephedr
ine" LIQUID ORAL 20111201 OTC MONOGRAPH FINAL part341
Advanced Generic Corporation BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROB
ROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 1; 20; 30 mg/5mL; mg/5mL; mg/5mL
45737-205_e0a64ad6-3457-491e-ba31-c2cad4dd634e 45737-205 HUMAN OTC DRUG
BioGtuss "Dextromethorphan, Guaifenesin, Phenylephrine" LIQUID
ORAL 20091001 OTC MONOGRAPH FINAL part341 Advanced Generic
Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROC
HLORIDE 15; 300; 15 mg/5mL; mg/5mL; mg/5mL
45737-206_432ffab3-9f96-4d68-8935-a2288e92bc65 45737-206 HUMAN OTC DRUG
Bionel "Dextromethorphan, Guaifenesin, Pseudoephedrine Hydrochloride"
LIQUID ORAL 20091001 OTC MONOGRAPH FINAL part341 Advanced
Generic Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDR
INE HYDROCHLORIDE 15; 200; 30 mg/5mL; mg/5mL; mg/5mL
45737-207_76748794-8d3f-48f3-b9b6-33309ff3d3f3 45737-207 HUMAN OTC DRUG
Bionel Pediatric "Dextromethorphan, Guaifenesin, Pseudoephedrine Hydrochl
oride" LIQUID ORAL 20091001 OTC MONOGRAPH FINAL part341
Advanced Generic Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEU
DOEPHEDRINE HYDROCHLORIDE 5; 50; 15 mg/5mL; mg/5mL; mg/5mL
45737-208_db9e055a-714f-49b3-9701-e0a87c8ca09d 45737-208 HUMAN OTC DRUG
Biocotron-D "Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl"
SUSPENSION/ DROPS ORAL 20130301 OTC MONOGRAPH FINAL
part341 Advanced Generic Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENES
IN; PHENYLEPHRINE HYDROCHLORIDE 10; 200; 5 mg/5mL; mg/5mL; mg/5mL
45737-209_528a64b3-97e9-44ce-a145-45e236c22c25 45737-209 HUMAN PRESCRIPTI
ON DRUG Biocotron - "Dextromethorphan, Guaifenesin" LIQUID ORAL
20090101 OTC MONOGRAPH FINAL part341 Advanced Generic Corpora
tion DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL
"Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [E
PC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA
]"
45737-210_3bf9cec4-9e30-44d2-b0d3-373167dbaddd 45737-210 HUMAN OTC DRUG
Bionatuss DXP "Dexbrompheniramine Maleate, Dextromethorphan, Phenyleph
rine" LIQUID ORAL 20091001 OTC MONOGRAPH FINAL part341
Advanced Generic Corporation DEXBROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYD
ROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 2; 20; 10 mg/5mL; mg/5mL; mg/5mL
45737-211_50874915-9770-492e-b883-56e72c6fe1b4 45737-211 HUMAN OTC DRUG
Biospec DMX "Dextromethorphan, Guaifenesin" LIQUID ORAL 20091001
OTC MONOGRAPH FINAL part341 Advanced Generic Corporation DEXTROMETHORPHAN
HYDROBROMIDE; GUAIFENESIN 15; 25 mg/5mL; mg/5mL
45737-217_06e03308-11e6-4477-8b8e-22d9c68f43dd 45737-217 HUMAN OTC DRUG
Biobron SF "Dextromethorphan, Guaifenesin, Phenylephrine" LIQUID ORAL
tion DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
15; 350; 10 mg/5mL; mg/5mL; mg/5mL
45737-218_cf40143f-720f-4edf-ab01-6a6f22c95255 45737-218 HUMAN OTC DRUG
Bio-B Kids "Dextromethorphan,Chlorpheniramine Maleate, Phenylephrin
e" LIQUID ORAL 20091001 OTC MONOGRAPH FINAL part341
Advanced Generic Corporation CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDRO
BROMIDE; PHENYLEPHRINE HYDROCHLORIDE 4; 15; 10 mg/5mL; mg/5mL; mg/5mL
45737-221_13b19375-4fe2-40ad-8ff1-efbc6684588d 45737-221 HUMAN OTC DRUG
Biodesp DM "Dextromethorphan, Guaifenesin, Phenylephrine" LIQUID ORAL
15; 100; 5 mg/5mL; mg/5mL; mg/5mL
45737-225_a61ed81b-7422-43d6-8b84-c69810093637 45737-225 HUMAN OTC DRUG
BioTPres "Dextromethorphan, Guaifenesin, Phenylephrine" LIQUID
45737-226_f84c77b1-d231-425c-9bc7-b88424c9129c 45737-226 HUMAN OTC DRUG
Bio T Pres-B "BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE,
PHENYLEPHRINE HYDROCHLORIDE" LIQUID ORAL 20121101 OTC MONO
GRAPH FINAL part341 Advanced Generic Corporation BROMPHENIRAMINE MALEATE;
DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 4; 20; 10
45737-227_2cd2b7f9-9a3d-4b30-b4a4-99f21e7c85a4 45737-227 HUMAN OTC DRUG
BioTPres Pediatric "Dextromethorphan, Guaifenesin, Phenylephrine"
Generic Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRIN
E HYDROCHLORIDE 5; 75; 2.5 mg/5mL; mg/5mL; mg/5mL
45737-230_744a2e7b-46c7-4457-b4b3-edbca3bd62e2 45737-230 HUMAN OTC DRUG
Bio-S-Pres DX "Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl"
SOLUTION/ DROPS ORAL 20130301 OTC MONOGRAPH FINAL part341
Advanced Generic Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHEN
YLEPHRINE HYDROCHLORIDE 5; 50; 2.5 mg/mL; mg/mL; mg/mL
45737-242_a4ae9d65-88c6-4ad7-be39-e48d38128302 45737-242 HUMAN OTC DRUG
BioGtuss NF "Dextromethorphan, Guaifenesin, Phenylephrine" LIQUID
45737-246_769465ec-c7b0-46f0-ac07-a82b9f059058 45737-246 HUMAN OTC DRUG
Biobron DX "Dextromethorphan, Guaifenesin, Phenylephrine" LIQUID ORAL
20; 200; 10 mg/5mL; mg/5mL; mg/5mL
45737-249_46a2a052-0660-4cd8-a581-347eb2038b03 45737-249 HUMAN OTC DRUG
Biocof "Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine HCL"
E HYDROCHLORIDE 20; 400; 10 mg/5mL; mg/5mL; mg/5mL
45737-250_e4e3c3eb-6ea0-4d20-b99e-af7af4cfd144 45737-250 HUMAN OTC DRUG
BIO-RYTUSS "CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE
, PHENYLEPHRINE HYDROCHLORIDE" LIQUID ORAL 20120801 OTC MONO
GRAPH FINAL part341 Advanced Generic Corporation CHLORPHENIRAMINE MALEATE
; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 2; 10; 5
45737-251_58efaddb-718a-4ddf-b8aa-76ce8e5eb009 45737-251 HUMAN OTC DRUG
Bio-Z-Cough "Dextromethorphan Hydrobromide, Guaifenesin" LIQUID
Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/5mL;
mg/5mL
45737-605_678a8e9a-7480-4fbe-ad80-4907383b59c8 45737-605 HUMAN OTC DRUG
Biogtuss TR "Guaifenesin, Phenylephrine HCl, Dextromethorphan HBr"
TABLET ORAL 20140401 OTC MONOGRAPH FINAL part341 Advanced
E HYDROCHLORIDE 28; 388; 10 mg/1; mg/1; mg/1
45737-606_935db096-3fe5-44ca-b041-210d4ecfb96a 45737-606 HUMAN OTC DRUG
Biophex TR "Guaifenesin, Phenylephrine HCl" TABLET ORAL 20140401
OTC MONOGRAPH FINAL part341 Advanced Generic Corporation GUAIFENESIN; PHE
NYLEPHRINE HYDROCHLORIDE 388; 10 mg/1; mg/1
65076-0001_9643b457-b528-4dc1-bb0d-573552299660 65076-0001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS "Advanced Health Services, Inc." OXYGEN
99 L/100L
63002-001_58de352a-4b31-4fce-872c-8d5089818139 63002-001 HUMAN OTC DRUG
WSNA Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140430
OTC MONOGRAPH NOT FINAL part333A Advanced Hygienics LLC BENZALKONIUM CHL
ORIDE 1.3 mg/mL
16913-0001_125da24d-ad4f-444f-9590-fd221534d345 16913-0001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS "Advanced Medical Equipment, LLC" OXYGEN
99 L/100L
50126-001_baedd638-9374-4eed-b58d-603f2aa310af 50126-001 HUMAN OTC DRUG
Homeopathic Pediculicide Natrum Muriaticum SHAMPOO TOPICAL 20091020
UNAPPROVED HOMEOPATHIC Advanced Natural Solutions SODIUM CHLORIDE
6 [hp_X]/237mL
64889-0001_cef73f07-0583-49c9-b68c-9bcded1b216e 64889-0001 HUMAN PRESCRIPTI
ON DRUG Oxygen 64889-0001 Oxygen GAS RESPIRATORY (INHALATION)
20130325 UNAPPROVED MEDICAL GAS Advanced Oxy-Med Service
s Inc OXYGEN 99 L/100L
52205-001_2be512ee-2c1d-4860-ad8d-39f7117ee287 52205-001 HUMAN OTC DRUG
Unagel SALICYLIC ACID CREAM TOPICAL 20120904 OTC MONO
GRAPH FINAL part333D "Advanced Skin Technology, LLC" SALICYLIC ACID
2 g/100g
52205-002_d5568a8b-650c-4811-983a-2867580aab6c 52205-002 HUMAN OTC DRUG
Aqualant DIMETHICONE OIL TOPICAL 20120904
OTC MONOGRAPH FINAL part347 "Advanced Skin Technology, LLC" DIMETHICONE
24.92 mL/100mL
58790-000_7dddff3c-a1cb-4019-887c-6f484c139725 58790-000 HUMAN OTC DRUG
TheraTears Lubricant carboxymethylcellulose sodium SOLUTION/ DROPS
OPHTHALMIC 19950101 OTC MONOGRAPH FINAL part349 "Advance
d Vision Research (Subsidiary of Akorn, Inc.)" CARBOXYMETHYLCELLULOSE SODIUM
2.5 mg/mL
58790-001_60c44637-dd61-4d93-a4d9-1fd0d373c00d 58790-001 HUMAN OTC DRUG
TheraTears Lubricant carboxymethylcellulose sodium SOLUTION/ DROPS
OPHTHALMIC 19990701 OTC MONOGRAPH FINAL part349 "Advance
d Vision Research (Subsidiary of Akorn, Inc.)" CARBOXYMETHYLCELLULOSE SODIUM
2.5 mg/mL
58790-002_71cf00b4-5437-454a-a827-253383798df9 58790-002 HUMAN OTC DRUG
TheraTears carboxymethylcellulose sodium GEL OPHTHALMIC
20021201 OTC MONOGRAPH FINAL part349 "Advanced Vision Researc
h (Subsidiary of Akorn, Inc.)" CARBOXYMETHYLCELLULOSE SODIUM 10 mg/mL
58790-008_1690a8bc-16a9-49d3-a554-ce976662e36e 58790-008 HUMAN OTC DRUG
Ketotifen Fumarate Ketotifen Fumarate SOLUTION OPHTHALM
IC 20120315 ANDA ANDA077958 "Advanced Vision Researc
h (Subsidiary of Akorn, Inc.)" KETOTIFEN FUMARATE 0.35 mg/mL
58790-301_f5b013f8-7d26-4eb8-bbe8-4b5fd77c8c60 58790-301 HUMAN OTC DRUG
Allergy Eye Drops Ketotifen Fumarate SOLUTION/ DROPS OPHTHALM
IC 20131114 ANDA ANDA077958 "Advanced Vision Researc
h (Subsidiary of Akorn, Inc.)" KETOTIFEN FUMARATE 0.35 mg/mL
61579-001_1f813477-467e-4d05-a213-9db4e0227b71 61579-001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS Advantage Home Medical LLC OXYGEN 99
L/100L
68858-100_d41de66f-5264-40f0-80e1-753964e9a67b 68858-100 HUMAN OTC DRUG
MAZON MEDICATED PSORIASIS COAL TAR CREAM TOPICAL 20101101
OTC MONOGRAPH FINAL part358H Advantage Sales and Marketing COAL TAR
0.55 g/100g
68990-001_af1ae44b-daee-435f-92f3-fc332e54f383 68990-001 HUMAN OTC DRUG
SYS "Octinoxate, Titanium Dioxide" LOTION TOPICAL 20140601
OTC MONOGRAPH FINAL part352 AdvoCare International L.P. OCTINOXATE; TITA
NIUM DIOXIDE 3.75; 3 g/50mL; g/50mL
62486-130_efd2f6f7-a340-448b-8d8b-f55c91aa24f2 62486-130 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS Advocate Home Care Products OXYGEN 99
L/100L
76431-105_be9e6e65-21c7-11e4-8c21-0800200c9a66 76431-105 HUMAN PRESCRIPTI
ON DRUG Juxtapid lomitapide mesylate CAPSULE ORAL 20130103
NDA NDA203858 "Aegerion Pharmaceuticals, Inc." LOMITAPIDE MESYL
ATE 5 mg/1 "Microsomal Triglyceride Transfer Protein Inhibitor [EPC
],Microsomal Triglyceride Transfer Protein Inhibitors [MoA],Cytochrome P450 3A4
Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]"
67225-0001_f07e841e-c5bc-4c49-94ca-d34be80c1c16 67225-0001 HUMAN OTC DRUG
Dental Clinic 2080 Cavity Protection Sodium Monofluorophosphate
PASTE DENTAL 20121201 OTC MONOGRAPH FINAL part355 "Aekyung
Ind. Co., Ltd." SODIUM MONOFLUOROPHOSPHATE 0.156 g/120g
67225-0002_7ae81c2f-2d34-41af-b1d4-14e7dd554a37 67225-0002 HUMAN OTC DRUG
Dental Clinic 2080 K Strong Winter Green SODIUM FLUORIDE "PASTE,
DENTIFRICE" DENTAL 20140516 OTC MONOGRAPH FINAL part355
"Aekyung Ind. Co., Ltd." SODIUM FLUORIDE 0.1 g/100g
67225-0003_46dbc0b3-59e7-4459-8061-f4c275da7f76 67225-0003 HUMAN OTC DRUG
Dental Clinic 2080 K Citrus Cool Mint SODIUM FLUORIDE "PASTE, DENTIFRI
CE" DENTAL 20140516 OTC MONOGRAPH FINAL part355 "Aekyung
Ind. Co., Ltd." SODIUM FLUORIDE 0.1 g/100g
10014-001_d8d2063c-e912-4b94-96b3-56d4d0c3b7e2 10014-001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS Aero All Gas Company OXYGEN 990 mL/L
10014-002_932de9d0-8d69-4644-86fb-17ef377732e7 10014-002 HUMAN PRESCRIPTI
19721006 UNAPPROVED MEDICAL GAS Aero All Gas Company
NITROGEN 990 mL/L
10014-003_a1bd5a47-42d2-4975-aab9-694b5103c1f0 10014-003 HUMAN PRESCRIPTI
NITROUS OXIDE 990 mL/L
10014-004_66601a69-05b5-4f56-90ce-619bb1db507e 10014-004 HUMAN PRESCRIPTI
ON DRUG Helium Helium GAS RESPIRATORY (INHALATION) 19721006
UNAPPROVED MEDICAL GAS Aero All Gas Company HELIUM 990 mL/L
10014-005_6fac5c5c-93dc-49cf-80a8-fb06cb4bed13 10014-005 HUMAN PRESCRIPTI
CARBON DIOXIDE 990 mL/L "Radiographic Contrast Agent [EPC],X-Ray Contras
t Activity [MoA]"
10014-006_94c04484-ab76-4efe-a49b-7477cb935446 10014-006 HUMAN PRESCRIPTI
ON DRUG Oxygen Helium Mixture Oxygen Helium Mixture GAS RESPIRAT
ORY (INHALATION) 19721006 UNAPPROVED MEDICAL GAS
Aero All Gas Company HELIUM; OXYGEN 800; 200 mL/L; mL/L
10014-007_0b1b75b5-757c-4382-8811-01a71f648641 10014-007 HUMAN PRESCRIPTI
ON DRUG Oxygen Helium Mixture 40/60 Oxygen Helium Mixture 40/60
GAS RESPIRATORY (INHALATION) 19721006 UNAPPROVED MEDIC
AL GAS Aero All Gas Company HELIUM; OXYGEN 600; 400 mL/L; mL
/L
55305-111_ae5c7e38-d112-4ff3-8757-aac3dc864848 55305-111 HUMAN OTC DRUG
Instant Hand Sanitizer alcohol GEL TOPICAL 20131230
OTC MONOGRAPH NOT FINAL part333E Aero Healthcare ALCOHOL 0.665 g/mL
55305-113_b8073b11-106e-48b0-b2a8-37f01e18ba9d 55305-113 HUMAN OTC DRUG
Aeroaid Antiseptic First Aid benzocaine and benzethonium chloride
"AEROSOL, SPRAY" TOPICAL 20140820 OTC MONOGRAPH NOT FINAL
part348 "Aero Healthcare, LLC." BENZETHONIUM CHLORIDE; BENZOCAINE 76.5; 38
25 mg/85g; mg/85g
55305-114_5c18bb44-43ee-4f35-8f1a-6fde76f3dd79 55305-114 HUMAN OTC DRUG
Aerowound Blood Clotting First Aid benzethonium chloride and lidoca
ine "AEROSOL, SPRAY" TOPICAL 20140820 OTC MONOGRAPH NO
T FINAL part348 "Aero Healthcare, LLC." BENZETHONIUM CHLORIDE; LIDOCAINE
76.5; 756.5 mg/85g; mg/85g
59760-001_a285c209-f423-43b7-ae11-8854502f2c7e 59760-001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS "Aeroflow, Inc dba Aeroflow Healthcare" OXYGEN
99 L/100L
42449-120_53bdbe99-08a4-45a4-b93b-65acd895315a 42449-120 HUMAN OTC DRUG
OTC MONOGRAPH NOT FINAL part333A Aero-Med Ltd ISOPROPYL ALCOHOL
1.4 mL/1
42449-122_982db3cf-63f2-4f0f-8e34-50c3a93a30dd 42449-122 HUMAN OTC DRUG
OTC MONOGRAPH NOT FINAL part333A Aero-Med Ltd ISOPROPYL ALCOHOL
0.7 mL/mL
42449-210_5553f6f3-4b9d-4d9e-a683-713b888cc4f9 42449-210 HUMAN OTC DRUG
BZK Antiseptic Benzalkonium Chloride SWAB TOPICAL 20120202
OTC MONOGRAPH NOT FINAL part333A Aero-Med Ltd BENZALKONIUM CHLORIDE
1 g/750g
43345-002_09559804-a51c-40a6-9c06-43675309e416 43345-002 HUMAN OTC DRUG
Preferred Plus Body Powder Menthol POWDER TOPICAL 20101031
OTC MONOGRAPH NOT FINAL part348 Aetna Felt Corp MENTHOL; ZINC OXIDE .17; 1.1
g/100g; g/100g
43345-003_6443448f-36ac-46f1-b12e-c793b6b7017d 43345-003 HUMAN OTC DRUG
Aetna Callus Remover Salicylic Acid PLASTER TOPICAL 19951031
OTC MONOGRAPH FINAL part358B Aetna Felt Corp SALICYLIC ACID 0.4
1/1001
43345-004_627c1a19-6a8b-48ce-839b-1a8e8e4e9e62 43345-004 HUMAN OTC DRUG
Aetna Callus Remover Salicylic Acid PLASTER TOPICAL 19951031
OTC MONOGRAPH FINAL part358F Aetna Felt Corp SALICYLIC ACID 40
1-Jan
51532-4616_98e13f2e-28ba-4fa1-a812-43d9c85b6551 51532-4616 HUMAN OTC DRUG
CUT CLEANER "BENZALKONIUM CHLORIDE, BENZOCAINE" SWAB TOPICAL
20131201 OTC MONOGRAPH NOT FINAL part348 Afassco Inc BENZALKO
NIUM CHLORIDE; BENZOCAINE .45; 22.5 mg/.45g; mg/.45g
51532-5104_4787f361-a72a-4c92-a2ed-1200205aa81f 51532-5104 HUMAN OTC DRUG
MEDI-WIPES "ETHYL ALCOHOL, CHLOROXYLENOL" SWAB TOPICAL 20131201
OTC MONOGRAPH NOT FINAL part333E Afassco Inc ALCOHOL; CHLOROXYLENOL
.6; 7.5 g/1.5g; g/1.5g
51532-5300_1ec3eb2f-c959-4932-9d6a-51c9e718678e 51532-5300 HUMAN OTC DRUG
Antiseptic "benzalkonium chloride, benzocaine" SPRAY TOPICAL
20120709 OTC MONOGRAPH NOT FINAL part333A Afassco Inc.
BENZALKONIUM CHLORIDE; BENZOCAINE 1; 50 mg/mL; mg/mL
51532-5301_4af11d65-d82b-4275-9eb9-8f08869409af 51532-5301 HUMAN OTC DRUG
Antiseptic "benzalkonium chloride, benzocaine" LIQUID TOPICAL
20120731 OTC MONOGRAPH NOT FINAL part333A Afassco Inc.
BENZALKONIUM CHLORIDE; BENZOCAINE 1; 50 mg/mL; mg/mL
51532-5400_99b4701d-95e0-43ae-9720-98e79a68cab8 51532-5400 HUMAN OTC DRUG
OTC MONOGRAPH NOT FINAL part333A Afassco Inc. HYDROGEN PEROXIDE
30 mL/L
51532-5500_48c44dc8-210d-4b2b-94e5-42d444f219fa 51532-5500 HUMAN OTC DRUG
Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20120216
OTC MONOGRAPH NOT FINAL part333A Afassco Inc. ISOPROPYL ALCOHOL
700 mL/L
51532-6101_aada473d-23f5-4eca-8611-d1d0bf745e7a 51532-6101 HUMAN OTC DRUG
Lidocaine Hydrochloride Lidocaine Hydrochloride LIQUID TOPICAL 20120216
OTC MONOGRAPH NOT FINAL part348 Afassco Inc. LIDOCAINE HYDROCHLORIDE 200
mL/L
50102-100_37e11363-53a3-48aa-ae72-2a479813aa7e 50102-100 HUMAN PRESCRIPTI
ON DRUG LYZA norethindrone TABLET ORAL 20130624
ANDA ANDA200980 Afaxys Inc. NORETHINDRONE 0.35 mg/1 "Progest
erone Congeners [Chemical/Ingredient],Progestin [EPC]"
50102-120_77c9e72a-ce51-4317-92f9-7a58a17d2aea 50102-120 HUMAN PRESCRIPTI
ON DRUG AUBRA Levonorgestrel and Ethinyl Estradiol KIT
20131015 ANDA ANDA200245 Afaxys Inc.
50102-130_d935aa7b-2cff-42e4-bd40-e37473582452 50102-130 HUMAN PRESCRIPTI
ON DRUG Chateal Levonorgestrel and Ethinyl Estradiol KIT
20130122 ANDA ANDA091663 Afaxys Inc.
50102-911_7707de81-9aab-49fa-bb24-4df95f84eed2 50102-911 HUMAN PRESCRIPTI
ON DRUG Ella ulipristal acetate TABLET ORAL 20100813
NDA NDA022474 Afaxys Inc. ULIPRISTAL ACETATE 30 mg/1
54057-524_faeb5c8e-d956-4ad4-a4ef-6f5b5443e97f 54057-524 HUMAN OTC DRUG
ANTIMICROBIAL CLEANSER CHLOROXYLENOL SOAP TOPICAL 20131016
OTC MONOGRAPH NOT FINAL part333E "AFFLAB, Affiliated Laboratories, a Divi
sion of AFFLINK" CHLOROXYLENOL 3 g/1000mL
54057-681_1ddfa1ec-845f-4a73-aa5d-a6700991887f 54057-681 HUMAN OTC DRUG
Antimicrobial Wipes Citrus Scented BENZALKONIUM CHLORIDE CLOTH
TOPICAL 20121105 OTC MONOGRAPH NOT FINAL part333E "AFFLABS
, Affiliated Laboratories, A Division of AFFLINK" BENZALKONIUM CHLORIDE
0.01417 g/1
54057-682_772aec0b-2f01-4928-a7ed-8cdf2cfe7d92 54057-682 HUMAN OTC DRUG
Hand Sanitizer Wipes with Aloe BENZALKONIUM CHLORIDE CLOTH TOPICAL
20121105 OTC MONOGRAPH NOT FINAL part333E "AFFLABS, Affili
ated Laboratories, A Division of AFFLINK" BENZALKONIUM CHLORIDE 0.006727
5 g/1
54057-304_98e03349-1f16-477f-bc4c-7af484a1f67a 54057-304 HUMAN OTC DRUG
Alcohol Free Foam Sanitizer Benzalkonium Chloride SOAP TOPICAL
20121112 OTC MONOGRAPH NOT FINAL part333A "Afflink, Inc."
BENZALKONIUM CHLORIDE 1.3 mg/mL
54057-305_b9b5b204-7f07-4428-81d8-1c64fdb4fa42 54057-305 HUMAN OTC DRUG
Antimicrobial Foam Tricolsan SOAP TOPICAL 20121112
OTC MONOGRAPH NOT FINAL part333E "Afflink, Inc." TRICLOSAN 3
mg/mL
10572-100_907b9c8d-6c74-4a60-8f34-c6447319834a 10572-100 HUMAN PRESCRIPTI
ON DRUG PEG-3350 and Electrolytes "Polyethylene Glycol 3350, Sodiu
m Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride"
"POWDER, FOR SOLUTION" ORAL 20090701 NDA AUTHORIZED GENERIC
NDA019011 "Affordable Pharmaceuticals, LLC" POLYETHYLENE GLYCOL 3350
; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDR
OUS 236; 2.97; 6.74; 5.86; 22.74 g/4L; g/4L; g/4L; g/4L; g/4L "Osmotic
Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electro
lyte Secretion [PE],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EP
C]"
10572-101_907b9c8d-6c74-4a60-8f34-c6447319834a 10572-101 HUMAN PRESCRIPTI
ON DRUG PEG-3350 and Electrolytes "Polyethylene Glycol 3350, Sodiu
m Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride"
"POWDER, FOR SOLUTION" ORAL 20090701 NDA AUTHORIZED GENERIC
NDA019011 "Affordable Pharmaceuticals, LLC" POLYETHYLENE GLYCOL 3350
; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDR
OUS 236; 2.97; 6.74; 5.86; 22.74 g/4L; g/4L; g/4L; g/4L; g/4L "Osmotic
C]"
10572-147_453b2824-794e-4495-a260-6efff7f101c3 10572-147 HUMAN PRESCRIPTI
ON DRUG nizatidine nizatidine SOLUTION ORAL 20091218
NDA AUTHORIZED GENERIC NDA021494 "Affordable Pharmaceuticals, LLC"
NIZATIDINE 15 mg/mL "Histamine H2 Receptor Antagonists [MoA],Histami
ne-2 Receptor Antagonist [EPC]"
10572-302_dcd1e641-9925-4e25-a1f8-3c30f0839775 10572-302 HUMAN PRESCRIPTI
ON DRUG "PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride"
"polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chlori
de" "POWDER, FOR SOLUTION" ORAL 20130208 NDA AUTHORIZED G
ENERIC NDA019797 "Affordable Pharmaceuticals, LLC" POLYETHYLENE GLY
COL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE 420; 1.4
8; 5.72; 11.2 g/4L; g/4L; g/4L; g/4L "Osmotic Activity [MoA],Osmotic Laxative
[EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Potassium Co
mpounds [Chemical/Ingredient],Potassium Salt [EPC]"
10572-400_16fd321d-f891-4083-99f7-26e2e122619c 10572-400 HUMAN PRESCRIPTI
ON DRUG "PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride"
"polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chlori
de" "POWDER, FOR SOLUTION" ORAL 20130208 NDA AUTHORIZED G
ENERIC NDA019797 "Affordable Pharmaceuticals, LLC" POLYETHYLENE GLY
COL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE 420; 1.4
8; 5.72; 11.2 g/4L; g/4L; g/4L; g/4L "Osmotic Activity [MoA],Osmotic Laxative
52188-515_8cfa64c8-f34e-480a-b86a-6d04b053c881 52188-515 HUMAN OTC DRUG
Aftermath Hand Sanitizer HUSKY 515 GEL TOPICAL 20100321
OTC MONOGRAPH NOT FINAL part333 Aftermath Inc. ETHANOL 600 mL/1000mL
46324-2421_5a481188-ea06-4598-9ad5-baa75de49c46 46324-2421 HUMAN OTC DRUG
Control Anti-Dandrudff PYRITHIONE ZINC SHAMPOO TOPICAL 20111028
OTC MONOGRAPH FINAL part358H "AG Professional Hair Care Products, Ltd
" PYRITHIONE ZINC 2 mL/100mL
75885-010_cd93b0ad-b8ec-455c-a530-9735905b1d51 75885-010 HUMAN OTC DRUG
PUTTO ATO SECRET UV FACE SPF 6 ZINC OXIDE CREAM CUTANEOUS
20100401 OTC MONOGRAPH FINAL part352 AGABANG & COMPANY
TITANIUM DIOXIDE; ZINC OXIDE 1.34; 2.7 mL/80mL; mL/80mL
75885-020_2a90f358-5079-4c62-ba83-42712f2bc1b5 75885-020 HUMAN OTC DRUG
Putto Secret Sun Screen TITANIUM DIOXIDE CREAM TOPICAL 20130713
OTC MONOGRAPH FINAL part352 AGABANG & COMPANY TITANIUM DIOXIDE
6 mg/100mL
75885-030_cef50561-35f6-4582-a872-2a9fb67b5a29 75885-030 HUMAN OTC DRUG
Putto Secret UV Face TITANIUM DIOXIDE CREAM TOPICAL 20130826
2.6 mg/100mL
75885-040_08b6098d-d9e0-4a06-ad4d-f312635ca155 75885-040 HUMAN OTC DRUG
Putto Secret UV Face TITANIUM DIOXIDE CREAM TOPICAL 20130903
2.96 mg/100mL
51441-003_60276871-18b7-41a9-a041-adc91dcc5449 51441-003 HUMAN OTC DRUG
Every Day COCONUT Daily Face Broad Spectrum SPF 15 ZINC OXIDE
LOTION TOPICAL 20130424 OTC MONOGRAPH NOT FINAL part352 "Agbanga
Karite LLC, / EveryDay Shea / Alaffia Sustainable Skin Care" ZINC OXIDE
100 mg/mL
76126-007_ef4b039e-11a4-423d-81b7-54c1fff48983 76126-007 HUMAN PRESCRIPTI
ON DRUG Ceftriaxone Ceftriaxone Sodium "INJECTION, POWDER, FOR
SOLUTION" INTRAVENOUS 20130107 ANDA ANDA091068
AGILA SPECIALTIES PRIVATE LIMITED CEFTRIAXONE SODIUM 10 g/100mL
"Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]"
76126-026_31c117c6-b0d5-449b-9bb3-06b008b18a2b 76126-026 HUMAN PRESCRIPTI
ON DRUG Ampicillin Ampicillin "INJECTION, POWDER, FOR SOLUTION
" INTRAMUSCULAR; INTRAVENOUS 20140410 ANDA ANDA2010
25 AGILA SPECIALTIES PRIVATE LIMITED AMPICILLIN SODIUM 250
mg/mL "Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient]"
mg/mL "Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient]"
g/mL "Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient]"
76126-035_ded105f4-19b2-4f6e-a601-16dd87b81c68 76126-035 HUMAN PRESCRIPTI
ON DRUG Ampicillin Sodium and Sulbactam Sodium Ampicillin Sodium and Su
lbactam Sodium "INJECTION, POWDER, FOR SOLUTION" INTRAMUSCULAR; INTRAVENO
US 20140408 ANDA ANDA201024 AGILA SPECIALTIES PRIVAT
E LIMITED AMPICILLIN SODIUM; SULBACTAM SODIUM 2; 1 g/3g; g/3g
"Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lac
tamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC]"
76126-041_46607aef-bb2a-4d9f-ae4a-12815571dc36 76126-041 HUMAN PRESCRIPTI
ON DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride INJECTION
INFILTRATION; INTRAVENOUS 20140412 ANDA ANDA202242
AGILA SPECIALTIES PRIVATE LIMITED LIDOCAINE HYDROCHLORIDE 20 mg/mL
"Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],
Local Anesthesia [PE]"
" INTRAVENOUS 20140410 ANDA ANDA201025 AGILA SP
ECIALTIES PRIVATE LIMITED AMPICILLIN SODIUM 2 g/mL "Penicil
lin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient]"
76126-049_c33a167d-7e89-4dce-857f-ef141b9a80e7 76126-049 HUMAN PRESCRIPTI
lbactam Sodium "INJECTION, POWDER, FOR SOLUTION" INTRAVENOUS 20140408
ANDA ANDA202197 AGILA SPECIALTIES PRIVATE LIMITED AMPICILLIN SODIU
M; SULBACTAM SODIUM 10; 5 g/15g; g/15g "Penicillin-class Antibacterial
[EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lac
tamase Inhibitor [EPC]"
76126-050_bc7d766c-448d-4382-8eca-c34bd1684c6f 76126-050 HUMAN PRESCRIPTI
ON DRUG Ampicillin Sodium Ampicillin Sodium "INJECTION, POWD
ER, FOR SOLUTION" INTRAVENOUS 20140408 ANDA ANDA2021
g/100mL "Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient]"
76126-072_9ef3da7e-bc38-46ee-b200-b317406495ba 76126-072 HUMAN PRESCRIPTI
ON DRUG Sumatriptan Sumatriptan INJECTION SUBCUTANEOUS
20140415 ANDA ANDA203322 AGILA SPECIALTIES PRIVATE LIMITE
D SUMATRIPTAN SUCCINATE 6 mg/.5mL "Serotonin 1b Receptor Agonists
[MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Recepto
r Agonist [EPC]"
76126-075_f9dac281-857e-4566-a76e-63fba4298dcc 76126-075 HUMAN PRESCRIPTI
ON DRUG mesna mesna "INJECTION, SOLUTION" INTRAVENOUS 20140719
ANDA ANDA203364 AGILA SPECIALTIES PRIVATE LIMITED MESNA 100
mg/mL Cytoprotective Agent [EPC]
76126-100_9e6b3906-502d-4e2f-a393-8c1842e9d61e 76126-100 HUMAN PRESCRIPTI
ON DRUG oxacillin oxacillin "INJECTION, POWDER, FOR SOLUTION
86 AGILA SPECIALTIES PRIVATE LIMITED OXACILLIN SODIUM 1
g/1 "Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient]"
76126-101_9e6b3906-502d-4e2f-a393-8c1842e9d61e 76126-101 HUMAN PRESCRIPTI
ON DRUG oxacillin oxacillin "INJECTION, POWDER, FOR SOLUTION
86 AGILA SPECIALTIES PRIVATE LIMITED OXACILLIN SODIUM 2
76126-104_134ef680-fb89-4b71-b7fa-4406457c5524 76126-104 HUMAN PRESCRIPTI
ON DRUG Adenosine Adenosine "INJECTION, SOLUTION" INTRAVEN
OUS 20140322 ANDA ANDA078640 AGILA SPECIALTIES PRIVAT
E LIMITED ADENOSINE 3 mg/mL "Adenosine Receptor Agonist [EPC
],Adenosine Receptor Agonists [MoA]"
76126-202_888ad933-52a4-4d4d-91e9-bb8908ab7770 76126-202 HUMAN PRESCRIPTI
ON DRUG Ketorolac tromethamine Ketorolac tromethamine INJECTION
INTRAMUSCULAR; INTRAVENOUS 20140805 ANDA ANDA201155
AGILA SPECIALTIES PRIVATE LIMITED KETOROLAC TROMETHAMINE 15 mg/mL
"Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemi
cal/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]"
AGILA SPECIALTIES PRIVATE LIMITED KETOROLAC TROMETHAMINE 30 mg/mL
INTRAMUSCULAR 20140805 ANDA ANDA201155 AGILA SPECIALTIE
S PRIVATE LIMITED KETOROLAC TROMETHAMINE 60 mg/2mL "Cyclooxygenase
Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],
Nonsteroidal Anti-inflammatory Drug [EPC]"
76126-273_ded105f4-19b2-4f6e-a601-16dd87b81c68 76126-273 HUMAN PRESCRIPTI
lbactam Sodium "INJECTION, POWDER, FOR SOLUTION" INTRAMUSCULAR; INTRAVENO
US 20140408 ANDA ANDA201024 AGILA SPECIALTIES PRIVAT
E LIMITED AMPICILLIN SODIUM; SULBACTAM SODIUM 1; .5 g/1.5g; g/1.5g
"Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lac
tamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC]"
76126-290_e729c612-2212-48c1-b510-359e3f5e0a84 76126-290 HUMAN PRESCRIPTI
ON DRUG VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE
ANDA ANDA091469 AGILA SPECIALTIES PRIVATE LIMITED VANCOMYCIN HYDRO
CHLORIDE 10 g/100mL "Glycopeptide Antibacterial [EPC],Glycopeptides
[Chemical/Ingredient]"
58805-001_108b7ac2-082d-47d4-a07d-58c50e40bb5c 58805-001 HUMAN OTC DRUG
Diphenhydramine Hcl Diphenhydramine Hcl "CAPSULE, LIQUID FILLED"
ORAL 20131015 OTC MONOGRAPH FINAL part341 Agile Pharmachem
DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1
58805-002_9a0a8cfd-d40c-45f7-b7c8-4a4799128d9b 58805-002 HUMAN OTC DRUG
"Acetaminophen,Dextromethorphan,Phenylephrine" "Acetaminophen,Dextromet
horphan,Phenylephrine" "CAPSULE, LIQUID FILLED" ORAL 20140501
OTC MONOGRAPH FINAL part341 Agile Pharmachem ACETAMINOPHEN; DEXTROMET
HORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg
/1; mg/1
58805-003_e528f188-a1c7-4c55-803d-6dd5cae912ca 58805-003 HUMAN OTC DRUG
"Acetaminophen,Dextromethorphan,Doxylamine" "Acetaminophen,Dextromet
horphan,Doxylamine" "CAPSULE, LIQUID FILLED" ORAL 20140501
OTC MONOGRAPH FINAL part341 Agile Pharmachem ACETAMINOPHEN; DEXTROMET
HORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 10; 6.25 mg/1; mg/1; mg/1
58805-004_27b23ef9-8cde-407d-a363-0fbb3ae5a196 58805-004 HUMAN OTC DRUG
DAYTIME NIGHTTIME COLD/FLU "acetaminophen, dextromethorphan hbr, do
xylamine succinate, phenylephrine hcl" KIT ORAL 20140801
OTC MONOGRAPH FINAL part341 Agile Pharmachem
17575-001_f2660a2b-0695-40f4-bbdf-f56cc001fa56 17575-001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS AGL Inhalation Therapy Co. OXYGEN 990
mL/L
17575-004_1606ff48-5c9c-48c6-a135-9b2da806ea39 17575-004 HUMAN OTC DRUG
Carbon Dioxide Carbon Dioxide GAS RESPIRATORY (INHALATION)
19660101 UNAPPROVED MEDICAL GAS AGL Inhalation Therapy C
o. CARBON DIOXIDE 990 mL/L
17575-005_2c4b6c72-2417-4683-b97c-05d8a7b7e4a0 17575-005 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS AGL Inhalation Therapy Co. HELIUM 990
mL/L
17575-006_27d5c055-cc00-4d76-a3a8-2952e8c793e9 17575-006 HUMAN PRESCRIPTI
o. NITROGEN 990 mL/L
17575-007_39b5852e-684e-404b-9581-bb59080012a3 17575-007 HUMAN PRESCRIPTI
ON DRUG Air Air GAS RESPIRATORY (INHALATION) 19660101
UNAPPROVED MEDICAL GAS AGL Inhalation Therapy Co. AIR 1000
mL/L
17575-011_428027c8-6251-4a69-8ae7-b81502f3ac65 17575-011 HUMAN PRESCRIPTI
ON DRUG Nitrous Oxide Nitroux Oxide GAS RESPIRATORY (INHALATION)
o. NITROUS OXIDE 990 mL/L
17575-018_c8eafdb1-a31d-4cb4-b5fb-e28c8384de01 17575-018 HUMAN PRESCRIPTI
AL GAS AGL Inhalation Therapy Co. HELIUM; OXYGEN 700; 300
mL/L; mL/L
17575-020_caf1230e-2ea8-4b98-9aa6-8af50cf2d791 17575-020 HUMAN PRESCRIPTI
ON DRUG Carbon Dioxide Oxygen Mixture 5/95 Carbon Dioxide Oxygen Mi
xture 5/95 GAS RESPIRATORY (INHALATION) 19660101
UNAPPROVED MEDICAL GAS AGL Inhalation Therapy Co. CARBON DIOXIDE;
OXYGEN 50; 950 mL/L; mL/L "Radiographic Contrast Agent [EPC],X-Ray Contras
t Activity [MoA]"
17575-190_5d36b115-5548-4049-9069-a83e7de66a2a 17575-190 HUMAN PRESCRIPTI
AL GAS AGL Inhalation Therapy Co. HELIUM; OXYGEN 800; 200
mL/L; mL/L
63010-010_aae8f5e3-c52a-4cb2-b043-9130ea8294bf 63010-010 HUMAN PRESCRIPTI
ON DRUG VIRACEPT nelfinavir mesylate "TABLET, FILM COATED"
ORAL 19970314 NDA NDA020779 AGOURON NELFINAVIR MESYL
ATE 250 mg/1 "HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC]"
ON DRUG VIRACEPT nelfinavir mesylate POWDER ORAL 19970314
NDA NDA020778 AGOURON NELFINAVIR MESYLATE 50 mg/g "HIV Pro
tease Inhibitors [MoA],Protease Inhibitor [EPC]"
ON DRUG VIRACEPT nelfinavir mesylate "TABLET, FILM COATED"
ORAL 20030430 NDA NDA021503 AGOURON NELFINAVIR MESYL
ATE 625 mg/1 "HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC]"
22557-001_980d8c14-b4ae-4949-b2f7-cdeca9a7ea69 22557-001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS AGP LLC OXYGEN 99 L/100L
22557-002_d0a57b09-37d7-4c64-a358-71acedbb4938 22557-002 HUMAN PRESCRIPTI
20020101 UNAPPROVED MEDICAL GAS AGP LLC NITROGEN
99 L/100L
62870-000_5fc89013-20e4-4715-a9ba-c421243eb534 62870-000 HUMAN OTC DRUG
Agropharma Isopropyl Alcohol Isopropyl Alcohol SOLUTION
TOPICAL 20130917 OTC MONOGRAPH NOT FINAL part333A AGROPHAR
MA LABORATORIES INC ISOPROPYL ALCOHOL 70 mL/100mL
62870-041_0ea6926b-0864-40ce-b576-68b3a2313e25 62870-041 HUMAN OTC DRUG
Agropharma Isopropyl Alcohol Isopropyl Alcohol SOLUTION
TOPICAL 20130917 OTC MONOGRAPH NOT FINAL part333A AGROPHAR
MA LABORATORIES INC ISOPROPYL ALCOHOL 70 mL/100mL
60289-015_65180c92-644f-4bbc-b2cc-d790c84410f9 60289-015 HUMAN OTC DRUG
AHAVA ACTIVE DEADSEA MINERALS Mineral Suncare spf 15 OCTOCRYLENE SPRAY
TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 AHAVA - Dead Sea
Laboratories Ltd. AVOBENZONE; ENSULIZOLE; OCTISALATE; OCTOCRYLENE; TITANIU
M DIOXIDE 6.25; 2.5; 7.5; 20; 3.14 mL/250mL; mL/250mL; mL/250mL; mL
/250mL; mL/250mL
60289-030_5793e66f-b21b-45ac-ba77-43d1ddb45acf 60289-030 HUMAN OTC DRUG
AHAVA ACTIVE DEADSEA MINERALS Mineral Suncare spf 30 OCTOCRYLENE SPRAY
M DIOXIDE 7.5; 2.5; 5; 25; 3.8 mL/250mL; mL/250mL; mL/250mL; mL/250mL;
mL/250mL
60289-031_826a5dcf-25d7-4bc0-8565-d90f97805be4 60289-031 HUMAN OTC DRUG
AHAVA ACTIVE DEADSEA MINERALS Mineral Suncare spf 30 OCTOCRYLENE CREAM
M DIOXIDE 7.5; 2.5; 5; 25; 3.8 mL/250mL; mL/250mL; mL/250mL; mL/250mL;
mL/250mL
60289-050_dd4b7f02-04d9-47da-8145-b41440ca0978 60289-050 HUMAN OTC DRUG
AHAVA ACTIVE DEADSEA MINERALS Mineral Suncare spf 50 OCTOCRYLENE CREAM
M DIOXIDE 7.5; 2.5; 12.5; 25; 12.5 mL/250mL; mL/250mL; mL/250mL; mL
/250mL; mL/250mL
60289-051_450aeec9-2408-42fc-8929-05ae5825e066 60289-051 HUMAN OTC DRUG
AHAVA ACTIVE DEADSEA MINERALS Mineral Suncare spf 50 face OCTOCRYLENE
CREAM TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 AHAVA -
Dead Sea Laboratories Ltd. AVOBENZONE; ENSULIZOLE; OCTISALATE; OCTOCRYLENE;
TITANIUM DIOXIDE 1.8; .6; 3; 6; 3 mL/60mL; mL/60mL; mL/60mL; mL/60
mL; mL/60mL
60289-236_d2430dc8-4588-4f6b-825f-acc071827f01 60289-236 HUMAN OTC DRUG
AHAVA ACTIVE DEADSEA MINERALS TIME TO HYDRATE ESSENTIAL MOISTURIZING BROAD SPE
CTRUM SPF15 "Avobenzone, Octisalate, and Octocrylene" LOTION TOPICAL
20130201 OTC MONOGRAPH FINAL part352 AHAVA Dead Sea Laborator
ies Ltd AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 2.5; 1.355 g/50mL; g/50mL;
g/50mL
60289-238_cabe05ad-aba3-417c-b3fc-59fbe788f907 60289-238 HUMAN OTC DRUG
AHAVA ACTIVE DEADSEA MINERALS TIME TO HYDRATE ESSENTIAL LIP BALM BROAD SPECTRU
M SPF15 "Avobenzone, Octisalate, and Octocrylene" CREAM TOPICAL 20130808
OTC MONOGRAPH FINAL part352 AHAVA Dead Sea Laboratories Ltd AVOBENZONE; OCTI
SALATE; OCTOCRYLENE .45; .75; .411 g/15mL; g/15mL; g/15mL
60289-247_70686933-1631-4e9d-b879-85a5d49b9dd1 60289-247 HUMAN OTC DRUG
AHAVA ACTIVE DEADSEA MINERALS AGE CONTROL EVEN TONE MOISTURIZER BROAD SPECTRUM
SPF20 "Avobenzone, Octisalate, Homosalate, and Octocrylene" CREAM TOPICAL
ies Ltd AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 1.5; 2.5; 2.5; 1.35
g/50mL; g/50mL; g/50mL; g/50mL
60289-280_59891430-d832-479d-879e-2d9fb932cb7d 60289-280 HUMAN OTC DRUG
AHAVA AGE PERFECTING BROAD SPECTRUM SPF15 "Avobenzone, Octisalate, and Oct
ocrylene" CREAM TOPICAL 20131115 OTC MONOGRAPH FINAL
part352 AHAVA Dead Sea Laboratories Ltd AVOBENZONE; OCTISALATE; OCTOCRYLENE
2.25; 3.75; 2.05 g/75mL; g/75mL; g/75mL
60289-281_643d2289-d701-4710-bbc4-f39a13a92c85 60289-281 HUMAN OTC DRUG
AHAVA AGE PERFECTING BROAD SPECTRUM SPF15 "Avobenzone, Octisalate, and Oct
part352 AHAVA Dead Sea Laboratories Ltd AVOBENZONE; OCTISALATE; OCTOCRYLENE
2.25; 3.75; 2.05 g/75mL; g/75mL; g/75mL
60289-282_3185c69d-9b09-42b8-9dcc-57206a8cbc1d 60289-282 HUMAN OTC DRUG
AHAVA ACTIVE DEADSEA MINERALS TIME TO ENERGIZE AGE CONTROL MOISTURIZING BROAD
SPECTRUM SPF15 "Avobenzone, Octisalate, and Octocrylene" CREAM TOPICAL
ies Ltd AVOBENZONE; OCTISALATE; OCTOCRYLENE 30; 50; 27 mg/mL; mg/mL; mg
/mL
60000-055_f6577c5b-b4e9-4320-b949-ffe5022153ba 60000-055 HUMAN OTC DRUG
Moist Hand Wipes FRESH SCENT Benzalkonium chloride CLOTH TOPICAL
20130527 OTC MONOGRAPH NOT FINAL part333A "Ahold U.S.A., I
nc." BENZALKONIUM CHLORIDE 0.115 g/1
60000-491_be13fb92-e29c-4b0d-8b06-e546ddb6230b 60000-491 HUMAN OTC DRUG
Pure Baking Soda Baking Soda "POWDER, FOR SOLUTION" ORAL
20100601 20150115 OTC MONOGRAPH FINAL part331 "Ahold U.S.A., I
nc." SODIUM BICARBONATE 1 g/g
24909-100_0ce274aa-1514-41cc-9b08-4aadf7d1f2b5 24909-100 HUMAN OTC DRUG
Terrasil Jock-Itch Treatment MAX Clotrimazole OINTMENT TOPICAL
20140512 OTC MONOGRAPH FINAL part333C "Aidance Skincar
e & Topical Solutions, LLC" CLOTRIMAZOLE 1 g/100g
24909-102_8f9fc4aa-8a05-45fe-8fb4-8710b7a8170e 24909-102 HUMAN OTC DRUG
Terrasil Ringworm Treatment MAX Clotrimazole OINTMENT TOPICAL
24909-104_6d3d9bd5-5fe1-4f2e-8a47-46483ebaf5ec 24909-104 HUMAN OTC DRUG
Terrasil Tinea Treatment MAX Clotrimazole OINTMENT TOPICAL
24909-106_d91213e4-8254-4d58-8436-cbd1520f0965 24909-106 HUMAN OTC DRUG
Terrasil Anti-Fungal Treatment MAX Clotrimazole OINTMENT TOPICAL
24909-107_4ee266cf-f37d-4a5e-aaf3-4919fbea573c 24909-107 HUMAN OTC DRUG
TERRASIL ANTI-FUNGAL TREATMENT Clotrimazole 1.0% OINTMENT
TOPICAL 20120126 OTC MONOGRAPH FINAL part333C "Aidance
Skincare & Topical Solutions, LLC" CLOTRIMAZOLE 1 g/100g
24909-108_93c24e14-1d93-4426-ad42-53b920f3c5c3 24909-108 HUMAN OTC DRUG
Terrasil Cold Sore Treatment MAX "Allantoin, Benzalkonium Chloride"
OINTMENT TOPICAL 20120907 OTC MONOGRAPH NOT FINAL part333A
"Aidance Skincare & Topical Solutions, LLC" ALLANTOIN; BENZALKONIUM CHLORIDE
1; .13 g/100g; g/100g
24909-109_86f31e92-c25a-465d-bb5b-cf63894a6866 24909-109 HUMAN OTC DRUG
Terrasil Cold Sore Treatment "Allantoin, Benzalkonium Chloride"
OINTMENT TOPICAL 20120907 OTC MONOGRAPH NOT FINAL part333A
"Aidance Skincare & Topical Solutions, LLC" ALLANTOIN; BENZALKONIUM CHLORIDE
.5; .1 g/100g; g/100g
24909-110_70130d9a-459a-430e-b323-47ee902dcb55 24909-110 HUMAN OTC DRUG
TERRASIL COLD SORE TREATMENT MAX "Allantoin 1.0%, Lidocaine 1.0%"
OINTMENT TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part348
"Aidance Skincare & Topical Solutions, LLC" ALLANTOIN; LIDOCAINE 1; 1
g/100g; g/100g
24909-111_579aaa85-d6f2-44d0-bf13-89f33a448541 24909-111 HUMAN OTC DRUG
Terrasil Wart Removal Salicylic Acid STICK TOPICAL 20120907
OTC MONOGRAPH FINAL part358B "Aidance Skincare & Topical Solutions, L
LC" SALICYLIC ACID 12 g/100g
24909-112_6b4b4105-073b-4b85-ae7f-f8412c6b7c05 24909-112 HUMAN OTC DRUG
Terrasil Wart Removal MAX Salicylic Acid STICK TOPICAL 20120907
OTC MONOGRAPH FINAL part358B "Aidance Skincare & Topical Solutions, L
24909-113_b123b66a-a506-4ca4-8192-b0b4d1f2ce5b 24909-113 HUMAN OTC DRUG
Terrasil Wart Treatment Thuja Occidentalis OINTMENT TOPICAL
20120919 UNAPPROVED HOMEOPATHIC "Aidance Skincare & Topi
cal Solutions, LLC" THUJA OCCIDENTALIS LEAFY TWIG 6 [hp_X]/g
24909-114_5a388f0b-5e1c-4eea-8e2d-9ec8608a3d80 24909-114 HUMAN OTC DRUG
Terrasil Wart Treatment Maximum Strength Thuja Occidentalis OINTMENT
TOPICAL 20120919 UNAPPROVED HOMEOPATHIC "Aidance Skincar
e & Topical Solutions, LLC" THUJA OCCIDENTALIS LEAFY TWIG 3 [hp_X]/g
24909-115_9b99ecd7-1547-4149-8e7a-4ab4ead90228 24909-115 HUMAN OTC DRUG
TERRASIL WOUND CARE "Allantoin 0.5%, Benzethonium Chloride 0.5%"
OINTMENT TOPICAL 20120120 OTC MONOGRAPH NOT FINAL part347
"Aidance Skincare & Topical Solutions, LLC" ALLANTOIN; BENZETHONIUM CHLORIDE
.5; .5 g/100g; g/100g
24909-116_95ecbcb0-aba4-4d73-91e4-3416eb040376 24909-116 HUMAN OTC DRUG
Terrasil Wound Care MAX "Allantoin, Benzethonium Chloride" OINTMENT
TOPICAL 20120907 OTC MONOGRAPH NOT FINAL part347 "Aidance Skincar
e & Topical Solutions, LLC" ALLANTOIN; BENZETHONIUM CHLORIDE 1; .2
g/100g; g/100g
24909-117_f076c392-c3a0-4938-90a9-1f77611fff61 24909-117 HUMAN OTC DRUG
Terrasil Wound Care "Allantoin, Benzethonium Chloride" OINTMENT
e & Topical Solutions, LLC" ALLANTOIN; BENZETHONIUM CHLORIDE .5; .1
g/100g; g/100g
24909-118_3a18e0c8-29a5-4b65-a9e0-f0c265a4d78d 24909-118 HUMAN OTC DRUG
Terrasil Fissures Formula Cocoa Butter OINTMENT TOPICAL
20140610 OTC MONOGRAPH FINAL part346 "Aidance Skincare & Topi
cal Solutions, LLC" COCOA BUTTER 50 g/100g
24909-119_d5f99840-1a9e-425f-afa0-7b553d979524 24909-119 HUMAN OTC DRUG
Terrasil Balanitis Relief "Sulfur, Symphytum Officinale (Comfrey)"
OINTMENT TOPICAL 20140610 UNAPPROVED HOMEOPATHIC
"Aidance Skincare & Topical Solutions, LLC" SULFUR; SYMPHYTUM OFFICINALE WHO
LE 1; 1 [hp_X]/g; [hp_X]/g
24909-120_9737ce92-19b4-4933-8c34-ad1d0891998e 24909-120 HUMAN OTC DRUG
Terrasil Boil Pain Relief Benzocaine OINTMENT TOPICAL
20140620 OTC MONOGRAPH NOT FINAL part348 "Aidance Skincare & Topi
cal Solutions, LLC" BENZOCAINE 3.5 g/100g
24909-123_a1215ce9-feb3-4f72-956c-72f622b346c7 24909-123 HUMAN OTC DRUG
"Terrasil Itch, Rash and Pain Relief" "Allantoin, Lidocaine" OINTMENT
TOPICAL 20120907 OTC MONOGRAPH FINAL part347 "Aidance Skincar
e & Topical Solutions, LLC" ALLANTOIN; LIDOCAINE HYDROCHLORIDE .5; .5
g/100g; g/100g
24909-124_0c159510-f79a-4ef1-ac1e-33b5fe9a7d6c 24909-124 HUMAN OTC DRUG
"Terrasil Itch, Rash and Pain Relief" MAX "Allantoin, Lidocaine" OINTMENT
TOPICAL 20120907 OTC MONOGRAPH FINAL part347 "Aidance Skincar
e & Topical Solutions, LLC" ALLANTOIN; LIDOCAINE HYDROCHLORIDE 1; 1
g/100g; g/100g
24909-125_d9408f9d-0b80-43a3-8393-c20dfcf0522a 24909-125 HUMAN OTC DRUG
Terrasil Foot and Nail Anti-Fungal Clotrimazole CREAM TOPICAL
24909-126_595dc585-e5bf-4131-9bcb-70a90a1544dc 24909-126 HUMAN OTC DRUG
Terrasil Foot and Nail Anti-Fungal Maximum Strength Clotrimazole
OINTMENT TOPICAL 20140627 OTC MONOGRAPH FINAL part333C
"Aidance Skincare & Topical Solutions, LLC" CLOTRIMAZOLE 1 g/100g
24909-127_ff17bc66-f59e-43d3-b944-cbefc38b8da0 24909-127 HUMAN OTC DRUG
Terrasil Wart Removal Thuja Occidentalis OINTMENT TOPICAL
24909-131_b95d54a2-dc26-4e93-bd59-5d0dbedb0e19 24909-131 HUMAN OTC DRUG
Terrasil Skin Repair "Allantoin, Benzethonium Chloride" OINTMENT
e & Topical Solutions, LLC" ALLANTOIN; BENZETHONIUM CHLORIDE .5; .1
g/100g; g/100g
24909-132_7abb8129-10f0-488b-992e-9ccd5a32f321 24909-132 HUMAN OTC DRUG
Terrasil Skin Repair MAX "Allantoin, Benzethonium Chloride" OINTMENT
e & Topical Solutions, LLC" ALLANTOIN; BENZETHONIUM CHLORIDE 1; .2
g/100g; g/100g
24909-134_0c03bb2f-83ff-4cbd-8e8c-8524c6228092 24909-134 HUMAN OTC DRUG
Terrasil Psoriasis Therapy Maximum Strength Salicylic Acid OINTMENT
TOPICAL 20121212 OTC MONOGRAPH FINAL part358H "Aidance
Skincare & Topical Solutions, LLC" SALICYLIC ACID 3 g/100g
24909-140_9b454815-5a27-4929-ac19-0d842dce8cdd 24909-140 HUMAN OTC DRUG
Terrasil Shingles Treatment "Natrum Muriaticum, Ranunculus Bulbosus"
"Aidance Skincare & Topical Solutions, LLC" RANUNCULUS BULBOSUS; SODIUM CHLO
RIDE 10; 6 [hp_X]/g; [hp_X]/g
24909-141_d3f92867-9f0d-40b9-905b-6ecfd2a24597 24909-141 HUMAN OTC DRUG
Terrasil Shingles Treatment Maximum Strength "Natrum Muriaticum, Ranu
nculus Bulbosus" OINTMENT TOPICAL 20121011 UNAPPROV
ED HOMEOPATHIC "Aidance Skincare & Topical Solutions, LLC" RANUNCUL
US BULBOSUS; SODIUM CHLORIDE 10; 3 [hp_X]/g; [hp_X]/g
24909-142_780bd6e0-addd-47a7-8cae-009e4ea4000b 24909-142 HUMAN OTC DRUG
Terragen HG Treatment "Graphites, Natrum Muriaticum, Ranunculus Bulbos
us, Thuja Occidentalis" OINTMENT TOPICAL 20121011 UNAPPROV
ED HOMEOPATHIC "Aidance Skincare & Topical Solutions, LLC" GRAPHITE
; RANUNCULUS BULBOSUS; SODIUM CHLORIDE; THUJA OCCIDENTALIS LEAFY TWIG 10; 10;
6; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g
24909-143_7c369457-5abe-42af-bce4-061d74ab75e8 24909-143 HUMAN OTC DRUG
Terragen HG Treatment Maximum Strength "Graphites, Natrum Muriaticum, R
anunculus Bulbosus, Thuja Occidentalis" OINTMENT TOPICAL 20121011
UNAPPROVED HOMEOPATHIC "Aidance Skincare & Topical Solutions, LLC"
GRAPHITE; RANUNCULUS BULBOSUS; SODIUM CHLORIDE; THUJA OCCIDENTALIS LEAFY TWIG
10; 10; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g
24909-144_66c06d4f-12ab-4ff7-9e6b-bfc0ca0b30d1 24909-144 HUMAN OTC DRUG
Terrasil Molluscum Treatment Thuja Occidentalis OINTMENT
24909-145_20d7e5e9-8d88-483d-a7dd-b67e7f184459 24909-145 HUMAN OTC DRUG
Terrasil Molluscum Treatment Maximum Strength Thuja Occidentalis
"Aidance Skincare & Topical Solutions, LLC" THUJA OCCIDENTALIS LEAFY TWIG
3 [hp_X]/g
24909-146_30e3d891-794e-491e-abb6-2cd0195edf39 24909-146 HUMAN OTC DRUG
Terrasil IPL Relief Thuja Occidentalis OINTMENT TOPICAL
24909-147_a12e7d6a-24be-43d7-9804-b5e1b95f6edf 24909-147 HUMAN OTC DRUG
Terrasil IPL Relief Maximum Strength Thuja Occidentalis OINTMENT
24909-148_e0eccf39-59a5-4478-bd16-f453a06f3836 24909-148 HUMAN OTC DRUG
Terrasil S.O.S. Formula "Natrum Muriaticum, Ranunculus Bulbosus"
"Aidance Skincare & Topical Solutions, LLC" RANUNCULUS BULBOSUS; SODIUM CHLO
RIDE 10; 6 [hp_X]/g; [hp_X]/g
24909-149_18f25691-ef1b-446b-8683-093e9fb19bd9 24909-149 HUMAN OTC DRUG
Terrasil S.O.S. Formula Maximum Strength "Natrum Muriaticum, Ranunculus B
ulbosus" OINTMENT TOPICAL 20140513 UNAPPROVED HOMEO
PATHIC "Aidance Skincare & Topical Solutions, LLC" RANUNCULUS BULBO
SUS; SODIUM CHLORIDE 10; 3 [hp_X]/g; [hp_X]/g
24909-161_b4680e3c-d356-47db-9d8f-c2d6bbbde8e8 24909-161 HUMAN OTC DRUG
Terrasil Fast and Natural Wart Removal Thuja Occidentalis OINTMENT
24909-162_3e80a11e-1c5e-43d3-a1b6-94c163bf30d9 24909-162 HUMAN OTC DRUG
Terrasil Rapid-Relief Vaginal Miconazole Nitrate KIT
e & Topical Solutions, LLC"
24909-163_22ac774a-b61a-4d9b-85f6-3c1e835cdb51 24909-163 HUMAN OTC DRUG
"Terrasil Itch, Rash and Pain Relief" "Allantoin, Lidocaine" KIT
20140418 OTC MONOGRAPH NOT FINAL part347 "Aidance Skincare & Topi
cal Solutions, LLC"
24909-164_4a83f102-02d8-49d2-9abb-734866e13d72 24909-164 HUMAN OTC DRUG
Terrasil Rapid-Clear Psoriasis "Salicylic Acid, Thuja, Sulfur" KIT
20140418 OTC MONOGRAPH FINAL part358H "Aidance Skincar
24909-165_9a69f530-dfef-4d2b-888f-5d645c62ae18 24909-165 HUMAN OTC DRUG
Terrasil Rapid-Clear Anti-Fungal Clotrimazole KIT
24909-201_e607c872-637a-40d6-89bf-95ba0b6e18db 24909-201 HUMAN OTC DRUG
Femmesil Creme Maximum Strength Miconazole Nitrate CREAM TOPICAL
e & Topical Solutions, LLC" MICONAZOLE NITRATE 2 g/100g
24909-202_638a25cb-47b3-40a4-af76-fde15a518b4c 24909-202 HUMAN OTC DRUG
Femmesil Maximum Strength Miconazole Nitrate OINTMENT
TOPICAL 20120907 OTC MONOGRAPH FINAL part333C "Aidance
Skincare & Topical Solutions, LLC" MICONAZOLE NITRATE 2 g/100g
24909-301_c47bc18c-aa68-4df2-8eeb-c9daa67f19e6 24909-301 HUMAN OTC DRUG
Pedesil Maximum Strength Clotrimazole OINTMENT TOPICAL 20120907
OTC MONOGRAPH FINAL part333C "Aidance Skincare & Topical Solutions, L
LC" CLOTRIMAZOLE 1 g/100g
24909-303_8370f4bb-1c1a-42f1-b6a5-7b495bb614ed 24909-303 HUMAN OTC DRUG
Pedesil Clotrimazole CREAM TOPICAL 20120907 OTC MONO
GRAPH FINAL part333C "Aidance Skincare & Topical Solutions, LLC"
CLOTRIMAZOLE 1 g/100g
24909-401_57e1e412-9769-4ad9-a315-0064a0c9eedc 24909-401 HUMAN OTC DRUG
ThatZit Acne Treatment Salicylic Acid LOTION TOPICAL 20120907
OTC MONOGRAPH FINAL part333D "Aidance Skincare & Topical Solutions, L
24909-402_3fed7bb8-5af3-485d-b755-a6576379d2ab 24909-402 HUMAN OTC DRUG
ThatZit Acne Treatment MAX Salicylic Acid LOTION TOPICAL 20120907
OTC MONOGRAPH FINAL part333D "Aidance Skincare & Topical Solutions, L
24909-606_4c0f30d8-2d5d-4bde-ad2c-4aae4997f2c0 24909-606 HUMAN OTC DRUG
Aspiera Anti-Fungal Clotrimazole OINTMENT TOPICAL 20120531
OTC MONOGRAPH FINAL part333C "Aidance Skincare & Topical Solutions, L
LC" CLOTRIMAZOLE 1 g/100g
24909-617_8be668f5-9e77-475e-aacd-7a81eb2fa59b 24909-617 HUMAN OTC DRUG
Aspiera Wound Care and Antiseptic "Allantoin, Benzethonium Chlorid
e" OINTMENT TOPICAL 20120531 OTC MONOGRAPH NOT FINAL
part347 "Aidance Skincare & Topical Solutions, LLC" ALLANTOIN; BENZETHONIUM
CHLORIDE .5; .1 g/100g; g/100g
24909-618_e57a73f6-5be7-48bc-89b2-d982f5909ef6 24909-618 HUMAN OTC DRUG
Aspiera Wound Care and Antiseptic "Allantoin, Benzethonium Chlorid
e" OINTMENT TOPICAL 20120722 OTC MONOGRAPH NOT FINAL
part347 "Aidance Skincare & Topical Solutions, LLC" ALLANTOIN; BENZETHONIUM
CHLORIDE 1; .2 g/100g; g/100g
33261-001_52b8a439-688c-43db-bfea-a773b81a2157 33261-001 HUMAN PRESCRIPTI
ON DRUG Acetaminophen And Codeine acetaminophen and codeine phosph
ate TABLET ORAL 19880930 ANDA ANDA089805 Aidarex
Pharmaceuticals LLC ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg
/1 "Full Opioid Agonists [MoA],Opioid Agonist [EPC]" CIII
33261-002_52b8a439-688c-43db-bfea-a773b81a2157 33261-002 HUMAN PRESCRIPTI
ate TABLET ORAL 19880930 ANDA ANDA089828 Aidarex
Pharmaceuticals LLC ACETAMINOPHEN; CODEINE PHOSPHATE 300; 60 mg/1; mg
33261-004_93729350-108f-4474-811d-9e4ca0294eac 33261-004 HUMAN PRESCRIPTI
ANDA ANDA074174 Aidarex Pharmaceuticals LLC ALPRAZOLAM 0.5
mg/1 "Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]" CIV
ANDA ANDA074174 Aidarex Pharmaceuticals LLC ALPRAZOLAM 1
33261-007_3b66c2f6-3d9f-4bc4-bad4-c6736f1d45e7 33261-007 HUMAN PRESCRIPTI
ON DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride
Aidarex Pharmaceuticals LLC AMITRIPTYLINE HYDROCHLORIDE 25 mg/1
Tricyclic Antidepressant [EPC]
33261-010_c3489764-d9f9-4d2a-ab7f-3c3bfa652af7 33261-010 HUMAN PRESCRIPTI
ON DRUG Baclofen Baclofen TABLET ORAL 20050830
ANDA ANDA077156 Aidarex Pharmaceuticals LLC BACLOFEN 10
mg/1 "GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-erg
ic Agonist [EPC]"
33261-011_c3489764-d9f9-4d2a-ab7f-3c3bfa652af7 33261-011 HUMAN PRESCRIPTI
ANDA ANDA077068 Aidarex Pharmaceuticals LLC BACLOFEN 20
ic Agonist [EPC]"
33261-012_b5db0a4b-286e-42a7-accc-70fc84efeaa7 33261-012 HUMAN PRESCRIPTI
ATED" ORAL 20000207 ANDA ANDA075584 Aidarex Pharmace
uticals LLC BUPROPION HYDROCHLORIDE 75 mg/1 "Aminoketone [EPC],Dopam
ine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinep
hrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]"
33261-013_b5db0a4b-286e-42a7-accc-70fc84efeaa7 33261-013 HUMAN PRESCRIPTI
uticals LLC BUPROPION HYDROCHLORIDE 100 mg/1 "Aminoketone [EPC],Dopam
ine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinep
hrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]"
33261-014_33365e8c-5579-4254-aac1-04601d46cec7 33261-014 HUMAN PRESCRIPTI
ON DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL
20020228 ANDA ANDA075022 Aidarex Pharmaceuticals LLC
BUSPIRONE HYDROCHLORIDE 10 mg/1
33261-015_33365e8c-5579-4254-aac1-04601d46cec7 33261-015 HUMAN PRESCRIPTI
BUSPIRONE HYDROCHLORIDE 15 mg/1
33261-018_6b12226c-28cd-4448-9b95-242fd0cc761e 33261-018 HUMAN PRESCRIPTI
ON DRUG Cefadroxil Cefadroxil CAPSULE ORAL 20080423
ANDA ANDA065392 Aidarex Pharmaceuticals LLC CEFADROXIL 500
mg/1 "Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]"
33261-019_bcb89362-3e1a-41ed-ba17-d740662897e0 33261-019 HUMAN PRESCRIPTI
ON DRUG CELEBREX Celecoxib CAPSULE ORAL 19981002
NDA NDA020998 Aidarex Pharmaceuticals LLC CELECOXIB 200
mg/1 "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compound
33261-020_9e4f9fd2-cd74-4527-8b28-4688f72cdf6f 33261-020 HUMAN PRESCRIPTI
ON DRUG cephalexin cephalexin CAPSULE ORAL 20100621
ANDA ANDA062791 Aidarex Pharmaceuticals LLC CEPHALEXIN ANHYDROUS
500 mg/1 "Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingr
edient]"
33261-021_a9dbb759-844a-4b12-9fe5-c08c041c49b6 33261-021 HUMAN PRESCRIPTI
ON DRUG Chlorzoxazone Chlorzoxazone TABLET ORAL 20110822
ANDA ANDA089859 Aidarex Pharmaceuticals LLC CHLORZOXAZONE 500
33261-024_d122e35a-08d1-441b-8a9d-b9b99ddcab9e 33261-024 HUMAN PRESCRIPTI
ON DRUG Cimetidine Cimetidine "TABLET, FILM COATED" ORAL
CIMETIDINE 400 mg/1 "Histamine H2 Receptor Antagonists [MoA],Histami
33261-026_11d5faa0-145f-45b8-a386-b17d0ef240d0 33261-026 HUMAN PRESCRIPTI
ON DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL
CITALOPRAM HYDROBROMIDE 10 mg/1 "Serotonin Reuptake Inhibitor [EPC],Sero
tonin Uptake Inhibitors [MoA]"
33261-029_8fa29043-847f-4835-b929-70ac0e139880 33261-029 HUMAN PRESCRIPTI
ANDA ANDA077856 Aidarex Pharmaceuticals LLC CLONAZEPAM 1
33261-033_1b891b2e-c23a-44cf-8d4e-4d26dd070023 33261-033 HUMAN PRESCRIPTI
ON DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride
TABLET ORAL 20100218 ANDA ANDA078218 Aidarex Pharmace
uticals LLC CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 "Centrally-media
ted Muscle Relaxation [PE],Muscle Relaxant [EPC]"
33261-034_1288f851-da84-40fb-9b2c-d50c826fe791 33261-034 HUMAN PRESCRIPTI
ON DRUG Diazepam diazepam TABLET ORAL 20060331
ANDA ANDA077749 Aidarex Pharmaceuticals LLC DIAZEPAM 5
33261-038_86cb1755-1ee1-46a2-8db0-4c573a5dbc9f 33261-038 HUMAN PRESCRIPTI
ON DRUG Diclofenac Potassium Diclofenac Potassium "TABLET, FILM CO
uticals LLC DICLOFENAC POTASSIUM 50 mg/1 "Cyclooxygenase Inhibito
33261-039_67a1c308-26ed-4150-8e1e-21c9d07d220f 33261-039 HUMAN OTC DRUG
Non-Habit Forming Stool Softener DOCUSATE SODIUM "CAPSULE, LIQUID
FILLED" ORAL 20120329 OTC MONOGRAPH NOT FINAL part334
Aidarex Pharmaceuticals LLC DOCUSATE SODIUM 100 mg/1
33261-043_f67ac41b-c0aa-4443-8468-fc7e2f975da7 33261-043 HUMAN PRESCRIPTI
ON DRUG Etodolac Etodolac "TABLET, FILM COATED" ORAL
ETODOLAC 400 mg/1 "Cyclooxygenase Inhibitors [MoA],Nonsteroidal An
ti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory D
rug [EPC]"
33261-044_f67ac41b-c0aa-4443-8468-fc7e2f975da7 33261-044 HUMAN PRESCRIPTI
ETODOLAC 500 mg/1 "Cyclooxygenase Inhibitors [MoA],Nonsteroidal An
rug [EPC]"
33261-045_ca0dc511-15a7-4911-a012-ad975bfc34d3 33261-045 HUMAN PRESCRIPTI
ON DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL
FLUOXETINE HYDROCHLORIDE 20 mg/1 "Serotonin Reuptake Inhibitor [E
PC],Serotonin Uptake Inhibitors [MoA]"
33261-048_aeb1540b-a797-44b1-9964-28ddfba18b4f 33261-048 HUMAN PRESCRIPTI
ANDA ANDA078428 Aidarex Pharmaceuticals LLC GABAPENTIN 100
mg/1 "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganize
33261-051_0756b645-0741-4473-b777-7ee472358140 33261-051 HUMAN PRESCRIPTI
GABAPENTIN 600 mg/1 "Anti-epileptic Agent [EPC],Decreased Central Ne
rvous System Disorganized Electrical Activity [PE]"
33261-053_8ba67275-a748-4be8-8398-f76b900c2daa 33261-053 HUMAN PRESCRIPTI
ON DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bita
rtrate And Acetaminophen TABLET ORAL 20060119 ANDA
ANDA040655 Aidarex Pharmaceuticals LLC ACETAMINOPHEN; HYDROCODONE BITAR
TRATE 325; 5 mg/1; mg/1 "Opioid Agonist [EPC],Opioid Agonists [MoA]"
CIII
CIII
TRATE 325; 7.5 mg/1; mg/1 "Opioid Agonist [EPC],Opioid Agonists [M
oA]" CIII
oA]" CIII
oA]" CIII
CIII
33261-060_06f5fb33-7f65-4bc8-bbaf-be11626de267 33261-060 HUMAN OTC DRUG
Ibuprofen Ibuprofen "TABLET, FILM COATED" ORAL 19940816
ANDA ANDA072096 Aidarex Pharmaceuticals LLC IBUPROFEN 200
mg/1
33261-061_f3c660d7-4795-4f28-bc87-7a97a6b3c256 33261-061 HUMAN PRESCRIPTI
ON DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123
33261-064_db694f6b-8c95-4f66-9b6e-5ab64d416abe 33261-064 HUMAN PRESCRIPTI
ON DRUG Ketoprofen Ketoprofen CAPSULE ORAL 19930101
ANDA ANDA073517 Aidarex Pharmaceuticals LLC KETOPROFEN 75
33261-065_5a527655-75fd-42b8-b724-ff24d527a240 33261-065 HUMAN PRESCRIPTI
ON DRUG Ketorolac Tromethamine Ketorolac Tromethamine "TABLET, FILM CO
uticals LLC KETOROLAC TROMETHAMINE 10 mg/1 "Cyclooxygenase Inhibito
rs [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonstero
idal Anti-inflammatory Drug [EPC]"
33261-068_42ce3852-92b2-4637-89cf-a85b2e106ccf 33261-068 HUMAN PRESCRIPTI
ANDA ANDA078203 Aidarex Pharmaceuticals LLC LORAZEPAM 1
mg/1 "Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]"
ANDA ANDA078203 Aidarex Pharmaceuticals LLC LORAZEPAM 2
33261-070_c077af4d-7cae-43da-8004-768284bda2dd 33261-070 HUMAN PRESCRIPTI
ON DRUG meloxicam meloxicam TABLET ORAL 20070307
ANDA ANDA077927 Aidarex Pharmaceuticals LLC MELOXICAM 7.5
33261-071_c077af4d-7cae-43da-8004-768284bda2dd 33261-071 HUMAN PRESCRIPTI
ON DRUG meloxicam meloxicam TABLET ORAL 20070307
ANDA ANDA077927 Aidarex Pharmaceuticals LLC MELOXICAM 15
33261-072_db596a36-5f82-4d41-a563-e583eb355e56 33261-072 HUMAN PRESCRIPTI
ON DRUG Methocarbamol Methocarbamol TABLET ORAL 20000101
ANDA ANDA085159 Aidarex Pharmaceuticals LLC METHOCARBAMOL 750
33261-073_c25beec4-de6c-4516-a172-f7408248831a 33261-073 HUMAN PRESCRIPTI
MIRTAZAPINE 15 mg/1
33261-074_96a2c79d-af3b-44d6-8894-7483dc3e2139 33261-074 HUMAN PRESCRIPTI
MIRTAZAPINE 30 mg/1
33261-076_384c955d-a727-43b5-be9e-3e6f501cf2d3 33261-076 HUMAN PRESCRIPTI
ON DRUG Misoprostol Misoprostol TABLET ORAL 20120725
ANDA ANDA091667 Aidarex Pharmaceuticals LLC MISOPROSTOL 200
ug/1 "Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ing
redient]"
33261-077_856e729d-1c5e-40d8-96e6-90b1e3cf43c9 33261-077 HUMAN PRESCRIPTI
ON DRUG Nabumetone Nabumetone "TABLET, FILM COATED" ORAL
NABUMETONE 500 mg/1 "Cyclooxygenase Inhibitors [MoA],Nonsteroidal An
rug [EPC]"
33261-078_b3102c1a-a63f-480c-9391-99669c295f7f 33261-078 HUMAN PRESCRIPTI
rug [EPC]"
33261-079_8ec413d7-65e0-4019-a2bc-7b8ebb2e7824 33261-079 HUMAN OTC DRUG
good sense all day pain relief Naproxen Sodium TABLET ORAL 19970114
ANDA ANDA074661 Aidarex Pharmaceuticals LLC NAPROXEN SODIUM 220
mg/1
33261-080_7e3dcdf1-4ba5-458d-b4e1-20ab4e9dda2b 33261-080 HUMAN PRESCRIPTI
ON DRUG Naproxen Naproxen TABLET ORAL 20100218
ANDA ANDA075927 Aidarex Pharmaceuticals LLC NAPROXEN 375
33261-081_4ac8c61d-66f2-49f0-959f-7f2a92137a61 33261-081 HUMAN PRESCRIPTI
33261-082_c4e5a877-72fc-4cd7-9492-905e8df337d8 33261-082 HUMAN PRESCRIPTI
ON DRUG Naproxen Naproxen "TABLET, DELAYED RELEASE"
ORAL 19980731 ANDA ANDA075227 Aidarex Pharmaceuticals
LLC NAPROXEN 375 mg/1 "Cyclooxygenase Inhibitors [MoA],Nonster
oidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflam
matory Drug [EPC]"
33261-083_c4e5a877-72fc-4cd7-9492-905e8df337d8 33261-083 HUMAN PRESCRIPTI
ON DRUG Naproxen Naproxen "TABLET, DELAYED RELEASE"
LLC NAPROXEN 500 mg/1 "Cyclooxygenase Inhibitors [MoA],Nonster
matory Drug [EPC]"
33261-084_f67ff8f9-fff1-4cd4-abc6-819b577837dc 33261-084 HUMAN PRESCRIPTI
ON DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20070426
33261-085_f67ff8f9-fff1-4cd4-abc6-819b577837dc 33261-085 HUMAN PRESCRIPTI
33261-087_884283f6-ff17-45e2-8452-731609251271 33261-087 HUMAN PRESCRIPTI
ON DRUG Omeprazole Omeprazole "CAPSULE, DELAYED RELEASE"
LLC OMEPRAZOLE 20 mg/1 "Proton Pump Inhibitor [EPC],Proton Pump
Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]"
33261-088_2076f538-fb8b-4bbb-aaff-c50a32e92d07 33261-088 HUMAN PRESCRIPTI
ON DRUG Orphenadrine Citrate Orphenadrine Citrate "TABLET, EXTENDE
D RELEASE" ORAL 19980619 ANDA ANDA040284 Aidarex
Pharmaceuticals LLC ORPHENADRINE CITRATE 100 mg/1 "Centrally-media
33261-090_847c3a3f-7716-462c-a7f3-481e3501876b 33261-090 HUMAN PRESCRIPTI
ON DRUG Paroxetine Paroxetine "TABLET, FILM COATED" ORAL
PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 "Serotonin Reuptake Inhi
bitor [EPC],Serotonin Uptake Inhibitors [MoA]"
33261-091_847c3a3f-7716-462c-a7f3-481e3501876b 33261-091 HUMAN PRESCRIPTI
PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 "Serotonin Reuptake Inhi
33261-099_aa25a817-e7ed-4ec7-9a59-235d9277ff84 33261-099 HUMAN PRESCRIPTI
ON DRUG Ranitidine Ranitidine TABLET ORAL 20091216
ANDA ANDA077824 Aidarex Pharmaceuticals LLC RANITIDINE HYDROCHLORIDE
150 mg/1 "Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor An
tagonist [EPC]"
33261-100_3aa87574-73f6-487c-9e06-6f5b348b38dc 33261-100 HUMAN PRESCRIPTI
ON DRUG Sulindac Sulindac TABLET ORAL 20100125
ANDA ANDA072711 Aidarex Pharmaceuticals LLC SULINDAC 200
33261-103_9b79e6bb-62f1-473c-ac30-3dba1a23384d 33261-103 HUMAN PRESCRIPTI
ON DRUG Tizanidine Tizanidine TABLET ORAL 20020703
ANDA ANDA076286 Aidarex Pharmaceuticals LLC TIZANIDINE HYDROCHLORIDE
nist [EPC]"
33261-104_9b79e6bb-62f1-473c-ac30-3dba1a23384d 33261-104 HUMAN PRESCRIPTI
ANDA ANDA076286 Aidarex Pharmaceuticals LLC TIZANIDINE HYDROCHLORIDE
nist [EPC]"
33261-105_a1b50aab-a35e-46cf-9966-4e9237deea6c 33261-105 HUMAN PRESCRIPTI
ON DRUG Tramadol Hydrochloride Tramadol Hydrochloride "TABLET, COATED"
LLC TRAMADOL HYDROCHLORIDE 50 mg/1 "Full Opioid Agonists [MoA],Opio
id Agonist [EPC]"
33261-106_e1c475c2-3437-4249-af16-1f9142ff1941 33261-106 HUMAN PRESCRIPTI
ON DRUG Topiramate Topiramate "TABLET, FILM COATED" ORAL
TOPIRAMATE 25 mg/1 "Anti-epileptic Agent [EPC],Decreased Central Ne
33261-107_ed1631ee-9ac0-4936-9749-e6be6ef1aa44 33261-107 HUMAN PRESCRIPTI
ON DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL
TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC]
33261-109_0a6cb56c-0b44-45d8-8538-ca16e678ab9b 33261-109 HUMAN PRESCRIPTI
ON DRUG Lisinopril Lisinopril TABLET ORAL 20060113
ANDA ANDA077321 Aidarex Pharmaceuticals LLC LISINOPRIL 40
mg/1 "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting En
zyme Inhibitors [MoA]"
33261-110_e65cb52f-902e-46f2-bf7c-05aa73ef281e 33261-110 HUMAN PRESCRIPTI
33261-111_6c362672-6199-4377-a903-2eb110e836fb 33261-111 HUMAN PRESCRIPTI
ON DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulan
ate Potassium "TABLET, FILM COATED" ORAL 20021031 ANDA
ANDA065096 Aidarex Pharmaceuticals LLC AMOXICILLIN; CLAVULANATE POTASSI
UM 875; 125 mg/1; mg/1 "Penicillin-class Antibacterial [EPC],Pe
nicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase In
hibitors [MoA]"
33261-112_6c362672-6199-4377-a903-2eb110e836fb 33261-112 HUMAN PRESCRIPTI
ANDA065101 Aidarex Pharmaceuticals LLC AMOXICILLIN; CLAVULANATE POTASSI
hibitors [MoA]"
33261-116_0756b645-0741-4473-b777-7ee472358140 33261-116 HUMAN PRESCRIPTI
33261-117_884283f6-ff17-45e2-8452-731609251271 33261-117 HUMAN PRESCRIPTI
33261-128_4ac8c61d-66f2-49f0-959f-7f2a92137a61 33261-128 HUMAN PRESCRIPTI
33261-129_3c78a73d-80ef-4a71-8aeb-a101196947e6 33261-129 HUMAN PRESCRIPTI
ON DRUG Prednisone Prednisone TABLET ORAL 20030212
ANDA ANDA040392 Aidarex Pharmaceuticals LLC PREDNISONE 20
mg/1
33261-130_db596a36-5f82-4d41-a563-e583eb355e56 33261-130 HUMAN PRESCRIPTI
ANDA ANDA085159 Aidarex Pharmaceuticals LLC METHOCARBAMOL 500
33261-131_d3cfec5b-8dfb-4138-8ee0-09bf49a5c38e 33261-131 HUMAN PRESCRIPTI
ON DRUG Promethazine Hydrochloride Promethazine Hydrochloride
uticals LLC PROMETHAZINE HYDROCHLORIDE 25 mg/1 "Phenothiazine [
EPC],Phenothiazines [Chemical/Ingredient]" CIV
33261-132_145b4e74-3442-4d9c-81b7-f71fe7401332 33261-132 HUMAN PRESCRIPTI
ON DRUG Phenazopyridine Hydrochloride Phenazopyridine TABLET ORAL
20110201 UNAPPROVED DRUG OTHER Aidarex Pharmaceuticals
LLC PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1
33261-134_65666c2b-4095-4d95-b941-e5ef4956474c 33261-134 HUMAN PRESCRIPTI
ON DRUG Penicillin V Potassium Penicillin V Potassium TABLET ORAL
PENICILLIN V POTASSIUM 250 mg/1
33261-137_d4fa5d57-edb5-4dc5-94a0-5cd9bddc9dcd 33261-137 HUMAN PRESCRIPTI
ON DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20050911
ANDA ANDA065271 Aidarex Pharmaceuticals LLC AMOXICILLIN 500
mg/1 "Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient]"
33261-138_65666c2b-4095-4d95-b941-e5ef4956474c 33261-138 HUMAN PRESCRIPTI
ON DRUG Penicillin V Potassium Penicillin V Potassium TABLET ORAL
PENICILLIN V POTASSIUM 500 mg/1
33261-141_b6201f98-9bd5-4cde-87b6-750478ff74ae 33261-141 HUMAN PRESCRIPTI
ON DRUG PROCHLORPERAZINE MALEATE Prochlorperazine Maleate
uticals LLC PROCHLORPERAZINE MALEATE 5 mg/1 "Phenothiazine [
EPC],Phenothiazines [Chemical/Ingredient]"
33261-142_1af6f684-9c87-4b46-bb20-cce0769174bf 33261-142 HUMAN OTC DRUG
Mapap ACETAMINOPHEN TABLET ORAL 20110421 OTC MONO
GRAPH FINAL part343 Aidarex Pharmaceuticals LLC ACETAMINOPHEN 325
mg/1
33261-143_d2bb7fc7-fb5c-4aee-b764-58cbe04933db 33261-143 HUMAN PRESCRIPTI
ON DRUG Doxycycline Doxycycline hyclate "TABLET, COATED"
LLC DOXYCYCLINE HYCLATE 100 mg/1
33261-144_d4fa5d57-edb5-4dc5-94a0-5cd9bddc9dcd 33261-144 HUMAN PRESCRIPTI
ANDA ANDA065271 Aidarex Pharmaceuticals LLC AMOXICILLIN 250
33261-145_01865cdb-07be-4125-8bd9-6e4c61f5f0f8 33261-145 HUMAN PRESCRIPTI
ON DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL
METFORMIN HYDROCHLORIDE 1000 mg/1 "Biguanide [EPC],Biguanides [Chemical/In
gredient]"
33261-146_08efe152-6ce2-477a-9b41-0b3fe7abb8eb 33261-146 HUMAN PRESCRIPTI
ON DRUG Gemfibrozil Gemfibrozil "TABLET, FILM COATED" ORAL
GEMFIBROZIL 600 mg/1 "Peroxisome Proliferator Receptor alpha Agonist
[EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha
33261-147_5e2ff1d2-363a-41a0-b6ac-8ced16c6fb7b 33261-147 HUMAN PRESCRIPTI
ON DRUG benzonatate benzonatate CAPSULE ORAL 20070725
ANDA ANDA040627 Aidarex Pharmaceuticals LLC BENZONATATE 100
mg/1 "Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic
Antitussive [EPC]"
33261-148_927a9937-2723-496c-ad8d-5b4ddcad446c 33261-148 HUMAN PRESCRIPTI
ON DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Tri
methoprim TABLET ORAL 20100913 ANDA ANDA076899
Aidarex Pharmaceuticals LLC SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160
mg/1; mg/1 "Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredie
nt],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antib
acterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhi
bitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]"
33261-149_9e4f9fd2-cd74-4527-8b28-4688f72cdf6f 33261-149 HUMAN PRESCRIPTI
ON DRUG cephalexin cephalexin CAPSULE ORAL 20100621
ANDA ANDA062791 Aidarex Pharmaceuticals LLC CEPHALEXIN ANHYDROUS
250 mg/1 "Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingr
edient]"
33261-150_145b4e74-3442-4d9c-81b7-f71fe7401332 33261-150 HUMAN PRESCRIPTI
33261-151_72aa6c88-0bac-469c-a1d8-4433c4f926b2 33261-151 HUMAN PRESCRIPTI
ON DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL
DOXYCYCLINE HYCLATE 100 mg/1
33261-152_896b0412-3ac7-470f-b96c-b3a6b50cf6a1 33261-152 HUMAN OTC DRUG
Adult Low Dose Aspirin Aspirin "TABLET, DELAYED RELEASE" ORAL
20070112 OTC MONOGRAPH FINAL part343 Aidarex Pharmaceuticals
LLC ASPIRIN 81 mg/1
33261-153_0d38a94d-5641-4615-96ee-28363bda0515 33261-153 HUMAN OTC DRUG
Regular Strength Aspirin EC Aspirin "TABLET, DELAYED RELEASE"
ORAL 20110909 OTC MONOGRAPH FINAL part343 Aidarex Pharmace
uticals LLC ASPIRIN 325 mg/1
33261-157_14425971-c3fa-42df-b5bc-f2406863729b 33261-157 HUMAN PRESCRIPTI
gredient]"
33261-158_be013517-42af-4118-8ae1-b35b8ea34684 33261-158 HUMAN PRESCRIPTI
HYDROCHLOROTHIAZIDE 25 mg/1 "Increased Diuresis [PE],Thiazide Diuret
ic [EPC],Thiazides [Chemical/Ingredient]"
33261-159_8eb8b8e7-e935-4074-8a7a-d1e9116fd6f6 33261-159 HUMAN PRESCRIPTI
ON DRUG Clindamycin hydrochloride Clindamycin hydrochloride
CAPSULE ORAL 20010323 ANDA ANDA065061 Aidarex Pharmace
uticals LLC CLINDAMYCIN HYDROCHLORIDE 150 mg/1 "Decreased Sebac
eous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/
Ingredient]"
33261-160_287b7aba-b3e7-4a98-ac8b-474f17157b0e 33261-160 HUMAN PRESCRIPTI
ON DRUG Nitrofurantoin Monohydrate/ Macrocrystalline Nitrofurantoin M
onohydrate/Macrocrystalline CAPSULE ORAL 20110525 NDA
NDA020064 Aidarex Pharmaceuticals LLC NITROFURANTOIN; NITROFURANTOIN M
ONOHYDRATE 25; 75 mg/1; mg/1 "Nitrofuran Antibacterial [EPC],Nitrofur
ans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/I
ngredient]"
33261-163_265be229-6d0b-4ceb-a94a-7f84ca2c3141 33261-163 HUMAN PRESCRIPTI
uticals LLC DICYCLOMINE HYDROCHLORIDE 20 mg/1 "Anticholinergic
[EPC],Cholinergic Antagonists [MoA]"
33261-164_da202d5d-414e-42a2-8a90-e20c90b0afec 33261-164 HUMAN PRESCRIPTI
ON DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20040910
ANDA ANDA076639 Aidarex Pharmaceuticals LLC CIPROFLOXACIN HYDROCHLOR
IDE 500 mg/1 "Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingr
edient]"
33261-166_9f5ed975-8bb7-4b71-af13-292cbd830a24 33261-166 HUMAN PRESCRIPTI
ANDA ANDA070184 Aidarex Pharmaceuticals LLC METOCLOPRAMIDE HYDROCHLO
RIDE 10 mg/1 "Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antag
onist [EPC]"
33261-170_2e6b8fbe-b434-4564-9587-c81e3a758345 33261-170 HUMAN PRESCRIPTI
ON DRUG Sertraline Hydrochloride Sertraline Hydrochloride
uticals LLC SERTRALINE HYDROCHLORIDE 50 mg/1 "Serotonin Reupt
ake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]"
33261-171_2e6b8fbe-b434-4564-9587-c81e3a758345 33261-171 HUMAN PRESCRIPTI
uticals LLC SERTRALINE HYDROCHLORIDE 25 mg/1 "Serotonin Reupt
33261-172_a1bad093-8e73-403e-a4b7-f7fede4451d9 33261-172 HUMAN PRESCRIPTI
ON DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL
ZOLPIDEM TARTRATE 5 mg/1 "gamma-Aminobutyric Acid-ergic Agonist [
EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous Syste
m Depression [PE]" CIV
33261-173_a1bad093-8e73-403e-a4b7-f7fede4451d9 33261-173 HUMAN PRESCRIPTI
ON DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL
33261-174_8e5a1b85-9468-4dc3-94b8-06cda657d5b3 33261-174 HUMAN PRESCRIPTI
ON DRUG Furosemide Furosemide TABLET ORAL 20090129
ANDA ANDA078010 Aidarex Pharmaceuticals LLC FUROSEMIDE 20
mg/1 "Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC]"
33261-178_78f88be7-cf2a-457c-b2ab-3a9144283384 33261-178 HUMAN OTC DRUG
Enteric Coated Stimulant Laxative Bisacodyl "TABLET, DELAYED
RELEASE" ORAL 20110922 OTC MONOGRAPH NOT FINAL part334
Aidarex Pharmaceuticals LLC BISACODYL 5 mg/1
33261-179_2e92a75c-ab99-49b1-8033-efbbcace2d68 33261-179 HUMAN PRESCRIPTI
ON DRUG Benazepril Hydrochloride Benazepril Hydrochloride
uticals LLC BENAZEPRIL HYDROCHLORIDE 10 mg/1 "Angiotensin Con
verting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],De
creased Blood Pressure [PE]"
33261-182_b01ba900-3657-4093-875f-11c5140561a3 33261-182 HUMAN PRESCRIPTI
ON DRUG CAPTOPRIL CAPTORPIL TABLET ORAL 19970328
ANDA ANDA074532 Aidarex Pharmaceuticals LLC CAPTOPRIL 50
33261-183_8b3d55d1-6227-4214-8b25-fa39a072fcc7 33261-183 HUMAN PRESCRIPTI
ON DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride "TABLET, FILM CO
uticals LLC DILTIAZEM HYDROCHLORIDE 60 mg/1 "Calcium Channel Antagon
33261-184_aa7a0856-d32b-4ddb-a71f-79cf29c9811e 33261-184 HUMAN PRESCRIPTI
ON DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20020129
ANDA ANDA076001 Aidarex Pharmaceuticals LLC FLUOXETINE HYDROCHLORIDE
10 mg/1 "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors
[MoA]"
33261-185_3a7c6910-e16c-4c50-8028-4f58aca0010b 33261-185 HUMAN PRESCRIPTI
ON DRUG Famotidine Famotidine TABLET ORAL 20010416
ANDA ANDA075805 Aidarex Pharmaceuticals LLC FAMOTIDINE 20
mg/1 "Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist
[EPC]"
33261-202_aa25a817-e7ed-4ec7-9a59-235d9277ff84 33261-202 HUMAN PRESCRIPTI
ANDA ANDA077824 Aidarex Pharmaceuticals LLC RANITIDINE HYDROCHLORIDE
tagonist [EPC]"
33261-209_fea6f761-235f-4d3d-99c6-6389070ec7d9 33261-209 HUMAN PRESCRIPTI
ON DRUG Glyburide Glyburide TABLET ORAL 20101005
ANDA ANDA090937 Aidarex Pharmaceuticals LLC GLYBURIDE 5
mg/1 "Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient]"
33261-211_ce7c1472-b399-493e-a419-e71701b04acc 33261-211 HUMAN PRESCRIPTI
ON DRUG Terazosin Terazosin CAPSULE ORAL 20010412
ANDA ANDA075498 Aidarex Pharmaceuticals LLC TERAZOSIN HYDROCHLORIDE
1 mg/1 "Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EP
C]"
C]"
33261-215_2db171f2-8e66-4b37-a0d4-ce781a9f87f7 33261-215 HUMAN PRESCRIPTI
ON DRUG Potassium Chloride Potassium Chloride "TABLET, FILM CO
ATED, EXTENDED RELEASE" ORAL 19860417 NDA NDA019123
Aidarex Pharmaceuticals LLC POTASSIUM CHLORIDE 750 mg/1 "Potassi
um Compounds [Chemical/Ingredient],Potassium Salt [EPC]"
CIII
33261-220_e821edd9-cd2c-4f50-92a2-ab13a5823e86 33261-220 HUMAN PRESCRIPTI
ON DRUG Atenolol Atenolol TABLET ORAL 20071204
ANDA ANDA077877 Aidarex Pharmaceuticals LLC ATENOLOL 25
mg/1 "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]"
33261-222_41a6f20f-8d1b-4f11-9618-d6b70ef073d9 33261-222 HUMAN OTC DRUG
Allergy Chlorpheniramine Maleate TABLET ORAL 19921219
OTC MONOGRAPH FINAL part341 Aidarex Pharmaceuticals LLC CHLORPHENIRAMINE
MALEATE 4 mg/1
33261-224_99e2903e-bc3a-4829-ac6b-f78731ee704f 33261-224 HUMAN OTC DRUG
Mi-Acid Gas Relief Simethicone "TABLET, CHEWABLE" ORAL
LLC DIMETHICONE 80 mg/1
33261-226_9d53dbae-d850-4c5b-b602-365135ceb487 33261-226 HUMAN PRESCRIPTI
ON DRUG Nitrofurantion Macrocrystals Nitrofurantion Macrocrystals
CAPSULE ORAL 20100927 NDA NDA016620 Aidarex Pharmace
uticals LLC NITROFURANTOIN 100 mg/1 "Nitrofuran Antibacterial [EPC],
Nitrofurans [Chemical/Ingredient]"
33261-227_7a30fb41-2a84-4afb-a155-46dba2cfb76a 33261-227 HUMAN PRESCRIPTI
ON DRUG Acyclovir Acyclovir TABLET ORAL 19970430
ANDA ANDA074556 Aidarex Pharmaceuticals LLC ACYCLOVIR 800
mg/1 "DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog
33261-228_733d75a7-5111-47b2-a8c2-879fca5993c6 33261-228 HUMAN OTC DRUG
fexofenadine hydrochloride fexofenadine hydrochloride "TABLET,
FILM COATED" ORAL 20110422 ANDA ANDA076447 Aidarex
Pharmaceuticals LLC FEXOFENADINE HYDROCHLORIDE 180 mg/1
33261-229_47349194-fbe8-4176-86f2-67454764c301 33261-229 HUMAN PRESCRIPTI
ON DRUG Fluconazole Fluconazole TABLET ORAL 20040729
ANDA ANDA076077 Aidarex Pharmaceuticals LLC FLUCONAZOLE 200
mg/1 "Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C1
9 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhi
bitors [MoA]"
33261-335_09135c69-fdaa-4452-a8d4-81cff1a36ceb 33261-335 HUMAN PRESCRIPTI
ON DRUG Methylprednisolone Methylprednisolone TABLET ORAL
METHYLPREDNISOLONE 4 mg/1 "Corticosteroid [EPC],Corticosteroid Hor
33261-336_dc4501f9-c70f-46c1-811b-d72fdc4af22c 33261-336 HUMAN PRESCRIPTI
uticals LLC PROPRANOLOL HYDROCHLORIDE 10 mg/1 "Adrenergic beta
-Antagonists [MoA],beta-Adrenergic Blocker [EPC]"
33261-337_44cce19f-c8c1-4ec3-bc37-7d90521f0d99 33261-337 HUMAN PRESCRIPTI
ON DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL
20020301 NDA NDA021342 Aidarex Pharmaceuticals LLC
LEVOTHYROXINE SODIUM 125 ug/1 "l-Thyroxine [EPC],Thyroxine [Chemical/I
ngredient]"
ANDA ANDA077856 Aidarex Pharmaceuticals LLC CLONAZEPAM 0.5
33261-341_2ab0e38c-de77-4f37-a0c5-c99aac1aac78 33261-341 HUMAN PRESCRIPTI
ON DRUG Phendimetrazine Tartrate Phendimetrazine Tartrate
uticals LLC PHENDIMETRAZINE TARTRATE 35 mg/1 "Appetite Suppre
EPC]" CIII
33261-342_3f4d9011-13a0-4ec4-a343-75ff90e9782f 33261-342 HUMAN PRESCRIPTI
ON DRUG Oxybutynin Chloride oxybutynin chloride TABLET ORAL
OXYBUTYNIN CHLORIDE 5 mg/1 "Cholinergic Muscarinic Antagonist [EPC]
,Cholinergic Muscarinic Antagonists [MoA]"
33261-344_c11a6272-a3e1-4962-83ca-17bdb3e966c5 33261-344 HUMAN PRESCRIPTI
ON DRUG Loperamide Hydrochloride Loperamide Hydrochloride
uticals LLC LOPERAMIDE HYDROCHLORIDE 2 mg/1 "Opioid Agonist
[EPC],Opioid Agonists [MoA]"
33261-346_c6cd640f-0dd1-4c1c-bd96-6d1aa77a0c63 33261-346 HUMAN PRESCRIPTI
ON DRUG Sertraline Sertraline "TABLET, FILM COATED" ORAL
SERTRALINE HYDROCHLORIDE 100 mg/1 "Serotonin Reuptake Inhibitor [E
33261-348_7f8fad0a-267b-4284-9de3-14ddd77d9ac0 33261-348 HUMAN PRESCRIPTI
ON DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride
uticals LLC NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antide
pressant [EPC]
mg/1
mg/1
33261-353_9af69fd4-964e-4666-88da-0bc5697e11c1 33261-353 HUMAN PRESCRIPTI
ON DRUG DIETHYLPROPION HYDROCHLORIDE DIETHYLPROPION HYDROCHLORIDE
uticals LLC DIETHYLPROPION HYDROCHLORIDE 25 mg/1 "Appetite Suppre
EPC]" CIV
33261-354_55fa3e3c-536a-4fba-8006-86f392a23ce7 33261-354 HUMAN PRESCRIPTI
ON DRUG Diethylpropion HydrochlorideER ER Diethylpropion Hydrochloride
80 Aidarex Pharmaceuticals LLC DIETHYLPROPION HYDROCHLORIDE 75
mg/1 "Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathom
imetic Amine Anorectic [EPC]" CIV
33261-355_fffb5cb3-6568-4027-80b4-8bd01a4769ce 33261-355 HUMAN PRESCRIPTI
ON DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715
ANDA ANDA040301 Aidarex Pharmaceuticals LLC WARFARIN SODIUM 1
mg/1 "Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA]"
33261-361_5f577a31-f2d5-4439-88be-f3cac906776c 33261-361 HUMAN PRESCRIPTI
ON DRUG Phentermine Hydrochloride Phentermine Hydrochloride
uticals LLC PHENTERMINE HYDROCHLORIDE 15 mg/1 "Appetite Suppre
EPC]" CIV
ANDA ANDA078203 Aidarex Pharmaceuticals LLC LORAZEPAM 0.5
33261-366_5f577a31-f2d5-4439-88be-f3cac906776c 33261-366 HUMAN PRESCRIPTI
uticals LLC PHENTERMINE HYDROCHLORIDE 30 mg/1 "Appetite Suppre
EPC]" CIV
edient]"
33261-372_7051a1a4-226c-4a41-b5d3-0f666740855b 33261-372 HUMAN PRESCRIPTI
ON DRUG Metformin Hydrochloride Metformin Hydrochloride "TABLET, EXTENDE
Pharmaceuticals LLC METFORMIN HYDROCHLORIDE 500 mg/1 "Biguanide [EPC]
,Biguanides [Chemical/Ingredient]"
33261-373_2cddca79-12fd-478f-a173-9f43803be9e1 33261-373 HUMAN PRESCRIPTI
ON DRUG lisinopril lisinopril TABLET ORAL 20020701
33261-374_8e5a1b85-9468-4dc3-94b8-06cda657d5b3 33261-374 HUMAN PRESCRIPTI
ANDA ANDA078010 Aidarex Pharmaceuticals LLC FUROSEMIDE 40
33261-376_2c5e9aab-f400-47be-ab36-e1b3f055f249 33261-376 HUMAN PRESCRIPTI
ON DRUG Potassium Chloride Potassium Chloride "TABLET, EXTENDE
Pharmaceuticals LLC POTASSIUM CHLORIDE 20 meq/1 "Potassium Compo
unds [Chemical/Ingredient],Potassium Salt [EPC]"
33261-378_880fc0c0-c656-4e55-80da-b4db6eff4467 33261-378 HUMAN PRESCRIPTI
ON DRUG HYDROCODONE BITARTRATE AND IBUPROFEN HYDROCODONE BITARTRATE A
ND IBUPROFEN "TABLET, FILM COATED" ORAL 20040401 ANDA
ANDA076604 Aidarex Pharmaceuticals LLC HYDROCODONE BITARTRATE; IBUPROFE
N 7.5; 200 mg/1; mg/1 "Opioid Agonist [EPC],Opioid Agonists [M
oA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Ch
emical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]" CIII
oA]" CIII
33261-384_351fe213-7c9c-4d7e-a68e-3d6b84c663ca 33261-384 HUMAN PRESCRIPTI
ON DRUG Metronidazole Metronidazole TABLET ORAL 20110822
ANDA ANDA070044 Aidarex Pharmaceuticals LLC METRONIDAZOLE 500
mg/1 "Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient
]"
33261-387_8b551ae6-9f3a-4ff2-b62d-e74d5e6fe9a0 33261-387 HUMAN PRESCRIPTI
ON DRUG Carisoprodol Carisoprodol TABLET ORAL 20100830
ANDA ANDA040124 Aidarex Pharmaceuticals LLC CARISOPRODOL 350
CIV
33261-389_048674b0-b55d-481c-9aaf-680782983177 33261-389 HUMAN PRESCRIPTI
ON DRUG Tramadol Hydrochloride and Acetaminophen Tramadol Hydroch
loride and Acetaminophen TABLET ORAL 20091217 ANDA
ANDA090485 Aidarex Pharmaceuticals LLC ACETAMINOPHEN; TRAMADOL HYDROCHL
ORIDE 325; 37.5 mg/1; mg/1 "Full Opioid Agonists [MoA],Opioid Agoni
st [EPC]"
33261-390_a815119a-0cf9-4dfd-9c17-aa9af6e52585 33261-390 HUMAN PRESCRIPTI
"CAPSULE, EXTENDED RELEASE" ORAL 19770906 NDA NDA01807
4 Aidarex Pharmaceuticals LLC PHENDIMETRAZINE TARTRATE 105
imetic Amine Anorectic [EPC]" CIII
33261-391_bbb202cc-8929-4ad4-bb03-3737038a6e4e 33261-391 HUMAN PRESCRIPTI
ON DRUG Promethazine with Codeine Promethazine Hydrochloride and C
odeine Phosphate SYRUP ORAL 20060131 ANDA ANDA0406
50 Aidarex Pharmaceuticals LLC CODEINE PHOSPHATE; PROMETHAZINE HYDROCHL
ORIDE 10; 6.25 mg/5mL; mg/5mL "Phenothiazine [EPC],Phenothiazines [Che
mical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC]" CV
33261-393_18da72cf-bc71-46c3-a184-f99740bf8d7d 33261-393 HUMAN OTC DRUG
Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET
LLC CETIRIZINE HYDROCHLORIDE 10 mg/1
33261-396_a3ab3a35-a130-4804-9ad8-0d733c7a8d48 33261-396 HUMAN PRESCRIPTI
Aidarex Pharmaceuticals LLC SULFAMETHOXAZOLE; TRIMETHOPRIM 400; 80 mg/1; mg
/1 "Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cyto
chrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial
[EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [
MoA],Organic Cation Transporter 2 Inhibitors [MoA]"
33261-397_c5e4b51a-8b09-4030-8221-7de9183d4110 33261-397 HUMAN PRESCRIPTI
ON DRUG Glipizide Glipizide TABLET ORAL 20020925
ANDA ANDA075795 Aidarex Pharmaceuticals LLC GLIPIZIDE 5
edient]"
33261-400_bb2afcb1-4412-4841-a449-7feff8f10da0 33261-400 HUMAN PRESCRIPTI
ON DRUG Topiramate Topiramate TABLET ORAL 20110101
ANDA ANDA079162 Aidarex Pharmaceuticals LLC TOPIRAMATE 50
33261-403_335dec43-2c8b-4432-81e1-f9284a7a834f 33261-403 HUMAN PRESCRIPTI
ON DRUG AZITHROMYCIN AZITHROMYCIN "TABLET, FILM COATED" ORAL
AZITHROMYCIN ANHYDROUS 250 mg/1 "Macrolide Antimicrobial [EPC],Macrolide
33261-408_de1b0250-3018-48a3-a7f3-49639679a086 33261-408 HUMAN PRESCRIPTI
uticals LLC PHENTERMINE HYDROCHLORIDE 37.5 mg/1 "Appetite Suppre
EPC]" CIV
33261-413_433935fb-4377-4c68-9fd8-b127bf281095 33261-413 HUMAN OTC DRUG
Meclizine HCl Meclizine HCl TABLET ORAL 20080722
OTC MONOGRAPH FINAL part336 Aidarex Pharmaceuticals LLC MECLIZINE HYDROC
HLORIDE 25 mg/1
33261-415_a981e42c-0e19-4340-bf9e-eb489d691fe7 33261-415 HUMAN PRESCRIPTI
ON DRUG Antipyrine and Benzocaine Antipyrine and Benzocaine
OTHER Aidarex Pharmaceuticals LLC ANTIPYRINE; BENZOCAINE 54; 14
mg/mL; mg/mL "Standardized Chemical Allergen [EPC],Increased Histamine Releas
e [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient]"
33261-416_76932243-b0df-474c-aa58-b41c89d051d7 33261-416 HUMAN PRESCRIPTI
ON DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLO
ROTHIAZIDE TABLET ORAL 20060410 ANDA ANDA077912
Aidarex Pharmaceuticals LLC HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20
mg/1; mg/1 "Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chem
ical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-conve
rting Enzyme Inhibitors [MoA]"
33261-417_1156d9cb-4ad2-49c0-b7ee-4b947c5dcc84 33261-417 HUMAN PRESCRIPTI
ON DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride
Aidarex Pharmaceuticals LLC ONDANSETRON HYDROCHLORIDE 4 mg/1
"Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]"
ON DRUG Acyclovir Acyclovir CAPSULE ORAL 19970423
33261-433_c5e4b51a-8b09-4030-8221-7de9183d4110 33261-433 HUMAN PRESCRIPTI
ANDA ANDA075795 Aidarex Pharmaceuticals LLC GLIPIZIDE 10
33261-434_b467b2f6-9ecd-45be-a714-664764233d01 33261-434 HUMAN PRESCRIPTI
ON DRUG Minocycline hydrochloride Minocycline hydrochloride
uticals LLC MINOCYCLINE HYDROCHLORIDE 100 mg/1 "Tetracycline-cl
ass Drug [EPC],Tetracyclines [Chemical/Ingredient]"
33261-437_0d247451-52f8-45ba-a1ec-91401605c8d0 33261-437 HUMAN PRESCRIPTI
ON DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL
AMLODIPINE BESYLATE 5 mg/1 "Calcium Channel Antagonists [MoA],Dihyd
ropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient]"
33261-441_69e110c7-961b-433f-ab96-cd1c4c739c78 33261-441 HUMAN PRESCRIPTI
33261-448_8eb8b8e7-e935-4074-8a7a-d1e9116fd6f6 33261-448 HUMAN PRESCRIPTI
uticals LLC CLINDAMYCIN HYDROCHLORIDE 300 mg/1 "Decreased Sebac
Ingredient]"
33261-449_06831b0d-ae6e-45d0-bd17-955ab16c31d3 33261-449 HUMAN PRESCRIPTI
ON DRUG Bupropion Hydrochloride SR (SR) Bupropion Hydrochloride "TABLET,
FILM COATED, EXTENDED RELEASE" ORAL 20120515 ANDA ANDA2013
31 Aidarex Pharmaceuticals LLC BUPROPION HYDROCHLORIDE 150 mg/1
"Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity
[PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [Mo
A]"
33261-454_102c0c6c-be48-40e6-8299-031e8f3dc843 33261-454 HUMAN PRESCRIPTI
ON DRUG zaleplon zaleplon CAPSULE ORAL 20090505
ANDA ANDA078989 Aidarex Pharmaceuticals LLC ZALEPLON 10
mg/1 "gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],
Central Nervous System Depression [PE]" CIV
33261-458_9f37c87d-020c-4e5c-b3b9-dfae7d38ae62 33261-458 HUMAN PRESCRIPTI
ON DRUG BENZPHETAMINE HYDROCHLORIDE benzphetamine hydrochloride
uticals LLC BENZPHETAMINE HYDROCHLORIDE 50 mg/1 "Appetite Suppre
EPC]" CIII
33261-460_02811f2f-f4d1-44c0-9ba3-f8dcba5c3cf3 33261-460 HUMAN PRESCRIPTI
ON DRUG Amoxicillin Amoxicillin "POWDER, FOR SUSPENSION"
LLC AMOXICILLIN 250 mg/5mL "Penicillin-class Antibacterial [EPC],Pe
nicillins [Chemical/Ingredient]"
33261-463_12a87643-479a-4a6c-b307-646c58aa89f6 33261-463 HUMAN PRESCRIPTI
33261-464_7ba622bc-fa2c-4ed8-a06d-c545253f39f5 33261-464 HUMAN PRESCRIPTI
ate Potassium "POWDER, FOR SUSPENSION" ORAL 20111220
ANDA ANDA201090 Aidarex Pharmaceuticals LLC AMOXICILLIN; CLAVULANATE
POTASSIUM 400; 57 mg/5mL; mg/5mL "Penicillin-class Antibacterial [EPC],Pe
hibitors [MoA]"
33261-470_86859de8-6f89-477b-8e5a-c9634bb99693 33261-470 HUMAN PRESCRIPTI
ON DRUG Acetaminophen and Codeine Phosphate ACETAMINOPHEN and CODEIN
E PHOSPHATE SOLUTION ORAL 19810821 ANDA ANDA0875
08 Aidarex Pharmaceuticals LLC ACETAMINOPHEN; CODEINE PHOSPHATE
120; 12 mg/5mL; mg/5mL "Full Opioid Agonists [MoA],Opioid Agonist [EPC]"
CV
33261-471_de1b0250-3018-48a3-a7f3-49639679a086 33261-471 HUMAN PRESCRIPTI
uticals LLC PHENTERMINE HYDROCHLORIDE 37.5 mg/1 "Appetite Suppre
EPC]" CIV
33261-475_168364de-3c99-4692-8485-c0a196d3ce18 33261-475 HUMAN PRESCRIPTI
ON DRUG Prednisolone Prednisolone SOLUTION ORAL 19981211
ANDA ANDA089081 Aidarex Pharmaceuticals LLC PREDNISOLONE 15
mg/5mL "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]"
33261-480_bb2afcb1-4412-4841-a449-7feff8f10da0 33261-480 HUMAN PRESCRIPTI
ANDA ANDA079162 Aidarex Pharmaceuticals LLC TOPIRAMATE 100
33261-483_5e9ad922-f27b-413e-9b11-a1a649e4c695 33261-483 HUMAN PRESCRIPTI
ON DRUG tramadol hydrochloride tramadol hydrochloride TABLET ORAL
st [EPC]"
33261-484_8f650da9-045b-49b9-936b-c0861a2b9505 33261-484 HUMAN PRESCRIPTI
OTHER Aidarex Pharmaceuticals LLC ANTIPYRINE; BENZOCAINE 54; 14
33261-485_9caae802-6283-4387-95dd-82aa5542a22d 33261-485 HUMAN PRESCRIPTI
ON DRUG cephalexin Cephalexin FOR SUSPENSION ORAL 20060111
ANDA ANDA065234 Aidarex Pharmaceuticals LLC CEPHALEXIN 250
mg/5mL "Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]"
33261-486_102c0c6c-be48-40e6-8299-031e8f3dc843 33261-486 HUMAN PRESCRIPTI
ON DRUG zaleplon zaleplon CAPSULE ORAL 20090505
ANDA ANDA078989 Aidarex Pharmaceuticals LLC ZALEPLON 5
33261-487_d623665e-8c16-4726-a5ea-69427c124f03 33261-487 HUMAN PRESCRIPTI
ANDA ANDA077253 Aidarex Pharmaceuticals LLC FLUCONAZOLE 150
bitors [MoA]"
33261-488_9abd651c-3fc9-4426-9392-6e2a783d3d8e 33261-488 HUMAN PRESCRIPTI
ON DRUG Amoxicillin Amoxicillin "TABLET, FILM COATED" ORAL
AMOXICILLIN 875 mg/1 "Penicillin-class Antibacterial [EPC],Penicillin
33261-495_f0ecf791-3c3e-4d4d-8ab8-57d2afc63f0a 33261-495 HUMAN PRESCRIPTI
ON DRUG CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET ORAL
CLONIDINE HYDROCHLORIDE 0.1 mg/1 "Adrenergic alpha2-Agonists [MoA],Centra
l alpha-2 Adrenergic Agonist [EPC]"
ANDA ANDA074174 Aidarex Pharmaceuticals LLC ALPRAZOLAM 2
33261-520_60ad2cb3-c0b0-4bc6-be97-bc62cb405d1e 33261-520 HUMAN PRESCRIPTI
ANDA ANDA088799 Aidarex Pharmaceuticals LLC HYDROCORTISONE 25
33261-532_fed33441-965f-40ad-af22-e32244a884cd 33261-532 HUMAN PRESCRIPTI
pressant [EPC]
33261-534_625f2552-b7bf-4ee3-a58e-9e22578f2280 33261-534 HUMAN PRESCRIPTI
ON DRUG Medroxyprogesterone Acetate Medroxyprogesterone Acetate
uticals LLC MEDROXYPROGESTERONE ACETATE 10 mg/1 "Progesterone Co
ngeners [Chemical/Ingredient],Progestin [EPC]"
33261-537_381aa246-233f-490b-80cb-91fef3b7bf56 33261-537 HUMAN PRESCRIPTI
ON DRUG Carvedilol Carvedilol "TABLET, FILM COATED" ORAL
CARVEDILOL 25 mg/1 "Adrenergic alpha-Antagonists [MoA],Adrenergic b
eta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Block
er [EPC],beta-Adrenergic Blocker [EPC]"
33261-541_733c33c5-9968-4f49-9f73-2aab91932134 33261-541 HUMAN PRESCRIPTI
33261-545_1615bea2-4bef-460c-9bde-65b19531f000 33261-545 HUMAN PRESCRIPTI
ON DRUG Metoprolol Tartrate metoprolol tartrate "TABLET, FILM CO
uticals LLC METOPROLOL TARTRATE 100 mg/1 "Adrenergic beta-Antagon
ists [MoA],beta-Adrenergic Blocker [EPC]"
33261-547_397bf662-ca3a-44ce-a21f-745cf71e15de 33261-547 HUMAN PRESCRIPTI
ANDA ANDA075991 Aidarex Pharmaceuticals LLC LOVASTATIN 10
mg/1 "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase I
nhibitors [MoA]"
nhibitors [MoA]"
nhibitors [MoA]"
33261-550_b6201f98-9bd5-4cde-87b6-750478ff74ae 33261-550 HUMAN PRESCRIPTI
ON DRUG PROCHLORPERAZINE MALEATE Prochlorperazine maleate
uticals LLC PROCHLORPERAZINE MALEATE 10 mg/1 "Phenothiazine [
33261-554_533f028c-bba8-491b-9860-bd45f27d352b 33261-554 HUMAN PRESCRIPTI
ON DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL
ALENDRONATE SODIUM 70 mg/1 "Bisphosphonate [EPC],Diphosphonates [Ch
emical/Ingredient]"
33261-562_316b2807-6d53-4d3d-9346-064bccd2fd60 33261-562 HUMAN PRESCRIPTI
ON DRUG Famotidine Famotidine "TABLET, FILM COATED" ORAL
FAMOTIDINE 40 mg/1 "Histamine H2 Receptor Antagonists [MoA],Histami
33261-564_3ad10c0b-4d0f-44dd-a9ca-9ed8289d52ef 33261-564 HUMAN PRESCRIPTI
ON DRUG Lidocaine Lidocaine OINTMENT TOPICAL 19720630
ANDA ANDA080198 Aidarex Pharmaceuticals LLC LIDOCAINE 50
mg/g "Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmi
c [EPC],Local Anesthesia [PE]"
33261-591_23d5e33c-26ef-43a2-a88f-5b601eeb126d 33261-591 HUMAN PRESCRIPTI
ON DRUG Lidocaine and Prilocaine Lidocaine and Prilocaine
CREAM TOPICAL 20030925 ANDA ANDA076290 Aidarex Pharmace
uticals LLC LIDOCAINE; PRILOCAINE 25; 25 mg/g; mg/g "Amide Local Ane
sthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia
[PE],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia
[PE]"
ANDA ANDA074174 Aidarex Pharmaceuticals LLC ALPRAZOLAM 0.25
33261-597_294053a9-959b-49d5-a4e7-f0e4e2061e4e 33261-597 HUMAN PRESCRIPTI
ON DRUG Allopurinol Allopurinol TABLET ORAL 20090406
NDA NDA018877 Aidarex Pharmaceuticals LLC ALLOPURINOL 300
mg/1 "Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA]"
33261-600_7f5fefc0-1979-45a2-966c-616ca2ccfa7f 33261-600 HUMAN PRESCRIPTI
ON DRUG Amoxicillin and Clavulanate Potassium amoxicillin and clavulan
ate potassium "POWDER, FOR SUSPENSION" ORAL 20010622
NDA NDA050755 Aidarex Pharmaceuticals LLC AMOXICILLIN; CLAVULANATE
POTASSIUM 600; 42.9 mg/5mL; mg/5mL "Penicillin-class Antibacterial
[EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lact
amase Inhibitors [MoA]"
33261-602_1135c0be-16b1-4427-aaa6-bd81d53ed2fb 33261-602 HUMAN PRESCRIPTI
33261-604_2323a0e0-63f8-4083-bda3-2f65f374fd40 33261-604 HUMAN PRESCRIPTI
ON DRUG GENTAMICIN SULFATE gentamicin sulfate SOLUTION/ DROPS
OPHTHALMIC 19980105 ANDA ANDA062452 Aidarex Pharmace
uticals LLC GENTAMICIN SULFATE 3 mg/mL "Aminoglycoside Antibact
erial [EPC],Aminoglycosides [Chemical/Ingredient]"
uticals LLC MEDROXYPROGESTERONE ACETATE 2.5 mg/1 "Progesterone Co
33261-618_c32a755e-ce62-4ae6-a581-e1f2f26e65ed 33261-618 HUMAN PRESCRIPTI
ON DRUG Clarithromycin Clarithromycin "TABLET, FILM COATED" ORAL
CLARITHROMYCIN 500 mg/1 "Macrolide Antimicrobial [EPC],Macrolides [Chemi
cal/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibito
rs [MoA],P-Glycoprotein Inhibitors [MoA]"
33261-621_38af301a-ce6f-4d9e-b36a-a20cd38b8618 33261-621 HUMAN PRESCRIPTI
ON DRUG Divalproex SodiumDelayed-Release Delayed-Release Divalproex Sodiu
m "TABLET, FILM COATED" ORAL 20091130 ANDA ANDA0902
10 Aidarex Pharmaceuticals LLC DIVALPROEX SODIUM 500 mg/1
ical Activity [PE],Mood Stabilizer [EPC]"
33261-623_1db86484-b07f-4b68-85f0-547d7e723183 33261-623 HUMAN PRESCRIPTI
ON DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL
33261-625_cb55bd60-89dd-4231-a2da-2694ed2973fb 33261-625 HUMAN PRESCRIPTI
ON DRUG Dexamethasone dexamethasone TABLET ORAL 19830428
ANDA ANDA088238 Aidarex Pharmaceuticals LLC DEXAMETHASONE 4
mg/1 "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]"
33261-627_9e647b64-0405-4e32-97bd-0edb09854911 33261-627 HUMAN PRESCRIPTI
ON DRUG BUPROPION HYDROCHLORIDE bupropion hydrochloride "TABLET, FILM CO
Aidarex Pharmaceuticals LLC BUPROPION HYDROCHLORIDE 300 mg/1 "Aminoke
ANDA ANDA077856 Aidarex Pharmaceuticals LLC CLONAZEPAM 2
33261-631_c32a755e-ce62-4ae6-a581-e1f2f26e65ed 33261-631 HUMAN PRESCRIPTI
33261-634_5e2ff1d2-363a-41a0-b6ac-8ced16c6fb7b 33261-634 HUMAN PRESCRIPTI
ANDA ANDA040749 Aidarex Pharmaceuticals LLC BENZONATATE 200
Antitussive [EPC]"
33261-641_c587a83e-6bd2-4645-8044-0884fbb2bc4f 33261-641 HUMAN PRESCRIPTI
ON DRUG Divalproex Sodium Divalproex Sodium "TABLET, DELAYED
RELEASE" ORAL 20080729 ANDA ANDA078597 Aidarex
Pharmaceuticals LLC DIVALPROEX SODIUM 250 mg/1 "Anti-epileptic
Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [P
E],Mood Stabilizer [EPC]"
33261-644_1e7747a9-6c6e-4026-8be6-5963db67ed61 33261-644 HUMAN PRESCRIPTI
LEVETIRACETAM 250 mg/1 "Anti-epileptic Agent [EPC],Decreased Central Ne
33261-647_d62710fe-d3d0-4714-b3bb-e1f6dd916946 33261-647 HUMAN PRESCRIPTI
ON DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127
ANDA ANDA079132 Aidarex Pharmaceuticals LLC LAMOTRIGINE 25
d Electrical Activity [PE],Mood Stabilizer [EPC]"
33261-648_3ccfd582-29b5-4ea0-8f3b-2bd4fca4ace0 33261-648 HUMAN PRESCRIPTI
33261-651_d2826e15-72bb-4bba-9f87-d2661147caca 33261-651 HUMAN OTC DRUG
SudoGest Pseudoephedrine Hydrochloride "TABLET, FILM COATED"
ORAL 19941001 OTC MONOGRAPH FINAL part341 Aidarex Pharmace
uticals LLC PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg/1 CI
33261-658_8828c164-2572-4b0e-8228-d86a9ca630d0 33261-658 HUMAN PRESCRIPTI
ON DRUG Doxazosin doxazosin mesylate TABLET ORAL 20111027
ANDA ANDA075509 Aidarex Pharmaceuticals LLC DOXAZOSIN MESYLATE
C]"
33261-665_8fa5d478-4b57-48f2-80ef-746f8f8953b6 33261-665 HUMAN OTC DRUG
Arthritis Pain Reliever Acetaminophen "TABLET, FILM COATED, EXTENDED R
ELEASE" ORAL 20020430 ANDA ANDA076200 Aidarex Pharmace
uticals LLC ACETAMINOPHEN 650 mg/1
33261-667_81b5ab1e-b277-43ac-9a7b-d14d60457c12 33261-667 HUMAN PRESCRIPTI
ON DRUG Estradiol Estradiol TABLET ORAL 19971028
ANDA ANDA040197 Aidarex Pharmaceuticals LLC ESTRADIOL 1
mg/1 "Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Recep
tor Agonists [MoA]"
33261-672_b6c1e040-459d-4640-b493-c18c2d96faea 33261-672 HUMAN PRESCRIPTI
ON DRUG LIDODERM lidocaine PATCH CUTANEOUS 19990320
NDA NDA020612 Aidarex Pharmaceuticals LLC LIDOCAINE 700
mg/1 "Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmi
33261-674_39a3e584-a805-427d-8f53-44c2ad215b2f 33261-674 HUMAN PRESCRIPTI
ON DRUG Lansoprazole lansoprazole "CAPSULE, DELAYED RELEASE"
LLC LANSOPRAZOLE 30 mg/1 "Proton Pump Inhibitor [EPC],Proton Pump
Inhibitors [MoA]"
33261-676_2b8c4ae6-ba9f-43d3-93d1-e731b10a0a4d 33261-676 HUMAN PRESCRIPTI
ANDA ANDA074649 Aidarex Pharmaceuticals LLC CARBAMAZEPINE 200
d Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [M
oA]"
33261-677_e4ca368f-2ead-4dd5-bdfb-53644b99e8c9 33261-677 HUMAN PRESCRIPTI
ON DRUG Venlafaxine Venlafaxine TABLET ORAL 20121130
ANDA ANDA078554 Aidarex Pharmaceuticals LLC VENLAFAXINE HYDROCHLORID
E 37.5 mg/1 "Norepinephrine Uptake Inhibitors [MoA],Serotonin and No
repinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]"
33261-679_e4ca368f-2ead-4dd5-bdfb-53644b99e8c9 33261-679 HUMAN PRESCRIPTI
ON DRUG Venlafaxine Venlafaxine TABLET ORAL 20121130
ANDA ANDA078554 Aidarex Pharmaceuticals LLC VENLAFAXINE HYDROCHLORID
E 75 mg/1 "Norepinephrine Uptake Inhibitors [MoA],Serotonin and No
33261-680_9e647b64-0405-4e32-97bd-0edb09854911 33261-680 HUMAN PRESCRIPTI
33261-683_c52564a5-732a-4f66-803b-4a3d55d53306 33261-683 HUMAN PRESCRIPTI
ON DRUG fluvoxamine maleate Fluvoxamine maleate "TABLET, COATED"
ORAL 20110809 NDA AUTHORIZED GENERIC NDA021519 Aidarex
Pharmaceuticals LLC FLUVOXAMINE MALEATE 50 mg/1 "Serotonin Reupt
33261-684_c432adf9-17a7-4c67-8488-0c67c6185103 33261-684 HUMAN PRESCRIPTI
ON DRUG Oxcarbazepine Oxcarbazepine "TABLET, FILM COATED" ORAL
OXCARBAZEPINE 150 mg/1 "Anti-epileptic Agent [EPC],Decreased Central Ne
33261-685_f88e1600-0e18-433a-90ae-1dcc7817bb59 33261-685 HUMAN PRESCRIPTI
ON DRUG Diphenoxylate Hydrochloride and Atropine Sulfate diphenox
ylate hydrochloride and atropine sulfate TABLET ORAL 20101130
ANDA ANDA085762 Aidarex Pharmaceuticals LLC ATROPINE SULFATE; DIPHEN
OXYLATE HYDROCHLORIDE .025; 2.5 mg/1; mg/1 "Antidiarrheal [EPC],Ant
icholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagoni
st [EPC],Cholinergic Muscarinic Antagonists [MoA]" CV
33261-686_d73d3c7c-5e0c-43b7-992c-105eb90c7103 33261-686 HUMAN PRESCRIPTI
ON DRUG Lexapro ESCITALOPRAM OXALATE "TABLET, FILM COATED" ORAL
ESCITALOPRAM OXALATE 20 mg/1 "Serotonin Reuptake Inhibitor [EPC],Sero
pressant [EPC]
33261-699_d73d3c7c-5e0c-43b7-992c-105eb90c7103 33261-699 HUMAN PRESCRIPTI
ON DRUG Lexapro ESCITALOPRAM OXALATE "TABLET, FILM COATED" ORAL
33261-707_a9c631b4-b783-4a4b-9b9e-f79bb60a7437 33261-707 HUMAN OTC DRUG
OTC MONOGRAPH FINAL part333B Aidarex Pharmaceuticals LLC BACITRAC
33261-714_81b5ab1e-b277-43ac-9a7b-d14d60457c12 33261-714 HUMAN PRESCRIPTI
ANDA ANDA040197 Aidarex Pharmaceuticals LLC ESTRADIOL 2
mg/1 "Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Recep
tor Agonists [MoA]"
33261-718_3c3b0660-703a-49d4-90ae-8b6a71bc049b 33261-718 HUMAN PRESCRIPTI
ON DRUG MECLIZINE HYDROCHLORIDE Meclizine Hydrocloride TABLET ORAL
MECLIZINE HYDROCHLORIDE 25 mg/1 "Antiemetic [EPC],Emesis Suppression [PE
]"
33261-724_56cf45ce-a692-486e-a961-3d53f18d418a 33261-724 HUMAN PRESCRIPTI
ON DRUG Metaxalone Metaxalone TABLET ORAL 20130531
ANDA ANDA203399 Aidarex Pharmaceuticals LLC METAXALONE 800
33261-726_2c889e7d-281d-49ad-be10-1d316637583d 33261-726 HUMAN PRESCRIPTI
Aidarex Pharmaceuticals LLC HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg
/1 "Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ing
redient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting En
33261-730_42c39262-6a30-42e7-a2a8-5b1b98a0c851 33261-730 HUMAN PRESCRIPTI
ON DRUG Ergocalciferol Ergocalciferol CAPSULE ORAL 20090817
ANDA ANDA040833 Aidarex Pharmaceuticals LLC ERGOCALCIFEROL 1.25
mg/1 "Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC]"
33261-732_2c926159-2df1-424e-b19f-197833e3dd10 33261-732 HUMAN PRESCRIPTI
ON DRUG PROMETHAZINE DM Dextromethorphan Hydrobromide and Promethazine H
ydrochloride SYRUP ORAL 20060214 ANDA ANDA040649
Aidarex Pharmaceuticals LLC DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDR
OCHLORIDE 15; 6.25 mg/5mL; mg/5mL "Uncompetitive N-methyl-D-aspart
ate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor
Antagonists [MoA],Sigma-1 Receptor Agonists [MoA],Phenothiazine [EPC],Phenothiaz
ines [Chemical/Ingredient]"
33261-737_716cfc62-96c0-46e2-aa7c-a8093b793195 33261-737 HUMAN PRESCRIPTI
ON DRUG Ofloxacin Ofloxacin SOLUTION AURICULAR (OTIC)
OFLOXACIN 3 mg/mL "Quinolone Antimicrobial [EPC],Quinolones [Chemi
cal/Ingredient]"
33261-738_e299aa52-24b3-4b98-9ea8-791b5f4c5628 33261-738 HUMAN PRESCRIPTI
ON DRUG Hydrochlorothiazide hydrochlorothiazide "CAPSULE, GELATI
N COATED" ORAL 20020917 ANDA ANDA075907 Aidarex
Pharmaceuticals LLC HYDROCHLOROTHIAZIDE 12.5 mg/1 "Increased Diure
sis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient]"
33261-739_dcbd7cb5-fde6-4c95-b453-0b5c1c8dd069 33261-739 HUMAN PRESCRIPTI
ON DRUG Ketoconazole Ketoconazole TABLET ORAL 19990615
ANDA ANDA075319 Aidarex Pharmaceuticals LLC KETOCONAZOLE 200
mg/1 "Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4
Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors
[MoA]"
uticals LLC MEDROXYPROGESTERONE ACETATE 5 mg/1 "Progesterone Co
33261-741_25385136-ce02-4fd2-a88e-e27da4b0fc0e 33261-741 HUMAN PRESCRIPTI
ON DRUG Alprazolam Alprazolam "TABLET, EXTENDED RELEASE"
LLC ALPRAZOLAM 1 mg/1 "Benzodiazepine [EPC],Benzodiazepines [C
hemical/Ingredient]" CIV
33261-745_1156d9cb-4ad2-49c0-b7ee-4b947c5dcc84 33261-745 HUMAN PRESCRIPTI
Aidarex Pharmaceuticals LLC ONDANSETRON HYDROCHLORIDE 8 mg/1
33261-747_c864bb57-bef4-4d7d-91c7-7e70ce696656 33261-747 HUMAN PRESCRIPTI
ON DRUG Ondansetron Ondansetron "TABLET, ORALLY DISINTEGRATING"
LLC ONDANSETRON 4 mg/1 "Serotonin 3 Receptor Antagonists [MoA],
Serotonin-3 Receptor Antagonist [EPC]"
33261-748_9c33b6af-82fa-46f5-805d-d2508400e10e 33261-748 HUMAN OTC DRUG
Meclizine HCl Meclizine HCl TABLET ORAL 20060714
OTC MONOGRAPH FINAL part336 Aidarex Pharmaceuticals LLC MECLIZINE HYDROC
HLORIDE 12.5 mg/1
33261-749_99e011cc-0e61-4ecd-87c7-04d397ee15e6 33261-749 HUMAN OTC DRUG
SENEXON-S DOCUSATE SODIUM -SENNOSIDES "TABLET, COATED"
ORAL 20110316 OTC MONOGRAPH NOT FINAL part334 Aidarex Pharmace
uticals LLC DOCUSATE SODIUM; SENNOSIDES A AND B 50; 8.6 mg/1; mg/1
33261-754_384c955d-a727-43b5-be9e-3e6f501cf2d3 33261-754 HUMAN PRESCRIPTI
ANDA ANDA091667 Aidarex Pharmaceuticals LLC MISOPROSTOL 100
redient]"
33261-756_5a387e4b-9fde-43fa-bd07-ac2a369147ba 33261-756 HUMAN PRESCRIPTI
ON DRUG Sulfasalazine sulfasalazine TABLET ORAL 20020111
ANDA ANDA040349 Aidarex Pharmaceuticals LLC SULFASALAZINE 500
mg/1 "Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient]"
33261-758_7e7541d1-017e-4bcc-8ae6-3735c2b5d307 33261-758 HUMAN PRESCRIPTI
ON DRUG Azathioprine Azathioprine TABLET ORAL 20070711
ANDA ANDA077621 Aidarex Pharmaceuticals LLC AZATHIOPRINE 50
mg/1 "Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Analog [Chemical/Ing
redient],Purine Antimetabolite [EPC],Purines [Chemical/Ingredient]"
33261-761_c864bb57-bef4-4d7d-91c7-7e70ce696656 33261-761 HUMAN PRESCRIPTI
LLC ONDANSETRON 8 mg/1 "Serotonin 3 Receptor Antagonists [MoA],
33261-764_b82a7117-a881-4efb-a22a-69842616fbb5 33261-764 HUMAN PRESCRIPTI
ON DRUG Spironolactone spironolactone "TABLET, FILM COATED" ORAL
SPIRONOLACTONE 100 mg/1 "Aldosterone Antagonist [EPC],Aldosterone Antago
nists [MoA]"
33261-766_12a87643-479a-4a6c-b307-646c58aa89f6 33261-766 HUMAN PRESCRIPTI
33261-770_2af6c8f6-8041-421c-943a-7ee745600a9a 33261-770 HUMAN OTC DRUG
good sense pain reliefchildrens childrens Acetaminophen SUSPENSION
ORAL 19930225 OTC MONOGRAPH NOT FINAL part343 Aidarex Pharmace
uticals LLC ACETAMINOPHEN 160 mg/5mL
33261-773_1a42734f-af17-498b-bc15-a3f7e0004fae 33261-773 HUMAN PRESCRIPTI
ON DRUG Amantadine Hydrochloride Amantadine Hydrochloride
uticals LLC AMANTADINE HYDROCHLORIDE 100 mg/1 "Influenza A M2
Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA]"
33261-780_3eb42c9e-ade5-41e9-8fb2-32551a571d28 33261-780 HUMAN PRESCRIPTI
mg/1
33261-786_fe04d17d-f5c0-4dc3-b61c-8b8a0c88f0d4 33261-786 HUMAN PRESCRIPTI
ON DRUG Metronidazole metronidazole GEL VAGINAL 20070331
NDA AUTHORIZED GENERIC NDA020208 Aidarex Pharmaceuticals LLC METRONID
AZOLE 7.5 mg/g "Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Che
mical/Ingredient]"
33261-788_096a2ff6-e875-4d62-bad8-3afa55c8fede 33261-788 HUMAN OTC DRUG
ProCoMycin "Bacitracin, Neomycin, Polymyxin B and Lidocain Hydrochl
oride" CREAM TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part348
Aidarex Pharmaceuticals LLC BACITRACIN; LIDOCAINE HYDROCHLORIDE; NEOMYCIN; P
OLYMYXIN B 500; .04; .0035; 10000 [iU]/g; g/g; g/g; [iU]/g
33261-789_4649abda-b4ec-41f8-b1bc-d1ae0aade616 33261-789 HUMAN PRESCRIPTI
ON DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION
RESPIRATORY (INHALATION) 20111205 ANDA ANDA077839
Aidarex Pharmaceuticals LLC ALBUTEROL SULFATE 2.5 mg/3mL "Adrener
gic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]"
33261-793_5de98130-babf-405b-994a-d117eef9ef57 33261-793 HUMAN PRESCRIPTI
ON DRUG Levofloxacin Levofloxacin TABLET ORAL 20110620
ANDA ANDA090367 Aidarex Pharmaceuticals LLC LEVOFLOXACIN 500
mg/1
33261-796_df8cbb50-2a88-45c4-8e36-8fdc9813aa17 33261-796 HUMAN OTC DRUG
Promolaxin Docusate sodium TABLET ORAL 20110415
OTC MONOGRAPH NOT FINAL part334 Aidarex Pharmaceuticals LLC DOCUSATE SODIUM
100 mg/1
33261-797_7b3d0f95-398a-40f5-8c02-77031cf6de12 33261-797 HUMAN PRESCRIPTI
ON DRUG Bupropion hydrochloride Bupropion hydrochloride "TABLET, FILM CO
33261-798_86561340-1ee9-44d0-adab-55bc9bbfe66a 33261-798 HUMAN OTC DRUG
Acetadryl Acetaminophen and diphenhyramine "TABLET, FILM CO
ATED" ORAL 20110721 OTC MONOGRAPH NOT FINAL part343 Aidarex
Pharmaceuticals LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25
mg/1; mg/1
pressant [EPC]
33261-810_294053a9-959b-49d5-a4e7-f0e4e2061e4e 33261-810 HUMAN PRESCRIPTI
NDA NDA018832 Aidarex Pharmaceuticals LLC ALLOPURINOL 100
33261-811_764aad3f-97f7-4762-84b8-7df245c261b6 33261-811 HUMAN PRESCRIPTI
ON DRUG Folic Acid Folic Acid TABLET ORAL 20090609
ANDA ANDA090035 Aidarex Pharmaceuticals LLC FOLIC ACID 1
mg/1
33261-813_fea6f761-235f-4d3d-99c6-6389070ec7d9 33261-813 HUMAN PRESCRIPTI
ANDA ANDA090937 Aidarex Pharmaceuticals LLC GLYBURIDE 2.5
33261-814_8d4746af-7b95-4b44-9010-cc77908c2987 33261-814 HUMAN PRESCRIPTI
ON DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride
65 Aidarex Pharmaceuticals LLC VENLAFAXINE HYDROCHLORIDE 150
mg/1 "Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reu
ptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]"
33261-816_8d4746af-7b95-4b44-9010-cc77908c2987 33261-816 HUMAN PRESCRIPTI
65 Aidarex Pharmaceuticals LLC VENLAFAXINE HYDROCHLORIDE 75
33261-817_656e9454-b292-4d3a-95d5-157e26365f3a 33261-817 HUMAN PRESCRIPTI
ON DRUG Donepezil Hydrochloride Donepezil Hydrochloride "TABLET, FILM CO
uticals LLC DONEPEZIL HYDROCHLORIDE 10 mg/1 "Cholinesterase Inhibito
33261-818_1641b016-62df-4c69-bfa4-e7b378e078bc 33261-818 HUMAN PRESCRIPTI
ON DRUG Losortan Potassium Losartan Potassium "TABLET, FILM CO
uticals LLC LOSARTAN POTASSIUM 50 mg/1 "Angiotensin 2 Receptor
Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]"
33261-820_353a5ff7-34d8-4cb4-aaab-1cba7ed4b4de 33261-820 HUMAN PRESCRIPTI
emical/Ingredient]"
33261-823_c89c67cd-6934-439f-b064-cab508c1cdda 33261-823 HUMAN PRESCRIPTI
ON DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipi
ne Besylate and Benazepril Hydrochloride CAPSULE ORAL 20100419
ANDA ANDA077183 Aidarex Pharmaceuticals LLC AMLODIPINE BESYLATE; BEN
AZEPRIL HYDROCHLORIDE 2.5; 10 mg/1; mg/1 "Calcium Channel Antagonists [Mo
A],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingr
edient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enz
yme Inhibitors [MoA],Decreased Blood Pressure [PE]"
33261-824_b544b0fa-d59a-481e-bb83-a5e49e0ad5eb 33261-824 HUMAN PRESCRIPTI
AZEPRIL HYDROCHLORIDE 5; 10 mg/1; mg/1 "Calcium Channel Antagonists [Mo
33261-825_c89c67cd-6934-439f-b064-cab508c1cdda 33261-825 HUMAN PRESCRIPTI
AMLODIPINE BESYLATE 2.5 mg/1 "Calcium Channel Antagonists [MoA],Dihyd
Aidarex Pharmaceuticals LLC HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10
33261-829_4da3b18f-eb1c-49ac-8387-07e16931208d 33261-829 HUMAN PRESCRIPTI
ED RELEASE" ORAL 19991228 ANDA ANDA075116 Aidarex
Pharmaceuticals LLC DILTIAZEM HYDROCHLORIDE 240 mg/1 "Calcium Channel
Antagonists [MoA],Calcium Channel Blocker [EPC]"
33261-830_3d03c9eb-c4a2-4d2c-9be3-3c18753096ad 33261-830 HUMAN PRESCRIPTI
ON DRUG GlipizideER ER Glipizide "TABLET, FILM COATED, EXTENDED R
uticals LLC GLIPIZIDE 5 mg/1 "Sulfonylurea [EPC],Sulfonylurea
Compounds [Chemical/Ingredient]"
33261-831_a3716d08-1cdd-4f4b-b463-d0bbca9e1e8a 33261-831 HUMAN PRESCRIPTI
ANDA ANDA091220 Aidarex Pharmaceuticals LLC GLIMEPIRIDE 2
33261-833_7cc09057-0a72-4ba6-9541-b8b5501d885f 33261-833 HUMAN PRESCRIPTI
ON DRUG Finasteride Finasteride TABLET ORAL 20121025
ANDA ANDA090061 Aidarex Pharmaceuticals LLC FINASTERIDE 5
mg/1 "5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA]"
33261-835_3d03c9eb-c4a2-4d2c-9be3-3c18753096ad 33261-835 HUMAN PRESCRIPTI
ON DRUG GlipizideER ER Glipizide "TABLET, FILM COATED, EXTENDED R
uticals LLC GLIPIZIDE 10 mg/1 "Sulfonylurea [EPC],Sulfonylurea
33261-838_77aef3a9-ef00-41af-b739-00592f4e3bdc 33261-838 HUMAN PRESCRIPTI
ON DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassi
um and Hydrochlorothiazide "TABLET, FILM COATED" ORAL 20100406
ANDA ANDA077157 Aidarex Pharmaceuticals LLC HYDROCHLOROTHIAZIDE; LOS
ARTAN POTASSIUM 12.5; 50 mg/1; mg/1 "Angiotensin 2 Receptor Antagoni
sts [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide
Diuretic [EPC],Thiazides [Chemical/Ingredient]"
33261-839_22df39d3-1e71-4b07-8d0e-9ed581d66142 33261-839 HUMAN PRESCRIPTI
ON DRUG TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE
uticals LLC TAMSULOSIN HYDROCHLORIDE 0.4 mg/1 "Adrenergic alph
a-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]"
33261-840_5a9ac93d-ff59-4778-b735-9320d48d1c31 33261-840 HUMAN PRESCRIPTI
ON DRUG Nifedipine Nifedipine "TABLET, FILM COATED, EXTENDED R
uticals LLC NIFEDIPINE 90 mg/1 "Calcium Channel Antagonists [Mo
edient]"
33261-843_b3e49f2c-8d6c-4690-863c-9417fb41ed05 33261-843 HUMAN PRESCRIPTI
ON DRUG ZONISAMIDE ZONISAMIDE CAPSULE ORAL 20051222
ANDA ANDA077636 Aidarex Pharmaceuticals LLC ZONISAMIDE 100
33261-844_02884744-7135-46f2-b795-ef42215204ec 33261-844 HUMAN PRESCRIPTI
ON DRUG NifedicalXL XL nifedipine "TABLET, FILM COATED, EXTENDED R
edient]"
33261-847_404f5030-f1b4-4756-bd33-0c2a5e7afd8a 33261-847 HUMAN PRESCRIPTI
33261-848_381aa246-233f-490b-80cb-91fef3b7bf56 33261-848 HUMAN PRESCRIPTI
CARVEDILOL 6.25 mg/1 "Adrenergic alpha-Antagonists [MoA],Adrenergic b
33261-849_dcae48af-ca48-4448-92b6-4ad661582bf4 33261-849 HUMAN PRESCRIPTI
ON DRUG Risperidone Risperidone TABLET ORAL 20090101
ANDA ANDA079088 Aidarex Pharmaceuticals LLC RISPERIDONE 1
mg/1 Atypical Antipsychotic [EPC]
33261-852_44f34237-4966-4f7f-8b00-873195c81adb 33261-852 HUMAN PRESCRIPTI
ON DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL
LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC]
33261-858_b0679889-19c0-4615-968d-a108d2482aeb 33261-858 HUMAN PRESCRIPTI
ON DRUG hydroxyzine pamoate hydroxyzine pamoate CAPSULE ORAL
HYDROXYZINE PAMOATE 50 mg/1 "Antihistamine [EPC],Histamine Receptor
Antagonists [MoA]"
33261-859_5a14624a-9938-4d95-b044-68766cf97e78 33261-859 HUMAN PRESCRIPTI
ON DRUG CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE
uticals LLC CYCLOBENZAPRINE HYDROCHLORIDE 7.5 mg/1 "Centrally-media
33261-860_0b789977-c3b1-495d-9dcb-1d7f4295eb08 33261-860 HUMAN PRESCRIPTI
ON DRUG Prazosin Hydrochloride Prazosin Hydrochloride CAPSULE ORAL
PRAZOSIN HYDROCHLORIDE 1 mg/1 "Adrenergic alpha-Antagonists [MoA],alph
a-Adrenergic Blocker [EPC]"
33261-861_0b789977-c3b1-495d-9dcb-1d7f4295eb08 33261-861 HUMAN PRESCRIPTI
PRAZOSIN HYDROCHLORIDE 2 mg/1 "Adrenergic alpha-Antagonists [MoA],alph
a-Adrenergic Blocker [EPC]"
33261-865_d3cfec5b-8dfb-4138-8ee0-09bf49a5c38e 33261-865 HUMAN PRESCRIPTI
uticals LLC PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 "Phenothiazine [
33261-867_74ec5981-fcf7-4164-a03f-2d6656a5f46f 33261-867 HUMAN PRESCRIPTI
ON DRUG pravastatin sodium pravastatin sodium TABLET ORAL
PRAVASTATIN SODIUM 20 mg/1 "HMG-CoA Reductase Inhibitor [EPC],Hydro
xymethylglutaryl-CoA Reductase Inhibitors [MoA]"
nists [MoA]"
C]"
33261-871_b467b2f6-9ecd-45be-a714-664764233d01 33261-871 HUMAN PRESCRIPTI
ON DRUG Minocycline hydrochloride Minocycline hydrochloride
uticals LLC MINOCYCLINE HYDROCHLORIDE 50 mg/1 "Tetracycline-cl
33261-873_363f91f4-00cf-461e-b14b-85923fed3331 33261-873 HUMAN PRESCRIPTI
ON DRUG ADVAIR DISKUS fluticasone propionate and salmeterol POWDER RESPIRAT
ORY (INHALATION) 20010228 NDA NDA021077 Aidarex
Pharmaceuticals LLC FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 100; 50
ug/1; ug/1 "Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]"
33261-874_363f91f4-00cf-461e-b14b-85923fed3331 33261-874 HUMAN PRESCRIPTI
ON DRUG ADVAIR DISKUS fluticasone propionate and salmeterol POWDER RESPIRAT
ORY (INHALATION) 20010205 NDA NDA021077 Aidarex
Pharmaceuticals LLC FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 250; 50
ug/1; ug/1 "Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]"
mg/1
33261-879_335dec43-2c8b-4432-81e1-f9284a7a834f 33261-879 HUMAN PRESCRIPTI
33261-881_f26159f5-60aa-4a4a-a320-b66414967604 33261-881 HUMAN PRESCRIPTI
ON DRUG Hydrocodone Bitartate and Acetaminophen "HYDROCODONE BITARTRATE,
ACETAMINOPHEN" TABLET ORAL 20120517 ANDA ANDA040846
Aidarex Pharmaceuticals LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 2.5
mg/1; mg/1 "Opioid Agonist [EPC],Opioid Agonists [MoA]" CIII
33261-883_3b58ae4d-381a-4d4d-85db-afb884621916 33261-883 HUMAN PRESCRIPTI
ON DRUG Fluoxetine fluoxetine CAPSULE ORAL 20050720
ANDA ANDA076990 Aidarex Pharmaceuticals LLC FLUOXETINE HYDROCHLORIDE
[MoA]"
33261-884_c8bbb594-e795-431e-aeb8-800da6a7db1f 33261-884 HUMAN OTC DRUG
MEDROX "MENTHOL, CAPSAICIN" PATCH TOPICAL 20120613
OTC MONOGRAPH NOT FINAL part348 Aidarex Pharmaceuticals LLC CAPSAICIN; MENTH
OL .0375; 5 g/100g; g/100g
33261-888_fdb92d03-2a1a-4b64-ad4f-391f8f977bb8 33261-888 HUMAN PRESCRIPTI
ON DRUG Doxycycline Hyclate Doxycycline Hyclate "TABLET, FILM CO
uticals LLC DOXYCYCLINE HYCLATE 20 mg/1
mg/1
33261-892_0bbcdb96-76b4-4d74-a385-9ead00baa8ef 33261-892 HUMAN PRESCRIPTI
ANDA ANDA077091 Aidarex Pharmaceuticals LLC GLIMEPIRIDE 4
nists [MoA]"
33261-896_a7bdbe31-8699-40f4-b6a1-d30b99cb97ec 33261-896 HUMAN PRESCRIPTI
ON DRUG Nystatin nystatin "TABLET, FILM COATED" ORAL
NYSTATIN 500000 [USP'U]/1 "Polyene Antifungal [EPC],Polyenes [Chem
ical/Ingredient]"
33261-898_f6787aa2-956b-47da-91fd-cdc7d8695df9 33261-898 HUMAN PRESCRIPTI
ON DRUG Metoprolol succinate Metoprolol succinate "TABLET, EXTENDE
Pharmaceuticals LLC METOPROLOL SUCCINATE 25 mg/1 "Adrenergic beta
33261-899_e1ddd097-1fc0-467c-b770-4e815160bc04 33261-899 HUMAN PRESCRIPTI
33261-900_ca6dd35c-a11d-498f-9086-9fd681470743 33261-900 HUMAN PRESCRIPTI
ON DRUG Atovaquone and Proguanil Hydrochloride Atovaquone and Proguanil
ANDA091211 Aidarex Pharmaceuticals LLC ATOVAQUONE; PROGUANIL HYDROCHLOR
IDE 250; 100 mg/1; mg/1 "Antimalarial [EPC],Antiprotozoal [EPC],
Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA]"
33261-903_1ecbc0cc-35c9-46ff-b07d-b7d1ae7a9335 33261-903 HUMAN PRESCRIPTI
ANDA ANDA091604 Aidarex Pharmaceuticals LLC RAMIPRIL 5
33261-904_b125e99c-f968-4ece-9c23-64aa5b1e4986 33261-904 HUMAN PRESCRIPTI
um and Hydrochlorothiazide TABLET ORAL 20101006 ANDA
ANDA077732 Aidarex Pharmaceuticals LLC HYDROCHLOROTHIAZIDE; LOSARTAN PO
TASSIUM 25; 100 mg/1; mg/1 "Angiotensin 2 Receptor Antagonists [MoA],Angiot
ensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],T
hiazides [Chemical/Ingredient]"
33261-905_bb942e65-f5fb-4d99-801e-79c6b680e217 33261-905 HUMAN PRESCRIPTI
ON DRUG Cefdinir Cefdinir "POWDER, FOR SUSPENSION"
LLC CEFDINIR 250 mg/5mL "Cephalosporin Antibacterial [EPC],Cepha
losporins [Chemical/Ingredient]"
33261-907_4da79ad0-8d67-4080-82db-8cab5f049213 33261-907 HUMAN PRESCRIPTI
ON DRUG Hyoscyamine Sulfate Extended-Release Hyoscyamine Sulfate Exte
nded-Release TABLET ORAL 20100103 UNAPPROVED DRUG OTHER
Aidarex Pharmaceuticals LLC HYOSCYAMINE SULFATE 0.375 mg/1
33261-908_c378686f-8bf4-4fff-9b88-d5a18ce37135 33261-908 HUMAN OTC DRUG
Childrens Loratadine Loratadine SOLUTION ORAL 20040820
ANDA ANDA076805 Aidarex Pharmaceuticals LLC LORATADINE 5
mg/5mL
33261-918_67b56f89-ea09-427c-95ff-f358b6eb256e 33261-918 HUMAN PRESCRIPTI
ON DRUG bisoprolol fumarate and hydrochlorothiazide bisoprolol fumar
ate and hydrochlorothiazide TABLET ORAL 20101012 ANDA
ANDA079106 Aidarex Pharmaceuticals LLC BISOPROLOL FUMARATE; HYDROCHLORO
THIAZIDE 5; 6.25 mg/1; mg/1 "Adrenergic beta-Antagonists [MoA],beta-
Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazid
es [Chemical/Ingredient]"
33261-922_208b6d91-6e3f-48ac-a86d-767e735dadb8 33261-922 HUMAN PRESCRIPTI
ON DRUG "Butalbital, Aspirin, and Caffeine" "butalbital, aspirin, an
d caffeine" CAPSULE ORAL 19760504 NDA AUTHORIZED GENERIC
NDA017534 Aidarex Pharmaceuticals LLC ASPIRIN; BUTALBITAL; CAFFEINE
325; 50; 40 mg/1; mg/1; mg/1 "Barbiturate [EPC],Barbiturates [Chemica
l/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production
[PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroida
l Anti-inflammatory Drug [EPC],Central Nervous System Stimulant [EPC],Central Ne
rvous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredien
t]" CIII
33261-933_ba4280ea-864c-4f79-97f9-7438fa0a6105 33261-933 HUMAN PRESCRIPTI
ON DRUG Hydroxychloroquine Sulfate Hydroxychloroquine Sulfate
Aidarex Pharmaceuticals LLC HYDROXYCHLOROQUINE SULFATE 200 mg/1
Antirheumatic Agent [EPC]
33261-942_ca7a45f2-b48d-45b1-ab29-53da0dd9cf71 33261-942 HUMAN PRESCRIPTI
ON DRUG Atenolol and Chlorthalidone Atenolol and Chlorthalidone
uticals LLC ATENOLOL; CHLORTHALIDONE 50; 25 mg/1; mg/1 "Adrener
gic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE]
,Thiazide-like Diuretic [EPC]"
33261-946_d62710fe-d3d0-4714-b3bb-e1f6dd916946 33261-946 HUMAN PRESCRIPTI
33261-947_803c7ca1-ccca-4d6f-9365-d0c26530700a 33261-947 HUMAN PRESCRIPTI
ON DRUG Levocetirizine Dihydrochloride Levocetirizine Dihydrochloride
Aidarex Pharmaceuticals LLC LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1
"Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]"
33261-950_77aef3a9-ef00-41af-b739-00592f4e3bdc 33261-950 HUMAN PRESCRIPTI
ANDA ANDA077157 Aidarex Pharmaceuticals LLC HYDROCHLOROTHIAZIDE; LOS
33261-951_a87947cb-f21c-4345-a83d-03518b670e9e 33261-951 HUMAN PRESCRIPTI
uticals LLC DILTIAZEM HYDROCHLORIDE 120 mg/1 "Calcium Channel Antagon
33261-952_6316b11a-923a-4944-b814-31bd8a934db9 33261-952 HUMAN PRESCRIPTI
ON DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochl
orothiazide TABLET ORAL 20090921 ANDA ANDA071251
Aidarex Pharmaceuticals LLC HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5
mg/1; mg/1 "Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potas
sium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thia
zides [Chemical/Ingredient]"
33261-954_4cae7a30-ddc2-4e4f-b4c5-17d8eb69ee78 33261-954 HUMAN PRESCRIPTI
33261-955_fff7cc6b-ece8-4ff9-942d-118822b5eae5 33261-955 HUMAN PRESCRIPTI
ON DRUG escitalopram oxalate escitalopram oxalate TABLET ORAL
33261-956_210af85b-9e0f-4bd9-94f9-77ffe42b013f 33261-956 HUMAN PRESCRIPTI
ON DRUG Econazole Nitrate Econazole Nitrate CREAM TOPICAL
ECONAZOLE NITRATE 10 mg/g "Azole Antifungal [EPC],Azoles [Chemical
/Ingredient]"
33261-959_9c180770-0e8d-4dde-b049-8b3a615cf105 33261-959 HUMAN PRESCRIPTI
ON DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM "TABLET, FILM CO
uticals LLC ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 10 mg/1
"HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitor
s [MoA]"
33261-963_265be229-6d0b-4ceb-a94a-7f84ca2c3141 33261-963 HUMAN PRESCRIPTI
uticals LLC DICYCLOMINE HYDROCHLORIDE 10 mg/1 "Anticholinergic
33261-964_2e490478-f34d-4b76-bdac-b9678042bb3a 33261-964 HUMAN PRESCRIPTI
ON DRUG Liothyronine Sodium Liothyronine Sodium TABLET ORAL
LIOTHYRONINE SODIUM 5 ug/1 "l-Triiodothyronine [EPC],Triiodothyroni
ne [Chemical/Ingredient]"
33261-966_7cab8cc1-8128-45fc-87a2-639f07d4d60f 33261-966 HUMAN PRESCRIPTI
ON DRUG FENOFIBRATE FENOFIBRATE TABLET ORAL 20100201
ANDA ANDA076509 Aidarex Pharmaceuticals LLC FENOFIBRATE 54
mg/1 "Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Prolife
rator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient]"
33261-967_1ecbc0cc-35c9-46ff-b07d-b7d1ae7a9335 33261-967 HUMAN PRESCRIPTI
ANDA ANDA091604 Aidarex Pharmaceuticals LLC RAMIPRIL 10
33261-969_733ee823-ddd2-45b5-9d27-44105e5bf34c 33261-969 HUMAN PRESCRIPTI
ON DRUG montelukast sodium montelukast sodium "TABLET, FILM CO
uticals LLC MONTELUKAST SODIUM 10 mg/1 "Leukotriene Receptor An
tagonist [EPC],Leukotriene Receptor Antagonists [MoA]"
33261-970_2fce4fed-89a2-4fa9-a1b0-a8dc087ae983 33261-970 HUMAN PRESCRIPTI
ON DRUG Amoxicillin and Clavulanate Potassium amoxicillin and clavulan
NDA NDA050755 Aidarex Pharmaceuticals LLC AMOXICILLIN; CLAVULANATE
33261-972_4cea1f5c-07d8-4ae8-8d22-5578b510c62d 33261-972 HUMAN PRESCRIPTI
ON DRUG Atorvastatin Calcium Atorvastatin Calcium "TABLET, FILM CO
uticals LLC ATORVASTATIN CALCIUM TRIHYDRATE 20 mg/1 "HMG-CoA Reducta
se Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"
33261-975_725bef53-880f-4402-8b86-b732911c80bf 33261-975 HUMAN PRESCRIPTI
33261-982_bbb38451-c948-492b-9998-cebf028a6052 33261-982 HUMAN PRESCRIPTI
33261-983_ae72cf6a-bf5f-424c-8d8c-1aaffbb89826 33261-983 HUMAN PRESCRIPTI
ON DRUG Bumetanide Bumetanide TABLET ORAL 20071016
ANDA ANDA074225 Aidarex Pharmaceuticals LLC BUMETANIDE 1
33261-986_725bef53-880f-4402-8b86-b732911c80bf 33261-986 HUMAN PRESCRIPTI
33261-987_0ea55b0e-a44e-4b1f-be1b-314d92b7ccc2 33261-987 HUMAN PRESCRIPTI
ON DRUG Clopidogrel Clopidogrel Bisulfate "TABLET, FILM COATED"
LLC CLOPIDOGREL BISULFATE 75 mg/1 "Decreased Platelet Aggregation
[PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA]"
33261-988_0793439e-5691-4317-b98d-66079435969e 33261-988 HUMAN PRESCRIPTI
hibitors [MoA]"
33261-989_603f002e-7b62-4777-be74-66e0ffffb894 33261-989 HUMAN PRESCRIPTI
hibitors [MoA]"
33261-992_c85bc0c3-d37b-454b-ba21-199a6d33e9ba 33261-992 HUMAN PRESCRIPTI
ON DRUG PENTOXIFYLLINE PENTOXIFYLLINE "TABLET, EXTENDED RELEASE"
LLC PENTOXIFYLLINE 400 mg/1 "Blood Viscosity Reducer [EPC],Hematolog
ic Activity Alteration [PE]"
33261-993_78a8700b-3eb9-4c00-b274-3bddc6208a34 33261-993 HUMAN PRESCRIPTI
emical/Ingredient]"
33261-994_49778501-d326-4ead-9fa5-b9d30228ff2d 33261-994 HUMAN PRESCRIPTI
ON DRUG Alfuzosin Hydrochloride Alfuzosin Hydrochloride "TABLET, EXTENDE
Pharmaceuticals LLC ALFUZOSIN HYDROCHLORIDE 10 mg/1 "Adrenergic alph
53217-001_69b4a3d6-0e03-4e4b-9377-0926bae0faef 53217-001 HUMAN PRESCRIPTI
53217-003_d8132b9b-3eb6-4b19-a8cc-4a67712e19d0 53217-003 HUMAN PRESCRIPTI
ON DRUG CAPTOPRIL CAPTOPRIL TABLET ORAL 19970328
ANDA ANDA074532 Aidarex Pharmaceuticals LLC CAPTOPRIL 12.5
53217-004_2d60485d-d6e7-47d7-813d-0db3a3214e20 53217-004 HUMAN OTC DRUG
New Terocin "Methyl Salicylate, Capsaicin, and Menthol" LOTION
TOPICAL 20130313 OTC MONOGRAPH NOT FINAL part348 Aidarex Pharmace
uticals LLC CAPSAICIN; MENTHOL; METHYL SALICYLATE .025; 10; 25 g/100mL;
g/100mL; g/100mL
53217-005_8da49cda-f1fa-4227-9892-57f67235f68b 53217-005 HUMAN PRESCRIPTI
ON DRUG DIGOX Digoxin TABLET ORAL 20020726 ANDA
ANDA076268 Aidarex Pharmaceuticals LLC DIGOXIN 250 ug/1 "Cardiac
Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient]"
53217-006_6947b532-323d-413d-b76d-7ea159b285b7 53217-006 HUMAN PRESCRIPTI
53217-007_de01a1bf-91d5-43b3-b516-dfa6fb5d4316 53217-007 HUMAN PRESCRIPTI
ON DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride
Aidarex Pharmaceuticals LLC HYDROXYZINE HYDROCHLORIDE 50 mg/1
"Antihistamine [EPC],Histamine Receptor Antagonists [MoA]"
53217-008_3a79526b-bcfe-4635-82a6-73cafe9b13eb 53217-008 HUMAN PRESCRIPTI
ON DRUG Ipratropium Bromide Ipratropium Bromide SOLUTION
Aidarex Pharmaceuticals LLC IPRATROPIUM BROMIDE 0.5 mg/2.5mL
"Anticholinergic [EPC],Cholinergic Antagonists [MoA]"
53217-009_9be2d0a1-1415-47de-87f0-03a66680c62f 53217-009 HUMAN PRESCRIPTI
ON DRUG Lactulose Lactulose SOLUTION ORAL 19950703
ANDA ANDA074076 Aidarex Pharmaceuticals LLC LACTULOSE 10
g/15mL "Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA]
,Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"
53217-010_c8bbdb77-8cb5-437b-96b7-a064ba98c84d 53217-010 HUMAN PRESCRIPTI
ON DRUG NifedicalXL XL nifedipine "TABLET, FILM COATED, EXTENDED R
edient]"
53217-011_909139f0-c2f9-4004-a245-b38cf54c4869 53217-011 HUMAN PRESCRIPTI
ON DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL
SOTALOL HYDROCHLORIDE 80 mg/1 Antiarrhythmic [EPC]
53217-012_8d6a065d-30d4-4b0d-a51e-cc101b8271a8 53217-012 HUMAN PRESCRIPTI
ANDA ANDA075743 Aidarex Pharmaceuticals LLC LISINOPRIL 2.5
53217-014_278d33d3-ae7b-40ec-9ff4-8f6d667e3f50 53217-014 HUMAN PRESCRIPTI
ON DRUG Triamcinolone Acetonide triamcinolone acetonide CREAM TOPICAL
TRIAMCINOLONE ACETONIDE 0.25 mg/g
53217-015_60077487-aec7-4042-99ec-6f531bb31fdf 53217-015 HUMAN PRESCRIPTI
ON DRUG Ketoconazole Ketoconazole "SHAMPOO, SUSPENSION" TOPICAL
KETOCONAZOLE 20 mg/mL "Azole Antifungal [EPC],Azoles [Chemical/Ingredi
ent],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P
-Glycoprotein Inhibitors [MoA]"
53217-018_569f166d-b427-4409-9418-8432052de580 53217-018 HUMAN PRESCRIPTI
ON DRUG Warfarin Sodium Warfarin TABLET ORAL 20100816
ANDA ANDA202202 Aidarex Pharmaceuticals LLC WARFARIN SODIUM 7.5
53217-019_3a77ea51-3169-45d6-ae45-7e2bdaea2347 53217-019 HUMAN PRESCRIPTI
ON DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride
Aidarex Pharmaceuticals LLC HYDRALAZINE HYDROCHLORIDE 50 mg/1
"Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]"
53217-020_3322107f-096e-40f9-96be-bcd71578c47f 53217-020 HUMAN PRESCRIPTI
ON DRUG Hydrocodone Bitartrate and Acetaminophen HYDROCODONE BITA
RTRATE and ACETAMINOPHEN SOLUTION ORAL 20110101
ANDA ANDA040182 Aidarex Pharmaceuticals LLC ACETAMINOPHEN; HYDROCODO
NE BITARTRATE 167; 2.5 mg/5mL; mg/5mL "Opioid Agonist [EPC],Opioid Ago
nists [MoA]" CIII
53217-021_c7176ee9-dfa5-47e9-b972-17c2273a81ea 53217-021 HUMAN PRESCRIPTI
ON DRUG Erythromycin Erythromycin GEL TOPICAL 20080612
ANDA ANDA063211 Aidarex Pharmaceuticals LLC ERYTHROMYCIN 20
mg/g "Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antim
icrobial [EPC],Macrolides [Chemical/Ingredient]"
53217-022_342bbf92-0160-4f92-b1ce-98cedd5fd6d5 53217-022 HUMAN PRESCRIPTI
ANDA ANDA062840 Aidarex Pharmaceuticals LLC NYSTATIN 100000
53217-024_0b3cb041-1d4b-486d-937b-95e06b0b9882 53217-024 HUMAN OTC DRUG
ROBAFEN COUGH FORMULA Guaifenesin SYRUP ORAL 20120815
OTC MONOGRAPH FINAL part341 Aidarex Pharmaceuticals LLC GUAIFENESIN
100 mg/5mL
53217-026_bcc54b4f-bf01-40dc-82e3-633f8bb1054a 53217-026 HUMAN OTC DRUG
LenzaGel "LIDOCAINE HYDROCHLORIDE, MENTHOL" GEL TOPICAL
20130301 OTC MONOGRAPH NOT FINAL part348 Aidarex Pharmaceuticals
LLC LIDOCAINE HYDROCHLORIDE; MENTHOL 4; 1 g/100g; g/100g
53217-054_7e0d9034-c76b-4349-8443-ababb9db92a3 53217-054 HUMAN PRESCRIPTI
ON DRUG VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE
Aidarex Pharmaceuticals LLC VALACYCLOVIR HYDROCHLORIDE 500 mg/1
"DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Poly
merase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhi
bitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleos
ide Analog [Chemical/Ingredient]"
53217-058_c5eb25f0-c650-4cc7-8f2c-60574e93c8fc 53217-058 HUMAN OTC DRUG
Bismatrol Bismuth subsalicylate "TABLET, CHEWABLE" ORAL
LLC BISMUTH SUBSALICYLATE 262 mg/1
53217-060_55591708-1dc9-45bb-8870-12609d4b51c7 53217-060 HUMAN OTC DRUG
Bismatrol Bismuth Subsalicylate LIQUID ORAL 20080530
OTC MONOGRAPH FINAL part335 Aidarex Pharmaceuticals LLC BISMUTH SUBSALIC
YLATE 262 mg/15mL
53217-063_b50ba291-8672-4722-99a8-73aa624ad39b 53217-063 HUMAN PRESCRIPTI
ON DRUG Hyoscyamine Sulfate Hyoscyamine Sulfate TABLET ORAL
LLC HYOSCYAMINE SULFATE 0.125 mg/1
53217-064_66c9882a-58ad-4edd-8183-db4352828a50 53217-064 HUMAN PRESCRIPTI
ON DRUG Lidocaine Hydrochloride Lidocaine GEL TOPICAL 20130301
UNAPPROVED DRUG OTHER Aidarex Pharmaceuticals LLC LIDOCAINE
30 mg/g "Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antia
rrhythmic [EPC],Local Anesthesia [PE]"
53217-066_1ffe0c86-333f-4852-9051-3c98411e494d 53217-066 HUMAN PRESCRIPTI
ON DRUG Nitrostat nitroglycerin TABLET SUBLINGUAL 20000501
NDA NDA021134 Aidarex Pharmaceuticals LLC NITROGLYCERIN 0.4
mg/1 "Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [
PE]"
53217-070_9e51fa64-b081-4deb-8f8c-a21836a381d4 53217-070 HUMAN PRESCRIPTI
ON DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL
DOXEPIN HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC]
62737-123_477f641f-a3fc-4b98-813b-c1779937b2d4 62737-123 HUMAN PRESCRIPTI
ON DRUG Oxygen oxygen GAS RESPIRATORY (INHALATION) 19960419
UNAPPROVED MEDICAL GAS Air Care Home Health Inc OXYGEN 1
L/L
10671-010_68377a13-91ca-43a2-8076-075f5759cad5 10671-010 HUMAN PRESCRIPTI
NDA NDA205827 Air Liquide America L.P. OXYGEN 99 L/100L
10671-011_88eec941-277a-4f7f-a7af-149e8d34441f 10671-011 HUMAN PRESCRIPTI
10671-013_9f31c74c-73b0-4ca5-a2d9-23f9f4bfbad7 10671-013 HUMAN PRESCRIPTI
10671-020_53cc9f2c-4a98-4bd4-af80-d7bfc63398fc 10671-020 HUMAN PRESCRIPTI
19600101 NDA NDA205829 Air Liquide America L.P.
NITROGEN 99 L/100L
ON DRUG NITROGEN NITROGEN LIQUID RESPIRATORY (INHALATION)
NITROGEN 99 L/100L
NITROGEN 99 L/100L
NITROGEN 99 L/100L
10671-100_4e255a48-1d39-477e-b24c-f4d814c83cb7 10671-100 HUMAN PRESCRIPTI
ON DRUG EZ-OX OXYGEN GAS RESPIRATORY (INHALATION) 19600101
10671-101_5e617966-03e2-48f3-b2f9-b5a48087dd54 10671-101 HUMAN PRESCRIPTI
ON DRUG EZ-OX Plus EZ-OX Plus GAS RESPIRATORY (INHALATION)
OXYGEN 99 L/100L
42411-010_a41516d7-1490-46c5-82bc-297c21388258 42411-010 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS Air Liquide America Specialty Gases LLC OXYGEN
99 L/100L
42411-011_c4002477-9270-45f7-9ad0-07b8df4bc5ab 42411-011 HUMAN PRESCRIPTI
ON DRUG Oxygen Oxygen LIQUID RESPIRATORY (INHALATION) 19600101
99 L/100L
42411-012_19223e6b-a790-41e8-9020-ba390fc0a30d 42411-012 HUMAN PRESCRIPTI
ON DRUG Oxygen Oxygen LIQUID RESPIRATORY (INHALATION) 19600101
99 L/100L
42411-020_763ca076-90f8-47b4-a015-6a996b5b206d 42411-020 HUMAN PRESCRIPTI
19600101 UNAPPROVED MEDICAL GAS Air Liquide America Spec
ialty Gases LLC NITROGEN 99 L/100L
42411-021_8f67bc0f-b440-4332-ab1b-8c18a311ffb7 42411-021 HUMAN PRESCRIPTI
ON DRUG Nitrogen Nitrogen LIQUID RESPIRATORY (INHALATION)
42411-022_c4c01bd6-998f-4e31-8af3-df09ebfff555 42411-022 HUMAN PRESCRIPTI
ON DRUG Nitrogen Nitrogen LIQUID RESPIRATORY (INHALATION)
42411-030_5b402658-8be4-42b4-b8ba-d13a1f3a75d8 42411-030 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS Air Liquide America Specialty Gases LLC HELIUM
99 L/100L
42411-040_5779524a-129b-4b58-bb79-6dff780b1fbc 42411-040 HUMAN PRESCRIPTI
19600101 NDA NDA205704 Air Liquide America Specialty Ga
ses LLC NITROUS OXIDE 99 L/100L
42411-041_17030ad0-2311-4a1a-bc8b-88dd160588b1 42411-041 HUMAN PRESCRIPTI
ON DRUG NITROUS OXIDE NITROUS OXIDE LIQUID RESPIRATORY (INHALATION)
42411-043_96a4a2a2-5aa0-4af5-81ae-e8a3eee5d043 42411-043 HUMAN PRESCRIPTI
42411-050_bb904109-cddf-4692-835e-84e587b3520f 42411-050 HUMAN PRESCRIPTI
ialty Gases LLC CARBON DIOXIDE 99 L/100L "Radiographic Contrast Agent [EP
42411-051_bb67f245-8ff5-4cdd-b365-7fd952e4efb9 42411-051 HUMAN PRESCRIPTI
ON DRUG Carbon Dioxide Carbon Dioxide LIQUID RESPIRATORY (INHALATION)
ialty Gases LLC CARBON DIOXIDE 99 L/100L "Radiographic Contrast Agent [EP
42411-060_e7256700-d66d-4e48-a4e0-1bc67bb1303a 42411-060 HUMAN PRESCRIPTI
ON DRUG Carbon Dioxide Oxygen Mixture Carbon Dioxide Oxygen Mixture
AL GAS Air Liquide America Specialty Gases LLC CARBON DIOXIDE; OXYGEN
5; 95 L/100L; L/100L "Radiographic Contrast Agent [EPC],X-Ray Contrast Activi
ty [MoA]"
42411-070_a0c8710e-5369-4693-a0f3-845e26dc2981 42411-070 HUMAN PRESCRIPTI
ON DRUG Helium Oxygen Mixture Helium Oxygen Mixture GAS RESPIRAT
Air Liquide America Specialty Gases LLC HELIUM; OXYGEN 60; 40 L/100L; L/100L
42411-074_1d892e2a-f152-414f-ba0d-3bdfee7da02b 42411-074 HUMAN PRESCRIPTI
Air Liquide America Specialty Gases LLC HELIUM; OXYGEN 80; 20 L/100L; L/100L
42411-080_3af56661-23fc-4b40-8c39-ed380814e190 42411-080 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS Air Liquide America Specialty Gases LLC NITROGEN
; OXYGEN 77; 23 L/100L; L/100L
42411-100_c8fa624d-3ca1-4778-a1f1-de43240769d8 42411-100 HUMAN PRESCRIPTI
ON DRUG EZ-Ox EZ-Ox GAS RESPIRATORY (INHALATION) 19600101
99 L/100L
42411-101_4d9739a9-48fd-4004-a4ad-562d5ba8419e 42411-101 HUMAN PRESCRIPTI
ON DRUG EZ-Ox Plus EZ-Ox Plus GAS RESPIRATORY (INHALATION)
ialty Gases LLC OXYGEN 99 L/100L
64735-010_500fcd34-2b8b-42ac-9ee0-dc90e7d5a690 64735-010 HUMAN PRESCRIPTI
NDA NDA205712 Air Liquide Healthcare America Corporation OXYGEN
99 L/100L
64735-011_71a14136-8e51-4ad1-8710-decb6ab4879f 64735-011 HUMAN PRESCRIPTI
ON DRUG OXYGEN OXYGEN LIQUID RESPIRATORY (INHALATION) 19600101
99 L/100L
64735-020_780ada88-3f29-44c5-8c44-fb2f1cc3aef0 64735-020 HUMAN PRESCRIPTI
19600101 NDA NDA205713 Air Liquide Healthcare America C
orporation NITROGEN 99 L/100L
64735-021_1853c4ee-bf32-4c8a-be49-6576ebcc33e9 64735-021 HUMAN PRESCRIPTI
64735-022_86414780-f026-421c-9a3c-ed78bf1d0083 64735-022 HUMAN PRESCRIPTI
64735-030_9fcf3e30-349e-43a9-8f20-9d40ea34374c 64735-030 HUMAN PRESCRIPTI
NDA NDA206026 Air Liquide Healthcare America Corporation HELIUM
99 L/100L
64735-040_236e4586-d9aa-4868-9142-548dd15ce6a0 64735-040 HUMAN PRESCRIPTI
orporation NITROUS OXIDE 99 L/100L
64735-041_8ef525aa-a792-4797-8a4c-e647866a8461 64735-041 HUMAN PRESCRIPTI
orporation NITROUS OXIDE 99 L/100L
64735-050_10c6d0b3-cf20-4328-b748-336c43122bc0 64735-050 HUMAN PRESCRIPTI
orporation CARBON DIOXIDE 99 L/100L "Radiographic Contrast Agent [EP
64735-060_f825b8ce-57e8-45ff-ae70-420e8057efb1 64735-060 HUMAN PRESCRIPTI
AL GAS Air Liquide Healthcare America Corporation CARBON DIOXIDE;
OXYGEN 5; 95 L/100L; L/100L "Radiographic Contrast Agent [EPC],X-Ray Contras
t Activity [MoA]"
64735-070_2c1e32b8-7d04-46a2-bffe-e5d541bb087a 64735-070 HUMAN PRESCRIPTI
ON DRUG "COMPRESSED GAS, OXIDIZING, N.O.S." OXYGEN GAS RESPIRAT
ORY (INHALATION) 19600101 NDA NDA205712 Air Liqu
ide Healthcare America Corporation OXYGEN 40 L/100L
64735-074_4ba48103-6eec-4d8d-b66b-e0049768c621 64735-074 HUMAN PRESCRIPTI
ON DRUG "COMPRESSED GAS, N.O.S." OXYGEN GAS RESPIRATORY (INH
ALATION) 19600101 NDA NDA205712 Air Liquide Heal
thcare America Corporation OXYGEN 20 L/100L
64735-080_7777e939-2a5d-4af2-918d-f1f80e317e0c 64735-080 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS Air Liquide Healthcare America Corporation
NITROGEN; OXYGEN 77; 23 L/100L; L/100L
64735-100_388a34eb-a60f-4618-b20c-db3204ab7016 64735-100 HUMAN PRESCRIPTI
ON DRUG EZ-OX OXYGEN GAS RESPIRATORY (INHALATION) 19600101
99 L/100L
64735-101_2075df56-d462-4207-a599-ed867a0cf3dd 64735-101 HUMAN PRESCRIPTI
ON DRUG EZ-OX PLUS OXYGEN GAS RESPIRATORY (INHALATION)
orporation OXYGEN 99 L/100L
11917-013_7ed190af-6031-426f-8b93-c3e0f85fdc1a 11917-013 HUMAN PRESCRIPTI
NDA NDA205712 Air Liquide Industrial U.S. LP OXYGEN 99 L/100L
11853-013_9f685625-2ba7-45e5-a05a-3f825b5b5c96 11853-013 HUMAN PRESCRIPTI
NDA NDA205737 Air Liquide Large Industries U.S. LP OXYGEN 99
L/100L
11853-023_22f24ea2-0a78-423b-82a4-df94d785ac34 11853-023 HUMAN PRESCRIPTI
19600101 NDA NDA205738 Air Liquide Large Industries U.S
. LP NITROGEN 99 L/100L
10018-8999_7eeeb31e-890b-4b18-a36a-51f11fdcf88c 10018-8999 HUMAN PRESCRIPTI
NDA NDA205865 "Air Products and Chemicals, Inc." OXYGEN 990
mL/L
10018-9502_c12d5de2-dd87-4db2-bcf8-48c7239ed8ed 10018-9502 HUMAN PRESCRIPTI
20050101 NDA NDA205866 "Air Products and Chemicals, Inc
." NITROGEN 990 mL/L
10018-9505_6bbe6aca-7f15-4823-9440-abba441bcbe0 10018-9505 HUMAN PRESCRIPTI
NDA NDA205864 "Air Products and Chemicals, Inc." HELIUM 990
mL/L
10167-100_9d16ab39-6f97-4d12-b3de-fd9890502eae 10167-100 HUMAN PRESCRIPTI
ON DRUG OXYGEN 0XYGEN GAS RESPIRATORY (INHALATION) 19920101
UNAPPROVED MEDICAL GAS Air Source Industries Inc OXYGEN 99
L/100L
10167-200_a78f34d2-9571-482c-b495-b76c5efa8362 10167-200 HUMAN PRESCRIPTI
19920101 UNAPPROVED MEDICAL GAS Air Source Industries In
c NITROUS OXIDE 99 L/100L
10167-300_c8afd333-d689-47bb-a635-e7484a20c6c0 10167-300 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS Air Source Industries Inc HELIUM 99
L/100L
10167-400_c155ee73-e67f-4e5e-89a5-f54f0787d2ef 10167-400 HUMAN PRESCRIPTI
c NITROGEN 99 L/100L
10167-500_7c576308-42c1-41a0-85f7-9bf394165ad8 10167-500 HUMAN PRESCRIPTI
c CARBON DIOXIDE 99 L/100L "Radiographic Contrast Agent [EPC],X-Ray
Contrast Activity [MoA]"
10167-600_e32119d7-9b67-4d82-bfed-8ee68d5d631a 10167-600 HUMAN PRESCRIPTI
ON DRUG AIR COMPRESSED AIR COMPRESSED GAS RESPIRATORY (INHALATION)
c OXYGEN 20 L/100L
24306-123_2680d774-848e-4be0-936d-3762a04b93dd 24306-123 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS "Air Systems of Illinois, Inc." OXYGEN 99
L/100L
65133-130_e2cffd30-525d-4e50-9903-23031a345e56 65133-130 HUMAN OTC DRUG
Aire-Master Sanitizer Gel vit e/a Alcohol GEL TOPICAL 19980101
OTC MONOGRAPH NOT FINAL part333E "Aire-Master of America, Inc" ALCOHOL
60 mL/100mL
65133-110_00cd7242-44f3-45d5-98d6-faa2a57145bb 65133-110 HUMAN OTC DRUG
Aire-Master Alcohol GEL TOPICAL 19980101 OTC MONO
GRAPH NOT FINAL part333E "Aire-Master of America, Inc." ALCOHOL 60
mL/100mL
65133-120_c6b88516-3eac-4439-9d0a-2c1a071832dc 65133-120 HUMAN OTC DRUG
mL/100mL
65133-140_1a02eda6-798b-435d-84d3-bd64a8021e0f 65133-140 HUMAN OTC DRUG
mL/100mL
65133-150_c825bcc7-a25b-4b3c-a0ac-d07b49e8d4a7 65133-150 HUMAN OTC DRUG
Aire-Master Alcohol LIQUID TOPICAL 20060101 OTC MONO
mL/100mL
65133-160_a4ef7848-fffa-40c8-9bb3-113a323d9c8e 65133-160 HUMAN OTC DRUG
Aire-Master Liquid spray handsanitizer LIQUID TOPICAL 20120507
OTC MONOGRAPH NOT FINAL part333E "Aire-Master of America, Inc." ALCOHOL
62 mL/100mL
63917-001_06c65b8d-2b1d-414f-af88-cee1ae547a03 63917-001 HUMAN PRESCRIPTI
20091229 NDA NDA205846 "Airgas Carbonic, Inc." CARBON D
IOXIDE 1000 mL/L "Radiographic Contrast Agent [EPC],X-Ray Contrast Activi
ty [MoA]"
25543-100_c3b78044-b414-436e-8f46-cc0f35466a24 25543-100 HUMAN PRESCRIPTI
ON DRUG "Oxygen, Refrigerated Liquid" "Oxygen, Refrigerated Liquid"
AL GAS AirGas East OXYGEN 1 L/L
25543-200_5155ec69-d6e8-411e-a385-c6e0c69775bd 25543-200 HUMAN PRESCRIPTI
ON DRUG Tri-Med Medical Compressed Oxygen GAS RESPIRATORY (INH
ALATION) 20100422 UNAPPROVED MEDICAL GAS AirGas E
ast OXYGEN 1 L/L
25543-001_0f728cea-adcf-4551-83c5-3d9a135d806c 25543-001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS "Airgas East, Inc." OXYGEN 995 mL/L
25543-004_10690114-2bf9-4ef5-ad9c-c485b58f974c 25543-004 HUMAN PRESCRIPTI
19910122 UNAPPROVED MEDICAL GAS "Airgas East, Inc."
t Activity [MoA]"
25543-005_ef46c79e-1c19-4904-a310-30c085c4b7fc 25543-005 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS "Airgas East, Inc." AIR 1000 mL/L
25543-011_e310afbc-50fa-4883-921e-792b38c6c391 25543-011 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS "Airgas East, Inc." HELIUM 999 mL/L
25543-012_1e8dfa9a-3cc1-4cbe-84c4-12ad149b2027 25543-012 HUMAN PRESCRIPTI
19910115 UNAPPROVED MEDICAL GAS "Airgas East, Inc."
58420-001_6d5083ee-2a43-4388-afb0-ae7bc37ef146 58420-001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS Airgas Intermountain Inc OXYGEN 992
mL/L
58420-002_5d1f77ff-b355-4463-9f8b-a75bdb6b4d93 58420-002 HUMAN PRESCRIPTI
19750101 UNAPPROVED MEDICAL GAS Airgas Intermountain Inc
NITROGEN 992 mL/L
58420-003_275e87da-a1ba-4e2f-8dd7-0cf598db21ee 58420-003 HUMAN PRESCRIPTI
58420-004_17eaf086-da43-45a9-96f7-4963599d8041 58420-004 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS Airgas Intermountain Inc HELIUM 992
mL/L
58420-005_eb13cea1-3db6-4606-80ee-bbbea7f570dd 58420-005 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS Airgas Intermountain Inc AIR 1000
mL/L
58420-006_831a4542-6a79-419b-b286-2d8362e52d46 58420-006 HUMAN PRESCRIPTI
t Activity [MoA]"
58420-007_3d051449-4685-42c2-b8d1-fa928c82d55c 58420-007 HUMAN PRESCRIPTI
Airgas Intermountain Inc HELIUM; OXYGEN 800; 200 mL/L; mL/L
58420-009_6ebe9ecb-fa0c-44ef-847d-11365dc23c26 58420-009 HUMAN PRESCRIPTI
AL GAS Airgas Intermountain Inc CARBON DIOXIDE; OXYGEN 300; 700
mL/L; mL/L "Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA]
"
33237-001_0c72f6c3-354c-4fc8-bcd8-d9edd7e7d8a5 33237-001 HUMAN PRESCRIPTI
NDA NDA205840 "Airgas Merchant Gases, LLC" OXYGEN 990 mL/L
33237-002_a006196e-64ad-4a31-be4e-38882257ce96 33237-002 HUMAN PRESCRIPTI
20070401 NDA NDA205839 "Airgas Merchant Gases, LLC"
NITROGEN 990 mL/L
11896-0017_b1216615-78a2-4377-add6-957fd7c781cc 11896-0017 HUMAN PRESCRIPTI
ON DRUG Helium Oxygen Helium Oxygen GAS RESPIRATORY (INHALATION)
19640101 UNAPPROVED MEDICAL GAS Airgas National Welders
HELIUM; OXYGEN 800; 200 mL/L; min/L
11896-0018_51e6cf36-97ae-4d17-9372-5a3947c2e0bb 11896-0018 HUMAN PRESCRIPTI
HELIUM; OXYGEN 700; 300 mL/L; mL/L
11896-0019_e0ed0937-63ba-409e-a194-6b45ebef5ed6 11896-0019 HUMAN PRESCRIPTI
HELIUM; OXYGEN 600; 400 mL/L; mL/L
57472-001_2f95294f-4a96-48c1-b62a-3abf4e6be739 57472-001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS AIRGAS NOR PAC INC OXYGEN 995 mL/L
57472-002_5bf03867-b1da-4bce-95fa-c63c871a255c 57472-002 HUMAN PRESCRIPTI
19830101 UNAPPROVED MEDICAL GAS AIRGAS NOR PAC INC
NITROGEN 995 mL/L
57472-003_7881d7c9-ebea-4092-8b21-38d2b823ad17 57472-003 HUMAN PRESCRIPTI
57472-004_6fdd4b14-a689-45c7-9c68-848483abc227 57472-004 HUMAN PRESCRIPTI
t Activity [MoA]"
58789-001_62291510-9dec-4804-ae5b-c94f4cb227f5 58789-001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS "Airgas Northern California and Nevada, Inc."
OXYGEN 992 mL/L
58789-002_11bc9e36-54fc-49ed-9474-2cbc639c5628 58789-002 HUMAN PRESCRIPTI
19650101 UNAPPROVED MEDICAL GAS "Airgas Northern Califor
nia and Nevada, Inc." NITROGEN 992 mL/L
58789-003_8ff0d4f1-9da8-47ae-8325-d76240146ceb 58789-003 HUMAN PRESCRIPTI
nia and Nevada, Inc." CARBON DIOXIDE 992 mL/L "Radiographic Contrast A
gent [EPC],X-Ray Contrast Activity [MoA]"
58789-005_6869fd3c-cdaa-4626-a9cd-f8427c76011a 58789-005 HUMAN PRESCRIPTI
HELIUM 999 mL/L
58789-006_ff7d204f-2c35-42b1-a264-4209c27fdcf5 58789-006 HUMAN PRESCRIPTI
nia and Nevada, Inc." NITROUS OXIDE 992 mL/L
58789-500_9b8e952f-7f55-43c7-944d-581de60cd875 58789-500 HUMAN PRESCRIPTI
AIR 1000 mL/L
11390-001_bc2499ca-7665-4592-9459-87f56409cadc 11390-001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS "Airgas Southwest, Inc." OXYGEN 990
mL/L
11390-004_9e57550d-2c9a-42fb-a276-a8580f6a5a00 11390-004 HUMAN PRESCRIPTI
20000720 UNAPPROVED MEDICAL GAS "Airgas Southwest, Inc."
t Activity [MoA]"
11390-025_538fb9e2-2932-401f-bfd1-f870d16f5042 11390-025 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS "Airgas Southwest, Inc." AIR 1000
mL/L
67989-011_54e8282d-592d-4a21-ab01-2da34170792e 67989-011 HUMAN PRESCRIPTI
ON DRUG Nitric Oxide Nitrogen Mix Nitric Oxide Nitrogen Mix
AL GAS Airgas Specialty Gases NITRIC OXIDE; NITROGEN 5; 955 mL/L; mL
/L "Vasodilation [PE],Vasodilator [EPC]"
11054-010_7bb46612-5cab-436e-bfe4-0ac92aedd893 11054-010 HUMAN PRESCRIPTI
ON DRUG "Oxygen, Refrigerated" "Oxygen, Refrigerated" GAS RESPIRAT
"AIRGAS USA, LLC" OXYGEN 992 mL/L
57472-005_8852cad5-9e11-4bf0-8986-037792f57539 57472-005 HUMAN PRESCRIPTI
ON DRUG Carbon Dioxide Oxygen Mix Carbon Dioxide Oxygen Mix
AL GAS AIRGAS-NORPAC INC. CARBON DIOXIDE; OXYGEN 200; 800
mL/L; mL/L "Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA]
"
57472-006_903f6c44-2f78-42ad-a79f-230bb3b578b6 57472-006 HUMAN PRESCRIPTI
ON DRUG AIR AIR GAS RESPIRATORY (INHALATION) 19830101
UNAPPROVED MEDICAL GAS AIRGAS-NORPAC INC. AIR 1000 mL/L
57472-007_7a83fc9c-ae0c-430a-bdf6-443d1370df88 57472-007 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS AIRGAS-NORPAC INC. HELIUM 995 mL/L
10678-001_87f75b7d-93c7-4f9d-b04b-12505e417a6f 10678-001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS "Airgas-West, Inc." OXYGEN 992 mL/L
10678-002_110133ca-2e25-4873-a5fe-beaa53a0d166 10678-002 HUMAN PRESCRIPTI
19470523 UNAPPROVED MEDICAL GAS "Airgas-West, Inc."
NITROGEN 992 mL/L
10678-003_a417c555-9f9a-4ba5-8b0d-87c680fc41e2 10678-003 HUMAN PRESCRIPTI
t Activity [MoA]"
10678-004_30a834fa-7c4e-4b5c-9035-523b42035056 10678-004 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS "Airgas-West, Inc." HELIUM 992 mL/L
10678-005_04f969ab-32bb-4599-b58d-a03c232f2a89 10678-005 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS "Airgas-West, Inc." AIR 1000 mL/L
10678-006_9e4d7ac2-5a05-47ee-9349-87431e028eeb 10678-006 HUMAN PRESCRIPTI
10678-007_1908fe5a-36f1-4ce3-a458-90154a81025c 10678-007 HUMAN PRESCRIPTI
ON DRUG Helium Oxygen Mix Helium Oxygen Mix GAS RESPIRAT
"Airgas-West, Inc." HELIUM; OXYGEN 600; 400 mL/L; mL/L
10678-008_27ec7dff-f916-46fe-97bd-76e007305446 10678-008 HUMAN PRESCRIPTI
ON DRUG Oxygen Carbon Dioxide Mix Oxygen Carbon Dioxide Mix
AL GAS "Airgas-West, Inc." CARBON DIOXIDE; OXYGEN 50; 950 mL/L; mL
/L "Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA]"
10678-010_e8e2d396-66f6-4ff2-8601-733753b23a42 10678-010 HUMAN PRESCRIPTI
ON DRUG Helium Oxygen Mix 70/30 Helium Oxygen Mix 70/30 GAS RESPIRAT
10678-011_1155add9-7528-4250-9580-11c42d0c7a2e 10678-011 HUMAN PRESCRIPTI
ON DRUG Helium Oxygen Mix 80/20 Helium Oxygen Mix 80/20 GAS RESPIRAT
10358-1417_20df91c8-0e11-465a-b810-0e7a5c9a2785 10358-1417 HUMAN PRESCRIPTI
ON DRUG OXYGEN OXYGEN GAS NASAL; RESPIRATORY (INHALATION) 20040818
UNAPPROVED MEDICAL GAS AIRSENSE INC OXYGEN 995 mL/L
67711-001_4c90f372-42df-4146-a11a-55c41da7acda 67711-001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS "AIRSERVE, LLC" OXYGEN 991 mL/L
54483-0001_29c43bba-5511-495a-a108-6603acddcf61 54483-0001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS "Air-Way Medical, Inc." OXYGEN 99 L/100L
59714-101_db07db3e-3bb8-4dc8-b608-8de5bd2a74c5 59714-101 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS AIRWAY OXYGEN INC OXYGEN 99 L/100L
48599-345_4a180193-c181-4c86-bb96-9f75491cacb6 48599-345 HUMAN PRESCRIPTI
ON DRUG OXYGEN OXYGEN GAS NASAL 19650101 UNAPPROV
ED MEDICAL GAS "Airweld, Inc." OXYGEN 99 L/100L
50522-221_c7bf6427-61e9-4fec-b121-e23071010409 50522-221 HUMAN OTC DRUG
Sani ALCOHOL GEL TOPICAL 20120524 OTC MONOGRAPH NO
T FINAL part333E "AIS Specialty Products, Inc." ALCOHOL 0.7 mL/mL
27241-001_a8493817-f188-4ed0-95b7-87c81c0ae3af 27241-001 HUMAN PRESCRIPTI
ON DRUG RISPERIDONE RISPERIDONE TABLET ORAL 20140423
ANDA ANDA201003 Ajanta Pharma Limited RISPERIDONE 1 mg/1
Atypical Antipsychotic [EPC]
ANDA ANDA201003 Ajanta Pharma Limited RISPERIDONE 0.25 mg/1
ANDA ANDA201003 Ajanta Pharma Limited RISPERIDONE 0.5 mg/1
42787-101_45375d2d-b519-4e3c-800e-b3eefa0e6857 42787-101 HUMAN OTC DRUG
Value Pharma Aspirin Pain Reliever Aspirin TABLET ORAL 20121001
OTC MONOGRAPH FINAL part343 "Ajes Pharmaceuticals,LLC" ASPIRIN 81
mg/81mg
42787-101_83ab9ae9-51ce-4763-a39a-03585c908116 42787-101 HUMAN OTC DRUG
Value Pharma Aspirin Pain Reliever Aspirin TABLET ORAL 20121001
mg/81mg
42787-102_615db3ad-3529-4e96-962a-96324d2c5c97 42787-102 HUMAN OTC DRUG
Value PharmaPain Reliever Extra Strength Aspirin TABLET ORAL 20121001
mg/325mg
42787-102_893f4de2-d639-4e24-9c95-741b3f90a25e 42787-102 HUMAN OTC DRUG
Value PharmaPain Reliever Extra Strength Aspirin TABLET ORAL 20121001
mg/325mg
42787-104_33e8167f-3d6f-42eb-be0e-abe2dcb25f5d 42787-104 HUMAN OTC DRUG
BENALDRYL DIPHENHYDRAMINE HCL TABLET ORAL 20120901
OTC MONOGRAPH NOT FINAL part348 "AJES PHARMACEUTICALS,LLC" DIPHENHYDRAMINE
HYDROCHLORIDE 25 mg/250mg
42787-104_6854488c-af16-4d30-9a24-bcf3aafac41e 42787-104 HUMAN OTC DRUG
BENALDRYL DIPHENHYDRAMINE HCL TABLET ORAL 20120901
OTC MONOGRAPH NOT FINAL part348 "AJES PHARMACEUTICALS,LLC" DIPHENHYDRAMINE
HYDROCHLORIDE 25 mg/250mg
42787-105_6558ce50-cba7-464e-9cad-a0206629c2ef 42787-105 HUMAN OTC DRUG
SENOKOT-S Docuset Sodium PILL ORAL 20120901
OTC MONOGRAPH NOT FINAL part334 "Ajes Pharmaceuticals,LLC" DOCUSATE SODIUM;
SENNOSIDES 50; 8.6 mg/340mg; mg/340mg
76340-1001_8bf094ed-d730-445e-a5ae-8c65ac55ec9b 76340-1001 HUMAN OTC DRUG
YS Solution Ac control Skin Regular Mild salicylic acid LIQUID
TOPICAL 20110810 UNAPPROVED DRUG OTHER "Ajou Medics Co.
, Ltd" SALICYLIC ACID 0.47 mL/100mL
76340-1101_e331d4c1-599f-4c21-8a10-e5d7626425af 76340-1101 HUMAN OTC DRUG
YS Solution Intensive AC Care salicylic acid GEL TOPICAL 20110810
UNAPPROVED DRUG OTHER "Ajou Medics Co., Ltd" SALICYLIC ACID 0.47
mL/100mL
76340-1201_9a44ef62-8e9c-4417-8747-6daef042424a 76340-1201 HUMAN OTC DRUG
Dr. Eslee Physical Sunscreen Zinc oxide CREAM TOPICAL 20130628
OTC MONOGRAPH FINAL part347 "Ajou Medics Co., Ltd" ZINC OXIDE 0.01248
g/g
76340-1301_08fa2bfb-cfb9-4b85-bbc5-e850ddfdb5ac 76340-1301 HUMAN OTC DRUG
Dr.eslee Intensive Recovery Blemish Balm Zinc oxide CREAM
TOPICAL 20140723 OTC MONOGRAPH FINAL part347 "Ajou Medics Co.
, Ltd" ZINC OXIDE 0.01248 g/g
76340-2001_1fa11bd2-9f9e-4f2f-9046-615f8db02a0f 76340-2001 HUMAN OTC DRUG
YS Solution Ac Care salicylic acid CREAM TOPICAL 20110810
mL/100mL
76340-3001_0b744657-b585-4a20-927a-d5a88a11f12b 76340-3001 HUMAN OTC DRUG
Dr.eslee Sun Matte OCTINOXATE LIQUID TOPICAL 20110810
UNAPPROVED DRUG OTHER "Ajou Medics Co., Ltd" OCTINOXATE 7.5
g/100g
76340-4001_8193343f-408d-41ac-80b1-e3ceca18c791 76340-4001 HUMAN OTC DRUG
Dr.eslee Sun Protection OCTINOXATE CREAM TOPICAL 20110810
UNAPPROVED DRUG OTHER "Ajou Medics Co., Ltd" OCTINOXATE 7
g/100g
76340-5001_a9970e98-7bad-4f2e-b25f-0f60ca838dcb 76340-5001 HUMAN OTC DRUG
Dr.eslee Skin Mild salicylic acid LIQUID TOPICAL 20110810
mL/100mL
76340-6001_93559658-a3bb-4b6b-9aa6-3aee6f8690ad 76340-6001 HUMAN OTC DRUG
Dr.eslee Triple Action BB ADENOSINE CREAM TOPICAL 20110913
UNAPPROVED DRUG OTHER "Ajou Medics Co., Ltd" ADENOSINE 0.2
g/100g
76340-7001_943d8c5d-db3a-4a7c-9182-f930594d0959 76340-7001 HUMAN OTC DRUG
Bellaskin Brightening Contour Essence NIACINAMIDE CREAM TOPICAL
20110913 UNAPPROVED DRUG OTHER "Ajou Medics Co., Ltd"
NIACINAMIDE 2 mL/100mL
76340-8001_aea72323-c81e-44db-847b-96e6b3948ed2 76340-8001 HUMAN OTC DRUG
Bellaskin Skin-rebirth Contour ADENOSINE CREAM TOPICAL 20110913
UNAPPROVED DRUG OTHER "Ajou Medics Co., Ltd" ADENOSINE 0.04
mL/100mL
76340-9001_9bf31400-7baf-46b0-afb8-434c8289a396 76340-9001 HUMAN OTC DRUG
YS Solution Ac control Skin Regular Mild salicylic acid LIQUID
TOPICAL 20111025 UNAPPROVED DRUG OTHER "Ajou Medics Co.
, Ltd" SALICYLIC ACID 0.47 mL/100mL
62111-0210_7882cc7e-d04e-4565-8366-b1ebf167aed8 62111-0210 HUMAN OTC DRUG
LIP ENHANCER GLOSS SUNSCREEN BROAD SPECTRUM SPF15 "AVOBENZONE, OCT
INOXATE, OCTISALATE" GEL TOPICAL 20140206 OTC MONOGRAPH NO
T FINAL part352 AKG Innovations LLC AVOBENZONE; OCTINOXATE; OCTISALATE
62111-0211_0266a461-597c-4ad7-999c-9e070c2e063f 62111-0211 HUMAN OTC DRUG
Moisturizing Lip BalmSPF30 "AVOBENZONE, HOMOSALATE, OCTISALATE, OCT
OCRYLENE, OXYBENZONE" STICK TOPICAL 20140206 OTC MONOGRAPH NO
T FINAL part352 AKG Innovations LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTO
CRYLENE; OXYBENZONE 25; 80; 50; 22; 30 mg/g; mg/g; mg/g; mg/g; mg/g
62111-0212_31539b3c-ad6e-4c7f-b464-2c5ed6daa711 62111-0212 HUMAN OTC DRUG
PROFESSIONAL WHITENING SYSTEM WHITENING MOUTH WASH Sodium Fluoride
MOUTHWASH ORAL 20140214 OTC MONOGRAPH FINAL part355
AKG Innovations LLC SODIUM FLUORIDE 0.2 mg/mL
62111-0213_7a426e80-7e89-4f1e-8c92-0c6c09abd0ac 62111-0213 HUMAN OTC DRUG
PROFESSIONAL WHITENING SYSTEM WHITENING SODIUM FLUORIDE PASTE DENTAL
20140214 OTC MONOGRAPH FINAL part355 AKG Innovations LLC
SODIUM FLUORIDE 0.23 g/100g
17478-067_5a801d7f-566f-4c16-ae95-55cc2ed81e72 17478-067 HUMAN PRESCRIPTI
ON DRUG Alfenta Alfentanil hydrochloride INJECTION INTRAVEN
OUS 20100201 NDA NDA019353 Akorn ALFENTANIL HYDRO
CHLORIDE 500 ug/mL "Full Opioid Agonists [MoA],Opioid Agonist [EPC]
" CII
17478-080_2b14f1a3-f8d6-45e8-a31a-89dc25d5c7f8 17478-080 HUMAN PRESCRIPTI
ON DRUG CAPASTAT SULFATE Capreomycin "INJECTION, POWDER, FOR
SOLUTION" INTRAMUSCULAR; INTRAVENOUS 20090801 NDA
NDA050095 Akorn CAPREOMYCIN SULFATE 1 g/1 Antimycobacteria
l [EPC]
17478-207_48c2e2b9-4b7c-488a-a658-6a3097829e42 17478-207 HUMAN PRESCRIPTI
ON DRUG Ketorolac Tromethamine Ketorolac Tromethamine SOLUTION/ DROPS
OPHTHALMIC 20140210 ANDA ANDA203376 Akorn KETOROLA
C TROMETHAMINE 4.5 mg/mL "Cyclooxygenase Inhibitors [MoA],Nonsteroidal An
rug [EPC]"
17478-250_926997f2-7be9-4626-bdef-73a90f09194b 17478-250 HUMAN PRESCRIPTI
ON DRUG AK-FLUOR fluorescein sodium INJECTION INTRAVEN
OUS 20081001 NDA NDA022186 Akorn FLUORESCEIN SODI
UM 250 mg/mL "Diagnostic Dye [EPC],Dyes [MoA]"
17478-253_926997f2-7be9-4626-bdef-73a90f09194b 17478-253 HUMAN PRESCRIPTI
ON DRUG AK-FLUOR fluorescein sodium INJECTION INTRAVEN
OUS 20081001 NDA NDA022186 Akorn FLUORESCEIN SODI
UM 100 mg/mL "Diagnostic Dye [EPC],Dyes [MoA]"
17478-327_1f578c39-5da1-4cd6-9a50-0ef437151c45 17478-327 HUMAN PRESCRIPTI
ON DRUG Zoledronic Acid Zoledronic Acid "INJECTION, SOLUTION, CONCENTRAT
E" INTRAVENOUS 20140522 ANDA ANDA202548 Akorn
ZOLEDRONIC ACID 4 mg/5mL "Bisphosphonate [EPC],Diphosphonates [Chemical/I
ngredient]"
17478-510_11695f58-c5a9-424d-954d-086275b40291 17478-510 HUMAN PRESCRIPTI
ON DRUG Physostigmine Salicylate Physostigmine Salicylate
INJECTION INTRAVENOUS 20100810 UNAPPROVED DRUG OTHER
Akorn PHYSOSTIGMINE SALICYLATE 1 mg/mL
17478-605_8a0155ee-4593-42aa-88ea-2971a3c14e20 17478-605 HUMAN PRESCRIPTI
ON DRUG COSOPT Dorzolamide Hydrochloride and Timolol Maleate SOLUTION
/ DROPS OPHTHALMIC 20140430 NDA NDA020869 Akorn
DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE 20; 5 mg/mL; mg/mL "Carboni
c Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Adrenergic beta-
Antagonists [MoA],beta-Adrenergic Blocker [EPC]"
17478-933_452dcbc2-05fd-4ede-bb1b-be661eb85b31 17478-933 HUMAN PRESCRIPTI
ON DRUG Terbutaline Sulfate Terbutaline Sulfate INJECTION
SUBCUTANEOUS 20100201 ANDA ANDA078151 Akorn TERBUTAL
INE SULFATE 1 mg/mL
23360-151_7c65f43a-d202-4bcb-b582-9a667c395be0 23360-151 HUMAN PRESCRIPTI
ON DRUG Sterile Vancomycin Hydrochloride Vancomycin Hydrochloride
ANDA ANDA065397 Akorn - Strides LLC VANCOMYCIN HYDROCHLORIDE
500 mg/10mL "Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingred
ient]"
23360-152_7c65f43a-d202-4bcb-b582-9a667c395be0 23360-152 HUMAN PRESCRIPTI
ON DRUG Sterile Vancomycin Hydrochloride Vancomycin Hydrochloride
1 g/20mL "Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingred
ient]"
23360-153_10fb3ba8-d5ed-4efb-a4fb-62c1fb317a40 23360-153 HUMAN PRESCRIPTI
ON DRUG STERILE VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride
ient]"
23360-160_dd793afb-bc0c-4f56-a925-238e139155c3 23360-160 HUMAN PRESCRIPTI
ON DRUG Vecuronium bromide Vecuronium bromide "INJECTION, POWD
ANDA090243 Akorn - Strides LLC VECURONIUM BROMIDE 1 mg/mL
"Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Block
er [EPC]"
17478-106_b18b5d2a-15c7-4701-8c5c-bee2fe1a18d1 17478-106 HUMAN PRESCRIPTI
ON DRUG Levofloxacin Levofloxacin SOLUTION OPHTHALMIC
20110301 ANDA ANDA090268 Akorn Inc. LEVOFLOXACIN
5 mg/mL "Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]"
17478-151_1881d0ef-38d3-4ecc-bd51-d20679b7dc2f 17478-151 HUMAN PRESCRIPTI
ON DRUG Rifampin Rifampin "INJECTION, POWDER, LYOPHILIZED,
AKORN INC. RIFAMPIN 600 mg/10mL "Rifamycin Antibacterial [EPC],R
ifamycins [Chemical/Ingredient]"
17478-208_4ee442f9-8d8f-49e2-9b2c-9369a3868585 17478-208 HUMAN PRESCRIPTI
ON DRUG Ketorolac Tromethamine Ketorolac Tromethamine SOLUTION
OPHTHALMIC 20091105 ANDA ANDA078399 Akorn Inc.
KETOROLAC TROMETHAMINE 4 mg/mL "Cyclooxygenase Inhibitors [MoA],Nonster
matory Drug [EPC]"
17478-209_dee6bdbf-4e0f-425c-8f66-6baccf6f6be4 17478-209 HUMAN PRESCRIPTI
ON DRUG Ketorolac Tromethamine ketorolac tromethamine SOLUTION
matory Drug [EPC]"
17478-546_03be5cb5-03e7-4ae1-9857-36178e37fb36 17478-546 HUMAN PRESCRIPTI
ON DRUG Granisetron Hydrochloride Granisetron Hydrochloride
INJECTION INTRAVENOUS 20091001 ANDA ANDA079078
Akorn Inc. GRANISETRON HYDROCHLORIDE 1 mg/mL "Serotonin 3 Rec
eptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]"
17478-547_03be5cb5-03e7-4ae1-9857-36178e37fb36 17478-547 HUMAN PRESCRIPTI
Akorn Inc. GRANISETRON HYDROCHLORIDE 0.1 mg/mL "Serotonin 3 Rec
17478-714_87180bd3-1c89-4583-aae3-956fac82c907 17478-714 HUMAN PRESCRIPTI
ON DRUG Ciprofloxacin Ciprofloxacin Hydrochloride SOLUTION/ DROPS
CIPROFLOXACIN HYDROCHLORIDE 3 mg/mL "Quinolone Antimicrobial [EPC],Q
uinolones [Chemical/Ingredient]"
17478-716_aa34a505-eb81-4a9b-9679-57b34d249bcd 17478-716 HUMAN PRESCRIPTI
ON DRUG Apraclonidine Ophthalmic Apraclonidine Hydrochloride
SOLUTION/ DROPS OPHTHALMIC 20090812 ANDA ANDA077764
Akorn Inc. APRACLONIDINE HYDROCHLORIDE 5 mg/mL "Adrenergic alph
a-Agonists [MoA],alpha-Adrenergic Agonist [EPC]"
17478-010_8496ebbf-5ea5-46de-b4a5-74d334d77ba7 17478-010 HUMAN PRESCRIPTI
ON DRUG Inapsine Droperidol INJECTION INTRAMUSCULAR; I
NTRAVENOUS 19960701 NDA NDA016796 "Akorn, Inc."
DROPERIDOL 2.5 mg/mL "Dopamine D2 Antagonists [MoA],Dopamine-2 Recept
or Antagonist [EPC]"
17478-012_6e1fda58-f044-45d1-a74a-fbf8e88f7c73 17478-012 HUMAN PRESCRIPTI
ON DRUG Benztropine Mesylate Benztropine Mesylate INJECTION
INTRAMUSCULAR; INTRAVENOUS 20120808 NDA AUTHORIZED GENERIC
NDA012015 "Akorn, Inc." BENZTROPINE MESYLATE 1 mg/mL "Anticho
linergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Recep
tor Antagonists [MoA]"
17478-030_5a4b84d2-0743-4974-9982-7c114d2af4e9 17478-030 HUMAN PRESCRIPTI
ON DRUG FENTANYL CITRATE FENTANYL CITRATE INJECTION
INTRAMUSCULAR; INTRAVENOUS 20120322 NDA NDA016619
"Akorn, Inc." FENTANYL CITRATE 50 ug/mL "Full Opioid Agonists [M
17478-040_f9668769-29c4-4486-833f-c3e210b96f1e 17478-040 HUMAN PRESCRIPTI
ON DRUG Lorazepam Lorazepam INJECTION INTRAMUSCULAR
19800701 ANDA ANDA075025 "Akorn, Inc." LORAZEPAM
2 mg/mL "Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]"
CIV
17478-045_ee2a9b04-7c88-4c8d-8a55-d8ca73e03b59 17478-045 HUMAN PRESCRIPTI
ON DRUG Tetracaine Tetracaine HCl INJECTION SUBARACHNOID
20100601 UNAPPROVED DRUG OTHER "Akorn, Inc." TETRACAI
NE HYDROCHLORIDE 10 mg/mL "Ester Local Anesthetic [EPC],Esters [Ch
emical/Ingredient],Local Anesthesia [PE]"
17478-050_2a04386e-0c3d-4ece-be52-9bacf649ded4 17478-050 HUMAN PRESCRIPTI
ON DRUG Sufentanil Citrate Sufentanil Citrate INJECTION
EPIDURAL; INTRAVENOUS 20101201 NDA NDA019050 "Akorn,
Inc." SUFENTANIL CITRATE 50 ug/mL "Full Opioid Agonists [MoA],Opio
17478-060_bdc9fa91-6413-4920-a6dd-f6e089788370 17478-060 HUMAN OTC DRUG
Artificial Tears Polyvinyl Alcohol SOLUTION/ DROPS OPHTHALM
IC 19980301 OTC MONOGRAPH FINAL part349 "Akorn, Inc."
POLYVINYL ALCOHOL 14 mg/mL
17478-062_a8145a3b-1d31-4069-974a-c81998336cb1 17478-062 HUMAN OTC DRUG
Artificial Tears Mineral Oil and Petrolatum OINTMENT
OPHTHALMIC 19900901 OTC MONOGRAPH FINAL part349 "Akorn,
Inc." MINERAL OIL; PETROLATUM 150; 830 mg/g; mg/g
17478-063_1b32e063-96e1-489b-9638-466ea56afc63 17478-063 HUMAN OTC DRUG
Lubricant Eye Mineral Oil and Petrolatum OINTMENT OPHTHALM
IC 19930401 OTC MONOGRAPH FINAL part349 "Akorn, Inc."
MINERAL OIL; PETROLATUM 120; 880 mg/g; mg/g
17478-064_0bf13d29-b5ce-4a34-a6a5-4883a13487b1 17478-064 HUMAN PRESCRIPTI
ON DRUG Gonak Hypromellose Hypromellose 2906 (4000 MPA.S) and Hypro
mellose 2906 (50 MPA.S) SOLUTION OPHTHALMIC 19970101
UNAPPROVED DRUG OTHER "Akorn, Inc." HYPROMELLOSE 2906 (4000 MPA.S);
HYPROMELLOSE 2906 (50 MPA.S) 25; 25 mg/mL; mg/mL
17478-065_d13209d6-46d4-41b7-9fc6-4c2bbc8882dd 17478-065 HUMAN OTC DRUG
Naphazoline Hydrochloride and Pheniramine Maleate Naphazoline Hydr
ochloride and Pheniramine Maleate SOLUTION/ DROPS OPHTHALMIC 20130124
ANDA ANDA202795 "Akorn, Inc." NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE M
ALEATE .25; 3 mg/mL; mg/mL
17478-066_9496f818-72c7-400f-a6ee-77c851f0d320 17478-066 HUMAN PRESCRIPTI
ON DRUG Nedocromil Sodium Nedocromil Sodium SOLUTION/ DROPS
OPHTHALMIC 20120910 ANDA ANDA090638 "Akorn, Inc."
NEDOCROMIL SODIUM 20 mg/mL "Decreased Histamine Release [PE],Mast C
ell Stabilizer [EPC]"
17478-069_32922883-4490-4c2f-b0df-8738dc748eb1 17478-069 HUMAN PRESCRIPTI
ON DRUG PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM "INJECTION, POWD
97 "Akorn, Inc." PANTOPRAZOLE SODIUM 40 mg/1 "Proton Pump Inh
ibitor [EPC],Proton Pump Inhibitors [MoA]"
17478-070_8003f107-a779-4404-9ca4-cb37ec13e81f 17478-070 HUMAN PRESCRIPTI
ON DRUG Erythromycin Erythromycin OINTMENT OPHTHALMIC
19960718 ANDA ANDA064030 "Akorn, Inc." ERYTHROMYCIN
5 mg/g "Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macroli
de Antimicrobial [EPC],Macrolides [Chemical/Ingredient]"
17478-097_09161d72-515d-4ab3-9eca-7f492cc37fd1 17478-097 HUMAN PRESCRIPTI
ON DRUG Cyclopentolate Hydrochloride Cyclopentolate Hydrochloride
"Akorn, Inc." CYCLOPENTOLATE HYDROCHLORIDE 20 mg/mL
17478-100_09161d72-515d-4ab3-9eca-7f492cc37fd1 17478-100 HUMAN PRESCRIPTI
"Akorn, Inc." CYCLOPENTOLATE HYDROCHLORIDE 10 mg/mL
17478-101_00d4ae88-8439-46b6-9935-5fb3fa5213fa 17478-101 HUMAN PRESCRIPTI
ON DRUG Tropicamide Tropicamide SOLUTION/ DROPS OPHTHALMIC
20000929 ANDA ANDA040314 "Akorn, Inc." TROPICAMIDE
5 mg/mL "Anticholinergic [EPC],Cholinergic Antagonists [MoA]"
17478-102_00d4ae88-8439-46b6-9935-5fb3fa5213fa 17478-102 HUMAN PRESCRIPTI
20000929 ANDA ANDA040315 "Akorn, Inc." TROPICAMIDE
10 mg/mL "Anticholinergic [EPC],Cholinergic Antagonists [MoA]"
17478-107_cd20454b-b46c-43e8-85ea-4d96fe740d73 17478-107 HUMAN PRESCRIPTI
ON DRUG Levofloxacin Levofloxacin INJECTION INTRAVENOUS
20110701 ANDA ANDA091644 "Akorn, Inc." LEVOFLOXACIN
17478-120_4b58b993-b9e5-4a3f-88c2-8c1a084fa7fb 17478-120 HUMAN PRESCRIPTI
ON DRUG Clindamycin Clindamycin Phosphate INJECTION INTRAVEN
OUS 20130405 ANDA ANDA203048 "Akorn, Inc." CLINDAMY
CIN PHOSPHATE 300 mg/50mL "Decreased Sebaceous Gland Activity [PE],Lincosa
mide Antibacterial [EPC],Lincosamides [Chemical/Ingredient]"
17478-131_6d8a5748-ec3d-4a1b-a7b1-ce54ba397a30 17478-131 VACCINE Tetanus
and Diphtheria Toxoids Adsorbed Tetanus and Diphtheria Toxoids Adsorbed
INJECTION INTRAMUSCULAR 19700727 BLA BLA101322
"Akorn, Inc." CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CO
RYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 2; 2
[Lf]/.5mL; [Lf]/.5mL "Inactivated Clostridium Tetani Vaccine [EPC],Actively A
cquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Tetanus Toxoid
[Chemical/Ingredient],Inactivated Corynebacterium Diphtheriae Vaccine [EPC],Act
ively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Diphthe
ria Toxoid [Chemical/Ingredient]"
17478-190_a9c7e4e4-9728-42ee-a6d8-8b08cbba8975 17478-190 HUMAN PRESCRIPTI
ON DRUG Lidocaine and Prilocaine lidocaine and prilocaine
CREAM TOPICAL 20121112 NDA AUTHORIZED GENERIC NDA019941
"Akorn, Inc." LIDOCAINE; PRILOCAINE 25; 25 mg/g; mg/g "Amide Local Ane
[PE],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia
[PE]"
17478-200_1e9e91bc-17ef-4ceb-bc67-036dd5efc3f9 17478-200 HUMAN PRESCRIPTI
ON DRUG Phenylephrine Hydrochloride Phenylephrine Hydrochloride
SOLUTION/ DROPS OPHTHALMIC 19910701 UNAPPROVED DRUG OTHER
"Akorn, Inc." PHENYLEPHRINE HYDROCHLORIDE 25 mg/mL "alpha-1 Adrener
gic Agonist [EPC],Adrenergic alpha1-Agonists [MoA]"
17478-205_2a26ef2c-c715-415c-9258-f6bc267eb55f 17478-205 HUMAN PRESCRIPTI
"Akorn, Inc." PHENYLEPHRINE HYDROCHLORIDE 100 mg/mL "alpha-1 Adrener
17478-215_9a6b73d9-1e23-40e7-b80e-9b12e3e2a886 17478-215 HUMAN PRESCRIPTI
ON DRUG Atropine Atropine Sulfate SOLUTION/ DROPS OPHTHALM
IC 20140718 NDA NDA206289 "Akorn, Inc." ATROPINE
SULFATE 10 mg/mL "Anticholinergic [EPC],Cholinergic Antagonists [
MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists
[MoA]"
17478-216_70e961a5-5aab-4ce7-b564-b8c2a89da1d3 17478-216 HUMAN PRESCRIPTI
ON DRUG Naphazoline Naphazoline Hydrochloride SOLUTION/ DROPS
NAPHAZOLINE HYDROCHLORIDE 1 mg/mL
17478-235_4c70afb3-2cc3-4405-9a6e-06d444ebc2cb 17478-235 HUMAN PRESCRIPTI
ON DRUG "Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc"
"Neomycin Sulfate, Polymyxin B Sulfate and Bacitracin Zinc" OINTMENT
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 10000 [USP'U]/
g; mg/g; [USP'U]/g "Polymyxin-class Antibacterial [EPC],Polymyxins [Chemica
l/Ingredient],Decreased Cell Wall Synthesis & Repair [PE],Aminoglycoside Ant
ibacterial [EPC],Aminoglycosides [Chemical/Ingredient]"
17478-238_926a4b95-b197-400b-8e5d-e5e2ff4521cb 17478-238 HUMAN PRESCRIPTI
ON DRUG AK-POLY-BAC Bacitracin Zinc and Polymyxin B Sulfate OINTMENT
BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 10000 [USP'U]/g; [USP'U]/g
"Decreased Cell Wall Synthesis & Repair [PE],Polymyxin-class Antibacterial [
EPC],Polymyxins [Chemical/Ingredient]"
17478-263_61f6f83c-a75f-4eb2-a4f1-e274bbbff738 17478-263 HUMAN PRESCRIPTI
ON DRUG Proparacaine Hydrochloride Proparacaine Hydrochloride
"Akorn, Inc." PROPARACAINE HYDROCHLORIDE 5 mg/mL "Local Anesthesi
a [PE],Local Anesthetic [EPC]"
17478-283_e855bb7e-6d8d-40c0-907f-58b4406ccdc6 17478-283 HUMAN PRESCRIPTI
ON DRUG Gentamicin Sulfate Gentamicin Sulfate SOLUTION/ DROPS
GENTAMICIN SULFATE 3 mg/mL "Aminoglycoside Antibacterial [EPC],Amin
oglycosides [Chemical/Ingredient]"
17478-284_45bf825e-2e72-4033-b599-c884005d0504 17478-284 HUMAN PRESCRIPTI
ON DRUG Gentak Gentamicin Sulfate OINTMENT OPHTHALMIC
20060508 ANDA ANDA064093 "Akorn, Inc." GENTAMICIN SULFA
TE 3 mg/g "Aminoglycoside Antibacterial [EPC],Aminoglycosides [Che
mical/Ingredient]"
17478-288_b084dcbb-cd75-4c27-9966-e76353d9e463 17478-288 HUMAN PRESCRIPTI
ON DRUG Timolol Maleate Timolol Maleate SOLUTION/ DROPS OPHTHALMIC
20120326 ANDA ANDA074466 "Akorn, Inc." TIMOLOL MALEATE
5 mg/mL
17478-289_b084dcbb-cd75-4c27-9966-e76353d9e463 17478-289 HUMAN PRESCRIPTI
20120326 ANDA ANDA074465 "Akorn, Inc." TIMOLOL MALEATE
2.5 mg/mL
17478-290_b878b03f-20e2-4f63-bf8e-e91326fe2628 17478-290 HUMAN PRESCRIPTI
ON DRUG Tobramycin Tobramycin SOLUTION/ DROPS OPHTHALMIC
19960131 ANDA ANDA064096 "Akorn, Inc." TOBRAMYCIN
3 mg/mL "Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/In
gredient]"
17478-291_13348367-efd2-4e8c-bacb-9d61a0f48e0e 17478-291 HUMAN PRESCRIPTI
ON DRUG Cromolyn Sodium Cromolyn Sodium SOLUTION/ DROPS OPHTHALMIC
19980429 ANDA ANDA074706 "Akorn, Inc." CROMOLYN SODIUM
40 mg/mL "Decreased Histamine Release [PE],Mast Cell Stabilizer [EPC]"
17478-307_673a79b0-5743-4084-aa83-03af374ad4b0 17478-307 HUMAN PRESCRIPTI
ON DRUG AzaSITE Azithromycin Monohydrate SOLUTION/ DROPS OPHTHALM
IC 20140514 NDA NDA050810 "Akorn, Inc." AZITHROM
YCIN MONOHYDRATE 10 mg/mL "Macrolide Antimicrobial [EPC],Macrolide
17478-324_8f04e697-312f-4d6f-bc72-5f35467e3998 17478-324 HUMAN PRESCRIPTI
ON DRUG Zoledronic Acid Zoledronic Acid SOLUTION INTRAVENOUS
20140821 ANDA ANDA200918 "Akorn, Inc." ZOLEDRONIC ACID
5 mg/100mL "Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredien
t]"
17478-340_4d4ea03d-1759-4aef-999c-3447fa2c68f5 17478-340 HUMAN PRESCRIPTI
ON DRUG Tobramycin Tobramycin SOLUTION ORAL 20140529
ANDA ANDA201422 "Akorn, Inc." TOBRAMYCIN 300 mg/5mL "Aminogl
ycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient]"
17478-403_91f37154-901e-404f-9fb2-311bc4077fb5 17478-403 HUMAN PRESCRIPTI
ON DRUG FUL-GLO Fluorescein Sodium STRIP OPHTHALMIC 20040601
UNAPPROVED DRUG OTHER "Akorn, Inc." D&C YELLOW NO. 8 0.6
mg/1 "Diagnostic Dye [EPC],Dyes [MoA]"
17478-404_77814317-75f7-4b58-87e7-0fb7508b9b07 17478-404 HUMAN PRESCRIPTI
ON DRUG FUL-GLO Fluorescein Sodium STRIP OPHTHALMIC 20040601
UNAPPROVED DRUG OTHER "Akorn, Inc." D&C YELLOW NO. 8 1
mg/1 "Diagnostic Dye [EPC],Dyes [MoA]"
17478-419_8b346dfd-230e-4988-acf0-b460910ac138 17478-419 HUMAN PRESCRIPTI
ON DRUG Chlorothiazide Sodium Chlorothiazide Sodium INJECTION
INTRAVENOUS 20120813 NDA AUTHORIZED GENERIC NDA011145
"Akorn, Inc." CHLOROTHIAZIDE SODIUM 500 mg/1 "Increased Diuresis [PE]
,Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient]"
17478-420_518c0d94-2c2b-48ef-a13f-d019dfe82b04 17478-420 HUMAN PRESCRIPTI
ON DRUG Labetalol Hydrochloride Labetalol Hydrochloride "INJECTION, SOLU
TION" INTRAVENOUS 20040901 ANDA ANDA075431 "Akorn,
Inc." LABETALOL HYDROCHLORIDE 5 mg/mL "Adrenergic beta-Antagonists [Mo
A],beta-Adrenergic Blocker [EPC]"
17478-501_1ce0c87e-303b-4d45-ac12-bcd440c53eec 17478-501 HUMAN PRESCRIPTI
ON DRUG Methylergonovine Maleate methylergonovine maleate
"Akorn, Inc." METHYLERGONOVINE MALEATE 0.2 mg/mL "Ergolines [Chem
ical/Ingredient],Ergot Derivative [EPC]"
17478-503_8c1f5624-8da1-4aa6-b6a6-e94f8d410f8b 17478-503 HUMAN PRESCRIPTI
ON DRUG Dehydrated Alcohol Alcohol INJECTION INTRASPINAL
19970201 UNAPPROVED DRUG OTHER "Akorn, Inc." ALCOHOL
0.98 mL/mL
17478-504_508f682c-668e-4a65-b424-446136da03c8 17478-504 HUMAN PRESCRIPTI
ON DRUG Methylene Blue Methylene Blue INJECTION INTRAVENOUS
20090401 UNAPPROVED DRUG OTHER "Akorn, Inc." METHYLEN
E BLUE 10 mg/mL
17478-508_5eda2b95-18fc-4a7e-b9d8-52c8b83fad51 17478-508 HUMAN PRESCRIPTI
ON DRUG INDIGO CARMINE Indigotindisulfonate Sodium "INJECTION, SOLU
TION" INTRAMUSCULAR; INTRAVENOUS 20090401 UNAPPROVED DRUG
OTHER "Akorn, Inc." INDIGOTINDISULFONATE SODIUM 8 mg/mL
17478-515_c6d186e1-72f1-44e3-ae53-a45df5bf8f59 17478-515 HUMAN PRESCRIPTI
ON DRUG Ephedrine Sulfate Ephedrine Sulfate INJECTION
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20090401 UNAPPROV
ED DRUG OTHER "Akorn, Inc." EPHEDRINE SULFATE 50 mg/mL
17478-523_84113f67-b333-416d-b285-dd1c9632ef80 17478-523 HUMAN PRESCRIPTI
ON DRUG Midazolam Midazolam Hydrochloride INJECTION INTRAMUS
CULAR; INTRAVENOUS 20050506 ANDA ANDA075494 "Akorn,
Inc." MIDAZOLAM HYDROCHLORIDE 1 mg/mL "Benzodiazepine [EPC],Benzodiaze
17478-524_84113f67-b333-416d-b285-dd1c9632ef80 17478-524 HUMAN PRESCRIPTI
ON DRUG Midazolam Midazolam Hydrochloride INJECTION INTRAMUS
CULAR; INTRAVENOUS 20050506 ANDA ANDA075494 "Akorn,
Inc." MIDAZOLAM HYDROCHLORIDE 5 mg/mL "Benzodiazepine [EPC],Benzodiaze
17478-526_e8e27a51-37d9-41b5-b6a7-d42782e4bc28 17478-526 HUMAN PRESCRIPTI
ON DRUG BAL DIMERCAPROL INJECTION INTRAMUSCULAR 20120501
NDA NDA005939 "Akorn, Inc." DIMERCAPROL 100 mg/mL "Metal C
helating Activity [MoA],Metal Chelator [EPC]"
17478-531_8496ebbf-5ea5-46de-b4a5-74d334d77ba7 17478-531 HUMAN PRESCRIPTI
ON DRUG Inapsine Droperidol INJECTION INTRAMUSCULAR; I
NTRAVENOUS 19960701 NDA NDA016796 "Akorn, Inc."
DROPERIDOL 2.5 mg/mL "Dopamine D2 Antagonists [MoA],Dopamine-2 Recept
or Antagonist [EPC]"
17478-533_b65191f2-d300-49c7-ae08-78da2cfcff71 17478-533 HUMAN PRESCRIPTI
ON DRUG Myochrysine Gold Sodium Thiomalate INJECTION INTRAMUS
CULAR 20100422 UNAPPROVED DRUG OTHER "Akorn, Inc."
GOLD SODIUM THIOMALATE 50 mg/mL "Standardized Chemical Allergen [EPC],In
creased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/I
ngredient]"
17478-538_04f6a0c3-1a20-4fff-8fde-6e7ab4006035 17478-538 HUMAN PRESCRIPTI
ON DRUG Orphenadrine Citrate Orphenadrine Citrate INJECTION
"Akorn, Inc." ORPHENADRINE CITRATE 30 mg/mL "Centrally-mediated Musc
le Relaxation [PE],Muscle Relaxant [EPC]"
17478-540_7b53c3d0-9181-4566-a2f5-6f9fbefc09ac 17478-540 HUMAN PRESCRIPTI
ON DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride
INJECTION PARENTERAL 20100515 ANDA ANDA078228
"Akorn, Inc." HYDROMORPHONE HYDROCHLORIDE 10 mg/mL "Full Opioid Ago
nists [MoA],Opioid Agonist [EPC]" CII
17478-542_41a4dff1-fd99-4e59-b676-53281070862b 17478-542 HUMAN PRESCRIPTI
ON DRUG Adenosine Adenosine "INJECTION, SOLUTION" INTRAVEN
OUS 20110315 ANDA ANDA078076 "Akorn, Inc." ADENOSIN
E 3 mg/mL "Adenosine Receptor Agonist [EPC],Adenosine Receptor Ago
nists [MoA]"
17478-604_b6b1dacb-551a-44b2-92e2-86ede1c46dd7 17478-604 HUMAN PRESCRIPTI
ON DRUG COSOPT PF Dorzolamide Hydrochloride and Timolol Maleate
SOLUTION/ DROPS OPHTHALMIC 20140514 NDA NDA202667
"Akorn, Inc." DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE 20; 5 mg/mL; m
g/mL "Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],
Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]"
17478-622_d25c3c66-3424-4404-a969-de7c094b4e0a 17478-622 HUMAN OTC DRUG
Sodium Chloride Sodium Chloride OINTMENT OPHTHALMIC 20060508
OTC MONOGRAPH FINAL part349 "Akorn, Inc." SODIUM CHLORIDE 50 mg/g
17478-623_f4ab05eb-c2f7-4505-975c-8b2d554cfd3a 17478-623 HUMAN OTC DRUG
Sodium Chloride Sodium Chloride SOLUTION/ DROPS OPHTHALMIC 19980401
OTC MONOGRAPH FINAL part349 "Akorn, Inc." SODIUM CHLORIDE 50 mg/mL
17478-625_683835ab-0069-4b86-808f-674b2775e797 17478-625 HUMAN PRESCRIPTI
ON DRUG LATANOPROST LATANOPROST SOLUTION/ DROPS OPHTHALMIC
20120701 ANDA ANDA090887 "Akorn, Inc." LATANOPROST
50 ug/mL "Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient]
"
17478-640_b63db481-5b90-4817-b2f9-940ba2473d0b 17478-640 HUMAN PRESCRIPTI
ON DRUG FLURESS Fluorescein Sodium and Benoxinate Hydrochloride SOLUTION
/ DROPS OPHTHALMIC 19950201 UNAPPROVED DRUG OTHER
"Akorn, Inc." BENOXINATE HYDROCHLORIDE; FLUORESCEIN SODIUM 4; 2.5 mg/mL; m
g/mL "Diagnostic Dye [EPC],Dyes [MoA]"
17478-701_91661ee9-04fe-409e-9c4a-858625c53eed 17478-701 HUMAN PRESCRIPTI
ON DRUG IC-Green indocyanine green KIT INTRAVENOUS
20070901 NDA NDA011525 "Akorn, Inc."
17478-703_ad0796b0-1f91-46a5-a18d-4b315ee95fe0 17478-703 HUMAN PRESCRIPTI
ON DRUG Trimethoprim sulfate and Polymyxin B sulfate Trimethoprim sul
fate and Polymyxin B sulfate SOLUTION OPHTHALMIC 19981217
ANDA ANDA065006 "Akorn, Inc." POLYMYXIN B SULFATE; TRIMETHOPRIM SULFAT
E 10000; 1 [USP'U]/mL; mg/mL "Dihydrofolate Reductase Inhibit
or Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450
2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA],Polymyxin-cla
ss Antibacterial [EPC],Polymyxins [Chemical/Ingredient]"
17478-704_af120012-4fed-4126-b227-fb50fba7bffa 17478-704 HUMAN PRESCRIPTI
ON DRUG Paremyd "Hydroxyamphetamine hydrobromide, tropicamide" SOLUTION
OPHTHALMIC 19920130 NDA NDA019261 "Akorn, Inc."
HYDROXYAMPHETAMINE HYDROBROMIDE; TROPICAMIDE 10; 2.5 mg/mL; mg/mL "Adrener
gic Agonists [MoA],Adrenergic Receptor Agonist [EPC],Anticholinergic [EPC],Choli
nergic Antagonists [MoA]"
17478-705_ca9d088a-58a5-448f-8b53-23e356734dfa 17478-705 HUMAN PRESCRIPTI
ON DRUG Betaxolol Betaxolol Hydrochloride SOLUTION/ DROPS OPHTHALM
IC 20030401 ANDA ANDA075386 "Akorn, Inc." BETAXOLO
L HYDROCHLORIDE 5 mg/mL "Adrenergic beta-Antagonists [MoA],beta-Adrenerg
ic Blocker [EPC]"
17478-711_a226e972-e8cd-468e-b39c-9ea734d5ef3a 17478-711 HUMAN PRESCRIPTI
ON DRUG Lidocaine Lidocaine Hydrochloride JELLY TOPICAL 20030801
ANDA ANDA040433 "Akorn, Inc." LIDOCAINE HYDROCHLORIDE 20 mg/mL
17478-713_8ec38b43-795a-45ba-bbd3-8ebd6e1fcdf2 17478-713 HUMAN PRESCRIPTI
ON DRUG Ofloxacin Ofloxacin SOLUTION/ DROPS OPHTHALMIC
20080701 ANDA ANDA076407 "Akorn, Inc." OFLOXACIN
17478-715_7f94cd83-a6f7-4511-8c1b-46c9b6e5bff7 17478-715 HUMAN PRESCRIPTI
ON DRUG Brimonidine Brimonidine Tartrate SOLUTION/ DROPS OPHTHALM
IC 20060907 ANDA ANDA076439 "Akorn, Inc." BRIMONID
INE TARTRATE 2 mg/mL "Adrenergic alpha-Agonists [MoA],alpha-Adrenergi
c Agonist [EPC]"
17478-717_494193f6-b78a-447f-9cf0-127e53748403 17478-717 HUMAN OTC DRUG
Ketotifen Fumarate Ketotifen Fumarate SOLUTION/ DROPS OPHTHALM
IC 20071001 ANDA ANDA077958 "Akorn, Inc." KETOTIFE
N FUMARATE 0.35 mg/mL
17478-719_60ddae47-eb84-455b-af3f-6bf4e3d114bc 17478-719 HUMAN PRESCRIPTI
ON DRUG "Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone"
"Neomycin Sulfate, Polymyxin B Sulfate, Bacitracin Zinc, Hydrocortisone"
OINTMENT OPHTHALMIC 20120725 ANDA ANDA065213
"Akorn, Inc." BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B S
ULFATE 400; 10; 3.5; 10000 [USP'U]/g; mg/g; mg/g; [USP'U]/g "Aminogl
ycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-clas
s Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synth
esis & Repair [PE],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agon
ists [MoA]"
17478-741_3c2026bf-3ee4-4b95-bbb4-561d72251e5b 17478-741 HUMAN PRESCRIPTI
ON DRUG Vancomycin Hydrochloride Vancomycin Hydrochloride
CAPSULE ORAL 20120409 ANDA ANDA065478 "Akorn, Inc."
VANCOMYCIN HYDROCHLORIDE 125 mg/1 "Glycopeptide Antibacterial [EPC
],Glycopeptides [Chemical/Ingredient]"
17478-742_3c2026bf-3ee4-4b95-bbb4-561d72251e5b 17478-742 HUMAN PRESCRIPTI
ON DRUG Vancomycin Hydrochloride Vancomycin Hydrochloride
CAPSULE ORAL 20120409 ANDA ANDA065478 "Akorn, Inc."
17478-761_25e42cf9-e32f-4bfc-862b-91c4238dca43 17478-761 HUMAN PRESCRIPTI
ON DRUG Dronabinol Dronabinol CAPSULE ORAL 20140620
ANDA ANDA079217 "Akorn, Inc." DRONABINOL 2.5 mg/1 "Cannabi
ANDA ANDA079217 "Akorn, Inc." DRONABINOL 5 mg/1 "Cannabi
ANDA ANDA079217 "Akorn, Inc." DRONABINOL 10 mg/1 "Cannabi
17478-766_e07c4c23-d6ff-421b-9d10-c3cc5afe07d3 17478-766 HUMAN PRESCRIPTI
ON DRUG Progesterone Progesterone CAPSULE ORAL 20121004
ANDA ANDA200456 "Akorn, Inc." PROGESTERONE 100 mg/1 "Progest
17478-767_e07c4c23-d6ff-421b-9d10-c3cc5afe07d3 17478-767 HUMAN PRESCRIPTI
ANDA ANDA200456 "Akorn, Inc." PROGESTERONE 200 mg/1 "Progest
17478-792_3cf8d161-f535-4d9d-8eae-d94b225806d8 17478-792 HUMAN PRESCRIPTI
ON DRUG Akten Lidocaine Hydrochloride GEL OPHTHALMIC 20081008
NDA NDA022221 "Akorn, Inc." LIDOCAINE HYDROCHLORIDE ANHYDROUS
35 mg/mL "Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antia
17478-808_59b02f43-ad26-4c56-8a14-9d0fa264ffe1 17478-808 HUMAN PRESCRIPTI
ON DRUG INDIGO CARMINE Indigotindisulfonate Sodium "INJECTION, SOLU
OTHER "Akorn, Inc." INDIGOTINDISULFONATE SODIUM 8 mg/mL
17478-811_867285c1-a591-4751-bff9-59aab9e7b820 17478-811 HUMAN PRESCRIPTI
17478-817_876e7fef-525f-4ae6-add4-8ca1fd7e32be 17478-817 HUMAN PRESCRIPTI
ON DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride INJECTION
INTRAVENOUS 20131112 ANDA ANDA075086 "Akorn, Inc."
DILTIAZEM HYDROCHLORIDE 5 mg/mL "Calcium Channel Antagonists [MoA],Calci
17478-823_59655d2f-7cb0-4a52-beb2-848280632405 17478-823 HUMAN PRESCRIPTI
ON DRUG Ephedrine Sulfate Ephedrine Sulfate INJECTION
ED DRUG OTHER "Akorn, Inc." EPHEDRINE SULFATE 50 mg/mL
17478-824_be7e90d7-f974-4ba9-b5e8-2d21fa1fd98e 17478-824 HUMAN PRESCRIPTI
20130311 ANDA ANDA064030 "Akorn, Inc." ERYTHROMYCIN
5 mg/g "Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macroli
de Antimicrobial [EPC],Macrolides [Chemical/Ingredient]"
17478-825_222f2e92-432e-480e-91a7-c033e311e77f 17478-825 HUMAN PRESCRIPTI
ON DRUG Dehydrated Alcohol Alcohol INJECTION INTRASPINAL
20130308 UNAPPROVED DRUG OTHER "Akorn, Inc." ALCOHOL
0.98 mL/mL
17478-826_88f7a153-56d8-4934-8ff7-d4a64f19e5c3 17478-826 HUMAN PRESCRIPTI
GENTAMICIN SULFATE 3 mg/mL "Aminoglycoside Antibacterial [EPC],Amin
17478-827_3789cbb4-fbab-4985-9fcd-868efe1407b2 17478-827 HUMAN PRESCRIPTI
20130311 ANDA ANDA064093 "Akorn, Inc." GENTAMICIN SULFA
TE 3 mg/g "Aminoglycoside Antibacterial [EPC],Aminoglycosides [Che
mical/Ingredient]"
17478-831_d8aebdd3-0586-4464-a515-abac8e4d96e3 17478-831 HUMAN PRESCRIPTI
ON DRUG Calcitriol Calcitriol INJECTION INTRAVENOUS
20130322 ANDA ANDA078066 "Akorn, Inc." CALCITRIOL
17478-834_1319c78d-4970-4c15-83a9-0e28d4856882 17478-834 HUMAN PRESCRIPTI
INJECTION INTRAMUSCULAR; INTRAVENOUS 20130221 ANDA
ANDA040730 "Akorn, Inc." HYDRALAZINE HYDROCHLORIDE 20 mg/mL
17478-837_a0073823-56c0-4815-bce8-19794558ad2f 17478-837 HUMAN PRESCRIPTI
17478-840_11e9bd9a-8a7d-460a-88e0-4243b32e6c91 17478-840 HUMAN PRESCRIPTI
17478-841_0c2bc497-3558-47bc-9e18-55e51143be66 17478-841 HUMAN PRESCRIPTI
ON DRUG Alfentanil Alfentanil Hydrochloride INJECTION
INTRAVENOUS 20130719 NDA NDA019353 "Akorn, Inc."
ALFENTANIL HYDROCHLORIDE 500 ug/mL "Full Opioid Agonists [MoA],Opio
17478-892_9697a5cd-7988-46e3-a124-577ccb5097ae 17478-892 HUMAN PRESCRIPTI
ON DRUG Diclofenac Diclofenac Sodium SOLUTION/ DROPS OPHTHALM
IC 20080501 ANDA ANDA077845 "Akorn, Inc." DICLOFEN
AC SODIUM 1 mg/mL "Cyclooxygenase Inhibitors [MoA],Decreased Prost
aglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingr
edient],Nonsteroidal Anti-inflammatory Drug [EPC]"
17478-920_b510a7ea-3e31-4c8a-807c-0939e9e78732 17478-920 HUMAN PRESCRIPTI
ON DRUG BALANCED SALT "Calcium Chloride, Magnesium Chloride, Potassium
Chloride, Sodium Acetate, Sodium Chloride, Sodium Citrate" SOLUTION
CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM
CHLORIDE; SODIUM CITRATE .48; .3; .75; 3.9; 6.4; 1.7 mg/mL; mg/mL; mg
/mL; mg/mL; mg/mL; mg/mL "Blood Coagulation Factor [EPC],Increased Coagul
ation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chem
ical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity
[MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC]"
17478-931_262e9104-1a18-421c-935f-fc206758d540 17478-931 HUMAN PRESCRIPTI
17478-932_262e9104-1a18-421c-935f-fc206758d540 17478-932 HUMAN PRESCRIPTI
17478-934_37c43498-42dc-4cea-bcfc-d5a3d5a5f004 17478-934 HUMAN PRESCRIPTI
INJECTION INTRAMUSCULAR; INTRAVENOUS 20090501 ANDA
ANDA040730 "Akorn, Inc." HYDRALAZINE HYDROCHLORIDE 20 mg/mL
17478-937_ea01bc05-ac1c-4943-b463-f3c01443e33e 17478-937 HUMAN PRESCRIPTI
24090-410_614246f0-2e35-4980-abee-223af418919e 24090-410 HUMAN PRESCRIPTI
ON DRUG NitroMist nitroglycerin "AEROSOL, METERED" SUBLINGU
AL 20100501 NDA NDA021780 "Akrimax Pharmaceuticals
, LLC" NITROGLYCERIN 400 ug/1 "Nitrate Vasodilator [EPC],Nitrates [Che
mical/Ingredient],Vasodilation [PE]"
24090-450_7b091426-e819-450f-bf43-d0bdd1aefcfe 24090-450 HUMAN PRESCRIPTI
ON DRUG InnoPran XL propranolol hydrochloride "CAPSULE, EXTEND
ED RELEASE" ORAL 20130601 NDA NDA021438 "Akrimax
Pharmaceuticals, LLC" PROPRANOLOL HYDROCHLORIDE 80 mg/1 "Adrener
gic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]"
24090-451_7b091426-e819-450f-bf43-d0bdd1aefcfe 24090-451 HUMAN PRESCRIPTI
ON DRUG InnoPran XL propranolol hydrochloride "CAPSULE, EXTEND
ED RELEASE" ORAL 20130601 NDA NDA021438 "Akrimax
Pharmaceuticals, LLC" PROPRANOLOL HYDROCHLORIDE 120 mg/1 "Adrener
24090-470_1565d6c9-6116-4184-a288-0b6c668668eb 24090-470 HUMAN PRESCRIPTI
ON DRUG Inderal LA propranolol hydrochloride "CAPSULE, EXTENDED RELEA
SE" ORAL 19830419 NDA NDA018553 "Akrimax Pharmac
euticals, LLC" PROPRANOLOL HYDROCHLORIDE 60 mg/1 "Adrenergic beta
24090-490_af328868-3df0-40c0-9ad5-a8e708fcc61d 24090-490 HUMAN PRESCRIPTI
ON DRUG Tirosint Levothyroxine Sodium CAPSULE ORAL 20100401
NDA NDA022121 "Akrimax Pharmaceuticals, LLC" LEVOTHYROXINE SODIUM
13 ug/1 "l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient]"
24090-681_47563909-f924-455d-8d76-755c76bb3056 24090-681 HUMAN PRESCRIPTI
ON DRUG Primlev oxycodone and acetaminophen TABLET ORAL 20111201
ANDA ANDA040608 "Akrimax Pharmaceuticals, LLC" ACETAMINOPHEN; OXYCODONE
HYDROCHLORIDE 300; 5 mg/1; mg/1 "Full Opioid Agonists [MoA],Opioid Agoni
st [EPC]" CII
HYDROCHLORIDE 300; 7.5 mg/1; mg/1 "Full Opioid Agonists [MoA],Opio
HYDROCHLORIDE 300; 10 mg/1; mg/1 "Full Opioid Agonists [MoA],Opioid Agoni
st [EPC]" CII
24090-720_fbf30002-75be-44b3-876b-c6f460295c2b 24090-720 HUMAN PRESCRIPTI
ON DRUG Suprenza phentermine hydrochloride "TABLET, ORALLY
DISINTEGRATING" ORAL 20121214 NDA NDA202088 "Akrimax
Pharmaceuticals, LLC" PHENTERMINE HYDROCHLORIDE 15 mg/1 "Appetit
e Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Ano
rectic [EPC]" CIV
Pharmaceuticals, LLC" PHENTERMINE HYDROCHLORIDE 30 mg/1 "Appetit
rectic [EPC]" CIV
Pharmaceuticals, LLC" PHENTERMINE HYDROCHLORIDE 37.5 mg/1 "Appetit
rectic [EPC]" CIV
24090-961_4b2d4b7b-8d51-4b28-a787-ebf28be6f3d6 24090-961 HUMAN PRESCRIPTI
ON DRUG Norgestrel/Ethinyl Estradiol norgestrel/ethinyl estradiol
KIT 19760301 NDA AUTHORIZED GENERIC NDA017802
"Akrimax Pharmaceuticals, LLC"
59704-0001_823ad790-d12f-42c0-bf13-dc640c987b1b 59704-0001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS ALA Med dba Pulmonary Care Services OXYGEN
99 L/100L
59434-001_503ef007-a5ac-4abc-90b1-b13bd0a05d08 59434-001 HUMAN OTC DRUG
Ala-Septic Salicyclic Acid CREAM TOPICAL 20131001
OTC MONOGRAPH FINAL part358H Ala-Septic Pharmaceutical Research LLC
SALICYLIC ACID 2 g/100g
68220-055_251eb269-e7ae-11e1-aff1-0800200c9a66 68220-055 HUMAN PRESCRIPTI
ON DRUG Anadrol-50 oxymetholone TABLET ORAL 19720601
NDA NDA016848 Alaven Pharmaceutical OXYMETHOLONE 50 mg/1
CIII
68220-022_2d0c0036-793a-499a-ae56-5d7dcdb62ef2 68220-022 HUMAN PRESCRIPTI
ON DRUG sF Rowasa Mesalamine SUSPENSION RECTAL 20090901
NDA NDA019618 Alaven Pharmaceutical LLC MESALAMINE 4
g/60mL "Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient]"
68220-066_d17d9288-bdc7-4280-b804-5d544c9b3855 68220-066 HUMAN PRESCRIPTI
ON DRUG Rowasa mesalamine ENEMA RECTAL 19880131
NDA NDA019618 Alaven Pharmaceutical LLC MESALAMINE 4
g/60mL "Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient]"
68220-083_083a5779-4727-430f-ae00-674122bbdf51 68220-083 HUMAN PRESCRIPTI
ON DRUG PreferaOB plus DHA "FOLIC ACID, Heme Iron Polypeptide, IRON
DEXTRAN, Potassium Iodide, Zinc Oxide, Selenium, CUPRIC SULFATE, CHOLECALCIFERO
L, THIAMINE MONONITRATE, ALPHA-TOCOPHEROL SUCCINATE, D-, RIBOFLAVIN, NIACINAMIDE
," TABLET ORAL 20101115 UNAPPROVED DRUG OTHER
Alaven Pharmaceutical LLC "ALPHA-TOCOPHEROL SUCCINATE, D-; BIOTIN; CALCIUM
PANTOTHENATE; CHOLECALCIFEROL; CUPRIC SULFATE; CYANOCOBALAMIN; FOLIC ACID; HEME
IRON POLYPEPTIDE; IRON DEXTRAN; NIACINAMIDE; POTASSIUM IODIDE; PYRIDOXINE HYDRO
CHLORIDE; RIBOFLAVIN; SELENIUM; THIAMINE MONONITRATE; ZINC OXIDE" 10; 30;
10; 400; .8; 12; 1; 6; 28; 17; 250; 50; 1.6; 65; 1.5; 4.5 [iU]/1; ug/1; mg
/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; ug
/1 "Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC
],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ov
um Fertilization [PE],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B
12 [Chemical/Ingredient],Vitamin B12 [EPC]"
68220-084_aa72cc66-8257-4185-b563-894032636337 68220-084 HUMAN PRESCRIPTI
ON DRUG PreferaOB "FOLIC ACID, Heme Iron Polypeptide, IRON DEXTRAN
, Potassium Iodide, Zinc Oxide, Selenium, CUPRIC SULFATE, CHOLECALCIFEROL, THIAM
INE MONONITRATE, ALPHA-TOCOPHEROL SUCCINATE, D-, RIBOFLAVIN, NIACINAMIDE,"
TABLET ORAL 20100927 UNAPPROVED DRUG OTHER Alaven P
harmaceutical LLC "ALPHA-TOCOPHEROL SUCCINATE, D-; BIOTIN; CALCIUM PANTOTH
ENATE; CHOLECALCIFEROL; CUPRIC SULFATE; CYANOCOBALAMIN; FOLIC ACID; HEME IRON PO
LYPEPTIDE; IRON DEXTRAN; NIACINAMIDE; POTASSIUM IODIDE; PYRIDOXINE HYDROCHLORIDE
; RIBOFLAVIN; SELENIUM; THIAMINE MONONITRATE; ZINC OXIDE" 10; 30; 10; 400;
.8; 12; 1; 6; 28; 17; 250; 50; 1.6; 65; 1.5; 4.5 [iU]/1; ug/1; mg/1; [iU]
/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; ug/1
"Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Vitamin D [Chemi
cal/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [
EPC]"
68220-085_ff690efc-acac-4103-98ad-3a1613dc5573 68220-085 HUMAN PRESCRIPTI
ON DRUG BiferaRx "FOLIC ACID, Heme Iron Polypeptide, IRON DEXTRAN
, and CYANOCOBALAMIN" TABLET ORAL 20100501 UNAPPROVED DRUG
OTHER Alaven Pharmaceutical LLC CYANOCOBALAMIN; FOLIC ACID; HEME
IRON POLYPEPTIDE; IRON DEXTRAN 25; 1; 6; 22 ug/1; mg/1; mg/1; mg/1 "Vitamin
B 12 [Chemical/Ingredient],Vitamin B12 [EPC]"
68220-086_69e082a6-77dd-46e0-b3eb-90bb6d167b82 68220-086 HUMAN PRESCRIPTI
ON DRUG PreferaOB One "folic acid, heme iron polypeptide, iron dextran
, potassium iodide, zinc oxide, ascorbic acid, cholecalciferol, doconexent, .alp
ha.-tocopherol acetate, dl-, niacinamide, pyridoxine hydrochloride, cyano"
CAPSULE ORAL 20100401 UNAPPROVED DRUG OTHER Alaven P
harmaceutical LLC ".ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; BIOTIN;
CALCIUM PANTOTHENATE; CHOLECALCIFEROL; CYANOCOBALAMIN; DOCONEXENT; FOLIC ACID;
HEME IRON POLYPEPTIDE; IRON DEXTRAN; NIACINAMIDE; POTASSIUM IODIDE; PYRIDOXINE H
YDROCHLORIDE; ZINC OXIDE" 10; 25; 30; 10; 400; 12; 200; 1; 6; 22; 17; 175;
50; 15 [iU]/1; mg/1; ug/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug
/1; mg/1; ug/1 "Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],
Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredien
t],Vitamin B12 [EPC]"
68220-089_c697dfae-210c-43a6-b893-f3054e74901c 68220-089 HUMAN PRESCRIPTI
ON DRUG Prefera OB plus DHA "FOLIC ACID, Heme Iron Polypeptide, IRON
DEXTRAN, Potassium Iodide, Zinc Oxide, Selenium, CUPRIC SULFATE, CHOLECALCIFERO
L, THIAMINE MONONITRATE, ALPHA-TOCOPHEROL SUCCINATE, D-, RIBOFLAVIN, NIACINAMIDE
," TABLET ORAL 20090401 UNAPPROVED DRUG OTHER
Alaven Pharmaceutical LLC "ALPHA-TOCOPHEROL SUCCINATE, D-; BIOTIN; CALCIUM
PANTOTHENATE; CHOLECALCIFEROL; CUPRIC SULFATE; CYANOCOBALAMIN; FOLIC ACID; HEME
IRON POLYPEPTIDE; IRON DEXTRAN; NIACINAMIDE; POTASSIUM IODIDE; PYRIDOXINE HYDRO
CHLORIDE; RIBOFLAVIN; SELENIUM; THIAMINE MONONITRATE; ZINC OXIDE" 10; 30;
10; 400; .8; 12; 1; 6; 22; 17; 175; 50; 1.6; 65; 1.5; 15 [iU]/1; ug/1; mg
/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg
/1 "Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC
],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ov
um Fertilization [PE],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B
68220-111_034da52b-7d64-4126-b918-3df9eb478ba2 68220-111 HUMAN PRESCRIPTI
ON DRUG Levsin HYOSCYAMINE SULFATE "INJECTION, SOLUTION" SUBCUTAN
EOUS 20081201 UNAPPROVED DRUG OTHER Alaven Pharmaceu
tical LLC HYOSCYAMINE SULFATE 0.5 mg/mL
68220-112_df2a7cba-b81a-4c69-91d9-cbe23cc4a15c 68220-112 HUMAN PRESCRIPTI
ON DRUG Levsin hyoscyamine sulfate TABLET ORAL 19550601
UNAPPROVED DRUG OTHER Alaven Pharmaceutical LLC HYOSCYAMINE SULF
ATE 0.125 mg/1
68220-113_f38ece40-b890-11e2-9e96-0800200c9a66 68220-113 HUMAN PRESCRIPTI
ON DRUG Levsin SL hyoscyamine sulfate "TABLET, ORALLY DISINTEGRATING"
ORAL 20081201 UNAPPROVED DRUG OTHER Alaven Pharmaceu
tical LLC HYOSCYAMINE SULFATE 0.125 mg/1
68220-118_ae2a78b1-b811-11e2-9e96-0800200c9a66 68220-118 HUMAN PRESCRIPTI
ON DRUG NuLev hyoscyamine sulfate "TABLET, CHEWABLE" ORAL
20081201 UNAPPROVED DRUG OTHER Alaven Pharmaceutical LL
C HYOSCYAMINE SULFATE 0.125 mg/1
68220-130_98c68a99-158c-11e3-8ffd-0800200c9a66 68220-130 HUMAN PRESCRIPTI
ON DRUG Colyte with flavor packs "Polyethylene glycol 3350, Sodium chlori
de, Potassium chloride, Sodium bicarbonate, and Sodium sulfate" "POWDER, FOR SOL
UTION" NASOGASTRIC; ORAL 19990407 NDA NDA018983
Alaven Pharmaceutical LLC POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SO
DIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE 240; 2.98; 6.72; 5.84; 2
2.72 g/4L; g/4L; g/4L; g/4L; g/4L "Osmotic Activity [MoA],Osmotic Laxative
68220-131_e0274a28-194d-4d9e-9421-61e399ff0b9b 68220-131 HUMAN PRESCRIPTI
ON DRUG TRILYTE with flavor packs "Polyethylene Glycol 3350, sodium chlori
de, sodium bicarbonate and potassium chloride" "POWDER, FOR SOLUTION" NASOGAST
RIC; ORAL 20040624 ANDA ANDA076491 Alaven Pharmaceu
tical LLC POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE
; SODIUM CHLORIDE 420; 1.48; 5.72; 11.2 g/4L; g/4L; g/4L; g/4L "Osmotic
C]"
68220-133_98c68a88-158c-11e3-8ffd-0800200c9a66 68220-133 HUMAN PRESCRIPTI
ON DRUG Colyte "POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, POTASSIUM CH
LORIDE, SODIUM BICARBONATE, and SODIUM SULFATE ANHYDROUS" "POWDER, FOR SOL
UTION" NASOGASTRIC; ORAL 20100901 NDA NDA018983
Alaven Pharmaceutical LLC POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SO
DIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE 227.1; 2.82; 6.36; 5.53;
21.5 g/3.785L; g/3.785L; g/3.785L; g/3.785L; g/3.785L "Osmotic Activit
y [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Sec
retion [PE],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC]"
68220-140_90bba35d-271b-4c95-9dde-6e4d43f97822 68220-140 HUMAN PRESCRIPTI
ON DRUG Cortifoam hydrocortisone acetate "AEROSOL, FOAM" RECTAL
19820212 NDA NDA017351 Alaven Pharmaceutical LLC
HYDROCORTISONE ACETATE 1500 mg/15g "Corticosteroid [EPC],Corticosteroid Hor
68220-141_02ef1480-500b-11e0-b8af-0800200c9a66 68220-141 HUMAN PRESCRIPTI
ON DRUG Proctocream HC Hydrocortisone CREAM TOPICAL 20110318
ANDA ANDA089414 Alaven Pharmaceutical LLC HYDROCORTISONE 25
68220-142_6a3a7450-e6f4-11e1-aff1-0800200c9a66 68220-142 HUMAN PRESCRIPTI
ON DRUG Proctofoam HC hydrocortisone acetate and pramoxine hydrochlori
de "AEROSOL, FOAM" TOPICAL 19780726 ANDA ANDA086195
Alaven Pharmaceutical LLC HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE
100; 100 mg/10g; mg/10g "Corticosteroid [EPC],Corticosteroid Hormone Rec
68220-143_f2bdbe25-0124-4b39-ab04-77d2250b5835 68220-143 HUMAN OTC DRUG
Proctofoam pramoxine hydrochloride "AEROSOL, FOAM" RECTAL 19900930
OTC MONOGRAPH FINAL part346 Alaven Pharmaceutical LLC PRAMOXINE HYDROC
HLORIDE 150 mg/15g
68220-144_cc56b07d-845a-4729-ad94-ee691215afac 68220-144 HUMAN PRESCRIPTI
ON DRUG Epifoam hydrocortisone acetate and pramoxine hydrochloride
"AEROSOL, FOAM" TOPICAL 19791219 ANDA ANDA086457 Alaven P
harmaceutical LLC HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE 100; 100
mg/10g; mg/10g "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [
MoA]"
68220-160_6394448c-9f58-4243-be16-b52fd228ad04 68220-160 HUMAN PRESCRIPTI
ON DRUG Dipentum olsalazine sodium "CAPSULE, GELATIN COATED
" ORAL 19900731 NDA NDA019715 Alaven Pharmaceu
tical LLC OLSALAZINE SODIUM 250 mg/1 "Aminosalicylate [EPC],A
minosalicylic Acids [Chemical/Ingredient]"
68233-011_8f7da638-8b96-48c6-b747-b37d6332d6ad 68233-011 HUMAN OTC DRUG
Max Revive "MENTHOL, METHYL SALICYLATE" PATCH TOPICAL 20030901
OTC MONOGRAPH NOT FINAL part348 "Albert Max, Inc." MENTHOL; METHYL SALICYLA
TE .05; .005 g/g; g/g
68233-012_8e0ab908-76d4-4767-9512-99a37aaa056c 68233-012 HUMAN OTC DRUG
Herbal UTAPLAS.TN "MENTHOL, METHYL SALICYLATE" PATCH TOPICAL
20041201 OTC MONOGRAPH NOT FINAL part348 "Albert Max, Inc."
MENTHOL; METHYL SALICYLATE .05; .005 g/g; g/g
68233-021_78f91c58-6d48-4ef0-85a2-2f38f973ce4b 68233-021 HUMAN OTC DRUG
PAIN FREE "MENTHOL, METHYL SALYCILATE, BORNEOL" OINTMENT
TOPICAL 20051101 OTC MONOGRAPH NOT FINAL part348 "Albert Max, Inc
." BORNEOL; MENTHOL; METHYL SALICYLATE .02; .02; .01 g/g; g/g; g/g
68233-031_68da1c7d-cdc0-4152-9e52-a82d35dbbac0 68233-031 HUMAN OTC DRUG
Max Revive "MENTHOL, METHYL SALICYLATE" SPRAY TOPICAL 20030901
TE .0781; .0302 g/mL; g/mL
68233-901_5343a067-6336-4fdc-b309-26065a5148e5 68233-901 HUMAN OTC DRUG
Herbal UTAPLAS.TN "MENTHOL, METHYL SALICYLATE" PATCH TOPICAL
20041201 OTC MONOGRAPH NOT FINAL part348 "Albert Max, Inc."
MENTHOL; METHYL SALICYLATE .05; .01 g/g; g/g
68233-902_0093fb0e-d3ec-451f-8a78-edc85a760374 68233-902 HUMAN OTC DRUG
Max Revive "MENTHOL, METHYL SALICYLATE" PATCH TOPICAL 20030901
TE .05; .01 g/g; g/g
12488-0100_3bf5c112-24ca-4ecd-b479-8aff193427c7 12488-0100 HUMAN OTC DRUG
St. Ives Blemish and Blackhead Control salicylic acid EMULSION
TOPICAL 20090601 OTC MONOGRAPH FINAL part333D Alberto
Culver USA Inc. SALICYLIC ACID 0.02 g/g
12488-2000_ba74ffda-eafa-4d17-838e-c2f4af85227b 12488-2000 HUMAN OTC DRUG
Simple Vital Vitamin Day SPF 15 "Homosalate, Octisalate, Avobenzone, and
Octocrylene" EMULSION TOPICAL 20120101 OTC MONOGRAPH FI
NAL part352 Alberto-Culver USA Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTO
CRYLENE .03; .12; .05; .027 g/g; g/g; g/g; g/g
12488-0200_cd125513-f13b-4ccf-aa0d-f304d79964a0 12488-0200 HUMAN OTC DRUG
St. Ives Blemish and Blackhead Facial Salicylic Acid SOAP TOPICAL
20090601 OTC MONOGRAPH FINAL part333D Alberto-Culver U
SA Inc. SALICYLIC ACID 0.02 mL/mL
12488-0300_b7674d93-a6bb-44ab-a234-e4c743565cf0 12488-0300 HUMAN OTC DRUG
St. Ives Naturally Clear Green Tea Facial Salicylic Acid SOAP
TOPICAL 20100131 OTC MONOGRAPH FINAL part333D Alberto-
Culver USA Inc. SALICYLIC ACID 0.01 mL/mL
12488-0400_488df815-5438-42ad-9ff7-7efec1b767d2 12488-0400 HUMAN OTC DRUG
St. Ives Naturally Clear Green Tea Facial Salicylic Acid SOAP
Culver USA Inc. SALICYLIC ACID 0.02 mL/mL
12488-0500_3f4f4eb1-0893-48d3-976b-2a87f35ef053 12488-0500 HUMAN OTC DRUG
ST. IVES BODY SCRUB NATURALLY CLEAR SKIN GREEN TEA Salicylic Acid
EMULSION TOPICAL 20110214 OTC MONOGRAPH FINAL part333D
Alberto-Culver USA Inc. SALICYLIC ACID 0.02 mL/mL
12488-0600_a87e2ede-d0ec-408f-bcf0-ae3fc949b269 12488-0600 HUMAN OTC DRUG
ST. IVES BODY WASH NATURALLY CLEAR SKIN GREEN TEA Salicylic Acid
SOAP TOPICAL 20110214 OTC MONOGRAPH FINAL part333D
Alberto-Culver USA Inc. SALICYLIC ACID 0.02 mL/mL
12488-0700_b2a9c916-0244-4fc5-8569-b2aeb7eade7c 12488-0700 HUMAN OTC DRUG
ST. IVES NATURALLY CLEAR SKIN GREEN TEA FACIAL Salicylic Acid SOAP
Culver USA Inc. SALICYLIC ACID 0.02 g/g
12488-1000_0f4cc7e8-4cb6-430e-afb4-9f4cb6e4a742 12488-1000 HUMAN OTC DRUG
Noxzema Triple Clean Triclosan SOAP TOPICAL 20090601
OTC MONOGRAPH FINAL part333 Alberto-Culver USA Inc. TRICLOSAN 0.003
g/g
12488-1100_c9527f3e-b936-4d90-b925-5f3c9824f332 12488-1100 HUMAN OTC DRUG
Noxzema Triple Clean Salicylic Acid CLOTH TOPICAL 20090601
OTC MONOGRAPH FINAL part333D Alberto-Culver USA Inc. SALICYLIC ACID
0.02 g/g
12488-1200_344434e7-000a-4c61-9dbf-c95a77f2f308 12488-1200 HUMAN OTC DRUG
Noxzema Salicyclic Acid SOAP TOPICAL 20100101 OTC MONO
GRAPH FINAL part333D Alberto-Culver USA Inc. SALICYLIC ACID 0.01
g/g
12488-1300_bb7e45f6-0697-456a-adf1-6b275cc8e512 12488-1300 HUMAN OTC DRUG
Noxzema Salicyclic Acid SOAP TOPICAL 20100101 OTC MONO
GRAPH FINAL part333D Alberto-Culver USA Inc. SALICYLIC ACID 0.01
mL/mL
12488-1800_aba16eab-dfe7-4370-bf7a-43059ccccf0d 12488-1800 HUMAN OTC DRUG
Nu Skin Epoch Alcohol GEL TOPICAL 20090601 OTC MONO
GRAPH FINAL part333 Alberto-Culver USA Inc. ALCOHOL 61.9937 mL/100mL
42908-071_9521c4be-4c25-4822-b87c-af2b87766be8 42908-071 HUMAN OTC DRUG
PAUL AND JOE SILKY SMOOTH FOUNDATION UV 100 OCTINOXATE and TITANIUM
DIOXIDE EMULSION TOPICAL 20140301 OTC MONOGRAPH NOT FINAL
part352 "Albion Co., Ltd" OCTINOXATE; TITANIUM DIOXIDE 50; 115.1
mg/mL; mg/mL
42908-072_e79f2e71-4eb6-453c-b7e6-fcdfe6030e98 42908-072 HUMAN OTC DRUG
PAUL and JOE SILKY SMOOTH FOUNDATION UV 101 OCTINOXATE and TITANIUM
mg/mL; mg/mL
42908-073_637f2bab-da97-4acc-bf23-1d85e46fd343 42908-073 HUMAN OTC DRUG
mg/mL; mg/mL
42908-074_39fff27c-0a54-4449-9635-7851fa0363b2 42908-074 HUMAN OTC DRUG
mg/mL; mg/mL
42908-075_37482967-13b4-40dc-9f72-5941bcf87fa4 42908-075 HUMAN OTC DRUG
mg/mL; mg/mL
42908-076_fe31b09c-c3b5-4111-b947-25cc823d237f 42908-076 HUMAN OTC DRUG
mg/mL; mg/mL
42908-077_ed283f0f-4872-451f-b068-b9c94b74ed97 42908-077 HUMAN OTC DRUG
mg/mL; mg/mL
42908-201_f7b90afe-b683-4f1e-a908-9b0abac4a8ae 42908-201 HUMAN OTC DRUG
PAUL AND JOE PROTECTIVE FOUNDATION PRIMER UV "OCTINOXATE, TITANIUM DI
OXIDE, and ZINC OXIDE" EMULSION TOPICAL 20080201 OTC MONO
GRAPH NOT FINAL part352 "Albion Co., Ltd" OCTINOXATE; TITANIUM DIOXIDE; ZI
NC OXIDE 50; 59; 81 mg/mL; mg/mL; mg/mL
52272-001_c38df570-c6b2-4320-8432-f0c97bb09d56 52272-001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS Albright Welding & Supply Co Inc OXYGEN
990 mL/L
55662-0117_c9d9232a-31ea-41d5-8355-cec79c6d70bb 55662-0117 HUMAN OTC DRUG
HemOral "Aesculus hippocastanum, Aloe socotrina, Apis mellifica, Bryonia
, Calcarea fluorica, Carbo vegetabilis, Causticum, Collinsonia canadensis, Echin
acea angustifolia, Hamamelis virginiana, Lycopodium clavatum, Sulphur" LIQUID
ORAL 20110601 UNAPPROVED HOMEOPATHIC Alchemed
ACTIVATED CHARCOAL; ALOE; APIS MELLIFERA; BRYONIA ALBA ROOT; CALCIUM FLUORIDE; C
AUSTICUM; COLLINSONIA CANADENSIS ROOT; ECHINACEA ANGUSTIFOLIA; HAMAMELIS VIRGINI
ANA ROOT BARK/STEM BARK; HORSE CHESTNUT; LYCOPODIUM CLAVATUM SPORE; SULFUR
10; 4; 4; 4; 8; 6; 3; 3; 3; 3; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/
mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL;
[hp_X]/mL
58132-3331_c2b362c3-36dc-40ef-91be-242d45a09b47 58132-3331 HUMAN OTC DRUG
Alcis Daily Relief Pain Relief Trolamine Salicylate CREAM TOPICAL
20090309 OTC MONOGRAPH NOT FINAL part348 "Alcis Topical, Inc."
TROLAMINE SALICYLATE 10 g/100mL
0065-0260_9464bd7e-a00b-8441-52ed-e7442a88ad65 0065-0260 HUMAN PRESCRIPTI
ON DRUG Travatan Z travoprost SOLUTION OPHTHALMIC
20061020 NDA NDA021994 "Alcon Laboratories, Inc"
TRAVOPROST 0.04 mg/mL "Prostaglandin Analog [EPC],Prostaglandins [Chem
ical/Ingredient]"
0065-0627_4369f9ff-e961-4c02-b539-264f59ee7892 0065-0627 HUMAN PRESCRIPTI
ON DRUG Vexol rimexolone SUSPENSION OPHTHALMIC 19950915
NDA NDA020474 "Alcon Laboratories, Inc" RIMEXOLONE 10
0065-0002_d0ce806c-1f96-4db7-be22-24d1873ae863 0065-0002 HUMAN PRESCRIPTI
ON DRUG NEVANAC nepafenac SUSPENSION OPHTHALMIC 20050906
NDA NDA021862 "Alcon Laboratories, Inc." NEPAFENAC 1
mg/mL "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compound
0065-0006_6f90aa43-79b3-c4fa-7a59-337245229d7f 0065-0006 HUMAN PRESCRIPTI
ON DRUG MOXEZA moxifloxacin hydrochloride SOLUTION OPHTHALM
IC 20110118 NDA NDA022428 "Alcon Laboratories, Inc
." MOXIFLOXACIN HYDROCHLORIDE 5 mg/mL "Quinolone Antimicrobial
[EPC],Quinolones [Chemical/Ingredient]"
0065-0023_bea74344-8646-44c0-8979-a686fb265402 0065-0023 HUMAN PRESCRIPTI
ON DRUG MIOSTAT carbachol SOLUTION OPHTHALMIC 19740415
NDA NDA016968 "Alcon Laboratories, Inc." CARBACHOL 0.1
mg/mL
0065-0085_6dfea27f-84de-7c12-81e1-1e1ada280cd4 0065-0085 HUMAN OTC DRUG
Naphcon A naphazoline hydrochloride and pheniramine maleate
"Alcon Laboratories, Inc." NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE
.25; 3 mg/mL; mg/mL
0065-0096_f3ed1cd6-c8d8-4126-8caf-e2b9229a28dd 0065-0096 HUMAN PRESCRIPTI
ON DRUG Flarex fluorometholone acetate SUSPENSION OPHTHALMIC
19920206 NDA NDA019079 "Alcon Laboratories, Inc."
FLUOROMETHOLONE ACETATE 1 mg/mL "Corticosteroid [EPC],Corticosteroid Hor
0065-0246_a2957c48-05ee-4300-b55a-11461b4a9548 0065-0246 HUMAN PRESCRIPTI
ON DRUG Betoptic S betaxolol hydrochloride SUSPENSION OPHTHALM
." BETAXOLOL HYDROCHLORIDE 2.8 mg/mL "Adrenergic beta-Antagonists [Mo
0065-0271_d9fc5f0c-e855-4919-8d90-78755533f614 0065-0271 HUMAN PRESCRIPTI
ON DRUG Patanol olopatadine hydrochloride SOLUTION/ DROPS OPHTHALM
." OLOPATADINE HYDROCHLORIDE 1 mg/mL "Decreased Histamine Rel
ease [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor
[EPC]"
0065-0272_0faca3f4-e954-44f1-95bf-43ae8a65b4e2 0065-0272 HUMAN PRESCRIPTI
ON DRUG PATADAY olopatadine hydrochloride SOLUTION/ DROPS OPHTHALM
." OLOPATADINE HYDROCHLORIDE 2 mg/mL "Decreased Histamine Rel
[EPC]"
0065-0275_fba05aa8-ae46-a5cf-4487-9dc82eed4f9d 0065-0275 HUMAN PRESCRIPTI
ON DRUG Azopt brinzolamide SUSPENSION OPHTHALMIC 19980430
NDA NDA020816 "Alcon Laboratories, Inc." BRINZOLAMIDE 10
mg/mL "Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA]"
0065-0325_0807675a-79c7-4d50-9c00-5d42c18bd052 0065-0325 HUMAN PRESCRIPTI
ON DRUG EMADINE EMEDASTINE DIFUMARATE SOLUTION OPHTHALMIC
EMEDASTINE DIFUMARATE 0.884 mg/mL "Histamine H1 Receptor Antagonists [MoA]
,Histamine-1 Receptor Inhibitor [EPC]"
0065-0332_f66ac0b2-4803-e013-7941-ffa92db8082e 0065-0332 HUMAN PRESCRIPTI
ON DRUG PATANASE olopatadine hydrochloride "SPRAY, METERED"
NASAL 20080428 NDA NDA021861 "ALCON LABORATORIES, INC
." OLOPATADINE HYDROCHLORIDE 665 ug/1 "Decreased Histamine Rel
[EPC]"
0065-0333_7bb0d74e-7db8-5fd2-193e-cd1540ed6f7a 0065-0333 HUMAN OTC DRUG
ZADITOR ketotifen fumarate SOLUTION OPHTHALMIC 20090922
NDA NDA021066 "Alcon Laboratories, Inc." KETOTIFEN FUMARATE
0.35 mg/mL
0065-0342_496b1b6a-72a1-b825-e3c3-2655a8c20c42 0065-0342 HUMAN PRESCRIPTI
ON DRUG Mydfrin phenylephrine hydrochloride SOLUTION OPHTHALM
IC 19790215 UNAPPROVED DRUG OTHER "Alcon Laborator
ies, Inc." PHENYLEPHRINE HYDROCHLORIDE 25 mg/mL "alpha-1 Adrener
0065-0345_d3df0c03-3d1d-4ebd-885a-f139d4507ca3 0065-0345 HUMAN PRESCRIPTI
ON DRUG ALOMIDE lodoxamide tromethamine SOLUTION/ DROPS OPHTHALMIC
LODOXAMIDE TROMETHAMINE 1.78 mg/mL "Decreased Histamine Release [PE],Mast C
ell Stabilizer [EPC]"
0065-0355_d62153f0-c46f-4c63-b16a-bbca36149981 0065-0355 HUMAN PRESCRIPTI
ON DRUG Mydriacyl tropicamide SOLUTION OPHTHALMIC
19590401 ANDA ANDA084306 "Alcon Laboratories, Inc."
TROPICAMIDE 10 mg/mL "Anticholinergic [EPC],Cholinergic Antagonists [
MoA]"
0065-0359_b628f767-5888-40f1-bd62-140aa64632e4 0065-0359 HUMAN PRESCRIPTI
ON DRUG Cyclomydril cyclopentolate hydrochloride and phenylephrine h
ydrochloride SOLUTION/ DROPS OPHTHALMIC 19580630 ANDA
ANDA084300 "Alcon Laboratories, Inc." CYCLOPENTOLATE HYDROCHLORIDE; PH
ENYLEPHRINE HYDROCHLORIDE 2; 10 mg/mL; mg/mL "alpha-1 Adrenergic Agon
ist [EPC],Adrenergic alpha1-Agonists [MoA]"
0065-0395_04b7e0eb-3b7f-4f6f-a84f-14d9abf1749c 0065-0395 HUMAN PRESCRIPTI
ON DRUG Cyclogyl cyclopentolate hydrochloride SOLUTION
OPHTHALMIC 19751015 ANDA ANDA084108 "Alcon Laborator
ies, Inc." CYCLOPENTOLATE HYDROCHLORIDE 5 mg/mL
0065-0411_1cb196ea-0234-4316-b912-d085b9326e89 0065-0411 HUMAN PRESCRIPTI
ON DRUG Betadine povidone-iodine SOLUTION OPHTHALMIC
POVIDONE-IODINE 5 mg/mL
0065-0416_3ca1102f-5239-b759-3b60-727055ad339a 0065-0416 HUMAN OTC DRUG
Tears Naturale Free "dextran 70, hypromellose 2910" SOLUTION/ DROPS
OPHTHALMIC 19901101 OTC MONOGRAPH FINAL part349 "Alcon L
aboratories, Inc." DEXTRAN 70; HYPROMELLOSE 2910 (4000 MPA.S) 1; 3
mg/mL; mg/mL
0065-0418_74a35013-1c6e-41cb-a867-e2b7bf28187e 0065-0418 HUMAN OTC DRUG
Tears Naturale II Polyquad dextran 70 and hypromellose 2910
SOLUTION/ DROPS OPHTHALMIC 19900801 OTC MONOGRAPH FINAL
part349 "Alcon Laboratories, Inc." DEXTRAN 70; HYPROMELLOSE 2910 (4000 MPA.
S) 1; 3 mg/mL; mg/mL
0065-0419_a3df9cbc-2383-ae3c-1a17-8dca671b0d8a 0065-0419 HUMAN OTC DRUG
BION TEARS "Dextran, Hypromellose" SOLUTION/ DROPS OPHTHALMIC
19921019 OTC MONOGRAPH FINAL part349 "Alcon Laboratories, Inc
." DEXTRAN 70; HYPROMELLOSE 2910 (4000 MPA.S) 1; 3 mg/mL; mg/mL
0065-0426_331cd37b-5826-bd74-adb7-c13167c6fb81 0065-0426 HUMAN OTC DRUG
TEARS Naturale FORTE "Dextran 70, Glycerin, Hypromellose" SOLUTION
/ DROPS OPHTHALMIC 20030102 OTC MONOGRAPH FINAL part349
"Alcon Laboratories, Inc." DEXTRAN 70; GLYCERIN; HYPROMELLOSES 1; 2; 3
mg/mL; mg/mL; mg/mL
0065-0429_39aedb5c-f253-e94a-8ea9-554d88bf7ebf 0065-0429 HUMAN OTC DRUG
Systane Lubricant polyethylene glycol 400 and Propylene Glycol
part349 "Alcon Laboratories, Inc." POLYETHYLENE GLYCOL 400; PROPYLENE GLYCO
L 4; 3 mg/mL; mg/mL
0065-0454_718fb8b3-3933-6f09-1410-7107eedf8547 0065-0454 HUMAN OTC DRUG
Systane polyethylene glycol 400 and propylene glycol GEL OPHTHALM
IC 20110209 OTC MONOGRAPH FINAL part349 "Alcon Laborator
ies, Inc." POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; m
g/mL
0065-0474_3c2aecf8-04b4-b1a6-69ff-ad039c2175bb 0065-0474 HUMAN OTC DRUG
Systane hypromellose GEL OPHTHALMIC 20121215
OTC MONOGRAPH FINAL part349 "Alcon Laboratories, Inc." HYPROMELLOSE 291
0 (4000 MPA.S) 3 mg/g
0065-0509_a2c681ba-9612-e2ba-a49c-22c4cbdfcb64 0065-0509 HUMAN OTC DRUG
Systane Nighttime mineral oil and white petrolatum OINTMENT
OPHTHALMIC 20080626 OTC MONOGRAPH FINAL part349 "Alcon L
aboratories, Inc." MINERAL OIL; PETROLATUM 30; 940 mg/g; mg/g
0065-0543_a2412381-d9ed-4d7e-acb1-a97e730b12db 0065-0543 HUMAN PRESCRIPTI
ON DRUG TRIESENCE triamcinolone acetonide INJECTION OPHTHALM
." TRIAMCINOLONE ACETONIDE 40 mg/mL
0065-0631_d2e56679-1620-4497-a9a3-5a333e873d5e 0065-0631 HUMAN PRESCRIPTI
ON DRUG MAXITROL "neomycin sulfate, polymyxin b sulfate and dexam
ethasone" OINTMENT OPHTHALMIC 19720117 NDA
NDA050065 "Alcon Laboratories, Inc." DEXAMETHASONE; NEOMYCIN SULFATE;
POLYMYXIN B SULFATE 1; 3.5; 10000 mg/g; mg/g; [USP'U]/g "Aminoglycoside
Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antiba
cterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticostero
id Hormone Receptor Agonists [MoA]"
0065-0638_671f0d1f-fad2-4f27-b4b9-4e2fabd3e83f 0065-0638 HUMAN PRESCRIPTI
ON DRUG OMNIPRED prednisolone acetate SUSPENSION OPHTHALM
." PREDNISOLONE ACETATE 10 mg/mL "Corticosteroid [EPC],Corticoste
roid Hormone Receptor Agonists [MoA]"
0065-0643_222896e5-38c7-158b-1145-07001b361d5a 0065-0643 HUMAN PRESCRIPTI
ON DRUG Tobrex tobramycin SOLUTION OPHTHALMIC 19810315
NDA NDA050541 "Alcon Laboratories, Inc." TOBRAMYCIN 3
mg/mL "Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient
]"
0065-0644_2e5b10f7-9127-4dc0-84bf-0fd88b25d374 0065-0644 HUMAN PRESCRIPTI
ON DRUG TOBREX tobramycin OINTMENT OPHTHALMIC 19810628
NDA NDA050555 "Alcon Laboratories, Inc." TOBRAMYCIN 3
mg/g "Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient
]"
0065-0645_b703806d-0139-42aa-a8ea-8dd3e9470a98 0065-0645 HUMAN PRESCRIPTI
ON DRUG NATACYN natamycin SUSPENSION OPHTHALMIC 19801231
NDA NDA050514 "Alcon Laboratories, Inc." NATAMYCIN 50
mg/mL "Polyene Antimicrobial [EPC],Polyenes [Chemical/Ingredient]"
0065-0647_8ea6e851-7529-4e50-ba22-92400b6923ed 0065-0647 HUMAN PRESCRIPTI
ON DRUG TobraDex tobramycin and dexamethasone SUSPENSION
OPHTHALMIC 19880915 NDA NDA050592 "Alcon Laborator
ies, Inc." DEXAMETHASONE; TOBRAMYCIN 1; 3 mg/mL; mg/mL "Aminogl
ycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Corticosteroid
0065-0648_0c5b0aec-0c14-43b5-a807-cb5ea4928f75 0065-0648 HUMAN PRESCRIPTI
ON DRUG TobraDex tobramycin and dexamethasone OINTMENT
ies, Inc." DEXAMETHASONE; TOBRAMYCIN 1; 3 mg/g; mg/g "Aminogl
0065-0652_9daa066f-64fa-4fd2-9d63-0b71d780ff8d 0065-0652 HUMAN PRESCRIPTI
ON DRUG TOBRADEX ST tobramycin / dexamethasone SUSPENSION
ies, Inc." DEXAMETHASONE; TOBRAMYCIN .5; 3 mg/mL; mg/mL "Aminogl
0065-0654_8a7f41ac-66a6-4812-ac6d-909ea6912579 0065-0654 HUMAN PRESCRIPTI
ON DRUG CILOXAN ciprofloxacin hydrochloride OINTMENT OPHTHALM
." CIPROFLOXACIN HYDROCHLORIDE 3.33 mg/g "Quinolone Antimicrobial
0065-0656_dfc84b0a-5724-41b3-99fc-e64688fcd4fc 0065-0656 HUMAN PRESCRIPTI
ON DRUG Ciloxan ciprofloxacin hydrochloride SOLUTION OPHTHALM
." CIPROFLOXACIN HYDROCHLORIDE 3.5 mg/mL "Quinolone Antimicrobial
0065-0660_99b736eb-b121-46d9-b7a0-840cd042363e 0065-0660 HUMAN PRESCRIPTI
ON DRUG IOPIDINE apraclonidine hydrochloride SOLUTION
ies, Inc." APRACLONIDINE HYDROCHLORIDE 10 mg/mL "Adrenergic alph
a-Agonists [MoA],alpha-Adrenergic Agonist [EPC]"
0065-0665_f59759c2-e814-4998-8800-a646a0f1c2a7 0065-0665 HUMAN PRESCRIPTI
ON DRUG Iopidine apraclonidine SOLUTION OPHTHALMIC
APRACLONIDINE HYDROCHLORIDE 5 mg/mL "Adrenergic alpha-Agonists [MoA]
,alpha-Adrenergic Agonist [EPC]"
0065-0702_c391d01e-09dc-b032-899a-0352cd74c282 0065-0702 HUMAN PRESCRIPTI
ON DRUG atropine sulfate atropine sulfate SOLUTION
OPHTHALMIC 20000612 UNAPPROVED DRUG OTHER "Alcon L
aboratories, Inc." ATROPINE SULFATE 10 mg/mL "Anticholinergic
[EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cho
linergic Muscarinic Antagonists [MoA]"
0065-0741_7bc36479-fa1f-39ee-303a-e671915e09a6 0065-0741 HUMAN PRESCRIPTI
ON DRUG Tetracaine Hydrochloride tetracaine hydrochloride
SOLUTION OPHTHALMIC 19690328 UNAPPROVED DRUG OTHER
"Alcon Laboratories, Inc." TETRACAINE HYDROCHLORIDE 5 mg/mL
"Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE]
"
0065-0795_4bd4d59c-eb3b-4a5e-9eb7-ae95b0a92bea 0065-0795 HUMAN PRESCRIPTI
ON DRUG BSS balanced salt solution SOLUTION OPHTHALMIC
/mL; mg/mL; mg/mL; mg/mL "Potassium Compounds [Chemical/Ingredient],Potas
sium Salt [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Acti
vity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],
Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA]"
0065-0795_d2f55b3f-0873-4536-aedb-2829a91927c7 0065-0795 HUMAN PRESCRIPTI
0065-0800_286cc060-8659-c92e-a056-edf6746d3de1 0065-0800 HUMAN PRESCRIPTI
ON DRUG BSS PLUS "balanced salt solution enriched with bicarbonat
e, dextrose, and glutathione" KIT 19820628 NDA
NDA018469 "Alcon Laboratories, Inc."
0065-0800_452b57f7-1b9e-57f3-8555-ad3d7117563d 0065-0800 HUMAN PRESCRIPTI
0065-0800_bc616aad-0be0-bd23-58d2-cf727aa9bb2a 0065-0800 HUMAN PRESCRIPTI
0065-1431_04158e63-bdbc-071f-1300-302b3255e943 0065-1431 HUMAN OTC DRUG
Systane Ultra Polyethylene Glycol 400 and Propylene Glycol SOLUTION
"Alcon Laboratories, Inc." POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL
4; 3 mg/mL; mg/mL
0065-1433_c7b1a03a-a5f2-409e-a34a-d6f166671de5 0065-1433 HUMAN OTC DRUG
Systane Balance propylene glycol EMULSION OPHTHALMIC 20100727
OTC MONOGRAPH FINAL part349 "Alcon Laboratories, Inc." PROPYLENE GLYCOL
0.06 mg/mL
0065-1750_0137bde7-f3a1-60dc-8198-1754c08df5c1 0065-1750 HUMAN PRESCRIPTI
ON DRUG ILEVRO nepafenac SUSPENSION OPHTHALMIC 20121220
NDA NDA203491 "Alcon Laboratories, Inc." NEPAFENAC 3
mg/mL "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compound
0065-1795_28488c7b-cf6a-4a03-916f-cc66b3afdc57 0065-1795 HUMAN PRESCRIPTI
0065-2800_2d721281-13c5-a3b6-742a-79251efc14c2 0065-2800 HUMAN PRESCRIPTI
ON DRUG IZBA travoprost SOLUTION OPHTHALMIC 20140602
NDA NDA204822 "Alcon Laboratories, Inc." TRAVOPROST 0.03
mg/mL "Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient]"
0065-4011_e4300e4b-b43d-f1fa-6860-1d87ebc9bfa8 0065-4011 HUMAN OTC DRUG
Zaditor ketotifen fumarate SOLUTION OPHTHALMIC 20121221
ANDA ANDA077200 "Alcon Laboratories, Inc." KETOTIFEN FUMARATE
0.35 mg/mL
0065-4013_48fc0ac4-6192-6fc8-90f8-97bb35aaa1a0 0065-4013 HUMAN PRESCRIPTI
ON DRUG VIGAMOX moxifloxacin hydrochloride SOLUTION OPHTHALM
." MOXIFLOXACIN HYDROCHLORIDE 5 mg/mL "Quinolone Antimicrobial
0065-4147_668bddfa-a083-d9a3-3823-818504c59e73 0065-4147 HUMAN PRESCRIPTI
ON DRUG SIMBRINZA brinzolamide/brimonidine tartrate SUSPENSI
ON/ DROPS OPHTHALMIC 20130501 NDA NDA204251
"Alcon Laboratories, Inc." BRIMONIDINE TARTRATE; BRINZOLAMIDE 2; 10
mg/mL; mg/mL "Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitor
s [MoA],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC]"
0065-8531_f89ae7a5-0aeb-4e66-b406-973eb90c48c3 0065-8531 HUMAN PRESCRIPTI
ON DRUG CIPRO HC ciprofloxacin hydrochloride and hydrocortisone SUSPENSI
ON AURICULAR (OTIC) 19990315 NDA NDA020805
"Alcon Laboratories, Inc." CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE
2; 10 mg/mL; mg/mL "Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingr
edient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]"
0065-9240_983dd12c-2fb5-48cc-a954-5f61c18861e0 0065-9240 HUMAN PRESCRIPTI
ON DRUG DUREZOL DUREZOL EMULSION OPHTHALMIC 20110125
NDA NDA022212 "Alcon Laboratories, Inc." DIFLUPREDNATE 0.5
mg/mL
0998-0016_5655c4cf-de99-431a-96e1-30e8a1bd657e 0998-0016 HUMAN PRESCRIPTI
ON DRUG Alcaine proparacaine hydrochloride SOLUTION OPHTHALM
IC 19731019 ANDA ANDA080027 "Alcon Laboratories, Inc
." PROPARACAINE HYDROCHLORIDE 5 mg/mL "Local Anesthesia [PE],L
ocal Anesthetic [EPC]"
0998-0203_fb16671e-a0d5-88d6-dc8f-fd78e24be302 0998-0203 HUMAN PRESCRIPTI
ON DRUG ISOPTO CARPINE pilocarpine hydrochloride SOLUTION
ies, Inc." PILOCARPINE HYDROCHLORIDE 10 mg/mL "Cholinergic Ago
nists [MoA],Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [
EPC]"
EPC]"
EPC]"
0998-0223_35e46b99-7858-7e94-9e55-abce25b57a28 0998-0223 HUMAN PRESCRIPTI
ON DRUG Isopto Carbachol carbachol SOLUTION OPHTHALM
ies, Inc." CARBACHOL 15 mg/mL "Cholinergic Agonists [MoA],Chol
inergic Receptor Agonist [EPC]"
0998-0225_35e46b99-7858-7e94-9e55-abce25b57a28 0998-0225 HUMAN PRESCRIPTI
ON DRUG Isopto Carbachol carbachol SOLUTION OPHTHALM
ies, Inc." CARBACHOL 30 mg/mL "Cholinergic Agonists [MoA],Chol
inergic Receptor Agonist [EPC]"
0998-0303_3870b0cd-09ce-c48b-eea1-4666b1cd7a12 0998-0303 HUMAN PRESCRIPTI
ON DRUG Isopto Atropine atropine sulfate SOLUTION OPHTHALM
ies, Inc." ATROPINE SULFATE 10 mg/mL "Anticholinergic [EPC],C
holinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic
Muscarinic Antagonists [MoA]"
0998-0311_ef0317d3-49c1-5afa-7edd-1aad10a20235 0998-0311 HUMAN PRESCRIPTI
ON DRUG Isopto Homatropine homatropine hydrobromide SOLUTION
aboratories, Inc." HOMATROPINE HYDROBROMIDE 20 mg/mL "Choline
rgic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA]"
0998-0315_ef0317d3-49c1-5afa-7edd-1aad10a20235 0998-0315 HUMAN PRESCRIPTI
ON DRUG Isopto Homatropine homatropine hydrobromide SOLUTION
aboratories, Inc." HOMATROPINE HYDROBROMIDE 50 mg/mL "Choline
rgic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA]"
0998-0331_04b3b2ab-e575-0b38-e2dd-8e7627f58894 0998-0331 HUMAN PRESCRIPTI
ON DRUG Isopto Hyoscine scopolamine hydrobromide SOLUTION
aboratories, Inc." SCOPOLAMINE HYDROBROMIDE 2.5 mg/mL "Anticho
linergic [EPC],Cholinergic Antagonists [MoA]"
0998-0355_0d4f4a2e-eb00-4c65-b3fa-baf5738d468d 0998-0355 HUMAN PRESCRIPTI
ON DRUG Mydriacyl tropicamide SOLUTION OPHTHALMIC
19590401 ANDA ANDA084306 "Alcon Laboratories, Inc."
MoA]"
0998-0615_0e2252b9-6aa1-42ff-b0b0-bac1088feb03 0998-0615 HUMAN PRESCRIPTI
ON DRUG Maxidex dexamethasone SUSPENSION OPHTHALMIC 19660515
NDA NDA013422 "Alcon Laboratories, Inc." DEXAMETHASONE 1
0998-0630_d114106c-3e46-4870-9d7b-2260ca28229f 0998-0630 HUMAN PRESCRIPTI
ON DRUG Maxitrol "neomycin sulfate, polymyxin b sulfate and dexam
ethasone" SUSPENSION OPHTHALMIC 19641115 NDA
NDA050023 "Alcon Laboratories, Inc." DEXAMETHASONE; NEOMYCIN SULFATE;
POLYMYXIN B SULFATE 1; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL "Aminogl
ycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-clas
s Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Cort
icosteroid Hormone Receptor Agonists [MoA]"
0065-0431_049b9fcf-0d61-4f1f-bd60-9b048600574e 0065-0431 HUMAN OTC DRUG
Systane polyethylene glycol 0.4% and propylene glycol 0.3% SOLUTION
Alcon Research Ltd POLYETHYLENE GLYCOL; PROPYLENE GLYCOL .4; .3 mL/mL; m
L/mL
0065-1432_5837e14a-3e32-462e-96a3-212b20cc11fa 0065-1432 HUMAN OTC DRUG
Systane ULTRA polyethylene glycol 0.4% and propylene glycol 0.3% SOLUTION
Alcon Research Ltd POLYETHYLENE GLYCOL; PROPYLENE GLYCOL .4; .3 mL/mL; m
L/mL
0065-0092_74dbab96-e810-471d-9130-4b7975153c76 0065-0092 HUMAN PRESCRIPTI
ON DRUG FLUORESCITE fluorescein sodium "INJECTION, SOLUTION"
OPHTHALMIC 19720915 NDA NDA021980 "Alcon, Inc."
FLUORESCEIN SODIUM 100 mg/mL "Diagnostic Dye [EPC],Dyes [MoA]"
0065-8533_2ea874af-d374-43cc-ae82-6f98084d8e45 0065-8533 HUMAN PRESCRIPTI
ON DRUG CIPRODEX ciprofloxacin and dexamethasone SUSPENSION
AURICULAR (OTIC) 20030815 NDA NDA021537 "Alcon,
Inc." CIPROFLOXACIN HYDROCHLORIDE; DEXAMETHASONE 3; 1 mg/mL; mg/mL
"Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient],Corticosteroid [
EPC],Corticosteroid Hormone Receptor Agonists [MoA]"
64024-968_5be1ef4b-7832-4b46-a136-964e87b08f3c 64024-968 HUMAN OTC DRUG
LACURA FOR MEN EXTREME BLAST Aluminum Zirconium Tetrachlorohydrex Gly
STICK TOPICAL 20101108 OTC MONOGRAPH FINAL part350 ALDI INC
ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 200 mg/g
64024-969_90a5a5db-3572-4977-bf81-b29e35f7a05b 64024-969 HUMAN OTC DRUG
LACURA BODY CARE SHOWER FRESH Aluminum Zirconium Tetrachlorohydrex Gly
64024-970_602de6c7-b1d8-4a5a-beac-d5083a8ab04d 64024-970 HUMAN OTC DRUG
LACURA BODY CARE POWDER FRESH Aluminum Zirconium Tetrachlorohydrex Gly
64024-100_7fdb7736-61c7-420f-a790-0a4af934f7f2 64024-100 HUMAN OTC DRUG
Source Antibacterial Foaming Hand Original Triclosan LIQUID
TOPICAL 20130104 OTC MONOGRAPH NOT FINAL part333A Aldi Inc
. TRICLOSAN 0.46 mg/mL
64024-175_4dca678a-68cc-4bf2-9bf4-84b9fe77e98b 64024-175 HUMAN OTC DRUG
Extra Strength Headache Relief Acetaminophen TABLET ORAL 19930402
OTC MONOGRAPH NOT FINAL part343 ALDI INC. ACETAMINOPHEN 500 mg/1
64024-190_3635475f-c628-4061-80a1-3289e53d2123 64024-190 HUMAN OTC DRUG
Allergy Relief Diphenhydramine HCl CAPSULE ORAL 19900315
OTC MONOGRAPH FINAL part336 ALDI INC. DIPHENHYDRAMINE HYDROCHLORIDE
25 mg/1
64024-484_a6d788ad-af43-4b3a-ac68-5646cd5096a7 64024-484 HUMAN OTC DRUG
welby health acetaminophen Acetaminophen TABLET ORAL 19910812
OTC MONOGRAPH NOT FINAL part343 "Aldi, Inc" ACETAMINOPHEN 500 mg/1
64024-489_7b64c82f-fb4d-4511-894a-db4263405c49 64024-489 HUMAN OTC DRUG
welby health antacid Calcium carbonate "TABLET, CHEWABLE"
ORAL 20021023 OTC MONOGRAPH FINAL part331 "Aldi, Inc"
CALCIUM CARBONATE 750 mg/1
64024-604_6b2bba5a-2db7-488d-a773-f0fc72b05f47 64024-604 HUMAN OTC DRUG
welby health ibuprofen Ibuprofen TABLET ORAL 19930601
ANDA ANDA072096 "Aldi, Inc" IBUPROFEN 200 mg/1
64024-612_f3c586bc-c185-4037-b2c4-7b7db1ddaf55 64024-612 HUMAN OTC DRUG
Welby health allergy relief Loratadine TABLET ORAL 20070412
ANDA ANDA076301 "Aldi, Inc" LORATADINE 10 mg/1
64024-685_e58a0d1d-4ede-499a-9b3f-e51b61498b8e 64024-685 HUMAN OTC DRUG
welby health ibuprofen Ibuprofen LIQUID ORAL 20091209
ANDA ANDA074937 "Aldi, Inc" IBUPROFEN 100 mg/5mL
64024-962_7617df66-e042-48fe-bebe-76e85683e223 64024-962 HUMAN OTC DRUG
Foaming Hand Wash Triclosan 0.46% LIQUID TOPICAL 20140213
OTC MONOGRAPH NOT FINAL part333A "Aldi, Inc" TRICLOSAN 0.46
mg/mL
68411-4057_ac196ff8-98ae-4e74-a33f-a4fabdd56ca7 68411-4057 HUMAN OTC DRUG
Minus-Sol Facial Sun Protection Sunscreen Broad Spectrum SPF 30 Plus White
"OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE" CREAM TOPICAL 20120322
OTC MONOGRAPH NOT FINAL part352 Aledian Corporation OCTINOXATE; TITANIUM DIO
XIDE; ZINC OXIDE 4; 2; 5 g/100g; g/100g; g/100g
68411-4058_3367a078-fe41-4de6-9310-35dc25d24e70 68411-4058 HUMAN OTC DRUG
Minus-Sol Facial Sun Protection Sunscreen Broad Spectrum SPF 30 Plus Ivory
"OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE" CREAM TOPICAL 20120322
OTC MONOGRAPH NOT FINAL part352 Aledian Corporation OCTINOXATE; TITANIUM DIO
XIDE; ZINC OXIDE 4; 5; 5 g/100g; g/100g; g/100g
11110-0001_a0bd0816-f284-4be7-9b1c-35a1c9fdb763 11110-0001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS Alegent Health OXYGEN 99 L/100L
46708-019_a0891a32-105b-48bc-a246-5e179d2e7fa1 46708-019 HUMAN PRESCRIPTI
ON DRUG MEPROBAMATE MEPROBAMATE TABLET ORAL 20130723
ANDA ANDA090122 Alembic Pharmaceuticals Limited MEPROBAMATE 200
mg/1 CIV
46708-020_a0891a32-105b-48bc-a246-5e179d2e7fa1 46708-020 HUMAN PRESCRIPTI
ON DRUG MEPROBAMATE MEPROBAMATE TABLET ORAL 20130723
ANDA ANDA090122 Alembic Pharmaceuticals Limited MEPROBAMATE 400
mg/1 CIV
46708-025_31f3c720-1597-4d43-9296-33017b90b15f 46708-025 HUMAN PRESCRIPTI
ON DRUG Theophylline Theophylline "TABLET, EXTENDED RELEASE"
ORAL 20101101 ANDA ANDA090430 Alembic Pharmaceuticals
Limited THEOPHYLLINE ANHYDROUS 300 mg/1 "Methylxanthine [EPC],Xanthines
46708-026_31f3c720-1597-4d43-9296-33017b90b15f 46708-026 HUMAN PRESCRIPTI
ORAL 20101101 ANDA ANDA090430 Alembic Pharmaceuticals
Limited THEOPHYLLINE ANHYDROUS 450 mg/1 "Methylxanthine [EPC],Xanthines
46708-030_9a25f575-09ab-4d32-b73e-5426f08c00c4 46708-030 HUMAN PRESCRIPTI
ON DRUG ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE
Alembic Pharmaceuticals Limited ROPINIROLE HYDROCHLORIDE 0.25 mg/1
"Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]"
Alembic Pharmaceuticals Limited ROPINIROLE HYDROCHLORIDE 0.5 mg/1
Alembic Pharmaceuticals Limited ROPINIROLE HYDROCHLORIDE 1 mg/1
46708-087_bbf22268-86af-41ca-b665-b9b185b57611 46708-087 HUMAN PRESCRIPTI
ON DRUG Telmisartan Telmisartan TABLET ORAL 20130306
ANDA ANDA202130 Alembic Pharmaceuticals Limited TELMISARTAN 20
mg/1 "Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker
[EPC]"
[EPC]"
[EPC]"
46708-092_6ca3acff-fe7c-483a-a728-39e06c279dbb 46708-092 HUMAN PRESCRIPTI
ON DRUG Donepezil Hydrochloride 5 mg Donepezil Hydrochloride "TABLET, FILM CO
ATED" ORAL 20130304 ANDA ANDA201724 Alembic Pharmace
uticals Limited DONEPEZIL HYDROCHLORIDE 5 mg/1 "Cholinesterase Inhibito
46708-093_6ca3acff-fe7c-483a-a728-39e06c279dbb 46708-093 HUMAN PRESCRIPTI
ON DRUG Donepezil Hydrochloride 5 mg Donepezil Hydrochloride "TABLET, FILM CO
ATED" ORAL 20130219 ANDA ANDA201724 Alembic Pharmace
uticals Limited DONEPEZIL HYDROCHLORIDE 10 mg/1 "Cholinesterase Inhibito
46708-112_8c853cd1-de72-4897-ba6d-692bb096eb34 46708-112 HUMAN PRESCRIPTI
ON DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET ORAL
20130425 ANDA ANDA202871 Alembic Pharmaceuticals Limited
METOPROLOL TARTRATE 25 mg/1 "Adrenergic beta-Antagonists [MoA],beta-
Adrenergic Blocker [EPC]"
46708-128_53df64fc-7fec-4c14-8fe3-c6a128be814a 46708-128 HUMAN PRESCRIPTI
ON DRUG Duloxetine Hydrochloride 20 mg Duloxetine "CAPSULE, DELAYE
D RELEASE" ORAL 20140609 ANDA ANDA202949 Alembic
Pharmaceuticals Limited DULOXETINE HYDROCHLORIDE 20 mg/1 "Norepin
ephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor
[EPC],Serotonin Uptake Inhibitors [MoA]"
46708-209_5b476740-e3f0-4f68-b07c-cd9eb2fa27ca 46708-209 HUMAN PRESCRIPTI
ON DRUG Telmisartan and Hydrochlorothiazide 40 mg/12.5 mg Telmisartan and
Hydrochlorothiazide TABLET ORAL 20140314 ANDA ANDA2030
10 Alembic Pharmaceuticals Limited HYDROCHLOROTHIAZIDE; TELMISARTAN
12.5; 40 mg/1; mg/1 "Angiotensin 2 Receptor Antagonists [MoA],Angiot
ON DRUG Telmisartan and Hydrochlorothiazide 80 mg/12.5 mg Telmisartan and
ON DRUG Telmisartan and Hydrochlorothiazide 80 mg/25 mg Telmisartan and
25; 80 mg/1; mg/1 "Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2
Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides
63054-0123_297624b2-c1db-47bf-bf2a-584e65577298 63054-0123 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS "Alert Respiratory Services, Inc." OXYGEN
99 L/100L
68776-1001_25d2009c-2f79-4de4-9670-2f2b6a29eed1 68776-1001 HUMAN OTC DRUG
Wyandotte Sanifect E3 ALCOHOL LOTION TOPICAL 20061001
OTC MONOGRAPH NOT FINAL part333E "Alex C. Fergusson, Inc." ALCOHOL
60.1 L/100L
68776-1003_57b676c7-a336-4def-871e-2b3ebb19348a 68776-1003 HUMAN OTC DRUG
WYANDOTTE SANIFECT E3-NA BENZALKONIUM CHLORIDE LOTION TOPICAL
20110101 OTC MONOGRAPH NOT FINAL part333A "Alex C. Ferguss
on, Inc." BENZALKONIUM CHLORIDE 99468.4 g/100L
68776-1004_6af3eca5-f342-4442-b497-b78d380daa81 68776-1004 HUMAN OTC DRUG
WYANDOTTE SANIFECT E2 BENZALKONIUM CHLORIDE LIQUID TOPICAL 20121101
OTC MONOGRAPH NOT FINAL part333A "Alex C. Fergusson, Inc." BENZALKO
NIUM CHLORIDE 268575.42 mg/208198mL
68776-1005_abcebd68-bb93-42bd-826b-7968c14f55f4 68776-1005 HUMAN OTC DRUG
WYANDOTTE SANIFECT FOAM-E II CHLOROXYLENOL LIQUID TOPICAL 20090106
OTC MONOGRAPH NOT FINAL part333A "Alex C. Fergusson, Inc." CHLOROXY
LENOL 2081980 mg/208198mL
68776-1006_8076d92c-76dd-4da7-b3e5-51a0210cca43 68776-1006 HUMAN OTC DRUG
AFCO 5512 BENZALKONIUM CHLORIDE LIQUID TOPICAL 20121101
OTC MONOGRAPH NOT FINAL part333A "Alex C. Fergusson, Inc." BENZALKO
NIUM CHLORIDE 1.29 mg/mL
25682-001_aa636788-877e-4146-a760-cf4ff8c9b788 25682-001 HUMAN PRESCRIPTI
ON DRUG Soliris eculizumab "INJECTION, SOLUTION, CONCENTRATE"
INTRAVENOUS 20070402 BLA BLA125166 Alexion Pharmace
uticals Inc. ECULIZUMAB 300 mg/30mL "Complement Inhibitor [EPC],Comp
lement Inhibitors [MoA]"
50488-0901_0df9abaf-3997-4dde-8003-ae3d8d07cf39 50488-0901 HUMAN OTC DRUG
Laxacin Docusate sodium and sennosides TABLET ORAL 20111001
OTC MONOGRAPH NOT FINAL part334 Alexso Inc DOCUSATE SODIUM; SENNOSIDES A AN
D B 50; 8.6 mg/1; mg/1
50488-1201_3f541c7c-e6d6-47cb-8406-865bc61f8c5d 50488-1201 HUMAN OTC DRUG
Limencin Patch Lidocaine Hydrochloride-Menthol PATCH TOPICAL 20140801
OTC MONOGRAPH NOT FINAL part348 Alexso Inc LIDOCAINE HYDROCHLORIDE; MENTHOL
40; 40 mg/1; mg/1
50488-1001_100ceb76-8ebe-437b-a8de-37cc76ece9bb 50488-1001 HUMAN OTC DRUG
Terocin "Lidocaine, Menthol" PATCH TOPICAL 20130501
OTC MONOGRAPH NOT FINAL part348 Alexso Inc. LIDOCAINE; MENTHOL 600; 600
mg/1; mg/1
50488-1129_5dbd5fc0-a27e-4979-aca7-28f73096fd5f 50488-1129 HUMAN OTC DRUG
New Terocin "Methyl Salicylate, Capsaicin, and Menthol" LOTION
TOPICAL 20130313 OTC MONOGRAPH NOT FINAL part348 Alexso Inc.
CAPSAICIN; MENTHOL; METHYL SALICYLATE .025; 10; 25 g/100mL; g/100mL; g/100m
L
50488-1231_85066887-44d0-4a4a-adee-670073e4b22c 50488-1231 HUMAN OTC DRUG
Terocin "Methyl Salicylate, Capsaicin, Menthol and Lidocaine Hydrochlori
de" LOTION TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part348
Alexso Inc. CAPSAICIN; LIDOCAINE HYDROCHLORIDE; MENTHOL; METHYL SALICYLATE
.025; 2.5; 10; 25 g/100mL; g/100mL; g/100mL; g/100mL
50488-2626_6277062d-9937-476e-8e48-685bcef533d0 50488-2626 HUMAN PRESCRIPTI
ON DRUG Morcin Acontium Napellus CREAM TOPICAL 20140320
UNAPPROVED HOMEOPATHIC "Alexso, Inc" ACHILLEA MILLEFOLIUM; ACONITUM N
APELLUS; ARNICA MONTANA; BELLADONNA LEAF; BELLIS PERENNIS; CALENDULA OFFICINALIS
FLOWER; COLCHICUM AUTUMNALE FLOWER; ECHINACEA ANGUSTIFOLIA; ECHINACEA PURPUREA;
HAMAMELIS VIRGINIANA WHOLE; HYPERICUM PERFORATUM; MATRICARIA RECUTITA 6; 6; 6;
6; 6; 5; 6; 4; 6; 6; 6; 6 [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]
/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [h
p_X]/120mL; [hp_X]/120mL; [hp_X]/120mL
49371-015_cbdbc8ef-91cc-44d8-a11c-1432d923837c 49371-015 HUMAN OTC DRUG
Pier 1 Imports Blueberry Parfait Anti-Bacterial Hand Sanitizer ALCOHOL
LIQUID TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 ALILY (Z
HANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g
49371-016_1c46a615-7e92-4c1d-af2a-e108ddaced8d 49371-016 HUMAN OTC DRUG
Pier 1 Imports Cherry Anti-Bacterial Hand Sanitizer Alcohol LIQUID
TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU
) BATH PRODUCTS LTD. ALCOHOL 62 g/100g
49371-017_ecef821f-08e2-46ba-8b2b-c3babccf0c26 49371-017 HUMAN OTC DRUG
Pier 1 Imports Lavender Vanilla Anti-Bacterial Hand Sanitizer Pier 1 Imports
Hand Sanitizer LIQUID TOPICAL 20100220 OTC MONOGRAPH NOT FINAL
part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g
49371-018_da3a1bbf-7260-4c23-8902-3cd33536427f 49371-018 HUMAN OTC DRUG
Pier 1 Imports Lily blossom Anti-Bacterial Hand Sanitizer Alcohol
49371-019_715ddd48-f14b-4282-992f-b31ed82e418e 49371-019 HUMAN OTC DRUG
Pier 1 Imports Melon and Mint Anti-Bacterial Hand Sanitizer Alcohol
49371-020_3d3c09cf-7bf4-4a10-a2c0-b8fc98c834c7 49371-020 HUMAN OTC DRUG
Pier 1 Imports Passion Fruit Anti-Bacterial Hand Sanitizer ALCOHOL
49371-021_6b751edb-e42b-4da2-88fa-c904b130ec72 49371-021 HUMAN OTC DRUG
Wild Strawberry Anti-Bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL
20100220 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH P
RODUCTS LTD. ALCOHOL 62 g/100g
49371-022_36ed9405-5b62-45ea-ad2f-82f2d3e0fb7e 49371-022 HUMAN OTC DRUG
Peach Mango Anti-Bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL
49371-023_6709c311-85cd-4c38-935e-eb76ad1e6d29 49371-023 HUMAN OTC DRUG
Coconut Lime Anti-Bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL
49371-024_9fbf3e68-9a84-4b24-9926-724c9ba4539f 49371-024 HUMAN OTC DRUG
Mandarin Orange Anti-Bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL
49371-025_2b032c9b-765a-458f-a383-15a36660d175 49371-025 HUMAN OTC DRUG
Pier 1 Imports Crisp Bamboo Anti-Bacterial Hand Sanitizer ALCOHOL
49371-026_3f1b7dd3-e565-41bd-895e-0f18849f6ac2 49371-026 HUMAN OTC DRUG
Pier 1 Imports Ginger Peach Anti-Bacterial Hand Sanitizer ALCOHOL
49371-027_4361f570-3903-430f-a086-bbf0310e488c 49371-027 HUMAN OTC DRUG
Pier 1 Imports Lavender Anti-Bacterial Hand Sanitizer ALCOHOL LIQUID
49371-028_a66ee6bb-c3ef-4383-8724-e0fc0329ac21 49371-028 HUMAN OTC DRUG
Pier 1 Imports Iced Cookie Anti-Bacterial Hand Sanitizer ALCOHOL
49371-030_24b3b68e-9e1d-4bee-9c8a-c7a01b4cb642 49371-030 HUMAN OTC DRUG
Pier 1 Imports Sugared Plum Anti-Bacterial Hand Sanitizer ALCOHOL
49371-031_85260ee1-f2be-4671-b1de-f5333b42a686 49371-031 HUMAN OTC DRUG
Pier 1 Imports Vanilla Mint Anti-Bacterial Hand Sanitizer ALCOHOL
49371-032_6985404e-5215-4208-a053-9590e12236b3 49371-032 HUMAN OTC DRUG
Healing Water Amber Flower Anti-Bacterial Hand Sanitizer ALCOHOL
49371-033_5cdd43ba-b909-4606-b2a0-f87149e84e60 49371-033 HUMAN OTC DRUG
Healing Waters Vanilla Orchid Anti-Bacterial Hand Sanitizer ALCOHOL
49371-034_2e9aa2df-d3b6-4527-ae44-ee0fe1fddce1 49371-034 HUMAN OTC DRUG
Dots Apple Cinnamon Anti-Bacterial Hand Sanitizer Alcohol LIQUID
49371-035_619e7ed6-491d-4863-a12b-b66f61b2eeb4 49371-035 HUMAN OTC DRUG
Dots Asian Spice Anti-Bacterial Hand Sanitizer Alcohol LIQUID TOPICAL
49371-036_e8be399f-69a5-41eb-987e-531ac530b69d 49371-036 HUMAN OTC DRUG
Lavender Vanilla Anti-Bacterial Hand Sanitizer Alcohol LIQUID TOPICAL
49371-037_2db88a46-707d-4e5d-bd20-c321e98cd9d6 49371-037 HUMAN OTC DRUG
Wild Strawberry Anti-Bacterial Hand Sanitizer Alcohol LIQUID TOPICAL
49371-038_abce3d3b-c12e-4313-9d27-79bc961ff771 49371-038 HUMAN OTC DRUG
Love and Beauty Melon and Mint Anti-Bacterial Hand Sanitizer Alcohol
49371-039_54ecb3f0-5b0a-4d51-9cf1-d45aa92faddf 49371-039 HUMAN OTC DRUG
Love and Beauty Peach Mango Anti-Bacterial Hand Sanitizer Alcohol
49371-040_b38e4d1d-4194-47ea-be1f-6ddd4bbbf25c 49371-040 HUMAN OTC DRUG
Rue 21 Asian Spice Anti-Bacterial Hand Sanitizer Alcohol LIQUID
49371-041_bee9a57a-7599-43c4-9bc5-34c67ef5ebf3 49371-041 HUMAN OTC DRUG
Rue21 Coco Breeze Anti-Bacterial Hand Sanitizer Alcohol LIQUID TOPICAL
49371-042_7a446ab9-2daf-4180-bacf-3042d6ec70ba 49371-042 HUMAN OTC DRUG
Rue21 Island Fruits Anti-Bacterial Hand Sanitizer Alcohol LIQUID
49371-043_c644b1a4-67b6-43a6-9229-bb08162f0cdf 49371-043 HUMAN OTC DRUG
Rue21 Ocean Anti-Bacterial Hand Sanitizer Alcohol LIQUID TOPICAL
49371-044_8c686337-2236-4bae-bc4e-d09de3133ee6 49371-044 HUMAN OTC DRUG
Aromafields Jasmine Scented Anti-Bacterial Hand Triclosan LOTION
) BATH PRODUCTS LTD. TRICLOSAN 0.15 g/100g
49371-045_35006f88-a5bc-4633-ab70-9cafa6f41301 49371-045 HUMAN OTC DRUG
Aromafields Lavender Scented Anti-Bacterial Hand Triclosan
LOTION TOPICAL 20100620 OTC MONOGRAPH NOT FINAL part333 ALILY (Z
HANGZHOU) BATH PRODUCTS LTD. TRICLOSAN 0.15 g/100g
49371-046_0bbf7e17-819b-44e5-9d17-96a9ca3401a7 49371-046 HUMAN OTC DRUG
Aromafields Plumeria Scented Anti-Bacterial Hand Triclosan
49371-047_83d16199-e5b8-4aa3-abdc-1da530b74238 49371-047 HUMAN OTC DRUG
Aromafields Tiger Lily Scented Anti-Bacterial Hand Triclosan
52709-0801_0cbfb80a-db5c-45ce-b79d-80fde2ba8355 52709-0801 NON-STANDARDIZED
ALLERGENIC HONEY BEE VENOM APIS MELLIFERA VENOM "INJECTION, POWD
ER, LYOPHILIZED, FOR SOLUTION" SUBCUTANEOUS 19921120 BLA
BLA103969 ALK-Abello A S APIS MELLIFERA VENOM 120 ug/1
ALLERGENIC EASTERN YELLOWJACKET VENOM PROTEIN VESPULA MACULIFR
ONS VENOM PROTEIN "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION" SUBCUTAN
EOUS 19921120 BLA BLA103974 ALK-Abello A S VESPULA
MACULIFRONS VENOM PROTEIN 120 ug/1 "Standardized Insect Venom Aller
genic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE]
,Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chem
ical/Ingredient]"
ALLERGENIC YELLOW HORNET VENOM PROTEIN DOLICHOVESPULA ARENARIA
VENOM PROTEIN "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION" SUBCUTANEOUS
19921120 BLA BLA103973 ALK-Abello A S DOLICHOVESPULA A
RENARIA VENOM PROTEIN 120 ug/1 "Standardized Insect Venom Allergenic Ex
tract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increas
ed IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ing
redient]"
ALLERGENIC WHITE FACED HORNET VENOM PROTEIN DOLICHOVESPULA M
ACULATA VENOM PROTEIN "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION" SUBCUTAN
EOUS 19921120 BLA BLA103972 ALK-Abello A S DOLICHOV
ESPULA MACULATA VENOM PROTEIN 120 ug/1 "Standardized Insect Venom Aller
,Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chem
ical/Ingredient]"
ALLERGENIC COMMON PAPER WASP VENOM PROTEIN POLISTES FUSCATUS VENOM
PROTEIN "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION" SUBCUTANEOUS 19921120
BLA BLA103971 ALK-Abello A S POLISTES FUSCATUS VENOM PROTEIN 120
ug/1 "Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine
Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Veno
ms [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
ALLERGENIC Hymenoptera Venom Diagnostic Hymenoptera Venom Diagno
stic KIT 19921120 BLA BLA123456 ALK-Abel
lo A S
0268-0001_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0001 NON-STANDARDIZED
ALLERGENIC HOUSE DUST House Dust "INJECTION, SOLUTION"
SUBCUTANEOUS 19650101 BLA BLA103753 "ALK-Abello, Inc
." HOUSE DUST 1000 [PNU]/mL "Non-Standardized House Dust All
ergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [P
E],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Che
mical/Ingredient]"
mical/Ingredient]"
mical/Ingredient]"
mical/Ingredient]"
mical/Ingredient]"
mical/Ingredient]"
mical/Ingredient]"
mical/Ingredient]"
." HOUSE DUST 0.1 g/mL "Non-Standardized House Dust Allergenic
Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Incre
ased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/In
gredient]"
mical/Ingredient]"
mical/Ingredient]"
gredient]"
gredient]"
0268-0021_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0021 HUMAN PRESCRIPTI
ON DRUG CENTER-AL - ACACIA LONGIFOLIA POLLEN Allergenic Extracts Alum
Precipitated "INJECTION, SUSPENSION" SUBCUTANEOUS 19750115
BLA BLA103753 "ALK-Abello, Inc." ACACIA LONGIFOLIA POLLEN
10000 [PNU]/mL "Non-Standardized Pollen Allergenic Extract [EPC],Increa
sed Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production
[PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
ON DRUG CENTER-AL - ALNUS INCANA SSP. RUGOSA POLLEN Allergenic Extra
cts Alum Precipitated "INJECTION, SUSPENSION" SUBCUTANEOUS 19750115
BLA BLA103753 "ALK-Abello, Inc." ALNUS INCANA SSP. RUGOSA POLLEN
ON DRUG CENTER-AL - FRAXINUS AMERICANA POLLEN Allergenic Extracts Alum
BLA BLA103753 "ALK-Abello, Inc." FRAXINUS AMERICANA POLLEN
ON DRUG CENTER-AL - PASPALUM NOTATUM POLLEN Allergenic Extracts Alum
BLA BLA103753 "ALK-Abello, Inc." PASPALUM NOTATUM POLLEN 20000
[PNU]/mL "Non-Standardized Pollen Allergenic Extract [EPC],Increased Hist
amine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pol
len [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
ON DRUG CENTER-AL - PASPALUM NOTATUM POLLEN Allergenic Extracts Alum
BLA BLA103753 "ALK-Abello, Inc." PASPALUM NOTATUM POLLEN 10000
ON DRUG CENTER-AL - FAGUS GRANDIFOLIA POLLEN Allergenic Extracts Alum
BLA BLA103753 "ALK-Abello, Inc." FAGUS GRANDIFOLIA POLLEN
ON DRUG CENTER-AL - CYNODON DACTYLON POLLEN Allergenic Extracts Alum
BLA BLA103753 "ALK-Abello, Inc." CYNODON DACTYLON POLLEN 10000
[PNU]/mL "Standardized Pollen Allergenic Extract [EPC],Increased Histamin
e Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen
[Chemical/Ingredient],Allergens [Chemical/Ingredient]"
ON DRUG CENTER-AL - CYNODON DACTYLON POLLEN Allergenic Extracts Alum
BLA BLA103753 "ALK-Abello, Inc." CYNODON DACTYLON POLLEN 20000
ON DRUG CENTER-AL - BETULA LENTA POLLEN Allergenic Extracts Alum Precipi
tated "INJECTION, SUSPENSION" SUBCUTANEOUS 19750115 BLA
BLA103753 "ALK-Abello, Inc." BETULA LENTA POLLEN 10000 [PNU]/mL
"Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [P
E],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/In
gredient],Allergens [Chemical/Ingredient]"
ON DRUG CENTER-AL - POA ANNUA POLLEN Allergenic Extracts Alum Precipi
BLA103753 "ALK-Abello, Inc." POA ANNUA POLLEN 20000 [PNU]/mL
ON DRUG CENTER-AL - ACER NEGUNDO POLLEN Allergenic Extracts Alum Precipi
BLA103753 "ALK-Abello, Inc." ACER NEGUNDO POLLEN 10000 [PNU]/mL
ON DRUG CENTER-AL - BROMUS INERMIS POLLEN Allergenic Extracts Alum
BLA BLA103753 "ALK-Abello, Inc." BROMUS INERMIS POLLEN 20000
len [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Polle
n Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immuni
ty [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Ch
emical/Ingredient]"
ON DRUG CENTER-AL - XANTHIUM STRUMARIUM POLLEN Allergenic Extracts Alum
BLA BLA103753 "ALK-Abello, Inc." XANTHIUM STRUMARIUM POLLEN
ON DRUG CENTER-AL - XANTHIUM STRUMARIUM POLLEN Allergenic Extracts Alum
BLA BLA103753 "ALK-Abello, Inc." XANTHIUM STRUMARIUM POLLEN
ON DRUG CENTER-AL - ZEA MAYS POLLEN Allergenic Extracts Alum Precipi
BLA103753 "ALK-Abello, Inc." ZEA MAYS POLLEN 10000 [PNU]/mL
ON DRUG CENTER-AL - POPULUS DELTOIDES SSP. MONILIFERA POLLEN Allergen
ic Extracts Alum Precipitated "INJECTION, SUSPENSION" SUBCUTANEOUS 19750115
BLA BLA103753 "ALK-Abello, Inc." POPULUS DELTOIDES SSP. MONILIFER
A POLLEN 10000 [PNU]/mL "Non-Standardized Pollen Allergenic Extr
act [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased
IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient
]"
ON DRUG CENTER-AL - RUMEX ACETOSELLA POLLEN Allergenic Extracts Alum
BLA BLA103753 "ALK-Abello, Inc." RUMEX ACETOSELLA POLLEN 10000
[PNU]/mL "Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated
Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increas
ed Histamine Release [PE],Allergens [Chemical/Ingredient]"
ON DRUG CENTER-AL - RUMEX CRISPUS POLLEN Allergenic Extracts Alum
BLA BLA103753 "ALK-Abello, Inc." RUMEX CRISPUS POLLEN 10000
ON DRUG CENTER-AL - ULMUS AMERICANA POLLEN Allergenic Extracts Alum
BLA BLA103753 "ALK-Abello, Inc." ULMUS AMERICANA POLLEN 10000
ON DRUG CENTER-AL - ULMUS PUMILA POLLEN Allergenic Extracts Alum Precipi
BLA103753 "ALK-Abello, Inc." ULMUS PUMILA POLLEN 10000 [PNU]/mL
ON DRUG CENTER-AL - CORYLUS AMERICANA POLLEN Allergenic Extracts Alum
BLA BLA103753 "ALK-Abello, Inc." CORYLUS AMERICANA POLLEN
ON DRUG CENTER-AL - CARYA OVATA POLLEN Allergenic Extracts Alum Precipi
BLA103753 "ALK-Abello, Inc." CARYA OVATA POLLEN 10000 [PNU]/mL
ON DRUG CENTER-AL - HOUSE DUST Allergenic Extracts Alum Precipitated
"INJECTION, SUSPENSION" SUBCUTANEOUS 19750115 BLA BLA10375
3 "ALK-Abello, Inc." HOUSE DUST 10000 [PNU]/mL "Non-Sta
ndardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],C
ell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ing
redient],House Dust [Chemical/Ingredient]"
ON DRUG CENTER-AL - SORGHUM HALEPENSE POLLEN Allergenic Extracts Alum
BLA BLA103753 "ALK-Abello, Inc." SORGHUM HALEPENSE POLLEN
ON DRUG CENTER-AL - POA PRATENSIS POLLEN Allergenic Extracts Alum
BLA BLA103753 "ALK-Abello, Inc." POA PRATENSIS POLLEN 20000
ON DRUG CENTER-AL - POA PRATENSIS POLLEN Allergenic Extracts Alum
ON DRUG CENTER-AL - KOCHIA SCOPARIA POLLEN Allergenic Extracts Alum
BLA BLA103753 "ALK-Abello, Inc." KOCHIA SCOPARIA POLLEN 10000
ON DRUG CENTER-AL - CHENOPODIUM ALBUM POLLEN Allergenic Extracts Alum
BLA BLA103753 "ALK-Abello, Inc." CHENOPODIUM ALBUM POLLEN
ON DRUG CENTER-AL - ACER SACCHARUM POLLEN Allergenic Extracts Alum
BLA BLA103753 "ALK-Abello, Inc." ACER SACCHARUM POLLEN 10000
ON DRUG CENTER-AL - FESTUCA PRATENSIS POLLEN Allergenic Extracts Alum
BLA BLA103753 "ALK-Abello, Inc." FESTUCA PRATENSIS POLLEN
20000 [PNU]/mL "Standardized Pollen Allergenic Extract [EPC],Increased
Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE]
,Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
ON DRUG CENTER-AL - FESTUCA PRATENSIS POLLEN Allergenic Extracts Alum
ON DRUG CENTER-AL - PROSOPIS JULIFLORA POLLEN Allergenic Extracts Alum
BLA BLA103753 "ALK-Abello, Inc." PROSOPIS JULIFLORA POLLEN
ON DRUG CENTER-AL - ARTEMISIA VULGARIS POLLEN Allergenic Extracts Alum
BLA BLA103753 "ALK-Abello, Inc." ARTEMISIA VULGARIS POLLEN
sed Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredie
nt],Allergens [Chemical/Ingredient]"
ON DRUG CENTER-AL - MORUS RUBRA POLLEN Allergenic Extracts Alum Precipi
BLA103753 "ALK-Abello, Inc." MORUS RUBRA POLLEN 10000 [PNU]/mL
ON DRUG CENTER-AL - QUERCUS AGRIFOLIA POLLEN Allergenic Extracts Alum
BLA BLA103753 "ALK-Abello, Inc." QUERCUS AGRIFOLIA POLLEN
ON DRUG CENTER-AL - QUERCUS VIRGINIANA POLLEN Allergenic Extracts Alum
BLA BLA103753 "ALK-Abello, Inc." QUERCUS VIRGINIANA POLLEN
ON DRUG CENTER-AL - QUERCUS ALBA POLLEN Allergenic Extracts Alum Precipi
BLA103753 "ALK-Abello, Inc." QUERCUS ALBA POLLEN 10000 [PNU]/mL
ON DRUG CENTER-AL - AVENA SATIVA POLLEN Allergenic Extracts Alum Precipi
BLA103753 "ALK-Abello, Inc." AVENA SATIVA POLLEN 10000 [PNU]/mL
ON DRUG CENTER-AL - OLEA EUROPAEA POLLEN Allergenic Extracts Alum
BLA BLA103753 "ALK-Abello, Inc." OLEA EUROPAEA POLLEN 10000
ON DRUG CENTER-AL - DACTYLIS GLOMERATA POLLEN Allergenic Extracts Alum
BLA BLA103753 "ALK-Abello, Inc." DACTYLIS GLOMERATA POLLEN
ON DRUG CENTER-AL - CARYA ILLINOINENSIS POLLEN Allergenic Extracts Alum
BLA BLA103753 "ALK-Abello, Inc." CARYA ILLINOINENSIS POLLEN
ON DRUG CENTER-AL - AMARANTHUS RETROFLEXUS POLLEN Allergenic Extra
BLA BLA103753 "ALK-Abello, Inc." AMARANTHUS RETROFLEXUS POLLEN
ON DRUG CENTER-AL - AMARANTHUS RETROFLEXUS POLLEN Allergenic Extra
BLA BLA103753 "ALK-Abello, Inc." AMARANTHUS RETROFLEXUS POLLEN
ON DRUG CENTER-AL - PLANTAGO LANCEOLATA POLLEN Allergenic Extracts Alum
BLA BLA103753 "ALK-Abello, Inc." PLANTAGO LANCEOLATA POLLEN
ON DRUG CENTER-AL - POPULUS ALBA POLLEN Allergenic Extracts Alum Precipi
BLA103753 "ALK-Abello, Inc." POPULUS ALBA POLLEN 10000 [PNU]/mL
ON DRUG CENTER-AL - AMBROSIA ACANTHICARPA POLLEN Allergenic Extra
BLA BLA103753 "ALK-Abello, Inc." AMBROSIA ACANTHICARPA POLLEN
BLA BLA103753 "ALK-Abello, Inc." AMBROSIA ARTEMISIIFOLIA POLLEN
BLA BLA103753 "ALK-Abello, Inc." AMBROSIA ARTEMISIIFOLIA POLLEN
ON DRUG CENTER-AL - AMBROSIA TRIFIDA POLLEN Allergenic Extracts Alum
BLA BLA103753 "ALK-Abello, Inc." AMBROSIA TRIFIDA POLLEN 20000
amine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Alle
rgens [Chemical/Ingredient]"
ON DRUG CENTER-AL - AMBROSIA TRIFIDA POLLEN Allergenic Extracts Alum
BLA BLA103753 "ALK-Abello, Inc." AMBROSIA TRIFIDA POLLEN 10000
ON DRUG CENTER-AL - AMBROSIA PSILOSTACHYA POLLEN Allergenic Extra
BLA BLA103753 "ALK-Abello, Inc." AMBROSIA PSILOSTACHYA POLLEN
ON DRUG CENTER-AL - AGROSTIS GIGANTEA Allergenic Extracts Alum Precipi
BLA103753 "ALK-Abello, Inc." AGROSTIS GIGANTEA 20000 [PNU]/mL
ON DRUG CENTER-AL - SALSOLA KALI POLLEN Allergenic Extracts Alum Precipi
BLA103753 "ALK-Abello, Inc." SALSOLA KALI POLLEN 10000 [PNU]/mL
ON DRUG CENTER-AL - LOLIUM PERENNE POLLEN Allergenic Extracts Alum
BLA BLA103753 "ALK-Abello, Inc." LOLIUM PERENNE POLLEN 20000
ON DRUG CENTER-AL - LOLIUM PERENNE POLLEN Allergenic Extracts Alum
BLA BLA103753 "ALK-Abello, Inc." LOLIUM PERENNE POLLEN 10000
ON DRUG CENTER-AL - ARTEMISIA TRIDENTATA POLLEN Allergenic Extracts Alum
BLA BLA103753 "ALK-Abello, Inc." ARTEMISIA TRIDENTATA POLLEN
ON DRUG CENTER-AL - ATRIPLEX WRIGHTII POLLEN Allergenic Extracts Alum
BLA BLA103753 "ALK-Abello, Inc." ATRIPLEX WRIGHTII POLLEN
ON DRUG CENTER-AL - ATRIPLEX WRIGHTII POLLEN Allergenic Extracts Alum
BLA BLA103753 "ALK-Abello, Inc." ATRIPLEX WRIGHTII POLLEN
ON DRUG CENTER-AL - PLATANUS OCCIDENTALIS POLLEN Allergenic Extra
BLA BLA103753 "ALK-Abello, Inc." PLATANUS OCCIDENTALIS POLLEN
ON DRUG CENTER-AL - PLATANUS RACEMOSA POLLEN Allergenic Extracts Alum
BLA BLA103753 "ALK-Abello, Inc." PLATANUS RACEMOSA POLLEN
ON DRUG CENTER-AL - PHLEUM PRATENSE POLLEN Allergenic Extracts Alum
BLA BLA103753 "ALK-Abello, Inc." PHLEUM PRATENSE POLLEN 10000
ON DRUG CENTER-AL - PHLEUM PRATENSE POLLEN Allergenic Extracts Alum
BLA BLA103753 "ALK-Abello, Inc." PHLEUM PRATENSE POLLEN 20000
ON DRUG CENTER-AL - HOLCUS LANATUS POLLEN Allergenic Extracts Alum
BLA BLA103753 "ALK-Abello, Inc." HOLCUS LANATUS POLLEN 10000
emical/Ingredient]"
ON DRUG CENTER-AL - JUGLANS NIGRA POLLEN Allergenic Extracts Alum
BLA BLA103753 "ALK-Abello, Inc." JUGLANS NIGRA POLLEN 10000
ON DRUG CENTER-AL - JUGLANS CALIFORNICA POLLEN Allergenic Extracts Alum
BLA BLA103753 "ALK-Abello, Inc." JUGLANS CALIFORNICA POLLEN
10000 [PNU]/mL "Non-Standardized Pollen Allergenic Extract [EPC],Cell-m
ediated Immunity [PE],Increased IgG Production [PE],Increased Histamine Release
ON DRUG CENTER-AL - SALIX NIGRA POLLEN Allergenic Extracts Alum Precipi
BLA103753 "ALK-Abello, Inc." SALIX NIGRA POLLEN 10000 [PNU]/mL
0268-0247_28517fe7-35ea-4ed9-af4c-2800c890460e 0268-0247 HUMAN PRESCRIPTI
ON DRUG Histamine Positive Skin Test Control histamine phosphate
SOLUTION PERCUTANEOUS 19891023 BLA BLA103754
"ALK-Abello, Inc." HISTAMINE PHOSPHATE 2.75 mg/mL
0268-0248_28517fe7-35ea-4ed9-af4c-2800c890460e 0268-0248 HUMAN PRESCRIPTI
ON DRUG histamine positive skin test control histamine phosphate
"INJECTION, SOLUTION" SUBCUTANEOUS 19891023 BLA BLA10375
4 "ALK-Abello, Inc." HISTAMINE PHOSPHATE 0.275 mg/mL
0268-0268_55746080-edfc-4d38-9d49-85a4329bbd2c 0268-0268 HUMAN PRESCRIPTI
ON DRUG "Cat Pelt, Standardized" "Cat Pelt, Standardized"
1 "ALK-Abello, Inc." FELIS CATUS SKIN 10000 [BAU]/mL
"Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [
PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingr
edient],Allergens [Chemical/Ingredient]"
0268-0275_0fbc190d-80b9-4c94-b8dc-637ae1c75366 0268-0275 HUMAN PRESCRIPTI
ON DRUG Standardized Mite D. farinae Standardized Mite D. farinae
0 "ALK-Abello, Inc." DERMATOPHAGOIDES FARINAE 10000 [AU]/mL
"Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],C
ell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoi
des [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemi
cal/Ingredient]"
0 "ALK-Abello, Inc." DERMATOPHAGOIDES FARINAE 5000 [AU]/mL
cal/Ingredient]"
ON DRUG Standardized Mite D. pteronyssinus Standardized Mite D. pte
ronyssinus "INJECTION, SOLUTION" SUBCUTANEOUS 19900814
BLA BLA103752 "ALK-Abello, Inc." DERMATOPHAGOIDES PTERONYSSINUS
10000 [AU]/mL "Standardized Insect Allergenic Extract [EPC],Increased Histamin
e Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigen
s, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],
Allergens [Chemical/Ingredient]"
ronyssinus "INJECTION, SOLUTION" SUBCUTANEOUS 19900814
BLA BLA103752 "ALK-Abello, Inc." DERMATOPHAGOIDES PTERONYSSINUS
0268-0279_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-0279 HUMAN PRESCRIPTI
ON DRUG "Timothy, Standardized" "Timothy, Standardized" "INJECTION, SOLU
TION" SUBCUTANEOUS 19971218 BLA BLA103058 "ALK-Abe
llo, Inc." PHLEUM PRATENSE POLLEN 100000 [BAU]/mL "Standardized Po
llen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Imm
unity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens
ON DRUG "Timothy, Standardized" "Timothy, Standardized" "INJECTION, SOLU
llo, Inc." PHLEUM PRATENSE POLLEN 10000 [BAU]/mL "Standardized Po
ON DRUG "Orchard Grass, Standardized" "Orchard Grass, Standardized"
4 "ALK-Abello, Inc." ALLERGENIC EXTRACT- ORCHARD GRASS DACTYLIS GLOME
RATA 100000 [BAU]/mL "Standardized Pollen Allergenic Extract [EPC],In
creased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Product
ion [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
4 "ALK-Abello, Inc." ALLERGENIC EXTRACT- ORCHARD GRASS DACTYLIS GLOME
RATA 10000 [BAU]/mL "Standardized Pollen Allergenic Extract [EPC],In
ON DRUG "Kentucky Bluegrass (June), Standardized" "Kentucky Bluegr
ass (June), Standardized" "INJECTION, SOLUTION" SUBCUTANEOUS 19971218
[BAU]/mL "Standardized Pollen Allergenic Extract [EPC],Increased Histamin
ass (June), Standardized" "INJECTION, SOLUTION" SUBCUTANEOUS 19971218
ON DRUG "Redtop Grass, Standardized" "Redtop Grass, Standardized"
5 "ALK-Abello, Inc." AGROSTIS GIGANTEA POLLEN 100000 [BAU]/mL
"Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic
Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Incr
eased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingre
dient]"
5 "ALK-Abello, Inc." AGROSTIS GIGANTEA POLLEN 10000 [BAU]/mL
dient]"
ON DRUG "Sweet Vernal Grass, Standardized" "Sweet Vernal Grass, Sta
ndardized" "INJECTION, SOLUTION" SUBCUTANEOUS 19971218
BLA BLA103057 "ALK-Abello, Inc." ANTHOXANTHUM ODORATUM POLLEN
100000 [BAU]/mL "Standardized Pollen Allergenic Extract [EPC],Increased
ndardized" "INJECTION, SOLUTION" SUBCUTANEOUS 19971218
BLA BLA103057 "ALK-Abello, Inc." ANTHOXANTHUM ODORATUM POLLEN
ON DRUG "Rye Grass, Perennial Standardized" "Rye Grass, Perennial St
andardized" "INJECTION, SOLUTION" SUBCUTANEOUS 19971218
BLA BLA103056 "ALK-Abello, Inc." "ALLERGENIC EXTRACT- RYEGRASS, P
ERENNIAL LOLIUM PERENNE" 100000 [BAU]/mL "Standardized Pollen All
E],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemica
l/Ingredient]"
BLA BLA103056 "ALK-Abello, Inc." "ALLERGENIC EXTRACT- RYEGRASS, P
ERENNIAL LOLIUM PERENNE" 10000 [BAU]/mL "Standardized Pollen All
l/Ingredient]"
ON DRUG "Meadow Fescue Grass, Standardized" "Meadow Fescue Grass, St
ON DRUG "Bermuda Grass, Standardized" "Bermuda Grass, Standardized"
1 "ALK-Abello, Inc." CYNODON DACTYLON POLLEN 10000 [BAU]/mL
"Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],C
ell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingred
ient],Allergens [Chemical/Ingredient]"
ALLERGENIC BOS TAURUS SKIN CATTLE EPITHELIA "INJECTION, SOLU
llo, Inc." BOS TAURUS SKIN 0.05 g/mL "Non-Standardized Animal Skin Al
lergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [
PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allerge
ns [Chemical/Ingredient]"
llo, Inc." BOS TAURUS SKIN 10000 [PNU]/mL "Non-Standardized Animal
Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Im
munity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient]
,Allergens [Chemical/Ingredient]"
ALLERGENIC COTTON FIBER COTTON LINTERS "INJECTION, SOLUTION"
." COTTON FIBER 0.05 g/mL "Non-Standardized Plant Fiber Allergenic
eased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemic
al/Ingredient]"
ALLERGENIC COTTON SEED COTTONSEED "INJECTION, SOLUTION"
." COTTON SEED 0.05 g/mL "Non-Standardized Plant Allergenic Extra
ct [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased
IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ing
redient],Seed Storage Proteins [Chemical/Ingredient]"
ALLERGENIC CANIS LUPUS FAMILIARIS SKIN DOG EPITHELIA "INJECTI
ON, SOLUTION" SUBCUTANEOUS 19650101 BLA BLA103753
"ALK-Abello, Inc." CANIS LUPUS FAMILIARIS SKIN 0.1 g/mL "Non-Sta
ndardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],
Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chem
ical/Ingredient],Allergens [Chemical/Ingredient]"
"ALK-Abello, Inc." CANIS LUPUS FAMILIARIS SKIN 1000 [PNU]/mL
"Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Relea
se [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epiderm
al [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
"ALK-Abello, Inc." CANIS LUPUS FAMILIARIS SKIN 0.05 [PNU]/mL
ALLERGENIC EQUUS CABALLUS SKIN HORSE EPITHELIA "INJECTION, SOLU
llo, Inc." EQUUS CABALLUS SKIN 0.1 g/mL "Non-Standardized Animal
llo, Inc." EQUUS CABALLUS SKIN 10000 [PNU]/mL "Non-Standardize
d Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-med
iated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ing
redient],Allergens [Chemical/Ingredient]"
ALLERGENIC CEIBA PENTANDRA FIBER KAPOK "INJECTION, SOLUTION"
." CEIBA PENTANDRA FIBER 0.05 g/mL "Non-Standardized Plant Fiber Al
PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens
ALLERGENIC MUS MUSCULUS SKIN MOUSE EPITHELIA "INJECTION, SOLU
llo, Inc." MUS MUSCULUS SKIN 0.05 g/mL "Non-Standardized Animal
ALLERGENIC MUS MUSCULUS SKIN MOUSE EPITHELIA "INJECTION, SOLU
llo, Inc." MUS MUSCULUS SKIN 100 [PNU]/mL "Non-Standardize
ALLERGENIC ORRIS ORRIS "INJECTION, SOLUTION" SUBCUTANEOUS
19650101 BLA BLA103753 "ALK-Abello, Inc." ORRIS
0.05 g/mL
ALLERGENIC PYRETHRUM CINERARIIFOLIUM PYRETHRUM CINERARIIFOLIU
M "INJECTION, SOLUTION" SUBCUTANEOUS 19650101 BLA
BLA103753 "ALK-Abello, Inc." PYRETHRUM CINERARIIFOLIUM 0.1
g/mL "Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Rel
ease [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [C
hemical/Ingredient],Plant Proteins [Chemical/Ingredient]"
ALLERGENIC PYRETHRUM CINERARIIFOLIUM PYRETHRUM CINERARIIFOLIU
M "INJECTION, SOLUTION" SUBCUTANEOUS 19650101 BLA
BLA103753 "ALK-Abello, Inc." PYRETHRUM CINERARIIFOLIUM 0.05
g/mL "Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Rel
ease [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [C
ALLERGENIC RABBIT RABBIT "INJECTION, SOLUTION" SUBCUTANEOUS
19650101 BLA BLA103753 "ALK-Abello, Inc." RABBIT
10000 [PNU]/mL "Non-Standardized Food Allergenic Extract [EPC],Increase
d Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredi
ent],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient]"
0.1 g/mL "Non-Standardized Food Allergenic Extract [EPC],Increased Histam
ine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Die
tary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient]"
20000 [PNU]/mL "Non-Standardized Food Allergenic Extract [EPC],Increase
ent],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient]"
ALLERGENIC CAVIA PORCELLUS SKIN GUINEA PIG EPITHELIA "INJECTI
"ALK-Abello, Inc." CAVIA PORCELLUS SKIN 0.05 g/mL "Non-Standardize
"ALK-Abello, Inc." CAVIA PORCELLUS SKIN 10000 [PNU]/mL "Non-Sta
ALLERGENIC PERIPLANETA AMERICANA AMERICAN COCKROACH "INJECTI
"ALK-Abello, Inc." PERIPLANETA AMERICANA 10000 [PNU]/mL "Non-Sta
ndardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-
mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/I
ngredient],Allergens [Chemical/Ingredient]"
"ALK-Abello, Inc." PERIPLANETA AMERICANA 0.05 g/mL "Non-Standardize
d Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated
Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredien
t],Allergens [Chemical/Ingredient]"
ALLERGENIC BLATELLA GERMANICA GERMAN COCKROACH "INJECTI
"ALK-Abello, Inc." BLATELLA GERMANICA 0.05 g/mL "Non-Standardize
"ALK-Abello, Inc." BLATELLA GERMANICA 1000 [PNU]/mL "Non-Sta
ALLERGENIC ACREMONIUM STRICTUM ACREMONIUM STRICTUM "INJECTI
"ALK-Abello, Inc." ACREMONIUM STRICTUM 20000 [PNU]/mL "Non-Sta
ndardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-
mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/I
ALLERGENIC ALTERNARIA TENUIS ALTERNARIA TENUIS "INJECTI
"ALK-Abello, Inc." ALTERNARIA ALTERNATA 1000 [PNU]/mL "Non-Sta
"ALK-Abello, Inc." ALTERNARIA ALTERNATA 0.01 g/mL "Non-Standardize
d Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated
Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredien
ALLERGENIC ASPERGILLUS FUMIGATUS ASPERGILLUS FUMIGATUS "INJECTI
"ALK-Abello, Inc." ASPERGILLUS FUMIGATUS 20000 [PNU]/mL "Non-Sta
mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical
/Ingredient]"
/Ingredient]"
/Ingredient]"
/Ingredient]"
/Ingredient]"
/Ingredient]"
"ALK-Abello, Inc." ASPERGILLUS FUMIGATUS 0.02 g/mL "Non-Standardize
Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredi
ent]"
ent]"
/Ingredient]"
/Ingredient]"
ALLERGENIC ASPERGILLUS NIGER VAR NIGER ASPERGILLUS NIGER
3 "ALK-Abello, Inc." ASPERGILLUS NIGER VAR. NIGER 20000 [PNU]/mL
"Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [P
E],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Ch
emical/Ingredient],Allergens [Chemical/Ingredient]"
ALLERGENIC AUREOBASIDIUM PULLULANS VAR PULLULANS PULLULARIA PULLU
LANS "INJECTION, SOLUTION" SUBCUTANEOUS 19650101 BLA
BLA103753 "ALK-Abello, Inc." AUREOBASIDIUM PULLULANS VAR. PULLUTANS
20000 [PNU]/mL "Non-Standardized Fungal Allergenic Extract [EPC],Increa
[PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
ALLERGENIC BOTRYTIS CINEREA BOTRYTIS CINEREA "INJECTI
"ALK-Abello, Inc." BOTRYTIS CINEREA 20000 [PNU]/mL "Non-Sta
ALLERGENIC CANDIDA ALBICANS CANDIDA ALBICANS "INJECTI
"ALK-Abello, Inc." CANDIDA ALBICANS 0.01 g/mL "Cell-mediated I
mmunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient]
,Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC
],Increased Histamine Release [PE]"
"ALK-Abello, Inc." CANDIDA ALBICANS 20000 [PNU]/mL "Cell-me
diated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ing
redient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extr
act [EPC],Increased Histamine Release [PE]"
ALLERGENIC CHAETOMIUM GLOBOSUM CHAETOMIUM GLOBOSUM "INJECTI
"ALK-Abello, Inc." CHAETOMIUM GLOBOSUM 20000 [PNU]/mL "Non-Sta
ALLERGENIC CLADOSPORIUM CLADOSPORIOIDES CLADOSPORIUM CLADOSPORIO
IDES "INJECTION, SOLUTION" SUBCUTANEOUS 19650101 BLA
BLA103753 "ALK-Abello, Inc." CLADOSPORIUM CLADOSPORIOIDES 20000
[PNU]/mL "Non-Standardized Fungal Allergenic Extract [EPC],Increased Hist
amine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fun
gal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
BLA103753 "ALK-Abello, Inc." CLADOSPORIUM CLADOSPORIOIDES 0.01
g/mL "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Re
lease [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Prot
eins [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
BLA103753 "ALK-Abello, Inc." CLADOSPORIUM CLADOSPORIOIDES 0.001
ALLERGENIC CLADOSPORIUM SPHAEROSPERMUM CLADOSPORIUM SPHAEROSPER
MUM "INJECTION, SOLUTION" SUBCUTANEOUS 19650101 BLA
BLA103753 "ALK-Abello, Inc." CLADOSPORIUM SPHAEROSPERMUM 10000
BLA103753 "ALK-Abello, Inc." CLADOSPORIUM SPHAEROSPERMUM 0.001
ALLERGENIC COCHLIOBOLUS SATIVUS HELMINTHOSPORIUM SOROKINIANUM
3 "ALK-Abello, Inc." COCHLIOBOLUS SATIVUS 20000 [PNU]/mL
3 "ALK-Abello, Inc." COCHLIOBOLUS SATIVUS 0.001 g/mL "Non-Sta
ALLERGENIC EPICOCCUM NIGRUM EPICOCCUM NIGRUM "INJECTI
"ALK-Abello, Inc." EPICOCCUM NIGRUM 20000 [PNU]/mL "Increas
ed IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical
/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamin
e Release [PE],Cell-mediated Immunity [PE]"
"ALK-Abello, Inc." EPICOCCUM NIGRUM 0.025 g/mL "Increased IgG P
roduction [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredi
ent],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Releas
e [PE],Cell-mediated Immunity [PE]"
ALLERGENIC FUSARIUM OXYSPORUM VASINFECTUM FUSARIUM VASINFECTUM
3 "ALK-Abello, Inc." FUSARIUM OXYSPORUM VASINFECTUM 20000 [PNU]/mL
3 "ALK-Abello, Inc." FUSARIUM OXYSPORUM VASINFECTUM 0.001 g/mL
ALLERGENIC HELMINTHOSPORIUM SOLANI HELMINTHOSPORIUM SOLANI "INJECTI
"ALK-Abello, Inc." HELMINTHOSPORIUM SOLANI 40000 [PNU]/mL "Non-Sta
ALLERGENIC MUCOR PLUMBEUS MUCOR PLUMBEUS "INJECTION, SOLUTION"
." MUCOR PLUMBEUS 20000 [PNU]/mL "Non-Standardized Fungal Allerge
nic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],I
ncreased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Ch
emical/Ingredient]"
emical/Ingredient]"
emical/Ingredient]"
emical/Ingredient]"
emical/Ingredient]"
ALLERGENIC NEUROSPORA INTERMEDIA NEUROSPORA INTERMEDIA "INJECTI
"ALK-Abello, Inc." NEUROSPORA INTERMEDIA 40000 [PNU]/mL "Non-Sta
"ALK-Abello, Inc." NEUROSPORA INTERMEDIA 0.001 g/mL "Non-Standardize
ALLERGENIC PENICILLIUM CHRYSOGENUM VAR CHRYSOGENUM PENICILLIUM CHRY
SOGENUM "INJECTION, SOLUTION" SUBCUTANEOUS 19650101 BLA
BLA103753 "ALK-Abello, Inc." PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM
0.001 g/mL "Non-Standardized Fungal Allergenic Extract [EPC],Increased Hist
ALLERGENIC PHOMA EXIGUA VAR EXIGUA PHOMA HERBARUM "INJECTION, SOLU
llo, Inc." PHOMA EXIGUA VAR. EXIGUA 20000 [PNU]/mL "Non-Sta
llo, Inc." PHOMA EXIGUA VAR. EXIGUA 0.001 g/mL "Non-Standardize
ALLERGENIC RHIZOPUS ARRHIZUS VAR ARRHIZUS RHIZOPUS BATATAS
3 "ALK-Abello, Inc." RHIZOPUS ARRHIZUS VAR. ARRHIZUS 20000 [PNU]/mL
ALLERGENIC RHODOTORULA RUBRA RHODOTORULA RUBRA "INJECTI
"ALK-Abello, Inc." RHODOTORULA RUBRA 40000 [PNU]/mL "Non-Sta
ALLERGENIC USTILAGO MAYDIS CORN SMUT "INJECTION, SOLUTION"
." USTILAGO MAYDIS 0.05 g/mL "Non-Standardized Fungal Allergenic Extr
IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/I
ngredient]"
ALLERGENIC USTILAGO MAYDIS CORN SMUT "INJECTION, SOLUTION"
ngredient]"
ALLERGENIC USTILAGO TRITICI LOOSE WHEAT SMUT "INJECTI
"ALK-Abello, Inc." USTILAGO TRITICI 0.05 g/mL "Non-Standardize
ALLERGENIC STEMPHYLIUM SOLANI STEMPHYLIUM SOLANI "INJECTI
"ALK-Abello, Inc." STEMPHYLIUM SOLANI 20000 [PNU]/mL "Non-Sta
"ALK-Abello, Inc." STEMPHYLIUM SOLANI 0.001 g/mL "Non-Standardize
ALLERGENIC TRICHOPHYTON MENTAGROPHYTES TRICHOPHYTON MENTAGROPHY
TES "INJECTION, SOLUTION" SUBCUTANEOUS 19650101 BLA
BLA103753 "ALK-Abello, Inc." TRICHOPHYTON MENTAGROPHYTES 20000
BLA103753 "ALK-Abello, Inc." TRICHOPHYTON MENTAGROPHYTES 0.005
ALLERGENIC SACCHAROMYCES CEREVISIAE SACCHAROMYCES CEREVISIAE
3 "ALK-Abello, Inc." SACCHAROMYCES CEREVISIAE 20000 [PNU]/mL
E],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical
/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Aller
genic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased His
tamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingre
dient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient]"
ALLERGENIC SACCHAROMYCES CEREVISIAE SACCHAROMYCES CEREVISIAE
3 "ALK-Abello, Inc." SACCHAROMYCES CEREVISIAE 10000 [PNU]/mL
E],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical
/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Aller
genic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased His
tamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingre
dient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient]"
ALLERGENIC ACACIA Acacia "INJECTION, SOLUTION" SUBCUTANEOUS
19650101 BLA BLA103753 "ALK-Abello, Inc." ACACIA
0.1 g/mL "Non-Standardized Plant Allergenic Extract [EPC],Increased Hista
mine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plan
t Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
ALLERGENIC ACACIA Acacia "INJECTION, SOLUTION" SUBCUTANEOUS
ALLERGENIC AILANTHUS ALTISSIMA POLLEN Ailanthus Tree of Heaven
3 "ALK-Abello, Inc." AILANTHUS ALTISSIMA POLLEN 0.05 g/mL
ALLERGENIC ALNUS INCANA SSP RUGOSA POLLEN Alder White "INJECTI
"ALK-Abello, Inc." ALNUS INCANA SUBSP. RUGOSA POLLEN 0.1 g/mL
"ALK-Abello, Inc." ALNUS INCANA SUBSP. RUGOSA POLLEN 40000 [PNU]/mL
ALLERGENIC MEDICAGO SATIVA POLLEN Alfalfa "INJECTION, SOLUTION"
." MEDICAGO SATIVA POLLEN 0.05 g/mL "Non-Standardized Pollen Allerge
ncreased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/In
gredient]"
." MEDICAGO SATIVA POLLEN 1000 [PNU]/mL "Non-Standardized Pollen
Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunit
y [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Che
mical/Ingredient]"
ALLERGENIC FRAXINUS VELUTINA POLLEN Ash Arizona "INJECTI
"ALK-Abello, Inc." FRAXINUS VELUTINA POLLEN 0.1 g/mL "Non-Sta
ndardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-
mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient
],Allergens [Chemical/Ingredient]"
"ALK-Abello, Inc." FRAXINUS VELUTINA POLLEN 0.05 g/mL "Non-Sta
"ALK-Abello, Inc." FRAXINUS VELUTINA POLLEN 10000 [PNU]/mL
ALLERGENIC FRAXINUS AMERICANA POLLEN Ash White "INJECTI
"ALK-Abello, Inc." FRAXINUS AMERICANA POLLEN 0.001 g/mL "Non-Sta
"ALK-Abello, Inc." FRAXINUS AMERICANA POLLEN 40000 [PNU]/mL
ALLERGENIC POPULUS TREMULOIDES POLLEN Aspen "INJECTION, SOLU
llo, Inc." POPULUS TREMULOIDES POLLEN 0.1 g/mL "Non-Standardize
d Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated
Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allerg
ens [Chemical/Ingredient]"
ALLERGENIC PASPALUM NOTATUM POLLEN Bahia Grass "INJECTION, SOLU
llo, Inc." PASPALUM NOTATUM POLLEN 0.001 g/mL "Non-Standardized Pollen
mical/Ingredient]"
mical/Ingredient]"
mical/Ingredient]"
llo, Inc." PASPALUM NOTATUM POLLEN 40000 [PNU]/mL "Non-Standardize
ALLERGENIC MORELLA CERIFERA POLLEN Bayberry Wax Myrtle "INJECTI
"ALK-Abello, Inc." MORELLA CERIFERA POLLEN 0.1 g/mL "Non-Standardize
"ALK-Abello, Inc." MORELLA CERIFERA POLLEN 20000 [PNU]/mL "Non-Sta
ALLERGENIC FAGUS GRANDIFOLIA POLLEN Beech "INJECTION, SOLU
llo, Inc." FAGUS GRANDIFOLIA POLLEN 0.1 g/mL "Non-Standardize
llo, Inc." FAGUS GRANDIFOLIA POLLEN 40000 [PNU]/mL "Non-Sta
ALLERGENIC BETULA LENTA POLLEN Birch Black "INJECTION, SOLU
llo, Inc." BETULA LENTA POLLEN 0.1 g/mL "Non-Standardized Pollen
mical/Ingredient]"
llo, Inc." BETULA LENTA POLLEN 40000 [PNU]/mL "Non-Standardize
mical/Ingredient]"
ALLERGENIC BETULA NIGRA POLLEN Birch River Red "INJECTION, SOLU
llo, Inc." BETULA NIGRA POLLEN 0.1 g/mL "Non-Standardized Pollen
mical/Ingredient]"
mical/Ingredient]"
llo, Inc." BETULA NIGRA POLLEN 10000 [PNU]/mL "Non-Standardize
ALLERGENIC BETULA LENTA POLLEN Birch White "INJECTION, SOLU
mical/Ingredient]"
mical/Ingredient]"
mical/Ingredient]"
mical/Ingredient]"
ALLERGENIC POA ANNUA POLLEN Bluegrass Annual "INJECTI
"ALK-Abello, Inc." POA ANNUA POLLEN 0.1 g/mL "Non-Standardize
ALLERGENIC POA ANNUA POLLEN Bluegrass Annual "INJECTI
ALLERGENIC ACER NEGUNDO POLLEN Box Elder Ash Leaf Maple
3 "ALK-Abello, Inc." ACER NEGUNDO POLLEN 0.1 g/mL "Non-Sta
3 "ALK-Abello, Inc." ACER NEGUNDO POLLEN 40000 [PNU]/mL
ALLERGENIC BROMUS INERMIS POLLEN Brome Grass "INJECTION, SOLU
llo, Inc." BROMUS INERMIS POLLEN 0.1 g/mL "Non-Standardized Pollen
mical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased His
tamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Po
llen [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
ON DRUG CENTER-AL - BROMUS INERMIS POLLEN Allergenic Extracts Alum
BLA BLA103753 "ALK-Abello, Inc." BROMUS INERMIS POLLEN 10000
emical/Ingredient]"
llo, Inc." BROMUS INERMIS POLLEN 40000 [PNU]/mL "Non-Standardize
ens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Incre
ased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production
ALLERGENIC AMARANTHUS PALMERI POLLEN Carelessweed "INJECTI
"ALK-Abello, Inc." AMARANTHUS PALMERI POLLEN 0.05 g/mL "Non-Sta
mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredie
nt]"
nt]"
"ALK-Abello, Inc." AMARANTHUS PALMERI POLLEN 20000 [PNU]/mL
E],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/
Ingredient]"
ALLERGENIC JUNIPERUS ASHEI POLLEN Cedar Mountain "INJECTION, SOLU
llo, Inc." JUNIPERUS ASHEI POLLEN 0.1 g/mL "Non-Standardized Pollen
mical/Ingredient]"
mical/Ingredient]"
llo, Inc." JUNIPERUS ASHEI POLLEN 10000 [PNU]/mL "Non-Standardize
ALLERGENIC JUNIPERUS VIRGINIANA POLLEN Cedar Red "INJECTI
"ALK-Abello, Inc." JUNIPERUS VIRGINIANA POLLEN 0.1 g/mL "Non-Sta
"ALK-Abello, Inc." JUNIPERUS VIRGINIANA POLLEN 10000 [PNU]/mL
ALLERGENIC XANTHIUM STRUMARIUM VAR CANADENSE POLLEN Cocklebu
r "INJECTION, SOLUTION" SUBCUTANEOUS 19650101 BLA
BLA103753 "ALK-Abello, Inc." XANTHIUM STRUMARIUM VAR. CANADENSE POLLE
N 0.1 g/mL "Non-Standardized Pollen Allergenic Extract [EPC],Increa
N 40000 [PNU]/mL "Non-Standardized Pollen Allergenic Extract [EPC
],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Pro
duction [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
ALLERGENIC ZEA MAYS POLLEN Corn Pollen "INJECTION, SOLUTION"
." ZEA MAYS POLLEN 0.1 g/mL "Non-Standardized Pollen Allergenic Extr
]"
]"
." ZEA MAYS POLLEN 40000 [PNU]/mL "Non-Standardized Pollen Allerge
gredient]"
." ZEA MAYS POLLEN 500 [PNU]/mL "Non-Standardized Pollen Allerge
gredient]"
ALLERGENIC POPULUS DELTOIDES POLLEN Cottonwood Eastern Commo
n "INJECTION, SOLUTION" SUBCUTANEOUS 19650101 BLA
BLA103753 "ALK-Abello, Inc." POPULUS DELTOIDES POLLEN 0.1
g/mL "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Re
lease [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Che
mical/Ingredient],Allergens [Chemical/Ingredient]"
BLA103753 "ALK-Abello, Inc." POPULUS DELTOIDES POLLEN 20000
ALLERGENIC POPULUS FREMONTII POLLEN Cottonwood Fremont
3 "ALK-Abello, Inc." POPULUS FREMONTII POLLEN 0.1 g/mL
3 "ALK-Abello, Inc." POPULUS FREMONTII POLLEN 40000 [PNU]/mL
ALLERGENIC POPULUS DELTOIDES SSP MONILIFERA POLLEN Cottonwood Weste
rn "INJECTION, SOLUTION" SUBCUTANEOUS 19650101 BLA
BLA103753 "ALK-Abello, Inc." POPULUS DELTOIDES SUBSP. MONILIFERA POLL
EN 0.1 g/mL "Non-Standardized Pollen Allergenic Extract [EPC],Increa
ALLERGENIC POPULUS DELTOIDES SSP MONILIFERA POLLEN Cottonwood Weste
rn "INJECTION, SOLUTION" SUBCUTANEOUS 19650101 BLA
ALLERGENIC CUPRESSUS ARIZONICA POLLEN Cypress Arizona "INJECTI
"ALK-Abello, Inc." CUPRESSUS ARIZONICA POLLEN 0.1 g/mL "Non-Sta
ALLERGENIC CUPRESSUS ARIZONICA POLLEN Cypress Arizona "INJECTI
ALLERGENIC TAXODIUM DISTICHUM POLLEN Cypress Bald "INJECTI
"ALK-Abello, Inc." TAXODIUM DISTICHUM POLLEN 0.1 g/mL "Non-Sta
ALLERGENIC RUMEX ACETOSELLA POLLEN Dock Sour Sheep Sorrel "INJECTI
"ALK-Abello, Inc." RUMEX ACETOSELLA POLLEN 0.1 g/mL "Non-Standardize
d Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Prod
uction [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allerg
"ALK-Abello, Inc." RUMEX ACETOSELLA POLLEN 40000 [PNU]/mL "Non-Sta
ndardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased
IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE
ALLERGENIC RUMEX CRISPUS POLLEN Dock Yellow "INJECTION, SOLU
llo, Inc." RUMEX CRISPUS POLLEN 0.1 g/mL "Non-Standardized Pollen
mical/Ingredient]"
mical/Ingredient]"
llo, Inc." RUMEX CRISPUS POLLEN 40000 [PNU]/mL "Non-Standardize
ALLERGENIC EUPATORIUM CAPILLIFOLIUM POLLEN Dog Fennel "INJECTI
"ALK-Abello, Inc." EUPATORIUM CAPILLIFOLIUM POLLEN 0.1 g/mL "Non-Sta
ALLERGENIC EUPATORIUM CAPILLIFOLIUM POLLEN Dog Fennel Non Stock
3 "ALK-Abello, Inc." EUPATORIUM CAPILLIFOLIUM POLLEN 0.05 g/mL
ALLERGENIC ULMUS AMERICANA POLLEN Elm American "INJECTION, SOLU
llo, Inc." ULMUS AMERICANA POLLEN 0.1 g/mL "Non-Standardized Pollen
mical/Ingredient]"
mical/Ingredient]"
llo, Inc." ULMUS AMERICANA POLLEN 40000 [PNU]/mL "Non-Standardize
mical/Ingredient]"
mical/Ingredient]"
mical/Ingredient]"
ALLERGENIC ULMUS CRASSIFOLIA POLLEN Elm Cedar "INJECTI
"ALK-Abello, Inc." ULMUS CRASSIFOLIA POLLEN 0.1 g/mL "Non-Sta
ALLERGENIC ULMUS CRASSIFOLIA POLLEN Elm Cedar "INJECTI
ALLERGENIC ULMUS PUMILA POLLEN Elm Chinese "INJECTION, SOLU
llo, Inc." ULMUS PUMILA POLLEN 0.1 g/mL "Non-Standardized Pollen
mical/Ingredient]"
ALLERGENIC ULMUS PUMILA POLLEN Elm Chinese "INJECTION, SOLU
mical/Ingredient]"
ALLERGENIC EUCALYPTUS GLOBULUS POLLEN Eucalyptus "INJECTI
"ALK-Abello, Inc." EUCALYPTUS GLOBULUS POLLEN 0.1 g/mL "Non-Sta
"ALK-Abello, Inc." EUCALYPTUS GLOBULUS POLLEN 10000 [PNU]/mL
ALLERGENIC SOLIDAGO CANADENSIS POLLEN Goldenrod "INJECTI
"ALK-Abello, Inc." SOLIDAGO CANADENSIS POLLEN 0.1 g/mL "Non-Sta
"ALK-Abello, Inc." SOLIDAGO CANADENSIS POLLEN 10000 [PNU]/mL
ALLERGENIC CELTIS OCCIDENTALIS POLLEN Hackberry "INJECTI
"ALK-Abello, Inc." CELTIS OCCIDENTALIS POLLEN 0.1 g/mL "Non-Sta
ALLERGENIC CORYLUS AMERICANA POLLEN Hazelnut Pollen "INJECTI
"ALK-Abello, Inc." CORYLUS AMERICANA POLLEN 0.1 g/mL "Non-Sta
"ALK-Abello, Inc." CORYLUS AMERICANA POLLEN 20000 [PNU]/mL
ALLERGENIC SORGHUM HALEPENSE POLLEN Johnson Grass "INJECTI
"ALK-Abello, Inc." SORGHUM HALEPENSE POLLEN 0.1 g/mL "Non-Sta
"ALK-Abello, Inc." SORGHUM HALEPENSE POLLEN 40000 [PNU]/mL
ALLERGENIC JUNIPERUS CALIFORNICA POLLEN Juniper Western "INJECTI
"ALK-Abello, Inc." JUNIPERUS CALIFORNICA POLLEN 0.1 g/mL "Non-Sta
"ALK-Abello, Inc." JUNIPERUS CALIFORNICA POLLEN 10000 [PNU]/mL
ALLERGENIC KOCHIA SCOPARIA POLLEN Kochia Firebush "INJECTION, SOLU
llo, Inc." KOCHIA SCOPARIA POLLEN 0.1 g/mL "Non-Standardized Pollen
mical/Ingredient]"
mical/Ingredient]"
llo, Inc." KOCHIA SCOPARIA POLLEN 40000 [PNU]/mL "Non-Standardize
ALLERGENIC CHENOPODIUM ALBUM POLLEN Lambs Quarters "INJECTI
"ALK-Abello, Inc." CHENOPODIUM ALBUM POLLEN 0.1 g/mL "Non-Sta
"ALK-Abello, Inc." CHENOPODIUM ALBUM POLLEN 40000 [PNU]/mL
ALLERGENIC ROBINIA PSEUDOACACIA POLLEN Locust Black Non Stock
3 "ALK-Abello, Inc." ROBINIA PSEUDOACACIA POLLEN 0.05 g/mL
ALLERGENIC ACER RUBRUM POLLEN Maple Red "INJECTION, SOLU
llo, Inc." ACER RUBRUM POLLEN 0.1 g/mL "Non-Standardized Pollen
mical/Ingredient]"
ALLERGENIC ACER RUBRUM POLLEN Maple Red "INJECTION, SOLU
mical/Ingredient]"
ALLERGENIC ACER SACCHARUM POLLEN Maple Sugar "INJECTION, SOLU
llo, Inc." ACER SACCHARUM POLLEN 0.1 g/mL "Non-Standardized Pollen
mical/Ingredient]"
llo, Inc." ACER SACCHARUM POLLEN 40000 [PNU]/mL "Non-Standardize
mical/Ingredient]"
ALLERGENIC IVA XANTHIFOLIA POLLEN Marshelder Burweed "INJECTI
"ALK-Abello, Inc." IVA XANTHIFOLIA POLLEN 0.1 g/mL "Non-Standardize
"ALK-Abello, Inc." IVA XANTHIFOLIA POLLEN 40000 [PNU]/mL "Non-Sta
ALLERGENIC IVA ANNUA VAR ANNUA POLLEN Marshelder Rough
3 "ALK-Abello, Inc." IVA ANNUA VAR. ANNUA POLLEN 0.1 g/mL
3 "ALK-Abello, Inc." IVA ANNUA VAR. ANNUA POLLEN 40000 [PNU]/mL
ALLERGENIC MELALEUCA QUINQUENERVIA POLLEN Melaleuca Pollen
3 "ALK-Abello, Inc." MELALEUCA QUINQUENERVIA POLLEN 0.1 g/mL
3 "ALK-Abello, Inc." MELALEUCA QUINQUENERVIA POLLEN 10000 [PNU]/mL
3 "ALK-Abello, Inc." MELALEUCA QUINQUENERVIA POLLEN 40000 [PNU]/mL
ALLERGENIC PROSOPIS JULIFLORA POLLEN Mesquite "INJECTI
"ALK-Abello, Inc." PROSOPIS JULIFLORA POLLEN 0.1 g/mL "Non-Sta
"ALK-Abello, Inc." PROSOPIS JULIFLORA POLLEN 40000 [PNU]/mL
ALLERGENIC CHENOPODIUM AMBROSIOIDES POLLEN Mexican Tea "INJECTI
"ALK-Abello, Inc." CHENOPODIUM AMBROSIOIDES POLLEN 0.1 g/mL "Non-Sta
ALLERGENIC ARTEMISIA VULGARIS POLLEN Mugwort Common "INJECTI
"ALK-Abello, Inc." ARTEMISIA VULGARIS POLLEN 0.1 g/mL "Non-Sta
nt]"
nt]"
"ALK-Abello, Inc." ARTEMISIA VULGARIS POLLEN 40000 [PNU]/mL
Ingredient]"
Ingredient]"
Ingredient]"
ALLERGENIC MORUS RUBRA POLLEN Mulberry Red "INJECTION, SOLU
llo, Inc." MORUS RUBRA POLLEN 0.1 g/mL "Non-Standardized Pollen
mical/Ingredient]"
mical/Ingredient]"
llo, Inc." MORUS RUBRA POLLEN 40000 [PNU]/mL "Non-Standardize
mical/Ingredient]"
ALLERGENIC MORUS ALBA POLLEN Mulberry White "INJECTION, SOLU
llo, Inc." MORUS ALBA POLLEN 0.1 g/mL "Non-Standardized Pollen
mical/Ingredient]"
ALLERGENIC MORUS ALBA POLLEN Mulberry White "INJECTION, SOLU
mical/Ingredient]"
ALLERGENIC QUERCUS AGRIFOLIA POLLEN Oak California Live Coas
t "INJECTION, SOLUTION" SUBCUTANEOUS 19650101 BLA
BLA103753 "ALK-Abello, Inc." QUERCUS AGRIFOLIA POLLEN 0.1
ALLERGENIC QUERCUS RUBRA POLLEN Oak Red "INJECTION, SOLUTION"
." QUERCUS RUBRA POLLEN 0.1 g/mL "Non-Standardized Pollen Allerge
gredient]"
ALLERGENIC QUERCUS RUBRA POLLEN Oak Red "INJECTION, SOLUTION"
gredient]"
ALLERGENIC QUERCUS VIRGINIANA POLLEN Oak Virginia Live
3 "ALK-Abello, Inc." QUERCUS VIRGINIANA POLLEN 0.1 g/mL
3 "ALK-Abello, Inc." QUERCUS VIRGINIANA POLLEN 40000 [PNU]/mL
ALLERGENIC QUERCUS ALBA POLLEN Oak White "INJECTION, SOLU
llo, Inc." QUERCUS ALBA POLLEN 0.1 g/mL "Non-Standardized Pollen
mical/Ingredient]"
mical/Ingredient]"
llo, Inc." QUERCUS ALBA POLLEN 40000 [PNU]/mL "Non-Standardize
mical/Ingredient]"
ALLERGENIC QUERCUS ALBA POLLEN Oat Wild Pollen "INJECTION, SOLU
mical/Ingredient]"
ALLERGENIC OLEA EUROPAEA POLLEN Olive Pollen "INJECTION, SOLU
llo, Inc." OLEA EUROPAEA POLLEN 0.1 g/mL "Non-Standardized Pollen
mical/Ingredient]"
mical/Ingredient]"
ALLERGENIC SYAGRUS ROMANZOFFIANA POLLEN Palm Queen Coco Palm
3 "ALK-Abello, Inc." SYAGRUS ROMANZOFFIANA POLLEN 0.1 g/mL
ALLERGENIC SYAGRUS ROMANZOFFIANA POLLEN Palm Queen Coco Palm
ALLERGENIC CARYA ILLINOINENSIS POLLEN Pecan Pollen "INJECTI
"ALK-Abello, Inc." CARYA ILLINOINENSIS POLLEN 0.1 g/mL "Non-Sta
"ALK-Abello, Inc." CARYA ILLINOINENSIS POLLEN 20000 [PNU]/mL
ALLERGENIC SCHINUS MOLLE POLLEN Pepper Tree California "INJECTI
"ALK-Abello, Inc." SCHINUS MOLLE POLLEN 0.05 g/mL "Non-Standardize
ALLERGENIC AMARANTHUS RETROFLEXUS POLLEN Pigweed Rough Redroot
3 "ALK-Abello, Inc." AMARANTHUS RETROFLEXUS POLLEN 0.1 g/mL
Ingredient]"
Ingredient]"
3 "ALK-Abello, Inc." AMARANTHUS RETROFLEXUS POLLEN 40000 [PNU]/mL
Ingredient]"
Ingredient]"
Ingredient]"
ALLERGENIC AMARANTHUS SPINOSUS POLLEN Pigweed Spiny "INJECTI
"ALK-Abello, Inc." AMARANTHUS SPINOSUS POLLEN 0.1 g/mL "Non-Sta
nt]"
nt]"
"ALK-Abello, Inc." AMARANTHUS SPINOSUS POLLEN 40000 [PNU]/mL
Ingredient]"
ALLERGENIC CASUARINA EQUISETIFOLIA POLLEN Pine Australian Beefwood
3 "ALK-Abello, Inc." CASUARINA EQUISETIFOLIA POLLEN 0.1 g/mL
3 "ALK-Abello, Inc." CASUARINA EQUISETIFOLIA POLLEN 40000 [PNU]/mL
ALLERGENIC PINUS STROBUS POLLEN Pine White "INJECTION, SOLU
llo, Inc." PINUS STROBUS POLLEN 0.1 g/mL "Non-Standardized Pollen
mical/Ingredient]"
mical/Ingredient]"
llo, Inc." PINUS STROBUS POLLEN 20000 [PNU]/mL "Non-Standardize
ALLERGENIC PINUS ECHINATA POLLEN Pine Yellow "INJECTION, SOLU
llo, Inc." PINUS ECHINATA POLLEN 0.1 g/mL "Non-Standardized Pollen
mical/Ingredient]"
ALLERGENIC PINUS ECHINATA POLLEN Pine Yellow "INJECTION, SOLU
mical/Ingredient]"
ALLERGENIC PLANTAGO LANCEOLATA POLLEN Plantain English
3 "ALK-Abello, Inc." PLANTAGO LANCEOLATA POLLEN 0.1 g/mL
3 "ALK-Abello, Inc." PLANTAGO LANCEOLATA POLLEN 1000 [PNU]/mL
ALLERGENIC POPULUS ALBA POLLEN Poplar White "INJECTION, SOLU
llo, Inc." POPULUS ALBA POLLEN 0.1 g/mL "Non-Standardized Pollen
mical/Ingredient]"
mical/Ingredient]"
llo, Inc." POPULUS ALBA POLLEN 40000 [PNU]/mL "Non-Standardize
mical/Ingredient]"
mical/Ingredient]"
ALLERGENIC LIGUSTRUM VULGARE POLLEN Privet "INJECTION, SOLU
llo, Inc." LIGUSTRUM VULGARE POLLEN 0.1 g/mL "Non-Standardize
llo, Inc." LIGUSTRUM VULGARE POLLEN 10000 [PNU]/mL "Non-Sta
ALLERGENIC ELYMUS REPENS POLLEN Quack Grass "INJECTION, SOLU
llo, Inc." ELYMUS REPENS POLLEN 0.1 g/mL "Non-Standardized Pollen
mical/Ingredient]"
mical/Ingredient]"
llo, Inc." ELYMUS REPENS POLLEN 40000 [PNU]/mL "Non-Standardize
ALLERGENIC AMBROSIA ACANTHICARPA POLLEN Ragweed False Bur
3 "ALK-Abello, Inc." AMBROSIA ACANTHICARPA POLLEN 0.1 g/mL
Ingredient]"
ALLERGENIC AMBROSIA ACANTHICARPA POLLEN Ragweed False Bur
Ingredient]"
ALLERGENIC AMBROSIA TENUIFOLIA POLLEN Ragweed Slender "INJECTI
"ALK-Abello, Inc." AMBROSIA TENUIFOLIA POLLEN 0.1 g/mL "Non-Sta
nt]"
ALLERGENIC AMBROSIA TENUIFOLIA POLLEN Ragweed Slender "INJECTI
nt]"
ALLERGENIC AMBROSIA BIDENTATA POLLEN Ragweed Southern
3 "ALK-Abello, Inc." AMBROSIA BIDENTATA POLLEN 0.1 g/mL
Ingredient]"
ALLERGENIC AMBROSIA BIDENTATA POLLEN Ragweed Southern
Ingredient]"
ALLERGENIC AMBROSIA TRIFIDA POLLEN Ragweed Tall Giant "INJECTI
"ALK-Abello, Inc." AMBROSIA TRIFIDA POLLEN 0.1 g/mL "Non-Standardize
Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
"ALK-Abello, Inc." AMBROSIA TRIFIDA POLLEN 20000 [PNU]/mL "Non-Sta
nt]"
nt]"
ALLERGENIC AMBROSIA PSILOSTACHYA POLLEN Ragweed Western "INJECTI
"ALK-Abello, Inc." AMBROSIA PSILOSTACHYA POLLEN 0.1 g/mL "Non-Sta
nt]"
ALLERGENIC AMBROSIA PSILOSTACHYA POLLEN Ragweed Western "INJECTI
nt]"
ALLERGENIC SALSOLA KALI POLLEN Russian Thistle "INJECTION, SOLU
llo, Inc." SALSOLA KALI POLLEN 0.1 g/mL "Non-Standardized Pollen
mical/Ingredient]"
mical/Ingredient]"
llo, Inc." SALSOLA KALI POLLEN 40000 [PNU]/mL "Non-Standardize
mical/Ingredient]"
ALLERGENIC LOLIUM PERENNE SSP MULTIFLORUM POLLEN Rye Grass Italia
BLA103753 "ALK-Abello, Inc." LOLIUM PERENNE SSP. MULTIFLORUM POLLEN
0.05 g/mL "Non-Standardized Pollen Allergenic Extract [EPC],Increased Hist
ALLERGENIC ARTEMISIA FRIGIDA POLLEN Sage Prairie "INJECTI
"ALK-Abello, Inc." ARTEMISIA FRIGIDA POLLEN 0.1 g/mL "Non-Sta
nt]"
ALLERGENIC ARTEMISIA FRIGIDA POLLEN Sage Prairie "INJECTI
nt]"
ALLERGENIC ARTEMISIA TRIDENTATA POLLEN Sagebrush Common
3 "ALK-Abello, Inc." ARTEMISIA TRIDENTATA POLLEN 0.1 g/mL
Ingredient]"
Ingredient]"
3 "ALK-Abello, Inc." ARTEMISIA TRIDENTATA POLLEN 40000 [PNU]/mL
Ingredient]"
ALLERGENIC DISTICHLIS SPICATA POLLEN Salt Grass "INJECTI
"ALK-Abello, Inc." DISTICHLIS SPICATA POLLEN 0.1 g/mL "Non-Sta
ALLERGENIC ATRIPLEX WRIGHTII POLLEN Saltbush Annual Atriplex
3 "ALK-Abello, Inc." ATRIPLEX WRIGHTII POLLEN 0.05 g/mL
ALLERGENIC ATRIPLEX WRIGHTII POLLEN Saltbush Annual Atriplex
3 "ALK-Abello, Inc." ATRIPLEX WRIGHTII POLLEN 0.025 g/mL
ALLERGENIC LIQUIDAMBAR STYRACIFLUA POLLEN Sweetgum "INJECTI
"ALK-Abello, Inc." LIQUIDAMBAR STYRACIFLUA POLLEN 0.1 g/mL "Non-Sta
"ALK-Abello, Inc." LIQUIDAMBAR STYRACIFLUA POLLEN 40000 [PNU]/mL
"ALK-Abello, Inc." LIQUIDAMBAR STYRACIFLUA POLLEN 500 [PNU]/mL
ALLERGENIC PLATANUS OCCIDENTALIS POLLEN Sycamore American
3 "ALK-Abello, Inc." PLATANUS OCCIDENTALIS POLLEN 0.1 g/mL
3 "ALK-Abello, Inc." PLATANUS OCCIDENTALIS POLLEN 40000 [PNU]/mL
ALLERGENIC HOLCUS LANATUS POLLEN Velvet Grass "INJECTION, SOLU
llo, Inc." HOLCUS LANATUS POLLEN 0.1 g/mL "Non-Standardized Pollen
ALLERGENIC JUGLANS NIGRA POLLEN Walnut Black Pollen "INJECTI
"ALK-Abello, Inc." JUGLANS NIGRA POLLEN 0.1 g/mL "Non-Standardize
"ALK-Abello, Inc." JUGLANS NIGRA POLLEN 40000 [PNU]/mL "Non-Sta
ALLERGENIC JUGLANS NIGRA POLLEN Walnut California Black Pollen
3 "ALK-Abello, Inc." JUGLANS NIGRA POLLEN 0.05 g/mL "Non-Sta
ALLERGENIC JUGLANS REGIA POLLEN Walnut English Pollen "INJECTI
"ALK-Abello, Inc." JUGLANS REGIA POLLEN 0.1 g/mL "Non-Standardize
ALLERGENIC JUGLANS REGIA POLLEN Walnut English Pollen "INJECTI
ALLERGENIC AMARANTHUS TUBERCULATUS POLLEN Water Hemp "INJECTI
"ALK-Abello, Inc." AMARANTHUS TUBERCULATUS POLLEN 0.05 g/mL "Non-Sta
nt],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release
[PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical
/Ingredient],Allergens [Chemical/Ingredient]"
"ALK-Abello, Inc." AMARANTHUS TUBERCULATUS POLLEN 20000 [PNU]/mL
Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine
Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [
Chemical/Ingredient],Allergens [Chemical/Ingredient]"
ALLERGENIC TRITICUM AESTIVUM POLLEN Wheat Pollen "INJECTI
"ALK-Abello, Inc." TRITICUM AESTIVUM POLLEN 0.1 g/mL "Non-Sta
],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EP
C],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Pr
oduction [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
ALLERGENIC SALIX NIGRA POLLEN Willow Black "INJECTION, SOLU
llo, Inc." SALIX NIGRA POLLEN 0.1 g/mL "Non-Standardized Pollen
mical/Ingredient]"
mical/Ingredient]"
mical/Ingredient]"
llo, Inc." SALIX NIGRA POLLEN 40000 [PNU]/mL "Non-Standardize
mical/Ingredient]"
ALLERGENIC ARTEMISIA ANNUA POLLEN Wormwood Common Annual "INJECTI
"ALK-Abello, Inc." SALIX NIGRA POLLEN 0.05 g/mL "Non-Standardize
ALLERGENIC AMBROSIA ARTEMISIIFOLIA POLLEN Ragweed Short "INJECTI
"ALK-Abello, Inc." AMBROSIA ARTEMISIIFOLIA POLLEN 0.1 g/mL "Standar
dized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-medi
ated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Al
lergens [Chemical/Ingredient]"
"ALK-Abello, Inc." AMBROSIA ARTEMISIIFOLIA POLLEN 0.05 g/mL "Standar
"ALK-Abello, Inc." AMBROSIA ARTEMISIIFOLIA POLLEN 20000 [PNU]/mL
"ALK-Abello, Inc." AMBROSIA ARTEMISIIFOLIA POLLEN 40000 [PNU]/mL
mical/Ingredient]"
Ingredient]"
0268-2000_6199232a-c457-4b50-9112-794d25418367 0268-2000 HUMAN PRESCRIPTI
ON DRUG "Cat Hair, Standardized" "Cat Hair, Standardized"
0 "ALK-Abello, Inc." FELIS CATUS HAIR 10000 [BAU]/mL
"Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [
PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/I
ngredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemi
cal/Ingredient]"
0268-2001_6199232a-c457-4b50-9112-794d25418367 0268-2001 HUMAN PRESCRIPTI
ON DRUG "Cat Hair, Standardized" "Cat Hair, Standardized"
"ALK-Abello, Inc." FELIS CATUS HAIR 10000 [BAU]/mL "Standar
dized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell
-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredien
t],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingr
edient]"
"ALK-Abello, Inc." FELIS CATUS SKIN 10000 [BAU]/mL "Standar
dized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell
-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],
ON DRUG "Bermuda Grass, Standardized" "Bermuda Grass, Standardized"
"ALK-Abello, Inc." CYNODON DACTYLON POLLEN 10000 [BAU]/mL "Standar
ass (June), Standardized" SOLUTION PERCUTANEOUS 19971218
ass (June), Standardized" SOLUTION PERCUTANEOUS 19971218
andardized" SOLUTION PERCUTANEOUS 19971218 BLA
BLA103053 "ALK-Abello, Inc." FESTUCA PRATENSIS POLLEN 100000
BLA103053 "ALK-Abello, Inc." FESTUCA PRATENSIS POLLEN 10000
"ALK-Abello, Inc." ALLERGENIC EXTRACT- ORCHARD GRASS DACTYLIS GLOMERATA
"ALK-Abello, Inc." ALLERGENIC EXTRACT- ORCHARD GRASS DACTYLIS GLOMERATA
"ALK-Abello, Inc." AGROSTIS GIGANTEA POLLEN 100000 [BAU]/mL
dient]"
"ALK-Abello, Inc." AGROSTIS GIGANTEA POLLEN 10000 [BAU]/mL
dient]"
BLA103056 "ALK-Abello, Inc." "ALLERGENIC EXTRACT- RYEGRASS, PERENNIAL
LOLIUM PERENNE" 100000 [BAU]/mL "Standardized Pollen Allergenic
ased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingred
ient]"
BLA103056 "ALK-Abello, Inc." "ALLERGENIC EXTRACT- RYEGRASS, PERENNIAL
LOLIUM PERENNE" 10000 [BAU]/mL "Standardized Pollen Allergenic
ient]"
ndardized" SOLUTION PERCUTANEOUS 19971218 BLA
BLA103057 "ALK-Abello, Inc." ANTHOXANTHUM ODORATUM POLLEN 100000
ndardized" SOLUTION PERCUTANEOUS 19971218 BLA
BLA103057 "ALK-Abello, Inc." ANTHOXANTHUM ODORATUM POLLEN 10000
ON DRUG "Timothy, Standardized" "Timothy, Standardized" SOLUTION
PERCUTANEOUS 19971218 BLA BLA103058 "ALK-Abello, Inc
." PHLEUM PRATENSE POLLEN 100000 [BAU]/mL "Standardized Pollen All
l/Ingredient]"
ON DRUG "Timothy, Standardized" "Timothy, Standardized" SOLUTION
." PHLEUM PRATENSE POLLEN 10000 [BAU]/mL "Standardized Pollen All
l/Ingredient]"
0268-6000_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6000 NON-STANDARDIZED
mical/Ingredient]"
INTRADERMAL 19650101 BLA BLA103753 "ALK-Abello, Inc
mical/Ingredient]"
ALLERGENIC ALMOND Almond Food "INJECTION, SOLUTION" PERCUTAN
EOUS 19650101 BLA BLA103753 "ALK-Abello, Inc."
ALMOND 0.1 g/mL "Non-Standardized Food Allergenic Extract [EPC],Increase
ent],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient]"
ALLERGENIC APPLE Apple Food "INJECTION, SOLUTION" PERCUTAN
APPLE 0.1 g/mL "Allergens [Chemical/Ingredient],Dietary Proteins [Chemi
cal/Ingredient],Fruit Proteins [Chemical/Ingredient],Non-Standardized Food Aller
genic Extract [EPC],Increased Histamine Release [PE]"
ALLERGENIC APRICOT Apricot "INJECTION, SOLUTION" PERCUTANEOUS
19650101 BLA BLA103753 "ALK-Abello, Inc." APRICOT
ine Release [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingr
edient],Fruit Proteins [Chemical/Ingredient]"
ALLERGENIC ASPARAGUS Asparagus "INJECTION, SOLUTION"
." ASPARAGUS 0.1 g/mL "Non-Standardized Food Allergenic Extrac
t [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [
Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [
Chemical/Ingredient]"
ALLERGENIC AVOCADO Avocado "INJECTION, SOLUTION" PERCUTANEOUS
19650101 BLA BLA103753 "ALK-Abello, Inc." AVOCADO
tary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient]"
ALLERGENIC BANANA Banana "INJECTION, SOLUTION" PERCUTANEOUS
19650101 BLA BLA103753 "ALK-Abello, Inc." BANANA
ALLERGENIC BARLEY Barley Food "INJECTION, SOLUTION" PERCUTAN
BARLEY 0.1 g/mL "Non-Standardized Food Allergenic Extract [EPC],Increase
ent],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient]
"
ALLERGENIC BEAN Pinto Bean Kidney Bean "INJECTION, SOLUTION"
." BEAN 0.1 g/mL "Non-Standardized Food Allergenic Extract [EPC],
Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical
/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical
/Ingredient]"
ALLERGENIC STRING BEAN String Bean Green Bean "INJECTION, SOLU
TION" PERCUTANEOUS 19650101 BLA BLA103753 "ALK-Abe
llo, Inc." STRING BEAN 0.1 g/mL "Non-Standardized Food Allergeni
c Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],All
ergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Protei
ALLERGENIC BEEF Beef "INJECTION, SOLUTION" PERCUTANEOUS
19650101 BLA BLA103753 "ALK-Abello, Inc." BEEF
ALLERGENIC BRAZIL NUT Brazil Nut "INJECTION, SOLUTION"
." BRAZIL NUT 0.1 g/mL "Non-Standardized Food Allergenic Extrac
Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemic
al/Ingredient]"
ALLERGENIC BROCCOLI Broccoli "INJECTION, SOLUTION"
." BROCCOLI 0.1 g/mL "Non-Standardized Food Allergenic Extrac
ALLERGENIC BUCKWHEAT Buckwheat "INJECTION, SOLUTION"
." BUCKWHEAT 0.1 g/mL "Non-Standardized Food Allergenic Extrac
Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chem
ical/Ingredient]"
ALLERGENIC CABBAGE Cabbage "INJECTION, SOLUTION" PERCUTANEOUS
19650101 BLA BLA103753 "ALK-Abello, Inc." CABBAGE
tary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient]"
ALLERGENIC CANTALOUPE Cantaloupe "INJECTION, SOLUTION"
." CANTALOUPE 0.1 g/mL "Non-Standardized Food Allergenic Extrac
Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chem
ical/Ingredient]"
ALLERGENIC CARROT Carrot "INJECTION, SOLUTION" PERCUTANEOUS
19650101 BLA BLA103753 "ALK-Abello, Inc." CARROT
ALLERGENIC CASEIN Casein "INJECTION, SOLUTION" PERCUTANEOUS
19650101 BLA BLA103753 "ALK-Abello, Inc." CASEIN
tary Proteins [Chemical/Ingredient],Caseins [Chemical/Ingredient]"
ALLERGENIC CELERY Celery "INJECTION, SOLUTION" PERCUTANEOUS
19650101 BLA BLA103753 "ALK-Abello, Inc." CELERY
ALLERGENIC CHERRY Cherry "INJECTION, SOLUTION" PERCUTANEOUS
19650101 BLA BLA103753 "ALK-Abello, Inc." CHERRY
ALLERGENIC CHICKEN Chicken Meat "INJECTION, SOLUTION" PERCUTAN
CHICKEN 0.1 g/mL "Non-Standardized Food Allergenic Extract [EPC],Increase
ent],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Chemical/Ingredien
t]"
ALLERGENIC CINNAMON Cinnamon "INJECTION, SOLUTION"
." CINNAMON 0.1 g/mL "Non-Standardized Food Allergenic Extrac
t [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Pro
teins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Allergens [Chem
ical/Ingredient]"
ALLERGENIC CLAM Clam "INJECTION, SOLUTION" PERCUTANEOUS
19650101 BLA BLA103753 "ALK-Abello, Inc." CLAM
tary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient]"
ALLERGENIC COCOA BEAN Cocoa Bean Whole Bean Chocolate "INJECTI
ON, SOLUTION" PERCUTANEOUS 19650101 BLA BLA103753
"ALK-Abello, Inc." COCOA BEAN 0.1 g/mL "Non-Standardized Food A
llergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity
[PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plan
t Proteins [Chemical/Ingredient]"
ALLERGENIC COCONUT Coconut "INJECTION, SOLUTION" PERCUTANEOUS
19650101 BLA BLA103753 "ALK-Abello, Inc." COCONUT
ALLERGENIC CODFISH Codfish "INJECTION, SOLUTION" PERCUTANEOUS
19650101 BLA BLA103753 "ALK-Abello, Inc." CODFISH
tary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient]
"
ALLERGENIC COFFEE BEAN Coffee "INJECTION, SOLUTION" PERCUTAN
COFFEE BEAN 0.1 g/mL "Non-Standardized Food Allergenic Extract [EPC],
/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ing
redient]"
ALLERGENIC CRAB Crab "INJECTION, SOLUTION" PERCUTANEOUS
19650101 BLA BLA103753 "ALK-Abello, Inc." CRAB
ALLERGENIC CUCUMBER Cucumber "INJECTION, SOLUTION"
." CUCUMBER 0.1 g/mL "Non-Standardized Food Allergenic Extrac
ALLERGENIC EGG WHITE Egg White "INJECTION, SOLUTION"
." EGG WHITE 0.01 g/mL "Cell-mediated Immunity [PE],Non-Standar
dized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Allergens [
Chemical/Ingredient],Egg Proteins, Dietary [Chemical/Ingredient],Dietary Protein
ALLERGENIC EGG Whole Egg "INJECTION, SOLUTION" PERCUTAN
EGG 0.01 g/mL "Non-Standardized Food Allergenic Extract [EPC],Increase
ent],Dietary Proteins [Chemical/Ingredient],Egg Proteins, Dietary [Chemical/Ingr
edient]"
ALLERGENIC EGG YOLK Egg Yolk "INJECTION, SOLUTION"
." EGG YOLK 0.01 g/mL "Non-Standardized Food Allergenic Extrac
Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Egg Proteins, Dietar
y [Chemical/Ingredient]"
ALLERGENIC FLOUNDER Flounder "INJECTION, SOLUTION"
." FLOUNDER 0.1 g/mL "Non-Standardized Food Allergenic Extrac
Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dieta
ry [Chemical/Ingredient]"
ALLERGENIC GARLIC Garlic "INJECTION, SOLUTION" PERCUTANEOUS
19650101 BLA BLA103753 "ALK-Abello, Inc." GARLIC
tary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient]"
ALLERGENIC GRAPE White Seedless Grape "INJECTION, SOLUTION"
." GRAPE 0.1 g/mL "Non-Standardized Food Allergenic Extract [EPC],
/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ing
redient]"
ALLERGENIC GRAPEFRUIT Grapefruit "INJECTION, SOLUTION"
." GRAPEFRUIT 0.1 g/mL "Non-Standardized Food Allergenic Extrac
ical/Ingredient]"
ALLERGENIC KARAYA GUM Karaya Gum Bassora "INJECTION, SOLU
llo, Inc." KARAYA GUM 0.005 g/mL "Non-Standardized Food Allergeni
c Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Inc
reased IgG Production [PE],Dietary Proteins [Chemical/Ingredient],Food Additives
ALLERGENIC HONEYDEW MELON Honeydew "INJECTION, SOLUTION"
." HONEYDEW MELON 0.1 g/mL "Non-Standardized Food Allergenic Extrac
ical/Ingredient]"
ALLERGENIC LAMB Lamb "INJECTION, SOLUTION" PERCUTANEOUS
19650101 BLA BLA103753 "ALK-Abello, Inc." LAMB
ALLERGENIC LEMON Lemon "INJECTION, SOLUTION" PERCUTANEOUS
19650101 BLA BLA103753 "ALK-Abello, Inc." LEMON
ALLERGENIC LETTUCE Lettuce "INJECTION, SOLUTION" PERCUTANEOUS
19650101 BLA BLA103753 "ALK-Abello, Inc." LETTUCE
ALLERGENIC LIMA BEAN Lima Bean "INJECTION, SOLUTION"
." LIMA BEAN 0.1 g/mL "Non-Standardized Food Allergenic Extrac
Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chem
ical/Ingredient]"
ALLERGENIC LOBSTER Lobster "INJECTION, SOLUTION" PERCUTANEOUS
19650101 BLA BLA103753 "ALK-Abello, Inc." LOBSTER
ALLERGENIC GOAT MILK Goat Milk "INJECTION, SOLUTION"
." GOAT MILK 0.1 g/mL "Non-Standardized Food Allergenic Extrac
Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Milk Proteins [Chemi
cal/Ingredient]"
ALLERGENIC COW MILK Milk Whole Cows "INJECTION, SOLUTION"
." COW MILK 0.1 g/mL "Non-Standardized Food Allergenic Extrac
Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Milk Proteins [Chemi
cal/Ingredient]"
ALLERGENIC MUSHROOM Mushroom Agaricus spp "INJECTION, SOLU
llo, Inc." CULTIVATED MUSHROOM 0.1 g/mL "Non-Standardized Food A
[PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fung
al Proteins [Chemical/Ingredient]"
ALLERGENIC MUSTARD SEED Mustard Seed "INJECTION, SOLUTION"
." MUSTARD SEED 0.1 g/mL "Non-Standardized Plant Allergenic Extra
ct [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Rele
ase [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Ch
emical/Ingredient],Food Additives [Chemical/Ingredient],Dietary Proteins [Chemic
al/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemi
cal/Ingredient]"
ALLERGENIC OAT Oat Grain "INJECTION, SOLUTION" PERCUTAN
OAT 0.1 g/mL "Non-Standardized Food Allergenic Extract [EPC],Increase
"
ALLERGENIC BLACK OLIVE Olive "INJECTION, SOLUTION" PERCUTAN
BLACK OLIVE 0.1 g/mL "Non-Standardized Food Allergenic Extract [EPC],
redient]"
ALLERGENIC ONION Onion "INJECTION, SOLUTION" PERCUTANEOUS
19650101 BLA BLA103753 "ALK-Abello, Inc." ONION
ALLERGENIC ORANGE Orange "INJECTION, SOLUTION" PERCUTANEOUS
19650101 BLA BLA103753 "ALK-Abello, Inc." ORANGE
ALLERGENIC OYSTER Oyster "INJECTION, SOLUTION" PERCUTANEOUS
19650101 BLA BLA103753 "ALK-Abello, Inc." OYSTER
ALLERGENIC PEA Green Pea English "INJECTION, SOLUTION"
." PEA 0.1 g/mL "Non-Standardized Food Allergenic Extract [EPC],
/Ingredient]"
ALLERGENIC PEACH Peach "INJECTION, SOLUTION" PERCUTANEOUS
19650101 BLA BLA103753 "ALK-Abello, Inc." PEACH
ALLERGENIC PEANUT Peanut "INJECTION, SOLUTION" PERCUTANEOUS
19650101 BLA BLA103753 "ALK-Abello, Inc." PEANUT
tary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient]"
ALLERGENIC PEAR Pear "INJECTION, SOLUTION" PERCUTANEOUS
19650101 BLA BLA103753 "ALK-Abello, Inc." PEAR
ALLERGENIC PECAN Pecan "INJECTION, SOLUTION" PERCUTANEOUS
19650101 BLA BLA103753 "ALK-Abello, Inc." PECAN
tary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient]"
ALLERGENIC GREEN BELL PEPPER Bell "INJECTION, SOLUTION"
." GREEN BELL PEPPER 0.1 g/mL "Non-Standardized Food Allergeni
ergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Pr
oteins [Chemical/Ingredient]"
ALLERGENIC BLACK PEPPER Black Pepper "INJECTION, SOLUTION"
." BLACK PEPPER 0.1 g/mL "Non-Standardized Food Allergenic Extrac
ALLERGENIC PINEAPPLE Pineapple "INJECTION, SOLUTION"
." PINEAPPLE 0.1 g/mL "Non-Standardized Food Allergenic Extrac
ical/Ingredient]"
ALLERGENIC PISTACHIO Pistachio Nut "INJECTION, SOLUTION"
." PISTACHIO 0.1 g/mL "Non-Standardized Food Allergenic Extrac
al/Ingredient]"
ALLERGENIC PLUM Plum "INJECTION, SOLUTION" PERCUTANEOUS
19650101 BLA BLA103753 "ALK-Abello, Inc." PLUM
ALLERGENIC PORK Pork "INJECTION, SOLUTION" PERCUTANEOUS
19650101 BLA BLA103753 "ALK-Abello, Inc." PORK
ALLERGENIC POTATO Sweet Potato "INJECTION, SOLUTION" PERCUTAN
POTATO 0.1 g/mL "Non-Standardized Food Allergenic Extract [EPC],Increase
ent],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredi
ent]"
ALLERGENIC POTATO White Potato "INJECTION, SOLUTION" PERCUTAN
POTATO 0.1 g/mL "Non-Standardized Food Allergenic Extract [EPC],Increase
ent],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredi
ent]"
ALLERGENIC RICE Rice "INJECTION, SOLUTION" PERCUTANEOUS
19650101 BLA BLA103753 "ALK-Abello, Inc." RICE
tary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient]"
ALLERGENIC RYE Rye "INJECTION, SOLUTION" PERCUTANEOUS
19650101 BLA BLA103753 "ALK-Abello, Inc." RYE
tary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient]"
ALLERGENIC SALMON Salmon "INJECTION, SOLUTION" PERCUTANEOUS
19650101 BLA BLA103753 "ALK-Abello, Inc." SALMON
"
ALLERGENIC SESAME SEED Sesame Seed "INJECTION, SOLUTION"
." SESAME SEED 0.1 g/mL "Non-Standardized Food Allergenic Extrac
Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Seed Storage Protein
s [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient]"
ALLERGENIC SHRIMP Shrimp "INJECTION, SOLUTION" PERCUTANEOUS
19650101 BLA BLA103753 "ALK-Abello, Inc." SHRIMP
ALLERGENIC SOYBEAN Soybean "INJECTION, SOLUTION" PERCUTANEOUS
19650101 BLA BLA103753 "ALK-Abello, Inc." SOYBEAN
ALLERGENIC SPINACH Spinach "INJECTION, SOLUTION" PERCUTANEOUS
19650101 BLA BLA103753 "ALK-Abello, Inc." SPINACH
ALLERGENIC SQUASH Squash "INJECTION, SOLUTION" PERCUTANEOUS
19650101 BLA BLA103753 "ALK-Abello, Inc." SQUASH
ALLERGENIC STRAWBERRY Strawberry "INJECTION, SOLUTION"
." STRAWBERRY 0.1 g/mL "Non-Standardized Food Allergenic Extrac
ical/Ingredient]"
ALLERGENIC CORN Sweet Corn "INJECTION, SOLUTION" PERCUTAN
CORN 0.1 g/mL "Non-Standardized Food Allergenic Extract [EPC],Increase
"
ALLERGENIC TOMATO Tomato "INJECTION, SOLUTION" PERCUTANEOUS
19650101 BLA BLA103753 "ALK-Abello, Inc." TOMATO
ALLERGENIC TUNA Tuna "INJECTION, SOLUTION" PERCUTANEOUS
19650101 BLA BLA103753 "ALK-Abello, Inc." TUNA
"
ALLERGENIC TURKEY Turkey Meat "INJECTION, SOLUTION" PERCUTAN
TURKEY 0.1 g/mL "Non-Standardized Food Allergenic Extract [EPC],Increase
ent],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Chemical/Ingredien
t]"
ALLERGENIC VANILLA Vanilla "INJECTION, SOLUTION" PERCUTANEOUS
19650101 BLA BLA103753 "ALK-Abello, Inc." VANILLA
ine Release [PE],Cell-mediated Immunity [PE],Food Additives [Chemical/Ingredient
],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
ALLERGENIC ENGLISH WALNUT English Walnut "INJECTION, SOLUTION"
." ENGLISH WALNUT 0.1 g/mL "Non-Standardized Food Allergenic Extrac
al/Ingredient]"
ALLERGENIC WATERMELON Watermelon "INJECTION, SOLUTION"
." WATERMELON 0.1 g/mL "Non-Standardized Food Allergenic Extrac
ical/Ingredient]"
ALLERGENIC WHEAT Whole Wheat Wheat Grain "INJECTION, SOLUTION"
." WHEAT 0.1 g/mL "Non-Standardized Food Allergenic Extract [EPC],
/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ing
redient]"
ALLERGENIC BOS TAURUS SKIN Cattle Epithelium "INJECTION, SOLU
ALLERGENIC BOS TAURUS SKIN Cattle Epithelium "INJECTION, SOLU
TION" INTRADERMAL 19650101 BLA BLA103753 "ALK-Abe
ALLERGENIC COTTON FIBER Cattle Epithelium "INJECTION, SOLU
llo, Inc." COTTON FIBER 0.05 g/mL "Non-Standardized Plant Fiber Al
ALLERGENIC COTTON FIBER Cotton Linters "INJECTION, SOLUTION"
." COTTON FIBER 0.001 g/mL "Non-Standardized Plant Fiber Allergenic
eased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemic
al/Ingredient]"
ALLERGENIC COTTON SEED Cottonseed "INJECTION, SOLUTION"
." COTTON SEED 0.05 g/mL "Non-Standardized Plant Allergenic Extra
IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ing
redient],Seed Storage Proteins [Chemical/Ingredient]"
ALLERGENIC CANIS LUPUS FAMILIARIS SKIN Dog Epithelium "INJECTI
ON, SOLUTION" INTRADERMAL 19650101 BLA BLA103753
ALLERGENIC CANIS LUPUS FAMILIARIS SKIN Dog Epithelium "INJECTI
ALLERGENIC CAVIA PORCELLUS SKIN Guinea Pig Epithelium "INJECTI
"ALK-Abello, Inc." CAVIA PORCELLUS SKIN 1000 [PNU]/mL "Non-Sta
ALLERGENIC CAVIA PORCELLUS SKIN Guinea Pig Epithelium "INJECTI
ALLERGENIC EQUUS CABALLUS SKIN Horse Epithelium "INJECTI
"ALK-Abello, Inc." EQUUS CABALLUS SKIN 1000 [PNU]/mL "Non-Sta
ALLERGENIC EQUUS CABALLUS SKIN Horse Epithelium "INJECTI
"ALK-Abello, Inc." EQUUS CABALLUS SKIN 0.05 g/mL "Non-Standardize
ALLERGENIC CEIBA PENTANDRA FIBER Kapok "INJECTION, SOLUTION"
." CEIBA PENTANDRA FIBER 0.05 g/mL "Non-Standardized Plant Fiber Al
ALLERGENIC MUS MUSCULUS SKIN Mouse Epithelium "INJECTI
"ALK-Abello, Inc." MUS MUSCULUS SKIN 0.05 g/mL "Non-Standardize
ALLERGENIC MUS MUSCULUS SKIN Mouse Epithelium "INJECTI
"ALK-Abello, Inc." MUS MUSCULUS SKIN 1000 [PNU]/mL "Non-Sta
ALLERGENIC ORRIS Orris Root "INJECTION, SOLUTION" PERCUTAN
ORRIS 0.05 g/mL
ALLERGENIC PYRETHRUM CINERARIIFOLIUM Pyrethrum "INJECTI
"ALK-Abello, Inc." PYRETHRUM CINERARIIFOLIUM 0.05 g/mL "Non-Sta
ndardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-m
ediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredie
nt],Plant Proteins [Chemical/Ingredient]"
ALLERGENIC RABBIT Rabbit Epithelium "INJECTION, SOLUTION"
." RABBIT 1000 [PNU]/mL "Non-Standardized Food Allergenic Extrac
Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemi
cal/Ingredient]"
ALLERGENIC RABBIT Rabbit Epithelium "INJECTION, SOLUTION"
." RABBIT 0.05 g/mL "Non-Standardized Food Allergenic Extract [EPC],
/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingr
edient]"
ALLERGENIC SOLENOPSIS INVICTA Fire Ant "INJECTION, SOLU
llo, Inc." SOLENOPSIS INVICTA 0.01 g/mL "Non-Standardized Insect
Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated I
mmunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient]
,Ant Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
ALLERGENIC SOLENOPSIS INVICTA Fire Ant "INJECTION, SOLU
llo, Inc." SOLENOPSIS INVICTA 10 [PNU]/mL "Non-Standardize
d Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-me
diated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ing
redient],Ant Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
ALLERGENIC PERIPLANETA AMERICANA American Cockroach "INJECTI
ALLERGENIC PERIPLANETA AMERICANA American Cockroach "INJECTI
ALLERGENIC BLATELLA GERMANICA German Cockroach "INJECTI
ALLERGENIC BLATELLA GERMANICA German Cockroach "INJECTI
"ALK-Abello, Inc." ACREMONIUM STRICTUM 0.1 g/mL "Non-Standardize
ALLERGENIC ACREMONIUM STRICTUM Acremonium Cephalosporium
"INJECTION, SOLUTION" INTRADERMAL 19650101 BLA BLA10375
3 "ALK-Abello, Inc." ACREMONIUM STRICTUM 1000 [PNU]/mL
ALLERGENIC ALTERNARIA TENUIS Alternaria tenuis A alternata
"INJECTION, SOLUTION" PERCUTANEOUS 19650101 BLA BLA10375
3 "ALK-Abello, Inc." ALTERNARIA ALTERNATA 0.1 g/mL "Non-Sta
ALLERGENIC ALTERNARIA TENUIS Alternaria tenuis A alternata
3 "ALK-Abello, Inc." ALTERNARIA ALTERNATA 1000 [PNU]/mL
ALLERGENIC ASPERGILLUS FUMIGATUS Aspergillus Fumigatus "INJECTI
ent]"
ALLERGENIC ASPERGILLUS FUMIGATUS Aspergillus Fumigatus "INJECTI
/Ingredient]"
ALLERGENIC ASPERGILLUS NIGER VAR NIGER Aspergillus Niger
3 "ALK-Abello, Inc." ASPERGILLUS NIGER VAR. NIGER 0.1 g/mL
ALLERGENIC ASPERGILLUS NIGER VAR NIGER Aspergillus Niger
LANS "INJECTION, SOLUTION" PERCUTANEOUS 19650101 BLA
ALLERGENIC AUREOBASIDIUM PULLULANS VAR PULLULANS Aureobasidium Pu
llularia Pullulans "INJECTION, SOLUTION" INTRADERMAL 19650101
BLA BLA103753 "ALK-Abello, Inc." AUREOBASIDIUM PULLULANS VAR. PUL
LUTANS 1000 [PNU]/mL "Non-Standardized Fungal Allergenic Extract [EPC
duction [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredien
t]"
ALLERGENIC BOTRYTIS CINEREA Botrytis cinerea "INJECTI
"ALK-Abello, Inc." BOTRYTIS CINEREA 0.1 g/mL "Non-Standardize
ALLERGENIC BOTRYTIS CINEREA Botrytis cinerea "INJECTI
ALLERGENIC CANDIDA ALBICANS Candida albicans "INJECTI
ALLERGENIC CANDIDA ALBICANS Candida albicans "INJECTI
ALLERGENIC CHAETOMIUM GLOBOSUM Chaetomium globosum "INJECTI
"ALK-Abello, Inc." CHAETOMIUM GLOBOSUM 0.1 g/mL "Non-Standardize
ALLERGENIC CHAETOMIUM GLOBOSUM Chaetomium globosum "INJECTI
ALLERGENIC CLADOSPORIUM CLADOSPORIOIDES Cladosporium Cladosporio
ides Hormodendrum Clad "INJECTION, SOLUTION" PERCUTANEOUS 19650101
BLA BLA103753 "ALK-Abello, Inc." CLADOSPORIUM CLADOSPORIOIDES
ALLERGENIC CLADOSPORIUM CLADOSPORIOIDES Cladosporium Cladosporio
ides Hormodendrum Clad "INJECTION, SOLUTION" INTRADERMAL 19650101
BLA BLA103753 "ALK-Abello, Inc." CLADOSPORIUM CLADOSPORIOIDES
ALLERGENIC CLADOSPORIUM SPHAEROSPERMUM Cladosporium Sphaerosper
mum Hormodendrum Hordei "INJECTION, SOLUTION" PERCUTANEOUS 19650101
BLA BLA103753 "ALK-Abello, Inc." CLADOSPORIUM SPHAEROSPERMUM
ALLERGENIC CLADOSPORIUM SPHAEROSPERMUM Cladosporium Sphaerosper
mum Hormodendrum Hordei "INJECTION, SOLUTION" INTRADERMAL 19650101
BLA BLA103753 "ALK-Abello, Inc." CLADOSPORIUM SPHAEROSPERMUM
3 "ALK-Abello, Inc." COCHLIOBOLUS SATIVUS 0.1 g/mL "Non-Sta
ALLERGENIC COCHLIOBOLUS SATIVUS Drechslera Helminthosporium
ALLERGENIC EPICOCCUM NIGRUM Epicoccum nigrum "INJECTI
ALLERGENIC EPICOCCUM NIGRUM Epicoccum nigrum "INJECTI
ALLERGENIC FUSARIUM OXYSPORUM VASINFECTUM Fusarium spp "INJECTI
"ALK-Abello, Inc." FUSARIUM OXYSPORUM VASINFECTUM 0.1 g/mL "Non-Sta
ALLERGENIC FUSARIUM OXYSPORUM VASINFECTUM Fusarium spp "INJECTI
"ALK-Abello, Inc." FUSARIUM OXYSPORUM VASINFECTUM 1000 [PNU]/mL
ALLERGENIC HELMINTHOSPORIUM SOLANI Helminthosporium solani Spondylo
cladium "INJECTION, SOLUTION" PERCUTANEOUS 19650101 BLA
BLA103753 "ALK-Abello, Inc." HELMINTHOSPORIUM SOLANI 0.1 g/mL
ALLERGENIC HELMINTHOSPORIUM SOLANI Helminthosporium solani Spondylo
cladium "INJECTION, SOLUTION" INTRADERMAL 19650101 BLA
BLA103753 "ALK-Abello, Inc." HELMINTHOSPORIUM SOLANI 1000 [PNU]/mL
ALLERGENIC MUCOR PLUMBEUS Mucor spp "INJECTION, SOLUTION"
." MUCOR PLUMBEUS 0.1 g/mL "Non-Standardized Fungal Allergenic Extr
ngredient]"
ALLERGENIC MUCOR PLUMBEUS HelminthMucor spp "INJECTION, SOLU
llo, Inc." MUCOR PLUMBEUS 1000 [PNU]/mL "Non-Standardized Fungal
y [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Aller
gens [Chemical/Ingredient]"
ALLERGENIC NEUROSPORA INTERMEDIA Neurospora spp "INJECTION, SOLU
llo, Inc." NEUROSPORA INTERMEDIA 0.1 g/mL "Non-Standardized Fungal
ALLERGENIC NEUROSPORA INTERMEDIA Neurospora spp "INJECTION, SOLU
llo, Inc." NEUROSPORA INTERMEDIA 1000 [PNU]/mL "Non-Standardize
ALLERGENIC KHUSKIA ORYZAE Nigrospora spp "INJECTION, SOLUTION"
." KHUSKIA ORYZAE 0.1 g/mL "Non-Standardized Fungal Allergenic Extr
ngredient]"
ALLERGENIC PHOMA EXIGUA VAR EXIGUA Phoma herbarum "INJECTION, SOLU
llo, Inc." PHOMA EXIGUA VAR. EXIGUA 0.1 g/mL "Non-Standardize
ALLERGENIC PHOMA EXIGUA VAR EXIGUA Phoma herbarum "INJECTION, SOLU
ALLERGENIC RHIZOPUS ARRHIZUS VAR ARRHIZUS Rhizopus spp "INJECTI
"ALK-Abello, Inc." RHIZOPUS ARRHIZUS VAR. ARRHIZUS 0.1 g/mL "Non-Sta
ALLERGENIC RHIZOPUS ARRHIZUS VAR ARRHIZUS Rhizopus spp "INJECTI
"ALK-Abello, Inc." RHIZOPUS ARRHIZUS VAR. ARRHIZUS 1000 [PNU]/mL
ALLERGENIC RHODOTORULA RUBRA Rhodotorula Rubra "INJECTI
"ALK-Abello, Inc." RHODOTORULA RUBRA 0.1 g/mL "Non-Standardize
ALLERGENIC RHODOTORULA RUBRA Rhodotorula Rubra "INJECTI
ALLERGENIC USTILAGO MAYDIS Corn Smut "INJECTION, SOLUTION"
ngredient]"
ALLERGENIC USTILAGO TRITICI Wheat Smut "INJECTION, SOLU
llo, Inc." USTILAGO TRITICI 0.05 g/mL "Non-Standardized Fungal
ALLERGENIC STEMPHYLIUM SOLANI Stemphylium spp "INJECTION, SOLU
llo, Inc." STEMPHYLIUM SOLANI 0.1 g/mL "Non-Standardized Fungal
ALLERGENIC STEMPHYLIUM SOLANI Stemphylium spp "INJECTION, SOLU
llo, Inc." STEMPHYLIUM SOLANI 1000 [PNU]/mL "Non-Standardize
ALLERGENIC TRICHOPHYTON MENTAGROPHYTES Trichophyton Mentagrophy
tes "INJECTION, SOLUTION" PERCUTANEOUS 19650101 BLA
BLA103753 "ALK-Abello, Inc." TRICHOPHYTON MENTAGROPHYTES 0.1
ALLERGENIC TRICHOPHYTON MENTAGROPHYTES Trichophyton Mentagrophy
tes "INJECTION, SOLUTION" INTRADERMAL 19650101 BLA
ALLERGENIC PENICILLIUM CHRYSOGENUM VAR CHRYSOGENUM Yeast Saccharomy
ces cerevisiae "INJECTION, SOLUTION" PERCUTANEOUS 19650101
BLA BLA103753 "ALK-Abello, Inc." PENICILLIUM CHRYSOGENUM VAR. CHR
YSOGENUM 0.1 g/mL "Non-Standardized Fungal Allergenic Extract [EPC
t]"
ALLERGENIC SACCHAROMYCES CEREVISIAE Yeast Saccharomyces cere
visiae "INJECTION, SOLUTION" INTRADERMAL 19650101 BLA
BLA103753 "ALK-Abello, Inc." SACCHAROMYCES CEREVISIAE 1000
amine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],All
ergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardi
zed Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EP
C],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins
[Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical
/Ingredient]"
ALLERGENIC ACACIA Acacia "INJECTION, SOLUTION" PERCUTANEOUS
ALLERGENIC ALNUS INCANA SSP RUGOSA POLLEN White Alder "INJECTI
." MEDICAGO SATIVA POLLEN 0.05 g/mL "Non-Standardized Pollen Allerge
gredient]"
ALLERGENIC FRAXINUS AMERICANA POLLEN White Ash "INJECTI
mical/Ingredient]"
ALLERGENIC BETULA LENTA POLLEN Black Birch "INJECTION, SOLU
mical/Ingredient]"
ALLERGENIC BETULA NIGRA POLLEN River Birch Red "INJECTION, SOLU
mical/Ingredient]"
ALLERGENIC BETULA LENTA POLLEN White Birch "INJECTION, SOLU
mical/Ingredient]"
nt]"
ALLERGENIC JUNIPERUS ASHEI POLLEN Mountain Cedar "INJECTION, SOLU
mical/Ingredient]"
ALLERGENIC JUNIPERUS VIRGINIANA POLLEN Red Cedar "INJECTI
r "INJECTION, SOLUTION" PERCUTANEOUS 19650101 BLA
ALLERGENIC POPULUS DELTOIDES POLLEN Eastern Cottonwood Commo
n "INJECTION, SOLUTION" PERCUTANEOUS 19650101 BLA
ALLERGENIC CUPRESSUS ARIZONICA POLLEN Arizona Cypress "INJECTI
ALLERGENIC TAXODIUM DISTICHUM POLLEN Bald Cypress "INJECTI
ALLERGENIC RUMEX ACETOSELLA POLLEN Sour Dock Sheep Sorrel "INJECTI
ALLERGENIC RUMEX CRISPUS POLLEN Yellow Dock "INJECTION, SOLU
mical/Ingredient]"
ALLERGENIC ULMUS AMERICANA POLLEN American Elm "INJECTION, SOLU
mical/Ingredient]"
ALLERGENIC CARYA OVATA POLLEN Shagbark Hickory "INJECTI
"ALK-Abello, Inc." CARYA OVATA POLLEN 0.05 g/mL "Non-Standardize
ALLERGENIC JUNIPERUS CALIFORNICA POLLEN Western Juniper "INJECTI
mical/Ingredient]"
ALLERGENIC ACER RUBRUM POLLEN Red Maple "INJECTION, SOLU
mical/Ingredient]"
ALLERGENIC ACER SACCHARUM POLLEN Sugar Maple "INJECTION, SOLU
mical/Ingredient]"
ALLERGENIC IVA XANTHIFOLIA POLLEN Burweed Marshelder "INJECTI
ALLERGENIC IVA ANNUA VAR ANNUA POLLEN Rough Marshelder
ALLERGENIC ARTEMISIA VULGARIS POLLEN Common Mugwort "INJECTI
nt]"
ALLERGENIC MORUS RUBRA POLLEN Red Mulberry "INJECTION, SOLU
mical/Ingredient]"
ALLERGENIC MORUS ALBA POLLEN White Mulberry "INJECTION, SOLU
mical/Ingredient]"
ALLERGENIC QUERCUS RUBRA POLLEN Red Oak "INJECTION, SOLUTION"
gredient]"
ALLERGENIC QUERCUS VIRGINIANA POLLEN Virginia Live Oak
ALLERGENIC QUERCUS ALBA POLLEN White Oak "INJECTION, SOLU
mical/Ingredient]"
mical/Ingredient]"
ALLERGENIC SYAGRUS ROMANZOFFIANA POLLEN Queen Palm Coco Palm
ALLERGENIC AMARANTHUS RETROFLEXUS POLLEN Rough Pigweed "INJECTI
"ALK-Abello, Inc." AMARANTHUS RETROFLEXUS POLLEN 0.05 g/mL "Non-Sta
nt]"
ALLERGENIC PINUS STROBUS POLLEN White Pine "INJECTION, SOLU
mical/Ingredient]"
ALLERGENIC PLANTAGO LANCEOLATA POLLEN English Plantain
ALLERGENIC POPULUS ALBA POLLEN White Poplar "INJECTION, SOLU
mical/Ingredient]"
mical/Ingredient]"
ALLERGENIC AMBROSIA TRIFIDA POLLEN Tall Ragweed Giant "INJECTI
mical/Ingredient]"
ALLERGENIC ARTEMISIA TRIDENTATA POLLEN Common Sagebrush
Ingredient]"
ALLERGENIC PLATANUS OCCIDENTALIS POLLEN American Sycamore
ALLERGENIC JUGLANS NIGRA POLLEN Black Pollen Walnut "INJECTI
ALLERGENIC ACACIA Acacia "INJECTION, SOLUTION" INTRADERMAL
1000 [PNU]/mL "Non-Standardized Plant Allergenic Extract [EPC],Increas
ed Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [
PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
ALLERGENIC AILANTHUS ALTISSIMA POLLEN Ailanthus Tree of Heaven
3 "ALK-Abello, Inc." AILANTHUS ALTISSIMA POLLEN 0.05 g/mL
ALLERGENIC ALNUS INCANA SSP RUGOSA POLLEN White Alder "INJECTI
"ALK-Abello, Inc." ALNUS INCANA SUBSP. RUGOSA POLLEN 1000 [PNU]/mL
ALLERGENIC FRAXINUS VELUTINA POLLEN Arizona Ash "INJECTI
"ALK-Abello, Inc." FRAXINUS VELUTINA POLLEN 1000 [PNU]/mL
ALLERGENIC FRAXINUS AMERICANA POLLEN White Ash "INJECTI
"ALK-Abello, Inc." MORELLA CERIFERA POLLEN 1000 [PNU]/mL "Non-Sta
ALLERGENIC BETULA LENTA POLLEN Black Birch "INJECTION, SOLU
ALLERGENIC BETULA NIGRA POLLEN River Birch Red "INJECTION, SOLU
ALLERGENIC BETULA LENTA POLLEN White Birch "INJECTION, SOLU
ALLERGENIC POA ANNUA POLLEN Annual Bluegrass "INJECTI
llo, Inc." BROMUS INERMIS POLLEN 1000 [PNU]/mL "Non-Standardize
"ALK-Abello, Inc." AMARANTHUS PALMERI POLLEN 1000 [PNU]/mL
Ingredient]"
ALLERGENIC JUNIPERUS ASHEI POLLEN Mountain Cedar "INJECTION, SOLU
llo, Inc." JUNIPERUS ASHEI POLLEN 1000 [PNU]/mL "Non-Standardize
ALLERGENIC JUNIPERUS VIRGINIANA POLLEN Red Cedar "INJECTI
"ALK-Abello, Inc." JUNIPERUS VIRGINIANA POLLEN 1000 [PNU]/mL
r "INJECTION, SOLUTION" INTRADERMAL 19650101 BLA
]"
ALLERGENIC POPULUS DELTOIDES POLLEN Eastern Cottonwood Commo
n "INJECTION, SOLUTION" INTRADERMAL 19650101 BLA
ALLERGENIC POPULUS FREMONTII POLLEN Fremont Cottonwood
ALLERGENIC POPULUS DELTOIDES SSP MONILIFERA POLLEN Western Cottonwo
od "INJECTION, SOLUTION" PERCUTANEOUS 19650101 BLA
ALLERGENIC POPULUS DELTOIDES SSP MONILIFERA POLLEN Western Cottonwo
od "INJECTION, SOLUTION" INTRADERMAL 19650101 BLA
EN 1000 [PNU]/mL "Non-Standardized Pollen Allergenic Extract [EPC
ALLERGENIC CUPRESSUS ARIZONICA POLLEN Arizona Cypress "INJECTI
"ALK-Abello, Inc." CUPRESSUS ARIZONICA POLLEN 1000 [PNU]/mL
ALLERGENIC RUMEX ACETOSELLA POLLEN Sour Dock Sheep Sorrel "INJECTI
ALLERGENIC RUMEX CRISPUS POLLEN Yellow Dock "INJECTION, SOLU
llo, Inc." RUMEX CRISPUS POLLEN 1000 [PNU]/mL "Non-Standardize
"ALK-Abello, Inc." EUPATORIUM CAPILLIFOLIUM POLLEN 0.05 g/mL "Non-Sta
"ALK-Abello, Inc." EUPATORIUM CAPILLIFOLIUM POLLEN 1000 [PNU]/mL
ALLERGENIC ULMUS AMERICANA POLLEN American Elm "INJECTION, SOLU
ALLERGENIC ULMUS CRASSIFOLIA POLLEN Cedar Elm "INJECTI
ALLERGENIC ULMUS PUMILA POLLEN Chinese Elm "INJECTION, SOLU
mical/Ingredient]"
ALLERGENIC ULMUS PUMILA POLLEN Chinese Elm "INJECTION, SOLU
llo, Inc." ULMUS PUMILA POLLEN 1000 [PNU]/mL "Non-Standardize
ALLERGENIC CARYA OVATA POLLEN Shagbark Hickory "INJECTI
"ALK-Abello, Inc." CARYA OVATA POLLEN 1000 [PNU]/mL "Non-Sta
ALLERGENIC JUNIPERUS CALIFORNICA POLLEN Western Juniper "INJECTI
"ALK-Abello, Inc." JUNIPERUS CALIFORNICA POLLEN 1000 [PNU]/mL
ALLERGENIC ROBINIA PSEUDOACACIA POLLEN Black Locust "INJECTI
"ALK-Abello, Inc." ROBINIA PSEUDOACACIA POLLEN 0.05 g/mL "Non-Sta
ALLERGENIC ROBINIA PSEUDOACACIA POLLEN Black Locust "INJECTI
"ALK-Abello, Inc." ROBINIA PSEUDOACACIA POLLEN 1000 [PNU]/mL
ALLERGENIC ACER RUBRUM POLLEN Red Maple "INJECTION, SOLU
llo, Inc." ACER RUBRUM POLLEN 1000 [PNU]/mL "Non-Standardize
ALLERGENIC ACER SACCHARUM POLLEN Sugar Maple "INJECTION, SOLU
ALLERGENIC IVA XANTHIFOLIA POLLEN Burweed Marshelder "INJECTI
"ALK-Abello, Inc." IVA XANTHIFOLIA POLLEN 1000 [PNU]/mL "Non-Sta
ALLERGENIC IVA ANNUA VAR ANNUA POLLEN Rough Marshelder
"ALK-Abello, Inc." PROSOPIS JULIFLORA POLLEN 1000 [PNU]/mL
ALLERGENIC ARTEMISIA VULGARIS POLLEN Common Mugwort "INJECTI
Ingredient]"
ALLERGENIC MORUS RUBRA POLLEN Red Mulberry "INJECTION, SOLU
llo, Inc." MORUS RUBRA POLLEN 1000 [PNU]/mL "Non-Standardize
ALLERGENIC MORUS ALBA POLLEN White Mulberry "INJECTION, SOLU
llo, Inc." MORUS ALBA POLLEN 1000 [PNU]/mL "Non-Standardize
ALLERGENIC QUERCUS AGRIFOLIA POLLEN California Live Oak Coas
t "INJECTION, SOLUTION" PERCUTANEOUS 19650101 BLA
ALLERGENIC QUERCUS AGRIFOLIA POLLEN California Live Oak Coas
t "INJECTION, SOLUTION" INTRADERMAL 19650101 BLA
BLA103753 "ALK-Abello, Inc." QUERCUS AGRIFOLIA POLLEN 1000
ALLERGENIC QUERCUS RUBRA POLLEN Red Oak "INJECTION, SOLUTION"
." QUERCUS RUBRA POLLEN 1000 [PNU]/mL "Non-Standardized Pollen
mical/Ingredient]"
ALLERGENIC QUERCUS VIRGINIANA POLLEN Virginia Live Oak
3 "ALK-Abello, Inc." QUERCUS VIRGINIANA POLLEN 1000 [PNU]/mL
ALLERGENIC QUERCUS ALBA POLLEN White Oak "INJECTION, SOLU
ALLERGENIC QUERCUS ALBA POLLEN Wild Pollen Oat "INJECTION, SOLU
mical/Ingredient]"
ALLERGENIC SCHINUS MOLLE POLLEN California Pepper Tree "INJECTI
"ALK-Abello, Inc." SCHINUS MOLLE POLLEN 0.05 g/mL "Non-Standardize
ALLERGENIC AMARANTHUS SPINOSUS POLLEN Spiny Pigweed "INJECTI
nt]"
ALLERGENIC CASUARINA EQUISETIFOLIA POLLEN Australian Pine Beefwood
ALLERGENIC PINUS ECHINATA POLLEN Yellow Pine "INJECTION, SOLU
mical/Ingredient]"
ALLERGENIC AMBROSIA ACANTHICARPA POLLEN False Ragweed Bur
Ingredient]"
ALLERGENIC AMBROSIA TENUIFOLIA POLLEN Slender Ragweed "INJECTI
nt]"
ALLERGENIC AMBROSIA BIDENTATA POLLEN Southern Ragweed
Ingredient]"
ALLERGENIC AMBROSIA PSILOSTACHYA POLLEN Western Ragweed "INJECTI
nt]"
ALLERGENIC LOLIUM PERENNE SSP MULTIFLORUM POLLEN Italian Rye Gras
s "INJECTION, SOLUTION" PERCUTANEOUS 19650101 BLA
BLA103753 "ALK-Abello, Inc." LOLIUM PERENNE SSP. MULTIFLORUM POLLEN
ALLERGENIC ARTEMISIA FRIGIDA POLLEN Prairie Sage "INJECTI
nt]"
ALLERGENIC JUGLANS NIGRA POLLEN California Walnut Black Pollen
3 "ALK-Abello, Inc." JUGLANS NIGRA POLLEN 0.05 g/mL "Non-Sta
ALLERGENIC JUGLANS REGIA POLLEN English Walnut Pollen "INJECTI
ALLERGENIC ARTEMISIA ANNUA POLLEN Common Wormwood Annual "INJECTI
"ALK-Abello, Inc." ARTEMISIA ANNUA POLLEN 0.05 g/mL "Non-Standardize
ALLERGENIC BETULA LENTA POLLEN White Pine "INJECTION, SOLU
mical/Ingredient]"
llo, Inc." OLEA EUROPAEA POLLEN 1000 [PNU]/mL "Non-Standardize
ALLERGENIC SYAGRUS ROMANZOFFIANA POLLEN Queen Palm Coco Palm
3 "ALK-Abello, Inc." SYAGRUS ROMANZOFFIANA POLLEN 1000 [PNU]/mL
ALLERGENIC AMARANTHUS RETROFLEXUS POLLEN Rough Pigweed Redroot
Ingredient]"
ALLERGENIC CASUARINA EQUISETIFOLIA POLLEN Australian Pine Beefwood
ALLERGENIC PLANTAGO LANCEOLATA POLLEN English Plantain
ALLERGENIC POPULUS ALBA POLLEN White Poplar "INJECTION, SOLU
llo, Inc." POPULUS ALBA POLLEN 1000 [PNU]/mL "Non-Standardize
llo, Inc." LIGUSTRUM VULGARE POLLEN 1000 [PNU]/mL "Non-Sta
ALLERGENIC AMBROSIA ACANTHICARPA POLLEN False Ragweed Bur
3 "ALK-Abello, Inc." AMBROSIA ACANTHICARPA POLLEN 1000 [PNU]/mL
Ingredient]"
ALLERGENIC AMBROSIA TRIFIDA POLLEN Tall Ragweed Giant "INJECTI
nt]"
ALLERGENIC AMBROSIA PSILOSTACHYA POLLEN Western Ragweed "INJECTI
"ALK-Abello, Inc." AMBROSIA PSILOSTACHYA POLLEN 1000 [PNU]/mL
Ingredient]"
ALLERGENIC ARTEMISIA FRIGIDA POLLEN Prairie Sage "INJECTI
"ALK-Abello, Inc." ARTEMISIA FRIGIDA POLLEN 1000 [PNU]/mL
Ingredient]"
ALLERGENIC ARTEMISIA TRIDENTATA POLLEN Common Sagebrush
3 "ALK-Abello, Inc." ARTEMISIA TRIDENTATA POLLEN 1000 [PNU]/mL
Ingredient]"
ALLERGENIC LIQUIDAMBAR STYRACIFLUA POLLEN Sweetgum Non Stock
3 "ALK-Abello, Inc." LIQUIDAMBAR STYRACIFLUA POLLEN 1000 [PNU]/mL
ALLERGENIC PLATANUS OCCIDENTALIS POLLEN American Sycamore
llo, Inc." HOLCUS LANATUS POLLEN 1000 [PNU]/mL "Non-Standardize
"ALK-Abello, Inc." JUGLANS NIGRA POLLEN 1000 [PNU]/mL "Non-Sta
ALLERGENIC JUGLANS NIGRA POLLEN California Walnut Black Pollen
3 "ALK-Abello, Inc." JUGLANS NIGRA POLLEN 1000 [PNU]/mL
ALLERGENIC JUGLANS REGIA POLLEN English Walnut Pollen "INJECTI
"ALK-Abello, Inc." JUGLANS REGIA POLLEN 1000 [PNU]/mL "Non-Sta
"ALK-Abello, Inc." TRITICUM AESTIVUM POLLEN 1000 [PNU]/mL
gredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Ext
ract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increase
d IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredien
t]"
ALLERGENIC SALIX NIGRA POLLEN Black Willow "INJECTION, SOLU
"ALK-Abello, Inc." DERMATOPHAGOIDES FARINAE 10000 [AU]/mL "Standar
dized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-medi
ated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Che
mical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingr
edient]"
ronyssinus SOLUTION PERCUTANEOUS 19900814 BLA
BLA103752 "ALK-Abello, Inc." DERMATOPHAGOIDES PTERONYSSINUS 10000
[AU]/mL "Standardized Insect Allergenic Extract [EPC],Increased Histamine Releas
e [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Derma
tophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergen
65757-300_0f451803-1f98-4fa3-b71f-2bb6f9c5624a 65757-300 HUMAN PRESCRIPTI
ON DRUG VIVITROL naltrexone KIT 20060613
NDA NDA021897 "Alkermes, Inc."
65757-301_a74b26b1-e75c-4aea-a7e1-c5091c2771ba 65757-301 HUMAN PRESCRIPTI
ON DRUG VIVITROL naltrexone KIT 20060613
NDA NDA021897 "Alkermes, Inc."
68685-0001_6ceddeb1-5ab7-4cef-a2eb-aec70b897c5f 68685-0001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS "All American Medical Equipment, Inc." OXYGEN
99 L/100L
63139-001_fdf0f8c7-dcf0-4055-85e4-9d58769bba92 63139-001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS All American Welding Supply Inc OXYGEN 990
mL/L
51769-002_f417a71f-7351-40f1-ac5a-05536bb745ba 51769-002 HUMAN OTC DRUG
TING Athetes foot "Undecylenic acid, Triclosan" CREAM CUTANEOUS
20130109 OTC MONOGRAPH FINAL part333C ALL NATURAL DYNA
MICS TRICLOSAN; UNDECYLENIC ACID .1; 3.78 g/100g; g/100g
51769-003_050c22b8-dc2f-414c-a4ad-13468bd28728 51769-003 HUMAN OTC DRUG
TING Cream "Undecylenic acid, Triclosan" CREAM CUTANEOUS 20130315
OTC MONOGRAPH FINAL part333C ALL NATURAL DYNAMICS TRICLOSAN; UNDEC
YLENIC ACID .1; 3.78 g/100g; g/100g
51769-105_ed663d70-2279-4e16-98fe-152c6da4e253 51769-105 HUMAN OTC DRUG
OBAO Soft Freshness ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20130902
OTC MONOGRAPH FINAL part350 ALL NATURAL DYNAMICS ALUMINUM CHLOROHYDRATE
15 g/100g
51769-107_c94e1ee6-fe8a-415f-b13f-b4fe91258e54 51769-107 HUMAN OTC DRUG
Obao Bamboo Breeze Aluminum Chlorohydrate STICK TOPICAL 20130301
15 g/100g
51769-123_48767cdd-c72a-45a0-a69e-c89a3a1c3213 51769-123 HUMAN OTC DRUG
Obao Floral Freshness ALUMINUM CHLOROHYDRATE STICK TOPICAL 20130312
15 g/100g
51769-124_f4b42768-3a6d-464a-92b5-94d7a57a2e06 51769-124 HUMAN OTC DRUG
antiperspirant deodorant ALUMINUM CHLOROHYDRATE LIQUID TOPICAL
20100331 OTC MONOGRAPH FINAL part350 ALL NATURAL DYNAMICS
ALUMINUM CHLOROHYDRATE 15 g/100g
51769-125_eda0e98f-2879-4334-8c9b-fb338e4a4fdb 51769-125 HUMAN OTC DRUG
Obao Cool Metal Aluminum Chlorohydrate STICK TOPICAL 20130301
15 g/100g
51769-127_572e8cfb-376f-4588-afbf-0a3cbcc694a5 51769-127 HUMAN OTC DRUG
Obao Active ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20100331
15 g/100g
51769-133_6c83ea07-49b7-4448-ba47-bc80062868f6 51769-133 HUMAN OTC DRUG
Head and Shoulders menthol fresh Pyrithione Zinc LOTION/SHAMPOO TOPICAL
20130124 OTC MONOGRAPH FINAL part358H ALL NATURAL DYNA
MICS PYRITHIONE ZINC 0.01 g/mL
51769-134_8a5d9da2-91e2-4b94-8bfa-384ef298217e 51769-134 HUMAN OTC DRUG
Head and Shoulders menthol fresh Pyrithione Zinc LOTION/SHAMPOO TOPICAL
51769-139_bee61e39-5dbe-4dc0-b6bd-d753fe128346 51769-139 HUMAN OTC DRUG
Head and Shoulders renewing clean Pyrithione Zinc LOTION/SHAMPOO TOPICAL
51769-140_e99160c9-87f4-4ca9-9765-0cef60308776 51769-140 HUMAN OTC DRUG
Head and Shoulders hair loss prevention Pyrithione Zinc SHAMPOO TOPICAL
51769-141_f58016ec-c5ab-4943-bd2b-e85b04fac313 51769-141 HUMAN OTC DRUG
Head and Shoulders breakage prevention Pyrithione Zinc SHAMPOO TOPICAL
51769-411_8b520486-b7e9-4074-b666-5e5614068bf8 51769-411 HUMAN OTC DRUG
Obao Sensitive Passion Aluminum Chlorohydrate STICK TOPICAL 20130301
15 g/100g
51769-412_e341a078-48af-41ea-9997-869f72bdaebb 51769-412 HUMAN OTC DRUG
Obao Sensitive Passion Aluminum Chlorohydrate STICK TOPICAL 20130301
15 g/100g
51769-555_4b816b38-e0dc-4ef5-ae2d-837ab9173a8e 51769-555 HUMAN OTC DRUG
MUM CHAMOMILE Aluminum Chlorohydrate STICK TOPICAL 20130301
15 g/100g
51769-614_a01e67cc-29df-415d-b742-a6ca74b63604 51769-614 HUMAN OTC DRUG
Clarant B3 Avobenzone Octinoxate CREAM TOPICAL 20140704
OTC MONOGRAPH NOT FINAL part352 ALL NATURAL DYNAMICS AVOBENZONE; OCTINOXATE
2800; 7100 mg/100g; mg/100g
51769-615_22a06b2d-dda0-49ed-b729-b22715f8ff17 51769-615 HUMAN OTC DRUG
PONDS clarant b3 Anti-Dark Moisturizing Cream CREAM TOPICAL 20120629
OTC MONOGRAPH FINAL part352 ALL NATURAL DYNAMICS AVOBENZONE 3
g/100g
51769-666_4311bbeb-fece-4b8e-80a9-292e0a91befc 51769-666 HUMAN OTC DRUG
Lady Speed Stick Aluminum Chlorohydrate STICK TOPICAL 20130301
15 g/100g
51769-888_ffb56df0-1f94-4f1f-8703-ffd2cc905587 51769-888 HUMAN OTC DRUG
Obao Men Audaz Aluminum Chlorohydrate LIQUID TOPICAL 20130823
15 g/100g
51769-890_0e7fbffb-5081-4335-8d84-e3c9b03f1742 51769-890 HUMAN OTC DRUG
PONDS VAO-B3 AVOBENZONE CREAM TOPICAL 20130902 OTC MONO
GRAPH FINAL part352 ALL NATURAL DYNAMICS AVOBENZONE 3 g/100g
51769-901_9f63604f-8dae-449c-87eb-a2ba10617f14 51769-901 HUMAN OTC DRUG
Head and Shoulders smooth and silky Pyrithione Zinc LOTION/SHAMPOO
TOPICAL 20130124 OTC MONOGRAPH FINAL part358H ALL NATU
RAL DYNAMICS PYRITHIONE ZINC 0.01 g/mL
51769-980_61d9c594-134a-4112-a985-09d075498cf0 51769-980 HUMAN OTC DRUG
STEFANO Fire ALUMINUM CHLOROHYDRATE STICK TOPICAL 20120517
25 g/100mL
54202-001_a891d816-59d5-4f65-8314-c7c4ce8b5ec6 54202-001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS All Saints Home Medical OXYGEN 99 L/100L
28595-300_be486bc9-6a4f-4c41-8ca9-a2899edbd743 28595-300 HUMAN OTC DRUG
Brohist D Brompheniramine Maleate and Phenylephrine Hydrochloride
part341 "Allegis Pharmaceuticals, LLC" BROMPHENIRAMINE MALEATE; PHENYLEPHRINE H
28595-420_6da77968-9e74-4798-8a87-6d4f4a87b817 28595-420 HUMAN PRESCRIPTI
ON DRUG Otozin "Antipyrine, Benzocaine, and Zinc Acetate" SOLUTION
TOPICAL 20110506 UNAPPROVED DRUG OTHER "Allegis Pharmac
euticals, LLC" ANTIPYRINE; BENZOCAINE; ZINC ACETATE 54; 10; 10 mg/mL; m
g/mL; mg/mL "Standardized Chemical Allergen [EPC],Increased Histamine Releas
28595-500_2b616305-bbc8-4e8c-83d8-4a0045f323d4 28595-500 HUMAN PRESCRIPTI
ON DRUG DermaNIC "NIACINAMIDE, INOSITOL NIACINATE, NIACIN, CHROMI
UM NICOTINATE, FOLIC ACID, HYDROXOCOBALAMIN, FERROUS CYSTEINE GLYCINATE, and ACE
TYLCYSTEINE ZINC" TABLET ORAL 20140203 UNAPPROVED DRUG
OTHER "Allegis Pharmaceuticals, LLC" ACETYLCYSTEINE ZINC; CHROMIUM NI
COTINATE; FERROUS CYSTEINE GLYCINATE; FOLIC ACID; HYDROXOCOBALAMIN; INOSITOL NIA
CINATE; NIACIN; NIACINAMIDE 69.5; .57; 1.5; 500; 15; 328; 1.5; 498 mg/1; mg
/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1 "Nicotinic Acid [EPC],Nicotinic Acids [C
hemical/Ingredient],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],N
icotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Antidote [EPC],Copper
Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE]"
28595-570_9a1036fd-3e9e-49e8-900b-6f1b933ba527 28595-570 HUMAN PRESCRIPTI
ON DRUG Spinosad spinosad SUSPENSION TOPICAL 20140625
NDA NDA022408 "Allegis Pharmaceuticals, LLC" SPINOSAD 9
mg/mL Pediculicide [EPC]
28595-780_52cf1494-9ab8-4ed1-9061-5d192c204846 28595-780 HUMAN OTC DRUG
HistaFlex ACETAMINOPHEN and PYRILAMINE MALEATE TABLET ORAL
20140522 OTC MONOGRAPH NOT FINAL part343 "Allegis Pharmaceuticals
, LLC" ACETAMINOPHEN; PYRILAMINE MALEATE 325; 25 mg/1; mg/1
28595-800_aa07b430-abc9-492f-818b-9fa94c5f7490 28595-800 HUMAN OTC DRUG
AP-Hist DM "Brompheniramine Maleate, Phenylephrine Hydrochloride, a
nd Dextromethorphan Hydrobromide" LIQUID ORAL 20130415
OTC MONOGRAPH FINAL part341 "Allegis Pharmaceuticals, LLC" BROMPHENIRAMINE
MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 4; 15; 7
.5 mg/mL; mg/mL; mg/mL
28595-801_41079447-f4b9-4da6-8ed2-f6810eb2346f 28595-801 HUMAN OTC DRUG
HISTEX PD Drops TRIPROLIDINE HYDROCHLORIDE SYRUP ORAL 20140306
OTC MONOGRAPH FINAL part341 "Allegis Pharmaceuticals, LLC" TRIPROLIDINE HYD
ROCHLORIDE 0.938 mg/mL
28595-802_d54fba80-fcd0-4fc5-9870-1e3e6e7b51ea 28595-802 HUMAN OTC DRUG
HISTEX TRIPROLIDINE HYDROCHLORIDE SYRUP ORAL 20140304
OTC MONOGRAPH FINAL part341 "Allegis Pharmaceuticals, LLC" TRIPROLIDINE HYD
ROCHLORIDE 2.5 mg/5mL
28595-803_660edee9-4a95-4a0b-b951-c5283293c626 28595-803 HUMAN OTC DRUG
HISTEX-PE PHENYLEPHRINE HYDROCHLORIDE and TRIPROLIDINE HYDROCHLORI
DE SYRUP ORAL 20140317 OTC MONOGRAPH FINAL part341
"Allegis Pharmaceuticals, LLC" PHENYLEPHRINE HYDROCHLORIDE; TRIPROLIDINE HYDROC
HLORIDE 10; 2.5 mg/5mL; mg/5mL
28595-804_ac2157ef-390a-4c6d-a304-9e78aae1294d 28595-804 HUMAN OTC DRUG
HISTEX-DM "DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLOR
IDE, and TRIPROLIDINE HYDROCHLORIDE" SYRUP ORAL 20140319
OTC MONOGRAPH FINAL part341 "Allegis Pharmaceuticals, LLC" DEXTROMETHORPHAN
HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE 20; 10;
2.5 mg/5mL; mg/5mL; mg/5mL
28595-900_7dcb52dc-f40f-4c24-b866-5d18ef4f3e2c 28595-900 HUMAN OTC DRUG
Ru-Hist D Brompheniramine Maleate and Phenylephrine Hydrochloride
part341 "Allegis Pharmaceuticals, LLC" BROMPHENIRAMINE MALEATE; PHENYLEPHRINE H
28595-905_a8aa7148-a219-4c68-895c-b3753d730526 28595-905 HUMAN OTC DRUG
Duravent PE GUAIFENESIN and PHENYLEPHRINE HYDROCHLORIDE TABLET
ORAL 20140227 OTC MONOGRAPH FINAL part341 "Allegis Pharmac
euticals, LLC" GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 395; 10 mg/1; mg
/1
28595-906_505ea130-06ab-47a3-8dde-60987f5089b6 28595-906 HUMAN OTC DRUG
Duravent DM "DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLE
PHRINE HYDROCHLORIDE" TABLET ORAL 20140227 OTC MONOGRAPH FI
NAL part341 "Allegis Pharmaceuticals, LLC" DEXTROMETHORPHAN HYDROBROMIDE; G
UAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 15; 395; 10 mg/1; mg/1; mg/1
60881-555_eb790611-1402-415e-9062-dff11826dbdd 60881-555 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS "Allen Medical, Inc" OXYGEN 99 L/100L
49790-001_74d8d839-3cf1-4fbf-bc2b-4999f577c7f4 49790-001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS Allen's Cylinder Testing & Inspection Company
OXYGEN 992 mL/L
0023-0042_07a5c024-17aa-4198-87a7-8db5d0dfcd54 0023-0042 HUMAN PRESCRIPTI
ON DRUG TAZORAC tazarotene GEL CUTANEOUS 19970801
NDA NDA020600 "Allergan, Inc." TAZAROTENE 1 mg/g
"Retinoid [EPC],Retinoids [Chemical/Ingredient]"
0023-0066_b92c96dd-1869-4fa7-8ac9-7d417e1f3a9e 0023-0066 HUMAN PRESCRIPTI
ON DRUG PRED-G gentamicin sulfate and prednisolone acetate OINTMENT
OPHTHALMIC 19900101 NDA NDA050612 "Allergan, Inc."
GENTAMICIN SULFATE; PREDNISOLONE ACETATE 3; 6 mg/g; mg/g "Aminogl
0023-0106_e6bd006e-c092-43d0-a9a1-f9bc9596a50b 0023-0106 HUMAN PRESCRIPTI
ON DRUG PRED-G "gentamicin, prednisolone acetate" SUSPENSION/ DROP
S OPHTHALMIC 19900219 NDA NDA050586 "Allerga
n, Inc." GENTAMICIN; PREDNISOLONE ACETATE 3; 10 mg/mL; mg/mL
"Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Cortic
osteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]"
0023-0240_748e5be4-4838-4625-b697-0752ffe4f41f 0023-0240 HUMAN OTC DRUG
REFRESH P.M. "mineral oil, petrolatum" OINTMENT OPHTHALM
IC 19900423 OTC MONOGRAPH FINAL part349 "Allergan, Inc."
MINERAL OIL; PETROLATUM 425; 573 mg/g; mg/g
0023-0312_33707096-4210-49e2-953d-23c5c0c1cf48 0023-0312 HUMAN OTC DRUG
REFRESH LACRI-LUBE "mineral oil, petrolatum" OINTMENT
OPHTHALMIC 19771215 OTC MONOGRAPH FINAL part349 "Allerga
n, Inc." MINERAL OIL; PETROLATUM 425; 568 mg/g; mg/g
0023-0313_b7b076a9-d41c-438c-8e03-4a0d94605419 0023-0313 HUMAN PRESCRIPTI
ON DRUG BLEPHAMIDE sulfacetamide sodium and prednisolone acetate
"Allergan, Inc." PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM 2; 100
mg/g; mg/g "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [
MoA],Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient]"
0023-0316_9c77b0ad-2660-4ef1-bd0c-c98c80310633 0023-0316 HUMAN PRESCRIPTI
ON DRUG FML fluorometholone OINTMENT OPHTHALMIC 19851209
NDA NDA017760 "Allergan, Inc." FLUOROMETHOLONE 1 mg/g
0023-0403_89058078-d6c4-4a7e-9559-a40fc7cb4ba8 0023-0403 HUMAN OTC DRUG
REFRESH PLUS carboxymethylcellulose sodium SOLUTION/ DROPS OPHTHALM
CARBOXYMETHYLCELLULOSE SODIUM 5 mg/mL
0023-0506_29f3768b-45bc-4ef0-9987-9b3068cf3c86 0023-0506 HUMAN OTC DRUG
REFRESH Classic "Polyvinyl Alcohol, Povidone" SOLUTION/ DROPS OPHTHALM
POLYVINYL ALCOHOL; POVIDONE 14; 6 mg/mL; mg/mL
0023-0798_10553be3-92e1-4051-b5f1-229bb6493d98 0023-0798 HUMAN OTC DRUG
REFRESH TEARS carboxymethylcellulose sodium SOLUTION/ DROPS OPHTHALM
0023-1134_707cd909-5443-42c3-b56e-84513c3dc0e4 0023-1134 HUMAN OTC DRUG
M.D. FORTE Aftercare Environmental Protection Sunscreen SPF 30 "octinox
ate, octisalate, zinc oxide" CREAM TOPICAL 19980324 OTC MONO
GRAPH NOT FINAL part352 "Allergan, Inc." OCTINOXATE; OCTISALATE; ZINC OXI
DE 75; 40; 78 mg/g; mg/g; mg/g
0023-1145_a1d4db54-f02d-491f-be91-15e2f5f2876b 0023-1145 HUMAN PRESCRIPTI
ON DRUG BOTOX onabotulinumtoxinA "INJECTION, POWDER, LYOPHILIZED,
FOR SOLUTION" INTRADERMAL; INTRAMUSCULAR 19891215 BLA
BLA103000 "Allergan, Inc." BOTULINUM TOXIN TYPE A 100 [USP'U]/
1 "Acetylcholine Release Inhibitor [EPC],Acetylcholine Release Inhibitors
[MoA]"
0023-2181_c3d6f9f9-77f8-4f00-a435-59320ec5e6c8 0023-2181 HUMAN PRESCRIPTI
ON DRUG Acular Ketorolac Tromethamine SOLUTION/ DROPS OPHTHALMIC
19921201 NDA NDA019700 "Allergan, Inc." KETOROLA
C TROMETHAMINE 5 mg/mL "Cyclooxygenase Inhibitors [MoA],Nonsteroidal An
rug [EPC]"
0023-3205_6b6336d4-f4a9-40f2-ab0b-6df5a7af93f9 0023-3205 HUMAN PRESCRIPTI
ON DRUG LUMIGAN bimatoprost SOLUTION/ DROPS OPHTHALMIC 20100910
NDA NDA022184 "Allergan, Inc." BIMATOPROST 0.1 mg/mL
"Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient]"
0023-3240_2358c98f-9740-4da7-ba6d-201984584521 0023-3240 HUMAN OTC DRUG
REFRESH OPTIVE carboxymethylcellulose sodium and glycerin SOLUTION
"Allergan, Inc." CARBOXYMETHYLCELLULOSE SODIUM; GLYCERIN 5; 9 mg/mL; m
g/mL
0023-3348_a34c5fd6-1e17-486a-adf5-be3374f232e0 0023-3348 HUMAN PRESCRIPTI
ON DRUG OZURDEX dexamethasone IMPLANT INTRAVITREAL 20090901
NDA NDA022315 "Allergan, Inc." DEXAMETHASONE 0.7 mg/1
0023-3416_18fb4f49-3480-42a9-89ce-b47dcc6f585b 0023-3416 HUMAN OTC DRUG
Refresh Optive "Carboxymethylcellulose Sodium, Glycerin" SOLUTION
"Allergan, Inc." CARBOXYMETHYLCELLULOSE SODIUM; GLYCERIN 5; 9 mg/mL; m
g/mL
0023-3459_9bf01981-aae8-4c1b-8c6e-e6fa157891bf 0023-3459 HUMAN OTC DRUG
VIVITE Daily Facial Moisturizer with Sunscreen SPF 30 "octinoxate, oct
isalate, oxybenzone" LOTION TOPICAL 20080519 OTC MONOGRAPH NO
T FINAL part352 "Allergan, Inc." OCTINOXATE; OCTISALATE; OXYBENZONE
0023-3507_c3398c36-2428-4631-acaf-becfffdcd855 0023-3507 HUMAN PRESCRIPTI
ON DRUG ACUVAIL ketorolac tromethamine SOLUTION/ DROPS OPHTHALMIC
20090801 NDA NDA022427 "Allergan, Inc." KETOROLA
C TROMETHAMINE 4.5 mg/mL "Cyclooxygenase Inhibitors [MoA],Nonsteroidal An
rug [EPC]"
0023-3513_b5827e15-d555-4f45-bbf5-45648cb9bc2a 0023-3513 HUMAN PRESCRIPTI
ON DRUG SANCTURA trospium chloride TABLET ORAL 20071201
20150919 NDA NDA021595 "Allergan, Inc." TROSPIUM CHLORID
E 20 mg/1 "Cholinergic Muscarinic Antagonist [EPC],Cholinergic Mus
carinic Antagonists [MoA]"
0023-3615_d4c11f0d-8bd2-4abb-b258-3b86dcbe3ec9 0023-3615 HUMAN PRESCRIPTI
ON DRUG ZYMAXID gatifloxacin SOLUTION/ DROPS OPHTHALMIC 20100519
NDA NDA022548 "Allergan, Inc." GATIFLOXACIN 5 mg/mL
"Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]"
0023-3616_f568045e-7af3-42e0-8aa6-652a0dc9a088 0023-3616 HUMAN PRESCRIPTI
ON DRUG LATISSE bimatoprost SOLUTION/ DROPS OPHTHALMIC 20090126
NDA NDA022369 "Allergan, Inc." BIMATOPROST 0.3 mg/mL
"Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient]"
0023-3670_76d49ab9-6426-4d7e-8f72-fb6f8ad780e2 0023-3670 HUMAN PRESCRIPTI
ON DRUG ACZONE dapsone GEL TOPICAL 20090624 NDA
NDA021794 "Allergan, Inc." DAPSONE 50 mg/g "Sulfone [EPC],S
ulfones [Chemical/Ingredient]"
0023-3919_b35cb2f6-813a-4693-8a83-2879fe17d510 0023-3919 HUMAN PRESCRIPTI
ON DRUG BOTOX Cosmetic onabotulinumtoxinA "INJECTION, POWDER, LYOP
HILIZED, FOR SOLUTION" INTRAMUSCULAR 20080520 BLA BLA10300
0 "Allergan, Inc." BOTULINUM TOXIN TYPE A 50 [USP'U]/1
"Acetylcholine Release Inhibitor [EPC],Acetylcholine Release Inhibitors [MoA]"
0023-3921_a1d4db54-f02d-491f-be91-15e2f5f2876b 0023-3921 HUMAN PRESCRIPTI
ON DRUG BOTOX onabotulinumtoxinA "INJECTION, POWDER, LYOPHILIZED,
FOR SOLUTION" INTRADERMAL; INTRAMUSCULAR 20100111 BLA
BLA103000 "Allergan, Inc." BOTULINUM TOXIN TYPE A 200 [USP'U]/
1 "Acetylcholine Release Inhibitor [EPC],Acetylcholine Release Inhibitors
[MoA]"
0023-4290_8e3c57ed-f4dc-4850-9397-190bee4708a0 0023-4290 HUMAN PRESCRIPTI
ON DRUG LASTACAFT alcaftadine SOLUTION/ DROPS OPHTHALMIC
20101101 NDA NDA022134 "Allergan, Inc." ALCAFTAD
INE 2.5 mg/mL
0023-4307_f58bb64b-6a8e-4769-9789-df89df449cb2 0023-4307 HUMAN OTC DRUG
REFRESH OPTIVE Advanced "carboxymethylcellulose sodium, glycerin, and po
lysorbate 80" SOLUTION/ DROPS OPHTHALMIC 20111130 OTC MONO
GRAPH FINAL part349 "Allergan, Inc." CARBOXYMETHYLCELLULOSE SODIUM; G
LYCERIN; POLYSORBATE 80 5; 10; 5 mg/mL; mg/mL; mg/mL
0023-4383_3188e44c-410f-4847-aaf0-2ae503db7d58 0023-4383 HUMAN OTC DRUG
VIVITE Aftercare Environmental Protection Sunscreen SPF 30 "octinox
ate, octisalate, zinc oxide" CREAM TOPICAL 20111015 OTC MONO
GRAPH NOT FINAL part352 "Allergan, Inc." OCTINOXATE; OCTISALATE; ZINC OXI
DE 75; 40; 78 mg/g; mg/g; mg/g
0023-4385_fcd68e21-f2a9-4de5-bc51-668a7c3c11b9 0023-4385 HUMAN PRESCRIPTI
ON DRUG BETAGAN levobunolol hydrochloride SOLUTION/ DROPS OPHTHALM
IC 19860724 NDA NDA019219 "Allergan, Inc."
LEVOBUNOLOL HYDROCHLORIDE 5 mg/mL "Adrenergic beta-Antagonists [Mo
0023-4491_ecfbf5e7-9b65-43f4-983e-b278a481f13c 0023-4491 HUMAN OTC DRUG
REFRESH OPTIVE Advanced "carboxymethylcellulose sodium, glycerin, polyso
rbate 80" SOLUTION/ DROPS OPHTHALMIC 20130115 OTC MONO
GRAPH FINAL part349 "Allergan, Inc." CARBOXYMETHYLCELLULOSE SODIUM; G
LYCERIN; POLYSORBATE 80 5; 10; 5 mg/mL; mg/mL; mg/mL
0023-4554_e7f9d92e-898b-494b-94fe-7516c0a92a5a 0023-4554 HUMAN OTC DRUG
REFRESH CELLUVISC carboxymethylcellulose sodium GEL OPHTHALM
0023-4857_0cabbfd5-ec30-44a9-9f64-2532fa0cfe07 0023-4857 HUMAN PRESCRIPTI
ON DRUG VANIQA eflornithine hydrochloride CREAM TOPICAL 20130601
NDA NDA021145 "Allergan, Inc." EFLORNITHINE HYDROCHLORIDE
139 mg/g "Antiprotozoal [EPC],Decarboxylase Inhibitor [EPC],Decarboxylase
Inhibitors [MoA]"
0023-4948_b1d568c7-6251-4d63-8bb5-de5a7b450b63 0023-4948 HUMAN OTC DRUG
SKIN MEDICA Purifying Foaming Wash salicylic acid LIQUID TOPICAL
20130101 OTC MONOGRAPH FINAL part333D "Allergan, Inc."
SALICYLIC ACID 20 mg/mL
0023-4951_4a06acb8-2861-4553-a411-53c2c297fd59 0023-4951 HUMAN OTC DRUG
SkinMedica Purifying Toner Salicylic Acid LIQUID TOPICAL 20130101
20151031 OTC MONOGRAPH FINAL part333D "Allergan, Inc."
0023-4953_76d3e6b9-77a9-40c2-84c9-3bcc173be9b4 0023-4953 HUMAN OTC DRUG
SkinMedica TNS Ultimate Daily Moisturizer Sunscreen SPF 20 "octinox
ate, zinc oxide" CREAM TOPICAL 20130101 OTC MONOGRAPH NO
T FINAL part352 "Allergan, Inc." OCTINOXATE; ZINC OXIDE 75; 53 mg/g; mg
/g
0023-4963_0d9101b5-ef9e-421a-8ae8-c614b4cf425d 0023-4963 HUMAN OTC DRUG
SkinMedica Daily Physical Defense SPF 30 Sunscreen "Titanium Dioxid
e, zinc oxide" CREAM TOPICAL 20130101 OTC MONOGRAPH NOT FINAL
part352 "Allergan, Inc." TITANIUM DIOXIDE; ZINC OXIDE 73; 34 mg/g; mg
/g
0023-4964_2e3b5888-b8e2-4c52-9f53-f777701a603b 0023-4964 HUMAN OTC DRUG
SkinMedica Environmental Defense Sunscreen SPF 50 "Octinoxate, Oct
isalate, Octocrylene, Oxybenzone, Zinc Oxide" CREAM TOPICAL 20130101
OTC MONOGRAPH NOT FINAL part352 "Allergan, Inc." OCTINOXATE; OCTISALATE;
OCTOCRYLENE; OXYBENZONE; ZINC OXIDE 75; 50; 20; 60; 33 mg/g; mg/g; mg/g
; mg/g; mg/g
0023-4965_757fa897-abad-43a3-8f73-facd8bb0f521 0023-4965 HUMAN OTC DRUG
SkinMedica Acne Treatment benzoyl peroxide LOTION TOPICAL
20130101 OTC MONOGRAPH NOT FINAL part333D "Allergan, Inc."
BENZOYL PEROXIDE 25 mg/g
0023-7824_d4e588bc-ab78-4f31-9867-a2d6921c58b7 0023-7824 HUMAN PRESCRIPTI
ON DRUG Polytrim polymyxin b sulfate and trimethoprim sulfate
"Allergan, Inc." POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE 100000;
1 [USP'U]/mL; mg/mL "Polymyxin-class Antibacterial [EPC],Polymyxins
[Chemical/Ingredient],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihy
drofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organi
c Cation Transporter 2 Inhibitors [MoA]"
0023-8335_07a5c024-17aa-4198-87a7-8db5d0dfcd54 0023-8335 HUMAN PRESCRIPTI
ON DRUG TAZORAC tazarotene GEL CUTANEOUS 19970801
NDA NDA020600 "Allergan, Inc." TAZAROTENE 0.5 mg/g
0023-8694_3638e98c-d8f7-4fd5-9e95-c694b5fff976 0023-8694 HUMAN PRESCRIPTI
ON DRUG AZELEX azelaic acid CREAM CUTANEOUS 19960321
NDA NDA020428 "Allergan, Inc." AZELAIC ACID 0.2 g/g
"Decreased Protein Synthesis [PE],Decreased Sebaceous Gland Activity [PE]"
0023-8842_2f35a2aa-54f1-4abb-b1be-056b17a0d3c5 0023-8842 HUMAN PRESCRIPTI
ON DRUG ALOCRIL nedocromil sodium SOLUTION/ DROPS OPHTHALMIC
20000203 NDA NDA021009 "Allergan, Inc." NEDOCROM
IL SODIUM 20 mg/mL "Decreased Histamine Release [PE],Mast Cell Stab
ilizer [EPC]"
0023-9155_f00dc25e-c69b-4685-bdd0-48d8fd634ce3 0023-9155 HUMAN PRESCRIPTI
ON DRUG TAZORAC tazarotene CREAM CUTANEOUS 20001115
NDA NDA021184 "Allergan, Inc." TAZAROTENE 0.5 mg/g
0023-9156_f00dc25e-c69b-4685-bdd0-48d8fd634ce3 0023-9156 HUMAN PRESCRIPTI
ON DRUG TAZORAC tazarotene CREAM CUTANEOUS 20001113
0023-9163_f90b48b2-5c9c-4e7b-8b0c-cf23a9486f55 0023-9163 HUMAN PRESCRIPTI
ON DRUG RESTASIS cyclosporine EMULSION OPHTHALMIC
20030401 NDA NDA050790 "Allergan, Inc." CYCLOSPO
RINE 0.5 mg/mL "Calcineurin Inhibitor Immunosuppressant [EPC],Calcineur
in Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibito
rs [MoA]"
0023-9177_5aef5742-0096-4aee-ab72-1f21d83a3f23 0023-9177 HUMAN PRESCRIPTI
ON DRUG ALPHAGAN P brimonidine tartrate SOLUTION/ DROPS OPHTHALM
BRIMONIDINE TARTRATE 1.5 mg/mL "Adrenergic alpha-Agonists [MoA],alpha-A
drenergic Agonist [EPC]"
0023-9201_e2252a1e-b2f8-40f3-98f5-eacd97fa8683 0023-9201 HUMAN PRESCRIPTI
ON DRUG ELESTAT epinastine hydrochloride SOLUTION/ DROPS OPHTHALM
EPINASTINE HYDROCHLORIDE 0.5 mg/mL "Adrenergic Agonists [MoA],Adren
ergic Receptor Agonist [EPC],Decreased Histamine Release [PE],Histamine H1 Recep
tor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC]"
0023-9205_23a03f48-c918-4c61-bd2f-a3803620f781 0023-9205 HUMAN OTC DRUG
REFRESH LIQUIGEL Carboxymethylcellulose sodium GEL OPHTHALM
0023-9211_f39d9b4d-1cc3-4198-82bf-4bd976bdd360 0023-9211 HUMAN PRESCRIPTI
ON DRUG COMBIGAN "brimonidine tartrate, timolol maleate" SOLUTION
/ DROPS OPHTHALMIC 20071114 NDA NDA021398 "Allerga
n, Inc." BRIMONIDINE TARTRATE; TIMOLOL MALEATE 2; 5 mg/mL; mg/mL
"Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC],Adrenergic beta-
Antagonists [MoA],beta-Adrenergic Blocker [EPC]"
0023-9232_b35cb2f6-813a-4693-8a83-2879fe17d510 0023-9232 HUMAN PRESCRIPTI
ON DRUG BOTOX Cosmetic onabotulinumtoxinA "INJECTION, POWDER, LYOP
HILIZED, FOR SOLUTION" INTRAMUSCULAR 20020429 BLA BLA10300
0 "Allergan, Inc." BOTULINUM TOXIN TYPE A 100 [USP'U]/1
"Acetylcholine Release Inhibitor [EPC],Acetylcholine Release Inhibitors [MoA]"
0023-9236_cd77700e-efb3-455f-897f-b997013a989e 0023-9236 HUMAN PRESCRIPTI
ON DRUG AVAGE tazarotene CREAM CUTANEOUS 20030107
0023-9277_429300a4-c16b-4925-b202-ae83efb73d73 0023-9277 HUMAN PRESCRIPTI
ON DRUG ACULAR LS ketorolac tromethamine SOLUTION/ DROPS OPHTHALM
matory Drug [EPC]"
0023-9321_5aef5742-0096-4aee-ab72-1f21d83a3f23 0023-9321 HUMAN PRESCRIPTI
ON DRUG ALPHAGAN P brimonidine tartrate SOLUTION/ DROPS OPHTHALM
BRIMONIDINE TARTRATE 1 mg/mL "Adrenergic alpha-Agonists [MoA],alpha-A
drenergic Agonist [EPC]"
0023-9350_c6ed8e13-e1e4-4a85-9c39-836e6cdb7a9c 0023-9350 HUMAN PRESCRIPTI
ON DRUG SANCTURA XR trospium chloride "CAPSULE, EXTENDED RELEA
SE" ORAL 20071201 20150304 NDA NDA022103 "Allerga
n, Inc." TROSPIUM CHLORIDE 60 mg/1 "Cholinergic Muscarinic
Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]"
11980-011_c90cb2dd-aa2f-4070-b4bb-38e16359b438 11980-011 HUMAN PRESCRIPTI
ON DRUG BLEPH-10 sulfacetamide sodium SOLUTION/ DROPS OPHTHALM
SULFACETAMIDE SODIUM 100 mg/mL "Sulfonamide Antibacterial [EPC],Sulfona
mides [Chemical/Ingredient]"
11980-022_64d32a4e-ad4b-413a-a775-41e8c854bfc5 11980-022 HUMAN PRESCRIPTI
SUSPENSION/ DROPS OPHTHALMIC 19611001 NDA NDA01281
3 "Allergan, Inc." PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM
2; 100 mg/mL; mg/mL "Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/
Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]"
11980-174_97aa4882-30ae-4b81-981c-3e9ad500f02c 11980-174 HUMAN PRESCRIPTI
ON DRUG PRED MILD prednisolone acetate SUSPENSION/ DROPS
PREDNISOLONE ACETATE 1.2 mg/mL "Corticosteroid [EPC],Corticosteroid Hor
11980-180_17930688-83e2-47e7-93f2-c2f15bcff50a 11980-180 HUMAN PRESCRIPTI
ON DRUG PRED FORTE prednisolone acetate SUSPENSION/ DROPS
PREDNISOLONE ACETATE 10 mg/mL "Corticosteroid [EPC],Corticosteroid Hor
11980-211_d839481e-c5e5-442b-85f7-c634d50b97b9 11980-211 HUMAN PRESCRIPTI
ON DRUG FML fluorometholone SUSPENSION/ DROPS OPHTHALMIC
19720201 NDA NDA016851 "Allergan, Inc." FLUOROME
THOLONE 1 mg/mL "Corticosteroid [EPC],Corticosteroid Hormone Receptor Ag
onists [MoA]"
11980-228_86169620-8649-4b2d-aa5f-b7ab057f489b 11980-228 HUMAN PRESCRIPTI
ON DRUG FML FORTE fluorometholone SUSPENSION/ DROPS OPHTHALM
FLUOROMETHOLONE 2.5 mg/mL "Corticosteroid [EPC],Corticosteroid Hormone Rec
11980-779_c3b5609c-3d6a-4c9a-8f81-611d0fa19180 11980-779 HUMAN PRESCRIPTI
ON DRUG OCUFLOX ofloxacin SOLUTION/ DROPS OPHTHALMIC 19930801
NDA NDA019921 "Allergan, Inc." OFLOXACIN 3 mg/mL
11980-801_e41e9af7-b6ef-4c26-bbe9-5ea9e31f45c8 11980-801 HUMAN PRESCRIPTI
ON DRUG OCUFEN flurbiprofen sodium SOLUTION/ DROPS OPHTHALMIC
19870101 NDA NDA019404 "Allergan, Inc." FLURBIPR
OFEN SODIUM 0.3 mg/mL "Cyclooxygenase Inhibitors [MoA],Nonsteroidal An
rug [EPC]"
54575-081_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-081 HUMAN PRESCRIPTI
ON DRUG BAHIA GRASS POLLEN paspalum notatum pollen "INJECTION, SOLU
TION" PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA10137
6 "Allergy Laboratories, Inc." PASPALUM NOTATUM POLLEN 1 g/20mL
ON DRUG CULTIVATED BARLEY POLLEN hordeum vulgare pollen "INJECTI
ON, SOLUTION" PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA
BLA101376 "Allergy Laboratories, Inc." HORDEUM VULGARE POLLEN 1
g/20mL "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Re
ON DRUG CREEPING BENT GRASS POLLEN agrostis stolonifera pollen
"INJECTION, SOLUTION" PERCUTANEOUS; SUBCUTANEOUS 19671207
BLA BLA101376 "Allergy Laboratories, Inc." AGROSTIS STOLONIFERA POL
LEN 1 g/20mL "Increased IgG Production [PE],Pollen [Chemical/Ingredie
nt],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [
EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE]"
54575-084_a3c0a62e-9b1b-41bf-9f8c-c0b58e36395c 54575-084 HUMAN PRESCRIPTI
ON DRUG STANDARDIZED BERMUDA GRASS POLLEN Cynodon dactylon pollen
BLA BLA101379 "Allergy Laboratories, Inc." CYNODON DACTYLON POLLEN
ON DRUG ANNUAL BLUEGRASS POLLEN poa annua pollen "INJECTION, SOLU
6 "Allergy Laboratories, Inc." POA ANNUA POLLEN 1 g/20mL
ON DRUG STANDARDIZED KENTUCKY BLUEGRASS POLLEN Poa pratensis pollen
BLA BLA101380 "Allergy Laboratories, Inc." POA PRATENSIS POLLEN
ON DRUG HUNGARIAN SMOOTH BROME POLLEN bromus inermis pollen "INJECTI
BLA101376 "Allergy Laboratories, Inc." BROMUS INERMIS POLLEN 1
mical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allerg
enic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],
Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/I
ngredient]"
ON DRUG CANARY GRASS POLLEN phalaris minor pollen "INJECTION, SOLU
6 "Allergy Laboratories, Inc." PHALARIS MINOR POLLEN 1 g/20mL
ON DRUG SOUTHERN CHEAT CHESS POLLEN bromus secalinus pollen "INJECTI
BLA101376 "Allergy Laboratories, Inc." BROMUS SECALINUS POLLEN 1
ON DRUG CULTIVATED CORN POLLEN zea mays pollen "INJECTION, SOLUTION"
PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376
"Allergy Laboratories, Inc." ZEA MAYS POLLEN 1 g/20mL "Non-Standardize
ON DRUG STANDARDIZED MEADOW FESCUE GRASS POLLEN Festuca elatior pollen
BLA BLA101381 "Allergy Laboratories, Inc." FESTUCA PRATENSIS POLLEN
ON DRUG BLUE GRAMA GRASS bouteloua gracilis pollen "INJECTI
BLA101376 "Allergy Laboratories, Inc." BOUTELOUA GRACILIS POLLEN
1 g/20mL "Non-Standardized Pollen Allergenic Extract [EPC],Increased Hist
ON DRUG JOHNSON GRASS POLLEN sorghum halepense pollen "INJECTI
BLA101376 "Allergy Laboratories, Inc." SORGHUM HALEPENSE POLLEN
ON DRUG TALL OAT GRASS POLLEN arrhenatherum elatius pollen "INJECTI
BLA101376 "Allergy Laboratories, Inc." ARRHENATHERUM ELATIUS POLLEN
ON DRUG CULTIVATED OATS POLLEN avena sativa pollen "INJECTION, SOLU
6 "Allergy Laboratories, Inc." AVENA SATIVA POLLEN 1 g/20mL
ON DRUG STANDARDIZED ORCHARD GRASS POLLEN Dactylis glomerata polle
n "INJECTION, SOLUTION" PERCUTANEOUS; SUBCUTANEOUS 19970529
BLA BLA101382 "Allergy Laboratories, Inc." DACTYLIS GLOMERATA POLLE
N 100000 [BAU]/mL "Standardized Pollen Allergenic Extract [EPC],In
ON DRUG QUACK GRASS POLLEN elymus repens pollen "INJECTION, SOLU
6 "Allergy Laboratories, Inc." ELYMUS REPENS POLLEN 1 g/20mL
ON DRUG STANDARDIZED REDTOP GRASS POLLEN Agrostis alba pollen
BLA BLA101383 "Allergy Laboratories, Inc." AGROSTIS GIGANTEA POLLEN
100000 [BAU]/mL "Standardized Pollen Allergenic Extract [EPC],Non-Standa
rdized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-med
iated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],A
llergens [Chemical/Ingredient]"
ON DRUG ITALIAN RYEGRASS POLLEN lolium perenne subsp. multiflorum pollen
BLA BLA101376 "Allergy Laboratories, Inc." LOLIUM PERENNE SUBSP. MU
LTIFLORUM POLLEN 1 g/20mL "Non-Standardized Pollen Allergenic Extr
]"
ON DRUG STANDARDIZED PERENNIAL RYEGRASS GRASS POLLEN Lolium perenne p
ollen "INJECTION, SOLUTION" PERCUTANEOUS; SUBCUTANEOUS 19970625
BLA BLA101384 "Allergy Laboratories, Inc." LOLIUM PERENNE POLLEN
ON DRUG GRAIN SORGHUM POLLEN sorghum bicolor subsp. bicolor pollen
BLA BLA101376 "Allergy Laboratories, Inc." SORGHUM BICOLOR SUBSP. B
ICOLOR POLLEN 1 g/20mL "Non-Standardized Pollen Allergenic Extract [EPC
ON DRUG SUDAN GRASS POLLEN sorghum bicolor subsp. drummondii pollen
BLA BLA101376 "Allergy Laboratories, Inc." SORGHUM BICOLOR SUBSP. D
RUMMONDII POLLEN 1 g/20mL "Non-Standardized Pollen Allergenic Extr
]"
ON DRUG STANDARDIZED SWEET VERNAL GRASS POLLEN Anthoxanthum odoratum po
llen "INJECTION, SOLUTION" PERCUTANEOUS; SUBCUTANEOUS 19970529
BLA BLA101385 "Allergy Laboratories, Inc." ANTHOXANTHUM ODORATUM PO
LLEN 100000 [BAU]/mL "Standardized Pollen Allergenic Extract [EPC],In
ON DRUG STANDARDIZED TIMOTHY GRASS POLLEN Phleum pratense pollen
BLA BLA101386 "Allergy Laboratories, Inc." PHLEUM PRATENSE POLLEN
ON DRUG CULTIVATED WHEAT POLLEN triticum aestivum pollen "INJECTI
BLA101376 "Allergy Laboratories, Inc." TRITICUM AESTIVUM POLLEN
emical/Ingredient]"
ON DRUG WESTERN WHEAT POLLEN pascopyrum smithii pollen "INJECTI
BLA101376 "Allergy Laboratories, Inc." PASCOPYRUM SMITHII POLLEN
ON DRUG ALFALFA POLLEN medicago sativa pollen "INJECTION, SOLUTION"
"Allergy Laboratories, Inc." MEDICAGO SATIVA POLLEN 1 g/20mL "Non-Sta
ON DRUG SWEET CLOVER POLLEN melilotus albus pollen "INJECTION, SOLU
6 "Allergy Laboratories, Inc." MELILOTUS ALBUS POLLEN 1 g/20mL
ON DRUG SUGAR BEET POLLEN beta vulgaris pollen "INJECTION, SOLU
6 "Allergy Laboratories, Inc." BETA VULGARIS POLLEN 1 g/20mL
ON DRUG WESTERN JUNE GRASS POLLEN koeleria macrantha pollen
BLA BLA101376 "Allergy Laboratories, Inc." KOELERIA MACRANTHA POLLE
N 1 g/20mL "Non-Standardized Pollen Allergenic Extract [EPC],Increa
ON DRUG BROOMWEED POLLEN amphiachyris dracunculoides pollen
BLA BLA101376 "Allergy Laboratories, Inc." AMPHIACHYRIS DRACUNCULOI
DES POLLEN 1 g/20mL "Non-Standardized Pollen Allergenic Extract [EPC
ON DRUG CARELESS WEED POLLEN amaranthus palmeri pollen "INJECTI
BLA101376 "Allergy Laboratories, Inc." AMARANTHUS PALMERI POLLEN
ON DRUG COCKLEBUR POLLEN xanthium strumarium pollen "INJECTI
BLA101376 "Allergy Laboratories, Inc." XANTHIUM STRUMARIUM POLLEN
ON DRUG YELLOW CURLY DOCK POLLEN rumex crispus pollen "INJECTI
BLA101376 "Allergy Laboratories, Inc." RUMEX CRISPUS POLLEN 1
ON DRUG FIREBUSH KOCHIA POLLEN kochia scoparia pollen "INJECTION, SOLU
6 "Allergy Laboratories, Inc." KOCHIA SCOPARIA POLLEN 1 g/20mL
ON DRUG GOLDENROD POLLEN solidago canadensis pollen "INJECTI
BLA101376 "Allergy Laboratories, Inc." SOLIDAGO CANADENSIS POLLEN
ON DRUG GREASEWOOD POLLEN sarcobatus vermiculatus pollen "INJECTI
BLA101376 "Allergy Laboratories, Inc." SARCOBATUS VERMICULATUS POLLEN
ON DRUG GROUNDSEL TREE POLLEN baccharis halimifolia pollen "INJECTI
BLA101376 "Allergy Laboratories, Inc." BACCHARIS HALIMIFOLIA POLLEN
ON DRUG NETTLE POLLEN urtica dioica pollen "INJECTION, SOLUTION"
"Allergy Laboratories, Inc." URTICA DIOICA POLLEN 1 g/20mL "Non-Sta
ON DRUG LAMBS QUARTERS POLLEN chenopodium album pollen "INJECTI
BLA101376 "Allergy Laboratories, Inc." CHENOPODIUM ALBUM POLLEN
ON DRUG BURWEED MARSHELDER POLLEN iva xanthifolia pollen "INJECTI
BLA101376 "Allergy Laboratories, Inc." IVA XANTHIFOLIA POLLEN 1
ON DRUG NARROWLEAF MARSHELDER POLLEN iva angustifolia pollen "INJECTI
BLA101376 "Allergy Laboratories, Inc." IVA ANGUSTIFOLIA POLLEN 1
ON DRUG ROUGH MARSHELDER POLLEN iva annua var. annua pollen "INJECTI
BLA101376 "Allergy Laboratories, Inc." IVA ANNUA VAR. ANNUA POLLEN
ON DRUG COMMON MUGWORT POLLEN artemisia vulgaris pollen "INJECTI
BLA101376 "Allergy Laboratories, Inc." ARTEMISIA VULGARIS POLLEN
ON DRUG SPINY PIGWEED POLLEN amaranthus spinosus pollen "INJECTI
BLA101376 "Allergy Laboratories, Inc." AMARANTHUS SPINOSUS POLLEN
ON DRUG ROUGH REDROOT PIGWEED POLLEN amaranthus retroflexus pollen
BLA BLA101376 "Allergy Laboratories, Inc." AMARANTHUS RETROFLEXUS P
OLLEN 1 g/20mL "Non-Standardized Pollen Allergenic Extract [EPC],Increa
ON DRUG "PIGWEED MIX, ROUGH/SPINY POLLEN" amaranthus retroflexus p
ollen and amaranthus spinosus pollen "INJECTION, SOLUTION" PERCUTANEOUS; SU
BCUTANEOUS 19671207 BLA BLA101376 "Allergy Laborat
ories, Inc." AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLEN
.5; .5 g/20mL; g/20mL "Non-Standardized Pollen Allergenic Extract [EPC],Increa
EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemic
al/Ingredient],Allergens [Chemical/Ingredient]"
ON DRUG ENGLISH PLANTAIN POLLEN plantago lanceolata pollen "INJECTI
BLA101376 "Allergy Laboratories, Inc." PLANTAGO LANCEOLATA POLLEN
ON DRUG FALSE BUR RAGWEED POLLEN ambrosia acanthicarpa pollen
BLA BLA101376 "Allergy Laboratories, Inc." AMBROSIA ACANTHICARPA PO
LLEN 1 g/20mL "Non-Standardized Pollen Allergenic Extract [EPC],Increa
ON DRUG GIANT RAGWEED POLLEN ambrosia trifida pollen "INJECTION, SOLU
6 "Allergy Laboratories, Inc." AMBROSIA TRIFIDA POLLEN 1 g/20mL
Ingredient]"
ON DRUG STANDARDIZED SHORT RAGWEED POLLEN ambrosia artemisiifolia
pollen "INJECTION, SOLUTION" PERCUTANEOUS; SUBCUTANEOUS 19820126
BLA BLA101387 "Allergy Laboratories, Inc." AMBROSIA ARTEMISIIFOLIA
POLLEN 1 g/10mL "Standardized Pollen Allergenic Extract [EPC],Increased
ON DRUG WESTERN RAGWEED POLLEN ambrosia psilostachya pollen "INJECTI
BLA101376 "Allergy Laboratories, Inc." AMBROSIA PSILOSTACHYA POLLEN
ON DRUG "3-RAGWEED MIX, GIANT/SHORT/WESTERN POLLEN" ambrosia psilost
achya pollen and ambrosia trifida pollen and ambrosia artemisiifolia pollen
BLA BLA101376 "Allergy Laboratories, Inc." AMBROSIA ARTEMISIIFOLIA
POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN .34; .33; .33
g/20mL; g/20mL; g/20mL "Non-Standardized Pollen Allergenic Extract [EPC],Increa
al/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Ex
ed IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredie
nt]"
ON DRUG RUSSIAN THISTLE POLLEN salsola kali pollen "INJECTION, SOLU
6 "Allergy Laboratories, Inc." SALSOLA KALI POLLEN 1 g/20mL
ON DRUG COMMON BIG SAGEBRUSH POLLEN artemisia tridentata pollen
BLA BLA101376 "Allergy Laboratories, Inc." ARTEMISIA TRIDENTATA POL
LEN 1 g/20mL "Non-Standardized Pollen Allergenic Extract [EPC],Increa
ON DRUG PRAIRIE SAGE POLLEN artemisia frigida pollen "INJECTI
BLA101376 "Allergy Laboratories, Inc." ARTEMISIA FRIGIDA POLLEN
ON DRUG "SAGE MIX, COMMON/DARK-LEAVED/DRAGON/PASTURE POLLEN" artemisi
a ludoviciana pollen and artemisia tridentata pollen and artemisia dracunculus p
ollen and artemisia frigida pollen "INJECTION, SOLUTION" PERCUTANEOUS; SU
ories, Inc." ARTEMISIA DRACUNCULUS POLLEN; ARTEMISIA FRIGIDA POLLEN; ARTEMISI
A LUDOVICIANA POLLEN; ARTEMISIA TRIDENTATA POLLEN .25; .25; .25; .25
g/20mL; g/20mL; g/20mL; g/20mL "Non-Standardized Pollen Allergenic Extract [EPC
],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/
Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic E
xtract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen
[Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen A
[PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemi
cal/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Hista
mine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Aller
ON DRUG ANNUAL SALTBUSH POLLEN atriplex wrightii pollen "INJECTI
BLA101376 "Allergy Laboratories, Inc." ATRIPLEX WRIGHTII POLLEN
ON DRUG SHADSCALE POLLEN atriplex confertifolia pollen "INJECTI
BLA101376 "Allergy Laboratories, Inc." ATRIPLEX CONFERTIFOLIA POLLEN
emical/Ingredient]"
ON DRUG SOUR DOCK SHEEP SORREL POLLEN rumex acetosella pollen "INJECTI
BLA101376 "Allergy Laboratories, Inc." RUMEX ACETOSELLA POLLEN 1
g/20mL "Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity
[PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Hista
mine Release [PE],Allergens [Chemical/Ingredient]"
ON DRUG WATER HEMP POLLEN amaranthus tuberculatus pollen "INJECTI
BLA101376 "Allergy Laboratories, Inc." AMARANTHUS TUBERCULATUS POLLEN
rgens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Inc
reased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Producti
on [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
ON DRUG WINGSCALE POLLEN atriplex canescens pollen "INJECTI
BLA101376 "Allergy Laboratories, Inc." ATRIPLEX CANESCENS POLLEN
ON DRUG ANNUAL WORMWOOD POLLEN artemisia annua pollen "INJECTION, SOLU
6 "Allergy Laboratories, Inc." ARTEMISIA ANNUA POLLEN 1 g/20mL
Ingredient]"
ON DRUG COMMON WORMWOOD POLLEN artemisia absinthium pollen "INJECTI
BLA101376 "Allergy Laboratories, Inc." ARTEMISIA ABSINTHIUM POLLEN
ON DRUG MEXICAN TEA POLLEN chenopodium ambrosioides pollen "INJECTI
BLA101376 "Allergy Laboratories, Inc." CHENOPODIUM AMBROSIOIDES POLLEN
ON DRUG "DOCK MIX, SOUR SHEEP SORREL/YELLOW POLLEN" rumex acetosella
pollen and rumex crispus pollen "INJECTION, SOLUTION" PERCUTANEOUS; SU
ories, Inc." RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN .5; .5 g/20mL;
mine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allerg
ngredient]"
ON DRUG "STANDARDIZED RAGWEED MIX, GIANT/SHORT" ambrosia trifida pollen
and ambrosia artemisiifolia pollen "INJECTION, SOLUTION" PERCUTANEOUS; SU
ories, Inc." AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA TRIFIDA POLLEN .5; .5
g/20mL; g/20mL "Non-Standardized Pollen Allergenic Extract [EPC],Increased Hist
rgens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increas
PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
ON DRUG DANDELION POLLEN taraxacum officinale pollen "INJECTI
BLA101376 "Allergy Laboratories, Inc." TARAXACUM OFFICINALE POLLEN
ON DRUG SUNFLOWER POLLEN helianthus annuus pollen "INJECTI
BLA101376 "Allergy Laboratories, Inc." HELIANTHUS ANNUUS POLLEN
ON DRUG ALTERNARIA TENUIS ALTERNATA alternaria alternata "INJECTI
BLA101376 "Allergy Laboratories, Inc." ALTERNARIA ALTERNATA 1
g/20mL "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Re
ON DRUG ASPERGILLUS FUMIGATUS aspergillus fumigatus "INJECTION, SOLU
6 "Allergy Laboratories, Inc." ASPERGILLUS FUMIGATUS 1 g/20mL
E],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [
ON DRUG ASPERGILLUS GLAUCUS eurotium herbariorum "INJECTION, SOLU
6 "Allergy Laboratories, Inc." EUROTIUM HERBARIORUM 1 g/20mL
ON DRUG ASPERGILLUS NIGER aspergillus niger var. niger "INJECTI
BLA101376 "Allergy Laboratories, Inc." ASPERGILLUS NIGER VAR. NIGER
1 g/20mL "Non-Standardized Fungal Allergenic Extract [EPC],Increased Hist
ON DRUG ASPERGILLUS TERREUS aspergillus terreus "INJECTION, SOLU
6 "Allergy Laboratories, Inc." ASPERGILLUS TERREUS 1 g/20mL
ON DRUG PULLULARIA PULLULANS aureobasidium pullulans var. pullutans
BLA BLA101376 "Allergy Laboratories, Inc." AUREOBASIDIUM PULLULANS
VAR. PULLUTANS 1 g/20mL "Non-Standardized Fungal Allergenic Extract [EPC
t]"
ON DRUG BOTRYTIS CINEREA botrytis cinerea "INJECTION, SOLU
6 "Allergy Laboratories, Inc." BOTRYTIS CINEREA 1 g/20mL
ON DRUG CANDIDA MONILA ALBICANS candida albicans "INJECTION, SOLU
6 "Allergy Laboratories, Inc." CANDIDA ALBICANS 1 g/20mL
"Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chem
ical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allerge
nic Extract [EPC],Increased Histamine Release [PE]"
ON DRUG CEPHALOSPORIUM ACREMONIUM acremonium strictum "INJECTI
BLA101376 "Allergy Laboratories, Inc." ACREMONIUM STRICTUM 1
ON DRUG CEPHALOTHECIUM ROSEUM trichothecium roseum "INJECTION, SOLU
6 "Allergy Laboratories, Inc." TRICHOTHECIUM ROSEUM 1 g/20mL
ON DRUG CHAETOMIUM GLOBOSUM chaetomium globosum "INJECTION, SOLU
6 "Allergy Laboratories, Inc." CHAETOMIUM GLOBOSUM 1 g/20mL
ON DRUG CLADOSPORIUM FULVUM passalora fulva "INJECTION, SOLUTION"
"Allergy Laboratories, Inc." PASSALORA FULVA 1 g/20mL "Non-Standardize
ON DRUG CURVULARIA SPICIFERA cochliobolus spicifer "INJECTION, SOLU
6 "Allergy Laboratories, Inc." COCHLIOBOLUS SPICIFER 1 g/20mL
ON DRUG EPICOCCUM NIGRUM epicoccum nigrum "INJECTION, SOLU
6 "Allergy Laboratories, Inc." EPICOCCUM NIGRUM 1 g/20mL
"Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [
Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased
Histamine Release [PE],Cell-mediated Immunity [PE]"
ON DRUG EPIDERMOPHYTON FLOCCOSUM epidermophyton floccosum
BLA BLA101376 "Allergy Laboratories, Inc." EPIDERMOPHYTON FLOCCOSUM
ON DRUG FUSARIUM VASINFECTUM OXYSPORUM fusarium oxysporum vasinfectum
BLA BLA101376 "Allergy Laboratories, Inc." FUSARIUM OXYSPORUM VASIN
FECTUM 1 g/20mL "Non-Standardized Fungal Allergenic Extract [EPC],Increa
ON DRUG FUSARIUM SOLANI haematonectria haematococca "INJECTION, SOLU
6 "Allergy Laboratories, Inc." HAEMATONECTRIA HAEMATOCOCCA 1
ON DRUG GEOTRICHUM CANDIDUM geotrichum candidum "INJECTION, SOLU
6 "Allergy Laboratories, Inc." GEOTRICHUM CANDIDUM 1 g/20mL
ON DRUG HELMINTHOSPORIUM SATIVUM cochliobolus sativus "INJECTI
BLA101376 "Allergy Laboratories, Inc." COCHLIOBOLUS SATIVUS 1
ON DRUG HORMODENDRUM CLADOSPORIUM CLADOSPORIOIDES cladosporium cla
dosporioides "INJECTION, SOLUTION" PERCUTANEOUS; SUBCUTANEOUS 19671207
BLA BLA101376 "Allergy Laboratories, Inc." CLADOSPORIUM CLADOSPORIO
IDES 1 g/20mL "Non-Standardized Fungal Allergenic Extract [EPC],Increa
ON DRUG MUCOR PLUMBEUS mucor plumbeus "INJECTION, SOLUTION" PERCUTAN
EOUS; SUBCUTANEOUS 19671207 BLA BLA101376 "Allergy
Laboratories, Inc." MUCOR PLUMBEUS 1 g/20mL "Non-Standardized Fungal
ON DRUG MUCOR RACEMOSUS mucor racemosus "INJECTION, SOLUTION" PERCUTAN
Laboratories, Inc." MUCOR RACEMOSUS 1 g/20mL "Non-Standardized Fungal
ON DRUG NEUROSPORA SITOPHILA neurospora sitophila "INJECTION, SOLU
6 "Allergy Laboratories, Inc." NEUROSPORA SITOPHILA 1 g/20mL
ON DRUG NIGROSPORA SPHAERICA khuskia oryzae "INJECTION, SOLUTION"
"Allergy Laboratories, Inc." KHUSKIA ORYZAE 1 g/20mL "Non-Standardize
ON DRUG PENICILLIUM NOTATUM CHRYSOGENUM penicillium chrysogenum var. chr
ysogenum "INJECTION, SOLUTION" PERCUTANEOUS; SUBCUTANEOUS 19671207
BLA BLA101376 "Allergy Laboratories, Inc." PENICILLIUM CHRYSOGENUM
VAR. CHRYSOGENUM 1 g/20mL "Non-Standardized Fungal Allergenic Extr
ngredient]"
ON DRUG PHOMA DESTRUCTIVA phoma destructiva "INJECTION, SOLU
6 "Allergy Laboratories, Inc." PHOMA DESTRUCTIVA 1 g/20mL
ON DRUG RHIZOPUS NIGRICANS rhizopus stolonifer "INJECTION, SOLU
6 "Allergy Laboratories, Inc." RHIZOPUS STOLONIFER 1 g/20mL
ON DRUG RHODOTORULA MUCILAGINOSA rhodotorula mucilaginosa
BLA BLA101376 "Allergy Laboratories, Inc." RHODOTORULA MUCILAGINOSA
ON DRUG SPONDYLOCLADIUM ATROVIRENS helminthosporium solani "INJECTI
BLA101376 "Allergy Laboratories, Inc." HELMINTHOSPORIUM SOLANI 1
ON DRUG STEMPHYLIUM SARCINIFORME stemphylium sarciniforme
BLA BLA101376 "Allergy Laboratories, Inc." STEMPHYLIUM SARCINIFORME
ON DRUG TRICHODERMA LIGNORUM trichoderma viride "INJECTION, SOLU
6 "Allergy Laboratories, Inc." TRICHODERMA VIRIDE 1 g/20mL
ON DRUG TRICHOPHYTON MENTAGROPHYTES trichophyton mentagrophytes
BLA BLA101376 "Allergy Laboratories, Inc." TRICHOPHYTON MENTAGROPHY
TES 1 g/20mL "Non-Standardized Fungal Allergenic Extract [EPC],Increa
ON DRUG TRICHOPHYTON RUBRUM trichophyton rubrum "INJECTION, SOLU
6 "Allergy Laboratories, Inc." TRICHOPHYTON RUBRUM 1 g/20mL
ON DRUG TRICHOPHYTON TONSURANS trichophyton tonsurans "INJECTION, SOLU
6 "Allergy Laboratories, Inc." TRICHOPHYTON TONSURANS 1 g/20mL
ON DRUG VERTICILLIUM ALBO ATRUM verticillium albo-atrum "INJECTION, SOLU
6 "Allergy Laboratories, Inc." VERTICILLIUM ALBO-ATRUM 1 g/20mL
ON DRUG RINKEL MOLD MIX A aspergillus fumigatus and botrytis ciner
ea and chaetomium globosum and epicoccum nigrum and fusarium oxysporum vasinfect
um and cochliobolus sativus and neurospora sitophila and mucor plumbeus and phom
BLA BLA101376 "Allergy Laboratories, Inc." ASPERGILLUS FUMIGATUS; A
UREOBASIDIUM PULLULANS VAR. PULLUTANS; BOTRYTIS CINEREA; CHAETOMIUM GLOBOSUM; CO
CHLIOBOLUS SATIVUS; EPICOCCUM NIGRUM; FUSARIUM OXYSPORUM VASINFECTUM; GEOTRICHUM
CANDIDUM; MUCOR PLUMBEUS; NEUROSPORA SITOPHILA; PENICILLIUM CHRYSOGENUM VAR. CH
RYSOGENUM; PHOMA EXIGUA VAR. EXIGUA; RHIZOPUS STOLONIFER; RHODOTORULA MUCILAGINO
SA; SACCHAROMYCES CEREVISIAE .066; .067; .066; .066; .067; .066; .066; .067;
.067; .067; .067; .067; .067; .067; .067 g/20mL; g/20mL; g/20mL; g/20mL;
g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL;
lease [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],All
ergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],In
ion [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],N
on-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE]
,Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chem
emical/Ingredient],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingre
dient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extrac
t [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Non-Standar
dized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-medi
ated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingre
t [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased I
gG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ing
redient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Re
eins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fung
al Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immun
ity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],All
emical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Hi
stamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],F
ungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standar
ated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient]
,Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extrac
t [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Relea
se [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Aller
gens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardize
ON DRUG RINKEL MOLD MIX B trichothecium roseum and passalora fulva
and cochliobolus spicifer and myrothecium verrucaria and trichophyton schoenlei
nii and mycogone nigra and neurospora crassa and khuskia oryzae and paecilomyces
BLA BLA101376 "Allergy Laboratories, Inc." COCHLIOBOLUS SPICIFER; H
ELMINTHOSPORIUM SOLANI; KHUSKIA ORYZAE; MICROASCUS BREVICAULIS; MYCOGONE NIGRA;
MYROTHECIUM VERRUCARIA; NEUROSPORA CRASSA; PAECILOMYCES VARIOTII; PASSALORA FULV
A; PLEOSPORA TARDA; STREPTOMYCES GRISEUS; TRICHODERMA VIRIDE; TRICHOPHYTON SCHOE
NLEINII; TRICHOTHECIUM ROSEUM .071; .072; .071; .072; .071; .071; .071; .072;
.071; .072; .072; .072; .071; .071 g/20mL; g/20mL; g/20mL; g/20mL; g/20mL;
g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL "Non-Sta
ngredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Ex
e Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal
Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized
Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated I
t],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release
[PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [
Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal All
E],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens
[Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increase
d Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [P
E],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Sta
/Ingredient],Non-Standardized Bacterial Allergenic Extract [EPC],Increased Hista
mine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Bact
erial Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standar
dient],Allergens [Chemical/Ingredient]"
ON DRUG RINKEL MOLD MIX C absidia capillata and acrothecium robust
um and microsporum audouinii and microsporum canis and apiospora montagnei and p
hycomyces blakesleeanus and sporotrichum pruinosum and stachybotrys chartarum an
BLA BLA101376 "Allergy Laboratories, Inc." ABSIDIA CAPILLATA; ACROT
HECIUM ROBUSTUM; APIOSPORA MONTAGNEI; MICROSPORUM AUDOUINII; MICROSPORUM CANIS;
PHYCOMYCES BLAKESLEEANUS; SPOROTRICHUM PRUINOSUM; STACHYBOTRYS CHARTARUM; SYNCEP
HALASTRUM RACEMOSUM; TETRACOCCOSPORIUM PAXIANUM; THERMOMYCES LANUGINOSUS; TRICHO
SPORON CUTANEUM; VERTICILLIUM ALBO-ATRUM .076; .077; .077; .077; .077; .0
77; .077; .077; .077; .077; .077; .077; .077 g/20mL; g/20mL; g/20mL; g/20mL;
g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL "Non-Sta
mmunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredien
Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
ON DRUG BERMUDA GRASS SMUT ustilago cynodontis "INJECTION, SOLU
6 "Allergy Laboratories, Inc." USTILAGO CYNODONTIS 1 g/20mL
ON DRUG CORN SMUT ustilago maydis "INJECTION, SOLUTION" PERCUTAN
Laboratories, Inc." USTILAGO MAYDIS 1 g/20mL "Non-Standardized Fungal
ON DRUG JOHNSON GRASS SMUT sporisorium cruentum "INJECTION, SOLU
6 "Allergy Laboratories, Inc." SPORISORIUM CRUENTUM 1 g/20mL
ON DRUG WHEAT RUST puccinia graminis "INJECTION, SOLUTION"
"Allergy Laboratories, Inc." PUCCINIA GRAMINIS 1 g/20mL "Non-Sta
ON DRUG COTTON SEED FOR DIAGNOSTIC USE ONLY cotton seed "INJECTI
BLA101376 "Allergy Laboratories, Inc." COTTON SEED 1 g/20mL
"Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE
],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/
Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical
/Ingredient]"
ON DRUG FLAX SEED FOR DIAGNOSTIC USE ONLY flax seed "INJECTI
BLA101376 "Allergy Laboratories, Inc." FLAX SEED 1 g/20mL
"Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergeni
reased IgG Production [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Che
mical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Ch
emical/Ingredient]"
ON DRUG HOUSE DUST house dust "INJECTION, SOLUTION" PERCUTAN
Laboratories, Inc." HOUSE DUST 1 g/20mL "Non-Standardized House
Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Imm
unity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House D
ust [Chemical/Ingredient]"
ON DRUG KAPOK ceiba pentandra fiber "INJECTION, SOLUTION" PERCUTAN
Laboratories, Inc." CEIBA PENTANDRA FIBER 1 g/20mL "Non-Standardize
d Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-med
iated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingre
ON DRUG ORRIS ROOT iris germanica var. florentina root "INJECTI
BLA101376 "Allergy Laboratories, Inc." IRIS GERMANICA VAR. FLORENTINA R
OOT 1 g/20mL "Increased Histamine Release [PE],Cell-mediated Immunity
[PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Non-Standard
ized Plant Allergenic Extract [EPC],Plant Proteins [Chemical/Ingredient]"
ON DRUG PYRETHRUM tanacetum cinerariifolium flower "INJECTI
BLA101376 "Allergy Laboratories, Inc." TANACETUM CINERARIIFOLIUM FLOWER
1 g/20mL "Non-Standardized Plant Allergenic Extract [EPC],Increased Hista
mine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Alle
rgens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient]"
ON DRUG SILK bombyx mori fiber "INJECTION, SOLUTION" PERCUTAN
Laboratories, Inc." BOMBYX MORI FIBER 1 g/20mL "Non-Standardize
t],Silk [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
ON DRUG COTTON LINTERS cotton fiber "INJECTION, SOLUTION" PERCUTAN
Laboratories, Inc." COTTON FIBER 1 g/20mL "Non-Standardized Plant
Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Im
munity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],A
54575-288_26d83173-bf33-4460-ac59-b46f052d9787 54575-288 HUMAN PRESCRIPTI
ON DRUG Standardized Cat Hair Felis Domesticus Hair "INJECTION, SOLU
4 "Allergy Laboratories, Inc." FELIS CATUS HAIR 10000 [BAU]/mL
cal/Ingredient]"
ON DRUG CATTLE HAIR AND EPITHELIA bos taurus hair and bos taurus s
kin "INJECTION, SOLUTION" PERCUTANEOUS; SUBCUTANEOUS 19671207
BLA BLA101376 "Allergy Laboratories, Inc." BOS TAURUS HAIR; BOS TAU
RUS SKIN 1; 1 g/20mL; g/20mL "Non-Standardized Animal Hair Allergenic
eased IgG Production [PE],Allergens [Chemical/Ingredient],Fur [Chemical/Ingredie
nt],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Re
lease [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epid
ermal [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
ON DRUG DOG HAIR AND EPITHELIA canis lupus familiaris hair and canis lu
pus familiaris skin "INJECTION, SOLUTION" PERCUTANEOUS; SUBCUTANEOUS
19671207 BLA BLA101376 "Allergy Laboratories, Inc."
CANIS LUPUS FAMILIARIS HAIR; CANIS LUPUS FAMILIARIS SKIN 1; 1 g/20mL;
g/20mL "Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histami
ne Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [C
hemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Skin
y [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Alle
ON DRUG CHICKEN FEATHERS gallus gallus feather "INJECTION, SOLU
6 "Allergy Laboratories, Inc." GALLUS GALLUS FEATHER 1 g/20mL
"Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [
PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical
ON DRUG DUCK FEATHERS anas platyrhynchos feather "INJECTION, SOLU
6 "Allergy Laboratories, Inc." ANAS PLATYRHYNCHOS FEATHER 1
g/20mL "Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine R
elease [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens
ON DRUG GOOSE FEATHERS anser anser feather "INJECTION, SOLUTION"
"Allergy Laboratories, Inc." ANSER ANSER FEATHER 1 g/20mL "Non-Sta
ndardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell
-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingre
dient]"
ON DRUG "FEATHER MIX, CHICKEN/DUCK/GOOSE" gallus gallus feather an
d anas platyrhynchos feather and anser anser feather "INJECTION, SOLUTION"
"Allergy Laboratories, Inc." ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER;
GALLUS GALLUS FEATHER .33; .34; .33 g/20mL; g/20mL; g/20mL "Non-Standardize
d Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediate
d Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],All
ergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],I
ncreased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/I
ngredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic E
xtract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathe
rs [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
ON DRUG GUINEA PIG HAIR AND EPITHELIA cavia porcellus hair and cavia p
orcellus skin "INJECTION, SOLUTION" PERCUTANEOUS; SUBCUTANEOUS 19671207
BLA BLA101376 "Allergy Laboratories, Inc." CAVIA PORCELLUS HAIR; CA
VIA PORCELLUS SKIN .5; .5 g/20mL; g/20mL "Non-Standardized Animal Hair Al
PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fur [Chemical/
Ingredient],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Hist
amine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cel
ls, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
ON DRUG HAMSTER HAIR AND EPITHELIA mesocricetus auratus skin
BLA BLA101376 "Allergy Laboratories, Inc." MESOCRICETUS AURATUS SKI
N 1 g/20mL "Non-Standardized Animal Skin Allergenic Extract [EPC],I
ncreased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Produc
tion [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient]
"
ON DRUG HOG HAIR AND EPITHELIA sus scrofa hair and sus scrofa skin
BLA BLA101376 "Allergy Laboratories, Inc." SUS SCROFA HAIR; SUS SCR
OFA SKIN 1; 1 g/20mL; g/20mL "Non-Standardized Animal Hair Allergenic
eased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredie
nt],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Re
lease [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epid
ermal [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
ON DRUG HORSE HAIR AND DANDER equus caballus hair and equus caballus s
kin "INJECTION, SOLUTION" PERCUTANEOUS; SUBCUTANEOUS 19671207
BLA BLA101376 "Allergy Laboratories, Inc." EQUUS CABALLUS HAIR; EQU
US CABALLUS SKIN .5; .5 g/20mL; g/20mL "Non-Standardized Animal Hair Al
PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/
Ingredient],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Hist
amine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cel
ls, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
ON DRUG MOUSE HAIR AND EPITHELIA mus musculus skin "INJECTI
BLA101376 "Allergy Laboratories, Inc." MUS MUSCULUS SKIN 1
g/50mL "Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histami
ne Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells,
Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
ON DRUG RABBIT HAIR AND EPITHELIA oryctolagus cuniculus hair and o
ryctolagus cuniculus skin "INJECTION, SOLUTION" PERCUTANEOUS; SUBCUTANEO
US 19671207 BLA BLA101376 "Allergy Laboratories, I
nc." ORYCTOLAGUS CUNICULUS HAIR; ORYCTOLAGUS CUNICULUS SKIN .5; .5 g/20mL;
g/20mL "Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histami
hemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptid
es [Chemical/Ingredient],Non-Standardized Animal Skin Allergenic Extract [EPC],I
tion [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient]
"
ON DRUG FIRE ANT solenopsis invicta "INJECTION, SOLUTION"
"Allergy Laboratories, Inc." SOLENOPSIS INVICTA 1 g/20mL "Non-Sta
ndardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE]
,Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chem
ical/Ingredient],Ant Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient
]"
ON DRUG AMERICAN COCKROACH periplaneta americana "INJECTION, SOLU
6 "Allergy Laboratories, Inc." PERIPLANETA AMERICANA 1 g/20mL
"Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [P
E],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Ch
ON DRUG GERMAN COCKROACH blatella germanica "INJECTION, SOLU
6 "Allergy Laboratories, Inc." BLATELLA GERMANICA 1 g/20mL
ON DRUG HOUSEFLY FOR DIAGNOSTIC USE ONLY musca domestica "INJECTI
BLA101376 "Allergy Laboratories, Inc." MUSCA DOMESTICA 1 g/50mL
ON DRUG MOSQUITO FOR DIAGNOSTIC USE ONLY aedes taeniorhynchus
BLA BLA101376 "Allergy Laboratories, Inc." AEDES TAENIORHYNCHUS
1 g/20mL "Non-Standardized Insect Allergenic Extract [EPC],Increased Hist
amine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Ins
ect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
54575-325_c268f64e-7114-4227-a030-0fe9f4def162 54575-325 HUMAN PRESCRIPTI
ON DRUG STANDARDIZED MITE D FARINAE Dermatophagoides farinae
BLA BLA101377 "Allergy Laboratories, Inc." DERMATOPHAGOIDES FARINAE
54575-326_c268f64e-7114-4227-a030-0fe9f4def162 54575-326 HUMAN PRESCRIPTI
ON DRUG STANDARDIZED MITE D PTERONYSSINUS Dermatophagoides pterony
ssinus "INJECTION, SOLUTION" PERCUTANEOUS; SUBCUTANEOUS 19911211
BLA BLA101378 "Allergy Laboratories, Inc." DERMATOPHAGOIDES PTERONY
SSINUS 10000 [AU]/mL "Standardized Insect Allergenic Extract [EPC],Increased
,Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingr
ON DRUG ALMOND almond "INJECTION, SOLUTION" PERCUTANEOUS; SUBCUTANEO
nc." ALMOND 1 g/20mL "Non-Standardized Food Allergenic Extract [EPC],
/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingre
dient]"
ON DRUG APPLE apple "INJECTION, SOLUTION" PERCUTANEOUS; SUBCUTANEO
nc." APPLE 1 g/20mL "Allergens [Chemical/Ingredient],Dietary Protein
s [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient],Non-Standardized Fo
od Allergenic Extract [EPC],Increased Histamine Release [PE]"
ON DRUG APRICOT apricot "INJECTION, SOLUTION" PERCUTANEOUS; SUBCUTANEO
nc." APRICOT 1 g/20mL "Non-Standardized Food Allergenic Extract [EPC],
Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Dietary Protein
s [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient]"
ON DRUG AVOCADO avocado "INJECTION, SOLUTION" PERCUTANEOUS; SUBCUTANEO
nc." AVOCADO 1 g/20mL "Non-Standardized Food Allergenic Extract [EPC],
redient]"
ON DRUG BANANA banana "INJECTION, SOLUTION" PERCUTANEOUS; SUBCUTANEO
nc." BANANA 1 g/20mL "Non-Standardized Food Allergenic Extract [EPC],
redient]"
ON DRUG BARLEY FOOD barley "INJECTION, SOLUTION" PERCUTANEOUS; SU
ories, Inc." BARLEY 1 g/20mL "Non-Standardized Food Allergenic Extrac
ical/Ingredient]"
ON DRUG BASIL basil "INJECTION, SOLUTION" PERCUTANEOUS; SUBCUTANEO
nc." BASIL 1 g/20mL "Non-Standardized Plant Allergenic Extract [EPC]
,Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE]
,Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [C
hemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemica
l/Ingredient]"
ON DRUG BLACK BASS largemouth bass "INJECTION, SOLUTION" PERCUTAN
Laboratories, Inc." LARGEMOUTH BASS 1 g/20mL "Non-Standardized Food A
[PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish
Proteins, Dietary [Chemical/Ingredient]"
ON DRUG LIMA BEAN lima bean "INJECTION, SOLUTION" PERCUTAN
Laboratories, Inc." LIMA BEAN 1 g/20mL "Non-Standardized Food A
ON DRUG NAVY BEAN kidney bean "INJECTION, SOLUTION" PERCUTAN
Laboratories, Inc." KIDNEY BEAN 1 g/20mL "Non-Standardized Plant
Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increase
ent],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient]
,Vegetable Proteins [Chemical/Ingredient]"
ON DRUG PINTO BEAN kidney bean "INJECTION, SOLUTION" PERCUTAN
ON DRUG RED KIDNEY BEAN kidney bean "INJECTION, SOLUTION" PERCUTAN
ON DRUG SOYBEAN soybean "INJECTION, SOLUTION" PERCUTANEOUS; SUBCUTANEO
nc." SOYBEAN 1 g/20mL "Non-Standardized Food Allergenic Extract [EPC],
/Ingredient]"
ON DRUG GREEN STRING BEAN string bean "INJECTION, SOLUTION"
"Allergy Laboratories, Inc." STRING BEAN 1 g/20mL "Non-Standardize
d Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated I
mmunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredie
ON DRUG BEEF beef "INJECTION, SOLUTION" PERCUTANEOUS; SUBCUTANEO
nc." BEEF 1 g/20mL "Non-Standardized Food Allergenic Extract [EPC],
edient]"
ON DRUG BLACKBERRY blackberry "INJECTION, SOLUTION" PERCUTAN
Laboratories, Inc." BLACKBERRY 1 g/20mL
ON DRUG BLUEBERRY blue ridge blueberry "INJECTION, SOLUTION"
"Allergy Laboratories, Inc." BLUE RIDGE BLUEBERRY 1 g/20mL
ON DRUG BROCCOLI broccoli "INJECTION, SOLUTION" PERCUTAN
Laboratories, Inc." BROCCOLI 1 g/20mL "Non-Standardized Food A
[PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vege
table Proteins [Chemical/Ingredient]"
ON DRUG BRUSSEL SPROUTS brussels sprout "INJECTION, SOLUTION" PERCUTAN
Laboratories, Inc." BRUSSELS SPROUT 1 g/20mL "Non-Standardized Plant
ON DRUG BUCKWHEAT buckwheat "INJECTION, SOLUTION" PERCUTAN
Laboratories, Inc." BUCKWHEAT 1 g/20mL "Non-Standardized Food A
[PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grai
n Proteins [Chemical/Ingredient]"
ON DRUG CABBAGE cabbage "INJECTION, SOLUTION" PERCUTANEOUS; SUBCUTANEO
nc." CABBAGE 1 g/20mL "Non-Standardized Food Allergenic Extract [EPC],
/Ingredient]"
ON DRUG CANTALOUPE cantaloupe "INJECTION, SOLUTION" PERCUTAN
Laboratories, Inc." CANTALOUPE 1 g/20mL "Non-Standardized Food A
[PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Frui
ON DRUG CARROT carrot "INJECTION, SOLUTION" PERCUTANEOUS; SUBCUTANEO
nc." CARROT 1 g/20mL "Non-Standardized Food Allergenic Extract [EPC],
/Ingredient]"
ON DRUG CASHEW NUT cashew "INJECTION, SOLUTION" PERCUTANEOUS; SU
ories, Inc." CASHEW 1 g/20mL "Non-Standardized Food Allergenic Extrac
al/Ingredient]"
ON DRUG CATFISH catfish "INJECTION, SOLUTION" PERCUTANEOUS; SUBCUTANEO
nc." CATFISH 1 g/20mL
ON DRUG CAULIFLOWER cauliflower "INJECTION, SOLUTION" PERCUTAN
Laboratories, Inc." CAULIFLOWER 1 g/20mL "Non-Standardized Plant
ON DRUG CELERY celery "INJECTION, SOLUTION" PERCUTANEOUS; SUBCUTANEO
nc." CELERY 1 g/20mL "Non-Standardized Food Allergenic Extract [EPC],
/Ingredient]"
ON DRUG CHERRY FOOD cherry "INJECTION, SOLUTION" PERCUTANEOUS; SU
ories, Inc." CHERRY 1 g/20mL "Non-Standardized Food Allergenic Extrac
ical/Ingredient]"
ON DRUG CHICKEN FOOD chicken "INJECTION, SOLUTION" PERCUTANEOUS; SU
ories, Inc." CHICKEN 1 g/20mL "Non-Standardized Food Allergenic Extrac
Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Ch
emical/Ingredient]"
ON DRUG CINNAMON cinnamon "INJECTION, SOLUTION" PERCUTAN
Laboratories, Inc." CINNAMON 1 g/20mL "Non-Standardized Food A
[PE],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient]
ON DRUG CLAM quahog "INJECTION, SOLUTION" PERCUTANEOUS; SUBCUTANEO
nc." QUAHOG 1 g/20mL "Non-Standardized Food Allergenic Extract [EPC],
/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical
/Ingredient]"
ON DRUG CACAO BEAN cocoa "INJECTION, SOLUTION" PERCUTANEOUS; SU
ories, Inc." COCOA 1 g/20mL "Non-Standardized Food Allergenic Extrac
Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chem
ical/Ingredient]"
ON DRUG COCONUT coconut "INJECTION, SOLUTION" PERCUTANEOUS; SUBCUTANEO
nc." COCONUT 1 g/20mL "Non-Standardized Food Allergenic Extract [EPC],
redient]"
ON DRUG CODFISH cod "INJECTION, SOLUTION" PERCUTANEOUS; SUBCUTANEO
nc." COD 1 g/20mL "Non-Standardized Food Allergenic Extract [EPC],
/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chem
ical/Ingredient]"
ON DRUG COFFEE FOR DIAGNOSTIC USE ONLY coffee bean "INJECTION, SOLU
2 "Allergy Laboratories, Inc." COFFEE BEAN 1 g/20mL "Non-Sta
ndardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-me
diated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/
Ingredient],Plant Proteins [Chemical/Ingredient]"
ON DRUG CORN FOOD corn "INJECTION, SOLUTION" PERCUTANEOUS; SU
ories, Inc." CORN 1 g/20mL "Non-Standardized Food Allergenic Extrac
ical/Ingredient]"
ON DRUG CRAB MEAT blue crab "INJECTION, SOLUTION" PERCUTAN
Laboratories, Inc." BLUE CRAB 1 g/20mL "Non-Standardized Food A
[PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shel
lfish Proteins [Chemical/Ingredient]"
ON DRUG CRANBERRY cranberry "INJECTION, SOLUTION" PERCUTAN
Laboratories, Inc." CRANBERRY 1 g/20mL "Non-Standardized Food A
llergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increase
,Fruit Proteins [Chemical/Ingredient]"
ON DRUG CUCUMBER cucumber "INJECTION, SOLUTION" PERCUTAN
Laboratories, Inc." CUCUMBER 1 g/20mL "Non-Standardized Food A
ON DRUG DATE date "INJECTION, SOLUTION" PERCUTANEOUS; SUBCUTANEO
nc." DATE 1 g/20mL "Non-Standardized Food Allergenic Extract [EPC],
Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE]
hemical/Ingredient],Plant Proteins [Chemical/Ingredient],Fruit Proteins [Chemica
l/Ingredient]"
ON DRUG DILL SEED dill "INJECTION, SOLUTION" PERCUTANEOUS; SU
ories, Inc." DILL 1 g/20mL "Non-Standardized Plant Allergenic Extra
ase [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Pro
teins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives
ON DRUG EGG WHITE egg white "INJECTION, SOLUTION" PERCUTAN
Laboratories, Inc." EGG WHITE 1 g/20mL "Cell-mediated Immunity
[PE],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release
[PE],Allergens [Chemical/Ingredient],Egg Proteins, Dietary [Chemical/Ingredient]
,Dietary Proteins [Chemical/Ingredient]"
ON DRUG WHOLE EGG egg "INJECTION, SOLUTION" PERCUTANEOUS; SU
ories, Inc." EGG 1 g/20mL "Non-Standardized Food Allergenic Extrac
Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Egg Proteins, Dietar
y [Chemical/Ingredient]"
ON DRUG EGG YOLK egg yolk "INJECTION, SOLUTION" PERCUTAN
Laboratories, Inc." EGG YOLK 1 g/20mL "Non-Standardized Food A
[PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Egg
ON DRUG FLOUNDER flounder "INJECTION, SOLUTION" PERCUTAN
Laboratories, Inc." FLOUNDER 1 g/20mL "Non-Standardized Food A
ON DRUG GARLIC garlic "INJECTION, SOLUTION" PERCUTANEOUS; SUBCUTANEO
nc." GARLIC 1 g/20mL "Non-Standardized Food Allergenic Extract [EPC],
redient]"
ON DRUG GINGER ginger "INJECTION, SOLUTION" PERCUTANEOUS; SUBCUTANEO
nc." GINGER 1 g/20mL "Non-Standardized Plant Allergenic Extract [EPC]
l/Ingredient]"
ON DRUG GRAPE concord grape "INJECTION, SOLUTION" PERCUTANEOUS; SU
ories, Inc." CONCORD GRAPE 1 g/20mL "Non-Standardized Food Allergeni
c Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histam
tary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Fruit P
roteins [Chemical/Ingredient]"
ON DRUG GRAPEFRUIT grapefruit "INJECTION, SOLUTION" PERCUTAN
Laboratories, Inc." GRAPEFRUIT 1 g/20mL "Non-Standardized Food A
ON DRUG HADDOCK haddock "INJECTION, SOLUTION" PERCUTANEOUS; SUBCUTANEO
nc." HADDOCK 1 g/20mL "Non-Standardized Food Allergenic Extract [EPC],
ical/Ingredient]"
ON DRUG HALIBUT pacific halibut "INJECTION, SOLUTION" PERCUTANEOUS; SU
ories, Inc." PACIFIC HALIBUT 1 g/20mL "Non-Standardized Food Allergeni
ergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Protein
s, Dietary [Chemical/Ingredient]"
ON DRUG HORSERADISH horseradish "INJECTION, SOLUTION" PERCUTAN
Laboratories, Inc." HORSERADISH 1 g/20mL "Non-Standardized Food A
,Food Additives [Chemical/Ingredient]"
ON DRUG LEMON lemon "INJECTION, SOLUTION" PERCUTANEOUS; SUBCUTANEO
nc." LEMON 1 g/20mL "Non-Standardized Food Allergenic Extract [EPC],
redient]"
ON DRUG LETTUCE lettuce "INJECTION, SOLUTION" PERCUTANEOUS; SUBCUTANEO
nc." LETTUCE 1 g/20mL "Non-Standardized Food Allergenic Extract [EPC],
/Ingredient]"
ON DRUG LIME "lime, citrus" "INJECTION, SOLUTION" PERCUTANEOUS; SU
ories, Inc." LIME (CITRUS) 1 g/20mL "Non-Standardized Food Allergeni
ergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Protei
ON DRUG BARLEY MALT barley malt "INJECTION, SOLUTION" PERCUTAN
Laboratories, Inc." BARLEY MALT 1 g/20mL "Non-Standardized Food A
,Grain Proteins [Chemical/Ingredient]"
ON DRUG COW MILK cow milk "INJECTION, SOLUTION" PERCUTAN
Laboratories, Inc." COW MILK 1 g/20mL "Non-Standardized Food A
[PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Milk
Proteins [Chemical/Ingredient]"
ON DRUG MUSHROOM FOOD cultivated mushroom "INJECTION, SOLUTION"
"Allergy Laboratories, Inc." CULTIVATED MUSHROOM 1 g/20mL "Non-Sta
Ingredient],Fungal Proteins [Chemical/Ingredient]"
ON DRUG MUSTARD SEED mustard seed "INJECTION, SOLUTION" PERCUTAN
Laboratories, Inc." MUSTARD SEED 1 g/20mL "Non-Standardized Plant
E],Allergens [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Dietary
Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage
ON DRUG OATS FOOD oat "INJECTION, SOLUTION" PERCUTANEOUS; SU
ories, Inc." OAT 1 g/20mL "Non-Standardized Food Allergenic Extrac
ical/Ingredient]"
ON DRUG GREEN OLIVE green olive "INJECTION, SOLUTION" PERCUTAN
Laboratories, Inc." GREEN OLIVE 1 g/20mL "Non-Standardized Food A
ent],Plant Proteins [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient]
ON DRUG ONION onion "INJECTION, SOLUTION" PERCUTANEOUS; SUBCUTANEO
nc." ONION 1 g/20mL "Non-Standardized Food Allergenic Extract [EPC],
/Ingredient]"
ON DRUG ORANGE FOOD orange "INJECTION, SOLUTION" PERCUTANEOUS; SU
ories, Inc." ORANGE 1 g/20mL "Non-Standardized Food Allergenic Extrac
ical/Ingredient]"
ON DRUG OREGANO oregano "INJECTION, SOLUTION" PERCUTANEOUS; SUBCUTANEO
nc." OREGANO 1 g/20mL "Non-Standardized Food Allergenic Extract [EPC],
/Ingredient],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ing
redient]"
ON DRUG PAPAYA papaya "INJECTION, SOLUTION" PERCUTANEOUS; SUBCUTANEO
nc." PAPAYA 1 g/20mL "Non-Standardized Food Allergenic Extract [EPC],
redient]"
ON DRUG PARSLEY parsley "INJECTION, SOLUTION" PERCUTANEOUS; SUBCUTANEO
nc." PARSLEY 1 g/20mL "Non-Standardized Food Allergenic Extract [EPC],
/Ingredient]"
ON DRUG BLACKEYED PEA black-eyed pea "INJECTION, SOLUTION" PERCUTAN
Laboratories, Inc." BLACK-EYED PEA 1 g/20mL "Non-Standardized Food A
[PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient]"
ON DRUG GREEN PEA pea "INJECTION, SOLUTION" PERCUTANEOUS; SU
ories, Inc." PEA 1 g/20mL "Non-Standardized Food Allergenic Extrac
ON DRUG PEACH peach "INJECTION, SOLUTION" PERCUTANEOUS; SUBCUTANEO
nc." PEACH 1 g/20mL "Non-Standardized Food Allergenic Extract [EPC],
redient]"
ON DRUG PEANUT FOOD peanut "INJECTION, SOLUTION" PERCUTANEOUS; SU
ories, Inc." PEANUT 1 g/20mL "Non-Standardized Food Allergenic Extrac
al/Ingredient]"
ON DRUG PEAR pear "INJECTION, SOLUTION" PERCUTANEOUS; SUBCUTANEO
nc." PEAR 1 g/20mL "Non-Standardized Food Allergenic Extract [EPC],
redient]"
ON DRUG PECAN FOOD pecan "INJECTION, SOLUTION" PERCUTANEOUS; SU
ories, Inc." PECAN 1 g/20mL "Non-Standardized Food Allergenic Extrac
al/Ingredient]"
ON DRUG BLACK PEPPER black pepper "INJECTION, SOLUTION" PERCUTAN
Laboratories, Inc." BLACK PEPPER 1 g/20mL "Non-Standardized Food A
ON DRUG GREEN PEPPER green bell pepper "INJECTION, SOLUTION"
"Allergy Laboratories, Inc." GREEN BELL PEPPER 1 g/20mL "Non-Sta
Ingredient],Vegetable Proteins [Chemical/Ingredient]"
ON DRUG PERCH perch "INJECTION, SOLUTION" PERCUTANEOUS; SUBCUTANEO
nc." PERCH 1 g/20mL "Non-Standardized Food Allergenic Extract [EPC],
ical/Ingredient]"
ON DRUG PIMENTO red bell pepper "INJECTION, SOLUTION" PERCUTANEOUS; SU
ories, Inc." RED BELL PEPPER 1 g/20mL "Non-Standardized Food Allergeni
ON DRUG PINEAPPLE pineapple "INJECTION, SOLUTION" PERCUTAN
Laboratories, Inc." PINEAPPLE 1 g/20mL "Non-Standardized Food A
ON DRUG POPPY SEED poppy seed "INJECTION, SOLUTION" PERCUTAN
Laboratories, Inc." POPPY SEED 1 g/20mL "Non-Standardized Plant
,Seed Storage Proteins [Chemical/Ingredient]"
ON DRUG PORK pork "INJECTION, SOLUTION" PERCUTANEOUS; SUBCUTANEO
nc." PORK 1 g/20mL "Non-Standardized Food Allergenic Extract [EPC],
edient]"
ON DRUG SWEET POTATO sweet potato "INJECTION, SOLUTION" PERCUTAN
Laboratories, Inc." SWEET POTATO 1 g/20mL "Non-Standardized Food A
ON DRUG WHITE POTATO potato "INJECTION, SOLUTION" PERCUTANEOUS; SU
ories, Inc." POTATO 1 g/20mL "Non-Standardized Food Allergenic Extrac
ON DRUG RADISH radish "INJECTION, SOLUTION" PERCUTANEOUS; SUBCUTANEO
nc." RADISH 1 g/20mL "Non-Standardized Food Allergenic Extract [EPC],
/Ingredient]"
ON DRUG RHUBARB rhubarb "INJECTION, SOLUTION" PERCUTANEOUS; SUBCUTANEO
nc." RHUBARB 1 g/20mL "Non-Standardized Plant Allergenic Extract [EPC]
ON DRUG RICE FOOD rice "INJECTION, SOLUTION" PERCUTANEOUS; SU
ories, Inc." RICE 1 g/20mL "Non-Standardized Food Allergenic Extrac
ical/Ingredient]"
ON DRUG RYE FOOD rye "INJECTION, SOLUTION" PERCUTANEOUS; SU
ories, Inc." RYE 1 g/20mL "Non-Standardized Food Allergenic Extrac
ical/Ingredient]"
ON DRUG SAGE FOOD sage "INJECTION, SOLUTION" PERCUTANEOUS; SU
ories, Inc." SAGE 1 g/20mL "Non-Standardized Plant Allergenic Extra
teins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient]"
ON DRUG PACIFIC SALMON pink salmon "INJECTION, SOLUTION" PERCUTAN
Laboratories, Inc." PINK SALMON 1 g/20mL
ON DRUG SCALLOP scallop "INJECTION, SOLUTION" PERCUTANEOUS; SUBCUTANEO
nc." SCALLOP 1 g/20mL "Non-Standardized Food Allergenic Extract [EPC],
/Ingredient]"
ON DRUG SESAME SEED sesame seed "INJECTION, SOLUTION" PERCUTAN
Laboratories, Inc." SESAME SEED 1 g/20mL "Non-Standardized Food A
[PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Seed
Storage Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient]"
ON DRUG SHRIMP shrimp "INJECTION, SOLUTION" PERCUTANEOUS; SUBCUTANEO
nc." SHRIMP 1 g/20mL "Non-Standardized Food Allergenic Extract [EPC],
/Ingredient]"
ON DRUG SPEARMINT spearmint "INJECTION, SOLUTION" PERCUTAN
Laboratories, Inc." SPEARMINT 1 g/20mL "Non-Standardized Food A
[PE],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient],Dietar
y Proteins [Chemical/Ingredient]"
ON DRUG SPINACH spinach "INJECTION, SOLUTION" PERCUTANEOUS; SUBCUTANEO
nc." SPINACH 1 g/20mL "Non-Standardized Food Allergenic Extract [EPC],
/Ingredient]"
ON DRUG YELLOW SQUASH squash "INJECTION, SOLUTION" PERCUTANEOUS; SU
ories, Inc." SQUASH 1 g/20mL "Non-Standardized Food Allergenic Extrac
ON DRUG STRAWBERRY strawberry "INJECTION, SOLUTION" PERCUTAN
Laboratories, Inc." STRAWBERRY 1 g/20mL "Non-Standardized Food A
ON DRUG SUNFLOWER SEED sunflower seed "INJECTION, SOLUTION" PERCUTAN
Laboratories, Inc." SUNFLOWER SEED 1 g/20mL "Non-Standardized Food A
ON DRUG THYME thyme "INJECTION, SOLUTION" PERCUTANEOUS; SUBCUTANEO
nc." THYME 1 g/20mL "Non-Standardized Food Allergenic Extract [EPC],
Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Produ
ction [PE],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingre
ON DRUG TOMATO tomato "INJECTION, SOLUTION" PERCUTANEOUS; SUBCUTANEO
nc." TOMATO 1 g/20mL "Non-Standardized Food Allergenic Extract [EPC],
/Ingredient]"
ON DRUG LAKE TROUT trout "INJECTION, SOLUTION" PERCUTANEOUS; SU
ories, Inc." TROUT 1 g/20mL "Non-Standardized Food Allergenic Extrac
ON DRUG TUNA tuna "INJECTION, SOLUTION" PERCUTANEOUS; SUBCUTANEO
nc." TUNA 1 g/20mL "Non-Standardized Food Allergenic Extract [EPC],
ical/Ingredient]"
ON DRUG TURKEY FOOD turkey "INJECTION, SOLUTION" PERCUTANEOUS; SU
ories, Inc." TURKEY 1 g/20mL "Non-Standardized Food Allergenic Extrac
Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Ch
emical/Ingredient]"
ON DRUG VANILLA vanilla "INJECTION, SOLUTION" PERCUTANEOUS; SUBCUTANEO
nc." VANILLA 1 g/20mL "Non-Standardized Food Allergenic Extract [EPC],
Increased Histamine Release [PE],Cell-mediated Immunity [PE],Food Additives [Che
mical/Ingredient],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ing
redient]"
ON DRUG BLACK WALNUT FOOD black walnut "INJECTION, SOLUTION"
"Allergy Laboratories, Inc." BLACK WALNUT 1 g/20mL "Non-Standardize
nt],Nut Proteins [Chemical/Ingredient]"
ON DRUG ENGLISH WALNUT FOOD english walnut "INJECTION, SOLUTION"
"Allergy Laboratories, Inc." ENGLISH WALNUT 1 g/20mL "Non-Standardize
nt],Nut Proteins [Chemical/Ingredient]"
ON DRUG WATERMELON watermelon "INJECTION, SOLUTION" PERCUTAN
Laboratories, Inc." WATERMELON 1 g/20mL "Non-Standardized Food A
ON DRUG WHOLE WHEAT FOOD wheat "INJECTION, SOLUTION" PERCUTAN
Laboratories, Inc." WHEAT 1 g/20mL "Non-Standardized Food Allergeni
ergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Protei
ON DRUG PEPPERMINT peppermint "INJECTION, SOLUTION" PERCUTAN
Laboratories, Inc." PEPPERMINT 1 g/20mL "Non-Standardized Plant
,Food Additives [Chemical/Ingredient]"
ON DRUG ACACIA POLLEN acacia "INJECTION, SOLUTION" PERCUTANEOUS; SU
ories, Inc." ACACIA 1 g/20mL "Non-Standardized Plant Allergenic Extra
IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ing
redient]"
ON DRUG RED ALDER POLLEN alnus rubra pollen "INJECTION, SOLU
6 "Allergy Laboratories, Inc." ALNUS RUBRA POLLEN 1 g/20mL
ON DRUG SMOOTH ALDER POLLEN alnus incana subsp. rugosa pollen
BLA BLA101376 "Allergy Laboratories, Inc." ALNUS INCANA SUBSP. RUGO
SA POLLEN 1 g/20mL "Non-Standardized Pollen Allergenic Extract [EPC
ON DRUG ARIZONA ASH POLLEN fraxinus velutina pollen "INJECTI
BLA101376 "Allergy Laboratories, Inc." FRAXINUS VELUTINA POLLEN
ON DRUG GREEN RED ASH POLLEN fraxinus pennsylvanica pollen "INJECTI
BLA101376 "Allergy Laboratories, Inc." FRAXINUS PENNSYLVANICA POLLEN
ON DRUG WHITE ASH POLLEN fraxinus americana pollen "INJECTI
BLA101376 "Allergy Laboratories, Inc." FRAXINUS AMERICANA POLLEN
ON DRUG "ASH MIX, GREEN/WHITE POLLEN" fraxinus americana pollen and fr
axinus pennsylvanica pollen "INJECTION, SOLUTION" PERCUTANEOUS; SUBCUTANEO
nc." FRAXINUS AMERICANA POLLEN; FRAXINUS PENNSYLVANICA POLLEN .5; .5
g/20mL; g/20mL "Non-Standardized Pollen Allergenic Extract [EPC],Increased Hist
emical/Ingredient]"
ON DRUG QUAKING ASPEN POLLEN populus tremuloides pollen "INJECTI
BLA101376 "Allergy Laboratories, Inc." POPULUS TREMULOIDES POLLEN
ON DRUG BAYBERRY POLLEN morella cerifera pollen "INJECTION, SOLUTION"
"Allergy Laboratories, Inc." MORELLA CERIFERA POLLEN 1 g/20mL "Non-Sta
ON DRUG AMERICAN BEECH POLLEN fagus grandifolia pollen "INJECTI
BLA101376 "Allergy Laboratories, Inc." FAGUS GRANDIFOLIA POLLEN
ON DRUG RIVER BIRCH POLLEN betula nigra pollen "INJECTION, SOLU
6 "Allergy Laboratories, Inc." BETULA NIGRA POLLEN 1 g/20mL
ON DRUG "BIRCH MIX, RIVER/PAPER/SWEET/WHITE POLLEN" betula nigra pol
len and betula papyrifera pollen and betula lenta pollen and betula populifolia
BLA BLA101376 "Allergy Laboratories, Inc." BETULA LENTA POLLEN; BET
ULA NIGRA POLLEN; BETULA PAPYRIFERA POLLEN; BETULA POPULIFOLIA POLLEN .25; .25
; .25; .25 g/20mL; g/20mL; g/20mL; g/20mL "Non-Standardized Pollen Allerge
gredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine R
elease [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Ch
emical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Aller
,Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/
ON DRUG BOX ELDER POLLEN acer negundo pollen "INJECTION, SOLU
6 "Allergy Laboratories, Inc." ACER NEGUNDO POLLEN 1 g/20mL
ON DRUG MOUNTAIN CEDAR POLLEN juniperus ashei pollen "INJECTION, SOLU
6 "Allergy Laboratories, Inc." JUNIPERUS ASHEI POLLEN 1 g/20mL
ON DRUG PINCHOT CEDAR POLLEN juniperus pinchotii pollen "INJECTI
BLA101376 "Allergy Laboratories, Inc." JUNIPERUS PINCHOTII POLLEN
ON DRUG RED CEDAR POLLEN juniperus virginiana pollen "INJECTI
BLA101376 "Allergy Laboratories, Inc." JUNIPERUS VIRGINIANA POLLEN
ON DRUG EASTERN COTTONWOOD POLLEN populus deltoides pollen
BLA BLA101376 "Allergy Laboratories, Inc." POPULUS DELTOIDES POLLEN
ON DRUG WESTERN COTTONWOOD POLLEN populus deltoides subsp. monilif
era pollen "INJECTION, SOLUTION" PERCUTANEOUS; SUBCUTANEOUS 19671207
BLA BLA101376 "Allergy Laboratories, Inc." POPULUS DELTOIDES SUBSP.
MONILIFERA POLLEN 1 g/20mL "Non-Standardized Pollen Allergenic Extr
]"
ON DRUG "COTTONWOOD MIX, EASTERN/WESTERN POLLEN" populus deltoide
s subsp. monilifera pollen and populus deltoides pollen "INJECTION, SOLUTION"
"Allergy Laboratories, Inc." POPULUS DELTOIDES POLLEN; POPULUS DELTOIDES SUBS
P. MONILIFERA POLLEN .5; .5 g/20mL; g/20mL "Non-Standardized Pollen Allerge
ON DRUG ARIZONA CYPRESS POLLEN cupressus arizonica pollen "INJECTI
BLA101376 "Allergy Laboratories, Inc." CUPRESSUS ARIZONICA POLLEN
ON DRUG BALD CYPRESS POLLEN taxodium distichum pollen "INJECTI
BLA101376 "Allergy Laboratories, Inc." TAXODIUM DISTICHUM POLLEN
ON DRUG AMERICAN ELM POLLEN ulmus americana pollen "INJECTION, SOLU
6 "Allergy Laboratories, Inc." ULMUS AMERICANA POLLEN 1 g/20mL
ON DRUG CEDAR FALL BLOOMING ELM POLLEN ulmus crassifolia pollen
BLA BLA101376 "Allergy Laboratories, Inc." ULMUS CRASSIFOLIA POLLEN
ON DRUG CHINESE SIBERIAN ELM POLLEN ulmus pumila pollen "INJECTI
BLA101376 "Allergy Laboratories, Inc." ULMUS PUMILA POLLEN 1
ON DRUG "ELM MIX, AMERICAN/CHINESE/SLIPPERY POLLEN" ulmus pumila pol
len and ulmus americana pollen and ulmus rubra pollen "INJECTION, SOLUTION"
"Allergy Laboratories, Inc." ULMUS AMERICANA POLLEN; ULMUS PUMILA POLLEN; ULM
US RUBRA POLLEN .33; .33; .34 g/20mL; g/20mL; g/20mL "Non-Standardized Pollen
llen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Poll
en Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immun
ity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [C
hemical/Ingredient]"
ON DRUG EUCALYPTUS BLUE GUM POLLEN eucalyptus globulus pollen
BLA BLA101376 "Allergy Laboratories, Inc." EUCALYPTUS GLOBULUS POLL
EN 1 g/20mL "Non-Standardized Pollen Allergenic Extract [EPC],Increa
ON DRUG DOUGLAS FIR POLLEN pseudotsuga menziesii pollen "INJECTI
BLA101376 "Allergy Laboratories, Inc." PSEUDOTSUGA MENZIESII POLLEN
ON DRUG SWEETGUM POLLEN liquidambar styraciflua pollen "INJECTION, SOLU
6 "Allergy Laboratories, Inc." LIQUIDAMBAR STYRACIFLUA POLLEN 1
ON DRUG HACKBERRY POLLEN celtis occidentalis pollen "INJECTI
BLA101376 "Allergy Laboratories, Inc." CELTIS OCCIDENTALIS POLLEN
ON DRUG SHAGBARK HICKORY POLLEN carya ovata pollen "INJECTION, SOLU
6 "Allergy Laboratories, Inc." CARYA OVATA POLLEN 1 g/20mL
ON DRUG WHITE HICKORY POLLEN carya tomentosa pollen "INJECTION, SOLU
6 "Allergy Laboratories, Inc." CARYA TOMENTOSA POLLEN 1 g/20mL
ON DRUG "HICKORY MIX, PIGNUT/SHAGBARK/SHELLBARK/WHITE POLLEN" carya to
mentosa pollen and carya laciniosa pollen and carya ovata pollen and carya glabr
a pollen "INJECTION, SOLUTION" PERCUTANEOUS; SUBCUTANEOUS 19671207
BLA BLA101376 "Allergy Laboratories, Inc." CARYA GLABRA POLLEN; CAR
YA LACINIOSA POLLEN; CARYA OVATA POLLEN; CARYA TOMENTOSA POLLEN .25; .25; .25; .
25 g/20mL; g/20mL; g/20mL; g/20mL "Non-Standardized Pollen Allergenic Extr
],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [
PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/I
ngredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Ex
ON DRUG ONE SEED JUNIPER POLLEN juniperus monosperma pollen "INJECTI
BLA101376 "Allergy Laboratories, Inc." JUNIPERUS MONOSPERMA POLLEN
ON DRUG ROCKY MOUNTAIN JUNIPER POLLEN juniperus scopulorum pollen
BLA BLA101376 "Allergy Laboratories, Inc." JUNIPERUS SCOPULORUM POL
ON DRUG WHITE GRAY BIRCH POLLEN betula populifolia pollen "INJECTI
BLA101376 "Allergy Laboratories, Inc." BETULA POPULIFOLIA POLLEN
ON DRUG SUGAR HARD MAPLE POLLEN acer saccharum pollen "INJECTION, SOLU
6 "Allergy Laboratories, Inc." ACER SACCHARUM POLLEN 1 g/20mL
ON DRUG "MAPLE MIX, RED/SILVER/SUGAR POLLEN" acer saccharum pollen an
d acer saccharinum pollen and acer rubrum pollen "INJECTION, SOLUTION"
"Allergy Laboratories, Inc." ACER RUBRUM POLLEN; ACER SACCHARINUM POLLEN; ACE
R SACCHARUM POLLEN .34; .33; .33 g/20mL; g/20mL; g/20mL "Non-Standardize
[PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardi
zed Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediat
ed Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Alle
ON DRUG MESQUITE POLLEN prosopis juliflora pollen "INJECTION, SOLU
6 "Allergy Laboratories, Inc." PROSOPIS JULIFLORA POLLEN 1
ON DRUG PAPER MULBERRY POLLEN broussonetia papyrifera pollen "INJECTI
BLA101376 "Allergy Laboratories, Inc." BROUSSONETIA PAPYRIFERA POLLEN
ON DRUG RED MULBERRY POLLEN morus rubra pollen "INJECTION, SOLU
6 "Allergy Laboratories, Inc." MORUS RUBRA POLLEN 1 g/20mL
ON DRUG WHITE MULBERRY POLLEN morus alba pollen "INJECTION, SOLU
6 "Allergy Laboratories, Inc." MORUS ALBA POLLEN 1 g/20mL
ON DRUG BLACK OAK POLLEN quercus velutina pollen "INJECTION, SOLU
6 "Allergy Laboratories, Inc." QUERCUS VELUTINA POLLEN 1 g/20mL
ON DRUG BLACKJACK OAK POLLEN quercus nigra pollen "INJECTION, SOLU
6 "Allergy Laboratories, Inc." QUERCUS NIGRA POLLEN 1 g/20mL
ON DRUG BUR OAK POLLEN quercus macrocarpa pollen "INJECTION, SOLU
6 "Allergy Laboratories, Inc." QUERCUS MACROCARPA POLLEN 1
ON DRUG LIVE OAK POLLEN quercus virginiana pollen "INJECTION, SOLU
6 "Allergy Laboratories, Inc." QUERCUS VIRGINIANA POLLEN 1
ON DRUG "2-OAK MIX, RED/WHITE POLLEN" quercus rubra pollen and quercus
alba pollen "INJECTION, SOLUTION" PERCUTANEOUS; SUBCUTANEOUS 19671207
BLA BLA101376 "Allergy Laboratories, Inc." QUERCUS ALBA POLLEN; QUE
RCUS RUBRA POLLEN .5; .5 g/20mL; g/20mL "Non-Standardized Pollen Allerge
ON DRUG "3-OAK MIX, BLACK/BLACKJACK/POST POLLEN" quercus velutina
pollen and quercus nigra pollen and quercus stellata pollen "INJECTION, SOLU
6 "Allergy Laboratories, Inc." QUERCUS NIGRA POLLEN; QUERCUS STELLATA P
OLLEN; QUERCUS VELUTINA POLLEN .33; .34; .33 g/20mL; g/20mL; g/20mL "Non-Sta
oduction [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-S
tandardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cel
l-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredie
ON DRUG "5-OAK MIX, BLACKJACK/BUR/POST/RED/WHITE POLLEN" quercus
nigra pollen and quercus macrocarpa pollen and quercus stellata pollen and querc
us rubra pollen and quercus alba pollen "INJECTION, SOLUTION" PERCUTANEOUS; SU
ories, Inc." QUERCUS ALBA POLLEN; QUERCUS MACROCARPA POLLEN; QUERCUS NIGRA PO
LLEN; QUERCUS RUBRA POLLEN; QUERCUS STELLATA POLLEN .2; .2; .2; .2; .2
g/20mL; g/20mL; g/20mL; g/20mL; g/20mL "Non-Standardized Pollen Allergenic Extr
/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic
ient]"
ON DRUG POST OAK POLLEN quercus stellata pollen "INJECTION, SOLUTION"
"Allergy Laboratories, Inc." QUERCUS STELLATA POLLEN 1 g/20mL "Non-Sta
ON DRUG QUEEN PALM POLLEN syagrus romanzoffiana pollen "INJECTI
BLA101376 "Allergy Laboratories, Inc." SYAGRUS ROMANZOFFIANA POLLEN
ON DRUG EUROPEAN OLIVE POLLEN olea europaea pollen "INJECTION, SOLU
6 "Allergy Laboratories, Inc." OLEA EUROPAEA POLLEN 1 g/20mL
ON DRUG OSAGE ORANGE VAR BOIS DARC POLLEN maclura pomifera pollen
BLA BLA101376 "Allergy Laboratories, Inc." MACLURA POMIFERA POLLEN
ON DRUG DATE PALM POLLEN phoenix dactylifera pollen "INJECTI
BLA101376 "Allergy Laboratories, Inc." PHOENIX DACTYLIFERA POLLEN
ON DRUG PECAN POLLEN carya illinoinensis pollen "INJECTION, SOLU
6 "Allergy Laboratories, Inc." CARYA ILLINOINENSIS POLLEN 1
ON DRUG WHITE PINE POLLEN pinus strobus pollen "INJECTION, SOLU
6 "Allergy Laboratories, Inc." PINUS STROBUS POLLEN 1 g/20mL
ON DRUG "4-PINE MIX, AUSTRIAN/LOBLOLLY/SCOTCH/WHITE POLLEN" pinus st
robus pollen and pinus sylvestris pollen and pinus taeda pollen and pinus nigra
BLA BLA101376 "Allergy Laboratories, Inc." PINUS NIGRA POLLEN; PINU
S STROBUS POLLEN; PINUS SYLVESTRIS POLLEN; PINUS TAEDA POLLEN .25; .25; .25; .
25 g/20mL; g/20mL; g/20mL; g/20mL "Non-Standardized Pollen Allergenic Extr
ON DRUG LOMBARDY POPLAR POLLEN populus nigra pollen "INJECTION, SOLU
6 "Allergy Laboratories, Inc." POPULUS NIGRA POLLEN 1 g/20mL
ON DRUG WHITE POPLAR POLLEN populus alba pollen "INJECTION, SOLU
6 "Allergy Laboratories, Inc." POPULUS ALBA POLLEN 1 g/20mL
ON DRUG PRIVET POLLEN ligustrum vulgare pollen "INJECTION, SOLU
6 "Allergy Laboratories, Inc." LIGUSTRUM VULGARE POLLEN 1
ON DRUG BLUE SPRUCE POLLEN picea pungens pollen "INJECTION, SOLU
6 "Allergy Laboratories, Inc." PICEA PUNGENS POLLEN 1 g/20mL
ON DRUG UPLAND SUMAC POLLEN rhus glabra pollen "INJECTION, SOLU
6 "Allergy Laboratories, Inc." RHUS GLABRA POLLEN 1 g/20mL
ON DRUG SYCAMORE POLLEN platanus occidentalis pollen "INJECTION, SOLU
6 "Allergy Laboratories, Inc." PLATANUS OCCIDENTALIS POLLEN 1
ON DRUG TREE OF HEAVEN POLLEN ailanthus altissima pollen "INJECTI
BLA101376 "Allergy Laboratories, Inc." AILANTHUS ALTISSIMA POLLEN
ON DRUG BLACK WALNUT POLLEN juglans nigra pollen "INJECTION, SOLU
6 "Allergy Laboratories, Inc." JUGLANS NIGRA POLLEN 1 g/20mL
ON DRUG BLACK WILLOW POLLEN salix nigra pollen "INJECTION, SOLU
6 "Allergy Laboratories, Inc." SALIX NIGRA POLLEN 1 g/20mL
ON DRUG PUSSY WILLOW POLLEN salix discolor pollen "INJECTION, SOLU
6 "Allergy Laboratories, Inc." SALIX DISCOLOR POLLEN 1 g/20mL
ON DRUG BLACK LOCUST POLLEN robinia pseudoacacia pollen "INJECTI
BLA101376 "Allergy Laboratories, Inc." ROBINIA PSEUDOACACIA POLLEN
ON DRUG WHITE OAK POLLEN quercus alba pollen "INJECTION, SOLU
6 "Allergy Laboratories, Inc." QUERCUS ALBA POLLEN 1 g/20mL
49643-003_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-003 NON-STANDARDIZED
ALLERGENIC Cattle Epithelia Cattle Epithelia INJECTIO
N CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA
BLA102212 "Allermed Laboratories, Inc." BOS TAURUS SKIN 1 g/10mL
ALLERGENIC Cotton Linters Cotton Linters INJECTION CUTANEOU
S; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212
"Allermed Laboratories, Inc." COTTON FIBER 1 g/10mL "Non-Standardize
ALLERGENIC Cottonseed Cottonseed INJECTION CUTANEOU
"Allermed Laboratories, Inc." COTTON SEED 1 g/10mL "Non-Standardize
d Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated
Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plan
t Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient]"
ALLERGENIC Dog Hair Dog Hair INJECTION CUTANEOU
"Allermed Laboratories, Inc." CANIS LUPUS FAMILIARIS HAIR 1 g/10mL
"Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Relea
se [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/
Ingredient],Allergens [Chemical/Ingredient]"
ALLERGENIC House Dust House Dust INJECTION CUTANEOU
"Allermed Laboratories, Inc." HOUSE DUST 1 g/50mL "Non-Standardize
d House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-medi
ated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient]
,House Dust [Chemical/Ingredient]"
ALLERGENIC Flaxseed Flaxseed INJECTION CUTANEOU
"Allermed Laboratories, Inc." FLAX SEED 1 g/20mL "Non-Standardize
d Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],
ction [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient
],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredien
t]"
ALLERGENIC Goat Epithelia Goat Epithelia INJECTION CUTANEOU
"Allermed Laboratories, Inc." CAPRA HIRCUS SKIN 1 g/20mL "Non-Sta
ALLERGENIC Guinea Pig Epithelia Guinea Pig Epithelia INJECTIO
BLA102212 "Allermed Laboratories, Inc." CAVIA PORCELLUS SKIN 1
g/20mL "Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histami
ne Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells,
Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
ALLERGENIC Hamster Epithelia Hamster Epithelia INJECTIO
BLA102212 "Allermed Laboratories, Inc." MESOCRICETUS AURATUS SKIN
1 g/20mL "Non-Standardized Animal Skin Allergenic Extract [EPC],Increased
Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE
],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
ALLERGENIC Hog Epithelia Hog Epithelia INJECTION CUTANEOU
"Allermed Laboratories, Inc." SUS SCROFA SKIN 1 g/20mL "Non-Standardize
ALLERGENIC Horse Epithelia Horse Epithelia INJECTION CUTANEOU
"Allermed Laboratories, Inc." EQUUS CABALLUS SKIN 1 g/10mL "Non-Sta
ALLERGENIC Jute Jute INJECTION CUTANEOUS; INTRADERMAL;
SUBCUTANEOUS 19740312 BLA BLA102212 "Allermed Labora
tories, Inc." CORCORUS CAPSULARIS FIBER 1 g/10mL "Non-Standardize
ALLERGENIC Kapok Kapok INJECTION CUTANEOUS; INTRADERMAL;
tories, Inc." CEIBA PENTANDRA FIBER 1 g/10mL "Non-Standardized Plant
ALLERGENIC Karaya Gum Karaya Gum INJECTION CUTANEOU
"Allermed Laboratories, Inc." KARAYA GUM 1 g/100mL "Non-Standardize
mmunity [PE],Increased IgG Production [PE],Dietary Proteins [Chemical/Ingredient
],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
ALLERGENIC Mouse Epithelia Mouse Epithelia INJECTION CUTANEOU
"Allermed Laboratories, Inc." MUS MUSCULUS SKIN 1 g/10mL "Non-Sta
ALLERGENIC Orris Root Orris Root INJECTION CUTANEOU
"Allermed Laboratories, Inc." IRIS GERMANICA VAR. FLORENTINA RHIZOME 1
g/10mL "Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased
IgG Production [PE],Allergens [Chemical/Ingredient],Non-Standardized Plant Aller
genic Extract [EPC],Plant Proteins [Chemical/Ingredient]"
ALLERGENIC Sisal Sisal INJECTION CUTANEOUS; INTRADERMAL;
tories, Inc." AGAVE SISALANA FIBER 1 g/10mL "Non-Standardized Plant
ALLERGENIC Tobacco Leaf Tobacco Leaf INJECTION CUTANEOU
"Allermed Laboratories, Inc." TOBACCO LEAF 1 g/10mL "Non-Standardize
d Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated
Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plan
ALLERGENIC "Cockroach, American" Periplaneta americana INJECTIO
BLA102212 "Allermed Laboratories, Inc." PERIPLANETA AMERICANA 1
g/10mL "Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Re
lease [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Prot
ALLERGENIC "Cockroach, German" Blattella germanica INJECTIO
BLA102212 "Allermed Laboratories, Inc." BLATELLA GERMANICA 1
g/10mL "Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Re
ALLERGENIC Alternaria Alternaria alternata INJECTION
CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA10221
2 "Allermed Laboratories, Inc." ALTERNARIA ALTERNATA 1 g/10mL
ALLERGENIC Botrytis Botrytis cinerea INJECTION
2 "Allermed Laboratories, Inc." BOTRYTIS CINEREA 1 g/10mL
ALLERGENIC Candida Candida albicans INJECTION CUTANEOU
"Allermed Laboratories, Inc." CANDIDA ALBICANS 1 g/20mL "Cell-me
ALLERGENIC Cephalosporium Cephalosporium roseum INJECTION
2 "Allermed Laboratories, Inc." CEPHALOSPORIUM ROSEUM 1 g/10mL
ALLERGENIC Chaetomium Chaetomium globosum INJECTION
2 "Allermed Laboratories, Inc." CHAETOMIUM GLOBOSUM 1 g/10mL
ALLERGENIC Cladosporium Cladosporium herbarum INJECTION
2 "Allermed Laboratories, Inc." CLADOSPORIUM HERBARUM 1 g/10mL
ALLERGENIC Curvularia Curvularia lunata INJECTION
2 "Allermed Laboratories, Inc." COCHLIOBOLUS LUNATUS 1 g/10mL
ALLERGENIC Epicoccum Epicoccum nigrum INJECTION
2 "Allermed Laboratories, Inc." EPICOCCUM NIGRUM 1 g/10mL
"Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [
Histamine Release [PE],Cell-mediated Immunity [PE]"
ALLERGENIC Fusarium Fusarium solani INJECTION CUTANEOU
"Allermed Laboratories, Inc." HAEMATONECTRIA HAEMATOCOCCA 1 g/10mL
ALLERGENIC Helminthosporium sativum Helminthosporium sativum
INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312
BLA BLA102212 "Allermed Laboratories, Inc." COCHLIOBOLUS SATIVUS
ALLERGENIC Monilia Monilia sitophila INJECTION CUTANEOU
"Allermed Laboratories, Inc." CHRYSONILIA SITOPHILA 1 g/10mL "Non-Sta
ALLERGENIC Mucor Mucor racemosus INJECTION CUTANEOUS; INTRA
DERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 "Allerme
d Laboratories, Inc." MUCOR RACEMOSUS 1 g/10mL "Non-Standardized Fungal
ALLERGENIC Penicillium Penicillium chrysogenum INJECTION
2 "Allermed Laboratories, Inc." PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM
ALLERGENIC Phoma Phoma betae INJECTION CUTANEOUS; INTRA
d Laboratories, Inc." PLEOSPORA BETAE 1 g/10mL "Non-Standardized Fungal
ALLERGENIC Pullularia Pullularia pullulans INJECTION
2 "Allermed Laboratories, Inc." AUREOBASIDIUM PULLULANS VAR. PULLUTANS
ALLERGENIC Rhizopus Rhizopus oryzae INJECTION CUTANEOU
"Allermed Laboratories, Inc." RHIZOPUS ARRHIZUS VAR. ARRHIZUS 1 g/10mL
ALLERGENIC "Rust, Wheat" Puccinia striiformis INJECTION
2 "Allermed Laboratories, Inc." PUCCINIA STRIIFORMIS VAR. STRIIFORMIS
gal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardi
zed Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediat
ed Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredi
ent],Allergens [Chemical/Ingredient]"
ALLERGENIC "Smut, Corn" Ustilago maydis INJECTION CUTANEOU
"Allermed Laboratories, Inc." USTILAGO MAYDIS 1 g/20mL "Non-Standardize
ALLERGENIC "Smut, Johnson Grass" Sphacelotheca cruenta INJECTIO
BLA102212 "Allermed Laboratories, Inc." SPORISORIUM CRUENTUM 1
ALLERGENIC "Smut, Wheat" Tilletia caries (tritici) INJECTIO
BLA102212 "Allermed Laboratories, Inc." TILLECIA CARIES 1 g/20mL
ALLERGENIC Stemphylium Stemphylium botryosum INJECTION
2 "Allermed Laboratories, Inc." PLEOSPORA TARDA 1 g/10mL "Non-Sta
49643-128_f7d4e8ff-edb0-4e5c-a1b6-72635e9b2e3a 49643-128 HUMAN PRESCRIPTI
ON DRUG Trichophyton for Intradermal Skin Testing Trichophyton men
tagrophytes and Trichophyton rubrum INJECTION CUTANEOUS; INTRADERMAL;
tories, Inc." TRICHOPHYTON MENTAGROPHYTES; TRICHOPHYTON RUBRUM 1; 1
g/1000mL; g/1000mL "Non-Standardized Fungal Allergenic Extract [EPC],Increa
[PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-S
tandardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cel
l-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical
ALLERGENIC Aspergillus fumigatus Aspergillus fumigatus INJECTIO
BLA102212 "Allermed Laboratories, Inc." ASPERGILLUS FUMIGATUS 1
ergens [Chemical/Ingredient]"
49643-138_32ded8da-98ea-4cda-b49e-16d4491c8ade 49643-138 STANDARDIZED ALL
ERGENIC Candin Candida albicans Skin Test Antigen "INJECTION, SOLU
TION" INTRADERMAL 19951201 BLA BLA103257 "Allerme
d Laboratories, Inc." CANDIDA ALBICANS 1 U/.1mL "Cell-mediated I
ALLERGENIC Alfalfa Pollen Medicago sativa INJECTION CUTANEOU
"Allermed Laboratories, Inc." MEDICAGO SATIVA POLLEN 1 g/50mL "Non-Sta
ALLERGENIC Acacia Pollen Acacia spp. INJECTION CUTANEOU
"Allermed Laboratories, Inc." ACACIA POLLEN 1 g/20mL "Non-Standardize
ALLERGENIC Coast Maple Pollen Acer macrophyllum INJECTIO
BLA102212 "Allermed Laboratories, Inc." ACER MACROPHYLLUM POLLEN
1 g/20mL "Increased IgG Production [PE],Pollen [Chemical/Ingredient],Alle
reased Histamine Release [PE],Cell-mediated Immunity [PE]"
ALLERGENIC Box Elder Maple Pollen Acer negundo INJECTION
2 "Allermed Laboratories, Inc." ACER NEGUNDO POLLEN 1 g/20mL
ALLERGENIC Silver Maple Pollen Acer saccharinum INJECTIO
BLA102212 "Allermed Laboratories, Inc." ACER SACCHARINUM POLLEN 1
ALLERGENIC Western Waterhemp Pollen Acnida tamariscina
BLA BLA102212 "Allermed Laboratories, Inc." AMARANTHUS TUBERCULATUS
POLLEN 1 g/20mL "Non-Standardized Pollen Allergenic Extract [EPC],Increa
EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG
Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
ALLERGENIC Quackgrass Pollen Agropyron repens INJECTIO
BLA102212 "Allermed Laboratories, Inc." ELYMUS REPENS POLLEN 1
ALLERGENIC Western Wheatgrass Pollen Agropyron smithii
BLA BLA102212 "Allermed Laboratories, Inc." PASCOPYRUM SMITHII POLLE
49643-309_e24f1cbe-e247-4bcd-aa7c-b0d297e815ac 49643-309 HUMAN PRESCRIPTI
ON DRUG Standardized Redtop Grass Agrostis alba INJECTION
8 "Allermed Laboratories, Inc." AGROSTIS GIGANTEA POLLEN 100000
[BAU]/mL "Standardized Pollen Allergenic Extract [EPC],Non-Standardized P
ollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Im
munity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens
ALLERGENIC Tree of Heaven Pollen Ailanthus altissima INJECTIO
BLA102212 "Allermed Laboratories, Inc." AILANTHUS ALTISSIMA POLLEN
ALLERGENIC Iodine Bush Pollen Allenrolfea occidentalis
BLA BLA102212 "Allermed Laboratories, Inc." ALLENROLFEA OCCIDENTALIS
ALLERGENIC "Alder, White Pollen" Alnus rhombifolia INJECTIO
BLA102212 "Allermed Laboratories, Inc." ALNUS RHOMBIFOLIA POLLEN
ALLERGENIC Careless Weed Pollen Amaranthus palmerii INJECTIO
BLA102212 "Allermed Laboratories, Inc." AMARANTHUS PALMERI POLLEN
ALLERGENIC Redroot Pigweed Pollen Amaranthus retroflexus INJECTIO
BLA102212 "Allermed Laboratories, Inc." AMARANTHUS RETROFLEXUS POLLEN
49643-315_27d42b75-737c-42aa-9ecf-25373fcd0fb0 49643-315 HUMAN PRESCRIPTI
ON DRUG Short Ragweed Ambrosia artemisiifolia INJECTION CUTANEOU
"Allermed Laboratories, Inc." AMBROSIA ARTEMISIIFOLIA POLLEN 1 g/10mL
ALLERGENIC Western Ragweed Pollen Ambrosia psilostachia INJECTIO
BLA102212 "Allermed Laboratories, Inc." AMBROSIA PSILOSTACHYA POLLEN
ALLERGENIC Giant Ragweed Pollen Ambrosia trifida INJECTIO
BLA102212 "Allermed Laboratories, Inc." AMBROSIA TRIFIDA POLLEN 1
lease [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [C
ON DRUG Standardized Sweet Vernal Grass Anthoxanthum odoratum INJECTIO
BLA102220 "Allermed Laboratories, Inc." ANTHOXANTHUM ODORATUM POLLEN
ALLERGENIC Wormwood Sage Pollen Artemisia absinthium INJECTIO
BLA102212 "Allermed Laboratories, Inc." ARTEMISIA ABSINTHIUM POLLEN
ALLERGENIC Common Sage Pollen Artemisia tridentata INJECTIO
BLA102212 "Allermed Laboratories, Inc." ARTEMISIA TRIDENTATA POLLEN
ALLERGENIC Mugwort Sage Pollen Artemisia vulgaris INJECTIO
BLA102212 "Allermed Laboratories, Inc." ARTEMISIA VULGARIS POLLEN
ALLERGENIC Cultivated Oat Pollen Avena sativa INJECTION
2 "Allermed Laboratories, Inc." AVENA SATIVA POLLEN 1 g/20mL
ALLERGENIC Bassia Pollen Bassia hyssopifolia INJECTION
2 "Allermed Laboratories, Inc." BASSIA HYSSOPIFOLIA POLLEN 1
ALLERGENIC Sugar Beet Pollen Beta vulgaris INJECTION
2 "Allermed Laboratories, Inc." BETA VULGARIS POLLEN 1 g/20mL
ALLERGENIC Gray (White) Birch Pollen Betula populifolia
BLA BLA102212 "Allermed Laboratories, Inc." BETULA POPULIFOLIA POLLE
ALLERGENIC Grama grass Pollen Bouteloua spp. INJECTION
2 "Allermed Laboratories, Inc." BOUTELOUA GRACILIS POLLEN 1
ALLERGENIC Mustard Pollen Brassica campestris INJECTION
2 "Allermed Laboratories, Inc." BRASSICA RAPA POLLEN 1 g/20mL
ALLERGENIC Smooth Brome Pollen Bromus inermis INJECTION
2 "Allermed Laboratories, Inc." BROMUS INERMIS POLLEN 1 g/20mL
t]"
ALLERGENIC Cheat Grass Pollen Bromus secalinus INJECTIO
BLA102212 "Allermed Laboratories, Inc." BROMUS SECALINUS POLLEN 1
ALLERGENIC Bottlebrush Pollen Callistemon citrinus INJECTIO
BLA102212 "Allermed Laboratories, Inc." CALLISTEMON CITRINUS POLLEN
ALLERGENIC Shagbark Hickory Pollen Carya ovata INJECTION
2 "Allermed Laboratories, Inc." CARYA OVATA POLLEN 1 g/20mL
ALLERGENIC White Hickory Pollen Carya tomentosa INJECTION
2 "Allermed Laboratories, Inc." CARYA ALBA POLLEN 1 g/20mL
ALLERGENIC Australian Pine Pollen Casuarina equisetifoli INJECTIO
BLA102212 "Allermed Laboratories, Inc." CASUARINA EQUISETIFOLIA POLLEN
ALLERGENIC Hackberry Pollen Celtis occidentalis INJECTIO
BLA102212 "Allermed Laboratories, Inc." CELTIS OCCIDENTALIS POLLEN
ALLERGENIC Palo Verde Pollen Cercidium torreyana INJECTIO
BLA102212 "Allermed Laboratories, Inc." CERCIDIUM FLORIDUM SSP. FLORIDUM
ALLERGENIC Lambs Quarters Pollen Chenopodium album INJECTIO
BLA102212 "Allermed Laboratories, Inc." CHENOPODIUM ALBUM POLLEN
ALLERGENIC Hazelnut Pollen Corylus americana INJECTION
2 "Allermed Laboratories, Inc." CORYLUS AMERICANA POLLEN 1
ALLERGENIC "Cypress, Arizona Pollen" Cupressus arizonica
BLA BLA102212 "Allermed Laboratories, Inc." CUPRESSUS ARIZONICA POLL
EN 1 g/20mL "Non-Standardized Pollen Allergenic Extract [EPC],Increa
ON DRUG Standardized Bermuda Grass CYNODON DACTYLON INJECTIO
BLA102214 "Allermed Laboratories, Inc." CYNODON DACTYLON POLLEN 10000
ON DRUG Standardized Orchard Grass Dactylis glomerata INJECTIO
BLA102217 "Allermed Laboratories, Inc." DACTYLIS GLOMERATA POLLEN
ALLERGENIC Silver Ragweed Pollen Dicoria canescens INJECTIO
BLA102212 "Allermed Laboratories, Inc." DICORIA CANESCENS POLLEN
ALLERGENIC Salt Grass Pollen Distichlis spicata INJECTIO
BLA102212 "Allermed Laboratories, Inc." DISTICHLIS SPICATA POLLEN
ALLERGENIC Russian Olive Pollen Elaeagnus angustifolia INJECTIO
BLA102212 "Allermed Laboratories, Inc." ELAEAGNUS ANGUSTIFOLIA POLLEN
ALLERGENIC Eucalyptus Pollen Eucalyptus globulus INJECTIO
BLA102212 "Allermed Laboratories, Inc." EUCALYPTUS GLOBULUS POLLEN
ALLERGENIC Winterfat Pollen Eurotia lanata INJECTION
2 "Allermed Laboratories, Inc." KRASCHENINNIKOVIA LANATA POLLEN 1
ngredient]"
ALLERGENIC Beech Pollen Fagus grandifolia INJECTION
2 "Allermed Laboratories, Inc." FAGUS GRANDIFOLIA POLLEN 1
ON DRUG Standardized Meadow Fescue Grass Festuca elatior INJECTIO
BLA102216 "Allermed Laboratories, Inc." FESTUCA PRATENSIS POLLEN
ALLERGENIC False Ragweed Pollen Ambrosia acanthicarpa INJECTIO
BLA102212 "Allermed Laboratories, Inc." AMBROSIA ACANTHICARPA POLLEN
ALLERGENIC Canyon Ragweed Pollen Ambrosia ambrosioides INJECTIO
BLA102212 "Allermed Laboratories, Inc." AMBROSIA AMBROSIOIDES POLLEN
ALLERGENIC Sandbur Ragweed Pollen Ambrosia bipinnatifida INJECTIO
BLA102212 "Allermed Laboratories, Inc." AMBROSIA CHAMISSONIS POLLEN
ALLERGENIC Rabbitbush Pollen Ambrosia deltoides INJECTIO
BLA102212 "Allermed Laboratories, Inc." AMBROSIA DELTOIDEA POLLEN
ALLERGENIC Desert Ragweed Pollen Ambrosia dumosa INJECTION
2 "Allermed Laboratories, Inc." AMBROSIA DUMOSA POLLEN 1 g/20mL
Ingredient]"
ALLERGENIC Slender Ragweed Pollen Ambrosia tenuifolia INJECTIO
BLA102212 "Allermed Laboratories, Inc." AMBROSIA TENUIFOLIA POLLEN
ALLERGENIC White Ash Pollen Fraxinus americana INJECTIO
BLA102212 "Allermed Laboratories, Inc." FRAXINUS AMERICANA POLLEN
ALLERGENIC Green Ash Pollen Fraxinus pennsylvanica INJECTIO
BLA102212 "Allermed Laboratories, Inc." FRAXINUS PENNSYLVANICA POLLEN
ALLERGENIC Arizona Ash Pollen Fraxinus velutina INJECTIO
BLA102212 "Allermed Laboratories, Inc." FRAXINUS VELUTINA POLLEN
ALLERGENIC Sunflower Pollen Helianthus annua INJECTIO
BLA102212 "Allermed Laboratories, Inc." HELIANTHUS ANNUUS POLLEN
ALLERGENIC Velvet Grass Pollen Holcus lanatus INJECTION
2 "Allermed Laboratories, Inc." HOLCUS LANATUS POLLEN 1 g/20mL
t]"
ALLERGENIC Burrobrush Pollen Hymenoclea salsola INJECTIO
BLA102212 "Allermed Laboratories, Inc." HYMENOCLEA SALSOLA POLLEN
ALLERGENIC Poverty Weed Pollen Iva axillaris INJECTION
2 "Allermed Laboratories, Inc." IVA AXILLARIS POLLEN 1 g/20mL
ALLERGENIC Rough Marshelder Pollen Iva ciliata INJECTION
2 "Allermed Laboratories, Inc." IVA ANNUA VAR. ANNUA POLLEN 1
ALLERGENIC Burweed Marshelder Pollen Iva xanthifolia INJECTIO
BLA102212 "Allermed Laboratories, Inc." IVA XANTHIFOLIA POLLEN 1
ALLERGENIC Black Walnut Pollen Juglans nigra INJECTION
2 "Allermed Laboratories, Inc." JUGLANS NIGRA POLLEN 1 g/20mL
ALLERGENIC English Walnut Pollen Juglans regia INJECTION
2 "Allermed Laboratories, Inc." JUGLANS REGIA POLLEN 1 g/20mL
ALLERGENIC California Juniper Pollen Juniperus californica
BLA BLA102212 "Allermed Laboratories, Inc." JUNIPERUS CALIFORNICA PO
LLEN 1 g/20mL "Non-Standardized Pollen Allergenic Extract [EPC],Increa
ALLERGENIC Western Juniper Pollen Juniperus occidentalis INJECTIO
BLA102212 "Allermed Laboratories, Inc." JUNIPERUS OCCIDENTALIS POLLEN
ALLERGENIC Utah Juniper Pollen Juniperus osteosperma INJECTIO
BLA102212 "Allermed Laboratories, Inc." JUNIPERUS OSTEOSPERMA POLLEN
ALLERGENIC Mountain Cedar Pollen Juniperus sabinoides INJECTIO
BLA102212 "Allermed Laboratories, Inc." JUNIPERUS ASHEI POLLEN 1
ALLERGENIC Rocky Mtn. Juniper Pollen Juniperus scopulorum
BLA BLA102212 "Allermed Laboratories, Inc." JUNIPERUS SCOPULORUM POL
ALLERGENIC Red Cedar Pollen Juniperus virginiana INJECTIO
BLA102212 "Allermed Laboratories, Inc." JUNIPERUS VIRGINIANA POLLEN
ALLERGENIC Burning Bush Pollen Kochia scoparia INJECTION
2 "Allermed Laboratories, Inc." KOCHIA SCOPARIA POLLEN 1 g/20mL
ALLERGENIC Koelers Grass Pollen Koeleria cristata INJECTIO
BLA102212 "Allermed Laboratories, Inc." KOELERIA MACRANTHA POLLEN
ALLERGENIC Privet Pollen Ligustrum vulgare INJECTION
2 "Allermed Laboratories, Inc." LIGUSTRUM VULGARE POLLEN 1
ALLERGENIC Sweet Gum Pollen Liquidamber styraciflua INJECTIO
BLA102212 "Allermed Laboratories, Inc." LIQUIDAMBAR STYRACIFLUA POLLEN
ON DRUG Standardized Perennial Rye Grass Lolium perenne INJECTIO
BLA102219 "Allermed Laboratories, Inc." LOLIUM PERENNE POLLEN 100000
ALLERGENIC Melaleuca Pollen Melaleuca leucadendron INJECTIO
BLA102212 "Allermed Laboratories, Inc." MELALEUCA QUINQUENERVIA POLLEN
ALLERGENIC White Mulbery Pollen Morus alba INJECTION
2 "Allermed Laboratories, Inc." MORUS ALBA POLLEN 1 g/20mL
ALLERGENIC European Olive Pollen Olea europea INJECTION
2 "Allermed Laboratories, Inc." OLEA EUROPAEA POLLEN 1 g/20mL
ALLERGENIC Bahia Grass Pollen Paspalum notatum INJECTIO
BLA102212 "Allermed Laboratories, Inc." PASPALUM NOTATUM POLLEN 1
ALLERGENIC Canary Grass Pollen Phalaris arundinaceae INJECTIO
BLA102212 "Allermed Laboratories, Inc." PHALARIS ARUNDINACEA POLLEN
ON DRUG Standardized Timothy Grass Phleum pratense INJECTION
1 "Allermed Laboratories, Inc." PHLEUM PRATENSE POLLEN 100000 [BAU]/mL
ALLERGENIC Date Palm Pollen Phoenix dactylifera INJECTIO
BLA102212 "Allermed Laboratories, Inc." PHOENIX DACTYLIFERA POLLEN
ALLERGENIC Eastern White Pine Pollen Pinus strobus INJECTIO
BLA102212 "Allermed Laboratories, Inc." PINUS STROBUS POLLEN 1
ALLERGENIC English Plantain Pollen Plantago lanceolata INJECTIO
BLA102212 "Allermed Laboratories, Inc." PLANTAGO LANCEOLATA POLLEN
ALLERGENIC Eastern Sycamore Pollen Platanus occidentalis INJECTIO
BLA102212 "Allermed Laboratories, Inc." PLATANUS OCCIDENTALIS POLLEN
ALLERGENIC Western Sycamore Pollen Platanus racemosa INJECTIO
BLA102212 "Allermed Laboratories, Inc." PLATANUS RACEMOSA POLLEN
ON DRUG Standardized Kentucky Blue (June) Grass Poa pratensis INJECTIO
BLA102215 "Allermed Laboratories, Inc." POA PRATENSIS POLLEN 100000
ALLERGENIC White Poplar Pollen Populus alba INJECTION
2 "Allermed Laboratories, Inc." POPULUS ALBA POLLEN 1 g/20mL
ALLERGENIC Eastern Cottonwood Pollen Populus deltoides
BLA BLA102212 "Allermed Laboratories, Inc." POPULUS DELTOIDES POLLEN
ALLERGENIC Fremont Cottonwood Pollen Populus fremontii
BLA BLA102212 "Allermed Laboratories, Inc." POPULUS FREMONTII POLLEN
ALLERGENIC Lombard Poplar Pollen Populus nigra INJECTION
2 "Allermed Laboratories, Inc." POPULUS NIGRA POLLEN 1 g/20mL
ALLERGENIC Aspen Pollen Populus tremuloides INJECTION
2 "Allermed Laboratories, Inc." POPULUS TREMULOIDES POLLEN 1
ALLERGENIC Black Cottonwood Pollen Populus trichocarpa INJECTIO
BLA102212 "Allermed Laboratories, Inc." POPULUS BALSAMIFERA SSP. TRICHOC
ARPA POLLEN 1 g/20mL "Non-Standardized Pollen Allergenic Extract [EPC
ALLERGENIC Mesquite Pollen Prosopis juliflora INJECTION
2 "Allermed Laboratories, Inc." PROSOPIS JULIFLORA POLLEN 1
ALLERGENIC Coast Live Oak Pollen Quercus agrifolia INJECTIO
BLA102212 "Allermed Laboratories, Inc." QUERCUS AGRIFOLIA POLLEN
ALLERGENIC White Oak Pollen Quercus alba INJECTION
2 "Allermed Laboratories, Inc." QUERCUS ALBA POLLEN 1 g/20mL
ALLERGENIC California Scrub Oak Pollen Quercus dumosa INJECTIO
BLA102212 "Allermed Laboratories, Inc." QUERCUS DUMOSA POLLEN 1
ALLERGENIC Gambels Oak Pollen Quercus gambelii INJECTIO
BLA102212 "Allermed Laboratories, Inc." QUERCUS GAMBELII POLLEN 1
ALLERGENIC Sheep Sorrel Pollen Rumex acetosella INJECTIO
BLA102212 "Allermed Laboratories, Inc." RUMEX ACETOSELLA POLLEN 1
mine Release [PE],Allergens [Chemical/Ingredient]"
ALLERGENIC "Dock, Yellow Pollen" Rumex crispus INJECTION
2 "Allermed Laboratories, Inc." RUMEX CRISPUS POLLEN 1 g/20mL
ALLERGENIC Pussy Willow Pollen Salix discolor INJECTION
2 "Allermed Laboratories, Inc." SALIX DISCOLOR POLLEN 1 g/20mL
ALLERGENIC Arroyo Willow Pollen Salix lasiolepsis INJECTIO
BLA102212 "Allermed Laboratories, Inc." SALIX LASIOLEPIS POLLEN 1
ALLERGENIC Black Willow Pollen Salix nigra INJECTION
2 "Allermed Laboratories, Inc." SALIX NIGRA POLLEN 1 g/20mL
ALLERGENIC Russian Thistle Pollen Salsola kali INJECTION
2 "Allermed Laboratories, Inc." SALSOLA KALI POLLEN 1 g/20mL
ALLERGENIC Greasewood Pollen Sarcobatus vermiculatus INJECTIO
BLA102212 "Allermed Laboratories, Inc." SARCOBATUS VERMICULATUS POLLEN
ALLERGENIC Pepper Tree Pollen Schinus molle INJECTION
2 "Allermed Laboratories, Inc." SCHINUS MOLLE POLLEN 1 g/20mL
ALLERGENIC Johnson Grass Pollen Sorghum halepense INJECTIO
BLA102212 "Allermed Laboratories, Inc." SORGHUM HALEPENSE POLLEN
ALLERGENIC Alkali Blite Pollen Suaeda spp. INJECTION
2 "Allermed Laboratories, Inc." SUAEDA MOQUINII POLLEN 1 g/20mL
ALLERGENIC Salt Cedar Pollen Tamarix gallica INJECTION
2 "Allermed Laboratories, Inc." TAMARIX GALLICA POLLEN 1 g/20mL
t]"
ALLERGENIC Dandelion Pollen Taraxacum officinale INJECTIO
BLA102212 "Allermed Laboratories, Inc." TARAXACUM OFFICINALE POLLEN
ALLERGENIC American Elm Pollen Ulmus americana INJECTION
2 "Allermed Laboratories, Inc." ULMUS AMERICANA POLLEN 1 g/20mL
ALLERGENIC Chinese Elm Pollen Ulmus pumila INJECTION
2 "Allermed Laboratories, Inc." ULMUS PUMILA POLLEN 1 g/20mL
ALLERGENIC Cocklebur Pollen Xanthium commune INJECTIO
BLA102212 "Allermed Laboratories, Inc." XANTHIUM STRUMARIUM POLLEN
ALLERGENIC Corn Pollen Pollen Zea mays INJECTION
2 "Allermed Laboratories, Inc." ZEA MAYS POLLEN 1 g/20mL "Non-Sta
ALLERGENIC Nettle Pollen Urtica dioica INJECTION CUTANEOU
"Allermed Laboratories, Inc." URTICA DIOICA POLLEN 1 g/20mL "Non-Sta
ALLERGENIC Red Maple Pollen Acer rubrum INJECTION
2 "Allermed Laboratories, Inc." ACER RUBRUM POLLEN 1 g/20mL
ALLERGENIC Red Alder Pollen Alnus rubra INJECTION
2 "Allermed Laboratories, Inc." ALNUS RUBRA POLLEN 1 g/20mL
ALLERGENIC Tag Alder Pollen Alnus rugosa INJECTION
2 "Allermed Laboratories, Inc." ALNUS INCANA SSP. RUGOSA POLLEN 1
ALLERGENIC Coast Sage Pollen Artemisia californica INJECTIO
BLA102212 "Allermed Laboratories, Inc." ARTEMISIA CALIFORNICA POLLEN
ALLERGENIC Wing Scale Pollen Atriplex canescens INJECTIO
BLA102212 "Allermed Laboratories, Inc." ATRIPLEX CANESCENS POLLEN
ALLERGENIC Shad Scale Pollen Atriplex confertifolia INJECTIO
BLA102212 "Allermed Laboratories, Inc." ATRIPLEX CONFERTIFOLIA POLLEN
emical/Ingredient]"
ALLERGENIC Lens Scale Pollen Atriplex lentiformis INJECTIO
BLA102212 "Allermed Laboratories, Inc." ATRIPLEX LENTIFORMIS POLLEN
ALLERGENIC Spring Birch Pollen Betula fontinalis INJECTIO
BLA102212 "Allermed Laboratories, Inc." BETULA OCCIDENTALIS POLLEN
ALLERGENIC Cherry Birch Pollen Betula lenta INJECTION
2 "Allermed Laboratories, Inc." BETULA LENTA POLLEN 1 g/20mL
ALLERGENIC River/Red Birch Pollen Betula nigra INJECTION
2 "Allermed Laboratories, Inc." BETULA NIGRA POLLEN 1 g/20mL
ALLERGENIC Pecan Pollen Carya illinoinensis INJECTION
2 "Allermed Laboratories, Inc." CARYA ILLINOINENSIS POLLEN 1
ALLERGENIC Calif. Black Walnut Pollen Juglans californica
BLA BLA102212 "Allermed Laboratories, Inc." JUGLANS CALIFORNICA POLL
EN 1 g/20mL "Non-Standardized Pollen Allergenic Extract [EPC],Cell-m
ediated Immunity [PE],Increased IgG Production [PE],Increased Histamine Release
ALLERGENIC Red Mulberry Pollen Morus rubra INJECTION
2 "Allermed Laboratories, Inc." MORUS RUBRA POLLEN 1 g/20mL
ALLERGENIC Shortleaf Pine Pollen Pinus echinata INJECTION
2 "Allermed Laboratories, Inc." PINUS ECHINATA POLLEN 1 g/20mL
ALLERGENIC Yellow Pine Pollen Pinus ponderosa INJECTION
2 "Allermed Laboratories, Inc." PINUS PONDEROSA POLLEN 1 g/20mL
t]"
ALLERGENIC Red Oak Pollen Quercus rubra INJECTION CUTANEOU
"Allermed Laboratories, Inc." QUERCUS RUBRA POLLEN 1 g/20mL "Non-Sta
ALLERGENIC Black Oak Pollen Quercus velutina INJECTIO
BLA102212 "Allermed Laboratories, Inc." QUERCUS VELUTINA POLLEN 1
ALLERGENIC Hard Maple Pollen Acer saccharum INJECTION
2 "Allermed Laboratories, Inc." ACER SACCHARUM POLLEN 1 g/20mL
ALLERGENIC Linden Pollen Tilia cordata INJECTION CUTANEOU
"Allermed Laboratories, Inc." TILIA CORDATA POLLEN 1 g/20mL "Non-Sta
49643-702_5664e19e-6019-4b8b-b2d0-c349910bcf07 49643-702 HUMAN PRESCRIPTI
ON DRUG "House Dust Mite, Dermatophagoides farinae" "House Dust Mite
, Dermatophagoides farinae" INJECTION CUTANEOUS; INTRADERMAL; SUBCUTAN
EOUS 19861224 BLA BLA102212 "Allermed Laboratories,
Inc." DERMATOPHAGOIDES FARINAE 10000 [AU]/mL "Standardized Insect All
E],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient
],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
49643-704_5664e19e-6019-4b8b-b2d0-c349910bcf07 49643-704 HUMAN PRESCRIPTI
ON DRUG "House Dust Mite, Dermatophagoides pteronyssinus" "House D
ust Mite, Dermatophagoides pteronyssinus" INJECTION CUTANEOUS; INTRA
d Laboratories, Inc." DERMATOPHAGOIDES PTERONYSSINUS 10000 [AU]/mL "Standar
edient]"
49643-705_4794134f-8c59-4a48-bcb3-032bd384dc4e 49643-705 HUMAN PRESCRIPTI
ON DRUG Cat Hair Cat Hair INJECTION CUTANEOUS; INTRA
d Laboratories, Inc." FELIS CATUS HAIR 10000 [BAU]/mL "Standar
edient]"
ALLERGENIC Glycerol-Saline Control Glycerol-Saline Diluent INJECTIO
BLA102212 "Allermed Laboratories, Inc." GLYCERIN 53 g/100mL
"Non-Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-
mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredi
ent],Glycerol [Chemical/Ingredient]"
49471-001_2fbcc40c-f102-4abe-bce5-a93de95874fe 49471-001 HUMAN PRESCRIPTI
ON DRUG PRE-PEN benzylpenicilloyl polylysine INJECTION INTRADER
MAL; SUBCUTANEOUS 19740725 NDA NDA050114 AllerQue
st LLC BENZYLPENICILLOYL POLYLYSINE 60 umol/.25mL
50562-001_4e6644f4-a969-43ea-80c1-ff92a2c67399 50562-001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS Alliance Welding Supplies Inc dba Atlas Welding
Supply OXYGEN 992 mL/L
50562-002_eda0896a-9db8-4e5e-8294-6d9212dfa5ff 50562-002 HUMAN PRESCRIPTI
20100601 UNAPPROVED MEDICAL GAS Alliance Welding Supplie
s Inc dba Atlas Welding Supply NITROGEN 992 mL/L
52546-100_18cf4720-ab4c-4b0e-9391-71e86ae53dd9 52546-100 HUMAN OTC DRUG
Smith and Johnson Antibacterial TRICLOSAN LIQUID TOPICAL 20100621
OTC MONOGRAPH NOT FINAL part333 Allied International Corp TRICLOSAN
0.115 mL/100mL
52546-110_f9685c0b-c691-438c-b1c3-73cb1348418d 52546-110 HUMAN OTC DRUG
Smith and Johnson Antibacterial TRICLOSAN SOAP TOPICAL 20110519
OTC MONOGRAPH FINAL part333E Allied International Corp TRICLOSA
N 0.115 mL/100mL
76267-060_fb817546-31ae-410a-812d-0e5ceafbf1dc 76267-060 HUMAN PRESCRIPTI
20121231 ANDA ANDA202710 Allied Pharma Inc CLARITHR
76267-061_fb817546-31ae-410a-812d-0e5ceafbf1dc 76267-061 HUMAN PRESCRIPTI
20121231 ANDA ANDA202710 Allied Pharma Inc CLARITHR
76267-150_cc42779d-9cf2-4dc5-a770-483c0ab7d976 76267-150 HUMAN PRESCRIPTI
20130602 ANDA ANDA203244 Allied Pharma Inc GABAPENT
76267-151_cc42779d-9cf2-4dc5-a770-483c0ab7d976 76267-151 HUMAN PRESCRIPTI
20130602 ANDA ANDA203244 Allied Pharma Inc GABAPENT
67587-001_1d3b0ea6-b2b8-43df-b001-ece1677f6f89 67587-001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS Allina Home Oxygen and Medical Equipment
OXYGEN 99 L/100L
86227-000_4bab2f34-5966-4fb5-a081-bec2a811b314 86227-000 HUMAN OTC DRUG
Sure Comfort Alcohol Prep Pads ISOPROPYL ALCOHOL LIQUID TOPICAL
20131204 OTC MONOGRAPH NOT FINAL part333A Allison Medical
Inc. ISOPROPYL ALCOHOL 70 g/100g
52019-001_6e390a81-11d0-48d6-b8b1-591efe1aac8a 52019-001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS "All-Med, Inc" OXYGEN 99 L/100L
48818-001_3783e7ed-7fb8-4b58-96e6-bc108cea99b2 48818-001 HUMAN PRESCRIPTI
ON DRUG Folotyn pralatrexate INJECTION INTRAVENOUS 20090924
NDA NDA022468 Allos Therapeutics PRALATREXATE 20 mg/mL
Folate Analog Metabolic Inhibitor [EPC]
53817-001_9bd554e7-c549-46dc-8914-b29ce6aa2d48 53817-001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS Alloy Oxygen & Welding Supply Co. Inc. OXYGEN
992 mL/L
62742-4031_b552f601-7915-4822-8202-136919ba22fb 62742-4031 HUMAN OTC DRUG
Lycogel Cover and Recovery - Breathable Camouflage - SPF 30 with LYCO Complex
Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20100201 UNAPPROV
ED DRUG OTHER "Allure Cosmetic, Inc." TITANIUM DIOXIDE; ZINC OXIDE
65; 82 mg/mL; mg/mL
62742-4032_6cd649e2-95e4-4138-b16d-9e95e2f328b8 62742-4032 HUMAN OTC DRUG
Lycogel Cover and Recovery - Breathable Concealer - SPF 30 with LYCO Complex
Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20100201 UNAPPROV
ED DRUG OTHER "Allure Cosmetic, Inc." TITANIUM DIOXIDE; ZINC OXIDE
65; 82 mg/mL; mg/mL
62742-4064_2aeda5d4-0cd2-4cd8-a12d-880ded11d9d2 62742-4064 HUMAN OTC DRUG
ZinClear SPF 30 Tinted Zinc Oxide CREAM TOPICAL 20140422
OTC MONOGRAPH FINAL part352 Allure Labs Inc. ZINC OXIDE 186
mg/g
62742-4059_ec8a7b23-aa83-406f-854b-a3474a716798 62742-4059 HUMAN OTC DRUG
No Concealer Concealer Titanium Dioxide and Zinc Oxide CREAM TOPICAL
20131209 OTC MONOGRAPH FINAL part352 "Allure Labs, Inc"
TITANIUM DIOXIDE; ZINC OXIDE 48; 58.8 mg/g; mg/g
62742-4060_908dfa20-4f1d-4c34-b85e-f5ec09b7eda7 62742-4060 HUMAN OTC DRUG
No Foundation Foundation Fair Zinc Oxide and Titanium Dioxide CREAM
TOPICAL 20131216 OTC MONOGRAPH FINAL part352 "Allure Labs, In
c" TITANIUM DIOXIDE; ZINC OXIDE 32; 122 mg/mL; mg/mL
62742-4062_7ff3a174-91b1-4411-bdc2-95b4a2369eac 62742-4062 HUMAN OTC DRUG
No Concealer Concealer No.2 Light to Medium Titanium Dioxide and Zin
c Oxide CREAM TOPICAL 20140326 OTC MONOGRAPH FINAL part352
"Allure Labs, Inc" TITANIUM DIOXIDE; ZINC OXIDE 48; 58.8 mg/g; mg
/g
62742-4063_be855b3f-4c30-48f4-9fbb-514209d00242 62742-4063 HUMAN OTC DRUG
No Foundation Foundation No.1 Fair to Light Zinc Oxide and Titanium
Dioxide CREAM TOPICAL 20140418 OTC MONOGRAPH FINAL part352
"Allure Labs, Inc" TITANIUM DIOXIDE; ZINC OXIDE 32; 122 mg/mL; mg/mL
62742-4067_e200363c-eb83-4b5d-be27-390b206852f9 62742-4067 HUMAN OTC DRUG
Prevention daily tinted mositurizer oil-free Tinted 30 Zinc Oxide and T
itanium Dioxide CREAM TOPICAL 20140509 OTC MONOGRAPH FINAL
part352 "Allure Labs, Inc" TITANIUM DIOXIDE; ZINC OXIDE 46; 60 mg/g; mg
/g
62742-4068_c212882f-4802-4f7c-b4f4-3b71ec62ac04 62742-4068 HUMAN OTC DRUG
Youth Protection SPF 30 Zinc Oxide and Titanium Dioxide CREAM TOPICAL
20140528 OTC MONOGRAPH FINAL part352 "Allure Labs, Inc"
TITANIUM DIOXIDE; ZINC OXIDE 20; 186 mg/g; mg/g
62742-4028_6c2cd9ac-b90c-4ef3-8b59-7c4c231f51bd 62742-4028 HUMAN OTC DRUG
SARAH CHAPMAN London SKINESIS Dynamic Defence Concentrate Anti-Ageing Day Cream
SPF 15 "OCTYL METHOXYCINNAMATE , OCTYL SALICYLATE, OXYBENZONE, AND AVOB
ENZONE" CREAM TOPICAL 20100504 OTC MONOGRAPH FINAL part352
"Allure Labs, Inc." AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 20; 50;
50; 30 mg/mL; mg/mL; mg/mL; mg/mL
62742-4029_d112300c-a0c7-4ae0-9a3d-835d817db48c 62742-4029 HUMAN OTC DRUG
SARAH CHAPMAN London SKINESIS Dynamic Defence Anti-Ageing Day SPF 15
"OCTYL METHOXYCINNAMATE , OCTYL SALICYLATE, OXYBENZONE, AND AVOBENZONE" CREAM
c." AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 20; 50; 50; 30 mg/mL; m
g/mL; mg/mL; mg/mL
62742-4030_04dd129a-7c7b-42a0-8803-dbdda59396de 62742-4030 HUMAN OTC DRUG
"DermaQuest TM Skin Therapy, Breathable Coverage TM Mineral Foundation SPF-30, D
ermaMinerals TM" Zinc Oxide and Titanium Dioxide CREAM TOPICAL
20091001 OTC MONOGRAPH NOT FINAL part352 "Allure Labs, Inc."
TITANIUM DIOXIDE; ZINC OXIDE 48; 58 mg/mL; mg/mL
62742-4033_d9119131-1bda-4895-9d5a-98500f94cc80 62742-4033 HUMAN OTC DRUG
AGELESS Total Skin Bleaching Serum HYDROQUINONE LIQUID TOPICAL
20100101 OTC MONOGRAPH FINAL part358 "Allure Labs, Inc."
HYDROQUINONE 20 mg/mL
62742-4034_fc86ed15-9e81-4407-9c43-2c79a1e6d057 62742-4034 HUMAN OTC DRUG
CLEAR CELL Medicated Acne Scrub Benzoyl Peroxide CREAM TOPICAL
BENZOYL PEROXIDE 30 mg/mL
62742-4035_850ae55b-b7fb-47fb-bc41-0e93766c5038 62742-4035 HUMAN OTC DRUG
CLEAR CELL Medicated Acne "Benzoyl Peroxide, Salicylic Acid"
LOTION TOPICAL 20100101 OTC MONOGRAPH FINAL part333 "Allure
Labs, Inc." BENZOYL PEROXIDE; SALICYLIC ACID 50; 30 mg/mL; mg/mL
62742-4036_2c2af16e-4a6c-436b-bcef-ff531e8f908f 62742-4036 HUMAN OTC DRUG
AGELESS Total Rejuvenating Hand "Octinoxate, Octisalate, Avobenzone, Oct
part352 "Allure Labs, Inc." AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE
20; 75; 50; 20 mg/mL; mg/mL; mg/mL; mg/mL
62742-4037_cea5b90c-cb67-4803-910e-625cba66ff37 62742-4037 HUMAN OTC DRUG
SUN Solar Defense Hydrating "Zinc Oxide, Ethylhexyl Methoxycinnamate
, Benzophenone, Ethylhexyl Salicylate" CREAM TOPICAL 20100101
OTC MONOGRAPH FINAL part352 "Allure Labs, Inc." OCTINOXATE; OCTISALATE;
OXYBENZONE; ZINC OXIDE 75; 50; 30; 50 mg/mL; mg/mL; mg/mL; mg/mL
62742-4038_4eca3569-57ff-4766-833a-e74496eb2969 62742-4038 HUMAN OTC DRUG
SUN Solar Defense Organic SPF30 Zinc Oxide CREAM TOPICAL 20100101
OTC MONOGRAPH FINAL part352 "Allure Labs, Inc." ZINC OXIDE 190
mg/mL
62742-4039_1f4eca23-2fe7-4ba0-8e19-7923e510efa8 62742-4039 HUMAN OTC DRUG
SUN Solar Defense Oil-free Gel SPF 15 "Titanium Dioxide, Ethylhexyl Me
thoxycinnamate, Benzophenone-3" CREAM TOPICAL 20100101 OTC MONO
GRAPH FINAL part352 "Allure Labs, Inc." OCTINOXATE; OXYBENZONE; TITANIUM
DIOXIDE 75; 30; 16 mg/mL; mg/mL; mg/mL
62742-4040_e091db7c-bb5c-4180-a20b-67f7bd20125f 62742-4040 HUMAN OTC DRUG
SUN Solar Defense Oil-free SPF 30 Zinc Oxide GEL TOPICAL
ZINC OXIDE 186 mg/mL
62742-4041_9bdd2920-7c83-4fa7-83d9-c85a69e7e9e0 62742-4041 HUMAN OTC DRUG
SUN Tinted Solar Defense Organic SPF 30 Zinc Oxide CREAM TOPICAL
ZINC OXIDE 170 mg/mL
62742-4042_c7853422-d511-4d01-b8fb-577cab24e80b 62742-4042 HUMAN OTC DRUG
Clear Cell Salicylic Clarifying Pads Salicylic Acid LIQUID TOPICAL
62742-4043_86dde41e-2909-4f02-a32c-01b8eac550fe 62742-4043 HUMAN OTC DRUG
Clear Cell Salicylic Clarifying Tonic Salicylic Acid and Glycolic Acid
LIQUID TOPICAL 20100101 OTC MONOGRAPH FINAL part333 "Allure
Labs, Inc." GLYCOLIC ACID; SALICYLIC ACID 50; 30 mg/mL; mg/mL
62742-4044_fc49cd9b-0e3f-4a43-acd9-1fcd12912f78 62742-4044 HUMAN OTC DRUG
Clear Cell Medicated Acne Masque Salicylic Acid CREAM TOPICAL
62742-4045_8362fe8b-006d-46bd-a031-d4945a4ca543 62742-4045 HUMAN OTC DRUG
Clear Cell Cleanser Salicylic Acid GEL TOPICAL 20100101
OTC MONOGRAPH FINAL part333 "Allure Labs, Inc." SALICYLIC ACID 30
mg/mL
62742-4046_e379ec77-67e5-4867-9f91-b2add725aa16 62742-4046 HUMAN OTC DRUG
Image MD Lightening Rx Hydroquinone CREAM TOPICAL 20100101
OTC MONOGRAPH FINAL part358 "Allure Labs, Inc." HYDROQUINONE 40
mg/mL
62742-4047_e657a245-4cb4-4b20-a54c-358bd8020cd9 62742-4047 HUMAN OTC DRUG
No Foundation SPF 30 Zinc Oxide and Titanium Dioxide CREAM TOPICAL
62742-4048_fbdbe9ea-323a-4651-b480-28864dc02675 62742-4048 HUMAN OTC DRUG
62742-4049_d602176d-bde5-462c-bb52-714baf35a214 62742-4049 HUMAN OTC DRUG
More Than Moisture SPF 30 Zinc Oxide CREAM TOPICAL 20100101
OTC MONOGRAPH FINAL part352 "Allure Labs, Inc." ZINC OXIDE 105
mg/mL
62742-4050_2277495d-ecbd-44de-84cd-c822b80275cd 62742-4050 HUMAN OTC DRUG
Acne TX Mask Benzoyl Peroxide CREAM TOPICAL 20100101
OTC MONOGRAPH FINAL part333 "Allure Labs, Inc." BENZOYL PEROXIDE
25 mg/mL
62742-4051_9ff762a4-f617-49f4-b8fa-07a39880c4ff 62742-4051 HUMAN OTC DRUG
Dermaquest Skin Therapy Post-Skin Resurfacing Balm Hydrocortisone
CREAM TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part348 "Allure
Labs, Inc." HYDROCORTISONE 10 mg/mL
62742-4052_c54081b5-aa9f-4b30-a94a-7a29082d490f 62742-4052 HUMAN OTC DRUG
Dermaquest Skin Therapy Solar Protection SPF 15 Zinc Oxide CREAM
c." ZINC OXIDE 95 mg/mL
62742-4053_ac4da00a-cc70-4ef2-a4b1-c3a6a704c8d4 62742-4053 HUMAN OTC DRUG
Dermaquest Skin Therapy Daily Moisturizing SPF 15 Zinc Oxide
LOTION TOPICAL 20100101 OTC MONOGRAPH FINAL part352 "Allure
Labs, Inc." ZINC OXIDE 95 mg/mL
62742-4054_b488e143-c279-4cd5-b551-461a729bcda6 62742-4054 HUMAN OTC DRUG
Kid Safe Screen Zinc Oxide CREAM TOPICAL 20100901
OTC MONOGRAPH NOT FINAL part352 "Allure Labs, Inc." ZINC OXIDE 200
mg/mL
62742-4055_5ccb438c-b09b-4e92-a28a-c2fb1b28d462 62742-4055 HUMAN OTC DRUG
Moisturizing Face Screen Medium Tint SPF 30 Zinc Oxide CREAM
TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 "Allure Labs, In
62742-4056_67912097-334d-4f03-80a8-393bd34fefa8 62742-4056 HUMAN OTC DRUG
Moisturizing Face Screen SPF 30 Zinc Oxide CREAM TOPICAL 20100901
OTC MONOGRAPH NOT FINAL part352 "Allure Labs, Inc." ZINC OXIDE 200
mg/mL
62742-4057_f603a589-bea4-4407-9607-f969830d2af7 62742-4057 HUMAN OTC DRUG
Moisturizing Face Screen Light Tint SPF 30 Zinc Oxide CREAM
TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 "Allure Labs, In
62742-4058_a268c744-6523-47b0-9f3c-d53ebdf7b904 62742-4058 HUMAN OTC DRUG
Anti-Bacterial Wash with Exfoliating Beads for Blemish skin Benzoyl
Peroxide GEL TOPICAL 20100101 OTC MONOGRAPH NOT FINAL
part333D "Allure Labs, Inc." BENZOYL PEROXIDE 25 mg/mL
62742-4061_2e3befa1-ca89-42df-9933-d2403b24a6e3 62742-4061 HUMAN OTC DRUG
62742-4066_2032c3e0-9ada-4654-a245-53577d1243ef 62742-4066 HUMAN OTC DRUG
No Foundation Foundation No.2 Light to Medium Zinc Oxide and Titanium
Dioxide CREAM TOPICAL 20140414 OTC MONOGRAPH FINAL part352
"Allure Labs, Inc." TITANIUM DIOXIDE; ZINC OXIDE 32; 122 mg/mL; mg/mL
55531-001_abd6bda9-3994-4215-8e55-6c325f5c5516 55531-001 HUMAN OTC DRUG
Medicated Green Oil "MENTHOL, METHYL SALICYLATE" OIL TOPICAL
20130702 OTC MONOGRAPH NOT FINAL part348 Allways Health-Care Corp
oration Limited MENTHOL; METHYL SALICYLATE 160; 300 mg/100mL; mg/100
mL
52427-272_ad28dcef-70a1-9000-3f8c-e0d3f4e1a7f1 52427-272 HUMAN PRESCRIPTI
ON DRUG Naprelan Naproxen Sodium "TABLET, FILM COATED, EXTENDED R
ELEASE" ORAL 20140117 NDA NDA020353 ALMATICA PHARMA
INC. NAPROXEN SODIUM 375 mg/1 "Cyclooxygenase Inhibitors [MoA],Nonster
matory Drug [EPC]"
matory Drug [EPC]"
matory Drug [EPC]"
52427-285_039c8f9c-f410-a898-e101-b8eac83f2d97 52427-285 HUMAN PRESCRIPTI
ON DRUG Macrobid Nitrofurantoin Monohydrate/Macrocrystalline
CAPSULE ORAL 20110531 NDA NDA020064 Almatica Pharma
Inc. NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE 25; 75 mg/1; mg/1
"Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Ant
ibacterial [EPC],Nitrofurans [Chemical/Ingredient]"
52427-286_54e6a03c-8b46-d0c4-d89c-8fc140df29ff 52427-286 HUMAN PRESCRIPTI
ON DRUG Macrodantin Nitrofurantion crystals Macrodantin CAPSULE ORAL
20100927 NDA NDA016620 Almatica Pharma Inc. NITROFUR
ANTOIN 25 mg/1 "Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/In
gredient]"
gredient]"
gredient]"
0311-0585_acf2f8d5-3582-4601-9ceb-dee438023b29 0311-0585 HUMAN OTC DRUG
Almay Sensitive Skin Antiperspirant - Deodorant Roll-On Fragrance Free ALUMINUM
SESQUICHLOROHYDRATE LIQUID TOPICAL 20131215 OTC MONOGRAPH FI
NAL part350 "Almay, Inc" ALUMINUM SESQUICHLOROHYDRATE 0.25 g/mL
61477-101_95b1485e-961b-405d-a889-740553edb245 61477-101 HUMAN OTC DRUG
ALOE ICE SUNBURN RELIEF JELLY LIDOCAINE HYDROCHLORIDE GEL TOPICAL
20140224 OTC MONOGRAPH NOT FINAL part348 "Aloe Care International
, LLC" LIDOCAINE HYDROCHLORIDE 2 g/100mL
61477-201_229ecf20-6297-4efa-a2ed-0af94c6e1bf0 61477-201 HUMAN OTC DRUG
ALOE ICE SPF 20 "AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE"
LOTION TOPICAL 20140224 OTC MONOGRAPH NOT FINAL part352 "Aloe Ca
re International, LLC" AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2; 4; 5;
3 g/100mL; g/100mL; g/100mL; g/100mL
61477-203_715a6523-282a-4a5e-b0bf-bffff3d5f5db 61477-203 HUMAN OTC DRUG
ALOE ICE SPF 50 "AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBEN
"Aloe Care International, LLC" AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE;
OCTOCRYLENE 3; 5; 6; 5; 10 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
61477-205_11fe2359-3fea-48d0-b79a-7e8288e1fd5d 61477-205 HUMAN OTC DRUG
ALOE UP LIL KIDS SPF 50 "AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE,
part352 "Aloe Care International, LLC" AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTI
SALATE; OCTOCRYLENE 3; 5; 6; 5; 10 g/100mL; g/100mL; 1/100mL; g/100mL; 1/10
0mL
61477-206_ceea504c-bd03-4956-ac6f-3ad7431d45ac 61477-206 HUMAN OTC DRUG
ALOE UP LIL KIDS CONTINUOUS SUNSCREEN SPF 50 "AVOBENZONE, HOMOSALATE, OCTISAL
ATE, OCTOCRYLENE, OXYBENZONE" SPRAY TOPICAL 20140224 OTC MONO
GRAPH NOT FINAL part352 "Aloe Care International, LLC" AVOBENZONE; HOMOSALATE;
OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 2.75; 4 g/100mL; g/100mL
; g/100mL; g/100mL; 1/100mL
61477-207_7a11e8c7-0894-43e4-b833-9e03707f7359 61477-207 HUMAN OTC DRUG
ALOE UP PRO 15 "AVOBENZONE, OCTISALATE, OCTOCRYLENE" SPRAY TOPICAL
20140224 OTC MONOGRAPH NOT FINAL part352 "Aloe Care International
, LLC" AVOBENZONE; OCTISALATE; OCTOCRYLENE 2; 5; 1.85 g/100mL; g/100mL
; g/100mL
61477-208_40958abf-4714-4a95-8ea4-ea83f482ad92 61477-208 HUMAN OTC DRUG
ALOE UP PRO SPF 30 ULTRA SPORT SUNSCREEN "AVOBENZONE, HOMOSALATE, OCTISAL
ATE, OCTOCRYLENE" LOTION TOPICAL 20140224 OTC MONOGRAPH NO
T FINAL part352 "Aloe Care International, LLC" AVOBENZONE; HOMOSALATE; OCTISALA
TE; OCTOCRYLENE 3; 10; 5; 3.5 g/100mL; g/100mL; g/100mL; g/100mL
61477-209_4e90c283-1fba-4559-863d-d8538d76479f 61477-209 HUMAN OTC DRUG
ALOE UP PRO 30 CONTINUOUS SUNSCREEN "AVOBENZONE, HOMOSALATE, OCTISALATE, OCT
OCRYLENE, OXYBENZONE" SPRAY TOPICAL 20140224 OTC MONOGRAPH NO
TE; OCTOCRYLENE; OXYBENZONE 3; 7.5; 5; 2.75; 2 g/100mL; g/100mL; g/100m
L; g/100mL; 1/100mL
61477-210_9194139a-3a2f-4a8a-95ee-67a1d8423ee4 61477-210 HUMAN OTC DRUG
ALOE UP PRO SPF 50 ADVANCED FORMULA ULTRA SPORT SUNSCREEN "AVOBENZONE, HOM
OSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE" LOTION TOPICAL 20140224
OTC MONOGRAPH NOT FINAL part352 "Aloe Care International, LLC" AVOBENZONE; HOMO
SALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 3; 5; 6; 5; 10 g/100mL; g/100mL
; 1/100mL; g/100mL; g/100mL
61477-211_434dc135-c15d-4659-b09d-57ca52542eee 61477-211 HUMAN OTC DRUG
ALOE UP PRO 50 CONTINUOUS SUNSCREEN "AVOBENZONE, HOMOSALATE, OCTISALATE, OCT
OCRYLENE, OXYBENZONE" SPRAY TOPICAL 20140224 OTC MONOGRAPH NO
TE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 2.75; 4 g/100mL; g/100mL; g/100m
L; g/100mL; 1/100mL
61477-213_6c783b07-f206-4e61-87ef-28472af86147 61477-213 HUMAN OTC DRUG
ALOE UP SUNSCREEN SPF 50 "AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
, OCTINOXATE" LOTION TOPICAL 20140224 OTC MONOGRAPH NOT FINAL
part352 "Aloe Care International, LLC" AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTI
SALATE; OCTOCRYLENE 3; 5; 6; 5; 10 g/100mL; g/100mL; g/100mL; g/100mL; 1/10
0mL
61477-214_79ce1137-5081-4d95-a1db-e7888d0296fc 61477-214 HUMAN OTC DRUG
ALOE UP NATURAL LIP ICE SUNSCREEN "OCTINOXATE, OXYBENZONE"
LIPSTICK TOPICAL 20140224 OTC MONOGRAPH NOT FINAL part352
"Aloe Care International, LLC" OCTINOXATE; OXYBENZONE 2; 4.5 g/100g; 1/100g
61477-215_abd00ab9-675a-4d0f-95cc-a2535d1221cc 61477-215 HUMAN OTC DRUG
ALOE UP MEDICATED LIP BALM SPF 30 "HOMOSALATE, MERADIMATE, OCTINOXATE, OXY
BENZONE" LIPSTICK TOPICAL 20140224 OTC MONOGRAPH NO
T FINAL part352 "Aloe Care International, LLC" HOMOSALATE; MERADIMATE; OCTINOXA
TE; OXYBENZONE 6; 4; 7.5; 5 1/100g; 1/100g; g/100g; 1/100g
61477-216_0b9a4b5d-18a6-4454-9c4f-a0217a51775f 61477-216 HUMAN OTC DRUG
ALOE UP DARK TANNING OIL SPF 4 CONTINUOUS SUNSCREEN "OCTINOXATE, OXYBENZONE"
SPRAY TOPICAL 20140224 OTC MONOGRAPH NOT FINAL part352 "Aloe Ca
re International, LLC" OCTINOXATE; OXYBENZONE 2; 2 g/100mL; 1/100mL
11697-199_df6b35ae-36cd-4b2c-8a15-817c6eb970a8 11697-199 HUMAN OTC DRUG
Aloe Sunscreen Homosalate LOTION TOPICAL 20110406
OTC MONOGRAPH NOT FINAL part352 "Aloe Vera of America, Inc." AVOBENZONE; ENSU
LIZOLE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3.54; 3.54; 1.18; 5.9; 3.922
mL/118mL; mL/118mL; mL/118mL; mL/118mL; mL/118mL
11697-318_47e35750-9678-4cd2-af27-e00fcfd4d3e4 11697-318 HUMAN OTC DRUG
Forever Hand Sanitizer Hand Sanitizer Alcohol GEL TOPICAL 20100816
OTC MONOGRAPH NOT FINAL part333E "Aloe Vera of America, Inc." ALCOHOL
36.58 mL/59mL
11697-319_c763a840-7e8e-43ee-8941-d2bd4a6e6737 11697-319 HUMAN OTC DRUG
Aloe Sunscreen Homosalate SPRAY TOPICAL 20100816
OTC MONOGRAPH NOT FINAL part352 "Aloe Vera of America, Inc." AVOBENZONE; ENSU
LIZOLE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 5.34; 7.12; 17.8; 8.9; 4.9662
mL/178mL; mL/178mL; mL/178mL; mL/178mL; mL/178mL
11697-371_7b0aee80-cf83-4852-b531-3aba12fcc4b3 11697-371 HUMAN OTC DRUG
Flawless by Sonya Aloe BB Creme Nude TITANIUM DIOXIDE CREAM TOPICAL
20140112 OTC MONOGRAPH NOT FINAL part352 "Aloe Vera of America, I
nc." TITANIUM DIOXIDE 3.15 g/45g
11697-373_40f0d8fc-d934-4156-8f49-7ec4e266c6b6 11697-373 HUMAN OTC DRUG
Flawless by Sonya Aloe BB Creme Cocoa Titanium Dioxide CREAM TOPICAL
20130301 OTC MONOGRAPH NOT FINAL part352 "Aloe Vera of America, I
nc." TITANIUM DIOXIDE 1.35 g/45g
11697-462_6c629c19-639c-4c7f-a69f-e7fbbce5cee9 11697-462 HUMAN OTC DRUG
Forever Sun Lips Sunscreen LIPSTICK TOPICAL 20140425
OTC MONOGRAPH NOT FINAL part352 "Aloe Vera of America, Inc." AVOBENZONE; HOMO
SALATE; OCTISALATE; OCTOCRYLENE; PETROLATUM .1275; .425; .2125; .1186; 1.615
g/4.25g; g/4.25g; g/4.25g; g/4.25g; g/4.25g
65447-050_0ab6b7a0-0a50-4c11-bfbc-46ab66be5d28 65447-050 HUMAN OTC DRUG
Cellular Day Defense Firming SPF 25 "zinc oxide, oxybenzone, and oct
inoxate" CREAM TOPICAL 20111015 OTC MONOGRAPH NOT FINAL
part352 Aloette Cosmetics Inc. OCTINOXATE; OXYBENZONE; ZINC OXIDE 7.5; 3;
5 g/100g; g/100g; g/100g
65257-001_3a828edd-db47-45ad-aed5-66e7f4461dcf 65257-001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS AlpinAire Healthcare OXYGEN 99 L/100L
66552-0001_7ced7f77-b265-41c9-9a61-921172f46632 66552-0001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS Alpine Home Medical Equipment OXYGEN 99
L/100L
75939-9876_410a54c1-cdb4-465b-83f6-9986185f2ff1 75939-9876 HUMAN OTC DRUG
Liqufruta GUAIFENESIN SYRUP ORAL 20110101
OTC MONOGRAPH FINAL part341 Alston Garrard & Co GUAIFENESIN 50
mg/5mL
75939-9876_ffde5fe1-c84d-4ccf-a417-36ff56b47790 75939-9876 HUMAN OTC DRUG
Liqufruta GUAIFENESIN SYRUP ORAL 20110101
OTC MONOGRAPH FINAL part341 Alston Garrard & Co GUAIFENESIN 50
mg/5mL
59390-036_9c9dbeb1-1b8e-4e93-b1a1-d65667a11964 59390-036 HUMAN OTC DRUG
12 Hour Nasal Oxymetazoline Hydrochloride SPRAY NASAL 20010601
OTC MONOGRAPH FINAL part341 Altaire Pharmaceuticals Inc. OXYMETAZOLINE HY
DROCHLORIDE 0.05 g/100mL
59390-140_1419e0b7-cb1e-48fd-ab83-edfa70ddd693 59390-140 HUMAN PRESCRIPTI
ON DRUG Ofloxacin ophthalmic Ofloxacin SOLUTION OPHTHALM
IC 20130531 ANDA ANDA202692 Altaire Pharmaceuticals
Inc. OFLOXACIN 3 mg/mL "Quinolone Antimicrobial [EPC],Quinolone
59390-177_8de55300-9137-4213-bd54-74d93dee9299 59390-177 HUMAN OTC DRUG
Naphazoline HCI And Pheniramine Maleate "NAPHAZOLINE HYDROCHLORIDE , PHE
NIRAMINE MALEATE" SOLUTION/ DROPS OPHTHALMIC 20101006
ANDA ANDA078208 Altaire Pharmaceuticals Inc. NAPHAZOLINE HYDROCHLORID
E; PHENIRAMINE MALEATE .027; .315 mL/100mL; mL/100mL
59390-181_50f34194-b263-4241-a61b-94d4a615a543 59390-181 HUMAN PRESCRIPTI
ON DRUG ALTACAINE Tetracaine Hydrochloride SOLUTION
OPHTHALMIC 20020201 UNAPPROVED DRUG OTHER Altaire
Pharmaceuticals Inc. TETRACAINE HYDROCHLORIDE 5 mg/mL "Ester L
ocal Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE]"
59390-192_9fe4d614-4a9c-49d9-98b8-79e6218bdb40 59390-192 HUMAN PRESCRIPTI
ON DRUG HOMATROPINE HYDROBROMIDE OPHTHALMIC Homatropine Hydrobromide
Altaire Pharmaceuticals Inc. HOMATROPINE HYDROBROMIDE 50 mg/mL
"Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA]"
59390-206_2f3d7acd-3890-4aff-bf27-539b7ba436f8 59390-206 HUMAN PRESCRIPTI
ON DRUG Fluorescein Sodium and Benoxinate Hydrochloride Fluorescein Sodi
um and Benoxinate Hydrochloride SOLUTION OPHTHALMIC 20000621
UNAPPROVED DRUG OTHER Altaire Pharmaceuticals Inc. BENOXINATE HYDRO
CHLORIDE; FLUORESCEIN SODIUM 4; 2.5 mg/mL; mg/mL "Diagnostic Dye [EPC],Dy
es [MoA]"
59390-205_aad82660-736c-4cbb-9426-c8651dec3718 59390-205 HUMAN PRESCRIPTI
ON DRUG Fluorecein sodium and Proparacaine Hydrochloride Fluorece
in sodium and Proparacaine Hydrochloride Opthahalmic Solution SOLUTION/ DROPS
OPHTHALMIC 19890330 UNAPPROVED DRUG OTHER "Altaire
Pharmaceuticals, Inc." FLUORESCEIN SODIUM; PROPARACAINE HYDROCHLORIDE .5; 2.5
mg/mL; mg/mL "Diagnostic Dye [EPC],Dyes [MoA],Local Anesthesia [PE],Local Ane
sthetic [EPC]"
64097-0001_8def91d4-8ccf-457f-96c5-f643130ca8a5 64097-0001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS Alternacare Home Health Services OXYGEN
99.5 L/100L
49304-0013_90d29cd7-aa5f-48c2-9f65-62a2a53fbf50 49304-0013 HUMAN OTC DRUG
Energize "Aralia QuinQuefolia, Avena Sativa, Kali Phosphoricum, P
hosphoricum Acidum, Picricum Acidum, Zingiber Officinale" LIQUID ORAL
20131002 UNAPPROVED HOMEOPATHIC Alternate Pharmacy
"AMERICAN GINSENG; AVENA SATIVA FLOWERING TOP; GINGER; PHOSPHORIC ACID; PICRIC A
CID; POTASSIUM PHOSPHATE, DIBASIC" 6; 3; 3; 6; 6; 12 [hp_X]/mL; [hp_X
]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
53163-101_e5d7a636-0d7e-46a6-baa1-149e464360ae 53163-101 HUMAN OTC DRUG
Altipres-B "BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE,
PHENYLEPHRINE HYDROCHLORIDE" LIQUID ORAL 20121101 OTC MONO
GRAPH FINAL part341 Alternative Pharmacal Corporation BROMPHENIRAMINE
0 mg/5mL; mg/5mL; mg/5mL
53163-103_1481c32e-8a0f-4de0-a26e-bb40876a6068 53163-103 HUMAN OTC DRUG
Altipres Pediatric "Dextromethorphan HBr, Guaifenesin, Phenylephrin
e HCl" LIQUID ORAL 20130501 OTC MONOGRAPH FINAL part341
Alternative Pharmacal Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENES
IN; PHENYLEPHRINE HYDROCHLORIDE 5; 75; 2.5 mg/5mL; mg/5mL; mg/5mL
53163-104_36243788-6b37-48b1-b7ce-8db89ac3ccce 53163-104 HUMAN OTC DRUG
Altipres "Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl"
LIQUID ORAL 20130501 OTC MONOGRAPH FINAL part341 Alternat
ive Pharmacal Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHEN
YLEPHRINE HYDROCHLORIDE 10; 200; 5 mg/5mL; mg/5mL; mg/5mL
53163-106_a8d5f774-c8ba-44b8-a73d-9f109a378d60 53163-106 HUMAN OTC DRUG
Igualtuss "Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl"
53163-251_a99931b2-8fe8-451d-8151-937201cce40e 53163-251 HUMAN OTC DRUG
Altidome DMX "Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl"
49304-0001_1dc4a436-7d10-499c-ac67-f47663ab3a4f 49304-0001 HUMAN OTC DRUG
Male Energy "Dehydroepiandrosterone, Sabal serrulata, Setotonin, Orc
hitinum (suis), Pituitary (suis), Thyroidinum (suis), Conium maculatum, Testoste
rone," LIQUID ORAL 20120507 UNAPPROVED HOMEOPATHIC
Alternative Pharmacy "CONIUM MACULATUM FLOWERING TOP; PRASTERONE; SAW PALMETT
O; SEROTONIN; SUS SCROFA PITUITARY GLAND; SUS SCROFA TESTICLE; TESTOSTERONE; THY
ROID, PORCINE" 12; 6; 6; 6; 8; 8; 12; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL;
[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
49304-0002_7071dbcf-470c-4138-9831-56fd6cd15a45 49304-0002 HUMAN OTC DRUG
Happy Happy "Aurum Metallicum, Lithium Carbonicum, Serotonin"
LIQUID ORAL 20121022 UNAPPROVED HOMEOPATHIC Alternat
ive Pharmacy GOLD; LITHIUM CARBONATE; SEROTONIN HYDROCHLORIDE 12; 6; 1
2 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
49304-0003_96a2a02c-b341-4da1-8363-7fd38bc94c0e 49304-0003 HUMAN OTC DRUG
Happy Bones "Boron, Calcarea carbonica, Calcarea fluorica, Calcarea
hypophosphorosa, Calcarea phosphorica, Hekla lava, Mezereum, Natrum phosphoricum
, Silicea, Symphytum oficinale, Urtica dioica, Vanadium metallicum," LIQUID
ORAL 20121018 UNAPPROVED HOMEOPATHIC Alternative Phar
macy "BORON; CALCIUM FLUORIDE; CALCIUM HYPOPHOSPHITE; COMFREY ROOT; DAPHNE ME
ZEREUM BARK; HEKLA LAVA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SILICON DIOXIDE;
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; TRIBASIC CALCIUM PHOSPHATE; URTICA DIO
ICA; VANADIUM" 12; 8; 6; 6; 6; 12; 30; 12; 6; 8; 4; 12 [hp_X]/mL; [hp_X]/mL; [h
p_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X
]/mL; [hp_X]/mL; [hp_X]/mL
49304-0004_d7d62cf3-c32b-4fb9-abd8-e6d5315275d1 49304-0004 HUMAN OTC DRUG
Flexible "Arnica montana, Causticum, Colchicum autumnale, Hyperic
um perforatum, Kalmia Latifolia, Phytolacca decandra, Rhododendrom chrysanthum,"
ive Pharmacy ARNICA MONTANA; CAUSTICUM; COLCHICUM AUTUMNALE BULB; HYPERICUM P
ERFORATUM; KALMIA LATIFOLIA LEAF; PHYTOLACCA AMERICANA ROOT; RHODODENDRON AUREUM
LEAF; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF; URTICA URENS
; ZINC 6; 6; 6; 6; 12; 6; 4; 4; 6; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL;
[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [h
p_X]/mL
49304-0005_8b2fd8dd-9afe-4423-9318-937f7b429199 49304-0005 HUMAN OTC DRUG
Cold and Flu Solution "Aconitum Napellus, Belladonna, Echinacea, Eupat
orium Perfoliatum, Gelsemium Sempervirens, Ferrum Phosphoricum, Anas Barbariae,
Hepatis Et Cordis Extractum" LIQUID ORAL 20130910 UNAPPROV
ED HOMEOPATHIC Alternative Pharmacy "ACONITUM NAPELLUS; ATROPA BELLA
DONNA; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; ECHINACEA, UNSPECIFIED; EUPATORI
UM PERFOLIATUM FLOWERING TOP; FERRUM PHOSPHORICUM; GELSEMIUM SEMPERVIRENS ROOT"
3; 3; 200; 3; 3; 4; 3 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [
hp_C]/mL; [hp_C]/mL
49304-0006_a79e6e2e-2d65-4ab5-9231-4b1a4d996c72 49304-0006 HUMAN OTC DRUG
Quiet Calm "Ammonium Bromatum, Avena Sativa, Chamomilla, Coffea Cru
da, Gelsemium Sempervirens, Phosphoricum Acidum" LIQUID ORAL 20130306
UNAPPROVED HOMEOPATHIC Alternative Pharmacy AMMONIUM BROMIDE; ARABIC
A COFFEE BEAN; AVENA SATIVA FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; MATRICAR
IA RECUTITA; PHOSPHORIC ACID; TRYPTOPHAN; VALERIAN 3; 6; 1; 6; 6; 6; 6; 30
[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp
_X]/mL
49304-0007_082f9e0b-5c1a-478c-beb4-107f5625b4f5 49304-0007 HUMAN OTC DRUG
High Potency Heal Grief "Ignatia Amara, Natrum Muriaticum, Staphysagria"
ive Pharmacy DELPHINIUM STAPHISAGRIA SEED; SODIUM CHLORIDE; STRYCHNOS IGNATII
SEED 200; 200; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
49304-0008_921e1d20-90a3-4f87-bd02-6c0081145c2e 49304-0008 HUMAN OTC DRUG
Nighty Nite "Grindelia, Melatonin, Passiflora Incarnata" LIQUID
ORAL 20130424 UNAPPROVED HOMEOPATHIC Alternative Phar
macy GRINDELIA HIRSUTULA FLOWERING TOP; MELATONIN; PASSIFLORA INCARNATA FLOWE
RING TOP 6; 12; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
49304-0009_ee7dc06c-85c6-4b92-8f82-f57919cc6b91 49304-0009 HUMAN OTC DRUG
ADRENAL ENERGY "Berberis Vulgaris, Agaricus Muscarius, Urtica Urens, Gl
andula Suprarenalis Bovinum, Echinacea, Atropinum Sulphuricum, Ceanothus America
nus" LIQUID ORAL 20130809 UNAPPROVED HOMEOPATHIC
Alternative Pharmacy "AMANITA MUSCARIA FRUITING BODY; ATROPINE SULFATE; BERBE
RIS VULGARIS ROOT BARK; BOS TAURUS ADRENAL GLAND; BOS TAURUS SPLEEN; CEANOTHUS A
MERICANUS LEAF; ECHINACEA, UNSPECIFIED; URTICA URENS" 3; 12; 3; 8; 8; 12; 12;
3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]
/mL; [hp_X]/mL
49304-0010_4892c6ea-ea0b-4500-a279-1006801c9e96 49304-0010 HUMAN OTC DRUG
UR IN CONTROL "Apis Mellifica, Argentum Nitricum, Belladonna, Canthari
s, Causticum, Equsetum Arvense, Petroselinum Sativum, Pulsatilla, Sarsaparilla,
Terebinthina" LIQUID ORAL 20130821 UNAPPROVED HOMEOPATHIC
Alternative Pharmacy APIS MELLIFERA; ATROPA BELLADONNA; CAUSTICUM; EQUISETUM
ARVENSE TOP; LYTTA VESICATORIA; PETROSELINUM CRISPUM; PULSATILLA VULGARIS; SARSA
PARILLA; SILVER NITRATE; TURPENTINE OIL 6; 4; 8; 6; 6; 8; 6; 6; 6; 6 [hp_X]/m
L; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL;
[hp_X]/mL; [hp_X]/mL
49304-0011_52739b96-46d8-4166-a655-a478be6a73b4 49304-0011 HUMAN OTC DRUG
Stay Well "Argentum Nitricum, Baptisia Tinctoria, Echinacea, Echin
acea Purpurea, Galium Aparine, Phosphorus, Pulstilla, Sulphur, Thuma Occidentali
s, Thymus Serpyllum" LIQUID ORAL 20130821 UNAPPROVED HOMEO
PATHIC Alternative Pharmacy "BAPTISIA TINCTORIA; ECHINACEA PURPUREA;
ECHINACEA, UNSPECIFIED; GALIUM APARINE; PHOSPHORUS; PULSATILLA VULGARIS; SILVER
NITRATE; SULFUR; THUJA OCCIDENTALIS LEAF; THYMUS SERPYLLUM" 6; 3; 6; 6; 6; 6
; 6; 12; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
49304-0012_3ed1caa2-68b9-4773-8f06-f99fe25bfd7a 49304-0012 HUMAN OTC DRUG
Thyroid Rhythm "Adrenalinum, Calarea Carbonica, Calcarea Fluorica, Calc
area Iodata, Ferrum Iodatum, Fucus Vesiculosus, Iodium, Kali Iodatum, Naturm Mur
iaticum" LIQUID ORAL 20131003 UNAPPROVED HOMEOPATHIC
Alternative Pharmacy "BOS TAURUS PITUITARY GLAND; BOS TAURUS SPLEEN; BOS TAUR
US THYMUS; CALCIUM FLUORIDE; CALCIUM IODIDE; EPINEPHRINE; FERROUS IODIDE; FUCUS
VESICULOSUS; IODINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM IODIDE; SO
DIUM CHLORIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA THYROID"
6; 6; 6; 8; 6; 6; 8; 6; 9; 30; 6; 30; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL;
p_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
49304-0014_168698de-198c-449c-a71b-01711b31f383 49304-0014 HUMAN OTC DRUG
Happy Happy not applicable LIQUID ORAL 20140724
UNAPPROVED HOMEOPATHIC Alternative Pharmacy GOLD; LITHIUM CARBONATE;
SEROTONIN HYDROCHLORIDE 12; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
49304-0015_2d19a4f7-9faf-4c52-8fbd-fe4fab43f725 49304-0015 HUMAN OTC DRUG
Stomach Relief not applicable LIQUID ORAL 20140724
UNAPPROVED HOMEOPATHIC Alternative Pharmacy ACTIVATED CHARCOAL; ARSE
NIC TRIOXIDE; ROBINIA PSEUDOACACIA BARK; STRYCHNOS NUX-VOMICA SEED 30; 30;
12; 12 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL
49304-0016_d80fdc5f-2659-4b0b-b9df-52966c11512c 49304-0016 HUMAN OTC DRUG
Trauma Drama not applicable LIQUID ORAL 20140724
UNAPPROVED HOMEOPATHIC Alternative Pharmacy ARNICA MONTANA; ATROPA B
ELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; H
YPERICUM PERFORATUM; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS; RUTA GRAVEOLENS F
LOWERING TOP; TOXICODENDRON PUBESCENS LEAF 30; 6; 6; 6; 30; 6; 6; 12; 6; 6
_X]/mL; [hp_C]/mL; [hp_C]/mL
49304-0017_47a8d661-1deb-4a86-b432-cbf6382d5f6e 49304-0017 HUMAN OTC DRUG
TICKED Not applicable LIQUID ORAL 20140724 UNAPPROV
ED HOMEOPATHIC Alternative Pharmacy ACONITUM NAPELLUS; ARNICA MONTAN
A; BORRELIA BURGDORFERI; CALENDULA OFFICINALIS FLOWERING TOP; EPINEPHRINE; LEDUM
PALUSTRE TWIG; PHYTOLACCA AMERICANA ROOT 30; 30; 12; 3; 8; 12; 3 [hp_X]/m
L; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
49304-0018_ccd9fbab-7033-440e-9f40-519986a609bd 49304-0018 HUMAN OTC DRUG
Happy Heart not applicable LIQUID ORAL 20140724
UNAPPROVED HOMEOPATHIC Alternative Pharmacy ACONITUM NAPELLUS; ARNIC
A MONTANA; GELSEMIUM SEMPERVIRENS ROOT; NITROGLYCERIN; POTASSIUM CARBONATE; RANU
NCULUS BULBOSUS; SELENICEREUS GRANDIFLORUS STEM; SPIGELIA ANTHELMIA; SULFUR
30; 30; 10; 6; 6; 10; 4; 8; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_
X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
63874-087_12c7793d-11c5-4f1b-883b-04e7aed3fb5c 63874-087 HUMAN PRESCRIPTI
ANDA ANDA076286 "Altura Pharmaceuticals, Inc." TIZANIDINE HYDROCHLORIDE
nist [EPC]"
63874-101_2234ef41-dd5f-46b3-aa17-8f8fd30add38 63874-101 HUMAN PRESCRIPTI
ANDA ANDA065291 "Altura Pharmaceuticals, Inc." AMOXICILLIN 250
mg/1
63874-102_2234ef41-dd5f-46b3-aa17-8f8fd30add38 63874-102 HUMAN PRESCRIPTI
ANDA ANDA065291 "Altura Pharmaceuticals, Inc." AMOXICILLIN 500
mg/1
63874-111_b4cebeeb-b014-4e9d-a865-4f09e4473c36 63874-111 HUMAN PRESCRIPTI
ON DRUG Cephalexin Cephalexin CAPSULE ORAL 20100101
ANDA ANDA065215 "Altura Pharmaceuticals, Inc." CEPHALEXIN 250
mg/1
63874-112_b4cebeeb-b014-4e9d-a865-4f09e4473c36 63874-112 HUMAN PRESCRIPTI
ANDA ANDA065215 "Altura Pharmaceuticals, Inc." CEPHALEXIN 500
mg/1
63874-201_1f96e42a-9915-49d9-8971-7d72ec6db64f 63874-201 HUMAN PRESCRIPTI
ON DRUG Propoxyphene and Acetaminophen propoxyphene napsylate and aceta
minophen "TABLET, FILM COATED" ORAL 20100101 ANDA
ANDA074843 "Altura Pharmaceuticals, Inc." ACETAMINOPHEN; PROPOXYPHENE NAPS
YLATE 650; 100 mg/1; mg/1 "Full Opioid Agonists [MoA],Opioid Agoni
st [EPC]" CIV
63874-203_4861231c-7aeb-49d5-9309-4e2855039a78 63874-203 HUMAN PRESCRIPTI
ANDA089971 "Altura Pharmaceuticals, Inc." ACETAMINOPHEN; HYDROCODONE BITAR
CIII
oA]" CIII
CIII
CIII
oA]" CIII
63874-301_feb7a143-ac2f-48fd-a2d1-1475337efacf 63874-301 HUMAN PRESCRIPTI
ANDA ANDA078250 "Altura Pharmaceuticals, Inc." NAPROXEN 250
63874-322_1fbfeaff-19c8-4475-8da3-7e556c7e9104 63874-322 HUMAN PRESCRIPTI
ANDA ANDA078558 "Altura Pharmaceuticals, Inc." IBUPROFEN 400
ANDA ANDA078314 "Altura Pharmaceuticals, Inc." NAPROXEN SODIUM 550
63874-413_66fa987f-47df-49ff-ab90-8b1e2bd3319c 63874-413 HUMAN PRESCRIPTI
ON DRUG Methylprednisolone methylprednisolone TABLET ORAL
20100101 NDA NDA011757 "Altura Pharmaceuticals, Inc."
ANDA ANDA078314 "Altura Pharmaceuticals, Inc." NAPROXEN SODIUM 275
63874-532_48b18a1e-404e-4b1e-b539-94d6993c8a76 63874-532 HUMAN PRESCRIPTI
ON DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET ORAL
20100101 ANDA ANDA076003 "Altura Pharmaceuticals, Inc."
st [EPC]"
63874-553_094625fc-2d69-4268-8c79-7519eafe1051 63874-553 HUMAN PRESCRIPTI
ON DRUG Omeprazole omeprazole "CAPSULE, DELAYED RELEASE"
ORAL 20100101 ANDA ANDA075410 "Altura Pharmaceuticals,
Inc." OMEPRAZOLE 20 mg/1 "Proton Pump Inhibitor [EPC],Proton Pump
63874-607_c445da39-f7f2-46a9-871f-a25f1c0f462f 63874-607 HUMAN PRESCRIPTI
ON DRUG Nabumetone Nabumetone TABLET ORAL 20100101
ANDA ANDA076009 "Altura Pharmaceuticals, Inc." NABUMETONE 500
63874-687_c445da39-f7f2-46a9-871f-a25f1c0f462f 63874-687 HUMAN PRESCRIPTI
ON DRUG Nabumetone Nabumetone TABLET ORAL 20100101
ANDA ANDA076009 "Altura Pharmaceuticals, Inc." NABUMETONE 750
CIII
CIII
52389-639_dcbbc99c-e3f1-4957-8e34-3d4be3385d84 52389-639 HUMAN OTC DRUG
Fungicure Athletes Foot Tolnaftate 1% CREAM TOPICAL 20140326
OTC MONOGRAPH FINAL part333C "Alva-Amco Pharmacal Companies, Inc"
TOLNAFTATE 10 mg/g
52389-117_a495dd69-ce99-4c2e-8187-5e816c68092d 52389-117 HUMAN OTC DRUG
Pep-Back Peak Performance Caffeine "TABLET, FILM COATED"
ORAL 20070328 OTC MONOGRAPH FINAL part340 "Alva-Amco Pharm
acal Companies, Inc." CAFFEINE 200 mg/1
52389-118_c41a5f26-f050-4c31-9c69-1bb46bd611df 52389-118 HUMAN OTC DRUG
Theradent "Calcium acetate, potassium nitrate, potassium phosphate
, sodium fluoride" MOUTHWASH ORAL 20060717 UNAPPROV
ED HOMEOPATHIC "Alva-Amco Pharmacal Companies, Inc." "CALCIUM ACETATE
; POTASSIUM NITRATE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM FLUORIDE" 1; 6; 1;
3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
52389-126_d19348b7-2756-4cec-9502-8f1ff6b139d5 52389-126 HUMAN OTC DRUG
Fungicure for Jock Itch Sepia SOAP TOPICAL 20060423
UNAPPROVED HOMEOPATHIC "Alva-Amco Pharmacal Companies, Inc." SEPIA OF
FICINALIS JUICE 12 [hp_X]/mL
52389-136_5553c6cd-f7f5-4405-b5b1-2773e71fbb43 52389-136 HUMAN OTC DRUG
Diurex Pamabrom "CAPSULE, LIQUID FILLED" ORAL 20000410
OTC MONOGRAPH NOT FINAL part357 "Alva-Amco Pharmacal Companies, Inc." PAMABROM
50 mg/1
52389-153_fd5c1030-6e78-44e5-9dcb-7416d507d1d7 52389-153 HUMAN OTC DRUG
BackAid Max "acetaminophen, pamabrom" "TABLET, FILM COATED" ORAL
19920201 OTC MONOGRAPH NOT FINAL part343 "Alva-Amco Pharmacal Com
panies, Inc." ACETAMINOPHEN; PAMABROM 500; 25 mg/1; mg/1
52389-154_a8a46c50-1eb6-4173-843f-fde86336c9bf 52389-154 HUMAN OTC DRUG
Pep-Back Ultra Caffeine "TABLET, FILM COATED" ORAL 19930408
OTC MONOGRAPH FINAL part340 "Alva-Amco Pharmacal Companies, Inc." CAFFEINE
200 mg/1
52389-155_bb908790-56ce-4543-aa20-e8ae48bfa93e 52389-155 HUMAN OTC DRUG
Diurex Ultra Caffeine "TABLET, FILM COATED" ORAL 20050901
OTC MONOGRAPH NOT FINAL part357 "Alva-Amco Pharmacal Companies, Inc." CAFFEINE
100 mg/1
52389-160_ff220f26-07a9-4828-ac94-17a75362f341 52389-160 HUMAN OTC DRUG
Fungicure Manicure Pedicure Clotrimazole LIQUID TOPICAL 20020715
OTC MONOGRAPH FINAL part333C "Alva-Amco Pharmacal Companies, Inc."
CLOTRIMAZOLE 10 mg/mL
52389-161_919bfa4c-d186-45ce-8995-a45086436221 52389-161 HUMAN OTC DRUG
Fungicure Ultra Original Formula Undecylenic acid LIQUID TOPICAL
19950101 OTC MONOGRAPH FINAL part333C "Alva-Amco Pharm
acal Companies, Inc." UNDECYLENIC ACID 100 mg/mL
52389-162_81611424-a7d6-4a12-af30-f1877caa60c7 52389-162 HUMAN OTC DRUG
Fungicure Tolnaftate GEL TOPICAL 19941001
TOLNAFTATE 10 mg/g
52389-166_8851d133-7460-4c02-b972-7fe6db19c181 52389-166 HUMAN OTC DRUG
Psoriasin Gel Coal Tar Topical Gel GEL TOPICAL 19960218
OTC MONOGRAPH FINAL part358H "Alva-Amco Pharmacal Companies, Inc."
COAL TAR 12.5 mg/g
52389-168_6e6c0678-0385-493d-baa6-b598f7535ab7 52389-168 HUMAN OTC DRUG
Fungicure Professional Formula Undecylenic Acid LIQUID TOPICAL
52389-169_e884fcee-5844-4e53-bb71-92485743cffc 52389-169 HUMAN OTC DRUG
Psoriasin Coal Tar LIQUID TOPICAL 20020120
OTC MONOGRAPH FINAL part358 "Alva-Amco Pharmacal Companies, Inc." COAL TAR
6.6 mg/mL
52389-171_a7138a76-0ec2-453c-9404-af6b8f4f1b5a 52389-171 HUMAN OTC DRUG
Psoriasin Therapeutic Shampoo and Body Wash Salicylic acid SHAMPOO
TOPICAL 19990228 OTC MONOGRAPH FINAL part358 "Alva-Amco Pharm
acal Companies, Inc." SALICYLIC ACID 3 g/100g
52389-172_b35b5e0f-9b2e-40ae-9db7-65f245e40844 52389-172 HUMAN OTC DRUG
Nauzene Sodium Citrate SYRUP ORAL 20000215 OTC MONO
GRAPH NOT FINAL part357 "Alva-Amco Pharmacal Companies, Inc." DEXTROSE; FRUCTO
SE; TRISODIUM CITRATE DIHYDRATE 4.35; 4.17; .921 g/15mL; g/15mL; g/15mL
52389-173_b67eb1da-8294-44ef-8081-63fe44b8503c 52389-173 HUMAN OTC DRUG
Prosacea Sulphur GEL TOPICAL 20060206 UNAPPROV
ED HOMEOPATHIC "Alva-Amco Pharmacal Companies, Inc." SULFUR 1
[hp_X]/g
52389-178_ee1cac18-384e-4568-8672-64c39c777784 52389-178 HUMAN OTC DRUG
Psoriasin Coal Tar OINTMENT TOPICAL 20040601
OTC MONOGRAPH FINAL part358 "Alva-Amco Pharmacal Companies, Inc." COAL TAR
20 mg/g
52389-179_45a475d4-a736-4afe-a06f-a5a8fa02c0ac 52389-179 HUMAN OTC DRUG
Herpetrol "Benzalkonium chloride, menthol, petrolatum" OINTMENT
TOPICAL 20050630 OTC MONOGRAPH FINAL part348 "Alva-Amco Pharm
acal Companies, Inc." BENZALKONIUM CHLORIDE; MENTHOL; PETROLATUM 1.3; 10;
970 mg/g; mg/g; mg/g
52389-198_e1986b31-3c38-48e9-a5f2-ced46228ce90 52389-198 HUMAN OTC DRUG
Fungicure Maximum Strength Undecylenic Acid LIQUID TOPICAL
52389-237_1ddb6099-bcf5-46d8-aae0-c08f688100d7 52389-237 HUMAN OTC DRUG
Arthriten Inflammatory Pain Formula "acetaminophen, aspirin, caffein
T FINAL part343 "Alva-Amco Pharmacal Companies, Inc." ACETAMINOPHEN; ASPIRIN;
CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1
52389-241_b73d5d2c-8fca-482e-b3fe-a1f695ae0d46 52389-241 HUMAN OTC DRUG
Uricalm Maximum Strength Phenazopyridine Hydochloride "TABLET, FILM CO
ATED" ORAL 20080429 UNAPPROVED DRUG OTHER "Alva-Am
co Pharmacal Companies, Inc." PHENAZOPYRIDINE HYDROCHLORIDE 99.5 mg/1
52389-242_9a627c00-3591-4633-b678-31e6ce805b80 52389-242 HUMAN OTC DRUG
Nauzene Sodium Citrate "TABLET, CHEWABLE" ORAL 20000708
UNAPPROVED DRUG OTHER "Alva-Amco Pharmacal Companies, Inc." TRISODIU
M CITRATE DIHYDRATE 230 mg/1
52389-249_6ff153a1-aff6-4ea3-9945-f0d1ec8fea9d 52389-249 HUMAN OTC DRUG
Diurex Max Pamabrom "TABLET, FILM COATED" ORAL 19951220
OTC MONOGRAPH NOT FINAL part357 "Alva-Amco Pharmacal Companies, Inc." PAMABROM
50 mg/1
52389-263_7171e9e6-f2a0-4b32-92b8-400447de241d 52389-263 HUMAN OTC DRUG
Fungicure Pumpspray Clotrimazole LIQUID TOPICAL 20020301
52389-266_f26876dc-c0ab-4a3f-bfa4-d50b361eeb30 52389-266 HUMAN OTC DRUG
Psoriasin Coal Tar GEL TOPICAL 19960218
COAL TAR 12.5 mg/g
52389-306_6ed33c8b-f52c-44b1-86dc-cc59f07c3b41 52389-306 HUMAN OTC DRUG
Diurex Water Pills "Caffeine, magnesium salicylate" "TABLET, COATED"
ORAL 20050515 OTC MONOGRAPH NOT FINAL part343 "Alva-Amco Pharm
acal Companies, Inc." CAFFEINE; MAGNESIUM SALICYLATE 50; 162.5 mg/1; mg
/1
52389-325_af12beff-d5c5-495b-910e-fb88915e89e4 52389-325 HUMAN OTC DRUG
Diurex Pamabrom CAPSULE ORAL 20050401 OTC MONO
GRAPH NOT FINAL part357 "Alva-Amco Pharmacal Companies, Inc." PAMABROM
50 mg/1
52389-600_2c889a34-c50d-4561-b857-2f04ade6472e 52389-600 HUMAN OTC DRUG
Fungicure Intensive Clotrimazole LIQUID TOPICAL 20080605
52389-606_09c1c792-a69b-4165-bb76-ca9f04b18c08 52389-606 HUMAN OTC DRUG
Acnevir Facial Wash Salicylic Acid SOAP TOPICAL 20091201
OTC MONOGRAPH FINAL part333D "Alva-Amco Pharmacal Companies, Inc."
52389-608_fe881432-18bc-438c-993b-d5024af34aa8 52389-608 HUMAN OTC DRUG
AcneVir "Sulphur, resorcinol, salicylic acid" GEL TOPICAL 20091201
UNAPPROVED HOMEOPATHIC "Alva-Amco Pharmacal Companies, Inc." RESORCIN
OL; SALICYLIC ACID; SULFUR 2; 3; 1 [hp_X]/g; [hp_X]/g; [hp_X]/g
52389-610_ab6524fe-005d-4d4b-abd0-10c7f2d062e8 52389-610 HUMAN OTC DRUG
Tranquil Nighttime Diphenhydramine Hydrochloride TABLET ORAL
20100830 OTC MONOGRAPH FINAL part338 "Alva-Amco Pharmacal Com
panies, Inc." DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1
52389-612_a66d47e3-6449-488c-956b-e2247e76b2d4 52389-612 HUMAN OTC DRUG
Nauzene Motion "Bryonia alba root, sepia" "TABLET, COATED" ORAL
20110915 UNAPPROVED HOMEOPATHIC "Alva-Amco Pharmacal Com
panies, Inc." BRYONIA ALBA ROOT; SEPIA OFFICINALIS JUICE 3; 12 [hp_X]/1
; [hp_X]/1
52389-613_992f7ac1-ecda-4bd2-863e-9630c9c77f19 52389-613 HUMAN OTC DRUG
Diurex WaterCaps Caffeine "TABLET, FILM COATED" ORAL 20090415
OTC MONOGRAPH NOT FINAL part357 "Alva-Amco Pharmacal Companies, Inc." CAFFEINE
200 mg/1
52389-621_91e26dd5-5637-44ff-b11f-6e0e1cbb6ca4 52389-621 HUMAN OTC DRUG
Nauzene Homeopathic "Lactic acid, wild hops" LIQUID ORAL
20140408 UNAPPROVED HOMEOPATHIC "Alva-Amco Pharmacal Com
panies, Inc." BRYONIA ALBA ROOT; LACTIC ACID 3; 3 [hp_X]/15mL; [hp_X]/15mL
52389-622_b1dc7b4d-ef8d-4d00-90f1-107eb34e4fc5 52389-622 HUMAN OTC DRUG
BackAid Inflammatory Pain Formula "acetaminophen, aspirin, caffeine"
"TABLET, FILM COATED" ORAL 20121022 OTC MONOGRAPH NOT FINAL
part343 "Alva-Amco Pharmacal Companies, Inc." ACETAMINOPHEN; ASPIRIN; CAFFEINE
250; 250; 65 mg/1; mg/1; mg/1
52389-623_d83a2f05-31bd-4ca9-be49-3953df23d861 52389-623 HUMAN OTC DRUG
Verticalm Meclizine Hydrochloride TABLET ORAL 20120416
OTC MONOGRAPH FINAL part336 "Alva-Amco Pharmacal Companies, Inc." MECLIZIN
E HYDROCHLORIDE 25 mg/1
52389-627_7ee39721-9642-428f-9cd1-30f9a532cc53 52389-627 HUMAN OTC DRUG
Psoriasin Medicated Wash Salicylic acid SOAP TOPICAL 20110102
52389-628_39075e22-6df7-48b1-9aa8-2aef6cde31e8 52389-628 HUMAN OTC DRUG
Eczemin Pramoxine Hydrochloride CREAM TOPICAL 20111116
OTC MONOGRAPH NOT FINAL part348 "Alva-Amco Pharmacal Companies, Inc." PRAMOXIN
E HYDROCHLORIDE 10 mg/g
52389-633_25c7a36c-6f2d-41c4-b357-1e3421974e8b 52389-633 HUMAN OTC DRUG
Fungicure Maximum Strength Undecylenic Acid GEL TOPICAL
acal Companies, Inc." UNDECYLENIC ACID 250 mg/g
52389-638_99955b20-ec50-4524-8746-7a94f7e73ac3 52389-638 HUMAN OTC DRUG
Lysimax "Benzalkonium chloride, menthol, petrolatum" OINTMENT
TOPICAL 20130904 OTC MONOGRAPH NOT FINAL part348 "Alva-Amco Pharm
acal Companies, Inc." BENZALKONIUM CHLORIDE; MENTHOL; PETROLATUM 1.3; 10;
970 mg/g; mg/g; mg/g
52389-642_f474c04d-75fb-47f7-880a-9e68b676d114 52389-642 HUMAN OTC DRUG
Uricalm Intensive "acetaminophen, aspirin, caffeine" "TABLET, FILM CO
ATED" ORAL 20130923 OTC MONOGRAPH NOT FINAL part343 "Alva-Am
co Pharmacal Companies, Inc." ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250
; 65 mg/1; mg/1; mg/1
52389-729_4be5cebb-cc19-4014-8e9e-9f2d71179af1 52389-729 HUMAN OTC DRUG
Nauzene Grape Sodium Citrate SYRUP ORAL 20120424 UNAPPROV
ED DRUG OTHER "Alva-Amco Pharmacal Companies, Inc." TRISODIUM CITRAT
E DIHYDRATE 0.921 g/15mL
47781-216_3ee13bfd-eb5e-a3f1-77bf-46de370644a9 47781-216 HUMAN PRESCRIPTI
ON DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET ORAL
20121112 ANDA ANDA202114 ALVOGEN DONEPEZIL HYDROCHLORIDE
5 mg/1 "Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]"
47781-217_3ee13bfd-eb5e-a3f1-77bf-46de370644a9 47781-217 HUMAN PRESCRIPTI
ON DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET ORAL
20121112 ANDA ANDA202114 ALVOGEN DONEPEZIL HYDROCHLORIDE
10 mg/1 "Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]"
47781-100_b48e595c-7f82-47f3-f1ca-27a0a81cb6f9 47781-100 HUMAN PRESCRIPTI
ON DRUG nevirapine nevirapine TABLET ORAL 20120522
ANDA ANDA203176 Alvogen Inc. NEVIRAPINE 200 mg/1 "Human I
mmunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [E
PC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcrip
tase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Indu
cers [MoA]"
47781-103_080745f7-627a-3e63-cea0-07a43878e93d 47781-103 HUMAN PRESCRIPTI
ON DRUG IBANDRONATE SODIUM IBANDRONATE SODIUM TABLET ORAL
20140501 ANDA ANDA078998 Alvogen Inc. IBANDRONATE SODI
UM 150 mg/1 "Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredien
t]"
47781-108_45f05e2e-ec00-9fb8-78ea-9e91bad9d29d 47781-108 HUMAN PRESCRIPTI
ON DRUG Exemestane Exemestane TABLET ORAL 20140725
ANDA ANDA200898 Alvogen Inc. EXEMESTANE 25 mg/1 "Aromata
se Inhibitor [EPC],Aromatase Inhibitors [MoA]"
47781-135_af200175-22ea-e0cb-d5b7-466c642919c6 47781-135 HUMAN PRESCRIPTI
ON DRUG "Dorzolamide Hydrochloride Ophthalmic Solution 2%, 10mL" "Ophthal
mic Solution 2%, 10mL" "Dorzolamide Hydrochloride Ophthalmic Solution 2%, 10mL"
SOLUTION OPHTHALMIC 20131216 ANDA ANDA091034
ALVOGEN INC. DORZOLAMIDE HYDROCHLORIDE 22.3 mg/mL "Carbonic Anhydr
ase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA]"
47781-136_28d35df3-b0d6-1dad-0bfa-0c257b62c3b2 47781-136 HUMAN PRESCRIPTI
ON DRUG Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution Sterile
Ophthalmic Solution Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Sol
ution SOLUTION OPHTHALMIC 20131217 ANDA ANDA0911
80 ALVOGEN INC. DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE 22.3; 6.
8 mg/mL; mg/mL "Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase I
nhibitors [MoA],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]"
47781-303_8d339ec9-41d7-69ac-cfd4-648474f6c2a1 47781-303 HUMAN PRESCRIPTI
ON DRUG Nitrofurantoin Monohydrate/ Macrocrystalline Nitrofurantoin M
onohydrate/Macrocrystalline CAPSULE ORAL 20110525 NDA
NDA020064 Alvogen Inc. NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE
25; 75 mg/1; mg/1 "Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/In
gredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient]"
47781-306_06f0bea0-961c-7875-2628-a9c70e6d1d8e 47781-306 HUMAN PRESCRIPTI
CAPSULE ORAL 20100927 NDA NDA016620 Alvogen Inc.
NITROFURANTOIN 25 mg/1 "Nitrofuran Antibacterial [EPC],Nitrofurans [Che
mical/Ingredient]"
mical/Ingredient]"
mical/Ingredient]"
47781-607_912bdb9b-01f8-a63f-8e3e-ba17116dd5a8 47781-607 HUMAN PRESCRIPTI
ON DRUG Disulfiram Disulfiram TABLET ORAL 20120831
ANDA ANDA091681 Alvogen Inc. DISULFIRAM 250 mg/1 "Acetyl
Aldehyde Dehydrogenase Inhibitors [MoA],Aldehyde Dehydrogenase Inhibitor [EPC]"
47781-147_1d137c2c-fd59-4203-8115-b0a25a282bef 47781-147 HUMAN PRESCRIPTI
ON DRUG Gadopentetate dimeglumine Gadopentetate dimeglumine
INJECTION INTRAVENOUS 20140224 NDA AUTHORIZED GENERIC
NDA019596 "Alvogen, Inc" GADOPENTETATE DIMEGLUMINE 469.01 mg/mL
47781-147_7a334ed0-990b-4d48-bd67-7273f5451a25 47781-147 HUMAN PRESCRIPTI
ON DRUG Gadopentetate dimeglumine gadopentetate dimeglumine
INJECTION INTRAVENOUS 20140224 NDA AUTHORIZED GENERIC
NDA021037 "Alvogen, Inc" GADOPENTETATE DIMEGLUMINE 469.01 mg/mL
47781-204_9de1f30a-1ac9-4a75-86a2-6e73c5d0901e 47781-204 HUMAN PRESCRIPTI
ON DRUG Estradiol Transdermal System Estradiol PATCH TRANSDER
MAL 20111220 NDA NDA020375 "Alvogen, Inc." ESTRADIO
47781-219_f397afea-5aee-4762-adc3-206825c3dd02 47781-219 HUMAN PRESCRIPTI
ANDA202076 "Alvogen, Inc." ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325; 37.
5 mg/1; mg/1 "Full Opioid Agonists [MoA],Opioid Agonist [EPC]"
47781-229_5f209d65-6730-ab8e-01d5-bda39850905f 47781-229 HUMAN PRESCRIPTI
TABLET ORAL 20120117 ANDA ANDA202677 "Alvogen, Inc."
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 7.5 mg/1; mg/1 "Full Op
ioid Agonists [MoA],Opioid Agonist [EPC]"
47781-230_5f209d65-6730-ab8e-01d5-bda39850905f 47781-230 HUMAN PRESCRIPTI
TABLET ORAL 20120117 ANDA ANDA202677 "Alvogen, Inc."
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 10 mg/1; mg/1 "Full Opioid Ago
nists [MoA],Opioid Agonist [EPC]"
47781-263_be567caa-3326-31c8-820a-01aefa71e8cc 47781-263 HUMAN PRESCRIPTI
ON DRUG Oxycodone hydrochloride Oxycodone hydrochloride TABLET ORAL
20111103 ANDA ANDA202116 "Alvogen, Inc." OXYCODONE HYDROC
HLORIDE 5 mg/1 "Full Opioid Agonists [MoA],Opioid Agonist [EPC]"
CII
CII
CII
47781-266_3232eab3-5f88-4c41-bdab-c1fd71e8dfe9 47781-266 HUMAN PRESCRIPTI
ON DRUG Cefaclor Cefaclor CAPSULE ORAL 20100118
ANDA ANDA065146 "Alvogen, Inc." CEFACLOR 250 mg/1
47781-267_3232eab3-5f88-4c41-bdab-c1fd71e8dfe9 47781-267 HUMAN PRESCRIPTI
ON DRUG Cefaclor Cefaclor CAPSULE ORAL 20100118
ANDA ANDA065146 "Alvogen, Inc." CEFACLOR 500 mg/1
47781-268_7b4e61f6-d473-4f29-ab37-4795ee8ff3c3 47781-268 HUMAN PRESCRIPTI
ON DRUG Moxifloxacin Hydrochloride moxifloxacin hydrochloride
"TABLET, FILM COATED" ORAL 20140129 NDA AUTHORIZED GENERIC
NDA021085 "Alvogen, Inc." MOXIFLOXACIN HYDROCHLORIDE 400 mg/1
47781-275_5eb21926-33e6-45c3-99fa-03454e493be8 47781-275 HUMAN PRESCRIPTI
ON DRUG Isosorbide Mononitrate Extended Release Isosorbide Mononitrate
22 "Alvogen, Inc." ISOSORBIDE MONONITRATE 60 mg/1
47781-296_96b7d6f6-2df7-7ef4-f10e-518aba37f1bf 47781-296 HUMAN PRESCRIPTI
ON DRUG Nitroglycerin Transdermal Delivery System nitroglycerin
PATCH TRANSDERMAL 20101110 ANDA ANDA089771 "Alvogen
, Inc." NITROGLYCERIN 2.5 mg/d "Nitrate Vasodilator [EPC],Nitrates [Che
, Inc." NITROGLYCERIN 5 mg/d "Nitrate Vasodilator [EPC],Nitrates [Che
47781-331_1333abef-2b71-3b54-679c-ec20b5047b65 47781-331 HUMAN PRESCRIPTI
ON DRUG Primaquine Phosphate Primaquine Phosphate "TABLET, FILM CO
ATED" ORAL 20111208 ANDA ANDA203924 "Alvogen, Inc."
PRIMAQUINE PHOSPHATE 26.3 mg/1 Antimalarial [EPC]
47781-340_0d159914-4c29-45bc-94c4-53a037e9a286 47781-340 HUMAN PRESCRIPTI
ON DRUG Acarbose acarbose TABLET ORAL 20080130
NDA AUTHORIZED GENERIC NDA020482 "Alvogen, Inc." ACARBOSE 25
mg/1 "alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC]"
47781-368_e6d04375-aec5-41df-ae7a-8cb87cf32d86 47781-368 HUMAN PRESCRIPTI
ON DRUG Nifedipine nifedipine "TABLET, FILM COATED, EXTENDED R
ELEASE" ORAL 19930421 NDA AUTHORIZED GENERIC NDA020198
"Alvogen, Inc." NIFEDIPINE 30 mg/1 "Calcium Channel Antagonists [Mo
edient]"
edient]"
edient]"
47781-729_6e57ccc2-867e-5f1b-18fc-7c6078ad3d60 47781-729 HUMAN PRESCRIPTI
ON DRUG vancomycin hydrochloride vancomycin hydrochloride
CAPSULE ORAL 20120409 ANDA ANDA065490 "Alvogen, Inc."
47781-730_6e57ccc2-867e-5f1b-18fc-7c6078ad3d60 47781-730 HUMAN PRESCRIPTI
ON DRUG vancomycin hydrochloride vancomycin hydrochloride
CAPSULE ORAL 20120409 ANDA ANDA065490 "Alvogen, Inc."
59338-775_e116bb91-6743-11e3-949a-0800200c9a66 59338-775 HUMAN PRESCRIPTI
ON DRUG Feraheme ferumoxytol INJECTION INTRAVENOUS
20090713 NDA NDA022180 "AMAG Pharmaceuticals, Inc."
FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITE 510 mg/17mL "Parenteral Iron
Replacement [EPC],Iron [Chemical/Ingredient]"
41499-105_9445eaa1-1039-487f-baa3-3e9b28d9f43d 41499-105 HUMAN OTC DRUG
Amar Petroleum All Purpose Adults Petrolatum JELLY TOPICAL 20100501
OTC MONOGRAPH FINAL part347 Amar Remedies Limited PETROLATUM 99.8
g/100g
41499-123_dfe38d4d-50ba-41f2-afbd-772970bc3cff 41499-123 HUMAN OTC DRUG
Amar Ice Menthol GEL TOPICAL 20100501 OTC MONO
GRAPH FINAL part341 AMAR REMEDIES LIMITED MENTHOL 2.5 g/100g
41499-124_db5a0d57-fdd3-4404-934c-fcc80ea2ccda 41499-124 HUMAN OTC DRUG
Amar Petroleum with Aloe Vera Petrolatum JELLY TOPICAL 20110701
g/100g
41499-125_d6f52cbe-b2e0-45ff-b44e-82e401777160 41499-125 HUMAN OTC DRUG
Amar Petroleum Cocoa Butter Scented Petrolatum JELLY TOPICAL 20110701
g/100g
41499-106_2afb264a-4297-4573-8c55-0d20ca4d62bb 41499-106 HUMAN OTC DRUG
Amar Regular Sodium monofluorophosphate "PASTE, DENTIFRICE" DENTAL
20091201 OTC MONOGRAPH FINAL part355 Amar Remedies Limited -
Mumbai SODIUM MONOFLUOROPHOSPHATE 0.76 g/100g
41499-107_356bdab6-1be3-49ca-aacb-98bca738b55a 41499-107 HUMAN OTC DRUG
Amar Advanced Whitening Sodium Fluoride "PASTE, DENTIFRICE" DENTAL
20091201 OTC MONOGRAPH FINAL part355 Amar Remedies Limited -
Mumbai SODIUM FLUORIDE 0.22 g/100g
41499-122_ea0fd21e-543e-452d-a5a5-cb271224eed0 41499-122 HUMAN OTC DRUG
Amar Vaporizing Chest Rub "Camphor (Synthetic), Eucalyptus Oil, an
d Menthol" OINTMENT TOPICAL 20100501 OTC MONOGRAPH FI
NAL part341 Amar Remedies Limited - Mumbai CAMPHOR (SYNTHETIC); EUCALYPTUS
OIL; MENTHOL 5.25; 1.6; 3.15 g/100g; g/100g; g/100g
52937-001_8377aac8-8fdd-4396-9424-aa417c1b39d7 52937-001 HUMAN PRESCRIPTI
ON DRUG Vascepa icosapent ethyl CAPSULE ORAL 20121001
NDA NDA202057 Amarin Pharma Inc. ICOSAPENT ETHYL 1000 mg/1
60899-010_7262e2eb-e7de-452c-81d3-f6f64603465a 60899-010 HUMAN OTC DRUG
Seaweed Aqua Massage Allantoin CREAM TOPICAL 20130901
OTC MONOGRAPH FINAL part347 "AMAROS CO., LTD." ALLANTOIN 1.5
g/300g
60899-020_2bf5bb8b-96b2-4057-bf16-3ed7b8473519 60899-020 HUMAN OTC DRUG
Nano Gold Bio Mask Pack Allantoin PATCH TOPICAL 20130901
mg/35mL
60899-030_4b22428c-d4f4-4948-8cbd-1a33e24ac4d5 60899-030 HUMAN OTC DRUG
Camellia Multiaction UV Sun Serum "Titanium Dioxide, OCTINOXATE"
CREAM TOPICAL 20130901 OTC MONOGRAPH NOT FINAL part352 "AMAROS
CO., LTD." OCTINOXATE; TITANIUM DIOXIDE 1.4; 1.88 mg/40mL; mg/40mL
60899-040_2c4505e8-c145-480c-a1a6-c780261a3a53 60899-040 HUMAN OTC DRUG
OHL O2 Allantoin SPRAY TOPICAL 20130901 OTC MONO
GRAPH FINAL part347 "AMAROS CO., LTD." ALLANTOIN 0.3 mg/60mL
60899-050_c9794724-eccb-43bf-967a-ce7477d13e25 60899-050 HUMAN OTC DRUG
Seaweed Cleansing Mineral Oil LIQUID TOPICAL 20130901
OTC MONOGRAPH FINAL part347 "AMAROS CO., LTD." MINERAL OIL 75
mg/150mL
60899-060_b15871aa-0139-4f2c-a9b8-a836099f988a 60899-060 HUMAN OTC DRUG
Herbal Skin Toner Allantoin CREAM TOPICAL 20130901
mg/150mL
60899-070_63ff976c-af90-4ce7-9375-c17104b807a3 60899-070 HUMAN OTC DRUG
NoblRose Foam Cleanser Allantoin LIQUID TOPICAL 20130901
mg/150mL
60899-080_0cd2cb88-fc95-4881-abc4-d61cfe77bfbc 60899-080 HUMAN OTC DRUG
Acne Lab Foam Cleanser Salicylic acid LIQUID TOPICAL 20130901
OTC MONOGRAPH FINAL part333D "AMAROS CO., LTD." SALICYLIC ACID
0.75 mg/150mL
60899-090_ce6e208a-ccc1-45bb-ba32-c5ea97da4486 60899-090 HUMAN OTC DRUG
Vital Fluid IV Nano Gold Serum Allantoin CREAM TOPICAL 20130901
mg/30mL
60899-100_e950e196-d09e-4ad0-8a1e-9d05f23f7037 60899-100 HUMAN OTC DRUG
Vital Fluid II EGF and FGF Whitening Serum Allantoin CREAM
TOPICAL 20130901 OTC MONOGRAPH FINAL part347 "AMAROS CO., LTD
." ALLANTOIN 0.15 mg/30mL
60899-110_268b1884-aef4-48cd-8c3e-0f8f2f2baafe 60899-110 HUMAN OTC DRUG
Vital Fluid I Platinum Anti Wrinkle Serum Allantoin CREAM
TOPICAL 20130901 OTC MONOGRAPH FINAL part347 "AMAROS CO., LTD
." ALLANTOIN 0.15 mg/30mL
58167-112_635414da-adef-4eac-be68-daf3f35f892e 58167-112 HUMAN OTC DRUG
Mata Balm "Camphor, Menthol" OINTMENT TOPICAL 20130427
OTC MONOGRAPH NOT FINAL part348 Amata LLC CAMPHOR (NATURAL); MENTHOL
45; 367 mg/g; mg/g
24438-001_fab49a9f-9c0f-4a00-81cf-c9bbd5ef0826 24438-001 HUMAN OTC DRUG
Phoenix Balm Pain Relief Rub OINTMENT TOPICAL 20111201
OTC MONOGRAPH FINAL part348 "Amazonian Naturals, Inc." CAMPHOR (NATURAL
); MENTHOL; METHYL SALICYLATE 50; 50; 50 mg/g; mg/g; mg/g
64696-1968_9d56bb06-cc9d-420f-878f-b9fc87028136 64696-1968 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS Ambercare Medical Supply Co. OXYGEN 99
L/100L
61327-0015_4f2fccd8-70ba-4cfe-a31e-617c5f981768 61327-0015 HUMAN OTC DRUG
Instant Hand Sanitizer TENNder CARE ETHYL ALCOHOL GEL TOPICAL
20131210 OTC MONOGRAPH NOT FINAL part333E AMC Promotional
Products ALCOHOL 62 mL/100mL
68634-0029_2a94857e-50e3-48f6-bfbc-25ac68d6ae5b 68634-0029 HUMAN OTC DRUG
age renewal deep wrinkle moisturizer "Homosalate, Octisalate, Oxybenz
one, Avobenzone, Octocrylene" CREAM TOPICAL 20100112 OTC MONO
GRAPH FINAL part352 "AMCOL Health and Beauty Solutions, Inc." AVOBENZO
NE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .02; .1; .05; .015; .02
g/g; g/g; g/g; g/g; g/g
68634-0031_3d6d5909-5da6-4436-a39a-e7a3a2a3986e 68634-0031 HUMAN OTC DRUG
age renewal firming and hydrating moisturizer "Octinoxate, Octisalate,
Oxybenzone, Zinc Oxide" CREAM TOPICAL 20091222 OTC MONO
GRAPH FINAL part352 "AMCOL Health and Beauty Solutions, Inc." OCTINOXA
TE; OCTISALATE; OXYBENZONE; ZINC OXIDE .075; .05; .04; .02 g/g; g/g; g/g; g
/g
68634-0032_e8bc0518-5921-4505-99fc-b8c4f30b58c6 68634-0032 HUMAN OTC DRUG
Glycolic Day Cream SPF 30 "Homosalate, Octisalate, Octocrylene, Ox
ybenzone, Avobenzone" CREAM TOPICAL 20100104 OTC MONOGRAPH FI
NAL part352 "AMCOL Health and Beauty Solutions, Inc." AVOBENZONE; HOMO
SALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .1; .05; .02; .05 mL/mL; m
52054-215_aea10af7-6013-4173-b659-f2607fe466de 52054-215 HUMAN PRESCRIPTI
ON DRUG DEXEDRINE DEXTROAMPHETAMINE SULFATE TABLET ORAL
20140701 ANDA ANDA090652 Amedra Pharmaceuticals LLC
DEXTROAMPHETAMINE SULFATE 5 mg/1 "Central Nervous System Stimulan
t [EPC],Central Nervous System Stimulation [PE]" CII
52054-216_aea10af7-6013-4173-b659-f2607fe466de 52054-216 HUMAN PRESCRIPTI
ON DRUG DEXEDRINE DEXTROAMPHETAMINE SULFATE TABLET ORAL
20140701 ANDA ANDA090652 Amedra Pharmaceuticals LLC
DEXTROAMPHETAMINE SULFATE 10 mg/1 "Central Nervous System Stimulan
t [EPC],Central Nervous System Stimulation [PE]" CII
52054-330_40e56a96-dd17-11e3-8b68-0800200c9a66 52054-330 HUMAN PRESCRIPTI
ON DRUG DARAPRIM pyrimethamine TABLET ORAL 19530123
NDA NDA008578 Amedra Pharmaceuticals LLC PYRIMETHAMINE 25
mg/1 "Dihydrofolate Reductase Inhibitor Antimalarial [EPC],Dihydrofolate Redu
ctase Inhibitors [MoA]"
52054-512_f991261e-e032-4eb5-b91f-69abce20b60c 52054-512 HUMAN PRESCRIPTI
ON DRUG DEXEDRINE SPANSULE dextroamphetamine sulfate "CAPSULE
, EXTENDED RELEASE" ORAL 19760802 NDA NDA017078
Amedra Pharmaceuticals LLC DEXTROAMPHETAMINE SULFATE 5 mg/1
CII
CII
CII
52054-550_d4bf6f20-f0a2-11e2-b778-0800200c9a66 52054-550 HUMAN PRESCRIPTI
ON DRUG ALBENZA albendazole "TABLET, FILM COATED" ORAL 19960611
NDA NDA020666 Amedra Pharmaceuticals LLC ALBENDAZOLE 200
mg/1 Antihelminthic [EPC]
52054-803_7753d039-fe21-44d9-9a6f-7bb8a6c9de3c 52054-803 HUMAN PRESCRIPTI
ON DRUG Adrenaclick Epinephrine INJECTION SUBCUTANEOUS
20091125 NDA NDA020800 Amedra Pharmaceuticals LLC
EPINEPHRINE 0.15 mg/.15mL "Adrenergic alpha-Agonists [MoA],Adrener
gic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [
EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient]"
52054-804_7753d039-fe21-44d9-9a6f-7bb8a6c9de3c 52054-804 HUMAN PRESCRIPTI
ON DRUG Adrenaclick Epinephrine INJECTION SUBCUTANEOUS
20091125 NDA NDA020800 Amedra Pharmaceuticals LLC
EPINEPHRINE 0.3 mg/.3mL "Adrenergic alpha-Agonists [MoA],Adrenergic beta
-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Cat
echolamine [EPC],Catecholamines [Chemical/Ingredient]"
51460-0502_843e8d6b-8bb6-4c81-8089-8a500ebe6bd4 51460-0502 HUMAN OTC DRUG
Amerfresh Sodium Monofluorophosphate POWDER DENTAL 19960101
OTC MONOGRAPH FINAL part355 Amercare Products Inc SODIUM MONOFLUOROPHOSPHA
TE 0.76 g/100g
51460-0504_01111ea5-3692-4b9a-889f-6619fb056913 51460-0504 HUMAN OTC DRUG
Amerfresh Medicated Menthol and Zinc Oxide POWDER TOPICAL 20050101
OTC MONOGRAPH FINAL part347 Amercare Products Inc MENTHOL; ZINC OXIDE
.15; 1 g/100g; g/100g
51460-5000_ce8b2eb8-b3cb-4c19-9308-0a5cb68fa0d2 51460-5000 HUMAN OTC DRUG
Amerfresh Sodium Monofluorophosphate "PASTE, DENTIFRICE"
DENTAL 19960101 OTC MONOGRAPH FINAL part355 Amercare Product
s Inc SODIUM MONOFLUOROPHOSPHATE 0.76 g/100g
51460-5010_27b8a829-d438-439c-b6f5-710cb8e2de7a 51460-5010 HUMAN OTC DRUG
Amerfresh Clear Sodium Fluoride "PASTE, DENTIFRICE" DENTAL 19960101
OTC MONOGRAPH FINAL part355 Amercare Products Inc SODIUM FLUORIDE 0.22
g/100g
51460-4943_c7638a29-e685-4160-a04b-fc797af08702 51460-4943 HUMAN OTC DRUG
AMERFRESH ANTIPERSPIRANT DEODORANT ALUMINUM ZIRCONIUM TETRACHLOROHY
DREX GLY STICK TOPICAL 20100706 OTC MONOGRAPH FINAL
part350 "Amercare Products, Inc" ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY
17.8 g/100g
51460-4967_9c8aa994-6715-471d-9fc7-b88d21eec369 51460-4967 HUMAN OTC DRUG
AMERFRESH ANTIPERSPIRANT DEODORANT ALUMINUM ZIRCONIUM TETRACHLOROHY
part350 "Amercare Products, Inc" ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY
17.8 g/100g
51460-4974_693175b7-e3b0-4ff1-ad0e-3e5368205ace 51460-4974 HUMAN OTC DRUG
AMERFRESH ROLL-ON ANTIPERSPIRANT DEODORANT ALUMINUM CHLOROHYDRATE
LIQUID TOPICAL 20100706 OTC MONOGRAPH FINAL part350 "Amercar
e Products, Inc" ALUMINUM CHLOROHYDRATE 1 mL/100mL
51460-0275_2730d4f5-7ec5-4caf-be4a-b9ca774a35cb 51460-0275 HUMAN OTC DRUG
AMERFRESH ANTIBACTERIAL DEODORANT TRICLOCARBAN SOAP TOPICAL
20100903 OTC MONOGRAPH NOT FINAL part333E "Amercare Produc
ts, Inc." TRICLOCARBAN 1.5 g/100g
51460-1111_f4796a85-7502-4122-92d5-4c8af32d3273 51460-1111 HUMAN OTC DRUG
AmerFresh Sodium Fluoride "GEL, DENTIFRICE" ORAL 20121114
OTC MONOGRAPH FINAL part355 "Amercare Products, Inc." SODIUM FLUORIDE
0.187 g/85g
51460-1112_bcfcec5f-dd34-4846-a15e-a2e639956c1a 51460-1112 HUMAN OTC DRUG
AmerFresh Sodium Monofluorophosphate "PASTE, DENTIFRICE"
ORAL 20121114 OTC MONOGRAPH FINAL part355 "Amercare Produc
ts, Inc." SODIUM MONOFLUOROPHOSPHATE 1 mg/g
51460-1113_c4e05d34-45f9-4883-9238-628b1562a55b 51460-1113 HUMAN OTC DRUG
AmerFresh Sodium Monofluorophosphate "POWDER, DENTIFRICE"
ORAL 20111220 OTC MONOGRAPH FINAL part355 "Amercare Produc
ts, Inc." SODIUM MONOFLUOROPHOSPHATE 0.4332 g/57g
41520-106_02c27520-0f7b-46d1-8638-7d8fb15129d8 41520-106 HUMAN OTC DRUG
CAREONE LIME BASIL TRICLOSAN LIQUID TOPICAL 20140206
OTC MONOGRAPH NOT FINAL part333E AMERCIAN SALES COMPANY TRICLOSAN
4.6 mg/mL
49638-001_7d323d29-531f-49d0-b123-b0a9b026429a 49638-001 HUMAN OTC DRUG
Aspirin Low Dose Aspirin TABLET ORAL 20120515 OTC MONO
GRAPH FINAL part343 America Medic ASPIRIN 81 mg/1
49638-002_91ec78d4-1907-43b7-a6d1-0d286b20a3c5 49638-002 HUMAN OTC DRUG
TYLO Extra Strength Acetaminophen TABLET ORAL 20120515
OTC MONOGRAPH FINAL part343 America Medic ACETAMINOPHEN 500 mg/1
58701-001_b778ec0c-1aff-459d-802d-7ddb607a8ebf 58701-001 HUMAN OTC DRUG
First Class Kit Sodium Monofluorophosphate "PASTE, DENTIFRICE"
DENTAL 20130510 OTC MONOGRAPH FINAL part355 "American Airlin
es, Inc." SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g
58701-002_e2a092a7-f382-4d5a-a8d2-d4e60eec2697 58701-002 HUMAN OTC DRUG
Business Class Kit Sodium Monofluorophosphate "PASTE, DENTIFRI
CE" DENTAL 20130510 OTC MONOGRAPH FINAL part355 "America
n Airlines, Inc." SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g
54157-101_aa24120e-2711-4e51-ae20-c6ae96dadb79 54157-101 HUMAN OTC DRUG
MegaFresh Antibacterial Deodorant Triclocarban SOAP TOPICAL
20130304 OTC MONOGRAPH NOT FINAL part333A "American Amenit
ies, Inc." TRICLOCARBAN 0.3 g/100g
54157-102_a2416d56-d014-4b3a-9d51-ab60e21368d7 54157-102 HUMAN OTC DRUG
MegaFresh SODIUM FLUORIDE "GEL, DENTIFRICE" DENTAL 20131104
OTC MONOGRAPH FINAL part355 "American Amenities, Inc." SODIUM FLUORIDE
0.1 g/100g
54157-103_6df27c76-ab9c-4436-a010-bf0443c527de 54157-103 HUMAN OTC DRUG
MegaFresh Fluoride Tooth SODIUM MONOFLUOROPHOSPHATE "PASTE,
"American Amenities, Inc." SODIUM MONOFLUOROPHOSPHATE 0.1 g/100g
54157-104_1202edcc-88aa-413c-9f77-f05d785434a4 54157-104 HUMAN OTC DRUG
MegaFresh SODIUM FLUORIDE "GEL, DENTIFRICE" DENTAL 20140511
OTC MONOGRAPH FINAL part355 "American Amenities, Inc." SODIUM FLUORIDE
0.15 g/100g
15749-801_da2a32ef-7ed4-4a3f-8e0d-326c91b191c6 15749-801 HUMAN PRESCRIPTI
ANDA ANDA062713 "American Antibiotics, Inc" CEPHALEXIN 250
mg/1
15749-802_da2a32ef-7ed4-4a3f-8e0d-326c91b191c6 15749-802 HUMAN PRESCRIPTI
ANDA ANDA062713 "American Antibiotics, Inc" CEPHALEXIN 500
mg/1
15749-820_60804b94-50f2-44c4-a6bf-871cab5af2f1 15749-820 HUMAN PRESCRIPTI
ANDA ANDA062058 "American Antibiotics,Inc" AMOXICILLIN 250
15749-825_60804b94-50f2-44c4-a6bf-871cab5af2f1 15749-825 HUMAN PRESCRIPTI
ANDA ANDA062058 "American Antibiotics,Inc" AMOXICILLIN 500
68759-003_d0b487ac-4e50-45d1-b5ae-844b65e3c8af 68759-003 HUMAN OTC DRUG
YOUTH FULL TINTED MOISTURIZER SPF 15 "OCTINOXATE, TITANIUM DIOXIDE" LIQUID
TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 AMERICAN BEAUTY
COSMETICS OCTINOXATE; TITANIUM DIOXIDE 7.5; 3 mL/100mL; mL/100mL
65663-019_2561b68e-e638-4a1f-9030-e5db72ebca4e 65663-019 HUMAN OTC DRUG
Bodycology white gardenia anti-bacterial scrubbing hand soap Triclosa
n LIQUID TOPICAL 20090721 OTC MONOGRAPH NOT FINAL part333
American Blending and Filling TRICLOSAN 0.3 mL/100mL
65663-020_e6185362-4152-4722-95c6-0dc6903027de 65663-020 HUMAN OTC DRUG
Bodycology white gardenia anti-bacterial foaming hand soap Triclosa
65663-023_52f8212f-1cda-4b32-ae59-723820957345 65663-023 HUMAN OTC DRUG
Bodycology Peppermint Sugar anti-bacterial scrubbing hand soap Triclosa
65663-024_cdd5dde6-c64c-4ef0-b2b9-00b6420e9ea5 65663-024 HUMAN OTC DRUG
Bodycology Sparkling Cranberry anti-bacterial scrubbing hand soap
Triclosan LIQUID TOPICAL 20100125 OTC MONOGRAPH NOT FINAL
part333 American Blending and Filling TRICLOSAN 0.3 mL/100mL
50536-039_4a3298e8-f2b0-4750-81d3-4728a190f484 50536-039 HUMAN OTC DRUG
SANIFOAM HAND SANITIZER ALCOHOL LOTION TOPICAL 20140312
OTC MONOGRAPH NOT FINAL part333A AMERICAN CHEMICAL AND SANITARY SUPPLY IN
C ALCOHOL 62 mL/100mL
50536-077_5dea9929-9fb0-42ca-a8cc-5c170f78da10 50536-077 HUMAN OTC DRUG
PREVENT HAND SANITIZER ALCOHOL GEL TOPICAL 20140312
50536-078_611ddb70-84a1-441c-bc83-e94e6b98c20c 50536-078 HUMAN OTC DRUG
SANIFOAM HAND SANITIZER ALCOHOL GEL TOPICAL 20140312
50536-101_d4fbb536-f988-4bb0-8840-dea3b67716cc 50536-101 HUMAN OTC DRUG
SUPER SUDS ANTI-BACTERIAL ALCOHOL SOAP TOPICAL 20140312
50536-102_dc2e6d32-fde5-4903-ac19-1c0fa6c56bbe 50536-102 HUMAN OTC DRUG
T-CHEM ANTIMICROBIAL HAND ALCOHOL SOAP TOPICAL 20140312
50536-192_2a26a080-9fa8-4984-b58c-57a8e0a38fd2 50536-192 HUMAN OTC DRUG
T-Chem E2 Rated "CHLOROXYLENOL, TRICLOSAN" SOAP TOPICAL 20140312
C CHLOROXYLENOL; TRICLOSAN .45; .06 g/100mL; 1/100mL
49922-001_f2b8ef51-43a1-4f9a-a810-30ff727fdfa2 49922-001 HUMAN OTC DRUG
Secure Instant Foaming Hand Sanitizer Hand Sanitizer LIQUID TOPICAL
20091005 OTC MONOGRAPH NOT FINAL part333 American Cleaning Soluti
ons BENZALKONIUM CHLORIDE 0.1 mL/100mL
49922-002_6d36a498-239e-4f67-b44f-c21e31de900b 49922-002 HUMAN OTC DRUG
Secure Instant Foaming Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID
TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part333A American
Cleaning Solutions BENZALKONIUM CHLORIDE 0.1 mL/100mL
49496-001_add0c5b7-1162-45bd-a79d-206db4e0ec22 49496-001 HUMAN PRESCRIPTI
NDA NDA205712 American Compressed Gases Inc. OXYGEN 992 mL/L
66010-515_edcab71e-e03a-485e-8e50-839d883102c4 66010-515 HUMAN OTC DRUG
"American Continental Techlabs, LLC INSTANT HAND SANITIZER" ethanol
GEL TOPICAL 20100321 OTC MONOGRAPH NOT FINAL part333 American
Continental Techlabs ETHANOL 600 mL/1000mL
52039-001_c62bdafb-778a-4455-a077-2794f2c11099 52039-001 HUMAN OTC DRUG
NATURES PURITY Scented White Petrolatum OINTMENT TOPICAL 20120718
OTC MONOGRAPH FINAL part347 AMERICAN EAGLE STAR IMPORTS INC. PETROLAT
UM 99.9 g/100g
67567-0306_ccd725b8-1d98-4864-9429-b27d8498e7fe 67567-0306 HUMAN OTC DRUG
HeadOn Ultimate Relief Iris Versicolor Root and Bryonia Alba Root STICK
TOPICAL 20100601 UNAPPROVED HOMEOPATHIC American Health
Distributions Inc. BRYONIA ALBA ROOT; IRIS VERSICOLOR ROOT 12; 12 [hp_X]/1
; [hp_X]/1
62584-046_79d6a5ea-77d3-4547-aa67-1b465141b1f5 62584-046 HUMAN PRESCRIPTI
ON DRUG DIDANOSINE DIDANOSINE "CAPSULE, DELAYED RELEASE"
ORAL 20091208 ANDA ANDA077167 American Health Packagin
g DIDANOSINE 250 mg/1 "Human Immunodeficiency Virus Nucleoside
Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingred
ient],Nucleoside Reverse Transcriptase Inhibitors [MoA]"
62584-048_79d6a5ea-77d3-4547-aa67-1b465141b1f5 62584-048 HUMAN PRESCRIPTI
62584-142_84bbd612-4232-42de-8090-5e01d4bb6c0c 62584-142 HUMAN PRESCRIPTI
20071109 ANDA ANDA077794 American Health Packaging
62584-159_85221ba6-8417-499a-9f74-b2d714a7a560 62584-159 HUMAN PRESCRIPTI
ON DRUG Demeclocycline Hydrochloride Demeclocycline Hydrochloride
TABLET ORAL 20101130 ANDA ANDA065425 American Health
Packaging DEMECLOCYCLINE HYDROCHLORIDE 150 mg/1 "Tetracycline-cl
ass Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient]"
62584-163_85221ba6-8417-499a-9f74-b2d714a7a560 62584-163 HUMAN PRESCRIPTI
Packaging DEMECLOCYCLINE HYDROCHLORIDE 300 mg/1 "Tetracycline-cl
ass Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient]"
62584-259_f15d0d2a-3937-4ccf-b57b-e29a8d5acd64 62584-259 HUMAN PRESCRIPTI
gredient]"
62584-265_7e3e4484-6d9a-4c5d-849d-b2e8ea0cd424 62584-265 HUMAN PRESCRIPTI
ON DRUG Metoprolol Tartrate Metoprolol Tartrate "TABLET, FILM CO
ATED" ORAL 20100609 ANDA ANDA077739 American Health
Packaging METOPROLOL TARTRATE 25 mg/1 "Adrenergic beta-Antagon
62584-330_9ba1cfd8-14c9-4de6-88cb-8a78a1d40a53 62584-330 HUMAN PRESCRIPTI
ON DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride
Packaging CHLORPROMAZINE HYDROCHLORIDE 25 mg/1 "Phenothiazine [
62584-331_9ba1cfd8-14c9-4de6-88cb-8a78a1d40a53 62584-331 HUMAN PRESCRIPTI
gredient]"
62584-339_e35d241b-2d4e-4712-abcb-678842687395 62584-339 HUMAN PRESCRIPTI
gredient]"
62584-467_e3be79e8-0c90-475a-b72e-792a4dfa3efb 62584-467 HUMAN PRESCRIPTI
ANDA ANDA073025 American Health Packaging ATENOLOL 50
62584-559_fc0bec48-8ad2-43b5-a053-a615a859227c 62584-559 HUMAN PRESCRIPTI
ON DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET ORAL
st [EPC]"
62584-612_15e83cd1-79a7-4a96-bc18-7818228a4877 62584-612 HUMAN PRESCRIPTI
ON DRUG Amantadine Hydrochloride Amantadine hydrochloride
CAPSULE ORAL 20101021 ANDA ANDA078720 American Health
Packaging AMANTADINE HYDROCHLORIDE 100 mg/1 "Influenza A M2
62584-639_743d1398-942d-4d2f-9547-79c395238447 62584-639 HUMAN PRESCRIPTI
ON DRUG Carbamazepine (Chewable) Carbmazepine (Chewable) "TABLET,
CHEWABLE" ORAL 20091118 ANDA ANDA075712 American
Health Packaging CARBAMAZEPINE 100 mg/1 "Anti-epileptic Agent [E
PC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood
Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA]"
62584-683_24ae1e96-3061-447f-8497-2a18741744ac 62584-683 HUMAN OTC DRUG
Docusate Sodium Docusate Sodium "CAPSULE, LIQUID FILLED" ORAL
20101108 UNAPPROVED DRUG OTHER American Health Packagin
g DOCUSATE SODIUM 100 mg/1
62584-693_10988250-b267-4f10-b264-5f127cc1ae18 62584-693 HUMAN PRESCRIPTI
g DOXYCYCLINE HYCLATE 100 mg/1
62584-693_1157de5c-3da7-4537-b948-5a32b0a1b92c 62584-693 HUMAN PRESCRIPTI
ORAL 20120301 20141217 ANDA ANDA065095 American Health
Packaging DOXYCYCLINE HYCLATE 100 mg/1
62584-713_29ee62a9-6629-4210-bcca-6c9c6ce8bd42 62584-713 HUMAN PRESCRIPTI
ANDA ANDA018832 American Health Packaging ALLOPURINOL 300
62584-715_e3be79e8-0c90-475a-b72e-792a4dfa3efb 62584-715 HUMAN PRESCRIPTI
ANDA ANDA073026 American Health Packaging ATENOLOL 100
62584-733_8c6d2d47-4749-43ca-bc02-779672e3df37 62584-733 HUMAN PRESCRIPTI
Packaging HYDRALAZINE HYDROCHLORIDE 25 mg/1 "Arteriolar Vaso
dilation [PE],Arteriolar Vasodilator [EPC]"
62584-734_8c6d2d47-4749-43ca-bc02-779672e3df37 62584-734 HUMAN PRESCRIPTI
62584-738_87dd7a02-5336-47f5-ae2c-360a8408aef5 62584-738 HUMAN PRESCRIPTI
ON DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bita
rtrate and Acetaminophen TABLET ORAL 20090710 ANDA
ANDA089883 American Health Packaging ACETAMINOPHEN; HYDROCODONE BITAR
CIII
62584-739_6839eaa1-2d1c-409f-80f9-25328c7e2767 62584-739 HUMAN PRESCRIPTI
Antagonists [MoA]"
62584-741_6839eaa1-2d1c-409f-80f9-25328c7e2767 62584-741 HUMAN PRESCRIPTI
Antagonists [MoA]"
62584-746_503828d6-cee0-40b1-a5eb-f484023c420e 62584-746 HUMAN PRESCRIPTI
ANDA ANDA075682 American Health Packaging IBUPROFEN 400
62584-780_f5f32393-581e-4f29-bff0-99cfd8a36ee9 62584-780 HUMAN PRESCRIPTI
ANDA ANDA084277 American Health Packaging METHOCARBAMOL 500
62584-781_f5f32393-581e-4f29-bff0-99cfd8a36ee9 62584-781 HUMAN PRESCRIPTI
62584-812_80ea902e-40d3-4fad-b91a-d7e09f76ed0d 62584-812 HUMAN PRESCRIPTI
ON DRUG Oxazepam Oxazepam CAPSULE ORAL 20130705
ANDA ANDA072251 American Health Packaging OXAZEPAM 10
62584-827_770b1c29-2e06-4627-b8a1-d3f8078288c3 62584-827 HUMAN PRESCRIPTI
ON DRUG CYCLOSPORINE CYCLOSPORINE CAPSULE ORAL 20091211
ANDA ANDA065040 American Health Packaging CYCLOSPORINE 100
mg/1 "Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [M
oA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]"
62584-886_3dc43b70-5c41-4387-9037-ff813cc2abae 62584-886 HUMAN PRESCRIPTI
ON DRUG TRIHEXYPHENIDYL HYDROCHLORIDE TRIHEXYPHENIDYL HYDROCHLORIDE
Packaging TRIHEXYPHENIDYL HYDROCHLORIDE 2 mg/1
62584-887_3dc43b70-5c41-4387-9037-ff813cc2abae 62584-887 HUMAN PRESCRIPTI
ON DRUG TRIHEXYPHENIDYL HYDROCHLORIDE TRIHEXYPHENIDYL HYDROCHLORIDE
Packaging TRIHEXYPHENIDYL HYDROCHLORIDE 5 mg/1
62584-897_4e0a3410-754c-4344-8b0f-f880c598e889 62584-897 HUMAN PRESCRIPTI
ANDA ANDA040625 American Health Packaging FOLIC ACID 1
mg/1
62584-974_b25d7fd9-f9d6-4cb8-a261-3fed63baa638 62584-974 HUMAN PRESCRIPTI
ED RELEASE" ORAL 20100115 ANDA ANDA074984 American
Health Packaging DILTIAZEM HYDROCHLORIDE 120 mg/1 "Calcium Channel
62584-984_d63d7b8d-69e1-4887-a138-37144eab7b55 62584-984 HUMAN PRESCRIPTI
ANDA ANDA040301 American Health Packaging WARFARIN SODIUM 2
62584-988_29ee62a9-6629-4210-bcca-6c9c6ce8bd42 62584-988 HUMAN PRESCRIPTI
ANDA ANDA018832 American Health Packaging ALLOPURINOL 100
62584-994_d63d7b8d-69e1-4887-a138-37144eab7b55 62584-994 HUMAN PRESCRIPTI
ANDA ANDA040301 American Health Packaging WARFARIN SODIUM 5
68084-002_39d504f9-250a-458e-aa65-7439fa25aaeb 68084-002 HUMAN PRESCRIPTI
ON DRUG Loxapine Loxapine CAPSULE ORAL 20130624
ANDA ANDA090695 American Health Packaging LOXAPINE SUCCINATE
10 mg/1
25 mg/1
50 mg/1
68084-005_ad42c611-c15a-472f-a701-0d722d3819f7 68084-005 HUMAN PRESCRIPTI
RELEASE" ORAL 20130515 ANDA ANDA078281 American
Health Packaging PANTOPRAZOLE SODIUM 20 mg/1 "Proton Pump Inh
68084-006_ad42c611-c15a-472f-a701-0d722d3819f7 68084-006 HUMAN PRESCRIPTI
68084-007_fb7c569a-d41d-429d-8e05-e73c1ae4b380 68084-007 HUMAN PRESCRIPTI
ON DRUG Irbesartan Irbesartan TABLET ORAL 20130612
ANDA ANDA203081 American Health Packaging IRBESARTAN 150
[EPC]"
68084-008_2964a1de-2eb6-4011-9c38-52fb4e738402 68084-008 HUMAN PRESCRIPTI
ANDA ANDA077636 American Health Packaging ZONISAMIDE 100
68084-009_a6fb8945-77ed-46e3-a68f-0fc9dd7eb4b1 68084-009 HUMAN PRESCRIPTI
ANDA ANDA070581 American Health Packaging METOCLOPRAMIDE HYDROCHLO
onist [EPC]"
68084-013_fa7e641b-90c5-4fc1-90d3-29ee922086ce 68084-013 HUMAN PRESCRIPTI
ON DRUG Tizanidine Hydrochloride Tizanidine Hydrochloride
Packaging TIZANIDINE HYDROCHLORIDE 4 mg/1 "Adrenergic alph
a2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]"
68084-014_5a956d5a-9981-42d9-8b8b-992c6d9106a8 68084-014 HUMAN PRESCRIPTI
ON DRUG Furosemide furosemide TABLET ORAL 20060621
20150904 ANDA ANDA076796 American Health Packaging FUROSEMI
DE 20 mg/1 "Increased Diuresis at Loop of Henle [PE],Loop Diuretic
[EPC]"
ANDA ANDA076796 American Health Packaging FUROSEMIDE 40
20150913 ANDA ANDA076796 American Health Packaging FUROSEMI
[EPC]"
68084-018_cae60d4e-ef06-4cd9-bdb2-07f682d2de6e 68084-018 HUMAN PRESCRIPTI
ANDA ANDA074112 American Health Packaging ALPRAZOLAM 0.25
ANDA ANDA074112 American Health Packaging ALPRAZOLAM 1
68084-021_01e46f58-8bda-4ff3-ab21-57d5b540d440 68084-021 HUMAN PRESCRIPTI
ON DRUG Abacavir Abacavir Sulfate "TABLET, FILM COATED"
g ABACAVIR SULFATE 300 mg/1 "Human Immunodeficiency Virus Nu
cleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemica
l/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA]"
68084-022_ea5edb3f-f718-4e48-aac6-57aefef60bbc 68084-022 HUMAN PRESCRIPTI
g NIFEDIPINE 10 mg/1 "Calcium Channel Antagonists [MoA],Dihyd
68084-027_f124cc2b-2b1a-40f8-b203-515069d4c08e 68084-027 HUMAN PRESCRIPTI
ANDA ANDA040301 American Health Packaging WARFARIN SODIUM 2.5
68084-028_cb914667-0b1b-4584-a40c-7d34198bf459 68084-028 HUMAN PRESCRIPTI
ON DRUG Buspirone HCl Buspirone hydrochloride TABLET ORAL 20130528
ANDA ANDA074253 American Health Packaging BUSPIRONE HYDROCHLORIDE
5 mg/1
10 mg/1
15 mg/1
68084-031_64c74ccf-23c4-42c3-b55a-3c5d18056ea8 68084-031 HUMAN PRESCRIPTI
Packaging NORTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antide
pressant [EPC]
68084-032_64c74ccf-23c4-42c3-b55a-3c5d18056ea8 68084-032 HUMAN PRESCRIPTI
Packaging NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antide
pressant [EPC]
68084-038_e06518e7-4503-40da-829c-6000dc757367 68084-038 HUMAN PRESCRIPTI
ANDA ANDA072824 American Health Packaging BACLOFEN 10
ic Agonist [EPC]"
68084-039_e06518e7-4503-40da-829c-6000dc757367 68084-039 HUMAN PRESCRIPTI
ic Agonist [EPC]"
68084-040_f902a2a6-0420-4632-a19b-050e40db6803 68084-040 HUMAN PRESCRIPTI
ANDA ANDA091667 American Health Packaging MISOPROSTOL 100
redient]"
68084-041_f902a2a6-0420-4632-a19b-050e40db6803 68084-041 HUMAN PRESCRIPTI
ANDA ANDA091667 American Health Packaging MISOPROSTOL 200
redient]"
68084-044_4a9fd4a5-1fa5-4d6e-a1c1-0cc9e05fda84 68084-044 HUMAN PRESCRIPTI
ON DRUG Paroxetine Paroxetine Hydrochloride "TABLET, FILM CO
Packaging PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 "Seroton
in Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]"
68084-048_0a1d47b5-0215-4636-acac-191e51df8754 68084-048 HUMAN PRESCRIPTI
OXYCODONE HYDROCHLORIDE 10 mg/1 "Full Opioid Agonists [MoA],Opioid Agoni
st [EPC]" CII
68084-050_86aec0c3-0032-415c-928f-ba2232b12e8f 68084-050 HUMAN OTC DRUG
Senna Plus Senna Plus TABLET ORAL 20100114
UNAPPROVED DRUG OTHER American Health Packaging DOCUSATE SODIUM;
SENNOSIDES 50; 8.6 ug/1; mg/1
68084-051_66b54afb-dd2e-4a9a-b523-10330e0ed163 68084-051 HUMAN PRESCRIPTI
ON DRUG Nabumetone Nabumentone TABLET ORAL 20131028
ANDA ANDA075280 American Health Packaging NABUMETONE 500
68084-052_7dc13ebc-914c-4237-9298-b708239b380c 68084-052 HUMAN PRESCRIPTI
ON DRUG Diltiazem Hydrochloride Extended Release Diltiazem Hydrochloride
"CAPSULE, COATED, EXTENDED RELEASE" ORAL 20121212 ANDA
ANDA074984 American Health Packaging DILTIAZEM HYDROCHLORIDE 120
mg/1 "Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]"
68084-052_f7a87108-c0f7-424d-8616-1b42afef9a53 68084-052 HUMAN PRESCRIPTI
68084-056_9e12e018-ea14-4da2-a6f5-d9934c0511c3 68084-056 HUMAN PRESCRIPTI
68084-057_9e12e018-ea14-4da2-a6f5-d9934c0511c3 68084-057 HUMAN PRESCRIPTI
68084-059_a60f39f6-d590-4b00-8751-7f12b7ec5385 68084-059 HUMAN PRESCRIPTI
ON DRUG Zafirlukast Zafirlukast "TABLET, FILM COATED" ORAL
ZAFIRLUKAST 20 mg/1 "Leukotriene Receptor Antagonist [EPC],Leukotrie
ne Receptor Antagonists [MoA],Cytochrome P450 2C9 Inhibitors [MoA]"
68084-060_2c4c085b-45b4-4b11-9a1c-820bb8a97a64 68084-060 HUMAN PRESCRIPTI
ANDA ANDA078402 American Health Packaging LISINOPRIL 5
20151205 ANDA ANDA078402 American Health Packaging LISINOPR
IL 40 mg/1 "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotens
in-converting Enzyme Inhibitors [MoA]"
68084-065_89242d27-8db8-4975-90f3-0e00d0d3d32f 68084-065 HUMAN PRESCRIPTI
ON DRUG Nephrocaps "Ascorbic Acid, Folic Acid, Niacin, Thiamine, Ri
boflavin, Pyridoxine, Cyanocobalamin, Pantothenic Acid, Biotin" "CAPSULE, LIQUID
FILLED" ORAL 20100114 UNAPPROVED DRUG OTHER
American Health Packaging ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; FOLIC ACI
D; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; RIBOFLAVIN; THIAMINE 100; 150; 6; 1;
20; 5; 10; 1.7; 1.5 mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1
"Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B 12 [Chemic
al/Ingredient],Vitamin B12 [EPC]"
68084-066_09853e2b-6b8c-4a03-b458-5fd988b36d7b 68084-066 HUMAN PRESCRIPTI
ON DRUG Citalopram Citalopram TABLET ORAL 20130725
ANDA ANDA077031 American Health Packaging CITALOPRAM HYDROBROMIDE
[MoA]"
68084-069_dd0442f8-0e41-4251-9b4b-53d5a33b24fe 68084-069 HUMAN PRESCRIPTI
ON DRUG Ciprofloxacin ciprofloxacin hydrochloride "TABLET, FILM CO
Packaging CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 "Quinolone Antim
icrobial [EPC],Quinolones [Chemical/Ingredient]"
68084-072_a57dab54-fe14-420b-88ca-d4270e7689f2 68084-072 HUMAN PRESCRIPTI
D RELEASE" ORAL 20101021 ANDA ANDA078596 American
Health Packaging METFORMIN HYDROCHLORIDE 500 mg/1 "Biguanide [EPC]
68084-074_4d68cce9-d9f1-4260-9e68-a106b4fdd4b3 68084-074 HUMAN PRESCRIPTI
ON DRUG Danazol Danazol CAPSULE ORAL 20080827 ANDA
ANDA077246 American Health Packaging DANAZOL 200 mg/1 "Androge
68084-075_b22d5a07-623a-4645-b87d-a151b86da8d5 68084-075 HUMAN PRESCRIPTI
ON DRUG Tretinoin Tretinoin CAPSULE ORAL 20130718
ANDA ANDA201687 American Health Packaging TRETINOIN 10
mg/1 "Retinoid [EPC],Retinoids [Chemical/Ingredient]"
68084-077_9b15533c-61e8-4d76-8323-012c2e922bbe 68084-077 HUMAN PRESCRIPTI
ON DRUG Nitrofurantoin Macrocrystals Nitrofurantoin Macrocrystals
CAPSULE ORAL 20140217 NDA NDA016620 American Health
Packaging NITROFURANTOIN 50 mg/1 "Nitrofuran Antibacterial [EPC],
68084-078_9b15533c-61e8-4d76-8323-012c2e922bbe 68084-078 HUMAN PRESCRIPTI
ON DRUG Nitrofurantoin Macrocrystals Nitrofurantoin Macrocrystals
CAPSULE ORAL 20140217 NDA NDA016620 American Health
Packaging NITROFURANTOIN 100 mg/1 "Nitrofuran Antibacterial [EPC],
68084-082_5c94ecc0-fcaa-4af3-82c2-ff124f2df3e1 68084-082 HUMAN PRESCRIPTI
ON DRUG Isosorbide Dinitrate isosorbide dinitrate TABLET ORAL
ISOSORBIDE DINITRATE 10 mg/1 "Nitrate Vasodilator [EPC],Nitrates [Che
68084-083_5c94ecc0-fcaa-4af3-82c2-ff124f2df3e1 68084-083 HUMAN PRESCRIPTI
ON DRUG Isosorbide Dinitrate isosorbide dinitrate TABLET ORAL
68084-084_c1829c84-80f5-4513-af2e-fc7a0476a0ba 68084-084 HUMAN PRESCRIPTI
ON DRUG Desmopressin Acetate Desmopressin Acetate TABLET ORAL
DESMOPRESSIN ACETATE 0.1 mg/1 "Factor VIII Activator [EPC],Increased C
oagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentra
tion [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient]"
68084-085_c1829c84-80f5-4513-af2e-fc7a0476a0ba 68084-085 HUMAN PRESCRIPTI
68084-086_8d26afa4-4523-4b8d-81ea-9a38351562c4 68084-086 HUMAN PRESCRIPTI
68084-088_09eb2286-4886-4f12-8a3a-a293c65c28c7 68084-088 HUMAN PRESCRIPTI
ANDA ANDA071403 American Health Packaging LORAZEPAM 0.5
ANDA ANDA071404 American Health Packaging LORAZEPAM 1
68084-091_53a6d422-f831-4d09-bf2a-590878eedfae 68084-091 HUMAN PRESCRIPTI
ON DRUG Metoclopramide Metoclopramide hydrochloride TABLET ORAL
METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 "Dopamine D2 Antagonists [MoA],D
opamine-2 Receptor Antagonist [EPC]"
68084-093_dbeede8d-f137-43e7-889d-9661b69e63c2 68084-093 HUMAN PRESCRIPTI
CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 "Aromatic Amino Acid Decarboxyla
tion Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA]"
68084-094_dbeede8d-f137-43e7-889d-9661b69e63c2 68084-094 HUMAN PRESCRIPTI
CARBIDOPA; LEVODOPA 25; 250 mg/1; mg/1 "Aromatic Amino Acid Decarboxyla
tion Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA]"
68084-097_cbb36391-3522-4ef2-a5bb-8e93a765adb8 68084-097 HUMAN PRESCRIPTI
Packaging ATORVASTATIN CALCIUM 10 mg/1 "HMG-CoA Reductase Inhib
itor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"
68084-100_6b7b099b-f3f4-4e64-b92f-0507481cad45 68084-100 HUMAN PRESCRIPTI
CIII
68084-101_ec81c914-34b5-4fef-88be-4bc6b1185d05 68084-101 HUMAN PRESCRIPTI
68084-107_9d16ea0c-5b51-43b8-bf1a-bee84a6a764b 68084-107 HUMAN PRESCRIPTI
ON DRUG ACYCLOVIR ACYCLOVIR CAPSULE ORAL 20140129
ANDA ANDA075677 American Health Packaging ACYCLOVIR 200
68084-108_70038a69-badc-4073-a13e-ebc9bb8146bc 68084-108 HUMAN PRESCRIPTI
ON DRUG acyclovir acyclovir TABLET ORAL 20140129
68084-109_70038a69-badc-4073-a13e-ebc9bb8146bc 68084-109 HUMAN PRESCRIPTI
68084-110_c91b3369-9646-4be6-9a7e-42abf7dc715d 68084-110 HUMAN PRESCRIPTI
ON DRUG bethanechol chloride bethanechol chloride TABLET ORAL
BETHANECHOL CHLORIDE 25 mg/1 "Cholinergic Muscarinic Agonist [EPC],Ch
olinergic Muscarinic Agonists [MoA]"
68084-111_f006b29a-4549-4787-8936-34c878f42649 68084-111 HUMAN PRESCRIPTI
ON DRUG Glipizide ER Glipizide "TABLET, FILM COATED, EXTENDED R
ELEASE" ORAL 20080609 ANDA ANDA076467 American Health
Packaging GLIPIZIDE 5 mg/1 "Sulfonylurea [EPC],Sulfonylurea
Packaging GLIPIZIDE 10 mg/1 "Sulfonylurea [EPC],Sulfonylurea
68084-119_dfeb6d93-c280-430d-b45c-84ebebbb84f3 68084-119 HUMAN PRESCRIPTI
MIRTAZAPINE 15 mg/1
MIRTAZAPINE 30 mg/1
MIRTAZAPINE 45 mg/1
68084-122_e3641eac-d900-4b27-9436-fde708da427d 68084-122 HUMAN PRESCRIPTI
ON DRUG Gabapentin Gabapentin TABLET ORAL 20070802
ANDA ANDA077662 American Health Packaging GABAPENTIN 600
68084-123_e3641eac-d900-4b27-9436-fde708da427d 68084-123 HUMAN PRESCRIPTI
ON DRUG Gabapentin Gabapentin TABLET ORAL 20070813
68084-124_6bcbc9f1-43a5-4110-9d12-b0fcfa62f0dc 68084-124 HUMAN PRESCRIPTI
ON DRUG Trazodone Hydrochloride Trazodone Hydrochloride "TABLET, FILM CO
Packaging TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhib
itor [EPC]
68084-125_6bcbc9f1-43a5-4110-9d12-b0fcfa62f0dc 68084-125 HUMAN PRESCRIPTI
Packaging TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhib
itor [EPC]
68084-126_d92a09ae-017e-487c-bbd7-b284dce406ee 68084-126 HUMAN PRESCRIPTI
ON DRUG Nephrocaps "Ascorbic Acid, Folic Acid, Niacin, Thiamine, Ri
boflavin, Pyridoxine, Cyanocobalamin, Pantothenic Acid, Biotin" "CAPSULE, LIQUID
FILLED" ORAL 20130828 UNAPPROVED DRUG OTHER
American Health Packaging ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; FOLIC ACI
D; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; RIBOFLAVIN; THIAMINE 100; 150; 6; 1;
20; 5; 10; 1.7; 1.5 mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1
"Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B 12 [Chemic
al/Ingredient],Vitamin B12 [EPC]"
68084-127_d6f4dd14-f67a-4fe3-b356-02096c3e338a 68084-127 HUMAN PRESCRIPTI
ANDA ANDA091305 American Health Packaging NAPROXEN 500
68084-128_5e9364c6-6fe1-4c7f-af32-6592c58c1a6c 68084-128 HUMAN PRESCRIPTI
g OMEPRAZOLE 20 mg/1 "Proton Pump Inhibitor [EPC],Proton Pump
68084-129_2a849f8b-84fd-4564-9665-9a32c08fdb01 68084-129 HUMAN PRESCRIPTI
ON DRUG Labetalol hydrochloride Labetalol hydrochloride "TABLET, FILM CO
Packaging LABETALOL HYDROCHLORIDE 100 mg/1 "Adrenergic beta-Antagon
68084-135_6aeb78ea-1d73-4d27-bedc-9a19f3bcccb2 68084-135 HUMAN PRESCRIPTI
ANDA ANDA203399 American Health Packaging METAXALONE 800
68084-144_8b3c4a97-a801-4009-96eb-1b19dbe1d3d5 68084-144 HUMAN PRESCRIPTI
oA]" CIII
oA]" CIII
68084-149_a6406459-a1cc-41f6-b7cb-87daf86bdc8e 68084-149 HUMAN PRESCRIPTI
ON DRUG MethylPREDNISolone methylprednisolone TABLET ORAL
68084-150_24c3b88a-8839-40e5-83c0-07224e42c8f2 68084-150 HUMAN PRESCRIPTI
ON DRUG Ribavirin Ribavirin "TABLET, FILM COATED" ORAL
RIBAVIRIN 200 mg/1 "Nucleoside Analog [Chemical/Ingredient],Nucleos
ide Analog Antiviral [EPC]"
68084-154_f6c624f4-89cf-46bb-a36c-963d671e0f2e 68084-154 HUMAN PRESCRIPTI
Packaging PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 "Phenothiazine [
68084-155_f6c624f4-89cf-46bb-a36c-963d671e0f2e 68084-155 HUMAN PRESCRIPTI
Packaging PROMETHAZINE HYDROCHLORIDE 25 mg/1 "Phenothiazine [
68084-157_a35f34bc-186a-4270-a78c-0430d8605477 68084-157 HUMAN PRESCRIPTI
ON DRUG Morphine Sulfate Extended Release Morphine Sulfate
"TABLET, FILM COATED, EXTENDED RELEASE" ORAL 20130621 ANDA
ANDA074862 American Health Packaging MORPHINE SULFATE 15
mg/1 "Full Opioid Agonists [MoA],Opioid Agonist [EPC]" CII
68084-166_c91b3369-9646-4be6-9a7e-42abf7dc715d 68084-166 HUMAN PRESCRIPTI
ON DRUG bethanechol chloride bethanechol chloride TABLET ORAL
BETHANECHOL CHLORIDE 10 mg/1 "Cholinergic Muscarinic Agonist [EPC],Ch
olinergic Muscarinic Agonists [MoA]"
68084-172_0eef69c8-a0b6-47e2-b2ed-2c67e9fb7676 68084-172 HUMAN PRESCRIPTI
ON DRUG FAMOTIDINE FAMOTIDINE TABLET ORAL 20130705
ANDA ANDA090837 American Health Packaging FAMOTIDINE 20
[EPC]"
68084-174_f47df011-74a3-4fbd-a1c2-9caa002a90e4 68084-174 HUMAN PRESCRIPTI
ANDA ANDA078292 American Health Packaging DRONABINOL 2.5
mg/1 "Cannabinoid [EPC],Cannabinoids [Chemical/Ingredient]" CIII
68084-175_f47df011-74a3-4fbd-a1c2-9caa002a90e4 68084-175 HUMAN PRESCRIPTI
ANDA ANDA078292 American Health Packaging DRONABINOL 5
mg/1 "Cannabinoid [EPC],Cannabinoids [Chemical/Ingredient]" CIII
68084-177_13205ebb-2a2d-4e4d-99e9-3d3d66b71a33 68084-177 HUMAN PRESCRIPTI
MYCOPHENOLATE MOFETIL 250 mg/1 Antimetabolite Immunosuppressant [EPC]
68084-178_13205ebb-2a2d-4e4d-99e9-3d3d66b71a33 68084-178 HUMAN PRESCRIPTI
ON DRUG Mycophenolate Mofetil Mycophenolate Mofetil TABLET ORAL
68084-179_3999b25c-097c-4b15-a6b4-40e730cfef81 68084-179 HUMAN PRESCRIPTI
ON DRUG Ribavirin Ribavirin CAPSULE ORAL 20061130
ANDA ANDA077224 American Health Packaging RIBAVIRIN 200
mg/1 "Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EP
C]"
68084-180_ea049814-c0fa-49f0-a8b3-de168700c886 68084-180 HUMAN PRESCRIPTI
Packaging SERTRALINE HYDROCHLORIDE 25 mg/1 "Serotonin Reupt
68084-183_43a091e8-00b7-478e-843c-354a846fc3ab 68084-183 HUMAN PRESCRIPTI
68084-184_8c3e312d-c7e7-49f2-9e6c-776f3a387d86 68084-184 HUMAN PRESCRIPTI
st [EPC]"
68084-185_8c3e312d-c7e7-49f2-9e6c-776f3a387d86 68084-185 HUMAN PRESCRIPTI
st [EPC]"
68084-189_752c0ee4-5bb8-4316-9e9d-e6e6802797ba 68084-189 HUMAN PRESCRIPTI
ON DRUG Zolpidem Tartrate Zolpidem Tartrate "TABLET, COATED"
g ZOLPIDEM TARTRATE 5 mg/1 "gamma-Aminobutyric Acid-ergic A
gonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervo
us System Depression [PE]" CIV
68084-190_43a091e8-00b7-478e-843c-354a846fc3ab 68084-190 HUMAN PRESCRIPTI
68084-195_b9ff238b-1e7c-4663-aa70-81425d0ced9e 68084-195 HUMAN PRESCRIPTI
ON DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride
American Health Packaging ROPINIROLE HYDROCHLORIDE 0.25 mg/1
68084-196_c9490e6e-c186-4a1b-9c92-dca5023e74f1 68084-196 HUMAN PRESCRIPTI
68084-200_752c0ee4-5bb8-4316-9e9d-e6e6802797ba 68084-200 HUMAN PRESCRIPTI
ON DRUG Zolpidem Tartrate Zolpidem Tartrate "TABLET, COATED"
g ZOLPIDEM TARTRATE 10 mg/1 "gamma-Aminobutyric Acid-ergic A
gonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervo
us System Depression [PE]" CIV
68084-202_afb6f0dd-dd1a-4e1c-bd23-06159add7641 68084-202 HUMAN PRESCRIPTI
ON DRUG Primidone Primidone TABLET ORAL 20070614
ANDA ANDA084903 American Health Packaging PRIMIDONE 50
68084-203_afb6f0dd-dd1a-4e1c-bd23-06159add7641 68084-203 HUMAN PRESCRIPTI
ANDA ANDA084903 American Health Packaging PRIMIDONE 250
68084-204_60f7b19f-6a84-4eb9-b02d-8d067579c4d4 68084-204 HUMAN PRESCRIPTI
ON DRUG Minoxidil Minoxidil TABLET ORAL 20070730
ANDA ANDA071826 American Health Packaging MINOXIDIL 2.5
mg/1 "Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]"
68084-205_60f7b19f-6a84-4eb9-b02d-8d067579c4d4 68084-205 HUMAN PRESCRIPTI
ANDA ANDA071839 American Health Packaging MINOXIDIL 10
68084-206_ce56049c-388f-4953-bab3-6a137c50f04f 68084-206 HUMAN PRESCRIPTI
nists [MoA]"
nists [MoA]"
nists [MoA]"
68084-213_8557f6f0-c798-478b-ae8c-9f7b34d84af5 68084-213 HUMAN PRESCRIPTI
ON DRUG Ursodiol Ursodiol CAPSULE ORAL 20091105
NDA NDA019594 American Health Packaging URSODIOL 300
mg/1 "Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient]"
68084-214_9a71725a-64b6-4800-a79c-aa4b2d74d44f 68084-214 HUMAN PRESCRIPTI
ON DRUG Benzonatate Benzonatate CAPSULE ORAL 20111003
ANDA ANDA040597 American Health Packaging BENZONATATE 100
Antitussive [EPC]"
68084-215_23fb4162-2310-486c-ba9f-f7c94b793e56 68084-215 HUMAN PRESCRIPTI
ON DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride
American Health Packaging VALACYCLOVIR HYDROCHLORIDE 500 mg/1
68084-220_3d24ed55-336b-4143-bb37-817e147591bb 68084-220 HUMAN PRESCRIPTI
American Health Packaging ONDANSETRON HYDROCHLORIDE 4 mg/1
68084-221_3d24ed55-336b-4143-bb37-817e147591bb 68084-221 HUMAN PRESCRIPTI
American Health Packaging ONDANSETRON HYDROCHLORIDE 8 mg/1
68084-225_2a5c9a51-29de-4f83-b02e-98774d8a69e4 68084-225 HUMAN PRESCRIPTI
ON DRUG ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE TABLET ORAL
68084-226_2a5c9a51-29de-4f83-b02e-98774d8a69e4 68084-226 HUMAN PRESCRIPTI
68084-227_aae58c49-2564-461c-8bad-3764dec1833f 68084-227 HUMAN PRESCRIPTI
ON DRUG Hydrocodone Bitartrate and Ibuprofen Hydrocodone Bitartrate a
nd Ibuprofen TABLET ORAL 20091215 ANDA ANDA076642
American Health Packaging HYDROCODONE BITARTRATE; IBUPROFEN 7.5; 200
mg/1; mg/1 "Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhib
itors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonst
eroidal Anti-inflammatory Drug [EPC]" CIII
68084-229_4e27c381-4ec8-4965-8e1c-8bcaa4e62a44 68084-229 HUMAN PRESCRIPTI
ANDA ANDA077621 American Health Packaging AZATHIOPRINE 50
mg/1 "Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Analog [Chemical/Ing
redient],Purine Antimetabolite [EPC],Purines [Chemical/Ingredient]"
68084-230_65057096-1df9-4cb8-829e-8c8bec006d60 68084-230 HUMAN PRESCRIPTI
American Health Packaging SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160
68084-235_de69eafe-b9d3-4dd3-915d-ff2edafc14f4 68084-235 HUMAN PRESCRIPTI
ON DRUG Amoxicillin and Calvulanate Potassium Amoxicillin and Clavulan
ate Potassium TABLET ORAL 20091211 ANDA ANDA065109
American Health Packaging AMOXICILLIN; CLAVULANIC ACID 500; 125
mg/1; mg/1 "beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]"
68084-236_de69eafe-b9d3-4dd3-915d-ff2edafc14f4 68084-236 HUMAN PRESCRIPTI
ON DRUG Amoxicillin and Calvulanate Potassium Amoxicillin and Clavulan
American Health Packaging AMOXICILLIN; CLAVULANIC ACID 875; 125
mg/1; mg/1 "beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]"
68084-240_9bcaa0b3-86df-4698-be10-896aca698142 68084-240 HUMAN PRESCRIPTI
ON DRUG Midodrine HCl Midodrine Hydrochloride TABLET ORAL 20100511
ANDA ANDA076514 American Health Packaging MIDODRINE HYDROCHLORIDE
2.5 mg/1 "Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC]"
68084-241_9bcaa0b3-86df-4698-be10-896aca698142 68084-241 HUMAN PRESCRIPTI
ON DRUG Midodrine HCl Midodrine Hydrochloride TABLET ORAL 20100511
ANDA ANDA076514 American Health Packaging MIDODRINE HYDROCHLORIDE
5 mg/1 "Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC]"
68084-243_7e6c8170-d9f1-4f95-8fd3-ac64e5679dbb 68084-243 HUMAN PRESCRIPTI
Packaging CLINDAMYCIN HYDROCHLORIDE 150 mg/1 "Decreased Sebac
Ingredient]"
68084-244_7e6c8170-d9f1-4f95-8fd3-ac64e5679dbb 68084-244 HUMAN PRESCRIPTI
Packaging CLINDAMYCIN HYDROCHLORIDE 300 mg/1 "Decreased Sebac
Ingredient]"
68084-248_3ac9b0b2-50a3-48b3-8048-e8e9312e0b4c 68084-248 HUMAN OTC DRUG
Loratadine Loratadine TABLET ORAL 20130614
UNAPPROVED DRUG OTHER American Health Packaging LORATADINE
10 mg/1
68084-249_828a617a-79ac-41e3-9ad2-ce5251d5d418 68084-249 HUMAN PRESCRIPTI
ON DRUG Haloperidol Haloperidol TABLET ORAL 20080304
ANDA ANDA077580 American Health Packaging HALOPERIDOL 10
mg/1 Typical Antipsychotic [EPC]
68084-250_828a617a-79ac-41e3-9ad2-ce5251d5d418 68084-250 HUMAN PRESCRIPTI
ON DRUG Haloperidol Haloperidol TABLET ORAL 20080402
ANDA ANDA077580 American Health Packaging HALOPERIDOL 20
mg/1 Typical Antipsychotic [EPC]
68084-251_164cf86e-f389-45de-90c9-93278844eebd 68084-251 HUMAN PRESCRIPTI
Health Packaging BUPROPION HYDROCHLORIDE 150 mg/1 "Aminoketone [EP
68084-252_46199d76-9470-4c63-ab27-ee6e00bc5b48 68084-252 HUMAN PRESCRIPTI
American Health Packaging BUPROPION HYDROCHLORIDE 300 mg/1 "Aminoke
68084-253_6d0ed378-4805-4343-a40f-4f6e89163174 68084-253 HUMAN PRESCRIPTI
ON DRUG HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE
American Health Packaging HYDROXYZINE HYDROCHLORIDE 10 mg/1
68084-256_eb828a02-51f2-4f60-b7cd-c29a6a1aaf39 68084-256 HUMAN PRESCRIPTI
ON DRUG Terbutaline Sulfate Terbutaline Sulfate TABLET ORAL
TERBUTALINE SULFATE 2.5 mg/1
68084-257_eb828a02-51f2-4f60-b7cd-c29a6a1aaf39 68084-257 HUMAN PRESCRIPTI
ON DRUG Terbutaline Sulfate Terbutaline Sulfate TABLET ORAL
TERBUTALINE SULFATE 5 mg/1
68084-258_7b37c4c5-d2d3-44fe-9024-dc2c04f78555 68084-258 HUMAN PRESCRIPTI
68084-261_f97c5b65-4458-47bc-b85f-27bb369f1013 68084-261 HUMAN PRESCRIPTI
68084-266_c2af142a-e0d4-4d3b-af58-cf69f462d835 68084-266 HUMAN PRESCRIPTI
ON DRUG Ramipril ramipril CAPSULE ORAL 20080122
ANDA ANDA076549 American Health Packaging RAMIPRIL 2.5
ANDA ANDA076549 American Health Packaging RAMIPRIL 5
ANDA ANDA076549 American Health Packaging RAMIPRIL 10
68084-269_ca1f9b0f-fcb3-43dc-81d7-15ff544f2b1d 68084-269 HUMAN PRESCRIPTI
ON DRUG Hydroxychloroquine sulfate Hydroxychloroquine sulfate
American Health Packaging HYDROXYCHLOROQUINE SULFATE 200 mg/1
68084-270_27f89aba-8767-46c9-acbf-45cecbbee88d 68084-270 HUMAN PRESCRIPTI
ON DRUG risperidone risperidone "TABLET, FILM COATED" ORAL
RISPERIDONE 0.25 mg/1 Atypical Antipsychotic [EPC]
RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC]
68084-275_03cd3cc8-0214-4624-8571-b45e9e3522ab 68084-275 HUMAN PRESCRIPTI
ON DRUG Methimazole Methimazole TABLET ORAL 20130614
ANDA ANDA040411 American Health Packaging METHIMAZOLE 5
mg/1 "Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inh
ibitors [MoA]"
68084-276_03cd3cc8-0214-4624-8571-b45e9e3522ab 68084-276 HUMAN PRESCRIPTI
ON DRUG Methimazole Methimazole TABLET ORAL 20130614
ANDA ANDA040411 American Health Packaging METHIMAZOLE 10
mg/1 "Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inh
ibitors [MoA]"
68084-278_14ed41da-9719-40cd-8967-7aa280013610 68084-278 HUMAN PRESCRIPTI
68084-279_14ed41da-9719-40cd-8967-7aa280013610 68084-279 HUMAN PRESCRIPTI
68084-280_d32e9865-8edd-4644-9939-62ed119db3ef 68084-280 HUMAN PRESCRIPTI
ON DRUG Ethambutol Hydrochloride Ethambutol Hydrochloride
Packaging ETHAMBUTOL HYDROCHLORIDE 400 mg/1 Antimycobacteria
l [EPC]
68084-281_a8855b15-e995-4782-a0b8-b563e9c0a3a4 68084-281 HUMAN PRESCRIPTI
ON DRUG Carbidopa and Levodopa Carbidopa and Levodopa "TABLET, EXTENDE
Health Packaging CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 "Aromati
"
68084-282_a8855b15-e995-4782-a0b8-b563e9c0a3a4 68084-282 HUMAN PRESCRIPTI
Health Packaging CARBIDOPA; LEVODOPA 50; 200 mg/1; mg/1 "Aromati
"
68084-283_3a8352f0-569d-4d7e-b42a-392feb9e31a5 68084-283 HUMAN PRESCRIPTI
ON DRUG PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM "TABLET, DELAYED
68084-284_1861b97c-ef26-4eac-ac4b-fee643450cf7 68084-284 HUMAN PRESCRIPTI
ON DRUG Hydroxyurea Hydroxyurea CAPSULE ORAL 20080812
ANDA ANDA075340 American Health Packaging HYDROXYUREA 500
mg/1 "Antimetabolite [EPC],Urea [Chemical/Ingredient]"
68084-286_00fc4909-d33f-4e73-a63d-10058624915b 68084-286 HUMAN PRESCRIPTI
ON DRUG Fexofenadine Hydrochloride Fexofenadine Hydrochloride
Packaging FEXOFENADINE HYDROCHLORIDE 60 mg/1 "Histamine H1 Re
ceptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]"
68084-287_00fc4909-d33f-4e73-a63d-10058624915b 68084-287 HUMAN PRESCRIPTI
Packaging FEXOFENADINE HYDROCHLORIDE 180 mg/1 "Histamine H1 Re
68084-288_001e72ea-2c9e-468c-90cc-6c347234e2a9 68084-288 HUMAN PRESCRIPTI
ON DRUG Fludrocortisone Acetate Fludrocortisone Acetate TABLET ORAL
FLUDROCORTISONE ACETATE 0.1 mg/1
68084-289_8c7c9d05-8cdb-4c00-9809-aa10ec613967 68084-289 HUMAN PRESCRIPTI
ON DRUG MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE
Packaging MINOCYCLINE HYDROCHLORIDE 100 mg/1 "Tetracycline-cl
68084-291_a8e1e7e8-45ee-41de-af32-9a3f8332ca19 68084-291 HUMAN PRESCRIPTI
ON DRUG NALTREXONE HYDROCHLORIDE naltrexone hydrochloride
American Health Packaging NALTREXONE HYDROCHLORIDE 50 mg/1
"Opioid Antagonist [EPC],Opioid Antagonists [MoA]"
68084-292_24220035-37fe-4d90-aae6-f8963fb77fa9 68084-292 HUMAN PRESCRIPTI
ON DRUG Phenazopyridine Hydrochloride Phenazopyridine Hydrochloride
TABLET ORAL 20130624 UNAPPROVED DRUG OTHER American
Health Packaging PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1
68084-293_24220035-37fe-4d90-aae6-f8963fb77fa9 68084-293 HUMAN PRESCRIPTI
ON DRUG Phenazopyridine Hydrochloride Phenazopyridine Hydrochloride
TABLET ORAL 20130624 UNAPPROVED DRUG OTHER American
Health Packaging PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1
ANDA ANDA076549 American Health Packaging RAMIPRIL 1.25
Packaging GLIPIZIDE 2.5 mg/1 "Sulfonylurea [EPC],Sulfonylurea
68084-299_8150a710-aee5-4841-ae1b-7d2e61281a8f 68084-299 HUMAN PRESCRIPTI
ON DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride
Packaging TAMSULOSIN HYDROCHLORIDE 0.4 mg/1 "Adrenergic alph
68084-300_b243682b-78be-4c16-a172-3d631a2c09f1 68084-300 HUMAN PRESCRIPTI
ON DRUG Dantrolene Sodium Dantrolene Sodium CAPSULE ORAL
DANTROLENE SODIUM 25 mg/1 "Decreased Striated Muscle Contraction [
PE],Decreased Striated Muscle Tone [PE],Skeletal Muscle Relaxant [EPC]"
68084-301_7e54c03b-27aa-4006-9e4a-2a2b8800f6ce 68084-301 HUMAN PRESCRIPTI
ON DRUG METOPROLOL SUCCINATE METOPROLOL SUCCINATE "TABLET, FILM CO
American Health Packaging METOPROLOL SUCCINATE 100 mg/1 "Adrener
68084-305_71704334-a1c7-42dc-bfc8-e9cebb02a726 68084-305 HUMAN PRESCRIPTI
American Health Packaging ROPINIROLE HYDROCHLORIDE 1 mg/1
68084-309_23fb4162-2310-486c-ba9f-f7c94b793e56 68084-309 HUMAN PRESCRIPTI
American Health Packaging VALACYCLOVIR HYDROCHLORIDE 1 g/1
68084-310_a8ba3986-1ded-44a8-8d10-d0f252a07794 68084-310 HUMAN PRESCRIPTI
ON DRUG Divalproex Sodium Divalproex Sodium "TABLET, FILM CO
American Health Packaging DIVALPROEX SODIUM 250 mg/1 "Anti-ep
68084-313_1c4ea059-ab57-41ab-90ab-fd50540028a4 68084-313 HUMAN PRESCRIPTI
ON DRUG divalproex sodium divalproex sodium "CAPSULE, COATED
PELLETS" ORAL 20090401 ANDA ANDA078919 American
Health Packaging DIVALPROEX SODIUM 125 mg/1 "Anti-epileptic
68084-314_9fef0f9c-e6ed-4b29-a473-525f2aba70bd 68084-314 HUMAN PRESCRIPTI
ON DRUG Divalproex Sodium DR Divalproex Sodium "TABLET, DELAYED
68084-315_9fef0f9c-e6ed-4b29-a473-525f2aba70bd 68084-315 HUMAN PRESCRIPTI
ON DRUG Divalproex Sodium DR Divalproex Sodium "TABLET, DELAYED
68084-316_3700405c-5743-4c82-a3fb-48dae904eed6 68084-316 HUMAN PRESCRIPTI
ON DRUG DIVALPROEX SODIUM EXTENDED-RELEASE DIVALPROEX SODIUM EXTEND
ED-RELEASE "TABLET, EXTENDED RELEASE" ORAL 20091014
ANDA ANDA078705 American Health Packaging DIVALPROEX SODIUM
68084-317_3700405c-5743-4c82-a3fb-48dae904eed6 68084-317 HUMAN PRESCRIPTI
ON DRUG DIVALPROEX SODIUM EXTENDED-RELEASE DIVALPROEX SODIUM EXTEND
ED-RELEASE "TABLET, EXTENDED RELEASE" ORAL 20091014
ANDA ANDA078705 American Health Packaging DIVALPROEX SODIUM
68084-318_d8becb76-34e6-4330-860e-da67d060bd4e 68084-318 HUMAN PRESCRIPTI
ANDA ANDA077633 American Health Packaging LAMOTRIGINE 25
68084-322_6add39ee-2c4d-4071-b160-8c38b43e86e0 68084-322 HUMAN PRESCRIPTI
ON DRUG ALENDRONATE SODIUM ALENDRONATE SODIUM TABLET ORAL
emical/Ingredient]"
68084-325_f9419de3-5378-49a1-a99c-f47ac4a61094 68084-325 HUMAN PRESCRIPTI
ON DRUG mercaptopurine mercaptopurine TABLET ORAL 20130315
ANDA ANDA040461 American Health Packaging MERCAPTOPURINE 50
mg/1 "Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor
[EPC]"
68084-326_65216872-dc40-41bf-9c2d-ce39417113b2 68084-326 HUMAN PRESCRIPTI
ANDA ANDA077091 American Health Packaging GLIMEPIRIDE 2
68084-328_54ad6573-a334-44d7-a048-53a41e20adf1 68084-328 HUMAN PRESCRIPTI
ON DRUG FENOFIBRATE FENOFIBRATE TABLET ORAL 20090122
ANDA ANDA076509 American Health Packaging FENOFIBRATE 160
68084-329_f6831753-1d65-4f48-9209-d28e05828b1e 68084-329 HUMAN PRESCRIPTI
ON DRUG Fenofibrate FENOFIBRATE CAPSULE ORAL 20130719
68084-330_d94ad2c8-dc26-4d3d-b6a0-0d7069d890b5 68084-330 HUMAN PRESCRIPTI
Packaging VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 "Norepinephrine
Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Se
rotonin Uptake Inhibitors [MoA]"
68084-331_d94ad2c8-dc26-4d3d-b6a0-0d7069d890b5 68084-331 HUMAN PRESCRIPTI
Packaging VENLAFAXINE HYDROCHLORIDE 75 mg/1 "Norepinephrine
68084-333_55bfb3b3-dc73-4e16-833f-b04a163ea96d 68084-333 HUMAN PRESCRIPTI
Health Packaging DICLOFENAC SODIUM 75 mg/1 "Cyclooxygenase
Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-infla
]"
68084-335_fc158f5c-4e60-44b8-adba-fbcbc6e734ec 68084-335 HUMAN PRESCRIPTI
ON DRUG Lamotrigine lamotrigine "TABLET, CHEWABLE" ORAL
LAMOTRIGINE 25 mg/1 "Anti-epileptic Agent [EPC],Decreased Central Ne
rvous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]"
68084-336_4671df2f-7481-4d1b-90eb-10d1e6e7a8c4 68084-336 HUMAN PRESCRIPTI
68084-339_3b517e0e-7848-418c-8599-fce46f3bedcd 68084-339 HUMAN PRESCRIPTI
ON DRUG Sumatriptan Succinate sumatriptan succinate "TABLET, COATED"
g SUMATRIPTAN SUCCINATE 25 mg/1 "Serotonin 1b Receptor Agonists
r Agonist [EPC]"
r Agonist [EPC]"
r Agonist [EPC]"
68084-342_fae90a53-23a8-4b91-9f8a-cc4971f4120d 68084-342 HUMAN PRESCRIPTI
ON DRUG topiramate topiramate "TABLET, FILM COATED" ORAL
20120601 20150327 ANDA ANDA078235 American Health Packagin
g TOPIRAMATE 50 mg/1 "Anti-epileptic Agent [EPC],Decreased Ce
68084-346_6936d50e-ff58-4279-8500-1da491da486d 68084-346 HUMAN PRESCRIPTI
Packaging LOSARTAN POTASSIUM 25 mg/1 "Angiotensin 2 Receptor
68084-349_6d84c3fd-697f-4bc2-aa18-d7a9adcc9ca8 68084-349 HUMAN PRESCRIPTI
ON DRUG Amlodipine Besylate and Benazepril HCL Amlodipine Besylate and
Benazepril HCL CAPSULE ORAL 20100922 ANDA ANDA078466
American Health Packaging AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
5; 10 mg/1; mg/1 "Calcium Channel Antagonists [MoA],Dihydropyridine Calci
um Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Conv
erting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Dec
reased Blood Pressure [PE]"
CIII
68084-354_aa7ac2bf-d9ed-445d-b394-4d3fe39780ca 68084-354 HUMAN PRESCRIPTI
ON DRUG Oxycodone Hydchloride Oxycodone Hydrochloride TABLET ORAL
st [EPC]" CII
68084-355_b5d50907-864c-4bb1-bc80-09ecbacd1818 68084-355 HUMAN PRESCRIPTI
Packaging ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 5 mg/1; mg/1
68084-356_cda0475c-3b86-4328-b8f6-a99a6a2ebc14 68084-356 HUMAN PRESCRIPTI
68084-357_19ee9e18-d437-4bb2-9ad8-75c8f283a2df 68084-357 HUMAN PRESCRIPTI
ON DRUG Rifampin Rifampin CAPSULE ORAL 20090925
ANDA ANDA065390 American Health Packaging RIFAMPIN 150
mg/1 "Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient]"
68084-358_19ee9e18-d437-4bb2-9ad8-75c8f283a2df 68084-358 HUMAN PRESCRIPTI
ON DRUG Rifampin Rifampin CAPSULE ORAL 20090925
ANDA ANDA065390 American Health Packaging RIFAMPIN 300
mg/1 "Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient]"
68084-359_1d1e0f1b-902e-45d6-b50a-12aadd462da5 68084-359 HUMAN PRESCRIPTI
ON DRUG Diazepam Diazepam TABLET ORAL 20091013
ANDA ANDA071135 American Health Packaging DIAZEPAM 5
68084-360_3171e688-3a7f-4b00-a4f4-99b15a51cde3 68084-360 HUMAN PRESCRIPTI
ON DRUG Potassium Chloride potassium chloride "TABLET, EXTENDE
Health Packaging POTASSIUM CHLORIDE 1500 mg/1 "Potassium Compo
68084-361_8c0b74de-bddc-4fbc-bfd0-22ed95ced524 68084-361 HUMAN PRESCRIPTI
ON DRUG Propafenone HCl Propafenone hydrochloride "TABLET, FILM CO
Packaging PROPAFENONE HYDROCHLORIDE 150 mg/1 Antiarrhythmic [
EPC]
CIII
68084-368_43105036-2578-46fb-a092-0b98e40b2a99 68084-368 HUMAN PRESCRIPTI
CIII
68084-371_e6a8ed4f-a343-42d7-a35e-8ad820f3da23 68084-371 HUMAN PRESCRIPTI
ON DRUG AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE
Packaging AMIODARONE HYDROCHLORIDE 200 mg/1 "Antiarrhythmic
[EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytoc
hrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome
P450 2D6 Inhibitors [MoA]"
68084-372_8e68de4c-3d6d-479a-b730-9ff43ab948f4 68084-372 HUMAN PRESCRIPTI
ON DRUG Acetaminophen And Codeine Phosphate acetaminophen and codein
e phosphate TABLET ORAL 20100113 ANDA ANDA089805
American Health Packaging ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30
mg/1; mg/1 "Full Opioid Agonists [MoA],Opioid Agonist [EPC]" CIII
68084-373_8e68de4c-3d6d-479a-b730-9ff43ab948f4 68084-373 HUMAN PRESCRIPTI
ON DRUG Acetaminophen And Codeine Phosphate acetaminophen and codein
American Health Packaging ACETAMINOPHEN; CODEINE PHOSPHATE 300; 60
mg/1; mg/1 "Full Opioid Agonists [MoA],Opioid Agonist [EPC]" CIII
68084-374_acb15f19-762d-497b-9b01-38ff60c4314d 68084-374 HUMAN PRESCRIPTI
ON DRUG Bicalutamide Bicalutamide "TABLET, FILM COATED" ORAL
BICALUTAMIDE 50 mg/1 "Androgen Receptor Antagonists [MoA],Androgen Re
ceptor Inhibitor [EPC]"
68084-375_f85296ab-a104-496f-a23d-e0a88cf91ec7 68084-375 HUMAN PRESCRIPTI
ON DRUG Bromocriptine Mesylate Bromocriptine Mesylate CAPSULE ORAL
BROMOCRIPTINE MESYLATE 5 mg/1 "Ergolines [Chemical/Ingredient],Ergot D
erivative [EPC]"
68084-376_8ca43d7a-aff0-4a22-ba4b-f2b21cad4188 68084-376 HUMAN PRESCRIPTI
ON DRUG Extended Phenytoin Sodium Phenytoin Sodium CAPSULE
g PHENYTOIN SODIUM 100 mg/1 "Anti-epileptic Agent [EPC],Decr
eased Central Nervous System Disorganized Electrical Activity [PE]"
68084-378_8646a797-7a70-463b-aafa-a835b3e381d0 68084-378 HUMAN PRESCRIPTI
ON DRUG Oxycodone and Acetaminophen Oxycodone hydrochloride and Acet
aminophen TABLET ORAL 20090925 ANDA ANDA040535
American Health Packaging ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 10
mg/1; mg/1 "Full Opioid Agonists [MoA],Opioid Agonist [EPC]" CII
68084-379_8646a797-7a70-463b-aafa-a835b3e381d0 68084-379 HUMAN PRESCRIPTI
ON DRUG Oxycodone and Acetaminophen Oxycodone hydrochloride and Acet
aminophen TABLET ORAL 20090925 ANDA ANDA040535
American Health Packaging ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 7.5
68084-380_62096762-af2d-4025-9386-a6b45ca25737 68084-380 HUMAN PRESCRIPTI
ANDA ANDA040245 American Health Packaging CARISOPRODOL 350
CIV
68084-381_82d4396f-91c3-4c46-8e3b-7e8b254a746b 68084-381 HUMAN PRESCRIPTI
ON DRUG Benztropine Mesylate Benztropine Mesylate TABLET ORAL
BENZTROPINE MESYLATE 0.5 mg/1 "Anticholinergic [EPC],Antihistamine [EP
C],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA]"
BENZTROPINE MESYLATE 1 mg/1 "Anticholinergic [EPC],Antihistamine [EP
BENZTROPINE MESYLATE 2 mg/1 "Anticholinergic [EPC],Antihistamine [EP
68084-390_08f90170-f53c-4272-92ae-951cf115e271 68084-390 HUMAN PRESCRIPTI
ON DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL
ENALAPRIL MALEATE 5 mg/1 "Angiotensin Converting Enzyme Inhibitor
[EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [
PE]"
PE]"
PE]"
68084-393_107e852d-500a-4c7a-b5ff-78e3b0f17a91 68084-393 HUMAN PRESCRIPTI
ON DRUG PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN propoxyphene nap
sylate and acetaminophen TABLET ORAL 20090925 ANDA
ANDA074843 American Health Packaging ACETAMINOPHEN; PROPOXYPHENE NAPS
st [EPC]" CIV
68084-396_4d1116c0-1778-4529-b2af-812f17931256 68084-396 HUMAN PRESCRIPTI
ON DRUG "BUTALBITAL, ACETAMINOPHEN AND CAFFEINE" "BUTALBITAL, ACE
TAMINOPHEN AND CAFFEINE" TABLET ORAL 20120601 ANDA
ANDA040511 American Health Packaging ACETAMINOPHEN; BUTALBITAL; CAFFE
INE 325; 50; 40 mg/1; mg/1; mg/1 "Barbiturate [EPC],Barbiturates
[Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous Sys
tem Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient]"
68084-397_14cc23fe-9ea0-4118-ab76-cfa1e9705401 68084-397 HUMAN PRESCRIPTI
ON DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride
American Health Packaging CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1
"Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]"
68084-398_08fc1bae-4196-4cb0-89c9-e99599c61556 68084-398 HUMAN PRESCRIPTI
ON DRUG Hydrochlorothiazide hydrochlorothiazide CAPSULE ORAL
HYDROCHLOROTHIAZIDE 12.5 mg/1 "Increased Diuresis [PE],Thiazide Diuret
68084-399_80a1dd88-3880-45a6-87bf-520dadd96294 68084-399 HUMAN PRESCRIPTI
68084-400_248ab64b-358e-4b59-bd6c-3d1a6b633fcc 68084-400 HUMAN PRESCRIPTI
68084-401_7c9ac4b0-fcac-483e-aaa4-43e76faaa4b7 68084-401 HUMAN PRESCRIPTI
ON DRUG Acetazolamide Acetazolamide "CAPSULE, EXTENDED RELEASE"
g ACETAZOLAMIDE 500 mg/1 "Carbonic Anhydrase Inhibitor [EPC],Carb
onic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient]"
68084-407_b07f23d8-97ec-4a50-984a-b7dea69f9705 68084-407 HUMAN PRESCRIPTI
Packaging TAMSULOSIN HYDROCHLORIDE 0.4 mg/1 "Adrenergic alph
68084-408_1837c22b-f066-470a-95a7-9b1274d0bd14 68084-408 HUMAN PRESCRIPTI
Packaging VALACYCLOVIR HYDROCHLORIDE 500 mg/1 "DNA Polymerase
ical/Ingredient]"
68084-409_1837c22b-f066-470a-95a7-9b1274d0bd14 68084-409 HUMAN PRESCRIPTI
Packaging VALACYCLOVIR HYDROCHLORIDE 1 g/1 "DNA Polymerase
ical/Ingredient]"
68084-411_79ca69d5-7e5d-4303-8f4e-321b0bed131e 68084-411 HUMAN PRESCRIPTI
g INDOMETHACIN 75 mg/1 "Cyclooxygenase Inhibitors [MoA],Nonster
matory Drug [EPC]"
68084-412_f0db00dd-d63e-4111-aec2-240304acc71a 68084-412 HUMAN PRESCRIPTI
68084-415_a8ba3986-1ded-44a8-8d10-d0f252a07794 68084-415 HUMAN PRESCRIPTI
ON DRUG Divalproex Sodium Divalproex Sodium "TABLET, FILM CO
American Health Packaging DIVALPROEX SODIUM 500 mg/1 "Anti-ep
68084-416_d9370dfc-283b-4a91-8e5e-18c35d2a78e6 68084-416 HUMAN PRESCRIPTI
ON DRUG Lamivudine and Zidovudine Lamivudine and Zidovudine
American Health Packaging LAMIVUDINE; ZIDOVUDINE 150; 300 mg/1; mg
/1 "Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EP
C],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibito
r [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase
Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcr
iptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Revers
e Transcriptase Inhibitors [MoA]"
68084-417_34868f95-78d0-4089-8cbd-bec1cb730eda 68084-417 HUMAN PRESCRIPTI
ON DRUG Metolazone Metolazone TABLET ORAL 20101004
ANDA ANDA076732 American Health Packaging METOLAZONE 2.5
mg/1 "Increased Diuresis [PE],Thiazide-like Diuretic [EPC]"
68084-418_34868f95-78d0-4089-8cbd-bec1cb730eda 68084-418 HUMAN PRESCRIPTI
ON DRUG Metolazone Metolazone TABLET ORAL 20101004
ANDA ANDA076466 American Health Packaging METOLAZONE 5
68084-419_4b06f42e-d61e-406a-ac32-370b2967dd64 68084-419 HUMAN PRESCRIPTI
ON DRUG potassium chloride potassium chloride "CAPSULE, EXTEND
8 American Health Packaging POTASSIUM CHLORIDE 750 mg/1
"Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC]"
68084-420_8e86b2c6-b449-4abc-97fb-e78702bb1b83 68084-420 HUMAN PRESCRIPTI
68084-423_79c10b70-fca5-4333-b21f-5eeb10aa93f1 68084-423 HUMAN PRESCRIPTI
Packaging HYDROMORPHONE HYDROCHLORIDE 2 mg/1 "Full Opioid Ago
68084-424_b3d24364-f4fc-4aac-ac5c-651ae7f6f9b6 68084-424 HUMAN PRESCRIPTI
ON DRUG Oxandrolone oxandrolone TABLET ORAL 20130624
ANDA ANDA077827 American Health Packaging OXANDROLONE 2.5
mg/1 CIII
68084-430_11a432b9-2374-4bdc-ac9b-9f45fb942905 68084-430 HUMAN OTC DRUG
healthylax Polyethylene Glycol 3350 "POWDER, FOR SOLUTION"
g POLYETHYLENE GLYCOL 3350 17 g/17g
68084-431_09aee1f2-d5f0-4544-9949-14e425219220 68084-431 HUMAN PRESCRIPTI
68084-432_09aee1f2-d5f0-4544-9949-14e425219220 68084-432 HUMAN PRESCRIPTI
68084-435_7d7a0453-5216-49c0-8861-f28f10f13b1b 68084-435 HUMAN PRESCRIPTI
ON DRUG Isosorbide mononitrate Isosorbide mononitrate "TABLET, FILM CO
American Health Packaging ISOSORBIDE MONONITRATE 30 mg/1 "Nitrate
Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE]"
68084-436_7d7a0453-5216-49c0-8861-f28f10f13b1b 68084-436 HUMAN PRESCRIPTI
ON DRUG Isosorbide mononitrate Isosorbide mononitrate "TABLET, FILM CO
American Health Packaging ISOSORBIDE MONONITRATE 60 mg/1 "Nitrate
Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE]"
68084-437_e0631ff1-5b29-42d5-a07b-88ded6871201 68084-437 HUMAN PRESCRIPTI
68084-440_5b15a21d-cde6-4c9f-b9b2-b747ded70931 68084-440 HUMAN PRESCRIPTI
ON DRUG PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE
Packaging PRAMIPEXOLE DIHYDROCHLORIDE 0.25 mg/1 "Dopamine Agonis
ts [MoA],Nonergot Dopamine Agonist [EPC]"
68084-443_84629614-e14c-47c9-b642-c6aa8b431929 68084-443 HUMAN PRESCRIPTI
68084-444_1dd3d934-efee-4fdb-ae6f-f47b61831a2e 68084-444 HUMAN PRESCRIPTI
ON DRUG CARBAMAZEPINE CARBAMAZEPINE TABLET ORAL 20140415
ANDA ANDA075948 American Health Packaging CARBAMAZEPINE 200
oA]"
68084-446_508b2795-d004-4678-9ff2-950b4bb27b8d 68084-446 HUMAN PRESCRIPTI
ON DRUG Nitrofurantoin (monohydrate/macrocrystals) Nitrofurantoin (
monohydrate/macrocrystals) CAPSULE ORAL 20101007 ANDA
ANDA080043 American Health Packaging NITROFURANTOIN; NITROFURANTOIN M
ONOHYDRATE 25; 75 mg/1; mg/1 "Nitrofuran Antibacterial [EPC],Nitrofur
ans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/I
ngredient]"
68084-447_331dc218-2ef7-4735-9823-f84529b3bb06 68084-447 HUMAN PRESCRIPTI
68084-448_d1be67b7-61c0-4620-b877-17f7fae0a3b4 68084-448 HUMAN PRESCRIPTI
ON DRUG Anastrozole Anastrozole "TABLET, COATED" ORAL
ANASTROZOLE 1 mg/1 "Aromatase Inhibitor [EPC],Aromatase Inhibitors
[MoA]"
68084-449_61322a53-f4f6-40ad-84e8-7a85d7705a59 68084-449 HUMAN PRESCRIPTI
ANDA ANDA090509 American Health Packaging TACROLIMUS 0.5
oA]"
ANDA ANDA090509 American Health Packaging TACROLIMUS 1
oA]"
ANDA ANDA090509 American Health Packaging TACROLIMUS 5
oA]"
68084-458_047035e5-59c8-42eb-8a34-da63dcbbf09f 68084-458 HUMAN PRESCRIPTI
ON DRUG Nateglinide Nateglinide "TABLET, COATED" ORAL
NATEGLINIDE 60 mg/1 "Glinide [EPC],Potassium Channel Antagonists [Mo
A]"
68084-459_047035e5-59c8-42eb-8a34-da63dcbbf09f 68084-459 HUMAN PRESCRIPTI
ON DRUG Nateglinide Nateglinide "TABLET, COATED" ORAL
NATEGLINIDE 120 mg/1 "Glinide [EPC],Potassium Channel Antagonists [Mo
A]"
68084-461_24275018-b4b3-4778-bd4d-73de5e558714 68084-461 HUMAN PRESCRIPTI
ON DRUG Zidovudine zidovudine CAPSULE ORAL 20130705
ANDA ANDA078128 American Health Packaging ZIDOVUDINE 100
mg/1 "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase In
hibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcr
iptase Inhibitors [MoA]"
68084-462_f4534f59-77b6-4a4c-ae64-efed3175ca90 68084-462 HUMAN PRESCRIPTI
ON DRUG Zidovudine Zidovudine "TABLET, FILM COATED" ORAL
ZIDOVUDINE 300 mg/1 "Human Immunodeficiency Virus Nucleoside Analog
Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nu
cleoside Reverse Transcriptase Inhibitors [MoA]"
68084-463_820ad6a8-a5c7-4e3b-a6d0-bbf6c04bab56 68084-463 HUMAN PRESCRIPTI
ON DRUG Ergocalciferol Ergocalciferol CAPSULE ORAL 20110107
ANDA ANDA040833 American Health Packaging ERGOCALCIFEROL 1.25
68084-464_62d24da1-2011-460d-a2f8-546049219070 68084-464 HUMAN PRESCRIPTI
68084-466_5e9364c6-6fe1-4c7f-af32-6592c58c1a6c 68084-466 HUMAN PRESCRIPTI
68084-467_4b3d430e-e439-4b59-b6d7-5da9b5d24b54 68084-467 HUMAN PRESCRIPTI
ON DRUG Lansoprazole lansoprazole "CAPSULE, DELAYED RELEASE PELLET
S" ORAL 20100915 ANDA ANDA091269 American Health
Packaging LANSOPRAZOLE 15 mg/1 "Proton Pump Inhibitor [EPC],Pro
68084-468_4b3d430e-e439-4b59-b6d7-5da9b5d24b54 68084-468 HUMAN PRESCRIPTI
ON DRUG Lansoprazole lansoprazole "CAPSULE, DELAYED RELEASE PELLET
S" ORAL 20100915 ANDA ANDA090763 American Health
Packaging LANSOPRAZOLE 30 mg/1 "Proton Pump Inhibitor [EPC],Pro
68084-469_41959de4-8732-43f9-9312-bcff4530c258 68084-469 HUMAN PRESCRIPTI
ON DRUG Hydrocortisone hydrocortisone TABLET ORAL 20110401
ANDA ANDA040761 American Health Packaging HYDROCORTISONE 10
68084-470_55d53a9b-fc92-4acf-be34-7daf1a6f2570 68084-470 HUMAN PRESCRIPTI
68084-471_55d53a9b-fc92-4acf-be34-7daf1a6f2570 68084-471 HUMAN PRESCRIPTI
68084-472_79c10b70-fca5-4333-b21f-5eeb10aa93f1 68084-472 HUMAN PRESCRIPTI
Packaging HYDROMORPHONE HYDROCHLORIDE 4 mg/1 "Full Opioid Ago
68084-473_57688690-1ceb-4c4a-b9a0-f8389dedd38b 68084-473 HUMAN PRESCRIPTI
ON DRUG GEMFIBROZIL GEMFIBROZIL "TABLET, FILM COATED" ORAL
GEMFIBROZIL 600 mg/1 "Peroxisome Proliferator Receptor alpha Agonist
[EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha
68084-475_c5bf5233-605b-42d7-b9f8-fe29c63331c9 68084-475 HUMAN PRESCRIPTI
ON DRUG Calcitriol Calcitriol CAPSULE ORAL 20120301
ANDA ANDA076917 American Health Packaging CALCITRIOL 0.25
ug/1 "Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC]"
68084-477_7889f006-4fcd-4d12-898c-8d20c54dd519 68084-477 HUMAN PRESCRIPTI
Packaging DONEPEZIL HYDROCHLORIDE 5 mg/1 "Cholinesterase Inhibito
68084-478_7889f006-4fcd-4d12-898c-8d20c54dd519 68084-478 HUMAN PRESCRIPTI
68084-479_1090762c-eec1-4ab0-9ddc-43caa764cd0e 68084-479 HUMAN PRESCRIPTI
ON DRUG Calcium Acetate Calcium Acetate CAPSULE ORAL 20130726
ANDA ANDA077728 American Health Packaging CALCIUM ACETATE 667
mg/1 "Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [P
E],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient]"
68084-479_bb5785a3-ba5b-43b6-9c65-07c56766a3eb 68084-479 HUMAN PRESCRIPTI
ANDA ANDA077728 American Health Packaging CALCIUM ACETATE 667
68084-480_8ade9de4-67ea-42ef-b576-ee517ca2acab 68084-480 HUMAN PRESCRIPTI
ON DRUG Oxybutynin Chloride Extended Release Oxybutynin Chloride
03 American Health Packaging OXYBUTYNIN CHLORIDE 5 mg/1
"Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA
]"
68084-481_8e3d585c-25b9-4940-b309-82548b8d33cd 68084-481 HUMAN PRESCRIPTI
ON DRUG Levofloxacin Levofloxacin "TABLET, FILM COATED" ORAL
LEVOFLOXACIN 250 mg/1
68084-484_1a5fd3dc-2f46-4884-95df-80b8a46c7e41 68084-484 HUMAN PRESCRIPTI
ON DRUG VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE
65 American Health Packaging VENLAFAXINE HYDROCHLORIDE 37.5
65 American Health Packaging VENLAFAXINE HYDROCHLORIDE 75
68084-487_7cf72e59-f83e-4d4d-a96a-820377eb3c66 68084-487 HUMAN PRESCRIPTI
ON DRUG bisoprolol fumarate bisoprolol fumarate "TABLET, COATED"
g BISOPROLOL FUMARATE 5 mg/1 "Adrenergic beta-Antagonists [Mo
68084-490_d85f2ccb-95b1-42f6-a4c0-12ac945ca099 68084-490 HUMAN PRESCRIPTI
ON DRUG Meclizine Hydrochloride Meclizine Hydrochloride TABLET ORAL
MECLIZINE HYDROCHLORIDE 12.5 mg/1 "Antiemetic [EPC],Emesis Suppression [PE
]"
68084-491_d85f2ccb-95b1-42f6-a4c0-12ac945ca099 68084-491 HUMAN PRESCRIPTI
]"
68084-492_d5b373a6-f36e-40be-8028-53c586e3bdeb 68084-492 HUMAN PRESCRIPTI
ON DRUG Galantamine Galantamine "TABLET, FILM COATED" ORAL
g GALANTAMINE HYDROBROMIDE 4 mg/1 "Cholinesterase Inhibito
68084-494_64ed79b7-9439-483c-9f56-07155a5d24d7 68084-494 HUMAN PRESCRIPTI
ON DRUG Pyridostigmine Bromide PYRIDOSTIGMINE BROMIDE TABLET ORAL
PYRIDOSTIGMINE BROMIDE 60 mg/1 "Cholinesterase Inhibitor [EPC],Cholines
68084-496_0b701d23-9a0a-4d56-a180-2a5a5e3e0c0f 68084-496 HUMAN PRESCRIPTI
ON DRUG TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TRAMADOL HYDROCH
LORIDE AND ACETAMINOPHEN "TABLET, FILM COATED" ORAL 20120301
ANDA ANDA077184 American Health Packaging ACETAMINOPHEN; TRAMADOL
HYDROCHLORIDE 325; 37.5 mg/1; mg/1 "Full Opioid Agonists [MoA],Opio
id Agonist [EPC]"
68084-497_9db6a76f-6745-4f26-8fb3-cbf6743a360c 68084-497 HUMAN PRESCRIPTI
ON DRUG sotalol hydrochloride sotalol hydrochloride TABLET ORAL
68084-498_0d1a3686-d8d7-43a3-b38d-df5e6cf71cfa 68084-498 HUMAN PRESCRIPTI
ON DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL
68084-499_b5650ad5-471d-4639-b8da-bdb3d990c627 68084-499 HUMAN PRESCRIPTI
ON DRUG Glycopyrrolate glycopyrrolate TABLET ORAL 20110901
ANDA ANDA040653 American Health Packaging GLYCOPYRROLATE 1
mg/1
68084-500_581f17c6-1d7d-4bf3-9ef7-537a222d0ac1 68084-500 HUMAN PRESCRIPTI
68084-503_0225559a-7788-4065-8a79-071d408b4c68 68084-503 HUMAN PRESCRIPTI
ON DRUG Propranolol Hydrochloride ER propranolol hydrochloride
"CAPSULE, EXTENDED RELEASE" ORAL 20130705 NDA AUTHORIZED G
ENERIC NDA018553 American Health Packaging PROPRANOLOL HYDROCHLORID
E 60 mg/1 "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Block
er [EPC]"
68084-504_0225559a-7788-4065-8a79-071d408b4c68 68084-504 HUMAN PRESCRIPTI
ON DRUG Propranolol Hydrochloride ER propranolol hydrochloride
ENERIC NDA018553 American Health Packaging PROPRANOLOL HYDROCHLORID
E 80 mg/1 "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Block
er [EPC]"
68084-508_2ac2f4ec-78a3-45c4-b2ad-056611df5ad2 68084-508 HUMAN PRESCRIPTI
ON DRUG Digoxin Digoxin TABLET ORAL 20110701 ANDA
ANDA077002 American Health Packaging DIGOXIN 125 ug/1 "Cardiac
68084-509_2ac2f4ec-78a3-45c4-b2ad-056611df5ad2 68084-509 HUMAN PRESCRIPTI
ANDA077002 American Health Packaging DIGOXIN 250 ug/1 "Cardiac
68084-510_1d2ff499-ad1a-42b7-80b1-40ac7b9dd391 68084-510 HUMAN PRESCRIPTI
ON DRUG Simvastatin Simvastatin TABLET ORAL 20110502
ANDA ANDA078103 American Health Packaging SIMVASTATIN 5
nhibitors [MoA]"
nhibitors [MoA]"
nhibitors [MoA]"
nhibitors [MoA]"
nhibitors [MoA]"
68084-519_f5882b3b-f93b-4ebf-893a-22ff17315e08 68084-519 HUMAN PRESCRIPTI
American Health Packaging HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg
redient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting En
68084-520_331dc218-2ef7-4735-9823-f84529b3bb06 68084-520 HUMAN PRESCRIPTI
68084-521_776ccac6-471d-4c41-8c52-a8e90bd832c5 68084-521 HUMAN PRESCRIPTI
ON DRUG Nifedipine Nifedipine CAPSULE ORAL 20120201
ANDA ANDA072781 American Health Packaging NIFEDIPINE 10
mg/1 "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Block
er [EPC],Dihydropyridines [Chemical/Ingredient]"
68084-523_37c75ab5-9134-4805-a87d-457fa1d7abcd 68084-523 HUMAN PRESCRIPTI
American Health Packaging ZOLPIDEM TARTRATE 12.5 mg/1 "gamma-A
minobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/I
ngredient],Central Nervous System Depression [PE]" CIV
68084-524_981ca9d3-5dd4-46ab-a799-3506e7b89111 68084-524 HUMAN PRESCRIPTI
NDA018279 American Health Packaging POTASSIUM CHLORIDE 750
mg/1 "Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC]"
68084-525_aa688a7c-1e13-4c36-ba0f-2e5b5978f2a4 68084-525 HUMAN PRESCRIPTI
ON DRUG Olanzapine Olanzapine "TABLET, FILM COATED" ORAL
OLANZAPINE 2.5 mg/1 Atypical Antipsychotic [EPC]
g OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC]
g OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC]
68084-528_c2c67375-9e7a-407f-be86-3fad7ec024ca 68084-528 HUMAN PRESCRIPTI
OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC]
68084-529_c2c67375-9e7a-407f-be86-3fad7ec024ca 68084-529 HUMAN PRESCRIPTI
68084-530_752fd16b-84c4-4cee-8eff-3e7ae47932cd 68084-530 HUMAN PRESCRIPTI
Packaging QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [
EPC]
EPC]
EPC]
EPC]
EPC]
EPC]
68084-536_65ea4dc6-acb2-4609-9a4c-4866ef0ccb11 68084-536 HUMAN PRESCRIPTI
ON DRUG Clopidogrel clopidogrel bisulfate "TABLET, FILM COATED"
g CLOPIDOGREL BISULFATE 75 mg/1 "Decreased Platelet Aggregation
68084-537_01af55ee-a92f-4e67-a14f-3621da3ed3f5 68084-537 HUMAN PRESCRIPTI
ON DRUG Clopidogrel Clopidogrel "TABLET, FILM COATED" ORAL
68084-538_5374a4cc-7b97-44aa-a41d-e8785fc06ef3 68084-538 HUMAN PRESCRIPTI
ON DRUG voriconazole voriconazole "TABLET, FILM COATED" ORAL
VORICONAZOLE 200 mg/1 "Azole Antifungal [EPC],Azoles [Chemical/Ingredi
ent]"
68084-539_93f183c7-d74a-456d-af20-937fae97d8dc 68084-539 HUMAN PRESCRIPTI
ON DRUG Torsemide Torsemide TABLET ORAL 20130722
ANDA ANDA079234 American Health Packaging TORSEMIDE 20
68084-540_0904aa6b-c1cc-4137-87d0-d18ec6a69c54 68084-540 HUMAN PRESCRIPTI
ON DRUG Flecainide Acetate Flecainide Acetate TABLET ORAL
FLECAINIDE ACETATE 100 mg/1 Antiarrhythmic [EPC]
68084-541_7bcb16ee-2233-462c-bf6f-4d55eecbed29 68084-541 HUMAN PRESCRIPTI
ON DRUG AcetaZOLAMIDE Acetazolamide TABLET ORAL 20111101
ANDA ANDA084840 American Health Packaging ACETAZOLAMIDE 250
mg/1 "Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],
Sulfonamides [Chemical/Ingredient]"
68084-542_09796ddd-64db-417d-9bfb-94b6300187a3 68084-542 HUMAN PRESCRIPTI
rug [EPC]"
68084-548_60a860cb-b338-4a8a-938e-7b1e35ed697a 68084-548 HUMAN PRESCRIPTI
ON DRUG Lithium Carbonate ER Lithium Carbonate TABLET ORAL
LITHIUM CARBONATE 450 mg/1
68084-549_96e5cd36-b10b-49ab-a867-91bd9a1b64ca 68084-549 HUMAN PRESCRIPTI
ON DRUG TEMAZEPAM temazepam CAPSULE ORAL 20120201
NDA NDA018163 American Health Packaging TEMAZEPAM 7.5
68084-550_d2690b7a-94d7-42f9-acb5-9556f70fe364 68084-550 HUMAN PRESCRIPTI
ON DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL
RIVASTIGMINE TARTRATE 1.5 mg/1 "Cholinesterase Inhibitor [EPC],Cholines
68084-551_d80883d0-5469-4bde-8bcb-ed65127a7555 68084-551 HUMAN PRESCRIPTI
ON DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL
ISOSORBIDE DINITRATE 30 mg/1
68084-552_1b515565-a311-4d1a-a2ce-02b16bdb74a5 68084-552 HUMAN PRESCRIPTI
ON DRUG Ketoconazole ketoconazole TABLET ORAL 20120120
ANDA ANDA075597 American Health Packaging KETOCONAZOLE 200
mg/1 "Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4
[MoA]"
68084-553_1bf2e449-af17-4cec-95bf-57f794b8f600 68084-553 HUMAN PRESCRIPTI
ON DRUG medroxyprogesterone acetate MEDROXYPROGESTERONE ACETATE
American Health Packaging MEDROXYPROGESTERONE ACETATE 2.5 mg/1
68084-554_fde7483c-1c37-43f0-b905-c68fcc05a6fd 68084-554 HUMAN PRESCRIPTI
ON DRUG Methylergonovine Maleate Methylergonovine Maleate
Packaging METHYLERGONOVINE MALEATE 0.2 mg/1 "Ergolines [Chem
ical/Ingredient],Ergot Derivative [EPC]"
68084-555_b6f5819b-a668-4696-99c8-4ff13b67e062 68084-555 HUMAN PRESCRIPTI
68084-556_c8e26b95-96f4-4b0d-929d-31dd240cfe44 68084-556 HUMAN PRESCRIPTI
ON DRUG Tolazamide tolazamide TABLET ORAL 20120213
ANDA ANDA070259 American Health Packaging TOLAZAMIDE 250
68084-558_a7f953d6-3cc7-46bc-b8fb-b98c9a459b01 68084-558 HUMAN PRESCRIPTI
ANDA ANDA075828 American Health Packaging LOVASTATIN 10
nhibitors [MoA]"
nhibitors [MoA]"
nhibitors [MoA]"
68084-561_eb16404e-48e9-4bd9-a948-7c270f57ff0f 68084-561 HUMAN PRESCRIPTI
ON DRUG Carbamazepine ER Carbamazepine "TABLET, EXTENDED RELEASE"
ORAL 20130624 NDA AUTHORIZED GENERIC NDA020234 American
68084-562_eb16404e-48e9-4bd9-a948-7c270f57ff0f 68084-562 HUMAN PRESCRIPTI
ON DRUG Carbamazepine ER Carbamazepine "TABLET, EXTENDED RELEASE"
ORAL 20130624 NDA AUTHORIZED GENERIC NDA020234 American
68084-563_8aa844f5-1123-466f-86d4-735a9144288b 68084-563 HUMAN PRESCRIPTI
68084-564_ebefc0af-b7f4-4a84-8af3-a42b3b4f3a56 68084-564 HUMAN PRESCRIPTI
American Health Packaging ATORVASTATIN CALCIUM 10 mg/1 "HMG-CoA
68084-567_7b35ba9d-5cf5-47d8-b8f4-4e68c80cb3a6 68084-567 HUMAN PRESCRIPTI
ON DRUG Lithium Carbonate Lithium Carbonate "TABLET, FILM CO
American Health Packaging LITHIUM CARBONATE 300 mg/1 Mood Sta
bilizer [EPC]
68084-568_6e71e169-bc37-4a1f-bb7d-05bb55345742 68084-568 HUMAN PRESCRIPTI
ON DRUG ASACOL mesalamine "TABLET, DELAYED RELEASE" ORAL
20120123 NDA NDA019651 American Health Packaging
MESALAMINE 400 mg/1 "Aminosalicylate [EPC],Aminosalicylic Acids [Che
mical/Ingredient]"
68084-571_0e5bc1a3-6e3c-4ab9-856f-fd953eacf867 68084-571 HUMAN PRESCRIPTI
ON DRUG Isordil Titradose isosorbide dinitrate TABLET ORAL 20120213
NDA NDA012093 American Health Packaging ISOSORBIDE DINITRATE
40 mg/1
68084-577_3a0571c5-97d9-413d-a0c9-549c314913ab 68084-577 HUMAN PRESCRIPTI
ON DRUG RANITIDINE RANITIDINE HYDROCHLORIDE TABLET ORAL
RANITIDINE HYDROCHLORIDE 150 mg/1 "Histamine H2 Receptor Antagonis
ts [MoA],Histamine-2 Receptor Antagonist [EPC]"
68084-578_b77dd52f-3506-445c-989b-916f844633f6 68084-578 HUMAN PRESCRIPTI
ON DRUG Lamivudine Lamivudine "TABLET, FILM COATED" ORAL
LAMIVUDINE 150 mg/1 "Hepatitis B Virus Nucleoside Analog Reverse Tra
nscriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Revers
e Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleosi
de Reverse Transcriptase Inhibitors [MoA]"
68084-580_09853e2b-6b8c-4a03-b458-5fd988b36d7b 68084-580 HUMAN PRESCRIPTI
ANDA ANDA077031 American Health Packaging CITALOPRAM HYDROBROMIDE
[MoA]"
68084-581_1ee99454-fcea-4c72-a75b-497263135bd9 68084-581 HUMAN PRESCRIPTI
ON DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride
Packaging ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsy
chotic [EPC]
chotic [EPC]
chotic [EPC]
chotic [EPC]
68084-585_3e386559-d0dc-4555-8be9-54c8dd3266cf 68084-585 HUMAN PRESCRIPTI
68084-586_3e386559-d0dc-4555-8be9-54c8dd3266cf 68084-586 HUMAN PRESCRIPTI
68084-587_69387493-05b8-4e9a-a478-973bfe92c8e4 68084-587 HUMAN PRESCRIPTI
68084-588_69387493-05b8-4e9a-a478-973bfe92c8e4 68084-588 HUMAN PRESCRIPTI
ON DRUG Mycophenolate Mofetil Mycophenolate Mofetil "TABLET, COATED"
g MYCOPHENOLATE MOFETIL 500 mg/1 Antimetabolite Immunosuppressant
[EPC]
68084-591_346b8ab5-e58c-44a3-80cb-16a8c882eac8 68084-591 HUMAN PRESCRIPTI
ON DRUG isosorbide mononitrate isosorbide mononitrate "TABLET, EXTENDE
Health Packaging ISOSORBIDE MONONITRATE 30 mg/1 "Nitrate Vasodil
ator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE]"
68084-592_346b8ab5-e58c-44a3-80cb-16a8c882eac8 68084-592 HUMAN PRESCRIPTI
Health Packaging ISOSORBIDE MONONITRATE 60 mg/1 "Nitrate Vasodil
ator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE]"
68084-593_d498024c-a0b6-4c8c-8f70-9df654d4b64a 68084-593 HUMAN PRESCRIPTI
ON DRUG Sucralfate Sucralfate TABLET ORAL 20120301
ANDA ANDA074415 American Health Packaging SUCRALFATE 1
g/1 "Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient]"
68084-596_2b872b24-4a06-482e-8716-93d616ccded2 68084-596 HUMAN PRESCRIPTI
ON DRUG PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM "TABLET, DELAYED
68084-597_b11026f8-dea0-49ac-8725-0ef7dc27923f 68084-597 HUMAN PRESCRIPTI
Packaging NIFEDIPINE 30 mg/1 "Calcium Channel Antagonists [Mo
edient]"
edient]"
68084-599_816a6c5d-fa2f-4b0c-8054-6eebfe20363b 68084-599 HUMAN PRESCRIPTI
ic Agonist [EPC]"
68084-600_816a6c5d-fa2f-4b0c-8054-6eebfe20363b 68084-600 HUMAN PRESCRIPTI
ic Agonist [EPC]"
68084-601_9a0f42db-bc69-4a7f-bdc8-aa90c45d1720 68084-601 HUMAN PRESCRIPTI
oA]" CIII
68084-602_ecc8a311-1cb2-4dfa-a092-0b34f7ba30f6 68084-602 HUMAN PRESCRIPTI
ON DRUG Perphenazine perphenazine "TABLET, FILM COATED" ORAL
PERPHENAZINE 4 mg/1 "Phenothiazine [EPC],Phenothiazines [Chemical/In
gredient]"
edient]"
68084-604_920cfea6-2717-4827-a280-d72fc69e8312 68084-604 HUMAN PRESCRIPTI
68084-605_ec81c914-34b5-4fef-88be-4bc6b1185d05 68084-605 HUMAN PRESCRIPTI
68084-606_920cfea6-2717-4827-a280-d72fc69e8312 68084-606 HUMAN PRESCRIPTI
68084-607_ecc8a311-1cb2-4dfa-a092-0b34f7ba30f6 68084-607 HUMAN PRESCRIPTI
ON DRUG Perphenazine perphenazine "TABLET, FILM COATED" ORAL
PERPHENAZINE 8 mg/1 "Phenothiazine [EPC],Phenothiazines [Chemical/In
gredient]"
68084-608_61e51d10-eceb-48e6-b7a0-c3fa92385bf0 68084-608 HUMAN PRESCRIPTI
68084-609_488e765a-7f2d-4323-8a5c-114a46862e8f 68084-609 HUMAN PRESCRIPTI
g CLOPIDOGREL BISULFATE 75 mg/1 "Decreased Platelet Aggregation
68084-610_8ade9de4-67ea-42ef-b576-ee517ca2acab 68084-610 HUMAN PRESCRIPTI
03 American Health Packaging OXYBUTYNIN CHLORIDE 10 mg/1
"Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA
]"
68084-611_ecf99864-ddea-4f29-8b0e-75d58f0a5c60 68084-611 HUMAN PRESCRIPTI
Packaging AMANTADINE HYDROCHLORIDE 100 mg/1 "Influenza A M2
68084-612_aeb2641f-4842-43ff-a4d8-d01b4ab3f47b 68084-612 HUMAN PRESCRIPTI
ANDA ANDA079110 American Health Packaging BICALUTAMIDE 50
mg/1 "Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC]"
68084-613_21ec48c2-ced0-4eb3-ab4b-08a3852ff1fe 68084-613 HUMAN PRESCRIPTI
ON DRUG Pioglitazone Hydrochloride Pioglitazone Hydrochloride
Packaging PIOGLITAZONE HYDROCHLORIDE 15 mg/1 "Peroxisome Prol
iferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Ago
nist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha
[Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],T
hiazolidinediones [Chemical/Ingredient]"
68084-617_eb1691ac-d8e3-4409-ae02-d7e1d9c69153 68084-617 HUMAN PRESCRIPTI
ON DRUG Escitalopram Escitalopram Oxalate "TABLET, FILM COATED"
g ESCITALOPRAM OXALATE 10 mg/1 "Serotonin Reuptake Inhibitor [E
68084-618_eb1691ac-d8e3-4409-ae02-d7e1d9c69153 68084-618 HUMAN PRESCRIPTI
g ESCITALOPRAM OXALATE 20 mg/1 "Serotonin Reuptake Inhibitor [E
68084-619_472301fd-d9db-476e-bd0c-d3cdc9389b8b 68084-619 HUMAN PRESCRIPTI
ON DRUG Montelukast Sodium Montelukast Sodium "TABLET, CHEWABL
E" ORAL 20120702 ANDA ANDA201508 American Health
Packaging MONTELUKAST SODIUM 5 mg/1 "Leukotriene Receptor An
68084-621_90ece2f8-9d69-49a6-9c79-7fa628acb31f 68084-621 HUMAN PRESCRIPTI
ON DRUG Modafinil Modafinil TABLET ORAL 20140401
ANDA ANDA202566 American Health Packaging MODAFINIL 100
mg/1 "Central Nervous System Stimulation [PE],Increased Sympathetic Activity
[PE],Sympathomimetic-like Agent [EPC]" CIV
68084-622_19f9c778-3b40-4e48-ab6e-b4290514a382 68084-622 HUMAN PRESCRIPTI
ON DRUG Sildenafil Citrate Sildenafil Citrate "TABLET, FILM CO
Packaging SILDENAFIL CITRATE 20 mg/1 "Phosphodiesterase 5 Inh
ibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]"
68084-623_e048083f-43ee-41d6-b4a4-27f0f8e8dddf 68084-623 HUMAN PRESCRIPTI
ON DRUG Minocycline Hydrochloride Minocycline Hydrochloride
Packaging MINOCYCLINE HYDROCHLORIDE 100 mg/1 "Tetracycline-cl
68084-624_4cc679fd-98f0-4cd8-bac4-e52a07868c92 68084-624 HUMAN PRESCRIPTI
68084-625_4cc679fd-98f0-4cd8-bac4-e52a07868c92 68084-625 HUMAN PRESCRIPTI
68084-629_0bba1c9c-6d8b-4cb2-9682-9f3ae6d792b9 68084-629 HUMAN PRESCRIPTI
American Health Packaging PIOGLITAZONE HYDROCHLORIDE 15 mg/1
"Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Re
ceptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [
MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolid
inedione [EPC],Thiazolidinediones [Chemical/Ingredient]"
68084-632_3eebec68-25af-4d09-bd69-aee3429ddd58 68084-632 HUMAN PRESCRIPTI
ON DRUG Potassium Chloride Potassium Chloride "TABLET, EXTENDE
Health Packaging POTASSIUM CHLORIDE 10 meq/1 "Potassium Compo
68084-633_6605aaf0-7388-4f92-8499-2777aac23851 68084-633 HUMAN PRESCRIPTI
American Health Packaging VALACYCLOVIR HYDROCHLORIDE 500 mg/1
68084-634_6605aaf0-7388-4f92-8499-2777aac23851 68084-634 HUMAN PRESCRIPTI
"TABLET, FILM COATED" ORAL 20121129 20151111 ANDA ANDA0902
16 American Health Packaging VALACYCLOVIR HYDROCHLORIDE 1
g/1 "DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog
68084-635_df4cb252-a5f1-41f9-ae54-02f9c8740fc8 68084-635 HUMAN PRESCRIPTI
ON DRUG Fenofibrate Fenofibrate TABLET ORAL 20130131
68084-636_df4cb252-a5f1-41f9-ae54-02f9c8740fc8 68084-636 HUMAN PRESCRIPTI
ON DRUG Fenofibrate Fenofibrate TABLET ORAL 20130131
E" ORAL 20130522 ANDA ANDA201508 American Health
68084-642_5374a4cc-7b97-44aa-a41d-e8785fc06ef3 68084-642 HUMAN PRESCRIPTI
ON DRUG voriconazole voriconazole "TABLET, FILM COATED" ORAL
VORICONAZOLE 50 mg/1 "Azole Antifungal [EPC],Azoles [Chemical/Ingredi
ent]"
68084-643_3cf69986-da42-4331-bbbb-5c97326ae3be 68084-643 HUMAN PRESCRIPTI
68084-644_bba6b8f0-daf5-4b0b-bd07-4f59aa679077 68084-644 HUMAN PRESCRIPTI
ANDA ANDA203081 American Health Packaging IRBESARTAN 150
[EPC]"
68084-645_ef523acc-06b6-4e1c-a58b-4e5fad3407c2 68084-645 HUMAN PRESCRIPTI
68084-647_ed63f206-d8e3-4ea6-ba76-8a4bef93d982 68084-647 HUMAN PRESCRIPTI
68084-649_99930370-0a84-40a5-89ab-d87bbb062e77 68084-649 HUMAN PRESCRIPTI
ON DRUG Pioglitazone pioglitazone TABLET ORAL 20140122
ANDA ANDA078670 American Health Packaging PIOGLITAZONE HYDROCHLORI
DE 15 mg/1 "Peroxisome Proliferator Receptor alpha Agonist [EPC],Pe
roxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activ
ated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemic
al/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient]"
68084-651_fa3fd5a2-bdca-4798-9bf4-26f414be0f77 68084-651 HUMAN PRESCRIPTI
ON DRUG Clarithromycin Clarithromycin TABLET ORAL 20140416
ANDA ANDA065136 American Health Packaging CLARITHROMYCIN 500
mg/1 "Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochro
me P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein
Inhibitors [MoA]"
68084-654_4614480b-b36e-4dbd-9fc0-d083890d297d 68084-654 HUMAN PRESCRIPTI
68084-655_d276da3c-9952-4674-a54d-b1258df71b8a 68084-655 HUMAN PRESCRIPTI
ON DRUG Lithium Carbonate Lithium Carbonate "TABLET, EXTENDE
Health Packaging LITHIUM CARBONATE 450 mg/1 Mood Stabilizer
[EPC]
68084-656_011fa7e7-e135-429e-9e42-75124132555f 68084-656 HUMAN PRESCRIPTI
ON DRUG Azithromycin Dihydrate azithromycin "TABLET, FILM COATED"
g AZITHROMYCIN DIHYDRATE 250 mg/1 "Macrolide Antimicrobial [EPC],M
acrolides [Chemical/Ingredient]"
68084-657_3cf69986-da42-4331-bbbb-5c97326ae3be 68084-657 HUMAN PRESCRIPTI
68084-658_a18c9077-8e71-4fb5-9b1c-34969e59aeb0 68084-658 HUMAN PRESCRIPTI
68084-659_dfe855b6-3517-4bed-92b2-b911517f4673 68084-659 HUMAN PRESCRIPTI
Health Packaging METOPROLOL SUCCINATE 25 mg/1 "Adrenergic beta
68084-663_011fa7e7-e135-429e-9e42-75124132555f 68084-663 HUMAN PRESCRIPTI
g AZITHROMYCIN DIHYDRATE 500 mg/1 "Macrolide Antimicrobial [EPC],M
acrolides [Chemical/Ingredient]"
68084-665_ff6aa7af-399e-4a7d-bbc1-26ad76492cb2 68084-665 HUMAN PRESCRIPTI
ON DRUG Verapamil Verapamil hydrochloride "TABLET, FILM COATED, EX
TENDED RELEASE" ORAL 20140114 ANDA ANDA200878 American
Health Packaging VERAPAMIL HYDROCHLORIDE 120 mg/1 "Calcium Channel
68084-666_dfe855b6-3517-4bed-92b2-b911517f4673 68084-666 HUMAN PRESCRIPTI
Health Packaging METOPROLOL SUCCINATE 50 mg/1 "Adrenergic beta
68084-672_ed63f206-d8e3-4ea6-ba76-8a4bef93d982 68084-672 HUMAN PRESCRIPTI
68084-675_4616f5fa-8e43-4a44-8484-f4dfd950a9b7 68084-675 HUMAN PRESCRIPTI
g DULOXETINE HYDROCHLORIDE 20 mg/1 "Norepinephrine Uptake I
nhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin
Uptake Inhibitors [MoA]"
68084-696_f3614316-c120-4d49-9306-22b42dfbc4fd 68084-696 HUMAN PRESCRIPTI
ON DRUG Nadolol Nadolol TABLET ORAL 20140401 ANDA
ANDA074501 American Health Packaging NADOLOL 20 mg/1 "Adrener
68084-698_e05bdeb4-07a9-441e-901b-f2aea550db2b 68084-698 HUMAN PRESCRIPTI
34 American Health Packaging VENLAFAXINE HYDROCHLORIDE 37.5
68084-699_03c9ff0d-46e8-448c-944a-7ad59d1afd6d 68084-699 HUMAN PRESCRIPTI
Packaging ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 7.5 mg/1; mg
/1 "Full Opioid Agonists [MoA],Opioid Agonist [EPC]"
68084-707_f3614316-c120-4d49-9306-22b42dfbc4fd 68084-707 HUMAN PRESCRIPTI
68084-710_03c9ff0d-46e8-448c-944a-7ad59d1afd6d 68084-710 HUMAN PRESCRIPTI
Packaging ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 10 mg/1; mg/1
"Full Opioid Agonists [MoA],Opioid Agonist [EPC]"
68084-717_3a294ce5-f6a1-46ff-a840-b20973fad9b6 68084-717 HUMAN PRESCRIPTI
ANDA ANDA077824 American Health Packaging RANITIDINE HYDROCHLORIDE
tagonist [EPC]"
68084-721_90ece2f8-9d69-49a6-9c79-7fa628acb31f 68084-721 HUMAN PRESCRIPTI
ANDA ANDA202566 American Health Packaging MODAFINIL 200
68084-722_1ed191f5-7df5-488c-bb72-91ac0b618d9a 68084-722 HUMAN PRESCRIPTI
ON DRUG Moxifloxacin Hydrochloride Moxifloxacin Hydrochloride
American Health Packaging MOXIFLOXACIN HYDROCHLORIDE 400 mg/1
68084-725_bc45263a-21bd-49e8-ad06-0d5f3dc46bfd 68084-725 HUMAN PRESCRIPTI
68084-726_563eff16-a16f-470c-94ca-08877e4d42f7 68084-726 HUMAN PRESCRIPTI
ANDA ANDA077183 American Health Packaging AMLODIPINE BESYLATE; BEN
AZEPRIL HYDROCHLORIDE 10; 20 mg/1; mg/1 "Angiotensin Converting Enzyme I
nhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pr
essure [PE],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Bl
ocker [EPC],Dihydropyridines [Chemical/Ingredient]"
American Health Packaging HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20
68084-729_6a3338b4-5ab2-4eec-8e73-599707abc710 68084-729 HUMAN PRESCRIPTI
GALANTAMINE HYDROBROMIDE 4 mg/1 "Cholinesterase Inhibitor [EPC],
Cholinesterase Inhibitors [MoA]"
68084-734_bc45263a-21bd-49e8-ad06-0d5f3dc46bfd 68084-734 HUMAN PRESCRIPTI
68084-736_1af0c69a-b2cb-4f50-af82-523871bae961 68084-736 HUMAN PRESCRIPTI
68084-737_25e976c7-d3c4-4801-8ef9-5e7ebdcc8257 68084-737 HUMAN PRESCRIPTI
ON DRUG Citalopram Citalopram Hydrobromide "TABLET, FILM COATED"
g CITALOPRAM HYDROBROMIDE 10 mg/1 "Serotonin Reuptake Inhibitor [E
68084-739_b72d60db-7fb8-4b57-94e8-2030f38cee6b 68084-739 HUMAN PRESCRIPTI
Packaging BENAZEPRIL HYDROCHLORIDE 40 mg/1 "Angiotensin Con
68084-743_712965e2-c089-46c3-9a86-d3f61673b25d 68084-743 HUMAN PRESCRIPTI
ON DRUG Doxycycline doxycycline CAPSULE ORAL 20140602
ANDA ANDA065055 American Health Packaging DOXYCYCLINE 100
mg/1
68084-744_25e976c7-d3c4-4801-8ef9-5e7ebdcc8257 68084-744 HUMAN PRESCRIPTI
g CITALOPRAM HYDROBROMIDE 20 mg/1 "Serotonin Reuptake Inhibitor [E
68084-745_fce33b2c-a12a-442d-95ed-c51bde30b3ee 68084-745 HUMAN PRESCRIPTI
ANDA077870 American Health Packaging GLYBURIDE; METFORMIN HYDROCHLORI
DE 5; 500 mg/1; mg/1 "Sulfonylurea [EPC],Sulfonylurea Compounds [Chem
68084-747_65057096-1df9-4cb8-829e-8c8bec006d60 68084-747 HUMAN PRESCRIPTI
American Health Packaging SULFAMETHOXAZOLE; TRIMETHOPRIM 400; 80 mg/1; mg
68084-748_aaa95a2a-4118-4beb-953e-c4d888c91b5f 68084-748 HUMAN PRESCRIPTI
ON DRUG Guanfacine Hydrochloride Guanfacine Hydrochloride
Packaging GUANFACINE HYDROCHLORIDE 1 mg/1 "Adrenergic alph
68084-749_f87902a9-31a9-4ac8-ad86-3aa63987bed8 68084-749 HUMAN PRESCRIPTI
ON DRUG LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE LOSARTAN POTASSI
UM AND HYDROCHLOROTHIAZIDE "TABLET, FILM COATED" ORAL 20140530
ANDA ANDA078385 American Health Packaging HYDROCHLOROTHIAZIDE; LOS
ARTAN POTASSIUM 25; 100 mg/1; mg/1 "Increased Diuresis [PE],Thiazide Diuret
ic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA
],Angiotensin 2 Receptor Blocker [EPC]"
68084-750_ba764ce4-36fe-4aa4-96a4-d0479b875b4f 68084-750 HUMAN PRESCRIPTI
American Health Packaging HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5
68084-753_5f321a03-ccfb-4c11-ac60-a461a5580c69 68084-753 HUMAN PRESCRIPTI
American Health Packaging CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1
68084-755_cbc3e50e-2329-4ec5-a809-439d3d77f27c 68084-755 HUMAN PRESCRIPTI
68084-756_911fb65c-38b4-4160-aedd-44afd23b3d39 68084-756 HUMAN PRESCRIPTI
ON DRUG NIACIN NIACIN "TABLET, EXTENDED RELEASE" ORAL 20140520
ANDA ANDA090860 American Health Packaging NIACIN 500 mg/1
"Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient]"
68084-758_c90b0747-9493-4036-9f6b-e71fe7f38dbf 68084-758 HUMAN PRESCRIPTI
ON DRUG Levocetirizine Dihydrochloride Levocetirizine Dihydrochloride
Packaging LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1 "Histamine H1 Re
68084-762_1d8bbee3-4c95-4e42-b73e-5ad68a3b8e5c 68084-762 HUMAN PRESCRIPTI
68084-763_cbc3e50e-2329-4ec5-a809-439d3d77f27c 68084-763 HUMAN PRESCRIPTI
68084-764_09b3fdc2-38de-4a37-ac9b-d7eabb6db0f9 68084-764 HUMAN PRESCRIPTI
ON DRUG "Dibasic Sodium Phosphate, Monobasic Potassium Phosphate and Monobasic S
odium Phosphate" "Dibasic Sodium Phosphate, Monobasic Potassium P
hosphate and Monobasic Sodium Phosphate" TABLET ORAL 20140602
UNAPPROVED DRUG OTHER American Health Packaging "POTASSIUM PHOSP
HATE, MONOBASIC; SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBAS
IC, MONOHYDRATE" 155; 852; 130 mg/1; mg/1; mg/1
ANDA ANDA077321 American Health Packaging LISINOPRIL 2.5
American Health Packaging HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10
68084-775_ef523acc-06b6-4e1c-a58b-4e5fad3407c2 68084-775 HUMAN PRESCRIPTI
68084-779_f1ccc10a-e42d-44f7-b7da-5538f3b39461 68084-779 HUMAN PRESCRIPTI
ON DRUG cilostazol cilostazol TABLET ORAL 20140730
ANDA ANDA077030 American Health Packaging CILOSTAZOL 50
mg/1 "Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA
]"
68084-784_b8fbc985-62a5-4bc2-b9b8-0451926e86de 68084-784 HUMAN PRESCRIPTI
ON DRUG Clorazepate Dipotassium Clorazepate Dipotassium TABLET ORAL
CLORAZEPATE DIPOTASSIUM 3.75 mg/1 "Benzodiazepine [EPC],Benzodiazepines [C
68084-787_9a19ffd6-2adb-4dbb-b1d0-24b9f3192084 68084-787 HUMAN OTC DRUG
ORGAN-I NR guaifenesin TABLET ORAL 20140731
OTC MONOGRAPH FINAL part341 American Health Packaging GUAIFENESIN
200 mg/1
68084-789_fc29adaa-48f1-40d4-a721-307462f3025a 68084-789 HUMAN PRESCRIPTI
ON DRUG Hydrocortisone hydrocortisone TABLET ORAL 20140616
ANDA ANDA040761 American Health Packaging HYDROCORTISONE 5
68084-796_d40cd079-c5aa-4226-ba0c-4d6de0f00b8e 68084-796 HUMAN PRESCRIPTI
CIII
68084-804_250d1f58-83e8-42d3-a4e2-205a3a5c422e 68084-804 HUMAN PRESCRIPTI
ON DRUG Valsartan valsartan TABLET ORAL 20140721
NDA NDA021283 American Health Packaging VALSARTAN 80
[EPC]"
68084-822_250d1f58-83e8-42d3-a4e2-205a3a5c422e 68084-822 HUMAN PRESCRIPTI
ON DRUG Valsartan valsartan TABLET ORAL 20140721
NDA NDA021283 American Health Packaging VALSARTAN 160
[EPC]"
67361-001_6deb627a-b6bf-42b2-8b1e-7d5996313315 67361-001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS "American Home Health Care, Inc." OXYGEN
210 mL/L
69022-001_d72dfb3d-666b-48c0-a674-b7bf5ea65174 69022-001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS "American Home Medical Equipment and Services, I
nc." OXYGEN 99 L/100L
68762-107_04f5a95a-2315-407f-9579-ff51c88cd2cf 68762-107 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS American Home Medical Equipment Co. LLC OXYGEN
99 L/100L
68515-001_45710f8c-3d88-4154-b790-4b0698cb0013 68515-001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS "American Home Respiratory Care, Inc." OXYGEN
992 mL/L
63076-0001_553b5800-858a-4c05-a5f1-dc88870b7fdd 63076-0001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS "American Homecare Specialists, Inc." OXYGEN
99 L/100L
50183-112_c42571fb-3f0e-4328-92c7-759ff5140b55 50183-112 HUMAN OTC DRUG
go wipes benzalkonium chloride CLOTH TOPICAL 20100701
OTC MONOGRAPH NOT FINAL part352 American Hygiene Industries BENZALKONIUM CHL
ORIDE 3.48 g/34.8g
50519-221_60c9f9c4-032c-45a3-85db-2239d362ccc5 50519-221 HUMAN OTC DRUG
Sani-Gel ALCOHOL GEL TOPICAL 20091201 OTC MONO
GRAPH NOT FINAL part333 "American Industrial Supply, Inc." ALCOHOL 0.7
mL/mL
50519-738_440f158e-0626-428e-9ad5-a49265926364 50519-738 HUMAN OTC DRUG
Sani Spritz ALCOHOL LIQUID TOPICAL 20091231 OTC MONO
GRAPH NOT FINAL part333 "American Industrial Supply, Inc." ALCOHOL 0.7
mL/mL
50519-773_73ed2d6c-2168-47c6-81f4-6b5dc0b75335 50519-773 HUMAN OTC DRUG
Sani Soft ALCOHOL "AEROSOL, FOAM" TOPICAL 20091101
OTC MONOGRAPH NOT FINAL part333 "American Industrial Supply, Inc." ALCOHOL
620 mg/g
76113-012_6123be18-1ee6-46bd-994e-f44b57b4cea4 76113-012 HUMAN OTC DRUG
American Infection Control Antiseptic Hand Wipes Alcohol CLOTH
TOPICAL 20120215 OTC MONOGRAPH NOT FINAL part333E "America
n Infection Control, Inc." ALCOHOL 0.62 mL/mL
76113-012_f7f20fc3-e0d0-4954-ac59-208ea984d55f 76113-012 HUMAN OTC DRUG
American Infection Control Antiseptic Hand Wipes Alcohol CLOTH
76113-112_d2a4d18d-8a38-498f-8cb9-f0bd8a76cd74 76113-112 HUMAN OTC DRUG
American Infection Control Antiseptic Body Wipes Alcohol CLOTH
68419-0001_e5b529a2-46bf-4856-867d-6292b6406c0b 68419-0001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS American Medical Gas LLC OXYGEN 99
L/100L
54384-1072_75313f91-3cdb-4e6b-9e65-fd8f8eaf9338 54384-1072 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS "American Oxygen Company, Inc" OXYGEN 99
L/100L
52164-1101_3ecda643-f738-47fe-b2ce-8b05975d4569 52164-1101 HUMAN OTC DRUG
ARC 42 Essential First Aid Items ISOPROPYL ALCOHOL KIT
20100429 OTC MONOGRAPH FINAL part345 American Red Cross
52164-1102_d116b344-c454-4d0f-ad37-0d88301e7565 52164-1102 HUMAN OTC DRUG
ARC FIRST AID Contains 101 PIECES "BENZALKONIUM CHLORIDE, LIDOCAIN
E, WATER, ISOPROPYL ALCOHOL, ASPIRIN" KIT 20100429
OTC MONOGRAPH FINAL part333 American Red Cross
52164-1103_b45576b9-c77e-4d28-ac35-44d5ee9982d5 52164-1103 HUMAN OTC DRUG
ARC FIRST AID Contains 101 PIECES Hardcase "BENZALKONIUM CHLORIDE,
LIDOCAINE, WATER, ISOPROPYL ALCOHOL, ASPIRIN" KIT 20100428
52164-1104_3bc2e75a-0863-40ce-8f64-7ec7d56aee19 52164-1104 HUMAN OTC DRUG
ARC Emergency Preparedness FIRST AID Contains 202 PIECES "BENZALK
ONIUM CHLORIDE, LIDOCAINE, WATER, ISOPROPYL ALCOHOL, ASPIRIN" KIT
20100427 OTC MONOGRAPH FINAL part333 American Red Cross
52164-1105_11272c2b-c459-4cae-9248-4646a532e736 52164-1105 HUMAN OTC DRUG
E, WATER, ISOPROPYL ALCOHOL,BENZOCAINE,ALCOHOL, ASPIRIN,BACITRACIN ZINC,NEOMYCIN
SULFATE,POLYMYXIN B SULFATE" KIT 20100429 OTC MONO
GRAPH FINAL part333 American Red Cross
52164-1106_badbeb85-1c35-4220-ae61-bf5052b41feb 52164-1106 HUMAN OTC DRUG
ARC FIRST AID Contains 303 PIECES HARDCASE "BENZALKONIUM CHLORIDE,
LIDOCAINE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEBACITRACIN ZINC
, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, WATER, ISOPROPYL ALCOHOL,BENZOCAINE,ALC
OHOL, ASPIRIN" KIT 20100428 OTC MONOGRAPH FINAL
part333 American Red Cross
52164-1107_6abbad39-121a-4516-86f7-44bff245d21b 52164-1107 HUMAN OTC DRUG
E, WATER, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, WATER, ISOPROP
YL ALCOHOL, BENZOCAINE, ALCOHOL, ASPIRIN" KIT 20100427
52164-1108_50656ad8-a6ab-451b-90ff-dcce11587476 52164-1108 HUMAN OTC DRUG
E, WATER, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, WATER, ISOPROP
YL ALCOHOL, BENZOCAINE, ALCOHOL, ASPIRIN" KIT 20100602
52164-1109_1d471d7f-c440-42c0-a013-ed9e2dd902f0 52164-1109 HUMAN OTC DRUG
ARC FIRST AID Emergency Preparedness Contains 167 PIECES "BENZALK
ONIUM CHLORIDE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, WATER, I
SOPROPYL ALCOHOL, BENZOCAINE, ALCOHOL, ASPIRIN," KIT 20100428
52164-1120_1ef38df7-8cb4-4909-9de8-edbb4675fa8d 52164-1120 HUMAN OTC DRUG
The New Parent First Aid "BACITRACIN ZINC,NEOMYCIN SULFATE,POLYMY
XIN B SULFATE, ISOPROPYL ALCOHOL, ALCOHOL" KIT 20100507
0517-0020_bb01c86c-66ad-45d8-9f01-a84fb9b4ff14 0517-0020 HUMAN PRESCRIPTI
ON DRUG Caffeine Citrate Caffeine Citrate "INJECTION, SOLU
TION" INTRAVENOUS 20070910 ANDA ANDA077906 "America
n Regent, Inc." CAFFEINE CITRATE 20 mg/mL "Central Nervous System
Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xan
thines [Chemical/Ingredient]"
0517-0031_05386eaa-75b6-44a2-afb6-4fe04e38e67a 0517-0031 HUMAN PRESCRIPTI
ON DRUG Cyanocobalamin cyanocobalamin "INJECTION, SOLUTION" INTRAMUS
CULAR 19900930 ANDA ANDA080737 "American Regent, Inc."
CYANOCOBALAMIN 1000 ug/mL "Vitamin B 12 [Chemical/Ingredient],Vitamin B12
[EPC]"
[EPC]"
0517-0033_1f217626-9718-467b-8062-00a0064ec150 0517-0033 HUMAN PRESCRIPTI
ON DRUG Neostigmine Methylsulfate Neostigmine Methylsulfate
"INJECTION, SOLUTION" INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20030116
UNAPPROVED DRUG OTHER "American Regent, Inc." NEOSTIGMINE METHYLSULFAT
E 1 mg/mL "Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitor
s [MoA]"
0517-0034_1f217626-9718-467b-8062-00a0064ec150 0517-0034 HUMAN PRESCRIPTI
ON DRUG Neostigmine Methylsulfate Neostigmine Methylsulfate
UNAPPROVED DRUG OTHER "American Regent, Inc." NEOSTIGMINE METHYLSULFAT
E 0.5 mg/mL "Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitor
s [MoA]"
0517-0101_d51a918e-bba6-48ca-8461-76e61324b7e8 0517-0101 HUMAN PRESCRIPTI
ON DRUG Atropine Sulfate Atropine Sulfate "INJECTION, SOLU
TION" INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19921101
UNAPPROVED DRUG OTHER "American Regent, Inc." ATROPINE SULFATE
1 mg/mL "Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic
Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]"
[EPC]"
0517-0131_02298ea1-b461-4bc9-b426-488d059ed3ea 0517-0131 HUMAN PRESCRIPTI
ON DRUG Dexpanthenol Dexpanthenol "INJECTION, SOLUTION" INTRAMUS
CULAR; INTRAVENOUS 19930820 UNAPPROVED DRUG OTHER
"American Regent, Inc." DEXPANTHENOL 250 mg/mL
0517-0132_19b4ee40-b258-4129-a4b9-4cffdadccbd4 0517-0132 HUMAN PRESCRIPTI
ON DRUG Calcitriol Calcitriol "INJECTION, SOLUTION" INTRAVEN
OUS 20050314 ANDA ANDA075746 "American Regent, Inc."
CALCITRIOL 1 ug/mL "Cholecalciferol [Chemical/Ingredient],Vitamin D
3 Analog [EPC]"
0517-0134_af01fdb8-d3d7-4186-a58f-f58839f1ceb8 0517-0134 HUMAN PRESCRIPTI
ON DRUG Dexferrum iron dextran "INJECTION, SOLUTION" INTRAVEN
OUS 19981001 NDA NDA040024 "American Regent, Inc."
acement [EPC]"
0517-0234_af01fdb8-d3d7-4186-a58f-f58839f1ceb8 0517-0234 HUMAN PRESCRIPTI
ON DRUG Dexferrum iron dextran "INJECTION, SOLUTION" INTRAVEN
OUS 19960301 NDA NDA040024 "American Regent, Inc."
acement [EPC]"
0517-0299_6c506d53-fae5-4405-9170-343f6f95f387 0517-0299 HUMAN PRESCRIPTI
UNAPPROVED DRUG OTHER "American Regent, Inc." PHENYLEPHRINE HYDROCHLOR
IDE 10 mg/mL "alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agon
ists [MoA]"
0517-0301_e8ae0b66-25de-41b1-8013-7f414bbb7568 0517-0301 HUMAN PRESCRIPTI
ON DRUG Methylene Blue Methylene Blue "INJECTION, SOLUTION" INTRAVEN
OUS 19900930 UNAPPROVED DRUG OTHER "American Regent
, Inc." METHYLENE BLUE 10 mg/mL
0517-0375_0aade973-199f-44a5-92fd-43afc75dbbdb 0517-0375 HUMAN PRESCRIPTI
ON DRUG Indigo Carmine Indigo Carmine "INJECTION, SOLUTION" INTRAMUS
CULAR; INTRAVENOUS 19900930 UNAPPROVED DRUG OTHER
"American Regent, Inc." INDIGOTINDISULFONATE SODIUM 8 mg/mL
0.4 mg/mL "Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic
0517-0405_6c506d53-fae5-4405-9170-343f6f95f387 0517-0405 HUMAN PRESCRIPTI
UNAPPROVED DRUG OTHER "American Regent, Inc." PHENYLEPHRINE HYDROCHLOR
IDE 10 mg/mL "alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agon
ists [MoA]"
0517-0410_ac576c13-8cb6-4b1d-83fb-05d2c8a439e9 0517-0410 HUMAN PRESCRIPTI
ON DRUG Vasopressin Vasopressin "INJECTION, SOLUTION" INTRAMUS
CULAR; SUBCUTANEOUS 19960815 UNAPPROVED DRUG OTHER
"American Regent, Inc." ARGIPRESSIN 20 [USP'U]/mL
0517-0650_08a40e1f-f305-49fb-a702-43438323701a 0517-0650 HUMAN PRESCRIPTI
ON DRUG Injectafer Ferric Carboxymaltose Injection "INJECTION, SOLU
TION" INTRAVENOUS 20130812 NDA NDA203565 "America
n Regent, Inc." FERRIC CARBOXYMALTOSE 50 mg/mL "Iron [Chemical/Ingredie
nt],Parenteral Iron Replacement [EPC]"
0517-0720_0aa6766d-322e-4a61-a04a-257932f50702 0517-0720 HUMAN PRESCRIPTI
ON DRUG Betamethasone Sodium Phosphate and Betamethasone Acetate
Betamethasone Sodium Phosphate and Betamethasone Acetate "INJECTION, SUSP
ENSION" INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR 20100428
ANDA ANDA090747 "American Regent, Inc." BETAMETHASONE ACETATE; BETAMETHA
SONE SODIUM PHOSPHATE 3; 3 mg/mL; mg/mL "Corticosteroid [EPC],Corticoste
roid Hormone Receptor Agonists [MoA],Corticosteroid [EPC],Corticosteroid Hormone
Receptor Agonists [MoA]"
0517-0725_2cb6acc4-4f84-4433-bfd1-2ffe35faf3e9 0517-0725 HUMAN PRESCRIPTI
ON DRUG Buprenorphine Hydrochloride Buprenorphine Hydrochloride
"INJECTION, SOLUTION" INTRAMUSCULAR; INTRAVENOUS 20100813
ANDA ANDA078331 "American Regent, Inc." BUPRENORPHINE HYDROCHLORIDE
0.324 mg/mL "Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA]"
CIII
0517-0730_bfd2cc3b-73dd-402f-acc6-c4816c00b7e8 0517-0730 HUMAN PRESCRIPTI
ON DRUG Clonidine Hydrochloride Clonidine Hydrochloride "INJECTION, SOLU
TION" EPIDURAL 20100415 ANDA ANDA091104 "America
n Regent, Inc." CLONIDINE HYDROCHLORIDE 100 ug/mL "Adrenergic alpha2-Agoni
sts [MoA],Central alpha-2 Adrenergic Agonist [EPC]"
0517-0731_bfd2cc3b-73dd-402f-acc6-c4816c00b7e8 0517-0731 HUMAN PRESCRIPTI
ON DRUG Clonidine Hydrochloride Clonidine Hydrochloride "INJECTION, SOLU
TION" EPIDURAL 20100415 ANDA ANDA091104 "America
n Regent, Inc." CLONIDINE HYDROCHLORIDE 500 ug/mL "Adrenergic alpha2-Agoni
0517-0735_d0577bd6-da57-48de-895a-6af39f31dc7d 0517-0735 HUMAN PRESCRIPTI
ON DRUG Nicardipine Hydrochloride Nicardipine Hydrochloride
"INJECTION, SOLUTION" INTRAVENOUS 20091117 ANDA ANDA0905
34 "American Regent, Inc." NICARDIPINE HYDROCHLORIDE 2.5 mg/mL
"Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC]
,Dihydropyridines [Chemical/Ingredient]"
0517-0740_08d60c14-0e2b-4fa7-81d5-75f4320704d6 0517-0740 HUMAN PRESCRIPTI
ON DRUG Methylergonovine Maleate Methylergonovine Maleate
ANDA ANDA090193 "American Regent, Inc." METHYLERGONOVINE MALEATE
0.2 mg/mL "Ergolines [Chemical/Ingredient],Ergot Derivative [EPC]"
0517-0745_02bdc4b0-18cb-4806-a381-f3324eac8f86 0517-0745 HUMAN PRESCRIPTI
ON DRUG Pamidronate Disodium Pamidronate Disodium "INJECTION, SOLU
n Regent, Inc." PAMIDRONATE DISODIUM 3 mg/mL "Bisphosphonate [EPC],Di
phosphonates [Chemical/Ingredient]"
0517-0746_02bdc4b0-18cb-4806-a381-f3324eac8f86 0517-0746 HUMAN PRESCRIPTI
ON DRUG Pamidronate Disodium Pamidronate Disodium "INJECTION, SOLU
n Regent, Inc." PAMIDRONATE DISODIUM 9 mg/mL "Bisphosphonate [EPC],Di
phosphonates [Chemical/Ingredient]"
0517-0750_67cbd1da-38b6-498e-a721-6fb2f4528a68 0517-0750 HUMAN PRESCRIPTI
ON DRUG Progesterone Progesterone "INJECTION, SOLUTION" INTRAMUS
PROGESTERONE 50 mg/mL "Progesterone [Chemical/Ingredient],Progesterone
[EPC]"
0517-0760_e4abdf47-d651-478c-be0b-88b2f256023c 0517-0760 HUMAN PRESCRIPTI
20100701 ANDA ANDA076830 "American Regent, Inc." OFLOXACI
N 3 mg/mL "Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingr
edient]"
0517-0770_a6fcba37-f7d9-4d9e-bf45-c8f7af4261e3 0517-0770 HUMAN PRESCRIPTI
ON DRUG Torsemide Torsemide "INJECTION, SOLUTION" INTRAVEN
TORSEMIDE 10 mg/mL "Increased Diuresis at Loop of Henle [PE],Loop D
iuretic [EPC]"
0517-0771_a6fcba37-f7d9-4d9e-bf45-c8f7af4261e3 0517-0771 HUMAN PRESCRIPTI
ON DRUG Torsemide Torsemide "INJECTION, SOLUTION" INTRAVEN
TORSEMIDE 10 mg/mL "Increased Diuresis at Loop of Henle [PE],Loop D
iuretic [EPC]"
0517-0780_1bc50999-f23f-4d64-be7f-7ca5423e720c 0517-0780 HUMAN PRESCRIPTI
ON DRUG Etomidate Etomidate "INJECTION, SOLUTION" INTRAVEN
ETOMIDATE 2 mg/mL "General Anesthesia [PE],General Anesthetic [EPC
]"
0517-0781_1bc50999-f23f-4d64-be7f-7ca5423e720c 0517-0781 HUMAN PRESCRIPTI
ON DRUG Etomidate Etomidate "INJECTION, SOLUTION" INTRAVEN
ETOMIDATE 2 mg/mL "General Anesthesia [PE],General Anesthetic [EPC
]"
0517-0785_38afd657-1aed-43d6-aad3-9e75fc025e57 0517-0785 HUMAN PRESCRIPTI
ON DRUG Benztropine Mesylate Benztropine Mesylate "INJECTION, SOLU
TION" INTRAMUSCULAR; INTRAVENOUS 20110204 ANDA ANDA0911
52 "American Regent, Inc." BENZTROPINE MESYLATE 1 mg/mL "Anticho
linergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Recep
tor Antagonists [MoA]"
0517-0790_a5bf7ff6-bba0-4e86-92d1-9f929fd4794b 0517-0790 HUMAN PRESCRIPTI
ON DRUG Nandrolone Decanoate Nandrolone Decanoate "INJECTION, SOLU
TION" INTRAMUSCULAR 20000101 ANDA ANDA091252 "America
n Regent, Inc." NANDROLONE DECANOATE 200 mg/mL Androgen [EPC] CIII
0.4 mg/.5mL "Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic
0517-0830_d9744bf1-5b9f-40fe-a23e-e74ab4e0297c 0517-0830 HUMAN PRESCRIPTI
ON DRUG Latanoprost Latanoprost SOLUTION OPHTHALMIC
20110802 ANDA ANDA200925 "American Regent, Inc." LATANOPR
OST 50 ug/mL "Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ing
redient]"
0517-0901_2e4ecf15-03d9-4e8c-9826-e5392cea3e10 0517-0901 HUMAN PRESCRIPTI
ANDA ANDA040136 "American Regent, Inc." HYDRALAZINE HYDROCHLORIDE
20 mg/mL "Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]"
0517-0955_583f95c1-4f98-44d7-bb7f-2db827176478 0517-0955 HUMAN PRESCRIPTI
ON DRUG Olanzapine Olanzapine "INJECTION, POWDER, LYOPHILIZED,
FOR SOLUTION" INTRAMUSCULAR 20120627 ANDA ANDA201741
"American Regent, Inc." OLANZAPINE 10 mg/2mL Atypical Antipsychotic [
EPC]
0517-0960_3940ffa8-61ff-47cf-91da-2d5afee99fe0 0517-0960 HUMAN PRESCRIPTI
TRANEXAMIC ACID 100 mg/mL "Antifibrinolytic Agent [EPC],Decreased Fibrinol
ysis [PE]"
1 mg/mL "Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic
0517-1045_ed6256cb-00cd-4d85-9d7a-25de3282544f 0517-1045 HUMAN PRESCRIPTI
ON DRUG Levocarnitine Levocarnitine "INJECTION, SOLUTION" INTRAVEN
LEVOCARNITINE 200 mg/mL "Carnitine [Chemical/Ingredient],Carnitine Analo
g [EPC]"
0517-1071_68b1bf4a-ca90-47f6-99b8-939e75f14601 0517-1071 HUMAN PRESCRIPTI
ON DRUG Epinephrine Epinephrine "INJECTION, SOLUTION" INTRACAR
DIAC; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19900930 UNAPPROV
ED DRUG OTHER "American Regent, Inc." EPINEPHRINE 1 mg/mL
"Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic
Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines
0517-1130_9c0aad7a-46d5-4185-bfbd-ec11897d4bd8 0517-1130 HUMAN PRESCRIPTI
ON DRUG Epinephrine Epinephrine "INJECTION, SOLUTION" INTRAMUS
CULAR; INTRAVENOUS; SUBCUTANEOUS 19940301 UNAPPROVED DRUG
OTHER "American Regent, Inc." EPINEPHRINE 1 mg/mL "Adrener
gic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist
[EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemica
l/Ingredient]"
0517-1305_65363aba-6fcc-4710-a54b-a4a75b4060d3 0517-1305 HUMAN PRESCRIPTI
ON DRUG Dopamine HCl Dopamine HCl "INJECTION, SOLUTION" INTRAVEN
DOPAMINE HYDROCHLORIDE 160 mg/mL "Catecholamine [EPC],Catecholamines [Che
mical/Ingredient]"
0517-1355_8f6bd808-342f-404b-8943-6483641fe1d3 0517-1355 HUMAN PRESCRIPTI
ON DRUG Metoprolol Tartrate Metoprolol Tartrate "INJECTION, SOLU
n Regent, Inc." METOPROLOL TARTRATE 1 mg/mL "Adrenergic beta-Antagon
mical/Ingredient]"
mical/Ingredient]"
0517-2050_1923c5a9-ac44-43f3-9927-047f440ad6f4 0517-2050 HUMAN PRESCRIPTI
ON DRUG L-Cysteine Hydrochloride L-Cysteine Hydrochloride
"INJECTION, SOLUTION" INTRAVENOUS 20000101 UNAPPROVED DRUG
OTHER "American Regent, Inc." CYSTEINE HYDROCHLORIDE 50 mg/mL
0517-2053_85db0573-7200-41ba-9108-ba632c71dcca 0517-2053 HUMAN PRESCRIPTI
ON DRUG Potassium Acetate Potassium Acetate "INJECTION, SOLU
TION" INTRAVENOUS 19900930 UNAPPROVED DRUG OTHER
"American Regent, Inc." POTASSIUM ACETATE 196 mg/mL "Potassium Compo
0517-2064_1923c5a9-ac44-43f3-9927-047f440ad6f4 0517-2064 HUMAN PRESCRIPTI
ON DRUG L-Cysteine Hydrochloride L-Cysteine Hydrochloride
OTHER "American Regent, Inc." CYSTEINE HYDROCHLORIDE 50 mg/mL
0517-2096_6a5da55b-3199-4b98-a2a4-5efca91b3c91 0517-2096 HUMAN PRESCRIPTI
ON DRUG Sodium Acetate Sodium Acetate "INJECTION, SOLUTION, CONCENTRAT
E" INTRAVENOUS 19900930 UNAPPROVED DRUG OTHER
"American Regent, Inc." SODIUM ACETATE ANHYDROUS 164 mg/mL
0517-2305_c95adfb7-d385-4504-8353-6983517e5513 0517-2305 HUMAN PRESCRIPTI
ON DRUG potassium phosphates "Potassium Phosphate, Monobasic and Pota
ssium Phosphate, Dibasic" "INJECTION, SOLUTION" INTRAVENOUS 19891119
UNAPPROVED DRUG OTHER "American Regent, Inc." "POTASSIUM PHOSPHATE, DI
BASIC; POTASSIUM PHOSPHATE, MONOBASIC" 236; 224 mg/mL; mg/mL
0517-2310_c5a93448-024c-4920-8226-9ddf746e30e7 0517-2310 HUMAN PRESCRIPTI
ON DRUG Venofer iron sucrose "INJECTION, SOLUTION" INTRAVENOUS
20070612 NDA NDA021135 "American Regent, Inc." IRON SUC
ROSE 20 mg/mL "Iron [Chemical/Ingredient],Parenteral Iron Replacement
[EPC]"
[EPC]"
[EPC]"
0517-2502_cc74fb4c-d783-43a8-8151-925d9a40524b 0517-2502 HUMAN PRESCRIPTI
ON DRUG Caffeine and Sodium Benzoate Caffeine and Sodium Benzoate
UNAPPROVED DRUG OTHER "American Regent, Inc." CAFFEINE 125
mg/mL "Central Nervous System Stimulant [EPC],Central Nervous System Stimulati
on [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient]"
0517-2602_274e5d29-4332-4d4d-b78f-bd4361c5cb61 0517-2602 HUMAN PRESCRIPTI
ON DRUG Magnesium Sulfate Magnesium Sulfate "INJECTION, SOLU
OTHER "American Regent, Inc." MAGNESIUM SULFATE HEPTAHYDRATE 500
mg/mL "Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA]"
0517-2710_35f0f3e5-deee-4f3d-996e-92a303d229f1 0517-2710 HUMAN PRESCRIPTI
ON DRUG Calcium Chloride Calcium Chloride "INJECTION, SOLU
"American Regent, Inc." CALCIUM CHLORIDE 100 mg/mL "Calcium [Chemic
al/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity
[MoA]"
0517-2810_0859ec99-9f2f-4523-9c03-2655e8517abd 0517-2810 HUMAN PRESCRIPTI
ON DRUG Sodium Chloride Sodium Chloride "INJECTION, SOLUTION" INTRAVEN
, Inc." SODIUM CHLORIDE 9 mg/mL
0517-3005_aec4d54b-56b2-4964-b5dd-c81db1385b70 0517-3005 HUMAN PRESCRIPTI
ON DRUG Sterile Water Water "INJECTION, SOLUTION" INTRAVENOUS
19900930 UNAPPROVED DRUG OTHER "American Regent, Inc."
WATER 1 mL/mL
WATER 1 mL/mL
WATER 1 mL/mL
0517-3405_29820a34-5673-4df4-9877-1657d3279f52 0517-3405 HUMAN PRESCRIPTI
ON DRUG Sodium Phosphates "sodium phosphate, monobasic, monohydrat
e and sodium phosphate, dibasic anhydrous" "INJECTION, SOLUTION" INTRAVEN
, Inc." "SODIUM PHOSPHATE, DIBASIC ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOH
YDRATE" 142; 276 mg/mL; mg/mL
0517-3605_a48d448d-544c-4837-9103-ab183412ad89 0517-3605 HUMAN PRESCRIPTI
ON DRUG Levetiracetam Levetiracetam "INJECTION, SOLUTION" INTRAVEN
LEVETIRACETAM 100 mg/mL "Anti-epileptic Agent [EPC],Decreased Central Ne
0517-3900_5178d569-7ff6-46de-a8ce-498e9608ef3f 0517-3900 HUMAN PRESCRIPTI
ON DRUG Calcium Gluconate Calcium Gluconate "INJECTION, SOLU
"American Regent, Inc." CALCIUM GLUCONATE MONOHYDRATE 98 mg/mL "Calcium
[Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating
Activity [MoA]"
0517-3950_5178d569-7ff6-46de-a8ce-498e9608ef3f 0517-3950 HUMAN PRESCRIPTI
ON DRUG Calcium Gluconate Calcium Gluconate "INJECTION, SOLU
"American Regent, Inc." CALCIUM GLUCONATE MONOHYDRATE 98 mg/mL "Calcium
[Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating
Activity [MoA]"
0517-4002_5ee8d0b3-841f-45a7-a363-76363ad481c1 0517-4002 HUMAN PRESCRIPTI
ON DRUG Papaverine Hydrochloride Papaverine Hydrochloride
OTHER "American Regent, Inc." PAPAVERINE HYDROCHLORIDE 30
mg/mL
0517-4010_5ee8d0b3-841f-45a7-a363-76363ad481c1 0517-4010 HUMAN PRESCRIPTI
ON DRUG Papaverine Hydrochloride Papaverine Hydrochloride
OTHER "American Regent, Inc." PAPAVERINE HYDROCHLORIDE 30
mg/mL
0517-4050_560eaf50-0d23-4df6-9068-eebba66634d4 0517-4050 HUMAN PRESCRIPTI
ON DRUG Mannitol mannitol "INJECTION, SOLUTION" INTRAVEN
MANNITOL 250 mg/mL "Increased Diuresis [PE],Osmotic Activity [MoA],
Osmotic Diuretic [EPC]"
0517-4201_7556bff3-b6b4-414b-8ae0-40e2cc63b39e 0517-4201 HUMAN PRESCRIPTI
"INJECTION, SOLUTION" INTRAMUSCULAR 19900930 ANDA ANDA0874
08 "American Regent, Inc." HYDROXYZINE HYDROCHLORIDE 25 mg/mL
0517-4601_6dd20e3a-5119-4003-a3ca-60d843914630 0517-4601 HUMAN PRESCRIPTI
ON DRUG Glycopyrrolate Glycopyrrolate "INJECTION, SOLUTION" INTRAMUS
CULAR; INTRAVENOUS 19900930 ANDA ANDA089335 "America
n Regent, Inc." GLYCOPYRROLATE 0.2 mg/mL "Anticholinergic [EPC],Cholinerg
ic Antagonists [MoA]"
0517-4810_f7f1a9e4-9103-4a84-9f31-cfbd5eeb33cb 0517-4810 HUMAN PRESCRIPTI
ON DRUG Nitroglycerin nitroglycerin "INJECTION, SOLUTION" INTRAVEN
NITROGLYCERIN 5 mg/mL "Nitrate Vasodilator [EPC],Nitrates [Chemical/In
0517-4901_e4b6c252-64be-4e4a-88ba-3491d8fd7b3d 0517-4901 HUMAN PRESCRIPTI
ON DRUG Dexamethasone Sodium Phosphate Dexamethasone Sodium Phosphate
"INJECTION, SOLUTION" INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENO
US; SOFT TISSUE 19900930 ANDA ANDA087440 "American Regent
, Inc." DEXAMETHASONE PHOSPHATE 4 mg/mL "Corticosteroid [EPC],Corticoste
0517-5024_0f5c61fb-cf82-4332-a751-1c71f0ab8fb5 0517-5024 HUMAN PRESCRIPTI
ON DRUG Potassium Acetate Potassium Acetate "INJECTION, SOLU
TION, CONCENTRATE" INTRAVENOUS 19900930 UNAPPROVED DRUG
OTHER "American Regent, Inc." POTASSIUM ACETATE 392 mg/mL
0517-5034_60f78290-bd1a-4931-8d99-d9417faacc38 0517-5034 HUMAN PRESCRIPTI
ON DRUG Magnesium Chloride Magnesium Chloride "INJECTION, SOLU
"American Regent, Inc." MAGNESIUM CHLORIDE 200 mg/mL
0517-5702_ef10f6be-4f9f-4d6d-aa84-f60d2f3d42b9 0517-5702 HUMAN PRESCRIPTI
ON DRUG Furosemide Furosemide INJECTION INTRAVENOUS
19900930 NDA NDA018579 "American Regent, Inc." FUROSEMI
DE 10 mg/mL "Increased Diuresis at Loop of Henle [PE],Loop Diuretic
[EPC]"
[EPC]"
[EPC]"
0517-6110_aa7dac70-f497-4191-b52a-a96cf25872a8 0517-6110 HUMAN PRESCRIPTI
ON DRUG Zinc Sulfate Zinc Sulfate "INJECTION, SOLUTION" INTRAVEN
, Inc." ZINC SULFATE ANHYDROUS 1 mg/mL "Copper Absorption Inhibitor [EP
C],Decreased Copper Ion Absorption [PE]"
0517-6202_c8aa6a43-0e1f-43e5-a042-e3b3a3e931dd 0517-6202 HUMAN PRESCRIPTI
ON DRUG Multitrace-4 Neonatal Trace Elements 4 "INJECTION, SOLU
"American Regent, Inc." CHROMIC CHLORIDE; CUPRIC SULFATE; MANGANESE SULFATE; ZIN
C SULFATE HEPTAHYDRATE 4.36; .39; 77; 6.6 ug/mL; mg/mL; mg/mL; mg/mL
"Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE],Magnetic
Resonance Contrast Activity [MoA],Paramagnetic Contrast Agent [EPC]"
0517-6210_dab399d9-723e-4ef6-8ba7-c41ce2c1b48d 0517-6210 HUMAN PRESCRIPTI
ON DRUG Cupric Sulfate Cupric Sulfate "INJECTION, SOLUTION" INTRAVEN
, Inc." CUPRIC SULFATE 1.57 mg/mL "Copper [Chemical/Ingredient],Copper-con
taining Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decrease
d Sperm Motility [PE],Inhibit Ovum Fertilization [PE]"
0517-6310_b91ec5d3-06e4-46aa-81c1-5e44d99181b9 0517-6310 HUMAN PRESCRIPTI
ON DRUG Chromic Chloride Chromic Chloride "INJECTION, SOLU
"American Regent, Inc." CHROMIC CHLORIDE 20.5 ug/mL "Standardized Ch
emical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [P
E],Allergens [Chemical/Ingredient]"
0517-6410_6b7f76e6-fac4-4690-8fc1-f508e31adc86 0517-6410 HUMAN PRESCRIPTI
ON DRUG Manganese Sulfate Manganese Sulfate "INJECTION, SOLU
"American Regent, Inc." MANGANESE SULFATE 0.308 mg/mL "Magnetic Resona
nce Contrast Activity [MoA],Paramagnetic Contrast Agent [EPC]"
0517-6510_b141a180-0ec0-43e9-a35e-80b87647f5a6 0517-6510 HUMAN PRESCRIPTI
ON DRUG Selenium Selenium "INJECTION, SOLUTION" INTRAVEN
, Inc." SELENIOUS ACID 65.4 ug/mL
0517-6610_18d83044-4b09-45be-a6c4-00f4e6d3d3fb 0517-6610 HUMAN PRESCRIPTI
ON DRUG Ammonium Molybdate Ammonium Molybdate "INJECTION, SOLU
"American Regent, Inc." AMMONIUM MOLYBDATE 46 ug/mL
0517-6902_d82490f5-9a5f-42ae-a1a9-810f867bcf3b 0517-6902 HUMAN PRESCRIPTI
ON DRUG fosphenytoin sodium fosphenytoin sodium "INJECTION, SOLU
99 "American Regent, Inc." FOSPHENYTOIN SODIUM 50 mg/mL "Anti-ep
ivity [PE]"
0517-7201_1363db61-0998-419e-b305-a6a26538c2f8 0517-7201 HUMAN PRESCRIPTI
ON DRUG Multitrace -4 Trace Elements 4 "INJECTION, SOLUTION, CO
NCENTRATE" INTRAVENOUS 19931207 UNAPPROVED DRUG OTHER
C SULFATE HEPTAHYDRATE 51.3; 3.93; 1.54; 22 ug/mL; mg/mL; mg/mL; mg/mL
0517-7210_1363db61-0998-419e-b305-a6a26538c2f8 0517-7210 HUMAN PRESCRIPTI
ON DRUG Multitrace -4 Trace Elements 4 "INJECTION, SOLUTION, CO
C SULFATE HEPTAHYDRATE 51.3; 3.93; 1.54; 22 ug/mL; mg/mL; mg/mL; mg/mL
0517-7410_6817d524-2100-4c8e-91c2-d1d2d999f31a 0517-7410 HUMAN PRESCRIPTI
ON DRUG Multitrace-4 Trace Elements 4 "INJECTION, SOLUTION"
INTRAVENOUS 19940217 UNAPPROVED DRUG OTHER "America
n Regent, Inc." CHROMIC CHLORIDE; CUPRIC SULFATE; MANGANESE SULFATE; ZINC SULFAT
E HEPTAHYDRATE 20.5; 1.57; .308; 4.39 ug/mL; mg/mL; mg/mL; mg/mL "Copper
Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE],Magnetic Resonan
ce Contrast Activity [MoA],Paramagnetic Contrast Agent [EPC]"
0517-7504_2fdbe3e6-e9ee-4f6f-b2f8-391bf741bc5f 0517-7504 HUMAN PRESCRIPTI
ON DRUG Acetylcysteine acetylcysteine INHALANT RESPIRATORY (INH
ALATION) 19951001 ANDA ANDA072489 "American Regent
, Inc." ACETYLCYSTEINE 100 mg/mL "Antidote [EPC],Antidote for Acetaminoph
en Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Gluta
thione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA]"
0517-8105_366c9858-7cda-46f9-83a3-e2dafb00a05c 0517-8105 HUMAN PRESCRIPTI
ON DRUG Zinc Sulfate Zinc Sulfate "INJECTION, SOLUTION" INTRAVEN
, Inc." ZINC SULFATE ANHYDROUS 12.32 mg/mL
0517-8201_dc0753e4-a17a-4020-bba8-8e78a40e031b 0517-8201 HUMAN PRESCRIPTI
ON DRUG Multitrace-5 Trace Elements 5 "INJECTION, SOLUTION, CO
"American Regent, Inc." CHROMIC CHLORIDE; CUPRIC SULFATE; MANGANESE SULFATE; SEL
ENIOUS ACID; ZINC SULFATE HEPTAHYDRATE 51.3; 3.93; 1.54; 98; 22 ug/mL; m
g/mL; mg/mL; ug/mL; mg/mL "Copper Absorption Inhibitor [EPC],Decreased Cop
per Ion Absorption [PE],Magnetic Resonance Contrast Activity [MoA],Paramagnetic
Contrast Agent [EPC]"
0517-8210_dc0753e4-a17a-4020-bba8-8e78a40e031b 0517-8210 HUMAN PRESCRIPTI
ON DRUG Multitrace-5 Trace Elements 5 "INJECTION, SOLUTION, CO
"American Regent, Inc." CHROMIC CHLORIDE; CUPRIC SULFATE; MANGANESE SULFATE; SEL
ENIOUS ACID; ZINC SULFATE HEPTAHYDRATE 51.3; 3.93; 1.54; 98; 22 ug/mL; m
g/mL; mg/mL; ug/mL; mg/mL "Copper Absorption Inhibitor [EPC],Decreased Cop
per Ion Absorption [PE],Magnetic Resonance Contrast Activity [MoA],Paramagnetic
Contrast Agent [EPC]"
0517-8510_9a7f5368-6696-4835-83da-b2358179720c 0517-8510 HUMAN PRESCRIPTI
ON DRUG Multitrace-5 Trace Elements 5 "INJECTION, SOLUTION"
INTRAVENOUS 19940217 UNAPPROVED DRUG OTHER "America
n Regent, Inc." CHROMIC CHLORIDE; CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS A
CID; ZINC SULFATE HEPTAHYDRATE 20.5; 1.57; .308; 32.7; 4.39 ug/mL; mg/mL; mg
/mL; ug/mL; mg/mL "Copper Absorption Inhibitor [EPC],Decreased Copper Ion
Absorption [PE],Magnetic Resonance Contrast Activity [MoA],Paramagnetic Contrast
Agent [EPC]"
0517-8571_75cdf916-e28d-44db-8204-0aa4f23701b8 0517-8571 HUMAN PRESCRIPTI
ON DRUG Dehydrated Alcohol Dehydrated Alcohol "INJECTION, SOLU
TION" INTRASPINAL 19900930 UNAPPROVED DRUG OTHER
"American Regent, Inc." ALCOHOL 0.98 mL/mL
0517-8575_75cdf916-e28d-44db-8204-0aa4f23701b8 0517-8575 HUMAN PRESCRIPTI
ON DRUG Dehydrated Alcohol Dehydrated Alcohol "INJECTION, SOLU
TION" INTRASPINAL 19900930 UNAPPROVED DRUG OTHER
"American Regent, Inc." ALCOHOL 0.98 mL/mL
0517-8880_72f1cd57-ffa9-4814-8403-de4d69dd86d7 0517-8880 HUMAN PRESCRIPTI
ON DRUG Sprix ketorolac tromethamine "SPRAY, METERED" NASAL
20110426 NDA NDA022382 "American Regent, Inc." KETOROLA
C TROMETHAMINE 15.75 mg/1 "Cyclooxygenase Inhibitors [MoA],Nonsteroidal An
rug [EPC]"
0517-8905_2627d4f7-5db1-49e0-bf19-0027ab27197b 0517-8905 HUMAN PRESCRIPTI
ON DRUG Methyldopate Hydrochloride Methyldopate Hydrochloride
79 "American Regent, Inc." METHYLDOPATE HYDROCHLORIDE 50 mg/mL
"Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]"
0517-9120_a34e920d-92fc-4a62-9a35-fb19b35a116f 0517-9120 HUMAN PRESCRIPTI
ON DRUG Aminocaproic Acid Aminocaproic Acid "INJECTION, SOLU
n Regent, Inc." AMINOCAPROIC ACID 250 mg/mL "Antifibrinolytic Agent
[EPC],Decreased Fibrinolysis [PE]"
0517-9203_bf116d1d-8143-4ba5-a987-4dbfd2a695de 0517-9203 HUMAN PRESCRIPTI
ON DRUG Multitrace -4 Pediatric Trace Elements 4 "INJECTION, SOLU
OTHER "American Regent, Inc." CHROMIC CHLORIDE; CUPRIC SULFATE; MANGAN
ESE SULFATE; ZINC SULFATE HEPTAHYDRATE 5.12; .4; 77; 4.39 ug/mL; mg/mL; ug
/mL; mg/mL "Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorpti
on [PE],Magnetic Resonance Contrast Activity [MoA],Paramagnetic Contrast Agent [
EPC]"
0517-9310_0f5d052e-392d-4538-b2ff-c802bff561d2 0517-9310 HUMAN PRESCRIPTI
ON DRUG Trace Elements 4 Trace Elements 4 "INJECTION, SOLU
C SULFATE HEPTAHYDRATE 5.12; .4; 92.3; 2.2 ug/mL; mg/mL; ug/mL; mg/mL
0517-9702_b135de7c-8def-431a-a5cc-1c1d98cc6161 0517-9702 HUMAN PRESCRIPTI
ON DRUG Droperidol Droperidol "INJECTION, SOLUTION" INTRAMUS
n Regent, Inc." DROPERIDOL 2.5 mg/mL "Dopamine D2 Antagonists [MoA],D
opamine-2 Receptor Antagonist [EPC]"
41520-003_6f8ffe57-59ea-4f6b-aceb-432e9fb8a62c 41520-003 HUMAN OTC DRUG
Creamy Petroleum White petrolatum JELLY TOPICAL 20090129
OTC MONOGRAPH FINAL part347 American Sales PETROLATUM 0.3 mg/100g
41520-111_15eda702-b8ea-4d81-a08c-7ad548aa20dd 41520-111 HUMAN OTC DRUG
Care One Maximum Strength Fluoride "PASTE, DENTIFRICE"
DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 American Sales
POTASSIUM NITRATE; SODIUM FLUORIDE 5; .24 g/100g; g/100g
41520-172_897f99da-7773-4931-ab00-433de4d9fd25 41520-172 HUMAN OTC DRUG
ANTIBACTERIAL FOAMING HAND SP LEMONGRASS TRICLOSAN LIQUID
TOPICAL 20110524 OTC MONOGRAPH NOT FINAL part333E AMERICAN
SALES TRICLOSAN 0.6 mL/100mL
41520-183_29223c42-bc35-4633-a212-d53d773dfa02 41520-183 HUMAN OTC DRUG
ANTIBACTERIAL FOAMING HAND SP CHERRY AND ALMOND TRICLOSAN LIQUID
SALES TRICLOSAN 0.6 mL/100mL
41520-226_88584132-b3e6-4e14-a1ca-0a3fc4cd0fa9 41520-226 HUMAN OTC DRUG
Creamy Diaper Rash Zinc Oxide OINTMENT TOPICAL 20110901
OTC MONOGRAPH FINAL part347 American Sales ZINC OXIDE 13 kg/100kg
41520-235_a4035454-bf60-471d-b580-68071fc3bb5c 41520-235 HUMAN OTC DRUG
SANITIZER HAND SANITIZER ETHYL ALCOHOL LIQUID TOPICAL 20110506
OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES ALCOHOL 62 mL/100mL
41520-343_d7d1e9e7-2bcc-4e74-9007-80d9fb3adee2 41520-343 HUMAN OTC DRUG
COTTONTAILS DIAPER RASH ZINC OXIDE OINTMENT TOPICAL 20120501
OTC MONOGRAPH FINAL part347 AMERICAN SALES ZINC OXIDE 0.4 g/g
41520-415_a4bf4237-b53b-41e9-b8d3-2e53360f05d7 41520-415 HUMAN OTC DRUG
41520-582_25d531a1-fda9-4c3c-9db2-b4740675536e 41520-582 HUMAN OTC DRUG
41520-619_b3600254-6acf-4c02-a333-50d6401f4419 41520-619 HUMAN OTC DRUG
Daily Moisturizing Dimethicone LOTION TOPICAL 20120915
OTC MONOGRAPH FINAL part347 American Sales Co DIMETHICONE 1.3
kg/100mL
41520-909_a9b245d4-8bfb-4dbc-a058-f7b40a2dd4d7 41520-909 HUMAN OTC DRUG
Complete Beauty "Octinoxate, Zinc Oxide" LOTION TOPICAL 20100113
OTC MONOGRAPH NOT FINAL part352 American Sales Co OCTINOXATE; ZINC OXIDE
61.2; 30.6 mg/mL; mg/mL
41520-001_4d3bced1-2a59-4fa8-9105-3a59a23baa9d 41520-001 HUMAN OTC DRUG
Vitamin A D "Lanolin, Petrolatum" OINTMENT TOPICAL 20090803
OTC MONOGRAPH FINAL part347 American Sales Company LANOLIN; PETROLATUM
133; 459 mg/g; mg/g
41520-002_9ebb7596-ac6e-4377-af6e-738f656f9131 41520-002 HUMAN OTC DRUG
care one enema Saline ENEMA RECTAL 20100118 OTC MONO
GRAPH NOT FINAL part334 American Sales Company "SODIUM PHOSPHATE, DIBASIC; SODI
UM PHOSPHATE, MONOBASIC" 7; 19 g/118mL; g/118mL
41520-005_2c5c333d-e378-47ab-a24e-d0e119c99599 41520-005 HUMAN OTC DRUG
Saline Laxative sodium phosphate ENEMA RECTAL 20120831
OTC MONOGRAPH NOT FINAL part334 American Sales Company "SODIUM PHOSPHATE, DIBAS
IC; SODIUM PHOSPHATE, MONOBASIC" 7; 19 g/118mL; g/118mL
41520-008_63bc97a1-ff59-4aa0-bae5-f4cc6d4f544b 41520-008 HUMAN OTC DRUG
care one pain relief infants Acetaminophen SUSPENSION/ DROPS ORAL
20040413 OTC MONOGRAPH NOT FINAL part343 American Sales Company
ACETAMINOPHEN 80 mg/.8mL
41520-012_92e168fe-aa61-49a5-8aa0-2bf749c96a90 41520-012 HUMAN OTC DRUG
Pain Relief ES Acetaminophen TABLET ORAL 20140610
OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN 500
mg/1
41520-013_82c768b4-b18a-49eb-afd5-766daa35720b 41520-013 HUMAN OTC DRUG
CareOne Allergy and congestion relief "Loratadine, Pseudoephedrine"
50 American Sales Company LORATADINE; PSEUDOEPHEDRINE SULFATE 5; 120
mg/1; mg/1
41520-014_14bbf582-8a8e-4d2b-ae75-9d346716213d 41520-014 HUMAN OTC DRUG
Care One Cold Multi Symptom "Acetaminophen, Chlorpheniramine Maleate
, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride" "TABLET, FILM CO
ATED" ORAL 20070626 OTC MONOGRAPH FINAL part341 American
Sales Company ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROB
41520-016_7e943bcb-5e84-45eb-bcc7-d6b75afeea79 41520-016 HUMAN OTC DRUG
CAREONE Triple Antibiotic "Bacitracin Zinc, Neomycin Sulfate, and Polymyxi
n B Sulfate" OINTMENT TOPICAL 19951214 OTC MONOGRAPH FI
NAL part333B American Sales Company BACITRACIN ZINC; NEOMYCIN SULFAT
41520-018_78734dd4-3206-4d36-aeeb-8a5c4b481013 41520-018 HUMAN OTC DRUG
Tussin DM "Dextromethorphan Hydrobromide, GUAIFENESIN" LIQUID
ORAL 20090603 OTC MONOGRAPH FINAL part341 American Sales C
ompany DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL
41520-025_960fd57b-8c75-4d37-bd67-bc017f70844c 41520-025 HUMAN OTC DRUG
Childrens Allergy Diphenhydramine Hydrochloride LIQUID ORAL
20090829 OTC MONOGRAPH FINAL part341 American Sales Company
41520-027_da0eb90a-2486-451b-8f85-75a1a82efc4f 41520-027 HUMAN OTC DRUG
care one allergy eye Ketotifen Fumarate SOLUTION/ DROPS OPHTHALM
IC 20100830 ANDA ANDA077958 American Sales Company
KETOTIFEN FUMARATE 0.25 mg/mL
41520-046_b3fcdd00-c746-470d-b4c4-52764d8f647d 41520-046 HUMAN OTC DRUG
care one pain relief Acetaminophen "TABLET, COATED" ORAL
ACETAMINOPHEN 500 mg/1
41520-047_b093bb80-081d-4bdf-95be-3b751422846f 41520-047 HUMAN OTC DRUG
care one acid reducer Ranitidine TABLET ORAL 20080213
ANDA ANDA078653 American Sales Company RANITIDINE HYDROCHLORIDE
150 mg/1
41520-049_e376e002-c66b-4941-bb8b-23325116f3f8 41520-049 HUMAN OTC DRUG
Care One Pain Relief "Camphor, Menthol, Methyl Salicylate" CREAM
TOPICAL 20080801 OTC MONOGRAPH NOT FINAL part348 American Sales C
ompany CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 4; 10; 30 g/100g;
g/100g; g/100g
41520-050_b6decf21-22a4-4370-a680-e713471b9718 41520-050 HUMAN OTC DRUG
Care One Ibuprofen PM diphenhydramine citrate and ibuprofen "TABLET,
COATED" ORAL 20090220 ANDA ANDA079113 American
Sales Company DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1
41520-052_b3dd331c-6d0b-43c8-90e7-0525d95aa889 41520-052 HUMAN OTC DRUG
CareOne Nighttime Sleep Aid Diphenhydramine HCl "CAPSULE, LIQUID
FILLED" ORAL 20140128 OTC MONOGRAPH FINAL part338
American Sales Company DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1
41520-054_28cb9586-c10d-498b-a8f8-4bc223a87c2f 41520-054 HUMAN OTC DRUG
careone suphedrine 12 hour relief non drowsy Pseudoephedrine Hydrochl
oride "TABLET, FILM COATED, EXTENDED RELEASE" ORAL 20040511
ANDA ANDA075153 American Sales Company PSEUDOEPHEDRINE HYDROCHLORIDE
120 mg/1
41520-057_85d7852d-d08c-4455-a776-7a14930caef1 41520-057 HUMAN OTC DRUG
care one ibuprofen infants ibuprofen SUSPENSION ORAL 20040511
ANDA ANDA075217 American Sales Company IBUPROFEN 50 mg/1.25m
L
41520-060_b530651b-a612-44b8-9929-d93994e3d86f 41520-060 HUMAN OTC DRUG
Minral Oil Mineral Oil OIL ORAL; TOPICAL 20090416
OTC MONOGRAPH NOT FINAL part334 American Sales Company MINERAL OIL 15
mL/15mL
41520-061_a82766e1-af46-4973-a60f-2c96313c8580 41520-061 HUMAN OTC DRUG
CareOne Childrens Pain and Fever Acetaminophen SUSPENSION
ORAL 20040413 OTC MONOGRAPH NOT FINAL part343 American Sales C
ompany ACETAMINOPHEN 160 mg/5mL
41520-065_949538e3-871f-4107-87de-02dff42abbbf 41520-065 HUMAN OTC DRUG
care one nasal extra moisturizing Oxymetazoline HCl SPRAY NASAL
OXYMETAZOLINE HYDROCHLORIDE 0.05 g/100mL
41520-072_50185657-0694-4e2f-ab73-971d1af11467 41520-072 HUMAN OTC DRUG
Night Time Cough Cherry "DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCI
NATE" LIQUID ORAL 20090908 OTC MONOGRAPH FINAL part341
American Sales Company DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
15; 135 mg/15mL; mg/5mL
41520-074_7819db1e-41cd-4b24-bfb9-c6285fddce92 41520-074 HUMAN OTC DRUG
care one ibuprofen ib Ibuprofen "TABLET, COATED" ORAL
20060509 ANDA ANDA077349 American Sales Company IBUPROFE
N 200 mg/1
41520-076_eb308349-f997-4748-808d-2cdd0edec392 41520-076 HUMAN OTC DRUG
CAREONE Antibiotic Plus Pain Relief "Neomycin Sulfate, Polymyxin B Sulfate,
and Pramoxine Hydrochloride" CREAM TOPICAL 20120321 OTC MONO
GRAPH FINAL part333B American Sales Company NEOMYCIN SULFATE; POLYMY
XIN B SULFATE; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [iU]/g; mg/g
41520-078_946d9593-9487-48f6-9b88-3403453673a0 41520-078 HUMAN OTC DRUG
Milk of Magnesia Original MAGNESIUM HYDROXIDE SUSPENSION
ompany MAGNESIUM HYDROXIDE 1200 mg/15mL
41520-079_74d3ff13-7dde-4349-8959-89f23bd0cfe3 41520-079 HUMAN OTC DRUG
CAREONE INSTANT HAND SANITIZER WITH ALOE AND VITAMIN E ETHYL ALCOHOL LIQUID
SALES COMPANY ALCOHOL 700 mg/mL
41520-080_0fa5f25a-5ea8-4039-8716-8cfce68987d1 41520-080 HUMAN OTC DRUG
Antifungal Foot Terbinafine Hydrochloride CREAM TOPICAL 20070702
ANDA ANDA077511 American Sales Company TERBINAFINE HYDROCHLORIDE
1 g/100g
41520-081_451c7f45-8032-4839-b113-259f5a5ce7dd 41520-081 HUMAN OTC DRUG
Milk of Magnesia Mint MAGNESIUM HYDROXIDE SUSPENSION ORAL
41520-083_519784c5-f531-40d8-9936-5facc9660b2a 41520-083 HUMAN OTC DRUG
care one ibuprofen cold and sinus "Ibuprofen, Pseudoephedrine Hydr
ochloride" "TABLET, SUGAR COATED" ORAL 20040511 ANDA
ANDA074567 American Sales Company IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
200; 30 mg/1; mg/1
41520-085_c09b23f3-4ca7-44fd-aec5-7cf6e5f4253b 41520-085 HUMAN OTC DRUG
Childrens Loratadine Loratadine SOLUTION ORAL 20040820
ANDA ANDA076805 American Sales Company LORATADINE 5 mg/5mL
41520-092_e823d719-dac1-4b49-aed1-b1d6201158cc 41520-092 HUMAN OTC DRUG
Care One Childrens Loratadine Loratadine SOLUTION ORAL
20100227 ANDA ANDA076805 American Sales Company LORATADI
NE 5 mg/5mL
41520-094_31af8713-b652-4773-a320-a6af360915fb 41520-094 HUMAN OTC DRUG
care one nasal decongestant pe maximum strength non drowsy Phenylephrine Hy
drochloride TABLET ORAL 20050517 OTC MONOGRAPH FINAL
part341 American Sales Company PHENYLEPHRINE HYDROCHLORIDE 10 mg/1
41520-096_f2659925-80c8-411a-83b9-48fe24dfb9a5 41520-096 HUMAN OTC DRUG
care one flu and severe cold and cough daytime "Acetaminophen, Dextromethorphan
Hydrobromide, Phenylephrine Hydrochloride" "POWDER, FOR SOLUTION" ORAL
650; 20; 10 mg/1; mg/1; mg/1
41520-098_c921b3c8-7e7e-4bc3-a95c-ab6bf6d141da 41520-098 HUMAN OTC DRUG
Tussin Cough Long Acting DEXTROMETHORPHAN HYDROBROMIDE LIQUID
ompany DEXTROMETHORPHAN HYDROBROMIDE 10 mg/5mL
41520-100_074a75f0-e886-4d9f-85ad-400e8153a151 41520-100 HUMAN OTC DRUG
Tussin Sugar Free Cough "Dextromethorphan Hydrobromide, GUAIFENESIN"
LIQUID ORAL 20090210 OTC MONOGRAPH FINAL part341 American
Sales Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL;
mg/5mL
41520-104_a09d2e9f-2a50-4daf-ac4b-25118aa69110 41520-104 HUMAN OTC DRUG
CAREONE TAHITIAN COCONUT TRICLOSAN LIQUID TOPICAL 20140205
OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN
4.6 mg/mL
41520-105_4c0b566a-25dc-4ae4-9cb8-cb992c1f5ff2 41520-105 HUMAN OTC DRUG
Care One Pain Relief Childrens Acetaminophen SUSPENSION ORAL
ACETAMINOPHEN 160 mg/5mL
41520-107_15148e63-976e-4eb4-835f-bdfb96036d44 41520-107 HUMAN OTC DRUG
CAREONE VANILLA BROWN SUGAR TRICLOSAN LIQUID TOPICAL 20140206
4.6 mg/mL
41520-110_1ed29fd2-8aba-46a9-bce9-31b792b62b0d 41520-110 HUMAN OTC DRUG
CareOne Nicotine Nicotine Polacrilex "GUM, CHEWING" ORAL
20061218 ANDA ANDA076779 American Sales Company NICOTINE
4 mg/1
41520-112_773d074c-dde4-4f4c-ba61-b65cab9a12b4 41520-112 HUMAN OTC DRUG
GRAPH FINAL part341 American Sales Company ACETAMINOPHEN; DEXTROMETHORPHAN
L
41520-113_b0895705-7579-4e4a-920c-caaf632f94b9 41520-113 HUMAN OTC DRUG
Night Time Cherry Pseudo-Free "Acetaminophen, Dextromethorphan Hydrobr
omide, Doxylamine Succinate," LIQUID ORAL 20090923 OTC MONO
L
41520-114_883eaed8-4c55-4672-b814-e7715f60c3c1 41520-114 HUMAN OTC DRUG
Night Time Cherry Pseudo-Free "Acetaminophen, Dextromethorphan Hydrobr
L
41520-116_54a91980-4277-40b5-9333-2cd61effa823 41520-116 HUMAN OTC DRUG
CARE ONE VANILLA BEAN TRICLOSAN LIQUID TOPICAL 20131027
4.6 mg/mL
41520-117_8b96d395-1038-4347-87e3-a82e83750bf5 41520-117 HUMAN OTC DRUG
CareOne Lansoprazole Lansoprazole "CAPSULE, DELAYED RELEASE"
ORAL 20120524 ANDA ANDA202319 American Sales Company
LANSOPRAZOLE 15 mg/1
41520-118_d2b5480d-facb-4267-b021-298f28d6199d 41520-118 HUMAN OTC DRUG
CARE ONE PUMPKIN PIE TRICLOSAN LIQUID TOPICAL 20131027
4.6 mg/mL
41520-119_e51b56c4-83d8-4cfc-a33c-8961c1d8a4fd 41520-119 HUMAN OTC DRUG
CARE ONE PEPPERMINT SWIRL TRICLOSAN LIQUID TOPICAL 20131027
4.6 mg/mL
41520-121_4f445ea4-2128-42b9-8aec-a30ddeb1c198 41520-121 HUMAN OTC DRUG
CARE ONE PINE TRICLOSAN LIQUID TOPICAL 20131027
4.6 mg/mL
41520-123_34cf9cca-c69f-4d0b-8c44-06945dbd3750 41520-123 HUMAN OTC DRUG
CAREONE COUNTRY APPLE TRICLOSAN LIQUID TOPICAL 20140205
4.6 mg/mL
41520-125_bee1996d-dcf7-4dde-a9c2-c2e80700c6ab 41520-125 HUMAN OTC DRUG
CAREONE APPLE BERRY TRICLOSAN LIQUID TOPICAL 20140205
4.6 mg/mL
41520-126_8ae220b6-3b84-4ca1-95fd-c2f81336ad8e 41520-126 HUMAN OTC DRUG
Tussin CF "DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRI
NE HYDROCHLORIDE" LIQUID ORAL 20090826 OTC MONOGRAPH FI
NAL part341 American Sales Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENES
41520-130_94c63831-e01b-4bca-b7e8-2922a93e8b3c 41520-130 HUMAN OTC DRUG
care one pain relief childrens Acetaminophen SUSPENSION ORAL
41520-133_f9bbcb02-1cc0-4980-bef9-02758190ce9f 41520-133 HUMAN OTC DRUG
care one flu and sore throat "acetaminophen,pheniramine maleate, phen
ylephrine hydrochloride" "POWDER, FOR SUSPENSION" ORAL 20101228
OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; PHENIRAMI
NE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/15000mg; mg/15000mg;
mg/15000mg
41520-139_45144782-1d54-486d-b19e-148b09e99a28 41520-139 HUMAN OTC DRUG
Care One Cold and Allergy "Chlorpheniramine maleate, Phenylephrine
HCl" "TABLET, FILM COATED" ORAL 20060921 OTC MONOGRAPH FI
NAL part341 American Sales Company CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE
HYDROCHLORIDE 4; 10 mg/1; mg/1
41520-140_c41cafb1-8f08-484d-be75-e7f2bbc5ccd2 41520-140 HUMAN OTC DRUG
care one all day pain relief Naproxen sodium "TABLET, FILM COATED"
NAPROXEN SODIUM 220 mg/1
41520-141_11d463af-fb95-470a-a57c-87004189954b 41520-141 HUMAN OTC DRUG
care one acid reducer original strength Famotidine TABLET ORAL
20091009 ANDA ANDA075400 American Sales Company FAMOTIDI
NE 10 mg/1
41520-143_c6376a12-2f8d-411b-9728-e699fe87f2f6 41520-143 HUMAN OTC DRUG
41520-145_2c423433-ec38-4b37-8fb7-b583bf939550 41520-145 HUMAN OTC DRUG
CareOne Mucus Relief Cold and Sinus "Acetaminophen, guaifenesin, phenylephri
ne HCl" "TABLET, COATED" ORAL 20130823 OTC MONOGRAPH FI
NAL part341 American Sales Company ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRIN
E HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1
41520-153_54f62564-ffed-4f59-8ea0-178687adb06a 41520-153 HUMAN OTC DRUG
Everyday Clean Dandruff Pyrithione Zinc SHAMPOO TOPICAL 19950215
OTC MONOGRAPH FINAL part358H American Sales Company PYRITHIONE ZINC
1 kg/100L
41520-154_84c43793-98e4-4e68-a3bc-3e7222135568 41520-154 HUMAN OTC DRUG
CareOne Miconazole 3 Miconazole nitrate KIT 20140413
ANDA ANDA075329 American Sales Company
41520-155_0ce7ec52-263b-49a6-934b-71c850728da0 41520-155 HUMAN OTC DRUG
Flu Relief Therapy Day Time "Acetaminophen, Dextromethorphan Hydrobr
omide, Phenylephrine Hydrochloride" LIQUID ORAL 20090908
OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; DEXTROMET
mg/15mL; mg/15mL
41520-160_68413266-83fd-4960-9380-10280c9afd44 41520-160 HUMAN OTC DRUG
CareOne Hemorrhoidal "cocoa butter, phenylephrine hcl" SUPPOSIT
ORY RECTAL 20130102 OTC MONOGRAPH FINAL part346 American
Sales Company COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2.135; .0065
g/2.5g; g/2.5g
41520-161_1dea76ff-ad67-481b-af80-3a2d70836fde 41520-161 HUMAN OTC DRUG
ANTIBACTERIAL FOAMING TRICLOSAN LIQUID TOPICAL 20110516
0.46 mL/100mL
41520-163_c46e2004-2fba-4fe4-915b-47490463e621 41520-163 HUMAN OTC DRUG
Anticavity Sodium Fluoride MOUTHWASH ORAL 20050912
OTC MONOGRAPH FINAL part355 American Sales Company SODIUM FLUORIDE 1
mg/mL
41520-165_65605c3c-749a-48fd-a7a8-262f45b64141 41520-165 HUMAN OTC DRUG
ANTIBACTERIAL FOAMING GREEN TEA TRICLOSAN LIQUID TOPICAL 20110516
0.46 mL/100mL
41520-166_f3938282-dcd1-433f-ad74-87cab8b32409 41520-166 HUMAN OTC DRUG
care one ibuprofen childrens Ibuprofen SUSPENSION ORAL
N 100 mg/5mL
41520-167_a25acb68-7365-456b-b517-a6745fa64768 41520-167 HUMAN OTC DRUG
ANTIBACTERIAL FOAMING HAND SP CUCUMBER AND MELON TRICLOSAN
LIQUID TOPICAL 20110524 OTC MONOGRAPH NOT FINAL part333E
AMERICAN SALES COMPANY TRICLOSAN 0.6 mL/100mL
41520-168_d59294c7-2de7-4a2c-819e-f1e0fccf3eb0 41520-168 HUMAN OTC DRUG
0.6 mL/100mL
41520-169_1af8d91e-b018-466d-86d1-8d19670be829 41520-169 HUMAN OTC DRUG
0.46 mL/100mL
41520-170_b0d260e6-b973-4fb5-825f-75f28e0ff93f 41520-170 HUMAN OTC DRUG
ANTIBACTERIAL FOAMING OLIVE AND ALOE TRICLOSAN LIQUID TOPICAL 20110121
0.3 mL/100mL
41520-170_b6f080b6-4f77-4067-8da1-97bfee9a901e 41520-170 HUMAN OTC DRUG
ANTIBACTERIAL FOAMING OLIVE AND ALOE TRICLOSAN LIQUID TOPICAL 20111025
0.3 mL/100mL
41520-171_a57be6d4-8a5e-4f92-8758-7e2a9522d3f8 41520-171 HUMAN OTC DRUG
ANTIBACTERIAL FOAMING BERRY MEDLEY TRICLOSAN LIQUID TOPICAL 20110121
0.3 mL/100mL
41520-173_aff4c53b-24bd-4b2d-8f47-75a048383e11 41520-173 HUMAN OTC DRUG
careone lice "Piperonyl Butoxide, Pyrethrum Extract" KIT
20070926 OTC MONOGRAPH FINAL part358G American Sales C
ompany
41520-173_f0ac01e5-4bd8-4c7c-9e15-9b7addd8e407 41520-173 HUMAN OTC DRUG
careone lice "Piperonyl Butoxide, Pyrethrum Extract" KIT
20070926 OTC MONOGRAPH FINAL part358G American Sales C
ompany
41520-175_56eb4917-74dd-4ea3-872b-fd546a914392 41520-175 HUMAN OTC DRUG
care one pain relief childrens Acetaminophen SUSPENSION ORAL
41520-178_47d2da7d-230b-413c-8267-8408cdc6a95d 41520-178 HUMAN OTC DRUG
CAREONE INSTANT HAND SANITIZER WITH MOISTURIZERS AND VITAMIN E ETHYL ALCOHOL
AMERICAN SALES COMPANY ALCOHOL 700 mg/mL
41520-179_b3d9bae4-da40-4217-833a-8f8d111514fb 41520-179 HUMAN OTC DRUG
care one calcium antacid Calcium carbonate "TABLET, CHEWABL
E" ORAL 20040301 OTC MONOGRAPH FINAL part331 American
Sales Company CALCIUM CARBONATE 750 mg/1
41520-187_227f52d0-b44e-4969-8f77-4c0fc14be1b1 41520-187 HUMAN OTC DRUG
Care One pain relief extra strength Acetaminophen "TABLET, COATED"
ompany ACETAMINOPHEN 500 mg/1
41520-188_46794d2e-8fe6-490d-9cfa-ba9b6c209ad6 41520-188 HUMAN OTC DRUG
careone hemorrhoidal "mineral oil, petrolatum, phenylephrine HCl"
OINTMENT RECTAL 20140720 OTC MONOGRAPH FINAL part346
American Sales Company MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE
14; 74.9; .25 g/100g; g/100g; g/100g
41520-189_975ecee8-52cd-4a3c-a304-8be3a3d24c80 41520-189 HUMAN OTC DRUG
CareOne Childrens All Day Allergy Cetirizine HCl LIQUID ORAL
20131227 ANDA ANDA204226 American Sales Company CETIRIZI
NE HYDROCHLORIDE 5 mg/5mL
41520-190_ca40d723-dbc2-4b81-b176-03f1e6f15333 41520-190 HUMAN OTC DRUG
CARE ONE ANTIBACTERIAL RUM RAISIN TRICLOSAN LIQUID TOPICAL
20120927 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES C
OMPANY TRICLOSAN 3 mg/mL
41520-191_58455c76-6876-4299-82d7-1f859ad77b84 41520-191 HUMAN OTC DRUG
CARE ONE ANTIBACTERIAL TANGERINE SPICE TRICLOSAN LIQUID TOPICAL
41520-192_b4e3c65d-3b02-4099-b0aa-17ab18104bd9 41520-192 HUMAN OTC DRUG
CARE ONE ANTIBACTERIAL SNOW KISSED PEAR TRICLOSAN LIQUID TOPICAL
41520-193_23c03d48-9b68-4a1e-bc3b-8229dd2f5d00 41520-193 HUMAN OTC DRUG
CARE ONE ANTIBACTERIAL PEPPERMINT SWIRL TRICLOSAN LIQUID TOPICAL
41520-196_3db799d5-7bcb-4df9-9c02-957d9bc90591 41520-196 HUMAN OTC DRUG
CARE ONE CREAMY COCONUT TRICLOSAN LIQUID TOPICAL 20130220
4.6 mg/mL
41520-197_fc1335ea-8a88-4ffb-bac4-9be715b3804c 41520-197 HUMAN OTC DRUG
CARE ONE SUN KISSED PEAR TRICLOSAN LIQUID TOPICAL 20130220
4.6 mg/mL
41520-198_c2cd2e41-2c13-4866-b710-c454b6b784e6 41520-198 HUMAN OTC DRUG
CARE ONE VANILLA APPLE BLOSSOM TRICLOSAN LIQUID TOPICAL 20130220
4.6 mg/mL
41520-199_0af3dcc2-dbef-4aa2-9298-c90da146dd42 41520-199 HUMAN OTC DRUG
CARE ONE LEMON VERBENA TRICLOSAN LIQUID TOPICAL 20130220
4.6 mg/mL
41520-201_d3c495fe-e59b-42f6-b986-dee266ae3c18 41520-201 HUMAN OTC DRUG
1 hydrocortisone maximum strength hydrocortisone OINTMENT
ompany HYDROCORTISONE 1 g/100g
41520-206_9c3033fc-6ae0-4119-a6ef-0d732f3e33a5 41520-206 HUMAN OTC DRUG
Care One Nicotine Nicotine Polacrilex "GUM, CHEWING" ORAL
2 mg/1
41520-207_4050612d-7765-44e7-82e8-55470d6f653b 41520-207 HUMAN OTC DRUG
CareOne Pain Relief Acetaminophen LIQUID ORAL 20110902
mg/5mL
41520-210_ca6269c5-59dd-492d-9df3-e2296b855ceb 41520-210 HUMAN OTC DRUG
Antiseptic Mouth rinse Eucalyptol MOUTHWASH ORAL 20100802
OTC MONOGRAPH NOT FINAL part348 American Sales Company EUCALYPTOL; MENTHOL; MET
HYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/10
0L
41520-213_8dbbc90f-10cc-4f95-9d3d-ae49c48598ff 41520-213 HUMAN OTC DRUG
Anticavity Fluoride Rinse Sodium Fluoride MOUTHWASH ORAL
SODIUM FLUORIDE 0.05 kg/100L
41520-214_35cc9dec-3ff1-49d4-be58-bd69da9e6cb2 41520-214 HUMAN OTC DRUG
care one miconazole 7 Miconazole nitrate CREAM VAGINAL 19991011
ANDA ANDA074760 American Sales Company MICONAZOLE NITRATE 2
g/100g
41520-217_84c55280-f87a-4434-9082-b6fa7c8051c5 41520-217 HUMAN OTC DRUG
care one pain relief 8 hour Acetaminophen "TABLET, FILM COATED, EXTENDED R
ELEASE" ORAL 20051129 ANDA ANDA075077 American Sales C
41520-220_a1718e1a-a066-47fd-b6db-d400f5dc9a6b 41520-220 HUMAN OTC DRUG
CAREONE ETHYL ALCOHOL LIQUID TOPICAL 20130606 OTC MONO
GRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 620 mg/mL
41520-223_1cc5e2f7-1f6e-4ecb-a7ff-d1a7467bc7a8 41520-223 HUMAN OTC DRUG
CAREONE INSTANT HAND SANITIZER WITH ALOE AND VITAMIN E ETHYL ALCOHOL
GEL TOPICAL 20110114 OTC MONOGRAPH NOT FINAL part333E
AMERICAN SALES COMPANY ALCOHOL 62 mL/100mL
41520-223_24f0f587-3a19-4f45-8357-06daca4ef3db 41520-223 HUMAN OTC DRUG
CAREONE INSTANT HAND SANITIZER WITH ALOE AND VITAMIN E ETHYL ALCOHOL
GEL TOPICAL 20110708 OTC MONOGRAPH NOT FINAL part333E
AMERICAN SALES COMPANY ALCOHOL 62 mL/100mL
41520-224_639f7cc2-9fe4-43c3-a2bb-04bb528d74af 41520-224 HUMAN OTC DRUG
Care One anti diarrheal loperamide hydrochloride Loperamide Hydrochloride
American Sales Company LOPERAMIDE HYDROCHLORIDE 2 mg/1
41520-225_99db10f5-33ec-4b42-a450-7764118a8a3a 41520-225 HUMAN OTC DRUG
INSTANT HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20130201
OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 62
mL/100mL
41520-227_a51f78fc-c6dc-43bd-b963-5e62533acbe7 41520-227 HUMAN OTC DRUG
CAREONE INSTANT HAND SANITIZER LEMON ETHYL ALCOHOL GEL TOPICAL
OMPANY ALCOHOL 62 mL/100mL
41520-227_ed486ffb-3bfd-416c-8ae8-c5b52b3407fe 41520-227 HUMAN OTC DRUG
Care One Pain Relief Acetaminophen "TABLET, COATED" ORAL
41520-230_ecc5a12f-507c-4141-af1b-11ad9c6d4211 41520-230 HUMAN OTC DRUG
INSTANT HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20111005
mL/100mL
41520-234_85e22ae3-53dd-405a-92a5-93b35cd4458c 41520-234 HUMAN OTC DRUG
Care One cold head congestion "Acetaminophen, Dextromethorphan HBr, Gu
aifenesin, Phenylephrine HCl" "TABLET, COATED" ORAL 20081024
HORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5
mg/1; mg/1; mg/1; mg/1
41520-240_36893d28-9257-46f2-aa6d-7ea6ce3e324c 41520-240 HUMAN OTC DRUG
FOAMING HAND SANITIZER WITH ALOE BENZALKONIUM CHLORIDE GEL TOPICAL
OMPANY BENZALKONIUM CHLORIDE 0.1 mL/100mL
41520-241_286c994c-9d23-458a-933d-5d1bf760842a 41520-241 HUMAN OTC DRUG
CAREONE ANTIMICROBIAL FOAMING HAND SP FALLING RAIN BENZETHONIUM CHL
ORIDE LIQUID TOPICAL 20110525 OTC MONOGRAPH NOT FINAL part333E
AMERICAN SALES COMPANY BENZETHONIUM CHLORIDE 0.1 mL/100mL
41520-250_2d1a1a77-945e-4bd8-b357-1320bf1a8738 41520-250 HUMAN OTC DRUG
care one cold multi symptom "Acetaminophen, Chlorpheniramine maleate
, Dextromethorphan HBr, Phenylephrine HCl" KIT 20081010
OTC MONOGRAPH FINAL part341 American Sales Company
41520-251_a20ecd32-cc14-4ee3-8491-29d5a4392b53 41520-251 HUMAN OTC DRUG
care one analgesic Trolamine Salicylate CREAM TOPICAL 20080603
OTC MONOGRAPH NOT FINAL part348 American Sales Company TROLAMINE SALICYLATE
10 g/100g
41520-255_15f63d40-276c-4c02-9f8c-0354e4779916 41520-255 HUMAN OTC DRUG
care one ibuprofen Ibuprofen SUSPENSION/ DROPS ORAL
N 50 mg/1.25mL
41520-259_9da3ed9b-bcea-4b31-a766-204837c3a7bd 41520-259 HUMAN OTC DRUG
care one aspirin Aspirin "TABLET, CHEWABLE" ORAL 20051122
OTC MONOGRAPH NOT FINAL part343 American Sales Company ASPIRIN 81 mg/1
41520-270_ba3e9c30-28b9-4604-8af8-00d1f2eed873 41520-270 HUMAN OTC DRUG
Sinus Headache PE Maximum Strenght Non- Drowsy Acetaminophen and Phenyl
ephrine HCl TABLET ORAL 20140612 OTC MONOGRAPH FINAL
part341 American Sales Company ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
325; 5 mg/1; mg/1
41520-271_674e7d80-71a7-401e-97d9-761fddea2aef 41520-271 HUMAN OTC DRUG
Careone Acid Reducer Ranitidine TABLET ORAL 20090529
ANDA ANDA076760 American Sales Company RANITIDINE HYDROCHLORIDE
75 mg/1
41520-272_2516654f-5534-4017-81c5-cc5ba5c5b6b7 41520-272 HUMAN OTC DRUG
care one sinus congestion and pain "Acetaminophen, Phenylephrine HCl"
"TABLET, FILM COATED" ORAL 20070207 OTC MONOGRAPH FINAL
part341 American Sales Company ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
325; 5 mg/1; mg/1
41520-280_d5c6ed63-74af-4354-a64a-ea6d883a6ac3 41520-280 HUMAN OTC DRUG
HAND SANITIZER BENZALKONIUM CHLORIDE GEL TOPICAL 20111006
OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY BENZALKONIUM CHL
ORIDE 0.1 mL/100mL
41520-281_5bb51652-ea78-4727-91c3-2e94e7cc4abe 41520-281 HUMAN OTC DRUG
ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20110622
0.15 mL/100mL
41520-282_bc2f5094-0d8b-43a0-aae7-713651df52b1 41520-282 HUMAN OTC DRUG
0.15 mL/100mL
41520-283_cdc6cd57-b88d-43d4-a1b2-640c109e694b 41520-283 HUMAN OTC DRUG
0.15 mL/100mL
41520-288_6243d377-7a15-48ec-b7d3-32a8c9114e7b 41520-288 HUMAN OTC DRUG
careone mucus relief childrens Guaifenesin LIQUID ORAL 20070808
OTC MONOGRAPH FINAL part341 American Sales Company GUAIFENESIN 100
mg/5mL
41520-289_b030dd91-fc63-4519-b10d-0a0b86cd067e 41520-289 HUMAN OTC DRUG
care one pain relief infants Acetaminophen SUSPENSION/ DROPS ORAL
41520-293_084b5ccb-cd0b-4afe-937f-609808367609 41520-293 HUMAN OTC DRUG
ANTIBACTERIAL MANDARIN AND POMELO TRICLOSAN LIQUID TOPICAL 20110401
0.15 mL/100mL
41520-294_f4ba4490-4c67-4892-8a12-be2dd8860431 41520-294 HUMAN OTC DRUG
careone hair regrowth treatment Minoxidil "AEROSOL, FOAM" TOPICAL
20120727 ANDA ANDA091344 American Sales Company MINOXIDI
L 5 g/100g
41520-295_3ac60220-ce34-4361-9dab-10a05af5b38f 41520-295 HUMAN OTC DRUG
Itch Relief "Diphenhydramine HCl, Zinc Acetate" SPRAY TOPICAL
DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 kg/100L; kg/100L
41520-296_16fdc6f9-4ea8-4df3-9ebf-4862a015b654 41520-296 HUMAN OTC DRUG
Dry Scalp Care Pyrithione Zinc SHAMPOO TOPICAL 20090605
1 kg/100L
41520-300_787ea330-eb37-4843-bece-c1ce47ece2d7 41520-300 HUMAN OTC DRUG
CareOne Pain Relief Acetaminophen "TABLET, FILM COATED" ORAL
41520-302_fd2dd91a-8204-4098-b37b-9c3b1903e983 41520-302 HUMAN OTC DRUG
careone stomach relief Bismuth subsalicylate SUSPENSION ORAL
BISMUTH SUBSALICYLATE 525 mg/30mL
41520-304_a0c35e06-c9e9-438e-8224-d4760b6e2aff 41520-304 HUMAN OTC DRUG
care one nasal original oxymetazoline hydrochloride SPRAY NASAL
41520-305_9e0e3507-73d5-4f52-bd31-6f2448102d26 41520-305 HUMAN OTC DRUG
CAREONE Clotrimazole Clotrimazole CREAM TOPICAL 19930831
OTC MONOGRAPH FINAL part333C American Sales Company CLOTRIMAZOLE
10 mg/g
41520-306_df5e13b3-82ca-456f-89d4-288d3b69fb6c 41520-306 HUMAN OTC DRUG
care one clearlax Polyethylene Glycol 3350 "POWDER, FOR SOL
UTION" ORAL 20091009 ANDA ANDA090685 American Sales C
ompany POLYETHYLENE GLYCOL 3350 17 g/17g
41520-309_0d13a818-a8c2-4387-9849-274f3180b775 41520-309 HUMAN OTC DRUG
Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20110210
1 g/100mL
41520-310_7e4b06a2-2590-49e1-b0cb-e5f4bb7306bd 41520-310 HUMAN OTC DRUG
CareOne Adult Tussin Guaifenesin SYRUP ORAL 20040504
OTC MONOGRAPH FINAL part341 American Sales Company GUAIFENESIN 200
mg/10mL
41520-311_e0c1af02-6dbf-4d10-844b-3a388301343f 41520-311 HUMAN OTC DRUG
Dandruff Pyrithione zinc LOTION/SHAMPOO TOPICAL 20040709
1 g/100mL
41520-313_0f14aa75-5c61-4e9e-8c01-9ddb132612bc 41520-313 HUMAN OTC DRUG
CAREONE BACITRACIN BACITRACIN OINTMENT TOPICAL 20120301
OTC MONOGRAPH FINAL part333B AMERICAN SALES COMPANY BACITRACIN
500 [USP'U]/g
41520-314_03a904e7-32e6-4cf7-9c69-9b61b86e93f0 41520-314 HUMAN OTC DRUG
CAREONE ALLERGY "DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE" CREAM
TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part348 AMERICAN SALES C
OMPANY DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g
41520-318_227c35b3-485e-47e9-89f7-d4d0bf7b0d24 41520-318 HUMAN OTC DRUG
Antiseptic Mouth Rinse EUCALYPTOL MOUTHWASH ORAL 19890313
OTC MONOGRAPH NOT FINAL part356 American Sales Company EUCALYPTOL; MENTHOL; MET
HYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/10
0L
41520-319_54b8cd41-5a36-43cb-86da-7573073cca41 41520-319 HUMAN OTC DRUG
Care One hydrocortisone maximum strength Hydrocortisone CREAM TOPICAL
41520-321_52107212-7232-4349-8481-7711bb200c3d 41520-321 HUMAN OTC DRUG
Care One Acid Reducer plus Antacid Dual Action "Famotidine, Calcium Car
bonate,Magnesium Hydroxide" "TABLET, CHEWABLE" ORAL 20080801
ANDA ANDA077355 American Sales Company CALCIUM CARBONATE; FAMOTIDINE; M
AGNESIUM HYDROXIDE 800; 10; 165 mg/1; mg/1; mg/1
41520-323_161c0726-6d59-4563-9106-a705ea68f8f4 41520-323 HUMAN OTC DRUG
CareOne Lubricant Eye Plus carboxymethylcellulose sodium "SOLUTIO
N, GEL FORMING / DROPS" OPHTHALMIC 20130620 OTC MONOGRAPH FI
NAL part349 American Sales Company CARBOXYMETHYLCELLULOSE SODIUM 0.5
g/100mL
41520-328_3d6e2960-5484-4323-9498-a8456378c059 41520-328 HUMAN OTC DRUG
care one sore throat Phenol SPRAY ORAL 20031119
OTC MONOGRAPH NOT FINAL part356 American Sales Company PHENOL 1.4 g/100mL
41520-330_c261706c-37ef-4d7e-99c0-6b285675c7b7 41520-330 HUMAN OTC DRUG
CareOne Daytime Severe Cold and Cough Berry infused with Menthol and Green Tea
flavors "Acetaminophen, Dextromethorphan HBr and Phenylephrine HCL"
"GRANULE, FOR SOLUTION" ORAL 20130731 OTC MONOGRAPH FINAL
part341 American Sales Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PH
41520-332_fa3fad85-e5da-4258-97bb-4e0be6d134ac 41520-332 HUMAN OTC DRUG
careone milk of magnesia Magnesium hydroxide LIQUID ORAL
41520-333_220a48c3-2d87-4b82-8c41-caec5c77bc81 41520-333 HUMAN OTC DRUG
Acetaminophen Acetaminophen "TABLET, FILM COATED, EXTENDED RELEASE"
41520-335_911fdf0b-c30e-49e2-9311-8813dc2857a4 41520-335 HUMAN OTC DRUG
CareOne Nitetime Cold Flu Relief "Acetaminophen, Dextromethorphan
HBr, Doxylamine succinate" LIQUID ORAL 20130813 OTC MONO
GRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN; DEXTROMETHORPHAN
L
41520-336_a833a491-7e96-4c0e-b534-38f757335f9e 41520-336 HUMAN OTC DRUG
Acetaminophen-APAP 8 Hour Acetaminophen "TABLET, FILM COATED, EX
Sales Company ACETAMINOPHEN 650 mg/1
41520-337_c9aaf8d7-d5f2-4e15-ad6b-fcbf67a3f721 41520-337 HUMAN OTC DRUG
careone stomach relief Bismuth subsalicylate SUSPENSION ORAL
BISMUTH SUBSALICYLATE 1050 mg/30mL
41520-340_221825cd-4b71-4d97-ab9a-848552885f84 41520-340 HUMAN OTC DRUG
careone liquid antacid "aluminum hydroxide, magnesium hydroxide, simeth
icone" LIQUID ORAL 20120927 OTC MONOGRAPH FINAL part331
American Sales Company ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE
400; 40; 400 mg/5mL; mg/5mL; mg/5mL
41520-341_e5c46712-ee67-4760-84b4-818488718644 41520-341 HUMAN OTC DRUG
COTTONTAILS DIAPER RASH "LANOLIN, PETROLATUM" PASTE TOPICAL 20131216
OTC MONOGRAPH FINAL part347 AMERICAN SALES COMPANY LANOLIN; PETROLATUM
155; 534 mg/g; mg/g
41520-344_484c2d63-b12c-4477-9f75-661dde6ec559 41520-344 HUMAN OTC DRUG
Anticavity Rinse Fluoride Rinse Anticavity Rinse MOUTHWASH
ompany SODIUM FLUORIDE 0.0221 kg/100L
41520-352_91eb3e42-7527-4c5b-9d41-a8e5812bb713 41520-352 HUMAN OTC DRUG
care one nicotine Nicotine Polacrilex "GUM, CHEWING" ORAL
2 mg/1
41520-357_d5ca9f59-d086-40ef-9aff-2f5de75afb6c 41520-357 HUMAN OTC DRUG
careone antacid regular strength "Aluminum hydroxide, Magnesium hydroxide
, Simethicone" LIQUID ORAL 20121118 OTC MONOGRAPH FINAL
part331 American Sales Company ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDRO
XIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL
41520-358_3ab6149e-1782-4e22-8f55-b581909cd2e2 41520-358 HUMAN OTC DRUG
Care One Sinus and Allergy PE "Chlorpheniramine maleate, Phenylephrine
NAL part341 American Sales Company CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE
41520-359_81046216-9fbd-45b5-8a10-3524cdedcd61 41520-359 HUMAN OTC DRUG
CareOne Adult Tussin DM "Dextromethorphan HBr, Guaifenesin" LIQUID
41520-361_0be2f9dc-674b-4982-89e8-23d16a12553f 41520-361 HUMAN OTC DRUG
CareOne Allergy Medication Diphenhydramine Hydrochloride TABLET
ompany DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1
41520-365_bb28f4e0-6268-4214-9527-68dc989a4fe3 41520-365 HUMAN OTC DRUG
careone nicotine polacrilex Nicotine Polacrilex "GUM, CHEWING"
NICOTINE 2 mg/1
41520-368_9d588aa4-5175-4d23-9f6b-25703efef4d6 41520-368 HUMAN OTC DRUG
care one all day pain relief Naproxen Sodium "TABLET, FILM COATED"
41520-371_02c3af37-c67a-4b16-b5db-a5dca8f7632e 41520-371 HUMAN OTC DRUG
Care One Cold Multi Symptom "Acetaminophen, Dextromethorphan Hydrobr
omide, Phenylephrine Hydrochloride" "TABLET, FILM COATED" ORAL 20070606
/1; mg/1
41520-374_b6f2fe57-f7a2-498e-b334-16753636887a 41520-374 HUMAN OTC DRUG
Care One migraine relief "Acetaminophen, Aspirin, Caffeine"
American Sales Company ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65
mg/1; mg/1; mg/1
41520-376_838b1884-d709-48a7-a3a0-241c9424e65f 41520-376 HUMAN OTC DRUG
41520-381_fc39458f-5e32-4e8f-bdd8-d54a2702b725 41520-381 HUMAN OTC DRUG
CareOne Mucus Relief "Acetaminophen, Dextromethorphan HBr, Guaifenesi
n, Phenylephrine HCl" "TABLET, FILM COATED" ORAL 20130823
mg/1; mg/1; mg/1; mg/1
41520-384_2543912b-e6dd-46ca-8f0e-12603f6c28a7 41520-384 HUMAN OTC DRUG
CareOne Cough DM dextromethorphan polistirex SUSPENSION
DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL
41520-388_61cd15f7-ef27-40c3-af66-feda97b34465 41520-388 HUMAN OTC DRUG
care one nasal Oxymetazoline HCl SPRAY NASAL 20040720
OTC MONOGRAPH FINAL part341 American Sales Company OXYMETAZOLINE HYDROCHLOR
IDE 0.05 g/100mL
41520-390_b45eb1ac-b3fa-464c-9b16-e2df7bcd0df1 41520-390 HUMAN OTC DRUG
care one nose drops Phenylephrine hydrochloride LIQUID NASAL
PHENYLEPHRINE HYDROCHLORIDE 1 mL/100mL
41520-393_2ff5eb6b-2d04-401b-9f5c-bea8c87abaea 41520-393 HUMAN OTC DRUG
Care One Cold Head Congestion "Acetaminophen, Chlorpheniramine Maleate
ATED" ORAL 20070718 OTC MONOGRAPH FINAL part341 American
Sales Company ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROB
41520-394_5e090ef5-08bd-438f-8b02-f276b1a7bdd9 41520-394 HUMAN OTC DRUG
Care One Hemorrhoidal "Cocoa butter, Phenylephrine HCl, Shark liver oi
l" SUPPOSITORY RECTAL 20031209 OTC MONOGRAPH FINAL
part346 American Sales Company COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE; SHARK
LIVER OIL 2137.5; 75; 6.375 mg/1; mg/1; mg/1
41520-396_dc1f5035-69bf-4604-b92c-7a85ca4b9928 41520-396 HUMAN OTC DRUG
41520-397_e4625ed7-bd74-4f79-a5b7-7b89616b3b12 41520-397 HUMAN OTC DRUG
careone childrens pain and fever acetaminophen SUSPENSION
41520-399_c5ff7c16-4502-44cd-889d-5f4fb10d6379 41520-399 HUMAN OTC DRUG
careone infants pain relief acetaminophen SUSPENSION ORAL
41520-400_adeb9c3c-1bde-4a82-828e-1ddab94304fa 41520-400 HUMAN OTC DRUG
Care One Hemorrhoidal "Mineral oil, Petrolatum, Phenylephrine HCl, Sha
rk liver oil" OINTMENT TOPICAL 20040316 OTC MONOGRAPH FI
NAL part346 American Sales Company MINERAL OIL; PETROLATUM; PHENYLEPHRINE H
YDROCHLORIDE; SHARK LIVER OIL 14; 71.9; .25; 3 g/100g; g/100g; g/100g;
g/100g
41520-401_8ec60879-f4d4-45f1-8239-013c709bd1ce 41520-401 HUMAN OTC DRUG
CAREONE TAHITIAN COCONUT ETHYL ALCOHOL LIQUID TOPICAL 20140206
mg/mL
41520-401_910f6d88-f1a6-422e-b2b8-7ad8bfc2ba1a 41520-401 HUMAN OTC DRUG
CAREONE TAHITIAN COCONUT ETHYL ALCOHOL LIQUID TOPICAL 20140206
mg/mL
41520-402_0654ab1f-3a2d-4847-b422-7fb397d38691 41520-402 HUMAN OTC DRUG
Care One Cold Head Congestion daytime non-drowsy "Acetaminophen, Dextrome
thorphan Hydrobromide, Phenylephrine Hydrochloride" "TABLET, FILM COATED"
ompany ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORID
E 325; 10; 5 mg/1; mg/1; mg/1
41520-403_72dd82ea-abdc-4af6-bd80-eaaf9316d315 41520-403 HUMAN OTC DRUG
care one pain relief Acetaminophen TABLET ORAL 20040413
mg/1
41520-404_567c9e15-d004-4153-a3c5-49d21b519388 41520-404 HUMAN OTC DRUG
41520-407_4d1ca466-b6db-4257-ae97-8d2e67ac5a88 41520-407 HUMAN OTC DRUG
CareOne Cold Sore Treatment Camphor CREAM TOPICAL 20130417
OTC MONOGRAPH NOT FINAL part348 American Sales Company BENZALKONIUM CHLORIDE; C
AMPHOR (SYNTHETIC) 1.3; 30 mg/g; mg/g
41520-410_3135acba-666a-4faa-8360-0644e15e687d 41520-410 HUMAN OTC DRUG
CAREONE COUNTRY APPLE ETHYL ALCOHOL LIQUID TOPICAL 20140220
mg/mL
41520-410_a5c0ca09-8eb0-456f-92c5-857b95553597 41520-410 HUMAN OTC DRUG
CAREONE COUNTRY APPLE ETHYL ALCOHOL LIQUID TOPICAL 20140206
mg/mL
41520-413_8bfbb5b5-67f5-4a87-a926-10f140353ab5 41520-413 HUMAN OTC DRUG
careone ibuprofen pm "Diphenhydramine citrate, Ibuprofen" "TABLET,
COATED" ORAL 20111208 ANDA ANDA079113 American
Sales Company DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1
41520-416_26300d2c-4a2a-46fa-8391-1213f635fc39 41520-416 HUMAN OTC DRUG
Care One Aspirin Aspirin TABLET ORAL 20040518
41520-418_12b6b69b-0700-413b-aa7e-57858bab2b29 41520-418 HUMAN OTC DRUG
Skin Corrective Innovative Skin Perfector BB Broad Spectrum SPF15 Sunscreen Ligh
t Medium "Titanium Dioxide, Octinoxate" CREAM TOPICAL 20131113
OTC MONOGRAPH NOT FINAL part352 American Sales Company OCTINOXATE; TITANIUM DIO
XIDE 4; 2.1 g/100mL; g/100mL
41520-419_47d7a8bc-415e-40ca-988a-07c90def82dd 41520-419 HUMAN OTC DRUG
careone childrens mucus relief "Dextromethorphan hbr, Guaifenesin"
Sales Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL;
mg/5mL
41520-422_38e9ef32-828f-42dc-b0b0-a02cc3716f72 41520-422 HUMAN OTC DRUG
4 mg/1
41520-423_35bbb6a3-c3bd-4790-91f1-faa0fb759a3e 41520-423 HUMAN OTC DRUG
CAREONE LIME BASIL ETHYL ALCOHOL LIQUID TOPICAL 20140220
mg/mL
41520-423_77e52e54-1da8-46fb-87b5-ccaa0f8062d0 41520-423 HUMAN OTC DRUG
CAREONE LIME BASIL ETHYL ALCOHOL LIQUID TOPICAL 20140220
mg/mL
41520-424_ccb9fea3-1e2d-4146-a108-8dbe72d34312 41520-424 HUMAN OTC DRUG
CAREONE APPLE BERRY ETHYL ALCOHOL LIQUID TOPICAL 20140220
mg/mL
41520-430_96c33f61-82a3-47be-8009-e2b4a8315131 41520-430 HUMAN OTC DRUG
Care One headache relief added strength "Acetaminophen, Aspirin, Caffein
T FINAL part343 American Sales Company ACETAMINOPHEN; ASPIRIN; CAFFEINE
250; 250; 65 mg/1; mg/1; mg/1
41520-431_14803f99-52c7-4324-b64c-971906144739 41520-431 HUMAN OTC DRUG
careone nighttime sleep aid Diphenhydramine Hydrochloride TABLET
ompany DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1
41520-432_e2884730-2d68-452a-8433-335b159617bb 41520-432 HUMAN OTC DRUG
Care One Suphedrine Nasal Decongestant Non Drowsy Pseudoephedrine HCl
part341 American Sales Company PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1
41520-437_5eca3f54-445e-400a-8a85-095c37d28236 41520-437 HUMAN OTC DRUG
care one pain relief pm extra strength "Acetaminophen, Diphenhydramine HCl"
part338 American Sales Company ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
500; 25 mg/1; mg/1
41520-441_13e80c82-b845-4c2e-945d-a0b7473893e6 41520-441 HUMAN OTC DRUG
CARE ONE SLEEP AID Doxylamine succinate TABLET ORAL 20040629
ANDA ANDA040167 American Sales Company DOXYLAMINE SUCCINATE 25
mg/1
41520-442_d2e0ecb2-70e8-4f4b-bcfc-5427278edc31 41520-442 HUMAN OTC DRUG
careone nicotine polacrilex Nicotine polacrilex "GUM, CHEWING"
NICOTINE 4 mg/1
41520-456_33d186c8-508d-4535-9ec6-153efdb1b5d0 41520-456 HUMAN OTC DRUG
2 mg/1
41520-458_aaf2c4cf-43dd-4d28-bc11-dc69559de8a8 41520-458 HUMAN OTC DRUG
CareOne All Day Allergy Cetirizine Hydrochloride TABLET ORAL
20080123 ANDA ANDA078336 American Sales Company CETIRIZI
41520-459_308b961e-91aa-40ad-b8ef-7657d26007fb 41520-459 HUMAN OTC DRUG
CareOne Nitetime Cold Flu Relief "Acetaminophen, Dextromethorphan
L
41520-461_0880a03d-53f6-4e1b-842c-002b2c01ccc3 41520-461 HUMAN OTC DRUG
Care One ibuprofen Ibuprofen "TABLET, CHEWABLE" ORAL
N 100 mg/1
41520-462_373b2274-bbff-429f-b2b7-6b427bc3d03a 41520-462 HUMAN OTC DRUG
careone allergy diphenhydramine HCl CAPSULE ORAL 20040727
OTC MONOGRAPH FINAL part341 American Sales Company DIPHENHYDRAMINE HYDROCHL
ORIDE 25 mg/1
41520-463_2fe993ee-0e79-47cc-9460-5101371d610a 41520-463 HUMAN OTC DRUG
careone allergy relief Chlorpheniramine Maleate TABLET ORAL
CHLORPHENIRAMINE MALEATE 4 mg/1
41520-467_83e673d2-3281-4528-902a-c522086d54d3 41520-467 HUMAN OTC DRUG
care one aspirin Aspirin "TABLET, CHEWABLE" ORAL 20040601
41520-468_1b3c4d55-607f-499c-9ec3-9ce998f5490d 41520-468 HUMAN OTC DRUG
41520-469_8c4193a3-a200-4c78-aafc-7a0b702c09c9 41520-469 HUMAN OTC DRUG
CARE ONE ANTIBACTERIAL RUM RAISIN ETHYL ALCOHOL LIPSTICK
SALES COMPANY ALCOHOL 65 mL/100mL
41520-470_5844de03-3961-49b5-b991-550e4e617390 41520-470 HUMAN OTC DRUG
CARE ONE ANTIBACTERIAL TANGERINE SPICE ETHYL ALCOHOL LIQUID TOPICAL
OMPANY ALCOHOL 650 mg/mL
41520-471_61ba017f-3381-4e42-8374-8e297a6b0ba4 41520-471 HUMAN OTC DRUG
CARE ONE ANTIBACTERIAL SNOW KISSED PEAR ETHYL ALCOHOL LIQUID TOPICAL
41520-472_d3ea9052-d071-485a-8aca-998e42896582 41520-472 HUMAN OTC DRUG
CARE ONE ANTIBACTERIAL PEPPERMINT SWIRL ETHYL ALCOHOL LIQUID TOPICAL
41520-473_1d8c5416-7f2f-4389-b10d-e5e5445b9a1f 41520-473 HUMAN OTC DRUG
DAYTIME cold and flu relief "ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHR
INE HCl" "CAPSULE, LIQUID FILLED" ORAL 20121115
/1; mg/1
41520-474_f30495a7-6931-46ce-b3c6-af50de8352b2 41520-474 HUMAN OTC DRUG
CARE ONE SUN KISSED PEAR ETHYL ALCOHOL LIQUID TOPICAL 20130214
mg/mL
41520-474_f737bfa1-8d06-43ea-883d-57d43f9dfc64 41520-474 HUMAN OTC DRUG
CARE ONE SUN KISSED PEAR ETHYL ALCOHOL LIQUID TOPICAL 20130206
mg/mL
41520-475_90504d49-e099-48f5-8079-c0ac2af40ca6 41520-475 HUMAN OTC DRUG
CARE ONE CREAMY COCONUT ETHYL ALCOHOL LIQUID TOPICAL 20130214
mg/mL
41520-475_93010594-1d5e-4b69-a967-2ac9515ef8a4 41520-475 HUMAN OTC DRUG
CARE ONE CREAMY COCONUT ETHYL ALCOHOL LIQUID TOPICAL 20130206
mg/mL
41520-476_7fdde583-18d4-4971-8737-cdca25bfa8e3 41520-476 HUMAN OTC DRUG
CARE ONE VANILLA APPLE BLOSSOM ETHYL ALCOHOL LIQUID TOPICAL 20130206
mg/mL
41520-476_8d3c522d-d70e-48b2-9579-eecb32251d9d 41520-476 HUMAN OTC DRUG
CARE ONE VANILLA APPLE BLOSSOM ETHYL ALCOHOL LIQUID TOPICAL 20130214
mg/mL
41520-477_886f1706-0f33-4c59-8e66-4faf2d72d79e 41520-477 HUMAN OTC DRUG
care one fiber Calcium polycarbophil "TABLET, FILM COATED" ORAL
CALCIUM POLYCARBOPHIL 625 mg/1
41520-478_418fd8ea-fc26-472c-bc27-eec96465d712 41520-478 HUMAN OTC DRUG
care one calcium antacid calcium carbonate "TABLET, CHEWABL
41520-479_8b9ae1fb-9a3a-460c-88b0-575803eb5648 41520-479 HUMAN OTC DRUG
CARE ONE LEMON VERBENA ETHYL ALCOHOL LIQUID TOPICAL 20130214
mg/mL
41520-484_90f58400-e3be-4fd3-b3a2-f1b78330a1f9 41520-484 HUMAN OTC DRUG
Care One pain relief extra strength Acetaminophen TABLET ORAL 20040413
mg/1
41520-485_85eb5566-5d67-4b4d-99e4-cf564f0c18c7 41520-485 HUMAN OTC DRUG
Care One Calcium Antacid calcium carbonate "TABLET, CHEWABL
41520-489_0e0dad56-f272-498d-8352-0937014faa7e 41520-489 HUMAN OTC DRUG
41520-490_00525800-a7c5-421e-bf50-f8482d1082fe 41520-490 HUMAN OTC DRUG
care one all day pain relief Naproxen Sodium TABLET ORAL 20040504
ANDA ANDA074661 American Sales Company NAPROXEN SODIUM 220 mg/1
41520-496_004ad4e4-b39c-4689-95f5-015d4d955ee9 41520-496 HUMAN OTC DRUG
CARE ONE PUMPKIN PIE ETHYL ALCOHOL LIQUID TOPICAL 20131027
mg/mL
41520-497_6647ccde-389f-4033-bb5d-2710b6004e3b 41520-497 HUMAN OTC DRUG
CARE ONE PEPPERMINT SWIRL ETHYL ALCOHOL LIQUID TOPICAL 20131027
mg/mL
41520-498_91d94af9-ab6a-4e3b-9b6e-8462cbf1ae30 41520-498 HUMAN OTC DRUG
CareOne Mucus ER Guaifenesin "TABLET, EXTENDED RELEASE"
GUAIFENESIN 600 mg/1
41520-499_676285cb-90a5-4431-b8e1-4338ce869093 41520-499 HUMAN OTC DRUG
CARE ONE PINE ETHYL ALCOHOL LIQUID TOPICAL 20131027
mg/mL
41520-500_53852fee-c7cd-46f2-b78a-875e608593fd 41520-500 HUMAN OTC DRUG
CARE ONE VANILLA BEAN ETHYL ALCOHOL LIQUID TOPICAL 20131027
mg/mL
41520-501_ee7e69b9-c9f7-4f49-8e7e-a4d172de3fc7 41520-501 HUMAN OTC DRUG
CAREONE ANTIBACTERIAL HAND SANITIZER PUMPKIN ROLL ETHYL ALCOHOL LIQUID
41520-502_9ed3bc24-3104-4e3f-b3d2-8e780675711b 41520-502 HUMAN OTC DRUG
CAREONE ANTIBACTERIAL HAND SANITIZER FESTIVAL OF LIGHTS ETHYL ALCOHOL LIQUID
41520-503_a1687dcc-957f-4b2c-82f4-4050b3e85780 41520-503 HUMAN OTC DRUG
CAREONE ANTIBACTERIAL HAND SANITIZER WINTER SKY ETHYL ALCOHOL LIQUID TOPICAL
41520-504_b2caf221-2b7b-4b05-bbc3-7372fcd0e565 41520-504 HUMAN OTC DRUG
CAREONE ANTIBACTERIAL HAND SANITIZER SEASONS GREETINGS ETHYL ALCOHOL LIQUID
41520-505_ca3e908a-df71-42cf-a4d1-65b9a6420a93 41520-505 HUMAN OTC DRUG
CareOne Daily Facial "Avobenzone, Octocrylene" CREAM TOPICAL
AVOBENZONE; OCTOCRYLENE 3; 10 mL/100mL; mL/100mL
41520-509_820ec090-0487-4866-bd9f-1839698d82f0 41520-509 HUMAN OTC DRUG
Careone Anti Aging Vitamin Complex 7 in 1 "Avobenzone, Ensulizole, Octisal
ate, Octocrylene" LOTION TOPICAL 20090508 OTC MONOGRAPH NO
T FINAL part352 American Sales Company AVOBENZONE; ENSULIZOLE; OCTISALATE; OCTO
CRYLENE 2; 1; 4; 1 mL/100mL; mL/100mL; mL/100mL; mL/100mL
41520-513_b9692ba4-8ebc-40db-a9e0-87a4369f5fc1 41520-513 HUMAN OTC DRUG
Loratadine Loratadine "TABLET, ORALLY DISINTEGRATING" ORAL
NE 10 mg/1
41520-516_ae4c1a22-5a4e-4088-b8c6-49b4f657e218 41520-516 HUMAN OTC DRUG
CareOne Adult Tussin CF "Dextromethorphan Hydrobromide, Guaifenesin, Phe
nylephrine Hydrochloride" LIQUID ORAL 20060620 OTC MONO
GRAPH FINAL part341 American Sales Company DEXTROMETHORPHAN HYDROBROMIDE; G
UAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/5mL; mg/5mL; mg/5mL
41520-517_acd9cf65-36fc-4587-8a9e-d59597de0925 41520-517 HUMAN OTC DRUG
care one ibuprofen ib Ibuprofen "TABLET, FILM COATED" ORAL
N 200 mg/1
41520-521_34c1079f-3550-4707-8e78-18c0b26b5078 41520-521 HUMAN OTC DRUG
Care One Ibuprofen Junior Strength Ibuprofen "TABLET, CHEWABLE"
IBUPROFEN 100 mg/1
41520-522_334efb13-38cc-4201-86dc-bb75ba5f45a0 41520-522 HUMAN OTC DRUG
Baby Healing Petrolatum OINTMENT TOPICAL 20131113
OTC MONOGRAPH FINAL part347 American Sales Company PETROLATUM 41
g/100g
41520-525_2362edeb-ac77-40c2-a066-757729e41e20 41520-525 HUMAN OTC DRUG
NE 10 mg/1
41520-527_2362edeb-ac77-40c2-a066-757729e41e20 41520-527 HUMAN OTC DRUG
NE 10 mg/1
41520-528_a52f0d20-fe59-48e2-9138-30cbebf322e5 41520-528 HUMAN OTC DRUG
care one calcium antacid CALCIUM CARBONATE "TABLET, CHEWABL
41520-530_e2e1a239-ae03-4bf5-a17d-97075d91d3e1 41520-530 HUMAN OTC DRUG
Acne Wash Oil-Free Salicylic Acid LIQUID TOPICAL 20131115
OTC MONOGRAPH FINAL part333D American Sales Company SALICYLIC ACID
2 g/100mL
41520-531_2ccfe1d7-2250-4212-9345-44ceb105ca56 41520-531 HUMAN OTC DRUG
Redness reliever tetrahydrozoline HCl LIQUID OPHTHALMIC
TETRAHYDROZOLINE HYDROCHLORIDE 0.5 mg/mL
41520-532_a8a645b6-c4f8-4c21-9bbf-661bd417e9de 41520-532 HUMAN OTC DRUG
Advanced relief "dextran 70, polyethylene glycol 400, povidone, tetrahyd
rozoline HCl" LIQUID OPHTHALMIC 20110907 OTC MONOGRAPH FI
NAL part349 American Sales Company DEXTRAN 70; POLYETHYLENE GLYCOL 400; POV
IDONE; TETRAHYDROZOLINE HYDROCHLORIDE 1; 10; 10; .5 mg/mL; mg/mL; mg/mL; mg/
mL
41520-540_33c05a6b-9577-4a1f-951f-d8097809ece1 41520-540 HUMAN OTC DRUG
Baby Care Healing Petrolatum OINTMENT TOPICAL 20131113
g/100g
41520-541_a4f8f2f1-8e6e-4d87-9827-6e3ba14febfb 41520-541 HUMAN OTC DRUG
CareOne Healing Petrolatum OINTMENT TOPICAL 20131115
g/100g
41520-544_af7aafaa-e9e5-4370-bdd6-1069edac9a21 41520-544 HUMAN OTC DRUG
Care One arthritis pain relief temporary minor Acetaminophen "TABLET, FILM CO
American Sales Company ACETAMINOPHEN 650 mg/1
41520-546_554689d9-7bc2-4c15-8304-c86b76dab2b6 41520-546 HUMAN OTC DRUG
care one acid reducer and antacid dual action "Famotidine, Calcium Car
bonate, Magnesium Hydroxide" "TABLET, CHEWABLE" ORAL 20080801
ANDA ANDA077355 American Sales Company CALCIUM CARBONATE; FAMOTIDINE; M
AGNESIUM HYDROXIDE 800; 10; 165 mg/1; mg/1; mg/1
41520-552_d343bbc3-5ffb-4bc9-8426-028b2d826908 41520-552 HUMAN OTC DRUG
care one flu and severe cold daytime "Acetaminophen, Phenylephrine hydrochlor
ide" "POWDER, FOR SUSPENSION" ORAL 20070808 OTC MONO
GRAPH FINAL part341 American Sales Company ACETAMINOPHEN; PHENYLEPHRINE HYD
ROCHLORIDE 650; 10 mg/16000mg; mg/16000mg
41520-571_44a0799b-2615-427e-8cd5-84ccc17d9b0c 41520-571 HUMAN OTC DRUG
care one aller ease fexofenadine hydrochloride "TABLET, FILM CO
ATED" ORAL 20110415 ANDA ANDA076447 American Sales C
ompany FEXOFENADINE HYDROCHLORIDE 180 mg/1
41520-578_0508fd83-4756-4715-aa96-892265275723 41520-578 HUMAN OTC DRUG
CareOne Adult Tussin DM sugar free "Dextromethorphan HBr, Guaifenesin"
SOLUTION ORAL 20040504 OTC MONOGRAPH FINAL part341
American Sales Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200
mg/10mL; mg/10mL
41520-588_08ac52e1-0ece-496b-a0d1-7244f2247396 41520-588 HUMAN OTC DRUG
CareOne Antacid "Aluminum Hydroxide, Magnesium Hydroxide, Simethicone"
Sales Company ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 400; 40;
41520-590_629a3975-fb83-47e9-b76e-33bf2c12c107 41520-590 HUMAN OTC DRUG
careone pain relief acetaminophen SUSPENSION ORAL 20111208
mg/5mL
41520-595_afef7f53-1d54-4270-bdb8-69d12b4d850a 41520-595 HUMAN OTC DRUG
care one calcium antacid Calcium Carbonate "TABLET, CHEWABL
41520-600_368e6d1b-8521-4ca6-9151-e69ea7660b04 41520-600 HUMAN OTC DRUG
Careone ibuprofen junior strength Ibuprofen "TABLET, CHEWABL
E" ORAL 20100521 ANDA ANDA076359 American Sales C
ompany IBUPROFEN 100 mg/1
41520-604_8fe6a0dd-e320-498a-8899-a1df8fda8bdb 41520-604 HUMAN OTC DRUG
care one ibuprofen Ibuprofen TABLET ORAL 20040413
ANDA ANDA072096 American Sales Company IBUPROFEN 200 mg/1
41520-605_1f944136-50ca-4d13-bca2-f9bd96aed2f0 41520-605 HUMAN OTC DRUG
Care One Miconazole 3 Miconazole nitrate KIT 20040727
41520-611_9cf5a337-e1cc-4db7-b8bf-974eb5dad658 41520-611 HUMAN OTC DRUG
Careone Moisturizing Dandruff Selenium Sulfide SHAMPOO TOPICAL 20110819
OTC MONOGRAPH FINAL part358H American Sales Company SELENIUM SULFIDE
1 mL/100mL
41520-612_535f5ae6-b965-4e15-82b3-43813e4c80e4 41520-612 HUMAN OTC DRUG
CareOne Allergy Relief 24 Hour Loratadine TABLET ORAL 20060602
ANDA ANDA076301 American Sales Company LORATADINE 10 mg/1
41520-614_5e3e215b-f997-4366-9bba-42a47bd5e723 41520-614 HUMAN OTC DRUG
MEDICATED DANDRUFF SELENIUM SULFIDE SHAMPOO TOPICAL 20110819
OTC MONOGRAPH FINAL part358H AMERICAN SALES COMPANY SELENIUM SULFIDE
1 mL/100mL
41520-620_60ebdc33-d41d-40d5-a5ba-3cb824115c8d 41520-620 HUMAN OTC DRUG
CARE ONE MEDICATED SELENIUM SULFIDE LIQUID TOPICAL 20130815
10 mg/mL
41520-621_2ac8a2a1-3a9b-4e8d-8124-5f8dd7cfb96c 41520-621 HUMAN OTC DRUG
CARE ONE MOISTURIZING SELENIUM SULFIDE LIQUID TOPICAL 20130715
10 mg/mL
41520-626_17d07bd2-664f-4c67-8c00-0596a2d57ffa 41520-626 HUMAN OTC DRUG
CareOne Daily Moisturizer Broad Spectrum SPF15 Sunscreen "Avobenz
one, Homosalate, Octinoxate, Octocrylene" LOTION TOPICAL 20131115
OTC MONOGRAPH NOT FINAL part352 American Sales Company AVOBENZONE; HOMOSALATE;
OCTINOXATE; OCTOCRYLENE 3; 3; 5; 2.6 g/100mL; g/100mL; g/100mL; g/100mL
41520-645_b8fd34fe-373d-430c-9c0e-d1ad17595232 41520-645 HUMAN OTC DRUG
CareOne loperamide hydrochloride loperamide HCl LIQUID ORAL
20120521 ANDA ANDA091292 American Sales Company LOPERAMI
DE HYDROCHLORIDE 1 mg/7.5mL
41520-647_1710431d-167a-47cd-88cf-0fd93650f845 41520-647 HUMAN OTC DRUG
care one ibuprofen Ibuprofen "TABLET, COATED" ORAL
N 200 mg/1
41520-648_d70dc899-ee4f-4322-aa77-c2861639436f 41520-648 HUMAN OTC DRUG
Care One Nasal Four Phenylephrine hydrochloride SPRAY NASAL
PHENYLEPHRINE HYDROCHLORIDE 1 g/100mL
41520-656_f32be60e-e90a-4bfc-861f-a2831d66b3dd 41520-656 HUMAN OTC DRUG
CareOne Daytime Cold Flu Relief "acetaminophen, dextromethorphan Hbr, Ph
enylephrine HCl" LIQUID ORAL 20130813 OTC MONOGRAPH FI
NAL part341 American Sales Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBRO
L
41520-660_7ceda1fd-6a63-40c0-ba74-d2a202aec7bf 41520-660 HUMAN OTC DRUG
care one ibuprofen childrens Ibuprofen SUSPENSION ORAL
N 100 mg/5mL
41520-666_4f622c86-d8af-4c26-948e-a1cbdb592769 41520-666 HUMAN OTC DRUG
CareOne Cold and Cough "Acetaminophen, Dextromethorphan HBr, Doxylamine
Succinate" LIQUID ORAL 20051028 OTC MONOGRAPH FINAL
part341 American Sales Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DO
XYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL
41520-678_5f249c8a-3541-483a-98b5-483f89a06f3a 41520-678 HUMAN OTC DRUG
CareOne Hemorrhoidal "Mineral oil, petrolatum, phenylephrine hcl"
OINTMENT RECTAL 20121208 OTC MONOGRAPH FINAL part346
American Sales Company MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE
140; 719; 2.5 mg/100g; mg/100g; mg/100g
41520-685_5b20db92-9ed6-402b-9d1f-eb3bf4493a20 41520-685 HUMAN OTC DRUG
Care One ibuprofen childrens Ibuprofen LIQUID ORAL 20080801
ANDA ANDA074937 American Sales Company IBUPROFEN 100 mg/5mL
41520-692_388822eb-6965-4b64-be1d-829346884493 41520-692 HUMAN OTC DRUG
Care One Cool Heat Extra Strength "Menthol, Methyl salicylate" CREAM
ompany MENTHOL; METHYL SALICYLATE 10; 30 g/100g; g/100g
41520-693_489e98bb-ef9e-4da9-a9d6-d6ef78f11b3f 41520-693 HUMAN OTC DRUG
Anti-Aging Vitamin Complex 7-in-1 Broad Spectrum SPF15 Sunscreen
"Avobenzone, Octisalate, Octocrylene" CREAM TOPICAL 20131115
OTC MONOGRAPH NOT FINAL part352 American Sales Company AVOBENZONE; OCTISALATE;
OCTOCRYLENE 3; 5; 8 g/100mL; g/100mL; g/100mL
41520-699_ad36eb7d-358e-4b2c-8e46-faba47edf0be 41520-699 HUMAN OTC DRUG
CareOne Arthritis Pain Relief Capsaicin CREAM TOPICAL 20080718
OTC MONOGRAPH NOT FINAL part348 American Sales Company CAPSAICIN 0.1
g/100g
41520-701_84ed0acf-dcd3-4d4a-8e5c-f75f48993b34 41520-701 HUMAN OTC DRUG
careone nicotine Nicotine Polacrilex LOZENGE ORAL 20060307
ANDA ANDA077007 American Sales Company NICOTINE 2 mg/1
41520-721_abf6717d-19f3-41cc-8ebe-f6109b4ba59f 41520-721 HUMAN OTC DRUG
American Sales Company CareOne Fluoride "PASTE, DENTIFRICE" DENTAL
41520-734_74ec6a60-eb3a-47d4-a11b-650b6418d37f 41520-734 HUMAN OTC DRUG
CareOne Nicotine Nicotine Polacrilex LOZENGE ORAL 20130628
41520-742_4cc2aae9-a7a0-4db6-a4f6-cbd06c07b0a2 41520-742 HUMAN OTC DRUG
careone naproxen sodium Naproxen sodium "CAPSULE, LIQUID FILLED"
ORAL 20111208 NDA NDA021920 American Sales Company
41520-751_b53760e8-4f7b-4a73-9758-b1a1c32053f7 41520-751 HUMAN OTC DRUG
careone pain relief pm "Acetaminophen, Diphenhydramine HCl" "TABLET,
FILM COATED" ORAL 20120203 OTC MONOGRAPH NOT FINAL part343
American Sales Company ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25
mg/1; mg/1
41520-758_8471db91-e87a-4399-a250-276a9f174fbd 41520-758 HUMAN OTC DRUG
CareOne Loperamide Hydrochloride Loperamide Hydrochloride
SUSPENSION ORAL 20140510 ANDA ANDA091292 American
Sales Company LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL
41520-759_72cfdb02-2e32-44e5-b86f-35f147493488 41520-759 HUMAN OTC DRUG
care one pain relief Acetaminophen SUSPENSION ORAL 20110211
mg/5mL
41520-766_1daad7ea-bffa-497e-87c8-4edd682299c0 41520-766 HUMAN OTC DRUG
CareOne Mucus Relief "Acetaminophen, Dextromethorphan HBr, Guaifenesi
n, Phenylephrine HCl" "TABLET, FILM COATED" ORAL 20140730
mg/1; mg/1; mg/1; mg/1
41520-798_a0f5836e-be0d-4f49-9bda-3bf937756156 41520-798 HUMAN OTC DRUG
CareOne Hair Regrowth Treatment Extra Strength Minoxidil SOLUTION
TOPICAL 20091215 ANDA ANDA075598 American Sales Company
MINOXIDIL 3 g/60mL
41520-799_d68afa37-31bc-4725-9381-dad189b6c1dc 41520-799 HUMAN OTC DRUG
CareOne Adult Tussin DM "Dextromethorphan HBr, Guaifenesin" LIQUID
41520-803_ffb6c1e1-44f6-4fc7-9706-f0630a5f02c1 41520-803 HUMAN OTC DRUG
CareOne Pain Relief Pain Relief PM "Acetaminophen, Diphenhydramine
HCl" KIT 20131102 OTC MONOGRAPH NOT FINAL part343
American Sales Company
41520-807_b5e2fd0a-a463-42eb-ba5a-2b8e94426f7f 41520-807 HUMAN OTC DRUG
CAREONE ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20140323
1.5 mg/mL
41520-817_836e7025-5ca6-4534-bb97-015abf8ebeff 41520-817 HUMAN OTC DRUG
care one nasal sinus oxymetazoline hydrochloride SPRAY NASAL 20040524
OTC MONOGRAPH FINAL part341 American Sales Company OXYMETAZOLINE HYDROCHLOR
IDE 0.05 g/100mL
41520-827_7ae805e1-e41e-4414-9a1c-1d55298fca5b 41520-827 HUMAN OTC DRUG
Quick Relief Creamy Diaper Rash Zinc Oxide CREAM TOPICAL 20131115
OTC MONOGRAPH FINAL part347 American Sales Company ZINC OXIDE 130
mg/g
41520-829_6f3c22a6-8d96-42b3-9275-7fa8dcf85fda 41520-829 HUMAN OTC DRUG
"CAPSULE, COATED" ORAL 20100903 OTC MONOGRAPH FINAL
500; 25 mg/1; mg/1
41520-837_25afd5d8-ac9f-4903-bc6a-ad719abd3e44 41520-837 HUMAN OTC DRUG
500; 25 mg/1; mg/1
41520-839_a85d234a-9955-46a4-8120-c1a16afdd6ff 41520-839 HUMAN OTC DRUG
CareOne Childrens Mucus Relief "dextromethorphan HBr, guaifenesin, phen
ylephrine HCl" SOLUTION ORAL 20140805 OTC MONOGRAPH FI
NAL part341 American Sales Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENES
IN; PHENYLEPHRINE HYDROCHLORIDE 5; 100; 2.5 mg/5mL; mg/5mL; mg/5mL
41520-851_687bd050-fba8-44cf-9a72-19c441d6423f 41520-851 HUMAN OTC DRUG
Careone antacid "Aluminum hydroxide, Magnesium hydroxide, Simethicone"
Sales Company ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20;
41520-852_517ccdae-a872-4bb2-ba78-645ffafabc50 41520-852 HUMAN OTC DRUG
careone acid reducer Ranitidine "TABLET, FILM COATED" ORAL
20131130 ANDA ANDA091429 American Sales Company RANITIDI
41520-854_826bcacf-d678-4564-8052-123fbb7528d6 41520-854 HUMAN OTC DRUG
Care One Nicotine Nicotine polacrilex "GUM, CHEWING" ORAL
4 mg/1
41520-863_9c1c705f-deab-4b86-8671-0e50174bd027 41520-863 HUMAN OTC DRUG
CARE ONE COOL HEAT PAIN RELIEVING "MENTHOL, METHYL SALICYLATE"
CREAM TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part348 AMERICAN
SALES COMPANY MENTHOL; METHYL SALICYLATE 10; 30 g/100g; g/100g
41520-865_f76f2e3a-d8b4-4ee3-a1c4-89b79939b3d9 41520-865 HUMAN OTC DRUG
Artificial Tears "glycerin, hypromellose, polyethylene glycol 400
" LIQUID OPHTHALMIC 20100906 OTC MONOGRAPH FINAL
part349 American Sales Company GLYCERIN; HYPROMELLOSES; POLYETHYLENE GLYCOL 400
41520-866_7ef839fb-ff01-41df-84c0-aa5263412dc5 41520-866 HUMAN OTC DRUG
care one lice killing "Piperonyl butoxide, Pyrethrum extract" SHAMPOO
TOPICAL 20070829 OTC MONOGRAPH FINAL part358G American
Sales Company PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 g/100mL; g/100mL
41520-869_61a4691e-e9ae-4d8b-91c2-f6cebef0f30a 41520-869 HUMAN OTC DRUG
CareOne 7-in-1 Anti-Aging Vitamin "Avobenzone, Octisalate and Octo
crylene" CREAM TOPICAL 20120511 OTC MONOGRAPH NOT FINAL
part352 American Sales Company AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 5; 8
41520-871_957e7111-342c-4605-91bf-399a02205eb0 41520-871 HUMAN OTC DRUG
Careone Extra Strength Cold and Hot Menthol PATCH TOPICAL 20140616
OTC MONOGRAPH NOT FINAL part348 American Sales Company MENTHOL 0.05 mg/1
41520-873_f914bb8c-e64f-4261-a2cc-bda3a286d206 41520-873 HUMAN OTC DRUG
care one nicotine Nicotine Polacrilex LOZENGE ORAL 20060307
41520-878_51970119-d31b-482c-98cc-d651f003f3f1 41520-878 HUMAN OTC DRUG
PEANUTS ANTI-CAVITY FLUORIDE TOOTHPASTE SODIUM FLUORIDE PASTE DENTAL
41520-886_55edc748-5c76-4e6f-aded-feb55de7b8f2 41520-886 HUMAN OTC DRUG
care one sinus "Acetaminophen, Chlorpheniramine maleate, Phenylephrine
HCl" KIT 20070822 OTC MONOGRAPH FINAL part341
41520-886_a72ec52b-b32a-4b44-ba34-1a257d3fa3a5 41520-886 HUMAN OTC DRUG
careone sinus congestion and pain daytime nighttime "Acetaminophen,P
henylephrine HCl, Chlorpheniramine maleate" KIT 20110916
41520-896_6c6722be-b045-4ea5-97b4-a97d1a902429 41520-896 HUMAN OTC DRUG
CareOne Lubricant "Polyethylene glycol, Propylene glycol" "SOLUTIO
N, GEL FORMING / DROPS" OPHTHALMIC 20130709 OTC MONOGRAPH FI
NAL part349 American Sales Company POLYETHYLENE GLYCOL 400; PROPYLENE GLYCO
L .4; .3 g/100mL; g/100mL
41520-897_9112a443-4fd1-48c3-9d88-86136ac60726 41520-897 HUMAN OTC DRUG
care one ibuprofen Ibuprofen SUSPENSION ORAL 20040428
ANDA ANDA074937 American Sales Company IBUPROFEN 100 mg/5mL
41520-906_0a042307-6e7e-46b0-96d6-08d33a155e54 41520-906 HUMAN OTC DRUG
CareOne Childrens Cold and Allergy "phenylephrine hcl, brompheniram
ine maleate" LIQUID ORAL 20060907 OTC MONOGRAPH FINAL
part341 American Sales Company BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLO
RIDE 1; 2.5 mg/5mL; mg/5mL
41520-911_d3d1ae52-fd05-4ab9-8aab-db6d86eab410 41520-911 HUMAN OTC DRUG
Medicated Pain Relief Menthol PATCH TOPICAL 20110916
OTC MONOGRAPH NOT FINAL part348 American Sales Company MENTHOL 428.5 mg/1
41520-913_76fc34c5-0adc-4565-8d47-ef1ef4b0368b 41520-913 HUMAN OTC DRUG
CareOne Triacting Night Time Cold and Cough Childrens "Diphenhydramine
HCl, Phenylephrine HCl" LIQUID ORAL 20090605 OTC MONO
GRAPH FINAL part341 American Sales Company DIPHENHYDRAMINE HYDROCHLORIDE; P
HENYLEPHRINE HYDROCHLORIDE 6.25; 2.5 mg/5mL; mg/5mL
41520-915_04ef5af8-480f-478e-af84-730cc2635a50 41520-915 HUMAN OTC DRUG
care one omeprazole Omeprazole "TABLET, DELAYED RELEASE"
ORAL 20080229 NDA NDA022032 American Sales Company
OMEPRAZOLE 20 mg/1
41520-916_bf7391ef-bcca-45c6-882f-033fd7970596 41520-916 HUMAN OTC DRUG
care one miconazole 1 Miconazole nitrate KIT 20101119
41520-917_c09ad598-3e70-488d-9aaa-fa6dcf0247b7 41520-917 HUMAN OTC DRUG
Care One Pain Relief extra strength Acetaminophen "CAPSULE, COATED"
41520-922_6b78bbd4-b9ee-4de5-845e-a3fe08f87016 41520-922 HUMAN OTC DRUG
CareOne Mucus Relief Severe Congestion and Cold "Acetaminophen, Dextrome
thorphan HBr, Guaifenesin, Phenylephrine HCl" "TABLET, FILM COATED" ORAL
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCH
LORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1
41520-923_feec6b2b-3459-4dfc-b569-6f45f84642e9 41520-923 HUMAN OTC DRUG
care one eye itch relief Ketotifen Fumarate SOLUTION
OPHTHALMIC 20100830 ANDA ANDA077958 American Sales C
ompany KETOTIFEN FUMARATE 0.25 mg/mL
41520-927_cd539300-2278-45c6-bcd3-8282cd850ca7 41520-927 HUMAN OTC DRUG
Maximum Strength Original Diaper Rash Zinc Oxide CREAM TOPICAL
ZINC OXIDE 400 mg/g
41520-941_454662f8-b269-4d9d-810c-160c4a8d2486 41520-941 HUMAN OTC DRUG
CAREONE LEMON ETHYL ALCOHOL LIQUID TOPICAL 20140126 OTC MONO
GRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 700 mg/mL
41520-946_442019f1-4c62-453d-89c3-c7600411d6b9 41520-946 HUMAN OTC DRUG
careone pain relief infants Acetaminophen SUSPENSION ORAL 20110902
mg/5mL
41520-949_5e862cdc-4acb-4dbb-a33b-d6ea8c6ec8aa 41520-949 HUMAN OTC DRUG
41520-950_921710e8-7761-4c68-bbe2-d547c898f714 41520-950 HUMAN OTC DRUG
CareOne Acid Reducer Ranitidine "TABLET, FILM COATED" ORAL
20130922 ANDA ANDA091429 American Sales Company RANITIDI
41520-957_d3591f0c-f638-485a-ab34-f71fce6a966f 41520-957 HUMAN OTC DRUG
CareOne Mini Nicotine Polacrilex Nicotine Polacrilex LOZENGE
NICOTINE 4 mg/1
41520-958_42f67a3c-8cd7-44a6-8e54-08fb8449e8d7 41520-958 HUMAN OTC DRUG
CareOne Cough DM dextromethorphan polistirex SUSPENSION
DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL
41520-959_a85fac16-5351-45de-aa05-848603f9fa66 41520-959 HUMAN OTC DRUG
careone childrens pain and fever Acetaminophen SUSPENSION
41520-960_52bcbc35-0b39-4f63-9583-038caced2976 41520-960 HUMAN OTC DRUG
care one anti diarrheal Loperamide HCl "TABLET, FILM COATED" ORAL
20040123 ANDA ANDA075232 American Sales Company LOPERAMI
DE HYDROCHLORIDE 2 mg/1
41520-964_10b1b0fb-dcbf-4586-8f14-88df5b11e5a0 41520-964 HUMAN OTC DRUG
care one flu and severe cold and cough nighttime "Acetaminophen, Diphenhy
dramine hydrochloride, Phenylephrine hydrochloride" "POWDER, FOR SOLUTION"
ompany ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORID
E 650; 25; 10 mg/1; mg/1; mg/1
41520-966_aef4fb40-0c1f-442d-9291-d06b024ce4c8 41520-966 HUMAN OTC DRUG
care one arthritis pain relief Acetaminophen "TABLET, FILM COATED, EX
Sales Company ACETAMINOPHEN 650 mg/1
41520-969_a500406f-8658-469c-90b2-ccab159db5bc 41520-969 HUMAN OTC DRUG
Care One Pain Relief and Pain Relief PM "Acetaminophen, Diphenhydramine
HCl" KIT 20060930 OTC MONOGRAPH FINAL part338
41520-973_c53bacee-c55e-4cb1-9ac0-7f4c81b88cdf 41520-973 HUMAN OTC DRUG
care one hydrocortisone maximum strength hydrocortisone CREAM TOPICAL
41520-974_bb96a5aa-fdf9-4667-8261-5bc88216df29 41520-974 HUMAN OTC DRUG
CareOne All Day Allergy Childrens Cetirizine Hydrochloride LIQUID
CETIRIZINE HYDROCHLORIDE 5 mg/5mL
41520-975_448356cb-7794-450b-8810-272489e6981e 41520-975 HUMAN OTC DRUG
Care One Medicated Lip Balm Petrolatum STICK TOPICAL 20130311
mg/g
41520-976_0c9d4c39-a4ba-41d6-80f5-93bf38961de4 41520-976 HUMAN OTC DRUG
Care One Medicated Lip Balm in a Pot Petrolatum OINTMENT
TOPICAL 20130312 OTC MONOGRAPH FINAL part347 American Sales C
ompany PETROLATUM 43.75 mg/g
41520-977_de0225a7-cf38-488e-8085-81d27f354b71 41520-977 HUMAN OTC DRUG
Care One Moisture SPF 15 Lip Balm "Oxybenzone, Octinoxate, Petrola
tum" STICK TOPICAL 20130315 OTC MONOGRAPH FINAL part352
American Sales Company OCTINOXATE; OXYBENZONE; PETROLATUM 7.5; 3.5; 40.7
mg/g; mg/g; mg/g
41520-978_c8d6a93f-942b-4441-909c-0325bcbec4f5 41520-978 HUMAN OTC DRUG
Care One Cherry SPF 4 Lip Balm "Padimate O, Petrolatum" STICK
TOPICAL 20130315 OTC MONOGRAPH FINAL part352 American Sales C
ompany PADIMATE O; PETROLATUM 1.5; 44 mg/g; mg/g
41520-979_dd6e8327-896a-4479-ae40-41201d78f1f2 41520-979 HUMAN OTC DRUG
Care One Original SPF 4 Lip Balm "Padimate O, Petrolatum"
STICK TOPICAL 20130315 OTC MONOGRAPH FINAL part352 American
Sales Company PADIMATE O; PETROLATUM 1.5; 44 mg/g; mg/g
41520-980_c005330b-5cb0-48d6-9d24-634d5ecd7722 41520-980 HUMAN OTC DRUG
Care One Pain Relief Acetaminophen SUSPENSION/ DROPS ORAL
41520-981_682f31ff-0569-4683-8b8e-91b9476ee2fb 41520-981 HUMAN OTC DRUG
care one cold head congestion "Acetaminophen, Chlorpheniramine maleate
41520-987_cce5ba29-d529-4fe1-8ab9-fc5bcd5d4d14 41520-987 HUMAN OTC DRUG
CareOne Childrens Cold and Cough "Brompheniramine maleate, Dextro
methorphan HBr, Phenylephrine HCl" LIQUID ORAL 20060907
OTC MONOGRAPH FINAL part341 American Sales Company BROMPHENIRAMINE MALEATE;
41520-995_df51c4c8-14f5-43b4-b156-cc5a1f9dcf97 41520-995 HUMAN OTC DRUG
CareOne NiteTime Cough "Dextromethorphan HBr, Doxylamine succinate"
Sales Company DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5
mg/30mL; mg/30mL
41520-809_3896ae05-3434-45c0-93d8-42cf234fd7af 41520-809 HUMAN OTC DRUG
Alcohol Isopropyl Alcohol SWAB TOPICAL 20110408
OTC MONOGRAPH NOT FINAL part333A "American Sales Company, Inc." ISOPROPY
L ALCOHOL 70 mL/100mL
68754-150_50092344-ecd8-4da4-aa57-3132bbb8c8a8 68754-150 HUMAN OTC DRUG
Medicated Anti-Fungal Miconazole Miconazole Nitrate LIQUID
TOPICAL 20100602 OTC MONOGRAPH FINAL part333 "American Sprayt
ech, LLC" MICONAZOLE NITRATE 2 g/100g
11331-001_0e929bcb-6da3-4dbe-a169-5c12c08d0b27 11331-001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS American Welding & Gas OXYGEN 99 L/100L
44076-006_0ac204bb-b882-4e72-a5d0-9d72c10ad470 44076-006 HUMAN PRESCRIPTI
20070401 NDA NDA205839 American Welding & Gas NITROGEN
990 mL/L
44076-010_fecbf19f-539f-4fee-87d6-bc9cad920ef6 44076-010 HUMAN PRESCRIPTI
NDA NDA205840 American Welding & Gas OXYGEN 990 mL/L
44076-012_2b3a2d59-fd5f-409f-8864-8cf8d0d76a5b 44076-012 HUMAN PRESCRIPTI
20140501 NDA NDA205704 American Welding & Gas NITROUS
OXIDE 990 mL/L
49778-001_ff818ac6-b10e-4b24-b435-f2a75f290f89 49778-001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS American Welding & Gas OXYGEN 992 mL/1000m
L
49778-002_11ca393a-47aa-4ee5-8d3b-61d818bdfe63 49778-002 HUMAN PRESCRIPTI
49778-003_cb6fda01-23d6-4358-8bc8-37495c829949 49778-003 HUMAN PRESCRIPTI
20090501 UNAPPROVED MEDICAL GAS American Welding & Gas
NITROGEN 99 mL/100mL
49778-004_f4577f6b-6e29-4299-83e9-d02133ce44b8 49778-004 HUMAN PRESCRIPTI
NITROGEN 99 L/100L
49778-005_8f3fc95a-ae07-4d4e-b6e3-5309101a857b 49778-005 HUMAN PRESCRIPTI
55749-002_d0381ff5-ae2e-489e-8b38-69152670b3a4 55749-002 HUMAN PRESCRIPTI
55749-004_5c38c3d2-3639-493a-ac5a-22ec4d6e8c3a 55749-004 HUMAN PRESCRIPTI
ON DRUG Nitrogen Nirtogen GAS RESPIRATORY (INHALATION)
NITROGEN 99 L/100L
55749-005_ea7dd69a-e999-40e3-a59c-dab376c10de3 55749-005 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS American Welding & Gas OXYGEN 195 mL/1000m
L
10675-002_3f08b518-8975-4eeb-aad6-49c0948fff89 10675-002 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS "America's Healthcare At Home, Inc." OXYGEN
99 L/100L
61504-000_37906041-267e-42d6-947a-f4ee52cb50bb 61504-000 HUMAN OTC DRUG
Iris Antimicrobial Hand CHLOROXYLENOL SOAP TOPICAL 20131218
OTC MONOGRAPH NOT FINAL part333A Amerifoods Trading Company CHLOROXY
LENOL 3 mg/mL
61504-001_ae6cc4b7-ea7d-42b8-b84b-26efd4134e82 61504-001 HUMAN OTC DRUG
Iris Antimicrobial Hand CHLOROXYLENOL SOAP TOPICAL 20131218
OTC MONOGRAPH NOT FINAL part333A Amerifoods Trading Company CHLOROXY
LENOL 3 mg/mL
61504-002_107f938c-d831-46aa-bcfe-19e5c2465c61 61504-002 HUMAN OTC DRUG
First Street Dishwasing Concentrate and Antimicrobial Hand CHLOROXY
LENOL SOAP TOPICAL 20131218 OTC MONOGRAPH NOT FINAL part333A
Amerifoods Trading Company CHLOROXYLENOL 3 mg/mL
43975-220_c94d8749-b1fc-4b8d-b2aa-4d063f573254 43975-220 HUMAN PRESCRIPTI
ON DRUG Carbidopa Carbidopa TABLET ORAL 20131101
ANDA ANDA203261 Amerigen Pharmaceuticals Inc. CARBIDOPA 25
mg/1
68084-216_82a2043b-6287-462d-a7a8-0b177ffdb173 68084-216 HUMAN PRESCRIPTI
ANDA ANDA070035 Amerincan Health Packaging METRONIDAZOLE 250
]"
68084-364_82a2043b-6287-462d-a7a8-0b177ffdb173 68084-364 HUMAN PRESCRIPTI
ANDA ANDA070044 Amerincan Health Packaging METRONIDAZOLE 500
]"
60555-622_5dd309f5-5c0d-49d1-a6e0-0bba7eb4bbc0 60555-622 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS "Ameri-Quipt of North Carolina, Inc" OXYGEN
99 L/100L
46122-043_1e91a32c-524e-44ab-9553-b3e761dc3944 46122-043 HUMAN OTC DRUG
Good Neighbor Pharmacy Alcohol Antiseptic Skin Cleanser Isopropyl Alcoho
l SWAB TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part333A
Amerisouce Bergen ISOPROPYL ALCOHOL 70 mL/100mL
24385-001_56dd4269-4c74-4815-927d-1ee4b38f59f7 24385-001 HUMAN OTC DRUG
good neighbor pharmacy 8 hour pain relief Acetaminophen "TABLET,
77 Amerisource Bergen ACETAMINOPHEN 650 mg/1
24385-005_068cab9b-3f47-48c8-b5f9-914a63a473b7 24385-005 HUMAN OTC DRUG
Good Neighbor Pharmacy Day Time "acetaminophen, dextromethorphan Hbr, Ph
enylephrine HCl" LIQUID ORAL 20060720 OTC MONOGRAPH FI
NAL part341 Amerisource Bergen ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBRO
L
24385-009_3479ba9d-99ed-4a4c-8c13-66c341a77a89 24385-009 HUMAN OTC DRUG
Good Neighbor Pharmacy ibuprofen childrens Ibuprofen LIQUID
ORAL 19940809 ANDA ANDA074937 Amerisource Bergen
24385-011_f130ce02-1f83-4eec-9487-bbd2b8195740 24385-011 HUMAN OTC DRUG
Good Neighbor pharmacy muscle rub "Menthol, Methyl salicylate"
CREAM TOPICAL 20060117 OTC MONOGRAPH NOT FINAL part348 Amerisou
rce Bergen MENTHOL; METHYL SALICYLATE 10; 15 g/100g; g/100g
24385-028_b6b01b95-6003-4c9d-a7c0-01dc0fc6ad7c 24385-028 HUMAN OTC DRUG
Good Neighbor Pharmacy Aspirin Aspirin "TABLET, CHEWABLE" ORAL
19930319 OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen
ASPIRIN 81 mg/1
24385-032_bd8164cd-c58f-4f72-99a2-5fdb797521a7 24385-032 HUMAN OTC DRUG
Tolnaftate Antifungal Tolnaftate CREAM TOPICAL 20060217
OTC MONOGRAPH FINAL part333C Amerisource Bergen TOLNAFTATE
10 mg/g
24385-035_a77f3142-3ec0-4037-b134-a4f2261aed21 24385-035 HUMAN OTC DRUG
good neighbor pharmacy night time "Acetaminophen, Dextromethorphan
HBr, Doxylamine Succinate" "CAPSULE, LIQUID FILLED" ORAL 20060419
OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; DEXTROMET
24385-036_e5c1bd96-d27d-49c1-b3b8-eee53a145ef5 24385-036 HUMAN OTC DRUG
good neighbor pharmacy day time cold and flu "Acetaminophen, Dextromethorphan
HBr, Phenylephrine HCl" "CAPSULE, LIQUID FILLED" ORAL 20120802
/1; mg/1
24385-039_ac9975a9-2b59-440f-a8d7-cad5dc9cf016 24385-039 HUMAN OTC DRUG
good neighbor pharmacy enema Saline ENEMA RECTAL 20091124
OTC MONOGRAPH NOT FINAL part334 Amerisource Bergen "SODIUM PHOSPHATE, DIBAS
24385-052_828faf61-2440-46ec-bdff-85f08c3a64c9 24385-052 HUMAN OTC DRUG
Good Neighbor Pharmacy Cold "Acetaminophen, Dextromethorphan Hydrobr
omide, Phenylephrine Hydrochloride" TABLET ORAL 20080923
/1; mg/1
24385-053_49b195d0-00fe-4ea7-9483-0e71f8e9b8b4 24385-053 HUMAN OTC DRUG
Povidone Iodine povidone-iodine SOLUTION TOPICAL 20050201
OTC MONOGRAPH NOT FINAL part333A Amerisource Bergen POVIDONE-IODINE
0.1 mg/mL
24385-054_d84a0c76-ad50-4616-9252-84ca25a19ca0 24385-054 HUMAN OTC DRUG
good neighbor pharmacy nasal decongestant Pseudoephedrine Hydrochl
oride "TABLET, FILM COATED, EXTENDED RELEASE" ORAL 19990812
ANDA ANDA075153 Amerisource Bergen PSEUDOEPHEDRINE HYDROCHLORIDE
120 mg/1
24385-058_2e29b4cb-ffab-436e-b3af-fc0ee7db8c52 24385-058 HUMAN OTC DRUG
Good Neighbor Pharmacy ibuprofen Ibuprofen "TABLET, FILM CO
ATED" ORAL 20060614 ANDA ANDA077349 Amerisource Berg
en IBUPROFEN 200 mg/1
24385-059_f6890378-0271-40ec-8556-4dc62dd32dd8 24385-059 HUMAN OTC DRUG
Good Neighbor Pharmacy ibuprofen Ibuprofen "TABLET, COATED"
IBUPROFEN 200 mg/1
24385-061_ede880b7-0712-4041-a713-d0c62bc39a86 24385-061 HUMAN OTC DRUG
good neighbor pharmacy triple antibiotic "bacitracin, neomycin, p
NAL part333 Amerisource Bergen BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN
B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g
24385-065_06c72836-e1f8-4432-914b-7756e1858aeb 24385-065 HUMAN OTC DRUG
Alcohol Pad isopropyl alcohol SWAB TOPICAL 19950801
OTC MONOGRAPH NOT FINAL part333E Amerisource Bergen ISOPROPYL ALCOHO
L 0.7 mL/1
24385-066_34de34ae-1036-4652-bc3d-b922dc5a283e 24385-066 HUMAN OTC DRUG
good neighbor pharmacy cold multi symptom "Acetaminophen, Dextromethorphan
ATED" ORAL 19930330 OTC MONOGRAPH FINAL part341 Amerisou
rce Bergen ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENY
24385-067_378d2bfc-707e-404d-a94f-2b49f5077cff 24385-067 HUMAN OTC DRUG
good neighbor pharmacy nasal extra moisturizing Oxymetazoline HCl
SPRAY NASAL 19950504 OTC MONOGRAPH FINAL part341 Amerisou
rce Bergen OXYMETAZOLINE HYDROCHLORIDE 0.05 g/100mL
24385-070_7b22d6ee-ff45-42b2-96c0-e86718595506 24385-070 HUMAN OTC DRUG
Good Neighbor Pharmacy Vitamin A and D "Lanolin, Petrolatum" OINTMENT
TOPICAL 20050823 OTC MONOGRAPH FINAL part347 Amerisource Berg
en LANOLIN; PETROLATUM 15.5; 53.4 g/100g; g/100g
24385-072_d89008cc-2242-436c-bb1c-865febae8091 24385-072 HUMAN OTC DRUG
GNP Caldyphen Calamine and Pramoxine Hydrochloride LOTION TOPICAL
20080101 OTC MONOGRAPH FINAL part347 Amerisource Bergen
PRAMOXINE HYDROCHLORIDE; ZINC OXIDE 10; 80 mg/mL; mg/mL
24385-076_cd6f6641-99a7-4cd6-bc38-d2f91b02fc4e 24385-076 HUMAN OTC DRUG
good neighbor pharmacy cold "Acetaminophen, Chlorpheniramine Maleate
rce Bergen ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROB
24385-088_a674294f-c7c1-453d-8151-1615bd298904 24385-088 HUMAN OTC DRUG
good neighbor pharmacy sinus congestion and pain "Acetaminophen, Chlorphe
niramine maleate, Phenylephrine HCl" TABLET ORAL 20080825
OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; CHLORPHEN
IRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1
24385-105_5f283c13-fe33-4830-af04-b48f7e768891 24385-105 HUMAN OTC DRUG
good neighbor pharmacy pain relief childrens Acetaminophen SUSPENSI
ON ORAL 19980312 OTC MONOGRAPH NOT FINAL part343 Amerisou
rce Bergen ACETAMINOPHEN 160 mg/5mL
24385-111_ba74fadd-acd1-432a-956a-0e906512e240 24385-111 HUMAN OTC DRUG
Good Neighbor Pharmacy Heartburn Relief Cimetidine TABLET ORAL
20000105 ANDA ANDA075285 Amerisource Bergen CIMETIDI
NE 200 mg/1
24385-116_8105e191-1118-4d91-b168-fc42aaa9af47 24385-116 HUMAN OTC DRUG
good neighbor pharmacy Lice "Piperonyl butoxide, Pyrethrum extract"
SHAMPOO TOPICAL 20070731 OTC MONOGRAPH FINAL part358G
Amerisource Bergen PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 mL/100mL
; mL/100mL
24385-130_fbe8235d-3e79-4dd4-8991-2ffc42445f09 24385-130 HUMAN OTC DRUG
24385-133_11dcfcb3-ae62-4fd7-a1c7-d211e8c6038c 24385-133 HUMAN OTC DRUG
Soothing Bath Treatment Colloidal Oatmeal POWDER TOPICAL 19941001
OTC MONOGRAPH FINAL part347 Amerisource Bergen OATMEAL 1 g/g
24385-135_79e5c7de-6967-41fd-84a2-d1897d436e00 24385-135 HUMAN OTC DRUG
good neighbor pharmacy cough and sore throat "Acetaminophen, Dextrome
thorphan HBr, Doxylamine Succinate" LIQUID ORAL 20060214
; mg/15mL
24385-141_09ff2eb2-7d4a-468c-8cb1-ffeff0754c97 24385-141 HUMAN OTC DRUG
Good Neighbor Pharmacy Muscle Rub Ultra Strength "Camphor, Menthol, Methy
l Salicylate" CREAM TOPICAL 20050802 OTC MONOGRAPH NOT FINAL
part348 Amerisource Bergen CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE
4; 10; 30 g/100g; g/100g; g/100g
24385-143_53270d3d-2d3d-4779-9dd5-54766406de05 24385-143 HUMAN OTC DRUG
Good Neighbor Pharmacy Triple Antibiotic Plus Pain Relief "Bacitracin zinc
, Neomycin sulfate, Polymyxin B sulfate, and Pramoxine hydrochloride" OINTMENT
TOPICAL 20120331 OTC MONOGRAPH FINAL part333B Amerisou
rce Bergen BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXIN
E HYDROCHLORIDE 500; 3.5; 10000; 10 [iU]/g; mg/g; [iU]/g; mg/g
24385-145_b876ffee-200c-4100-a72f-23d98ee5cc3e 24385-145 HUMAN OTC DRUG
good neighbor pharmacy pain relief extra strength Acetaminophen "TABLET,
FILM COATED" ORAL 20060105 OTC MONOGRAPH NOT FINAL part343
Amerisource Bergen ACETAMINOPHEN 500 mg/1
24385-146_c7d2fe61-f759-4de0-be63-0222e32ea899 24385-146 HUMAN OTC DRUG
24385-147_f9b73b21-6936-4354-97f2-59f5401b450e 24385-147 HUMAN OTC DRUG
good neighbor pharmacy allergy multi symptom "Acetaminophen, Chlorpheniramine
maleate, Phenylephrine HCl" TABLET ORAL 20061212 OTC MONO
GRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; CHLORPHENIRAMINE
MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1
24385-165_ec1ca0fa-5325-41be-a4fb-101cef5abdb5 24385-165 HUMAN OTC DRUG
good neighbor pharmacy arthritis pain Trolamine Salicylate CREAM
TOPICAL 19900215 OTC MONOGRAPH NOT FINAL part348 Amerisource Berg
en TROLAMINE SALICYLATE 10 g/100g
24385-169_fe2205b7-c0fc-4fc8-9dda-497dd7ec10f2 24385-169 HUMAN OTC DRUG
good neighbor pharmacy sinus congestion and pain "Acetaminophen, Phenylep
hrine HCl" "TABLET, FILM COATED" ORAL 20061227 OTC MONO
GRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; PHENYLEPHRINE HYD
ROCHLORIDE 325; 5 mg/1; mg/1
24385-170_31a14b4d-86cc-409c-9eb4-aca6653917f9 24385-170 HUMAN OTC DRUG
good neighbor pharmacy nicotine Nicotine Polacrilex "GUM, CHEWING"
NICOTINE 2 mg/1
24385-171_eaa70a28-26db-4891-8917-4309e932236a 24385-171 HUMAN OTC DRUG
Good Neighbor Pharmacy Nicotine Nicotine Polacrilex "GUM, CHEWING"
NICOTINE 4 mg/1
24385-175_c2054637-65b4-4944-9fe8-253965c19b9a 24385-175 HUMAN OTC DRUG
Good Neighbor Pharmacy All Day Allergy D "Cetirizine HCl, Pseudoe
phedrine HCl" "TABLET, EXTENDED RELEASE" ORAL 20080506
ANDA ANDA077170 Amerisource Bergen CETIRIZINE HYDROCHLORIDE; PSEUDO
EPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1
24385-183_6cfba0e9-731b-4a34-b4ab-ee91ec6e9e20 24385-183 HUMAN OTC DRUG
Good Neighbor Pharmacy Dayhist Allergy Clemastine fumarate TABLET
CLEMASTINE FUMARATE 1.34 mg/1
24385-188_987558e7-1659-45ec-ae8c-1ce52a60ae33 24385-188 HUMAN OTC DRUG
good neighbor pharmacy all day allergy cetirizine hydrochloride
LIQUID ORAL 20080422 ANDA ANDA090254 Amerisource Berg
en CETIRIZINE HYDROCHLORIDE 5 mg/5mL
24385-195_67c337e2-8bdb-4684-a67f-99b7993a84f0 24385-195 HUMAN OTC DRUG
good neighbor pharmacy cold head congestion "Acetaminophen, Chlorphe
niramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride"
part341 Amerisource Bergen ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROM
ETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg
/1; mg/1; mg/1
24385-197_4fadfe7f-d069-4c1d-9df4-622d09484f47 24385-197 HUMAN OTC DRUG
Good Neighbor Pharmacy Cold Head Congestion "Acetaminophen, Dextromethorphan
Hydrobromide, Phenylephrine Hydrochloride" "TABLET, FILM COATED" ORAL
325; 10; 5 mg/1; mg/1; mg/1
24385-200_6d97c9b1-3107-4ef2-b738-1d4c6c21c63b 24385-200 HUMAN OTC DRUG
Hygienic Cleansing Pads witch hazel SOLUTION RECTAL; TOPICAL
WITCH HAZEL 0.5 mL/mL
24385-201_fdf66de5-7d61-4908-ac96-7625c575dbe8 24385-201 HUMAN OTC DRUG
good neighbor pharmacy complete "famotidine, calcium carbonate and magne
sium hydroxide" "TABLET, CHEWABLE" ORAL 20080804 ANDA
ANDA077355 Amerisource Bergen CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM
HYDROXIDE 800; 10; 165 mg/1; mg/1; mg/1
24385-202_484dfa69-e62e-477c-98fe-0b5a1010c0c5 24385-202 HUMAN OTC DRUG
good neighbor pharmacy complete "Famotidine, Calcium Carbonate, Magnesiu
m Hydroxide" "TABLET, CHEWABLE" ORAL 20080804 ANDA
ANDA077355 Amerisource Bergen CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM
HYDROXIDE 800; 10; 165 mg/1; mg/1; mg/1
24385-203_e22bab9f-0cee-42b5-9fa9-3fca416de041 24385-203 HUMAN OTC DRUG
good neighbor pharmacy Night time "acetaminophen, dextromethorphan
hydrobromide and doxylamine succinate" LIQUID ORAL 20060523
; mg/15mL
24385-210_a077ddc0-abcb-45ef-8652-65429fda89a5 24385-210 HUMAN OTC DRUG
Anti-Itch Diphenhydramine hydrochloride and Zinc acetate CREAM
en DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 20; 1 mg/g; mg/g
24385-213_f4841606-d060-43f6-9708-4dca09847024 24385-213 HUMAN OTC DRUG
GNP Idoinde Tincture 2% Mild Iodine and Sodium Iodide and Alcohol
LIQUID TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part333A
Amerisource Bergen ALCOHOL; IODINE; SODIUM IODIDE 470; 20; 20.4 mg/mL; m
g/mL; mg/mL
24385-255_5f550423-6d76-44c0-8531-657b5d7fe344 24385-255 HUMAN OTC DRUG
Good Neighbor Pharmacy Acid Reducer Famotidine "TABLET, COATED"
FAMOTIDINE 10 mg/1
24385-268_5075da08-56b5-400a-8219-31b8355652f6 24385-268 HUMAN OTC DRUG
Good Neighbor Pharmacy Acid Control 150 Maximum Strength Ranitidine
TABLET ORAL 20080219 ANDA ANDA078653 Amerisource Berg
en RANITIDINE HYDROCHLORIDE 150 mg/1
24385-278_a0828f44-e86a-4dc3-a7f4-e8d2e5a50d83 24385-278 HUMAN OTC DRUG
good neighbor pharmacy aspirin Aspirin "TABLET, CHEWABLE" ORAL
ASPIRIN 81 mg/1
24385-283_267b9c67-dec9-422c-a3e9-1d271fc0881b 24385-283 HUMAN OTC DRUG
good neighbor pharmacy anti itch HYDROCORTISONE LOTION TOPICAL
HYDROCORTISONE 1 g/mL
24385-289_1defa32d-33df-468e-b4a3-62050165a4f5 24385-289 HUMAN OTC DRUG
good neighbor pharmacy pain relief infants Acetaminophen SUSPENSION/ DROP
S ORAL 19931102 OTC MONOGRAPH NOT FINAL part343 Amerisou
rce Bergen ACETAMINOPHEN 80 mg/.8mL
24385-291_d6a19599-babf-4fe5-8857-157212949242 24385-291 HUMAN OTC DRUG
good neighbor pharmacy anti nausea "Dextrose (glucose), Levulose (f
ructose), Phosphoric Acid" LIQUID ORAL 19940401 UNAPPROV
ED DRUG OTHER Amerisource Bergen DEXTROSE; FRUCTOSE; PHOSPHORIC A
CID 1.87; 1.87; 21.5 g/5mL; g/5mL; mg/5mL
24385-296_71f078a3-fef8-40c2-b5c1-171f2729dec8 24385-296 HUMAN OTC DRUG
Good Neighbor Pharmacy Acid Control Ranitidine TABLET ORAL
20090516 ANDA ANDA076760 Amerisource Bergen RANITIDI
24385-305_c4517feb-1f6e-4b50-ae16-93bfd95ccec7 24385-305 HUMAN OTC DRUG
Good Neighbor Pharmacy Night Time D "Acetaminophen, Dextromethorphan
Hydrobromide, Doxylamine Succinate, Pseudoephedrine Hydrochloride" LIQUID
ORAL 19940828 OTC MONOGRAPH FINAL part341 Amerisource Berg
en ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PSEU
DOEPHEDRINE HYDROCHLORIDE 500; 15; 6.25; 30 mg/15mL; mg/15mL; mg/15m
L; mg/15mL
24385-310_01ae0d7d-c31d-4a47-b582-03b52a377cb7 24385-310 HUMAN OTC DRUG
good neighbor pharmacy tussin Guaifenesin SYRUP ORAL 19890815
OTC MONOGRAPH FINAL part341 Amerisource Bergen GUAIFENESIN 100
mg/5mL
24385-313_d35e9725-0348-4d7e-aa7f-0d172ea04526 24385-313 HUMAN OTC DRUG
good neighbor pharmacy pain relief infants Acetaminophen SUSPENSION/ DROP
24385-316_2f8b5a55-e5fc-47b4-8423-a9125558c0ed 24385-316 HUMAN OTC DRUG
Good Neighbor Pharmacy Night Time "acetaminophen,dextromethorphan
HBr, doxylamine succinate" LIQUID ORAL 20060523 OTC MONO
GRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; DEXTROMETHORPHAN
L
24385-322_8dbecba9-fa18-47a7-ad0e-afa2295e4072 24385-322 HUMAN OTC DRUG
Good Neighbor Pharmacy Night Time D "Acetaminophen, Dextromethorphan
HBr, Doxylamine Succinate, Pseudoephedrine HCl" LIQUID ORAL 19920929
HORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PSEUDOEPHEDRINE HYDROCHLORIDE
500; 15; 6.25; 30 mg/15mL; mg/15mL; mg/15mL; mg/15mL
24385-328_51bd7746-7d1c-407f-99c4-a4c9b4739e38 24385-328 HUMAN OTC DRUG
Good Neighbor Pharmacy Sore Throat Phenol SPRAY ORAL 19940103
OTC MONOGRAPH NOT FINAL part356 Amerisource Bergen PHENOL 1.4 mL/100mL
24385-332_b8e4953b-7002-44e4-9c80-bb5acc0a6344 24385-332 HUMAN OTC DRUG
good neighbor pharmacy milk of magnesia Magnesium hydroxide LIQUID
ORAL 19900415 OTC MONOGRAPH NOT FINAL part334 Amerisource Berg
en MAGNESIUM HYDROXIDE 1200 mg/15mL
24385-340_933dd446-73f6-47c6-be99-9130999393c2 24385-340 HUMAN OTC DRUG
Good Neighbor Pharmacy Antacid "aluminum hydroxide, magnesium hydroxide
, simethicone" LIQUID ORAL 19900915 OTC MONOGRAPH FINAL
part331 Amerisource Bergen ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDRO
24385-351_ab5a4d78-2aca-49e4-92e9-4efdcf6c8d93 24385-351 HUMAN OTC DRUG
allergy and congestion relief non drowsy "Pseudoephedrine sulfate, Lorata
dine" "TABLET, FILM COATED" ORAL 20101113 ANDA ANDA0759
89 Amerisource Bergen LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240
mg/1; mg/1
24385-352_ba4ae0d6-e8c1-48e3-8808-0c72cdf8e1f2 24385-352 HUMAN OTC DRUG
Good Neighbor Pharmacy Nasal Oxymetazoline HCl SPRAY NASAL
24385-356_1e9b7b3a-f41b-4223-83e9-88c0478aea67 24385-356 HUMAN OTC DRUG
Good Neighbor Pharmacy Antacid "Aluminum hydroxide, Magnesium hydroxide
24385-357_d37ef20d-96a4-4847-97c1-ed759740f3d9 24385-357 HUMAN OTC DRUG
Good Neighbor Pharmacy Antacid "Aluminum hydroxide, Magnesium hydroxide
24385-359_98f08e40-896b-4bdf-b21c-6080c574d8d1 24385-359 HUMAN OTC DRUG
Good Neighbor Pharmacy Tussin dm "Dextromethorphan Hydrobromide,
Guaifenesin" LIQUID ORAL 19910827 OTC MONOGRAPH FINAL
part341 Amerisource Bergen DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
20; 200 mg/10mL; mg/10mL
24385-361_b9124d04-b5d5-432b-b9d4-694ef43ecccc 24385-361 HUMAN OTC DRUG
Good Neighbor Pharmacy Childrens Ibuprofen Ibuprofen SUSPENSI
ON ORAL 20020513 ANDA ANDA074937 Amerisource Berg
en IBUPROFEN 100 mg/5mL
24385-362_3ae98cd1-9c85-4396-ae67-b6a45a6924ea 24385-362 HUMAN OTC DRUG
Good Neighbor Pharmacy Antacid "Aluminum Hydroxide, Magnesium Hydroxide
24385-364_92594258-bf2a-4756-831e-7552104565a2 24385-364 HUMAN OTC DRUG
Good Neighbor Pharmacy aspirin orange flavor chewable Aspirin "TABLET, CHEWABL
E" ORAL 20020220 OTC MONOGRAPH NOT FINAL part343 Amerisou
rce Bergen ASPIRIN 81 mg/1
24385-365_8f1833a3-b63b-4e30-a159-29e36ad1233f 24385-365 HUMAN OTC DRUG
good neighbor pharmacy migraine relief "Acetaminophen, Aspirin, Caffein
e" "TABLET, FILM COATED" ORAL 20020513 ANDA ANDA0757
94 Amerisource Bergen ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250
; 65 mg/1; mg/1; mg/1
24385-368_2ed306ab-522a-450f-99e8-0e78c3199875 24385-368 HUMAN OTC DRUG
good neighbor pharmacy pain relief all day Naproxen Sodium "TABLET, FILM CO
en NAPROXEN SODIUM 220 mg/1
24385-372_8164c048-4839-44c9-b12e-91933729c00d 24385-372 HUMAN OTC DRUG
Good Neighbor Pharmacy Childrens Ibuprofen Ibuprofen SUSPENSI
24385-374_66ff4738-f36c-4b19-ac1f-a152a42990d7 24385-374 HUMAN OTC DRUG
Good Neighbor Pharmacy Tioconazole 1 Tioconazole OINTMENT
VAGINAL 20080220 ANDA ANDA075915 Amerisource Bergen
TIOCONAZOLE 6.5 g/100g
24385-377_e6f5d456-c674-4b93-80b4-2a57e23bf8ed 24385-377 HUMAN OTC DRUG
Good Neighbor Pharmacy Anti Diarrheal Loperamide HCl SOLUTION
LOPERAMIDE HYDROCHLORIDE 1 mg/5mL
24385-379_55368104-06cb-4e80-b432-2e48bd23070b 24385-379 HUMAN OTC DRUG
Good Neighbor Pharmacy Childrens Allergy Liquid Diphenhydramine Hydrochl
oride LIQUID ORAL 19890815 OTC MONOGRAPH FINAL part341
Amerisource Bergen DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL
24385-385_0b0113b5-0dff-4ebf-9433-2ba762a7087b 24385-385 HUMAN OTC DRUG
Good Neighbor Pharmacy Acid Reducer Maximum Strength Famotidine
en FAMOTIDINE 20 mg/1
24385-386_8753a5ef-f87b-438a-a3a4-53827e946476 24385-386 HUMAN OTC DRUG
good neighbor pharmacy anti diarrheal Loperamide HCl "TABLET, FILM CO
en LOPERAMIDE HYDROCHLORIDE 2 mg/1
24385-390_32d3e008-c276-4076-840e-26db908e6384 24385-390 HUMAN OTC DRUG
good neighbor pharmacy nose Phenylephrine hydrochloride LIQUID
NASAL 19940401 OTC MONOGRAPH FINAL part341 Amerisource Berg
en PHENYLEPHRINE HYDROCHLORIDE 1 mL/100mL
24385-396_daf89e64-1d7d-46ae-8335-5edc234b71f0 24385-396 HUMAN OTC DRUG
Good Neighbor Pharmacy milk of magnesia Magnesium hydroxide LIQUID
24385-403_210b656e-88e7-4944-8fe8-0a67c5293553 24385-403 HUMAN OTC DRUG
good neighbor pharmacy pain relief regular strength Acetaminophen
TABLET ORAL 19900215 OTC MONOGRAPH NOT FINAL part343 Amerisou
rce Bergen ACETAMINOPHEN 325 mg/1
24385-405_0584d195-ae50-479d-9440-9fd6a07151e6 24385-405 HUMAN OTC DRUG
Good Neighbor Pharmacy Pain Relief Acetaminophen TABLET ORAL
24385-407_cb7abed3-d364-42c8-a69c-000cdf62d35a 24385-407 HUMAN OTC DRUG
Calamine Phenolated Topical Suspension Calamine and Zinc Oxide and Phen
ol LOTION TOPICAL 20080101 OTC MONOGRAPH FINAL part347
Amerisource Bergen PHENOL; ZINC OXIDE 10; 160 mg/mL; mg/mL
24385-413_ad05547f-dd58-4d38-b6db-cf26dd96de6c 24385-413 HUMAN OTC DRUG
GNP Calamine Topical Suspension Calamine 8% and Zinc Oxide 8% LOTION
en ZINC OXIDE 160 mg/mL
24385-416_91412263-9c8f-4705-9398-fd503026df21 24385-416 HUMAN OTC DRUG
Good Neighbor Pharmacy Aspirin Aspirin TABLET ORAL 19890915
OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ASPIRIN 325 mg/1
24385-421_ba83b1fe-23a3-4673-8b31-e47d02cf1cd7 24385-421 HUMAN OTC DRUG
Hemorrhoidal Cooling Gel phenylephrine and witch hazel GEL
en PHENYLEPHRINE HYDROCHLORIDE; WITCH HAZEL .25; 50 g/g; g/g
24385-428_4183595f-bbb8-41e9-ba75-807055c47848 24385-428 HUMAN OTC DRUG
Good Neighbor Pharmacy Gas Relief Simethicone "CAPSULE, LIQUID
FILLED" ORAL 19990812 OTC MONOGRAPH FINAL part332
Amerisource Bergen DIMETHICONE 125 mg/1
24385-430_a56ea03d-21f7-481c-87e3-a21f023f0d2b 24385-430 HUMAN OTC DRUG
good neighbor pharmacy headache relief "Acetaminophen, Aspirin, Caffein
T FINAL part343 Amerisource Bergen ACETAMINOPHEN; ASPIRIN; CAFFEINE
250; 250; 65 mg/1; mg/1; mg/1
24385-431_5b806dae-64f9-4f3a-b4cf-ac89f0d16a72 24385-431 HUMAN OTC DRUG
Good Neighbor Pharmacy Sleep Aid Diphenhydramine Hydrochloride
TABLET ORAL 20010414 OTC MONOGRAPH FINAL part338 Amerisou
rce Bergen DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1
24385-432_3f78baf7-3582-48c7-9ecc-86115ac32e84 24385-432 HUMAN OTC DRUG
Good Neighbor Pharmacy Nasal Decongestant Pseudoephedrine HCl
part341 Amerisource Bergen PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1
24385-437_f2ffeead-9b8c-4230-b7df-bc94f0ea8ca6 24385-437 HUMAN OTC DRUG
Good Neighbor Pharmacy Pain Relief PM "Acetaminophen, Diphenhydramine
NAL part338 Amerisource Bergen ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLO
RIDE 500; 25 mg/1; mg/1
24385-439_2fbbb4fa-1f07-4adb-b2ba-50a15dd2dec9 24385-439 HUMAN OTC DRUG
Caldyphen Clear Pramoxine Hydrochloride and Zinc acetate LOTION
en PRAMOXINE HYDROCHLORIDE; ZINC ACETATE 10; 1 mg/mL; mg/mL
24385-441_0c4f7232-4889-4cca-a807-c6d6aaa183e6 24385-441 HUMAN OTC DRUG
Good Neighbor Pharmacy Sleep Aid Doxylamine succinate TABLET
DOXYLAMINE SUCCINATE 25 mg/1
24385-461_3cfaee9f-cbb6-45c3-8674-121622195cdd 24385-461 HUMAN OTC DRUG
Good Neighbor Pharmacy night time cough "Dextromethorphan Hydrobromide,
Doxylamine Succinate" LIQUID ORAL 20030630 OTC MONOGRAPH FI
NAL part341 Amerisource Bergen DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMIN
E SUCCINATE 15; 6.25 mg/15mL; mg/15mL
24385-462_222c5ddd-cc5a-48e1-854f-d8129aa24ad1 24385-462 HUMAN OTC DRUG
good neighbor pharmacy allergy diphenhydramine hydrochloride CAPSULE
en DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1
24385-463_01a87ff3-154b-4116-af37-1e48251cba9f 24385-463 HUMAN OTC DRUG
Good Neighbor Pharmacy Allergy Chlorpheniramine Maleate TABLET
en CHLORPHENIRAMINE MALEATE 4 mg/1
24385-465_319c72cd-dd49-4193-9118-b9c164cd0a9a 24385-465 HUMAN OTC DRUG
Good Neighbor Pharmacy Ibuprofen Cold and Sinus "Ibuprofen, Pseudoephedr
ine Hydrochloride" TABLET ORAL 20011015 ANDA ANDA0745
67 Amerisource Bergen IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
200; 30 mg/1; mg/1
24385-471_cd474233-faa0-460a-bdbb-f506e0998cc7 24385-471 HUMAN OTC DRUG
good neighbor pharmacy loratadine Loratadine TABLET ORAL
20081110 ANDA ANDA076301 Amerisource Bergen LORATADI
NE 10 mg/1
24385-479_9f268bff-e591-42f6-bdda-2309b42ab1b7 24385-479 HUMAN OTC DRUG
Good Neighbor Pharmacy allergy Diphenhydramine Hydrochloride TABLET
en DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1
24385-484_eca3875d-bae6-41dd-b520-a86fae96f062 24385-484 HUMAN OTC DRUG
Good Neighbor Pharmacy Pain Relief Acetaminophen TABLET ORAL
24385-490_61f06b0e-358c-409d-81cf-9cb65a8f579f 24385-490 HUMAN OTC DRUG
Good Neighbor Pharmacy naproxen sodium Naproxen Sodium TABLET ORAL
19980312 ANDA ANDA074661 Amerisource Bergen NAPROXEN
SODIUM 220 mg/1
24385-493_2f97b007-e5ff-479e-bb80-7b47b5aa52f9 24385-493 HUMAN OTC DRUG
Good Neighbor Pharmacy Tussin Dextromethorphan Hydrobromide LIQUID
en DEXTROMETHORPHAN HYDROBROMIDE 30 mg/10mL
24385-494_5544cd84-64f5-488d-acb5-c6f3666051db 24385-494 HUMAN OTC DRUG
good neighbor pharmacy eye itch relief Ketotifen Fumarate SOLUTION
OPHTHALMIC 20101113 ANDA ANDA077958 Amerisource Berg
en KETOTIFEN FUMARATE 0.25 mg/mL
24385-498_f5107d5a-bd5c-4ae5-b374-5babd769eb1c 24385-498 HUMAN OTC DRUG
Good Neighbor Pharmacy Nasal Oxymetazoline HCl SPRAY NASAL
24385-517_730cbc91-f2d9-41b6-8e56-d7e1e931e17d 24385-517 HUMAN OTC DRUG
good neighbor pharmacy cold and allergy childrens "phenylephrine hcl, brom
pheniramine maleate" LIQUID ORAL 20060919 OTC MONOGRAPH FI
NAL part341 Amerisource Bergen BROMPHENIRAMINE MALEATE; PHENYLEPHRINE H
YDROCHLORIDE 1; 2.5 mg/5mL; mg/5mL
24385-518_2f0ef205-49bb-4a74-b000-2f9823ec6179 24385-518 HUMAN OTC DRUG
Good Neighbor Pharmacy Allergy Relief Loratadine "TABLET, ORALLY
DISINTEGRATING" ORAL 20040315 ANDA ANDA075990 Amerisou
rce Bergen LORATADINE 10 mg/1
24385-519_da91e6b6-32ff-44fd-afce-33ea9549554b 24385-519 HUMAN OTC DRUG
good neighbor pharmacy cold and cough "Brompheniramine maleate, Dextro
methorphan HBr, Phenylephrine HCl" LIQUID ORAL 20060911
OTC MONOGRAPH FINAL part341 Amerisource Bergen BROMPHENIRAMINE MALEATE;
24385-532_8c834486-0f6f-44f4-a15b-06d0e3d417cc 24385-532 HUMAN OTC DRUG
Good Neighbor Pharmacy Sore Throat Phenol SPRAY ORAL 19930409
OTC MONOGRAPH NOT FINAL part356 Amerisource Bergen PHENOL 1.4 mL/100mL
24385-535_e3f7bc4a-73df-4203-9099-c6805c57f7ea 24385-535 HUMAN OTC DRUG
Good Neighbor Pharmacy Aspirin Enteric Safety Coated Aspirin "TABLET, DELAYED
RELEASE" ORAL 19940329 OTC MONOGRAPH NOT FINAL part343
Amerisource Bergen ASPIRIN 81 mg/1
24385-541_c88c0cf5-71fb-45fd-adca-1f7746665e78 24385-541 HUMAN OTC DRUG
good neighbor pharmacy aspirin Aspirin "TABLET, FILM COATED" ORAL
ASPIRIN 81 mg/1
24385-542_f2163736-58e5-4556-857c-c037bd5f8267 24385-542 HUMAN OTC DRUG
good neighbor pharmacy cold severe "Acetaminophen, Dextromethorphan HBr, Gu
aifenesin, Phenylephrine HCl" "TABLET, COATED" ORAL 19910615
mg/1; mg/1; mg/1; mg/1
24385-544_fe36dc63-673d-4466-b2d6-bada809bdf1c 24385-544 HUMAN OTC DRUG
Good Neighbor Pharmacy headache relief "Acetaminophen, Caffeine"
part343 Amerisource Bergen ACETAMINOPHEN; CAFFEINE 500; 65 mg/1; mg/1
24385-546_c02a347d-df05-4191-b506-1b2ad754a014 24385-546 HUMAN OTC DRUG
good neighbor pharmacy ibuprofen Ibuprofen "TABLET, CHEWABL
E" ORAL 20041012 ANDA ANDA076359 Amerisource Berg
en IBUPROFEN 100 mg/1
24385-549_224ea181-4beb-4102-a263-31c9a4c84cdf 24385-549 HUMAN OTC DRUG
Good Neighbor Pharmacy Childrens Ibuprofen Cold "Ibuprofen, Pseudoephedr
ine HCl" SUSPENSION ORAL 19890415 ANDA ANDA0764
78 Amerisource Bergen IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
100; 15 mg/5mL; mg/5mL
24385-550_19d3af1c-9dd5-48d9-bd5c-05cc8745e836 24385-550 HUMAN OTC DRUG
good neighbor pharmacy ibuprofen Ibuprofen SUSPENSION/ DROP
S ORAL 20041012 ANDA ANDA075217 Amerisource Berg
en IBUPROFEN 50 mg/1.25mL
24385-554_48078785-0384-4ca5-bd95-a8b3602084ae 24385-554 HUMAN OTC DRUG
good neighbor pharmacy anti diarrheal Loperamide Hydrochloride
Amerisource Bergen LOPERAMIDE HYDROCHLORIDE 2 mg/1
24385-578_f019fe3b-3e5c-4bff-ae8d-d366b3ce0d90 24385-578 HUMAN OTC DRUG
good neighbor pharmacy tussin dm "Dextromethorphan HBr, Guaifenes
in" LIQUID ORAL 19940919 OTC MONOGRAPH FINAL part341
Amerisource Bergen DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100
mg/5mL; mg/5mL
24385-590_5a3441e8-f4fc-404f-8e9e-6d2aee2b8cec 24385-590 HUMAN OTC DRUG
Good Neighbor Pharmacy Miconazole 7 Miconazole nitrate CREAM
VAGINAL 19991011 ANDA ANDA074760 Amerisource Bergen
MICONAZOLE NITRATE 2 g/100g
24385-594_7e98cdd9-b17c-4d58-a3e5-189c2ed893d2 24385-594 HUMAN OTC DRUG
NICOTINE 2 mg/1
24385-597_d0dfa008-d983-4df6-b4a9-25cc48e0610f 24385-597 HUMAN OTC DRUG
NICOTINE 2 mg/1
24385-598_9c687395-71d6-452a-a4fa-2bb5cf61b7e1 24385-598 HUMAN OTC DRUG
NICOTINE 4 mg/1
24385-599_02afc81c-54fa-4595-822c-e180ac69fae8 24385-599 HUMAN OTC DRUG
NICOTINE 4 mg/1
24385-601_6dfa8621-2e13-4f4d-a0f7-6c7c8fbb2bf5 24385-601 HUMAN OTC DRUG
Good Neighbor Pharmacy Stay Awake Caffeine TABLET ORAL
CAFFEINE 200 mg/1
24385-603_4f9ec868-c0d8-4b1a-9760-81cf44317cfc 24385-603 HUMAN OTC DRUG
good neighbor pharmacy nasal decongestant pe non drowsy Phenylephrine Hy
drochloride TABLET ORAL 20050628 OTC MONOGRAPH FINAL
part341 Amerisource Bergen PHENYLEPHRINE HYDROCHLORIDE 10 mg/1
24385-604_36427096-37ca-4dee-a972-746e350ea13e 24385-604 HUMAN OTC DRUG
good neighbor pharmacy ibuprofen Ibuprofen TABLET ORAL
19900115 ANDA ANDA072096 Amerisource Bergen IBUPROFE
N 200 mg/1
24385-606_5b87b837-3f52-40ca-b2b6-9c1f1262d90d 24385-606 HUMAN OTC DRUG
Good Neighbor Pharmacy Miconazole Nitrate Miconazole nitrate
KIT 20000502 ANDA ANDA075329 Amerisource Berg
en
24385-608_a479d194-c11a-4cf5-a1bb-ca63304af93d 24385-608 HUMAN OTC DRUG
good neighbor pharmacy milk of magnesia Magnesium hydroxide LIQUID
24385-618_ebee4335-7cbb-45bd-828c-e19b12f7c272 24385-618 HUMAN OTC DRUG
Good Neighbor Pharmacy Pain Relief Acetaminophen "TABLET, COATED"
en ACETAMINOPHEN 500 mg/1
24385-619_701b11fe-be96-4ffd-94dc-f986f2404621 24385-619 HUMAN OTC DRUG
Daily Moisturizing Dimethicone LOTION TOPICAL 20100712
OTC MONOGRAPH FINAL part347 Amerisource Bergen DIMETHICONE 13.13
mg/mL
24385-623_90d6542f-ef5f-4d90-a6f1-26e371600bb7 24385-623 HUMAN OTC DRUG
good neighbor pharmacy Ibuprofen Ibuprofen SUSPENSION
24385-629_926ea85a-d601-40fc-9c04-ef65f741f082 24385-629 HUMAN OTC DRUG
good neighbor pharmacy pain relief Acetaminophen "TABLET, FILM CO
Amerisource Bergen ACETAMINOPHEN 650 mg/1
24385-634_8e1085cc-f9d9-4961-b2b1-ef9619ec227a 24385-634 HUMAN OTC DRUG
good neighbor pharmacy lice "piperonyl butoxide, pyrethrum extract"
KIT 19940401 OTC MONOGRAPH FINAL part358G
Amerisource Bergen
24385-647_d1942bb6-9102-4406-a349-953c44d72b27 24385-647 HUMAN OTC DRUG
good neighbor pharmacy ibuprofen Ibuprofen "TABLET, COATED"
IBUPROFEN 200 mg/1
24385-677_fc3314e9-515c-4c72-8781-ffa1c1246ace 24385-677 HUMAN OTC DRUG
Good Neighbor Pharmacy Arthritis Pain Relief Capsaicin CREAM
en CAPSAICIN 0.1 g/100g
24385-904_2aac4a65-7c19-4bea-b077-5d4d7a3c4bc4 24385-904 HUMAN OTC DRUG
Good Neighbor Pharmacy Tussin CF "Dextromethorphan Hydrobromide,
Guaifenesin, Phenylephrine Hydrochloride" LIQUID ORAL 20060327
OTC MONOGRAPH FINAL part341 Amerisource Bergen DEXTROMETHORPHAN HYDROBR
OMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL
; mg/10mL
24385-905_978661f1-6844-4b9c-ade5-edd685982a2c 24385-905 HUMAN OTC DRUG
good neighbor pharmacy ibuprofen Ibuprofen SUSPENSION
24385-924_2ae049d2-f7b1-494b-8b56-ea35f9c33a60 24385-924 HUMAN OTC DRUG
good neighbor pharmacy cold and allergy pe "Chlorpheniramine maleate, Pheny
lephrine HCl" "TABLET, FILM COATED" ORAL 20061121 OTC MONO
GRAPH FINAL part341 Amerisource Bergen CHLORPHENIRAMINE MALEATE; PHENYL
EPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1
24385-937_e6cd7017-34bb-47a1-b6d3-ccde3daaa4fb 24385-937 HUMAN OTC DRUG
Good Neighbor Pharmacy Ibuprofen PM "diphenhydramine citrate, ibupro
fen" "TABLET, COATED" ORAL 20090223 ANDA ANDA0791
13 Amerisource Bergen DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200
mg/1; mg/1
24385-958_5996132f-13c9-49a3-ab9e-751db97484ba 24385-958 HUMAN OTC DRUG
good neighbor pharmacy cold remedy "Zincum Aceticum, Zincum Gluconi
cum" "TABLET, ORALLY DISINTEGRATING" ORAL 20080805 UNAPPROV
ED HOMEOPATHIC Amerisource Bergen ZINC ACETATE; ZINC GLUCONATE
2; 1 [hp_X]/1; [hp_X]/1
24385-959_28298cb1-d443-4429-9237-8914bdb89748 24385-959 HUMAN OTC DRUG
good neighbor pharmacy sinus "Acetaminophen, Chlorpheniramine maleate
, Phenylephrine HCl" KIT 20080902 OTC MONOGRAPH FI
NAL part341 Amerisource Bergen
24385-961_1fa9b5cf-6534-460a-897e-1716a273e133 24385-961 HUMAN OTC DRUG
Good Neighbor Pharmacy Sinus and Allergy PE "Chlorpheniramine maleat
e, Phenylephrine HCl" "TABLET, FILM COATED" ORAL 20061120
OTC MONOGRAPH FINAL part341 Amerisource Bergen CHLORPHENIRAMINE MALEATE
; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1
24385-962_85651bca-ba47-45af-a6eb-94f6c64222b1 24385-962 HUMAN OTC DRUG
good neighbor pharmacy cold "Acetaminophen, Chlorpheniramine maleate
OTC MONOGRAPH FINAL part341 Amerisource Bergen
24385-963_6cc4f501-385c-4f3d-bf19-b8af854ca8e7 24385-963 HUMAN OTC DRUG
good neighbor pharmacy cold "Acetaminophen, Chlorpheniramine maleate
OTC MONOGRAPH FINAL part341 Amerisource Bergen
24385-975_cbac6443-b5f1-4ed1-8415-cdd8c785ddee 24385-975 HUMAN OTC DRUG
good neighbor pharmacy nicotine Nicotine Polacrilex LOZENGE ORAL
20071010 ANDA ANDA077007 Amerisource Bergen NICOTINE
2 mg/1
24385-976_44978961-0d6f-423b-8e21-1e79745ef299 24385-976 HUMAN OTC DRUG
good neighbor pharmacy nicotine Nicotine Polacrilex LOZENGE ORAL
4 mg/1
24385-980_1652f850-ffd6-46b9-8b37-4d5c0bbbfc81 24385-980 HUMAN OTC DRUG
Cold Sore Treatment Benzalkonium Chloride TINCTURE TOPICAL
20070601 OTC MONOGRAPH NOT FINAL part333A Amerisource Berg
en BENZALKONIUM CHLORIDE 0.13 mL/mL
24385-982_ae267fb9-5f23-4f9e-8138-b17d1e37d606 24385-982 HUMAN OTC DRUG
Pain Relief Alcohol Swabs benzocaine SWAB TOPICAL 20070501
OTC MONOGRAPH NOT FINAL part348 Amerisource Bergen BENZOCAINE; ISOPROPYL AL
COHOL .06; .7 mL/1; mL/1
24385-984_636ecb5b-0391-41cf-b314-0e4a9fd9458e 24385-984 HUMAN OTC DRUG
good neighbor pharmacy cold plus multi symptom "Acetaminophen, Chlorphe
niramine Maleate, Dextromethorphan HBr, Phenylephrine HCl" SUSPENSION
en ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE;
PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL
24385-986_9a849064-dbd2-40dc-b2a9-e59c06187c0b 24385-986 HUMAN OTC DRUG
good neighbor pharmacy childrens pain relief plus cough and sore throat
"Acetaminophen, Dextromethorphan HBr" SUSPENSION ORAL 20080805
HORPHAN HYDROBROMIDE 160; 5 mg/5mL; mg/5mL
24385-987_94404408-7e8d-4907-9310-07c7359d6cfb 24385-987 HUMAN OTC DRUG
Good Neighbor Pharmacy Pain Relief and Pain Relief PM "Acetaminophen,
Diphenhydramine HCl" KIT 20070905 OTC MONOGRAPH FI
NAL part338 Amerisource Bergen
24385-988_7310f8f2-aaba-45c0-8add-d59b8fb7edda 24385-988 HUMAN OTC DRUG
good neighbor pharmacy flu and severe cold daytime "Acetaminophen, Phenylep
hrine hydrochloride" "POWDER, FOR SUSPENSION" ORAL 20070821
OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; PHENYLEPH
RINE HYDROCHLORIDE 650; 10 mg/16000mg; mg/16000mg
24385-998_f58ead80-748d-4ad8-8a4a-6fccd47f39bf 24385-998 HUMAN OTC DRUG
good neighbor pharmacy all day allergy Cetirizine Hydrochloride
en CETIRIZINE HYDROCHLORIDE 10 mg/1
46122-003_37732ff9-693e-44ec-a4c0-bc920d700389 46122-003 HUMAN OTC DRUG
Good Neighbor Pharmacy Pain Relief Rapid Release Extra Strength Acetamin
ophen "TABLET, COATED" ORAL 20090810 OTC MONOGRAPH NO
T FINAL part343 Amerisource Bergen ACETAMINOPHEN 500 mg/1
46122-004_72e52711-20e3-40d2-8e1e-f59cd8641c39 46122-004 HUMAN OTC DRUG
Good Neighbor Pharmacy Day Time "Acetaminophen, Phenylephrine HCl"
"CAPSULE, LIQUID FILLED" ORAL 20091224 OTC MONOGRAPH FI
NAL part341 Amerisource Bergen ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORI
DE 325; 5 mg/1; mg/1
46122-006_aabf1e1a-1c8c-42e8-9dad-cf9b3addf93e 46122-006 HUMAN OTC DRUG
Good Neighbor Pharmacy Night Time "Acetaminophen, Doxylamine Succi
nate, Phenylephrine HCl" "CAPSULE, LIQUID FILLED" ORAL 20091207
OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; DOXYLAMIN
E SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 6.25; 5 mg/1; mg/1; mg/1
46122-008_4471cf9d-2b3f-492b-b2a9-7121b2750aa6 46122-008 HUMAN OTC DRUG
Good Neighbor Pharmacy Night Time "acetaminophen, dextromethorphan
hydrobromide and doxylamine succinate" LIQUID ORAL 20090622
; mg/15mL
46122-010_46bb0d99-489d-49bb-bdc6-4cf668e8ac61 46122-010 HUMAN OTC DRUG
Good Neighbor Pharmacy Ibuprofen Ibuprofen TABLET ORAL
20091019 ANDA ANDA076359 Amerisource Bergen IBUPROFE
N 100 mg/1
46122-013_95e3b870-6f78-4ace-83de-da19b6d7c087 46122-013 HUMAN OTC DRUG
GOOD NEIGHBOR PHARMACY DIAPER RASH CREAMY ZINC OXIDE OINTMENT
TOPICAL 20120501 OTC MONOGRAPH FINAL part347 AMERISOURCE BERG
EN ZINC OXIDE 0.1 g/g
46122-014_4a0a5783-6eb2-41f4-b9e7-1f71489011dd 46122-014 HUMAN OTC DRUG
Good Neighbor Pharmacy ClearLax Polyethylene Glycol 3350 "POWDER,
FOR SOLUTION" ORAL 20091019 ANDA ANDA090685 Amerisou
rce Bergen POLYETHYLENE GLYCOL 3350 17 g/17g
46122-017_5930ec18-554d-4bb0-9387-ce4010aa71f4 46122-017 HUMAN OTC DRUG
Good Neighbor Pharmacy tussin dm max adult "Dextromethorphan HBr, Guaifenes
in" LIQUID ORAL 20100907 OTC MONOGRAPH FINAL part341
Amerisource Bergen DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400
mg/10mL; mg/10mL
46122-018_e0aee839-06bb-4398-aa39-eb623dbfca37 46122-018 HUMAN OTC DRUG
GNP Lubricant Eye Polyethylene Glycol 400 SOLUTION/ DROPS OPHTHALM
IC 20130630 OTC MONOGRAPH FINAL part349 Amerisource Berg
en POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL .4; .3 mg/mg; mg/mg
46122-019_f520f6c7-cc07-482d-8047-ded05dc7db2d 46122-019 HUMAN OTC DRUG
good neighbor pharmacy pain relief Acetaminophen SUSPENSION
en ACETAMINOPHEN 160 mg/5mL
46122-020_37155b8d-d193-4f3e-8cd6-a904d11854f8 46122-020 HUMAN OTC DRUG
Good Neighbor Pharmacy Allergy childrens all day cetirizine Hydrochloride
LIQUID ORAL 20101029 ANDA ANDA090254 Amerisource Berg
en CETIRIZINE HYDROCHLORIDE 5 mg/5mL
46122-021_377332f1-5a4d-469b-8f38-00ca81a53c37 46122-021 HUMAN OTC DRUG
Pre Menstrual relief maximum strength "ACETAMINOPHEN, PAMABROM, PYRILA
MINE MALEATE" TABLET ORAL 20110107 OTC MONOGRAPH NOT FINAL
part343 Amerisource Bergen ACETAMINOPHEN; PAMABROM; PYRILAMINE MALEATE
500; 25; 15 mg/1; mg/1; mg/1
46122-022_c49f1d75-1d2e-4bb5-96f1-a45c7cf51a75 46122-022 HUMAN OTC DRUG
good neighbor pharmacy flu and severe cold and cough "Acetaminophen,
Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride" "POWDER, FOR SOL
UTION" ORAL 20110204 OTC MONOGRAPH FINAL part341 Amerisou
rce Bergen ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDR
OCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1
46122-023_450a3afd-fcab-4770-b7f1-fad207eba67b 46122-023 HUMAN OTC DRUG
good neighbor pharmacy itchy eye Ketotifen SOLUTION
OPHTHALMIC 20101007 ANDA ANDA077958 Amerisource Berg
en KETOTIFEN FUMARATE 0.25 mg/mL
46122-026_f44ad51b-82e8-4f53-9a98-ad156b1ce2bb 46122-026 HUMAN OTC DRUG
good neighbor pharmacy pain relief pm "Acetaminophen, Diphenhydramine
HCl" "TABLET, COATED" ORAL 19950908 OTC MONOGRAPH FI
NAL part338 Amerisource Bergen ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLO
RIDE 500; 25 mg/1; mg/1
46122-027_c0faf439-1431-4300-9fcb-3a8128e613bc 46122-027 HUMAN OTC DRUG
good neighbor pharmacy miconazole 1 Miconazole nitrate KIT
20100611 ANDA ANDA079114 Amerisource Bergen
46122-028_4f6d1955-1962-47ce-b88c-3bb39c5347e8 46122-028 HUMAN OTC DRUG
Good Neighbor Pharmacy mucus er Guaifenesin "TABLET, EXTENDED RELEAS
E" ORAL 20130319 ANDA ANDA078912 Amerisource Berg
en GUAIFENESIN 600 mg/1
46122-029_2a30e8e8-f116-4c11-9085-2f1c2ff16e20 46122-029 HUMAN OTC DRUG
good neighbor pharmacy omeprazole Omeprazole "TABLET, DELAYED
RELEASE" ORAL 20080227 NDA NDA022032 Amerisou
rce Bergen OMEPRAZOLE 20 mg/1
46122-031_63b26d3e-760e-4177-8efc-8ae4750412bb 46122-031 HUMAN OTC DRUG
Good Neighbor Pharmacy Pain Relief Infants Acetaminophen SUSPENSION/ DROP
46122-032_12b4e960-0d33-478f-aaa2-208a3e80beaf 46122-032 HUMAN OTC DRUG
good neighbor pharmacy day time "Dextromethorphan HBr, Guaifenesin"
LIQUID ORAL 20101209 OTC MONOGRAPH FINAL part341 Amerisou
rce Bergen DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 200 mg/15mL;
mg/15mL
46122-037_5d0a9198-0226-4b02-97b4-af1dd5233d6b 46122-037 HUMAN OTC DRUG
good neighbor pharmacy flu and severe cold and cough nighttime "Acetami
nophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride" "POWDER,
FOR SOLUTION" ORAL 20110210 OTC MONOGRAPH FINAL part341
Amerisource Bergen ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHR
INE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1
46122-038_ca3fe06c-a37e-4f7d-99a3-031f36d88f6f 46122-038 HUMAN OTC DRUG
Good Neighbor Pharmacy Naproxen Sodium Naproxen sodium "CAPSULE, LIQUID
FILLED" ORAL 20110106 NDA NDA021920 Amerisou
rce Bergen NAPROXEN SODIUM 220 mg/1
46122-040_b65da823-00a0-43f7-8b2c-13971814959b 46122-040 HUMAN OTC DRUG
good neighbor pharmacy allergy relief fexofenadine hydrochloride
Amerisource Bergen FEXOFENADINE HYDROCHLORIDE 180 mg/1
46122-041_0750ee3a-5a4f-4b7f-83a5-256f5b7e6eaf 46122-041 HUMAN OTC DRUG
good neighbor pharmacy acid control 150 Ranitidine "TABLET, FILM CO
46122-042_e9818828-56f7-4b74-a7f4-55dbaf6ba61e 46122-042 HUMAN OTC DRUG
good neighbor pharmacy pain and fever Acetaminophen SUSPENSION
46122-044_f0abc596-7093-4a63-b3e5-d507c7085ba1 46122-044 HUMAN OTC DRUG
GNP Acne Treatment Benzoyl Peroxide CREAM TOPICAL 20130630
OTC MONOGRAPH FINAL part333D Amerisource Bergen BENZOYL PEROXIDE
10 g/100g
46122-054_6a40bc88-e271-484b-a860-3b52471da070 46122-054 HUMAN OTC DRUG
GNP Hygienic Cleansing Pads Witch Hazel SOLUTION RECTAL;
en WITCH HAZEL 0.5 mg/mg
46122-055_1b91f562-e8d2-42e9-9bea-ea24ec7234bf 46122-055 HUMAN OTC DRUG
GNP Medicated Wipes Witch Hazel SOLUTION RECTAL; TOPICAL
WITCH HAZEL 0.5 mg/mg
46122-056_7601d3c9-0fdb-422a-9d3b-603bb26c4866 46122-056 HUMAN OTC DRUG
good neighbor pharmacy Pain and Fever Acetaminophen LIQUID ORAL
46122-062_4fef2c61-8322-49ae-8bec-521fe9eb696b 46122-062 HUMAN OTC DRUG
46122-101_b1ebbc59-6846-4cf1-b4a7-3429ee26652c 46122-101 HUMAN OTC DRUG
All Day Allergy Cetirizine Hydrochloride SOLUTION ORAL 20110520
ANDA ANDA201546 Amerisource Bergen CETIRIZINE HYDROCHLORIDE
5 mg/5mL
46122-103_123321d5-bbda-4923-b9a4-7578521ec8f0 46122-103 HUMAN OTC DRUG
Good Neighbor Pharmacy Hemorrhoidal Mineral Oil OINTMENT
en MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 140; 74.9; 2.5
mg/100g; mg/100g; mg/100g
46122-104_e1f67e3f-d08e-4ec8-8b73-fb659154571d 46122-104 HUMAN OTC DRUG
Headache relief Extra Strength "Acetaminophen, Aspirin and Caffeine" TABLET
en ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1
46122-105_43b1148c-4f10-4b83-9f76-99a21c6a2e21 46122-105 HUMAN OTC DRUG
good neighbor pharmacy childrens pain relief Acetaminophen LIQUID
46122-106_329b4089-f9b9-4419-b8e0-f3ef00ba301b 46122-106 HUMAN OTC DRUG
good neighbor pharmacy pain relief acetaminophen LIQUID ORAL
46122-107_ebb45488-84f7-4d53-b8f1-0c5e06b2a951 46122-107 HUMAN OTC DRUG
Good Neighbor Pharmacy Lansoprazole Lansoprazole "CAPSULE, DELAYE
D RELEASE" ORAL 20120531 ANDA ANDA202319 Amerisou
rce Bergen LANSOPRAZOLE 15 mg/1
46122-108_cce3b28b-7761-4045-a631-380ed8e529c2 46122-108 HUMAN OTC DRUG
good neighbor pharmacy lice treatment Permethrin LOTION TOPICAL
20120307 ANDA ANDA076090 Amerisource Bergen PERMETHR
IN 1 mg/100mL
46122-109_ab2d358a-809c-435d-93ce-f36b55aa7880 46122-109 HUMAN OTC DRUG
good neighbor pharmacy loratadine d "Loratadine, Pseudoephedrine"
50 Amerisource Bergen LORATADINE; PSEUDOEPHEDRINE SULFATE 5; 120
mg/1; mg/1
46122-110_7189a96a-2384-40c5-aae5-6b5205ac2f3b 46122-110 HUMAN OTC DRUG
good neighbor pharmacy childrens ibuprofen Ibuprofen SUSPENSI
46122-111_541d7244-43ad-4624-b468-a7fb53604c38 46122-111 HUMAN OTC DRUG
good neighbor pharmacy Loperamide hydrochloride loperamide HCl LIQUID
LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL
46122-116_4d92cdaa-838a-4032-a837-0843bf035481 46122-116 HUMAN OTC DRUG
GOOD NEIGHBOR PHARMACY CAPSAICIN CAPSAICIN CREAM TOPICAL
20120401 OTC MONOGRAPH NOT FINAL part348 AMERISOURCE BERGEN
CAPSAICIN 0.1 g/100g
46122-118_08245596-67a0-44d0-8fc1-6cee506bdef2 46122-118 HUMAN OTC DRUG
GOOD NEIGHBOR PHARMACY ZINC OXIDE ZINC OXIDE OINTMENT
TOPICAL 20120401 OTC MONOGRAPH FINAL part347 AMERISOURCE BERG
EN ZINC OXIDE 20 g/100g
46122-125_a50e73ca-ef48-41d2-ae52-54ebf6ae50c9 46122-125 HUMAN OTC DRUG
good neighbor pharmacy hair regrowth treatment for men Minoxidil
"AEROSOL, FOAM" TOPICAL 20120302 ANDA ANDA091344 Amerisou
rce Bergen MINOXIDIL 5 g/100g
46122-134_5d5336ca-aa9e-49ed-9bb4-66ee75a4907c 46122-134 HUMAN OTC DRUG
good neighbor pharmacy headache pm "Acetaminophen, Diphenhydramine
HCl" "TABLET, FILM COATED" ORAL 20000201 OTC MONOGRAPH NO
T FINAL part343 Amerisource Bergen ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLO
RIDE 500; 25 mg/1; mg/1
46122-135_1e906c73-c8a5-426f-b4b3-567bfd724abc 46122-135 HUMAN OTC DRUG
Good Neighbor Pharmacy Flu and Sore throat "acetaminophen,phenirami
ne maleate, phenylephrine hydrochloride" "POWDER, FOR SUSPENSION"
en ACETAMINOPHEN; PHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20;
10 mg/15000mg; mg/15000mg; mg/15000mg
46122-136_480d97c0-7d5e-448b-8085-0904aa42e403 46122-136 HUMAN OTC DRUG
good neighbor pharmacy night time "Acetaminophen, Dextromethorphan
L
46122-138_bbc25148-faa2-4279-b1fe-469eb7b96fc0 46122-138 HUMAN OTC DRUG
good neighbor pharmacy tussin cf max "dextromethorphan hbr, guaifenes
in, phenylephrine hcl" LIQUID ORAL 20120802 OTC MONOGRAPH FI
NAL part341 Amerisource Bergen DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENES
46122-139_b92e5f7b-1096-496e-a03e-d7cd4e40e394 46122-139 HUMAN OTC DRUG
good neighbor pharmacy tussin dm max "dextromethorphan hbr, guaifenes
in" SUSPENSION ORAL 20120802 OTC MONOGRAPH FINAL
part341 Amerisource Bergen DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
20; 400 mg/10mL; mg/10mL
46122-141_290def93-d97a-4e52-a823-c8010cab3e2a 46122-141 HUMAN OTC DRUG
Good Neighbor Pharmacy Cough DM ER dextromethorphan polistirex
SUSPENSION ORAL 20120830 ANDA ANDA091135 Amerisou
rce Bergen DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL
46122-142_9b6558b9-557e-47c8-a6e7-58b84dd1eff5 46122-142 HUMAN OTC DRUG
Good Neighbor Pharmacy Cough DM ER dextromethorphan polistirex
rce Bergen DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL
46122-144_a19e42b2-6663-47c9-bb23-bcdeccf8eb0e 46122-144 HUMAN OTC DRUG
good neighbor pharmacy miconazole 3 Miconazole nitrate KIT
20120904 ANDA ANDA076357 Amerisource Bergen
46122-145_3907bb55-3c39-48b7-b905-ab2e8da34b5e 46122-145 HUMAN OTC DRUG
good neighbor pharmacy ibuprofen pm "Diphenhydramine citrate, Ibupro
fen" "TABLET, COATED" ORAL 20120802 ANDA ANDA0791
13 Amerisource Bergen DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200
mg/1; mg/1
46122-146_cd202a72-4588-4a96-a02d-9daedcbd3a24 46122-146 HUMAN OTC DRUG
Itchy Eye Drops ketotifen fumarate SOLUTION/ DROPS OPHTHALMIC
20131206 ANDA ANDA077958 Amerisource Bergen KETOTIFE
46122-158_edba298d-ed0a-4f7e-a1b0-0afff57a1edd 46122-158 HUMAN OTC DRUG
ANDA ANDA076134 Amerisource Bergen LORATADINE 10 mg/1
46122-163_e735287e-92a2-4037-8650-e763c6895af9 46122-163 HUMAN OTC DRUG
Eye Itch Relief ketotifen fumarate SOLUTION/ DROPS OPHTHALMIC
20131206 ANDA ANDA077958 Amerisource Bergen KETOTIFE
46122-165_19bd4732-786f-45b5-89e5-085c927883f6 46122-165 HUMAN OTC DRUG
good neighbor pharmacy nasal oxymetazoline hydrochloride SPRAY
NASAL 19900115 OTC MONOGRAPH FINAL part341 Amerisource Berg
en OXYMETAZOLINE HYDROCHLORIDE 0.05 g/100mL
46122-166_a8c0d9b9-de99-4e30-bd0f-18488585dc60 46122-166 HUMAN OTC DRUG
Pseudoephedrine Hydrochloride Pseudoephedrine Hydrochloride "TABLET,
42 Amerisource Bergen PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1
46122-167_75855860-b79d-41e4-80df-be40864823b5 46122-167 HUMAN OTC DRUG
Loratadine and Pseudoephedrine Sulfate Loratadine and Pseudoephedrine S
ulfate "TABLET, FILM COATED, EXTENDED RELEASE" ORAL 20041117
ANDA ANDA076557 Amerisource Bergen LORATADINE; PSEUDOEPHEDRINE SULF
ATE 10; 240 mg/1; mg/1
46122-168_5e636ca3-5c52-4c0e-8597-831268ad77f3 46122-168 HUMAN OTC DRUG
Famotidine Famotidine "TABLET, FILM COATED" ORAL 20100723
ANDA ANDA090283 Amerisource Bergen FAMOTIDINE 20 mg/1
46122-169_80a4c80a-d34f-48d8-8484-f605ad892a25 46122-169 HUMAN OTC DRUG
Loperamide Hydrochloride Loperamide Hydrochloride TABLET
LOPERAMIDE HYDROCHLORIDE 2 mg/1
46122-170_880665b0-58d2-4d20-b3ad-d0bd2ceacf0f 46122-170 HUMAN OTC DRUG
46122-171_60b50508-e617-44c6-a253-1cf774f88a1d 46122-171 HUMAN OTC DRUG
NICOTINE 2 mg/1
46122-172_c6067ce8-dd2f-4f4e-90f0-b5355c639763 46122-172 HUMAN OTC DRUG
NICOTINE 4 mg/1
46122-173_5fe15468-9619-475c-aae4-52777a08133a 46122-173 HUMAN OTC DRUG
NICOTINE 2 mg/1
46122-174_3d9b611a-13b7-4965-b451-da8fb3519774 46122-174 HUMAN OTC DRUG
NICOTINE 4 mg/1
46122-176_e8b5337f-76d8-4470-b426-b45ddd2deaa1 46122-176 HUMAN OTC DRUG
Good Neighbor Pharmacy Nicotine Nicotine Polacrilex LOZENGE ORAL
2 mg/1
46122-177_acf3c585-f19a-48c3-9e53-41c8349d982b 46122-177 HUMAN OTC DRUG
Good Neighbor Pharmacy Nicotine Nicotine Polacrilex LOZENGE ORAL
4 mg/1
46122-178_725a7684-d0b3-467f-bcab-762f52f7d74d 46122-178 HUMAN OTC DRUG
pain reliever extra strength Acetaminophen TABLET ORAL 20111108
OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ACETAMINOPHEN 500
mg/1
46122-185_72fd3fd4-7cb2-4057-8ea3-e5dfb1b40bf5 46122-185 HUMAN OTC DRUG
GOOD NEIGHBOR PHARMACY Hydrogen Peroxide Wipes HYDROGEN PEROXIDE
Amerisource Bergen HYDROGEN PEROXIDE 3 g/100g
46122-188_4848f613-6985-40df-9674-13cd889424b7 46122-188 HUMAN OTC DRUG
GOOD NEIGHBOR PHARMACY Isopropyl Alcohol Wipes ISOPROPYL ALCOHOL
Amerisource Bergen ISOPROPYL ALCOHOL 70 g/100g
46122-192_0e3a4653-feb8-460b-abd8-c61ead131710 46122-192 HUMAN OTC DRUG
Good neighbor pharmacy mucus relief "Acetaminophen, Dextromethorphan
HBr, Guaifenesin, Phenylephrine HCl" "TABLET, FILM COATED" ORAL 20130624
mg/1; mg/1; mg/1; mg/1
46122-193_d58cbcab-a364-4a19-8a6d-a4fde9cf0838 46122-193 HUMAN OTC DRUG
Good Neighbor Pharmacy Mucus Relief Severe Congestion and Cold "Acetami
nophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl" "TABLET, FILM CO
rce Bergen ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENY
46122-194_ffe34340-f3a4-447e-a516-3206c24ebec4 46122-194 HUMAN OTC DRUG
Good Neighbor Pharmacy Mucus Relief cold and sinus "Acetaminophen, guaifene
sin, phenylephrine HCl" "TABLET, COATED" ORAL 20130802
OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; GUAIFENES
IN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1
46122-195_f9cdf3df-bcc6-4438-96b2-4e284d7b76b6 46122-195 HUMAN OTC DRUG
good neighbor pharmacy lubricating plus carboxymethylcellulose sodium
"SOLUTION, GEL FORMING / DROPS" OPHTHALMIC 20130517 OTC MONO
GRAPH FINAL part349 Amerisource Bergen CARBOXYMETHYLCELLULOSE SODIUM
0.5 g/100mL
46122-197_a622259a-7530-4ca8-9eb5-4e02857a28f3 46122-197 HUMAN OTC DRUG
Good Neighbor Pharmacy Sinus and Cold D "Naproxen sodium, Pseudoephedrin
e HCl" "TABLET, FILM COATED" ORAL 20130822 ANDA ANDA0765
18 Amerisource Bergen NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE
220; 120 mg/1; mg/1
46122-198_b5e51e1e-980a-4811-9c51-ab5b55b1e572 46122-198 HUMAN OTC DRUG
good neighbor pharmacy night time cold and flu "Acetaminophen, Dextrome
thorphan HBr, Doxylamine succinate" LIQUID ORAL 20111016
; mg/30mL
46122-199_dc31df89-f45d-411f-9740-c586e5fa6211 46122-199 HUMAN OTC DRUG
PEG-Phen Lubricant Eye Drops Polyethylene Glycol 400 and Propylene Gl
ycol SOLUTION/ DROPS OPHTHALMIC 20130322 OTC MONOGRAPH FI
NAL part349 Amerisource Bergen POLYETHYLENE GLYCOL 400; PROPYLENE GLYCO
L 4; 3 mg/mL; mg/mL
46122-200_393a4319-d7b8-4181-8ea9-5b8f2d4a6a43 46122-200 HUMAN OTC DRUG
CMC Lubricant Eye Drops Carboxymethylcellulose Sodium SOLUTION/ DROPS
OPHTHALMIC 20130322 OTC MONOGRAPH FINAL part349 Amerisou
rce Bergen CARBOXYMETHYLCELLULOSE SODIUM 5 mg/mL
46122-201_4a345b8d-7853-42d9-bbd4-42b6a9c6e54e 46122-201 HUMAN OTC DRUG
PEG-Phen Ultra Lubricant Eye Drops Polyethylene Glycol 400 and Prop
ylene Glycol SOLUTION/ DROPS OPHTHALMIC 20130322 OTC MONO
GRAPH FINAL part349 Amerisource Bergen POLYETHYLENE GLYCOL 400; PROPYLE
NE GLYCOL 4; 3 mg/mL; mg/mL
46122-202_f506194d-c79f-4001-a651-e21a3f51b9db 46122-202 HUMAN OTC DRUG
Lubricant PM "Mineral Oil, White Petrolatum" OINTMENT OPHTHALM
IC 20130501 OTC MONOGRAPH FINAL part349 Amerisource Berg
en MINERAL OIL; PETROLATUM 425; 573 mg/g; mg/g
46122-204_50fb6db6-671d-4a91-b1cf-f3bc6a7c2500 46122-204 HUMAN OTC DRUG
Good Neighbor Pharmacy Sleep Time Diphenhydramine HCl LIQUID
en DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL
46122-205_c70dca82-e80d-43a4-93fc-45fc65638c6b 46122-205 HUMAN OTC DRUG
Good Neighbor Pharmacy acid reducer Famotidine TABLET ORAL
20091007 ANDA ANDA075400 Amerisource Bergen FAMOTIDI
NE 10 mg/1
46122-206_a509ff87-18a7-4f16-ba98-f3b3b55579a1 46122-206 HUMAN OTC DRUG
Good Neighbor Pharmacy loratadine d 24 hour "Loratadine, Pseudoephedrine Sul
fate" "TABLET, EXTENDED RELEASE" ORAL 20030623 ANDA
ANDA075706 Amerisource Bergen LORATADINE; PSEUDOEPHEDRINE SULFATE
10; 240 mg/1; mg/1
46122-208_92149bc5-7f66-4222-a9bd-d0228db2c394 46122-208 HUMAN OTC DRUG
Good Neighbor Pharmacy Sleep Time Diphenhydramine HCl "CAPSULE
, LIQUID FILLED" ORAL 20140130 OTC MONOGRAPH FINAL
part338 Amerisource Bergen DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1
46122-209_074fdf65-f6ce-46d4-87cc-46911c01cca5 46122-209 HUMAN OTC DRUG
Good Neighbor Pharmacy Childrens Pain and Fever Acetaminophen SUSPENSI
46122-210_268a789b-8f31-4739-9777-523249cac326 46122-210 HUMAN OTC DRUG
good neighbor pharmacy childrens pain and fever Acetaminophen SUSPENSI
46122-211_6ba153b7-9dc9-4e42-9176-13b3922268bd 46122-211 HUMAN OTC DRUG
Good Neighbor Pharmacy childrens pain and fever Acetaminophen SUSPENSI
46122-212_4320895a-4f9e-4ebd-bffa-0bc9a923d22c 46122-212 HUMAN OTC DRUG
good neighbor pharmacy childrens pain and fever Acetaminophen SUSPENSI
46122-213_26b587cf-cbf8-46f9-a0da-6f56e0aa8e3e 46122-213 HUMAN OTC DRUG
Good Neighbor Pharmacy Childrens Pain and Fever Acetaminophen LIQUID
46122-214_45f64a75-6d7b-47f3-a9f2-d15afa967b5c 46122-214 HUMAN OTC DRUG
Good Neighbor Pharmacy Childrens Pain and Fever Acetaminophen SUSPENSI
46122-215_90bf54f0-8db2-4ed2-80ac-6ee69ad30994 46122-215 HUMAN OTC DRUG
Good Neighbor Pharmacy Night Time "Acetaminophen, Dextromethorphan
L
46122-223_ace6f559-73e4-4853-a71f-5d3b7cb96031 46122-223 HUMAN OTC DRUG
Ranitidine Ranitidine "TABLET, FILM COATED" ORAL 20130906
ANDA ANDA201745 Amerisource Bergen RANITIDINE HYDROCHLORIDE
75 mg/1
46122-224_0e3080d6-b5cf-47ad-85fa-07c078474097 46122-224 HUMAN OTC DRUG
Good Neighbor Pharmacy Acid Control 150 Ranitidine "TABLET, FILM CO
46122-232_db8acaff-2e0b-4b8a-86c2-a1882f0fbcbe 46122-232 HUMAN OTC DRUG
Good Neighbor Pharmacy Severe Day Time "acetaminophen, dextromethorphan
HBr, guaifenesin, phenylephrine HCl" "TABLET, FILM COATED" ORAL 20140123
mg/1; mg/1; mg/1; mg/1
46122-233_343b4e11-b073-4529-aee5-55cd9347f50d 46122-233 HUMAN OTC DRUG
Good Neighbor Pharmacy Night Time Severe "Acetaminophen, Dextrome
thorphan HBr, Doxylamine Succinate, Phenylephrine HCl" SUSPENSION ORAL
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRIN
E HYDROCHLORIDE 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL
46122-234_2177247a-ea3f-41b4-a27b-1557f7c7ea5e 46122-234 HUMAN OTC DRUG
Good Neighbor Pharmacy Day Time Severe "acetaminophen, dextromethorphan
hbr, guaifenesin, phenylephrine hcl" SUSPENSION ORAL 20140109
mg/15mL; mg/15mL; mg/15mL; mg/15mL
46122-235_d2f65adf-35d1-49c2-8b06-6b03a46a1f16 46122-235 HUMAN OTC DRUG
good neighbor pharmacy childrens mucus relief "dextromethorphan HBr, g
uaifenesin, phenylephrine HCl" LIQUID ORAL 20140218 OTC MONO
GRAPH FINAL part341 Amerisource Bergen DEXTROMETHORPHAN HYDROBROMIDE; G
UAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 100; 2.5 mg/5mL; mg/5mL; mg/5mL
46122-241_2e7a424d-6626-4772-bb47-bd5d3dd181b3 46122-241 HUMAN OTC DRUG
Good Neighbor Pharmacy Loperamide Hydrochloride Loperamide Hydrochloride
rce Bergen LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL
46122-243_5d45feb2-6f84-4ee3-a764-2563a340e2e4 46122-243 HUMAN OTC DRUG
Good Neighbor Pharmacy Triple Antibiotic "bacitracin, neomycin, p
NAL part333B Amerisource Bergen BACITRACIN; NEOMYCIN SULFATE; PO
LYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g
46122-244_3d1694ea-3f3e-45d5-8edf-8b31ac7d3a40 46122-244 HUMAN OTC DRUG
Good Neighbor Pharmacy Antibiotic and Pain Relief "Neomycin, Polym
yxin B, Pramoxine HCl" CREAM TOPICAL 20140211 OTC MONOGRAPH FI
NAL part333B Amerisource Bergen NEOMYCIN SULFATE; POLYMYXIN B SU
LFATE; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [USP'U]/g; mg/g
46122-245_5749ce9d-e182-478f-ab88-b520a35a99a7 46122-245 HUMAN OTC DRUG
Good Neighbor Pharmacy Night Time "Acetaminophen, Dextromethorphan
HBr, Doxylamine succinate" "CAPSULE, GELATIN COATED" ORAL 20140306
46122-259_d62b3451-5494-400e-8bbe-f29f15a99b64 46122-259 HUMAN OTC DRUG
good neighbor pharmacy flu and severe cold and cough "Acetaminophen,
diphenhydramine hydrochloride, phenylephrine hydrochloride" "POWDER, FOR SOL
UTION" ORAL 20140731 OTC MONOGRAPH FINAL part341 Amerisou
rce Bergen ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDR
OCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1
46122-266_324cc1d7-e222-4da7-b19d-b103109f0c48 46122-266 HUMAN OTC DRUG
Good Neighbor Pharmacy Allergy Relief Fexofenadine Hydrochloride
Amerisource Bergen FEXOFENADINE HYDROCHLORIDE 180 mg/1
46122-274_cd7fa5a8-2384-4c85-ba66-3421c2bc7ee1 46122-274 HUMAN OTC DRUG
good neighbor pharmacy first aid "bacitracin zinc, neomycin, poly
myxin B" OINTMENT TOPICAL 20140730 OTC MONOGRAPH FI
NAL part333B Amerisource Bergen BACITRACIN ZINC; NEOMYCIN SULFAT
E; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g
46122-408_86601f32-9597-4e8a-95a1-4e7d174cfd82 46122-408 HUMAN OTC DRUG
GOOD NEIGHBOR PHARMACY CLEANSING PADS WITCH HAZEL SOLUTION
RECTAL; TOPICAL 20110601 OTC MONOGRAPH FINAL part346 AMERISOU
RCE BERGEN WITCH HAZEL 0.5 mL/mL
46122-500_bec4d347-c500-421f-97d5-1d648125ec4f 46122-500 HUMAN OTC DRUG
Saline Laxative sodium phosphate ENEMA RECTAL 20120831
OTC MONOGRAPH NOT FINAL part334 Amerisource Bergen "SODIUM PHOSPHATE, DIBAS
46122-600_9788c057-665e-4352-b03a-022259e5ae76 46122-600 HUMAN OTC DRUG
Good Neighbor Mineral Oil Laxative mineral oil ENEMA RECTAL
MINERAL OIL 118 mL/118mL
24385-021_a4313d5d-e549-49bf-b4d5-34b2a7d62c8b 24385-021 HUMAN OTC DRUG
Good Neighbor Pharmacy Hydrocortisone Plus 12 Moisturizers Hydrocortisone
CREAM TOPICAL 19891003 OTC MONOGRAPH NOT FINAL part348 Amerisou
rceBergen HYDROCORTISONE 1 g/100g
24385-060_27da22e1-d204-4a26-b449-873693070dcf 24385-060 HUMAN OTC DRUG
Good Neighbor Pharmacy Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL
20060511 OTC MONOGRAPH FINAL part333B AmerisourceBerge
n BACITRACIN ZINC 500 [iU]/g
24385-110_ebdb3ced-a710-4cbf-9950-e4980d4acadc 24385-110 HUMAN OTC DRUG
Good Neighbor Pharmacy Clotrimazole 3 Clotrimazole CREAM VAGINAL 20000412
NDA NDA021143 AmerisourceBergen CLOTRIMAZOLE 2 g/100g
24385-190_1bcedd11-81cc-47ed-b23d-416c614b19be 24385-190 HUMAN OTC DRUG
Good Neighbor Pharmacy Hydrocortisone With Aloe for Sensitive Skin Hydrocor
tisone CREAM TOPICAL 20010913 OTC MONOGRAPH NOT FINAL part348
AmerisourceBergen HYDROCORTISONE 0.5 g/100g
24385-205_00b4c106-346c-48a1-a62e-19230c73d15e 24385-205 HUMAN OTC DRUG
Good Neighbor Pharmacy Clotrimazole Clotrimazole CREAM TOPICAL 19930831
OTC MONOGRAPH FINAL part333C AmerisourceBergen CLOTRIMAZOLE
10 mg/g
24385-274_0e83d65a-46b5-44ae-8558-3392fe97a2c5 24385-274 HUMAN OTC DRUG
Good Neighbor Pharmacy Hydrocortisone with Aloe Hydrocortisone CREAM
TOPICAL 19950823 OTC MONOGRAPH NOT FINAL part348 AmerisourceBerge
n HYDROCORTISONE 1 g/100g
24385-276_2e83c8a7-5e89-40d4-86d7-ca9ad23d7516 24385-276 HUMAN OTC DRUG
Good Neighbor Pharmacy Hydrocortisone Hydrocortisone OINTMENT TOPICAL
19891003 OTC MONOGRAPH NOT FINAL part348 AmerisourceBergen
24385-404_9089757d-2174-4deb-8d40-cd36418ac9b9 24385-404 HUMAN OTC DRUG
Good Neighbor Senna Sennosides TABLET ORAL 20121102
OTC MONOGRAPH FINAL part334 AmerisourceBergen SENNOSIDES A AND B
8.6 mg/1
24385-524_60c3c3ef-8f8c-4650-9c71-c4bb8e7d74be 24385-524 HUMAN OTC DRUG
Good Neighbor Pharmacy Terbinafine Hydrochloride CREAM TOPICAL
20070702 ANDA ANDA077511 AmerisourceBergen TERBINAF
INE HYDROCHLORIDE 1 g/100g
24385-531_c173efeb-b7ef-4846-b161-7aad21f3a984 24385-531 HUMAN OTC DRUG
Good Neighbor Pharmacy Childrens Loratadine Loratadine SOLUTION
ORAL 20040820 ANDA ANDA076805 AmerisourceBergen
LORATADINE 5 mg/5mL
24385-543_f87a080d-e3aa-4698-8c65-915d8ea77da2 24385-543 HUMAN OTC DRUG
LORATADINE 5 mg/5mL
24385-803_11d662f9-9fe2-4ddf-9387-81c180345ceb 24385-803 HUMAN OTC DRUG
GOOD NEIGHBOR PHARMACY FIRST AID Contains 202 PIECES "BENZALKONIUM CH
LORIDE, LIDOCAINE, WATER, ISOPROPYL ALCOHOL, ASPIRIN, BENZOCAINE, ALCOHOL"
KIT 20100502 OTC MONOGRAPH FINAL part333 Amerisou
rceBergen
24385-804_31fe4b5d-bdbe-4366-b4b6-85fb0b4dba30 24385-804 HUMAN OTC DRUG
Good Neighbor Pharmacy Emergency Preparedness and First Aid Contains 167 Pieces
"BENZALKONIUM CHLORIDE, LIDOCAINE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN
B SULFATE, WATER, ISOPROPYL ALCOHOL, BENZOCAINE, ASPIRIN, ETHYL ALCOHOL"
KIT 20100524 OTC MONOGRAPH FINAL part354 Amerisou
rceBergen
46122-164_8ff17952-4a96-4093-8cca-fee6f443904c 46122-164 HUMAN OTC DRUG
LORATADINE 5 mg/5mL
46122-179_86fa81c8-3fd5-4bd0-99b8-d6b2ec7dc88b 46122-179 HUMAN OTC DRUG
Pain Relief PM Extra strength "Acetaminophen, Diphenhydramine HCl" "TABLET,
COATED" ORAL 20130423 OTC MONOGRAPH NOT FINAL part343
AmerisourceBergen (Good Neighbor Pharmacy) ACETAMINOPHEN; DIPHENHYDRAMINE H
46122-180_db6a1892-99b9-47e7-8a8c-640fc5f62b66 46122-180 HUMAN OTC DRUG
Aspirin Low Dose Safety Coated Aspirin "TABLET, COATED" ORAL 20130315
OTC MONOGRAPH NOT FINAL part343 AmerisourceBergen (Good Neighbor Pharmacy)
ASPIRIN 81 mg/1
46122-181_3dfeca9b-6eab-432e-bee0-b7d78faad480 46122-181 HUMAN OTC DRUG
Cold and Allergy Maximum Strength "Chlorpheniramine maleate, Pheny
lephrine HCl" TABLET ORAL 20110402 OTC MONOGRAPH FINAL
part341 AmerisourceBergen (Good Neighbor Pharmacy) CHLORPHENIRAMINE MALEATE
; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1
46122-182_8f4f52e1-db4d-42ee-ab2e-a05c6d637677 46122-182 HUMAN OTC DRUG
Aspirin Adult Low Strength Aspirin Aspirin "TABLET, COATED" ORAL
20110317 OTC MONOGRAPH FINAL part343 AmerisourceBergen (Good
Neighbor Pharmacy) ASPIRIN 81 mg/1
46122-183_47eb60d9-7647-4cbe-bd5a-efc86474790e 46122-183 HUMAN OTC DRUG
Night time cold and flu "Acetaminophen, Dextromethorphan Hydrobromide, D
oxylamine Succinate" "CAPSULE, LIQUID FILLED" ORAL 20130225
OTC MONOGRAPH FINAL part341 AmerisourceBergen (Good Neighbor Pharmacy)
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15;
6.25 mg/1; mg/1; mg/1
46122-184_5818e817-f2a5-4acd-baa2-98efd15fb558 46122-184 HUMAN OTC DRUG
Day time cold and flu "Acetaminophen, Dextromethorphan Hydrobromide, P
henylephrine Hydrochloride" "CAPSULE, LIQUID FILLED" ORAL 20130210
OTC MONOGRAPH FINAL part341 AmerisourceBergen (Good Neighbor Pharmacy)
325; 10; 5 mg/1; mg/1; mg/1
46122-207_d7904841-2352-42f4-8bc1-9426140ff45c 46122-207 HUMAN OTC DRUG
Anti-Diarrheal Loperamide HCl "CAPSULE, LIQUID FILLED" ORAL
20130607 NDA NDA021855 AmerisourceBergen (Good Neighbor
Pharmacy) 46122 LOPERAMIDE HYDROCHLORIDE 2 mg/1
46122-231_c930f949-4836-4e19-9ea8-3f474b3810d7 46122-231 HUMAN OTC DRUG
Stool Softener DOCUSATE SODIUM "CAPSULE, LIQUID FILLED" ORAL
20130730 OTC MONOGRAPH NOT FINAL part334 AmerisourceBergen (Good
Neighbor Pharmacy) 46122 DOCUSATE SODIUM 100 mg/1
46122-248_a6bf5862-20d0-4cb1-b664-b50be553dd6c 46122-248 HUMAN OTC DRUG
Headache Relief Extra Strength "Acetaminophen, Aspirin, Caffeine" TABLET
ORAL 20140131 OTC MONOGRAPH NOT FINAL part343 AmerisourceBerge
n (Good Neighbor Pharmacy) 46122 ACETAMINOPHEN; ASPIRIN; CAFFEINE
250; 250; 65 mg/1; mg/1; mg/1
46122-256_2a4b5cce-a3cd-4e96-be6d-f6ace758bbd9 46122-256 HUMAN OTC DRUG
Laxative pills maximum strength Sennosides TABLET ORAL 20140731
OTC MONOGRAPH NOT FINAL part334 AmerisourceBergen (Good Neighbor Pharmacy) 46122
SENNOSIDES 25 mg/1
46122-257_07f57d8e-e9dc-4aa7-b7de-65f2b2567f78 46122-257 HUMAN OTC DRUG
Pain Reliever Extra Strength Acetaminophen TABLET ORAL 20140501
46122-260_2e77e3f1-cb5a-4df7-96ea-b429b1fe0f8f 46122-260 HUMAN OTC DRUG
Stool Softener DOCUSATE CALCIUM "CAPSULE, LIQUID FILLED"
n (Good Neighbor Pharmacy) 46122 DOCUSATE CALCIUM 240 mg/1
46122-262_59ea330a-cf07-4e1f-9a31-0f5f2a9a9cce 46122-262 HUMAN OTC DRUG
ASPIRIN 81 mg/1
46122-263_4da6bbf6-e488-4602-918f-b9c05274e782 46122-263 HUMAN OTC DRUG
Stool Softener Extra Strength DOCUSATE SODIUM "CAPSULE, LIQUID FILLED"
n (Good Neighbor Pharmacy) 46122 DOCUSATE SODIUM 250 mg/1
46122-265_6a62dee0-4a75-4a78-9e84-ed16bc961cb9 46122-265 HUMAN OTC DRUG
Sore Throat Cherry Phenol SPRAY ORAL 20140731 OTC MONO
GRAPH NOT FINAL part356 AmerisourceBergen (Good Neighbor Pharmacy) 46122
PHENOL 1.4 g/100mL
24385-026_b0a9862d-b084-421e-9038-4a149ce14e30 24385-026 HUMAN OTC DRUG
Good Neighbor Pharmacy Mucus Relief DM Dextromethorphan Hydrobromide /
Guaifenesin TABLET ORAL 20120801 OTC MONOGRAPH FINAL
part341 AmerisourceBergen Drug Corp DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENES
IN 20; 400 mg/1; mg/1
24385-602_85ae77c0-f496-4839-8bf7-eb0e0e200979 24385-602 HUMAN OTC DRUG
Good Neighbor Pharmacy Mucus Relief Guaifenesin TABLET ORAL
20110915 OTC MONOGRAPH FINAL part341 AmerisourceBergen Drug C
orp GUAIFENESIN 400 mg/1
24385-925_19f17707-05ae-42cf-9b2b-f758ff44a62b 24385-925 HUMAN OTC DRUG
Good Neighbor Pharmacy Mucus Relief PE PE Guaifenesin/phenylephrine
TABLET ORAL 20060605 OTC MONOGRAPH FINAL part341 Amerisou
rceBergen Drug Corp GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 400; 10
mg/1; mg/1
46122-057_916c59ed-07ea-4e0b-a6c0-de357d78ee0e 46122-057 HUMAN OTC DRUG
Good Neighbor Pharmacy TabTussin Guaifenesin TABLET ORAL
orp GUAIFENESIN 400 mg/1
46122-058_3f97cc9d-4bdf-4862-8bcd-ff2f0ef62d2b 46122-058 HUMAN OTC DRUG
Good Neighbor Pharmacy Tab Tussin DM DMTDM Dextromethorphan Hydrobromide /
Guaifenesin TABLET ORAL 20120801 OTC MONOGRAPH FINAL
part341 AmerisourceBergen Drug Corp DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENES
IN 20; 400 mg/1; mg/1
46122-161_b8d093e5-e2b6-47bb-8c80-e0e33abfcb38 46122-161 HUMAN OTC DRUG
Good Neighbor Pharmacy Sodium Phosphate Enema ENEMA RECTAL 20130301
OTC MONOGRAPH NOT FINAL part334 AMERISOURCEBERGEN DRUG CORPORATION "SODIUM
PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC" 7; 19 g/118mL; g/118mL
46122-162_f75b3f9a-2d66-44fd-b617-36ab5e16e145 46122-162 HUMAN OTC DRUG
Good Neighbor Pharmacy Mineral Oil ENEMA RECTAL 20130301
OTC MONOGRAPH NOT FINAL part334 AMERISOURCEBERGEN DRUG CORPORATION MINERAL
OIL 118 mL/118mL
68084-079_21d73b96-9ca5-4959-91e7-c8536118a761 68084-079 HUMAN PRESCRIPTI
ANDA ANDA075350 AMERISOURCEBERGEN DRUG CORPORATION GABAPENTIN
68084-081_21d73b96-9ca5-4959-91e7-c8536118a761 68084-081 HUMAN PRESCRIPTI
ANDA ANDA075350 AMERISOURCEBERGEN DRUG CORPORATION GABAPENTIN
24385-499_51091b93-a39c-4098-a386-ae58dd413526 24385-499 HUMAN OTC DRUG
Ibuprofen softgels Ibuprofen "CAPSULE, LIQUID FILLED"
ORAL 20100708 ANDA ANDA078682 AmerisourceBergen Drug C
orporation (Good Neighbor Pharmacy) IBUPROFEN 200 mg/1
24385-676_2fcbd99a-70b9-4e41-b469-defc2aaa0e47 24385-676 HUMAN OTC DRUG
Good Neighbor Anti-Fungal Undecylenic acid LIQUID TOPICAL
20080801 OTC MONOGRAPH FINAL part333C AmerisourceBerge
n Drug Corporation (Good Neighbor Pharmacy) UNDECYLENIC ACID 250
mg/mL
24385-955_e9d8b71c-e35f-44fa-9542-d4d2278c9a7f 24385-955 HUMAN OTC DRUG
Ear Drops Earwax Removal Aid Carbamide Peroxide LIQUID TOPICAL
orporation (Good Neighbor Pharmacy) CARBAMIDE PEROXIDE 65 mg/mL
46122-030_d25d611e-ad01-4212-8f47-ec07cbcc43d0 46122-030 HUMAN OTC DRUG
Good Neighbor Pain Relief Benzocaine LIQUID ORAL 20080801
OTC MONOGRAPH NOT FINAL part356 AmerisourceBergen Drug Corporation (Good Neighbo
r Pharmacy) BENZOCAINE 200 mg/mL
24385-004_d4563b79-d812-494f-84dc-cf913b8ebf18 24385-004 HUMAN OTC DRUG
Motion Sickness Relief Dimenhydrinate TABLET ORAL 20100709
OTC MONOGRAPH FINAL part336 AmerisourceBergen Drug Corporation (Good Neighbo
r Pharmacy) 24385 DIMENHYDRINATE 50 mg/1
24385-013_fa417d3e-3384-469e-ba09-97da0656e498 24385-013 HUMAN OTC DRUG
Urinary Pain Relief Phenazopyridine Hydrochloride TABLET ORAL
20100708 UNAPPROVED DRUG OTHER AmerisourceBergen Drug C
orporation (Good Neighbor Pharmacy) 24385 PHENAZOPYRIDINE 95 mg/1
24385-193_71b39099-f102-419f-84c1-8e2c6d6d43ae 24385-193 HUMAN OTC DRUG
womens laxative Bisacodyl TABLET ORAL 20100715
OTC MONOGRAPH NOT FINAL part334 AmerisourceBergen Drug Corporation (Good Neighbo
r Pharmacy) 24385 BISACODYL 5 mg/1
24385-388_c164385f-37ed-40fd-8a22-8242c8daf399 24385-388 HUMAN OTC DRUG
Motion sickness Relief Meclizine Hydrochloride TABLET ORAL 20100709
r Pharmacy) 24385 MECLIZINE HYDROCHLORIDE 25 mg/1
24385-429_1957f9d8-2d1f-492c-8f6a-db312aba722b 24385-429 HUMAN OTC DRUG
Aspirin regular strength Aspirin "TABLET, COATED" ORAL 20111117
r Pharmacy) 24385 ASPIRIN 325 mg/1
24385-460_e445123e-23c7-46f5-bb5f-ee9537917d91 24385-460 HUMAN OTC DRUG
AntiGas ultra strength Simethicone "CAPSULE, LIQUID FILLED" ORAL
orporation (Good Neighbor Pharmacy) 24385 DIMETHICONE 180 mg/1
24385-903_45fcb168-ab4d-408f-a6f0-b4596be62fd3 24385-903 HUMAN OTC DRUG
Laxative Enteric Coated Bisacodyl "TABLET, COATED" ORAL
20111024 OTC MONOGRAPH NOT FINAL part334 AmerisourceBergen Drug C
orporation (Good Neighbor Pharmacy) 24385 BISACODYL 5 mg/1
24385-369_fe74f894-5335-4e15-8e15-a4614dc99829 24385-369 HUMAN OTC DRUG
Laxative pills maximum strength Sennosides TABLET ORAL 20100708
OTC MONOGRAPH NOT FINAL part334 Amerisourcebergen Drug Corporation (Good Neighbo
ur Pharmacy) SENNOSIDES 25 mg/1
24385-435_04f3a417-a543-4043-aaf1-e87f85fd1b7c 24385-435 HUMAN OTC DRUG
Docusate Calcium stool softener DOCUSATE CALCIUM "CAPSULE, LIQUID
FILLED" ORAL 20100712 OTC MONOGRAPH NOT FINAL part334
Amerisourcebergen Drug Corporation (Good Neighbour Pharmacy) DOCUSATE CALCIUM
240 mg/1
24385-436_2f3bbfce-d4ae-4fe2-a400-ad969bdb0baf 24385-436 HUMAN OTC DRUG
stool softener DOCUSATE SODIUM "CAPSULE, LIQUID FILLED" ORAL
20100708 OTC MONOGRAPH NOT FINAL part334 Amerisourcebergen Drug C
orporation (Good Neighbour Pharmacy) DOCUSATE SODIUM 100 mg/1
24385-443_19bf22b6-aa77-4b98-9894-ba0e0cf3ef40 24385-443 HUMAN OTC DRUG
STOOL SOFTENER EXTRA STRENGTH DOCUSATE SODIUM "CAPSULE, LIQUID FILLED"
ORAL 20100709 OTC MONOGRAPH NOT FINAL part334 Amerisourceberge
n Drug Corporation (Good Neighbour Pharmacy) DOCUSATE SODIUM 250 mg/1
24385-495_10783ab4-7091-4ade-94b4-324f717ec6a7 24385-495 HUMAN OTC DRUG
Stool Softener and Stimulant Laxative Docusate sodium and Sennosides
TABLET ORAL 20100709 OTC MONOGRAPH NOT FINAL part334 Amerisou
rcebergen Drug Corporation (Good Neighbour Pharmacy) DOCUSATE SODIUM; SENNOSI
DES 50; 8.6 mg/1; mg/1
24385-505_447879b9-e0fe-4f63-9765-c8e03b5c13da 24385-505 HUMAN OTC DRUG
Senna Plus docusate sodium and sennosides TABLET ORAL 20100715
OTC MONOGRAPH NOT FINAL part334 Amerisourcebergen Drug Corporation (Good Neighbo
ur Pharmacy) DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1
46122-157_95212d4b-7381-4f99-bc9c-c77a952d8742 46122-157 HUMAN OTC DRUG
Chest Rub "Camphor, Eucalyptus Oil, Menthol" JELLY TOPICAL
20090908 OTC MONOGRAPH FINAL part341 AmersourceBergen
CAMPHOR (NATURAL); EUCALYPTUS OIL; MENTHOL 4.8; 1.2; 2.6 kg/100kg; kg/100
kg; kg/100kg
55513-002_21d8e10c-945f-44e8-87c4-4a0882351273 55513-002 HUMAN PRESCRIPTI
ON DRUG ARANESP darbepoetin alfa SOLUTION INTRAVENOUS; SUB
CUTANEOUS 20060911 BLA BLA103951 Amgen Inc
DARBEPOETIN ALFA 25 ug/mL "Erythropoiesis-stimulating Agent [EPC],
Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE]"
ON DRUG ARANESP darbepoetin alfa "INJECTION, SOLUTION" INTRAVEN
OUS; SUBCUTANEOUS 20060814 BLA BLA103951 Amgen In
c DARBEPOETIN ALFA 40 ug/.4mL "Erythropoiesis-stimulating Agen
t [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production
[PE]"
[PE]"
[PE]"
[PE]"
[PE]"
c DARBEPOETIN ALFA 500 ug/mL "Erythropoiesis-stimulating Agen
[PE]"
DARBEPOETIN ALFA 150 ug/.75mL "Erythropoiesis-stimulating Agen
[PE]"
c DARBEPOETIN ALFA 25 ug/.42mL "Erythropoiesis-stimulat
ing Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Pr
oduction [PE]"
55513-073_2374d271-e5cf-4913-91e9-2c8d4f4c7cf5 55513-073 HUMAN PRESCRIPTI
ON DRUG Sensipar cinacalcet hydrochloride "TABLET, COATED"
ORAL 20040404 NDA NDA021688 Amgen Inc CINACALC
ET HYDROCHLORIDE 30 mg/1 "Calcium-sensing Receptor Agonist [EPC],
Increased Calcium-sensing Receptor Sensitivity [MoA]"
[PE]"
55513-126_4fc2d39d-2176-407d-b3bf-68151c32bf9f 55513-126 HUMAN PRESCRIPTI
ON DRUG EPOGEN epoetin alfa SOLUTION INTRAVENOUS; SUBCUTANEOU
S 19890630 BLA BLA103234 Amgen Inc ERYTHROP
OIETIN 2000 [iU]/mL "Erythropoiesis-stimulating Agent [EPC],Erythropoietin [
Chemical/Ingredient],Increased Erythroid Cell Production [PE]"
55513-190_777a44b9-d695-4679-8e40-50b791d89fe2 55513-190 HUMAN PRESCRIPTI
ON DRUG Neulasta pegfilgrastim INJECTION SUBCUTANEOUS
20020401 BLA BLA125031 Amgen Inc PEGFILGRASTIM
6 mg/.6mL "Granulocyte Colony-Stimulating Factor [Chemical/Ingredient],Gra
nulocyte-Macrophage Colony-Stimulating Factor [Chemical/Ingredient],Increased My
eloid Cell Production [PE],Leukocyte Growth Factor [EPC]"
55513-209_d95bd786-9c42-4c22-9f14-6a50ff1a2080 55513-209 HUMAN PRESCRIPTI
ON DRUG NEUPOGEN Filgrastim "INJECTION, SOLUTION" INTRAVEN
c FILGRASTIM 480 ug/.8mL "Granulocyte Colony-Stimulating Factor [
Chemical/Ingredient],Granulocyte-Macrophage Colony-Stimulating Factor [Chemical/
Ingredient],Increased Myeloid Cell Production [PE],Leukocyte Growth Factor [EPC]
"
55513-221_1a708aca-8b0c-4cd9-9f30-76501636d609 55513-221 HUMAN PRESCRIPTI
ON DRUG Nplate romiplostim "INJECTION, POWDER, LYOPHILIZED, FOR SOL
UTION" SUBCUTANEOUS 20080825 BLA BLA125268 Amgen In
c ROMIPLOSTIM 250 ug/.5mL "Increased Megakaryocyte Maturation [PE]
,Increased Platelet Production [PE],Thrombopoiesis Stimulating Agent [EPC],Throm
bopoietin Receptor Agonists [MoA],Thrombopoietin Receptor Interactions [MoA]"
55513-222_1a708aca-8b0c-4cd9-9f30-76501636d609 55513-222 HUMAN PRESCRIPTI
ON DRUG Nplate romiplostim "INJECTION, POWDER, LYOPHILIZED, FOR SOL
UTION" SUBCUTANEOUS 20080825 BLA BLA125268 Amgen In
c ROMIPLOSTIM 500 ug/mL "Increased Megakaryocyte Maturation [PE]
,Increased Platelet Production [PE],Thrombopoiesis Stimulating Agent [EPC],Throm
bopoietin Receptor Agonists [MoA],Thrombopoietin Receptor Interactions [MoA]"
c FILGRASTIM 300 ug/mL "Granulocyte Colony-Stimulating Factor [
"
c FILGRASTIM 480 ug/1.6mL "Granulocyte Colony-Stimulating
Factor [Chemical/Ingredient],Granulocyte-Macrophage Colony-Stimulating Factor [C
hemical/Ingredient],Increased Myeloid Cell Production [PE],Leukocyte Growth Fact
or [EPC]"
55513-710_f23bd1e9-1b2a-42ed-b6a9-2198cff4f659 55513-710 HUMAN PRESCRIPTI
ON DRUG Prolia denosumab INJECTION SUBCUTANEOUS 20100605
BLA BLA125320 Amgen Inc DENOSUMAB 60 mg/mL "RANK Li
gand Inhibitor [EPC],RANK Ligand Blocking Activity [MoA]"
55513-730_1b22c2b8-08eb-4b1c-899b-a73ba0060f21 55513-730 HUMAN PRESCRIPTI
ON DRUG XGEVA denosumab INJECTION SUBCUTANEOUS 20101118
BLA BLA125320 Amgen Inc DENOSUMAB 120 mg/1.7mL
"RANK Ligand Inhibitor [EPC],RANK Ligand Blocking Activity [MoA]"
c FILGRASTIM 300 ug/.5mL "Granulocyte Colony-Stimulating Factor [
"
55513-954_bf76ae32-7e97-4005-ab25-f38158deab84 55513-954 HUMAN PRESCRIPTI
ON DRUG Vectibix panitumumab SOLUTION INTRAVENOUS
20061010 BLA BLA125147 Amgen Inc PANITUMUMAB
100 mg/5mL Epidermal Growth Factor Receptor Antagonist [EPC]
59535-0011_239ae403-232a-4b4e-9659-48de110187f7 59535-0011 HUMAN OTC DRUG
Super Aqua Facial Foam Glycerin LIQUID TOPICAL 20140414
OTC MONOGRAPH FINAL part347 "AMI Cosmetic Co.,Ltd." GLYCERIN 0.16
g/mL
59535-0101_951e07d1-5c05-4774-b09a-48ed3859134f 59535-0101 HUMAN OTC DRUG
PROPOLIS 39 CC ZINC OXIDE CREAM TOPICAL 20130726
OTC MONOGRAPH FINAL part347 "AMI Cosmetic Co.,Ltd." ZINC OXIDE 0.0098
g/g
59535-0111_937168a5-22fb-49f9-a764-f0ad475f15c1 59535-0111 HUMAN OTC DRUG
Ultra Nutrition Night Glycerin CREAM TOPICAL 20140414
g/mL
59535-0201_6ccb1b45-8fcc-4b1b-b72f-ab1d2798c5ad 59535-0201 HUMAN OTC DRUG
ACTIVE RESURGENCE SERUM GLYCERIN LIQUID TOPICAL 20130801
mg/mL
59535-0301_56cc5a0a-812d-4897-ad87-5b2e53843733 59535-0301 HUMAN OTC DRUG
COLLAGEN RESURGENCE STEMCELL BB ZINC OXIDE CREAM TOPICAL 20130801
mg/g
59535-0401_4f80042c-6dcd-4750-a39a-35c0f8fd9fe2 59535-0401 HUMAN OTC DRUG
MAX HYALURONIC STEMCELL SLEEPING PACK GLYCERIN CREAM TOPICAL
20130831 OTC MONOGRAPH FINAL part347 "AMI Cosmetic Co.,Ltd."
GLYCERIN 0.02 g/mL
59535-0601_e173b195-9d36-432a-ac26-482e8714f34c 59535-0601 HUMAN OTC DRUG
Vitalizer Laser Aid BB Glycerin CREAM TOPICAL 20140414
g/g
59535-0701_13b3cdf9-1da0-4559-95c9-3710c582e750 59535-0701 HUMAN OTC DRUG
Blemish Toner Glycerin LIQUID TOPICAL 20140414
g/mL
59535-0801_dcd8acb4-7d7e-42a8-8031-0ab055cbb795 59535-0801 HUMAN OTC DRUG
Jasmine Eco Mist Glycerin LIQUID TOPICAL 20140414
g/mL
59535-0901_0c2ead9e-dffc-449a-9fb5-ec7b1a1135cd 59535-0901 HUMAN OTC DRUG
Pore Tightening Serum Glycerin LIQUID TOPICAL 20140414
g/mL
59535-1001_32549d52-3497-4283-82b2-77f4d7646f1a 59535-1001 HUMAN OTC DRUG
GOLD CAVIAR BB Zinc oxide CREAM TOPICAL 20130726
g/g
59535-1011_4f2ef720-be2b-4f6e-abc2-4dfd6d2192d9 59535-1011 HUMAN OTC DRUG
Super Aqua Toner Glycerin LIQUID TOPICAL 20140414
g/mL
59535-1021_6b11430e-8f06-485a-a1ef-38f5e7c7e8a5 59535-1021 HUMAN OTC DRUG
Super Aqua Ampoule Glycerin LIQUID TOPICAL 20140414
g/mL
59535-1031_21e976f5-0d89-41d0-87b1-7980acb81f03 59535-1031 HUMAN OTC DRUG
Super Aqua Day Glycerin CREAM TOPICAL 20140414
g/mL
59535-1041_0db2990d-545c-4d8e-9911-592a0d4f25d3 59535-1041 HUMAN OTC DRUG
Super Aqua Night Glycerin CREAM TOPICAL 20140414
g/mL
59535-1051_c1c7abf0-b87d-46a7-86bb-0e4025911c59 59535-1051 HUMAN OTC DRUG
Super Aqua Eye Glycerin CREAM TOPICAL 20140414
g/mL
59535-1071_2a50c24e-1a3d-4f00-9259-9693b1b8acdb 59535-1071 HUMAN OTC DRUG
Ultra Nutrition Toner Glycerin LIQUID TOPICAL 20140414
g/mL
59535-1081_8277aa7d-adee-493f-b895-3270f8dcff12 59535-1081 HUMAN OTC DRUG
Ultra Nutrition Ampoule Glycerin LIQUID TOPICAL 20140414
g/mL
59535-1091_b7d99f12-5848-42bb-b272-4d23bb633a0a 59535-1091 HUMAN OTC DRUG
Ultra Nutrition Day Glycerin LIQUID TOPICAL 20140414
g/mL
59535-1101_06f774af-85e5-4195-9db2-2e14eca8eb35 59535-1101 HUMAN OTC DRUG
Medskin Cleansing POLYSORBATE 20 OIL TOPICAL 20130801
UNAPPROVED DRUG OTHER "AMI Cosmetic Co.,Ltd." POLYSORBATE 20 0.21
mg/mL
59535-1111_d45266ad-86ce-4fd9-b1bd-6260d794b591 59535-1111 HUMAN OTC DRUG
Ultra Nutrition Eye Glycerin CREAM TOPICAL 20140414
g/mL
59535-1131_1ffba80e-2be0-4d95-b83f-8282256f80e5 59535-1131 HUMAN OTC DRUG
Intensive Vital Ampoule Glycerin LIQUID TOPICAL 20140414
g/mL
59535-1201_66aacc1f-141e-478f-9dd7-001b935cb38b 59535-1201 HUMAN OTC DRUG
ULTRA HYDRO FACIAL FOAM GLYCERIN LIQUID TOPICAL 20130831
g/mL
59535-1301_7ca5b273-2407-4689-bb7e-fb4f1a696944 59535-1301 HUMAN OTC DRUG
REVITALIZING FACIAL FOAM GLYCERIN LIQUID TOPICAL 20130831
g/mL
59535-1401_eb15dca5-3cfd-4e9f-9085-b7b089bbd017 59535-1401 HUMAN OTC DRUG
WHITENING LEMON PEEL CITRIC ACID MONOHYDRATE LIQUID TOPICAL 20130831
OTC MONOGRAPH FINAL part331 "AMI Cosmetic Co.,Ltd." CITRIC ACID MONOHYDRATE
0.007 g/mL
59535-1501_69b75e1d-1774-4a60-a3c7-99c02efbd431 59535-1501 HUMAN OTC DRUG
HERBAL STEMCELL AHA PEEL LACTIC ACID LIQUID TOPICAL 20130801
UNAPPROVED DRUG OTHER "AMI Cosmetic Co.,Ltd." LACTIC ACID 0.01
mg/mL
59535-1601_28cccdf1-0d40-48fc-9f50-28681ca00d20 59535-1601 HUMAN OTC DRUG
ACTIVE RESURGENCE TONER GLYCERIN LIQUID TOPICAL 20130801
mg/mL
59535-1701_9dfd3690-d585-4654-858d-1aeffe5d1550 59535-1701 HUMAN OTC DRUG
ULTRA HYDRA TONER GLYCERIN LIQUID TOPICAL 20130801
mg/mL
59535-1801_96923229-dc8e-4a76-a77d-fbaa303c2055 59535-1801 HUMAN OTC DRUG
REVITALIZING C TONER GLYCERIN LIQUID TOPICAL 20130801
mg/mL
59535-1901_8390faca-3bcf-448c-bbad-c39f75bed013 59535-1901 HUMAN OTC DRUG
ACTIVE RESURGENCE EYE GLYCERIN CREAM TOPICAL 20130801
mg/mL
59535-2001_1540b958-4006-4529-a4cd-03445faf75fb 59535-2001 HUMAN OTC DRUG
JASMINE WATER BB Zinc oxide CREAM TOPICAL 20130726
g/g
59535-2101_13944a2f-9cee-46f7-b103-63233db871f6 59535-2101 HUMAN OTC DRUG
ULTRA HYDRA SERUM GLYCERIN LIQUID TOPICAL 20130801
g/mL
59535-2201_89b25740-e113-48d4-a35b-c1c0e43b5737 59535-2201 HUMAN OTC DRUG
REVITALIZING C SERUM GLYCERIN LIQUID TOPICAL 20130831
g/mL
59535-2301_537bec62-fa94-4191-80bb-cf371d9dacfd 59535-2301 HUMAN OTC DRUG
COLLAGEN RESURGENCE LASER AMPOULE GLYCERIN LIQUID TOPICAL
GLYCERIN 0.04 mg/mL
59535-2401_ff9337dc-e6f1-4c02-88cd-794ce57afb58 59535-2401 HUMAN OTC DRUG
REVITALIZING C I2PL CORRECTOR AMPOULE GLYCERIN LIQUID TOPICAL
GLYCERIN 0.03 mg/mL
59535-2501_c5518bfa-5f70-474d-a72d-ba8018fe6901 59535-2501 HUMAN OTC DRUG
SEAWEED MEDICLEAR HEALER AMPOULE GLYCERIN LIQUID TOPICAL
GLYCERIN 0.018 mg/mL
59535-2601_6cf48362-1a3d-4335-b49b-795a9a9a19b6 59535-2601 HUMAN OTC DRUG
ACTIVE RESURGENCE GLYCERIN CREAM TOPICAL 20130801
g/g
59535-2701_d1c8cb89-1dd6-40d0-87d1-cb94d0496ad3 59535-2701 HUMAN OTC DRUG
ULTRA HYDRA GLYCERIN CREAM TOPICAL 20130801
g/g
59535-2801_500ac9c3-f77b-4ac8-be85-2e9663cfde2e 59535-2801 HUMAN OTC DRUG
REVITALIZING C GLYCERIN CREAM TOPICAL 20130801
g/g
59535-2901_51c6a2e4-fbf3-4df7-ac2c-f79c3a2de6e8 59535-2901 HUMAN OTC DRUG
MAX HYALURONIC UV STEMCELL SUN BLOCK GLYCERIN CREAM TOPICAL
GLYCERIN 0.00001 mg/mL
59535-3001_40541278-8e3c-4e97-94fb-c9010077ddb2 59535-3001 HUMAN OTC DRUG
JASMINE 3D WATERFUL 3D C.C Zinc oxide CREAM TOPICAL 20130726
g/g
59535-3011_bdb98f1e-ce10-46e0-913c-7c7b67e4ef7a 59535-3011 HUMAN OTC DRUG
JASMINE 3D WATERFUL CC Zinc oxide CREAM TOPICAL 20130726
g/g
59535-3101_ca38b6a4-a0b0-4f87-9f7a-e09e1259cc12 59535-3101 HUMAN OTC DRUG
REVITALIZING C I2PL STEMCELL BB ZINC OXIDE CREAM TOPICAL 20130801
mg/g
59535-3201_71357bb9-1b25-4997-a03d-1b8aa8e58ea1 59535-3201 HUMAN OTC DRUG
SEAWEED MEDICLEAR STEMCELL BB GLYCERIN CREAM TOPICAL 20130801
g/g
59535-3301_6bf0a4f6-fdd4-4a63-b7a4-48d834bcab01 59535-3301 HUMAN OTC DRUG
MEDICLEAR DUAL SPOT DAY and NIGHT GLYCERIN LIQUID TOPICAL
GLYCERIN 0.05 g/mL
59535-3311_a05fbb7b-4963-4f16-a506-6315b217e01a 59535-3311 HUMAN OTC DRUG
MEDICLEAR DUAL SPOT DAY and NIGHT GLYCERIN LIQUID TOPICAL
GLYCERIN 0.05 g/mL
59535-3401_60b2b1ae-3f80-4b4f-b492-d62ce529bca9 59535-3401 HUMAN OTC DRUG
GOLDEN BALL HEALER GLYCERIN LIQUID TOPICAL 20130801
mg/mL
59535-3501_224efa75-6c0e-45c9-8d99-607c4e0cd8e6 59535-3501 HUMAN OTC DRUG
SNAIL RECOVER HEALER GLYCERIN CREAM TOPICAL 20130801
mg/mL
59535-3601_c80cf794-b449-4bff-8071-4e950b7aefaf 59535-3601 HUMAN OTC DRUG
BLACK HEAD REMOVER PANTHENOL LIQUID TOPICAL 20130801
UNAPPROVED DRUG OTHER "AMI Cosmetic Co.,Ltd." PANTHENOL 0.002
mg/mL
59535-3701_4d4f182f-20f4-4088-a0fd-bd4cf46c96c2 59535-3701 HUMAN OTC DRUG
MULTI ACTION POWER GLYCERIN EMULSION TOPICAL 20130831
g/mL
59535-3801_87e3c031-0437-4256-8fef-b174a4ce15c5 59535-3801 HUMAN OTC DRUG
MULTI ACTION BALANCING TONER GLYCERIN LIQUID TOPICAL 20130831
g/mL
59535-3901_e511ca99-7f90-4499-a136-ff4d10bc31a8 59535-3901 HUMAN OTC DRUG
MAX HYALURONIC STEMCELL EYE GLYCERIN CREAM TOPICAL 20130831
g/mL
59535-4001_d2d214ae-8940-420a-884b-e0da0cd54a83 59535-4001 HUMAN OTC DRUG
BRIGHT EYE VITALIZER DIMETHICONE STICK TOPICAL 20130726
OTC MONOGRAPH FINAL part347 "AMI Cosmetic Co.,Ltd." DIMETHICONE 0.01
g/g
59535-4101_1703580f-3cdf-46f5-b3a3-b8a452926ddc 59535-4101 HUMAN OTC DRUG
SUPREME 1ST ESSENCE ALLANTOIN LIQUID TOPICAL 20130801
OTC MONOGRAPH FINAL part347 "AMI Cosmetic Co.,Ltd." ALLANTOIN 0.002
mg/mL
59535-4201_cdfec46a-5e01-4b98-aa45-ab18906455a3 59535-4201 HUMAN OTC DRUG
V SHAPING AMPOULE GLYCERIN LIQUID TOPICAL 20130801
mg/mL
59535-4301_c073b801-9a36-4131-aac7-fd66efb52e8d 59535-4301 HUMAN OTC DRUG
COLLAGEN RESURGENCE MASK GLYCERIN LIQUID TOPICAL 20130801
g/g
59535-4311_3da48f12-bf12-4461-a34d-c58f477070ca 59535-4311 HUMAN OTC DRUG
COLLAGEN RESURGENCE MASK GLYCERIN LIQUID TOPICAL 20130801
g/g
59535-4401_cdc5f742-16f9-4f70-9d24-7d853d163c9b 59535-4401 HUMAN OTC DRUG
MAX HYALURONIC MASK GLYCERIN LIQUID TOPICAL 20130801
g/g
59535-4411_00de3be6-69d4-4be6-99cb-58958c31394a 59535-4411 HUMAN OTC DRUG
MAX HYALURONIC MASK GLYCERIN LIQUID TOPICAL 20130801
g/g
59535-4501_faf9d1ca-33e6-4268-8f19-2330878b2cd0 59535-4501 HUMAN OTC DRUG
REVITALIZING C I2PL MASK GLYCERIN LIQUID TOPICAL 20130801
g/g
59535-4511_9f20ca0f-ec1e-4b65-84b8-fffe2b9306c7 59535-4511 HUMAN OTC DRUG
REVITALIZING C I2PL MASK GLYCERIN LIQUID TOPICAL 20130801
g/g
59535-4601_2204cb8d-26e2-4c96-acef-cb10f34b9394 59535-4601 HUMAN OTC DRUG
SEAWEED MEDICLEAR MASK GLYCERIN LIQUID TOPICAL 20130801
g/g
59535-4611_c32865db-3423-4f66-8cf1-7a9ab5919af5 59535-4611 HUMAN OTC DRUG
SEAWEED MEDICLEAR MASK GLYCERIN LIQUID TOPICAL 20130907
g/g
59535-4701_f3890438-e7c6-41a4-9c0a-9e2c92d355ac 59535-4701 HUMAN OTC DRUG
CLIV Barrier Power Ampoule GLYCERIN LIQUID TOPICAL 20140306
g/mL
59535-4801_4f0fe89b-472d-40ba-acdb-de27b38f6481 59535-4801 HUMAN OTC DRUG
CLIV Barrier Power GLYCERIN CREAM TOPICAL 20140306
g/mL
59535-4911_1467507a-ee16-4445-bca1-be201c16ee0f 59535-4911 HUMAN OTC DRUG
CLIV Barrier Power GLYCERIN LOTION TOPICAL 20140306
g/mL
59535-5001_0496befb-f2f0-431f-b915-6f40142eb96e 59535-5001 HUMAN OTC DRUG
OVERNIGHT PORE TIGHTENER DIMETHICONE GEL TOPICAL 20130726
g/mL
59535-5011_350f0e3f-0393-406b-b5fe-014c5a90799c 59535-5011 HUMAN OTC DRUG
CLIV Ginseng Berry Premium Ampoule GLYCERIN LIQUID TOPICAL
GLYCERIN 0.04 g/mL
59535-5101_52cce31a-67b2-46f0-87d4-ad5d4ab6069d 59535-5101 HUMAN OTC DRUG
CLIV Ginseng Berry Premium GLYCERIN CREAM TOPICAL 20140306
g/mL
59535-5201_42db4e22-f8e5-49d8-b9df-e8f9a1ae284d 59535-5201 HUMAN OTC DRUG
CLIV Ginseng Berry Premium Eye GLYCERIN CREAM TOPICAL 20140306
g/mL
59535-5301_d47da0f2-c454-4f74-a2e2-8b6ce08f19ff 59535-5301 HUMAN OTC DRUG
Gold Caviar Cover Cushion Zinc oxide POWDER TOPICAL 20140414
g/g
59535-5401_2b10274c-4ab0-4a44-94f8-800fb1e3cb7c 59535-5401 HUMAN OTC DRUG
The First Ampoule Essence Allantoin CREAM TOPICAL 20140414
g/g
59535-5501_ed60a2e8-3521-497a-9a33-edcea860eb80 59535-5501 HUMAN OTC DRUG
The First Ampoule Essence BB Glycerin CREAM TOPICAL 20140414
g/g
59535-5601_22db5dcd-0856-4a0f-9114-c337bfa96aeb 59535-5601 HUMAN OTC DRUG
Medi Stem Eye Glycerin CREAM TOPICAL 20140414
g/mL
59535-5701_f4d29336-91b8-46fe-b46c-b82091c1feeb 59535-5701 HUMAN OTC DRUG
Medi Stem Collagen Ampoule Glycerin LIQUID TOPICAL 20140414
g/mL
59535-5801_c42f8a05-65cf-4780-8f0e-c40f8d871671 59535-5801 HUMAN OTC DRUG
Medi Stem Collagen Glycerin CREAM TOPICAL 20140414
g/mL
59535-5901_a16f28a9-5970-4799-b6ed-60578ffc5ed8 59535-5901 HUMAN OTC DRUG
Medi Stem Collagen Toner Glycerin LIQUID TOPICAL 20140414
g/mL
59535-6001_20e6064d-ddb9-484e-8303-ae1e6b2e1ce8 59535-6001 HUMAN OTC DRUG
BLEMISH RECOVER BALM DIMETHICONE CREAM TOPICAL 20130726
g/mL
59535-6101_e36dcec6-e421-48ce-bf35-f3251767f85d 59535-6101 HUMAN OTC DRUG
Vitalizer Glycerin CREAM TOPICAL 20140414
g/mL
59535-6201_4440f8d5-e9f4-4346-88ea-69c6ac5a56bc 59535-6201 HUMAN OTC DRUG
Vitalizer Fluid Allantoin LIQUID TOPICAL 20140414
g/mL
59535-6301_4bcee347-7267-48e9-a27a-18a2feec1134 59535-6301 HUMAN OTC DRUG
Vitalizer White DEXPANTHENOL LIQUID TOPICAL 20140414
OTC MONOGRAPH NOT FINAL part347 "AMI Cosmetic Co.,Ltd." DEXPANTHENOL 0.0005
g/mL
59535-6401_3c9604ad-5480-4683-8ba0-1169ef0a6f6b 59535-6401 HUMAN OTC DRUG
Vitalizer White Glycerin GEL TOPICAL 20140414
g/mL
59535-6501_2e0bcad4-c291-439d-89ce-4a431941f42f 59535-6501 HUMAN OTC DRUG
Vitalizer C10 Ampoule Glycerin LIQUID TOPICAL 20140414
g/mL
59535-6601_730a9477-21b1-48c7-a95a-6135312fedd4 59535-6601 HUMAN OTC DRUG
Bubble Refining Cleanser Glycerin LIQUID TOPICAL 20140414
g/mL
59535-6701_290d9952-5acf-4ae5-ae68-2905aa337da5 59535-6701 HUMAN OTC DRUG
Blemish Serum Glycerin LIQUID TOPICAL 20140414
g/mL
59535-6801_a0498c6f-8dc3-4ecc-8e68-73f65b20f16d 59535-6801 HUMAN OTC DRUG
Blemish Soothing Moisturizer Glycerin CREAM TOPICAL 20140414
g/mL
59535-6901_007c4576-5b4e-4c8c-9aac-10d6d2af92bf 59535-6901 HUMAN OTC DRUG
Blemish Allantoin LIQUID TOPICAL 20140414 OTC MONO
GRAPH FINAL part347 "AMI Cosmetic Co.,Ltd." ALLANTOIN 0.0005 g/mL
59535-7001_08f5eaf7-c280-48b2-95b5-027827f558ee 59535-7001 HUMAN OTC DRUG
MAX HYALURONIC FORMULA AMPOULE GLYCERIN LIQUID TOPICAL 20130726
g/mL
59535-7101_3137afdf-4d20-45b3-a974-26516704f5b1 59535-7101 HUMAN OTC DRUG
Blemish Potion Glycerin LIQUID TOPICAL 20140414
g/mL
59535-7201_d26b16e9-32c4-45a4-acf6-78df7a5c464d 59535-7201 HUMAN OTC DRUG
Aqua Rush Serum Glycerin LIQUID TOPICAL 20140414
g/mL
59535-7301_6da39c10-134c-4a25-b2fa-f3260c2a1a14 59535-7301 HUMAN OTC DRUG
Aqua Rush Water Drop BB TITANIUM DIOXIDE CREAM TOPICAL 20140414
OTC MONOGRAPH NOT FINAL part352 "AMI Cosmetic Co.,Ltd." TITANIUM DIOXIDE
0.0934 g/g
59535-7401_c9b9a0e2-41a7-4e68-8e78-e5de46c6ea74 59535-7401 HUMAN OTC DRUG
Aqua Rush Glycerin CREAM TOPICAL 20140414
g/mL
59535-7501_3ad3193d-ee11-418d-bfad-06373d320fb1 59535-7501 HUMAN OTC DRUG
Aqua Rush Fluid Allantoin LIQUID TOPICAL 20140414
g/mL
59535-7601_da2d3b69-3632-495f-952b-b674369f0cfd 59535-7601 HUMAN OTC DRUG
Aqua Rush Cover Cushion Glycerin POWDER TOPICAL 20140414
7 g/g
59535-7701_7d0bbecc-edc1-4ffa-8fe7-291d4bac6384 59535-7701 HUMAN OTC DRUG
Jasmine 3D Moist Glycerin POWDER TOPICAL 20140414
g/g
59535-7801_6acbdcc5-5341-4602-8f04-3a7d18e8da5a 59535-7801 HUMAN OTC DRUG
Jasmine 3D Moist Pact Allantoin POWDER TOPICAL 20140414
g/g
59535-7901_3588538e-1c7c-4811-8d42-4187658e5c51 59535-7901 HUMAN OTC DRUG
Jasmine 3D Whipping Essence Glycerin LIQUID TOPICAL 20140414
g/mL
59535-8001_c5637e58-3393-41a8-8480-d1a337df5b51 59535-8001 HUMAN OTC DRUG
MAX HYALURONIC STEMCELL BB ZINC OXIDE CREAM TOPICAL 20130726
g/g
59535-8101_5ab251f2-f70e-458d-b848-bf3d3f640019 59535-8101 HUMAN OTC DRUG
Jasmine Water Cover Cushion Zinc oxide LIQUID TOPICAL 20140414
g/g
59535-8201_b234b3df-73ee-430a-a45b-021ab82003c8 59535-8201 HUMAN OTC DRUG
Ginseng Stemcell Mask Glycerin LIQUID TOPICAL 20140414
g/g
59535-8301_f38aeb8c-e73e-4496-a650-37e717ddc0cb 59535-8301 HUMAN OTC DRUG
Power Aqua Balancing Toner Allantoin LIQUID TOPICAL 20140414
g/mL
59535-8401_df53dd9a-e323-455a-93fa-da7c2a025755 59535-8401 HUMAN OTC DRUG
Power Defence Smart Allantoin EMULSION TOPICAL 20140414
g/mL
59535-8501_ac5fdfc8-8cda-482c-9450-67521dcb6073 59535-8501 HUMAN OTC DRUG
Perfect Calming BB Remover Allantoin LIQUID TOPICAL 20140414
g/mL
59535-8601_849b1f26-1728-4dbf-b92f-4f328fd93347 59535-8601 HUMAN OTC DRUG
Perfect Calming Serum Allantoin LIQUID TOPICAL 20140414
g/mL
59535-8701_d7330022-eb1b-4b2a-8a76-3155a76cb541 59535-8701 HUMAN OTC DRUG
Perfect Calming Glycerin CREAM TOPICAL 20140414
g/mL
59535-8801_04548753-7e03-4e47-9c61-e6e1f76fade6 59535-8801 HUMAN OTC DRUG
Perfect Calming Toner Glycerin LIQUID TOPICAL 20140414
g/mL
59535-8901_8931c7e6-526b-4c2f-b5a0-e3b94d526857 59535-8901 HUMAN OTC DRUG
Perfect Pore Clean I DEXPANTHENOL LIQUID TOPICAL 20140414
OTC MONOGRAPH NOT FINAL part347 "AMI Cosmetic Co.,Ltd." DEXPANTHENOL 0.001
g/mL
59535-9001_6e65fb17-4e15-4759-b71b-ca87a1e021e3 59535-9001 HUMAN OTC DRUG
PROPOLIS 90 AMPOULE ZINC OXIDE LIQUID TOPICAL 20130726
g/mL
59535-9101_a9eb61ab-fde6-46a6-a055-a310e308952c 59535-9101 HUMAN OTC DRUG
Whitening Repairing BB Allantoin CREAM TOPICAL 20140414
g/g
59535-9201_6aea9620-a389-4ec3-8ce5-4f6f139920d8 59535-9201 HUMAN OTC DRUG
Whitening Repairing Cover Cushion Allantoin POWDER TOPICAL
ALLANTOIN 0.0001 g/g
59535-9301_65fe35b6-c7ff-4e38-8235-20a0c5104cae 59535-9301 HUMAN OTC DRUG
Vitamin A Velvet Mask Glycerin LIQUID TOPICAL 20140414
g/g
59535-9401_713fa36d-6493-4ec6-bbbf-18ff6f8576fb 59535-9401 HUMAN OTC DRUG
Vitamin B5 Velvet Mask Glycerin LIQUID TOPICAL 20140414
g/g
59535-9501_99b21ac7-60c5-4363-b0a4-66ab42592cc5 59535-9501 HUMAN OTC DRUG
Vitamin C Velvet Mask Glycerin LIQUID TOPICAL 20140414
g/g
59535-9601_5814bfb4-09d7-4969-b7a6-e06f3bfe3632 59535-9601 HUMAN OTC DRUG
Vitamin E Velvet Mask Glycerin LIQUID TOPICAL 20140414
g/g
59535-9701_3ae3bc63-5a6b-45d2-86dd-65ed03ad1f98 59535-9701 HUMAN OTC DRUG
Vitamin F Velvet Mask Glycerin LIQUID TOPICAL 20140414
g/g
59535-9801_5311175c-7e6c-4563-b72b-f741989cb7c8 59535-9801 HUMAN OTC DRUG
Vitamin H Velvet Mask Glycerin LIQUID TOPICAL 20140414
g/g
59535-9901_1ae858e1-85c1-49f4-85e8-e8e3f67e22c2 59535-9901 HUMAN OTC DRUG
Super Aqua Cleansing Oil Glycerin LIQUID TOPICAL 20140414
g/mL
51290-011_6b58da56-8aba-4b5a-8d23-f026a9715f32 51290-011 HUMAN OTC DRUG
Medaclear zinc pyrithione SHAMPOO TOPICAL 20100908
OTC MONOGRAPH FINAL part358H "Amico Educational Concepts, Inc."
PYRITHIONE ZINC 15 g/L
62212-252_62527732-b1ec-4728-a30e-a4b09341a39f 62212-252 HUMAN OTC DRUG
Menthol Amish Origins Medicated CREAM TOPICAL 20130101
OTC MONOGRAPH NOT FINAL part348 Amish Origins LLC MENTHOL 8 g/100g
51312-065_caab51b5-7536-4a0f-8f74-4b4f091cf4c7 51312-065 HUMAN PRESCRIPTI
ON DRUG oxygen oxygen GAS RESPIRATORY (INHALATION) 20100915
UNAPPROVED MEDICAL GAS "AmMed, Inc." OXYGEN 995 mL/100L
53746-111_072eddcc-9083-4cdf-8043-4cb879520be8 53746-111 HUMAN PRESCRIPTI
ANDA040729 Amneal Pharmaceuticals ACETAMINOPHEN; HYDROCODONE BITARTRATE
500; 5 mg/1; mg/1 "Opioid Agonist [EPC],Opioid Agonists [MoA]" CIII
53746-112_66641966-38a7-494e-84fb-c034de62b3d5 53746-112 HUMAN PRESCRIPTI
ON DRUG Hydrocodone Bitartrate and Acetaminophen Tablets Hydrocod
one Bitartrate and Acetaminophen TABLET ORAL 20100218
ANDA ANDA040748 Amneal Pharmaceuticals ACETAMINOPHEN; HYDROCODONE BITAR
oA]" CIII
53746-113_8913aa94-2f14-47fd-9961-aab4ce5d4d86 53746-113 HUMAN PRESCRIPTI
oA]" CIII
53746-114_fa93a101-a83f-4fac-802a-8f77cb09310e 53746-114 HUMAN PRESCRIPTI
CIII
53746-119_f3952177-9c58-4f5e-9d9a-b3d3e187e28f 53746-119 HUMAN PRESCRIPTI
53746-142_2d748080-2d3f-4208-8435-0bcab549ffd5 53746-142 HUMAN OTC DRUG
Ibuprofen (NSAID) Pain Releiver/ Fever Reducer Ibuprofen TABLET
ORAL 20091216 ANDA ANDA072199 Amneal Pharmaceuticals
IBUPROFEN 200 mg/1
53746-144_2d748080-2d3f-4208-8435-0bcab549ffd5 53746-144 HUMAN OTC DRUG
Ibuprofen (NSAID) Pain Releiver/ Fever Reducer Ibuprofen TABLET
IBUPROFEN 200 mg/1
53746-178_37996a6b-0ec4-4413-900d-d0dfee08be17 53746-178 HUMAN PRESCRIPTI
D RELEASE" ORAL 20091202 ANDA ANDA078596 Amneal P
harmaceuticals METFORMIN HYDROCHLORIDE 500 mg/1 "Biguanide [EPC],Biguani
des [Chemical/Ingredient]"
53746-179_37996a6b-0ec4-4413-900d-d0dfee08be17 53746-179 HUMAN PRESCRIPTI
D RELEASE" ORAL 20100226 ANDA ANDA078596 Amneal P
harmaceuticals METFORMIN HYDROCHLORIDE 750 mg/1 "Biguanide [EPC],Biguani
53746-188_d80e04c4-c055-476c-acff-843eb89366d2 53746-188 HUMAN PRESCRIPTI
ANDA ANDA075927 Amneal Pharmaceuticals NAPROXEN 250 mg/1
53746-191_91f51db3-1369-49b1-b785-18e55a23dab4 53746-191 HUMAN OTC DRUG
Naproxen Sodium (NSAID) Fever Reducer/ Pain Reliever Naproxen Sodium TABLET
53746-192_91f51db3-1369-49b1-b785-18e55a23dab4 53746-192 HUMAN OTC DRUG
Naproxen Sodium (NSAID) Fever Reducer/ Pain Reliever Naproxen Sodium TABLET
53746-193_0dd2d4b5-c4bf-4934-810d-11e6f18ece4b 53746-193 HUMAN PRESCRIPTI
ANDA ANDA078432 Amneal Pharmaceuticals NAPROXEN SODIUM 275 mg/1
53746-194_0dd2d4b5-c4bf-4934-810d-11e6f18ece4b 53746-194 HUMAN PRESCRIPTI
ANDA ANDA078432 Amneal Pharmaceuticals NAPROXEN SODIUM 550 mg/1
53746-253_ec6f6afd-d64b-4607-936a-77d04370edcb 53746-253 HUMAN PRESCRIPTI
ANDA ANDA077824 Amneal Pharmaceuticals RANITIDINE HYDROCHLORIDE
tagonist [EPC]"
53746-254_ec6f6afd-d64b-4607-936a-77d04370edcb 53746-254 HUMAN PRESCRIPTI
tagonist [EPC]"
65162-003_e058980d-ea54-4119-9a15-47b460c90445 65162-003 HUMAN OTC DRUG
Cetirizine Hydrochloride Cetirizine SOLUTION ORAL
20091007 ANDA ANDA090765 Amneal Pharmaceuticals CETIRIZI
65162-005_966b06b8-782d-437c-9bdb-3aec48f57dc8 65162-005 HUMAN OTC DRUG
Cetirizine Hydrochloride Cetirizine SOLUTION ORAL
65162-006_e0a50b3b-b519-47e3-872d-223d64171fa9 65162-006 HUMAN PRESCRIPTI
20100621 ANDA ANDA078477 Amneal Pharmaceuticals AMLODIPI
NE BESYLATE 2.5 mg/1 "Calcium Channel Antagonists [MoA],Dihydropyridi
65162-045_118c2ce0-2573-4de8-861a-3da2bb79e97a 65162-045 HUMAN OTC DRUG
Cetirizine Hydrochloride Cetirizine TABLET ORAL 20100121
ANDA ANDA078780 Amneal Pharmaceuticals CETIRIZINE HYDROCHLORIDE
5 mg/1
65162-046_4061bbde-90e8-446f-b2d9-678879549866 65162-046 HUMAN OTC DRUG
Cetirizine Hydrochloride Cetirizine TABLET ORAL 20100121
ANDA ANDA078780 Amneal Pharmaceuticals CETIRIZINE HYDROCHLORIDE
10 mg/1
65162-120_9ad84173-f61f-4248-9eba-ebdb514c960c 65162-120 HUMAN PRESCRIPTI
65162-145_be2bac86-6f22-471d-a517-c7b7a6e5995b 65162-145 HUMAN OTC DRUG
Cetirizine Hydrochloride Hives Relief Cetirizine TABLET ORAL
65162-146_36129c76-bfc7-4f3f-89bd-935bf221f9d6 65162-146 HUMAN OTC DRUG
Cetirizine Hydrochloride Hives Relief Cetirizine TABLET ORAL
65162-174_6fc4d215-86ac-416e-8e9a-5f84b78ef2db 65162-174 HUMAN PRESCRIPTI
ON DRUG Metformin Hydrochloride Metformin TABLET ORAL 20090601
ANDA ANDA077880 Amneal Pharmaceuticals METFORMIN HYDROCHLORIDE 850
mg/1 "Biguanide [EPC],Biguanides [Chemical/Ingredient]"
65162-350_f7a2bc2d-1734-4b7f-a380-0f6bc34d9cee 65162-350 HUMAN OTC DRUG
OTC MONOGRAPH FINAL part343 Amneal Pharmaceuticals ACETAMINOPHEN 325
mg/1
65162-356_bff016c0-424c-4fef-b2de-01412562470b 65162-356 HUMAN OTC DRUG
Ibuprofen Pain Reliever/Fever Reducer Ibuprofen "CAPSULE, LIQUID
FILLED" ORAL 20130329 ANDA ANDA202300 Amneal P
harmaceuticals IBUPROFEN 200 mg/1
65162-475_cd236b39-3da0-4afc-8196-95e7894eca1d 65162-475 HUMAN PRESCRIPTI
ON DRUG Norethindrone Acetate Norethindrone TABLET ORAL 20090701
ANDA ANDA200275 Amneal Pharmaceuticals NORETHINDRONE ACETATE 5
mg/1 "Progesterone Congeners [Chemical/Ingredient],Progestin [EPC]"
65162-506_b9359230-3e72-4127-addf-2a4189330008 65162-506 HUMAN PRESCRIPTI
INDOMETHACIN 75 mg/1 "Cyclooxygenase Inhibitors [MoA],Nonsteroidal An
rug [EPC]"
65162-512_401aea08-edcc-4beb-9d8c-aa37245338b8 65162-512 HUMAN PRESCRIPTI
UNAPPROVED DRUG OTHER Amneal Pharmaceuticals SALSALATE 500
mg/1
65162-513_401aea08-edcc-4beb-9d8c-aa37245338b8 65162-513 HUMAN PRESCRIPTI
UNAPPROVED DRUG OTHER Amneal Pharmaceuticals SALSALATE 750
mg/1
65162-517_32b5816d-7c22-4023-a245-b4e5b4f8cade 65162-517 HUMAN PRESCRIPTI
20110201 UNAPPROVED DRUG OTHER Amneal Pharmaceuticals
PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1
65162-520_32b5816d-7c22-4023-a245-b4e5b4f8cade 65162-520 HUMAN PRESCRIPTI
20110201 UNAPPROVED DRUG OTHER Amneal Pharmaceuticals
PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1
65162-521_d4c70548-9696-4e44-9e91-133948ad1e6a 65162-521 HUMAN PRESCRIPTI
TABLET ORAL 20110303 ANDA ANDA091179 Amneal Pharmaceu
ticals PROMETHAZINE HYDROCHLORIDE 25 mg/1 "Phenothiazine [EPC],Phe
nothiazines [Chemical/Ingredient]"
ticals PROMETHAZINE HYDROCHLORIDE 50 mg/1 "Phenothiazine [EPC],Phe
65162-541_8af4c089-8d97-445c-ba90-d45ab268979f 65162-541 HUMAN PRESCRIPTI
ticals CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 "Centrally-mediated Musc
le Relaxation [PE],Muscle Relaxant [EPC]"
65162-542_e58924cd-e819-4527-9101-d181aa4882f0 65162-542 HUMAN PRESCRIPTI
ON DRUG Potassium Chloride Potassium Chloride "CAPSULE, EXTEND
ED RELEASE" ORAL 20130222 ANDA ANDA202128 Amneal P
harmaceuticals POTASSIUM CHLORIDE 750 mg/1 "Potassium Compounds [Ch
emical/Ingredient],Potassium Salt [EPC]"
65162-544_36e4a4a6-d51a-4806-9d41-df0bfeb0d7c7 65162-544 HUMAN PRESCRIPTI
ANDA ANDA040866 Amneal Pharmaceuticals PRIMIDONE 50 mg/1
ical Activity [PE]"
65162-545_36e4a4a6-d51a-4806-9d41-df0bfeb0d7c7 65162-545 HUMAN PRESCRIPTI
ANDA ANDA040866 Amneal Pharmaceuticals PRIMIDONE 250 mg/1
ical Activity [PE]"
65162-554_8849f977-0448-4a3e-bd96-ee1b8791fefa 65162-554 HUMAN PRESCRIPTI
ticals DEMECLOCYCLINE HYDROCHLORIDE 150 mg/1 "Tetracycline-class Anti
microbial [EPC],Tetracyclines [Chemical/Ingredient]"
65162-555_8849f977-0448-4a3e-bd96-ee1b8791fefa 65162-555 HUMAN PRESCRIPTI
ticals DEMECLOCYCLINE HYDROCHLORIDE 300 mg/1 "Tetracycline-class Anti
microbial [EPC],Tetracyclines [Chemical/Ingredient]"
65162-571_430b6506-6c55-46de-a99b-e0d980eadc96 65162-571 HUMAN PRESCRIPTI
ON DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL
20100401 ANDA ANDA040855 Amneal Pharmaceuticals BETHANEC
HOL CHLORIDE 5 mg/1 "Cholinergic Muscarinic Agonist [EPC],Cholinergi
c Muscarinic Agonists [MoA]"
65162-602_32b048b0-47ce-472a-9c95-2d3d7213a456 65162-602 HUMAN OTC DRUG
Acetaminophen Extra Strength Acetaminophen TABLET ORAL 20091216
mg/1
65162-607_32b048b0-47ce-472a-9c95-2d3d7213a456 65162-607 HUMAN OTC DRUG
Acetaminophen Extra Strength Acetaminophen TABLET ORAL 20091216
mg/1
65162-649_d3ce4084-545d-410c-88d4-e27c4b018fd4 65162-649 HUMAN PRESCRIPTI
ON DRUG Oxcarbazepine Oxcarbazepine SUSPENSION ORAL 20120604
ANDA ANDA202961 Amneal Pharmaceuticals OXCARBAZEPINE 300 mg/5mL
ical Activity [PE]"
65162-659_8cb170bc-f539-4d27-9133-47a956ecf21c 65162-659 HUMAN PRESCRIPTI
ON DRUG Nizatidine Nizatidine SOLUTION ORAL 20091214
ANDA ANDA090576 Amneal Pharmaceuticals NIZATIDINE 15 mg/mL
"Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]"
65162-664_baf8cc8b-1e88-4214-b4f3-9562e41bb621 65162-664 HUMAN PRESCRIPTI
tagonist [EPC]"
65162-667_42511615-d934-499c-afdf-f8d06da29d7f 65162-667 HUMAN PRESCRIPTI
ON DRUG Prednisolone Sodium Phosphate Prednisolone Sodium Phosphate
SOLUTION ORAL 20091201 ANDA ANDA078345 Amneal P
harmaceuticals PREDNISOLONE SODIUM PHOSPHATE 15 mg/5mL "Corticosteroid
65162-672_010ab916-bc42-4e69-85d6-6585fc34226d 65162-672 HUMAN OTC DRUG
Ibuprofen Pain Reliever/ Fever Reducer Ibuprofen SUSPENSION
65162-673_6d47971f-bd0e-42f2-82d3-5c8342e0c65c 65162-673 HUMAN PRESCRIPTI
ON DRUG Risperidone Risperidone SOLUTION ORAL 20110531
ANDA ANDA091384 Amneal Pharmaceuticals RISPERIDONE 1 mg/mL
65162-679_ee90bcbe-e00d-471d-a67d-c76219081527 65162-679 HUMAN PRESCRIPTI
ON DRUG Promethazine Hydrochloride and Phenylephrine Hydrochloride
Promethazine and Phenylephrine SOLUTION ORAL 20090825
ANDA ANDA040902 Amneal Pharmaceuticals PHENYLEPHRINE HYDROCHLORIDE; PRO
METHAZINE HYDROCHLORIDE 5; 6.25 mg/5mL; mg/5mL "Phenothiazine [EPC],Phenothiazi
nes [Chemical/Ingredient],alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Ago
nists [MoA]"
65162-680_9fdb590d-9632-4db0-a1c7-f4ffb22dfc70 65162-680 HUMAN PRESCRIPTI
ON DRUG Promethazine Hydrochloride and Dextomethorphan Hydrobromide
Promethazine Hydrochloride and Dextomethorphan Hydrobromide SOLUTION
DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE 15; 6.25
mg/5mL; mg/5mL "Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Uncomp
etitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Unc
ompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA]"
65162-684_b91292b2-51dd-4bbc-ad96-c2adc0314243 65162-684 HUMAN PRESCRIPTI
ON DRUG Cetirizine Hydrochloride Cetirizine SOLUTION
CETIRIZINE HYDROCHLORIDE 5 mg/5mL "Histamine H1 Receptor Antagonis
65162-686_8e2ca93c-0426-45a9-8520-ddadafef6672 65162-686 HUMAN PRESCRIPTI
ON DRUG Felbamate Felbamate SUSPENSION ORAL 20111216
ANDA ANDA202385 Amneal Pharmaceuticals FELBAMATE 600 mg/5mL
ical Activity [PE]"
65162-711_042bf3b6-8c88-4b30-b034-0f4ca1b8e8ea 65162-711 HUMAN PRESCRIPTI
ticals GUANFACINE HYDROCHLORIDE 1 mg/1 "Adrenergic alpha2-Agoni
65162-713_042bf3b6-8c88-4b30-b034-0f4ca1b8e8ea 65162-713 HUMAN PRESCRIPTI
ticals GUANFACINE HYDROCHLORIDE 2 mg/1 "Adrenergic alpha2-Agoni
65162-734_95dbc5f9-1253-4164-ad97-62249b751fb0 65162-734 HUMAN PRESCRIPTI
ON DRUG Felbamate Felbamate TABLET ORAL 20110916
ANDA ANDA201680 Amneal Pharmaceuticals FELBAMATE 400 mg/1
ical Activity [PE]"
65162-735_95dbc5f9-1253-4164-ad97-62249b751fb0 65162-735 HUMAN PRESCRIPTI
ON DRUG Felbamate Felbamate TABLET ORAL 20110916
ANDA ANDA201680 Amneal Pharmaceuticals FELBAMATE 600 mg/1
ical Activity [PE]"
ticals PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 "Phenothiazine [EPC],Phe
65162-751_bcc86c49-cb25-4907-b8f2-514826a20850 65162-751 HUMAN PRESCRIPTI
ticals BENAZEPRIL HYDROCHLORIDE 5 mg/1 "Angiotensin Converting
Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased
Blood Pressure [PE]"
65162-770_7e0d1d25-746f-4280-aee9-6f33e7ac5034 65162-770 HUMAN OTC DRUG
Ibuprofen Pain Reliever/Fever Reducer Ibuprofen "CAPSULE, LIQUID
FILLED" ORAL 20110915 ANDA ANDA202300 Amneal P
harmaceuticals IBUPROFEN 200 mg/1
53746-052_ec37677d-9ec1-4aec-9cf7-66c0702d6d3e 53746-052 HUMAN PRESCRIPTI
ANDA ANDA077289 "Amneal Pharmaceuticals of New York, LLC" CITALOPR
AM HYDROBROMIDE 10 mg/1 "Serotonin Reuptake Inhibitor [EPC],Serotonin Up
53746-101_920f07f7-ba95-4ef3-9beb-2dc9fc2bddfe 53746-101 HUMAN PRESCRIPTI
ANDA ANDA078428 "Amneal Pharmaceuticals of New York, LLC" GABAPENT
53746-109_b422b6c2-139c-40c2-bfed-724d61edd3c3 53746-109 HUMAN PRESCRIPTI
ANDA040736 "Amneal Pharmaceuticals of New York, LLC" ACETAMINOPHEN; H
YDROCODONE BITARTRATE 325; 5 mg/1; mg/1 "Opioid Agonist [EPC],Opioid Ago
nists [MoA]" CIII
53746-140_2d202e25-8db1-4a89-baf9-194ce169ebe0 53746-140 HUMAN OTC DRUG
Ibuprofen Pain Releiver/ Fever Reducer Ibuprofen TABLET ORAL
20091216 ANDA ANDA071333 "Amneal Pharmaceuticals of New Y
ork, LLC" IBUPROFEN 200 mg/1
53746-143_2d202e25-8db1-4a89-baf9-194ce169ebe0 53746-143 HUMAN OTC DRUG
Ibuprofen Pain Releiver/ Fever Reducer Ibuprofen TABLET ORAL
ork, LLC" IBUPROFEN 200 mg/1
53746-218_5ca2ce11-f2d9-490c-b569-e571e41a2e90 53746-218 HUMAN PRESCRIPTI
ON DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL
ork, LLC" METFORMIN HYDROCHLORIDE 500 mg/1 "Biguanide [EPC],Biguani
53746-464_5c61d290-13c0-480e-b8b5-94416bce4c30 53746-464 HUMAN PRESCRIPTI
ANDA ANDA078558 "Amneal Pharmaceuticals of New York, LLC" IBUPROFE
N 400 mg/1 "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-infla
]"
]"
]"
53746-542_ea24099d-b8e8-4f00-80f0-655f9527f78f 53746-542 HUMAN PRESCRIPTI
ED RELEASE" ORAL 20130222 ANDA ANDA202128 "Amneal
Pharmaceuticals of New York, LLC" POTASSIUM CHLORIDE 750 mg/1
53746-617_e8a55822-02b8-440b-97db-6e2a6e99d6bc 53746-617 HUMAN PRESCRIPTI
ANDA090485 "Amneal Pharmaceuticals of New York, LLC" ACETAMINOPHEN; T
RAMADOL HYDROCHLORIDE 325; 37.5 mg/1; mg/1 "Full Opioid Agonists [M
oA],Opioid Agonist [EPC]"
65162-047_b1513f9e-7008-4c45-bbb3-64b266d4f6c8 65162-047 HUMAN PRESCRIPTI
ON DRUG Oxycodone Hydrochloride Oxycodone TABLET ORAL 20121030
ANDA ANDA203638 "Amneal Pharmaceuticals of New York, LLC" OXYCODON
" CII
" CII
" CII
" CII
" CII
65162-052_0346785b-f610-4834-a721-fec9106ee4e9 65162-052 HUMAN PRESCRIPTI
65162-101_509a5464-82b5-466b-a036-8f18a588a7e2 65162-101 HUMAN PRESCRIPTI
65162-193_ded1f570-ab4b-499f-942e-60c87f04bd81 65162-193 HUMAN PRESCRIPTI
ANDA ANDA078432 "Amneal Pharmaceuticals of New York, LLC" NAPROXEN
SODIUM 275 mg/1 "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-infla
]"
65162-194_ded1f570-ab4b-499f-942e-60c87f04bd81 65162-194 HUMAN PRESCRIPTI
ANDA ANDA078432 "Amneal Pharmaceuticals of New York, LLC" NAPROXEN
SODIUM 550 mg/1 "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-infla
]"
65162-207_2e0e3dad-c2b4-4383-b049-f95e00160196 65162-207 HUMAN PRESCRIPTI
TABLET ORAL 20131101 ANDA ANDA040778 "Amneal Pharmace
uticals of New York, LLC" ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 7.5
65162-209_95b772aa-9fb1-4ab2-abef-2bb9ed6b2687 65162-209 HUMAN PRESCRIPTI
ON DRUG Nevirapine Nevirapine TABLET ORAL 20140430
ANDA ANDA078195 "Amneal Pharmaceuticals of New York, LLC" NEVIRAPI
NE 200 mg/1 "Human Immunodeficiency Virus 1 Non-Nucleoside Analog Re
verse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],
Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducer
s [MoA],Cytochrome P450 2B6 Inducers [MoA]"
65162-212_6e98aac0-71bc-44bc-9ada-8f1b2dbbb090 65162-212 HUMAN PRESCRIPTI
ON DRUG Extended Phenytoin Sodium Phenytoin Sodium CAPSULE
ORAL 20091216 ANDA ANDA040765 "Amneal Pharmaceuticals
of New York, LLC" PHENYTOIN SODIUM 100 mg/1 "Anti-epileptic
E]"
65162-218_717c860a-788b-40f3-b057-beb628baabd1 65162-218 HUMAN PRESCRIPTI
65162-300_cccb9e14-d921-4d56-a9a0-5db5b752fc75 65162-300 HUMAN PRESCRIPTI
ON DRUG Venlafaxine Hydrochloride Venlafaxine TABLET ORAL
ork, LLC" VENLAFAXINE HYDROCHLORIDE 25 mg/1 "Norepinephrine
ork, LLC" VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 "Norepinephrine
65162-316_33e5b594-340c-440a-a914-1bc255a401f1 65162-316 HUMAN PRESCRIPTI
ON DRUG Lomedia 24 Fe Norethindrone Acetate and Ethinyl Estradiol
KIT 20131220 ANDA ANDA078267 "Amneal Pharmace
uticals of New York, LLC"
65162-347_83f380c0-a952-4540-bd78-18a44778768f 65162-347 HUMAN PRESCRIPTI
ON DRUG Zenchent FE Norethindrone and Ethinyl Estradiol KIT
ork, LLC"
65162-414_f138d1db-c5ca-4292-b27b-8e4b0c98dab6 65162-414 HUMAN PRESCRIPTI
ON DRUG Clopidogrel Clopidogrel TABLET ORAL 20130930
ANDA ANDA203751 "Amneal Pharmaceuticals of New York, LLC" CLOPIDOG
REL BISULFATE 75 mg/1 "Decreased Platelet Aggregation [PE],P2Y12 Plate
let Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA]"
65162-468_2f6464fd-3fd9-4963-94c8-e438cce94f15 65162-468 HUMAN PRESCRIPTI
ON DRUG Clindamycin Palmitate Hydrochloride Clindamycin Palmitate Hy
drochloride "POWDER, FOR SOLUTION" ORAL 20130902 ANDA
ANDA203513 "Amneal Pharmaceuticals of New York, LLC" CLINDAMYCIN PALM
ITATE HYDROCHLORIDE 75 mg/5mL "Decreased Sebaceous Gland Activity [PE]
,Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient]"
65162-528_e40537c0-b43b-4d65-9639-d938acadfcbb 65162-528 HUMAN PRESCRIPTI
ork, LLC" LEVETIRACETAM 250 mg/1 "Anti-epileptic Agent [EPC],Decr
65162-617_996bfdad-4017-4d05-b758-6bed426e966e 65162-617 HUMAN PRESCRIPTI
ANDA090485 "Amneal Pharmaceuticals of New York, LLC" ACETAMINOPHEN; T
RAMADOL HYDROCHLORIDE 325; 37.5 mg/1; mg/1 "Full Opioid Agonists [M
65162-627_2899c52b-09f2-46ba-b7df-c45ecb41d64d 65162-627 HUMAN PRESCRIPTI
ORAL 20101115 ANDA ANDA076003 "Amneal Pharmaceuticals
of New York, LLC" TRAMADOL HYDROCHLORIDE 50 mg/1 "Full Opioid Ago
nists [MoA],Opioid Agonist [EPC]" CIV
65162-641_0156fd39-7bb0-40ba-9464-d5bb46b48b7c 65162-641 HUMAN PRESCRIPTI
ork, LLC" FLECAINIDE ACETATE 50 mg/1 Antiarrhythmic [EPC]
65162-685_d3a4be08-4bd7-4bd8-92cb-13b26f7a8099 65162-685 HUMAN PRESCRIPTI
ANDA ANDA090992 "Amneal Pharmaceuticals of New York, LLC" LEVETIRA
CETAM 100 mg/mL "Anti-epileptic Agent [EPC],Decreased Central Nervous Sy
65162-689_f9265ca2-e473-450b-8c36-b4be187df548 65162-689 HUMAN PRESCRIPTI
ON DRUG Nitrofurantoin Nitrofurantoin SUSPENSION ORAL 20110324
ANDA ANDA201679 "Amneal Pharmaceuticals of New York, LLC" NITROFUR
ANTOIN 25 mg/5mL "Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/In
gredient]"
65162-691_81c6eeaf-e543-4f5e-b6fa-701a95b9f4a0 65162-691 HUMAN PRESCRIPTI
ON DRUG Ondansetron Ondansetron SOLUTION ORAL 20101217
ANDA ANDA091483 "Amneal Pharmaceuticals of New York, LLC" ONDANSET
RON HYDROCHLORIDE 4 mg/5mL "Serotonin 3 Receptor Antagonists [MoA],
65162-705_c493b0a1-8224-419a-b142-5899787a53c5 65162-705 HUMAN PRESCRIPTI
ON DRUG Escitalopram Oxalate Escitalopram SOLUTION ORAL
ork, LLC" ESCITALOPRAM OXALATE 5 mg/5mL "Serotonin Reuptake Inhi
65162-835_b59c9412-2795-44da-aa61-b662f93b211c 65162-835 HUMAN PRESCRIPTI
ON DRUG Acyclovir Acyclovir OINTMENT TOPICAL 20140103
ANDA ANDA204605 "Amneal Pharmaceuticals of New York, LLC" ACYCLOVI
R 50 mg/g "DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nu
cleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside An
alog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase
Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient]"
65162-955_407923ab-956c-4a6d-b130-bd78c93f1de6 65162-955 HUMAN PRESCRIPTI
ON DRUG Esomeprazole strontium Esomeprazole strontium "CAPSULE, DELAYE
D RELEASE" ORAL 20130812 NDA AUTHORIZED GENERIC NDA20234
2 "Amneal Pharmaceuticals of New York, LLC" ESOMEPRAZOLE STRONTIUM
20 mg/1 "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytoch
rome P450 2C19 Inhibitors [MoA]"
65162-957_407923ab-956c-4a6d-b130-bd78c93f1de6 65162-957 HUMAN PRESCRIPTI
D RELEASE" ORAL 20130812 NDA AUTHORIZED GENERIC NDA20234
2 "Amneal Pharmaceuticals of New York, LLC" ESOMEPRAZOLE STRONTIUM
65162-998_accf9dc9-6f40-4e8b-8cc4-272525e53160 65162-998 HUMAN PRESCRIPTI
ON DRUG Fosphenytoin Sodium Fosphenytoin Sodium INJECTION
"Amneal Pharmaceuticals of New York, LLC" FOSPHENYTOIN SODIUM 50
65162-999_accf9dc9-6f40-4e8b-8cc4-272525e53160 65162-999 HUMAN PRESCRIPTI
ON DRUG Fosphenytoin Sodium Fosphenytoin Sodium INJECTION
"Amneal Pharmaceuticals of New York, LLC" FOSPHENYTOIN SODIUM 50
65162-536_66cb91e7-0780-4800-8590-794455196a1b 65162-536 HUMAN PRESCRIPTI
ON DRUG Benzonatate Benzonatate "CAPSULE, LIQUID FILLED"
ORAL 20100604 ANDA ANDA040682 Amneal Pharmaceuticals o
f NY LLC BENZONATATE 100 mg/1 "Decreased Tracheobronchial Stre
tch Receptor Activity [PE],Non-narcotic Antitussive [EPC]"
65162-537_66cb91e7-0780-4800-8590-794455196a1b 65162-537 HUMAN PRESCRIPTI
ON DRUG Benzonatate Benzonatate "CAPSULE, LIQUID FILLED"
ORAL 20100604 ANDA ANDA040682 Amneal Pharmaceuticals o
f NY LLC BENZONATATE 200 mg/1 "Decreased Tracheobronchial Stre
tch Receptor Activity [PE],Non-narcotic Antitussive [EPC]"
53746-077_80781c80-37a9-4b91-8cd9-8346d5d0c7c8 53746-077 HUMAN PRESCRIPTI
ON DRUG Esterified Estrogens and Methyltestosterone Esterified Estro
gens and Methyltestosterone TABLET ORAL 20100922 UNAPPROV
ED DRUG OTHER "Amneal Pharmaceuticals, LLC" "ESTROGENS, CONJUGATED;
METHYLTESTOSTERONE" .625; 1.25 mg/1; mg/1 "Estrogen [EPC],Estrogen
Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient],Andro
gen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient]"
CIII
53746-078_80781c80-37a9-4b91-8cd9-8346d5d0c7c8 53746-078 HUMAN PRESCRIPTI
ED DRUG OTHER "Amneal Pharmaceuticals, LLC" "ESTROGENS, CONJUGATED;
METHYLTESTOSTERONE" 1.25; 2.5 mg/1; mg/1 "Estrogen [EPC],Estrogen
Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient],Andro
gen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient]"
CIII
53746-110_1980a079-60a2-4c2d-9e6f-cdef1281b626 53746-110 HUMAN PRESCRIPTI
ANDA040746 "Amneal Pharmaceuticals, LLC" ACETAMINOPHEN; HYDROCODONE BITAR
CIII
53746-116_feedf13d-a605-4f43-a750-f2055d7c09d3 53746-116 HUMAN PRESCRIPTI
"Amneal Pharmaceuticals, LLC" HYDROCODONE BITARTRATE; IBUPROFEN 2.5; 200
"Amneal Pharmaceuticals, LLC" HYDROCODONE BITARTRATE; IBUPROFEN 10; 200
53746-118_55f5960d-0e6d-40d7-91af-4c91233d57e2 53746-118 HUMAN PRESCRIPTI
ANDA040769 "Amneal Pharmaceuticals, LLC" ACETAMINOPHEN; HYDROCODONE BITAR
oA]" CIII
"Amneal Pharmaceuticals, LLC" HYDROCODONE BITARTRATE; IBUPROFEN 7.5; 200
"Amneal Pharmaceuticals, LLC" HYDROCODONE BITARTRATE; IBUPROFEN 5; 200
53746-203_939dd7c0-6181-41a3-8d48-43a2886ed823 53746-203 HUMAN PRESCRIPTI
uticals, LLC" ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 5 mg/1; mg/1
53746-204_9f24a2c3-5fba-4573-a4bf-0b99c8e4f54f 53746-204 HUMAN PRESCRIPTI
53746-205_d896462e-a75e-43f2-b6aa-f73c2369ff5c 53746-205 HUMAN PRESCRIPTI
uticals, LLC" ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 500; 7.5 mg/1; mg
/1 "Full Opioid Agonists [MoA],Opioid Agonist [EPC]" CII
53746-206_d896462e-a75e-43f2-b6aa-f73c2369ff5c 53746-206 HUMAN PRESCRIPTI
53746-271_06268883-a7a3-4ccc-ad9e-71d8ca2a43db 53746-271 HUMAN PRESCRIPTI
"Amneal Pharmaceuticals, LLC" SULFAMETHOXAZOLE; TRIMETHOPRIM 400; 80 mg/1; mg
53746-272_06268883-a7a3-4ccc-ad9e-71d8ca2a43db 53746-272 HUMAN PRESCRIPTI
"Amneal Pharmaceuticals, LLC" SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160
53746-511_25ea75ed-3117-4657-a0ef-d7645e138dd5 53746-511 HUMAN PRESCRIPTI
ON DRUG Spironolactone Spironolactone TABLET ORAL 20100802
ANDA ANDA091426 "Amneal Pharmaceuticals, LLC" SPIRONOLACTONE 25
mg/1 "Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]"
53746-955_96bf1146-b1e0-4f8d-a8c0-976471c2e292 53746-955 HUMAN PRESCRIPTI
D RELEASE" ORAL 20130812 NDA NDA202342 "Amneal
Pharmaceuticals, LLC" ESOMEPRAZOLE STRONTIUM 20 mg/1 "Proton Pump Inh
ibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]"
53746-957_96bf1146-b1e0-4f8d-a8c0-976471c2e292 53746-957 HUMAN PRESCRIPTI
D RELEASE" ORAL 20130812 NDA NDA202342 "Amneal
Pharmaceuticals, LLC" ESOMEPRAZOLE STRONTIUM 40 mg/1 "Proton Pump Inh
ibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]"
65162-033_fb61ed37-a227-480c-aee9-66e1cd5eb469 65162-033 HUMAN PRESCRIPTI
ON DRUG Acetaminophen and Codeine Acetaminophen and Codeine
uticals, LLC" ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1
"Full Opioid Agonists [MoA],Opioid Agonist [EPC]"
65162-351_d0777805-a448-4008-817f-38daa7f0c9a4 65162-351 HUMAN PRESCRIPTI
ON DRUG Sildenafil Sildenafil TABLET ORAL 20121108
ANDA ANDA202025 "Amneal Pharmaceuticals, LLC" SILDENAFIL CITRATE
20 mg/1 "Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibit
ors [MoA]"
65162-361_fbbe0b01-3c35-4451-bc4e-08128d010156 65162-361 HUMAN PRESCRIPTI
ANDA ANDA040625 "Amneal Pharmaceuticals, LLC" FOLIC ACID 1
mg/1
65162-415_d6722371-c21a-4dfc-a3e6-5b852b77d43b 65162-415 HUMAN PRESCRIPTI
ON DRUG Buprenorphine HCl and Naloxone HCl Buprenorphine and Naloxo
ne TABLET SUBLINGUAL 20130222 ANDA ANDA203136
"Amneal Pharmaceuticals, LLC" BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLOR
IDE DIHYDRATE 8; 2 mg/1; mg/1 "Partial Opioid Agonist [EPC],Partial Op
ioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA]" CIII
65162-416_d6722371-c21a-4dfc-a3e6-5b852b77d43b 65162-416 HUMAN PRESCRIPTI
"Amneal Pharmaceuticals, LLC" BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLOR
IDE DIHYDRATE 2; .5 mg/1; mg/1 "Partial Opioid Agonist [EPC],Partial Op
65162-441_919bcc5b-7175-4360-abee-1a137ec96e53 65162-441 HUMAN PRESCRIPTI
ON DRUG Meclizine Hydrochloride Meclizine TABLET ORAL 20100212
ANDA ANDA201451 "Amneal Pharmaceuticals, LLC" MECLIZINE HYDROCHLORIDE
12.5 mg/1 "Antiemetic [EPC],Emesis Suppression [PE]"
20100212 ANDA ANDA201451 "Amneal Pharmaceuticals, LLC"
]"
]"
65162-511_40c2501b-98f8-497a-8d32-22e2cc587fb0 65162-511 HUMAN PRESCRIPTI
65162-553_eccdf309-eb53-4f71-8ab0-a3cc97fb2f87 65162-553 HUMAN PRESCRIPTI
ANDA ANDA203399 "Amneal Pharmaceuticals, LLC" METAXALONE 800
65162-668_3a2826b9-7c80-4f0c-b154-bc02ec55b658 65162-668 HUMAN PRESCRIPTI
ON DRUG PRENATAL PLUS "VITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC AC
ID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBO
FLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCI
UM CARBONATE, FERROUS FUMARATE, ZINC OXIDE, CUPRIC OXIDE" "TABLET, FILM CO
ATED" ORAL 20091202 UNAPPROVED DRUG OTHER "Amneal
Pharmaceuticals, LLC" ".ALPHA.-TOCOPHEROL ACETATE, DL-; .BETA.-CAROTENE; ASCOR
BIC ACID; CALCIUM CARBONATE; CHOLECALCIFEROL; CUPRIC OXIDE; CYANOCOBALAMIN; FERR
OUS FUMARATE; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THI
AMINE MONONITRATE; VITAMIN A ACETATE; ZINC OXIDE" 22; 920; 120; 200; 400;
2; 12; 27; 1; 20; 10; 3; 1.84; 3080; 25 mg/1; [iU]/1; mg/1; mg/1; [iU]/1; mg/1;
ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1 "Vitamin A [Chemical/Ing
redient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin
B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Inc
reased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, D
ivalent [Chemical/Ingredient]"
65162-669_f1931f84-682c-43bf-a02b-b458a85d497d 65162-669 HUMAN PRESCRIPTI
ON DRUG Acebutolol Hydrochloride Acebutolol Hydrochloride
CAPSULE ORAL 20091201 ANDA ANDA075047 "Amneal Pharmace
uticals, LLC" ACEBUTOLOL HYDROCHLORIDE 200 mg/1 "Adrenergic beta
65162-670_f1931f84-682c-43bf-a02b-b458a85d497d 65162-670 HUMAN PRESCRIPTI
CAPSULE ORAL 20091201 ANDA ANDA075047 "Amneal Pharmace
uticals, LLC" ACEBUTOLOL HYDROCHLORIDE 400 mg/1 "Adrenergic beta
65162-678_b6ca5bbe-2e88-4fe2-b732-1d38a1da97aa 65162-678 HUMAN PRESCRIPTI
ON DRUG Promethazine Hydrochloride Promethazine SOLUTION
ORAL 20091230 ANDA ANDA040882 "Amneal Pharmaceuticals,
LLC" PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL "Phenothiazine [EPC],Phe
65162-687_5c796954-3952-4203-902e-e7fc6638c8ea 65162-687 HUMAN PRESCRIPTI
ON DRUG Lorazepam Lorazepam CONCENTRATE ORAL 20100201
ANDA ANDA091383 "Amneal Pharmaceuticals, LLC" LORAZEPAM 2
mg/mL "Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]" CIV
65162-693_5d952312-6afe-4fb0-aee5-bee7ea5f9eea 65162-693 HUMAN PRESCRIPTI
ON DRUG Atovaquone Atovaquone SUSPENSION ORAL 20111209
ANDA ANDA202960 "Amneal Pharmaceuticals, LLC" ATOVAQUONE 750
mg/5mL "Antimalarial [EPC],Antiprotozoal [EPC]"
65162-698_78d017f0-90bd-4bea-81a6-2ac73822fee9 65162-698 HUMAN PRESCRIPTI
ON DRUG Gabapentin Gabapentin SOLUTION ORAL 20110930
ANDA ANDA202024 "Amneal Pharmaceuticals, LLC" GABAPENTIN 250
65162-702_7e067c03-321b-4867-83b6-12413b93e112 65162-702 HUMAN PRESCRIPTI
ON DRUG Fluocinolone Acetonide Fluocinolone Acetonide OIL AURICULA
R (OTIC) 20111017 ANDA ANDA091306 "Amneal Pharmace
uticals, LLC" FLUOCINOLONE ACETONIDE 0.11 mg/20mL "Corticosteroid [EPC],Co
65162-703_86f09bb4-6e2c-4c20-9b76-ee36cd627975 65162-703 HUMAN PRESCRIPTI
ON DRUG Fluocinolone Acetonide Fluocinolone Acetonide OIL TOPICAL
FLUOCINOLONE ACETONIDE 0.11 mg/118.28mL "Corticosteroid [EPC],Corticoste
65162-704_67e604ed-038c-4237-b711-66a7dc70f47b 65162-704 HUMAN PRESCRIPTI
FLUOCINOLONE ACETONIDE 0.11 mg/118.28mL "Corticosteroid [EPC],Corticoste
65162-761_eb1f77e0-a70f-470b-9199-1b9b8d6cc4fa 65162-761 HUMAN PRESCRIPTI
ANDA ANDA202202 "Amneal Pharmaceuticals, LLC" WARFARIN SODIUM 1
ANDA ANDA202202 "Amneal Pharmaceuticals, LLC" WARFARIN SODIUM 2.5
ANDA ANDA202202 "Amneal Pharmaceuticals, LLC" WARFARIN SODIUM 7.5
65162-809_d454635a-c186-46cb-b673-fd10b2d08165 65162-809 HUMAN PRESCRIPTI
LLC" ALPRAZOLAM 0.5 mg/1 "Benzodiazepine [EPC],Benzodiazepines [C
LLC" ALPRAZOLAM 1 mg/1 "Benzodiazepine [EPC],Benzodiazepines [C
53150-209_87bed912-1bb0-4527-a25e-f4447baf564c 53150-209 HUMAN PRESCRIPTI
ANDA ANDA078195 "Amneal-Agila, LLC" NEVIRAPINE 200 mg/1
"Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhi
bitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse T
ranscriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450
2B6 Inducers [MoA]"
53150-247_fa3e9573-f016-49ed-9ec8-1da4c07274f1 53150-247 HUMAN PRESCRIPTI
ON DRUG Epirubicin Hydrochloride Epirubicin Hydrochloride
"Amneal-Agila, LLC" EPIRUBICIN HYDROCHLORIDE 200 mg/100mL
"Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient
],Topoisomerase Inhibitors [MoA]"
53150-250_fa3e9573-f016-49ed-9ec8-1da4c07274f1 53150-250 HUMAN PRESCRIPTI
"Amneal-Agila, LLC" EPIRUBICIN HYDROCHLORIDE 50 mg/25mL "Anthrac
ycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topois
omerase Inhibitors [MoA]"
53150-314_7e9e34a5-0865-4193-aa65-41a7b87821dc 53150-314 HUMAN PRESCRIPTI
ON DRUG DOXOrubicin Hydrochloride DOXOrubicin Hydrochloride
"Amneal-Agila, LLC" DOXORUBICIN HYDROCHLORIDE 20 mg/10mL "Anthrac
"Amneal-Agila, LLC" DOXORUBICIN HYDROCHLORIDE 200 mg/100mL
53150-336_176934bd-fd14-4485-bc73-ae43b4942b5b 53150-336 HUMAN PRESCRIPTI
ON DRUG Idarubicin Hydrochloride Idarubicin Hydrochloride
"Amneal-Agila, LLC" IDARUBICIN HYDROCHLORIDE 5 mg/5mL "Anthrac
53150-415_539951c7-0516-4970-86db-84fe6b95d813 53150-415 HUMAN PRESCRIPTI
ON DRUG Haloperidol Decanoate Haloperidol Decanoate INJECTION
INTRAMUSCULAR 20130423 ANDA ANDA075440 "Amneal-Agila, L
LC" HALOPERIDOL DECANOATE 50 mg/mL Typical Antipsychotic [EPC]
53150-697_d94a88ed-96a4-41ee-84fb-9514c0987b85 53150-697 HUMAN PRESCRIPTI
ON DRUG Calcium Chloride Calcium Chloride INJECTION
INTRAVENOUS 20130531 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE
"Amneal-Agila, LLC" CALCIUM CHLORIDE 100 mg/mL "Blood Coagulati
on Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ing
redient],Cations, Divalent [Chemical/Ingredient]"
53150-871_d4595229-52b1-4ddb-8fcf-d9422406ca43 53150-871 HUMAN PRESCRIPTI
E" INTRAVENOUS 20120423 ANDA ANDA202650 "Amneal-
Agila, LLC" ZOLEDRONIC ACID 4 mg/5mL "Bisphosphonate [EPC],Diphosphon
ates [Chemical/Ingredient]"
29943-002_8482e2bb-657c-4361-85c1-3a7341aa6091 29943-002 HUMAN OTC DRUG
blink tears polyethylene glycol 400 SOLUTION/ DROPS OPHTHALMIC
20080201 OTC MONOGRAPH FINAL part349 "AMO Hangzhou Co., LTD"
POLYETHYLENE GLYCOL 400 2.5 mg/mL
29943-004_117f10af-354b-4371-8754-b976e0a90c10 29943-004 HUMAN OTC DRUG
blink gel tears polyethylene glycol 400 SOLUTION/ DROPS OPHTHALMIC
20080501 OTC MONOGRAPH FINAL part349 "AMO Hangzhou Co., LTD"
POLYETHYLENE GLYCOL 400 2.5 mg/mL
43419-001_e7bb91b4-f4cd-43b0-bb76-429d948a0dd0 43419-001 HUMAN OTC DRUG
Sulwhasoo Lumitouch Base "OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE"
LOTION TOPICAL 20110501 OTC MONOGRAPH NOT FINAL part352 AMOREPAC
IFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .9; .498; .588 g/30mL;
g/30mL; g/30mL
43419-002_ebf2ff60-8042-49fb-a850-fdd2b5a541e2 43419-002 HUMAN OTC DRUG
Sulwhasoo Lumitouch Foundation No. 21 "OCTINOXATE, TITANIUM DIOXIDE, a
nd ZINC OXIDE" LOTION TOPICAL 20110501 OTC MONOGRAPH NOT FINAL
part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .9; .498
; .588 g/30mL; g/30mL; g/30mL
; .588 g/30mL; g/30mL; g/30mL
43419-004_832e72a8-86b7-4c44-ba55-9883d79fdafa 43419-004 HUMAN OTC DRUG
Sulwhasoo Age-veil UV protection "OCTINOXATE, OCTISALATE, OCTOCRYLENE, TI
TANIUM DIOXIDE, and ZINC OXIDE" CREAM TOPICAL 20110501 OTC MONO
GRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; OCTISALATE; OCTOCRYLENE; TIT
ANIUM DIOXIDE; ZINC OXIDE 2.8; 1.8; 3.2; 1.768; .0412 g/40mL; g/40mL;
g/40mL; g/40mL; g/40mL
43419-005_8cce279e-f151-4b91-9635-b0002554b109 43419-005 HUMAN OTC DRUG
SULWHASOO SNOWISE BRIGHTENING BB BASE NO.1 "OCTINOXATE, TITANIUM DIOXIDE, a
part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; .99
6; 2.352 g/30mL; g/30mL; g/30mL
43419-006_8cce279e-f151-4b91-9635-b0002554b109 43419-006 HUMAN OTC DRUG
SULWHASOO SNOWISE BRIGHTENING BB BASE NO.2 "OCTINOXATE, TITANIUM DIOXIDE, a
6; 2.352 g/30mL; g/30mL; g/30mL
; .588 g/30mL; g/30mL; g/30mL
43419-008_2de54174-ec98-41b2-b74e-a21fe8cc8999 43419-008 HUMAN OTC DRUG
Sulwhasoo Lumitouch Compact No.21 Natural Beige "OCTINOXATE, TITANIUM DI
OXIDE, and ZINC OXIDE" POWDER TOPICAL 20111223 OTC MONOGRAPH NO
T FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE
.56; 3.3572; 1.3706 g/14g; g/14g; g/14g
43419-009_2de54174-ec98-41b2-b74e-a21fe8cc8999 43419-009 HUMAN OTC DRUG
Sulwhasoo Lumitouch Compact No.23 True Beige "OCTINOXATE, TITANIUM DI
.56; 3.3572; 1.3706 g/14g; g/14g; g/14g
43419-010_a0f06994-ffcb-49fd-b61c-634696e7aa54 43419-010 HUMAN OTC DRUG
Sulwhasoo Lumitouch Foundation "OCTINOXATE, TITANIUM DIOXIDE, and ZINC
OXIDE" LIQUID TOPICAL 20111223 OTC MONOGRAPH NOT FINAL part352
AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .9; .246; .291
43419-013_73376ae2-606e-46b1-9749-2427abc3de5e 43419-013 HUMAN OTC DRUG
Sulwhasoo Snowise Foundation "OCTINOXATE, TITANIUM DIOXIDE, and ZINC
OXIDE" POWDER TOPICAL 20111223 OTC MONOGRAPH NOT FINAL part352
64 g/9g; g/9g; g/9g
43419-014_73376ae2-606e-46b1-9749-2427abc3de5e 43419-014 HUMAN OTC DRUG
Sulwhasoo Snowise Foundation "OCTINOXATE, TITANIUM DIOXIDE, and ZINC
64 g/9g; g/9g; g/9g
43419-015_91ed8fd4-5c5e-4157-a22c-7d5c51c1a1df 43419-015 HUMAN OTC DRUG
Sulwhasoo Lumitouch Foundation SPF 25 No.21 Natural Beige "OCTINOXATE, TIT
ANIUM DIOXIDE, and ZINC OXIDE" POWDER TOPICAL 20111223 OTC MONO
GRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE
.352; .4697; .2156 g/11g; g/11g; g/11g
Sulwhasoo Lumitouch Foundation SPF 25 No 23. True Beige "OCTINOXATE, TIT
.352; .4697; .2156 g/11g; g/11g; g/11g
Sulwhasoo Lumitouch Foundation SPF 25 No 25. Dark Beige "OCTINOXATE, TIT
.352; .4697; .2156 g/11g; g/11g; g/11g
43419-018_a879375f-07d3-4d04-941a-b31b3122e5dc 43419-018 HUMAN OTC DRUG
Sulwhasoo Lumitouch Base SPF 15 No.40 Light Violet "OCTINOXATE, TIT
ANIUM DIOXIDE, and ZINC OXIDE" LIQUID TOPICAL 20120103 OTC MONO
.9; .249; .294 g/30mL; g/30mL; g/30mL
43419-019_5b8fb785-8257-464b-ba3e-791e1210d5bd 43419-019 HUMAN OTC DRUG
Sulwhasoo Lumitouch Base SPF 15 No. 60 Light Green "OCTINOXATE, TIT
ANIUM DIOXIDE, and ZINC OXIDE" LIQUID TOPICAL 20120103 OTC MONO
.9; .249; .294 g/30mL; g/30mL; g/30mL
43419-020_9b0f74e0-05e8-4d0c-b6e4-fb9e2f15d676 43419-020 HUMAN OTC DRUG
Sulwhasoo Lumitouch Base "OCTINOXATE, TITANIUM DIOXIDE, and ZINC
OXIDE" CREAM TOPICAL 20120103 OTC MONOGRAPH NOT FINAL part352
43419-021_d7c986c3-d47e-4994-97b5-e0e0c9529ba6 43419-021 HUMAN OTC DRUG
Sulwhasoo Lumitouch Foundation No.21 Natural Beige "OCTINOXATE, TITANIUM DI
OXIDE, and ZINC OXIDE" CREAM TOPICAL 20110103 OTC MONOGRAPH NO
.9; .498; .588 mL/30mL; mL/30mL; mL/30mL
43419-022_d7c986c3-d47e-4994-97b5-e0e0c9529ba6 43419-022 HUMAN OTC DRUG
Sulwhasoo Lumitouch Foundation No.21 Natural Beige "OCTINOXATE, TITANIUM DI
OXIDE, and ZINC OXIDE" CREAM TOPICAL 20110103 OTC MONOGRAPH NO
.9; .498; .588 mL/30mL; mL/30mL; mL/30mL
43419-023_31ded521-3a39-4e26-baf8-cd3d448956d2 43419-023 HUMAN OTC DRUG
Sulwhasoo EVENFAIR SMOOTHING FOUNDATION SPF25 NO. 2 medium beige OCTINOXA
TE LIQUID TOPICAL 20121123 OTC MONOGRAPH NOT FINAL part352
AMOREPACIFIC OCTINOXATE 1.95 g/30mL
43419-024_31ded521-3a39-4e26-baf8-cd3d448956d2 43419-024 HUMAN OTC DRUG
Sulwhasoo EVENFAIR SMOOTHING FOUNDATION SPF25 NO. 3 MEDIUM OCHER OCTINOXA
TE LIQUID TOPICAL 20121123 OTC MONOGRAPH NOT FINAL part352
AMOREPACIFIC OCTINOXATE 1.95 g/30mL
43419-025_113926fa-00ab-4023-94e2-5181590dcf9c 43419-025 HUMAN OTC DRUG
Sulwhasoo EVENFAIR SMOOTHING FOUNDATION SPF25 NO.2 MEDIUM BEIGE "OCTINOXATE, TIT
.32; .4268; .196 g/10g; g/10g; g/10g
43419-026_113926fa-00ab-4023-94e2-5181590dcf9c 43419-026 HUMAN OTC DRUG
Sulwhasoo EVENFAIR SMOOTHING FOUNDATION SPF25 NO.3 MEDIUM OCHER "OCTINOXATE, TIT
.32; .4268; .196 g/10g; g/10g; g/10g
43419-027_7aafcd71-ba80-4ed2-8b3f-47dd7955ce4b 43419-027 HUMAN OTC DRUG
Sulwhasoo evenfair smoothing makeup base NO. 1 OCTINOXATE LOTION
TOPICAL 20130215 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC
OCTINOXATE 1.95 g/30mL
43419-028_7aafcd71-ba80-4ed2-8b3f-47dd7955ce4b 43419-028 HUMAN OTC DRUG
Sulwhasoo EVENFAIR SMOOTHING MAKEUP BASE NO. 2 OCTINOXATE LOTION
43419-029_67734c96-a867-4277-af5a-4bc3a9440a93 43419-029 HUMAN OTC DRUG
Sulwhasoo SNOWISE BRIGHTENING SERUM BB "OCTINOXATE, TITANIUM DIOXIDE, a
nd ZINC OXIDE" CREAM TOPICAL 20130508 OTC MONOGRAPH NOT FINAL
part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.4276;
1.151376; 2.718912 g/30mL; g/30mL; g/30mL
43419-030_67734c96-a867-4277-af5a-4bc3a9440a93 43419-030 HUMAN OTC DRUG
SulwhasooSNOWISE BRIGHTENING SERUM BB "OCTINOXATE, TITANIUM DIOXIDE, a
part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.4276;
1.151376; 2.718912 g/30mL; g/30mL; g/30mL
43419-031_2e0c3863-69ed-4ea6-8a02-924888263cc0 43419-031 HUMAN OTC DRUG
SULWHASOO EVENFAIR PERFECTING CUSHION NO.21 "OCTINOXATE, TITANIUM DI
OXIDE, and ZINC OXIDE" LOTION TOPICAL 20140205 OTC MONOGRAPH NO
1.05; .6225; 1.47 g/15g; g/15g; g/15g
1.05; .6225; 1.47 g/15g; g/15g; g/15g
1.05; .6225; 1.47 g/15g; g/15g; g/15g
43419-034_3f9d14b8-25cf-442b-baff-466d1ba03b9f 43419-034 HUMAN OTC DRUG
SULWHASOO EVENFAIR COMPACT NO.21 OCTINOXATE and TITANIUM DIOXIDE
CREAM TOPICAL 20140205 OTC MONOGRAPH NOT FINAL part352 AMOREPAC
IFIC OCTINOXATE; TITANIUM DIOXIDE .22; 2.2 g/11g; g/11g
43419-301_f4201a49-ddb2-4ff8-a113-a26156c4c029 43419-301 HUMAN OTC DRUG
IOPE RETIGEN ESSENCE DUAL CONCEALER OCTINOXATE and TITANIUM DIOXIDE
KIT 20110801 OTC MONOGRAPH NOT FINAL part352 AMOREPAC
IFIC
43419-302_9e65df95-5e66-463a-ac85-0dcd1fab6b05 43419-302 HUMAN OTC DRUG
IOPE RETIGEN GLOW COVER CAKE NO.21 "OCTINOXATE, TITANIUM DIOXIDE, and ZINC
g/14g; g/14g; g/14g
43419-303_9e65df95-5e66-463a-ac85-0dcd1fab6b05 43419-303 HUMAN OTC DRUG
IOPE RETIGEN GLOW COVER CAKE NO.23 "OCTINOXATE, TITANIUM DIOXIDE, and ZINC
g/14g; g/14g; g/14g
43419-304_5c265840-4e76-4bd7-9d3b-bdbc7f428255 43419-304 HUMAN OTC DRUG
IOPE RETIGEN MOISTURE BASE NATURAL YELLOW "OCTINOXATE, TITANIUM DI
2.45; .581; .686 g/35mL; g/35mL; g/35mL
43419-305_5c265840-4e76-4bd7-9d3b-bdbc7f428255 43419-305 HUMAN OTC DRUG
IOPE RETIGEN MOISTURE BASE NATURAL GREEN "OCTINOXATE, TITANIUM DI
2.45; .581; .686 g/35mL; g/35mL; g/35mL
43419-306_6e77ad66-0751-436d-bf30-bafa7749d22c 43419-306 HUMAN OTC DRUG
IOPE RETIGEN LUMINOUS BASE "OCTINOXATE, TITANIUM DIOXIDE, and ZINC
OXIDE" LOTION TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352
AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.45; .581; .686
43419-307_b00ed4ca-3f94-40c6-8d5c-1566afa6e5f1 43419-307 HUMAN OTC DRUG
IOPE RETIGEN MOISTURE FOUNDATION NO.17 SPF22 PA PLUS "OCTINOXATE, TIT
ANIUM DIOXIDE, and ZINC OXIDE" LOTION TOPICAL 20110801 OTC MONO
1.75; .8715; .343 g/35mL; g/35mL; g/35mL
1.75; .8715; .343 g/35mL; g/35mL; g/35mL
1.75; .8715; .343 g/35mL; g/35mL; g/35mL
43419-310_09c83fd7-f2d9-4fa6-83f4-89c8384c3df0 43419-310 HUMAN OTC DRUG
AMOREPACIFIC NATURAL PROTECTOR "OCTINOXATE, TITANIUM DIOXIDE, and ZINC
mg/mL; mg/mL; mg/mL
43419-311_f3c9d5d7-2707-499a-a337-86d6a55b381c 43419-311 HUMAN OTC DRUG
IOPE RETIGEN MOISTURE TWIN CAKE NO.21 "OCTINOXATE, TITANIUM DIOXIDE, a
8; .4116 g/14g; g/14g; g/14g
8; .4116 g/14g; g/14g; g/14g
8; .4116 g/14g; g/14g; g/14g
43419-314_0323917f-ea6f-435b-af30-a19958aea323 43419-314 HUMAN OTC DRUG
IOPE RETIGEN SMOOTHING PACT NO.1 SPF25 PA PLUS PLUS "OCTINOXATE, TITANIUM DI
.84; .86912; .4116 g/14g; g/14g; g/14g
43419-315_0323917f-ea6f-435b-af30-a19958aea323 43419-315 HUMAN OTC DRUG
IOPE RETIGEN SMOOTHING PACT NO.2 SPF25 PA PLUS PLUS "OCTINOXATE, TITANIUM DI
.84; .86912; .4116 g/14g; g/14g; g/14g
43419-320_1dd3c170-59af-4dc4-95c7-ecffbea0e784 43419-320 HUMAN OTC DRUG
AMOREPACIFIC TIME RESPONSE SKIN RENEWAL NO. 100 "OCTINOXATE, TITANIUM DI
.05; .0098; .1014 mg/mL; mg/mL; mg/mL
.05; .0098; .1014 mg/mL; mg/mL; mg/mL
.05; .0098; .1014 mg/mL; mg/mL; mg/mL
.05; .0098; .1014 mg/mL; mg/mL; mg/mL
.05; .0098; .1014 mg/mL; mg/mL; mg/mL
.05; .0098; .1014 mg/mL; mg/mL; mg/mL
.05; .0098; .1014 mg/mL; mg/mL; mg/mL
.05; .0098; .1014 mg/mL; mg/mL; mg/mL
43419-330_f3df54e7-44b5-403a-ac57-a7d2030fc009 43419-330 HUMAN OTC DRUG
IOPE BRIGHTGEN "OXYBENZONE, OCTINOXATE, OCTISALATE, HOMOSALATE, OCTOCRY
LENE, and TITANIUM DIOXIDE" CREAM TOPICAL 20120824 OTC MONO
GRAPH NOT FINAL part352 AMOREPACIFIC HOMOSALATE; OCTINOXATE; OCTISALATE; OCTO
CRYLENE; OXYBENZONE; TITANIUM DIOXIDE 3; 4.2; 2.7; 3; 2.7; 3.12 g/60mL;
g/60mL; g/60mL; g/60mL; g/60mL; g/60mL
43419-339_0028cf3c-35f0-42c6-abca-1a6988527598 43419-339 HUMAN OTC DRUG
IOPE B.B. SPF20/PA plus Octinoxate and TITANIUM DIOXIDE CREAM TOPICAL
20100801 OTC MONOGRAPH FINAL part352 AMOREPACIFIC OCTINOXA
TE; TITANIUM DIOXIDE 2; 1.2 mL/40mL; mL/40mL
43419-340_edbcf755-9d78-4a14-a1c7-98ed41b5f9b4 43419-340 HUMAN OTC DRUG
IOPE B.B BB OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20120919
OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE
2; .996 g/40mL; g/40mL
43419-353_d0b27b5a-417c-4c7b-be2a-428948a5e4dd 43419-353 HUMAN OTC DRUG
IOPE Air Cushion Sunblock EX "OCTINOXATE, TITANIUM DIOXIDE, and ZINC
OXIDE" CREAM TOPICAL 20100801 OTC MONOGRAPH FINAL part352
AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; 1.25; 2.94
g/30g; g/30g; g/30g
43419-354_537432ef-b52d-4770-955d-5c10a3b0099d 43419-354 HUMAN OTC DRUG
IOPE S.S. CONDITIONING COLOR BASE No.40 SPF22 PA PLUS "Octinoxate, TITANIUM DI
.05; .0439; .0098 mL/mL; mL/mL; mL/mL
43419-355_537432ef-b52d-4770-955d-5c10a3b0099d 43419-355 HUMAN OTC DRUG
IOPE S.S. CONDITIONING COLOR BASE No.60 SPF22 PA PLUS "Octinoxate, TITANIUM DI
.05; .0439; .0098 mL/mL; mL/mL; mL/mL
43419-356_896bd2e2-e57c-4ed0-9d82-396a7e4e3cd1 43419-356 HUMAN OTC DRUG
IOPE SS CONDITIONING FOUNDATION NO.13 SPF22 PA PLUS "Octinoxate, TITANIUM DI
.05; .03; .01 mL/mL; mL/mL; mL/mL
.05; .03; .01 mL/mL; mL/mL; mL/mL
.05; .03; .01 mL/mL; mL/mL; mL/mL
.05; .03; .01 mL/mL; mL/mL; mL/mL
43419-360_0318c320-9a6c-4422-9b09-9d8308342631 43419-360 HUMAN OTC DRUG
IOPE SS CONDITIONING TWINCAKE NO.13 SPF25 PA PLUS PLUS OCTINOXATE and ZINC OXID
E POWDER TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352
AMOREPACIFIC OCTINOXATE; ZINC OXIDE .06; .03 g/g; g/g
43419-367_9158dfc4-b723-4815-a56f-a6be47fb8909 43419-367 HUMAN OTC DRUG
IOPE SUPER VITAL EXTRA MOIST B.B "OCTINOXATE, TITANIUM DIOXIDE, a
715; .686 mL/35mL; mL/35mL; mL/35mL
43419-370_04641e32-dc2b-4345-8e1d-21bf4b36fd44 43419-370 HUMAN OTC DRUG
IOPE SUPER VITAL EXTRA MOIST BASE "TITANIUM DIOXIDE, OCTINOXATE, a
715; .343 g/35mL; g/35mL; g/35mL
43419-371_9dc3748c-3c49-4ebe-9ad7-b29dabdeeb3f 43419-371 HUMAN OTC DRUG
IOPE SUPER VITAL EXTRA MOIST FOUNDATION NO. 21 SPF12 PA PLUS TITANIUM
DIOXIDE and OCTINOXATE LOTION TOPICAL 20110201 OTC MONOGRAPH NO
T FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE 1.75; .287
g/35mL; g/35mL
43419-372_9dc3748c-3c49-4ebe-9ad7-b29dabdeeb3f 43419-372 HUMAN OTC DRUG
IOPE SUPER VITAL EXTRA MOIST FOUNDATION NO. 23 SPF12 PA PLUS TITANIUM
DIOXIDE and OCTINOXATE LOTION TOPICAL 20110201 OTC MONOGRAPH NO
T FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE 1.75; .287
g/35mL; g/35mL
43419-373_45279514-2e53-43be-b9c0-96dea36c8140 43419-373 HUMAN OTC DRUG
IOPE SUPER VITAL EXTRA MOIST TWIN PACT NO. 21 SPF25 PA PLUS PLUS "TITANIU
M DIOXIDE, OCTINOXATE, AND ZINC OXIDE" POWDER TOPICAL 20110201
OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZI
NC OXIDE 1.08; 1.11744; .5292 g/18g; g/18g; g/18g
43419-374_45279514-2e53-43be-b9c0-96dea36c8140 43419-374 HUMAN OTC DRUG
IOPE SUPER VITAL EXTRA MOIST TWIN PACT NO. 23 SPF25 PA PLUS PLUS "TITANIU
M DIOXIDE, OCTINOXATE, AND ZINC OXIDE" POWDER TOPICAL 20110201
OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZI
NC OXIDE 1.08; 1.11744; .5292 g/18g; g/18g; g/18g
43419-380_4abd5f7b-2c87-4d1e-a1f2-83a02cee5574 43419-380 HUMAN OTC DRUG
IOPE AIR CUSHION XP "OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE"
IFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.05; .6225; 1.47
g/15g; g/15g; g/15g
43419-381_4abd5f7b-2c87-4d1e-a1f2-83a02cee5574 43419-381 HUMAN OTC DRUG
IOPE AIR CUSHION XP "OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE"
g/15g; g/15g; g/15g
43419-382_9adc493e-5e87-4502-b10a-4491d37f4a6a 43419-382 HUMAN OTC DRUG
IOPE AIR CUSHION XP COVER VANILLA BROAD SPECTRUM SPF50PLUS "OCTINOXATE, TIT
1.05; .6225; 1.47 g/15g; g/15g; g/15g
43419-383_9adc493e-5e87-4502-b10a-4491d37f4a6a 43419-383 HUMAN OTC DRUG
IOPE AIR CUSHION XP COVER BEIGE BROAD SPECTRUM SPF50PLUS "OCTINOXATE, TIT
1.05; .6225; 1.47 g/15g; g/15g; g/15g
43419-384_d286e618-8b72-4491-9966-6473022ea291 43419-384 HUMAN OTC DRUG
IOPE AIR CUSHION XP NATURAL 31 "OCTINOXATE, TITANIUM DIOXIDE, and ZINC
AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.05; .6225; 1.4
7 g/15g; g/15g; g/15g
43419-398_ffedcffa-aac5-463c-b490-16343b139dc8 43419-398 HUMAN OTC DRUG
IOPE MILD CLINIC SUN PROTECTOR TITANIUM DIOXIDE and ZINC OXIDE CREAM
TITANIUM DIOXIDE; ZINC OXIDE 2.22; 4.53 mL/60mL; mL/60mL
43419-501_248a1fcf-3edc-41ae-8cef-1872cd2c427b 43419-501 HUMAN OTC DRUG
AMOREPACIFIC MOISTURE BOUND NO. 102 OCTINOXATE and TITANIUM DIOXIDE LOTION
OCTINOXATE; TITANIUM DIOXIDE 2.5; 1.05 mL/50mL; mL/50mL
43419-505_a4a3b32c-42fa-472f-80a7-03e0c15b3503 43419-505 HUMAN OTC DRUG
AMOREPACIFIC TIME RESPONSE NO. 102 "OCTINOXATE, TITANIUM DIOXIDE, and ZINC
AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.5; 1.245; .294
43419-511_609d1a43-dfc9-4816-aca0-596f3c623e6c 43419-511 HUMAN OTC DRUG
AMOREPACIFIC COLOR CONTROL CUSHION COMPACT NO.104 "OCTINOXATE, TITANIUM DI
1.05; .6225; 1.47 g/15g; g/15g; g/15g
1.05; .6225; 1.47 g/15g; g/15g; g/15g
1.05; .6225; 1.47 g/15g; g/15g; g/15g
1.05; .6225; 1.47 g/15g; g/15g; g/15g
43419-515_bbc224e7-d0e5-417b-ae97-844cbbb591cb 43419-515 HUMAN OTC DRUG
AMOREPACIFIC FUTURE RESPONSE Age Defense SPF30 "OCTINOXATE, OCTISALATE,
OCTOCRYLENE, and TITANIUM DIOXIDE" CREAM TOPICAL 20130125
OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; OCTISALATE; OCTOCRYL
ENE; TITANIUM DIOXIDE 3.6505; 2.34675; 4.172; 2.2946 g/50mL; g/50mL; g/50mL;
g/50mL
43419-516_6ab34ca6-e83f-4247-bbed-ed10fe2a8694 43419-516 HUMAN OTC DRUG
AMOREPACIFIC FUTURE RESPONSE AGE DEFENSE DUAL EYE WITH SPF 25 SUNSCREEN
"OCTINOXATE, OCTISALATE, OCTOCRYLENE, and TITANIUM DIOXIDE" KIT
20140108 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC
43419-545_8c8a8d80-82c2-4f7b-9274-d07c8d71f73f 43419-545 HUMAN OTC DRUG
Mamonde Total Mineral Moisture BB SPF20 PA plus OCTINOXATE and TITANIUM
DIOXIDE CREAM TOPICAL 20100601 OTC MONOGRAPH FINAL part352
AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE 2.5; 1.5 mL/50mL; mL/50mL
43419-546_2d9d3750-5164-4eb8-b8a7-fa8b4735fb5d 43419-546 HUMAN OTC DRUG
MAMONDE BRIGHTENING PACT 10HR N21 "OCTINOXATE, TITANIUM DIOXIDE, a
nd ZINC OXIDE" POWDER TOPICAL 20101001 OTC MONOGRAPH NOT FINAL
55; .02 g/g; g/g; g/g
43419-547_2d9d3750-5164-4eb8-b8a7-fa8b4735fb5d 43419-547 HUMAN OTC DRUG
MAMONDE BRIGHTENING PACT 10HR N23 "OCTINOXATE, TITANIUM DIOXIDE, a
55; .02 g/g; g/g; g/g
43419-701_7aa57ff1-7e9b-422a-b5ce-df8102506a03 43419-701 HUMAN OTC DRUG
LANEIGE LIP TREATMENT SPF 17 No.1 OCTINOXATE STICK TOPICAL 20110901
OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE 0.12 g/4g
43419-704_2c4475f5-0e16-4bed-a5f6-c8b165363d94 43419-704 HUMAN OTC DRUG
LANEIGE BB Cushion Light "OCTINOXATE, TITANIUM DIOXIDE, and ZINC
7 g/15g; g/15g; g/15g
LANEIGE BB Cushion Medium "OCTINOXATE, TITANIUM DIOXIDE, and ZINC
7 g/15g; g/15g; g/15g
LANEIGE BB Cushion Dark "OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE"
g/15g; g/15g; g/15g
43419-707_8e35813b-f397-47e6-b92f-f72b9bbf7777 43419-707 HUMAN OTC DRUG
LANEIGE BB Cushion no.21 "OCTINOXATE, TITANIUM DIOXIDE, and ZINC
7 g/15g; g/15g; g/15g
43419-708_8e35813b-f397-47e6-b92f-f72b9bbf7777 43419-708 HUMAN OTC DRUG
LANEIGE BB Cushion no.23 "OCTINOXATE, TITANIUM DIOXIDE, and ZINC
7 g/15g; g/15g; g/15g
43419-709_6d635814-5a57-48b0-9398-f9592b8bcabf 43419-709 HUMAN OTC DRUG
LANEIGE Skin Veil Foundation EX No. 21N Natural Beige OCTINOXATE
IFIC OCTINOXATE 1.95 g/30mL
LANEIGE Skin Veil Foundation EX No. 23 Sand Beige OCTINOXATE
LANEIGE Skin Veil Foundation EX No. 31 Brown Beige OCTINOXATE
43419-712_102d2cba-3484-4133-b6eb-bff324002d93 43419-712 HUMAN OTC DRUG
LANEIGE SKIN VEIL BASE EX No.40 Light Purple OCTINOXATE LOTION
43419-713_102d2cba-3484-4133-b6eb-bff324002d93 43419-713 HUMAN OTC DRUG
LANEIGE SKIN VEIL BASE EX No.60 Light Green OCTINOXATE LOTION
43419-714_4536c1c6-d397-4a3b-8907-7d1b8da640d5 43419-714 HUMAN OTC DRUG
Sulwhasoo Lumitouch Multi-Base No.1 "Octinoxate, TITANIUM DIOXIDE, and ZINC
43419-715_4536c1c6-d397-4a3b-8907-7d1b8da640d5 43419-715 HUMAN OTC DRUG
Sulwhasoo Lumitouch Multi-Base No.2 "Octinoxate, TITANIUM DIOXIDE, and ZINC
43419-730_c3bfec20-de78-4f51-b414-3e7f8a67b520 43419-730 HUMAN OTC DRUG
LANEIGE Snow BB No.1 Brightening BB "OCTINOXATE, TITANIUM DIOXIDE, a
part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.8; 2.3
24; .784 g/40mL; g/40mL; g/40mL
43419-731_c3bfec20-de78-4f51-b414-3e7f8a67b520 43419-731 HUMAN OTC DRUG
LANEIGE Snow BB No.2 Natural BB "OCTINOXATE, TITANIUM DIOXIDE, and ZINC
43419-744_a5fd9a8b-efdd-47a0-bc24-4c64abf84357 43419-744 HUMAN OTC DRUG
LANEIGE MYSTIC VEIL FOUNDATION No. 21 "Octinoxate, TITANIUM DIOXIDE, and ZINC
AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.25; 1.70426; .
49 mL/25mL; mL/25mL; mL/25mL
43419-745_a5fd9a8b-efdd-47a0-bc24-4c64abf84357 43419-745 HUMAN OTC DRUG
LANEIGE MYSTIC VEIL FOUNDATION No. 23 "Octinoxate, TITANIUM DIOXIDE, and ZINC
AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.25; 1.70426; .
49 mL/25mL; mL/25mL; mL/25mL
43419-746_392dd6e2-7407-4946-994d-a419737f9e14 43419-746 HUMAN OTC DRUG
Laneige Sliding Pact EX snow crystal No.1 "OCTINOXATE, TITANIUM DIOXIDE, a
496; .3528 g/12g; g/12g; g/12g
Laneige sliding pact EX snow crystal No.2 "OCTINOXATE, TITANIUM DIOXIDE, a
496; .3528 g/12g; g/12g; g/12g
496; .3528 g/12g; g/12g; g/12g
496; .3528 g/12g; g/12g; g/12g
496; .3528 g/12g; g/12g; g/12g
43419-801_239f6a22-a845-4aad-a1a1-f34e1ba390cc 43419-801 HUMAN OTC DRUG
Mamonde Total Moisture BB 01 "OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE"
IFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2; .996; .784 g/40mL;
g/40mL; g/40mL
43419-802_239f6a22-a845-4aad-a1a1-f34e1ba390cc 43419-802 HUMAN OTC DRUG
Mamonde Total Moisture BB 02 "OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE"
IFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2; .996; .784 g/40mL;
g/40mL; g/40mL
43419-803_d696898b-3844-4c8b-8bac-07181178bb4a 43419-803 HUMAN OTC DRUG
MAMONDE PACT BLOOMING 21 "OCTINOXATE, TITANIUM DIOXIDE, and ZINC
352 g/12g; g/12g; g/12g
43419-804_d696898b-3844-4c8b-8bac-07181178bb4a 43419-804 HUMAN OTC DRUG
MAMONDE PACT BLOOMING 23 "OCTINOXATE, TITANIUM DIOXIDE, and ZINC
352 g/12g; g/12g; g/12g
43419-811_725711cf-9695-425c-b6f1-e892bea63e00 43419-811 HUMAN OTC DRUG
LANEIGE SunScreen Triple "OCTINOXATE, TITANIUM DIOXIDE, and ZINC
AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 70; 58.1; 19.6
mg/mL; mg/mL; g/mL
43419-850_2b702ef4-ae8f-4043-902d-70d6a91717f2 43419-850 HUMAN OTC DRUG
LANEIGE SKIN VEIL BASE NO. 20 SPF 26 PA PLUS "OCTINOXATE, TITANIUM DI
.05; .037; .012 mg/mL; mg/mL; mg/mL
43419-851_2b702ef4-ae8f-4043-902d-70d6a91717f2 43419-851 HUMAN OTC DRUG
LANEIGE SKIN VEIL BASE NO. 40 SPF 26 PA PLUS "OCTINOXATE, TITANIUM DI
.05; .037; .012 mg/mL; mg/mL; mg/mL
43419-852_7cb0ea13-db9b-4986-94dd-b086e2e5ee89 43419-852 HUMAN OTC DRUG
LANEIGE SKIN VEIL BASE SPF 26 PA plus "Octinoxate, TITANIUM DIOXIDE, a
nd ZINC OXIDE" LOTION TOPICAL 20100901 OTC MONOGRAPH FINAL
part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.5; 1.1
1; .36 mL/30mL; mL/30mL; mL/30mL
43419-853_9d982d2c-428c-49ef-a195-3816bfe252dc 43419-853 HUMAN OTC DRUG
Laneige Skin Veil NO.21 SPF 26 PAplus "OCTINOXATE, TITANIUM DIOXIDE, a
55; .012 mg/mL; mg/mL; mg/mL
43419-857_05ba4362-a6e2-4aca-858d-b691cfcb143a 43419-857 HUMAN OTC DRUG
LANEIGE SNOW CRYSTAL No. 21 SPF22 PAplus "Octinoxate, TITANIUM DIOXIDE, a
43419-861_1b0a97ed-7a21-4bfb-97ae-dd640b276e9a 43419-861 HUMAN OTC DRUG
Laneige UV TOTAL BASE "Octinoxate, TITANIUM DIOXIDE, and ZINC OXIDE"
IFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .07; .084; .02 mg/mL; m
g/mL; mg/mL
43419-862_1b0a97ed-7a21-4bfb-97ae-dd640b276e9a 43419-862 HUMAN OTC DRUG
Laneige UV TOTAL BASE "Octinoxate, TITANIUM DIOXIDE, and ZINC OXIDE"
IFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .07; .084; .02 mg/mL; m
g/mL; mg/mL
43419-863_2a43db72-7e0f-4bf2-b9e4-81ef73a2f989 43419-863 HUMAN OTC DRUG
LANEIGE SATIN FINISH TWIN PACT NO. 13 "TITANIUM DIOXIDE, OCTINOXATE, a
; .0294 mg/g; mg/g; mg/g
; .0294 mg/g; mg/g; mg/g
; .0294 mg/g; mg/g; mg/g
; .0294 mg/g; mg/g; mg/g
; .0294 mg/g; mg/g; mg/g
43419-901_bf4c0f3c-2f14-49fb-88a6-5be78b2dea50 43419-901 HUMAN OTC DRUG
SONGYUM New Pinesalt SODIUM FLUORIDE PASTE DENTAL 20130305
OTC MONOGRAPH NOT FINAL part355 AMOREPACIFIC SODIUM FLUORIDE 0.198 g/90g
43419-902_313de4c6-5e5d-4376-ba5e-b8f49d2ad619 43419-902 HUMAN OTC DRUG
MEDIAN New Marine fluoride SODIUM FLUORIDE PASTE DENTAL 20130305
43419-903_ccebb021-c38f-415c-b000-af8083e9802f 43419-903 HUMAN OTC DRUG
MEDIAN New Forest SODIUM FLUORIDE PASTE DENTAL 20130305
43419-716_f4464483-1b9f-4b9a-ab2f-3001b26cf5b7 43419-716 HUMAN OTC DRUG
Sulwhasoo Lumitouch "Foundation SPF15, PA plus" "OCTINOXATE, TITANIUM DI
OXIDE, and ZINC OXIDE" LOTION TOPICAL 20100901 OTC MONOGRAPH FI
NAL part352 AMOREPACIFIC CO. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE
.9; 2.584; .2939 mL/30mL; mL/30mL; mL/30mL
43419-717_b0cc649f-c625-4272-913c-705d779a99f5 43419-717 HUMAN OTC DRUG
Sulwhasoo Lumitouch "Base Makeup SPF15, PA plus" "OCTINOXATE, TITANIUM DI
OXIDE, and ZINC OXIDE" LOTION TOPICAL 20100901 OTC MONOGRAPH FI
.9; .82; .294 mL/30mL; mL/30mL; mL/30mL
43419-718_0dff6226-0138-4049-b413-883588a5a13d 43419-718 HUMAN OTC DRUG
Sulwhasoo Lumitouch "Foundation SPF26, PA plus plus" "OCTINOXATE, TIT
GRAPH FINAL part352 AMOREPACIFIC CO. OCTINOXATE; TITANIUM DIOXIDE; ZI
NC OXIDE .56; 3.358; 1.371 g/14g; g/14g; g/14g
43419-719_ccfe56ff-4382-4b3e-8fdb-3c9650473823 43419-719 HUMAN OTC DRUG
Sulwhasoo Lumitouch "Twincake SPF25, PA plus plus" "OCTINOXATE, TITANIUM DI
OXIDE, and ZINC OXIDE" CREAM TOPICAL 20100901 OTC MONOGRAPH FI
.352; 1.533; .216 g/11g; g/11g; g/11g
0548-1140_a20da7f1-87db-469c-90de-9b9fdabbdb40 0548-1140 HUMAN PRESCRIPTI
ON DRUG Phytonadione Phytonadione "INJECTION, EMULSION" PARENTER
AL 19880324 ANDA ANDA083722 "Amphastar Pharmaceutica
ls, Inc." PHYTONADIONE 1 mg/.5mL "Increased Prothrombin Activity
[PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vita
min K [EPC],Warfarin Reversal Agent [EPC]"
0548-1240_4c6e84de-e87a-407a-8e25-c158b3c5ce99 0548-1240 HUMAN PRESCRIPTI
ON DRUG Phytonadione Phytonadione "INJECTION, EMULSION" PARENTER
AL 20030418 ANDA ANDA083722 "Amphastar Pharmaceutica
ls, Inc." PHYTONADIONE 1 mg/.5mL "Increased Prothrombin Activity
[PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vita
min K [EPC],Warfarin Reversal Agent [EPC]"
0548-1469_19750aa4-d28a-437a-9b99-8ccd82137d8d 0548-1469 HUMAN PRESCRIPTI
ON DRUG Naloxone Hydrochloride Naloxone Hydrochloride INJECTION
PARENTERAL 19880401 ANDA ANDA072076 "Amphastar Pharm
aceuticals, Inc." NALOXONE HYDROCHLORIDE 1 mg/mL "Opioid Antagoni
st [EPC],Opioid Antagonists [MoA]"
0548-1911_a8afdf64-6ed1-43ac-91e8-22d2bad3768b 0548-1911 HUMAN PRESCRIPTI
ON DRUG Morphine Sulfate Morphine Sulfate "INJECTION, SOLU
TION" INTRAVENOUS; SUBCUTANEOUS 19870327 UNAPPROVED DRUG
OTHER "Amphastar Pharmaceuticals, Inc." MORPHINE SULFATE
30 mg/30mL "Full Opioid Agonists [MoA],Opioid Agonist [EPC]" CII
0548-3011_d9168a3e-abe4-4120-bde3-f968af317157 0548-3011 HUMAN PRESCRIPTI
ON DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride JELLY TOPICAL
19790807 ANDA ANDA086283 "Amphastar Pharmaceuticals, Inc.
" LIDOCAINE HYDROCHLORIDE 20 mg/mL "Amide Local Anesthetic [EPC],Am
ides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE]"
0548-3301_7a8088b4-be7f-457e-8421-9af36844bd13 0548-3301 HUMAN PRESCRIPTI
ON DRUG Dextrose Monohydrate Dextrose Monohydrate INJECTION
PARENTERAL 20000601 UNAPPROVED DRUG OTHER "Amphast
ar Pharmaceuticals, Inc." DEXTROSE MONOHYDRATE 500 mg/mL
0548-3304_37203471-df31-4230-a3c1-4825a8d909d4 0548-3304 HUMAN PRESCRIPTI
ON DRUG Calcium Chloride Calcium Chloride INJECTION
ar Pharmaceuticals, Inc." CALCIUM CHLORIDE 100 mg/mL "Blood C
oagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chem
ical/Ingredient],Cations, Divalent [Chemical/Ingredient]"
0548-3316_7b3e43ae-0b95-407c-a269-650b57dec42d 0548-3316 HUMAN PRESCRIPTI
ON DRUG Epinephrine Epinephrine INJECTION PARENTERAL
20100825 UNAPPROVED DRUG OTHER "Amphastar Pharmaceutica
ls, Inc." EPINEPHRINE 0.1 mg/mL "Adrenergic alpha-Agonists [MoA]
,Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic A
gonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient]"
0548-3339_baf8e070-0519-4e50-ac2d-61f5752cc534 0548-3339 HUMAN PRESCRIPTI
ON DRUG Atropine Sulfate Atropine Sulfate INJECTION
ar Pharmaceuticals, Inc." ATROPINE SULFATE 0.1 mg/mL "Anticho
linergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [
EPC],Cholinergic Muscarinic Antagonists [MoA]"
0548-3352_4dc1f73b-d2c0-4b0e-99d2-919e7bdef116 0548-3352 HUMAN PRESCRIPTI
ON DRUG Sodium Bicarbonate Sodium Bicarbonate INJECTION
ar Pharmaceuticals, Inc." SODIUM BICARBONATE 84 mg/mL
0548-3369_19750aa4-d28a-437a-9b99-8ccd82137d8d 0548-3369 HUMAN PRESCRIPTI
ON DRUG Naloxone Hydrochloride Naloxone Hydrochloride INJECTION
aceuticals, Inc." NALOXONE HYDROCHLORIDE 1 mg/mL "Opioid Antagoni
st [EPC],Opioid Antagonists [MoA]"
0548-3390_f9b77f7a-e3bc-412b-bc46-f29c9126a0e5 0548-3390 HUMAN PRESCRIPTI
ON DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride INJECTION
aceuticals, Inc." LIDOCAINE HYDROCHLORIDE 20 mg/mL "Amide Local Ane
[PE]"
0548-3391_a8afdf64-6ed1-43ac-91e8-22d2bad3768b 0548-3391 HUMAN PRESCRIPTI
ON DRUG Morphine Sulfate morphine sulfate "INJECTION, SOLU
TION" INTRAVENOUS; SUBCUTANEOUS 20000811 UNAPPROVED DRUG
OTHER "Amphastar Pharmaceuticals, Inc." MORPHINE SULFATE
10 mg/10mL "Full Opioid Agonists [MoA],Opioid Agonist [EPC]" CII
0548-5601_5366f3fa-5bf8-43bd-9490-103cf23eaf20 0548-5601 HUMAN PRESCRIPTI
ON DRUG Enoxaparin Sodium Enoxaparin sodium INJECTION
SUBCUTANEOUS 20110919 ANDA ANDA076684 "Amphastar Pharm
aceuticals, Inc." ENOXAPARIN SODIUM 100 mg/mL "Heparin, Low-Mo
lecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC]"
0548-5631_2979830b-c1e5-4061-9eb9-50bfa135c49a 0548-5631 HUMAN PRESCRIPTI
0548-5900_b48eb5b6-b611-456a-8a78-b1f78256e477 0548-5900 HUMAN PRESCRIPTI
ON DRUG Cortrosyn Cosyntropin "INJECTION, POWDER, LYOPHILIZED,
FOR SOLUTION" INTRAMUSCULAR; INTRAVENOUS 20030801 NDA
NDA016750 "Amphastar Pharmaceuticals, Inc." COSYNTROPIN 0.25
mg/mL "Adrenocorticotropic Hormone [Chemical/Ingredient],Adrenocorticotropic H
ormone [EPC]"
0548-6300_aaadace4-ffb5-44ad-8fe1-3550917577f1 0548-6300 HUMAN PRESCRIPTI
ON DRUG Laryng-O-Jet Lidocaine Hydrochloride SOLUTION TOPICAL
0548-9061_e3ddcb69-a23e-4b26-af06-44caddcbc442 0548-9061 HUMAN PRESCRIPTI
ON DRUG Epinephrine Epinephrine INJECTION PARENTERAL
20000701 UNAPPROVED DRUG OTHER "Amphastar Pharmaceutica
ls, Inc." EPINEPHRINE 1 mg/mL "Adrenergic alpha-Agonists [MoA]
,Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic A
gonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient]"
0548-9090_e8549939-d712-4d4c-8e18-4b9d3c6ea7d2 0548-9090 HUMAN PRESCRIPTI
ON DRUG AMPHADASE hyaluronidase INJECTION SUBCUTANEOUS
20041026 NDA NDA021665 "Amphastar Pharmaceuticals, Inc.
" HYALURONIDASE 150 [USP'U]/mL "Endoglycosidase [EPC],Glycoside
Hydrolases [Chemical/Ingredient]"
67752-0001_928c5bfc-70bc-4ff6-a6db-7b404538ec79 67752-0001 HUMAN OTC DRUG
AMSure Alcohol Prep ISOPROPYL ALCOHOL SWAB TOPICAL 20120301
OTC MONOGRAPH NOT FINAL part333A "Amsino International, Inc." ISOPROPY
L ALCOHOL 0.7 mL/mL
67752-2003_9bd269b7-ebe5-4c99-8dd6-3023cdd3f3f0 67752-2003 HUMAN OTC DRUG
AMSure Three Povidone-Iodine Swabsticks Povidone-Iodine SWAB TOPICAL
20120106 OTC MONOGRAPH FINAL part333C "Amsino Internat
ional, Inc." POVIDONE-IODINE 0.1 mg/mL
50390-000_3024fdf8-4958-4df2-83e2-0b86b5fb22dd 50390-000 HUMAN OTC DRUG
"SATINIQUE ANTI-DANDRUFF for dry, irritated scalp" PYRITHIONE ZINC
SHAMPOO TOPICAL 20140213 OTC MONOGRAPH FINAL part358H
Amway Corp PYRITHIONE ZINC 9.5 mg/mL
50390-108_8c203a2e-f319-488a-8dff-8a983706fbad 50390-108 HUMAN OTC DRUG
ARTISTRY IDEAL RADIANCE UV Protect SPF 50 PLUS Broad Spectrum Sunscreen
"OCTINOXATE, OCTISALATE, ZINC OXIDE, TITANIUM DIOXIDE" CREAM TOPICAL 20130911
OTC MONOGRAPH NOT FINAL part352 Amway Corp OCTINOXATE; OCTISALATE; TITANIUM
DIOXIDE; ZINC OXIDE 68; 45; 24.9; 126.6 mg/mL; mg/mL; mg/mL; mg/mL
50390-109_c2e64838-f005-4343-b38f-06adbbf2b158 50390-109 HUMAN OTC DRUG
ARTISTRY Time Defiance UV Defense SPF 50 Ultra Facial Sunscreen "OCTINOX
ATE, ZINC OXIDE, OCTISALATE,TITANIUM DIOXIDE" CREAM TOPICAL 20130726
DIOXIDE; ZINC OXIDE 70; 45; 24.9; 125 mg/mL; mg/mL; mg/mL; mg/mL
50390-110_eee8d16c-45bd-40a1-b3ec-f3a5dc3e2131 50390-110 HUMAN OTC DRUG
ARTISTRY Time Defiance UV Defense SPF 50 Ultra Facial Sunscreen "OCTINOX
ATE, ZINC OXIDE, OCTISALATE,TITANIUM DIOXIDE" CREAM TOPICAL 20120510
DIOXIDE; ZINC OXIDE 7.5; 5; 2.49; 6.528 mL/100mL; mL/100mL; mL/100mL; mL
/100mL
50390-111_02fdf286-01ab-40df-8c9c-d054d0fe74c8 50390-111 HUMAN OTC DRUG
ARTISTRY YOUTH XTEND Lifting Smoothing Foundation Broad Spectrum SPF 20 Sunscree
n "OCTINOXATE, OXYBENZONE" CREAM TOPICAL 20130506
OTC MONOGRAPH NOT FINAL part352 Amway Corp OCTINOXATE; OXYBENZONE 75; 10
mg/mL; mg/mL
50390-112_0fd4f3d5-9466-4f0c-8249-5acd0be48896 50390-112 HUMAN OTC DRUG
ARTISTRY YOUTH XTEND Protecting Broad Spectrum SPF 15 Sunscreen "OCTINOX
ATE,AVOBENZONE,OXYBENZONE" CREAM TOPICAL 20130506 OTC MONO
GRAPH NOT FINAL part352 Amway Corp AVOBENZONE; OCTINOXATE; OXYBENZONE
3; 7.5; 1 g/100g; g/100g; g/100g
50390-113_db45ebfe-a6d2-468c-8352-c69dc36b27dd 50390-113 HUMAN OTC DRUG
ARTISTRY YOUTH XTEND Protecting Broad Spectrum SPF 15 "OCTINOXATE,AVOB
ENZONE,OXYBENZONE" LOTION TOPICAL 20130506 OTC MONOGRAPH NO
T FINAL part352 Amway Corp AVOBENZONE; OCTINOXATE; OXYBENZONE 30; 75;
10 mg/mL; mg/mL; mg/mL
50390-709_6bbadb39-a884-49d2-bf73-903b21ab51d5 50390-709 HUMAN OTC DRUG
PETER ISLAND NATURAL MINERAL SUNCREEN BROAD SPECTRUM SPF 60 Water Resistant
"TITANIUM DIOXIDE, ZINC OXIDE" LOTION TOPICAL 20130514 OTC MONO
GRAPH NOT FINAL part352 Amway Corp TITANIUM DIOXIDE; ZINC OXIDE 28; 40
mg/mL; mg/mL
50390-701_12838bda-3b39-4415-a956-cff0532dda35 50390-701 HUMAN OTC DRUG
Peter Island Continuous Sport Sunscreen SPF 50 "HOMOSALATE, OXYBENZONE, OCTISAL
ATE, AVOBENZONE, OCTOCRYLENE" SPRAY TOPICAL 20121126 OTC MONO
GRAPH NOT FINAL part352 AMWAY CORP. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTO
50390-702_d42740ea-1ae3-4a4c-a0b3-a780f5a59c96 50390-702 HUMAN OTC DRUG
part352 AMWAY CORP. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZ
ONE 3; 13; 5; 7; 4 g/100g; g/100g; g/100g; g/100g; g/100g
50390-703_7519d11b-d59f-483a-a242-b38dea2f5b35 50390-703 HUMAN OTC DRUG
Peter Island Kids Sunscreen SPF 65 "HOMOSALATE, OXYBENZONE, OCTISALATE, AVO
T FINAL part352 AMWAY CORP. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE;
OXYBENZONE 3; 15; 5; 10; 6 g/100g; g/100g; g/100g; g/100g; g/100g
50390-704_97e0b336-4a3f-44e1-8fef-69bf4ad865fd 50390-704 HUMAN OTC DRUG
ONE 3; 15; 5; 10; 6 g/100g; g/100g; g/100g; g/100g; g/100g
50390-705_d6626f99-360b-407c-ad4a-c9a9f9258e3c 50390-705 HUMAN OTC DRUG
ONE 2; 10; 5; 2; 2 g/100g; g/100g; g/100g; g/100g; g/100g
50390-706_710ba90e-e8ac-498d-8971-3f6777f9c094 50390-706 HUMAN OTC DRUG
Peter Island Baby Sunscreen SPF 50 "HOMOSALATE, OXYBENZONE, OCTISALATE, AVO
T FINAL part352 AMWAY CORP. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE;
OXYBENZONE 3; 13; 5; 7; 4 g/100g; g/100g; g/100g; g/100g; g/100g
50390-707_1426a253-7c87-489d-95da-1e078f3c9fab 50390-707 HUMAN OTC DRUG
Peter Island Ultimate Sheer Dry Touch Sunscreen SPF 70 "HOMOSALATE, OXYBENZONE,
OCTISALATE, AVOBENZONE, OCTOCRYLENE" LOTION TOPICAL 20121126
OTC MONOGRAPH NOT FINAL part352 AMWAY CORP. AVOBENZONE; HOMOSALATE; OCTISALA
TE; OCTOCRYLENE; OXYBENZONE 3; 15; 5; 2.8; 6 g/100g; g/100g; g/100g;
g/100g; g/100g
50390-708_332591b4-59ee-4ca1-8451-583b5f02c7df 50390-708 HUMAN OTC DRUG
PETER ISLAND Continuous Sunscreen Sport 50 BROAD SPECTRUM SPF 50 Water Resistant
"AVOBENZONE, OCTOCRYLENE, OXYBENZONE" SPRAY TOPICAL 20130514
OTC MONOGRAPH NOT FINAL part352 Amway Corp. AVOBENZONE; OCTOCRYLENE; OXYBENZ
50390-710_08f8985f-774c-4e8d-98e9-95e4d9e3feda 50390-710 HUMAN OTC DRUG
PETER ISLAND Continuous Sunscreen KIDS 50 BROAD SPECTRUM SPF 50 Water Resistant
"AVOBENZONE, OCTOCRYLENE, OXYBENZONE" SPRAY TOPICAL 20130514
OTC MONOGRAPH NOT FINAL part352 Amway Corp. AVOBENZONE; OCTOCRYLENE; OXYBENZ
66780-115_b24d035e-1f0f-4799-b230-1a5fb809e5a1 66780-115 HUMAN PRESCRIPTI
ON DRUG SymlinPen pramlintide acetate INJECTION SUBCUTAN
EOUS 20050316 NDA NDA021332 "Amylin Pharmaceuticals,
LLC" PRAMLINTIDE ACETATE 1000 ug/mL "Amylin Agonists [MoA],Amylin An
alog [EPC]"
66780-121_b24d035e-1f0f-4799-b230-1a5fb809e5a1 66780-121 HUMAN PRESCRIPTI
ON DRUG SymlinPen pramlintide acetate INJECTION SUBCUTAN
EOUS 20050316 NDA NDA021332 "Amylin Pharmaceuticals,
LLC" PRAMLINTIDE ACETATE 1000 ug/mL "Amylin Agonists [MoA],Amylin An
alog [EPC]"
66780-210_dd0e98f1-0f97-4178-9f60-4d13b7192048 66780-210 HUMAN PRESCRIPTI
ON DRUG Byetta exenatide INJECTION SUBCUTANEOUS 20050428
NDA NDA021773 "Amylin Pharmaceuticals, LLC" EXENATIDE 250
ug/mL "GLP-1 Receptor Agonist [EPC],Glucagon-Like Peptide 1 [Chemical/Ingredie
nt],Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]"
66780-212_dd0e98f1-0f97-4178-9f60-4d13b7192048 66780-212 HUMAN PRESCRIPTI
ON DRUG Byetta exenatide INJECTION SUBCUTANEOUS 20050428
NDA NDA021773 "Amylin Pharmaceuticals, LLC" EXENATIDE 250
ug/mL "GLP-1 Receptor Agonist [EPC],Glucagon-Like Peptide 1 [Chemical/Ingredie
nt],Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]"
66780-219_19f6fe9e-e16a-4383-912f-6568c622345a 66780-219 HUMAN PRESCRIPTI
ON DRUG BYDUREON exenatide KIT 20120127
NDA NDA022200 "Amylin Pharmaceuticals, LLC"
66780-226_19f6fe9e-e16a-4383-912f-6568c622345a 66780-226 HUMAN PRESCRIPTI
ON DRUG BYDUREON exenatide KIT 20120127
NDA NDA022200 "Amylin Pharmaceuticals, LLC"
66780-310_189c7038-2646-4dfe-b299-7d77e2e7718c 66780-310 HUMAN PRESCRIPTI
ON DRUG MYALEPT Metreleptin "INJECTION, POWDER, LYOPHILIZED, FOR SOL
UTION" SUBCUTANEOUS 20140522 BLA BLA125390 "Amylin
Pharmaceuticals, LLC" METRELEPTIN 11.3 mg/2.2mL
18087-0001_1a2000c1-f84a-4a17-acc4-bff9ee9498a2 18087-0001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS Anaconda Oxygen Service OXYGEN 99 L/100L
55724-111_ccabd8f6-7612-4fcd-be34-01abd194ea15 55724-111 HUMAN PRESCRIPTI
ON DRUG Kerydin tavaborole SOLUTION TOPICAL 20140707
NDA NDA204427 "Anacor Pharmaceuticals, Inc." TAVABOROLE 43.5
mg/mL
52085-001_5d21586b-622f-4425-aad6-0bdfa251e721 52085-001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS Analgesic Services Inc. dba ASI Medical OXYGEN
99 L/100L
52085-002_76cc375e-fdc8-4909-83d4-5e122c099c92 52085-002 HUMAN PRESCRIPTI
20131201 UNAPPROVED MEDICAL GAS Analgesic Services Inc.
dba ASI Medical NITROGEN 99 L/100L
24453-198_f952377d-d50b-48ec-bb22-5d42a7d522d0 24453-198 HUMAN OTC DRUG
Flawless Tinted Moisturizer Light SPF 18 "Octinoxate, Octisalate, Avobenz
Anastasia Beverly Hills AVOBENZONE; OCTINOXATE; OCTISALATE 3; 7.5; 5
g/100g; g/100g; g/100g
24453-199_978d5900-2ad6-4fe0-983d-2a7c115964f8 24453-199 HUMAN OTC DRUG
Flawless Tinted Moisturizer Medium SPF 18 "Octinoxate, Octisalate, Avobenz
g/100g; g/100g; g/100g
24453-200_786edcbf-d75d-4f4c-b1ad-c82b0dd68594 24453-200 HUMAN OTC DRUG
Flawless Tinted Moisturizer Dark SPF 18 "Octinoxate, Octisalate, Avobenz
g/100g; g/100g; g/100g
35813-373_6e2f940f-8aab-430a-aef6-cf358737b649 35813-373 HUMAN OTC DRUG
DIAPEDIC FOOT TREATMENT MENTHOL LOTION TOPICAL 20110831
OTC MONOGRAPH NOT FINAL part348 "ANASTASIA MARIE LABORATORIES, INC." MENTHOL
1.5 mg/g
35813-374_56f90ad3-67ce-41eb-aeea-4ee81c55c6b4 35813-374 HUMAN OTC DRUG
DIAPEDIC FOOT AND LEG TREATMENT MENTHOL CREAM TOPICAL 20110831
OTC MONOGRAPH NOT FINAL part348 "ANASTASIA MARIE LABORATORIES, INC." MENTHOL
1.5 g/100g
59448-100_f7f8898d-88a4-4efd-806e-2ba5f0d692b1 59448-100 HUMAN OTC DRUG
NewYork-Presbyterian Amenity Sodium Monofluorophospate KIT
20130701 OTC MONOGRAPH FINAL part355 "Anatomy Supply Partners
, LLc"
51808-101_40ecc37d-84df-4f1c-ab4b-30d0c06718a2 51808-101 HUMAN PRESCRIPTI
ON DRUG Sodium Chromate 51 Sodium Chromate 51 SOLUTION
INTRAVENOUS 20120619 UNAPPROVED DRUG OTHER AnazaoHe
alth Corporation CHROMIUM CR-51 1 mCi/5mL
51808-102_130c71b9-1a33-45b2-ab19-e38b6ee0ee68 51808-102 HUMAN PRESCRIPTI
ON DRUG I 123 Mini I 123 Mini CAPSULE ORAL 20120523
UNAPPROVED DRUG OTHER AnazaoHealth Corporation IODIDE ION I-123
10 mCi/1 "Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity
[MoA]"
51808-103_ea9f7125-98b5-49c3-85b8-763915156ff0 51808-103 HUMAN PRESCRIPTI
ON DRUG i 123 MIBG meta iodobenzylguanidine i 123 MIBG "INJECTI
ON, POWDER, LYOPHILIZED, FOR SOLUTION" INTRAVENOUS 20120523
UNAPPROVED DRUG OTHER AnazaoHealth Corporation IOBENGUANE SULFA
TE I-123 25 mCi/1
51808-119_5811e231-e65f-4771-9875-7d8f6197473f 51808-119 HUMAN PRESCRIPTI
ON DRUG I 131 Mini I 131 Mini CAPSULE ORAL 20120523
UNAPPROVED DRUG OTHER AnazaoHealth Corporation SODIUM IODIDE I-
131 500 mCi/1
51808-125_0e714ae6-396c-4488-868e-bfe5fd446f3f 51808-125 HUMAN PRESCRIPTI
ON DRUG In-111 DTPA In-111 DTPA SOLUTION INTRATHECAL
20120619 UNAPPROVED DRUG OTHER AnazaoHealth Corporation
INDIUM IN-111 PENTETATE DISODIUM 3.75 mCi/1.5mL "Lead Chelating
Activity [MoA],Lead Chelator [EPC]"
51808-126_b16e5845-c429-4530-969b-a7cbabe43116 51808-126 HUMAN PRESCRIPTI
ON DRUG Indium 111 Oxyquinolone Indium 111 Oxyquinolone SOLUTION
alth Corporation INDIUM IN-111 OXYQUINOLINE 2 mCi/mL "Radioac
tive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA]"
51808-127_5ed86373-1e27-42fc-a3b3-b198944f0dff 51808-127 HUMAN PRESCRIPTI
ON DRUG P32 Sodium Phosphate P32 Sodium Phosphate "INJECTION, SUSP
ENSION" INTERSTITIAL; INTRA-ARTICULAR; INTRAPERITONEAL; INTRAPLEURAL 20120619
UNAPPROVED DRUG OTHER AnazaoHealth Corporation PHOSPHORUS P-32
5 mCi/mL
51808-128_c099d1ae-d9f6-4176-b55c-233ce52b2976 51808-128 HUMAN PRESCRIPTI
ON DRUG P32 Sodium Phosphate P32 Sodium Phosphate SOLUTION
alth Corporation PHOSPHORUS P-32 10 mCi/4mL
51808-201_651af678-d1d2-4e8e-8fe0-ae6c0ba11a16 51808-201 HUMAN PRESCRIPTI
ON DRUG ACD Solution Modified ACD Solution Modified SOLUTION
alth Corporation ANHYDROUS CITRIC ACID 8 mg/mL "Acidifying Acti
vity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagul
ation Factor Activity [PE],Calcium Chelating Activity [MoA]"
51808-203_8f9023fb-e982-440a-a9ee-374c4bf3153b 51808-203 HUMAN PRESCRIPTI
ON DRUG SIncalide Sincalide "INJECTION, POWDER, LYOPHILIZED,
FOR SOLUTION" INTRAVENOUS 20120619 UNAPPROVED DRUG OTHER
AnazaoHealth Corporation SINCALIDE 3 ug/1 "Cholecystokinin
[Chemical/Ingredient],Cholecystokinin Analog [EPC]"
51808-204_71f96ee3-a363-4345-9ab6-5270ae323fab 51808-204 HUMAN PRESCRIPTI
ON DRUG Dipyridamole Dipridamole SOLUTION INTRAVENOUS
DIPYRIDAMOLE 5 mg/mL "Decreased Platelet Aggregation [PE],Platelet Ag
gregation Inhibitor [EPC]"
51808-206_25e39c45-5f86-400f-beab-63f773e54734 51808-206 HUMAN PRESCRIPTI
ON DRUG Isosulfan Blue Isosulfan Blue SOLUTION SUBCUTANEOUS
ISOSULFAN BLUE 10 mg/mL
51808-207_9292f201-2136-4da5-9d6f-0d7daca2de1e 51808-207 HUMAN PRESCRIPTI
ON DRUG Pentagastrin Pentagastrin SOLUTION INTRAVENOUS
PENTAGASTRIN 250 ug/1.6mL
51808-208_118e6927-25b5-4bcc-8716-fcb5dbdc487b 51808-208 HUMAN PRESCRIPTI
ON DRUG Sestamibi Sestamibi "INJECTION, POWDER, LYOPHILIZED,
AnazaoHealth Corporation TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) T
ETRAFLUOROBORATE 1.5 mg/1
51808-209_ad867c7e-d1fa-4587-9c3e-26a40fcf0ccc 51808-209 HUMAN PRESCRIPTI
ON DRUG Thyrotropin Releasing Hormone TRH Thyrotropin Releasing Hormone
SOLUTION INTRAVENOUS 20120619 UNAPPROVED DRUG OTHER
AnazaoHealth Corporation PROTIRELIN 500 ug/mL
51808-210_29c1fd45-7d77-4882-9e73-8a66742be742 51808-210 HUMAN PRESCRIPTI
ON DRUG Dextran 75 Dextran 75 "INJECTION, POWDER, LYOPHILIZED,
AnazaoHealth Corporation DEXTRAN 75 10 mg/1 "Plasma Volume E
xpander [EPC],Increased Intravascular Volume [PE],Osmotic Activity [MoA]"
51808-211_ec657ecb-6327-464c-8aab-6d61a0546b83 51808-211 HUMAN PRESCRIPTI
ON DRUG Dimercaptosuccinic Acid DMSA Dimercaptosuccinic Acid "INJECTION, POWD
ER, LYOPHILIZED, FOR SOLUTION" INTRAVENOUS 20120701 UNAPPROV
ED DRUG OTHER AnazaoHealth Corporation "2,3-DIMERCAPTOSUCCINIC
ACID" 1.1 mg/1
51808-213_fb2f24ff-01b1-4afe-9a24-dfa98fa1f047 51808-213 HUMAN PRESCRIPTI
ON DRUG Glucoheptonate Glucoheptonate "INJECTION, POWDER, LYOPHILIZED,
AnazaoHealth Corporation CALCIUM GLUCEPTATE 50 mg/1
51808-214_dd2d8053-37a4-465d-9086-2bd084c4898c 51808-214 HUMAN PRESCRIPTI
ON DRUG Exametazime HMPAO Exametazime "INJECTION, POWDER, LYOPHILIZED,
AnazaoHealth Corporation EXAMETAZIME 1 mg/1
51808-216_4d7406b4-8bcd-40f0-a31f-975f5b811da7 51808-216 HUMAN PRESCRIPTI
ON DRUG Mebrofenin Mebrofenin "INJECTION, POWDER, LYOPHILIZED,
AnazaoHealth Corporation MEBROFENIN 10 mg/1
51808-217_b780bd14-67f7-4dd6-8d36-f53a6d38152c 51808-217 HUMAN PRESCRIPTI
ON DRUG Bicisate Bicisate "INJECTION, POWDER, LYOPHILIZED,
AnazaoHealth Corporation BICISATE 1.35 mg/1
51808-218_e247d821-b132-4a87-a71a-8bc13c71fcfc 51808-218 HUMAN PRESCRIPTI
ON DRUG Pyrophosphate Pyrophosphate "INJECTION, POWDER, LYOPHILIZED,
AnazaoHealth Corporation SODIUM PYROPHOSPHATE 27.6 mg/1
51808-220_7c1f657a-07f0-4f9f-9552-1688174e2130 51808-220 HUMAN PRESCRIPTI
ON DRUG Sulfur Colloid Sulfur Colloid "INJECTION, POWDER, LYOPHILIZED,
AnazaoHealth Corporation GELATIN 4.5 mg/1
51808-223_0edc9a01-f669-4e7c-af14-cee9bfb3daa3 51808-223 HUMAN PRESCRIPTI
ON DRUG Tetrofosmin Tetrofosmin "INJECTION, POWDER, LYOPHILIZED,
AnazaoHealth Corporation TETROFOSMIN 0.35 mg/1
51808-223_89513168-46fb-471f-9566-e2240cedfa84 51808-223 HUMAN PRESCRIPTI
ON DRUG Tetrofosmin Tetrofosmin "INJECTION, POWDER, LYOPHILIZED,
AnazaoHealth Corporation TETROFOSMIN 0.35 mg/1
51803-001_43555ea1-944f-4371-a9e5-6c98316ce6d2 51803-001 HUMAN OTC DRUG
IOSAT Potassium Iodide TABLET ORAL 19821014
NDA NDA018664 Anbex Inc. POTASSIUM IODIDE 130 mg/1
51803-002_77ccaf76-1fc9-49fb-a163-49b080c91c33 51803-002 HUMAN OTC DRUG
IOSAT Potassium Iodide TABLET ORAL 20130501
NDA NDA018664 Anbex Inc. POTASSIUM IODIDE 65 mg/1
75974-100_64fa5e20-6161-4ce5-9ef8-70b10f6939cc 75974-100 HUMAN OTC DRUG
ANC Neverpain External Analgesic MENTHOL SPRAY TOPICAL 20110324
OTC MONOGRAPH NOT FINAL part348 ANC Amazon Natural Corp. MENTHOL 5
mL/100mL
10370-195_397470a1-b152-488d-bdd6-a582a0256c82 10370-195 HUMAN PRESCRIPTI
ON DRUG levetiracetam extended-release levetiracetam "TABLET, FILM CO
"Anchen Pharmaceuticals, Inc." LEVETIRACETAM 500 mg/1 "Anti-epileptic
E]"
10370-204_4b84993f-5722-489a-b04e-86654bef323b 10370-204 HUMAN PRESCRIPTI
"Anchen Pharmaceuticals, Inc." BUPROPION HYDROCHLORIDE 150 mg/1 "Aminoke
10370-214_397470a1-b152-488d-bdd6-a582a0256c82 10370-214 HUMAN PRESCRIPTI
ON DRUG levetiracetam extended-release levetiracetam "TABLET, FILM CO
"Anchen Pharmaceuticals, Inc." LEVETIRACETAM 750 mg/1 "Anti-epileptic
E]"
52559-575_37fb3e69-4cd9-431e-bc00-3878f091565a 52559-575 HUMAN OTC DRUG
Anchor Foaming Hand Sanitizer BENZETHONIUM CHLORIDE LIQUID TOPICAL
20100601 OTC MONOGRAPH NOT FINAL part333E Anchor Supply Co
mpany BENZETHONIUM CHLORIDE 2 mg/mL
52559-576_10d46c68-6a44-44a1-bf7a-b357f2b8aec7 52559-576 HUMAN OTC DRUG
Anchor Foaming Mango TRICLOSAN SOAP TOPICAL 20100401
OTC MONOGRAPH NOT FINAL part333E Anchor Supply Company TRICLOSAN
0.003 mL/mL
55560-0101_757dfc23-b1ba-4fb5-bfc4-fd771f4e155e 55560-0101 HUMAN OTC DRUG
Andalou BB Untinted with SPF-30 Zinc Oxide LOTION TOPICAL 20121210
OTC MONOGRAPH FINAL part352 Andalou naturals ZINC OXIDE 20
g/100mL
55560-0102_1520ddfd-7577-43ce-a2fe-caeacd81870f 55560-0102 HUMAN OTC DRUG
Andalou BB sheer tint with SPF-30 Zinc Oxide LOTION TOPICAL
20121210 OTC MONOGRAPH FINAL part352 Andalou naturals
ZINC OXIDE 20 g/100mL
50063-001_9e9ef7dc-51e9-48d2-a1ff-b2fea0537c32 50063-001 HUMAN PRESCRIPTI
NDA NDA205767 "Andy-Oxy Co., Inc." OXYGEN 995 mL/L
50063-002_5ea100db-60d2-4d06-abc3-45f59e21c5a1 50063-002 HUMAN PRESCRIPTI
20130101 NDA NDA205766 "Andy-Oxy Co., Inc." NITROGEN
992 mL/L
50063-003_40e3a56e-cc6b-4f13-b36c-a905108423fa 50063-003 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS "Andy-Oxy Co., Inc." AIR 1000 mL/L
43595-080_561c24c0-416a-4e45-abea-3e184a44e3b0 43595-080 HUMAN PRESCRIPTI
ON DRUG Oleptro Trazodone Hydrochloride "TABLET, EXTENDED RELEASE"
ORAL 20100202 NDA NDA022411 Angelini Pharma Inc.
43595-081_561c24c0-416a-4e45-abea-3e184a44e3b0 43595-081 HUMAN PRESCRIPTI
ON DRUG Oleptro Trazodone hydrochloride "TABLET, EXTENDED RELEASE"
ORAL 20100202 NDA NDA022411 Angelini Pharma Inc.
65974-162_ad24ba10-6133-49d5-8b14-0366cd58bf3e 65974-162 HUMAN PRESCRIPTI
ON DRUG Sotradecol Sodium Tetradecyl Sulfate "INJECTION, SOLU
TION" INTRAVENOUS 20041201 ANDA ANDA040541 Angiodyn
amics TETRADECYL HYDROGEN SULFATE (ESTER) 10 mg/mL
65974-163_ad24ba10-6133-49d5-8b14-0366cd58bf3e 65974-163 HUMAN PRESCRIPTI
ON DRUG Sotradecol Sodium Tetradecyl Sulfate "INJECTION, SOLU
TION" INTRAVENOUS 20041201 ANDA ANDA040541 Angiodyn
amics TETRADECYL HYDROGEN SULFATE (ESTER) 30 mg/mL
62559-280_f7f5b69a-c2a1-4586-a189-1475d41387c0 62559-280 HUMAN PRESCRIPTI
ON DRUG LITHOBID lithium carbonate "TABLET, FILM COATED, EX
TENDED RELEASE" ORAL 20140701 NDA NDA018027 "ANI Pha
rmaceuticals, Inc." LITHIUM CARBONATE 300 mg/1 Mood Stabilizer
[EPC]
24165-0001_195a2d37-39eb-98c1-8bd3-2759cd2d69d9 24165-0001 HUMAN OTC DRUG
Renew "Sanicula, Abrotanum, Argentum nitricum, Arsenicum album, Baryta
carbonica, Borax, Bryonia, Cactus grandiflorus, Calcarea fluorica, Calcarea pho
sphorica, Calcarea sulphurica, Chelidonium majus, Cholesterinum, Coffea cruda, C
onium maculatum, Dulcamara, Ferrum phosphoricum, Fumaria officinalis, Gratiola o
fficinalis, Helleborus niger, Hepar sulphuris calcareum, Hydrastis canadensis, H
ydrofluoricum acidum, Iodium, Kali carbonicum, Kali muriaticum, Kali phosphoricu
m, Kali sulphuricum, Lilium tigrinum" LIQUID ORAL 20140415
UNAPPROVED HOMEOPATHIC "Anila, Inc." "ARABICA COFFEE BEAN; ARSENIC TR
IOXIDE; ARTEMISIA ABROTANUM FLOWERING TOP; BARIUM CARBONATE; BRYONIA ALBA ROOT;
CALCIUM BICARBONATE; CALCIUM CHLORIDE; CALCIUM FLUORIDE; CALCIUM SULFATE ANHYDRO
US; CALCIUM SULFIDE; CHELIDONIUM MAJUS; CHOLESTEROL; CLAVICEPS PURPUREA SCLEROTI
UM; CONIUM MACULATUM FLOWERING TOP; FERROSOFERRIC PHOSPHATE; FUMARIA OFFICINALIS
FLOWERING TOP; GOLDENSEAL; GRATIOLA OFFICINALIS; HELLEBORUS NIGER ROOT; HYDROFL
UORIC ACID; IODINE; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPODIUM CLAVATUM SPOR
E; MAGNESIUM CHLORIDE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PHOSPHORUS; PODO
PHYLLUM; POTASSIUM CARBONATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC;
POTASSIUM SULFATE; PULSATILLA VULGARIS; SELENICEREUS GRANDIFLORUS STEM; SELENIUM
; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SILVER NITRATE; SMILAX REGELII ROOT;
SODIUM BICARBONATE; SODIUM BORATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC,
HEPTAHYDRATE; SODIUM SULFATE; SOLANUM DULCAMARA TOP; SPIGELIA ANTHELMIA; SULFUR;
TRIBASIC CALCIUM PHOSPHATE" 10; 10; 10; 10; 10; 15; 15; 10; 10; 10; 10; 10;
10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 15; 10;
10; 10; 10; 10; 10; 10; 15; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/mL; [hp_X
]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/m
_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]
/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [
hp_X]/mL; [hp_X]/mL
62559-110_d7db6cd8-b2d2-427f-bea7-94df998ffca5 62559-110 HUMAN PRESCRIPTI
ON DRUG Metoclopramide Metoclopramide SOLUTION ORAL 20110310
ANDA ANDA071402 ANIP Acquisition Company METOCLOPRAMIDE HYDROCHLO
RIDE 5 mg/5mL "Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antag
onist [EPC]"
62559-111_a307448a-ccc4-41a8-977a-11f28f0bded9 62559-111 HUMAN PRESCRIPTI
ON DRUG Cortenema Hydrocortisone ENEMA RECTAL 20120810
NDA NDA016199 ANIP Acquisition Company HYDROCORTISONE 100
62559-138_40654d12-56e4-4489-be49-19c60ad918ad 62559-138 HUMAN PRESCRIPTI
ON DRUG Hydrocortisone Hydrocortisone ENEMA RECTAL 20120816
NDA NDA017854 ANIP Acquisition Company HYDROCORTISONE 100
62559-149_5fd30aae-b052-4182-80e7-ad766bc3443a 62559-149 HUMAN PRESCRIPTI
ED DRUG OTHER ANIP Acquisition Company "ESTROGENS, ESTERIFIED;
METHYLTESTOSTERONE" 1.25; 2.5 mg/1; mg/1 "Androgen [EPC],Androgen
Receptor Agonists [MoA],Androstanes [Chemical/Ingredient]" CIII
62559-150_5fd30aae-b052-4182-80e7-ad766bc3443a 62559-150 HUMAN PRESCRIPTI
ED DRUG OTHER ANIP Acquisition Company "ESTROGENS, ESTERIFIED;
METHYLTESTOSTERONE" .625; 1.25 mg/1; mg/1 "Androgen [EPC],Androgen
Receptor Agonists [MoA],Androstanes [Chemical/Ingredient]" CIII
62559-153_bd6093ae-db19-437d-be34-50edafc29599 62559-153 HUMAN PRESCRIPTI
ON DRUG Opium tincture deodorized morphine tincture SOLUTION
ORAL 20110225 UNAPPROVED DRUG OTHER ANIP Acquisition
Company MORPHINE 1 g/100mL "Full Opioid Agonists [MoA],Opio
62559-158_713aca56-88bd-449f-bafa-ce9b02c8d509 62559-158 HUMAN PRESCRIPTI
ORAL 20110809 NDA AUTHORIZED GENERIC NDA021519 ANIP Acq
uisition Company FLUVOXAMINE MALEATE 25 mg/1 "Serotonin Reupt
62559-165_9277feb2-cab7-47fd-a0ab-b44bdc94ad57 62559-165 HUMAN PRESCRIPTI
ON DRUG Reglan Metoclopramide Hydrochloride TABLET ORAL 20110705
NDA NDA017854 ANIP Acquisition Company METOCLOPRAMIDE HYDROCHLO
onist [EPC]"
62559-166_9277feb2-cab7-47fd-a0ab-b44bdc94ad57 62559-166 HUMAN PRESCRIPTI
ON DRUG Reglan Metoclopramide Hydrochloride TABLET ORAL 20110705
NDA NDA017854 ANIP Acquisition Company METOCLOPRAMIDE HYDROCHLO
onist [EPC]"
69148-001_01867a4d-1d9b-4ffc-aa1d-80675a1b8219 69148-001 HUMAN OTC DRUG
ARC Skin Protectant ALLANTOIN OINTMENT TOPICAL 20140806
OTC MONOGRAPH FINAL part347 "Anjon Biologics, Inc" ALLANTOIN 0.5
g/100g
59713-001_252e4485-ea4a-4942-a585-977984250be2 59713-001 HUMAN PRESCRIPTI
ON DRUG Oxygen Oxygen GAS RECTAL 19920701 UNAPPROV
ED MEDICAL GAS "Ann Arbor Welding Supply Co., Inc. DBA Arbor Specialty
Gases" OXYGEN 990 mL/L
76446-001_27b238db-0a0e-4591-8668-6ca1d2ef6ab7 76446-001 HUMAN OTC DRUG
Anna Lotan Triple Benefit Tinted Moisturizing Day Broad Spectrum SPF 30
"OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE" CREAM TOPICAL 20120119
OTC MONOGRAPH FINAL part352 Anna Lotan Ltd OCTINOXATE; OXYBENZONE; TITANIUM
DIOXIDE 7.5; 2.5; 6.65 mL/100mL; mL/100mL; mL/100mL
76446-002_1d1b99c6-cf1a-4c46-bf5b-90b8e43c07c3 76446-002 HUMAN OTC DRUG
ANNA LOTAN Premium B.B. UVA UVB SPF 36 "TITANIUM DIOXIDE, OCTINOXATE"
CREAM TOPICAL 20120616 OTC MONOGRAPH FINAL part352 Anna Lot
an Ltd OCTINOXATE; TITANIUM DIOXIDE 15; 30 mL/100mL; mL/100mL
76446-003_a541893c-e891-4f26-adbb-a7e9da4b341b 76446-003 HUMAN OTC DRUG
ANNA LOTAN Clear Protector Free Broad Spectrum SPF 32 Sunscreen "HOMOSAL
ATE, OCTISALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE" GEL TOPICAL 20120616
OTC MONOGRAPH FINAL part352 Anna Lotan Ltd AVOBENZONE; HOMOSALATE; OCTISALA
TE; OCTOCRYLENE; OXYBENZONE 3; 7.5; 5; 2.75; 4 mL/100mL; mL/100mL; mL/1
00mL; mL/100mL; mL/100mL
76446-004_a5fe9557-9e8e-4c54-9eb1-d419892ca74b 76446-004 HUMAN OTC DRUG
ANNA LOTAN Rejuvenating Day Broad Spectrum SPF 34 "OCTINOXATE, TIT
ANIUM DIOXIDE" CREAM TOPICAL 20120619 OTC MONOGRAPH FINAL
part352 Anna Lotan Ltd OCTINOXATE; TITANIUM DIOXIDE 7.5; 4.4 mL/100mL
; mL/100mL
76446-005_d6b3298e-b647-4eb3-9abe-c0dfacde3ef6 76446-005 HUMAN OTC DRUG
anna lotan PRO CC Color Control SPF25 Broad Spectrum Protection for All Skin Typ
es "TITANIUM DIOXIDE, OCTINOXATE" CREAM TOPICAL 20131111
OTC MONOGRAPH FINAL part352 Anna Lotan Ltd OCTINOXATE; TITANIUM DIOXIDE
75; 110 mg/mL; mg/mL
76446-006_2c9dd40c-bfdd-4793-b2e1-8f695f5a3de3 76446-006 HUMAN OTC DRUG
anna lotan PRO PORCELAIN COVER SPF32 Tinted with Broad Spectrum Protection for A
ll Skin Types "TITANIUM DIOXIDE, OCTINOXATE" LOTION TOPICAL 20131111
OTC MONOGRAPH FINAL part352 Anna Lotan Ltd OCTINOXATE; TITANIUM DIOXIDE
75; 134 mg/mL; mg/mL
76446-007_1e6a2703-6fdb-4e1d-9887-afb0c2a2a569 76446-007 HUMAN OTC DRUG
anna lotan PRO Protective LIGHTENING CARE UVA/UVB SPF 15 For Sun Damaged Skin
"OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE" CREAM TOPICAL 20131111
OTC MONOGRAPH FINAL part352 Anna Lotan Ltd OCTINOXATE; OXYBENZONE; TITANIUM
DIOXIDE 70; 30; 21 mg/mL; mg/mL; mg/mL
10188-001_2b115f8a-d617-47b2-843b-88708f4d615a 10188-001 HUMAN OTC DRUG
LifeStyles EPIC Male Genital Desensitizer LIDOCAINE SPRAY
TOPICAL 20111102 OTC MONOGRAPH FINAL part348 Ansell Healthcar
e Inc LIDOCAINE 10 mg/.1mL
54436-010_b3ca9e13-bbc3-4eff-9065-12c8cf0cee89 54436-010 HUMAN PRESCRIPTI
ON DRUG Otrexup methotrexate "INJECTION, SOLUTION" SUBCUTANEOUS
20131011 NDA NDA204824 "Antares Pharma, Inc." METHOTRE
XATE 10 mg/.4mL "Folate Analog Metabolic Inhibitor [EPC],Folic Acid Meta
bolism Inhibitors [MoA]"
49288-0001_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0001 HUMAN PRESCRIPTI
ON DRUG Alternaria alternata Alternaria alternata "INJECTION, SOLU
TION" INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA10222
3 "Antigen Laboratories, Inc." ALTERNARIA ALTERNATA 0.1 g/mL
ON DRUG A Mold Mixture A Mold Mixture "INJECTION, SOLUTION" INTRADER
MAL; SUBCUTANEOUS 19920413 BLA BLA102223 "Antigen
Laboratories, Inc." ASPERGILLUS FLAVUS; ASPERGILLUS FUMIGATUS; ASPERGILLUS N
IGER VAR. NIGER; ASPERGILLUS REPENS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; BOT
RYTIS CINEREA; CANDIDA TROPICALIS; CHAETOMIUM GLOBOSUM; COCHLIOBOLUS SATIVUS; EP
ICOCCUM NIGRUM; FUSARIUM OXYSPORUM; GEOTRICHUM CANDIDUM; MUCOR PLUMBEUS; MUCOR R
ACEMOSUS; NEUROSPORA INTERMEDIA; PENICILLIUM CAMEMBERTI; PENICILLIUM CHRYSOGENUM
VAR. CHRYSOGENUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM EXPANSU
M; PENICILLIUM ITALICUM; PENICILLIUM ROQUEFORTI; PHOMA DESTRUCTIVA; RHIZOPUS STO
LONIFER; RHIZOPUS STOLONIFER; RHODOTORULA RUBRA; SACCHAROMYCES CEREVISIAE
.0017; .0017; .0017; .0017; .0067; .0067; .0033; .0067; .0067; .0067; .0067; .00
67; .0022; .0022; .0033; .0011; .0011; .0011; .0011; .0011; .0011; .0067; .0022;
.0067; .0067; .0067 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/
mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL
; g/mL; g/mL; g/mL "Non-Standardized Fungal Allergenic Extract [EPC],Increa
sed Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical
/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic
Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Funga
l Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardize
t],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [E
PC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG P
e [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins
[Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal A
[PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allerge
ns [Chemical/Ingredient],Increased IgG Production [PE],Fungal Proteins [Chemical
Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Non-S
ased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemic
al/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histam
ine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Funga
ns [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increa
PC]"
.0008; .0008; .0008; .0008; .0033; .0033; .0017; .0033; .0033; .0033; .0033; .00
33; .0011; .0011; .0017; .0006; .0006; .0006; .0006; .0006; .0006; .0033; .0011;
PC]"
.0004; .0004; .0004; .0004; .0017; .0017; .0008; .0017; .0017; .0017; .0017; .00
17; .0006; .0006; .0008; .0003; .0003; .0003; .0003; .0003; .0003; .0017; .0006;
PC]"
ON DRUG Aspergillus Mixture Aspergillus Mixture "INJECTION, SOLU
3 "Antigen Laboratories, Inc." ASPERGILLUS FLAVUS; ASPERGILLUS FUMIGATU
S; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS .0025; .0025; .0025; .00
25 g/mL; g/mL; g/mL; g/mL "Non-Standardized Fungal Allergenic Extract [EPC
],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [
/Ingredient]"
ON DRUG Aspergillus Mixture Aspergillus Mixture "INJECTION, SOLU
3 "Antigen Laboratories, Inc." ASPERGILLUS FLAVUS; ASPERGILLUS FUMIGATU
S; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS .0125; .0125; .0125; .01
25 g/mL; g/mL; g/mL; g/mL "Non-Standardized Fungal Allergenic Extract [EPC
/Ingredient]"
49288-0009_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0009 HUMAN PRESCRIPTI
ON DRUG Almond Almond "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
S 19740323 BLA BLA102223 "Antigen Laboratories, I
nc." ALMOND 0.05 g/mL "Non-Standardized Food Allergenic Extract [EPC],
dient]"
ON DRUG Apple Apple "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." APPLE 0.05 g/mL "Allergens [Chemical/Ingredient],Dietary Protein
s [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient],Non-Standardized Fo
od Allergenic Extract [EPC],Increased Histamine Release [PE]"
ON DRUG Apricot Apricot "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." APRICOT 1 mL/mL "Non-Standardized Food Allergenic Extract [EPC],
Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Dietary Protein
s [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient]"
ON DRUG Asparagus Asparagus "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." ASPARAGUS 0.05 g/mL "Non-Standardized Food A
ON DRUG Avocado Avocado "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." AVOCADO 0.05 g/mL "Non-Standardized Food Allergenic Extract [EPC],
redient]"
49288-0014_13c9eea1-38b5-472b-b735-a814ca886718 49288-0014 HUMAN PRESCRIPTI
ON DRUG Acacia Pollen Acacia Pollen "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." ACACIA BAILEYANA POLLEN 0.05 g/mL "Non-Standardize
ON DRUG Smooth (Tag) Alder Smooth (Tag) Alder "INJECTION, SOLU
3 "Antigen Laboratories, Inc." ALNUS INCANA SUBSP. RUGOSA POLLEN
ON DRUG White Alder White Alder "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." ALNUS RHOMBIFOLIA POLLEN 0.05 g/mL "Non-Sta
ON DRUG Ash Mixture Ash Mixture "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." FRAXINUS AMERICANA POLLEN; FRAXINUS PENNSYLVANICA POLLEN
.025; .025 g/mL; g/mL "Non-Standardized Pollen Allergenic Extract [EPC
duction [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-St
andardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell
-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredien
ON DRUG Ash Mixture Ash Mixture "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." FRAXINUS AMERICANA POLLEN; FRAXINUS PENNSYLVANICA POLLEN
.01; .01 g/mL; g/mL "Non-Standardized Pollen Allergenic Extract [EPC
ON DRUG Arizona Ash Arizona Ash "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." FRAXINUS VELUTINA POLLEN 0.05 g/mL "Non-Sta
ON DRUG Oregon Ash Oregon Ash "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." FRAXINUS LATIFOLIA POLLEN 0.05 g/mL "Non-Sta
ON DRUG White Ash White Ash "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." FRAXINUS AMERICANA POLLEN 0.1 g/mL "Non-Sta
ON DRUG White Ash White Ash "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." FRAXINUS AMERICANA POLLEN 0.05 g/mL "Non-Sta
ON DRUG Aspen Pollen Aspen Pollen "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." POPULUS TREMULOIDES POLLEN 0.05 g/mL "Non-Sta
49288-0024_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0024 HUMAN PRESCRIPTI
ON DRUG Western Water Hemp Western Water Hemp "INJECTION, SOLU
3 "Antigen Laboratories, Inc." AMARANTHUS TUBERCULATUS POLLEN 0.05
hemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased H
istamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],
Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
ON DRUG Careless Weed Careless Weed "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." AMARANTHUS PALMERI POLLEN 0.05 g/mL "Non-Sta
nt]"
ON DRUG Wingscale Wingscale "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." ATRIPLEX CANESCENS POLLEN 0.05 g/mL "Non-Sta
ON DRUG Shadscale Shadscale "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." ATRIPLEX CONFERTIFOLIA POLLEN 0.05 g/mL "Non-Sta
ON DRUG Lenscale Lenscale "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." ATRIPLEX LENTIFORMIS POLLEN 0.05 g/mL "Non-Sta
ON DRUG Alfalfa Pollen Alfalfa Pollen "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." MEDICAGO SATIVA POLLEN 0.05 g/mL "Non-Standardize
ON DRUG Aspergillus fumigatus Aspergillus fumigatus "INJECTION, SOLU
3 "Antigen Laboratories, Inc." ASPERGILLUS FUMIGATUS 0.1 g/mL
ON DRUG Aspergillus fumigatus Aspergillus fumigatus "INJECTION, SOLU
3 "Antigen Laboratories, Inc." ASPERGILLUS FUMIGATUS 0.05 g/mL
ON DRUG Aspergillus niger Aspergillus niger "INJECTION, SOLU
3 "Antigen Laboratories, Inc." ASPERGILLUS NIGER VAR. NIGER 0.1
ON DRUG Aspergillus niger Aspergillus niger "INJECTION, SOLU
3 "Antigen Laboratories, Inc." ASPERGILLUS NIGER VAR. NIGER 0.05
ON DRUG Atriplex Mixture Atriplex Mixture "INJECTION, SOLU
3 "Antigen Laboratories, Inc." ATRIPLEX CANESCENS POLLEN; ATRIPLEX LENT
IFORMIS POLLEN; ATRIPLEX POLYCARPA POLLEN; ATRIPLEX WRIGHTII POLLEN .0125; .
0125; .0125; .0125 g/mL; g/mL; g/mL; g/mL "Non-Standardized Pollen Allerge
ON DRUG B Mold Mixture B Mold Mixture "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." COCHLIOBOLUS SPICIFER; COLLETOTRICHUM COCCODES; HYPOMYCE
S PERNICIOSUS; KHUSKIA ORYZAE; MICROASCUS BREVICAULIS; MYROTHECIUM VERRUCARIA; N
EUROSPORA CRASSA; PAECILOMYCES VARIOTII; PASSALORA FULVA; PLEOSPORA HERBARUM; ST
REPTOMYCES GRISEUS; TRICHODERMA VIRIDE; TRICHOPHYTON SCHOENLEINII; TRICHOTHECIUM
ROSEUM .0071; .0071; .0071; .0071; .0071; .0071; .0071; .0071; .0071; .0071; .0
071; .0071; .0071; .0071 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL;
g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Non-Standardized Fungal Allergenic Extr
ngredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine
Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Pr
oteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fu
ngal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Imm
unity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],A
llergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],
ction [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient]
,Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [P
emical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Aller
,Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [
,Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Stand
ardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-me
oteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Ba
cterial Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated
Immunity [PE],Increased IgG Production [PE],Bacterial Proteins [Chemical/Ingredi
ent],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract
[EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG
Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingre
dient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Rele
ase [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Protei
ns [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
ROSEUM .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0
ROSEUM .0018; .0018; .0018; .0018; .0018; .0018; .0018; .0036; .0018; .0018; .0
ON DRUG Botrytis Botrytis "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." BOTRYTIS CINEREA 0.1 g/mL "Non-Standardize
ON DRUG Botrytis Botrytis "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." BOTRYTIS CINEREA 0.05 g/mL "Non-Standardize
ON DRUG Banana Banana "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." BANANA 0.05 g/mL "Non-Standardized Food Allergenic Extract [EPC],
redient]"
ON DRUG Basil Basil "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." BASIL 0.05 g/mL "Non-Standardized Plant Allergenic Extract [EPC]
l/Ingredient]"
ON DRUG Whole Grain Barley Whole Grain Barley "INJECTION, SOLU
3 "Antigen Laboratories, Inc." BARLEY 0.05 g/mL "Non-Standardize
nt],Grain Proteins [Chemical/Ingredient]"
ON DRUG Lima Bean Lima Bean "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." LIMA BEAN 0.05 g/mL "Non-Standardized Food A
ON DRUG Mung Bean Mung Bean "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." MUNG BEAN 0.05 g/mL "Non-Standardized Plant
,Seed Storage Proteins [Chemical/Ingredient]"
ON DRUG Navy Bean Navy Bean "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." KIDNEY BEAN 0.05 g/mL "Non-Standardized Plant
ON DRUG Pinto Bean Pinto Bean "INJECTION, SOLUTION" INTRADER
ON DRUG Green (Sting) Bean Green (String) Bean "INJECTION, SOLU
3 "Antigen Laboratories, Inc." STRING BEAN 0.05 g/mL "Non-Sta
ON DRUG Soybean Soybean "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." SOYBEAN 0.05 g/mL "Non-Standardized Food Allergenic Extract [EPC],
/Ingredient]"
ON DRUG Broccoli Broccoli "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." BROCCOLI 0.05 g/mL "Non-Standardized Food A
ON DRUG Brussels Sprout Brussels Sprout "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." BRUSSELS SPROUT 0.05 g/mL "Non-Standardized Plant
ON DRUG Buckwheat Buckwheat "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." BUCKWHEAT 0.05 g/mL "Non-Standardized Food A
[PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grai
n Proteins [Chemical/Ingredient]"
ON DRUG Beet Beet "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." BEET 0.05 g/mL "Non-Standardized Plant Allergenic Extract [EPC]
hemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Che
mical/Ingredient]"
ON DRUG Brazil Nut Meat Brazil Nut Meat "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." BRAZIL NUT 0.05 g/mL "Non-Standardized Food A
[PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut
ON DRUG Blackberry Blackberry "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." BLACKBERRY 0.05 g/mL
ON DRUG Blueberry Blueberry "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." BLUEBERRY 0.05 g/mL
ON DRUG Birch Mixture Birch Mixture "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." BETULA ALLEGHANIENSIS POLLEN; BETULA LENTA POLLEN; BETUL
A NIGRA POLLEN; BETULA OCCIDENTALIS POLLEN; BETULA PAPYRIFERA POLLEN; BETULA POP
ULIFOLIA POLLEN .0083; .0083; .0083; .0083; .0083; .0083 g/mL; g/mL; g/mL
; g/mL; g/mL; g/mL "Non-Standardized Pollen Allergenic Extract [EPC],Increa
[PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardiz
ed Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediate
d Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Aller
gens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Incr
eased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Productio
n [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standard
ized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-media
ted Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],All
ergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],In
ion [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standa
ON DRUG Birch Mixture Birch Mixture "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." BETULA ALLEGHANIENSIS POLLEN; BETULA LENTA POLLEN; BETUL
A NIGRA POLLEN; BETULA OCCIDENTALIS POLLEN; BETULA PAPYRIFERA POLLEN; BETULA POP
ULIFOLIA POLLEN .0033; .0033; .0033; .0033; .0033; .0033 g/mL; g/mL; g/mL
ON DRUG Spring (Water) Birch Spring (Water) Birch "INJECTION, SOLU
3 "Antigen Laboratories, Inc." BETULA OCCIDENTALIS POLLEN 0.05
ON DRUG Box Elder Box Elder "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." ACER NEGUNDO POLLEN 0.1 g/mL "Non-Standardize
ON DRUG Box Elder Box Elder "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." ACER NEGUNDO POLLEN 0.05 g/mL "Non-Standardize
ON DRUG Kidney Bean Kidney Bean "INJECTION, SOLUTION" INTRADER
49288-0062_0247493a-8221-44f5-afa6-071bde3bfac2 49288-0062 HUMAN PRESCRIPTI
ON DRUG Canadian Bluegrass Canadian Bluegrass "INJECTION, SOLU
3 "Antigen Laboratories, Inc." POA COMPRESSA POLLEN 0.05 g/mL
49288-0063_bb0c98b2-aaa8-49c4-887a-928e3937769c 49288-0063 HUMAN PRESCRIPTI
ON DRUG Standardized Bermuda Grass Pollen Standardized Bermuda Gra
ss Pollen "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOUS 19970613
BLA BLA102226 "Antigen Laboratories, Inc." CYNODON DACTYLON POLLEN
ON DRUG Bermuda Grass Smut Bermuda Grass Smut "INJECTION, SOLU
3 "Antigen Laboratories, Inc." USTILAGO CYNODONTIS 0.1 g/mL
ON DRUG Bermuda Grass Smut Bermuda Grass Smut "INJECTION, SOLU
3 "Antigen Laboratories, Inc." USTILAGO CYNODONTIS 0.05 g/mL
ON DRUG Barley Smut Barley Smut "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." USTILAGO NUDA HORDEI 0.05 g/mL "Non-Standardize
ON DRUG Annual Bluegrass Annual Bluegrass "INJECTION, SOLU
3 "Antigen Laboratories, Inc." POA ANNUA POLLEN 0.05 g/mL
ON DRUG Cheat Brome Grass Cheat Brome Grass "INJECTION, SOLU
3 "Antigen Laboratories, Inc." BROMUS SECALINUS POLLEN 0.05 g/mL
ON DRUG Smooth Brome Grass Smooth Brome Grass "INJECTION, SOLU
3 "Antigen Laboratories, Inc." BROMUS INERMIS POLLEN 0.05 g/mL
t]"
49288-0070_ab729e90-03ec-4b3a-8c11-390b49ff5173 49288-0070 HUMAN PRESCRIPTI
ON DRUG Beef Beef "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." BEEF 0.05 g/mL "Non-Standardized Food Allergenic Extract [EPC],
edient]"
ON DRUG Bay Leaf Bay Leaf "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." LAURUS NOBILIS 0.05 g/mL
ON DRUG Paperbark Birch Paperbark Birch "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." BETULA PAPYRIFERA POLLEN 0.05 g/mL "Non-Sta
ON DRUG American Beech American Beech "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." FAGUS GRANDIFOLIA POLLEN 0.05 g/mL "Non-Sta
ON DRUG Bahia Grass Bahia Grass "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." PASPALUM NOTATUM POLLEN 0.1 g/mL "Non-Standardize
ON DRUG Bahia Grass Bahia Grass "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." PASPALUM NOTATUM POLLEN 0.05 g/mL "Non-Standardize
ON DRUG Groundsel Tree Groundsel Tree "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." BACCHARIS HALIMIFOLIA POLLEN 0.05 g/mL "Non-Sta
ON DRUG Red (River) Birch Red (River) Birch "INJECTION, SOLU
3 "Antigen Laboratories, Inc." BETULA NIGRA POLLEN 0.1 g/mL
ON DRUG Red (River) Birch Red (River) Birch "INJECTION, SOLU
3 "Antigen Laboratories, Inc." BETULA NIGRA POLLEN 0.05 g/mL
49288-0079_bffa4c39-d658-4a1c-b00a-3f0c411fa524 49288-0079 HUMAN PRESCRIPTI
ON DRUG Bayberry Pollen Bayberry Pollen "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." MORELLA CERIFERA POLLEN 0.05 g/mL "Non-Standardize
ON DRUG White Birch White Birch "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." BETULA POPULIFOLIA POLLEN 0.05 g/mL "Non-Sta
ON DRUG Sugar Beet Pollen Sugar Beet Pollen "INJECTION, SOLU
3 "Antigen Laboratories, Inc." BETA VULGARIS POLLEN 0.05 g/mL
ON DRUG Eastern Cottonwood Eastern Cottonwood "INJECTION, SOLU
3 "Antigen Laboratories, Inc." POPULUS DELTOIDES POLLEN 0.1
ON DRUG Chenopodium Mixture Chenopodium Mixture "INJECTION, SOLU
3 "Antigen Laboratories, Inc." CHENOPODIUM ALBUM POLLEN; CHENOPODIUM AM
BROSIOIDES POLLEN; CHENOPODIUM BOTRYS POLLEN .0167; .0167; .0167 g/mL; g/
mL; g/mL "Non-Standardized Pollen Allergenic Extract [EPC],Increased Hist
emical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Hi
stamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],P
ollen [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
ON DRUG Chenopodium Mixture Chenopodium Mixture "INJECTION, SOLU
3 "Antigen Laboratories, Inc." CHENOPODIUM ALBUM POLLEN; CHENOPODIUM AM
BROSIOIDES POLLEN; CHENOPODIUM BOTRYS POLLEN .0067; .0067; .0067 g/mL; g/
ON DRUG Cephalosporium Cephalosporium "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." ACREMONIUM STRICTUM 0.1 g/mL "Non-Standardize
ON DRUG C Mold Mixture C Mold Mixture "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." ACROTHECIUM ROBUSTUM; APIOSPORA MONTAGNEI; HUMICOLA GRIS
EA; MICROSPORUM AUDOUINII; MICROSPORUM CANIS; MYCOCLADUS CORYMBIFERUS; PHYCOMYCE
S BLAKESLEEANUS; SPOROTRICHUM PRUINOSUM; STACHYBOTRYS CHARTARUM; SYNCEPHALASTRUM
RACEMOSUM; TETRACOCCOSPORIUM PAXIANUM; VERTICILLIUM ALBO-ATRUM .0083; .0083; .0
083; .0083; .0083; .0083; .0083; .0083; .0083; .0083; .0083; .0083 g/mL; g/
mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Non-Standardize
l-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemic
042; .0042; .0042; .0042; .0042; .0042; .0042; .0042; .0042; .0042 g/mL; g/
021; .0021; .0021; .0021; .0021; .0021; .0021; .0021; .0021; .0021 g/mL; g/
ON DRUG Chaetomium Chaetomium "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." CHAETOMIUM GLOBOSUM 0.1 g/mL "Non-Standardize
ON DRUG Chaetomium Chaetomium "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." CHAETOMIUM GLOBOSUM 0.05 g/mL "Non-Standardize
ON DRUG Cephalothecium Cephalothecium "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." TRICHOTHECIUM ROSEUM 0.05 g/mL "Non-Standardize
ON DRUG Cladosporium fulvum Cladosporium fulvum "INJECTION, SOLU
3 "Antigen Laboratories, Inc." PASSALORA FULVA 0.05 g/mL "Non-Sta
ON DRUG Curvularia Curvularia "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." COCHLIOBOLUS SPICIFER 0.1 g/mL "Non-Standardize
ON DRUG Curvularia Curvularia "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." COCHLIOBOLUS SPICIFER 0.05 g/mL "Non-Standardize
ON DRUG Corn Corn "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." CORN 0.05 g/mL "Non-Standardized Food Allergenic Extract [EPC],
redient]"
49288-0100_afc65820-1d95-4bc6-81a6-ef5ca82cbd81 49288-0100 HUMAN PRESCRIPTI
ON DRUG Coffee Coffee "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." ARABICA COFFEE BEAN 0.05 g/mL "Non-Standardized Food Allergeni
tary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed St
orage Proteins [Chemical/Ingredient]"
ON DRUG Cabbage Cabbage "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." CABBAGE 0.05 g/mL "Non-Standardized Food Allergenic Extract [EPC],
/Ingredient]"
ON DRUG Cantaloupe Cantaloupe "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." CANTALOUPE 0.05 g/mL "Non-Standardized Food A
49288-0103_28463a0e-70af-4169-b592-df65f4f13a5f 49288-0103 NON-STANDARDIZED
ALLERGENIC Carp Carp "INJECTION, SOLUTION" INTRADERMAL; SUB
CUTANEOUS 19740323 BLA BLA102223 "Antigen Laborat
ories, Inc." COMMON CARP 0.05 g/mL "Non-Standardized Food Allergeni
s, Dietary [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],
ical/Ingredient]"
ON DRUG Carrot Carrot "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." CARROT 0.05 g/mL "Non-Standardized Food Allergenic Extract [EPC],
/Ingredient]"
ON DRUG Cashew Nut Meat Cashew Nut Meat "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." CASHEW 0.05 g/mL "Non-Standardized Food Allergeni
ergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins
ALLERGENIC Catfish Catfish "INJECTION, SOLUTION" INTRADERMAL; SUB
ories, Inc." WHITE CATFISH 0.05 g/mL "Non-Standardized Food Allergeni
ON DRUG Cauliflower Cauliflower "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." CAULIFLOWER 0.05 g/mL "Non-Standardized Plant
ON DRUG Celery Celery "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." CELERY 0.05 g/mL "Non-Standardized Food Allergenic Extract [EPC],
/Ingredient]"
49288-0109_80e3a713-b3c2-4981-9f01-d987196bc528 49288-0109 HUMAN PRESCRIPTI
ON DRUG Carob Carob "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." CAROB 0.05 g/mL "Non-Standardized Plant Allergenic Extract [EPC]
l/Ingredient]"
ON DRUG Cherry Cherry "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." SWEET CHERRY 0.05 g/mL
ALLERGENIC Clam Clam "INJECTION, SOLUTION" INTRADERMAL; SUB
ories, Inc." QUAHOG 0.05 g/mL "Non-Standardized Food Allergenic Extrac
Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [
ON DRUG Clove Clove "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." CLOVE 0.05 g/mL "Non-Standardized Plant Allergenic Extract [EPC]
l/Ingredient]"
ON DRUG Chicken Chicken "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." CHICKEN 0.05 g/mL "Non-Standardized Food Allergenic Extract [EPC],
/Ingredient],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Chemical/I
ngredient]"
ON DRUG Cinnamon Cinnamon "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." CINNAMON 0.05 g/mL "Non-Standardized Food A
[PE],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient]
ON DRUG Whole Bean Cacao Whole Bean Cacao "INJECTION, SOLU
3 "Antigen Laboratories, Inc." COCOA BEAN 0.05 g/mL "Non-Sta
ON DRUG Cottonseed Cottonseed "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." COTTON SEED 0.05 g/mL "Non-Standardized Plant
Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity
[PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Protei
ns [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient]"
ON DRUG Cranberry Cranberry "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." CRANBERRY 0.05 g/mL "Non-Standardized Food A
ON DRUG Cucumber Cucumber "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." CUCUMBER 0.05 g/mL "Non-Standardized Food A
ALLERGENIC Crab Crab "INJECTION, SOLUTION" INTRADERMAL; SUB
ories, Inc." OPILIO CRAB 0.05 g/mL
ON DRUG Coconut Coconut "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." COCONUT 0.05 g/mL "Non-Standardized Food Allergenic Extract [EPC],
redient]"
49288-0121_bc075035-e18d-4cbd-be9d-d4d75cb7c2d1 49288-0121 HUMAN PRESCRIPTI
ON DRUG Standardized Cat Hair Standardized Cat Hair "INJECTION, SOLU
8 "Antigen Laboratories, Inc." FELIS CATUS HAIR 10000 [BAU]/mL
cal/Ingredient]"
49288-0122_bc075035-e18d-4cbd-be9d-d4d75cb7c2d1 49288-0122 HUMAN PRESCRIPTI
ON DRUG Standardized Cat Hair Standardized Cat Hair "INJECTION, SOLU
8 "Antigen Laboratories, Inc." FELIS CATUS HAIR 5000 [BAU]/mL
cal/Ingredient]"
49288-0123_f08d6882-f5d5-4109-b9df-64c85e82a0a1 49288-0123 HUMAN PRESCRIPTI
ON DRUG Cattle Hair Cattle Hair "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." BOS TAURUS HAIR 0.1 g/mL "Non-Standardized Animal
Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Im
munity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fur [C
ON DRUG Cattle Hair Cattle Hair "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." BOS TAURUS HAIR 0.05 g/mL "Non-Standardized Animal
munity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fur [C
ON DRUG Chicken Feather Chicken Feather "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." GALLUS GALLUS FEATHER 0.05 g/mL "Non-Standardize
ON DRUG Chicken Feather Chicken Feather "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." GALLUS GALLUS FEATHER 0.02 g/mL "Non-Standardize
ON DRUG Canary Feather Canary Feather "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." SERINUS CANARIA FEATHER 0.02 g/mL "Increased Hista
mine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feat
hers [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],All
ON DRUG Mountain Cedar Mountain Cedar "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." JUNIPERUS ASHEI POLLEN 0.1 g/mL "Non-Standardize
ON DRUG Redberry Juniper Redberry Juniper "INJECTION, SOLU
3 "Antigen Laboratories, Inc." JUNIPERUS PINCHOTII POLLEN 0.05
ON DRUG Red Cedar Red Cedar "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." JUNIPERUS VIRGINIANA POLLEN 0.05 g/mL "Non-Sta
ON DRUG Salt Cedar Salt Cedar "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." TAMARIX GALLICA POLLEN 0.05 g/mL "Non-Standardize
ON DRUG Black Cottonwood Black Cottonwood "INJECTION, SOLU
3 "Antigen Laboratories, Inc." POPULUS BALSAMIFERA SUBSP. TRICHOCARPA P
OLLEN 0.05 g/mL "Non-Standardized Pollen Allergenic Extract [EPC],Increa
ON DRUG Western Cottonwood Western Cottonwood "INJECTION, SOLU
3 "Antigen Laboratories, Inc." POPULUS DELTOIDES SUBSP. MONILIFERA POLL
ON DRUG Arizona Cypress Arizona Cypress "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." CUPRESSUS ARIZONICA POLLEN 0.05 g/mL "Non-Sta
ON DRUG Lambs Quarters Lambs Quarters "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." CHENOPODIUM ALBUM POLLEN 0.1 g/mL "Non-Sta
ON DRUG Lambs Quarters Lambs Quarters "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." CHENOPODIUM ALBUM POLLEN 0.05 g/mL "Non-Sta
ON DRUG Cocklebur Cocklebur "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." XANTHIUM STRUMARIUM POLLEN 0.1 g/mL "Non-Sta
ON DRUG Cocklebur Cocklebur "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." XANTHIUM STRUMARIUM POLLEN 0.05 g/mL "Non-Sta
ON DRUG Corn Pollen Corn Pollen "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." ZEA MAYS POLLEN 0.05 g/mL "Non-Standardized Pollen
mical/Ingredient]"
ON DRUG Sweet Clover Mixture Sweet Clover Mixture "INJECTION, SOLU
3 "Antigen Laboratories, Inc." MELILOTUS ALBUS POLLEN; MELILOTUS OFFICI
NALIS POLLEN .025; .025 g/mL; g/mL "Non-Standardized Pollen Allerge
ON DRUG Corn Smut Corn Smut "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." USTILAGO MAYDIS 0.05 g/mL "Non-Standardized Fungal
ON DRUG Bald Cypress Bald Cypress "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." TAXODIUM DISTICHUM POLLEN 0.05 g/mL "Non-Sta
ON DRUG Reed Canary Grass Reed Canary Grass "INJECTION, SOLU
3 "Antigen Laboratories, Inc." PHALARIS ARUNDINACEA POLLEN 0.05
ON DRUG Cattail Cattail "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." TYPHA LATIFOLIA POLLEN 0.05 g/mL "Non-Standardized Pollen Allerge
gredient]"
ALLERGENIC Cod Cod "INJECTION, SOLUTION" INTRADERMAL; SUB
ories, Inc." ATLANTIC COD 0.05 g/mL "Non-Standardized Food Allergeni
49288-0148_0c2a583c-28b8-4184-9f4d-9feba1e683c9 49288-0148 HUMAN PRESCRIPTI
ON DRUG American Cockroach American Cockroach "INJECTION, SOLU
3 "Antigen Laboratories, Inc." PERIPLANETA AMERICANA 0.1 g/mL
ON DRUG Currant Currant "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." RED CURRANT 0.05 g/mL "Non-Standardized Plant Allergenic Extra
teins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives
ON DRUG Caraway Seed Caraway Seed "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." CARAWAY 0.05 g/mL "Non-Standardized Plant Allergen
ic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histam
tary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed St
orage Proteins [Chemical/Ingredient]"
ON DRUG Mexican Tea Mexican Tea "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." CHENOPODIUM AMBROSIOIDES POLLEN 0.05 g/mL "Non-Sta
49288-0154_3af4be6b-c022-4834-9006-f6cc8d8041da 49288-0154 HUMAN PRESCRIPTI
ON DRUG Cotton Linters Cotton Linters "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." COTTON FIBER 0.05 g/mL "Non-Standardized Plant
ON DRUG Cumin Cumin "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." CUMIN 0.05 g/mL "Non-Standardized Plant Allergenic Extract [EPC]
l/Ingredient]"
ON DRUG Yellow Sweet Clover Yellow Sweet Clover "INJECTION, SOLU
3 "Antigen Laboratories, Inc." MELILOTUS OFFICINALIS POLLEN 0.05
ON DRUG White Sweet Clover White Sweet Clover "INJECTION, SOLU
3 "Antigen Laboratories, Inc." MELILOTUS ALBUS POLLEN 0.05 g/mL
ON DRUG Cladosporium herbarum Cladosporium herbarum "INJECTION, SOLU
3 "Antigen Laboratories, Inc." CLADOSPORIUM HERBARUM 0.1 g/mL
ON DRUG Cladosporium herbarum Cladosporium herbarum "INJECTION, SOLU
3 "Antigen Laboratories, Inc." CLADOSPORIUM HERBARUM 0.05 g/mL
49288-0160_993fabf7-14f0-4417-9838-d1a609628cb5 49288-0160 HUMAN PRESCRIPTI
ON DRUG Cricket Cricket "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." ACHETA DOMESTICUS 0.05 g/mL "Non-Standardized Insect Allerge
ncreased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Ch
emical/Ingredient]"
ON DRUG Date Date "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." DATE 0.05 g/mL "Non-Standardized Food Allergenic Extract [EPC],
hemical/Ingredient],Plant Proteins [Chemical/Ingredient],Fruit Proteins [Chemica
l/Ingredient]"
ON DRUG Dill Seed Dill Seed "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." DILL 0.05 g/mL "Non-Standardized Plant Allergen
tary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Ad
ditives [Chemical/Ingredient]"
ON DRUG Duck Meat Duck Meat "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." DUCK 0.05 g/mL "Non-Standardized Food Allergeni
ergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Poultry Prot
eins [Chemical/Ingredient]"
ON DRUG Dog Hair Dog Hair "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." CANIS LUPUS FAMILIARIS HAIR 0.1 g/mL "Non-Sta
ndardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],
Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredie
ON DRUG Duck Feather Duck Feather "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." ANAS PLATYRHYNCHOS FEATHER 0.05 g/mL "Non-Sta
-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingre
dient]"
ON DRUG Deer Hair Deer Hair "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." ODOCOILEUS VIRGINIANUS HAIR 0.05 g/mL
ON DRUG Dandelion Dandelion "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." TARAXACUM OFFICINALE POLLEN 0.05 g/mL "Non-Sta
ON DRUG Yellow Dock Yellow Dock "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." RUMEX CRISPUS POLLEN 0.05 g/mL "Non-Standardize
49288-0171_a1f5af98-9952-4103-a728-433b94a14e0a 49288-0171 HUMAN PRESCRIPTI
ON DRUG Grain Mill Dust Grain Mill Dust "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." GRAIN MILL DUST 0.02 g/mL
49288-0172_745162a9-2fdc-4b03-a3bc-32d410b3d9c1 49288-0172 HUMAN PRESCRIPTI
ON DRUG "Standardized Mite, Dermatophagoides pteronyssinus" "Standar
dized Mite, Dermatophagoides pteronyssinus" "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." DERMATOPHAGOIDES PTERONYSSINUS 10000 [AU]/mL "Standar
edient]"
edient]"
edient]"
ON DRUG "Standardized Mite, Dermatophagoides farinae" "Standardized Mi
te, Dermatophagoides farinae" "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." DERMATOPHAGOIDES FARINAE 10000 [AU]/mL "Standardized Insect All
ON DRUG Sheep Sorrel Sheep Sorrel "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." RUMEX ACETOSELLA POLLEN 0.1 g/mL "Non-Standardize
ON DRUG Sheep Sorrel Sheep Sorrel "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." RUMEX ACETOSELLA POLLEN 0.05 g/mL "Non-Standardize
49288-0180_89b69938-05fc-4bd8-9c55-4fb46e9018c7 49288-0180 HUMAN PRESCRIPTI
ON DRUG A. Dust House Dust "INJECTION, SOLUTION" INTRADERMAL; SUB
ories, Inc." HOUSE DUST 0.1 g/mL "Non-Standardized House Dust All
mical/Ingredient]"
ON DRUG A. Dust House Dust "INJECTION, SOLUTION" INTRADERMAL; SUB
ories, Inc." HOUSE DUST 0.05 g/mL "Non-Standardized House Dust All
mical/Ingredient]"
ON DRUG Mixture of Standardized Mites Mixture of Standardized Mites
"INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOUS 19911022
BLA BLA102225 "Antigen Laboratories, Inc." DERMATOPHAGOIDES FARINAE
; DERMATOPHAGOIDES PTERONYSSINUS 5000; 5000 [AU]/mL; [AU]/mL
cal/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine
Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens
, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],A
ON DRUG Dock/Sorrel Mixture Dock/Sorrel Mixture "INJECTION, SOLU
3 "Antigen Laboratories, Inc." RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS P
OLLEN .025; .025 g/mL; g/mL "Non-Standardized Pollen Allergenic Extr
],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],I
ncreased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Re
lease [PE],Allergens [Chemical/Ingredient]"
ON DRUG Elm Mixture Elm Mixture "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." ULMUS AMERICANA POLLEN; ULMUS PUMILA POLLEN .025; .0
25 g/mL; g/mL "Non-Standardized Pollen Allergenic Extract [EPC],Increa
ON DRUG Elm Mixture Elm Mixture "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." ULMUS AMERICANA POLLEN; ULMUS PUMILA POLLEN .01; .01
g/mL; g/mL "Non-Standardized Pollen Allergenic Extract [EPC],Increased Hist
emical/Ingredient]"
ON DRUG Epicoccum Epicoccum "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." EPICOCCUM NIGRUM 0.1 g/mL "Increased IgG P
ON DRUG Epicoccum Epicoccum "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." EPICOCCUM NIGRUM 0.05 g/mL "Increased IgG P
ON DRUG Egg White Egg White "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." EGG WHITE 0.05 g/mL "Cell-mediated Immunity
[PE],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release
[PE],Allergens [Chemical/Ingredient],Egg Proteins, Dietary [Chemical/Ingredient]
,Dietary Proteins [Chemical/Ingredient]"
ON DRUG Whole Egg Whole Egg "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." EGG 0.05 g/mL "Non-Standardized Food Allergeni
ergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Egg Proteins
, Dietary [Chemical/Ingredient]"
ON DRUG American Elm American Elm "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." ULMUS AMERICANA POLLEN 0.1 g/mL "Non-Standardize
ON DRUG American Elm American Elm "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." ULMUS AMERICANA POLLEN 0.05 g/mL "Non-Standardize
ON DRUG Chinese (Siberian) Elm Chinese (Siberian) Elm "INJECTION, SOLU
3 "Antigen Laboratories, Inc." ULMUS PUMILA POLLEN 0.05 g/mL
ON DRUG Eucalyptus Eucalyptus "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." EUCALYPTUS GLOBULUS POLLEN 0.05 g/mL "Non-Sta
ON DRUG Epidermophyton Epidermophyton "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." EPIDERMOPHYTON FLOCCOSUM 0.05 g/mL "Non-Sta
ON DRUG Cedar Elm Cedar Elm "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." ULMUS CRASSIFOLIA POLLEN 0.05 g/mL "Non-Sta
ON DRUG Eggplant Eggplant "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." EGGPLANT 0.05 g/mL "Non-Standardized Food A
ON DRUG Fusarium oxysporum Fusarium oxysporum "INJECTION, SOLU
3 "Antigen Laboratories, Inc." FUSARIUM OXYSPORUM 0.1 g/mL
ON DRUG Fusarium oxysporum Fusarium oxysporum "INJECTION, SOLU
3 "Antigen Laboratories, Inc." FUSARIUM OXYSPORUM 0.05 g/mL
ON DRUG Filbert Nut Meat Filbert Nut Meat "INJECTION, SOLU
3 "Antigen Laboratories, Inc." HAZELNUT 0.05 g/mL "Non-Sta
Ingredient],Nut Proteins [Chemical/Ingredient]"
ALLERGENIC Flounder Flounder "INJECTION, SOLUTION"
INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223
"Antigen Laboratories, Inc." FLOUNDER 0.05 g/mL "Non-Standardize
nt],Fish Proteins, Dietary [Chemical/Ingredient]"
ON DRUG Flaxseed Flaxseed "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." FLAX SEED 0.05 g/mL "Non-Standardized Food A
E],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant
Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient]"
ON DRUG Franseria Mixture Franseria Mixture "INJECTION, SOLU
3 "Antigen Laboratories, Inc." AMBROSIA ACANTHICARPA POLLEN; AMBROSIA C
ONFERTIFLORA POLLEN; AMBROSIA DELTOIDEA POLLEN; AMBROSIA DUMOSA POLLEN .0125; .
0125; .0125; .0125 g/mL; g/mL; g/mL; g/mL "Non-Standardized Pollen Allerge
nic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],P
ollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pol
len Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immu
nity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Stand
ardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-me
diated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient
ON DRUG False Ragweed False Ragweed "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." AMBROSIA ACANTHICARPA POLLEN 0.1 g/mL "Non-Sta
nt]"
ON DRUG False Ragweed False Ragweed "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." AMBROSIA ACANTHICARPA POLLEN 0.05 g/mL "Non-Sta
nt]"
ON DRUG Standardized Meadow Fescue Grass Pollen Standardized Meadow Fesc
ue Grass Pollen "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOUS 19970613
BLA BLA102227 "Antigen Laboratories, Inc." FESTUCA PRATENSIS POLLEN
ON DRUG Feather Mixture Feather Mixture "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; GALLUS
GALLUS FEATHER .0333; .0333; .0333 g/mL; g/mL; g/mL "Non-Standardize
ON DRUG Feather Mixture Feather Mixture "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; GALLUS
GALLUS FEATHER .0167; .0167; .0167 g/mL; g/mL; g/mL "Non-Standardize
ON DRUG Rabbit Bush Rabbit Bush "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." AMBROSIA DELTOIDEA POLLEN 0.05 g/mL "Non-Sta
nt]"
ON DRUG Dog Fennel Dog Fennel "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." EUPATORIUM CAPILLIFOLIUM POLLEN 0.05 g/mL "Non-Sta
ON DRUG Number Four Mold Mixture Number Four Mold Mixture
BLA BLA102223 "Antigen Laboratories, Inc." ALTERNARIA ALTERNATA; AS
PERGILLUS FLAVUS; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILL
US REPENS; CLADOSPORIUM CLADOSPORIOIDES; PENICILLIUM CAMEMBERTI; PENICILLIUM CHR
YSOGENUM VAR. CHRYSOGENUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM
EXPANSUM; PENICILLIUM ITALICUM; PENICILLIUM ROQUEFORTI .0125; .0031; .0031; .00
31; .0031; .0125; .0021; .0021; .0021; .0021; .0021; .0021 g/mL; g/mL; g/mL
; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Non-Standardized Fungal
gens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Incr
eased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemic
al/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergeni
c Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fun
ns [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal
n [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non
-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],C
ell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemic
reased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chem
ical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Hist
ON DRUG Grain Smut Mixture Grain Smut Mixture "INJECTION, SOLU
3 "Antigen Laboratories, Inc." USTILAGO AVENAE; USTILAGO MAYDIS; USTILA
GO NUDA HORDEI; USTILAGO TRITICI .025; .025; .025; .025 g/mL; g/mL; g/mL
; g/mL "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Re
GO NUDA HORDEI; USTILAGO TRITICI .0125; .0125; .0125; .0125 g/mL; g/
mL; g/mL; g/mL "Non-Standardized Fungal Allergenic Extract [EPC],Increased Hist
GO NUDA HORDEI; USTILAGO TRITICI .005; .005; .005; .005 g/mL; g/mL; g/mL
; g/mL "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Re
ON DRUG Grass Smut Mixture Grass Smut Mixture "INJECTION, SOLU
TION" SUBCUTANEOUS 19920413 BLA BLA102223 "Antigen
Laboratories, Inc." SPORISORIUM CRUENTUM; USTILAGO CYNODONTIS .05; .05
g/mL; g/mL "Non-Standardized Fungal Allergenic Extract [EPC],Increased Hist
25 g/mL; g/mL "Non-Standardized Fungal Allergenic Extract [EPC],Increa
ON DRUG Gliocladium Gliocladium "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." MYROTHECIUM VERRUCARIA 0.05 g/mL "Non-Standardize
ON DRUG Garlic Garlic "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." GARLIC 0.05 g/mL "Non-Standardized Food Allergenic Extract [EPC],
redient]"
ON DRUG Ginger Ginger "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." GINGER 0.05 g/mL "Non-Standardized Plant Allergenic Extract [EPC]
l/Ingredient]"
ON DRUG Goose Meat Goose Meat "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." GOOSE 0.05 g/mL
ON DRUG Concord Grape Concord Grape "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." CONCORD GRAPE 0.05 g/mL "Non-Standardized Food A
ON DRUG Grapefruit Grapefruit "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." GRAPEFRUIT 1 mL/mL "Non-Standardized Food A
ON DRUG Grapefruit Grapefruit "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." GRAPEFRUIT 0.05 g/mL "Non-Standardized Food A
ON DRUG Goat Hair Goat Hair "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." CAPRA HIRCUS HAIR 0.05 g/mL "Non-Standardize
d Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-med
iated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Alle
ON DRUG Goose Feather Goose Feather "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." ANSER ANSER FEATHER 0.05 g/mL "Non-Standardize
d Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
ON DRUG Sweet Gum Sweet Gum "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." LIQUIDAMBAR STYRACIFLUA POLLEN 0.05 g/mL "Non-Sta
ON DRUG Goldenrod Goldenrod "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." SOLIDAGO CANADENSIS POLLEN 0.05 g/mL "Non-Sta
ON DRUG Geotrichum candidum Geotrichum candidum "INJECTION, SOLU
3 "Antigen Laboratories, Inc." GEOTRICHUM CANDIDUM 0.05 g/mL
ON DRUG Guinea Pig Hair Guinea Pig Hair "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." CAVIA PORCELLUS HAIR 0.1 g/mL "Non-Standardize
iated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient
],Fur [Chemical/Ingredient]"
ON DRUG Guinea Pig Hair Guinea Pig Hair "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." CAVIA PORCELLUS HAIR 0.05 g/mL "Non-Standardize
iated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient
],Fur [Chemical/Ingredient]"
ON DRUG White Grape White Grape "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." WINE GRAPE 0.05 g/mL "Non-Standardized Food A
ON DRUG Mixture of Four Standardized Grasses Mixture of Four Standard
ized Grasses "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOUS 19970613
BLA BLA103421 "Antigen Laboratories, Inc." AGROSTIS GIGANTEA POLLEN
; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN
25000; 25000; 25000; 25000 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL "Standar
lergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Incre
[PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized
Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC]
,Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Prod
uction [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standar
ON DRUG Mixture of Five Standardized Grasses Mixture of Five Standard
ized Grasses "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOUS 19970613
; ANTHOXANTHUM ODORATUM POLLEN; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLE
N; POA PRATENSIS POLLEN 20000; 20000; 20000; 20000; 20000 [BAU]/mL; [BAU]/
mL; [BAU]/mL; [BAU]/mL; [BAU]/mL "Standardized Pollen Allergenic Extract
Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],St
t],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],
Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE
],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ing
redient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract
ON DRUG Mixture of Six Standardized Grasses Mixture of Six Standardi
zed Grasses "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOUS 19970613
; DACTYLIS GLOMERATA POLLEN; FESTUCA PRATENSIS POLLEN; LOLIUM PERENNE POLLEN; PH
LEUM PRATENSE POLLEN; POA PRATENSIS POLLEN 16667; 16667; 16667; 16667; 1666
7; 16667 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL
ient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EP
oduction [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Stand
ardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extra
IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient]
,Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],C
diated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],
ON DRUG Mixture of Seven Standardized Grasses Mixture of Seven Standar
dized Grasses "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOUS 19970613
; ANTHOXANTHUM ODORATUM POLLEN; DACTYLIS GLOMERATA POLLEN; FESTUCA PRATENSIS POL
LEN; LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN
14286; 14286; 14286; 14286; 14286; 14286; 14286 [BAU]/mL; [BAU]/mL; [BAU]/mL; [B
AU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL "Standardized Pollen Allergenic Extract
ction [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standard
ON DRUG Mixture of Eight Standardized Grasses Mixture of Eight Standar
dized Grasses "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOUS 19970613
; ANTHOXANTHUM ODORATUM POLLEN; CYNODON DACTYLON POLLEN; DACTYLIS GLOMERATA POLL
EN; FESTUCA PRATENSIS POLLEN; LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLEN; POA
PRATENSIS POLLEN 12500; 12500; 1250; 12500; 12500; 12500; 12500; 12500
[BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL
Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non
-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],C
Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Inc
on [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardize
ON DRUG Number Fourteen Grass Mixture Number Fourteen Grass Mixture
BLA BLA102223 "Antigen Laboratories, Inc." ARRHENATHERUM ELATIUS PO
LLEN; BROMUS INERMIS POLLEN; BROMUS SECALINUS POLLEN; ELYMUS REPENS POLLEN; HOLC
US LANATUS POLLEN; PASCOPYRUM SMITHII POLLEN; PHALARIS ARUNDINACEA POLLEN; POA C
OMPRESSA POLLEN; SECALE CEREALE POLLEN; SORGHUM BICOLOR SSP. DRUMMONDII POLLEN;
SORGHUM HALEPENSE POLLEN; TRITICUM AESTIVUM POLLEN; TYPHA LATIFOLIA POLLEN; ZEA
MAYS POLLEN .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .
0036; .0036; .0036; .0036; .0036 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL
; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Non-Standardized Pollen Allerge
Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen All
l/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histami
ne Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen
mine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Poll
en [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen
Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Po
[Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased
Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient]
,Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC
t],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [E
roduction [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
ON DRUG Mixture of Standardized and Non-Standardized Southern Grasses
Mixture of Standardized and Non-Standardized Southern Grasses "INJECTION, SOLU
6 "Antigen Laboratories, Inc." AGROSTIS GIGANTEA POLLEN; CYNODON DACTYL
ON POLLEN; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN; POA PRATENSIS POLL
EN; SORGHUM HALEPENSE POLLEN 16667; 1667; 16667; 16667; 16667; .0083 [BAU]/mL
; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL "Standardized Pollen Allergenic
ient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [
ngredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extrac
gG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],
Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Ce
ll-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredi
ent],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC
nt]"
ON DRUG Mixture of Twenty-Two Standardized and Non-Standardized Grasses
Mixture of Twenty-Two Standardized and Non-Standardized Grasses "INJECTION, SOLU
6 "Antigen Laboratories, Inc." AGROSTIS GIGANTEA POLLEN; ANTHOXANTHUM O
DORATUM POLLEN; ARRHENATHERUM ELATIUS POLLEN; BROMUS INERMIS POLLEN; BROMUS SECA
LINUS POLLEN; CYNODON DACTYLON POLLEN; DACTYLIS GLOMERATA POLLEN; ELYMUS REPENS
POLLEN; FESTUCA PRATENSIS POLLEN; HOLCUS LANATUS POLLEN; LOLIUM PERENNE POLLEN;
PASCOPYRUM SMITHII POLLEN; PHALARIS ARUNDINACEA POLLEN; PHLEUM PRATENSE POLLEN;
POA COMPRESSA POLLEN; POA PRATENSIS POLLEN; SECALE CEREALE POLLEN; SORGHUM BICOL
OR SSP. DRUMMONDII POLLEN; SORGHUM HALEPENSE POLLEN; TRITICUM AESTIVUM POLLEN; T
YPHA LATIFOLIA POLLEN; ZEA MAYS POLLEN 4545; 4545; .00227; .00227; .00227; 455;
4545; .00227; 4545; .00227; 4545; .00227; .00227; 4545; .00227; 4545; .00227; .
00227; .00227; .00227; .00227; .00227 [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; [B
AU]/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; [B
AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Standardized Pollen Allergenic
Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic
roduction [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-
ent],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract
Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],No
n-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],
Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingre
dient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extrac
redient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extr
ased IgG Production [PE]"
ON DRUG Mixture of Standardized and Non-Standardized Inland Grasses
Mixture of Standardized and Non-Standardized Inland Grasses "INJECTION, SOLU
1 "Antigen Laboratories, Inc." AGROSTIS GIGANTEA POLLEN; BROMUS INERMIS
POLLEN; DACTYLIS GLOMERATA POLLEN; LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLE
N; POA COMPRESSA POLLEN; POA PRATENSIS POLLEN 14286; .0071; 14286; 14286; 1428
6; .0071; 14286 [BAU]/mL; g/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL; [BAU]/mL
Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non
Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non
ON DRUG Mixture of Standardized and Non-Standardized Coastal Grasses
Mixture of Standardized and Non-Standardized Coastal Grasses "INJECTION, SOLU
1 "Antigen Laboratories, Inc." AGROSTIS GIGANTEA POLLEN; ANTHOXANTHUM O
DORATUM POLLEN; ARRHENATHERUM ELATIUS POLLEN; DACTYLIS GLOMERATA POLLEN; HOLCUS
LANATUS POLLEN; LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLEN; POA COMPRESSA POL
LEN; POA PRATENSIS POLLEN 11111; 11111; .0056; 11111; .0056; 11111; 11111;
.0056; 11111 [BAU]/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; [BAU]/mL; [BAU]/mL; g/
mL; [BAU]/mL "Standardized Pollen Allergenic Extract [EPC],Increased Histamin
[Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allerg
ngredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Rele
ase [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemi
cal/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic E
xtract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamin
cal/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergen
ic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],In
creased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ing
redient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Re
ON DRUG Mixture of Standardized and Non-Standardized Southeastern Grasses
Mixture of Standardized and Non-Standardized Southeastern Grasses "INJECTI
ON, SOLUTION" INTRADERMAL; SUBCUTANEOUS 19970613 BLA
BLA102226 "Antigen Laboratories, Inc." CYNODON DACTYLON POLLEN; PASPALU
M NOTATUM POLLEN; PHLEUM PRATENSE POLLEN 3333; .0167; 33333 [BAU]/mL
; g/mL; [BAU]/mL "Standardized Pollen Allergenic Extract [EPC],Increased
,Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Polle
ON DRUG Hormodendrum Hormodendrum "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." CLADOSPORIUM CLADOSPORIOIDES 0.1 g/mL "Non-Sta
ON DRUG Helminthosporium Helminthosporium "INJECTION, SOLU
3 "Antigen Laboratories, Inc." COCHLIOBOLUS SATIVUS 0.1 g/mL
ALLERGENIC Haddock Haddock "INJECTION, SOLUTION" INTRADERMAL; SUB
ories, Inc." HADDOCK 0.05 g/mL "Non-Standardized Food Allergenic Extrac
ALLERGENIC Halibut Halibut "INJECTION, SOLUTION" INTRADERMAL; SUB
ories, Inc." PACIFIC HALIBUT 0.05 g/mL "Non-Standardized Food Allergeni
ALLERGENIC Halibut Halibut "INJECTION, SOLUTION" INTRADERMAL; SUB
ories, Inc." PACIFIC HALIBUT 0.02 g/mL "Non-Standardized Food Allergeni
ALLERGENIC Herring Herring "INJECTION, SOLUTION" INTRADERMAL; SUB
ories, Inc." HERRING 0.05 g/mL "Non-Standardized Food Allergenic Extrac
ON DRUG Hops Hops "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." HOPS 0.05 g/mL "Non-Standardized Food Allergenic Extract [EPC],
l/Ingredient]"
ON DRUG Horse Hair Horse Hair "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." EQUUS CABALLUS HAIR 0.1 g/mL "Non-Standardize
ON DRUG Hog Hair Hog Hair "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." SUS SCROFA HAIR 0.1 g/mL "Non-Standardized Animal
munity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [C
ON DRUG Hog Hair Hog Hair "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." SUS SCROFA HAIR 0.05 g/mL "Non-Standardized Animal
ON DRUG Hackberry Hackberry "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." CELTIS OCCIDENTALIS POLLEN 0.05 g/mL "Non-Sta
ON DRUG Hazelnut Pollen Hazelnut Pollen "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." CORYLUS AMERICANA POLLEN 0.05 g/mL "Non-Sta
ON DRUG Hickory Pollen Mixture Hickory Pollen Mixture "INJECTION, SOLU
3 "Antigen Laboratories, Inc." CARYA ALBA POLLEN; CARYA CORDIFORMIS POL
LEN; CARYA GLABRA POLLEN; CARYA OVATA POLLEN .0125; .0125; .0125; .0125
g/mL; g/mL; g/mL; g/mL "Non-Standardized Pollen Allergenic Extract [EPC],Increa
ON DRUG Shagbark Hickory Shagbark Hickory "INJECTION, SOLU
3 "Antigen Laboratories, Inc." CARYA OVATA POLLEN 0.05 g/mL
ON DRUG White Hickory White Hickory "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." CARYA ALBA POLLEN 0.1 g/mL "Non-Standardize
ON DRUG White Hickory White Hickory "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." CARYA ALBA POLLEN 0.05 g/mL "Non-Standardize
ON DRUG Hickory/Pecan Mixture Hickory/Pecan Mixture "INJECTION, SOLU
3 "Antigen Laboratories, Inc." CARYA ALBA POLLEN; CARYA ILLINOINENSIS P
ON DRUG Marsh Elder Mixture Marsh Elder Mixture "INJECTION, SOLU
3 "Antigen Laboratories, Inc." IVA ANNUA VAR. ANNUA POLLEN; IVA XANTHIF
OLIA POLLEN .025; .025 g/mL; g/mL "Non-Standardized Pollen Allerge
ON DRUG Marsh Elder Mixture Marsh Elder Mixture "INJECTION, SOLU
3 "Antigen Laboratories, Inc." IVA ANNUA VAR. ANNUA POLLEN; IVA XANTHIF
OLIA POLLEN .01; .01 g/mL; g/mL "Non-Standardized Pollen Allerge
ON DRUG Burweed Marsh Elder Burweed Marsh Elder "INJECTION, SOLU
3 "Antigen Laboratories, Inc." IVA XANTHIFOLIA POLLEN 0.05 g/mL
ON DRUG Rough Marsh Elder Rough Marsh Elder "INJECTION, SOLU
3 "Antigen Laboratories, Inc." IVA ANNUA VAR. ANNUA POLLEN 0.1
ON DRUG Rough Marsh Elder Rough Marsh Elder "INJECTION, SOLU
3 "Antigen Laboratories, Inc." IVA ANNUA VAR. ANNUA POLLEN 0.05
ON DRUG Jute Jute "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." CORCORUS CAPSULARIS FIBER 0.05 g/mL "Non-Standardized Plant
ON DRUG Oneseed Juniper Oneseed Juniper "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." JUNIPERUS MONOSPERMA POLLEN 0.05 g/mL "Non-Sta
ON DRUG Utah Juniper Utah Juniper "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." JUNIPERUS OSTEOSPERMA POLLEN 0.05 g/mL "Non-Sta
ON DRUG Johnson Grass Pollen Johnson Grass Pollen "INJECTION, SOLU
3 "Antigen Laboratories, Inc." SORGHUM HALEPENSE POLLEN 0.1
ON DRUG Johnson Grass Pollen Johnson Grass Pollen "INJECTION, SOLU
3 "Antigen Laboratories, Inc." SORGHUM HALEPENSE POLLEN 0.05
ON DRUG Standardized Kentucky (June) Bluegrass Standardized Kentucky (J
une) Bluegrass "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOUS 19970613
BLA BLA103421 "Antigen Laboratories, Inc." POA PRATENSIS POLLEN
ON DRUG Johnson Grass Smut Johnson Grass Smut "INJECTION, SOLU
3 "Antigen Laboratories, Inc." SPORISORIUM CRUENTUM 0.1 g/mL
ON DRUG Western (Sierra) Juniper Western (Sierra) Juniper
BLA BLA102223 "Antigen Laboratories, Inc." JUNIPERUS OCCIDENTALIS P
OLLEN 0.05 g/mL "Non-Standardized Pollen Allergenic Extract [EPC],Increa
ON DRUG Kochia Kochia "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." KOCHIA SCOPARIA POLLEN 0.1 g/mL "Non-Standardized Pollen Allerge
gredient]"
gredient]"
gredient]"
ON DRUG Kapok Kapok "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." CEIBA PENTANDRA FIBER 0.05 g/mL "Non-Standardized Plant Fiber Al
ON DRUG Lettuce Lettuce "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." LETTUCE 0.05 g/mL "Non-Standardized Food Allergenic Extract [EPC],
/Ingredient]"
ON DRUG Lamb Lamb "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." LAMB 0.05 g/mL "Non-Standardized Food Allergenic Extract [EPC],
edient]"
ON DRUG Lemon Lemon "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." LEMON 1 mL/mL "Non-Standardized Food Allergenic Extract [EPC],
redient]"
ON DRUG Lime Lime "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." LIME (CITRUS) 1 mL/mL "Non-Standardized Food Allergenic Extrac
ical/Ingredient]"
ON DRUG Lentil Lentil "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." LENTIL 0.05 g/mL "Non-Standardized Food Allergenic Extract [EPC],
ALLERGENIC Lobster Lobster "INJECTION, SOLUTION" INTRADERMAL; SUB
ories, Inc." LOBSTER 0.05 g/mL "Non-Standardized Food Allergenic Extrac
ON DRUG Malt Malt "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." "MALT EXTRACT, BARLEY" 0.05 g/mL "Non-Standardized Food Allergeni
tary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Grain P
roteins [Chemical/Ingredient]"
ON DRUG Monilia Mixture Monilia Mixture "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." CANDIDA TROPICALIS; NEUROSPORA INTERMEDIA .025; .0
25 g/mL; g/mL "Non-Standardized Fungal Allergenic Extract [EPC],Increa
ON DRUG Mucor Mixture Mucor Mixture "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." MUCOR PLUMBEUS; MUCOR RACEMOSUS; RHIZOPUS STOLONIFER
.0333; .0333; .0333 g/mL; g/mL; g/mL "Non-Standardized Fungal Allerge
ON DRUG Mucor Mixture Mucor Mixture "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." MUCOR PLUMBEUS; MUCOR RACEMOSUS; RHIZOPUS STOLONIFER
.0167; .0167; .0167 g/mL; g/mL; g/mL "Non-Standardized Fungal Allerge
ON DRUG Mycogone perniciosa Mycogone perniciosa "INJECTION, SOLU
3 "Antigen Laboratories, Inc." HYPOMYCES PERNICIOSUS 0.1 g/mL
ON DRUG Mycogone perniciosa Mycogone perniciosa "INJECTION, SOLU
3 "Antigen Laboratories, Inc." HYPOMYCES PERNICIOSUS 0.05 g/mL
ON DRUG Microsporum audouinii Microsporum audouinii "INJECTION, SOLU
3 "Antigen Laboratories, Inc." MICROSPORUM AUDOUINII 0.05 g/mL
ON DRUG Microsporum canis Microsporum canis "INJECTION, SOLU
3 "Antigen Laboratories, Inc." MICROSPORUM CANIS 0.05 g/mL
ON DRUG Honeydew Melon Honeydew Melon "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." HONEYDEW MELON 0.05 g/mL "Non-Standardized Food A
ON DRUG Cow Milk Cow Milk "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." COW MILK 0.05 g/mL "Non-Standardized Food A
ON DRUG Goat Milk Goat Milk "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." GOAT MILK 0.05 g/mL "Non-Standardized Food A
ON DRUG Millet Millet "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." MILLET SEED 0.05 g/mL
ON DRUG Mint Mint "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." SPEARMINT 0.05 g/mL "Non-Standardized Food Allergenic Extrac
t [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Food Additi
ves [Chemical/Ingredient],Allergens [Chemical/Ingredient],Dietary Proteins [Chem
ical/Ingredient]"
ON DRUG Mushroom Mushroom "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." CULTIVATED MUSHROOM 0.05 g/mL "Non-Standardize
nt],Fungal Proteins [Chemical/Ingredient]"
ON DRUG Mustard Seed Mustard Seed "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." MUSTARD SEED 0.05 g/mL "Non-Standardized Plant
E],Allergens [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Dietary
Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage
ON DRUG Coastal Maple Coastal Maple "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." ACER MACROPHYLLUM POLLEN 0.05 g/mL "Increas
[PE],Cell-mediated Immunity [PE]"
ON DRUG Maple Pollen Mixture Maple Pollen Mixture "INJECTION, SOLU
3 "Antigen Laboratories, Inc." ACER RUBRUM POLLEN; ACER SACCHARINUM POL
LEN; ACER SACCHARUM POLLEN .0167; .0167; .0167 g/mL; g/mL; g/mL
t],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release
[PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/
ON DRUG Maple Pollen Mixture Maple Pollen Mixture "INJECTION, SOLU
LEN; ACER SACCHARUM POLLEN .0067; .0067; .0067 g/mL; g/mL; g/mL
ON DRUG Mesquite Mesquite "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." PROSOPIS JULIFLORA POLLEN 0.05 g/mL "Non-Sta
ON DRUG Mulberry Mixture Mulberry Mixture "INJECTION, SOLU
3 "Antigen Laboratories, Inc." BROUSSONETIA PAPYRIFERA POLLEN; MORUS AL
BA POLLEN; MORUS RUBRA POLLEN .0167; .0167; .0167 g/mL; g/mL; g/mL
ON DRUG Candida albicans Candida albicans "INJECTION, SOLU
3 "Antigen Laboratories, Inc." CANDIDA ALBICANS 0.1 g/mL
ON DRUG Mattress Dust Mattress Dust "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." HOUSE DUST 0.05 g/mL "Non-Standardized House
Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Imm
unity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House D
ust [Chemical/Ingredient]"
ON DRUG Mustard Greens Mustard Greens "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." MUSTARD GREENS 0.05 g/mL "Non-Standardized Food A
ent],Plant Proteins [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient]
ON DRUG Melaleuca Melaleuca "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." MELALEUCA QUINQUENERVIA POLLEN 0.05 g/mL "Non-Sta
ON DRUG Mucor racemosus Mucor racemosus "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." MUCOR RACEMOSUS 0.1 g/mL "Non-Standardized Fungal
ON DRUG Mucor racemosus Mucor racemosus "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." MUCOR RACEMOSUS 0.05 g/mL "Non-Standardized Fungal
ON DRUG Candida tropicalis Candida tropicalis "INJECTION, SOLU
3 "Antigen Laboratories, Inc." CANDIDA TROPICALIS 0.05 g/mL
ON DRUG Hard (Sugar) Maple Hard (Sugar) Maple "INJECTION, SOLU
3 "Antigen Laboratories, Inc." ACER SACCHARUM POLLEN 0.05 g/mL
ON DRUG Red Maple Red Maple "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." ACER RUBRUM POLLEN 0.05 g/mL "Non-Standardize
ON DRUG Soft (Silver) Maple Soft (Silver) Maple "INJECTION, SOLU
3 "Antigen Laboratories, Inc." ACER SACCHARINUM POLLEN 0.05 g/mL
ON DRUG Red Mulberry Red Mulberry "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." MORUS RUBRA POLLEN 0.05 g/mL "Non-Standardize
ON DRUG White Mulberry White Mulberry "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." MORUS ALBA POLLEN 0.05 g/mL "Non-Standardize
ON DRUG Neurospora intermedia Neurospora intermedia "INJECTION, SOLU
3 "Antigen Laboratories, Inc." NEUROSPORA INTERMEDIA 0.05 g/mL
ON DRUG Nigrospora Nigrospora "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." KHUSKIA ORYZAE 0.1 g/mL "Non-Standardized Fungal
ON DRUG Nigrospora Nigrospora "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." KHUSKIA ORYZAE 0.05 g/mL "Non-Standardized Fungal
ON DRUG Nutmeg Nutmeg "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." NUTMEG 0.05 g/mL "Non-Standardized Food Allergenic Extract [EPC],
,Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Plant Proteins [Che
mical/Ingredient],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemica
l/Ingredient],Seed Storage Proteins [Chemical/Ingredient]"
ON DRUG Nettle Pollen Nettle Pollen "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." URTICA DIOICA POLLEN 0.05 g/mL "Non-Standardize
ON DRUG Oak Mixture Oak Mixture "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." QUERCUS ALBA POLLEN; QUERCUS MACROCARPA POLLEN; QUERCUS
MUEHLENBERGII POLLEN; QUERCUS PALUSTRIS POLLEN; QUERCUS RUBRA POLLEN; QUERCUS ST
ELLATA POLLEN; QUERCUS VELUTINA POLLEN; QUERCUS VIRGINIANA POLLEN .0063; .
0063; .0063; .0063; .0063; .0063; .0063; .0063 g/mL; g/mL; g/mL; g/mL; g/mL; g/
mL; g/mL; g/mL "Non-Standardized Pollen Allergenic Extract [EPC],Increased Hist
nity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [
Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased
,Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized P
[Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increase
E],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized
Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated
Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allerge
ON DRUG Oak Mixture Oak Mixture "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." QUERCUS ALBA POLLEN; QUERCUS MACROCARPA POLLEN; QUERCUS
MUEHLENBERGII POLLEN; QUERCUS PALUSTRIS POLLEN; QUERCUS RUBRA POLLEN; QUERCUS ST
ELLATA POLLEN; QUERCUS VELUTINA POLLEN; QUERCUS VIRGINIANA POLLEN .0025; .
ON DRUG Orange Orange "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." ORANGE 1 mL/mL "Non-Standardized Food Allergenic Extract [EPC],
redient]"
ON DRUG Whole Grain Oat Whole Grain Oat "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." OAT 0.05 g/mL "Non-Standardized Food Allergeni
ON DRUG Onion Onion "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." ONION 0.05 g/mL "Non-Standardized Food Allergenic Extract [EPC],
/Ingredient]"
ALLERGENIC Oyster Oyster "INJECTION, SOLUTION" INTRADERMAL; SUB
ories, Inc." OYSTER 0.05 g/mL "Non-Standardized Food Allergenic Extrac
ON DRUG California (Coastal) Live Oak California (Coastal) Live Oak
BLA BLA102223 "Antigen Laboratories, Inc." QUERCUS AGRIFOLIA POLLEN
ON DRUG Olive Pollen Olive Pollen "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." OLEA EUROPAEA POLLEN 0.05 g/mL "Non-Standardize
ON DRUG Tall Oat Grass Tall Oat Grass "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." ARRHENATHERUM ELATIUS POLLEN 0.05 g/mL "Non-Sta
nt]"
ON DRUG Standardized Orchard Grass Pollen Standardized Orchard Gra
BLA BLA102228 "Antigen Laboratories, Inc." DACTYLIS GLOMERATA POLLE
N 100000 [BAU]/mL "Standardized Pollen Allergenic Extract [EPC],In
ON DRUG Oat Smut Oat Smut "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." USTILAGO AVENAE 0.05 g/mL "Non-Standardized Fungal
ON DRUG Orris Root Orris Root "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." IRIS GERMANICA VAR. FLORENTINA ROOT 0.1 g/mL
"Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Prod
uction [PE],Allergens [Chemical/Ingredient],Non-Standardized Plant Allergenic Ex
tract [EPC],Plant Proteins [Chemical/Ingredient]"
ON DRUG Orris Root Orris Root "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." IRIS GERMANICA VAR. FLORENTINA ROOT 0.05 g/mL
"Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Prod
uction [PE],Allergens [Chemical/Ingredient],Non-Standardized Plant Allergenic Ex
tract [EPC],Plant Proteins [Chemical/Ingredient]"
ON DRUG Olive Olive "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." GREEN OLIVE 0.05 g/mL "Non-Standardized Food Allergenic Extrac
t [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Rele
ase [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Plant Prote
ins [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins
ON DRUG Cultivated Oat Pollen Cultivated Oat Pollen "INJECTION, SOLU
3 "Antigen Laboratories, Inc." AVENA SATIVA POLLEN 0.05 g/mL
ON DRUG Orange Pollen Orange Pollen "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." CITRUS SINENSIS POLLEN 0.05 g/mL "Non-Standardize
ON DRUG Live Oak Live Oak "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." QUERCUS VIRGINIANA POLLEN 0.1 g/mL "Non-Sta
ON DRUG Live Oak Live Oak "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." QUERCUS VIRGINIANA POLLEN 0.05 g/mL "Non-Sta
ON DRUG White Oak White Oak "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." QUERCUS ALBA POLLEN 0.1 g/mL "Non-Standardize
ON DRUG White Oak White Oak "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." QUERCUS ALBA POLLEN 0.05 g/mL "Non-Standardize
ON DRUG Bur Oak Bur Oak "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." QUERCUS MACROCARPA POLLEN 0.05 g/mL "Non-Standardized Pollen
mical/Ingredient]"
ON DRUG Pin Oak Pin Oak "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." QUERCUS PALUSTRIS POLLEN 0.05 g/mL "Non-Standardized Pollen
mical/Ingredient]"
ON DRUG Russian Olive Russian Olive "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." ELAEAGNUS ANGUSTIFOLIA POLLEN 0.05 g/mL "Non-Sta
ON DRUG Garrys Oak Garrys Oak "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." QUERCUS GARRYANA POLLEN 0.05 g/mL "Non-Standardize
ON DRUG Gambel Oak Gambel Oak "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." QUERCUS GAMBELII POLLEN 0.05 g/mL "Non-Standardize
ON DRUG Number Three Oak Mixture Number Three Oak Mixture
BLA BLA102223 "Antigen Laboratories, Inc." QUERCUS ALBA POLLEN; QUE
RCUS RUBRA POLLEN; QUERCUS VIRGINIANA POLLEN .0167; .0167; .0167 g/mL; g/
ON DRUG Pigweed Mixture Pigweed Mixture "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN
; AMARANTHUS SPINOSUS POLLEN; AMARANTHUS TUBERCULATUS POLLEN .0125; .0125; .0
125; .0125 g/mL; g/mL; g/mL; g/mL "Non-Standardized Pollen Allergenic Extr
act [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [C
hemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Alle
rgenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE
],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized
Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated I
mmunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-St
-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredi
ent],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Releas
e [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemica
l/Ingredient],Allergens [Chemical/Ingredient]"
ON DRUG Pigweed Mixture Pigweed Mixture "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN
; AMARANTHUS SPINOSUS POLLEN; AMARANTHUS TUBERCULATUS POLLEN .005; .005; .005
; .005 g/mL; g/mL; g/mL; g/mL "Non-Standardized Pollen Allergenic Extract [EPC
d Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non
ON DRUG English Plantain English Plantain "INJECTION, SOLU
3 "Antigen Laboratories, Inc." PLANTAGO LANCEOLATA POLLEN 0.1
ON DRUG Penicillium Mixture Penicillium Mixture "INJECTION, SOLU
3 "Antigen Laboratories, Inc." PENICILLIUM CAMEMBERTI; PENICILLIUM CHRY
SOGENUM VAR. CHRYSOGENUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM
67; .0167; .0167 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Non-Standardize
ON DRUG Penicillium Mixture Penicillium Mixture "INJECTION, SOLU
3 "Antigen Laboratories, Inc." PENICILLIUM CAMEMBERTI; PENICILLIUM CHRY
SOGENUM VAR. CHRYSOGENUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM
83; .0083; .0083 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Non-Standardize
ON DRUG Phoma Phoma "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." PHOMA DESTRUCTIVA 0.1 g/mL "Non-Standardized Fungal Allerge
emical/Ingredient]"
ON DRUG Phoma Phoma "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." PHOMA DESTRUCTIVA 0.05 g/mL "Non-Standardized Fungal Allerge
emical/Ingredient]"
ON DRUG Pullularia Pullularia "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." AUREOBASIDIUM PULLULANS VAR. PULLUTANS 0.1 g/mL
ON DRUG Paecilomyces Paecilomyces "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." PAECILOMYCES VARIOTII 0.1 g/mL "Non-Standardize
ON DRUG Paecilomyces Paecilomyces "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." PAECILOMYCES VARIOTII 0.05 g/mL "Non-Standardize
ON DRUG Papularia Papularia "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." APIOSPORA MONTAGNEI 0.05 g/mL "Non-Standardize
ent]"
ON DRUG Phycomyces Phycomyces "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." PHYCOMYCES BLAKESLEEANUS 0.05 g/mL "Non-Sta
ON DRUG Potato Potato "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." POTATO 0.05 g/mL "Non-Standardized Food Allergenic Extract [EPC],
/Ingredient]"
ON DRUG Pork Pork "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." PORK 0.05 g/mL "Non-Standardized Food Allergenic Extract [EPC],
edient]"
ON DRUG Paprika Paprika "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." PAPRIKA 0.05 g/mL "Non-Standardized Food Allergenic Extract [EPC],
/Ingredient],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ing
redient]"
ON DRUG Parsley Parsley "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." PARSLEY 0.05 g/mL "Non-Standardized Food Allergenic Extract [EPC],
/Ingredient]"
ON DRUG Peach Peach "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." PEACH 1 mL/mL "Non-Standardized Food Allergenic Extract [EPC],
redient]"
ON DRUG Peanut Peanut "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." PEANUT 0.05 g/mL "Non-Standardized Food Allergenic Extract [EPC],
dient]"
ON DRUG Green Pea Green Pea "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." PEA 0.05 g/mL "Non-Standardized Food Allergeni
ON DRUG Black-eyed Pea Black-eyed Pea "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." BLACK-EYED PEA 0.05 g/mL "Non-Standardized Food A
[PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient]"
ON DRUG Pear Pear "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." PEAR 0.05 g/mL "Non-Standardized Food Allergenic Extract [EPC],
redient]"
ON DRUG Pecan Nut Meat Pecan Nut Meat "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." PECAN 0.05 g/mL "Non-Standardized Food Allergeni
ergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins
ON DRUG Black Pepper Black Pepper "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." BLACK PEPPER 0.05 g/mL "Non-Standardized Food A
ON DRUG Red Pepper Red Pepper "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." RED BELL PEPPER 0.05 g/mL "Non-Standardized Food A
ON DRUG Green Bell Pepper Green Bell Pepper "INJECTION, SOLU
3 "Antigen Laboratories, Inc." GREEN BELL PEPPER 0.05 g/mL
"Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE]
hemical/Ingredient],Vegetable Proteins [Chemical/Ingredient]"
ALLERGENIC Perch Perch "INJECTION, SOLUTION" INTRADERMAL; SUB
ories, Inc." PERCH 0.05 g/mL "Non-Standardized Food Allergenic Extrac
ON DRUG Sweet Potato Sweet Potato "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." SWEET POTATO 0.05 g/mL "Non-Standardized Food A
ON DRUG Pumpkin Pumpkin "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." PUMPKIN 1 mL/mL "Non-Standardized Food Allergenic Extract [EPC],
/Ingredient]"
49288-0390_1d474d27-4ce9-4bf6-b468-4a92281edc72 49288-0390 HUMAN PRESCRIPTI
ON DRUG Parakeet Feather Parakeet Feather "INJECTION, SOLU
3 "Antigen Laboratories, Inc." MELOPSITTACUS UNDULATUS FEATHER 0.02
g/mL "Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine R
elease [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [
Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Al
PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chem
ical/Ingredient]"
ON DRUG Pecan Pollen Pecan Pollen "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." CARYA ILLINOINENSIS POLLEN 0.1 g/mL "Non-Sta
ON DRUG Ponderosa Pine Ponderosa Pine "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." PINUS PONDEROSA POLLEN 0.05 g/mL "Non-Standardize
ON DRUG Poplar Mixture Poplar Mixture "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." POPULUS ALBA POLLEN; POPULUS NIGRA POLLEN .025; .0
25 g/mL; g/mL "Non-Standardized Pollen Allergenic Extract [EPC],Increa
ON DRUG Privet Privet "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." LIGUSTRUM VULGARE POLLEN 0.05 g/mL "Non-Standardized Pollen
mical/Ingredient]"
ON DRUG Privet Privet "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." LIGUSTRUM VULGARE POLLEN 0.02 g/mL "Non-Standardized Pollen
mical/Ingredient]"
ON DRUG Pepper Tree Pepper Tree "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." SCHINUS MOLLE POLLEN 0.05 g/mL "Non-Standardize
ON DRUG Queen Palm Queen Palm "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." SYAGRUS ROMANZOFFIANA POLLEN 0.05 g/mL "Non-Sta
ON DRUG Number Three Pine Mixture Number Three Pine Mixture
BLA BLA102223 "Antigen Laboratories, Inc." PINUS ECHINATA POLLEN; P
INUS PONDEROSA POLLEN; PINUS TAEDA POLLEN .0167; .0167; .0167 g/mL; g/
ON DRUG Pyrethrum Pyrethrum "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." PYRETHRUM CINERARIIFOLIUM 0.05 g/mL "Non-Sta
ndardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-m
ON DRUG Pimento Pimento "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." RED BELL PEPPER 0.05 g/mL "Non-Standardized Food Allergenic Extrac
ON DRUG Pineapple Pineapple "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." PINEAPPLE 0.05 g/mL "Non-Standardized Food A
ON DRUG Plum Plum "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." PLUM 1 mL/mL "Non-Standardized Food Allergenic Extract [EPC],
redient]"
ON DRUG Plum Plum "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." PLUM 0.05 g/mL "Non-Standardized Food Allergenic Extract [EPC],
redient]"
ON DRUG Rough (Redroot) Pigweed Rough (Redroot) Pigweed "INJECTION, SOLU
3 "Antigen Laboratories, Inc." AMARANTHUS RETROFLEXUS POLLEN 0.1
ON DRUG Rough (Redroot) Pigweed Rough (Redroot) Pigweed "INJECTION, SOLU
3 "Antigen Laboratories, Inc." AMARANTHUS RETROFLEXUS POLLEN 0.05
ON DRUG Eastern White Pine Eastern White Pine "INJECTION, SOLU
3 "Antigen Laboratories, Inc." PINUS STROBUS POLLEN 0.1 g/mL
ON DRUG Eastern White Pine Eastern White Pine "INJECTION, SOLU
3 "Antigen Laboratories, Inc." PINUS STROBUS POLLEN 0.05 g/mL
ON DRUG Australian Pine Australian Pine "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." CASUARINA EQUISETIFOLIA POLLEN 0.1 g/mL "Non-Sta
ON DRUG Australian Pine Australian Pine "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." CASUARINA EQUISETIFOLIA POLLEN 0.05 g/mL "Non-Sta
ON DRUG Spiny Pigweed Spiny Pigweed "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." AMARANTHUS SPINOSUS POLLEN 0.05 g/mL "Non-Sta
nt]"
ON DRUG Slash Pine Slash Pine "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." PINUS ELLIOTTII POLLEN 0.05 g/mL "Non-Standardize
ON DRUG Penicillium notatum Penicillium notatum "INJECTION, SOLU
3 "Antigen Laboratories, Inc." PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM
ON DRUG Penicillium notatum Penicillium notatum "INJECTION, SOLU
ON DRUG White Poplar White Poplar "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." POPULUS ALBA POLLEN 0.05 g/mL "Non-Standardize
ON DRUG Lombardy Poplar Lombardy Poplar "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." POPULUS NIGRA POLLEN 0.05 g/mL "Non-Standardize
ON DRUG Lodgepole Pine Lodgepole Pine "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." PINUS CONTORTA POLLEN 0.05 g/mL "Non-Standardize
ON DRUG Scotch Pine Scotch Pine "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." PINUS SYLVESTRIS POLLEN 0.05 g/mL "Non-Standardize
ON DRUG Loblolly Pine Loblolly Pine "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." PINUS TAEDA POLLEN 0.05 g/mL "Non-Standardize
ON DRUG Pitch Pine Pitch Pine "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." PINUS RIGIDA POLLEN 0.05 g/mL "Non-Standardize
ON DRUG Shortleaf Pine Shortleaf Pine "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." PINUS ECHINATA POLLEN 0.05 g/mL "Non-Standardize
ON DRUG Poverty Weed Poverty Weed "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." IVA AXILLARIS POLLEN 0.05 g/mL "Non-Standardize
ON DRUG Cayenne Pepper Cayenne Pepper "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." CHILI PEPPER 0.05 g/mL "Non-Standardized Plant
ON DRUG Number Two Pine Mixture Number Two Pine Mixture "INJECTION, SOLU
3 "Antigen Laboratories, Inc." PINUS CONTORTA POLLEN; PINUS PONDEROSA P
nt]"
ON DRUG Bakers Yeast Bakers Yeast "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." SACCHAROMYCES CEREVISIAE 0.05 g/mL "Non-Sta
ent],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Ex
tract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine R
elease [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],A
llergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient]"
ON DRUG Quack Grass Quack Grass "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." ELYMUS REPENS POLLEN 0.05 g/mL "Non-Standardize
ON DRUG Ragweed Mixture Ragweed Mixture "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA BIDENTATA POLLE
N; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN .0125; .0125; .0
],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Poll
istamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],A
ON DRUG Russian Thistle Russian Thistle "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." SALSOLA KALI POLLEN 0.1 g/mL "Non-Standardize
ON DRUG Russian Thistle Russian Thistle "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." SALSOLA KALI POLLEN 0.05 g/mL "Non-Standardize
ON DRUG Rhizopus Rhizopus "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." RHIZOPUS STOLONIFER 0.1 g/mL "Non-Standardize
ON DRUG Rhizopus Rhizopus "INJECTION, SOLUTION" INTRADER
ON DRUG Rhodotorula Rhodotorula "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." RHODOTORULA RUBRA 0.05 g/mL "Non-Standardize
ON DRUG Rabbit Meat Rabbit Meat "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." RABBIT 0.05 g/mL "Non-Standardized Food Allergeni
ergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Protein
ON DRUG Radish Radish "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." RAPHANUS SATIVUS 0.05 g/mL
ON DRUG Raspberry Raspberry "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." RASPBERRY 1 mL/mL "Non-Standardized Food A
ON DRUG Raspberry Raspberry "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." RASPBERRY 0.05 g/mL "Non-Standardized Food A
ON DRUG Rice Rice "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." RICE 0.05 g/mL "Non-Standardized Food Allergenic Extract [EPC],
redient]"
ON DRUG Rye Rye "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." RYE 0.05 g/mL "Non-Standardized Food Allergenic Extract [EPC],
redient]"
ON DRUG Rabbit Hair Rabbit Hair "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." ORYCTOLAGUS CUNICULUS HAIR 0.1 g/mL "Non-Sta
nt],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ing
redient]"
ON DRUG Rabbit Hair Rabbit Hair "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." ORYCTOLAGUS CUNICULUS HAIR 0.05 g/mL "Non-Sta
nt],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ing
redient]"
ON DRUG Redwood Pollen Redwood Pollen "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." SEQUOIA SEMPERVIRENS POLLEN 0.05 g/mL "Non-Sta
ON DRUG Slender Ragweed Slender Ragweed "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." AMBROSIA CONFERTIFLORA POLLEN 0.05 g/mL "Non-Sta
ON DRUG Giant Ragweed Giant Ragweed "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." AMBROSIA TRIFIDA POLLEN 0.05 g/mL "Non-Standardize
49288-0448_3a632396-c97c-4b7f-8eef-8908cf591385 49288-0448 HUMAN PRESCRIPTI
ON DRUG Standardized Short Ragweed Pollen Standardized Short Ragwe
ed Pollen "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOUS 19830115
BLA BLA102232 "Antigen Laboratories, Inc." AMBROSIA ARTEMISIIFOLIA
POLLEN 100000 [AU]/mL "Standardized Pollen Allergenic Extract [EPC],Increased
ON DRUG Southern Ragweed Southern Ragweed "INJECTION, SOLU
3 "Antigen Laboratories, Inc." AMBROSIA BIDENTATA POLLEN 0.05
ON DRUG Western Ragweed Western Ragweed "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." AMBROSIA PSILOSTACHYA POLLEN 0.05 g/mL "Non-Sta
nt]"
ON DRUG Standardized Redtop Grass Pollen Standardized Redtop Gras
s Pollen "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOUS 19970613
100000 [BAU]/mL "Standardized Pollen Allergenic Extract [EPC],Non-Standa
ON DRUG Standardized Perennial Rye Grass Pollen Standardized Perennial R
ye Grass Pollen "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOUS 19970613
BLA BLA102230 "Antigen Laboratories, Inc." LOLIUM PERENNE POLLEN
ON DRUG Cultivated Rye Grass Cultivated Rye Grass "INJECTION, SOLU
3 "Antigen Laboratories, Inc." SECALE CEREALE POLLEN 0.05 g/mL
ON DRUG Short/Giant Ragweed Mixture Short/Giant Ragweed Mixture
POLLEN; AMBROSIA TRIFIDA POLLEN .025; .025 g/mL; g/mL "Non-Standardize
Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Stan
dardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-m
ediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient]
ON DRUG Desert Ragweed Desert Ragweed "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." AMBROSIA DUMOSA POLLEN 0.05 g/mL "Non-Standardize
ON DRUG Short/Giant/Western Ragweed Mixture Short/Giant/Western Ragw
eed Mixture "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOUS 19740323
POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN .0167; .0167; .0
167 g/mL; g/mL; g/mL "Non-Standardized Pollen Allergenic Extract [EPC
Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extra
,Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [P
Ingredient]"
ON DRUG Sage Mixture Sage Mixture "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." ARTEMISIA ABSINTHIUM POLLEN; ARTEMISIA LUDOVICIANA POLLE
N; ARTEMISIA TRIDENTATA POLLEN; ARTEMISIA VULGARIS POLLEN .0125; .0125; .0
ent]"
ON DRUG Sage Mixture Sage Mixture "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." ARTEMISIA ABSINTHIUM POLLEN; ARTEMISIA LUDOVICIANA POLLE
N; ARTEMISIA TRIDENTATA POLLEN; ARTEMISIA VULGARIS POLLEN .005; .005; .005
; .005 g/mL; g/mL; g/mL; g/mL "Non-Standardized Pollen Allergenic Extract [EPC
d Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
ON DRUG Sorrel Mixture Sorrel Mixture "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." RUMEX ACETOSELLA POLLEN; RUMEX ALTISSIMUS POLLEN; RUMEX
CRISPUS POLLEN; RUMEX OBTUSIFOLIUS POLLEN; RUMEX SALICIFOLIUS VAR. MEXICANUS POL
LEN .01; .01; .01; .01; .01 g/mL; g/mL; g/mL; g/mL; g/mL "Non-Standardize
ens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-
],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardi
on [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standar
ON DRUG Sorrel Mixture Sorrel Mixture "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." RUMEX ACETOSELLA POLLEN; RUMEX ALTISSIMUS POLLEN; RUMEX
CRISPUS POLLEN; RUMEX OBTUSIFOLIUS POLLEN; RUMEX SALICIFOLIUS VAR. MEXICANUS POL
LEN .004; .004; .004; .004; .004 g/mL; g/mL; g/mL; g/mL; g/mL "Non-Sta
C],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/In
gredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-S
49288-0461_f1a31511-6642-4da5-82cf-67c9ca728bc6 49288-0461 HUMAN PRESCRIPTI
ON DRUG Miller Moth Miller Moth "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." SITOTROGA CEREALELLA 0.05 g/mL
ON DRUG Saccharomyces Saccharomyces "INJECTION, SOLUTION" INTRADER
ON DRUG Scopulariopsis Scopulariopsis "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." MICROASCUS BREVICAULIS 0.05 g/mL "Non-Standardize
ON DRUG Spondylocladium Spondylocladium "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." COLLETOTRICHUM COCCODES 0.1 g/mL "Non-Standardize
ON DRUG Spondylocladium Spondylocladium "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." COLLETOTRICHUM COCCODES 0.05 g/mL "Non-Standardize
ON DRUG Stemphylium Stemphylium "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." PLEOSPORA HERBARUM 0.1 g/mL "Non-Standardize
ON DRUG Stemphylium Stemphylium "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." PLEOSPORA HERBARUM 0.05 g/mL "Non-Standardize
ON DRUG Streptomyces Streptomyces "INJECTION, SOLUTION" INTRADER
MAL; SUBCONJUNCTIVAL 19740323 BLA BLA102223 "Antigen
Laboratories, Inc." STREPTOMYCES GRISEUS 0.05 g/mL "Non-Standardize
d Bacterial Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-media
ted Immunity [PE],Increased IgG Production [PE],Bacterial Proteins [Chemical/Ing
ON DRUG Sporotrichum Sporotrichum "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." SPOROTRICHUM PRUINOSUM 0.05 g/mL "Non-Standardize
ON DRUG Stachybotrys Stachybotrys "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." STACHYBOTRYS CHARTARUM 0.1 g/mL "Non-Standardize
ON DRUG Stachybotrys Stachybotrys "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." STACHYBOTRYS CHARTARUM 0.05 g/mL "Non-Standardize
ON DRUG Syncephalastrum Syncephalastrum "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." SYNCEPHALASTRUM RACEMOSUM 0.05 g/mL "Non-Sta
49288-0473_38eb8027-2cc3-42f8-ad39-70588a8bd791 49288-0473 HUMAN PRESCRIPTI
ON DRUG Sole Sole "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." ENGLISH SOLE 0.05 g/mL "Non-Standardized Food Allergenic Extrac
ON DRUG Safflower Seed Safflower Seed "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." SAFFLOWER 0.05 g/mL
ON DRUG Sesame Seed Sesame Seed "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." SESAME SEED 0.05 g/mL "Non-Standardized Food A
ALLERGENIC Salmon Salmon "INJECTION, SOLUTION" INTRADERMAL; SUB
ories, Inc." ATLANTIC SALMON 0.05 g/mL "Non-Standardized Food Allergeni
ALLERGENIC Sardine Sardine "INJECTION, SOLUTION" INTRADERMAL; SUB
ories, Inc." EUROPEAN PILCHARD 0.05 g/mL "Non-Standardized Food A
ALLERGENIC Shrimp Shrimp "INJECTION, SOLUTION" INTRADERMAL; SUB
ories, Inc." SHRIMP 0.05 g/mL "Non-Standardized Food Allergenic Extrac
ON DRUG Spinach Spinach "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." SPINACH 0.05 g/mL "Non-Standardized Food Allergenic Extract [EPC],
/Ingredient]"
ON DRUG Strawberry Strawberry "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." STRAWBERRY 1 mL/mL "Non-Standardized Food A
ON DRUG Sugar Beet Sugar Beet "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." BEET 0.05 g/mL "Non-Standardized Plant Allergen
tary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetab
le Proteins [Chemical/Ingredient]"
ON DRUG Sugar Cane Sugar Cane "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." SUGARCANE 0.05 g/mL
ON DRUG Sunflower Seed Sunflower Seed "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." SUNFLOWER SEED 0.05 g/mL "Non-Standardized Food A
ON DRUG Annual Saltbush Annual Saltbush "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." ATRIPLEX WRIGHTII POLLEN 0.05 g/mL "Non-Sta
ON DRUG American Sycamore American Sycamore "INJECTION, SOLU
3 "Antigen Laboratories, Inc." PLATANUS OCCIDENTALIS POLLEN 0.1
ON DRUG American Sycamore American Sycamore "INJECTION, SOLU
3 "Antigen Laboratories, Inc." PLATANUS OCCIDENTALIS POLLEN 0.05
ON DRUG California Sycamore California Sycamore "INJECTION, SOLU
3 "Antigen Laboratories, Inc." PLATANUS RACEMOSA POLLEN 0.05
ON DRUG Maple Leaf Sycamore Maple Leaf Sycamore "INJECTION, SOLU
3 "Antigen Laboratories, Inc." PLATANUS HYBRIDA POLLEN 0.05 g/mL
ON DRUG Coastal Sage Coastal Sage "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." ARTEMISIA CALIFORNICA POLLEN 0.05 g/mL "Non-Sta
nt]"
ON DRUG Sunflower Pollen Sunflower Pollen "INJECTION, SOLU
3 "Antigen Laboratories, Inc." HELIANTHUS ANNUUS POLLEN 0.05
ON DRUG Sudan Grass Sudan Grass "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." SORGHUM BICOLOR SSP. DRUMMONDII POLLEN 0.05 g/mL
ON DRUG Standardized Sweet Vernal Grass Pollen Standardized Sweet Verna
l Grass Pollen "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOUS 19970613
BLA BLA103624 "Antigen Laboratories, Inc." ANTHOXANTHUM ODORATUM PO
LLEN 100000 [BAU]/mL "Standardized Pollen Allergenic Extract [EPC],In
ON DRUG Sage Sage "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." SALVIA OFFICINALIS 0.05 g/mL "Non-Standardized Plant Allergen
tary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient]"
ON DRUG Saltgrass Saltgrass "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." DISTICHLIS SPICATA POLLEN 0.05 g/mL "Non-Sta
ON DRUG Common Mugwort Sage Common Mugwort Sage "INJECTION, SOLU
3 "Antigen Laboratories, Inc." ARTEMISIA VULGARIS POLLEN 0.05
ON DRUG Desert Sage Desert Sage "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." ARTEMISIA TRIDENTATA POLLEN 0.1 g/mL "Non-Sta
nt]"
ON DRUG Desert Sage Desert Sage "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." ARTEMISIA TRIDENTATA POLLEN 0.05 g/mL "Non-Sta
nt]"
ON DRUG Common Wormwood Sage Common Wormwood Sage "INJECTION, SOLU
3 "Antigen Laboratories, Inc." ARTEMISIA ABSINTHIUM POLLEN 0.05
ON DRUG Western Mugwort Sage Western Mugwort Sage "INJECTION, SOLU
3 "Antigen Laboratories, Inc." ARTEMISIA LUDOVICIANA POLLEN 0.05
ON DRUG Tree Mixture Tree Mixture "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." ACER NEGUNDO POLLEN; ACER RUBRUM POLLEN; ACER SACCHARINU
M POLLEN; ACER SACCHARUM POLLEN; AILANTHUS ALTISSIMA POLLEN; BETULA PAPYRIFERA P
OLLEN; CARPINUS CAROLINIANA POLLEN; CARYA ALBA POLLEN; CARYA OVATA POLLEN; CELTI
S OCCIDENTALIS POLLEN; FAGUS GRANDIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; JUGL
ANS NIGRA POLLEN; JUNIPERUS ASHEI POLLEN; JUNIPERUS PINCHOTII POLLEN; JUNIPERUS
VIRGINIANA POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; MORUS ALBA POLLEN; MORUS RUBR
A POLLEN; PICEA PUNGENS POLLEN; PINUS STROBUS POLLEN; PLATANUS OCCIDENTALIS POLL
EN; POPULUS ALBA POLLEN; SALIX NIGRA POLLEN .0021; .0021; .0021; .0021; .002
1; .0021; .0021; .0021; .0021; .0021; .0021; .0021; .0021; .0021; .0021; .0021;
.0021; .0021; .0021; .0021; .0021; .0021; .0021; .0021 g/mL; g/mL; g/mL; g/mL;
g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/
mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Non-Standardized Pollen Allergenic Extr
ient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Relea
se [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemic
al/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergeni
reased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingr
edient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Rel
ease [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chem
ical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allerge
Pollen [Chemical/Ingredient]"
ON DRUG Tree Mixture Tree Mixture "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." ACER NEGUNDO POLLEN; ACER RUBRUM POLLEN; ACER SACCHARINU
M POLLEN; ACER SACCHARUM POLLEN; AILANTHUS ALTISSIMA POLLEN; BETULA PAPYRIFERA P
OLLEN; CARPINUS CAROLINIANA POLLEN; CARYA ALBA POLLEN; CARYA OVATA POLLEN; CELTI
S OCCIDENTALIS POLLEN; FAGUS GRANDIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; JUGL
ANS NIGRA POLLEN; JUNIPERUS ASHEI POLLEN; JUNIPERUS PINCHOTII POLLEN; JUNIPERUS
VIRGINIANA POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; MORUS ALBA POLLEN; MORUS RUBR
A POLLEN; PICEA PUNGENS POLLEN; PINUS STROBUS POLLEN; PLATANUS OCCIDENTALIS POLL
EN; POPULUS ALBA POLLEN; SALIX NIGRA POLLEN .0008; .0008; .0008; .0008; .000
8; .0008; .0008; .0008; .0008; .0008; .0008; .0008; .0008; .0008; .0008; .0008;
.0008; .0008; .0008; .0008; .0008; .0008; .0008; .0008 g/mL; g/mL; g/mL; g/mL;
mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Non-Standardized Pollen Allergenic Extr
Pollen [Chemical/Ingredient]"
ON DRUG Trichoderma Trichoderma "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." TRICHODERMA VIRIDE 0.1 g/mL "Non-Standardize
ON DRUG Trichoderma Trichoderma "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." TRICHODERMA VIRIDE 0.05 g/mL "Non-Standardize
ON DRUG Tetracoccosporium paxianum Tetracoccosporium paxianum
BLA BLA102223 "Antigen Laboratories, Inc." TETRACOCCOSPORIUM PAXIAN
UM 0.05 g/mL "Non-Standardized Fungal Allergenic Extract [EPC],Increa
ON DRUG Tomato Tomato "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." TOMATO 0.05 g/mL "Non-Standardized Food Allergenic Extract [EPC],
/Ingredient]"
ON DRUG Tapioca Tapioca "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." "STARCH, TAPIOCA" 0.05 g/mL
ON DRUG Tea Tea "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." TEA LEAF 0.05 g/mL "Non-Standardized Plant Allergenic Extra
teins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient]"
ALLERGENIC Trout Trout "INJECTION, SOLUTION" INTRADERMAL; SUB
ories, Inc." TROUT 0.05 g/mL "Non-Standardized Food Allergenic Extrac
ALLERGENIC Tuna Tuna "INJECTION, SOLUTION" INTRADERMAL; SUB
ories, Inc." TUNA 0.05 g/mL "Non-Standardized Food Allergenic Extrac
ON DRUG Turkey Turkey "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." TURKEY 0.05 g/mL "Non-Standardized Food Allergenic Extract [EPC],
/Ingredient],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Chemical/I
ngredient]"
ON DRUG Turnip Turnip "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." TURNIP 0.05 g/mL "Non-Standardized Plant Allergenic Extract [EPC]
ON DRUG Thyme Thyme "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." GARDEN THYME 0.05 g/mL "Non-Standardized Food Allergenic Extrac
gG Production [PE],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemic
ON DRUG Tamarack Tamarack "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." LARIX OCCIDENTALIS POLLEN 0.05 g/mL "Non-Sta
ON DRUG Tree of Heaven Tree of Heaven "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." AILANTHUS ALTISSIMA POLLEN 0.05 g/mL "Non-Sta
ON DRUG Standardized Timothy Grass Pollen Standardized Timothy Gra
BLA BLA102231 "Antigen Laboratories, Inc." PHLEUM PRATENSE POLLEN
ON DRUG Trichophyton Mixture Trichophyton Mixture "INJECTION, SOLU
3 "Antigen Laboratories, Inc." TRICHOPHYTON MENTAGROPHYTES; TRICHOPHYTO
N RUBRUM .05; .05 g/mL; g/mL "Non-Standardized Fungal Allerge
ungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
ON DRUG Trichophyton rubrum Trichophyton rubrum "INJECTION, SOLU
3 "Antigen Laboratories, Inc." TRICHOPHYTON RUBRUM 0.1 g/mL
ON DRUG Trichophyton rubrum Trichophyton rubrum "INJECTION, SOLU
3 "Antigen Laboratories, Inc." TRICHOPHYTON RUBRUM 0.05 g/mL
ON DRUG Leaf Tobacco Leaf Tobacco "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." TOBACCO LEAF 0.1 g/mL "Non-Standardized Plant
ON DRUG Number Eleven Tree Mixture Number Eleven Tree Mixture
BLA BLA102223 "Antigen Laboratories, Inc." ACER SACCHARUM POLLEN; B
ETULA NIGRA POLLEN; CARYA OVATA POLLEN; FAGUS GRANDIFOLIA POLLEN; FRAXINUS AMERI
CANA POLLEN; JUGLANS NIGRA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOID
ES POLLEN; QUERCUS RUBRA POLLEN; SALIX NIGRA POLLEN; ULMUS AMERICANA POLLEN
.0045; .0045; .0045; .0045; .0045; .0045; .0045; .0045; .0045; .0045; .0045
g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Non-Sta
ient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract
[EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased Ig
G Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],N
on-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE]
,Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingr
edient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extra
ON DRUG Trichophyton mentagrophytes Trichophyton mentagrophytes
BLA BLA102223 "Antigen Laboratories, Inc." TRICHOPHYTON MENTAGROPHY
TES 0.05 g/mL "Non-Standardized Fungal Allergenic Extract [EPC],Increa
ON DRUG Number Ten Mold Mixture Number Ten Mold Mixture "INJECTION, SOLU
3 "Antigen Laboratories, Inc." ALTERNARIA ALTERNATA; ASPERGILLUS FLAVUS
; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS; AUREO
BASIDIUM PULLULANS VAR. PULLUTANS; CLADOSPORIUM CLADOSPORIOIDES; COCHLIOBOLUS SA
TIVUS; FUSARIUM OXYSPORUM; MUCOR RACEMOSUS; PENICILLIUM CAMEMBERTI; PENICILLIUM
CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILL
IUM EXPANSUM; PENICILLIUM ITALICUM; PENICILLIUM ROQUEFORTI; PHOMA DESTRUCTIVA; R
HIZOPUS STOLONIFER .01; .0025; .0025; .0025; .0025; .01; .01; .01; .01; .01
; .0017; .0017; .0017; .0017; .0017; .0017; .01; .01 g/mL; g/mL; g/mL; g/mL;
mL "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Re
ity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],N
,Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Ch
ON DRUG Number Ten Mold Mixture Number Ten Mold Mixture "INJECTION, SOLU
3 "Antigen Laboratories, Inc." ALTERNARIA ALTERNATA; ASPERGILLUS FLAVUS
; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS; AUREO
BASIDIUM PULLULANS VAR. PULLUTANS; CLADOSPORIUM CLADOSPORIOIDES; COCHLIOBOLUS SA
TIVUS; FUSARIUM OXYSPORUM; MUCOR RACEMOSUS; PENICILLIUM CAMEMBERTI; PENICILLIUM
CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILL
IUM EXPANSUM; PENICILLIUM ITALICUM; PENICILLIUM ROQUEFORTI; PHOMA DESTRUCTIVA; R
HIZOPUS STOLONIFER .005; .0013; .0013; .0013; .0013; .005; .005; .005; .005
; .005; .0008; .0008; .0008; .0008; .0008; .0008; .005; .005 g/mL; g/mL; g/mL
; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL;
ed Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingre
ase [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Aller
ON DRUG Washington/Oregon Coastal Tree Mixture Washington/Oregon Coasta
l Tree Mixture "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOUS 19960712
BLA BLA102223 "Antigen Laboratories, Inc." ALNUS RHOMBIFOLIA POLLEN
; BETULA OCCIDENTALIS POLLEN; FRAXINUS LATIFOLIA POLLEN; JUGLANS NIGRA POLLEN; J
UGLANS REGIA POLLEN; PINUS CONTORTA POLLEN; POPULUS BALSAMIFERA SUBSP. TRICHOCAR
PA POLLEN; QUERCUS GARRYANA POLLEN; SALIX LUCIDA SSP. LASIANDRA POLLEN .0056; .
0056; .0056; .0056; .0056; .0056; .0056; .0056; .0056 g/mL; g/mL; g/mL; g/mL;
g/mL; g/mL; g/mL; g/mL; g/mL "Non-Standardized Pollen Allergenic Extract [EPC
]"
ON DRUG Washington/Oregon Inland Tree Mixture Washington/Oregon Inland
Tree Mixture "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOUS 19960712
BLA BLA102223 "Antigen Laboratories, Inc." ACER NEGUNDO POLLEN; ALN
US RHOMBIFOLIA POLLEN; BETULA OCCIDENTALIS POLLEN; FRAXINUS LATIFOLIA POLLEN; PI
NUS CONTORTA POLLEN; PINUS PONDEROSA POLLEN; POPULUS BALSAMIFERA SUBSP. TRICHOCA
RPA POLLEN; POPULUS TREMULOIDES POLLEN; SALIX LUCIDA SSP. LASIANDRA POLLEN
.0056; .0056; .0056; .0056; .0056; .0056; .0056; .0056; .0056 g/mL; g/mL; g/mL
; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Non-Standardized Pollen Allergenic Extr
ON DRUG Number Seven Tree Mixture Number Seven Tree Mixture
BLA BLA102223 "Antigen Laboratories, Inc." ACER RUBRUM POLLEN; ACER
SACCHARINUM POLLEN; ACER SACCHARUM POLLEN; BETULA NIGRA POLLEN; CARYA ILLINOINE
NSIS POLLEN; JUNIPERUS VIRGINIANA; POPULUS ALBA POLLEN; QUERCUS VIRGINIANA POLLE
N; ULMUS AMERICANA POLLEN .0024; .0024; .0024; .0071; .0071; .0071; .0071;
.0071; .0071 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Non-Sta
"
ON DRUG Vanilla Bean Vanilla Bean "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." VANILLA 0.05 g/mL "Non-Standardized Food Allergeni
c Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Foo
d Additives [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Allerge
ON DRUG Venison Venison "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOU
nc." VENISON 0.05 g/mL "Non-Standardized Food Allergenic Extract [EPC],
edient]"
ON DRUG Velvet Grass Velvet Grass "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." HOLCUS LANATUS POLLEN 0.05 g/mL "Non-Standardize
ON DRUG Verticillium Verticillium "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." VERTICILLIUM ALBO-ATRUM 0.05 g/mL "Non-Standardize
ON DRUG Whole Wheat Whole Wheat "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." WHEAT 0.05 g/mL "Non-Standardized Food Allergeni
ON DRUG English Walnut Meat English Walnut Meat "INJECTION, SOLU
3 "Antigen Laboratories, Inc." ENGLISH WALNUT 0.05 g/mL "Non-Sta
ON DRUG Black Walnut Meat Black Walnut Meat "INJECTION, SOLU
3 "Antigen Laboratories, Inc." BLACK WALNUT 0.05 g/mL "Non-Sta
ON DRUG Watermelon Watermelon "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." WATERMELON 0.05 g/mL "Non-Standardized Food A
ALLERGENIC White Fish White Fish "INJECTION, SOLUTION"
INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223
"Antigen Laboratories, Inc." WHITEFISH 0.05 g/mL "Non-Standardize
nt],Fish Proteins, Dietary [Chemical/Ingredient]"
ON DRUG Black Walnut Black Walnut "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." JUGLANS NIGRA POLLEN 0.1 g/mL "Non-Standardize
ON DRUG California Black Walnut California Black Walnut "INJECTION, SOLU
3 "Antigen Laboratories, Inc." JUGLANS CALIFORNICA POLLEN 0.05
g/mL "Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity
[PE],Increased IgG Production [PE],Increased Histamine Release [PE],Pollen [Che
ON DRUG English Walnut Pollen English Walnut Pollen "INJECTION, SOLU
3 "Antigen Laboratories, Inc." JUGLANS REGIA POLLEN 0.05 g/mL
ON DRUG Western Black Willow Western Black Willow "INJECTION, SOLU
3 "Antigen Laboratories, Inc." SALIX LUCIDA SSP. LASIANDRA POLLEN
ON DRUG Wheat Smut Wheat Smut "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." USTILAGO TRITICI 0.05 g/mL "Non-Standardize
ON DRUG Cultivated Wheat Cultivated Wheat "INJECTION, SOLU
3 "Antigen Laboratories, Inc." TRITICUM AESTIVUM POLLEN 0.05
ngredient]"
ON DRUG Pussy Willow Pussy Willow "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." SALIX DISCOLOR POLLEN 0.05 g/mL "Non-Standardize
ON DRUG Black Willow Black Willow "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." SALIX NIGRA POLLEN 0.05 g/mL "Non-Standardize
ON DRUG Number Two Weed Mixture Number Two Weed Mixture "INJECTION, SOLU
3 "Antigen Laboratories, Inc." AMARANTHUS RETROFLEXUS POLLEN; CHENOPODI
UM ALBUM POLLEN; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN; XANTHIUM STRUMAR
IUM POLLEN .01; .01; .01; .01; .01 g/mL; g/mL; g/mL; g/mL; g/mL "Non-Sta
l-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingred
ient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [P
E],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamin
e Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergeni
edient]"
ON DRUG Number Four Weed Mixture Number Four Weed Mixture
BLA BLA102223 "Antigen Laboratories, Inc." AMARANTHUS RETROFLEXUS P
OLLEN; AMARANTHUS TUBERCULATUS POLLEN; ARTEMISIA CALIFORNICA POLLEN; ARTEMISIA D
RACUNCULUS POLLEN; ARTEMISIA FRIGIDA POLLEN; ARTEMISIA TRIDENTATA POLLEN; ARTEMI
SIA VULGARIS POLLEN; CHENOPODIUM ALBUM POLLEN; IVA AXILLARIS POLLEN; KOCHIA SCOP
ARIA POLLEN; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN; SALSOLA KALI POLLEN;
XANTHIUM STRUMARIUM POLLEN .0036; .0036; .0036; .0036; .0036; .0036; .0036;
.0036; .0036; .0036; .0036; .0036; .0036; .0036 g/mL; g/mL; g/mL; g/mL;
g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Non-Standardize
Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-
[EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemi
ic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Po
l/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic
Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen
[Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingre
dient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Rele
ase [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Che
ON DRUG Western Wheatgrass Western Wheatgrass "INJECTION, SOLU
3 "Antigen Laboratories, Inc." PASCOPYRUM SMITHII POLLEN 0.05
ON DRUG Washington/Oregon Coastal Weed Mixture Washington/Oregon Coasta
l Weed Mixture "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOUS 19960711
OLLEN; ARTEMISIA VULGARIS POLLEN; CHENOPODIUM ALBUM POLLEN; PLANTAGO LANCEOLATA
POLLEN; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN; XANTHIUM STRUMARIUM POLLE
N .0071; .0071; .0071; .0071; .0071; .0071; .0071 g/mL; g/mL; g/mL; g/mL;
g/mL; g/mL; g/mL "Non-Standardized Pollen Allergenic Extract [EPC],Increa
d Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non
,Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/In
gredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunit
y [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Hist
amine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Aller
Ingredient]"
ON DRUG Washington/Oregon Inland Weed Mixture Washington/Oregon Inland
Weed Mixture "INJECTION, SOLUTION" INTRADERMAL; SUBCUTANEOUS 19960711
OLLEN; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PS
ILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; ARTEMISIA TRIDENTATA POLLEN; ARTEMIS
IA VULGARIS POLLEN; ATRIPLEX CANESCENS POLLEN; CHENOPODIUM ALBUM POLLEN; IVA XAN
THIFOLIA POLLEN; SALSOLA KALI POLLEN .0045; .0045; .0045; .0045; .0045; .0045
; .0045; .0045; .0045; .0045; .0045 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL
; g/mL; g/mL; g/mL; g/mL "Non-Standardized Pollen Allergenic Extract [EPC
e [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemi
eased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingred
emical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergeni
ease [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Ch
ON DRUG Number Three Weed Mixture Number Three Weed Mixture
OLLEN; CHENOPODIUM ALBUM POLLEN; KOCHIA SCOPARIA POLLEN; RUMEX ACETOSELLA POLLEN
.0125; .0125; .0125; .0125 g/mL; g/mL; g/mL; g/mL "Non-Standardized Pollen
ity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standa
rdized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG
Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],A
ON DRUG Brewers Yeast Brewers Yeast "INJECTION, SOLUTION" INTRADER
ON DRUG Trichophyton schoenleinii Trichophyton schoenleinii
BLA BLA102223 "Antigen Laboratories, Inc." TRICHOPHYTON SCHOENLEINI
I 0.05 g/mL "Non-Standardized Fungal Allergenic Extract [EPC],Increa
ON DRUG Absidia ramosa Absidia ramosa "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." MYCOCLADUS CORYMBIFERUS 0.05 g/mL "Non-Standardize
ON DRUG Acrothecium robustum Acrothecium robustum "INJECTION, SOLU
3 "Antigen Laboratories, Inc." ACROTHECIUM ROBUSTUM 0.05 g/mL
ON DRUG Aspergillus repens Aspergillus repens "INJECTION, SOLU
3 "Antigen Laboratories, Inc." ASPERGILLUS REPENS 0.05 g/mL
ON DRUG Allscale Allscale "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." ATRIPLEX POLYCARPA POLLEN 0.05 g/mL "Non-Sta
ON DRUG Green Ash Green Ash "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." FRAXINUS PENNSYLVANICA POLLEN 0.05 g/mL "Non-Sta
ON DRUG Aspergillus flavus Aspergillus flavus "INJECTION, SOLU
3 "Antigen Laboratories, Inc." ASPERGILLUS FLAVUS 0.05 g/mL
ON DRUG Blue Beech (Hornbeam) Blue Beech (Hornbeam) "INJECTION, SOLU
3 "Antigen Laboratories, Inc." CARPINUS CAROLINIANA POLLEN 0.05
ON DRUG Black Birch Black Birch "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." BETULA LENTA POLLEN 0.05 g/mL "Non-Standardize
ON DRUG Yellow Birch Yellow Birch "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." BETULA ALLEGHANIENSIS POLLEN 0.05 g/mL "Non-Sta
ON DRUG Jerusalem Oak Jerusalem Oak "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." CHENOPODIUM BOTRYS POLLEN 0.05 g/mL "Non-Sta
ON DRUG Tall Dock Tall Dock "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." RUMEX ALTISSIMUS POLLEN 0.05 g/mL "Non-Standardize
ON DRUG Bitter Dock Bitter Dock "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." RUMEX OBTUSIFOLIUS POLLEN 0.05 g/mL "Non-Sta
ON DRUG White (Mexican) Dock White (Mexican) Dock "INJECTION, SOLU
3 "Antigen Laboratories, Inc." RUMEX SALICIFOLIUS VAR. MEXICANUS POLLEN
ON DRUG Pignut Hickory Pignut Hickory "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." CARYA GLABRA POLLEN 0.05 g/mL "Non-Standardize
ON DRUG Bitternut Hickory Bitternut Hickory "INJECTION, SOLU
3 "Antigen Laboratories, Inc." CARYA CORDIFORMIS POLLEN 0.05
ON DRUG Humicola grisea Humicola grisea "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." HUMICOLA GRISEA 0.05 g/mL "Non-Standardized Fungal
ON DRUG Paper Mulberry Paper Mulberry "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." BROUSSONETIA PAPYRIFERA POLLEN 0.05 g/mL "Non-Sta
ON DRUG Mucor mucedo Mucor mucedo "INJECTION, SOLUTION" INTRADER
ON DRUG Mucor plumbeus Mucor plumbeus "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." MUCOR PLUMBEUS 0.05 g/mL "Non-Standardized Fungal
ON DRUG Neurospora crassa Neurospora crassa "INJECTION, SOLU
3 "Antigen Laboratories, Inc." NEUROSPORA CRASSA 0.05 g/mL
ON DRUG Black Oak Black Oak "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." QUERCUS VELUTINA POLLEN 0.05 g/mL "Non-Standardize
ON DRUG Chestnut Oak Chestnut Oak "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." QUERCUS MUEHLENBERGII POLLEN 0.05 g/mL "Non-Sta
ON DRUG Post Oak Post Oak "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." QUERCUS STELLATA POLLEN 0.05 g/mL "Non-Standardize
ON DRUG Jack Pine Pollen Jack Pine Pollen "INJECTION, SOLU
3 "Antigen Laboratories, Inc." PINUS BANKSIANA POLLEN 0.05 g/mL
ON DRUG Red Pine Red Pine "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." PINUS RESINOSA POLLEN 0.05 g/mL "Non-Standardize
ON DRUG Austrian Pine Austrian Pine "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." PINUS NIGRA POLLEN 0.05 g/mL "Non-Standardize
ON DRUG Japanese Black Pine Japanese Black Pine "INJECTION, SOLU
3 "Antigen Laboratories, Inc." PINUS THUNBERGII POLLEN 0.05 g/mL
ON DRUG Penicillium roquefortii Penicillium roquefortii "INJECTION, SOLU
3 "Antigen Laboratories, Inc." PENICILLIUM ROQUEFORTI 0.05 g/mL
ON DRUG Penicillium camembertii Penicillium camembertii "INJECTION, SOLU
3 "Antigen Laboratories, Inc." PENICILLIUM CAMEMBERTI 0.05 g/mL
ON DRUG Penicillium chrysogenum Penicillium chrysogenum "INJECTION, SOLU
ON DRUG Penicillium expansum Penicillium expansum "INJECTION, SOLU
3 "Antigen Laboratories, Inc." PENICILLIUM EXPANSUM 0.05 g/mL
ON DRUG Penicillium italicum Penicillium italicum "INJECTION, SOLU
3 "Antigen Laboratories, Inc." PENICILLIUM ITALICUM 0.05 g/mL
ON DRUG Blue Spruce Blue Spruce "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." PICEA PUNGENS POLLEN 0.05 g/mL "Non-Standardize
ON DRUG Prairie Sage Prairie Sage "INJECTION, SOLUTION" INTRADER
Laboratories, Inc." ARTEMISIA FRIGIDA POLLEN 0.05 g/mL "Non-Sta
nt]"
ON DRUG Indian Wormwood Sage Indian Wormwood Sage "INJECTION, SOLU
3 "Antigen Laboratories, Inc." ARTEMISIA DRACUNCULUS POLLEN 0.05
49288-0655_fb54abb5-85cd-485f-9542-a2742a31bf72 49288-0655 HUMAN PRESCRIPTI
ON DRUG Coca-Glycerine Control Coca-Glycerine Control "INJECTION, SOLU
TION" INTRADERMAL 19740323 BLA BLA102223 "Antigen
Laboratories, Inc." GLYCERIN 0.525 mL/mL "Non-Standardized Chemic
al Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],I
ncreased IgG Production [PE],Allergens [Chemical/Ingredient],Glycerol [Chemical/
Ingredient]"
49288-0656_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0656 HUMAN PRESCRIPTI
ON DRUG Treatment Set TS329678 Treatment Set TS329678 "INJECTION, SOLU
3 "Antigen Laboratories, Inc." AMBROSIA ARTEMISIIFOLIA POLLEN; CARYA AL
BA POLLEN; CYNODON DACTYLON POLLEN; POA PRATENSIS POLLEN; QUERCUS ALBA POLLEN; S
ORGHUM HALEPENSE POLLEN 10000; .005; 1000; 10000; .005; .005 [AU]/mL; g/mL; [
BAU]/mL; [BAU]/mL; g/mL; g/mL "Standardized Pollen Allergenic Extract [EPC],In
ion [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardiz
gens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increase
ns [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increa
3 "Antigen Laboratories, Inc." ACER NEGUNDO POLLEN; ACER RUBRUM POLLEN;
ACER SACCHARINUM POLLEN; ACER SACCHARUM POLLEN; AGROSTIS GIGANTEA POLLEN; AILAN
THUS ALTISSIMA POLLEN; ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA POLLEN; AMB
ROSIA BIDENTATA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; A
NTHOXANTHUM ODORATUM POLLEN; ARRHENATHERUM ELATIUS POLLEN; ASPERGILLUS FLAVUS; A
SPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS; AUREOBAS
IDIUM PULLULANS VAR. PULLUTANS; BETULA PAPYRIFERA POLLEN; BROMUS INERMIS POLLEN;
BROMUS SECALINUS POLLEN; CARPINUS CAROLINIANA POLLEN; CARYA ALBA POLLEN; CARYA
OVATA POLLEN; CELTIS OCCIDENTALIS POLLEN; CLADOSPORIUM CLADOSPORIOIDES; COCHLIOB
OLUS SATIVUS; CYNODON DACTYLON POLLEN; DACTYLIS GLOMERATA POLLEN; DERMATOPHAGOID
ES PTERONYSSINUS; ELYMUS REPENS POLLEN; FAGUS GRANDIFOLIA POLLEN; FESTUCA PRATEN
SIS POLLEN; FRAXINUS AMERICANA POLLEN; FUSARIUM OXYSPORUM; HOLCUS LANATUS POLLEN
; IVA ANNUA VAR. ANNUA POLLEN; IVA XANTHIFOLIA POLLEN; JUGLANS NIGRA POLLEN; JUN
IPERUS ASHEI POLLEN; JUNIPERUS PINCHOTII POLLEN; JUNIPERUS VIRGINIANA POLLEN; LI
QUIDAMBAR STYRACIFLUA POLLEN; LOLIUM PERENNE POLLEN; MORUS ALBA POLLEN; MORUS RU
BRA POLLEN; MUCOR RACEMOSUS; PASCOPYRUM SMITHII POLLEN; PENICILLIUM CAMEMBERTI;
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGEN
UM; PENICILLIUM EXPANSUM; PENICILLIUM ITALICUM; PENICILLIUM ROQUEFORTI; PHALARIS
ARUNDINACEA POLLEN; PHLEUM PRATENSE POLLEN; PHOMA DESTRUCTIVA; PICEA PUNGENS PO
LLEN; PINUS STROBUS POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS PO
LLEN; POA COMPRESSA POLLEN; POA PRATENSIS POLLEN; POPULUS ALBA POLLEN; RHIZOPUS
STOLONIFER; SALIX NIGRA POLLEN; SALSOLA KALI POLLEN; SECALE CEREALE POLLEN; SORG
HUM BICOLOR SSP. DRUMMONDII POLLEN; SORGHUM HALEPENSE POLLEN; TRITICUM AESTIVUM
POLLEN; TYPHA LATIFOLIA POLLEN; ZEA MAYS POLLEN .00021; .00021; .00021; .00021;
454.5; .00021; .001; .00125; .00125; .00125; .00125; 454.5; .000227; .00025; .00
025; .00025; .00025; .001; .00021; .000227; .000227; .00021; .00021; .00021; .00
021; .001; .001; 45.5; 454.5; 1000; .000227; .00021; 454.5; .00021; .001; .00022
7; .0025; .0025; .00021; .00021; .00021; .00021; .00021; 454.5; .00021; .00021;
.001; .000227; .00017; .00017; .00017; .00017; .00017; .00017; .000227; 454.5; .
001; .00021; .00021; .005; .00021; .000227; 454.5; .00021; .001; .00021; .005; .
000227; .000227; .000227; .000227; .000227; .000227 g/mL; g/mL; g/mL; g/mL;
[BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL;
g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU
]/mL; [AU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g
/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL;
g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL;
g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Standardized Insect Allergenic
ased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect
Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-S
tract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen
[Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Al
PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemic
al/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histam
ine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Polle
n [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen
[PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chem
ical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Hist
ACER SACCHARINUM POLLEN; ACER SACCHARUM POLLEN; AGROSTIS GIGANTEA POLLEN; AILAN
THUS ALTISSIMA POLLEN; AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN;
AMARANTHUS SPINOSUS POLLEN; AMARANTHUS TUBERCULATUS POLLEN; AMBROSIA ARTEMISIIF
OLIA POLLEN; AMBROSIA BIDENTATA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA T
RIFIDA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; ARRHENATHERUM ELATIUS POLLEN; ARTEM
ISIA ABSINTHIUM POLLEN; ARTEMISIA LUDOVICIANA POLLEN; ARTEMISIA TRIDENTATA POLLE
N; ARTEMISIA VULGARIS POLLEN; BETULA PAPYRIFERA POLLEN; BROMUS INERMIS POLLEN; B
ROMUS SECALINUS POLLEN; CARPINUS CAROLINIANA POLLEN; CARYA ALBA POLLEN; CARYA OV
ATA POLLEN; CELTIS OCCIDENTALIS POLLEN; CYNODON DACTYLON POLLEN; DACTYLIS GLOMER
ATA POLLEN; ELYMUS REPENS POLLEN; FAGUS GRANDIFOLIA POLLEN; FESTUCA PRATENSIS PO
LLEN; FRAXINUS AMERICANA POLLEN; HOLCUS LANATUS POLLEN; IVA ANNUA VAR. ANNUA POL
LEN; IVA XANTHIFOLIA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS ASHEI POLLEN; JUNIP
ERUS PINCHOTII POLLEN; JUNIPERUS VIRGINIANA POLLEN; KOCHIA SCOPARIA POLLEN; LIQU
IDAMBAR STYRACIFLUA POLLEN; LOLIUM PERENNE POLLEN; MORUS ALBA POLLEN; MORUS RUBR
A POLLEN; PASCOPYRUM SMITHII POLLEN; PHALARIS ARUNDINACEA POLLEN; PHLEUM PRATENS
E POLLEN; PICEA PUNGENS POLLEN; PINUS STROBUS POLLEN; PLATANUS OCCIDENTALIS POLL
EN; POA COMPRESSA POLLEN; POA PRATENSIS POLLEN; POPULUS ALBA POLLEN; RUMEX ACETO
SELLA POLLEN; RUMEX CRISPUS POLLEN; SALIX NIGRA POLLEN; SECALE CEREALE POLLEN; S
ORGHUM BICOLOR SSP. DRUMMONDII POLLEN; SORGHUM HALEPENSE POLLEN; TRITICUM AESTIV
UM POLLEN; TYPHA LATIFOLIA POLLEN; ZEA MAYS POLLEN .00021; .00021; .00021;
.00021; 454.5; .00021; .00125; .00125; .00125; .00125; .00125; .00125; .00125; .
00125; 454.5; .000227; .00125; .00125; .00125; .00125; .00021; .000227; .000227;
.00021; .00021; .00021; .00021; 1045.5; 454.5; .000227; .00021; 454.5; .00021;
.000227; .0025; .0025; .00021; .00021; .00021; .00021; .005; .00021; 454.5; .000
21; .00021; .000227; .000227; 454.5; .00021; .00021; .00021; .000227; 454.5; .00
021; .0025; .0025; .00021; .000227; .000227; .000227; .000227; .000227; .000227
g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL
; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/
mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL
; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL
; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/
reased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingre
dient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [E
ll-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingre
tamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],All
creased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingr
ct [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Ch
mmunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient]"
3 "Antigen Laboratories, Inc." ACREMONIUM STRICTUM; ACROTHECIUM ROBUSTU
M; APIOSPORA MONTAGNEI; CANIS LUPUS FAMILIARIS HAIR; CLADOSPORIUM CLADOSPORIOIDE
S; COCHLIOBOLUS SPICIFER; COLLETOTRICHUM COCCODES; FELIS CATUS HAIR; HUMICOLA GR
ISEA; HYPOMYCES PERNICIOSUS; KHUSKIA ORYZAE; MICROASCUS BREVICAULIS; MICROSPORUM
AUDOUINII; MICROSPORUM CANIS; MYCOCLADUS CORYMBIFERUS; MYROTHECIUM VERRUCARIA;
NEUROSPORA CRASSA; PAECILOMYCES VARIOTII; PASSALORA FULVA; PHYCOMYCES BLAKESLEEA
NUS; PLEOSPORA HERBARUM; SPORISORIUM CRUENTUM; SPOROTRICHUM PRUINOSUM; STACHYBOT
RYS CHARTARUM; STREPTOMYCES GRISEUS; SYNCEPHALASTRUM RACEMOSUM; TETRACOCCOSPORIU
M PAXIANUM; TRICHODERMA VIRIDE; TRICHOPHYTON SCHOENLEINII; TRICHOTHECIUM ROSEUM;
USTILAGO CYNODONTIS; VERTICILLIUM ALBO-ATRUM .005; .00042; .00042; .005; .005
; .00036; .00036; 500; .00042; .00036; .00036; .00036; .00042; .00042; .00042; .
00036; .00036; .00036; .00036; .00042; .00036; .0025; .00042; .00042; .00036; .0
0042; .00042; .00036; .00036; .00036; .0025; .00042 g/mL; g/mL; g/mL; g/mL;
g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL
ns [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Bacter
ial Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immu
nity [PE],Increased IgG Production [PE],Bacterial Proteins [Chemical/Ingredient]
/Ingredient]"
ACER SACCHARINUM POLLEN; ACER SACCHARUM POLLEN; AILANTHUS ALTISSIMA POLLEN; AMA
RANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLE
N; AMARANTHUS TUBERCULATUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA BIDE
NTATA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; BETULA PAPY
RIFERA POLLEN; CARPINUS CAROLINIANA POLLEN; CARYA ALBA POLLEN; CARYA OVATA POLLE
N; CELTIS OCCIDENTALIS POLLEN; CHENOPODIUM ALBUM POLLEN; CHENOPODIUM AMBROSIOIDE
S POLLEN; CHENOPODIUM BOTRYS POLLEN; FAGUS GRANDIFOLIA POLLEN; FRAXINUS AMERICAN
A POLLEN; IVA ANNUA VAR. ANNUA POLLEN; IVA XANTHIFOLIA POLLEN; JUGLANS NIGRA POL
LEN; JUNIPERUS ASHEI POLLEN; JUNIPERUS PINCHOTII POLLEN; JUNIPERUS VIRGINIANA PO
LLEN; KOCHIA SCOPARIA POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; MORUS ALBA POLLEN;
MORUS RUBRA POLLEN; PICEA PUNGENS POLLEN; PINUS STROBUS POLLEN; PLANTAGO LANCEO
LATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS ALBA POLLEN; RUMEX ACETOSELLA
POLLEN; RUMEX CRISPUS POLLEN; SALIX NIGRA POLLEN; SALSOLA KALI POLLEN .00021;
.00021; .00021; .00021; .00021; .00125; .00125; .00125; .00125; .00125; .00125;
.00125; .00125; .00021; .00021; .00021; .00021; .00021; .00167; .00167; .00167;
.00021; .00021; .0025; .0025; .00021; .00021; .00021; .00021; .005; .00021; .000
21; .00021; .00021; .00021; .005; .00021; .00021; .0025; .0025; .00021; .005
g/mL; g/mL "Non-Standardized Pollen Allergenic Extract [EPC],Increased Hist
llen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Producti
on [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens
mmunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient]"
3 "Antigen Laboratories, Inc." ALTERNARIA ALTERNATA; DERMATOPHAGOIDES P
TERONYSSINUS; EQUUS CABALLUS HAIR; FELIS CATUS HAIR .005; 300; .005; 500
g/mL; [AU]/mL; g/mL; [BAU]/mL "Non-Standardized Fungal Allergenic Extract [EPC
t],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Rel
ease [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemica
l/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Ext
d IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Pr
oteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal
munity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens
[Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient]"
3 "Antigen Laboratories, Inc." ACER NEGUNDO POLLEN; AMARANTHUS RETROFLE
XUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; ASPERGILLUS FUMIGATUS; CANIS LUPUS F
AMILIARIS HAIR; CARYA ALBA POLLEN; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FAR
INAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; MORUS ALBA POLLEN; MUCOR
RACEMOSUS; PERIPLANETA AMERICANA; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENT
ALIS POLLEN; POA PRATENSIS POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN;
SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN; URTICA D
IOICA POLLEN .002; .002; 800; .002; .00008; .002; 80; 80; 80; 16; .002; .002;
.0004; .002; .002; 4000; .002; .002; .002; .002; .002; .002 g/mL; g/mL; [AU]
/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g
/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Standardized Insect All
],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standard
ized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-media
ted Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chem
ical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingre
dient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Rel
ease [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chem
ical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides
[Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Incr
n [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Po
[Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased His
hemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased H
Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standa
rdized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-med
iated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/In
gredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine R
elease [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Pro
teins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pol
[PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized P
3 "Antigen Laboratories, Inc." ASPERGILLUS FUMIGATUS; CANIS LUPUS FAMIL
IARIS HAIR; FELIS CATUS HAIR; PHLEUM PRATENSE POLLEN .01; .01; 2000; 20000
g/mL; g/mL; [BAU]/mL; [BAU]/mL "Standardized Animal Hair Allergenic Extract [EP
oduction [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Saliv
ary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair All
E],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/I
Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],A
llergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Incr
n [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
3 "Antigen Laboratories, Inc." DERMATOPHAGOIDES FARINAE; DERMATOPHAGOID
ES PTERONYSSINUS; PERIPLANETA AMERICANA 2000; 2000; .01 [AU]/mL; [AU]/mL; g/mL
llergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],
ction [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient]
"
3 "Antigen Laboratories, Inc." AMBROSIA ARTEMISIIFOLIA POLLEN; CARYA AL
BA POLLEN; CARYA ILLINOINENSIS POLLEN; CYNODON DACTYLON POLLEN; JUGLANS NIGRA PO
LLEN; JUNIPERUS ASHEI POLLEN; PHLEUM PRATENSE POLLEN; QUERCUS ALBA POLLEN; ULMUS
AMERICANA POLLEN 10000; .002; .002; 1000; .005; .005; 800; .005; .005
[AU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL "Standardized Po
llen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen A
3 "Antigen Laboratories, Inc." AMBROSIA ARTEMISIIFOLIA POLLEN; FELIS CA
TUS HAIR; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS ASHEI POLLEN 20000; 2000; .01
; .01 [AU]/mL; [BAU]/mL; g/mL; g/mL "Standardized Animal Hair Allergenic Ext
d IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredien
t],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Pollen
ical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamin
al/Ingredient]"
3 "Antigen Laboratories, Inc." ACER NEGUNDO POLLEN; ALTERNARIA ALTERNAT
A; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; PHLEUM PRATENSE POLLEN; P
LATANUS OCCIDENTALIS POLLEN .01; .002; 80; .01; 800; .01 g/mL; g/mL; [BAU
]/mL; g/mL; g/mL; g/mL "Non-Standardized Fungal Allergenic Extract [EPC],Increa
3 "Antigen Laboratories, Inc." CANIS LUPUS FAMILIARIS HAIR; FELIS CATUS
HAIR .01; 400 g/mL; [BAU]/mL "Standardized Animal Hair Allergenic Ext
t],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal
Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Imm
unity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Ch
emical/Ingredient]"
A; AMBROSIA ARTEMISIIFOLIA POLLEN; ASPERGILLUS FUMIGATUS; CARYA ALBA POLLEN; CAR
YA ILLINOINENSIS POLLEN; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PLATANUS OCCI
DENTALIS POLLEN; QUERCUS ALBA POLLEN; ULMUS AMERICANA POLLEN .005; .005; 1000
0; .005; .005; .005; .005; .005; .002; .005 g/mL; g/mL; g/mL; g/mL; g/mL; g/
mL; g/mL; g/mL; [Amb'a'1'U]/mL; g/mL "Non-Standardized Fungal Allergenic Extr
xtract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increa
sed IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredi
dient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release
XUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENS
IS POLLEN; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; FRAXINUS AMERICANA
POLLEN; IVA ANNUA VAR. ANNUA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS ASHEI POLL
EN; MORUS ALBA POLLEN; PERIPLANETA AMERICANA; PHLEUM PRATENSE POLLEN; PLATANUS O
CCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; SALSOLA KALI
POLLEN; ULMUS AMERICANA POLLEN .002; .002; 4000; .002; .002; 400; 400; .002; .0
02; .002; .002; .002; .002; 4000; .002; .002; .002; .002; .002 g/mL; g/mL; [AU]
/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/
mL; g/mL; g/mL; g/mL; g/mL "Standardized Insect Allergenic Extract [EPC],In
ion [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemi
cal/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergen
creased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Che
mical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histami
mmunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergen
s [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increas
PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardize
ens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased
llergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],
ction [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Stan
A; AMBROSIA ARTEMISIIFOLIA POLLEN; ASPERGILLUS FUMIGATUS; CANIS LUPUS FAMILIARIS
HAIR; FELIS CATUS HAIR; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; JUNIPE
RUS ASHEI POLLEN; PHLEUM PRATENSE POLLEN; PLATANUS OCCIDENTALIS POLLEN; ULMUS AM
ERICANA POLLEN .002; .002; 4000; .002; .002; 400; .002; .002; .002; 4000; .002;
.002 g/mL; g/mL; [AU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g
/mL; g/mL "Non-Standardized Fungal Allergenic Extract [EPC],Increased Hist
amine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredi
[Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Incr
n [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardize
lergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],I
tion [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardi
A; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; ASPERGILLUS FU
MIGATUS; CANIS LUPUS FAMILIARIS HAIR; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POL
LEN; CLADOSPORIUM HERBARUM; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; D
ERMATOPHAGOIDES PTERONYSSINUS; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA P
OLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS ASHEI POLLEN; PENICILLIUM CHRYSOGENUM VAR
. CHRYSOGENUM; PERIPLANETA AMERICANA; PHLEUM PRATENSE POLLEN; PLATANUS OCCIDENTA
LIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; SALSOLA KALI POLLEN;
ULMUS AMERICANA POLLEN .002; .0004; .002; 4000; .002; .002; .001; .001; .002; 4
00; 400; 400; .002; .002; .002; .002; .002; .002; 4000; .002; .002; .002; .002;
.002 g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL;
[AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL;
g/mL "Standardized Insect Allergenic Extract [EPC],Increased Histamine Releas
s [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased H
Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingre
t [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Prot
ergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EP
oduction [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Stan
dardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-m
ediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/In
gredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Ext
d IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/
Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine
Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal P
roteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized P
ergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC]"
3 "Antigen Laboratories, Inc." ALTERNARIA ALTERNATA; AMBROSIA ARTEMISII
FOLIA POLLEN; CANIS LUPUS FAMILIARIS HAIR; CARYA ALBA POLLEN; CARYA ILLINOINENSI
S POLLEN; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PT
ERONYSSINUS; FELIS CATUS HAIR; IVA ANNUA VAR. ANNUA POLLEN; PHLEUM PRATENSE POLL
EN; PLATANUS OCCIDENTALIS POLLEN; QUERCUS ALBA POLLEN; ULMUS AMERICANA POLLEN
.002; 4000; .002; .001; .001; 400; 400; 400; 400; .002; 4000; .002; .002; .002
g/mL; [AU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; [BA
U]/mL; g/mL; g/mL; g/mL "Standardized Insect Allergenic Extract [EPC],Increased
edient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [
Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins
ns [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Incre
[PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Prot
eins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic
ased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredien
redient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Releas
l/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Ext
t],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE]
HAIR; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CLADOSPORIUM HERBARUM; CYN
ODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS;
FELIS CATUS HAIR; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; PENICILLIUM C
HRYSOGENUM VAR. CHRYSOGENUM; PERIPLANETA AMERICANA; PHLEUM PRATENSE POLLEN; POPU
LUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; SALSOLA KALI POLLEN .002; .002; 4000
; .002; .0004; .001; .001; .002; 400; 400; 400; .002; .002; .002; .002; .002; 40
00; .002; .002; .002 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]
/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g
/mL "Standardized Insect Allergenic Extract [EPC],Increased Histamine Releas
ical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allerg
Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/I
ngredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized
Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-medi
ated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Aller
gens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Incr
n [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non
3 "Antigen Laboratories, Inc." ACER NEGUNDO POLLEN; AGROSTIS GIGANTEA P
OLLEN; ANTHOXANTHUM ODORATUM POLLEN; ANTHOXANTHUM ODORATUM POLLEN; DACTYLIS GLOM
ERATA POLLEN; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; FRAXINUS PENN
SYLVANICA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS VIRGINIANA POLLEN; LOLIUM PERE
NNE POLLEN; POA PRATENSIS POLLEN; ULMUS AMERICANA POLLEN .005; 1428.6; 14
28.6; 1428.6; 1428.6; 1428.6; .0025; .0025; .005; .005; 1428.6; 1428.6; .005
g/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL;
[BAU]/mL; [BAU]/mL; g/mL "Non-Standardized Pollen Allergenic Extract [EPC
ergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increa
[Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standard
3 "Antigen Laboratories, Inc." ACER RUBRUM POLLEN; ALTERNARIA ALTERNATA
; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; CARYA ALBA POLL
EN; CLADOSPORIUM CLADOSPORIOIDES; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARI
NAE; DERMATOPHAGOIDES PTERONYSSINUS; MORUS RUBRA POLLEN; MUCOR RACEMOSUS; PLANTA
GO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; PLEOSPORA HERBARUM; POA PRAT
ENSIS POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN;
SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN .0004; .
0004; .0004; 800; .002; .002; 80; 120; 120; .002; .002; .0004; .0004; .002; 32;
.0004; .0004; .0004; .00008; .0004; .002 g/mL; g/mL; g/mL; [AU]/mL; g/mL;
g/mL; [BAU]/mL; [AU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL;
PC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemica
xtract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [C
hemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredi
ent],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [P
E],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatoph
agoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [C
hemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased H
Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standa
iated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingr
edient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extra
IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/In
emical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergeni
reased IgG Production [PE]"
3 "Antigen Laboratories, Inc." AMBROSIA ARTEMISIIFOLIA POLLEN; CANIS LU
PUS FAMILIARIS HAIR 800; .05 [AU]/mL; g/mL "Non-Standardized Animal
hemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Hista
en [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
3 "Antigen Laboratories, Inc." DERMATOPHAGOIDES FARINAE; DERMATOPHAGOID
ES PTERONYSSINUS 400; 2000 [AU]/mL; [AU]/mL "Standardized In
sect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Imm
unity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/In
gredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],
Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Ce
ll-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoid
es [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemic
al/Ingredient]"
3 "Antigen Laboratories, Inc." ACER NEGUNDO POLLEN; ALNUS RHOMBIFOLIA P
OLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; BETULA POPU
LIFOLIA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; DACTYLIS GLOMERAT
A POLLEN; FELIS CATUS HAIR; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS ASHEI POLLEN;
LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN; QUERCUS AL
BA POLLEN; ULMUS AMERICANA POLLEN .002; .002; 800; 4000; .002; .001; .001;
4000; 400; .002; .002; 4000; 4000; 4000; .002; .002 g/mL; g/mL; [AU]/mL; [BA
U]/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; [BA
U]/mL; g/mL; g/mL "Non-Standardized Pollen Allergenic Extract [EPC],Increa
[PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized A
nimal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediat
ed Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Alle
rgens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient]
nt],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC]
tion [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
3 "Antigen Laboratories, Inc." AMBROSIA ARTEMISIIFOLIA POLLEN; ANTHOXAN
THUM ODORATUM POLLEN; CYNODON DACTYLON POLLEN; DACTYLIS GLOMERATA POLLEN; DERMAT
OPHAGOIDES PTERONYSSINUS; LOLIUM PERENNE POLLEN; POA PRATENSIS POLLEN; SORGHUM H
ALEPENSE POLLEN 4000; 4000; 2000; 4000; 2000; 4000; 4000; .01 [AU]/mL; [BAU]/m
L; [BAU]/mL; [BAU]/mL; [AU]/mL; [BAU]/mL; [BAU]/mL; g/mL "Standardized Po
cal/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine
l/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine R
elease [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens,
Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],All
OLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; BETULA POPULIFOLIA POLLEN; BOS TAURUS HAI
R; CLADOSPORIUM HERBARUM; COCHLIOBOLUS SATIVUS; CYNODON DACTYLON POLLEN; DACTYLI
S GLOMERATA POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; EP
ICOCCUM NIGRUM; FELIS CATUS HAIR; LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLEN;
POA PRATENSIS POLLEN; QUERCUS ALBA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPEN
SE POLLEN .002; .002; 4000; .002; .002; .002; .002; 400; 4000; 400; 400; .
002; 400; 4000; 4000; 4000; .002; .002; .002 g/mL; g/mL; [AU]/mL; g/mL; g/mL;
g/mL; g/mL; [BAU]/mL; [BAU]/mL; [AU]/mL; [AU]/mL; g/mL; [BAU]/mL; [BAU]/mL; [BA
U]/mL; [BAU]/mL; g/mL; g/mL; g/mL "Non-Standardized Fungal Allergenic Extr
ent],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [P
ent],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine R
elease [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens
[Chemical/Ingredient],Fur [Chemical/Ingredient],Standardized Insect Allergenic E
sed IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect
Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Inse
ct Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immun
ity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingr
edient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],No
n-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],
Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemi
redient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine R
elease [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Ch
emical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptide
s [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased H
Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen
en [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Productio
ell-mediated Immunity [PE]"
A; AMBROSIA ARTEMISIIFOLIA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; BETULA POPULIFO
LIA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; COCHLIOBOLUS SATIVUS;
CYNODON DACTYLON POLLEN; DACTYLIS GLOMERATA POLLEN; DERMATOPHAGOIDES PTERONYSSI
NUS; EPICOCCUM NIGRUM; JUNIPERUS ASHEI POLLEN; LOLIUM PERENNE POLLEN; PERIPLANET
A AMERICANA; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; POA PRATENSIS P
OLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; SALSOLA KALI POLLEN; SORGH
UM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN .002; .002; 4000; 4000; .002; .0
01; .001; .002; 400; 4000; 400; .002; .002; 4000; .002; 4000; .002; 4000; .002;
.002; .002; .002; .002 g/mL; g/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [
BAU]/mL; [BAU]/mL; [AU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; [BAU]/mL
; g/mL; g/mL; g/mL; g/mL; g/mL "Standardized Insect Allergenic Extract [EPC],In
cal/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergen
creased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Che
llen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Inse
ity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],All
[Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Hi
ollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen
ngredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine
Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [C
],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical
/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamin
[PE]"
3 "Antigen Laboratories, Inc." BOS TAURUS HAIR; CANIS LUPUS FAMILIARIS
HAIR; CAPRA HIRCUS HAIR; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINU
S; FELIS CATUS HAIR; MUCOR RACEMOSUS; PERIPLANETA AMERICANA; SUS SCROFA HAIR
.002; .002; .002; 400; 400; 400; .002; .002; .002 g/mL; g/mL; g/mL; [AU]/m
L; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL "Standardized Insect Allergenic Extract
Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Protein
s [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Alle
],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient]
,Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardi
zed Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-m
ediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient]
,Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingred
ient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine
Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chem
ical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allerge
emical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increas
PE],Allergens [Chemical/Ingredient],Fur [Chemical/Ingredient],Non-Standardized A
ed Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allerge
ns [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],I
tion [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standard
ized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-media
ted Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingred
OLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; ANTHOXANTH
UM ODORATUM POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM A
LBUM POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR.
ANNUA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS ASHEI POLLEN; LOLIUM PERENNE POLLE
N; MORUS ALBA POLLEN; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATAN
US OCCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACE
TOSELLA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA P
OLLEN .002; .002; .002; 4000; 4000; .001; .001; .002; 400; .002; .002; .002; .
002; 4000; .002; 4000; .002; .002; .002; .002; .002; .002; .002; .002 g/mL; g/
mL; g/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL;
[BAU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL
hemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergen
[PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemica
Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allerge
3 "Antigen Laboratories, Inc." AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA
ARTEMISIIFOLIA POLLEN; CANIS LUPUS FAMILIARIS HAIR; CARYA ALBA POLLEN; CELTIS OC
CIDENTALIS POLLEN; FELIS CATUS HAIR; JUGLANS CALIFORNICA POLLEN; PHLEUM PRATENSE
POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; QUERCUS ALBA
POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; URTICA DIOICA POLLEN
.002; 4000; .002; .002; .002; 400; .002; 4000; .002; .002; .002; .002; .002; .00
2 g/mL; [AU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; g
/mL; g/mL; g/mL; g/mL "Standardized Animal Hair Allergenic Extract [EPC],Incre
eins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic
ract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [
gredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunit
y [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Hist
amine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Aller
cal/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated I
mmunity [PE],Increased IgG Production [PE],Increased Histamine Release [PE],Poll
FOLIA POLLEN; ASPERGILLUS FUMIGATUS; JUGLANS NIGRA POLLEN; POPULUS DELTOIDES POL
LEN; QUERCUS ALBA POLLEN; SALSOLA KALI POLLEN .005; 10000; .005; .005; .005; .
005; .005 g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Non-Standardize
cal/Ingredient]"
3 "Antigen Laboratories, Inc." AMBROSIA ARTEMISIIFOLIA POLLEN; ANTHOXAN
THUM ODORATUM POLLEN; BOS TAURUS HAIR; CANIS LUPUS FAMILIARIS HAIR; CAPRA HIRCUS
HAIR; CYNODON DACTYLON POLLEN; FELIS CATUS HAIR; IVA ANNUA VAR. ANNUA POLLEN; J
UNIPERUS ASHEI POLLEN; LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLEN; PLANTAGO L
ANCEOLATA POLLEN; SORGHUM HALEPENSE POLLEN; SUS SCROFA HAIR 4000; 800; .002;
.002; .002; 400; 400; .002; .002; 800; 800; .0002; .002; .002 [AU]/mL; [BAU]/m
L; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g
/mL; g/mL "Standardized Pollen Allergenic Extract [EPC],Increased Histamin
cal/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allerge
ncreased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/In
gredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized
Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-media
ted Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allerg
nt],Fur [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [E
roduction [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Sta
XUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; CARYA
ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTY
LON POLLEN; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; JUGLANS NIGR
A POLLEN; JUNIPERUS ASHEI POLLEN; LOLIUM PERENNE POLLEN; MORUS ALBA POLLEN; MUCO
R RACEMOSUS; PERIPLANETA AMERICANA; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOLATA
POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POL
LEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; ULM
US AMERICANA POLLEN .002; .002; 4000; 4000; .001; .001; .002; 400; .002; .00
2; .002; .002; 4000; .002; .002; .002; 4000; .002; .002; .002; .002; .002; .002;
.002; .002 g/mL; g/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL;
g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL;
g/mL; g/mL; g/mL; g/mL "Standardized Pollen Allergenic Extract [EPC],Increased
n [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized
ns [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased
d Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient
C],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/In
gredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient]"
3 "Antigen Laboratories, Inc." ALTERNARIA ALTERNATA; CANIS LUPUS FAMILI
ARIS HAIR; FELIS CATUS HAIR .01; .002; 400 g/mL; g/mL; [BAU]/mL "Standar
edient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamin
e Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Ch
FOLIA POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; JUNIPERUS VIRGIN
IANA POLLEN; MORUS RUBRA POLLEN; PLATANUS OCCIDENTALIS POLLEN .00017; 16666; 8
33.33; 1.33; .0083; .0083; .0083 g/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL;
gal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized
Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-media
ted Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],All
ergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient
],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],
Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophago
ides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chem
ical/Ingredient]"
3 "Antigen Laboratories, Inc." ACER RUBRUM POLLEN; AMARANTHUS RETROFLEX
US POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; CARYA ALBA POLLEN; CARYA ALBA POLLEN;
CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSIN
US; FELIS CATUS HAIR; MORUS ALBA POLLEN; POA PRATENSIS POLLEN; QUERCUS ALBA POLL
EN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN .002; .0004; 800; .0004;
.002; 80; 80; 80; 80; .002; 160; .0004; .0004; .002 g/mL; g/mL; [AU]/mL; g/m
L; g/mL; [BAU]/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL
llergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC]
uction [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivar
y Proteins and Peptides [Chemical/Ingredient],Standardized Pollen Allergenic Ext
ARTEMISIIFOLIA POLLEN; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; DERMAT
OPHAGOIDES PTERONYSSINUS; PLANTAGO LANCEOLATA POLLEN; POA PRATENSIS POLLEN; QUER
CUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE
POLLEN .0002; 160; 3.2; 3.2; 16; .0002; 6.4; .0002; .0002; .0002; .000016
g/mL; [AU]/mL; [BAU]/mL; [AU]/mL; [AU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/m
L "Standardized Insect Allergenic Extract [EPC],Increased Histamine Releas
ent],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE
],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine
Release [PE],Allergens [Chemical/Ingredient]"
XUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROS
IA TRIFIDA POLLEN; BETULA NIGRA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS P
OLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POL
LEN; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; KOCHIA SCOPARIA P
OLLEN; PLANTAGO LANCEOLATA POLLEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLE
N; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; SORGHUM HA
LEPENSE POLLEN; ULMUS AMERICANA POLLEN .0017; .0017; .00056; .00056; .00056; .0
003; .00083; .00083; .0017; 66.67; .0017; .0017; .0017; .0017; .0017; 666.67; .0
003; .0017; .0017; .0017; .0003; .0017 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL
; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL
; g/mL; g/mL; g/mL "Standardized Pollen Allergenic Extract [EPC],Increased
ollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Product
ion [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens
[PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemic
[Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC]"
3 "Antigen Laboratories, Inc." ALTERNARIA ALTERNATA; ANAS PLATYRHYNCHOS
FEATHER; ANSER ANSER FEATHER; ASPERGILLUS FUMIGATUS; AUREOBASIDIUM PULLULANS VA
R. PULLUTANS; CANDIDA ALBICANS; CANIS LUPUS FAMILIARIS HAIR; CLADOSPORIUM CLADOS
PORIOIDES; COCHLIOBOLUS SATIVUS; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTER
ONYSSINUS; FELIS CATUS HAIR; FUSARIUM OXYSPORUM; GALLUS GALLUS FEATHER; PENICILL
IUM CHRYSOGENUM VAR. CHRYSOGENUM; PERIPLANETA AMERICANA; PHOMA DESTRUCTIVA; PLEO
SPORA HERBARUM; RHIZOPUS STOLONIFER; SPORISORIUM CRUENTUM; USTILAGO AVENAE; USTI
LAGO CYNODONTIS; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI
.00083; .00028; .00028; .00017; .00083; .00083; .00083; .00083; .00083; 166.67;
166.67; 166.67; .00083; .00028; .00083; .00083; .00083; .00083; .00083; .00042;
.00021; .00042; .00021; .00021; .00021 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL
; g/mL; g/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/
mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Non-Standardized Fungal Allergenic Extr
llergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Product
Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Hist
amine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Ant
igens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredie
nt],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extr
IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],N
ical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic
Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Ani
mal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated
Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allerg
ens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],N
,Cell-mediated Immunity [PE]"
3 "Antigen Laboratories, Inc." ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER
FEATHER; BETULA NIGRA POLLEN; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE;
DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; FRAXINUS AMERICANA POLLEN; GA
LLUS GALLUS FEATHER; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALB
A POLLEN; SORGHUM HALEPENSE POLLEN .000668; .000668; .002; 400; 16; 16; 400
; .002; .000668; 4000; .002; .002; .002 g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [AU
]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL "Non-Standardized Pollen
llergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Incr
n [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemica
l/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergeni
reased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingr
edient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Fe
ather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Im
munity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allerge
ns [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Incre
ased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingre
dient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extra
ct [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [
PORIOIDES; COCHLIOBOLUS SATIVUS; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARIN
AE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; FUSARIUM OXYSPORUM; GALLUS
GALLUS FEATHER; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PERIPLANETA AMERICANA
; PHOMA DESTRUCTIVA; PLEOSPORA HERBARUM; POA PRATENSIS POLLEN; RHIZOPUS STOLONIF
ER; SORGHUM HALEPENSE POLLEN; SPORISORIUM CRUENTUM; USTILAGO AVENAE; USTILAGO CY
NODONTIS; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI .00017;
.00028; .00028; .0008; .0008; .0008; .0008; .0008; .0008; 333.33; 333.33; 333.33
; 33.33; .0008; .00028; .0008; .0008; .0008; .0008; 3333.33; .0008; .0017; .0004
2; .00021; .00042; .00021; .00021; .00021 g/mL; g/mL; g/mL; g/mL; g/mL; g/
mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/
mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL
Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Hist
len [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Al
l Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated I
],Increased Histamine Release [PE],Non-Standardized Fungal Allergenic Extract [E
PC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins
cal/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Hista
mine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Inse
ct Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardiz
ed Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediate
d Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredie
nt],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [
Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingred
ient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [
PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatop
hagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [
Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Incre
[PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized
Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated
Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient
],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],I
tion [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chem
],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EP
oduction [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredie
nt],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release
[PE],Cell-mediated Immunity [PE],Increased IgG Production [PE]"
OLLEN; CHENOPODIUM ALBUM POLLEN; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA
POLLEN; JUNIPERUS VIRGINIANA POLLEN; KOCHIA SCOPARIA POLLEN; PLANTAGO LANCEOLAT
A POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN
; SALSOLA KALI POLLEN; ULMUS AMERICANA POLLEN .0017; .0017; .00011; .00011; .0
0011; .0017; .00083; .00083; .0017; .0017; .0017; .0017; .0017; .0017; .0017; .0
ell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingr
nic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Poll
en [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/In
elease [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [
ty [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standar
tion [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Stand
Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC]
uction [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Sta
A; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFID
A POLLEN; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; BETULA NIGRA POLLEN; CARYA ALB
A POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON
POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS H
AIR; FRAXINUS AMERICANA POLLEN; PERIPLANETA AMERICANA; PLANTAGO LANCEOLATA POLLE
N; PLEOSPORA HERBARUM; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; SPORISORIU
M CRUENTUM; USTILAGO CYNODONTIS .000133; .00017; .0000044; .0000044; .0000044; .
00083; .000133; .00017; .00017; .00033; 66.67; 33.33; 33.33; 33.33; .00033; .004
mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/
mL; g/mL; g/mL; g/mL; g/mL; g/mL "Non-Standardized Pollen Allergenic Extr
PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical
/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Re
ens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Incre
[PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-
Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Ce
ll-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemica
l/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic
eased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemi
cal/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Hista
mine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fung
al Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardiz
ed Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediate
d Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredie
nt],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC]
uction [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Ch
,Increased IgG Production [PE]"
3 "Antigen Laboratories, Inc." CARYA ALBA POLLEN; CARYA ILLINOINENSIS P
OLLEN; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERO
NYSSINUS; POA PRATENSIS POLLEN; RUMEX ACETOSELLA POLLEN; SORGHUM HALEPENSE POLLE
N .001; .001; 400; 80; 80; 4000; .002; .00008 g/mL; g/mL; [BAU]/mL; [A
U]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL "Non-Standardized Pollen Allergenic Extr
andardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell
-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides
[Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical
/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Re
lease [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, D
ermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Alle
rgens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cel
nt],Increased Histamine Release [PE],Allergens [Chemical/Ingredient]"
3 "Antigen Laboratories, Inc." ACER NEGUNDO POLLEN; AMBROSIA ARTEMISIIF
OLIA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; FRAXINUS AMERICANA P
OLLEN; IVA ANNUA VAR. ANNUA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS ASHEI POLLEN
; PHLEUM PRATENSE POLLEN; QUERCUS ALBA POLLEN; ULMUS AMERICANA POLLEN .0083; 1
33.33; .00083; .00083; .0083; .0017; .0017; .0017; 16666.67; .0083; .0017
g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL "Non-Sta
3 "Antigen Laboratories, Inc." CYNODON DACTYLON POLLEN; POA PRATENSIS P
OLLEN; SORGHUM HALEPENSE POLLEN 2.67; 26.67; .0000133 [BAU]/mL; [BAU]/mL; g/mL
3 "Antigen Laboratories, Inc." ACER NEGUNDO POLLEN; CYNODON DACTYLON PO
LLEN; FRAXINUS AMERICANA POLLEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN;
QUERCUS ALBA POLLEN; SORGHUM HALEPENSE POLLEN .00033; 66.67; .00033; 666.67; .
00033; .00033; .00033 g/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL
gredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract
G Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],S
XUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA TRIFIDA POLLEN; BETULA NIGR
A POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLE
N; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLL
EN; JUNIPERUS VIRGINIANA POLLEN; KOCHIA SCOPARIA POLLEN; PLANTAGO LANCEOLATA POL
LEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX
ACETOSELLA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICAN
A POLLEN .0000133; .0000133; .0000066; .0000066; .0000133; .0000066; .000
0066; .0000133; 2.67; .0000133; .00033; .0000133; .0000133; .0000133; 26.67; .00
00133; .0000133; .0000133; .0000133; .0000133; .0000133 g/mL; g/mL; g/mL; g/mL;
g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL;
duction [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standa
dardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased I
gG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE]
llen Allergenic Extract [EPC]"
LEN; CLADOSPORIUM HERBARUM; CYNODON DACTYLON POLLEN; FELIS CATUS HAIR; FRAXINUS
AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS A
SHEI POLLEN; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PHLEUM PRATENSE POLLEN; P
LATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; SALS
OLA KALI POLLEN; ULMUS AMERICANA POLLEN .0017; .00017; .0017; 133.33; .00083; .0
0083; .000165; .000165; .0000333; 333.33; 166.67; .00033; .0017; .0017; .0017; .
0042; 666.67; .0017; .0017; .0017; .0017; .00033 g/mL; g/mL; g/mL; [BAU]/
mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/
mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Non-Standardized Fungal Allerge
ated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ing
eins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal H
air Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immu
nity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [
Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-St
andardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE]
,Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredi
Cell-mediated Immunity [PE]"
3 "Antigen Laboratories, Inc." ALTERNARIA ALTERNATA; AMARANTHUS RETROFL
EXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBRO
SIA TRIFIDA POLLEN; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; ASPERGILLUS
FUMIGATUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; CANDIDA ALBICANS; CANIS LUPU
S FAMILIARIS HAIR; CLADOSPORIUM CLADOSPORIOIDES; CYNODON DACTYLON POLLEN; DERMAT
OPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; GALLUS GAL
LUS FEATHER; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PERIPLANETA AMERICANA; PH
OMA DESTRUCTIVA; PLEOSPORA HERBARUM; POA PRATENSIS POLLEN; QUERCUS ALBA POLLEN;
RHIZOPUS STOLONIFER; SORGHUM HALEPENSE POLLEN; SPORISORIUM CRUENTUM; USTILAGO AV
ENAE; USTILAGO CYNODONTIS; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITI
CI .00083; .00033; .0000044; .0000044; .0000044; .00028; .00028; .00017; .0
0083; .00017; .00083; .00017; 66.67; 166.67; 166.67; 33.33; .00028; .00083; .000
83; .00083; .00083; 133.33; .00033; .00083; .00033; .000415; .00021; .000415; .0
0021; .00021; .00021 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/
mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/
mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Standar
lergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Producti
on [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],No
Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE
],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [C
Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fu
ardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-me
diated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ing
nt],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extr
IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],N
3 "Antigen Laboratories, Inc." ACER RUBRUM POLLEN; ALTERNARIA ALTERNATA
; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AUREOBASIDIUM P
ULLULANS VAR. PULLUTANS; CANDIDA ALBICANS; CANIS LUPUS FAMILIARIS HAIR; CARYA AL
BA POLLEN; COCHLIOBOLUS SATIVUS; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARIN
AE; EPICOCCUM NIGRUM; FELIS CATUS HAIR; FUSARIUM OXYSPORUM; MUCOR RACEMOSUS; PLA
NTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; PLEOSPORA HERBARUM; POA P
RATENSIS POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLL
EN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN .004; .00008; .004; 800;
.002; .002; .002; .002; .002; 80; 400; .002; 80; .002; .002; .002; .002; .004;
160; .002; .004; .002; .0004; .004 g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g
/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL
; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Standardized Insect Allergenic
Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Ani
Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allerg
ens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],N
on-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release
[PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/In
lease [PE],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased
IgG Production [PE]"
3 "Antigen Laboratories, Inc." ACER NEGUNDO POLLEN; CARYA ALBA POLLEN;
CARYA ILLINOINENSIS POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS ASHEI POLLEN; MORUS
ALBA POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN; URTICA DIOICA POL
LEN .0083; .00085; .00085; .0083; .0017; .0083; .0083; .0017; .0083 g/mL; g/
mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Non-Standardized Pollen Allerge
mical/Ingredient]"
EXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; ASPERGILLUS FUMIGATUS; CANIS LUPUS
FAMILIARIS HAIR; CLADOSPORIUM HERBARUM; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDE
S PTERONYSSINUS; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; JUNIPER
US ASHEI POLLEN; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PHLEUM PRATENSE POLLE
N .00017; .0083; 666.67; .00083; .00083; .00017; 333.33; 833.33; .0083; .0
017; .000067; .00083; 3333.33 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; [BAU]/mL;
[AU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL "Standardized Insect Allergenic
[PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergen
s [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increas
PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-St
,Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],In
iated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient]
XUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; CANIS LUPUS FAMILIARIS HAIR; CARYA A
LBA POLLEN; CARYA ILLINOINENSIS POLLEN; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDE
S FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; FRAXINUS AMERICANA
POLLEN; IVA ANNUA VAR. ANNUA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS ASHEI POLLE
N; MORUS ALBA POLLEN; PERIPLANETA AMERICANA; PHLEUM PRATENSE POLLEN; PLATANUS OC
CIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSEL
LA POLLEN; SALSOLA KALI POLLEN; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN
.00033; .0017; 133.33; .00083; .00085; .00085; 66.67; 166.67; 166.67; 33.33; .00
17; .00033; .00033; .0017; .0083; .0042; 666.67; .00033; .0017; .00033; .00033;
.00033; .00033; .0017 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL
; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g
/mL; g/mL; g/mL; g/mL; g/mL "Standardized Insect Allergenic Extract [EPC],In
cal/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic E
Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Anim
al Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated
Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allerge
ns [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],No
n-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release
[PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ing
redient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extr
IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/I
emical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histam
n [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Alle
/Ingredient]"
FOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; ANAS PLATYR
HYNCHOS FEATHER; ANSER ANSER FEATHER; ASPERGILLUS FUMIGATUS; CANDIDA ALBICANS; C
HENOPODIUM ALBUM POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINU
S; FELIS CATUS HAIR; GALLUS GALLUS FEATHER; POA PRATENSIS POLLEN; SPORISORIUM CR
UENTUM; ULMUS AMERICANA POLLEN; USTILAGO CYNODONTIS .0042; .00011; .00011; .
00011; .0014; .0014; .0042; .0042; .00033; 833.33; 833.33; 833.33; .0014; 8333.3
3; .0021; .00033; .0021 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [A
U]/mL; g/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL "Non-Standardized Pollen
y [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized
uction [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-me
act [EPC],Increased Histamine Release [PE],Non-Standardized Fungal Allergenic Ex
tract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal
Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Anim
ns [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],No
],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Che
mical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allerg
Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [C
hemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased
,Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized
Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated
Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],No
n-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE]
,Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/
Ingredient]"
IA TRIFIDA POLLEN; ASPERGILLUS FUMIGATUS; BETULA NIGRA POLLEN; CANDIDA ALBICANS;
CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CLADOS
PORIUM CLADOSPORIOIDES; COCHLIOBOLUS SATIVUS; CYNODON DACTYLON POLLEN; FRAXINUS
AMERICANA POLLEN; FUSARIUM OXYSPORUM; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS VIR
GINIANA POLLEN; KOCHIA SCOPARIA POLLEN; PLANTAGO LANCEOLATA POLLEN; POA PRATENSI
S POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN
; SALSOLA KALI POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMER
ICANA POLLEN .002; .002; .00067; .00067; .00067; .002; .002; .002; .001; .001
; .002; .002; .002; 400; .002; .002; .002; .002; .002; .002; 4000; .002; .002; .
002; .002; .002; .002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL;
g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU
]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Non-Standardized Pollen Allerge
],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],I
lease [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Ex
llergenic Extract [EPC]"
3 "Antigen Laboratories, Inc." CYNODON DACTYLON POLLEN; DERMATOPHAGOIDE
S FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; IVA ANNUA VAR. ANNU
A POLLEN; SORGHUM HALEPENSE POLLEN 333.33; 166.67; 166.67; 1.33; .0083; .00
17 [BAU]/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL "Non-Standardize
dient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [E
roduction [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins
[Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair A
[PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemi
cal/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient]"
3 "Antigen Laboratories, Inc." ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGA
TUS; CYNODON DACTYLON POLLEN; PLANTAGO LANCEOLATA POLLEN; POA PRATENSIS POLLEN;
SORGHUM HALEPENSE POLLEN .002; .002; 400; .002; 160; .00008 g/mL; g/
mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL "Standardized Pollen Allergenic Extract
ll-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemi
en [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal
49288-0714_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0714 HUMAN PRESCRIPTI
XUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENS
IS POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. AN
NUA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS ASHEI POLLEN; PHLEUM PRATENSE POLLEN
; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; R
UMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; ULMUS AMERICANA POLLEN; URTICA DIOI
CA POLLEN .00167; .00167; 133.33; .000833; .000833; 333.33; .00033; .00033
; .00167; .00833; 16666.67; .00167; .00167; .00167; .00167; .00167; .00167; .008
33 g/mL; g/mL; [AU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]
/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Non-Standardized Pollen Allerge
edient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release
ical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic
c Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen
[Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingr
XUS POLLEN; BETULA NIGRA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN;
CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; KO
CHIA SCOPARIA POLLEN; PLANTAGO LANCEOLATA POLLEN; POA PRATENSIS POLLEN; QUERCUS
ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POL
LEN .002; .002; .002; .001; .001; .002; 400; .002; .002; .002; 160; .002; .0
02; .002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL;
[BAU]/mL; g/mL; g/mL; g/mL; g/mL "Non-Standardized Pollen Allergenic Extr
lergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE]
,Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemic
LEPENSE POLLEN; ULMUS AMERICANA POLLEN .00167; .0000133; .0000044; .0000044; .0
000044; .00167; .00083; .00083; .0000133; 333.33; .00167; .00167; .00167; .00167
; .00167; 3333.33; .0000133; .00167; .0000133; .000067; .0000133; .00167
g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL
; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Non-Standardize
llergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE
],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemi
Pollen Allergenic Extract [EPC]"
.000833; .0002783; .002783; .000833; .000833; .000833; .000833; .000833; .000833
; 166.67; 166.67; 166.67; .000833; .0002783; .000833; .000833; .000833; .000833;
.000833; .0004167; .0002083; .0004167; .0002083; .0002083; .0002083 g/mL; g/
mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL;
g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Non-Sta
Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Imm
Increased Histamine Release [PE],Non-Standardized Fungal Allergenic Extract [EPC
Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated I
mmunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient]
rgens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC
duction [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; AN
AS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; ASPERGILLUS FUMIGATUS; CANDIDA AL
BICANS; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CYNODON DACTYLON POLLEN;
FELIS CATUS HAIR; GALLUS GALLUS FEATHER; KOCHIA SCOPARIA POLLEN; POA PRATENSIS P
OLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN .0004; .0000267; .000026
7; .0000267; .00067; .00067; .002; .002; .001; .001; 400; 400; .00067; .002; 800
; .002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU
]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL "Non-Standardized Pollen
y [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standard
edient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [
/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increas
e Release [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histam
ine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredien
roduction [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Stan
dardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],C
ell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingred
ient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/I
ngredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine
Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers
[Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather
[PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standar
dized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-med
iated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredien
t]"
3 "Antigen Laboratories, Inc." FRAXINUS AMERICANA POLLEN; POA PRATENSIS
POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; SALSOLA KALI POLLEN
.00033; 3333.33; .00033; .00033; .00167 g/mL; [BAU]/mL; g/mL; g/mL; g/mL
3 "Antigen Laboratories, Inc." ALTERNARIA ALTERNATA; COCHLIOBOLUS SATIV
US; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; IVA ANNUA VAR. ANNUA POLL
EN; PHOMA DESTRUCTIVA; PLEOSPORA HERBARUM; SORGHUM HALEPENSE POLLEN .0004; .
002; 80; 2000; .01; .002; .002; .01 g/mL; g/mL; [BAU]/mL; [AU]/mL; g/mL; g/m
L; g/mL; g/mL "Standardized Insect Allergenic Extract [EPC],Increased Histamin
FEATHER; ANSER ANSER FEATHER; CANDIDA ALBICANS; CANIS LUPUS FAMILIARIS HAIR; DE
RMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; GALLUS GALLUS FEATHER; P
ERIPLANETA AMERICANA; PLEOSPORA HERBARUM; SPORISORIUM CRUENTUM; USTILAGO AVENAE;
USTILAGO CYNODONTIS; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI
.002; .00067; .00067; .00008; .002; 400; 400; .00067; .002; .00008; .001; .00002
; .001; .00002; .00002; .00002 g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL;
g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Standardized Insect All
],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Stan
dardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-m
ediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/In
gredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergeni
reased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredi
ent],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Releas
e [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins
[Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather
[PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Ch
emical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased H
istamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient]
,Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EP
C],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemic
al/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Ex
ed IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect P
roteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immu
nity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Al
lergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],I
ncreased Histamine Release [PE],Non-Standardized Fungal Allergenic Extract [EPC]
uction [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient
],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [
PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [C
hemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Alle
],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens
[Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased
],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Stan
roteins [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
LEN; JUNIPERUS VIRGINIANA POLLEN; KOCHIA SCOPARIA POLLEN; PLANTAGO LANCEOLATA PO
LLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SA
LSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN .002; .002; .00067; .00067; .000
67; .002; .001; .001; .002; 400; .00008; .00008; .002; .002; .002; .00008; .002;
.002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL;
g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Non-Standardized Pollen
Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [
PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Che
mical/Ingredient]"
A POLLEN; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; ASPERGILLUS FUMIGATUS
; BETULA NIGRA POLLEN; CANIS LUPUS FAMILIARIS HAIR; CARYA ALBA POLLEN; CARYA ILL
INOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; DERMATOPHA
GOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; GALLUS GALLUS
FEATHER; PERIPLANETA AMERICANA; PLANTAGO LANCEOLATA POLLEN; POA PRATENSIS POLLEN
; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOL
A KALI POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN; USTILAGO AVENAE
; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI .002; .002; .000
13; .00013; .00013; .00067; .00067; .002; .002; .002; .001; .001; .002; 80; 400;
400; 80; .00067; .002; .002; 800; .002; .002; .002; .002; .0004; .002; .0005; .
mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; [B
AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Non-Sta
sed IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingre
dient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Rel
ease [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [
Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased
Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredien
t],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],
ction [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Che
mical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic
eased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insec
t Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized An
imal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediate
d Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Aller
gens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],
Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Releas
e [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/I
ty [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standar
lergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],C
ell-mediated Immunity [PE],Increased IgG Production [PE]"
3 "Antigen Laboratories, Inc." ACER NEGUNDO POLLEN; AUREOBASIDIUM PULLU
LANS VAR. PULLUTANS; BETULA NIGRA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS
POLLEN; CHENOPODIUM ALBUM POLLEN; CLADOSPORIUM CLADOSPORIOIDES; COCHLIOBOLUS SA
TIVUS; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR
; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS VIRGINIANA P
OLLEN; KOCHIA SCOPARIA POLLEN; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PERIPLA
NETA AMERICANA; PLEOSPORA HERBARUM; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLL
EN; QUERCUS ALBA POLLEN; RHIZOPUS STOLONIFER; SORGHUM HALEPENSE POLLEN; USTILAGO
AVENAE; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI .0004; .
00004; .002; .00004; .00004; .0004; .0004; .002; 16; 80; 400; .002; .002; .00008
; .002; .0004; .002; .002; 160; .0004; .002; .00004; .002; .0004; .0004; .0004;
.0004 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [BAU]
/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL;
ient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Rele
ase [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemi
cal/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [
len [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insec
t Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immuni
ty [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Alle
rgens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC]"
OLIA POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; FESTUCA PRATENSI
S POLLEN; LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOLATA POL
LEN; POA PRATENSIS POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS
AMERICANA POLLEN .002; 160; .0004; 80; 800; 800; 800; .002; 800; .0004; .
0004; .002 g/mL; [AU]/mL; g/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/m
L; [BAU]/mL; g/mL; g/mL; g/mL "Standardized Pollen Allergenic Extract [EPC],In
OLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; KOCHIA SCOPARIA POLLEN
; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; SALSOLA K
ALI POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN .002; .002; .000
13; .00013; .00013; .002; .00004; .00004; .002; 16; .002; 4000; .002; .002; .002
; .002; .00008 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL;
g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Non-Standardized Pollen Allerge
ty [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardize
ncreased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ing
nt]"
IA TRIFIDA POLLEN; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; AUREOBASIDIU
M PULLULANS VAR. PULLUTANS; BETULA NIGRA POLLEN; CANDIDA ALBICANS; CANIS LUPUS F
AMILIARIS HAIR; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM
POLLEN; CLADOSPORIUM CLADOSPORIOIDES; CYNODON DACTYLON POLLEN; GALLUS GALLUS FE
ATHER; IVA ANNUA VAR. ANNUA POLLEN; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PE
RIPLANETA AMERICANA; PHOMA DESTRUCTIVA; PLANTAGO LANCEOLATA POLLEN; PLEOSPORA HE
RBARUM; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN;
SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; SPORISORIUM CRUENTUM; USTILAGO CY
NODONTIS .002; .00008; .0000267; .0000267; .0000267; .00067; .00067; .002
; .00008; .00008; .0004; .001; .001; .00008; .002; 400; .00067; .00008; .002; .0
02; .002; .00008; .00008; .00008; .002; .002; .002; .002; .001; .001 g/mL; g/
; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/
Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [P
E],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingre
dient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extrac
gG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ing
redient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine R
PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardi
zed Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-media
ted Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient]
G Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],C
c Extract [EPC],Increased Histamine Release [PE],Non-Standardized Fungal Allerge
3 "Antigen Laboratories, Inc." ACER NEGUNDO POLLEN; ASPERGILLUS FUMIGAT
US; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; BETULA NIGRA POLLEN; CARYA ALBA POLL
EN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CLADOSPORIUM CLADOSPOR
IOIDES; COCHLIOBOLUS SATIVUS; FUSARIUM OXYSPORUM; IVA ANNUA VAR. ANNUA POLLEN; K
OCHIA SCOPARIA POLLEN; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PHOMA DESTRUCTI
VA; PLEOSPORA HERBARUM; RHIZOPUS STOLONIFER; RUMEX ACETOSELLA POLLEN; SPORISORIU
M CRUENTUM; USTILAGO AVENAE; USTILAGO CYNODONTIS; USTILAGO MAYDIS; USTILAGO NUDA
HORDEI; USTILAGO TRITICI .002; .002; .002; .002; .001; .001; .0004; .002;
.002; .00008; .002; .002; .002; .002; .00008; .00008; .002; .001; .00002; .001;
zed Pollen Allergenic Extract [EPC],Increased Histamine Release [PE]"
0267; .00008; .00004; .00004; .00008; 16; .00008; .00008; .00008; .00008; .002;
160; .00008; .00008; .00008; .00008; .00008; .00008 g/mL; g/mL; g/mL; g/mL;
g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL;
g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Standardized Pollen Allergenic Extract
t [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Che
mical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic
t [EPC]"
TUS; CANIS LUPUS FAMILIARIS HAIR; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTE
RONYSSINUS; FELIS CATUS HAIR; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PLEOSPOR
A HERBARUM; SPORISORIUM CRUENTUM; USTILAGO AVENAE; USTILAGO CYNODONTIS; USTILAGO
MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI .00008; .002; .002; 400; 400; 16
; .002; .00008; .00004; .00002; .00004; .00002; .00002; .00002 g/mL; g/mL; g/mL
; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL
,Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Relea
Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extra
IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Prot
ion [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
OLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; ANAS PLATYRH
YNCHOS FEATHER; ANSER ANSER FEATHER; ASPERGILLUS FUMIGATUS; AUREOBASIDIUM PULLUL
ANS VAR. PULLUTANS; CANDIDA ALBICANS; CANIS LUPUS FAMILIARIS HAIR; DERMATOPHAGOI
DES PTERONYSSINUS; FRAXINUS AMERICANA POLLEN; GALLUS GALLUS FEATHER; JUNIPERUS V
IRGINIANA POLLEN; PLANTAGO LANCEOLATA POLLEN; PLEOSPORA HERBARUM; POA PRATENSIS
POLLEN; QUERCUS ALBA POLLEN; RHIZOPUS STOLONIFER .002; .00013; .00013; .0
0013; .00067; .00067; .002; .002; .002; .002; 400; .002; .00067; .00008; .00008;
.002; 4000; .002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/
mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL "Standardized Po
Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic
ased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingr
edient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Re
lease [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens
[Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increase
d Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredie
Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Pro
teins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fun
gal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized P
d Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/I
A; BETULA NIGRA POLLEN; CANDIDA ALBICANS; CLADOSPORIUM CLADOSPORIOIDES; DERMATOP
HAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; FUSARIUM OXY
SPORUM; KOCHIA SCOPARIA POLLEN; PLANTAGO LANCEOLATA POLLEN; POPULUS DELTOIDES PO
LLEN; SORGHUM HALEPENSE POLLEN .002; .002; .002; .002; .002; 400; 400; 400; .00
2; .002; .002; .002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL;
[BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Standardized Animal Hair Allergenic Ext
t],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Insect Alle
,Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Stand
redient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract
s [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen
ical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Funga
d Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardi
hemical/Ingredient],Allergens [Chemical/Ingredient]"
A; AMBROSIA ARTEMISIIFOLIA POLLEN; LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLEN
; POA PRATENSIS POLLEN; QUERCUS ALBA POLLEN; ULMUS AMERICANA POLLEN .01; .01
; 800; 4000; 20000; 4000; .002; .01 g/mL; g/mL; [AU]/mL; [BAU]/mL; [BAU]/mL;
[BAU]/mL; g/mL; g/mL "Non-Standardized Fungal Allergenic Extract [EPC],Increa
[PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Stand
TUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; CANDIDA ALBICANS; CANIS LUPUS FAMIL
IARIS HAIR; CLADOSPORIUM CLADOSPORIOIDES; COCHLIOBOLUS SATIVUS; DERMATOPHAGOIDES
FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; FUSARIUM OXYSPORUM;
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PERIPLANETA AMERICANA; PHOMA DESTRUCTI
VA; PLEOSPORA HERBARUM; RHIZOPUS STOLONIFER; SPORISORIUM CRUENTUM; USTILAGO AVEN
AE; USTILAGO CYNODONTIS; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI
.00008; .0004; .00008; .00008; .002; .00008; .00008; 16; 16; 16; .0004; .0004; .
0004; .0004; .0004; .002; .001; .0005; .001; .0005; .0005; .0005 g/mL; g/
mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL;
g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Standardized Animal Hai
r Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immuni
ty [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Ch
emical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standard
ted Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chem
ical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingre
ns [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal
hemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased H
Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardiz
d Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemic
al/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredi
ent],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [
ergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Fungal A
ine Release [PE],Cell-mediated Immunity [PE]"
LEN; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; PLANTAGO LANCEOLA
TA POLLEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN;
SORGHUM HALEPENSE POLLEN .002; .002; .0000267; .0000267; .0000267; .002;
.00004; .00004; .002; 16; .00008; .002; .0004; .00008; 160; .002; .002; .0004
g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL
; g/mL; [BAU]/mL; g/mL; g/mL; g/mL "Standardized Pollen Allergenic Extract
Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ing
Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Poll
en [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen All
ased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredi
OLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; BETULA NIGRA
POLLEN; CANDIDA ALBICANS; CANIS LUPUS FAMILIARIS HAIR; CARYA ALBA POLLEN; CARYA
ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; DERMATOPHAGOIDES FARINAE; DERMA
TOPHAGOIDES PTERONYSSINUS; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLE
N; JUNIPERUS VIRGINIANA POLLEN; PERIPLANETA AMERICANA; PLANTAGO LANCEOLATA POLLE
N; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX AC
ETOSELLA POLLEN; SALSOLA KALI POLLEN; ULMUS AMERICANA POLLEN; USTILAGO AVENAE; U
STILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI .000078; .0000267; .0000
267; .0000267; .00008; .002; .002; .00004; .00004; .002; 16; 400; .00008; .00008
; .002; .00008; .00008; 160; .00008; .00008; .002; .002; .002; .00002; .00002; .
00002; .00002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]
/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/
mL; g/mL; g/mL; g/mL; g/mL "Standardized Pollen Allergenic Extract [EPC],In
d Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemic
al/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredi
Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Poll
ne Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allerge
ted Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingred
ient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EP
oduction [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [
l/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal P
roteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized F
ungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized
ediated Immunity [PE]"
FOLIA POLLEN; DERMATOPHAGOIDES FARINAE; PHLEUM PRATENSE POLLEN; QUERCUS ALBA POL
LEN .002; 4000; 400; 4000; .0004 g/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL
HYNCHOS FEATHER; ANSER ANSER FEATHER; ASPERGILLUS FUMIGATUS; AUREOBASIDIUM PULLU
LANS VAR. PULLUTANS; CANIS LUPUS FAMILIARIS HAIR; CLADOSPORIUM CLADOSPORIOIDES;
COCHLIOBOLUS SATIVUS; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; FELIS C
ATUS HAIR; FUSARIUM OXYSPORUM; GALLUS GALLUS FEATHER; JUNIPERUS VIRGINIANA POLLE
N; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PERIPLANETA AMERICANA; PHOMA DESTRU
CTIVA; PLEOSPORA HERBARUM; POA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN; SPORI
SORIUM CRUENTUM; ULMUS AMERICANA POLLEN; USTILAGO CYNODONTIS .00008; .00067;
.00067; .00067; .00067; .00067; .002; .002; .002; .002; .002; 16; 16; 400; .002;
.00067; .002; .002; .002; .002; .00008; 160; .00008; .001; .002; .001 g/mL; g/
mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [BA
U]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/m
L "Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine R
Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect
y [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingred
ient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-
ed Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-me
diated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],All
ergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],In
ion [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],N
on-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE
],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/I
rs [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feathe
ty [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardi
ated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ing
,Cell-mediated Immunity [PE],Increased IgG Production [PE]"
IA TRIFIDA POLLEN; BETULA NIGRA POLLEN; CANIS LUPUS FAMILIARIS HAIR; CARYA ALBA
POLLEN; CARYA ILLINOINENSIS POLLEN; CLADOSPORIUM CLADOSPORIOIDES; CYNODON DACTYL
ON POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; FRAXINUS AMERICANA
POLLEN; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; PERIPLANETA AM
ERICANA; PLEOSPORA HERBARUM; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; QUE
RCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENS
E POLLEN; SPORISORIUM CRUENTUM; USTILAGO AVENAE; USTILAGO CYNODONTIS; USTILAGO M
AYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI .002; .002; .0000267; .0000267;
.0000267; .00008; .0004; .001; .001; .002; 400; 16; 16; .002; .002; .002; .00008
; .002; 160; .002; .002; .002; .002; .002; .001; .0005; .001; .0005; .0005; .000
5 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [A
U]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL;
g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Standardized Animal Hair Allerg
ngredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Pol
Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],
ated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],
Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Releas
e [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/I
ngredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Ex
ed IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical
t Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardize
IA TRIFIDA POLLEN; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; CANIS LUPUS FAMILIARI
S HAIR; CHENOPODIUM ALBUM POLLEN; CLADOSPORIUM CLADOSPORIOIDES; COCHLIOBOLUS SAT
IVUS; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERON
YSSINUS; FELIS CATUS HAIR; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLE
N; JUNIPERUS VIRGINIANA POLLEN; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PHOMA
DESTRUCTIVA; POPULUS DELTOIDES POLLEN; RHIZOPUS STOLONIFER; SALSOLA KALI POLLEN;
SPORISORIUM CRUENTUM; USTILAGO CYNODONTIS .00008; .002; .0000267; .0000267
; .0000267; .002; .002; .002; .002; .002; 400; 400; 400; 16; .002; .0004; .00008
; .002; .00008; .00008; .002; .002; .001; .001 g/mL; g/mL; g/mL; g/mL; g/mL; g/
mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/
mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Standardized Animal Hair Allerg
ngredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Ins
ect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immu
nity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ing
redient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],N
gredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Relea
c Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pol
len [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Anima
l Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated I
mmunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [
len [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Al
PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredien
t],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Sta
[PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins
[Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Al
PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergen
andardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell
-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/
Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic E
sed IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemica
mical/Ingredient]"
TUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; CANDIDA ALBICANS; CANIS LUPUS FAMIL
IARIS HAIR; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FUSARIUM O
XYSPORUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PERIPLANETA AMERICANA; PHOMA
DESTRUCTIVA; PLEOSPORA HERBARUM; RHIZOPUS STOLONIFER .002; .002; .002; .002;
.002; 16; 16; .002; .002; .002; .002; .002; .002 g/mL; g/mL; g/mL; g/mL;
g/mL; [AU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Standardized In
mical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair A
[PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical
/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamin
e Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect
edient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Ce
Extract [EPC],Increased Histamine Release [PE],Non-Standardized Fungal Allergen
ic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fu
ngal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standard
ient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract
G Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingr
edient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Rel
ease [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Prote
ins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Funga
l Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immuni
ty [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Alle
rgens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Inc
cal/Ingredient],Allergens [Chemical/Ingredient]"
LEN; IVA ANNUA VAR. ANNUA POLLEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN
; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; SORGHUM HAL
EPENSE POLLEN .00008; .002; .00067; .00067; .00067; .00008; .0002; .0002; .002
; 16; .00008; .002; 4000; .00008; .0004; .002; .002; .002 g/mL; g/mL; g/mL
; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL
munity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standar
len Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Productio
n [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [
OLLEN; PLANTAGO LANCEOLATA POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN
; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN
.00008; .00008; .00013; .00013; .00013; .0004; .0000267; .0000267; .002; 16; .00
2; .00008; .00008; .002; .00008; .00008; .002; .002; .002; .002 g/mL; g/mL; g/mL
; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/
mL; g/mL; g/mL; g/mL; g/mL "Non-Standardized Pollen Allergenic Extract [EPC
ic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Polle
n [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ing
y [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standard
FEATHER; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; CANDIDA ALBICANS; CANIS LUPUS F
AMILIARIS HAIR; CLADOSPORIUM CLADOSPORIOIDES; COCHLIOBOLUS SATIVUS; DERMATOPHAGO
IDES PTERONYSSINUS; FUSARIUM OXYSPORUM; GALLUS GALLUS FEATHER; PENICILLIUM CHRYS
OGENUM VAR. CHRYSOGENUM; PERIPLANETA AMERICANA; PHOMA DESTRUCTIVA; PLEOSPORA HER
BARUM; RHIZOPUS STOLONIFER; SPORISORIUM CRUENTUM; USTILAGO AVENAE; USTILAGO CYNO
DONTIS; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI .0000267; .00002
67; .00008; .002; .002; .00008; .00008; 16; .00008; .0000267; .00008; .00008; .0
0008; .00008; .00008; .001; .0005; .001; .0005; .0005; .0005 g/mL; g/mL; g/mL
; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/m
L; g/mL; g/mL; g/mL; g/mL; g/mL "Non-Standardized Feather Allergenic Extract [EP
oduction [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non
-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],
Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/I
Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allerge
/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allerg
Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingr
edient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Rel
ease [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Prote
ins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Al
t],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-me
act [EPC],Increased Histamine Release [PE],Non-Standardized Fungal Allergenic Ex
Fungal Allergenic Extract [EPC]"
ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; BE
TULA NIGRA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM AL
BUM POLLEN; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; FRAXINUS AM
ERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; KOCHIA SCOPARIA POLLEN; PLANTAGO LA
NCEOLATA POLLEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA PO
LLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; SPORISORIUM CRUENTUM; ULMUS
AMERICANA POLLEN; USTILAGO AVENAE; USTILAGO CYNODONTIS; USTILAGO MAYDIS; USTILA
GO NUDA HORDEI; USTILAGO TRITICI .002; .00013; .00013; .00013; .002; .001
; .001; .002; 16; 400; .002; .002; .002; .002; 160; .002; .002; .002; .00008; .0
mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL;
mical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histami
ne Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antige
ns, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient]
ediated Immunity [PE],Increased IgG Production [PE]"
LEN; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; PLANTAGO LANCEOLA
TA POLLEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN;
SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN .00008; .002; .0000267;
.0000267; .0000267; .00008; .00004; .00004; .00008; 16; .00008; .0004; .00008; .
0004; 160; .0004; .0004; .00008; .00008 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL
; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL
Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Rel
ONYSSINUS; FUSARIUM OXYSPORUM; GALLUS GALLUS FEATHER; PLEOSPORA HERBARUM; RHIZOP
US STOLONIFER; SPORISORIUM CRUENTUM; USTILAGO AVENAE; USTILAGO CYNODONTIS; USTIL
AGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI .00008; .00067; .00067;
10.00008; .002; .00008; .00008; .00008; .00008; 16; 16; .002; .00067; .00008; .0
mL; g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL
; g/mL; g/mL; g/mL "Standardized Insect Allergenic Extract [EPC],Increased
gredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histam
ine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [
ical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased His
tamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],A
llergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC]
,Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical
/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extr
IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Pro
teins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immuni
reased Histamine Release [PE],Non-Standardized Fungal Allergenic Extract [EPC],I
ncreased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Che
gal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immu
tion [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],
Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
IA TRIFIDA POLLEN; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; CANDIDA ALBI
CANS; CANIS LUPUS FAMILIARIS HAIR; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN
; COCHLIOBOLUS SATIVUS; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; DERMA
TOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; FRAXINUS AMERICANA POLLEN; GALLUS G
ALLUS FEATHER; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; KOCHIA
SCOPARIA POLLEN; PERIPLANETA AMERICANA; PLEOSPORA HERBARUM; POA PRATENSIS POLLEN
; RHIZOPUS STOLONIFER; RUMEX ACETOSELLA POLLEN; SORGHUM HALEPENSE POLLEN; SPORIS
ORIUM CRUENTUM; ULMUS AMERICANA POLLEN; USTILAGO CYNODONTIS .00008; .002; .0
000267; .0000267; .0000267; .00067; .00067; .002; .0004; .00004; .00004; .002; 4
00; 16; 16; 80; .0004; .00067; .002; .00008; .002; .002; .002; 160; .002; .002;
.002; .001; .0004; .001 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/
mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/
mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Non-Standardize
rs [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen
ins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insec
rgens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increas
PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/I
ngredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extrac
gG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Prote
ins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Anima
Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased
],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins
and Peptides [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [
Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Sta
EPC],Increased Histamine Release [PE]"
7; .00008; .00004; .00004; .00008; 16; .00008; .002; .00008; .00008; .00008; 160
; .00008; .00008; .002; .002; .00008; .00008 g/mL; g/mL; g/mL; g/mL; g/mL; g/
mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/
l/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine R
llergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC]"
FEATHER; ANSER ANSER FEATHER; ASPERGILLUS FUMIGATUS; CANIS LUPUS FAMILIARIS HAI
R; CLADOSPORIUM CLADOSPORIOIDES; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTER
ONYSSINUS; FUSARIUM OXYSPORUM; GALLUS GALLUS FEATHER; PERIPLANETA AMERICANA; PLE
OSPORA HERBARUM; SPORISORIUM CRUENTUM; USTILAGO CYNODONTIS .00008; .0000267
; .0000267; .00008; .002; .002; 16; 16; .002; .0000267; .00008; .002; .001; .001
g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/
mL; g/mL "Non-Standardized Feather Allergenic Extract [EPC],Increased His
tamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fe
athers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fe
munity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-S
tandardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Ce
ll-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ing
],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extrac
gG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non
-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],C
ell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemic
ungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Im
munity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient
3 "Antigen Laboratories, Inc." AMARANTHUS RETROFLEXUS POLLEN; CHENOPODI
UM ALBUM POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; IVA ANNUA VAR. ANNUA POLLEN; JU
NIPERUS VIRGINIANA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; SORGHUM
HALEPENSE POLLEN; SPORISORIUM CRUENTUM; USTILAGO CYNODONTIS .00008; .01; 400
; .00008; .002; .01; .01; .01; .001; .001 g/mL; g/mL; [AU]/mL; g/mL; g/mL;
g/mL; g/mL; g/mL; g/mL; g/mL "Non-Standardized Fungal Allergenic Extract [EPC
Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allerge
ncreased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],In
sect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standard
ediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredien
ent]"
.002; .00067; .00067; .002; .002; .002; .00008; .00008; .00008; 16; 16; 16; .000
08; .00067; .00008; .00008; .00008; .00008; .0004; .001; .0005; .001; .0005; .00
05; .0005 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; [
AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/
mL; g/mL; g/mL "Non-Standardized Feather Allergenic Extract [EPC],Increased His
tamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fe
athers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fe
munity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-S
tandardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Ce
ll-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ing
ion [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],S
tandardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE
],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ing
redient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemica
l/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histami
ne Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal
Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Ins
ncreased IgG Production [PE],Fungal Proteins [Chemical/Ingredient]"
CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; IV
A ANNUA VAR. ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; PLANTAGO LANCEOLATA POLL
EN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; SORGHUM HALEPENSE POLLEN
.00008; .002; .002; .001; .001; .002; 400; .002; .00008; .00008; .002; .002; .00
2; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/
munity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Sta
3 "Antigen Laboratories, Inc." ASPERGILLUS FUMIGATUS; CLADOSPORIUM CLAD
OSPORIOIDES; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CAT
US HAIR; RUMEX ACETOSELLA POLLEN .01; .01; 16; 16; 400; .002 g/mL; g/
mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL "Standardized Insect Allergenic Extract
s [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Alle
ediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient]
,Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingred
ient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Relea
se [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Protein
s [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen
Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [P
E],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chem
amine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredi
SIA TRIFIDA POLLEN; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; AUREOBASIDI
UM PULLULANS VAR. PULLUTANS; BETULA NIGRA POLLEN; CANDIDA ALBICANS; CANIS LUPUS
FAMILIARIS HAIR; CLADOSPORIUM CLADOSPORIOIDES; CYNODON DACTYLON POLLEN; DERMATOP
HAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; GALLUS GALLU
S FEATHER; KOCHIA SCOPARIA POLLEN; PERIPLANETA AMERICANA; PLANTAGO LANCEOLATA PO
LLEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN
.0004; .0004; .00013; .00013; .00013; .00013; .00013; .0004; .0004; .0004; .0004
; .0004; 80; 3.2; 3.2; 80; .00013; .0004; .0004; .0004; 32; .0004; .0004
g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL
; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL
ollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Ins
nity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Al
lergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],
ction [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-St
andardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cel
l-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingr
[Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased His
tamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],An
tigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredi
ent],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC
duction [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [C
hemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair
y [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemic
al/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Hista
mine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dand
er [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and P
eptides [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],I
ic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE]"
A POLLEN; BETULA NIGRA POLLEN; FRAXINUS AMERICANA POLLEN; POA PRATENSIS POLLEN;
POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; ULMUS AMERICANA POLLEN .00008;
.01; .0000267; .0000267; .0000267; .00008; .00008; 160; .002; .00008; .002
g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL "Non-Sta
nt],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE
FOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; CANDIDA ALB
ICANS; CANIS LUPUS FAMILIARIS HAIR; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLE
N; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSS
INUS; FELIS CATUS HAIR; JUNIPERUS VIRGINIANA POLLEN; POA PRATENSIS POLLEN
.005; .00013; .00013; .00013; .005; .0004; .0002; .0002; 1000; 16; 16; 400; .000
08; 10000 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/m
L; [AU]/mL; [BAU]/mL; g/mL; [BAU]/mL "Non-Standardized Pollen Allergenic Extr
[Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased His
tamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],An
tigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredi
hemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair
y [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemic
al/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Hista
mine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dand
er [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and P
eptides [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Incre
t],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Pro
[PE]"
A; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILO
STACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; BETULA NIGRA POLLEN; CARYA ALBA POLLEN;
CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN;
DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; FRAXINUS AMERICANA POLLEN; JUN
IPERUS VIRGINIANA POLLEN; KOCHIA SCOPARIA POLLEN; PLEOSPORA HERBARUM; POA PRATEN
SIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; SALSOLA KALI POLLEN;
SORGHUM HALEPENSE POLLEN; SPORISORIUM CRUENTUM; USTILAGO AVENAE; USTILAGO CYNODO
NTIS; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI .00008; .0004; .
0004; .00067; .00067; .00067; .0004; .0002; .0002; .002; 400; 400; 16; .00008; .
0004; .0004; .00008; 800; .00008; .00008; .002; .0004; .0002; .0001; .0002; .000
1; .0001; .0001 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU
]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/m
L; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Non-Standardized Pollen Allergenic Extr
munity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],
Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC]
uction [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient
hemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair All
E],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemica
l/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized
PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standa
ic Extract [EPC]"
POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA P
OLLEN; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; PLANTAGO LANCEO
LATA POLLEN; POA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN .00008; .00067;
.00067; .00067; .002; .002; 16; .00008; .002; .00008; .00008; 4000; .002
g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL;
SPORA HERBARUM; RHIZOPUS STOLONIFER; USTILAGO AVENAE; USTILAGO MAYDIS; USTILAGO
NUDA HORDEI; USTILAGO TRITICI .002; .00067; .00067; .00008; .002; .00008; .000
08; .002; .002; 400; 16; 400; .00008; .00067; .002; .00008; .002; .00008; .00008
; .00002; .00002; .00002; .00002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL
; g/mL; g/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/
mL; g/mL; g/mL; g/mL; g/mL "Non-Standardized Feather Allergenic Extract [EP
oduction [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non
Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allerge
ardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Ce
ll-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredi
ent],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/In
gredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Relea
se [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Derm
atophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allerge
],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingred
ient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract
G Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingr
edient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release
[PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermat
ophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens
[Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE]
,Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CYNODON DACTYLON POLLEN;
FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; PLANTAGO LANCEOLATA POL
LEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; SORGHU
M HALEPENSE POLLEN; ULMUS AMERICANA POLLEN .00008; .00067; .00067; .00067;
.0004; .001; .001; 16; .002; .002; .00008; 4000; .00008; .00008; .002; .002
g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; [BAU]/mL;
R. PULLUTANS; CANIS LUPUS FAMILIARIS HAIR; CLADOSPORIUM CLADOSPORIOIDES; COCHLIO
BOLUS SATIVUS; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FUSARIU
M OXYSPORUM; GALLUS GALLUS FEATHER; PERIPLANETA AMERICANA; PHOMA DESTRUCTIVA; PL
EOSPORA HERBARUM; RHIZOPUS STOLONIFER; USTILAGO AVENAE; USTILAGO MAYDIS; USTILAG
O NUDA HORDEI; USTILAGO TRITICI .00008; .0000267; .0000267; .00008; .0004; .002;
.002; .00008; 400; 16; .00008; .0000267; .002; .002; .0004; .002; .00002; .0000
2; .00002; .00002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL;
[AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Non-Sta
-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredi
ent],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract
[EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Ch
emical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Alle
],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardize
diated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [C
hemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/In
],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingred
IA TRIFIDA POLLEN; BETULA NIGRA POLLEN; CANDIDA ALBICANS; CARYA ALBA POLLEN; CAR
YA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; DERM
ATOPHAGOIDES PTERONYSSINUS; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLL
EN; JUNIPERUS VIRGINIANA POLLEN; KOCHIA SCOPARIA POLLEN; PENICILLIUM CHRYSOGENUM
VAR. CHRYSOGENUM; PHOMA DESTRUCTIVA; PLANTAGO LANCEOLATA POLLEN; PLEOSPORA HERB
ARUM; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; SALSO
LA KALI POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN .00008;
.002; .0000267; .0000267; .0000267; .00008; .002; .00004; .00004; .0004; 80; 400
; .00008; .002; .00008; .002; .0004; .00008; .0004; .00008; 160; .00008; .00008;
mL; [BAU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL;
Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Inc
on [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemic
ins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity
[PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allerg
ased Histamine Release [PE],Non-Standardized Pollen Allergenic Extract [EPC],Inc
tion [PE]"
0267; .0004; .00004; .00004; .00008; 80; .00008; .00008; .00008; .002; .002; 160
; .00008; .002; .00008; .002; .00008; .0004 g/mL; g/mL; g/mL; g/mL; g/mL; g/
[Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Aller
Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [
PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Che
A POLLEN; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; BETULA NIGRA POLLEN;
CANDIDA ALBICANS; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; DERMATOPHAG
OIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; GALLUS GALLUS F
EATHER; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; PERIPLANETA AM
ERICANA; PLANTAGO LANCEOLATA POLLEN; POA PRATENSIS POLLEN; SORGHUM HALEPENSE POL
LEN; SPORISORIUM CRUENTUM; ULMUS AMERICANA POLLEN; USTILAGO CYNODONTIS .002; .0
02; .0000267; .0000267; .0000267; .00067; .00067; .002; .00008; .002; 400; 16; 4
00; 16; .00067; .002; .00008; .002; .002; 160; .002; .001; .002; .001 g/mL; g/
mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [AU]/mL;
[BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL
ollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fun
Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [P
E],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/
Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feath
ers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feath
er Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immun
ity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Stan
t],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [
Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Sal
ivary Proteins and Peptides [Chemical/Ingredient],Standardized Pollen Allergenic
dient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release
[PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermato
phagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens
tandardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cel
l-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoide
s [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemica
l/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal P
ungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized
Pollen Allergenic Extract [EPC],Increased Histamine Release [PE]"
A POLLEN; BETULA NIGRA POLLEN; CANDIDA ALBICANS; CARYA ALBA POLLEN; CARYA ILLINO
INENSIS POLLEN; CLADOSPORIUM CLADOSPORIOIDES; CYNODON DACTYLON POLLEN; FELIS CAT
US HAIR; FRAXINUS AMERICANA POLLEN; FUSARIUM OXYSPORUM; KOCHIA SCOPARIA POLLEN;
PLEOSPORA HERBARUM; POA PRATENSIS POLLEN; QUERCUS ALBA POLLEN; SALSOLA KALI POLL
EN; SORGHUM HALEPENSE POLLEN; SPORISORIUM CRUENTUM; ULMUS AMERICANA POLLEN; USTI
LAGO AVENAE; USTILAGO CYNODONTIS; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAG
O TRITICI .002; .002; .0000267; .0000267; .0000267; .002; .00008; .001; .0
01; .002; 16; 16; .002; .002; .002; .00008; 160; .002; .002; .00008; .001; .002;
; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL;
mical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased His
tamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fu
ngal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standard
,Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [
stamine Release [PE],Cell-mediated Immunity [PE]"
FEATHER; ANSER ANSER FEATHER; ASPERGILLUS FUMIGATUS; CLADOSPORIUM CLADOSPORIOID
ES; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR;
GALLUS GALLUS FEATHER; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; SPORISORIUM CRU
ENTUM; USTILAGO CYNODONTIS .0004; .00067; .00067; .002; .002; 80; 80; 80; .
00067; .002; .001; .001 g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; [BAU]/mL
; g/mL; g/mL; g/mL; g/mL "Non-Standardized Fungal Allergenic Extract [EPC
ical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased His
tamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],A
llergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC]
,Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical
l Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized An
l Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized In
],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [C
267; .00008; .00004; .00004; .002; 16; .00008; .0004; .00008; .002; .00008; 160;
.00008; .00008; .002; .002; .0004; .00008 g/mL; g/mL; g/mL; g/mL; g/mL; g/
l/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Imm
unity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased
Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen A
ity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standa
FEATHER; ASPERGILLUS FUMIGATUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; CANDIDA
ALBICANS; CLADOSPORIUM CLADOSPORIOIDES; COCHLIOBOLUS SATIVUS; DERMATOPHAGOIDES F
ARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FUSARIUM OXYSPORUM; GALLUS GALLUS FEATHE
R; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PERIPLANETA AMERICANA; PHOMA DESTRU
CTIVA; PLEOSPORA HERBARUM; RHIZOPUS STOLONIFER; SPORISORIUM CRUENTUM; USTILAGO A
VENAE; USTILAGO CYNODONTIS; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRIT
ICI .00067; .00067; .002; .002; .002; .002; .002; 400; 16; .002; .00067; .00
2; .002; .002; .002; .002; .001; .0005; .001; .0005; .0005; .0005 g/mL; g/
mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL
; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Non-Standardized Fungal
G Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient]
,Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [
PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemic
al/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Hista
mine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],All
redient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Releas
redient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Re
eins [Chemical/Ingredient]"
A ANNUA VAR. ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; POPULUS DELTOIDES POLLEN
; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN .002; .0
0008; .002; .001; .001; .002; 400; .002; .0004; .002; .002; .002; .002; .002
g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL
; g/mL "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Re
nt],Increased Histamine Release [PE],Allergens [Chemical/Ingredient]"
3 "Antigen Laboratories, Inc." CANDIDA ALBICANS; COCHLIOBOLUS SATIVUS;
DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FRAXINUS AMERICANA POL
LEN; IVA ANNUA VAR. ANNUA POLLEN; PERIPLANETA AMERICANA; SALSOLA KALI POLLEN
.01; .01; 1000; 1000; .01; .01; .01; .01 g/mL; g/mL; [AU]/mL; [AU]/mL; g/
mL; g/mL; g/mL; g/mL "Non-Standardized Fungal Allergenic Extract [EPC],Increa
nt],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [
Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingred
ient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG
se [PE]"
ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; AU
REOBASIDIUM PULLULANS VAR. PULLUTANS; BETULA NIGRA POLLEN; CANIS LUPUS FAMILIARI
S HAIR; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN;
CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; JUNIPERUS VIRGINIANA POLLEN
; KOCHIA SCOPARIA POLLEN; PERIPLANETA AMERICANA; PHOMA DESTRUCTIVA; PLANTAGO LAN
CEOLATA POLLEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POL
LEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN .002; .000027; .000027;
.000027; .002; .00008; .002; .00004; .00004; .002; 16; .00008; .00008; .002; .00
2; .002; .002; 160; .00008; .00008; .002; .00008 g/mL; g/mL; g/mL; g/mL;
; [BAU]/mL; g/mL; g/mL; g/mL; g/mL "Standardized Pollen Allergenic Extract
mical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increase
E],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized In
unity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],A
mical/Ingredient]"
XUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; CANIS LUPUS FAMILIARIS HAIR; CARYA A
LBA POLLEN; CARYA ILLINOINENSIS POLLEN; CYNODON DACTYLON POLLEN; FELIS CATUS HAI
R; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; JUGLANS NIGRA POLLEN;
JUNIPERUS ASHEI POLLEN; MORUS ALBA POLLEN; PHLEUM PRATENSE POLLEN; PLATANUS OCC
IDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELL
A POLLEN; SALSOLA KALI POLLEN; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN
.0000666; .00033; 5.33; .0008333; .0000333; .0000333; 13.3333; 33.33; .0000133;
.0000666; .0000666; .0000666; .00833; 666.67; .0000666; .0000666; .0000666; .000
0666; .0000666; .0000666; .0003333 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL
g/mL "Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity
mine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allerg
ngredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine
Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [
Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Pepti
des [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],
ction [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standar
ated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],
PE],Cell-mediated Immunity [PE],Increased IgG Production [PE]"
49288-0774_93e07e85-ef26-4a23-a178-148bbd9369e2 49288-0774 HUMAN PRESCRIPTI
LEPENSE POLLEN .00008; .0004; .00002666; .00002666; .00002666; .00008; .00004;
.00004; .0004; 16; .0004; .0004; .002; .002; .00008; 160; .002; .0004; .00008; .
002; .00008 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL;
g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Standar
Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ing
stamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Al
ardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE]"
49288-0775_93e07e85-ef26-4a23-a178-148bbd9369e2 49288-0775 HUMAN PRESCRIPTI
FEATHER; ASPERGILLUS FUMIGATUS; CANIS LUPUS FAMILIARIS HAIR; CLADOSPORIUM CLADOS
PORIOIDES; COCHLIOBOLUS SATIVUS; DERMATOPHAGOIDES PTERONYSSINUS; FUSARIUM OXYSPO
RUM; GALLUS GALLUS FEATHER; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PERIPLANET
A AMERICANA; PHOMA DESTRUCTIVA; PLEOSPORA HERBARUM; RHIZOPUS STOLONIFER .0000266
6; .00002666; .00008; .00008; .0004; .0004; 16; .0004; .00002666; .0004; .00008;
.0004; .002; .00008 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL;
g/mL; g/mL; g/mL; g/mL; g/mL "Non-Standardized Animal Hair Allergenic Extract
G Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-
ll-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemica
l/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergeni
reased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/In
gredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine
Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergen
s [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increa
sed Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingred
49288-0776_620f9cd6-e5b8-4036-a2dd-388186abade3 49288-0776 HUMAN PRESCRIPTI
CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; JUNIPERUS VIRGINIANA POLLEN;
PLANTAGO LANCEOLATA POLLEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; QUE
RCUS ALBA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA
POLLEN .000067; .0000133; .0000133; .000033; .000033; 13.33; .0000133; .00033;
.000067; 26.67; .0000133; .0000133; .000067; .000067; .000067 g/mL; g/mL; g/mL
; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL
mical/Ingredient]"
49288-0777_769ae8c8-2f24-4e91-a9ae-4baf91c5a756 49288-0777 HUMAN PRESCRIPTI
FEATHER; ANSER ANSER FEATHER; ASPERGILLUS FUMIGATUS; CANDIDA ALBICANS; CANIS LU
PUS FAMILIARIS HAIR; CLADOSPORIUM CLADOSPORIOIDES; COCHLIOBOLUS SATIVUS; DERMATO
PHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FUSARIUM OXYSPORUM; GALLUS GA
LLUS FEATHER; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PERIPLANETA AMERICANA; P
HOMA DESTRUCTIVA; PLEOSPORA HERBARUM; RHIZOPUS STOLONIFER; SPORISORIUM CRUENTUM;
USTILAGO AVENAE; USTILAGO CYNODONTIS; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; US
TILAGO TRITICI .002; .000027; .000027; .002; .0004; .002; .002; .002; 16; 16; .
002; .000027; .002; .0004; .002; .00008; .002; .00004; .0005; .00004; .0005; .00
05; .0005 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL
; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL
ion [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],N
on-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE
],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/I
ty [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardi
zed Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediat
ed Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemi
cal/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingred
ient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins
lergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Fungal
s [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal
A ANNUA VAR. ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; KOCHIA SCOPARIA POLLEN;
PLANTAGO LANCEOLATA POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX
ACETOSELLA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN .00008;
.00008; .00008; .001; .001; .0004; 16; .002; .00008; .0004; .0004; .00008; .002;
.002; .002; .0004; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/
mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Non-Standardize
n-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Incre
ased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Releas
e [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [E
edient]"
CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; JU
NIPERUS VIRGINIANA POLLEN; PLANTAGO LANCEOLATA POLLEN; POA PRATENSIS POLLEN; POP
ULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPEN
SE POLLEN; ULMUS AMERICANA POLLEN .002; .002; .002; .001; .001; .002; 400;
.002; .002; .002; 4000; .002; .002; .002; .002; .002 g/mL; g/mL; g/mL; g/mL;
g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL
49288-0780_52150fa7-4a21-4e92-8659-4277b21eff92 49288-0780 HUMAN PRESCRIPTI
XUS POLLEN; BETULA NIGRA POLLEN; CANIS LUPUS FAMILIARIS HAIR; CARYA ALBA POLLEN;
CARYA ILLINOINENSIS POLLEN; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE;
DERMATOPHAGOIDES PTERONYSSINUS; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA
POLLEN; JUNIPERUS VIRGINIANA POLLEN; KOCHIA SCOPARIA POLLEN; PERIPLANETA AMERICA
NA; PLEOSPORA HERBARUM; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACE
TOSELLA POLLEN; SORGHUM HALEPENSE POLLEN; SPORISORIUM CRUENTUM; USTILAGO AVENAE;
USTILAGO CYNODONTIS; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI
.00008; .00008; .002; .00008; .0002; .0002; 400; 400; 16; .002; .002; .00008; .0
0008; .00008; .00008; .00008; .002; .00008; .00008; .00004; .00002; .00004; .000
02; .00002; .00002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [
AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL;
g/mL; g/mL; g/mL; g/mL "Standardized Insect Allergenic Extract [EPC],Increased
edient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic
t],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release
[PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [
nt]"
49288-0781_52150fa7-4a21-4e92-8659-4277b21eff92 49288-0781 HUMAN PRESCRIPTI
3 "Antigen Laboratories, Inc." CYNODON DACTYLON POLLEN; PHLEUM PRATENSE
POLLEN 2000; 20000 [BAU]/mL; [BAU]/mL "Standardized Pollen Allergenic
49288-0782_7653a564-fc76-4deb-bab0-0897c1851350 49288-0782 HUMAN PRESCRIPTI
STACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER
FEATHER; BETULA NIGRA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CY
NODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; FRAXINUS AMERICANA POLLEN; GALL
US GALLUS FEATHER; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; KOC
HIA SCOPARIA POLLEN; PERIPLANETA AMERICANA; PLEOSPORA HERBARUM; POA PRATENSIS PO
LLEN; QUERCUS ALBA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; SPORIS
ORIUM CRUENTUM; USTILAGO AVENAE; USTILAGO CYNODONTIS; USTILAGO MAYDIS; USTILAGO
NUDA HORDEI; USTILAGO TRITICI .00008; .00008; .002; .0000266; .0000266; .00002
66; .0006666; .0006666; .00008; .00002; .00002; 400; 16; .00008; .0006666; .004;
.00008; .00008; .0004; .00008; 160; .00008; .002; .00008; .00004; .0005; .00004
; .0005; .0005; .0005 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/
mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/m
L; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Standardized Pollen All
len [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insec
rgens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],In
ion [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Stan
dardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-
mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingred
ient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Rele
ase [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [C
49288-0783_7653a564-fc76-4deb-bab0-0897c1851350 49288-0783 HUMAN PRESCRIPTI
HYNCHOS FEATHER; ANSER ANSER FEATHER; CANDIDA ALBICANS; CANIS LUPUS FAMILIARIS H
AIR; CLADOSPORIUM CLADOSPORIOIDES; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FAR
INAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; FRAXINUS AMERICANA POLLE
N; GALLUS GALLUS FEATHER; JUNIPERUS VIRGINIANA POLLEN; PENICILLIUM CHRYSOGENUM V
AR. CHRYSOGENUM; PERIPLANETA AMERICANA; PLANTAGO LANCEOLATA POLLEN; PLEOSPORA HE
RBARUM; POA PRATENSIS POLLEN; RHIZOPUS STOLONIFER; ULMUS AMERICANA POLLEN
.00008; .0000266; .0000266; .0000266; .0006666; .0006666; .00008; .0004; .002; 4
00; 80; 400; 16; .00008; .0006666; .0004; .002; .0004; .00008; .002; 160; .002;
.002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL;
[AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/
mL "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Re
edient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extr
IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient
],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Pollen Aller
Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Rel
ease [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, De
rmatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Aller
[EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chem
se [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chem
ical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased
],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Ins
nity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Al
lergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],
Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/
ased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingr
llen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect A
[PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredie
nt],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-St
andardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE]"
49288-0784_84a6e36f-24af-40ed-8dd9-114b1108ccf3 49288-0784 HUMAN PRESCRIPTI
HAIR; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CLADOSPORIUM HERBARUM; DER
MATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; FRAXINU
S AMERICANA POLLEN; JUGLANS NIGRA POLLEN; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGEN
UM; QUERCUS ALBA POLLEN; SALSOLA KALI POLLEN .002; .002; 4000; .002; .002; .0
01; .001; .002; 400; 400; 400; .002; .002; .002; .002; .002 g/mL; g/mL; [AU]
/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL;
g/mL; g/mL "Standardized Insect Allergenic Extract [EPC],Increased Histamin
ns [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hai
emical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Stan
ell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredien
49288-0785_84a6e36f-24af-40ed-8dd9-114b1108ccf3 49288-0785 HUMAN PRESCRIPTI
SIA TRIFIDA POLLEN; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; AUREOBASIDI
UM PULLULANS VAR. PULLUTANS; BETULA NIGRA POLLEN; CANIS LUPUS FAMILIARIS HAIR; C
ARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; DERMATOP
HAGOIDES PTERONYSSINUS; GALLUS GALLUS FEATHER; IVA ANNUA VAR. ANNUA POLLEN; JUNI
PERUS VIRGINIANA POLLEN; KOCHIA SCOPARIA POLLEN; PERIPLANETA AMERICANA; PHOMA DE
STRUCTIVA; PLEOSPORA HERBARUM; QUERCUS ALBA POLLEN; RHIZOPUS STOLONIFER; SALSOLA
KALI POLLEN; SORGHUM HALEPENSE POLLEN; USTILAGO AVENAE; USTILAGO MAYDIS; USTILA
GO NUDA HORDEI; USTILAGO TRITICI .002; .0004; .0006666; .0006666; .000666
6; .000667; .000667; .002; .002; .00008; .001; .001; .00008; 400; .000667; .0000
8; .002; .00008; .00008; .002; .002; .002; .002; .00008; .00008; .0002; .0002; .
00002; .00002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL
; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/m
L; g/mL; g/mL; g/mL; g/mL; g/mL "Non-Standardized Fungal Allergenic Extract [EPC
,Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized F
eather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated I
mmunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-
Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],C
ell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingr
edient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extr
act [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers
[Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Ha
ir Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immun
ity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chem
ical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Hist
ect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized
Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated I
mmunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/
Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient
cal/Ingredient]"
49288-0786_51d18fca-e7c9-4032-8120-be71ed6e2a7f 49288-0786 HUMAN PRESCRIPTI
STACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; BETULA NIGRA POLLEN; CARYA ALBA POLLEN;
CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN;
DERMATOPHAGOIDES PTERONYSSINUS; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA
POLLEN; JUNIPERUS VIRGINIANA POLLEN; KOCHIA SCOPARIA POLLEN; PLANTAGO LANCEOLATA
POLLEN; PLEOSPORA HERBARUM; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; QUE
E POLLEN; SPORISORIUM CRUENTUM; ULMUS AMERICANA POLLEN; USTILAGO AVENAE; USTILAG
O CYNODONTIS; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI .0008; .
002; .00008; .0000266; .0000266; .0000266; .00008; .00004; .00004; .00008; 16; 4
00; .00008; .00008; .00008; .00008; .00008; .00008; 160; .00008; .00008; .00008;
.00008; .00008; .0002; .002; .00002; .0002; .00002; .00002; .00002 g/mL; g/
mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; g/mL; g/m
L; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g
/mL; g/mL; g/mL; g/mL; g/mL "Non-Standardized Fungal Allergenic Extract [EPC
,Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insec
ty [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingre
dient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non
ins [Chemical/Ingredient]"
49288-0787_b4053499-e3af-4991-9c56-5eb96ac94dca 49288-0787 HUMAN PRESCRIPTI
FOLIA POLLEN; CANIS LUPUS FAMILIARIS HAIR; FELIS CATUS HAIR; PHLEUM PRATENSE POL
LEN .002; 4000; .002; 400; 4000 g/mL; [AU]/mL; g/mL; [BAU]/mL; [BAU]/mL
"Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Relea
edient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Re
lease [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Che
mical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides
3 "Antigen Laboratories, Inc." CANIS LUPUS FAMILIARIS HAIR; CYNODON DAC
TYLON POLLEN; DACTYLIS GLOMERATA POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOI
DES PTERONYSSINUS; FELIS CATUS HAIR; LOLIUM PERENNE POLLEN; PASPALUM NOTATUM POL
LEN; PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN; RHIZOPUS STOLONIFER; SORGHUM
HALEPENSE POLLEN .005; 80; 4000; 1000; 1000; 400; 160; .0004; 800; 800; .
005; .0004 g/mL; [BAU]/mL; [BAU]/mL; [AU]/mL; [AU]/mL; [BAU]/mL; [BAU]/mL;
g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL "Standardized Animal Hair Allergenic Ext
al/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine
Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens,
Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Al
lergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Incre
[PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical
al/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine
3 "Antigen Laboratories, Inc." ACER RUBRUM POLLEN; AMARANTHUS RETROFLEX
US POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; BETULA POPULIFOLIA POLLEN; CARYA ILLI
NOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; FRAXINUS AMERICANA POLLEN; IVA ANNUA
VAR. ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; PLANTAGO LANCEOLATA POLLEN; POP
ULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KAL
I POLLEN; ULMUS AMERICANA POLLEN .0004; .0004; 20000; .000016; .000016; .
002; .0004; .01; .00008; .0004; .00008; .0004; .002; .0004; .0004 g/mL; g/
mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g
/mL "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Re
dized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG
Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Al
49288-0790_2fc9a4e3-a3ca-4795-91c7-95f1061f4ae0 49288-0790 HUMAN PRESCRIPTI
EXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; ASPERGILLUS FUMIGATUS; CANIS LUPUS
FAMILIARIS HAIR; CLADOSPORIUM HERBARUM; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOID
ES PTERONYSSINUS; FELIS CATUS HAIR; IVA ANNUA VAR. ANNUA POLLEN; PENICILLIUM CHR
YSOGENUM VAR. CHRYSOGENUM; PERIPLANETA AMERICANA; QUERCUS ALBA POLLEN; URTICA DI
OICA POLLEN .002; .002; 4000; .002; .002; .002; 400; 400; 400; .002; .002; .
002; .002; .002 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; [BAU]/m
L; g/mL; g/mL; g/mL; g/mL; g/mL "Standardized Insect Allergenic Extract [EPC],In
[PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens
E],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standar
emical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Aller
,Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [
nity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Stand
49288-0791_2fc9a4e3-a3ca-4795-91c7-95f1061f4ae0 49288-0791 HUMAN PRESCRIPTI
IA TRIFIDA POLLEN; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; BETULA NIGRA
POLLEN; CANDIDA ALBICANS; CANIS LUPUS FAMILIARIS HAIR; CARYA ALBA POLLEN; CARYA
ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; DERMATOPHAGOIDES FARINAE; FRAXI
NUS AMERICANA POLLEN; GALLUS GALLUS FEATHER; IVA ANNUA VAR. ANNUA POLLEN; JUNIPE
RUS VIRGINIANA POLLEN; PLANTAGO LANCEOLATA POLLEN; PLEOSPORA HERBARUM; POPULUS D
ELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLL
EN; USTILAGO AVENAE; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI
.0004; .002; .00067; .00067; .00067; .00067; .00067; .00008; .002; .002; .00004;
.00004; .002; 80; .00008; .00067; .002; .002; .002; .0004; .00008; .00008; .002
; .002; .00002; .00002; .00002; .00002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL
; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/m
L; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Non-Standardized Animal
hemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Hista
mine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Anti
gens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredien
l/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histam
ine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feath
49288-0792_d7b4b93b-b9fc-4188-a1ab-b905d286e2ee 49288-0792 HUMAN PRESCRIPTI
3 "Antigen Laboratories, Inc." DERMATOPHAGOIDES PTERONYSSINUS; QUERCUS
ALBA POLLEN 2000; .01 [AU]/mL; g/mL "Standardized Insect Allergenic
LEN; CLADOSPORIUM HERBARUM; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; D
ERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; FRAXINUS AMERICANA POLLEN; IVA
ANNUA VAR. ANNUA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS ASHEI POLLEN; PHLEUM PR
ATENSE POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS A
LBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; ULMUS AMERICANA POLLEN
; URTICA DIOICA POLLEN .0016666; .0008333; .0016666; 666.667; .0008333; .000033
3; .0008333; .0008333; .0008333; 333.333; 166.667; 166.667; 33.333; .0003333; .0
003333; .0016666; .0016666; 666.667; .0016666; .0016666; .0016666; .0016666; .00
16666; .0016666; .0016666 g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/m
L; g/mL; [BAU]/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL;
g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Standardized Insect Allergenic
nic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],F
dient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extra
IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient]
,Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Ha
ity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chem
zed Pollen Allergenic Extract [EPC]"
XUS POLLEN; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; BETULA NIGRA POLLEN
; CANDIDA ALBICANS; CANIS LUPUS FAMILIARIS HAIR; CLADOSPORIUM CLADOSPORIOIDES; C
OCHLIOBOLUS SATIVUS; DERMATOPHAGOIDES FARINAE; FELIS CATUS HAIR; FRAXINUS AMERIC
ANA POLLEN; FUSARIUM OXYSPORUM; GALLUS GALLUS FEATHER; IVA ANNUA VAR. ANNUA POLL
EN; JUNIPERUS VIRGINIANA POLLEN; PLEOSPORA HERBARUM; POA PRATENSIS POLLEN; RHIZO
PUS STOLONIFER .002; .005; .0006666; .0006666; .002; .005; .002; .002; .002; 40
0; 16; .005; .002; .0006666; .00008; .002; .005; 4000; .005 g/mL; g/mL; g/mL
; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL;
g/mL; g/mL; [BAU]/mL; g/mL "Cell-mediated Immunity [PE],Increased IgG Produ
E],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release
ty [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardize
iated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],A
llergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredie
redient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract
s [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal
emical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased H
Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized
Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non
ngredient]"
49288-0795_dea14126-aacc-4f9f-81fe-9bf179310483 49288-0795 HUMAN PRESCRIPTI
3 "Antigen Laboratories, Inc." AMBROSIA ARTEMISIIFOLIA POLLEN; CYNODON
DACTYLON POLLEN; FELIS CATUS HAIR; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANN
UA POLLEN; PHLEUM PRATENSE POLLEN 10000; 2000; 2000; .005; .05; 20000
[AU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL "Standardized Animal Hai
emical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standard
A POLLEN; BETULA NIGRA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; DE
RMATOPHAGOIDES FARINAE; FRAXINUS AMERICANA POLLEN; JUNIPERUS VIRGINIANA POLLEN;
KOCHIA SCOPARIA POLLEN; PLEOSPORA HERBARUM; POA PRATENSIS POLLEN; QUERCUS ALBA P
OLLEN; SORGHUM HALEPENSE POLLEN; SPORISORIUM CRUENTUM; USTILAGO CYNODONTIS
.000016; .000016; .0000053; .0000053; .0000053; .000016; .000008; .000008; 3.2;
.000016; .000016; .000016; .000016; 32; .000016; .000016; .000008; .000008
g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL;
[BAU]/mL; g/mL; g/mL; g/mL; g/mL "Non-Standardized Pollen Allergenic Extr
t],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE]
,Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophag
oides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Che
"
3 "Antigen Laboratories, Inc." AMARANTHUS RETROFLEXUS POLLEN; ANAS PLAT
YRHYNCHOS FEATHER; ANSER ANSER FEATHER; CYNODON DACTYLON POLLEN; GALLUS GALLUS F
EATHER; IVA ANNUA VAR. ANNUA POLLEN; PERIPLANETA AMERICANA; SALSOLA KALI POLLEN;
USTILAGO AVENAE; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI
.0004; .00013; .00013; 80; .00013; .00008; .00008; .0004; .0001; .0001; .0001; .
0001 g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/
mL "Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine R
PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardi
zed Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-media
ted Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient]
n-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],
Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemi
FEATHER; ASPERGILLUS FUMIGATUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; CANIS LU
PHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FUSARIUM OXYSPORUM; GALLUS GA
LLUS FEATHER; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PERIPLANETA AMERICANA; P
HOMA DESTRUCTIVA; USTILAGO AVENAE; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILA
GO TRITICI .0000266; .00000266; .002; .01; .00008; .00008; .00008; 16; 16;
.002; .0000266; .00008; .00008; .002; .0005; .0005; .0005; .0005 g/mL; g/
mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL
; g/mL; g/mL; g/mL; g/mL "Non-Standardized Animal Hair Allergenic Extract
G Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Stan
ediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [
Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/I
d Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredie
nt],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract
Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],
E],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemica
ine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Alle
ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; BE
TULA NIGRA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM AL
BUM POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. A
NNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA
POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN;
ULMUS AMERICANA POLLEN .002; .0000266; .0000266; .0000266; .00008; .0004; .0004
; .01; 80; .0004; .01; .002; .00008; .00008; .002; .002; .002; .002 g/mL; g/
mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL;
Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens
Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Produ
ction [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allerge
49288-0800_546445e5-abf0-45e0-99fc-859dccb66062 49288-0800 HUMAN PRESCRIPTI
TUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; CANIS LUPUS FAMILIARIS HAIR; CLADOS
PORIUM CLADOSPORIOIDES; COCHLIOBOLUS SATIVUS; FELIS CATUS HAIR; PERIPLANETA AMER
ICANA; PHOMA DESTRUCTIVA; PLEOSPORA HERBARUM; RHIZOPUS STOLONIFER; USTILAGO AVEN
AE; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI .00008; .00008;
.00008; .00008; .0004; .0004; 16; .0008; .00008; .00008; .00008; .00002; .00002;
.00002; .00002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL;
g/mL; g/mL; g/mL; g/mL; g/mL "Standardized Animal Hair Allergenic Extract [EP
ary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Fungal Allergen
mical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increase
E],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized In
Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Ch
,Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
49288-0801_546445e5-abf0-45e0-99fc-859dccb66062 49288-0801 HUMAN PRESCRIPTI
OLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA
POLLEN; JUNIPERUS VIRGINIANA POLLEN; PLANTAGO LANCEOLATA POLLEN; POA PRATENSIS P
OLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; S
ALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN .00008;
.00008; .00067; .00067; .00067; .00008; .00004; .00004; 400; .00008; .00008; .00
2; .0004; 160; .00008; .00008; .00008; .0004; .00008; .0004 g/mL; g/mL; g/mL
; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL
; g/mL; g/mL; g/mL; g/mL; g/mL "Standardized Pollen Allergenic Extract [EPC],In
rdized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG
Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],A
49288-0802_604c0704-1a4c-431a-9876-de77f5f3882c 49288-0802 HUMAN PRESCRIPTI
3 "Antigen Laboratories, Inc." AMBROSIA ARTEMISIIFOLIA POLLEN; BETULA P
OPULIFOLIA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CYNODON DACTYL
ON POLLEN; FELIS CATUS HAIR; FESTUCA PRATENSIS POLLEN; PASPALUM NOTATUM POLLEN;
PLANTAGO LANCEOLATA POLLEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; SORG
HUM HALEPENSE POLLEN 800; .002; .002; .002; 400; 16; 4000; .002; .002; 4000;
.002; .002 [AU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g
/mL; [BAU]/mL; g/mL; g/mL "Standardized Animal Hair Allergenic Extract [EP
ary Proteins and Peptides [Chemical/Ingredient],Standardized Pollen Allergenic E
t]"
FOLIA POLLEN; CANIS LUPUS FAMILIARIS HAIR; FELIS CATUS HAIR; IVA ANNUA VAR. ANNU
A POLLEN; JUNIPERUS ASHEI POLLEN .002; 4000; .002; 400; .002; .002
g/mL; [AU]/mL; g/mL; [BAU]/mL; g/mL; g/mL "Non-Standardized Fungal Allerge
emical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased H
Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins a
nd Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extrac
OLIA POLLEN; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES
PTERONYSSINUS; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS ASHEI POLLEN; PHLEUM PRAT
ENSE POLLEN; ULMUS AMERICANA POLLEN .005; 10000; 1000; 400; 400; .005; .002;
4000; .005 g/mL; [AU]/mL; [BAU]/mL; [AU]/mL; [AU]/mL; g/mL; g/mL; [BAU]/mL;
g/mL "Standardized Insect Allergenic Extract [EPC],Increased Histamine Releas
ONYSSINUS; FELIS CATUS HAIR; GALLUS GALLUS FEATHER; PENICILLIUM CHRYSOGENUM VAR.
CHRYSOGENUM; PERIPLANETA AMERICANA; PHOMA DESTRUCTIVA; PLEOSPORA HERBARUM; RHIZ
OPUS STOLONIFER; SPORISORIUM CRUENTUM; USTILAGO AVENAE; USTILAGO CYNODONTIS; UST
ILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI .00008; .0006666; .00066
66; .00008; .00008; .00008; .002; .002; .01; 16; 16; 16; .0006666; .002; .00008;
.002; .002; .00008; .0002; .0005; .0002; .0005; .0005; .0005 g/mL; g/mL; g/mL
; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/
mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Standardized An
rgens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Inc
on [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],St
e Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient]
[Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE]
ardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Sta
d Histamine Release [PE],Cell-mediated Immunity [PE]"
N; QUERCUS ALBA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AME
RICANA POLLEN .002; .002; .0000266; .0000266; .0000266; .002; .001; .001; .000
4; 16; .002; .002; .00008; .00008; .00008; 160; .00008; .002; .0004; .00008; .00
04 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/
mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Standardized Po
ed Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],St
Pollen Allergenic Extract [EPC]"
49288-0807_ae8520ee-f4a4-4de4-9d2d-bccc97d30931 49288-0807 HUMAN PRESCRIPTI
PUS FAMILIARIS HAIR; CARYA ALBA POLLEN; CARYA TOMENTOSA POLLEN; CYNODON DACTYLON
POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS H
AIR; IVA ANNUA VAR. ANNUA POLLEN; JUGLANS NIGRA POLLEN; PHLEUM PRATENSE POLLEN;
ULMUS AMERICANA POLLEN 10000; .002; .0025; .0025; 1000; 400; 400; 400; .005; .0
05; 4000; .005 [AU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [AU]/mL; [BAU]/mL;
g/mL; g/mL; [BAU]/mL; g/mL "Standardized Animal Hair Allergenic Extract [EP
t],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE]
,Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophag
oides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Che
mical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histami
ne Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antige
ns, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient]
,Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract
G Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-
3 "Antigen Laboratories, Inc." CARYA ILLINOINENSIS POLLEN; CARYA TOMENT
OSA POLLEN; JUGLANS NIGRA POLLEN; PLATANUS OCCIDENTALIS POLLEN; SALSOLA KALI POL
LEN; ULMUS AMERICANA POLLEN .0002; .0002; .002; .01; .01; .01 g/mL; g/
FEATHER; ANSER ANSER FEATHER; ASPERGILLUS FUMIGATUS; CANDIDA ALBICANS; CANIS LU
PHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; GALLUS GALLUS FEATHER; PENICI
LLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PERIPLANETA AMERICANA; PLEOSPORA HERBARUM; R
HIZOPUS STOLONIFER; USTILAGO AVENAE; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTI
LAGO TRITICI .00008; .00067; .00067; .002; .002; .00008; .00008; .002; 16; 16
; .00067; .00008; .00008; .00008; .00008; .00002; .00002; .00002; .00002
g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; g/mL; g/mL; g/
mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Standardized Insect Allergenic Extract
[PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell
xtract [EPC],Increased Histamine Release [PE],Non-Standardized Insect Allergenic
eased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemi
cal/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Hist
amine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fea
thers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fea
ther Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Imm
unity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-St
andardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cel
l-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingr
ins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Anima
,Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardi
ient]"
IA TRIFIDA POLLEN; BETULA NIGRA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA TOMENT
OSA POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERICAN
A POLLEN; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; KOCHIA SCOPA
RIA POLLEN; PLANTAGO LANCEOLATA POLLEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES
POLLEN; QUERCUS ALBA POLLEN; SORGHUM HALEPENSE POLLEN .00008; .002; .00008; .0
0008; .00008; .0004; .00004; .00004; .002; 16; .00008; .002; .002; .002; .002; 4
00; .00008; .0004; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [B
AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL "Standar
49288-0811_2413d900-60a6-4cfd-99b2-0ceccd0d1249 49288-0811 HUMAN PRESCRIPTI
3 "Antigen Laboratories, Inc." AMARANTHUS RETROFLEXUS POLLEN; CARYA ILL
INOINENSIS POLLEN; CARYA TOMENTOSA POLLEN; CYNODON DACTYLON POLLEN; DERMATOPHAGO
IDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; JUGLANS NIGRA POLLEN; PERIPLANETA
AMERICANA; PHLEUM PRATENSE POLLEN .002; .001; .001; 400; 400; 400; .002; .
002; 4000 g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [AU]/mL; g/mL; g/mL; g/mL
49288-0812_2413d900-60a6-4cfd-99b2-0ceccd0d1249 49288-0812 HUMAN PRESCRIPTI
LEN; ACER SACCHARUM POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOL
IA POLLEN; AMBROSIA TRIFIDA POLLEN; BETULA ALLEGHANIENSIS POLLEN; BETULA LENTA P
OLLEN; BETULA NIGRA POLLEN; BETULA OCCIDENTALIS POLLEN; BETULA PAPYRIFERA POLLEN
; BETULA POPULIFOLIA POLLEN; CANIS LUPUS FAMILIARIS HAIR; CHENOPODIUM ALBUM POLL
EN; FELIS CATUS HAIR; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; HOUSE
DUST; IVA ANNUA VAR. ANNUA POLLEN; IVA XANTHIFOLIA POLLEN; JUGLANS NIGRA POLLEN
; KOCHIA SCOPARIA POLLEN; LOLIUM PERENNE POLLEN; PLANTAGO LANCEOLATA POLLEN; PLA
TANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; QUERCU
S RUBRA POLLEN; QUERCUS VIRGINIANA POLLEN; RUMEX ACETOSELLA POLLEN; RUMEX CRISPU
S POLLEN; SALSOLA KALI POLLEN; ULMUS AMERICANA POLLEN .0008; .0008; .0008; .00
24; .0012; .0012; .0004; .0004; .0004; .0004; .0004; .0004; .0024; .0024; 476.19
; 4761.9; .0024; .0024; .0012; .0012; .0024; .0024; 4761.9; .0024; .0024; .0024;
.0008; .0008; .0008; .0012; .0012; .0024; .0024 g/mL; g/mL; g/mL; g/mL;
g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL;
; g/mL; g/mL; g/mL; g/mL "Standardized Pollen Allergenic Extract [EPC],In
Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/In
gredient],Allergens [Chemical/Ingredient],Non-Standardized House Dust Allergenic
eased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/I
ction [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardize
tract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Ch
emical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredie
/Ingredient]"
49288-0813_059e23cb-ae1d-4fe5-9496-93f48225effd 49288-0813 HUMAN PRESCRIPTI
3 "Antigen Laboratories, Inc." CANIS LUPUS FAMILIARIS HAIR 0.002
g/mL "Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histami
XUS POLLEN; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; BASSIA SCOPARIA POLLEN; CAND
IDA ALBICANS; CARYA ILLINOINENSIS POLLEN; CARYA TOMENTOSA POLLEN; CHENOPODIUM AL
BUM POLLEN; CLADOSPORIUM CLADOSPORIOIDES; COCHLIOBOLUS SATIVUS; DERMATOPHAGOIDES
FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; IVA ANNUA POLLEN; JU
NIPERUS VIRGINIANA POLLEN; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PHOMA DESTR
UCTIVA; POPULUS DELTOIDES POLLEN; RHIZOPUS STOLONIFER; SALSOLA KALI POLLEN; SORG
HUM HALEPENSE POLLEN; SPORISORIUM CRUENTUM; ULMUS AMERICANA POLLEN; USTILAGO CYN
ODONTIS .002; .002; .002; .002; .00008; .001; .001; .002; .002; .002; 16; 400; 1
6; .002; .00008; .0004; .002; .002; .002; .002; .002; .001; .00008; .001
g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; [B
AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL
],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Anim
ns [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],St
cal/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Incr
mine Release [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased His
ngal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
A; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; CARYA TOMENTOS
A POLLEN; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PT
ERONYSSINUS; MORUS ALBA POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALI
S POLLEN; POA PRATENSIS POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; SP
ORISORIUM CRUENTUM; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN .002; .0
02; .002; 4000; .002; 80; 400; 400; .002; .002; .002; 32; .002; .002; .0004; .00
2; .002 g/mL; g/mL; g/mL; [AU]/mL; g/mL; [BAU]/mL; [AU]/mL; [AU]/mL; g/mL; g/mL;
g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Non-Standardized Fungal Allerge
n [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Alle
nt],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standar
XUS POLLEN; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; ASPERGILLUS FUMIGAT
US; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; BETULA NIGRA POLLEN; CANDIDA ALBICAN
S; CANIS LUPUS FAMILIARIS HAIR; CARYA ILLINOINENSIS POLLEN; CARYA TOMENTOSA POLL
EN; CLADOSPORIUM CLADOSPORIOIDES; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES PTER
ONYSSINUS; FRAXINUS AMERICANA POLLEN; GALLUS GALLUS FEATHER; IVA ANNUA POLLEN; J
UNIPERUS VIRGINIANA POLLEN; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PERIPLANET
A AMERICANA; PHOMA DESTRUCTIVA; PLEOSPORA HERBARUM; POPULUS DELTOIDES POLLEN; QU
ERCUS ALBA POLLEN; RHIZOPUS STOLONIFER; SORGHUM HALEPENSE POLLEN; USTILAGO AVENA
E; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI .002; .002; .000
0266; .0000266; .002; .002; .002; .00008; .002; .00004; .00004; .00008; 16; 400;
.002; .0000266; .002; .00008; .00008; .002; .002; .002; .00008; .002; .002; .00
g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g
/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Standardized In
dient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic E
sed IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient
enic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Fungal Alle
zed Pollen Allergenic Extract [EPC]"
LEN; ACER SACCHARUM POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOL
IA POLLEN; AMBROSIA TRIFIDA POLLEN; BASSIA SCOPARIA POLLEN; BETULA ALLEGHANIENSI
S POLLEN; BETULA LENTA POLLEN; BETULA NIGRA POLLEN; BETULA OCCIDENTALIS POLLEN;
BETULA PAPYRIFERA POLLEN; BETULA POPULIFOLIA POLLEN; CHENOPODIUM ALBUM POLLEN; C
YCLACHAENA XANTHIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; IVA ANNUA POLLEN; JUGL
ANS NIGRA POLLEN; LOLIUM PERENNE POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OC
CIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; QUERCUS RUBRA
POLLEN; QUERCUS VIRGINIANA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN
; ULMUS AMERICANA POLLEN .00097; .00097; .00097; .0029; .00145; .00145; .
0029; .00048; .00048; .00048; .00048; .00048; .00048; .0029; .00145; .0029; .001
45; .0029; 5882; .0029; .0029; .0029; .00097; .00097; .00097; .0029; .0029; .002
9 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL;
Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/In
49288-0819_88d480d9-a016-4787-9db3-dcca62d0d1ca 49288-0819 NON-STANDARDIZED
ALLERGENIC Treatment Set TS342034 Treatment Set TS342034 "INJECTI
BLA102223 "Antigen Laboratories, Inc." CANIS LUPUS FAMILIARIS HAIR; PLA
NTAGO LANCEOLATA POLLEN .01; .01 g/mL; g/mL "Non-Standardized Animal
BLA102223 "Antigen Laboratories, Inc." ACER NEGUNDO POLLEN; ALTERNARIA
ALTERNATA; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; ASPERG
ILLUS FUMIGATUS; CARYA ILLINOINENSIS POLLEN; CARYA TOMENTOSA POLLEN; CYNODON DAC
TYLON POLLEN; FELIS CATUS HAIR; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN;
JUNIPERUS ASHEI POLLEN; PHLEUM PRATENSE POLLEN; PLATANUS OCCIDENTALIS POLLEN; P
OPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA K
ALI POLLEN; ULMUS AMERICANA POLLEN .002; .002; .002; 4000; .002; .001; .001
; 400; 400; .002; .002; .002; 4000; .002; .002; .002; .002; .002; .002 g/mL; g/
mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; [BAU
]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Non-Standardized Pollen Allerge
ollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Product
ion [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens
d Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/I
/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histami
ne Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander
[Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Pep
tides [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Inc
BLA102223 "Antigen Laboratories, Inc." CANIS LUPUS FAMILIARIS HAIR; FEL
IS CATUS HAIR; JUNIPERUS ASHEI POLLEN .01; 80; .01 g/mL; [BAU]/mL; g/mL
cal/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased
,Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Poll
BLA102223 "Antigen Laboratories, Inc." FELIS CATUS HAIR; FRAXINUS AMERI
CANA POLLEN; QUERCUS ALBA POLLEN 2000; .01; .002 [BAU]/mL; g/mL; g/mL
mical/Ingredient]"
49288-0823_da61c6b6-9055-4d5e-909c-eeb1bf0e016c 49288-0823 HUMAN PRESCRIPTI
OLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; ANAS PLATYRH
YNCHOS FEATHER; ANSER ANSER FEATHER; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; BET
ULA NIGRA POLLEN; CANDIDA ALBICANS; CLADOSPORIUM CLADOSPORIOIDES; CYNODON DACTYL
ON POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS
HAIR; FRAXINUS AMERICANA POLLEN; GALLUS GALLUS FEATHER; JUNIPERUS VIRGINIANA PO
LLEN; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PHOMA DESTRUCTIVA; PLANTAGO LANC
EOLATA POLLEN; PLEOSPORA HERBARUM; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLE
N; QUERCUS ALBA POLLEN; RHIZOPUS STOLONIFER; ULMUS AMERICANA POLLEN; USTILAGO AV
ENAE; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI .00008; .0006666
; .0006666; .0006666; .000027; .000027; .002; .002; .00008; .002; 16; 400; 16; 1
6; .002; .000027; .00008; .00008; .002; .0004; .002; 4000; .00008; .002; .002; .
g/mL; g/mL; [BAU]/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL;
g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Standar
len [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Ha
ity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [C
hemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standar
/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histami
ne Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathe
ty [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Stand
ardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-m
ediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredi
l/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increa
ne Release [PE],Non-Standardized Pollen Allergenic Extract [EPC],Increased Hista
c Extract [EPC],Increased Histamine Release [PE]"
49288-0824_bb49432e-682e-4b49-8a8e-a6f9eddd7bfc 49288-0824 HUMAN PRESCRIPTI
TUS; CLADOSPORIUM CLADOSPORIOIDES; COCHLIOBOLUS SATIVUS; PENICILLIUM CHRYSOGENUM
VAR. CHRYSOGENUM .01; .01; .01; .01; .01 g/mL; g/mL; g/mL; g/mL; g/mL
oteins [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
ARTEMISIIFOLIA POLLEN; AMBROSIA TRIFIDA POLLEN; ARTEMISIA VULGARIS POLLEN; CHENO
PODIUM ALBUM POLLEN; FRAXINUS AMERICANA POLLEN; IVA AXILLARIS POLLEN; KOCHIA SCO
PARIA POLLEN; LOLIUM PERENNE POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDE
NTALIS POLLEN; POPULUS ALBA POLLEN; POPULUS NIGRA POLLEN; QUERCUS ALBA POLLEN; Q
UERCUS RUBRA POLLEN; QUERCUS VIRGINIANA POLLEN; SALSOLA KALI POLLEN; SORGHUM HAL
EPENSE POLLEN; ULMUS AMERICANA POLLEN .003; .0015; .0015; .003; .003; .003; .0
03; .003; 6666.67; .003; .003; .0015; .0015; .001; .001; .001; .003; .003; .003
g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL
; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Non-Standardized Pollen Allergenic Extr
e Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergen
]"
ARTEMISIIFOLIA POLLEN; AVENA SATIVA POLLEN; CANIS LUPUS FAMILIARIS HAIR; CYNODON
DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELI
S CATUS HAIR; FESTUCA PRATENSIS POLLEN; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATEN
SE POLLEN; PLANTAGO LANCEOLATA POLLEN; SORGHUM HALEPENSE POLLEN .005; 800; .005;
.005; 1000; 80; 400; 1000; 800; .002; 800; .0004; .005 g/mL; [AU]/mL; g/mL; g/m
L; [BAU]/mL; [AU]/mL; [AU]/mL; [BAU]/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; g/mL
,Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen A
E],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pol
,Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insec
ty [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingre
dient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Sta
mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides
[Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/
Ingredient]"
XUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AVENA SATIVA POLLEN; BETULA POPULIFO
LIA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA TOMENTOSA POLLEN; CHENOPODIUM ALBU
M POLLEN; CYNODON DACTYLON POLLEN; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA
POLLEN; JUNIPERUS VIRGINIANA POLLEN; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE
POLLEN; PLANTAGO LANCEOLATA POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLE
N; RUMEX ACETOSELLA POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN; UR
TICA DIOICA POLLEN .0004; .0004; 800; .0004; .0004; .0002; .0002; .0004; 80
; 800; .0004; .0004; .0004; 800; .0004; .0004; .0004; .0004; .0004; .0004; .0004
g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/m
L; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Standardized Po
unity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Stan
dardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased I
gG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE]
TUS; CLADOSPORIUM HERBARUM; COCHLIOBOLUS SATIVUS; DERMATOPHAGOIDES FARINAE; DERM
ATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; FUSARIUM OXYSPORUM; PERIPLANETA AM
ERICANA .0004; .002; .002; .002; 400; 80; 400; .0004; .002 g/mL; g/mL; g/mL
; g/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL "Standardized Animal Hair Allerg
ngredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Ins
ical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allerge
emical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histam
ine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antig
ens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient
C],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins
PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergen
TICA DIOICA POLLEN .002; .002; 800; .002; .002; .0002; .0002; .002; 400; 40
00; .002; .002; .002; 800; .002; .002; .002; .002; .002; .002; .002 g/mL; g/
mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL;
[BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Standardized Pollen All
gens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell
t],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized
TUS; CANIS LUPUS FAMILIARIS HAIR; CLADOSPORIUM HERBARUM; COCHLIOBOLUS SATIVUS; D
ERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; EQUUS CABALLUS HAIR; FE
LIS CATUS HAIR; FUSARIUM OXYSPORUM; PERIPLANETA AMERICANA .002; .002; .002
; .005; .005; 400; 400; .0004; 80; .005; .005 g/mL; g/mL; g/mL; g/mL; g/mL; [A
U]/mL; [AU]/mL; g/mL; [BAU]/mL; g/mL; g/mL "Standardized Animal Hair Allerg
gens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Incr
n [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Sta
ell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chem
dient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine
Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Che
49288-0831_f38e0c9c-da50-41d7-a0c6-506be87d4981 49288-0831 HUMAN PRESCRIPTI
FOLIA POLLEN; ASPERGILLUS FUMIGATUS; FELIS CATUS HAIR .01; 20000; .01; 2000
g/mL; [AU]/mL; g/mL; [BAU]/mL "Standardized Animal Hair Allergenic Extract [EP
e [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allerge
TICA DIOICA POLLEN .00008; .002; 160; .00008; .00008; .00004; .00004; .0000
8; 16; 160; .00008; .002; .00008; 160; .00008; .00008; .00008; .00008; .00008; .
00008; .00008 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BA
U]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL
mical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated
Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increa
sed Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen A
3 "Antigen Laboratories, Inc." COCHLIOBOLUS SATIVUS; DERMATOPHAGOIDES F
ARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FUSARIUM OXYSPORUM; PERIPLANETA AMERICAN
A .00008; 400; 400; .002; .002 g/mL; [AU]/mL; [AU]/mL; g/mL; g/mL
reased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Inse
ct Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized I
nsect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Im
munity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/I
ngredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient]
OLIA POLLEN; AVENA SATIVA POLLEN; BETULA POPULIFOLIA POLLEN; CARYA ILLINOINENSIS
POLLEN; CARYA TOMENTOSA POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLL
EN; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; PASCOPYRUM SMITHII POLL
EN; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; POPULUS DELTOIDES POLLEN
; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS
AMERICANA POLLEN; URTICA DIOICA POLLEN .002; 160; .002; .01; .00004; .00004; .0
0008; 16; 400; .00008; .002; 400; .00008; .00008; .00008; .00008; .002; .00008;
.00008 g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g
/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Standardized Pollen All
ergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],
Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemica
3 "Antigen Laboratories, Inc." ALTERNARIA ALTERNATA; CLADOSPORIUM HERBA
RUM; COCHLIOBOLUS SATIVUS; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSI
NUS; FELIS CATUS HAIR; PERIPLANETA AMERICANA .002; .002; .002; 400; 400; 2000
; .01 g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL "Standardized An
t],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],
ction [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Che
Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
49288-0836_3d2e8502-9a04-4060-a553-26e1bf285501 49288-0836 HUMAN PRESCRIPTI
3 "Antigen Laboratories, Inc." ASPERGILLUS FUMIGATUS; AUREOBASIDIUM PUL
LULANS VAR. PULLUTANS; CLADOSPORIUM CLADOSPORIOIDES; COCHLIOBOLUS SATIVUS; FRAXI
NUS AMERICANA POLLEN; FUSARIUM OXYSPORUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGEN
UM; PHOMA DESTRUCTIVA; QUERCUS ALBA POLLEN; RHIZOPUS STOLONIFER .00004; .005; .0
0008; .005; .005; .005; .002; .005; .005; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/
mL; g/mL; g/mL; g/mL; g/mL "Non-Standardized Fungal Allergenic Extract [EPC
ent]"
49288-0837_3d2e8502-9a04-4060-a553-26e1bf285501 49288-0837 HUMAN PRESCRIPTI
FOLIA POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CA
TUS HAIR; FRAXINUS AMERICANA POLLEN; PASCOPYRUM SMITHII POLLEN; QUERCUS ALBA POL
LEN; SORGHUM HALEPENSE POLLEN .01; 4000; 400; 400; 400; .01; .01; .01; .002
g/mL; [AU]/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL "Standar
nt],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE
],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatopha
goides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Ch
nd Peptides [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],I
49288-0838_9a8e59e8-156a-4999-a000-b68054b405d3 49288-0838 HUMAN PRESCRIPTI
3 "Antigen Laboratories, Inc." CANIS LUPUS FAMILIARIS HAIR; DERMATOPHAG
OIDES PTERONYSSINUS .002; 2000 g/mL; [AU]/mL "Standardized Insect All
],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Stan
ell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredien
OLIA POLLEN; CANIS LUPUS FAMILIARIS HAIR; CARYA ILLINOINENSIS POLLEN; CARYA TOME
NTOSA POLLEN; FELIS CATUS HAIR; IVA ANNUA VAR. ANNUA POLLEN; JUGLANS NIGRA POLLE
N .002; 4000; .002; .001; .001; 400; .002; .002 g/mL; [AU]/mL; g/mL; g/m
L; g/mL; [BAU]/mL; g/mL; g/mL "Non-Standardized Pollen Allergenic Extract [EPC
t],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extra
IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],St
,Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingr
edient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical
/Ingredient]"
PUS FAMILIARIS HAIR; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; F
ELIS CATUS HAIR 20000; .01; 2000; 2000; 2000 [AU]/mL; g/mL; [AU]/mL; [AU]/mL;
[BAU]/mL "Standardized Animal Hair Allergenic Extract [EPC],Increased His
tamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Da
nder [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and
Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract
Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Stand
roteins [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
OLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; CARYA ILLINO
INENSIS POLLEN; CARYA TOMENTOSA POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERIC
ANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; PLANTAGO LANCEOLATA POLLEN; POA PRATENS
IS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; SORGHUM HALEPENSE POLL
EN; ULMUS AMERICANA POLLEN .00008; .00067; .00067; .00067; .001; .001; 16;
.00008; .002; .002; 4000; .00008; .002; .002; .002 g/mL; g/mL; g/mL; g/mL;
g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL
E],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
R. PULLUTANS; CANDIDA ALBICANS; CANIS LUPUS FAMILIARIS HAIR; COCHLIOBOLUS SATIVU
S; DERMATOPHAGOIDES FARINAE; GALLUS GALLUS FEATHER; PENICILLIUM CHRYSOGENUM VAR.
CHRYSOGENUM; PERIPLANETA AMERICANA; PHOMA DESTRUCTIVA; PLEOSPORA HERBARUM; RHIZ
OPUS STOLONIFER; SPORISORIUM CRUENTUM; USTILAGO CYNODONTIS .002; .00003; .0
0003; .002; .002; .002; .00008; .00008; 400; .00003; .0008; .00008; .00008; .002
; .002; .001; .001 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL;
g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Standardized Insect Allergenic
],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extrac
-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],C
ell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemic
c Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fun
dient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins
llergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Fungal
G Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient]
,Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [
PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemic
al/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Hista
mine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],All
3 "Antigen Laboratories, Inc." AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA
TRIFIDA POLLEN 20000; .01 [AU]/mL; g/mL "Standardized Pollen Allergenic
ical/Ingredient]"
FEATHER; ASPERGILLUS FUMIGATUS; CLADOSPORIUM CLADOSPORIOIDES; COCHLIOBOLUS SATIV
US; DERMATOPHAGOIDES FARINAE; FELIS CATUS HAIR; GALLUS GALLUS FEATHER; PENICILLI
UM CHRYSOGENUM VAR. CHRYSOGENUM; PHOMA DESTRUCTIVA; PLEOSPORA HERBARUM; SPORISOR
IUM CRUENTUM; USTILAGO AVENAE; USTILAGO CYNODONTIS; USTILAGO MAYDIS; USTILAGO NU
DA HORDEI; USTILAGO TRITICI .00067; .00067; .00008; .0004; .0004; 400; 80; .
00067; .0004; .002; .00008; .001; .0005; .001; .0005; .0005; .0005 g/mL; g/
mL; g/mL; g/mL; g/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/m
L; g/mL; g/mL; g/mL "Standardized Animal Hair Allergenic Extract [EPC],Incre
eins and Peptides [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extra
ct [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Pro
teins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect
[PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredi
ent],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-S
ent],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Relea
se [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chem
ical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allerg
IA TRIFIDA POLLEN; BETULA NIGRA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA TOMENT
OSA POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERICAN
A POLLEN; JUNIPERUS VIRGINIANA POLLEN; PLANTAGO LANCEOLATA POLLEN; POA PRATENSIS
POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN;
SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN .00008;
.0004; .00013; .00013; .00013; .00008; .00004; .00004; .002; 16; .00008; .002; .
0004; 160; .00008; .00008; .0004; .002; .00008; .00008 g/mL; g/mL; g/mL; g/mL;
g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL;
g/mL; g/mL; g/mL; g/mL "Standardized Pollen Allergenic Extract [EPC],Increased
,Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],In
creased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Rel
ease [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Ext
XUS WHOLE; AMBROSIA ARTEMISIIFOLIA POLLEN; BETULA POPULIFOLIA POLLEN; CHENOPODIU
M ALBUM POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; PASCOPYRUM S
MITHII POLLEN; PLANTAGO LANCEOLATA POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALB
A POLLEN; RUMEX ACETOSELLA POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POL
LEN .002; .002; 160; .01; .002; 400; .0004; .002; .002; .002; .002; .004; .0
004; .0004 g/mL; g/mL; [AU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/m
L; g/mL; g/mL; g/mL; g/mL "Standardized Pollen Allergenic Extract [EPC],In
ct [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemi
cal/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient]
redient]"
TUS; CANIS LUPUS FAMILIARIS HAIR; CLADOSPORIUM HERBARUM; DERMATOPHAGOIDES FARINA
E; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR .0004; .01; .0004; .0004
; 16; 16; 80 g/mL; g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; [BAU]/mL "Non-Sta
ngredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic E
sed IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredi
ent],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Anima
49288-0848_bfb6bdbb-da65-4cb3-a50d-250270cdd448 49288-0848 HUMAN PRESCRIPTI
ARTEMISIIFOLIA POLLEN; AVENA SATIVA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA TO
MENTOSA POLLEN; CYNODON DACTYLON POLLEN; PASCOPYRUM SMITHII POLLEN; PERIPLANETA
AMERICANA; PHLEUM PRATENSE POLLEN; RUMEX ACETOSELLA POLLEN .002; 160; .002;
.001; .001; 16; .0004; .002; 160; .0004 g/mL; [AU]/mL; g/mL; g/mL; g/mL;
[BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL "Standardized Pollen Allergenic Extract
],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/I
ic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Polle
n [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ing
cal/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergen
creased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Che
mical/Ingredient]"
FOLIA POLLEN; ARTEMISIA ABSINTHIUM POLLEN; CARYA TOMENTOSA POLLEN; CYNODON DACTY
LON POLLEN; DERMATOPHAGOIDES FARINAE; FELIS CATUS HAIR; PENICILLIUM CHRYSOGENUM
VAR. CHRYSOGENUM; PLEOSPORA HERBARUM; RUMEX ACETOSELLA POLLEN .002; 4000; .005
; .005; 1000; 1000; 400; .005; .005; .005 g/mL; g/mL; g/mL; g/mL; [BAU]/mL
; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL "Standardized Pollen Allergenic Extract
ediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [
Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/I
des [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Incre
t],Increased Histamine Release [PE],Allergens [Chemical/Ingredient]"
A; AMBROSIA ARTEMISIIFOLIA POLLEN; CANIS LUPUS FAMILIARIS HAIR; CARYA ILLINOINEN
SIS POLLEN; CARYA TOMENTOSA POLLEN; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FA
RINAE; DERMATOPHAGOIDES PTERONYSSINUS; EQUUS CABALLUS HAIR; FELIS CATUS HAIR; FE
STUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; PHLEUM PRATENSE POLLEN; POPUL
US DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN .002; .0
02; 800; .002; .0002; .0002; 400; 80; 80; .00008; 80; 4000; .002; 4000; .002; .0
004; .002 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [AU]/m
L; g/mL; [BAU]/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL "Non-Standardize
ivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair A
t Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized In
Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increas
ed IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release
[PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC
n-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release
[PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ing
OLIA POLLEN; AVENA SATIVA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA TOMENTOSA PO
LLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR
; FESTUCA PRATENSIS POLLEN; PASCOPYRUM SMITHII POLLEN; PERIPLANETA AMERICANA; PH
LEUM PRATENSE POLLEN; SORGHUM HALEPENSE POLLEN .0004; 800; .0004; .0002; .0002;
400; 400; 400; 800; .002; .00008; 160; .002 g/mL; [AU]/mL; g/mL; g/mL; g/mL;
[AU]/mL; [AU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL "Standar
ollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal
unity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens
[Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-S
l-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical
XUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; CARYA TOMENTOSA POLLEN; CYNODON DACT
YLON POLLEN; FELIS CATUS HAIR; JUNIPERUS ASHEI POLLEN; MORUS ALBA POLLEN; PLANTA
GO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POA PRATENSIS POLLEN; QUERCU
S ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE P
OLLEN; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN .0004; .0004; 160; .0004
; 16; 400; .002; .0004; .0004; .0004; 160; .00008; .002; .0004; .00008; .0004; .
002 g/mL; g/mL; [AU]/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [
BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Standardized Animal Hair Allerg
ngredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Pol
EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/
Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non
A; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; BETULA POPULIF
OLIA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA TOMENTOSA POLLEN; CHENOPODIUM ALB
UM POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; EQUUS CABALLUS HAIR; FELIS CATUS HAIR
; FRAXINUS AMERICANA POLLEN; JUNIPERUS VIRGINIANA POLLEN; PASCOPYRUM SMITHII POL
LEN; PERIPLANETA AMERICANA; PHLEUM PRATENSE POLLEN; POPULUS DELTOIDES POLLEN; PO
PULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; URTICA DIO
ICA POLLEN .00008; .002; .002; 4000; .002; .00004; .00004; .0004; 16; .01;
400; .00008; .0004; .002; .0004; 800; .00008; .0004; .00008; .00008; .0004
g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; [BAU]/mL; g/mL
; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Non-Standardize
PC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/I
ngredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Stan
redient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic
ient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Rele
ase [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemi
cal/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [
nt],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [
EPC],Increased Histamine Release [PE]"
PUS FAMILIARIS HAIR; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOP
HAGOIDES PTERONYSSINUS; IVA ANNUA POLLEN; PHLEUM PRATENSE POLLEN 4000; .0
05; 1000; 1000; 1000; .005; 4000 [AU]/mL; g/mL; [BAU]/mL; [AU]/mL; [AU]/m
L; g/mL; [BAU]/mL "Standardized Insect Allergenic Extract [EPC],Increased
[Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal H
nity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Che
gredient]"
49288-0855_fdad2abe-8504-4d78-9599-5e850d792dc8 49288-0855 NON-STANDARDIZED
ILLUS FUMIGATUS; BETULA POPULIFOLIA POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; JUGL
ANS NIGRA POLLEN; JUNIPERUS VIRGINIANA POLLEN; MORUS RUBRA POLLEN; PASCOPYRUM SM
ITHII POLLEN; PERIPLANETA AMERICANA; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDE
NTALIS POLLEN; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN .002; .002; .002
; 4000; .002; .002; 400; .002; .002; .002; .002; .002; .002; .002; .002; .002
g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/
mL; g/mL; g/mL; g/mL "Standardized Pollen Allergenic Extract [EPC],Increased
Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-S
ell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chem
BLA102223 "Antigen Laboratories, Inc." ACER NEGUNDO POLLEN; AMARANTHUS
RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AVENA SATIVA POLLEN; CARYA I
LLINOINENSIS POLLEN; CARYA TOMENTOSA POLLEN; CYNODON DACTYLON POLLEN; FESTUCA PR
ATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; JUNIPERUS VIRGINIANA POLLEN; PASCOPYR
UM SMITHII POLLEN; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; SORGHUM H
ALEPENSE POLLEN .002; .00008; 160; .0004; .00004; .00004; 16; 800; .0004; .002;
.0004; 160; .002; .00008 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; [BAU]/mL;
[BAU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL "Non-Standardized Pollen
BLA102223 "Antigen Laboratories, Inc." ALTERNARIA ALTERNATA; CANIS LUPU
S FAMILIARIS HAIR; COCHLIOBOLUS SATIVUS; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOI
DES PTERONYSSINUS; FELIS CATUS HAIR; PERIPLANETA AMERICANA .002; .002; .01;
80; 80; 80; .01 g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL
emical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Alle
],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical
/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardiz
ergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increa
[PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/
Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extra
ion [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
RETROFLEXUS POLLEN; BETULA POPULIFOLIA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA
TOMENTOSA POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; JUNIPERUS
VIRGINIANA POLLEN; MORUS RUBRA POLLEN; PHLEUM PRATENSE POLLEN; POPULUS DELTOIDE
S POLLEN; QUERCUS ALBA POLLEN; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN
.005; .005; .00008; .001; .001; 400; .0004; .002; .002; 10000; .005; .00008; .00
5; .005 g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL
munity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Sta
"
BLA102223 "Antigen Laboratories, Inc." AMARANTHUS RETROFLEXUS POLLEN; A
MBROSIA ARTEMISIIFOLIA POLLEN; JUNIPERUS VIRGINIANA POLLEN; PHLEUM PRATENSE POLL
EN; POPULUS DELTOIDES POLLEN .002; 800; .00008; 4000; .002 g/mL; [AU]/mL; g
/mL; [BAU]/mL; g/mL "Non-Standardized Pollen Allergenic Extract [EPC],Increa
ALTERNATA; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AVENA
SATIVA POLLEN; BETULA POPULIFOLIA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA TOME
NTOSA POLLEN; CHENOPODIUM ALBUM POLLEN; COCHLIOBOLUS SATIVUS; CYNODON DACTYLON P
OLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS VIRGINIANA POL
LEN; MORUS RUBRA POLLEN; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; PLA
TANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX
ACETOSELLA POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN; URTICA DIOI
CA POLLEN .0004; .002; .002; 4000; .002; .002; .00004; .00004; .002; .002;
400; .00008; .002; .0004; .002; 4000; .002; .002; .002; .00008; .002; .002; .00
2; .002 g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL;
g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/m
L "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Re
hemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediat
ed Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Incr
eased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen
ent]"
RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AVENA SATIVA POLLEN; CARYA I
LLINOINENSIS POLLEN; CARYA TOMENTOSA POLLEN; CYNODON DACTYLON POLLEN; FESTUCA PR
ATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; JUNIPERUS VIRGINIANA POLLEN; PASCOPYR
UM SMITHII POLLEN; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS
OCCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; RUMEX ACETOSELLA POLLEN; SORGHUM
HALEPENSE POLLEN .002; .002; 4000; .002; .001; .001; 400; 160; .002; .000
4; .00008; 160; .002; .002; .002; .002; .0004 g/mL; g/mL; [AU]/mL; g/mL; g/mL;
g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g
/mL "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Re
mical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated
Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increa
sed Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen A
S FAMILIARIS HAIR; COCHLIOBOLUS SATIVUS; FELIS CATUS HAIR; PERIPLANETA AMERICANA
.0004; .01; .01; 400; .01 g/mL; g/mL; g/mL; [BAU]/mL; g/mL "Standar
emical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Aller
,Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [
RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; BETULA POPULIFOLIA POLLEN; C
ARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; FRAXINUS AMERICANA POLLEN;
JUGLANS NIGRA POLLEN; JUNIPERUS VIRGINIANA POLLEN; MORUS RUBRA POLLEN; PLANTAGO
LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS ALBA POLLEN; POPULUS DE
LTOIDES POLLEN; POPULUS NIGRA POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLL
EN; SALIX NIGRA POLLEN; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN .002; .0
0008; 160; .005; .00004; .0004; .00008; .00008; .005; .0004; .002; .0004; .001;
.0004; .001; .002; .005; .002; .0004; .0004 g/mL; g/mL; [AU]/mL; g/mL; g/mL;
g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g
/mL; g/mL "Non-Standardized Pollen Allergenic Extract [EPC],Increased Hist
nity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardi
nt],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standar
t]"
BLA102223 "Antigen Laboratories, Inc." ALTERNARIA ALTERNATA; AVENA SATI
VA POLLEN; CANIS LUPUS FAMILIARIS HAIR; COCHLIOBOLUS SATIVUS; CYNODON DACTYLON P
OLLEN; FELIS CATUS HAIR; FESTUCA PRATENSIS POLLEN; FUSARIUM OXYSPORUM; PASCOPYRU
M SMITHII POLLEN; PHLEUM PRATENSE POLLEN; SORGHUM HALEPENSE POLLEN .005; .0
004; .005; .005; 16; 16; 10000; .005; .0004; 160; .0004 g/mL; g/mL; g/mL; g/mL;
[BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL "Standardized Po
llen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal H
nity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [
Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-St
49288-0865_f6f33373-7c0b-4834-add6-a7c79d24e403 49288-0865 NON-STANDARDIZED
RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; ASPERGILLUS FUMIGATUS; AVENA
SATIVA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CYNODON DACTYLON
POLLEN; FELIS CATUS HAIR; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; F
USARIUM OXYSPORUM; JUNIPERUS VIRGINIANA POLLEN; MORUS RUBRA POLLEN; PASCOPYRUM S
MITHII POLLEN; PERIPLANETA AMERICANA; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOLAT
A POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; SORGHUM HALEPENSE POLLE
N; URTICA DIOICA POLLEN .002; .002; 4000; .002; .00008; .00004; .00004; 16; 400;
160; .002; .002; .002; .002; .0004; .002; 800; .002; .002; .002; .0004; .002
g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL;
g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Non-Sta
ent],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract
G Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],S
alivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Insect Alle
],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens
Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/In
y [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient]"
ARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; FRAXINUS
AMERICANA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS VIRGINIANA POLLEN; MORUS RUBR
A POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS ALBA
POLLEN; POPULUS DELTOIDES POLLEN; POPULUS NIGRA POLLEN; QUERCUS ALBA POLLEN; RU
MEX ACETOSELLA POLLEN; SALIX NIGRA POLLEN; ULMUS AMERICANA POLLEN; URTICA DIOICA
POLLEN .0004; .0004; 160; .002; .00004; .00004; .002; .0004; .002; .002; .0004;
.002; .00008; .001; .002; .001; .002; .0004; .002; .002; .002 g/mL; g/mL; [AU]
/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/m
L; g/mL; g/mL; g/mL; g/mL; g/mL "Non-Standardized Pollen Allergenic Extract [EPC
emical/Ingredient]"
BLA102223 "Antigen Laboratories, Inc." ALTERNARIA ALTERNATA; ASPERGILLU
S FUMIGATUS; AVENA SATIVA POLLEN; CANIS LUPUS FAMILIARIS HAIR; CLADOSPORIUM HERB
ARUM; COCHLIOBOLUS SATIVUS; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; D
ERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; FESTUCA PRATENSIS POLLEN; FUSAR
IUM OXYSPORUM; PASCOPYRUM SMITHII POLLEN; PERIPLANETA AMERICANA; PHLEUM PRATENSE
POLLEN; SORGHUM HALEPENSE POLLEN .002; .002; .002; .002; .002; .002; 16;
80; 400; 400; 4000; .002; .0004; .002; 800; .002 g/mL; g/mL; g/mL; g/mL;
g/mL; g/mL; [BAU]/mL; [AU]/mL; [AU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; [B
AU]/mL; g/mL "Standardized Animal Hair Allergenic Extract [EPC],Increased His
tamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Da
nder [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and
Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract
Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-S
/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extr
IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Pro
teins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect
[PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredi
ent],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-S
ALTERNATA; AMBROSIA ARTEMISIIFOLIA POLLEN; ASPERGILLUS FUMIGATUS; AVENA SATIVA P
OLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CYNODON DACTYLON POLLEN; F
ELIS CATUS HAIR; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NI
GRA POLLEN; MORUS RUBRA POLLEN; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLE
N; PLANTAGO LANCEOLATA POLLEN; RUMEX ACETOSELLA POLLEN; SORGHUM HALEPENSE POLLEN
; URTICA DIOICA POLLEN .002; .002; 4000; .002; .00008; .0002; .0002; 400; 400;
4000; .002; .002; .0004; .0004; 4000; .002; .002; .002; .002 g/mL; g/mL; [AU]
/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/m
L; [BAU]/mL; g/mL; g/mL; g/mL; g/mL "Non-Standardized Pollen Allergenic Extr
Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Inc
reased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Rele
ase [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract
ivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Fungal Allerg
istamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingr
RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AVENA SATIVA POLLEN; BETULA
NIGRA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM P
OLLEN; CYNODON DACTYLON POLLEN; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POL
LEN; JUGLANS NIGRA POLLEN; JUNIPERUS VIRGINIANA POLLEN; PASCOPYRUM SMITHII POLLE
N; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POL
LEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES POLLEN; POPULUS NIGRA POLLEN; QUERCU
S ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALIX NIGRA POLLEN; SORGHUM HALEPENSE PO
LLEN; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN .0004; .00008; 4000; .00
2; .0004; .00004; .00004; .0004; 16; 4000; .00008; .0004; .00008; .002; 800; .00
2; .0004; .0002; .00008; .0002; .0004; .0004; .0004; .002; .00008; .0004
L; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g
nity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardi
nt],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardize
PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Po
tion [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
S FAMILIARIS HAIR; COCHLIOBOLUS SATIVUS; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOI
DES PTERONYSSINUS; FELIS CATUS HAIR; MORUS RUBRA POLLEN .01; .002; .002; 400; 20
00; 80; .0004 g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL "Standar
reased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Inse
ct Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized I
nsect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Im
munity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/I
ngredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient]
VENA SATIVA POLLEN; BROUSSONETIA PAPYRIFERA POLLEN; CARYA ALBA POLLEN; CARYA ILL
INOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; FELIS CATU
S HAIR; FESTUCA PRATENSIS POLLEN; JUGLANS NIGRA POLLEN; MORUS ALBA POLLEN; MORUS
RUBRA POLLEN; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN; PLANTAGO LANCE
OLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS ALBA POLLEN; POPULUS NIGRA P
OLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SORGHUM HALEPENSE POLLEN; U
RTICA DIOICA POLLEN .002; .00008; .00067; .00004; .00004; .002; 80; 80; 160;
.0004; .00067; .00067; .00008; 160; .002; .002; .001; .001; .002; .002; .00008;
.002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL;
g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL
llergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE
],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemi
gredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine
Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [C
hemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptid
es [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increa
ediated Immunity [PE],Increased IgG Production [PE]"
BLA102223 "Antigen Laboratories, Inc." ACER NEGUNDO POLLEN; BETULA POPU
LIFOLIA POLLEN; BROUSSONETIA PAPYRIFERA POLLEN; CANIS LUPUS FAMILIARIS HAIR; CAR
YA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; COCHLIOBOLUS SATIVUS; CYNODON DACTYL
ON POLLEN; FELIS CATUS HAIR; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN
; JUGLANS NIGRA POLLEN; JUNIPERUS VIRGINIANA POLLEN; MORUS ALBA POLLEN; MORUS RU
BRA POLLEN; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN; POPULUS ALBA POLL
EN; POPULUS NIGRA POLLEN; QUERCUS ALBA POLLEN; SALIX NIGRA POLLEN; SORGHUM HALEP
ENSE POLLEN .0004; .002; .00013; .002; .00004; .00004; .002; 400; 400; 4000;
.002; .002; .002; .00013; .00013; .002; 800; .001; .001; .0004; .002; .0004
g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/
mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Standar
ens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Incr
n [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Pro
teins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic
sed Histamine Release [PE],Cell-mediated Immunity [PE]"
BLA102223 "Antigen Laboratories, Inc." ALTERNARIA ALTERNATA; AMARANTHUS
RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AVENA SATIVA POLLEN; CARYA
ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; COCHLIOBOLUS
SATIVUS; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTE
RONYSSINUS; FELIS CATUS HAIR; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLE
N; FUSARIUM OXYSPORUM; MORUS RUBRA POLLEN; PASCOPYRUM SMITHII POLLEN; PHLEUM PRA
TENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS
DELTOIDES POLLEN; RUMEX ACETOSELLA POLLEN; SORGHUM HALEPENSE POLLEN .002; .0
02; 4000; .002; .001; .001; .002; .002; 80; 400; 400; 400; 800; .002; .002; .000
4; .002; 800; .002; .002; .002; .002; .002 g/mL; g/mL; [AU]/mL; g/mL; g/mL;
g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [AU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g
/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Non-Standardized Pollen
ity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardiz
t],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized
,Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Anima
mmunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergen
s [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Sta
emical/Ingredient]"
BLA102223 "Antigen Laboratories, Inc." CARYA ALBA POLLEN; CARYA ILLINOI
NENSIS POLLEN; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; PASCOPYRUM S
MITHII POLLEN; PHLEUM PRATENSE POLLEN; QUERCUS ALBA POLLEN .0002; .0002; 20
000; .0004; .01; 4000; .0004 g/mL; g/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL
S FAMILIARIS HAIR; COCHLIOBOLUS SATIVUS; CYNODON DACTYLON POLLEN; EQUUS CABALLUS
HAIR; FELIS CATUS HAIR; FESTUCA PRATENSIS POLLEN; MORUS RUBRA POLLEN; PASCOPYRU
M SMITHII POLLEN; PHLEUM PRATENSE POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS
DELTOIDES POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN .002; .0
02; .00008; 1000; .002; 80; 4000; .005; .002; 4000; .002; .002; .005; .005
g/mL; g/mL; g/mL; [BAU]/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL
len [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Ha
ity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [C
hemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Sta
ollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Ani
Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens
RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; CARYA ALBA POLLEN; CARYA ILL
INOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS
NIGRA POLLEN; JUNIPERUS VIRGINIANA POLLEN; MORUS RUBRA POLLEN; PLANTAGO LANCEOLA
TA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA
POLLEN; RUMEX ACETOSELLA POLLEN; SALIX NIGRA POLLEN; ULMUS AMERICANA POLLEN; URT
ICA DIOICA POLLEN .0004; .0004; 4000; .00004; .00004; .0004; .0004; .0004;
.00008; .00008; .002; .0004; .00008; .00008; .0004; .002; .0004; .002 g/mL; g/
mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g
/mL; g/mL; g/mL; g/mL "Non-Standardized Pollen Allergenic Extract [EPC],Increa
ted Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],S
redient]"
VA POLLEN; CANIS LUPUS FAMILIARIS HAIR; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDE
S PTERONYSSINUS; FESTUCA PRATENSIS POLLEN; PASCOPYRUM SMITHII POLLEN; SORGHUM HA
LEPENSE POLLEN .002; .01; .002; 80; 2000; 20000; .002; .00008 g/mL; g/mL; g/mL
; [BAU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL "Standardized Pollen Allergenic
ient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine
Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chem
SATIVA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; COCHLIOBOLUS SATIV
US; CYNODON DACTYLON POLLEN; FELIS CATUS HAIR; FRAXINUS AMERICANA POLLEN; JUNIPE
RUS VIRGINIANA POLLEN; MORUS RUBRA POLLEN; PHLEUM PRATENSE POLLEN; PLATANUS OCCI
DENTALIS POLLEN; QUERCUS ALBA POLLEN; SALIX NIGRA POLLEN; SORGHUM HALEPENSE POLL
EN; ULMUS AMERICANA POLLEN .002; .002; .002; 800; .002; .0002; .0002; .002;
400; 400; .0004; .002; .002; 800; .002; .002; .002; .002; .002 g/mL; g/mL; g/mL
; [AU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; [BAU]/m
Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingre
dient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/
BLA102223 "Antigen Laboratories, Inc." ALTERNARIA ALTERNATA; AMBROSIA A
RTEMISIIFOLIA POLLEN; AVENA SATIVA POLLEN; BETULA NIGRA POLLEN; CARYA ALBA POLLE
N; CARYA ILLINOINENSIS POLLEN; CYNODON DACTYLON POLLEN; PHLEUM PRATENSE POLLEN;
PLANTAGO LANCEOLATA POLLEN; QUERCUS ALBA POLLEN; SORGHUM HALEPENSE POLLEN; URTIC
A DIOICA POLLEN .002; 10000; .0004; .005; .001; .001; 400; 4000; .005; .002; .00
2; .005 g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g
RETROFLEXUS POLLEN; ASPERGILLUS FUMIGATUS; CARYA ALBA POLLEN; CARYA ILLINOINENS
IS POLLEN; CLADOSPORIUM HERBARUM; DERMATOPHAGOIDES PTERONYSSINUS; EQUUS CABALLUS
HAIR; FRAXINUS AMERICANA POLLEN; PLANTAGO LANCEOLATA POLLEN; URTICA DIOICA POLL
EN .002; .005; .005; .001; .001; .005; 400; .002; .005; .002; .002 g/mL; g/
mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL "Non-Standardize
mmunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredien
,Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
RETROFLEXUS POLLEN; ASPERGILLUS FUMIGATUS; AVENA SATIVA POLLEN; CANIS LUPUS FAM
ILIARIS HAIR; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; DERMATOPHAGOIDES PT
ERONYSSINUS; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDE
NTALIS POLLEN; QUERCUS ALBA POLLEN .002; .002; .002; .002; .01; .001; .001;
2000; 4000; .01; .002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/m
L; [BAU]/mL; g/mL; g/mL; g/mL "Non-Standardized Pollen Allergenic Extract [EPC
unity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient]
ALTERNATA; AMARANTHUS RETROFLEXUS POLLEN; AVENA SATIVA POLLEN; CARYA ALBA POLLEN
; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; DERMATOPHAGOIDES PTERONY
SSINUS; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS VIRGINIANA PO
LLEN; MORUS RUBRA POLLEN; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; PL
ATANUS OCCIDENTALIS POLLEN; QUERCUS ALBA POLLEN; ULMUS AMERICANA POLLEN; URTICA
DIOICA POLLEN .002; .002; .0004; .002; .0002; .0002; .002; 400; .002; .002; .0
004; .002; 4000; .002; .002; .002; .002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/
mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/m
Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect
y [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingred
ient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-
n [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
BLA102223 "Antigen Laboratories, Inc." ALTERNARIA ALTERNATA; ANAS PLATY
RHYNCHOS FEATHER; ANSER ANSER FEATHER; BOS TAURUS HAIR; CANIS LUPUS FAMILIARIS H
AIR; CLADOSPORIUM HERBARUM; COCHLIOBOLUS SATIVUS; DERMATOPHAGOIDES PTERONYSSINUS
; EQUUS CABALLUS HAIR; FELIS CATUS HAIR; GALLUS GALLUS FEATHER; ODOCOILEUS VIRGI
NIANUS HAIR; ORYCTOLAGUS CUNICULUS HAIR; PERIPLANETA AMERICANA .002; .00067; .0
067; .005; .002; .005; .002; 400; .00008; 400; .00067; .005; .005; .002 g/mL; g/
mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/m
L "Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine R
s [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],In
ion [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardi
ed Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredi
gredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergeni
reased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredi
se [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chem
ical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allerg
-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [
/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased His
tamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Al
lergens [Chemical/Ingredient],Fur [Chemical/Ingredient]"
BLA102223 "Antigen Laboratories, Inc." ACER NEGUNDO POLLEN; AVENA SATIV
A POLLEN; BETULA POPULIFOLIA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLL
EN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; FESTUCA PRATENSIS POLLEN;
FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS VIRGINIANA POLLEN; M
ORUS RUBRA POLLEN; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN; PLANTAGO L
ANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS ALBA POLLEN; POPULUS DEL
TOIDES POLLEN; POPULUS NIGRA POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLE
N; SALIX NIGRA POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN; URTICA
DIOICA POLLEN .002; .00008; .00008; .0002; .0002; .002; 16; 160; .00008; .002;
.002; .002; .00008; 160; .002; .002; .004; .002; .004; .00008; 4000; .002; .000
4; .002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/
mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/m
L; g/mL; g/mL; g/mL "Non-Standardized Pollen Allergenic Extract [EPC],Increa
ized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG P
roduction [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],All
"
49288-0885_e266b12c-c311-4e1b-9d5a-1f448a15eb0e 49288-0885 NON-STANDARDIZED
ALLERGENIC Treamtent Set TS347738 Treamtent Set TS347738 "INJECTI
RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; CARYA ALBA POLLEN; CARYA IL
LINOINENSIS POLLEN; COCHLIOBOLUS SATIVUS; CYNODON DACTYLON POLLEN; FELIS CATUS H
AIR; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; MORUS RUBRA POLLEN; PASCOP
YRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPUL
US ALBA POLLEN; POPULUS DELTOIDES POLLEN; POPULUS NIGRA POLLEN; QUERCUS ALBA POL
LEN; URTICA DIOICA POLLEN .002; .002; 4000; .001; .001; .00008; 80; 400; .
002; .002; .002; .002; 160; .002; .001; .002; .001; .002; .002 g/mL; g/mL; [AU]
/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/m
Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingre
dient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/
AMERICANA POLLEN; JUNIPERUS VIRGINIANA POLLEN; MORUS RUBRA POLLEN; PLANTAGO LAN
CEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS
ALBA POLLEN; RUMEX ACETOSELLA POLLEN; URTICA DIOICA POLLEN .002; .0004; 160
; .002; .001; .001; .002; .002; .0004; .002; .002; .002; .002; .002; .0004; .002
g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL;
g/mL; g/mL; g/mL "Non-Standardized Pollen Allergenic Extract [EPC],Increa
ted Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],S
dient]"
S FUMIGATUS; AVENA SATIVA POLLEN; CANIS LUPUS FAMILIARIS HAIR; CYNODON DACTYLON
POLLEN; FELIS CATUS HAIR; FESTUCA PRATENSIS POLLEN; FUSARIUM OXYSPORUM; PASCOPYR
UM SMITHII POLLEN; PERIPLANETA AMERICANA; PHLEUM PRATENSE POLLEN; SORGHUM HALEPE
NSE POLLEN .0004; .002; .0004; .002; 16; 400; 800; .002; .0004; .002; 160;
.002 g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL;
[BAU]/mL; g/mL "Standardized Pollen Allergenic Extract [EPC],Increased Histamin
ction [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standar
ated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingre
49288-0888_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0888 NON-STANDARDIZED
MBROSIA ARTEMISIIFOLIA POLLEN; AVENA SATIVA POLLEN; CANIS LUPUS FAMILIARIS HAIR;
FELIS CATUS HAIR; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN .005; 10
000; .005; .002; 400; .005; 10000 g/mL; [AU]/mL; g/mL; g/mL; [BAU]/mL; g/m
L; [BAU]/mL "Non-Standardized Pollen Allergenic Extract [EPC],Increased Hist
s [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increa
[PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Prote
ins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic E
sed IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient
]"
ALTERNATA; AMBROSIA ARTEMISIIFOLIA POLLEN; CANIS LUPUS FAMILIARIS HAIR; CYNODON
DACTYLON POLLEN; FELIS CATUS HAIR; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENT
ALIS POLLEN; POA PRATENSIS POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN;
SORGHUM HALEPENSE POLLEN .002; .002; 4000; .002; 400; 400; .002; .002; 40
00; .002; .002; .002 g/mL; g/mL; [AU]/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/m
L; [BAU]/mL; g/mL; g/mL; g/mL "Standardized Animal Hair Allergenic Extract [EP
eins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Poll
eased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen
mical/Ingredient]"
POPULIFOLIA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM A
LBUM POLLEN; CYNODON DACTYLON POLLEN; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICA
NA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS VIRGINIANA POLLEN; MORUS RUBRA POLLEN
; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOLATA POLLEN;
PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RU
MEX ACETOSELLA POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN; URTICA
DIOICA POLLEN .002; .002; 4000; .002; .002; .001; .001; .002; 80; 4000; .0004;
.002; .002; .002; .002; 4000; .002; .002; .0004; .0004; .002; .002; .002; .002
L; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL
Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immun
ity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Hi
stamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allerge
S FUMIGATUS; CLADOSPORIUM HERBARUM; COCHLIOBOLUS SATIVUS; FUSARIUM OXYSPORUM; PE
RIPLANETA AMERICANA .002; .01; .01; .01; .01; .002 g/mL; g/mL; g/mL; g/mL;
g/mL; g/mL "Non-Standardized Insect Allergenic Extract [EPC],Increased Hist
ect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardi
[EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Protei
RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AVENA SATIVA POLLEN; CARYA A
LBA POLLEN; CARYA ILLINOINENSIS POLLEN; CYNODON DACTYLON POLLEN; FESTUCA PRATENS
IS POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS VIRGINIANA
POLLEN; MORUS RUBRA POLLEN; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN;
PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUM
EX ACETOSELLA POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN; URTICA D
IOICA POLLEN .002; .002; 4000; .0004; .0002; .0002; 400; 4000; .002; .002; .0
004; .002; .002; 800; .0004; .002; .002; .002; .0004; .002; .002 g/mL; g/
mL; [AU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BA
U]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Non-Standardized Pollen Allerge
n Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production
[PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Ch
S FAMILIARIS HAIR; COCHLIOBOLUS SATIVUS; FELIS CATUS HAIR .002; .01; .002;
400 g/mL; g/mL; g/mL; [BAU]/mL "Standardized Animal Hair Allergenic Ext
AMERICANA POLLEN; JUGLANS NIGRA POLLEN; MORUS RUBRA POLLEN; PLANTAGO LANCEOLATA
POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES PO
LLEN; POPULUS NIGRA POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALIX
NIGRA POLLEN; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN .002; .00008; 40
00; .002; .00004; .00004; .0004; .0004; .00008; .002; .002; .002; .0002; .002; .
0002; .002; .002; .002; .002; .002 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g
eased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Po
VA POLLEN; CYNODON DACTYLON POLLEN; FESTUCA PRATENSIS POLLEN; PERIPLANETA AMERIC
ANA; PHLEUM PRATENSE POLLEN; SORGHUM HALEPENSE POLLEN .00008; .002; 80; 20000;
.01; 20000; .0004 g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL
],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EP
oduction [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredie
ILLUS FUMIGATUS; CARYA TOMENTOSA POLLEN; CLADOSPORIUM HERBARUM; CYNODON DACTYLON
POLLEN; DERMATOPHAGOIDES FARINAE; JUNIPERUS ASHEI POLLEN; MORUS ALBA POLLEN; MU
COR RACEMOSUS; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PLANTAGO LANCEOLATA POL
LEN; PLATANUS OCCIDENTALIS POLLEN; PLEOSPORA HERBARUM; POA PRATENSIS POLLEN; QUE
E POLLEN; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN .002; .0004; .002; 160;
.002; .0004; .002; 400; 400; .002; .002; .002; .002; .002; .002; .0004; 800; .00
2; .002; .002; .002; .002; .002 g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; [BA
U]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL;
g/mL; g/mL; g/mL; g/mL "Standardized Insect Allergenic Extract [EPC],Increased
[EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Prote
llen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Producti
on [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens
POLLEN; POPULUS DELTOIDES POLLEN; POPULUS NIGRA POLLEN; QUERCUS ALBA POLLEN; UL
MUS AMERICANA POLLEN; URTICA DIOICA POLLEN .002; .002; 800; .002; .00004; .
00004; .002; .0004; .002; .002; .002; .002; .002; .001; .002; .001; .002; .002;
.002 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/m
L; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Non-Standardized Pollen Allerge
OLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAI
R; FESTUCA PRATENSIS POLLEN; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN;
SORGHUM HALEPENSE POLLEN .002; .0004; .01; .01; 16; 400; 400; 400; 800; .
002; 800; .00008 g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; g/mL; [BAU]/m
L; [BAU]/mL; g/mL; [BAU]/mL; g/mL "Standardized Pollen Allergenic Extract
rgens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increas
PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/I
Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
BLA102223 "Antigen Laboratories, Inc." ACER NEGUNDO POLLEN; ASPERGILLUS
FUMIGATUS; BOS TAURUS HAIR; CHENOPODIUM ALBUM POLLEN; COCHLIOBOLUS SATIVUS; DER
MATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; EPICOCCUM NIGRUM; FRAXINU
S AMERICANA POLLEN; FUSARIUM OXYSPORUM; IVA ANNUA VAR. ANNUA POLLEN; JUGLANS NIG
RA POLLEN; PERIPLANETA AMERICANA; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN;
RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; ULMUS AMERICANA POLLEN .002; .0
02; .002; .002; .002; 80; 80; .002; .002; .002; .002; .002; .002; .002; .002; .0
02; .002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; g/mL; g/mL; g/mL
; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Non-Standardized Pollen
en Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production
[PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [C
Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized An
d Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fu
r [Chemical/Ingredient],Increased IgG Production [PE],Fungal Proteins [Chemical/
xtract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Non-St
l/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histami
ne Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect
redient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],S
l-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoide
s [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemica
ne Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient
ALTERNATA; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; ANTHOX
ANTHUM ODORATUM POLLEN; ASPERGILLUS FUMIGATUS; CLADOSPORIUM HERBARUM; COCHLIOBOL
US SATIVUS; EPICOCCUM NIGRUM; FRAXINUS AMERICANA POLLEN; FUSARIUM OXYSPORUM; JUG
LANS NIGRA POLLEN; LOLIUM PERENNE POLLEN; PERIPLANETA AMERICANA; PLANTAGO LANCEO
LATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALB
A POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN
; ULMUS AMERICANA POLLEN .002; .0004; .002; 4000; 4000; .002; .002; .002;
.002; .002; .002; .002; 4000; .002; .002; .002; .002; .002; .002; .002; .002; .
002 g/mL; g/mL; g/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL;
g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Non-Sta
Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [
Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingred
ient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Relea
se [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Protein
ased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemica
cal/Ingredient],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredie
EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE]"
BLA102223 "Antigen Laboratories, Inc." ACER NEGUNDO POLLEN; AGROSTIS GI
GANTEA POLLEN; ALNUS RHOMBIFOLIA POLLEN; ALTERNARIA ALTERNATA; AMARANTHUS RETROF
LEXUS POLLEN; ANTHOXANTHUM ODORATUM POLLEN; BOS TAURUS HAIR; CARYA ALBA POLLEN;
CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; COCHLIOBOLUS SATIVUS; DACT
YLIS GLOMERATA POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS;
FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; JUNI
PERUS ASHEI POLLEN; LOLIUM PERENNE POLLEN; MORUS ALBA POLLEN; PERIPLANETA AMERIC
ANA; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS P
OLLEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUME
X ACETOSELLA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERIC
ANA POLLEN .002; 571.43; .002; .002; .002; 571.43; .002; .001; .001; .002;
.002; 571.43; 16; 16; 571.43; .002; .002; .002; 571.43; .002; .002; 571.43; .002
; .002; 571.43; .002; .002; .002; .002; .002; .002 g/mL; [BAU]/mL; g/mL; g/
mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [AU]/mL; [B
AU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL;
g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Non-Standardized Pollen Allergenic Extr
Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [
Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingred
ent],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allerg
ngredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Hista
mine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Alle
RHYNCHOS FEATHER; ANSER ANSER FEATHER; CANDIDA ALBICANS; CANIS LUPUS FAMILIARIS
HAIR; CLADOSPORIUM CLADOSPORIOIDES; COCHLIOBOLUS SATIVUS; DERMATOPHAGOIDES FARIN
AE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; FUSARIUM OXYSPORUM; GALLUS
GALLUS FEATHER; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PERIPLANETA AMERICANA
; PLEOSPORA HERBARUM; RHIZOPUS STOLONIFER; SPORISORIUM CRUENTUM; USTILAGO CYNODO
NTIS .00008; .00003; .00003; .002; .00008; .002; .002; 16; 400; 400; .002; .0
mL; g/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL;
g/mL "Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine R
redient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histami
hemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Alle
],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens
[Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increase
E],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardiz
ed Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediat
ed Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],
E],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemica
ergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Productio
-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],N
BLA102223 "Antigen Laboratories, Inc." AMBROSIA ARTEMISIIFOLIA POLLEN;
AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; BETULA NIGRA POLLEN; CARY
A ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AME
RICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; KOCHIA
SCOPARIA POLLEN; PLANTAGO LANCEOLATA POLLEN; POA PRATENSIS POLLEN; POPULUS DELTO
IDES POLLEN; QUERCUS ALBA POLLEN .000027; .000027; .000027; .002; .001; .
001; 16; .002; .00008; .00008; .002; .002; 4000; .002; .002 g/mL; g/mL; g/mL
; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL
E],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
A POLLEN; CANIS LUPUS FAMILIARIS HAIR; CARYA ALBA POLLEN; CARYA ILLINOINENSIS PO
LLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN;
JUNIPERUS VIRGINIANA POLLEN; MORUS RUBRA POLLEN; PERIPLANETA AMERICANA; PLATANUS
OCCIDENTALIS POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES POLLEN; POPULUS NIG
RA POLLEN; SALIX NIGRA POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN
.002; .002; .002; .0002; .0002; 400; .002; .002; .002; .002; .002; .002; .001; .
0004; .001; .002; .002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/
mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Standardized Po
s [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],In
ion [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardi
ed Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredi
gredient]"
ARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS
NIGRA POLLEN; JUNIPERUS VIRGINIANA POLLEN; MORUS RUBRA POLLEN; PLATANUS OCCIDEN
TALIS POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES POLLEN; POPULUS NIGRA POLLE
N; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALIX NIGRA POLLEN; ULMUS AMERI
CANA POLLEN; URTICA DIOICA POLLEN .002; .002; 4000; .002; .001; .001; .002
; .002; .002; .002; .002; .001; .002; .001; .002; .002; .002; .002; .002
enic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pol
len [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/I
RHYNCHOS FEATHER; ANSER ANSER FEATHER; ASPERGILLUS FUMIGATUS; AVENA SATIVA POLLE
N; CANIS LUPUS FAMILIARIS HAIR; CLADOSPORIUM HERBARUM; COCHLIOBOLUS SATIVUS; CYN
ODON DACTYLON POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; GALLUS G
ALLUS FEATHER; PASCOPYRUM SMITHII POLLEN; PERIPLANETA AMERICANA; PHLEUM PRATENSE
POLLEN; SORGHUM HALEPENSE POLLEN .002; .00067; .00067; .002; .002; .002;
.002; .002; 80; 400; 400; .00067; .002; .002; 4000; .002 g/mL; g/mL; g/mL
; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; [
BAU]/mL; g/mL "Standardized Pollen Allergenic Extract [EPC],Increased Histamin
[Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair A
[PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemi
cal/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standar
-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],
Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC]
uction [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient
],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],
Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophago
ides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chem
gens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Inc
reased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ing
redient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Ext
d IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredi
se [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Ch
emical/Ingredient]"
BLA102223 "Antigen Laboratories, Inc." ACER NEGUNDO POLLEN; BETULA NIGR
A POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; FRAXINUS AMERICANA POLL
EN; JUGLANS NIGRA POLLEN; JUNIPERUS VIRGINIANA POLLEN; MORUS RUBRA POLLEN; PLATA
NUS OCCIDENTALIS POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES POLLEN; POPULUS
NIGRA POLLEN; QUERCUS ALBA POLLEN; SALIX NIGRA POLLEN; ULMUS AMERICANA POLLEN
.005; .005; .00004; .00004; .002; .002; .002; .002; .005; .0025; .002; .0025; .0
05; .005; .005 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL
; g/mL; g/mL; g/mL; g/mL "Non-Standardized Pollen Allergenic Extract [EPC
edient]"
RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AVENA SATIVA POLLEN; CANIS
LUPUS FAMILIARIS HAIR; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; FELIS
CATUS HAIR; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOLA
TA POLLEN; RUMEX ACETOSELLA POLLEN; URTICA DIOICA POLLEN .0004; .002; 200
00; .002; .002; .002; 400; 2000; .002; 800; .0004; .01; .002 g/mL; g/mL; [AU]
/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL
stamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allerge
n [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
BLA102223 "Antigen Laboratories, Inc." BOS TAURUS HAIR; CANIS LUPUS FAM
ILIARIS HAIR; EQUUS CABALLUS HAIR; FELIS CATUS HAIR; ODOCOILEUS VIRGINIANUS HAIR
; ORYCTOLAGUS CUNICULUS HAIR; PASCOPYRUM SMITHII POLLEN .002; .002; .00008; 2000
; .01; .01; .002 g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL "Non-Sta
],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [E
roduction [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Sali
vary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Al
PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/
Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Hist
amine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur
[Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal H
nity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Che
mical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Stand
ll-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingr
edient],Fur [Chemical/Ingredient]"
N; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALIX NIGRA POLLEN; ULMUS AMERI
CANA POLLEN; URTICA DIOICA POLLEN .002; .00008; 160; .002; .00004; .00004;
.002; .002; .0004; .002; .002; .001; .002; .001; .002; .002; .002; .002; .002
OLLEN; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; FESTUCA PRATENSIS POLLE
N; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN; SORGHUM HALEPENSE POLLEN
.00008; .002; .005; .005; 400; 1000; 400; 10000; .005; 4000; .002 g/mL; g/
mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [BAU]/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL
ll-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredi
ent],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/In
gredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histam
ine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [
Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allerge
ncreased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],In
sect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standard
edient]"
VA POLLEN; PHLEUM PRATENSE POLLEN; PLATANUS OCCIDENTALIS POLLEN .002; .002; 4000
; .01 g/mL; g/mL; [BAU]/mL; g/mL "Non-Standardized Pollen Allergenic Extr
],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],
RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AVENA SATIVA POLLEN; CANIS
LUPUS FAMILIARIS HAIR; COCHLIOBOLUS SATIVUS; CYNODON DACTYLON POLLEN; DERMATOPHA
GOIDES PTERONYSSINUS; FELIS CATUS HAIR; FESTUCA PRATENSIS POLLEN; JUNIPERUS VIRG
INIANA POLLEN; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN; PLANTAGO LANCE
OLATA POLLEN; RUMEX ACETOSELLA POLLEN; SORGHUM HALEPENSE POLLEN .002; .002; 800;
.0004; .005; .005; 1000; 1000; 400; 4000; .0004; .002; 800; .005; .002; .002
g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [BAU]/mL; [BAU]/mL; g/
mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL "Standardized Pollen Allergenic Extract
t [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Che
dient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [
PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histami
ne Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic E
ent],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Relea
se [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemic
al/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [C
hemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increa
[PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Inse
MBROSIA ARTEMISIIFOLIA POLLEN; AVENA SATIVA POLLEN; CARYA ALBA POLLEN; CARYA ILL
INOINENSIS POLLEN; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; FELI
S CATUS HAIR; FESTUCA PRATENSIS POLLEN; JUGLANS NIGRA POLLEN; MORUS RUBRA POLLEN
; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN; PLATANUS OCCIDENTALIS POLLE
N; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SORGH
UM HALEPENSE POLLEN; URTICA DIOICA POLLEN .002; 4000; .00008; .00004; .000
04; 16; 400; 400; 160; .002; .002; .00008; 160; .002; .002; .002; .002; .00008;
.002 g/mL; [AU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [BAU]/mL; [BAU]/mL;
g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Non-Standardize
andardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased
IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [P
E],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],
ergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],I
tion [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary
Proteins and Peptides [Chemical/Ingredient],Standardized Insect Allergenic Extra
eins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Poll
N; QUERCUS ALBA POLLEN; SALIX NIGRA POLLEN; ULMUS AMERICANA POLLEN .002; .0
02; 4000; .002; .00004; .00004; .002; .0004; .002; .002; .002; .005; .002; .005;
.00008; .002; .002 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL;
g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Non-Standardized Pollen Allerge
ction [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
S FUMIGATUS; AVENA SATIVA POLLEN; CANIS LUPUS FAMILIARIS HAIR; CLADOSPORIUM HERB
ARUM; COCHLIOBOLUS SATIVUS; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES PTERONYSSI
NUS; FELIS CATUS HAIR; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN
.0004; .005; .00008; .005; .005; .002; 400; 1000; 400; .002; 160 g/mL; g/
mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [BAU]/mL; g/mL; [BAU]/mL "Standar
iated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],A
llergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredie
nt],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Re
lease [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemic
Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC]
,Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [C
],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
S FUMIGATUS; AVENA SATIVA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN;
COCHLIOBOLUS SATIVUS; DERMATOPHAGOIDES PTERONYSSINUS; JUGLANS NIGRA POLLEN; MOR
US RUBRA POLLEN; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN; QUERCUS ALBA
POLLEN .002; .005; .00008; .001; .001; .005; 1000; .005; .005; .002; 160; .005
g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL
RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; CANIS LUPUS FAMILIARIS HAIR
; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; EQUUS CABALLUS HAIR; FELIS CATU
S HAIR; FESTUCA PRATENSIS POLLEN; JUNIPERUS VIRGINIANA POLLEN; PASCOPYRUM SMITHI
I POLLEN; PHLEUM PRATENSE POLLEN .005; .005; 160; .005; .0002; .0002; .00
008; 400; 4000; .00008; .002; 10000 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g
/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL "Non-Standardized Pollen Allerge
hemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair All
E],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemica
l/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardi
ediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Al
ngredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergen
creased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingred
ient]"
POLLEN .00008; .00008; 160; .00008; .00004; .00004; .002; .00008; .00008; .0000
8; .00008; .0004; .0004; .001; .0004; .001; .00008; .002; .0004; .0004; .0004
BLA102223 "Antigen Laboratories, Inc." AVENA SATIVA POLLEN; CYNODON DAC
TYLON POLLEN; FESTUCA PRATENSIS POLLEN; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATEN
SE POLLEN; SORGHUM HALEPENSE POLLEN .00008; 80; 160; .0004; 160; .00008
g/mL; [BAU]/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL "Standardized Pollen Allergenic
/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extr
SATIVA POLLEN; BETULA POPULIFOLIA POLLEN; FELIS CATUS HAIR; FESTUCA PRATENSIS PO
LLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; MORUS RUBRA POLLEN; PASCO
PYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATAN
US OCCIDENTALIS POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES POLLEN; POPULUS N
IGRA POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; ULMUS AMERICANA POLLE
N .002; .002; .002; 800; .002; .002; 400; 800; .002; .002; .002; .002; 160
; .002; .002; .001; .002; .001; .002; .002; .002 g/mL; g/mL; g/mL; [AU]/m
L; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL;
POLLEN .0004; .00008; 160; .002; .00004; .00004; .0004; .00008; .0004; .0004; .
00008; .00008; .00008; .001; .0004; .001; .002; .00008; .002; .002; .002
BLA102223 "Antigen Laboratories, Inc." AVENA SATIVA POLLEN; CANIS LUPUS
FAMILIARIS HAIR; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAG
OIDES PTERONYSSINUS; FELIS CATUS HAIR; FESTUCA PRATENSIS POLLEN; PASCOPYRUM SMIT
HII POLLEN; PHLEUM PRATENSE POLLEN; SORGHUM HALEPENSE POLLEN .0004; .002; 16;
16; 16; 400; 160; .0004; 160; .00008 g/mL; g/mL; [BAU]/mL; [AU]/mL; [AU]/mL;
[BAU]/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL "Standardized Pollen Allergenic
ngredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic E
sed IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredi
ent],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Anima
BLA102223 "Antigen Laboratories, Inc." ASPERGILLUS FUMIGATUS; DERMATOPH
AGOIDES FARINAE; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM .01; 2000; .01
g/mL; [AU]/mL; g/mL "Standardized Insect Allergenic Extract [EPC],Increased
elease [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Al
49288-0925_01ea9b64-5114-40fc-a417-019ec52aa574 49288-0925 NON-STANDARDIZED
POPULIFOLIA POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; FESTUCA P
RATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; JUNIPERUS VIRGINIANA POLLEN; MORUS R
UBRA POLLEN; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOL
ATA POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; SORGHUM HALEPENSE POL
LEN; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN .0004; .0004; 4000; .000
4; .002; .002; 16; 4000; .002; .0004; .002; .002; 160; .002; .002; .002; .002; .
002; .002 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL;
g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Non-Standardize
],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],
AVENA SATIVA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CYNODON DACT
YLON POLLEN; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; PASCOPYRUM SMI
THII POLLEN; PHLEUM PRATENSE POLLEN; RUMEX ACETOSELLA POLLEN; SORGHUM HALEPENSE
POLLEN 20000; .00008; .005; .005; 400; 800; .0004; .00008; 160; .01; .00008
[AU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL
"Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],In
creased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Rel
ease [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract
A POLLEN; BETULA POPULIFOLIA POLLEN; CANIS LUPUS FAMILIARIS HAIR; CARYA ALBA POL
LEN; CARYA ILLINOINENSIS POLLEN; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES PTERO
NYSSINUS; EQUUS CABALLUS HAIR; FELIS CATUS HAIR; FESTUCA PRATENSIS POLLEN; FRAXI
NUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; MORUS RUBRA POLLEN; PASCOPYRUM SMITH
II POLLEN; PERIPLANETA AMERICANA; PHLEUM PRATENSE POLLEN; PLATANUS OCCIDENTALIS
POLLEN; POPULUS DELTOIDES POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLL
EN .002; .002; .002; .002; .001; .001; 400; 400; .00008; 400; 4000; .002; .
002; .002; .002; .002; 4000; .002; .002; .002; .002 g/mL; g/mL; g/mL; g/mL;
g/mL; g/mL; [BAU]/mL; [AU]/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL;
g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL "Standardized Pollen Allergenic Extract
n [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect
[PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allerg
ens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased
],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ing
c Extract [EPC]"
LBUM POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA P
OLLEN; JUNIPERUS VIRGINIANA POLLEN; MORUS RUBRA POLLEN; PASCOPYRUM SMITHII POLLE
N; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POL
LEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES POLLEN; POPULUS NIGRA POLLEN; QUERCU
S ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALIX NIGRA POLLEN; SORGHUM HALEPENSE PO
LLEN; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN .0004; .00008; 160; .000
4; .0004; .00004; .00004; .0004; 16; .00008; .0004; .0004; .0004; .002; 4000; .0
02; .002; .001; .00008; .001; .0004; .00008; .0004; .0004; .0004; .002 g/mL; g/
mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/m
L; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL
S FUMIGATUS; CANIS LUPUS FAMILIARIS HAIR; DERMATOPHAGOIDES FARINAE; DERMATOPHAGO
IDES PTERONYSSINUS; FELIS CATUS HAIR .00008; .01; .002; 16; 80; 16 g/mL; g/
mL; g/mL; [AU]/mL; [AU]/mL; [BAU]/mL "Standardized Animal Hair Allergenic Ext
emical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histam
ine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antig
ens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient
],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],I
stamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingre
RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN
; AMBROSIA TRIFIDA POLLEN; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; CAND
IDA ALBICANS; CANIS LUPUS FAMILIARIS HAIR; CARYA ALBA POLLEN; CARYA ILLINOINENSI
S POLLEN; COCHLIOBOLUS SATIVUS; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINA
E; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; FRAXINUS AMERICANA POLLEN;
GALLUS GALLUS FEATHER; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN;
KOCHIA SCOPARIA POLLEN; PERIPLANETA AMERICANA; PLEOSPORA HERBARUM; POA PRATENSI
S POLLEN; RHIZOPUS STOLONIFER; RUMEX ACETOSELLA POLLEN; SORGHUM HALEPENSE POLLEN
; SPORISORIUM CRUENTUM; ULMUS AMERICANA POLLEN; USTILAGO CYNODONTIS .00008;
.002; .000027; .000027; .000027; .00067; .00067; .002; .0004; .00004; .00004; .0
02; 400; 16; 16; 80; .0004; .00067; .002; .00008; .002; .002; .002; 160; .002; .
g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL;
g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Non-Sta
ngredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extrac
gG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Prote
ins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Al
t],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Sta
-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredi
[EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Ch
emical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Alle
],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardize
dient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG
ase [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Re
nd Peptides [Chemical/Ingredient]"
POLLEN .0004; .0004; 4000; .00008; .00004; .00004; .002; .0004; .00008; .0004;
.00008; .0004; .0004; .001; .00008; .001; .00008; .002; .002; .0004; .0004
stamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen All
ity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardiz
TYLON POLLEN; FESTUCA PRATENSIS POLLEN; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATEN
SE POLLEN; SORGHUM HALEPENSE POLLEN .00008; 16; 800; .0004; 800; .00008
g/mL; [BAU]/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL "Standardized Pollen Allergenic
49288-0933_6e25c8e0-c526-446a-ae3c-33c3078f6714 49288-0933 NON-STANDARDIZED
POLLEN .0004; .002; 800; .002; .0002; .0002; .002; .002; .0004; .00008; .002; .
002; .0004; .0002; .0004; .0002; .00008; .002; .002; .002; .002 g/mL; g/mL; [AU]
emical/Ingredient]"
TYLON POLLEN; FESTUCA PRATENSIS POLLEN; PASCOPYRUM SMITHII POLLEN; PERIPLANETA A
MERICANA; PHLEUM PRATENSE POLLEN; SORGHUM HALEPENSE POLLEN .00008; 16; 160;
.0004; .002; 160; .00008 g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL;
g/mL "Standardized Pollen Allergenic Extract [EPC],Increased Histamine Releas
t],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release
[PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [
MBROSIA ARTEMISIIFOLIA POLLEN; AVENA SATIVA POLLEN; BETULA POPULIFOLIA POLLEN; C
ARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS
AMERICANA POLLEN; MORUS RUBRA POLLEN; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE
POLLEN; POPULUS ALBA POLLEN; POPULUS NIGRA POLLEN; SORGHUM HALEPENSE POLLEN; UL
MUS AMERICANA POLLEN .002; 4000; .002; .005; .001; .001; 400; .005; .002; .00
2; 4000; .0025; .0025; .002; .005 g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; [
BAU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL "Non-Standardize
Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Stan
S FAMILIARIS HAIR; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; COCHLIOBOLUS S
ATIVUS; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; JUNIPERUS VIRGINIAN
A POLLEN; MORUS RUBRA POLLEN; PERIPLANETA AMERICANA; PHLEUM PRATENSE POLLEN; PLA
NTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN
.005; .005; .001; .001; .0004; 10000; .005; .0004; .002; .005; 4000; .0004; .005
; .002 g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL
ollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Ani
Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens
[Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increase
E],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Sta
SATIVA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; COCHLIOBOLUS SATIV
US; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; FESTUCA PRATENSIS P
OLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS VIRGINIANA POL
LEN; MORUS RUBRA POLLEN; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN; PLAT
ANUS OCCIDENTALIS POLLEN; QUERCUS ALBA POLLEN; SORGHUM HALEPENSE POLLEN .002; .0
02; .002; 800; .002; .001; .001; .002; 400; 400; 4000; .002; .002; .002; .002; .
002; 4000; .002; .002; .002 g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/m
L; [BAU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/
PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Po
llen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect A
[PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredie
nt],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-St
]"
BLA102223 "Antigen Laboratories, Inc." COCHLIOBOLUS SATIVUS; DERMATOPHA
GOIDES PTERONYSSINUS; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM .0004; 400; .002
g/mL; [AU]/mL; g/mL "Standardized Insect Allergenic Extract [EPC],Increased
teins [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
BLA102223 "Antigen Laboratories, Inc." AMARANTHUS RETROFLEXUS POLLEN; B
ETULA ALLEGHANIENSIS POLLEN; BETULA LENTA POLLEN; BETULA NIGRA POLLEN; BETULA OC
CIDENTALIS POLLEN; BETULA PAPYRIFERA POLLEN; BETULA POPULIFOLIA POLLEN; CHENOPOD
IUM ALBUM POLLEN; IVA ANNUA VAR. ANNUA POLLEN; IVA XANTHIFOLIA POLLEN; KOCHIA SC
OPARIA POLLEN; PHLEUM PRATENSE POLLEN; QUERCUS ALBA POLLEN; QUERCUS RUBRA POLLEN
; QUERCUS VIRGINIANA POLLEN; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN; SALS
OLA KALI POLLEN; SORGHUM HALEPENSE POLLEN .002; .00167; .00167; .00167; .0
0167; .00167; .00167; .002; .001; .001; .002; 160; .0033; .0033; .0033; .001; .0
mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Non-Standardize
C],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical
c Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen
[Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingr
gredient]"
BLA102223 "Antigen Laboratories, Inc." FELIS CATUS HAIR; PHLEUM PRATENS
E POLLEN; QUERCUS RUBRA POLLEN 304.04; 10000; .01 [BAU]/mL; [BAU]/mL; g/mL
gredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Ex
ed IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredie
nt],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Pollen All
l/Ingredient]"
A POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES P
OLLEN; POPULUS NIGRA POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALIX
NIGRA POLLEN; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN .002; .002; 800;
.002; .001; .001; .002; .002; .002; .002; .002; .002; .001; .002; .001; .00008;
.002; .002; .002; .002 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL;
tract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Ch
emical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredie
OLLEN; FELIS CATUS HAIR; FESTUCA PRATENSIS POLLEN; PASCOPYRUM SMITHII POLLEN; PH
LEUM PRATENSE POLLEN; SORGHUM HALEPENSE POLLEN .002; .00008; .002; .002; 16; 40
0; 800; .002; 160; .0004 g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; [BAU
]/mL; g/mL; [BAU]/mL; g/mL "Standardized Animal Hair Allergenic Extract [EP
n [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized
49288-0943_57885b81-24e5-4a64-8d65-8a6517157bd9 49288-0943 NON-STANDARDIZED
BLA102223 "Antigen Laboratories, Inc." ALTERNARIA ALTERNATA; AMBROSIA A
RTEMISIIFOLIA POLLEN; ASPERGILLUS FUMIGATUS; BETULA POPULIFOLIA POLLEN; CANIS LU
PUS FAMILIARIS HAIR; COCHLIOBOLUS SATIVUS; CYNODON DACTYLON POLLEN; DERMATOPHAGO
IDES PTERONYSSINUS; FESTUCA PRATENSIS POLLEN; PASCOPYRUM SMITHII POLLEN; PERIPLA
NETA AMERICANA; PHLEUM PRATENSE POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES P
OLLEN; POPULUS NIGRA POLLEN; ULMUS AMERICANA POLLEN .002; 4000; .002; .002;
.002; .002; 400; 400; 4000; .002; .002; 4000; .001; .002; .001; .002 g/mL; [A
U]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL
; g/mL; g/mL; g/mL; g/mL "Standardized Pollen Allergenic Extract [EPC],In
,Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized A
ed Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allerge
ns [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increa
[PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Stand
diated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [C
hemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/In
nity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],
al/Ingredient]"
RHYNCHOS FEATHER; ANSER ANSER FEATHER; ASPERGILLUS FUMIGATUS; AUREOBASIDIUM PULL
ULANS VAR. PULLUTANS; CANDIDA ALBICANS; CANIS LUPUS FAMILIARIS HAIR; CLADOSPORIU
M CLADOSPORIOIDES; COCHLIOBOLUS SATIVUS; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOI
DES PTERONYSSINUS; FELIS CATUS HAIR; GALLUS GALLUS FEATHER; PERIPLANETA AMERICAN
A; PLEOSPORA HERBARUM; RHIZOPUS STOLONIFER; USTILAGO AVENAE; USTILAGO MAYDIS; US
TILAGO NUDA HORDEI; USTILAGO TRITICI .00008; .00013; .00013; .002; .00008; .0
0008; .00008; .002; .00008; 80; 16; 16; .00013; .00008; .0004; 10.00008; .0005;
.0005; .0005; .0005 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [A
U]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL
Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic E
sed IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemica
ine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feath
Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],F
dized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Stand
diated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/I
IgG Production [PE],Fungal Proteins [Chemical/Ingredient]"
BLA102223 "Antigen Laboratories, Inc." ACER NEGUNDO POLLEN; AMBROSIA AR
TEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; BETU
LA NIGRA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBU
M POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANN
UA POLLEN; JUNIPERUS VIRGINIANA POLLEN; PLANTAGO LANCEOLATA POLLEN; POA PRATENSI
S POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN
; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN .00008; .000027; .000027
; .000027; .00008; .00004; .00004; .002; 16; .00008; .002; .00008; .00008; 160;
; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL
ns [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-m
,Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardiz
n [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
VA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; COCHLIOBOLUS SATIVUS;
CYNODON DACTYLON POLLEN; FUSARIUM OXYSPORUM; JUNIPERUS VIRGINIANA POLLEN; PASCOP
YRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN .002; .0004; .001; .001; .002; 8
0; .01; .01; .0004; 160 g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL
; [BAU]/mL "Standardized Pollen Allergenic Extract [EPC],Increased Histamin
LBUM POLLEN; CYNODON DACTYLON POLLEN; FELIS CATUS HAIR; FESTUCA PRATENSIS POLLEN
; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; MORUS RUBRA POLLEN; PASCOPYRU
M SMITHII POLLEN; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS O
CCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSE
LLA POLLEN; SALIX NIGRA POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN
; URTICA DIOICA POLLEN .002; .00008; 800; .00008; .0004; .0002; .0002; .0004; 8
0; 400; 4000; .002; .0004; .0004; .0004; 4000; .002; .00008; .0004; .00008; .000
4; .002; .002; .002; .0004 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/m
L; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g
/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Non-Standardized Pollen Allergenic Extr
lergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE]
,Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemic
redient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine R
on [PE],Pollen [Chemical/Ingredient]"
S FUMIGATUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; CANIS LUPUS FAMILIARIS HAIR
; CLADOSPORIUM CLADOSPORIOIDES; COCHLIOBOLUS SATIVUS; DERMATOPHAGOIDES FARINAE;
DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; FUSARIUM OXYSPORUM; PENICILLIU
M CHRYSOGENUM VAR. CHRYSOGENUM; PERIPLANETA AMERICANA; PHOMA DESTRUCTIVA; PLEOSP
ORA HERBARUM; RHIZOPUS STOLONIFER; SPORISORIUM CRUENTUM; USTILAGO AVENAE; USTILA
GO CYNODONTIS; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI .0004; .
00008; .0004; .002; .0004; .0004; 16; 16; 16; .0004; .0004; .002; .002; .0004; .
mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL;
g/mL; g/mL; g/mL; g/mL "Standardized Animal Hair Allergenic Extract [EPC],Incre
eins and Peptides [Chemical/Ingredient],Standardized Insect Allergenic Extract [
ted Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingred
mmunity [PE]"
RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN
; AMBROSIA TRIFIDA POLLEN; BETULA NIGRA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOI
NENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; FRAXINUS AMERICANA POLLEN; IVA ANNUA VA
R. ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; KOCHIA SCOPARIA POLLEN; PLANTAGO L
ANCEOLATA POLLEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA P
OLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; U
LMUS AMERICANA POLLEN .0004; .002; .000027; .000027; .000027; .00008; .0002; .
0002; .002; .00008; .002; .00008; .002; .00008; 160; .00008; .00008; .0004; .002
; .0004; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL
; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Non-Sta
tandardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE]"
RETROFLEXUS POLLEN; ASPERGILLUS FUMIGATUS; AVENA SATIVA POLLEN; CANIS LUPUS FAM
ILIARIS HAIR; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; DERMATOPHAGOIDES PT
ERONYSSINUS; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDE
NTALIS POLLEN; QUERCUS ALBA POLLEN .002; .002; .002; .002; .01; .001; .001;
2000; 4000; .01; .002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/m
L; [BAU]/mL; g/mL; g/mL; g/mL "Non-Standardized Pollen Allergenic Extract [EPC
Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Ch
POPULIFOLIA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CYNODON DACTY
LON POLLEN; FELIS CATUS HAIR; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; M
ORUS RUBRA POLLEN; PERIPLANETA AMERICANA; PHLEUM PRATENSE POLLEN; PLATANUS OCCID
ENTALIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA
POLLEN; SORGHUM HALEPENSE POLLEN .002; .002; 4000; .002; .002; .001; .001
; 400; 400; .002; .002; .002; .002; 4000; .002; .002; .0004; .002; .002 g/mL; g/
mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL;
[BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Non-Standardized Pollen Allergenic Extr
redient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity
mine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic
l/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergeni
reased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingr
edient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized In
AMBROSIA TRIFIDA POLLEN; PHLEUM PRATENSE POLLEN; QUERCUS ALBA POLLEN; QUERCUS RU
BRA POLLEN; QUERCUS VIRGINIANA POLLEN; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS PO
LLEN; SORGHUM HALEPENSE POLLEN .005; .005; 20000; .0033; .0033; .0033; .005; .0
05; .01 g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Non-Sta
],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],I
tandardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increase
d IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [
PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [
nt]"
ALTERNATA; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; ANAS P
LATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; ASPERGILLUS FUMIGATUS; BOS TAURUS HAI
R; CANIS LUPUS FAMILIARIS HAIR; COCHLIOBOLUS SATIVUS; EQUUS CABALLUS HAIR; FELIS
CATUS HAIR; FESTUCA PRATENSIS POLLEN; GALLUS GALLUS FEATHER; MORUS RUBRA POLLEN
; ODOCOILEUS VIRGINIANUS HAIR; ORYCTOLAGUS CUNICULUS HAIR; PASCOPYRUM SMITHII PO
LLEN; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; POPULUS DELTOIDES POLL
EN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; ULMUS AMERICANA POLLEN
.002; .002; .002; 4000; .00067; .00067; .002; .002; .002; .002; .002; 400; 4000;
.00067; .002; .002; .002; .002; 4000; .002; .002; .002; .002; .002 g/mL; g/
mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL;
g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Non-Sta
C],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical
lease [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extrac
,Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingr
/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased His
r [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal
ased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemica
Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized An
d Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergen
s [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increa
[PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standard
ized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-medi
ated Immunity [PE],Feathers [Chemical/Ingredient]"
A POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELT
OIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALIX NIGRA POLLEN;
ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN .002; .0004; 4000; .002; .00004;
.00004; .002; .00008; .002; .002; .002; .002; .002; .002; .002; .0004; .0004; .
002; .002 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g
/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Non-Standardized Pollen
ized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG P
roduction [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],All
]"
VA POLLEN; COCHLIOBOLUS SATIVUS; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES PTERO
NYSSINUS; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN; SORGHUM HALEPENSE P
OLLEN .01; .002; .01; 400; 2000; .002; 4000; .002 g/mL; g/mL; g/mL; [BAU]/
mL; [AU]/mL; g/mL; [BAU]/mL; g/mL "Standardized Pollen Allergenic Extract
MBROSIA ARTEMISIIFOLIA POLLEN; AVENA SATIVA POLLEN; CARYA ALBA POLLEN; CARYA ILL
INOINENSIS POLLEN; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; FELI
S CATUS HAIR; FESTUCA PRATENSIS POLLEN; PASCOPYRUM SMITHII POLLEN; PERIPLANETA A
MERICANA; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTA
LIS POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALIX NIGRA POLLEN; SO
RGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN .002; 800; .0004; .001; .001; 40
0; 400; 400; 4000; .002; .002; 4000; .002; .002; .002; .002; .002; .002; .002
g/mL; [AU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/
mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL "Non-Standardized Pollen
ed Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Pro
duction [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Aller
Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased
],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins
and Peptides [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [
Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingred
BLA102223 "Antigen Laboratories, Inc." ACER NEGUNDO POLLEN; BETULA POPU
LIFOLIA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; EQUUS CABALLUS HA
IR; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS VIRGINIANA POLLEN
; MORUS RUBRA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS ALBA POLLEN; POPULUS
DELTOIDES POLLEN; POPULUS NIGRA POLLEN; QUERCUS ALBA POLLEN; SALIX NIGRA POLLEN
; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN .002; .00008; .001; .001; .002;
.002; .002; .002; .002; .002; .001; .002; .001; .0004; .002; .002; .002 g/mL; g/
; g/mL; g/mL "Non-Standardized Pollen Allergenic Extract [EPC],Increased Hist
,Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract
G Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient]"
A POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELT
OIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; ULMUS AMERICANA POLL
EN; URTICA DIOICA POLLEN .0004; .00008; 4000; .00008; .00004; .00004; .00
2; .0004; .002; .002; .0004; .002; .002; .0004; .00008; .000008; .0004; .002
ical/Ingredient]"
S FUMIGATUS; AVENA SATIVA POLLEN; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES PTER
ONYSSINUS; FELIS CATUS HAIR; FESTUCA PRATENSIS POLLEN; PASCOPYRUM SMITHII POLLEN
; PHLEUM PRATENSE POLLEN; SORGHUM HALEPENSE POLLEN .005; .005; .002; 400; 1
000; 16; 4000; .002; 160; .005 g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [BAU]/mL; [
BAU]/mL; g/mL; [BAU]/mL; g/mL "Standardized Pollen Allergenic Extract [EPC],In
gens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Inc
on [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Pr
oteins and Peptides [Chemical/Ingredient],Standardized Insect Allergenic Extract
G Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Protei
eased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemic
49288-9932_60ce9c8c-5855-42da-91ee-8bfe8edf51ab 49288-9932 HUMAN PRESCRIPTI
ON DRUG Sterile Diluent for Allergenic Extract Glycerine and Phenol
BLA BLA102223 "Antigen Laboratories, Inc." GLYCERIN; PHENOL
.1; .004 mL/mL; mL/mL "Non-Standardized Chemical Allergen [EPC],Increa
[PE],Allergens [Chemical/Ingredient],Glycerol [Chemical/Ingredient]"
ON DRUG Sterile Diluent for Allergenic Extract Phenol "INJECTION, SOLU
3 "Antigen Laboratories, Inc." PHENOL 0.004 mL/mL
ON DRUG Sterile Diluent for Allergenic Extract Human Albumin and Phenol
BLA BLA102223 "Antigen Laboratories, Inc." ALBUMIN (HUMAN); PHENOL
.0003; .004 mL/mL; mL/mL "Human Serum Albumin [EPC],Increased Intravascul
ar Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albu
min [Chemical/Ingredient]"
ON DRUG Sterile Diluent for Allergenic Extract Glycerine "INJECTI
BLA102223 "Antigen Laboratories, Inc." GLYCERIN 0.5 mL/mL
"Non-Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-
ent],Glycerol [Chemical/Ingredient]"
ON DRUG Sterile Diluent for Allergenic Extract Glycerine and Phenol
BLA BLA102223 "Antigen Laboratories, Inc." GLYCERIN; PHENOL
.25; .004 mL/mL; mL/mL "Non-Standardized Chemical Allergen [EPC],Increa
[PE],Allergens [Chemical/Ingredient],Glycerol [Chemical/Ingredient]"
50007-1000_062f4b65-ebd4-4dd5-a3ba-3e7c1995c8ae 50007-1000 HUMAN OTC DRUG
Lactovit Original Roll-On Antiperspirant Deodorant Aluminum Chloroh
ydrate LIQUID TOPICAL 20091216 OTC MONOGRAPH FINAL part350
"Antonio Puig, S.A." ALUMINUM CHLOROHYDRATE 15 mL/100mL
50007-2000_0a4436d5-8d69-4a97-bec2-16b378a9334c 50007-2000 HUMAN OTC DRUG
Lactovit Sensitive Skin Roll-On Antiperspirant Deodorant Aluminum
Chlorohydrate LIQUID TOPICAL 20091216 OTC MONOGRAPH FINAL
part350 "Antonio Puig, S.A." ALUMINUM CHLOROHYDRATE 10 mL/100mL
50007-3000_bb3c62cb-a3de-4296-a8fc-129da58170eb 50007-3000 HUMAN OTC DRUG
Lactovit Men Roll-On Antiperspirant Deodorant Aluminum Chlorohydrate
LIQUID TOPICAL 20091216 OTC MONOGRAPH FINAL part350 "Antonio
Puig, S.A." ALUMINUM CHLOROHYDRATE 15 mL/100mL
50970-001_ac8d5688-c210-4410-8e27-5816216a8074 50970-001 HUMAN OTC DRUG
e-HCG Fat Release System "arginine, acetylcarnitine, l-, ornithine and hu
man chorionic gonadotropin" LIQUID ORAL 20100819 UNAPPROV
ED HOMEOPATHIC AnuMed International LLC "ACETYLCARNITINE, L-; AR
GININE; HUMAN CHORIONIC GONADOTROPIN; ORNITHINE" 30; 30; 60; 30 [hp_X]/3
0mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL
50970-002_6b613a6f-64cc-4cda-88c4-27e839cc5e43 50970-002 HUMAN OTC DRUG
e-HGH hGH somatropin LIQUID ORAL 20110501 UNAPPROV
ED HOMEOPATHIC AnuMed International LLC SOMATROPIN 6
[hp_C]/200mL
50970-003_1049d373-8b88-49fa-a4ca-8461e8b24247 50970-003 HUMAN OTC DRUG
IGF-1 Endurance Plus insulin-like growth factor-1 (IGF-1) LIQUID
ORAL 20110501 UNAPPROVED HOMEOPATHIC AnuMed Internati
onal LLC MECASERMIN 30 [hp_C]/30mL
53152-1004_5f6fcb2b-aa3b-47bb-b6e1-c82ba6779676 53152-1004 HUMAN OTC DRUG
Instant Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20120828
OTC MONOGRAPH NOT FINAL part333E "AOSS Medical Supply, Inc." ALCOHOL
62 mL/100mL
53152-1008_8215e149-2384-4ce8-9d87-50763df93da8 53152-1008 HUMAN OTC DRUG
Instant Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20120828
OTC MONOGRAPH NOT FINAL part333E "AOSS Medical Supply, Inc." ALCOHOL
62 mL/100mL
40092-500_853c97f1-62b0-451e-ac02-dd23115bb486 40092-500 HUMAN OTC DRUG
GOLDSHIELD 24 GS 24 BENZALKONIUM CHLORIDE SOLUTION TOPICAL 20111216
OTC MONOGRAPH NOT FINAL part333A AP GOLDSHIELD LLC BENZALKONIUM CHL
ORIDE 0.001 g/g
40092-600_97d5938f-b627-4a86-bf0b-4ac50b708725 40092-600 HUMAN OTC DRUG
VETERAN SHIELD 24 VSH BENZALKONIUM CHLORIDE SOLUTION TOPICAL
20120615 OTC MONOGRAPH NOT FINAL part333A AP GOLDSHIELD LL
C BENZALKONIUM CHLORIDE 0.001 g/g
15338-150_31999703-3b31-4820-9319-1e5675c1ad82 15338-150 HUMAN PRESCRIPTI
NDA NDA070033 Apace Packaging METRONIDAZOLE 500 mg/1 "Nitroim
idazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient]"
15338-170_3a1b39df-bc52-4ad7-87f6-ea77cac706f2 15338-170 HUMAN PRESCRIPTI
NDA NDA080680 Apace Packaging FOLIC ACID 1 mg/1
15338-200_66234596-162c-4a33-b87e-635839655654 15338-200 HUMAN PRESCRIPTI
ON DRUG Enalapril Maleate Enalapril Maleate "TABLET, SOLUBLE
" ORAL 20090822 ANDA ANDA075843 Apace Packaging
ENALAPRIL MALEATE 2.5 mg/1 "Angiotensin Converting Enzyme Inhibitor
PE]"
PE]"
PE]"
PE]"
15338-600_40c97a84-32b2-49cf-8c00-b2485b4e9d5f 15338-600 HUMAN PRESCRIPTI
ON DRUG Belladonna Alkaloids with Phenobartbital Belladonna Alkal
oids with Phenobartbital TABLET ORAL 20001201 UNAPPROV
ED DRUG OTHER Apace Packaging ATROPINE SULFATE; HYOSCYAMINE SULFATE; P
HENOBARBITAL; SCOPOLAMINE HYDROBROMIDE .0194; .1037; 16.2; .0065 mg/1; mg
/1; mg/1; mg/1 "Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic
Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholin
ergic [EPC],Cholinergic Antagonists [MoA]"
15338-100_b3fa8d62-cec4-416b-b979-56a945423ae1 15338-100 HUMAN PRESCRIPTI
ON DRUG Doxycycline Hyclate Doxycycline Hyclate "CAPSULE, GELATI
N COATED" ORAL 19840507 ANDA ANDA062396 Apace Pa
ckaging LLC DOXYCYCLINE HYCLATE 100 mg/1 "Tetracycline-class Drug
[EPC],Tetracyclines [Chemical/Ingredient]"
15338-122_8a9c319f-f300-3f89-5276-116410b86a26 15338-122 HUMAN PRESCRIPTI
ON DRUG Klor-Con M10 Potassium Chloride "TABLET, EXTENDED RELEAS
E" ORAL 20000809 ANDA ANDA074726 Apace Packaging
LLC POTASSIUM CHLORIDE 10 meq/1 "Potassium Compounds [Chemical/I
ngredient],Potassium Salt [EPC]"
15338-133_8a9c319f-f300-3f89-5276-116410b86a26 15338-133 HUMAN PRESCRIPTI
ON DRUG Klor-Con M20 Potassium Chloride "TABLET, EXTENDED RELEAS
E" ORAL 20000809 ANDA ANDA074726 Apace Packaging
LLC POTASSIUM CHLORIDE 20 meq/1 "Potassium Compounds [Chemical/I
57501-865_10d2838b-1bb2-47ef-a726-1ae087ce63c8 57501-865 HUMAN OTC DRUG
Mata Piojos A Pediculicide Low Foaming "Pyrethrum Extract, Piperonyl Bu
toxide" SHAMPOO TOPICAL 20100423 OTC MONOGRAPH FINAL part358G
Apex International Mfg PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 2.4; .12
g/60g; g/60g
57501-953_5533c604-c92e-4002-87ce-c163df9a4cb1 57501-953 HUMAN OTC DRUG
Oil Free Acne Scrub Salicylic Acid Acne Treatment Salicylic Acid LIQUID
TOPICAL 20100708 OTC MONOGRAPH FINAL part333D Apex Int
ernational Mfg SALICYLIC ACID 2.5 g/125g
65465-0001_41764a77-d6d6-44f9-b355-ca3fdaccbf61 65465-0001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS Apex of St. Peters OXYGEN 99 L/100L
57685-7110_02a4201d-2574-4dcd-9208-d56f45b58016 57685-7110 HUMAN OTC DRUG
Instant Hand Sanitizer alcohol GEL TOPICAL 20130327
OTC MONOGRAPH NOT FINAL part333E "APEX Sanitation, LLC" ALCOHOL 540.26
g/L
55259-1001_dca166e2-4401-4348-925a-2f62ae3036bb 55259-1001 HUMAN OTC DRUG
7030 Calcium Gold CALCIUM CAPSULE ORAL 20130310
UNAPPROVED DRUG OTHER "Apexel Co., Ltd" CALCIUM 0.99 1-Jan
55259-2001_0353adbd-40c2-4b98-b475-1be1bf907695 55259-2001 HUMAN OTC DRUG
7030 Calcium Premium CALCIUM CAPSULE ORAL 20130310
UNAPPROVED DRUG OTHER "Apexel Co., Ltd" CALCIUM 0.99 1-Jan
53401-200_a7295887-cfd9-4422-9395-01a77676c9f4 53401-200 HUMAN PRESCRIPTI
ANDA ANDA077289 "Aphena Pharma Solutions - New Jersey, LLC" CITALOPR
53401-300_cc8b4662-82e8-41ef-a112-17c110da6b66 53401-300 HUMAN PRESCRIPTI
ATED" ORAL 19860710 ANDA ANDA062677 "Aphena Pharma S
olutions - New Jersey, LLC" DOXYCYCLINE HYCLATE 100 mg/1
53401-301_9a9adf9b-389b-40f2-980e-38d7c5b15033 53401-301 HUMAN PRESCRIPTI
20090801 ANDA ANDA077859 "Aphena Pharma Solutions - New J
ersey, LLC" CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 "Quinolone Antim
43353-035_722b7796-becb-4bd0-ad66-ef8a4d7ff7b9 43353-035 HUMAN PRESCRIPTI
20091221 ANDA ANDA071995 "Aphena Pharma Solutions - Tenne
ssee, Inc." PRAZOSIN HYDROCHLORIDE 2 mg/1 "Adrenergic alpha-Antago
43353-074_c1cede8c-12ef-4678-be73-35f8b16f2fe3 43353-074 HUMAN PRESCRIPTI
ORAL 20070102 ANDA ANDA072253 "Aphena Pharma Solutions
- Tennessee, Inc." OXAZEPAM 30 mg/1 "Benzodiazepine [EPC],Be
nzodiazepines [Chemical/Ingredient]" CIV
43353-131_0bedfead-19aa-4149-ba58-4d0f189267b7 43353-131 HUMAN PRESCRIPTI
ON DRUG Dilantin Phenytoin Sodium "CAPSULE, EXTENDED RELEA
SE" ORAL 19760827 ANDA ANDA084349 "Aphena Pharma S
olutions - Tennessee, Inc." PHENYTOIN SODIUM 100 mg/1 "Anti-ep
ivity [PE]"
43353-244_d77d1a4a-a796-461e-8f2a-fa85d3349a86 43353-244 HUMAN PRESCRIPTI
"Aphena Pharma Solutions - Tennessee, Inc." FEXOFENADINE HYDROCHLORIDE
tagonist [EPC]"
43353-323_741bda18-742a-4192-b37c-41680ca38343 43353-323 HUMAN PRESCRIPTI
ON DRUG Levitra vardenafil hydrochloride "TABLET, FILM COATED"
ORAL 20080515 NDA NDA021400 "APHENA PHARMA SOLUTIONS
- TENNESSEE, INC." VARDENAFIL HYDROCHLORIDE 5 mg/1 "Phospho
diesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]"
43353-324_175e43e8-c69d-4ddf-9ae9-ef51dba79a01 43353-324 HUMAN PRESCRIPTI
ON DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITA
RTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA
ANDA040409 "Aphena Pharma Solutions - Tennessee, Inc." ACETAMINOPHEN; H
nists [MoA]" CIII
43353-336_02f805df-1cef-426c-956d-d038b5ff2ff8 43353-336 HUMAN PRESCRIPTI
NDA NDA021402 "Aphena Pharma Solutions - Tennessee, Inc." LEVOTHYR
OXINE SODIUM 137 ug/1 "l-Thyroxine [EPC],Thyroxine [Chemical/Ingredien
t]"
43353-389_d0243c04-2828-4d38-b95e-b23374e52d27 43353-389 HUMAN PRESCRIPTI
ANDA ANDA078558 "Aphena Pharma Solutions - Tennessee, Inc." IBUPROFE
]"
]"
]"
YDROCODONE BITARTRATE 750; 7.5 mg/1; mg/1 "Opioid Agonist [EPC],Op
43353-474_c73f3c0c-77c4-4ac3-a233-f987068b94ac 43353-474 HUMAN PRESCRIPTI
ON DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL
ssee, Inc." PRAVASTATIN SODIUM 40 mg/1 "HMG-CoA Reductase Inhib
43353-491_6e052f18-f7a6-4e8b-9222-0a12572960b6 43353-491 HUMAN PRESCRIPTI
ON DRUG COUMADIN warfarin sodium TABLET ORAL 20090101
NDA NDA009218 "Aphena Pharma Solutions - Tennessee, Inc." WARFARIN
SODIUM 10 mg/1 "Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA]"
SODIUM 7.5 mg/1 "Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA]"
43353-510_0b579053-078d-424a-ba43-56db5dcb90aa 43353-510 HUMAN PRESCRIPTI
ssee, Inc." CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 "Aromatic Amino
Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA]"
43353-633_e3436ec4-da38-4e59-a2cf-e573bb00925a 43353-633 HUMAN PRESCRIPTI
ON DRUG Rocaltrol calcitriol "CAPSULE, GELATIN COATED"
ORAL 20090810 NDA NDA018044 "Aphena Pharma Solutions
- Tennessee, Inc." CALCITRIOL 0.25 ug/1 "Cholecalciferol [Chemic
al/Ingredient],Vitamin D3 Analog [EPC]"
43353-637_07597a7f-cb77-473d-8d64-44f8b0154b71 43353-637 HUMAN PRESCRIPTI
ON DRUG Fluoxetine Hydrochloride Fluoxetine Hydrochloride
CAPSULE ORAL 20010802 ANDA ANDA075049 "Aphena Pharma S
olutions - Tennessee, Inc." FLUOXETINE HYDROCHLORIDE 10 mg/1
"Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]"
43353-657_d23b71f4-876d-4774-8b8c-3eb0303b2dbd 43353-657 HUMAN PRESCRIPTI
ON DRUG PredniSONE PredniSONE TABLET ORAL 19720421
ANDA ANDA080352 "Aphena Pharma Solutions - Tennessee, Inc." PREDNISO
NE 5 mg/1
43353-687_950b1a7a-07f6-4741-9846-0e2f7e798e3e 43353-687 HUMAN PRESCRIPTI
ON DRUG Premarin conjugated estrogens "TABLET, FILM COATED"
- Tennessee, Inc." "ESTROGENS, CONJUGATED" 0.3 mg/1 "Estrogen [EPC],
Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredien
t]"
43353-688_950b1a7a-07f6-4741-9846-0e2f7e798e3e 43353-688 HUMAN PRESCRIPTI
ON DRUG Premarin conjugated estrogens "TABLET, FILM COATED"
- Tennessee, Inc." "ESTROGENS, CONJUGATED" 0.625 mg/1 "Estrogen [EPC],
Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredien
t]"
43353-709_63578037-37d7-4aff-8c75-da3338940c06 43353-709 HUMAN PRESCRIPTI
ANDA ANDA090705 "Aphena Pharma Solutions - Tennessee, Inc." GABAPENT
43353-735_0f90e61a-246f-4162-929d-001bec7e31d4 43353-735 HUMAN PRESCRIPTI
"Aphena Pharma Solutions - Tennessee, Inc." BUPROPION HYDROCHLORIDE 100
mg/1 "Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine A
ctivity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibi
tors [MoA]"
43353-736_c2c53be9-ea0f-4dc5-a61f-2b6f8904d842 43353-736 HUMAN PRESCRIPTI
RELEASE" ORAL 20110120 ANDA ANDA078281 "Aphena
Pharma Solutions - Tennessee, Inc." PANTOPRAZOLE SODIUM 40 mg/1
"Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]"
43353-741_95bf61f7-6238-4b01-b70e-df731b5f642b 43353-741 HUMAN PRESCRIPTI
43353-768_32c9ba10-d55e-4ed1-9ae8-6621580495df 43353-768 HUMAN PRESCRIPTI
ON DRUG Simvastatin Simvastatin "TABLET, FILM COATED" ORAL
ssee, Inc." SIMVASTATIN 80 mg/1 "HMG-CoA Reductase Inhibitor [EP
C],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"
43353-769_36b19b28-8577-4be5-bab3-b8f32b9f6a33 43353-769 HUMAN PRESCRIPTI
ON DRUG Oxybutynin Chloride Oxybutynin Chloride "TABLET, FILM CO
"Aphena Pharma Solutions - Tennessee, Inc." OXYBUTYNIN CHLORIDE 10
mg/1 "Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagoni
sts [MoA]"
43353-771_c132877c-8560-4c40-aa6a-d53da089ff5a 43353-771 HUMAN PRESCRIPTI
ON DRUG SALSALATE SALSALATE TABLET ORAL 20110522
UNAPPROVED DRUG OTHER "Aphena Pharma Solutions - Tennessee, Inc."
SALSALATE 750 mg/1
43353-772_23a800db-9bfe-464f-9fc2-5090f2fa6840 43353-772 HUMAN PRESCRIPTI
ssee, Inc." GEMFIBROZIL 600 mg/1 "Peroxisome Proliferator Recepto
r alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists
[MoA],PPAR alpha [Chemical/Ingredient]"
43353-773_32c9ba10-d55e-4ed1-9ae8-6621580495df 43353-773 HUMAN PRESCRIPTI
ssee, Inc." SIMVASTATIN 20 mg/1 "HMG-CoA Reductase Inhibitor [EP
43353-784_fd5924d8-e3f8-4164-81d6-2a5aea0dd202 43353-784 HUMAN PRESCRIPTI
Pharma Solutions - Tennessee, Inc." DICLOFENAC SODIUM 50 mg/1
"Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonster
matory Drug [EPC]"
43353-787_01211049-3b2e-4d9c-a26b-ff2b30bcb118 43353-787 HUMAN PRESCRIPTI
ON DRUG Sertraline Hydrochloride sertraline "TABLET, FILM CO
olutions - Tennessee, Inc." SERTRALINE HYDROCHLORIDE 100 mg/1
67544-023_5d9e47c2-cf3a-4def-a906-1d7fe00c6620 67544-023 HUMAN PRESCRIPTI
nists [MoA]" CIII
nists [MoA]" CIII
nists [MoA]" CIII
67544-052_bc534aeb-3ada-4dc5-8d65-d7b321f4b500 67544-052 HUMAN PRESCRIPTI
67544-057_31c3f6b2-2ac4-440f-90bc-15aae152d990 67544-057 HUMAN PRESCRIPTI
ON DRUG Phenobarbital phenobarbital TABLET ORAL 20030201
UNAPPROVED DRUG OTHER "Aphena Pharma Solutions - Tennessee, Inc."
PHENOBARBITAL 32.4 mg/1 CIV
67544-061_81f2d4c7-c121-42a1-81a2-902b8eda11cf 67544-061 HUMAN PRESCRIPTI
t]"
67544-189_d6e1473b-b1ff-4562-b1ab-65e820de2692 67544-189 HUMAN PRESCRIPTI
ON DRUG Effexor XR Extended-Release venlafaxine hydrochloride "CAPSULE
"Aphena Pharma Solutions - Tennessee, Inc." VENLAFAXINE HYDROCHLORIDE
150 mg/1 "Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepineph
rine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]"
67544-306_1e4cd5c0-6b72-4fae-a4c7-95f8ef34cc87 67544-306 HUMAN PRESCRIPTI
ON DRUG Fosinopril Sodium Fosinopril Sodium TABLET ORAL
ssee, Inc." FOSINOPRIL SODIUM 40 mg/1 "Angiotensin Converting
Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]"
67544-322_1e4cd5c0-6b72-4fae-a4c7-95f8ef34cc87 67544-322 HUMAN PRESCRIPTI
ssee, Inc." FOSINOPRIL SODIUM 20 mg/1 "Angiotensin Converting
67544-349_feae1673-5b26-40a2-9127-24426383a86b 67544-349 HUMAN PRESCRIPTI
ON DRUG Klor-Con M Potassium Chloride "TABLET, EXTENDED RELEAS
E" ORAL 20110118 ANDA ANDA074726 "Aphena Pharma S
olutions - Tennessee, Inc." POTASSIUM CHLORIDE 1500 mg/1 "Potassi
67544-371_64ebbee6-7e2a-455f-9f96-92bc25d3e691 67544-371 HUMAN PRESCRIPTI
ANDA ANDA075798 "Aphena Pharma Solutions - Tennessee, Inc." ALLOPURI
NOL 300 mg/1 "Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhib
itors [MoA]"
67544-507_2f463f71-cfb1-4db3-a004-02b88ceae1ad 67544-507 HUMAN PRESCRIPTI
67544-511_4cb7dc91-6c9a-4feb-b2aa-7b4724e9f681 67544-511 HUMAN PRESCRIPTI
Hydrochloride TABLET ORAL 20050628 ANDA ANDA076716
"Aphena Pharma Solutions - Tennessee, Inc." GLYBURIDE; METFORMIN HYDROCHLORI
67544-512_2f463f71-cfb1-4db3-a004-02b88ceae1ad 67544-512 HUMAN PRESCRIPTI
67544-534_4638c35e-72ef-4f22-832c-de21700093dc 67544-534 HUMAN PRESCRIPTI
ON DRUG Lithium Carbonate Lithium Carbonate "CAPSULE, GELATI
N COATED" ORAL 19801126 NDA NDA017812 "Aphena
Pharma Solutions - Tennessee, Inc." LITHIUM CARBONATE 300 mg/1
Mood Stabilizer [EPC]
67544-662_12218dbe-1891-4491-b98c-caf6750ae792 67544-662 HUMAN PRESCRIPTI
ANDA ANDA085159 "Aphena Pharma Solutions - Tennessee, Inc." METHOCAR
BAMOL 750 mg/1 "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxa
nt [EPC]"
nists [MoA]" CIII
67544-725_7db1e55e-aa96-49a3-b21e-62e198e1877a 67544-725 HUMAN PRESCRIPTI
ON DRUG Triazolam Triazolam TABLET ORAL 19940601
ANDA ANDA074224 "Aphena Pharma Solutions - Tennessee, Inc." TRIAZOLA
M 0.25 mg/1 "Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredie
nt]" CIV
67544-747_12218dbe-1891-4491-b98c-caf6750ae792 67544-747 HUMAN PRESCRIPTI
ANDA ANDA085159 "Aphena Pharma Solutions - Tennessee, Inc." METHOCAR
nt [EPC]"
67544-840_f4f39613-d1df-48ec-9b69-2ec30b4a5dc4 67544-840 HUMAN PRESCRIPTI
matory Drug [EPC]"
t]"
t]"
t]"
t]"
t]"
t]"
t]"
t]"
t]"
67544-899_f4f39613-d1df-48ec-9b69-2ec30b4a5dc4 67544-899 HUMAN PRESCRIPTI
matory Drug [EPC]"
67544-946_4638c35e-72ef-4f22-832c-de21700093dc 67544-946 HUMAN PRESCRIPTI
ON DRUG Lithium Carbonate Lithium Carbonate "CAPSULE, GELATI
N COATED" ORAL 19870128 NDA NDA017812 "Aphena
Pharma Solutions - Tennessee, Inc." LITHIUM CARBONATE 150 mg/1
Mood Stabilizer [EPC]
67544-988_64ebbee6-7e2a-455f-9f96-92bc25d3e691 67544-988 HUMAN PRESCRIPTI
ANDA ANDA075798 "Aphena Pharma Solutions - Tennessee, Inc." ALLOPURI
NOL 100 mg/1 "Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhib
itors [MoA]"
43353-031_0291bd29-faa4-4aa9-83f6-7cb28c229413 43353-031 HUMAN PRESCRIPTI
ON DRUG CRESTOR Rosuvastatin calcium "TABLET, FILM COATED" ORAL
20030818 NDA NDA021366 "Aphena Pharma Solutions - Tenne
ssee, LLC" ROSUVASTATIN CALCIUM 40 mg/1 "HMG-CoA Reductase Inhib
43353-032_159645df-cd6b-46a3-842b-2d50c920a8de 43353-032 HUMAN PRESCRIPTI
NDA NDA021656 "Aphena Pharma Solutions - Tennessee, LLC" FENOFIBR
ATE 145 mg/1 "Peroxisome Proliferator Receptor alpha Agonist [EPC],Pe
roxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemic
al/Ingredient]"
43353-034_6919ba25-ae85-4fdc-b8d7-48ce9b26e3d5 43353-034 HUMAN PRESCRIPTI
ON DRUG Calcitriol Calcitriol CAPSULE ORAL 20060327
ANDA ANDA076917 "Aphena Pharma Solutions - Tennessee, LLC" CALCITRI
OL 0.25 ug/1 "Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog
[EPC]"
43353-049_b2821ecc-6d75-4ea4-b57c-78ad508fe7e3 43353-049 HUMAN PRESCRIPTI
ANDA ANDA040301 "Aphena Pharma Solutions - Tennessee, LLC" WARFARIN
43353-061_e8c9f182-fcbd-49b2-bd85-7a5ff1060ac1 43353-061 HUMAN PRESCRIPTI
NDA NDA018333 "Aphena Pharma Solutions - Tennessee, LLC" SUCRALFA
TE 1 g/1 "Aluminum Complex [EPC],Organometallic Compounds [Chemic
al/Ingredient]"
43353-072_5e1836c1-7b36-4ea5-8fa2-87e8d8d6b21f 43353-072 HUMAN PRESCRIPTI
- Tennessee, LLC" TRAMADOL HYDROCHLORIDE 50 mg/1 "Full Opioid Ago
nists [MoA],Opioid Agonist [EPC]" CIV
43353-090_885cf4de-06f5-4acc-8feb-f61e7642b366 43353-090 HUMAN PRESCRIPTI
ssee, LLC" GEMFIBROZIL 600 mg/1 "Peroxisome Proliferator Recepto
r alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists
[MoA],PPAR alpha [Chemical/Ingredient]"
43353-132_8b8d0afd-873e-40cd-95e6-336eb2a4ca45 43353-132 HUMAN PRESCRIPTI
ON DRUG Carvedilol carvedilol "TABLET, FILM COATED" ORAL
ssee, LLC" CARVEDILOL 3.125 mg/1 "Adrenergic alpha-Antagonists [M
oA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-
Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC]"
ssee, LLC" CARVEDILOL 25 mg/1 "Adrenergic alpha-Antagonists [M
43353-149_800910de-96de-4c4c-8028-221b98c7d164 43353-149 HUMAN PRESCRIPTI
ON DRUG Atenolol and Chlorthalidone Atenolol and Chlorthalidone
TABLET ORAL 19920801 ANDA ANDA073665 "Aphena Pharma S
olutions - Tennessee, LLC" ATENOLOL; CHLORTHALIDONE 50; 25 mg/1; mg
/1 "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increas
ed Diuresis [PE],Thiazide-like Diuretic [EPC]"
43353-159_d22cfbf2-c9ef-43fc-b930-6716f9cc45eb 43353-159 HUMAN PRESCRIPTI
ANDA040355 "Aphena Pharma Solutions - Tennessee, LLC" ACETAMINOPHEN; H
nists [MoA]" CIII
43353-178_b0d8a6ff-5163-4f29-abcd-8318b92bbef9 43353-178 HUMAN PRESCRIPTI
ON DRUG Prograf Tacrolimus "CAPSULE, GELATIN COATED" ORAL
ssee, LLC" TACROLIMUS 1 mg/1 "Calcineurin Inhibitor Immunosup
pressant [EPC],Calcineurin Inhibitors [MoA]"
43353-199_42a6af57-84a5-44dd-a4a0-ec9d5e954a62 43353-199 HUMAN PRESCRIPTI
ON DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL
ssee, LLC" HYDROXYZINE PAMOATE 25 mg/1 "Antihistamine [EPC],His
tamine Receptor Antagonists [MoA]"
43353-215_781c4c71-059d-40d0-bcd3-0867dcb550f3 43353-215 HUMAN PRESCRIPTI
D RELEASE" ORAL 20040818 ANDA ANDA076368 "Aphena
Pharma Solutions - Tennessee, LLC" POTASSIUM CHLORIDE 20 meq/1
43353-263_219f8e97-5db0-4cb5-b5cf-74c64142047e 43353-263 HUMAN PRESCRIPTI
ON DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230
NDA NDA021446 "Aphena Pharma Solutions - Tennessee, LLC" PREGABAL
IN 50 mg/1 CV
IN 75 mg/1 CV
43353-277_12b95e60-10f9-423f-9838-b2f514637f39 43353-277 HUMAN PRESCRIPTI
ANDA ANDA077856 "Aphena Pharma Solutions - Tennessee, LLC" CLONAZEP
AM 1 mg/1 "Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredie
nt]" CIV
43353-303_061f7a95-4302-49fa-8ecf-9f9a55ef0f31 43353-303 HUMAN PRESCRIPTI
ON DRUG Cymbalta Duloxetine hydrochloride "CAPSULE, DELAYE
D RELEASE" ORAL 20040824 NDA NDA021427 "Aphena
Pharma Solutions - Tennessee, LLC" DULOXETINE HYDROCHLORIDE 30
43353-310_ca87b71c-a13f-4675-b686-e8af41f108b4 43353-310 HUMAN PRESCRIPTI
E" ORAL 20000804 NDA NDA021168 "Aphena Pharma S
olutions - Tennessee, LLC" DIVALPROEX SODIUM 500 mg/1 "Anti-ep
43353-338_d210a49a-4415-4bb1-b333-8027e459711b 43353-338 HUMAN PRESCRIPTI
ON DRUG Pantoprazole Sodium Delayed-Release pantoprazole sodium "TABLET,
DELAYED RELEASE" ORAL 20080131 NDA NDA020987
"Aphena Pharma Solutions - Tennessee, LLC" PANTOPRAZOLE SODIUM 40
mg/1 "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]"
43353-340_f51ea50d-671d-4901-b5c0-e6135df7e54e 43353-340 HUMAN PRESCRIPTI
ON DRUG Metformin Hydrochloride Metformin Hydrochloride "TABLET, FILM CO
olutions - Tennessee, LLC" METFORMIN HYDROCHLORIDE 500 mg/1 "Biguani
de [EPC],Biguanides [Chemical/Ingredient]"
43353-367_e666a290-143d-4b82-8f54-841db9acabe4 43353-367 HUMAN PRESCRIPTI
ssee, LLC" OXYBUTYNIN CHLORIDE 5 mg/1 "Cholinergic Muscarinic
43353-368_1242512b-c6e2-466f-a829-aed0a76785da 43353-368 HUMAN PRESCRIPTI
"Aphena Pharma Solutions - Tennessee, LLC" SULFAMETHOXAZOLE; TRIMETHOPRIM
800; 160 mg/1; mg/1 "Sulfonamide Antimicrobial [EPC],Sulfonamides [C
hemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase
Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochro
me P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]"
IN 100 mg/1 CV
IN 150 mg/1 CV
43353-436_048d999c-3507-43e8-ac09-b9013ac06e38 43353-436 HUMAN PRESCRIPTI
ON DRUG Methocarbamol methocarbamol TABLET ORAL 20030129
ANDA ANDA040489 "Aphena Pharma Solutions - Tennessee, LLC" METHOCAR
nt [EPC]"
43353-495_f3aa98c4-1227-4097-9c56-b672796d749d 43353-495 HUMAN PRESCRIPTI
ON DRUG Sulfasalazine Sulfasalazine TABLET ORAL 20030701
NDA AUTHORIZED GENERIC NDA007073 "Aphena Pharma Solutions - Tennessee, LL
C" SULFASALAZINE 500 mg/1 "Aminosalicylate [EPC],Aminosalicylic Ac
ids [Chemical/Ingredient]"
43353-506_8bdbc4d3-bc72-4981-8cc8-92d9b6a0b523 43353-506 HUMAN PRESCRIPTI
ANDA ANDA075927 "Aphena Pharma Solutions - Tennessee, LLC" NAPROXEN
250 mg/1 "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory
43353-535_a8065d90-4130-414c-8b4b-17d5855067b8 43353-535 HUMAN PRESCRIPTI
ssee, LLC" MIRTAZAPINE 15 mg/1
43353-538_83ef2126-1308-4f4c-a917-a360c7e9f3f1 43353-538 HUMAN PRESCRIPTI
ON DRUG BuPROPion Hydrochloride BuPROPion Hydrochloride "TABLET, FILM CO
"Aphena Pharma Solutions - Tennessee, LLC" BUPROPION HYDROCHLORIDE 100
tors [MoA]"
43353-544_8065ca49-06d7-4373-81d0-17e4c33a30b5 43353-544 HUMAN PRESCRIPTI
ON DRUG Paroxetine paroxetine hydrochloride hemihydrate "TABLET,
FILM COATED" ORAL 20080324 ANDA ANDA078902 "Aphena
Pharma Solutions - Tennessee, LLC" PAROXETINE HYDROCHLORIDE HEMIHYDRATE
[MoA]"
43353-546_83ef2126-1308-4f4c-a917-a360c7e9f3f1 43353-546 HUMAN PRESCRIPTI
tors [MoA]"
43353-547_a83f0491-37ca-4f44-bb12-2c6780831484 43353-547 HUMAN PRESCRIPTI
ON DRUG Divalproex Sodium divalproex sodium "TABLET, FILM CO
"Aphena Pharma Solutions - Tennessee, LLC" DIVALPROEX SODIUM 500
43353-554_8065ca49-06d7-4373-81d0-17e4c33a30b5 43353-554 HUMAN PRESCRIPTI
ON DRUG Paroxetine paroxetine hydrochloride hemihydrate "TABLET,
FILM COATED" ORAL 20080324 ANDA ANDA078902 "Aphena
Pharma Solutions - Tennessee, LLC" PAROXETINE HYDROCHLORIDE HEMIHYDRATE
[MoA]"
43353-583_f3ee686a-e28c-4af6-b06d-e90642ab6442 43353-583 HUMAN PRESCRIPTI
ON DRUG Metoprolol Succinate Metoprolol Succinate "TABLET, FILM CO
"Aphena Pharma Solutions - Tennessee, LLC" METOPROLOL SUCCINATE 50
43353-599_c88a9891-341c-436c-a5dc-60cfe656d1ba 43353-599 HUMAN PRESCRIPTI
ON DRUG Verapamil Hydrochloride verapamil hydrochloride "TABLET, FILM CO
"Aphena Pharma Solutions - Tennessee, LLC" VERAPAMIL HYDROCHLORIDE 180
43353-600_c88a9891-341c-436c-a5dc-60cfe656d1ba 43353-600 HUMAN PRESCRIPTI
ON DRUG Verapamil Hydrochloride verapamil hydrochloride "TABLET, FILM CO
"Aphena Pharma Solutions - Tennessee, LLC" VERAPAMIL HYDROCHLORIDE 240
43353-607_eb043003-31d8-4757-ac93-1bb8960cf7a4 43353-607 HUMAN PRESCRIPTI
ON DRUG Buspirone Hydrochloride buspirone hydrochloride TABLET ORAL
ssee, LLC" BUSPIRONE HYDROCHLORIDE 15 mg/1
43353-617_e3b4f606-6863-49a5-be7c-48d86b85bdaf 43353-617 HUMAN PRESCRIPTI
ON DRUG Zolpidem Tartrate zolpidem tartrate "TABLET, FILM CO
olutions - Tennessee, LLC" ZOLPIDEM TARTRATE 10 mg/1 "gamma-A
43353-620_e3b4f606-6863-49a5-be7c-48d86b85bdaf 43353-620 HUMAN PRESCRIPTI
olutions - Tennessee, LLC" ZOLPIDEM TARTRATE 5 mg/1 "gamma-A
43353-635_6843ed60-a1a4-4a20-a079-8cc1ee7af7ce 43353-635 HUMAN PRESCRIPTI
ON DRUG Hydrochlorothiazide hydrochlorothiazide "CAPSULE, GELATI
N COATED" ORAL 20020917 ANDA ANDA075907 "Aphena
Pharma Solutions - Tennessee, LLC" HYDROCHLOROTHIAZIDE 12.5 mg/1
"Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient]
"
43353-643_25ac0c57-97da-401c-b475-0bd41cc83673 43353-643 HUMAN PRESCRIPTI
ANDA ANDA075743 "Aphena Pharma Solutions - Tennessee, LLC" LISINOPR
IL 2.5 mg/1 "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotens
43353-647_094bc311-4e4d-4a6e-9f7b-6015e38af182 43353-647 HUMAN PRESCRIPTI
ANDA ANDA075509 "Aphena Pharma Solutions - Tennessee, LLC" DOXAZOSI
N MESYLATE 2 mg/1 "Adrenergic alpha-Antagonists [MoA],alpha-Adrene
rgic Blocker [EPC]"
43353-648_094bc311-4e4d-4a6e-9f7b-6015e38af182 43353-648 HUMAN PRESCRIPTI
rgic Blocker [EPC]"
43353-652_79266f41-f728-4daa-9c57-b2a5f3881e17 43353-652 HUMAN PRESCRIPTI
olutions - Tennessee, LLC" TRAZODONE HYDROCHLORIDE 50 mg/1 Serotoni
n Reuptake Inhibitor [EPC]
43353-653_79266f41-f728-4daa-9c57-b2a5f3881e17 43353-653 HUMAN PRESCRIPTI
olutions - Tennessee, LLC" TRAZODONE HYDROCHLORIDE 100 mg/1 Serotoni
n Reuptake Inhibitor [EPC]
43353-656_2a0c2fc7-a26a-4b44-9383-d702cb159a21 43353-656 HUMAN PRESCRIPTI
ON DRUG Glyburide glyburide TABLET ORAL 19840501
C" GLYBURIDE 5 mg/1 "Sulfonylurea [EPC],Sulfonylurea Compoun
ds [Chemical/Ingredient]"
C" GLYBURIDE 2.5 mg/1 "Sulfonylurea [EPC],Sulfonylurea Compoun
43353-662_25ac0c57-97da-401c-b475-0bd41cc83673 43353-662 HUMAN PRESCRIPTI
ANDA ANDA075743 "Aphena Pharma Solutions - Tennessee, LLC" LISINOPR
IL 40 mg/1 "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotens
43353-663_f6a44bf9-c610-4be8-a289-2bbbe103b9c8 43353-663 HUMAN PRESCRIPTI
ON DRUG Tamsulosin hydrochloride Tamsulosin hydrochloride
olutions - Tennessee, LLC" TAMSULOSIN HYDROCHLORIDE 0.4 mg/1
"Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]"
IN 200 mg/1 CV
43353-677_8bdbc4d3-bc72-4981-8cc8-92d9b6a0b523 43353-677 HUMAN PRESCRIPTI
43353-681_8e145279-0997-4800-901d-6f96059c681c 43353-681 HUMAN PRESCRIPTI
ANDA ANDA040756 "Aphena Pharma Solutions - Tennessee, LLC" FOLIC AC
ID 1 mg/1
43353-684_b5d4081c-5d64-4deb-abb8-955faa99f251 43353-684 HUMAN PRESCRIPTI
ON DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL
ssee, LLC" AMLODIPINE BESYLATE 5 mg/1 "Calcium Channel Antagon
ists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemi
cal/Ingredient]"
43353-686_2b1eb024-67ec-47d5-a360-b2194ce79f33 43353-686 HUMAN PRESCRIPTI
ANDA ANDA074069 "Aphena Pharma Solutions - Tennessee, LLC" AZATHIOP
RINE 50 mg/1 "Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Anal
og [Chemical/Ingredient],Purine Antimetabolite [EPC],Purines [Chemical/Ingredien
t]"
43353-689_a9d8d871-3b80-47a6-9029-1e9445bcdf77 43353-689 HUMAN PRESCRIPTI
olutions - Tennessee, LLC" VENLAFAXINE HYDROCHLORIDE 37.5 mg/1
"Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake In
hibitor [EPC],Serotonin Uptake Inhibitors [MoA]"
43353-690_a9d8d871-3b80-47a6-9029-1e9445bcdf77 43353-690 HUMAN PRESCRIPTI
olutions - Tennessee, LLC" VENLAFAXINE HYDROCHLORIDE 75 mg/1
43353-691_b5d4081c-5d64-4deb-abb8-955faa99f251 43353-691 HUMAN PRESCRIPTI
ON DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL
ssee, LLC" AMLODIPINE BESYLATE 10 mg/1 "Calcium Channel Antagon
ists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemi
cal/Ingredient]"
43353-693_ddc19c82-dad2-4b79-abda-4730858afea8 43353-693 HUMAN PRESCRIPTI
ON DRUG Azithromycin Azithromycin "TABLET, FILM COATED" ORAL
ssee, LLC" AZITHROMYCIN MONOHYDRATE 250 mg/1 "Macrolide Antim
icrobial [EPC],Macrolides [Chemical/Ingredient]"
43353-701_018fea8f-a408-468e-b2c5-c203cd8ef235 43353-701 HUMAN PRESCRIPTI
ON DRUG Propranolol Hydrochloride propranolol hydrochloride
olutions - Tennessee, LLC" PROPRANOLOL HYDROCHLORIDE 20 mg/1
43353-706_018fea8f-a408-468e-b2c5-c203cd8ef235 43353-706 HUMAN PRESCRIPTI
olutions - Tennessee, LLC" PROPRANOLOL HYDROCHLORIDE 40 mg/1
43353-711_7d55fc67-1183-48fe-b6f6-a9cbc1df0d25 43353-711 HUMAN PRESCRIPTI
ON DRUG Temazepam temazepam CAPSULE ORAL 20121025
ANDA ANDA070920 "Aphena Pharma Solutions - Tennessee, LLC" TEMAZEPA
nt]" CIV
43353-724_6ff594b7-180e-4f63-a0e4-aa9e41205051 43353-724 HUMAN PRESCRIPTI
ON DRUG LANOXIN digoxin TABLET ORAL 19840702 20150930
NDA NDA020405 "Aphena Pharma Solutions - Tennessee, LLC" DIGOXIN
250 ug/1 "Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient
]"
43353-725_6ff594b7-180e-4f63-a0e4-aa9e41205051 43353-725 HUMAN PRESCRIPTI
ON DRUG LANOXIN digoxin TABLET ORAL 19840914 20150930
NDA NDA020405 "Aphena Pharma Solutions - Tennessee, LLC" DIGOXIN
125 ug/1 "Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient
]"
43353-727_8f487e7b-4fbe-4c56-b86f-4cfcda789e09 43353-727 HUMAN PRESCRIPTI
NDA021774 "Aphena Pharma Solutions - Tennessee, LLC" ZOLPIDEM TARTRAT
E 12.5 mg/1 "gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agon
ists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE
]" CIV
43353-732_d8e9d4e0-1fe8-45df-96ac-b6328eb3301d 43353-732 HUMAN PRESCRIPTI
ssee, LLC" HYDROCHLOROTHIAZIDE 25 mg/1 "Increased Diuresis [PE]
43353-733_d8e9d4e0-1fe8-45df-96ac-b6328eb3301d 43353-733 HUMAN PRESCRIPTI
nists [MoA]" CIII
43353-737_3f914177-d57c-4f45-9cf3-4b98f8354ef8 43353-737 HUMAN PRESCRIPTI
NDA NDA018569 "Aphena Pharma Solutions - Tennessee, LLC" FUROSEMI
[EPC]"
43353-742_959e4ed8-d633-4f2c-a52d-775c3ef577df 43353-742 HUMAN PRESCRIPTI
"Aphena Pharma Solutions - Tennessee, LLC" HYDRALAZINE HYDROCHLORIDE
50 mg/1 "Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]"
43353-747_2656c2f1-2696-4c6a-9f2f-8e738b86cceb 43353-747 HUMAN PRESCRIPTI
[EPC]"
43353-749_3402aba2-a410-42e5-8981-b25e27c07a49 43353-749 HUMAN PRESCRIPTI
ssee, LLC" ETODOLAC 500 mg/1 "Cyclooxygenase Inhibitors [MoA]
,Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Ant
i-inflammatory Drug [EPC]"
43353-750_5d4b75d6-4cf4-461f-9d36-2d6eab6cccc1 43353-750 HUMAN PRESCRIPTI
ELEASE" ORAL 20120723 ANDA ANDA201071 "Aphena Pharma S
olutions - Tennessee, LLC" NIFEDIPINE 90 mg/1 "Calcium Channel
Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridine
ssee, LLC" ETODOLAC 400 mg/1 "Cyclooxygenase Inhibitors [MoA]
ON DRUG Etodolac Etodolac CAPSULE ORAL 19980405
ANDA ANDA075078 "Aphena Pharma Solutions - Tennessee, LLC" ETODOLAC
43353-754_9139290e-82d1-40ea-afbe-4fd7be934799 43353-754 HUMAN PRESCRIPTI
ON DRUG Risperidone risperidone "TABLET, FILM COATED" ORAL
ssee, LLC" RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC]
43353-763_74ee4693-b945-4dda-9ce5-ea72e4568f34 43353-763 HUMAN PRESCRIPTI
ANDA ANDA075991 "Aphena Pharma Solutions - Tennessee, LLC" LOVASTAT
IN 40 mg/1 "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl
-CoA Reductase Inhibitors [MoA]"
43353-764_ef12ceed-7534-472e-a8a8-08cafeada087 43353-764 HUMAN PRESCRIPTI
ON DRUG Viagra sildenafil citrate "TABLET, FILM COATED" ORAL
ssee, LLC" SILDENAFIL CITRATE 25 mg/1 "Phosphodiesterase 5 Inh
43353-767_935e87ee-39e2-46b7-94c1-9d3b88057ff7 43353-767 HUMAN PRESCRIPTI
olutions - Tennessee, LLC" BUPROPION HYDROCHLORIDE 100 mg/1 "Aminoke
43353-779_048d999c-3507-43e8-ac09-b9013ac06e38 43353-779 HUMAN PRESCRIPTI
ON DRUG Methocarbamol methocarbamol TABLET ORAL 20030129
ANDA ANDA040489 "Aphena Pharma Solutions - Tennessee, LLC" METHOCAR
nt [EPC]"
43353-782_5ef126e4-1e7f-4526-8052-148d3ff10a56 43353-782 HUMAN PRESCRIPTI
ON DRUG Afeditab CR Nifedipine "TABLET, FILM COATED, EXTENDED R
43353-783_32c4f44c-dd59-4b03-b271-6e51d20dbf75 43353-783 HUMAN PRESCRIPTI
ANDA ANDA077749 "Aphena Pharma Solutions - Tennessee, LLC" DIAZEPAM
5 mg/1 "Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]"
CIV
43353-785_f8e096c7-a9df-4f0a-8b74-a8d85c8b257a 43353-785 HUMAN PRESCRIPTI
ON DRUG quetiapine fumarate quetiapine fumarate "TABLET, FILM CO
olutions - Tennessee, LLC" QUETIAPINE FUMARATE 100 mg/1 Atypical
Antipsychotic [EPC]
Antipsychotic [EPC]
Antipsychotic [EPC]
43353-790_7c37fbd5-1883-41e4-ac9b-cc4b5ca3efd0 43353-790 HUMAN PRESCRIPTI
ELEASE" ORAL 19800609 NDA NDA018279 "Aphena Pharma S
olutions - Tennessee, LLC" POTASSIUM CHLORIDE 750 mg/1 "Potassi
43353-792_5ef126e4-1e7f-4526-8052-148d3ff10a56 43353-792 HUMAN PRESCRIPTI
ON DRUG Afeditab CR Nifedipine "TABLET, FILM COATED, EXTENDED R
43353-794_fa4f2400-1f0e-402b-a511-b791ad6ab78e 43353-794 HUMAN PRESCRIPTI
olutions - Tennessee, LLC" HYDROXYCHLOROQUINE SULFATE 200 mg/1
43353-795_f3ee686a-e28c-4af6-b06d-e90642ab6442 43353-795 HUMAN PRESCRIPTI
ON DRUG Metoprolol Succinate Metoprolol Succinate "TABLET, FILM CO
"Aphena Pharma Solutions - Tennessee, LLC" METOPROLOL SUCCINATE 100
43353-796_f64c95f3-04d8-4fae-98eb-7c794c449480 43353-796 HUMAN PRESCRIPTI
ON DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL
ssee, LLC" BENZTROPINE MESYLATE 1 mg/1 "Anticholinergic [EPC],A
ntihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists
[MoA]"
43353-797_37a31bbb-6d44-4d2b-a8ed-32dc6f20a3e2 43353-797 HUMAN PRESCRIPTI
ON DRUG Klor-Con M Potassium Chloride "TABLET, EXTENDED RELEAS
E" ORAL 20110118 ANDA ANDA074726 "Aphena Pharma S
olutions - Tennessee, LLC" POTASSIUM CHLORIDE 750 mg/1 "Potassi
43353-798_5050be4b-d47d-4725-9199-caefcc088f11 43353-798 HUMAN PRESCRIPTI
olutions - Tennessee, LLC" VENLAFAXINE HYDROCHLORIDE 75 mg/1
43353-799_12b95e60-10f9-423f-9838-b2f514637f39 43353-799 HUMAN PRESCRIPTI
nt]" CIV
43353-800_3e3953cf-b2ac-42a5-a8a4-e33e0e4f29ad 43353-800 HUMAN PRESCRIPTI
ON DRUG Lisinopril with Hydrochlorothiazide Lisinopril and Hydrochlo
rothiazide TABLET ORAL 20020708 ANDA ANDA076265
"Aphena Pharma Solutions - Tennessee, LLC" HYDROCHLOROTHIAZIDE; LISINOPRIL
25; 20 mg/1; mg/1 "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotens
in-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic
[EPC],Thiazides [Chemical/Ingredient]"
43353-802_5050be4b-d47d-4725-9199-caefcc088f11 43353-802 HUMAN PRESCRIPTI
olutions - Tennessee, LLC" VENLAFAXINE HYDROCHLORIDE 37.5 mg/1
43353-808_24332066-8223-4d5c-8957-5c69a287249e 43353-808 HUMAN PRESCRIPTI
ON DRUG Metoclopramide Hydrochloride Metoclopramide Hydrochloride
olutions - Tennessee, LLC" METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1
"Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC]"
43353-809_0693bc9f-ad99-415a-816e-5f3e0e33e682 43353-809 HUMAN PRESCRIPTI
ON DRUG SERTRALINE Sertraline "TABLET, FILM COATED" ORAL
ssee, LLC" SERTRALINE HYDROCHLORIDE 100 mg/1 "Serotonin Reupt
43353-811_67000fc3-2523-4e96-9b11-3ff6a6638afe 43353-811 HUMAN PRESCRIPTI
ssee, LLC" METFORMIN HYDROCHLORIDE 850 mg/1 "Biguanide [EPC],Biguani
43353-813_59a4aa04-8122-4125-95ef-b30e33c375ed 43353-813 HUMAN PRESCRIPTI
ON DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL
ssee, LLC" QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [
EPC]
EPC]
43353-815_af997b83-9a05-4373-83af-99c2745d0f73 43353-815 HUMAN PRESCRIPTI
olutions - Tennessee, LLC" ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE
80 mg/1 "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Red
uctase Inhibitors [MoA]"
EPC]
43353-819_71eaa797-a9d9-4eb6-be98-68fc6af213cc 43353-819 HUMAN PRESCRIPTI
ANDA ANDA080356 "Aphena Pharma Solutions - Tennessee, LLC" PREDNISO
NE 5 mg/1
43353-820_32c4f44c-dd59-4b03-b271-6e51d20dbf75 43353-820 HUMAN PRESCRIPTI
CIV
43353-824_6ea4aa04-8d99-4cdb-8d01-8a80ec995b70 43353-824 HUMAN PRESCRIPTI
ON DRUG FOLIC ACID FOLIC ACID TABLET ORAL 20100406
ANDA ANDA090035 "Aphena Pharma Solutions - Tennessee, LLC" FOLIC AC
ID 1 mg/1
43353-826_e3653acb-0b12-40b4-b693-9972c46af386 43353-826 HUMAN PRESCRIPTI
"Aphena Pharma Solutions - Tennessee, LLC" ATORVASTATIN CALCIUM TRIHYDRATE
43353-828_9e948241-a8c1-46e2-98c8-9c10893556b0 43353-828 HUMAN PRESCRIPTI
ON DRUG VITAMIN D ergocalciferol CAPSULE ORAL 20100315
ANDA ANDA040865 "Aphena Pharma Solutions - Tennessee, LLC" ERGOCALC
IFEROL 1.25 mg/1 "Ergocalciferols [Chemical/Ingredient],Provitamin D2 Com
pound [EPC]"
43353-829_401ad0d0-fa30-47a8-9314-9a07a05bbabc 43353-829 HUMAN PRESCRIPTI
- Tennessee, LLC" OMEPRAZOLE 40 mg/1 "Proton Pump Inhibitor [
EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]"
43353-830_cba7fa75-7b6b-4add-8a60-7dcb8557d9b5 43353-830 HUMAN PRESCRIPTI
ANDA ANDA073475 "Aphena Pharma Solutions - Tennessee, LLC" ATENOLOL
50 mg/1 "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
"
43353-831_adec9b98-1867-41a0-9288-3185c095a6fc 43353-831 HUMAN PRESCRIPTI
ON DRUG Modafinil modafinil TABLET ORAL 20120810
ANDA ANDA076594 "Aphena Pharma Solutions - Tennessee, LLC" MODAFINI
L 200 mg/1 "Central Nervous System Stimulation [PE],Increased Sympa
thetic Activity [PE],Sympathomimetic-like Agent [EPC]" CIV
43353-832_52bbd393-493f-4a64-92b3-dbb320607c1a 43353-832 HUMAN PRESCRIPTI
ssee, LLC" CARVEDILOL 25 mg/1 "Adrenergic alpha-Antagonists [M
43353-833_dac66f7f-c5e7-4781-a1d1-540604e87d76 43353-833 HUMAN PRESCRIPTI
"
43353-836_5d4b75d6-4cf4-461f-9d36-2d6eab6cccc1 43353-836 HUMAN PRESCRIPTI
43353-839_f0b71958-717d-4b8d-93ef-3f0f5f1d0c60 43353-839 HUMAN PRESCRIPTI
ON DRUG Probenecid Probenecid "TABLET, FILM COATED" ORAL
ssee, LLC" PROBENECID 500 mg/1
IN 300 mg/1 CV
Antipsychotic [EPC]
43353-848_bd5ca3e8-e294-46b9-94b4-3a66309a40b9 43353-848 HUMAN PRESCRIPTI
ON DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115
NDA NDA021436 "Aphena Pharma Solutions - Tennessee, LLC" ARIPIPRA
ZOLE 10 mg/1 Atypical Antipsychotic [EPC]
Antipsychotic [EPC]
43353-854_31cb7052-4226-4ab2-96c2-8a7fe4714d82 43353-854 HUMAN PRESCRIPTI
ON DRUG Colcrys Colchicine "TABLET, FILM COATED" ORAL 20090901
NDA NDA022352 "Aphena Pharma Solutions - Tennessee, LLC" COLCHICI
NE 0.6 mg/1 "Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Int
eractions [MoA]"
43353-856_68513fbe-c3f6-42f4-8358-589aad365109 43353-856 HUMAN PRESCRIPTI
ssee, LLC" SIMVASTATIN 40 mg/1 "HMG-CoA Reductase Inhibitor [EP
43353-857_6cb64ba8-98f2-4abf-b58f-e721f756eca6 43353-857 HUMAN PRESCRIPTI
ON DRUG Cialis Tadalafil "TABLET, FILM COATED" ORAL 20031126
NDA NDA021368 "Aphena Pharma Solutions - Tennessee, LLC" TADALAFI
L 20 mg/1 "Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5
Inhibitors [MoA]"
43353-862_c59d70ed-784f-43aa-80c6-d1e252696641 43353-862 HUMAN PRESCRIPTI
ANDA ANDA078787 "Aphena Pharma Solutions - Tennessee, LLC" GABAPENT
43353-865_43634dd1-d97c-4fb3-a9bc-b8576f449655 43353-865 HUMAN PRESCRIPTI
ON DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlo
12.5; 20 mg/1; mg/1 "Angiotensin Converting Enzyme Inhibitor [EPC],A
ngiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide D
iuretic [EPC],Thiazides [Chemical/Ingredient]"
43353-868_b1e524e2-cf67-4344-9a06-3e82920af608 43353-868 HUMAN PRESCRIPTI
ON DRUG Prazosin Hydrochloride prazosin hydrochloride CAPSULE ORAL
ssee, LLC" PRAZOSIN HYDROCHLORIDE 2 mg/1 "Adrenergic alpha-Antago
43353-869_f73c56b6-209d-4f7e-97a6-7bc119910fbb 43353-869 HUMAN PRESCRIPTI
ON DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride
74 "Aphena Pharma Solutions - Tennessee, LLC" VENLAFAXINE HYDROCHLORID
43353-870_6aaf33c1-90ec-45ad-87fe-603d794a8a0e 43353-870 HUMAN PRESCRIPTI
ON DRUG Fosinopril sodium Fosinopril sodium TABLET ORAL
ssee, LLC" FOSINOPRIL SODIUM 40 mg/1 "Angiotensin Converting
43353-872_e9ca1ee7-40fa-4579-87dc-3077b00d9718 43353-872 HUMAN PRESCRIPTI
ON DRUG GABAPENTIN gabapentin "TABLET, FILM COATED" ORAL
ssee, LLC" GABAPENTIN 600 mg/1 "Anti-epileptic Agent [EPC],Decr
IN 225 mg/1 CV
43353-879_84b17471-807e-4af9-b4ad-a20fe327860f 43353-879 HUMAN PRESCRIPTI
olutions - Tennessee, LLC" MONTELUKAST SODIUM 10 mg/1 "Leukotr
iene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]"
43353-882_f73c56b6-209d-4f7e-97a6-7bc119910fbb 43353-882 HUMAN PRESCRIPTI
74 "Aphena Pharma Solutions - Tennessee, LLC" VENLAFAXINE HYDROCHLORID
43353-883_5817ec48-bede-499e-ba77-d094e3bdd1ae 43353-883 HUMAN PRESCRIPTI
ON DRUG Valacyclovir Valacyclovir Hydrochloride "TABLET, FILM CO
olutions - Tennessee, LLC" VALACYCLOVIR HYDROCHLORIDE 500 mg/1
43353-888_5daab746-e686-48fc-a47d-ba12ec36b88f 43353-888 HUMAN PRESCRIPTI
ON DRUG diltiazem hydrochloride diltiazem hydrochloride "CAPSULE, EXTEND
1 "Aphena Pharma Solutions - Tennessee, LLC" DILTIAZEM HYDROCHLORIDE
120 mg/1 "Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]
"
"
43353-894_d7df9cc9-2bfc-458a-8a60-aecb3ee7ea6f 43353-894 HUMAN PRESCRIPTI
ON DRUG metformin hydrochloride metformin hydrochloride TABLET ORAL
C" GLYBURIDE 1.25 mg/1 "Sulfonylurea [EPC],Sulfonylurea Compoun
43353-900_d7fb489a-3230-42da-9d88-236a95d8ad1a 43353-900 HUMAN PRESCRIPTI
tors [MoA]"
"
"
"
43353-908_744f01da-309f-4cf6-b74e-27648a32a573 43353-908 HUMAN PRESCRIPTI
ON DRUG Precose Acarbose TABLET ORAL 20080130
NDA NDA020482 "Aphena Pharma Solutions - Tennessee, LLC" ACARBOSE
50 mg/1 "alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor
[EPC]"
43353-911_8992cc1b-9f28-40a5-8c95-06acb3b851b6 43353-911 HUMAN PRESCRIPTI
ON DRUG Ropinirole rOPINIRole TABLET ORAL 20080505
ANDA ANDA077852 "Aphena Pharma Solutions - Tennessee, LLC" ROPINIRO
LE HYDROCHLORIDE 2 mg/1 "Dopamine Agonists [MoA],Nonergot Dopami
ne Agonist [EPC]"
LE HYDROCHLORIDE 1 mg/1 "Dopamine Agonists [MoA],Nonergot Dopami
ne Agonist [EPC]"
43353-913_f64c95f3-04d8-4fae-98eb-7c794c449480 43353-913 HUMAN PRESCRIPTI
ON DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL
ssee, LLC" BENZTROPINE MESYLATE 0.5 mg/1 "Anticholinergic [EPC],A
ntihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists
[MoA]"
43353-914_9abef36b-8516-48fe-9420-d663cd6d9726 43353-914 HUMAN PRESCRIPTI
ON DRUG Tizanidine tizanidine TABLET ORAL 20030506
ANDA ANDA076354 "Aphena Pharma Solutions - Tennessee, LLC" TIZANIDI
NE HYDROCHLORIDE 4 mg/1 "Adrenergic alpha2-Agonists [MoA],Centra
43353-917_30b5ea6e-6e11-4381-affc-45db25bdf092 43353-917 HUMAN PRESCRIPTI
Pharma Solutions - Tennessee, LLC" ISOSORBIDE MONONITRATE 120 mg/1
"Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE]"
ANDA ANDA075078 "Aphena Pharma Solutions - Tennessee, LLC" ETODOLAC
LE HYDROCHLORIDE 0.25 mg/1 "Dopamine Agonists [MoA],Nonergot Dopami
ne Agonist [EPC]"
43353-922_238888fe-9e07-428e-b95e-4fd980ec8f8f 43353-922 HUMAN PRESCRIPTI
ON DRUG Chlorthalidone chlorthalidone TABLET ORAL 19810226
ANDA ANDA086831 "Aphena Pharma Solutions - Tennessee, LLC" CHLORTHA
LIDONE 50 mg/1 "Increased Diuresis [PE],Thiazide-like Diuretic [EPC]"
43353-923_41ea6c31-c3a7-411b-aae1-2cf7e9088f67 43353-923 HUMAN PRESCRIPTI
olutions - Tennessee, LLC" DOXYCYCLINE HYCLATE 100 mg/1
43353-924_cbcaf591-b314-4aaa-af60-5da3876e25ac 43353-924 HUMAN PRESCRIPTI
ssee, LLC" CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 "Quinolone Antim
43353-925_d1e9e94d-f917-48b2-88d5-9f9551b4cd49 43353-925 HUMAN PRESCRIPTI
ON DRUG modafinil modafinil TABLET ORAL 20120329
C" MODAFINIL 200 mg/1 "Central Nervous System Stimulation [PE]
,Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC]" CIV
43353-926_377b3679-29e3-4a57-baf1-9761ea57eefc 43353-926 HUMAN PRESCRIPTI
ON DRUG HYZAAR losartan potassium and hydrochlorothiazide "TABLET,
FILM COATED" ORAL 19950428 NDA NDA020387 "Aphena
Pharma Solutions - Tennessee, LLC" HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
43353-927_6363687c-dcff-451f-8a81-d9f04e79f9ad 43353-927 HUMAN PRESCRIPTI
ON DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL
ssee, LLC" PRAVASTATIN SODIUM 40 mg/1 "HMG-CoA Reductase Inhib
43353-933_32129338-bb18-4c4b-80a2-57ee2631feeb 43353-933 HUMAN PRESCRIPTI
ON DRUG Acyclovir acyclovir TABLET ORAL 20120921
ANDA ANDA077309 "Aphena Pharma Solutions - Tennessee, LLC" ACYCLOVI
R 800 mg/1 "DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nu
cleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside An
alog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase
Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient]"
43353-936_d7df9cc9-2bfc-458a-8a60-aecb3ee7ea6f 43353-936 HUMAN PRESCRIPTI
ON DRUG metformin hydrochloride metformin hydrochloride TABLET ORAL
43353-942_47c039de-c6d8-40fc-bae3-7a45eb9da57b 43353-942 HUMAN PRESCRIPTI
olutions - Tennessee, LLC" METOPROLOL TARTRATE 25 mg/1 "Adrener
43353-946_9abef36b-8516-48fe-9420-d663cd6d9726 43353-946 HUMAN PRESCRIPTI
ON DRUG Tizanidine tizanidine TABLET ORAL 20030506
ANDA ANDA076354 "Aphena Pharma Solutions - Tennessee, LLC" TIZANIDI
NE HYDROCHLORIDE 2 mg/1 "Adrenergic alpha2-Agonists [MoA],Centra
43353-947_de10cd2f-4523-4c70-96f3-9d238c6d74c7 43353-947 HUMAN PRESCRIPTI
olutions - Tennessee, LLC" AMANTADINE HYDROCHLORIDE 100 mg/1
"Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA]"
67544-001_90f66ef7-4b4c-4386-a1fa-56d0cbc08d1e 67544-001 HUMAN PRESCRIPTI
ON DRUG ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen and codein
"Aphena Pharma Solutions - Tennessee, LLC" ACETAMINOPHEN; CODEINE PHOSPHATE
300; 15 mg/1; mg/1 "Full Opioid Agonists [MoA],Opioid Agonist [EPC]"
CIII
CIII
CIII
67544-005_02a9e5f5-eeaf-49fa-b28d-1b1f560ea902 67544-005 HUMAN PRESCRIPTI
ANDA ANDA074112 "Aphena Pharma Solutions - Tennessee, LLC" ALPRAZOL
AM 0.25 mg/1 "Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredie
nt]" CIV
67544-012_97a0746d-58ce-4eab-8a2e-231e6988448c 67544-012 HUMAN PRESCRIPTI
ANDA ANDA040245 "Aphena Pharma Solutions - Tennessee, LLC" CARISOPR
ODOL 350 mg/1 "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxa
nt [EPC]" CIV
67544-021_f2c3a3a3-2b0d-46eb-94fb-2b708690c0eb 67544-021 HUMAN PRESCRIPTI
ANDA ANDA085762 "Aphena Pharma Solutions - Tennessee, LLC" ATROPINE
SULFATE; DIPHENOXYLATE HYDROCHLORIDE .025; 2.5 mg/1; mg/1 "Antidia
rrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Mus
carinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]" CV
67544-038_100df325-8fc5-4e54-95d9-19c8b1f81a13 67544-038 HUMAN PRESCRIPTI
M 15 mg/1 "Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredie
nt]" CIV
67544-060_de793f36-7be2-4f3e-89d9-0db5067cf561 67544-060 HUMAN PRESCRIPTI
ON DRUG Lipitor ATORVASTATIN CALCIUM "TABLET, FILM COATED" ORAL
ssee, LLC" ATORVASTATIN CALCIUM 80 mg/1 "HMG-CoA Reductase Inhib
67544-075_ca0bf468-958c-439f-9568-defb902354cf 67544-075 HUMAN PRESCRIPTI
[EPC]"
67544-078_31bfccac-afec-4ca6-aa1f-024e6e54aff3 67544-078 HUMAN PRESCRIPTI
olutions - Tennessee, LLC" NORTRIPTYLINE HYDROCHLORIDE 25 mg/1
67544-080_bedd246d-d8fe-4d00-98bd-8042d81f964b 67544-080 HUMAN PRESCRIPTI
ON DRUG Zoloft SERTRALINE HYDROCHLORIDE "TABLET, FILM COATED"
- Tennessee, LLC" SERTRALINE HYDROCHLORIDE 100 mg/1 "Seroton
67544-085_0c1f0c4b-ed50-47ad-94a6-98a47ead9315 67544-085 HUMAN PRESCRIPTI
"Aphena Pharma Solutions - Tennessee, LLC" AMITRIPTYLINE HYDROCHLORIDE
25 mg/1 Tricyclic Antidepressant [EPC]
67544-087_74ba9277-cf16-4079-ad5b-b444357bf663 67544-087 HUMAN PRESCRIPTI
"
67544-097_b9b84358-3975-4cee-a86f-7c61c2c0f55e 67544-097 HUMAN PRESCRIPTI
ANDA ANDA074305 "Aphena Pharma Solutions - Tennessee, LLC" GLIPIZID
E 10 mg/1 "Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ing
redient]"
67544-102_cb3df109-9a12-43f9-b1dd-99e156d81b11 67544-102 HUMAN PRESCRIPTI
orothiazide TABLET ORAL 20110209 NDA NDA019129
"Aphena Pharma Solutions - Tennessee, LLC" HYDROCHLOROTHIAZIDE; TRIAMTERENE
50; 75 mg/1; mg/1 "Decreased Renal K+ Excretion [PE],Increased Diuresis [P
E],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [E
PC],Thiazides [Chemical/Ingredient]"
67544-106_8eccf91e-8dd6-406a-bfe2-a45d49012d13 67544-106 HUMAN PRESCRIPTI
67544-117_e3c09b61-e055-476c-b814-9ef152507f28 67544-117 HUMAN PRESCRIPTI
- Tennessee, LLC" OXAZEPAM 10 mg/1 "Benzodiazepine [EPC],Be
67544-127_20ae218f-ccab-4c28-98c0-1a41b8e8f008 67544-127 HUMAN PRESCRIPTI
nt]" CIV
67544-136_349eedc7-991d-4012-9c58-0179f7350568 67544-136 HUMAN PRESCRIPTI
nt]" CIV
67544-142_3437598f-3128-4bd3-a0e5-f55b485dee04 67544-142 HUMAN PRESCRIPTI
ANDA ANDA072928 "Aphena Pharma Solutions - Tennessee, LLC" LORAZEPA
nt]" CIV
67544-154_c3fb8c8c-fa8d-4890-a843-1999add4d22b 67544-154 HUMAN PRESCRIPTI
ON DRUG Klor-Con Potassium Chloride "TABLET, FILM COATED, EX
TENDED RELEASE" ORAL 19860417 NDA NDA019123 "Aphena
Pharma Solutions - Tennessee, LLC" POTASSIUM CHLORIDE 600 mg/1
"
67544-185_28f2a162-654f-48d1-b0d8-41e06d8eca95 67544-185 HUMAN PRESCRIPTI
ON DRUG Adalat CC nifedipine "TABLET, FILM COATED" ORAL
ssee, LLC" NIFEDIPINE 90 mg/1 "Calcium Channel Antagonists [Mo
edient]"
nt]" CIV
67544-204_a427cdfd-7e1f-4f7c-ba6a-167e56d9d340 67544-204 HUMAN PRESCRIPTI
NDA NDA020998 "Aphena Pharma Solutions - Tennessee, LLC" CELECOXI
B 200 mg/1 "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-infla
]"
67544-217_20ae218f-ccab-4c28-98c0-1a41b8e8f008 67544-217 HUMAN PRESCRIPTI
nt]" CIV
67544-224_4c645cf7-1073-45c1-a01f-537f067833f2 67544-224 HUMAN PRESCRIPTI
67544-236_74bda58d-0659-4d1d-b968-a2d3fbf6e50d 67544-236 HUMAN PRESCRIPTI
67544-237_c3fb8c8c-fa8d-4890-a843-1999add4d22b 67544-237 HUMAN PRESCRIPTI
ON DRUG Klor-Con Potassium Chloride "TABLET, FILM COATED, EX
TENDED RELEASE" ORAL 19860417 NDA NDA019123 "Aphena
Pharma Solutions - Tennessee, LLC" POTASSIUM CHLORIDE 750 mg/1
67544-247_de793f36-7be2-4f3e-89d9-0db5067cf561 67544-247 HUMAN PRESCRIPTI
ON DRUG Lipitor ATORVASTATIN CALCIUM "TABLET, FILM COATED" ORAL
ssee, LLC" ATORVASTATIN CALCIUM 40 mg/1 "HMG-CoA Reductase Inhib
67544-250_2c24af9b-48af-4f5b-b4e5-50e0f2f87ed7 67544-250 HUMAN PRESCRIPTI
ON DRUG Lisinopril and Hydrochlorothiazide lisinopril and hydrochlo
67544-251_a5cc3bc3-6e0e-4c01-b631-c927413f459b 67544-251 HUMAN PRESCRIPTI
"Aphena Pharma Solutions - Tennessee, LLC" CYCLOBENZAPRINE HYDROCHLORIDE
10 mg/1 "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
"
67544-252_a6d39b9c-024a-4c09-b0c3-263456317fb4 67544-252 HUMAN PRESCRIPTI
- Tennessee, LLC" PENTOXIFYLLINE 400 mg/1 "Blood Viscosity Reducer
[EPC],Hematologic Activity Alteration [PE]"
nt]" CIV
67544-268_e3c09b61-e055-476c-b814-9ef152507f28 67544-268 HUMAN PRESCRIPTI
- Tennessee, LLC" OXAZEPAM 15 mg/1 "Benzodiazepine [EPC],Be
67544-273_dd9b82e8-41a2-469e-b6fb-2332a1a38912 67544-273 HUMAN PRESCRIPTI
rgic Blocker [EPC]"
67544-276_8630b890-129e-4ef3-b8cb-afc47305a71e 67544-276 HUMAN PRESCRIPTI
ON DRUG Lisinopril with Hydrochlorothiazide Lisinopril and Hydrochlo
67544-287_349eedc7-991d-4012-9c58-0179f7350568 67544-287 HUMAN PRESCRIPTI
nt]" CIV
67544-289_23891fcd-df44-428d-b328-335ca1b7c777 67544-289 HUMAN PRESCRIPTI
nt]" CIV
nt]" CIV
67544-298_bedd246d-d8fe-4d00-98bd-8042d81f964b 67544-298 HUMAN PRESCRIPTI
ON DRUG Zoloft SERTRALINE HYDROCHLORIDE "TABLET, FILM COATED"
- Tennessee, LLC" SERTRALINE HYDROCHLORIDE 50 mg/1 "Seroton
nt]" CIV
67544-302_b9b84358-3975-4cee-a86f-7c61c2c0f55e 67544-302 HUMAN PRESCRIPTI
ANDA ANDA074305 "Aphena Pharma Solutions - Tennessee, LLC" GLIPIZID
E 5 mg/1 "Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ing
redient]"
67544-318_7092a87a-54fb-4f82-8f58-0a950bf0db3d 67544-318 HUMAN PRESCRIPTI
67544-326_045a1d78-1ac0-4f65-958e-8777ab4b1cf2 67544-326 HUMAN PRESCRIPTI
"
"
67544-338_5d3ad7cd-d844-49b9-adde-a05f12d0ea8a 67544-338 HUMAN PRESCRIPTI
67544-346_5d3ad7cd-d844-49b9-adde-a05f12d0ea8a 67544-346 HUMAN PRESCRIPTI
67544-353_03cba200-f94b-4357-bee2-b32b12f19891 67544-353 HUMAN PRESCRIPTI
67544-355_adc5a44a-091a-4541-95af-9e3ec75f0eef 67544-355 HUMAN PRESCRIPTI
67544-356_adc5a44a-091a-4541-95af-9e3ec75f0eef 67544-356 HUMAN PRESCRIPTI
67544-373_100df325-8fc5-4e54-95d9-19c8b1f81a13 67544-373 HUMAN PRESCRIPTI
nt]" CIV
67544-394_68d8e3a9-cabb-46aa-b327-9d024d41a6e7 67544-394 HUMAN PRESCRIPTI
ON DRUG "Butalbital, Acetaminophen and Caffeine" "Butalbital, Ace
ANDA040511 "Aphena Pharma Solutions - Tennessee, LLC" ACETAMINOPHEN; B
UTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 "Barbiturate [EP
C],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Cen
tral Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/In
gredient]"
67544-403_948ffea7-be2c-4b21-9880-8e27af9a4090 67544-403 HUMAN PRESCRIPTI
ON DRUG Diovan valsartan TABLET ORAL 20010701
NDA NDA021283 "Aphena Pharma Solutions - Tennessee, LLC" VALSARTA
N 80 mg/1 "Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2
Receptor Blocker [EPC]"
67544-404_948ffea7-be2c-4b21-9880-8e27af9a4090 67544-404 HUMAN PRESCRIPTI
ON DRUG Diovan valsartan TABLET ORAL 20010701
NDA NDA021283 "Aphena Pharma Solutions - Tennessee, LLC" VALSARTA
N 160 mg/1 "Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2
67544-408_cb3df109-9a12-43f9-b1dd-99e156d81b11 67544-408 HUMAN PRESCRIPTI
orothiazide TABLET ORAL 20110209 NDA NDA019129
"Aphena Pharma Solutions - Tennessee, LLC" HYDROCHLOROTHIAZIDE; TRIAMTERENE
25; 37.5 mg/1; mg/1 "Decreased Renal K+ Excretion [PE],Increased Diu
resis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diu
retic [EPC],Thiazides [Chemical/Ingredient]"
nt]" CIV
67544-431_da02b76d-00ea-4733-aef8-7808b0b45d47 67544-431 HUMAN PRESCRIPTI
ON DRUG Fosinopril sodium Fosinopril sodium TABLET ORAL
ssee, LLC" FOSINOPRIL SODIUM 20 mg/1 "Angiotensin Converting
67544-456_81d7938c-6dd1-4368-a5fc-0b7b6c2b2ded 67544-456 HUMAN PRESCRIPTI
67544-464_75f35191-7de2-4503-a06e-134999aa98b9 67544-464 HUMAN PRESCRIPTI
Pharma Solutions - Tennessee, LLC" BUPROPION HYDROCHLORIDE 100 mg/1
"Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity
[PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [Mo
A]"
67544-468_c6cea106-a61e-4ee6-9961-c0e89109c372 67544-468 HUMAN OTC DRUG
Regular Strength Aspirin EC Aspirin "TABLET, DELAYED RELEASE"
ORAL 20110909 OTC MONOGRAPH FINAL part343 "Aphena Pharma S
olutions - Tennessee, LLC" ASPIRIN 325 mg/1
67544-474_6d0a1553-38cf-41c5-a7a4-1d738112d94c 67544-474 HUMAN PRESCRIPTI
ate TABLET ORAL 19880930 ANDA ANDA089828 "Aphena
Pharma Solutions - Tennessee, LLC" ACETAMINOPHEN; CODEINE PHOSPHATE
CIII
67544-479_4c40fbad-f018-45a5-813f-5a7dca18c9a6 67544-479 HUMAN PRESCRIPTI
ON DRUG Valproic Acid valproic acid CAPSULE ORAL 19911029
ANDA ANDA073229 "Aphena Pharma Solutions - Tennessee, LLC" VALPROIC
ACID 250 mg/1 "Anti-epileptic Agent [EPC],Decreased Central Nervous Sy
67544-510_6651d00a-865c-49c9-aa6f-b67b20893c1c 67544-510 HUMAN PRESCRIPTI
- Tennessee, LLC" OMEPRAZOLE 20 mg/1 "Proton Pump Inhibitor [
EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]"
67544-524_4022ec92-1e3c-40a7-9a23-e28f40e79a12 67544-524 HUMAN OTC DRUG
Aspirin EC Aspirin "TABLET, COATED" ORAL 19940205
OTC MONOGRAPH FINAL part343 "Aphena Pharma Solutions - Tennessee, LLC"
ASPIRIN 81 mg/1
67544-562_e880cdbb-908e-45e2-83c7-0742a66a1ef0 67544-562 HUMAN PRESCRIPTI
ON DRUG Terazosin hydrochloride Terazosin Hydrochloride CAPSULE ORAL
ssee, LLC" TERAZOSIN HYDROCHLORIDE 2 mg/1 "Adrenergic alpha-Antago
67544-567_f3bcf3f8-72ce-4359-877e-13cef7ecf1c1 67544-567 HUMAN PRESCRIPTI
67544-568_7a2b5130-7c3c-4407-94dc-085e4e3652d1 67544-568 HUMAN PRESCRIPTI
ANDA ANDA070086 "Aphena Pharma Solutions - Tennessee, LLC" FUROSEMI
[EPC]"
67544-570_37fa075f-798b-4335-8f5f-d76d513acdd8 67544-570 HUMAN PRESCRIPTI
ON DRUG Pacerone Amiodarone Hydrochloride TABLET ORAL
ssee, LLC" AMIODARONE HYDROCHLORIDE 200 mg/1 "Antiarrhythmic
[EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytoc
hrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome
P450 2D6 Inhibitors [MoA]"
nt]" CIV
67544-655_88c9255c-f367-4bfa-9179-15d0ac6d326a 67544-655 HUMAN OTC DRUG
Bisacodyl Enteric Coated Bisacodyl "TABLET, COATED" ORAL
20081024 OTC MONOGRAPH NOT FINAL part334 "Aphena Pharma Solutions
- Tennessee, LLC" BISACODYL 5 mg/1
67544-656_7bba784e-b2dd-4662-a66d-09246be23c7c 67544-656 HUMAN PRESCRIPTI
ON DRUG Renagel Renagel TABLET ORAL 20080606 NDA
NDA021179 "Aphena Pharma Solutions - Tennessee, LLC" SEVELAMER HYDROC
HLORIDE 800 mg/1 "Phosphate Binder [EPC],Phosphate Chelating Activity [Mo
A]"
67544-697_37c91b72-c47b-4200-a66a-2f3a24de2e43 67544-697 HUMAN PRESCRIPTI
nt]" CIV
67544-700_b13be519-3c63-40cb-a3ee-66ec6238310f 67544-700 HUMAN PRESCRIPTI
ON DRUG Loperamide Hydrochloride loperamide hydrochloride
olutions - Tennessee, LLC" LOPERAMIDE HYDROCHLORIDE 2 mg/1
"Opioid Agonist [EPC],Opioid Agonists [MoA]"
67544-720_d6b6a9b8-aa6a-4b5d-b5ce-564b858d67e9 67544-720 HUMAN PRESCRIPTI
CIV
67544-807_b6848545-e2e1-40d1-aa7e-e5f6100b9edd 67544-807 HUMAN PRESCRIPTI
ON DRUG Piroxicam Piroxicam CAPSULE ORAL 19940126
ANDA ANDA074131 "Aphena Pharma Solutions - Tennessee, LLC" PIROXICA
M 20 mg/1 "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-infla
]"
67544-848_b6d3beec-9ded-46ae-9122-462504bf2741 67544-848 HUMAN PRESCRIPTI
ON DRUG Fluoxetine Hydrochloride Fluoxetine Hydrochloride
olutions - Tennessee, LLC" FLUOXETINE HYDROCHLORIDE 20 mg/1
67544-870_dc10ad3e-db44-4346-8945-fe25b0999f9f 67544-870 HUMAN PRESCRIPTI
ON DRUG Lorazepam lorazepam TABLET ORAL 20130305
nt]" CIV
nt]" CIV
67544-882_6d0a1553-38cf-41c5-a7a4-1d738112d94c 67544-882 HUMAN PRESCRIPTI
ate TABLET ORAL 19880930 ANDA ANDA089805 "Aphena
Pharma Solutions - Tennessee, LLC" ACETAMINOPHEN; CODEINE PHOSPHATE
CIII
67544-892_4656613f-ab12-4d5f-a7ad-573b6f0e2e3a 67544-892 HUMAN PRESCRIPTI
olutions - Tennessee, LLC" BUPROPION HYDROCHLORIDE 75 mg/1 "Aminoke
nt]" CIV
53401-100_660693fd-25d3-485a-86b6-0ef4bda647ce 53401-100 HUMAN PRESCRIPTI
ON DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET ORAL
20110714 ANDA ANDA062505 Aphena Pharma Solutions (Formerl
y TestPak) DOXYCYCLINE HYCLATE 100 mg/1
52380-0039_4f77b387-b064-4d15-a0ac-76e77c10e756 52380-0039 HUMAN OTC DRUG
Aplicare ExCel AP Povidone-iodine Alcohol SOLUTION TOPICAL
20040601 OTC MONOGRAPH NOT FINAL part333A Aplicare
ISOPROPYL ALCOHOL; POVIDONE-IODINE 507; 77.31 mg/mL; mg/mL
52380-0001_6b7041cc-f356-4731-9b98-7230f0ea5130 52380-0001 HUMAN OTC DRUG
Aplicare Povidone Iodine Swabstick POVIDONE-IODINE SOLUTION
TOPICAL 19840301 OTC MONOGRAPH NOT FINAL part333A "Aplicar
e, Inc." POVIDONE-IODINE 9.8 mg/mL
52380-0005_32e54b08-576d-478e-8324-084247124d1b 52380-0005 HUMAN OTC DRUG
Aplicare Isopropyl Alcohol Isopropyl Alcohol SOLUTION
TOPICAL 19850101 OTC MONOGRAPH NOT FINAL part333 "Aplicare, Inc."
ISOPROPYL ALCOHOL 70 mL/100mL
52380-0013_58120b6c-7e5b-49ff-9e26-a912357366d1 52380-0013 HUMAN OTC DRUG
Aplicare Hydrogen Peroxide Hydrogen Peroxide LIQUID TOPICAL
19831201 OTC MONOGRAPH NOT FINAL part333 "Aplicare, Inc."
HYDROGEN PEROXIDE 3 mL/100mL
52380-0024_6e61bf62-5508-47db-812b-159facf6f1ac 52380-0024 HUMAN OTC DRUG
Aplicare Povidone-Iodine Scrub Sponges Povidone-iodine Scrub Sponges
SOLUTION TOPICAL 19920701 OTC MONOGRAPH NOT FINAL part333
"Aplicare, Inc." POVIDONE-IODINE 9.7 g/100g
52380-0025_dc616e0d-2478-41ed-b70c-3250039352b4 52380-0025 HUMAN OTC DRUG
Aplicare Povidone-iodine Scrub Povidone-iodine SOLUTION TOPICAL
POVIDONE-IODINE 8.1 g/100g
52380-0026_ef94e673-daba-4bc0-ae0c-56c46ded5d9d 52380-0026 HUMAN OTC DRUG
Aplicare Povidone-Iodine Povidone-Iodine Ointment OINTMENT
52380-0038_4087a9ab-a928-4d7e-bcbd-0a31b3bb9c3d 52380-0038 HUMAN OTC DRUG
Aplicare Povidone Iodine Swabstick Povidone Iodine GEL TOPICAL
POVIDONE-IODINE 10 g/100g
52380-0101_4a68b199-f8ec-4144-bccd-b24db05377f4 52380-0101 HUMAN OTC DRUG
Aplicare Povidone-Iodine Sponge Povidone-Iodine Sponge SOLUTION
52380-0540_fcd4aef5-70b8-4889-ac0a-33977221c061 52380-0540 HUMAN OTC DRUG
Aplicare Antiseptic Hand Rinse Ethanol GEL TOPICAL 20060801
OTC MONOGRAPH NOT FINAL part333A "Aplicare, Inc." ALCOHOL 0.62
mL/mL
52380-1101_b3b7bc4c-6a47-4a8c-942d-e959ce7340b6 52380-1101 HUMAN OTC DRUG
Aplicare Povidone Iodine Swabstick POVIDONE-IODINE SOLUTION
e, Inc." POVIDONE-IODINE 10 mg/mL
52380-1102_9fb000bc-8d10-4cd8-a320-1f3d66c863ca 52380-1102 HUMAN OTC DRUG
Aplicare Povidone-iodine Scrub Triples Povidone-iodine SOLUTION
52380-1272_d0be6895-2ede-41aa-b39e-3380c61c8687 52380-1272 HUMAN OTC DRUG
Aplicare Antiseptic Chlorhexidine Gluconate Chlorhexidine Gluconate
SOLUTION TOPICAL 19980901 NDA NDA019125 "Aplicar
e, Inc." CHLORHEXIDINE GLUCONATE 4 g/100g
52380-1274_f9bac287-2fea-404f-96e7-1c3dd8b8aac3 52380-1274 HUMAN OTC DRUG
Aplicare Antiseptic Chlorhexidine Gluconate Chlorhexidine Gluconate
SOLUTION TOPICAL 19980901 NDA NDA019422 "Aplicar
e, Inc." CHLORHEXIDINE GLUCONATE 2 g/100g
52380-1614_3f02bcb8-cd7a-40fc-8bcf-492302cb1fea 52380-1614 HUMAN OTC DRUG
Aplicare Antiseptic Hand Rinse Ethanol GEL TOPICAL 19980901
OTC MONOGRAPH NOT FINAL part333A "Aplicare, Inc." ALCOHOL 62
mL/100mL
52380-1617_c3e5f62f-6fe8-42eb-862b-de0536c30570 52380-1617 HUMAN OTC DRUG
Aplicare Antiseptic Perineal Wash II Benzethonium Chloride SOLUTION
BENZETHONIUM CHLORIDE 0.2 1/100g
52380-1721_88c8640e-4318-4acc-ae5c-f76c281bfec2 52380-1721 HUMAN OTC DRUG
Aplicare Povidone-iodine Povidone-iodine SOLUTION TOPICAL
19980901 OTC MONOGRAPH NOT FINAL part333A "Aplicare, Inc."
POVIDONE-IODINE 10 g/100g
52380-1730_6780f5fe-51e5-4637-b049-389f557aadb9 52380-1730 HUMAN OTC DRUG
Aplicare Povidone-iodine Povidone-iodine DOUCHE VAGINAL 19980901
OTC MONOGRAPH NOT FINAL part333 "Aplicare, Inc." POVIDONE-IODINE 10
g/100g
52380-1738_bee255a7-e148-43d1-9539-2681b035c46b 52380-1738 HUMAN OTC DRUG
Aplicare Povidone Iodine Povidone Iodine GEL TOPICAL 19980901
OTC MONOGRAPH NOT FINAL part333 "Aplicare, Inc." POVIDONE-IODINE 10
g/100g
52380-1771_24dd38b6-9e89-4527-8702-d1d4fe81ed23 52380-1771 HUMAN OTC DRUG
Aplicare Isopropyl Alcohol Isopropyl Alcohol GEL TOPICAL
ISOPROPYL ALCOHOL 70 mL/100mL
52380-1845_76291767-ebfd-42aa-8316-8edc7c0f479c 52380-1845 HUMAN OTC DRUG
Aplicare Physicians Antibacterial Triclosan LIQUID TOPICAL
TRICLOSAN 0.3 g/100g
52380-1855_a381be21-af69-4483-9eae-e899c65e40e0 52380-1855 HUMAN OTC DRUG
52380-1865_f09a3365-8cd6-4daf-9033-b5e6963e0d9e 52380-1865 HUMAN OTC DRUG
Antibacterial Lotion Soap Triclosan LIQUID TOPICAL 19980901
OTC MONOGRAPH NOT FINAL part333 "Aplicare, Inc." TRICLOSAN 0.3
g/100g
52380-1880_580116d0-1677-4fcd-a188-cac8f00c1996 52380-1880 HUMAN OTC DRUG
Aplicare Povidone-iodine Perineal Wash Povidone-iodine Perineal Wash
LIQUID TOPICAL 19980901 OTC MONOGRAPH NOT FINAL part333 "Aplicar
e, Inc." POVIDONE-IODINE 10 1/100g
52380-1905_6424fbd1-d6bd-400d-9fc5-d683622d310b 52380-1905 HUMAN OTC DRUG
Aplicare Povidone-Iodine Povidone-Iodine SOLUTION TOPICAL
52380-2801_0663c29f-9e8e-4330-9dd1-a5f13ef94614 52380-2801 HUMAN OTC DRUG
52380-2802_c82f5661-77d7-4eb9-93e6-34124b17d6de 52380-2802 HUMAN OTC DRUG
52380-3101_8f3416fc-f8f5-4fdd-b7ca-23e5df3fc21c 52380-3101 HUMAN OTC DRUG
Aplicare Povidone-iodine Triples Povidone-iodine SOLUTION
e, Inc." POVIDONE-IODINE 10 mg/mL
52380-3102_4bd7b803-100a-4cb0-bb5c-768bc5f1e2ec 52380-3102 HUMAN OTC DRUG
52380-3191_d314c1ac-8b7a-4978-9c4c-936ddb17a84e 52380-3191 HUMAN OTC DRUG
Curity Povidone-Iodine Paint Povidone-Iodine SOLUTION TOPICAL
POVIDONE-IODINE 9.5 g/mL
52380-4193_23aa7649-419e-4e68-a700-26cdc1557f16 52380-4193 HUMAN OTC DRUG
Curity Povidone-Iodine One-Step Prep Povidone-Iodine GEL TOPICAL
52380-4801_4ad436ec-3aa6-4410-9132-c75c19a15c6f 52380-4801 HUMAN OTC DRUG
52380-4802_2801b144-89a1-4fe9-9a4a-8df96b09b6a8 52380-4802 HUMAN OTC DRUG
52380-4892_a4748740-ce76-4211-8957-f3e87ada6345 52380-4892 HUMAN OTC DRUG
Curity Povidone-Iodine Scrub Povidone-Iodine SOLUTION TOPICAL
52380-7310_f097e630-cfad-47ce-bb53-3ec07c3d0943 52380-7310 HUMAN OTC DRUG
Aplicare Total Joint Prep Povidone-iodine KIT TOPICAL 20111201
OTC MONOGRAPH NOT FINAL part333A "Aplicare, Inc."
52380-9957_7430a4e0-3952-4fe5-8a6b-dcd461fe6bcb 52380-9957 HUMAN OTC DRUG
PCMX with Emollient Chloroxylenol SOLUTION TOPICAL 20040501
OTC MONOGRAPH NOT FINAL part333 "Aplicare, Inc." CHLOROXYLENOL 3.3
kg/100kg
63148-118_d3e90fc2-15ab-4d26-b51f-58eaa9a5faa7 63148-118 HUMAN OTC DRUG
PRICE CHOPPER PUMPKIN SPICE ANTIBACTERIAL FOAMING TRICLOSAN LIQUID
TOPICAL 20140605 OTC MONOGRAPH NOT FINAL part333E APOLLO H
EALTH AND BEAUTY CARE TRICLOSAN 4.6 mg/mL
63148-140_8d28c156-5e49-4d3f-959c-e6e8640da049 63148-140 HUMAN OTC DRUG
ANTIBACTERIAL HAND SOAP WITH LIGHT MOISTURIZERS TRICLOSAN LOTION TOPICAL
20100224 OTC MONOGRAPH NOT FINAL part333 APOLLO HEALTH AND BEAUTY
CARE TRICLOSAN 0.115 mL/100mL
63148-141_00009b19-6d96-435d-8dc2-13432b12ee9e 63148-141 HUMAN OTC DRUG
ANTIBACTERIAL HAND SOAP WITH LIGHT MOISTURIZERS TRICLOSAN LOTION TOPICAL
CARE TRICLOSAN 0.115 mL/100mL
63148-164_981ecab8-cd2c-4d72-90e0-d9d8bf60c819 63148-164 HUMAN OTC DRUG
ANTIBACTERIAL FOAMING POMEGRANATE TRICLOSAN LIQUID TOPICAL 20100706
OTC MONOGRAPH NOT FINAL part333 Apollo Health and Beauty Care TRICLOSAN
0.46 mL/100mL
63148-165_bf09bb77-1853-4b0e-a3d2-c4f0162f1b32 63148-165 HUMAN OTC DRUG
CARE ONE Antibacterial Foaming Hand Soap Green Tea Triclosan
LIQUID TOPICAL 20090717 OTC MONOGRAPH NOT FINAL part333 Apollo H
ealth and Beauty Care TRICLOSAN 0.46 mL/100mL
63148-167_c2ac7051-2f25-414a-a367-54fe55ce541f 63148-167 HUMAN OTC DRUG
Foaming Antibacterial Cucumber Melon Triclosan LIQUID TOPICAL 20111026
OTC MONOGRAPH NOT FINAL part333E Apollo Health and Beauty Care TRICLOSA
N 0.6 mL/100mL
63148-173_f865e380-74bc-4e4f-a4a0-c1d749796b87 63148-173 HUMAN OTC DRUG
FOAMING ANTIBACTERIAL PLUMERIA TRICLOSAN SOAP TOPICAL 20100720
OTC MONOGRAPH NOT FINAL part333 APOLLO HEALTH AND BEAUTY CARE TRICLOSAN
0.6 mL/100mL
63148-215_0d880a28-6433-43cf-81d9-12f12ca88be1 63148-215 HUMAN OTC DRUG
Antibacterial Mandarin and Grapefruit Handsoap Gentle Cleansing Formula
TRICLOSAN LIQUID TOPICAL 20100628 OTC MONOGRAPH NOT FINAL
part333 Apollo Health and Beauty Care TRICLOSAN 0.15 mL/100mL
63148-225_7fee5284-8e16-4511-8e94-daf556137e7f 63148-225 HUMAN OTC DRUG
INSTANT HAND SANITIZER WITH MOISTURIZERS AND VITAMIN E ETHYL ALCOHOL GEL
TOPICAL 20100705 OTC MONOGRAPH NOT FINAL part333 APOLLO HEALTH AN
D BEAUTY CARE ALCOHOL 62 mL/100mL
63148-225_8c1aea5c-a193-4abc-a50b-4fda78d92818 63148-225 HUMAN OTC DRUG
INSTANT HAND SANITIZER WITH MOISTURIZERS AND VITAMIN E ETHYL ALCOHOL GEL
63148-240_b035432f-f0d7-42d5-b132-2e4fb2674032 63148-240 HUMAN OTC DRUG
FOAMING HAND SANITIZER WITH ALOE BENZALKONIUM CHLORIDE LIQUID TOPICAL
CARE BENZALKONIUM CHLORIDE 0.1 mL/100mL
63148-241_54677fac-cf5e-4cdd-a77c-5780a69ba972 63148-241 HUMAN OTC DRUG
ANTIMICROBIAL FOAMING FALLING RAIN BENZETHONIUM CHLORIDE LIQUID TOPICAL
20110722 OTC MONOGRAPH NOT FINAL part333E APOLLO HEALTH AN
D BEAUTY CARE BENZETHONIUM CHLORIDE 0.1 mL/100mL
63148-250_00a86e8f-dc4e-4125-bf56-bd361c424899 63148-250 HUMAN OTC DRUG
CVS PHARMACY INSTANT HAND SANITIZER FRESH SCENT ETHYL ALCOHOL GEL
TOPICAL 20091010 OTC MONOGRAPH NOT FINAL part333 Apollo Health an
d Beauty Care ALCOHOL 62 mL/100mL
63148-251_3ff94d36-7237-448f-bb7b-5d8d4a39b013 63148-251 HUMAN OTC DRUG
CVS PHARMACY ANTI-AGING HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL
20091020 OTC MONOGRAPH NOT FINAL part333 Apollo Health and Beauty
Care ALCOHOL 62 mL/100mL
63148-252_51834035-0a13-4d92-a608-43b7d23a44b3 63148-252 HUMAN OTC DRUG
CVS Pharmacy FOAM HAND SANITIZER WITH ALOE ETHYL ALCOHOL LIQUID TOPICAL
20091217 OTC MONOGRAPH NOT FINAL part333 Apollo Health and Beauty
Care ALCOHOL 70 mL/100mL
63148-253_677a3bd4-f63f-467b-9de2-e08900b8e987 63148-253 HUMAN OTC DRUG
CVS PHARMACY INSTANT HAND SANITIZER WITH MOISTURIZERS AND VITAMIN E ETHYL AL
COHOL GEL TOPICAL 20091010 OTC MONOGRAPH NOT FINAL part333
Apollo Health and Beauty Care ALCOHOL 65 mL/100mL
63148-258_4cfcba2a-a6bc-4e1b-a546-3c7853f15f21 63148-258 HUMAN OTC DRUG
HAND SANITIZER CITRUS COCONUT with moisture beads ETHYL ALCOHOL GEL
63148-259_7882c344-2b45-46de-af0e-f828f29b6ac2 63148-259 HUMAN OTC DRUG
HAND SANITIZER PASSION FLOWER with moisture beads ETHYL ALCOHOL GEL
63148-261_a524f129-150a-483c-8e18-00ea1aca338b 63148-261 HUMAN OTC DRUG
HAND SANITIZER SUN BLOSSOM with moisture beads ETHYL ALCOHOL GEL TOPICAL
CARE ALCOHOL 62 mL/100mL
63148-262_540a79ad-8727-4721-8045-5f900054702b 63148-262 HUMAN OTC DRUG
HAND SANITIZER POMEGRANATE APPLE with moisture beads ETHYL ALCOHOL GEL
63148-269_3df5a074-1fdc-4b7a-af72-35b7bcd7f131 63148-269 HUMAN OTC DRUG
ANTIBACTERIAL HAND SANITIZER BASIL AND GREEN TEA ETHYL ALCOHOL GEL
EALTH AND BEAUTY CARE ALCOHOL 62 mL/100mL
63148-270_50f99008-5d7c-4bbb-a500-223b23363e81 63148-270 HUMAN OTC DRUG
ANTIBACTERIAL HAND SANITIZER SUNFLOWER AND CITRUS ETHYL ALCOHOL GEL
63148-271_4280f663-da2f-4cbb-91bb-7b29718d61e7 63148-271 HUMAN OTC DRUG
ANTIBACTERIAL HAND SANITIZER POMEGRANATE AND ACAI ETHYL ALCOHOL GEL
63148-320_ee252b4a-8893-40eb-98c2-5050a432cdd9 63148-320 HUMAN OTC DRUG
SKIN MOISTURIZING WITH NATURAL COLLOIDAL OATMEAL DIMETHICONE LOTION
TOPICAL 20100625 OTC MONOGRAPH FINAL part347 APOLLO HEALTH AN
D BEAUTY CARE DIMETHICONE 1.25 mL/100mL
63148-330_5ff46716-6084-416e-9026-e4cc90a879ae 63148-330 HUMAN OTC DRUG
HYDRATING HEALING DAILY THRAPY PETROLATUM OINTMENT TOPICAL
20100719 OTC MONOGRAPH FINAL part347 APOLLO HEALTH AND BEAUTY
CARE PETROLATUM 41 g/100g
63148-418_b94730e1-3d0f-4bea-a4ba-a8c290bb5695 63148-418 HUMAN OTC DRUG
DANDRUFF SHAMPOO AND CONDITIONER WITH CUCUMBER AND LEMONGRASS EXTRACTS
PYRITHIONE ZINC LOTION/SHAMPOO TOPICAL 20100308 OTC MONOGRAPH FI
NAL part358 APOLLO HEALTH AND BEAUTY CARE PYRITHIONE ZINC 1 mL/100mL
63148-422_88c771f3-12c7-4877-8ed8-f4961bb10252 63148-422 HUMAN OTC DRUG
ANTI-DANDRUFF SHAMPOO AND CONDITIONER HOWL PYRITHIONE ZINC LOTION/SHAMPOO
TOPICAL 20100308 OTC MONOGRAPH FINAL part358 Apollo Health an
d Beauty Care PYRITHIONE ZINC 1 mL/100mL
63148-556_178eb802-d15c-4886-9113-b83e55176dc0 63148-556 HUMAN OTC DRUG
MARCS ORIGINAL "EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL"
LIQUID ORAL 20140213 OTC MONOGRAPH NOT FINAL part356 APOLLO H
EALTH AND BEAUTY CARE EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42
; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL
63148-557_cab8004b-b0eb-4d57-adcc-b3edf5fae46c 63148-557 HUMAN OTC DRUG
MARCS BLUE MINT "EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL"
63148-558_350b0901-4a78-46fb-a11c-a11321773616 63148-558 HUMAN OTC DRUG
MARCS SPRING MINT "EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL"
63148-801_c0f5a6ac-3714-4da1-9610-5cb77832b473 63148-801 HUMAN OTC DRUG
Natural Concept Body Wash Spring Breeze Triclosan SOAP TOPICAL
20100922 OTC MONOGRAPH NOT FINAL part333E Apollo Health an
d Beauty Care TRICLOSAN 0.15 mL/100mL
63148-804_22066d6b-8e5c-4a38-a5a5-4ce84ef7a9fb 63148-804 HUMAN OTC DRUG
SPARKLING MIST ANTIBACTERIAL CLEANSER WITH MOISTURIZERS TRICLOSAN
LOTION TOPICAL 20100715 OTC MONOGRAPH NOT FINAL part333 Apollo H
ealth and Beauty Care TRICLOSAN 0.15 mL/100mL
24781-0001_7aa76967-8f9f-4d38-8389-1723c0a00212 24781-0001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS Apollo Services Inc. OXYGEN 99 L/100L
52609-0001_4d497c0f-ca50-490c-8722-65d3a234a299 52609-0001 HUMAN PRESCRIPTI
ON DRUG ALKERAN melphalan "TABLET, FILM COATED" ORAL 20110101
NDA NDA014691 "Apo-Pharma USA, Inc" MELPHALAN 2 mg/1
"Alkylating Activity [MoA],Alkylating Drug [EPC]"
52609-3001_f4a5c454-0c4e-4753-a0dc-83c06281e217 52609-3001 HUMAN PRESCRIPTI
ON DRUG ALKERAN melphalan hydrochloride KIT 20110101
NDA NDA020207 "Apo-Pharma USA, Inc"
52609-0006_af4b6a41-0983-bb51-dfa2-1855923d61d4 52609-0006 HUMAN PRESCRIPTI
ON DRUG FERRIPROX deferiprone "TABLET, FILM COATED" ORAL
20111125 NDA NDA021825 "ApoPharma USA, Inc." DEFERIPR
ONE 500 mg/1 "Iron Chelating Activity [MoA],Iron Chelator [EPC]"
60505-0025_4501ec41-0a9f-b4bf-43cb-40916ce796bf 60505-0025 HUMAN PRESCRIPTI
ON DRUG Ranitidine ranitidine hydrochloride "TABLET, FILM CO
ATED" ORAL 19970913 ANDA ANDA074680 Apotex Corp
60505-0026_4501ec41-0a9f-b4bf-43cb-40916ce796bf 60505-0026 HUMAN PRESCRIPTI
ON DRUG Ranitidine ranitidine hydrochloride "TABLET, FILM CO
60505-0065_6858f7ae-8277-7dde-2f5a-1c426b942782 60505-0065 HUMAN PRESCRIPTI
ORAL 20031111 ANDA ANDA076048 Apotex Corp OMEPRAZO
LE 20 mg/1 "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA
],Cytochrome P450 2C19 Inhibitors [MoA]"
60505-0135_26427b94-217b-9e3e-aaea-afa54f1bfe0d 60505-0135 HUMAN PRESCRIPTI
ON DRUG Diclofenac Potassium Diclofenac Potassium "TABLET, FILM CO
DICLOFENAC POTASSIUM 50 mg/1 "Cyclooxygenase Inhibitors [MoA],Decreas
ed Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemi
60505-0157_0b85149b-2210-7186-c1a4-669678abafc8 60505-0157 HUMAN PRESCRIPTI
BUPROPION HYDROCHLORIDE 100 mg/1 "Aminoketone [EPC],Dopamine Uptake Inhib
itors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [
PE],Norepinephrine Uptake Inhibitors [MoA]"
60505-0158_0b85149b-2210-7186-c1a4-669678abafc8 60505-0158 HUMAN PRESCRIPTI
BUPROPION HYDROCHLORIDE 75 mg/1 "Aminoketone [EPC],Dopamine Uptake Inhib
itors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [
PE],Norepinephrine Uptake Inhibitors [MoA]"
60505-0164_c66a300d-a607-280b-1a0f-eecdc18dce72 60505-0164 HUMAN PRESCRIPTI
ON DRUG Fluvoxamine Maleate Fluvoxamine Maleate TABLET ORAL
20010710 ANDA ANDA075902 Apotex Corp FLUVOXAMINE MALE
ATE 25 mg/1 "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inh
ibitors [MoA]"
ibitors [MoA]"
ibitors [MoA]"
60505-0180_f19bb894-c767-21f7-431f-57d5dfc65bc9 60505-0180 HUMAN PRESCRIPTI
Apotex Corp SERTRALINE HYDROCHLORIDE 25 mg/1 "Serotonin Reupt
60505-0265_4bd910c6-9db6-985a-33a0-6e17eba171ff 60505-0265 HUMAN PRESCRIPTI
Apotex Corp BENAZEPRIL HYDROCHLORIDE 5 mg/1 "Angiotensin Con
60505-0381_55936b58-8d5d-6e20-4e76-c1c3b0737785 60505-0381 HUMAN PRESCRIPTI
ON DRUG Ondansetron ondansetron hydrochloride SOLUTION
ORAL 20080313 ANDA ANDA078127 Apotex Corp ONDANSET
RON HYDROCHLORIDE 4 mg/5mL "Serotonin 3 Receptor Antagonists [MoA],
60505-0402_b06b2299-84a6-c7f8-7ec2-c89c3b359892 60505-0402 HUMAN PRESCRIPTI
ON DRUG PAXIL paroxetine hydrochloride SUSPENSION ORAL
20110101 NDA NDA020710 Apotex Corp PAROXETINE HYDRO
CHLORIDE HEMIHYDRATE 10 mg/5mL "Serotonin Reuptake Inhibitor [EPC],Sero
60505-0748_6d2fe6ec-eb91-49d3-893e-796f83656ac0 60505-0748 HUMAN PRESCRIPTI
ON DRUG Cefazolin Cefazolin "INJECTION, POWDER, FOR SOLUTION
26 Apotex Corp CEFAZOLIN SODIUM 500 mg/1 "Cephalosporin A
ntibacterial [EPC],Cephalosporins [Chemical/Ingredient]"
26 Apotex Corp CEFAZOLIN SODIUM 1 g/1 "Cephalosporin A
60505-0769_253af1f8-6a2f-4f81-bb9b-56dde756afe4 60505-0769 HUMAN PRESCRIPTI
" INTRAVENOUS 20060613 ANDA ANDA065247 Apotex C
orp CEFAZOLIN SODIUM 10 g/1 "Cephalosporin Antibacterial [EP
C],Cephalosporins [Chemical/Ingredient]"
60505-1308_86b20dfa-287d-b8c7-dd32-4e5c607caef0 60505-1308 HUMAN PRESCRIPTI
CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 "Quinolone Antimicrobial [EPC],Q
60505-1320_da7b8522-674f-6a8e-397d-4aa77da100f3 60505-1320 HUMAN PRESCRIPTI
ON DRUG Midodrine Hydrochloride midodrine hydrochloride TABLET ORAL
20060912 ANDA ANDA077746 Apotex Corp MIDODRINE HYDROC
HLORIDE 2.5 mg/1 "Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonis
t [EPC]"
HLORIDE 5 mg/1 "Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonis
t [EPC]"
t [EPC]"
60505-2504_5f11e599-552d-6094-320b-bce90e234a52 60505-2504 HUMAN PRESCRIPTI
ON DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL
20041129 ANDA ANDA076795 Apotex Corp LITHIUM CARBONAT
E 300 mg/1 Mood Stabilizer [EPC]
60505-2532_2a094b16-3416-f9a3-1935-0c6361c4ae57 60505-2532 HUMAN PRESCRIPTI
ON DRUG Cefprozil Cefprozil "TABLET, FILM COATED" ORAL
20080509 ANDA ANDA065327 Apotex Corp CEFPROZIL
250 mg/1
60505-2533_2a094b16-3416-f9a3-1935-0c6361c4ae57 60505-2533 HUMAN PRESCRIPTI
20080509 ANDA ANDA065327 Apotex Corp CEFPROZIL
500 mg/1
60505-2584_145e2cd1-e5d3-d27a-3d6c-a8d531caa37b 60505-2584 HUMAN PRESCRIPTI
ANDA ANDA077953 Apotex Corp RISPERIDONE 0.25 mg/1 Atypical
Antipsychotic [EPC]
ANDA ANDA077953 Apotex Corp RISPERIDONE 0.5 mg/1 Atypical
Antipsychotic [EPC]
ANDA ANDA077953 Apotex Corp RISPERIDONE 1 mg/1 Atypical
Antipsychotic [EPC]
Antipsychotic [EPC]
Antipsychotic [EPC]
Antipsychotic [EPC]
60505-2615_b64c31ed-fc97-4d38-edaf-22f123d82f23 60505-2615 HUMAN PRESCRIPTI
20070913 ANDA ANDA065384 Apotex Corp CLARITHROMYCIN
500 mg/1 "Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],
60505-2616_b64c31ed-fc97-4d38-edaf-22f123d82f23 60505-2616 HUMAN PRESCRIPTI
20070913 ANDA ANDA065384 Apotex Corp CLARITHROMYCIN
250 mg/1 "Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],
60505-2634_863b9832-c2b6-f0ce-6f93-fef40fa756a2 60505-2634 HUMAN PRESCRIPTI
ORAL 20081112 ANDA ANDA078449 Apotex Corp ALPRAZOL
nt]" CIV
nt]" CIV
nt]" CIV
nt]" CIV
60505-2651_fa28891f-11ab-179b-e2d1-f9afab3ac4f1 60505-2651 HUMAN PRESCRIPTI
ON DRUG Eplerenone Eplerenone TABLET ORAL 20080730
ANDA ANDA078482 Apotex Corp EPLERENONE 25 mg/1 "Aldoste
rone Antagonist [EPC],Aldosterone Antagonists [MoA]"
60505-2652_fa28891f-11ab-179b-e2d1-f9afab3ac4f1 60505-2652 HUMAN PRESCRIPTI
ON DRUG Eplerenone Eplerenone TABLET ORAL 20080730
ANDA ANDA078482 Apotex Corp EPLERENONE 50 mg/1 "Aldoste
rone Antagonist [EPC],Aldosterone Antagonists [MoA]"
60505-2653_3f95cf97-2c6e-b600-c438-abc541609e88 60505-2653 HUMAN PRESCRIPTI
20081117 ANDA ANDA071258 Apotex Corp TRAZODONE HYDROC
HLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC]
60505-2658_8f2bb168-9c39-2dd5-3375-a4f300bb5b67 60505-2658 HUMAN PRESCRIPTI
ON DRUG Amiodarone Hydrochloride Amiodarone Hydrochloride
TABLET ORAL 20081106 ANDA ANDA078578 APOTEX Corp
AMIODARONE HYDROCHLORIDE 200 mg/1 "Antiarrhythmic [EPC],Cytochrome
P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 I
nhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibit
ors [MoA]"
60505-2663_0a9c5e7b-1db5-a708-78a1-f1bc7fc00834 60505-2663 HUMAN PRESCRIPTI
ANDA ANDA078625 Apotex Corp LAMOTRIGINE 25 mg/1 "Anti-ep
60505-2760_ef9d6bea-dc44-07ae-9d38-115ebee762cc 60505-2760 HUMAN PRESCRIPTI
20090327 ANDA ANDA077733 Apotex Corp TOPIRAMATE
60505-2795_eb64eea6-c2ec-c183-3ebb-29d35b70c390 60505-2795 HUMAN PRESCRIPTI
ON DRUG IBANDRONATE SODIUM IBANDRONATE SODIUM "TABLET, FILM CO
IBANDRONATE SODIUM 150 mg/1 "Bisphosphonate [EPC],Diphosphonates [Ch
emical/Ingredient]"
60505-2965_09b0f599-3deb-fd06-11a4-34c6dfcd7508 60505-2965 HUMAN PRESCRIPTI
ON DRUG Mycophenolic Acid Mycophenolic Acid "TABLET, DELAYED
RELEASE" ORAL 20120821 ANDA ANDA091558 Apotex C
orp MYCOPHENOLATE SODIUM 180 mg/1 Antimetabolite Immunosuppressant
[EPC]
60505-2967_00e70f0e-ee2b-2b68-83b3-bda00be98283 60505-2967 HUMAN PRESCRIPTI
ON DRUG Mycophenolate Mofetil Mycophenolate Mofetil "TABLET, COATED"
ORAL 20090504 ANDA ANDA090499 Apotex Corp MYCOPHEN
60505-2968_00e70f0e-ee2b-2b68-83b3-bda00be98283 60505-2968 HUMAN PRESCRIPTI
20090504 ANDA ANDA090419 Apotex Corp MYCOPHENOLATE MO
FETIL 250 mg/1 Antimetabolite Immunosuppressant [EPC]
60505-3160_9b410cdf-0a09-6ab4-91eb-5ab51a3d9bf0 60505-3160 HUMAN PRESCRIPTI
ON DRUG Losartan Potassium Losartan Potassium "TABLET, FILM CO
LOSARTAN POTASSIUM 25 mg/1 "Angiotensin 2 Receptor Antagonists [MoA
60505-3285_f02b47a7-bb71-9987-8d2c-49026f6956c7 60505-3285 HUMAN PRESCRIPTI
ON DRUG RILUZOLE RILUZOLE "TABLET, FILM COATED" ORAL
20130618 ANDA ANDA091300 Apotex Corp RILUZOLE
50 mg/1 "Benzothiazole [EPC],Benzothiazoles [Chemical/Ingredient]"
60505-3409_bdb49a77-d769-248d-fdb3-90d38b2f0531 60505-3409 HUMAN PRESCRIPTI
ON DRUG Quinapril Hydrochloride and Hydrochlorothiazide Quinapril Hydroc
hloride and Hydrochlorothiazide "TABLET, FILM COATED" ORAL 20130312
ANDA ANDA091524 Apotex Corp HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLO
RIDE 12.5; 10 mg/1; mg/1 "Angiotensin Converting Enzyme Inhibitor
[EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Th
iazide Diuretic [EPC],Thiazides [Chemical/Ingredient]"
RIDE 12.5; 20 mg/1; mg/1 "Angiotensin Converting Enzyme Inhibitor
RIDE 25; 20 mg/1; mg/1 "Angiotensin Converting Enzyme Inhibitor [EPC],A
60505-3562_29b0cb8d-e21a-5b11-0d7d-1750fc84eb17 60505-3562 HUMAN PRESCRIPTI
MONTELUKAST SODIUM 10 mg/1 "Leukotriene Receptor Antagonist [EPC],L
eukotriene Receptor Antagonists [MoA]"
E" ORAL 20120803 ANDA ANDA201508 Apotex Corp
E" ORAL 20120803 ANDA ANDA201508 Apotex Corp
60505-3578_c3895624-6196-1b2c-1230-fbf8f03226d6 60505-3578 HUMAN PRESCRIPTI
ON DRUG Meloxicam Meloxicam TABLET ORAL 20100514
ANDA ANDA077928 Apotex Corp MELOXICAM 7.5 mg/1 "Cycloox
60505-3579_c3895624-6196-1b2c-1230-fbf8f03226d6 60505-3579 HUMAN PRESCRIPTI
ANDA ANDA077928 Apotex Corp MELOXICAM 15 mg/1 "Cycloox
60505-3583_72fdf672-e58a-0cb6-53a1-c46ef18f1c45 60505-3583 HUMAN PRESCRIPTI
ON DRUG Abacavir Sulfate Abacavir Sulfate "TABLET, FILM CO
ABACAVIR SULFATE 300 mg/1 "Human Immunodeficiency Virus Nucleoside
60505-3618_432f7675-1f8c-906d-ceb3-a15c9ccb460c 60505-3618 HUMAN PRESCRIPTI
ON DRUG Candesartan Cilexetil Candesartan cilexetil TABLET ORAL
20140113 ANDA ANDA202079 Apotex Corp CANDESARTAN CILE
XETIL 4 mg/1 "Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2
ON DRUG Candesartan Cilexetil Candesartan Cilexetil TABLET ORAL
ON DRUG PAXIL paroxetine hydrochloride "TABLET, FILM COATED"
ORAL 20110101 NDA NDA020031 Apotex Corp PAROXETI
NE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 "Serotonin Reuptake Inhibitor [E
60505-3668_cf9d7915-97a7-dfc9-a11c-e941e09b1837 60505-3668 HUMAN PRESCRIPTI
ON DRUG PAXIL CR paroxetine hydrochloride "TABLET, FILM COATED, EX
TENDED RELEASE" ORAL 20110101 NDA NDA020936 Apotex C
orp PAROXETINE HYDROCHLORIDE HEMIHYDRATE 12.5 mg/1 "Serotonin Reupt
orp PAROXETINE HYDROCHLORIDE HEMIHYDRATE 25 mg/1 "Serotonin Reupt
orp PAROXETINE HYDROCHLORIDE HEMIHYDRATE 37.5 mg/1 "Serotonin Reupt
60505-3673_8ef51a3b-8d22-4171-acb2-0294b6a27bc3 60505-3673 HUMAN PRESCRIPTI
ON DRUG PAROXETINE HYDROCHLORIDE paroxetine hydrochloride
"TABLET, FILM COATED, EXTENDED RELEASE" ORAL 20100913 NDA
NDA020936 Apotex Corp PAROXETINE HYDROCHLORIDE HEMIHYDRATE 12.5
mg/1 "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]"
NDA020936 Apotex Corp PAROXETINE HYDROCHLORIDE HEMIHYDRATE 25
NDA020936 Apotex Corp PAROXETINE HYDROCHLORIDE HEMIHYDRATE 37.5
60505-3693_95f50fbe-3819-fe56-6cdf-41c28e7be011 60505-3693 HUMAN PRESCRIPTI
ON DRUG Zolmitriptan Zolmitriptan "TABLET, FILM COATED" ORAL
20130514 ANDA ANDA202078 Apotex Corp ZOLMITRIPTAN
2.5 mg/1 "Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agon
ists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]"
ON DRUG Zolmitriptan Zolmitriptan "TABLET, FILM COATED" ORAL
20130514 ANDA ANDA202078 Apotex Corp ZOLMITRIPTAN
5 mg/1 "Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agon
60505-3698_6edd692d-f695-3b93-1661-5046bf2636d4 60505-3698 HUMAN PRESCRIPTI
ON DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET ORAL
20121229 ANDA ANDA202244 Apotex Corp RIZATRIPTAN BENZ
OATE 5 mg/1 "Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Recep
tor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]"
60505-3699_6edd692d-f695-3b93-1661-5046bf2636d4 60505-3699 HUMAN PRESCRIPTI
20121229 ANDA ANDA202244 Apotex Corp RIZATRIPTAN BENZ
OATE 10 mg/1 "Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Recep
ON DRUG Zolmitriptan Zolmitriptan "TABLET, ORALLY DISINTEGRATING"
ORAL 20130514 ANDA ANDA202476 Apotex Corp ZOLMITRI
PTAN 2.5 mg/1 "Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Recep
ON DRUG Zolmitriptan Zolmitriptan "TABLET, ORALLY DISINTEGRATING"
ORAL 20130514 ANDA ANDA202476 Apotex Corp ZOLMITRI
PTAN 5 mg/1 "Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Recep
60505-3723_f80652f3-cc59-40cd-5073-bfc083934c8a 60505-3723 HUMAN PRESCRIPTI
ON DRUG Rizatriptan Benzoate Rizatriptan Benzoate "TABLET, ORALLY
DISINTEGRATING" ORAL 20130701 ANDA ANDA202477 Apotex C
orp RIZATRIPTAN BENZOATE 5 mg/1 "Serotonin 1b Receptor Agonists
r Agonist [EPC]"
60505-3724_f80652f3-cc59-40cd-5073-bfc083934c8a 60505-3724 HUMAN PRESCRIPTI
DISINTEGRATING" ORAL 20130701 ANDA ANDA202477 Apotex C
orp RIZATRIPTAN BENZOATE 10 mg/1 "Serotonin 1b Receptor Agonists
r Agonist [EPC]"
60505-3788_4143ae49-f8ca-0482-2ee1-ccd86a3590a5 60505-3788 HUMAN PRESCRIPTI
ANDA ANDA203021 Apotex Corp NEVIRAPINE 200 mg/1 "Human I
mmunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [E
PC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcrip
tase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Indu
cers [MoA]"
60505-4058_6309c01e-9dac-2896-b90d-1b1837f3d3a7 60505-4058 HUMAN PRESCRIPTI
ON DRUG Nevirapine Nevirapine "TABLET, EXTENDED RELEASE"
ORAL 20140415 ANDA ANDA205258 Apotex Corp NEVIRAPI
NE 400 mg/1 "Human Immunodeficiency Virus 1 Non-Nucleoside Analog Re
verse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],
Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducer
s [MoA],Cytochrome P450 2B6 Inducers [MoA]"
26 Apotex Corp CEFAZOLIN SODIUM 1 g/1 "Cephalosporin A
60505-6094_253af1f8-6a2f-4f81-bb9b-56dde756afe4 60505-6094 HUMAN PRESCRIPTI
orp CEFAZOLIN SODIUM 10 g/1 "Cephalosporin Antibacterial [EP
60505-6110_4d511336-3f94-4694-8f8b-088cb3bdcda0 60505-6110 HUMAN PRESCRIPTI
E" INTRAVENOUS 20130920 ANDA ANDA202930 Apotex C
orp ZOLEDRONIC ACID 4 mg/5mL "Bisphosphonate [EPC],Diphosphonates [Ch
emical/Ingredient]"
60505-0003_5d8a3272-ca8b-4fea-6abd-50d0b8be8f3d 60505-0003 HUMAN PRESCRIPTI
ON DRUG Captopril Captopril TABLET ORAL 20051207
ANDA ANDA074737 Apotex Corp. CAPTOPRIL 12.5 mg/1 "Angiote
[MoA]"
ANDA ANDA074737 Apotex Corp. CAPTOPRIL 25 mg/1 "Angiote
[MoA]"
[MoA]"
[MoA]"
60505-0007_b4853ad8-f70d-cb67-deea-1135f6e7f0e8 60505-0007 HUMAN PRESCRIPTI
ON DRUG DILT-CD diltiazem hydrochloride CAPSULE ORAL 20060830
ANDA ANDA076151 Apotex Corp. DILTIAZEM HYDROCHLORIDE 120 mg/1
"Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]"
60505-0014_adf5ffa1-f1ea-060a-1e97-044cf833394e 60505-0014 HUMAN PRESCRIPTI
ON DRUG DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE "CAPSULE, EXTEND
ED RELEASE" ORAL 20010730 ANDA ANDA074943 Apotex C
orp. DILTIAZEM HYDROCHLORIDE 120 mg/1 "Calcium Channel Antagonists [Mo
A],Calcium Channel Blocker [EPC]"
60505-0027_f7cb5bce-0085-e704-8cfb-74f1f69777b2 60505-0027 HUMAN PRESCRIPTI
ON DRUG Ticlopidine hydrochloride Ticlopidine hydrochloride
Apotex Corp. TICLOPIDINE HYDROCHLORIDE 250 mg/1 "Decreased Plate
let Aggregation [PE],Platelet Aggregation Inhibitor [EPC]"
60505-0033_4bb2cded-8a0d-e8d6-1d25-e8dbee54ac59 60505-0033 HUMAN PRESCRIPTI
ORAL 19990610 ANDA ANDA075191 Apotex Corp. PENTOXIF
YLLINE 400 mg/1 "Blood Viscosity Reducer [EPC],Hematologic Activity Alte
ration [PE]"
60505-0034_576d0ca4-822d-e17a-4642-c61c097e69f2 60505-0034 HUMAN PRESCRIPTI
19981001 ANDA ANDA075034 Apotex Corp. GEMFIBROZIL
600 mg/1 "Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome
Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingre
dient]"
60505-0039_591918b9-6593-39fb-73dc-2ddace842523 60505-0039 HUMAN PRESCRIPTI
ANDA ANDA075419 Apotex Corp. ETODOLAC 200 mg/1 "Cycloox
60505-0040_591918b9-6593-39fb-73dc-2ddace842523 60505-0040 HUMAN PRESCRIPTI
ANDA ANDA075419 Apotex Corp. ETODOLAC 300 mg/1 "Cycloox
60505-0041_bcf04cf9-42a0-5628-54d5-08a6ba6eed20 60505-0041 HUMAN PRESCRIPTI
20030501 ANDA ANDA076004 Apotex Corp. ETODOLAC
60505-0042_1ed687b5-28d0-a204-088d-bec9cb9b309d 60505-0042 HUMAN PRESCRIPTI
ON DRUG ACYCLOVIR ACYCLOVIR CAPSULE ORAL 20060320
ANDA ANDA075677 Apotex Corp. ACYCLOVIR 200 mg/1 "DNA Pol
ymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase I
nhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [E
PC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Anal
og [Chemical/Ingredient]"
60505-0055_76737f47-6b8b-3297-48c3-282d7acfb1eb 60505-0055 HUMAN PRESCRIPTI
ON DRUG SELEGILINE HYDROCHLORIDE SELEGILINE HYDROCHLORIDE
CAPSULE ORAL 19970715 ANDA ANDA075321 Apotex Corp.
SELEGILINE HYDROCHLORIDE 5 mg/1 "Monoamine Oxidase Inhibitor [EP
C],Monoamine Oxidase Inhibitors [MoA],Monoamine Oxidase Type B Inhibitor [EPC],M
onoamine Oxidase-B Inhibitors [MoA]"
60505-0080_fad9271e-3d34-a358-759d-312d54435b4c 60505-0080 HUMAN PRESCRIPTI
20030201 ANDA ANDA076140 Apotex Corp. SOTALOL HYDROCHL
ORIDE 80 mg/1 Antiarrhythmic [EPC]
60505-0083_825e1590-5b04-bad2-c855-c28a3d04f120 60505-0083 HUMAN PRESCRIPTI
ON DRUG PAROXETINE paroxetine hydrochloride "TABLET, FILM CO
ATED" ORAL 20030908 ANDA ANDA075356 Apotex Corp.
PAROXETINE HYDROCHLORIDE ANHYDROUS 20 mg/1 "Serotonin Reuptake Inhi
60505-0093_e05d83de-d6f3-c70e-4b27-3a9fa9526d32 60505-0093 HUMAN PRESCRIPTI
ON DRUG Doxazosin Doxazosin TABLET ORAL 20110714
ANDA ANDA075580 Apotex Corp. DOXAZOSIN MESYLATE 1 mg/1
60505-0102_bcf04cf9-42a0-5628-54d5-08a6ba6eed20 60505-0102 HUMAN PRESCRIPTI
20030501 ANDA ANDA076004 Apotex Corp. ETODOLAC
60505-0112_1e0c755a-d3f1-671b-9e5d-61234fdf6c94 60505-0112 HUMAN PRESCRIPTI
ANDA ANDA075360 Apotex Corp. GABAPENTIN 100 mg/1 "Anti-ep
ivity [PE]"
ivity [PE]"
ivity [PE]"
60505-0115_121ff962-1f7c-db33-f6e5-f8e539c3d526 60505-0115 HUMAN PRESCRIPTI
ANDA ANDA075498 Apotex Corp. TERAZOSIN HYDROCHLORIDE 1 mg/1
60505-0128_59ad5adc-35ff-2637-19e0-0cabdee6475a 60505-0128 HUMAN PRESCRIPTI
ON DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET ORAL
20081009 ANDA ANDA077120 Apotex Corp. CARBIDOPA; LEVOD
OPA 10; 100 mg/1; mg/1 "Aromatic Amino Acid Decarboxylation Inhibitor [
EPC],DOPA Decarboxylase Inhibitors [MoA],Aromatic Amino Acid Decarboxylation Inh
60505-0131_64972eea-4765-b1aa-fdab-a4d46e45b007 60505-0131 HUMAN PRESCRIPTI
D RELEASE" ORAL 20040616 ANDA ANDA076212 Apotex C
orp. CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 "Aromatic Amino Acid Dec
arboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA]"
60505-0132_64972eea-4765-b1aa-fdab-a4d46e45b007 60505-0132 HUMAN PRESCRIPTI
orp. CARBIDOPA; LEVODOPA 50; 200 mg/1; mg/1 "Aromatic Amino Acid Dec
arboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA]"
60505-0133_a82d1ce4-3c34-ffe8-3349-a53e3a12081e 60505-0133 HUMAN PRESCRIPTI
ON DRUG Cyclosporine Cyclosporine "CAPSULE, LIQUID FILLED"
ORAL 20020529 ANDA ANDA065040 Apotex Corp. CYCLOSPO
RINE 25 mg/1 "Calcineurin Inhibitor Immunosuppressant [EPC],Calcineur
rs [MoA]"
60505-0134_a82d1ce4-3c34-ffe8-3349-a53e3a12081e 60505-0134 HUMAN PRESCRIPTI
ON DRUG Cyclosporine Cyclosporine "CAPSULE, LIQUID FILLED"
ORAL 20020529 ANDA ANDA065040 Apotex Corp. CYCLOSPO
RINE 100 mg/1 "Calcineurin Inhibitor Immunosuppressant [EPC],Calcineur
rs [MoA]"
60505-0141_ff50cc7e-c33d-a0b3-a857-d7f422486ca6 60505-0141 HUMAN PRESCRIPTI
ANDA ANDA075795 Apotex Corp. GLIPIZIDE 5 mg/1 "Sulfony
lurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient]"
60505-0142_ff50cc7e-c33d-a0b3-a857-d7f422486ca6 60505-0142 HUMAN PRESCRIPTI
ANDA ANDA075795 Apotex Corp. GLIPIZIDE 10 mg/1 "Sulfony
lurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient]"
60505-0147_b91700ac-cb4f-f19d-53ad-505fa5634309 60505-0147 HUMAN OTC DRUG
ANDA ANDA076471 Apotex Corp. LORATADINE 10 mg/1
60505-0168_2ad4c6a8-9113-7871-413f-411585a95aca 60505-0168 HUMAN PRESCRIPTI
20110718 ANDA ANDA076341 Apotex Corp. PRAVASTATIN SODI
UM 10 mg/1 "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl
60505-0171_8b6db104-528b-016b-46bf-6cbf48e37c14 60505-0171 HUMAN PRESCRIPTI
ON DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE "TABLET, COATED"
ORAL 20020710 ANDA ANDA075981 Apotex Corp. TRAMADOL
HYDROCHLORIDE 50 mg/1 "Full Opioid Agonists [MoA],Opioid Agonist [EPC]
"
60505-0176_e23b8684-5fcd-658d-459d-e4e1e34ccb4a 60505-0176 HUMAN PRESCRIPTI
ON DRUG oxaprozin oxaprozin "TABLET, FILM COATED" ORAL
20040903 ANDA ANDA075987 Apotex Corp. OXAPROZIN
60505-0183_f8b4576c-3ca2-97cc-34e6-db4cdbecab31 60505-0183 HUMAN PRESCRIPTI
ON DRUG CARBAMAZEPINE CARBAMAZEPINE TABLET ORAL 20020901
ANDA ANDA075948 Apotex Corp. CARBAMAZEPINE 200 mg/1 "Anti-ep
ivity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA]"
60505-0184_3e5ce79a-c894-81cf-76e6-f5007ea4befa 60505-0184 HUMAN PRESCRIPTI
ON DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20080626
ANDA ANDA076102 Apotex Corp. LISINOPRIL 2.5 mg/1 "Angiote
[MoA]"
ANDA ANDA076102 Apotex Corp. LISINOPRIL 5 mg/1 "Angiote
[MoA]"
[MoA]"
[MoA]"
[MoA]"
[MoA]"
60505-0190_19c3ceb3-f5d8-4480-bec4-7500411a047e 60505-0190 HUMAN PRESCRIPTI
gredient]"
gredient]"
gredient]"
60505-0193_63959fdd-dd47-8779-8404-c5eb48b03ff9 60505-0193 HUMAN PRESCRIPTI
20070524 ANDA ANDA076719 Apotex Corp. AMLODIPINE BESYL
ATE 2.5 mg/1 "Calcium Channel Antagonists [MoA],Dihydropyridine Calci
ATE 5 mg/1 "Calcium Channel Antagonists [MoA],Dihydropyridine Calci
ATE 10 mg/1 "Calcium Channel Antagonists [MoA],Dihydropyridine Calci
60505-0205_fe6f1b68-41bd-df79-4873-af505ded2e02 60505-0205 HUMAN PRESCRIPTI
Apotex Corp. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1
ibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemica
l/Ingredient]"
Apotex Corp. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1
l/Ingredient]"
Apotex Corp. HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 "Angiote
[MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingred
ient]"
60505-0208_fb11d0ea-f840-2d73-92ae-bfea5544fbde 60505-0208 HUMAN PRESCRIPTI
ON DRUG Enalapril Maleate and Hydrochlorothiazide Enalapril maleat
e and hydrochlorothiazide TABLET ORAL 20070619 ANDA
ANDA076486 Apotex Corp. ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE 5; 12.5
mg/1; mg/1 "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-conve
rting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [
PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient]"
60505-0209_fb11d0ea-f840-2d73-92ae-bfea5544fbde 60505-0209 HUMAN PRESCRIPTI
ON DRUG Enalapril Maleate and Hydrochlorothiazide Enalapril maleat
e and hydrochlorothiazide TABLET ORAL 20070619 ANDA
ANDA076486 Apotex Corp. ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE 10; 25
60505-0210_c7358515-6ae6-8f89-6958-72dd9786d5cb 60505-0210 HUMAN PRESCRIPTI
ON DRUG DILTZAC Diltiazem Hydrochloride "CAPSULE, EXTENDED RELEASE"
ORAL 20090203 ANDA ANDA076395 Apotex Corp. DILTIAZE
M HYDROCHLORIDE 120 mg/1 "Calcium Channel Antagonists [MoA],Calcium Chann
el Blocker [EPC]"
el Blocker [EPC]"
el Blocker [EPC]"
el Blocker [EPC]"
el Blocker [EPC]"
60505-0222_0a632e54-1125-6600-1b7a-da9c83853440 60505-0222 HUMAN PRESCRIPTI
60505-0232_1decd030-d17c-71b3-d349-09faa0a56646 60505-0232 HUMAN PRESCRIPTI
ANDA ANDA076894 Apotex Corp. TORSEMIDE 5 mg/1 "Increas
ed Diuresis at Loop of Henle [PE],Loop Diuretic [EPC]"
60505-0247_7826636a-642f-38d9-0394-6e789f49dba7 60505-0247 HUMAN PRESCRIPTI
20070822 ANDA ANDA077666 Apotex Corp. MIRTAZAPINE
15 mg/1
30 mg/1
45 mg/1
60505-0251_64087f97-084b-61d8-34cb-2f5a599b6fa3 60505-0251 HUMAN PRESCRIPTI
ON DRUG tizanidine tizanidine TABLET ORAL 20040116
ANDA ANDA076533 Apotex Corp. TIZANIDINE HYDROCHLORIDE 2
mg/1 "Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EP
C]"
60505-0252_64087f97-084b-61d8-34cb-2f5a599b6fa3 60505-0252 HUMAN PRESCRIPTI
ON DRUG tizanidine tizanidine TABLET ORAL 20040116
ANDA ANDA076533 Apotex Corp. TIZANIDINE HYDROCHLORIDE 4
mg/1 "Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EP
C]"
60505-0253_65ea3322-6688-acce-9200-ecc1199f1477 60505-0253 HUMAN PRESCRIPTI
ORAL 20120517 ANDA ANDA076274 Apotex Corp. CLOPIDOG
60505-0257_59ba7fff-787d-4ba7-4078-b335868ed697 60505-0257 HUMAN PRESCRIPTI
ON DRUG Desmopressin Acetate desmopressin acetate TABLET ORAL
20060307 ANDA ANDA077414 Apotex Corp. DESMOPRESSIN ACE
TATE 0.1 mg/1 "Factor VIII Activator [EPC],Increased Coagulation Facto
r VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopr
essin Analog [EPC],Vasopressins [Chemical/Ingredient]"
60505-0258_59ba7fff-787d-4ba7-4078-b335868ed697 60505-0258 HUMAN PRESCRIPTI
ON DRUG Desmopressin Acetate desmopressin acetate TABLET ORAL
TATE 0.2 mg/1 "Factor VIII Activator [EPC],Increased Coagulation Facto
orp. METFORMIN HYDROCHLORIDE 500 mg/1 "Biguanide [EPC],Biguanides [Che
mical/Ingredient]"
60505-0271_2e7de2ba-031e-5d77-ef87-a2503c5934d0 60505-0271 HUMAN PRESCRIPTI
ON DRUG Moexipril Hydrochloride Moexipril Hydrochloride TABLET ORAL
20080609 ANDA ANDA078454 Apotex Corp. MOEXIPRIL HYDROC
HLORIDE 7.5 mg/1 "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotens
60505-0272_2e7de2ba-031e-5d77-ef87-a2503c5934d0 60505-0272 HUMAN PRESCRIPTI
ON DRUG Moexipril Hydrochloride Moexipril Hydrochloride TABLET ORAL
20080609 ANDA ANDA078454 Apotex Corp. MOEXIPRIL HYDROC
HLORIDE 15 mg/1 "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotens
60505-0363_7bc4742b-6f34-2c2d-95b9-d70f8358e55f 60505-0363 HUMAN PRESCRIPTI
ON DRUG Ofloxacin Otic Ofloxacin SOLUTION AURICULAR (OTIC)
20040514 ANDA ANDA076527 Apotex Corp. OFLOXACIN
60505-0380_40648939-c609-2ccd-cb80-b98f47e3364f 60505-0380 HUMAN PRESCRIPTI
ANDA ANDA077719 Apotex Corp. RISPERIDONE 1 mg/mL Atypical
Antipsychotic [EPC]
60505-0399_830560a1-630a-beda-04a8-e770a6e461bd 60505-0399 HUMAN PRESCRIPTI
ON DRUG Diclofenac Sodium Diclofenac Sodium SOLUTION
TOPICAL 20140528 ANDA ANDA202027 Apotex Corp. DICLOFEN
AC SODIUM 16.05 mg/mL "Cyclooxygenase Inhibitors [MoA],Decreased Prost
aglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingr
60505-0501_885c8419-6bf4-96b4-4bcb-67f7f6446218 60505-0501 HUMAN PRESCRIPTI
ON DRUG Imiquimod imiquimod CREAM TOPICAL 20120914
ANDA ANDA091308 Apotex Corp. IMIQUIMOD 50 mg/1000mg
"Increased Cytokine Activity [PE],Increased Cytokine Production [PE],Interferon
Inducers [MoA]"
60505-0560_4ebe9909-6509-ab0a-931c-e70bd210125f 60505-0560 HUMAN PRESCRIPTI
ON DRUG Ofloxacin Ophthalmic ofloxacin SOLUTION OPHTHALM
IC 20040514 ANDA ANDA076513 Apotex Corp. OFLOXACI
N 3 mg/mL "Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingr
edient]"
60505-0562_261a59a6-2e07-0fc8-2566-434735234432 60505-0562 HUMAN PRESCRIPTI
ON DRUG Lactulose Lactulose SOLUTION ORAL; RECTAL
20050126 ANDA ANDA076645 Apotex Corp. LACTULOSE
10 g/15mL "Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activi
ty [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"
60505-0565_55eddb0c-25d2-7825-5f6c-0e8bd671ca1e 60505-0565 HUMAN PRESCRIPTI
ON DRUG Latanoprost Latanoprost SOLUTION OPHTHALMIC
20110322 ANDA ANDA077697 Apotex Corp. LATANOPROST
50 ug/mL "Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient]
"
60505-0570_8e296920-686c-ec04-a044-632974bbbc80 60505-0570 HUMAN PRESCRIPTI
ON DRUG Ketorolac Tromethamine ketorolac tromethamine SOLUTION
OPHTHALMIC 20091207 ANDA ANDA077308 Apotex Corp.
matory Drug [EPC]"
60505-0578_da5f9289-b3c9-ff97-4c98-7967866fd0e6 60505-0578 HUMAN PRESCRIPTI
ON DRUG AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE
SOLUTION/ DROPS INTRAOCULAR 20091201 ANDA ANDA078621
Apotex Corp. AZELASTINE HYDROCHLORIDE 0.5 mg/mL "Histamine H1 Re
60505-0584_eed9aa31-2d42-7087-271c-b6aff283d09b 60505-0584 HUMAN PRESCRIPTI
ON DRUG Epinastine Hydrochloride Epinastine Hydrochloride
SOLUTION OPHTHALMIC 20111031 ANDA ANDA090919
Apotex Corp. EPINASTINE HYDROCHLORIDE 0.5 mg/mL "Adrenergic Agon
ists [MoA],Adrenergic Receptor Agonist [EPC],Decreased Histamine Release [PE],Hi
stamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC]"
60505-0597_45c57114-5f79-4d70-9423-7b87fb554971 60505-0597 HUMAN PRESCRIPTI
20110715 ANDA ANDA077259 Apotex Corp. TIMOLOL MALEATE
2.5 mg/mL
60505-0598_45c57114-5f79-4d70-9423-7b87fb554971 60505-0598 HUMAN PRESCRIPTI
20110715 ANDA ANDA077259 Apotex Corp. TIMOLOL MALEATE
5 mg/mL
60505-0813_fd1083f2-df15-141b-1d53-42a2f39ef317 60505-0813 HUMAN PRESCRIPTI
ON DRUG Butorphanol Tartrate Butorphanol Tartrate SOLUTION
NASAL 20021204 ANDA ANDA075499 Apotex Corp. BUTORPHA
NOL TARTRATE 10 mg/mL "Competitive Opioid Antagonists [MoA],Opioid Ago
nist/Antagonist [EPC],Partial Opioid Agonists [MoA]" CIV
60505-0815_02785654-305c-82ab-08db-8ce8b0e42440 60505-0815 HUMAN PRESCRIPTI
ON DRUG DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE SPRAY NASAL
TATE 10 ug/1 "Factor VIII Activator [EPC],Increased Coagulation Facto
60505-0820_9db90eb8-7c60-e73a-a8e2-12d304550c45 60505-0820 HUMAN PRESCRIPTI
ON DRUG BUDESONIDE BUDESONIDE SUSPENSION RESPIRATORY (INH
ALATION) 20090330 ANDA ANDA078202 Apotex Corp.
BUDESONIDE 0.25 mg/2mL "Corticosteroid [EPC],Corticosteroid Hormone Rec
60505-0821_9db90eb8-7c60-e73a-a8e2-12d304550c45 60505-0821 HUMAN PRESCRIPTI
ON DRUG BUDESONIDE BUDESONIDE SUSPENSION RESPIRATORY (INH
ALATION) 20090330 ANDA ANDA078202 Apotex Corp.
BUDESONIDE 0.5 mg/2mL "Corticosteroid [EPC],Corticosteroid Hormone Rec
60505-0823_e58fec42-886d-7ebf-ab42-48a5a4a31a30 60505-0823 HUMAN PRESCRIPTI
ON DRUG CALCITONIN SALMON CALCITONIN SALMON "SPRAY, METERED"
NASAL 20081209 ANDA ANDA076396 Apotex Corp. CALCITON
IN SALMON 200 [iU]/1 "Calcitonin [Chemical/Ingredient],Calcitonin [EP
C]"
60505-0829_34f3376d-16fa-e5a9-fcc2-1a74bf9fb289 60505-0829 HUMAN PRESCRIPTI
ON DRUG Fluticasone Propionate Fluticasone Propionate "SPRAY, METERED"
NASAL 20070919 ANDA ANDA077538 Apotex Corp. FLUTICAS
ONE PROPIONATE 50 ug/1 "Corticosteroid [EPC],Corticosteroid Hormone Rec
60505-0833_5396e6ff-7f50-9762-d952-5b7e76df5f2f 60505-0833 HUMAN PRESCRIPTI
ON DRUG Azelastine Hydrochloride azelastine hydrochloride
"SPRAY, METERED" NASAL 20100301 ANDA ANDA077954
Apotex Corp. AZELASTINE HYDROCHLORIDE 137 ug/1 "Histamine H1 Re
60505-0839_d98ba7b4-65f6-e280-4081-9da5398f8fb5 60505-0839 HUMAN PRESCRIPTI
ON DRUG Budesonide Nasal Budesonide "SPRAY, METERED"
NASAL 20140512 ANDA ANDA078949 Apotex Corp. BUDESONI
DE 32 ug/1 "Corticosteroid [EPC],Corticosteroid Hormone Receptor Ag
onists [MoA]"
60505-0847_47744897-88e2-d6a8-766d-904a5be5c6da 60505-0847 HUMAN PRESCRIPTI
ON DRUG Fluticasone Propionate fluticasone propionate "SPRAY, METERED"
NASAL 20091209 ANDA ANDA077538 Apotex Corp. FLUTICAS
ONE PROPIONATE 50 ug/1 "Corticosteroid [EPC],Corticosteroid Hormone Rec
60505-0848_bb4d282f-234c-9ee0-f229-ebcbb08f0c7b 60505-0848 HUMAN PRESCRIPTI
ON DRUG Azelastine Hydrochloride Azelastine Hydrochloride
"SPRAY, METERED" NASAL 20140707 ANDA ANDA201846
Apotex Corp. AZELASTINE HYDROCHLORIDE 205.5 ug/1 "Histamine H1 Re
60505-1003_2ccf65f3-660f-5a79-848f-b1ba6ea74d03 60505-1003 HUMAN PRESCRIPTI
ON DRUG Ketorolac Tromethamine ketorolac tromethamine SOLUTION/ DROPS
OPHTHALMIC 20091207 ANDA ANDA076109 Apotex Corp.
matory Drug [EPC]"
60505-1201_cdeeec9b-bf2a-f606-e4f0-3589fcb45968 60505-1201 HUMAN PRESCRIPTI
ON DRUG Cefuroxime Axetil Cefuroxime Axetil "TABLET, FILM CO
CEFUROXIME AXETIL 500 mg/1 "Cephalosporin Antibacterial [EPC],Cepha
60505-1202_cdeeec9b-bf2a-f606-e4f0-3589fcb45968 60505-1202 HUMAN PRESCRIPTI
orp. METFORMIN HYDROCHLORIDE 750 mg/1 "Biguanide [EPC],Biguanides [Che
mical/Ingredient]"
60505-2502_fe1ea007-6d6e-1d29-5bd0-6ac7174b6136 60505-2502 HUMAN PRESCRIPTI
ON DRUG LEFLUNOMIDE LEFLUNOMIDE TABLET ORAL 20050913
ANDA ANDA077090 Apotex Corp. LEFLUNOMIDE 10 mg/1 Antirheu
matic Agent [EPC]
60505-2503_fe1ea007-6d6e-1d29-5bd0-6ac7174b6136 60505-2503 HUMAN PRESCRIPTI
ON DRUG LEFLUNOMIDE LEFLUNOMIDE TABLET ORAL 20050913
ANDA ANDA077090 Apotex Corp. LEFLUNOMIDE 20 mg/1 Antirheu
matic Agent [EPC]
60505-2510_91de48b6-a7cc-438b-89ad-50ae3cb5ee67 60505-2510 HUMAN PRESCRIPTI
ON DRUG FOSINOPRIL Na FOSINOPRIL Sodium TABLET ORAL 20050518
ANDA ANDA076906 Apotex Corp. FOSINOPRIL SODIUM 10 mg/1
ibitors [MoA]"
ibitors [MoA]"
ibitors [MoA]"
60505-2518_e8d2ece1-7be8-2124-62a5-7ab01b5f92f4 60505-2518 HUMAN PRESCRIPTI
ON DRUG Citalopram citalopram "TABLET, FILM COATED" ORAL
20110801 ANDA ANDA077046 Apotex Corp. CITALOPRAM HYDRO
BROMIDE 10 mg/1 "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inh
ibitors [MoA]"
ON DRUG Citalopram citalopram hydrobromide "TABLET, FILM COATED"
ORAL 20110801 ANDA ANDA077046 Apotex Corp. CITALOPR
ON DRUG Citalopram citalopram hydrobromide "TABLET, FILM COATED"
ORAL 20110801 ANDA ANDA077046 Apotex Corp. CITALOPR
60505-2521_ae576c70-5b30-f19a-8d00-8561a8a93c32 60505-2521 HUMAN PRESCRIPTI
ANDA ANDA077030 Apotex Corp. CILOSTAZOL 50 mg/1 "Phospho
60505-2522_ae576c70-5b30-f19a-8d00-8561a8a93c32 60505-2522 HUMAN PRESCRIPTI
ANDA ANDA077030 Apotex Corp. CILOSTAZOL 100 mg/1 "Phospho
60505-2526_5e67c55c-985d-bac1-788d-a23eebf6c907 60505-2526 HUMAN PRESCRIPTI
ANDA ANDA077667 Apotex Corp. MODAFINIL 100 mg/1 "Central
Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomim
etic-like Agent [EPC]" CIV
60505-2527_5e67c55c-985d-bac1-788d-a23eebf6c907 60505-2527 HUMAN PRESCRIPTI
ANDA ANDA077667 Apotex Corp. MODAFINIL 200 mg/1 "Central
60505-2528_98b9cda0-e012-28b2-3792-1d2eabe80fc9 60505-2528 HUMAN PRESCRIPTI
ON DRUG ziprasidone hydrochloride Ziprasidone HCl CAPSULE ORAL
20120514 ANDA ANDA077561 Apotex Corp. ZIPRASIDONE HYDR
OCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC]
60505-2534_52d80b2c-fd40-7189-0b65-9d00effaad85 60505-2534 HUMAN PRESCRIPTI
20080409 ANDA ANDA077747 Apotex Corp. OXCARBAZEPINE
60505-2539_0c02a8f0-362a-8298-b586-e950c8e6a6f4 60505-2539 HUMAN PRESCRIPTI
Apotex Corp. AMOXICILLIN; CLAVULANATE POTASSIUM 250; 125 mg/1; mg
/1 "Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],
beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]"
60505-2542_52b7eaa1-8ade-dd85-5648-ed6d8d31f021 60505-2542 HUMAN PRESCRIPTI
ON DRUG Galantamine galantamine hydrobromide "TABLET, FILM CO
60505-2545_026ed15d-c1ff-cbc9-6d3c-2ce9acf5c66f 60505-2545 HUMAN PRESCRIPTI
ON DRUG Zonisamide Zonisamide CAPSULE ORAL 20051222
ANDA ANDA077642 Apotex Corp. ZONISAMIDE 25 mg/1 "Anti-ep
ivity [PE]"
ivity [PE]"
ivity [PE]"
60505-2551_c5d2a3ad-2e5e-14f3-44a4-bee0b7a76b86 60505-2551 HUMAN PRESCRIPTI
20060915 ANDA ANDA077661 Apotex Corp. GABAPENTIN
60505-2552_c5d2a3ad-2e5e-14f3-44a4-bee0b7a76b86 60505-2552 HUMAN PRESCRIPTI
20060915 ANDA ANDA077661 Apotex Corp. GABAPENTIN
60505-2553_2c67b478-e382-15a5-f7d1-46b80cd6a6de 60505-2553 HUMAN PRESCRIPTI
ANDA ANDA077882 Apotex Corp. MELOXICAM 7.5 mg/1 "Cycloox
60505-2554_2c67b478-e382-15a5-f7d1-46b80cd6a6de 60505-2554 HUMAN PRESCRIPTI
ANDA ANDA077882 Apotex Corp. MELOXICAM 15 mg/1 "Cycloox
60505-2575_fed795ea-8d30-3839-6861-d6636f4c9e69 60505-2575 HUMAN PRESCRIPTI
ON DRUG Balsalazide Disodium Balsalazide Disodium CAPSULE ORAL
20071228 ANDA ANDA077883 Apotex Corp. BALSALAZIDE DISO
DIUM 750 mg/1 "Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/In
gredient]"
60505-2578_7699e0c0-9dbc-12d5-207e-6c7fede52d3a 60505-2578 HUMAN PRESCRIPTI
ATORVASTATIN CALCIUM 10 mg/1 "HMG-CoA Reductase Inhibitor [EPC],Hydro
60505-2581_6cf5afc8-4ec1-e088-2a7f-2d0b9bcc1d64 60505-2581 HUMAN PRESCRIPTI
ORAL 20110718 ANDA ANDA065507 Apotex Corp. AZITHROM
YCIN DIHYDRATE 250 mg/1 "Macrolide Antimicrobial [EPC],Macrolides [Chemi
cal/Ingredient]"
60505-2582_6cf5afc8-4ec1-e088-2a7f-2d0b9bcc1d64 60505-2582 HUMAN PRESCRIPTI
cal/Ingredient]"
60505-2583_37bbd1b6-957b-0489-c334-614ac4e3d0ba 60505-2583 HUMAN PRESCRIPTI
cal/Ingredient]"
60505-2592_84ad6e01-5087-2a0d-27e5-d0c28e6004ea 60505-2592 HUMAN PRESCRIPTI
20080804 ANDA ANDA077982 Apotex Corp. ALENDRONATE SODI
t]"
t]"
t]"
t]"
60505-2597_9b2235c6-0453-bf8c-9ffd-0010ccee94f1 60505-2597 HUMAN PRESCRIPTI
ON DRUG CABERGOLINE CABERGOLINE TABLET ORAL 20130308
ANDA ANDA201503 Apotex Corp. CABERGOLINE 0.5 mg/1 "Ergolin
es [Chemical/Ingredient],Ergot Derivative [EPC]"
60505-2604_02cbbddc-d65c-0b8e-d5ad-b6a6f55453ba 60505-2604 HUMAN PRESCRIPTI
60505-2605_02cbbddc-d65c-0b8e-d5ad-b6a6f55453ba 60505-2605 HUMAN PRESCRIPTI
60505-2606_00d934fc-3959-1b5b-3471-33fde154e00a 60505-2606 HUMAN PRESCRIPTI
20070905 ANDA ANDA078165 Apotex Corp. CARVEDILOL
3.125 mg/1 "Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists
[MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Ad
renergic Blocker [EPC]"
25 mg/1 "Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists
60505-2633_49c67999-d4cc-282b-b8af-e681aee5c330 60505-2633 HUMAN OTC DRUG
Cetirizine Hydrochloride Cetirizine Hydrochloride "TABLET,
FILM COATED" ORAL 20071227 ANDA ANDA078317 Apotex C
orp. CETIRIZINE HYDROCHLORIDE 10 mg/1
60505-2638_6a85395c-448a-071d-2c18-aef6319cf95a 60505-2638 HUMAN PRESCRIPTI
ON DRUG Hydrochlorothiazide Hydrochlorothiazide "CAPSULE, GELATI
N COATED" ORAL 20080516 ANDA ANDA078389 Apotex C
orp. HYDROCHLOROTHIAZIDE 12.5 mg/1 "Increased Diuresis [PE],Thiazid
e Diuretic [EPC],Thiazides [Chemical/Ingredient]"
60505-2639_6a85395c-448a-071d-2c18-aef6319cf95a 60505-2639 HUMAN PRESCRIPTI
ON DRUG Hydrochlorothiazide Hydrochlorothiazide "CAPSULE, GELATI
N COATED" ORAL 20080516 ANDA ANDA078389 Apotex C
orp. HYDROCHLOROTHIAZIDE 12.5 mg/1 "Increased Diuresis [PE],Thiazid
e Diuretic [EPC],Thiazides [Chemical/Ingredient]"
60505-2640_fb9b1500-f899-16a2-55f6-9c30938759a6 60505-2640 HUMAN PRESCRIPTI
20080129 ANDA ANDA040774 Apotex Corp. HYDROCHLOROTHIAZ
IDE 25 mg/1 "Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazid
60505-2641_fb9b1500-f899-16a2-55f6-9c30938759a6 60505-2641 HUMAN PRESCRIPTI
20080129 ANDA ANDA040774 Apotex Corp. HYDROCHLOROTHIAZ
IDE 50 mg/1 "Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazid
60505-2642_7cd5fd99-ea7f-432d-aa05-8c0ab4fffb75 60505-2642 HUMAN PRESCRIPTI
ANDA ANDA078917 Apotex Corp. BICALUTAMIDE 50 mg/1 "Androge
n Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC]"
60505-2644_e5807cf2-9c18-5218-0ede-d80112eea098 60505-2644 HUMAN PRESCRIPTI
ON DRUG Tramadol hydrochloride and acetaminophen Tramadol hydroch
loride and acetaminophen TABLET ORAL 20140830 ANDA
ANDA078778 Apotex Corp. ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325; 37.
5 mg/1; mg/1 "Full Opioid Agonists [MoA],Opioid Agonist [EPC]"
CIV
60505-2648_d283d59f-c580-e069-6426-420de5fb633c 60505-2648 HUMAN PRESCRIPTI
"CAPSULE, GELATIN COATED" ORAL 20120206 ANDA ANDA0788
68 Apotex Corp. TIZANIDINE HYDROCHLORIDE 2 mg/1 "Adrener
gic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]"
60505-2656_ff4ecb50-9714-6f6b-3059-3ae7de33f204 60505-2656 HUMAN PRESCRIPTI
Apotex Corp. HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg
/1 "Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-spa
ring Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [C
60505-2657_ff4ecb50-9714-6f6b-3059-3ae7de33f204 60505-2657 HUMAN PRESCRIPTI
Apotex Corp. HYDROCHLOROTHIAZIDE; TRIAMTERENE 50; 75 mg/1; mg/1
"Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diu
retic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/
Ingredient]"
60505-2660_07ec7d47-fe3d-3207-6da5-b23c8dd670a5 60505-2660 HUMAN PRESCRIPTI
ON DRUG Flecainide Acetate flecainide acetate TABLET ORAL
20090709 ANDA ANDA079164 Apotex Corp. FLECAINIDE ACETA
TE 50 mg/1 Antiarrhythmic [EPC]
60505-2740_a542ca0c-8633-f5cb-9ff3-ee39fc3abc9f 60505-2740 HUMAN PRESCRIPTI
TENDED RELEASE" ORAL 20121119 ANDA ANDA200878 Apotex C
orp. VERAPAMIL HYDROCHLORIDE 120 mg/1 "Calcium Channel Antagonists [Mo
60505-2780_5ae0a445-55aa-2a65-0f93-0a9d2e520704 60505-2780 HUMAN PRESCRIPTI
ORAL 20120911 ANDA ANDA078777 Apotex Corp. ESCITALO
60505-2805_ec92637d-8ed7-a795-4556-c069bb36e71f 60505-2805 HUMAN PRESCRIPTI
ON DRUG Carbamazepine Carbamazepine "CAPSULE, EXTENDED RELEASE"
ORAL 20120323 ANDA ANDA078986 Apotex Corp. CARBAMAZ
EPINE 100 mg/1 "Anti-epileptic Agent [EPC],Decreased Central Nervous Sy
stem Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450
3A4 Inducers [MoA]"
3A4 Inducers [MoA]"
3A4 Inducers [MoA]"
60505-2850_252ba55f-c24b-d4a3-27ae-ed0ebf29d7a3 60505-2850 HUMAN PRESCRIPTI
ON DRUG Alfuzosin Hydrochloride Alfuzosin Hydrochloride "TABLET, EXTENDE
orp. ALFUZOSIN HYDROCHLORIDE 10 mg/1 "Adrenergic alpha-Antagonists [M
oA],alpha-Adrenergic Blocker [EPC]"
60505-2865_3d1b7e5d-5dd4-6fdb-4ec3-3d7090b8f547 60505-2865 HUMAN PRESCRIPTI
ON DRUG Ropinirole Ropinirole "TABLET, FILM COATED" ORAL
20130329 ANDA ANDA079165 Apotex Corp. ROPINIROLE HYDRO
CHLORIDE 0.25 mg/1 "Dopamine Agonists [MoA],Nonergot Dopamine Agoni
st [EPC]"
CHLORIDE 0.5 mg/1 "Dopamine Agonists [MoA],Nonergot Dopamine Agoni
st [EPC]"
CHLORIDE 1 mg/1 "Dopamine Agonists [MoA],Nonergot Dopamine Agoni
st [EPC]"
st [EPC]"
st [EPC]"
st [EPC]"
st [EPC]"
60505-2875_175fc12a-823f-4a32-8108-e6121af0f275 60505-2875 HUMAN PRESCRIPTI
ANDA ANDA079116 Apotex Corp. RAMIPRIL 1.25 mg/1 "Angiote
[MoA]"
ANDA ANDA079116 Apotex Corp. RAMIPRIL 2.5 mg/1 "Angiote
[MoA]"
ANDA ANDA079116 Apotex Corp. RAMIPRIL 5 mg/1 "Angiote
[MoA]"
ANDA ANDA079116 Apotex Corp. RAMIPRIL 10 mg/1 "Angiote
[MoA]"
60505-2880_aa1e15d9-730b-089b-fd92-fe8d6f4abbc2 60505-2880 HUMAN OTC DRUG
Ranitidine Ranitidine Hydrochloride "TABLET, FILM COATED"
ORAL 20130715 ANDA ANDA200172 Apotex Corp. RANITIDI
60505-2881_75f051d3-142c-9892-e6ed-832409de096f 60505-2881 HUMAN OTC DRUG
Ranitidine Ranitidine hydrochloride "TABLET, FILM COATED"
ORAL 20050124 ANDA ANDA075167 Apotex Corp. RANITIDI
60505-2915_66796af2-f111-a905-2bda-4a188f4eaace 60505-2915 HUMAN PRESCRIPTI
ANDA ANDA090150 Apotex Corp. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
60505-2985_90606112-256a-d8c4-ef28-e88950863031 60505-2985 HUMAN PRESCRIPTI
ON DRUG Anastrozole Anastrozole "TABLET, FILM COATED" ORAL
20120531 ANDA ANDA200654 Apotex Corp. ANASTROZOLE
1 mg/1 "Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA]"
60505-2995_db8f5f69-7a4d-9dfe-67cb-11cc387e82cb 60505-2995 HUMAN PRESCRIPTI
ON DRUG Duloxetine Hydrochloride Duloxetine Hydrochloride
"CAPSULE, DELAYED RELEASE" ORAL 20140613 ANDA ANDA2020
45 Apotex Corp. DULOXETINE HYDROCHLORIDE 20 mg/1 "Norepin
60505-3096_80396f51-7e78-f6c2-5234-3191a294f9ce 60505-3096 HUMAN PRESCRIPTI
ON DRUG Risedronate Sodium Risedronate Sodium "TABLET, FILM CO
RISEDRONATE SODIUM ANHYDROUS 75 mg/1 "Bisphosphonate [EPC],Diphosphon
60505-3097_80396f51-7e78-f6c2-5234-3191a294f9ce 60505-3097 HUMAN PRESCRIPTI
ON DRUG Risedronate Sodium Risedronate Sodium "TABLET, FILM CO
RISEDRONATE SODIUM ANHYDROUS 150 mg/1 "Bisphosphonate [EPC],Diphosphon
60505-3110_a5e8111e-2e15-4f34-cdd5-225afc99c04a 60505-3110 HUMAN PRESCRIPTI
20120423 ANDA ANDA090798 Apotex Corp. OLANZAPINE
2.5 mg/1 Atypical Antipsychotic [EPC]
5 mg/1 Atypical Antipsychotic [EPC]
7.5 mg/1 Atypical Antipsychotic [EPC]
60505-3120_21d432da-766a-155a-f3f0-eccb537a7586 60505-3120 HUMAN PRESCRIPTI
ON DRUG Fenofibrate Fenofibrate CAPSULE ORAL 20130726
ANDA ANDA202252 Apotex Corp. FENOFIBRATE 43 mg/1 "Peroxis
60505-3121_21d432da-766a-155a-f3f0-eccb537a7586 60505-3121 HUMAN PRESCRIPTI
ON DRUG Fenofibrate Fenofibrate CAPSULE ORAL 20130726
ANDA ANDA202252 Apotex Corp. FENOFIBRATE 130 mg/1 "Peroxis
60505-3130_fe59446a-488f-93ca-f9bf-6c43ab3a7276 60505-3130 HUMAN PRESCRIPTI
QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC]
60505-3145_2d3a7982-39c4-f623-294c-3d629f16eadb 60505-3145 HUMAN PRESCRIPTI
ON DRUG Cevimeline Hydrochloride cevimeline hydrochloride
CAPSULE ORAL 20121008 ANDA ANDA091260 Apotex Corp.
CEVIMELINE HYDROCHLORIDE 30 mg/1 "Cholinergic Muscarinic Agonists
[MoA],Cholinergic Receptor Agonist [EPC]"
60505-3220_86dc9e23-c5a2-8361-4b5d-80b0d6109c98 60505-3220 HUMAN PRESCRIPTI
20130220 ANDA ANDA091072 Apotex Corp. RIVASTIGMINE TAR
TRATE 1.5 mg/1 "Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitor
s [MoA]"
TRATE 3 mg/1 "Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitor
s [MoA]"
TRATE 4.5 mg/1 "Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitor
s [MoA]"
TRATE 6 mg/1 "Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitor
s [MoA]"
60505-3245_106f8caf-2c44-36a3-53ef-f7929499316c 60505-3245 HUMAN PRESCRIPTI
ON DRUG FAMCICLOVIR FAMCICLOVIR "TABLET, FILM COATED" ORAL
20111220 ANDA ANDA091480 Apotex Corp. FAMCICLOVIR
125 mg/1 "DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog D
NA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient]"
60505-3250_f0758d18-70f7-0681-0f67-b2a0dbb955f8 60505-3250 HUMAN PRESCRIPTI
20140103 ANDA ANDA202941 Apotex Corp. LAMIVUDINE
100 mg/1 "Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhib
itor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase
Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Trans
criptase Inhibitors [MoA]"
60505-3251_c4fb4148-5693-f27c-ff69-adc021f93091 60505-3251 HUMAN PRESCRIPTI
ON DRUG LAMIVUDINE lamivudine "TABLET, FILM COATED" ORAL
60505-3252_c4fb4148-5693-f27c-ff69-adc021f93091 60505-3252 HUMAN PRESCRIPTI
ON DRUG LAMIVUDINE lamivudine "TABLET, FILM COATED" ORAL
60505-3255_5d4c6d2c-0b68-3c2c-ac42-1131070308bc 60505-3255 HUMAN PRESCRIPTI
ON DRUG Letrozole Letrozole "TABLET, FILM COATED" ORAL
20120531 ANDA ANDA091303 Apotex Corp. LETROZOLE
2.5 mg/1 "Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA]"
60505-3275_cf4cacb9-b587-2fa1-e8fb-f03382b08bc8 60505-3275 HUMAN PRESCRIPTI
ON DRUG Olanzapine Olanzapine "TABLET, ORALLY DISINTEGRATING"
ORAL 20111024 ANDA ANDA091265 Apotex Corp. OLANZAPI
NE 5 mg/1 Atypical Antipsychotic [EPC]
60505-3280_f60b9b5f-f7d9-cb82-896f-0e91467344ee 60505-3280 HUMAN PRESCRIPTI
ON DRUG Levetiracetam Levetiracetam "TABLET, EXTENDED RELEASE"
ORAL 20110912 ANDA ANDA091261 Apotex Corp. LEVETIRA
60505-3404_a2ad6796-79e2-69a7-4d39-052bc821d757 60505-3404 HUMAN PRESCRIPTI
ON DRUG Sildenafil Sildenafil "TABLET, FILM COATED" ORAL
20121106 ANDA ANDA091379 Apotex Corp. SILDENAFIL CITRA
TE 20 mg/1 "Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5
Inhibitors [MoA]"
60505-3438_3b64b370-6c29-8d83-7647-22dd8ecb863f 60505-3438 HUMAN PRESCRIPTI
ON DRUG Selegiline Hydrochloride Selegiline Hydrochloride
TABLET ORAL 19970706 ANDA ANDA074871 Apotex Corp.
SELEGILINE HYDROCHLORIDE 5 mg/1 "Monoamine Oxidase Inhibitor [EP
C],Monoamine Oxidase Inhibitors [MoA],Monoamine Oxidase Type B Inhibitor [EPC],M
onoamine Oxidase-B Inhibitors [MoA]"
60505-3454_3fbba8ec-742b-d899-b0b4-03223e4a918a 60505-3454 HUMAN PRESCRIPTI
ON DRUG TROSPIUM CHLORIDE TROSPIUM CHLORIDE TABLET ORAL
20121015 ANDA ANDA091513 Apotex Corp. TROSPIUM CHLORID
E 20 mg/1 "Cholinergic Muscarinic Antagonist [EPC],Cholinergic Mus
carinic Antagonists [MoA]"
60505-3517_f60b9b5f-f7d9-cb82-896f-0e91467344ee 60505-3517 HUMAN PRESCRIPTI
ON DRUG Levetiracetam Levetiracetam "TABLET, EXTENDED RELEASE"
ORAL 20110912 ANDA ANDA091261 Apotex Corp. LEVETIRA
60505-3527_73fbd878-eca5-f707-511e-5afa2fac0b20 60505-3527 HUMAN PRESCRIPTI
ON DRUG Tolterodine Tartrate Tolterodine Tartrate "TABLET, FILM CO
TOLTERODINE TARTRATE 1 mg/1 "Cholinergic Muscarinic Antagonist [EPC]
60505-3528_73fbd878-eca5-f707-511e-5afa2fac0b20 60505-3528 HUMAN PRESCRIPTI
ON DRUG Tolterodine Tartrate Tolterodine Tartrate "TABLET, FILM CO
TOLTERODINE TARTRATE 2 mg/1 "Cholinergic Muscarinic Antagonist [EPC]
60505-3547_6fb95a13-3249-c5d5-5e95-b7dfcc9e81e8 60505-3547 HUMAN PRESCRIPTI
ON DRUG IRBESARTAN IRBESARTAN "TABLET, FILM COATED" ORAL
20121016 ANDA ANDA200832 Apotex Corp. IRBESARTAN
75 mg/1 "Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor
Blocker [EPC]"
Blocker [EPC]"
Blocker [EPC]"
60505-3603_d66e6011-c7ef-d804-d1cb-f78c2e0426c3 60505-3603 HUMAN PRESCRIPTI
ON DRUG Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlo
rothiazide "TABLET, FILM COATED" ORAL 20121016 ANDA
ANDA201505 Apotex Corp. HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5; 150
mg/1; mg/1 "Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor
Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemic
al/Ingredient]"
60505-3604_d66e6011-c7ef-d804-d1cb-f78c2e0426c3 60505-3604 HUMAN PRESCRIPTI
ANDA201505 Apotex Corp. HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5; 300
al/Ingredient]"
60505-3638_4e51f884-e586-b989-728a-6c67eeab53e4 60505-3638 HUMAN PRESCRIPTI
ON DRUG Tranexamic Acid Tranexamic Acid TABLET ORAL 20140127
ANDA ANDA202286 Apotex Corp. TRANEXAMIC ACID 650 1-Jan "Antifib
rinolytic Agent [EPC],Decreased Fibrinolysis [PE]"
60505-3758_b0744b28-b68c-c6c2-21ac-bd0449735ec8 60505-3758 HUMAN PRESCRIPTI
ON DRUG Candesartan Cilexetil and Hydrochlorothiazide Candesartan Cile
xetil and Hydrochlorothiazide TABLET ORAL 20121204 ANDA
ANDA202884 Apotex Corp. CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE
16; 12.5 mg/1; mg/1 "Angiotensin 2 Receptor Antagonists [MoA],Angiot
32; 12.5 mg/1; mg/1 "Angiotensin 2 Receptor Antagonists [MoA],Angiot
60505-3778_d1604f29-b67b-4766-8e45-e56aeeaad24c 60505-3778 HUMAN PRESCRIPTI
ENERIC NDA020699 Apotex Corp. VENLAFAXINE HYDROCHLORIDE 37.5
ENERIC NDA020699 Apotex Corp. VENLAFAXINE HYDROCHLORIDE 75
ENERIC NDA020699 Apotex Corp. VENLAFAXINE HYDROCHLORIDE 150
60505-3806_97709653-c148-fb5c-b9a2-bab9a2e2269d 60505-3806 HUMAN PRESCRIPTI
ON DRUG valsartan and hydrochlorothiazide valsartan and hydrochlor
othiazide "TABLET, FILM COATED" ORAL 20130321 ANDA
ANDA203026 Apotex Corp. HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 80
al/Ingredient]"
al/Ingredient]"
ANDA203026 Apotex Corp. HYDROCHLOROTHIAZIDE; VALSARTAN 25; 160 mg/1; mg
/1 "Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker
[EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingre
dient]"
al/Ingredient]"
ANDA203026 Apotex Corp. HYDROCHLOROTHIAZIDE; VALSARTAN 25; 320 mg/1; mg
/1 "Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker
[EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingre
dient]"
60505-3992_65ea3322-6688-acce-9200-ecc1199f1477 60505-3992 HUMAN PRESCRIPTI
ORAL 20120517 ANDA ANDA076274 Apotex Corp. CLOPIDOG
60505-5306_1a7055b7-8c7e-68e5-4010-5c4d3e5b49cb 60505-5306 HUMAN PRESCRIPTI
60505-5307_1a7055b7-8c7e-68e5-4010-5c4d3e5b49cb 60505-5307 HUMAN PRESCRIPTI
60505-6076_04f83cbb-e4c0-e1fa-ccdc-90d6917f97e3 60505-6076 HUMAN PRESCRIPTI
ON DRUG Azithromycin "azithromycin for injection injection, powder, l
yophilized, for solution" INJECTION INTRAVENOUS 20100425
ANDA ANDA065501 APOTEX CORP. AZITHROMYCIN MONOHYDRATE 500
mg/10mL "Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]"
60505-6078_f423f9fe-8f02-4ca9-b2a7-37ecc89e7f65 60505-6078 HUMAN PRESCRIPTI
ON DRUG FONDAPARINUX SODIUM fondaparinux sodium "INJECTION, SOLU
TION" SUBCUTANEOUS 20110718 NDA NDA021345 Apotex C
orp. FONDAPARINUX SODIUM 2.5 mg/.5mL "Factor Xa Inhibitor [EPC],Facto
r Xa Inhibitors [MoA]"
orp. FONDAPARINUX SODIUM 5 mg/.4mL "Factor Xa Inhibitor [EPC],Facto
orp. FONDAPARINUX SODIUM 7.5 mg/.6mL "Factor Xa Inhibitor [EPC],Facto
orp. FONDAPARINUX SODIUM 10 mg/.8mL "Factor Xa Inhibitor [EPC],Facto
60505-6087_6167e1ca-d283-4dbf-80a5-9bfe45df60b3 60505-6087 HUMAN PRESCRIPTI
ON DRUG Ceftriaxone Sodium Ceftriaxone Sodium "INJECTION, POWD
31 Apotex Corp. CEFTRIAXONE SODIUM 1 g/1 "Cephalosporin A
60505-6088_6167e1ca-d283-4dbf-80a5-9bfe45df60b3 60505-6088 HUMAN PRESCRIPTI
ON DRUG Ceftriaxone Sodium Ceftriaxone Sodium "INJECTION, POWD
31 Apotex Corp. CEFTRIAXONE SODIUM 2 g/1 "Cephalosporin A
60505-7001_2799dc9e-fbb6-d205-ae23-5ad3f91193f7 60505-7001 HUMAN PRESCRIPTI
ON DRUG Fentanyl fentanyl "PATCH, EXTENDED RELEASE"
TRANSDERMAL 20100301 ANDA ANDA077775 Apotex Corp.
FENTANYL 25 ug/h "Full Opioid Agonists [MoA],Opioid Agonist [EPC]
" CII
" CII
" CII
" CII
60505-7006_47ced0e4-b457-901c-326b-b84452b14e9d 60505-7006 HUMAN PRESCRIPTI
ON DRUG FENTANYL FENTANYL "PATCH, EXTENDED RELEASE"
" CII
" CII
" CII
" CII
60505-0679_f55a5377-bebd-4087-b131-dcee7562cdb2 60505-0679 HUMAN PRESCRIPTI
Apotex Corporation CEFTRIAXONE SODIUM 100 mg/mL "Cephalosporin A
60505-0681_0ade324c-f975-41df-8806-2ce04e11371f 60505-0681 HUMAN PRESCRIPTI
ON DRUG Cefepime CEFEPIME "INJECTION, POWDER, FOR SOLUTION
orporation CEFEPIME HYDROCHLORIDE 2 g/1 "Cephalosporin Antibacte
rial [EPC],Cephalosporins [Chemical/Ingredient]"
60505-0686_e3a10436-2986-4663-8eee-fe9e94904ccb 60505-0686 HUMAN PRESCRIPTI
ON DRUG Piperacillin and Tazobactam PIPERACILLIN and TAZOBACTAM
"INJECTION, POWDER, FOR SOLUTION" INTRAVENOUS 20090921
ANDA ANDA065386 Apotex Corporation PIPERACILLIN SODIUM; TAZOBACTAM
SODIUM 2; .25 g/10mL; g/10mL "Penicillin-class Antibacterial [EPC],Penicillin
s [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors
[MoA]"
[MoA]"
[MoA]"
60505-0750_ac6a7877-d725-4613-9e41-dd7331c93243 60505-0750 HUMAN PRESCRIPTI
SOLUTION" INTRAMUSCULAR; INTRAVENOUS 20050802 ANDA
ANDA065230 Apotex Corporation CEFTRIAXONE SODIUM 250 mg/1
ANDA065230 Apotex Corporation CEFTRIAXONE SODIUM 1 g/1
60505-0759_a6602b25-55b4-433e-b602-0bfc1e772aa3 60505-0759 HUMAN PRESCRIPTI
ON DRUG Cefoxitin CEFOXITIN "INJECTION, POWDER, FOR SOLUTION
orporation CEFOXITIN SODIUM 1 g/1 "Cephalosporin Antibacte
60505-0760_a6602b25-55b4-433e-b602-0bfc1e772aa3 60505-0760 HUMAN PRESCRIPTI
60505-0761_69dd10a7-c802-412d-8977-0eb4e8238437 60505-0761 HUMAN PRESCRIPTI
60505-0773_8f78d498-49f0-485a-b07b-678ff9aa888f 60505-0773 HUMAN PRESCRIPTI
SODIUM 36; 4.5 g/152mL; g/152mL "Penicillin-class Antibacterial [EPC],Pe
hibitors [MoA]"
60505-0834_0ade324c-f975-41df-8806-2ce04e11371f 60505-0834 HUMAN PRESCRIPTI
69 Apotex Corporation CEFEPIME HYDROCHLORIDE 1 g/1 "Cephalo
sporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]"
60505-6025_1e1581d7-d084-42ec-a3e7-541c5dbf0892 60505-6025 HUMAN PRESCRIPTI
60505-6026_1e1581d7-d084-42ec-a3e7-541c5dbf0892 60505-6026 HUMAN PRESCRIPTI
60505-6030_d6d30d0f-b3c7-40c3-a527-9b237ce38d2a 60505-6030 HUMAN PRESCRIPTI
69 Apotex Corporation CEFEPIME HYDROCHLORIDE 1 g/1 "Cephalo
60505-6031_d6d30d0f-b3c7-40c3-a527-9b237ce38d2a 60505-6031 HUMAN PRESCRIPTI
orporation CEFEPIME HYDROCHLORIDE 2 g/1 "Cephalosporin Antibacte
60505-6103_f55a5377-bebd-4087-b131-dcee7562cdb2 60505-6103 HUMAN PRESCRIPTI
Apotex Corporation CEFTRIAXONE SODIUM 100 mg/mL "Cephalosporin A
57520-0001_18a805a3-dab5-4a5d-a070-2488ad11cdf4 57520-0001 HUMAN OTC DRUG
Additox "Phytolacca decandra, Trifolium pratense, Xanthoxylum fraxineum,
Arsenicum album," LIQUID ORAL 20100128 UNAPPROVED HOMEO
PATHIC Apotheca Company ARSENIC TRIOXIDE; ASPARTAME; ATROPA BELL
ADONNA; BENZALKONIUM CHLORIDE; CHELIDONIUM MAJUS; FORMALDEHYDE; LYCOPODIUM CLAVA
TUM SPORE; METHYLENE CHLORIDE; METHYLPARABEN; PHOSPHORIC ACID; PHYTOLACCA AMERIC
ANA ROOT; PROPYLPARABEN; RED CLOVER; SODIUM BENZOATE; SODIUM CITRATE; TITANIUM D
IOXIDE; ZANTHOXYLUM AMERICANUM BARK; ZINC OXIDE 12; 30; 12; 30; 12; 30; 12; 30;
30; 12; 3; 30; 3; 30; 30; 30; 3; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/
[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0002_7b47c776-97e6-4474-94b1-72f2028930f3 57520-0002 HUMAN OTC DRUG
ASTH HP "Arsenicum album, Belladonna, Ipecacuanha, Kali carbonicum"
LIQUID ORAL 20100201 UNAPPROVED HOMEOPATHIC Apotheca
Company ARSENIC TRIOXIDE; ATROPA BELLADONNA; IPECAC; LOBELIA INFLATA; PO
TASSIUM CARBONATE; SILICON DIOXIDE; SODIUM SULFATE 30; 30; 30; 30; 30; 30;
/mL
57520-0003_e0aaa45b-915e-4a7f-ac0b-599efdce054a 57520-0003 HUMAN OTC DRUG
Bio Wild Oat "Wild oat," LIQUID ORAL 20100204
UNAPPROVED HOMEOPATHIC Apotheca Company BROMUS RAMOSUS FLOWER
200 [hp_C]/mL
57520-0004_48a57590-5e88-44eb-bd9f-44bbbeeaa027 57520-0004 HUMAN OTC DRUG
ASP "Echinacea angustifolia, Hydrastis canadensis, Tabebuia impetigi
nosa, Glandula suprarenalis, Thymus, Thyroidinum, Arsenicum album, Bryonia alba,
Cocculus indicus, Colchicum autumnale," LIQUID ORAL 20100202
UNAPPROVED HOMEOPATHIC Apotheca Company ANAMIRTA COCCULUS SEED;
ARSENIC TRIOXIDE; ASPERGILLUS FLAVUS; BRYONIA ALBA ROOT; COLCHICUM AUTUMNALE BUL
B; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; LEDUM PALUSTRE TWIG; MERCURIC CYANIDE; PU
LSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SODIUM SULFATE; SUS
SCROFA ADRENAL GLAND; TABEBUIA IMPETIGINOSA BARK; THYMUS; THYROID 12; 12;
200; 12; 12; 3; 3; 12; 12; 12; 12; 12; 12; 8; 3; 8; 8 [hp_X]/mL; [hp_X]/mL; [h
L
57520-0005_f51c856b-3152-426d-9f97-f673793b99e5 57520-0005 HUMAN OTC DRUG
Bio White Chestnut "White chestnut," LIQUID ORAL 20100203
UNAPPROVED HOMEOPATHIC Apotheca Company AESCULUS HIPPOCASTANUM F
LOWER 200 [hp_C]/mL
57520-0006_171d2314-3d6a-4bbb-9eff-2d073d511980 57520-0006 HUMAN OTC DRUG
Bio Impatiens "Impatiens," LIQUID ORAL 20100203
UNAPPROVED HOMEOPATHIC Apotheca Company IMPATIENS GLANDULIFERA F
LOWER 200 [hp_C]/mL
57520-0007_2b080b4f-8594-4865-a35d-86e212ca70f7 57520-0007 HUMAN OTC DRUG
Bio Iodine "Colloidal iodine," LIQUID ORAL 20100204
UNAPPROVED HOMEOPATHIC Apotheca Company IODINE 6 [hp_X]/m
L
57520-0008_60ad8f78-ebae-4cb1-9c28-acb3d9fc0bbe 57520-0008 HUMAN OTC DRUG
Bio Water Violet "Water violet," LIQUID ORAL 20100203
UNAPPROVED HOMEOPATHIC Apotheca Company HOTTONIA PALUSTRIS FLOWE
R 200 [hp_C]/mL
57520-0009_2cada499-0223-4a5d-ad74-8308f4bc141a 57520-0009 HUMAN OTC DRUG
Bio Clematis Clematis LIQUID ORAL 20100203
UNAPPROVED HOMEOPATHIC Apotheca Company CLEMATIS VITALBA FLOWER
200 [hp_C]/mL
57520-0010_20d0bbe4-1d91-471b-b24c-dd8e635d6086 57520-0010 HUMAN OTC DRUG
Bio Cerato Cerato LIQUID ORAL 20100203 UNAPPROV
ED HOMEOPATHIC Apotheca Company CERATOSTIGMA WILLMOTTIANUM FLOWE
R 200 [hp_C]/mL
57520-0011_45827f44-bae0-4266-8d64-53e9a13ba01f 57520-0011 HUMAN OTC DRUG
Bio Gorse Gorse LIQUID ORAL 20100203 UNAPPROV
ED HOMEOPATHIC Apotheca Company ULEX EUROPAEUS 200 [hp_C]/m
L
57520-0012_2ab78f0e-28a6-4340-bb10-40431e47e6e5 57520-0012 HUMAN OTC DRUG
Bio Electrolyte "Boricum gluconicum, Calcarea gluconica, Chromium glucon
icum, Cobaltum gluconicum, Cuprum gluconicum, Ferrum gluconicum, Kali gluconicum
," LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC
Apotheca Company "BORON GLUCONATE; CALCIUM GLUCONATE; CHROMIUM GLUCONATE;
COBALTOUS GLUCONATE; COPPER GLUCONATE; FERROUS GLUCONATE; MAGNESIUM GLUCONATE;
MANGANESE GLUCONATE; NICKEL GLUCONATE; POTASSIUM GLUCONATE; POTASSIUM PHOSPHATE,
DIBASIC; SELENIUM DIOXIDE; SODIUM GLUCONATE; TRIBASIC CALCIUM PHOSPHATE; VANADI
UM; ZINC GLUCONATE" 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 6; 6; 9; 8; 6 [hp_X]/m
_X]/mL
57520-0014_dae94ca6-eb8e-4c9e-b62b-6fe048b0750b 57520-0014 HUMAN OTC DRUG
Allergen II "Kali gluconicum, Adrenalinum, Hepar bovinum, Arsenicum
album, Phosphorus, Pulsatilla, Sulphur, Histaminum hydrochloricum," LIQUID
ORAL 20100129 UNAPPROVED HOMEOPATHIC Apotheca Company
ACER NEGUNDO POLLEN; AGROSTIS GIGANTEA TOP; ALFALFA; AMBROSIA ACANTHICARPA POLLE
N; AMBROSIA ARTEMISIIFOLIA; AMBROSIA PSILOSTACHYA POLLEN; ARSENIC TRIOXIDE; BEEF
LIVER; BETULA OCCIDENTALIS POLLEN; CARYA CORDIFORMIS POLLEN; DACTYLIS GLOMERATA
TOP; EPINEPHRINE; FAGUS GRANDIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; HISTAMIN
E DIHYDROCHLORIDE; JUGLANS NIGRA POLLEN; PHLEUM PRATENSE POLLEN; PHOSPHORUS; PLA
TANUS OCCIDENTALIS POLLEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; POTAS
SIUM GLUCONATE; PULSATILLA VULGARIS; QUERCUS RUBRA POLLEN; RED CLOVER; RUMEX ACE
TOSELLA POLLEN; RUMEX CRISPUS POLLEN; SALIX NIGRA POLLEN; SOLIDAGO VIRGAUREA POL
LEN; SULFUR; ULMUS AMERICANA POLLEN 30; 30; 30; 30; 30; 30; 12; 8; 30; 30; 3
0; 8; 30; 30; 30; 30; 30; 12; 30; 30; 30; 6; 12; 30; 30; 30; 30; 30; 30; 12; 30
hp_X]/mL; [hp_X]/mL
57520-0015_f9bfc344-5214-4af2-96e3-a09952346307 57520-0015 HUMAN OTC DRUG
Adrenal Tonic "Aralia quinquefolia, Glycyrrhiza, Sarsaparilla, Avena s
ativa, Glandula suprarenalis bovinum, Adrenalinum," LIQUID ORAL 20100128
UNAPPROVED HOMEOPATHIC Apotheca Company "AMERICAN GINSENG; ARSEN
IC TRIOXIDE; AVENA SATIVA FLOWERING TOP; BOS TAURUS ADRENAL GLAND; EPINEPHRINE;
GLYCYRRHIZA GLABRA; PHOSPHORIC ACID; POTASSIUM PHOSPHATE, DIBASIC; SARSAPARILLA
ROOT; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; VERATRUM ALBUM ROOT" 1; 12; 3
; 8; 30; 1; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/
[hp_X]/mL
57520-0017_815f6b6d-1f2e-4e5f-ac96-840bf1989c12 57520-0017 HUMAN OTC DRUG
Acne "Carbo animalis, Carbo vegetabilis, Kali bichromicum" LIQUID
ACTIVATED CHARCOAL; CARBO ANIMALIS; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; S
EPIA OFFICINALIS JUICE; SILICON DIOXIDE; SODIUM CHLORIDE; SULFUR; ZINC 30; 30;
30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_
57520-0018_e84d8665-9aa3-4836-b913-7c5961f32d99 57520-0018 HUMAN OTC DRUG
Adrenoplex "Chelidonium majus, Echinacea angustifolia" LIQUID
BOS TAURUS ADRENAL GLAND; CHELIDONIUM MAJUS; ECHINACEA ANGUSTIFOLIA; LYCOPODIUM
CLAVATUM SPORE; PHOSPHORIC ACID; SILYBUM MARIANUM SEED; SODIUM CHLORIDE; SUS SCR
OFA SPLEEN 8; 3; 3; 12; 12; 12; 12; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL;
57520-0020_64aa5d52-d164-48b5-9cfb-6ce448cba59f 57520-0020 HUMAN OTC DRUG
Bio Aspen Aspen LIQUID ORAL 20100203 UNAPPROV
ED HOMEOPATHIC Apotheca Company POPULUS TREMULA FLOWERING TOP
200 [hp_C]/mL
57520-0021_cb796b47-2f58-4801-b1a7-9d080a6fd841 57520-0021 HUMAN OTC DRUG
BAC HP "Apis mellifica, Arsenicum album, Belladonna, Chamomilla, Laches
is mutus, Mercurius solubilis, Pulsatilla, Rhus toxicodendron, Silicea,"
Company APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; LACHESIS MU
TA VENOM; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS; PULSATILLA VULGARIS; SILICON
DIOXIDE; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30
_X]/mL; [hp_X]/mL
57520-0022_082fc0bb-037e-48be-b4c1-811449c4209b 57520-0022 HUMAN OTC DRUG
Allerpoll HP "Allium cepa, Ambrosia artemisiaefolia, Arsenicum album,
Euphrasia officinalis, Nux vimica, Phosphorus, Pulsatilla, Solidago virgaurea,
Sulphur," LIQUID ORAL 20100201 UNAPPROVED HOMEOPATHIC
Apotheca Company AMBROSIA ARTEMISIIFOLIA; ARSENIC TRIOXIDE; EUPHRASIA STR
ICTA; ONION; PHOSPHORUS; PULSATILLA VULGARIS; SOLIDAGO VIRGAUREA FLOWERING TOP;
STRYCHNOS NUX-VOMICA SEED; SULFUR 30; 30; 30; 30; 30; 30; 30; 30; 30
_X]/mL; [hp_X]/mL
57520-0023_955796ad-d8f6-4203-ad44-3a4e2cad46fb 57520-0023 HUMAN OTC DRUG
Androbalance "Androstenedione, Dehydroepiandrosterone, Pregenolone, P
rogesterone, Testosterone" SPRAY ORAL 20100201 UNAPPROV
ED HOMEOPATHIC Apotheca Company ANDROSTENEDIONE; PRASTERONE; PRE
GNENOLONE; PROGESTERONE; TESTOSTERONE 6; 6; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [h
p_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0024_6feb738c-16fa-49f8-9b00-7377c1bdea4f 57520-0024 HUMAN OTC DRUG
Amoebatox "Triticum aestivum, Baptisia tinctoria Capsicum anuum, C
olumbo, Fragaria vesca, Hamamelis virginiana, Hydrastis canadensis, Quassia amar
a, Senna, Liver, Pancreas, Spleen, Belladonna, Cinchona officinal" LIQUID
ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; CAPSICUM; CINCHONA OFFICINALIS BARK;
ENTAMOEBA HISTOLYTICA; FRAGARIA VESCA FRUIT; GIARDIA LAMBLIA; GOLDENSEAL; HAMAM
ELIS VIRGINIANA ROOT BARK/STEM BARK; JATEORHIZA CALUMBA ROOT; LYCOPODIUM CLAVATU
M SPORE; NITRIC ACID; PORK LIVER; QUASSIA AMARA WOOD; SENNA LEAF; STRYCHNOS NUX-
VOMICA SEED; SUS SCROFA PANCREAS; SUS SCROFA SPLEEN; TRITICUM AESTIVUM POLLEN
12; 3; 3; 12; 200; 3; 200; 3; 3; 3; 12; 12; 8; 3; 3; 12; 8; 8; 1 [hp_X]/m
_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0025_f31eefe9-428e-4ad9-806a-508b136b566f 57520-0025 HUMAN OTC DRUG
Allerforce "Chondrus crispus, Glycyrrhiza glabra, Sarsaparilla, Zin
giber officinale, Adrenalinum, Allium cepa, Aralia racemosa, Arsenicum album, Ca
lcarea carbonica, Cantharis, Iodium, Natrum carbonicum, Rhus toxi" LIQUID
"ARALIA RACEMOSA ROOT; ARSENIC TRIOXIDE; CHONDRUS; EPINEPHRINE; GINGER; GLYCYRRH
IZA GLABRA; IODINE; LYTTA VESICATORIA; ONION; OYSTER SHELL CALCIUM CARBONATE, CR
UDE; SARSAPARILLA; SODIUM CARBONATE; TOXICODENDRON PUBESCENS LEAF" 12; 12;
3; 8; 3; 3; 12; 12; 12; 12; 3; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/
57520-0026_6ed9809a-a0da-4e65-b921-1f61c85949d0 57520-0026 HUMAN OTC DRUG
ACNEFORCE "Berberis vulgaris, Cimicifuga racemosa, Hydrocotyle asi
atica, Lappa major, Belladonna, Calcarea carbonica, Causticum, Eugenia jambosa,"
Company "ARCTIUM LAPPA ROOT; ATROPA BELLADONNA; BERBERIS VULGARIS ROOT B
ARK; BLACK COHOSH; CAUSTICUM; CENTELLA ASIATICA; EUGENIA JAMBOS; OYSTER SHELL CA
LCIUM CARBONATE, CRUDE; PALLADIUM; POTASSIUM BROMIDE; SEPIA OFFICINALIS JUICE; V
IOLA TRICOLOR" 3; 12; 3; 3; 12; 3; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X
L; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0027_b0ac35e3-8ef1-48af-b4e5-76c696c552e5 57520-0027 HUMAN OTC DRUG
Acetaldehyde Acetaldehyde LIQUID ORAL 20100127
UNAPPROVED HOMEOPATHIC Apotheca Company ACETALDEHYDE 30
[hp_C]/mL
57520-0028_e04d4a94-4a91-4f99-9273-cd6a43dfa30a 57520-0028 HUMAN OTC DRUG
Adaptagen "Aralia quinquefolia, Avena sativa, Capsicum annuum, Gin
kgo biloba, Glycyrrhiza glabra, Hydrocotyle asiatica, Thiaminum hydrochloricum,"
Company ADENOSINE TRIPHOSPHATE; AMERICAN GINSENG; ASCORBIC ACID; AVENA S
ATIVA FLOWERING TOP; BOS TAURUS ADRENAL GLAND; CENTELLA ASIATICA; CHILI PEPPER;
COPPER GLUCONATE; GINKGO; GLYCYRRHIZA GLABRA; IODINE; LEDUM PALUSTRE TWIG; MOLYB
DENUM; PHOSPHORIC ACID; RIBOFLAVIN; SELENIUM; SEPIA OFFICINALIS JUICE; SODIUM CA
RBONATE; SUS SCROFA SPLEEN; THIAMINE HYDROCHLORIDE; THYROID; TRINITROPHENOL; VAN
ADIUM 30; 3; 6; 3; 8; 3; 3; 12; 3; 3; 12; 12; 12; 12; 6; 12; 12; 12; 8; 4; 8;
12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]
/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
hp_X]/mL; [hp_X]/mL
57520-0029_ac9fa519-941a-4432-848e-4a3406cb338d 57520-0029 HUMAN OTC DRUG
Bio Elm "Elm," LIQUID ORAL 20100203 UNAPPROVED HOMEO
PATHIC Apotheca Company ULMUS AMERICANA POLLEN 200 [hp_C]/m
L
57520-0030_f56a68f1-5b95-4082-b522-fbb3131ddfd6 57520-0030 HUMAN OTC DRUG
Bio Olive Olive LIQUID ORAL 20100203 UNAPPROV
ED HOMEOPATHIC Apotheca Company OLEA EUROPAEA FLOWER 200
[hp_C]/mL
57520-0031_966f2217-ccbc-4251-b93e-6614b4d88d03 57520-0031 HUMAN OTC DRUG
Bio Sweet Chestnut Sweet chestnut. LIQUID ORAL 20100203
UNAPPROVED HOMEOPATHIC Apotheca Company CASTANEA SATIVA FLOWER
200 [hp_C]/mL
57520-0032_e56cc7d9-6609-45df-ada6-8a012a10056f 57520-0032 HUMAN OTC DRUG
Bio Walnut Walnut LIQUID ORAL 20100203 UNAPPROV
ED HOMEOPATHIC Apotheca Company JUGLANS REGIA FLOWERING TOP
200 [hp_C]/mL
57520-0033_dfa95519-e07a-4531-afcb-ac73c3160d75 57520-0033 HUMAN OTC DRUG
Bronci HP "Carbo vegetabilis, Cuprum metallicum, Drosera rotundifolia, Ipe
cacuanha, Lachesis mutus, Lobelia inflata, Phosphorus, Pulsatilla, Rumex crispus
, Spongia tosta," LIQUID ORAL 20100204 UNAPPROVED HOMEO
PATHIC Apotheca Company "ACTIVATED CHARCOAL; COPPER; DROSERA ROT
UNDIFOLIA; IPECAC; LACHESIS MUTA VENOM; LOBELIA INFLATA; PHOSPHORUS; PULSATILLA
VULGARIS; RUMEX CRISPUS ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED" 30; 30;
30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_
X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0034_48d1425a-3f8e-412c-9fd7-436467e1b9fe 57520-0034 HUMAN OTC DRUG
Bronchiforce "Althaea officinalis, Lobelia inflata, Rheum officinale,
Verbascum thapsus, Belladonna, Cuprum aceticum," LIQUID ORAL 20100204
UNAPPROVED HOMEOPATHIC Apotheca Company "ALTHAEA OFFICINALIS ROO
T; ATROPA BELLADONNA; CUPRIC ACETATE; DROSERA ROTUNDIFOLIA; IPECAC; LOBARIA PULM
ONARIA; LOBELIA INFLATA; RHEUM OFFICINALE ROOT; SPONGIA OFFICINALIS SKELETON, RO
ASTED; VERBASCUM THAPSUS" 3; 12; 12; 12; 12; 12; 3; 3; 12; 3 [hp_X]/m
57520-0035_a8d5340d-cb24-4114-be5c-bdbca7abf41c 57520-0035 HUMAN OTC DRUG
Asthmaforce "Arnica montana, Asclepias tuberosa, Eriodictyon califor
nicum, Eucalyptus globulus, Lobelia inflata, Plantago major," LIQUID ORAL
20100201 UNAPPROVED HOMEOPATHIC Apotheca Company
ACTIVATED CHARCOAL; ARNICA MONTANA; ARSENIC TRIOXIDE; ASCLEPIAS TUBEROSA; ATROPA
BELLADONNA; BRYONIA ALBA ROOT; ERIODICTYON CALIFORNICUM LEAF; EUCALYPTUS GLOBUL
US LEAF; GRINDELIA CAMPORUM TOP; LOBELIA INFLATA; PLANTAGO MAJOR; POTASSIUM CARB
ONATE; PULSATILLA VULGARIS; RED CLOVER; SODIUM SULFATE 12; 3; 12; 3; 12; 12; 3;
X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/
mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0036_5cf371ad-5633-4d12-9342-5e58f8686d79 57520-0036 HUMAN OTC DRUG
BAC "Echinacea angustifolia, Hydrastis canadensis, lomatium, Myrrha,
Nasturtium aquaticum, Tabebuia impetiginosa, Propolis," LIQUID ORAL
ARSENIC TRIOXIDE; ATROPA BELLADONNA; BOTULINUM TOXIN TYPE A; CLOSTRIDIUM PERFRIN
GENS; ECHINACEA ANGUSTIFOLIA; ESCHERICHIA COLI; GOLDENSEAL; HYPERICUM PERFORATUM
; LOMATIUM DISSECTUM ROOT; MYRRH; PHOSPHORUS; PROPOLIS WAX; PROTEUS MIRABILIS; P
SEUDOMONAS AERUGINOSA; RORIPPA NASTURTIUM-AQUATICUM; SALMONELLA ENTERICA SUBSP.
ENTERICA SEROVAR ENTERITIDIS; SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH; SUS SC
ROFA SPLEEN; TABEBUIA IMPETIGINOSA BARK; THYMUS; THYROID; YERSINIA ENTEROCOLITIC
A 12; 12; 60; 60; 3; 60; 3; 12; 3; 3; 12; 6; 60; 60; 3; 60; 8; 8; 8; 3; 8;
hp_X]/mL; [hp_X]/mL
57520-0037_8f1eb38d-3b59-4f7a-ae45-217021e0bcb3 57520-0037 HUMAN OTC DRUG
BAC (GD) "Echinacea Angustifolia, Hydrastis canadensis, Lomatium Myrrha,
Nasturtium aquaticum, Propolis," LIQUID ORAL 20100202 20150708
UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; ATROPA
BELLADONNA; BOTULINUM TOXIN TYPE A; CLOSTRIDIUM PERFRINGENS; ECHINACEA ANGUSTIF
OLIA; ESCHERICHIA COLI; GOLDENSEAL; HYPERICUM PERFORATUM; LOMATIUM DISSECTUM ROO
T; MYRRH; PHOSPHORUS; PROPOLIS WAX; PROTEUS MIRABILIS; PSEUDOMONAS AERUGINOSA; R
ORIPPA NASTURTIUM-AQUATICUM; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERIT
IDIS; SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH; SUS SCROFA SPLEEN; TABEBUIA IM
PETIGINOSA BARK; THYMUS; THYROID 12; 12; 60; 60; 3; 60; 3; 12; 3; 3; 12;
mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [iU]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [
hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_
X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0038_1189c87f-054d-48cc-adc5-519a48ebfba6 57520-0038 HUMAN OTC DRUG
Bio Mustard Mustard LIQUID ORAL 20100203 UNAPPROV
ED HOMEOPATHIC Apotheca Company BRASSICA RAPA POLLEN 200
[hp_C]/mL
57520-0039_99a22c57-7c98-49c9-be30-6e41e2fa3b24 57520-0039 HUMAN OTC DRUG
Bio Myelin Protein "Brain," SPRAY ORAL 20100203
UNAPPROVED HOMEOPATHIC Apotheca Company PORK BRAIN 12
[hp_X]/mL
57520-0040_c579fca8-76e0-439d-9cd7-9fb7f3ef6a10 57520-0040 HUMAN OTC DRUG
Bio Oak "Oak," LIQUID ORAL 20100203 UNAPPROVED HOMEO
PATHIC Apotheca Company QUERCUS ROBUR FLOWER 200 [hp_C]/m
L
57520-0041_cd98c740-0663-4c60-af17-95d7d7d16500 57520-0041 HUMAN OTC DRUG
Bio Res Q "Star of Bethlehem, Rock rose, Impatiens, Cherry plum, C
lematis," LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC
Apotheca Company CLEMATIS VITALBA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER
; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM; PRUNUS CERASIFERA FLOW
ER 200; 200; 200; 200; 200 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_
C]/mL
57520-0042_ea97ac6f-eedb-4f07-87d8-7ff7003bbfbe 57520-0042 HUMAN OTC DRUG
Bio Willow "Willow," LIQUID ORAL 20100204
UNAPPROVED HOMEOPATHIC Apotheca Company SALIX ALBA FLOWERING TOP
200 [hp_C]/mL
57520-0043_45f6abee-22d8-47c8-a3d1-5841cbfcf145 57520-0043 HUMAN OTC DRUG
Bone Repair HP "Calcarea carbonica, Calcarea fluorica, Calcarea phospho
rica, Fluoricum acidum, Hekla lava, Rhus toxicodendron, Silicea, Symphytum offic
inale" LIQUID ORAL 20100204 UNAPPROVED HOMEOPATHIC
Apotheca Company "CALCIUM FLUORIDE; COMFREY ROOT; HEKLA LAVA; HYDROFLUORI
C ACID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SILICON DIOXIDE; TOXICODENDRON PU
BESCENS LEAF; TRIBASIC CALCIUM PHOSPHATE" 30; 30; 30; 30; 30; 30; 30; 30
_X]/mL
57520-0044_0c12bc1d-c24b-4812-bdb4-4fc98789d48c 57520-0044 HUMAN OTC DRUG
Calciforce "Arnica montana, Chamomilla, Echinacea angustifolia, Sym
phytum officinale, Boron gluconate," LIQUID ORAL 20100205
UNAPPROVED HOMEOPATHIC Apotheca Company "ARNICA MONTANA; BORON G
LUCONATE; CALCIUM FLUORIDE; COMFREY ROOT; ECHINACEA ANGUSTIFOLIA; HEKLA LAVA; LY
COPODIUM CLAVATUM SPORE; MATRICARIA RECUTITA; OYSTER SHELL CALCIUM CARBONATE, CR
UDE; SILICON DIOXIDE; TRIBASIC CALCIUM PHOSPHATE" 3; 6; 12; 3; 3; 12; 12;
3; 30; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0045_b50b0878-8571-4905-bcbb-96fa30144ab0 57520-0045 HUMAN OTC DRUG
Venoforce II "Hamamelis virginiana. Collinsonia canadensis, Aesculus
hippocastanum, Belladonna, Calcarea fluorica, Carduus marianus," LIQUID
ATROPA BELLADONNA; CALCIUM FLUORIDE; CLAVICEPS PURPUREA SCLEROTIUM; COLLINSONIA
CANADENSIS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HORSE CHESTNUT; PULSA
TILLA VULGARIS; SILYBUM MARIANUM SEED; VIPERA BERUS VENOM 12; 12; 12; 3; 3
; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [
hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0046_7b25271f-bb96-4e5e-b37c-0f622753fb39 57520-0046 HUMAN OTC DRUG
Candida Alb Candida albicans LIQUID ORAL 20100205
UNAPPROVED HOMEOPATHIC Apotheca Company CANDIDA ALBICANS
200 [hp_X]/mL
57520-0047_631ca6a1-27ff-4f40-9fc5-a79342cb93ce 57520-0047 HUMAN OTC DRUG
Candida Combo "Candida albicans," LIQUID ORAL 20100205
500 [hp_X]/mL
57520-0048_759cd4b0-65e0-483f-8957-7ade99b20ac5 57520-0048 HUMAN OTC DRUG
Cardio Tonic "Kali muriaticum, Kali phosphoricum, Plantago major, Cac
tus grandiflorus, Digitalis purpurea," LIQUID ORAL 20100208
UNAPPROVED HOMEOPATHIC Apotheca Company "ARTEMISIA ABROTANUM FLO
WERING TOP; DIGITALIS; EGG PHOSPHOLIPIDS; IODINE; LEVOCARNITINE; PLANTAGO MAJOR;
PORK HEART; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SELENICEREUS GRAN
DIFLORUS STEM; SPIGELIA; THYROID; VALINE" 12; 6; 12; 12; 6; 3; 6; 3; 3; 5;
12; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [iU]/mL; [hp_X]/mL; [hp_X]/mL
57520-0049_1c81e730-e359-41cc-83dd-1dacc7736178 57520-0049 HUMAN OTC DRUG
Cardioforce II Cardioforce II LIQUID ORAL 20100208
UNAPPROVED HOMEOPATHIC Apotheca Company "ARTEMISIA ABROTANUM FLO
WERING TOP; BLACK COHOSH; CHELIDONIUM MAJUS; CONVALLARIA MAJALIS; MAGNESIUM SULF
ATE HEPTAHYDRATE; NERIUM OLEANDER LEAF; PEUMUS BOLDUS LEAF; POTASSIUM PHOSPHATE,
DIBASIC; SODIUM CHLORIDE; TARAXACUM OFFICINALE" 3; 3; 3; 3; 5; 8; 3; 3;
/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0050_bfd9db01-6e63-4b35-b753-1466fc227406 57520-0050 HUMAN OTC DRUG
Cardiotone "Adonis vernalis, Strophanthus hispidus, ATP, Cactus gra
ndiflorus, Convallaria majalis, Cor suis," LIQUID ORAL 20100208
UNAPPROVED HOMEOPATHIC Apotheca Company ADENOSINE TRIPHOSPHATE;
ADONIS VERNALIS; BIS(CARBOXYETHYL)GERMANIUM SESQUIOXIDE; CONVALLARIA MAJALIS; DI
GITALIS; MAGNESIUM; PORK HEART; POTASSIUM GLUCONATE; SELENICEREUS GRANDIFLORUS S
TEM; STROPHANTHUS HISPIDUS SEED; THYROID; UBIDECARENONE 6; 3; 8; 6; 12; 6; 6; 6;
; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0051_9c421eb5-f330-4880-9fa5-156f542dcdce 57520-0051 HUMAN OTC DRUG
Quiet Calm Quiet Calm LIQUID ORAL 20100127
UNAPPROVED HOMEOPATHIC Apotheca Company AMMONIUM BROMIDE; ARABIC
A COFFEE BEAN; AVENA SATIVA FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; MATRICAR
IA RECUTITA; PHOSPHORIC ACID; TRYPTOPHAN; VALERIAN 3; 6; 1; 6; 6; 6; 6; 30
_X]/mL
57520-0052_92a880e5-ff0f-4618-8a33-e776e3b3e53f 57520-0052 HUMAN OTC DRUG
Stomach Relief Stomach Relief LIQUID ORAL 20100127
UNAPPROVED HOMEOPATHIC Apotheca Company ACTIVATED CHARCOAL; ARSE
NIC TRIOXIDE; ROBINIA PSEUDOACACIA BARK; STRYCHNOS NUX-VOMICA SEED 30; 30;
12; 12 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL
57520-0053_b828dd0e-67a8-4ed3-bb59-1c17a96bbd1d 57520-0053 HUMAN OTC DRUG
Nighty Nite "Grindelia, Melatonin, Passiflora incarnata," LIQUID
GRINDELIA CAMPORUM TOP; MELATONIN; PASSIFLORA INCARNATA TOP 12; 12; 6
[hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0054_45d6a022-6594-46c9-946a-01888893281d 57520-0054 HUMAN OTC DRUG
Male Energy "Dehydroepiandrosterone, Sabal serrulata, Serotonin, Ori
chitinum, Pituitarum posterium," LIQUID ORAL 20100127
UNAPPROVED HOMEOPATHIC Apotheca Company CONIUM MACULATUM FLOWERI
NG TOP; PRASTERONE; SAW PALMETTO; SEROTONIN; SUS SCROFA PITUITARY GLAND; SUS SCR
OFA TESTICLE; TESTOSTERONE; THYROID 12; 6; 6; 30; 8; 8; 30; 30 [hp_X]/m
L; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL
57520-0055_22247ebe-2603-42f2-907a-09bab93e3aaa 57520-0055 HUMAN OTC DRUG
Ticked "Calendula officinalis, Phytolacca decandra, Borrelia burgdorfer
i, Adrenalinum, Ledum palustre, Aconitum napellus, Arnica montana," LIQUID
ACONITUM NAPELLUS; ARNICA MONTANA; BORRELIA BURGDORFERI; CALENDULA OFFICINALIS F
LOWERING TOP; EPINEPHRINE; LEDUM PALUSTRE TWIG; PHYTOLACCA AMERICANA ROOT
X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0056_01d54a70-307f-4d9d-ab00-fd28bf1ac66c 57520-0056 HUMAN OTC DRUG
High Potency Heal Grief "Ignatia amara, Natrum muriaticum, Staphysagria"
Company DELPHINIUM STAPHISAGRIA SEED; SODIUM CHLORIDE; STRYCHNOS IGNATII
SEED 200; 200; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0057_68fee4fb-8689-4707-830c-e492e79496a9 57520-0057 HUMAN OTC DRUG
Heal Grief Heal Grief LIQUID ORAL 20100126
UNAPPROVED HOMEOPATHIC Apotheca Company DELPHINIUM STAPHISAGRIA
SEED; PHOSPHORIC ACID; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED 12; 30; 12; 30
[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL
57520-0059_18cb2cf7-5b2c-49d4-9b0b-649b130719a0 57520-0059 HUMAN OTC DRUG
Flexible "Rhododendron chrysanthum, Ruta graveolens, Arnica monta
na, Colchicum autumnale, Phytolacca decandra, Urtica urens," LIQUID ORAL
ARNICA MONTANA; CAUSTICUM; COLCHICUM AUTUMNALE BULB; HYPERICUM PERFORATUM; KALMI
A LATIFOLIA LEAF; PHYTOLACCA AMERICANA ROOT; RHODODENDRON AUREUM LEAF; RUTA GRAV
EOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF; URTICA URENS; ZINC 6; 12; 6
; 30; 12; 6; 6; 6; 12; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_
X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0060_d5e1e230-d42b-4b04-8139-4cbd9daa43eb 57520-0060 HUMAN OTC DRUG
Happy Heart "Cactus grandiflorus, Glonoinum, Kali carbonicum, Spigel
ia anthelmia, Gelsemium sempervirens," LIQUID ORAL 20100125
UNAPPROVED HOMEOPATHIC Apotheca Company ACONITUM NAPELLUS; ARNIC
A MONTANA; GELSEMIUM SEMPERVIRENS ROOT; NITROGLYCERIN; POTASSIUM CARBONATE; RANU
NCULUS BULBOSUS; SELENICEREUS GRANDIFLORUS STEM; SPIGELIA; SULFUR 30; 30;
10; 6; 6; 10; 4; 8; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [
57520-0061_04454b6b-ced7-418e-b80b-4e3b281418c5 57520-0061 HUMAN OTC DRUG
"Bye, Bye Ver" "Artemisia vulgaris, Filix mas, Tanacetum vulgare, Teucr
ium marum, Absinthium, Cina, Chenopodium anthelminticum," LIQUID ORAL
ARTEMISIA ABSINTHIUM POLLEN; ARTEMISIA CINA FLOWER; ARTEMISIA VULGARIS ROOT; ASC
ARIS LUMBRICOIDES; CHENOPODIUM AMBROSIOIDES; DRYOPTERIS FILIX-MAS ROOT; ECHINOCO
CCUS GRANULOSUS; ENTEROBIUS VERMICULARIS; GRAPHITE; MERCURIC CHLORIDE; SPIGELIA
ANTHELMIA; TAENIA SAGINATA; TAENIA SOLIUM; TANACETUM VULGARE TOP; TEUCRIUM MARUM
; TURPENTINE 4; 4; 1; 12; 6; 3; 12; 30; 12; 6; 12; 12; 12; 3; 3; 6 [hp_X]/m
_X]/mL
57520-0062_054e5f47-9052-4f59-b35e-9dca6170ce7f 57520-0062 HUMAN OTC DRUG
Adrenal Energy "Berberis vulgarius, Agaricus muscarius, Urtica urens, G
landula suprarenalis, Spleen, Echinacea angustifolia, Atropinum sulphuricum, Cea
nothus americanus," LIQUID ORAL 20100122 UNAPPROVED HOMEO
PATHIC Apotheca Company AMANITA MUSCARIA VAR. MUSCARIA; ATROPINE
SULFATE; BERBERIS VULGARIS ROOT BARK; CEANOTHUS AMERICANUS LEAF; ECHINACEA ANGU
STIFOLIA; SUS SCROFA ADRENAL GLAND; SUS SCROFA SPLEEN; URTICA URENS 30; 30;
3; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [
hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0063_78221b69-4418-48f7-98c8-014c18f821b1 57520-0063 HUMAN OTC DRUG
Cold and Flu Solution Cold and Flu Solution LIQUID ORAL 20100205
UNAPPROVED HOMEOPATHIC Apotheca Company ACONITUM NAPELLUS; ATROP
A BELLADONNA; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; ECHINACEA; EUPATORIUM PER
FOLIATUM FLOWERING TOP; FERRUM PHOSPHORICUM; GELSEMIUM SEMPERVIRENS ROOT
3; 3; 200; 3; 3; 4; 3 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [
hp_C]/mL; [hp_C]/mL
57520-0064_df43a058-a90c-4f15-8e83-e37d0dd0026f 57520-0064 HUMAN OTC DRUG
Cerebraplex "Avena sativa, Capsicum annuum, Hydrocotyle asiatica, Fo
-ti, Ginkgo biloba, Rosmarinus officinalis, Vinca minor, Brain, Baryta carbonica
Apotheca Company "ATROPA BELLADONNA; AVENA SATIVA FLOWERING TOP; BARIUM C
ARBONATE; CENTELLA ASIATICA; CHILI PEPPER; DATURA STRAMONIUM; FALLOPIA MULTIFLOR
A ROOT; GERMANIUM SESQUIOXIDE; GINKGO; PORK BRAIN; POTASSIUM PHOSPHATE, DIBASIC;
ROSEMARY; VINCA MINOR" 12; 3; 12; 3; 3; 12; 3; 12; 3; 6; 12; 3; 3 [hp_X]/m
57520-0065_c55b60c7-9b20-45ce-a315-e1a19d44b503 57520-0065 HUMAN OTC DRUG
Cerebroforce Cerebroforce LIQUID ORAL 20100208
UNAPPROVED HOMEOPATHIC Apotheca Company "ARSENIC TRIOXIDE; CHILI
PEPPER; GELSEMIUM SEMPERVIRENS ROOT; GINKGO; LYCOPODIUM CLAVATUM SPORE; PHOSPHO
RUS; POTASSIUM PHOSPHATE, DIBASIC" 30; 3; 12; 3; 12; 12; 12 [hp_X]/m
57520-0066_25306a12-637b-4cdc-9d0e-2eb8680083c5 57520-0066 HUMAN OTC DRUG
Chemtox "Triticum aestivum, Berberis vulgaris, Glycyrrhiza glabra, Lappa
major, Phytolacca decandra, Rhamnus frangula," LIQUID ORAL 20100209
UNAPPROVED HOMEOPATHIC Apotheca Company "ACETIC ACID; ARCTIUM LA
PPA ROOT; ASPIRIN; ATROPA BELLADONNA; BEEF LIVER; BENZOIC ACID; BENZYL ALCOHOL;
BERBERIS VULGARIS ROOT BARK; BORIC ACID; CHLORINE; CORTICOTROPIN; CORTISONE ACET
ATE; ESTRONE; EUGENOL; FRANGULA ALNUS BARK; FRANGULA ALNUS BARK; FRANGULA PURSHI
ANA BARK; GLYCYRRHIZA GLABRA; ISOPROPYL PALMITATE; LACTIC ACID, DL-; LEAD; LYCOP
ODIUM CLAVATUM SPORE; NITRIC ACID; PETROLATUM; PHENYLBUTAZONE; PHOSPHORIC ACID;
PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; POTASSIUM SORBATE; RED CLOVER; RESORCINOL
; SORBITOL; STEARYL ALCOHOL; STILLINGIA; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA A
DRENAL GLAND; SUS SCROFA LYMPH; THYROID; TRITICUM AESTIVUM POLLEN; XYLITOL; ZANT
HOXYLUM AMERICANUM BARK" 200; 3; 200; 12; 8; 200; 200; 3; 200; 200; 200;
200; 200; 200; 3; 3; 3; 3; 200; 200; 200; 12; 12; 200; 200; 12; 12; 3; 200; 3; 2
[hp_X]/mL
57520-0067_2524f404-07b4-49e3-97d7-47bd815080d6 57520-0067 HUMAN OTC DRUG
Circulatone "Fagopyrum esculentum, Magnesia muriatica" LIQUID
ARNICA MONTANA; ARSENIC TRIIODIDE; BARIUM CHLORIDE DIHYDRATE; BEEF HEART; CALCIU
M IODIDE; CHOLESTEROL; CITRUS BIOFLAVONOIDS; CONIUM MACULATUM FLOWERING TOP; FAG
OPYRUM ESCULENTUM; GOLD TRICHLORIDE; LEAD; MAGNESIUM CHLORIDE; PHOSPHORUS; POTAS
SIUM IODIDE; THYROID 30; 12; 12; 8; 12; 12; 8; 12; 3; 12; 12; 3; 30; 12; 8
/mL
57520-0069_5275983b-97db-46af-9a3c-dd399b141d48 57520-0069 HUMAN OTC DRUG
Contact Allergy "Rhus toxicodendron, Rhus diversiloba, Rhus venenate, Ur
itica dioica, Anacardium orientale, Graphites," LIQUID ORAL 20100209
UNAPPROVED HOMEOPATHIC Apotheca Company DAPHNE MEZEREUM BARK; GR
APHITE; SEMECARPUS ANACARDIUM JUICE; TOXICODENDRON DIVERSILOBUM LEAF; TOXICODEND
RON PUBESCENS LEAF; TOXICODENDRON VERNIX LEAFY TWIG; URTICA DIOICA; XEROPHYLLUM
ASPHODELOIDES 12; 12; 12; 30; 30; 30; 30; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL;
57520-0070_bab18474-03a1-40aa-b33f-dcbce4521fbe 57520-0070 HUMAN OTC DRUG
Convoforce "Belladonna, Bufo vulgaris, Cicuta virosa, Cina, Cuprum
metallicum, Hyoscyamus niger, Muschus, Stramonium," LIQUID ORAL 20100209
UNAPPROVED HOMEOPATHIC Apotheca Company ARTEMISIA CINA FLOWER; A
TROPA BELLADONNA; BUFO BUFO CUTANEOUS GLAND; CICUTA VIROSA ROOT; COPPER; DATURA
STRAMONIUM; HYOSCYAMUS NIGER; MOSCHUS MOSCHIFERUS MUSK SAC RESIN 12; 12;
57520-0071_128989f0-8ade-4b30-966a-41f376739879 57520-0071 HUMAN OTC DRUG
Cough-HP Cough-HP LIQUID ORAL 20100209
UNAPPROVED HOMEOPATHIC Apotheca Company "ARSENIC TRIOXIDE; BRYON
IA ALBA ROOT; CUPRIC ACETATE; DROSERA ROTUNDIFOLIA; IPECAC; PHOSPHORUS; POTASSIU
M CARBONATE; PULSATILLA VULGARIS; SPONGIA OFFICINALIS SKELETON, ROASTED"
30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/
mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0075_80238f18-057d-4608-9bf0-8e6cd2755a3e 57520-0075 HUMAN OTC DRUG
CV HP "Lycopus virginicus, Valeriana officinalis, Aurum metallicum, Ca
ctus grandiflorus, Cuprum aceticum," LIQUID ORAL 20100210
UNAPPROVED HOMEOPATHIC Apotheca Company CUPRIC ACETATE; DIGITALI
S; GOLD; LYCOPUS; PHOSPHORUS; PULSATILLA VULGARIS; SELENICEREUS GRANDIFLORUS STE
M; SODIUM CHLORIDE; VALERIAN 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/m
L; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL;
[hp_X]/mL
57520-0076_a1745a97-beb6-4b8b-ab48-e8b2626a6736 57520-0076 HUMAN OTC DRUG
Cystoforce Cystoforce LIQUID ORAL 20100210
UNAPPROVED HOMEOPATHIC Apotheca Company APIS MELLIFERA; ARCTOSTA
PHYLOS UVA-URSI LEAF; ARSENIC TRIOXIDE; CALCIUM SULFIDE; LYTTA VESICATORIA; SARS
APARILLA; SOLIDAGO VIRGAUREA FLOWERING TOP 12; 3; 12; 12; 12; 3; 3 [hp_X]/m
57520-0077_129dde64-7be3-4373-8be6-8a6fab02b86a 57520-0077 HUMAN OTC DRUG
Cystoges "Berberis vulgaris, Cantharis, Clematis erecta" LIQUID
BERBERIS VULGARIS FRUIT; CANIS LUPUS FAMILIARIS MILK; CLEMATIS RECTA FLOWERING T
OP; DELPHINIUM STAPHISAGRIA SEED; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA;
PULSATILLA VULGARIS; SARSAPARILLA; SEPIA OFFICINALIS JUICE 30; 30; 30; 30;
30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [
57520-0079_f4f66c52-3aa7-4153-a696-98a5b68aae08 57520-0079 HUMAN OTC DRUG
Dentox "Berberis vulgaris, Glycyrrhiza glabra, Lappa major, Phytolacca
decandra, Stillingia sylvatica, Trifolium pratense, Lymph (suis), Medulla ossis
(suis), Thymus (suis)," LIQUID ORAL 20100210 UNAPPROVED HOMEO
PATHIC Apotheca Company "ARCTIUM LAPPA ROOT; BERBERIS VULGARIS R
OOT BARK; CALCIUM FLUORIDE; COPPER; EUGENOL; FORMALDEHYDE; GLYCYRRHIZA GLABRA; G
OLD; LIDOCAINE; MERCURIUS SOLUBILIS; MOLYBDENUM; NICKEL; PALLADIUM; PHYTOLACCA A
MERICANA ROOT; SILVER; SODIUM FLUORIDE; STILLINGIA SYLVATICA ROOT; SUS SCROFA BO
NE MARROW; SUS SCROFA LYMPH; SUS SCROFA THYMUS; THYROID, PORCINE; TIN; TITANIUM;
TRIFOLIUM PRATENSE FLOWER; ZINC" 3; 3; 12; 12; 12; 12; 3; 200; 12; 12; 12
; 12; 12; 3; 12; 12; 3; 8; 8; 8; 8; 12; 12; 3; 12 [hp_X]/mL; [hp_X]/mL; [h
[hp_X]/mL
57520-0080_3dd132e1-cb3b-4df3-97d3-8a49848e89fe 57520-0080 HUMAN OTC DRUG
Depressoforce Depressoforce LIQUID ORAL 20100210
UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; GOLD;
NITRIC ACID; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE; STRY
CHNOS IGNATII SEED; TRINITROPHENOL 30; 30; 30; 30; 30; 30; 30; 12 [hp_X]/m
L; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0081_b5372a70-02e6-4dfa-9d12-2d313eea52bb 57520-0081 HUMAN OTC DRUG
Drainage Drainage LIQUID ORAL 20100211
UNAPPROVED HOMEOPATHIC Apotheca Company CALCIUM IODIDE; ECHINACE
A ANGUSTIFOLIA; NITRIC ACID; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; POTASSI
UM CHLORIDE; RED CLOVER; SULFUR IODIDE 12; 3; 12; 12; 3; 12; 3; 12 [hp_X]/m
L; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; kg/mL; [hp_X]/mL; [hp_X]/mL
57520-0083_13eb520c-85f6-489a-a505-c8940d3a34b6 57520-0083 HUMAN OTC DRUG
Diabenex HP "Colchicum autumnale, Lacticum acidum, Lycopodium clavat
um, Phosphoricum acidum, Phosphorus, Syzygium jambolanum, Uranium Nitricum,"
Company "COLCHICUM AUTUMNALE BULB; LACTIC ACID, DL-; LYCOPODIUM CLAVATUM
SPORE; PHOSPHORIC ACID; PHOSPHORUS; SYZYGIUM CUMINI SEED; URANYL NITRATE HEXAHY
DRATE" 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/
57520-0084_154a2e0c-332a-426e-9e3a-41983e594853 57520-0084 HUMAN OTC DRUG
Diathesis IV "Fel Tauri, Ginkgo biloba, Kidney, Germanium sesquioxide
, Argentum metallicum, Cuprum metallicum," LIQUID ORAL 20100211
20141230 UNAPPROVED HOMEOPATHIC Apotheca Company .ALPHA.-
KETOGLUTARIC ACID; BOS TAURUS BILE; COPPER; CYSTEINE; FUMARIC ACID; GERMANIUM SE
SQUIOXIDE; GINKGO; GOLD; MANGANESE GLUCONATE; MERCURIUS SOLUBILIS; PHOSPHORIC AC
ID; PORK KIDNEY; SILVER; SODIUM OXALATE; STRYCHNOS NUX-VOMICA SEED 12; 30;
9; 12; 12; 8; 6; 12; 12; 12; 12; 30; 9; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL;
p_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0085_047a4491-0e18-4f80-a6ed-2754ca6d4ae4 57520-0085 HUMAN OTC DRUG
Diathesis "Pancreas, Spleen, Stomach, Ginkgo biloba, Germanium ses
quioxide, Cuprum metallicum" LIQUID ORAL 20100212 UNAPPROV
ED HOMEOPATHIC Apotheca Company .ALPHA.-KETOGLUTARIC ACID; BIS(C
ARBOXYETHYL)GERMANIUM SESQUIOXIDE; COPPER; CYSTEINE; FUMARIC ACID; GINKGO; MANGA
NESE GLUCONATE; SODIUM DIETHYL OXALACETATE; SUS SCROFA PANCREAS; SUS SCROFA SPLE
EN; SUS SCROFA STOMACH; ZINC 12; 8; 9; 9; 12; 6; 10; 12; 30; 30; 30; 9
_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0088_91d78c17-bd3f-4a63-a69d-9b5a46f604fa 57520-0088 HUMAN OTC DRUG
Ear Ear LIQUID ORAL 20100215 UNAPPROVED HOMEO
PATHIC Apotheca Company BAPTISIA TINCTORIA ROOT; CHILI PEPPER; E
CHINACEA; FERRUM PHOSPHORICUM; GOLDENSEAL; MATRICARIA RECUTITA; PHYTOLACCA AMERI
CANA ROOT; PLANTAGO MAJOR; POTASSIUM CHLORIDE; PULSATILLA VULGARIS 3; 12; 3
; 12; 3; 12; 3; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_
57520-0089_a7d61d17-d2af-47bb-88ba-673ace756af2 57520-0089 HUMAN OTC DRUG
Eczema "Arsenicum album, Calcarea carbonica, Graphites" LIQUID
"ARSENIC TRIOXIDE; DAPHNE MEZEREUM BARK; GRAPHITE; MERCURIUS SOLUBILIS; OYSTER S
HELL CALCIUM CARBONATE, CRUDE; SEPIA OFFICINALIS JUICE; SULFUR; TOXICODENDRON PU
BESCENS LEAF" 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL;
57520-0090_f0ae81c6-393e-4fdd-b33b-87c17f0edbbc 57520-0090 HUMAN OTC DRUG
Eczemaforce "Lappa major, Phytolacca decandra, Trifolium pratense"
Company ARCTIUM LAPPA ROOT; ARSENIC TRIOXIDE; CENTELLA ASIATICA; DAPHNE
MEZEREUM BARK; GRAPHITE; PHYTOLACCA AMERICANA ROOT; RED CLOVER 3; 12; 6; 12; 12
; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]
/mL
57520-0091_dc083c3b-7f12-4c7c-85be-84cd7b2b6a05 57520-0091 HUMAN OTC DRUG
Edema-HP Edema-HP LIQUID ORAL 20100215
UNAPPROVED HOMEOPATHIC Apotheca Company APIS MELLIFERA; ARSENIC
TRIOXIDE; DIGITALIS; IRON; LYCOPODIUM CLAVATUM SPORE; SAMBUCUS NIGRA FLOWERING T
OP; STROPHANTHUS HISPIDUS SEED; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30;
; [hp_X]/mL; [hp_X]/mL
57520-0092_3e601df3-668a-453b-b23c-6ba10bfacd57 57520-0092 HUMAN OTC DRUG
Endocrine Balancer Endocrine Balancer LIQUID ORAL 20100215
UNAPPROVED HOMEOPATHIC Apotheca Company FUCUS VESICULOSUS; GLYCY
RRHIZA GLABRA; IODINE; PINUS SYLVESTRIS TOP; SARSAPARILLA; SUS SCROFA ADRENAL GL
AND; THYROID 3; 3; 12; 6; 3; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/
57520-0094_41eb24a4-37a4-4826-a595-540a4cf7d562 57520-0094 HUMAN OTC DRUG
Estrogen "Folliculinum, Oophorinum," LIQUID ORAL 20100216
UNAPPROVED HOMEOPATHIC Apotheca Company ESTRONE; SUS SCROFA OVAR
Y 30; 30 [hp_C]/mL; [hp_C]/mL
57520-0095_dfd902c7-7bdc-467e-959d-02122ed60c15 57520-0095 HUMAN OTC DRUG
Evtox "Cochlearia officinalis, Echinacea angustifolia, Hydrastis canad
ensis, Lomatium, Tabebuia impetiginosa, Propolis, Glandula suprarenalis, Thymus,
Aranea diadema," LIQUID ORAL 20100217 UNAPPROVED HOMEO
PATHIC Apotheca Company ARANEUS DIADEMATUS; COCHLEARIA OFFICINAL
IS FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; HUMAN HERPESVIRUS 4; HUMAN
HERPESVIRUS 4; HUMAN HERPESVIRUS 4; HYDROCHLORIC ACID; IPECAC; LOMATIUM DISSECT
UM ROOT; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; PROPOLIS WAX; SILICON DIOXIDE;
SUS SCROFA ADRENAL GLAND; TABEBUIA IMPETIGINOSA BARK; THYMUS; TOXICODENDRON PUBE
SCENS LEAF 12; 3; 3; 3; 200; 30; 60; 12; 12; 3; 12; 12; 6; 12; 8; 3; 8; 12
57520-0096_803e6900-89af-43cd-90e3-4f8e81681589 57520-0096 HUMAN OTC DRUG
Female Balance Female Balance SPRAY ORAL 20100217
UNAPPROVED HOMEOPATHIC Apotheca Company ESTRONE; PROGESTERONE
6; 6 [iU]/mL; [hp_X]/mL
57520-0097_7e53539e-a4fc-4faf-9bb6-27e703274439 57520-0097 HUMAN OTC DRUG
Flu Tonic "Echinacea angustifolia, Uva-ursi, Baptisia tinctoria, C
onvallaria majalis, Kali muriaticum, Pinus sylvestris, Thuja occidentalis, Bryon
ia alba," LIQUID ORAL 20100217 UNAPPROVED HOMEOPATHIC
Apotheca Company ARCTOSTAPHYLOS UVA-URSI LEAF; BAPTISIA TINCTORIA ROOT; B
RYONIA ALBA ROOT; CONVALLARIA MAJALIS; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINAC
EA ANGUSTIFOLIA; GINKGO; LACHESIS MUTA VENOM; MARSDENIA CONDURANGO BARK; PINUS S
YLVESTRIS LEAFY TWIG; POTASSIUM CHLORIDE; SELENIUM; TABEBUIA IMPETIGINOSA BARK;
THUJA OCCIDENTALIS LEAFY TWIG; VISCUM ALBUM FRUIT 1; 3; 12; 6; 12; 1; 12;
57520-0098_fa005acf-20d5-40a7-b631-72611324d9cd 57520-0098 HUMAN OTC DRUG
FNG I "Echinacea angustifolia, Hydrastis canadensis, Lapachoplex, Loma
tium, Nasturtium aquaticum, Propoloplex, Tabebuia impetiginosa," LIQUID
ALTERNARIA ALTERNATA; ASPERGILLUS NIGER VAR. NIGER; ASTRAGALUS PROPINQUUS ROOT;
AUREOBASIDIUM PULLULANS VAR. PULLUTANS; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS;
ECHINACEA ANGUSTIFOLIA; GINKGO; GOLDENSEAL; LIGUSTICUM PORTERI ROOT; LOMATIUM DI
SSECTUM ROOT; LYCOPODIUM CLAVATUM SPORE; MARSDENIA CONDURANGO BARK; MUCOR RACEMO
SUS; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; PROPOLIS WAX; RHIZOPUS STOLONIF
ER; RORIPPA NASTURTIUM-AQUATICUM; SACCHAROMYCES CEREVISIAE; SEPIA OFFICINALIS JU
ICE; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA ADRENAL GLAND; SUS SCROFA THYMUS; TAB
EBUIA IMPETIGINOSA BARK 200; 200; 3; 200; 200; 200; 3; 3; 3; 3; 3; 12; 3; 200; 1
p_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0099_ea9ae9cb-e8f8-4423-89b4-6f1abb867000 57520-0099 HUMAN OTC DRUG
FNG II "Echinacea angustifolia, Hydrastis canadensis, Lomatium, Nasturt
ium aquaticum, Tabebuia impetiginosa, Iodium, Adrenalinum, Argentum metallicum"
Company CANDIDA ALBICANS; ECHINACEA ANGUSTIFOLIA; EPINEPHRINE; GOLDENSEA
L; IODINE; LOMATIUM; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PULSATILLA VULG
ARIS; RORIPPA NASTURTIUM-AQUATICUM; SEPIA OFFICINALIS JUICE; SILVER; SUS SCROFA
THYMUS; TABEBUIA IMPETIGINOSA BARK; THYROID 30; 3; 8; 3; 6; 3; 30; 12; 30; 3
; 30; 8; 8; 3; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [
57520-0100_803494cd-cde6-4710-a4e0-df6b3430c76a 57520-0100 HUMAN OTC DRUG
GABA "Gaba," LIQUID ORAL 20100217 UNAPPROVED HOMEO
PATHIC Apotheca Company .GAMMA.-AMINOBUTYRIC ACID 30
[hp_C]/mL
57520-0102_b7fd9416-b905-455d-b422-b2448c888335 57520-0102 HUMAN OTC DRUG
Grippe-HP Grippe-HP LIQUID ORAL 20100218
UNAPPROVED HOMEOPATHIC Apotheca Company ACONITUM NAPELLUS; ARSEN
IC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWER
ING TOP; FERRUM PHOSPHORICUM; GELSEMIUM SEMPERVIRENS ROOT 30; 30; 30; 30;
; [hp_X]/mL
57520-0103_58a3cc7b-c517-4fea-997c-bdf8cc4e90f4 57520-0103 HUMAN OTC DRUG
Gynetox "Angelica archangelica, Cimicifuga racemosa, Zincum gluconicum,
Funiculus umbilicalis suis, Lymph node, Oophorinum, Uterus, Glandula suprarenali
s, Thyroidinum," LIQUID ORAL 20100218 UNAPPROVED HOMEO
PATHIC Apotheca Company "ANGELICA ARCHANGELICA ROOT; BLACK COHOS
H; BORIC ACID; CANDIDA ALBICANS; HUMAN HERPESVIRUS 1; HUMAN HERPESVIRUS 2; HUMAN
PAPILLOMAVIRUS; MERCURIUS SOLUBILIS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHO
SPHORUS; PULSATILLA VULGARIS; SAVIN; SEPIA OFFICINALIS JUICE; SUS SCROFA ADRENAL
GLAND; SUS SCROFA LYMPH; SUS SCROFA OVARY; SUS SCROFA UMBILICAL CORD; SUS SCROF
A UTERUS; THYROID; WOOD CREOSOTE; ZINC GLUCONATE" 3; 3; 12; 60; 60; 60; 60
; 12; 30; 30; 12; 30; 12; 9; 8; 8; 8; 8; 9; 12; 6 [hp_X]/mL; [hp_X]/mL; [h
L; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0104_e4aac6c6-7441-4995-bbd7-d076073eb31d 57520-0104 HUMAN OTC DRUG
Gynobalance Gynobalance SPRAY ORAL 20100218
UNAPPROVED HOMEOPATHIC Apotheca Company ESTRADIOL; PRASTERONE; P
REGNENOLONE; PROGESTERONE; TESTOSTERONE 8; 6; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [h
57520-0105_7a6ab07a-8069-41b0-a166-07acdb39cc0a 57520-0105 HUMAN OTC DRUG
HA HP "Belladonna, Bryonia alba, Gelsemium sempervirens, Glonoinum, Me
lilotus officinalis," LIQUID ORAL 20100218 UNAPPROVED HOMEO
PATHIC Apotheca Company ATROPA BELLADONNA; BRYONIA ALBA ROOT; GE
LSEMIUM SEMPERVIRENS ROOT; MELILOTUS OFFICINALIS POLLEN; NITROGLYCERIN; SILICON
DIOXIDE; SODIUM CHLORIDE; SPIGELIA; STRYCHNOS NUX-VOMICA SEED 30; 30; 30; 30;
57520-0106_7baecb66-b21c-42a1-ae8b-4c45820cc689 57520-0106 HUMAN OTC DRUG
Flu-Cold Flu-Cold LIQUID ORAL 20100218
UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; BAPTIS
IA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM FLOWERING TOP;
GELSEMIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; RANCID BEEF
; TOXICODENDRON PUBESCENS LEAF 12; 12; 3; 12; 12; 12; 12; 30; 30 [hp_X]/m
L; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; kg/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_
X]/mL
57520-0107_136ff027-de7c-4bb1-8b04-0ffee6f80bb3 57520-0107 HUMAN OTC DRUG
Hayfever Tonic "Echinacea purpurea, Hydrastis canadensis, Eupatorium pe
rfoliatum, Verbascum thapsus, Ailanthus glandulosus, Allium cepa, Ambrosia artem
isiaefolia, Aurum muriaticum," LIQUID ORAL 20100218 UNAPPROV
ED HOMEOPATHIC Apotheca Company ACER NEGUNDO POLLEN; AGROSTIS GI
GANTEA POLLEN; AILANTHUS ALTISSIMA FLOWERING TWIG; ALFALFA; AMBROSIA ACANTHICARP
A POLLEN; AMBROSIA ARTEMISIIFOLIA; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFID
A POLLEN; BETULA OCCIDENTALIS POLLEN; CAMPHOR (NATURAL); CARYA TOMENTOSA POLLEN;
DACTYLIS GLOMERATA POLLEN; ECHINACEA PURPUREA; ELM; EUPATORIUM PERFOLIATUM FLOW
ERING TOP; FAGUS GRANDIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; GOLD TRICHLORIDE
; GOLDENSEAL; IPECAC; JUGLANS NIGRA POLLEN; ONION; PHLEUM PRATENSE POLLEN; PLATA
NUS OCCIDENTALIS POLLEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; POTASSI
UM DICHROMATE; QUERCUS RUBRA POLLEN; RED CLOVER; RUMEX ACETOSELLA POLLEN; RUMEX
CRISPUS TOP; SALIX NIGRA POLLEN; SOLIDAGO VIRGAUREA FLOWERING TOP; SOLIDAGO VIRG
AUREA POLLEN; VERBASCUM THAPSUS 30; 30; 12; 30; 30; 12; 30; 30; 30; 12; 30; 30;
3; 30; 12; 30; 30; 12; 3; 12; 30; 12; 30; 30; 30; 30; 12; 30; 30; 30; 30; 30; 12
/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [iU]/mL; [hp_X]/mL; [hp_X]/mL;
/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0108_e0bc2d56-7e9a-4a95-b247-3210f82f4c47 57520-0108 HUMAN OTC DRUG
Hemoforce "Urtica urens, Ferrum muriaticum, Aranea diadema, Aurum
metallicum, Cinchona officinalis, Cobaltum gluconate, Phosphorus," LIQUID
ARANEUS DIADEMATUS; CINCHONA OFFICINALIS BARK; COBALTOUS GLUCONATE; FERRIC CHLOR
IDE HEXAHYDRATE; GOLD; PHOSPHORUS; URTICA URENS 12; 12; 12; 6; 12; 12; 3
57520-0109_68df356d-b78e-464a-9c6c-bed347646d17 57520-0109 HUMAN OTC DRUG
Hepataforce "Carduus marianus, Chelidonium majus, Taraxacum officina
le, Lycopodium clavatum, Magnesia phosphorica, Natrum sulphuricum," LIQUID
"CHELIDONIUM MAJUS; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBASIC TRIH
YDRATE; SILYBUM MARIANUM SEED; SODIUM SULFATE; TARAXACUM OFFICINALE" 3; 12; 1
57520-0110_0d387ed4-d6ed-4c09-90c9-e1d750ef99ba 57520-0110 HUMAN OTC DRUG
Hepataplex Hepataplex LIQUID ORAL 20100219
UNAPPROVED HOMEOPATHIC Apotheca Company BETA VULGARIS; CHELIDONI
UM MAJUS; GLUTATHIONE; LYCOPODIUM CLAVATUM SPORE; PETROSELINUM CRISPUM; PEUMUS B
OLDUS LEAF; PHOSPHORUS; PORK LIVER; SILYBUM MARIANUM SEED; STRYCHNOS NUX-VOMICA
SEED; TARAXACUM OFFICINALE 3; 3; 6; 12; 3; 3; 12; 6; 3; 12; 3 [hp_X]/m
[iU]/mL; [hp_X]/mL; [hp_X]/mL
57520-0111_7d0e258f-0f4c-4c0f-84c5-fddd13c91597 57520-0111 HUMAN OTC DRUG
Hepatatox "Triticum aestivum, Chelidonium majus, Taraxacum officin
ale, Glutathione, Hepar bovinum," LIQUID ORAL 20100219
UNAPPROVED HOMEOPATHIC Apotheca Company "ACETIC ACID; BEEF LIVER
; BENZOIC ACID; BENZYL ALCOHOL; BORIC ACID; CHELIDONIUM MAJUS; CHLORINE; CORTICO
TROPIN; CORTISONE ACETATE; ESTRONE; EUGENOL; GLUTATHIONE; ISOPROPYL PALMITATE; L
ACTIC ACID, DL-; LEAD; LYCOPODIUM CLAVATUM SPORE; PETROLATUM; PHENYLBUTAZONE; PH
OSPHORIC ACID; POTASSIUM SORBATE; RESORCINOL; SALICYLIC ACID; SORBITOL; STEARYL
ALCOHOL; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; THYROID; TRITICUM AEST
IVUM POLLEN; XYLITOL" 200; 8; 200; 200; 200; 3; 200; 200; 200; 200; 200; 6; 20
0; 200; 200; 12; 200; 200; 12; 200; 200; 200; 200; 200; 12; 3; 8; 1; 200
_X]/mL; [hp_X]/mL; [hp_X]/mL; [iU]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/m
57520-0112_77bceb5a-7023-44ec-b751-f67ddc218bc4 57520-0112 HUMAN OTC DRUG
Histamine Histaminum hydrochloricum LIQUID ORAL 20100219
UNAPPROVED HOMEOPATHIC Apotheca Company HISTAMINE DIHYDROCHLORID
E 30 [hp_C]/mL
57520-0114_7a0330cd-97f2-4eb3-ae14-06350a86ab43 57520-0114 HUMAN OTC DRUG
Hydrate I "Coffea tosta, Ginkgo biloba, Germanium sesquioxide, Silicea,"
Company COFFEE BEAN; GERMANIUM SESQUIOXIDE; GINKGO; SILICON DIOXIDE
1; 8; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0115_46fc331a-bdef-4dbb-a6a7-97ee81717dfb 57520-0115 HUMAN OTC DRUG
Hydrate II "Coffea tosta, Avena sativa, Equisetum hyemale, Hypericum perfor
atum, Ginkgo biloba, Germanium sesquioxide, Silicea," LIQUID ORAL 20100222
UNAPPROVED HOMEOPATHIC Apotheca Company AVENA SATIVA FLOWERING T
OP; COFFEE BEAN; EQUISETUM HYEMALE; GERMANIUM SESQUIOXIDE; GINKGO; HYPERICUM PER
FORATUM; SILICON DIOXIDE 3; 1; 3; 8; 6; 3; 8 [hp_X]/mL; [hp_X]/mL; [h
57520-0117_61ac297c-4a70-4b84-9a57-eefd6bc3bfcf 57520-0117 HUMAN OTC DRUG
Hypopituitaryplex "Aralia quinquefolia, Hydrocotyle asiatica, Poly
gonum multiflorum, Hypothalamus, Pituitarum posterium, Germanium sesquioxide, Pi
neal," LIQUID ORAL 20100222 UNAPPROVED HOMEOPATHIC
Apotheca Company AMERICAN GINSENG; CENTELLA ASIATICA; FALLOPIA MULTIFLORA
ROOT; GERMANIUM SESQUIOXIDE; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PINEAL GLAND;
SUS SCROFA PITUITARY GLAND 3; 3; 3; 12; 8; 12; 8 [hp_X]/mL; [hp_X]/mL; [h
57520-0119_845b8959-4553-4e54-939f-e27a228c7075 57520-0119 HUMAN OTC DRUG
HZ Formula "Baptisia tinctoria, Echinacea angustifolia, Lomatium, T
abebuia impetiginosa, Propolis, Spleen, Thymus, Thyrodinum," LIQUID ORAL
BAPTISIA TINCTORIA ROOT; CANDIDA ALBICANS; CHLAMYDIA TRACHOMATIS; ECHINACEA ANGU
STIFOLIA; GELSEMIUM SEMPERVIRENS ROOT; HUMAN HERPESVIRUS 1; HUMAN HERPESVIRUS 2;
HUMAN PAPILLOMAVIRUS; LOMATIUM DISSECTUM ROOT; LYCOPODIUM CLAVATUM SPORE; PROPO
LIS WAX; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA SPLEEN; TABEBUIA IMPETIGINOSA BAR
K; THYMUS; THYROID; TRICHINELLA SPIRALIS 3; 200; 200; 3; 12; 200; 200; 20
[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0120_ab616edf-5203-4e4a-b2c6-4ce329c35f69 57520-0120 HUMAN OTC DRUG
Immune Forte "Dehydro-epi-androsterone(DHEA), Estradiol, Pituitarum p
osterium, Pregnenolone, Progesterone, Spleen, Testosterone," SPRAY ORAL
ESTRADIOL; PRASTERONE; PREGNENOLONE; PROGESTERONE; SUS SCROFA PITUITARY GLAND; S
US SCROFA SPLEEN; TESTOSTERONE; THYMUS; THYROID 8; 8; 8; 8; 8; 8; 8; 8; 12
_X]/mL; [hp_X]/mL
57520-0123_a927b613-1661-4f28-afc4-846b9a44b539 57520-0123 HUMAN OTC DRUG
Inflammation II "Astragalus membranaceus, Echinacea angustifolia"
Company ASTRAGALUS PROPINQUUS ROOT; CARBO ANIMALIS; CAUSTICUM; ECHINACEA
ANGUSTIFOLIA; GELSEMIUM SEMPERVIRENS ROOT; GOLD; GOLDENSEAL; PHOSPHORUS; SARSAP
ARILLA; SODIUM SULFATE; SULFUR; TABEBUIA IMPETIGINOSA BARK; THUJA OCCIDENTALIS T
WIG; THYROID 3; 12; 12; 3; 30; 12; 3; 30; 3; 30; 30; 3; 30; 8 [hp_X]/m
57520-0128_0daf352e-d341-48a8-9bd8-3f1d9747e5e7 57520-0128 HUMAN OTC DRUG
Intestaforce Intestaforce LIQUID ORAL 20100323
UNAPPROVED HOMEOPATHIC Apotheca Company "ALTHAEA OFFICINALIS ROO
T; CHILI PEPPER; COMFREY ROOT; FENNEL SEED; FERRUM PHOSPHORICUM; MAGNESIUM PHOSP
HATE, DIBASIC TRIHYDRATE; MERCURIUS SOLUBILIS; SILVER NITRATE" 3; 3; 3; 3; 12;
57520-0129_bbb69317-09c5-4744-8358-2c03ceab0ae1 57520-0129 HUMAN OTC DRUG
Teething "Arnica Montana, Trifolium pratense, Calcarea carbonica,
Calcarea fluorica, Calcarea phosphorica, Chamomilla, Kreosotum, Silicea,"
Company "ARNICA MONTANA; CALCIUM FLUORIDE; MATRICARIA RECUTITA; OYSTER S
HELL CALCIUM CARBONATE, CRUDE; RED CLOVER; SILICON DIOXIDE; TRIBASIC CALCIUM PHO
SPHATE; WOOD CREOSOTE" 3; 12; 12; 12; 3; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [h
p_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0130_65e6129f-68f4-4b39-b8fa-4d22736ad970 57520-0130 HUMAN OTC DRUG
Bio Rock Rose "Rock rose," LIQUID ORAL 20100305
UNAPPROVED HOMEOPATHIC Apotheca Company HELIANTHEMUM NUMMULARIUM
FLOWER 200 [hp_C]/mL
57520-0131_f62cc8bc-10b9-4c63-8831-6ae27211befb 57520-0131 HUMAN OTC DRUG
Pneumo HP "Ammonium muriaticum, Antimonium tartaricum, Arsenicum album, Ca
lcarea Carbonica, Lobelia inflata, Natrum sulphuricum, Spongia tosta, Phosphorus
Apotheca Company "AMMONIUM CHLORIDE; ANTIMONY POTASSIUM TARTRATE; ARSENIC
TRIOXIDE; LOBELIA INFLATA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; S
ODIUM SULFATE; SPONGIA OFFICINALIS SKELETON, ROASTED" 30; 30; 30; 30; 30; 30;
30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]
/mL; [hp_X]/mL
57520-0133_c0e34435-7ef4-409a-897a-076f81d44240 57520-0133 HUMAN OTC DRUG
Sinus Clear "Hepar sulphuris calcareum, Kali bichromicum, Pulsatilla
, Silicea," CAPSULE ORAL 20101108 UNAPPROVED HOMEOPATHIC
Apotheca Company CALCIUM SULFIDE; POTASSIUM DICHROMATE; PULSATILLA VULGAR
IS; SILICON DIOXIDE 10; 10; 10; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
57520-0134_67f2d48b-e402-4b46-83b0-9b17574f7478 57520-0134 HUMAN OTC DRUG
Sinus Clear "Hepar sulphuris calcareum, Kali bichromicum, Pulsatilla
, Silicea," CAPSULE ORAL 20101104 UNAPPROVED HOMEOPATHIC
Apotheca Company CALCIUM SULFIDE; POTASSIUM DICHROMATE; PULSATILLA VULGAR
IS; SILICON DIOXIDE 10; 10; 10; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
57520-0136_713ba513-6b9e-47ad-99d4-938ca90edccc 57520-0136 HUMAN OTC DRUG
LGB HP "Chelidonium majus, Lycopodium clavatum, Nux vomica, Phosphorus,
Natrum sulphuricum, colocynthis, veratrum album," LIQUID ORAL 20100721
UNAPPROVED HOMEOPATHIC Apotheca Company ATROPA BELLADONNA; CHELI
DONIUM MAJUS; CITRULLUS COLOCYNTHIS FRUIT PULP; LYCOPODIUM CLAVATUM SPORE; PHOSP
HORUS; PULSATILLA VULGARIS; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; VERATRUM
ALBUM ROOT 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [h
57520-0137_17964fbb-a157-45ba-96f0-15f7b7b5af6a 57520-0137 HUMAN OTC DRUG
Healing Support "Betula pendula cortex, Caltha palustris, Galium aparine
, Sedum acre, Thuja occidentalis, Urtica urens," LIQUID ORAL 20100315
20160207 UNAPPROVED HOMEOPATHIC Apotheca Company APIS MEL
LIFERA; BETULA PENDULA BARK; CALCIUM FLUORIDE; CALTHA PALUSTRIS; CLEMATIS RECTA
FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; GALIUM APARINE; HEDERA HELIX FLOWERING TW
IG; JUNIPER; NITRIC ACID; ONONIS CAMPESTRIS; PHOSPHORUS; QUILLAJA SAPONARIA BARK
; RANCID BEEF; SEDUM ACRE; SEMPERVIVUM TECTORUM LEAF; SILVER; THUJA OCCIDENTALIS
LEAFY TWIG; URTICA URENS 12; 2; 8; 3; 4; 5; 3; 4; 4; 6; 4; 8; 4; 12; 3; 4
; 8; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0138_d92c3601-1c0d-44d8-ac1e-0bac54c5a579 57520-0138 HUMAN OTC DRUG
Optimal HCG "Fucus vesiculosus, Cyanocobalamin, Glandula suprarenali
s suis, Hepar suis, L-carnitine, Ornithine, Antimonium crudum," LIQUID ORAL
"ANTIMONY TRISULFIDE; CYANOCOBALAMIN; FUCUS VESICULOSUS; HUMAN CHORIONIC GONADOT
ROPIN; LEVOCARNITINE; ORNITHINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PANCRELI
PASE; PORK LIVER; SODIUM SULFATE; SUS SCROFA ADRENAL GLAND; SUS SCROFA HYPOTHALA
MUS; SUS SCROFA THYROID" 8; 6; 2; 60; 30; 30; 12; 12; 6; 10; 6; 18; 8
_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0139_26b7a34d-bbaa-4938-8737-c7bab1b3de6f 57520-0139 HUMAN OTC DRUG
Arthritis HP "Apis mellifica, Bryonia alba, Causticum, Colchicum autu
mnale, Kalmia latifolia, Ledum palustre" LIQUID ORAL 20100805
UNAPPROVED HOMEOPATHIC Apotheca Company APIS MELLIFERA; BRYONIA
ALBA ROOT; CAUSTICUM; COLCHICUM AUTUMNALE BULB; KALMIA LATIFOLIA LEAF; LEDUM PAL
USTRE TWIG; PULSATILLA VULGARIS; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCE
NS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL;
57520-0140_417028ec-c6d9-4b96-a1d1-228c99671afc 57520-0140 HUMAN OTC DRUG
Total Body Detox "Citrus limonum, Taraxacum officinale, Uva-ursi,
Berberis vulgaris, Capsicum annuum, Galium aparine, Lobelia inflata, Nux vomica
, Schisandra, Tylophora, Brain, Cor suis, Glandula suprarenalis suis," LIQUID
"ARCTOSTAPHYLOS UVA-URSI LEAF; BERBERIS VULGARIS FRUIT; CALCIUM SULFIDE; CAPSICU
M; GALIUM APARINE; LACTIC ACID, DL-; LEMON JUICE; LOBELIA INFLATA; MAGNESIUM PHO
SPHATE, DIBASIC TRIHYDRATE; PORK BRAIN; PORK HEART; PORK INTESTINE; PORK KIDNEY;
PORK LIVER; SCHISANDRA CHINENSIS FRUIT; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA A
DRENAL GLAND; SUS SCROFA LUNG; SUS SCROFA LYMPH; SUS SCROFA SPLEEN; TARAXACUM OF
FICINALE; THYROID; TYLOPHORA INDICA ROOT" 2; 3; 8; 3; 3; 8; 1; 3; 8; 8; 8;
57520-0141_cc043629-0e88-4df1-b0d5-365649b43ace 57520-0141 HUMAN OTC DRUG
Thyro T3 Rescue "Spongia tosta, Iodium Fucus vesiculosus, Belladonna, Ad
enosine triphosphate, Parathyroid," LIQUID ORAL 20100312
UNAPPROVED HOMEOPATHIC Apotheca Company "ADENOSINE TRIPHOSPHATE;
ATROPA BELLADONNA; BEEF LIVER; FUCUS VESICULOSUS; IODINE; LEVOTHYROXINE; LIOTHY
RONINE; PORK KIDNEY; SELENIUM; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA
HYPOTHALAMUS; SUS SCROFA PARATHYROID GLAND; SUS SCROFA PITUITARY GLAND; SUS SCR
OFA THYMUS; THYROID" 3; 200; 30; 1; 1; 3; 3; 30; 8; 6; 30; 8; 30; 30; 1
[hp_Q]/mL; [hp_X]/mL; [hp_X]/mL; [hp_Q]/mL; [hp_Q]/mL; [hp_Q]/mL; [hp_Q]/mL; [hp
_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_Q]
/mL
57520-0143_02d86a85-bd06-4f30-b0f4-76b3f68f5af2 57520-0143 HUMAN OTC DRUG
Endopure Testos-Male "DNA, RNA, Cortisol, Glandula suprarenalis, Hypo
thalamus, Pitrutary, Prostate, Testosterone," LIQUID ORAL 20100402
UNAPPROVED HOMEOPATHIC Apotheca Company CHELIDONIUM MAJUS; HERRI
NG SPERM DNA; HYDROCORTISONE; SACCHAROMYCES CEREVISIAE RNA; SAW PALMETTO; SUS SC
ROFA ADRENAL GLAND; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PITUITARY GLAND; SUS SCR
OFA PROSTATE; TESTOSTERONE; THUJA OCCIDENTALIS LEAFY TWIG 12; 6; 6; 6; 12;
6; 6; 6; 6; 12; 30 [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [
hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL
57520-0148_e5a18936-eb3d-409f-b00d-1a22396bbe47 57520-0148 HUMAN OTC DRUG
Inflammation I Inflammation I LIQUID ORAL 20100309
UNAPPROVED HOMEOPATHIC Apotheca Company APIS MELLIFERA; ATROPA B
ELLADONNA; ECHINACEA ANGUSTIFOLIA; FERRUM PHOSPHORICUM; GOLDENSEAL; NERIUM OLEAN
DER LEAF; NITRIC ACID; PHYTOLACCA AMERICANA ROOT; RORIPPA NASTURTIUM-AQUATICUM;
SILICON DIOXIDE 12; 12; 3; 12; 3; 12; 12; 3; 3; 12 [hp_X]/mL; [hp_X]/mL; [h
]/mL
57520-0149_fcd79216-363c-4e46-941a-1860644fb493 57520-0149 HUMAN OTC DRUG
L-Dopa L-dopa LIQUID ORAL 20100317 UNAPPROVED HOMEO
PATHIC Apotheca Company LEVODOPA 30 [hp_C]/mL
57520-0150_8a841ae0-2af9-450c-89b6-8e747d7f358f 57520-0150 HUMAN OTC DRUG
Liver Tonic II "Boldo, Carduus marianus, Curcuma, Echinacea angustifoli
a, Taraxacum officinale, Magnesia phosphorica, Gallbladder," LIQUID ORAL
"AMMI VISNAGA FRUIT; ATROPINE SULFATE; BEEF LIVER; CHELIDONIUM MAJUS; CULVER'S R
OOT; ECHINACEA ANGUSTIFOLIA; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PEUMUS BOL
DUS LEAF; PODOPHYLLUM PELTATUM ROOT; SILYBUM MARIANUM SEED; SUS SCROFA GALLBLADD
ER; TARAXACUM OFFICINALE; TURMERIC; TURMERIC" 12; 12; 200; 12; 12; 1; 8; 1; 12
hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_
X]/mL; [hp_X]/mL
57520-0151_85807442-9511-4e8b-9382-72d592027786 57520-0151 HUMAN OTC DRUG
Lymphoplex "Myrrha, Trigonella foenum-graecum, Pinus sylvestris, Ly
mph, Spleen, Conium maculatum, Echinacea Angustifolia, Hepar sulphuris calcareum
, Hydrangea arborescens, Phytolacca decandra, Silicea," LIQUID ORAL 20100315
UNAPPROVED HOMEOPATHIC Apotheca Company CALCIUM SULFIDE; CONIUM
MACULATUM FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; FENUGREEK SEED; HYDRANGEA; MYRR
H; PHYTOLACCA AMERICANA ROOT; PINUS SYLVESTRIS TOP; SILICON DIOXIDE; SUS SCROFA
LYMPH; SUS SCROFA SPLEEN 12; 12; 12; 3; 12; 3; 12; 6; 12; 8; 8 [hp_X]/m
57520-0152_9132903b-d692-402f-b41d-f2c96d031744 57520-0152 HUMAN OTC DRUG
Apizelen "Alfalfa, Avena sativia, Chelidonium majus, Aralia quinq
uefolia, Beta vulgaris, Calendula officinalis, Cuprum aceticum," LIQUID
ALFALFA; AMERICAN GINSENG; AVENA SATIVA FLOWERING TOP; BETA VULGARIS; CALENDULA
OFFICINALIS FLOWERING TOP; CHELIDONIUM MAJUS; COBALT; COBALTOUS GLUCONATE; COPPE
R GLUCONATE; CUPRIC ACETATE; ECHINACEA; GERMANIUM; GLUTATHIONE; LING; MAGNESIUM
GLUCONATE; OXALIS ACETOSELLA; PHYTOLACCA AMERICANA ROOT; RED CLOVER; SILVER; SOD
IUM CHLORIDE; UBIDECARENONE; URTICA DIOICA; VISCUM ALBUM FRUITING TOP 1; 2; 1;
2; 2; 1; 3; 3; 3; 2; 2; 6; 3; 4; 3; 2; 2; 2; 6; 2; 3; 2; 2 [hp_C]/mL; [hp_C
]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/m
L; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL;
[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL
57520-0154_cccabf04-6888-4c58-98dd-168cbbc0549e 57520-0154 HUMAN OTC DRUG
Iodine Plus Capsule "Thyroidinum, Thyroxine, Trilodothyronine,"
CAPSULE ORAL 20100713 UNAPPROVED HOMEOPATHIC Apotheca
Company LEVOTHYROXINE; LIOTHYRONINE; THYROID 30; 200; 30 [hp_X]/m
g; [hp_C]/mg; [hp_X]/mg
57520-0156_88f3e94a-050b-4897-9a32-8d47d19ccf0e 57520-0156 HUMAN OTC DRUG
Pre Post Surgery HP "Arnica montana, Bellis perennis, Bryonia, Calen
dula officinalis, Hypericum perforatum, Ledum palustre, Phosphorus, Pyrogenium,
Rhus toxicodendron," LIQUID ORAL 20101001 UNAPPROVED HOMEO
PATHIC Apotheca Company ARNICA MONTANA; BELLIS PERENNIS; BRYONIA
ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; DELPHINIUM STAPHI
SAGRIA SEED; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; PHOSPHORUS; RANCID BEEF;
RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF 12; 12; 12; 3; 3
mL
57520-0157_c8b67091-950b-477e-9a6a-268704b521d3 57520-0157 HUMAN OTC DRUG
Sore Throat "Echinacea purpurea, Plantago major, Baptisia tinctoria"
SPRAY ORAL 20100625 UNAPPROVED HOMEOPATHIC Apotheca
Company APIS MELLIFERA; ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; CALC
IUM SULFIDE; ECHINACEA PURPUREA; LACHESIS MUTA VENOM; MERCURIUS SOLUBILIS; PHYTO
LACCA AMERICANA ROOT; PLANTAGO MAJOR 12; 12; 3; 15; 2; 12; 12; 3; 2 [hp_X]/m
[hp_X]/mL
57520-0158_e516926d-01d3-45cc-9977-d031cf4c2279 57520-0158 HUMAN OTC DRUG
Shark Cartilage Shark cartilage LIQUID ORAL 20100714
UNAPPROVED HOMEOPATHIC Apotheca Company SHARK 12 [hp_X]/m
L
57520-0160_db7177c2-aa07-45da-9f7f-208d078d6397 57520-0160 HUMAN OTC DRUG
Inflammation "Mangosteen, Acai, Aronia, Olibanum,, Aconitum napellus,
Bryonia, Humulus lupulus," SPRAY ORAL 20100813 UNAPPROV
ED HOMEOPATHIC Apotheca Company "ACAI; ACONITUM NAPELLUS; APIS M
ELLIFERA; ARNICA MONTANA; BRYONIA ALBA ROOT; FRANKINCENSE; GOLDENSEAL; HOPS; HYP
ERICUM PERFORATUM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; THUJA OCCIDENTALIS L
EAFY TWIG; TOXICODENDRON PUBESCENS LEAF" 3; 6; 200; 200; 6; 3; 6; 6; 200;
8; 200; 200 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL
; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL
57520-0161_ecc48202-a2b1-421b-9de3-92f1b65dfb8c 57520-0161 HUMAN OTC DRUG
homeopathic HCG "Cyanocobalamin, L-carnitine, Ornithine, Human chorionic
gonadotropin," SPRAY ORAL 20100902 UNAPPROVED HOMEOPATHIC
Apotheca Company CYANOCOBALAMIN; HUMAN CHORIONIC GONADOTROPIN; LEVOCARNIT
INE; ORNITHINE 6; 60; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0164_dc25b5ef-d8df-4919-a7d6-e1aa799185e1 57520-0164 HUMAN OTC DRUG
Candida Alb "Candida albicans," LIQUID ORAL 20101008
60 [hp_X]/mL
57520-0166_7686299f-f0fe-4380-9e60-6db57382e74c 57520-0166 HUMAN OTC DRUG
Epstein Barr Virus Remedy Epstein Barr Virus Remedy 200X LIQUID
NOT APPLICABLE 20100319 UNAPPROVED HOMEOPATHIC Apotheca
Company HUMAN HERPESVIRUS 4 200 [hp_X]/mL
57520-0167_3aa0436a-15ca-4667-a5b2-64f9d7d54924 57520-0167 HUMAN OTC DRUG
57520-0168_e64bdacf-5b8a-4676-b489-b0d3e65970aa 57520-0168 HUMAN OTC DRUG
Epstein Barr Virus Remedy Epstein-barr virus LIQUID ORAL
HUMAN HERPESVIRUS 4 60 [hp_X]/mL
57520-0169_ab7b718b-e740-40e9-9ed9-1330d34c0bee 57520-0169 HUMAN OTC DRUG
57520-0170_37c9cbfa-2bec-43cf-a66b-4045c2f0fc91 57520-0170 HUMAN OTC DRUG
Epstein Barr Virus Remedy Epstein-barr virus LIQUID ORAL
HUMAN HERPESVIRUS 4 15 [hp_X]/mL
57520-0171_dce9b120-a707-4698-9937-f062f735ed89 57520-0171 HUMAN OTC DRUG
57520-0174_5d2481d6-62d3-4064-b1b5-e7c431e9f859 57520-0174 HUMAN OTC DRUG
Epstein Barr Virus Remedy Spstein Barr Virus Remedy 6X LIQUID
57520-0175_2d02e16b-07b4-451d-b672-c85ed2a9d3a5 57520-0175 HUMAN OTC DRUG
Virotox "Echinacea angustifolia, Hydrastis canadensis, Lomatium, Myrrha,
Nasturtium aquaticum, Tabebuia impetiginosa, Glandula suprarenalis, Thmus,"
Company ATROPA BELLADONNA; ECHINACEA ANGUSTIFOLIA; GELSEMIUM SEMPERVIREN
S ROOT; GOLDENSEAL; LOMATIUM; LYCOPODIUM CLAVATUM SPORE; MYRRH; RANCID BEEF; ROR
IPPA NASTURTIUM-AQUATICUM; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA ADRENAL GLAND;
SUS SCROFA THYMUS; TABEBUIA IMPETIGINOSA BARK 12; 3; 12; 3; 3; 12; 3; 200; 3;
; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0176_b082f269-441e-438c-8323-2539f25301f9 57520-0176 HUMAN OTC DRUG
Dr Wises Formula II Intestinal Calm "Lycopodium clavatum, Pulsatilla
," CAPSULE ORAL 20101028 UNAPPROVED HOMEOPATHIC
Apotheca Company LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS 12; 12
[hp_X]/1; [hp_X]/1
57520-0177_06d2a31a-197f-45c4-b81e-1d72eece0c05 57520-0177 HUMAN OTC DRUG
Happy Bones "Urtica dioica, Calcarea hypophosphorosa, Mezereum, Natr
um phosphoricum, Symphytum officinale, Calcarea phosphorica, Calcarea fluorica,
Boron, Hekla lava, Vanadium metallicum, Silicea, Calcarea carboni" LIQUID
"BORON; CALCIUM FLUORIDE; CALCIUM HYPOPHOSPHITE; COMFREY ROOT; DAPHNE MEZEREUM B
ARK; HEKLA LAVA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SILICON DIOXIDE; SODIUM
PHOSPHATE, DIBASIC ANHYDROUS; TRIBASIC CALCIUM PHOSPHATE; URTICA DIOICA; VANADIU
M" 12; 30; 6; 30; 6; 12; 30; 30; 6; 8; 4; 12 [hp_X]/mL; [hp_X]/mL; [h
57520-0178_5b42dc2f-1b21-4170-8238-d72eb9839a3b 57520-0178 HUMAN OTC DRUG
Dr Wises Formula Intestinal Calm "Lycopodium clavatum, Pulsatilla
," CAPSULE ORAL 20101022 UNAPPROVED HOMEOPATHIC
Apotheca Company LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS 12; 12
[hp_X]/1; [hp_X]/1
57520-0179_acedc885-0e35-42e7-b466-2a5b177604ab 57520-0179 HUMAN OTC DRUG
Bac HP "Apis mellifica, Arsenicum album, Belladonna, Chamomilla, Echina
cea, Lachesis mutus, Mercurius Solubilis," LIQUID ORAL 20100915
TRIOXIDE; ATROPA BELLADONNA; CHAMOMILE; ECHINACEA; LACHESIS MUTA VENOM; MERCURIU
S SOLUBILIS; PULSATILLA VULGARIS; RANCID BEEF; SILICON DIOXIDE; TOXICODENDRON PU
BESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X
L; [hp_X]/mL; [hp_X]/mL
57520-0181_6c6c255d-ec9c-4376-bc7e-5758004170cf 57520-0181 HUMAN OTC DRUG
HCG Formula "Foeniculum vulgare, Fucus vesiculosus, Lecithin, Ammoni
um carbonicum, Caulophyllum thalictroides, Galium aparine, Lac defloratum, Phosp
horus, Phytolacca decandra, Rubus idaeus, Abrotanum," SPRAY ORAL 20101230
UNAPPROVED HOMEOPATHIC Apotheca Company "AMMONIUM BROMIDE; AMMON
IUM CARBONATE; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; ARTEMISIA ABROTANUM FLOWER
ING TOP; BARIUM CHLORIDE DIHYDRATE; CALCIUM ARSENATE; CAULOPHYLLUM THALICTROIDES
ROOT; CLAVICEPS PURPUREA SCLEROTIUM; FENNEL SEED; FUCUS VESICULOSUS; GALIUM APA
RINE; HELLEBORUS NIGER ROOT; HUMAN CHORIONIC GONADOTROPIN; LECITHIN, SOYBEAN; LY
COPODIUM CLAVATUM SPORE; MANGANESE; NIACINAMIDE; OYSTER SHELL CALCIUM CARBONATE,
CRUDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; RUBUS IDAEUS LEAF; SEMECARPUS ANA
CARDIUM JUICE; SILICON DIOXIDE; SKIM MILK; STRYCHNOS IGNATII SEED; SUS SCROFA TH
YMUS; SUS SCROFA THYROID; TRIBASIC CALCIUM PHOSPHATE" 8; 6; 8; 30; 30; 30; 8;
6; 30; 2; 3; 6; 30; 60; 3; 30; 8; 30; 30; 6; 6; 6; 30; 30; 6; 30; 30; 30; 30
57520-0182_ae784fde-ad2b-4330-9203-81c0cda21880 57520-0182 HUMAN OTC DRUG
Extreme HCG "Fucus vesiculosus, Cyanocobalamin, Glandula suprarenali
s suis, Hepar suis, L-carnitine, Ornithine, Antimonium crudum, hCG, Throidinum,"
Company "ANTIMONY TRISULFIDE; CYANOCOBALAMIN; FUCUS VESICULOSUS; HUMAN C
HORIONIC GONADOTROPIN; LEVOCARNITINE; ORNITHINE; OYSTER SHELL CALCIUM CARBONATE,
CRUDE; PANCRELIPASE; PORK LIVER; SODIUM SULFATE; SUS SCROFA ADRENAL GLAND; SUS
SCROFA HYPOTHALAMUS; SUS SCROFA THYROID" 8; 6; 2; 60; 30; 30; 12; 12; 6;
57520-0183_dd5c51b7-b8aa-49ec-a38c-14d09d98bcc6 57520-0183 HUMAN OTC DRUG
Smart HCG "Human chorionic gonadotropin," LIQUID ORAL 20101005
UNAPPROVED HOMEOPATHIC Apotheca Company HUMAN CHORIONIC GONADOTR
OPIN 60 [hp_X]/mL
57520-0186_6ffa93fa-d04c-4d10-8677-d00374e0558e 57520-0186 HUMAN OTC DRUG
Bio Scleranthus "Scleranthus," LIQUID ORAL 20100317
UNAPPROVED HOMEOPATHIC Apotheca Company SCLERANTHUS ANNUUS FLOWE
RING TOP 200 [hp_C]/mL
57520-0190_2cda9d1f-61be-45c8-acf1-87e0d436cfdd 57520-0190 HUMAN OTC DRUG
StaLean "L-carnitine tartrate, L-isoleucine, L-leucine, L-valine, Magnes
ia phosphorica, Pyridoxine," SPRAY ORAL 20100312 UNAPPROV
ED HOMEOPATHIC Apotheca Company "DOPAMINE; ISOLEUCINE; LEUCINE;
LEVOCARNITINE TARTRATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MERCURIUS SOLUB
ILIS; NERIUM OLEANDER LEAF; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PYRIDOXINE; S
CHOENOCAULON OFFICINALE SEED; SEROTONIN; SILVER; SODIUM SULFATE; SUS SCROFA HYPO
THALAMUS; SUS SCROFA PANCREAS; SUS SCROFA SPLEEN; VALINE" 200; 60; 60; 60;
60; 200; 200; 200; 60; 200; 200; 200; 200; 100; 200; 200; 60 [hp_C]/mL; [hp_X
L; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL;
[hp_X]/mL
57520-0191_97f8d1d1-7719-4147-8b61-e4d2c7d5ee73 57520-0191 HUMAN OTC DRUG
Liquid Detox "Citrus limonum, Taraxacum officinale, Uva-ursi, Berberi
s vulgaris, Capsicum annuum, Galium aparine, Lobelia inflata, Nux vomica, Schisa
ndra, Tylophora asthmatica, Brain, Cor, Glandula suprarenalis sui" LIQUID
"ARCTOSTAPHYLOS UVA-URSI LEAF; BERBERIS VULGARIS ROOT BARK; CALCIUM SULFIDE; CAP
SICUM; GALIUM APARINE; LACTIC ACID, DL-; LEMON JUICE; LOBELIA INFLATA; MAGNESIUM
PHOSPHATE, DIBASIC TRIHYDRATE; PORK BRAIN; PORK HEART; PORK INTESTINE; PORK KID
NEY; PORK LIVER; SCHISANDRA CHINENSIS FRUIT; STRYCHNOS NUX-VOMICA SEED; SUS SCRO
FA ADRENAL GLAND; SUS SCROFA LUNG; SUS SCROFA LYMPH; SUS SCROFA SPLEEN; SUS SCRO
FA THYROID; TARAXACUM OFFICINALE; TYLOPHORA INDICA ROOT" 2; 3; 8; 3; 3; 8
; 1; 3; 8; 8; 8; 8; 8; 8; 3; 3; 8; 8; 8; 8; 8; 2; 3 [hp_X]/mL; [hp_X]/mL; [h
57520-0197_e40940e8-b6c7-4e6b-a89a-41b198a5796e 57520-0197 HUMAN OTC DRUG
Formula 4 "Calendula officinalis, Bellis Perennis, Ledum Palustre,
Arnica Montana, Phosphorus" LIQUID ORAL 20100329 UNAPPROV
ED HOMEOPATHIC Apotheca Company ARNICA MONTANA; BELLIS PERENNIS;
CALENDULA OFFICINALIS FLOWERING TOP; LEDUM PALUSTRE TWIG; PHOSPHORUS 30; 12;
6; 12; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL
57520-0201_41b0cc6a-21e5-4be6-9dec-02aa6a6c5ce2 57520-0201 HUMAN OTC DRUG
Formula 8 "Arnica montana, Bellis perennis, Hypericum perforatum"
Company ARNICA MONTANA; BELLIS PERENNIS; HYPERICUM PERFORATUM; PHOSPHORU
S; TOXICODENDRON PUBESCENS LEAF 6; 6; 12; 30; 30 [hp_C]/mL; [hp_C]/mL; [h
p_C]/mL; [hp_C]/mL; [hp_C]/mL
57520-0203_efb7e1df-1b3f-4acc-9769-553d433c344c 57520-0203 HUMAN OTC DRUG
Formula 10 "Arnica montana, Bellis perennis, Phosphorus," LIQUID
ARNICA MONTANA; BELLIS PERENNIS; DELPHINIUM STAPHISAGRIA SEED; PHOSPHORUS; TOXIC
ODENDRON PUBESCENS LEAF 6; 6; 6; 6; 6 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/
mL; [hp_C]/mL
57520-0204_f3f7373b-aecc-4529-a9fb-508f9409bddd 57520-0204 HUMAN OTC DRUG
MBM 1 Bladder Irritated "Berberis vulgaris, Bladder, Thuja occidentalis,
Bryonia, Hepar sulphuris calcareum," LIQUID ORAL 20100426
UNAPPROVED HOMEOPATHIC Apotheca Company APIS MELLIFERA; BARIUM C
ARBONATE; BERBERIS VULGARIS FRUIT; BRYONIA ALBA ROOT; CALCIUM SULFIDE; DELPHINIU
M STAPHISAGRIA SEED; PULSATILLA VULGARIS; SUS SCROFA URINARY BLADDER; THUJA OCCI
DENTALIS LEAFY TWIG 144; 144; 3; 89; 89; 89; 89; 3; 34 [hp_C]/mL; [hp_C
L
57520-0205_675906ae-4cf1-4a3e-92ac-230ca611b054 57520-0205 HUMAN OTC DRUG
MBM 2 Gallbladder "Fel tauri, Chionanthus virginica, Nux vomica, A
rsenicum album, Platinum metallicum," LIQUID ORAL 20100422
UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; BOS TA
URUS BILE; CHIONANTHUS VIRGINICUS BARK; PLATINUM; STRYCHNOS NUX-VOMICA SEED
233; 3; 34; 233; 34 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL
57520-0206_d4df3d85-618d-46ec-9336-170b1e192b35 57520-0206 HUMAN OTC DRUG
MBM 3 Heart Shock "Phytolacca decandra, Spongia tosta, Crocus sati
vus, Coffea cruda, Aurum metallicum," LIQUID ORAL 20100420
UNAPPROVED HOMEOPATHIC Apotheca Company "ARABICA COFFEE BEAN; GO
LD; PHYTOLACCA AMERICANA ROOT; SAFFRON; SPONGIA OFFICINALIS SKELETON, ROASTED"
89; 144; 3; 34; 3 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL
57520-0209_db719c57-f2a5-40a7-835e-97ef7f6d2c02 57520-0209 HUMAN OTC DRUG
MBM 6 Liver "Chelidonium majus, Liver, Cholesterinum, Lycopodium cla
vatum, Tarentula hispana, Arsenicum album, Belladonna," LIQUID ORAL 20100427
BELLADONNA; CHELIDONIUM MAJUS; CHOLESTEROL; LYCOPODIUM CLAVATUM SPORE; LYCOSA T
ARANTULA; PORK LIVER 233; 233; 3; 34; 144; 233; 3 [hp_C]/mL; [hp_C]/mL; [h
p_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL
57520-0210_8beba2b1-0e6f-47b4-aa69-1bdff7e5be07 57520-0210 HUMAN OTC DRUG
MBM 7 Lung Grief "Coccus cacti, Lung, Ignatia amara, Causticum, N
atrum muriaticum," LIQUID ORAL 20100426 UNAPPROVED HOMEO
PATHIC Apotheca Company CAUSTICUM; PROTORTONIA CACTI; SODIUM CHL
ORIDE; STRYCHNOS IGNATII SEED; SUS SCROFA LUNG 233; 3; 233; 89; 3 [hp_C]/m
L; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL
57520-0211_63aa6cef-c8ba-4dfb-a840-6c0f91b32b29 57520-0211 HUMAN OTC DRUG
MBM Small Intestine "Condurango, Intestine, Phytolacca decandra, Aco
nitum napellus, Aurum metallicum, Sulphur," LIQUID ORAL 20100503
UNAPPROVED HOMEOPATHIC Apotheca Company ACONITUM NAPELLUS; GOLD;
GOLDENSEAL; GRAPHITE; MARSDENIA CONDURANGO BARK; MERCURIUS SOLUBILIS; PHYTOLACC
A AMERICANA ROOT; PORK INTESTINE; PULSATILLA VULGARIS; SULFUR; SULFUR 55; 55;
89; 233; 3; 144; 3; 3; 233; 55; 89 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/
mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL
57520-0212_3e14e9d3-0c6a-422f-9784-5eac9220be8c 57520-0212 HUMAN OTC DRUG
MBM 9 Spleen Pancreas "Ceanothus americanus, Senna, Pancreas, Spleen,
Chioanthus virginica, Cinchona officinalis, Sepia," LIQUID ORAL 20100422
UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; CEANOT
HUS AMERICANUS LEAF; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; LYC
OPODIUM CLAVATUM SPORE; SENNA LEAF; SEPIA OFFICINALIS JUICE; SUS SCROFA PANCREAS
; SUS SCROFA SPLEEN 233; 3; 34; 144; 233; 3; 144; 5; 5 [hp_C]/mL; [hp_C
L
57520-0213_bbde3db1-f78b-43a8-ae99-25063219ce35 57520-0213 HUMAN OTC DRUG
MBM 10 Stomach "Condurango, Stomach, Nux vomica, Aurum metallicum, Anti
monium crudum, Hyoscyamus niger, Sulphur," LIQUID ORAL 20100422
UNAPPROVED HOMEOPATHIC Apotheca Company ANTIMONY TRISULFIDE; GOL
D; HYOSCYAMUS NIGER; MARSDENIA CONDURANGO BARK; STRYCHNOS NUX-VOMICA SEED; SULFU
R; SUS SCROFA STOMACH 233; 144; 233; 3; 89; 233; 5 [hp_C]/mL; [hp_C]/mL; [h
57520-0214_8d385528-9ae6-4742-a18e-8217d672ecbf 57520-0214 HUMAN OTC DRUG
MBM 11 Thyroid Adrenal "Iodium, Phytolacca decandra, Adrenalinum, Adren
ocorticotrophin, Thyroidinum, Belladonna, Phosphorus, Calcarea carbonica, Natrum
muriaticum, Nux moschata, Stramonium, Argentum nitricum," LIQUID ORAL
"ATROPA BELLADONNA; CORTICOTROPIN; DATURA STRAMONIUM; EPINEPHRINE; IODINE; NUTME
G; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT;
SILVER NITRATE; SODIUM CHLORIDE; THYROID" 34; 34; 89; 8; 3; 89; 89; 55; 3;
233; 89; 34 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL
; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL
57520-0215_6ff9a84c-90f1-4ad0-86c8-32a69067b95d 57520-0215 HUMAN OTC DRUG
MBM 12 Male Unresponsive "Chimaphila umbellata, Pituitarinum glan
d, Uva-ursi, Orchitinum, Prostate, Sarsaparilla," LIQUID ORAL 20100709
UNAPPROVED HOMEOPATHIC Apotheca Company "ARCTOSTAPHYLOS UVA-URSI
LEAF; CHIMAPHILA UMBELLATA; GELSEMIUM SEMPERVIRENS ROOT; PHOSPHORIC ACID; POTAS
SIUM PHOSPHATE, DIBASIC; SARSAPARILLA ROOT; SUS SCROFA PITUITARY GLAND; SUS SCRO
FA PROSTATE; SUS SCROFA TESTICLE; ZINC" 5; 3; 34; 233; 144; 55; 3; 8; 8; 55
[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp
_C]/mL; [hp_C]/mL; [hp_C]/mL
57520-0216_931cd89e-5ecf-4cee-adf5-f5c3d0931ab7 57520-0216 HUMAN OTC DRUG
MBM 13 Female "Phytolacca decandra, Pituitarinum gland, Scrophularia n
odosa, Hypothalamus gland, Calcarea carbonica, Cimicifuga racemosa," LIQUID
"BLACK COHOSH; CAUSTICUM; GRAPHITE; LILIUM TIGRINUM; OYSTER SHELL CALCIUM CARBON
ATE, CRUDE; PHYTOLACCA AMERICANA ROOT; POTASSIUM PHOSPHATE, DIBASIC; SCROPHULARI
A NODOSA; SULFUR; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PITUITARY GLAND" 89; 144;
144; 89; 89; 3; 233; 3; 89; 5; 3 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/
mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL
57520-0217_10514191-5382-4ba8-9694-40ccf8e16760 57520-0217 HUMAN OTC DRUG
Krebs Stimulator Plus "Tabebuia impetiginosa, Uncaria tomentosa, Hypot
halamus, Pituitary, Glandula suprarenalis, Nadidum, Lacticum acidum," LIQUID
"ADENOSINE TRIPHOSPHATE; BIS(CARBOXYETHYL)GERMANIUM SESQUIOXIDE; CAT'S CLAW; COE
NZYME A; LACTIC ACID, DL-; LACTIC ACID, L-; NADIDE; SUS SCROFA ADRENAL GLAND; SU
S SCROFA HYPOTHALAMUS; SUS SCROFA PITUITARY GLAND; TABEBUIA IMPETIGINOSA BARK; U
BIDECARENONE" 30; 8; 3; 30; 30; 30; 12; 60; 6; 200; 3; 200 [hp_X]/mL; [hp_X
L; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0218_60e44ce6-90ad-4c8e-ac13-de404a08cb08 57520-0218 HUMAN OTC DRUG
Allergy Composition "Chondrus crispus, Glycyrrhiza glabra, Zingiber
officinale, Amrposia artemisiaefolia," LIQUID ORAL 20100412
UNAPPROVED HOMEOPATHIC Apotheca Company AMBROSIA ARTEMISIIFOLIA;
CHONDRUS; GINGER; GLYCYRRHIZA GLABRA; HISTAMINE DIHYDROCHLORIDE; IODINE; LEVODO
PA; SCHOENOCAULON OFFICINALE SEED; SODIUM CARBONATE; TAURINE 6; 3; 3; 3; 4; 1
2; 6; 6; 12; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0219_29d1a0b3-4c84-41f3-b1a9-63d645481f2e 57520-0219 HUMAN OTC DRUG
Amoebasode "Triticum aestivum, Cajuputum, Baptisia tinctoria, Capsi
cum annuum, Columbo, Fragaria vesca, Quassia amara," LIQUID ORAL 20100412
UNAPPROVED HOMEOPATHIC Apotheca Company AMOEBA PROTEUS; BAPTISIA
TINCTORIA ROOT; BEEF LIVER; BOS TAURUS ADRENAL GLAND; CAJUPUT OIL; CAPSICUM; CI
NCHONA OFFICINALIS BARK; FRAGARIA VESCA FRUIT; GIARDIA LAMBLIA; JATEORHIZA CALUM
BA ROOT; LYCOPODIUM CLAVATUM SPORE; QUASSIA AMARA WOOD; SENNA LEAF; SUS SCROFA S
PLEEN; WHEAT; WORMWOOD 30; 3; 24; 30; 1; 3; 12; 3; 30; 3; 12; 3; 3; 24; 1; 6
[hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp
_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]
/mL; [hp_X]/mL
57520-0221_5027b20e-feb9-4c81-a791-ef42a3a52b2e 57520-0221 HUMAN OTC DRUG
Nephroplex "Berberis vulgaris, Hydrangea arborescens, Petroselinum
sativum, Solidago virguarea, Uva-ursi, Rubia tinctorum." LIQUID ORAL
ARCTOSTAPHYLOS UVA-URSI LEAF; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; EU
PATORIUM PURPUREUM ROOT; GLUTATHIONE; HYDRANGEA; MERCURIC CHLORIDE; PETROSELINUM
CRISPUM; PORK KIDNEY; RUBIA TINCTORUM ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP
mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0222_c249061a-1ec6-4329-b721-70d1af23c782 57520-0222 HUMAN OTC DRUG
OB Metab "Fucus vesiculosus, Capsicum annuum, Nicotinamidum, Spon
gia Tosta, Arginine, Croton oil, Ornithine Pituitary, Thyroidinum, Tyrosine, Cal
carea carbonica, Graphites, Kali carbonicum" LIQUID ORAL 20100330
UNAPPROVED HOMEOPATHIC Apotheca Company "ARGININE; CHILI PEPPER;
CROTON OIL; FUCUS VESICULOSUS; GRAPHITE; NIACINAMIDE; ORNITHINE; OYSTER SHELL C
ALCIUM CARBONATE, CRUDE; POTASSIUM CARBONATE; SPONGIA OFFICINALIS SKELETON, ROAS
TED; SUS SCROFA PITUITARY GLAND; THYROID; TYROSINE" 6; 3; 6; 2; 12; 5; 6; 12
X]/mL
57520-0223_b969e9ff-3c48-494d-bf28-021e36ffcf76 57520-0223 HUMAN OTC DRUG
Pure Oral hCG "hCG," LIQUID ORAL 20100810 UNAPPROV
ED HOMEOPATHIC Apotheca Company HUMAN CHORIONIC GONADOTROPIN
200 [hp_C]/mL
57520-0224_ceb09115-7968-4595-bc80-787707e656a2 57520-0224 HUMAN OTC DRUG
Melatonin Forte "Niacin, Melatonin, Nadidum, Pyridoxinum hydrochloricum,
Zincum sulphuricum, Hypothalamus, Lithium carbonicum, Magnesia carbonica, Pinea
l, Pituitary," SPRAY ORAL 20101007 20151108 UNAPPROVED HOMEO
PATHIC Apotheca Company LITHIUM CARBONATE; MAGNESIUM CARBONATE;
MELATONIN; NADIDE; NIACIN; PYRIDOXINE HYDROCHLORIDE; SUS SCROFA HYPOTHALAMUS; SU
S SCROFA PINEAL GLAND; SUS SCROFA PITUITARY GLAND; ZINC SULFATE HEPTAHYDRATE
8; 8; 6; 6; 3; 6; 8; 8; 8; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_
57520-0226_3a7c31f1-3553-4b1d-88fd-3afc53468ef0 57520-0226 HUMAN OTC DRUG
Serotonin Serotonin LIQUID ORAL 20100721
UNAPPROVED HOMEOPATHIC Apotheca Company SEROTONIN 30
[hp_C]/mL
57520-0227_41ba4bee-2d70-41e1-936d-fa968335fe99 57520-0227 HUMAN OTC DRUG
Systemic Detox "Berberis vulgaris, Boldo, Chelidonium majus, Hydrastis
canadensis, Lappa major, Taraxacum officinale, Trifolium pratense," LIQUID
ALOE; ARCTIUM LAPPA ROOT; BERBERIS VULGARIS ROOT BARK; CALCIUM SULFIDE; CHELIDON
IUM MAJUS; CONIUM MACULATUM FLOWERING TOP; ECHINACEA; GINKGO; GOLDENSEAL; LYCOPO
DIUM CLAVATUM SPORE; MARSDENIA CONDURANGO BARK; PEUMUS BOLDUS LEAF; SARSAPARILLA
ROOT; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; TABEBUIA IMPETIGINOSA BARK; TA
RAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG; TRIFOLIUM PRATENSE POLLEN
30; 3; 3; 12; 3; 12; 30; 6; 3; 12; 6; 3; 12; 30; 30; 6; 3; 30; 3 [hp_X]/m
_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0228_5ec5cdae-59cf-4784-98d8-af0bd086d05f 57520-0228 HUMAN OTC DRUG
Slim "Lycopodium clavatum, Phytolacca decandra, Abies canadensis, Amm
onium bromatum, Ammonium muriaticum, Pulsatilla, Kali bichromicum, Ammonium carb
onicum, Fucus vesiculosus," LIQUID ORAL 20101001 UNAPPROV
ED HOMEOPATHIC Apotheca Company "AMMONIUM BROMIDE; AMMONIUM CARB
ONATE; AMMONIUM CHLORIDE; ANTIMONY TRISULFIDE; BOS TAURUS ADRENAL GLAND; CALCIUM
ARSENATE; CAPSICUM; FUCUS VESICULOSUS; GRAPHITE; IODINE; IRON; LYCOPODIUM CLAVA
TUM SPORE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYTOLACCA AMERICANA ROOT; POT
ASSIUM CARBONATE; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SEMECARPUS ANACARDI
UM JUICE; SILICON DIOXIDE; SILVER NITRATE; SUS SCROFA THYROID; TSUGA CANADENSIS
BARK" 6; 6; 200; 4; 200; 200; 200; 200; 1; 4; 200; 3; 1; 3; 200; 200; 30; 4; 8
; 30; 5; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL
; [hp_X]/mL; [hp_X]/mL; [hp_Q]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_Q]/mL; [
hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_
C]/mL; [hp_X]/mL
57520-0229_83d577ff-9b8d-4825-acd6-47158294b2f8 57520-0229 HUMAN OTC DRUG
Pericardium Triple Warmer Meridian Opener Pericardium Triple Warme
r Meridian Opener LIQUID ORAL 20100330 UNAPPROVED HOMEO
PATHIC Apotheca Company "ARSENIC TRIOXIDE; BARIUM CARBONATE; GOL
D; IODINE; LACHESIS MUTA VENOM; LITHIUM CARBONATE; LOBELIA INFLATA; MERCURIUS SO
LUBILIS; NAJA NAJA VENOM; NITROGLYCERIN; OYSTER SHELL CALCIUM CARBONATE, CRUDE;
PHOSPHORIC ACID; PHOSPHORUS; POTASSIUM IODIDE; SEPIA OFFICINALIS JUICE; SPONGIA
OFFICINALIS SKELETON, ROASTED; THYROID" 30; 30; 30; 30; 30; 30; 30; 30; 30; 30;
30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_
C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/
mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL
57520-0231_3cb7a1c4-a44e-4f06-b80c-20e2632da6df 57520-0231 HUMAN OTC DRUG
Headache "Belladonna, Cimicifuga racemosa, Glonoinum, Lachesis mu
tus, Zingiber officinale," LIQUID ORAL 20100803 UNAPPROV
ED HOMEOPATHIC Apotheca Company ATROPA BELLADONNA; BLACK COHOSH;
GINGER; LACHESIS MUTA VENOM; NITROGLYCERIN 10; 10; 10; 10; 10 [hp_X]/m
57520-0232_d9a330cb-78c2-4b5b-bcea-08a14753713d 57520-0232 HUMAN OTC DRUG
Cardioforce I "Arnica montana, Cactus grandiflorus, Capsicum annuum, S
pigelia anthelmia, Digitalis purpurea, Kali phosphoricum, Laurocerasus, Tabacum,
" LIQUID ORAL 20100402 UNAPPROVED HOMEOPATHIC
Apotheca Company "ACONITUM NAPELLUS; AMANITA MUSCARIA VAR. MUSCARIA; ARNI
CA MONTANA; CHILI PEPPER; DIGITALIS; GOLD TRICHLORIDE; KALMIA LATIFOLIA LEAF; LA
TRODECTUS MACTANS VENOM; NITROGLYCERIN; POTASSIUM PHOSPHATE, DIBASIC; PRUNUS LAU
ROCERASUS LEAF; SELENICEREUS GRANDIFLORUS STEM; SPIGELIA; STRYCHNOS IGNATII SEED
; TOBACCO LEAF; VALERIAN" 12; 12; 3; 3; 6; 12; 12; 12; 12; 6; 6; 3; 3; 12;
57520-0233_7c6284ad-4bc0-4612-ae4b-33fdbc704437 57520-0233 HUMAN OTC DRUG
Mammaryplex "Echinacea angustifolia, Hydrastis canadensis, Myrrha, P
hytolacca decandra, Trigonella foenum-graecum, Lymph, Spleen, Bryonia alba, Bufo
rana, Conium maculatum," LIQUID ORAL 20101007 UNAPPROV
ED HOMEOPATHIC Apotheca Company BRYONIA ALBA ROOT; BUFO BUFO CUT
ANEOUS GLAND; CANIS LUPUS FAMILIARIS MILK; CONIUM MACULATUM FLOWERING TOP; ECHIN
ACEA ANGUSTIFOLIA; FENUGREEK SEED; GOLDENSEAL; LACHESIS MUTA VENOM; MYRRH; PHYTO
LACCA AMERICANA ROOT; SILICON DIOXIDE; SUS SCROFA LYMPH; SUS SCROFA MAMMA; SUS S
CROFA SPLEEN 12; 12; 12; 12; 3; 3; 3; 12; 3; 3; 12; 8; 8; 8 [hp_X]/mL; [hp_X
L; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL
57520-0234_25623427-1abb-437c-a673-bd9b2b7cd5f2 57520-0234 HUMAN OTC DRUG
Thyrotox "Chondrus crispus, Fucus vesiculosus, Thyroidinum, Bella
donna, Calcarea carbonica, Conium maculatum, Iodium, Kali carbonicum. Phosphorus
, Pulsatilla, Silicea," LIQUID ORAL 20101008 UNAPPROVED HOMEO
PATHIC Apotheca Company "ATROPA BELLADONNA; CHONDRUS CRISPUS; CO
NIUM MACULATUM FLOWERING TOP; FUCUS VESICULOSUS; IODINE; OYSTER SHELL CALCIUM CA
RBONATE, CRUDE; PHOSPHORUS; POTASSIUM CARBONATE; PULSATILLA VULGARIS; SILICON DI
OXIDE; SUS SCROFA THYROID" 12; 3; 12; 3; 12; 12; 12; 12; 12; 12; 8 [hp_X]/m
[hp_X]/mL; [hp_X]/mL; [hp_Q]/mL
57520-0235_78099676-cf2f-45e5-8f9e-17627dc75978 57520-0235 HUMAN OTC DRUG
30 [hp_X]/mL
57520-0236_bb18d011-7b72-4cc7-96e2-93d7c2e59630 57520-0236 HUMAN OTC DRUG
100 [hp_X]/mL
57520-0237_4d2ad7c9-e83a-4c2c-8f38-cb039a169a24 57520-0237 HUMAN OTC DRUG
Bio Vervain "Vervain," LIQUID ORAL 20100402
UNAPPROVED HOMEOPATHIC Apotheca Company VERBENA 200 [hp_C]/m
L
57520-0238_1ac987bd-7148-4f10-9dcf-ba8704a98fa7 57520-0238 HUMAN OTC DRUG
Res Balancer "Spleen, Thymus" SPRAY ORAL 20100405
UNAPPROVED HOMEOPATHIC Apotheca Company SUS SCROFA SPLEEN; THYMU
S 8; 8 [hp_X]/mL; [hp_X]/mL
57520-0239_ded4c506-15fe-4999-bc66-767b269e2c0a 57520-0239 HUMAN OTC DRUG
2 Gallbladder "Fel tauri, Chionanthus virginica, Arsenicum album, Nux
vomica, Platinum metallicum," LIQUID ORAL 20100802 UNAPPROV
ED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; BOS TAURUS BIL
E; CHIONANTHUS VIRGINICUS BARK; PLATINUM; STRYCHNOS NUX-VOMICA SEED 1; 3; 30
; 1; 1 [hp_M]/mL; [hp_X]/mL; [hp_C]/mL; [hp_M]/mL; [hp_M]/mL
57520-0241_88a97dee-8ca0-45d6-87a5-ee7165e29104 57520-0241 HUMAN OTC DRUG
Dr L Advanced HCG Formula "Chromium GTF, Hypothalamus, HCG, Garcin
ia cambogia," LIQUID ORAL 20101028 UNAPPROVED HOMEOPATHIC
Apotheca Company CHROMIUM PICOLINATE; HUMAN CHORIONIC GONADOTROPIN; HYDRO
XYCITRIC ACID; SUS SCROFA HYPOTHALAMUS 13; 34; 34; 13 [hp_C]/mL; [hp_C]/mL; [h
p_C]/mL; [hp_C]/mL
57520-0242_232e7157-bf42-4334-a548-4f7a3ea95426 57520-0242 HUMAN OTC DRUG
4 Kidney "Argentum nitricum, Arnica montana, Aconitum napellus, N
itricum acidum, Berberis vulgaris, Solidago virgaurea," LIQUID ORAL 20100820
UNAPPROVED HOMEOPATHIC Apotheca Company ACONITUM NAPELLUS; ARNIC
A MONTANA; BERBERIS VULGARIS ROOT BARK; NITRIC ACID; SILVER NITRATE; SOLIDAGO VI
RGAUREA FLOWERING TOP 1; 1; 30; 1; 1; 30 [hp_M]/mL; [hp_M]/mL; [hp_C]/mL;
[hp_M]/mL; [hp_M]/mL; [hp_C]/mL
57520-0243_5029a4cb-4017-47e6-af6e-e2d469e1fe72 57520-0243 HUMAN OTC DRUG
5 Large Intestine "Hyddrastis canadensis, Senna, Agaricus muscariu
s, Arnica montana, Baptisia tinctoria, Cuprum metallicum, Nitricum acidum,"
Company AMANITA MUSCARIA VAR. MUSCARIA; ARNICA MONTANA; BAPTISIA TINCTOR
IA ROOT; COPPER; GOLDENSEAL; NITRIC ACID; SENNA LEAF 1; 1; 1; 1; 3; 1; 3
[hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_X]/mL; [hp_M]/mL; [hp_X]/mL
57520-0244_b9f12fe9-e976-4335-b23d-9dc5aacc5c15 57520-0244 HUMAN OTC DRUG
6 Liver "Chelidonium majus, Cholesterinum, Arsenicum album, Belladonna,
Lycopodium clavatum, Tarentula hispana," LIQUID ORAL 20100921
BELLADONNA; CHELIDONIUM MAJUS; CHOLESTEROL; LYCOPODIUM CLAVATUM SPORE; LYCOSA T
ARANTULA 1; 1; 3; 30; 1; 10 [hp_M]/mL; [hp_M]/mL; [hp_X]/mL; [hp_C]/
mL; [hp_M]/mL; [hp_M]/mL
57520-0245_9a12fa87-6629-4079-8ffb-13799046eb0e 57520-0245 HUMAN OTC DRUG
7 Lung "Causticum, Natrum muriaticum, Ignatia amara, Coccus cacti,"
Company CAUSTICUM; PROTORTONIA CACTI; SODIUM CHLORIDE; STRYCHNOS IGNATII
SEED 1; 3; 5; 600 [hp_M]/mL; [hp_X]/mL; [hp_M]/mL; [hp_X]/mL
57520-0246_5f8456fe-9207-4409-ba09-fb1384b57a17 57520-0246 HUMAN OTC DRUG
8 Small Intestine "Condurango, Phytolacca decandra, Aconitum napel
lus, Aurum metallicum, Graphites, Hydrastis canadensis, Mercurius vivus, Sulphur
, Pulsatilla," LIQUID ORAL 20100802 UNAPPROVED HOMEOPATHIC
Apotheca Company ACONITUM NAPELLUS; GOLD; GOLDENSEAL; GRAPHITE; MARSDENIA
CONDURANGO BARK; MERCURY; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; SULFU
R 1; 1; 1; 1; 3; 1; 3; 10; 5 [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/
mL; [hp_X]/mL; [hp_M]/mL; [hp_X]/mL; [hp_M]/mL; [hp_M]/mL
57520-0248_546e2f66-74c5-4808-86c7-0b4adff97d22 57520-0248 HUMAN OTC DRUG
9 Spleen Pancreas "Ceanothus americanus, Senna, Chionanthus virgin
ica, Arsenicum album, Lycopodium clavatum, Sepia," LIQUID ORAL 20100802
UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; CEANOT
HUS AMERICANUS LEAF; CHIONANTHUS VIRGINICUS BARK; LYCOPODIUM CLAVATUM SPORE; SEN
NA LEAF; SEPIA OFFICINALIS JUICE 1; 3; 30; 1; 3; 1 [hp_M]/mL; [hp_X
]/mL; [hp_C]/mL; [hp_M]/mL; [hp_X]/mL; [hp_M]/mL
57520-0249_9805cbbb-63d8-475c-846b-0b59f9db0e84 57520-0249 HUMAN OTC DRUG
10 Stomach "Condurango, Antimonium crudum, Aurum metallicum, Hyoscy
amus niger, Nux vomica, Sulphur," LIQUID ORAL 20100803
UNAPPROVED HOMEOPATHIC Apotheca Company ANTIMONY TRISULFIDE; GOL
D; HYOSCYAMUS NIGER; MARSDENIA CONDURANGO BARK; STRYCHNOS NUX-VOMICA SEED; SULFU
R 1; 1; 1; 3; 1; 1 [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_X]/mL; [hp_
M]/mL; [hp_M]/mL
57520-0250_e95de5c6-2642-4a08-9208-aae58e3801f2 57520-0250 HUMAN OTC DRUG
Inflammation II "Asafoetida, Kalmia latifolia, Causticum, Coldhicum autu
mnale, Ferrum metallicum, Gnaphalium polycephalum, Lithium benzoicum" LIQUID
"ASAFETIDA; CAUSTICUM; COLCHICUM AUTUMNALE BULB; FILIPENDULA ULMARIA ROOT; IRON;
KALMIA LATIFOLIA LEAF; LITHIUM BENZOATE; MERCURIC OXIDE, YELLOW; PSEUDOGNAPHALI
UM OBTUSIFOLIUM; TOXICODENDRON PUBESCENS LEAF" 8; 10; 10; 10; 10; 8; 10; 10; 10
; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]
57520-0251_aa37ab13-8a75-4e6f-90bc-2a84a83901c4 57520-0251 HUMAN OTC DRUG
11 Thyroid Adrenal "Iodium, Phytolacca decandra, Adrenalinum, Adren
ocorticotrophin, Belladonna, Thyroidinum, Natrum muriaticum," LIPSTICK
"ATROPA BELLADONNA; CORTICOTROPIN; EPINEPHRINE; IODINE; NUTMEG; OYSTER SHELL CAL
CIUM CARBONATE, CRUDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; SILVER NITRATE; SO
DIUM CHLORIDE; THYROID" 30; 6; 6; 3; 1; 1; 1; 3; 1; 200; 30 [hp_C]/mL; [hp_X
]/mL; [hp_X]/mL; [hp_X]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_X]/mL; [hp_M]/m
L; [hp_C]/mL; [hp_C]/mL
57520-0252_9519d3f4-4833-4aa2-b320-959e826ab3b9 57520-0252 HUMAN OTC DRUG
13 Female "Phytolacca decandra, Scrophularia nodosa, Cimicifuga ra
cemosa, Lilium tigrinum, Sulphur, Graphites," LIQUID ORAL 20100804
UNAPPROVED HOMEOPATHIC Apotheca Company "BLACK COHOSH; CAUSTICUM
; GRAPHITE; LILIUM TIGRINUM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYTOLACCA A
MERICANA ROOT; POTASSIUM PHOSPHATE, DIBASIC; SCROPHULARIA NODOSA; SULFUR"
200; 1; 1; 1; 1; 3; 1; 3; 1 [hp_C]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_
M]/mL; [hp_X]/mL; [hp_M]/mL; [hp_X]/mL; [hp_M]/mL
57520-0254_c6e691fc-5ee3-483c-866d-dbe6af1bd2cd 57520-0254 HUMAN OTC DRUG
Adrenapar "Aralia quinquefolia, Avena sativa Glandula suprarenalis
, Arsenicum iodatum, Ignatia amara, Lycopodium clavatum, Nux vomica," LIQUID
AMERICAN GINSENG; ARSENIC TRIIODIDE; AVENA SATIVA FLOWERING TOP; LYCOPODIUM CLAV
ATUM SPORE; PHOSPHORIC ACID; PHOSPHORUS; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-V
OMICA SEED; SUS SCROFA ADRENAL GLAND; ZINC 3; 12; 3; 12; 12; 12; 12; 12; 6;
57520-0256_e67d500d-50aa-4be7-995d-7ae6def04a65 57520-0256 HUMAN OTC DRUG
Phytolacca Phytolacca decandra LIQUID ORAL 20100504
20150520 UNAPPROVED HOMEOPATHIC Apotheca Company PHYTOLAC
CA AMERICANA ROOT 200 [hp_C]/mL
57520-0259_b4617c9e-15dd-4426-a993-de401d1626c5 57520-0259 HUMAN OTC DRUG
Stress Mints "Avena sativa, Agrimonia eupatoria, Aconitum napellus, A
rnica montana, Ignatia amara, Chamomilla, Nux vomica, Pulsatilla," LOZENGE
ACONITUM NAPELLUS; AGRIMONIA EUPATORIA; ARNICA MONTANA; AVENA SATIVA FLOWERING T
OP; CHAMOMILE; PULSATILLA VULGARIS; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA
SEED 12; 3; 12; 1; 30; 30; 12; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1;
[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
57520-0260_af163716-c8be-47b1-8c8e-e30df1b5b55f 57520-0260 HUMAN OTC DRUG
Calm Drops "Aconitum napellus, Arsenicum album, Calcarea carbonica,
Chamomilla, Ignatia amara, Kali carbonicum, Lachesis mutus, Natrum muriaticum,
Nux vomica, Phosphoricum acidum, Pulsatilla, Sepia," LOZENGE ORAL 20110415
UNAPPROVED HOMEOPATHIC Apotheca Company "ACONITUM NAPELLUS; ARSE
NIC TRIOXIDE; CHAMOMILE; LACHESIS MUTA VENOM; OYSTER SHELL CALCIUM CARBONATE, CR
UDE; PHOSPHORIC ACID; POTASSIUM CARBONATE; PULSATILLA VULGARIS; SEPIA OFFICINALI
S JUICE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED"
6; 30; 12; 12; 30; 3; 30; 12; 30; 12; 30; 30 [hp_X]/1; [hp_C]/1; [hp_X]/1; [h
p_X]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_X]/1; [hp_X]/1; [h
p_C]/1
57520-0261_145cfaa9-048f-4d51-8409-9700552ab4a2 57520-0261 HUMAN OTC DRUG
Moon Drops "Chamomilla, Coffea cruda, Arsenicum album, Ignatia amar
a, Lycopodium clavatum, Natrum muriaticum, Nux vomica, Gelsemium sempervirens, V
aleriana officinalis," LOZENGE ORAL 20101012 UNAPPROVED HOMEO
PATHIC Apotheca Company ARABICA COFFEE BEAN; ARSENIC TRIOXIDE; C
HAMOMILE; GELSEMIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORID
E; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; VALERIAN 12; 30; 6; 12; 3
0; 30; 30; 30; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1; [hp_X]/1; [hp_X]
/1; [hp_X]/1; [hp_X]/1; [hp_C]/1
57520-0262_5e7fe540-da3b-4422-b888-e30f4d42a8ba 57520-0262 HUMAN OTC DRUG
Dentaforce "Antimonium crudum, Belladonna, Calcarea carbonica,"
Company "ANTIMONY TRISULFIDE; ATROPA BELLADONNA; CALCIUM FLUORIDE; HEKLA
LAVA; HYDROFLUORIC ACID; LEAD; MERCURIUS SOLUBILIS; OYSTER SHELL CALCIUM CARBON
ATE, CRUDE; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; TRIBASIC CALCIUM PHOSPHATE
" 12; 12; 12; 12; 30; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [h
]/mL; [hp_X]/mL
57520-0263_13e17f95-8a0c-47be-952a-fbadeba088d4 57520-0263 HUMAN OTC DRUG
Rhustoxoforce "Apis mellifica, Cantharis, Graphites, Natrun muriaticum
, Rhus glabra, Rhus toxicodendron, Thus venenata, Urtica dioica," LIQUID
APIS MELLIFERA; GRAPHITE; LYTTA VESICATORIA; RHUS GLABRA TOP; SODIUM CHLORIDE; T
OXICODENDRON PUBESCENS LEAF; TOXICODENDRON VERNIX LEAFY TWIG; URTICA DIOICA
57520-0264_3d25ae5c-7c89-4687-9d18-7fb3ff59f32d 57520-0264 HUMAN OTC DRUG
Taurine "Taurine," LIQUID ORAL 20101025 UNAPPROV
ED HOMEOPATHIC Apotheca Company TAURINE 30 [hp_C]/mL
57520-0265_d03e1bc2-1ddf-46b1-a40e-7eb19e1440fb 57520-0265 HUMAN OTC DRUG
Trauma Free "Symphytum officinale, Bellis perennis, Hypericum perfor
atum,, Magnesia phosphorica, Ruta graveolens, Arnica montana," LIQUID ORAL
"ARNICA MONTANA; BELLIS PERENNIS; COMFREY ROOT; HYPERICUM PERFORATUM; MAGNESIUM
PHOSPHATE, DIBASIC TRIHYDRATE; RUTA GRAVEOLENS FLOWERING TOP" 200; 12; 3; 12;
30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0266_b5925bc7-0841-4d6b-8a0b-738a08f3e04a 57520-0266 HUMAN OTC DRUG
V HP "Arsenicum album, Belladonna, Echinacea angustifolia, Eupatorium
perfoliatum, Gelsemium sempervirens, Lycopodium clavatum, Phosphoricum acidum,
Phosphorus, Pyrogenium, Rhus toxicodendron," LIQUID ORAL 20101026
BELLADONNA; ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSE
MIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PHOSPHORUS;
RANCID BEEF; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30;
57520-0268_de2c1c2f-6621-4027-97bd-f5ad10374f85 57520-0268 HUMAN OTC DRUG
Injury "Arnica montana, Calendula officinalis, Symphytum officinale, Hy
pericum perforatum, Belladonna, Bellis perennis, Carbo vegetabilis," LIQUID
ACHILLEA MILLEFOLIUM; ACTIVATED CHARCOAL; ARNICA MONTANA; ATROPA BELLADONNA; BEL
LIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; HAMAMELIS VIRGI
NIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; RUTA GRAVEOLENS FLOWERING TOP;
TOXICODENDRON PUBESCENS LEAF; VERATRUM ALBUM ROOT 12; 12; 3; 12; 12; 3; 3;
hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0271_96883a55-8231-4331-8a76-b92e824fef6e 57520-0271 HUMAN OTC DRUG
Glutathione "Glutathione," LIQUID ORAL 20100729
UNAPPROVED HOMEOPATHIC Apotheca Company GLUTATHIONE 6
[hp_X]/mL
57520-0272_e1b840f7-a357-448e-bef7-d4ed2b3a43c4 57520-0272 HUMAN OTC DRUG
Fibro Relief "Ferrum metallicum, Guaiacum, Lithium carbonicum, Lycope
rsicum esculentum, Magnesia phosphorica" CAPSULE ORAL 20101217
UNAPPROVED HOMEOPATHIC Apotheca Company "GUAIACUM OFFICINALE RES
IN; IRON; LITHIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOMATO"
30; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1
57520-0273_76938ffd-dcec-4986-933d-680abeeecfcc 57520-0273 HUMAN OTC DRUG
UR-IN-Control "Belladonna, Apis mellifica, Argetnum nitricum, Canthari
s, Equisetum arvense, Pulsatilla, Sarsaparilla, Terebinthina, Causticum, Petrose
linum sativum," LIQUID ORAL 20101026 UNAPPROVED HOMEOPATHIC
Apotheca Company APIS MELLIFERA; ATROPA BELLADONNA; CAUSTICUM; EQUISETUM
ARVENSE TOP; LYTTA VESICATORIA; PETROSELINUM CRISPUM; PULSATILLA VULGARIS; SARSA
PARILLA ROOT; SILVER NITRATE; TURPENTINE 6; 4; 8; 6; 6; 8; 6; 6; 6; 6
_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0283_d4c9f68b-0683-4de3-9507-bfb223d441b5 57520-0283 HUMAN OTC DRUG
Candida Candida albicans LIQUID ORAL 20100408
200 [hp_C]/mL
57520-0284_63b42a73-6f1e-4dc2-ba8f-4b6167fa6d15 57520-0284 HUMAN OTC DRUG
Candida-Ease "Borax, Arsenicum album, Conium maculatum, Kreosotum, Ly
copodium clavatum, Phosphorus, Pulsatilla, Sepia, Sulphur," LIQUID ORAL
"ARSENIC TRIOXIDE; ASPERGILLUS NIGER VAR. NIGER; CANDIDA ALBICANS; CANDIDA PARAP
SILOSIS; CANDIDA TORRESII; CANDIDA TROPICALIS; CONIUM MACULATUM FLOWERING TOP; L
YCOPODIUM CLAVATUM SPORE; MUCOR RACEMOSUS; OYSTER SHELL CALCIUM CARBONATE, CRUDE
; PHOSPHORUS; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SODIUM BORATE; SULFU
R; WOOD CREOSOTE" 200; 200; 6; 6; 200; 200; 200; 200; 200; 200; 200; 200;
200; 3; 200; 200 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [
hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_
57520-0285_e428ae4c-48c3-4058-b8f3-21b2756cb70f 57520-0285 HUMAN OTC DRUG
Gallbladder Liver MO "Arsenicum album, Berberis vulgaris, Bryonia alb
a, Calcarea carbonica, Carduus marianus, Cinchona officinalis, Kali Carbonicum,
Lycopodium clavatum, Natrum sulphuricum, Nux vomica, Phosphorus," LIQUID
ORAL 20100408 20150922 UNAPPROVED HOMEOPATHIC Apotheca
Company "ARSENIC TRIOXIDE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROO
T; CINCHONA OFFICINALIS BARK; LYCOPODIUM CLAVATUM SPORE; OYSTER SHELL CALCIUM CA
RBONATE, CRUDE; PHOSPHORUS; POTASSIUM CARBONATE; SILYBUM MARIANUM SEED; SODIUM S
ULFATE; STRYCHNOS NUX-VOMICA SEED" 30; 30; 30; 30; 30; 30; 30; 30; 30; 30;
30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]
/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL
57520-0287_bd147e42-5527-41c3-b753-daa20755ebcd 57520-0287 HUMAN OTC DRUG
Muscle Cramp and Spasm Relief "Causticum, Colocynthis, Cuprum metallic
um, Magnesia phosphorica, Phytolacca decandra, Rhus toxicodendron, Stannum metal
licum, Veratrum album," TABLET ORAL 20101027 20151230 UNAPPROV
ED HOMEOPATHIC Apotheca Company "CAUSTICUM; CITRULLUS COLOCYNTHI
S FRUIT PULP; COPPER; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PHYTOLACCA AMERIC
ANA ROOT; TIN; TOXICODENDRON PUBESCENS LEAF; VERATRUM ALBUM ROOT" 30; 30;
30; 30; 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]
/1; [hp_X]/1; [hp_X]/1
57520-0288_16629aa4-0a24-4733-a6a5-fb88ed6aa918 57520-0288 HUMAN OTC DRUG
Hypothalmus Tincture "Aralia quinquefolia, Hydrocotyle asiatica, Poly
gonum multiflorum, Hypothalamus, Pituitarum posterium, Germanium sesquioxide, Pi
neal," LIQUID ORAL 20101028 UNAPPROVED HOMEOPATHIC
Apotheca Company AMERICAN GINSENG; CENTELLA ASIATICA; FALLOPIA MULTIFLORA
ROOT; GERMANIUM SESQUIOXIDE; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PINEAL GLAND;
SUS SCROFA PITUITARY GLAND 3; 3; 3; 12; 8; 14; 8 [hp_X]/mL; [hp_X]/mL; [h
57520-0289_15ffd03f-6140-4dfe-8db3-3202e0d539fe 57520-0289 HUMAN OTC DRUG
Happy Happy "Aurum metallicum, Lithium carbonicum, Serotonin,"
Company GOLD; LITHIUM CARBONATE; SEROTONIN 30; 6; 30 [hp_X]/m
L; [hp_X]/mL; [hp_C]/mL
57520-0290_766836d8-d3c3-405a-9070-85cfe95c204c 57520-0290 HUMAN OTC DRUG
Viral Plus "Arsenicum album, Belladonna, Echinacea, Eupatorium perf
oliatum, Gelsemium sempervirens, Lycopodium clavatum, Phosphoricum acidum, Phosp
horus, Pyrogenium, Rhus Toxicodendron," LIQUID ORAL 20101028
BELLADONNA; ECHINACEA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVI
RENS ROOT; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PHOSPHORUS; RANCID BEEF;
TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/m
57520-0292_de56ee5e-a350-49b3-85ad-021b5fd4dc44 57520-0292 HUMAN OTC DRUG
Sinusitis Sinusitis LIQUID ORAL 20100414
UNAPPROVED HOMEOPATHIC Apotheca Company "CALCIUM SULFIDE; EUPHOR
BIA RESINIFERA RESIN; LUFFA OPERCULATA FRUIT; MERCURIC IODIDE; OYSTER SHELL CALC
IUM CARBONATE, CRUDE; PLANTAGO MAJOR; PULSATILLA VULGARIS; SILVER NITRATE; SINUS
ITISINUM; SODIUM CHLORIDE; SUS SCROFA NASAL MUCOSA" 10; 4; 6; 8; 12; 3; 2; 1
57520-0293_73330513-c9ec-4f60-a575-80f0cc5504af 57520-0293 HUMAN OTC DRUG
Spleen "Spleen," SPRAY ORAL 20101028 UNAPPROV
ED HOMEOPATHIC Apotheca Company SUS SCROFA SPLEEN 6
[hp_X]/mL
57520-0294_6a3f6293-ea49-4eac-b9e8-03497b5e5cf1 57520-0294 HUMAN OTC DRUG
Throat Formula "Baptisia Tinctoria, Phytolacca decandra, Apis mellifica
, Belladonna, Lachesis mutus, Mercurius solubilis, Hepar sulphuris calcareum,"
Company APIS MELLIFERA; ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; CALC
IUM SULFIDE; LACHESIS MUTA VENOM; MERCURIUS SOLUBILIS; PHYTOLACCA AMERICANA ROOT
57520-0295_0a66ee3e-50b1-4069-bc31-3132b93669c8 57520-0295 HUMAN OTC DRUG
Sinutone "Echinacea, Hydrastis canadensis, Allium cepa, Ambrosia
artemesiaefolia, Arsenicum album, Kali bichromicum, Nux moschata, Pulsatilla, Se
pia, Solidago virgaurea," LIQUID ORAL 20101110 UNAPPROV
ED HOMEOPATHIC Apotheca Company AMBROSIA ARTEMISIIFOLIA; ARSENIC
TRIOXIDE; ECHINACEA; GOLDENSEAL; NUTMEG; ONION; POTASSIUM DICHROMATE; PULSATILL
A VULGARIS; SEPIA OFFICINALIS JUICE; SOLIDAGO VIRGAUREA FLOWERING TOP 12; 12;
57520-0297_dbd01e76-e98b-4814-9510-8113721d7434 57520-0297 HUMAN OTC DRUG
Allerstat II "Baptisia tinctoria, Echinacea, Allium cepa, Ambrosia ar
temisiaefolia, Arsenicum album," LIQUID ORAL 20100412
ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; ECHINACEA; EUPHRASIA STRICTA; ONION;
PHOSPHORUS; PULSATILLA VULGARIS; SODIUM SULFATE; SOLIDAGO VIRGAUREA FLOWERING T
OP; STRYCHNOS NUX-VOMICA SEED; SULFUR 12; 12; 3; 3; 12; 12; 12; 12; 12; 12; 12
; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]
/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0298_576bf341-ffa7-43c7-9486-302d970bb92c 57520-0298 HUMAN OTC DRUG
Venoforce I "Aesculus hippocastanum, Collinsonia canadensis, Echinac
ea angustifolia, Hamamelis virginiana, Pulsatilla, Arnica montana, Carbo vegetab
ilis," LIQUID ORAL 20100715 UNAPPROVED HOMEOPATHIC
Apotheca Company ACTIVATED CHARCOAL; ARNICA MONTANA; COLLINSONIA CANADENS
IS ROOT; ECHINACEA ANGUSTIFOLIA; GRAPHITE; HAMAMELIS VIRGINIANA ROOT BARK/STEM B
ARK; HORSE CHESTNUT; HYDROFLUORIC ACID; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID;
PAEONIA OFFICINALIS ROOT; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; STRYCHNO
S NUX-VOMICA SEED 12; 12; 3; 3; 12; 3; 3; 12; 12; 12; 12; 3; 12; 12
_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0299_a4846c95-da72-406b-819f-165016a18ccb 57520-0299 HUMAN OTC DRUG
Relaxoforce "Humulus lupulus, Passiflora incarnata, Valeriana offici
nalis, Calcarea carbonica, Coffea tosta, Ignatia amara, Kali phosphoricum, Mosch
us, Nux vomica, Phosphorus, Pulsatilla," LIQUID ORAL 20100930
UNAPPROVED HOMEOPATHIC Apotheca Company "COFFEE BEAN; HOPS; MOSC
HUS MOSCHIFERUS MUSK SAC RESIN; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PASSIFLOR
A INCARNATA TOP; PHOSPHORUS; POTASSIUM PHOSPHATE, DIBASIC; PULSATILLA VULGARIS;
STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; VALERIAN" 12; 3; 12; 12; 3
; 12; 12; 12; 12; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [
57520-0300_39cf5c1f-e3b5-443a-a4c4-da068c1d9ae0 57520-0300 HUMAN OTC DRUG
Viscumforce "Passiflora incarnata, Valeriana officinalis, Aurum meta
llicum, Bartya carbonica, Glonoinum, Phosphorus, Plumbum metallicum, Viscum albu
m," LIQUID ORAL 20100929 UNAPPROVED HOMEOPATHIC
Apotheca Company BARIUM CARBONATE; GOLD; LEAD; NITROGLYCERIN; PASSIFLORA
INCARNATA TOP; PHOSPHORUS; VALERIAN; VISCUM ALBUM FRUITING TOP 12; 12; 12; 12;
57520-0301_d8728f43-6763-4920-a906-716b1d56622f 57520-0301 HUMAN OTC DRUG
Progesterone "Progesterone," LIQUID ORAL 20101008
UNAPPROVED HOMEOPATHIC Apotheca Company PROGESTERONE 30
[hp_C]/mL
57520-0302_e0cb67bb-dc44-4bb5-ad26-c1eec875ae1f 57520-0302 HUMAN OTC DRUG
[hp_C]/mL
57520-0303_c57ff82d-1dfd-454e-98fc-4f20fa4727e2 57520-0303 HUMAN OTC DRUG
Renaforce "Berberis vulgaris, Echinacea angustifolia, Coccus cacti
, Kali muriaticum, Lycopodium clavatum, Nitricum acidum," LIQUID ORAL
BERBERIS VULGARIS ROOT BARK; ECHINACEA ANGUSTIFOLIA; LYCOPODIUM CLAVATUM SPORE;
NITRIC ACID; POTASSIUM CHLORIDE; PROTORTONIA CACTI 3; 3; 12; 12; 12; 12
57520-0304_3a7e9963-24ca-4102-be56-4995c1167071 57520-0304 HUMAN OTC DRUG
Relaxatone "Passiflora incarnata, Scutellaria lateriflora, Valerian
a officinalis, Arsenicum album, Calcarea carbonica, Coffea cruda, Ignatia amara,
Kali phosphoricum Lycopus virginicus, Staphysagria" LIQUID ORAL 20101111
UNAPPROVED HOMEOPATHIC Apotheca Company "ARABICA COFFEE BEAN; AR
SENIC TRIOXIDE; DELPHINIUM STAPHISAGRIA SEED; LYCOPUS VIRGINICUS; OYSTER SHELL C
ALCIUM CARBONATE, CRUDE; PASSIFLORA INCARNATA TOP; POTASSIUM PHOSPHATE, DIBASIC;
SCUTELLARIA LATERIFLORA; STRYCHNOS IGNATII SEED; VALERIAN" 12; 12; 12; 12;
hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0305_d4903c91-e50f-493d-ad3f-0fd0cb4c2147 57520-0305 HUMAN OTC DRUG
Headache HP "Belladonna, Bryonia, Gelsemium sempervirens, Glonionum,
Melilotus officinalis, Natrum muriaticum, Nitricum acidum, Nux vomica, Silicea
Spigelia anthelmia" LIQUID ORAL 20100412 UNAPPROVED HOMEO
PATHIC Apotheca Company ATROPA BELLADONNA; BRYONIA ALBA ROOT; GE
LSEMIUM SEMPERVIRENS ROOT; MELILOTUS OFFICINALIS POLLEN; NITRIC ACID; NITROGLYCE
RIN; SILICON DIOXIDE; SODIUM CHLORIDE; SPIGELIA; STRYCHNOS NUX-VOMICA SEED
mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0306_30ec071d-41d5-47a5-bdd0-18c3b7ccc95d 57520-0306 HUMAN OTC DRUG
Tinnitus HP "Ginkgo biloba, Chininum sulphuricum, Cinchona officinal
is, Graphites, Natrum salicylicum, Plumbum metallicum," LIQUID ORAL 20100412
UNAPPROVED HOMEOPATHIC Apotheca Company ALLYLTHIOUREA; ASPIRIN;
CINCHONA OFFICINALIS BARK; GINKGO; GRAPHITE; LEAD; QUININE SULFATE; SODIUM SALIC
YLATE; SPIGELIA 30; 30; 30; 6; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [h
57520-0307_407629b0-4a19-4eba-b1f0-3efdbf6ded73 57520-0307 HUMAN OTC DRUG
Thyropar "Fucus vesiculosus, Spongia tosta, Glandula suprarenalis
Apotheca Company "BROMINE; FUCUS VESICULOSUS; IODINE; LACHESIS MUTA VENOM
; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PULSATILLA VULGARIS; SPONGIA OFFICINALI
S SKELETON, ROASTED; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; THYRO
ID" 12; 3; 12; 12; 12; 12; 3; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL;
57520-0308_aeda3c9c-17c8-43c0-a451-0d0c5bef4468 57520-0308 HUMAN OTC DRUG
Candida Alb "Candida albicans," LIQUID ORAL 20100716
12 [hp_X]/mL
57520-0309_1fb04c98-cf03-41e7-931a-885a2467fca3 57520-0309 HUMAN OTC DRUG
Arnica Plus "Arnica montana, Hamamelis virginiana, Rhus toxicodendro
n," GEL TOPICAL 20110315 UNAPPROVED HOMEOPATHIC
Apotheca Company ARNICA MONTANA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK
; TOXICODENDRON PUBESCENS LEAF 12; 12; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g
57520-0310_6a532fad-5d7a-4fb2-be8d-7073377c0544 57520-0310 HUMAN OTC DRUG
Recovatone "Glycyrrhiza glabra, Kali muriaticum Magnesia muriatica,
Tribulus terrestris, Zincum gluconicum, Kali phosphoricum, Natrum muriaticum, I
odium, Phosphorus, Adrenalinum, Adrenocorticotrophin, Ascorbicum" LIQUID
"ARGININE; ASCORBIC ACID; BORON; CALCIUM GLUCONATE; CHROMIUM; COBALTOUS GLUCONAT
E; COPPER GLUCONATE; CORTICOTROPIN; CREATINE; EPINEPHRINE; FERROUS GLUCONATE; GL
UTAMINE; GLYCYRRHIZA GLABRA; IODINE; LEUCINE; LEVOCARNITINE; MAGNESIUM CHLORIDE;
MAGNESIUM GLUCONATE; MANGANESE GLUCONATE; MOLYBDENUM; NICKEL; ORNITHINE; PHOSPH
ORUS; POTASSIUM CHLORIDE; POTASSIUM GLUCONATE; POTASSIUM PHOSPHATE, DIBASIC; SEL
ENIUM; SELENIUM DIOXIDE; SODIUM CHLORIDE; STRONTIUM CARBONATE; TRIBASIC CALCIUM
PHOSPHATE; TRIBULUS TERRESTRIS FRUIT; VALINE; VANADIUM; ZINC GLUCONATE" 6; 6; 12
; 6; 8; 6; 6; 6; 6; 6; 6; 6; 1; 4; 6; 6; 2; 6; 6; 8; 8; 6; 5; 2; 6; 3; 8; 8; 3;
p_X]/mL
57520-0311_89716561-04ff-46b6-abe2-af32767bd50e 57520-0311 HUMAN OTC DRUG
Joint Rescue "Symphytum officinale, Capsicum annuum, Ledum palustre,
Colchicum autumnale, Rhododendron chrysanthum, Ruta graveolens," GEL
TOPICAL 20110311 UNAPPROVED HOMEOPATHIC Apotheca Company
CAPSICUM; COLCHICUM AUTUMNALE BULB; COMFREY ROOT; LEDUM PALUSTRE TWIG; RHODODEND
RON AUREUM LEAF; RUTA GRAVEOLENS FLOWERING TOP 6; 12; 3; 6; 12; 12 [hp_X]/g
; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g
57520-0313_8ae865b6-392b-4dad-a2a6-dd5e4728a35a 57520-0313 HUMAN OTC DRUG
Tendon Rescue "Bryonia, Ruta graveolens, Bellis perennis, Argentum met
allicum," GEL TOPICAL 20110315 UNAPPROVED HOMEOPATHIC
Apotheca Company BELLIS PERENNIS; BRYONIA ALBA ROOT; RUTA GRAVEOLENS FLOW
ERING TOP; SILVER 6; 12; 12; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g
57520-0316_061c4e71-a247-4b61-81fa-44c63b60a338 57520-0316 HUMAN OTC DRUG
Muscle Rescue "Arnica montana, Rhus toxicodendron, Phytolacca decandra
, Pulsatilla, Ruta graveolens," GEL TOPICAL 20110316 UNAPPROV
ED HOMEOPATHIC Apotheca Company ARNICA MONTANA; PHYTOLACCA AMERI
CANA ROOT; PULSATILLA VULGARIS; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUB
ESCENS LEAF 3; 12; 12; 12; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g;
[hp_X]/g
57520-0318_6ff12212-9233-490c-b2d1-1eb843bc1b0c 57520-0318 HUMAN OTC DRUG
Natural Progesterone Natural Progesterone SPRAY ORAL 20100415
[hp_X]/mL
57520-0319_2a882aa6-7e4d-4b90-876c-1c0268fcc2f1 57520-0319 HUMAN OTC DRUG
Natural Testosterone "Avena sativa, Epimedium, Lycopodium clavatum, A
ndrostenedione, Damiana, Testosterone, Agnus castus," SPRAY ORAL 20100420
UNAPPROVED HOMEOPATHIC Apotheca Company ANDROSTENEDIONE; AVENA S
ATIVA FLOWERING TOP; CHASTE TREE; EPIMEDIUM GRANDIFLORUM FLOWERING TOP; LYCOPODI
UM CLAVATUM SPORE; TURNERA DIFFUSA LEAFY TWIG 6; 3; 12; 3; 3; 6 [hp_X]/m
L; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0320_dd0611da-b165-414e-bac5-e7a113e5f6bd 57520-0320 HUMAN OTC DRUG
Calcium Composition "Arnica montana, Echinacea, Boron Gluconate, Sym
phytum officinale, Hekla lava, Calcarea carbonica, Calcarea fluorica," LIQUID
"ARNICA MONTANA; BORON GLUCONATE; CALCIUM FLUORIDE; COMFREY ROOT; ECHINACEA; HEK
LA LAVA; LYCOPODIUM CLAVATUM SPORE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SILIC
ON DIOXIDE; TRIBASIC CALCIUM PHOSPHATE" 3; 12; 30; 30; 3; 30; 30; 30; 200; 30
57520-0321_7744e663-bb51-49d0-8a5c-f770729bf8cc 57520-0321 HUMAN OTC DRUG
Cerebral Composition "Cholinum. Capsicum annuum, Ginkgo biloba, Arnic
a montana, Gelsemium sempervirens, Kali Phosphoricum, Anacardium orientale, Bary
ta Carbonica, Phosphorus, Serotonin," LIQUID ORAL 20100426
UNAPPROVED HOMEOPATHIC Apotheca Company "ARNICA MONTANA; BARIUM
CARBONATE; CHILI PEPPER; CHOLINE HYDROXIDE; GELSEMIUM SEMPERVIRENS ROOT; GINKGO;
PHOSPHORUS; POTASSIUM PHOSPHATE, DIBASIC; SEMECARPUS ANACARDIUM JUICE; SEROTONI
N" 6; 12; 3; 3; 6; 3; 12; 6; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL;
57520-0322_4fed67f6-23fe-4bd9-8cba-e789a7a340c2 57520-0322 HUMAN OTC DRUG
Colloidal Silver "Colloidal silver," LIQUID ORAL 20100419
UNAPPROVED HOMEOPATHIC Apotheca Company SILVER 12 [hp_X]/m
L
57520-0323_d05ba894-7dbf-4d2d-b0d6-cf41f645c6aa 57520-0323 HUMAN OTC DRUG
Bowel Nosode B Faecalis Bowel Nosode B Faecalis LIQUID ORAL 20100512
UNAPPROVED HOMEOPATHIC Apotheca Company ALCALIGENES FAECALIS; SE
PIA OFFICINALIS JUICE 30; 3 [hp_C]/mL; [hp_X]/mL
57520-0324_ac21ada6-dce8-4f35-a1f2-8d263c26b599 57520-0324 HUMAN OTC DRUG
Lymph Detox Plus "Apis mellifica, Arnica montana, Berberis vulgar
is, Gelsemium sempervirens, Hydrastis canadensis, Phytolacca decandra," LIQUID
APIS MELLIFERA; ARNICA MONTANA; BERBERIS VULGARIS ROOT BARK; CHELIDONIUM MAJUS;
GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; LACHESIS MUTA VENOM; PHYTOLACCA AMERICA
NA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF 3; 3; 3;
57520-0326_dff7af9f-4395-4ae0-bfde-194f59f30edc 57520-0326 HUMAN OTC DRUG
Stomaplex "Carduus marianus, Gentiana lutea, Sambucus nigra"
Company ACTIVATED CHARCOAL; ARSENIC TRIOXIDE; ATROPINE SULFATE; GENTIANA
LUTEA ROOT; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; SAMBUCUS NIGRA FLOWERING TOP
; SENNA LEAF; SILYBUM MARIANUM SEED; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA STOMA
CH 12; 12; 12; 3; 12; 12; 3; 3; 3; 12; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL;
p_X]/mL
57520-0327_d314037f-af7d-4a49-a4ef-39e211f33ce0 57520-0327 HUMAN OTC DRUG
Tobaccotox "Avena sativa, Kali phosphoricum, Cactus grandiflorus, D
aphne indica, Eucalyptol, Lobelia inflata, Mentholum, Ignatia amara, Nux vomica,
Staphysagria, Tabacum, Benzinum, Naphtalinum," LIQUID ORAL 20100511
UNAPPROVED HOMEOPATHIC Apotheca Company "AVENA SATIVA FLOWERING
TOP; BENZENE; DAPHNE ODORA BARK; DELPHINIUM STAPHISAGRIA SEED; EUCALYPTOL; LOBEL
IA INFLATA; MENTHOL; NAPHTHALENE; POTASSIUM PHOSPHATE, DIBASIC; SELENICEREUS GRA
NDIFLORUS STEM; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; TOBACCO LEAF"
57520-0328_1f31021c-e7ac-430e-9053-199631916b98 57520-0328 HUMAN OTC DRUG
Thyroplex "Fucus vesiculosus, Spongia tosta, Iodium, Liothyronine
sodium, Pulsatilla, Glandula suprarenalis bovinum," LIQUID ORAL 20100511
UNAPPROVED HOMEOPATHIC Apotheca Company "BOS TAURUS ADRENAL GLAN
D; FERROUS IODIDE; FUCUS VESICULOSUS; IODINE; LIOTHYRONINE SODIUM; LYCOPUS VIRGI
NICUS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORIC ACID; POTASSIUM IODIDE;
PULSATILLA VULGARIS; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA PITUITAR
Y GLAND; THYROID" 8; 12; 3; 6; 6; 12; 12; 12; 12; 30; 3; 8; 200 [hp_X]/m
57520-0329_3dc12606-c5ba-4f4d-9937-862c3fd5a8a4 57520-0329 HUMAN OTC DRUG
Edemaforce "Cactus grandiflorus, Calendula officinalis, Convallaria
majalis, Dulcamara, Leptandra virginica, Solidago virgaurea, Apis mellifica, Ar
nica montana," LIQUID ORAL 20100426 UNAPPROVED HOMEOPATHIC
Apotheca Company APIS MELLIFERA; ARNICA MONTANA; BERBERIS VULGARIS ROOT B
ARK; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; CHELIDONIUM MAJUS;
CONVALLARIA MAJALIS; CULVER'S ROOT; LEAD; LYCOPODIUM CLAVATUM SPORE; SAMBUCUS NI
GRA FLOWERING TOP; SELENICEREUS GRANDIFLORUS STEM; SOLANUM DULCAMARA TOP; SOLIDA
GO VIRGAUREA FLOWERING TOP 12; 12; 12; 12; 3; 12; 3; 3; 12; 12; 12; 3; 3; 3
57520-0330_246e3d46-e52e-48a2-902b-ba90a91e34f6 57520-0330 HUMAN OTC DRUG
Serotonin Seotonin LIQUID ORAL 20100511
[hp_X]/mL
57520-0331_257046b7-f5de-491b-a8e8-bd57947d7bf9 57520-0331 HUMAN OTC DRUG
Insomnia HP "Arsenicum album, Coffea cruda, Kali carbonicum, Magnesi
a carbonica, Nux vomica, Passiflora incarnata, Sepia, Valeriana officinalis,"
Company ARABICA COFFEE BEAN; ARSENIC TRIOXIDE; MAGNESIUM CARBONATE; PASS
IFLORA INCARNATA TOP; POTASSIUM CARBONATE; SEPIA OFFICINALIS JUICE; STRYCHNOS NU
X-VOMICA SEED; VALERIAN 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [h
57520-0332_0d7a17cf-00fe-4d96-95aa-7b9748e290eb 57520-0332 HUMAN OTC DRUG
Back and Neck Rescue "Hypericum perforatum, Phytolacca decandra, Guai
acum, Ledum palustre, Conium maculatum," GEL TOPICAL 20110520
NG TOP; GUAIACUM OFFICINALE RESIN; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; PH
YTOLACCA AMERICANA ROOT 30; 6; 3; 6; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g;
[hp_X]/g
57520-0333_fda75863-412b-4b6c-9d64-e184ecbd9290 57520-0333 HUMAN OTC DRUG
HCG with Slimming Herbs "Fucus vesiculosus, Cyanocobalamin, Glandula sup
rarenalis suis, Hepar suis, L-carnitine, Ornithine, Antimonium crudum, Human cho
rionic gonadotropin," LIQUID ORAL 20100913 UNAPPROVED HOMEO
PATHIC Apotheca Company "ANTIMONY TRISULFIDE; CYANOCOBALAMIN; FU
CUS VESICULOSUS; HUMAN CHORIONIC GONADOTROPIN; LEVOCARNITINE; ORNITHINE; OYSTER
SHELL CALCIUM CARBONATE, CRUDE; PANCRELIPASE; PORK LIVER; SODIUM SULFATE; SUS SC
ROFA ADRENAL GLAND; SUS SCROFA HYPOTHALAMUS; SUS SCROFA THYROID" 8; 6; 2;
57520-0334_507106fb-525c-4a3e-b773-3676889123e9 57520-0334 HUMAN OTC DRUG
RON AUREUM LEAF; RUTA GRAVEOLENS FLOWERING TOP 6; 12; 3; 6; 12; 12 [hp_X]/g
; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g
57520-0336_f1e42df4-9106-4ba1-a695-c1e0970bda96 57520-0336 HUMAN OTC DRUG
Muscle Ice "Phytolacca deccandra, Symphytum officinale, Bellis pere
nnis, Ledum palustre, Ruta graveolens, Magnesia phosphorica, Silicea," GEL
"BELLIS PERENNIS; COMFREY ROOT; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASI
C TRIHYDRATE; PHYTOLACCA AMERICANA ROOT; RUTA GRAVEOLENS FLOWERING TOP; SILICON
DIOXIDE" 6; 3; 6; 9; 1; 6; 9 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g;
[hp_X]/g; [hp_X]/g; [hp_X]/g
57520-0337_ae27e487-5e54-4536-a981-a03d1bd447ff 57520-0337 HUMAN OTC DRUG
Smart HCG "Human chorionic gonadortopin," LIQUID ORAL 20101110
UNAPPROVED HOMEOPATHIC Apotheca Company HUMAN CHORIONIC GONADOTR
OPIN 60 [hp_X]/mL
57520-0340_831c05ad-762b-46ae-9ad1-6ea14ef64ccc 57520-0340 HUMAN OTC DRUG
HCG Cord HCG (Human chorionic gonadotropin) LIQUID ORAL
HUMAN CHORIONIC GONADOTROPIN 200 [hp_C]/mL
57520-0341_43c2aa9a-e1cd-41b9-bf7e-cc02880167a7 57520-0341 HUMAN OTC DRUG
HCG Cord HCG (Human chorionic gonadotropin) SPRAY ORAL
HUMAN CHORIONIC GONADOTROPIN 34 [hp_C]/mL
57520-0342_9da945c6-f8ee-4410-8106-fffb0c872d98 57520-0342 HUMAN OTC DRUG
Norepinephrine Norepinephrine LIQUID ORAL 20100426
UNAPPROVED HOMEOPATHIC Apotheca Company NOREPINEPHRINE 30
[hp_C]/mL
57520-0343_559f2e7f-7372-4766-b130-f86d4701136d 57520-0343 HUMAN OTC DRUG
Mold Mix Antigens "Arsenicum album, Phosphorus, Pulsatilla, Sepia,
Alternaria tenuis, Aspergillus niger, Rhizopus nigricans," LIQUID ORAL
ALTERNARIA ALTERNATA; ARSENIC TRIOXIDE; ASPERGILLUS NIGER VAR. NIGER; AUREOBASID
IUM PULLULANS VAR. PULLUTANS; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; MUCOR RACE
MOSUS; PHOSPHORUS; PULSATILLA VULGARIS; RHIZOPUS STOLONIFER; SACCHAROMYCES CEREV
ISIAE; SEPIA OFFICINALIS JUICE 200; 12; 200; 200; 200; 200; 200; 12; 12; 200; 2
57520-0345_164f2e8b-a58d-4fb7-8c14-f97a63f9ffd4 57520-0345 HUMAN OTC DRUG
Sinuchron "Arsenicum album, Hepar sulphuris calcareum, Hydrastis c
anadensis, Kali bichromicum, Lycopodium clavatum, Mercurius solubilis, Natrum mu
riaticum" LIQUID ORAL 20100427 UNAPPROVED HOMEOPATHIC
Apotheca Company ARSENIC TRIOXIDE; CALCIUM SULFIDE; GOLDENSEAL; LYCOPODIU
M CLAVATUM SPORE; MERCURIUS SOLUBILIS; PHOSPHORUS; POTASSIUM DICHROMATE; PULSATI
LLA VULGARIS; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE; THUJA OCCIDENTALIS TWIG
30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL;
p_X]/mL
57520-0346_5176bd87-c35a-43df-8e1f-33a7bcfa0775 57520-0346 HUMAN OTC DRUG
Endopar M "Aralia racemosa, Sabal serrulata, Glandula suprarenalis, Orchit
inum, Pituitaria Glandula, Prostate, Agnus castus," LIQUID ORAL 20100504
UNAPPROVED HOMEOPATHIC Apotheca Company ARALIA RACEMOSA ROOT; CH
ASTE TREE; CLEMATIS RECTA FLOWERING TOP; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS;
SAW PALMETTO; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA P
ROSTATE; SUS SCROFA TESTICLE; THUJA OCCIDENTALIS LEAFY TWIG 3; 12; 12; 12; 1
57520-0347_b9bd68a6-86f9-4e36-8981-b77627635d70 57520-0347 HUMAN OTC DRUG
Bronchi HP "Carbo vegetabilis, Cuprum metallicum, Drosera Rotundifolia"
Company "ACTIVATED CHARCOAL; CALCIUM SULFIDE; COPPER; DROSERA ROTUNDIFOL
IA; IPECAC; LACHESIS MUTA VENOM; LOBELIA INFLATA; PHOSPHORUS; PULSATILLA VULGARI
S; RUMEX CRISPUS ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED" 30; 30; 30; 30;
57520-0348_4cc5bae8-d9f5-43f6-ab2a-72a8d7caea0d 57520-0348 HUMAN OTC DRUG
Thymupar "Baptisia tinctoria, Echinacea, Hydrastis canadensis"
Company ARSENIC TRIOXIDE; ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; CA
LCIUM SULFIDE; ECHINACEA; GOLDENSEAL; IRIDIUM; LACHESIS MUTA VENOM; THYMUS
57520-0349_5e209dde-2290-48bd-b3a0-25726d3a89bb 57520-0349 HUMAN OTC DRUG
Colosode "Taraxacum officinale, Berberis vulgaris, Rhamnus purshi
ana, Rheum, Cina, Arsenicum album, Aloe socotrina, Colostrum, Gallbladder, Hepar
bovinum," LIQUID ORAL 20100929 UNAPPROVED HOMEOPATHIC
Apotheca Company ACTIVATED CHARCOAL; ALOE; ARANEUS DIADEMATUS; ARSENIC TR
IOXIDE; ARTEMISIA CINA FLOWER; BEEF LIVER; BERBERIS VULGARIS ROOT BARK; BOTULINU
M TOXIN TYPE A; CARBO ANIMALIS; CLOSTRIDIUM PERFRINGENS; COLOSTRUM HUMAN; ENTERO
COCCUS FAECALIS; ESCHERICHIA COLI; FRANGULA PURSHIANA BARK; GIARDIA LAMBLIA; IND
OLE; LACTOBACILLUS ACIDOPHILUS; MANDRAGORA OFFICINARUM ROOT; MERCURIUS SOLUBILIS
; PORK INTESTINE; PROTEUS MIRABILIS; PSEUDOMONAS AERUGINOSA; RHEUM OFFICINALE RO
OT; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SELENIUM; SUS SCROF
A GALLBLADDER; SUS SCROFA GALLBLADDER; TARAXACUM OFFICINALE; VERATRUM ALBUM ROOT
; YERSINIA ENTEROCOLITICA 30; 30; 12; 6; 12; 12; 3; 60; 12; 60; 8; 12; 32;
3; 200; 200; 15; 12; 12; 30; 60; 60; 3; 60; 12; 12; 12; 1; 12; 60 [hp_X]/m
[hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp
57520-0350_053cbe6f-b5f9-4b60-a683-fc24cf7285f3 57520-0350 HUMAN OTC DRUG
Gold "L-carnitine, L-glutamine, L-ornithine, L-tryptophan, L-tryosine
, Human chorionic gonadotropin," LIQUID ORAL 20100930
UNAPPROVED HOMEOPATHIC Apotheca Company GLUTAMINE; HUMAN CHORION
IC GONADOTROPIN; LEVOCARNITINE; ORNITHINE; TRYPTOPHAN; TYROSINE 6; 60; 6; 6; 6;
6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0351_d0bb8ac9-720d-4b67-9337-f507693656d5 57520-0351 HUMAN OTC DRUG
Platinum For Women "Cyanocobalamin, Glandula suprarenalis suis, Kal
i carbonicum, L-carnitine, L-glutamine, L-ornithine, L-tryptophan, L-tryosine, O
ophorinum," LIQUID ORAL 20101001 UNAPPROVED HOMEOPATHIC
Apotheca Company "CYANOCOBALAMIN; GLUTAMINE; HUMAN CHORIONIC GONADOTROPIN
; LEVOCARNITINE; ORNITHINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM CAR
BONATE; SUS SCROFA ADRENAL GLAND; SUS SCROFA OVARY; SUS SCROFA THYROID; TRYPTOPH
AN; TYROSINE" 6; 6; 60; 6; 6; 12; 6; 6; 6; 8; 6; 6 [hp_X]/mL; [hp_X]/mL; [h
57520-0352_348e14a2-cc38-4038-8c5a-82da9a3f6bcf 57520-0352 HUMAN OTC DRUG
Lyme HP "Baptisia tinctoria, Echinacea, Hydrastis canadensis, Arsenicum
album, Bryonia, Chelidonium majus, Colchicum autumnale Kalmia latifolia,"
Company ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BORRELIA BURGDORFERI;
BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; COLCHICUM AUTUMNALE BULB; ECHINACEA; GOLD
ENSEAL; KALMIA LATIFOLIA LEAF; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; P
HOSPHORUS; TOXICODENDRON PUBESCENS LEAF 30; 3; 200; 30; 30; 30; 3; 3; 30; 30; 30
; 30; 30 [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL
; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL
57520-0353_96c50b73-d188-4152-9723-bf04e8cb2062 57520-0353 HUMAN OTC DRUG
Psoriasis HP "Arsenicum album, Borax, Graphites, Natrum muriaticum, S
epia, Sulphur," LIQUID ORAL 20101110 UNAPPROVED HOMEOPATHIC
Apotheca Company ARSENIC TRIOXIDE; GRAPHITE; SEPIA OFFICINALIS JUICE; SOD
IUM BORATE; SODIUM CHLORIDE; SULFUR 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X
57520-0355_da12de21-eba2-4347-baf2-d7a776759af8 57520-0355 HUMAN OTC DRUG
Gastrotone "Gentiana lutea, Sambucus nigra, Arsenicum album, Kali b
ichromicum, Lycopodium clavatum, Phosphorus, Pulsatilla Bismuthum carbonicum,"
Company ARSENIC TRIOXIDE; BISMUTH SUBCARBONATE; GENTIANA LUTEA ROOT; LYC
OPODIUM CLAVATUM SPORE; PHOSPHORUS; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; S
AMBUCUS NIGRA FLOWERING TOP 12; 15; 3; 12; 12; 12; 12; 3 [hp_X]/mL; [hp_X
]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0356_f98cb631-685a-489b-ae97-225cda2e01e9 57520-0356 HUMAN OTC DRUG
ADD HP "Gamma-aminobutyric acid, L-dopa, Norepinephrine, Serotonin, Adr
enocorticotropin, Anacardium orientale, Arsenicum album, Baryta carbonica, Calca
rea carbonica, Calcarea phosphorica, Hyoscyamus niger, Ly" LIQUID ORAL
".GAMMA.-AMINOBUTYRIC ACID; ARSENIC TRIOXIDE; BARIUM CARBONATE; CORTICOTROPIN; D
ATURA STRAMONIUM; HYOSCYAMUS NIGER; LEVODOPA; LYCOPODIUM CLAVATUM SPORE; NOREPIN
EPHRINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SEMECARPUS ANACARDIUM JUICE; SER
OTONIN; TRIBASIC CALCIUM PHOSPHATE" 30; 30; 30; 30; 30; 30; 30; 30; 30; 30;
; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL
57520-0357_9affe0a1-3f3a-4e5a-8256-2682ab3d63ab 57520-0357 HUMAN OTC DRUG
Fungustat I "Echinacea, Tabebuia impetiginosa, Abies nigra, Lycopodi
um clavatum, Nux vomica, Phosphorus, Pulsatilla," LIQUID ORAL 20100429
UNAPPROVED HOMEOPATHIC Apotheca Company CANDIDA ALBICANS; ECHINA
CEA; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PICEA MARIANA RESIN; PULSATILLA VULG
ARIS; SEPIA OFFICINALIS JUICE; SKATOLE; STRYCHNOS NUX-VOMICA SEED; TABEBUIA IMPE
TIGINOSA BARK 30; 3; 12; 12; 12; 12; 12; 15; 12; 3 [hp_X]/mL; [hp_X]/mL; [h
]/mL
57520-0360_e34eafbf-81a9-438a-9425-230e98671e17 57520-0360 HUMAN OTC DRUG
Anas Barbariae Anas Barbariae LIQUID ORAL 20100430
UNAPPROVED HOMEOPATHIC Apotheca Company CAIRINA MOSCHATA HEART/L
IVER AUTOLYSATE 200 [hp_C]/mL
57520-0362_57075482-7194-4ff6-b029-768bb3ff7948 57520-0362 HUMAN OTC DRUG
Salmonella Salmonella LIQUID ORAL 20100503
UNAPPROVED HOMEOPATHIC Apotheca Company SALMONELLA ENTERICA SUBS
P. ENTERICA SEROVAR ENTERITIDIS 30 [hp_X]/mL
57520-0363_a2b4738b-db33-4f58-80b6-e5fc163f3043 57520-0363 HUMAN OTC DRUG
Tinnitus DX "Calcarea carbonica, Carbo vegetabilis, Chininum sulphur
icum, Cimicifuga racemosa, Cinchona officinalis, Coffea cruda, Graphites, Kali c
arbonicum," CAPSULE ORAL 20101112 UNAPPROVED HOMEOPATHIC
Apotheca Company "ACTIVATED CHARCOAL; ARABICA COFFEE BEAN; BLACK COHOSH;
CINCHONA OFFICINALIS BARK; GRAPHITE; LYCOPODIUM CLAVATUM SPORE; OYSTER SHELL CAL
CIUM CARBONATE, CRUDE; POTASSIUM CARBONATE; QUININE SULFATE; SALICYLIC ACID; SOD
IUM SALICYLATE" 30; 12; 30; 30; 30; 30; 30; 30; 30; 6; 6 [hp_X]/1; [hp_X]
/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]
/1; [hp_X]/1
57520-0364_373a0ca9-8490-405f-8d6c-a188c44751e4 57520-0364 HUMAN OTC DRUG
Cherry Plum Cherry plum LIQUID ORAL 20100430
UNAPPROVED HOMEOPATHIC Apotheca Company PRUNUS CERASIFERA FLOWER
30 [hp_C]/mL
57520-0365_7794dfb9-effe-4609-b3bd-24c7ed16f527 57520-0365 HUMAN OTC DRUG
Oak "Oak," LIQUID ORAL 20100503 UNAPPROVED HOMEO
PATHIC Apotheca Company QUERCUS ROBUR FLOWER 30 [hp_C]/m
L
57520-0366_e03cff3f-c468-42aa-a5f7-76ab697bf2dc 57520-0366 HUMAN OTC DRUG
Rock Water Rock water LIQUID ORAL 20100503
UNAPPROVED HOMEOPATHIC Apotheca Company WATER 30 [hp_C]/m
L
57520-0367_90e83056-3284-4769-b2cd-6a7c4a4918ea 57520-0367 HUMAN OTC DRUG
Ferrum Phos Ferrum phosphoricum LIQUID ORAL 20100503
UNAPPROVED HOMEOPATHIC Apotheca Company FERRUM PHOSPHORICUM
30 [hp_C]/mL
57520-0368_8689b716-9652-4f60-b0cf-41da342c6f17 57520-0368 HUMAN OTC DRUG
Sepia Sepia LIQUID ORAL 20100503 UNAPPROVED HOMEO
PATHIC Apotheca Company SEPIA OFFICINALIS JUICE 30 [hp_C]/m
L
57520-0369_fbad7b62-a9b9-4495-94eb-4285e15c80c3 57520-0369 HUMAN OTC DRUG
Thyroid "Baryta carbonica, Calcarea carbonica, Calcarea iodata" LIQUID
"BARIUM CARBONATE; CALCIUM IODIDE; FUCUS VESICULOSUS; IODINE; OYSTER SHELL CALCI
UM CARBONATE, CRUDE; PULSATILLA VULGARIS; SODIUM CHLORIDE; SPONGIA OFFICINALIS S
KELETON, ROASTED; THYROID" 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/m
[hp_X]/mL
57520-0370_9fc1f686-5f06-445b-9b62-9a76bac7598b 57520-0370 HUMAN OTC DRUG
Liver Gallbladder "Belladonna, Carduus marianus, Chelidonium majus
, Colocynthis, Lycopodium clavatum, Natrum sulphuricum, Nux vomica, Phosphorus,
Pulsatilla, Veratrum album" LIQUID ORAL 20100430 UNAPPROV
ED HOMEOPATHIC Apotheca Company ATROPA BELLADONNA; CHELIDONIUM M
AJUS; CITRULLUS COLOCYNTHIS FRUIT PULP; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; P
ULSATILLA VULGARIS; SILYBUM MARIANUM SEED; SODIUM SULFATE; STRYCHNOS NUX-VOMICA
SEED; VERATRUM ALBUM ROOT 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/m
57520-0372_06d4c68f-b5a8-4686-abe9-4e8b920929b4 57520-0372 HUMAN OTC DRUG
L Dopa Phenolic L-dopa LIQUID ORAL 20100429 UNAPPROV
ED HOMEOPATHIC Apotheca Company LEVODOPA 30 [hp_C]/m
L
57520-0373_ba24ceb4-e6ed-4c3e-a1fa-fd9de166d65a 57520-0373 HUMAN OTC DRUG
Mold Antigens "Arsenicum album, Phosphorus, Pulsatilla, Sepia, Alterna
ria tenuis, Aspergillus niger, Rhizopus nigricans, Mucor racemosus, Pullularia p
ullulans, Candida albicans, Candida parapsilosis, Torula cerevisi" LIQUID
ALTERNARIA ALTERNATA; ARSENIC TRIOXIDE; ASPERGILLUS NIGER VAR. NIGER; AUREOBASID
IUM PULLULANS VAR. PULLUTANS; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; MUCOR RACE
MOSUS; PHOSPHORUS; PULSATILLA VULGARIS; RHIZOPUS STOLONIFER; SACCHAROMYCES CEREV
ISIAE RNA; SEPIA OFFICINALIS JUICE 200; 30; 200; 200; 200; 200; 200; 30; 30
57520-0374_6fc4776f-36a3-440f-9abf-8da18314477e 57520-0374 HUMAN OTC DRUG
Anxiety "Arsenicum album, Calcarea carbonica, Ignatia amara, Kali carbon
icum, Lachesis mutus, Natrum muriaticum, Phosphorus, Pulsatilla, Staphysagria"
Company "ARSENIC TRIOXIDE; DELPHINIUM STAPHISAGRIA SEED; LACHESIS MUTA V
ENOM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; POTASSIUM CARBONATE; PU
LSATILLA VULGARIS; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED" 30; 30; 30; 30;
57520-0375_c0af72aa-bfd6-4e9e-b206-eee04b27fd1e 57520-0375 HUMAN OTC DRUG
Bone Repair HP "Calcarea carbonica, Calcarea Fluorica, Calcarea phospho
rica, Hekla lava, Hydrofluoricum acidum, Magnesia phosphorica Rhus toxicodendron
, Ruta graveolens, Silicea, Symphytum officinale" LIQUID ORAL 20100430
UNAPPROVED HOMEOPATHIC Apotheca Company "CALCIUM FLUORIDE; COMFR
EY ROOT; HEKLA LAVA; HYDROFLUORIC ACID; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE;
OYSTER SHELL CALCIUM CARBONATE, CRUDE; RUTA GRAVEOLENS FLOWERING TOP; SILICON D
IOXIDE; TOXICODENDRON PUBESCENS LEAF; TRIBASIC CALCIUM PHOSPHATE" 30; 30;
57520-0376_db355a8f-887d-4206-89e9-fb9012d0be04 57520-0376 HUMAN OTC DRUG
Cold "Aconitum napellus, Allium cepa, Eupatorium perfoliatum, Ferrum
phosphoricum, Gelsemium sempervirens, Kali bichromicum, Nercurius solubilis, Nux
vomica, Pulsatilla" LIQUID ORAL 20100430 UNAPPROVED HOMEO
PATHIC Apotheca Company ACONITUM NAPELLUS; EUPATORIUM PERFOLIATU
M FLOWERING TOP; FERRUM PHOSPHORICUM; GELSEMIUM SEMPERVIRENS ROOT; MERCURIUS SOL
UBILIS; ONION; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; STRYCHNOS NUX-VOMICA S
EED 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL;
57520-0377_ee09401b-0b40-493e-bb6e-6656842c1496 57520-0377 HUMAN OTC DRUG
Allerpoll "Allium cepa, Ambrosia artemisiaefolia, Apis mellifica"
Company AMBROSIA ARTEMISIIFOLIA; APIS MELLIFERA; ARSENIC TRIOXIDE; EUPHR
ASIA STRICTA; ONION; PHOSPHORUS; PULSATILLA VULGARIS; SOLIDAGO VIRGAUREA FLOWERI
NG TOP; STRYCHNOS NUX-VOMICA SEED; SULFUR 30; 30; 30; 30; 30; 30; 30; 30;
57520-0378_732b1bcb-def6-4eb1-99d0-b2fb3bb6886d 57520-0378 HUMAN OTC DRUG
Gaba Phenolic Gamma-aminobutyric acid LIQUID ORAL 20100503
UNAPPROVED HOMEOPATHIC Apotheca Company .GAMMA.-AMINOBUTYRIC ACI
D 30 [hp_C]/mL
57520-0381_06b15025-3a37-4268-8714-26ae933cf851 57520-0381 HUMAN OTC DRUG
Pancreapar "Hydrastis canadensis, Syzgium jambolanum, Glandula supr
arenalis, Pancreas, Pituitaris glandula Phaseolus," LIQUID ORAL 20100507
UNAPPROVED HOMEOPATHIC Apotheca Company "ACETIC ACID; GOLDENSEAL
; KIDNEY BEAN; LACTIC ACID, DL-; PHOSPHORIC ACID; PHOSPHORUS; SUS SCROFA ADRENAL
GLAND; SUS SCROFA PANCREAS; SUS SCROFA PITUITARY GLAND; SYZYGIUM CUMINI SEED; U
RANYL NITRATE HEXAHYDRATE" 12; 3; 9; 12; 12; 12; 6; 6; 6; 3; 12 [hp_X]/m
57520-0382_e0719005-fdad-486f-bdba-13fc23fb6bfd 57520-0382 HUMAN OTC DRUG
HCG Select Female Vitality Formula "Fucus vesiculosus, Cyanocobalam
in, Glandula suprarenalis suis, Hepar suis, Oophorinum, Human chorionic gonadotr
opin," LIQUID ORAL 20100901 UNAPPROVED HOMEOPATHIC
Apotheca Company CYANOCOBALAMIN; FUCUS VESICULOSUS; GRAPHITE; HUMAN CHORI
ONIC GONADOTROPIN; PANCRELIPASE; PORK LIVER; SUS SCROFA ADRENAL GLAND; SUS SCROF
A HYPOTHALAMUS; SUS SCROFA OVARY; SUS SCROFA THYROID; THUJA OCCIDENTALIS LEAFY T
WIG 6; 2; 12; 60; 12; 6; 6; 18; 6; 8; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL;
p_X]/mL
57520-0383_960ede38-d8a1-434f-9d81-00e3d1718cf8 57520-0383 HUMAN OTC DRUG
Passion Drops "Agnus castus, Lachesis mutus, Lycopodium clavatum, Natr
um muriaticum, Nux vomica, Phosphoricum acidum, Phosphorus, Pulsatilla, Sepia,"
LOZENGE ORAL 20110415 UNAPPROVED HOMEOPATHIC Apotheca
Company CHASTE TREE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; PHO
SPHORIC ACID; PHOSPHORUS; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SODIUM C
HLORIDE; STRYCHNOS NUX-VOMICA SEED 9; 9; 9; 9; 9; 9; 9; 9; 9 [hp_C]/1
; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1
57520-0384_c54bb312-aa8b-4e6e-9d15-4b620db78a6f 57520-0384 HUMAN OTC DRUG
Bio Star of Bethlehem "Star of bethlehem," LIQUID ORAL 20101111
UNAPPROVED HOMEOPATHIC Apotheca Company ORNITHOGALUM UMBELLATUM
200 [hp_C]/mL
57520-0385_a0a168d2-adb3-4de7-9f40-d9bfa591214f 57520-0385 HUMAN OTC DRUG
Relax "Histaminum hydrochloricum, Dopamine, Kidney, L-theanine, Penyle
thylamine hydrochloricum," SPRAY ORAL 20101230 UNAPPROV
ED HOMEOPATHIC Apotheca Company DOPAMINE; HISTAMINE DIHYDROCHLOR
IDE; PHENETHYLAMINE HYDROCHLORIDE; PORK KIDNEY; THEANINE 12; 6; 24; 12; 1
2 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL
57520-0386_9cc82786-d11e-4404-b80c-50ffecbee270 57520-0386 HUMAN OTC DRUG
Emotional Balance "Rauwolfia serpentina," SPRAY ORAL 20101230
UNAPPROVED HOMEOPATHIC Apotheca Company RAUWOLFIA SERPENTINA
24 [hp_C]/mL
57520-0387_8037ebe4-249d-4d7a-b19d-9706bed2650b 57520-0387 HUMAN OTC DRUG
hCG Detox "Human chorionic gonadotropin (hCG)," LIQUID ORAL
HUMAN CHORIONIC GONADOTROPIN 60 [hp_X]/mL
57520-0388_e21b31df-a2fc-4040-8d05-e6f8d189769c 57520-0388 HUMAN OTC DRUG
Arnica Drops "Arnica montana," LOZENGE ORAL 20110415
UNAPPROVED HOMEOPATHIC Apotheca Company ARNICA MONTANA 30
[hp_X]/1
57520-0389_8930fb91-6a13-4f83-bf11-51ce9737958a 57520-0389 HUMAN OTC DRUG
Ligatone "Arnica montana, Bryonia alba, Causticum, Calcarea phosp
horica, Kali carbonicum, Manganese gluconate, Mezereum, Rhus toxidocendron,"
Company ARNICA MONTANA; BRYONIA ALBA ROOT; CAUSTICUM; DAPHNE MEZEREUM BA
RK; MANGANESE GLUCONATE; POTASSIUM CARBONATE; RUTA GRAVEOLENS FLOWERING TOP; SIL
ICON DIOXIDE; SUS SCROFA TENDON; TOXICODENDRON PUBESCENS LEAF; TRIBASIC CALCIUM
PHOSPHATE 12; 12; 12; 12; 12; 12; 12; 12; 8; 12; 12 [hp_X]/mL; [hp_X
]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/m
57520-0390_a29600c8-b806-4f51-b664-da8b49f7e91a 57520-0390 HUMAN OTC DRUG
Night Shade Antigen "Chili pepper, Green pepper, Potato, Tobacco, To
mato, Eggplant, Nux vomica, Pulsatilla," LIQUID ORAL 20100804
UNAPPROVED HOMEOPATHIC Apotheca Company ALUMINUM; ARSENIC TRIOXI
DE; CAPSICUM; EGGPLANT; GREEN BELL PEPPER; PHOSPHORUS; POTATO; PULSATILLA VULGAR
IS; STRYCHNOS NUX-VOMICA SEED; TOBACCO LEAF; TOMATO 12; 12; 30; 30; 30; 12;
57520-0391_08268a0b-dc44-4ba0-abbf-e73af0f80de6 57520-0391 HUMAN OTC DRUG
Muscle Matrix "Arginine, L-carnitine, Ornithine," LIQUID ORAL
ARGININE; LEVOCARNITINE; ORNITHINE 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [h
p_X]/mL
57520-0392_cf76db10-20e5-4a5f-805f-faf52daa2dd5 57520-0392 HUMAN OTC DRUG
Arnica Plus "Arnia montana, Hamamelis virginiana, Rhus toxicodendron
," GEL TOPICAL 20110308 UNAPPROVED HOMEOPATHIC
; TOXICODENDRON PUBESCENS LEAF 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0393_32b9ad34-c7f2-4f30-b2f2-29f3e1b2647e 57520-0393 HUMAN OTC DRUG
YTOLACCA AMERICANA ROOT 30; 6; 3; 6; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/
mL; [hp_X]/mL
57520-0394_230817dc-8771-4a34-a531-42ea0f91e899 57520-0394 HUMAN OTC DRUG
RON AUREUM LEAF; RUTA GRAVEOLENS FLOWERING TOP 6; 12; 3; 6; 12; 12 [hp_X]/m
57520-0395_3ddf4db9-92ee-4691-8eda-3453ac23049e 57520-0395 HUMAN OTC DRUG
Muscle Ice "Phytolacca decandra, Symphytum officinale, Bellis peren
nis, Ledum palustre, Ruta graveolens, Magnesia phosphorica, Silicea," GEL
57520-0396_528b4ced-69f9-4c42-a257-dc4a0a0e01df 57520-0396 HUMAN OTC DRUG
Muscle Rescue "Arnica montana, Rhus Toxicodendron, Phytolacca decandra
, Pulsatilla, Ruta graveolens," GEL TOPICAL 20110520 UNAPPROV
ED HOMEOPATHIC Apotheca Company ARNICA MONTANA; PHYTOLACCA AMERI
CANA ROOT; PULSATILLA VULGARIS; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUB
ESCENS LEAF 3; 12; 12; 12; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g;
[hp_X]/g
57520-0398_c3e70690-16e5-4dad-8f29-16b6a6f82e81 57520-0398 HUMAN OTC DRUG
Zyvestra "Cocculus indicus, Ferrum metallicum, Gelsemium sempervi
rens, Phytolacca decandra, Pulsatilla, Silicea," TABLET ORAL 20101203
UNAPPROVED HOMEOPATHIC Apotheca Company ANAMIRTA COCCULUS SEED;
GELSEMIUM SEMPERVIRENS ROOT; IRON; PHYTOLACCA AMERICANA ROOT; SILICON DIOXIDE
55; 55; 55; 55; 55 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
57520-0399_439c006f-c5d3-4143-b611-ec6e719ca0e4 57520-0399 HUMAN OTC DRUG
Tendon Rescue "Bryonia, Ruta graveolens, Bellis perennis, Argentum met
allicum," GEL TOPICAL 20110224 UNAPPROVED HOMEOPATHIC
ERING TOP; SILVER 6; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/
mL
57520-0401_5a5d4db8-421a-4837-aedd-920257b2754b 57520-0401 HUMAN OTC DRUG
Acetylcholine Chloride Phenolic "Acetylcholine chloride," LIQUID
ACETYLCHOLINE CHLORIDE 30 [hp_C]/mL
57520-0402_264ff3cb-5231-4cc2-96bf-0ed4f1f2e152 57520-0402 HUMAN OTC DRUG
Nausea Vomiting HP "Aethusa cynapium, Arsenicum album, Cocculus ind
icus, Ipecacuanha, Kreosotum, Petroleum, Pulsatilla, Sanguinaria canadensis, Tab
acum," LIQUID ORAL 20100507 UNAPPROVED HOMEOPATHIC
Apotheca Company AETHUSA CYNAPIUM; ANAMIRTA COCCULUS SEED; ARSENIC TRIOXI
DE; IPECAC; KEROSENE; PULSATILLA VULGARIS; SANGUINARIA CANADENSIS ROOT; TOBACCO
LEAF; WOOD CREOSOTE 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X
L
57520-0403_f8ef92e3-30a6-41a1-a67f-11c41bd765d9 57520-0403 HUMAN OTC DRUG
Quercetin Phenolic "Quercetin," LIQUID ORAL 20100510
UNAPPROVED HOMEOPATHIC Apotheca Company QUERCETIN 30
[hp_C]/mL
57520-0404_eb3d9ff6-7f4c-4068-aabe-406e6ced5ffa 57520-0404 HUMAN OTC DRUG
Progesterone Phenolic "Progesterone," LIQUID ORAL 20100510
[hp_C]/mL
57520-0405_557342b8-9ec9-49d5-9565-3466c0e697bd 57520-0405 HUMAN OTC DRUG
Artalgia "Carduus marianus, Arnica montana, Agaricus muscarius, B
aryta carbonica, Bellis perennis, Glonoinum, Hamamelis virginiana, Mercurius sol
ubilis, Plumbum metallicum, Secale cornutum, Vanadium metallicum," LIQUID
ACTIVATED CHARCOAL; AMANITA MUSCARIA VAR. MUSCARIA; ARNICA MONTANA; ARNICA MONTA
NA; BARIUM CARBONATE; BELLIS PERENNIS; CLAVICEPS PURPUREA SCLEROTIUM; HAMAMELIS
VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; LEAD; MERCURIUS SOLUBILIS;
NITROGLYCERIN; PHOSPHORUS; PULSATILLA VULGARIS; SILYBUM MARIANUM SEED; TOXICODE
NDRON PUBESCENS LEAF; VANADIUM 30; 12; 12; 3; 12; 12; 12; 12; 30; 12; 12; 12; 3
57520-0406_e27b57de-957d-4b21-82a5-6b5a45232669 57520-0406 HUMAN OTC DRUG
Star of Bethlehem Star-of-Bethlehem LIQUID ORAL 20100521
UNAPPROVED HOMEOPATHIC Apotheca Company ORNITHOGALUM UMBELLATUM
30 [hp_C]/mL
57520-0407_384a3edd-b7ce-4337-b930-5cfb2a94e72b 57520-0407 HUMAN OTC DRUG
PMS Tone "Angelica archangelica, Cimicifuga racemosa," LIQUID
ANGELICA ARCHANGELICA ROOT; BLACK COHOSH; CANIS LUPUS FAMILIARIS MILK; COPPER; F
UCUS VESICULOSUS; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VUL
GARIS; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE 3; 3; 12; 12; 3; 12; 12; 12; 12;
57520-0409_fc0ff145-1ec5-409e-babf-7fdd080e6dbc 57520-0409 HUMAN OTC DRUG
Anxiety "Aconitum napellus, Arsenicum album, Belladonna, Calcarea carbon
ica, Carcinosin, Causticum, Gelsemium sempervirens, Lachesis mutus," SPRAY
"ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; CAUSTICUM; GELSEMIUM SE
MPERVIRENS ROOT; HUMAN BREAST TUMOR CELL; HUMAN BREAST TUMOR CELL; LACHESIS MUTA
VENOM; MERCURY; NITRIC ACID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS;
TOXICODENDRON PUBESCENS LEAF" 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30;
/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL
57520-0410_c3309fcb-e48c-4357-a781-9439c6f20d1d 57520-0410 HUMAN OTC DRUG
Thyrostat "Fucus vesiculosus, Spongia tosta, Pituitaria glandula,
Thyroidinum, Arsenicum iodatum," LIQUID ORAL 20100517
UNAPPROVED HOMEOPATHIC Apotheca Company "ARSENIC TRIIODIDE; BARI
UM CARBONATE; FUCUS VESICULOSUS; IODINE; LYCOPUS VIRGINICUS; OYSTER SHELL CALCIU
M CARBONATE, CRUDE; SODIUM CHLORIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS
SCROFA PITUITARY GLAND; THYROID" 12; 12; 3; 12; 12; 12; 12; 3; 6; 6
57520-0411_80aeca4f-f7b8-427f-8bf2-75f6a9fe800f 57520-0411 HUMAN OTC DRUG
Bronchitone "Echinacea, Lobelia inflata, Antimonium tartaricum, Aral
ia racemosa, Drosera, Ipecacuanha, Kali Carbonicum, Phosphorus, Spongia tosta"
Company "ANTIMONY POTASSIUM TARTRATE; ARALIA RACEMOSA ROOT; DROSERA ROTU
NDIFOLIA; ECHINACEA; IPECAC; LOBELIA INFLATA; PHOSPHORUS; POTASSIUM CARBONATE; S
PONGIA OFFICINALIS SKELETON, ROASTED" 12; 12; 12; 3; 12; 3; 12; 12; 12
_X]/mL; [hp_X]/mL
57520-0412_259286e6-d7e0-49c3-8027-c12f3b492cc7 57520-0412 HUMAN OTC DRUG
HZ HP "Lycopodium clavatum, Mezereum, Natrum acidum, Ranunculus bulbos
us, Rhus Toxicodendron, Sepia, Thuja occidentalis" LIQUID ORAL 20100517
UNAPPROVED HOMEOPATHIC Apotheca Company DAPHNE MEZEREUM BARK; LY
COPODIUM CLAVATUM SPORE; NITRIC ACID; RANUNCULUS BULBOSUS; SEPIA OFFICINALIS JUI
CE; SODIUM CHLORIDE; THUJA OCCIDENTALIS TWIG; TOXICODENDRON PUBESCENS LEAF
57520-0413_bf47ad4a-c1a8-4ff8-a1f7-5ff5308c5018 57520-0413 HUMAN OTC DRUG
Hepapar "Carduus marianus, Chelidonium majus, Taraxacum officinale"
Company CHELIDONIUM MAJUS; CHENOPODIUM AMBROSIOIDES; LYCOPODIUM CLAVATUM
SPORE; MERCURIUS SOLUBILIS; PHOSPHORUS; PORK LIVER; SILYBUM MARIANUM SEED; SODI
UM SULFATE; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE 3; 6; 12; 12; 12
57520-0414_89486a2b-24b3-4439-83de-9df84c0a312c 57520-0414 HUMAN OTC DRUG
ALZ HP "Anacardium orientale, Belladonna, Hyoscyamus" LIQUID ORAL
ATROPA BELLADONNA; BARIUM CARBONATE; DATURA STRAMONIUM; HYOSCYAMUS NIGER; LACHES
IS MUTA VENOM; PHOSPHORUS; POTASSIUM BROMIDE; SEMECARPUS ANACARDIUM JUICE; VERAT
RUM ALBUM ROOT 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_C]/mL; [h
p_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0415_a7f7f45f-7ebd-4634-bbf8-ec5a50dbbd04 57520-0415 HUMAN OTC DRUG
Gastropanpar "Pancreas, Stomach, Arsenicum album, Graphites, Lycopodi
um clavatum, Nux vomica, Phosphorus, Syzygium jambolanum," LIQUID ORAL
ARSENIC TRIOXIDE; GRAPHITE; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; STRYCHNOS NUX
-VOMICA SEED; SUS SCROFA PANCREAS; SUS SCROFA STOMACH; SYZYGIUM CUMINI SEED
57520-0416_163628d9-5349-44ed-9890-c8d0df625d66 57520-0416 HUMAN OTC DRUG
Asthma HP "Arsenicum album, Belladonna, Blatta orientalis, Ipecacuanha, Ka
li carbonicum, Lobelia inflata, Natrum sulphuricum, Silicea" LIQUID ORAL
ARSENIC TRIOXIDE; ATROPA BELLADONNA; BLATTA ORIENTALIS; IPECAC; LOBELIA INFLATA;
POTASSIUM CARBONATE; SILICON DIOXIDE; SODIUM SULFATE 30; 30; 30; 30; 30; 30;
/mL; [hp_X]/mL
57520-0417_30ba16dc-4dc2-4568-8d4b-028f846e2e99 57520-0417 HUMAN OTC DRUG
Cystotone "Sarsaparilla, Uva-ursi, Arsenicum album, Cantharis, Par
eira brava, Pulsatilla, Sepia, Terebinthina, Populus tremuloides" LIQUID
ARCTOSTAPHYLOS UVA-URSI LEAF; ARSENIC TRIOXIDE; CHONDRODENDRON TOMENTOSUM ROOT;
LYTTA VESICATORIA; POPULUS TREMULOIDES LEAF; PULSATILLA VULGARIS; SARSAPARILLA;
SEPIA OFFICINALIS JUICE; TURPENTINE 3; 12; 12; 12; 15; 12; 3; 12; 12
_X]/mL; [hp_X]/mL
57520-0418_9da142fc-8c52-4410-8cfd-b496ebe3a11d 57520-0418 HUMAN OTC DRUG
Allerstat I "Chelidonium majus, Echinacea, Gentiana lutea, Arsenicum
album, Carbo vegetabilis, Lycopodium clavatum, Nux vomica, Phosphorus, Pulsatil
la" LIQUID ORAL 20100517 UNAPPROVED HOMEOPATHIC
Apotheca Company ACTIVATED CHARCOAL; ARSENIC TRIOXIDE; CHELIDONIUM MAJUS;
ECHINACEA; GENTIANA LUTEA ROOT; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PULSATIL
LA VULGARIS; STRYCHNOS NUX-VOMICA SEED 12; 12; 3; 3; 3; 12; 12; 12; 12 [hp_X]/m
[hp_X]/mL
57520-0419_439dfa56-a1e1-48d8-88d1-80491d221d7c 57520-0419 HUMAN OTC DRUG
Musco MXT "Eleuthero, Epiphegus virginiana, Lacticum acidum, Tecoma pentap
hylla, Hydrocotyle asiatica, Hydrocyanicum acidum," LIQUID ORAL 20100614
UNAPPROVED HOMEOPATHIC Apotheca Company "CENTELLA ASIATICA; ELEU
THERO; EPIFAGUS VIRGINIANA; HYDROGEN CYANIDE; LACTIC ACID, DL-; TABEBUIA HETEROP
HYLLA BARK" 100; 15; 15; 100; 15; 15 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL;
[hp_C]/mL; [hp_C]/mL; [hp_C]/mL
57520-0421_fe56a0e4-7fea-4f91-83be-dd1a6d6c3b5e 57520-0421 HUMAN OTC DRUG
Rehydrate "Avena sativa, Equisetum hyemale, Hypericum perforatum,
Ulmus fulva, Glycyrrha glabra, Pueraria lobata," LIQUID ORAL 20100614
UNAPPROVED HOMEOPATHIC Apotheca Company ADENOSINE TRIPHOSPHATE;
AVENA SATIVA FLOWERING TOP; EQUISETUM HYEMALE; GERMANIUM SESQUIOXIDE; GLYCYRRHIZ
A GLABRA; HYDROGEN; HYPERICUM PERFORATUM; OXYGEN; PUERARIA MONTANA VAR. LOBATA R
OOT; ULMUS RUBRA BARK; WATER 30; 3; 4; 30; 12; 30; 6; 30; 12; 6; 30 [hp_C]/m
L; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL;
[hp_X]/mL; [hp_X]/mL; [hp_C]/mL
57520-0422_ab27b164-3e7c-4757-973d-a05f5d9b1e51 57520-0422 HUMAN OTC DRUG
AsthmaClear "Ambrosia artemisiaefolia, Antimonium tartaricum, Carbo
vegetabilis, Ipecacuanha, Kali carbonicum, Lobelia inflata, Oxygenium," CAPSULE
ACTIVATED CHARCOAL; AMBROSIA ARTEMISIIFOLIA; ANTIMONY POTASSIUM TARTRATE; IPECAC
; LOBELIA INFLATA; OXYGEN; PHOSPHORUS; POTASSIUM CARBONATE; PULSATILLA VULGARIS;
SAMBUCUS NIGRA SUBSP. CANADENSIS FLOWERING TOP; SILICON DIOXIDE; THUJA OCCIDENT
ALIS LEAFY TWIG 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/1; [hp_C]
/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]
/1; [hp_C]/1; [hp_C]/1
57520-0423_f15a4fae-b01a-4016-8fe2-f99517e61ff5 57520-0423 HUMAN OTC DRUG
Migraine Relief "Belladonna, Bryonia, Cyclamen europaeum, Gelsemium semp
ervirens, Sanguianaria canadensis, Spigelia anthelmia" CAPSULE ORAL 20101006
UNAPPROVED HOMEOPATHIC Apotheca Company ATROPA BELLADONNA; BRYON
IA ALBA ROOT; CYCLAMEN PURPURASCENS TUBER; GELSEMIUM SEMPERVIRENS ROOT; SANGUINA
RIA CANADENSIS ROOT; SPIGELIA ANTHELMIA 10; 10; 8; 6; 8; 8 [hp_X]/1; [hp_X]
/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
57520-0424_a434d123-4144-40a0-8914-0cdbf3eeea31 57520-0424 HUMAN OTC DRUG
Restless Legs Relief "Gnaphalium polycephalum, Viscum album, Aconitum
napellus, Ledum palustre, Magnesia phosphorica, Rhus toxicodendron," TABLET
"ACONITUM NAPELLUS; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE
; PSEUDOGNAPHALIUM OBTUSIFOLIUM; TOXICODENDRON PUBESCENS LEAF; VISCUM ALBUM FRUI
TING TOP" 6; 6; 6; 4; 6; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1;
[hp_X]/1; [hp_X]/1
57520-0425_3b5b4bdf-9afa-4663-a9b4-492df3bf0ded 57520-0425 HUMAN OTC DRUG
Type 3 Sinus Regular "Silicea, Hydrastis canadensis, Kali bichromicum
, Calcarea carbonica," TABLET ORAL 20100603 UNAPPROVED HOMEO
PATHIC Apotheca Company "GOLDENSEAL; OYSTER SHELL CALCIUM CARBON
ATE, CRUDE; POTASSIUM DICHROMATE; SILICON DIOXIDE" 6; 12; 6; 2 [hp_X]/m
g; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg
57520-0426_0dafd9c3-c46a-4cbf-a713-3e2ea4d5875c 57520-0426 HUMAN OTC DRUG
Type 3 Sinus Max "Calcarea carbonica, Hydrastis canadensis, Kali
bichromicum, Silicea," TABLET ORAL 20100714 UNAPPROVED HOMEO
PATHIC Apotheca Company "GOLDENSEAL; OYSTER SHELL CALCIUM CARBON
ATE, CRUDE; POTASSIUM DICHROMATE; SILICON DIOXIDE" 200; 200; 200; 200
[hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg
57520-0427_8a97bdae-acc6-447c-88d6-d43b3a952e8d 57520-0427 HUMAN OTC DRUG
Type 4 Noise Regular "Causticum, Chininum sulphuricum, Cinchona offic
inalis, Pulsatilla, Thiosinaminum," TABLET ORAL 20100715
UNAPPROVED HOMEOPATHIC Apotheca Company ALLYLTHIOUREA; CAUSTICUM
; CINCHONA OFFICINALIS BARK; PULSATILLA VULGARIS; QUININE SULFATE 6; 3; 6;
6; 3 [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg
57520-0428_3f06b0ee-59c2-4a90-a680-f863b12b40cb 57520-0428 HUMAN OTC DRUG
Type 4 Noise Max "Causticum, Chininum sulphuricum, Cinchona offic
inalis Pulsatilla, Thiosinaminum," TABLET ORAL 20100714
UNAPPROVED HOMEOPATHIC Apotheca Company ALLYLTHIOUREA; CAUSTICUM
; CINCHONA OFFICINALIS BARK; PULSATILLA VULGARIS; QUININE SULFATE 200; 200
; 200; 200; 200 [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg
57520-0429_4c24e149-8f3e-498d-8139-5c2bc8c26ed2 57520-0429 HUMAN OTC DRUG
Type 7 Stress Anxiety Regular "Kali phosphoricum, Phosphoricum acidum,
Sepia, Sulphus Calcarea carbonica, Silicea," TABLET ORAL 20100714
UNAPPROVED HOMEOPATHIC Apotheca Company "OYSTER SHELL CALCIUM CA
RBONATE, CRUDE; PHOSPHORIC ACID; POTASSIUM PHOSPHATE, DIBASIC; SEPIA OFFICINALIS
JUICE; SILICON DIOXIDE; SULFUR" 12; 6; 3; 6; 12; 6 [hp_X]/mg; [hp_X
]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg
57520-0430_1c6dbf78-6b9e-48b8-826d-5a2ede6d652a 57520-0430 HUMAN OTC DRUG
Type 7 Stress Anxiety Max "Calcarea carbonica, Kali phosphoricum,
Phosphoricum acidum, Sepia, Silicea, Sulphur," TABLET ORAL 20100715
UNAPPROVED HOMEOPATHIC Apotheca Company "OYSTER SHELL CALCIUM CA
RBONATE, CRUDE; PHOSPHORIC ACID; POTASSIUM PHOSPHATE, DIBASIC; SEPIA OFFICINALIS
JUICE; SULFUR" 200; 200; 200; 200; 200 [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/
mg; [hp_C]/mg
57520-0431_a5500e1f-9d32-46c3-8f61-adfb785108ff 57520-0431 HUMAN OTC DRUG
Type 11 Dizziness Regular "Belladonna, Phosphorus, Pulsatilla, Cal
carea carbonica, Silicea," TABLET ORAL 20100715 UNAPPROV
ED HOMEOPATHIC Apotheca Company "ATROPA BELLADONNA; OYSTER SHELL
CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PULSATILLA VULGARIS; SILICON DIOXIDE"
6; 12; 6; 6; 12 [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg
57520-0432_58cf025e-cbd8-47e9-b5d6-3fa3e608d040 57520-0432 HUMAN OTC DRUG
Type 11 Dizziness Max "Belladonna, Calcarea carbonica, Phosphorus, Pul
satilla, Silicea," TABLET ORAL 20100715 UNAPPROVED HOMEO
PATHIC Apotheca Company "ATROPA BELLADONNA; OYSTER SHELL CALCIUM
CARBONATE, CRUDE; PHOSPHORUS; PULSATILLA VULGARIS; SILICON DIOXIDE" 200; 200
; 200; 200; 200 [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg
57520-0434_65dbd6d0-d7d5-4ffb-ba2b-7a5b01673a1b 57520-0434 HUMAN OTC DRUG
Hypothalmupar "Aralia quinquefolia, Ginkgo biloba, Hydrocotyle asiatic
a" LIQUID ORAL 20100521 UNAPPROVED HOMEOPATHIC
Apotheca Company AMERICAN GINSENG; CENTELLA ASIATICA; GINKGO; PHOSPHORUS;
PORK BRAIN; SILICON DIOXIDE; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PITUITARY GLAN
D 3; 3; 3; 12; 6; 12; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/
mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0435_206a8520-8253-41d5-9400-88ae5f0f13c1 57520-0435 HUMAN OTC DRUG
Dentastat "Allium sativum, Berberis vulgaris, Fucus vesiculosus, P
hytolacca decandra, Argentum metallicum, Aurum metallicum, Calcarea fluorica, Ca
lcarea phosphorica, Iodium, Mercurius solubilis, Niccolum metalli" LIQUID
BERBERIS VULGARIS ROOT BARK; CALCIUM FLUORIDE; FUCUS VESICULOSUS; GARLIC; GOLD;
IODINE; MERCURIUS SOLUBILIS; NICKEL; PHYTOLACCA AMERICANA ROOT; PLATINUM; SILICO
N DIOXIDE; SILVER; TRIBASIC CALCIUM PHOSPHATE; ZINC 3; 12; 3; 3; 12; 12; 12;
mL; [hp_X]/mL; [hp_X]/mL
57520-0436_6b9689b3-182e-4007-a173-4fbb27fa8747 57520-0436 HUMAN OTC DRUG
Diabenex HP "Aceticum acidum, Colchicum autumnale, Lacticum acidum,
Lycopodium clavatum, Phosphoricum acidum, Phosphorus, Syzgium jambolanum, Uraniu
m nitricum" LIQUID ORAL 20100521 UNAPPROVED HOMEOPATHIC
Apotheca Company "ACETIC ACID; COLCHICUM AUTUMNALE BULB; LACTIC ACID, DL-
; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PHOSPHORUS; SYZYGIUM CUMINI SEED;
URANYL NITRATE HEXAHYDRATE" 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X
57520-0438_8097549e-729a-43dd-ad26-0edfbf299a55 57520-0438 HUMAN OTC DRUG
Adrenapar "Aralia quinquefolia, Avena sativa, Glandula suprarenali
s" LIQUID ORAL 20100525 UNAPPROVED HOMEOPATHIC
Apotheca Company AMERICAN GINSENG; ARSENIC TRIIODIDE; AVENA SATIVA FLOWER
ING TOP; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PHOSPHORUS; STRYCHNOS IGNAT
II SEED; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA ADRENAL GLAND; ZINC 3; 12; 3
57520-0439_32ef0907-e0bf-4161-8a91-f5784055b191 57520-0439 HUMAN OTC DRUG
Bactestat "Baptisia tinctoria, Echinacea, Phytolacca decandra, Aco
nitum napellus, Arsenicum album, Belladonna, Ferrum phosphoricum, Lachesis mutus
, Phosphorus" LIQUID ORAL 20100521 UNAPPROVED HOMEOPATHIC
Apotheca Company ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA;
BAPTISIA TINCTORIA ROOT; ECHINACEA; FERRUM PHOSPHORICUM; LACHESIS MUTA VENOM; PH
OSPHORUS; PHYTOLACCA AMERICANA ROOT 12; 12; 12; 3; 3; 12; 12; 12; 3 [hp_X]/m
[hp_X]/mL
57520-0440_f03a7c97-9d7d-4c7a-89b3-3be11f67cf4b 57520-0440 HUMAN OTC DRUG
Arnica Arnica montana LIQUID ORAL 20100525 UNAPPROV
ED HOMEOPATHIC Apotheca Company ARNICA MONTANA 3 [hp_X]/m
L
57520-0441_3f57d9aa-65ad-4946-9225-8581f75c1367 57520-0441 HUMAN OTC DRUG
Pancreaplex "Chelidonium majus, Glycyrrhiza glabra, Hydrastis canade
nsis, Nux muschata" LIQUID ORAL 20100521 UNAPPROVED HOMEO
PATHIC Apotheca Company BEEF LIVER; BOS TAURUS PANCREAS; CHELIDO
NIUM MAJUS; GINGER; GLYCYRRHIZA GLABRA; GOLDENSEAL; KIDNEY BEAN; NUTMEG; PHOSPHO
RIC ACID; PHOSPHORUS; RHEUM OFFICINALE ROOT; SUS SCROFA ADRENAL GLAND; SUS SCROF
A PITUITARY GLAND; SYZYGIUM CUMINI SEED; TARAXACUM OFFICINALE; THYROID 6; 6; 3;
57520-0442_382bf7fb-7d82-486d-8274-9b0006175ee1 57520-0442 HUMAN OTC DRUG
Arrythmiaforce "Convallaria majalis, Juglans nigra, Leonurus cardiaca,
Adonis vernalis, Magnesia sulphurica," LIQUID ORAL 20100521
UNAPPROVED HOMEOPATHIC Apotheca Company ADONIS VERNALIS; BLACK W
ALNUT LEAVES; CONVALLARIA MAJALIS; DIGITALIS; IBERIS AMARA SEED; LEONURUS CARDIA
CA; LYCOPUS VIRGINICUS; MAGNESIUM SULFATE HEPTAHYDRATE; PHOSPHORUS; POTASSIUM CH
LORATE 4; 3; 3; 12; 6; 3; 12; 4; 12; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/
57520-0443_6c760728-d25e-4c5d-be1b-9f546f2ce729 57520-0443 HUMAN OTC DRUG
Dopamine Dopamine LIQUID ORAL 20100520
UNAPPROVED HOMEOPATHIC Apotheca Company DOPAMINE 6
[hp_X]/mL
57520-0444_e231affd-35ad-4a5c-8a90-877289c30c4e 57520-0444 HUMAN OTC DRUG
Tryptophan "Tryptophan," LIQUID ORAL 20100603
UNAPPROVED HOMEOPATHIC Apotheca Company TRYPTOPHAN 30
[hp_C]/mL
57520-0445_34fa089d-8d0b-4891-9cd1-99c25eabb54d 57520-0445 HUMAN OTC DRUG
Kidney Tonic I "Echinacea angustifolia, Petroselinum sativum, Solidago
vigraurea, Uva-ursi, Pareira brava, Gluthathione, Kidney, Cantharis, Lycopodium
clavatum," LIQUID ORAL 20101008 UNAPPROVED HOMEOPATHIC
Apotheca Company ARCTOSTAPHYLOS UVA-URSI LEAF; CHONDRODENDRON TOMENTOSUM
ROOT; ECHINACEA ANGUSTIFOLIA; GLUTATHIONE; LYCOPODIUM CLAVATUM SPORE; LYTTA VESI
CATORIA; PETROSELINUM CRISPUM; PORK KIDNEY; SOLIDAGO VIRGAUREA FLOWERING TOP
57520-0447_066e4813-26ce-4a31-a515-96f240edc059 57520-0447 HUMAN OTC DRUG
Menopause "Angelica archangelica, Aralia quinquefolia, Cimicifuga
racemosa, Hydrastis canadensis, Pulsatilla, Sabina, Sepia, Sulphuricum acidum, L
achesis mutus," LIQUID ORAL 20100520 UNAPPROVED HOMEOPATHIC
Apotheca Company AMERICAN GINSENG; ANGELICA ARCHANGELICA ROOT; BLACK COHO
SH; GOLDENSEAL; LACHESIS MUTA VENOM; PULSATILLA VULGARIS; SAVIN; SEPIA OFFICINAL
IS JUICE; SULFURIC ACID 3; 3; 3; 3; 15; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [h
57520-0450_fcd3a5f2-afbd-4f7f-9c92-9a77a0de1e4d 57520-0450 HUMAN OTC DRUG
Restless Legs Relief "Aconitum napellus, Gnaphalium polycephalum, Led
um palustre, Magnesia phosphorica, Rhus Toxicodendron, Viscum album" TABLET
"ACONITUM NAPELLUS; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE
; PSEUDOGNAPHALIUM OBTUSIFOLIUM; TOXICODENDRON PUBESCENS LEAF; VISCUM ALBUM FRUI
TING TOP" 6; 6; 6; 4; 6; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1;
[hp_X]/1; [hp_X]/1
57520-0451_bdc5679c-3006-4256-a527-f933447f0ea2 57520-0451 HUMAN OTC DRUG
Bio Beech Beech LIQUID ORAL 20101123 UNAPPROV
ED HOMEOPATHIC Apotheca Company FAGUS SYLVATICA FLOWER 200
[hp_C]/mL
57520-0452_18d8428f-3a71-4494-af48-61a4a78ea383 57520-0452 HUMAN OTC DRUG
Prostoforce "Aralia quinquefolia, Damiana, Hydrocotyle asiatica, Jun
iperus virginiana, Pareira brava, Sabal serrulata, Thuja occidentalis, Clematis
erecta, Conium maculatum, Pulsatilla," LIQUID ORAL 20101115
UNAPPROVED HOMEOPATHIC Apotheca Company AMERICAN GINSENG; CENTEL
LA ASIATICA; CHONDRODENDRON TOMENTOSUM ROOT; CLEMATIS RECTA FLOWERING TOP; CONIU
M MACULATUM FLOWERING TOP; JUNIPERUS VIRGINIANA TWIG; PULSATILLA VULGARIS; SAW P
ALMETTO; THUJA OCCIDENTALIS LEAFY TWIG; TURNERA DIFFUSA LEAFY TWIG 3; 3; 3;
57520-0453_988a56bb-dde6-4129-a34a-02f008af2b6c 57520-0453 HUMAN OTC DRUG
hcgPLUS "Coenzyme Q-10, Cyanocobalamin, Folic acid, L-carnitine, Taurine
, Biotin, Proline," LIQUID ORAL 20100802 UNAPPROVED HOMEO
PATHIC Apotheca Company "BIOTIN; CYANOCOBALAMIN; FOLIC ACID; LEV
OCARNITINE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; OYSTER SHELL CALCIUM CARBON
ATE, CRUDE; PROLINE; SOMATROPIN; TAURINE; UBIDECARENONE" 8; 6; 6; 6; 30;
30; 8; 34; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL
57520-0455_3eb9b1e5-5e8a-4cc5-8889-18ddb891cd2e 57520-0455 HUMAN OTC DRUG
Hot Flash Rescue "Capsicum annuum, Pulsatilla, Sanguinaria canade
nsis," LOTION TOPICAL 20110621 UNAPPROVED HOMEOPATHIC
Apotheca Company CAPSICUM; PULSATILLA VULGARIS; SANGUINARIA CANADENSIS RO
OT 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g
57520-0457_0f1b590c-1669-4665-b1b3-2196ca43e0cd 57520-0457 HUMAN OTC DRUG
Food Additives "Berberis vulgaris, Chelidonium majus, Trifolium pratens
e, Glycyrrhiza glabra, Lappa major, Phytolacca decandra, Rhamnus frangula,"
Company ARCTIUM LAPPA ROOT; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BERBERI
S VULGARIS ROOT BARK; CHELIDONIUM MAJUS; FRANGULA ALNUS BARK; FRANGULA PURSHIANA
BARK; GLYCYRRHIZA GLABRA; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PHYTOLACC
A AMERICANA ROOT; RED CLOVER; SODIUM SULFATE; STILLINGIA; ZANTHOXYLUM AMERICANUM
BARK 4; 12; 12; 3; 3; 4; 4; 4; 12; 12; 4; 3; 12; 4; 4 [hp_X]/mL; [hp_X
57520-0459_098d07a6-c2c5-4c14-97ab-1fef4f04d58a 57520-0459 HUMAN OTC DRUG
Albuminuriaforce "Equisetum hyemale, Solidago virgaurea, Apis mel
lifica, Mercurius corrosivus, Nux moschata, Phosphorus, Terebinthina," LIQUID
APIS MELLIFERA; EQUISETUM HYEMALE; MERCURIC CHLORIDE; NUTMEG; PHOSPHORUS; SOLIDA
GO VIRGAUREA FLOWERING TOP; TURPENTINE 12; 3; 12; 12; 12; 3; 12 [hp_X]/m
57520-0460_ef4def8d-12f6-4f54-b70e-ad5630793e8a 57520-0460 HUMAN OTC DRUG
Melatonin "Melatonin," LIQUID ORAL 20100603
UNAPPROVED HOMEOPATHIC Apotheca Company MELATONIN 30
[hp_C]/mL
57520-0461_1fbdb6ba-5cce-4745-a663-a4b4e41fec75 57520-0461 HUMAN OTC DRUG
Bio Gentian "Gentian," LIQUID ORAL 20100603
UNAPPROVED HOMEOPATHIC Apotheca Company GENTIANA LUTEA ROOT
200 [hp_C]/mL
57520-0462_90956e1b-14fe-47a0-99ee-e10599cc0358 57520-0462 HUMAN OTC DRUG
Bio Red Chestnut Red chestnut LIQUID ORAL 20100603
UNAPPROVED HOMEOPATHIC Apotheca Company AESCULUS CARNEA FLOWER
200 [hp_C]/mL
57520-0463_fce97825-532b-4e4d-b1b7-dc01bcd3a8b9 57520-0463 HUMAN OTC DRUG
Fungustat I "Ecninacea, Tabebuia impetiginosa, Abies nigra, Lycopodi
um clavatum, Nux vomica, Phosphorus, Pulsatilla," LIQUID ORAL 20100602
UNAPPROVED HOMEOPATHIC Apotheca Company CANDIDA ALBICANS; ECHINA
CEA; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PICEA MARIANA RESIN; PULSATILLA VULG
ARIS; SEPIA OFFICINALIS JUICE; SKATOLE; STRYCHNOS NUX-VOMICA SEED; TABEBUIA IMPE
TIGINOSA BARK 30; 3; 12; 12; 12; 12; 12; 15; 12; 3 [hp_X]/mL; [hp_X]/mL; [h
]/mL
57520-0464_773ea16a-07da-46d9-b4e1-3ade3b41c9dc 57520-0464 HUMAN OTC DRUG
Bac HP "Apis mellifica, Arsenicum album, Belladonna, Chamomilla, Ecinac
ea, Lachesis mutus, Mercurius solubilis," LIQUID ORAL 20100602
TRIOXIDE; ATROPA BELLADONNA; ECHINACEA; LACHESIS MUTA VENOM; MATRICARIA RECUTITA
; MERCURIUS SOLUBILIS; PULSATILLA VULGARIS; RANCID BEEF; SILICON DIOXIDE; TOXICO
DENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/m
57520-0466_f8bda96c-faf9-4d5d-9887-91946739e432 57520-0466 HUMAN OTC DRUG
Lym D "Chelidonium majus, Echinacea angustifolia, Hydrastis canadensis
, Nasturtium aquaticum, Taraxacum officinale, Trifolium pratense, Urtica dioica,
Apotheca Company ARSENIC TRIOXIDE; BORRELIA BURGDORFERI; CHELIDONIUM MAJU
S; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM
SPORE; PHOSPHORUS; PROTORTONIA CACTI; RED CLOVER; RORIPPA NASTURTIUM-AQUATICUM;
SUS SCROFA THYMUS; TARAXACUM OFFICINALE; THYROID; TOXICODENDRON PUBESCENS LEAF;
URTICA DIOICA 12; 200; 3; 3; 3; 200; 12; 12; 12; 3; 3; 8; 3; 8; 12; 3 [hp_X]/m
_X]/mL
57520-0467_0a756b33-b0ae-49a6-8d9c-8bd22e367b48 57520-0467 HUMAN OTC DRUG
Metalogin "Allium sativum, Berberis vulgaris, Glycyrrhiza glabra,
Lappa major, Phytolacca Decandra, Rahmnus frangula, Stillingia sylvatica,"
Company ACTIVATED CHARCOAL; ALUMINUM; ARCTIUM LAPPA ROOT; ARSENIC; BARIU
M; BERBERIS VULGARIS ROOT BARK; BERYLLIUM; BORON; BROMINE; CADMIUM; CERIUM; CESI
UM; CHROMIUM; COBALT; COPPER; DYSPROSIUM; ERBIUM; EUROPIUM; FLUORINE; FRANGULA A
LNUS BARK; GADOLINIUM; GALLIUM; GARLIC; GERMANIUM; GLYCYRRHIZA GLABRA; HOLMIUM;
HYDROGEN; INDIUM; IODINE; IRON; LANTHANUM; LEAD; LITHIUM; LYCOPODIUM CLAVATUM SP
ORE; MANGANESE; MERCURY; METHIONINE; MOLYBDENUM; NEODYMIUM; NICKEL; NIOBIUM; NIT
ROGEN; OXYGEN; PHYTOLACCA AMERICANA ROOT; PRASEODYMIUM; RED CLOVER; RUBIDIUM; SA
MARIUM; SCANDIUM; SELENIUM; SELENIUM DIOXIDE; SILICON; SILVER; STILLINGIA SYLVAT
ICA ROOT; STRONTIUM; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA THYROID; TANTALUM; TE
RBIUM; THULIUM; TIN; TITANIUM; YTTERBIUM; ZINC 30; 30; 3; 30; 30; 3; 30; 30; 30
; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 3; 30; 30; 3; 30; 3; 30; 30; 30; 30; 3
0; 30; 30; 30; 12; 30; 30; 6; 30; 30; 30; 30; 30; 30; 3; 30; 3; 30; 30; 30; 30;
8; 30; 30; 3; 30; 12; 6; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [h
57520-0468_d9cefcef-4048-49a9-9d0c-0379c136ff3f 57520-0468 HUMAN OTC DRUG
Thyro Tonic "Chelidonium majus, Spongia tosta, Lac defloratum, Fucus
vesiculosus, Hepar, Pituitary, Thyroidinum, Iodium," LIQUID ORAL 20100527
UNAPPROVED HOMEOPATHIC Apotheca Company "CHELIDONIUM MAJUS; FERR
OUS IODIDE; FUCUS VESICULOSUS; IODINE; MOLYBDENUM; OYSTER SHELL CALCIUM CARBONAT
E, CRUDE; PORK LIVER; POTASSIUM IODIDE; PULSATILLA VULGARIS; SKIM MILK; SPONGIA
OFFICINALIS SKELETON, ROASTED; SUS SCROFA PITUITARY GLAND; THYROID" 3; 12; 3
0; 12; 12; 12; 8; 12; 12; 8; 3; 100; 100 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL;
57520-0470_4e6f48a4-f792-4bae-9c9c-adea946215c9 57520-0470 HUMAN OTC DRUG
Sciatic Rescue "Phytolacca decandra, Gnaphalium polycephalum, Colocynth
is, Gelsemium sempervirens," GEL TOPICAL 20110620 UNAPPROV
ED HOMEOPATHIC Apotheca Company CITRULLUS COLOCYNTHIS FRUIT PULP
; GELSEMIUM SEMPERVIRENS ROOT; PHYTOLACCA AMERICANA ROOT; PSEUDOGNAPHALIUM OBTUS
IFOLIUM 6; 6; 1; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g
57520-0472_dd0167ce-c3fc-4012-b598-367f439472ec 57520-0472 HUMAN OTC DRUG
Sciatic Rescue "Phytolacca decandra, Gnaphalium polycephalum, Colocynth
is, Gelsemium sempervirens," GEL TOPICAL 20111121 UNAPPROV
ED HOMEOPATHIC Apotheca Company CITRULLUS COLOCYNTHIS FRUIT PULP
; GELSEMIUM SEMPERVIRENS ROOT; PHYTOLACCA AMERICANA ROOT; PSEUDOGNAPHALIUM OBTUS
IFOLIUM 6; 6; 1; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g
57520-0473_31b1d7cb-7c65-4615-87a8-94794e515c4c 57520-0473 HUMAN OTC DRUG
HCGDelivery com "Cyanocobalamin(B-12), Glandula suprarenalis suis(adrena
l), Hepar suis(liver), Thyroidinum, Magnesia phosphorica, Natrum phosphoricum, H
uman chorionic gonadotropin(HCG)," LIQUID ORAL 20101210
UNAPPROVED HOMEOPATHIC Apotheca Company "CYANOCOBALAMIN; HUMAN C
HORIONIC GONADOTROPIN; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PORK LIVER; SODI
UM PHOSPHATE, DIBASIC ANHYDROUS; SUS SCROFA ADRENAL GLAND; SUS SCROFA THYROID"
60; 34; 60; 60; 60; 60; 60 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_
57520-0474_2078d157-5fc6-480a-a424-81f60a9fdb51 57520-0474 HUMAN OTC DRUG
Platinum for Men "Cyanocobalamin, Glandula suprarenalis suis, Kal
i carbonicum, L-carnitine, L-glutamine, L-ornithine, L-tryptophan, L-tyrosine,"
Company "CYANOCOBALAMIN; GLUTAMINE; HUMAN CHORIONIC GONADOTROPIN; LEVOCA
RNITINE; ORNITHINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM CARBONATE;
SUS SCROFA ADRENAL GLAND; SUS SCROFA OVARY; SUS SCROFA THYROID; TRYPTOPHAN; TYRO
SINE" 6; 6; 60; 6; 6; 12; 6; 6; 6; 8; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL;
p_X]/mL; [hp_X]/mL
57520-0477_be9d7935-5338-46c5-b137-4027fab553d7 57520-0477 HUMAN OTC DRUG
Estrogen "Folliculinum, Oophorinum," LIQUID ORAL 20100716
Y 6; 6 [hp_X]/mL; [hp_X]/mL
57520-0479_37d28834-1b1b-4550-8512-3b2f92c9f5b8 57520-0479 HUMAN OTC DRUG
Hepastat "Beta vulgaris, Carduus marianus, Taraxacum officinale,
Cholesterinum, Fel tauri, Chelidonium majus, Lycopodium clavatum," LIQUID
BETA VULGARIS; BOS TAURUS BILE; CHELIDONIUM MAJUS; CHOLESTEROL; LYCOPODIUM CLAVA
TUM SPORE; PHOSPHORUS; SILYBUM MARIANUM SEED; SODIUM SULFATE; STRYCHNOS NUX-VOMI
CA SEED; TARAXACUM OFFICINALE 3; 6; 12; 6; 12; 12; 3; 12; 12; 3 [hp_X]/m
57520-0480_d76778e0-9fc4-4382-9569-3f0fc4e06624 57520-0480 HUMAN OTC DRUG
Envirostat "Berberis vulgaris, Chelidonium majus, Lappa major, Phyt
olacca Decandra, Calcarea fluorica, Carbo animalis, Nux vomica," LIQUID
ARCTIUM LAPPA ROOT; BERBERIS VULGARIS ROOT BARK; CALCIUM FLUORIDE; CARBO ANIMALI
S; CHELIDONIUM MAJUS; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; SEPIA OFFICINALIS J
UICE; STRYCHNOS NUX-VOMICA SEED; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 3; 3; 12
57520-0481_8bf94eaf-01fc-45d7-b331-3c4395c3fa49 57520-0481 HUMAN OTC DRUG
57520-0482_f18cd6c8-c862-451f-8b34-53ba8479f1ae 57520-0482 HUMAN OTC DRUG
[hp_X]/g
57520-0484_19cc1248-4668-41db-be1f-2fc083050a74 57520-0484 HUMAN OTC DRUG
"BELLIS PERENNIS; COMFREY LEAF; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASI
57520-0489_7626465a-158f-408e-abf4-867824e42aac 57520-0489 HUMAN OTC DRUG
Lung Large Intestine "Aloe socotrina, Alumina, Apis mellifica"
Company ACTIVATED CHARCOAL; ALOE; ALUMINUM OXIDE; APIS MELLIFERA; ARSENI
C TRIOXIDE; BARIUM CARBONATE; BRYONIA ALBA ROOT; LEAD; MATRICARIA RECUTITA; PHOS
PHORUS; POTASSIUM DICHROMATE; RANCID BEEF; SULFUR 30; 30; 30; 30; 30; 30;
mL; [hp_C]/mL
57520-0490_1229fc47-0176-4c06-a4db-22163b1fe4be 57520-0490 HUMAN OTC DRUG
Progesterone "Progesterone," LIQUID ORAL 20101207
[hp_X]/mL
57520-0491_40fa9780-5402-4075-a4fd-8d17511d0c11 57520-0491 HUMAN OTC DRUG
Strength F "Isoleucine, Arginine, Carnitine, Alpha keto glutaricum
acid, Leucine, Ornithine, Valine, Estrogen, Progesterone, Testosterone,"
Company .ALPHA.-KETOGLUTARIC ACID; ARGININE; CARNITINE; ESTRADIOL; ESTRI
OL; ESTRONE; ISOLEUCINE; LEUCINE; ORNITHINE; PROGESTERONE; TESTOSTERONE; VALINE
6; 6; 6; 200; 200; 200; 6; 6; 6; 200; 200; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL;
[hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [h
p_X]/mL; [hp_X]/mL
57520-0493_c51c5d5d-792b-4534-83d6-4b0e76d38760 57520-0493 HUMAN OTC DRUG
3 Heart "Phytolacca decandra, Spongia tosta, Aurum metallicum, Coffea cr
uda Crocus sativus," LIQUID ORAL 20100623 UNAPPROVED HOMEO
PATHIC Apotheca Company "ARABICA COFFEE BEAN; GOLD; PHYTOLACCA A
MERICANA ROOT; SAFFRON; SPONGIA OFFICINALIS SKELETON, ROASTED" 1; 1; 3; 1; 3
[hp_M]/mL; [hp_M]/mL; [hp_X]/mL; [hp_M]/mL; [hp_X]/mL
57520-0494_b0489ac0-01f8-40f2-ab76-9e22af921bb2 57520-0494 HUMAN OTC DRUG
12 Male Reproductive "Chimaphila umbellata, Pituitary, Sabal serrulat
a, Uva-ursi, Gelsemium sempervirens, Sarsaparilla, Kali phosphoricum, Phosphoric
um acidum, Zincum metallicum" LIQUID ORAL 20100618 UNAPPROV
ED HOMEOPATHIC Apotheca Company "ARCTOSTAPHYLOS UVA-URSI LEAF; C
HIMAPHILA UMBELLATA; GELSEMIUM SEMPERVIRENS ROOT; PHOSPHORIC ACID; POTASSIUM PHO
SPHATE, DIBASIC; SARSAPARILLA; SAW PALMETTO; SUS SCROFA PITUITARY GLAND; ZINC"
6; 3; 30; 1; 1; 30; 6; 3; 1 [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_M]/mL; [hp_
M]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_M]/mL
57520-0495_a2ca7ad9-b791-433c-b56f-021fc11cd260 57520-0495 HUMAN OTC DRUG
Virustat "Echinacea, Hydrastis canadensis, Lomatium, Acontium Nap
ellus" LIQUID ORAL 20100622 UNAPPROVED HOMEOPATHIC
ECHINACEA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; GO
LDENSEAL; LACHESIS MUTA VENOM; LOMATIUM; RANCID BEEF; TOXICODENDRON PUBESCENS LE
AF 12; 12; 12; 3; 12; 12; 3; 12; 3; 30; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL;
p_X]/mL
57520-0497_6f501b18-c7cb-4410-90ad-40e5cd4713d1 57520-0497 HUMAN OTC DRUG
Allerstat II "Baptisia tinctoria, Echinacea, Allium cepa" LIQUID
AMBROSIA ARTEMISIIFOLIA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; ECHINACEA; E
UPHRASIA STRICTA; ONION; PHOSPHORUS; PULSATILLA VULGARIS; SODIUM SULFATE; SOLIDA
GO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; SULFUR 12; 12; 3; 3; 12
mL
57520-0498_c1730749-f8c4-4490-bb7d-117911de4db9 57520-0498 HUMAN OTC DRUG
Parastat "Artemisia vulgaris, Cina, Filix mas, Sabadilla, Spigeli
a anthelmia," LIQUID ORAL 20100622 UNAPPROVED HOMEOPATHIC
Apotheca Company "ARTEMISIA CINA FLOWER; ARTEMISIA VULGARIS ROOT; BARIUM
CARBONATE; DRYOPTERIS FILIX-MAS ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SCH
OENOCAULON OFFICINALE SEED; SPIGELIA; SULFUR; TURPENTINE" 3; 3; 12; 3; 12;
; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0499_5980342d-9cc9-4789-a930-88df0b6a14ad 57520-0499 HUMAN OTC DRUG
Headache Tonic "Cardsuus marianus, Pyrethrum parthenium, Secale cornutu
m, Aconitum napellus, Belladonna, Bryonia," LIQUID ORAL 20100621
UNAPPROVED HOMEOPATHIC Apotheca Company ACONITUM NAPELLUS; ATROP
A BELLADONNA; BRYONIA ALBA ROOT; CLAVICEPS PURPUREA SCLEROTIUM; GELSEMIUM SEMPER
VIRENS ROOT; MELILOTUS OFFICINALIS POLLEN; NITROGLYCERIN; SEPIA OFFICINALIS JUIC
E; SILYBUM MARIANUM SEED; SPIGELIA; STRYCHNOS NUX-VOMICA SEED; TANACETUM PARTHEN
IUM 12; 12; 12; 6; 12; 12; 12; 12; 1; 12; 12; 1 [hp_X]/mL; [hp_X]/mL; [h
57520-0500_8efa347a-b2da-4990-b2d0-59ec2f9373e1 57520-0500 HUMAN OTC DRUG
Pneumoplex "Plantago major, Arsenicum album, Lung, Symphytum offici
nale, Silicea, Phellandrium aquaticum, Phosphorus, Sulphur" LIQUID ORAL
ARSENIC TRIOXIDE; COMFREY ROOT; OENANTHE AQUATICA FRUIT; PHOSPHORUS; PLANTAGO MA
JOR; SILICON DIOXIDE; SULFUR; SUS SCROFA LUNG 6; 6; 12; 12; 3; 8; 12; 6
_X]/mL
57520-0501_be442d33-a554-45ff-beb3-2cbe81b281b9 57520-0501 HUMAN OTC DRUG
Bactestat "Baptisia tinctoria, Echinacea, Phytolacca decandra"
Company ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BAPTISIA
TINCTORIA ROOT; ECHINACEA; FERRUM PHOSPHORICUM; LACHESIS MUTA VENOM; PHOSPHORUS
; PHYTOLACCA AMERICANA ROOT 12; 12; 12; 3; 3; 12; 12; 12; 3 [hp_X]/mL; [hp_X
L
57520-0502_5011a034-d9c5-48ab-b8e1-786273963a15 57520-0502 HUMAN OTC DRUG
HCG Cleanse "Abrotanum, Anacardium orientale, Arsenicum album, Baryt
a muriatica, Helleborus niger, Ignatia amara, Lycopodium clavatum," SPRAY
"ARSENIC TRIOXIDE; ARTEMISIA ABROTANUM FLOWERING TOP; BARIUM CHLORIDE DIHYDRATE;
CLAVICEPS PURPUREA SCLEROTIUM; HELLEBORUS NIGER ROOT; HUMAN CHORIONIC GONADOTRO
PIN; LYCOPODIUM CLAVATUM SPORE; NIACINAMIDE; OYSTER SHELL CALCIUM CARBONATE, CRU
DE; SEMECARPUS ANACARDIUM JUICE; SILICON DIOXIDE; STRYCHNOS IGNATII SEED; SUS SC
ROFA THYMUS; SUS SCROFA THYROID; TRIBASIC CALCIUM PHOSPHATE" 30; 30; 30; 30;
30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL;
[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [h
57520-0503_acaf0551-6fdf-4a5e-b215-947adc55f375 57520-0503 HUMAN OTC DRUG
Dr. L Advanced HCG Formula "Chromium GTF, Hypothalamus, HCG, Garcin
a cambogia," LIQUID ORAL 20100714 UNAPPROVED HOMEOPATHIC
Apotheca Company BOS TAURUS HYPOTHALAMUS; CHORIOGONADOTROPIN ALFA; CHROMI
UM PICOLINATE; HYDROXYCITRIC ACID 13; 34; 13; 34 [hp_C]/mL; [hp_C]/mL; [h
p_C]/mL; [hp_C]/mL
57520-0504_158c3581-a313-48a6-9482-0ac6c9b608d0 57520-0504 HUMAN OTC DRUG
MP "Achyrocline satureioides, Arctostaphylos uva-ursi, Cassia occid
entalis, Mirailis jalapa, Petiveria alliacea, Physalis angulata, Schinus molle,"
Company ACHYROCLINE SATUREIOIDES; ARCTOSTAPHYLOS UVA-URSI LEAF; MIRABILI
S JALAPA TOP; PETIVERIA ALLIACEA ROOT; PHYSALIS ANGULATA; SCHINUS MOLLE BARK; SE
NNA OCCIDENTALIS 32; 32; 32; 32; 32; 32; 32 [hp_X]/mL; [hp_X]/mL; [h
57520-0505_09e2c99b-6201-44ae-90d7-65c93417b896 57520-0505 HUMAN OTC DRUG
Parasite Detox "Filix mas, Granatum, Juglans regia, Rhamnus purshiana,
Absinthium, Aesculus hippocastanum, Arsenicum album, Baptisia tinctoria,"
Company ARSENIC TRIOXIDE; ARTEMISIA CINA FLOWER; BAPTISIA TINCTORIA ROOT
; COPPER; DRYOPTERIS FILIX-MAS ROOT; FRANGULA PURSHIANA BARK; HORSE CHESTNUT; IP
ECAC; JUGLANS REGIA LEAF; KRAMERIA LAPPACEA ROOT; LYCOPODIUM CLAVATUM SPORE; MER
CURY; PULSATILLA VULGARIS; PUNICA GRANATUM ROOT BARK; SANTONIN; SCHOENOCAULON OF
FICINALE SEED; SILICON DIOXIDE; SPIGELIA ANTHELMIA; STRYCHNOS NUX-VOMICA SEED; T
EUCRIUM MARUM; TOXICODENDRON PUBESCENS LEAF; WORMWOOD 15; 15; 15; 15; 3; 3; 15
; 15; 3; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X
57520-0509_21e8289c-a33e-47a5-afe9-76e06b071556 57520-0509 HUMAN OTC DRUG
Vermex "Artemisia vulgaris, Cina, Filix mas, Spigelia anthelmia, Teucri
um marum, Calcarea carbonica, Graphites," LIQUID ORAL 20100622
UNAPPROVED HOMEOPATHIC Apotheca Company "ARTEMISIA CINA FLOWER;
ARTEMISIA VULGARIS ROOT; ASCARIS LUMBRICOIDES; DRYOPTERIS FILIX-MAS ROOT; GRAPHI
TE; MERCURIC CHLORIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SCHOENOCAULON OFFI
CINALE SEED; SILICON DIOXIDE; SPIGELIA ANTHELMIA; TAENIA SOLIUM; TANACETUM VULGA
RE TOP; TEUCRIUM MARUM" 3; 3; 200; 3; 12; 12; 12; 12; 12; 3; 200; 12; 3 [hp_X]/m
57520-0510_e8e39779-dbcf-4cb9-a56e-21acb6b81f3c 57520-0510 HUMAN OTC DRUG
Arterioforce II "Baptisia tinctoria, Echinacea, Hydrastis canadensis"
Company ARNICA MONTANA; BAPTISIA TINCTORIA ROOT; BARIUM CARBONATE; CLAVI
CEPS PURPUREA SCLEROTIUM; CONIUM MACULATUM FLOWERING TOP; ECHINACEA; FENUGREEK S
EED; GOLDENSEAL; MYRRH; PHYTOLACCA AMERICANA ROOT; POTASSIUM IODIDE; PROPOLIS WA
X; RORIPPA NASTURTIUM-AQUATICUM; SELENICEREUS GRANDIFLORUS STEM 6; 3; 12; 12; 12
; 3; 4; 3; 4; 3; 5; 6; 4; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_
57520-0511_81db60ba-a6f4-4a9a-86a2-7df8dbc8b2ba 57520-0511 HUMAN OTC DRUG
Enuresis "Equisetum hyemale, Solidago virgaurea, Uva-ursi, Argent
um metallicum, Causticum" LIQUID ORAL 20100615 UNAPPROV
ED HOMEOPATHIC Apotheca Company ARCTOSTAPHYLOS UVA-URSI LEAF; CA
USTICUM; EQUISETUM HYEMALE; NITRIC ACID; SEPIA OFFICINALIS JUICE; SILVER; SOLIDA
GO VIRGAUREA FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; WOOD CREOSOTE
57520-0512_44463740-2eb6-4695-8a79-9778fbca357d 57520-0512 HUMAN OTC DRUG
Pre/Post Surgery "Hypericum perforatum, Symphytum officinale, Arn
ica montana" LIQUID ORAL 20100618 UNAPPROVED HOMEOPATHIC
Apotheca Company ARNICA MONTANA; COMFREY ROOT; HYPERICUM PERFORATUM
200; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0513_77438252-09db-4e44-978d-560dac98409f 57520-0513 HUMAN OTC DRUG
Sinuforce "Echinacea, Hydrastis canadensis, Nux moschata, Trigonal
la foenum graecum, Arsenicum album, Kali bichromicum, Mercurius sulphuratus rube
r, Pulsatilla, Sepia, Mercurius solubilis" LIQUID ORAL 20100618
UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; ECHINA
CEA; FENUGREEK SEED; GOLDENSEAL; MERCURIC SULFIDE; MERCURIUS SOLUBILIS; NUTMEG;
POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE 12; 3; 3
57520-0514_1f275616-395a-4a30-9a92-3bb4583c1b69 57520-0514 HUMAN OTC DRUG
Skin Relief Plus "Aloe socotrina, Phosphorus, Silicea, Sulphur,"
Company ALOE; PHOSPHORUS; SILICON DIOXIDE; SULFUR 200; 30; 30; 30
[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL
57520-0515_a5b1bb8b-ae6e-41ad-b263-71b6a530a418 57520-0515 HUMAN OTC DRUG
Menadione "Menadione," LIQUID ORAL 20100616
UNAPPROVED HOMEOPATHIC Apotheca Company MENADIONE 30
[hp_C]/mL
57520-0516_f42417ba-96dc-44b7-95b1-5d1b4f1be522 57520-0516 HUMAN OTC DRUG
Bio Chestnut Bud Chestnut bud LIQUID ORAL 20100714
UNAPPROVED HOMEOPATHIC Apotheca Company AESCULUS HIPPOCASTANUM F
LOWER 200 [hp_C]/mL
57520-0517_faee4ef4-eb03-423f-91f0-3b7d5debbdb3 57520-0517 HUMAN OTC DRUG
Bio Holly "Holly," LIQUID ORAL 20100616
UNAPPROVED HOMEOPATHIC Apotheca Company ILEX AQUIFOLIUM FLOWERIN
G TOP 200 [hp_C]/mL
57520-0518_32bee6c5-0e7c-4b91-bd84-282c64a149a3 57520-0518 HUMAN OTC DRUG
Lym D HP "Arsenicum album, Chelidonium majus, Coccus cacti, Echinacea ang
ustifolia, Hydrastis canadensis, Lycopodium clavatum," LIQUID ORAL 20100715
UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; BORREL
IA BURGDORFERI; CHELIDONIUM MAJUS; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; LYCOPODIU
M CLAVATUM SPORE; PHOSPHORUS; PROTORTONIA CACTI; RORIPPA NASTURTIUM-AQUATICUM; T
ARAXACUM OFFICINALE; THYMUS; THYROID; TOXICODENDRON PUBESCENS LEAF; TRIFOLIUM PR
ATENSE POLLEN; URTICA DIOICA 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30;
; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [
hp_C]/mL; [hp_C]/mL
57520-0519_eefc36b3-d640-41fb-9109-ada6ddfc5d8e 57520-0519 HUMAN OTC DRUG
Grain and Seed Antigen "Barley, Oats, Wheat, Rice, Rye, Millet, Soybean
, Corn, Milo, Bamboo, Cotton seed, Flax seed," LIQUID ORAL 20100721
UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; BAMBUS
A VULGARIS TOP; BARLEY; CORN; COTTON SEED; FLAX SEED; HELIANTHUS ANNUUS; LYCOPOD
IUM CLAVATUM SPORE; MILLET; OAT; POPPY SEED; RICE; RYE; SAFFLOWER; SESAME; SODIU
M CHLORIDE; SORGHUM BICOLOR SSP. BICOLOR POLLEN; SOYBEAN; SUGARCANE; SULFUR; WHE
AT 12; 30; 30; 30; 30; 30; 30; 12; 30; 30; 30; 30; 30; 30; 30; 12; 30; 30;
X]/mL
57520-0520_d554a2f1-2f22-48a3-93cc-dadf60d91eb8 57520-0520 HUMAN OTC DRUG
Nux Vomica "Nux vomica," PELLET ORAL 20110616
UNAPPROVED HOMEOPATHIC Apotheca Company STRYCHNOS NUX-VOMICA SEE
D 12 [hp_X]/g
57520-0521_fc668c11-b2c5-40a0-90cc-8cc5a9f7cdac 57520-0521 HUMAN OTC DRUG
Ear Inflammation Plus "Belladonna, Conium maculatum, Dulcamara,"
Company ATROPA BELLADONNA; CALCIUM SULFIDE; CONIUM MACULATUM FLOWERING T
OP; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS; POTASSIUM DICHROMATE; PULSATILLA V
ULGARIS; SILICON DIOXIDE; SOLANUM DULCAMARA TOP 30; 30; 30; 30; 30; 30; 30; 30;
30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]
/mL; [hp_X]/mL; [hp_X]/mL
57520-0522_a1565ba4-68aa-47e0-bcba-b8f9f8d934e7 57520-0522 HUMAN OTC DRUG
Allersode II "Allium cepa, Ambrosia artemisiaefolia, Euphrasia offici
nalis" LIQUID ORAL 20100625 UNAPPROVED HOMEOPATHIC
Apotheca Company ACER NEGUNDO POLLEN; AGROSTIS GIGANTEA; AMBROSIA ACANTHI
CARPA POLLEN; AMBROSIA ARTEMISIIFOLIA; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA
PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; ARSENIC TRIOXIDE; BETULA OCCIDENTA
LIS POLLEN; CARYA OVATA POLLEN; DACTYLIS GLOMERATA; EUPHRASIA STRICTA; FAGUS GRA
NDIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; HISTAMINE DIHYDROCHLORIDE; JUGLANS N
IGRA POLLEN; ONION; PHLEUM PRATENSE; PHOSPHORUS; PLATANUS OCCIDENTALIS POLLEN; P
OA PRATENSIS; POPULUS DELTOIDES POLLEN; PORK LIVER; PULSATILLA VULGARIS; QUERCUS
RUBRA POLLEN; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN; SALIX NIGRA POLLEN
; SCHOENOCAULON OFFICINALE SEED; SULFUR; SUS SCROFA ADRENAL GLAND; ULMUS AMERICA
NA POLLEN 26; 26; 26; 3; 26; 26; 26; 12; 26; 26; 26; 3; 26; 26; 30; 26; 3;
26; 12; 26; 26; 26; 24; 12; 26; 26; 26; 26; 6; 12; 24; 26 [hp_X]/mL; [hp_X
/mL; [hp_X]/mL
57520-0523_a94cdc15-3ba4-4816-b57f-be354878b5c7 57520-0523 HUMAN OTC DRUG
GABA Gaba LIQUID ORAL 20100714 UNAPPROVED HOMEO
PATHIC Apotheca Company .GAMMA.-AMINOBUTYRIC ACID 6
[hp_X]/mL
57520-0524_dad96e2f-1be4-43fa-a53e-52c5b1273c7a 57520-0524 HUMAN OTC DRUG
Joint Pain "Arnica montana, Bryonia alba, Causticum, Rhus toxicoden
dron, Ferrum phosphoricum" LIQUID ORAL 20100618 UNAPPROV
ED HOMEOPATHIC Apotheca Company ARNICA MONTANA; BRYONIA ALBA ROO
T; CAUSTICUM; FERRUM PHOSPHORICUM; TOXICODENDRON PUBESCENS LEAF 4; 4; 4; 8; 6
57520-0525_7677d3a0-664e-4dcf-8d8e-c03b443f2e5b 57520-0525 HUMAN OTC DRUG
Diathesis IV "Fel tauri, Ginkgo biloba, Kidney, Germanium sesquioxide
, Argentum metallicum, Cuprum metallicum, Cysteinum, Aurum metallicum, Manganum
gluconicum," LIQUID ORAL 20110215 UNAPPROVED HOMEOPATHIC
Apotheca Company .ALPHA.-KETOGLUTARIC ACID; BOS TAURUS BILE; COPPER; CYST
EINE; FUMARIC ACID; GERMANIUM SESQUIOXIDE; GINKGO; GOLD; MANGANESE GLUCONATE; ME
RCURIUS SOLUBILIS; PHOSPHORIC ACID; PORK KIDNEY; SILVER; SODIUM OXALATE; STRYCHN
OS NUX-VOMICA SEED 12; 30; 9; 9; 12; 8; 6; 12; 10; 12; 12; 30; 9; 12; 12
/mL
57520-0526_0d561306-63fd-47c7-9324-f2b5732da8c4 57520-0526 HUMAN OTC DRUG
Anti Hive "Ammonium carbonicum, Apis mellifica, Argentum metallicu
m, Arsenicum album, Dulcamara, Mezereum, Ehus toxicodendron, Urtica urens,"
Company AMMONIUM CARBONATE; APIS MELLIFERA; ARSENIC TRIOXIDE; DAPHNE MEZ
EREUM BARK; SILVER; SOLANUM DULCAMARA TOP; TOXICODENDRON PUBESCENS LEAF; URTICA
URENS 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/
57520-0527_faaff7dd-1fa2-468b-8491-fa4269c77824 57520-0527 HUMAN OTC DRUG
Endo Pure Testos (for Women) "DNA, RNA, Sabal serrulata, Cortisol (hy
drocortisone), Glandula suprarenalis, Hypothalamus, Pituitary, Testosterone, Che
lidonium majus, Thuja occidentalis," LIQUID ORAL 20101210
UNAPPROVED HOMEOPATHIC Apotheca Company CHELIDONIUM MAJUS; HERRI
NG SPERM DNA; HYDROCORTISONE; SACCHAROMYCES CEREVISIAE RNA; SAW PALMETTO; SUS SC
ROFA ADRENAL GLAND; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PITUITARY GLAND; TESTOST
ERONE; THUJA OCCIDENTALIS LEAFY TWIG 12; 6; 6; 6; 6; 6; 6; 6; 6; 12 [hp_C]/m
L; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL;
[hp_C]/mL; [hp_C]/mL
57520-0528_02350e1d-ab21-4936-ada5-70235f810391 57520-0528 HUMAN OTC DRUG
Infectistat "Baptisia tinctoria, Echinacea, Hydrastis canadensis, Lo
belia inflata, Lomatium, Phytolacca decandra, Symphytum officinale, Lung, Aconit
um napellus, Arsenicum album, Belladonna, Bryonia, Causticum," LIQUID ORAL
ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT;
BRYONIA ALBA ROOT; CAUSTICUM; COMFREY ROOT; ECHINACEA; EUPATORIUM PERFOLIATUM F
LOWERING TOP; FERRUM PHOSPHORICUM; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; HYPE
RICUM PERFORATUM; LACHESIS MUTA VENOM; LOBELIA INFLATA; LOMATIUM DISSECTUM ROOT;
PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; POTASSIUM CARBONATE; PULSATILLA VULGARIS
; RANCID BEEF; SILICON DIOXIDE; SODIUM SULFATE; SULFUR; SUS SCROFA LUNG; TOXICOD
ENDRON PUBESCENS LEAF 12; 12; 12; 3; 12; 12; 3; 3; 12; 12; 12; 3; 12; 12; 3; 3
; 12; 3; 12; 12; 30; 12; 12; 12; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/
]/mL
57520-0529_c2f7f84e-5c5b-4869-978b-c3f5884d9779 57520-0529 HUMAN OTC DRUG
Virotox WN "Echinacea angustifolia, Hydrastis canadensis, Lomatium,
Myrrha, Nasturtium aquaticum, Tabebuia impetiginosa, Glandula suprarenalis, Thy
mus" LIQUID ORAL 20101207 UNAPPROVED HOMEOPATHIC
Apotheca Company ATROPA BELLADONNA; ECHINACEA ANGUSTIFOLIA; GELSEMIUM SEM
PERVIRENS ROOT; GOLDENSEAL; LOMATIUM DISSECTUM ROOT; LYCOPODIUM CLAVATUM SPORE;
MYRRH; RANCID BEEF; RORIPPA NASTURTIUM-AQUATICUM; STRYCHNOS NUX-VOMICA SEED; SUS
SCROFA ADRENAL GLAND; SUS SCROFA THYMUS; TABEBUIA IMPETIGINOSA BARK; WEST NILE
VIRUS 12; 3; 12; 3; 3; 12; 3; 200; 3; 12; 8; 8; 3; 200 [hp_X]/mL; [hp_X
57520-0530_82be2c63-8e3c-49c6-83e0-960fa8232a85 57520-0530 HUMAN OTC DRUG
Anxiety II HP "Aconitum napellus, Arsenicum album, Belladonna, Calcarea carbon
ica, Carcinosin, Causticum, Gelsemium sempervirens, Lachesis mutus," SPRAY
"ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; CAUSTICUM; GELSEMIUM SE
MPERVIRENS ROOT; HUMAN BREAST TUMOR CELL; LACHESIS MUTA VENOM; MERCURY; NITRIC A
CID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; TOXICODENDRON PUBESCENS
LEAF" 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [h
p_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C
]/mL; [hp_C]/mL; [hp_C]/mL
57520-0531_0e68f85c-172c-4e64-873a-cce1d38f0f9e 57520-0531 HUMAN OTC DRUG
Thymus "Thymus," SPRAY ORAL 20101207 UNAPPROV
ED HOMEOPATHIC Apotheca Company SUS SCROFA THYMUS 8
[hp_X]/mL
57520-0532_75e36dd0-fdd7-435c-b579-fd78ef25522c 57520-0532 HUMAN OTC DRUG
Vertiforce "Leonurus cardiaca, Agaricus muscarius, Arsenicum album,
Cocculus indicus, Conium maculatum, Petroleum, Phosphorus, Pulsatilla, Tabacum,
Theridion," LIQUID ORAL 20101207 UNAPPROVED HOMEOPATHIC
Apotheca Company AMANITA MUSCARIA VAR. MUSCARIA; ANAMIRTA COCCULUS SEED;
ARSENIC TRIOXIDE; CONIUM MACULATUM FLOWERING TOP; KEROSENE; LEONURUS CARDIACA; P
HOSPHORUS; PULSATILLA VULGARIS; THERIDION CURASSAVICUM; TOBACCO LEAF 12; 12;
57520-0535_55b09121-0798-4700-b235-eb213dcebce4 57520-0535 HUMAN OTC DRUG
Liver Tonic I "Carduus marianus, Chelidonium majus, Taraxacum officina
le, Chionanthus virginica, Quassia amara, Hepar bovinum," LIQUID ORAL
BEEF LIVER; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS
BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; CULVER'S ROOT; PHOSPHORUS; QUASSIA AMAR
A WOOD; SILYBUM MARIANUM SEED; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; TARAXA
CUM OFFICINALE; TEUCRIUM MARUM 200; 12; 1; 3; 12; 12; 12; 3; 1; 12; 12; 1; 12
57520-0539_34fd3857-e3c4-4228-a2a7-a3dcdb229a40 57520-0539 HUMAN OTC DRUG
Neuralgia HP "Agaricus muscarius, Arnica montana, Hypericum perforatu
m, phosphorus, Plumbum metallicum, Mercurius solubilis, Allium cepa, Lycopodium
clavatum," LIQUID ORAL 20100716 UNAPPROVED HOMEOPATHIC
Apotheca Company AMANITA MUSCARIA VAR. MUSCARIA; ARNICA MONTANA; HYPERICU
M PERFORATUM; LEAD; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; ONION; PHOSP
HORUS 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/
57520-0542_c47df08e-9f63-4917-b1c1-2d015dc7ac0f 57520-0542 HUMAN OTC DRUG
Quercetin "Quercetin," LIQUID ORAL 20101208
[hp_C]/mL
57520-0544_04e17358-a418-4fdc-bf49-4519c221a896 57520-0544 HUMAN OTC DRUG
Sciatica HP "Aconitum napellus, Aesculus hippocastanum, Colchicum au
tumnale, Hypericum perforatum, Magnesia phosphorica, Plumbum metallicum, Rhus to
xicodendron, Arnica Montana," LIQUID ORAL 20101210 UNAPPROV
ED HOMEOPATHIC Apotheca Company "ACONITUM NAPELLUS; ARNICA MONTA
NA; COLCHICUM AUTUMNALE BULB; HORSE CHESTNUT; HYPERICUM PERFORATUM; LEAD; MAGNES
IUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF" 30; 30;
30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [
57520-0545_95e55a0d-8b14-4fe0-8396-012b5e9710b3 57520-0545 HUMAN OTC DRUG
Hot Flash Rescue "Capsicum annuum, Pulsatilla, Sanguinaria canade
nsis," SPRAY TOPICAL 20110607 UNAPPROVED HOMEOPATHIC
Apotheca Company PAPRIKA; PULSATILLA VULGARIS; SANGUINARIA CANADENSIS ROO
T 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0546_65ae67dd-a629-40b1-a1be-0b5f5000f5f7 57520-0546 HUMAN OTC DRUG
Ovaplex "Angelica archangelica, Caulophyllum thalictroides, Dioscorea vi
llosa, Oophorinum, Pituitary, Thyroidinum, Uterus, Zincum gluconicum, Apis melli
fica," LIQUID ORAL 20101214 UNAPPROVED HOMEOPATHIC
Apotheca Company "ANGELICA ARCHANGELICA ROOT; APIS MELLIFERA; ATROPA BELL
ADONNA; BLACK COHOSH; CAULOPHYLLUM THALICTROIDES ROOT; DIOSCOREA VILLOSA ROOT; M
AGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SEPIA OFFICINALIS JUICE; SUS SCROFA OVAR
Y; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYROID; SUS SCROFA UTERUS; ZINC GLUCO
NATE" 3; 12; 12; 12; 3; 3; 12; 12; 6; 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [h
]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0547_f4edc561-c578-4b23-a17d-5151f1878f0f 57520-0547 HUMAN OTC DRUG
Injury Topical "Arnica montana, Calendula officinalis, Hypericum perfor
atum, Symphytum officinale, Bellis perennis, Carbo vegetabilis," GEL
ACHILLEA MILLEFOLIUM; ACTIVATED CHARCOAL; ARNICA MONTANA; BELLIS PERENNIS; CALEN
DULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STE
M BARK; HYPERICUM PERFORATUM; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBES
CENS LEAF; VERATRUM ALBUM ROOT 12; 12; 3; 12; 1; 3; 12; 12; 12; 12; 12 [hp_X]/g
; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g
; [hp_X]/g; [hp_X]/g
57520-0548_c28591f3-0488-4e74-814a-5f2486f68e27 57520-0548 HUMAN OTC DRUG
NADH Plus "Nadidum, Adenosinum cyclophosphoricum, Calcium D - pant
othenate,Cholinum, Riboflavinum, Ubiquinone, Dimethyl glycine," SPRAY ORAL
"ADENOSINE CYCLIC 3',5'-PHOSPHATE; CALCIUM PANTOTHENATE; CHOLINE HYDROXIDE; GLYC
INE; NADIDE; RIBOFLAVIN; UBIDECARENONE" 6; 6; 6; 7; 4; 6; 6 [hp_X]/mL; [hp_X
]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0549_370c33af-ffc9-40cb-93ed-7a299f21cccb 57520-0549 HUMAN OTC DRUG
Tri Estrogen "Folliculinum, Oophorinum," LIQUID ORAL 20101011
Y 6; 6 [hp_X]/mL; [hp_X]/mL
57520-0550_41186316-30fc-414e-ac91-32b84c1fa946 57520-0550 HUMAN OTC DRUG
Thyroid HP "Baryta carbonica, Calcarea carbonica, Fucus vesiculosus, Iodium
, Natrum muriaticum, Pulsatilla, Spongia tosta, Thyroidinum," LIQUID ORAL
"BARIUM CARBONATE; FUCUS VESICULOSUS; IODINE; OYSTER SHELL CALCIUM CARBONATE, CR
UDE; PULSATILLA VULGARIS; SODIUM CHLORIDE; SPONGIA OFFICINALIS SKELETON, ROASTED
; SUS SCROFA THYROID" 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [h
57520-0551_e64930cc-8aba-4d00-9501-859fac705a2f 57520-0551 HUMAN OTC DRUG
Prostatone "Echinacea, Hydrastis canadensis, Phytolacca decandra, S
abal serrulata, Sarsaparilla, Solidago virgaurea, Zincum sulphuricum," LIQUID
CLEMATIS RECTA FLOWERING TOP; ECHINACEA; GOLDENSEAL; PHOSPHORIC ACID; PHYTOLACCA
AMERICANA ROOT; PULSATILLA VULGARIS; SARSAPARILLA ROOT; SAW PALMETTO; SOLIDAGO
VIRGAUREA FLOWERING TOP; SUS SCROFA PROSTATE; SUS SCROFA TESTICLE; ZINC SULFATE
HEPTAHYDRATE 12; 3; 3; 12; 3; 12; 3; 3; 3; 8; 8; 3 [hp_X]/mL; [hp_X]/mL; [h
57520-0552_8cfbee0c-af38-4321-8210-6dfc99496b15 57520-0552 HUMAN OTC DRUG
Gastrotone "Capsicum annuum, Foeniculum vulgare, Symphytum officina
le, Argentum nitricum, Arsenicum album, Magnesia phosphorica, Pulsatilla,"
Company "ARSENIC TRIOXIDE; CAPSICUM; COMFREY ROOT; FENNEL SEED; MAGNESIU
M PHOSPHATE, DIBASIC TRIHYDRATE; PULSATILLA VULGARIS; SILVER NITRATE" 12; 3; 3
; [hp_X]/mL
57520-0554_b57733ff-2d8f-4f11-9f6f-53b7fa684859 57520-0554 HUMAN OTC DRUG
Chemsode "Triticum aestivum, Glycyrrhiza glabra, Lappa major, Phy
tolacca decandra, Rhamnus purshiana, Trifolium pratense, Nitricum acidum,"
Company "ACETIC ACID; ARCTIUM LAPPA ROOT; ATROPA BELLADONNA; BEEF LIVER;
BENZOIC ACID; BENZYL ALCOHOL; BORIC ACID; BOS TAURUS ADRENAL GLAND; CHLORINE; C
ORTICOTROPIN; CORTISONE ACETATE; ESTRONE; EUGENOL; FRANGULA PURSHIANA BARK; GLYC
YRRHIZA GLABRA; ISOPROPYL PALMITATE; LACTIC ACID, DL-; LEAD; LYCOPODIUM CLAVATUM
SPORE; NITRIC ACID; PETROLATUM; PHENYLBUTAZONE; PHOSPHORIC ACID; PHOSPHORUS; PH
YTOLACCA AMERICANA ROOT; PORK KIDNEY; POTASSIUM SORBATE; RED CLOVER; RESORCINOL;
SALICYLIC ACID; SORBITOL; STEARYL ALCOHOL; STRYCHNOS NUX-VOMICA SEED; SUS SCROF
A LYMPH; WHEAT; XYLITOL" 200; 3; 12; 8; 200; 200; 200; 8; 200; 200; 200;
200; 200; 3; 3; 200; 200; 200; 12; 12; 200; 200; 12; 12; 3; 8; 200; 3; 200; 200;
200; 200; 12; 8; 1; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_
57520-0555_02b09574-b118-48d6-8900-f48641731e3d 57520-0555 HUMAN OTC DRUG
Homeopathic HCG "L-arginine, L-carnitine, L-ornithine, L-tyrosine, HCG(H
uman chorionic conadotropin," LIQUID ORAL 20100809 UNAPPROV
ED HOMEOPATHIC Apotheca Company ARGININE; HUMAN CHORIONIC GONADO
TROPIN; LEVOCARNITINE HYDROCHLORIDE; ORNITHINE; TYROSINE 6; 34; 6; 6; 6
[hp_X]/mL; [hp_C]/mL; [hp_X]/mL; mL/mL; [hp_X]/mL
57520-0556_8d2e5d3f-acba-45de-a296-d6fa7d157906 57520-0556 HUMAN OTC DRUG
Compre Tox "Eriodictyon californicum, Hamamelis virginiana, Nymphae
a odorata, Plantago major, Xanthoxylum fraxineum, Xerophyllum asphodeloides,"
Company ERIODICTYON CALIFORNICUM LEAF; GINGER; HAMAMELIS VIRGINIANA ROOT
BARK/STEM BARK; NYMPHAEA ODORATA ROOT; PLANTAGO MAJOR; XEROPHYLLUM ASPHODELOIDE
S; YUCCA FILAMENTOSA; ZANTHOXYLUM AMERICANUM BARK 3; 3; 3; 3; 3; 3; 3; 3
_X]/mL
57520-0557_a05f627a-bff9-4d66-ad94-ba2e802c9d6a 57520-0557 HUMAN OTC DRUG
ANX HP "Arsenicum album, Calcarea carbonica, Ignatia amara Kali carboni
cum, Lachesis mutus, Natrum muriaticum," LIQUID ORAL 20100721
UNAPPROVED HOMEOPATHIC Apotheca Company "ARSENIC TRIOXIDE; LACHE
SIS MUTA VENOM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; POTASSIUM CAR
BONATE; PULSATILLA VULGARIS; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED" 30; 30;
57520-0559_b34b64a5-e3be-4c56-a41c-5013d34f80db 57520-0559 HUMAN OTC DRUG
Aconite "Aconitum napellus," PELLET ORAL 20100922 20150813
UNAPPROVED HOMEOPATHIC Apotheca Company ACONITUM NAPELLUS
12 [hp_X]/mL
57520-0560_0ecae910-adc6-48aa-a5b4-bb6f9a398d4b 57520-0560 HUMAN OTC DRUG
Arnica Arnica montana PELLET ORAL 20101012 20150813
UNAPPROVED HOMEOPATHIC Apotheca Company ARNICA MONTANA 12
[hp_X]/mL
57520-0561_3d0fa488-ec25-4846-85e0-d33a1a0effc3 57520-0561 HUMAN OTC DRUG
Rhus Tox "Rhus toxicodendron," "PELLETS, COATED, EXTENDED RELEA
SE" ORAL 20100927 20150813 UNAPPROVED HOMEOPATHIC
Apotheca Company TOXICODENDRON PUBESCENS LEAF 12 [hp_X]/mL
57520-0563_aae392d0-2cae-4080-918b-1a00324cc605 57520-0563 HUMAN OTC DRUG
Traumatone "Calendula officinalis, Symphytum officinale, Staphysagr
ia, Rhus Toxicodendron, Ruta Graveolens, Bellis perennis," LIQUID ORAL
ARNICA MONTANA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY RO
OT; DELPHINIUM STAPHISAGRIA SEED; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; PHO
SPHORUS; RUTA GRAVEOLENS FLOWERING TOP; STRONTIUM CARBONATE; TOXICODENDRON PUBES
CENS LEAF 12; 12; 3; 3; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X
57520-0565_99854984-cdf9-429f-8131-058f952a3418 57520-0565 HUMAN OTC DRUG
Sinuchron HP "Arsenicum album, Hepar sulphuris calcareum, Kali bichro
micum, Lycopodium clavatum, Mercurius solubilis, Natrum muriaticum, Phosphorus,
Pulsatilla, Sepia," LIQUID ORAL 20101214 UNAPPROVED HOMEO
PATHIC Apotheca Company ARSENIC TRIOXIDE; CALCIUM SULFIDE; LYCOP
ODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; PHOSPHORUS; POTASSIUM DICHROMATE; PUL
SATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE 30; 30; 30; 30;
57520-0566_60a5a469-47a1-4f0c-8422-63793c651069 57520-0566 HUMAN OTC DRUG
Ginkgo Tonic "Aralia quinquefolia, Ginkgo biloba, Hydrocotyle asiatic
a, Polygonum multiflorum, Aronia melanocarpa, Vaccinium myrtillus, Germanium ses
quioxide, Aurum metallicum Baryta muriatica," LIQUID ORAL 20101220
UNAPPROVED HOMEOPATHIC Apotheca Company "ADENOSINE TRIPHOSPHATE;
AMERICAN GINSENG; ARONIA MELANOCARPA FRUIT; BARIUM CHLORIDE DIHYDRATE; BILBERRY
; CENTELLA ASIATICA; CLAVICEPS PURPUREA SCLEROTIUM; FALLOPIA MULTIFLORA ROOT; GE
RMANIUM SESQUIOXIDE; GINKGO; GOLD; LEAD; POTASSIUM PHOSPHATE, DIBASIC; TOBACCO L
EAF; UBIDECARENONE; VISCUM ALBUM FRUITING TOP" 30; 1; 3; 12; 3; 1; 12; 1; 12; 1
; 12; 12; 12; 12; 30; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_
57520-0568_8d488ac3-b059-49a3-9967-80c2eef073b0 57520-0568 HUMAN OTC DRUG
Bio Chicory Chicory LIQUID ORAL 20101229 UNAPPROV
ED HOMEOPATHIC Apotheca Company CICHORIUM INTYBUS FLOWER
200 [hp_C]/mL
57520-0569_1e27b843-12a4-4a6d-a488-a17b3f693770 57520-0569 HUMAN OTC DRUG
Free Radical "Triticum aestivum, Alfalfa, Fucus vesiculosus, Laminari
a digitata, Nasturtium aquaticum, Oryza sativa, Raphanus sativus, Symphytum offi
cinale, Hordeum vulgare, Asparagus officinalis, Manganum gluconat" LIQUID
.ALPHA.-KETOGLUTARIC ACID; ALFALFA; ALUMINUM; ARNICA MONTANA; ARSENIC; ASPARAGUS
; BARIUM CARBONATE; BERYLLIUM; BORON; BROMINE; CADMIUM; CERIUM; CESIUM CHLORIDE;
COBALT; COMFREY ROOT; COPPER; COPPER; D&C BLACK NO. 2; DYSPROSIUM; ERBIUM; EURO
PIUM; FERRUM PHOSPHORICUM; FUCUS VESICULOSUS; GADOLINIUM; GERMANIUM SESQUIOXIDE;
GLYOXAL; HOLMIUM; HORDEUM VULGARE TOP; HYDROGEN; INDIUM; IODINE; IRON; LAMINARI
A DIGITATA; LANTHANUM; LEAD; LITHIUM; MANGANESE; MANGANESE GLUCONATE; MERCURIUS
SOLUBILIS; MOLYBDENUM; NEODYMIUM; NICKEL; NIOBIUM; NITROGEN; OXYGEN; PRASEODYMIU
M; RADISH; RICE; RORIPPA NASTURTIUM-AQUATICUM; RUBIDIUM; SAMARIUM; SCANDIUM; SEL
ENIUM; SILICON DIOXIDE; SILVER; STRONTIUM CARBONATE; TANTALUM; TERBIUM; THALLIUM
; TIN; TITANIUM; UBIDECARENONE; WHEAT; YTTERBIUM; ZINC 30; 3; 30; 12; 30; 6; 30
; 30; 30; 30; 30; 30; 30; 30; 3; 12; 30; 30; 30; 30; 30; 8; 3; 30; 30; 30; 30; 6
; 30; 30; 30; 30; 3; 30; 30; 30; 30; 6; 30; 30; 30; 30; 30; 30; 30; 30; 3; 3; 3;
30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 12; 1; 30; 30 [hp_X]/mL; [hp_X
57520-0570_b383c68a-73dc-480b-9841-86e4b01bb0c9 57520-0570 HUMAN OTC DRUG
Rescue "Cherry plum, Clematis, Impatiens, Rock Rose, Star of bethlehem,
ER 200; 200; 200; 200; 200 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_
M]/mL
57520-0571_2ac8ed04-3819-43c4-a911-d81b57d5713c 57520-0571 HUMAN OTC DRUG
Fngsode "Ceanothus americanus, Condurango, Echinacea angustifolia, Hydra
stis canadensis, Ligusticum porteri, Lomatium, Nasturtium aquaticum, Tabebuia im
petiginosa, Astragalus membranaceus," LIQUID ORAL 20101221
UNAPPROVED HOMEOPATHIC Apotheca Company ASTRAGALUS PROPINQUUS RO
OT; CANDIDA ALBICANS; CEANOTHUS AMERICANUS LEAF; ECHINACEA ANGUSTIFOLIA; GOLDENS
EAL; LIGUSTICUM PORTERI ROOT; LOMATIUM DISSECTUM ROOT; MARSDENIA CONDURANGO BARK
; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; PORK KIDNEY; PROPOLIS WAX; RORIPPA
NASTURTIUM-AQUATICUM; SEPIA OFFICINALIS JUICE; SODIUM BORATE; SUS SCROFA ADRENA
L GLAND; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; TABEBUIA IMPETIGINOSA BARK
6; 100; 1; 3; 3; 3; 3; 3; 12; 12; 60; 6; 3; 12; 12; 60; 8; 8; 6 [hp_X]/mL; [hp_X
57520-0572_4debf365-33de-46eb-9bac-c417d88e5e5c 57520-0572 HUMAN OTC DRUG
Adrenal Tincture "Chelidonium majus, Echinacea, Glandula supraren
alis bovinum, Spleen, Carduus marianus, Natrum mutiaticum, Phosphoricum acidum,"
Company BOS TAURUS ADRENAL GLAND; BOS TAURUS SPLEEN; CHELIDONIUM MAJUS;
ECHINACEA; PHOSPHORIC ACID; SILYBUM MARIANUM SEED; SODIUM CHLORIDE 24; 24;
hp_X]/mL; [hp_X]/mL
57520-0574_af799f49-f4a0-47c3-bdf6-316c02926ae1 57520-0574 HUMAN OTC DRUG
Bio Chem Detox "Berberis vulgaris, Glycyrrhiza glabra, Lappa major, Phy
tolacca decandra, Rhamnus purshiana, Stillingia sylvatica, Trifolium pratense, T
riticum aestivum, Xanthoxylum fraxineum, Glandula suprarenalis, H" SPRAY
ACONITUM NAPELLUS; ACTIVATED CHARCOAL; AMANITA MUSCARIA VAR. MUSCARIA; ARCTIUM L
APPA ROOT; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BERBERIS VULGARIS ROOT BARK; CHO
NDRODENDRON TOMENTOSUM ROOT; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERI
NG TOP; FRANGULA PURSHIANA BARK; GLYCYRRHIZA GLABRA; LACHESIS MUTA VENOM; LYCOPO
DIUM CLAVATUM SPORE; MERCURIC CHLORIDE; NITRIC ACID; PHOSPHORIC ACID; PHOSPHORUS
; PHYSOSTIGMA VENENOSUM SEED; PHYTOLACCA AMERICANA ROOT; PORK LIVER; STILLINGIA
SYLVATICA ROOT; STRYCHNOS NUX-VOMICA SEED; SULFUR; SUS SCROFA ADRENAL GLAND; SUS
SCROFA LYMPH; SUS SCROFA THYROID; TOBACCO LEAF; TRIFOLIUM PRATENSE FLOWER; WHEA
T; ZANTHOXYLUM AMERICANUM BARK 30; 30; 30; 3; 30; 30; 3; 200; 30; 30; 3; 3; 30;
12; 30; 30; 12; 30; 30; 3; 6; 3; 12; 30; 6; 6; 6; 30; 3; 3; 3 [hp_C]/mL; [hp_C
]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/m
L; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL;
[hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp
_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]
/mL
57520-0575_0d249ea2-c346-464e-8444-a90724829c05 57520-0575 HUMAN OTC DRUG
Sinus Tonic "Echinacea, Baptisia tinctoria, Hydrastis canadensis, Th
iaminum hydrochloricum, Pantothenic acid, Pyridoxinum hydrochloricum, Spongia to
sta, Apis mellifica, Ascorbic acid, Hepar sulphuris calcareum" LIQUID ORAL
"APIS MELLIFERA; ASCORBIC ACID; BAPTISIA TINCTORIA ROOT; CALCIUM SULFIDE; ECHINA
CEA; GOLDENSEAL; LACHESIS MUTA VENOM; MERCURIC IODIDE; MERCURIC SULFIDE; PANTOTH
ENIC ACID; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; PYRIDOXINE HYDROCHLORIDE;
SILICON DIOXIDE; SINUSITISINUM; SPONGIA OFFICINALIS SKELETON, ROASTED; THIAMINE
HYDROCHLORIDE" 12; 12; 3; 12; 2; 3; 12; 12; 12; 6; 12; 12; 6; 12; 200; 6; 4
57520-0576_35870313-82bc-4e30-9fb1-32e79281e216 57520-0576 HUMAN OTC DRUG
Dr L Advanced HCG Formula "Chromium GTF, Hypothalamus, Human chori
onic gonadotropin, Garcinia cambogia," LIQUID ORAL 20110215
UNAPPROVED HOMEOPATHIC Apotheca Company CHROMIUM PICOLINATE; GAR
CINIA CAMBOGIA FRUIT; HUMAN CHORIONIC GONADOTROPIN; SUS SCROFA HYPOTHALAMUS
13; 34; 34; 13 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL
57520-0581_d859bf73-bf70-44d6-90c6-457cd7d6b317 57520-0581 HUMAN OTC DRUG
Sciatica Relief "Capsicum annuum, Colocynthis, Gnaphalium polycephalum,
Magnesia phosphorica," TABLET ORAL 20110317 UNAPPROVED HOMEO
PATHIC Apotheca Company "CAPSICUM; CITRULLUS COLOCYNTHIS FRUIT P
ULP; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PSEUDOGNAPHALIUM OBTUSIFOLIUM"
6; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
57520-0582_4a3b8e30-239b-4bea-9166-ac421a6f4f26 57520-0582 HUMAN OTC DRUG
Fibromyalgia Relief "Aconitum napellus, Arsenicum album, Belladonna,
Coniinum, Gelsemium sempervirens, Hypericum perforatum, Kali bichromicum, Lacti
cum acidum, Phosphoricum acidum, Rhus toxicodendrom, Uricum acidum," TABLET
"ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; CONIINE; GELSEMIUM SEMP
ERVIRENS ROOT; HYPERICUM PERFORATUM; LACTIC ACID, DL-; PHOSPHORIC ACID; POTASSIU
M DICHROMATE; TOXICODENDRON PUBESCENS LEAF; URIC ACID" 30; 30; 30; 30; 30; 30;
30; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]
/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1
57520-0584_82bb6e5a-f784-4e2d-9a46-37838b48fb20 57520-0584 HUMAN OTC DRUG
[hp_X]/g
57520-0585_c0fcd3ca-4f33-4abe-9b90-536d78844e09 57520-0585 HUMAN OTC DRUG
Bio Larch "Larch," LIQUID ORAL 20110113
UNAPPROVED HOMEOPATHIC Apotheca Company LARIX DECIDUA FLOWERING
TOP 200 [hp_C]/mL
57520-0586_ef9d48f3-3a03-454b-89db-3830c3980377 57520-0586 HUMAN OTC DRUG
Cough "Drosera rotundifolia, Coccus cacti, Spongia tosta, Belladonna,
Cuprum aceticum, Kali carbonicum, Mentha piperita, Phosphorus," SYRUP ORAL
"ATROPA BELLADONNA; CUPRIC ACETATE; DROSERA ROTUNDIFOLIA; MENTHA PIPERITA; PHOSP
HORUS; POTASSIUM CARBONATE; PROTORTONIA CACTI; SPONGIA OFFICINALIS SKELETON, ROA
STED" 6; 12; 3; 12; 12; 12; 5; 5 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/
57520-0587_640f4a78-b3fd-4bc2-ae93-22104d92c227 57520-0587 HUMAN OTC DRUG
Endoplex F "Cimicifuga racemosa , Fucus vesiculosus, Glycyrrhiza gl
abra, Xanthoxylum fraxineum, Adrenalinum, Brain, Hypothalamus, Oophorinum, Pinea
l, Pituitarum posterium, Thyroidinum, Pulsatilla, Sepia," LIQUID ORAL
BLACK COHOSH; EPINEPHRINE; FUCUS VESICULOSUS; GLYCYRRHIZA GLABRA; PORK BRAIN; PU
LSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SUS SCROFA HYPOTHALAMUS; SUS SCROFA
OVARY; SUS SCROFA PINEAL GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYROID;
ZANTHOXYLUM AMERICANUM BARK 3; 8; 3; 3; 8; 12; 12; 8; 8; 8; 8; 8; 3 [hp_X]/m
57520-0588_097ebc61-1044-4501-a7e6-dd61ad7ec293 57520-0588 HUMAN OTC DRUG
Strength M "Aralia quinquefolia, Avena sativa, Damiana, Androstened
ione, Arginine, Epimedium, Glutathione, Leucine, Ornithine, Valine, Testosterone
, Sabal serrulata, Sepia," LIQUID ORAL 20110106 UNAPPROV
ED HOMEOPATHIC Apotheca Company AMERICAN GINSENG; ANDROSTENEDION
E; ARGININE; AVENA SATIVA FLOWERING TOP; EPIMEDIUM GRANDIFLORUM FLOWERING TOP; G
LUTATHIONE; LEUCINE; ORNITHINE; SAW PALMETTO; SEPIA OFFICINALIS JUICE; TESTOSTER
ONE; TURNERA DIFFUSA LEAFY TWIG; VALINE 3; 6; 6; 3; 6; 6; 6; 6; 24; 30; 12; 3; 6
57520-0589_28c4e5cb-a852-4b27-9e15-94e7c565f763 57520-0589 HUMAN OTC DRUG
Menopause HP "Belladonna, Lachesis mutus, Nux vomica, Pulsatilla, Sec
ale cornutum, Sepia, Ustilago maidis," LIQUID ORAL 20110113
UNAPPROVED HOMEOPATHIC Apotheca Company ATROPA BELLADONNA; CLAVI
CEPS PURPUREA SCLEROTIUM; LACHESIS MUTA VENOM; PULSATILLA VULGARIS; SEPIA OFFICI
NALIS JUICE; STRYCHNOS NUX-VOMICA SEED; USTILAGO MAYDIS 30; 30; 30; 30; 30; 30;
/mL
57520-0590_a696c848-f2b5-402c-a2c6-1822a97dae81 57520-0590 HUMAN OTC DRUG
Prostatone HP "Clematis erecta, Conium maculatum, Lycopodium clavatum,
Mercurius corrosivus, Pulsatilla, Sabal serrulata, Selenium metallicum, Sepia,
Staphysagria, Thuja occidentalis," LIQUID ORAL 20110120
UNAPPROVED HOMEOPATHIC Apotheca Company CLEMATIS RECTA FLOWERING
TOP; CONIUM MACULATUM FLOWERING TOP; DELPHINIUM STAPHISAGRIA SEED; LYCOPODIUM C
LAVATUM SPORE; MERCURIC CHLORIDE; PULSATILLA VULGARIS; SAW PALMETTO; SELENIUM; S
EPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAFY TWIG 30; 30; 30; 30; 30; 30;
57520-0595_d3471a2c-00f3-40a1-9109-d01c83d1ab6b 57520-0595 HUMAN OTC DRUG
Water X "Betula pendula, cortex, Lappa major, Plantago major, Taraxacum
officinale," CAPSULE ORAL 20110125 UNAPPROVED HOMEOPATHIC
Apotheca Company ARCTIUM LAPPA ROOT; BETULA PENDULA BARK; PLANTAGO MAJOR;
TARAXACUM OFFICINALE 4; 4; 4; 4 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g
57520-0596_90e5f238-3926-4ea7-b8fd-b89a3a81fe80 57520-0596 HUMAN OTC DRUG
Lymphdrainex "Geranium robertianum, Nasturtium aquaticum, Aloe socotr
ina, Juglans regia, Myosotis arvensis, Scrophularia nodosa, Teucrium scorodonia,
Apis mellifica, Equisetum hyemale," LIQUID ORAL 20110131
UNAPPROVED HOMEOPATHIC Apotheca Company ALOE; APIS MELLIFERA; AR
ANEUS DIADEMATUS; BARIUM CARBONATE; CALCIUM SULFIDE; EQUISETUM HYEMALE; FERROUS
IODIDE; FUMARIA OFFICINALIS FLOWERING TOP; GENTIANA LUTEA ROOT; GERANIUM ROBERTI
ANUM; JUGLANS REGIA FLOWERING TOP; MERCURIC CYANIDE; MYOSOTIS ARVENSIS; PHYTOLAC
CA AMERICANA ROOT; PINUS SYLVESTRIS LEAFY TWIG; RORIPPA NASTURTIUM-AQUATICUM; SA
RSAPARILLA ROOT; SCROPHULARIA NODOSA; SODIUM SULFATE; SUS SCROFA PARATHYROID GLA
ND; SUS SCROFA PARATHYROID GLAND; SUS SCROFA THYMUS; SUS SCROFA THYROID; TEUCRIU
M SCORODONIA FLOWERING TOP; TRIBASIC CALCIUM PHOSPHATE; VERONICA OFFICINALIS FLO
WERING TOP 12; 4; 12; 8; 8; 4; 12; 4; 5; 4; 6; 8; 6; 4; 4; 4; 6; 6; 4; 12;
hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_Q]/mL; [hp_
57520-0597_7b959a05-514f-43b3-aa9a-4d145837d3d2 57520-0597 HUMAN OTC DRUG
Lymphdrainex "Geranium robertianum, Nasturtium aquaticum, Aloe socotr
ina, Juglans regia, Myosotis arvensis, Scrophularia nodosa, Teucrium scorodonia,
Apis mellifica, Equisetum hyemale, Fumaria officinalis, Natrum s" LIQUID
ALOE; APIS MELLIFERA; ARANEUS DIADEMATUS; BARIUM CARBONATE; CALCIUM SULFIDE; EQU
ISETUM HYEMALE; FERROUS IODIDE; FUMARIA OFFICINALIS FLOWERING TOP; GENTIANA LUTE
A ROOT; GERANIUM ROBERTIANUM; JUGLANS REGIA FLOWERING TOP; MERCURIC CYANIDE; MYO
SOTIS ARVENSIS; PHYTOLACCA AMERICANA ROOT; PINUS SYLVESTRIS LEAFY TWIG; RORIPPA
NASTURTIUM-AQUATICUM; SARSAPARILLA ROOT; SCROPHULARIA NODOSA; SODIUM SULFATE; SU
S SCROFA PARATHYROID GLAND; SUS SCROFA THYMUS; SUS SCROFA THYROID; TEUCRIUM SCOR
ODONIA FLOWERING TOP; TRIBASIC CALCIUM PHOSPHATE; VERONICA OFFICINALIS FLOWERING
TOP 12; 4; 12; 8; 8; 4; 12; 4; 5; 4; 6; 8; 6; 4; 4; 4; 6; 6; 4; 12; 12; 12;
57520-0598_cce09d45-8564-4996-b701-c5d282a8873b 57520-0598 HUMAN OTC DRUG
VestalCare Spot Free Psoriasis "Calcarea silicata, Lithium carbonicum,
Natrum muriaticum, Phytolacca decandra, Sarsaparilla, Sulphur iodatum, Thyroidin
um," TABLET ORAL 20110225 UNAPPROVED HOMEOPATHIC
Apotheca Company CALCIUM SILICATE; LITHIUM CARBONATE; PHYTOLACCA AMERICAN
A ROOT; SARSAPARILLA ROOT; SODIUM CHLORIDE; SULFUR IODIDE; THYROID 30; 30;
30; 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]
/1; [hp_X]/1
57520-0599_485eb959-3ca6-4ced-83ad-065fd8929611 57520-0599 HUMAN OTC DRUG
Bio Minulus "Mimulus," LIQUID ORAL 20110131
UNAPPROVED HOMEOPATHIC Apotheca Company MIMULUS GUTTATUS FLOWERI
NG TOP 200 [hp_C]/mL
57520-0600_5b8e0e3b-bb6a-4cbb-9d15-58e33049eaca 57520-0600 HUMAN OTC DRUG
RheumatismHP "Bryonia, Colchicum autumnale, Kalmia latifolia, Ledum p
alustre, Lycopodium clavatum, Rhododendron chrysanthum, Rhus toxicodendron,"
Company BRYONIA ALBA ROOT; COLCHICUM AUTUMNALE BULB; KALMIA LATIFOLIA LE
AF; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; RHODODENDRON AUREUM LEAF; TO
XICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X
57520-0603_ff7fae0c-1a0f-4798-9fc9-4e132e771936 57520-0603 HUMAN OTC DRUG
Colic "Beta vulgaris, Carduus marianus, Lappa major, Aluminium metalli
cum, Arsenicum album, Chelidonium majus, Hydrastis canadensis, Lycopodium clavat
um, Natrum sulphuricum, Nux vomica, Phosphorus," LIQUID ORAL 20110128
UNAPPROVED HOMEOPATHIC Apotheca Company ALUMINUM; ARCTIUM LAPPA
ROOT; ARSENIC TRIOXIDE; BETA VULGARIS; CHELIDONIUM MAJUS; GOLDENSEAL; LYCOPODIUM
CLAVATUM SPORE; PHOSPHORUS; SILYBUM MARIANUM SEED; SODIUM SULFATE; STRYCHNOS NU
X-VOMICA SEED 12; 3; 12; 3; 12; 12; 12; 12; 3; 12; 12 [hp_X]/mL; [hp_X]/mL; [h
]/mL; [hp_X]/mL
57520-0604_8daf924a-3671-4cfa-b445-566946429aa9 57520-0604 HUMAN OTC DRUG
HGH "Hepar, Human growth hormone, Pituitarum," LIQUID ORAL
PORK LIVER; SOMATROPIN; SUS SCROFA PITUITARY GLAND 6; 30; 30 [hp_X]/m
57520-0605_d387ab15-19e3-49c7-ba5e-ac2d575973cf 57520-0605 HUMAN OTC DRUG
Pancreaforce "Juniperus virginiana, Lappa major, Rhamnus purshiana, S
yzygium jambolanum, Chelidonium majus, Lycopodium clavatum, Myrtus communis, Nat
rum sulphuricum, Phosphoricum acidum, Phosphorus, Tarentula cuben" LIQUID
ARCTIUM LAPPA ROOT; CHELIDONIUM MAJUS; CITHARACANTHUS SPINICRUS; FRANGULA PURSHI
ANA BARK; JUNIPERUS VIRGINIANA TWIG; LYCOPODIUM CLAVATUM SPORE; MYRTUS COMMUNIS
TOP; PHOSPHORIC ACID; PHOSPHORUS; SODIUM SULFATE; SYZYGIUM CUMINI SEED 3; 12; 1
57520-0606_02325dea-fa0d-45e3-8e44-705f7244cf1f 57520-0606 HUMAN OTC DRUG
Bio Rock Water "Rock Water," LIQUID ORAL 20110204
UNAPPROVED HOMEOPATHIC Apotheca Company HELIANTHEMUM NUMMULARIUM
FLOWER 200 [hp_C]/mL
57520-0607_ae27a933-c19a-407d-8951-947a3999c39f 57520-0607 HUMAN OTC DRUG
Headache "Melilotus officinalis, Spigelia anthelmia, Allium cepa,
Belladonna, Bryonia, Cimicifuga racemosa, Gelsemium sempervirens, Glonoinum, Ma
gnesia phosphorica, Nux vomica," LIQUID ORAL 20110203
UNAPPROVED HOMEOPATHIC Apotheca Company "ATROPA BELLADONNA; BLAC
K COHOSH; BRYONIA ALBA ROOT; CITHARACANTHUS SPINICRUS; GELSEMIUM SEMPERVIRENS RO
OT; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MELILOTUS OFFICINALIS TOP; NITROGLY
CERIN; ONION; SANGUINARIA CANADENSIS ROOT; SILICON DIOXIDE; SPIGELIA ANTHELMIA;
STRYCHNOS NUX-VOMICA SEED" 12; 12; 12; 12; 12; 12; 3; 12; 12; 12; 12; 3; 12
57520-0608_3219ad04-cd61-4407-8c0e-6fb22b7fbe5b 57520-0608 HUMAN OTC DRUG
Homeopathic HCG Formula "Cyanocobalamin, L-carnitine, Ornithine, Human c
horionic gonadotropin," LIQUID ORAL 20110217 UNAPPROVED HOMEO
PATHIC Apotheca Company CYANOCOBALAMIN; HUMAN CHORIONIC GONADOTR
OPIN; LEVOCARNITINE; ORNITHINE 6; 60; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL;
[hp_X]/mL
57520-0609_d3d6a880-92a5-4ee4-84f7-0f177e2b9873 57520-0609 HUMAN OTC DRUG
hCG Formula "Foeniculum vulgare, Fucus vesiculosus, Lecithin, Ammoni
um carbonicum, Caulophyllum thalictroides, Galium aparine, Lac defloratum, Phosp
horus, Phytolacca decandra, Rubus idaeus," SPRAY ORAL 20110208
UNAPPROVED HOMEOPATHIC Apotheca Company "AMMONIUM BROMIDE; AMMON
IUM CARBONATE; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; ARTEMISIA ABROTANUM FLOWER
ING TOP; BARIUM CHLORIDE DIHYDRATE; CALCIUM ARSENATE; CAULOPHYLLUM THALICTROIDES
ROOT; CLAVICEPS PURPUREA SCLEROTIUM; FENNEL SEED; FUCUS VESICULOSUS; GALIUM APA
RINE; HELLEBORUS NIGER ROOT; HUMAN CHORIONIC GONADOTROPIN; LECITHIN, SOYBEAN; LY
COPODIUM CLAVATUM SPORE; MANGANESE; NIACINAMIDE; OYSTER SHELL CALCIUM CARBONATE,
CRUDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; RUBUS IDAEUS LEAF; SEMECARPUS ANA
CARDIUM JUICE; SILICON DIOXIDE; SKIM MILK; STRYCHNOS IGNATII SEED; SUS SCROFA TH
YMUS; SUS SCROFA THYROID; TRIBASIC CALCIUM PHOSPHATE" 8; 6; 8; 30; 30; 30; 8;
6; 30; 2; 3; 6; 30; 60; 3; 30; 8; 30; 30; 6; 6; 6; 30; 30; 6; 30; 30; 30; 30
57520-0610_cf562505-3afe-4c59-8775-2d9c347167fc 57520-0610 HUMAN OTC DRUG
Leg Cramp Relief "Magnesia phosphorica, Cuprum metallicum, Colocy
nthis, Phytolacca decandra, Veratrum album, Causticum, Stannum metallicum, Rhus
toxicodendron," TABLET ORAL 20110223 UNAPPROVED HOMEOPATHIC
Apotheca Company "CAUSTICUM; CITRULLUS COLOCYNTHIS FRUIT PULP; COPPER; MA
GNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PHYTOLACCA AMERICANA ROOT; TIN; TOXICODEN
DRON PUBESCENS LEAF; VERATRUM ALBUM ROOT" 30; 30; 30; 30; 30; 30; 30; 30
[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
57520-0611_627969d3-a40e-4e97-8fbe-5f03cb3fba83 57520-0611 HUMAN OTC DRUG
Insomnia Plus "Arsenicum album, Coffea cruda, Kali carbonicum, Magnesi
a carbonica, Nux vomica, Passiflora incarnata, Sepia, Valeriana officinalis,"
Company ARABICA COFFEE BEAN; ARSENIC TRIOXIDE; MAGNESIUM CARBONATE; PASS
IFLORA INCARNATA TOP; POTASSIUM CARBONATE; SEPIA OFFICINALIS JUICE; STRYCHNOS NU
X-VOMICA SEED; VALERIAN 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [h
57520-0612_ec231637-a608-48b5-9aef-8f8ca4d667e7 57520-0612 HUMAN OTC DRUG
Scrofularoforce "Juniperus virginiana, Rumex crispus, Scrophularia nodos
a, Xanthoxylum fraxineum, Lymph node, Baryta carbonica, Baryta muriatica, Bellad
onna, Calcarea carbonica," LIQUID ORAL 20110214 UNAPPROV
ED HOMEOPATHIC Apotheca Company "ATROPA BELLADONNA; BARIUM CARBO
NATE; BARIUM CHLORIDE DIHYDRATE; CONIUM MACULATUM FLOWERING TOP; HELLEBORUS NIGE
R ROOT; IODINE; JUNIPERUS VIRGINIANA TWIG; LACHESIS MUTA VENOM; OYSTER SHELL CAL
CIUM CARBONATE, CRUDE; POTASSIUM PHOSPHATE, DIBASIC; RUMEX CRISPUS ROOT; SCROPHU
LARIA NODOSA; SILICON DIOXIDE; SODIUM PHOSPHATE, DIBASIC ANHYDROUS; SUS SCROFA L
YMPH; ZANTHOXYLUM AMERICANUM BARK" 12; 12; 12; 12; 12; 12; 3; 12; 12; 12; 3
57520-0613_98777dfe-1808-4c4e-88ce-a625fc645659 57520-0613 HUMAN OTC DRUG
Metabolism "Berberis vulgaris, Glycyrrhiza glabra, Lappa major, Rha
mnus purshiana, Trifolium pratense, Xanthoxylum fraxineum, Ascorbic acid, Cyanoc
obalamin, Riboflavinum, Thiaminum hydrochloricum, German sesquiox" LIQUID
".ALPHA.-KETOGLUTARIC ACID; ADENOSINE TRIPHOSPHATE; ARCTIUM LAPPA ROOT; ASCORBIC
ACID; BERBERIS VULGARIS FRUIT; CALCIUM SULFIDE; CYANOCOBALAMIN; CYSTEINE; FRANG
ULA PURSHIANA BARK; FUMARIC ACID; GERMANIUM SESQUIOXIDE; GLYCYRRHIZA GLABRA; MAG
NESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MANGANESE GLUCONATE; PULSATILLA VULGARIS;
PYRUVIC ACID; RIBOFLAVIN; SODIUM DIETHYL OXALACETATE; THIAMINE HYDROCHLORIDE; TR
IFOLIUM PRATENSE FLOWER; UBIDECARENONE; ZANTHOXYLUM AMERICANUM BARK" 12; 12;
3; 6; 3; 30; 6; 9; 3; 12; 8; 3; 12; 10; 12; 12; 6; 12; 6; 3; 12; 3 [hp_X]/m
57520-0614_1f829e1b-1def-47a7-93bf-1e49f29dd0d8 57520-0614 HUMAN OTC DRUG
Mag Phos "Magnesia phosphorica," PELLET ORAL 20110623
UNAPPROVED HOMEOPATHIC Apotheca Company "MAGNESIUM PHOSPHATE, DI
BASIC TRIHYDRATE" 12 [hp_X]/g
57520-0615_ef9158a2-df6c-4c03-9909-b524a0bdc12b 57520-0615 HUMAN OTC DRUG
Nicotinum "Nicotinum," LIQUID ORAL 20110317
UNAPPROVED HOMEOPATHIC Apotheca Company NICOTINE 6
[hp_X]/mL
57520-0618_62c3e794-4421-4bc1-8b72-3ad9eefa26c8 57520-0618 HUMAN OTC DRUG
[hp_X]/g
57520-0620_2e4690dd-2e09-4765-8f3b-6ef237b7e336 57520-0620 HUMAN OTC DRUG
Belladonna "Belladonna," PELLET ORAL 20110623
UNAPPROVED HOMEOPATHIC Apotheca Company ATROPA BELLADONNA
12 [hp_X]/g
57520-0621_49621ee7-1b8f-421d-9ac2-423f9bcabda6 57520-0621 HUMAN OTC DRUG
Tendon Rescue "Bryonia , Ruta graveolens, Bellis perennis, Argentum me
tallicum," GEL TOPICAL 20111024 UNAPPROVED HOMEOPATHIC
ERING TOP; SILVER 6; 3; 3; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g
57520-0623_236b803d-bb04-4c52-99ba-237a7a566ae0 57520-0623 HUMAN OTC DRUG
Chamomilla "Chamomilla," PELLET ORAL 20110621
UNAPPROVED HOMEOPATHIC Apotheca Company CHAMOMILE 12
[hp_X]/g
57520-0624_ce6cb639-d12e-4880-a19b-ad2f75d8202a 57520-0624 HUMAN OTC DRUG
Gelsemium "Gelsemium sempervirens," PELLET ORAL 20110623
UNAPPROVED HOMEOPATHIC Apotheca Company GELSEMIUM SEMPERVIRENS R
OOT 12 [hp_X]/g
57520-0625_d8ec7d5d-a1e9-4c9f-b978-851688ec1b33 57520-0625 HUMAN OTC DRUG
Ignatia Emotional Stress "Ignatia amara," PELLET ORAL
STRYCHNOS IGNATII SEED 12 [hp_X]/g
57520-0626_b6619b24-f973-4c1e-a529-3b03be199b97 57520-0626 HUMAN OTC DRUG
Ipecac "Ipecacuanha," PELLET ORAL 20110621 UNAPPROV
ED HOMEOPATHIC Apotheca Company IPECAC 12 [hp_X]/g
57520-0628_e311bbb1-0dde-4d27-9c34-0403e00ed085 57520-0628 HUMAN OTC DRUG
57520-0629_b7735057-75ab-4ef6-a443-9f94adfdd285 57520-0629 HUMAN OTC DRUG
Pulsatilla "Pulsatilla," PELLET ORAL 20110623
UNAPPROVED HOMEOPATHIC Apotheca Company PULSATILLA VULGARIS
12 [hp_X]/g
57520-0630_01c74b2c-525e-44aa-bbd3-68a0ce135c64 57520-0630 HUMAN OTC DRUG
57520-0632_a93042a6-ba5a-4c6e-8ac9-c1f6f9e16c13 57520-0632 HUMAN OTC DRUG
Candida "Candida albicans," LIQUID ORAL 20110211
30 [hp_C]/mL
57520-0633_b6acb030-5212-4aec-a9d4-088d1cd78270 57520-0633 HUMAN OTC DRUG
HZ HP "Lycopodium clavatum, Natrum muriaticum, Nitricum acidum, Ranunc
ulus bulbosus, Rhus toxicodendron, Sepia, Thuja occidenalis," LIQUID ORAL
LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; RANUNCULUS BULBOSUS; SEPIA OFFICINALIS J
UICE; SODIUM CHLORIDE; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LE
AF 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/
57520-0634_88c61bae-4915-4af0-bfe5-2f435998481a 57520-0634 HUMAN OTC DRUG
Colloidal Silver "Colloidal silver," LIQUID ORAL 20110301
UNAPPROVED HOMEOPATHIC Apotheca Company SILVER 12 [hp_X]/m
L
57520-0635_30989d1c-fcdc-4e59-a243-e48886c6ecd2 57520-0635 HUMAN OTC DRUG
Leg Cramp Relief "Causticum, Colocynthis, Cuprum metallicum, Magn
esia phosphorica, Phytolacca decandra, Rhus toxicodendron, Stannum metallicum, V
eratrum album," TABLET ORAL 20110606 UNAPPROVED HOMEOPATHIC
Apotheca Company "CAUSTICUM; CITRULLUS COLOCYNTHIS FRUIT PULP; COPPER; MA
GNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PHYTOLACCA AMERICANA ROOT; TIN; TOXICODEN
DRON PUBESCENS LEAF; VERATRUM ALBUM ROOT" 30; 30; 30; 30; 30; 30; 30; 30
[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
57520-0636_92a7ba30-b54c-4446-88c9-f0c946a5e85d 57520-0636 HUMAN OTC DRUG
Bio Pine "Pine," LIQUID ORAL 20110225 UNAPPROV
ED HOMEOPATHIC Apotheca Company PINUS SYLVESTRIS FLOWERING TOP
200 [hp_C]/mL
57520-0637_da8e0b11-fa2d-4a48-a916-e92ca61aea26 57520-0637 HUMAN OTC DRUG
Endopure Testos for Men "DNA, RNA, Cortisol, Glandula suprarenalis, Hypo
thalamus, Pituitary, Prostate, Testosterone, Chelidonium majus, Sabal serrulata,
Thuja occidentalis," LIQUID ORAL 20110316 UNAPPROVED HOMEO
PATHIC Apotheca Company CHELIDONIUM MAJUS; HERRING SPERM DNA; HY
DROCORTISONE; SACCHAROMYCES CEREVISIAE RNA; SAW PALMETTO; SUS SCROFA ADRENAL GLA
ND; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PITUITARY GLAND; SUS SCROFA PROSTATE; TE
STOSTERONE; THUJA OCCIDENTALIS LEAFY TWIG 12; 6; 6; 6; 12; 6; 6; 6; 6; 12;
30 [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]
57520-0638_d23d7d2c-5a16-43b6-afd6-985b54cbc3f0 57520-0638 HUMAN OTC DRUG
Testosterone "Testosterone," TABLET ORAL 20110607
UNAPPROVED HOMEOPATHIC Apotheca Company TESTOSTERONE 30
[hp_X]/1
57520-0639_14864dd4-c0a1-4ab8-a9b2-348d36fd5309 57520-0639 HUMAN OTC DRUG
Dr Cs Weight Maintenance "Chelidonium majus, Fucus vesiculosus, C
yanocobalamin, Spongia tosta, Thea sinensis, Calcarea phosphorica, Calcarea fluo
rica, Kali phosphoricum, Natrum sulphuricum, Pulsatilla, Lycopodium clavatum, Ca
l" LIQUID ORAL 20110715 UNAPPROVED HOMEOPATHIC
Apotheca Company "CALCIUM FLUORIDE; CHELIDONIUM MAJUS; CYANOCOBALAMIN; FU
CUS VESICULOSUS; GRAPHITE; LYCOPODIUM CLAVATUM SPORE; OYSTER SHELL CALCIUM CARBO
NATE, CRUDE; POTASSIUM PHOSPHATE, DIBASIC; PULSATILLA VULGARIS; SODIUM SULFATE;
SPONGIA OFFICINALIS SKELETON, ROASTED; SULFUR; TEA LEAF OIL; TRIBASIC CALCIUM PH
OSPHATE" 12; 6; 6; 6; 30; 30; 30; 12; 12; 12; 6; 30; 8; 12 [hp_X]/m
57520-0640_c00718cc-3010-4db6-b75f-0da4e88c1b83 57520-0640 HUMAN OTC DRUG
Melatonin Forte "Melatonin, Nadidum, Niacin, Pyridoxinum hydrochloricum,
Zincum sulphuricum, Hypothalamus, Lithium carbonicum, Magnesia carbonica, Pinea
l, Pituitary," SPRAY ORAL 20110818 UNAPPROVED HOMEOPATHIC
Apotheca Company BOS TAURUS HYPOTHALAMUS; LITHIUM CARBONATE; MAGNESIUM CA
RBONATE; MELATONIN; NADIDE; NIACIN; PYRIDOXINE HYDROCHLORIDE; SUS SCROFA PINEAL
GLAND; SUS SCROFA PITUITARY GLAND; ZINC SULFATE HEPTAHYDRATE 8; 8; 8; 6; 6; 6
57520-0642_4d68681b-9688-45b2-acdd-e1656ad685e6 57520-0642 HUMAN OTC DRUG
Multi Flower "Agrimony, Aspen, Beech, Centaury, Cerato, Cherry Plum,
Chestnut bud, Chicory, Clematis, Crab apple, Elm, Gentian, Gorse, Heather, Holly
Apotheca Company AESCULUS CARNEA FLOWER; AESCULUS HIPPOCASTANUM FLOWER; A
GRIMONIA EUPATORIA FLOWERING TOP; BROMUS RAMOSUS FLOWER; CALLUNA VULGARIS FLOWER
ING TOP; CARPINUS BETULUS FLOWER; CASTANEA SATIVA FLOWER; CENTAURIUM ERYTHRAEA F
LOWER; CERATOSTIGMA WILLMOTTIANUM FLOWER; CICHORIUM INTYBUS FLOWER; CLEMATIS VIT
ALBA FLOWER; FAGUS SYLVATICA FLOWERING TOP; GENTIANELLA AMARELLA FLOWER; HELIANT
HEMUM NUMMULARIUM FLOWER; ILEX AQUIFOLIUM FLOWERING TOP; IMPATIENS GLANDULIFERA
FLOWER; LARIX DECIDUA FLOWERING TOP; LONICERA CAPRIFOLIUM FLOWER; MALUS SYLVESTR
IS FLOWER; MIMULUS GUTTATUS FLOWERING TOP; OLEA EUROPAEA FLOWER; ORNITHOGALUM UM
BELLATUM; PINUS SYLVESTRIS FLOWERING TOP; POPULUS TREMULA FLOWERING TOP; PRUNUS
CERASIFERA FLOWER; QUERCUS ROBUR FLOWER; ROSA CANINA FLOWER; SALIX ALBA FLOWERIN
G TOP; SCLERANTHUS ANNUUS FLOWERING TOP; SINAPIS ARVENSIS FLOWERING/FRUITING TOP
; ULEX EUROPAEUS FLOWER; ULMUS PROCERA FLOWERING TWIG; VERBENA OFFICINALIS FLOWE
RING TOP; VITIS VINIFERA FLOWERING TOP; WATER 30; 30; 30; 30; 30; 30; 30; 30;
30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30;
mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL;
[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [h
]/mL; [hp_C]/mL
57520-0643_3cb092b0-440a-43bb-ac0c-9aa272b8540f 57520-0643 HUMAN OTC DRUG
Rescue 5 "Cherry plum, Clematis, Impatiens, Rock rose, Star of bethlehem,
ER 30; 30; 30; 30; 30 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_
C]/mL
57520-0644_d8e0ad5f-2735-4737-8b8d-4386fc3eeda9 57520-0644 HUMAN OTC DRUG
Renstat "Berberis vulgaris, Uva ursi, Sabal serrulata, Petroselinum sati
vum, Cantharis, Mercurius corrosivus, Solidago virgaurea, Sarsaparilla, Lithium
carbonicum, Pareire brava," LIQUID ORAL 20110302 UNAPPROV
ED HOMEOPATHIC Apotheca Company ARCTOSTAPHYLOS UVA-URSI LEAF; BE
RBERIS VULGARIS ROOT BARK; CHONDRODENDRON TOMENTOSUM ROOT; LITHIUM CARBONATE; LY
TTA VESICATORIA; MERCURIC CHLORIDE; PETROSELINUM CRISPUM; SARSAPARILLA ROOT; SAW
PALMETTO; SOLIDAGO VIRGAUREA FLOWERING TOP 3; 3; 12; 12; 12; 12; 3; 12; 3;
57520-0645_eaac4da6-2987-4d11-92e7-b37f578b0797 57520-0645 HUMAN OTC DRUG
Platinum for Men "Cyanocobalamin, Glandula suprarenalis suis, Kal
i carbonicum, L-carnitine, L-glutamine, L-ornithine, L-tryptophan, L-tyrosine, O
rchitinum." LIQUID ORAL 20110303 UNAPPROVED HOMEOPATHIC
Apotheca Company CARNITINE; CYANOCOBALAMIN; GLUTAMINE; HUMAN CHORIONIC GO
NADOTROPIN; LYCOPODIUM CLAVATUM SPORE; ORNITHINE; POTASSIUM CARBONATE; SUS SCROF
A ADRENAL GLAND; SUS SCROFA TESTICLE; SUS SCROFA THYROID; TRYPTOPHAN; TYROSINE
[hp_X]/mL
57520-0646_d5abf2e7-2d35-405c-8e6a-f20fe1c5a867 57520-0646 HUMAN OTC DRUG
Gold "L-carnitine, L-glutamine, L-ornithine, L-tryptophan, L-tyrosine
, Human chorionic gonadotropin," LIQUID ORAL 20110303
UNAPPROVED HOMEOPATHIC Apotheca Company CARNITINE; GLUTAMINE; HU
MAN CHORIONIC GONADOTROPIN; ORNITHINE; TRYPTOPHAN; TYROSINE 6; 6; 60; 6; 6;
6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0647_cff86752-795b-479e-bb47-212a2e09654a 57520-0647 HUMAN OTC DRUG
Platinum for Women "Cyanocobalamin, Glandula suprarenalis suis, Kal
i carbonicum, L-carnitine, L-glutamine, L -ornithine, L-tryptophan, L-tyrosine,"
Company "CYANOCOBALAMIN; GLUTAMINE; HUMAN CHORIONIC GONADOTROPIN; LEVOCA
RNITINE; ORNITHINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM CARBONATE;
SUS SCROFA ADRENAL GLAND; SUS SCROFA OVARY; SUS SCROFA THYROID; TRYPTOPHAN; TYRO
SINE" 6; 6; 60; 6; 6; 12; 6; 6; 6; 8; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL;
p_X]/mL; [hp_X]/mL
57520-0648_9da92979-e839-4eee-a1f6-5038bde81461 57520-0648 HUMAN OTC DRUG
Triple Potency HGH "Hepar, Human growth hormone, Pituitarum,"
Company PORK LIVER; SOMATROPIN; SUS SCROFA PITUITARY GLAND 6; 30; 3
0 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0651_f60c267a-5ed2-445d-a920-53d9a133204f 57520-0651 HUMAN OTC DRUG
Allergy Rescue 1 "Allium cepa, Ambrosia artemisiaefolia, Apis mel
lifica, Arsenicum album, Euphrasia officinalis, Nux vomica, Phosphorus, Pulsatil
la, Solidago virgaurea, Sulphur," LIQUID ORAL 20110407
APIS MELLIFERA; ARSENIC TRIOXIDE; EUPHRASIA STRICTA; ONION; PHOSPHORUS; PULSATI
LLA VULGARIS; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; SULFU
R 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL;
57520-0652_ad3559fd-b3d6-4ecb-a88e-5bf112abbe50 57520-0652 HUMAN OTC DRUG
Allergy Rescue 2 "Chelidonium majus, Echinacea, Gentiana lutea, Arsenicum
album, Carbo vegetalilis, Lycopodium clavatum, Nux vomica, Phosphorus, Pulsatil
la," LIQUID ORAL 20110330 UNAPPROVED HOMEOPATHIC
Apotheca Company ACTIVATED CHARCOAL; ARSENIC TRIOXIDE; CHELIDONIUM MAJUS;
ECHINACEA; GENTIANA LUTEA ROOT; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PULSATIL
LA VULGARIS; STRYCHNOS NUX-VOMICA SEED 12; 12; 3; 3; 3; 12; 12; 12; 12 [hp_X]/m
[hp_X]/mL
57520-0653_71f8568e-8431-4cea-9a60-fe32f5d458fa 57520-0653 HUMAN OTC DRUG
Allergy Rescue 3 "Baptisia tinctoria, Echinacea, Allium cepa, Ambrosia ar
temisiaefolia, Arsenicum album, Euphrasia officinalis, Natrum sulphuricum, Nux v
omica, Phosphorus, Pulsatilla, Solidago virgaurea, Sulphur," LIQUID ORAL
AMBROSIA ARTEMISIIFOLIA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; ECHINACEA; E
UPHRASIA STRICTA; ONION; PHOSPHORUS; PULSATILLA VULGARIS; SODIUM SULFATE; SOLIDA
GO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; SULFUR 12; 12; 3; 3; 12
mL
57520-0654_782a5fd1-1b9d-462e-9317-0a793ee77128 57520-0654 HUMAN OTC DRUG
Sinus Rescue 1 "Arsenicum album, Hepar sulphuris calcareum, Hydrastis c
anadensis, Kali bichromicum, Lycopodium clavatum, Mercurius solubilis, Natrum mu
riaticum, Phosphorus, Pulsatilla, Sepia, Thuja occidentalis," LIQUID ORAL
ARSENIC TRIOXIDE; CALCIUM SULFIDE; GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; MERCUR
IUS SOLUBILIS; PHOSPHORUS; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SEPIA OFFI
CINALIS JUICE; SODIUM CHLORIDE; THUJA OCCIDENTALIS LEAFY TWIG 30; 30; 30; 30;
57520-0655_0e0802ba-ab8e-4349-a180-95461c427ade 57520-0655 HUMAN OTC DRUG
Sinus Rescue 2 "Echinacea, Hydrastis canadensis, Allium cepa, Ambrosia
artemisiaefolia, Arsenicum album, Kali bichromicum, Nux moschata, Pulsatilla, Se
pia, Solidago virgaurea," LIQUID ORAL 20110330 UNAPPROV
ED HOMEOPATHIC Apotheca Company AMBROSIA ARTEMISIIFOLIA; ARSENIC
TRIOXIDE; ECHINACEA; GOLDENSEAL; NUTMEG; ONION; POTASSIUM DICHROMATE; PULSATILL
A VULGARIS; SEPIA OFFICINALIS JUICE; SOLIDAGO VIRGAUREA FLOWERING TOP 12; 12;
57520-0656_06ba3f44-3685-40aa-b49d-a9164613e832 57520-0656 HUMAN OTC DRUG
Bacteriostat "Baptisia tinctoria, Echinacea, Phytolacca decandra, Aco
, Phosphorus," LIQUID ORAL 20110330 UNAPPROVED HOMEOPATHIC
BAPTISIA TINCTORIA ROOT; ECHINACEA; FERRUM PHOSPHORICUM; LACHESIS MUTA VENOM; PH
OSPHORUS; PHYTOLACCA AMERICANA ROOT 12; 12; 12; 3; 3; 12; 12; 12; 3 [hp_X]/m
[hp_X]/mL
57520-0657_a9a21507-d564-4f36-8745-63e77f473978 57520-0657 HUMAN OTC DRUG
Virostat "Echinacea, Hydrastis canadensis, Lomatium, Aconitum nap
ellus, Arsenicum album, Belladonna, Eupatorium perfoliatum, Gelsemium sempervire
ns, Lachesis mutus, Rhus toxicodendron, Pyrogenium," LIQUID ORAL 20110330
IC TRIOXIDE; ATROPA BELLADONNA; ECHINACEA; EUPATORIUM PERFOLIATUM FLOWERING TOP;
GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; LACHESIS MUTA VENOM; LOMATIUM DISSECTU
M ROOT; RANCID BEEF; TOXICODENDRON PUBESCENS LEAF 12; 12; 12; 3; 12; 12; 3
57520-0659_f7082951-8818-47f2-ab7e-c88844135757 57520-0659 HUMAN OTC DRUG
Bio Cherry Plum "Cherry plum," LIQUID ORAL 20110316
UNAPPROVED HOMEOPATHIC Apotheca Company PRUNUS CERASIFERA FLOWER
200 [hp_C]/mL
57520-0660_3c540ecc-eb30-43b7-bfac-2f43ee5d1544 57520-0660 HUMAN OTC DRUG
Optimal Diet Plan "Fucus vesiculosus, Cyanocobalamin, Glandula sup
rarenalis, Hepar suis, L-carnitine, L-ornithine, Antimonium crudum, Thyroidinum,
Natrum sulphuricum, Pancreatinum, Hypothalamus," LIQUID ORAL 20110513
20160411 UNAPPROVED HOMEOPATHIC Apotheca Company ANTIMONY
TRISULFIDE; BOS TAURUS HYPOTHALAMUS; CARNITINE; CYANOCOBALAMIN; FUCUS VESICULOS
US; ORNITHINE; PANCRELIPASE; PORK LIVER; SODIUM SULFATE; SUS SCROFA ADRENAL GLAN
D; THYROID 8; 18; 30; 6; 2; 30; 12; 6; 10; 6; 8 [hp_X]/mL; [hp_X]/mL; [h
]/mL; [hp_X]/mL
57520-0661_e1f6cec1-6bf3-40e0-8f60-21b370b10dce 57520-0661 HUMAN OTC DRUG
Flu Rescue "Baptisia tinctoria, Echinacea, Hydrastis canadensis, Ph
ytolacca decandra, Arsenicum album, Bryonia, Eupatorium perfoliatum, Ferrum phos
phoricum," LIQUID ORAL 20110405 UNAPPROVED HOMEOPATHIC
Apotheca Company ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA
ROOT; ECHINACEA; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERRUM PHOSPHORICUM; GELS
EMIUM SEMPERVIRENS ROOT; GOLDENSEAL; IPECAC; PHYTOLACCA AMERICANA ROOT; TOXICODE
NDRON PUBESCENS LEAF 12; 3; 12; 3; 12; 12; 12; 3; 12; 3; 12 [hp_X]/mL; [hp_X
57520-0662_3f451e6f-56ce-49fa-bd5f-f415d8970608 57520-0662 HUMAN OTC DRUG
Infect Rescue "Aconitum napellus, Arsenicum album, Baptisia tinctoria,
Belladonna, Bryonia, Causticum, Echinacea, Eupatorium perfoliatum, Ferrum phosp
horicum, Gelsemium sempervirens, Hydrastis canadensis," LIQUID ORAL 20110401
IC TRIOXIDE; ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CAUS
TICUM; COMFREY ROOT; DEFIBROTIDE (BOVINE LUNG); ECHINACEA; EUPATORIUM PERFOLIATU
M FLOWERING TOP; FERRUM PHOSPHORICUM; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; H
YPERICUM PERFORATUM; LACHESIS MUTA VENOM; LOBELIA INFLATA; LOMATIUM DISSECTUM RO
OT; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; POTASSIUM CARBONATE; PULSATILLA VULGA
RIS; RANCID BEEF; SILICON DIOXIDE; SODIUM SULFATE; SULFUR; TOXICODENDRON PUBESCE
NS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30;
57520-0663_401b45b7-2f40-43fe-970d-96c5842f4f43 57520-0663 HUMAN OTC DRUG
Flutone "Baptisia tinctoria, Echinacea, Hydrastis canadensis, Phytolacca
decandra, Arsenicum album, Bryonia, Eupatorium perfoliatum, Ferrum phosphoricum
, Gelsemium sempervirens, Ipecacuanha, Rhus toxicodendron" LIQUID ORAL
ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; ECHINACEA; EUPATOR
IUM PERFOLIATUM FLOWERING TOP; FERRUM PHOSPHORICUM; GELSEMIUM SEMPERVIRENS ROOT;
GOLDENSEAL; IPECAC; PHYTOLACCA AMERICANA ROOT; TOXICODENDRON PUBESCENS LEAF
57520-0667_626c0d6b-c4f5-4317-af86-d4e1a454c22c 57520-0667 HUMAN OTC DRUG
DV HP "Calcarea carbonica, Chenopodium anthelminticum, Cocculus indicu
s, Conium maculatum, Nux Vomica, Phosphorus, Pulsatilla, Silicea," LIQUID
"ANAMIRTA COCCULUS SEED; CHENOPODIUM AMBROSIOIDES; CONIUM MACULATUM FLOWERING TO
P; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PULSATILLA VULGARIS; SILIC
ON DIOXIDE; STRYCHNOS NUX-VOMICA SEED" 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/m
57520-0669_55073774-dde9-490f-83eb-03a3decfda2f 57520-0669 HUMAN OTC DRUG
Bio Centaury "Centaury," LIQUID ORAL 20110412
UNAPPROVED HOMEOPATHIC Apotheca Company CENTAURIUM ERYTHRAEA FLO
WER 200 [hp_C]/mL
57520-0670_23bc0b01-4b43-4b88-9d47-937393ba719a 57520-0670 HUMAN OTC DRUG
Bio Hornbeam Hornbeam LIQUID ORAL 20110407
UNAPPROVED HOMEOPATHIC Apotheca Company CARPINUS BETULUS FLOWER
200 [hp_C]/mL
57520-0672_4272dbf4-00c8-4fa0-8b6d-3b41501f8a86 57520-0672 HUMAN OTC DRUG
Bio Electrolyte "Boricum gluconicum, Calcarea gluconica, Chromium glucon
icum, Cobaltum gluconicum, Cuprum gluconicum, Ferrum gluconicum, Kali gluconicum
, Magnesia gluconica, Manganum gluconicum, Natrum gluconicum, Nic" LIQUID
"BORON GLUCONATE; CALCIUM GLUCONATE; CHROMIUM GLUCONATE; COBALTOUS GLUCONATE; CO
PPER GLUCONATE; FERROUS GLUCONATE; MAGNESIUM GLUCONATE; MANGANESE GLUCONATE; NIC
KEL GLUCONATE; POTASSIUM GLUCONATE; POTASSIUM PHOSPHATE, DIBASIC; SELENIUM DIOXI
DE; SODIUM GLUCONATE; TRIBASIC CALCIUM PHOSPHATE; VANADIUM; ZINC GLUCONATE"
6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 6; 6; 9; 8; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL;
57520-0675_85627e48-e2ff-4a16-a5a5-44320a259b40 57520-0675 HUMAN OTC DRUG
Virustat "Echinacea, Hydrastit canadensis, Lomatium, Aconitum nap
IC TRIOXIDE; ATROPA BELLADONNA; ECHINACEA; EUPATORIUM PERFOLIATUM FLOWERING TOP;
GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; LACHESIS MUTA VENOM; LOMATIUM DISSECTU
M ROOT; RANCID BEEF; TOXICODENDRON PUBESCENS LEAF 12; 12; 12; 3; 12; 12; 3
57520-0676_ad79bd54-bfdf-4856-9c26-c0ae1987f29a 57520-0676 HUMAN OTC DRUG
Fucus Vesiculosus "Fucus vesiculosus," LIQUID ORAL 20110411
UNAPPROVED HOMEOPATHIC Apotheca Company FUCUS VESICULOSUS
30 [hp_C]/mL
57520-0677_90582206-0a8e-421e-9c1c-364461540168 57520-0677 HUMAN OTC DRUG
Cesium Chloride Cesium chloride LIQUID ORAL 20110414
UNAPPROVED HOMEOPATHIC Apotheca Company CESIUM CHLORIDE 6
[hp_X]/mL
57520-0684_c23d41be-892e-4002-90e2-2d65798b8c7f 57520-0684 HUMAN OTC DRUG
Grippe HP "Aconitum napellus, Arsenicum album, Baptisia tinctoris, Bellado
nna, Bryonia, Eupatorium perfoliatum, Ferrum phosphoricum, Gelsemium semperviren
s," LIQUID ORAL 20110428 UNAPPROVED HOMEOPATHIC
BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP
; FERRUM PHOSPHORICUM; GELSEMIUM SEMPERVIRENS ROOT 30; 30; 30; 30; 30; 30;
/mL; [hp_X]/mL
57520-0685_faad6f8c-738c-4423-91d8-7236eaea1168 57520-0685 HUMAN OTC DRUG
Bio Honeysuckle "Honeysuckle," LIQUID ORAL 20110428
UNAPPROVED HOMEOPATHIC Apotheca Company LONICERA CAPRIFOLIUM FLO
WER 200 [hp_C]/mL
57520-0686_5cc8d822-da65-49fb-ba90-915b7a11eebc 57520-0686 HUMAN OTC DRUG
Bio Vine "Vine," LIQUID ORAL 20110428 UNAPPROV
ED HOMEOPATHIC Apotheca Company VITIS VINIFERA FLOWERING TOP
200 [hp_C]/mL
57520-0691_8aeaaaa4-fb4c-4006-8a9f-eeadc4848210 57520-0691 HUMAN OTC DRUG
Optimal HCG Diet Plan "Fucus vesiculosus, Cyanocobalamin, Glandula sup
rarenalis suis, Hepar suis, L-carnitine, L-ornithine, Antimonium crudum, Thyroid
inum suis," LIQUID ORAL 20130326 20160726 UNAPPROVED HOMEO
PATHIC Apotheca Company ANTIMONY TRISULFIDE; CYANOCOBALAMIN; FUC
US VESICULOSUS; LEVOCARNITINE; ORNITHINE; PANCRELIPASE; PORK LIVER; SODIUM SULFA
TE; SUS SCROFA ADRENAL GLAND; SUS SCROFA HYPOTHALAMUS; SUS SCROFA THYROID
57520-0695_30fd886c-f605-4121-8d58-f8ccc933691b 57520-0695 HUMAN OTC DRUG
Neuroforce "Echinacea, Hypericum perforatum, Symphytum officinale,
Arnica montana, Agaricus muscarius, Arsenicum album, Gelsemium sempervirens, Plu
mbum metallicum, Rhus toxicodendron," LIQUID ORAL 20110519
UNAPPROVED HOMEOPATHIC Apotheca Company AMANITA MUSCARIA VAR. MU
SCARIA; ARNICA MONTANA; ARSENIC TRIOXIDE; COMFREY ROOT; ECHINACEA; GELSEMIUM SEM
PERVIRENS ROOT; HYPERICUM PERFORATUM; LEAD; TOXICODENDRON PUBESCENS LEAF
57520-0696_fc4e521a-e12b-4f57-b321-eb60f93f3fb3 57520-0696 HUMAN OTC DRUG
Pollen Mix "Goldenrod, Red clover, Alfalfa, Sheep sorrel, Yellow do
ck, Kentucky bluegrass, Orchard grass, Redtop grass, Timothy grass, Giant ragwee
d, False ragweed, Short ragweed," LIQUID ORAL 20110613
UNAPPROVED HOMEOPATHIC Apotheca Company ACER NEGUNDO POLLEN; AGR
OSTIS GIGANTEA POLLEN; ALFALFA; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA ARTEMISII
FOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; BETULA OCCI
DENTALIS POLLEN; CARYA OVATA POLLEN; DACTYLIS GLOMERATA POLLEN; FAGUS GRANDIFOLI
A POLLEN; FRAXINUS VELUTINA POLLEN; JUGLANS NIGRA POLLEN; PHLEUM PRATENSE POLLEN
; PLATANUS OCCIDENTALIS POLLEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN;
QUERCUS RUBRA POLLEN; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN; SALIX NIGRA
POLLEN; SOLIDAGO CANADENSIS POLLEN; TRIFOLIUM PRATENSE POLLEN; ULMUS AMERICANA
POLLEN 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30;
57520-0700_6d184d71-8486-4f20-8f27-5508b1baef9f 57520-0700 HUMAN OTC DRUG
Arterioforce I "Arnica montana, Lilium tigrinum, Aurum muriaticum, Cact
us grandiflorus, Digitalis purpurea, Glonoinum, Nux vomica, Veratrum album,"
Company ARNICA MONTANA; DIGITALIS; GOLD TRICHLORIDE; LILIUM LANCIFOLIUM
BULB; NITROGLYCERIN; SELENICEREUS GRANDIFLORUS STEM; STRYCHNOS NUX-VOMICA SEED;
VERATRUM ALBUM ROOT 3; 12; 12; 4; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [h
57520-0701_e148766d-e40d-4464-b0a1-af4e544189f7 57520-0701 HUMAN OTC DRUG
Acetylcholine chloride "Acetylcholine chloride," LIQUID ORAL
ACETYLCHOLINE CHLORIDE 30 [hp_C]/mL
57520-0702_f156f510-b1e8-4be5-b135-e5573fbe86f0 57520-0702 HUMAN OTC DRUG
Trauma Free "Symphytum officinale, Bellis perennis, Hypericum perfor
atum, Magnesia phosphorica, Ruta graveolens, Arnica montana," LIQUID ORAL
"ARNICA MONTANA; BELLIS PERENNIS; COMFREY ROOT; HYPERICUM PERFORATUM; MAGNESIUM
PHOSPHATE, DIBASIC TRIHYDRATE; RUTA GRAVEOLENS FLOWERING TOP" 200; 12; 3; 12;
30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0703_187b89d7-b6fb-4138-8ed0-995c6f0e1c92 57520-0703 HUMAN OTC DRUG
NAJA Forte X "Naja tripudians," LIQUID ORAL 20110602
UNAPPROVED HOMEOPATHIC Apotheca Company NAJA NAJA VENOM 30
[hp_X]/mL
57520-0704_637717bc-6d10-4524-baff-324f3f0f32ef 57520-0704 HUMAN OTC DRUG
Rheumaforce "Chondrus crispus, Cimicifuga racemosa, Spiraea ulmaria,
Symphytum officinale, Trifolium pratense, Urtica urens, Xanthoxylum fraxineum,
Colchicum autumnale, Ferrum phosphoricum, Formica rufa," LIQUID ORAL
BLACK COHOSH; CHONDRUS CRISPUS; COLCHICUM AUTUMNALE BULB; COMFREY ROOT; FERRUM P
HOSPHORICUM; FILIPENDULA ULMARIA ROOT; FORMICA RUFA; LITHIUM CARBONATE; RHODODEN
DRON AUREUM LEAF; SODIUM SULFATE; TOXICODENDRON PUBESCENS LEAF; TRIFOLIUM PRATEN
SE FLOWER; URTICA URENS; ZANTHOXYLUM AMERICANUM BARK 3; 3; 12; 3; 12; 3; 12;
X]/mL; [hp_X]/mL
57520-0705_b9df1e34-aee7-4406-9da3-ecb9d28bd937 57520-0705 HUMAN OTC DRUG
Sycosis Complex "Zincum metallicum, Silicea, Sulphur, Thuja occidentalis
Apotheca Company SILICON DIOXIDE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG;
ZINC 30; 30; 30; 12 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL
57520-0708_d39b41e9-a507-4e2f-a339-1ced2a8494c7 57520-0708 HUMAN OTC DRUG
Pneumoforce "Althaea officinalis, Natrum carbonicum, Rheum officinal
s, Verbascum thapsus, Zingiber officinale, Aconitum napellus, Drosera rotundifol
ia, Kali bichromicum, Lobelia inflata, Phosphorus," LIQUID ORAL 20110525
UNAPPROVED HOMEOPATHIC Apotheca Company ACONITUM NAPELLUS; ALTHA
EA OFFICINALIS ROOT; DROSERA ROTUNDIFOLIA; GINGER; LOBELIA INFLATA; PHOSPHORUS;
POTASSIUM DICHROMATE; RHEUM OFFICINALE ROOT; SODIUM CARBONATE; VERBASCUM THAPSUS
57520-0710_51a649b9-ef27-4816-a50a-982233340909 57520-0710 HUMAN OTC DRUG
Acne "Kali bromatum, Natrum bromatum, Niccolum sulphuricum, Sulphur,
Hepar suphuris calcareum," TABLET ORAL 20110715 UNAPPROV
ED HOMEOPATHIC Apotheca Company CALCIUM SULFIDE; NICKEL SULFATE
HEXAHYDRATE; POTASSIUM BROMIDE; SODIUM BROMIDE; SULFUR 9; 6; 1; 2; 6 [hp_X]/1
; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
57520-0711_eda9f5bc-1a20-4591-b1c1-3b015952c8db 57520-0711 HUMAN OTC DRUG
Acne "Kali bromatum, Natrum bromatum, Niccolum sulphuricum, Sulphur,
Hepar sulphurs calcareum," TABLET ORAL 20110629 UNAPPROV
ED HOMEOPATHIC Apotheca Company CALCIUM SULFIDE; NICKEL SULFATE
HEXAHYDRATE; POTASSIUM BROMIDE; SODIUM BROMIDE; SULFUR 9; 6; 1; 2; 6 [hp_X]/1
; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
57520-0712_4cefb645-9980-44f7-8e11-794448d38366 57520-0712 HUMAN OTC DRUG
Loma Lux Psoriasis "Kali bromatum, Natrum sulphuricum, Niccolum Sul
phuricum, Kali sulphuricum, Zincum bromatum," LIQUID ORAL 20110705
UNAPPROVED HOMEOPATHIC Apotheca Company NICKEL SULFATE HEXAHYDRA
TE; POTASSIUM BROMIDE; POTASSIUM SULFATE; SODIUM BROMIDE; ZINC BROMIDE 3; 1; 4;
2; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0713_a4b3c89c-c5f6-4ca7-ad45-72942c86e512 57520-0713 HUMAN OTC DRUG
Loma Lux Psoriasis "Kali bromatum, Natrum bromatum, Niccolum sulphu
ricum, Kali sulphuricum, Zincum bromatum," LIQUID ORAL 20110707
UNAPPROVED HOMEOPATHIC Apotheca Company NICKEL SULFATE HEXAHYDRA
TE; POTASSIUM BROMIDE; POTASSIUM SULFATE; SODIUM BROMIDE; ZINC BROMIDE 3; 1; 4;
2; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0719_24fd40f1-cff3-49b4-a91c-594515b00dfe 57520-0719 HUMAN OTC DRUG
Dr Wises Gluten Relief "Lycopodium clavatum, Pulsatilla," CAPSULE
LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS 12; 12 [hp_X]/1; [hp_X]/1
57520-0725_f17551b4-fe82-4f07-9af9-b28905b394e4 57520-0725 HUMAN OTC DRUG
Epinephrine "Adrenalinum," LIQUID ORAL 20110707
UNAPPROVED HOMEOPATHIC Apotheca Company EPINEPHRINE 200
[hp_C]/mL
57520-0726_adfd6a4d-79b0-4264-aeec-8782ca97f4c0 57520-0726 HUMAN OTC DRUG
Ileocecal Valve Support "Iodium, Pituitarium posterium, Thyroidinum, Gla
ndula suprarenalis suis, Fel tauri, Taraxacum officinale, Bryonia, Carbo vegetab
ilis, Colocynthis, Indolum, Lycopodium clavatum, Mercurius corrosivus, Nux vomic
a, Phosphorus, Pulsatilla," LIQUID ORAL 20110706 UNAPPROV
ED HOMEOPATHIC Apotheca Company "ACTIVATED CHARCOAL; BOS TAURUS
BILE; BRYONIA ALBA ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; INDOLE; IODINE; LYCOP
ODIUM CLAVATUM SPORE; MERCURIC CHLORIDE; PHOSPHORUS; PULSATILLA VULGARIS; STRYCH
NOS NUX-VOMICA SEED; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; TARAX
ACUM OFFICINALE; THYROID, PORCINE" 30; 12; 30; 30; 30; 6; 30; 30; 30; 30; 3
0; 10; 8; 12; 8 [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL
; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [
hp_X]/mL; [hp_X]/mL
57520-0727_1680744b-22c6-47bf-8e3b-28aa9e483f1d 57520-0727 HUMAN OTC DRUG
Bryonia "Bryonia," PELLET ORAL 20110623 UNAPPROV
ED HOMEOPATHIC Apotheca Company BRYONIA ALBA ROOT 12
[hp_X]/g
57520-0729_6f1a558c-d67c-431a-81aa-cdcaa4770f59 57520-0729 HUMAN OTC DRUG
Melatonin "Melatonin," LIQUID ORAL 20110715
UNAPPROVED HOMEOPATHIC Apotheca Company MELATONIN 200
[hp_C]/mL
57520-0731_f16c19e4-786d-4a9a-b089-73d91e0cfe63 57520-0731 HUMAN OTC DRUG
Septaforce "Baptisia tinctoria, Echinacea, Arsenicum album, Chininu
m sulphuricum, Crotalus horridus, Lachesis mutus, Loxosceles reclusa, Secale cor
nutum, Tarentula cubensis, Latrodectus mactans, Anthracinum," LIQUID ORAL
"ARSENIC TRIOXIDE; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; BAPTISIA TINCTORIA ROO
T; CITHARACANTHUS SPINICRUS; CLAVICEPS PURPUREA SCLEROTIUM; CROTALUS HORRIDUS HO
RRIDUS VENOM; ECHINACEA, UNSPECIFIED; LACHESIS MUTA VENOM; LATRODECTUS MACTANS V
ENOM; LOXOSCELES RECLUSA; QUININE SULFATE" 12; 33; 3; 12; 12; 12; 3; 12; 30
; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0735_5bbd0bcc-ced6-4aaa-bf18-1baeba88477e 57520-0735 HUMAN OTC DRUG
Gallbladder Liver Meridian Opener "Arsenicum album, Berberis vulga
ris, Bryonia, Calcarea carbonica, Carduus marianus, Cinchona officinalis, Kali c
arbonicum, Lycopodium clavatum, Natrum sulphuricum, Nux vomica, Phosphorus,"
Company "ARSENIC TRIOXIDE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROO
T; CINCHONA OFFICINALIS BARK; LYCOPODIUM CLAVATUM SPORE; OYSTER SHELL CALCIUM CA
RBONATE, CRUDE; PHOSPHORUS; POTASSIUM CARBONATE; SILYBUM MARIANUM SEED; SODIUM S
ULFATE; STRYCHNOS NUX-VOMICA SEED" 30; 30; 30; 30; 30; 30; 30; 30; 30; 30;
57520-0736_5f0e0566-2539-4880-885d-c945da3b1a7f 57520-0736 HUMAN OTC DRUG
Gallic Acid "Gallicum acidum," LIQUID ORAL 20110715
UNAPPROVED HOMEOPATHIC Apotheca Company GALLIC ACID MONOHYDRATE
200 [hp_C]/mL
57520-0739_8335259d-1c94-4372-a5a6-36c49ad6adbf 57520-0739 HUMAN OTC DRUG
Tyramine "Tyramine," LIQUID ORAL 20110728
UNAPPROVED HOMEOPATHIC Apotheca Company TYRAMINE 200
[hp_C]/mL
57520-0740_ff8259f7-2cc1-4467-8f9b-57af2da0b69b 57520-0740 HUMAN OTC DRUG
DNA "DNA," LIQUID ORAL 20110801 UNAPPROVED HOMEO
PATHIC Apotheca Company HERRING SPERM DNA 12 [hp_X]/m
L
57520-0755_571b1382-1a64-4460-b29f-2d7df5a6054d 57520-0755 HUMAN OTC DRUG
[hp_C]/mL
57520-0756_edc177e9-3590-47c0-b26c-43b996579469 57520-0756 HUMAN OTC DRUG
Sinusitis "Pulsatilla, Plantago major, Euphorbium officinarum, Luf
fa operculata, Mercurius iodatus ruber, Mucosa nasalis suis, Argentum nitricum,
Hepar sulphuris calcareum, Calcarea carbonica, Natrum muriaticum," LIQUID
"CALCIUM SULFIDE; EUPHORBIA RESINIFERA RESIN; LUFFA OPERCULATA FRUIT; MERCURIC I
ODIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PLANTAGO MAJOR; PULSATILLA VULGARI
S; SILVER NITRATE; SINUSITISINUM; SODIUM CHLORIDE; SUS SCROFA NASAL MUCOSA"
57520-0757_84e65868-3a28-446a-9caf-dc8c781a4d39 57520-0757 HUMAN OTC DRUG
Lymph Rx "Ceanothus Americanus, Euphrasia Officinalis, Germanium Robertia
num," LIQUID ORAL 20110912 UNAPPROVED HOMEOPATHIC
Apotheca Company "ALTHAEA OFFICINALIS ROOT; APIS MELLIFERA; ARANEUS DIADE
MATUS; BARIUM CARBONATE; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; C
APSICUM; CEANOTHUS AMERICANUS LEAF; ECHINACEA, UNSPECIFIED; EQUISETUM HYEMALE; E
UPHRASIA STRICTA; FERROUS IODIDE; FUMARIA OFFICINALIS FLOWERING TOP; GENTIANA LU
TEA ROOT; GERANIUM ROBERTIANUM; JUGLANS REGIA FLOWERING TOP; MERCURIC CYANIDE; M
YOSOTIS ARVENSIS; PEUMUS BOLDUS LEAF; PHYTOLACCA AMERICANA ROOT; PINUS SYLVESTRI
S LEAFY TWIG; POTASSIUM IODIDE; RORIPPA NASTURTIUM-AQUATICUM; SCROPHULARIA NODOS
A; SMILAX REGELII ROOT; SODIUM SULFATE; SUS SCROFA PARATHYROID GLAND; SUS SCROFA
THYMUS; TEUCRIUM SCORODONIA FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; THYRO
ID, PORCINE; TRIBASIC CALCIUM PHOSPHATE; VERONICA OFFICINALIS FLOWERING TOP; VIS
CUM ALBUM FRUITING TOP" 1; 4; 12; 8; 8; 1; 3; 1; 1; 4; 1; 8; 1; 1; 1; 1; 8; 1; 1
; 3; 1; 1; 3; 1; 1; 4; 12; 12; 1; 1; 12; 8; 4; 3 [hp_X]/mL; [hp_X]/mL; [h
57520-0758_48379cba-deac-4a16-aee7-47c91edde5c2 57520-0758 HUMAN OTC DRUG
Weed Grass Antigens "Allium cepa, Arsenicum album, Nux vomica, Pulsa
tilla, Alfalfa, Amaranthus, Bamboo, Cocklebur, Dandelion, Goldenrod, Kentucky bl
ue, Lambs quarters," LIQUID ORAL 20110817 UNAPPROVED HOMEO
PATHIC Apotheca Company AGRIMONIA EUPATORIA FLOWERING TOP; AGROS
TIS GIGANTEA POLLEN; ALFALFA; ALLIUM CEPA WHOLE; AMARANTHUS PALMERI POLLEN; AMAR
ANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLEN; AMBROSIA PSILOSTACHYA POL
LEN; ANTHOXANTHUM ODORATUM POLLEN; ARSENIC TRIOXIDE; ARTEMISIA TRIDENTATA POLLEN
; ARTEMISIA VULGARIS POLLEN; BAMBUSA VULGARIS LEAF; CHENOPODIUM ALBUM POLLEN; DA
CTYLIS GLOMERATA POLLEN; FESTUCA PRATENSIS POLLEN; IVA ANGUSTIFOLIA POLLEN; IVA
ANNUA POLLEN; LOLIUM PERENNE POLLEN; OXALIS MONTANA LEAF; PHLEUM PRATENSE POLLEN
; POA PRATENSIS POLLEN; PULSATILLA VULGARIS; RED CLOVER; RUMEX CRISPUS POLLEN; S
OLIDAGO CANADENSIS FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINAL
E; TRIFOLIUM REPENS FLOWER 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12;
12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/m
57520-0763_44a89ef2-15b3-4b18-9cf8-13cdfba07fb7 57520-0763 HUMAN OTC DRUG
Chemtox "Berberis vulgaris, Glycyrrhiza glabra, Lappa major, Phytolacca
decandra, Stillingia sylvatica, Trifolium pratense, Glandula suprarenalis suis,
Hepar suis, Lymph suis, Thyroidinum suis, Belladonna, Iri" LIQUID ORAL
"ACETIC ACID; ARCTIUM LAPPA ROOT; ATROPA BELLADONNA; BENZOIC ACID; BENZYL ALCOHO
L; BERBERIS VULGARIS ROOT BARK; BORIC ACID; CHLORINE; CORTICOTROPIN; CORTISONE A
CETATE; ESTRONE; EUGENOL; GLYCYRRHIZA GLABRA; IRIDIUM; ISOPROPYL PALMITATE; LACT
IC ACID, DL-; LEAD; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; PETROLATUM; PHENYLBU
TAZONE; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; PORK LIVER; POTASSIUM SORBAT
E; RESORCINOL; SALICYLIC ACID; SELENIUM; SORBITOL; STEARYL ALCOHOL; STILLINGIA S
YLVATICA ROOT; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA ADRENAL GLAND; SUS SCROFA L
YMPH; SUS SCROFA THYROID; TRIFOLIUM PRATENSE FLOWER; XYLITOL" 200; 3; 12; 200;
200; 3; 200; 200; 200; 200; 200; 200; 3; 12; 200; 200; 200; 12; 12; 200; 200; 1
2; 3; 8; 200; 200; 200; 12; 200; 200; 3; 12; 8; 8; 8; 3; 200 [hp_X]/mL; [hp_X
57520-0764_60bb8396-c03c-4e68-a189-eab00e7d5a38 57520-0764 HUMAN OTC DRUG
Rheumatic Tonic "Ginkgo biloba, Dioscorea villosa, Glycyrrhiza glabra, V
iscum album, Pinus sylvestris, Apis mellifica, Dulcamara, Kalmia latifolia, Lyco
podium clavatum, Sulphur," LIQUID ORAL 20110819 UNAPPROV
ED HOMEOPATHIC Apotheca Company APIS MELLIFERA; DIOSCOREA VILLOS
A ROOT; GINKGO; GLYCYRRHIZA GLABRA; KALMIA LATIFOLIA LEAF; LYCOPODIUM CLAVATUM S
PORE; PINUS SYLVESTRIS FLOWERING TOP; SOLANUM DULCAMARA FLOWER; SULFUR; VISCUM A
LBUM FRUITING TOP 12; 1; 1; 3; 12; 12; 6; 12; 12; 3 [hp_X]/mL; [hp_X
L; [hp_X]/mL
57520-0769_56e87e84-a610-4895-8286-13419a3345cf 57520-0769 HUMAN OTC DRUG
Appetite Control "Thyroidinum, Cortisone aceticum, Anacardium ori
entale, Antimonium crudum, Ignatia amara, Natrum muriaticum, Staphysagria, Corti
sol," LIQUID ORAL 20110808 UNAPPROVED HOMEOPATHIC
Apotheca Company ANTIMONY TRISULFIDE; CORTISONE ACETATE; DELPHINIUM STAPH
ISAGRIA SEED; HYDROCORTISONE; SEMECARPUS ANACARDIUM JUICE; SODIUM CHLORIDE; STRY
CHNOS IGNATII SEED; THYROID 15; 15; 18; 30; 15; 15; 15; 12 [hp_C]/mL; [hp_C
]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL
57520-0770_e8b212c4-ea62-4c70-b5e0-0d1bec988623 57520-0770 HUMAN OTC DRUG
Dopamine "Dopamine," LIQUID ORAL 20110808
UNAPPROVED HOMEOPATHIC Apotheca Company DOPAMINE 200
[hp_C]/mL
57520-0774_65227c4a-c9c9-407b-bfdc-87e1f4b76957 57520-0774 HUMAN OTC DRUG
Borrelia Remedy "Borrelia burgdorferi," LIQUID ORAL 20110816
20170208 UNAPPROVED HOMEOPATHIC Apotheca Company BORRELIA
BURGDORFERI 1000 [hp_X]/mL
57520-0775_0b39058c-1682-4681-bb2d-0c3ab8793c4f 57520-0775 HUMAN OTC DRUG
Adrenal Support "Aralia quinquefolia , Humulus lupulus, Adrenalinum, Cor
tisone aceticum, Thyroidinum suis, Selenium metallicum, Arsenicum album, Calcare
a carbonica, Convallaria majalis, Crotalus horridus," LIQUID ORAL 20110809
UNAPPROVED HOMEOPATHIC Apotheca Company "AMERICAN GINSENG; ARSEN
IC TRIOXIDE; CONVALLARIA MAJALIS; CORTISONE ACETATE; CROTALUS HORRIDUS HORRIDUS
VENOM; EPINEPHRINE; HOPS; IRON; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORI
C ACID; PHOSPHORUS; SELENIUM; SEPIA OFFICINALIS JUICE; STRYCHNOS NUX-VOMICA SEED
; SUS SCROFA THYROID" 3; 12; 12; 6; 12; 6; 3; 12; 12; 30; 12; 8; 12; 12; 6
/mL
57520-0776_ac497c5c-cd51-4ad6-a587-c73b046715d9 57520-0776 HUMAN OTC DRUG
Arthritis Care "Colchicum autumnale, Propolis, Kalmia latifolia, Bryoni
a, Causticum, Kali carbonicum, Ledum palustre, Rhododendron chrysanthum, Rhus to
xicodendron, Thuja occidentalis," GEL TOPICAL 20110926
UNAPPROVED HOMEOPATHIC Apotheca Company BRYONIA ALBA ROOT; CAUST
ICUM; COLCHICUM AUTUMNALE BULB; KALMIA LATIFOLIA LEAF; LEDUM PALUSTRE TWIG; POTA
SSIUM CARBONATE; PROPOLIS WAX; RHODODENDRON AUREUM LEAF; THUJA OCCIDENTALIS LEAF
Y TWIG; TOXICODENDRON PUBESCENS LEAF 12; 12; 6; 6; 12; 12; 6; 12; 12; 12
[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g;
[hp_X]/g; [hp_X]/g
57520-0777_fb927e05-fec0-4e00-878f-a3f8a215deaf 57520-0777 HUMAN OTC DRUG
Itchy Gone "Apis mellifica, Belladonna, Calcarea carbonica, Medusa,
Mezereum, Rhus toxicodendron, Astacus fluviatilis, Chloralum," GEL TOPICAL
"APIS MELLIFERA; ASTACUS ASTACUS; ATROPA BELLADONNA; CHLORAL HYDRATE; DAPHNE MEZ
EREUM BARK; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYSALIA PHYSALIS; TOXICODEND
RON PUBESCENS LEAF" 12; 15; 12; 15; 12; 12; 12; 12 [hp_X]/g; [hp_X]/g; [hp_
X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g
57520-0778_cec776b6-2985-4543-85f3-df3abb402851 57520-0778 HUMAN OTC DRUG
Hemorrhoid Care "Hamamelis virginiana, Aesculus hippocastanum, Aloe soco
trina, Paeonia officinalis, Ignatia amara, Lycopodium clavatum, Nitricum acidum,
Nux vomica, Phosphorus, Podophyllum peltatum, Pulsatilla, Sulphu" GEL
ALOE; CHELIDONIUM MAJUS; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HORSE CHESTNU
T; KRAMERIA LAPPACEA ROOT; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; PAEONIA OFFIC
INALIS ROOT; PHOSPHORUS; PODOPHYLLUM; PULSATILLA VULGARIS; STRYCHNOS IGNATII SEE
D; STRYCHNOS NUX-VOMICA SEED; SULFUR 6; 30; 1; 1; 12; 12; 12; 6; 12; 12; 12;
12; 12; 12 [hp_X]/g; [hp_C]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_
X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g
57520-0781_e7e21c86-8c41-4ddd-b05b-c6f355cf1f71 57520-0781 HUMAN OTC DRUG
Bruises Gone "Calendula officinalis, Arnica montana, Hypericum perfor
atum, Symphytum officinale, Bellis perennis, Ledum palustre, Sulphuricum acidum,
Calcarea fluorica, Ferrum phosphoricum, Rhus toxicodendron, Ruta" GEL
ARNICA MONTANA; BELLIS PERENNIS; CALCIUM FLUORIDE; CALENDULA OFFICINALIS FLOWERI
NG TOP; COMFREY ROOT; FERRUM PHOSPHORICUM; HYPERICUM PERFORATUM; LEDUM PALUSTRE
TWIG; RUTA GRAVEOLENS FLOWERING TOP; SODIUM SULFATE; SULFURIC ACID; TOXICODENDRO
N PUBESCENS LEAF 1; 12; 30; 1; 3; 30; 1; 12; 30; 30; 12; 30 [hp_X]/g
; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g
; [hp_C]/g; [hp_X]/g; [hp_X]/g
57520-0787_205cd186-8a66-457d-86a1-10061666b427 57520-0787 HUMAN OTC DRUG
Biological Complex II "Anthracinum," LIQUID ORAL 20110826
UNAPPROVED HOMEOPATHIC Apotheca Company BACILLUS ANTHRACIS IMMUN
OSERUM RABBIT 30 [hp_C]/mL
57520-0788_1b5364bf-6c67-4630-b24e-c650feabc014 57520-0788 HUMAN OTC DRUG
Headache "Cimicifuga racemosa, Gelsemium sempervirens, Rhus toxic
odendron," LIQUID ORAL 20110817 UNAPPROVED HOMEOPATHIC
Apotheca Company BLACK COHOSH; GELSEMIUM SEMPERVIRENS ROOT; TOXICODENDRON
PUBESCENS LEAF 2; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0789_e076a2bb-6ba9-44da-9a31-ead3d3236c3f 57520-0789 HUMAN OTC DRUG
Liver Drainage "Berberis vulgaris, Chelidonium majus, Carduus marianus,
Schisandra chinensis, Taraxacum officinale, Picrorhiza scrophulariiflora, Rapha
nus sativus, Viscum album Chromium gluconate, Cobaltum gluconate," LIQUID
"BERBERIS VULGARIS ROOT BARK; CHELIDONIUM MAJUS; CHROMIUM GLUCONATE; CICHORIUM I
NTYBUS FLOWER; COBALTOUS GLUCONATE; COPPER GLUCONATE; LACTIC ACID, L-; MAGNESIUM
GLUCONATE; NEOPICRORHIZA SCROPHULARIIFLORA ROOT; PHENOL; PORK LIVER; PTELEA TRI
FOLIATA BARK; RADISH; SCHISANDRA CHINENSIS FRUIT; SILYBUM MARIANUM SEED; SODIUM
SULFATE; STRYCHNOS NUX-VOMICA SEED; SULFUR IODIDE; SUS SCROFA GALLBLADDER; SUS S
CROFA PANCREAS; TARAXACUM OFFICINALE; VANADIUM; VERBENA OFFICINALIS FLOWERING TO
P; VISCUM ALBUM FRUITING TOP" 1; 1; 6; 8; 6; 6; 6; 6; 3; 8; 8; 6; 3; 2; 2; 6;
8; 6; 8; 8; 2; 8; 8; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [
57520-0790_3239be08-9091-44c6-9a49-c45deb8abd1a 57520-0790 HUMAN OTC DRUG
Tryptophan "Tryptophan," LIQUID ORAL 20110817
UNAPPROVED HOMEOPATHIC Apotheca Company TRYPTOPHAN 6
[hp_X]/mL
57520-0795_4c23d753-9e06-4ffb-ac49-6acf5d90eea7 57520-0795 HUMAN OTC DRUG
Caffeic Acid "Caffeic acid," LIQUID ORAL 20110829
UNAPPROVED HOMEOPATHIC Apotheca Company CAFFEIC ACID 6
[hp_X]/mL
57520-0797_81766789-b681-40a3-a198-04170ebace55 57520-0797 HUMAN OTC DRUG
Coniferyl Alcohol "Coniferyl alcohol," LIQUID ORAL 20110824
UNAPPROVED HOMEOPATHIC Apotheca Company CONIFERYL ALCOHOL
6 [hp_X]/mL
57520-0801_21df286b-cb44-47d4-a788-b38439183566 57520-0801 HUMAN OTC DRUG
FNG "Berberis vulgaris, Cochlearia armoracia, Echinacea, Hydrastis c
anadensis, Lomatium dissectum, Myrrha, Tabebuia impetiginosa, Propolis, Glandula
suprarenalis suis, Thymus suis, Ferrum metallicum," LIQUID ORAL 20110831
UNAPPROVED HOMEOPATHIC Apotheca Company ALTERNARIA ALTERNATA; AS
PERGILLUS NIGER; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; BERBERIS VULGARIS ROOT
BARK; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; ECHINACEA; GOLDENSEAL; HORSERADISH
; IRIDIUM; IRON; LOMATIUM DISSECTUM ROOT; LYCOPODIUM CLAVATUM SPORE; MUCOR RACEM
OSUS; MYRRH; PHOSPHORIC ACID; PROPOLIS WAX; PULSATILLA VULGARIS; RHIZOPUS STOLON
IFER; SACCHAROMYCES CEREVISIAE; SELENIUM; STACHYBOTRYS CHARTARUM; SUS SCROFA ADR
ENAL GLAND; SUS SCROFA THYMUS; TABEBUIA IMPETIGINOSA BARK; ZINC 12; 12; 12; 3; 1
2; 12; 3; 3; 3; 12; 12; 3; 12; 12; 3; 12; 6; 12; 12; 12; 12; 12; 8; 8; 3; 12
57520-0802_e57c0bfa-a754-4889-ab04-1d78d00ac2c3 57520-0802 HUMAN OTC DRUG
Formaldehyde "Formalinum," LIQUID ORAL 20110822
UNAPPROVED HOMEOPATHIC Apotheca Company FORMALDEHYDE 6
[hp_X]/mL
57520-0804_7949200b-8690-4a22-9308-f72e47419a61 57520-0804 HUMAN OTC DRUG
Norepinephrine "Norepinephrine," LIQUID ORAL 20110822
UNAPPROVED HOMEOPATHIC Apotheca Company NOREPINEPHRINE 6
[hp_X]/mL
57520-0805_2df7d6c8-cf6f-4389-ab98-26715ac02a69 57520-0805 HUMAN OTC DRUG
Upper Respiratory Staph Strep Combo "Staphylococcus aureus, Klebsiel
la pneumoniae, Haemophilus influenzae," LIQUID ORAL 20110829
UNAPPROVED HOMEOPATHIC Apotheca Company HAEMOPHILUS INFLUENZAE;
KLEBSIELLA PNEUMONIAE; STAPHYLOCOCCUS AUREUS 12; 15; 15 [hp_C]/mL; [hp_X
]/mL; [hp_X]/mL
57520-0833_d3c13cee-444f-47d9-99f2-4352ee817120 57520-0833 HUMAN OTC DRUG
Perfect Sleep "Adenosine triphosphate, Coenzyme A, Coenzyme Q10, Pinea
l Gland Suis, Sarcolacticum acidum, Melatonin, Pyrrole, Tryptophan, Arsenicum al
bum, Avena sativa," LIQUID ORAL 20110826 UNAPPROVED HOMEO
PATHIC Apotheca Company "ADENOSINE TRIPHOSPHATE; ARABICA COFFEE
BEAN; ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; COENZYME A; LACTIC ACID, L-;
MATRICARIA RECUTITA; MELATONIN; MERCURIC CHLORIDE; PASSIFLORA INCARNATA FLOWER;
PYRROLE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SHIGELLA DYSE
NTERIAE; SILICON DIOXIDE; SUS SCROFA PINEAL GLAND; TRYPTOPHAN; UBIDECARENONE; ZI
NC VALERATE DIHYDRATE" 8; 10; 10; 10; 8; 8; 10; 8; 10; 10; 8; 30; 30; 10; 8; 8;
/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL
57520-0835_78aae604-0cd6-4554-bcd9-0b3af9905696 57520-0835 HUMAN OTC DRUG
Acetylcholine Chloride Acetylcholine chloride LIQUID ORAL 20110909
UNAPPROVED HOMEOPATHIC Apotheca Company ACETYLCHOLINE CHLORIDE
6 [hp_X]/mL
57520-0836_51ed9468-45d9-4606-86ab-0b39d8fa5b31 57520-0836 HUMAN OTC DRUG
Aspartame MSG Detox "Chelidonium majus, Phytolacca decandra, Arnica
Montana, Nitricum acidum, Nux vomica, Phosphoricum acidum, Aspartic acid, Diketo
piperazine, Dopamine, Formalinum," LIQUID ORAL 20110824
UNAPPROVED HOMEOPATHIC Apotheca Company "2,5-PIPERAZINEDIONE; AR
NICA MONTANA; ASPARTIC ACID; CHELIDONIUM MAJUS; DOPAMINE; FORMALDEHYDE; FORMIC A
CID; METHYL ALCOHOL; MONOSODIUM GLUTAMATE; NITRIC ACID; PHENYLALANINE; PHOSPHORI
C ACID; PHYTOLACCA AMERICANA ROOT; STRYCHNOS NUX-VOMICA SEED" 30; 6; 30; 3; 30
57520-0838_bc36e5be-ec18-4bc5-b51f-afbb3ce70401 57520-0838 HUMAN OTC DRUG
Sulphur Remedy "Sulphur, Asclepias tuberosa, Bryonia, Dulcamara,"
Company ASCLEPIAS TUBEROSA FLOWERING TOP; BRYONIA ALBA ROOT; SOLANUM DUL
CAMARA FLOWER; SULFUR 6; 10; 10; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/
mL
57520-0840_f463affd-1363-4fe2-b2ab-c69397dcb150 57520-0840 HUMAN OTC DRUG
Ver "Artemisia Vulgaris, Filix Mas, Cina, Melilotus Officinalis,"
Company "ARTEMISIA CINA FLOWER; ARTEMISIA VULGARIS ROOT; ASCARIS LUMBRIC
OIDES; BRUGIA MALAYI; CRYPTOSPORIDIUM PARVUM; DRYOPTERIS FILIX-MAS ROOT; ENTEROB
IUS VERMICULARIS; GIARDIA LAMBLIA; GRAPHITE; IODINE; MELILOTUS OFFICINALIS POLLE
N; MERCURIC CHLORIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; QUASSIA AMARA WOOD;
SCHOENOCAULON OFFICINALE SEED; SILICON DIOXIDE; SPIGELIA ANTHELMIA; TAENIA SAGI
NATA; TAENIA SOLIUM; TEUCRIUM MARUM; THYMUS SERPYLLUM; TRICHINELLA SPIRALIS; TRI
CHOMONAS VAGINALIS" 3; 2; 15; 39; 20; 2; 33; 18; 12; 12; 3; 12; 12; 3; 12; 8
; 3; 20; 12; 3; 3; 15; 13 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_
C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/
mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL;
[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL
57520-0846_8ba6863a-3c60-4b4a-ac63-c54c519bf49b 57520-0846 HUMAN OTC DRUG
Bio Wild Rose "Wild rose," LIQUID ORAL 20111104
UNAPPROVED HOMEOPATHIC Apotheca Company ROSA CANINA FLOWER
6 [hp_X]/mL
57520-0870_482ee5fb-cdfb-46c7-b431-a1e1e58d21f0 57520-0870 HUMAN OTC DRUG
Infectistat "Baptisia tinctoria, Echinacea, Hydrastis canadensis,"
Company "ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BAPTISI
A TINCTORIA ROOT; BRYONIA ALBA ROOT; CAUSTICUM; COMFREY ROOT; ECHINACEA, UNSPECI
FIED; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERRUM PHOSPHORICUM; GELSEMIUM SEMPE
RVIRENS ROOT; GOLDENSEAL; HYPERICUM PERFORATUM; LACHESIS MUTA VENOM; LOBELIA INF
LATA; LOMATIUM DISSECTUM ROOT; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; POTASSIUM
CARBONATE; PULSATILLA VULGARIS; RANCID BEEF; SILICON DIOXIDE; SODIUM SULFATE; SU
LFUR; SUS SCROFA LUNG; TOXICODENDRON PUBESCENS LEAF" 12; 12; 12; 3; 12; 12; 3
; 3; 12; 12; 12; 3; 12; 12; 3; 3; 12; 3; 12; 12; 30; 12; 12; 12; 6; 12 [hp_X]/m
57520-0888_fcda645f-c763-4326-8dff-3bfc3603f22d 57520-0888 HUMAN OTC DRUG
Enviroforce "Hydrastis canadensis, Phytolacca decandra, Sarsaparilla
, Xanthoxylum fraxineum, Aurum metallicum, Carbo animalis, Causticum, Iodium Sul
phur, Thuja occidentalis," LIQUID ORAL 20111108 UNAPPROV
ED HOMEOPATHIC Apotheca Company CARBO ANIMALIS; CAUSTICUM; GOLD;
GOLDENSEAL; IODINE; PHYTOLACCA AMERICANA ROOT; SMILAX REGELII ROOT; SULFUR; THU
JA OCCIDENTALIS LEAFY TWIG; ZANTHOXYLUM AMERICANUM BARK 12; 12; 12; 3; 12; 3; 3;
57520-0900_4c548e3c-f209-44dd-82e9-f25ee6b20dd9 57520-0900 HUMAN OTC DRUG
Biting Insects Antigens "Apis mellifica, Hypericum perforatum, Ledum pal
ustre, Cimex lectularius, Formica rufa, Pulex irritans, Vespa crabo," LIQUID
APIS MELLIFERA; CIMEX LECTULARIUS; FORMICA RUFA; HYPERICUM PERFORATUM; LEDUM PAL
USTRE TWIG; PULEX IRRITANS; VESPA CRABRO 12; 15; 15; 12; 12; 15; 15
57520-0908_9a735933-1eaa-4a78-81f8-22f4fcac3c37 57520-0908 HUMAN OTC DRUG
Detox II "Solidago virgaurea, Baptisia tinctoria, Berberis vulgaris, Equi
setum hyemale, Argentum nitricum, Cantharis, Capsicum annuum, Cuprum sulphuricum
, Orthosiphon stamineus, Pareira brava, Sarsaparilla, Ter" LIQUID ORAL
AGATHOSMA BETULINA LEAF; APIS MELLIFERA VENOM; BAPTISIA TINCTORIA; BERBERIS VULG
ARIS ROOT BARK; CALCIUM SULFIDE; CAPSICUM; CHONDRODENDRON TOMENTOSUM ROOT; CLERO
DENDRANTHUS SPICATUS LEAF; CUPRIC SULFATE; EQUISETUM HYEMALE; ESCHERICHIA COLI;
GLYOXAL TRIMER DIHYDRATE; LYTTA VESICATORIA; MERCURIC CHLORIDE; QUERCETIN; SHIGE
LLA DYSENTERIAE; SILVER NITRATE; SMILAX REGELII ROOT; SODIUM PYRUVATE; SOLIDAGO
VIRGAUREA FLOWERING TOP; SUS SCROFA RENAL PELVIS; SUS SCROFA URETER; SUS SCROFA
URETHRA; SUS SCROFA URINARY BLADDER; TURPENTINE 8; 8; 4; 4; 10; 6; 6; 6; 6; 4; 1
5; 10; 6; 8; 10; 30; 6; 6; 10; 3; 8; 8; 8; 8; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL;
p_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X
L
57520-0917_0bd4934a-4d0f-4a15-bf2a-c6273fe24294 57520-0917 HUMAN OTC DRUG
Stay Well "Echinacea purpurea, Argentum nitricum, Baptisia tinctor
ia, Galium aparine, Pulsatilla, Thuja occidentalis, Phosphorus, Thymus serpyllum
, Echinacea, Sulphur," LIQUID ORAL 20111114 UNAPPROVED HOMEO
PATHIC Apotheca Company "BAPTISIA TINCTORIA ROOT; ECHINACEA PURP
UREA; ECHINACEA, UNSPECIFIED; GALIUM APARINE; PHOSPHORUS; PULSATILLA VULGARIS; S
ILVER NITRATE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; THYMUS SERPYLLUM" 6; 3; 6;
57520-0918_8d6d09a2-7d0f-465a-b394-58ebe01f0df2 57520-0918 HUMAN OTC DRUG
Trauma Drama "Belladonna, Calendula officinalis, Bellis perennis, Hyp
ericum perforatum, Arnica montana, Mercuris solubilis, Symphytum officinale, Rhu
s toxicodendron, Ruta graveolens" LIQUID ORAL 20111111
UNAPPROVED HOMEOPATHIC Apotheca Company ARNICA MONTANA ROOT; ATR
OPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY RO
OT; HYPERICUM PERFORATUM; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS; RUTA GRAVEOL
ENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF 6; 6; 6; 6; 30; 6; 6; 12; 6; 6
_X]/mL; [hp_C]/mL; [hp_C]/mL
57520-0919_fd970425-7e31-4428-a428-9456d47f3675 57520-0919 HUMAN OTC DRUG
Thyroid Rhythm "Adrenalinum, Calcarea iodata, Kali iodatum, Pituitary b
ovine, Spleen bovine, Thymus bovine, Thyrodinum, Spongia tosta, Fucus vesiculosu
s, Calcarea fluorica, Ferrum iodatum, Iodium Calcarea carbonica," LIQUID
"BOS TAURUS PITUITARY GLAND; BOS TAURUS SPLEEN; BOS TAURUS THYMUS; CALCIUM FLUOR
IDE; CALCIUM IODIDE; EPINEPHRINE; FERROUS IODIDE; FUCUS VESICULOSUS; IODINE; OYS
TER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM IODIDE; SODIUM CHLORIDE; SPONGIA O
FFICINALIS SKELETON, ROASTED; THYROID, BOVINE" 6; 6; 6; 8; 6; 6; 8; 6; 9; 30; 6
hp_X]/mL
57520-0920_d9f9a9c8-0aa1-4a37-b3f9-fc6474ec120f 57520-0920 HUMAN OTC DRUG
Influenza Remedy "Eucalyptus globulus, Ipecacuanha, Aconitum nape
llus," LIQUID ORAL 20111025 UNAPPROVED HOMEOPATHIC
Apotheca Company ACONITUM NAPELLUS; EUCALYPTUS GLOBULUS LEAF; IPECAC
3; 2; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0922_fd54ae81-aedb-43bf-9341-1f1a944084a8 57520-0922 HUMAN OTC DRUG
Phloridzin "Phloridzinum," LIQUID ORAL 20110929
UNAPPROVED HOMEOPATHIC Apotheca Company PHLORIZIN 6
[hp_X]/mL
57520-0923_e4adbd51-6b8c-4405-9eb2-8c7d6305071b 57520-0923 HUMAN OTC DRUG
Stomach Spleen Meridian Opener "Arsenicum album, Calcarea carbonica, Ca
rduus marianus, Ceanothus americanus, Cinchona officinalis, Digitalis purpurea,
Ignatia amara, Kali bichromicum, Lycopodium clavatum," LIQUID ORAL 20110930
UNAPPROVED HOMEOPATHIC Apotheca Company "ARSENIC TRIOXIDE; CEANO
THUS AMERICANUS LEAF; CINCHONA OFFICINALIS BARK; DIGITALIS; LEAD; LYCOPODIUM CLA
VATUM SPORE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; POTASSIUM DICHRO
MATE; PULSATILLA VULGARIS; RANUNCULUS BULBOSUS; SILYBUM MARIANUM SEED; STRYCHNOS
IGNATII SEED; VERATRUM VIRIDE ROOT" 30; 30; 30; 30; 30; 30; 30; 30; 30; 30;
30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL
; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [
hp_C]/mL
57520-0925_825c6ade-d54a-494e-a305-5f32a7b791e4 57520-0925 HUMAN OTC DRUG
Arthritis Joints "Gnaphalium polycephalum, Berberis vulgaris, Cim
icifuga racemosa, Cinchona officinalis, Colocynthis, Ledum palustre, Ranunculus
bulbosus, Aesculus hippocastanum, Borax, Cuprum aceticum, Kali carbonicum"
Company "AMMONIUM CHLORIDE; BERBERIS VULGARIS ROOT BARK; BLACK COHOSH; C
INCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; CLAVICEPS PURPUREA S
CLEROTIUM; CUPRIC ACETATE; HORSE CHESTNUT; LEDUM PALUSTRE TWIG; MERCURIC OXIDE,
YELLOW; PALLADIUM; POTASSIUM CARBONATE; PSEUDOGNAPHALIUM OBTUSIFOLIUM; PULSATILL
A VULGARIS; RANUNCULUS BULBOSUS; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SILVE
R; SODIUM BORATE; SULFUR; SUS SCROFA ADRENAL GLAND; SUS SCROFA BONE MARROW; SUS
SCROFA CARTILAGE; SUS SCROFA INTERVERTEBRAL DISC; TRIBASIC CALCIUM PHOSPHATE; TR
INITROPHENOL; ZINC" 8; 4; 4; 4; 4; 6; 6; 6; 4; 10; 12; 6; 3; 6; 4; 10; 8; 10
p_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X
]/mL; [hp_X]/mL
57520-0927_bfeb9d83-2816-4d51-a0f4-ad09ab4e6e58 57520-0927 HUMAN OTC DRUG
Eye Sarcode "Eye suis," LIQUID ORAL 20111024
UNAPPROVED HOMEOPATHIC Apotheca Company SUS SCROFA EYE 30
[hp_C]/mL
57520-0929_edd187ce-ee6f-4600-b44d-73eeb605a14e 57520-0929 HUMAN OTC DRUG
Pre-Dental Visit "Juglans regia, Myosotis arvensis, Scrophularia
nodosa, Teucrium scroodonia, Veronica officinalis, Equisetum arvense, Fumaria of
ficinalis, Geranium robertianum, Nasturtium aquaticum, Natrum sulphuricum"
Company "ARANEUS DIADEMATUS; CLEMATIS VITALBA PRE-FLOWERING TOP; EQUISET
UM ARVENSE TOP; FERROUS IODIDE; FUMARIA OFFICINALIS FLOWERING TOP; GENTIANA LUTE
A ROOT; GERANIUM ROBERTIANUM; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDUL
IFERA FLOWER; JUGLANS REGIA LEAF; MYOSOTIS ARVENSIS; ORNITHOGALUM UMBELLATUM; PI
NUS SYLVESTRIS FLOWERING TOP; PRUNUS CERASIFERA FLOWER; RORIPPA NASTURTIUM-AQUAT
ICUM; SCROPHULARIA NODOSA; SMILAX REGELII ROOT; SODIUM SULFATE; SUS SCROFA LYMPH
; TEUCRIUM SCORODONIA FLOWERING TOP; THYROID, PORCINE; TRIBASIC CALCIUM PHOSPHAT
E; VERONICA OFFICINALIS FLOWERING TOP" 12; 8; 4; 12; 4; 5; 4; 8; 8; 3; 3; 8; 4;
57520-0931_e66804bd-f3c6-49cf-8f44-d345b2b98260 57520-0931 HUMAN OTC DRUG
Addiclenz "Beta vulgaris, Boldo, Chelidonium majus, Petroselinum s
ativum, Taraxacum officinale, Arsenicum album, Belladonna, Cobaltum metallicum,
Cuprum metallicum, Iodium, Lycopodium clavatum, Phosphoricum acidum, Selenium me
tallicum, Zincum metallicum," LIQUID ORAL 20111104 20170419
UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; ASPART
AME; ATROPA BELLADONNA; BENZALKONIUM CHLORIDE; BETA VULGARIS; CHELIDONIUM MAJUS;
COBALT; COPPER; FORMALDEHYDE; IODINE; LYCOPODIUM CLAVATUM SPORE; METHYLENE CHLO
RIDE; METHYLPARABEN; PETROSELINUM CRISPUM; PEUMUS BOLDUS LEAF; PHOSPHORIC ACID;
PROPYLPARABEN; SELENIUM; SODIUM BENZOATE; SODIUM CITRATE; TARAXACUM OFFICINALE;
TITANIUM DIOXIDE; ZINC; ZINC OXIDE 12; 30; 12; 30; 3; 3; 12; 12; 30; 12; 12
; 30; 30; 3; 3; 12; 30; 12; 30; 30; 3; 30; 12; 30 [hp_X]/mL; [hp_X]/mL; [h
57520-0932_9f87e452-2cff-4336-a291-ae7f533fde14 57520-0932 HUMAN OTC DRUG
Bronchial Cough "Coccus cacti, Drosera, Scilla maritima, Arsenicum iodat
um, Causticum, Cuprum aceticum, Carbo vegetabilis, Kali Carbonicum, Lachesis mut
us," LIQUID ORAL 20111028 UNAPPROVED HOMEOPATHIC
Apotheca Company ACTIVATED CHARCOAL; ARSENIC TRIIODIDE; CAUSTICUM; CUPRIC
ACETATE; DRIMIA MARITIMA BULB; DROSERA ROTUNDIFOLIA; LACHESIS MUTA VENOM; POTAS
SIUM CARBONATE; PROTORTONIA CACTI 12; 6; 6; 6; 4; 4; 12; 12; 4 [hp_X]/m
[hp_X]/mL
57520-0934_44d92995-4a29-4eef-8817-f04cf56454a9 57520-0934 HUMAN OTC DRUG
Joint Pain "Arnica montana, Bryonia, Causticum, Rhus toxicodendron,
Ferrum phosphoricum," LIQUID ORAL 20111102 UNAPPROVED HOMEO
PATHIC Apotheca Company ARNICA MONTANA; BRYONIA ALBA ROOT; CAUST
ICUM; FERRUM PHOSPHORICUM; TOXICODENDRON PUBESCENS LEAF 4; 4; 4; 8; 6 [hp_X]/m
57520-0936_314ac7f9-9f44-41e7-a8a2-0b3722f032ea 57520-0936 HUMAN OTC DRUG
Taurine "Taurine," LIQUID ORAL 20111102 UNAPPROV
ED HOMEOPATHIC Apotheca Company TAURINE 6 [hp_X]/mL
57520-0937_3eaaa5f3-040d-46e8-8823-fd2f76ddeef9 57520-0937 HUMAN OTC DRUG
Bio Crab Apple Crab Apple LIQUID ORAL 20111104
UNAPPROVED HOMEOPATHIC Apotheca Company MALUS SYLVESTRIS FLOWER
6 [hp_X]/mL
57520-0938_730e416d-40d2-4327-8424-8a1ff8ea6506 57520-0938 HUMAN OTC DRUG
Bladder Kidney Meridian Opener "Apis mellifica, Argentum nitricum, Berberis vul
garis, Cantharis, Equisetum arvense, Kali bichromicum, Lycopodium clavatum, Merc
urius solubilis, Natrum muriaticum, Phosphorus, Rhus toxicodendron, Sepia"
Company APIS MELLIFERA; BERBERIS VULGARIS ROOT BARK; EQUISETUM ARVENSE T
OP; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; MERCURIUS SOLUBILIS; PHOSPHORU
S; POTASSIUM DICHROMATE; SEPIA OFFICINALIS JUICE; SILVER NITRATE; SODIUM CHLORID
E; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF; TURPENTINE
30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [h
]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL
57520-0939_69590a5a-5dfc-4dac-912c-f341fc73f2e3 57520-0939 HUMAN OTC DRUG
Focus RxS "Alpha-ketoglutaricum acidum, ATP, Formicum acidum, Mali
cum acidum, Sarcolacticum acidum, Dulcamara, Hyoscyamus niger, Phosphorus, Sabin
a, Acetylcholine chlorice, Adrrenalinum, Dopamine, Gaba, Norepine" LIQUID
".ALPHA.-KETOGLUTARIC ACID; .GAMMA.-AMINOBUTYRIC ACID; ACETYLCHOLINE CHLORIDE; A
DENOSINE CYCLIC 3',5'-PHOSPHATE; ADENOSINE TRIPHOSPHATE; ARSENIC TRIOXIDE; ATROP
A BELLADONNA; DOPAMINE; EPINEPHRINE; FORMIC ACID; HYOSCYAMUS NIGER; JUNIPERUS SA
BINA LEAFY TWIG; LACTIC ACID, L-; LYCOSA TARANTULA; MALIC ACID; NOREPINEPHRINE;
OCTOPAMINE; PHENETHYLAMINE; PHOSPHORUS; PORK BRAIN; SEROTONIN; SHIGELLA DYSENTER
IAE; SILICON DIOXIDE; SOLANUM DULCAMARA FLOWER; STRYCHNOS NUX-VOMICA SEED; SUS S
CROFA BRAINSTEM; SUS SCROFA CEREBRUM; SUS SCROFA DIENCEPHALON; SUS SCROFA PINEAL
GLAND; SUS SCROFA THALAMUS LATERAL GENICULATE NUCLEUS; TAURINE; TYRAMINE; VALER
IAN; VERATRUM ALBUM ROOT" 6; 6; 6; 8; 6; 30; 30; 6; 6; 6; 6; 6; 6; 30; 6;
6; 6; 6; 6; 8; 6; 30; 8; 6; 30; 8; 8; 8; 8; 8; 6; 6; 30; 30 [hp_X]/mL; [hp_X
]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/m
L; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL;
[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp
_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]
/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL
57520-0940_4d57343c-7d19-4ed3-8cdc-78ccf1081ec2 57520-0940 HUMAN OTC DRUG
Healing Support "Betula pendula, cortex, Caltha palustris, Galium aparin
e, Sedum acre, Thuja occidentalis, Urtica urens, Clematis erecta, Hedera helix,
Juniperus communis, Ononis spinosa, Quillaja saponaria, Semperviv" LIQUID
"APIS MELLIFERA; BETULA PENDULA BARK; CALCIUM FLUORIDE; CALTHA PALUSTRIS; CLEMAT
IS RECTA FLOWERING TOP; ECHINACEA, UNSPECIFIED; GALIUM APARINE; HEDERA HELIX FLO
WERING TWIG; JUNIPER; NITRIC ACID; ONONIS REPENS WHOLE; PHOSPHORUS; QUILLAJA SAP
ONARIA BARK; RANCID BEEF; SEDUM ACRE; SEMPERVIVUM TECTORUM LEAF; SILVER; THUJA O
CCIDENTALIS LEAFY TWIG; URTICA URENS" 12; 2; 8; 3; 4; 5; 3; 4; 4; 6; 4; 8; 4;
57520-0942_58dd0037-1bc9-4420-941b-95d9c544d5c8 57520-0942 HUMAN OTC DRUG
Petrochemical Detox "Chelidonium majus, Symphytum officinale, Taraxa
cum officinale, Trifolium pratense, Acetone, Sodium triphosphate, Propylene glyc
ol, Sodium benzene sulfonate, Ammonium muriaticum, Sodium lauryl sulfate,"
Company ACETONE; AMMONIUM CHLORIDE; ARSENIC TRIOXIDE; BENZENESULFONIC AC
ID; CADMIUM SULFIDE; CHELIDONIUM MAJUS; COMFREY ROOT; GELSEMIUM SEMPERVIRENS ROO
T; IRIDIUM; KEROSENE; LATRODECTUS MACTANS; LYCOPODIUM CLAVATUM SPORE; MERCURIUS
SOLUBILIS; NITRIC ACID; PHOSPHORIC ACID; PLATINUM; PROPYLENE GLYCOL; SODIUM LAUR
YL SULFATE; SODIUM TRIPOLYPHOSPHATE; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICI
NALE; TRIFOLIUM PRATENSE FLOWER; TURPENTINE 9; 9; 12; 9; 12; 3; 3; 12; 12; 1
57520-0949_b5cde4ba-64f4-4284-b14b-028d6fe792ee 57520-0949 HUMAN OTC DRUG
Varico HP "Calcarea Fluorica, Carbo Vegetabilis, Hamamelis Virginiana, Lac
hesis Mutus, Lycopodium Clavatum, Pulsatilla, Secale Cornutum, Staphysagria, Zin
cum Metallicum" LIQUID ORAL 20111107 UNAPPROVED HOMEOPATHIC
Apotheca Company ACTIVATED CHARCOAL; CALCIUM FLUORIDE; CLAVICEPS PURPUREA
SCLEROTIUM; DELPHINIUM STAPHISAGRIA SEED; HAMAMELIS VIRGINIANA ROOT BARK/STEM B
ARK; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; ZINC
30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/
57520-0951_4a3c0be7-b711-44d3-ae8e-6d936fa51e45 57520-0951 HUMAN OTC DRUG
Gyno Complex "Viburnum opulus, Magnesia phosphorica, Folliculinum, Pu
lsatilla, Borax, Mercurius solubilis, Nitricum acidum, Silicea, Thuja occidental
is," LIQUID ORAL 20111116 UNAPPROVED HOMEOPATHIC
Apotheca Company "ESTRONE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MERCU
RIUS SOLUBILIS; NITRIC ACID; PULSATILLA VULGARIS; SILICON DIOXIDE; SODIUM BORATE
; THUJA OCCIDENTALIS LEAFY TWIG; VIBURNUM OPULUS BARK" 12; 8; 30; 30; 12; 30; 3
; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0954_7dd4de79-5475-440b-b78e-4514f95e7a27 57520-0954 HUMAN OTC DRUG
Seafood Antigens "Codfish, Flounder, Halibut, Mackerel, Tuna, Cla
m, Crab, Oyster, Scallops, Shrimp, Belladonna, Carbo animalis, Colocynthis, Kali
Carbonicum, Lycopodium clavatum, Pulsatilla," LIQUID ORAL 20111117
UNAPPROVED HOMEOPATHIC Apotheca Company "ATLANTIC HALIBUT; ATROP
A BELLADONNA; BLUE CRAB; CARBO ANIMALIS; CITRULLUS COLOCYNTHIS FRUIT PULP; COD,
UNSPECIFIED; EDIBLE OYSTER; EUROPEAN FLOUNDER; LYCOPODIUM CLAVATUM SPORE; POTASS
IUM CARBONATE; PULSATILLA VULGARIS; QUAHOG, UNSPECIFIED; SCOMBEROMORUS CAVALLA W
HOLE; SEA SCALLOP; SHRIMP, UNSPECIFIED; TUNA, UNSPECIFIED" 9; 12; 9; 12; 12
; 9; 9; 9; 12; 12; 12; 9; 9; 9; 9; 9 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/
57520-0955_a9321767-d9f4-4625-88a8-fd9dcf8b04ee 57520-0955 HUMAN OTC DRUG
Bio Heather "Heather," LIQUID ORAL 20111114
UNAPPROVED HOMEOPATHIC Apotheca Company CALLUNA VULGARIS FLOWERI
NG TOP 6 [hp_X]/mL
57520-0957_60c0e38b-269d-431d-b706-9dd0a70cba91 57520-0957 HUMAN OTC DRUG
Psoriaforce "Baptisia tinctoria, Berberis vulgaris, Echinacea, Glycy
rrhiza glabra, Hydrastis canadensis, Lappa major, Phytolacca decandra, Rhamnus f
rangula Lappa major, Phytolacca decandra, Rhamnus frangula, Rhamn" LIQUID
"ARCTIUM LAPPA ROOT; ARSENIC TRIIODIDE; BAPTISIA TINCTORIA ROOT; BERBERIS VULGAR
IS ROOT BARK; CLEMATIS RECTA FLOWERING TOP; DAPHNE MEZEREUM BARK; ECHINACEA, UNS
PECIFIED; FRANGULA ALNUS BARK; FRANGULA PURSHIANA BARK; GLYCYRRHIZA GLABRA; GOLD
ENSEAL; GRAPHITE; KEROSENE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYTOLACCA AM
ERICANA ROOT; POTASSIUM CHLORIDE; POTASSIUM SULFATE; SEPIA OFFICINALIS JUICE; TR
IFOLIUM PRATENSE FLOWER; ZANTHOXYLUM AMERICANUM BARK" 3; 12; 3; 3; 12; 12; 3;
57520-0958_2d79d577-6bbc-40c0-b4fe-783dfc9399ba 57520-0958 HUMAN OTC DRUG
Kidney Tonic I "Echinacea, Petroselinum sativum, Solidago virgaurea, Uv
a-ursi, Pareira brava, Glutathione, Kidney, Cantharis, Lycopodium clavatum,"
Company "ARCTOSTAPHYLOS UVA-URSI LEAF; CHONDRODENDRON TOMENTOSUM ROOT; E
CHINACEA, UNSPECIFIED; GLUTATHIONE; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA
; PETROSELINUM CRISPUM; PORK KIDNEY; SOLIDAGO VIRGAUREA FLOWERING TOP" 1; 3; 1;
57520-0963_2ae98ffc-bb42-41c5-a155-6fe3b866b264 57520-0963 HUMAN OTC DRUG
Lung Large Intestine Meridian Opener "Aloe socotrina, Alumina, Apis mellifica
, Arsenicum album, Baryta carbonica, Bryonia, Carbo vegetabilis, Chamomilla, Kal
i bichromicum, Phosphorus, Plumbum metallicum, Pyrogenium, Sulphur," LIQUID
ACTIVATED CHARCOAL; ALOE; ALUMINUM OXIDE; APIS MELLIFERA; ARSENIC TRIOXIDE; BARI
UM CARBONATE; BRYONIA ALBA ROOT; LEAD; MATRICARIA RECUTITA; PHOSPHORUS; POTASSIU
M DICHROMATE; RANCID BEEF; SULFUR 30; 30; 30; 30; 30; 30; 30; 30; 30; 30;
; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL
57520-0964_4ac1767c-9e35-4343-a632-320ffbd195ed 57520-0964 HUMAN OTC DRUG
Metab "Ascorbicum acidum, Cysteinum, Manganum gluconate, Alpha-ketoglu
taricum acidum, Fumaricum acidum, Germanium sesquioxide, Iodium, Magnesium metal
licum, Natrum oxalaceticum, Pulsatilla, Thyroidinum suis," LIQUID ORAL
".ALPHA.-KETOGLUTARIC ACID; ASCORBIC ACID; CYSTEINE; FUMARIC ACID; GERMANIUM SES
QUIOXIDE; IODINE; MAGNESIUM; MANGANESE GLUCONATE; PULSATILLA VULGARIS; SODIUM DI
ETHYL OXALACETATE; THYROID, PORCINE; VANADIUM" 12; 6; 9; 12; 12; 12; 12; 10; 12
57520-0966_9f27d903-fc2d-4767-96ad-9864be7279f7 57520-0966 HUMAN OTC DRUG
Cytomegalovirus Remedy Cytomegalovirus LIQUID ORAL 20111122
UNAPPROVED HOMEOPATHIC Apotheca Company HUMAN HERPESVIRUS 5
18 [hp_X]/mL
57520-0968_9de0e652-63cc-4131-958b-cf6f232d0e99 57520-0968 HUMAN OTC DRUG
suis, Pituitaria glandula suis, Thyroidinum suis, Bromium, Calcarea carbonica,
Iodium, Lachesis mutus, Pulsatilla," LIQUID ORAL 20111121
UNAPPROVED HOMEOPATHIC Apotheca Company "BROMINE; FUCUS VESICULO
SUS; IODINE; LACHESIS MUTA VENOM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PULSATI
LLA VULGARIS; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA ADRENAL GLAND; S
US SCROFA PITUITARY GLAND; THYROID, PORCINE" 12; 3; 12; 12; 12; 12; 3; 6; 6;
57520-0969_e564cf7e-22c4-4642-a9f7-93ff250a7696 57520-0969 HUMAN OTC DRUG
E.O.L. "Cholesterinum, Stillingia sylvatica, Zincum gluconicum, Thiamin
um hydrochloricum, 5-hydroxytryptophan, Betain HCL, Biotin, Cholinum CoQ10, Dl-m
ethionine, L-alanine, L-cysteine, L-cystine, L-glutamic a" LIQUID ORAL
"AESCULUS HIPPOCASTANUM FLOWER; ALANINE; AMINOBENZOIC ACID; BETAINE HYDROCHLORID
E; BIOTIN; CHOLECALCIFEROL; CHOLESTEROL; CHOLINE HYDROXIDE; COPPER; CYSTEINE; CY
STINE; GLUTAMIC ACID; ILEX AQUIFOLIUM FLOWERING TOP; LYSINE; MALUS SYLVESTRIS FL
OWER; METHIONINE; OXITRIPTAN; POTASSIUM GLUCONATE; RACEMETHIONINE; SELENIUM; SEL
ENIUM DIOXIDE; SERINE; STILLINGIA SYLVATICA ROOT; SUS SCROFA THYMUS; THIAMINE HY
DROCHLORIDE; THYROID, PORCINE; UBIDECARENONE; ZINC GLUCONATE" 30; 6; 6; 6; 6;
6; 3; 6; 8; 6; 6; 6; 30; 6; 30; 6; 6; 6; 6; 8; 8; 6; 3; 6; 4; 6; 6; 3 [hp_C]/m
[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp
57520-0983_ed45964f-b77e-4436-9b8b-b178660906b0 57520-0983 HUMAN OTC DRUG
Animal Antigens "Arsenicum album, Nux vomica, Phosphorus, Canary feather
s, Cat hair, Cattle epithelia, Chicken feathers, Dog epithelia, Duck feathers, G
erbil epithelia, Goat epithelia, Goose feathers," LIQUID ORAL 20111129
UNAPPROVED HOMEOPATHIC Apotheca Company ANAS PLATYRHYNCHOS FEATH
ER; ANSER ANSER FEATHER; ARSENIC TRIOXIDE; BOS TAURUS SKIN; CANIS LUPUS FAMILIAR
IS SKIN; CAPRA HIRCUS SKIN; CAVIA PORCELLUS SKIN; EQUUS CABALLUS SKIN; FELIS CAT
US HAIR; GALLUS GALLUS FEATHER; MELOPSITTACUS UNDULATUS FEATHER; MERIONES UNGUIC
ULATUS SKIN; MESOCRICETUS AURATUS SKIN; MUS MUSCULUS SKIN; ORYCTOLAGUS CUNICULUS
SKIN; PHOSPHORUS; RATTUS NORVEGICUS SKIN; SERINUS CANARIA FEATHER; STRYCHNOS NU
X-VOMICA SEED; SUS SCROFA SKIN 9; 9; 12; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 12
hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-0985_438193f3-a608-4152-ab85-645fe58047de 57520-0985 HUMAN OTC DRUG
suis, Pituitaria glandula suis, Thyroidinum suis, Bromium, Calcarea carbonica,
Iodium, Lachesis mutus, Pulsatilla," LIQUID ORAL 20111122
UNAPPROVED HOMEOPATHIC Apotheca Company "BROMINE; FUCUS VESICULO
SUS; IODINE; LACHESIS MUTA VENOM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PULSATI
LLA VULGARIS; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA ADRENAL GLAND; S
US SCROFA PITUITARY GLAND; THYROID, PORCINE" 12; 3; 12; 12; 12; 12; 3; 6; 6;
57520-0990_9b79826d-63b2-40b3-9b99-6677acac8eb0 57520-0990 HUMAN OTC DRUG
Venoforce I "Aesculus hippocastanum, Collinsonia canadensis, Echinac
ea, Hamamelis virginiana, Pulsatilla, Arnica Montana, Carbo vegetabilis, Graphit
es,Hydrofluoricum acidum, Lycopodium clavatum, Nitricum acidum, N" LIQUID
"ACTIVATED CHARCOAL; ARNICA MONTANA; COLLINSONIA CANADENSIS ROOT; ECHINACEA, UNS
PECIFIED; GRAPHITE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HORSE CHESTNUT; HY
DROFLUORIC ACID; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; PAEONIA OFFICINALIS ROO
T; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; STRYCHNOS NUX-VOMICA SEED"
12; 12; 3; 3; 12; 3; 3; 12; 12; 12; 12; 3; 12; 12 [hp_X]/mL; [hp_X]/mL; [h
57520-0994_f4805ff4-1849-4036-921b-a5296aabe446 57520-0994 HUMAN OTC DRUG
Hypothalmu Stim "Aralia quinquefolia, Ginkgo biloba, Hydrocotyle asiatic
a, Brain, Hypothalamus, Pituitaria glandula, Phosphorus, Silicea," LIQUID
AMERICAN GINSENG; CENTELLA ASIATICA; GINKGO; PHOSPHORUS; PORK BRAIN; SILICON DIO
XIDE; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PITUITARY GLAND 3; 3; 3; 12; 6;
57520-0998_1872216c-6977-4246-b8e3-13d9a77b70af 57520-0998 HUMAN OTC DRUG
Anpitua Stim "Adrenocorticotrophin, Agnus castus, Baryta carbonica, C
alcarea carbonica, Iodium, Lac caninum, Natrum muriaticum, Phosphoricum acidum,
Sepia, Thyroidinum suis," LIQUID ORAL 20111205 UNAPPROV
ED HOMEOPATHIC Apotheca Company "BARIUM CARBONATE; CANIS LUPUS F
AMILIARIS MILK; CHASTE TREE; CORTICOTROPIN; IODINE; OYSTER SHELL CALCIUM CARBONA
TE, CRUDE; PHOSPHORIC ACID; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE; THYROID, P
ORCINE" 12; 12; 12; 6; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL;
57520-1001_15438445-fcd3-4ce7-a6ad-f88d9102bda8 57520-1001 HUMAN OTC DRUG
Coumarin "Coumarinum," LIQUID ORAL 20111215
UNAPPROVED HOMEOPATHIC Apotheca Company COUMARIN 6
[hp_X]/mL
57520-1002_14c1a052-2969-4337-b161-0115860db155 57520-1002 HUMAN OTC DRUG
Piperine "Piperine," LIQUID ORAL 20111215
UNAPPROVED HOMEOPATHIC Apotheca Company PIPERINE 6
[hp_X]/mL
57520-1003_44d3e789-8dd8-4679-9dc4-9f3371c7e1a0 57520-1003 HUMAN OTC DRUG
Quercetin "Quercetin," LIQUID ORAL 20111216
[hp_X]/mL
57520-1004_8c30f5d4-01a5-400c-a10d-22dd3f365ecc 57520-1004 HUMAN OTC DRUG
Orchiforce "Avena sativa, Damiana, Agnus castus, Caladium seguinum,
Conium maculatum, Phosphoricum acidum, Phosphorus, Picricum acidum," LIQUID
AVENA SATIVA FLOWERING TOP; CHASTE TREE; CONIUM MACULATUM FLOWERING TOP; DIEFFEN
BACHIA SEGUINE; PHOSPHORIC ACID; PHOSPHORUS; TRINITROPHENOL; TURNERA DIFFUSA LEA
FY TWIG 3; 12; 12; 12; 12; 12; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/
57520-1005_fce5f90b-87ed-4531-ab66-0bdb9010228b 57520-1005 HUMAN OTC DRUG
Hepataplex "Beta vulgaris, Boldo, Carduus marianus, Chelidonium maj
us, Petroselinum sativum, Taraxacum officinale, Glutathione, Hepar suis, Lycopod
ium clavatum, Nux vomica, Phosphorus," LIQUID ORAL 20111221
UNAPPROVED HOMEOPATHIC Apotheca Company BETA VULGARIS; CHELIDONI
UM MAJUS; GLUTATHIONE; LYCOPODIUM CLAVATUM SPORE; PETROSELINUM CRISPUM; PEUMUS B
OLDUS LEAF; PHOSPHORUS; PORK LIVER; SILYBUM MARIANUM SEED; STRYCHNOS NUX-VOMICA
SEED; TARAXACUM OFFICINALE 3; 3; 6; 12; 3; 3; 12; 6; 3; 12; 3 [hp_X]/m
57520-1018_6b377da5-4000-4d9b-9948-7314b51d3c79 57520-1018 HUMAN OTC DRUG
Chemtox "Triticum aestivum, Berberis vulgaris, Glycyrrhiza glabra, Lappa
major, Phytolacca decandra, Rhamnus frangula, Rhamnus purshiana, Stillingia syl
vatica, Trifolium pratense, Xanthoxylum fraxineum, Glandu" LIQUID ORAL
"ACETIC ACID; ARCTIUM LAPPA ROOT; ATROPA BELLADONNA; BENZOIC ACID; BENZYL ALCOHO
L; BERBERIS VULGARIS ROOT BARK; BORIC ACID; CHLORINE; CORTICOTROPIN; CORTISONE A
CETATE; ESTRONE; EUGENOL; FRANGULA ALNUS BARK; FRANGULA PURSHIANA BARK; GLYCYRRH
IZA GLABRA; ISOPROPYL PALMITATE; LACTIC ACID, DL-; LEAD; LYCOPODIUM CLAVATUM SPO
RE; NITRIC ACID; PETROLATUM; PHENYLBUTAZONE; PHOSPHORIC ACID; PHOSPHORUS; PHYTOL
ACCA AMERICANA ROOT; PORK LIVER; POTASSIUM SORBATE; RESORCINOL; SALICYLIC ACID;
SORBITOL; STEARYL ALCOHOL; STILLINGIA SYLVATICA ROOT; STRYCHNOS NUX-VOMICA SEED;
SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH; THYROID, PORCINE; TRIFOLIUM PRATENS
E FLOWER; TRITICUM AESTIVUM WHOLE; XYLITOL; ZANTHOXYLUM AMERICANUM BARK"
30; 3; 12; 30; 30; 3; 30; 30; 30; 30; 30; 30; 3; 3; 3; 30; 30; 30; 12; 12; 30; 3
0; 12; 12; 3; 8; 30; 30; 30; 30; 30; 3; 12; 8; 8; 8; 3; 1; 30; 3 [hp_X]/m
57520-1019_eb9a55a2-1816-4bfb-9cb7-0c3368fb7b29 57520-1019 HUMAN OTC DRUG
Cough HP "Arsenicum album, Bryonia, Cuprum aceticum, Drosera, Ipecacuanha
, Kali Carbonicum, Phosphorus, Pulsatilla, Spongia tosta," LIQUID ORAL
"ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CUPRIC ACETATE; DROSERA ROTUNDIFOLIA; IPEC
AC; PHOSPHORUS; POTASSIUM CARBONATE; PULSATILLA VULGARIS; SPONGIA OFFICINALIS SK
ELETON, ROASTED" 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X
L
57520-1021_0cafdd55-113c-4e74-a2d9-025a12bbf555 57520-1021 HUMAN OTC DRUG
Apiol "Apiolum," LIQUID ORAL 20111213 UNAPPROV
ED HOMEOPATHIC Apotheca Company APIOLE (PARSLEY) 6
[hp_X]/mL
57520-1023_8e900056-ae2e-45f6-90a8-c06080ae8ff8 57520-1023 HUMAN OTC DRUG
ASP "Echinacea, Hydrastis canadensis, Tabebuia impetiginosa, Glandul
a suprarenalis suis, Thymus, Thyroidinum, Arsenicum album, Bryonia, Cocculus ind
icus, Colchicum autumnale, Ledum palustre," LIQUID ORAL 20111220
UNAPPROVED HOMEOPATHIC Apotheca Company "ANAMIRTA COCCULUS SEED;
ARSENIC TRIOXIDE; ASPERGILLUS FLAVUS; BRYONIA ALBA ROOT; COLCHICUM AUTUMNALE BU
LB; ECHINACEA, UNSPECIFIED; GOLDENSEAL; LEDUM PALUSTRE TWIG; MERCURIC CYANIDE; P
ULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SODIUM SULFATE; SU
S SCROFA ADRENAL GLAND; SUS SCROFA THYMUS; TABEBUIA IMPETIGINOSA BARK; THYROID,
PORCINE" 12; 12; 30; 12; 12; 3; 3; 12; 12; 12; 12; 12; 12; 8; 8; 3; 8
57520-1024_599c92c5-63f0-4d92-883f-4bec3ee8f5de 57520-1024 HUMAN OTC DRUG
Lym D "Chelidonium majus, Echinacea, Hydrastis canadensis, Nasturtium
aquaticum, Taraxacum officinale, Trifolium pratense, Urtica dioica, Thymus, Thyr
oidinum, Arsenicum album, Coccus cacti," LIQUID ORAL 20111219
UNAPPROVED HOMEOPATHIC Apotheca Company "ARSENIC TRIOXIDE; BORRE
LIA BURGDORFERI; CHELIDONIUM MAJUS; ECHINACEA, UNSPECIFIED; GOLDENSEAL; LEDUM PA
LUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PROTORTONIA CACTI; RORIPPA N
ASTURTIUM-AQUATICUM; SUS SCROFA THYMUS; TARAXACUM OFFICINALE; THYROID, PORCINE;
TOXICODENDRON PUBESCENS LEAF; TRIFOLIUM PRATENSE FLOWER; URTICA DIOICA" 12; 12;
57520-1028_b061e070-5435-4498-ae17-c6826ebdeec8 57520-1028 HUMAN OTC DRUG
Drainage "Echinacea, Phytolacca decandra, Trifolium pratense, Cal
carea iodata, Kali muriaticum, Nitricum acidum, Phosphoricum acidum, Sulphur iod
atum," LIQUID ORAL 20120118 UNAPPROVED HOMEOPATHIC
Apotheca Company "CALCIUM IODIDE; ECHINACEA, UNSPECIFIED; NITRIC ACID; PH
OSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; POTASSIUM CHLORIDE; SULFUR IODIDE; TRI
FOLIUM PRATENSE FLOWER" 12; 3; 12; 12; 3; 12; 12; 3 [hp_X]/mL; [hp_X]/mL; [h
57520-1029_aaa7a7f7-a0a4-4bc6-98bf-b6e50b10dcf2 57520-1029 HUMAN OTC DRUG
FNG I "Echinacea, Hydrastis canadensis, Lomatium dissectum, Nasturtium
aquaticum, Tabebuia impetiginosa, Condurango, Ginkgo biloba, Ligusticum porteri
, Astragalus membranaceus, Propolis, Thymus, Lycopodium c" LIQUID ORAL
"ALTERNARIA ALTERNATA; ASPERGILLUS NIGER; ASTRAGALUS PROPINQUUS ROOT; AUREOBASID
IUM PULLULANS VAR. PULLUTANS; BOS TAURUS ADRENAL GLAND; BOS TAURUS THYMUS; CANDI
DA ALBICANS; CANDIDA PARAPSILOSIS; ECHINACEA, UNSPECIFIED; GINKGO; GOLDENSEAL; L
IGUSTICUM PORTERI ROOT; LOMATIUM DISSECTUM ROOT; LYCOPODIUM CLAVATUM SPORE; MARS
DENIA CONDURANGO BARK; MUCOR RACEMOSUS; PHOSPHORIC ACID; PHYTOLACCA AMERICANA RO
OT; PROPOLIS WAX; RHIZOPUS STOLONIFER; RORIPPA NASTURTIUM-AQUATICUM; SACCHAROMYC
ES CEREVISIAE; SEPIA OFFICINALIS JUICE; STRYCHNOS NUX-VOMICA SEED; TABEBUIA IMPE
TIGINOSA BARK" 12; 12; 6; 12; 8; 8; 12; 12; 3; 4; 3; 4; 3; 12; 4; 12; 12; 12; 6
; 12; 3; 12; 12; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [
57520-1030_1114f327-6b49-4ec5-812e-3659bbab4b57 57520-1030 HUMAN OTC DRUG
FNG II "Echinacea, Hydrastis canadensis, Lomatium dissectum, Nasturtium
aquaticum, Tabebuia impetiginosa, Iodium, Adrenalinum, Argentum metallicum, Thy
mus, Thyroidinum, Phosphoricum acidum, Candida albicans," LIQUID ORAL
"CANDIDA ALBICANS; ECHINACEA, UNSPECIFIED; EPINEPHRINE; GOLDENSEAL; IODINE; LOMA
TIUM DISSECTUM ROOT; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PULSATILLA VULG
ARIS; RORIPPA NASTURTIUM-AQUATICUM; SEPIA OFFICINALIS JUICE; SILVER; SUS SCROFA
THYMUS; TABEBUIA IMPETIGINOSA BARK; THYROID, PORCINE" 12; 3; 8; 3; 6; 3; 30; 1
57520-1031_c7545f0a-8f14-4883-b518-0093311cd240 57520-1031 HUMAN OTC DRUG
Thyro Tonic "Chelidonium majus, Spongia tosta, Lac defloratum, Fucus
vesiculosus, Hepar suis, Pituitary (suis), Thyroidinum (suis), Calcarea carboni
ca, Ferrum iodatum Iodium, Kali iodatum, Molybdenum metallicum, P" LIQUID
"CHELIDONIUM MAJUS; FERROUS IODIDE; FUCUS VESICULOSUS; IODINE; MOLYBDENUM; OYSTE
R SHELL CALCIUM CARBONATE, CRUDE; PORK LIVER; POTASSIUM IODIDE; PULSATILLA VULGA
RIS; SKIM MILK; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA PITUITARY GLAN
D; THYROID, PORCINE" 3; 12; 6; 12; 12; 12; 8; 12; 12; 4; 3; 8; 8 [hp_X]/m
57520-1032_547a701c-afe6-45b0-90ec-1641846e2a26 57520-1032 HUMAN OTC DRUG
Hepatatox "Triticum aestivum, Chelidonium majus, Taraxacum officin
ale, Glutathione, Hepar suis, Thyroidinum (suis), Lycopodium clavatum, Nux vomic
a, Phosphoricum acidum," LIQUID ORAL 20120131 UNAPPROV
ED HOMEOPATHIC Apotheca Company "ACETIC ACID; BENZOIC ACID; BENZ
YL ALCOHOL; BORIC ACID; CHELIDONIUM MAJUS; CHLORINE; CORTICOTROPIN; CORTISONE AC
ETATE; ESTRONE; EUGENOL; GLUTATHIONE; ISOPROPYL PALMITATE; LACTIC ACID, DL-; LEA
D; LYCOPODIUM CLAVATUM SPORE; PETROLATUM; PHENYLBUTAZONE; PHOSPHORIC ACID; PORK
LIVER; POTASSIUM SORBATE; RESORCINOL; SALICYLIC ACID; SORBITOL; STEARYL ALCOHOL;
STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; THYROID, PORCINE; WHEAT; XYLIT
OL" 30; 30; 30; 30; 3; 30; 30; 30; 30; 30; 6; 30; 30; 30; 12; 30; 30; 12; 8;
]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
57520-1034_f40f5154-99aa-4020-b57f-49468c3672ec 57520-1034 HUMAN OTC DRUG
Flu Tonic "Echinacea, Uva-ursi, Baptisia tinctoria, Convallaria ma
jalis, Kali muriaticum, Pinus sylvestris, Thuja occidentalis, Bryonia, Condurang
o, Crotalus horridus, Ginkgo biloba, Lachesis mutus, Selenium met" LIQUID
"ARCTOSTAPHYLOS UVA-URSI LEAF; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CONVA
LLARIA MAJALIS; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA, UNSPECIFIED; GINKGO
; LACHESIS MUTA VENOM; MARSDENIA CONDURANGO BARK; PINUS SYLVESTRIS LEAFY TWIG; P
OTASSIUM CHLORIDE; SELENIUM; TABEBUIA IMPETIGINOSA BARK; THUJA OCCIDENTALIS LEAF
Y TWIG; VISCUM ALBUM FRUITING TOP" 1; 3; 12; 6; 12; 1; 12; 12; 12; 6; 6; 12
hp_X]/mL; [hp_X]/mL
57520-1035_b5d8178c-bc87-4d2d-91aa-e3ac98a3df43 57520-1035 HUMAN OTC DRUG
Lymph II "Echinacea, Phytolacca decandra, Collnsonia canadensis, Kali iod
atum, Pinus sylvestris, Pix liquida, Ferrum phosphoricum, Aesculus hippocastanum
, Baryta carbonica, Berberis vulgaris, Bufo rana, Calcare" LIQUID ORAL
"BARIUM CARBONATE; BERBERIS VULGARIS ROOT BARK; BUFO BUFO CUTANEOUS GLAND; CALCI
UM SULFIDE; CAUSTICUM; COLLINSONIA CANADENSIS ROOT; ECHINACEA, UNSPECIFIED; FERR
UM PHOSPHORICUM; HORSE CHESTNUT; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS;
NITRIC ACID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PHYTOLACCA AMER
ICANA ROOT; PINE TAR; PINUS SYLVESTRIS LEAFY TWIG; POTASSIUM IODIDE; PULSATILLA
VULGARIS; SILICON DIOXIDE; SODIUM CHLORIDE; STELLARIA MEDIA; SULFUR; THUJA OCCID
ENTALIS LEAFY TWIG; TRIBASIC CALCIUM PHOSPHATE; TURPENTINE; WOOD CREOSOTE"
12; 12; 12; 12; 12; 3; 3; 8; 12; 12; 12; 12; 12; 12; 3; 6; 6; 6; 12; 12; 12; 12;
57520-1036_7cd5c595-3a76-4695-bf12-8d379f169458 57520-1036 HUMAN OTC DRUG
Female Stimulant "Aquilegia vulgaris, Hydrastis canadensis, Liliu
m tigrinum, Bovista, Cypripedium pubescens, Apiolum, Apis venenum purum, Cor (su
is), Funiculus umbilicalis suis, Glandula suprarenalis suis, Kreosotum, O"
Company "ACONITIC ACID, (Z)-; ALCALIGENES FAECALIS; APIOLE (PARSLEY); AP
IS MELLIFERA VENOM; AQUILEGIA VULGARIS; CYPRIPEDIUM PARVIFOLUM ROOT; ESCHERICHIA
COLI; ESTRADIOL; ESTRONE; GIANT PUFFBALL; GOLDENSEAL; LACHESIS MUTA VENOM; LILI
UM LANCIFOLIUM FLOWERING TOP; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MERCURIUS
SOLUBILIS; PORK HEART; PROGESTERONE; SEPIA OFFICINALIS JUICE; SUS SCROFA ADRENA
L GLAND; SUS SCROFA OVARY; SUS SCROFA PINEAL GLAND; SUS SCROFA PITUITARY GLAND;
SUS SCROFA PLACENTA; SUS SCROFA UMBILICAL CORD; SUS SCROFA UTERUS; TESTOSTERONE;
WOOD CREOSOTE" 10; 30; 6; 8; 4; 6; 30; 30; 8; 6; 4; 10; 4; 10; 10; 8; 30; 10; 8
; 8; 12; 13; 6; 8; 8; 30; 8 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_
X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/
[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [h
p_X]/mL
57520-1038_9b81bf47-67ca-41a0-b699-31c5243723e3 57520-1038 HUMAN OTC DRUG
Neuro II "Hydrastis canadensis, Taraxacum officinale, Acetylcholine chlor
ide, Adrenalinum, Gaba, Histaminum hydrochloricum, Norepinephrine, Tyramine,"
Company .GAMMA.-AMINOBUTYRIC ACID; ACETYLCHOLINE CHLORIDE; EPINEPHRINE;
GOLDENSEAL; HISTAMINE DIHYDROCHLORIDE; NOREPINEPHRINE; TARAXACUM OFFICINALE; TYR
AMINE 6; 6; 6; 3; 6; 6; 3; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_
57520-1039_61736877-7215-416c-bca1-67bbedb38539 57520-1039 HUMAN OTC DRUG
Phenylalanine "Phenylalanine," LIQUID ORAL 20100130
UNAPPROVED HOMEOPATHIC Apotheca Company PHENYLALANINE 6
[hp_X]/mL
57520-1040_78b1ab82-00ef-4b5a-94ae-ecc5cc94db39 57520-1040 HUMAN OTC DRUG
Pyrrole "Pyrrole," LIQUID ORAL 20120116 UNAPPROV
ED HOMEOPATHIC Apotheca Company PYRROLE 6 [hp_X]/mL
57520-1041_af5e0622-2e07-49fc-aaca-801ee8c30110 57520-1041 HUMAN OTC DRUG
Sore Throat "Juglans regia, Myosotis arvensis, Scrophularia nodosa,
Teucrium scorodonia, Veronica officinalis, Equisetum hyemale, Fumaria officinali
s, Geranium robertianum, Nasturtium aquaticum, Natrum sulphuricum" LIQUID
"ARANEUS DIADEMATUS; EQUISETUM HYEMALE; FERROUS IODIDE; FUMARIA OFFICINALIS FLOW
ERING TOP; GENTIANA LUTEA ROOT; GERANIUM ROBERTIANUM; JUGLANS REGIA FLOWERING TO
P; MYOSOTIS ARVENSIS; PINUS SYLVESTRIS LEAFY TWIG; RORIPPA NASTURTIUM-AQUATICUM;
SCROPHULARIA NODOSA; SMILAX REGELII ROOT; SUS SCROFA LYMPH; TEUCRIUM SCORODONIA
FLOWERING TOP; THYROID, PORCINE; TRIBASIC CALCIUM PHOSPHATE; VERONICA OFFICINAL
IS FLOWERING TOP" 6; 4; 12; 4; 5; 4; 3; 3; 4; 4; 3; 6; 12; 3; 12; 12; 3
57520-1042_c5e4eaaa-046d-4317-bc13-ae2cff91dd96 57520-1042 HUMAN OTC DRUG
Bacto Plus "Baptisia tinctoria, Echinacea, Phytolacca decandra, Aco
, Phosphorus," LIQUID ORAL 20111230 UNAPPROVED HOMEOPATHIC
Apotheca Company "ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA;
BAPTISIA TINCTORIA ROOT; ECHINACEA, UNSPECIFIED; FERRUM PHOSPHORICUM; LACHESIS
MUTA VENOM; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT" 12; 12; 12; 3; 3; 12; 12
57520-1043_5f5183c1-998a-436a-bee3-953d3485a218 57520-1043 HUMAN OTC DRUG
Bacto Plus HP "Apis mellifica, Arsenicum album, Belladonna, Chamomilla
, Echinacea, Lachesis mutus, Mercurius solubilis, Pulsatilla, Pyrogenium, Rhus t
oxicodendron, Silicea," LIQUID ORAL 20111230 UNAPPROVED HOMEO
PATHIC Apotheca Company "APIS MELLIFERA; ARSENIC TRIOXIDE; ATROP
A BELLADONNA; ECHINACEA, UNSPECIFIED; LACHESIS MUTA VENOM; MATRICARIA RECUTITA;
MERCURIUS SOLUBILIS; PULSATILLA VULGARIS; RANCID BEEF; SILICON DIOXIDE; TOXICODE
NDRON PUBESCENS LEAF" 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/m
57520-1044_5573ccc3-d2ff-42bc-aa44-dc8232242ce5 57520-1044 HUMAN OTC DRUG
Viro Plus "Echinacea, Hydrastis canadensis, Lomatium, Aconitum nap
UNAPPROVED HOMEOPATHIC Apotheca Company "ACONITUM NAPELLUS; ARSE
NIC TRIOXIDE; ATROPA BELLADONNA; ECHINACEA, UNSPECIFIED; EUPATORIUM PERFOLIATUM
FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; LACHESIS MUTA VENOM; LOM
ATIUM DISSECTUM ROOT; RANCID BEEF; TOXICODENDRON PUBESCENS LEAF" 12; 12;
57520-1045_041df92b-2f51-47d4-8e1c-2e1e31dc8461 57520-1045 HUMAN OTC DRUG
Fungal Plus "Candida albicans," LIQUID ORAL 20111230
6 [hp_X]/mL
57520-1046_3bb65ce2-d1ec-4fb8-962d-cbbee117ae89 57520-1046 HUMAN OTC DRUG
Lymph Plus "Geranium robertianum, Nasturtium aquaticum, Aloe socotr
ina, Juglans regia, Myosotis, arvensis, Scrophularia nodosa, Teucrium scordonia,
Apis mellifica, Equisetum hyemale, Fumaria officinalis, Natrum s" LIQUID
"ALOE; APIS MELLIFERA; BARIUM CARBONATE; CALCIUM SULFIDE; EQUISETUM HYEMALE; FUM
ARIA OFFICINALIS FLOWERING TOP; GENTIANA LUTEA ROOT; GERANIUM ROBERTIANUM; JUGLA
NS REGIA FLOWERING TOP; MYOSOTIS ARVENSIS; PHYTOLACCA AMERICANA ROOT; PINUS SYLV
ESTRIS FLOWERING TOP; RORIPPA NASTURTIUM-AQUATICUM; SCROPHULARIA NODOSA; SMILAX
REGELII ROOT; SODIUM SULFATE; SUS SCROFA PARATHYROID GLAND; SUS SCROFA THYMUS; T
EUCRIUM SCORODONIA FLOWERING TOP; THYROID, PORCINE; VERONICA OFFICINALIS FLOWERI
NG TOP" 3; 4; 8; 8; 4; 4; 5; 3; 3; 3; 4; 4; 3; 3; 6; 4; 12; 12; 3; 12; 4
57520-1047_00b153a6-4f36-464d-b9eb-9cf0a07829f4 57520-1047 HUMAN OTC DRUG
Dr. Pearsalls 500 Calorie Diet Protocol Drops "Fucus vesiculosus, Cyanocobalam
in, Glandula suprarenalis suis, Hepar suis, L-carnitine, L-ornithine, Antimonium
crudum, Thyroidinum suis, Natrum sulphuricum, Pancreatinum, Hypothalamus (suis)
Apotheca Company "ANTIMONY TRISULFIDE; CYANOCOBALAMIN; FUCUS VESICULOSUS;
LEVOCARNITINE; ORNITHINE; PANCRELIPASE; PORK LIVER; SODIUM SULFATE; SUS SCROFA
ADRENAL GLAND; SUS SCROFA HYPOTHALAMUS; THYROID, PORCINE" 8; 6; 2; 6; 6; 1
57520-1049_5e2a7e57-649e-46cf-897e-72e0a2e43894 57520-1049 HUMAN OTC DRUG
Human Parvovirus Remedy Parvovirus LIQUID ORAL 20120208
UNAPPROVED HOMEOPATHIC Apotheca Company HUMAN PARVOVIRUS B19
15 [hp_X]/mL
57520-1051_d00da8fd-14d0-40fb-9c3a-69e2643df745 57520-1051 HUMAN OTC DRUG
Evtox "Cochlearia officinalis, Echinacea, Hydrastis canadensis, Lomati
um dissectum, Tabebuia impetiginosa, Propolis, Glandula suprarenalis suis, Thymu
s (suis), Aranea diadema, Ipecacuanha," LIQUID ORAL 20120126
UNAPPROVED HOMEOPATHIC Apotheca Company "ARANEUS DIADEMATUS; COC
HLEARIA OFFICINALIS FLOWERING TOP; ECHINACEA, UNSPECIFIED; GOLDENSEAL; HUMAN HER
PESVIRUS 4; HYDROCHLORIC ACID; IPECAC; LOMATIUM DISSECTUM ROOT; LYCOPODIUM CLAVA
TUM SPORE; NITRIC ACID; PROPOLIS WAX; SILICON DIOXIDE; SUS SCROFA ADRENAL GLAND;
SUS SCROFA THYMUS; TABEBUIA IMPETIGINOSA BARK; TOXICODENDRON PUBESCENS LEAF"
12; 3; 3; 3; 30; 12; 12; 3; 12; 12; 6; 12; 8; 8; 3; 12 [hp_X]/mL; [hp_X]/mL; [h
57520-1052_b7637a5d-54cf-4352-bdad-9e3df29623f6 57520-1052 HUMAN OTC DRUG
Nephroplex "Berberis vulgaris, Hydrangea arborescens, Petroselinum
sativum, Solidago virgaurea, Uva-ursi, Rubia tinctorum, Glutathiona, Kidney (sui
s), Bryonia, Eupatorium purpureum, Mercurius corrosivus," LIQUID ORAL
ARCTOSTAPHYLOS UVA-URSI LEAF; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; EU
TROCHIUM PURPUREUM ROOT; GLUTATHIONE; HYDRANGEA ARBORESCENS ROOT; MERCURIC CHLOR
IDE; PETROSELINUM CRISPUM; PORK KIDNEY; RUBIA TINCTORUM ROOT; SOLIDAGO VIRGAUREA
FLOWERING TOP 3; 3; 12; 12; 6; 3; 12; 3; 6; 5; 3 [hp_X]/mL; [hp_X]/mL; [h
]/mL; [hp_X]/mL
57520-1053_816fd2a4-d679-4476-ae7a-7b7cfa2486bd 57520-1053 HUMAN OTC DRUG
Pancreaplex "Chelidonium majus, Glycyrrhiza glabra, Hydrastis canade
nsis, Nux moschata, Rheum officinale, Syzygium jambolanum, Taraxacum officinale,
Zingiber officinale, Glandula suprarenalis suis, Hepar suis, Pan" LIQUID
"CHELIDONIUM MAJUS; GINGER; GLYCYRRHIZA GLABRA; GOLDENSEAL; KIDNEY BEAN; NUTMEG;
PHOSPHORIC ACID; PHOSPHORUS; PORK LIVER; RHEUM OFFICINALE ROOT; SUS SCROFA ADRE
NAL GLAND; SUS SCROFA PANCREAS; SUS SCROFA PITUITARY GLAND; SYZYGIUM CUMINI SEED
; TARAXACUM OFFICINALE; THYROID, PORCINE" 3; 3; 3; 3; 12; 3; 12; 12; 6; 3;
57520-1056_3a74036c-c863-4d01-937a-0b7894b306ce 57520-1056 HUMAN OTC DRUG
Mentox HP "Baryta carbonica, Calcarea carbonica, Lachesis mutus, Lycopodiu
m clavatum, Natrum muriaticum, Nux vomica, Phosphorus," LIQUID ORAL 20120120
UNAPPROVED HOMEOPATHIC Apotheca Company "BARIUM CARBONATE; LACHE
SIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; OYSTER SHELL CALCIUM CARBONATE, CRUDE
; PHOSPHORUS; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED" 30; 30; 30; 30;
; [hp_X]/mL
57520-1111_0a0329cb-24eb-4618-884a-efee16a5b1b5 57520-1111 HUMAN OTC DRUG
H Acne Formula "Calendula officinalis, Nux vomica, Silicea," OIL
CALENDULA OFFICINALIS FLOWERING TOP; SILICON DIOXIDE; STRYCHNOS NUX-VOMICA SEED
12; 12; 12 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL
57520-1147_c6cf79b2-d44f-4a86-b79e-ce7972049a6d 57520-1147 HUMAN OTC DRUG
HZ Formula "Baptisia tinctoria, Echinacea, Lomatium dissectum, Tabe
buia impetiginosa, Propolis, Spleen (suis), Thymus (suis), Thyroidinum (suis), G
elsemium sempervirens, Lycopodium clavatum, Nux vomica," LIQUID ORAL
"BAPTISIA TINCTORIA ROOT; CANDIDA ALBICANS; CHLAMYDIA TRACHOMATIS; ECHINACEA, UN
SPECIFIED; GELSEMIUM SEMPERVIRENS ROOT; HUMAN HERPESVIRUS 1; HUMAN HERPESVIRUS 2
; HUMAN PAPILLOMAVIRUS; LOMATIUM DISSECTUM ROOT; LYCOPODIUM CLAVATUM SPORE; PROP
OLIS WAX; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; TABEB
UIA IMPETIGINOSA BARK; THYROID, PORCINE; TRICHINELLA BRIVOTI" 3; 30; 30; 3; 12
; 30; 30; 30; 3; 12; 6; 12; 6; 6; 3; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL;
57520-1251_9f627670-07a7-409f-b440-1595e21550a9 57520-1251 HUMAN OTC DRUG
Cough and Cold Relief "Allium Cepa, Arsenicum Album, Ferrum Phosphoric
um, Lac Caninum, Natrum Muriaticum, Nux Vomica" TABLET ORAL 20130830
UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; CANIS
LUPUS FAMILIARIS MILK; FERROSOFERRIC PHOSPHATE; ONION; SODIUM CHLORIDE; STRYCHNO
S NUX-VOMICA SEED 30; 30; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [h
p_C]/1; [hp_C]/1; [hp_C]/1
12634-530_25438014-410b-48aa-b81f-d9d0f1f98435 12634-530 HUMAN PRESCRIPTI
ON DRUG DIETHYLPROPION HYDROCHLORIDE DIETHYLPROPION HYDROCHLORIDE
TABLET ORAL 19990816 ANDA ANDA011722 Apotheca Inc
DIETHYLPROPION HYDROCHLORIDE 25 mg/1 "Appetite Suppression [PE],Incre
ased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]" CIV
12634-691_25438014-410b-48aa-b81f-d9d0f1f98435 12634-691 HUMAN PRESCRIPTI
ON DRUG DIETHYLPROPION HYDROCHLORIDE ER DIETHYLPROPION HYDROCHLORIDE ER
TABLET ORAL 20081023 ANDA ANDA011722 Apotheca Inc
DIETHYLPROPION HYDROCHLORIDE 75 mg/1 "Appetite Suppression [PE],Incre
12634-118_8ef862cd-d11d-4f51-a518-a8fcd12b53cb 12634-118 HUMAN PRESCRIPTI
ON DRUG BENZPHETAMINE hYDROCHLORIDE BENAPHETAMINE TABLET ORAL
20091209 ANDA ANDA040747 Apotheca Inc. BENZPHETAMINE HY
DROCHLORIDE 50 mg/1 "Appetite Suppression [PE],Increased Sympathetic
Activity [PE],Sympathomimetic Amine Anorectic [EPC]" CIII
12634-166_d1473f26-2631-4493-87ef-8328b12e8e1a 12634-166 HUMAN PRESCRIPTI
ANDA040094 Apotheca Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 650; 7.5
12634-177_db550e63-43dc-4126-b857-010383501dd0 12634-177 HUMAN PRESCRIPTI
ON DRUG Sulfamethoxazole and Trimethoprim DS Sulfamethoxazole and Tri
methoprim DS TABLET ORAL 19940621 ANDA ANDA076899
Apotheca Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1
"Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P
450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],D
ihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Org
anic Cation Transporter 2 Inhibitors [MoA]"
12634-183_9ae064b6-e159-4b0e-a4c5-cc92229b2250 12634-183 HUMAN PRESCRIPTI
ON DRUG AMOXICILLIN AMOXICILLIN CAPSULE ORAL 20050308
ANDA ANDA065271 Apotheca Inc. AMOXICILLIN 250 mg/1
12634-185_9ae064b6-e159-4b0e-a4c5-cc92229b2250 12634-185 HUMAN PRESCRIPTI
ON DRUG AMOXICILLIN AMOXICILLIN CAPSULE ORAL 20050308
ANDA ANDA065271 Apotheca Inc. AMOXICILLIN 500 mg/1
12634-264_223ae6bd-ab66-4870-8298-481309c24474 12634-264 HUMAN PRESCRIPTI
ON DRUG Hydrocodone Bitartrate with Acetaminophen Hydrocodone Bita
rtrate with Acetaminophen TABLET ORAL 20090312 ANDA
ANDA040099 Apotheca Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5
12634-514_bb67a4ea-93c6-4d72-b67e-28fb7c227685 12634-514 HUMAN PRESCRIPTI
ANDA089883 Apotheca Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 5
12634-860_6e315790-ef94-4772-8e76-2565f8b097d4 12634-860 HUMAN OTC DRUG
IBUPROFEN IBUPROFEN TABLET ORAL 20090916
ANDA ANDA071333 Apotheca Inc. IBUPROFEN 200 mg/1
12634-987_4ff5ce14-77ce-4757-a40e-e7099f15a011 12634-987 HUMAN OTC DRUG
CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE TABLET
ORAL 20100101 ANDA ANDA076677 Apotheca Inc. CETIRIZI
57520-0220_de5f747c-5ac9-4ddc-aa30-88fd4f07390d 57520-0220 HUMAN OTC DRUG
1 Bladder "Berberis vulgaris, Thuja occidentalis, Apis mellifica,
Pulsatilla, Staphysagria, Baryta carbonica, Bryonia, Hepar sulphuris calcareum"
LIQUID ORAL 20100512 UNAPPROVED HOMEOPATHIC "Apothec
a, Company" APIS MELLIFERA; BARIUM CARBONATE; BERBERIS VULGARIS ROOT BARK; B
RYONIA ALBA ROOT; CALCIUM SULFIDE; DELPHINIUM STAPHISAGRIA SEED; PULSATILLA VULG
ARIS; THUJA OCCIDENTALIS LEAFY TWIG 200; 1; 3; 1; 1; 200; 200; 30 [hp_C]/m
L; [hp_M]/mL; [hp_X]/mL; [hp_M]/mL; [hp_M]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL
57520-0258_c3df9717-a817-41e6-b507-5cf3370a5857 57520-0258 HUMAN OTC DRUG
UNAPPROVED HOMEOPATHIC "Apotheca, Company" CANDIDA ALBICANS
500 [hp_X]/mL
57520-0371_dbf289ad-3ff4-458f-aeaa-57e6987590e0 57520-0371 HUMAN OTC DRUG
Otoflam HP "Belladonna , Conium maculatum, Dulcamara, Ferrum phosphoricum,
Hepar sulphuris calcareum, Kali bichromicum, mercurius solubilis, Pulsatilla, Si
licea, Chamonilla" LIQUID ORAL 20100608 UNAPPROVED HOMEO
PATHIC "Apotheca, Company" ATROPA BELLADONNA; CALCIUM SULFIDE; CONI
UM MACULATUM FLOWERING TOP; FERRUM PHOSPHORICUM; MATRICARIA RECUTITA; MERCURIUS
SOLUBILIS; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SILICON DIOXIDE; SOLANUM D
ULCAMARA TOP 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [h
p_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X
]/mL
12634-111_131d4041-7086-411f-ab71-37c091d1377a 12634-111 HUMAN OTC DRUG
OTC MONOGRAPH NOT FINAL part343 "Apotheca, Inc" ACETAMINOPHEN 325 mg/1
12634-120_9e5f53d8-1f64-4021-8b6e-7f74694919ab 12634-120 HUMAN OTC DRUG
Aspirin Aspirin TABLET ORAL 19830415 OTC MONOGRAPH NO
T FINAL part343 "Apotheca, Inc" ASPIRIN 325 g/1
12634-452_35d798c1-9d09-44c0-8a23-32f76f2f2b23 12634-452 HUMAN PRESCRIPTI
ANDA ANDA090278 "APOTHECA, INC" TOPIRAMATE 25 mg/1 "Anti-ep
ivity [PE]"
12634-453_35d798c1-9d09-44c0-8a23-32f76f2f2b23 12634-453 HUMAN PRESCRIPTI
ON DRUG TOPIRAMATE TOPIRAMATE TABLET ORAL 20100513
ANDA ANDA090278 "APOTHECA, INC" TOPIRAMATE 50 mg/1 "Anti-ep
ivity [PE]"
12634-465_91f3b736-ecf5-4517-b8d9-a151308db836 12634-465 HUMAN PRESCRIPTI
ON DRUG Clonidine HYDROCHLORIDE Clonidine HYDROCHLORIDE TABLET ORAL
19961221 ANDA ANDA070974 "Apotheca, Inc" CLONIDINE HYDROC
HLORIDE 0.1 mg/1 "Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrene
rgic Agonist [EPC]"
12634-518_2757f53a-602c-4678-80f5-61c3d9dfd4a3 12634-518 HUMAN PRESCRIPTI
ANDA ANDA091239 "Apotheca, Inc" IBUPROFEN 200 mg/1 "Cycloox
12634-531_9f70ec39-a095-4f05-b71a-fea9e641b543 12634-531 HUMAN PRESCRIPTI
ON DRUG Diphenoxylate Hydrochloride and Atropine Sulfate Diphenox
ylate Hydrochloride and Atropine Sulfate TABLET ORAL 20090825
ANDA ANDA085762 "APOTHECA, INC" ATROPINE SULFATE; DIPHENOXYLATE HYDROCHL
ORIDE .025; 2.5 mg/1; mg/1 "Antidiarrheal [EPC],Anticholinergic [EP
C],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Choline
rgic Muscarinic Antagonists [MoA]" CV
12634-615_b97e818f-af7d-450b-8337-789ef40ec114 12634-615 HUMAN PRESCRIPTI
rtrate and Acetaminophen SOLUTION ORAL 20130618
ANDA ANDA040182 "APOTHECA, INC" ACETAMINOPHEN; HYDROCODONE BITARTRATE
167; 2.5 mg/5mL; mg/5mL "Opioid Agonist [EPC],Opioid Agonists [MoA]"
CIII
12634-616_454f7e01-52bf-4169-9a52-0ea3aad000b1 12634-616 HUMAN PRESCRIPTI
ON DRUG Hydrocodone Bitartrate and Acetaminophen hydrocodone bita
rtrate and acetaminophen SOLUTION ORAL 20140331
ANDA ANDA040838 "Apotheca, Inc" ACETAMINOPHEN; HYDROCODONE BITARTRATE
325; 7.5 mg/120mL; mg/120mL "Opioid Agonist [EPC],Opioid Agonists [M
oA]" CIII
12634-786_a5531d3d-ffce-4a3f-88f9-59626dd98c91 12634-786 HUMAN PRESCRIPTI
ON DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET ORAL
20050426 ANDA ANDA075964 "APOTHECA, INC" TRAMADOL HYDROCH
LORIDE 50 mg/1 "Full Opioid Agonists [MoA],Opioid Agonist [EPC]"
12634-809_69956c5a-014b-4e75-b4c1-6e51d7e80315 12634-809 HUMAN PRESCRIPTI
ON DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET ORAL
20051025 ANDA ANDA074754 "Apotheca, Inc" KETOROLAC TROMET
HAMINE 10 mg/1 "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-infla
]"
12634-827_bf8d9912-f32f-41d3-8173-a60c80fddc77 12634-827 HUMAN PRESCRIPTI
ON DRUG DICLOFENAC POTASSIUM DICLOFENAC POTASSIUM TABLET ORAL
20070820 ANDA ANDA075229 "APOTHECA, INC" DICLOFENAC POTAS
SIUM 50 mg/1 "Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin
Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],
12634-907_60afef1d-5844-48c5-8194-a817bccf1ed5 12634-907 HUMAN PRESCRIPTI
ON DRUG Promethazine Hydrochloride and Codeine Phosphate Prometha
zine Hydrochloride and Codeine Phosphate SYRUP ORAL 20120216
ANDA ANDA090180 "APOTHECA, INC" CODEINE PHOSPHATE; PROMETHAZINE HYDROCHL
12634-933_51ae34a7-a5eb-47de-8798-60e55a1db305 12634-933 HUMAN PRESCRIPTI
ON DRUG CYTOTEC MISOPROSTOL TABLET ORAL 20100101
NDA NDA019268 "Apotheca, Inc" MISOPROSTOL 200 ug/1 "Prostag
landin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient]"
12634-942_07f367ed-e5b9-40ec-b812-f5d5a5f7a774 12634-942 HUMAN PRESCRIPTI
TABLET ORAL 20070723 ANDA ANDA040330 "Apotheca, Inc"
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 5 mg/1; mg/1 "Full Opioid Ago
12634-943_9fd5fff8-1baf-4d32-b4d8-9c6fd1de45d4 12634-943 HUMAN PRESCRIPTI
20070725 ANDA ANDA077884 "APOTHECA, INC" ZOLPIDEM TARTRAT
E 5 mg/1 "gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agon
]" CIV
12634-944_9fd5fff8-1baf-4d32-b4d8-9c6fd1de45d4 12634-944 HUMAN PRESCRIPTI
20070925 ANDA ANDA077884 "APOTHECA, INC" ZOLPIDEM TARTRAT
E 10 mg/1 "gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agon
]" CIV
12634-969_5a66f7eb-5670-4ee1-b48f-0d0a11b554c6 12634-969 HUMAN OTC DRUG
Guaifenesin and Codeine Phosphate Guaifenesin and Codeine Phosphat
e SOLUTION ORAL 20110128 OTC MONOGRAPH FINAL
part341 "Apotheca, Inc" CODEINE PHOSPHATE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL
CV
12634-028_763b33f0-84dd-4bd0-9122-21245c0d515f 12634-028 HUMAN PRESCRIPTI
ON DRUG PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE
TABLET ORAL 20100401 ANDA ANDA089452 "Apotheca, Inc."
12634-129_cb04a343-5607-44df-b8f0-0514808d789b 12634-129 HUMAN PRESCRIPTI
ON DRUG Vicodin ES HYDROCODONE BITARTRATE TABLET ORAL 20091214
ANDA ANDA089736 "Apotheca, Inc." ACETAMINOPHEN; HYDROCODONE BITAR
oA]" CIII
12634-144_34b8c713-f662-4ded-a3ad-4611bbfe3e2a 12634-144 HUMAN PRESCRIPTI
ANDA040746 "Apotheca, Inc." ACETAMINOPHEN; HYDROCODONE BITARTRATE
12634-160_543aa8e5-219e-41d8-8ffa-9ae1446d3391 12634-160 HUMAN PRESCRIPTI
ON DRUG INDOMETHACIN ER INDOMETHACIN CAPSULE ORAL 20100304
ANDA ANDA079175 "Apotheca, Inc." INDOMETHACIN 75 mg/1
12634-171_c9a9b795-1424-4ccb-bd87-991833ca08e2 12634-171 HUMAN PRESCRIPTI
ON DRUG IBUPROFEN IBUPROFEN TABLET ORAL 19910211
ANDA ANDA075682 "Apotheca, Inc." IBUPROFEN 400 mg/1
12634-179_0048d662-23c4-4e28-815e-ce094951da05 12634-179 HUMAN PRESCRIPTI
ON DRUG METHERGINE METHYLERGONOVINE MALEATE "TABLET, COATED"
ORAL 20061227 NDA NDA006035 "Apotheca, Inc."
METHYLERGONOVINE MALEATE 0.2 mg/1 "Ergolines [Chemical/Ingredient]
,Ergot Derivative [EPC]"
12634-260_22c1eeb7-1806-4493-b0a0-fd4127f6d908 12634-260 HUMAN PRESCRIPTI
rtrate and Acetaminphen TABLET ORAL 20140108 ANDA ANDA0901
18 "Apotheca, Inc." ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5
12634-437_2c1558dc-1b76-4165-b872-ad35648676cf 12634-437 HUMAN PRESCRIPTI
ON DRUG CARISOPRODOL CARISOPRODOL TABLET ORAL 20100210
ANDA ANDA089346 "Apotheca, Inc." CARISOPRODOL 350 mg/1
"Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]" CIV
12634-438_746b74f0-81e8-4cf1-9b21-19309709ea81 12634-438 HUMAN PRESCRIPTI
ON DRUG Carisoprodol and Aspirin Carisoprodol and Aspirin
ASPIRIN; CARISOPRODOL 325; 200 mg/1; mg/1 "Centrally-mediated Musc
le Relaxation [PE],Muscle Relaxant [EPC],Cyclooxygenase Inhibitors [MoA],Decreas
ed Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemi
12634-445_f603db60-428d-470d-96d6-2c9486dfa784 12634-445 HUMAN PRESCRIPTI
ON DRUG HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE TABLET ORAL
19961221 ANDA ANDA084325 "Apotheca, Inc." HYDROCHL
12634-471_f603db60-428d-470d-96d6-2c9486dfa784 12634-471 HUMAN PRESCRIPTI
ON DRUG HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE TABLET ORAL
20090630 ANDA ANDA084324 "Apotheca, Inc." HYDROCHL
12634-502_f01449fe-8751-43b6-b1c2-89a7f920f2e2 12634-502 HUMAN PRESCRIPTI
ON DRUG MISOPROSTOL MISOPROSTOL TABLET ORAL 19970917
NDA NDA019268 "Apotheca, Inc." MISOPROSTOL 200 ug/1
"Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient]
"
12634-516_a39c59dd-024e-45e3-a18c-d24979112fa8 12634-516 HUMAN PRESCRIPTI
ON DRUG PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE
CAPSULE ORAL 19980601 ANDA ANDA040875 "Apotheca, Inc."
PHENTERMINE HYDROCHLORIDE 30 mg/1 "Appetite Suppression [PE],Incre
12634-526_01bcf883-dd64-47a9-8576-ae6ddcdb6cce 12634-526 HUMAN PRESCRIPTI
ON DRUG ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN AND CODEIN
E PHOSPHATE TABLET ORAL 20020503 ANDA ANDA089805
"Apotheca, Inc." ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg
12634-529_7f85d8a7-0144-44d4-9a61-fb24a144d5c8 12634-529 HUMAN PRESCRIPTI
ON DRUG DIAZEPAM DIAZEPAM TABLET ORAL 20091209
ANDA ANDA071321 "Apotheca, Inc." DIAZEPAM 5 mg/1
12634-537_ab220c1d-8551-4a9d-b4d3-9199121420df 12634-537 HUMAN PRESCRIPTI
ON DRUG PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN PROPOXYPHENE NAP
SYLATE AND ACETAMINOPHEN "TABLET, FILM COATED" ORAL 20090101
ANDA ANDA074119 "Apotheca, Inc." ACETAMINOPHEN; PROPOXYPHENE NAPS
st [EPC]" CIV
12634-539_763b33f0-84dd-4bd0-9122-21245c0d515f 12634-539 HUMAN PRESCRIPTI
12634-553_f8ec8a93-e57a-4f34-8d2c-fdd0f2be3306 12634-553 HUMAN PRESCRIPTI
PHENTERMINE HYDROCHLORIDE 37.5 mg/1 "Appetite Suppression [PE],Incre
12634-687_f8ec8a93-e57a-4f34-8d2c-fdd0f2be3306 12634-687 HUMAN PRESCRIPTI
12634-698_7f85d8a7-0144-44d4-9a61-fb24a144d5c8 12634-698 HUMAN PRESCRIPTI
ON DRUG DIAZEPAM DIAZEPAM TABLET ORAL 20090115
ANDA ANDA070154 "Apotheca, Inc." DIAZEPAM 10 mg/1
12634-779_51ea5805-beef-4741-a63e-76bf0fe03153 12634-779 HUMAN PRESCRIPTI
ON DRUG SULFAMETHOXAZOLE and TRIMETHOPRIM SULFAMETHOXAZOLE and TRI
METHOPRIM SUSPENSION ORAL 20091103 ANDA ANDA0746
50 "Apotheca, Inc." SULFAMETHOXAZOLE; TRIMETHOPRIM 200; 40 mg/5mL;
mg/5mL "Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cyto
12634-782_58d64590-3142-4ba9-9777-7174049514c5 12634-782 HUMAN PRESCRIPTI
ON DRUG BONTRIL PHENDIMETRAZINE TARTRATE CAPSULE ORAL 20100408
ANDA ANDA088021 "Apotheca, Inc." PHENDIMETRAZINE TARTRATE
105 mg/1 "Appetite Suppression [PE],Increased Sympathetic Activity [PE],S
ympathomimetic Amine Anorectic [EPC]" CIII
12634-838_543aa8e5-219e-41d8-8ffa-9ae1446d3391 12634-838 HUMAN PRESCRIPTI
ON DRUG INDOMETHACIN ER INDOMETHACIN CAPSULE ORAL 20060502
ANDA ANDA074464 "Apotheca, Inc." INDOMETHACIN 75 mg/1
12634-908_6bd465a1-3575-4d4a-9887-e25835cbd5bc 12634-908 HUMAN PRESCRIPTI
ON DRUG PROMETHAZINE WITH CODEINE PROMETHAZINE WITH CODEINE
LIQUID ORAL 20100101 ANDA ANDA088875 "Apotheca, Inc."
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10; 6.25 mg/5mL; mg/5mL
"Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient]" CV
12634-909_6bd465a1-3575-4d4a-9887-e25835cbd5bc 12634-909 HUMAN PRESCRIPTI
ON DRUG PROMETHAZINE WITH CODEINE PROMETHAZINE WITH CODEINE
LIQUID ORAL 20090601 ANDA ANDA040151 "Apotheca, Inc."
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10; 6.25 mg/5mL; mg/5mL
"Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient]" CV
12634-910_68209b15-ba77-478f-a715-e3c8a17d7b61 12634-910 HUMAN PRESCRIPTI
12634-980_f01449fe-8751-43b6-b1c2-89a7f920f2e2 12634-980 HUMAN PRESCRIPTI
ON DRUG MISOPROSTOL MISOPROSTOL TABLET ORAL 20100225
ANDA ANDA076095 "Apotheca, Inc." MISOPROSTOL 100 ug/1
"Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient]
"
57520-0144_93793271-55d2-48b4-a921-83f1759236ce 57520-0144 HUMAN OTC DRUG
Neuro Balance Pro "Adrenocorticotrophin, Gaba, Glutamic acid, Nore
pinephrine, Acetylcholine chloride, Adrenalinum" SPRAY ORAL 20100407
UNAPPROVED HOMEOPATHIC ApothecaCompany ".GAMMA.-AMINOBUTYRIC ACID; ACET
YLCHOLINE CHLORIDE; BARIUM CARBONATE; CORTICOTROPIN; DATURA STRAMONIUM; EPINEPHR
INE; GLUTAMIC ACID; LEVODOPA; NOREPINEPHRINE; OYSTER SHELL CALCIUM CARBONATE, CR
UDE; SEMECARPUS ANACARDIUM JUICE; SEROTONIN; THYROID" 3; 1; 200; 30; 1; 1; 3;
1; 30; 200; 200; 1; 12 [hp_C]/mL; [hp_M]/mL; [hp_C]/mL; [hp_X]/mL; [hp_M]/mL; [
hp_M]/mL; [hp_C]/mL; [hp_M]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_M]/mL; [hp_
C]/mL
49762-450_41cd1174-13f5-4a50-8955-9f1cf9fc398e 49762-450 HUMAN OTC DRUG
Earwax Removal Earwax Removal LIQUID AURICULAR (OTIC) 20080831
OTC MONOGRAPH FINAL part344 "Apothecary Products, LLC" CARBAMIDE PEROXI
DE 6.5 mg/100mL
49762-453_391897b2-7553-4c30-b756-9ac7e7b18e27 49762-453 HUMAN OTC DRUG
Earwax Removal Aid Earwax Removal Aid LIQUID AURICULAR (OTIC)
20100831 OTC MONOGRAPH FINAL part344 "Apothecary Products, LL
C" CARBAMIDE PEROXIDE 6.5 mg/100mL
42852-001_e846c0f9-f552-4f43-92f4-8541668912af 42852-001 HUMAN PRESCRIPTI
ON DRUG Ciprofloxacin Hydrochloride Ciprofloxacin Hydrochloride
TABLET ORAL 20110701 ANDA ANDA075593 Apothecary Shop
Wholesale Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 "Quinolone Antim
42852-002_0cf70670-7217-46be-9a64-27beb7b9d02b 42852-002 HUMAN PRESCRIPTI
ATED" ORAL 20110701 ANDA ANDA065095 Apothecary Shop
Wholesale Inc. DOXYCYCLINE HYCLATE 100 mg/1
42852-003_c78e92fe-c381-4afa-b221-c03cc5e391d7 42852-003 HUMAN PRESCRIPTI
ANDA ANDA076077 Apothecary Shop Wholesale Inc. FLUCONAZOLE 150
bitors [MoA]"
57520-0153_c8719688-b3b7-40ea-b89b-5c7d9a884426 57520-0153 HUMAN OTC DRUG
Testosterone "Testosterone," TABLET ORAL 20100510 20151110
UNAPPROVED HOMEOPATHIC Apothecca Company TESTOSTERONE 30
[hp_X]/5mg
57520-0912_b0cd4eeb-e54c-460d-8966-a56626fb5754 57520-0912 HUMAN OTC DRUG
Lymph Drainage "Citrus limonum, Echinacea, Scrophularia nodosa, Teucriu
m Scorodonia, Baptisia tinctoria, Lobelia inflata, Phytolacca decandra, Pinus sy
lvestris, Zincum gluconicum, Thuja occidentalis, Capsicum annuum," LIQUID
ORAL 20110929 UNAPPROVED HOMEOPATHIC Apothecfa Compan
y "ARANEUS DIADEMATUS; ARSENIC TRIIODIDE; BAPTISIA TINCTORIA ROOT; CAPSICU
M; CARPINUS BETULUS FLOWERING TOP; CENTAURIUM ERYTHRAEA FLOWER; COPPER GLUCONATE
; ECHINACEA, UNSPECIFIED; LACHESIS MUTA VENOM; LARIX DECIDUA FLOWERING TOP; LEMO
N JUICE; LOBELIA INFLATA; MANGANESE GLUCONATE; PHYTOLACCA AMERICANA ROOT; PINUS
SYLVESTRIS FLOWERING TOP; SCROPHULARIA NODOSA; SUS SCROFA LYMPH; SUS SCROFA SPLE
EN; SUS SCROFA THYMUS; TEUCRIUM SCORODONIA FLOWERING TOP; THUJA OCCIDENTALIS LEA
FY TWIG; ZINC GLUCONATE" 8; 8; 1; 6; 8; 8; 6; 1; 12; 8; 1; 3; 6; 3; 3; 1;
57520-0058_86e495bb-fd3a-4e6f-ae87-1521dbf60215 57520-0058 HUMAN PRESCRIPTI
ON DRUG Energize Energize LIQUID ORAL 20100125
UNAPPROVED HOMEOPATHIC Apothica Company "AMERICAN GINSENG; AVENA
SATIVA FLOWERING TOP; GINGER; PHOSPHORIC ACID; POTASSIUM PHOSPHATE, DIBASIC; TR
INITROPHENOL" 6; 3; 3; 6; 12; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/
mL; [hp_X]/mL; [hp_X]/mL "Non-Standardized Plant Allergenic Extract [EPC]
l/Ingredient],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC]"
63323-345_7ea1db43-40fa-417b-8911-ae98092070a0 63323-345 HUMAN PRESCRIPTI
ON DRUG Ceftriaxone Ceftriaxone "INJECTION, POWDER, FOR SOLUTION
29 "APP Pharmaceuticals , LLC" CEFTRIAXONE SODIUM 500 mg/1
29 "APP Pharmaceuticals , LLC" CEFTRIAXONE SODIUM 1 g/1
29 "APP Pharmaceuticals , LLC" CEFTRIAXONE SODIUM 2 g/1
63323-348_8828d4c9-6e71-4d0a-9ca1-bd0d231184ab 63323-348 HUMAN PRESCRIPTI
" INTRAVENOUS 20110620 ANDA ANDA065328 "APP Pha
rmaceuticals , LLC" CEFTRIAXONE SODIUM 10 g/1 "Cephalosporin A
63323-387_0642ef5e-7eff-4117-a0df-4bd15d7b7d63 63323-387 HUMAN PRESCRIPTI
ON DRUG Ampicillin ampicillin sodium "INJECTION, POWDER, FOR
ANDA062719 "APP Pharmaceuticals, Inc." AMPICILLIN SODIUM 250
63323-010_0c997ea4-08ed-418e-8a03-8789541fc781 63323-010 HUMAN PRESCRIPTI
ON DRUG Gentamicin GENTAMICIN SULFATE "INJECTION, SOLUTION"
"APP Pharmaceuticals, LLC" GENTAMICIN SULFATE 40 mg/mL "Aminogl
63323-011_aacc4296-f0b6-4d49-993f-8adbbe53557a 63323-011 HUMAN PRESCRIPTI
ON DRUG Chloramphenicol Sodium Succinate CHLORAMPHENICOL SODIUM S
UCCINATE "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION" INTRAVENOUS
20010112 ANDA ANDA062365 "APP Pharmaceuticals, LLC"
CHLORAMPHENICOL SODIUM SUCCINATE 1 g/10mL "Amphenicol-class Antiba
cterial [EPC],Amphenicols [Chemical/Ingredient]"
63323-012_22cb8823-f453-4469-911e-49e3c92e99ef 63323-012 HUMAN PRESCRIPTI
ON DRUG Oxytocin OXYTOCIN "INJECTION, SOLUTION" INTRAMUS
CULAR; INTRAVENOUS 20000810 NDA NDA018248 "APP Pha
rmaceuticals, LLC" OXYTOCIN 10 [USP'U]/mL "Increased Uteri
ne Smooth Muscle Contraction or Tone [PE],Oxytocic [EPC],Oxytocin [Chemical/Ingr
edient]"
63323-019_ff54b240-853e-4fb6-9b9e-b52404f5f9eb 63323-019 HUMAN PRESCRIPTI
ON DRUG Iodopen Sodium Iodide SODIUM IODIDE "INJECTION, SOLUTION"
INTRAVENOUS 20010718 UNAPPROVED DRUG OTHER "APP Pha
rmaceuticals, LLC" SODIUM IODIDE 118 ug/mL
63323-025_569c6ba5-9a67-4a8c-bf8d-e34f3c473ffd 63323-025 HUMAN PRESCRIPTI
ON DRUG Chorionic Gonadotropin CHORIOGONADOTROPIN ALFA KIT INTRAMUS
CULAR 20110421 NDA NDA017067 "APP Pharmaceuticals, LL
C"
63323-026_c1f99423-2666-4330-9c33-2442402dd6ef 63323-026 HUMAN PRESCRIPTI
ON DRUG Sodium Bicarbonate SODIUM BICARBONATE SOLUTION
INTRAVENOUS 20000810 UNAPPROVED DRUG OTHER "APP Pha
rmaceuticals, LLC" SODIUM BICARBONATE 42 mg/mL
63323-032_9d85c8fe-57f4-4400-b8e3-c66a2826d847 63323-032 HUMAN PRESCRIPTI
ON DRUG Sodium Acetate SODIUM ACETATE "INJECTION, SOLUTION, CONCENTRAT
E" INTRAVENOUS 20000901 UNAPPROVED DRUG OTHER
"APP Pharmaceuticals, LLC" SODIUM ACETATE 328 mg/100mL
63323-044_c024db96-e526-4558-803c-8c22890048d4 63323-044 HUMAN PRESCRIPTI
ON DRUG Cyanocobalamin CYANOCOBALAMIN "INJECTION, SOLUTION" INTRAMUS
CULAR; SUBCUTANEOUS 20001018 ANDA ANDA080557 "APP Pha
rmaceuticals, LLC" CYANOCOBALAMIN 1000 ug/mL "Vitamin B 12 [Chemical/
Ingredient],Vitamin B12 [EPC]"
63323-088_0e109cad-c244-4a63-9c63-ccc7cd6815df 63323-088 HUMAN PRESCRIPTI
OUS 20010112 UNAPPROVED DRUG OTHER "APP Pharmaceuti
cals, LLC" SODIUM CHLORIDE 234 mg/mL
63323-102_1f6640a8-b2c5-4880-88a3-ff5593fef17a 63323-102 HUMAN PRESCRIPTI
ANDA ANDA077983 "APP Pharmaceuticals, LLC" GEMCITABINE HYDROCHLORID
E 200 mg/5mL "Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Meta
bolic Inhibitor [EPC]"
63323-102_7a2275c5-285c-4c2a-8fdc-159353f3d287 63323-102 HUMAN PRESCRIPTI
ON DRUG GEMCITABINE HYDROCHLORIDE GEMCITABINE "INJECTION, POWD
ANDA090799 "APP Pharmaceuticals, LLC" GEMCITABINE HYDROCHLORIDE
200 mg/5mL "Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic In
hibitor [EPC]"
63323-104_f950cc1e-3a2e-4caf-9cc5-6b3579193d82 63323-104 HUMAN PRESCRIPTI
ON DRUG Etoposide ETOPOSIDE "INJECTION, SOLUTION" INTRAVEN
OUS 20010718 ANDA ANDA074983 "APP Pharmaceuticals, LL
C" ETOPOSIDE 20 mg/mL "Topoisomerase Inhibitor [EPC],Topoisome
rase Inhibitors [MoA]"
63323-105_cebdc1fd-5d8e-4c3e-8d41-baa4d28b981f 63323-105 HUMAN PRESCRIPTI
ON DRUG Acyclovir ACYCLOVIR SODIUM "INJECTION, POWDER, LYOP
HILIZED, FOR SOLUTION" INTRAVENOUS 20001017 ANDA ANDA0750
15 "APP Pharmaceuticals, LLC" ACYCLOVIR SODIUM 50 mg/mL
63323-113_2cd3bffe-b3ad-4a79-b782-6880ee48afb0 63323-113 HUMAN PRESCRIPTI
ON DRUG Pentam 300 PENTAMIDINE ISETHIONATE "INJECTION, POWDER, LYOP
HILIZED, FOR SOLUTION" INTRAMUSCULAR; INTRAVENOUS 20010116
NDA NDA019264 "APP Pharmaceuticals, LLC" PENTAMIDINE ISETHIONATE
300 mg/3mL Antiprotozoal [EPC]
63323-117_1de5d9ce-6f14-4672-818d-d85844802c06 63323-117 HUMAN PRESCRIPTI
ON DRUG Fluorouracil FLUOROURACIL "INJECTION, SOLUTION" INTRAVEN
C" FLUOROURACIL 50 mg/mL "Nucleic Acid Synthesis Inhibitors [MoA]
63323-117_e3fd08d5-6bda-46dc-af95-2034601f9209 63323-117 HUMAN PRESCRIPTI
ON DRUG Fluorouracil FLUOROURACIL "INJECTION, SOLUTION" INTRAVEN
C" FLUOROURACIL 50 mg/mL "Nucleic Acid Synthesis Inhibitors [MoA]
63323-120_01e29639-16f7-4f0b-a27c-1e17a4a8184f 63323-120 HUMAN PRESCRIPTI
ON DRUG Cytarabine CYTARABINE "INJECTION, SOLUTION" INTRATHE
CAL; INTRAVENOUS; SUBCUTANEOUS 20041129 ANDA ANDA076512
"APP Pharmaceuticals, LLC" CYTARABINE 100 mg/mL "Nucleic Acid Sy
nthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]"
63323-125_1f6640a8-b2c5-4880-88a3-ff5593fef17a 63323-125 HUMAN PRESCRIPTI
ANDA ANDA077983 "APP Pharmaceuticals, LLC" GEMCITABINE HYDROCHLORID
E 1 g/25mL "Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Meta
bolic Inhibitor [EPC]"
hibitor [EPC]"
hibitor [EPC]"
63323-127_cee49be4-a9e3-4f9f-852e-a3d3b25ac44f 63323-127 HUMAN PRESCRIPTI
ON DRUG Dacarbazine DACARBAZINE "INJECTION, POWDER, FOR SOLUTION
rmaceuticals, LLC" DACARBAZINE 10 mg/mL "Alkylating Activity [Mo
63323-128_cee49be4-a9e3-4f9f-852e-a3d3b25ac44f 63323-128 HUMAN PRESCRIPTI
ON DRUG Dacarbazine DACARBAZINE "INJECTION, POWDER, FOR SOLUTION
rmaceuticals, LLC" DACARBAZINE 10 mg/mL "Alkylating Activity [Mo
63323-129_2c825cab-6f6a-4488-90c8-fed70cd6e4b5 63323-129 HUMAN PRESCRIPTI
ANDA ANDA090088 "APP Pharmaceuticals, LLC" ANASTROZOLE 1
mg/1 "Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA]"
63323-139_08ade467-50c0-4b23-9f39-3fe6333c9e8d 63323-139 HUMAN PRESCRIPTI
ON DRUG Sodium Chloride SODIUM CHLORIDE "INJECTION, SOLUTION" INTRAVEN
OUS 20000906 UNAPPROVED DRUG OTHER "APP Pharmaceuti
cals, LLC" SODIUM CHLORIDE 146 mg/mL
63323-142_85229bdc-0428-4299-b0bc-c9b6576e349f 63323-142 HUMAN PRESCRIPTI
ON DRUG Ifosfamide IFOSFAMIDE "INJECTION, POWDER, LYOPHILIZED,
"APP Pharmaceuticals, LLC" IFOSFAMIDE 1 g/1 "Alkylating Acti
vity [MoA],Alkylating Drug [EPC]"
63323-145_957bd9ea-2646-41d2-bdbd-7ff46f435c4b 63323-145 HUMAN PRESCRIPTI
ON DRUG Floxuridine FLOXURIDINE "INJECTION, POWDER, LYOPHILIZED,
FOR SOLUTION" INTRA-ARTERIAL 20010315 ANDA ANDA075837
"APP Pharmaceuticals, LLC" FLOXURIDINE 500 mg/5mL "Antimetabolite
[EPC],Deoxyuridine [Chemical/Ingredient]"
63323-172_d9188744-e7ac-444a-9c55-6b16e58056a3 63323-172 HUMAN PRESCRIPTI
ON DRUG Carboplatin Carboplatin "INJECTION, SOLUTION" INTRAVEN
C" CARBOPLATIN 10 mg/mL "Platinum-based Drug [EPC],Platinum-cont
aining Compounds [Chemical/Ingredient]"
63323-173_3a8579af-e7a0-419b-a8bc-00e3d59ce5b1 63323-173 HUMAN PRESCRIPTI
ON DRUG Gentamicin GENTAMICIN "INJECTION, SOLUTION" INTRAMUS
CULAR; INTRAVENOUS 20041129 ANDA ANDA062366 "APP Pha
rmaceuticals, LLC" GENTAMICIN SULFATE 10 mg/mL "Aminoglycoside
Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient]"
63323-174_cb3778b6-f8a9-443d-8914-c5a25d22bd36 63323-174 HUMAN PRESCRIPTI
ON DRUG Ifosfamide IFOSFAMIDE "INJECTION, SOLUTION" INTRAVEN
C" IFOSFAMIDE 50 mg/mL "Alkylating Activity [MoA],Alkylating Dr
ug [EPC]"
63323-180_ca892d90-8b34-4ca2-9fc2-26dae433142a 63323-180 HUMAN PRESCRIPTI
ON DRUG Pyridoxine Hydrochloride PYRIDOXINE HYDROCHLORIDE
ANDA ANDA080618 "APP Pharmaceuticals, LLC" PYRIDOXINE HYDROCHLORIDE
100 mg/mL
63323-184_fc0211a8-729b-42af-9fee-8e3f660e3a38 63323-184 HUMAN PRESCRIPTI
ON DRUG Folic Acid Folic Acid "INJECTION, SOLUTION" INTRAMUS
CULAR; INTRAVENOUS; SUBCUTANEOUS 20000905 ANDA ANDA0892
02 "APP Pharmaceuticals, LLC" FOLIC ACID 5 mg/mL
63323-186_3144702a-2e6b-4126-9d63-2cae080777d4 63323-186 HUMAN PRESCRIPTI
ON DRUG Sodium Chloride SODIUM CHLORIDE INJECTION INTRAVENOUS
SODIUM CHLORIDE 9 mg/mL
63323-186_9d0f7f90-ef08-4929-bfb4-c7d1abe7aee1 63323-186 HUMAN PRESCRIPTI
ON DRUG Sodium Chloride SODIUM CHLORIDE INJECTION INTRAMUSCULAR; I
NTRAVENOUS; SUBCUTANEOUS 20000810 UNAPPROVED DRUG OTHER
"APP Pharmaceuticals, LLC" SODIUM CHLORIDE 9 mg/mL
63323-187_fb76dfe1-b526-41fe-99c3-cf8f10a1d41d 63323-187 HUMAN PRESCRIPTI
ON DRUG Sodium Chloride SODIUM CHLORIDE INJECTION INTRAMUSCULAR; I
NTRAVENOUS; SUBCUTANEOUS 20000905 UNAPPROVED DRUG OTHER
"APP Pharmaceuticals, LLC" SODIUM CHLORIDE 234 mg/mL
63323-192_d56d6b53-4f32-494b-ae56-6df241b645e8 63323-192 HUMAN PRESCRIPTI
ON DRUG Fludarabine FLUDARABINE PHOSPHATE "INJECTION, SOLUTION"
INTRAVENOUS 20071116 ANDA ANDA078393 "APP Pharmaceuti
cals, LLC" FLUDARABINE PHOSPHATE 25 mg/mL "Nucleic Acid Synthesis
Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]"
63323-193_ec7062ad-7aa9-47ea-a20f-817aff3025ce 63323-193 HUMAN PRESCRIPTI
ON DRUG Irinotecan Hydrochloride Irinotecan Hydrochloride
"APP Pharmaceuticals, LLC" IRINOTECAN HYDROCHLORIDE 20 mg/mL
"Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA]"
63323-194_44000fed-f3b5-408e-bfdb-8a51ad15b16f 63323-194 HUMAN PRESCRIPTI
ON DRUG Idarubicin Hydrochloride IDARUBICIN HYDROCHLORIDE
40 "APP Pharmaceuticals, LLC" IDARUBICIN HYDROCHLORIDE 1
mg/mL "Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/In
gredient],Topoisomerase Inhibitors [MoA]"
63323-196_f1ffd18c-9f6b-4479-94b9-6890bc730ecc 63323-196 HUMAN PRESCRIPTI
ON DRUG Fludarabine FLUDARABINE PHOSPHATE "INJECTION, POWDER, LYOP
44 "APP Pharmaceuticals, LLC" FLUDARABINE PHOSPHATE 25 mg/mL
"Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]"
63323-201_a40610ac-b8d6-4a75-aeb6-fbea90371b74 63323-201 HUMAN PRESCRIPTI
ON DRUG Lidocaine LIDOCAINE HYDROCHLORIDE "INJECTION, SOLUTION"
INFILTRATION; PERINEURAL 20100527 ANDA ANDA080404
"APP Pharmaceuticals, LLC" LIDOCAINE HYDROCHLORIDE 10 mg/mL "Amide L
esthesia [PE]"
63323-201_cddb2b22-fce3-8967-6e54-dca3df5ac4b3 63323-201 HUMAN PRESCRIPTI
esthesia [PE]"
63323-202_a40610ac-b8d6-4a75-aeb6-fbea90371b74 63323-202 HUMAN PRESCRIPTI
esthesia [PE]"
63323-208_271fc9f2-eb00-49ec-b299-8dbef759344a 63323-208 HUMAN PRESCRIPTI
INTRAVENOUS 20000905 NDA NDA017584 "APP Pharmaceuti
cals, LLC" LIDOCAINE HYDROCHLORIDE 20 mg/mL "Amide Local Anesthetic
[EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE]"
63323-221_a1f3c0e3-d444-4aa8-be67-eee364a2781b 63323-221 HUMAN PRESCRIPTI
ANDA ANDA062663 "APP Pharmaceuticals, LLC" VANCOMYCIN HYDROCHLORIDE
500 mg/10mL "Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingred
ient]"
63323-236_7031149d-ae40-4d77-907f-ee461f36e98e 63323-236 HUMAN PRESCRIPTI
ON DRUG CEFAZOLIN CEFAZOLIN SODIUM "POWDER, FOR SOLUTION"
"APP Pharmaceuticals, LLC" CEFAZOLIN SODIUM 500 mg/2.2mL
63323-237_7031149d-ae40-4d77-907f-ee461f36e98e 63323-237 HUMAN PRESCRIPTI
ON DRUG CEFAZOLIN CEFAZOLIN SODIUM "POWDER, FOR SOLUTION"
"APP Pharmaceuticals, LLC" CEFAZOLIN SODIUM 1 g/3mL "Cephalo
63323-238_47a8928f-708d-418a-829b-36eded96bac0 63323-238 HUMAN PRESCRIPTI
ON DRUG Cefazolin Cefazolin Sodium "POWDER, FOR SOLUTION"
cals, LLC" CEFAZOLIN SODIUM 10 g/1 "Cephalosporin Antibacte
63323-259_728b4d81-03a7-4e2c-809a-50c5bf5a29f2 63323-259 HUMAN PRESCRIPTI
ON DRUG Bacteriostatic Sodium Chloride SODIUM CHLORIDE INJECTION
ED DRUG OTHER "APP Pharmaceuticals, LLC" SODIUM CHLORIDE 9
mg/mL
63323-260_b1469cc4-8c90-836b-a7cd-39f9cc1f63b6 63323-260 HUMAN PRESCRIPTI
ON DRUG Polocaine-MPF MEPIVACAINE HYDROCHLORIDE "INJECTION, SOLU
TION" EPIDURAL; INFILTRATION 20090720 ANDA ANDA089406
"APP Pharmaceuticals, LLC" MEPIVACAINE HYDROCHLORIDE 10 mg/mL
"Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE]
"
63323-268_55057dd7-f616-4919-afab-21a0a5eef69e 63323-268 HUMAN PRESCRIPTI
ON DRUG Scopolamine Hydrobromide SCOPOLAMINE HYDROBROMIDE
UNAPPROVED DRUG OTHER "APP Pharmaceuticals, LLC" SCOPOLAMINE HYDR
OBROMIDE 0.4 mg/mL "Anticholinergic [EPC],Cholinergic Antagonists [
MoA]"
63323-270_454ceeef-5f00-4da6-9236-b17c7bbf656c 63323-270 HUMAN PRESCRIPTI
ON DRUG Propofol PROPOFOL "INJECTION, EMULSION" INTRAVEN
OUS 20091023 NDA NDA019627 "APP Pharmaceuticals, LL
C" PROPOFOL 10 mg/mL "General Anesthesia [PE],General Anesthe
tic [EPC]"
63323-270_702f57e2-fae5-44bf-91e8-e54217c08b41 63323-270 HUMAN PRESCRIPTI
tic [EPC]"
63323-270_ea7567c4-4bf9-58f1-1ccb-65d1a1a8c620 63323-270 HUMAN PRESCRIPTI
tic [EPC]"
63323-272_f8ba014e-aea0-49bc-8345-4e0a384b484e 63323-272 HUMAN PRESCRIPTI
ON DRUG Fluphenazine Decanoate FLUPHENAZINE DECANOATE "INJECTION, SOLU
TION" INTRAMUSCULAR; SUBCUTANEOUS 20101215 ANDA ANDA0714
13 "APP Pharmaceuticals, LLC" FLUPHENAZINE DECANOATE 25 mg/mL
63323-273_b8767d1e-0266-4192-8973-b1eabd0b00bb 63323-273 HUMAN PRESCRIPTI
ON DRUG Sumatriptan Succinate SUMATRIPTAN INJECTION SUBCUTAN
EOUS 20110412 ANDA ANDA079242 "APP Pharmaceuticals, LL
C" SUMATRIPTAN 6 mg/.5mL "Serotonin 1b Receptor Agonists [MoA],Se
rotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonis
t [EPC]"
63323-278_15f6dd30-bd5d-41ad-951e-fa481ed97739 63323-278 HUMAN PRESCRIPTI
ON DRUG Vinblastine Sulfate VINBLASTINE SULFATE INJECTION
cals, LLC" VINBLASTINE SULFATE 1 mg/mL "Vinca Alkaloid [EPC],Vi
nca Alkaloids [Chemical/Ingredient]"
63323-280_060f0f4b-a617-44ab-b38c-9799817ab925 63323-280 HUMAN PRESCRIPTI
ON DRUG Furosemide FUROSEMIDE "INJECTION, SOLUTION" INTRAMUS
CULAR; INTRAVENOUS 20000712 NDA NDA018902 "APP Pha
rmaceuticals, LLC" FUROSEMIDE 10 mg/mL "Increased Diuresis at L
oop of Henle [PE],Loop Diuretic [EPC]"
63323-281_d571f04f-6190-42f2-932c-5a075fd978b9 63323-281 HUMAN PRESCRIPTI
ON DRUG Fluphenazine Hydrochloride FLUPHENAZINE HYDROCHLORIDE
56 "APP Pharmaceuticals, LLC" FLUPHENAZINE HYDROCHLORIDE 2.5
mg/mL "Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient]"
63323-282_b8133f76-8880-4b91-a451-b3f831ad6853 63323-282 HUMAN PRESCRIPTI
ON DRUG Clindamycin CLINDAMYCIN PHOSPHATE "INJECTION, SOLUTION"
"APP Pharmaceuticals, LLC" CLINDAMYCIN PHOSPHATE 150 mg/mL "Decreas
ed Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [C
63323-282_bd1c1648-4733-4233-8337-469fe11bd0cb 63323-282 HUMAN PRESCRIPTI
ON DRUG Clindamycin CLINDAMYCIN PHOSPHATE "INJECTION, SOLUTION"
cals, LLC" CLINDAMYCIN PHOSPHATE 150 mg/mL "Decreased Sebaceous Gla
nd Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredie
nt]"
ON DRUG Polocaine MEPIVACAINE HYDROCHLORIDE "INJECTION, SOLU
TION" INFILTRATION 20090720 ANDA ANDA089407 "APP Pha
rmaceuticals, LLC" MEPIVACAINE HYDROCHLORIDE 10 mg/mL "Amide L
ocal Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE]"
63323-284_a1f3c0e3-d444-4aa8-be67-eee364a2781b 63323-284 HUMAN PRESCRIPTI
ient]"
63323-286_cb8b926d-cf66-bc7e-c940-e820fd4e877c 63323-286 HUMAN PRESCRIPTI
ON DRUG NAROPIN ROPIVACAINE HYDROCHLORIDE MONOHYDRATE "INJECTION, SOLU
TION" EPIDURAL; INFILTRATION; PERINEURAL 20090804 NDA
NDA020533 "APP Pharmaceuticals, LLC" ROPIVACAINE HYDROCHLORIDE MONOHY
DRATE 5 mg/mL "Amide Local Anesthetic [EPC],Amides [Chemical/Ingredien
t],Local Anesthesia [PE]"
63323-289_d0a64e03-fd5e-6a5e-00c4-de687bbf08b3 63323-289 HUMAN PRESCRIPTI
ON DRUG EMLA LIDOCAINE CREAM TOPICAL 20090929
NDA NDA019941 "APP Pharmaceuticals, LLC" LIDOCAINE; PRILOCAINE
25; 25 mg/g; mg/g "Amide Local Anesthetic [EPC],Amides [Chemical/Ingredien
t],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amide
s [Chemical/Ingredient],Local Anesthesia [PE]"
63323-290_d0a64e03-fd5e-6a5e-00c4-de687bbf08b3 63323-290 HUMAN PRESCRIPTI
ON DRUG EMLA LIDOCAINE CREAM TOPICAL 20090929
NDA NDA019941 "APP Pharmaceuticals, LLC" LIDOCAINE; PRILOCAINE
25; 25 mg/g; mg/g "Amide Local Anesthetic [EPC],Amides [Chemical/Ingredien
t],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amide
s [Chemical/Ingredient],Local Anesthesia [PE]"
"
"
63323-295_2b1d6752-c21b-41b9-af18-8e94f809f470 63323-295 HUMAN PRESCRIPTI
ON DRUG Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE
ient]"
ON DRUG Polocaine MEPIVACAINE HYDROCHLORIDE "INJECTION, SOLU
TION" INFILTRATION 20090720 ANDA ANDA089410 "APP Pha
rmaceuticals, LLC" MEPIVACAINE HYDROCHLORIDE 20 mg/mL "Amide L
63323-297_ca4ad961-d984-41bc-bb92-569996f1a17c 63323-297 HUMAN PRESCRIPTI
ON DRUG Propoven PROPOFOL INJECTION INTRAVENOUS
20120701 20150630 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE
"APP Pharmaceuticals, LLC" PROPOFOL 10 mg/mL "General Anesthe
sia [PE],General Anesthetic [EPC]"
63323-300_ba5c4972-44c8-45d1-8f12-48c0a288af4e 63323-300 HUMAN PRESCRIPTI
ON DRUG Piperacillin and Tazobactam "PIPERACILLIN SODIUM,TAZOBACTAM
SODIUM" "INJECTION, POWDER, FOR SOLUTION" INTRAVENOUS 20091013
ANDA ANDA065523 "APP Pharmaceuticals, LLC" PIPERACILLIN SODIUM; TAZ
OBACTAM SODIUM 3; .375 g/15mL; g/15mL "Penicillin-class Antibacterial [EPC],Pe
hibitors [MoA]"
63323-303_be4c8263-e865-44bf-9065-0c20dbaeadf8 63323-303 HUMAN PRESCRIPTI
ON DRUG Tobramycin TOBRAMYCIN SULFATE "INJECTION, POWDER, FOR
SOLUTION" INTRAVENOUS 20051123 NDA NDA050789
"APP Pharmaceuticals, LLC" TOBRAMYCIN SULFATE 1200 mg/30mL "Aminogl
63323-304_44473c11-c305-4094-90cb-11e2526592e5 63323-304 HUMAN PRESCRIPTI
OBACTAM SODIUM 36; 4.5 g/1; g/1 "beta Lactamase Inhibitor [EPC],beta Lac
tamase Inhibitors [MoA]"
hibitors [MoA]"
63323-311_9bd6cde8-0aa2-4e7f-90fb-3118677432ee 63323-311 HUMAN PRESCRIPTI
ON DRUG Calcium Gluconate CALCIUM GLUCONATE "INJECTION, SOLU
"APP Pharmaceuticals, LLC" CALCIUM GLUCONATE 94 mg/mL "Blood C
63323-311_d166384d-8b2d-4d12-9488-3690273de0d4 63323-311 HUMAN PRESCRIPTI
ON DRUG Calcium Gluconate CALCIUM GLUCONATE "INJECTION, SOLU
"APP Pharmaceuticals, LLC" CALCIUM GLUCONATE 94 mg/mL "Blood C
63323-314_2b1d6752-c21b-41b9-af18-8e94f809f470 63323-314 HUMAN PRESCRIPTI
ient]"
63323-315_dafaddc1-cf82-4ef8-922b-981380413d44 63323-315 HUMAN PRESCRIPTI
ON DRUG Ganciclovir GANCICLOVIR SODIUM "INJECTION, POWDER, LYOP
58 "APP Pharmaceuticals, LLC" GANCICLOVIR SODIUM 500 mg/10mL
"Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase
Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Anti
viral [EPC]"
hibitors [MoA]"
63323-321_fbc12c18-567b-41bc-89d0-efd29616615c 63323-321 HUMAN PRESCRIPTI
ON DRUG Polymyxin B POLYMYXIN B SULFATE "INJECTION, POWDER, LYOP
HILIZED, FOR SOLUTION" INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; OPHTHALMIC
POLYMYXIN B SULFATE 500000 [iU]/1 "Polymyxin-class Antibacterial [EPC],Pol
ymyxins [Chemical/Ingredient]"
63323-322_2bb3a14d-313d-4d17-a148-921e33878c1d 63323-322 HUMAN PRESCRIPTI
ON DRUG Imipenem and Cilastatin Imipenem and Cilastatin Sodium "INJECTI
ON, POWDER, FOR SOLUTION" INTRAVENOUS 20120103 ANDA
ANDA090577 "APP Pharmaceuticals, LLC" CILASTATIN SODIUM; IMIPENEM
500; 500 mg/1; mg/1 "Carbapenems [Chemical/Ingredient],Penem Antibac
terial [EPC],Dipeptidase Inhibitors [MoA],Renal Dehydropeptidase Inhibitor [EPC]
"
63323-323_eddf85dc-0839-4d66-a454-dd4990c3c3bd 63323-323 HUMAN PRESCRIPTI
ON DRUG Penicillin G Potassium PENICILLIN G POTASSIUM "POWDER, FOR SOL
UTION" INTRAMUSCULAR; INTRAPLEURAL; INTRATHECAL; INTRAVENOUS 20090901
ANDA ANDA065448 "APP Pharmaceuticals, LLC" PENICILLIN G POTASSIUM
5000000 [iU]/1 "Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingr
edient]"
63323-324_eddf85dc-0839-4d66-a454-dd4990c3c3bd 63323-324 HUMAN PRESCRIPTI
ON DRUG Penicillin G Potassium PENICILLIN G POTASSIUM "POWDER, FOR SOL
UTION" INTRAVENOUS 20090901 ANDA ANDA065448 "APP Pha
rmaceuticals, LLC" PENICILLIN G POTASSIUM 20000000 [iU]/1 "Penicil
63323-325_28a29056-ac13-4e78-a6b4-d713bad2b775 63323-325 HUMAN PRESCRIPTI
ON DRUG Acyclovir ACYCLOVIR SODIUM "INJECTION, POWDER, FOR
"APP Pharmaceuticals, LLC" ACYCLOVIR SODIUM 50 mg/mL "DNA Pol
63323-326_df5d9a1e-4afc-44ce-8231-707df0a2487d 63323-326 HUMAN PRESCRIPTI
ON DRUG Cefepime Cefepime "INJECTION, POWDER, FOR SOLUTION
41 "APP Pharmaceuticals, LLC" CEFEPIME HYDROCHLORIDE 1 g/1
63323-327_ccbd5e0c-26b8-4b5e-8fa9-d104de528775 63323-327 HUMAN PRESCRIPTI
ON DRUG Nafcillin NAFCILLIN SODIUM "POWDER, FOR SOLUTION"
"APP Pharmaceuticals, LLC" NAFCILLIN SODIUM 1 g/4mL "Penicil
63323-328_ccbd5e0c-26b8-4b5e-8fa9-d104de528775 63323-328 HUMAN PRESCRIPTI
ON DRUG Nafcillin NAFCILLIN SODIUM "POWDER, FOR SOLUTION"
"APP Pharmaceuticals, LLC" NAFCILLIN SODIUM 2 g/8mL "Penicil
63323-329_843ce59c-4259-40df-9f9e-ee24b7aa811d 63323-329 HUMAN PRESCRIPTI
ON DRUG Bacitracin BACITRACIN "INJECTION, POWDER, FOR SOLUTION
" INTRAMUSCULAR 20030128 ANDA ANDA065116 "APP Pha
rmaceuticals, LLC" BACITRACIN 50000 [iU]/1 Decreased Cell Wall Synt
hesis & Repair [PE]
63323-330_55cf0341-8568-42b1-9683-2f0b1615a7ae 63323-330 HUMAN PRESCRIPTI
ON DRUG Nafcillin NAFCILLIN "INJECTION, POWDER, FOR SOLUTION
rmaceuticals, LLC" NAFCILLIN SODIUM 10 g/100mL "Penicillin-clas
s Antibacterial [EPC],Penicillins [Chemical/Ingredient]"
63323-338_932d2e24-61a6-4b87-b3cf-d3bf6a53e2db 63323-338 HUMAN PRESCRIPTI
CAPSULE ORAL 20120618 ANDA ANDA065453 "APP Pharmaceuti
cals, LLC" VANCOMYCIN HYDROCHLORIDE 125 mg/1 "Glycopeptide An
tibacterial [EPC],Glycopeptides [Chemical/Ingredient]"
63323-339_932d2e24-61a6-4b87-b3cf-d3bf6a53e2db 63323-339 HUMAN PRESCRIPTI
CAPSULE ORAL 20120618 ANDA ANDA065453 "APP Pharmaceuti
cals, LLC" VANCOMYCIN HYDROCHLORIDE 250 mg/1 "Glycopeptide An
tibacterial [EPC],Glycopeptides [Chemical/Ingredient]"
63323-340_df5d9a1e-4afc-44ce-8231-707df0a2487d 63323-340 HUMAN PRESCRIPTI
ON DRUG Cefepime Cefepime "INJECTION, POWDER, FOR SOLUTION
41 "APP Pharmaceuticals, LLC" CEFEPIME HYDROCHLORIDE 2 g/1
63323-341_d02170ff-65aa-48b8-a922-94271c46ffa7 63323-341 HUMAN PRESCRIPTI
ON DRUG Cefoxitin Cefoxitin Sodium "POWDER, FOR SOLUTION"
cals, LLC" CEFOXITIN SODIUM 1 g/1 "Cephalosporin Antibacte
63323-342_d02170ff-65aa-48b8-a922-94271c46ffa7 63323-342 HUMAN PRESCRIPTI
ON DRUG Cefoxitin Cefoxitin Sodium "POWDER, FOR SOLUTION"
cals, LLC" CEFOXITIN SODIUM 2 g/1 "Cephalosporin Antibacte
63323-343_9f84f170-7202-49a6-b54b-817996de4f8b 63323-343 HUMAN PRESCRIPTI
ON DRUG Cefoxitin Cefoxitin "INJECTION, POWDER, FOR SOLUTION
rmaceuticals, LLC" CEFOXITIN SODIUM 10 g/1 "Cephalosporin A
63323-344_2d85abba-95dc-4d26-bc67-9c45bf4781cb 63323-344 HUMAN PRESCRIPTI
ON DRUG Ceftriaxone CEFTRIAXONE SODIUM "INJECTION, POWDER, FOR
ANDA065245 "APP Pharmaceuticals, LLC" CEFTRIAXONE SODIUM 250
63323-349_2bb3a14d-313d-4d17-a148-921e33878c1d 63323-349 HUMAN PRESCRIPTI
ON DRUG Imipenem and Cilastatin Imipenem and Cilastatin Sodium "INJECTI
ON, POWDER, FOR SOLUTION" INTRAVENOUS 20120103 ANDA
ANDA090577 "APP Pharmaceuticals, LLC" CILASTATIN SODIUM; IMIPENEM
250; 250 mg/1; mg/1 "Carbapenems [Chemical/Ingredient],Penem Antibac
terial [EPC],Dipeptidase Inhibitors [MoA],Renal Dehydropeptidase Inhibitor [EPC]
"
63323-352_c0ae7bae-5a98-4bb5-8f29-153aacacc74f 63323-352 HUMAN PRESCRIPTI
ON DRUG Cefuroxime Cefuroxime "INJECTION, POWDER, FOR SOLUTION
25 "APP Pharmaceuticals, LLC" CEFUROXIME 750 mg/1 "Cephalo
63323-353_c0ae7bae-5a98-4bb5-8f29-153aacacc74f 63323-353 HUMAN PRESCRIPTI
rmaceuticals, LLC" CEFUROXIME 1.5 g/1 "Cephalosporin Antibacte
63323-354_48d601be-4a99-4808-841e-fe48d04f5d9b 63323-354 HUMAN PRESCRIPTI
rmaceuticals, LLC" CEFUROXIME 7.5 g/80mL "Cephalosporin Antibacte
63323-359_33ec208a-0659-415a-9924-3ab35e10fb80 63323-359 HUMAN PRESCRIPTI
ON DRUG Kanamycin KANAMYCIN A SULFATE "INJECTION, SOLUTION"
"APP Pharmaceuticals, LLC" KANAMYCIN A SULFATE 333 mg/mL "Aminogl
63323-366_9de9d0c5-be81-4bc3-b1db-77b248d3ec7c 63323-366 HUMAN PRESCRIPTI
ON DRUG Dimenhydrinate Dimenhydrinate "INJECTION, SOLUTION" INTRAMUS
CULAR; INTRAVENOUS 20041129 ANDA ANDA040519 "APP Pha
rmaceuticals, LLC" DIMENHYDRINATE 50 mg/mL
63323-368_c68d2338-c43e-4a64-8da4-c93873c5a3c8 63323-368 HUMAN PRESCRIPTI
ON DRUG Ampicillin and Sulbactam ampicillin sodium and sulbactam
sodium "INJECTION, POWDER, FOR SOLUTION" INTRAMUSCULAR; INTRAVENOUS
AMPICILLIN SODIUM; SULBACTAM SODIUM 1; .5 g/1; g/1 "Penicillin-clas
s Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor
s [MoA],beta Lactamase Inhibitor [EPC]"
63323-369_c68d2338-c43e-4a64-8da4-c93873c5a3c8 63323-369 HUMAN PRESCRIPTI
sodium "INJECTION, POWDER, FOR SOLUTION" INTRAMUSCULAR; INTRAVENOUS
AMPICILLIN SODIUM; SULBACTAM SODIUM 2; 1 g/1; g/1 "Penicillin-clas
s Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor
s [MoA],beta Lactamase Inhibitor [EPC]"
63323-370_7a7a6041-f76c-4507-bf58-99e119328991 63323-370 HUMAN PRESCRIPTI
sodium "INJECTION, POWDER, FOR SOLUTION" INTRAVENOUS 20061127
ANDA ANDA065314 "APP Pharmaceuticals, LLC" AMPICILLIN SODIUM; SULBA
CTAM SODIUM 10; 5 g/1; g/1 "Penicillin-class Antibacterial [EPC],Pe
nicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase I
nhibitor [EPC]"
63323-385_908f2524-d886-484c-9746-8682878de44e 63323-385 HUMAN PRESCRIPTI
ON DRUG Cefotetan CEFOTETAN DISODIUM "INJECTION, POWDER, FOR
ANDA065374 "APP Pharmaceuticals, LLC" CEFOTETAN DISODIUM 1
g/10mL "Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]"
63323-386_908f2524-d886-484c-9746-8682878de44e 63323-386 HUMAN PRESCRIPTI
ANDA065374 "APP Pharmaceuticals, LLC" CEFOTETAN DISODIUM 2
g/20mL "Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]"
63323-396_86bb9239-35be-466d-bbc4-bed63507ea58 63323-396 HUMAN PRESCRIPTI
"APP Pharmaceuticals, LLC" CEFOTETAN DISODIUM 10 g/1 "Cephalo
63323-404_85bd67e5-386a-4ab8-af66-a2d2adefb54e 63323-404 HUMAN PRESCRIPTI
ON DRUG Ampicillin Ampicillin Sodium "INJECTION, POWDER, FOR
"APP Pharmaceuticals, LLC" AMPICILLIN SODIUM 10 g/1 "Penicil
63323-405_3c5f45ee-b97a-4210-afbe-192b4f8b070b 63323-405 HUMAN PRESCRIPTI
ON DRUG Clonidine Hydrochloride CLONIDINE HYDROCHLORIDE "INJECTION, SOLU
TION" EPIDURAL 20110708 ANDA ANDA200673 "APP Pha
rmaceuticals, LLC" CLONIDINE HYDROCHLORIDE 100 ug/mL "Adrenergic alph
63323-406_6dd6d2eb-1d77-4de6-9d26-9173b4790a41 63323-406 HUMAN PRESCRIPTI
ON DRUG Caffeine Citrate CAFFEINE CITRATE SOLUTION
ORAL 20091119 ANDA ANDA078002 "APP Pharmaceuticals, LL
C" CAFFEINE CITRATE 20 mg/mL "Central Nervous System Stimulan
t [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [
63323-407_aa3a6a78-548a-4de3-a55a-28d381a0371f 63323-407 HUMAN PRESCRIPTI
ON DRUG Caffeine Citrate CAFFEINE CITRATE "INJECTION, SOLU
TION" INTRAVENOUS 20091119 ANDA ANDA077997 "APP Pha
rmaceuticals, LLC" CAFFEINE CITRATE 20 mg/mL "Central Nervous
System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [
EPC],Xanthines [Chemical/Ingredient]"
63323-411_6be45064-2059-4223-9382-832385548419 63323-411 HUMAN PRESCRIPTI
ON DRUG Midazolam MIDAZOLAM HYDROCHLORIDE "INJECTION, SOLUTION"
"APP Pharmaceuticals, LLC" MIDAZOLAM HYDROCHLORIDE 1 mg/mL "Benzodi
azepine [EPC],Benzodiazepines [Chemical/Ingredient]" CIV
63323-412_6be45064-2059-4223-9382-832385548419 63323-412 HUMAN PRESCRIPTI
ON DRUG Midazolam MIDAZOLAM HYDROCHLORIDE "INJECTION, SOLUTION"
"APP Pharmaceuticals, LLC" MIDAZOLAM HYDROCHLORIDE 1 mg/mL "Benzodi
63323-424_09e0dfb2-ed54-4800-9fde-a3b981863db7 63323-424 HUMAN PRESCRIPTI
ON DRUG Flumazenil FLUMAZENIL "INJECTION, SOLUTION" INTRAVEN
C" FLUMAZENIL 0.1 mg/mL Benzodiazepine Antagonist [EPC]
63323-446_65a0b0f7-f729-4e77-9ccd-6a526507b215 63323-446 HUMAN PRESCRIPTI
rmaceuticals, LLC" CEFAZOLIN SODIUM 20 g/100mL "Cephalosporin A
63323-473_263d30a2-d529-406c-aeb2-7547b7aae5ad 63323-473 HUMAN PRESCRIPTI
ON DRUG Sensorcaine MPF BUPIVACAINE HYDROCHLORIDE "INJECTION, SOLU
TION" SUBARACHNOID 20100525 ANDA ANDA071202 "APP Pha
rmaceuticals, LLC" BUPIVACAINE HYDROCHLORIDE 7.5 mg/mL "Amide L
63323-475_69fa64b1-908f-47d8-b4e8-1275f98ddd31 63323-475 HUMAN PRESCRIPTI
ON DRUG Nesacaine CHLOROPROCAINE HYDROCHLORIDE "INJECTION, SOLU
TION" INFILTRATION; PERINEURAL 20101014 NDA NDA00943
5 "APP Pharmaceuticals, LLC" CHLOROPROCAINE HYDROCHLORIDE 10
mg/mL "Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthe
sia [PE]"
ON DRUG Nesacaine CHLOROPROCAINE HYDROCHLORIDE "INJECTION, SOLU
TION" INFILTRATION; PERINEURAL 20101014 NDA NDA00943
5 "APP Pharmaceuticals, LLC" CHLOROPROCAINE HYDROCHLORIDE 20
mg/mL "Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthe
sia [PE]"
ON DRUG Nesacaine MPF CHLOROPROCAINE HYDROCHLORIDE "INJECTION, SOLU
TION" EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20101014
NDA NDA009435 "APP Pharmaceuticals, LLC" CHLOROPROCAINE HYDROCHLO
RIDE 20 mg/mL "Ester Local Anesthetic [EPC],Esters [Chemical/Ingredien
ON DRUG Nesacaine MPF CHLOROPROCAINE HYDROCHLORIDE "INJECTION, SOLU
NDA NDA009435 "APP Pharmaceuticals, LLC" CHLOROPROCAINE HYDROCHLO
RIDE 30 mg/mL "Ester Local Anesthetic [EPC],Esters [Chemical/Ingredien
63323-479_1d66308c-c24e-4016-b432-28da016a3385 63323-479 HUMAN PRESCRIPTI
ON DRUG Xylocaine LIDOCAINE HYDROCHLORIDE JELLY TOPICAL 20100927
NDA NDA008816 "APP Pharmaceuticals, LLC" LIDOCAINE HYDROCHLORIDE
63323-481_903fd0f6-4815-4252-a420-2969aa7ff0b1 63323-481 HUMAN PRESCRIPTI
ON DRUG Xylocaine "LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE"
"INJECTION, SOLUTION" INFILTRATION; PERINEURAL 20100812
NDA NDA006488 "APP Pharmaceuticals, LLC" EPINEPHRINE BITARTRATE;
LIDOCAINE HYDROCHLORIDE .005; 5 mg/mL; mg/mL "Amide Local Anesthetic [EPC],Am
ides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic
alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [E
PC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/I
ngredient]"
ngredient]"
ngredient]"
ON DRUG Xylocaine LIDOCAINE HYDROCHLORIDE "INJECTION, SOLUTION"
INFILTRATION; PERINEURAL 20100812 NDA NDA006488
esthesia [PE]"
esthesia [PE]"
esthesia [PE]"
ON DRUG Xylocaine MPF "LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE"
"INJECTION, SOLUTION" EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20100812
LIDOCAINE HYDROCHLORIDE .005; 10 mg/mL; mg/mL "Amide Local Anesthetic
[EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Ad
renergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Ag
onist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Ch
emical/Ingredient]"
emical/Ingredient]"
emical/Ingredient]"
63323-490_8ec9161c-0ecc-4d29-b31c-fc5a64e6952e 63323-490 HUMAN PRESCRIPTI
ON DRUG Xylocaine-MPF LIDOCAINE HYDROCHLORIDE SOLUTION RETROBUL
BAR; TOPICAL 20091111 NDA NDA010417 "APP Pharmaceuti
ON DRUG Xylocaine MPF LIDOCAINE HYDROCHLORIDE "INJECTION, SOLUTION"
INFILTRATION 20100812 NDA NDA006488 "APP Pharmaceuti
63323-492_89bf9e6e-6233-4133-ba48-e29486aac4a7 63323-492 HUMAN PRESCRIPTI
EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20110718 NDA
NDA006488 "APP Pharmaceuticals, LLC" LIDOCAINE HYDROCHLORIDE 10
mg/mL "Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmi
63323-497_f917ee72-349e-40fa-a602-d7da17fd7ee7 63323-497 HUMAN PRESCRIPTI
ON DRUG Xylocaine LIDOCAINE HYDROCHLORIDE SOLUTION TOPICAL
20091111 NDA NDA010417 "APP Pharmaceuticals, LLC"
LIDOCAINE HYDROCHLORIDE 40 mg/mL "Amide Local Anesthetic [EPC],Amides [Ch
emical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE]"
63323-498_efdd74b1-74b6-4630-a24a-373932e41c05 63323-498 HUMAN PRESCRIPTI
INTRAVENOUS 20091111 NDA NDA016801 "APP Pharmaceuti
63323-506_8a8b8c01-b33a-4d18-b4d9-23408500e03a 63323-506 HUMAN PRESCRIPTI
ON DRUG Dexamethasone Sodium Phosphate DEXAMETHASONE SODIUM PHOSPHATE
ANDA ANDA040491 "APP Pharmaceuticals, LLC" DEXAMETHASONE SODIUM PHO
SPHATE 10 mg/mL "Corticosteroid [EPC],Corticosteroid Hormone Receptor Ag
onists [MoA]"
63323-507_00519448-d0ae-48e5-8921-5ddf5d87601e 63323-507 HUMAN PRESCRIPTI
ON DRUG Meropenem Meropenem "INJECTION, POWDER, FOR SOLUTION
rmaceuticals, LLC" MEROPENEM 500 mg/10mL "Carbapenems [Chemical/I
ngredient],Penem Antibacterial [EPC]"
63323-508_00519448-d0ae-48e5-8921-5ddf5d87601e 63323-508 HUMAN PRESCRIPTI
ON DRUG Meropenem Meropenem "INJECTION, POWDER, FOR SOLUTION
rmaceuticals, LLC" MEROPENEM 1 g/20mL "Carbapenems [Chemical/I
ngredient],Penem Antibacterial [EPC]"
63323-513_c25e8532-f15c-477f-9157-976b8d916a14 63323-513 HUMAN PRESCRIPTI
ON DRUG Gentamicin GENTAMICIN SULFATE "INJECTION, SOLUTION"
"APP Pharmaceuticals, LLC" GENTAMICIN SULFATE 10 mg/mL "Aminogl
63323-516_8a8b8c01-b33a-4d18-b4d9-23408500e03a 63323-516 HUMAN PRESCRIPTI
ON DRUG Dexamethasone Sodium Phosphate DEXAMETHASONE SODIUM PHOSPHATE
ANDA ANDA040572 "APP Pharmaceuticals, LLC" DEXAMETHASONE SODIUM PHO
SPHATE 10 mg/mL "Corticosteroid [EPC],Corticosteroid Hormone Receptor Ag
onists [MoA]"
63323-549_6fee542c-cb91-42e6-94c4-2205b1f95601 63323-549 HUMAN PRESCRIPTI
ON DRUG Heparin Lock Flush HEPARIN SODIUM "INJECTION, SOLUTION"
INTRAVENOUS 20090812 PREMARKET NOTIFICATION K092938 "APP Pha
rmaceuticals, LLC" HEPARIN SODIUM 100 [USP'U]/mL "Anti-coagulant
[EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC]"
63323-557_6fee542c-cb91-42e6-94c4-2205b1f95601 63323-557 HUMAN PRESCRIPTI
ON DRUG Heparin Lock Flush HEPARIN SODIUM "INJECTION, SOLUTION"
INTRAVENOUS 20090829 PREMARKET NOTIFICATION K092938 "APP Pha
rmaceuticals, LLC" HEPARIN SODIUM 10 [USP'U]/mL "Anti-coagulant
[EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC]"
63323-563_ce8c554a-0875-40cb-b3dd-3e34c0ae6a87 63323-563 HUMAN PRESCRIPTI
C" TRANEXAMIC ACID 100 mg/mL "Antifibrinolytic Agent [EPC],Decreased
Fibrinolysis [PE]"
63323-597_85913c5c-c348-4347-bccf-1eb100944ace 63323-597 HUMAN PRESCRIPTI
ON DRUG Deferoxamine DEFEROXAMINE MESYLATE "INJECTION, POWDER, LYOP
HILIZED, FOR SOLUTION" INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20091215
ANDA ANDA078718 "APP Pharmaceuticals, LLC" DEFEROXAMINE MESYLATE
95 mg/mL "Iron Chelating Activity [MoA],Iron Chelator [EPC]"
63323-599_85913c5c-c348-4347-bccf-1eb100944ace 63323-599 HUMAN PRESCRIPTI
ON DRUG Deferoxamine DEFEROXAMINE MESYLATE "INJECTION, POWDER, LYOP
HILIZED, FOR SOLUTION" INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20091215
ANDA ANDA078718 "APP Pharmaceuticals, LLC" DEFEROXAMINE MESYLATE
95 mg/mL "Iron Chelating Activity [MoA],Iron Chelator [EPC]"
63323-604_d571e396-79ee-4c0b-b2d4-641856f006f9 63323-604 HUMAN PRESCRIPTI
ON DRUG Propranolol PROPRANOLOL HYDROCHLORIDE "INJECTION, SOLU
rmaceuticals, LLC" PROPRANOLOL HYDROCHLORIDE 1 mg/mL "Adrener
63323-616_34ce97f0-672a-4588-87a5-d399fb4ff1c4 63323-616 HUMAN PRESCRIPTI
ON DRUG Amiodarone Hydrochloride AMIODARONE HYDROCHLORIDE
61 "APP Pharmaceuticals, LLC" AMIODARONE HYDROCHLORIDE 50
mg/mL "Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotei
n Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhi
bitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA]"
63323-617_7a801fcc-a46c-44b8-b40f-62a681feb80d 63323-617 HUMAN PRESCRIPTI
ON DRUG Milrinone Lactate MILRINONE LACTATE "INJECTION, SOLU
rmaceuticals, LLC" MILRINONE LACTATE 1 mg/mL "Phosphodiestera
se 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA]"
63323-650_b97beb41-3432-42ea-9caf-3a86468f2a04 63323-650 HUMAN PRESCRIPTI
ON DRUG oxaliplatin oxaliplatin "INJECTION, SOLUTION, CONCENTRAT
E" INTRAVENOUS 20100611 ANDA ANDA078811 "APP Pha
rmaceuticals, LLC" OXALIPLATIN 5 mg/mL "Platinum-based Drug [EP
C],Platinum-containing Compounds [Chemical/Ingredient]"
63323-658_de512e9b-444c-4ae4-8c6b-accd87a02021 63323-658 HUMAN PRESCRIPTI
ON DRUG Chlorothiazide CHLOROTHIAZIDE SODIUM "INJECTION, POWDER, LYOP
96 "APP Pharmaceuticals, LLC" CHLOROTHIAZIDE SODIUM 500 mg/18mL
"Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient]
"
63323-664_220d4a75-531f-499d-b5af-3aa846fd2c00 63323-664 HUMAN PRESCRIPTI
ON DRUG Diphenhydramine DIPHENHYDRAMINE HYDROCHLORIDE "INJECTION, SOLU
66 "APP Pharmaceuticals, LLC" DIPHENHYDRAMINE HYDROCHLORIDE 50
mg/mL "Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist
[EPC]"
63323-665_be203fdb-578c-49a1-8a77-b15b80377d75 63323-665 HUMAN PRESCRIPTI
ON DRUG Terbutaline Sulfate TERBUTALINE SULFATE "INJECTION, SOLU
TION" SUBCUTANEOUS 20110310 ANDA ANDA076887 "APP Pha
rmaceuticals, LLC" TERBUTALINE SULFATE 1 mg/mL
63323-710_ec01dcf1-a37a-464d-b6de-a2404e479499 63323-710 HUMAN PRESCRIPTI
ON DRUG Leucovorin Calcium LEUCOVORIN CALCIUM "INJECTION, POWD
ER, LYOPHILIZED, FOR SOLUTION" INTRAMUSCULAR; INTRAVENOUS 20100918
ANDA ANDA040258 "APP Pharmaceuticals, LLC" LEUCOVORIN CALCIUM
200 mg/20mL
63323-711_ec01dcf1-a37a-464d-b6de-a2404e479499 63323-711 HUMAN PRESCRIPTI
ON DRUG Leucovorin Calcium LEUCOVORIN CALCIUM "INJECTION, POWD
ER, LYOPHILIZED, FOR SOLUTION" INTRAMUSCULAR; INTRAVENOUS 20100918
ANDA ANDA040286 "APP Pharmaceuticals, LLC" LEUCOVORIN CALCIUM
500 mg/50mL
63323-733_24e30ae5-dc3c-47c5-af22-8070744f4602 63323-733 HUMAN PRESCRIPTI
ON DRUG Mesna MESNA "INJECTION, SOLUTION" INTRAVENOUS 20010905
ANDA ANDA075811 "APP Pharmaceuticals, LLC" MESNA 100 mg/mL
63323-734_80ed4c20-1e43-4fe2-bfd9-64652ba75471 63323-734 HUMAN PRESCRIPTI
ON DRUG Pamidronate Disodium PAMIDRONATE DISODIUM "INJECTION, SOLU
rmaceuticals, LLC" PAMIDRONATE DISODIUM 3 mg/mL "Bisphosphonate
[EPC],Diphosphonates [Chemical/Ingredient]"
63323-735_80ed4c20-1e43-4fe2-bfd9-64652ba75471 63323-735 HUMAN PRESCRIPTI
ON DRUG Pamidronate Disodium PAMIDRONATE DISODIUM "INJECTION, SOLU
rmaceuticals, LLC" PAMIDRONATE DISODIUM 9 mg/mL "Bisphosphonate
[EPC],Diphosphonates [Chemical/Ingredient]"
63323-738_1664c101-07b5-403a-a357-dd0e5bd13355 63323-738 HUMAN PRESCRIPTI
ON DRUG Famotidine FAMOTIDINE "INJECTION, SOLUTION" INTRAVEN
C" FAMOTIDINE 10 mg/mL "Histamine H2 Receptor Antagonists [MoA]
,Histamine-2 Receptor Antagonist [EPC]"
63323-739_218774bb-b73e-4618-802f-a32ad18d7382 63323-739 HUMAN PRESCRIPTI
ON DRUG Famotidine FAMOTIDINE "INJECTION, SOLUTION" INTRAVEN
C" FAMOTIDINE 10 mg/mL "Histamine H2 Receptor Antagonists [MoA]
,Histamine-2 Receptor Antagonist [EPC]"
63323-762_e86c2a1f-ba1e-44d1-9bd2-b3e88c04f760 63323-762 HUMAN PRESCRIPTI
ON DRUG Topotecan Hydrochloride Topotecan Hydrochloride "INJECTION, POWD
ANDA091376 "APP Pharmaceuticals, LLC" TOPOTECAN HYDROCHLORIDE 4
mg/4mL "Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA]"
63323-763_44bb3dd5-e171-4887-b76c-90b96f8c356f 63323-763 HUMAN PRESCRIPTI
ON DRUG Paclitaxel PACLITAXEL "INJECTION, SOLUTION" INTRAVEN
C" PACLITAXEL 6 mg/mL "Microtubule Inhibition [PE],Microtubule
Inhibitor [EPC]"
63323-772_7e0f6b72-8dd3-4f6d-ad16-80401fb8aba1 63323-772 HUMAN PRESCRIPTI
ON DRUG LETROZOLE LETROZOLE "TABLET, FILM COATED" ORAL
LETROZOLE 2.5 mg/1 "Aromatase Inhibitor [EPC],Aromatase Inhibitors
[MoA]"
63323-877_a74cc23c-ad4e-4a11-b060-1a533f726cd2 63323-877 HUMAN PRESCRIPTI
ON DRUG NebuPent PENTAMIDINE ISETHIONATE INHALANT RESPIRAT
ORY (INHALATION) 20110215 NDA NDA019887 "APP Pha
rmaceuticals, LLC" PENTAMIDINE ISETHIONATE 300 mg/6mL Antiprotozoal [E
PC]
63323-924_53233ea2-a9bb-47b6-8112-644d770db625 63323-924 HUMAN PRESCRIPTI
ON DRUG Bacteriostatic Sodium Chloride SODIUM CHLORIDE INJECTION
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20000808 ANDA
ANDA088911 "APP Pharmaceuticals, LLC" SODIUM CHLORIDE 9 mg/mL
63323-963_34b48ae3-745a-4491-80eb-4d90961d2d35 63323-963 HUMAN PRESCRIPTI
ON DRUG Acetylcysteine Acetylcysteine "INJECTION, SOLUTION" INTRAVEN
C" ACETYLCYSTEINE 200 mg/mL "Antidote [EPC],Antidote for Acetaminoph
63323-965_904c7604-8bbc-4f22-a923-38c1513ba80a 63323-965 HUMAN PRESCRIPTI
ON DRUG Potassium Chloride POTASSIUM CHLORIDE "INJECTION, SOLU
TION, CONCENTRATE" INTRAVENOUS 19990927 ANDA ANDA0889
01 "APP Pharmaceuticals, LLC" POTASSIUM CHLORIDE 2 meq/mL
63323-967_904c7604-8bbc-4f22-a923-38c1513ba80a 63323-967 HUMAN PRESCRIPTI
ON DRUG Potassium Chloride POTASSIUM CHLORIDE "INJECTION, SOLU
TION, CONCENTRATE" INTRAVENOUS 20000905 ANDA ANDA0889
08 "APP Pharmaceuticals, LLC" POTASSIUM CHLORIDE 2 meq/mL
60207-001_c89ffcbb-ad69-42a5-87c7-eec980be394b 60207-001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS "Apple Homecare Associates, Inc." OXYGEN
99 L/100L
67147-221_6e737375-cf4a-4271-b222-3c350a1542f7 67147-221 HUMAN OTC DRUG
Hanitizer ALCOHOL GEL TOPICAL 20101001 OTC MONO
GRAPH NOT FINAL part333E "Apple Products, Inc." ALCOHOL 0.7 mL/mL
67147-544_19520d37-fd12-4727-a056-a82e5df86d36 67147-544 HUMAN OTC DRUG
Pro-Care CHLOROXYLENOL SOAP TOPICAL 20100901
OTC MONOGRAPH NOT FINAL part333E "Apple Products, Inc." CHLOROXYLENOL
0.003 mL/mL
67147-576_668fb3b4-2658-45ec-a01c-aef3caa51813 67147-576 HUMAN OTC DRUG
DermaCare TRICLOSAN SOAP TOPICAL 20100701
OTC MONOGRAPH NOT FINAL part333E "Apple Products, Inc." TRICLOSAN
0.003 mL/mL
67147-585_b8a35dcd-dba7-46d8-91f7-79c09b97eb87 67147-585 HUMAN OTC DRUG
Al CaFoam ALCOHOL LIQUID TOPICAL 20101201 OTC MONO
67147-855_be49866d-0c0b-463a-8ba3-a1c684e44588 67147-855 HUMAN OTC DRUG
Al CaFoam ALCOHOL LIQUID TOPICAL 20101201 OTC MONO
54841-001_67755d0f-9e46-4d57-b631-18b587bc2846 54841-001 HUMAN OTC DRUG
Photocil Dimethicone CREAM TOPICAL 20140301
OTC MONOGRAPH FINAL part347 Applied Biology DIMETHICONE 0.07 g/7g
54841-001_7807ce1f-742e-4b37-91f3-910c8d847ae8 54841-001 HUMAN OTC DRUG
54841-001_7f20dc95-4ac5-4c21-8187-f8fe47f6fe66 54841-001 HUMAN OTC DRUG
55071-001_0299d45c-b5e7-4391-bf59-b98ec0ace84d 55071-001 HUMAN OTC DRUG
SUN SAVVY SOLAR SHIELD SPF 20 ZINC OXIDE TITANIUM DIOXIDE LOTION TOPICAL
20110326 OTC MONOGRAPH NOT FINAL part352 APPLIED SKIN TECHNOLOGY
LLC TITANIUM DIOXIDE; ZINC OXIDE 5; 5 g/100mL; g/100mL
58914-170_f47cc79f-d18e-4395-8189-7645bf572741 58914-170 HUMAN PRESCRIPTI
ON DRUG Carafate Sucralfate SUSPENSION ORAL 19931216
NDA NDA019183 Aptalis Pharma Inc. SUCRALFATE 1 g/10mL
"Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient]"
58914-003_c13faff9-fc01-462e-b931-d1b2d16936a6 58914-003 HUMAN PRESCRIPTI
ON DRUG ULTRESA Pancrelipase "CAPSULE, DELAYED RELEASE" ORAL
20120301 NDA NDA022222 "Aptalis Pharma US, Inc"
PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE 27600; 1
3800; 27600 [USP'U]/1; [USP'U]/1; [USP'U]/1
3000; 46000 [USP'U]/1; [USP'U]/1; [USP'U]/1
0700; 41400 [USP'U]/1; [USP'U]/1; [USP'U]/1
58914-112_120dc05b-dfe5-464d-95e0-7c006078f856 58914-112 HUMAN PRESCRIPTI
ON DRUG Viokace Pancrelipase TABLET ORAL 20120301
NDA NDA022542 "Aptalis Pharma US, Inc" PANCRELIPASE AMYLASE; PA
NCRELIPASE LIPASE; PANCRELIPASE PROTEASE 39150; 10440; 39150 [USP'U]/
1; [USP'U]/1; [USP'U]/1
58914-117_120dc05b-dfe5-464d-95e0-7c006078f856 58914-117 HUMAN PRESCRIPTI
ON DRUG Viokace Pancrelipase TABLET ORAL 20120301
NDA NDA022542 "Aptalis Pharma US, Inc" PANCRELIPASE AMYLASE; PA
NCRELIPASE LIPASE; PANCRELIPASE PROTEASE 78300; 20880; 78300 [USP'U]/
1; [USP'U]/1; [USP'U]/1
42865-100_17d9e921-c135-46a8-8a38-b31dde8d5508 42865-100 HUMAN PRESCRIPTI
ON DRUG ZENPEP pancrelipase "CAPSULE, DELAYED RELEASE" ORAL
20090922 NDA NDA022210 "Aptalis Pharma US, Inc."
000; 17000 [USP'U]/1; [USP'U]/1; [USP'U]/1
0000; 34000 [USP'U]/1; [USP'U]/1; [USP'U]/1
5000; 51000 [USP'U]/1; [USP'U]/1; [USP'U]/1
PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE 109000;
20000; 68000 [USP'U]/1; [USP'U]/1; [USP'U]/1
000; 10000 [USP'U]/1; [USP'U]/1; [USP'U]/1
PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE 136000;
25000; 85000 [USP'U]/1; [USP'U]/1; [USP'U]/1
58914-012_1429a692-c49b-456c-9202-9a666041c916 58914-012 HUMAN PRESCRIPTI
ON DRUG Bentyl Dicyclomine hydrochloride CAPSULE ORAL 19500511
NDA NDA007409 "Aptalis Pharma US, Inc." DICYCLOMINE HYDROCHLORID
E 10 mg/1 "Anticholinergic [EPC],Cholinergic Antagonists [MoA]"
ON DRUG Bentyl Dicyclomine hydrochloride TABLET ORAL 19500511
NDA NDA007409 "Aptalis Pharma US, Inc." DICYCLOMINE HYDROCHLORID
E 20.6 mg/1 "Anticholinergic [EPC],Cholinergic Antagonists [MoA]"
ON DRUG Bentyl Dicyclomine hydrochloride "INJECTION, SOLUTION"
INTRAMUSCULAR 19520813 NDA NDA008370 "Aptalis Pharma
US, Inc." DICYCLOMINE HYDROCHLORIDE 20 mg/2mL "Anticholinergic
58914-171_96119ecc-c980-45b0-9272-1646042d2a5a 58914-171 HUMAN PRESCRIPTI
ON DRUG Carafate Sucralfate TABLET ORAL 19811030
NDA NDA018333 "Aptalis Pharma US, Inc." SUCRALFATE 1
g/1 "Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient]"
58914-301_c8c91ddf-0bb5-4172-a533-e35a97305dda 58914-301 HUMAN PRESCRIPTI
ON DRUG Rectiv nitroglycerin OINTMENT RECTAL 20110621
NDA NDA021359 "Aptalis Pharma US, Inc." NITROGLYCERIN 4
mg/g "Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [
PE]"
58914-501_4fd91f27-1189-4193-828e-2336cc60a729 58914-501 HUMAN PRESCRIPTI
ON DRUG CANASA Mesalamine SUPPOSITORY RECTAL 20010105
NDA NDA021252 "Aptalis Pharma US, Inc." MESALAMINE 1000
mg/1 "Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient]"
58914-600_937f6e5f-5c9d-4f4f-9a35-caaeb5e3b9c1 58914-600 HUMAN PRESCRIPTI
ON DRUG Pylera "Bismuth subcitrate potassium, Metronidazole, Tetracycli
ne hydrochloride" CAPSULE ORAL 20070501 20150228 NDA
NDA050786 "Aptalis Pharma US, Inc." BISMUTH SUBCITRATE POTASSIUM; ME
TRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE 140; 125; 125 mg/1; mg/1; mg/1
"Bismuth [Chemical/Ingredient],Bismuth [EPC],Nitroimidazole Antimicrobial [EPC],
Nitroimidazoles [Chemical/Ingredient],Tetracycline-class Antimicrobial [EPC],Tet
racyclines [Chemical/Ingredient]"
58914-601_937f6e5f-5c9d-4f4f-9a35-caaeb5e3b9c1 58914-601 HUMAN PRESCRIPTI
ON DRUG Pylera "Bismuth subcitrate potassium, Metronidazole, Tetracycli
ne hydrochloride" CAPSULE ORAL 20130801 NDA NDA05078
6 "Aptalis Pharma US, Inc." BISMUTH SUBCITRATE POTASSIUM; METRONIDAZ
OLE; TETRACYCLINE HYDROCHLORIDE 140; 125; 125 mg/1; mg/1; mg/1 "Bismuth
[Chemical/Ingredient],Bismuth [EPC],Nitroimidazole Antimicrobial [EPC],Nitroimi
dazoles [Chemical/Ingredient],Tetracycline-class Antimicrobial [EPC],Tetracyclin
58914-785_6f988c2c-e19d-41a7-9d13-80252a28873e 58914-785 HUMAN PRESCRIPTI
ON DRUG Urso 250 Ursodiol "TABLET, FILM COATED" ORAL
URSODIOL 250 mg/1 "Bile Acid [EPC],Bile Acids and Salts [Chemical/
Ingredient]"
58914-790_6f988c2c-e19d-41a7-9d13-80252a28873e 58914-790 HUMAN PRESCRIPTI
ON DRUG Urso Forte Ursodiol "TABLET, FILM COATED" ORAL
URSODIOL 500 mg/1 "Bile Acid [EPC],Bile Acids and Salts [Chemical/
Ingredient]"
76281-301_658d8d06-b4b9-49a5-9f32-d5a22033bc59 76281-301 HUMAN OTC DRUG
Childrens Allergy Relief DIPHENHYDRAMINE HYDROCHLORIDE LIQUID
ORAL 20130821 OTC MONOGRAPH FINAL part341 AptaPharma Inc.
76281-302_0fa300f5-d15a-4ad7-874e-d4a0bc6a1b94 76281-302 HUMAN OTC DRUG
Childrens Pain and Fever ACETAMINOPHEN LIQUID ORAL 20130821
OTC MONOGRAPH NOT FINAL part343 AptaPharma Inc. ACETAMINOPHEN 160 mg/5mL
16110-026_becbd930-ea5f-11e3-ac10-0800200c9a66 16110-026 HUMAN PRESCRIPTI
ON DRUG Cordran flurandrenolide OINTMENT TOPICAL 19651018
NDA NDA012806 Aqua Pharmaceuticals FLURANDRENOLIDE 0.5 mg/g
16110-035_becbd930-ea5f-11e3-ac10-0800200c9a66 16110-035 HUMAN PRESCRIPTI
ON DRUG Cordran flurandrenolide CREAM TOPICAL 19651018
NDA NDA012806 Aqua Pharmaceuticals FLURANDRENOLIDE 0.5 mg/g
16110-052_fca8e801-018a-11e4-9191-0800200c9a66 16110-052 HUMAN PRESCRIPTI
ON DRUG Cordran flurandrenolide LOTION TOPICAL 19630319
NDA NDA013790 Aqua Pharmaceuticals FLURANDRENOLIDE 0.5 mg/mL
16110-111_64c13476-1af5-11e3-a19b-0800200c9a66 16110-111 HUMAN PRESCRIPTI
ON DRUG Verdeso desonide "AEROSOL, FOAM" TOPICAL 20061006
NDA NDA021978 Aqua Pharmaceuticals DESONIDE 0.5 mg/g
16110-501_50efb530-1430-11e4-8c21-0800200c9a66 16110-501 HUMAN PRESCRIPTI
ON DRUG Acticlate doxycycline hyclate "TABLET, COATED"
ORAL 20140728 NDA NDA205931 Aqua Pharmaceuticals
16110-502_50efb530-1430-11e4-8c21-0800200c9a66 16110-502 HUMAN PRESCRIPTI
ON DRUG Acticlate doxycycline hyclate "TABLET, COATED"
ORAL 20140728 NDA NDA205931 Aqua Pharmaceuticals
16110-075_801944a0-d797-11e3-9c1a-0800200c9a66 16110-075 HUMAN PRESCRIPTI
ON DRUG Monodox doxycycline CAPSULE ORAL 20070131
NDA NDA050641 "Aqua Pharmaceuticals, LLC" DOXYCYCLINE 75
mg/1
mg/1
mg/1
16110-812_2262f565-8046-41b1-a62c-aac3ef2de03d 16110-812 HUMAN PRESCRIPTI
ON DRUG Fluoroplex fluorouracil CREAM TOPICAL 19931203
NDA NDA016988 "Aqua Pharmaceuticals, LLC" FLUOROURACIL 10
mg/g "Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor
[EPC]"
16110-080_a7348eef-8cf0-4cb6-a402-3bfd33feed75 16110-080 HUMAN PRESCRIPTI
ON DRUG Xolegel ketoconazole GEL TOPICAL 20060728
NDA NDA021946 "Aqua Pharmaceuticals, LLC." KETOCONAZOLE 20
mg/g "Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4
[MoA]"
58399-1001_2fd4e561-efc9-4704-81a6-3f98069e7f45 58399-1001 HUMAN OTC DRUG
Aquapick Whitening Bubblepick SODIUM FLUORIDE LIQUID DENTAL 20130502
OTC MONOGRAPH FINAL part355 "Aquapick Co., Ltd" SODIUM FLUORIDE 0.001
mg/mL
66273-0001_357f1627-0281-4a30-be09-9ae2933be6d8 66273-0001 HUMAN OTC DRUG
EXENCE WHITE HYDROQUINONE CREAM CUTANEOUS 20110712
OTC MONOGRAPH NOT FINAL part358A AQUIMPEX SPA HYDROQUINONE 4
mL/200mL
66273-0002_f8f3f653-d438-47d5-a846-918652369467 66273-0002 HUMAN OTC DRUG
EXENCE WHITE HYDROQUINONE LOTION CUTANEOUS 20110712
mL/200mL
66273-0003_aed6d52b-47fb-4d19-8c4d-c81e20d104f7 66273-0003 HUMAN OTC DRUG
CLEAR ACTION HYDROQUINONE CREAM CUTANEOUS 20110719
mL/500mL
66273-0004_f8ccdf5e-20ce-490a-bb5c-be34b30444e4 66273-0004 HUMAN OTC DRUG
CLEAR ACTION HYDROQUINONE LOTION CUTANEOUS 20110719
mL/500mL
64778-0213_a017c276-267f-4ff3-84eb-83113b94ff65 64778-0213 HUMAN PRESCRIPTI
ON DRUG Denti-Care Denti-Pro Topical Sodium Fluoride 60 Second Sodium F
luoride GEL DENTAL 19991201 UNAPPROVED DRUG OTHER
AR Medicom Inc SODIUM FLUORIDE 0.0272 g/mL
64778-0214_2ec74fc5-58bc-462c-879e-653c36825968 64778-0214 HUMAN PRESCRIPTI
64778-0215_a148e480-6f09-41f3-9b81-595dd68c047b 64778-0215 HUMAN PRESCRIPTI
64778-0216_e2b60289-478e-4d88-bb80-f63471e31412 64778-0216 HUMAN PRESCRIPTI
64778-0217_90ea26cc-60a2-403a-853e-6db936166aff 64778-0217 HUMAN PRESCRIPTI
64778-0218_84631a8e-2f4e-43d1-88bb-e2faa5045695 64778-0218 HUMAN PRESCRIPTI
64778-0219_a1399c85-a5b1-490f-b38e-f15e0d579742 64778-0219 HUMAN PRESCRIPTI
64778-0236_3aacdc81-ac3a-459a-97e5-0203d030c424 64778-0236 HUMAN PRESCRIPTI
ON DRUG DentiCare Denti-Pro Sodium Fluoride GEL DENTAL 19991103
UNAPPROVED DRUG OTHER AR Medicom Inc SODIUM FLUORIDE 0.02 g/mL
64778-0373_e7161ee2-a6e2-4828-a80a-6046f0666b94 64778-0373 HUMAN PRESCRIPTI
ON DRUG Denti-Care Denti-Foam Topical Sodium Fluoride Bubble Gum Sodium F
luoride "AEROSOL, FOAM" DENTAL 20030501 UNAPPROVED DRUG OTHER
AR Medicom Inc SODIUM FLUORIDE 0.0272 g/g
64778-0375_22878d8b-2e74-41e6-9c8c-5b8e7441b1a7 64778-0375 HUMAN PRESCRIPTI
ON DRUG Denti-Care Denti-Foam Topical Sodium Fluoride Grape Sodium Fluoride
"AEROSOL, FOAM" DENTAL 20030401 UNAPPROVED DRUG OTHER
64778-0376_1104c26b-ae7d-475c-8bd8-3331d4bc122c 64778-0376 HUMAN PRESCRIPTI
ON DRUG Denti-Care Denti-Foam Topical Sodium Fluoride Mint Sodium Fluoride
64778-0377_8aa88ec0-4973-4cd4-a529-c93f6b1a2524 64778-0377 HUMAN PRESCRIPTI
ON DRUG Denti-Care Denti-Foam Topical Sodium Fluoride Orange Sodium Fluoride
64778-0378_e1e2a3f0-1849-4d43-b9f0-d573f5c44081 64778-0378 HUMAN PRESCRIPTI
ON DRUG Denti-Care Denti-Foam Topical Sodium Fluoride Raspberry Sodium F
64778-0379_a3de89d7-7071-4a3f-89e8-f780ef617529 64778-0379 HUMAN PRESCRIPTI
ON DRUG Denti-Care Denti-Foam Topical Sodium Fluoride Strawberry Sodium F
64778-0393_ff82566a-906a-4c3d-b5fa-7f22193733b9 64778-0393 HUMAN PRESCRIPTI
ON DRUG Denti-Care Denti-Freeze Topical Anesthetic Bubblegum "benzocaine, tet
racaine hydrochloride" GEL DENTAL 20000201 UNAPPROVED DRUG
OTHER AR Medicom Inc BENZOCAINE; TETRACAINE HYDROCHLORIDE .18; .02
g/g; g/g "Standardized Chemical Allergen [EPC],Increased Histamine Releas
e [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Ester Local A
nesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE]"
64778-0394_0debe0b5-a32d-4206-808c-f4a5ce648612 64778-0394 HUMAN PRESCRIPTI
ON DRUG Denti-Care Denti-Freeze Topical Anesthetic Cherry "benzocaine, tet
64778-0396_641e77b9-a7d6-4715-84d6-b21e7c14fa60 64778-0396 HUMAN PRESCRIPTI
ON DRUG Denti-Care Denti-Freeze Topical Anesthetic Mint "benzocaine, tetracaine
hydrochloride" GEL DENTAL 20000201 UNAPPROVED DRUG OTHER
AR Medicom Inc BENZOCAINE; TETRACAINE HYDROCHLORIDE .18; .02 g/g; g/g
"Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-medi
ated Immunity [PE],Allergens [Chemical/Ingredient],Ester Local Anesthetic [EPC],
Esters [Chemical/Ingredient],Local Anesthesia [PE]"
64778-0398_9109b9d5-693a-4983-aa2c-6fd951434767 64778-0398 HUMAN PRESCRIPTI
ON DRUG Denti-Care Denti-Freeze Topical Anesthetic Raspberry "benzocaine, tet
64778-0399_4776a475-535d-4bcf-b7d6-eb1d68094bd2 64778-0399 HUMAN PRESCRIPTI
ON DRUG Denti-Care Denti-Freeze Topical Anesthetic Strawberry "benzocaine, tet
64778-0446_0091301e-6476-40e3-b2c0-91d1117e922f 64778-0446 HUMAN PRESCRIPTI
ON DRUG Denti-Care Denti-Rinse Neutral Sodium Fluoride Oral Rinse Sodium F
luoride LIQUID DENTAL 20010301 UNAPPROVED DRUG OTHER
64778-0448_6504d1c4-47ed-492d-adef-be9e5ca48868 64778-0448 HUMAN PRESCRIPTI
ON DRUG Denti-Care Denti-Rinse Neutral Sodium Fluoride Oral Rinse Berry
Sodium Fluoride LIQUID DENTAL 20010601 UNAPPROVED DRUG OTHER
64778-0493_59ca3bac-a5c5-4b23-a748-a75eb657c29b 64778-0493 HUMAN PRESCRIPTI
ON DRUG Denti-Care Denti-Freeze Topical Anesthetic Bubblegum benzocaine
OINTMENT DENTAL 20050728 UNAPPROVED DRUG OTHER
AR Medicom Inc BENZOCAINE 0.2 g/mL "Standardized Chemical Allergen
[EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Ch
emical/Ingredient]"
64778-0494_d146d72c-01b8-46ce-a578-1015a6e54c6e 64778-0494 HUMAN PRESCRIPTI
ON DRUG Denti-Care Denti-Freeze Topical Anesthetic Cherry benzocaine
emical/Ingredient]"
64778-0496_c67827c0-1d9c-4824-aeda-e30f4976c3d0 64778-0496 HUMAN PRESCRIPTI
ON DRUG Denti-Care Denti-Freeze Topical Anesthetic Mint benzocaine OINTMENT
DENTAL 20050728 UNAPPROVED DRUG OTHER AR Medicom Inc
BENZOCAINE 0.2 g/mL "Standardized Chemical Allergen [EPC],Increased
Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredien
t]"
64778-0498_c329a057-f165-44c9-a0f8-adb29269b9d7 64778-0498 HUMAN PRESCRIPTI
ON DRUG Denti-Care Denti-Freeze Topical Anesthetic Raspberry benzocaine
emical/Ingredient]"
64778-0499_fca653cb-59c6-47e9-bb50-11e60da686ac 64778-0499 HUMAN PRESCRIPTI
ON DRUG Denti-Care Denti-Freeze Topical Anesthetic Strawberry benzocaine
emical/Ingredient]"
64778-1212_765dd81a-0b10-4707-8d48-f044202b96c3 64778-1212 HUMAN PRESCRIPTI
ON DRUG DentiCare Pro-Gel Sodium Fluoride GEL DENTAL 20050401
64778-1213_e9ca9521-00df-4cb2-b26c-1962f17ce6bf 64778-1213 HUMAN PRESCRIPTI
64778-1231_8c47c049-4b10-4b7b-836c-12229c6ee059 64778-1231 HUMAN PRESCRIPTI
64778-1232_d026177c-467e-4c93-b356-9f39d3c17b71 64778-1232 HUMAN PRESCRIPTI
64778-1233_66546f71-3ac0-4da0-b293-a6fbd20af855 64778-1233 HUMAN PRESCRIPTI
64778-1371_93fca716-8acf-4403-a674-76729d45135a 64778-1371 HUMAN PRESCRIPTI
ON DRUG DentiCare Pro-Foam Sodium Fluoride "AEROSOL, FOAM" DENTAL
20030501 UNAPPROVED DRUG OTHER AR Medicom Inc SODIUM F
LUORIDE 0.0272 g/g
64778-1372_49a40936-2fe8-4510-93e2-c22f1c04daea 64778-1372 HUMAN PRESCRIPTI
ON DRUG DentiCare Pro-Foam Sodium Fluoride "AEROSOL, FOAM" DENTAL
20030501 UNAPPROVED DRUG OTHER AR Medicom Inc SODIUM F
LUORIDE 0.0272 g/g
64778-1373_a24a83eb-3f91-496a-b78a-95b5a0b3db76 64778-1373 HUMAN PRESCRIPTI
ON DRUG Denti-Care Topical Fluoride Foam Bubble Gum Fluoride Ions
AR Medicom Inc HYDROFLUORIC ACID; SODIUM FLUORIDE .01; .0176 g/g; g/g
64778-1375_ab845c6e-6c51-46fa-914a-4f2420863f53 64778-1375 HUMAN PRESCRIPTI
ON DRUG Denti-Care Topical Fluoride Foam Grape Fluoride Ions "AEROSOL
, FOAM" DENTAL 20030501 UNAPPROVED DRUG OTHER AR Medic
om Inc HYDROFLUORIC ACID; SODIUM FLUORIDE .01; .0176 g/g; g/g
64778-1377_caee8eb8-3571-4e9f-80cc-2efdec2ad091 64778-1377 HUMAN PRESCRIPTI
ON DRUG Denti-Care Topical Fluoride Foam Orange Fluoride Ions "AEROSOL
64778-1378_0ef082fc-d68a-432b-adbf-dc67a578f3ad 64778-1378 HUMAN PRESCRIPTI
ON DRUG Denti-Care Topical Fluoride Foam Raspberry Fluoride Ions "AEROSOL
64778-1379_3a3abc74-46e5-46d2-8d17-f47284902078 64778-1379 HUMAN PRESCRIPTI
ON DRUG Denti-Care Topical Sodium Fluoride Strawberry Sodium Fluoride
AR Medicom Inc HYDROFLUORIC ACID; SODIUM FLUORIDE .01; .0176 g/g; g/g
64778-1443_094d714e-d8f2-4622-87d0-d23b1671c703 64778-1443 HUMAN PRESCRIPTI
ON DRUG DentiCare Pro-Rinse Sodium Fluoride RINSE DENTAL 20010601
64778-0244_b2b081f6-f148-46dc-915e-6b1cd0f8dae7 64778-0244 HUMAN PRESCRIPTI
ON DRUG Denti-Care Denti-Rinse Chlorhexidine Gluconate Oral Rinse Chlorhex
idine Gluconante LIQUID DENTAL 20060602 ANDA ANDA0777
89 AR Medicom Inc. CHLORHEXIDINE GLUCONATE 0.12 g/mL Decreased Cell W
all Integrity [PE]
13310-119_d6eb54b7-2050-4449-85b8-1592cec62176 13310-119 HUMAN PRESCRIPTI
ON DRUG Colcrys Colchicine "TABLET, FILM COATED" ORAL 20090901
NDA NDA022352 AR Scientific Inc. COLCHICINE 0.6 mg/1
"Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA]"
13310-153_d2f8943c-0442-4ddc-a712-5c1c79fed29b 13310-153 HUMAN PRESCRIPTI
ON DRUG Qualaquin Quinine Sulfate CAPSULE ORAL 20050812
NDA NDA021799 AR Scientific Inc. QUININE SULFATE 324 mg/1
Antimalarial [EPC]
13310-101_26bcf80c-8314-4e10-b32c-452dbce94f7a 13310-101 HUMAN PRESCRIPTI
ON DRUG FIBRICOR Fenofibric Acid TABLET ORAL 20090814
NDA NDA022418 "AR Scientific, Inc." FENOFIBRIC ACID 35 mg/1
Peroxisome Proliferator Receptor alpha Agonist [EPC]
13310-102_26bcf80c-8314-4e10-b32c-452dbce94f7a 13310-102 HUMAN PRESCRIPTI
ON DRUG FIBRICOR Fenofibric Acid TABLET ORAL 20090814
NDA NDA022418 "AR Scientific, Inc." FENOFIBRIC ACID 105 mg/1
Peroxisome Proliferator Receptor alpha Agonist [EPC]
13310-145_e4750422-45bb-4e1b-9a27-17d31bb588b2 13310-145 HUMAN PRESCRIPTI
ON DRUG Bactrim Sulfamethoxazole and Trimethoprim TABLET ORAL
20041101 NDA NDA017377 "AR Scientific, Inc." SULFAMET
HOXAZOLE; TRIMETHOPRIM 400; 80 mg/1; mg/1 "Sulfonamide Antimicrobial [EPC]
,Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydro
folate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitor
s [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibi
tors [MoA]"
13310-146_e4750422-45bb-4e1b-9a27-17d31bb588b2 13310-146 HUMAN PRESCRIPTI
ON DRUG Bactrim DS Sulfamethoxazole and Trimethoprim TABLET
ORAL 20041101 NDA NDA017377 "AR Scientific, Inc."
SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 "Sulfonamide Ant
imicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibito
rs [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Red
uctase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Tran
sporter 2 Inhibitors [MoA]"
42472-720_c23eb632-a3b9-49ff-b78a-f74c05bfc046 42472-720 HUMAN OTC DRUG
ARAMIS LAB SERIES POWER PROTECTOR SPF 50 "OCTISALATE, HOMOSALATE, AVOBENZ
ONE, OXYBENZONE" LOTION TOPICAL 20091201 OTC MONOGRAPH NO
T FINAL part352 ARAMIS INC AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE
3; 5; 5; 3 1/100mL; mL/100mL; mL/100mL; mL/100mL
42472-001_fe5bfddb-4c84-45d1-a48c-8e1d92961fab 42472-001 HUMAN OTC DRUG
24 HOUR ANTIPERSPIRANT NATURAL ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY
SPRAY TOPICAL 19791001 OTC MONOGRAPH FINAL part350 ARAMIS I
NC. ALUMINUM CHLOROHYDREX PROPYLENE GLYCOL 10 mL/100mL
42472-002_dc74ce6c-6e92-429b-846d-df428433dd2c 42472-002 HUMAN OTC DRUG
LAB SERIES SKINCARE FOR MEN BB TINTED MOISTURIZER BROAD SPECTRUM SPF 35
"OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, and ZINC OXIDE" LIQUID
TOPICAL 20110424 OTC MONOGRAPH NOT FINAL part352 Aramis Inc.
OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE 7.4; 4;
2.5; 2.2; 2 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL
42472-695_57aa4879-7e8d-46bc-a98f-0cb422f0df24 42472-695 HUMAN OTC DRUG
24 HOUR HIGH PERFORMANCE ANTIPERSPIRANT ALUMINUM ZIRCONIUM TETRACHLOROHY
part350 ARAMIS INC. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.6
mL/100mL
42472-887_0cc49c82-b0d8-4ae9-8985-028826430374 42472-887 HUMAN OTC DRUG
LAB SERIES SKINCARE FOR MEN DAILY MOISTURE DEFENSE BROAD SPECTRUM SPF 15
"AVOBENZONE, OCTINOXATE, and OCTISALATE" LOTION TOPICAL 20050101
OTC MONOGRAPH NOT FINAL part352 ARAMIS INC. AVOBENZONE; OCTINOXATE; OCTISALA
TE .0212; .0795; .0318 g/100mL; g/100mL; g/100mL
42508-137_a28eba54-866b-432b-833e-6f7e89c4444d 42508-137 HUMAN OTC DRUG
Arbonne Revelage Age Spot Brightening Hand Therapy with SPF 30 "HOMOSAL
ATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, and OXYBENZONE" LOTION TOPICAL
20100803 OTC MONOGRAPH NOT FINAL part352 "Arbonne International,
LLC" HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 80; 75;
50; 30; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL
42508-138_9a8aa9b5-3edf-4a41-b315-101c329b6093 42508-138 HUMAN OTC DRUG
Arbonne Revelage Age Spot Brightening Day with SPF 30 "Avobenzone, Hom
osalate, Octinoxate, Octisalate, Octocrylene, and Oxybenzone" LOTION TOPICAL
20100120 OTC MONOGRAPH NOT FINAL part352 "Arbonne International,
LLC" AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
30; 100; 35; 50; 27.9; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL
42508-139_1eeec454-e348-4de8-835c-8df37d0db327 42508-139 HUMAN OTC DRUG
RE9 Advanced Restorative Day Creme SPF 20 "OCTISALATE, OCTOCRYLENE, and ZI
NC OXIDE" LOTION TOPICAL 20100121 OTC MONOGRAPH NOT FINAL
part352 "Arbonne International, LLC" OCTISALATE; OCTOCRYLENE; ZINC OXIDE
50; 80; 73.5 mg/mL; mg/mL; mg/mL
42508-145_044d3f59-e234-45b0-aa5d-716533af7609 42508-145 HUMAN OTC DRUG
Sheer Finish Tinted Moisturizer Light SPF 15 Zinc Oxide EMULSION
TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 "Arbonne Interna
tional, LLC" ZINC OXIDE 10 g/100mL
42508-146_428f87bd-94d1-4d3b-afb6-2650f3a02834 42508-146 HUMAN OTC DRUG
Sheer Finish Tinted Moisturizer Medium SPF 15 Zinc Oxide EMULSION
42508-147_9df65088-23d4-45a7-af89-ad1e34fb4018 42508-147 HUMAN OTC DRUG
Sheer Finish Tinted Moisturizer Medium-Beige SPF 15 Zinc Oxide EMULSION
42508-148_ad9de237-6b7e-4d52-b833-80f0b9bca710 42508-148 HUMAN OTC DRUG
Sheer Finish Tinted Moisturizer Fair SPF 15 Zinc Oxide EMULSION
42508-149_fff38745-b006-4554-8715-a65c0279d910 42508-149 HUMAN OTC DRUG
Sheer Finish Tinted Moisturizer Dark SPF 15 Zinc Oxide EMULSION
42508-150_2d54fd42-f702-432c-bd81-ad679b453a0d 42508-150 HUMAN OTC DRUG
Sheer Finish Tinted Moisturizer Warm Beige SPF 15 Zinc Oxide EMULSION
42508-151_4fdfbd9e-1204-4e7a-922b-9168bb687c8a 42508-151 HUMAN OTC DRUG
Perfecting Liquid Foundation Deep Bronze SPF 15 Zinc Oxide EMULSION
42508-152_76fd79f7-c1d4-46e2-9834-8a5ed1a48d97 42508-152 HUMAN OTC DRUG
Perfecting Liquid Foundation Earthy Beige SPF 15 Zinc Oxide EMULSION
42508-153_2ba06cde-6ff3-4651-956e-705071af7236 42508-153 HUMAN OTC DRUG
Perfecting Liquid Foundation Alabaster SPF 15 Zinc Oxide EMULSION
42508-154_ea5a2d13-ca8e-4745-a4a2-ec64855825a2 42508-154 HUMAN OTC DRUG
Perfecting Liquid Foundation Fair SPF 15 Zinc Oxide EMULSION
42508-155_412dcf8b-164d-4f6c-b90c-9ea8a9d50920 42508-155 HUMAN OTC DRUG
Perfecting Liquid Foundation Golden Beige SPF 15 Zinc Oxide EMULSION
42508-156_fb8ea753-e98b-4b8b-83c8-845f4f923832 42508-156 HUMAN OTC DRUG
Perfecting Liquid Foundation Golden Bronze SPF 15 Zinc Oxide EMULSION
42508-157_fd4d62e7-6038-4f10-ba5b-3c5f6372f584 42508-157 HUMAN OTC DRUG
Perfecting Liquid Foundation Honey Beige SPF 15 Zinc Oxide EMULSION
42508-158_bd588828-8b17-4440-8fba-e8a97403164c 42508-158 HUMAN OTC DRUG
Perfecting Liquid Foundation Rosy Beige SPF 15 Zinc Oxide EMULSION
42508-159_c817c04a-6077-45a4-8a38-3aa1f4143eb1 42508-159 HUMAN OTC DRUG
Perfecting Liquid Foundation Neutral Beige SPF 15 Zinc Oxide EMULSION
42508-160_dda286e8-8e92-4455-99cc-3a5065db461d 42508-160 HUMAN OTC DRUG
Perfecting Liquid Foundation Soft Blush SPF 15 Zinc Oxide EMULSION
42508-161_fdea415f-f840-461f-9b17-532cc5eac515 42508-161 HUMAN OTC DRUG
Perfecting Liquid Foundation Toffee Bronze SPF 15 Zinc Oxide EMULSION
42508-162_a34804e7-949a-4aba-92f1-032490251267 42508-162 HUMAN OTC DRUG
Perfecting Liquid Foundation Deep Beige SPF 15 Zinc Oxide EMULSION
42508-163_ea6a62fc-3e30-4a5d-a6c9-9b82c3866680 42508-163 HUMAN OTC DRUG
Perfecting Liquid Foundation Espresso SPF 15 Zinc Oxide EMULSION
42508-164_455a4579-59cd-4bc1-bee8-5e0e270451bf 42508-164 HUMAN OTC DRUG
Perfecting Liquid Foundation Porcelain SPF 15 Zinc Oxide EMULSION
42508-165_c18eeca9-a0bc-4587-a57a-655805adebb9 42508-165 HUMAN OTC DRUG
Perfecting Liquid Foundation Buff SPF 15 Zinc Oxide EMULSION
42508-254_b33923a0-7a5c-4bb1-a5b0-d8515c192851 42508-254 HUMAN OTC DRUG
Clear Advantage Clarifying SALICYLIC ACID LOTION TOPICAL 20090306
OTC MONOGRAPH FINAL part333D "Arbonne International, LLC" SALICYLI
C ACID 10 mg/mL
42508-255_3d7b79b6-f30a-4cf5-8d7c-7404e62a6b55 42508-255 HUMAN OTC DRUG
Clear Advantage Clarifying Wash SALICYLIC ACID SOLUTION TOPICAL 20090316
C ACID 10 mg/mL
42508-256_a7a8c8bc-d6df-4e9f-b9ab-3856a014e6b5 42508-256 HUMAN OTC DRUG
Arbonne Clear Advantage Toner Salicylic Acid LOTION TOPICAL 20090401
C ACID 5 mg/mL
42508-263_d599b368-7f3f-4025-bb27-bb05522a4e2d 42508-263 HUMAN OTC DRUG
Arbonne Baby Care Sunscreen SPF 30 "OCTINOXATE, OCTISALATE, OXYBENZ
ONE, and ZINC OXIDE" CREAM TOPICAL 20100801 OTC MONOGRAPH NO
T FINAL part352 "Arbonne International, LLC" OCTINOXATE; OCTISALATE; OXYBENZO
NE; ZINC OXIDE 75; 50; 25; 100 mg/mL; mg/mL; mg/mL; mg/mL
42508-265_3acdfdb1-fd03-4cfb-8c36-2c1e880ead57 42508-265 HUMAN OTC DRUG
Arbonne RE9 Advanced for Men Facial Moisturizer SPF 20 "Octisalate, Oct
ocrylene, and Zinc Oxide" LOTION TOPICAL 20100501 OTC MONO
GRAPH NOT FINAL part352 "Arbonne International, LLC" OCTISALATE; OCTOCRYLENE;
ZINC OXIDE 50; 80; 73.5 mg/mL; mg/mL; mg/mL
42508-280_192d2bf0-ee5e-46cd-a0cc-bf8b5ac6436f 42508-280 HUMAN OTC DRUG
Arbonne Made in the Shade Self Tanner Sunscreen SPF 15 "OCTINOXATE, OCT
ISALATE, and OXYBENZONE" LOTION TOPICAL 20110606 OTC MONO
GRAPH NOT FINAL part352 "Arbonne International, LLC" OCTINOXATE; OCTISALATE;
OXYBENZONE 75; 50; 30 mg/mL; mg/mL; mg/mL
12948-001_f7f9b55d-95f7-45e0-8afc-33a3065017e3 12948-001 HUMAN PRESCRIPTI
ON DRUG BiDil Hydralazine hydrochloride and Isosorbide dinitrate
Arbor Pharmaceuticals HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE 37.5; 20
mg/1; mg/1 "Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC],Nitra
te Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE]"
24338-050_75e9afc4-26dc-4939-9f64-51bbeee1de3b 24338-050 HUMAN PRESCRIPTI
ON DRUG Gliadel carmustine WAFER INTRACAVITARY 20121213
NDA NDA020637 Arbor Pharmaceuticals CARMUSTINE 7.7 mg/1
24338-200_287cc0f1-6111-44db-8657-525a62a4397c 24338-200 HUMAN PRESCRIPTI
ON DRUG Nymalize nimodipine SOLUTION ORAL 20130603
NDA NDA203340 Arbor Pharmaceuticals NIMODIPINE 60 mg/20mL
"Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC]
,Dihydropyridines [Chemical/Ingredient]"
24338-416_39d22315-b861-402b-a50e-f5da6a3d75dd 24338-416 HUMAN PRESCRIPTI
ON DRUG Triamcinolone Acetonide Triamcinolone Acetonide CREAM TOPICAL
19971126 ANDA ANDA040039 Arbor Pharmaceuticals Inc.
TRIAMCINOLONE ACETONIDE 1 mg/g
24338-516_d09c0079-fa57-43fc-bba1-b9846920ac94 24338-516 HUMAN PRESCRIPTI
ON DRUG Nystatin Nystatin CREAM TOPICAL 19930128
ANDA ANDA064022 Arbor Pharmaceuticals Inc. NYSTATIN 100000
60631-040_13ea2d5f-a13b-4cc5-aa17-4e44b12ca15c 60631-040 HUMAN PRESCRIPTI
ON DRUG Edarbi Azilsartan kamedoxomil TABLET ORAL 20130201
NDA NDA200796 Arbor Pharmaceuticals Ireland Limited AZILSARTAN KAMED
OXOMIL 40 mg/1 "Angiotensin 2 Type 1 Receptor Antagonists [MoA],Angiote
nsin 2 Receptor Blocker [EPC],Decreased Blood Pressure [PE]"
60631-080_13ea2d5f-a13b-4cc5-aa17-4e44b12ca15c 60631-080 HUMAN PRESCRIPTI
ON DRUG Edarbi Azilsartan kamedoxomil TABLET ORAL 20130201
NDA NDA200796 Arbor Pharmaceuticals Ireland Limited AZILSARTAN KAMED
OXOMIL 80 mg/1 "Angiotensin 2 Type 1 Receptor Antagonists [MoA],Angiote
nsin 2 Receptor Blocker [EPC],Decreased Blood Pressure [PE]"
60631-412_c341db04-8c98-4595-aee6-bbb2d7d646a6 60631-412 HUMAN PRESCRIPTI
ON DRUG Edarbyclor Azilsartan kamedoxomil and chlorthalidone
TABLET ORAL 20130201 NDA NDA202331 Arbor Pharmaceut
icals Ireland Limited AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE 40; 12.5
mg/1; mg/1 "Angiotensin 2 Type 1 Receptor Antagonists [MoA],Angiotensin 2 R
eceptor Blocker [EPC],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thia
zide-like Diuretic [EPC]"
60631-425_c341db04-8c98-4595-aee6-bbb2d7d646a6 60631-425 HUMAN PRESCRIPTI
ON DRUG Edarbyclor Azilsartan kamedoxomil and chlorthalidone
TABLET ORAL 20130201 NDA NDA202331 Arbor Pharmaceut
icals Ireland Limited AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE 40; 25 mg/1; mg
/1 "Angiotensin 2 Type 1 Receptor Antagonists [MoA],Angiotensin 2 Receptor
Blocker [EPC],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide-lik
e Diuretic [EPC]"
24338-010_c1639413-d804-4fe5-963d-fa7c4bd63225 24338-010 HUMAN PRESCRIPTI
ON DRUG BiDil Hydralazine hydrochloride and Isosorbide dinitrate
"Arbor Pharmaceuticals, Inc." HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE
37.5; 20 mg/1; mg/1 "Arteriolar Vasodilation [PE],Arteriolar Vasodil
ator [EPC],Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation
[PE]"
24338-100_78691a80-a6cc-450a-a077-7bfa57ff4002 24338-100 HUMAN PRESCRIPTI
ON DRUG E.E.S 400 Erythromycin Ethylsuccinate TABLET ORAL 20110503
ANDA ANDA061905 "Arbor Pharmaceuticals, Inc." ERYTHROMYCIN ETHYLSUCCIN
ATE 400 mg/1 "Decreased Sebaceous Gland Activity [PE],Macrolide [EPC]
,Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]"
24338-102_72334fa3-04c6-4bee-a3d9-15a14bffafaf 24338-102 HUMAN PRESCRIPTI
ON DRUG Erythromycin Erythromycin "TABLET, FILM COATED" ORAL
20110906 ANDA ANDA061621 "Arbor Pharmaceuticals, Inc."
ERYTHROMYCIN 250 mg/1 "Decreased Sebaceous Gland Activity [PE],Macroli
de [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]"
24338-104_72334fa3-04c6-4bee-a3d9-15a14bffafaf 24338-104 HUMAN PRESCRIPTI
ON DRUG Erythromycin Erythromycin "TABLET, FILM COATED" ORAL
24338-106_97723f64-0615-402a-9c48-593ab5a9d5ec 24338-106 HUMAN PRESCRIPTI
ON DRUG Erythrocin Stearate ERYTHROMYCIN STEARATE "TABLET, FILM CO
ATED" ORAL 20110801 ANDA ANDA060359 "Arbor Pharmaceu
ticals, Inc." ERYTHROMYCIN STEARATE 250 mg/1 "Decreased Sebaceous Gla
nd Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemi
cal/Ingredient]"
24338-110_caa1bc9f-962a-409e-8d3f-83115259b1c3 24338-110 HUMAN PRESCRIPTI
ON DRUG ERYTHROMYCIN ETHYLSUCCINATE Erythromycin Ethylsuccinate
TABLET ORAL 20111003 ANDA ANDA061904 "Arbor Pharmaceu
ticals, Inc." ERYTHROMYCIN ETHYLSUCCINATE 400 mg/1 "Decreased Sebac
eous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolide
24338-112_2742a78f-022f-4c97-be6f-f97c4a7c4527 24338-112 HUMAN PRESCRIPTI
ON DRUG PCE ERYTHROMYCIN ETHYLSUCCINATE TABLET ORAL 20111005
NDA NDA050611 "Arbor Pharmaceuticals, Inc." ERYTHROMYCIN ETHYLSUCCIN
24338-114_2742a78f-022f-4c97-be6f-f97c4a7c4527 24338-114 HUMAN PRESCRIPTI
ON DRUG PCE ERYTHROMYCIN ETHYLSUCCINATE TABLET ORAL 20111005
NDA NDA050611 "Arbor Pharmaceuticals, Inc." ERYTHROMYCIN ETHYLSUCCIN
24338-120_98e41f94-ac95-40e6-b7f5-39dc5e696a9a 24338-120 HUMAN PRESCRIPTI
ON DRUG ERYTHROMYCIN Erythromycin "CAPSULE, DELAYED RELEASE"
ORAL 20120110 ANDA ANDA062746 "Arbor Pharmaceuticals,
Inc." ERYTHROMYCIN 250 mg/1 "Decreased Sebaceous Gland Activity [PE]
24338-122_05c654d8-f2f0-4a50-8369-336d70946d15 24338-122 HUMAN PRESCRIPTI
ON DRUG ERY-TAB Erythromycin "TABLET, DELAYED RELEASE" ORAL
24338-130_97846f49-4484-46c0-9093-ceaaa1a81cc8 24338-130 HUMAN PRESCRIPTI
ON DRUG Ery-Ped Erythromycin Ethylsuccinate SUSPENSION ORAL
20120614 NDA NDA050207 "Arbor Pharmaceuticals, Inc."
ERYTHROMYCIN ETHYLSUCCINATE 400 mg/5mL "Decreased Sebaceous Gland Activ
ity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingr
edient]"
24338-132_97846f49-4484-46c0-9093-ceaaa1a81cc8 24338-132 HUMAN PRESCRIPTI
ON DRUG Ery-Ped Erythromycin Ethylsuccinate SUSPENSION ORAL
20110705 NDA NDA050207 "Arbor Pharmaceuticals, Inc."
ERYTHROMYCIN ETHYLSUCCINATE 200 mg/5mL "Decreased Sebaceous Gland Activ
ity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingr
edient]"
ON DRUG E.E.S Erythromycin Ethylsuccinate "GRANULE, FOR SUSPENSION
" ORAL 20110418 NDA NDA050207 "Arbor Pharmaceu
ticals, Inc." ERYTHROMYCIN ETHYLSUCCINATE 200 mg/5mL "Decreased Sebac
" ORAL 20110418 NDA NDA050207 "Arbor Pharmaceu
ticals, Inc." ERYTHROMYCIN ETHYLSUCCINATE 200 mg/5mL "Decreased Sebac
24338-300_1f0668f8-7308-4304-92fd-1154f6d448a9 24338-300 HUMAN PRESCRIPTI
ON DRUG Nitrolingual Pumpspray nitroglycerin "SPRAY, METERED"
ORAL 20000201 NDA NDA018705 "Arbor Pharmaceuticals,
Inc." NITROGLYCERIN 400 ug/1 "Nitrate Vasodilator [EPC],Nitrates [Che
24338-320_d78ca693-f071-4cc1-896a-7c1805c3e3d5 24338-320 HUMAN PRESCRIPTI
ON DRUG Pediaderm AF Nystatin KIT 20110101
ANDA ANDA062364 "Arbor Pharmaceuticals, Inc."
24338-420_64938885-cae4-417b-bb34-3aadd8e0e3c4 24338-420 HUMAN PRESCRIPTI
ON DRUG Pediaderm HC Hydrocortisone KIT 20091102
24338-430_6c8f74e8-91c7-4670-8034-a57cb6ea8985 24338-430 HUMAN PRESCRIPTI
ON DRUG Pediaderm TA Triamcinolone Acetonide CREAM TOPICAL 20100901
ANDA ANDA040039 "Arbor Pharmaceuticals, Inc." TRIAMCINOLONE ACETONIDE
1 mg/g "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [
MoA]"
24338-520_cde49b4a-7d7e-49b8-8d93-51b7c917055b 24338-520 HUMAN PRESCRIPTI
ON DRUG Pediaderm TA Triamcinolone Acetonide KIT 20110101
24338-602_935d5be5-4713-4114-8c99-a50c953b1fee 24338-602 HUMAN PRESCRIPTI
ON DRUG Fluor-a-day Sodium fluoride and Xylitol "TABLET, CHEWABL
E" ORAL 20100815 UNAPPROVED DRUG OTHER "Arbor P
harmaceuticals, Inc." SODIUM FLUORIDE; XYLITOL .25; 236.79 mg/1; mg
/1
harmaceuticals, Inc." SODIUM FLUORIDE; XYLITOL .5; 236.79 mg/1; mg
/1
harmaceuticals, Inc." SODIUM FLUORIDE; XYLITOL 1; 236.79 mg/1; mg
/1
ON DRUG Fluor-a-day Sodium fluoride SOLUTION/ DROPS ORAL 20100815
UNAPPROVED DRUG OTHER "Arbor Pharmaceuticals, Inc." SODIUM FLUORIDE
5.56 mg/mL
24338-850_8b325d7c-65a0-41fa-9773-6fb5dcde7ab8 24338-850 HUMAN PRESCRIPTI
ON DRUG Zenzedi Dextroamphetamine Sulfate TABLET ORAL 20130531
ANDA ANDA090533 "Arbor Pharmaceuticals, Inc." DEXTROAMPHETAMINE SULFAT
E 2.5 mg/1 "Central Nervous System Stimulant [EPC],Central Nervous
System Stimulation [PE]" CII
E 5 mg/1 "Central Nervous System Stimulant [EPC],Central Nervous
E 7.5 mg/1 "Central Nervous System Stimulant [EPC],Central Nervous
59788-001_ed740912-5603-4e7e-830b-a002a9ca67fb 59788-001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS Arcet Equipment Company OXYGEN 995 mL/L
59788-002_6a6f02fd-14a8-42c9-b7b2-664fa5b099ee 59788-002 HUMAN PRESCRIPTI
20070115 UNAPPROVED MEDICAL GAS Arcet Equipment Company
NITROGEN 990 mL/L
51772-311_ec21fe5a-b1f8-405e-9d75-6c01a24c9e51 51772-311 HUMAN PRESCRIPTI
ON DRUG LAZANDA Fentanyl Citrate SPRAY NASAL 20111017
NDA NDA022569 Archimedes Pharma US Inc. FENTANYL CITRATE
100 ug/1 "Full Opioid Agonists [MoA],Opioid Agonist [EPC]" CII
51772-314_ec21fe5a-b1f8-405e-9d75-6c01a24c9e51 51772-314 HUMAN PRESCRIPTI
ON DRUG LAZANDA Fentanyl Citrate SPRAY NASAL 20111017
NDA NDA022569 Archimedes Pharma US Inc. FENTANYL CITRATE
400 ug/1 "Full Opioid Agonists [MoA],Opioid Agonist [EPC]" CII
65722-0123_908a0fae-3e15-4ed6-8a43-b479111741ec 65722-0123 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS Aretsia Medical Supply OXYGEN 99 L/100L
59923-601_dce13f87-2c75-75f3-606f-acd7fe2e93cf 59923-601 HUMAN PRESCRIPTI
ON DRUG Pamidronate Disodium Pamidronate Disodium "INJECTION, POWD
ANDA077433 Areva Pharmaceuticals Inc. PAMIDRONATE DISODIUM 3
mg/mL "Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient]"
59923-701_58e873dd-811e-43dd-8c4b-d39848ba2df0 59923-701 HUMAN PRESCRIPTI
"Areva Pharmaceuticals,Inc." EPIRUBICIN HYDROCHLORIDE 2 mg/mL
59923-702_8232464d-4799-47fa-b6c5-ceaff1924b3c 59923-702 HUMAN PRESCRIPTI
ON DRUG Irinotecan Hydrochloride Irinotecan INJECTION
INTRAVENOUS 20120716 ANDA ANDA077219 "Areva Pharmaceu
ticals,Inc." IRINOTECAN HYDROCHLORIDE 20 mg/mL "Topoisomerase I
nhibitor [EPC],Topoisomerase Inhibitors [MoA]"
44397-001_dcd523d1-de78-4dd7-91b7-8a6d8fcb8732 44397-001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS Argyle Welding Supply Co. Inc. OXYGEN 99
L/100L
44397-010_f3211ed5-af40-4037-85bb-a3ddceed4257 44397-010 HUMAN PRESCRIPTI
19740101 UNAPPROVED MEDICAL GAS Argyle Welding Supply Co
. Inc. NITROUS OXIDE 99 L/100L
44397-020_2ad3a940-2916-494c-8e9f-187916626074 44397-020 HUMAN PRESCRIPTI
19740101 UNAPPROVED MEDICAL GAS Argyle Welding Supply Co
. Inc. NITROGEN 99 L/100L
76189-534_2cbc4b0d-0f41-424d-95e4-9515f1f0a834 76189-534 HUMAN PRESCRIPTI
ON DRUG Iclusig ponatinib hydrochloride "TABLET, FILM COATED" ORAL
20121214 NDA NDA203469 "ARIAD Pharmaceuticals, Inc."
PONATINIB HYDROCHLORIDE 45 mg/1 "Kinase Inhibitor [EPC],Protein Kinase I
nhibitors [MoA]"
76189-535_2cbc4b0d-0f41-424d-95e4-9515f1f0a834 76189-535 HUMAN PRESCRIPTI
ON DRUG Iclusig ponatinib hydrochloride "TABLET, FILM COATED" ORAL
20121214 NDA NDA203469 "ARIAD Pharmaceuticals, Inc."
PONATINIB HYDROCHLORIDE 15 mg/1 "Kinase Inhibitor [EPC],Protein Kinase I
nhibitors [MoA]"
24486-200_c55797d4-27ee-4735-b25e-fc2704931ef9 24486-200 HUMAN PRESCRIPTI
ON DRUG Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release
Hydrocodone Polistirex and Chlorpheniramine Polistirex "SUSPENSION, EXTENDED RE
LEASE" ORAL 20120629 ANDA ANDA091671 "Aristos Phamace
uticals, Inc." CHLORPHENIRAMINE; HYDROCODONE 8; 10 mg/5mL; mg/5mL "Opioid
Agonist [EPC],Opioid Agonists [MoA],Histamine H1 Receptor Antagonists [MoA],Hist
amine-1 Receptor Antagonist [EPC]" CIII
61300-0001_381b38b5-bfeb-4c2a-b402-bcaa8a2fb5e6 61300-0001 HUMAN OTC DRUG
MAX "Abrotanum (Artemisia abrotanum), Anacardium orientale, Baryta m
uriatica, Calcarea carbonica, Calcarea phosphorica, Fucus vesiculosus, Graphites
, Helleborus niger," SPRAY ORAL 20140430 UNAPPROVED HOMEO
PATHIC "Arize Supplements, LLC" "ARTEMISIA ABROTANUM FLOWERING T
OP; BARIUM CHLORIDE DIHYDRATE; CLAVICEPS PURPUREA SCLEROTIUM; FUCUS VESICULOSUS;
GRAPHITE; HELLEBORUS NIGER ROOT; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE
, DIBASIC TRIHYDRATE; MELATONIN; NIACINAMIDE; ONION; OYSTER SHELL CALCIUM CARBON
ATE, CRUDE; PORK LIVER; SEMECARPUS ANACARDIUM JUICE; SEROTONIN HYDROCHLORIDE; SI
LICON DIOXIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS IGNATII SEED; SUS SCR
OFA ADRENAL GLAND; SUS SCROFA HYPOTHALAMUS; SUS SCROFA OVARY; SUS SCROFA PANCREA
S; SUS SCROFA TESTICLE; SUS SCROFA THYROID; THIAMINE HYDROCHLORIDE; THYMOL; TRIB
ASIC CALCIUM PHOSPHATE" 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 12; 8; 8
p_X]/mL
63218-4000_ecdf1c1a-2824-40c6-8645-9a59e64ee10b 63218-4000 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS "Arizona Respiratory & Medical Supply Services,
Inc." OXYGEN 99 L/100L
52428-001_4e17c42c-6bb9-40e2-b2bd-04ab33852518 52428-001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS Arkansas Home Medical OXYGEN 99 L/100L
65603-001_8af37b23-a407-4af8-888a-edfffe195015 65603-001 HUMAN OTC DRUG
Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20011020
UNAPPROVED MEDICAL GAS Arkansas Welding & Industrial Supply OXYGEN
992 mL/L
10849-001_dc30e569-a551-401a-86c2-f58ba4c00ec1 10849-001 HUMAN OTC DRUG
Terapie Callus Remover SALICYLIC ACID LIQUID TOPICAL 20111104
OTC MONOGRAPH FINAL part358F Armand Dupree SALICYLIC ACID 17
mL/100mL
10849-003_d2b292f5-845d-4a86-ab71-ff14e10f3bd0 10849-003 HUMAN OTC DRUG
Acne Off Acne Treatment SALICYLIC ACID GEL TOPICAL 20120419
OTC MONOGRAPH FINAL part333D Armand Dupree SALICYLIC ACID 20
g/100g
10849-004_585fe53a-28fc-4724-bab5-1c2aa87e4d58 10849-004 HUMAN OTC DRUG
Acne Off Acne Treatment Facial SALICYLIC ACID LOTION TOPICAL 20120419
OTC MONOGRAPH FINAL part333D Armand Dupree SALICYLIC ACID 120
mL/100mL
10849-002_468845c0-b070-400d-8efc-afa95acff0ab 10849-002 HUMAN OTC DRUG
Terapie Anti-Fungal MICONAZOLE NITRATE CREAM TOPICAL 20111104
OTC MONOGRAPH FINAL part333C Armand Dupree Inc. MICONAZOLE NITRA
TE 2 g/100g
17270-503_401da24a-ec96-4435-9c45-a21939d92edd 17270-503 HUMAN OTC DRUG
Primatene Mist Epinephrine INHALANT ORAL 19840523
ANDA ANDA087907 "Armstrong Pharmaceuticals, Inc." EPINEPHRINE
0.22 mg/1
17270-504_401da24a-ec96-4435-9c45-a21939d92edd 17270-504 HUMAN OTC DRUG
Primatene Mist Refill Epinephrine INHALANT ORAL 19840523
ANDA ANDA087907 "Armstrong Pharmaceuticals, Inc." EPINEPHRINE
0.22 mg/1
55301-117_6b043f0a-5cd6-44f6-b688-715ae07e2dc2 55301-117 HUMAN OTC DRUG
Exchange Select Lansoprazole Lansoprazole "CAPSULE, DELAYED RELEAS
E" ORAL 20120611 ANDA ANDA202319 Army & Air Force
Exchange Service LANSOPRAZOLE 15 mg/1
55301-271_fdddcb3e-9edb-4478-8c35-7ba36ec47191 55301-271 HUMAN OTC DRUG
exchange select acid reducer Ranitidine TABLET ORAL 20120912
ANDA ANDA076760 Army & Air Force Exchange Service RANITIDINE HYDRO
CHLORIDE 75 mg/1
55301-357_6b272dd2-34f2-4d32-92b5-3967be18f579 55301-357 HUMAN OTC DRUG
exchange select antacid regular strength "Aluminum hydroxide, Magnesium h
ydroxide, Simethicone" LIQUID ORAL 20130108 OTC MONOGRAPH FI
NAL part331 Army & Air Force Exchange Service ALUMINUM HYDROXIDE; DIME
THICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL
55301-368_4e96403a-8218-41e3-9d6c-b5335965ba57 55301-368 HUMAN OTC DRUG
exchange select naproxen sodium Naproxen Sodium "TABLET, FILM COATED"
ORAL 20080826 ANDA ANDA074661 Army & Air Force Exchang
e Service NAPROXEN SODIUM 220 mg/1
55301-388_40d2090d-c332-4dcb-9f43-5ee467e7b3d1 55301-388 HUMAN OTC DRUG
Exchange Select Nasal Oxymetazoline HCl SPRAY NASAL 20140106
OTC MONOGRAPH FINAL part341 Army & Air Force Exchange Service OXYMETAZ
OLINE HYDROCHLORIDE 0.05 g/100mL
55301-468_fa8e049c-1dda-4030-bee6-71a422023790 55301-468 HUMAN OTC DRUG
Exchange Select Calcium Antacid Calcium carbonate "TABLET, CHEWABL
E" ORAL 20110609 OTC MONOGRAPH FINAL part331 Army & A
ir Force Exchange Service CALCIUM CARBONATE 750 mg/1
55301-478_06ed726f-71e7-43c8-bf83-c28c139eda87 55301-478 HUMAN OTC DRUG
Exchange Select Calcium Antacid calcium carbonate "TABLET, CHEWABL
55301-489_2cdc1a78-8140-46b6-b22e-e124f2ec46e9 55301-489 HUMAN OTC DRUG
Exchange Select Calcium Antacid Calcium carbonate "TABLET, CHEWABL
55301-571_44f7c76d-196a-49f7-a0bf-632b9ac643c7 55301-571 HUMAN OTC DRUG
exchange select allergy relief fexofenadine hydrochloride "TABLET,
FILM COATED" ORAL 20110926 ANDA ANDA076447 Army & A
ir Force Exchange Service FEXOFENADINE HYDROCHLORIDE 180 mg/1
55301-590_c3d0efbf-efcf-425d-a033-652c983c3529 55301-590 HUMAN OTC DRUG
Exchange Select Allergy Relief Cetirizine Hydrochloride TABLET
e Service CETIRIZINE HYDROCHLORIDE 10 mg/1
55301-612_c5e9bc88-ae9c-4369-99b5-502d10c31e8f 55301-612 HUMAN OTC DRUG
exchange select allergy relief Loratadine TABLET ORAL 20080826
ANDA ANDA076301 Army & Air Force Exchange Service LORATADINE
10 mg/1
55301-852_5ece41c3-2daf-4d78-90a2-9ff0bd1fbf50 55301-852 HUMAN OTC DRUG
Exchange Select Acid Reducer Ranitidine "TABLET, FILM COATED"
e Service RANITIDINE HYDROCHLORIDE 150 mg/1
55301-915_4a6bc207-6d41-4067-90f5-bd978168be7c 55301-915 HUMAN OTC DRUG
exchange select omeprazole Omeprazole "TABLET, DELAYED RELEASE
" ORAL 20081028 NDA NDA022032 Army & Air Force
Exchange Service OMEPRAZOLE 20 mg/1
55301-939_497df1ad-c032-474f-aae4-1235f7e6f6cd 55301-939 HUMAN OTC DRUG
e Service CETIRIZINE HYDROCHLORIDE 10 mg/1
55301-004_9e609228-1ecd-47b1-95db-830f2072207d 55301-004 HUMAN OTC DRUG
Kids Flouride Rinse Sodium Fluoride RINSE ORAL 20110209
OTC MONOGRAPH FINAL part355 Army + Air Force Exchange Service SODIUM F
LUORIDE 0.05 kg/100L
55301-213_d260eb73-b947-4911-9627-f7387c64b23d 55301-213 HUMAN OTC DRUG
Anticavity Fluoride Rinse Sodium Fluoride MOUTHWASH ORAL
20041224 OTC MONOGRAPH FINAL part355 Army + Air Force Exchang
e Service SODIUM FLUORIDE 0.05 kg/100L
55301-406_9c34c498-6110-4c1e-9311-823753ca0702 55301-406 HUMAN OTC DRUG
Exchange Select Cold Sore Treatment Benzalkonium Chloride CREAM
TOPICAL 20110804 OTC MONOGRAPH NOT FINAL part333A Army + A
ir Force Exchange Service BENZALKONIUM CHLORIDE 1.3 mg/g
55301-871_90058aaa-092d-447c-b748-ff56f1b8189c 55301-871 HUMAN OTC DRUG
Hydrogen Peroxide Hydrogen Peroxide SOLUTION TOPICAL
20021010 OTC MONOGRAPH NOT FINAL part333A Army + Air Force
Exchange Service HYDROGEN PEROXIDE 0.3 kg/100L
55301-000_9a44a271-73ba-497e-bbea-f7c57e84de6b 55301-000 HUMAN OTC DRUG
Exchange Select Sunscreen SPF 15 OCTINOXATE OXYBENZONE LOTION TOPICAL
20121115 OTC MONOGRAPH NOT FINAL part352 ARMY AND AIR FORCE EXCHA
NGE SERVICE OCTINOXATE; OXYBENZONE 7.5; 4.5 g/100g; g/100g
55301-001_297e84d7-c76d-485d-9d34-99d2eff5be6a 55301-001 HUMAN OTC DRUG
Exchange Select Sunscreen SPF 45 OCTINOXATE OXYBENZONE LOTION TOPICAL
NGE SERVICE AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
2; 12; 5; 1.6; 3.5 g/100g; g/100g; g/100g; g/100g; g/100g
55301-002_607e1534-a267-4be3-bad7-3edcf4bd31af 55301-002 HUMAN OTC DRUG
Exchange Select Sport Sunscreen SPF 15 OCTINOXATE OXYBENZONE LOTION TOPICAL
NGE SERVICE OCTINOXATE; OCTISALATE; OXYBENZONE 6; 5; 2 g/100g; g/100g;
g/100g
55301-003_aa1d3f09-19c9-44fb-926c-6b4b98b6ccb3 55301-003 HUMAN OTC DRUG
Exchange Select Sport Sunscreen SPF 30 OCTINOXATE OXYBENZONE LOTION TOPICAL
NGE SERVICE AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
2; 10; 5; 4; 5 g/100g; g/100g; g/100g; g/100g; g/100g
55301-005_d55a4fd0-4745-4ad6-8ada-f22cd96ef4eb 55301-005 HUMAN OTC DRUG
Exchange Select Dark Tanning Sunscreen SPF 4 OCTOCRYLENE LOTION TOPICAL
NGE SERVICE OCTOCRYLENE; OXYBENZONE 1; .5 g/100g; g/100g
55301-006_216e5585-94dc-46b6-bb0c-08f085fce521 55301-006 HUMAN OTC DRUG
Exchange Select Baby Sunscreen SPF 50 AVOBENZONE LOTION TOPICAL 20131007
OTC MONOGRAPH NOT FINAL part352 ARMY AND AIR FORCE EXCHANGE SERVICE AVOBENZO
NE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 g/100g;
g/100g; g/100g; g/100g; g/100g
55301-007_764157c9-eb74-401e-b8aa-57504389c2c9 55301-007 HUMAN OTC DRUG
Exchange Select Kids Sunscreen SPF 50 AVOBENZONE SPRAY TOPICAL 20131015
g/100g; g/100g; g/100g; g/100g
55301-008_7fe0f16f-903e-4384-b1a1-a0c358272e88 55301-008 HUMAN OTC DRUG
Exchange Select Sunscreen SPF 50 AVOBENZONE LOTION TOPICAL 20131018
g/100g; g/100g; g/100g; g/100g
55301-009_2287e865-d8a3-4426-b994-540b32081649 55301-009 HUMAN OTC DRUG
Exchange Select Sunscreen SPF 30 AVOBENZONE HOMOSALATE OCTOCRYLENE OXYBEN
ZONE LOTION TOPICAL 20121116 OTC MONOGRAPH NOT FINAL part352
ARMY AND AIR FORCE EXCHANGE SERVICE AVOBENZONE; HOMOSALATE; OCTISALATE; OCTO
55301-010_3957a9ea-a3a7-497e-a5fa-be43038dd598 55301-010 HUMAN OTC DRUG
Exchange Select Sport Sunscreen SPF 50 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRY
LENE OXYBENZONE LOTION TOPICAL 20121116 OTC MONOGRAPH NOT FINAL
part352 ARMY AND AIR FORCE EXCHANGE SERVICE AVOBENZONE; HOMOSALATE; OCTISALA
g/100g
55301-011_f9a0eadd-1b4c-4942-a9ea-7333aa642f5d 55301-011 HUMAN OTC DRUG
Exchange Select Sport Sunscreen SPF 30 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRY
g/100g
55301-012_da810782-f3ca-4126-9c70-1c24af7ad34c 55301-012 HUMAN OTC DRUG
Exchange Select Sheer Dry Touch Sunscreen SPF 70 AVOBENZONE HOMOSALATE OC
TISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20131021 OTC MONO
GRAPH NOT FINAL part352 ARMY AND AIR FORCE EXCHANGE SERVICE AVOBENZONE; HOMO
SALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 5; 2.8; 6 g/100g;
g/100g; g/100g; g/100g; g/100g
55301-013_72e1bded-4608-475f-b720-1e56e3ad8f2a 55301-013 HUMAN OTC DRUG
Exchange Select Sunscreen SPF 70 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRY
g/100g
55301-014_c5979230-bf93-4599-a680-e273f15fb3a3 55301-014 HUMAN OTC DRUG
EXSEL SPORT SPF 15 "AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
" LOTION TOPICAL 20130806 OTC MONOGRAPH NOT FINAL part352
CRYLENE 2; 10; 5; 5 g/100g; g/100g; g/100g; g/100g
55301-015_085571e1-72da-48fe-aea6-09ee24d95fe4 55301-015 HUMAN OTC DRUG
EXSEL SPORT SPF 30 "AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBEN
55301-016_b3bc117d-9634-4e5a-8295-a84248905732 55301-016 HUMAN OTC DRUG
EXSEL ALOE LIDOCAINE HYDROCHLORIDE GEL TOPICAL 20130806
OTC MONOGRAPH NOT FINAL part348 ARMY AND AIR FORCE EXCHANGE SERVICE LIDOCAIN
E HYDROCHLORIDE 0.5 g/100g
55301-017_2ad125c1-76c2-40f5-a999-ed51e497d74e 55301-017 HUMAN OTC DRUG
EXCEL SPF 30 "AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE"
LOTION TOPICAL 20130806 OTC MONOGRAPH NOT FINAL part352 ARMY AND
AIR FORCE EXCHANGE SERVICE AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
3; 10; 5; 10 g/100g; g/100g; g/100g; g/100g
55301-018_41200ffd-b261-42fd-bb6b-da663166bb25 55301-018 HUMAN OTC DRUG
EXCEL SPORT SPF 50 "AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBEN
55301-019_0f8c1a8d-cde5-4728-9d0a-7a14c36554b4 55301-019 HUMAN OTC DRUG
EXSEL SPORT SPF 30 "AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBEN
55301-020_c0dc405e-26fb-49a6-80a5-8338eb5598bf 55301-020 HUMAN OTC DRUG
EXCEL SPORT SPF 50 "AVOBENZONE, OCTOCRYLENE, OXYBENZONE" LOTION TOPICAL
NGE SERVICE AVOBENZONE; OCTOCRYLENE; OXYBENZONE 3; 6; 4 g/100g; g/100g;
g/100g
55301-044_4501e75d-7de2-4260-a145-a63cfeebfad3 55301-044 HUMAN OTC DRUG
Exchange Select Burn Relief Pain Relieving LIDOCAINE HYDROCHLORIDE GEL
TOPICAL 20121115 OTC MONOGRAPH NOT FINAL part348 ARMY AND AIR FOR
CE EXCHANGE SERVICE LIDOCAINE HYDROCHLORIDE 0.5 g/100g
55301-094_3669b8d4-81fe-4792-8fb5-836ee54282ef 55301-094 HUMAN OTC DRUG
Hair Regrowth Treatment for Men Extra Strength minoxidil SOLUTION
TOPICAL 20070517 ANDA ANDA075518 Army and Air Force Excha
nge Service MINOXIDIL 50 mg/mL
55301-159_f325b9eb-7246-43f5-9d92-b9b545d845c7 55301-159 HUMAN OTC DRUG
Extra Strength Headache Formula "Acetaminophen, Aspirin and caffeine"
part343 ARMY AND AIR FORCE EXCHANGE SERVICE ACETAMINOPHEN; ASPIRIN; CAFFEINE
250; 250; 65 mg/1; mg/1; mg/1
55301-175_c0667cda-2477-4821-b215-1f64163201ef 55301-175 HUMAN OTC DRUG
Extra Strength Pain Reliever Acetaminophen CAPSULE ORAL 19930402
OTC MONOGRAPH NOT FINAL part343 ARMY AND AIR FORCE EXCHANGE SERVICE ACETAMIN
OPHEN 500 mg/1
55301-189_2ebd3dc1-6ea6-4cbb-802a-900646d5bd22 55301-189 HUMAN OTC DRUG
Sleep-Aid Diphenhydramine HCl TABLET ORAL 19921225
OTC MONOGRAPH FINAL part341 ARMY AND AIR FORCE EXCHANGE SERVICE DIPHENHY
55301-190_fbcc2263-c7ed-4816-9fa8-e5c12ccd3101 55301-190 HUMAN OTC DRUG
Allergy Relief Diphenhydramine HCl CAPSULE ORAL 19900315
OTC MONOGRAPH FINAL part336 ARMY AND AIR FORCE EXCHANGE SERVICE DIPHENHY
55301-226_7498e30d-c7d2-4769-ac93-3a0d56d6fb8d 55301-226 HUMAN OTC DRUG
Stay Awake Caffeine TABLET ORAL 19921121
OTC MONOGRAPH FINAL part340 ARMY AND AIR FORCE EXCHANGE SERVICE CAFFEINE
200 mg/1
55301-227_6fc5ac83-10f7-4dfe-b916-56983d6e5606 55301-227 HUMAN OTC DRUG
Regular Strength Aspirin Aspirin "TABLET, COATED" ORAL
NGE SERVICE ASPIRIN 325 mg/1
55301-253_f1c83752-b63b-4f9c-8e1a-bf4a3d1c4d53 55301-253 HUMAN OTC DRUG
Extra Strength Pain Reliever PM Acetaminophen and Diphenhydramine HCl
part343 ARMY AND AIR FORCE EXCHANGE SERVICE ACETAMINOPHEN; DIPHENHYDRAMINE H
55301-291_30987f6a-9bcb-4693-8938-064b8a57e2f4 55301-291 HUMAN OTC DRUG
Ibuprofen Ibuprofen TABLET ORAL 19880524
ANDA ANDA075010 ARMY AND AIR FORCE EXCHANGE SERVICE IBUPROFEN
200 mg/1
55301-319_d4c1c8f2-ac5c-4fa6-aea7-93bea693c095 55301-319 HUMAN OTC DRUG
Stomach Relief Bismuth Subsalicylate "TABLET, CHEWABLE" ORAL
19980716 OTC MONOGRAPH FINAL part335 ARMY AND AIR FORCE EXCHA
NGE SERVICE BISMUTH SUBSALICYLATE 262 mg/1
55301-329_90f57fe0-c81f-4a66-992b-e3f2b1890c2e 55301-329 HUMAN OTC DRUG
Allergy Relief Diphenhydramine HCl "CAPSULE, COATED" ORAL
19900302 OTC MONOGRAPH FINAL part341 ARMY AND AIR FORCE EXCHA
NGE SERVICE DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1
55301-343_e76990ba-4f7a-4d7c-b71d-b2766e578d11 55301-343 HUMAN OTC DRUG
Hydrocortisone Maximum Strength Hydrocortisone CREAM TOPICAL 20050314
OTC MONOGRAPH NOT FINAL part348 Army and Air Force Exchange Service HYDROCOR
TISONE 1 g/100g
55301-350_7d2a8a16-bba5-425c-922b-5225a6ee6e69 55301-350 HUMAN OTC DRUG
Clotrimazole Antifungal clotrimazole CREAM TOPICAL 20060203
OTC MONOGRAPH FINAL part333C Army and Air Force Exchange Service
CLOTRIMAZOLE 10 mg/g
55301-351_2fb20915-7fd0-4b57-abcc-ed5b70ecc3da 55301-351 HUMAN OTC DRUG
Stool Softener Docusate Sodium "CAPSULE, LIQUID FILLED" ORAL
NGE SERVICE DOCUSATE SODIUM 100 mg/1
55301-369_71379fd9-51fd-4e3d-a98f-38f202afd74d 55301-369 HUMAN OTC DRUG
Maximum Strength Menstrual Pain Relief "Acetaminophen, Pamabrom and Pyr
ilamine maleate" "CAPSULE, COATED" ORAL 20000620
OPHEN; PAMABROM; PYRILAMINE MALEATE 500; 25; 15 mg/1; mg/1; mg/1
55301-373_c78cf35c-2cf5-4105-be53-90b7bce382d4 55301-373 HUMAN OTC DRUG
Pain Relief Medicine PM Acetaminophen and Diphenhydramine Citrate
TABLET ORAL 20040607 OTC MONOGRAPH FINAL part341 ARMY AND
AIR FORCE EXCHANGE SERVICE ACETAMINOPHEN; DIPHENHYDRAMINE CITRATE 500; 38
mg/1; mg/1
55301-375_183747d0-1d3e-4721-9f24-a5baa0456f85 55301-375 HUMAN OTC DRUG
Anti Diarrheal Loperamide HCl CAPSULE ORAL 20050503
ANDA ANDA076497 ARMY AND AIR FORCE EXCHANGE SERVICE LOPERAMIDE HYDRO
CHLORIDE 2 mg/1
55301-392_338f2ea2-74c8-4ebc-a229-85aa1ff610d5 55301-392 HUMAN OTC DRUG
Ibuprofen Ibuprofen "TABLET, FILM COATED" ORAL 20020330
200 mg/1
55301-393_19850603-0f5d-4fcc-ad34-f4de62e0f666 55301-393 HUMAN OTC DRUG
Ibuprofen Ibuprofen "CAPSULE, COATED" ORAL 20020408
200 mg/1
55301-403_d8147b3e-52f2-4d98-a312-b144cd355a48 55301-403 HUMAN OTC DRUG
Motion Sickness II Meclizine HCl TABLET ORAL 20020624
OTC MONOGRAPH FINAL part336 ARMY AND AIR FORCE EXCHANGE SERVICE MECLIZIN
E HYDROCHLORIDE 25 mg/1
55301-411_4c05c9ee-aaea-4f8b-bf09-8482ec71b142 55301-411 HUMAN OTC DRUG
Cough and Cold HBP Chlorpheniramine maleate and Dextromethorphan HB
r TABLET ORAL 20030503 OTC MONOGRAPH FINAL part341
ARMY AND AIR FORCE EXCHANGE SERVICE CHLORPHENIRAMINE MALEATE; DEXTROMETHORPH
AN HYDROBROMIDE 4; 30 mg/1; mg/1
55301-414_c45395ae-c1c5-4012-bbf4-cfc621f64df1 55301-414 HUMAN OTC DRUG
Adult Low Strength Aspirin Aspirin "TABLET, COATED" ORAL
55301-442_6867a1c1-40e4-4bdd-a984-1347a8e34e55 55301-442 HUMAN OTC DRUG
Adult Tussin Cough Gels Dextromethorphan HBr "CAPSULE, GELATIN COATED
" ORAL 20060424 OTC MONOGRAPH FINAL part341 ARMY AND
AIR FORCE EXCHANGE SERVICE DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1
55301-447_b2d6de56-d06f-476f-b789-a8e344e8fb10 55301-447 HUMAN OTC DRUG
Childrens Pain Reliever Acetaminophen "TABLET, ORALLY DISINTEGRATING"
ORAL 20050203 OTC MONOGRAPH NOT FINAL part343 ARMY AND AIR FOR
CE EXCHANGE SERVICE ACETAMINOPHEN 80 mg/1
55301-453_2c47566e-8c80-46a3-aad1-4fa4efb71c38 55301-453 HUMAN OTC DRUG
Non-Drowsy Suphedrine PE Congestion Phenylephrine HCl "TABLET,
FILM COATED" ORAL 20041206 OTC MONOGRAPH FINAL part341
ARMY AND AIR FORCE EXCHANGE SERVICE PHENYLEPHRINE HYDROCHLORIDE 10
mg/1
55301-455_1a53803a-c35e-4fd5-b922-049ee9961015 55301-455 HUMAN OTC DRUG
Allergy Mutli-Symptom "Acetaminophen, Chlorpheniramine Maleate and Phe
nylephrine HCl" TABLET ORAL 20060530 OTC MONOGRAPH NOT FINAL
part343 ARMY AND AIR FORCE EXCHANGE SERVICE ACETAMINOPHEN; CHLORPHENIRAMINE
MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1
55301-462_4c72009d-d53f-400c-be40-3222b95a8856 55301-462 HUMAN OTC DRUG
Suphedrine PE Sinus and Allergy Chlorpheniramine maleate and Phenylephri
ne HCl TABLET ORAL 20050609 OTC MONOGRAPH FINAL part341
ARMY AND AIR FORCE EXCHANGE SERVICE CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE
55301-464_016df476-fa7c-4d6e-8544-6a0b05e28ae9 55301-464 HUMAN OTC DRUG
Allergy and Sinus Headache "Acetaminophen, Diphenhydramine HCl and
Phenylephrine HCl" TABLET ORAL 20050615 OTC MONOGRAPH FI
NAL part341 ARMY AND AIR FORCE EXCHANGE SERVICE ACETAMINOPHEN; DIPHENHYD
RAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/1; mg
/1; mg/1
55301-466_b879dd32-80b4-4a9f-bbae-e43fb1eb566f 55301-466 HUMAN OTC DRUG
Sinus Congestion and Pain Acetaminophen and Phenylephrine HCl
TABLET ORAL 20050726 OTC MONOGRAPH NOT FINAL part343 ARMY AND
AIR FORCE EXCHANGE SERVICE ACETAMINOPHEN 325 mg/1
55301-500_3d0b5598-884d-495b-87c2-e8c3e9e2a887 55301-500 HUMAN OTC DRUG
Pre-moistened Medicated WipesHemorrhoidal wipeHemorrhoidal wipeHemorrhoidal wipe
Hemorrhoidal wipe Hemorrhoidal wipes with witch hazel witch hazel
CLOTH TOPICAL 20130701 OTC MONOGRAPH FINAL part346 ARMY AND
AIR FORCE EXCHANGE SERVICE WITCH HAZEL 129 g/258g
55301-519_9e4bd7f8-7530-4b09-90c1-d23deff4b39f 55301-519 HUMAN OTC DRUG
Extra Strength Pain Reliever Acetaminophen "CAPSULE, GELATIN COATED
" ORAL 20040510 OTC MONOGRAPH NOT FINAL part343 ARMY AND
AIR FORCE EXCHANGE SERVICE ACETAMINOPHEN 500 mg/1
55301-525_a497af5d-c981-4d79-ad35-eb6f819d924b 55301-525 HUMAN OTC DRUG
Aphedrid Cold and Allergy Chlorpheniramine maleate and Phenylephri
ne HCl TABLET ORAL 20020722 OTC MONOGRAPH FINAL part341
ARMY AND AIR FORCE EXCHANGE SERVICE CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE
55301-527_13d1c359-0488-4eab-bad5-11d081c3b265 55301-527 HUMAN OTC DRUG
Sinus Congestion and Pain Severe "Aceetaminophen, Guaifenesin and
Phenylephrine HCl" TABLET ORAL 20050806 OTC MONOGRAPH NO
T FINAL part343 ARMY AND AIR FORCE EXCHANGE SERVICE ACETAMINOPHEN; GUAIFENES
55301-529_5954cd7e-ef28-4cd3-85fa-8ea7b1ffc0a0 55301-529 HUMAN OTC DRUG
Multi-Symptom Cold Relief "Acetaminophen, Chlorpehniramine HCl, De
xtromethorphan HBr, Phenylephrine HCl" KIT 20050721
OTC MONOGRAPH FINAL part341 ARMY AND AIR FORCE EXCHANGE SERVICE
55301-533_e8f2d092-9d9f-46e6-a09a-e57ab312a211 55301-533 HUMAN OTC DRUG
Mucus Relief DM Dextromethorphan HBr and Guiafenesin "TABLET, FILM CO
ATED" ORAL 20051231 OTC MONOGRAPH FINAL part341 ARMY AND
AIR FORCE EXCHANGE SERVICE DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
20; 400 mg/1; mg/1
55301-534_c28a0f2e-a277-4290-a3c6-fec117aad6d9 55301-534 HUMAN OTC DRUG
Daytime Cold and Flu Relief "Acetaminophen, Dextromethorphan HBr, Ph
enylephrine HCl" "CAPSULE, LIQUID FILLED" ORAL 20070919
OPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10;
5 mg/1; mg/1; mg/1
55301-556_a7860fc3-3505-45d4-88ff-8c39140ce689 55301-556 HUMAN OTC DRUG
Extra Strength Pain Reliever PM Acetaminophen and Diphenhydramine HCl
CAPSULE ORAL 20071217 OTC MONOGRAPH NOT FINAL part341 ARMY AND
AIR FORCE EXCHANGE SERVICE ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
500; 25 mg/1; mg/1
55301-559_04776a1e-b2c7-435d-9716-c190c8568f1a 55301-559 HUMAN OTC DRUG
Allergy Multi-Symptom "Acetaminophen, Phenylephrine HCl, Chlorpheniram
ine maleate" "CAPSULE, GELATIN COATED" ORAL 20080317
OTC MONOGRAPH FINAL part341 ARMY AND AIR FORCE EXCHANGE SERVICE ACETAMIN
OPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5
mg/1; mg/1; mg/1
55301-600_012b7554-d392-46d1-ab63-b54d8f4c583d 55301-600 HUMAN OTC DRUG
Low Dose Aspirin Aspirin TABLET ORAL 20080212
OTC MONOGRAPH NOT FINAL part343 ARMY AND AIR FORCE EXCHANGE SERVICE ASPIRIN
81 mg/1
55301-615_e83fb3ed-675a-4f20-8c1f-75ab48c9377d 55301-615 HUMAN OTC DRUG
Maximum Strength Multi-Symptom Cold and Sinus "Acetaminophen, Guaifene
sin, Phenylephrine HCl" TABLET ORAL 20130407 OTC MONOGRAPH FI
NAL part341 ARMY AND AIR FORCE EXCHANGE SERVICE ACETAMINOPHEN; GUAIFENES
55301-616_6f9e89eb-5725-4709-854d-1273ddef7a90 55301-616 HUMAN OTC DRUG
Maximum Strength Mucus Relief Cold Flu and Sore Throat "Acetaminophen,
Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl" TABLET ORAL 20130407
OTC MONOGRAPH FINAL part341 ARMY AND AIR FORCE EXCHANGE SERVICE ACETAMIN
OPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1
55301-623_f263c374-4d3a-47b2-b363-e498d3b736d8 55301-623 HUMAN OTC DRUG
Womens Gentle Laxative Bisacodyl "TABLET, COATED" ORAL
NGE SERVICE BISACODYL 5 mg/1
55301-821_a9d8d8cc-6c71-40d8-903b-784e1573bbd7 55301-821 HUMAN OTC DRUG
Adult Chewable Low Dose Aspirin Aspirin "TABLET, CHEWABLE" ORAL
55301-992_92e8d27b-8558-48a6-bfc7-4c74c02fb099 55301-992 HUMAN OTC DRUG
Allergy Relief Diphenhydramine HCl "CAPSULE, LIQUID FILLED"
ORAL 20010913 OTC MONOGRAPH FINAL part336 ARMY AND AIR FOR
CE EXCHANGE SERVICE DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1
50246-100_90e147c3-21fc-48b2-8e0d-06ddf7d2f45c 50246-100 HUMAN OTC DRUG
Ultra Care-aid Sanitizer Antiseptic Hand Sanitizer Citric Fragrance with Aloe Ve
ra ALCOHOL GEL TOPICAL 20100208 OTC MONOGRAPH FI
NAL part333 "Aromaticos Quimicos Potosinos, S.A. de C.V." ALCOHOL 62
mL/100mL
76016-544_6b75cea8-8adf-4f87-aec9-dfa2b69b9fa9 76016-544 HUMAN OTC DRUG
Pure Kleen CHLOROXYLENOL SOAP TOPICAL 20110101
OTC MONOGRAPH NOT FINAL part333E "Arrow-Magnolia International, Inc."
CHLOROXYLENOL 0.003 mL/mL
66831-123_b7144551-cebd-4345-b476-307289789f45 66831-123 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS Arroyo Medical Supply dba Zia Health Care
OXYGEN 99 L/100L
55655-120_89646782-0b06-4168-bcb2-6a5bc0be387d 55655-120 HUMAN OTC DRUG
LIVESTS Titanium dioxide CREAM TOPICAL 20130401
OTC MONOGRAPH NOT FINAL part352 ARSOA USA INC. TITANIUM DIOXIDE 2.522
g/25mL
55655-121_e6157f02-7754-4abc-bb9f-2107f07e407f 55655-121 HUMAN OTC DRUG
LIVESTS Moist Liquid TITANIUM DIOXIDE LIQUID TOPICAL 20130401
g/30mL
55655-122_45145c91-7570-4c19-9f94-49903f1f0008 55655-122 HUMAN OTC DRUG
g/30mL
55655-123_d279ebec-3d6c-434e-888f-02ce7df4dcb8 55655-123 HUMAN OTC DRUG
g/30mL
42221-0001_d7b58d6d-6a4c-417d-93d3-607b4334af2f 42221-0001 HUMAN OTC DRUG
MANGO BUTTER LIPSTICK SPF 10 Avobenzone and Octinoxate LIPSTICK
TOPICAL 20100830 OTC MONOGRAPH NOT FINAL part352 ART COSMETICS SR
L AVOBENZONE; OCTINOXATE 2; 6 g/100g; g/100g
76352-001_d28a311d-6483-4df0-aaaf-67f9e768b3bb 76352-001 HUMAN OTC DRUG
Beautos Antibacterial Hand Sanitizer Lemon ALCOHOL LIQUID TOPICAL
20110802 OTC MONOGRAPH NOT FINAL part333E Artec Chemical C
ompany Limited ALCOHOL 62 g/100g
76352-002_ba72fa57-ddab-4f03-afe9-4a1ed212daf2 76352-002 HUMAN OTC DRUG
HAND SANITIZER ALCOHOL GEL TOPICAL 20140714 OTC MONO
GRAPH NOT FINAL part333E Artec Chemical Company Limited ALCOHOL 65
mL/100mL
49765-310_d86f7aa6-1cb2-4c8d-829a-f3de5eb48c81 49765-310 HUMAN OTC DRUG
ARTEMIS Alcohol-Free Antiseptic Foam Hand Sanitizer BENZALKONIUM CHL
ORIDE LIQUID TOPICAL 20110224 OTC MONOGRAPH FINAL part333E
Artemis Bio-Solutions Inc BENZALKONIUM CHLORIDE 0.13 mL/100mL
49765-410_5181a4d6-c9c0-4f4e-8662-b3193e5f28e6 49765-410 HUMAN OTC DRUG
ARTEMIS Alcohol-Free Antiseptic Foam Hand BENZALKONIUM CHLORIDE
SOAP TOPICAL 20110224 OTC MONOGRAPH FINAL part333E
Artemis Bio-Solutions Inc BENZALKONIUM CHLORIDE 0.13 mL/100mL
57893-300_10a3482a-ae21-407c-b509-f9ee2e4efbd4 57893-300 HUMAN PRESCRIPTI
ON DRUG SelRx SELENIUM SULFIDE SHAMPOO TOPICAL 20110831
UNAPPROVED DRUG OTHER "Artesa Labs, LLC" SELENIUM SULFIDE
23 mg/mL
57893-301_dd4a7eb0-1109-4060-986d-4df5d452eae3 57893-301 HUMAN PRESCRIPTI
ON DRUG Utopic UREA CREAM TOPICAL 20110815 UNAPPROV
ED DRUG OTHER "Artesa Labs, LLC" UREA 410 mg/g
57893-302_d087f2b6-bf27-454f-97cf-3a9f3726cbee 57893-302 HUMAN PRESCRIPTI
ON DRUG Vytone "HYDROCORTISONE ACETATE, IODOQUINOL" CREAM TOPICAL
20110729 UNAPPROVED DRUG OTHER "Artesa Labs, LLC"
HYDROCORTISONE ACETATE; IODOQUINOL 19; 10 mg/g; mg/g "Corticosteroid
57893-303_13567600-018b-400e-83f8-4bfdb72fd0c2 57893-303 HUMAN OTC DRUG
Riax BENZOYL PEROXIDE "AEROSOL, FOAM" TOPICAL 20110815
OTC MONOGRAPH FINAL part333D "Artesa Labs, LLC" BENZOYL PEROXIDE
55 mg/g
57893-304_bc5176dc-04d7-4131-8ee2-f4abaae59942 57893-304 HUMAN OTC DRUG
Riax BENZOYL PEROXIDE "AEROSOL, FOAM" TOPICAL 20110815
OTC MONOGRAPH FINAL part333D "Artesa Labs, LLC" BENZOYL PEROXIDE
95 mg/g
53675-100_7abdab3e-6427-49bd-b108-8c898fa8852a 53675-100 HUMAN OTC DRUG
ARUBA ALOE ISLAND REMEDY DAILY ULTRA ALOE "OCTINOXATE, OXYBENZONE"
CREAM TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 ARUBA AL
OE BALM NV OCTINOXATE; OXYBENZONE 7.5; 4.5 mL/100mL; mL/100mL
53675-131_cfb3dd05-e818-4d97-b51f-b5b98655d911 53675-131 HUMAN OTC DRUG
Aruba Aloe Deodorant Ladies Extra Dry Aluminum Chlorohydrate LOTION
TOPICAL 20070101 OTC MONOGRAPH FINAL part350 Aruba Aloe Balm
NV ALUMINUM CHLOROHYDRATE 25 g/100g
53675-132_cc33bfe3-e31b-4ce0-bdd5-443d0f04713e 53675-132 HUMAN OTC DRUG
Aruba Aloe Deodorant Men Extra Dry Aluminum Chlorohydrate LOTION
53675-133_4e409aac-c491-4112-bb9e-ff7ba28b91ca 53675-133 HUMAN OTC DRUG
Aruba Aloe Deodorant Men Musk Aluminum Chlorohydrate LOTION TOPICAL
20070101 OTC MONOGRAPH FINAL part350 Aruba Aloe Balm NV
ALUMINUM CHLOROHYDRATE 16 g/100g
53675-134_4aa884f3-497e-49d6-b2b7-f34b159994b0 53675-134 HUMAN OTC DRUG
Aruba Aloe Deodorant Women Powder Fresh Aluminum Chlorohydrate LOTION
53675-135_e232833e-1be4-4262-9e22-ddbe5e5fbd07 53675-135 HUMAN OTC DRUG
Aruba Aloe Deodorant Women Powder Fresh Aluminum Chlorohydrate LOTION
53675-140_0d0212db-df23-4ebf-abb5-c1148ffeb320 53675-140 HUMAN OTC DRUG
Aruba Aloe Lip Sunscreen and Moisturizer "OXYBENZONE, PADIMATE"
Aruba Aloe Balm NV OXYBENZONE; PADIMATE O 3; 8 g/100g; g/100g
53675-154_1c240b7f-317f-4e06-89dc-198669ab7436 53675-154 HUMAN OTC DRUG
Aruba Aloe Very Water Resistant Sunscreen - For Faces SPF 30 "HOMOSALATE, OCT
INOXATE, PADIMATE O, OXYBENZONE" LOTION TOPICAL 20110706
OTC MONOGRAPH NOT FINAL part352 Aruba Aloe Balm NV HOMOSALATE; OCTINOXATE;
OXYBENZONE; PADIMATE O 8; 7; 3; 4.2 mL/100mL; mL/100mL; mL/100mL; mL/100mL
53675-158_c7886d9a-475f-45f0-ab6b-15cc3fb35667 53675-158 HUMAN OTC DRUG
Aruba Aloe Very Water Resistant Sunscreen SPF 50 "OCTOCRYLENE, OCTINOXATE
, OXYBENZONE, HOMOSALATE, OCTYL SALICYLATE, AVOBENZONE" LOTION TOPICAL 20130226
OTC MONOGRAPH NOT FINAL part352 Aruba Aloe Balm NV AVOBENZONE; HOMOSALATE;
OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 50; 75; 50; 100; 60 mg/mL; m
g/mL; mg/mL; mg/mL; mg/mL; mg/mL
53675-150_3b7cec17-9185-4d27-a4c4-1a3c498e82d6 53675-150 HUMAN OTC DRUG
Aruba Aloe Very Water Resistant Sunscreen "HOMOSALATE, OCTINOXATE,
PADIMATE O , OXYBENZONE" LOTION TOPICAL 20110605 OTC MONO
GRAPH NOT FINAL part352 "Aruba Aloe Balm, NV" HOMOSALATE; OCTINOXATE; OXYBENZO
NE; PADIMATE O 8; 7; 3; 4.2 mL/100mL; mL/100mL; mL/100mL; mL/100mL
53675-152_7345afe5-fae3-46c6-8485-e0a739f8dd4e 53675-152 HUMAN OTC DRUG
Aruba Aloe Very Water Resistant Sunscreen For Kids SPF 30 "HOMOSALATE, OCT
INOXATE, PADIMATE O , OXYBENZONE" LOTION TOPICAL 20110605
OTC MONOGRAPH NOT FINAL part352 "Aruba Aloe Balm, NV" HOMOSALATE; OCTINOXATE;
OXYBENZONE; PADIMATE O 8; 7; 3; 4.2 mL/100mL; mL/100mL; mL/100mL; mL/100mL
53675-155_16307d64-b3e8-4e0f-9170-0fc48c9d9068 53675-155 HUMAN OTC DRUG
Aruba Aloe Very Water Resistant Sunscreen SPF 15 "OCTINOXATE, OXYBENZONE"
LOTION TOPICAL 20110708 OTC MONOGRAPH NOT FINAL part352 "Aruba A
loe Balm, NV" OCTINOXATE; OXYBENZONE 7.5; 4.5 mL/100mL; mL/100mL
53675-157_f712eb74-2f2c-4466-b4fb-06a92181c554 53675-157 HUMAN OTC DRUG
Aruba Aloe Very Water Resistant Sunscreen SPF 8 "OCTINOXATE, OXYBENZONE"
LOTION TOPICAL 20110708 OTC MONOGRAPH NOT FINAL part352 "Aruba A
loe Balm, NV" OCTINOXATE; OXYBENZONE 7; 2 mL/100mL; mL/100mL
54569-0005_11728279-53b0-4398-9e1c-ea93c82b9be9 54569-0005 HUMAN OTC DRUG
aspirin regular strength regular strength Aspirin TABLET ORAL
20060524 OTC MONOGRAPH FINAL part343 A-S Medication Solutions
LLC ASPIRIN 325 mg/1
54569-0014_4b96c23c-ec0e-4fa3-a226-68ffa2ceba41 54569-0014 HUMAN OTC DRUG
Enteric Coated Aspirin Regular Strength TABLET ORAL 20110204
OTC MONOGRAPH FINAL part343 A-S Medication Solutions LLC ASPIRIN 325
mg/1
54569-0023_9df05cfb-9ecc-4370-b717-54c8c3f3d1a1 54569-0023 HUMAN OTC DRUG
TYLENOL Extra Strength Acetaminophen "TABLET, COATED" ORAL
19840819 OTC MONOGRAPH NOT FINAL part343 A-S Medication Solutions
LLC ACETAMINOPHEN 500 mg/1
54569-0024_a5522538-e459-4b54-84bd-164fe4c5dee3 54569-0024 HUMAN PRESCRIPTI
ON DRUG TYLENOL with Codeine acetaminophen and codeine phosphate
TABLET ORAL 19861010 ANDA ANDA085055 A-S Medication S
olutions LLC ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1
"Full Opioid Agonists [MoA],Opioid Agonist [EPC]" CIII
54569-0025_cec9ac46-ae10-4628-a432-8f9a792c88a1 54569-0025 HUMAN PRESCRIPTI
ate TABLET ORAL 19880930 ANDA ANDA089805 A-S Medi
cation Solutions LLC ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg
54569-0075_f2e6084e-8fef-4cbf-b6c7-173d93ba2573 54569-0075 HUMAN PRESCRIPTI
A-S Medication Solutions LLC SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160
54569-0084_83f9dc38-a96c-46ed-a794-40ebbdb3dad4 54569-0084 HUMAN PRESCRIPTI
CAPSULE ORAL 19870218 ANDA ANDA071293 A-S Medication S
olutions LLC AMANTADINE HYDROCHLORIDE 100 mg/1 "Influenza A M2
54569-0117_afd5ec91-5195-4e9e-af9c-e0434e137728 54569-0117 HUMAN PRESCRIPTI
ON DRUG AUGMENTIN amoxicillin and clavulanate potassium "POWDER,
FOR SUSPENSION" ORAL 19901022 NDA NDA050575
A-S Medication Solutions LLC AMOXICILLIN; CLAVULANATE POTASSIUM 250; 62.
5 mg/5mL; mg/5mL "Penicillin-class Antibacterial [EPC],Penicillins [Chemi
cal/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]"
54569-0118_9444cb51-4ea1-4b2d-80d9-deee7fd1fbf7 54569-0118 HUMAN PRESCRIPTI
19830202 ANDA ANDA062421 A-S Medication Solutions LLC
54569-0124_34c016a7-4107-4634-8b2f-74a408109fe3 54569-0124 HUMAN PRESCRIPTI
ON DRUG Erythrocin Stearate ERYTHROMYCIN STEARATE "TABLET, FILM CO
ATED" ORAL 20110801 ANDA ANDA060359 A-S Medication S
olutions LLC ERYTHROMYCIN STEARATE 250 mg/1 "Decreased Sebaceous Gla
nd Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemi
cal/Ingredient]"
54569-0126_d16f0053-62b1-4ee4-8fb1-635a66aa9d4e 54569-0126 HUMAN PRESCRIPTI
" ORAL 20110418 NDA NDA050207 A-S Medication S
olutions LLC ERYTHROMYCIN ETHYLSUCCINATE 200 mg/5mL "Decreased Sebac
54569-0147_d104c89a-d3ef-4018-9ae6-4e5dd468e87c 54569-0147 HUMAN PRESCRIPTI
54569-0158_dfb61538-1af9-4bd5-a407-ae696d88f7ac 54569-0158 HUMAN PRESCRIPTI
NDA NDA009218 A-S Medication Solutions LLC WARFARIN SODIUM 2
54569-0161_c72b63e4-47b1-4885-8327-57620863ffbe 54569-0161 HUMAN PRESCRIPTI
ON DRUG Dilantin PHENYTOIN SODIUM "CAPSULE, EXTENDED RELEA
SE" ORAL 19760827 ANDA ANDA084349 A-S Medication S
olutions LLC PHENYTOIN SODIUM 100 mg/1 "Anti-epileptic Agent [E
PC],Decreased Central Nervous System Disorganized Electrical Activity [PE]"
54569-0172_d7b1e1db-d96d-4b44-9dc6-ca1cd12f51bf 54569-0172 HUMAN PRESCRIPTI
A-S Medication Solutions LLC AMITRIPTYLINE HYDROCHLORIDE 10 mg/1
54569-0181_48cdd99c-0965-4de9-b4de-1af451e99de4 54569-0181 HUMAN PRESCRIPTI
ON DRUG Nitrofurantoin (macrocrystals) nitrofurantoin (macrocrystals)
olutions LLC NITROFURANTOIN 50 mg/1 "Nitrofuran Antibacterial [EPC],
54569-0194_d0cb2ef3-8741-4a2f-81e0-ecffeea7b71d 54569-0194 HUMAN PRESCRIPTI
ON DRUG Imipramine Hydrochloride Imipramine Hydrochloride
A-S Medication Solutions LLC IMIPRAMINE HYDROCHLORIDE 25 mg/1
54569-0197_6b11ddab-632d-49e5-9a4e-bbc17a57a7bd 54569-0197 HUMAN PRESCRIPTI
ON DRUG Phenazopyridine HCl Phenazopyridine HCl TABLET ORAL
20100910 UNAPPROVED DRUG OTHER A-S Medication Solutions
54569-0199_6b11ddab-632d-49e5-9a4e-bbc17a57a7bd 54569-0199 HUMAN PRESCRIPTI
ON DRUG Phenazopyridine HCl Phenazopyridine HCl TABLET ORAL
54569-0222_43baf8f3-2f97-4408-adc3-7c5857c7ecc7 54569-0222 HUMAN PRESCRIPTI
ANDA ANDA085762 A-S Medication Solutions LLC ATROPINE SULFATE; DIPHEN
OXYLATE HYDROCHLORIDE .025; 2.5 mg/1; mg/1 "Antidiarrheal [EPC],Ant
icholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagoni
st [EPC],Cholinergic Muscarinic Antagonists [MoA]" CV
54569-0233_99b98a35-6c9e-4e47-944f-247fe81267b5 54569-0233 HUMAN PRESCRIPTI
ANDA ANDA075798 A-S Medication Solutions LLC ALLOPURINOL 100
54569-0235_99b98a35-6c9e-4e47-944f-247fe81267b5 54569-0235 HUMAN PRESCRIPTI
ANDA ANDA075798 A-S Medication Solutions LLC ALLOPURINOL 300
54569-0239_e9726281-9273-44ab-bcd6-9a828a986c7a 54569-0239 HUMAN OTC DRUG
ORAL 20070524 OTC MONOGRAPH FINAL part341 A-S Medication S
olutions LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1
54569-0241_710f7015-3dac-4926-b9ce-c1fa96dbafc5 54569-0241 HUMAN OTC DRUG
54569-0243_0e333585-4529-4fea-b9fd-b3b8dd830769 54569-0243 HUMAN OTC DRUG
Allergy Chlorpheniramine Maleate TABLET ORAL 19921219
OTC MONOGRAPH FINAL part341 A-S Medication Solutions LLC CHLORPHENIRAMINE
MALEATE 4 mg/1
54569-0285_94b4d48e-db4d-4026-a13f-9f79661efefc 54569-0285 HUMAN PRESCRIPTI
ANDA ANDA078558 A-S Medication Solutions LLC IBUPROFEN 400
54569-0294_a1b8c3f3-356a-4e3c-a612-661d69631cd3 54569-0294 HUMAN PRESCRIPTI
ON DRUG Naprosyn naproxen TABLET ORAL 19760311
NDA NDA017581 A-S Medication Solutions LLC NAPROXEN 500
54569-0302_3c525ad3-8ccb-4310-b385-79bed00a62ba 54569-0302 HUMAN PRESCRIPTI
54569-0303_d046cdd4-05b7-4fb9-937b-d8c4eb2c3a4d 54569-0303 HUMAN PRESCRIPTI
ANDA089160 A-S Medication Solutions LLC ACETAMINOPHEN; HYDROCODONE BITAR
CIII
54569-0304_f4c46e6c-404a-4823-8437-2f4a1c0ff6bd 54569-0304 HUMAN PRESCRIPTI
ANDA ANDA090836 A-S Medication Solutions LLC CEPHALEXIN 250
54569-0305_f4c46e6c-404a-4823-8437-2f4a1c0ff6bd 54569-0305 HUMAN PRESCRIPTI
54569-0311_0810f2ba-b4cb-4e65-b819-31791d5670dc 54569-0311 HUMAN PRESCRIPTI
54569-0313_a3c02e2b-b6fe-46cc-8cfd-3950dba29c89 54569-0313 HUMAN PRESCRIPTI
ON DRUG Sulfasalazine SULFASALAZINE TABLET ORAL 20030701
NDA AUTHORIZED GENERIC NDA007073 A-S Medication Solutions LLC SULFASAL
AZINE 500 mg/1 "Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/In
gredient]"
54569-0322_d7c4676c-f865-4bc5-89bd-358d53e65fd1 54569-0322 HUMAN PRESCRIPTI
ON DRUG Dexamethasone Dexamethasone TABLET ORAL 19750603
ANDA ANDA084613 A-S Medication Solutions LLC DEXAMETHASONE 0.75
ANDA ANDA084612 A-S Medication Solutions LLC DEXAMETHASONE 4
54569-0327_bd47f3e5-58ff-4cf3-86bc-e5740d79c5d7 54569-0327 HUMAN PRESCRIPTI
ON DRUG Medrol METHYLPREDNISOLONE TABLET ORAL 19571024
NDA NDA011153 A-S Medication Solutions LLC METHYLPREDNISOLONE
4 mg/1 "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [
MoA]"
54569-0330_f89b234a-4ec2-48b3-ba36-5867e512ad3c 54569-0330 HUMAN PRESCRIPTI
ANDA ANDA080352 A-S Medication Solutions LLC PREDNISONE 5
mg/1
mg/1
54569-0332_bb52388f-fa2c-4147-983f-dc90f92fa4e1 54569-0332 HUMAN PRESCRIPTI
mg/1
mg/1
54569-0339_aaf1c383-3002-4787-bb23-95a24dd855f0 54569-0339 HUMAN PRESCRIPTI
ON DRUG "Butalbital, Aspirin and Caffeine" "Butalbital, Aspirin and
Caffeine" TABLET ORAL 19790605 ANDA ANDA086162
A-S Medication Solutions LLC ASPIRIN; BUTALBITAL; CAFFEINE 325; 50; 40
mg/1; mg/1; mg/1 "Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Cy
clooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroid
al Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammat
ory Drug [EPC],Central Nervous System Stimulant [EPC],Central Nervous System Sti
mulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient]" CIII
54569-0347_a9ca5f1a-520f-427e-8c39-721ed78ff149 54569-0347 HUMAN PRESCRIPTI
ANDA ANDA201451 A-S Medication Solutions LLC MECLIZINE HYDROCHLORIDE
12.5 mg/1 "Antiemetic [EPC],Emesis Suppression [PE]"
54569-0349_a9ca5f1a-520f-427e-8c39-721ed78ff149 54569-0349 HUMAN PRESCRIPTI
]"
54569-0350_6a5a584d-22b2-4584-88ee-857c204250f9 54569-0350 HUMAN PRESCRIPTI
ON DRUG Prochlorperazine Maleate Prochlorperazine Maleate
A-S Medication Solutions LLC PROCHLORPERAZINE MALEATE 5 mg/1
"Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient]"
54569-0355_6a5a584d-22b2-4584-88ee-857c204250f9 54569-0355 HUMAN PRESCRIPTI
ON DRUG Prochlorperazine Maleate Prochlorperazine Maleate
A-S Medication Solutions LLC PROCHLORPERAZINE MALEATE 10 mg/1
"Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient]"
54569-0384_4b61dfe4-4a46-4d41-8fcb-b0de2c1e5359 54569-0384 HUMAN PRESCRIPTI
ON DRUG Dicloxacillin Sodium Dicloxacillin Sodium CAPSULE ORAL
DICLOXACILLIN SODIUM 250 mg/1 "Penicillin-class Antibacterial [EPC],Pe
54569-0389_6fe8784e-8081-4f4d-a6a2-af1f6f288dc0 54569-0389 HUMAN PRESCRIPTI
ON DRUG DIDREX benzphetamine hydrochloride TABLET ORAL 19601026
NDA NDA012427 A-S Medication Solutions LLC BENZPHETAMINE HYDROCHLOR
IDE 50 mg/1 "Appetite Suppression [PE],Increased Sympathetic Activit
y [PE],Sympathomimetic Amine Anorectic [EPC]" CIII
54569-0392_0c98e4c6-5a04-4659-bec3-d2925a48cdb0 54569-0392 HUMAN PRESCRIPTI
olutions LLC PHENTERMINE HYDROCHLORIDE 30 mg/1 "Appetite Suppre
EPC]" CIV
54569-0396_df4f38b3-8dbc-4771-8472-7c61eda1aa63 54569-0396 HUMAN PRESCRIPTI
ON DRUG Diethylpropion HCl Controlled-Release Diethylpropion hydrochlo
ride TABLET ORAL 19601117 NDA NDA012546 A-S Medi
cation Solutions LLC DIETHYLPROPION HYDROCHLORIDE 75 mg/1 "Appetit
rectic [EPC]" CIV
54569-0406_097999c9-93f1-49dc-8348-ab3642156545 54569-0406 HUMAN PRESCRIPTI
ON DRUG Hydroxyzine Hydrochloride hydroxyzine hydrochloride
A-S Medication Solutions LLC HYDROXYZINE HYDROCHLORIDE 10 mg/1
54569-0417_cb24f895-b785-4919-8b38-baa8b8c49e43 54569-0417 HUMAN PRESCRIPTI
olutions LLC DICYCLOMINE HYDROCHLORIDE 10 mg/1 "Anticholinergic
54569-0419_3150a0fe-1265-4df5-a31c-602d1a089423 54569-0419 HUMAN PRESCRIPTI
ON DRUG Dicyclomine Dicyclomine Hydrochloride TABLET ORAL
DICYCLOMINE HYDROCHLORIDE 20 mg/1 "Anticholinergic [EPC],Cholinerg
54569-0430_28a02251-9953-4ec7-9425-38e9d3d65d66 54569-0430 HUMAN PRESCRIPTI
ON DRUG Chlordiazepoxide Hydrochloride And Clidinium Bromide "CHLORDI
AZEPOXIDE HYDROCHLORIDE, CLIDINIUM BROMIDE" CAPSULE ORAL 20110830
UNAPPROVED DRUG OTHER A-S Medication Solutions LLC CHLORDIAZEPOXIDE
HYDROCHLORIDE; CLIDINIUM BROMIDE 5; 2.5 mg/1; mg/1 "Benzodiazepine
[EPC],Benzodiazepines [Chemical/Ingredient],Anticholinergic [EPC],Decreased Para
sympathetic Acetylcholine Activity [PE],GI Motility Alteration [PE],Digestive/GI
System Activity Alteration [PE],Cholinergic Antagonists [MoA]" CIV
54569-0434_c4f0fd00-60ee-4756-8816-645deb473f0f 54569-0434 HUMAN PRESCRIPTI
ANDA ANDA070184 A-S Medication Solutions LLC METOCLOPRAMIDE HYDROCHLO
onist [EPC]"
54569-0452_6545bcf0-9cd7-4b6d-bf27-60d3e4146eaf 54569-0452 HUMAN PRESCRIPTI
ON DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL
54569-0478_7ce0f8e4-7c0f-4592-825c-eeb2edaa557f 54569-0478 HUMAN PRESCRIPTI
54569-0502_a7f79a22-feba-4a49-931c-103aa1a8ac86 54569-0502 HUMAN PRESCRIPTI
ON DRUG Spironolactone and Hydrochlorothiazide spironolactone and hydro
chlorothiazide "TABLET, FILM COATED" ORAL 19780101 NDA AUTH
ORIZED GENERIC NDA012616 A-S Medication Solutions LLC HYDROCHLOROTHIAZ
IDE; SPIRONOLACTONE 25; 25 mg/1; mg/1 "Aldosterone Antagonist [EPC],Al
dosterone Antagonists [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thia
54569-0505_b6fd2c9a-dd76-4363-8cbd-54d2be7232c3 54569-0505 HUMAN PRESCRIPTI
nists [MoA]"
54569-0510_8c6f2884-d9df-4006-90f0-296d05ac64f0 54569-0510 HUMAN PRESCRIPTI
METHYLDOPA 500 mg/1 "Adrenergic alpha2-Agonists [MoA],Central alpha-
54569-0515_32bff5e0-f1d7-4583-9d36-6c62a33e833e 54569-0515 HUMAN PRESCRIPTI
olutions LLC HYDRALAZINE HYDROCHLORIDE 25 mg/1 "Arteriolar Vaso
54569-0517_32bff5e0-f1d7-4583-9d36-6c62a33e833e 54569-0517 HUMAN PRESCRIPTI
olutions LLC HYDRALAZINE HYDROCHLORIDE 50 mg/1 "Arteriolar Vaso
54569-0547_01c60658-1930-4279-953d-142c8986b93c 54569-0547 HUMAN PRESCRIPTI
54569-0549_01c60658-1930-4279-953d-142c8986b93c 54569-0549 HUMAN PRESCRIPTI
54569-0552_f199a114-9254-408f-872f-cbff30d20705 54569-0552 HUMAN PRESCRIPTI
ANDA ANDA086831 A-S Medication Solutions LLC CHLORTHALIDONE 25
54569-0554_f199a114-9254-408f-872f-cbff30d20705 54569-0554 HUMAN PRESCRIPTI
ANDA ANDA086831 A-S Medication Solutions LLC CHLORTHALIDONE 50
54569-0557_8002fc52-6737-4ffe-bd81-22432b79d291 54569-0557 HUMAN PRESCRIPTI
olutions LLC PROPRANOLOL HYDROCHLORIDE 10 mg/1 "Adrenergic beta
54569-0570_4355d493-fd99-4086-af2f-6c575c46fec7 54569-0570 HUMAN PRESCRIPTI
ANDA ANDA078010 A-S Medication Solutions LLC FUROSEMIDE 80
54569-0572_4a9df87c-ea48-4b64-8c42-93a6a87cb0f7 54569-0572 HUMAN PRESCRIPTI
54569-0574_4a9df87c-ea48-4b64-8c42-93a6a87cb0f7 54569-0574 HUMAN PRESCRIPTI
54569-0626_8d78d9ee-65d6-4a09-826a-78818577afc1 54569-0626 HUMAN OTC DRUG
SudoGest Pseudoephedrine Hydrochloride "TABLET, FILM COATED"
olutions LLC PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg/1
54569-0646_9ce98220-4334-465f-82f3-a16a247a6aa8 54569-0646 HUMAN PRESCRIPTI
ON DRUG Verapamil Hydrochloride Verapamil Hydrochloride "TABLET, FILM CO
olutions LLC VERAPAMIL HYDROCHLORIDE 120 mg/1 "Calcium Channel Antagon
54569-0650_434ee84d-8987-47a9-9e6c-3634ff83e5e2 54569-0650 HUMAN OTC DRUG
SudoGest Pseudoephedrine Hydrochloride TABLET ORAL 19941001
OTC MONOGRAPH FINAL part341 A-S Medication Solutions LLC PSEUDOEPHEDRINE
54569-0679_3fd32a8b-1ed4-4088-9e18-f4a7aa92dbdf 54569-0679 HUMAN PRESCRIPTI
ON DRUG Lo/Ovral-28 norgestrel and ethinyl estradiol KIT
19760301 NDA NDA017802 A-S Medication Solutions LLC
54569-0689_e451dd4c-cec6-44dc-baec-12f734b8ab0f 54569-0689 HUMAN PRESCRIPTI
ON DRUG Ortho-Novum 777 norethindrone and ethinyl estradiol KIT
54569-0765_ba9aed75-4e82-453e-9539-dbbca5a272fd 54569-0765 HUMAN PRESCRIPTI
ON DRUG triamcinolone acetonide triamcinolone acetonide CREAM TOPICAL
54569-0767_adfc2b54-d02f-4e0e-a1f4-ed98e16557da 54569-0767 HUMAN PRESCRIPTI
ON DRUG Triamcinolone Acetonide triamcinolone acetonide OINTMENT
TOPICAL 19780214 ANDA ANDA085691 A-S Medication Solutions
LLC TRIAMCINOLONE ACETONIDE 1 mg/g
54569-0774_8e00c77f-b71f-46a8-a39e-51b2599d1fd8 54569-0774 HUMAN PRESCRIPTI
ON DRUG Nystatin and Triamcinolone Acetonide Nystatin and Triamcinolo
ne Acetonide CREAM TOPICAL 19871222 ANDA ANDA062364
A-S Medication Solutions LLC NYSTATIN; TRIAMCINOLONE ACETONIDE 100000;
1 [USP'U]/g; mg/g "Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient]
"
54569-0793_26e6294a-478b-44a8-8e6a-6afcff6840d3 54569-0793 HUMAN PRESCRIPTI
ON DRUG Betamethasone Valerate Betamethasone Valerate OINTMENT
LLC BETAMETHASONE VALERATE 1.2 mg/g "Corticosteroid [EPC],Corticoste
54569-0809_b078dacc-3369-43d3-b263-415b1a136281 54569-0809 HUMAN PRESCRIPTI
olutions LLC MEDROXYPROGESTERONE ACETATE 10 mg/1 "Progesterone Co
54569-0812_5b932a46-61f8-4cc3-adda-0c5faad6d1c9 54569-0812 HUMAN PRESCRIPTI
ON DRUG Premarin "ESTROGENS, CONJUGATED" "TABLET, FILM COATED"
ORAL 20060101 NDA NDA004782 A-S Medication Solutions
LLC "ESTROGENS, CONJUGATED" 0.625 mg/1 "Estrogen [EPC],Estrogen Recepto
r Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient]"
54569-0813_5b932a46-61f8-4cc3-adda-0c5faad6d1c9 54569-0813 HUMAN PRESCRIPTI
ON DRUG Premarin "ESTROGENS, CONJUGATED" "TABLET, FILM COATED"
LLC "ESTROGENS, CONJUGATED" 1.25 mg/1 "Estrogen [EPC],Estrogen Recepto
r Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient]"
54569-0826_57df76a1-ed82-44f6-912f-d701ae82b864 54569-0826 HUMAN OTC DRUG
Fleet "sodium phosphate, dibasic and sodium phosphate, monobasic"
ENEMA RECTAL 20020510 OTC MONOGRAPH NOT FINAL part334 A-S Medi
cation Solutions LLC "SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHA
TE, MONOBASIC" 7; 19 g/133mL; g/133mL
54569-0838_1d9f8f3f-a8e4-42dc-aa7d-a41a8a8a8fa7 54569-0838 HUMAN PRESCRIPTI
ON DRUG Orphenadrine Citrate Orphenadrine Citrate "TABLET, EXTENDE
D RELEASE" ORAL 19980619 ANDA ANDA040284 A-S Medi
cation Solutions LLC ORPHENADRINE CITRATE 100 mg/1 "Centrally-media
54569-0843_09057de3-9cff-4595-ae51-f1f596e14aa4 54569-0843 HUMAN PRESCRIPTI
ANDA ANDA085159 A-S Medication Solutions LLC METHOCARBAMOL 750
54569-0852_09057de3-9cff-4595-ae51-f1f596e14aa4 54569-0852 HUMAN PRESCRIPTI
54569-0860_d7de179e-8eb9-455f-9cb3-55a0dde9ad2f 54569-0860 HUMAN PRESCRIPTI
SUSPENSION/ DROPS OPHTHALMIC 19611001 NDA NDA01281
3 A-S Medication Solutions LLC PREDNISOLONE ACETATE; SULFACETAMIDE SODI
UM 2; 100 mg/mL; mg/mL "Sulfonamide Antibacterial [EPC],Sulfonamides [C
hemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonist
s [MoA]"
54569-0861_d26bbac4-d399-4759-b194-df1065f5aec8 54569-0861 HUMAN PRESCRIPTI
A-S Medication Solutions LLC PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM
2; 100 mg/g; mg/g "Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/
Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]"
54569-0871_bfb3fe38-5d89-4030-8377-ec0f46f701bd 54569-0871 HUMAN PRESCRIPTI
OPHTHALMIC 19730601 NDA NDA017011 A-S Medication S
olutions LLC PREDNISOLONE ACETATE 10 mg/mL "Corticosteroid [EPC],Co
54569-0898_cf836a1d-a69e-4a61-8a56-6f79827c069c 54569-0898 HUMAN PRESCRIPTI
ON DRUG Flurazepam Flurazepam Hydrochloride CAPSULE ORAL
FLURAZEPAM HYDROCHLORIDE 30 mg/1 "Benzodiazepine [EPC],Benzodiaze
54569-0905_76743946-b94a-43b4-8d02-4747e4d95b9b 54569-0905 HUMAN PRESCRIPTI
ON DRUG temazepam temazepam CAPSULE ORAL 19870421
ANDA ANDA071456 A-S Medication Solutions LLC TEMAZEPAM 15
54569-0907_c2d0eca2-c897-4410-b987-d2829d11a093 54569-0907 HUMAN PRESCRIPTI
NDA NDA021402 A-S Medication Solutions LLC LEVOTHYROXINE SODIUM
54569-0917_62ea9122-3580-43b2-89e2-5b64e9cc627e 54569-0917 HUMAN PRESCRIPTI
ON DRUG Armour Thyroid "THYROID, PORCINE" TABLET ORAL 19960401
UNAPPROVED DRUG OTHER A-S Medication Solutions LLC "THYROID, PORCIN
E" 30 mg/1
E" 60 mg/1
E" 120 mg/1
54569-0927_0537cca4-625e-42ef-873c-f431ba7d630f 54569-0927 HUMAN PRESCRIPTI
ON DRUG Ativan lorazepam TABLET ORAL 20100316
NDA NDA017794 A-S Medication Solutions LLC LORAZEPAM 1
54569-0936_2192bd6b-7fb0-4b2d-8fc2-494b61066b0c 54569-0936 HUMAN PRESCRIPTI
ANDA ANDA077749 A-S Medication Solutions LLC DIAZEPAM 10
54569-0947_16a3b5f1-11f9-4637-8fe8-1fcd9deba053 54569-0947 HUMAN PRESCRIPTI
ON DRUG Diazepam Diazepam TABLET ORAL 19861210
54569-0949_23c27189-0dc2-4b9e-a23a-4fd20448cdd2 54569-0949 HUMAN PRESCRIPTI
54569-0957_23877701-542e-424b-a554-f44d422a15a1 54569-0957 HUMAN PRESCRIPTI
ON DRUG Lortab hydrocodone bitartrate and acetaminophen TABLET
ORAL 19890825 ANDA ANDA089699 A-S Medication Solutions
LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 7.5 mg/1; mg/1
"Opioid Agonist [EPC],Opioid Agonists [MoA]" CIII
54569-0958_c7d8678c-5b65-40f4-a527-e801c36f73b7 54569-0958 HUMAN PRESCRIPTI
ANDA ANDA090035 A-S Medication Solutions LLC FOLIC ACID 1
mg/1
54569-0965_5e6e8693-4b14-4abd-84eb-e358940fb1fb 54569-0965 HUMAN PRESCRIPTI
ANDA ANDA070027 A-S Medication Solutions LLC METRONIDAZOLE 250
]"
54569-0967_8998b000-ff1f-42cd-aefe-0a9fdbbde80c 54569-0967 HUMAN PRESCRIPTI
]"
54569-1001_fd1b6f13-8701-4123-8341-5b03d909d43a 54569-1001 HUMAN PRESCRIPTI
ON DRUG Acetaminophen and Codeine Phosphate ACETAMINOPHEN and CODEIN
E PHOSPHATE SOLUTION ORAL 19810821 ANDA ANDA0875
08 A-S Medication Solutions LLC ACETAMINOPHEN; CODEINE PHOSPHATE
CV
54569-1018_bff28656-50ee-4ab3-8ca9-44f24b5d7fa5 54569-1018 HUMAN PRESCRIPTI
ON DRUG Nystatin Nystatin SUSPENSION ORAL 19880229
ANDA ANDA062876 A-S Medication Solutions LLC NYSTATIN 100000
[USP'U]/mL "Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient]"
54569-1023_f8ade69d-c1a8-4a97-b51f-f0dcfec508e6 54569-1023 HUMAN PRESCRIPTI
ON DRUG Cephalexin Cephalexin "POWDER, FOR SUSPENSION"
LLC CEPHALEXIN 125 mg/5mL "Cephalosporin Antibacterial [EPC],Cepha
54569-1024_f8ade69d-c1a8-4a97-b51f-f0dcfec508e6 54569-1024 HUMAN PRESCRIPTI
54569-1025_42856923-849e-4273-9ee6-0b5bc2331d5c 54569-1025 HUMAN PRESCRIPTI
54569-1036_62ce959a-23dc-4eed-826a-947e53f384a4 54569-1036 HUMAN PRESCRIPTI
ON DRUG MethylPREDNISolone methylprednisolone TABLET ORAL
54569-1046_466f2e01-3244-4d52-a772-6c16ab45b317 54569-1046 HUMAN PRESCRIPTI
SYRUP ORAL 20060426 ANDA ANDA040643 A-S Medication S
olutions LLC PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL "Phenothiazine [
54569-1047_4dde2e7d-549a-4c99-b8df-59d48813deed 54569-1047 HUMAN PRESCRIPTI
ON DRUG Promethazine VC With Codeine "Codeine Phosphate, Promethazine
Hydrochloride, and Phenylephrine Hydrochloride" SYRUP ORAL 20061207
ANDA ANDA040660 A-S Medication Solutions LLC CODEINE PHOSPHATE; PHENY
LEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE 10; 5; 6.25 mg/5mL;
mg/5mL; mg/5mL "Full Opioid Agonists [MoA],Opioid Agonist [EPC],Phenothiazine [
EPC],Phenothiazines [Chemical/Ingredient],alpha-1 Adrenergic Agonist [EPC],Adren
ergic alpha1-Agonists [MoA]" CV
54569-1051_d3af1d05-a1ed-4351-8d07-db204e07e6f7 54569-1051 HUMAN OTC DRUG
Delsym Dextromethorphan "SUSPENSION, EXTENDED RELEASE" ORAL
DEXTROMETHORPHAN 30 mg/5mL
54569-1054_a41b19cd-381d-4ba5-bee7-4b8188751910 54569-1054 HUMAN PRESCRIPTI
ON DRUG Promethazine VC Promethazinehydrochloride and phenylephrine hydr
ochloride SYRUP ORAL 20061207 ANDA ANDA040654
A-S Medication Solutions LLC PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROC
HLORIDE 5; 6.25 mg/5mL; mg/5mL "Phenothiazine [EPC],Phenothiazines [Chemical/In
gredient],alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA]"
54569-1055_2c78724a-29d9-4dbb-8423-c56bb498caf5 54569-1055 HUMAN PRESCRIPTI
ON DRUG PROMETHAZINE DM Dextromethorphan Hydrobromide and Promethazine H
ydrochloride SYRUP ORAL 20060214 ANDA ANDA040649
A-S Medication Solutions LLC DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDR
OCHLORIDE 15; 6.25 mg/5mL; mg/5mL "Uncompetitive N-methyl-D-aspart
Antagonists [MoA],Sigma-1 Receptor Agonists [MoA],Phenothiazine [EPC],Phenothiaz
ines [Chemical/Ingredient]"
54569-1056_00bd0f6f-a02e-4dce-99b5-699d9aa6d1c9 54569-1056 HUMAN PRESCRIPTI
50 A-S Medication Solutions LLC CODEINE PHOSPHATE; PROMETHAZINE HYDROCHL
54569-1084_ca255b2c-f6eb-4c4c-b052-2ebc372c79cf 54569-1084 HUMAN PRESCRIPTI
54569-1086_64614632-b086-4706-b860-ef6373e28821 54569-1086 HUMAN PRESCRIPTI
ON DRUG SILVADENE SILVER SULFADIAZINE CREAM TOPICAL 19731126
NDA NDA017381 A-S Medication Solutions LLC SILVER SULFADIAZINE
10 mg/g "Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredie
nt]"
54569-1088_60aa510d-3b07-4c93-b4ed-2e3dca360051 54569-1088 HUMAN PRESCRIPTI
ON DRUG SILVADENE SILVER SULFADIAZINE CREAM TOPICAL 19731126
NDA NDA017381 A-S Medication Solutions LLC SILVER SULFADIAZINE
10 mg/g "Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredie
nt]"
54569-1096_44fe1a31-79e1-461b-a7f7-a2f6b33e5688 54569-1096 HUMAN OTC DRUG
Hydrocortisone hydrocortisone CREAM TOPICAL 20011001
OTC MONOGRAPH NOT FINAL part348 A-S Medication Solutions LLC HYDROCORTISONE
10 mg/g
54569-1104_fe77a039-400c-46d5-b71f-1931f1dfb257 54569-1104 HUMAN PRESCRIPTI
54569-1111_82c4934e-1574-4c7f-ae0e-7a3ea8c614ad 54569-1111 HUMAN OTC DRUG
TRIPLE ANTIBIOTIC bacitracin zinc neomycin sulfate polymyxin b sul
fate OINTMENT TOPICAL 20110601 OTC MONOGRAPH FINAL
part333B A-S Medication Solutions LLC BACITRACIN ZINC; NEOMYCIN SULFAT
54569-1113_902d9d45-f8ba-41db-a8d2-ccbf0a1d7972 54569-1113 HUMAN PRESCRIPTI
CREAM TOPICAL 19840626 NDA NDA019137 A-S Medication S
olutions LLC BETAMETHASONE DIPROPIONATE 0.5 mg/g "Corticosteroid
54569-1114_902d9d45-f8ba-41db-a8d2-ccbf0a1d7972 54569-1114 HUMAN PRESCRIPTI
OINTMENT TOPICAL 19840904 NDA NDA019141 A-S Medi
cation Solutions LLC BETAMETHASONE DIPROPIONATE 0.5 mg/g "Cortico
54569-1115_0e6cd631-2865-445e-b40d-7edb2804eca8 54569-1115 HUMAN PRESCRIPTI
ON DRUG BETAMETHASONE VALERATE Betamethasone Valerate CREAM TOPICAL
BETAMETHASONE VALERATE 1 mg/g "Corticosteroid [EPC],Corticosteroid Hor
54569-1118_bcd3d347-b247-4ef7-9158-de3dd0d73477 54569-1118 HUMAN OTC DRUG
hydrocortisone hydrocortisone OINTMENT TOPICAL 20110818
OTC MONOGRAPH NOT FINAL part348 A-S Medication Solutions LLC HYDROCORTISONE
1 g/100g
54569-1124_d1fa0d81-1cf3-40f4-ab9b-1ceaa55d977c 54569-1124 HUMAN PRESCRIPTI
ON DRUG Triamcinolone Acetonide triamcinolone acetonide OINTMENT
LLC TRIAMCINOLONE ACETONIDE 1 mg/g
54569-1125_3aa0a8ac-1396-45a7-b9d8-850a450a50d7 54569-1125 HUMAN PRESCRIPTI
ON DRUG Nystatin nystatin CREAM TOPICAL 20060531
54569-1139_34f78e15-26da-489c-b213-4f574a709c51 54569-1139 HUMAN PRESCRIPTI
ON DRUG SELENIUM SULFIDE SELENIUM SULFIDE LOTION TOPICAL
SELENIUM SULFIDE 2.5 mg/100mL
54569-1143_8e00c77f-b71f-46a8-a39e-51b2599d1fd8 54569-1143 HUMAN PRESCRIPTI
ne Acetonide OINTMENT TOPICAL 19930329 ANDA ANDA0633
05 A-S Medication Solutions LLC NYSTATIN; TRIAMCINOLONE ACETONIDE
100000; 1 [USP'U]/g; mg/g "Polyene Antifungal [EPC],Polyenes [Chemical/Ing
redient]"
54569-1144_af8c833a-9aaa-42ea-aef3-e4d9deda6d87 54569-1144 HUMAN PRESCRIPTI
ON DRUG Gentamicin sulfate Gentamicin Sulfate OINTMENT
LLC GENTAMICIN 1 mg/g "Aminoglycoside Antibacterial [EPC],Amin
54569-1152_0b496fd8-8fb2-4c5f-a6ff-dc3edbdd8228 54569-1152 HUMAN PRESCRIPTI
ON DRUG Retin-A Tretinoin CREAM TOPICAL 19740730
NDA NDA017522 A-S Medication Solutions LLC TRETINOIN 0.5
mg/g "Retinoid [EPC],Retinoids [Chemical/Ingredient]"
54569-1154_9084343b-f80a-4e39-a950-ca82d6f14f12 54569-1154 HUMAN PRESCRIPTI
ANDA ANDA089414 A-S Medication Solutions LLC HYDROCORTISONE 25
54569-1155_2f3b92dc-a059-4570-b96e-e20391778208 54569-1155 HUMAN PRESCRIPTI
ON DRUG Nystatin nystatin CREAM TOPICAL 20060531
54569-1182_7c8e2001-2647-4fd0-a2e1-3a5d080262b3 54569-1182 HUMAN PRESCRIPTI
ON DRUG TOBREX tobramycin OINTMENT OPHTHALMIC 19810628
NDA NDA050555 A-S Medication Solutions LLC TOBRAMYCIN 3
mg/g "Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient
]"
54569-1186_b0e23007-c8f6-41f7-acb5-a51963c53e00 54569-1186 HUMAN PRESCRIPTI
ON DRUG Sulfacetamide Sodium Sulfaccetamide Sodium SOLUTION/ DROPS
OPHTHALMIC 20040701 ANDA ANDA040066 A-S Medication S
olutions LLC SULFACETAMIDE SODIUM 100 mg/mL "Sulfonamide Antibacteri
al [EPC],Sulfonamides [Chemical/Ingredient]"
54569-1188_dfc13b9e-15f1-40dd-bc59-b1eb48ee5dac 54569-1188 HUMAN PRESCRIPTI
ON DRUG NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN "neomyci
n sulfate, polymyxin b sulfate and gramicidin" SOLUTION/ DROPS OPHTHALMIC
GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE .025; 1.75; 10000
mg/mL; mg/mL; [USP'U]/mL "Aminoglycoside Antibacterial [EPC],Aminoglycosi
des [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemic
al/Ingredient]"
54569-1193_491723a2-2879-4866-a9b8-cfe1ede3fd43 54569-1193 HUMAN PRESCRIPTI
ERYTHROMYCIN 5 mg/g "Decreased Sebaceous Gland Activity [PE],Macroli
54569-1218_debfff94-cadc-446f-b3cd-d780a66a54a7 54569-1218 HUMAN PRESCRIPTI
olutions LLC GENTAMICIN SULFATE 3 mg/mL "Aminoglycoside Antibact
54569-1229_b44f1692-a3eb-46b7-b13a-f5a6f3341916 54569-1229 HUMAN PRESCRIPTI
GENTAMICIN SULFATE 3 mg/g "Aminoglycoside Antibacterial [EPC],Amin
54569-1231_76b78aae-596a-467c-9717-bfa99ce7bf47 54569-1231 HUMAN OTC DRUG
Artificial Tears Polyvinyl Alcohol SOLUTION/ DROPS OPHTHALM
IC 20111007 OTC MONOGRAPH FINAL part349 A-S Medication S
olutions LLC POLYVINYL ALCOHOL 14 mg/mL
54569-1270_17488f08-2b60-4017-9cc3-6d744f60d4c5 54569-1270 HUMAN PRESCRIPTI
ON DRUG Multi-Vit with Fluoride dl-alpha-tocoheryl acetate and ascorbic
acid and cholecalciferol and cyanocobalamin and niacinamide and pyridoxine hydro
chloride and riboflavin and fluoride and thiamin hydrochloride and vitamin A pal
mitate SOLUTION ORAL 19970418 UNAPPROVED DRUG OTHER
A-S Medication Solutions LLC ".ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID;
CHOLECALCIFEROL; CYANOCOBALAMIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLA
VIN; SODIUM FLUORIDE; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE" 5; 35; 4
00; 2; 8; .4; .6; .25; .5; 1500 [iU]/mL; mg/mL; [iU]/mL; ug/mL; mg/mL; mg/mL; mg
/mL; mg/mL; mg/mL; [iU]/mL "Vitamin A [Chemical/Ingredient],Vitamin A [EPC]
,Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredie
nt],Vitamin B12 [EPC]"
54569-1280_236dc5ee-b9a0-4fad-bb9f-65b7727a9f7d 54569-1280 HUMAN PRESCRIPTI
ON DRUG Tri-Vit with Fluoride Drops ascorbic acid and cholecalcifero
l and sodium fluoride and vitamin A palmitate SOLUTION ORAL 19950401
UNAPPROVED DRUG OTHER A-S Medication Solutions LLC ASCORBIC ACID; C
HOLECALCIFEROL; SODIUM FLUORIDE; VITAMIN A PALMITATE 35; 400; .25; 1500
mg/mL; [iU]/mL; mg/mL; [iU]/mL "Vitamin A [Chemical/Ingredient],Vitamin A [EPC]
,Vitamin D [Chemical/Ingredient],Vitamin D [EPC]"
54569-1285_cb50cbc8-b609-4c6b-8f97-d4d39fa42d45 54569-1285 HUMAN PRESCRIPTI
ON DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride SOLUTION
OROPHARYNGEAL 20070227 ANDA ANDA040708 A-S Medication S
olutions LLC LIDOCAINE HYDROCHLORIDE 20 mg/mL "Amide Local Anesthetic
54569-1411_b9693943-5b1a-471f-8eb7-ffe3ce786562 54569-1411 HUMAN PRESCRIPTI
ON DRUG Depo-Testosterone testosterone cypionate "INJECTION, SOLU
TION" INTRAMUSCULAR 19790725 ANDA ANDA085635 A-S Medi
cation Solutions LLC TESTOSTERONE CYPIONATE 200 mg/mL "Androgen [EPC],
Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient]"
54569-1444_b0eb3e96-0f3c-4cbb-a8ce-0985efcc16da 54569-1444 HUMAN PRESCRIPTI
A-S Medication Solutions LLC PROPARACAINE HYDROCHLORIDE 5 mg/mL
"Local Anesthesia [PE],Local Anesthetic [EPC]"
54569-1470_87634807-b086-47d4-a74b-79fbc43a6b9f 54569-1470 HUMAN PRESCRIPTI
olutions LLC TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhib
itor [EPC]
54569-1518_34944625-c156-40bc-b07f-9a6fb2fdd09a 54569-1518 HUMAN PRESCRIPTI
LLC INDOMETHACIN 75 mg/1 "Cyclooxygenase Inhibitors [MoA],Nonster
matory Drug [EPC]"
54569-1524_b632c5b4-b63f-4b1b-b9bc-2c2234e58eeb 54569-1524 HUMAN PRESCRIPTI
ON DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ANHYDROUS
"INJECTION, SOLUTION" INFILTRATION 20100330 ANDA ANDA0883
27 A-S Medication Solutions LLC LIDOCAINE HYDROCHLORIDE ANHYDROUS
54569-1544_898851cb-7f52-422e-99dc-432f95d3f2e0 54569-1544 HUMAN PRESCRIPTI
ON DRUG Fluocinolone Acetonide fluocinolone acetonide CREAM TOPICAL
FLUOCINOLONE ACETONIDE 0.1 mg/g "Corticosteroid [EPC],Corticosteroid Hor
54569-1555_ad2fd209-eabf-4c2e-bcdf-3a4f2b9bbcb5 54569-1555 HUMAN PRESCRIPTI
ON DRUG SOLU-MEDROL methylprednisolone sodium succinate "INJECTI
ON, POWDER, FOR SOLUTION" INTRAMUSCULAR; INTRAVENOUS 19590402
NDA NDA011856 A-S Medication Solutions LLC METHYLPREDNISOLONE SODIU
M SUCCINATE 125 mg/mL "Corticosteroid [EPC],Corticosteroid Hormone Rec
54569-1556_7bc09725-7955-4a55-8737-df4ce0ca385b 54569-1556 HUMAN PRESCRIPTI
LOTION TOPICAL 20060630 ANDA ANDA072538 A-S Medication S
54569-1585_007344f0-4110-4553-a223-2e6c01c2698a 54569-1585 HUMAN PRESCRIPTI
ANDA ANDA072927 A-S Medication Solutions LLC LORAZEPAM 1
54569-1640_cca80a77-b982-4edc-b162-eb90341ad011 54569-1640 HUMAN PRESCRIPTI
SYRUP ORAL 19950309 ANDA ANDA087294 A-S Medication S
olutions LLC HYDROXYZINE HYDROCHLORIDE 10 mg/5mL "Antihistamine [
EPC],Histamine Receptor Antagonists [MoA]"
54569-1647_05ef31fe-54fd-4003-a97f-92b6328d389b 54569-1647 HUMAN PRESCRIPTI
ON DRUG Lidocaine Hydrochloride and Epinephrine LIDOCAINE HYDROCHLORIDE
ANHYDROUS and EPINEPHRINE "INJECTION, SOLUTION" INFILTRATION 20100405
ANDA ANDA089646 A-S Medication Solutions LLC EPINEPHRINE; LIDOCAINE H
YDROCHLORIDE ANHYDROUS 10; 20 ug/mL; mg/mL "Amide Local Anesthetic [EPC],Am
ngredient]"
54569-1657_679e834d-2736-4f6b-8639-973efc5943ee 54569-1657 HUMAN PRESCRIPTI
A-S Medication Solutions LLC PHENYLEPHRINE HYDROCHLORIDE 25 mg/mL
"alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA]"
54569-1660_81ccfa6f-ede6-403c-b2cc-c1f59acec649 54569-1660 HUMAN PRESCRIPTI
ON DRUG Marcaine BUPIVACAINE HYDROCHLORIDE "INJECTION, SOLU
TION" EPIDURAL; RETROBULBAR 20090909 NDA NDA016964
A-S Medication Solutions LLC BUPIVACAINE HYDROCHLORIDE 7.5 mg/mL
"
54569-1696_98fd42e2-0796-410f-bec5-6f12e5c44542 54569-1696 HUMAN PRESCRIPTI
ON DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL
DOXEPIN HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC]
54569-1697_f5dcc7cd-f1ab-4ecd-a619-abc45b1f195b 54569-1697 HUMAN PRESCRIPTI
ON DRUG Acetazolamide Acetazolamide TABLET ORAL 19970528
ANDA ANDA040195 A-S Medication Solutions LLC ACETAZOLAMIDE 250
54569-1709_aed3077b-7517-4d32-b5bc-560b8c388412 54569-1709 HUMAN PRESCRIPTI
ANDA ANDA040245 A-S Medication Solutions LLC CARISOPRODOL 350
CIV
54569-1712_b95098c6-c6c7-4a0d-966a-976cee6444ba 54569-1712 HUMAN PRESCRIPTI
UNAPPROVED DRUG OTHER A-S Medication Solutions LLC SALSALATE
750 mg/1
54569-1718_fbdb4c87-d0f8-48a8-89bd-65f2f3bf5ede 54569-1718 HUMAN PRESCRIPTI
ON DRUG Adipex-P Phentermine Hydrochloride TABLET ORAL
54569-1726_76743946-b94a-43b4-8d02-4747e4d95b9b 54569-1726 HUMAN PRESCRIPTI
ANDA ANDA071457 A-S Medication Solutions LLC TEMAZEPAM 30
54569-1729_0fbae59e-bc75-4578-855a-bb318fb15807 54569-1729 HUMAN PRESCRIPTI
ON DRUG BECONASE AQ beclomethasone dipropionate monohydrate "SPRAY,
SUSPENSION" NASAL 19891001 NDA NDA019389 A-S Medi
cation Solutions LLC BECLOMETHASONE DIPROPIONATE MONOHYDRATE 42 ug/1
54569-1746_4a312b66-cbee-4f7a-9094-110854bdd890 54569-1746 HUMAN PRESCRIPTI
ANDA ANDA065271 A-S Medication Solutions LLC AMOXICILLIN 250
54569-1754_420bc858-8e0a-4f5a-86ff-9ee8d63963a4 54569-1754 HUMAN PRESCRIPTI
olutions LLC PROMETHAZINE HYDROCHLORIDE 25 mg/1 "Phenothiazine [
54569-1774_828c65aa-73e8-4c2a-a529-457430f4dd36 54569-1774 HUMAN PRESCRIPTI
54569-1840_9444cb51-4ea1-4b2d-80d9-deee7fd1fbf7 54569-1840 HUMAN PRESCRIPTI
54569-1853_7ce0f8e4-7c0f-4592-825c-eeb2edaa557f 54569-1853 HUMAN PRESCRIPTI
54569-1861_312a9923-f30c-40b2-9a4a-1f06cef7efa4 54569-1861 HUMAN PRESCRIPTI
54569-1873_5cb39f76-5816-402e-8fe4-85ddcbc4ccf3 54569-1873 HUMAN PRESCRIPTI
ON DRUG Betamethasone Valerate betamethasone valerate CREAM TOPICAL
BETAMETHASONE VALERATE 1 mg/g "Corticosteroid [EPC],Corticosteroid Hor
54569-1874_5cb39f76-5816-402e-8fe4-85ddcbc4ccf3 54569-1874 HUMAN PRESCRIPTI
ON DRUG Betamethasone Valerate betamethasone valerate LOTION TOPICAL
BETAMETHASONE VALERATE 1 mg/mL "Corticosteroid [EPC],Corticosteroid Hor
54569-1889_4b61dfe4-4a46-4d41-8fcb-b0de2c1e5359 54569-1889 HUMAN PRESCRIPTI
ON DRUG Dicloxacillin Sodium Dicloxacillin Sodium CAPSULE ORAL
DICLOXACILLIN SODIUM 500 mg/1 "Penicillin-class Antibacterial [EPC],Pe
54569-1899_6202b949-3475-4ac3-9508-c38ba185aca0 54569-1899 HUMAN PRESCRIPTI
ATED, EXTENDED RELEASE" ORAL 19860417 NDA NDA019123
A-S Medication Solutions LLC POTASSIUM CHLORIDE 600 mg/1 "Potassi
54569-1923_23f3b4e8-71a2-47ac-b472-2304c667bf66 54569-1923 HUMAN PRESCRIPTI
LLC LIDOCAINE HYDROCHLORIDE 40 mg/mL "Amide Local Anesthetic [EPC],Am
54569-1970_01fc8c74-fa81-492f-aaba-ab25f62267a5 54569-1970 HUMAN PRESCRIPTI
ON DRUG Chlorzoxazone Chlorzoxazone TABLET ORAL 20110822
ANDA ANDA089859 A-S Medication Solutions LLC CHLORZOXAZONE 500
54569-1983_b8b2b072-2095-4a2c-824a-695804bc4ae4 54569-1983 HUMAN PRESCRIPTI
ANDA ANDA071839 A-S Medication Solutions LLC MINOXIDIL 10
54569-1990_8136d999-b236-4eae-9153-672607d9e3f4 54569-1990 HUMAN PRESCRIPTI
54569-1999_87634807-b086-47d4-a74b-79fbc43a6b9f 54569-1999 HUMAN PRESCRIPTI
olutions LLC TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhib
itor [EPC]
54569-2034_c06105ac-b104-495f-b6d2-03affb97c8de 54569-2034 HUMAN OTC DRUG
Double Antibiotic Bacitracin Zinc and Polymyxin B Sulfate OINTMENT
TOPICAL 20100106 OTC MONOGRAPH FINAL part333B A-S Medi
cation Solutions LLC BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 10000
[USP'U]/g; [USP'U]/g
54569-2053_9422351a-01f6-4ebc-8526-debee0201c44 54569-2053 HUMAN PRESCRIPTI
ON DRUG Cytomel LIOTHYRONINE SODIUM TABLET ORAL 19560508
NDA NDA010379 A-S Medication Solutions LLC LIOTHYRONINE SODIUM
25 ug/1 "l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient]
"
54569-2059_df4f38b3-8dbc-4771-8472-7c61eda1aa63 54569-2059 HUMAN PRESCRIPTI
ON DRUG Diethylpropion HCl Immediate-Release Diethylpropion hydrochlo
ride TABLET ORAL 19590806 NDA NDA011722 A-S Medi
cation Solutions LLC DIETHYLPROPION HYDROCHLORIDE 25 mg/1 "Appetit
rectic [EPC]" CIV
54569-2095_875d94aa-95c3-4df7-932e-344e84c6fa55 54569-2095 HUMAN PRESCRIPTI
ON DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride
olutions LLC CHLORDIAZEPOXIDE HYDROCHLORIDE 25 mg/1 "Benzodiazepine
[EPC],Benzodiazepines [Chemical/Ingredient]" CIV
54569-2113_8868e15d-aaa9-41e8-8605-0f18ee18d98d 54569-2113 HUMAN PRESCRIPTI
ON DRUG ANTIPYRINE AND BENZOCAINE ANTIPYRINE AND BENZOCAINE
OTHER A-S Medication Solutions LLC ANTIPYRINE; BENZOCAINE 54; 14
54569-2131_105736af-018e-408c-8f67-60adbca232cb 54569-2131 HUMAN PRESCRIPTI
ON DRUG Testosterone Cypionate Testosterone Cypionate "INJECTION, SOLU
TION" INTRAMUSCULAR 20110504 ANDA ANDA086030 A-S Medi
cation Solutions LLC TESTOSTERONE CYPIONATE 200 mg/mL "Androgen [EPC],
Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient]" CIII
54569-2140_3e0ee731-5015-4379-a563-1c2e1809c437 54569-2140 HUMAN PRESCRIPTI
ON DRUG Nitrostat nitroglycerin TABLET SUBLINGUAL 20000501
NDA NDA021134 A-S Medication Solutions LLC NITROGLYCERIN 0.4
mg/1 "Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [
PE]"
54569-2148_d951e91f-71ab-4231-8522-efd87b660382 54569-2148 HUMAN PRESCRIPTI
ne Acetonide CREAM TOPICAL 19871222 ANDA ANDA062364
A-S Medication Solutions LLC NYSTATIN; TRIAMCINOLONE ACETONIDE 100000;
1 [USP'U]/g; mg/g "Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient]
"
54569-2154_5a525299-947a-4eec-bf0b-2d0606b8a085 54569-2154 HUMAN OTC DRUG
Nasal Oxymetazoline Hydrochloride SPRAY NASAL 20090317
OTC MONOGRAPH FINAL part341 A-S Medication Solutions LLC OXYMETAZOLINE HY
DROCHLORIDE 5 g/100mL
54569-2163_2893572a-b7fd-449f-9a73-d5caa5e1cb47 54569-2163 HUMAN OTC DRUG
MYTAB For GAS Simethicone "TABLET, CHEWABLE" ORAL 19990312
OTC MONOGRAPH FINAL part332 A-S Medication Solutions LLC DIMETHICONE
80 mg/1
54569-2177_6b167efc-5c32-4ece-9e53-b520c0e37dad 54569-2177 HUMAN PRESCRIPTI
NDA NDA019117 A-S Medication Solutions LLC FLUOCINONIDE 0.5
54569-2198_b9f3d719-0369-4ae0-9a58-abfb1322cdfe 54569-2198 HUMAN PRESCRIPTI
"CAPSULE, EXTENDED RELEASE" ORAL 19770906 NDA NDA01807
4 A-S Medication Solutions LLC PHENDIMETRAZINE TARTRATE 105
imetic Amine Anorectic [EPC]" CIII
54569-2199_2dae1992-a9eb-4590-b74c-958e9f33a822 54569-2199 HUMAN PRESCRIPTI
54569-2215_05ef31fe-54fd-4003-a97f-92b6328d389b 54569-2215 HUMAN PRESCRIPTI
ON DRUG Lidocaine Hydrochloride and Epinephrine LIDOCAINE HYDROCHLORIDE
ANHYDROUS and EPINEPHRINE "INJECTION, SOLUTION" INFILTRATION 20100405
ANDA ANDA089644 A-S Medication Solutions LLC EPINEPHRINE; LIDOCAINE H
YDROCHLORIDE ANHYDROUS 10; 10 ug/mL; mg/mL "Amide Local Anesthetic [EPC],Am
ngredient]"
54569-2222_7ba0ea13-909a-462d-97bc-efc087450111 54569-2222 HUMAN PRESCRIPTI
LLC WATER 1 mL/mL
54569-2275_0c92f1c1-3b09-44ad-a457-6ab878533b51 54569-2275 HUMAN PRESCRIPTI
54569-2281_5e52aff0-3a49-4bfb-8a0b-b0c29a318089 54569-2281 HUMAN PRESCRIPTI
ON DRUG ERYTHROMYCIN Erythromycin "CAPSULE, DELAYED RELEASE"
LLC ERYTHROMYCIN 250 mg/1 "Decreased Sebaceous Gland Activity [PE]
54569-2285_711b937a-db77-4333-b1a5-debc27a16021 54569-2285 HUMAN PRESCRIPTI
olutions LLC DEXAMETHASONE; TOBRAMYCIN 1; 3 mg/mL; mg/mL "Aminogl
54569-2295_4638c51e-5d71-4ae5-9233-50adb0e38cea 54569-2295 HUMAN OTC DRUG
triple antibiotic "bacitracin, neomycin, polymyxin B" OINTMENT
cation Solutions LLC BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g
54569-2299_6d2890cf-8162-4085-9fe6-0e598c5ee539 54569-2299 HUMAN PRESCRIPTI
ANDA ANDA089682 A-S Medication Solutions LLC HYDROCORTISONE 25
54569-2311_a7a40f17-0363-4b63-8c7f-98ec3a41aa6e 54569-2311 HUMAN PRESCRIPTI
ON DRUG acetic acid acetic acid SOLUTION AURICULAR (OTIC)
ACETIC ACID 20.65 mg/mL
54569-2353_e6775ed6-5cdd-4c27-bc8c-64df4334594e 54569-2353 HUMAN PRESCRIPTI
Antagonists [MoA]"
54569-2376_cf836a1d-a69e-4a61-8a56-6f79827c069c 54569-2376 HUMAN PRESCRIPTI
ON DRUG Flurazepam Flurazepam Hydrochloride CAPSULE ORAL
FLURAZEPAM HYDROCHLORIDE 15 mg/1 "Benzodiazepine [EPC],Benzodiaze
54569-2385_bc43f09d-e61a-4cdf-a514-890d61452359 54569-2385 HUMAN OTC DRUG
DocQLace docusate sodium CAPSULE ORAL 20110801
OTC MONOGRAPH NOT FINAL part334 A-S Medication Solutions LLC DOCUSATE SODIUM
100 mg/1
54569-2391_33b00a3a-7331-4e3c-b88d-35506bd79260 54569-2391 HUMAN PRESCRIPTI
ON DRUG NEO-POLYCIN NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN
ZINC OINTMENT OPHTHALMIC 20110715 ANDA ANDA0607
64 A-S Medication Solutions LLC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYM
YXIN B SULFATE 400; 3.5; 10000 U/g; mg/g; U/g "Aminoglycoside Antibacterial [E
PC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Po
lymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE]"
54569-2409_bd27d628-d5a8-44fb-8a47-59f9cb40a082 54569-2409 HUMAN OTC DRUG
OTC MONOGRAPH FINAL part333B A-S Medication Solutions LLC BACITRAC
54569-2411_5425a7ce-4cba-48dd-92cd-2c52d155546b 54569-2411 HUMAN PRESCRIPTI
ON DRUG Ampicillin Ampicillin CAPSULE ORAL 19880225
ANDA ANDA062882 A-S Medication Solutions LLC AMPICILLIN TRIHYDRATE
500 mg/1 "Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingr
edient]"
54569-2433_a696a730-3da7-4586-9b30-4e4f3ea6c27f 54569-2433 HUMAN PRESCRIPTI
ON DRUG Erythromycin Base Erythromycin "TABLET, FILM COATED" ORAL
54569-2452_ea3733d2-2002-4b71-9646-6128dae8b3ca 54569-2452 HUMAN PRESCRIPTI
ON DRUG Triamcinolone Acetonide Triamcinolone Acetonide OINTMENT
LLC TRIAMCINOLONE ACETONIDE 0.25 mg/g
54569-2483_cbda0f5a-2860-4ef2-8a9a-9713f8612f74 54569-2483 HUMAN PRESCRIPTI
LLC THEOPHYLLINE ANHYDROUS 300 mg/1 "Methylxanthine [EPC],Xanthines
54569-2502_a696a730-3da7-4586-9b30-4e4f3ea6c27f 54569-2502 HUMAN PRESCRIPTI
ON DRUG Erythromycin Base Erythromycin "TABLET, FILM COATED" ORAL
54569-2507_cf56ce90-c1b9-4e30-bb5e-7031e9adf47b 54569-2507 HUMAN PRESCRIPTI
ON DRUG ERYTHROMYCIN ETHYLSUCCINATE Erythromycin Ethylsuccinate
olutions LLC ERYTHROMYCIN ETHYLSUCCINATE 400 mg/1 "Decreased Sebac
54569-2509_5eab2d40-eedb-4b8b-a0c9-d757845c1af8 54569-2509 HUMAN PRESCRIPTI
ON DRUG Isoniazid Isoniazid TABLET ORAL 19720901
ANDA ANDA080937 A-S Medication Solutions LLC ISONIAZID 300
mg/1 Antimycobacterial [EPC]
54569-2523_3c525ad3-8ccb-4310-b385-79bed00a62ba 54569-2523 HUMAN PRESCRIPTI
54569-2538_7000b295-7980-4196-acdd-b7656ac9e3d2 54569-2538 HUMAN PRESCRIPTI
ON DRUG "Butalbital, Acetaminophen and Caffeine" "Butalbital, Ace
ANDA040511 A-S Medication Solutions LLC ACETAMINOPHEN; BUTALBITAL; CAFFE
INE 325; 50; 40 mg/1; mg/1; mg/1 "Barbiturate [EPC],Barbiturates
[Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous Sys
tem Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient]"
54569-2545_4c215882-ae94-4a2d-9ec1-7b9e8a6f0785 54569-2545 HUMAN PRESCRIPTI
A-S Medication Solutions LLC HYDROCHLOROTHIAZIDE; TRIAMTERENE 50; 75
54569-2556_65821270-1506-4867-8511-0a6fb0e7e691 54569-2556 HUMAN PRESCRIPTI
CREAM TOPICAL 19840626 NDA NDA019137 A-S Medication S
54569-2571_e6775ed6-5cdd-4c27-bc8c-64df4334594e 54569-2571 HUMAN PRESCRIPTI
Antagonists [MoA]"
54569-2586_a31b5d08-e78b-4965-8a70-d2e5f303dfd7 54569-2586 HUMAN PRESCRIPTI
ON DRUG Hydrocortisone Acetate HYDROCORTISONE ACETATE SUPPOSITORY
RECTAL 19900701 UNAPPROVED DRUG OTHER A-S Medication S
olutions LLC HYDROCORTISONE ACETATE 25 mg/1 "Corticosteroid [EPC],Co
54569-2590_b033a6b4-95a1-4338-8f63-7bc4c6d7a443 54569-2590 HUMAN PRESCRIPTI
ON DRUG TobraDex tobramycin and dexamethasone OINTMENT
olutions LLC DEXAMETHASONE; TOBRAMYCIN 1; 3 mg/g; mg/g "Aminogl
54569-2594_6e3c0223-0080-425a-ae04-d8d6ee6dedcf 54569-2594 HUMAN OTC DRUG
Eye Irrigating Purified Water SOLUTION OPHTHALMIC 20111007
UNAPPROVED DRUG OTHER A-S Medication Solutions LLC WATER 99.05
mL/100mL
54569-2619_67e46388-7259-43f8-9485-b7401b933e16 54569-2619 HUMAN PRESCRIPTI
ON DRUG ELOCON Mometasone Furoate CREAM TOPICAL 19870506
NDA NDA019625 A-S Medication Solutions LLC MOMETASONE FUROATE
MoA],Corticosteroid Hormone Receptor Agonists [MoA]"
54569-2655_b14966f1-24d0-4785-a481-01efaf8c2c29 54569-2655 HUMAN PRESCRIPTI
ANDA ANDA074649 A-S Medication Solutions LLC CARBAMAZEPINE 200
oA]"
54569-2657_5b66594f-d7a1-4943-92e4-1e50361175c4 54569-2657 HUMAN PRESCRIPTI
ON DRUG Naphazoline Naphazoline Hydrochloride SOLUTION/ DROPS
olutions LLC NAPHAZOLINE HYDROCHLORIDE 1 mg/mL
54569-2668_6792cf82-493e-48bd-ab89-858e50a95eb4 54569-2668 HUMAN PRESCRIPTI
olutions LLC PHENDIMETRAZINE TARTRATE 35 mg/1 "Appetite Suppre
EPC]" CIII
ANDA ANDA072926 A-S Medication Solutions LLC LORAZEPAM 0.5
54569-2702_696eeae8-2240-46b9-a0ea-3ead346494ca 54569-2702 HUMAN PRESCRIPTI
ON DRUG Penicillin V Potassium Penicillin V Potassium "TABLET, FILM CO
olutions LLC PENICILLIN V POTASSIUM 250 mg/1
54569-2710_ceddb186-5e47-4e4f-b173-c58be7fb4030 54569-2710 HUMAN PRESCRIPTI
olutions LLC PENICILLIN V POTASSIUM 500 mg/1
54569-2765_2adcb8f1-abbc-45c2-9fa0-4ee552e4c560 54569-2765 HUMAN PRESCRIPTI
ON DRUG Cytotec misoprostol TABLET ORAL 19861227
NDA NDA019268 A-S Medication Solutions LLC MISOPROSTOL 200
redient]"
54569-2784_2d8ad8ad-3d20-4ba1-9dab-e2f300543972 54569-2784 HUMAN PRESCRIPTI
ON DRUG Atropine Sulfate Atropine Sulfate SOLUTION
OPHTHALMIC 19900930 UNAPPROVED DRUG OTHER A-S Medi
cation Solutions LLC ATROPINE SULFATE 10 mg/mL "Anticholinergic
54569-2801_f34ff3dd-ab83-4d04-b0bc-1d9deab95401 54569-2801 HUMAN PRESCRIPTI
ON DRUG clonidine hydrochloride Clonidine Hydrochloride TABLET ORAL
54569-2861_8b27a5a9-e2d7-40f4-93ee-d5fb08faef4d 54569-2861 HUMAN PRESCRIPTI
ON DRUG SUPRAX cefixime TABLET ORAL 20080401
ANDA ANDA065130 A-S Medication Solutions LLC CEFIXIME 400
54569-2864_db738906-04aa-48f9-aa21-79d3466e9f3b 54569-2864 HUMAN OTC DRUG
Dimenhydrinate Dimenhydrinate TABLET ORAL 20040301
OTC MONOGRAPH FINAL part336 A-S Medication Solutions LLC DIMENHYDRINATE
50 mg/1
54569-2867_f17e6806-1774-4a23-81cf-45e6d6d76346 54569-2867 HUMAN PRESCRIPTI
ON DRUG Polytrim polymyxin b sulfate and trimethoprim sulfate
A-S Medication Solutions LLC POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE
100000; 1 [USP'U]/mL; mg/mL "Polymyxin-class Antibacterial [EPC],Pol
ymyxins [Chemical/Ingredient],Dihydrofolate Reductase Inhibitor Antibacterial [E
PC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA
],Organic Cation Transporter 2 Inhibitors [MoA]"
54569-2868_9ae06f62-3989-4387-bcc9-d337c6d38882 54569-2868 HUMAN PRESCRIPTI
olutions LLC PREDNISOLONE ACETATE 10 mg/mL "Corticosteroid [EPC],Co
54569-2900_5d7676a3-bc57-426d-a25b-50669d74cb97 54569-2900 HUMAN PRESCRIPTI
ON DRUG Isoniazid isoniazid SOLUTION ORAL 19831111
mg/5mL Antimycobacterial [EPC]
54569-2918_8e7cb87c-79c5-46d0-88b7-5ccb6b66dd87 54569-2918 HUMAN OTC DRUG
Novolin 70/30 Human Insulin "INJECTION, SUSPENSION" SUBCUTANEOUS 19910625
NDA NDA019991 A-S Medication Solutions LLC INSULIN HUMAN 100
[USP'U]/mL
54569-2928_ada15ddb-c5d6-40fc-a06e-c142d5c7dc64 54569-2928 HUMAN PRESCRIPTI
54569-2929_edbfbad4-8b9e-46fa-b491-b506c7254b5f 54569-2929 HUMAN PRESCRIPTI
54569-2930_4e02dc5d-36c0-48a7-9d0f-6f6ff58cb8f2 54569-2930 HUMAN PRESCRIPTI
54569-2931_a474c1d3-ed38-41f7-b5ef-f1ade316f006 54569-2931 HUMAN PRESCRIPTI
54569-2933_166ab686-97b8-4508-9c9a-b788ca7616b4 54569-2933 HUMAN PRESCRIPTI
ON DRUG Penicillin V Potassium Penicillin V Potassium "POWDER, FOR SOL
UTION" ORAL 19900930 ANDA ANDA060456 A-S Medication S
olutions LLC PENICILLIN V POTASSIUM 250 mg/5mL
54569-2935_189950fe-e593-48ca-bfac-bf4f4ffccdf4 54569-2935 HUMAN PRESCRIPTI
ON DRUG Penicillin V Potassium Penicillin V Potassium "POWDER, FOR SOL
UTION" ORAL 19900930 ANDA ANDA060456 A-S Medication S
olutions LLC PENICILLIN V POTASSIUM 250 mg/5mL
54569-2942_5eab2d40-eedb-4b8b-a0c9-d757845c1af8 54569-2942 HUMAN PRESCRIPTI
mg/1 Antimycobacterial [EPC]
54569-2954_280902d9-cd3d-4b85-a80d-972d1c6b3dfa 54569-2954 HUMAN PRESCRIPTI
54569-2968_9422351a-01f6-4ebc-8526-debee0201c44 54569-2968 HUMAN PRESCRIPTI
ON DRUG Cytomel LIOTHYRONINE SODIUM TABLET ORAL 19560508
NDA NDA010379 A-S Medication Solutions LLC LIOTHYRONINE SODIUM
5 ug/1 "l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient]
"
54569-2996_2a1d432b-5efb-4292-aa0c-f4d689078a02 54569-2996 HUMAN OTC DRUG
Hibiclens Chlorhexidine gluconate SOLUTION TOPICAL 19760917
NDA NDA017768 A-S Medication Solutions LLC CHLORHEXIDINE GLUCONATE
213 g/1000mL
54569-3043_0f00f49e-0ece-4771-92fd-23b776dc1d86 54569-3043 HUMAN PRESCRIPTI
mg/1
EPC]" CIV
54569-3070_7e5edcf6-c8e2-4fd9-9f6c-534e52341b00 54569-3070 HUMAN PRESCRIPTI
ON DRUG Myambutol Ethambutol hydrochloride "TABLET, FILM CO
ATED" ORAL 20070810 NDA NDA016320 A-S Medication S
olutions LLC ETHAMBUTOL HYDROCHLORIDE 400 mg/1 Antimycobacteria
l [EPC]
54569-3074_63b49d29-638b-4c0c-9066-f8b8b6e155cb 54569-3074 HUMAN PRESCRIPTI
54569-3121_b672aab0-d7be-4213-9214-107638162c63 54569-3121 HUMAN PRESCRIPTI
LLC NIFEDIPINE 10 mg/1 "Calcium Channel Antagonists [MoA],Dihyd
54569-3146_ec13b5cb-c30f-4a40-b095-fae58eb90fb1 54569-3146 HUMAN OTC DRUG
Cheratussin AC codeine phosphate and guaifenesin LIQUID ORAL
LLC CODEINE PHOSPHATE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL CV
54569-3176_1dbe4af8-a988-44c9-9b06-cef59281f8f2 54569-3176 HUMAN PRESCRIPTI
ON DRUG VITAMIN D ergocalciferol CAPSULE ORAL 20100315
ANDA ANDA040865 A-S Medication Solutions LLC ERGOCALCIFEROL 1.25
54569-3177_953ec994-3268-4e6c-a75a-abb3137125d8 54569-3177 HUMAN OTC DRUG
Q Tussin DM Dextromethorphan HBr and Guaifenesin SYRUP ORAL
LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL
54569-3195_8a850bff-faac-4938-8c90-af6692b5b225 54569-3195 HUMAN PRESCRIPTI
ON DRUG Terazol 3 TERCONAZOLE CREAM VAGINAL 19910221
NDA NDA019964 A-S Medication Solutions LLC TERCONAZOLE 8
mg/g "Azole Antifungal [EPC],Azoles [Chemical/Ingredient]"
54569-3203_90e7fdd5-4214-4dc0-a941-3b42bae541bc 54569-3203 HUMAN PRESCRIPTI
olutions LLC PHENTERMINE HYDROCHLORIDE 37.5 mg/1 "Appetite Suppre
EPC]" CIV
54569-3259_dc3f4093-c45d-4edc-9249-e87fee7af6ec 54569-3259 HUMAN PRESCRIPTI
ON DRUG Neomycin and Polymyxin B Sulfates and Hydrocortisone "Neomyci
n sulfate, Polymyxin B Sulfate and Hydrocortisone" SUSPENSION/ DROPS
AURICULAR (OTIC) 19960828 ANDA ANDA064065 A-S Medi
cation Solutions LLC HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
10; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL "Corticosteroid [EPC],Corticoste
roid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminogly
cosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Ch
emical/Ingredient]"
54569-3265_bc1bf9e6-053c-43b3-aa6b-19f89f417d5d 54569-3265 HUMAN PRESCRIPTI
ANDA077002 A-S Medication Solutions LLC DIGOXIN 125 ug/1 "Cardiac
54569-3285_a9c3bd97-aa7a-4af1-91bd-9fee3bbc2b99 54569-3285 HUMAN OTC DRUG
Pepto-Bismol Bismuth subsalicylate LIQUID ORAL 19890331
OTC MONOGRAPH FINAL part335 A-S Medication Solutions LLC BISMUTH SUBSALIC
YLATE 525 mg/30mL
54569-3302_fc90f160-ea14-4466-8023-b3c232ab4f9e 54569-3302 HUMAN PRESCRIPTI
mg/1
54569-3322_892c91ab-76ba-4e91-ab3f-1ecae0ec927e 54569-3322 HUMAN PRESCRIPTI
CIII
54569-3324_d4e31041-75ae-4969-998d-b6864a952614 54569-3324 HUMAN PRESCRIPTI
54569-3332_df5bbd61-5f99-47b9-b83b-e227ed5b9f48 54569-3332 HUMAN PRESCRIPTI
54569-3335_e08699c1-3712-46ab-bc01-9d391eb37c4b 54569-3335 HUMAN PRESCRIPTI
54569-3341_1e1856e5-811e-4185-bd2d-d82ab7f07be2 54569-3341 HUMAN PRESCRIPTI
n Sulfate, Polymyxin B Sulfate, Hydrocortisone" SOLUTION/ DROPS AURICULAR (OTIC)
HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 10; 3.5; 10000 mg/mL; m
g/mL; [USP'U]/mL "Aminoglycoside Antibacterial [EPC],Aminoglycosides [Che
mical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingre
dient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]"
54569-3354_31148775-8392-4cad-a736-546dc45e7c42 54569-3354 HUMAN PRESCRIPTI
]"
54569-3372_635c3d5b-c8ce-4f1d-a97b-b9cc203850b6 54569-3372 HUMAN PRESCRIPTI
ON DRUG Multi Vitamin with Fluoride Multi Vitamin with Fluoride
"TABLET, CHEWABLE" ORAL 20091009 UNAPPROVED DRUG OTHER
A-S Medication Solutions LLC ".ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID;
CHOLECALCIFEROL; CYANOCOBALAMIN; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLOR
IDE; RIBOFLAVIN; SODIUM ASCORBATE; SODIUM FLUORIDE; THIAMINE MONONITRATE; VITAMI
N A ACETATE" 15; 24; 400; 4.5; .3; 13.5; 1.05; 1.2; 36; .5; 1.05; 2500
[iU]/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1
"Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient]
,Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC]"
54569-3394_7de681d5-b4f4-40a5-802a-4f08d36e1f60 54569-3394 HUMAN PRESCRIPTI
ON DRUG Nizoral ketoconazole SHAMPOO TOPICAL 19900831
NDA NDA019927 A-S Medication Solutions LLC KETOCONAZOLE 20
mg/mL "Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4
[MoA]"
54569-3398_4df4898e-c86e-4fa5-88b2-b8530301ec06 54569-3398 HUMAN OTC DRUG
triple antibiotic "bacitracin, neomycin, polymyxin B" OINTMENT
cation Solutions LLC BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g
54569-3403_0173aeef-5ee4-4ac8-ab97-ee8a085e20a5 54569-3403 HUMAN PRESCRIPTI
ANDA ANDA040245 A-S Medication Solutions LLC CARISOPRODOL 350
CIV
54569-3405_92779a56-0b70-4d34-9853-d4be2ccc994d 54569-3405 HUMAN OTC DRUG
Acne Medication 10 Benzoyl Peroxide GEL TOPICAL 20121029
OTC MONOGRAPH FINAL part333D A-S Medication Solutions LLC BENZOYL
PEROXIDE 100 mg/g
54569-3406_82352374-88dd-4531-b51f-a41769eac665 54569-3406 HUMAN OTC DRUG
Acne Medication 5 Benzoyl Peroxide GEL TOPICAL 20121029
OTC MONOGRAPH FINAL part333D A-S Medication Solutions LLC BENZOYL
PEROXIDE 50 mg/g
54569-3413_34487f13-b1d5-4c72-a92d-68c3e8370bef 54569-3413 HUMAN PRESCRIPTI
mg/1
54569-3439_6f157348-07b1-435d-936e-18aeaf516b17 54569-3439 HUMAN PRESCRIPTI
NDA NDA050662 A-S Medication Solutions LLC CLARITHROMYCIN 500
mg/1 "Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochro
me P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein
Inhibitors [MoA]"
54569-3456_cbe5569e-2563-4706-8b6b-4f3a9df99831 54569-3456 HUMAN PRESCRIPTI
ON DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride
olutions LLC CLINDAMYCIN HYDROCHLORIDE 150 mg/1 "Decreased Sebac
Ingredient]"
54569-3473_76750aa6-39d0-4981-ac05-c1d0ce8c8ff3 54569-3473 HUMAN PRESCRIPTI
ON DRUG Triamcinolone Acetonide Triamcinolone Acetonide PASTE TOPICAL
54569-3504_35ab0b00-751f-4a65-ba44-663041baf1d9 54569-3504 HUMAN OTC DRUG
54569-3570_8eabc230-741d-4a7e-b115-a9a44d99558f 54569-3570 HUMAN PRESCRIPTI
ON DRUG AK-POLY-BAC Bacitracin Zinc and Polymyxin B Sulfate OINTMENT
olutions LLC BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 10000 [USP'U]/
g; [USP'U]/g "Decreased Cell Wall Synthesis & Repair [PE],Polymyxin-class
Antibacterial [EPC],Polymyxins [Chemical/Ingredient]"
54569-3658_0cda98e1-3749-480d-8705-872b8be79a50 54569-3658 HUMAN PRESCRIPTI
ON DRUG Diflunisal Diflunisal "TABLET, FILM COATED" ORAL
DIFLUNISAL 500 mg/1 "Cyclooxygenase Inhibitors [MoA],Nonsteroidal An
rug [EPC]"
54569-3667_4f97a4e0-9e5c-42bd-87cc-ea9cfd77a200 54569-3667 HUMAN PRESCRIPTI
olutions LLC DILTIAZEM HYDROCHLORIDE 60 mg/1 "Calcium Channel Antagon
54569-3688_fb6e7359-23f8-4673-b66e-d428f067c7dc 54569-3688 HUMAN PRESCRIPTI
ANDA ANDA073517 A-S Medication Solutions LLC KETOPROFEN 75
54569-3689_edbfbad4-8b9e-46fa-b491-b506c7254b5f 54569-3689 HUMAN PRESCRIPTI
ON DRUG Amoxicillin Amoxicillin "TABLET, CHEWABLE" ORAL
54569-3693_8625d9b4-26fe-4880-be22-2dd40f4e28a7 54569-3693 HUMAN PRESCRIPTI
ANDA ANDA074118 A-S Medication Solutions LLC PIROXICAM 20
54569-3695_c72571ee-15d7-4606-886b-a6811e1ebec9 54569-3695 HUMAN PRESCRIPTI
ON DRUG Gemfibrozil Gemfibrozil TABLET ORAL 20110101
ANDA ANDA077836 A-S Medication Solutions LLC GEMFIBROZIL 600
54569-3701_d960db5c-1a70-4bca-a5d1-ee01813f2e18 54569-3701 HUMAN PRESCRIPTI
ON DRUG Depo-Provera medroxyprogesterone acetate "INJECTION, SUSP
ENSION" INTRAMUSCULAR 19921029 NDA NDA020246 A-S Medi
cation Solutions LLC MEDROXYPROGESTERONE ACETATE 150 mg/mL "Progest
54569-3707_0686b63f-0188-40e5-b7b0-476c138eaf9c 54569-3707 HUMAN PRESCRIPTI
ON DRUG Loperamide Hydrochloride Loperamide Hydrochloride
olutions LLC LOPERAMIDE HYDROCHLORIDE 2 mg/1 "Opioid Agonist
[EPC],Opioid Agonists [MoA]"
54569-3755_2c481e99-95e0-45dd-bf46-f7825c0637f4 54569-3755 HUMAN PRESCRIPTI
ON DRUG Alprazolam alprazolam TABLET ORAL 20080925
ANDA ANDA078491 A-S Medication Solutions LLC ALPRAZOLAM 0.25
ANDA ANDA078491 A-S Medication Solutions LLC ALPRAZOLAM 0.5
54569-3807_b078dacc-3369-43d3-b263-415b1a136281 54569-3807 HUMAN PRESCRIPTI
olutions LLC MEDROXYPROGESTERONE ACETATE 5 mg/1 "Progesterone Co
54569-3827_ed68c40d-ba70-4919-9a7d-812090e5a1cf 54569-3827 HUMAN PRESCRIPTI
ON DRUG Ambien zolpidem tartrate "TABLET, FILM COATED" ORAL
54569-3828_ed68c40d-ba70-4919-9a7d-812090e5a1cf 54569-3828 HUMAN PRESCRIPTI
ON DRUG Ambien zolpidem tartrate "TABLET, FILM COATED" ORAL
54569-3887_f0607739-5b18-48f9-a7f4-af7ef2485b84 54569-3887 HUMAN PRESCRIPTI
54569-3899_b4f79d6d-6721-4079-b48d-88f55a1219da 54569-3899 HUMAN PRESCRIPTI
INTRABRONCHIAL 20101104 ANDA ANDA077839 A-S Medication S
olutions LLC ALBUTEROL SULFATE 2.5 mg/3mL "Adrenergic beta2-Agonis
ts [MoA],beta2-Adrenergic Agonist [EPC]"
54569-3901_7ac8ec2a-4159-485f-a61e-e7988a2e522e 54569-3901 HUMAN PRESCRIPTI
ON DRUG CEFACLOR CEFACLOR CAPSULE ORAL 20070501
ANDA ANDA065350 A-S Medication Solutions LLC CEFACLOR 250
54569-3902_7ac8ec2a-4159-485f-a61e-e7988a2e522e 54569-3902 HUMAN PRESCRIPTI
ON DRUG CEFACLOR CEFACLOR CAPSULE ORAL 20070501
ANDA ANDA065350 A-S Medication Solutions LLC CEFACLOR 500
54569-3909_892c91ab-76ba-4e91-ab3f-1ecae0ec927e 54569-3909 HUMAN PRESCRIPTI
oA]" CIII
54569-3911_03138e1f-cf5c-499f-8694-07f10dcd345c 54569-3911 HUMAN PRESCRIPTI
oA]" CIII
54569-3912_7f29ad1b-ea80-4485-bbac-f7101aee0705 54569-3912 HUMAN PRESCRIPTI
ON DRUG Brevital Sodium methohexital sodium "INJECTION, POWDER, LYOP
HILIZED, FOR SOLUTION" INTRAMUSCULAR; INTRAVENOUS; RECTAL 20071101
NDA NDA011559 A-S Medication Solutions LLC METHOHEXITAL SODIUM
500 mg/1 "Barbiturate [EPC],Barbiturates [Chemical/Ingredient]" CIV
54569-3966_00b6b1de-85df-4e29-852a-905852ffc9ac 54569-3966 HUMAN PRESCRIPTI
ON DRUG Triazolam triazolam TABLET ORAL 19821115
NDA AUTHORIZED GENERIC NDA017892 A-S Medication Solutions LLC TRIAZOLA
nt]" CIV
54569-4026_fc90f160-ea14-4466-8023-b3c232ab4f9e 54569-4026 HUMAN PRESCRIPTI
mg/1
54569-4048_680d90a9-70ea-4bdd-932c-bf699cba96cf 54569-4048 HUMAN PRESCRIPTI
EPC]" CIV
54569-4168_f94ba15b-24b3-44bf-8695-fc52b703824a 54569-4168 HUMAN PRESCRIPTI
olutions LLC PROMETHAZINE HYDROCHLORIDE 25 mg/1 "Phenothiazine [
54569-4197_77279f2b-ac6f-4908-9327-f74bd2fd2a6d 54569-4197 HUMAN OTC DRUG
Qdryl Allergy Diphenhydramine Hydrochloride SOLUTION ORAL
LLC DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL
54569-4210_6b167efc-5c32-4ece-9e53-b520c0e37dad 54569-4210 HUMAN PRESCRIPTI
ON DRUG Fluocinonide Fluocinonide OINTMENT TOPICAL 19990630
ANDA ANDA075008 A-S Medication Solutions LLC FLUOCINONIDE 0.5
54569-4272_03138e1f-cf5c-499f-8694-07f10dcd345c 54569-4272 HUMAN PRESCRIPTI
CIII
54569-4325_afd5ec91-5195-4e9e-af9c-e0434e137728 54569-4325 HUMAN PRESCRIPTI
ON DRUG AUGMENTIN amoxicillin and clavulanate potassium "TABLET,
FILM COATED" ORAL 19961002 NDA NDA050720 A-S Medi
cation Solutions LLC AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125
mg/1; 1/1 "Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingr
edient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]"
54569-4336_480e7f7a-4008-419e-9acc-c34854bedd1a 54569-4336 HUMAN PRESCRIPTI
EPC]" CIII
54569-4347_3c59bf59-29e3-4412-85ed-32bab4ea519e 54569-4347 HUMAN PRESCRIPTI
ON DRUG Lortab hydrocodone bitartrate and acetaminophen TABLET
LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 10 mg/1; mg/1 "Opioid
54569-4387_5b7486cb-62a0-480c-8f01-f9753bc2d7e0 54569-4387 HUMAN PRESCRIPTI
ON DRUG Acetazolamide Acetazolamide TABLET ORAL 19970528
ANDA ANDA040195 A-S Medication Solutions LLC ACETAZOLAMIDE 125
54569-4391_f27db70d-b07d-488f-805e-63d97ca2f294 54569-4391 HUMAN PRESCRIPTI
ANDA ANDA065392 A-S Medication Solutions LLC CEFADROXIL 500
54569-4400_ccf4d014-f102-4ed2-8c88-d1d5162873c1 54569-4400 HUMAN PRESCRIPTI
olutions LLC DEXAMETHASONE; TOBRAMYCIN 1; 3 mg/mL; mg/mL "Aminogl
54569-4466_95658014-d74c-41d4-815a-029f91ec6b2e 54569-4466 HUMAN PRESCRIPTI
ON DRUG Lipitor atorvastatin calcium "TABLET, FILM COATED" ORAL
E" 90 mg/1
54569-4586_5e2b23b4-3dc1-490f-8a3c-9ab7ee82c8a4 54569-4586 HUMAN PRESCRIPTI
ON DRUG Clorazepate Dipotassium Clorazepate Dipotassium TABLET ORAL
CLORAZEPATE DIPOTASSIUM 15 mg/1 "Benzodiazepine [EPC],Benzodiazepines [C
54569-4605_29277dbb-5cd8-4e31-b99a-977a6fca2ee6 54569-4605 HUMAN PRESCRIPTI
ON DRUG SINGULAIR montelukast sodium "TABLET, FILM COATED"
LLC MONTELUKAST SODIUM 10 mg/1 "Leukotriene Receptor Antagonist
54569-4614_680d90a9-70ea-4bdd-932c-bf699cba96cf 54569-4614 HUMAN PRESCRIPTI
ANDA ANDA078491 A-S Medication Solutions LLC ALPRAZOLAM 1
54569-4671_b1fca7bd-79f2-432e-aafe-0a54bc83dec8 54569-4671 HUMAN PRESCRIPTI
NDA NDA020998 A-S Medication Solutions LLC CELECOXIB 100
54569-4672_b1fca7bd-79f2-432e-aafe-0a54bc83dec8 54569-4672 HUMAN PRESCRIPTI
NDA NDA020998 A-S Medication Solutions LLC CELECOXIB 200
54569-4700_230de062-4386-4ae4-b6d5-da1035f17df1 54569-4700 HUMAN PRESCRIPTI
ON DRUG Plavix clopidogrel bisulfate "TABLET, FILM COATED" ORAL
ON DRUG SINGULAIR montelukast sodium "TABLET, CHEWABLE"
54569-4737_318b3c4f-be36-4ca1-bd85-acaa33565455 54569-4737 HUMAN PRESCRIPTI
ON DRUG CEFTIN cefuroxime axetil "POWDER, FOR SUSPENSION"
LLC CEFUROXIME AXETIL 250 mg/5mL "Cephalosporin Antibacterial [EP
54569-4742_ef98c8b4-41d2-4bbe-b1c2-ae36e89e699e 54569-4742 HUMAN PRESCRIPTI
ON DRUG Xenical orlistat CAPSULE ORAL 20101217
NDA NDA020766 A-S Medication Solutions LLC ORLISTAT 120
mg/1 "Intestinal Lipase Inhibitor [EPC],Lipase Inhibitors [MoA]"
54569-4768_5d26352b-5e73-4bb6-bc47-4c0999f12cbc 54569-4768 HUMAN PRESCRIPTI
ON DRUG Flomax tamsulosin hydrochloride CAPSULE ORAL 19990603
NDA NDA020579 A-S Medication Solutions LLC TAMSULOSIN HYDROCHLORIDE
0.4 mg/1 "Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EP
C]"
54569-4781_828c65aa-73e8-4c2a-a529-457430f4dd36 54569-4781 HUMAN PRESCRIPTI
54569-4816_90e7fdd5-4214-4dc0-a941-3b42bae541bc 54569-4816 HUMAN PRESCRIPTI
EPC]" CIV
54569-4900_6ada4251-188d-4fe6-9e78-7d330418c5ab 54569-4900 HUMAN PRESCRIPTI
ANDA ANDA090248 A-S Medication Solutions LLC ALPRAZOLAM 2
54569-4904_d960db5c-1a70-4bca-a5d1-ee01813f2e18 54569-4904 HUMAN PRESCRIPTI
ON DRUG Depo-Provera medroxyprogesterone acetate "INJECTION, SUSP
ENSION" INTRAMUSCULAR 19921029 NDA NDA020246 A-S Medi
cation Solutions LLC MEDROXYPROGESTERONE ACETATE 150 mg/mL "Progest
54569-4953_6f157348-07b1-435d-936e-18aeaf516b17 54569-4953 HUMAN PRESCRIPTI
ON DRUG Biaxin Clarithromycin "TABLET, FILM COATED, EXTENDED RELEASE"
LLC CLARITHROMYCIN 500 mg/1 "Macrolide Antimicrobial [EPC],Macrolide
s [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A
54569-5116_f90a7fbe-800b-4f62-ba0d-565e46db4f48 54569-5116 HUMAN PRESCRIPTI
ON DRUG Midazolam Hydrochloride MIDAZOLAM HYDROCHLORIDE "INJECTION, SOLU
93 A-S Medication Solutions LLC MIDAZOLAM HYDROCHLORIDE 5 mg/mL
54569-5126_b6616836-17a3-4ef9-b3f9-e805d4d25e48 54569-5126 HUMAN PRESCRIPTI
ANDA ANDA077856 A-S Medication Solutions LLC CLONAZEPAM 1
ON DRUG SINGULAIR montelukast sodium "TABLET, CHEWABLE"
54569-5182_4e02dc5d-36c0-48a7-9d0f-6f6ff58cb8f2 54569-5182 HUMAN PRESCRIPTI
54569-5193_41c8d503-82bb-4504-975a-dc7379310c71 54569-5193 HUMAN PRESCRIPTI
54569-5195_480e7f7a-4008-419e-9acc-c34854bedd1a 54569-5195 HUMAN PRESCRIPTI
EPC]" CIII
54569-5224_dd597813-b1ef-4216-9bbc-b850cfd5acea 54569-5224 HUMAN PRESCRIPTI
EPC]" CIV
ANDA ANDA077856 A-S Medication Solutions LLC CLONAZEPAM 0.5
54569-5233_6792cf82-493e-48bd-ab89-858e50a95eb4 54569-5233 HUMAN PRESCRIPTI
EPC]" CIII
54569-5240_91abd550-33ca-422e-a1cd-9314e06d02bd 54569-5240 HUMAN PRESCRIPTI
CIII
54569-5255_f90a7fbe-800b-4f62-ba0d-565e46db4f48 54569-5255 HUMAN PRESCRIPTI
ON DRUG Midazolam Hydrochloride MIDAZOLAM HYDROCHLORIDE "INJECTION, SOLU
93 A-S Medication Solutions LLC MIDAZOLAM HYDROCHLORIDE 1 mg/mL
54569-5273_081d3a77-a34f-4dc8-b032-6e25ec6cacd1 54569-5273 HUMAN PRESCRIPTI
ON DRUG NEXIUM Esomeprazole magnesium "CAPSULE, DELAYED RELEASE"
LLC ESOMEPRAZOLE MAGNESIUM 20 mg/1
54569-5274_081d3a77-a34f-4dc8-b032-6e25ec6cacd1 54569-5274 HUMAN PRESCRIPTI
LLC ESOMEPRAZOLE MAGNESIUM 40 mg/1
54569-5305_ac3e86e8-8e45-46f3-a843-a462f7b92755 54569-5305 HUMAN PRESCRIPTI
ON DRUG Norco Hydrocodone Bitatrate and Acetaminophen TABLET ORAL
ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/1; mg/1 "Opioid
54569-5339_5cd78d23-972b-4315-81f4-cd92eb5ba018 54569-5339 HUMAN PRESCRIPTI
NDA NDA021015 A-S Medication Solutions LLC TESTOSTERONE 10
mg/g "Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/I
ngredient]" CIII
54569-5353_78db3b0c-fec8-4c51-86f5-5ac38501f455 54569-5353 HUMAN PRESCRIPTI
gredient]"
54569-5354_23c27189-0dc2-4b9e-a23a-4fd20448cdd2 54569-5354 HUMAN PRESCRIPTI
gredient]"
gredient]"
54569-5386_5990533c-1cf1-40d9-9196-cebc33fea8b7 54569-5386 HUMAN PRESCRIPTI
olutions LLC CEFUROXIME AXETIL 250 mg/1 "Cephalosporin Antibacte
54569-5401_307d6c8f-791e-441f-9684-76a5fbfb793a 54569-5401 HUMAN PRESCRIPTI
54569-5418_61e9cd92-819c-42aa-99b5-85629dc58542 54569-5418 HUMAN PRESCRIPTI
ON DRUG Cefuroxime axetil Cefuroxime axetil "TABLET, FILM CO
olutions LLC CEFUROXIME AXETIL 500 mg/1 "Cephalosporin Antibacte
54569-5470_615b7651-9fc6-4715-ac65-4941d8475769 54569-5470 HUMAN PRESCRIPTI
ANDA091569 A-S Medication Solutions LLC AMOXICILLIN; CLAVULANATE POTASSI
hibitors [MoA]"
54569-5471_615b7651-9fc6-4715-ac65-4941d8475769 54569-5471 HUMAN PRESCRIPTI
hibitors [MoA]"
54569-5487_d6b3f1a0-c188-4f59-9186-9765150373bb 54569-5487 HUMAN PRESCRIPTI
ANDA ANDA201090 A-S Medication Solutions LLC AMOXICILLIN; CLAVULANATE
hibitors [MoA]"
54569-5488_d6b3f1a0-c188-4f59-9186-9765150373bb 54569-5488 HUMAN PRESCRIPTI
54569-5489_a1796b03-b6a5-4a25-950b-cede4d002197 54569-5489 HUMAN PRESCRIPTI
ON DRUG Zetia Ezetimibe TABLET ORAL 20090727
NDA NDA021445 A-S Medication Solutions LLC EZETIMIBE 10
mg/1 "Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption In
hibitor [EPC]"
ANDA ANDA077856 A-S Medication Solutions LLC CLONAZEPAM 2
54569-5517_d046cdd4-05b7-4fb9-937b-d8c4eb2c3a4d 54569-5517 HUMAN PRESCRIPTI
oA]" CIII
54569-5523_16f07404-8729-4ec9-85b1-f0cf26182df1 54569-5523 HUMAN PRESCRIPTI
CIII
54569-5532_5cb1d2e0-d759-4ba9-bb99-b4267adc071b 54569-5532 HUMAN PRESCRIPTI
ON DRUG REYATAZ ATAZANAVIR SULFATE "CAPSULE, GELATIN COATED"
LLC ATAZANAVIR SULFATE 200 mg/1 "HIV Protease Inhibitors [MoA],P
rotease Inhibitor [EPC]"
54569-5553_5b222f1a-5a60-460e-a3dd-924ef07c3585 54569-5553 HUMAN PRESCRIPTI
54569-5574_40858305-7dd8-44f1-b564-8e54a6f49649 54569-5574 HUMAN PRESCRIPTI
54569-5584_40858305-7dd8-44f1-b564-8e54a6f49649 54569-5584 HUMAN PRESCRIPTI
54569-5595_ffdcd70b-6de2-4b87-a1ad-f685297975bb 54569-5595 HUMAN PRESCRIPTI
ON DRUG Testim testosterone GEL TRANSDERMAL 20021031
NDA NDA021454 A-S Medication Solutions LLC TESTOSTERONE 50
mg/5g "Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/I
ngredient]" CIII
54569-5600_77a9257b-0826-4283-84d9-f88ad9125474 54569-5600 HUMAN PRESCRIPTI
ROSUVASTATIN CALCIUM 10 mg/1
54569-5616_bef63518-6728-40f1-95d6-0f4586887a34 54569-5616 HUMAN PRESCRIPTI
ON DRUG medroxyprogesterone acetate medroxyprogesterone acetate
"INJECTION, SUSPENSION" INTRAMUSCULAR 19921029 NDA AUTHORIZED G
ENERIC NDA020246 A-S Medication Solutions LLC MEDROXYPROGESTERONE ACET
ATE 150 mg/mL "Progesterone Congeners [Chemical/Ingredient],Progestin
[EPC]"
54569-5638_184b7d98-815c-4aa7-83a3-d5f28104c734 54569-5638 HUMAN PRESCRIPTI
ate Potassium "TABLET, CHEWABLE" ORAL 20050210 ANDA
UM 400; 57 mg/1; mg/1 "Penicillin-class Antibacterial [EPC],Penicillin
[MoA]"
54569-5684_f3327069-f904-418f-9a42-7ee8dc10209d 54569-5684 HUMAN PRESCRIPTI
ON DRUG Lunesta ESZOPICLONE "TABLET, COATED" ORAL 20050404
NDA NDA021476 A-S Medication Solutions LLC ESZOPICLONE 3
mg/1 CIV
54569-5689_a38095b7-9210-4f38-b5e5-6e4eeed7c7e3 54569-5689 HUMAN PRESCRIPTI
ON DRUG amoxicillin and clavulanate potassium amoxicillin and clavulan
NDA NDA050575 A-S Medication Solutions LLC AMOXICILLIN; CLAVULANATE
hibitors [MoA]"
54569-5690_7b89e1ee-11a9-4754-a392-847e7d2ddfeb 54569-5690 HUMAN PRESCRIPTI
ANDA ANDA065191 A-S Medication Solutions LLC AMOXICILLIN; CLAVULANIC
ACID 400; 57 mg/5mL; mg/5mL "Penicillin-class Antibacterial [EPC],Penicillin
[MoA]"
54569-5696_f3327069-f904-418f-9a42-7ee8dc10209d 54569-5696 HUMAN PRESCRIPTI
ON DRUG Lunesta ESZOPICLONE "TABLET, COATED" ORAL 20050404
NDA NDA021476 A-S Medication Solutions LLC ESZOPICLONE 2
mg/1 CIV
54569-5727_3fa443fd-017a-43ee-b9b0-96deed23e825 54569-5727 HUMAN PRESCRIPTI
54569-5729_df5d6099-eee3-4eeb-9176-e76e3eb87425 54569-5729 HUMAN PRESCRIPTI
54569-5736_9df20a4a-bf75-4fba-9118-b06f679e23f6 54569-5736 HUMAN PRESCRIPTI
ON DRUG Promethazine VC Promethazinehydrochloride and phenylephrine hydr
ochloride SYRUP ORAL 20061207 ANDA ANDA040654
A-S Medication Solutions LLC PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROC
HLORIDE 5; 6.25 mg/5mL; mg/5mL "Phenothiazine [EPC],Phenothiazines [Chemical/In
gredient],alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA]"
54569-5750_41243d21-6839-4821-8ed0-ec7e5d88e944 54569-5750 HUMAN PRESCRIPTI
ON DRUG TRICOR fenofibrate TABLET ORAL 20051107
NDA NDA021656 A-S Medication Solutions LLC FENOFIBRATE 145
54569-5758_bc1bf9e6-053c-43b3-aa6b-19f89f417d5d 54569-5758 HUMAN PRESCRIPTI
ANDA077002 A-S Medication Solutions LLC DIGOXIN 250 ug/1 "Cardiac
54569-5759_76066d10-dded-41cd-a395-dcfb68975896 54569-5759 HUMAN PRESCRIPTI
]"
54569-5760_855d8ecb-78d9-48c5-82f9-7f6e995b3484 54569-5760 HUMAN PRESCRIPTI
ON DRUG Ambien CR zolpidem tartrate "TABLET, COATED" ORAL
ZOLPIDEM TARTRATE 12.5 mg/1 "gamma-Aminobutyric Acid-ergic Agonist [
54569-5785_2c67d656-e294-45a5-b906-0886e1bd8f87 54569-5785 HUMAN PRESCRIPTI
ON DRUG CEFPROZIL CEFPROZIL "POWDER, FOR SUSPENSION"
LLC CEFPROZIL 250 mg/5mL
54569-5800_e9513240-af57-4890-bff1-55e713bb7d20 54569-5800 HUMAN PRESCRIPTI
ANDA ANDA040182 A-S Medication Solutions LLC ACETAMINOPHEN; HYDROCODO
NE BITARTRATE 167; 2.5 mg/5mL; mg/5mL "Opioid Agonist [EPC],Opioid Ago
nists [MoA]" CIII
54569-5813_01714fb6-6ac6-4f07-8985-ce1f91306ea5 54569-5813 HUMAN PRESCRIPTI
A-S Medication Solutions LLC SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160
54569-5825_9d69020f-ad21-42fa-89de-2b4e37ff9506 54569-5825 HUMAN PRESCRIPTI
NDA NDA021724 A-S Medication Solutions LLC PREGABALIN 75
mg/1 CV
54569-5831_5164db94-101c-47a0-b55a-5886c0457d96 54569-5831 HUMAN PRESCRIPTI
54569-5840_34487f13-b1d5-4c72-a92d-68c3e8370bef 54569-5840 HUMAN PRESCRIPTI
mg/1
54569-5864_5cb1d2e0-d759-4ba9-bb99-b4267adc071b 54569-5864 HUMAN PRESCRIPTI
ON DRUG REYATAZ ATAZANAVIR SULFATE "CAPSULE, GELATIN COATED"
LLC ATAZANAVIR SULFATE 300 mg/1 "HIV Protease Inhibitors [MoA],P
rotease Inhibitor [EPC]"
54569-5875_e197a271-44fd-438c-b887-3b2101480353 54569-5875 HUMAN PRESCRIPTI
ON DRUG Oxandrolone oxandrolone TABLET ORAL 20070820
ANDA ANDA077827 A-S Medication Solutions LLC OXANDROLONE 10
mg/1 CIII
54569-5877_4191aab5-8555-4cf2-b203-8e304e6a0909 54569-5877 HUMAN PRESCRIPTI
ON DRUG BICILLIN L-A PENICILLIN G BENZATHINE "INJECTION, SUSPENSION"
INTRAMUSCULAR 19520627 NDA NDA050141 A-S Medication S
olutions LLC PENICILLIN G BENZATHINE 1200000 [iU]/2mL "Penicillin-clas
54569-5906_00441b0a-66be-4fee-ac3d-9bd40cd36138 54569-5906 HUMAN PRESCRIPTI
olutions LLC ZOLPIDEM TARTRATE 5 mg/1 "gamma-Aminobutyric Acid
-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Centr
al Nervous System Depression [PE]" CIV
54569-5907_00441b0a-66be-4fee-ac3d-9bd40cd36138 54569-5907 HUMAN PRESCRIPTI
olutions LLC ZOLPIDEM TARTRATE 10 mg/1 "gamma-Aminobutyric Acid
54569-5912_8dc9a65d-76c2-49fd-8973-b1313cc32c2f 54569-5912 HUMAN PRESCRIPTI
ON DRUG BENZPHETAMINE HYDROCHLORIDE benzphetamine hydrochloride
olutions LLC BENZPHETAMINE HYDROCHLORIDE 50 mg/1 "Appetite Suppre
EPC]" CIII
54569-5917_818fc618-a75a-4367-b42b-f82e7f80cb72 54569-5917 HUMAN PRESCRIPTI
ORAL 20100806 20141231 ANDA ANDA065429 A-S Medication S
olutions LLC CEFDINIR MONOHYDRATE 250 mg/5mL "Cephalosporin Antibacte
54569-5918_77544fc3-0347-491a-856e-9516828f4bf8 54569-5918 HUMAN PRESCRIPTI
LLC CEFDINIR 250 mg/5mL "Cephalosporin Antibacterial [EPC],Cepha
54569-5921_ad90fa84-dfe8-4a47-8a0c-f9bdaf896e3e 54569-5921 HUMAN PRESCRIPTI
ON DRUG Cefdinir Cefdinir CAPSULE ORAL 20070501
ANDA ANDA065264 A-S Medication Solutions LLC CEFDINIR 300
54569-5945_d12b39e6-1f28-45de-a18b-318fe75d7dc2 54569-5945 HUMAN PRESCRIPTI
oA]" CIII
54569-5962_109416fe-1d51-4901-95e0-452898d9c40b 54569-5962 HUMAN PRESCRIPTI
CIII
54569-5964_d12b39e6-1f28-45de-a18b-318fe75d7dc2 54569-5964 HUMAN PRESCRIPTI
CIII
54569-5966_a7b6d648-02b0-4906-b3c8-f9542f355dda 54569-5966 HUMAN PRESCRIPTI
54569-5988_cdb716c6-a2ef-4b34-905d-e172648e71b5 54569-5988 HUMAN PRESCRIPTI
ON DRUG Butorphanol Tartrate Butorphanol Tartrate "SPRAY, METERED"
NASAL 20020312 ANDA ANDA075824 A-S Medication Solutions
LLC BUTORPHANOL TARTRATE 10 mg/mL "Competitive Opioid Antagonists
[MoA],Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA]" CIV
54569-6027_91abd550-33ca-422e-a1cd-9314e06d02bd 54569-6027 HUMAN PRESCRIPTI
oA]" CIII
54569-6037_c56bb269-31bc-49a8-a017-e25f2ba490b1 54569-6037 HUMAN PRESCRIPTI
54569-6043_fc4e913d-99eb-453c-a2e7-c361b1f6d331 54569-6043 HUMAN PRESCRIPTI
54569-6044_8bcaa4a6-bd8d-4f3f-91af-91dc7cc9f2a9 54569-6044 HUMAN PRESCRIPTI
ON DRUG Diazepam DIAZEPAM "INJECTION, SOLUTION" INTRAMUS
CULAR; INTRAVENOUS 19871013 ANDA ANDA071583 A-S Medi
cation Solutions LLC DIAZEPAM 5 mg/mL "Benzodiazepine [EPC],Be
54569-6100_ca07f858-ccfa-4d33-a9a7-19fea82799d8 54569-6100 HUMAN PRESCRIPTI
EPC]" CIV
54569-6118_5325d61f-1cf2-4bb7-a77f-b49a80621de8 54569-6118 HUMAN PRESCRIPTI
ON DRUG Zaleplon Zaleplon CAPSULE ORAL 20080606
ANDA ANDA077239 A-S Medication Solutions LLC ZALEPLON 10
54569-6121_6a573ce6-e6d6-48cb-9b81-85282390488c 54569-6121 HUMAN PRESCRIPTI
ON DRUG Hydrocodone Bitartrate and Ibuprofen hydrocodone bitartrate a
nd ibuprofen "TABLET, FILM COATED" ORAL 20061106 ANDA
ANDA077723 A-S Medication Solutions LLC HYDROCODONE BITARTRATE; IBUPROFE
N 7.5; 200 mg/1; mg/1 "Opioid Agonist [EPC],Opioid Agonists [M
oA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Ch
emical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]" CIII
54569-6164_1213d76e-f9d6-4d61-9660-9b7715d66367 54569-6164 HUMAN OTC DRUG
Cheratussin AC codeine phosphate and guaifenesin LIQUID ORAL
LLC CODEINE PHOSPHATE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL CV
54569-6187_50f7047c-4afe-45fe-9f73-856109e8a704 54569-6187 HUMAN PRESCRIPTI
ON DRUG Alprazolam alprazolam "TABLET, EXTENDED RELEASE"
LLC ALPRAZOLAM 1 mg/1 "Benzodiazepine [EPC],Benzodiazepines [C
54569-6195_01ae6a69-8130-490c-b9b5-4701f6da998f 54569-6195 HUMAN PRESCRIPTI
20070723 20140930 ANDA ANDA065267 A-S Medication Solutions
LLC CEFPROZIL 500 mg/1
54569-6231_aaceea69-9ee0-48cc-9d96-9c51764baa0e 54569-6231 HUMAN PRESCRIPTI
A-S Medication Solutions LLC ZOLPIDEM TARTRATE 12.5 mg/1 "gamma-A
mg/1 CV
mg/1 CV
54569-6244_8bd52f8e-b1ac-4a9c-847e-20cf837693e3 54569-6244 HUMAN PRESCRIPTI
ON DRUG Nuvigil armodafinil TABLET ORAL 20090601
NDA NDA021875 A-S Medication Solutions LLC ARMODAFINIL 150
mg/1 CIV
54569-6295_bd492b38-51ea-4a13-9beb-51c50260c253 54569-6295 HUMAN PRESCRIPTI
A-S Medication Solutions LLC HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5
54569-6325_e77e80f1-60e9-4034-a2bc-d19592c754a2 54569-6325 HUMAN PRESCRIPTI
ON DRUG Butrans buprenorphine "PATCH, EXTENDED RELEASE" TRANSDER
MAL 20110214 NDA NDA021306 A-S Medication Solutions
LLC BUPRENORPHINE 10 ug/h "Partial Opioid Agonist [EPC],Partial Op
54569-6326_e77e80f1-60e9-4034-a2bc-d19592c754a2 54569-6326 HUMAN PRESCRIPTI
ON DRUG Butrans buprenorphine "PATCH, EXTENDED RELEASE" TRANSDER
MAL 20110214 NDA NDA021306 A-S Medication Solutions
LLC BUPRENORPHINE 20 ug/h "Partial Opioid Agonist [EPC],Partial Op
mg/1 CV
54569-6337_754251f5-fa40-4df6-ab8e-58dfa507d946 54569-6337 HUMAN PRESCRIPTI
NDA NDA022309 A-S Medication Solutions LLC TESTOSTERONE 16.2
mg/g "Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/I
ngredient]" CIII
54569-6362_9b547f38-33b2-42ee-a09a-faa86a923074 54569-6362 HUMAN PRESCRIPTI
ON DRUG Hydrocodone Bitartate and Acetaminophen "HYDROCODONE BITARTRATE,
ACETAMINOPHEN" TABLET ORAL 20120517 ANDA ANDA040846
A-S Medication Solutions LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 2.5
54569-6376_8126b3c9-c9d6-4310-93b0-1cce931efb02 54569-6376 HUMAN PRESCRIPTI
ON DRUG Triazolam Triazolam TABLET ORAL 19940601
ANDA ANDA074224 A-S Medication Solutions LLC TRIAZOLAM 0.25
54569-6378_aaceea69-9ee0-48cc-9d96-9c51764baa0e 54569-6378 HUMAN PRESCRIPTI
A-S Medication Solutions LLC ZOLPIDEM TARTRATE 6.25 mg/1 "gamma-A
54569-6399_6cda900a-356d-48cc-917f-fef5d458d54f 54569-6399 HUMAN PRESCRIPTI
ON DRUG Suboxone "buprenorphine hydrochloride, naloxone hydrochlo
ride" "FILM, SOLUBLE" SUBLINGUAL 20100913 NDA NDA02241
0 A-S Medication Solutions LLC BUPRENORPHINE HYDROCHLORIDE; NALOXONE HY
DROCHLORIDE 8; 2 mg/1; mg/1 "Partial Opioid Agonist [EPC],Partial Op
54569-6401_ada15ddb-c5d6-40fc-a06e-c142d5c7dc64 54569-6401 HUMAN PRESCRIPTI
54569-6408_de5deb0d-2914-4adb-a6dc-b22efe996480 54569-6408 HUMAN PRESCRIPTI
A-S Medication Solutions LLC BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLOR
IDE DIHYDRATE 8; 2 mg/1; mg/1 "Partial Opioid Agonist [EPC],Partial Op
54569-6438_8b166910-60bf-48cf-b49c-d6950fb286df 54569-6438 HUMAN PRESCRIPTI
CIII
54569-6497_a39f1688-87ff-47b0-ba61-0a2c5f526118 54569-6497 HUMAN OTC DRUG
Guaifenesin and Codeine Phosphate Guaifenesin and Codeine Phosphat
e SOLUTION ORAL 20061001 OTC MONOGRAPH FINAL
part341 A-S Medication Solutions LLC CODEINE PHOSPHATE; GUAIFENESIN 10; 100
mg/5mL; mg/5mL CV
54569-6500_eb73b8e2-63be-4e0e-8a34-14d397228176 54569-6500 HUMAN PRESCRIPTI
ANDA ANDA040838 A-S Medication Solutions LLC ACETAMINOPHEN; HYDROCODO
NE BITARTRATE 325; 7.5 mg/15mL; mg/15mL "Opioid Agonist [EPC],Op
54569-6543_17ff5457-dee6-43a2-8533-40b290e0441c 54569-6543 HUMAN PRESCRIPTI
ON DRUG Eszopiclone Eszopiclone "TABLET, FILM COATED" ORAL
ESZOPICLONE 2 mg/1 CIV
54569-6544_f7f78a29-0297-46fc-aadd-46fbeed2a8c5 54569-6544 HUMAN PRESCRIPTI
ESZOPICLONE 3 mg/1
54569-8310_155716d0-67bd-49f0-a42f-e02dbd57809e 54569-8310 HUMAN PRESCRIPTI
54569-8311_74248ed7-221f-4c79-ab82-6e41d968e051 54569-8311 HUMAN PRESCRIPTI
54569-8314_8fdff5df-1119-431e-a05f-2782e644f3a2 54569-8314 HUMAN PRESCRIPTI
CIII
54569-8318_74248ed7-221f-4c79-ab82-6e41d968e051 54569-8318 HUMAN PRESCRIPTI
54569-8704_2cd1a781-db31-409e-8af2-f555646d2b52 54569-8704 HUMAN PRESCRIPTI
mg/1 CV
mg/1 CV
mg/1 CV
mg/1 CV
67877-105_75cdeaee-7a49-4386-b4e1-baca5e98afac 67877-105 HUMAN PRESCRIPTI
ANDA ANDA040627 Ascend Laboratories LLC BENZONATATE 100 mg/1
"Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antituss
ive [EPC]"
67877-106_75cdeaee-7a49-4386-b4e1-baca5e98afac 67877-106 HUMAN PRESCRIPTI
ANDA ANDA040749 Ascend Laboratories LLC BENZONATATE 200 mg/1
ive [EPC]"
67877-116_aa8e14c1-fbfd-4e4d-b59e-2d4ae1ca815f 67877-116 HUMAN PRESCRIPTI
ON DRUG Methadone Hydrochloride Methadone Hydrochloride TABLET ORAL
20120116 ANDA ANDA090635 "Ascend Laboratories, LLC"
METHADONE HYDROCHLORIDE 10 mg/1 "Full Opioid Agonists [MoA],Opioid Agoni
st [EPC]" CII
67877-119_95a71bca-6bdd-4a52-bab5-96bce3c03c21 67877-119 HUMAN PRESCRIPTI
ON DRUG ibuprofen ibuprofen TABLET ORAL 20090206
ANDA ANDA078329 "Ascend Laboratories, LLC" IBUPROFEN 400
67877-124_4d53c3ed-098a-4540-8866-29f02084ef73 67877-124 HUMAN PRESCRIPTI
ON DRUG Silver Sulfadiazine Silver Sulfadiazine CREAM TOPICAL
19851223 NDA NDA018810 "Ascend Laboratories, LLC"
SILVER SULFADIAZINE 10 mg/g "Sulfonamide Antibacterial [EPC],Sulfona
mides [Chemical/Ingredient]"
67877-146_92b119d2-8554-4610-a37d-93d9e8e300f0 67877-146 HUMAN PRESCRIPTI
ANDA ANDA071456 "Ascend Laboratories, LLC" TEMAZEPAM 15
ANDA ANDA071457 "Ascend Laboratories, LLC" TEMAZEPAM 30
ANDA ANDA071457 "Ascend Laboratories, LLC" TEMAZEPAM 7.5
ANDA ANDA071457 "Ascend Laboratories, LLC" TEMAZEPAM 22.5
67877-159_93cce808-2234-4bb5-a03d-15d037800bb7 67877-159 HUMAN PRESCRIPTI
ON DRUG Metformin hydrochloride Metformin hydrochloride "TABLET, EXTENDE
D RELEASE" ORAL 20130301 ANDA ANDA201991 "Ascend
Laboratories, LLC" METFORMIN HYDROCHLORIDE 500 mg/1 "Biguanide [EPC]
67877-164_2ff6983b-28c6-4730-8ba6-62c1113115be 67877-164 HUMAN PRESCRIPTI
ANDA ANDA200694 "Ascend Laboratories, LLC" LAMOTRIGINE 25
67877-169_2edc0788-dc38-4d21-ba8e-71f159e2d3b1 67877-169 HUMAN PRESCRIPTI
TABLET ORAL 20070106 ANDA ANDA077851 "Ascend Laborato
ries, LLC" ONDANSETRON HYDROCHLORIDE 4 mg/1 "Serotonin 3 Rec
67877-170_2edc0788-dc38-4d21-ba8e-71f159e2d3b1 67877-170 HUMAN PRESCRIPTI
ries, LLC" ONDANSETRON HYDROCHLORIDE 8 mg/1 "Serotonin 3 Rec
67877-171_0952644e-ef42-4dcb-b07f-6901cda78ec0 67877-171 HUMAN PRESCRIPTI
ANDA ANDA079220 "Ascend Laboratories, LLC" ANASTROZOLE 1
67877-171_4dcb2dbc-c4c1-43a4-950d-b24062e4d174 67877-171 HUMAN PRESCRIPTI
ANDA ANDA079220 "Ascend Laboratories, LLC" ANASTROZOLE 1
67877-184_de33da5e-1833-4875-915c-578380409b54 67877-184 HUMAN PRESCRIPTI
ries, LLC" GRANISETRON HYDROCHLORIDE 1 mg/1 "Serotonin 3 Rec
67877-197_53dfef4a-a4b4-4509-b075-a01ad04b9a6d 67877-197 HUMAN PRESCRIPTI
ON DRUG Amlodipine Besylate Amlodipine besylate TABLET ORAL
67877-210_2f44db39-e1d9-451e-ba31-e4b10366a430 67877-210 HUMAN PRESCRIPTI
ON DRUG ZALEPLON ZALEPLON CAPSULE ORAL 20101215
ANDA ANDA078989 "Ascend Laboratories, LLC" ZALEPLON 5
67877-211_2f44db39-e1d9-451e-ba31-e4b10366a430 67877-211 HUMAN PRESCRIPTI
ANDA ANDA078989 "Ascend Laboratories, LLC" ZALEPLON 10
67877-215_c479a484-940d-413b-9275-1fcd7fca060a 67877-215 HUMAN PRESCRIPTI
ATED" ORAL 20101201 ANDA ANDA065496 "Ascend Laborato
ries, LLC" CEFUROXIME AXETIL 250 mg/1 "Cephalosporin Antibacte
67877-216_c479a484-940d-413b-9275-1fcd7fca060a 67877-216 HUMAN PRESCRIPTI
ries, LLC" CEFUROXIME AXETIL 500 mg/1 "Cephalosporin Antibacte
67877-217_5036898b-af0f-40e5-a3b8-b1a8ba947de5 67877-217 HUMAN PRESCRIPTI
ries, LLC" METFORMIN HYDROCHLORIDE 500 mg/1 "Biguanide [EPC],Biguani
67877-219_c000482e-30ee-4143-a39d-92fbc153df26 67877-219 HUMAN PRESCRIPTI
ANDA ANDA090836 "Ascend Laboratories, LLC" CEPHALEXIN 500
67877-222_2f3d901a-6f50-4893-abc6-5b325af3e740 67877-222 HUMAN PRESCRIPTI
ANDA ANDA090858 "Ascend Laboratories, LLC" GABAPENTIN 100
67877-225_519c5699-0704-4d4e-b69b-d6575631d558 67877-225 HUMAN PRESCRIPTI
ON DRUG Mycophenolate Mofetil Mycophenolate Mofetil "TABLET, FILM CO
ries, LLC" MYCOPHENOLATE MOFETIL 500 mg/1 Antimetabolite Immunosup
pressant [EPC]
67877-229_4803da82-c0c2-4c1b-bb89-3bc39585058d 67877-229 HUMAN PRESCRIPTI
ON DRUG Timolol Maleate Timolol Maleate SOLUTION OPHTHALMIC
TIMOLOL MALEATE 5 mg/mL "Adrenergic beta-Antagonists [MoA],beta-Adrenerg
ic Blocker [EPC]"
67877-240_6b8eebc0-0c5c-40b2-b449-e10d7658f2f2 67877-240 HUMAN PRESCRIPTI
emical/Ingredient]"
67877-241_6b8eebc0-0c5c-40b2-b449-e10d7658f2f2 67877-241 HUMAN PRESCRIPTI
emical/Ingredient]"
67877-242_f2e10990-cec1-4d81-9f70-311ee8114f9e 67877-242 HUMAN PRESCRIPTI
67877-251_235cc145-0232-4504-b4f2-fa6dd5f02a2c 67877-251 HUMAN PRESCRIPTI
ON DRUG Triamcinolone Acetonide Triamcinolone Acetonide CREAM TOPICAL
67877-266_519c5699-0704-4d4e-b69b-d6575631d558 67877-266 HUMAN PRESCRIPTI
ON DRUG mycophenolate mofetil mycophenolate mofetil CAPSULE ORAL
67877-268_2c1bb382-e246-4976-aaa1-6aac9394eaaf 67877-268 HUMAN PRESCRIPTI
ON DRUG "Sulfacetamide Sodium, Sulfur" "Sulfacetamide Sodium, Sulfur"
LOTION TOPICAL 20111108 UNAPPROVED DRUG OTHER "Ascend
Laboratories, LLC" SULFACETAMIDE SODIUM; SULFUR 100; 50 mg/g; mg/g
67877-269_ff2f0d9b-5aea-4a43-968c-8acd9eb02f64 67877-269 HUMAN PRESCRIPTI
ON DRUG Pramoxine-HC Hydrocortisone / Chloroxylenol / Pramoxine HCl
SOLUTION/ DROPS AURICULAR (OTIC) 20110926 UNAPPROVED DRUG
OTHER "Ascend Laboratories, LLC" CHLOROXYLENOL; HYDROCORTISONE; P
RAMOXINE HYDROCHLORIDE 1; 10; 10 mg/mL; mg/mL; mg/mL "Corticosteroid
67877-272_324d6901-cca8-4177-9cb9-fa7169d6cd3e 67877-272 HUMAN PRESCRIPTI
ON DRUG Urea Urea CREAM TOPICAL 20120116 UNAPPROV
ED DRUG OTHER "Ascend Laboratories, LLC" UREA 400 mg/g
67877-273_324d6901-cca8-4177-9cb9-fa7169d6cd3e 67877-273 HUMAN PRESCRIPTI
ON DRUG Urea Urea LOTION TOPICAL 20120116 UNAPPROV
ED DRUG OTHER "Ascend Laboratories, LLC" UREA 400 mg/mL
67877-290_e9bd55cd-318f-4dae-8555-67b954205545 67877-290 HUMAN PRESCRIPTI
ries, LLC" HYDRALAZINE HYDROCHLORIDE 100 mg/1 "Arteriolar Vaso
67877-294_20b162c8-6e92-4008-a075-fd362c42301c 67877-294 HUMAN PRESCRIPTI
67877-305_17d56b39-9fd8-4253-b33a-d54f2cc82ef5 67877-305 HUMAN PRESCRIPTI
ON DRUG Urea Urea CREAM TOPICAL 20130601 UNAPPROV
ED DRUG OTHER "Ascend Laboratories, LLC" UREA 390 mg/g
67877-312_1895dc98-ff36-4d29-9e00-b577de53a837 67877-312 HUMAN PRESCRIPTI
ON DRUG Hydrocortisone Acetate Hydrocortisone Acetate SUPPOSITORY
RECTAL 20131001 UNAPPROVED DRUG OTHER "Ascend Laborato
ries, LLC" HYDROCORTISONE ACETATE 25 mg/1 "Corticosteroid [EPC],Co
17139-613_c5f5a1df-d4c3-40ee-95a4-37544a95d899 17139-613 HUMAN PRESCRIPTI
ON DRUG EstroGel estradiol "GEL, METERED" TRANSDERMAL
20040209 NDA NDA021166 "ASCEND Therapeutics US, LLC"
ESTRADIOL 0.75 mg/1.25g "Estradiol Congeners [Chemical/Ingredien
t],Estrogen [EPC],Estrogen Receptor Agonists [MoA]"
17139-617_dba16853-27fb-41c3-b4f3-390dea5820b2 17139-617 HUMAN PRESCRIPTI
ON DRUG EstroGel estradiol "GEL, METERED" TRANSDERMAL
20040209 NDA NDA021166 "ASCEND Therapeutics US, LLC"
ESTRADIOL 0.75 mg/1.25g "Estradiol Congeners [Chemical/Ingredien
t],Estrogen [EPC],Estrogen Receptor Agonists [MoA]"
76420-491_891e1993-503a-4700-9f78-799b96caf154 76420-491 VACCINE Medical
Provider Single Use EZ Flu Shot Fluvirin 2014-2015 "influenza a vir
us a/christchurch/16/2010 nib-74 (h1n1) antigen (propiolactone inactivated), inf
luenza a virus a/victoria/361/2011 ivr-165 (h3n2) antigen (propiolactone inactiv
ated), influenza b virus b/hubei-wujiagang/158/2009 bx-39 antigen (propiolactone
inactivated) and Isopropyl Alcohol" KIT INTRAMUSCULAR; TOPICAL 20130915
BLA BLA103837 "Asclemed USA, Inc."
76420-493_3bfb0420-80c7-4eb2-8bb2-69556e0de417 76420-493 VACCINE Medical
Provider Single Use EZ Flu Shot Flucelvax 2014-2015 Kit "influenza a vir
us a/brisbane/10/2010 (h1n1) antigen (mdck cell derived, propiolactone inactivat
ed), influenza a virus a/texas/50/2012 x-223a (h3n2) antigen (mdck cell derived,
propiolactone inactivated), and influenza b virus b/massachusetts/2/2012 antige
n (mdck cell derived, propiolactone inactivated) and Isopropyl Alcohol" KIT
INTRAMUSCULAR; TOPICAL 20130701 20150630 BLA BLA125408
"Asclemed USA, Inc."
76420-635_4bde2874-4253-4687-97f1-a7f207dfbd6c 76420-635 HUMAN PRESCRIPTI
ON DRUG Advanced DNA Medicated Collection Kit II "LIDOCAINE HYDRO
CHLORIDE, GLYCERIN" KIT ORAL; TOPICAL 20140204 ANDA
ANDA040014 "Asclemed USA, Inc."
76420-720_528221e7-1df3-4b08-b722-96550e850cff 76420-720 HUMAN PRESCRIPTI
ON DRUG Bupivilog Kit "marcaine, kenalog, povidone iodine" KIT
EPIDURAL; INTRA-ARTICULAR; INTRAMUSCULAR; TOPICAL 20140204
NDA NDA016964 "Asclemed USA, Inc."
76420-730_c0b35fb5-37d7-4938-ae8c-c6ee2040b5e0 76420-730 HUMAN PRESCRIPTI
ON DRUG Marlido Kit "marcaine, lidocaine, povidone iodine" KIT
EPIDURAL; INFILTRATION; TOPICAL 20140204 NDA NDA016964
76420-735_679c11d0-21e9-47ad-80fd-4574ee412627 76420-735 HUMAN PRESCRIPTI
ON DRUG Marlido 25 Kit "Lidocaine Hydrochloride, Bupivacaine Hydrochlor
ide, Povidine Iodine" KIT EPIDURAL; INFILTRATION; TOPICAL; TOPICAL
20090908 NDA NDA016964 "Asclemed USA, Inc."
76420-740_c4807eeb-5438-473b-85c4-af2b74562900 76420-740 HUMAN PRESCRIPTI
ON DRUG MLK F1 Kit "marcaine, lidocaine, kenalog, povidone iodine"
KIT EPIDURAL; INFILTRATION; INTRA-ARTICULAR; INTRAMUSCULAR 20140116
76420-742_cec890d9-5927-4e91-9dfa-9b6c11a37295 76420-742 HUMAN PRESCRIPTI
ON DRUG MLK Kit F2 "marcaine, lidocaine, kenalog, povidone iodine"
KIT EPIDURAL; INFILTRATION; INTRA-ARTICULAR; INTRAMUSCULAR; TOPICAL 20140204
76420-743_254029f8-3fb6-4669-be8b-d1c01c4e97b4 76420-743 HUMAN PRESCRIPTI
ON DRUG MLK F3 Kit "marcaine, lidocaine, kenalog, povidone iodine"
KIT EPIDURAL; INFILTRATION; INTRA-ARTICULAR; INTRAMUSCULAR; TOPICAL 20140204
76420-744_d6788e34-d8c9-46ae-8294-f6aeeebb3809 76420-744 HUMAN PRESCRIPTI
ON DRUG MLK F4 Kit "Triamcinolone Acetonide, Lidocaine Hydrochlorid
e, Bupivacaine Hydrochloride, Povidine Iodine" KIT EPIDURAL; INFILTRATION;
INFILTRATION; INTRA-ARTICULAR; INTRAMUSCULAR; TOPICAL 20090601
76420-750_9b5da9eb-b6f6-41bd-a6fe-392cc229d16a 76420-750 HUMAN PRESCRIPTI
ON DRUG Dyural 40 Kit "Methylprednisolone Acetate, Lidocaine Hydrochlo
ride, Bupivacaine Hydrochloride, Povidine Iodine, Sodium Chloride, Isopropyl Alc
ohol" KIT EPIDURAL; INFILTRATION; INTRA-ARTICULAR; INTRALESIONAL; INTRAMUS
CULAR; INTRAVENOUS; SOFT TISSUE; SUBCUTANEOUS; TOPICAL 20140725
76420-755_28789e3f-6f36-4d6f-adb4-d86262cfbbe4 76420-755 HUMAN PRESCRIPTI
ON DRUG Dyural 80 Kit "Methylprednisolone Acetate, Lidocaine Hydrochlo
ride, Bupivacaine Hydrochloride, Povidine Iodine, Sodium Chloride, Isopropyl Alc
ohol" KIT EPIDURAL; INFILTRATION; INTRA-ARTICULAR; INTRALESIONAL; INTRAMUS
CULAR; INTRAVENOUS; SOFT TISSUE; SUBCUTANEOUS; TOPICAL 19590528
76420-760_3f109a04-5dce-4288-9889-d6d83d4e7e95 76420-760 HUMAN PRESCRIPTI
ON DRUG Lidolog Kit "lidocaine, kenalog, povidone iodine" KIT
EPIDURAL; INFILTRATION; INTRA-ARTICULAR; INTRAMUSCULAR; TOPICAL 20140204
76420-765_fe903c24-cf80-4333-a2d4-a33eb2742df9 76420-765 HUMAN PRESCRIPTI
ON DRUG Betalido Kit "Betamethasone Sodium Phosphate, Betamethasone A
cetate, Lidocaine, Povidine Iodine" KIT INFILTRATION; INTRA-ARTICULAR; I
NTRALESIONAL; INTRAMUSCULAR; PERINEURAL; TOPICAL 20140613
ANDA ANDA090747 "Asclemed USA, Inc."
76420-766_b9197908-b841-49c3-a6f1-2775209c97a3 76420-766 HUMAN PRESCRIPTI
ON DRUG DoubleDex Kit "Dexamethasone Sodium Phosphate, Povidine Iodine
" KIT INTRAMUSCULAR; INTRAVENOUS; TOPICAL 20140725
76420-767_307e409f-0dfd-4978-901f-a127bea7d5a8 76420-767 HUMAN PRESCRIPTI
ON DRUG Dexlido Kit "Dexamethasone Sodium Phosphate, Lidocaine Hydro
chloride, Povidine Iodine" KIT INFILTRATION; INTRAMUSCULAR; INTRAVENOUS
; TOPICAL 20140725 ANDA ANDA040491 "Asclemed USA, I
nc."
76420-769_3811f322-3852-4fdc-988a-53e7f7c0c7b4 76420-769 HUMAN PRESCRIPTI
ON DRUG Dexlido-M Kit "Dexamethasone Sodium Phosphate, Lidocaine Hydro
chloride, Maricaine, Povidine Iodine" KIT EPIDURAL; INFILTRATION; INTRAMUS
CULAR; INTRAVENOUS; TOPICAL 20140725 ANDA ANDA040491
76420-770_83633b57-d4a7-454a-84d7-999824fb8a99 76420-770 HUMAN PRESCRIPTI
ON DRUG Interarticular Joint Kit "AMMONIA, LIDOCAINE HYDROCHLORID
E ANHYDROUS, TRIAMCINOLONE ACETONIDE, POVIDONE-IODINE" KIT INFILTRATION; IN
TRA-ARTICULAR; INTRAMUSCULAR; RESPIRATORY (INHALATION); TOPICAL 20140205
76420-771_1ac9d3b2-a246-4117-93dc-e7ccc6a7ac0e 76420-771 HUMAN PRESCRIPTI
ON DRUG Ketorocaine L Kit "Ketorolac Tromethamine, Lidocaine Hydro
chloride, Povidine Iodine" KIT INFILTRATION; INTRAMUSCULAR; INTRAVENOUS
; TOPICAL 19970605 ANDA ANDA074802 "Asclemed USA, I
nc."
76420-772_f4a07aaa-a7f6-49e1-b100-40725ffbd365 76420-772 HUMAN PRESCRIPTI
ON DRUG Ketorocaine LM Kit "Ketorolac Tromethamine, Lidocaine Hydro
chloride, Bupivacaine Hydrochloride, Povidine Iodine" KIT EPIDURAL; INFILT
RATION; INTRAMUSCULAR; INTRAVENOUS; TOPICAL 19970605 ANDA
ANDA074802 "Asclemed USA, Inc."
76420-775_31989839-a391-4f5b-8430-cae0c50d176c 76420-775 HUMAN PRESCRIPTI
ON DRUG Dyural L Kit "Methylprednisolone Acetate, Lidocaine Hydrochlo
ride, Povidine Iodine, Isopropyl Alcohol" KIT INFILTRATION; INTRA-ARTI
CULAR; INTRALESIONAL; INTRAMUSCULAR; SOFT TISSUE; TOPICAL 19590528
76420-780_53f3c96c-6360-4082-85f4-204066545562 76420-780 HUMAN PRESCRIPTI
ON DRUG Multi-Specialty Kit "Depo-Medrol, Lidocaine, Isopropyl Alcoh
ol" KIT INFILTRATION; INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; SOF
T TISSUE; TOPICAL 20140206 NDA NDA011757 "Ascleme
d USA, Inc."
76420-782_2466e8b9-7011-4028-9ba3-8cc972290aa2 76420-782 HUMAN PRESCRIPTI
ON DRUG Marbeta L Kit "Betamethasone Sodium Phosphate, Betamethasone A
cetate, Lidocaine Hydrochloride, Bupivacaine Hydrochloride, Povidine Iodine, Iso
propyl Alcohol" KIT EPIDURAL; INFILTRATION; INTRA-ARTICULAR; INTRALESIONAL;
INTRAMUSCULAR; TOPICAL 20100428 ANDA ANDA090747 "Ascleme
d USA, Inc."
76420-785_83119181-366d-4619-ba60-1b8a7b1e3a2e 76420-785 HUMAN PRESCRIPTI
ON DRUG Marbeta 25 Kit "Betamethasone Sodium Phosphate and Betamethason
e Acetate, Bupivacaine Hydrochloride, Povidine Iodine" KIT EPIDURAL; INFILT
RATION; INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; TOPICAL 20100428
76420-795_d376a354-fe32-4ae7-90ee-6444baf7a623 76420-795 HUMAN PRESCRIPTI
ON DRUG Dyural LM Kit "Methylprednisolone Acetate, Lidocaine Hydrochlo
ride, Bupivacaine Hydrochloride, Povidine Iodine, Isopropyl Alcohol" KIT
EPIDURAL; INFILTRATION; INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; SOFT TISS
UE; TOPICAL 19590528 NDA NDA011757 "Asclemed USA, I
nc."
76420-810_4da9e3c6-2788-4986-a7bc-75144247487e 76420-810 HUMAN PRESCRIPTI
ON DRUG Mardex 25 Kit "Dexamethasone Sodium Phosphate, Bupivacaine Hyd
rochloride, Povidine Iodine" KIT EPIDURAL; INFILTRATION; INTRAMUSCULAR; I
NTRAVENOUS; TOPICAL 20030529 ANDA ANDA040491 "Ascleme
d USA, Inc."
51997-035_4298c46d-2fc3-44f2-b096-fbce32d993fa 51997-035 HUMAN OTC DRUG
"Emergency Eye Wash, PW, Sterile" Ster-Aide Water FOR SOLUTION
OPHTHALMIC 20120910 OTC MONOGRAPH NOT FINAL part349 "Asept P
ak, Inc." WATER 14.85 mL/15mL
51511-514_0ce3d56c-6195-4eee-bb7c-d3a9392c96b6 51511-514 HUMAN OTC DRUG
Salicylic Acid Corn Remover Salicylic Acid STRIP TOPICAL 20100201
OTC MONOGRAPH FINAL part358B ASO Pharmaceutical Co. Ltd. SALICYLI
C ACID 40 mg/1
51511-596_4edae879-d026-4c2d-b14b-9a82c12a6352 51511-596 HUMAN OTC DRUG
Salicylic Acid Wart Remover Salicylic Acid STRIP TOPICAL 20090201
OTC MONOGRAPH FINAL part358H ASO Pharmaceutical Co. Ltd. SALICYLI
C ACID 40 mg/1
42914-001_66767af9-a49d-4441-b7ad-a2632aa5604c 42914-001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS Aspen Air US Corp OXYGEN 99 L/100L
42914-010_73ec05a3-2685-4def-83ab-9602c73ede21 42914-010 HUMAN PRESCRIPTI
20071215 UNAPPROVED MEDICAL GAS Aspen Air US Corp
NITROGEN 99 L/100L
76388-635_37120d60-9477-4629-a746-e70bee7ddf97 76388-635 HUMAN PRESCRIPTI
ON DRUG LEUKERAN chlorambucil "TABLET, FILM COATED" ORAL
19850213 NDA NDA010669 Aspen Global Inc. CHLORAMB
UCIL 2 mg/1 "Alkylating Activity [MoA],Alkylating Drug [EPC]"
76388-713_5fcf4541-4b08-407d-b67f-6ac95f759f90 76388-713 HUMAN PRESCRIPTI
ON DRUG MYLERAN busulfan "TABLET, FILM COATED" ORAL 19850321
NDA NDA009386 Aspen Global Inc. BUSULFAN 2 mg/1
76388-880_f20f28e5-1a12-499b-adbc-8c949d7e1aa1 76388-880 HUMAN PRESCRIPTI
ON DRUG TABLOID thioguanine TABLET ORAL 20130312
NDA NDA012429 Aspen Global Inc. THIOGUANINE 40 mg/1
Antimetabolite [EPC]
65802-001_34be7da2-4ef0-4c3e-9b81-fbbe2f9bbbf6 65802-001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS Aspirus Keweenaw Home Medical Equipment OXYGEN
99 L/100L
33992-0128_7a6d1cc4-509b-4941-b1e7-6017a4f516bf 33992-0128 HUMAN OTC DRUG
All Day Allergy Relief Cetirizine HCl TABLET ORAL 20121019
ANDA ANDA078427 "ASSURED (Greenbrier International, Inc.)" CETIRIZI
33992-0029_12342f19-468e-45a1-8072-d8311ba1edc6 33992-0029 HUMAN OTC DRUG
Magnesium Citrate Magnesium citrate LIQUID ORAL 20140731
OTC MONOGRAPH NOT FINAL part334 "ASSURED / DOLLAR TREE (Greenbrier International
, Inc.)" MAGNESIUM CITRATE 1.745 g/29.6mL
33992-0107_5e5f943a-dcfd-4faa-aa4f-2906e94d5d6c 33992-0107 HUMAN OTC DRUG
Mucus Relief Expectorant Guaifenesin TABLET ORAL 20130416
OTC MONOGRAPH FINAL part341 "ASSURED / DOLLAR TREE (Greenbrier International
, Inc.)" GUAIFENESIN 400 mg/1
33992-0109_35b0a079-c535-4e26-b043-9646facf3789 33992-0109 HUMAN OTC DRUG
Mucus Relief DM Expectorant and Cough Suppressant Dextromethorphan Hydrobr
omide and Guaifenesin "TABLET, COATED" ORAL 20100106
, Inc.)" DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg
/1
33992-0129_99132b29-974e-40ae-85c5-5ae577c10378 33992-0129 HUMAN OTC DRUG
All Day Allergy Relief Cetirizine HCl TABLET ORAL 20100706
ANDA ANDA078780 "ASSURED / DOLLAR TREE (Greenbrier International, Inc.)"
CETIRIZINE HYDROCHLORIDE 10 mg/1
33992-0183_8c8f0c4b-fdd0-49c6-a603-fc960af1df7f 33992-0183 HUMAN OTC DRUG
Menstrual Relief Maximum Strength "Acetaminophen, Caffeine, Pyrila
mine maleate" TABLET ORAL 20140131 OTC MONOGRAPH NOT FINAL
part343 "ASSURED / DOLLAR TREE (Greenbrier International, Inc.)" ACETAMIN
OPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1
33992-0213_ef4f5bfb-5425-469f-ae97-0e38edef48a1 33992-0213 HUMAN OTC DRUG
Pain Relief PM Extra strength "Acetaminophen, Diphenhydramine HCl" "TABLET,
"ASSURED / DOLLAR TREE (Greenbrier International, Inc.)" ACETAMINOPHEN; D
IPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1
33992-0268_eea39001-f67b-40a4-896c-07510e41b35d 33992-0268 HUMAN OTC DRUG
Hydrogen Peroxide 3 Percent Hydrogen Peroxide LIQUID TOPICAL
20140829 OTC MONOGRAPH NOT FINAL part356 "ASSURED / DOLLAR TREE (
Greenbrier International, Inc.)" HYDROGEN PEROXIDE 2.65 mL/100mL
33992-0271_aba26b5d-aff6-40cc-8093-6c1fcbbad964 33992-0271 HUMAN OTC DRUG
Isopropyl alcohol 50 percent Isopropyl alcohol LIQUID TOPICAL
20140731 OTC MONOGRAPH NOT FINAL part333A "ASSURED / DOLLA
R TREE (Greenbrier International, Inc.)" ISOPROPYL ALCOHOL 50
mL/100mL
33992-0520_d5327cb0-8d60-46ca-86d2-ae1d1695f93e 33992-0520 HUMAN OTC DRUG
Anti-Diarrheal Loperamide HCl "CAPSULE, LIQUID FILLED" ORAL
20131120 NDA NDA021855 "ASSURED / DOLLAR TREE (Greenbri
er International, Inc.)" LOPERAMIDE HYDROCHLORIDE 2 mg/1
33992-1100_e6eebf85-48bf-453d-9f8d-0f13074d0807 33992-1100 HUMAN OTC DRUG
Daytime Sinus Relief Acetaminophen and Phenylephrine Hydrochloride
"CAPSULE, LIQUID FILLED" ORAL 20131209 OTC MONOGRAPH FI
NAL part341 "ASSURED / DOLLAR TREE (Greenbrier International, Inc.)"
ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1
33992-2270_daeaa324-6546-4330-a9d3-b0b93da2d853 33992-2270 HUMAN OTC DRUG
Aspirin Low Dose Safety Coated Aspirin TABLET ORAL 20130331
, Inc.)" ASPIRIN 81 mg/1
33992-2300_2fe02208-dc55-4086-ac3f-fff1196d2144 33992-2300 HUMAN OTC DRUG
Sleep-Aid Maximum Strength Diphenhydramine HCl CAPSULE ORAL
20100706 OTC MONOGRAPH FINAL part341 "ASSURED / DOLLAR TREE (
Greenbrier International, Inc.)" DIPHENHYDRAMINE HYDROCHLORIDE 50
mg/1
33992-2360_9aa8bcd7-757b-4c17-adbe-fcedc4a5087c 33992-2360 HUMAN OTC DRUG
Sleep Aid Maximum Strength Diphenhydramine HCl CAPSULE ORAL
20140201 OTC MONOGRAPH FINAL part341 "ASSURED / DOLLAR TREE (
Greenbrier International, Inc.)" DIPHENHYDRAMINE HYDROCHLORIDE 50
mg/1
51248-150_9d4c0f37-4aa2-4b61-a643-444519206779 51248-150 HUMAN PRESCRIPTI
ON DRUG VESIcare solifenacin succinate "TABLET, FILM COATED"
ORAL 20050105 NDA NDA021518 "Astellas Pharma Technol
ogies, Inc." SOLIFENACIN SUCCINATE 5 mg/1 "Cholinergic Muscarinic
51248-151_9d4c0f37-4aa2-4b61-a643-444519206779 51248-151 HUMAN PRESCRIPTI
ON DRUG VESIcare solifenacin succinate "TABLET, FILM COATED"
ORAL 20050105 NDA NDA021518 "Astellas Pharma Technol
ogies, Inc." SOLIFENACIN SUCCINATE 10 mg/1 "Cholinergic Muscarinic
0469-3525_7f97eb3c-50f3-4767-8581-9d6f4cac3e91 0469-3525 HUMAN PRESCRIPTI
ON DRUG Vibativ telavancin hydrochloride "INJECTION, POWDER, LYOP
HILIZED, FOR SOLUTION" INTRAVENOUS 20091105 NDA NDA02211
0 Astellas Pharma US Inc. TELAVANCIN HYDROCHLORIDE 250 mg/1
0469-3575_7f97eb3c-50f3-4767-8581-9d6f4cac3e91 0469-3575 HUMAN PRESCRIPTI
ON DRUG Vibativ telavancin hydrochloride "INJECTION, POWDER, LYOP
0 Astellas Pharma US Inc. TELAVANCIN HYDROCHLORIDE 750 mg/1
0469-5201_17cc7208-9df0-4f45-921c-54b8c16882d7 0469-5201 HUMAN PRESCRIPTI
ON DRUG Protopic Tacrolimus OINTMENT TOPICAL 20001208
NDA NDA050777 Astellas Pharma US Inc. TACROLIMUS 0.3 mg/g
0469-5202_17cc7208-9df0-4f45-921c-54b8c16882d7 0469-5202 HUMAN PRESCRIPTI
ON DRUG Protopic Tacrolimus OINTMENT TOPICAL 20001208
NDA NDA050777 Astellas Pharma US Inc. TACROLIMUS 1 mg/g
0469-0125_641e0fc2-d4ab-4b42-a9b3-a10ad6624ad6 0469-0125 HUMAN PRESCRIPTI
ON DRUG Xtandi enzalutamide CAPSULE ORAL 20120831
NDA NDA203415 "Astellas Pharma US, Inc." ENZALUTAMIDE 40
mg/1 "Androgen Receptor Inhibitor [EPC],Androgen Receptor Antagonists [MoA],C
ytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome
P450 2C19 Inducers [MoA]"
0469-0607_b19e1237-84b0-4f2d-9f91-5b5d785a8d25 0469-0607 HUMAN PRESCRIPTI
19980824 NDA NDA050708 "Astellas Pharma US, Inc."
TACROLIMUS 0.5 mg/1 "Calcineurin Inhibitor Immunosuppressant [EPC],C
alcineurin Inhibitors [MoA]"
TACROLIMUS 1 mg/1 "Calcineurin Inhibitor Immunosuppressant [EPC],C
0469-0647_eb7f57f3-f54a-4198-8c5c-1171de882d94 0469-0647 HUMAN PRESCRIPTI
ON DRUG ASTAGRAF XL tacrolimus extended-release capsules "CAPSULE
, COATED, EXTENDED RELEASE" ORAL 20130719 NDA NDA20409
6 "Astellas Pharma US, Inc." TACROLIMUS 0.5 mg/1 "Calcine
urin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA]"
TACROLIMUS 5 mg/1 "Calcineurin Inhibitor Immunosuppressant [EPC],C
6 "Astellas Pharma US, Inc." TACROLIMUS 1 mg/1 "Calcine
6 "Astellas Pharma US, Inc." TACROLIMUS 5 mg/1 "Calcine
0469-0871_90a3d9fa-fe07-4e31-8cfa-b5e95217dd88 0469-0871 HUMAN PRESCRIPTI
ON DRUG Adenoscan adenosine SOLUTION INTRAVENOUS
ADENOSINE 3 mg/mL "Adenosine Receptor Agonist [EPC],Adenosine Rece
ptor Agonists [MoA]"
0469-2601_dcf7c82b-2af6-474c-9c6b-a0ccdd3bbe7f 0469-2601 HUMAN PRESCRIPTI
ON DRUG Myrbetriq mirabegron "TABLET, FILM COATED, EXTENDED R
ELEASE" ORAL 20120628 NDA NDA202611 "Astellas Pharma
US, Inc." MIRABEGRON 25 mg/1 "beta3-Adrenergic Agonist [EPC],
Adrenergic beta3-Agonists [MoA],Cytochrome P450 2D6 Inhibitors [MoA]"
0469-2602_dcf7c82b-2af6-474c-9c6b-a0ccdd3bbe7f 0469-2602 HUMAN PRESCRIPTI
ON DRUG Myrbetriq mirabegron "TABLET, FILM COATED, EXTENDED R
ELEASE" ORAL 20120628 NDA NDA202611 "Astellas Pharma
US, Inc." MIRABEGRON 50 mg/1 "beta3-Adrenergic Agonist [EPC],
Adrenergic beta3-Agonists [MoA],Cytochrome P450 2D6 Inhibitors [MoA]"
ON DRUG Prograf Tacrolimus "INJECTION, SOLUTION" INTRAVENOUS
TACROLIMUS 5 mg/mL "Calcineurin Inhibitor Immunosuppressant [EPC],C
0469-3051_3ab7fe3b-149e-4ff5-826a-1e23a6d39b55 0469-3051 HUMAN PRESCRIPTI
ON DRUG AmBisome amphotericin B "INJECTION, POWDER, LYOPHILIZED,
FOR SOLUTION" INTRAVENOUS 19970811 NDA NDA050740
"Astellas Pharma US, Inc." AMPHOTERICIN B 50 mg/12.5mL "Lipid-b
ased Polyene Antifungal [EPC],Polyene Antifungal [EPC],Polyenes [Chemical/Ingred
ient]"
0469-3211_be62349e-a4fe-4eec-bb2b-36e168d56a2d 0469-3211 HUMAN PRESCRIPTI
ON DRUG MYCAMINE micafungin sodium "INJECTION, POWDER, LYOP
6 "Astellas Pharma US, Inc." MICAFUNGIN SODIUM 20 mg/mL
"Echinocandin Antifungal [EPC],Lipopeptides [Chemical/Ingredient]"
0469-3250_be62349e-a4fe-4eec-bb2b-36e168d56a2d 0469-3250 HUMAN PRESCRIPTI
ON DRUG MYCAMINE micafungin sodium "INJECTION, POWDER, LYOP
6 "Astellas Pharma US, Inc." MICAFUNGIN SODIUM 10 mg/mL
"Echinocandin Antifungal [EPC],Lipopeptides [Chemical/Ingredient]"
0469-6501_241e642c-a97b-45e1-a5c0-ade43b3bfb7c 0469-6501 HUMAN PRESCRIPTI
ON DRUG Lexiscan regadenoson "INJECTION, SOLUTION" INTRAVEN
OUS 20080410 NDA NDA022161 "Astellas Pharma US, Inc
." REGADENOSON 0.08 mg/mL "Adenosine Receptor Agonist [EPC],Adenos
ine Receptor Agonists [MoA]"
0469-8234_c617444d-edaf-4b37-8ea1-de8d411c9f44 0469-8234 HUMAN PRESCRIPTI
ON DRUG Adenocard adenosine SOLUTION INTRAVENOUS
ADENOSINE 3 mg/mL "Adenosine Receptor Agonist [EPC],Adenosine Rece
ptor Agonists [MoA]"
0186-0004_6abc915a-163a-4e85-a6e6-ce7231b3f4ad 0186-0004 HUMAN PRESCRIPTI
ON DRUG ATACAND Candesartan cilexetil TABLET ORAL 19980914
NDA NDA020838 AstraZeneca LP CANDESARTAN CILEXETIL 4 mg/1
0186-0162_4d3c2520-111f-4263-9bfc-218e7c2d3cc5 0186-0162 HUMAN PRESCRIPTI
ON DRUG ATACAND HCT Candesartan cilexetil and Hydrochlorothiazide
TABLET ORAL 20000928 NDA NDA021093 AstraZeneca LP
CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE 16; 12.5 mg/1; mg/1
ON DRUG ATACAND HCT Candesartan cilexetil and Hydrochlorothiazide
CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE 32; 12.5 mg/1; mg/1
ON DRUG ATACAND HCT Candesartan cilexetil Hydrochlorothiazide
CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE 32; 25 mg/1; mg/1 "Angiote
nsin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased
0186-0370_27d7a2ed-c38a-42af-a9f9-57fe258d2d9e 0186-0370 HUMAN PRESCRIPTI
ON DRUG SYMBICORT Budesonide and Formoterol Fumarate Dihydrate
AEROSOL RESPIRATORY (INHALATION) 20070529 NDA NDA02192
9 AstraZeneca LP BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE 160; 4.5
ug/1; ug/1 "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [
MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]"
0186-0372_27d7a2ed-c38a-42af-a9f9-57fe258d2d9e 0186-0372 HUMAN PRESCRIPTI
ON DRUG SYMBICORT Budesonide and Formoterol Fumarate Dihydrate
AEROSOL RESPIRATORY (INHALATION) 20070529 NDA NDA02192
9 AstraZeneca LP BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE 80; 4.5
ug/1; ug/1 "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [
MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]"
0186-0450_61f6ed30-f9dc-4caa-a120-54969ed3091e 0186-0450 HUMAN PRESCRIPTI
ON DRUG PLENDIL Felodipine "TABLET, EXTENDED RELEASE" ORAL
19941004 NDA NDA019834 AstraZeneca LP FELODIPINE
2.5 mg/1 "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Chann
el Blocker [EPC],Dihydropyridines [Chemical/Ingredient]"
5 mg/1 "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Chann
0186-0510_94e8108f-5c9d-4252-8c0a-95d196e6f784 0186-0510 HUMAN PRESCRIPTI
ON DRUG VIMOVO naproxen and esomeprazole magnesium "TABLET, DELAYED
RELEASE" ORAL 20100706 NDA NDA022511 AstraZen
eca LP ESOMEPRAZOLE MAGNESIUM; NAPROXEN 20; 375 mg/1; mg/1 "Cycloox
edient],Nonsteroidal Anti-inflammatory Drug [EPC],Proton Pump Inhibitor [EPC],Pr
oton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]"
0186-0520_94e8108f-5c9d-4252-8c0a-95d196e6f784 0186-0520 HUMAN PRESCRIPTI
ON DRUG VIMOVO naproxen and esomeprazole magnesium "TABLET, DELAYED
RELEASE" ORAL 20100706 NDA NDA022511 AstraZen
eca LP ESOMEPRAZOLE MAGNESIUM; NAPROXEN 20; 500 mg/1; mg/1 "Cycloox
edient],Nonsteroidal Anti-inflammatory Drug [EPC],Proton Pump Inhibitor [EPC],Pr
oton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]"
0186-0606_00b7d931-923e-4fdb-9736-e75e96ad3859 0186-0606 HUMAN PRESCRIPTI
ON DRUG PRILOSEC Omeprazole magnesium "CAPSULE, DELAYED RELEAS
E" ORAL 19951115 NDA NDA019810 AstraZeneca LP
OMEPRAZOLE MAGNESIUM 10 mg/1 "Proton Pump Inhibitor [EPC],Proton Pump
ON DRUG PRILOSEC Omeprazole magnesium "GRANULE, DELAYED RELEAS
ON DRUG PRILOSEC Omeprazole magnesium "GRANULE, DELAYED RELEAS
OMEPRAZOLE MAGNESIUM 2.5 mg/1 "Proton Pump Inhibitor [EPC],Proton Pump
0186-0702_e164e160-3021-4d1c-97c6-71b1b082525f 0186-0702 HUMAN PRESCRIPTI
ON DRUG ENTOCORT EC Budesonide CAPSULE ORAL 20011029
NDA NDA021234 AstraZeneca LP BUDESONIDE 3 mg/1 "Cortico
0186-0777_2903d56b-ba8e-4428-bba3-e33a3d9630b2 0186-0777 HUMAN PRESCRIPTI
ON DRUG BRILINTA Ticagrelor TABLET ORAL 20110805
NDA NDA022433 AstraZeneca LP TICAGRELOR 90 mg/1 "P2Y12 P
latelet Inhibitor [EPC],Phenylalanine Hydroxylase Activators [MoA],Decreased Pla
telet Aggregation [PE],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 3A4 Inhi
bitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA
]"
0186-0916_bcc98d74-44e4-4526-9edf-3ca577b2add2 0186-0916 HUMAN PRESCRIPTI
ON DRUG PULMICORT FLEXHALER Budesonide "AEROSOL, POWDER"
RESPIRATORY (INHALATION) 20070319 NDA NDA021949
AstraZeneca LP BUDESONIDE 180 ug/1 "Corticosteroid [EPC],Corticoste
0186-0917_bcc98d74-44e4-4526-9edf-3ca577b2add2 0186-0917 HUMAN PRESCRIPTI
ON DRUG PULMICORT FLEXHALER Budesonide "AEROSOL, POWDER"
RESPIRATORY (INHALATION) 20070319 NDA NDA021949
AstraZeneca LP BUDESONIDE 90 ug/1 "Corticosteroid [EPC],Corticoste
0186-1070_db4ce2c5-a1a2-4f37-bb4a-e99d01bce1fb 0186-1070 HUMAN PRESCRIPTI
ON DRUG RHINOCORT AQUA Budesonide "SPRAY, METERED" NASAL
20010402 NDA NDA020746 AstraZeneca LP BUDESONIDE
32 ug/1 "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [
MoA]"
0186-1073_8b2657a9-5510-439f-affd-131b23bb28c4 0186-1073 HUMAN PRESCRIPTI
ON DRUG Budesonide Budesonide "SPRAY, METERED" NASAL
20140513 NDA NDA020746 AstraZeneca LP BUDESONIDE
32 ug/1 "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [
MoA]"
0186-1087_044641f6-8d64-4fb4-3b94-639dba979043 0186-1087 HUMAN PRESCRIPTI
ON DRUG Dutoprol metoprolol succinate and hydrochlorothiazide
AstraZeneca LP HYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE 12.5; 25
mg/1; mg/1 "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
,Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient]
"
0186-1088_ff5e8364-a115-475f-a0ad-2e7c300b1990 0186-1088 HUMAN PRESCRIPTI
ON DRUG TOPROL XL Metoprolol succinate "TABLET, EXTENDED RELEASE"
ORAL 20010326 NDA NDA019962 AstraZeneca LP METOPROL
OL SUCCINATE 25 mg/1 "Adrenergic beta-Antagonists [MoA],beta-Adrenerg
ic Blocker [EPC]"
ic Blocker [EPC]"
ic Blocker [EPC]"
ic Blocker [EPC]"
"
"
0186-1988_37814a0a-646e-44b1-bb71-323bab776259 0186-1988 HUMAN PRESCRIPTI
ON DRUG PULMICORT RESPULES Budesonide SUSPENSION RESPIRAT
ORY (INHALATION) 20000908 NDA NDA020929 AstraZen
eca LP BUDESONIDE 0.25 mg/2mL "Corticosteroid [EPC],Corticosteroid Hor
eca LP BUDESONIDE 0.5 mg/2mL "Corticosteroid [EPC],Corticosteroid Hor
eca LP BUDESONIDE 1 mg/2mL "Corticosteroid [EPC],Corticosteroid Hor
0186-4010_2419e97d-8ed0-4a3f-8f6a-411d46018716 0186-4010 HUMAN PRESCRIPTI
ON DRUG NEXIUM Esomeprazole magnesium "GRANULE, DELAYED RELEASE"
ORAL 20080707 NDA NDA022101 AstraZeneca LP ESOMEPRA
ZOLE MAGNESIUM 10 mg/1 "Proton Pump Inhibitor [EPC],Proton Pump Inhibit
ors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]"
ZOLE MAGNESIUM 2.5 mg/1 "Proton Pump Inhibitor [EPC],Proton Pump Inhibit
0186-6020_64c661b3-bb99-45fe-bb40-9aa2ced68f07 0186-6020 HUMAN PRESCRIPTI
ON DRUG NEXIUM I.V. Esomeprazole sodium INJECTION INTRAVENOUS
20050503 NDA NDA021689 AstraZeneca LP ESOMEPRAZOLE SOD
IUM 20 mg/5mL "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA
0186-6040_64c661b3-bb99-45fe-bb40-9aa2ced68f07 0186-6040 HUMAN PRESCRIPTI
ON DRUG NEXIUM I.V. Esomeprazole sodium INJECTION INTRAVENOUS
20050503 NDA NDA021689 AstraZeneca LP ESOMEPRAZOLE SOD
IUM 40 mg/5mL "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA
0310-0101_4ba4dffe-0ec0-462b-96a3-fdab78685968 0310-0101 HUMAN PRESCRIPTI
ON DRUG TENORMIN Atenolol TABLET ORAL 19900901
NDA NDA018240 AstraZeneca Pharmaceuticals LP ATENOLOL 100
0310-0115_fe61473a-7ca4-44d7-9de1-1e83d820581a 0310-0115 HUMAN PRESCRIPTI
ON DRUG TENORETIC Atenolol and Chlorthalidone TABLET ORAL
19900901 NDA NDA018760 AstraZeneca Pharmaceuticals LP
ATENOLOL; CHLORTHALIDONE 50; 25 mg/1; mg/1 "Adrenergic beta-Antagon
ists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide-like D
iuretic [EPC]"
0310-0117_fe61473a-7ca4-44d7-9de1-1e83d820581a 0310-0117 HUMAN PRESCRIPTI
ON DRUG TENORETIC Atenolol and Chlorthalidone TABLET ORAL
ATENOLOL; CHLORTHALIDONE 100; 25 mg/1; mg/1 "Adrenergic beta-Antagon
ists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide-like D
iuretic [EPC]"
0310-0130_8ff30a43-8afa-45ec-a5f0-8e41246a08e7 0310-0130 HUMAN PRESCRIPTI
ON DRUG ZESTRIL Lisinopril TABLET ORAL 20091111
NDA NDA019777 AstraZeneca Pharmaceuticals LP LISINOPRIL 5
NDA NDA019777 AstraZeneca Pharmaceuticals LP LISINOPRIL 2.5
0310-0141_255bb026-ffbd-4194-a4fb-85a0ce76af8f 0310-0141 HUMAN PRESCRIPTI
ON DRUG ZESTORETIC Lisinopril and Hydrochlorothiazide TABLET
ORAL 20100615 NDA NDA019888 AstraZeneca Pharmaceutic
als LP HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 "Angiote
ient]"
als LP HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 "Angiote
ient]"
als LP HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 "Angiotensin Con
verting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],In
creased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient]"
0310-0201_449d8fd6-abe2-4bc8-8bc9-67874ef86966 0310-0201 HUMAN PRESCRIPTI
ON DRUG ARIMIDEX Anastrozole TABLET ORAL 19960116
NDA NDA020541 AstraZeneca Pharmaceuticals LP ANASTROZOLE 1
0310-0208_6dd1a001-9fbb-4247-59ab-aa31e5283a05 0310-0208 HUMAN PRESCRIPTI
ON DRUG ZOMIG Zolmitriptan "SPRAY, METERED" NASAL 20031020
NDA NDA021450 AstraZeneca Pharmaceuticals LP ZOLMITRIPTAN 5
mg/1 "Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [Mo
A],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]"
0310-0209_0caf812b-a1c7-4f82-d797-3d13071f7e80 0310-0209 HUMAN PRESCRIPTI
ON DRUG ZOMIG ZMT Zolmitriptan "TABLET, ORALLY DISINTEGRATING"
als LP ZOLMITRIPTAN 2.5 mg/1 "Serotonin 1b Receptor Agonists [MoA],Se
t [EPC]"
ON DRUG ZOMIG Zolmitriptan TABLET ORAL 19980110
NDA NDA020768 AstraZeneca Pharmaceuticals LP ZOLMITRIPTAN 2.5
ON DRUG ZOMIG Zolmitriptan TABLET ORAL 19980110
NDA NDA020768 AstraZeneca Pharmaceuticals LP ZOLMITRIPTAN 5
ON DRUG ZOMIG ZMT Zolmitriptan "TABLET, ORALLY DISINTEGRATING"
als LP ZOLMITRIPTAN 5 mg/1 "Serotonin 1b Receptor Agonists [MoA],Se
t [EPC]"
0310-0271_ac37e409-4b2b-4db7-86f6-3173c9410120 0310-0271 HUMAN PRESCRIPTI
ON DRUG SEROQUEL Quetiapine fumarate "TABLET, FILM COATED"
als LP QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC]
0310-0280_89481c58-8da5-4636-9f86-562768009d8f 0310-0280 HUMAN PRESCRIPTI
ON DRUG SEROQUEL XR Quetiapine fumarate "TABLET, EXTENDED RELEAS
E" ORAL 20090201 NDA NDA022047 AstraZeneca Phar
maceuticals LP QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [
EPC]
EPC]
EPC]
EPC]
EPC]
0310-0321_247bb5e2-dfb0-4a75-bca8-f4504c71937e 0310-0321 HUMAN PRESCRIPTI
ON DRUG MERREM IV Meropenem INJECTION INTRAVENOUS 19960923
NDA NDA050706 AstraZeneca Pharmaceuticals LP MEROPENEM 1
g/30mL "Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC]"
0310-0325_247bb5e2-dfb0-4a75-bca8-f4504c71937e 0310-0325 HUMAN PRESCRIPTI
ON DRUG MERREM IV Meropenem INJECTION INTRAVENOUS 19960923
NDA NDA050706 AstraZeneca Pharmaceuticals LP MEROPENEM 500
mg/20mL "Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC]"
0310-0401_2b0262a7-3717-4db6-8be7-f419812dda5f 0310-0401 HUMAN PRESCRIPTI
ON DRUG ACCOLATE Zafirlukast "TABLET, FILM COATED" ORAL
0310-0402_2b0262a7-3717-4db6-8be7-f419812dda5f 0310-0402 HUMAN PRESCRIPTI
ON DRUG ACCOLATE Zafirlukast "TABLET, FILM COATED" ORAL
0310-0411_305566bf-f62c-4998-0497-8766c30db1b2 0310-0411 HUMAN PRESCRIPTI
ON DRUG ZAFIRLUKAST Zafirlukast "TABLET, FILM COATED" ORAL
0310-0412_305566bf-f62c-4998-0497-8766c30db1b2 0310-0412 HUMAN PRESCRIPTI
ON DRUG ZAFIRLUKAST Zafirlukast "TABLET, FILM COATED" ORAL
0310-0482_05f93d0b-f393-478e-8f3f-e441c5ff687b 0310-0482 HUMAN PRESCRIPTI
ON DRUG IRESSA Gefitinib "TABLET, COATED" ORAL 20030513
NDA NDA021399 AstraZeneca Pharmaceuticals LP GEFITINIB 250
mg/1 "Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]"
0310-0705_0f8dbdfb-d6d1-4f1b-ba69-d95546597d60 0310-0705 HUMAN PRESCRIPTI
ON DRUG CASODEX Bicalutamide TABLET ORAL 19951016
NDA NDA020498 AstraZeneca Pharmaceuticals LP BICALUTAMIDE 50
mg/1 "Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC]"
0310-0720_95ee8ea3-40dc-472a-8d77-95e45aed7cd5 0310-0720 HUMAN PRESCRIPTI
ON DRUG FASLODEX Fulvestrant INJECTION INTRAMUSCULAR
FULVESTRANT 50 mg/mL "Estrogen Receptor Antagonist [EPC],Estrogen Rec
eptor Antagonists [MoA],Selective Estrogen Receptor Modulators [MoA]"
0310-0751_3a498c46-5ad2-416a-875e-18e48b586954 0310-0751 HUMAN PRESCRIPTI
ROSUVASTATIN CALCIUM 10 mg/1 "HMG-CoA Reductase Inhibitor [EPC],Hydro
0310-0950_a7ec7fd0-2408-46e3-b495-7f1eac4de349 0310-0950 HUMAN PRESCRIPTI
ON DRUG ZOLADEX Goserelin acetate IMPLANT SUBCUTANEOUS 20030505
NDA NDA019726 AstraZeneca Pharmaceuticals LP GOSERELIN ACETATE
3.6 mg/1 "Gonadotropin Releasing Hormone Receptor Agonist [EPC],Gonadotro
pin Releasing Hormone Receptor Agonists [MoA]"
0310-0951_241b3fff-5821-42ec-80c3-49ad77402dd1 0310-0951 HUMAN PRESCRIPTI
ON DRUG ZOLADEX Goserelin acetate IMPLANT SUBCUTANEOUS 20030505
NDA NDA020578 AstraZeneca Pharmaceuticals LP GOSERELIN ACETATE
10.8 mg/1 "Gonadotropin Releasing Hormone Receptor Agonist [EPC],Gonadotro
pin Releasing Hormone Receptor Agonists [MoA]"
0310-1087_ddea171e-59a4-41af-aebc-f7cb995127e6 0310-1087 HUMAN PRESCRIPTI
AstraZeneca Pharmaceuticals LP HYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE
12.5; 25 mg/1; mg/1 "Adrenergic beta-Antagonists [MoA],beta-Adrenerg
ic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chem
ical/Ingredient]"
ical/Ingredient]"
ical/Ingredient]"
0310-7810_d1592dcf-a1ba-4c8d-50bf-c88126a930da 0310-7810 HUMAN PRESCRIPTI
ON DRUG Vandetanib Vandetanib TABLET ORAL 20110421
NDA NDA022405 AstraZeneca Pharmaceuticals LP VANDETANIB 100
mg/1 "Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],P-Glycoprotein I
nhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]"
0310-7820_cc6237ad-2ff7-4a29-a028-a41652466708 0310-7820 HUMAN PRESCRIPTI
ON DRUG CAPRELSA Vandetanib TABLET ORAL 20110725
0310-7830_d1592dcf-a1ba-4c8d-50bf-c88126a930da 0310-7830 HUMAN PRESCRIPTI
ON DRUG Vandetanib Vandetanib TABLET ORAL 20110421
0310-7840_cc6237ad-2ff7-4a29-a028-a41652466708 0310-7840 HUMAN PRESCRIPTI
ON DRUG CAPRELSA Vandetanib TABLET ORAL 20110725
57329-010_b9cbc519-8615-43a5-939e-0e2763e2d5ee 57329-010 HUMAN OTC DRUG
THERAFREEZE MENTHOL GEL TOPICAL 20130808 OTC MONO
GRAPH FINAL part341 Astrum Pharma MENTHOL 60 mg/mL
62712-221_4f76a1ca-05da-4535-ab8f-4bfd76188147 62712-221 HUMAN OTC DRUG
Free Hand ALCOHOL GEL TOPICAL 20091001 OTC MONO
GRAPH NOT FINAL part333E Atco International ALCOHOL 0.7 mL/mL
62712-575_c8baa644-5165-4b19-a6bd-636d71b6bec6 62712-575 HUMAN OTC DRUG
Handi-San BENZETHONIUM CHLORIDE LIQUID TOPICAL 20060101
OTC MONOGRAPH NOT FINAL part333E Atco International BENZETHONIUM CHL
ORIDE 2 mg/mL
53185-001_c3475692-c3be-44e6-bda3-8e9c7afb88c5 53185-001 HUMAN OTC DRUG
Clear Choice Allergy Relief CHLORPHENIRAMINE MALEATE TABLET
ORAL 20120823 OTC MONOGRAPH FINAL part341 Athlete's Needs
Inc CHLORPHENIRAMINE MALEATE 4 mg/1
53185-002_aeb6fab7-22bf-45d8-9617-bd3089001891 53185-002 HUMAN OTC DRUG
Extra Strength Pain Reliever ACETAMINOPHEN TABLET ORAL 20120913
OTC MONOGRAPH NOT FINAL part343 Athlete's Needs Inc ACETAMINOPHEN 500
mg/1
53185-003_31ab6ec9-33a6-465c-a512-d5c45b353705 53185-003 HUMAN OTC DRUG
Clear Choice Ibuprofen IBUPROFEN TABLET ORAL 20121009
ANDA ANDA079129 Athlete's Needs Inc IBUPROFEN 200 mg/1
53185-004_b132a177-4796-42aa-8de7-263549baf33e 53185-004 HUMAN OTC DRUG
Modern Pain Medicine Naproxen Sodium TABLET ORAL 20130506
ANDA ANDA079096 Athlete's Needs Inc NAPROXEN SODIUM 220 mg/1
53185-005_bee17e96-0a25-44cb-9006-bfff1e02af05 53185-005 HUMAN OTC DRUG
Regular Strength Pain Reliever ACETAMINOPHEN TABLET ORAL 20130603
OTC MONOGRAPH NOT FINAL part343 Athlete's Needs Inc ACETAMINOPHEN 325
mg/1
42165-0001_df9822b4-05fb-4ae7-b9af-64f834d1933f 42165-0001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS Atlanta Medical Gas LLC OXYGEN 99 L/100L
42165-0002_df9822b4-05fb-4ae7-b9af-64f834d1933f 42165-0002 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS Atlanta Medical Gas LLC OXYGEN 99 L/100L
17856-0008_ce62f292-478c-46bc-9538-a3d7465263e4 17856-0008 HUMAN OTC DRUG
Mucinex Guaifenesin "TABLET, EXTENDED RELEASE" ORAL 20120703
NDA NDA021282 Atlantic Biologicals Corps GUAIFENESIN 600
mg/1
17856-0021_42719fda-d898-4749-b561-f85a5e54cd06 17856-0021 HUMAN PRESCRIPTI
ON DRUG Renagel Renagel TABLET ORAL 20080606 NDA
NDA021179 Atlantic Biologicals Corps SEVELAMER HYDROCHLORIDE 800
mg/1 "Phosphate Binder [EPC],Phosphate Chelating Activity [MoA]"
17856-0057_7a0fee6f-de5d-4bf9-8a32-9e61e79d084c 17856-0057 HUMAN PRESCRIPTI
ON DRUG Digoxin Digoxin SOLUTION ORAL 20040826
NDA NDA021648 Atlantic Biologicals Corps DIGOXIN 0.05 mg/mL
"Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient]"
17856-0067_82c40b58-dc51-435a-9447-e3041bc921b2 17856-0067 HUMAN PRESCRIPTI
ANDA ANDA040420 Atlantic Biologicals Corps PHENYTOIN 125
17856-0079_f3b17ea9-5357-4b18-83a2-319b04f78ca7 17856-0079 HUMAN PRESCRIPTI
ON DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codein
e Phosphate SOLUTION ORAL 19960426 ANDA ANDA0401
19 Atlantic Biologicals Corps ACETAMINOPHEN; CODEINE PHOSPHATE
CV
17856-0082_e0b2e824-c9ae-4949-a75e-c34c459be4b6 17856-0082 HUMAN PRESCRIPTI
ON DRUG Acyclovir Acyclovir SUSPENSION ORAL 20050607
ANDA ANDA077026 Atlantic Biologicals Corps ACYCLOVIR 200
mg/5mL "DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog
17856-0088_f41a71be-60fe-4c50-baa0-f8986c6ee99b 17856-0088 HUMAN PRESCRIPTI
ANDA ANDA077728 Atlantic Biologicals Corps CALCIUM ACETATE 667
17856-0108_a5f6f300-167e-d40a-1071-f035c247c651 17856-0108 HUMAN PRESCRIPTI
ON DRUG RAMIPRIL RAMIPRIL CAPSULE ORAL 20080618
ANDA ANDA077900 Atlantic Biologicals Corps RAMIPRIL 5
17856-0194_84224201-655f-418c-ab0e-e39eaa7b5831 17856-0194 HUMAN PRESCRIPTI
ANDA ANDA078432 Atlantic Biologicals Corps NAPROXEN SODIUM 550
17856-0205_8fe8cdc9-104d-4dc7-a2ad-49f6e5894843 17856-0205 HUMAN PRESCRIPTI
ON DRUG Midazolam Hydrochloride Midazolam Hydrochloride SYRUP ORAL
20020705 ANDA ANDA076058 Atlantic Biologicals Corps
MIDAZOLAM HYDROCHLORIDE 2 mg/mL "Benzodiazepine [EPC],Benzodiazepines [C
17856-0241_0ce8f429-8cd1-4e90-bd8d-7175e5ab5022 17856-0241 HUMAN PRESCRIPTI
ON DRUG levetiracetam levetiracetam SOLUTION ORAL 20120228
ANDA ANDA090601 Atlantic Biologicals Corps LEVETIRACETAM 100
17856-0380_09287282-1b8e-4c4d-a32f-193630499b8e 17856-0380 HUMAN PRESCRIPTI
ANDA ANDA091384 Atlantic Biologicals Corps RISPERIDONE 1
mg/mL Atypical Antipsychotic [EPC]
17856-0423_4420e7d0-bd62-4500-9d5f-b0e29ab20202 17856-0423 HUMAN PRESCRIPTI
ON DRUG Donnatal phenobarbital elixir ELIXIR ORAL 20091101
UNAPPROVED DRUG OTHER Atlantic Biologicals Corps ATROPINE SULFATE
; HYOSCYAMINE SULFATE; PHENOBARBITAL; SCOPOLAMINE HYDROBROMIDE .0194; .1037; 16
.2; .0065 mg/5mL; mg/5mL; mg/5mL; mg/5mL "Anticholinergic [EPC],Cholinerg
ic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Choline
rgic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]"
17856-0443_66f70512-0231-48f7-b4ee-296aa63bd397 17856-0443 HUMAN OTC DRUG
STOOL SOFTENER EXTRA STRENGTH DOCUSATE SODIUM "CAPSULE, LIQUID FILLED"
ORAL 20100709 OTC MONOGRAPH NOT FINAL part334 Atlantic Biologi
cals Corps DOCUSATE SODIUM 250 mg/1
17856-0490_ab07193f-6c9b-4fc5-8a0b-49c62e3b6268 17856-0490 HUMAN PRESCRIPTI
ON DRUG Hydrocodone Polistirex and Chlorpheniramine Polistirex Pennkinetic
hydrocodone bitartrate and chlorpheniramine maleate "SUSPENSION, EXTENDED RE
LEASE" ORAL 19871231 NDA AUTHORIZED GENERIC NDA019111
Atlantic Biologicals Corps CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE
8; 10 mg/5mL; mg/5mL "Opioid Agonist [EPC],Opioid Agonists [MoA],Histamine H1
Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]" CIII
17856-0604_f9917f94-1268-42fb-ba0e-75e11c19ba8a 17856-0604 HUMAN PRESCRIPTI
ON DRUG Dextromethorphan Hydrobromide and Promethazine Hydrochloride
Dextromethorphan Hydrobromide and Promethazine Hydrochloride SYRUP ORAL
DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE 15; 6.25
mg/5mL; mg/5mL "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Si
gma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Recept
or Agonists [MoA],Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient]"
17856-0608_0e49ffbd-9e5a-469b-ba93-379548af10b9 17856-0608 HUMAN PRESCRIPTI
SYRUP ORAL 19821115 ANDA ANDA087953 Atlantic Biologi
cals Corps PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL "Phenothiazine [
17856-0618_8f9655ba-3bea-4a51-9a5d-4dcd3c34f185 17856-0618 HUMAN OTC DRUG
Loperamide Hydrochloride Loperamide Hydrochloride SOLUTION
ORAL 19951117 ANDA ANDA074352 Atlantic Biologicals Cor
ps LOPERAMIDE HYDROCHLORIDE 1 mg/5mL
17856-0644_a2be0daf-8d5e-469f-a61b-cfcee7a19c16 17856-0644 HUMAN PRESCRIPTI
ON DRUG ELIXOPHYLLIN THEOPHYLLINE ANHYDROUS LIQUID ORAL 20091001
ANDA ANDA085186 Atlantic Biologicals Corps THEOPHYLLINE ANHYDROUS
80 mg/15mL "Methylxanthine [EPC],Xanthines [Chemical/Ingredient]"
17856-0664_9d0f743b-84a7-4258-93d6-4ab6b573e400 17856-0664 HUMAN PRESCRIPTI
ANDA ANDA078312 Atlantic Biologicals Corps RANITIDINE HYDROCHLORIDE
tagonist [EPC]"
17856-0668_53134984-468f-4913-982c-30f895aa6154 17856-0668 HUMAN PRESCRIPTI
ON DRUG PRENATAL PLUS "VITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC AC
ID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBO
FLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCI
UM CARBONATE, FERROUS FUMARATE, ZINC OXIDE, CUPRIC OXIDE" "TABLET, FILM CO
ATED" ORAL 20091202 UNAPPROVED DRUG OTHER Atlantic
Biologicals Corps ".ALPHA.-TOCOPHEROL ACETATE, DL-; .BETA.-CAROTENE; ASCOR
BIC ACID; CALCIUM CARBONATE; CHOLECALCIFEROL; CUPRIC OXIDE; CYANOCOBALAMIN; FERR
OUS FUMARATE; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THI
AMINE MONONITRATE; VITAMIN A ACETATE; ZINC OXIDE" 22; 920; 120; 200; 400;
2; 12; 27; 1; 20; 10; 3; 1.84; 3080; 25 mg/1; [iU]/1; mg/1; mg/1; [iU]/1; mg/1;
ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1 "Vitamin A [Chemical/Ing
redient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin
B 12 [Chemical/Ingredient],Vitamin B12 [EPC]"
17856-0685_1b851ea3-1cfb-4477-b72d-e878a3519e16 17856-0685 HUMAN PRESCRIPTI
17856-0691_fc1901d0-7944-41d5-9f7d-aabe6785dabc 17856-0691 HUMAN PRESCRIPTI
ANDA ANDA091483 Atlantic Biologicals Corps ONDANSETRON HYDROCHLORID
E 4 mg/5mL "Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Rece
ptor Antagonist [EPC]"
17856-0759_fa49330e-8ce4-4d79-b870-e22b7a0fc709 17856-0759 HUMAN PRESCRIPTI
ON DRUG Prednisolone Sodium Phosphate Prednisolone Sodium Phosphate
SOLUTION ORAL 20050525 ANDA ANDA076913 Atlantic
Biologicals Corps PREDNISOLONE SODIUM PHOSPHATE 15 mg/5mL "Cortico
17856-0775_97c0bf7b-49ca-47d6-a034-0d8ddcc43354 17856-0775 HUMAN PRESCRIPTI
ORAL; TOPICAL 19950710 ANDA ANDA040014 Atlantic Biologi
cals Corps LIDOCAINE HYDROCHLORIDE 20 mg/mL "Amide Local Anesthetic
17856-0788_88f9cba9-e8a2-4ea7-89ce-dbb906b7d175 17856-0788 HUMAN OTC DRUG
MILK OF MAGNESIA ORIGINAL magnesium hydroxide LIQUID ORAL
20101208 OTC MONOGRAPH FINAL part334 Atlantic Biologicals Cor
ps MAGNESIUM HYDROXIDE 1200 mg/15mL
17856-0792_ecfe5102-f404-416a-a0c1-a798f9446642 17856-0792 HUMAN PRESCRIPTI
ON DRUG Valproic Acid Valproic Acid SOLUTION ORAL 19950113
ANDA ANDA074060 Atlantic Biologicals Corps VALPROIC ACID 250
17856-0804_bac94880-a702-43e3-ba7e-0c62928a0c31 17856-0804 HUMAN PRESCRIPTI
ON DRUG Promethazine Hydrochloride and Codeine Phosphate Prometha
zine Hydrochloride and Codeine Phosphate SYRUP ORAL 19970826
ANDA ANDA040151 Atlantic Biologicals Corps CODEINE PHOSPHATE; PROME
THAZINE HYDROCHLORIDE 10; 6.25 mg/5mL; mg/5mL "Phenothiazine [EPC],Phe
nothiazines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC
]" CV
17856-0823_68dd81d9-4a49-4eec-94fb-5a8ddb38b079 17856-0823 HUMAN PRESCRIPTI
methoprim SUSPENSION ORAL 19971229 ANDA ANDA0746
50 Atlantic Biologicals Corps SULFAMETHOXAZOLE; TRIMETHOPRIM 200; 40
mg/5mL; mg/5mL "Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredie
17856-0865_867f210f-d85c-4e78-b8a0-cf5d05416227 17856-0865 HUMAN PRESCRIPTI
17856-0907_23be6d9b-9f77-413c-aa1a-9e295b5844ca 17856-0907 HUMAN PRESCRIPTI
ON DRUG Megestrol Acetate Megestrol Acetate SUSPENSION
ORAL 20010725 ANDA ANDA075671 Atlantic Biologicals Cor
ps MEGESTROL ACETATE 40 mg/mL "Progesterone Congeners [Chemica
l/Ingredient],Progestin [EPC]"
17856-0949_bcb4eb8f-40da-47b5-9061-dbc973467acb 17856-0949 HUMAN PRESCRIPTI
ON DRUG Megace ES megesterol acetate SUSPENSION ORAL
20050702 NDA NDA021778 Atlantic Biologicals Corps
MEGESTROL ACETATE 125 mg/mL "Progesterone Congeners [Chemical/Ingred
ient],Progestin [EPC]"
17856-1000_e57f9a0b-fff5-437e-a875-7a105de8fd09 17856-1000 HUMAN OTC DRUG
Senexon Sennosides A and B SYRUP ORAL 20130215
OTC MONOGRAPH NOT FINAL part334 Atlantic Biologicals Corps SENNOSIDES A AND
B 8.8 mg/5mL
17856-1161_51e22cd5-db35-4414-9944-bfe20048a545 17856-1161 HUMAN PRESCRIPTI
ON DRUG dicyclomine hydrochloride dicyclomine hydrochloride
SOLUTION ORAL 20050623 ANDA ANDA040169 Atlantic
Biologicals Corps DICYCLOMINE HYDROCHLORIDE 10 mg/5mL "Anticho
linergic [EPC],Cholinergic Antagonists [MoA]"
17856-1206_c409a22d-9e77-4cf5-b8db-3d2f0d544fa1 17856-1206 HUMAN PRESCRIPTI
ORAL 20100813 NDA NDA020725 Atlantic Biologicals Cor
ps PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE
30000; 6000; 19000 [USP'U]/1; [USP'U]/1; [USP'U]/1
17856-1212_a5708817-22eb-45e9-a444-2b28f709201b 17856-1212 HUMAN PRESCRIPTI
60000; 12000; 38000 [USP'U]/1; [USP'U]/1; [USP'U]/1
17856-1224_c2989de9-dfa7-4470-8d03-cc40b849b3cc 17856-1224 HUMAN PRESCRIPTI
120000; 24000; 76000 [USP'U]/1; [USP'U]/1; [USP'U]/1
17856-1295_21db67fa-0781-4ddf-9f3a-a72bc0349543 17856-1295 HUMAN PRESCRIPTI
rtrate and Acetaminophen SOLUTION ORAL 20031030
ANDA ANDA040520 Atlantic Biologicals Corps ACETAMINOPHEN; HYDROCODO
NE BITARTRATE 500; 7.5 mg/15mL; mg/15mL "Opioid Agonist [EPC],Op
17856-1313_97277c5f-34bd-4e1b-adee-422d78bb6f03 17856-1313 HUMAN OTC DRUG
Bismatrol Bismuth Subsalicylate LIQUID ORAL 20080530
OTC MONOGRAPH FINAL part335 Atlantic Biologicals Corps BISMUTH SUBSALIC
YLATE 262 mg/15mL
17856-1378_f2fb27c9-8d75-4df6-ae4e-ab68d06125b1 17856-1378 HUMAN PRESCRIPTI
ON DRUG Lactulose lactulose SOLUTION ORAL 20010726
ANDA ANDA075993 Atlantic Biologicals Corps LACTULOSE 10
g/15mL "Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA]
,Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"
17856-1508_0bdcd8b2-ccbb-4148-ba72-d066dbf8f4ca 17856-1508 HUMAN PRESCRIPTI
ON DRUG Phenobarbital phenobarbital ELIXIR ORAL 19970101
UNAPPROVED DRUG OTHER Atlantic Biologicals Corps PHENOBARBITAL
20 mg/5mL CIV
17856-1585_482db043-19a2-486d-9dee-63a1fe4d49fc 17856-1585 HUMAN PRESCRIPTI
50 Atlantic Biologicals Corps CODEINE PHOSPHATE; PROMETHAZINE HYDROCHL
ORIDE 10; 6.25 mg/5mL; mg/5mL "Full Opioid Agonists [MoA],Opioid Agoni
st [EPC],Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient]" CV
17856-2001_2d021355-eb05-1843-39c5-1f2e5c02a82e 17856-2001 HUMAN PRESCRIPTI
ON DRUG Chlorhexidine Gluconate Chlorhexidine Gluconate RINSE ORAL
CHLORHEXIDINE GLUCONATE 0.12 mg/mL Decreased Cell Wall Integrity [PE]
17856-2002_2d021355-eb05-1843-39c5-1f2e5c02a82e 17856-2002 HUMAN PRESCRIPTI
17856-2002_2d38d4dc-d107-a4f8-0cc9-844e1391396d 17856-2002 HUMAN PRESCRIPTI
17856-3188_42034081-428c-1b3d-5062-ed0c8f970609 17856-3188 HUMAN PRESCRIPTI
ON DRUG Diazepam Diazepam SOLUTION ORAL 19870403
ANDA ANDA070928 Atlantic Biologicals Corps DIAZEPAM 5
mg/5mL "Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]" CIV
17856-4069_ed7c1cbc-6b29-4419-9ca6-e4bf17a41313 17856-4069 HUMAN PRESCRIPTI
ANDA ANDA040521 Atlantic Biologicals Corps PHENYTOIN 125
17856-4091_25fc2f67-72d9-4170-ac0c-5519cfed31bc 17856-4091 HUMAN PRESCRIPTI
ANDA ANDA091483 Atlantic Biologicals Corps ONDANSETRON HYDROCHLORID
E 4 mg/5mL "Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Rece
ptor Antagonist [EPC]"
17856-5180_12eab105-e605-4010-8be9-850f593ac064 17856-5180 HUMAN OTC DRUG
Tussin Sugar Free Cough "Dextromethorphan Hydrobromide, GUAIFENESIN"
LIQUID ORAL 20090107 OTC MONOGRAPH FINAL part341 Atlantic
Biologicals Corps DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100
mg/5mL; mg/5mL
17856-5309_1906658a-aacd-49da-9522-8405a79c3d7d 17856-5309 HUMAN OTC DRUG
Ibuprofen Ibuprofen SUSPENSION ORAL 19990207
ANDA ANDA074937 Atlantic Biologicals Corps IBUPROFEN 100
mg/5mL
17856-5721_f944afac-f5ca-45a4-8953-155d0d229789 17856-5721 HUMAN OTC DRUG
MINTOX "aluminum hydroxide, magnesium hydroxide, dimethicone" SUSPENSI
ON ORAL 20110201 OTC MONOGRAPH FINAL part331 Atlantic
Biologicals Corps ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE
200; 20; 200 mg/5mL; mg/5mL; mg/5mL
17856-5725_b67051cf-8977-4df0-8078-7c72000e57c6 17856-5725 HUMAN OTC DRUG
MINTOX MAXIMUM STRENGTH "aluminum hydroxide, magnesium hydroxide, dimeth
icone" SUSPENSION ORAL 20110201 OTC MONOGRAPH FINAL
part331 Atlantic Biologicals Corps ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESI
UM HYDROXIDE 400; 40; 400 mg/5mL; mg/5mL; mg/5mL
57728-0001_89343176-23ba-468d-9bf0-2a0dd9af19f4 57728-0001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS Atlantic Medical Inc. OXYGEN 99 L/100L
64650-345_dac3bce9-9e22-4309-a6a9-e0495e328299 64650-345 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS Atlantic Welding Supply OXYGEN 99 L/100L
53200-001_a5d9e551-6401-4b22-b7fc-92031b40c295 53200-001 HUMAN PRESCRIPTI
ON DRUG Derma Numb Lidocaine HCI SPRAY TOPICAL 20120715
OTC MONOGRAPH FINAL part348 Atlas Tat Inc. LIDOCAINE HYDROCHLORIDE 40
mg/g "Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmi
53200-001_e28834f3-99dc-40a7-9e11-d71d0dc7d317 53200-001 HUMAN OTC DRUG
Derma Numb Lidocaine SPRAY TOPICAL 20120715
OTC MONOGRAPH FINAL part348 Atlas Tat Inc. LIDOCAINE 40 mg/g
53200-005_2b893b24-c1b5-41b3-9950-c09a94bd9848 53200-005 HUMAN OTC DRUG
Derma Numb Lidocaine SPRAY TOPICAL 20140806
OTC MONOGRAPH NOT FINAL part348 Atlas Tat Inc. LIDOCAINE 50 mg/g
50699-1072_a6a1f0c9-cf22-43b1-9cbc-9f27fec9c225 50699-1072 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS "Atlas Welding Supply Co., Inc." OXYGEN
99 L/100L
59702-150_9192ed6e-3383-4147-a2bd-796562cd81eb 59702-150 HUMAN PRESCRIPTI
ON DRUG Zonatuss benzonatate CAPSULE ORAL 20100226
ANDA ANDA040851 Atley Pharmaceuticals BENZONATATE 150 mg/1
ive [EPC]"
59702-674_1ec465dd-6c22-45d4-8ef2-3825d64d3088 59702-674 HUMAN PRESCRIPTI
ON DRUG Zolvit hydrocodone bitartrate and acetaminophen SOLUTION
ORAL 20101101 ANDA ANDA040881 Atley Pharmaceuticals
ACETAMINOPHEN; HYDROCODONE BITARTRATE 300; 10 mg/15mL; mg/15mL "Opioid
59702-661_d3c69436-a681-4e00-8db0-8cbfaac9627e 59702-661 HUMAN PRESCRIPTI
ON DRUG ORBIVAN "Butalbital, Acetaminophen, and Caffeine" CAPSULE
ORAL 20100423 ANDA ANDA040885 "Atley Pharmaceuticals,
Inc." ACETAMINOPHEN; BUTALBITAL; CAFFEINE 300; 50; 40 mg/1; mg/1; mg/1
"Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Sti
mulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthi
nes [Chemical/Ingredient]" CIII
59702-800_9d58e774-94a9-4007-880d-003ef41dfc56 59702-800 HUMAN PRESCRIPTI
ON DRUG Atuss DS Tannate Suspension Tannate Suspension SUSPENSI
ON ORAL 20061121 UNAPPROVED DRUG OTHER "Atley P
harmaceuticals, Inc." CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE;
PSEUDOEPHEDRINE HYDROCHLORIDE 4; 30; 30 mg/5mL; mg/5mL; mg/5mL "Uncompe
titive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Unco
mpetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA],Adrene
rgic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC],Histamine H1 Receptor A
ntagonists [MoA],Histamine-1 Receptor Antagonist [EPC]"
52257-1001_edaef150-ae1a-4b6b-8058-a9b478cf6c20 52257-1001 HUMAN OTC DRUG
ATOMY SUN CREAM SPF 50 PA OCTINOXATE CREAM TOPICAL 20100428
OTC MONOGRAPH NOT FINAL part352 ATOMY CO LTD OCTINOXATE; OCTISALATE; TITANIUM
DIOXIDE; ZINC OXIDE 4.5; 3; 1.5; 2.9 mL/60mL; mL/60mL; mL/60mL; mL/60
mL
52257-1002_6a66799a-c889-4a45-aefc-f12dd55349d6 52257-1002 HUMAN OTC DRUG
ATOMY BB CREAM SPF 30 PA OCTINOXATE CREAM TOPICAL 20100429
OTC MONOGRAPH NOT FINAL part352 ATOMY CO LTD OCTINOXATE; TITANIUM DIOXIDE; ZI
NC OXIDE 1.2; 3.2; .78 mL/40mL; mL/40mL; mL/40mL
52257-1003_9d1738e0-b637-4c23-8935-86295173b1f8 52257-1003 HUMAN OTC DRUG
ATOMY TOOTHPASTE SODIUM FLUORIDE "PASTE, DENTIFRICE" DENTAL
20100525 OTC MONOGRAPH FINAL part355 ATOMY CO LTD SODIUM F
LUORIDE; SODIUM MONOFLUOROPHOSPHATE .2; .32 g/200g; g/200g
52257-1004_2ad667b8-581e-40da-9de8-331491c9f6f2 52257-1004 HUMAN OTC DRUG
ATOMY HERBAL HAIR TONIC DEXPANTHENOL LIQUID TOPICAL 20100429
UNAPPROVED DRUG OTHER ATOMY CO LTD DEXPANTHENOL; LEVOMENTHOL; SALIC
YLIC ACID .4; .6; .5 mL/200mL; mL/200mL; mL/200mL
52257-1100_a0c66b35-53ec-4bdd-98ce-75f2b74f59f1 52257-1100 HUMAN OTC DRUG
Fresh Med Solution "GLYCERIN, ALCOHOL, GLYCERYL MONOSTEARATE"
LIQUID TOPICAL 20110718 OTC MONOGRAPH FINAL part347 ATOMY CO
LTD ALCOHOL; GLYCERIN; GLYCERYL MONOSTEARATE 1.6; 1.744; .4 mL/40mL;
mL/40mL; mL/40mL
52257-1110_6eca6fb4-d4e6-4dc4-95a8-8006cfdbef08 52257-1110 HUMAN OTC DRUG
Calming Skin "PANTHENOL, GLYCERIN, TOCOPHEROL" LOTION TOPICAL
20110718 UNAPPROVED DRUG OTHER ATOMY CO LTD GLYCERIN
; PANTHENOL; TOCOPHEROL .65; .65; .65 mL/130mL; mL/130mL; mL/130mL
52257-1200_b0874195-4256-4436-817d-818b4d0ba1c3 52257-1200 HUMAN OTC DRUG
ATOMY MINERAL PACT SPF35 PA PLUS PLUS NO.13 "TITANIUM DIOXIDE, ZINC
OXIDE" POWDER TOPICAL 20100429 OTC MONOGRAPH FINAL part352
"ATOMY CO., LTD." TITANIUM DIOXIDE; ZINC OXIDE 2.2; .23 g/12g; g
/12g
52257-1201_568f0324-2bcd-4e4a-afcd-657937e00e6f 52257-1201 HUMAN OTC DRUG
/12g
52257-1202_a1bfd1f4-4c95-4620-8664-4624de7b9d6b 52257-1202 HUMAN OTC DRUG
/12g
52257-1203_e8661940-0ebf-4d78-b43b-a9d4e5fe8276 52257-1203 HUMAN OTC DRUG
ATOMY SUN SPF50 PLUS PA PLUS PLUS PLUS "OCTINOXATE, OCTISALATE, ZINC OX
IDE, TITANIUM DIOXIDE" CREAM TOPICAL 20100428 OTC MONOGRAPH FI
NAL part352 "ATOMY CO., LTD." OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE
; ZINC OXIDE 4.5; 3; 1.49; 2.88 mL/60mL; mL/60mL; mL/60mL; mL/60mL
52257-1204_9231064f-675b-4b73-9c4f-b1329bf81d3a 52257-1204 HUMAN OTC DRUG
ATOMY SUN BEIGE SPF50 PLUS PA PLUS PLUS PLUS "OCTINOXATE, OCTISALATE,
ZINC OXIDE, TITANIUM DIOXIDE" CREAM TOPICAL 20100428 OTC MONO
GRAPH FINAL part352 "ATOMY CO., LTD." OCTINOXATE; OCTISALATE; TITANIUM
DIOXIDE; ZINC OXIDE 4.5; 3; 1.49; 2.94 mL/60mL; mL/60mL; mL/60mL; mL/60
mL
52257-1205_525b39df-b72b-4c85-9b5e-892740605659 52257-1205 HUMAN OTC DRUG
/12g
52257-1206_682caafa-9c60-4b07-8058-3132c1724e2c 52257-1206 HUMAN OTC DRUG
ATOMY BB SPF30 PA PLUS PLUS "TITANIUM DIOXIDE, OCTINOXATE, ZINC OXID
E" CREAM TOPICAL 20100429 OTC MONOGRAPH FINAL part352
"ATOMY CO., LTD." OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.2; 3.1
68; .768 mL/40mL; mL/40mL; mL/40mL
52257-1208_a47b5a6d-b4fc-41b4-ba7a-df0b33cadc05 52257-1208 HUMAN OTC DRUG
PROPOLIS 50g SODIUM MONOFLUOROPHOSPHATE "PASTE, DENTIFRICE"
DENTAL 20100525 OTC MONOGRAPH FINAL part355 "ATOMY CO., LTD.
" SODIUM FLUORIDE; SODIUM MONOFLUOROPHOSPHATE .05; .08 g/50g; g
/50g
52257-1209_be3364e4-db4f-40bc-8f48-f65723ec9f98 52257-1209 HUMAN OTC DRUG
PROPOLIS 200g "SODIUM MONOFLUOROPHOSPHATE, SODIUM FLUORIDE" "PASTE,
"ATOMY CO., LTD." SODIUM FLUORIDE; SODIUM MONOFLUOROPHOSPHATE .2; .32
g/200g; g/200g
52257-1210_dbe504f6-c10f-4e78-bd96-ffadf7e4a12d 52257-1210 HUMAN OTC DRUG
Atomy Sunscreen Beige SPF50 PLUS "Octinoxate, Octisalate, Zinc Oxide, Tit
anium Dioxide" CREAM TOPICAL 20130201 OTC MONOGRAPH NOT FINAL
part352 "ATOMY CO., LTD." OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC O
XIDE 4.08; 2.7; 2.92; 8.06 mg/60mL; mg/60mL; mg/60mL; mg/60mL
52257-1220_70512bc8-79f3-4ac5-8218-171eb42a9ac3 52257-1220 HUMAN OTC DRUG
Atomy Sunscreen White SPF50 PLUS "Octinoxate, Octisalate, Zinc Oxide, Tit
part352 "ATOMY CO., LTD." OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC O
XIDE 4.08; 2.7; 2.92; 8.06 mg/60mL; mg/60mL; mg/60mL; mg/60mL
52257-1230_7f22847b-73a5-411a-a936-2d40186ec806 52257-1230 HUMAN OTC DRUG
ATOMY SUNSCREEN BEIGE Broad Spectrum SPF50 Plus "Octinoxate, Octisalate, Zinc Ox
ide, Titanium Dioxide" CREAM TOPICAL 20130201 OTC MONOGRAPH NO
T FINAL part352 "ATOMY CO., LTD." OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE
; ZINC OXIDE 4.08; 2.7; 2.92; 8.06 mg/60mL; mg/60mL; mg/60mL; mg/60mL
52257-1240_f8cebb6d-a93e-4192-8b34-c6dde8608ba2 52257-1240 HUMAN OTC DRUG
ATOMY SUNSCREEN WHITE Broad Spectrum SPF50 Plus "Octinoxate, Octisalate, Zinc Ox
ide, Titanium Dioxide" CREAM TOPICAL 20130201 OTC MONOGRAPH NO
T FINAL part352 "ATOMY CO., LTD." OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE
; ZINC OXIDE 4.08; 2.7; 2.92; 8.06 mg/60mL; mg/60mL; mg/60mL; mg/60mL
52257-1250_7cbc45a2-63b2-4d67-8093-0b78abe2d0c1 52257-1250 HUMAN OTC DRUG
ATOMY BB BROAD SPECTRUM SPF30 "TITANIUM DIOXIDE, OCTINOXATE, ZINC OXID
E" CREAM TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part352
"ATOMY CO., LTD." OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.4; 3.1
6; .76 mg/40mL; mg/40mL; mg/40mL
25010-711_b3e18113-1156-4995-a7b6-0481b62cdcac 25010-711 HUMAN PRESCRIPTI
ON DRUG Lodosyn carbidopa TABLET ORAL 20100413
NDA NDA017830 "Aton Pharma, Inc" CARBIDOPA 25 mg/1
25010-205_1de68a55-e246-4b47-a15a-f848963febd2 25010-205 HUMAN PRESCRIPTI
ON DRUG EDECRIN ethacrynic acid TABLET ORAL 19670110 20141231
NDA NDA016092 "Aton Pharma, Inc." ETHACRYNIC ACID 25 mg/1
"Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC]"
25010-210_d07c54fb-af1e-4cb9-83a7-8a191d5aea25 25010-210 HUMAN PRESCRIPTI
ON DRUG Sodium Edecrin ethacrynate sodium "POWDER, FOR SOLUTION"
INTRAVENOUS 19670110 NDA NDA016093 "Aton Pharma, In
c." ETHACRYNATE SODIUM 50 mg/50mL "Increased Diuresis at Loop of H
enle [PE],Loop Diuretic [EPC]"
25010-215_9187708f-cc7b-4fe9-828e-9a77e98354ad 25010-215 HUMAN PRESCRIPTI
ON DRUG EDECRIN ethacrynic acid TABLET ORAL 19670110
NDA NDA016092 "Aton Pharma, Inc." ETHACRYNIC ACID 25 mg/1
"Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC]"
25010-305_90965385-d7cf-4d26-8ed6-7c9b2558324d 25010-305 HUMAN PRESCRIPTI
ON DRUG Demser metyrosine CAPSULE ORAL 19791003
NDA NDA017871 "Aton Pharma, Inc." METYROSINE 250 mg/1
"Catecholamine Synthesis Inhibitor [EPC],Catecholamine Synthesis Inhibitors [MoA
]"
25010-705_f65a25e2-f6eb-4830-83b6-bb98946b5a8d 25010-705 HUMAN PRESCRIPTI
ON DRUG Cuprimine Penicillamine CAPSULE ORAL 19701204
NDA NDA019853 "Aton Pharma, Inc." PENICILLAMINE 250 mg/1
25010-710_66ac38dc-4625-41ac-bc3f-9363b930c33d 25010-710 HUMAN PRESCRIPTI
ON DRUG Syprine trientine hydrochloride CAPSULE ORAL 19851108
NDA NDA019194 "Aton Pharma, Inc." TRIENTINE HYDROCHLORIDE 250
mg/1 "Metal Chelating Activity [MoA],Metal Chelator [EPC]"
25010-805_af8bba8c-4791-438a-af06-8eea9f704da5 25010-805 HUMAN PRESCRIPTI
ON DRUG Lacrisert hydroxypropyl cellulose PELLET OPHTHALMIC
19810601 NDA NDA018771 "Aton Pharma, Inc." HYDROXYP
ROPYL CELLULOSE (TYPE H) 5 mg/1 "Demulcent [EPC],Demulcent Activ
ity [MoA]"
25010-810_de10a629-46c2-493f-b44e-3f555028df7d 25010-810 HUMAN PRESCRIPTI
ON DRUG Timoptic-XE Timolol Maleate SOLUTION OPHTHALMIC
19931114 NDA NDA020330 "Aton Pharma, Inc." TIMOLOL
MALEATE 2.5 mg/mL
25010-811_de10a629-46c2-493f-b44e-3f555028df7d 25010-811 HUMAN PRESCRIPTI
ON DRUG Timoptic-XE Timolol Maleate SOLUTION OPHTHALMIC
MALEATE 5 mg/mL
25010-812_2da4053f-96c8-4e40-ad53-c925447ce882 25010-812 HUMAN PRESCRIPTI
ON DRUG Timoptic Timolol Maleate SOLUTION OPHTHALMIC
MALEATE 2.5 mg/mL "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Block
er [EPC]"
25010-813_2da4053f-96c8-4e40-ad53-c925447ce882 25010-813 HUMAN PRESCRIPTI
MALEATE 5 mg/mL "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Block
er [EPC]"
25010-814_0f32f82b-4e6e-4958-9124-f97451ae3e20 25010-814 HUMAN PRESCRIPTI
MALEATE 2.5 mg/mL
25010-815_0f32f82b-4e6e-4958-9124-f97451ae3e20 25010-815 HUMAN PRESCRIPTI
MALEATE 5 mg/mL
25010-816_5b7cff7d-8876-4eb1-aab7-8efebc61deec 25010-816 HUMAN PRESCRIPTI
MALEATE 3.4 mg/mL
25010-817_5b7cff7d-8876-4eb1-aab7-8efebc61deec 25010-817 HUMAN PRESCRIPTI
MALEATE 6.8 mg/mL
42853-102_2c3257ea-c42e-43ec-b1ec-755e9dd7b6f3 42853-102 HUMAN OTC DRUG
ALL-IN-ONE BENZOYL PEROXIDE CREAM TOPICAL 20120225
OTC MONOGRAPH FINAL part333D AUGUSTUS BIOMED LLC BENZOYL PEROXIDE
5.5 g/100mL
65862-001_3998ef72-47af-45a6-805d-33e5b53c0959 65862-001 HUMAN PRESCRIPTI
20041022 ANDA ANDA076921 Aurobindo Pharma Limited
MIRTAZAPINE 7.5 mg/1
MIRTAZAPINE 30 mg/1
65862-005_16a23137-4099-484f-8a96-cb3f40faf72f 65862-005 HUMAN PRESCRIPTI
ORAL 20041028 ANDA ANDA077031 Aurobindo Pharma Limited
65862-008_9fd175ae-ef61-47e9-94af-2c9fbfcbf129 65862-008 HUMAN PRESCRIPTI
ATED" ORAL 20050114 ANDA ANDA077095 Aurobindo Pharma
Limited METFORMIN HYDROCHLORIDE 500 mg/1 "Biguanide [EPC],Biguani
65862-011_be220b11-4a41-4d98-904b-6749c83db10e 65862-011 HUMAN PRESCRIPTI
Aurobindo Pharma Limited SERTRALINE HYDROCHLORIDE 25 mg/1
65862-014_df173f23-41e7-44b5-bd87-e6e403c249ab 65862-014 HUMAN PRESCRIPTI
65862-015_df173f23-41e7-44b5-bd87-e6e403c249ab 65862-015 HUMAN PRESCRIPTI
65862-016_0cd3c501-ef2a-4b96-817f-6943bd433234 65862-016 HUMAN PRESCRIPTI
ANDA ANDA065271 Aurobindo Pharma Limited AMOXICILLIN 250
65862-017_0cd3c501-ef2a-4b96-817f-6943bd433234 65862-017 HUMAN PRESCRIPTI
ANDA ANDA065271 Aurobindo Pharma Limited AMOXICILLIN 500
65862-018_dedda4db-1c41-4fe9-b227-7cad3cc8a153 65862-018 HUMAN PRESCRIPTI
ANDA ANDA065253 Aurobindo Pharma Limited CEPHALEXIN 250
65862-019_dedda4db-1c41-4fe9-b227-7cad3cc8a153 65862-019 HUMAN PRESCRIPTI
ANDA ANDA065253 Aurobindo Pharma Limited CEPHALEXIN 500
65862-021_10921342-1ee6-4276-bc76-19f139e4e29e 65862-021 HUMAN PRESCRIPTI
ON DRUG Mirtazapine Mirtazapine "TABLET, ORALLY DISINTEGRATING"
MIRTAZAPINE 15 mg/1
MIRTAZAPINE 30 mg/1
MIRTAZAPINE 45 mg/1
65862-024_0f00e17d-fbd2-4a51-8b9a-b320f255060c 65862-024 HUMAN PRESCRIPTI
ON DRUG Zidovudine Zidovudine "TABLET, FILM COATED" ORAL
ZIDOVUDINE 300 mg/1 "Human Immunodeficiency Virus Nucleoside Analog
65862-027_2e39c203-406c-4959-8f57-c4252574fc48 65862-027 HUMAN PRESCRIPTI
ANDA ANDA077521 Aurobindo Pharma Limited NEVIRAPINE 200
mg/1 "Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcript
ase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside R
everse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochro
me P450 2B6 Inducers [MoA]"
65862-028_978e4f41-adc8-478d-bd0f-bde8bf36dbd5 65862-028 HUMAN PRESCRIPTI
ANDA ANDA077537 Aurobindo Pharma Limited GLYBURIDE 1.25
ANDA ANDA077537 Aurobindo Pharma Limited GLYBURIDE 2.5
ANDA ANDA077537 Aurobindo Pharma Limited GLYBURIDE 5
MIRTAZAPINE 15 mg/1
MIRTAZAPINE 45 mg/1
65862-033_3cde9401-2a6a-44af-826c-61e61fceaed6 65862-033 HUMAN PRESCRIPTI
ON DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET ORAL
20060329 20160131 ANDA ANDA065308 Aurobindo Pharma Limited
65862-037_9ae9f616-bda7-4e88-be8c-58a4ed35c569 65862-037 HUMAN PRESCRIPTI
ANDA ANDA077622 Aurobindo Pharma Limited LISINOPRIL 2.5
ANDA ANDA077622 Aurobindo Pharma Limited LISINOPRIL 5
65862-043_5dc999d9-1620-4e85-8db0-4ccd2e8a0179 65862-043 HUMAN PRESCRIPTI
Aurobindo Pharma Limited HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10
rting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Th
iazides [Chemical/Ingredient]"
Aurobindo Pharma Limited HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20
rting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Th
iazides [Chemical/Ingredient]"
Aurobindo Pharma Limited HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg
zyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides
65862-046_2bc2dece-297b-48e7-a71a-b516ec412fc8 65862-046 HUMAN PRESCRIPTI
ON DRUG Stavudine Stavudine CAPSULE ORAL 20081229
ANDA ANDA077672 Aurobindo Pharma Limited STAVUDINE 30
65862-048_b729df9f-6402-4904-b6a8-68688affc57f 65862-048 HUMAN PRESCRIPTI
ON DRUG Zidovudine Zidovudine SYRUP ORAL 20050919
ANDA ANDA077268 Aurobindo Pharma Limited ZIDOVUDINE 10
mg/mL "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase In
65862-050_d759bae3-dc70-4a17-91fc-4aab8cc9f5d7 65862-050 HUMAN PRESCRIPTI
65862-057_527ac278-3591-4499-a050-0cb21be635d1 65862-057 HUMAN PRESCRIPTI
ON DRUG Nevirapine Nevirapine SUSPENSION ORAL 20120522
ANDA ANDA077702 Aurobindo Pharma Limited NEVIRAPINE HEMIHYDRATE
50 mg/5mL "Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Tr
anscriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucl
eoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],
Cytochrome P450 2B6 Inducers [MoA]"
65862-058_be621161-d8b7-4ea5-87f9-8a8a810611ed 65862-058 HUMAN PRESCRIPTI
ANDA ANDA077731 Aurobindo Pharma Limited FLUCONAZOLE 50
bitors [MoA]"
bitors [MoA]"
bitors [MoA]"
bitors [MoA]"
65862-062_ed54e752-ed01-44f8-8ded-26e8ed2b81be 65862-062 HUMAN PRESCRIPTI
Limited METOPROLOL TARTRATE 25 mg/1 "Adrenergic beta-Antagon
65862-068_c898671e-f22a-4ee2-8bf5-9f7de34f273c 65862-068 HUMAN PRESCRIPTI
CEFPROZIL 250 mg/1
65862-069_c898671e-f22a-4ee2-8bf5-9f7de34f273c 65862-069 HUMAN PRESCRIPTI
CEFPROZIL 500 mg/1
65862-070_e6e6e42f-fa47-49a3-9fb4-53e893141107 65862-070 HUMAN PRESCRIPTI
AMOXICILLIN 200 mg/5mL "Penicillin-class Antibacterial [EPC],Penicillin
65862-071_e6e6e42f-fa47-49a3-9fb4-53e893141107 65862-071 HUMAN PRESCRIPTI
AMOXICILLIN 400 mg/5mL "Penicillin-class Antibacterial [EPC],Penicillin
65862-072_f9c53576-42be-42a7-a9c3-ad7a75ac2dd9 65862-072 HUMAN PRESCRIPTI
ON DRUG Stavudine Stavudine "POWDER, FOR SOLUTION" ORAL
STAVUDINE 1 mg/mL "Human Immunodeficiency Virus Nucleoside Analog
65862-073_44418f84-519a-4c0c-b2a8-7cce684f8b3e 65862-073 HUMAN PRESCRIPTI
ON DRUG Abacavir Abacavir Sulfate "TABLET, FILM COATED"
ABACAVIR SULFATE 300 mg/1 "Human Immunodeficiency Virus Nucleoside
65862-074_168212d5-16e7-4dd6-85ac-a5a7b27dda6e 65862-074 HUMAN PRESCRIPTI
ON DRUG Citalopram Hydrobromide Citalopram Hydrobromide SOLUTION
CITALOPRAM HYDROBROMIDE 10 mg/5mL "Serotonin Reuptake Inhibitor [EPC],Sero
65862-076_81c6930b-305b-4331-b681-e675475935fa 65862-076 HUMAN PRESCRIPTI
ON DRUG Ciprofloxacin Ciprofloxacin Hydrochloride "TABLET, FILM CO
Limited CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 "Quinolone Antim
65862-079_c9bac2a8-eb1e-436a-a0db-d5ba1b132034 65862-079 HUMAN PRESCRIPTI
ON DRUG Terbinafine Terbinafine Hydrochloride TABLET ORAL
TERBINAFINE HYDROCHLORIDE 250 mg/1 "Allylamine [Chemical/Ingredient
],Allylamine Antifungal [EPC]"
65862-080_50e39a05-9386-40c1-9d5a-260f12106b67 65862-080 HUMAN PRESCRIPTI
ANDA077870 Aurobindo Pharma Limited GLYBURIDE; METFORMIN HYDROCHLORI
DE 1.25; 250 mg/1; mg/1 "Sulfonylurea [EPC],Sulfonylurea Compoun
ds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient]"
DE 2.5; 500 mg/1; mg/1 "Sulfonylurea [EPC],Sulfonylurea Compoun
ds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient]"
65862-083_d20b775d-86ca-4452-aebe-bee296b2ad88 65862-083 HUMAN PRESCRIPTI
ON DRUG Cefadroxil Cefadroxil "POWDER, FOR SUSPENSION"
CEFADROXIL 250 mg/5mL "Cephalosporin Antibacterial [EPC],Cephalosporin
65862-084_d20b775d-86ca-4452-aebe-bee296b2ad88 65862-084 HUMAN PRESCRIPTI
ON DRUG Cefadroxil Cefadroxil "POWDER, FOR SUSPENSION"
CEFADROXIL 500 mg/5mL "Cephalosporin Antibacterial [EPC],Cephalosporin
65862-085_54181b68-0f1d-4ee5-b5c9-7dc7ba2792d3 65862-085 HUMAN PRESCRIPTI
ANDA ANDA065352 Aurobindo Pharma Limited CEFADROXIL 500
65862-086_371a4508-05a0-442c-8328-59f9bec7ce10 65862-086 HUMAN PRESCRIPTI
ON DRUG Bisoprolol Fumarate Bisoprolol Fumarate "TABLET, FILM CO
Limited BISOPROLOL FUMARATE 5 mg/1 "Adrenergic beta-Antagon
65862-087_371a4508-05a0-442c-8328-59f9bec7ce10 65862-087 HUMAN PRESCRIPTI
ON DRUG Bisoprolol Fumarate Bisoprolol Fumarate "TABLET, FILM CO
Limited BISOPROLOL FUMARATE 10 mg/1 "Adrenergic beta-Antagon
65862-095_ed85f71c-b88f-4f40-a761-2ffb42847760 65862-095 HUMAN PRESCRIPTI
ON DRUG CEFPODOXIME PROXETIL CEFPODOXIME PROXETIL "TABLET, FILM CO
Limited CEFPODOXIME PROXETIL 100 mg/1 "Cephalosporin Antibacte
65862-096_ed85f71c-b88f-4f40-a761-2ffb42847760 65862-096 HUMAN PRESCRIPTI
ON DRUG CEFPODOXIME PROXETIL CEFPODOXIME PROXETIL "TABLET, FILM CO
Limited CEFPODOXIME PROXETIL 200 mg/1 "Cephalosporin Antibacte
65862-097_dbbdb14d-7f87-4c1f-8ce8-2fe6a8b3e43f 65862-097 HUMAN PRESCRIPTI
ANDA ANDA078008 Aurobindo Pharma Limited MELOXICAM 7.5
65862-098_dbbdb14d-7f87-4c1f-8ce8-2fe6a8b3e43f 65862-098 HUMAN PRESCRIPTI
ANDA ANDA078008 Aurobindo Pharma Limited MELOXICAM 15
65862-099_67ff380f-20d8-40b4-9be6-49a271317d91 65862-099 HUMAN PRESCRIPTI
ON DRUG Cefprozil Cefprozil "POWDER, FOR SUSPENSION"
CEFPROZIL 125 mg/5mL
65862-100_67ff380f-20d8-40b4-9be6-49a271317d91 65862-100 HUMAN PRESCRIPTI
ON DRUG Cefprozil Cefprozil "POWDER, FOR SUSPENSION"
CEFPROZIL 250 mg/5mL
65862-101_d301fd70-66b5-4370-95a5-6fbdd939862e 65862-101 HUMAN PRESCRIPTI
65862-107_4ce0cda4-c034-452c-bd8b-176c0a7032a4 65862-107 HUMAN PRESCRIPTI
ON DRUG Zidovudine Zidovudine CAPSULE ORAL 20060327
ANDA ANDA078128 Aurobindo Pharma Limited ZIDOVUDINE 100
65862-113_462822dd-695b-483c-8d4c-1ddf3b8763cd 65862-113 HUMAN PRESCRIPTI
ON DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE ORAL
HYDROCHLOROTHIAZIDE 12.5 mg/1 "Increased Diuresis [PE],Thiazide Diuret
65862-116_67d1b6c3-cefa-4dd1-bc4f-63045dd58909 65862-116 HUMAN PRESCRIPTI
Aurobindo Pharma Limited BENAZEPRIL HYDROCHLORIDE 10 mg/1
ibitors [MoA],Decreased Blood Pressure [PE]"
65862-119_cff62df3-22b7-4294-804b-5eb33216588b 65862-119 HUMAN PRESCRIPTI
ON DRUG Risperidone Risperidone "TABLET, FILM COATED" ORAL
65862-125_2f850d65-0d35-4b37-a75b-941738ca839c 65862-125 HUMAN PRESCRIPTI
ANDA ANDA078249 Aurobindo Pharma Limited TORSEMIDE 5
65862-133_2f459b7a-cd5b-4b5f-9be6-82f2f43badc8 65862-133 HUMAN PRESCRIPTI
65862-134_2f459b7a-cd5b-4b5f-9be6-82f2f43badc8 65862-134 HUMAN PRESCRIPTI
65862-140_4194738a-f0e0-4f19-926d-90f8e56539d8 65862-140 HUMAN PRESCRIPTI
ON DRUG Cefpodoxime Proxetil Cefpodoxime Proxetil "GRANULE, FOR SU
SPENSION" ORAL 20070608 ANDA ANDA065409 Aurobind
o Pharma Limited CEFPODOXIME PROXETIL 50 mg/5mL "Cephalosporin A
65862-141_4194738a-f0e0-4f19-926d-90f8e56539d8 65862-141 HUMAN PRESCRIPTI
ON DRUG Cefpodoxime Proxetil Cefpodoxime Proxetil "GRANULE, FOR SU
SPENSION" ORAL 20070608 ANDA ANDA065409 Aurobind
o Pharma Limited CEFPODOXIME PROXETIL 100 mg/5mL "Cephalosporin A
65862-142_ce81bafc-7ff5-44e9-8d09-fec771463b0e 65862-142 HUMAN PRESCRIPTI
65862-146_32969d2a-756f-4901-82b5-379e4c2e6eb8 65862-146 HUMAN PRESCRIPTI
ON DRUG Sumatriptan Sumatriptan Succinate TABLET ORAL 20090817
ANDA ANDA078327 Aurobindo Pharma Limited SUMATRIPTAN SUCCINATE
65862-146_57510ffd-33cc-4532-bc2a-877a784b015c 65862-146 HUMAN PRESCRIPTI
ON DRUG Sumatriptan Succinate Sumatriptan Succinate TABLET ORAL
SUMATRIPTAN SUCCINATE 25 mg/1 "Serotonin 1b Receptor Agonists [MoA],Se
t [EPC]"
t [EPC]"
t [EPC]"
65862-149_5998d047-1a16-44e2-89af-ed826347f4a2 65862-149 HUMAN PRESCRIPTI
65862-154_a187c8ee-8ed9-4f00-aaec-ee30f0977d2e 65862-154 HUMAN PRESCRIPTI
Limited PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 "Seroton
65862-158_454f5fe5-6a57-4099-b158-7edede8bfd10 65862-158 HUMAN PRESCRIPTI
ON DRUG carisoprodol carisoprodol TABLET ORAL 20090806
ANDA ANDA040792 Aurobindo Pharma Limited CARISOPRODOL 350
CIV
65862-159_9ab3eb39-256f-4740-b12e-078b6c061ae7 65862-159 HUMAN PRESCRIPTI
Limited ZOLPIDEM TARTRATE 5 mg/1 "gamma-Aminobutyric Acid
65862-160_9ab3eb39-256f-4740-b12e-078b6c061ae7 65862-160 HUMAN PRESCRIPTI
Limited ZOLPIDEM TARTRATE 10 mg/1 "gamma-Aminobutyric Acid
65862-161_9f26ea5e-8b75-46f4-bb80-1f695a4d3ba7 65862-161 HUMAN PRESCRIPTI
ON DRUG Quinapril Hydrochloride/Hydrochlorothiazide Quinapril Hydroc
hloride/Hydrochlorothiazide "TABLET, FILM COATED" ORAL 20070824
ANDA ANDA078450 Aurobindo Pharma Limited HYDROCHLOROTHIAZIDE; QUI
NAPRIL HYDROCHLORIDE 12.5; 10 mg/1; mg/1 "Increased Diuresis [PE]
,Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting
NAPRIL HYDROCHLORIDE 12.5; 20 mg/1; mg/1 "Angiotensin Converting
Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased
NAPRIL HYDROCHLORIDE 25; 20 mg/1; mg/1 "Angiotensin Converting Enzyme I
nhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis
[PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient]"
65862-164_147eb6a8-f6dc-40d3-bbcf-6af70b0462d1 65862-164 HUMAN PRESCRIPTI
ON DRUG Trandolapril Trandolapril TABLET ORAL 20070612
ANDA ANDA078438 Aurobindo Pharma Limited TRANDOLAPRIL 1
65862-167_4c248c22-c8fa-47a7-9253-d8b68faa713f 65862-167 HUMAN PRESCRIPTI
ON DRUG RISPERIDONE RISPERIDONE SOLUTION ORAL 20090915
ANDA ANDA078452 Aurobindo Pharma Limited RISPERIDONE 1
mg/mL Atypical Antipsychotic [EPC]
65862-168_91cc8489-d129-4ba8-b42c-cb7842d92269 65862-168 HUMAN PRESCRIPTI
ANDA ANDA078512 Aurobindo Pharma Limited ATENOLOL 25
65862-171_861f3444-7a85-42c7-b40d-cc7365526a19 65862-171 HUMAN PRESCRIPTI
65862-175_e43ff522-97ea-475f-9f08-0274c929c238 65862-175 HUMAN PRESCRIPTI
Limited PENICILLIN V POTASSIUM 250 mg/1
65862-176_e43ff522-97ea-475f-9f08-0274c929c238 65862-176 HUMAN PRESCRIPTI
Limited PENICILLIN V POTASSIUM 500 mg/1
65862-177_3c1090af-779c-4fab-85f8-1998997ba579 65862-177 HUMAN PRESCRIPTI
ON DRUG Cefdinir Cefdinir CAPSULE ORAL 20080107
ANDA ANDA065434 Aurobindo Pharma Limited CEFDINIR 300
65862-185_412c6015-45ec-4abb-a43b-6abaf5bc7fc5 65862-185 HUMAN PRESCRIPTI
CAPSULE ORAL 20090826 ANDA ANDA065442 Aurobindo Pharma
Limited CLINDAMYCIN HYDROCHLORIDE 150 mg/1 "Decreased Sebac
Ingredient]"
65862-185_f61aff38-3e81-4521-99ef-44c136f5d494 65862-185 HUMAN PRESCRIPTI
Ingredient]"
65862-186_412c6015-45ec-4abb-a43b-6abaf5bc7fc5 65862-186 HUMAN PRESCRIPTI
Ingredient]"
65862-186_f61aff38-3e81-4521-99ef-44c136f5d494 65862-186 HUMAN PRESCRIPTI
Ingredient]"
65862-187_2ab2cac4-de85-4c39-b996-810de75fe216 65862-187 HUMAN PRESCRIPTI
Aurobindo Pharma Limited ONDANSETRON HYDROCHLORIDE 4 mg/1
65862-190_62700754-4b64-421a-89dd-736867287197 65862-190 HUMAN PRESCRIPTI
Aurobindo Pharma Limited CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1
65862-191_62700754-4b64-421a-89dd-736867287197 65862-191 HUMAN PRESCRIPTI
Aurobindo Pharma Limited CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1
65862-192_ea92a3ed-0c61-4e9a-a89c-4b9aaf3d14fd 65862-192 HUMAN PRESCRIPTI
65862-198_e477a4d3-0aad-41a1-97bf-55bd9261f1db 65862-198 HUMAN PRESCRIPTI
ANDA ANDA078787 Aurobindo Pharma Limited GABAPENTIN 100
65862-201_7bc010bf-be26-48dc-9116-7add024017f6 65862-201 HUMAN PRESCRIPTI
Limited LOSARTAN POTASSIUM 25 mg/1 "Angiotensin 2 Receptor
65862-207_3969972c-82a4-4264-9057-3d1d13e26adf 65862-207 HUMAN PRESCRIPTI
65862-207_f0ee925d-fab9-49dd-8eb0-719ff2887531 65862-207 HUMAN PRESCRIPTI
65862-208_0a3071f9-1136-4e17-92d3-c1e846e522a4 65862-208 HUMAN PRESCRIPTI
ON DRUG Ondansetron Ondansetron Hydrochloride SOLUTION
ONDANSETRON HYDROCHLORIDE 4 mg/5mL "Serotonin 3 Receptor Antagonist
s [MoA],Serotonin-3 Receptor Antagonist [EPC]"
65862-209_f7328957-92f7-4b49-a27a-c69139157a3c 65862-209 HUMAN PRESCRIPTI
Limited MINOCYCLINE HYDROCHLORIDE 50 mg/1 "Tetracycline-cl
65862-214_48947821-208a-47de-a5f7-1b26020da043 65862-214 HUMAN PRESCRIPTI
ANDA ANDA078829 Aurobindo Pharma Limited ZALEPLON 5
65862-215_48947821-208a-47de-a5f7-1b26020da043 65862-215 HUMAN PRESCRIPTI
ANDA ANDA078829 Aurobindo Pharma Limited ZALEPLON 10
65862-218_2e9ad045-7eaa-49a7-ac63-cdc0f87549be 65862-218 HUMAN PRESCRIPTI
CEFDINIR 125 mg/5mL "Cephalosporin Antibacterial [EPC],Cephalosporin
65862-219_2e9ad045-7eaa-49a7-ac63-cdc0f87549be 65862-219 HUMAN PRESCRIPTI
CEFDINIR 250 mg/5mL "Cephalosporin Antibacterial [EPC],Cephalosporin
65862-224_c5ad4b21-17fd-4cb3-b2ec-378142661ec7 65862-224 HUMAN PRESCRIPTI
"SOLUTION, CONCENTRATE" ORAL 20081031 ANDA ANDA078861
Aurobindo Pharma Limited SERTRALINE HYDROCHLORIDE 20 mg/mL
65862-225_0333bbc9-190e-4e2c-adc5-1cbd0fddd1e2 65862-225 HUMAN PRESCRIPTI
65862-226_0333bbc9-190e-4e2c-adc5-1cbd0fddd1e2 65862-226 HUMAN PRESCRIPTI
65862-227_d5352e3f-7a8d-4884-a612-d1becf65b89a 65862-227 HUMAN PRESCRIPTI
ANDA ANDA078956 Aurobindo Pharma Limited LAMOTRIGINE 25
65862-245_deb10f4a-2288-4110-8d75-b57e74fe3f29 65862-245 HUMAN PRESCRIPTI
65862-248_9e63b926-d23c-49ef-9bcc-1a70a68e4d44 65862-248 HUMAN PRESCRIPTI
ON DRUG Escitalopram Oxalate Escitalopram Oxalate SOLUTION
ESCITALOPRAM OXALATE 5 mg/5mL "Serotonin Reuptake Inhibitor [EPC],Sero
65862-249_32757cd4-51bf-4c3f-8af1-810a28555de5 65862-249 HUMAN PRESCRIPTI
ON DRUG Alfuzosin Hydrochloride Alfuzosin Hydrochloride "TABLET, FILM CO
Aurobindo Pharma Limited ALFUZOSIN HYDROCHLORIDE 10 mg/1 "Adrener
gic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]"
65862-250_6895cbc3-b3ea-4b6f-ab06-83f2cb2fde24 65862-250 HUMAN PRESCRIPTI
ANDA ANDA079063 Aurobindo Pharma Limited LEVETIRACETAM 100
65862-286_5fa4a497-7996-4c99-8220-11b17d2f4fc4 65862-286 HUMAN PRESCRIPTI
ON DRUG Perindopril Erbumine Perindopril Erbumine TABLET ORAL
PERINDOPRIL ERBUMINE 2 mg/1 "Angiotensin Converting Enzyme Inhibitor
[EPC],Angiotensin-converting Enzyme Inhibitors [MoA]"
65862-286_d9033965-7cf5-41ef-9efa-d2eec745b43d 65862-286 HUMAN PRESCRIPTI
65862-290_1a576ac9-28f3-44ef-aa51-e7068429891d 65862-290 HUMAN PRESCRIPTI
ANDA ANDA079117 Aurobindo Pharma Limited RIBAVIRIN 200
C]"
65862-290_553bf5c0-4cea-4eed-967b-564d79b11817 65862-290 HUMAN PRESCRIPTI
ANDA ANDA079117 Aurobindo Pharma Limited RIBAVIRIN 200
C]"
65862-291_09d7c48d-23e6-4394-8d27-3bf9cab5b887 65862-291 HUMAN PRESCRIPTI
D RELEASE" ORAL 20120720 ANDA ANDA079118 Aurobind
o Pharma Limited METFORMIN HYDROCHLORIDE 500 mg/1 "Biguanide [EPC]
65862-292_09d7c48d-23e6-4394-8d27-3bf9cab5b887 65862-292 HUMAN PRESCRIPTI
o Pharma Limited METFORMIN HYDROCHLORIDE 750 mg/1 "Biguanide [EPC]
65862-299_5ab40be3-6735-4f5d-af28-9920efa78b85 65862-299 HUMAN PRESCRIPTI
ON DRUG Fluconazole Fluconazole "POWDER, FOR SUSPENSION"
FLUCONAZOLE 10 mg/mL "Azole Antifungal [EPC],Azoles [Chemical/Ingredi
ent],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],
Cytochrome P450 2C9 Inhibitors [MoA]"
65862-300_5ab40be3-6735-4f5d-af28-9920efa78b85 65862-300 HUMAN PRESCRIPTI
ON DRUG Fluconazole Fluconazole "POWDER, FOR SUSPENSION"
FLUCONAZOLE 40 mg/mL "Azole Antifungal [EPC],Azoles [Chemical/Ingredi
ent],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],
Cytochrome P450 2C9 Inhibitors [MoA]"
65862-306_6c0e143a-bb4f-47d9-90c6-a86a1eee1c3b 65862-306 HUMAN PRESCRIPTI
ON DRUG Fluoxetine Fluoxetine SOLUTION ORAL 20090319
ANDA ANDA079209 Aurobindo Pharma Limited FLUOXETINE HYDROCHLORIDE
20 mg/5mL "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors
[MoA]"
65862-308_6a77c6bd-7369-460e-b9cf-ad920eddd2b2 65862-308 HUMAN PRESCRIPTI
ON DRUG Fosinopril Sodium and Hydrochlorothiazide Fosinopril Sodiu
m and Hydrochlorothiazide TABLET ORAL 20090709 ANDA
ANDA079245 Aurobindo Pharma Limited FOSINOPRIL SODIUM; HYDROCHLOROTH
IAZIDE 10; 12.5 mg/1; mg/1 "Angiotensin Converting Enzyme Inhibitor
65862-309_6a77c6bd-7369-460e-b9cf-ad920eddd2b2 65862-309 HUMAN PRESCRIPTI
ON DRUG Fosinopril Sodium and Hydrochlorothiazide Fosinopril Sodiu
m and Hydrochlorothiazide TABLET ORAL 20090709 ANDA
ANDA079245 Aurobindo Pharma Limited FOSINOPRIL SODIUM; HYDROCHLOROTH
IAZIDE 20; 12.5 mg/1; mg/1 "Angiotensin Converting Enzyme Inhibitor
65862-310_d065d7cf-bc3e-4c46-b63c-2544c8d25b6d 65862-310 HUMAN PRESCRIPTI
ON DRUG Didanosine Didanosine "CAPSULE, DELAYED RELEASE"
DIDANOSINE 125 mg/1 "Human Immunodeficiency Virus Nucleoside Analog
65862-325_ba6ba944-03d3-4ec0-9c6e-15a04044ea40 65862-325 HUMAN PRESCRIPTI
Limited DONEPEZIL HYDROCHLORIDE 5 mg/1 "Cholinesterase Inhibito
65862-326_ba6ba944-03d3-4ec0-9c6e-15a04044ea40 65862-326 HUMAN PRESCRIPTI
Limited DONEPEZIL HYDROCHLORIDE 10 mg/1 "Cholinesterase Inhibito
65862-327_2a2c0447-204a-4311-b8cd-c015bac68991 65862-327 HUMAN PRESCRIPTI
emical/Ingredient]"
emical/Ingredient]"
emical/Ingredient]"
65862-357_4e0cdccd-d566-4f86-8f15-3d885b0a5150 65862-357 HUMAN PRESCRIPTI
65862-361_561488a2-779a-49ef-97d3-12f00e319109 65862-361 HUMAN PRESCRIPTI
ON DRUG Lamotrigine Lamotrigine "TABLET, CHEWABLE" ORAL
65862-362_561488a2-779a-49ef-97d3-12f00e319109 65862-362 HUMAN PRESCRIPTI
ON DRUG Lamotrigine Lamotrigine "TABLET, CHEWABLE" ORAL
65862-373_19925447-0a11-455a-b64c-2073d4d88632 65862-373 HUMAN PRESCRIPTI
65862-390_c9b97c1d-d3c6-4f94-9bb8-80797178eba6 65862-390 HUMAN PRESCRIPTI
ONDANSETRON 4 mg/1 "Serotonin 3 Receptor Antagonists [MoA],Serotoni
65862-391_c9b97c1d-d3c6-4f94-9bb8-80797178eba6 65862-391 HUMAN PRESCRIPTI
ONDANSETRON 8 mg/1 "Serotonin 3 Receptor Antagonists [MoA],Serotoni
65862-401_e841d7da-cf85-4361-8227-a00fa7930298 65862-401 HUMAN PRESCRIPTI
RELEASE" ORAL 20110421 ANDA ANDA090554 Aurobind
o Pharma Limited DIVALPROEX SODIUM 125 mg/1 "Anti-epileptic
65862-404_b0e948d7-043f-4f5a-ada0-588a7c0c5515 65862-404 HUMAN PRESCRIPTI
ON DRUG venlafaxine venlafaxine hydrochloride TABLET ORAL
VENLAFAXINE HYDROCHLORIDE 25 mg/1 "Norepinephrine Uptake Inhibitor
nhibitors [MoA]"
VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 "Norepinephrine Uptake Inhibitor
nhibitors [MoA]"
nhibitors [MoA]"
nhibitors [MoA]"
nhibitors [MoA]"
65862-419_1183c243-7184-4bf9-bda2-a276af5f1439 65862-419 HUMAN PRESCRIPTI
Aurobindo Pharma Limited SULFAMETHOXAZOLE; TRIMETHOPRIM 400; 80 mg/1; mg
65862-419_e90faa5a-408f-424d-afed-3e18a2444386 65862-419 HUMAN PRESCRIPTI
Aurobindo Pharma Limited SULFAMETHOXAZOLE; TRIMETHOPRIM 400; 80 mg/1; mg
65862-420_1183c243-7184-4bf9-bda2-a276af5f1439 65862-420 HUMAN PRESCRIPTI
Aurobindo Pharma Limited SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160
65862-420_e90faa5a-408f-424d-afed-3e18a2444386 65862-420 HUMAN PRESCRIPTI
Aurobindo Pharma Limited SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160
65862-422_7c93cda5-d5c5-45af-b5cd-cdb63870808a 65862-422 HUMAN OTC DRUG
Childrens Cetirizine Hydrochloride Allergy Cetirizine Hydrochloride
SOLUTION ORAL 20100202 ANDA ANDA090750 Aurobind
o Pharma Limited CETIRIZINE HYDROCHLORIDE 1 mg/mL
65862-431_b4cf6038-8de3-4b46-9b9f-1c6ec445bd20 65862-431 HUMAN PRESCRIPTI
ON DRUG Ranitidine Ranitidine Hydrochloride SYRUP ORAL
RANITIDINE HYDROCHLORIDE 15 mg/mL "Histamine H2 Receptor Antagonis
65862-443_2474de7e-aff1-473e-9adf-8ec07b5a3dc1 65862-443 HUMAN OTC DRUG
Childrens Cetirizine Hydrochloride Hives Relief Cetirizine Hydrochloride
SOLUTION ORAL 20100202 ANDA ANDA090750 Aurobind
o Pharma Limited CETIRIZINE HYDROCHLORIDE 1 mg/mL
65862-448_b116863c-75b3-45d5-8013-a28211c799bd 65862-448 HUMAN PRESCRIPTI
Aurobindo Pharma Limited VALACYCLOVIR HYDROCHLORIDE 500 mg/1
65862-449_b116863c-75b3-45d5-8013-a28211c799bd 65862-449 HUMAN PRESCRIPTI
Aurobindo Pharma Limited VALACYCLOVIR HYDROCHLORIDE 1 g/1
65862-450_27e07888-54d5-4696-88ce-11f60a2a55ab 65862-450 HUMAN PRESCRIPTI
ON DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride
SYRUP ORAL 20091216 ANDA ANDA090751 Aurobindo Pharma
Limited CETIRIZINE HYDROCHLORIDE 1 mg/mL "Histamine H1 Re
65862-451_339493b1-b80d-453a-bd2c-c4541d55ee18 65862-451 HUMAN PRESCRIPTI
ON DRUG Duloxetine Duloxetine Hydrochloride "CAPSULE, DELAYE
o Pharma Limited DULOXETINE HYDROCHLORIDE 20 mg/1 "Norepin
65862-454_0cd591b0-4ed1-44db-870e-4294ac984041 65862-454 HUMAN PRESCRIPTI
Ingredient]" CIV
Ingredient]" CIV
Ingredient]" CIV
Ingredient]" CIV
65862-458_89845ba2-d240-4915-ad21-d3259ab81eca 65862-458 HUMAN PRESCRIPTI
65862-465_540df288-bae8-462c-a8e5-950092d3ec69 65862-465 HUMAN PRESCRIPTI
ON DRUG Famciclovir Famciclovir "TABLET, FILM COATED" ORAL
FAMCICLOVIR 125 mg/1 "DNA Polymerase Inhibitors [MoA],Herpesvirus Nuc
leoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingred
ient]"
ient]"
ient]"
65862-468_0fdb3977-0c23-4a70-8e7e-ea4de94a2080 65862-468 HUMAN PRESCRIPTI
ANDA ANDA091629 Aurobindo Pharma Limited HYDROCHLOROTHIAZIDE; LOS
ARTAN POTASSIUM 25; 100 mg/1; mg/1 "Angiotensin 2 Receptor Antagonists [MoA
],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic
65862-471_b1c86ca7-9169-43a3-b167-214bb5306f29 65862-471 HUMAN PRESCRIPTI
FOSINOPRIL SODIUM 10 mg/1 "Angiotensin Converting Enzyme Inhibitor
65862-474_93e51728-9b2a-40cd-a559-0f401bb4895c 65862-474 HUMAN PRESCRIPTI
ANDA ANDA091604 Aurobindo Pharma Limited RAMIPRIL 1.25
ANDA ANDA091604 Aurobindo Pharma Limited RAMIPRIL 2.5
ANDA ANDA091604 Aurobindo Pharma Limited RAMIPRIL 5
ANDA ANDA091604 Aurobindo Pharma Limited RAMIPRIL 10
65862-489_a423e921-4280-45dc-be41-a0d65909b1e1 65862-489 HUMAN PRESCRIPTI
ON DRUG Quetiapine Fumarate Quetiapine Fumarate "TABLET, FILM CO
Limited QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [
EPC]
EPC]
EPC]
EPC]
EPC]
EPC]
EPC]
65862-496_87582e1f-4f11-42d5-930f-48f4ddd216a3 65862-496 HUMAN PRESCRIPTI
methoprim SUSPENSION ORAL 20100608 ANDA ANDA0913
48 Aurobindo Pharma Limited SULFAMETHOXAZOLE; TRIMETHOPRIM 200; 40
mg/5mL; mg/5mL "Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredie
65862-501_60800334-a01c-455c-ba18-829315315244 65862-501 HUMAN PRESCRIPTI
ANDA091569 Aurobindo Pharma Limited AMOXICILLIN; CLAVULANATE POTASSI
hibitors [MoA]"
hibitors [MoA]"
hibitors [MoA]"
65862-512_0a0e8c4c-772e-41fd-98ae-c1c220c3c1cb 65862-512 HUMAN PRESCRIPTI
TABLET ORAL 20130213 ANDA ANDA200268 Aurobindo Pharma
Limited PIOGLITAZONE HYDROCHLORIDE 15 mg/1 "Peroxisome Prol
65862-515_d0071aa7-19ea-49f9-a565-03be60ef9f28 65862-515 HUMAN PRESCRIPTI
ON DRUG Naproxen Sodium Naproxen Sodium "TABLET, FILM COATED" ORAL
NAPROXEN SODIUM 275 mg/1 "Cyclooxygenase Inhibitors [MoA],Nonsteroidal An
rug [EPC]"
65862-516_d0071aa7-19ea-49f9-a565-03be60ef9f28 65862-516 HUMAN PRESCRIPTI
ON DRUG Naproxen Sodium Naproxen Sodium "TABLET, FILM COATED" ORAL
NAPROXEN SODIUM 550 mg/1 "Cyclooxygenase Inhibitors [MoA],Nonsteroidal An
rug [EPC]"
65862-520_09b30856-5eb2-4a58-8fe9-e2487e4db5c3 65862-520 HUMAN PRESCRIPTI
ANDA ANDA200429 Aurobindo Pharma Limited NAPROXEN 250
65862-523_03881008-ab0e-41dd-bca7-3d8ca2210a21 65862-523 HUMAN PRESCRIPTI
65862-524_03881008-ab0e-41dd-bca7-3d8ca2210a21 65862-524 HUMAN PRESCRIPTI
65862-525_7612f684-318c-4f32-afbc-259586ff261f 65862-525 HUMAN PRESCRIPTI
ON DRUG Pioglitazone Hydrochloride and Metformin Hydrochloride Pioglita
zone Hydrochloride and Metformin Hydrochloride "TABLET, FILM COATED" ORAL
METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE 500; 15 mg/1; mg/1
inedione [EPC],Thiazolidinediones [Chemical/Ingredient],Biguanide [EPC],Biguanid
65862-526_7612f684-318c-4f32-afbc-259586ff261f 65862-526 HUMAN PRESCRIPTI
ON DRUG Pioglitazone Hydrochloride and Metformin Hydrochloride Pioglita
zone Hydrochloride and Metformin Hydrochloride "TABLET, FILM COATED" ORAL
METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE 850; 15 mg/1; mg/1
inedione [EPC],Thiazolidinediones [Chemical/Ingredient],Biguanide [EPC],Biguanid
65862-527_4cda48b7-bd17-4220-939e-4ef5c2b5ad1c 65862-527 HUMAN PRESCRIPTI
34 Aurobindo Pharma Limited VENLAFAXINE HYDROCHLORIDE 37.5
34 Aurobindo Pharma Limited VENLAFAXINE HYDROCHLORIDE 75
65862-533_9660a38f-66b4-4288-8ba9-ba903e5ff97c 65862-533 HUMAN PRESCRIPTI
ANDA ANDA201090 Aurobindo Pharma Limited AMOXICILLIN; CLAVULANATE
65862-534_9660a38f-66b4-4288-8ba9-ba903e5ff97c 65862-534 HUMAN PRESCRIPTI
hibitors [MoA]"
65862-535_d8f3701a-e494-4671-8077-436241a6c31c 65862-535 HUMAN PRESCRIPTI
65862-536_9aad5ace-c0ba-4a68-a3a4-399c9e633bfd 65862-536 HUMAN PRESCRIPTI
65862-547_176fee98-888a-4059-bcd7-dcd18b318566 65862-547 HUMAN PRESCRIPTI
ON DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlor
ANDA202519 Aurobindo Pharma Limited HYDROCHLOROTHIAZIDE; VALSARTAN
65862-552_4fc69d11-eba7-43eb-86aa-474e86930217 65862-552 HUMAN PRESCRIPTI
65862-553_4fc69d11-eba7-43eb-86aa-474e86930217 65862-553 HUMAN PRESCRIPTI
65862-554_7902fe40-154c-45f3-ae2b-f5fe7f02e267 65862-554 HUMAN PRESCRIPTI
ANDA202261 Aurobindo Pharma Limited MINOCYCLINE HYDROCHLORIDE
45 mg/1 "Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredien
t]"
t]"
t]"
65862-559_2fb32ea7-852b-498f-a412-d1e7a146b655 65862-559 HUMAN PRESCRIPTI
o Pharma Limited PANTOPRAZOLE SODIUM 20 mg/1 "Proton Pump Inh
65862-560_2fb32ea7-852b-498f-a412-d1e7a146b655 65862-560 HUMAN PRESCRIPTI
o Pharma Limited PANTOPRAZOLE SODIUM 40 mg/1 "Proton Pump Inh
65862-561_2737c30d-f7be-42e7-a40f-86c94af8825d 65862-561 HUMAN PRESCRIPTI
ON DRUG Olanzapine Olanzapine TABLET ORAL 20120423
ANDA ANDA202050 Aurobindo Pharma Limited OLANZAPINE 2.5
ANDA ANDA202050 Aurobindo Pharma Limited OLANZAPINE 5
ANDA ANDA202050 Aurobindo Pharma Limited OLANZAPINE 7.5
65862-567_21680fbc-e356-4a05-936b-14b39c3c555a 65862-567 HUMAN PRESCRIPTI
E" ORAL 20120803 ANDA ANDA202096 Aurobindo Pharma
Limited MONTELUKAST SODIUM 4 mg/1 "Leukotriene Receptor An
65862-568_21680fbc-e356-4a05-936b-14b39c3c555a 65862-568 HUMAN PRESCRIPTI
E" ORAL 20120803 ANDA ANDA202096 Aurobindo Pharma
65862-574_704c332a-264d-4ae8-b650-efa50eb03803 65862-574 HUMAN PRESCRIPTI
65862-579_9f57c6f6-4450-4c57-abac-1f35776cd8cf 65862-579 HUMAN PRESCRIPTI
ANDA ANDA202759 Aurobindo Pharma Limited GLIMEPIRIDE 1
65862-582_fa5b1054-846d-45be-b727-e9b8263ad2aa 65862-582 HUMAN PRESCRIPTI
ON DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepri
l Hydrochloride CAPSULE ORAL 20120905 ANDA ANDA202239
Aurobindo Pharma Limited AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
2.5; 10 mg/1; mg/1 "Calcium Channel Antagonists [MoA],Dihydropyridine Calci
65862-594_4f4d91a3-166a-46bc-afa6-f8788e96da2f 65862-594 HUMAN PRESCRIPTI
ON DRUG Divalproex sodium Divalproex sodium "TABLET, FILM CO
Aurobindo Pharma Limited DIVALPROEX SODIUM 250 mg/1 "Anti-ep
65862-595_4f4d91a3-166a-46bc-afa6-f8788e96da2f 65862-595 HUMAN PRESCRIPTI
ON DRUG Divalproex sodium Divalproex sodium "TABLET, FILM CO
Aurobindo Pharma Limited DIVALPROEX SODIUM 500 mg/1 "Anti-ep
65862-596_ddb57a16-8ba1-4ce3-9924-d83e93716daf 65862-596 HUMAN PRESCRIPTI
ON DRUG Clindamycin Palmitate Hydrochloride (Pediatric) Clindamycin Palm
itate Hydrochloride (Pediatric) SOLUTION ORAL 20130430
ANDA ANDA202409 Aurobindo Pharma Limited CLINDAMYCIN PALMITATE HY
DROCHLORIDE 75 mg/5mL "Decreased Sebaceous Gland Activity [PE],Lincosa
65862-597_1a123145-2d63-484a-a0a0-061890796137 65862-597 HUMAN PRESCRIPTI
Aurobindo Pharma Limited LAMIVUDINE; ZIDOVUDINE 150; 300 mg/1; mg
/1 "Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EP
C],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibito
r [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase
Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcr
iptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Revers
e Transcriptase Inhibitors [MoA]"
65862-598_26bb5013-4be1-4809-a516-759014a75816 65862-598 HUMAN PRESCRIPTI
Limited TAMSULOSIN HYDROCHLORIDE 0.4 mg/1 "Adrenergic alph
65862-599_d721ceaf-782a-43d7-a5f2-9e827bcfd554 65862-599 HUMAN PRESCRIPTI
RIZATRIPTAN BENZOATE 5 mg/1 "Serotonin 1b Receptor Agonists [MoA],Se
t [EPC]"
65862-600_d721ceaf-782a-43d7-a5f2-9e827bcfd554 65862-600 HUMAN PRESCRIPTI
RIZATRIPTAN BENZOATE 10 mg/1 "Serotonin 1b Receptor Agonists [MoA],Se
t [EPC]"
65862-601_54404a81-d9d8-4f43-a754-6c37179a40e2 65862-601 HUMAN PRESCRIPTI
ANDA ANDA202566 Aurobindo Pharma Limited MODAFINIL 100
65862-602_54404a81-d9d8-4f43-a754-6c37179a40e2 65862-602 HUMAN PRESCRIPTI
ANDA ANDA202566 Aurobindo Pharma Limited MODAFINIL 200
65862-603_d6789c17-4a2f-4519-9060-e3b0dba422f0 65862-603 HUMAN PRESCRIPTI
ON DRUG Moxifloxacin Hydrochloride Moxifloxacin Hydrochloride
Aurobindo Pharma Limited MOXIFLOXACIN HYDROCHLORIDE 400 mg/1
65862-604_603be0f7-0e08-41bf-9c8b-a605cff50653 65862-604 HUMAN PRESCRIPTI
ON DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride
Limited PRAMIPEXOLE DIHYDROCHLORIDE 0.125 mg/1 "Dopamine Agonis
Limited PRAMIPEXOLE DIHYDROCHLORIDE 1 mg/1 "Dopamine Agonis
65862-617_00efb2cd-607c-4b40-88a0-9ab51ec75500 65862-617 HUMAN PRESCRIPTI
ON DRUG Quinapril Quinapril Hydrochloride "TABLET, FILM COATED"
QUINAPRIL HYDROCHLORIDE 5 mg/1 "Angiotensin Converting Enzyme Inhibitor
65862-625_a8e37688-426c-4290-933d-54a34ae86000 65862-625 HUMAN PRESCRIPTI
DISINTEGRATING" ORAL 20130701 ANDA ANDA203062 Aurobind
o Pharma Limited RIZATRIPTAN BENZOATE 5 mg/1 "Serotonin 1b Re
ceptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Sero
tonin-1d Receptor Agonist [EPC]"
65862-626_a8e37688-426c-4290-933d-54a34ae86000 65862-626 HUMAN PRESCRIPTI
DISINTEGRATING" ORAL 20130701 ANDA ANDA203062 Aurobind
o Pharma Limited RIZATRIPTAN BENZOATE 10 mg/1 "Serotonin 1b Re
ceptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Sero
tonin-1d Receptor Agonist [EPC]"
65862-629_542818a0-6e21-4d62-97cd-bcb6295d0cbc 65862-629 HUMAN PRESCRIPTI
ANDA203630 Aurobindo Pharma Limited HYDROCHLOROTHIAZIDE; IRBESARTAN
65862-630_542818a0-6e21-4d62-97cd-bcb6295d0cbc 65862-630 HUMAN PRESCRIPTI
ANDA203630 Aurobindo Pharma Limited HYDROCHLOROTHIAZIDE; IRBESARTAN
65862-637_d8cd85d0-a301-4e78-8ba7-d90b182a53e2 65862-637 HUMAN PRESCRIPTI
ANDA ANDA203081 Aurobindo Pharma Limited IRBESARTAN 75
[EPC]"
[EPC]"
[EPC]"
65862-656_4d768cfe-3b20-4127-95b9-b4151b28afcc 65862-656 HUMAN PRESCRIPTI
65862-667_cc45e7e1-f9d7-4e2d-9e67-5c4b6d31e059 65862-667 HUMAN PRESCRIPTI
ON DRUG Tramadol Hydrochloride Tramadol Hydrochloride "TABLET, FILM CO
Limited TRAMADOL HYDROCHLORIDE 50 mg/1 "Full Opioid Agonists [M
65862-670_68064989-47ea-4ed5-a20e-43c4ef6ec271 65862-670 HUMAN PRESCRIPTI
ON DRUG Repaglinide Repaglinide TABLET ORAL 20140122
ANDA ANDA203820 Aurobindo Pharma Limited REPAGLINIDE 0.5
mg/1 "Glinide [EPC],Potassium Channel Antagonists [MoA]"
ANDA ANDA203820 Aurobindo Pharma Limited REPAGLINIDE 1
ANDA ANDA203820 Aurobindo Pharma Limited REPAGLINIDE 2
65862-673_dd39c559-5c5d-4d3b-9228-c44085e1699f 65862-673 HUMAN PRESCRIPTI
ON DRUG Felodipine Felodipine "TABLET, FILM COATED, EXTENDED R
ELEASE" ORAL 20130117 ANDA ANDA203417 Aurobindo Pharma
Limited FELODIPINE 2.5 mg/1 "Calcium Channel Antagonists [Mo
edient]"
Limited FELODIPINE 5 mg/1 "Calcium Channel Antagonists [Mo
edient]"
Limited FELODIPINE 10 mg/1 "Calcium Channel Antagonists [Mo
edient]"
34 Aurobindo Pharma Limited VENLAFAXINE HYDROCHLORIDE 150
65862-698_faef39e9-d793-4191-a728-310f6fab759d 65862-698 HUMAN PRESCRIPTI
65862-927_36e7894c-fb04-4749-bce5-ff830cfe66fd 65862-927 HUMAN PRESCRIPTI
58602-422_52dc28ac-4059-4b6c-8bbc-22aa479a549a 58602-422 HUMAN OTC DRUG
Childrens Allergy Relief Cetirizine Hydrochloride SOLUTION
ORAL 20100202 ANDA ANDA090750 Aurohealth LLC CETIRIZI
NE HYDROCHLORIDE 1 mg/mL
13107-001_b45a61f0-6179-45fa-929d-7536bd659190 13107-001 HUMAN PRESCRIPTI
20090817 ANDA ANDA076921 Aurolife Pharma LLC MIRTAZAP
INE 7.5 mg/1
INE 30 mg/1
13107-005_2627f188-05c8-44ac-845e-80678a0c2fdd 13107-005 HUMAN PRESCRIPTI
ANDA ANDA077031 Aurolife Pharma LLC CITALOPRAM HYDROBROMIDE 10
13107-011_966d728e-87ca-4491-9411-2ec253eca632 13107-011 HUMAN PRESCRIPTI
TABLET ORAL 20110315 ANDA ANDA077206 Aurolife Pharma
LLC SERTRALINE HYDROCHLORIDE 25 mg/1 "Serotonin Reuptake Inhi
13107-019_bff12de9-d817-434a-83ef-3d0b67e8fa95 13107-019 HUMAN PRESCRIPTI
ANDA201013 Aurolife Pharma LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE
325; 7.5 mg/1; mg/1 "Opioid Agonist [EPC],Opioid Agonists [MoA]"
CIII
INE 15 mg/1
INE 45 mg/1
13107-043_8229f1a8-4217-461a-ab2c-7a883c56f023 13107-043 HUMAN PRESCRIPTI
LLC ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 2.5 mg/1; mg/1
LLC ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 5 mg/1; mg/1 "Full Op
LLC ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 7.5 mg/1; mg/1
LLC ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 10 mg/1; mg/1 "Full Op
13107-050_8a37015f-aa57-4a43-9ff0-2ca5540f357d 13107-050 HUMAN PRESCRIPTI
20091109 ANDA ANDA077691 Aurolife Pharma LLC SIMVASTA
TIN 5 mg/1 "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl
13107-055_5176403a-4709-4fc6-b1a9-72198e35bff5 13107-055 HUMAN PRESCRIPTI
20120712 ANDA ANDA202160 Aurolife Pharma LLC OXYCODON
" CII
" CII
" CII
13107-062_88f1abdc-f53e-4ff9-b4c1-3cfbc2609b79 13107-062 HUMAN PRESCRIPTI
ATED" ORAL 20100917 ANDA ANDA077739 Aurolife Pharma
LLC METOPROLOL TARTRATE 25 mg/1 "Adrenergic beta-Antagonists [Mo
13107-076_c7605785-8db2-41eb-90e2-f12275b7b299 13107-076 HUMAN PRESCRIPTI
20090801 ANDA ANDA077859 Aurolife Pharma LLC CIPROFLO
13107-077_c7605785-8db2-41eb-90e2-f12275b7b299 13107-077 HUMAN PRESCRIPTI
20090801 ANDA ANDA077859 Aurolife Pharma LLC CIPROFLO
13107-119_a8e32e4d-cb0a-491b-acbd-2627068e3a70 13107-119 HUMAN PRESCRIPTI
20091025 ANDA ANDA078269 Aurolife Pharma LLC RISPERID
ONE 0.25 mg/1 Atypical Antipsychotic [EPC]
ONE 0.5 mg/1 Atypical Antipsychotic [EPC]
ONE 1 mg/1 Atypical Antipsychotic [EPC]
13107-142_5581f10c-3a75-486e-9c3f-98c2c4df970d 13107-142 HUMAN PRESCRIPTI
20090323 ANDA ANDA078332 Aurolife Pharma LLC CARVEDIL
OL 3.125 mg/1 "Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Ant
agonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]
,beta-Adrenergic Blocker [EPC]"
OL 25 mg/1 "Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Ant
13107-154_c9d3ed8f-34a4-444f-a3f7-3fa92dc31df2 13107-154 HUMAN PRESCRIPTI
20091203 ANDA ANDA078406 Aurolife Pharma LLC PAROXETI
13107-168_b72f170e-bfa6-463c-9345-31f8a37e43e2 13107-168 HUMAN PRESCRIPTI
ANDA ANDA078512 Aurolife Pharma LLC ATENOLOL 25 mg/1
13107-014_4821ae32-1354-4c4a-9cb7-16b12f84f204 13107-014 HUMAN PRESCRIPTI
ON DRUG Glycopyrrolate Glycopyrrolate TABLET ORAL 20130415
ANDA ANDA202675 "Aurolife Pharma, LLC" GLYCOPYRROLATE 1 mg/1
"Anticholinergic [EPC],Cholinergic Antagonists [MoA]"
13107-035_24163442-dd03-4066-a6ed-eb7e292b700b 13107-035 HUMAN PRESCRIPTI
ON DRUG DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE
TABLET ORAL 20120214 ANDA ANDA202893 "Aurolife Pharma
, LLC" DEXTROAMPHETAMINE SULFATE 5 mg/1 "Central Nervous System
Stimulant [EPC],Central Nervous System Stimulation [PE]" CII
13107-036_24163442-dd03-4066-a6ed-eb7e292b700b 13107-036 HUMAN PRESCRIPTI
ON DRUG DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE
TABLET ORAL 20120214 ANDA ANDA202893 "Aurolife Pharma
, LLC" DEXTROAMPHETAMINE SULFATE 10 mg/1 "Central Nervous System
13107-058_6343a0a6-3b4c-4030-ad47-a96be42ab112 13107-058 HUMAN PRESCRIPTI
e Phosphate TABLET ORAL 20130415 ANDA ANDA202800
"Aurolife Pharma, LLC" ACETAMINOPHEN; CODEINE PHOSPHATE 300; 15 mg/1; mg
13107-068_e6e2fc80-e0ad-485d-a6b1-2a74fd9c18a4 13107-068 HUMAN PRESCRIPTI
ON DRUG "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextro
amphetamine Sulfate and Amphetamine Sulfate" "Dextroamphetamine Sacch
arate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetam
ine Sulfate" TABLET ORAL 20131127 ANDA ANDA202424
"Aurolife Pharma, LLC" AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE;
DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 1.25; 1.25; 1.25; 1.25
mg/1; mg/1; mg/1; mg/1 "Central Nervous System Stimulant [EPC],Central Nervous
System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous S
ystem Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous Sy
stem Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous Sys
tem Stimulation [PE]" CII
75 mg/1; mg/1; mg/1; mg/1 "Central Nervous System Stimulant [EPC],Central
Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central N
ervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Ne
rvous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Ner
vous System Stimulation [PE]" CII
25 mg/1; mg/1; mg/1; mg/1 "Central Nervous System Stimulant [EPC],Central
Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central N
ervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Ne
rvous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Ner
vous System Stimulation [PE]" CII
DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 5; 5; 5; 5 mg/1; mg
/1; mg/1; mg/1 "Central Nervous System Stimulant [EPC],Central Nervous System S
timulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System St
imulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Sti
mulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stim
ulation [PE]" CII
55150-111_65b8afb4-73d9-46bd-8116-dc30e937210b 55150-111 HUMAN PRESCRIPTI
ANDA065499 AuroMedics Pharma LLC AMPICILLIN SODIUM 250 mg/1
"Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient]"
ANDA065499 AuroMedics Pharma LLC AMPICILLIN SODIUM 500 mg/1
ANDA065499 AuroMedics Pharma LLC AMPICILLIN SODIUM 1 g/1
ANDA065499 AuroMedics Pharma LLC AMPICILLIN SODIUM 2 g/1
55150-115_34c77e60-9b81-49fc-9bcf-fb3f1e388d38 55150-115 HUMAN PRESCRIPTI
AuroMedics Pharma LLC AMPICILLIN SODIUM 10 g/100mL "Penicillin-clas
55150-116_2dc5e84d-4272-4dd5-9bac-b59ae0437704 55150-116 HUMAN PRESCRIPTI
ON DRUG Ampicillin and Sulbactam Ampicillin Sodium and Sulbactam
Sodium "INJECTION, POWDER, FOR SOLUTION" INTRAMUSCULAR; INTRAVENOUS
20120210 ANDA ANDA090349 AuroMedics Pharma LLC AMPICILL
IN SODIUM; SULBACTAM SODIUM 1; .5 g/1; g/1 "Penicillin-class Antiba
cterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],
beta Lactamase Inhibitor [EPC]"
55150-117_2dc5e84d-4272-4dd5-9bac-b59ae0437704 55150-117 HUMAN PRESCRIPTI
Sodium "INJECTION, POWDER, FOR SOLUTION" INTRAMUSCULAR; INTRAVENOUS
20120210 ANDA ANDA090349 AuroMedics Pharma LLC AMPICILL
IN SODIUM; SULBACTAM SODIUM 2; 1 g/1; g/1 "Penicillin-class Antiba
cterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],
beta Lactamase Inhibitor [EPC]"
55150-118_cee45810-c747-44d8-8764-9f9f7ee1fda6 55150-118 HUMAN PRESCRIPTI
Sodium "INJECTION, POWDER, FOR SOLUTION" INTRAVENOUS 20120210
ANDA ANDA090339 AuroMedics Pharma LLC AMPICILLIN SODIUM; SULBACTAM SOD
IUM 100; 50 mg/mL; mg/mL "Penicillin-class Antibacterial [EPC],Penicillin
s [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor
[EPC]"
55150-119_966581b3-9151-4700-bbf1-8f63f87748ef 55150-119 HUMAN PRESCRIPTI
ON DRUG Piperacillin and Tazobactam Piperacillin Sodium and Tazobact
am Sodium "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION" INTRAVENOUS
20120123 ANDA ANDA065498 AuroMedics Pharma LLC PIPERACI
LLIN SODIUM; TAZOBACTAM SODIUM 2; .25 g/1; g/1 "Penicillin-class Antiba
cterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],b
eta Lactamase Inhibitors [MoA]"
55150-122_e31685cd-5b05-4c97-a668-e51c6277e47d 55150-122 HUMAN PRESCRIPTI
ON DRUG Nafcillin Nafcillin Sodium "INJECTION, POWDER, FOR
ANDA091613 AuroMedics Pharma LLC NAFCILLIN SODIUM 1 g/4mL
55150-123_e31685cd-5b05-4c97-a668-e51c6277e47d 55150-123 HUMAN PRESCRIPTI
ANDA091613 AuroMedics Pharma LLC NAFCILLIN SODIUM 2 g/8mL
55150-124_1d0773c4-4cb3-4bc3-aa46-029921514108 55150-124 HUMAN PRESCRIPTI
AuroMedics Pharma LLC NAFCILLIN SODIUM 10 g/100mL "Penicillin-clas
55150-125_d2c7d409-e4e4-493b-82a1-d68327cb3232 55150-125 HUMAN PRESCRIPTI
ON DRUG Ondansetron Ondansetron Hydrochloride "INJECTION, SOLU
00 AuroMedics Pharma LLC ONDANSETRON HYDROCHLORIDE 2 mg/mL
55150-126_60db008c-2b50-4ee2-bb29-7744d752ee1d 55150-126 HUMAN PRESCRIPTI
ON DRUG Ondansetron Ondansetron Hydrochloride "INJECTION, SOLU
99 AuroMedics Pharma LLC ONDANSETRON HYDROCHLORIDE 2 mg/mL
55150-127_785edf6a-6f96-42f9-84b9-9b15ddf05de7 55150-127 HUMAN PRESCRIPTI
ON DRUG Oxacillin Oxacillin Sodium "INJECTION, POWDER, FOR
ANDA201539 AuroMedics Pharma LLC OXACILLIN SODIUM 1 g/1
55150-128_785edf6a-6f96-42f9-84b9-9b15ddf05de7 55150-128 HUMAN PRESCRIPTI
ON DRUG Oxacillin Oxacillin Sodium "INJECTION, POWDER, FOR
ANDA201539 AuroMedics Pharma LLC OXACILLIN SODIUM 2 g/1
55150-129_2edb984c-4346-431f-b452-5aa2f1672cb1 55150-129 HUMAN PRESCRIPTI
ON DRUG Oxacillin Oxacillin Sodium "POWDER, FOR SOLUTION"
INTRAVENOUS 20130118 ANDA ANDA201538 AuroMedics Pharm
a LLC OXACILLIN SODIUM 10 g/100mL "Penicillin-class Antibacterial
[EPC],Penicillins [Chemical/Ingredient]"
55150-129_b0a443a8-05d2-44bc-a150-58526b7f05f6 55150-129 HUMAN PRESCRIPTI
ON DRUG Oxacillin Oxacillin Sodium "POWDER, FOR SOLUTION"
INTRAVENOUS 20130118 ANDA ANDA201538 AuroMedics Pharm
a LLC OXACILLIN SODIUM 10 g/100mL "Penicillin-class Antibacterial
[EPC],Penicillins [Chemical/Ingredient]"
55150-154_19bf5ea6-a28e-493f-a933-cf5db51b28c7 55150-154 HUMAN PRESCRIPTI
ON DRUG Acyclovir Sodium Acyclovir Sodium "INJECTION, SOLU
TION" INTRAVENOUS 20131011 ANDA ANDA203701 AuroMedi
cs Pharma LLC ACYCLOVIR SODIUM 500 mg/10mL "DNA Polymerase Inhibito
rs [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],H
erpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus
Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ing
redient]"
55150-154_d3ab226c-677d-4cb7-85cb-1c2e5012f40d 55150-154 HUMAN PRESCRIPTI
redient]"
55150-155_19bf5ea6-a28e-493f-a933-cf5db51b28c7 55150-155 HUMAN PRESCRIPTI
redient]"
55150-155_d3ab226c-677d-4cb7-85cb-1c2e5012f40d 55150-155 HUMAN PRESCRIPTI
redient]"
55150-156_4038a1a3-cb4c-4724-bcbc-e5ffccb43c42 55150-156 HUMAN PRESCRIPTI
ON DRUG Levofloxacin Levofloxacin "INJECTION, SOLUTION, CONCENTRAT
E" INTRAVENOUS 20130124 ANDA ANDA202328 AuroMedi
cs Pharma LLC LEVOFLOXACIN 500 mg/20mL
55150-157_4038a1a3-cb4c-4724-bcbc-e5ffccb43c42 55150-157 HUMAN PRESCRIPTI
ON DRUG Levofloxacin Levofloxacin "INJECTION, SOLUTION, CONCENTRAT
E" INTRAVENOUS 20130124 ANDA ANDA202328 AuroMedi
cs Pharma LLC LEVOFLOXACIN 750 mg/30mL
55150-158_5524cbfd-d6e6-42eb-aaa5-22495e0a86b6 55150-158 HUMAN PRESCRIPTI
ON DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride "INJECTION, SOLU
ANDA ANDA203040 AuroMedics Pharma LLC LIDOCAINE HYDROCHLORIDE 10
55150-161_89701fac-7536-4f16-87fb-f4cc121e74ee 55150-161 HUMAN PRESCRIPTI
55150-167_ffecf450-1f01-4721-8e10-251385852612 55150-167 HUMAN PRESCRIPTI
ON DRUG Bupivacaine Hydrochloride Bupivacaine Hydrochloride
"INJECTION, SOLUTION" EPIDURAL; INFILTRATION; INTRACAUDAL 20131105
ANDA ANDA203895 AuroMedics Pharma LLC BUPIVACAINE HYDROCHLORIDE
2.5 mg/mL "Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local
Anesthesia [PE]"
"INJECTION, SOLUTION" EPIDURAL; INFILTRATION; INTRACAUDAL 20131105
ANDA ANDA203895 AuroMedics Pharma LLC BUPIVACAINE HYDROCHLORIDE
2.5 mg/mL "Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local
Anesthesia [PE]"
"INJECTION, SOLUTION" EPIDURAL; INTRACAUDAL 20131105 ANDA
ANDA203895 AuroMedics Pharma LLC BUPIVACAINE HYDROCHLORIDE 5
mg/mL "Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthe
sia [PE]"
"INJECTION, SOLUTION" EPIDURAL; INTRACAUDAL 20131105 ANDA
ANDA203895 AuroMedics Pharma LLC BUPIVACAINE HYDROCHLORIDE 5
sia [PE]"
"INJECTION, SOLUTION" EPIDURAL; RETROBULBAR 20131105 ANDA
ANDA203895 AuroMedics Pharma LLC BUPIVACAINE HYDROCHLORIDE 7.5
sia [PE]"
"INJECTION, SOLUTION" EPIDURAL; RETROBULBAR 20131105 ANDA
ANDA203895 AuroMedics Pharma LLC BUPIVACAINE HYDROCHLORIDE 7.5
sia [PE]"
55150-173_200f721e-fcbc-4ded-9912-1c729c012838 55150-173 HUMAN PRESCRIPTI
ON DRUG Sumatriptan Sumatriptan "INJECTION, SOLUTION" SUBCUTAN
EOUS 20130423 ANDA ANDA202758 AuroMedics Pharma LLC
SUMATRIPTAN SUCCINATE 6 mg/.5mL "Serotonin 1b Receptor Agonists [MoA],Se
t [EPC]"
55150-178_17c8a956-fbda-46d2-8b34-cd665b8e2830 55150-178 HUMAN PRESCRIPTI
IUM 1; .5 g/1; g/1 "Penicillin-class Antibacterial [EPC],Penicillin
[EPC]"
55150-179_17c8a956-fbda-46d2-8b34-cd665b8e2830 55150-179 HUMAN PRESCRIPTI
IUM 2; 1 g/1; g/1 "Penicillin-class Antibacterial [EPC],Penicillin
[EPC]"
51072-065_9d0eef3a-7be1-48ef-a227-3347be1c0ce7 51072-065 HUMAN OTC DRUG
Pyrantel Pamoate Pyrantel Pamoate SUSPENSION ORAL
20130419 OTC MONOGRAPH FINAL part357B Aurora Pharmaceu
tical LLC PYRANTEL PAMOATE 5 g/100mL
15667-5049_a5157e03-c82f-4ce9-9355-6b1e5c078fe4 15667-5049 HUMAN OTC DRUG
PAIN GOODBYE MEDICATED CREAM MENTHOL 5% CREAM TOPICAL 20111026
OTC MONOGRAPH NOT FINAL part348 Austin Biotechnology Inc MENTHOL 14
g/280g
15667-7396_8c3ae600-4511-4868-a9bd-848f707e7f87 15667-7396 HUMAN OTC DRUG
PAIN GOODBYE AQUEOUS PATCH METHYL SALICYLATE PATCH TOPICAL
20111026 OTC MONOGRAPH NOT FINAL part348 Austin Biotechnology Inc
2-(L-MENTHOXY)ETHANOL; METHYL SALICYLATE 80; 50 mg/1000mg; mg/1000mg
42792-101_ac957b3e-745f-417a-a238-2293951bba9d 42792-101 HUMAN PRESCRIPTI
ON DRUG UREA UREA CREAM TOPICAL 20110309 UNAPPROV
ED DRUG OTHER "AUSTIN PHARMACEUTICALS, LLC" UREA 390 mg/g
42792-102_46f6ee0a-9a31-489a-b4a8-c2e952205a0a 42792-102 HUMAN PRESCRIPTI
ON DRUG "SODIUM SULFACETAMIDE, SULFUR" "SODIUM SULFACETAMIDE, SULFUR"
LOTION TOPICAL 20110430 UNAPPROVED DRUG OTHER "AUSTIN
PHARMACEUTICALS, LLC" SULFACETAMIDE SODIUM; SULFUR 100; 50 mg/g; mg/g
42792-103_352be91e-3177-458e-9994-c02101583574 42792-103 HUMAN PRESCRIPTI
CREAM TOPICAL 20110430 UNAPPROVED DRUG OTHER "AUSTIN
42792-104_6d49816e-7090-4cad-800a-552b1a0c9d80 42792-104 HUMAN PRESCRIPTI
SUSPENSION TOPICAL 20110604 UNAPPROVED DRUG OTHER
"AUSTIN PHARMACEUTICALS, LLC" SULFACETAMIDE SODIUM; SULFUR 100; 50 mg/g; mg
42792-106_9763fa5e-c309-4350-8039-09a99b72488d 42792-106 HUMAN PRESCRIPTI
ON DRUG SODIUM SULFACETAMIDE SULFACETAMIDE SODIUM LIQUID TOPICAL
20110915 UNAPPROVED DRUG OTHER "Austin Pharmaceuticals,
LLC" SULFACETAMIDE SODIUM 100 mg/mL "Sulfonamide Antibacterial [EPC]
42792-107_ef8d1a87-125b-4286-92e8-0b88269db73f 42792-107 HUMAN PRESCRIPTI
LOTION TOPICAL 20110604 UNAPPROVED DRUG OTHER "AUSTIN
42792-108_25c14acb-cf86-4fe9-8209-b8f00950c923 42792-108 HUMAN PRESCRIPTI
ON DRUG UREA UREA GEL TOPICAL 20101126 UNAPPROV
ED DRUG OTHER "AUSTIN PHARMACEUTICALS, LLC" UREA 400 mg/mL
64540-011_fea2f94b-9421-4cf1-90ac-f0cd0bc7b69b 64540-011 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS "Austin Respiratory Equipment,inc" OXYGEN
990 mL/L
64540-001_36578e0f-c14e-478d-b498-fd94b712c2b2 64540-001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS "Austin Respiratory Equipment,inc." OXYGEN
990 mL/L
76261-125_a14210e4-bfeb-461a-b6af-87946ec1cd8f 76261-125 HUMAN OTC DRUG
ASAP Skin Products Moisturising Daily Defense SPF 30 "Octocrylene,Zin
c Oxide, Avobenzone, Ensulizone, Titanium Dioxide" LOTION TOPICAL 20110603
OTC MONOGRAPH NOT FINAL part352 Australian Skin Products pty ltd AVOBENZO
NE; ENSULIZOLE; OCTOCRYLENE; TITANIUM DIOXIDE; ZINC OXIDE 2; 1.5; 6; 1; 2.
75 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
76261-126_56f3b078-ed8d-4b8b-9214-43644b68b2b0 76261-126 HUMAN OTC DRUG
correcting cream Broad Spectrum SPF 15 asap "avobenzone, Octinoxate, Octocry
lene, Oxybenzone, Zinc Oxide" LOTION TOPICAL 20140804 OTC MONO
GRAPH FINAL part352 AUSTRALIAN SKIN PRODUCTS PTY LTD AVOBENZONE; OCTI
NOXATE; OCTOCRYLENE; OXYBENZONE; ZINC OXIDE 3; 4; 2.7; 3; 4.5 g/100mL;
g/100mL; g/100mL; g/100mL; g/100mL
76261-127_76039001-5295-415d-9010-930f5019b7a7 76261-127 HUMAN OTC DRUG
Hydrating Lip Balm SPF 15 sunscreen ASAP "Avobenzone, Homosalate, Octocry
lene, Octisalate" GEL TOPICAL 20140807 OTC MONOGRAPH FI
NAL part352 AUSTRALIAN SKIN PRODUCTS PTY LTD AVOBENZONE; HOMOSALATE;
OCTISALATE; OCTOCRYLENE 3.5; 5; 5; 5 g/100mL; g/100mL; g/100mL; g/100mL
76261-250_73e7910d-2bc1-4a68-8218-1b7994190391 76261-250 HUMAN OTC DRUG
Sheer Tint Moisturizer SPF 15 ASAP Skin Products "Titanium Dioxide, Zinc
Oxide" LOTION TOPICAL 20110602 OTC MONOGRAPH NOT FINAL part352
AUSTRALIAN SKIN PRODUCTS PTY LTD TITANIUM DIOXIDE; ZINC OXIDE 4; 1
g/100mL; g/100mL
68604-023_96793af4-13d0-46af-ae70-d7d52c696a53 68604-023 HUMAN OTC DRUG
Hand Kleen Premium Antibacterial Hand Triclosan SOAP TOPICAL
20130322 OTC MONOGRAPH NOT FINAL part333A "Auto-Chlor Syst
em, LLC" TRICLOSAN 0.3 g/100mL
68604-231_bb2d97f7-e71c-4cde-8ee0-85c13a6a23ed 68604-231 HUMAN OTC DRUG
Hand Kleen Foaming Antibacterial Hand Triclosan LIQUID TOPICAL
20121217 OTC MONOGRAPH NOT FINAL part333A "Auto-Chlor Syst
em, LLC" TRICLOSAN 0.3 g/100mL
68604-235_65ccf237-a4a5-401b-aec9-ed05dc8861fc 68604-235 HUMAN OTC DRUG
Hand Kleen Golden Touch Antibacterial Hand Cleanser Triclosan
"Auto-Chlor System, LLC" TRICLOSAN 0.5 g/100mL
68604-237_a5509979-d2b3-41eb-b16a-c5f6d12e1242 68604-237 HUMAN OTC DRUG
Hand Kleen Foaming Instant Hand Sanitizer Benzethonium Chloride
"Auto-Chlor System, LLC" BENZETHONIUM CHLORIDE 0.2 g/100mL
68604-238_51ad68f1-0d1b-4c1d-9fac-be0531e2361b 68604-238 HUMAN OTC DRUG
Hand Kleen Southern OrchardAntibacterial Han Antibacterial Hand Cleanser
Triclosan SOAP TOPICAL 20140804 OTC MONOGRAPH NOT FINAL
part333A "Auto-Chlor System, LLC" TRICLOSAN 0.3 g/100mL
51514-0221_74f90a1d-d5fa-45c9-9961-e8995888c4e6 51514-0221 HUMAN OTC DRUG
Yes to Carrots Sweet Fig SPF15 Zinc Oxide STICK TOPICAL 20111201
OTC MONOGRAPH NOT FINAL part352 Autumn Harp ZINC OXIDE 6.5 g/100g
51514-0205_5865f784-16c1-46b0-8b1a-7c58d95adaab 51514-0205 HUMAN OTC DRUG
GAP Favorite Lip Balm Juicy Pear SPF 18 Octinoxate and Oxybenzone
STICK TOPICAL 20111116 OTC MONOGRAPH NOT FINAL part352 "Autumn
Harp, Inc" OCTINOXATE; OXYBENZONE 7.5; 6 g/100g; g/100g
51514-0212_fb302cea-25fd-4bc0-95e5-44a331dc7cd4 51514-0212 HUMAN OTC DRUG
GAP Favorite Lip Balm Citrus Splash SPF 18 Octinoxate and Oxybenzone
51514-0213_7a16cb98-bd5b-4440-b3a7-d358ee39adeb 51514-0213 HUMAN OTC DRUG
Gap favorite Lip Balm Strawberry Kiwi Octinoxate and Oxybenzone STICK
TOPICAL 20111117 OTC MONOGRAPH NOT FINAL part352 "Autumn Harp, In
c" OCTINOXATE; OXYBENZONE 7.5; 6 g/100g; g/100g
51514-0214_fc3ac297-caf8-4d57-baab-b6a63b60ca25 51514-0214 HUMAN OTC DRUG
GAP Favorite Lip Balm Creamy Pomegranate SPF 18 Octinoxate and Oxybenzon
e STICK TOPICAL 20111121 OTC MONOGRAPH NOT FINAL part352
"Autumn Harp, Inc" OCTINOXATE; OXYBENZONE 7.5; 6 g/100g; g/100g
51514-0217_ec87de8a-37d4-4074-8538-e721380ee5b4 51514-0217 HUMAN PRESCRIPTI
ON DRUG GAP Favorite Lip Balm Berry Punch SPF 18 Octinoxate and Oxybezone
51514-0218_b8815d31-bc15-4afd-8f86-3f8564eda7d0 51514-0218 HUMAN OTC DRUG
GAP Favorite Lip Balm Pomegranate SPF 18 Octinoxate and Oxybenzone
51514-0219_10173658-2081-4683-a717-7ff8219136fe 51514-0219 HUMAN OTC DRUG
GAP Favorite Lip Balm Tropical Twist SPF 18 Octinoxate and Oxybenzone
51514-0223_bc21e31a-3343-4126-ae58-401327739921 51514-0223 HUMAN OTC DRUG
GAP favorite Lip Balm Green Apple SPF 18 Octinoxate and Oxybenzone
51514-0227_d70f1df9-31eb-49d2-b024-155777946247 51514-0227 HUMAN OTC DRUG
GAP Favorite Lip Balm Apple Pie SPF 18 Octinoxate and Oxybenzone
51514-0320_3a48f672-c3fe-4ade-9549-a7bf7552aeb7 51514-0320 HUMAN OTC DRUG
Yes To Carrots Sweet Fig Lip Butter with SPF 15 Zinc Oxide STICK
TOPICAL 20130201 OTC MONOGRAPH FINAL part352 "Autumn Harp, In
c" ZINC OXIDE 7.6 g/100g
51514-0324_6e4cd232-2f23-4b65-9158-70e358035e3a 51514-0324 HUMAN OTC DRUG
YES TO GRAPEFRUIT CC CREAM - LIGHT/MEDIUM "Zinc Oxide, Titanium Di
oxide" CREAM TOPICAL 20130619 OTC MONOGRAPH FINAL part352
"Autumn Harp, Inc" TITANIUM DIOXIDE; ZINC OXIDE 2.9; 3.2 mg/100mL
; mg/100mL
51514-0325_6948797b-f5c7-4376-942d-913e9ff5a477 51514-0325 HUMAN OTC DRUG
YES TO GRAPEFRUIT CC CREAM - LIGHT "Zinc Oxide, Titanium Dioxide"
CREAM TOPICAL 20130415 OTC MONOGRAPH FINAL part352 "Autumn
Harp, Inc" TITANIUM DIOXIDE; ZINC OXIDE 2.9; 3.2 mg/100mL; mg/100
mL
51514-0326_14a16b35-c86b-4368-806e-bc38c973c94a 51514-0326 HUMAN OTC DRUG
YES TO CARROTS FRAGRANCE-FREE DAILY FACIAL MOISTURIZER SPF15 "Zinc Ox
ide, Titanium Dioxide" CREAM TOPICAL 20130613 OTC MONOGRAPH FI
NAL part352 "Autumn Harp, Inc" TITANIUM DIOXIDE; ZINC OXIDE 2.9; 3.2
mg/100mL; mg/100mL
51514-0215_c679096d-25ca-4381-aed0-111701137af7 51514-0215 HUMAN OTC DRUG
Gap Favorite Lip Balm Vanilla Mint SPF Octinoxate and Oxybenzone
Harp, Inc." OCTINOXATE; OXYBENZONE 7.5; 6 g/100g; g/100g
51514-0220_ee4cf10e-c704-4ab0-a724-78979568dd79 51514-0220 HUMAN OTC DRUG
GAP Favorite Lip Balm Watermelon SPF Octinoxate and Oxybenzone STICK
c." OCTINOXATE; OXYBENZONE 7.5; 6 g/100g; g/100g
51514-0232_554465a5-6c15-4421-8ecd-66c374dbaadd 51514-0232 HUMAN OTC DRUG
Badger SunScreen Broad Spectrum SPF 16 Zinc Oxide LOTION TOPICAL
20120215 OTC MONOGRAPH NOT FINAL part352 "Autumn Harp, Inc."
ZINC OXIDE 10.6 mL/100mL
51514-0233_39d7e851-a80f-4318-84a0-2b21b336be3f 51514-0233 HUMAN OTC DRUG
Badger Aloe Vera Sunscreen Broad Spectrum SPF 27 Zinc Oxide and Titanium
Dioxide LOTION TOPICAL 20120216 OTC MONOGRAPH NOT FINAL part352
"Autumn Harp, Inc." TITANIUM; ZINC OXIDE 1.75; 87 mL/100mL; mL/100
mL
51514-0235_e1218602-18ec-4010-acd9-658608a55d11 51514-0235 HUMAN OTC DRUG
Babyganics SPF 50 "Octinoxate, Octisalate, and Zinc" SPRAY TOPICAL
20120223 OTC MONOGRAPH NOT FINAL part352 "Autumn Harp, Inc."
OCTINOXATE; OCTISALATE; ZINC OXIDE 7.5; 5; 11.2 mL/100mL; mL/100mL; mL/1
00mL
51514-0236_fadc97b3-9d98-49ca-8151-4d4a1784843a 51514-0236 HUMAN OTC DRUG
Desert Essence Mineral Sunscreen SPF 35 Zinc Oxide CREAM TOPICAL
20130715 OTC MONOGRAPH FINAL part352 "Autumn Harp, Inc."
ZINC OXIDE 15 g/100g
51514-0251_ae363ee5-a377-41f2-b037-a2e728304e83 51514-0251 HUMAN OTC DRUG
Badger Unscented Broad Spectrum SPF 30 Sunscreen Cream Zinc Oxide
CREAM TOPICAL 20130301 OTC MONOGRAPH FINAL part352 "Autumn
Harp, Inc." ZINC OXIDE 18.75 g/100g
51514-0300_e671e00d-fc26-42ca-9194-9b1acd17f363 51514-0300 HUMAN OTC DRUG
Badger Baby SPF 30 Sunscreen Zinc Oxide LOTION TOPICAL 20130301
OTC MONOGRAPH FINAL part352 "Autumn Harp, Inc." ZINC OXIDE 12
g/100mL
51514-0301_ef657658-c5b5-4110-826b-916e0bf5851b 51514-0301 HUMAN OTC DRUG
Badger SPF 30 Aloe Sunscreen Zinc Oxide LOTION TOPICAL 20130301
g/100mL
51514-0302_b9f3a787-51a0-4ca6-aac1-f9bdb9ca6eba 51514-0302 HUMAN OTC DRUG
Badger Kids SPF 30 Sunscreen Zinc Oxide LOTION TOPICAL 20130301
g/100mL
51514-0303_2bab63e9-ca01-4cf7-af4e-3d2d106f9bb3 51514-0303 HUMAN OTC DRUG
Alba TerraTint Bloom SPF 15 Lip Balm Zinc Oxide STICK TOPICAL
ZINC OXIDE 5.5 g/100g
51514-0304_374b5d5c-2bbb-4106-a804-ff355ab75105 51514-0304 HUMAN OTC DRUG
Alba TerraTint Garnet SPF 15 Lip Balm Zinc Oxide STICK TOPICAL
51514-0305_a1e1d4b4-9e71-4599-b3dd-920938d760d8 51514-0305 HUMAN OTC DRUG
Alba TerraTint Blaze SPF 15 Lip Balm Zinc Oxide STICK TOPICAL
51514-0306_06100db1-4158-4b92-9413-d29cec8dcc13 51514-0306 HUMAN OTC DRUG
Alba Very Emollient Sunscreen Lip Care SPF25 "Octocrylene, Octinoxate
, Octisalate, Zinc Oxide" STICK TOPICAL 20120401 OTC MONO
GRAPH FINAL part352 "Autumn Harp, Inc." OCTINOXATE; OCTISALATE; OCTOCRYL
ENE; ZINC OXIDE 7.5; 1; 10; 3.7 g/100g; g/100g; g/100g; g/100g
51514-0307_8b61ef0a-ae74-4347-8cfd-52da928fb227 51514-0307 HUMAN OTC DRUG
YesTo Pomegranate Lip Butter with SPF 15 Zinc Oxide STICK
c." ZINC OXIDE 7.6 g/100g
51514-0308_39f73c6c-5ae5-4ef4-8baa-07196eaa2561 51514-0308 HUMAN OTC DRUG
Badger SPF 35 Sport Sunscreen Face Stick Zinc Oxide STICK
c." ZINC OXIDE 22.5 g/100g
51514-0309_566991ee-a36d-4623-a9a9-01c9b60c9a5d 51514-0309 HUMAN OTC DRUG
Badger SPF 34 Anti-Bug Sunscreen Zinc Oxide LOTION TOPICAL
ZINC OXIDE 20 g/100mL
51514-0310_5e84f843-040d-435d-906b-33ced02744e7 51514-0310 HUMAN OTC DRUG
Badger SPF 30 Kids Sunscreen Cream Zinc Oxide CREAM TOPICAL
ZINC OXIDE 18.75 g/100mL
51514-0311_eb299638-e743-4ffc-9084-cb02f16dd8d9 51514-0311 HUMAN OTC DRUG
Badger SPF 30 Baby Sunscreen Cream Zinc Oxide CREAM TOPICAL
51514-0312_f53f778a-556d-4961-8805-1dae2b2f6775 51514-0312 HUMAN OTC DRUG
Badger SPF 35 Sport Sunscreen Cream Zinc Oxide CREAM TOPICAL
51514-0313_3c04679a-535c-43b5-933b-304c39cab77e 51514-0313 HUMAN OTC DRUG
Badger Zinc Oxide Diaper Cream Zinc Oxide CREAM TOPICAL 20130318
g/100mL
51514-0314_fbdfb2bc-1d76-4d6e-acdf-c9cb9027558c 51514-0314 HUMAN OTC DRUG
Badger SPF 15 Sunscreen Lip Balm Zinc Oxide STICK TOPICAL
ZINC OXIDE 8 g/100g
51514-0315_8f3e090a-3d0e-479c-ac5b-8a3dd69ecc00 51514-0315 HUMAN OTC DRUG
Yes To Cucumbers Natural Sunscreen SPF 30 Stick "Zinc Oxide, Titanium Di
oxide" STICK TOPICAL 20130111 OTC MONOGRAPH FINAL part352
"Autumn Harp, Inc." TITANIUM DIOXIDE; ZINC OXIDE 4.9; 10.8 g/100g;
g/100g
51514-0316_2d684392-63bd-4cc6-8412-7d12b244680b 51514-0316 HUMAN OTC DRUG
Yes To Cucumbers Natural Sunscreen SPF 40 Kids "Zinc Oxide, Titanium Di
oxide" LOTION TOPICAL 20121230 OTC MONOGRAPH FINAL part352
"Autumn Harp, Inc." TITANIUM DIOXIDE; ZINC OXIDE 5.5; 11.7 g/100mL;
g/100mL
51514-0317_758659ed-1519-4a12-b5ca-b510344486c5 51514-0317 HUMAN OTC DRUG
Yes To Grapefruit Moisturizer with SPF15 "Zinc Oxide, Titanium Di
"Autumn Harp, Inc." TITANIUM DIOXIDE; ZINC OXIDE 2.9; 3.2 mg/100mL
; mg/100mL
51514-0318_d806c4c7-0eaa-47bf-a424-0bdfe08f3a43 51514-0318 HUMAN OTC DRUG
Yes To Cucumbers Natural Sunscreen SPF 30 "Zinc Oxide, Titanium Di
"Autumn Harp, Inc." TITANIUM DIOXIDE; ZINC OXIDE 6.2; 11 g/100g; g/100g
51514-0319_aab342e3-7422-4699-8a16-73191285480b 51514-0319 HUMAN OTC DRUG
Urban Decay Naked Skin Beauty Balm SPF 20 "Octinoxate, Zinc Oxide"
LOTION TOPICAL 20130712 OTC MONOGRAPH FINAL part352 "Autumn
Harp, Inc." OCTINOXATE; ZINC OXIDE 7.5; 3.4 mg/100mL; mg/100mL
51514-0321_01072a9e-6de2-4c1b-ac13-f980994516bd 51514-0321 HUMAN OTC DRUG
Yes To Cucumbers Daily Moisturizer SPF 30 "Zinc Oxide, Titanium Di
"Autumn Harp, Inc." TITANIUM DIOXIDE; ZINC OXIDE 6.2; 11 mg/100mL; mg/100
mL
51514-0322_a27a7f76-5ba8-4258-a9fa-a346075c5cd3 51514-0322 HUMAN OTC DRUG
Yes To Blueberries Daily Repairing Moisturizer SPF30 "Zinc Oxide, Tit
anium Dioxide" LOTION TOPICAL 20130322 OTC MONOGRAPH FINAL
part352 "Autumn Harp, Inc." TITANIUM DIOXIDE; ZINC OXIDE 6.2; 11 mg/100mL
; mg/100mL
51514-0323_94cde319-7aa2-4cbe-804e-6e911c8638f3 51514-0323 HUMAN OTC DRUG
Yes To Carrots Daily Facial Moisturizer SPF 15 "Zinc Oxide, Titanium Di
; mg/100mL
51514-0327_52a0349e-f327-4681-9491-d38cf5ce7776 51514-0327 HUMAN OTC DRUG
YES TO TOMATOES ROLLER BALL SPOT STICK Salicylic Acid SOLUTION
TOPICAL 20110112 OTC MONOGRAPH FINAL part333D "Autumn
Harp, Inc." SALICYLIC ACID 2 mg/100mL
51514-0328_5de6b069-fa7b-42fa-a68e-64b28fa9c07b 51514-0328 HUMAN OTC DRUG
YES TO TOMATOES DAILY PORE SCRUB Salicylic Acid CREAM TOPICAL
20110113 OTC MONOGRAPH FINAL part333D "Autumn Harp, In
c." SALICYLIC ACID 2 g/100g
51514-0329_b2166f8a-0db3-4a61-8827-41d7ea4cac41 51514-0329 HUMAN OTC DRUG
YES TO TOMATOES ACNE CONTROL GEL CLEANSER Salicylic Acid GEL
TOPICAL 20111027 OTC MONOGRAPH FINAL part333D "Autumn
Harp, Inc." SALICYLIC ACID 1 g/100mL
51514-0330_f5e8b855-707e-4624-86e3-c1b85f5e41dd 51514-0330 HUMAN OTC DRUG
Yes To Tomatoes Daily Repair Treatment Salicylic Acid GEL TOPICAL
20130411 OTC MONOGRAPH FINAL part333D "Autumn Harp, In
c." SALICYLIC ACID 1 mg/100mL
51514-0331_6ac92a0a-fcc0-4c05-8bee-d741f46afbb5 51514-0331 HUMAN OTC DRUG
Urban Decay Naked Skin Light Beauty Balm SPF20 "Octinoxate, Zinc Oxide"
51514-0332_ded5c521-cdfa-4c5f-8f84-5fd202204a52 51514-0332 HUMAN OTC DRUG
Josie Maran Argan Daily Moisturizer SPF47 "Zinc Oxide, Titanium Di
; mg/100mL
51514-0333_3be87ace-b30b-4b05-b4d8-fd4aa4f0eb8d 51514-0333 HUMAN OTC DRUG
Urban Decay Naked Skin Dark Beauty Balm SPF20 "Octinoxate, Zinc Oxide"
51514-0336_3153033b-7552-4484-a4db-f403330ef2ee 51514-0336 HUMAN OTC DRUG
LIP CARE SPF 15 WITH VITAMIN E "Octinoxate, Oxybenzone" STICK
c." OCTINOXATE; OXYBENZONE 7.5; 5 g/100g; g/100g
51514-0337_2865f218-0c89-4b93-a811-39bad63cdc67 51514-0337 HUMAN OTC DRUG
Josie Maran Argan Daily Moisturizer SPF47 Protect and Perfect "Zinc Ox
ide, Titanium Dioxide" LOTION TOPICAL 20140305 OTC MONOGRAPH FI
NAL part352 "Autumn Harp, Inc." TITANIUM DIOXIDE; ZINC OXIDE 5.9; 9.4
mg/100mL; mg/100mL
51514-0338_086b6d24-c552-4eb2-a405-ff1be677af5f 51514-0338 HUMAN OTC DRUG
Desert Essence Dont Be Rash Diaper Cream Zinc Oxide CREAM
c." ZINC OXIDE 12 g/100mL
51514-201_06b61907-1137-428b-983c-6b87daf0becb 51514-201 HUMAN OTC DRUG
Badger SPF30 Unscented Sunscreen Unscented Zinc Oxide OINTMENT
c." ZINC OXIDE 18.75 mL/100mL
66887-001_938c29c0-fae8-11e3-a3ac-0800200c9a66 66887-001 HUMAN PRESCRIPTI
ON DRUG Testim testosterone GEL TRANSDERMAL 20021031
NDA NDA021454 "Auxilium Pharmaceuticals, Inc." TESTOSTERONE
50 mg/5g "Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Ch
emical/Ingredient]" CIII
66887-003_655fce70-5d19-11e3-949a-0800200c9a66 66887-003 HUMAN PRESCRIPTI
ON DRUG XIAFLEX collagenase clostridium histolyticum KIT
20100222 BLA BLA125338 "Auxilium Pharmaceuticals, Inc."
51098-742_1d8e5de7-1d23-487a-a5cc-535ac356504d 51098-742 HUMAN OTC DRUG
Hands First 4 in 1 "Benzalkonium Chloride, Allantoin" SOLUTION
TOPICAL 20100801 OTC MONOGRAPH FINAL part347 Avadim II LLC
ALLANTOIN; BENZALKONIUM CHLORIDE 5; 1.3 g/1000mL; mL/1000mL
61594-000_ba10d804-11bd-4e40-b5b4-869b68acd98b 61594-000 HUMAN OTC DRUG
Theraworx pre-moistened cloths ALLANTOIN LIQUID TOPICAL 20140313
OTC MONOGRAPH FINAL part347 "Avadim Technologies, Inc." ALLANTOIN
0.5 g/100g
61594-001_6d9b3b30-342d-4ad1-aa1c-b11431be86e5 61594-001 HUMAN OTC DRUG
Theraworx Patented Foam Formulation ALLANTOIN LIQUID TOPICAL
20140109 OTC MONOGRAPH FINAL part347 "Avadim Technologies, In
c." ALLANTOIN 5 mg/mL
64597-301_227f068c-e569-4bb1-90e6-39196b27ea38 64597-301 HUMAN PRESCRIPTI
ON DRUG NUEDEXTA dextromethorphan hydrobromide and quinidine sulf
ate "CAPSULE, GELATIN COATED" ORAL 20101201 NDA
NDA021879 "Avanir Pharmaceuticals, Inc." DEXTROMETHORPHAN HYDROBROMIDE; Q
UINIDINE SULFATE 20; 10 mg/1; mg/1 "Uncompetitive N-methyl-D-aspart
Antagonists [MoA],Sigma-1 Receptor Agonists [MoA],Antiarrhythmic [EPC],Cytochrom
e P450 2D6 Inhibitor [EPC],Cytochrome P450 2D6 Inhibitors [MoA]"
43493-0001_452914d5-bba7-4497-a230-951c541ce99b 43493-0001 HUMAN OTC DRUG
Pain Relief Rub Iampur "Camphor, Menthol, Methyl Salicylate" CREAM TOPICAL
20130201 OTC MONOGRAPH FINAL part348 Avaria Health & Beauty C
orp CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 4; 4; 11 g/100g;
g/100g; g/100g
43493-0002_26361049-6743-491c-b895-3f931e5b0f10 43493-0002 HUMAN OTC DRUG
Pain Relieving Iampur "Camphor, Menthol, Methyl Salicylate" CREAM TOPICAL
20130524 OTC MONOGRAPH NOT FINAL part348 Avaria Health & Beauty C
orp CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 4; 4; 11 g/g; g/g
; g/g
58518-010_04e26667-d23f-4fad-9fcb-04214015c78c 58518-010 HUMAN OTC DRUG
ENVIRONMENTAL DEFENSE ZINC OXIDE CREAM TOPICAL 20130718
OTC MONOGRAPH NOT FINAL part352 Avasol ZINC OXIDE 225 mg/100mL
58518-020_a3bd6294-10df-4782-a64e-624abf171497 58518-020 HUMAN OTC DRUG
SURFERS BARRIER ZINC OXIDE STICK TOPICAL 20130718
OTC MONOGRAPH NOT FINAL part352 Avasol ZINC OXIDE 24.5 g/100g
57677-059_b9855c21-da7e-4df5-a6a9-974efc254e03 57677-059 HUMAN OTC DRUG
MINERAL TINTED MOISTURE BROAD SPECTRUM SPF 15 OIL FREE TITANIUM DIOXIDE
LOTION TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 AVEDA CO
PORATION TITANIUM DIOXIDE 0.04601 g/mL
57677-005_08b34822-5067-4a70-90ee-337b990e5977 57677-005 HUMAN OTC DRUG
Aveda Active Composition "Menthol, Methyl Salicylate" LIQUID
TOPICAL 20110308 OTC MONOGRAPH FINAL part348 Aveda Corporatio
n MENTHOL; METHYL SALICYLATE 1.25; 12.45 mL/50mL; mL/50mL
57677-057_21172e1e-744d-4a12-82ee-079291e3b55d 57677-057 HUMAN OTC DRUG
MINERAL TINTED MOISTURIZER SPF 15 TITANIUM DIOXIDE LOTION TOPICAL
20031101 OTC MONOGRAPH NOT FINAL part352 Aveda Corporation
63548-0007_5b7902b6-5781-47e0-b574-ad8716cc0e66 63548-0007 HUMAN OTC DRUG
Mucus Relief Guaifenesin TABLET ORAL 20110118
OTC MONOGRAPH FINAL part341 Avema Pharma Solutions GUAIFENESIN 400
mg/1
63548-0046_168ccdca-6ba8-4edc-9c0e-504ae9aa065a 63548-0046 HUMAN OTC DRUG
Aspirin Enteric Safety Coated Aspirin "TABLET, DELAYED RELEASE" ORAL
20110811 OTC MONOGRAPH FINAL part343 Avema Pharma Solutions
ASPIRIN 81 mg/1
63548-0056_627333c2-4233-4a95-bd93-53d1257ef07e 63548-0056 HUMAN OTC DRUG
Stool Softener Plus Stimulant Laxative Docusate sodium and Sennosides
TABLET ORAL 20110518 OTC MONOGRAPH NOT FINAL part334 Avema Ph
arma Solutions DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1
63548-0064_6896cbdd-7377-4305-9bef-8c876ac1bfbd 63548-0064 HUMAN OTC DRUG
Nighttime Sleep Aid Diphenhydramine HCL TABLET ORAL 20110116
OTC MONOGRAPH FINAL part338 Avema Pharma Solutions DIPHENHYDRAMINE HYDROCHL
ORIDE 25 mg/1
63548-0065_89c90659-b059-4b99-bdce-b31d3e78a48c 63548-0065 HUMAN OTC DRUG
Pain Relief PM "Acetaminophen, Diphenhydramine HCl" "TABLET, COATED"
ORAL 20120514 OTC MONOGRAPH NOT FINAL part343 Avema Pharma Sol
utions ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1
63548-0068_55b12994-1ec8-4dba-b37f-d9b385e39773 63548-0068 HUMAN OTC DRUG
Gentle Relief Senna Laxative Sennosides TABLET ORAL 20120430
OTC MONOGRAPH FINAL part334 Avema Pharma Solutions SENNOSIDES A AND B
8.6 mg/1
63548-0069_00978d30-54d2-4131-9bd2-be522c3cf3f4 63548-0069 HUMAN OTC DRUG
Senna-S "DOCUSATE SODIUM, SENNOSIDES" "TABLET, COATED" ORAL
20120430 OTC MONOGRAPH NOT FINAL part334 Avema Pharma Solutions
DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1
63548-0070_64d48a9c-8432-4538-8560-ccd4a10e5345 63548-0070 HUMAN OTC DRUG
Antihistimine Allergy DIPHENHYDRAMINE HYDROCHLORIDE "TABLET, COATED"
ORAL 20120430 OTC MONOGRAPH FINAL part341 Avema Pharma Sol
utions DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1
63548-1278_dccb0b89-87d9-4a27-8b3b-39e8c84e3a3e 63548-1278 HUMAN OTC DRUG
Senna Laxative Sennosides "TABLET, COATED" ORAL 20100102
OTC MONOGRAPH FINAL part341 Avema Pharma Solutions SENNOSIDES 8.6
mg/1
63548-2341_691c5587-3994-45e2-a669-608ba7a98bfb 63548-2341 HUMAN OTC DRUG
Pain Relief PM Acetaminophen and Diphenhydramine Hydrochloride "TABLET,
COATED" ORAL 20100102 UNAPPROVED DRUG OTHER
Avema Pharma Solutions ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25
mg/1; mg/1
63548-3482_f0ef7742-a09e-4d1b-9658-e9c0ba8ee003 63548-3482 HUMAN OTC DRUG
Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride "TABLET,
Avema Pharma Solutions DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1
63548-3602_0ca53eeb-d615-4666-9599-67525d2ddef5 63548-3602 HUMAN OTC DRUG
Asprin Aspirin "TABLET, DELAYED RELEASE" ORAL 20100102
OTC MONOGRAPH FINAL part343 Avema Pharma Solutions ASPIRIN 81 mg/1
63548-3733_8ec52f26-6b58-4b66-8653-614cf055ba80 63548-3733 HUMAN OTC DRUG
Mucus Relief Guaifenesin "TABLET, COATED" ORAL 20100102
UNAPPROVED DRUG OTHER Avema Pharma Solutions GUAIFENESIN 400
mg/1
63548-4000_a3c1cd07-a6ee-44b0-9854-622d8ba2d8f8 63548-4000 HUMAN OTC DRUG
Stool Softener Docusate Sodium and Sennosides "TABLET, COATED"
ORAL 20100102 UNAPPROVED DRUG OTHER Avema Pharma Sol
utions DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1
63548-4001_27ed056c-ec07-4269-9883-1f856c338aca 63548-4001 HUMAN OTC DRUG
Senna-S Docusate Sodium and Sennosides "TABLET, COATED" ORAL
20100102 UNAPPROVED DRUG OTHER Avema Pharma Solutions
DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1
63548-6352_9ea81f82-8fee-4569-8cfc-a102a9747de0 63548-6352 HUMAN OTC DRUG
Mucus Relief DM Dextromethorphan Hydrobromide and Guaifenesin "TABLET,
Avema Pharma Solutions DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400
mg/1; mg/1
63548-6373_058eef84-fdbc-4f27-a619-72e89d535766 63548-6373 HUMAN OTC DRUG
Sleep Easy Diphenhydramine Hydrochloride "TABLET, COATED"
ORAL 20100102 OTC MONOGRAPH FINAL part338 Avema Pharma Sol
utions DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1
42536-6044_35a018ba-f817-4f46-81e2-d8e2a5319d48 42536-6044 HUMAN PRESCRIPTI
ON DRUG PYtest "Urea, C-14" CAPSULE ORAL 19970509
NDA NDA020617 "Avent, Inc." "UREA, C-14" 1 uCi/1
42536-6046_ed333311-0729-4d5e-86d6-1d3dcd72896d 42536-6046 HUMAN PRESCRIPTI
ON DRUG PYtest "Urea, C-14" CAPSULE ORAL 19970509
NDA NDA020617 "Avent, Inc." "UREA, C-14" 1 uCi/1
12516-0592_4057b792-ee8b-46ad-a497-9691e43d362b 12516-0592 HUMAN PRESCRIPTI
ON DRUG ELOXATIN oxaliplatin "INJECTION, SOLUTION, CONCENTRAT
E" INTRAVENOUS 20090722 NDA NDA021759 Aventis
Pharma Ltd. OXALIPLATIN 5 mg/mL "Platinum-based Drug [EPC],Plati
num-containing Compounds [Chemical/Ingredient]"
75854-102_255620a8-957a-44ed-95ef-b0edb01cc543 75854-102 HUMAN PRESCRIPTI
ON DRUG Ana-Lex hydrocortisone acetate and lidocaine hydrochloride
CREAM TOPICAL 20080228 UNAPPROVED DRUG OTHER "Avion P
harmaceuticals, LLC" HYDROCORTISONE ACETATE; LIDOCAINE HYDROCHLORIDE 20; 20
mg/g; mg/g "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [
MoA],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [E
PC],Local Anesthesia [PE]"
75854-301_ae24a5b1-0688-4c76-ac39-770bb5377091 75854-301 HUMAN PRESCRIPTI
ON DRUG Prenate Elite ".beta.-carotene, ascorbic acid, cholecalciferol
, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide
, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium pantothe
nate, calcium carbonate, ferrous fumarate, potassium iodide, magnesium oxide, zi
nc oxide and cupric oxide" "TABLET, COATED" ORAL 20120806
UNAPPROVED DRUG OTHER "Avion Pharmaceuticals, LLC" ".ALPHA.-TOCOPHE
ROL ACETATE, DL-; .BETA.-CAROTENE; ASCORBIC ACID; BIOTIN; CALCIUM CARBONATE; CAL
CIUM PANTOTHENATE; CHOLECALCIFEROL; CUPRIC OXIDE; CYANOCOBALAMIN; FERROUS FUMARA
TE; FOLIC ACID; MAGNESIUM OXIDE; NIACINAMIDE; POTASSIUM IODIDE; PYRIDOXINE HYDRO
CHLORIDE; RIBOFLAVIN; THIAMINE; ZINC OXIDE" 10; 2600; 75; 330; 100; 6; 450;
1.5; 13; 26; 1; 25; 21; 150; 21; 3.5; 3; 15 [iU]/1; [iU]/1; mg/1; ug/1; mg/1
; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1
"Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredie
nt],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Facto
r Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingred
ient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA]"
75854-302_d4ee6ee8-e5c2-464e-b68c-a6510c32a098 75854-302 HUMAN PRESCRIPTI
ON DRUG PRENATE DHA "ascorbic acid, cholecalciferol, .alpha.-tocophe
rol, dl-, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonat
e, ferrous fumarate, magnesium oxide and doconexent" "CAPSULE, GELATIN COATED
" ORAL 20120131 UNAPPROVED DRUG OTHER "Avion P
harmaceuticals, LLC" ".ALPHA.-TOCOPHEROL, DL-; ASCORBIC ACID; CALCIUM CARBONA
TE; CHOLECALCIFEROL; CYANOCOBALAMIN; DOCONEXENT; FERROUS FUMARATE; FOLIC ACID; M
AGNESIUM OXIDE; PYRIDOXINE HYDROCHLORIDE" 10; 90; 145; 220; 13; 300; 28; 1
; 50; 26 [iU]/1; mg/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1
75854-303_09e2b1e8-94fa-4015-9cc4-9e81b605c6c0 75854-303 HUMAN PRESCRIPTI
ON DRUG prenate essential "- ascorbic acid, cholecalciferol, .alph
a.-tocopherol, dl-, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin
, calcium carbonate, ferrous fumarate, potassium iodide, magnesium oxide, docone
xent and icosapent" "TABLET, COATED" ORAL 20121112
ROL, DL-; ASCORBIC ACID; BIOTIN; CALCIUM CARBONATE; CHOLECALCIFEROL; CYANOCOBALA
MIN; DOCONEXENT; FERROUS FUMARATE; FOLIC ACID; ICOSAPENT; MAGNESIUM OXIDE; POTAS
SIUM IODIDE; PYRIDOXINE HYDROCHLORIDE" 10; 90; 280; 145; 220; 13; 300; 29; 1; 4
0; 50; 150; 26 [iU]/1; mg/1; ug/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1;
mg/1; ug/1; mg/1 "Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin
ivalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exch
ange Activity [MoA]"
75854-304_2f878a07-6f89-4ef2-8f53-26d2768155d1 75854-304 HUMAN PRESCRIPTI
ON DRUG prenate mini "ascorbic acid, cholecalciferol, .alpha.-tocophe
rol, dl-, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium
carbonate, iron pentacarbonyl, potassium iodide, magnesium oxide, doconexent and
lowbush blueberry" "CAPSULE, GELATIN COATED" ORAL 20120515
ROL, DL-; ASCORBIC ACID; BIOTIN; CALCIUM CARBONATE; CHOLECALCIFEROL; CYANOCOBALA
MIN; DOCONEXENT; FOLIC ACID; IRON PENTACARBONYL; LOWBUSH BLUEBERRY; MAGNESIUM OX
IDE; POTASSIUM IODIDE; PYRIDOXINE HYDROCHLORIDE" 10; 60; 280; 100; 220; 1
3; 350; 1; 29; 25; 25; 150; 26 [iU]/1; mg/1; ug/1; mg/1; [iU]/1; ug/1; mg/1; mg
/1; mg/1; mg/1; mg/1; ug/1; mg/1 "Vitamin D [Chemical/Ingredient],Vitamin
D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation
Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingred
ient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Ma
gnesium Ion Exchange Activity [MoA]"
75854-305_9412fffa-6a5b-4dde-a0f4-07b6d71280a4 75854-305 HUMAN PRESCRIPTI
ON DRUG FeRiva "ferrous bisglycinate, ascorbic acid, folic acid, cyanoc
obalamin, biotin" CAPSULE ORAL 20121230 UNAPPROVED DRUG
OTHER "Avion Pharmaceuticals, LLC" ASCORBIC ACID; BIOTIN; CYANOCOBA
LAMIN; FERROUS BISGLYCINATE; FOLIC ACID 175; 300; 120; 75; 1 mg/1; ug/1; ug/1
; mg/1; mg/1 "Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC]"
75854-306_46d0309d-b2c8-40ee-a076-063e513ada52 75854-306 HUMAN PRESCRIPTI
ON DRUG Prenate Chewable "calcium carbonate, cholecalciferol, mag
nesium oxide, boron, folic acid, pyridoxine hydrochloride, cyanocobalamin, bioti
n and bilberry" "TABLET, CHEWABLE" ORAL 20130116 UNAPPROV
ED DRUG OTHER "Avion Pharmaceuticals, LLC" BILBERRY; BIOTIN; BORON;
CALCIUM CARBONATE; CHOLECALCIFEROL; CYANOCOBALAMIN; FOLIC ACID; MAGNESIUM OXIDE
; PYRIDOXINE HYDROCHLORIDE 25; 280; 250; 500; 300; 125; 1; 50; 10 mg/1; ug
/1; ug/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1 "Blood Coagulation Factor [EPC],
Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations
, Divalent [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC]
,Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Vitamin B
75854-307_961e9823-88be-44fa-9148-b4704aa3b74e 75854-307 HUMAN PRESCRIPTI
ON DRUG Prenate AM ".pyridoxine hydrochloride, cyanocobalamin, calc
ium carbonate and folic acid" "TABLET, COATED" ORAL 20130615
UNAPPROVED DRUG OTHER "Avion Pharmaceuticals, LLC" CALCIUM CARBONAT
E; CYANOCOBALAMIN; FOLIC ACID; PYRIDOXINE HYDROCHLORIDE 200; 12; 1; 75 mg/1; ug
/1; mg/1; mg/1 "Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coag
ulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemica
l/Ingredient],Cations, Divalent [Chemical/Ingredient]"
75854-308_1076ba9a-0168-492f-ba9b-99fa02186092 75854-308 HUMAN PRESCRIPTI
ON DRUG PRENATE Restore "ascorbic acid, cholecalciferol, .alpha.-tocophe
rol acetate, dl-, folic acid, pyridoxine hydrochloride, cyanocobalamin, biotin,
calcium carbonate, ferrous fumarate, magnesium oxide, lactic acid and doconexent
" "CAPSULE, GELATIN COATED" ORAL 20130917 UNAPPROV
ED DRUG OTHER "Avion Pharmaceuticals, LLC" ".ALPHA.-TOCOPHEROL ACET
ATE, DL-; ASCORBIC ACID; BIOTIN; CALCIUM CARBONATE; CHOLECALCIFEROL; CYANOCOBALA
MIN; DOCONEXENT; FERROUS FUMARATE; FOLIC ACID; LACTIC ACID; MAGNESIUM OXIDE; PYR
IDOXINE HYDROCHLORIDE" 10; 85; 500; 155; 1000; 12; 400; 27; 1; 10; 45; 25
[iU]/1; mg/1; ug/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1
75854-309_cf10de09-6ed5-4a66-84fa-2da4f668bbe6 75854-309 HUMAN PRESCRIPTI
ON DRUG PRENATE Enhance "ascorbic acid, cholecalciferol, .alpha.-tocophe
rol acetate, dl-, folic acid, pyridoxine hydrochloride, cyanocobalamin, biotin,
calcium carbonate, ferrous fumarate, magnesium oxide, lactic acid and doconexent
" "CAPSULE, GELATIN COATED" ORAL 20130917 UNAPPROV
ED DRUG OTHER "Avion Pharmaceuticals, LLC" ".ALPHA.-TOCOPHEROL ACET
ATE, DL-; ASCORBIC ACID; BIOTIN; CALCIUM CARBONATE; CHOLECALCIFEROL; CYANOCOBALA
MIN; DOCONEXENT; FERROUS FUMARATE; FOLIC ACID; MAGNESIUM OXIDE; POTASSIUM IODIDE
; PYRIDOXINE HYDROCHLORIDE" 10; 85; 500; 155; 1000; 12; 400; 28; 1; 50; 150;
25 [iU]/1; mg/1; ug/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg
/1 "Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/
Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulati
on Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemica
l/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [M
oA]"
75854-310_ca59cff2-82ec-4959-94d0-c46b13db5aca 75854-310 HUMAN PRESCRIPTI
ON DRUG FeRivaFA "ferrous bisglycinate, ascorbic acid, folic acid
, cyanocobalamin, biotin, cupric oxide and docusate sodium" "CAPSULE, GELATI
N COATED" ORAL 20140102 UNAPPROVED DRUG OTHER
"Avion Pharmaceuticals, LLC" ASCORBIC ACID; BIOTIN; CUPRIC OXIDE; CYANOCOBALA
MIN; DOCUSATE SODIUM; FERROUS BISGLYCINATE; FOLIC ACID 175; 300; 1; 12; 50; 110
; 1 mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1 "Vitamin B 12 [Chemical/
Ingredient],Vitamin B12 [EPC]"
75854-311_e853c0be-6cfb-4174-b020-1ea2bc35af1a 75854-311 HUMAN PRESCRIPTI
ON DRUG Prenate Star ".beta.-carotene, ascorbic acid, cholecalciferol
, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic
acid, cyanocobalamin, biotin, calcium pantothenate, calcium formate, ferrous as
parto glycinate, potassium iodide, magnesium oxide, zinc oxide and cupric oxide"
"TABLET, COATED" ORAL 20140605 UNAPPROVED DRUG OTHER
"Avion Pharmaceuticals, LLC" .BETA.-CAROTENE; ASCORBIC ACID; BIOTIN; CALCIUM
FORMATE; CALCIUM PANTOTHENATE; CHOLECALCIFEROL; CUPRIC OXIDE; CYANOCOBALAMIN; FE
RROUS ASPARTO GLYCINATE; FOLIC ACID; MAGNESIUM OXIDE; NIACINAMIDE; POTASSIUM IOD
IDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; ZINC OXIDE
3300; 75; 330; 155; 6; 450; 1.5; 12; 20; 1; 25; 21; 150; 21; 2; 1.5; 15 [iU]/1;
mg/1; ug/1; mg/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1;
mg/1; mg/1; mg/1 "Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin
ivalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exch
ange Activity [MoA],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absor
ption [PE]"
75854-312_8f2eca71-9a82-4a19-9206-36a04b865fe1 75854-312 HUMAN PRESCRIPTI
ON DRUG PRENATE DHA "ascorbic acid, cholecalciferol, .alpha.-tocophe
rol, dl-, folic acid, pyridoxine hydrochloride, cyanocobalamin, calcium formate,
ferrous asparto glycinate, magnesium oxide and doconexent" "CAPSULE, GELATI
"Avion Pharmaceuticals, LLC" ".ALPHA.-TOCOPHEROL, DL-; ASCORBIC ACID; CALCIUM
FORMATE; CHOLECALCIFEROL; CYANOCOBALAMIN; DOCONEXENT; FERROUS ASPARTO GLYCINATE
; FOLIC ACID; MAGNESIUM OXIDE; PYRIDOXINE HYDROCHLORIDE" 40; 90; 155; 400
; 25; 300; 18; 1; 50; 26 [iU]/1; mg/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg
/1; mg/1; mg/1 "Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [C
hemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased C
oagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent
[Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Act
ivity [MoA]"
75854-313_e5acfb2a-0959-4542-9b4c-790be194d581 75854-313 HUMAN PRESCRIPTI
ON DRUG Prenate Essential "ascorbic acid, cholecalciferol, .alpha.
-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, 5-methyltetrahyd
rofolic acid, cyanocobalamin, biotin, calcium formate, ferrous asparto glycinate
, potassium iodide, magnesium oxide, doconexent and icosapent" "CAPSULE, GELATI
"Avion Pharmaceuticals, LLC" ".ALPHA.-TOCOPHEROL ACETATE, DL-; 5-METHYLTETRAH
YDROFOLIC ACID; ASCORBIC ACID; BIOTIN; CALCIUM FORMATE; CHOLECALCIFEROL; CYANOCO
BALAMIN; DOCONEXENT; FERROUS ASPARTO GLYCINATE; FOLIC ACID; ICOSAPENT; MAGNESIUM
OXIDE; POTASSIUM IODIDE; PYRIDOXINE HYDROCHLORIDE" 10; 600; 90; 280; 155; 2
20; 13; 300; 18; 400; 40; 50; 150; 26 [iU]/1; ug/1; mg/1; ug/1; mg/1; [iU]/1;
ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1 "Vitamin D [Chemical/Ingredient]
,Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coag
ulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemica
l/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent
[EPC],Magnesium Ion Exchange Activity [MoA]"
75854-314_9b79c950-4312-4a53-9e36-fb8e00b053df 75854-314 HUMAN PRESCRIPTI
ON DRUG Prenate Elite ".beta.-carotene, ascorbic acid, cholecalciferol
, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide
, pyridoxine hydrochloride, folic acid, 5-methyltetrahydrofolic acid, calcium fo
rmate, ferrous asparto glycinate, cyanocobalamin, biotin, potassium iodide, magn
esium oxide, zinc oxide and cupric oxide" "TABLET, COATED" ORAL
20140605 UNAPPROVED DRUG OTHER "Avion Pharmaceuticals,
LLC" ".ALPHA.-TOCOPHEROL ACETATE, DL-; .BETA.-CAROTENE; 5-METHYLTETRAHYDROFOL
IC ACID; ASCORBIC ACID; BIOTIN; CALCIUM FORMATE; CHOLECALCIFEROL; CUPRIC OXIDE;
CYANOCOBALAMIN; FERROUS ASPARTO GLYCINATE; FOLIC ACID; MAGNESIUM OXIDE; NIACINAM
IDE; POTASSIUM IODIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRAT
E; ZINC OXIDE" 40; 2600; 600; 75; 330; 155; 600; 1.5; 13; 20; 400; 25; 21; 150;
21; 3.5; 3; 15 [iU]/1; [iU]/1; ug/1; mg/1; ug/1; mg/1; [iU]/1; mg/1; ug/1; mg/1
; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1 "Vitamin B 12 [Chemical/
Ingredient],Vitamin B12 [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exch
ange Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor
Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredie
nt],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE],Vitam
in D [Chemical/Ingredient],Vitamin D [EPC]"
75854-342_8ac1cdd0-e6b4-4cdf-9448-a7aaf9cba55b 75854-342 HUMAN PRESCRIPTI
ON DRUG Nicomide "niacinamide, folic acid, zinc oxide and cupric
oxide" TABLET ORAL 20120615 UNAPPROVED DRUG OTHER
"Avion Pharmaceuticals, LLC" CUPRIC OXIDE; FOLIC ACID; NIACINAMIDE; ZINC OXID
E 1.5; 500; 750; 25 mg/1; ug/1; mg/1; mg/1
75854-401_89adbfe5-d148-4c0a-bb41-9093f4e92358 75854-401 HUMAN PRESCRIPTI
ON DRUG Levonorgestrel and Ethinyl Estradoil Levonorgestrel and Ethin
yl Estradoil KIT 20131211 ANDA ANDA090721
"Avion Pharmaceuticals, LLC"
42291-101_cfe9abc2-5cdf-567e-4473-a91556006141 42291-101 HUMAN PRESCRIPTI
CAPSULE ORAL 20091214 ANDA ANDA075047 "AvKARE, Inc."
ACEBUTOLOL HYDROCHLORIDE 200 mg/1 "Adrenergic beta-Antagonists [Mo
42291-102_cfe9abc2-5cdf-567e-4473-a91556006141 42291-102 HUMAN PRESCRIPTI
ACEBUTOLOL HYDROCHLORIDE 400 mg/1 "Adrenergic beta-Antagonists [Mo
42291-103_7d00f989-ac95-973d-fda3-0d77df23c0de 42291-103 HUMAN PRESCRIPTI
ON DRUG AcetaZOLAMIDE Acetazolamide TABLET ORAL 20120702
ANDA ANDA084840 "AvKARE, Inc." ACETAZOLAMIDE 250 mg/1 "Carboni
c Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Ch
emical/Ingredient]"
42291-107_02da3e38-febd-2020-3cea-eb8c49229c4c 42291-107 HUMAN PRESCRIPTI
ANDA ANDA075090 "AvKARE, Inc." ACYCLOVIR 200 mg/1 "DNA Pol
42291-108_90dd081f-d137-3d7b-8190-44ce0fa0c3fd 42291-108 HUMAN PRESCRIPTI
42291-109_90dd081f-d137-3d7b-8190-44ce0fa0c3fd 42291-109 HUMAN PRESCRIPTI
42291-110_67762ce4-8814-080f-345d-bc0d3aca1d8f 42291-110 HUMAN PRESCRIPTI
ON DRUG Alfuzosin Hydrochloride ER Alfuzosin Hydrochloride "TABLET, EXTENDE
D RELEASE" ORAL 20120313 ANDA ANDA079013 "AvKARE,
Inc." ALFUZOSIN HYDROCHLORIDE 10 mg/1 "Adrenergic alpha-Antagonists [M
oA],alpha-Adrenergic Blocker [EPC]"
42291-111_6b8429b3-e43f-6c9c-463a-b0ab723ffe1a 42291-111 HUMAN PRESCRIPTI
ORAL 20130521 ANDA ANDA078387 "AvKARE, Inc." ALPRAZOL
nt]" CIV
nt]" CIV
nt]" CIV
42291-120_6f5fe7a9-f6cf-136b-e197-332d47a18af6 42291-120 HUMAN PRESCRIPTI
ANDA ANDA062058 "AvKARE, Inc." AMOXICILLIN 250 mg/1 "Penicil
42291-121_6f5fe7a9-f6cf-136b-e197-332d47a18af6 42291-121 HUMAN PRESCRIPTI
ANDA ANDA062058 "AvKARE, Inc." AMOXICILLIN 500 mg/1 "Penicil
42291-122_963b7530-fa52-294a-ed5a-c3af4e749ab8 42291-122 HUMAN PRESCRIPTI
ON DRUG Amiloride Hydrochloride Amiloride Hydrochloride TABLET ORAL
20120328 ANDA ANDA079133 "AvKARE, Inc." AMILORIDE HYDROC
HLORIDE 5 mg/1 "Decreased Renal K+ Excretion [PE],Increased Diuresis [P
E],Potassium-sparing Diuretic [EPC]"
42291-125_5f26d452-9598-fd44-b33a-071c25876913 42291-125 HUMAN PRESCRIPTI
ON DRUG Amantadine HCl AMANTADINE HYDROCHLORIDE "CAPSULE, LIQUID
FILLED" ORAL 20130807 ANDA ANDA078720 "AvKARE,
Inc." AMANTADINE HYDROCHLORIDE 100 mg/1 "Influenza A M2 Protein
Inhibitor [EPC],M2 Protein Inhibitors [MoA]"
42291-130_80544ec3-50c2-6b46-09bc-a6bacb8630d4 42291-130 HUMAN PRESCRIPTI
ON DRUG acarbose acarbose TABLET ORAL 20131224
ANDA ANDA091343 "AvKARE, Inc." ACARBOSE 25 mg/1 "alpha G
lucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC]"
42291-140_028c547f-f666-2de8-d117-9aaf42a5c9a8 42291-140 HUMAN PRESCRIPTI
ANDA ANDA074056 "AvKARE, Inc." ATENOLOL 25 mg/1 "Adrener
42291-143_090a2b62-2d72-7d03-069b-12bb45477099 42291-143 HUMAN PRESCRIPTI
ATED" ORAL 20130708 ANDA ANDA091624 "AvKARE, Inc."
42291-158_a39aa94d-a744-bb77-a7a0-98e4e120dbb5 42291-158 HUMAN PRESCRIPTI
ON DRUG Baclofen baclofen TABLET ORAL 20140825
ANDA ANDA078220 "AvKARE, Inc." BACLOFEN 10 mg/1 "GABA A
Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC]
"
42291-159_a39aa94d-a744-bb77-a7a0-98e4e120dbb5 42291-159 HUMAN PRESCRIPTI
ON DRUG Baclofen baclofen TABLET ORAL 20140825
ANDA ANDA077241 "AvKARE, Inc." BACLOFEN 20 mg/1 "GABA A
Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC]
"
42291-160_b7260084-8ae9-642a-4b8f-d6879101d313 42291-160 HUMAN PRESCRIPTI
TABLET ORAL 20090729 ANDA ANDA076820 "AvKARE, Inc."
BENAZEPRIL HYDROCHLORIDE 5 mg/1 "Angiotensin Converting Enzyme I
essure [PE]"
essure [PE]"
essure [PE]"
essure [PE]"
42291-168_14193044-7ce3-f458-1954-2aae1b47be84 42291-168 HUMAN PRESCRIPTI
ON DRUG Bicalutamide Bicalutamide "TABLET, FILM COATED" ORAL
20140113 ANDA ANDA076932 "AvKARE, Inc." BICALUTAMIDE
50 mg/1 "Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor
[EPC]"
42291-169_50dca1e3-7983-134c-824f-6fff9f0110a4 42291-169 HUMAN PRESCRIPTI
20100401 ANDA ANDA040855 "AvKARE, Inc." BETHANECHOL CHLO
RIDE 25 mg/1 "Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscar
inic Agonists [MoA]"
42291-170_50dca1e3-7983-134c-824f-6fff9f0110a4 42291-170 HUMAN PRESCRIPTI
20100401 ANDA ANDA040855 "AvKARE, Inc." BETHANECHOL CHLO
RIDE 50 mg/1 "Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscar
inic Agonists [MoA]"
42291-174_2f1d3045-0ff2-e8e6-a721-41f039c3cf54 42291-174 HUMAN PRESCRIPTI
"AvKARE, Inc." BUPRENORPHINE; NALOXONE 2; .5 mg/1; mg/1 "Partial Opioid
Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antag
onists [MoA]" CIII
42291-175_2f1d3045-0ff2-e8e6-a721-41f039c3cf54 42291-175 HUMAN PRESCRIPTI
"AvKARE, Inc." BUPRENORPHINE; NALOXONE 8; 2 mg/1; mg/1 "Partial Opioid
Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antag
onists [MoA]" CIII
42291-176_d1724a42-956e-3f33-3e04-b62eaf85ec35 42291-176 HUMAN PRESCRIPTI
20130828 ANDA ANDA075467 "AvKARE, Inc." BUSPIRONE HYDROC
HLORIDE 7.5 mg/1
42291-177_137a9486-9e0c-a8ec-b1c6-52f9194159c0 42291-177 HUMAN PRESCRIPTI
20131017 ANDA ANDA075022 "AvKARE, Inc." BUSPIRONE HYDROC
HLORIDE 30 mg/1
42291-196_59a26aef-eb5d-4146-9a7e-0cdaf24f4bec 42291-196 HUMAN PRESCRIPTI
ON DRUG carvedilol carvedilol "TABLET, FILM COATED" ORAL
20140114 ANDA ANDA077346 "AvKARE, Inc." CARVEDILOL
42291-200_7f8dc6b0-daf3-6991-2ef7-d1db51fb61eb 42291-200 HUMAN PRESCRIPTI
ANDA ANDA040823 "AvKARE, Inc." CARISOPRODOL 350 mg/1 "Central
ly-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]" CIV
42291-208_e29e8545-342f-0f62-ca96-73f6a3c20027 42291-208 HUMAN PRESCRIPTI
ANDA ANDA062713 "AvKARE, Inc." CEPHALEXIN 250 mg/1 "Cephalo
42291-209_e29e8545-342f-0f62-ca96-73f6a3c20027 42291-209 HUMAN PRESCRIPTI
ANDA ANDA062713 "AvKARE, Inc." CEPHALEXIN 500 mg/1 "Cephalo
42291-210_0629a0ad-ade8-9081-ddef-767583fb9936 42291-210 HUMAN PRESCRIPTI
61 "AvKARE, Inc." CHLORDIAZEPOXIDE HYDROCHLORIDE 5 mg/1 "Benzodi
42291-214_ed680384-d0f0-cde7-4861-ea346039c5e6 42291-214 HUMAN PRESCRIPTI
ON DRUG Chlordiazepoxide Hydrochloride/Clidinium Bromide Chlordia
zepoxide Hydrochloride and Clidinium Bromide CAPSULE ORAL 20131119
UNAPPROVED DRUG OTHER "AvKARE, Inc." CHLORDIAZEPOXIDE HYDROCHLORIDE;
CLIDINIUM BROMIDE 5; 2.5 mg/1; mg/1 "Benzodiazepine [EPC],Benzodiaze
pines [Chemical/Ingredient],Anticholinergic [EPC],Decreased Parasympathetic Acet
ylcholine Activity [PE],GI Motility Alteration [PE],Digestive/GI System Activity
Alteration [PE],Cholinergic Antagonists [MoA]"
42291-218_667d4974-dc65-1e3c-5a23-1f0aa3ec1051 42291-218 HUMAN PRESCRIPTI
ON DRUG Cimetidine Cimetidine "TABLET, FILM COATED" ORAL
20130723 ANDA ANDA074151 "AvKARE, Inc." CIMETIDINE
tagonist [EPC]"
42291-219_9ee6c321-7d00-260a-2b1d-3dc99176665d 42291-219 HUMAN PRESCRIPTI
20140616 ANDA ANDA076126 "AvKARE, Inc." CIPROFLOXACIN HY
DROCHLORIDE 250 mg/1 "Quinolone Antimicrobial [EPC],Quinolones [Chemi
cal/Ingredient]"
42291-220_7627f366-b40a-57cf-d8c0-8d3f0c4da710 42291-220 HUMAN OTC DRUG
ORAL 20130821 ANDA ANDA077498 "AvKARE, Inc." CETIRIZI
42291-221_12618218-415b-bcb7-4213-92eff5f5020e 42291-221 HUMAN PRESCRIPTI
42291-225_bcdabfc8-41d4-8f10-5d65-fd7bb4fa688a 42291-225 HUMAN PRESCRIPTI
ON DRUG CYPROHEPTADINE HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE
CYPROHEPTADINE HYDROCHLORIDE 4 mg/1
42291-226_67d75148-68ca-3263-423f-8613a0d90064 42291-226 HUMAN PRESCRIPTI
ANDA078214 "AvKARE, Inc." DANAZOL 50 mg/1 "Androgen [EPC],Androgen
Receptor Agonists [MoA],Androstanes [Chemical/Ingredient]"
42291-229_4da8d556-0c74-2ec0-8065-27b63898f78f 42291-229 HUMAN PRESCRIPTI
ON DRUG Desloratadine Desloratadine TABLET ORAL 20120705
ANDA ANDA078355 "AvKARE, Inc." DESLORATADINE 5 mg/1 "Histami
ne H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]"
42291-230_ca0eb727-286c-e326-9e1d-126f19a0edc0 42291-230 HUMAN PRESCRIPTI
RELEASE" ORAL 19981113 ANDA ANDA075185 "AvKARE,
Inc." DICLOFENAC SODIUM 50 mg/1 "Cyclooxygenase Inhibitors [MoA]
,Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compound
42291-231_ca0eb727-286c-e326-9e1d-126f19a0edc0 42291-231 HUMAN PRESCRIPTI
Inc." DICLOFENAC SODIUM 75 mg/1 "Cyclooxygenase Inhibitors [MoA]
,Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compound
42291-232_59fe8b9a-221f-a848-bc86-ee843bb743b8 42291-232 HUMAN PRESCRIPTI
ON DRUG Diclofenac Sodium and Misoprostol Diclofenac Sodium and Mi
soprostol "TABLET, DELAYED RELEASE" ORAL 20121214
ANDA ANDA201089 "AvKARE, Inc." DICLOFENAC SODIUM; MISOPROSTOL 50; 200
mg/1; ug/1 "Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Product
ion [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonstero
idal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E
, Synthetic [Chemical/Ingredient]"
42291-233_59fe8b9a-221f-a848-bc86-ee843bb743b8 42291-233 HUMAN PRESCRIPTI
ON DRUG Diclofenac Sodium and Misoprostol Diclofenac Sodium and Mi
soprostol "TABLET, DELAYED RELEASE" ORAL 20121214
ANDA ANDA201089 "AvKARE, Inc." DICLOFENAC SODIUM; MISOPROSTOL 75; 200
mg/1; ug/1 "Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Product
ion [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonstero
idal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E
, Synthetic [Chemical/Ingredient]"
42291-234_201650d3-2f6b-aaa6-5c13-8edff6813bd6 42291-234 HUMAN PRESCRIPTI
ON DRUG Disopyramide Phosphate Disopyramide Phosphate CAPSULE ORAL
20140103 ANDA ANDA070101 "AvKARE, Inc." DISOPYRAMIDE PHO
SPHATE 100 mg/1 Antiarrhythmic [EPC]
42291-235_201650d3-2f6b-aaa6-5c13-8edff6813bd6 42291-235 HUMAN PRESCRIPTI
ON DRUG Disopyramide Phosphate Disopyramide Phosphate CAPSULE ORAL
20140103 ANDA ANDA070102 "AvKARE, Inc." DISOPYRAMIDE PHO
SPHATE 150 mg/1 Antiarrhythmic [EPC]
42291-236_b88b1b67-411a-23b3-1129-b589050d7096 42291-236 HUMAN PRESCRIPTI
ON DRUG Diltiazem Hydrochloride Diltiazem hydrochloride "CAPSULE, EXTEND
ED RELEASE" ORAL 20140109 ANDA ANDA075116 "AvKARE,
Inc." DILTIAZEM HYDROCHLORIDE 120 mg/1 "Calcium Channel Antagonists [Mo
42291-244_7a678d53-d67d-9cbf-e229-eab14b716233 42291-244 HUMAN PRESCRIPTI
ON DRUG Donnatal phenobarbital elixir ELIXIR ORAL 20140113
UNAPPROVED DRUG OTHER "AvKARE, Inc." ATROPINE SULFATE; HYOSCYAMINE SU
LFATE; PHENOBARBITAL; SCOPOLAMINE HYDROBROMIDE .0194; .1037; 16.2; .0065
mg/5mL; mg/5mL; mg/5mL; mg/5mL "Anticholinergic [EPC],Cholinergic Antagonists [
MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic
42291-245_fa8f553a-c2ce-6b80-12ed-a078885dd6d9 42291-245 HUMAN PRESCRIPTI
ON DRUG Donnatal "Phenobarbital, Hyoscyamine Sulfate, Atropine Su
lfate, Scopolamine Hydrobromide" TABLET ORAL 20140106
UNAPPROVED DRUG OTHER "AvKARE, Inc." ATROPINE SULFATE; HYOSCYAMINE SU
LFATE; PHENOBARBITAL; SCOPOLAMINE HYDROBROMIDE .0194; .1037; 16.2; .0065
mg/1; mg/1; mg/1; mg/1 "Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cho
linergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],An
ticholinergic [EPC],Cholinergic Antagonists [MoA]"
42291-247_5a19c0f2-d364-a551-1e59-68374c058969 42291-247 HUMAN PRESCRIPTI
ON DRUG Doxepin Hydrochloride Doxepin Hydrochloride CAPSULE ORAL
20120831 ANDA ANDA071669 "AvKARE, Inc." DOXEPIN HYDROCHL
ORIDE 150 mg/1 Tricyclic Antidepressant [EPC]
42291-248_87a134e4-e2ad-1fd3-f69b-1012d3132ef4 42291-248 HUMAN PRESCRIPTI
20130723 ANDA ANDA062675 "AvKARE, Inc." DOXYCYCLINE HYCL
ATE 50 mg/1
20130723 ANDA ANDA062676 "AvKARE, Inc." DOXYCYCLINE HYCL
ATE 100 mg/1
42291-251_e0c2057b-8819-1ccd-8654-4bb2e415a5ae 42291-251 HUMAN PRESCRIPTI
ORAL 20140708 ANDA ANDA090776 "AvKARE, Inc." DULOXETI
NE HYDROCHLORIDE 20 mg/1 "Norepinephrine Uptake Inhibitors [MoA],
Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitor
s [MoA]"
s [MoA]"
s [MoA]"
42291-267_ca7ddd8c-1d54-3df5-e59e-71a7d2a69194 42291-267 HUMAN PRESCRIPTI
ON DRUG Ergoloid Mesylates "Dihydroergocornine Mesylate, Dihydroerg
ocristine Mesylate, Dihydro-.alpha.-ergocryptine mesylate, and Dihydro-.beta.-er
gocryptine mesylate" TABLET ORAL 20140822 ANDA ANDA0811
13 "AvKARE, Inc." DIHYDRO-.ALPHA.-ERGOCRYPTINE MESYLATE; DIHYDRO-.BETA.-ER
GOCRYPTINE MESYLATE; DIHYDROERGOCORNINE MESYLATE; DIHYDROERGOCRISTINE MESYLATE
.222; .111; .333; .333 mg/1; mg/1; mg/1; mg/1
42291-268_2456a3d6-8ea2-67b3-dacb-1a6ba2294b11 42291-268 HUMAN PRESCRIPTI
ON DRUG Entacapone Entacapone "TABLET, FILM COATED" ORAL
20140620 NDA AUTHORIZED GENERIC NDA020796 "AvKARE, Inc."
ENTACAPONE 200 mg/1 "Catechol O-Methyltransferase Inhibitors [MoA],C
atechol-O-Methyltransferase Inhibitor [EPC]"
42291-269_bfd2ae86-755a-c0c3-733a-3f2a7f8d380a 42291-269 HUMAN PRESCRIPTI
ON DRUG Enalapril Maleate and Hydrochlorothiazide Enalapril Maleat
e and Hydrochlorothiazide TABLET ORAL 20130722 ANDA
ANDA075727 "AvKARE, Inc." ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE 10; 25
42291-270_0e15c744-1ee1-363d-28ef-7e78acea5aca 42291-270 HUMAN PRESCRIPTI
ON DRUG Epinastine HCl epinastine hydrochloride SOLUTION
OPHTHALMIC 20111115 ANDA ANDA090870 "AvKARE, Inc."
EPINASTINE HYDROCHLORIDE 0.5 mg/mL "Adrenergic Agonists [MoA],Adren
ergic Receptor Agonist [EPC],Decreased Histamine Release [PE],Histamine H1 Recep
tor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC]"
42291-271_5777d4d5-5ff6-c51c-e0a3-1641dd767d11 42291-271 HUMAN PRESCRIPTI
20140515 ANDA ANDA091169 "AvKARE, Inc." ESZOPICLONE
1 mg/1 CIV
2 mg/1 CIV
3 mg/1 CIV
42291-274_d9a26597-7fad-b72a-8457-c60690db8487 42291-274 HUMAN PRESCRIPTI
ON DRUG Ergocalciferol Ergocalciferol "CAPSULE, LIQUID FILLED"
ORAL 20120605 ANDA ANDA091004 "AvKARE, Inc." ERGOCALC
IFEROL 1.25 mg/1 "Ergocalciferols [Chemical/Ingredient],Provitamin D2 Com
pound [EPC]"
42291-275_eeabed71-944a-e001-be49-b0d97813a2a7 42291-275 HUMAN PRESCRIPTI
20120104 ANDA ANDA077487 "AvKARE, Inc." FAMCICLOVIR
42291-278_b21165bb-0d27-dcf6-e8ff-f47cd06ee803 42291-278 HUMAN PRESCRIPTI
ON DRUG Fluoxetine Hydrochloride fluoxetine hydrochloride
"AvKARE, Inc." FLUOXETINE HYDROCHLORIDE 10 mg/1 "Serotonin Reupt
42291-279_b21165bb-0d27-dcf6-e8ff-f47cd06ee803 42291-279 HUMAN PRESCRIPTI
ON DRUG Fluoxetine Hydrochloride fluoxetine hydrochloride
"AvKARE, Inc." FLUOXETINE HYDROCHLORIDE 20 mg/1 "Serotonin Reupt
42291-280_e2a2e915-312b-55d9-46b3-6d24ea4b2492 42291-280 HUMAN PRESCRIPTI
20130226 ANDA ANDA076511 "AvKARE, Inc." FINASTERIDE
[MoA]"
42291-281_832559de-19ef-e69c-547a-36c6b3f9b4f8 42291-281 HUMAN PRESCRIPTI
ON DRUG Famotidine Famotidine TABLET ORAL 20130918
ANDA ANDA075805 "AvKARE, Inc." FAMOTIDINE 20 mg/1 "Histami
ne H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]"
42291-283_f16c5db4-d32c-df09-6d1b-f49cc2020173 42291-283 HUMAN PRESCRIPTI
ON DRUG Fluocinolone Acetonide Fluocinolone Acetonide OIL AURICULA
R (OTIC) 20131218 ANDA ANDA091306 "AvKARE, Inc."
FLUOCINOLONE ACETONIDE 0.11 mg/20mL "Corticosteroid [EPC],Corticosteroid Hor
42291-284_106e5489-d635-7df0-8df4-f33020e395d3 42291-284 HUMAN PRESCRIPTI
20131217 ANDA ANDA201759 "AvKARE, Inc." FLUOCINOLONE ACE
TONIDE 0.11 mg/118.28mL "Corticosteroid [EPC],Corticosteroid Hormone Rec
42291-285_f8397c3f-9b37-7f64-654e-79bd1983705f 42291-285 HUMAN PRESCRIPTI
20131217 ANDA ANDA201764 "AvKARE, Inc." FLUOCINOLONE ACE
TONIDE 0.11 mg/118.28mL "Corticosteroid [EPC],Corticosteroid Hormone Rec
42291-286_7f1d2f15-0211-6ed2-7fb4-fd7755a08557 42291-286 HUMAN PRESCRIPTI
ELEASE" ORAL 20140331 ANDA ANDA075896 "AvKARE, Inc."
FELODIPINE 2.5 mg/1 "Calcium Channel Antagonists [MoA],Dihydropyridi
FELODIPINE 5 mg/1 "Calcium Channel Antagonists [MoA],Dihydropyridi
FELODIPINE 10 mg/1 "Calcium Channel Antagonists [MoA],Dihydropyridi
42291-300_d484042e-d2cd-8e59-08e8-a1edeb5096a9 42291-300 HUMAN PRESCRIPTI
ANDA ANDA078428 "AvKARE, Inc." GABAPENTIN 100 mg/1 "Anti-ep
ivity [PE]"
ivity [PE]"
ivity [PE]"
42291-305_24cc5efd-029e-8261-53f0-2047468d3284 42291-305 HUMAN PRESCRIPTI
ON DRUG Glipizide and Metformin Hydrochloride Glipizide and Metformin
ANDA077270 "AvKARE, Inc." GLIPIZIDE; METFORMIN HYDROCHLORIDE 2.5; 500
mg/1; mg/1 "Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient]
,Biguanide [EPC],Biguanides [Chemical/Ingredient]"
42291-306_24cc5efd-029e-8261-53f0-2047468d3284 42291-306 HUMAN PRESCRIPTI
ON DRUG Glipizide and Metformin Hydrochloride Glipizide and Metformin
ANDA077270 "AvKARE, Inc." GLIPIZIDE; METFORMIN HYDROCHLORIDE 5; 500
mg/1; mg/1 "Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient]
,Biguanide [EPC],Biguanides [Chemical/Ingredient]"
42291-310_9f3bdd38-af25-8140-cde5-303d29a8d1f0 42291-310 HUMAN PRESCRIPTI
GUANFACINE HYDROCHLORIDE 1 mg/1 "Adrenergic alpha2-Agonists [MoA
42291-311_9f3bdd38-af25-8140-cde5-303d29a8d1f0 42291-311 HUMAN PRESCRIPTI
GUANFACINE HYDROCHLORIDE 2 mg/1 "Adrenergic alpha2-Agonists [MoA
42291-312_ecf961d2-dfd7-5011-45d6-197f3a8b1466 42291-312 HUMAN OTC DRUG
GUAIFENESIN GUAIFENESIN TABLET ORAL 20120516
OTC MONOGRAPH FINAL part341 "AvKARE, Inc." GUAIFENESIN 400 mg/1
42291-313_8888deda-bd70-1819-2d9b-7f5cf6077f98 42291-313 HUMAN OTC DRUG
Guaifenesin Guaifenesin TABLET ORAL 20131104
OTC MONOGRAPH FINAL part341 "AvKARE, Inc." GUAIFENESIN 200 mg/1
42291-318_e5da61bc-ddf9-aac2-6115-7adb49e66a62 42291-318 HUMAN PRESCRIPTI
"AvKARE, Inc." HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Ag
ent [EPC]
42291-319_edf31c7d-0e6a-3048-7660-4711949eb7d0 42291-319 HUMAN PRESCRIPTI
"AvKARE, Inc." HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Ag
ent [EPC]
42291-320_a93a4562-b230-a9f6-3e16-2ced0e1e09e8 42291-320 HUMAN PRESCRIPTI
HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC]
42291-321_4f4032b3-82cd-b8b6-20fb-1474aee9f154 42291-321 HUMAN PRESCRIPTI
ON DRUG HYDROXYUREA Hydroxyurea CAPSULE ORAL 20130719
ANDA ANDA075143 "AvKARE, Inc." HYDROXYUREA 500 mg/1 "Antimet
abolite [EPC],Urea [Chemical/Ingredient]"
42291-322_b22c01cb-641a-7d71-5616-52b85df22d7b 42291-322 HUMAN PRESCRIPTI
20130307 ANDA ANDA040156 "AvKARE, Inc." HYDROXYZINE PAMO
ATE 25 mg/1 "Antihistamine [EPC],Histamine Receptor Antagonists [MoA
]"
42291-323_b22c01cb-641a-7d71-5616-52b85df22d7b 42291-323 HUMAN PRESCRIPTI
20130307 ANDA ANDA040156 "AvKARE, Inc." HYDROXYZINE PAMO
ATE 50 mg/1 "Antihistamine [EPC],Histamine Receptor Antagonists [MoA
]"
42291-336_24db04cd-1d5f-69ad-1ae4-a930fcc91125 42291-336 HUMAN PRESCRIPTI
ON DRUG Ibandronate Sodium ibandronate sodium TABLET ORAL
20131204 ANDA ANDA079003 "AvKARE, Inc." IBANDRONATE SODI
t]"
42291-337_44610af5-87da-8d4c-19e3-101695a2807b 42291-337 HUMAN PRESCRIPTI
ANDA ANDA078558 "AvKARE, Inc." IBUPROFEN 400 mg/1 "Cycloox
42291-342_77b457f2-fbe6-393c-0d5e-4ee0d41740a3 42291-342 HUMAN PRESCRIPTI
"AvKARE, Inc." HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5; 150 mg/1; mg/1
42291-343_77b457f2-fbe6-393c-0d5e-4ee0d41740a3 42291-343 HUMAN PRESCRIPTI
"AvKARE, Inc." HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5; 300 mg/1; mg/1
42291-360_7e77cde8-d199-95f0-01d8-3d2ba128f54e 42291-360 HUMAN PRESCRIPTI
ANDA ANDA073516 "AvKARE, Inc." KETOPROFEN 50 mg/1 "Cycloox
42291-361_7e77cde8-d199-95f0-01d8-3d2ba128f54e 42291-361 HUMAN PRESCRIPTI
ANDA ANDA073517 "AvKARE, Inc." KETOPROFEN 75 mg/1 "Cycloox
42291-363_2f4b35da-3910-9da8-b0a5-11bcce1e35b6 42291-363 HUMAN PRESCRIPTI
"AvKARE, Inc." LAMIVUDINE; ZIDOVUDINE 150; 300 mg/1; mg/1 "Hepatit
is B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunod
eficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleosi
de Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA
],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
[EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase
Inhibitors [MoA]"
42291-364_29507842-8ccd-f676-7e66-6beecb22fac9 42291-364 HUMAN PRESCRIPTI
ORAL 20130805 ANDA ANDA077255 "AvKARE, Inc." LANSOPRA
]"
42291-365_29507842-8ccd-f676-7e66-6beecb22fac9 42291-365 HUMAN PRESCRIPTI
ORAL 20130805 ANDA ANDA077255 "AvKARE, Inc." LANSOPRA
]"
42291-366_c8c34828-a331-f35d-d38f-cbc15f5f5bfd 42291-366 HUMAN PRESCRIPTI
ANDA ANDA079132 "AvKARE, Inc." LAMOTRIGINE 25 mg/1 "Anti-ep
42291-370_09aa85f3-d88e-cd12-eeb8-bd00d8039826 42291-370 HUMAN PRESCRIPTI
20130712 ANDA ANDA076361 "AvKARE, Inc." LEVOFLOXACIN
250 mg/1
500 mg/1
750 mg/1
42291-375_96594000-fd74-55dd-07ad-ef8db7a02374 42291-375 HUMAN PRESCRIPTI
ANDA ANDA075991 "AvKARE, Inc." LOVASTATIN 10 mg/1 "HMG-CoA
42291-380_6583f7c1-40b6-c355-b007-81b868b1b28f 42291-380 HUMAN PRESCRIPTI
ON DRUG Levetiracetam levetiracetam TABLET ORAL 20051228
ANDA ANDA078106 "AvKARE, Inc." LEVETIRACETAM 250 mg/1 "Anti-ep
ivity [PE]"
ivity [PE]"
ivity [PE]"
ivity [PE]"
42291-390_6e7f7a9c-412a-b584-473e-747268402822 42291-390 HUMAN PRESCRIPTI
"AvKARE, Inc." HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1
l/Ingredient]"
"AvKARE, Inc." HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1
l/Ingredient]"
"AvKARE, Inc." HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 "Angiote
ient]"
42291-509_5d368e91-0f11-5d3a-4df9-9659cdb7e362 42291-509 HUMAN PRESCRIPTI
ANDA ANDA040866 "AvKARE, Inc." PRIMIDONE 50 mg/1 "Anti-ep
ivity [PE]"
42291-511_5d368e91-0f11-5d3a-4df9-9659cdb7e362 42291-511 HUMAN PRESCRIPTI
ANDA ANDA040866 "AvKARE, Inc." PRIMIDONE 250 mg/1 "Anti-ep
ivity [PE]"
42291-526_4da66c17-f47d-0fb3-c8da-18a581119dbe 42291-526 HUMAN PRESCRIPTI
ON DRUG DIPYRIDAMOLE DIPYRIDAMOLE "TABLET, FILM COATED" ORAL
20070708 ANDA ANDA040782 "AvKARE, Inc." DIPYRIDAMOLE
25 mg/1 "Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibi
tor [EPC]"
tor [EPC]"
tor [EPC]"
42291-529_56a624ce-b1bc-5ad6-7e74-614c0e8502ed 42291-529 HUMAN PRESCRIPTI
ON DRUG FLUDROCORTISONE ACETATE FLUDROCORTISONE ACETATE TABLET ORAL
20020318 ANDA ANDA040431 "AvKARE, Inc." FLUDROCORTISONE
ACETATE 0.1 mg/1
42291-530_e5f68879-b38b-baa8-690e-f5e4c0b365db 42291-530 HUMAN PRESCRIPTI
ON DRUG ORPHENADRINE CITRATE ORPHENADRINE CITRATE TABLET ORAL
20000624 ANDA ANDA040368 "AvKARE, Inc." ORPHENADRINE CIT
RATE 100 mg/1 "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxa
nt [EPC]"
42291-531_593f3040-93e0-9248-bef4-c01c20863194 42291-531 HUMAN PRESCRIPTI
ON DRUG NAPROXEN SODIUM NAPROXEN SODIUM TABLET ORAL 20070426
ANDA ANDA078432 "AvKARE, Inc." NAPROXEN SODIUM 275 mg/1 "Cycloox
42291-532_593f3040-93e0-9248-bef4-c01c20863194 42291-532 HUMAN PRESCRIPTI
ON DRUG NAPROXEN SODIUM NAPROXEN SODIUM TABLET ORAL 20070426
ANDA ANDA078432 "AvKARE, Inc." NAPROXEN SODIUM 550 mg/1 "Cycloox
42291-550_46a544f6-f4a1-4877-a07a-484a42c84644 42291-550 HUMAN PRESCRIPTI
ON DRUG Propylthiouracil Propylthiouracil TABLET ORAL
19970101 ANDA ANDA080154 "AvKARE, Inc." PROPYLTHIOURACIL
50 mg/1 "Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synth
esis Inhibitors [MoA]"
42291-599_529443f8-22dd-9a95-a241-1c5ff217d51b 42291-599 HUMAN PRESCRIPTI
ANDA ANDA076715 "AvKARE, Inc." MODAFINIL 100 mg/1 "Central
42291-600_529443f8-22dd-9a95-a241-1c5ff217d51b 42291-600 HUMAN PRESCRIPTI
ANDA ANDA076715 "AvKARE, Inc." MODAFINIL 200 mg/1 "Central
42291-605_24b7af7b-0df1-3c81-d080-7354fb729ecf 42291-605 HUMAN PRESCRIPTI
20120626 ANDA ANDA077880 "AvKARE, Inc." METFORMIN HYDROC
HLORIDE 500 mg/1 "Biguanide [EPC],Biguanides [Chemical/Ingredient]"
42291-608_614ecd56-b955-cb6d-d73b-20be06aacc58 42291-608 HUMAN PRESCRIPTI
ANDA ANDA201451 "AvKARE, Inc." MECLIZINE HYDROCHLORIDE 12.5 mg/1
"Antiemetic [EPC],Emesis Suppression [PE]"
42291-609_614ecd56-b955-cb6d-d73b-20be06aacc58 42291-609 HUMAN PRESCRIPTI
20120504 ANDA ANDA201451 "AvKARE, Inc." MECLIZINE HYDROC
HLORIDE 25 mg/1 "Antiemetic [EPC],Emesis Suppression [PE]"
42291-610_37050ba0-8bc4-12ef-7fac-0b9cb8d8ad95 42291-610 HUMAN PRESCRIPTI
Inc." METFORMIN HYDROCHLORIDE 500 mg/1 "Biguanide [EPC],Biguanides [Che
mical/Ingredient]"
42291-611_37050ba0-8bc4-12ef-7fac-0b9cb8d8ad95 42291-611 HUMAN PRESCRIPTI
Inc." METFORMIN HYDROCHLORIDE 750 mg/1 "Biguanide [EPC],Biguanides [Che
mical/Ingredient]"
42291-615_c63c23ed-0f62-08d5-9bf5-c8939c69220c 42291-615 HUMAN PRESCRIPTI
ON DRUG MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET ORAL
20040527 ANDA ANDA076449 "AvKARE, Inc." MIDODRINE HYDROC
HLORIDE 2.5 mg/1 "Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonis
t [EPC]"
t [EPC]"
t [EPC]"
42291-618_ad0ed73a-519f-44b8-f4d1-be1d490d6a3d 42291-618 HUMAN PRESCRIPTI
ON DRUG MINOXIDIL minoxidil TABLET ORAL 20130801
ANDA ANDA072708 "AvKARE, Inc." MINOXIDIL 2.5 mg/1 "Arterio
lar Vasodilation [PE],Arteriolar Vasodilator [EPC]"
42291-619_ad0ed73a-519f-44b8-f4d1-be1d490d6a3d 42291-619 HUMAN PRESCRIPTI
ON DRUG MINOXIDIL minoxidil TABLET ORAL 20130801
ANDA ANDA072709 "AvKARE, Inc." MINOXIDIL 10 mg/1 "Arterio
lar Vasodilation [PE],Arteriolar Vasodilator [EPC]"
42291-620_f17b8cdb-0f38-b327-85e9-64381817dd81 42291-620 HUMAN PRESCRIPTI
MINOCYCLINE HYDROCHLORIDE 100 mg/1 "Tetracycline-class Drug [EPC],T
etracyclines [Chemical/Ingredient]"
42291-621_7ee94824-05a6-cd3d-ee22-8916ad38c4ab 42291-621 HUMAN PRESCRIPTI
E" ORAL 20130102 ANDA ANDA200405 "AvKARE, Inc."
E" ORAL 20130102 ANDA ANDA200405 "AvKARE, Inc."
42291-624_b1fbaf51-0752-96de-3790-c7d3b02ea62c 42291-624 HUMAN PRESCRIPTI
ON DRUG Mexiletine Hydrochloride Mexiletine Hydrochloride
MEXILETINE HYDROCHLORIDE 150 mg/1 Antiarrhythmic [EPC]
42291-627_2bb57488-286f-4d1b-8ed5-a404f0c982b7 42291-627 HUMAN PRESCRIPTI
ON DRUG Nefazodone Hydrochloride Nefazodone Hydrochloride
NEFAZODONE HYDROCHLORIDE 250 mg/1 Serotonin Reuptake Inhibitor [EP
C]
42291-628_dba004aa-2103-bf7a-a1ca-8611696fca88 42291-628 HUMAN PRESCRIPTI
ANDA ANDA075927 "AvKARE, Inc." NAPROXEN 500 mg/1 "Cycloox
42291-629_970dc7a9-4bea-90be-9a0e-da94e7efdee6 42291-629 HUMAN PRESCRIPTI
ON DRUG Naproxen delayed release Naproxen TABLET ORAL 20131024
42291-630_970dc7a9-4bea-90be-9a0e-da94e7efdee6 42291-630 HUMAN PRESCRIPTI
ON DRUG Naproxen delayed release Naproxen TABLET ORAL 20131024
42291-631_2bb57488-286f-4d1b-8ed5-a404f0c982b7 42291-631 HUMAN PRESCRIPTI
ON DRUG Nefazodone Hydrochloride Nefazodone Hydrochloride
NEFAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EP
C]
42291-638_96ba6aa3-d932-7b1e-8370-31e4690f7f58 42291-638 HUMAN PRESCRIPTI
20140120 ANDA ANDA075189 "AvKARE, Inc." NABUMETONE
42291-639_96ba6aa3-d932-7b1e-8370-31e4690f7f58 42291-639 HUMAN PRESCRIPTI
20140120 ANDA ANDA075189 "AvKARE, Inc." NABUMETONE
42291-640_38533cfc-f514-4831-6b27-3b5b289553dd 42291-640 HUMAN PRESCRIPTI
NICARDIPINE HYDROCHLORIDE 20 mg/1 "Calcium Channel Antagonists [Mo
edient]"
42291-641_38533cfc-f514-4831-6b27-3b5b289553dd 42291-641 HUMAN PRESCRIPTI
NICARDIPINE HYDROCHLORIDE 30 mg/1 "Calcium Channel Antagonists [Mo
edient]"
42291-642_d4c0063c-25db-6502-3929-690dba132d01 42291-642 HUMAN PRESCRIPTI
20140523 UNAPPROVED DRUG OTHER "AvKARE, Inc." LEVOTHYR
OXINE; LIOTHYRONINE 19; 4.5 ug/1; ug/1 "l-Thyroxine [EPC],Thyroxine [Ch
emical/Ingredient],l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredien
t]"
OXINE; LIOTHYRONINE 38; 9 ug/1; ug/1 "l-Thyroxine [EPC],Thyroxine [Ch
emical/Ingredient],l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredien
t]"
OXINE; LIOTHYRONINE 57; 13.5 ug/1; ug/1 "l-Thyroxine [EPC],Thyro
xine [Chemical/Ingredient],l-Triiodothyronine [EPC],Triiodothyronine [Chemical/I
ngredient]"
42291-648_949f431e-88fa-2b22-0e04-a27e21b83718 42291-648 HUMAN PRESCRIPTI
ON DRUG Nitroglycerin ER Nitroglycerin CAPSULE ORAL 20121219
UNAPPROVED DRUG OTHER "AvKARE, Inc." NITROGLYCERIN 2.5 mg/1
42291-649_949f431e-88fa-2b22-0e04-a27e21b83718 42291-649 HUMAN PRESCRIPTI
ON DRUG Nitroglycerin ER Nitroglycerin CAPSULE ORAL 20121219
UNAPPROVED DRUG OTHER "AvKARE, Inc." NITROGLYCERIN 6.5 mg/1
42291-650_5b385c36-967e-f727-d211-0f20f615117c 42291-650 HUMAN PRESCRIPTI
ON DRUG Norethindrone Acetate Norethindrone TABLET ORAL 20130618
ANDA ANDA200275 "AvKARE, Inc." NORETHINDRONE ACETATE 5 mg/1
42291-651_d5102fe5-d5ac-f335-7783-b60d33a6c88d 42291-651 HUMAN PRESCRIPTI
ON DRUG Nystatin Nystatin "TABLET, FILM COATED" ORAL
20140120 ANDA ANDA062506 "AvKARE, Inc." NYSTATIN
500000 [USP'U]/1 "Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient]
"
42291-652_5a7cc904-7edf-b033-d2f9-b6308899a8cf 42291-652 HUMAN PRESCRIPTI
ON DRUG Olanzapine and Fluoxetine Olanzapine and Fluoxetine
FLUOXETINE HYDROCHLORIDE; OLANZAPINE 25; 3 mg/1; mg/1 "Atypical Antips
ychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [Mo
A]"
A]"
A]"
A]"
A]"
42291-661_bce26ce7-50fa-8ff3-23ba-7360dde69275 42291-661 HUMAN PRESCRIPTI
ON DRUG Oxcarbazepine Oxcarbazepine SUSPENSION ORAL 20140123
ANDA ANDA202961 "AvKARE, Inc." OXCARBAZEPINE 300 mg/5mL "Anti-ep
ivity [PE]"
42291-662_77d29f8f-b000-c7df-512f-6f177d0535b6 42291-662 HUMAN PRESCRIPTI
ON DRUG Oxaprozin Oxaprozin TABLET ORAL 20140306
ANDA ANDA075844 "AvKARE, Inc." OXAPROZIN 600 mg/1 "Cycloox
42291-665_a1c1640a-a19c-bea6-e7c5-9b5b7c3f4c2e 42291-665 HUMAN PRESCRIPTI
20140617 ANDA ANDA076056 "AvKARE, Inc." PRAVASTATIN SODI
42291-670_a26b90d2-4780-47d8-e70c-a6f8b7b633ec 42291-670 HUMAN PRESCRIPTI
20140324 UNAPPROVED DRUG OTHER "AvKARE, Inc." PHENAZOP
YRIDINE HYDROCHLORIDE 100 mg/1
42291-671_a26b90d2-4780-47d8-e70c-a6f8b7b633ec 42291-671 HUMAN PRESCRIPTI
20140324 UNAPPROVED DRUG OTHER "AvKARE, Inc." PHENAZOP
YRIDINE HYDROCHLORIDE 200 mg/1
42291-672_e69a4519-d59d-380c-7da4-0f8389f4ca6e 42291-672 HUMAN PRESCRIPTI
Inc." POTASSIUM CHLORIDE 20 meq/1 "Potassium Compounds [Chemical/I
42291-673_4b9f1cfd-7559-bbcd-1efa-4b3b87ea1d9c 42291-673 HUMAN PRESCRIPTI
ON DRUG POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350
POWDER ORAL 20130705 ANDA ANDA076652 "AvKARE, Inc."
POLYETHYLENE GLYCOL 3350 1 g/g "Osmotic Activity [MoA],Osmotic
Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"
42291-674_c24c87a6-1aba-a9a5-230a-806152eab10b 42291-674 HUMAN PRESCRIPTI
ANDA ANDA074131 "AvKARE, Inc." PIROXICAM 10 mg/1 "Cycloox
42291-677_c24c87a6-1aba-a9a5-230a-806152eab10b 42291-677 HUMAN PRESCRIPTI
ANDA ANDA074131 "AvKARE, Inc." PIROXICAM 20 mg/1 "Cycloox
42291-678_a49f5b38-8759-418c-8c0d-10faebe7264c 42291-678 HUMAN PRESCRIPTI
42291-679_a49f5b38-8759-418c-8c0d-10faebe7264c 42291-679 HUMAN PRESCRIPTI
42291-680_7afc28ec-2843-adcd-127a-228ccfc61330 42291-680 HUMAN PRESCRIPTI
PRAMIPEXOLE DIHYDROCHLORIDE 0.125 mg/1 "Dopamine Agonists [MoA],Nonergo
t Dopamine Agonist [EPC]"
PRAMIPEXOLE DIHYDROCHLORIDE 1 mg/1 "Dopamine Agonists [MoA],Nonergo
42291-685_ca097602-217f-33e1-cb31-1f8fb17f4d24 42291-685 HUMAN PRESCRIPTI
ON DRUG Probenecid and Colchicine Probenecid and Colchicine
COLCHICINE; PROBENECID .5; 500 mg/1; mg/1 "Cytochrome P450 3A4 Inhibitors
[MoA],P-Glycoprotein Interactions [MoA]"
42291-686_711ebe63-51f3-3e71-cb32-e413e1faf11d 42291-686 HUMAN PRESCRIPTI
ON DRUG PRENATAL PLUS "VITAMIN A ACETATE, BETA CAROTENE, ASCORBIC ACID
, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFL
AVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM
CARBONATE, FERROUS FUMARATE, ZINC OXIDE, CUPRIC OXIDE" "TABLET, FILM COATED"
ORAL 20120911 UNAPPROVED DRUG OTHER "AvKARE, Inc."
".ALPHA.-TOCOPHEROL ACETATE, DL-; .BETA.-CAROTENE; ASCORBIC ACID; CALCIUM CARBON
ATE; CHOLECALCIFEROL; CUPRIC OXIDE; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID
; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; VITAM
IN A ACETATE; ZINC OXIDE" 22; 920; 120; 200; 400; 2; 12; 27; 1; 20; 10; 3;
1.84; 3080; 25 mg/1; [iU]/1; mg/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1;
mg/1; mg/1; mg/1; [iU]/1; mg/1 "Vitamin D [Chemical/Ingredient],Vitamin D [EPC]
,Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [
EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Ca
tions, Divalent [Chemical/Ingredient],Vitamin A [Chemical/Ingredient],Vitamin A
[EPC]"
42291-687_b63f5278-d58f-3240-2399-5448a0706b65 42291-687 HUMAN PRESCRIPTI
ON DRUG Pentoxifylline Pentoxifylline "TABLET, EXTENDED RELEASE"
ORAL 20130731 ANDA ANDA075028 "AvKARE, Inc." PENTOXIF
YLLINE 400 mg/1 "Blood Viscosity Reducer [EPC],Hematologic Activity Alte
ration [PE]"
42291-688_7b883565-394b-c20b-cbad-cfe07aa425bd 42291-688 HUMAN PRESCRIPTI
ANDA ANDA200456 "AvKARE, Inc." PROGESTERONE 100 mg/1 "Progest
42291-689_7b883565-394b-c20b-cbad-cfe07aa425bd 42291-689 HUMAN PRESCRIPTI
ANDA ANDA200456 "AvKARE, Inc." PROGESTERONE 200 mg/1 "Progest
42291-693_7a88dcc3-8d44-68e2-9b22-887c6a0afe75 42291-693 HUMAN PRESCRIPTI
ON DRUG Pioglitazone and Metformin Hydrocholride pioglitazone and
metformin hydrochloride "TABLET, FILM COATED" ORAL 20140501
NDA AUTHORIZED GENERIC NDA021842 "AvKARE, Inc." METFORMIN HYDROCHLORIDE;
PIOGLITAZONE HYDROCHLORIDE 500; 15 mg/1; mg/1 "Peroxisome Proliferator
inediones [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient]
"
42291-694_7a88dcc3-8d44-68e2-9b22-887c6a0afe75 42291-694 HUMAN PRESCRIPTI
ON DRUG Pioglitazone and Metformin Hydrocholride pioglitazone and
metformin hydrochloride "TABLET, FILM COATED" ORAL 20140501
NDA AUTHORIZED GENERIC NDA021842 "AvKARE, Inc." METFORMIN HYDROCHLORIDE;
PIOGLITAZONE HYDROCHLORIDE 850; 15 mg/1; mg/1 "Peroxisome Proliferator
inediones [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient]
"
42291-695_34732594-3199-40d9-15fd-8806907b3c88 42291-695 HUMAN PRESCRIPTI
42291-701_ae33cee2-5f21-8ee5-b562-cddb77c436a3 42291-701 HUMAN PRESCRIPTI
ON DRUG Quinapril Quinapril TABLET ORAL 20120802
ANDA ANDA078457 "AvKARE, Inc." QUINAPRIL HYDROCHLORIDE 5 mg/1
ibitors [MoA]"
ibitors [MoA]"
ibitors [MoA]"
ibitors [MoA]"
42291-705_a0a026c2-eb12-9553-dbdc-97e07061f48a 42291-705 HUMAN PRESCRIPTI
hloride and Hydrochlorothiazide TABLET ORAL 20120802 ANDA
ANDA201356 "AvKARE, Inc." HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE
42291-708_d7d5de26-8264-97b7-a352-cd3c19379040 42291-708 HUMAN PRESCRIPTI
ANDA200431 "AvKARE, Inc." ROPINIROLE HYDROCHLORIDE 2 mg/1
42291-713_6df15e58-ed64-edb8-6753-860cb4acdda8 42291-713 HUMAN PRESCRIPTI
42291-718_62289538-5e72-f413-8c60-91b62f521273 42291-718 HUMAN PRESCRIPTI
ANDA ANDA076277 "AvKARE, Inc." RIBAVIRIN 200 mg/1 "Nucleos
ide Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC]"
42291-719_332995b4-b564-94b8-7e36-276441592936 42291-719 HUMAN PRESCRIPTI
ON DRUG REPAGLINIDE repaglinide TABLET ORAL 20131212
ANDA ANDA077571 "AvKARE, Inc." REPAGLINIDE 1 mg/1 "Glinide
[EPC],Potassium Channel Antagonists [MoA]"
42291-720_332995b4-b564-94b8-7e36-276441592936 42291-720 HUMAN PRESCRIPTI
ON DRUG REPAGLINIDE repaglinide TABLET ORAL 20131212
ANDA ANDA077571 "AvKARE, Inc." REPAGLINIDE 2 mg/1 "Glinide
[EPC],Potassium Channel Antagonists [MoA]"
42291-721_d82e3cc9-d539-857d-b4e0-a584503bc403 42291-721 HUMAN PRESCRIPTI
ON DRUG Rabeprazole Sodium Rabeprazole Sodium "TABLET, DELAYED
Inc." RABEPRAZOLE SODIUM 20 mg/1 "Proton Pump Inhibitor [EPC],Pro
42291-722_39b816f4-f4c1-4c2f-77c6-2d444e8b9a10 42291-722 HUMAN PRESCRIPTI
ON DRUG Rabeprazole Sodium Rabeprazole Sodium "TABLET, DELAYED
Inc." RABEPRAZOLE SODIUM 20 mg/1 "Proton Pump Inhibitor [EPC],Pro
42291-723_aeed1cd6-e7f1-8351-cdcd-8691e325b643 42291-723 HUMAN PRESCRIPTI
ON DRUG Riluzole riluzole "TABLET, FILM COATED" ORAL
20140108 NDA AUTHORIZED GENERIC NDA020599 "AvKARE, Inc."
RILUZOLE 50 mg/1 "Benzothiazole [EPC],Benzothiazoles [Chemical/In
gredient]"
42291-724_515fab02-5f08-ae88-06cd-a146e0c1671c 42291-724 HUMAN PRESCRIPTI
ANDA ANDA077824 "AvKARE, Inc." RANITIDINE HYDROCHLORIDE 150
[EPC]"
42291-725_515fab02-5f08-ae88-06cd-a146e0c1671c 42291-725 HUMAN PRESCRIPTI
ANDA ANDA077824 "AvKARE, Inc." RANITIDINE HYDROCHLORIDE 300
[EPC]"
42291-730_32029952-3381-5f32-8178-9e4434957096 42291-730 HUMAN PRESCRIPTI
ON DRUG Sildenafil Sildenafil "TABLET, FILM COATED" ORAL
20130917 ANDA ANDA078380 "AvKARE, Inc." SILDENAFIL CITRA
TE 20 mg/1 "Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5
Inhibitors [MoA]"
42291-750_29ea8356-b95f-8659-0d4a-31cdd577729a 42291-750 HUMAN PRESCRIPTI
ANDA ANDA072710 "AvKARE, Inc." SULINDAC 150 mg/1 "Cycloox
42291-751_29ea8356-b95f-8659-0d4a-31cdd577729a 42291-751 HUMAN PRESCRIPTI
ANDA ANDA072711 "AvKARE, Inc." SULINDAC 200 mg/1 "Cycloox
42291-755_fcc47afc-f65f-6c83-7c4f-a9cb984ab578 42291-755 HUMAN PRESCRIPTI
UNAPPROVED DRUG OTHER "AvKARE, Inc." SALSALATE 500 mg/1
42291-756_fcc47afc-f65f-6c83-7c4f-a9cb984ab578 42291-756 HUMAN PRESCRIPTI
UNAPPROVED DRUG OTHER "AvKARE, Inc." SALSALATE 750 mg/1
42291-757_e91b5106-94a6-e454-b03e-275cc5eaa2be 42291-757 HUMAN PRESCRIPTI
ANDA ANDA070848 "AvKARE, Inc." SUCRALFATE 1 g/1 "Aluminu
m Complex [EPC],Organometallic Compounds [Chemical/Ingredient]"
42291-760_52ad61a0-3d90-3fb6-30d9-b30b9eb496b6 42291-760 HUMAN PRESCRIPTI
20140213 ANDA ANDA076214 "AvKARE, Inc." SOTALOL HYDROCHL
42291-801_6f3e6c8f-9374-de1e-f943-6483c2a1a1c4 42291-801 HUMAN PRESCRIPTI
ON DRUG TERBUTALINE SULFATE TERBUTALINE SULFATE TABLET ORAL
20010626 ANDA ANDA075877 "AvKARE, Inc." TERBUTALINE SULF
ATE 2.5 mg/1
42291-802_6f3e6c8f-9374-de1e-f943-6483c2a1a1c4 42291-802 HUMAN PRESCRIPTI
ON DRUG TERBUTALINE SULFATE TERBUTALINE SULFATE TABLET ORAL
20010626 ANDA ANDA075877 "AvKARE, Inc." TERBUTALINE SULF
ATE 5 mg/1
42291-803_342b8526-6a7a-7313-8ed8-c0fc8fc5f91b 42291-803 HUMAN PRESCRIPTI
ON DRUG Ticlopidine Hydrochloride Ticlopidine Hydrochloride
"AvKARE, Inc." TICLOPIDINE HYDROCHLORIDE 250 mg/1 "Decreased Plate
let Aggregation [PE],Platelet Aggregation Inhibitor [EPC]"
42291-805_43747a98-54a7-0a0d-9c8c-fd117c3b095c 42291-805 HUMAN PRESCRIPTI
ON DRUG Terbinafine Hydrochloride Terbinafine Hydrochloride
TERBINAFINE HYDROCHLORIDE 250 mg/1 "Allylamine [Chemical/Ingredient
],Allylamine Antifungal [EPC]"
42291-810_7a74c21c-593c-c3aa-9f3d-16c338fa86d8 42291-810 HUMAN PRESCRIPTI
68 "AvKARE, Inc." TIZANIDINE HYDROCHLORIDE 2 mg/1 "Adrener
42291-833_885df62e-cfe9-4d0b-80f1-b71d17c8026d 42291-833 HUMAN PRESCRIPTI
20140206 ANDA ANDA071523 "AvKARE, Inc." TRAZODONE HYDROC
42291-837_631f9843-a83a-7002-9a5c-8fdf8de439e2 42291-837 HUMAN PRESCRIPTI
ANDA ANDA077489 "AvKARE, Inc." TRANDOLAPRIL 1 mg/1 "Angiote
[MoA]"
[MoA]"
[MoA]"
42291-840_d7d7c8a6-2a51-600c-ba60-834064dc9c4f 42291-840 HUMAN PRESCRIPTI
ON DRUG Triamcinolone Acetonide Triamcinolone Acetonide PASTE TOPICAL
20120328 ANDA ANDA040771 "AvKARE, Inc." TRIAMCINOLONE AC
ETONIDE 1 mg/g
42291-841_a8d35027-e44e-cd73-2a95-53a026ebc6db 42291-841 HUMAN PRESCRIPTI
orothiazide CAPSULE ORAL 20120703 ANDA ANDA201407
"AvKARE, Inc." HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg
/1 "Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-spa
ring Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [C
42291-845_c6170d17-0d72-3029-7424-04b869a66738 42291-845 HUMAN PRESCRIPTI
ON DRUG Trimethoprim trimethoprim TABLET ORAL 20130506
ANDA ANDA091437 "AvKARE, Inc." TRIMETHOPRIM 100 mg/1 "Dihydro
folate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitor
s [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibi
tors [MoA]"
42291-850_f7b938ac-e2f2-6eee-dfb7-384c5dec8d61 42291-850 HUMAN PRESCRIPTI
ANDA ANDA075517 "AvKARE, Inc." URSODIOL 300 mg/1 "Bile Ac
id [EPC],Bile Acids and Salts [Chemical/Ingredient]"
42291-889_f8ac9647-7644-6520-5147-dc87e2db7b7d 42291-889 HUMAN PRESCRIPTI
"AvKARE, Inc." VALACYCLOVIR HYDROCHLORIDE 1 g/1 "DNA Polymerase
ical/Ingredient]"
42291-892_765fbd6a-3172-a8d1-ff9e-d75bac58a648 42291-892 HUMAN PRESCRIPTI
nhibitors [MoA]"
VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 "Norepinephrine Uptake Inhibitor
nhibitors [MoA]"
nhibitors [MoA]"
nhibitors [MoA]"
nhibitors [MoA]"
42291-897_b9390758-d291-8a10-e1b4-503c236c7cca 42291-897 HUMAN PRESCRIPTI
65 "AvKARE, Inc." VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 "Norepin
65 "AvKARE, Inc." VENLAFAXINE HYDROCHLORIDE 75 mg/1 "Norepin
65 "AvKARE, Inc." VENLAFAXINE HYDROCHLORIDE 150 mg/1 "Norepin
10096-0195_42816e46-aaec-483d-8e12-2a01051bf501 10096-0195 HUMAN OTC DRUG
MARK. Break Out Plan Salicylic Acid GEL TOPICAL 20091229
OTC MONOGRAPH FINAL part333 Avon Products Inc. SALICYLIC ACID 0.75
mL/50mL
10096-0038_568ca901-73be-4fef-a1f3-8d0cc004f79e 10096-0038 HUMAN OTC DRUG
Beyond Color Plumping Lipcolor OCTINOXATE LIPSTICK TOPICAL
20130209 OTC MONOGRAPH NOT FINAL part352 "Avon Products, Inc"
OCTINOXATE 75 mg/g
10096-0071_954c462b-a2ae-4ff7-9c50-92b7d5cc80bd 10096-0071 HUMAN OTC DRUG
Skin So Soft Bug Guard Plus IR3535 Cool N Fabulous Disappearing Color Insec
t Repellent Sunscreen "Octinoxate, Oxybenzone, Octisalate" LOTION TOPICAL
20130212 OTC MONOGRAPH NOT FINAL part352 "Avon Products, Inc"
OCTINOXATE; OCTISALATE; OXYBENZONE 75; 50; 60 mg/mL; mg/mL; mg/mL
10096-0121_3c29d5b3-de93-4d66-9654-14a6a3c3b54a 10096-0121 HUMAN OTC DRUG
Skin So Soft Bug Guard Plus IR3535 Expedition Insect Repellent Sunscreen
"Octocrylene, Octinoxate, Oxybenzone, Octisalate" SPRAY TOPICAL 20130212
OTC MONOGRAPH NOT FINAL part352 "Avon Products, Inc" OCTINOXATE; OCTISALATE;
OCTOCRYLENE; OXYBENZONE 75; 50; 100; 60 mg/mL; mg/mL; mg/mL; mg/mL
10096-0138_68267922-2212-4936-a14d-56ce91851543 10096-0138 HUMAN OTC DRUG
Anew Age-Transforming Concealer "Titanium Dioxide, Octinoxate" CREAM
TOPICAL 20130209 OTC MONOGRAPH NOT FINAL part352 "Avon Products,
Inc" OCTINOXATE; TITANIUM DIOXIDE 25; 66.2 mg/g; mg/g
10096-0149_59ab0592-cb79-434c-83b5-7e41efac7394 10096-0149 HUMAN OTC DRUG
Anew Rejuvenate 24 hour Eye Moisturizer "OCTINOXATE, OCTISALATE, AVOBENZONE, HOM
OSALATE" CREAM TOPICAL 20130208 OTC MONOGRAPH NOT FINAL
part352 "Avon Products, Inc" AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE
10096-0152_898cc617-e642-4d8f-96f5-0eb4c29b503d 10096-0152 HUMAN OTC DRUG
Skin So Soft Bug Guard Plus IR3535 Expedition Insect Repellent Sunscreen
"Octocrylene, Octinoxate, Oxybenzone, Octisalate" AEROSOL TOPICAL 20130212
OCTOCRYLENE; OXYBENZONE 68; 45; 90; 54 mg/g; mg/g; mg/g; mg/g
10096-0158_208d37f0-8214-4aa4-88cb-66d7d40d6350 10096-0158 HUMAN OTC DRUG
Magix Face Perfector "OCTINOXATE, OCTISALATE" LOTION TOPICAL 20120106
OTC MONOGRAPH NOT FINAL part352 "Avon Products, Inc" OCTINOXATE; OCTISALATE
75; 40 mg/mL; mg/mL
10096-0168_084a9c9c-d070-4b8a-a5af-cde88b052bf1 10096-0168 HUMAN OTC DRUG
Solutions A.M. Total Radiance "OCTINOXATE, OCTISALATE, AVOBENZONE"
LOTION TOPICAL 20130208 OTC MONOGRAPH NOT FINAL part352 "Avon Pr
oducts, Inc" AVOBENZONE; OCTINOXATE; OCTISALATE 20; 75; 50 mg/mL; m
g/mL; mg/mL
10096-0171_9554a117-bcb6-4731-ba4f-f162245e5024 10096-0171 HUMAN OTC DRUG
Anew Age-Transforming Foundation "Octinoxate, Titanium Dioxide" LOTION
Inc" OCTINOXATE; TITANIUM DIOXIDE 75; 40 mg/mL; mg/mL
10096-0178_ef0f74ed-7936-4385-ae60-51ab0691f2a6 10096-0178 HUMAN OTC DRUG
Solutions Ageless Results Day "OCTINOXATE, OCTISALATE, OXYBENZONE, AVO
BENZONE" CREAM TOPICAL 20130123 OTC MONOGRAPH NOT FINAL
part352 "Avon Products, Inc" AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE
10096-0181_efa124d3-d775-4ddf-b7ff-1be2581d72c0 10096-0181 HUMAN OTC DRUG
Anew Reversalist Day Renewal "OCTINOXATE, OCTISALATE, OXYBENZONE, AVO
28.5; 71.1; 47.5; 40 mg/g; mg/g; mg/g; mg/g
10096-0189_acb0ee1d-4140-4c73-bba8-0a0dde0e587b 10096-0189 HUMAN OTC DRUG
magix Cashmere Finish Liquid Foundation Titanium Dioxide LOTION
Inc" TITANIUM DIOXIDE 33.9 mg/mL
10096-0257_2626340a-330d-476d-9013-c5518c6a044f 10096-0257 HUMAN OTC DRUG
Ideal Flawless Invisible Coverage Liquid Foundation Titantium Dioxide
oducts, Inc" TITANIUM DIOXIDE 25.8 mg/mL
10096-0284_a63c5612-8ad7-49d0-bea9-57c9a539fd9a 10096-0284 HUMAN OTC DRUG
Footworks Maximum Strength Cracked Heel "Benzalkonium Chloride, Lidocain
e" CREAM TOPICAL 20121016 OTC MONOGRAPH FINAL part348
"Avon Products, Inc" BENZALKONIUM CHLORIDE; LIDOCAINE 1.3; 40 mg/mL; m
g/mL
10096-0285_5de25921-a55a-45d6-9d38-6cad6f03cd85 10096-0285 HUMAN OTC DRUG
Musk Wood Roll-on Anti-perspirant Deodorant Aluminum Chlorohydrate
GEL TOPICAL 20121017 OTC MONOGRAPH FINAL part350 "Avon Pr
oducts, Inc" ALUMINUM CHLOROHYDRATE 145 mg/mL
10096-0286_e3f82075-c54f-4ded-ae1b-562849dba2d0 10096-0286 HUMAN OTC DRUG
Imari Blossom Roll-on Anti-perspirant Deodorant Aluminum Chlorohydrate
10096-0287_a11574ea-99d8-4d38-a125-2299bd950ed1 10096-0287 HUMAN OTC DRUG
Black Suede Essential Roll-on Anti-perspirant Deodorant Aluminum Chloroh
ydrate GEL TOPICAL 20121022 OTC MONOGRAPH FINAL part350
"Avon Products, Inc" ALUMINUM CHLOROHYDRATE 145 mg/mL
10096-0290_bfa767f3-d18c-4cc7-9f85-4dd7a03de331 10096-0290 HUMAN OTC DRUG
Anew Clinical Absolute Even Spot Correcting Hand "OCTINOXATE, OXYBENZONE,
AVOBENZONE" CREAM TOPICAL 20121111 OTC MONOGRAPH NOT FINAL
part352 "Avon Products, Inc" AVOBENZONE; OCTINOXATE; OXYBENZONE 20; 75;
40 mg/g; mg/g; mg/g
10096-0291_9baffd63-26a9-4a6e-8e1b-95b02edba76b 10096-0291 HUMAN OTC DRUG
Moisture Therapy Daily Skin Defense Body "Octinoxate, Octisalate, Oxybenz
"Avon Products, Inc" OCTINOXATE; OCTISALATE; OXYBENZONE 75; 50; 10
mg/mL; mg/mL; mg/mL
10096-0293_054768a6-161b-446a-8e15-d7ea0e5bffe3 10096-0293 HUMAN OTC DRUG
Ideal Flawless Beauty Balm Titantium Dioxide CREAM TOPICAL 20130319
OTC MONOGRAPH NOT FINAL part352 "Avon Products, Inc" TITANIUM DIOXIDE
54 mg/mL
10096-0294_017eb0fc-896b-44a7-998f-d494e7a844e8 10096-0294 HUMAN OTC DRUG
Avon Sun Sunscreen Face "Homosalate, Oxybenzone, Octisalate, Avobenzone,
Octocrylene" LOTION TOPICAL 20130326 OTC MONOGRAPH NOT FINAL
part352 "Avon Products, Inc" AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE;
OXYBENZONE 30; 95; 47.5; 28; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL
10096-0295_b3743844-d6f9-426c-8da5-b459ee6f5fbc 10096-0295 HUMAN OTC DRUG
Avon Sun Sunscreen "Homosalate, Oxybenzone, Octisalate, Avobenzone,
Octocrylene" LOTION TOPICAL 20130326 OTC MONOGRAPH NOT FINAL
part352 "Avon Products, Inc" AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE;
OXYBENZONE 28; 80; 47.5; 25; 47.5 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL
10096-0296_f3887122-2ad3-4d53-b32e-d1ac4842f3d3 10096-0296 HUMAN OTC DRUG
Avon Sun Sunscreen "Homosalate, Octinoxate, Octisalate, Oxybenzone,
Avobenzone, Octocrylene" "AEROSOL, SPRAY" TOPICAL 20130326
OTC MONOGRAPH NOT FINAL part352 "Avon Products, Inc" AVOBENZONE; HOMOSALATE;
OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 28.5; 80; 75; 47.5; 25.6; 47.5
mg/g; mg/g; mg/g; mg/g; mg/g; mg/g
10096-0298_d43b3c91-84e0-44a0-9b88-03e38256b256 10096-0298 HUMAN OTC DRUG
mark Glossworks Lip Gloss "Octinoxate, Avobenzone, Octisalate" LIPSTICK
Inc" AVOBENZONE; OCTINOXATE; OCTISALATE 5; 10; 5 mg/g; mg/g; mg/g
10096-0299_046331da-9e85-4ae5-ae7c-735fe1c2a7ae 10096-0299 HUMAN OTC DRUG
Avon Elements Youth-Restoring Anti-Wrinkle Moisture "Octinoxate, Octisalate,
Oxybenzone, Avobenzone" CREAM TOPICAL 20130401 OTC MONO
GRAPH NOT FINAL part352 "Avon Products, Inc" AVOBENZONE; OCTINOXATE; OCTISALA
TE; OXYBENZONE 20; 71.2; 47.5; 20 mg/mL; mg/mL; mg/mL; mg/mL
10096-0300_96af0372-de4f-4280-aafc-dbfd9dc5b143 10096-0300 HUMAN OTC DRUG
Avon Elements Moisture Boost Daily Moisture "Octinoxate, Octisalate, Avobenz
one" CREAM TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part352
"Avon Products, Inc" AVOBENZONE; OCTINOXATE; OCTISALATE 20; 71.1; 47.5
mg/mL; mg/mL; mg/mL
10096-0301_63304796-84f2-424a-8765-6628e2c18246 10096-0301 HUMAN OTC DRUG
Avon Elements Moisture Boost Daily Moisture "Octinoxate, Octisalate, Avobenz
"Avon Products, Inc" AVOBENZONE; OCTINOXATE; OCTISALATE 28.5; 75; 47.5
mg/mL; mg/mL; mg/mL
10096-0302_32fdc7b7-6e49-43ef-b197-b760d118f4df 10096-0302 HUMAN OTC DRUG
Avon Elements Skin Revitalize Instant Radiance "Octinoxate, Oxybenzone,
Homosalate, Avobenzone" LOTION TOPICAL 20130401 OTC MONO
GRAPH NOT FINAL part352 "Avon Products, Inc" AVOBENZONE; HOMOSALATE; OCTINOXA
TE; OXYBENZONE 25; 30; 75; 35 mg/mL; mg/mL; mg/mL; mg/mL
10096-0305_05085a6a-6871-42c8-a09d-9daa66b996fc 10096-0305 HUMAN OTC DRUG
Anew Rejuvenate Day Revitalizing "OCTINOXATE, OCTISALATE, OXYBENZONE, AVO
30; 75; 50; 47.5 mg/g; mg/g; mg/g; mg/g
10096-0306_05a61449-137e-47c8-88b4-0e1fc0600fac 10096-0306 HUMAN OTC DRUG
Magix Face Perfector "OCTINOXATE, OCTISALATE" LOTION TOPICAL 20130530
OTC MONOGRAPH NOT FINAL part352 "Avon Products, Inc" OCTINOXATE; OCTISALATE
75; 40 mg/mL; mg/mL
10096-0307_12bb9627-403b-479a-84d4-81986a169982 10096-0307 HUMAN OTC DRUG
Ideal Flawless CC Color Corrector "Homosalate, Octinoxate, Oxybenzone, Tit
anium Dioxide, Octocrylene" CREAM TOPICAL 20130906 OTC MONO
GRAPH NOT FINAL part352 "Avon Products, Inc" HOMOSALATE; OCTINOXATE; OCTOCRYL
ENE; OXYBENZONE; TITANIUM DIOXIDE 70; 70; 20; 47; 21.5 mg/mL; mg/mL; mg
/mL; mg/mL; mg/mL
10096-0311_84797fe0-5cc6-4959-b895-037b79bdda1b 10096-0311 HUMAN OTC DRUG
Anew Reversalist Complete Renewal Day "Homosalate, Octinoxate, Oxybenz
one, Avobenzone" LOTION TOPICAL 20131212 OTC MONOGRAPH NO
T FINAL part352 "Avon Products, Inc" AVOBENZONE; HOMOSALATE; OCTINOXATE; OXYB
ENZONE 28.5; 80; 50; 40 mg/mL; mg/mL; mg/mL; mg/mL
10096-0312_2e78d1be-c3b6-4598-bfdf-ec140d4cd470 10096-0312 HUMAN OTC DRUG
Anew Reversalist Complete Renewal Day "Homosalate, Octinoxate, Oxybenz
one, Avobenzone" CREAM TOPICAL 20131212 OTC MONOGRAPH NO
ENZONE 28.5; 70; 70; 40 mg/g; mg/g; mg/g; mg/g
10096-0313_dd2fe6ae-eda2-4277-a609-0d71817216dc 10096-0313 HUMAN OTC DRUG
Avon Sun Sport Refresh Sunscreen "Homosalate, Oxybenzone, Octisalate, Avo
benzone, Octocrylene" LOTION TOPICAL 20131212 OTC MONOGRAPH NO
T FINAL part352 "Avon Products, Inc" AVOBENZONE; HOMOSALATE; OCTISALATE; OCTO
CRYLENE; OXYBENZONE 30; 95; 47.5; 28; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/m
L
10096-0314_96d963ba-bd6f-43d5-a20d-10a868f418d5 10096-0314 HUMAN OTC DRUG
Avon Sun Sport Refresh Sunscreen "Homosalate, Octinoxate, Octisalate, Oxy
benzone, Avobenzone" LOTION TOPICAL 20131212 OTC MONOGRAPH NO
T FINAL part352 "Avon Products, Inc" AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTI
SALATE; OXYBENZONE 30; 80; 75; 47.5; 45 mg/mL; mg/mL; mg/mL; mg/mL; mg/m
L
10096-0315_3d87fa40-6315-4fa9-9674-5c5c60ac6a01 10096-0315 HUMAN OTC DRUG
Avon Sun Sport Refresh Sunscreen "Homosalate, Octinoxate, Oxybenzone, Oct
isalate, Avobenzone" LOTION TOPICAL 20131212 OTC MONOGRAPH NO
T FINAL part352 "Avon Products, Inc" AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTI
SALATE; OXYBENZONE 30; 80; 75; 50; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/m
L
10096-0316_ace216b8-0c37-4564-b7ca-128ff2849ab6 10096-0316 HUMAN OTC DRUG
Ideal Flawless Tinted Moisturizer "Octinoxate, Titanium Dioxide" LOTION
Inc" OCTINOXATE; TITANIUM DIOXIDE 75; 54 mg/mL; mg/mL
10096-0317_99c1329f-cc28-4d52-be21-72c994e45e87 10096-0317 HUMAN OTC DRUG
Skin So Soft DD Body "Octisalate, Oxybenzone, Avobenzone, Octocrylene"
CREAM TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 "Avon Pr
oducts, Inc" AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 28; 47.5; 25; 40
mg/mL; mg/mL; mg/mL; mg/mL
10096-0318_8d706100-41f0-4949-bee1-4f440a49e484 10096-0318 HUMAN OTC DRUG
Avon Elements Youth Restoring Multi-Purpose "Homosalate, Octinoxate, Oxybenz
one, Avobenzone" LOTION TOPICAL 20140317 OTC MONOGRAPH NO
ENZONE 29; 80; 50; 40 mg/mL; mg/mL; mg/mL; mg/mL
10096-0319_ce638796-cd8b-44e8-9be4-60cd354a2c2d 10096-0319 HUMAN OTC DRUG
Avon Vitale Day "Octinoxate, Octisalate, Oxybenzone, Avobenzone"
oducts, Inc" AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 28; 70; 45; 40
mg/g; mg/g; mg/g; mg/g
10096-5214_94767a0b-d968-45e9-8124-45360a31fd43 10096-5214 HUMAN OTC DRUG
Cool Confidence Baby Powder Scent Roll-On Anti-Perspirant Deodorant
Aluminum Chlorohydrate GEL TOPICAL 20121111 OTC MONOGRAPH FI
NAL part350 "Avon Products, Inc" ALUMINUM CHLOROHYDRATE 207 mg/mL
10096-8026_2ac69725-5eea-41bf-9d1a-e24651e76f8c 10096-8026 HUMAN OTC DRUG
Skin So Soft Bug Guard Plus IR3535 Gentle Breeze Insect Repellent Sunscreen
"Octinoxate, Oxybenzone, Octisalate" LOTION TOPICAL 20130212
OXYBENZONE 75; 50; 60 mg/mL; mg/mL; mg/mL
10096-8811_bf7ddce3-df77-4b67-aca8-667b00f4e6cf 10096-8811 HUMAN OTC DRUG
Cool Confidence Original Scent Roll-On Anti-Perspirant Deodorant Aluminum
Chlorohydrate GEL TOPICAL 20121111 OTC MONOGRAPH FINAL
part350 "Avon Products, Inc" ALUMINUM CHLOROHYDRATE 207 mg/mL
10096-9357_f23b7e56-61f6-4104-b8a8-fbf756c80acb 10096-9357 HUMAN OTC DRUG
Sweet Honesty Roll-On Anti-Perspirant Deodorant Aluminum Chlorohydrate
10096-9360_50745553-fe68-4bc8-84e4-341f49f500ba 10096-9360 HUMAN OTC DRUG
Odyssey Roll-On Anti-Perspirant Deodorant Aluminum Chlorohydrate GEL
TOPICAL 20121112 OTC MONOGRAPH FINAL part350 "Avon Products,
Inc" ALUMINUM CHLOROHYDRATE 145 mg/mL
10096-9363_7e6d272f-4f4d-492c-aa14-435babd65b41 10096-9363 HUMAN OTC DRUG
Candid Roll-On Anti-Perspirant Deodorant Aluminum Chlorohydrate GEL
Inc" ALUMINUM CHLOROHYDRATE 145 mg/mL
10096-9468_be557436-2cac-4c31-be10-b720ec0c7a32 10096-9468 HUMAN OTC DRUG
Night Magic Roll-On Anti-Perspirant Deodorant Aluminum Chlorohydrate
10096-9488_71b3b455-5813-4d93-acb0-fd8f80a50730 10096-9488 HUMAN OTC DRUG
Timeless Roll-On Anti-Perspirant Deodorant Aluminum Chlorohydrate
10096-0004_88cc3027-c987-4bb6-8bde-e0266bb26eeb 10096-0004 HUMAN OTC DRUG
foot works arthritis achy foot and muscle Methyl Salicylate CREAM
Inc." METHYL SALICYLATE 18.75 mL/75mL
10096-0081_7adf5769-f5ed-4d2d-86dc-0cdd3e3d8023 10096-0081 HUMAN OTC DRUG
On Duty Original Roll-On Anti-Perspirant Deodorant Aluminum Chloroh
"Avon Products, Inc." ALUMINUM CHLOROHYDRATE 207 mg/mL
10096-0082_5c5e7387-2e56-45bb-b370-3c758c165160 10096-0082 HUMAN OTC DRUG
Feelin Fresh Original Roll-On Anti-Perspirant Deodorant Aluminum Chloroh
10096-0103_4bab55b0-44de-4f98-b2ae-a3ee1ccfc0ee 10096-0103 HUMAN OTC DRUG
moisture therapy intensive healing and repair lip "Octinoxate, Oxy
benzone" OINTMENT TOPICAL 20120522 OTC MONOGRAPH NO
T FINAL part352 "Avon Products, Inc." OCTINOXATE; OXYBENZONE 1.125; .45
mL/15mL; mL/15mL
10096-0144_3bb52643-1d5c-423f-8b4f-b7409f7443b3 10096-0144 HUMAN OTC DRUG
mark. For Gooness Face Antioxidant Skin Moisturizing "Homosalate, Octinoxate,
Octisalate, Oxybenzone, Avobenzone" LOTION TOPICAL 20130308
OTC MONOGRAPH NOT FINAL part352 "Avon Products, Inc." AVOBENZONE; HOMOSALATE;
OCTINOXATE; OCTISALATE; OXYBENZONE 30; 80; 75; 50; 50 mg/mL; mg/mL; mg
/mL; mg/mL; mg/mL
10096-0146_d631b7e3-1a99-4f07-bab8-0aef138ecdc7 10096-0146 HUMAN OTC DRUG
Moisture Therapy Anti-Itch menthol SPRAY TOPICAL 20120926
OTC MONOGRAPH NOT FINAL part348 "Avon Products, Inc." MENTHOL 5 mg/mL
10096-0153_8fd6a82f-087b-4250-9d14-fd2683517241 10096-0153 HUMAN OTC DRUG
Skin So Soft Firm and Restore Age Defying Corrective Neck and Chest "Octinox
ate, Oxybenzone, Octisalate, Avobenzone" CREAM TOPICAL 20120417
OTC MONOGRAPH NOT FINAL part352 "Avon Products, Inc." AVOBENZONE; OCTINOXATE;
OCTISALATE; OXYBENZONE 2; 7.5; 3; 3 mL/100mL; mL/100mL; mL/100mL; mL/100mL
10096-0154_106ec01b-10f1-469e-91db-54c7cd33edeb 10096-0154 HUMAN OTC DRUG
Clearskin Professional Daily Correcting Salicylic Acid LOTION TOPICAL
20111109 OTC MONOGRAPH FINAL part333D "Avon Products,
Inc." SALICYLIC ACID 5 mg/mL
10096-0155_247a0a14-9f9c-4744-ba38-390ca89f761f 10096-0155 HUMAN OTC DRUG
Clearskin Professional Deep Pore Cleansing Scrub Salicylic Acid GEL
TOPICAL 20121111 OTC MONOGRAPH FINAL part333D "Avon Pr
oducts, Inc." SALICYLIC ACID 5 mg/mL
10096-0173_9a4aa372-2642-4132-9024-4cdb368fe869 10096-0173 HUMAN OTC DRUG
mark. get a tint tinted moisturizer "Octinoxate, Titanium Dioxide"
oducts, Inc." OCTINOXATE; TITANIUM DIOXIDE 2.995; 2.905 mL/50mL; mL/50mL
10096-0180_a36f28b1-d9f7-4020-b43f-18e20902e095 10096-0180 HUMAN OTC DRUG
CLEARSKIN PROFESSIONAL INVISIBLE BLEMISH TREATMENT Salicylic Acid GEL
Inc." SALICYLIC ACID 0.3 mL/15mL
10096-0182_dda07418-1783-442b-a9f8-faffd49d867b 10096-0182 HUMAN OTC DRUG
Clearskin Blackhead Eliminating Cleanser Salicylic Acid GEL TOPICAL
20091216 OTC MONOGRAPH FINAL part333 "Avon Products, Inc."
SALICYLIC ACID 2.5 mL/125mL
10096-0183_104763f9-1e49-4be7-8927-300be484023b 10096-0183 HUMAN OTC DRUG
Clearskin Blackhead Eliminating Daily Astringent Salicylic Acid LIQUID
Inc." SALICYLIC ACID 5 mL/250mL
10096-0184_20260945-f4f9-4d13-bdb6-fb56ac8bd40e 10096-0184 HUMAN OTC DRUG
Clearskin Blackhead Eliminating Deep Treatment Mask Salicylic Acid
PASTE TOPICAL 20091216 OTC MONOGRAPH FINAL part333 "Avon Pr
oducts, Inc." SALICYLIC ACID 0.375 mL/75mL
10096-0185_5743e24d-cc10-48e4-af7d-e0bdf7b947b8 10096-0185 HUMAN OTC DRUG
Clearskin Professional Oil Free "OCTINOXATE, OCTISALATE, OXYBENZONE, AVO
BENZONE" LOTION TOPICAL 20091221 OTC MONOGRAPH NOT FINAL
part352 "Avon Products, Inc." AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE
25; 71.1; 45; 30 mg/mL; mg/mL; mg/mL; mg/mL
10096-0186_db8fe33f-1f5a-41d6-8799-1aaf0355ed16 10096-0186 HUMAN OTC DRUG
Clearskin Blemish Clearing Acne Pads Salicylic acid LIQUID TOPICAL
SALICYLIC ACID 300 mg/30g
10096-0188_ae64975b-ac6a-45b7-831c-4c003032bcca 10096-0188 HUMAN OTC DRUG
Ultra Color Rich Mega Impact "OCTINOXATE, OXYBENZONE" LIPSTICK
Inc." OCTINOXATE; OXYBENZONE 150; 90 mg/3g; mg/3g
10096-0191_55c26acc-351a-40d5-b8ab-a80c326a350c 10096-0191 HUMAN OTC DRUG
Ultra Color Rich Cool Bliss OCTINOXATE LIPSTICK TOPICAL
20091229 OTC MONOGRAPH NOT FINAL part352 "Avon Products, Inc."
OCTINOXATE 210 mg/3g
10096-0192_3c8a938b-ce64-4fd7-a955-be6ca9ab0731 10096-0192 HUMAN OTC DRUG
mark. back up plan Anti-Acne Back Treatment Salicylic Acid SPRAY
10096-0193_a4b058f6-4452-4d8c-9819-dc10fff61aef 10096-0193 HUMAN OTC DRUG
True Force Roll-On Antiperspirant Deoderant Aluminum Chlorohydrate
oducts, Inc." ALUMINUM CHLOROHYDRATE 7.25 mL/50mL
10096-0194_37626f3a-17af-4bd3-a3d1-b6d42a05c32f 10096-0194 HUMAN OTC DRUG
MARK. BLEMISH BANISHER Anti-Acne Body Treatment Pads Salicylic Acid CLOTH
10096-0196_0180ddf0-a656-48ab-8a05-46d5203f6049 10096-0196 HUMAN OTC DRUG
Imari Seduction Roll-On Anti-Perspirant Deoderant Aluminum Chlorohydrate
10096-0199_0c26c839-a5d7-4cd7-82d6-7f4675996daf 10096-0199 HUMAN OTC DRUG
Clearskin Pore Penetrating Cleanser TRICLOSAN GEL TOPICAL
TRICLOSAN 0.5 mL/125mL
10096-0200_52d3483c-c276-416f-8229-c3f2f50e2b1d 10096-0200 HUMAN OTC DRUG
Clearskin Blemish Clearing Foaming Cleanser Salicylic acid GEL
10096-0201_1a4c6245-bd7f-450d-8d75-b1cbe2974fec 10096-0201 HUMAN OTC DRUG
mark Totally Balmed "OCTINOXATE, OXYBENZONE, OCTISALATE, AVOBENZONE"
"Avon Products, Inc." AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 84; 294;
199.5; 199.5 mg/4.2g; mg/4.2g; mg/4.2g; mg/4.2g
10096-0203_0f7c7dc1-daf7-4cc0-a875-b26c43056139 10096-0203 HUMAN OTC DRUG
mark. save the day Anti-Acne Concealer Salicylic Acid STICK TOPICAL
Inc." SALICYLIC ACID 36 mg/1.8g
10096-0206_1d0a0ed5-02f6-4d6d-bfb0-a82f805230fb 10096-0206 HUMAN OTC DRUG
Solutions Neck and Chest Perfector "OCTINOXATE, OXYBENZONE, OCTISAL
ATE, AVOBENZONE" CREAM TOPICAL 20100607 OTC MONOGRAPH NO
T FINAL part352 "Avon Products, Inc." AVOBENZONE; OCTINOXATE; OCTISALATE; OXYB
ENZONE 20; 75; 30; 30 mg/mL; mg/mL; mg/mL; mg/mL
10096-0208_b3d50445-ed92-41ea-9d26-1d88ac61fa4a 10096-0208 HUMAN OTC DRUG
Naturals Cucumber and Melon Anti-Bacterial Hand Soap TRICLOSAN
LIQUID TOPICAL 20100609 OTC MONOGRAPH FINAL part333 "Avon Pr
oducts, Inc." TRICLOSAN 0.5 mL/250mL
10096-0209_ff583a28-225c-42a7-82ef-e1b8d2672eb8 10096-0209 HUMAN OTC DRUG
Naturals Pomegranate and Mango Anti-Bacterial Hand Soap TRICLOSAN
LIQUID TOPICAL 20100609 OTC MONOGRAPH NOT FINAL part333 "Avon Pr
oducts, Inc." TRICLOSAN 0.5 mL/250mL
10096-0210_027fb56e-34df-4fd2-b074-f2aac20c7716 10096-0210 HUMAN OTC DRUG
Far Away Dreams Roll-On Antiperspirant Deoderant Aluminum Chlorohydrate
10096-0212_10cbc80c-e5f8-468b-b78a-e6f428eea8ac 10096-0212 HUMAN OTC DRUG
Naturals Antibacterial Liquid Soap Vanilla TRICLOSAN LIQUID
Inc." TRICLOSAN 0.5 mL/250mL
10096-0214_e7e7899a-29af-4410-bfef-a4239477be10 10096-0214 HUMAN OTC DRUG
Healthy Makeup Cream-to-Powder Foundation TITANIUM DIOXIDE CREAM
Inc." TITANIUM DIOXIDE 765 mg/9g
10096-0215_f2550015-df2c-441a-9a5f-be5c70c2a574 10096-0215 HUMAN OTC DRUG
Healthy Makeup Lip Conditioner OCTINOXATE LIPSTICK TOPICAL 20100610
OTC MONOGRAPH NOT FINAL part352 "Avon Products, Inc." OCTINOXATE 225
mg/3g
10096-0216_8ec212b5-92c1-4bda-8ed9-3f5aa44a7dfe 10096-0216 HUMAN OTC DRUG
Healthy Makeup OCTINOXATE LIPSTICK TOPICAL 20100610
OTC MONOGRAPH NOT FINAL part352 "Avon Products, Inc." OCTINOXATE 225
mg/3g
10096-0217_2d7176bc-35f2-4365-9bad-1378673c387f 10096-0217 HUMAN OTC DRUG
Naturals Vanilla Anti-Perspirant Deodorant Aluminum Chlorohydrate
10096-0219_6d951e00-c148-40c6-bdd7-296bdf82a247 10096-0219 HUMAN OTC DRUG
Naturals Cucumber Melon Anti-perspirant Deoderant Aluminum Chloroh
"Avon Products, Inc." ALUMINUM CHLOROHYDRATE 7.25 mL/50mL
10096-0220_001f9823-68ce-4dcb-bc55-603e6f1a7c68 10096-0220 HUMAN OTC DRUG
Advance Techniques Keep Clear Anti-Dandruff Treatment PYRITHIONE ZINC LOTION
Inc." PYRITHIONE ZINC 0.15 mL/150mL
10096-0221_92293452-8e03-4327-a710-75e27a780c26 10096-0221 HUMAN OTC DRUG
Advance Techniques Keep Clear 2-in-1 Anti-Dandruff PYRITHIONE ZINC SHAMPOO
TOPICAL 20100614 OTC MONOGRAPH FINAL part358H "Avon Pr
oducts, Inc." PYRITHIONE ZINC 10 mg/mL
10096-0223_562eb5ea-4da6-4862-bd39-c54ffedbd89e 10096-0223 HUMAN OTC DRUG
Clearskin Blemish Clearing Spot Treatment Salicylic acid GEL TOPICAL
SALICYLIC ACID 0.3 mL/15mL
10096-0224_bf844c3d-e5fc-4583-b582-55c91e2cb187 10096-0224 HUMAN OTC DRUG
ANEW Platinum Day "OCTINOXATE, OCTISALATE, OXYBENZONE, AVOBENZONE"
oducts, Inc." AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 28.5; 75; 47.5;
40 mg/g; mg/g; mg/g; mg/g
10096-0225_c339de63-696d-4977-87fa-7c59f0a56b74 10096-0225 HUMAN OTC DRUG
Rare Diamonds Roll-On Anti-Perspirant Deodorant ALUMINUM CHLOROHYDRATE
10096-0226_4a74b611-6d04-4298-a1ae-22b047488f0f 10096-0226 HUMAN OTC DRUG
Clearskin Professional Clear Pore Thermal Mask Salicylic acid GEL TOPICAL
10096-0227_5889492c-1505-496f-a7e5-cc2759e30be5 10096-0227 HUMAN OTC DRUG
IMARI Mystique Roll-On Anti-Perspirant Deodorant ALUMINUM CHLOROHYDRATE
10096-0228_f292780e-524a-4a00-b306-db9087e7ce83 10096-0228 HUMAN OTC DRUG
Moisture Therapy Ultra Skin Renewal Petrolatum OINTMENT
Inc." PETROLATUM 60.3 mL/100mL
10096-0229_acc165fb-a26e-4db6-99d1-b22b776ed04f 10096-0229 HUMAN OTC DRUG
Ultra Color Rich Moisture Seduction OCTINOXATE LIPSTICK
Inc." OCTINOXATE 0.225 g/3g
10096-0230_49ecd2ac-1a4a-41ae-8deb-f345d148da7b 10096-0230 HUMAN OTC DRUG
Extralasting OCTINOXATE LIPSTICK TOPICAL 20101214
OTC MONOGRAPH NOT FINAL part352 "Avon Products, Inc." OCTINOXATE 0.1125
g/1.5g
10096-0231_b1b7ecd3-cd5e-4412-af47-66dce5bd068f 10096-0231 HUMAN OTC DRUG
Extralasting Cream-to-Powder Foundation "OCTINOXATE, TITANIUM DIOXIDE"
oducts, Inc." OCTINOXATE; TITANIUM DIOXIDE 63.4; 30 mg/g; mg/g
10096-0232_e4e585fb-f89e-47a0-bf16-a820e32d72f4 10096-0232 HUMAN OTC DRUG
Extralasting Liquid Foundation TITANIUM DIOXIDE LOTION TOPICAL
10096-0233_b7b49e60-012e-43f5-8738-aba9a6e11b07 10096-0233 HUMAN OTC DRUG
Musk Marine Roll-On Anti-Perspirant Deodorant ALUMINUM CHLOROHYDRATE
10096-0234_fb5d4ccb-1f32-4cd5-a074-1a0102013e2e 10096-0234 HUMAN OTC DRUG
mark. Get Treatment Anti-Acne Overnight Treatment Salicylic Acid GEL
10096-0236_4ba5c6ef-7bcf-4f7a-ae05-e31da847397b 10096-0236 HUMAN OTC DRUG
mark. Lipclick SPF 15 Color Shine "Octinoxate, Oxybenzone" LIPSTICK
Inc." OCTINOXATE; OXYBENZONE .15; .09 g/3g; g/3g
10096-0237_5f7394a9-b67b-43ec-b132-26d555cab7ce 10096-0237 HUMAN OTC DRUG
mark. Help Wanted Anti-Acne Exfoliating Cleanser Salicylic Acid PASTE
10096-0238_220d4af4-4397-4a95-be8d-5dd7f4fd57bf 10096-0238 HUMAN OTC DRUG
Mommy Tillia Antibacterial Hand ALCOHOL GEL TOPICAL 20101220
OTC MONOGRAPH NOT FINAL part333E "Avon Products, Inc." ALCOHOL 153.34
mL/237mL
10096-0241_cf4480fc-662d-40d3-94d4-e1e50559e63a 10096-0241 HUMAN OTC DRUG
Anew Solar Advance Eye and Lip Sunscreen "TITANIUM DIOXIDE, ZINC OXIDE"
oducts, Inc." TITANIUM DIOXIDE; TITANIUM DIOXIDE; ZINC OXIDE; ZINC OXIDE
.155; .165; .345; .36 g/5g; g/5g; g/5g; g/5g
10096-0242_fe1fdfa1-6cc5-4b17-98f0-5531d1f8ad03 10096-0242 HUMAN OTC DRUG
Tiny Tillia ZINC OXIDE CREAM TOPICAL 20110126
OTC MONOGRAPH FINAL part347 "Avon Products, Inc." ZINC OXIDE 10
g/100g
10096-0243_8caa6ec4-78da-46fe-877b-787623fd7fee 10096-0243 HUMAN OTC DRUG
On Duty 24 Hours Clear Protection Roll-On Anti-Perspirant Deodorant
ALUMINUM ZIRCONIUM PENTACHLOROHYDRATE GEL TOPICAL 20110223
OTC MONOGRAPH FINAL part350 "Avon Products, Inc." ALUMINUM ZIRCONIUM PENTA
CHLOROHYDRATE 5.25 mL/50mL
10096-0249_fb0e485d-e4ce-4d62-b6b2-2454337b11ed 10096-0249 HUMAN OTC DRUG
Moisture Therapy Intensive Healing and Repair Body "OCTINOXATE, OCT
ISALATE, OXYBENZONE" LOTION TOPICAL 20110411 OTC MONOGRAPH NO
T FINAL part352 "Avon Products, Inc." OCTINOXATE; OCTISALATE; OXYBENZONE
10096-0251_087d043b-71e8-4eca-a341-1c15276f128c 10096-0251 HUMAN OTC DRUG
Naturals Vanilla Antibacterial Hand Alcohol GEL TOPICAL 20110414
OTC MONOGRAPH NOT FINAL part333E "Avon Products, Inc." ALCOHOL 19.428
mL/30mL
10096-0252_e6a0e1c1-7f61-4e86-933b-83f89eae93fb 10096-0252 HUMAN OTC DRUG
Naturals Pomegranate and Mango Antibacterial Hand Alcohol GEL
TOPICAL 20110414 OTC MONOGRAPH NOT FINAL part333E "Avon Pr
oducts, Inc." ALCOHOL 19.428 mL/30mL
10096-0253_8ff28e8c-7990-4e14-9ef4-b9e33dcfee03 10096-0253 HUMAN OTC DRUG
Naturals Cucumber Melon Antibacterial Hand Alcohol GEL TOPICAL
20110414 OTC MONOGRAPH NOT FINAL part333E "Avon Products,
Inc." ALCOHOL 19.428 mL/30mL
10096-0254_f5a972d7-1350-4aa1-bf3d-f677a828886d 10096-0254 HUMAN OTC DRUG
ANEW Solar Advance Sunscreen Body Mist "HOMOSALATE, OCTINOXATE, OCTISAL
ATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE" SPRAY TOPICAL 20110411
OTC MONOGRAPH NOT FINAL part352 "Avon Products, Inc." AVOBENZONE; HOMOSALATE;
OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 4.275; 12; 11.25; 7.125; 3.84; 7
.125 mL/150mL; mL/150mL; mL/150mL; mL/150mL; mL/150mL; mL/150mL
10096-0255_cfbc6073-9282-4088-ad2c-dfa027e9568c 10096-0255 HUMAN OTC DRUG
mark. Get Defensive SPF 15 Eye "Octinoxate, Oxybenzone, Octisalate, Avo
benzone" CREAM TOPICAL 20110414 OTC MONOGRAPH NOT FINAL
part352 "Avon Products, Inc." AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE
.3; 1.125; .45; .45 mL/15mL; mL/15mL; mL/15mL; mL/15mL
10096-0258_51a7f2c0-fea0-4432-92a4-717f8e9750cb 10096-0258 HUMAN OTC DRUG
superSHOCK Liquid Lip Shine "OCTINOXATE, OXYBENZONE" LIPSTICK
Inc." OCTINOXATE; OXYBENZONE .525; .315 g/10.5g; g/10.5g
10096-0259_1fd95a73-5901-4928-9269-333dee4cb846 10096-0259 HUMAN OTC DRUG
Musk Fire Roll-On Anti-Perspirant Deodorant ALUMINUM CHLOROHYDRATE
10096-0260_df80c035-9e6a-4179-a110-c7d996a4743b 10096-0260 HUMAN OTC DRUG
Avon Extralasting "Titanium Dioxide, Zinc Oxide" POWDER TOPICAL 20110422
OTC MONOGRAPH NOT FINAL part352 "Avon Products, Inc." TITANIUM DIOXIDE; ZINC O
XIDE .936; .8232 g/12g; g/12g
10096-0261_50030cc2-75cc-4cef-aee9-f8ae31d1da64 10096-0261 HUMAN OTC DRUG
Satin Satisfaction Lip Color OCTINOXATE LIPSTICK TOPICAL
OCTINOXATE 0.28 g/4g
10096-0262_28cc6760-6dee-406a-8573-a4b18e07ca84 10096-0262 HUMAN OTC DRUG
Avon Care Moisture Replenish Daily Hydrating "OCTINOXATE, OXYBENZONE"
oducts, Inc." OCTINOXATE; OXYBENZONE 75; 35 mg/mL; mg/mL
10096-0264_8703eef1-0559-471c-bc70-834965172d13 10096-0264 HUMAN OTC DRUG
Clearskin Professional Acne Mark Treatment Salicylic Acid CREAM TOPICAL
Inc." SALICYLIC ACID 1 mL/50mL
10096-0265_0e22311b-fc82-4244-b50b-5e6335fe8e41 10096-0265 HUMAN OTC DRUG
magiX Illuminating Face Perfector "Octisalate, Titanium Dioxide" CREAM
Inc." OCTISALATE; TITANIUM DIOXIDE .9; .657 mL/30mL; mL/30mL
10096-0266_c9edc5e4-b478-4485-9f95-4c25d44c9720 10096-0266 HUMAN OTC DRUG
Anew Ultimate 7S Day "HOMOSALATE, OCTINOXATE, OXYBENZONE, AVOBENZONE"
oducts, Inc." AVOBENZONE; HOMOSALATE; OCTINOXATE; OXYBENZONE 1.425; 4; 2.5; 2
g/50g; g/50g; g/50g; g/50g
10096-0267_0f737667-a96e-4df2-8cc6-877da00dc01c 10096-0267 HUMAN OTC DRUG
Clearskin Clear Emergency Intensive Treatment Salicylic Acid GEL
oducts, Inc." SALICYLIC ACID 0.022 mL/1.1mL
10096-0268_035929e7-51b8-4100-923c-5e4aac0097d9 10096-0268 HUMAN OTC DRUG
Far Away Roll-On Anti-Perspirant Deodorant ALUMINUM CHLOROHYDRATE
10096-0269_43af9639-455c-4e14-807b-14ae414217cd 10096-0269 HUMAN OTC DRUG
Rare Gold Roll-On Anti-Perspirant Deodorant ALUMINUM CHLOROHYDRATE
10096-0271_d407746d-bc25-474e-b76d-a2068ddad0f1 10096-0271 HUMAN OTC DRUG
Skin So Soft Soft and Sensual Anti-Perspirant Deodorant ALUMINUM ZIRCONI
UM PENTACHLOROHYDRATE GEL TOPICAL 20120402 OTC MONOGRAPH FI
NAL part350 "Avon Products, Inc." ALUMINUM ZIRCONIUM PENTACHLOROHYDRATE
5.25 mL/50mL
10096-0272_7439b818-dab9-499b-ba10-cf698a7fb62b 10096-0272 HUMAN OTC DRUG
Foot Works Healthy Antifungal TOLNAFTATE SPRAY TOPICAL 20111219
OTC MONOGRAPH FINAL part333C "Avon Products, Inc." TOLNAFTATE
1 mL/100mL
10096-0274_3698b595-b61e-46c5-bef5-0f7ccf7d5847 10096-0274 HUMAN OTC DRUG
Skin So Soft Fresh and Smooth Moisturizing Hair Minimizing Anti-Perspirant Deo
dorant aluminum zirconium pentachlorohydrate GEL TOPICAL 20120417
OTC MONOGRAPH FINAL part350 "Avon Products, Inc." ALUMINUM ZIRCONIUM PENTA
CHLOROHYDRATE 5.25 mL/50mL
10096-0275_cb2145c7-ab58-4022-8a16-3d923c1b8c40 10096-0275 HUMAN OTC DRUG
Skin So Soft Original Anti-Perspirant Deodorant aluminum zirconium penta
chlorohydrate GEL TOPICAL 20120417 OTC MONOGRAPH FINAL
part350 "Avon Products, Inc." ALUMINUM ZIRCONIUM PENTACHLOROHYDRATE 5.25
mL/50mL
10096-0276_e55e62c6-811b-4dc8-a62b-5c8ede250f91 10096-0276 HUMAN OTC DRUG
clearskin clear emergency instant spot treatment salicylic acid GEL
10096-0277_7a271cc3-7392-4416-b88f-ff9e889118ae 10096-0277 HUMAN OTC DRUG
clearskin clear emergency intensive cream cleanser salicylic acid
CREAM TOPICAL 20120420 OTC MONOGRAPH FINAL part333D
"Avon Products, Inc." SALICYLIC ACID 1.5 mL/75mL
10096-0278_77bf275b-269e-408c-9f86-9fbd822a3e01 10096-0278 HUMAN OTC DRUG
clearskin blemish clearing 2-in-1 treatment and hydrator salicylic acid
LOTION TOPICAL 20120423 OTC MONOGRAPH FINAL part333D
"Avon Products, Inc." SALICYLIC ACID 0.6 mL/30mL
10096-0279_a128c81e-fae3-4793-bae5-f2d06103dc8d 10096-0279 HUMAN OTC DRUG
ideal flawless invisible coverage cream to powder foundation "Octinoxate, Tit
part352 "Avon Products, Inc." OCTINOXATE; TITANIUM DIOXIDE .568; 30.284
g/9g; g/9g
10096-0280_6ab0343a-eebe-4bb2-894a-93b786782a38 10096-0280 HUMAN OTC DRUG
Ironman Glory Roll-On Anti-Perspirant Deodorant ALUMINUM CHLOROHYDRATE
10096-0281_2ee6e6b4-ff29-4b44-9e09-4b62b0a43626 10096-0281 HUMAN OTC DRUG
mark got the goods multi-benefit foundation "Octinoxate, Titanium Di
oxide, Oxybenzone" LOTION TOPICAL 20120522 OTC MONOGRAPH NO
T FINAL part352 "Avon Products, Inc." OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE
2.247; .6; .78 mL/30mL; mL/30mL; mL/30mL
10096-0282_b601fe98-ecf1-47f4-9c80-1a41555d3b48 10096-0282 HUMAN OTC DRUG
skin so soft bug guard plusitch relief itch relief menthol SPRAY TOPICAL
MENTHOL 5 mg/mL
10096-0288_6c931508-4c34-4f43-8ece-80c11b58d873 10096-0288 HUMAN OTC DRUG
Foot Works Achy Foot Massager Pain Relieving Menthol LOTION TOPICAL
MENTHOL 13.5 mg/mL
10096-0289_1d5b4cb0-0bfb-4dce-bf5a-d29a68b66c5f 10096-0289 HUMAN OTC DRUG
Clearskin Pore Penetrating Cooling Toner Salicylic Acid LIQUID TOPICAL
Inc." SALICYLIC ACID 5 mg/mL
10096-0292_358ea5eb-5b92-4201-8203-d678568bc6b6 10096-0292 HUMAN OTC DRUG
Moisture Therapy Intensive Healing and Repair Skin Protectant Petrolat
um OINTMENT TOPICAL 20100917 OTC MONOGRAPH FINAL
part347 "Avon Products, Inc." PETROLATUM 604 mg/mL
10096-0297_eb1c82ab-fe5d-45a4-82c8-ef4a9940825d 10096-0297 HUMAN OTC DRUG
Clearskin Pore Penetrating Black Mineral Mask Salicylic Acid PASTE
10096-0303_309d35de-58e1-4bda-b228-2b8022d5d1eb 10096-0303 HUMAN OTC DRUG
Foot Works Healthy Antifungal TOLNAFTATE POWDER TOPICAL 20130424
OTC MONOGRAPH FINAL part333C "Avon Products, Inc." TOLNAFTATE
10 mg/g
10096-0304_fac4abc6-c905-4e9f-8cce-a1003152eafe 10096-0304 HUMAN OTC DRUG
Anew Clinical Skinvincible Multi-Shield "Avobenzone, Homosalate, Octinox
ate, Octocrylene, Oxybenzone" LOTION TOPICAL 20130522 OTC MONO
GRAPH NOT FINAL part352 "Avon Products, Inc." AVOBENZONE; HOMOSALATE; OCTINOXA
TE; OCTOCRYLENE; OXYBENZONE 28; 95; 75; 25.6; 47.5 mg/g; mg/g; mg/g; mg/g;
mg/g
10096-0320_94aff49f-669e-4bda-8f08-c3b3fa2558d9 10096-0320 HUMAN OTC DRUG
Clearskin Blackhead Eliminating Daily Astringent Salicylic Acid LIQUID
10096-0868_23294f94-72c5-49e0-960a-96c9f4a927cf 10096-0868 HUMAN OTC DRUG
Haiku Roll-On Anti-Perspirant Deodorant ALUMINUM CHLOROHYDRATE GEL
Inc." ALUMINUM CHLOROHYDRATE 145 mg/mL
10096-4423_d16052fb-5197-4680-b1fa-6dc03084fc53 10096-4423 HUMAN OTC DRUG
Foot Works Cracked Heel "Lidocaine, BENZALKONIUM CHLORIDE" CREAM
Inc." BENZALKONIUM CHLORIDE; LIDOCAINE .065; 1 mL/50mL; mL/50mL
10096-5218_38051f60-a213-46e0-afa6-c4344579fb1d 10096-5218 HUMAN OTC DRUG
On Duty Sport Roll-On Anti-Perspirant Deodorant Aluminum Chlorohydrate
oducts, Inc." ALUMINUM CHLOROHYDRATE 207 mg/mL
10096-5219_0487efdf-515c-4218-9ff8-6375b94faa4e 10096-5219 HUMAN OTC DRUG
On Duty Unscented Roll-On Anti-Perspirant Deodorant Aluminum Chloroh
10096-7817_a498e3dc-48cf-4610-a1b2-4c3ae862e938 10096-7817 HUMAN OTC DRUG
Mesmerize for Men Roll-On Anti-Perspirant Deodorant ALUMINUM CHLOROH
YDRATE GEL TOPICAL 20121114 OTC MONOGRAPH FINAL part350
10096-9182_0908721e-3ab8-42b4-a312-cb5bff4e11a4 10096-9182 HUMAN OTC DRUG
Black Suede Roll-On Anti-Perspirant Deodorant ALUMINUM CHLOROHYDRATE
10096-9298_a7e5307b-ce64-43ee-aa1c-432dd6be8a9c 10096-9298 HUMAN OTC DRUG
Wild Country Roll-On Anti-Perspirant Deodorant ALUMINUM CHLOROHYDRATE
oducts, Inc." ALUMINUM CHLOROHYDRATE 145 mg/mL
10096-9475_8cd01933-7003-41c7-a60d-5d3b25044a5a 10096-9475 HUMAN OTC DRUG
Imari Roll-On Anti-Perspirant Deodorant ALUMINUM CHLOROHYDRATE GEL
Inc." ALUMINUM CHLOROHYDRATE 145 mg/mL
50268-050_a0366c51-a4df-41f9-884a-16a3adbf3d33 50268-050 HUMAN PRESCRIPTI
CAPSULE ORAL 20091201 ANDA ANDA075047 AvPAK ACEBUTOL
OL HYDROCHLORIDE 200 mg/1 "Adrenergic beta-Antagonists [MoA],beta-
50268-051_a0366c51-a4df-41f9-884a-16a3adbf3d33 50268-051 HUMAN PRESCRIPTI
CAPSULE ORAL 20091201 ANDA ANDA075047 AvPAK ACEBUTOL
OL HYDROCHLORIDE 400 mg/1 "Adrenergic beta-Antagonists [MoA],beta-
50268-060_a016a66e-6e17-b5f4-efd1-bb7f210c1035 50268-060 HUMAN PRESCRIPTI
ANDA ANDA075090 AvPAK ACYCLOVIR 200 mg/1 "DNA Polymerase
ical/Ingredient]"
50268-061_9291464f-8de8-f4c2-5935-6b868393df82 50268-061 HUMAN PRESCRIPTI
ical/Ingredient]"
50268-062_9291464f-8de8-f4c2-5935-6b868393df82 50268-062 HUMAN PRESCRIPTI
ical/Ingredient]"
50268-069_ea5236cf-1e6b-c0fa-8660-7dae1c92cf2d 50268-069 HUMAN PRESCRIPTI
FILLED" ORAL 20140328 ANDA ANDA078720 AvPAK
AMANTADINE HYDROCHLORIDE 100 mg/1 "Influenza A M2 Protein Inhibito
r [EPC],M2 Protein Inhibitors [MoA]"
50268-071_4f527fd7-3305-3fab-903f-9312b9530933 50268-071 HUMAN PRESCRIPTI
ON DRUG Amiloride Hydrochloride Amiloride Hydrochloride TABLET ORAL
20130128 ANDA ANDA079133 AvPAK AMILORIDE HYDROCHLORIDE
5 mg/1 "Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potas
sium-sparing Diuretic [EPC]"
50268-081_60c28d7b-81c1-c346-e270-d8d925e67185 50268-081 HUMAN PRESCRIPTI
20110607 ANDA ANDA078500 AvPAK AMLODIPINE BESYLATE
50268-082_60c28d7b-81c1-c346-e270-d8d925e67185 50268-082 HUMAN PRESCRIPTI
50268-083_873cafe3-eec0-5298-e8b4-cdaf23b30eed 50268-083 HUMAN PRESCRIPTI
2.5 mg/1 "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Chann
50268-098_4a732052-d310-4e2a-9456-f1bab2eb072b 50268-098 HUMAN PRESCRIPTI
20110520 ANDA ANDA065404 AvPAK AZITHROMYCIN ANHYDROUS
250 mg/1 "Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]"
50268-099_4a732052-d310-4e2a-9456-f1bab2eb072b 50268-099 HUMAN PRESCRIPTI
20110520 ANDA ANDA065405 AvPAK AZITHROMYCIN ANHYDROUS
500 mg/1 "Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]"
50268-100_e6a2f20f-b7b1-9833-a7df-6c4b14b236d3 50268-100 HUMAN PRESCRIPTI
ORAL 20140326 ANDA ANDA065507 AvPAK AZITHROMYCIN DIH
YDRATE 250 mg/1 "Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingr
edient]"
50268-101_e6a2f20f-b7b1-9833-a7df-6c4b14b236d3 50268-101 HUMAN PRESCRIPTI
ORAL 20140326 ANDA ANDA065509 AvPAK AZITHROMYCIN DIH
YDRATE 500 mg/1 "Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingr
edient]"
50268-109_8ce04631-06e6-43c1-bb97-4d3ac0dc94e2 50268-109 HUMAN PRESCRIPTI
TABLET ORAL 20140414 ANDA ANDA076820 AvPAK BENAZEPR
IL HYDROCHLORIDE 5 mg/1 "Angiotensin Converting Enzyme Inhibitor
PE]"
PE]"
PE]"
PE]"
50268-113_ec2fc547-9c81-d537-7ead-525c25a813eb 50268-113 HUMAN PRESCRIPTI
20070111 ANDA ANDA040855 AvPAK BETHANECHOL CHLORIDE
10 mg/1 "Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Ago
nists [MoA]"
50268-114_ec2fc547-9c81-d537-7ead-525c25a813eb 50268-114 HUMAN PRESCRIPTI
20070111 ANDA ANDA040855 AvPAK BETHANECHOL CHLORIDE
25 mg/1 "Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Ago
nists [MoA]"
50268-180_3cd71b92-ff14-6e3e-a03a-8df5f650d64e 50268-180 HUMAN PRESCRIPTI
CAPSULE ORAL 20140715 ANDA ANDA065442 AvPAK CLINDAMY
CIN HYDROCHLORIDE 150 mg/1 "Decreased Sebaceous Gland Activity [PE]
50268-181_3cd71b92-ff14-6e3e-a03a-8df5f650d64e 50268-181 HUMAN PRESCRIPTI
CAPSULE ORAL 20140715 ANDA ANDA065442 AvPAK CLINDAMY
CIN HYDROCHLORIDE 300 mg/1 "Decreased Sebaceous Gland Activity [PE]
50268-190_d41ef46c-d179-308d-ea0d-61ac23994c47 50268-190 HUMAN PRESCRIPTI
TABLET ORAL 20140610 ANDA ANDA090478 AvPAK CYCLOBEN
ZAPRINE HYDROCHLORIDE 5 mg/1 "Centrally-mediated Muscle Relaxation [P
E],Muscle Relaxant [EPC]"
50268-219_6bdcdbf8-824a-fbfe-c02c-823d6a9f1435 50268-219 HUMAN PRESCRIPTI
ON DRUG Desloratadine Desloratadine TABLET ORAL 20131009
ANDA ANDA078355 AvPAK DESLORATADINE 5 mg/1 "Histamine H1 Re
50268-220_d4e54f76-7fb7-147e-f6df-872959f963e4 50268-220 HUMAN PRESCRIPTI
20130724 ANDA ANDA076470 AvPAK DESMOPRESSIN ACETATE
0.1 mg/1 "Factor VIII Activator [EPC],Increased Coagulation Factor VIII A
ctivity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin An
alog [EPC],Vasopressins [Chemical/Ingredient]"
50268-221_d4e54f76-7fb7-147e-f6df-872959f963e4 50268-221 HUMAN PRESCRIPTI
20130724 ANDA ANDA076470 AvPAK DESMOPRESSIN ACETATE
0.2 mg/1 "Factor VIII Activator [EPC],Increased Coagulation Factor VIII A
ctivity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin An
alog [EPC],Vasopressins [Chemical/Ingredient]"
50268-263_82103525-ffe6-da9c-8c10-c6a5dd52d381 50268-263 HUMAN PRESCRIPTI
20070805 ANDA ANDA040782 AvPAK DIPYRIDAMOLE 25
mg/1 "Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC
]"
]"
]"
50268-277_c39034b8-7a3e-bb42-3614-55ac6ab7f5c1 50268-277 HUMAN PRESCRIPTI
20140605 ANDA ANDA062675 AvPAK DOXYCYCLINE HYCLATE
50 mg/1
20140605 ANDA ANDA062676 AvPAK DOXYCYCLINE HYCLATE
100 mg/1
ATED" ORAL 20140605 ANDA ANDA062677 AvPAK DOXYCYCL
INE HYCLATE 100 mg/1
50268-290_c4773979-61dd-55b2-cac4-1f2e1d3eb970 50268-290 HUMAN PRESCRIPTI
ANDA ANDA040114 AvPAK ESTRADIOL 0.5 mg/1 "Estradiol Conge
ners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA]"
ANDA ANDA040114 AvPAK ESTRADIOL 1 mg/1 "Estradiol Conge
ANDA ANDA040114 AvPAK ESTRADIOL 2 mg/1 "Estradiol Conge
50268-305_e9599667-3467-b994-9693-50f367fc9355 50268-305 HUMAN PRESCRIPTI
20130516 ANDA ANDA201022 AvPAK FAMCICLOVIR 125
mg/1 "DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polym
erase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient]"
50268-323_cffb3f72-cf7c-f60c-2d4b-5a32504f9763 50268-323 HUMAN PRESCRIPTI
20070328 ANDA ANDA077914 AvPAK FINASTERIDE 5
mg/1 "5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA]"
50268-324_8a250c3e-0891-70fb-d96c-a97211937eb7 50268-324 HUMAN PRESCRIPTI
ON DRUG Flavoxate Hydrochloride Flavoxate Hydrochloride TABLET ORAL
20121130 ANDA ANDA076835 AvPAK FLAVOXATE HYDROCHLORIDE
100 mg/1 "Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic
Antagonists [MoA]"
50268-330_d5e2c519-1a7e-4f43-a530-9e1e297a8f26 50268-330 HUMAN PRESCRIPTI
ON DRUG FLUDROCORTISONE ACETATE FLUDROCORTISONE ACETATE TABLET ORAL
20110801 ANDA ANDA040431 AvPAK FLUDROCORTISONE ACETATE
0.1 mg/1
50268-333_0318a17c-c202-dfe0-19f1-d01a77db9ff0 50268-333 HUMAN PRESCRIPTI
20140820 ANDA ANDA078619 AvPAK FLUOXETINE HYDROCHLORIDE
[MoA]"
[MoA]"
[MoA]"
50268-345_0a34d7e5-8c2b-27ac-0aa5-99feaf5a2c46 50268-345 HUMAN PRESCRIPTI
ANDA ANDA040625 AvPAK FOLIC ACID 1 mg/1
50268-350_2836c7d7-d81b-c80e-c6b3-ab75bb808300 50268-350 HUMAN PRESCRIPTI
ON DRUG Gemfibrozil Gemfibrozil TABLET ORAL 20140710
ANDA ANDA077836 AvPAK GEMFIBROZIL 600 mg/1 "Peroxisome Prol
iferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor
alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient]"
50268-403_8663aadc-13e5-6df8-bd0f-86f2d56c7aa5 50268-403 HUMAN PRESCRIPTI
ANDA040736 AvPAK ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg
50268-408_8663aadc-13e5-6df8-bd0f-86f2d56c7aa5 50268-408 HUMAN PRESCRIPTI
ANDA040746 AvPAK ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg
50268-451_7187651c-694f-c2c7-cad0-d3ff9c8cc3bc 50268-451 HUMAN PRESCRIPTI
D RELEASE" ORAL 20121213 ANDA ANDA075155 AvPAK
ISOSORBIDE MONONITRATE 30 mg/1 "Nitrate Vasodilator [EPC],Nitrates [Che
50268-454_712e3391-0c2e-860b-6c66-e79ca531ac2e 50268-454 HUMAN PRESCRIPTI
ON DRUG Isradipine Isradipine CAPSULE ORAL 20140106
ANDA ANDA077317 AvPAK ISRADIPINE 2.5 mg/1 "Calcium Channel
50268-455_712e3391-0c2e-860b-6c66-e79ca531ac2e 50268-455 HUMAN PRESCRIPTI
ON DRUG Isradipine Isradipine CAPSULE ORAL 20140106
ANDA ANDA077317 AvPAK ISRADIPINE 5 mg/1 "Calcium Channel
50268-467_f4344183-213a-5c02-f491-533c0bd4b8fa 50268-467 HUMAN PRESCRIPTI
20090320 ANDA ANDA077319 AvPAK LEVETIRACETAM 250
50268-507_eb5e64c8-1009-ae6e-75a3-a9b78a044719 50268-507 HUMAN PRESCRIPTI
ANDA ANDA071403 AvPAK LORAZEPAM 0.5 mg/1 "Benzodiazepine
ANDA ANDA071404 AvPAK LORAZEPAM 1 mg/1 "Benzodiazepine
ANDA ANDA071141 AvPAK LORAZEPAM 2 mg/1 "Benzodiazepine
50268-510_990ed216-ebfb-0cb3-1405-94e125ee94b7 50268-510 HUMAN PRESCRIPTI
ANDA ANDA075991 AvPAK LOVASTATIN 10 mg/1 "HMG-CoA Reducta
50268-513_df00865c-a001-fd18-78c9-080866d8e381 50268-513 HUMAN PRESCRIPTI
ANDA090528 AvPAK HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 50
ical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor
Blocker [EPC]"
ANDA090528 AvPAK HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 100
ical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor
Blocker [EPC]"
ANDA090528 AvPAK HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25; 100 mg/1; mg
redient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker
[EPC]"
50268-516_178dc4dd-bf29-7b2c-5d90-c4c4e1661504 50268-516 HUMAN PRESCRIPTI
ON DRUG Losartan Potassium Losartan Potassium TABLET ORAL
20140327 ANDA ANDA090467 AvPAK LOSARTAN POTASSIUM
Blocker [EPC]"
Blocker [EPC]"
Blocker [EPC]"
50268-522_cc50d3bc-4e27-59b2-c0ca-e00564476650 50268-522 HUMAN PRESCRIPTI
ANDA ANDA201451 AvPAK MECLIZINE HYDROCHLORIDE 12.5 mg/1 "Antieme
tic [EPC],Emesis Suppression [PE]"
50268-523_cc50d3bc-4e27-59b2-c0ca-e00564476650 50268-523 HUMAN PRESCRIPTI
20130808 ANDA ANDA201451 AvPAK MECLIZINE HYDROCHLORIDE
25 mg/1 "Antiemetic [EPC],Emesis Suppression [PE]"
50268-525_0f51c482-fe39-f853-8056-298147c08151 50268-525 HUMAN PRESCRIPTI
ANDA ANDA077918 AvPAK MELOXICAM 7.5 mg/1 "Cyclooxygenase
50268-526_0f51c482-fe39-f853-8056-298147c08151 50268-526 HUMAN PRESCRIPTI
ANDA ANDA077918 AvPAK MELOXICAM 15 mg/1 "Cyclooxygenase
50268-531_e87b7920-3b69-408f-8249-8428e384f95f 50268-531 HUMAN PRESCRIPTI
gredient]"
50268-564_d6d6d331-54c2-5b49-0d83-ec7f876c1cb3 50268-564 HUMAN PRESCRIPTI
20110817 ANDA ANDA076449 AvPAK MIDODRINE HYDROCHLORIDE
2.5 mg/1 "Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC]"
50268-592_b9512adc-596f-6c27-12e1-61b6824be793 50268-592 HUMAN PRESCRIPTI
ANDA ANDA078432 AvPAK NAPROXEN SODIUM 275 mg/1 "Cyclooxygenase
50268-593_b9512adc-596f-6c27-12e1-61b6824be793 50268-593 HUMAN PRESCRIPTI
ANDA ANDA078432 AvPAK NAPROXEN SODIUM 550 mg/1 "Cyclooxygenase
50268-597_2ba32422-7607-0455-aff1-be65e104b5d8 50268-597 HUMAN PRESCRIPTI
ON DRUG Nifedipine ER Nifedipine "TABLET, FILM COATED, EXTENDED R
ELEASE" ORAL 20051121 ANDA ANDA077127 AvPAK NIFEDIPI
50268-615_445ebaf7-7c96-ad25-d622-a3772b000356 50268-615 HUMAN PRESCRIPTI
ORAL 20140417 ANDA ANDA091415 AvPAK OLANZAPINE
50268-619_6208ef51-7581-b590-159d-9904e1f9ff6e 50268-619 HUMAN PRESCRIPTI
ORAL 20110711 ANDA ANDA075410 AvPAK OMEPRAZOLE
50268-620_6208ef51-7581-b590-159d-9904e1f9ff6e 50268-620 HUMAN PRESCRIPTI
ORAL 20110711 ANDA ANDA075410 AvPAK OMEPRAZOLE
50268-627_b8291e8c-9375-ac6f-9679-48a06552349c 50268-627 HUMAN PRESCRIPTI
03 AvPAK OXYBUTYNIN CHLORIDE 5 mg/1 "Cholinergic Muscarinic
50268-636_a04e7140-cc30-6b45-7ecd-747a842d7ab1 50268-636 HUMAN PRESCRIPTI
RELEASE" ORAL 20130115 ANDA ANDA078281 AvPAK
PANTOPRAZOLE SODIUM 20 mg/1 "Proton Pump Inhibitor [EPC],Proton Pump
Inhibitors [MoA]"
50268-637_a04e7140-cc30-6b45-7ecd-747a842d7ab1 50268-637 HUMAN PRESCRIPTI
RELEASE" ORAL 20130115 ANDA ANDA078281 AvPAK
PANTOPRAZOLE SODIUM 40 mg/1 "Proton Pump Inhibitor [EPC],Proton Pump
Inhibitors [MoA]"
50268-660_8d3a0d01-0b12-4cbc-81c9-5c1708188b53 50268-660 HUMAN PRESCRIPTI
ON DRUG Phenytoin Sodium Extended Phenytoin Sodium CAPSULE
ORAL 20091216 ANDA ANDA040765 AvPAK PHENYTOIN SODIUM
50268-686_bc04785c-cc07-a9df-3a60-e8bac55b4341 50268-686 HUMAN PRESCRIPTI
ANDA ANDA040866 AvPAK PRIMIDONE 50 mg/1 "Anti-epileptic
E]"
50268-687_bc04785c-cc07-a9df-3a60-e8bac55b4341 50268-687 HUMAN PRESCRIPTI
ANDA ANDA040866 AvPAK PRIMIDONE 250 mg/1 "Anti-epileptic
E]"
50268-688_5d04ab43-8d00-9421-b0bd-2068ea8e7f58 50268-688 HUMAN PRESCRIPTI
ANDA ANDA078457 AvPAK QUINAPRIL HYDROCHLORIDE 5 mg/1 "Angiote
[MoA]"
[MoA]"
[MoA]"
[MoA]"
50268-695_bd76ffea-20b6-6235-7fc6-0e4ec7a2a7df 50268-695 HUMAN PRESCRIPTI
20140827 ANDA ANDA078040 AvPAK RISPERIDONE 0.5
20140827 ANDA ANDA078040 AvPAK RISPERIDONE 1
50268-726_66e609a0-e5d6-7323-712f-a96a48e0d3ba 50268-726 HUMAN PRESCRIPTI
ANDA ANDA040353 AvPAK SPIRONOLACTONE 25 mg/1 "Aldosterone Ant
agonist [EPC],Aldosterone Antagonists [MoA]"
50268-730_7ac1cc37-239b-4fb8-8b30-de00f3e2dea5 50268-730 HUMAN PRESCRIPTI
ON DRUG Sulfasalazine Sulfasalazine TABLET ORAL 20140114
ANDA ANDA085828 AvPAK SULFASALAZINE 500 mg/1 "Aminosalicylate
[EPC],Aminosalicylic Acids [Chemical/Ingredient]"
50268-775_dc969c1e-2211-3ad1-7591-1dcfa3aa2137 50268-775 HUMAN PRESCRIPTI
ON DRUG Trimethoprim Trimethoprim TABLET ORAL 20130731
ANDA ANDA070049 AvPAK TRIMETHOPRIM 100 mg/1 "Dihydrofolate R
eductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],
Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [Mo
A]"
50268-795_541a38e3-557f-48cf-8126-8f5a75e76052 50268-795 HUMAN PRESCRIPTI
ANDA ANDA079082 AvPAK URSODIOL 300 mg/1 "Bile Acid [EPC]
,Bile Acids and Salts [Chemical/Ingredient]"
50268-796_4247144b-c92d-9838-0988-2c190f6911b5 50268-796 HUMAN PRESCRIPTI
ANDA ANDA075517 AvPAK URSODIOL 300 mg/1 "Bile Acid [EPC]
,Bile Acids and Salts [Chemical/Ingredient]"
50268-815_9ba8ec81-8237-51d9-d6a2-0aa876c6edef 50268-815 HUMAN PRESCRIPTI
ANDA ANDA077636 AvPAK ZONISAMIDE 100 mg/1 "Anti-epileptic
E]"
50268-816_c60a35d3-a60c-3686-586d-cbb30ecc7298 50268-816 HUMAN PRESCRIPTI
ANDA ANDA077869 AvPAK ZONISAMIDE 100 mg/1 "Anti-epileptic
E]"
42891-4148_7ae69b69-b35d-4ddc-b416-ead4afea86ce 42891-4148 HUMAN OTC DRUG
AVVA Benzalkonium chloride GEL VAGINAL 20120328
OTC MONOGRAPH NOT FINAL part333A AVVA International LLC BENZALKONIUM CHL
ORIDE 100 mg/100mL
59387-001_cdf14795-54e6-4ed4-a8f5-7163cb1a1f1d 59387-001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS "A-Welders and Medical Supply, Inc" OXYGEN
99 L/100L
59387-002_e3db1d0b-f0d0-41d4-b6d2-2f8235cf8cac 59387-002 HUMAN PRESCRIPTI
19800101 UNAPPROVED MEDICAL GAS "A-Welders and Medical S
upply, Inc" NITROGEN 99 L/100L
17819-1066_161bfcfa-e32b-487b-944b-16f60b7de25c 17819-1066 HUMAN PRESCRIPTI
19870101 UNAPPROVED MEDICAL GAS AWESCO NITROGEN
99 L/100L
49743-3047_d763cf0b-a67f-490c-852d-ce795fa6e62f 49743-3047 HUMAN OTC DRUG
"Mineral Oil, Petrolatum and Phenylephrine HCl" "mineral oil, petrolatum
, phenylephrine HCl" OINTMENT TOPICAL 20130628 OTC MONO
GRAPH FINAL part346 "Axcentria Pharmaceuticals, LLC" MINERAL OIL; PET
ROLATUM; PHENYLEPHRINE HYDROCHLORIDE 140; 741; 2.5 mg/g; mg/g; mg/g
49743-3001_7da063a7-3c4f-4626-b1c9-70bfd6488314 49743-3001 HUMAN OTC DRUG
SelectHealth Tussin DM Guaifenesin LIQUID ORAL 20110901
OTC MONOGRAPH FINAL part341 "Axcentria Pharmaceuticals, LLC." GUAIFENE
SIN 100 mg/5mL
49743-3003_dfcebe7c-7215-47cf-9e2c-9822439eb207 49743-3003 HUMAN OTC DRUG
Select Health Allergy Relief Cherry Diphenhydramine Hydrochloride LIQUID
ORAL 20110901 OTC MONOGRAPH FINAL part341 "Axcentria Pharm
aceuticals, LLC." DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL
59246-0001_f2cd1e05-f678-4d77-9d70-959f321e340f 59246-0001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS A-Z HME Inc OXYGEN 99 L/100L
75887-001_c434da1f-1978-4fb1-a3c2-6cfc97ceb191 75887-001 HUMAN OTC DRUG
Hand Sanitizer Anticeptic ALCOHOL GEL TOPICAL 20110118
OTC MONOGRAPH NOT FINAL part333A Aztex Enterprises ALCOHOL 5
mL/8mL
75887-002_b04a8c62-4b69-43d1-8429-1531c35076df 75887-002 HUMAN OTC DRUG
Lip Balm Unflavored "Octinoxate, Octisalate, Oxybenzone" STICK
TOPICAL 20110118 OTC MONOGRAPH NOT FINAL part352 Aztex Enterprise
s OCTINOXATE; OCTISALATE; OXYBENZONE .3; .08; .13 g/4.2g; g/4.2g;
g/4.2g
75887-003_1a05b791-a0ae-48b3-a951-b6928d0bfa44 75887-003 HUMAN OTC DRUG
Sunscreen 30 SPF "OCTINOXATE, OXYBENZONE" LOTION TOPICAL 20110118
OTC MONOGRAPH NOT FINAL part352 Aztex Enterprises OCTINOXATE; OXYBENZONE
22; 16 mL/30mL; mL/30mL
18860-852_06b963be-0817-469e-ad3a-8096324fbe94 18860-852 HUMAN PRESCRIPTI
ON DRUG Natelle One Natelle One "CAPSULE, GELATIN COATED"
ORAL 20091109 UNAPPROVED DRUG OTHER na "Azur Pharma, In
c." "ALPHA-TOCOPHEROL, D-; ASCORBIC ACID; DOCONEXENT; FERROUS FUMARATE; FOLI
C ACID; ICOSAPENT; PYRIDOXINE HYDROCHLORIDE; TRICALCIUM PHOSPHATE" 30; 30;
250; 27; 1; .625; 25; 100 [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1
"Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Ch
elating Activity [MoA]"
53083-001_c5d56da7-e6dc-4fa8-891b-4ebe48d8fb91 53083-001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS "B & R Welder Repair Service, Inc" OXYGEN
995 mL/L
67573-0101_bfadc1ca-4577-4a92-97b8-c4c71ac14002 67573-0101 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS B&J Welding Supply LTD OXYGEN 99.5 L/100L
54300-0001_6e83dce7-81fd-422e-8c9c-90e9c73e2693 54300-0001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS "B&K Home Medical Services, Inc." OXYGEN
99 L/100L
62741-0123_342e85ec-7690-4a92-af22-e6bc12a536f9 62741-0123 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS B&K Prescription Shop OXYGEN 99 L/100L
76482-013_2deddc27-52fd-4021-bb95-36862e4dfc22 76482-013 HUMAN OTC DRUG
LEudine Anti-dandruff Pyrithione Zinc SHAMPOO TOPICAL 20130401
OTC MONOGRAPH FINAL part358H B&R Products Inc PYRITHIONE ZINC
1 g/100mL
0264-1101_9925a78e-b022-4114-b7a3-55337179ae88 0264-1101 HUMAN PRESCRIPTI
ON DRUG Dextrose DEXTROSE "INJECTION, SOLUTION" INTRAVEN
OUS 20110727 20150101 UNAPPROVED DRUG OTHER B. Braun
Medical Inc. DEXTROSE 5 g/100mL
0264-1290_2e0e3715-ffd6-4f3c-b61d-f6f27b1d43ea 0264-1290 HUMAN PRESCRIPTI
OUS 20120313 UNAPPROVED DRUG OTHER B. Braun Medical
Inc. DEXTROSE MONOHYDRATE 70 g/100mL
0264-1510_e2335516-28c6-449a-871d-747350f5edf9 0264-1510 HUMAN PRESCRIPTI
ON DRUG Dextrose Dextrose "INJECTION, SOLUTION" INTRAVEN
OUS 19731221 NDA NDA016730 B. Braun Medical Inc.
DEXTROSE MONOHYDRATE 50 mg/mL
0264-1800_4bf22bed-d1d8-41e1-a62a-fba940fd34a8 0264-1800 HUMAN PRESCRIPTI
SODIUM CHLORIDE 9 mg/mL
0264-1909_2d6d3c1f-4ea9-485c-b7b2-46c2d27d3f8d 0264-1909 HUMAN PRESCRIPTI
ON DRUG NephrAmine "HISTIDINE, ISOLEUCINE, LEUCINE, LYSINE, METHION
INE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE, and SODIUM BISULFIT
E" "INJECTION, SOLUTION" INTRAVENOUS 19780224 NDA
NDA017766 B. Braun Medical Inc. CYSTEINE HYDROCHLORIDE; HISTIDINE; ISOLE
UCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN
; VALINE .014; .25; .56; .88; .64; .88; .88; .4; .2; .64 g/100mL; g/100mL
; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
0264-1915_1c1b063a-550a-4172-863f-564f20c49c72 0264-1915 HUMAN PRESCRIPTI
ON DRUG ProcalAmine "GLYCERIN, ISOLEUCINE, LEUCINE, LYSINE, METHIONI
NE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, GLYCINE, ARGININE, HI
STIDINE, PROLINE, SERINE, CYSTEINE, SODIUM ACETATE, MAGNESIUM ACETATE, CALCIUM A
CETATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, PHOSPHORIC ACID, and POTASSIUM META
BISULFITE" INJECTION INTRAVENOUS 19820506 NDA
NDA018582 B. Braun Medical Inc. ALANINE; ARGININE; CALCIUM ACETATE; CYST
EINE HYDROCHLORIDE; GLYCERIN; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE AC
ETATE; MAGNESIUM ACETATE; METHIONINE; PHENYLALANINE; PHOSPHORIC ACID; POTASSIUM
CHLORIDE; PROLINE; SERINE; SODIUM ACETATE; SODIUM CHLORIDE; THREONINE; TRYPTOPHA
N; VALINE .21; .29; .026; .014; 3; .42; .085; .21; .27; .22; .054; .16; .1
7; .041; .15; .34; .18; .2; .12; .12; .046; .2 g/100mL; g/100mL; g/100mL; g/100
mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/10
0mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/1
00mL "Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [P
E],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Potassi
um Compounds [Chemical/Ingredient],Potassium Salt [EPC],Non-Standardized Chemica
l Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],In
creased IgG Production [PE],Allergens [Chemical/Ingredient],Glycerol [Chemical/I
ngredient],Amino Acid [EPC],Amino Acids [Chemical/Ingredient],Calculi Dissolutio
n Agent [EPC],Magnesium Ion Exchange Activity [MoA]"
0264-1940_468dc02f-1933-499f-a1f5-93eff27e4d6b 0264-1940 HUMAN PRESCRIPTI
ON DRUG POTASSIUM CHLORIDE POTASSIUM CHLORIDE "INJECTION, SOLU
TION, CONCENTRATE" PARENTERAL 19780321 ANDA ANDA0858
70 B. Braun Medical Inc. POTASSIUM CHLORIDE 14.9 g/100mL "Potassi
0264-1943_10b47d4d-4ab1-407b-8e35-0c3d7ce58ef7 0264-1943 HUMAN PRESCRIPTI
ON DRUG Hyperlyte CR Multi Electrolyte Concentrate "INJECTION, SOLU
OTHER B. Braun Medical Inc. CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; PO
TASSIUM ACETATE; SODIUM ACETATE; SODIUM CHLORIDE .37; .51; 1.96; .68; 1.1
7 g/20mL; g/20mL; g/20mL; g/20mL; g/20mL "Potassium Compounds [Chemical/I
ngredient],Potassium Salt [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Ex
change Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Facto
ient]"
0264-1965_c94d9a39-e232-4333-8c74-095df44d56e7 0264-1965 HUMAN PRESCRIPTI
ON DRUG HESPAN Hetastarch in Sodium Chloride "INJECTION, SOLUTION"
INTRAVENOUS 19910404 NDA NDA890105 B. Braun Medical
Inc. HETASTARCH; SODIUM CHLORIDE 6; .9 g/100mL; g/100mL "Plasma
Volume Expander [EPC],Increased Intravascular Volume [PE],Osmotic Activity [MoA]
,Starch [Chemical/Ingredient]"
0264-2101_bcf719f0-b005-4f01-b264-43ad3669b9a9 0264-2101 HUMAN PRESCRIPTI
ON DRUG Sterile Water Water IRRIGANT IRRIGATION 19700910
NDA NDA016734 B. Braun Medical Inc. WATER 1 mL/mL
0264-2201_6f7aa749-d391-4f57-85b2-45d889efc157 0264-2201 HUMAN PRESCRIPTI
ON DRUG Sodium Chloride Sodium Chloride IRRIGANT IRRIGATION
20090914 NDA NDA016733 B. Braun Medical Inc. SODIUM C
HLORIDE 0.9 g/100mL
0264-2202_ecf6a0b6-b959-401c-99a4-93bc9fe8e546 0264-2202 HUMAN PRESCRIPTI
ON DRUG Ringers "Sodium Chloride, Potassium Chloride, and Calcium Chlori
de" IRRIGANT IRRIGATION 19790806 NDA NDA01815
6 B. Braun Medical Inc. CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHL
ORIDE .033; .03; .86 g/100mL; g/100mL; g/100mL "Potassium Compounds [Ch
emical/Ingredient],Potassium Salt [EPC],Blood Coagulation Factor [EPC],Increased
Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalen
t [Chemical/Ingredient]"
0264-2203_7c56c5b1-0a48-43b6-b39c-954e9735d333 0264-2203 HUMAN PRESCRIPTI
ON DRUG Lactated Ringers "Sodium Chloride, Sodium Lactate, Potass
ium Chloride, and Calcium Chloride" IRRIGANT IRRIGATION 19821227
NDA NDA018681 B. Braun Medical Inc. CALCIUM CHLORIDE; POTASSIUM CHLO
RIDE; SODIUM CHLORIDE; SODIUM LACTATE .02; .03; .6; .31 g/100mL; g/100mL
; g/100mL; g/100mL "Potassium Compounds [Chemical/Ingredient],Potassium Sal
t [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE
],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient]"
0264-2205_6a839778-068d-4ddd-9fdc-6cdec05c10bd 0264-2205 HUMAN PRESCRIPTI
ON DRUG Physiolyte "Sodium Chloride, Sodium Gluconate, Sodium Aceta
te, Potassium Chloride, and Magnesium Chloride" IRRIGANT IRRIGATION
19840608 NDA NDA019024 B. Braun Medical Inc. MAGNESIU
M CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONAT
E .03; .037; .37; .53; .5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
"Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Calculi Dissolut
ion Agent [EPC],Magnesium Ion Exchange Activity [MoA]"
0264-2301_9b645c76-5937-4845-81c3-a3e2e5948eba 0264-2301 HUMAN PRESCRIPTI
ON DRUG Sorbitol Sorbitol IRRIGANT IRRIGATION
19780216 NDA NDA016741 B. Braun Medical Inc. SORBITOL
3.3 g/100mL
0264-2302_b1e62532-7654-460a-81fe-5110366ff7c8 0264-2302 HUMAN PRESCRIPTI
ON DRUG Glycine Glycine IRRIGANT IRRIGATION 19780206
NDA NDA016784 B. Braun Medical Inc. GLYCINE 1.5 g/100mL
0264-2303_a6df35d3-121c-42e9-ae15-5ca17bd286a2 0264-2303 HUMAN PRESCRIPTI
ON DRUG Mannitol Mannitol IRRIGANT IRRIGATION
19780210 NDA NDA016772 B. Braun Medical Inc. MANNITOL
5 g/100mL "Increased Diuresis [PE],Osmotic Activity [MoA],Osmotic Diuretic
[EPC]"
0264-2304_e5500abd-7ea0-4bd2-bb43-bfe581ca7474 0264-2304 HUMAN PRESCRIPTI
ON DRUG Acetic Acid Acetic Acid IRRIGANT IRRIGATION
19790806 NDA NDA018161 B. Braun Medical Inc. ACETIC A
CID 0.25 g/100mL
0264-2514_f0f620d0-55f9-41b8-a52e-40278165f128 0264-2514 HUMAN PRESCRIPTI
ON DRUG Balanced Salt "Sodium Chloride, Potassium Chloride, Calcium Ch
loride, Magnesium Chloride, Sodium Acetate, and Sodium Citrate" SOLUTION
IRRIGATION 20100203 ANDA ANDA091387 B. Braun Medical
Inc. CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE
; SODIUM CHLORIDE; SODIUM CITRATE .48; .3; .75; 3.9; 6.4; 1.7 mg/mL; m
g/mL; mg/mL; mg/mL; mg/mL; mg/mL "Potassium Compounds [Chemical/Ingredien
t],Potassium Salt [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Fac
tor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingr
edient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA]"
0264-3103_e54aedef-4aca-489d-9409-ffe8bb3297d4 0264-3103 HUMAN PRESCRIPTI
ON DRUG Cefazolin Sodium Cefazolin Sodium SOLUTION
Inc. CEFAZOLIN SODIUM 1 g/50mL "Cephalosporin Antibacterial [EP
0264-3105_e54aedef-4aca-489d-9409-ffe8bb3297d4 0264-3105 HUMAN PRESCRIPTI
ON DRUG Cefazolin Sodium Cefazolin Sodium SOLUTION
Inc. CEFAZOLIN SODIUM 2 g/50mL "Cephalosporin Antibacterial [EP
0264-3112_d12107ba-e021-4a44-8e36-19d5347dfc85 0264-3112 HUMAN PRESCRIPTI
ON DRUG Cefuroxime and Dextrose CEFUROXIME AND DEXTROSE "INJECTION, SOLU
TION" INTRAVENOUS 20010221 NDA NDA050780 B. Braun
Medical Inc. CEFUROXIME SODIUM 750 mg/50mL "Cephalosporin Antibacte
0264-3114_d12107ba-e021-4a44-8e36-19d5347dfc85 0264-3114 HUMAN PRESCRIPTI
ON DRUG Cefuroxime and Dextrose CEFUROXIME AND DEXTROSE "INJECTION, SOLU
Medical Inc. CEFUROXIME SODIUM 1.5 g/50mL "Cephalosporin Antibacte
0264-3123_e2a528c2-4699-451d-98f8-3129aa946780 0264-3123 HUMAN PRESCRIPTI
ON DRUG Cefoxitin and Dextrose CEFOXITIN SODIUM "INJECTION, SOLU
Medical Inc. CEFOXITIN SODIUM 1 g/50mL "Cephalosporin Antibacte
0264-3125_e2a528c2-4699-451d-98f8-3129aa946780 0264-3125 HUMAN PRESCRIPTI
ON DRUG Cefoxitin and Dextrose CEFOXITIN SODIUM "INJECTION, SOLU
Medical Inc. CEFOXITIN SODIUM 2 g/50mL "Cephalosporin Antibacte
0264-3143_ea583795-d769-4858-a2fa-8b8c3fa98491 0264-3143 HUMAN PRESCRIPTI
ON DRUG Ceftazidime and Dextrose CEFTAZIDIME "INJECTION, SOLU
Medical Inc. CEFTAZIDIME 1 g/50mL "Cephalosporin Antibacterial [EP
0264-3145_ea583795-d769-4858-a2fa-8b8c3fa98491 0264-3145 HUMAN PRESCRIPTI
ON DRUG Ceftazidime and Dextrose CEFTAZIDIME "INJECTION, SOLU
Medical Inc. CEFTAZIDIME 2 g/50mL "Cephalosporin Antibacterial [EP
0264-3153_b7e501be-5190-4a1a-ac81-ef07398f85d3 0264-3153 HUMAN PRESCRIPTI
ON DRUG CEFTRIAXONE AND DEXTROSE CEFTRIAXONE "INJECTION, SOLU
Medical Inc. CEFTRIAXONE SODIUM 1 g/50mL "Cephalosporin Antibacte
0264-3155_b7e501be-5190-4a1a-ac81-ef07398f85d3 0264-3155 HUMAN PRESCRIPTI
ON DRUG CEFTRIAXONE AND DEXTROSE CEFTRIAXONE "INJECTION, SOLU
Medical Inc. CEFTRIAXONE SODIUM 2 g/50mL "Cephalosporin Antibacte
0264-3173_367e39ed-cb4c-443e-87e2-3f8ea50213c7 0264-3173 HUMAN PRESCRIPTI
ON DRUG Cefotetan and Dextrose CEFOTETAN and DEXTROSE "INJECTION, SOLU
Medical Inc. CEFOTETAN DISODIUM 1 g/50mL "Cephalosporin Antibacte
0264-3175_367e39ed-cb4c-443e-87e2-3f8ea50213c7 0264-3175 HUMAN PRESCRIPTI
ON DRUG Cefotetan and Dextrose CEFOTETAN and DEXTROSE "INJECTION, SOLU
Medical Inc. CEFOTETAN DISODIUM 2 g/50mL "Cephalosporin Antibacte
0264-3193_968ef12b-cb19-465e-9458-54d1d42e862c 0264-3193 HUMAN PRESCRIPTI
ON DRUG CEFEPIME HYDROCHLORIDE AND DEXTROSE CEFEPIME HYDROCHLORIDE
"INJECTION, SOLUTION" INTRAVENOUS 20100506 NDA NDA05082
1 B. Braun Medical Inc. CEFEPIME HYDROCHLORIDE 1 g/50mL "Cephalo
0264-3195_968ef12b-cb19-465e-9458-54d1d42e862c 0264-3195 HUMAN PRESCRIPTI
ON DRUG CEFEPIME HYDROCHLORIDE AND DEXTROSE CEFEPIME HYDROCHLORIDE
1 B. Braun Medical Inc. CEFEPIME HYDROCHLORIDE 2 g/50mL "Cephalo
0264-3200_3862487e-1e55-4cb4-aeae-e3a576c744cf 0264-3200 HUMAN PRESCRIPTI
ON DRUG Amino Acids "LYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE,
ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HIST
IDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, and TYROSINE" SOLUTION
INTRAVENOUS 20120413 ANDA ANDA091112 B. Braun Medical
Inc. ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISO
LEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; TH
REONINE; TRYPTOPHAN; TYROSINE; VALINE 2.17; 1.47; 434; 749; 1.04; 894; 749; 1.
04; 1.18; 749; 1.04; 894; 592; 749; 250; 39; 960 g/100mL; g/100mL; mg/100
mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; mg/100mL; g/100mL;
mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL "Amino Acid [EPC
],Amino Acids [Chemical/Ingredient]"
0264-3205_3862487e-1e55-4cb4-aeae-e3a576c744cf 0264-3205 HUMAN PRESCRIPTI
ON DRUG Amino Acids "LYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE,
ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HIST
IDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, and TYROSINE" SOLUTION
INTRAVENOUS 20120413 ANDA ANDA091112 B. Braun Medical
Inc. ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISO
LEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; TH
REONINE; TRYPTOPHAN; TYROSINE; VALINE 2.17; 1.47; 434; 749; 1.04; 894; 749; 1.
04; 1.18; 749; 1.04; 894; 592; 749; 250; 39; 960 g/100mL; g/100mL; mg/100
mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; mg/100mL; g/100mL;
mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL "Amino Acid [EPC
],Amino Acids [Chemical/Ingredient]"
0264-4000_4735d060-8f12-4525-9397-14bd3d818d68 0264-4000 HUMAN PRESCRIPTI
ON DRUG SODIUM CHLORIDE SODIUM CHLORIDE SOLUTION INTRAVENOUS
20100623 20151001 UNAPPROVED DRUG OTHER B. Braun Medical
Inc. SODIUM CHLORIDE 0.9 g/100mL
0264-4460_98ac3792-f408-4726-a598-65579e51b05f 0264-4460 HUMAN PRESCRIPTI
ON DRUG NutriLipid I.V. Fat Emulsion Soybean Oil "INJECTION, SOLU
Medical Inc. SOYBEAN OIL 20 g/100mL
0264-5535_e7c8dd97-1352-4086-88ca-58de493b18ad 0264-5535 HUMAN PRESCRIPTI
ON DRUG METRONIDAZOLE METRONIDAZOLE SOLUTION INTRAVENOUS
19830929 NDA NDA018900 B. Braun Medical Inc. METRONID
AZOLE 500 mg/100mL "Nitroimidazole Antimicrobial [EPC],Nitroimidazo
les [Chemical/Ingredient]"
0264-7273_77e5a2dc-7324-4a3c-910f-11c7f9efb34e 0264-7273 HUMAN PRESCRIPTI
ON DRUG Potassium Chloride in Dextrose and Sodium Chloride "DEXTROS
E, SODIUM CHLORIDE, and POTASSIUM CHLORIDE" INJECTION INTRAVENOUS
19880217 NDA NDA019630 B. Braun Medical Inc. DEXTROSE
; POTASSIUM CHLORIDE; SODIUM CHLORIDE 3.3; .15; .3 g/100mL; g/100mL; g/100m
L "Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC]"
0264-7386_ce01ad9d-be9e-44c6-8e45-0b07f9e2edb6 0264-7386 HUMAN PRESCRIPTI
ON DRUG Sterile Water Sterile Water IRRIGANT IRRIGATION
20130913 NDA NDA016734 B. Braun Medical Inc. WATER
100 mL/100mL
0264-7388_dacd7f8d-8d59-44a4-975d-461852c1eb73 0264-7388 HUMAN PRESCRIPTI
ON DRUG Sodium Chloride for Irrigation Sodium Chloride for Irrigation
SOLUTION IRRIGATION 20130419 NDA NDA016733
B. Braun Medical Inc. SODIUM CHLORIDE 0.9 g/100mL
0264-7390_9ee67f44-b67e-4f23-afce-80506c475f29 0264-7390 HUMAN PRESCRIPTI
ON DRUG Glycine Glycine IRRIGANT IRRIGATION 20131204
NDA NDA016784 B. Braun Medical Inc. GLYCINE 1.5 g/100mL
0264-7510_6c95bbfe-e578-4b18-b221-df37aea9749a 0264-7510 HUMAN PRESCRIPTI
ON DRUG DEXTROSE DEXTROSE SOLUTION INTRAVENOUS
5 g/100mL
0264-7520_6c95bbfe-e578-4b18-b221-df37aea9749a 0264-7520 HUMAN PRESCRIPTI
ON DRUG DEXTROSE DEXTROSE SOLUTION INTRAVENOUS
10 g/100mL
0264-7578_bdb4a9b7-1768-44c8-ab30-b16ba2d28cfd 0264-7578 HUMAN PRESCRIPTI
ON DRUG Mannitol MANNITOL "INJECTION, SOLUTION" INTRAVEN
MANNITOL 20 g/100mL "Increased Diuresis [PE],Osmotic Activity [MoA],
Osmotic Diuretic [EPC]"
0264-7605_65b1c173-7c7b-466d-be7c-e8c3c2c8f001 0264-7605 HUMAN PRESCRIPTI
ON DRUG Dextrose And Sodium Chloride DEXTROSE and SODIUM CHLORIDE
1 B. Braun Medical Inc. DEXTROSE; SODIUM CHLORIDE 2.5; .45
g/100mL; g/100mL
1 B. Braun Medical Inc. DEXTROSE; SODIUM CHLORIDE 3.3; .3 g/100mL;
g/100mL
1 B. Braun Medical Inc. DEXTROSE; SODIUM CHLORIDE 5; .9 g/100mL;
g/100mL
g/100mL
g/100mL
g/100mL
g/100mL
g/100mL
0264-7625_469ce3e3-9cde-406f-a967-00e9744d12db 0264-7625 HUMAN PRESCRIPTI
ON DRUG POTASSIUM CHLORIDE IN DEXTROSE DEXTROSE and POTASSIUM CHLORIDE
SOLUTION INTRAVENOUS 19890929 NDA NDA019699
B. Braun Medical Inc. DEXTROSE; POTASSIUM CHLORIDE 5; .15 g/100mL; g/100mL
0264-7628_469ce3e3-9cde-406f-a967-00e9744d12db 0264-7628 HUMAN PRESCRIPTI
ON DRUG POTASSIUM CHLORIDE IN DEXTROSE DEXTROSE and POTASSIUM CHLORIDE
SOLUTION INTRAVENOUS 19890929 NDA NDA019699
B. Braun Medical Inc. DEXTROSE; POTASSIUM CHLORIDE 5; .3 g/100mL; g/100mL
; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5; .075; .45 g/100mL; g/100mL; g/100m
0264-7703_5ade9a91-52fe-4087-8918-e2721e2f43bb 0264-7703 HUMAN PRESCRIPTI
ON DRUG Isolyte S "SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETA
TE, POTASSIUM CHLORIDE, and MAGNESIUM CHLORIDE" "INJECTION, SOLUTION" INTRAVEN
MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM
GLUCONATE .03; .037; .37; .53; .5 g/100mL; g/100mL; g/100mL; g/100mL; g/10
0mL "Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Calculi
Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA]"
0264-7704_cb81fe4a-10a7-4e24-aa4f-b4315fcfe39b 0264-7704 HUMAN PRESCRIPTI
ON DRUG Isolyte S in Dextrose "Hydrous Dextrose, Sodium Chloride, Sodi
um Gluconate, Sodium Acetate Trihydrate, Potassium Chloride and Magnesium Chlori
de Hexahydrate" "INJECTION, SOLUTION" INTRAVENOUS 19930809
ANDA ANDA019843 B. Braun Medical Inc. DEXTROSE; MAGNESIUM CHLORIDE; PO
TASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE 5; .03;
.037; .37; .53; .5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
"Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Calculi Dissolut
ion Agent [EPC],Magnesium Ion Exchange Activity [MoA]"
0264-7707_db7b5796-26b4-4bd5-abc8-ce7a2b889e41 0264-7707 HUMAN PRESCRIPTI
ON DRUG Isolyte S pH 7.4 "SODIUM CHLORIDE, SODIUM GLUCONATE, SODI
UM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, a
nd POTASSIUM PHOSPHATE" "INJECTION, SOLUTION" INTRAVENOUS 19890929
NDA NDA019696 B. Braun Medical Inc. "MAGNESIUM CHLORIDE; POTASSIUM C
HLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM
GLUCONATE; SODIUM PHOSPHATE, DIBASIC" .03; .037; .00082; .37; .53; .5; .012
g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL "Potassium Compo
unds [Chemical/Ingredient],Potassium Salt [EPC],Calculi Dissolution Agent [EPC],
Magnesium Ion Exchange Activity [MoA]"
0264-7730_8b4ab42b-a486-45b6-8ab9-4d2ba5bfa683 0264-7730 HUMAN PRESCRIPTI
ON DRUG Isolyte P in Dextrose "Dextrose, Sodium Acetate, Potassium Chl
oride, Magnesium Chloride, and Potassium Phosphate, Dibasic" "INJECTION, SOLU
Medical Inc. "DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; P
OTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE" 5; .031; .13; .026; .32 g/100mL;
g/100mL; g/100mL; g/100mL; g/100mL "Potassium Compounds [Chemical/Ingredien
t],Potassium Salt [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange A
ctivity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC]"
0264-7750_5b78768f-c7eb-4bd7-a4f7-91ebfbd91273 0264-7750 HUMAN PRESCRIPTI
ON DRUG Lactated Ringers "Sodium Chloride, Sodium Lactate, Potass
ium Chloride, and Calcium Chloride" "INJECTION, SOLUTION" INTRAVENOUS
19880229 NDA NDA019632 B. Braun Medical Inc. CALCIUM
CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE .02; .03; .6; .3
1 g/100mL; g/100mL; g/100mL; g/100mL "Potassium Compounds [Chemical/I
ngredient],Potassium Salt [EPC],Blood Coagulation Factor [EPC],Increased Coagula
tion Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemi
cal/Ingredient]"
0264-7751_18607458-76ca-4880-86ad-f67e12fa799a 0264-7751 HUMAN PRESCRIPTI
ON DRUG Dextrose in Lactated Ringers "DEXTROSE, SODIUM CHLORIDE, SODI
UM LACTATE, POTASSIUM CHLORIDE, and CALCIUM CHLORIDE" "INJECTION, SOLUTION"
Inc. CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE; SODIUM CHLOR
IDE; SODIUM LACTATE .02; 5; .03; .6; .31 g/100mL; g/100mL; g/100mL; g/100
mL; g/100mL "Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],
Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calciu
m [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient]"
0264-7780_3e706e97-36da-4886-b44a-8c23ce2e8c0d 0264-7780 HUMAN PRESCRIPTI
ON DRUG Ringers "Sodium Chloride, Calcium Chloride, and Potassium Chlori
de" "INJECTION, SOLUTION" INTRAVENOUS 19920417 NDA
NDA020002 B. Braun Medical Inc. CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SO
DIUM CHLORIDE .033; .03; .86 g/100mL; g/100mL; g/100mL "Blood Coagulati
on Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ing
redient],Cations, Divalent [Chemical/Ingredient]"
0264-7800_3128dcb7-7a4f-46c5-9fd2-a919be5ab684 0264-7800 HUMAN PRESCRIPTI
SODIUM CHLORIDE 0.9 g/100mL
0264-7800_f05047f1-6df2-4aad-836b-cbab5e06fcae 0264-7800 HUMAN PRESCRIPTI
0264-7802_f05047f1-6df2-4aad-836b-cbab5e06fcae 0264-7802 HUMAN PRESCRIPTI
0264-7805_04ae0ef0-80a1-457d-a7a7-6108de0c2690 0264-7805 HUMAN PRESCRIPTI
SODIUM CHLORIDE 3 g/100mL
0264-7806_04ae0ef0-80a1-457d-a7a7-6108de0c2690 0264-7806 HUMAN PRESCRIPTI
SODIUM CHLORIDE 5 g/100mL
0264-7850_14c1ad78-1ea2-4c5e-9f08-e87be8a852e6 0264-7850 HUMAN PRESCRIPTI
ON DRUG Sterile Water Water INJECTION INTRAVENOUS 19880224
NDA NDA019633 B. Braun Medical Inc. WATER 1 mL/mL
0264-7865_4623a0b4-8a80-498a-8341-8b3be7b496c0 0264-7865 HUMAN PRESCRIPTI
ON DRUG POTASSIUM CHLORIDE IN SODIUM CHLORIDE SODIUM CHLORIDE and POTA
SSIUM CHLORIDE SOLUTION INTRAVENOUS 19890929 NDA
NDA019708 B. Braun Medical Inc. POTASSIUM CHLORIDE; SODIUM CHLORIDE
.15; .9 g/100mL; g/100mL "Potassium Compounds [Chemical/Ingredient],Potas
sium Salt [EPC]"
0264-7885_4623a0b4-8a80-498a-8341-8b3be7b496c0 0264-7885 HUMAN PRESCRIPTI
ON DRUG POTASSIUM CHLORIDE IN SODIUM CHLORIDE SODIUM CHLORIDE and POTA
SSIUM CHLORIDE SOLUTION INTRAVENOUS 19890929 NDA
NDA019708 B. Braun Medical Inc. POTASSIUM CHLORIDE; SODIUM CHLORIDE
.3; .9 g/100mL; g/100mL "Potassium Compounds [Chemical/Ingredient],Potas
sium Salt [EPC]"
0264-8612_c04b2b6e-1162-4011-a351-a5b95af57643 0264-8612 HUMAN PRESCRIPTI
ON DRUG Dextrose and Sodium Chloride Dextrose and Sodium Chloride
g/100mL
0264-9010_a7532439-29ef-433d-8505-c0a8bbfd549b 0264-9010 HUMAN PRESCRIPTI
ON DRUG FreAmine III "ISOLEUCINE, LEUCINE, LYSINE, METHIONINE, PHENYL
ALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, HISTIDINE, PROLINE, S
ERINE, GLYCINE, CYSTEINE, PHOSPHORIC ACID, and SODIUM BISULFITE" "INJECTI
ON, SOLUTION" INTRAVENOUS 19710924 NDA NDA016822
B. Braun Medical Inc. ALANINE; ARGININE; CYSTEINE HYDROCHLORIDE; GLYCINE; HIST
IDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; PHOSPHORI
C ACID; PROLINE; SERINE; THREONINE; TRYPTOPHAN; VALINE .71; .95; .016; 1.4; .28
; .69; .91; .73; .53; .56; .12; 1.12; .59; .4; .15; .66 g/100mL; g/100mL; g/100m
L; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100
mL; g/100mL; g/100mL; g/100mL; g/100mL "Amino Acid [EPC],Amino Acids [Chemical/
Ingredient]"
0264-9341_e116b93b-0b11-405d-a179-8e6ddb133c9b 0264-9341 HUMAN PRESCRIPTI
ON DRUG TrophAmine "ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE
, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDIN
E, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASP
ARTIC ACID, GLUTAMIC ACID, and TAURINE" SOLUTION INTRAVENOUS 19840720
NDA NDA019018 B. Braun Medical Inc. ALANINE; ARGININE; ASPARTIC ACID
; CYSTEINE HYDROCHLORIDE; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE
; LYSINE ACETATE; METHIONINE; N-ACETYLTYROSINE; PHENYLALANINE; PROLINE; SERINE;
TAURINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE .54; 1.2; .32; .024; .5;
.36; .48; .82; 1.4; 1.2; .34; .24; .48; .68; .38; .025; .42; .2; .044; .78
g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL;
g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
; g/100mL; g/100mL "Amino Acid [EPC],Amino Acids [Chemical/Ingredient]"
0264-9350_6ec6a7cd-2af3-4a8f-b727-755c02cd2f88 0264-9350 HUMAN PRESCRIPTI
ON DRUG FreAmine HBC "ISOLEUCINE, LEUCINE, LYSINE, METHIONINE, PHENYL
ALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, HISTIDINE, PROLINE, S
ERINE, GLYCINE, CYSTEINE, and SODIUM BISULFITE" "INJECTION, SOLUTION" INTRAVEN
ALANINE; ARGININE; CYSTEINE HYDROCHLORIDE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCI
NE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPT
OPHAN; VALINE .4; .58; .014; .33; .16; .76; 1.37; .41; .25; .32; .63; .33; .2;
.09; .88 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g
/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL "Amino A
cid [EPC],Amino Acids [Chemical/Ingredient]"
0264-9361_e116b93b-0b11-405d-a179-8e6ddb133c9b 0264-9361 HUMAN PRESCRIPTI
ON DRUG TrophAmine "ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE
, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDIN
E, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASP
ARTIC ACID, GLUTAMIC ACID, and TAURINE" SOLUTION INTRAVENOUS 19840720
NDA NDA019018 B. Braun Medical Inc. ALANINE; ARGININE; ASPARTIC ACID
; CYSTEINE HYDROCHLORIDE; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE
; LYSINE ACETATE; METHIONINE; N-ACETYLTYROSINE; PHENYLALANINE; PROLINE; SERINE;
TAURINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE .32; .73; .19; .02; .3;
.22; .29; .49; .84; .69; .2; .12; .29; .41; .23; .015; .25; .12; .044; .47
g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL;
g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
; g/100mL; g/100mL "Amino Acid [EPC],Amino Acids [Chemical/Ingredient]"
0264-9371_d026d29b-2206-4be0-8fc6-135fa90effc8 0264-9371 HUMAN PRESCRIPTI
ON DRUG HepatAmine "isoleucine, leucine, lysine acetate, methionine
, phenylalanine, threonine, tryptophan, valine, alani" "INJECTION, SOLUTION"
Inc. ALANINE; ARGININE; CYSTEINE HYDROCHLORIDE; GLYCINE; HISTIDINE; ISOLEUCIN
E; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; PHOSPHORIC ACID; PROLINE;
SERINE; THREONINE; TRYPTOPHAN; VALINE .77; .6; .014; .9; .24; .9; 1.1; .61; .1
; .1; .115; .8; .5; .45; .066; .84 g/100mL; g/100mL; g/100mL; g/100mL; g/10
0mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/1
00mL; g/100mL; g/100mL "Amino Acid [EPC],Amino Acids [Chemical/Ingredient]"
0264-9554_60468a47-bce1-442a-8375-6c45e251c914 0264-9554 HUMAN PRESCRIPTI
ON DRUG Theophylline in Dextrose Theophylline Anhydrous and Dextr
ose "INJECTION, SOLUTION" INTRAVENOUS 19920814 NDA
NDA019826 B. Braun Medical Inc. DEXTROSE MONOHYDRATE; THEOPHYLLINE ANHYD
ROUS 5; 80 g/100mL; mg/100mL "Methylxanthine [EPC],Xanthines [Chemica
l/Ingredient]"
0264-9558_60468a47-bce1-442a-8375-6c45e251c914 0264-9558 HUMAN PRESCRIPTI
ON DRUG Theophylline in Dextrose Theophylline Anhydrous and Dextr
ose "INJECTION, SOLUTION" INTRAVENOUS 19920814 NDA
NDA019826 B. Braun Medical Inc. DEXTROSE MONOHYDRATE; THEOPHYLLINE ANHYD
ROUS 5; 160 g/100mL; mg/100mL "Methylxanthine [EPC],Xanthines [Chemica
l/Ingredient]"
0264-9567_f16aa82e-b964-4e45-a7b9-5c22ffa9cdab 0264-9567 HUMAN PRESCRIPTI
ON DRUG Heparin Sodium in Dextrose Heparin Sodium and Dextrose
INJECTION INTRAVENOUS 19920720 NDA NDA019952
B. Braun Medical Inc. DEXTROSE MONOHYDRATE; HEPARIN SODIUM 5; 4000 g/100mL;
[USP'U]/100mL "Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionat
ed Heparin [EPC]"
B. Braun Medical Inc. DEXTROSE MONOHYDRATE; HEPARIN SODIUM 5; 5000 g/100mL;
[USP'U]/100mL "Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionat
ed Heparin [EPC]"
B. Braun Medical Inc. DEXTROSE MONOHYDRATE; HEPARIN SODIUM 5; 10000
g/100mL; [USP'U]/100mL "Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfr
actionated Heparin [EPC]"
0264-9594_0f66be0e-6920-4499-b35f-4f576bbbaaaf 0264-9594 HUMAN PRESCRIPTI
ON DRUG Lidocaine Hydrochloride and Dextrose LIDOCAINE HYDROCHLORIDE
ANHYDROUS and DEXTROSE MONOHYDRATE "INJECTION, SOLUTION" INTRAVENOUS
MONOHYDRATE; LIDOCAINE HYDROCHLORIDE ANHYDROUS 5; .4 g/100mL; g/100mL
0264-9598_0f66be0e-6920-4499-b35f-4f576bbbaaaf 0264-9598 HUMAN PRESCRIPTI
ON DRUG Lidocaine Hydrochloride and Dextrose LIDOCAINE HYDROCHLORIDE
ANHYDROUS and DEXTROSE MONOHYDRATE "INJECTION, SOLUTION" INTRAVENOUS
MONOHYDRATE; LIDOCAINE HYDROCHLORIDE ANHYDROUS 5; .8 g/100mL; g/100mL
0264-9872_9926fb9b-384a-463b-8a13-2aadb9e1cfb2 0264-9872 HUMAN PRESCRIPTI
ON DRUG Heparin Sodium in Sodium Chloride Heparin Sodium in Sodium
Chloride INJECTION INTRAVENOUS 19920720 NDA
NDA019953 B. Braun Medical Inc. HEPARIN SODIUM 200 [USP'U]/100mL
"Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC]
"
68306-101_33c89e2f-3332-4e25-ac2c-cdcc0acae918 68306-101 HUMAN OTC DRUG
Avant Original Instant Hand Sanitizer Alcohol GEL TOPICAL 20101005
OTC MONOGRAPH NOT FINAL part333E B4 Ventures LLC ALCOHOL 60 mL/100mL
68306-104_3b716461-0dfd-42f9-8e5c-d4d12fe05f70 68306-104 HUMAN OTC DRUG
Avant EX Alcohol GEL TOPICAL 20100515 OTC MONO
GRAPH NOT FINAL part333E B4 Ventures LLC ALCOHOL 70 mL/100mL
68306-105_db364ab9-aea4-41e8-9825-08cf7abd1bd6 68306-105 HUMAN OTC DRUG
Aterra Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20101118
OTC MONOGRAPH NOT FINAL part333E B4 Ventures LLC TRICLOSAN 3
mL/1000mL
68306-106_e1c93cb4-1416-47f1-b898-e72031190863 68306-106 HUMAN OTC DRUG
Avant Original - Fragrance Free Alcohol GEL TOPICAL 20100515
68306-109_d301ef51-4da7-4ecb-a9c2-a114f5086532 68306-109 HUMAN OTC DRUG
Avant Foaming Hand Sanitizer Alcohol LIQUID TOPICAL 20101208
68306-114_48489051-fba8-49d1-94e9-6027a615b77b 68306-114 HUMAN OTC DRUG
Avant Eco-Premium Instant Hand Sanitizer Alcohol GEL TOPICAL
20120501 OTC MONOGRAPH NOT FINAL part333E B4 Ventures LLC
ALCOHOL 70 mL/100mL
68306-108_21f2aaae-93f3-4d86-bb43-0ac3035d92c4 68306-108 HUMAN OTC DRUG
Aterra Antibacterial Foaming Hand Wash Triclosan SOAP TOPICAL
20101115 OTC MONOGRAPH NOT FINAL part333E "B4 Ventures, LL
C" TRICLOSAN 3 mL/1000mL
68306-113_8102e2ec-05b8-4a45-9a15-93370687b1cc 68306-113 HUMAN OTC DRUG
Aterra E-2 Sanitizing Foam Hand Wash Benzalkonium Chloride SOAP
TOPICAL 20120215 OTC MONOGRAPH NOT FINAL part333E "B4 Vent
ures, LLC" BENZALKONIUM CHLORIDE 25 mL/1000mL
50607-1111_fb5e49f7-4aae-4bf4-bdc4-ba23bb2a7412 50607-1111 HUMAN OTC DRUG
Instant Hand Sanitizer Instant Hand Sanitizer GEL TOPICAL 20100501
OTC MONOGRAPH FINAL part333 "B8 Sales, Inc." ALCOHOL 0.6 g/.9g
50607-5600_51d351ee-2de5-45f1-a1c2-e1b05433a300 50607-5600 HUMAN OTC DRUG
Triple Antibiotic Triple Antibiotic OINTMENT TOPICAL
20100501 OTC MONOGRAPH FINAL part333 "B8 Sales, Inc."
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 5; 5000 1/g; mg/
g; 1/g
50607-5700_ecdf4659-d30b-42a6-a987-168a2e391542 50607-5700 HUMAN OTC DRUG
First aid and Burn First aid and Burn CREAM TOPICAL 20100501
OTC MONOGRAPH FINAL part333 "B8 Sales, Inc." BENZALKONIUM CHLORIDE; L
IDOCAINE HYDROCHLORIDE 1.3; 5 mg/g; mg/g
50607-5802_9fa5a9a0-ed3b-4d00-8f8f-bd91076f587c 50607-5802 HUMAN OTC DRUG
Hydrocortisone Hydrocortisone CREAM TOPICAL 20100501
OTC MONOGRAPH FINAL part347 "B8 Sales, Inc." HYDROCORTISONE 10
mg/g
44924-002_b22d9544-8d39-4630-9b01-d85e84018e80 44924-002 HUMAN OTC DRUG
BABOR HSR Lifting Eye Cream Soybean CREAM TOPICAL 20021210
OTC MONOGRAPH NOT FINAL part310.545 "Babor Cosmetics America, Corp" SOYBEAN
0.001375 mL/30mL
44924-003_9d837528-f605-40d8-a512-a7bca21e108b 44924-003 HUMAN OTC DRUG
BABOR Baborganic Biological Enzyme Cleanser Ascorbic Acid POWDER
TOPICAL 20081101 OTC MONOGRAPH NOT FINAL part310.545 "Babor C
osmetics America, Corp" ASCORBIC ACID 0.375 g/75g
44924-004_b89bdf6f-5809-41fd-a2d2-ee7ec584da37 44924-004 HUMAN OTC DRUG
BABOR Baborganic Age Preventing Body Cream Panthenol CREAM
TOPICAL 20081101 OTC MONOGRAPH NOT FINAL part310.545 "Babor C
osmetics America, Corp" PANTHENOL 1.8 mL/200mL
44924-007_b10de72d-c3aa-4b1c-99f0-086b9aad033f 44924-007 HUMAN OTC DRUG
BABOR CLEANSING HY-OL Soybean OIL TOPICAL 20040401
UNAPPROVED DRUG OTHER "Babor Cosmetics America, Corp" SOYBEAN 78.2
mL/200mL
44924-008_3dc9e210-8c14-481c-8589-cdde3b4a7f10 44924-008 HUMAN OTC DRUG
BABOR Cleansing Mild Peeling Sesame Seed CREAM TOPICAL 20100203
UNAPPROVED DRUG OTHER "Babor Cosmetics America, Corp" SESAME SEED
3.5 mL/50mL
44924-100_a931dda5-3ffe-43ff-9b88-6dca924551ca 44924-100 HUMAN OTC DRUG
Moderate Protection Sun SPF 15 Octocrylene SPRAY TOPICAL 20100301
OTC MONOGRAPH FINAL part352 "Babor Cosmetics America, Corp" AVOBENZONE; OCTI
NOXATE; OCTOCRYLENE; SULISOBENZONE 6; 15; 20; 4 mL/200mL; mL/200mL; mL/2
00mL; mL/200mL
44924-102_57c1d612-0f0e-40ef-82b2-ec25dc0b2324 44924-102 HUMAN OTC DRUG
High Protection Sun SPF 30 Titanium Dioxide CREAM TOPICAL
20100601 OTC MONOGRAPH FINAL part352 "Babor Cosmetics America
, Corp" OCTINOXATE; TITANIUM DIOXIDE 2.252; 2.327 mL/30mL; mL/30mL
44924-111_f04b4d24-f532-45de-97f1-db260d723bee 44924-111 HUMAN OTC DRUG
Babor Body Line Thermal Smooth Effect Body PANTHENOL LOTION
TOPICAL 20100410 UNAPPROVED DRUG OTHER "Babor Cosmetics
America, Corp" PANTHENOL 1.8 mL/200mL
44924-112_7c576ea5-dc37-4ed2-800a-f6bc8e2888b9 44924-112 HUMAN OTC DRUG
BABOR Stop Cellulite Panthenol LIQUID TOPICAL 20100410
UNAPPROVED DRUG OTHER "Babor Cosmetics America, Corp" PANTHENOL
0.075 mL/10mL
44924-113_66001c50-99e0-4221-bca2-764971a2d87d 44924-113 HUMAN OTC DRUG
DR. BABOR DERMA CELLULAR Ultimate Firming Decollete Mask Glycerin
GEL TOPICAL 20100410 UNAPPROVED DRUG OTHER "Babor C
osmetics America, Corp" GLYCERIN 5.088 mL/100mL
44924-114_8aca1862-6acf-42b2-a307-b66b757b7b05 44924-114 HUMAN OTC DRUG
DR. BABOR DERMA CELLULAR Ultimate Firming Eye Panthenol GEL
America, Corp" PANTHENOL 0.01 mL/100mL
44924-115_08c13f56-3133-4d6e-b6c4-d38ee47b18f7 44924-115 HUMAN OTC DRUG
DR. BABOR Ultimate Vitamin CP Panthenol LIQUID TOPICAL 20100410
UNAPPROVED DRUG OTHER "Babor Cosmetics America, Corp" PANTHENOL
0.018 mL/2mL
44924-116_593a1371-a641-4b53-b219-564bd139c5b4 44924-116 HUMAN OTC DRUG
DR. BABOR DERMA CELLULAR Detoxifying Vitamin SPF 15 Octocrylene
CREAM TOPICAL 20100410 OTC MONOGRAPH FINAL part352 "Babor C
osmetics America, Corp" AVOBENZONE; OCTINOXATE; OCTOCRYLENE 1.5; 3.75; 5
44924-117_9d9753c2-042e-41c7-b3ab-44f53dd3efff 44924-117 HUMAN OTC DRUG
DR. BABOR DERMA Cellular Detoxifying Vitamin SPF 15 CP Octocrylene
CREAM TOPICAL 20100410 OTC MONOGRAPH FINAL part352 "Babor C
osmetics America, Corp" AVOBENZONE; OCTINOXATE; OCTOCRYLENE 6; 15; 20
44924-120_b7d07d5d-1039-4414-90ec-8c257abe78c1 44924-120 HUMAN OTC DRUG
PURE SELECT Purifying Anti-Aging CP Panthenol CREAM TOPICAL
20100615 UNAPPROVED DRUG OTHER "Babor Cosmetics America
, Corp" PANTHENOL 1.8 mL/200mL
44924-121_dc351da1-6bb4-4f13-a68f-2ea52f5b94f1 44924-121 HUMAN OTC DRUG
PURE SELECT Purifying Anti-Aging Allantoin LOTION TOPICAL
, Corp" ALLANTOIN 0.1 mL/50mL
44924-122_ba0e2aad-f714-4417-b3c8-640cde5593e7 44924-122 HUMAN OTC DRUG
Baborganic Pure Line Reducing Glycerin CREAM TOPICAL 20100609
UNAPPROVED DRUG OTHER "Babor Cosmetics America, Corp" GLYCERIN
4.9947 mL/50mL
44924-123_f2b0aaad-5575-47a7-a5a3-411100cc9b19 44924-123 HUMAN OTC DRUG
Derma Refiner Day Skin Perfecting Set Octinoxate CREAM TOPICAL
, Corp" OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 2.5; 2; 2 mL/50mL;
mL/50mL; mL/50mL
44924-124_0994c211-e04e-43e5-954e-58813c4c4ab6 44924-124 HUMAN OTC DRUG
3D Lifting Glycerin LIQUID TOPICAL 20090601
UNAPPROVED DRUG OTHER "Babor Cosmetics America, Corp" GLYCERIN
0.067 mL/2mL
44924-001_6b36211f-494a-4a51-b5c3-f520a84d54e5 44924-001 HUMAN OTC DRUG
BABOR HSR Lifting Soybean CREAM TOPICAL 20080101
UNAPPROVED DRUG OTHER "Babor Cosmetics America, Corp." SOYBEAN
0.01375 mL/50mL
44924-005_d3c9ad69-7f23-4b22-9cb1-9330801d8ba8 44924-005 HUMAN OTC DRUG
BABOR Baborganic Calm and Relax Panthenol CREAM TOPICAL 20081101
UNAPPROVED DRUG OTHER "Babor Cosmetics America, Corp." PANTHENO
L 0.04875 mL/50mL
44924-006_ec0a27ef-af00-4665-8c6a-c1839b4ef229 44924-006 HUMAN OTC DRUG
BABOR BODY LINE THERMAL Firming Body Panthenol LOTION TOPICAL
, Corp." PANTHENOL 1.5 mL/200mL
44924-009_0496069a-2957-40aa-aa14-1ca05a02870d 44924-009 HUMAN OTC DRUG
BABOR HSR Glamour Lifting Millet Seed LIQUID TOPICAL 20091101
UNAPPROVED DRUG OTHER "Babor Cosmetics America, Corp." MILLET S
EED 0.007 mL/2mL
44924-010_c66b81e8-7870-4a37-a39f-350b913fd2c6 44924-010 HUMAN OTC DRUG
BABOR Baborganic Crystal Face Scrub Meadowfoam Seed Oil CREAM
America, Corp." MEADOWFOAM SEED OIL 0.5 mL/50mL
44924-011_215bbcdd-164d-4c12-a6e1-b3f88cd3d330 44924-011 HUMAN OTC DRUG
BABOR Baborganic Crystal Face Scrub CP Meadowfoam Seed Oil CREAM
America, Corp." MEADOWFOAM SEED OIL 2 mL/200mL
44924-012_d282a4cc-1f24-4ba0-9af4-206122fb197c 44924-012 HUMAN OTC DRUG
BABOR CLEANSING Rose Toning Allantoin LOTION TOPICAL 20040415
UNAPPROVED DRUG OTHER "Babor Cosmetics America, Corp." ALLANTOI
N 0.4 mL/200mL
44924-013_706241a5-e07b-4920-bc19-094112e3038a 44924-013 HUMAN OTC DRUG
BABOR CLEANSING Mild Cleanser Panthenol LIQUID TOPICAL 20040415
L 0.75 mL/200mL
44924-014_cd56d834-b654-4674-b55d-dcc3b7e85e25 44924-014 HUMAN OTC DRUG
BABOR Cleansing Gel and Tonic Equisetum Arvense Top GEL TOPICAL
, Corp." EQUISETUM ARVENSE TOP 0.4 mL/200mL
44924-015_1c55845c-af85-4401-bf71-27c9730c43dc 44924-015 HUMAN OTC DRUG
BABOR SKINOVAGE OXYGEN Energizing CP Panthenol CREAM TOPICAL
44924-016_9c7b2597-77f8-4732-bee6-e66ee7d710b5 44924-016 HUMAN OTC DRUG
BABOR Collagen Booster Allantoin LIQUID TOPICAL 20070501
UNAPPROVED DRUG OTHER "Babor Cosmetics America, Corp." ALLANTOI
N 0.004 mL/2mL
44924-017_c8d0ffc8-09f2-42c6-a01e-7405c54a7454 44924-017 HUMAN OTC DRUG
BABOR Selection Ultimate Care Panthenol CREAM TOPICAL 20081115
L 0.4875 mL/50mL
44924-018_165ca405-0dd7-4a23-83e5-d561b86eae57 44924-018 HUMAN OTC DRUG
BABOR HSR Lifting Decollete Mask Panthenol GEL TOPICAL
44924-019_9619247b-6857-4c4a-b9cd-32fa32e14dc8 44924-019 HUMAN OTC DRUG
BABOR HSR Lifting Decollete Mask CP Panthenol GEL TOPICAL
44924-020_4f24cd6a-1990-41c9-946a-cd7e4ab66f86 44924-020 HUMAN OTC DRUG
BABOR HSR Glamour Lifting CP Millet Seed LIQUID TOPICAL 20091101
UNAPPROVED DRUG OTHER "Babor Cosmetics America, Corp." MILLET S
EED 0.007 mL/2mL
44924-101_b992eb9b-f122-4228-9fff-3a17bbb1f0ca 44924-101 HUMAN OTC DRUG
High Protection Sun SPF 30 Titanium Dioxide CREAM TOPICAL
, Corp." OCTINOXATE; TITANIUM DIOXIDE 15; 15.5 mL/200mL; mL/200
mL
44924-118_11aa115f-9817-4d43-8ea0-c3773753b83a 44924-118 HUMAN OTC DRUG
Baborganic Pure Energizing Skin Glycerin LIQUID TOPICAL 20100615
UNAPPROVED DRUG OTHER "Babor Cosmetics America, Corp." GLYCERIN
3.1406 mL/200mL
44924-119_e417df40-8bf6-455f-9f66-b3b598092f51 44924-119 HUMAN OTC DRUG
PURE SELECT Purifying Anti-Aging Panthenol CREAM TOPICAL
44924-125_b5c91dec-4508-4987-8b5f-8b03bd5fe6e9 44924-125 HUMAN OTC DRUG
Skinovage Nanocell Age Protecting Glycerin CREAM TOPICAL
, Corp." GLYCERIN 2.49 mL/50mL
44924-126_d7cbea1c-01e4-4553-8941-4be3afcec5b8 44924-126 HUMAN OTC DRUG
SPA Mediterranee for hands Repair Hand Glycerin CREAM TOPICAL
, Corp." GLYCERIN 5.15 mL/100mL
44924-130_7559f4be-6db9-40e7-abb8-d5896e8d8052 44924-130 HUMAN OTC DRUG
Dr. Babor Purity Cellular Ultimate Blemish Reducing Cream Salicyli
c Acid CREAM TOPICAL 20130201 OTC MONOGRAPH FINAL part333D
"Babor Cosmetics America, Corp." SALICYLIC ACID 1.5 g/50mL
44924-131_1e880cc0-deaf-4057-8881-c00e57538f98 44924-131 HUMAN OTC DRUG
CP Dr. Babor Purity Cellular Ultimate Blemish Reducing Cream Salicyli
c Acid CREAM TOPICAL 20130201 OTC MONOGRAPH FINAL part333D
"Babor Cosmetics America, Corp." SALICYLIC ACID 1.5 g/50mL
44924-132_2b8aad8e-bdac-4ecc-bd0b-719de13b600b 44924-132 HUMAN OTC DRUG
Dr. Babor Purity Cellular Ultimate Blemish Reducing Duo "Salicylic Acid,
Zinc Oxide" KIT 20130731 OTC MONOGRAPH FINAL
part333D "Babor Cosmetics America, Corp."
44924-133_6480416a-612b-418d-ae96-c296e23ffbbf 44924-133 HUMAN OTC DRUG
CP Dr. Babor Purity Cellular Stop Blemish Fluid Salicylic Acid LIQUID
TOPICAL 20130815 OTC MONOGRAPH FINAL part333D "Babor C
osmetics America, Corp." SALICYLIC ACID 2 mg/30mg
12121-001_31c99882-8040-4392-9a23-010f05507202 12121-001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS "Badger Welding Supplies, Inc" OXYGEN 99
L/100L
12121-002_863254ef-9f54-4c70-bcc1-1323cf18448e 12121-002 HUMAN PRESCRIPTI
19550101 UNAPPROVED MEDICAL GAS "Badger Welding Supplies
, Inc" NITROUS OXIDE 99 L/100L
12121-006_6ce53955-ed20-456a-9e43-500f1fd5020d 12121-006 HUMAN PRESCRIPTI
19550101 UNAPPROVED MEDICAL GAS "Badger Welding Supplies
, Inc" NITROGEN 99 L/100L
76102-100_54f80007-44ed-4d40-a192-22c69db117a9 76102-100 HUMAN OTC DRUG
Bakers Best Arthritis Pain Relief "METHYL SALICYLATE, MENTHOL, LID
OCAINE HYDROCHLORIDE" CREAM TOPICAL 20110210 OTC MONOGRAPH NO
T FINAL part348 Baker's Best LIDOCAINE HYDROCHLORIDE; MENTHOL; METHYL SALICYL
ATE 1; 2.5; 4.5 g/100g; g/100g; g/100g
54451-001_0a5bc10c-820a-46fe-bcc2-5edab58f56ea 54451-001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS Baker's Gas & Welding Supplies OXYGEN 999
mL/L
63162-510_8742a375-a463-41bf-b9d7-1fc303dcd62f 63162-510 HUMAN OTC DRUG
Childrens Nortemp Acetaminophen SOLUTION ORAL 20140326
OTC MONOGRAPH NOT FINAL part343 "Ballay Pharmaceuticals, Inc" ACETAMINOPHEN
160 mg/5mL
63162-518_fb610708-d80d-4598-a524-0e8f444d1696 63162-518 HUMAN OTC DRUG
Nortemp Acetaminophen SOLUTION/ DROPS ORAL 19970401
OTC MONOGRAPH NOT FINAL part343 "Ballay Pharmaceuticals, Inc" ACETAMINOPHEN
80 mg/.8mL
63162-508_34f2008d-8ed5-4ef7-8c03-c8fd56d77d93 63162-508 HUMAN OTC DRUG
Balamine DM Syrup "Chlorpheniramine Maleate, Phenylephrine Hydroch
loride, Dextromethorphan Hydrobromide" LIQUID ORAL 20130423
OTC MONOGRAPH FINAL part341 "Ballay Pharmaceuticals, Inc." CHLORPHENIRAMINE
63162-520_da947d56-e0f5-4f91-88bd-82990cd4a7c4 63162-520 HUMAN OTC DRUG
Balahist DM Syrup "Brompheniramine Maleate, Phenylephrine Hydrochl
oride, Dextromethorphan Hydrobromide" LIQUID ORAL 20140106
OTC MONOGRAPH FINAL part341 "Ballay Pharmaceuticals, Inc." BROMPHENIRAMINE
.5 mg/5mL; mg/5mL; mg/5mL
26866-001_18438c1a-c5da-4b77-b121-9a0fbca4c63a 26866-001 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS Bandy's Pharmacy Inc OXYGEN 99 L/100L
60659-0101_b8cb8d26-d65b-43f8-9418-a48de7e6a62d 60659-0101 HUMAN OTC DRUG
Bang Er Jie High-Efficiency Anti-Bacteria Monomer Silver Gel for Women
Anti-Bacteria Monomer Silver Gel "GEL, DENTIFRICE" VAGINAL 20130923
UNAPPROVED HOMEOPATHIC "Bang An Bao Medical Equipment Co., Ltd."
SILVER 350 ug/3g
60659-0102_f1b663a7-6eed-4cd0-927a-a0cae7bfc629 60659-0102 HUMAN OTC DRUG
Bang Er Jie High-Efficiency Anti-Bacteria Monomer Silver -Lotion for Women
Anti-Bacteria Monomer Silver Lotion LOTION VAGINAL 20130922
UNAPPROVED HOMEOPATHIC "Bang An Bao Medical Equipment Co., Ltd."
SILVER 20 mg/200mL
59863-325_0b56ab35-71e8-4a91-b00e-61369250e193 59863-325 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS Banner Home Care of Arizona OXYGEN 99
L/100L
60596-1072_908c6a59-8e2a-4ba3-bf40-28b4b0b3018d 60596-1072 HUMAN PRESCRIPTI
UNAPPROVED MEDICAL GAS Banner Home Medical Equipment OXYGEN 99
L/100L
10888-5001_5d0c4c38-463e-4862-a371-a17fac1e9c60 10888-5001 HUMAN PRESCRIPTI
ON DRUG Paricalcitol Paricalcitol "CAPSULE, LIQUID FILLED"
ORAL 20140327 ANDA ANDA202539 Banner Pharmacaps
PARICALCITOL 1 ug/1 "Cholecalciferol [Chemical/Ingredient],Vitamin D
3 Analog [EPC]"
3 Analog [EPC]"
3 Analog [EPC]"
10888-7135_cfbb9566-cfae-4fd3-8256-384521cefcf0 10888-7135 HUMAN PRESCRIPTI
ON DRUG PROGESTERONE PROGESTERONE CAPSULE ORAL 20140101
ANDA ANDA200900 Banner Pharmacaps PROGESTERONE 100 mg/1
"Progesterone [Chemical/Ingredient],Progesterone [EPC]"
10888-7136_cfbb9566-cfae-4fd3-8256-384521cefcf0 10888-7136 HUMAN PRESCRIPTI
ON DRUG PROGESTERONE PROGESTERONE CAPSULE ORAL 20140101
ANDA ANDA200900 Banner Pharmacaps PROGESTERONE 200 mg/1
"Progesterone [Chemical/Ingredient],Progesterone [EPC]"
10888-5006_cf6e5d46-d0fc-4708-99e9-c05169606e37 10888-5006 HUMAN PRESCRIPTI
FILLED" ORAL 20121101 ANDA ANDA078720 Banner P
harmacaps Inc AMANTADINE HYDROCHLORIDE 100 mg/1 "Influenza A M2
54046-000_11ecc847-8d6e-44f2-89b7-6dede093451f 54046-000 HUMAN OTC DRUG
PROTECTOR Alcohol Prep Pad ISOPROPYL ALCOHOL LIQUID TOPICAL
20121128 OTC MONOGRAPH NOT FINAL part333A "Baoying County
Fukang Medical Appliance Co., Ltd." ISOPROPYL ALCOHOL 700 mg/mL
98132-121_f6ca65be-cdef-4f41-a842-0925ad450bb7 98132-121 HUMAN OTC DRUG
Deep Bisque Original Titanium Dioxide and Zinc Oxide POWDER TOPICAL
20100105 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty I
nc. TITANIUM DIOXIDE; ZINC OXIDE 16; 10 g/100g; g/100g
98132-122_46ef8e6f-96f3-441e-a4ef-dc3a6d5f863e 98132-122 HUMAN OTC DRUG
bareMinerals Natural Sunscreen Light Titanium Dioxide POWDER TOPICAL
20090131 OTC MONOGRAPH FINAL part352 Bare Escentuals Beauty I
nc. TITANIUM DIOXIDE 12 g/100g
98132-123_d9c5bb8f-e1e7-4b4a-89db-78c1f34454b5 98132-123 HUMAN OTC DRUG
BareMinerals Natural Sunscreen Medium Titanium Dioxide POWDER
TOPICAL 20090131 OTC MONOGRAPH FINAL part352 Bare Escentuals
Beauty Inc. TITANIUM DIOXIDE 12 g/100g
98132-124_8a86b900-d14d-4842-842d-2a631f14c38a 98132-124 HUMAN OTC DRUG
Natural Sunscreen Tan Titanium Dioxide POWDER TOPICAL 20090131
OTC MONOGRAPH FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE
12 g/100g
98132-128_2421e199-7229-46a7-b3b5-4a669006dba0 98132-128 HUMAN OTC DRUG
BareMinerals Fair Matte Fair Matte Titanium Dioxide and Zinc Oxide POWDER
TOPICAL 20090731 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals
Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 15; 5 g/100g; g/100g
BareMinerals Light Matte Light Matte Titanium Dioxide and Zinc Oxide
POWDER TOPICAL 20090731 OTC MONOGRAPH NOT FINAL part352 Bare Esc
entuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 15; 5 g/100g; g/100g
BareMinerals Fairly Light matte Fairly Light Matte Titanium Dioxide and Zin
c Oxide POWDER TOPICAL 20090731 OTC MONOGRAPH NOT FINAL part352
Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 15; 5 g/100g;
g/100g
BareMinerals Medium Beige matte Medium Beige Matte Titanium Dioxide and Zin
g/100g
BareMinerals Medium Matte Medium Matte Titanium Dioxide and Zinc Oxide
BareMinerals Medium Tan matte Medium Tan Matte Titanium Dioxide and Zin
g/100g
BareMinerals Golden Medium matte Golden Medium Matte Titanium Dioxide
and Zinc Oxide POWDER TOPICAL 20090731 OTC MONOGRAPH NOT FINAL
part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 15; 5
g/100g; g/100g
BareMinerals Warm Tan Warm Tan Matte Titanium Dioxide and Zinc Oxide POWDER
BareMinerals Tan Matte Tan Matte Titanium Dioxide and Zinc Oxide POWDER
BareMinerals Dark Matte Dark Matte Titanium Dioxide and Zinc Oxide POWDER
BareMinerals Golden Deep matte Golden Deep Matte Titanium Dioxide and Zin
g/100g
BareMinerals Medium Deep matte Medium Deep Matte Titanium Dioxide and Zin
g/100g
BareMinerals Deepest Deep matte Deepest Deep Matte Titanium Dioxide and Zin
g/100g
BareMinerals Golden Dark matte Golden Dark Matte Titanium Dioxide and Zin
g/100g
BareMinerals Medium Dark matte Medium Dark Matte Titanium Dioxide and Zin
c Oxide POULTICE TOPICAL 20090731 OTC MONOGRAPH NOT FINAL
g/100g; g/100g
98132-147_cdafa965-da3d-4ab2-a1c0-6e95ee138512 98132-147 HUMAN OTC DRUG
Golden Tan Original Titanium Dioxide and Zinc Oxide POWDER TOPICAL
nc. TITANIUM DIOXIDE; ZINC OXIDE 11.7; 20 g/100g; g/100g
98132-148_84629839-2271-430a-a37f-e7b6e06f5c44 98132-148 HUMAN OTC DRUG
Warm Dark Original Titanium Dioxide and Zinc Oxide POWDER TOPICAL
98132-149_22c8402f-b073-47c9-87a6-c7e978f78539 98132-149 HUMAN OTC DRUG
Warm Deep Original Titanium Dioxide and Zinc Oxide POWDER TOPICAL
98132-151_a61583dc-9515-42a5-94a4-70c42e61378e 98132-151 HUMAN OTC DRUG
bareMinerals Golden Fair Matte Titanium Dioxide and Zinc Oxide POWDER
bareMinerals Fairly Medium Matte Titanium Dioxide and Zinc Oxide POWDER
BareMinerals Golden Tan matte Golden Tan Matte Titanium Dioxide and Zin
g/100g
bareMinerals Warm Dark Matte Titanium Dioxide and Zinc Oxide POWDER TOPICAL
bareMinerals Medium Beige Matte Titanium Dioxide and Zinc Oxide POWDER
98132-156_3bba3e6a-2928-4f50-8535-7ef85d2a1880 98132-156 HUMAN OTC DRUG
Warm Deep Matte Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20100105
OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE
; ZINC OXIDE 15; 5 g/100g; g/100g
98132-158_4dea5c89-c41a-47ed-a8bd-76a8ca83983a 98132-158 HUMAN OTC DRUG
BareMinerals Faux Tan Faux Tan Titanium Dioxide POWDER TOPICAL
98132-159_d06886ac-6218-48c3-a2b5-b08f055dc444 98132-159 HUMAN OTC DRUG
BareMinerals Mineral Veil Titanium Dioxide and Zinc Oxide POWDER TOPICAL
98132-160_d06886ac-6218-48c3-a2b5-b08f055dc444 98132-160 HUMAN OTC DRUG
BareMinerals Tinted Mineral Veil Titanium Dioxide and Zinc Oxide POWDER
98132-161_e393dbba-bc6a-463f-bb3e-3afc30d6b2c5 98132-161 HUMAN OTC DRUG
BareMinerals Bronzing Mineral Veil Titanium Dioxide and Zinc Oxide POWDER
98132-162_7b4cf4ec-8db5-4db6-91a2-4dea25f70457 98132-162 HUMAN OTC DRUG
bareMinerals Well-rested Titanium Dioxide POWDER TOPICAL 20110105
OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE
20 g/100g
98132-163_0868a280-c497-4ea1-b756-77d6d5d79a4b 98132-163 HUMAN OTC DRUG
Ready Foundation Fair Titanium Dioxide and Zinc Oxide POWDER TOPICAL
Ready Foundation Fairly Light Titanium Dioxide and Zinc Oxide POWDER
Ready Foundation Golden Fair Titanium Dioxide and Zinc Oxide POWDER
Ready Foundation Light Titanium Dioxide and Zinc Oxide POWDER TOPICAL
Ready Foundation Fairly Medium Titanium Dioxide and Zinc Oxide POWDER
Ready Foundation Medium Titanium Dioxide and Zinc Oxide POWDER TOPICAL
Ready Foundation Medium Beige Titanium Dioxide and Zinc Oxide POWDER
Ready Foundation Golden Medium Titanium Dioxide and Zinc Oxide POWDER
Ready Foundation Medium Tan Titanium Dioxide and Zinc Oxide POWDER
Ready Foundation Tan Titanium Dioxide and Zinc Oxide POWDER TOPICAL
Ready Foundation Warm Tan Titanium Dioxide and Zinc Oxide POWDER
Ready Foundation Golden Tan Titanium Dioxide and Zinc Oxide POWDER
Ready Foundation Dark Titanium Dioxide and Zinc Oxide POWDER TOPICAL
Ready Foundation Medium Dark Titanium Dioxide and Zinc Oxide POWDER
Ready Foundation Warm Dark Titanium Dioxide and Zinc Oxide POWDER
Ready Foundation Golden Dark Titanium Dioxide and Zinc Oxide POWDER
Ready Foundation Medium Deep Titanium Dioxide and Zinc Oxide POWDER
Ready Foundation Deepest Deep Titanium Dioxide and Zinc Oxide POWDER
Ready Foundation Golden Deep Titanium Dioxide and Zinc Oxide POWDER
Ready Foundation Warm Deep Titanium Dioxide and Zinc Oxide POWDER
98132-184_13e5d3d9-928d-4e92-a382-7e084f48f85c 98132-184 HUMAN OTC DRUG
Antioxidant Primer Titanium Dioxide and Zinc Oxide CREAM TOPICAL
nc. TITANIUM DIOXIDE; ZINC OXIDE 26; 62 mg/mL; mg/mL
98132-186_7797d4f9-33ac-4327-bd21-479ecf67ea43 98132-186 HUMAN OTC DRUG
Pure Transformation Sheer Fair Titanium Dioxide and Zinc Oxide POWDER
98132-187_5a51c4b8-6823-4813-9a24-05e9c2289cf5 98132-187 HUMAN OTC DRUG
Pure Transformation Sheer Light Titanium Dioxide and Zinc Oxide POWDER
Pure Transformation Sheer Medium Titanium Dioxide and Zinc Oxide
98132-189_7797d4f9-33ac-4327-bd21-479ecf67ea43 98132-189 HUMAN OTC DRUG
Pure Transformation Sheer Tan Titanium Dioxide and Zinc Oxide POWDER
98132-190_d9974e93-5303-4639-b933-5c438d49dc2f 98132-190 HUMAN OTC DRUG
Pure Transformation Sheer Clear Titanium Dioxide and Zinc Oxide POWDER
Pure Transformation Sheer Dark Titanium Dioxide and Zinc Oxide POWDER
98132-2131_6e877759-8ddb-49d8-be13-25eb21229299 98132-2131 HUMAN OTC DRUG
bareMinerals Ready SPF 15 Touch Up Veil Titanium Dioxide POWDER
Beauty Inc. TITANIUM DIOXIDE 1.2 g/10g
98132-2132_6e877759-8ddb-49d8-be13-25eb21229299 98132-2132 HUMAN OTC DRUG
bareMinerals Ready SPF 15 Touch Up Veil Titanium Dioxide POWDER
98132-300_8d1efefb-71a5-4656-acbb-4ac4d11cfcd1 98132-300 HUMAN OTC DRUG
bareMinerals READY Touch Up Veil Broad Spectrum SPF 15 Translucent Titanium
Dioxide and Zinc oxide POWDER TOPICAL 20130601 OTC MONOGRAPH NO
T FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE
1470; 100 mg/10g; mg/10g
bareMinerals READY Touch Up Veil Broad Spectrum SPF 15 Tan Titanium Dioxide
and Zinc oxide POWDER TOPICAL 20130601 OTC MONOGRAPH NOT FINAL
0 mg/10g; mg/10g
bareMinerals READY Touch Up Veil Broad Spectrum SPF 15 Light Titanium Dioxide
0 mg/10g; mg/10g
bareMinerals READY Touch Up Veil Broad Spectrum SPF 15 Medium Titanium Dioxide
0 mg/10g; mg/10g
bareMinerals READY Touch Up Veil Broad Spectrum SPF 15 Dark Titanium Dioxide
0 mg/10g; mg/10g
bareMinerals READY Touch Up Veil Broad Spectrum SPF 15 Deep Titanium Dioxide
0 mg/10g; mg/10g
98132-664_782d8e17-e356-4504-b328-ef58861e42cf 98132-664 HUMAN OTC DRUG
BareMinerals SPF 20 Correcting Concealer Titanium Dioxide CREAM
98132-870_3d4a19fe-fbe5-455a-82f6-c40666ae7b37 98132-870 HUMAN OTC DRUG
Medium Tan Foundation SPF 15 "Titanium Dioxide, Zinc Oxide" POWDER
98132-871_9868751e-eb22-4e5d-9475-014cefd78a54 98132-871 HUMAN OTC DRUG
Fair Foundation SPF 15 "Zinc Oxide, Titanium Dioxide" POWDER TOPICAL
98132-872_2d9bce93-3f3d-4795-ba1b-27bbf735b228 98132-872 HUMAN OTC DRUG
Fairly Light Foundation SPF 15 Titanium Dioxide POWDER TOPICAL
98132-873_eeefcd92-db23-4f7f-8605-4b7b2b70580e 98132-873 HUMAN OTC DRUG
Light Foundation SPF 15 "Titanium Dioxide, Zinc Oxide" POWDER TOPICAL
98132-876_3713ec88-b55b-4951-b52d-45bdc9efc2b0 98132-876 HUMAN OTC DRUG
Bisque Foundation SPF 20 Titanium Dioxide POWDER TOPICAL
98132-877_eeefcd92-db23-4f7f-8605-4b7b2b70580e 98132-877 HUMAN OTC DRUG
Light Foundation SPF 15 "Titanium Dioxide, Zinc Oxide" POWDER TOPICAL
98132-879_9868751e-eb22-4e5d-9475-014cefd78a54 98132-879 HUMAN OTC DRUG
Fair Foundation SPF 15 "Zinc Oxide, Titanium Dioxide" POWDER TOPICAL
98132-880_179c1df2-9660-4c0d-b9a5-4128d08d2260 98132-880 HUMAN OTC DRUG
Medium Foundation SPF 15 Titanium Dioxide POWDER TOPICAL
98132-881_467bc3ea-a9bd-475a-8f9a-a958a1ce6638 98132-881 HUMAN OTC DRUG
Medium Beige Foundation SPF 15 "Zinc Oxide, Titanium Dioxide" POWDER
98132-882_3d4a19fe-fbe5-455a-82f6-c40666ae7b37 98132-882 HUMAN OTC DRUG
Medium Tan Foundation SPF 15 "Titanium Dioxide, Zinc Oxide" POWDER
98132-883_5a5251e4-13f1-466a-8966-fcd37664318f 98132-883 HUMAN OTC DRUG
Tan Foundation SPF 15 "Titanium Dioxide, Zinc Oxide" POWDER TOPICAL
98132-884_e1270697-fded-43ab-b53d-07b67b14d05a 98132-884 HUMAN OTC DRUG
Warm Tan Foundation SPF 15 "Titanium Dioxide, Zinc Oxide" POWDER
98132-885_5190d2ac-334d-4720-a452-d4f2ec089d96 98132-885 HUMAN OTC DRUG
Golden Deep Foundation SPF 15 "Zinc Oxide, Titanium Dioxide" POWDER
98132-887_015dd32a-11cc-433c-8b97-f636e956782b 98132-887 HUMAN OTC DRUG
Deepest Deep Zinc Oxide POWDER TOPICAL 20100113
OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. ZINC OXIDE
18 g/100g
98132-888_50a12509-b6de-4abd-a1aa-8aff0b4ebf21 98132-888 HUMAN OTC DRUG
Medium Deep Foundation SPF 15 "Zinc Oxide, Titanium Dioxide" POWDER
98132-889_3ee69419-86c7-4177-886e-bafc40ea4cfe 98132-889 HUMAN OTC DRUG
Medium Dark Foundation SPF 15 "Titanium Dioxide, Zinc Oxide" POWDER
98132-890_3b6f890b-9ec7-4fa2-a3f8-1d24233cd35d 98132-890 HUMAN OTC DRUG
Golden Dark Foundation SPF 15 "Titanium Dioxide, Zinc Oxide" POWDER
98132-891_39b9a8d9-05db-41d9-b8fd-60a714d1aa18 98132-891 HUMAN OTC DRUG
Golden Medium Foundation SPF 15 Titanium Dioxide POWDER TOPICAL
98132-893_d1d7af80-6692-4807-b904-acf8e1a5fa06 98132-893 HUMAN OTC DRUG
Dark Foundation SPF 15 "Titanium Dioxide, Zinc Oxide" POWDER TOPICAL
98132-902_5a9b2d8b-9eff-4367-8a75-1e61ab27f9e7 98132-902 HUMAN OTC DRUG
Honey Bisque Foundation SPF 20 "Titanium Dioxide, Zinc Oxide" POWDER
98132-903_44fec199-21ac-44f0-a0d6-9130cb48ad31 98132-903 HUMAN OTC DRUG
Summer Bisque Foundation SPF 20 "Titanium Dioxide, Zinc Oxide" POWDER
98132-904_ea41fc02-08ed-47b9-953c-da23330ec2f8 98132-904 HUMAN OTC DRUG
BareMinerals Multi-Tasking SPF 20 Concealer Dark Bisque "Titanium Dioxid
e, Zinc Oxide" POWDER TOPICAL 20100901 OTC MONOGRAPH NOT FINAL
g/100g; g/100g
98132-920_ca213e30-9b91-4ec2-8b4d-7304545affe8 98132-920 HUMAN OTC DRUG
Deep Bisque Foundation SPF 20 "Titanium Dioxide, Zinc oxide" POWDER
98132-923_810dc98b-c256-4f0c-8a33-ec41137e20e6 98132-923 HUMAN OTC DRUG
Golden Fair Foundation SPF 15 "Titanium Dioxide, Zinc Oxide" POWDER
Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 25; 7.2 g/100g; g/100g
98132-924_822c0ccb-3a77-436d-88c6-dacc56749a95 98132-924 HUMAN OTC DRUG
Fairly Medium Foundation SPF 15 "Titanium Dioxide, Zinc Oxide" POWDER
Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 25; 9.3 g/100g; g/100g
98132-700_6e756d5d-3d51-463b-9c29-dac6c238ac5e 98132-700 HUMAN OTC DRUG
bareMinerals 5-in-1 BB Advanced Performance Eyeshadow Broad Spectrum SPF 15
Candlelit Peach Titanium Dioxide CREAM TOPICAL 20140301
OTC MONOGRAPH NOT FINAL part352 "Bare Escentuals Beauty, Inc." TITANIUM DIOXIDE
170 mg/mL
Radiant Sand Titanium Dioxide CREAM TOPICAL 20140301
170 mg/mL
Soft Shell Titanium Dioxide CREAM TOPICAL 20140301
170 mg/mL
Elegant Taupe Titanium Dioxide CREAM TOPICAL 20140301
170 mg/mL
Soft Linen Titanium Dioxide CREAM TOPICAL 20140301
170 mg/mL
Sweet Spice Titanium Dioxide CREAM TOPICAL 20140301
170 mg/mL
Delicate Moss Titanium Dioxide CREAM TOPICAL 20140301
170 mg/mL
Barely Nude Titanium Dioxide CREAM TOPICAL 20140301
170 mg/mL
Blushing Pink Titanium Dioxide CREAM TOPICAL 20140301
170 mg/mL
Divine Wine Titanium Dioxide CREAM TOPICAL 20140301
170 mg/mL
98132-710_c37b213d-d584-4947-a8e4-6056c457b7a6 98132-710 HUMAN OTC DRUG
Buxom Show Some Skin Weightless Foundation Broad Spectrum SPF 30 Fair Gam
e Octinoxate and Titanium Dioxide LIQUID TOPICAL 20140130
OTC MONOGRAPH NOT FINAL part352 "Bare Escentuals Beauty, Inc." OCTINOXATE; TITA
NIUM DIOXIDE 74; 61 mg/mL; mg/mL
Buxom Show Some Skin Weightless Foundation Broad Spectrum SPF 30 Dim The
Light Octinoxate and Titanium Dioxide LIQUID TOPICAL 20140130
Buxom Show Some Skin Weightless Foundation Broad Spectrum SPF 30 In The B
uff Octinoxate and Titanium Dioxide LIQUID TOPICAL 20140130
Buxom Show Some Skin Weightless Foundation Broad Spectrum SPF 30 Youre A
Natural Octinoxate and Titanium Dioxide LIQUID TOPICAL 20140130
Buxom Show Some Skin Weightless Foundation Broad Spectrum SPF 30 Meet Me
Latte Octinoxate and Titanium Dioxide LIQUID TOPICAL 20140130
Buxom Show Some Skin Weightless Foundation Broad Spectrum SPF 30 Sweet As
Honey Octinoxate and Titanium Dioxide LIQUID TOPICAL 20140130
Buxom Show Some Skin Weightless Foundation Broad Spectrum SPF 30 Tan-Tali
ze Me Octinoxate and Titanium Dioxide LIQUID TOPICAL 20140130
Buxom Show Some Skin Weightless Foundation Broad Spectrum SPF 30 Almond T
he Nude Octinoxate and Titanium Dioxide LIQUID TOPICAL 20140130
Buxom Show Some Skin Weightless Foundation Broad Spectrum SPF 30 Caramel
Kisses Octinoxate and Titanium Dioxide LIQUID TOPICAL 20140130
Buxom Show Some Skin Weightless Foundation Broad Spectrum SPF 30 In The D
ark Octinoxate and Titanium Dioxide LIQUID TOPICAL 20140130
98132-720_3c85e1ac-7b22-445c-bd55-ef7d5448f30d 98132-720 HUMAN OTC DRUG
bareMinerals Advanced Protection SPF 20 Moisturizer Combination Skin
Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20131231 OTC MONO
GRAPH NOT FINAL part352 "Bare Escentuals Beauty, Inc." TITANIUM DIOXIDE; ZINC O
XIDE 50; 30 mg/mL; mg/mL
98132-721_7f668ca5-1357-4899-b8b5-d39825aa1db8 98132-721 HUMAN OTC DRUG
bareMinerals Advanced Protection SPF 20 Moisturizer Sheer Tint Combination S
kin Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20131231
; ZINC OXIDE 50; 30 mg/mL; mg/mL
98132-722_605838e6-ee08-42c8-be1a-a3aa20b9b50c 98132-722 HUMAN OTC DRUG
bareMinerals Advanced Protection SPF 20 Moisturizer Normal to Dry Skin
Titanium Dioxide LOTION TOPICAL 20131231 OTC MONOGRAPH NO
T FINAL part352 "Bare Escentuals Beauty, Inc." TITANIUM DIOXIDE 60
mg/mL
98132-723_63d8d0cd-6fa7-4ed5-a014-a4b09ba348a9 98132-723 HUMAN OTC DRUG
bareMinerals Advanced Protection SPF 20 Moisturizer Sheer Tint Normal to Dry
Skin Titanium Dioxide LOTION TOPICAL 20131231 OTC MONO
GRAPH NOT FINAL part352 "Bare Escentuals Beauty, Inc." TITANIUM DIOXIDE
60 mg/mL
98132-724_9de5fcaf-8ee5-4b95-9c4e-3dd5a5774b02 98132-724 HUMAN OTC DRUG
bareMinerals Daily Defense Broad Spectrum SPF 30 Titanium Dioxide
and Zinc Oxide LOTION TOPICAL 20131231 OTC MONOGRAPH NOT FINAL
part352 "Bare Escentuals Beauty, Inc." TITANIUM DIOXIDE; ZINC OXIDE 30; 1530
mg/mL; mg/mL
98132-725_a3f1626d-a481-4615-bd93-23d9e71dbf4a 98132-725 HUMAN OTC DRUG
bareMinerals Blemish Therapy Sulfur POWDER TOPICAL 20131231
OTC MONOGRAPH FINAL part333D "Bare Escentuals Beauty, Inc." SULFUR
30 mg/g
98132-726_e5f6f077-bbe4-4ec2-a089-c7b2b32c680f 98132-726 HUMAN OTC DRUG
bareMinerals Prime Time BB Primer Daily Defense Broad Spectrum SPF 30 Fair
Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20140201 OTC MONO
bareMinerals Prime Time BB Primer Daily Defense Broad Spectrum SPF 30 Light
bareMinerals Prime Time BB Primer Daily Defense Broad Spectrum SPF 30 Medium
bareMinerals Prime Time BB Primer Daily Defense Broad Spectrum SPF 30 Tan
98132-730_4b091aa5-a5aa-4081-8709-f3382f1382b6 98132-730 HUMAN OTC DRUG
bareMinerals bareSkin Pure Brightening Serum Foundation Broad Spectrum SPF 20
Bare Porcelain Titanium Dioxide LIQUID TOPICAL 20140221
110 mg/mL
Bare Shell Titanium Dioxide LIQUID TOPICAL 20140221
110 mg/mL
Bare Linen Titanium Dioxide LIQUID TOPICAL 20140221
110 mg/mL
Bare Ivory Titanium Dioxide LIQUID TOPICAL 20140221
110 mg/mL
Bare Cream Titanium Dioxide LIQUID TOPICAL 20140221
110 mg/mL
Bare Satin Titanium Dioxide LIQUID TOPICAL 20140221
110 mg/mL
Bare Natural Titanium Dioxide LIQUID TOPICAL 20140221
110 mg/mL
Bare Beige Titanium Dioxide LIQUID TOPICAL 20140221
110 mg/mL
Bare Nude Titanium Dioxide LIQUID TOPICAL 20140221
110 mg/mL
Bare Buff Titanium Dioxide LIQUID TOPICAL 20140221
110 mg/mL
Bare Latte Titanium Dioxide LIQUID TOPICAL 20140221
110 mg/mL
Bare Sand Titanium Dioxide LIQUID TOPICAL 20140221
110 mg/mL
Bare Tan Titanium Dioxide LIQUID TOPICAL 20140221
110 mg/mL
Bare Caramel Titanium Dioxide LIQUID TOPICAL 20140221
110 mg/mL
Bare Honey Titanium Dioxide LIQUID TOPICAL 20140221
110 mg/mL
Bare Almond Titanium Dioxide LIQUID TOPICAL 20140221
110 mg/mL
Bare Maple Titanium Dioxide LIQUID TOPICAL 20140221
110 mg/mL
Bare Walnut Titanium Dioxide LIQUID TOPICAL 20140221
110 mg/mL
Bare Espresso Titanium Dioxide LIQUID TOPICAL 20140221
110 mg/mL
Bare Mocha Titanium Dioxide LIQUID TOPICAL 20140221
110 mg/mL
98132-750_80d8d989-51d6-4912-bfd0-ca99b69be7c3 98132-750 HUMAN OTC DRUG
bareMinerals 5-in-1 BB Advanced Performance Mineral Veil Finishing Broad Spectru
m SPF 20 Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20140315
; ZINC OXIDE .2; .2 g/g; g/g
61164-1001_e7b2a8fc-fa82-496f-b328-f9c2a271143c 61164-1001 HUMAN OTC DRUG
MOBARONA HAIR TONIC CURCUMA AROMATICA ROOT OIL LIQUID TOPICAL
20131123 UNAPPROVED DRUG OTHER "Barona Co., Ltd"
CURCUMA AROMATICA ROOT OIL 15 g/100mL
0555-0033_7ab6c05a-8236-46c8-a555-eaf06674f669 0555-0033 HUMAN PRESCRIPTI
CAPSULE ORAL 19900930 ANDA ANDA083116 Barr Laboratorie
s Inc. CHLORDIAZEPOXIDE HYDROCHLORIDE 10 mg/1 "Benzodiazepine [EPC],Be
0555-0066_e52d3ab7-6583-4026-b79e-7cf9c50617cb 0555-0066 HUMAN PRESCRIPTI
ANDA ANDA080936 Barr Laboratories Inc. ISONIAZID 100 mg/1
Antimycobacterial [EPC]
0555-0071_e52d3ab7-6583-4026-b79e-7cf9c50617cb 0555-0071 HUMAN PRESCRIPTI
ANDA ANDA080937 Barr Laboratories Inc. ISONIAZID 300 mg/1
Antimycobacterial [EPC]
0555-0094_b898d6f1-a2db-49a4-b80d-2deabf0c3772 0555-0094 HUMAN PRESCRIPTI
ON DRUG Clonazepam Clonazepam "TABLET, ORALLY DISINTEGRATING"
ORAL 20050810 ANDA ANDA077194 Barr Laboratories Inc.
CLONAZEPAM 0.125 mg/1 "Benzodiazepine [EPC],Benzodiazepines [Chemical/
Ingredient]" CIV
Ingredient]" CIV
Ingredient]" CIV
CLONAZEPAM 1 mg/1 "Benzodiazepine [EPC],Benzodiazepines [Chemical/
Ingredient]" CIV
CLONAZEPAM 2 mg/1 "Benzodiazepine [EPC],Benzodiazepines [Chemical/
Ingredient]" CIV
0555-0138_5fd5061f-3f9b-4c74-b2f7-f9b4b92826c0 0555-0138 HUMAN PRESCRIPTI
20080828 ANDA ANDA077605 Barr Laboratories Inc. GALANTAM
INE HYDROBROMIDE 4 mg/1 "Cholinesterase Inhibitor [EPC],Cholines
0555-0171_ce9bdedb-865d-4403-967b-da65d7f37b70 0555-0171 HUMAN PRESCRIPTI
ON DRUG Mefloquine Hydrochloride Mefloquine Hydrochloride
TABLET ORAL 20040106 ANDA ANDA076392 Barr Laboratorie
s Inc. MEFLOQUINE HYDROCHLORIDE 250 mg/1 Antimalarial [EPC]
0555-0211_1c9b90cc-fb18-415e-b9b3-ca710413016c 0555-0211 HUMAN PRESCRIPTI
ON DRUG Norethindrone Acetate Norethindrone Acetate TABLET ORAL
20010629 ANDA ANDA075951 Barr Laboratories Inc. NORETHIN
DRONE ACETATE 5 mg/1 "Progesterone Congeners [Chemical/Ingredient],Pr
ogestin [EPC]"
0555-0252_4be61c39-5cde-4333-9475-0f29020d5d02 0555-0252 HUMAN PRESCRIPTI
ON DRUG Dipyridamole Dipyridamole "TABLET, FILM COATED" ORAL
19801001 ANDA ANDA087184 Barr Laboratories Inc. DIPYRIDA
MOLE 25 mg/1 "Decreased Platelet Aggregation [PE],Platelet Aggregatio
n Inhibitor [EPC]"
n Inhibitor [EPC]"
n Inhibitor [EPC]"
0555-0302_28bfea9f-c840-4a16-a127-56c72c27f38e 0555-0302 HUMAN PRESCRIPTI
19840701 ANDA ANDA088487 Barr Laboratories Inc. HYDROXYZ
INE PAMOATE 50 mg/1 "Antihistamine [EPC],Histamine Receptor Antagoni
sts [MoA]"
sts [MoA]"
sts [MoA]"
0555-0344_5434054e-77e4-4bdc-952e-6847127458b1 0555-0344 HUMAN PRESCRIPTI
ON DRUG Errin Norethindrone TABLET ORAL 20030108
ANDA ANDA076225 Barr Laboratories Inc. NORETHINDRONE 0.35 mg/1
0555-0381_22ae912c-5563-4121-b003-4d62fa6aa822 0555-0381 HUMAN PRESCRIPTI
ON DRUG Meperidine Hydrochloride Meperidine Hydrochloride
s Inc. MEPERIDINE HYDROCHLORIDE 50 mg/1 "Full Opioid Agonists [M
0555-0382_ce01b36b-f5dd-43f2-8d23-1a35425054e6 0555-0382 HUMAN PRESCRIPTI
TABLET ORAL 19961011 20160731 ANDA ANDA088640 Barr Lab
oratories Inc. MEPERIDINE HYDROCHLORIDE 100 mg/1 "Full Opioid Ago
0555-0392_22ae912c-5563-4121-b003-4d62fa6aa822 0555-0392 HUMAN PRESCRIPTI
s Inc. MEPERIDINE HYDROCHLORIDE 100 mg/1 "Full Opioid Agonists [M
0555-0483_4b7471b7-1883-45f2-b270-c5f7d5c9a302 0555-0483 HUMAN PRESCRIPTI
ON DRUG Amiloride Hydrochloride and Hydrochlorothiazide Amiloride Hydroc
ANDA071111 Barr Laboratories Inc. AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIA
ZIDE 5; 50 mg/1; mg/1 "Decreased Renal K+ Excretion [PE],Increased Diu
resis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diu
retic [EPC],Thiazides [Chemical/Ingredient]"
0555-0484_92d0bb3e-0574-4ccb-99ec-66ec4dc39c27 0555-0484 HUMAN PRESCRIPTI
ON DRUG Leucovorin Calcium Leucovorin Calcium TABLET ORAL
19900630 ANDA ANDA071198 Barr Laboratories Inc. LEUCOVOR
IN CALCIUM 5 mg/1 "Folate Analog [EPC],Folic Acid [Chemical/Ingred
ient]"
0555-0485_92d0bb3e-0574-4ccb-99ec-66ec4dc39c27 0555-0485 HUMAN PRESCRIPTI
ON DRUG Leucovorin Calcium Leucovorin Calcium TABLET ORAL
19900630 ANDA ANDA071199 Barr Laboratories Inc. LEUCOVOR
IN CALCIUM 25 mg/1 "Folate Analog [EPC],Folic Acid [Chemical/Ingred
ient]"
0555-0572_cd002dc0-f02b-4f98-8f27-c84005ee8d8a 0555-0572 HUMAN PRESCRIPTI
ON DRUG Methotrexate Methotrexate TABLET ORAL 19901101
ANDA ANDA081099 Barr Laboratories Inc. METHOTREXATE SODIUM 2.5
mg/1 "Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitor
s [MoA]"
0555-0588_45b4da17-db8a-4c06-a10b-f9274dc5c9a4 0555-0588 HUMAN PRESCRIPTI
ON DRUG Didanosine Didanosine "CAPSULE, DELAYED RELEASE PELLET
S" ORAL 20041215 ANDA ANDA077167 Barr Laboratorie
s Inc. DIDANOSINE 200 mg/1 "Human Immunodeficiency Virus Nucleoside
0555-0594_17c70468-0a6f-4510-a5c1-9d6ac564819b 0555-0594 HUMAN PRESCRIPTI
ON DRUG Protriptyline Hydrochloride Protriptyline Hydrochloride
Barr Laboratories Inc. PROTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricycli
c Antidepressant [EPC]
0555-0595_17c70468-0a6f-4510-a5c1-9d6ac564819b 0555-0595 HUMAN PRESCRIPTI
ON DRUG Protriptyline Hydrochloride Protriptyline Hydrochloride
Barr Laboratories Inc. PROTRIPTYLINE HYDROCHLORIDE 5 mg/1 Tricycli
c Antidepressant [EPC]
0555-0606_95aab0c8-051c-48ad-9b14-89572e2f4884 0555-0606 HUMAN PRESCRIPTI
ON DRUG Megestrol Acetate Megestrol Acetate TABLET ORAL
19961025 ANDA ANDA074621 Barr Laboratories Inc. MEGESTRO
L ACETATE 20 mg/1 "Progesterone Congeners [Chemical/Ingredient],Pr
ogestin [EPC]"
0555-0607_95aab0c8-051c-48ad-9b14-89572e2f4884 0555-0607 HUMAN PRESCRIPTI
ON DRUG Megestrol Acetate Megestrol Acetate TABLET ORAL
19951130 ANDA ANDA074621 Barr Laboratories Inc. MEGESTRO
L ACETATE 40 mg/1 "Progesterone Congeners [Chemical/Ingredient],Pr
ogestin [EPC]"
0555-0633_493fa059-0dc2-437f-a738-b7e40091ed5d 0555-0633 HUMAN PRESCRIPTI
ANDA074582 Barr Laboratories Inc. DANAZOL 50 mg/1 "Androgen [EPC],
0555-0658_18cb66f6-f17f-446a-82f8-6c09b32b29ff 0555-0658 HUMAN PRESCRIPTI
CAPSULE ORAL 19990520 20160229 ANDA ANDA040289 Barr Lab
oratories Inc. ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 500; 5 mg/1; mg/1
0555-0701_f149ef1c-0ec8-45d6-9b56-fe6108d0ac4d 0555-0701 HUMAN PRESCRIPTI
Barr Laboratories Inc. DEMECLOCYCLINE HYDROCHLORIDE 150 mg/1 "Tetracy
cline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient]"
0555-0702_f149ef1c-0ec8-45d6-9b56-fe6108d0ac4d 0555-0702 HUMAN PRESCRIPTI
Barr Laboratories Inc. DEMECLOCYCLINE HYDROCHLORIDE 300 mg/1 "Tetracy
cline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient]"
0555-0715_7d9c5345-a2b4-4f48-9e75-61ef21a80aac 0555-0715 HUMAN PRESCRIPTI
ON DRUG Camila Norethindrone TABLET ORAL 20021030
ANDA ANDA076177 Barr Laboratories Inc. NORETHINDRONE 0.35 mg/1
0555-0733_b2ee236d-5b27-40a7-893f-345b0b42146a 0555-0733 HUMAN PRESCRIPTI
19990503 ANDA ANDA071196 Barr Laboratories Inc. TRAZODON
E HYDROCHLORIDE 300 mg/1 Serotonin Reuptake Inhibitor [EPC]
0555-0762_7ad6983d-1e30-450e-8122-26418ae6efed 0555-0762 HUMAN PRESCRIPTI
ON DRUG Adderall "Dextroamphetamine Saccharate, Amphetamine Aspar
tate, Dextroamphetamine Sulfate, and Amphetamine Sulfate" TABLET ORAL
20080811 20150831 ANDA ANDA040422 Barr Laboratories Inc.
AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHA
RATE; DEXTROAMPHETAMINE SULFATE 1.25; 1.25; 1.25; 1.25 mg/1; mg/1; mg/1; mg/1
CII
RATE; DEXTROAMPHETAMINE SULFATE 1.875; 1.875; 1.875; 1.875 mg/1; mg/1; mg/1
[PE]" CII
CII
RATE; DEXTROAMPHETAMINE SULFATE 3.125; 3.125; 3.125; 3.125 mg/1; mg/1; mg/1
[PE]" CII
CII
RATE; DEXTROAMPHETAMINE SULFATE 5; 5; 5; 5 mg/1; mg/1; mg/1; mg/1 "Central
Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central
Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central N
ervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Ne
rvous System Stimulant [EPC],Central Nervous System Stimulation [PE]" CII
CII
0555-0775_a7ba6926-fcb6-4406-919c-290f2357934f 0555-0775 HUMAN PRESCRIPTI
s Inc. AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMIN
E SACCHARATE; DEXTROAMPHETAMINE SULFATE 1.875; 1.875; 1.875; 1.875 mg/1; mg
ulation [PE]" CII
E SACCHARATE; DEXTROAMPHETAMINE SULFATE 3.125; 3.125; 3.125; 3.125 mg/1; mg
ulation [PE]" CII
[PE]" CII
0555-0778_f8107ea5-6eef-4984-81eb-de3f7dc774f2 0555-0778 HUMAN PRESCRIPTI
ON DRUG Oxycodone Hydrochloride and Ibuprofen Oxycodone Hydrochloride
and Ibuprofen "TABLET, FILM COATED" ORAL 20071204 ANDA
ANDA078316 Barr Laboratories Inc. IBUPROFEN; OXYCODONE HYDROCHLORIDE
400; 5 mg/1; mg/1 "Full Opioid Agonists [MoA],Opioid Agonist [EPC],Cycloox
edient],Nonsteroidal Anti-inflammatory Drug [EPC]" CII
0555-0779_b5c4f918-796b-4542-976f-8166f3375771 0555-0779 HUMAN PRESCRIPTI
s Inc. MEDROXYPROGESTERONE ACETATE 10 mg/1 "Progesterone Congeners
[Chemical/Ingredient],Progestin [EPC]"
0555-0787_bfbaa52a-35c7-4b56-90c0-5bdff96bfc87 0555-0787 HUMAN PRESCRIPTI
Sulfate, and Amphetamine Sulfate" "Dextroamphetamine Saccharate, A
mphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate"
ENERIC NDA021303 Barr Laboratories Inc. AMPHETAMINE ASPARTATE MONOHYDRAT
5; 5; 5; 5 mg/1; mg/1; mg/1; mg/1 "Central Nervous System Stimulant [EPC],
Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],C
entral Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Ce
ntral Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Cen
tral Nervous System Stimulation [PE]" CII
0555-0808_394ef3ed-b93e-49d1-a9fa-1781f9f77019 0555-0808 HUMAN PRESCRIPTI
ON DRUG Tretinoin Tretinoin CAPSULE ORAL 20070626
ANDA ANDA077684 Barr Laboratories Inc. TRETINOIN 10 mg/1
0555-0831_5c275080-0a7d-40cb-9c7c-2b04e830a1e1 0555-0831 HUMAN PRESCRIPTI
ANDA ANDA040145 Barr Laboratories Inc. WARFARIN SODIUM 1 mg/1
"Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA]"
ANDA ANDA040145 Barr Laboratories Inc. WARFARIN SODIUM 2.5 mg/1
ANDA ANDA040145 Barr Laboratories Inc. WARFARIN SODIUM 7.5 mg/1
0555-0859_229f867f-d9cf-4298-bb19-dfb874fb5035 0555-0859 HUMAN PRESCRIPTI
20021118 ANDA ANDA075882 Barr Laboratories Inc. FLECAINI
DE ACETATE 50 mg/1 Antiarrhythmic [EPC]
s Inc. MEDROXYPROGESTERONE ACETATE 2.5 mg/1 "Progesterone Congeners
s Inc. MEDROXYPROGESTERONE ACETATE 5 mg/1 "Progesterone Congeners
0555-0877_1431e6ed-9e7b-4c10-9489-717c57f90d11 0555-0877 HUMAN PRESCRIPTI
ON DRUG Fluoxetine Fluoxetine hydrochloride CAPSULE ORAL
20010802 ANDA ANDA074803 Barr Laboratories Inc. FLUOXETI
NE HYDROCHLORIDE 20 mg/1 "Serotonin Reuptake Inhibitor [EPC],Sero
0555-0882_97cb0c06-808d-4638-a9ae-c958d8ba778f 0555-0882 HUMAN PRESCRIPTI
ON DRUG HYDROXYUREA Hydroxyurea CAPSULE ORAL 19981019
ANDA ANDA075143 Barr Laboratories Inc. HYDROXYUREA 500 mg/1
"Antimetabolite [EPC],Urea [Chemical/Ingredient]"
0555-0886_51f30bee-1653-4b61-bc3e-086106e144b4 0555-0886 HUMAN PRESCRIPTI
ANDA ANDA040197 Barr Laboratories Inc. ESTRADIOL 1 mg/1
"Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agon
ists [MoA]"
ANDA ANDA040197 Barr Laboratories Inc. ESTRADIOL 2 mg/1
ists [MoA]"
ANDA ANDA040197 Barr Laboratories Inc. ESTRADIOL 0.5 mg/1
ists [MoA]"
0555-0902_d3778189-a2c3-4a10-939a-dbc1d3df9499 0555-0902 HUMAN PRESCRIPTI
ON DRUG Naltrexone Hydrochloride Naltrexone Hydrochloride
Barr Laboratories Inc. NALTREXONE HYDROCHLORIDE 50 mg/1 "Opioid
Antagonist [EPC],Opioid Antagonists [MoA]"
0555-0923_6259f2b6-7a35-4a11-b5ab-b5d3df19ae84 0555-0923 HUMAN PRESCRIPTI
ON DRUG Ethambutol Hydrochloride Ethambutol Hydrochloride
Barr Laboratories Inc. ETHAMBUTOL HYDROCHLORIDE 400 mg/1 Antimyco
bacterial [EPC]
0555-0952_c8ac3d3d-4961-4904-9a6d-9b6ae254a978 0555-0952 HUMAN PRESCRIPTI
ON DRUG Dextroamphetamine Sulfate Dextroamphetamine Sulfate
s Inc. DEXTROAMPHETAMINE SULFATE 5 mg/1 "Central Nervous System
0555-0953_c8ac3d3d-4961-4904-9a6d-9b6ae254a978 0555-0953 HUMAN PRESCRIPTI
s Inc. DEXTROAMPHETAMINE SULFATE 10 mg/1 "Central Nervous System
0555-0954_d653c307-201c-4d22-ad60-c29fc6bee82a 0555-0954 HUMAN PRESCRIPTI
37 Barr Laboratories Inc. DEXTROAMPHETAMINE SULFATE 5 mg/1
CII
CII
CII
[PE]" CII
[PE]" CII
E SACCHARATE; DEXTROAMPHETAMINE SULFATE 5; 5; 5; 5 mg/1; mg/1; mg/1; mg/1
CII
[PE]" CII
0555-0997_a5365fc8-44fd-4872-83bb-342a7c18e5c7 0555-0997 HUMAN PRESCRIPTI
ON DRUG Fludrocortisone Acetate Fludrocortisone Acetate TABLET ORAL
20030214 ANDA ANDA040425 Barr Laboratories Inc. FLUDROCO
RTISONE ACETATE 0.1 mg/1
0555-1009_cfe78ca8-4b34-459c-9f44-26114a4649ac 0555-1009 HUMAN PRESCRIPTI
ON DRUG Clonidine Clonidine "PATCH, EXTENDED RELEASE"
TRANSDERMAL 20100825 ANDA ANDA079090 Barr Laboratorie
s Inc. CLONIDINE 0.1 mg/24h "Adrenergic alpha2-Agonists [MoA],Centra
ON DRUG Galantamine Hydrobromide Galantamine Hydrobromide
89 Barr Laboratories Inc. GALANTAMINE HYDROBROMIDE 8 mg/1
"Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]"
0555-1883_ded56918-ddc7-4d56-808d-4c16f5329abd 0555-1883 HUMAN PRESCRIPTI
ON DRUG Benzonatate Benzonatate CAPSULE ORAL 20080125
20150331 ANDA ANDA081297 Barr Laboratories Inc. BENZONATATE
200 mg/1 "Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-n
arcotic Antitussive [EPC]"
0555-9008_aef7feb4-3736-4ac6-9083-3962bd4b4a19 0555-9008 HUMAN PRESCRIPTI
ON DRUG Nortrel (28 Day Regimen) Norethindrone and Ethinyl Estradiol
KIT 20010606 ANDA ANDA072695 Barr Laboratorie
s Inc.
s Inc. ETHINYL ESTRADIOL; NORETHINDRONE .035; 1 mg/1; mg/1 "Progest
erone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Re
ceptor Agonists [MoA]"
s Inc.
0555-9012_800b819a-8592-4d99-bb2c-8b476026d058 0555-9012 HUMAN PRESCRIPTI
ON DRUG Nortrel 7/7/7 (28 Day Regimen) Norethindrone and Ethinyl Estrad
iol KIT 20030102 ANDA ANDA075478 Barr Lab
oratories Inc.
0555-9014_b83c9300-f9c6-47fa-a0f7-385b72d4c2d5 0555-9014 HUMAN PRESCRIPTI
ON DRUG Lessina levonorgestrel and ethinyl estradiol KIT
20020422 ANDA ANDA075803 Barr Laboratories Inc.
0555-9016_7b6681a8-8cef-4727-a6c7-33929829ac40 0555-9016 HUMAN PRESCRIPTI
ON DRUG Sprintec Norgestimate and Ethinyl Estradiol KIT
0555-9018_49794bb6-9894-411a-a448-339e292320fb 0555-9018 HUMAN PRESCRIPTI
ON DRUG Tri-Sprintec norgestimate and ethinyl estradiol KIT
0555-9020_2cec504a-7161-463d-b5c4-9e3cb9380eda 0555-9020 HUMAN PRESCRIPTI
ON DRUG Portia levonorgestrel and ethinyl estradiol KIT
0555-9025_ceddd4c3-4827-4294-8767-d1e781a1d611 0555-9025 HUMAN PRESCRIPTI
ON DRUG Junel 1/20 norethindrone acetate and ethinyl estradiol
s Inc. ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 20; 1 ug/1; mg/1
"Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Est
rogen Receptor Agonists [MoA]"
ON DRUG Junel Fe 1/20 "norethindrone acetate and ethinyl estradiol, an
d ferrous fumarate" KIT 20030918 ANDA ANDA0760
81 Barr Laboratories Inc.
ON DRUG Junel 1.5/30 norethindrone acetate and ethinyl estradiol
s Inc. ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 30; 1.5 ug/1; mg/1
"Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Est
rogen Receptor Agonists [MoA]"
ON DRUG Junel Fe 1.5/30 "norethindrone acetate and ethinyl estradiol, an
d ferrous fumarate" KIT 20030918 ANDA ANDA0760
64 Barr Laboratories Inc.
0555-9032_9d3f139b-7f5a-46ae-989d-adc73d5cf1c5 0555-9032 HUMAN PRESCRIPTI
ON DRUG Tri-Legest Fe 28 Day Norethindrone Acetate and Ethinyl Estradiol
s Inc.
0555-9034_c921e889-d7e1-412f-9e37-13bd31261095 0555-9034 HUMAN PRESCRIPTI
ON DRUG Balziva Norethindrone and Ethinyl Estradiol KIT
0555-9043_cce61fa1-95eb-467f-8641-bdc822d00d5d 0555-9043 HUMAN PRESCRIPTI
ON DRUG Apri Desogestrel and Ethinyl Estradiol KIT
0555-9045_dbe6ddbd-c46a-4162-9d96-4b516c1b44d7 0555-9045 HUMAN PRESCRIPTI
ON DRUG Aviane levonorgestrel and ethinyl estradiol KIT
0555-9047_cb57bd0a-f353-4560-af72-13d4256ec2a2 0555-9047 HUMAN PRESCRIPTI
ON DRUG Enpresse levonorgestrel and ethinyl estradiol KIT
0555-9049_143d035e-f885-4ca9-a37c-b43e26c65aeb 0555-9049 HUMAN PRESCRIPTI
ON DRUG Cryselle norgestrel and ethinyl estradiol KIT
0555-9050_68fbdcd4-f8e0-4a7f-8a49-c5e9dd7d3d14 0555-9050 HUMAN PRESCRIPTI
ON DRUG Kariva Desogestrel/Ethinyl Estradiol and Ethinyl Estradiol
s Inc.
0555-9051_450e3af9-143e-46ce-83fc-2e169cb49f72 0555-9051 HUMAN PRESCRIPTI
ON DRUG Velivet Triphasic Regimen Desogestrel and Ethinyl Estradiol
s Inc.
0555-9064_1f1de674-d5a8-49a2-bc68-d17adfb9db96 0555-9064 HUMAN PRESCRIPTI
ON DRUG Kelnor 1/35 ethynodiol diacetate and ethinyl estradiol
s Inc.
0555-9066_6363caa8-27b4-4b43-9e7d-7f8fbc3dd36d 0555-9066 HUMAN PRESCRIPTI
ON DRUG Aranelle norethindrone and ethinyl estradiol KIT
0555-9123_106a1084-010c-4f7d-ae63-5c6623e10a78 0555-9123 HUMAN PRESCRIPTI
ON DRUG Jolessa levonorgestrel / ethinyl estradiol KIT
20031013 NDA AUTHORIZED GENERIC NDA021544 Barr Laboratorie
s Inc.
0555-0513_9a0497ce-5c25-40ed-9e61-3a46940a71f0 0555-0513 HUMAN PRESCRIPTI
ON DRUG Acetazolamide Acetazolamide "CAPSULE, EXTENDED RELEASE"
ORAL 20000222 NDA NDA012945 Barr Laboratories Inc..
ACETAZOLAMIDE 500 mg/1 "Carbonic Anhydrase Inhibitor [EPC],Carbonic Anh
ydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient]"
0555-1054_ebabd195-9d21-4f9a-906f-eddfcb290c55 0555-1054 HUMAN PRESCRIPTI
ON DRUG Claravis isotretinoin CAPSULE ORAL 20030509
ANDA ANDA076356 "Barr Laboratories, Inc." ISOTRETINOIN 10
0555-9131_7ae51f8c-8ea0-4502-8d7b-d0c0b1a295ba 0555-9131 HUMAN PRESCRIPTI
ON DRUG OCELLA drospirenone and ethinyl estradiol KIT
20010611 NDA AUTHORIZED GENERIC NDA021098 "BARR LABORATORI
ES, INC."
62651-001_797a138c-6e8e-415a-aa92-3835dd058057 62651-001 HUMAN OTC DRUG
Unscented Hand Sanitizer ALCOHOL GEL TOPICAL 20140224
OTC MONOGRAPH NOT FINAL part333E Base4 Group Inc. ALCOHOL 62
mL/100mL
62651-002_92e00b5d-f82e-4432-9512-4c5b6af0500e 62651-002 HUMAN OTC DRUG
Vanilla Hand Sanitizer ALCOHOL GEL TOPICAL 20140224
OTC MONOGRAPH NOT FINAL part333E Base4 Group Inc. ALCOHOL 62
mL/100mL
75830-001_f14d2229-6671-4f15-aeb8-ace34ea3a0ea 75830-001 HUMAN OTC DRUG
Super Viragon "Bryonia Alba, Pulsatilla" LIQUID ORAL 20110701
20160101 UNAPPROVED HOMEOPATHIC Baseline Nutritionals Inc.
BRYONIA ALBA ROOT; PULSATILLA VULGARIS 30; 30 [hp_X]/59mL; [hp_X]/59mL
75830-002_8add58f8-4e01-4e29-921d-7d79ef73d0e7 75830-002 HUMAN OTC DRUG
KGP Flush "Berberis Vulgaris, Nux Vomica" LIQUID ORAL 20111101
UNAPPROVED HOMEOPATHIC Baseline Nutritionals Inc. BERBERIS VULGARI
S ROOT BARK; STRYCHNOS NUX-VOMICA SEED 6; 6 [hp_X]/118mL; [hp_X]/118mL
64786-233_d6be5945-cb41-4eef-a133-43cb0910936a 64786-233 HUMAN OTC DRUG
First Force TRICLOSAN SOAP TOPICAL 20110413
OTC MONOGRAPH NOT FINAL part333E Basic Packaging Industries Inc. TRICLOSA
N 0.1 g/100mL
61084-125_07c4fd76-cadb-4f6e-a4d1-e9288229c492 61084-125 HUMAN OTC DRUG
Emergency Zit Stick Acne Treatment Salicylic Acid STICK TOPICAL 20131105
OTC MONOGRAPH FINAL part358H Basic Research SALICYLIC ACID 2
g/2mL
61084-126_52f429fb-541b-4d2a-a110-fd9bc3e586c7 61084-126 HUMAN OTC DRUG
Clinical Emergency Zit Stick Acne Treatment Salicylic Acid STICK TOPICAL
20131105 OTC MONOGRAPH FINAL part358H Basic Research
SALICYLIC ACID 2 g/2mL
62670-1525_0bae134f-2bcc-4842-be2a-1ac735d6f982 62670-1525 HUMAN OTC DRUG
Signature Body Japanese Cherry Blossom SPF 15 "Avobenzone, Homosalate, Octisal
ate, Octocrylene, Oxybenzone" LOTION TOPICAL 20120507 OTC MONO
GRAPH NOT FINAL part352 "Bath & Body Works, Inc." AVOBENZONE; HOMOSALATE;
OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 9; 5; 5; 5 g/100g; g/100g; g/100g;
g/100g; g/100g
62670-1526_7a230629-b8f1-4c6b-a552-43ab38926c5b 62670-1526 HUMAN OTC DRUG
Signature Body Moonlight Path SPF 15 "Avobenzone, Homosalate, Octisalate, Oct
ocrylene, Oxybenzone" LOTION TOPICAL 20120507 OTC MONOGRAPH NO
T FINAL part352 "Bath & Body Works, Inc." AVOBENZONE; HOMOSALATE; OCTISALA
g/100g
62670-1527_b2189fd2-3ad8-478b-ae64-860334aa00f0 62670-1527 HUMAN OTC DRUG
Signature Body Sweet Pea SPF 15 "Avobenzone, Homosalate, Octisalate, Oct
g/100g
62670-1528_747aa169-0e1e-4f13-b6d4-4c0bc57ff84f 62670-1528 HUMAN OTC DRUG
Signature Body Twilight Woods SPF 15 "Avobenzone, Homosalate, Octisalate, Oct
g/100g
62670-1529_21bd50d8-c885-49c8-8a34-712f1b6310b5 62670-1529 HUMAN OTC DRUG
Signature Body White Citrus SPF 15 "Avobenzone, Homosalate, Octisalate, Oct
g/100g
62670-3571_96a816c4-eec4-4f4e-a78c-342eb77ec13c 62670-3571 HUMAN OTC DRUG
Anti-Bacterial Deep Cleansing Hand Gel Vanilla Bean Noel Alcohol GEL
TOPICAL 20091001 OTC MONOGRAPH NOT FINAL part333 "Bath & Body Wor
ks, Inc." ALCOHOL 60 g/100g
62670-3573_902b147e-338a-4932-86c7-cab02a44f931 62670-3573 HUMAN OTC DRUG
Anti-Bacterial Deep Cleansing Hand Gel Winter Candy Apple Alcohol GEL
ks, Inc." ALCOHOL 60 g/100g
62670-3635_368351d9-5b20-44da-87d9-63ff4e71f9cf 62670-3635 HUMAN OTC DRUG
Anti-Bacterial Hand Dancing Waters ALCOHOL GEL TOPICAL 20100101
OTC MONOGRAPH NOT FINAL part333E "Bath & Body Works, Inc." ALCOHOL
68 mL/100mL
62670-3636_19e69639-625d-4202-973f-8319eaa373e3 62670-3636 HUMAN OTC DRUG
Anti-Bacterial Hand Japanese Cherry Blossom ALCOHOL GEL TOPICAL 20100101
68 mL/100mL
62670-3640_7958ccc9-3586-479d-84b2-ba1e26fa6196 62670-3640 HUMAN OTC DRUG
Anti-Bacterial Hand Sweet Pea ALCOHOL GEL TOPICAL 20100101
68 mL/100mL
62670-3643_6f2ed26c-6478-496d-bb32-7994df3e3e7b 62670-3643 HUMAN OTC DRUG
Anti-Bacterial Hand Warm Vanilla Sugar ALCOHOL GEL TOPICAL 20100101
68 mL/100mL
62670-3649_2bec3077-df53-49a3-91c6-0521caff1307 62670-3649 HUMAN OTC DRUG
Anti-Bacterial Hand Foam Fresh Lemon ALCOHOL LIQUID TOPICAL 20100101
OTC MONOGRAPH NOT FINAL part333 "Bath & Body Works, Inc." ALCOHOL 69
mL/100mL
62670-3683_9e6320f1-73f1-40ab-86f5-044aff18393e 62670-3683 HUMAN OTC DRUG
Anti-Bacterial Hand G2G Grape ALCOHOL GEL TOPICAL 20100705
mL/100mL
62670-3715_b23e0e1f-f0fd-44f3-a653-0f2fbdef31b4 62670-3715 HUMAN OTC DRUG
Anti-Bacterial Hand Sanitizer Pure Vanilla Alcohol GEL TOPICAL 20100803
mL/100mL
62670-3716_eab8a94f-bdf2-4a8b-b7a4-911c64acab1a 62670-3716 HUMAN OTC DRUG
Anti-Bacterial Hand Sanitizer Twilight Woods Alcohol GEL TOPICAL 20100803
mL/100mL
62670-3754_2e5cd36b-3a89-4f62-a64a-32aeb519badb 62670-3754 HUMAN OTC DRUG
Anti-Bacterial Hand Spray Fresh Lemon ALCOHOL LIQUID TOPICAL 20101221
72 mL/100mL
62670-3755_b6f76f90-6080-4a4d-a28e-e445a80b657d 62670-3755 HUMAN OTC DRUG
Anti-Bacterial Hand Spray Sea Island Cotton ALCOHOL LIQUID TOPICAL
20101221 OTC MONOGRAPH NOT FINAL part333E "Bath & Body Wor
ks, Inc." ALCOHOL 72 mL/100mL
62670-3756_1e4a5a05-e8b8-40ae-b4b0-200f30dd691b 62670-3756 HUMAN OTC DRUG
Anti-Bacterial Hand Spray Sweet Pea ALCOHOL LIQUID TOPICAL 20101221
72 mL/100mL
62670-3757_d4e8ba6d-675f-4ee7-9af4-07ef56aec2bd 62670-3757 HUMAN OTC DRUG
Anti-Bacterial Hand Spray Warm Vanilla Sugar ALCOHOL LIQUID TOPICAL
62670-3914_eb4bb6bf-93e5-488e-b4e3-291e528f8378 62670-3914 HUMAN OTC DRUG
Anti-Bacterial Deep Cleansing Hand Mandarin Nectar Triclosan SOAP
TOPICAL 20110509 OTC MONOGRAPH NOT FINAL part333E "Bath &
Body Works, Inc." TRICLOSAN 3 mg/g
62670-3924_8c41cadd-da6c-4542-b442-7f93943f3bbb 62670-3924 HUMAN OTC DRUG
Anti-Bacterial Deep Cleansing Hand Citrus Crush Triclosan SOAP
62670-4078_bd7175db-b06e-44b7-8f26-660eac588a81 62670-4078 HUMAN OTC DRUG
Anti-Bacterial Hand Lemon Alcohol GEL TOPICAL 20110728
68 mL/100mL
62670-4158_dc495322-2d13-4d99-bf9c-d9ff7193fdc9 62670-4158 HUMAN OTC DRUG
Anti-Bacterial Gentle Foaming Hand Cranapple Crisp Triclosan SOAP
TOPICAL 20120330 20141114 OTC MONOGRAPH NOT FINAL part333E
"Bath & Body Works, Inc." TRICLOSAN 0.3 g/100mL
62670-4164_c7efd32d-889d-45bf-93fe-3c522cb828c1 62670-4164 HUMAN OTC DRUG
Anti-Bacterial Moisturizing Hand Pumpkin Caramel Latte Triclosan
SOAP TOPICAL 20120403 OTC MONOGRAPH NOT FINAL part333E
"Bath & Body Works, Inc." TRICLOSAN 3 mg/g
62670-4245_e04d43d3-4a97-46b2-b4b4-f19d84a37378 62670-4245 HUMAN OTC DRUG
Anti-Bacterial Gentle Foaming Hand Sour Patch Kids Triclosan SOAP
62670-4321_a761013c-0baf-445f-8e30-93e95bc9d298 62670-4321 HUMAN OTC DRUG
Anti-Bacterial Deep Cleansing Hand Papaya Melon Scoop Triclosan
62670-4339_7af9752f-9e0c-42f4-b1a5-6b1cffe588f0 62670-4339 HUMAN OTC DRUG
Anti-Bacterial Moisturizing Hand Fresh Picked Pomegranates Triclosa
n SOAP TOPICAL 20130215 OTC MONOGRAPH NOT FINAL part333E
62670-4358_fdea9963-fde2-4a07-85ce-67e16a2ce75d 62670-4358 HUMAN OTC DRUG
Anti-Bacterial Gentle Foaming Hand Orchard Walk Triclosan SOAP
62670-4359_80df395c-0f2c-40dd-be8c-bef48bdb0687 62670-4359 HUMAN OTC DRUG
Anti-Bacterial Gentle Foaming Hand I Heart Watermelon Cherry Triclosa
62670-4368_8817b124-8cd3-4b91-a5fa-08c3dae70508 62670-4368 HUMAN OTC DRUG
Anti-Bacterial Gentle Foaming Hand Cranberry Harvest Triclosan
62670-4369_5066f591-8ec7-4e96-9a5f-b34a9f03ab27 62670-4369 HUMAN OTC DRUG
Anti-Bacterial Gentle Foaming Hand Brewberry Triclosan SOAP
62670-4383_4da8ce10-3906-4385-b986-db99a21edc82 62670-4383 HUMAN OTC DRUG
Anti-Bacterial Gentle Foaming Hand Winter Spice Vanilla Triclosan
62670-4403_fc81ddce-1ff2-4f8b-8c94-4613ad0cb309 62670-4403 HUMAN OTC DRUG
Anti-Bacterial Deep Cleansing Hand Papaya Melon Scoop Triclosan
62670-4404_d4e5ad73-b911-462e-8e2c-55d2b901c416 62670-4404 HUMAN OTC DRUG
Anti-Bacterial Gentle Foaming Hand Paris Amour Triclosan SOAP
62670-4405_9025adf5-9e1d-4c13-91ab-8d22ae6cbc11 62670-4405 HUMAN OTC DRUG
Anti-Bacterial Gentle Foaming Hand Snow Frosted Apple Triclosan
62670-4406_b3f379b3-ddd8-4e08-8c53-6b04df25dd09 62670-4406 HUMAN OTC DRUG
Anti-Bacterial Gentle Foaming Hand Vampire Blood Triclosan SOAP
62670-4407_0834e0ff-4373-4616-b0de-052cbaab8cbf 62670-4407 HUMAN OTC DRUG
Anti-Bacterial Gentle Foaming Hand I Heart Watermelon Basil Triclosa
62670-4409_4ca4a4e1-faba-4b80-af64-b4edd4b97605 62670-4409 HUMAN OTC DRUG
Anti-Bacterial Gentle Foaming Hand Wild Honeysuckle Triclosan
62670-4458_3fe09d5b-1474-465d-80d9-9113e7ca4313 62670-4458 HUMAN OTC DRUG
Anti-Bacterial Moisturizing Hand Fresh Picked Apricots Triclosan
62670-4548_77f36089-c249-4a9f-a14b-91bffa201261 62670-4548 HUMAN OTC DRUG
Anti-Bacterial Hand Sanitizer Bella Flora Alcohol GEL TOPICAL 20130507
68 mL/100mL
62670-4562_18d03c27-6cda-4a3f-a39b-f7e993514676 62670-4562 HUMAN OTC DRUG
Anti-Bacterial Hand Sanitizer Japanese Cherry Blossom Alcohol GEL TOPICAL
62670-4563_68f72875-5609-4006-bd14-a45f8af6e890 62670-4563 HUMAN OTC DRUG
Anti-Bacterial Hand Sanitizer Sugar Lemon Fizz Alcohol GEL TOPICAL
62670-4564_245cff5b-e7b6-446b-9d32-b3680f7eebdb 62670-4564 HUMAN OTC DRUG
Anti-Bacterial Hand Sanitizer Summer Escape Alcohol GEL TOPICAL 20130515
68 mL/100mL
62670-4565_0834044d-3d4d-45c2-adec-5955bb398ebb 62670-4565 HUMAN OTC DRUG
Anti-Bacterial Hand Sanitizer Sweet Pea Alcohol GEL TOPICAL 20130515
68 mL/100mL
62670-4566_bb8c6231-d797-4203-9671-4820cef1d795 62670-4566 HUMAN OTC DRUG
Anti-Bacterial Hand Sanitizer Tuscan Vineyard Alcohol GEL TOPICAL 20130515
68 mL/100mL
62670-4569_c57bf4c2-c4c3-45b6-8a0e-067704764347 62670-4569 HUMAN OTC DRUG
Anti-Bacterial Hand Coconut Lime Verbena ALCOHOL SPRAY TOPICAL 20130604
72 mL/100mL
62670-4590_c0c76c20-c192-4644-9a53-d053e75caf84 62670-4590 HUMAN OTC DRUG
Anti-Bacterial Deep Cleansing Hand Fresh Picked Farmstand Apple Triclosa
62670-4591_c67bebbd-3c58-4628-b9bb-b825343bcc8f 62670-4591 HUMAN OTC DRUG
Anti-Bacterial Deep Cleansing Hand Fresh Picked Heirloom Cranberries
Triclosan SOAP TOPICAL 20120724 OTC MONOGRAPH NOT FINAL
part333E "Bath & Body Works, Inc." TRICLOSAN 3 mg/g
62670-4600_1827eb2f-65ec-4476-bcc4-c444b9dc9daf 62670-4600 HUMAN OTC DRUG
Anti-Bacterial Hand Sanitizer Fresh Strawberries Alcohol GEL TOPICAL
62670-8042_06fb849a-304a-4406-9c1f-cbb68cc7872b 62670-8042 HUMAN OTC DRUG
Patricia Wexler Skin Brightening Daily Moisturizer with Sunscreen Broad Spectrum
SPF 28 "Avobenzone, Octinoxate, Octisalate, Oxybenzone" LOTION
ks, Inc." AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 1.8; 7.5; 5; 2.4
g/100mL; g/100mL; g/100mL; g/100mL
62670-8043_14af5e69-d00b-411b-8274-df6eab3a49c3 62670-8043 HUMAN OTC DRUG
Patricia Wexler Universal Anti-Aging Moisturizer with Sunscreen Broad Spectrum S
PF 28 "Avobenzone, Octinoxate, Octisalate, Oxybenzone" LOTION
ks, Inc." AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 1.8; 7.5; 5; 2.4
g/100mL; g/100mL; g/100mL; g/100mL
62670-8045_e11ecd4c-2f66-4d34-afd0-cd858cbc1376 62670-8045 HUMAN OTC DRUG
Signature Sunscreen Broad Spectrum SPF 25 Malibu Heat "Avobenzone, Oct
inoxate, Oxybenzone" LOTION TOPICAL 20130909 OTC MONOGRAPH NO
T FINAL part352 "Bath & Body Works, Inc." AVOBENZONE; OCTINOXATE; OXYBENZO
NE 3; 7.5; 6 g/100mL; g/100mL; g/100mL
62670-8046_90ac3b6a-ce75-4a98-9d31-7a706b7572ad 62670-8046 HUMAN OTC DRUG
True Blue Spa Cooling Sunscreen Mist Broad Spectrum SPF 25 Water Resistant (40 m
inutes) Monoi Oil "Avobenzone, Homosalate, Octinoxate, Octisalate,
Octocrylene, Oxybenzone" "AEROSOL, SPRAY" TOPICAL 20130930
OTC MONOGRAPH NOT FINAL part352 "Bath & Body Works, Inc." AVOBENZONE; HOMO
SALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13.5; 7.5; 4.6; 2.4;
6 mg/g; mg/g; mg/g; mg/g; mg/g; mg/g
62670-8047_d855965d-f5bf-4334-99a1-2c6025dd7fb0 62670-8047 HUMAN OTC DRUG
Patricia Wexler Intensive 3-in-1 Day Cream with Sunscreen Broad Spectrum SPF 28
"Avobenzone, Octinoxate, Octisalate, Octocrylene, Oxybenzone" CREAM TOPICAL
20130930 OTC MONOGRAPH NOT FINAL part352 "Bath & Body Works, Inc.
" AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 7.5;
5; 2.7; 4 mg/g; mg/g; mg/g; mg/g; mg/g
69179-490_6036adcd-8611-43ae-94d0-119ea85b024a 69179-490 HUMAN OTC DRUG
HEM-EASY RELIEF Herbal Hemorrhoidal LIDOCAINE HYDROCHLORIDE CREAM
TOPICAL 20140820 OTC MONOGRAPH FINAL part346 "Batool Pharma I
nternational, Inc" LIDOCAINE 45 mg/mL
69179-491_6eff1d34-9b36-45c6-814a-e28a1fd6399e 69179-491 HUMAN OTC DRUG
HEM-EASY RELIEF Herbal Anti-Itch MAXIMUM ITCH RELIEF HYDROCORTISONE
CREAM TOPICAL 20140827 OTC MONOGRAPH NOT FINAL part348 "Batool
Pharma International, Inc" HYDROCORTISONE 10 mg/mL
24208-342_45294e89-b8c2-45d7-828f-70d97ab9ec86 24208-342 HUMAN PRESCRIPTI
ON DRUG Desmopressin Acetate Desmopressin Acetate SOLUTION
NASAL 19990125 ANDA ANDA074830 Bauch & Lomb Incorporate
d DESMOPRESSIN ACETATE 0.1 mg/mL "Factor VIII Activator [EPC],Inc
reased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII C
oncentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient]"
59759-557_9019cfc2-7ca3-41c3-9020-9a5c4a235630 59759-557 HUMAN OTC DRUG
SOFT SADDLE CHLOROXYLENOL SOAP TOPICAL 20140115
OTC MONOGRAPH NOT FINAL part333E BAUMANN PAPER COMPANY CHLOROXYLENOL
2.5 g/1000mL
24208-317_4dac0038-71cb-488e-9dd8-670fcf7b2073 24208-317 HUMAN PRESCRIPTI
ON DRUG Sulfacetamide Sodium and Prednisolone Sodium Phosphate Sulfacet
amide Sodium and Prednisolone Sodium Phosphate SOLUTION/ DROPS OPHTHALMIC
19951229 ANDA ANDA074449 Bausch & Lomb Incoporated
PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM 2.3; 100 mg/mL; m
g/mL "Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient],Cort
icosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]"
24208-631_55bcf205-bba5-4be3-993a-4a52e021b12c 24208-631 HUMAN PRESCRIPTI
n Sulfate, Polymyxin B Sulfate, Hydrocortisone" SOLUTION/ DROPS AURICULAR (OTIC)
19951229 ANDA ANDA064053 Bausch & Lomb Incoporated
HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 10; 3.5; 10000 mg/mL; m
g/mL; [USP'U]/mL "Aminoglycoside Antibacterial [EPC],Aminoglycosides [Che
24208-002_27d9b36d-20ff-4d98-bf19-c06679f7c341 24208-002 HUMAN PRESCRIPTI
ON DRUG VITRASE "hyaluronidase, ovine" "INJECTION, SOLUTION" SUBCUTAN
EOUS 20050201 NDA NDA021640 Bausch & Lomb Incorporat
ed "HYALURONIDASE, OVINE" 200 [USP'U]/mL "Endoglycosidase [EPC],G
lycoside Hydrolases [Chemical/Ingredient]"
24208-004_9a7f8feb-72b1-49e6-b0fc-267e0c8b8760 24208-004 HUMAN PRESCRIPTI
ON DRUG Istalol Timolol Maleate SOLUTION/ DROPS OPHTHALMIC 20040802
NDA NDA021516 Bausch & Lomb Incorporated TIMOLOL MALEATE 6.8
mg/mL "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]"
24208-070_7a963a34-2527-481f-bf18-c6eee8c54ad2 24208-070 HUMAN OTC DRUG
Eye Wash water SOLUTION OPHTHALMIC 20100831
OTC MONOGRAPH FINAL part349 Bausch & Lomb Incorporated WATER 99.05
mL/100mL
24208-073_c7daa870-8959-46ef-aa76-67607e8400bb 24208-073 HUMAN OTC DRUG
Colllyrium Eye Wash Water SOLUTION OPHTHALMIC 20100831
OTC MONOGRAPH FINAL part349 Bausch & Lomb Incorporated WATER 99.05
mL/100mL
24208-099_55b73bf4-9ba6-4e76-9db9-030f787793c3 24208-099 HUMAN PRESCRIPTI
ON DRUG Bromday bromfenac SOLUTION/ DROPS OPHTHALMIC 20100920
NDA NDA021664 Bausch & Lomb Incorporated BROMFENAC SODIUM
0.9 mg/mL "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory
24208-276_cc3d5bc8-9d3c-4c65-9e43-707a2db4081a 24208-276 HUMAN OTC DRUG
Muro 128 sodium chloride SOLUTION OPHTHALMIC 20110101
OTC MONOGRAPH FINAL part349 Bausch & Lomb Incorporated SODIUM CHLORIDE
20 mg/mL
24208-277_0ff44ba7-1e9f-435c-992d-ff735a8a14f8 24208-277 HUMAN OTC DRUG
Muro 128 sodium chloride SOLUTION OPHTHALMIC 20110101
50 mg/mL
24208-280_ee0bf442-2b50-4299-87fb-063d60df28e5 24208-280 HUMAN OTC DRUG
Murocel Methylcellulose SOLUTION/ DROPS OPHTHALMIC 20110504
OTC MONOGRAPH FINAL part349 Bausch & Lomb Incorporated METHYLCELLULOSE
(4000 CPS) 10 mg/15mL
24208-290_83292143-a4a4-49b9-a41b-aa492d9ba8d8 24208-290 HUMAN PRESCRIPTI
ON DRUG Tobramycin Tobramycin SOLUTION OPHTHALMIC
19931129 ANDA ANDA064052 Bausch & Lomb Incorporated
TOBRAMYCIN 3 mg/mL "Aminoglycoside Antibacterial [EPC],Aminoglycosi
24208-295_733c36b6-7b92-448c-be33-8beefcae990f 24208-295 HUMAN PRESCRIPTI
ON DRUG Tobramycin and Dexamethasone Tobramycin and Dexamethasone
SUSPENSION/ DROPS OPHTHALMIC 19991027 ANDA ANDA0641
34 Bausch & Lomb Incorporated DEXAMETHASONE; TOBRAMYCIN 1; 3
mg/mL; mg/mL "Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/In
gredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]"
24208-299_760eeae1-6004-4314-9b29-1f7d434714cf 24208-299 HUMAN PRESCRIPTI
ON DRUG LOTEMAX loteprednol etabonate SUSPENSION/ DROPS OPHTHALM
IC 19980309 NDA NDA020583 Bausch & Lomb Incorporat
ed LOTEPREDNOL ETABONATE 5 mg/mL "Corticosteroid [EPC],Corticoste
24208-300_56c00d32-a4ad-42ee-b964-e8e009dd1c4d 24208-300 HUMAN PRESCRIPTI
ON DRUG Crolom cromolyn sodium SOLUTION/ DROPS OPHTHALMIC 19950130
ANDA ANDA074443 Bausch & Lomb Incorporated CROMOLYN SODIUM 40
mg/mL "Decreased Histamine Release [PE],Mast Cell Stabilizer [EPC]"
24208-313_638d3c3f-9960-43da-956e-0e28c77f533e 24208-313 HUMAN OTC DRUG
Soothe Night Time white petrolatum mineral oil OINTMENT
OPHTHALMIC 20111115 OTC MONOGRAPH FINAL part349 Bausch &
Lomb Incorporated MINERAL OIL; PETROLATUM 200; 800 mg/g; mg/g
24208-314_8d90b181-36aa-4c80-8e43-ba6239d07c8e 24208-314 HUMAN PRESCRIPTI
ON DRUG Flurbiprofen Sodium Flurbiprofen Sodium SOLUTION/ DROPS
OPHTHALMIC 19950104 ANDA ANDA074447 Bausch & Lomb In
corporated FLURBIPROFEN SODIUM 0.3 mg/mL "Cyclooxygenase Inhibito
24208-315_697ea650-95b5-4814-8821-a99a85314679 24208-315 HUMAN PRESCRIPTI
ON DRUG Polymyxin B Sulfate and Trimethoprim Polymyxin B Sulfate and
Trimethoprim Sulfate SOLUTION/ DROPS OPHTHALMIC 19970214
ANDA ANDA064120 Bausch & Lomb Incorporated POLYMYXIN B SULFATE; TRI
METHOPRIM SULFATE 10000; 1 [USP'U]/mL; mg/mL "Polymyxin-class
Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Dihydrofolate Reductase In
hibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome
P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]"
24208-324_50847498-17a7-495b-80e1-00ef6c0028c2 24208-324 HUMAN PRESCRIPTI
TIMOLOL MALEATE 5 mg/mL
24208-330_50847498-17a7-495b-80e1-00ef6c0028c2 24208-330 HUMAN PRESCRIPTI
TIMOLOL MALEATE 2.5 mg/mL
24208-344_f2932169-353e-4db0-a534-d7cf6e247a27 24208-344 HUMAN PRESCRIPTI
ON DRUG Flunisolide Flunisolide SOLUTION NASAL 20020220
ANDA ANDA074805 Bausch & Lomb Incorporated FLUNISOLIDE 0.25
24208-347_01a90f37-30a7-4520-b4a7-1329af1ada02 24208-347 HUMAN PRESCRIPTI
Bausch & Lomb Incorporated ALBUTEROL SULFATE 5 mg/mL "Adrener
gic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]"
24208-349_ab7fb0b9-724c-4e03-af62-a467ac68dc9f 24208-349 HUMAN OTC DRUG
Advanced Eye Relief/ Redness Instant Relief Naphazoline Hydrochlorid
e and Polyethylene glycol 300 SOLUTION/ DROPS OPHTHALMIC 20100913
OTC MONOGRAPH FINAL part349 Bausch & Lomb Incorporated NAPHAZOLINE HYDR
OCHLORIDE; POLYETHYLENE GLYCOL 300 .1; 2 mg/mL; mg/mL
24208-353_4945f5c6-2df6-462a-b3d8-489928d205d0 24208-353 HUMAN PRESCRIPTI
ON DRUG ALREX loteprednol etabonate SUSPENSION/ DROPS OPHTHALM
ed LOTEPREDNOL ETABONATE 2 mg/mL "Corticosteroid [EPC],Corticoste
24208-358_36faa408-ab7c-4ae1-aef5-3860846aa0f6 24208-358 HUMAN PRESCRIPTI
ON DRUG Zylet loteprednol etabonate and tobramycin SUSPENSION/ DROP
S OPHTHALMIC 20041214 NDA NDA050804 Bausch &
Lomb Incorporated LOTEPREDNOL ETABONATE; TOBRAMYCIN 5; 3 mg/mL; m
g/mL "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Ami
noglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient]"
24208-367_cec44105-a602-4496-b61d-8eaad4e20b55 24208-367 HUMAN PRESCRIPTI
ON DRUG CARTEOLOL HYDROCHLORIDE CARTEOLOL HYDROCHLORIDE SOLUTION/ DROPS
corporated CARTEOLOL HYDROCHLORIDE 10 mg/mL "Adrenergic beta-Antagon
24208-385_a52f37e7-bf18-49ef-b9ee-f8d49b8a825d 24208-385 HUMAN OTC DRUG
Muro 128 sodium chloride OINTMENT OPHTHALMIC 20110101
50 mg/g
24208-398_3cfd35d6-9753-491d-868b-0532587df4a2 24208-398 HUMAN PRESCRIPTI
ON DRUG Ipratropium bromide Ipratropium bromide "SPRAY, METERED"
NASAL 20030331 ANDA ANDA076025 Bausch & Lomb Incorporat
ed IPRATROPIUM BROMIDE 21 ug/1 "Anticholinergic [EPC],Cholinerg
24208-399_d300e34c-7901-4e11-b66c-85d80aed286f 24208-399 HUMAN PRESCRIPTI
ON DRUG Ipratropium Bromide Ipratropium Bromide "SPRAY, METERED"
NASAL 20030331 ANDA ANDA076103 Bausch & Lomb Incorporat
ed IPRATROPIUM BROMIDE 42 ug/1 "Anticholinergic [EPC],Cholinerg
24208-410_568bf875-beda-4425-b175-decd86dcae12 24208-410 HUMAN PRESCRIPTI
ON DRUG Ofloxacin Ofloxacin SOLUTION AURICULAR (OTIC)
cal/Ingredient]"
24208-411_9992cdcd-fb1e-428b-9be6-75460a4257bf 24208-411 HUMAN PRESCRIPTI
ON DRUG Brimonidine Tartrate Brimonidine Tartrate SOLUTION/ DROPS
corporated BRIMONIDINE TARTRATE 2 mg/mL "Adrenergic alpha-Agonis
ts [MoA],alpha-Adrenergic Agonist [EPC]"
24208-416_4d40fe4c-3e8b-4c62-b9fe-6481e74f863f 24208-416 HUMAN PRESCRIPTI
ON DRUG Retisert Fluocinolone Acetonide IMPLANT INTRAVITREAL
20050408 NDA NDA021737 Bausch & Lomb Incorporated
FLUOCINOLONE ACETONIDE 0.59 mg/1 "Corticosteroid [EPC],Corticosteroid Hor
24208-430_ebe1add7-5213-430c-8668-963c470c7123 24208-430 HUMAN OTC DRUG
Opcon-A Naphazoline hydrochloride and Pheniramine maleate SOLUTION
/ DROPS OPHTHALMIC 19940608 NDA NDA020065 Bausch &
Lomb Incorporated NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE .2675; 3
.15 mg/mL; mg/mL
24208-433_9b6b900e-39c1-4746-a7e7-cb79b6339fcb 24208-433 HUMAN OTC DRUG
Soothe Hydration povidone SOLUTION OPHTHALMIC
20110502 OTC MONOGRAPH FINAL part349 Bausch & Lomb Incorporat
ed POVIDONE 12 mg/mL
24208-434_3665d266-c322-45b4-9e56-caa6035b092c 24208-434 HUMAN PRESCRIPTI
cal/Ingredient]"
24208-439_6ffca24c-7186-48ac-8a50-43bb646deacd 24208-439 HUMAN PRESCRIPTI
ON DRUG Bromfenac Bromfenac SOLUTION/ DROPS OPHTHALMIC
20131016 NDA AUTHORIZED GENERIC NDA021664 Bausch & Lomb In
corporated BROMFENAC SODIUM 0.9 mg/mL "Cyclooxygenase Inhibito
24208-443_f2d3e3bb-ed96-4ff6-a862-ed72973e4d0b 24208-443 HUMAN PRESCRIPTI
ON DRUG Lotemax loteprednol etabonate OINTMENT OPHTHALMIC
LOTEPREDNOL ETABONATE 5 mg/g "Corticosteroid [EPC],Corticosteroid Hor
24208-444_f105cf8b-a5b9-46a8-b22b-ba154d2b97d3 24208-444 HUMAN PRESCRIPTI
ON DRUG Ciprofloxacin Ciprofloxacin hydrochloride SOLUTION/ DROPS
corporated CIPROFLOXACIN HYDROCHLORIDE 3.5 mg/mL "Quinolone Antim
24208-446_115455ab-24e8-407f-a8b9-4eba551445d3 24208-446 HUMAN PRESCRIPTI
ON DRUG Besivance Besifloxacin SUSPENSION OPHTHALMIC
BESIFLOXACIN 6 mg/mL "Quinolone Antimicrobial [EPC],Quinolones [Chemi
cal/Ingredient]"
24208-450_3c11285a-7e86-4b47-b1ee-e7d59858087d 24208-450 HUMAN OTC DRUG
Advanced Eye Relief/ Redness Maximum Relief Naphazoline Hydrochlorid
e and Hypromellose SOLUTION/ DROPS OPHTHALMIC 20100902
OTC MONOGRAPH FINAL part349 Bausch & Lomb Incorporated HYPROMELLOSE; NA
PHAZOLINE HYDROCHLORIDE .3; 5 mg/mL; mg/mL
24208-453_a1d7ca31-8e46-49d2-991e-354a7bf397ac 24208-453 HUMAN OTC DRUG
Advanced Eye Relief/ Dry Eye/ Rejuvenation Lubricant propylene glycol
part349 Bausch & Lomb Incorporated PROPYLENE GLYCOL 0.95 mL/mL
24208-454_027969ee-64e4-4b08-bab7-c4cc8ed22f5f 24208-454 HUMAN OTC DRUG
Advanced Eye Relief Dry Eye Rejuvenation glycerin propylene glyco
l SOLUTION/ DROPS OPHTHALMIC 20100901 OTC MONOGRAPH FI
NAL part349 Bausch & Lomb Incorporated GLYCERIN; PROPYLENE GLYCOL
3; 10 mg/mL; mg/mL
24208-457_80dcc7ed-0b04-4cc7-a6e5-229f558ff4df 24208-457 HUMAN PRESCRIPTI
ON DRUG Diclofenac Sodium Diclofenac Sodium SOLUTION/ DROPS
corporated DICLOFENAC SODIUM 1 mg/mL "Cyclooxygenase Inhibito
24208-463_393a82f1-1957-424b-835d-b2ae48a1e1c0 24208-463 HUMAN PRESCRIPTI
ON DRUG Latanoprost Latanoprost SOLUTION/ DROPS OPHTHALMIC
LATANOPROST 50 ug/mL "Prostaglandin Analog [EPC],Prostaglandins [Chem
ical/Ingredient]"
24208-485_4825deb5-7717-4c19-a3e3-76c46b992e26 24208-485 HUMAN PRESCRIPTI
ON DRUG Dorzolamide HCl Dorzolamide HCl SOLUTION/ DROPS OPHTHALMIC
DORZOLAMIDE HYDROCHLORIDE 20 mg/mL "Carbonic Anhydrase Inhibitor [E
PC],Carbonic Anhydrase Inhibitors [MoA]"
24208-486_8311c675-7df1-4e87-b462-55ef8cfecab0 24208-486 HUMAN PRESCRIPTI
ON DRUG Dorzolamide HCl /Timolol Maleate Dorzolamide HCl /Timolol
Maleate SOLUTION/ DROPS OPHTHALMIC 20090714 ANDA
ANDA090037 Bausch & Lomb Incorporated DORZOLAMIDE HYDROCHLORIDE; TIMOL
OL MALEATE 20; 6.83 mg/mL; mg/mL "Carbonic Anhydrase Inhibitor [E
PC],Carbonic Anhydrase Inhibitors [MoA],Adrenergic beta-Antagonists [MoA],beta-A
drenergic Blocker [EPC]"
24208-495_09553092-32bd-46f1-ae57-39690d346285 24208-495 HUMAN OTC DRUG
Soothe glycerin and propylene glycol SOLUTION/ DROPS OPHTHALMIC
ed GLYCERIN; PROPYLENE GLYCOL 6; 6 mg/mL; mg/mL
24208-503_9a666065-d467-42b8-8ecd-0ec1de9986d5 24208-503 HUMAN PRESCRIPTI
ON DRUG LOTEMAX loteprednol etabonate GEL OPHTHALMIC 20121012
NDA NDA202872 Bausch & Lomb Incorporated LOTEPREDNOL ETABONATE
MoA]"
24208-505_371d1b92-5189-42bb-806f-6021eef34655 24208-505 HUMAN PRESCRIPTI
ON DRUG Levobunolol Hydrochloride Levobunolol Hydrochloride
Bausch & Lomb Incorporated LEVOBUNOLOL HYDROCHLORIDE 5 mg/mL
24208-535_227e3a76-311d-4dfd-8184-f81585d533c8 24208-535 HUMAN PRESCRIPTI
ON DRUG ZIRGAN ganciclovir GEL OPHTHALMIC 20100430
NDA NDA022211 Bausch & Lomb Incorporated GANCICLOVIR 1.5
mg/g "Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Po
lymerase Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Nucleoside Ana
log Antiviral [EPC]"
24208-539_d2d98a73-3056-4eb2-b8e8-9660403dcd0c 24208-539 HUMAN PRESCRIPTI
ON DRUG Miochol E acetylcholine chloride KIT 19930922
NDA NDA020213 Bausch & Lomb Incorporated
24208-544_30a388e9-b7e7-400d-8574-baf60a59375f 24208-544 HUMAN OTC DRUG
Soothe Long Lasting Povidone SOLUTION OPHTHALMIC
ed POVIDONES 20 mg/mL
24208-545_371d1b92-5189-42bb-806f-6021eef34655 24208-545 HUMAN PRESCRIPTI
ON DRUG Levobunolol Hydrochloride Levobunolol Hydrochloride
Bausch & Lomb Incorporated LEVOBUNOLOL HYDROCHLORIDE 2.5 mg/mL
24208-555_5cfad642-e7d0-4451-8bd4-29665208ac8d 24208-555 HUMAN PRESCRIPTI
ON DRUG Bacitracin Zinc and Polymyxin B Sulfate Bacitracin Zinc and Poly
myxin B Sulfate OINTMENT OPHTHALMIC 20080425 ANDA
ANDA064046 Bausch & Lomb Incorporated BACITRACIN ZINC; POLYMYXIN B SUL
FATE 500; 10000 [USP'U]/g; [USP'U]/g "Decreased Cell Wall Synthesis &
amp; Repair [PE],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingred
ient]"
24208-561_34ce556a-6aca-415e-9808-fd9646c1300a 24208-561 HUMAN PRESCRIPTI
OTHER Bausch & Lomb Incorporated ANTIPYRINE; BENZOCAINE 54; 14
24208-580_bde455c4-7557-48dd-aabe-621d8ed85d95 24208-580 HUMAN PRESCRIPTI
corporated GENTAMICIN SULFATE 3 mg/mL "Aminoglycoside Antibact
24208-585_1f4b97ea-4876-4d7f-acf3-ae07dd71b268 24208-585 HUMAN PRESCRIPTI
MoA]"
24208-590_1f4b97ea-4876-4d7f-acf3-ae07dd71b268 24208-590 HUMAN PRESCRIPTI
MoA]"
24208-601_ef9eebdd-8abd-4623-8eb1-dcf4b129ec77 24208-601 HUMAN OTC DRUG
Alaway Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 20061201
NDA NDA021996 Bausch & Lomb Incorporated KETOTIFEN FUMARATE
0.25 mg/mL
24208-602_4e072537-f73c-4a96-a65f-e2805ce112d8 24208-602 HUMAN PRESCRIPTI
ON DRUG Prolensa Bromfenac Sodium SOLUTION/ DROPS OPHTHALM
ed BROMFENAC SODIUM 0.7 mg/mL "Cyclooxygenase Inhibitors [MoA]
24208-615_54e19a39-60c6-4ce5-874f-d4122ba96279 24208-615 HUMAN PRESCRIPTI
ON DRUG Acetic Acid Acetic Acid SOLUTION/ DROPS AURICULAR (OTIC)
ACETIC ACID 2 mg/mL
24208-629_e8c7bd70-e024-4a70-81c9-0bf4a35e3b3c 24208-629 HUMAN PRESCRIPTI
ON DRUG Bepreve bepotastine besilate SOLUTION/ DROPS OPHTHALMIC
BEPOTASTINE BESILATE 15 mg/mL Histamine-1 Receptor Antagonist [EPC]
24208-635_a5f50a91-45db-4de0-8cfb-dfd33da7475f 24208-635 HUMAN PRESCRIPTI
n sulfate, Polymyxin B Sulfate and Hydrocortisone" SUSPENSION/ DROPS
AURICULAR (OTIC) 19960828 ANDA ANDA064065 Bausch &
Lomb Incorporated HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
10; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL "Corticosteroid [EPC],Corticoste
roid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminogly
cosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Ch
emical/Ingredient]"
24208-657_ab98750f-60c2-4c73-afee-97e4dcafb312 24208-657 HUMAN OTC DRUG
Soothe glycerin and propylene glycol SOLUTION/ DROPS OPHTHALMIC
ed GLYCERIN; PROPYLENE GLYCOL .55; .55 mg/mL; mg/mL
24208-670_983d205d-4212-44d9-98c5-3c5cf60cafa4 24208-670 HUMAN PRESCRIPTI
ON DRUG Sulfacetamide Sodium sulfacetamide sodium SOLUTION/ DROPS
corporated SULFACETAMIDE SODIUM 100 mg/mL "Sulfonamide Antibacteri
al [EPC],Sulfonamides [Chemical/Ingredient]"
24208-715_20e33e7f-db37-496e-8ff6-bc6b2068ca17 24208-715 HUMAN PRESCRIPTI
ON DRUG PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE
Bausch & Lomb Incorporated PREDNISOLONE SODIUM PHOSPHATE 10 mg/mL
24208-720_7559e7af-6ed2-4e5b-966d-4ee46c1ef545 24208-720 HUMAN PRESCRIPTI
Bausch & Lomb Incorporated DEXAMETHASONE SODIUM PHOSPHATE 1 mg/mL
24208-730_75f544ac-acf5-4a59-923a-e8040210977f 24208-730 HUMAN PRESCRIPTI
Bausch & Lomb Incorporated PROPARACAINE HYDROCHLORIDE 5 mg/mL
"Local Anesthesia [PE],Local Anesthetic [EPC]"
24208-732_1c5a620f-7083-4fee-99e2-c9380541c368 24208-732 HUMAN PRESCRIPTI
ON DRUG Fluorescein Sodium and Benoxinate Hydrochloride Fluorescein Sodi
um and Benoxinate Hydrochloride SOLUTION OPHTHALMIC 19950101
UNAPPROVED DRUG OTHER Bausch & Lomb Incorporated BENOXINATE HYDRO
CHLORIDE; FLUORESCEIN SODIUM 4; 2.5 mg/mL; mg/mL "Diagnostic Dye [EPC],Dy
es [MoA]"
24208-735_d847e475-16a2-4fc3-8f1f-e9c499fc50b4 24208-735 HUMAN PRESCRIPTI
Bausch & Lomb Incorporated CYCLOPENTOLATE HYDROCHLORIDE 10 mg/mL
24208-740_f0ca6986-74d1-40e8-af10-ce3de40be377 24208-740 HUMAN PRESCRIPTI
Bausch & Lomb Incorporated PHENYLEPHRINE HYDROCHLORIDE 25 mg/mL
"alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA]"
24208-750_37ace98a-994d-45fc-8241-c468abb4f7eb 24208-750 HUMAN PRESCRIPTI
ON DRUG Atropine Sulfate Atropine Sulfate SOLUTION
OPHTHALMIC 19900930 UNAPPROVED DRUG OTHER Bausch &
Lomb Incorporated ATROPINE SULFATE 10 mg/mL "Anticholinergic
24208-780_ab4612c6-3b08-44ba-8a43-b44e62aabbbc 24208-780 HUMAN PRESCRIPTI
ON DRUG Neomycin and Polymyxin B Sulfates and Bacitracin Zinc "Neomyci
n sulfate, Polymyxin B Sulfate and Bacitracin Zinc" OINTMENT OPHTHALM
IC 19951030 ANDA ANDA064064 Bausch & Lomb Incorporat
ed BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 10000
[USP'U]/g; mg/g; [USP'U]/g "Aminoglycoside Antibacterial [EPC],Aminoglycosi
al/Ingredient],Decreased Cell Wall Synthesis & Repair [PE]"
24208-785_b9cc175c-465e-4752-bd5f-cf56ba81b873 24208-785 HUMAN PRESCRIPTI
ON DRUG "Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and Hydrocortisone"
"Neomycin sulfate and Polymyxin B Sulfate, Bacitracin Zinc and Hydrocortisone"
Bausch & Lomb Incorporated BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFAT
E; POLYMYXIN B SULFATE 400; 10; 3.5; 10000 [USP'U]/g; mg/g; mg/g; [USP'U]/g
"Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymy
xin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wa
ll Synthesis & Repair [PE],Corticosteroid [EPC],Corticosteroid Hormone Recep
tor Agonists [MoA]"
24208-790_22ce5586-13cd-4b6b-abbd-17f6429ac062 24208-790 HUMAN PRESCRIPTI
ON DRUG NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN "neomyci
n sulfate, polymyxin b sulfate and gramicidin" SOLUTION/ DROPS OPHTHALMIC
GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE .025; 1.75; 10000
al/Ingredient]"
24208-795_5665f896-72a1-456d-a1f8-209978614c0a 24208-795 HUMAN PRESCRIPTI
ON DRUG Neomycin and Polymyxin B Sulfates and Dexamethasone "Neomyci
n Sulfate, Polymyxin B Sulfate, and Dexamethasone" OINTMENT OPHTHALM
ed DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 1; 3.5; 10000
mg/g; mg/g; [USP'U]/g "Aminoglycoside Antibacterial [EPC],Aminoglycosides [Che
24208-825_c0a56d60-0914-42b1-af59-c56afe93d18c 24208-825 HUMAN PRESCRIPTI
ON DRUG Atropine Sulfate Atropine Sulfate OINTMENT
OPHTHALMIC 19900930 UNAPPROVED DRUG OTHER Bausch &
Lomb Incorporated ATROPINE SULFATE 10 mg/g "Anticholinergic
24208-830_322c5da9-9ffc-4deb-9593-3437df10a662 24208-830 HUMAN PRESCRIPTI
ON DRUG Neomycin Polymyxin B Sulfates and Dexamethasone "Neomycin sulfat
e, Polymyxin B Sulfate and Dexamethasone" SUSPENSION/ DROPS OPHTHALM
ed DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 1; 3.5; 10000
al/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [Mo
A]"
24208-910_afcc9f01-dd91-468e-8f58-896b68c0d2ff 24208-910 HUMAN PRESCRIPTI
ERYTHROMYCIN 5 mg/g "Decreased Sebaceous Gland Activity [PE],Macroli
24208-920_c8476463-ad35-4d58-984b-064346ab6876 24208-920 HUMAN PRESCRIPTI
ON DRUG Tetracaine Hydrochloride Tetracaine Hydrochloride
Bausch & Lomb Incorporated TETRACAINE HYDROCHLORIDE 5 mg/mL
"Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE]
"
24208-960_3a6a88f2-8a00-4b46-a390-441e3cb89b3f 24208-960 HUMAN PRESCRIPTI
ON DRUG Nystatin Nystatin SUSPENSION ORAL 19940228
ANDA ANDA064042 Bausch & Lomb Incorporated NYSTATIN 100000
[USP'U]/mL "Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient]"
57782-397_feb9903f-0958-4e25-ae86-72098a33699c 57782-397 HUMAN OTC DRUG
Cromolyn Sodium Cromolyn Sodium "SPRAY, METERED" NASAL 20010703
ANDA ANDA075702 Bausch & Lomb Incorporated CROMOLYN SODIUM 5.2
mg/mL
24208-478_f23465b7-874b-4af3-82ba-b25da20bc9f8 24208-478 HUMAN OTC DRUG
Soothe TIRED EYES glycerin SOLUTION/ DROPS OPHTHALMIC
20120501 OTC MONOGRAPH FINAL part349 Baush & Lomb Incorporate
d GLYCERIN 10 mg/mL
24208-490_bdb32a2e-1a14-4b18-b9c9-592aff9c7cb8 24208-490 HUMAN OTC DRUG
Soothe XP light mineral oil and mineral oil SOLUTION/ DROPS
OPHTHALMIC 20100826 OTC MONOGRAPH FINAL part349 Baush &
Lomb Incorporated LIGHT MINERAL OIL; MINERAL OIL .15; .675 mL/15mL;
mL/15mL
0338-0013_b91257f8-2f69-48f2-b7eb-d59796e6e762 0338-0013 HUMAN PRESCRIPTI
19820630 NDA NDA018632 Baxter Healthcare Company
WATER 100 mL/100mL
0338-0013_c5ca76ea-aa7f-422e-8ec7-6e4e1cf5532c 0338-0013 HUMAN PRESCRIPTI
19820630 NDA NDA018632 Baxter Healthcare Company
WATER 100 mL/100mL
0338-0143_221f1e8e-fbef-4b8c-b091-83d8088cb6c4 0338-0143 HUMAN PRESCRIPTI
ON DRUG Dextrose and Electrolyte No. 48 "Sodium Lactate, Potassium Chlor
ide, Magnesium Chloride, Monobasic Potassium Phosphate, Sodium Chloride and Dext
rose monohydrate" "INJECTION, SOLUTION" INTRAVENOUS 19790202
NDA NDA017484 Baxter Healthcare Company "DEXTROSE MONOHYDRATE; M
AGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CH
LORIDE; SODIUM LACTATE" 5; 31; 141; 20; 12; 260 g/100mL; mg/100mL; mg/100mL; mg/
100mL; mg/100mL; mg/100mL "Potassium Compounds [Chemical/Ingredient],Potas
sium Salt [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity
[MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC]"
0338-0003_786205ff-9af2-4c4f-9d02-7622624a6b70 0338-0003 HUMAN PRESCRIPTI
ON DRUG Sterile Water Water IRRIGANT IRRIGATION 19800530
NDA NDA017866 Baxter Healthcare Corporation WATER 1 mL/mL
0338-0004_2ba47d77-e661-48e2-a844-a2447e94daeb 0338-0004 HUMAN PRESCRIPTI
ON DRUG STERILE WATER sterile water IRRIGANT IRRIGATION
19741231 NDA NDA017428 Baxter Healthcare Corporation
WATER 100 mL/100mL
0338-0017_3a79a5f9-07a9-4ab1-8f27-a3f25878b565 0338-0017 HUMAN PRESCRIPTI
ON DRUG DEXTROSE DEXTROSE MONOHYDRATE "INJECTION, SOLUTION"
INTRAVENOUS 19710304 NDA NDA016673 Baxter Healthcar
e Corporation DEXTROSE MONOHYDRATE 50 g/1000mL
0338-0023_3a79a5f9-07a9-4ab1-8f27-a3f25878b565 0338-0023 HUMAN PRESCRIPTI
ON DRUG DEXTROSE DEXTROSE MONOHYDRATE "INJECTION, SOLUTION"
0338-0031_4dbc4de6-a3f5-4650-8457-0d1fae7f0939 0338-0031 HUMAN PRESCRIPTI
ON DRUG DEXTROSE Dextrose monohydrate "INJECTION, SOLUTION"
0338-0043_2bb80001-5030-4579-9ebb-a17503e2d67f 0338-0043 HUMAN PRESCRIPTI
OUS 19790202 NDA NDA018016 Baxter Healthcare Corpor
ation SODIUM CHLORIDE 4.5 g/1000mL
0338-0047_98e57d52-39e9-46cf-81b6-c2f146cefbad 0338-0047 HUMAN PRESCRIPTI
ON DRUG Sodium Chloride Sodium Chlo

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