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Section 2.

Active Ingredients

Ingredient
NADA Trade Name Ingredients
(S) - methoprene
141-162 Hartz® Flea Control Capsules™ (S) - methoprene
Zodiac® Fleatrol Flea Caps™
2-Mercaptobenzothiazole
005-236 Sulfodene® Medication for Dogs 2-Mercaptobenzothiazole
Acepromazine Maleate
015-030 PromAce® Injectable Acepromazine Maleate
032-702 PromAce® Tablets Acepromazine Maleate
117-531 Acepromazine Maleate Injection Acepromazine Maleate
117-532 Acepromazine Maleate Tablets Acepromazine Maleate
200-319 Acepromazine Maleate Injection Acepromazine Maleate
200-361 Acepromazine Maleate Injection Acepromazine Maleate
Acetazolamide Sodium
011-582 Vetamox Soluble Powder Acetazolamide Sodium
Acetylsalicylic Acid
011-700 Cortaba® Tablets Acetylsalicylic Acid, Methylprednisolone
Aklomide
014-250 Novastat Type A Medicated Premix Aklomide, Sulfanitran
034-536 Aklomix Type A Medicated Article Aklomide, Roxarsone
Aklomix-3
034-537 Novastat-3 Type A Medicated Article Aklomide, Roxarsone, Sulfanitran
035-388 Novastat-W Aklomide, Sulfanitran
Albendazole
110-048 Valbazen® Albendazole
128-070 Valbazen® Albendazole
140-934 Valbazen® Albendazole
Albuterol Sulfate
141-180 T
orpex™ Albuterol Sulfate
Alfaprostol
130-092 A
lfavet™ Alfaprostol
Altrenogest
131-310 Regu-Mate® Altrenogest
141-222 Matrix™ Altrenogest
Amikacin Sulfate
127-892 Amiglyde-V Amikacin Sulfate
200-178 Amikacin Sulfate Injection Amikacin Sulfate
200-181 Amikacin Sulfate Solution Amikacin Sulfate
Aminopentamide Hydrogen Sulfate
043-078 Centrine Oral Tablets Aminopentamide Hydrogen Sulfate
043-079 Centrine Injectable Aminopentamide Hydrogen Sulfate
092-116 Ketaset® Plus Aminopentamide Hydrogen Sulfate, Ketamine
Hydrochloride, Promazine Hydrochloride
Aminopropazine Fumarate
011-877 Jenotone Tablets Aminopropazine Fumarate
013-181 Jenomycin Tablets Aminopropazine Fumarate, Neomycin Sulfate
034-477 Jenotone Solution Aminopropazine Fumarate
Amitraz
120-299 Mitaban® Liquid Concentrate Amitraz

January 15, 2008 FDA APPROVED ANIMAL DRUG PRODUCTS 2.1


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Ammonium Chloride
009-339 C
arafen Cough Syrup Ammonium Chloride, Caramiphen Edisylate
Carafen Cough Tablets
Amoxicillin Trihydrate
055-078 Amoxi-Tabs Amoxicillin Trihydrate
055-080 Amoxi-Doser Amoxicillin Trihydrate
055-081 Amoxi-Tabs Amoxicillin Trihydrate
055-085 Amoxi-Drop® Oral Suspension Amoxicillin Trihydrate
055-087 Amoxi-Bol Amoxicillin Trihydrate
055-088 Amoxi-Sol Amoxicillin Trihydrate
055-089 Amoxi-Inject (Cattle) Amoxicillin Trihydrate
055-091 Amoxi-Inject (Dogs and Cats) Amoxicillin Trihydrate
055-099 Clavamox® Tablets Amoxicillin Trihydrate, Clavulanate Potassium
055-100 Amoxi-Mast Amoxicillin Trihydrate
055-101 Clavamox® Drops Amoxicillin Trihydrate, Clavulanate Potassium
065-492 Biomox Amoxicillin Trihydrate
065-495 Biomox Amoxicillin Trihydrate
141-004 Robamox®-V Amoxicillin Trihydrate
141-005 Robamox®-V Tablets Amoxicillin Trihydrate
Amphomycin Calcium
043-784 Kanfosone Ointment Amphomycin Calcium, Hydrocortisone Acetate,
Kanamycin Sulfate
047-997 Amphoderm Ointment Amphomycin Calcium, Hydrocortisone Acetate,
Kanamycin Sulfate
Ampicillin Anhydrous
055-013 Omnipen 250 mg Ampicillin Anhydrous
Ampicillin Sodium
055-084 A
mp-Equine Ampicillin Sodium
Ampicillin Trihydrate
055-030 Polyflex® Ampicillin Trihydrate
055-036 Princillin Capsules 125 mg Ampicillin Trihydrate
Princillin Capsules 250 mg
Princillin Capsules 500 mg
055-042 Ampi-Tab Ampicillin Trihydrate
055-050 Princillin Soluble Powder Ampicillin Trihydrate
055-056 Princillin Bolus Ampicillin Trihydrate
055-061 Princillin "125" For Oral Suspension Ampicillin Trihydrate
055-064 Princillin Injection Ampicillin Trihydrate
055-066 Princillin Injection Ampicillin Trihydrate
055-071 Princillin Injection 200 mg Ampicillin Trihydrate
055-074 Ampi-Bol Ampicillin Trihydrate
055-079 Ampi-Ject Ampicillin Trihydrate
200-180 Ampicillin Trihydrate Ampicillin Trihydrate
Amprolium
012-350 Amprovine 25%, CORID® 25% Type A Medicated Article Amprolium
013-149 Amprovine 9.6% Solution Amprolium
013-461 Broiler PMX No.1620 Amprolium, Ethopabate, Roxarsone
013-663 Purina® Liquid Amprol Amprolium, Benzoic Acid
033-165 Amprovine 20% Soluble Powder, Corid 20% Soluble Powder Amprolium
036-304 Amprol HI-E® Plus Amprolium, Bacitracin Methylene Disalicylate,
Ethopabate

2.2 FDA APPROVED ANIMAL DRUG PRODUCTS January 15, 2008


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Amprolium, cont.
036-361 Amp Ethopabate CTC® Sodium Sulfate Amprolium, Chlortetracycline Calcium Complex,
Ethopabate, Sodium Sulfate
038-242 Erythro® (Low Lev) / Amp / Etho Amprolium, Arsanilic Acid, Erythromycin
Thiocyanate, Ethopabate
039-284 Swisher Super Broiler 300-108 Amprolium, Bacitracin Zinc, Ethopabate, Roxarsone
Swisher Super Broiler 400-112
040-920 Chick Grower-Developer Fortified Amprolium
041-178 Amprol® Plus / Lincomix® / Roxarsone Amprolium, Ethopabate, Lincomycin Hydrochloride
Monohydrate, Roxarsone
044-820 Lincomix® / Amprol Plus Amprolium, Ethopabate, Lincomycin Hydrochloride
Monohydrate
049-179 Amprol HI-E® / Roxarsone Amprolium, Ethopabate, Roxarsone
049-180 Amprol HI-E® / BMD® / Roxarsone Amprolium, Bacitracin Methylene Disalicylate,
Ethopabate, Roxarsone
095-543 Amprol HI-E® & Bambermycins Amprolium, Bambermycins, Ethopabate
Amprol HI-E® / Flavomycin®
095-547 3-Nitro® / Amprol HI-E® / Flavomycin® Amprolium, Bambermycins, Ethopabate, Roxarsone
095-548 3-Nitro® / Amprol / Flavomycin® Amprolium, Bambermycins, Roxarsone
095-549 3-Nitro® / Amprol / Flavomycin® Amprolium, Bambermycins, Ethopabate, Roxarsone
105-758 Amprol HI-E® / Baciferm® / 3-Nitro® Amprolium, Bacitracin Zinc, Ethopabate, Roxarsone
114-794 Baciferm® / Amprol HI-E® Premix Amprolium, Bacitracin Zinc, Ethopabate
118-507 Amprol® / Carb-O-Sep® Amprolium, Carbarsone
122-822 Amprol HI-E® / Stafac® Amprolium, Ethopabate, Virginiamycin
130-185 Flavomycin® / Amprolium Amprolium, Bambermycins
141-142 3-Nitro® / Amprol® / BMD® Amprolium, Bacitracin Methylene Disalicylate,
Roxarsone
141-156 Amprol® / BMD® Amprolium, Bacitracin Methylene Disalicylate
200-205 Albac® / Amprol Hi-E® Amprolium, Bacitracin Zinc, Ethopabate
200-214 3-Nitro® / Albac® / Amprol Hi-E® Amprolium, Bacitracin Zinc, Ethopabate, Roxarsone
200-217 3-Nitro® / Albac® / Amprol Hi-E® Amprolium, Bacitracin Zinc, Ethopabate, Roxarsone
200-389 Amprolium 9.6% Oral Solution Amprolium
Apramycin Sulfate
106-964 Apralan® Soluble Powder Apramycin Sulfate
126-050 Apralan® 75 Soluble Powder Apramycin Sulfate

Arsanilic Acid
008-019 Pro-Gen Plus Feed Supplement Arsanilic Acid
038-241 Erythro® (High Lev) / Zoalene / Arsanilic Acid Arsanilic Acid, Erythromycin Thiocyanate, Zoalene
038-242 Erythro® (Low Lev) / Amp / Etho Amprolium, Arsanilic Acid, Erythromycin
Thiocyanate, Ethopabate
038-624 Pro-Gallimycin-10 Arsanilic Acid, Erythromycin Thiocyanate
Arsenamide Sodium
006-623 Caparsolate Sodium Arsenamide Sodium
Atipamezole Hydrochloride
141-033 Antisedan® Atipamezole Hydrochloride
Atropine
013-248 Freed No. 10, Freed No. 25 Atropine, Trichlorfon
035-650 Dyrex Powder Atropine, Trichlorfon

January 15, 2008 FDA APPROVED ANIMAL DRUG PRODUCTS 2.3


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Attapulgite
042-548 Amforol® Suspension Attapulgite, Bismuth Subcarbonate, Kanamycin
Sulfate
042-841 Amforol® Veterinary Oral Tablets Attapulgite, Bismuth Subcarbonate, Kanamycin
Sulfate
Azaperone
115-732 Stresnil Injection Azaperone
Bacitracin Methylene Disalicylate
036-304 Amprol HI-E® Plus Amprolium, Bacitracin Methylene Disalicylate,
Ethopabate
039-646 Carb-O-Gain Bacitracin Methylene Disalicylate, Carbarsone
041-541 BMD® 15 / Coyden 25® Bacitracin Methylene Disalicylate, Clopidol,
Roxarsone
046-592 BMD® 10 Type A Medicated Article Bacitracin Methylene Disalicylate
BMD® 25 Type A Medicated Article
BMD® 30 Type A Medicated Article
BMD® 40 Type A Medicated Article
BMD® 45 Type A Medicated Article
BMD® 50 Type A Medicated Article
BMD® 60 Type A Medicated Article
BMD® 70 Type A Medicated Article
049-180 Amprol HI-E® / BMD® / Roxarsone Amprolium, Bacitracin Methylene Disalicylate,
Ethopabate, Roxarsone
049-463 Monensin / Bacitracin MD Bacitracin Methylene Disalicylate, Monensin Sodium
049-464 Monensin / Bacitracin / Roxarsone Bacitracin Methylene Disalicylate, Monensin,
Roxarsone
065-107 Entromycin Powder Bacitracin Methylene Disalicylate, Streptomycin
Sulfate
065-280 Soluble Fortracin Concentrate Bacitracin Methylene Disalicylate
065-470 BMD® Soluble Bacitracin Methylene Disalicylate
BMD® Soluble 50%
Solu-tracin 50
Solu-tracin 200
097-085 Bac MD / Robenz® Bacitracin Methylene Disalicylate, Robenidine
Hydrochloride
098-378 Nicarbazin / Bacitracin Premix Bacitracin Methylene Disalicylate, Nicarbazin
099-150 BMD® / Coyden 25® Bacitracin Methylene Disalicylate, Clopidol
107-996 Avatec® / Fortracin Premix Bacitracin Methylene Disalicylate, Lasalocid
116-082 3-Nitro® / Avatec® / BMD® Bacitracin Methylene Disalicylate, Lasalocid,
Roxarsone
116-088 3-Nitro® / BMD® / Coban® Bacitracin Methylene Disalicylate, Monensin
3-Nitro® / Coban® / Fortracin Sodium, Roxarsone
131-894 3-Nitro® / Avatec® / Fortracin Broiler Premix Bacitracin Methylene Disalicylate, Lasalocid,
Roxarsone
135-321 3-Nitro® / Bio-Cox® / BMD® Bacitracin Methylene Disalicylate, Roxarsone,
Salinomycin Sodium
135-746 Bio-Cox® / BMD® Bacitracin Methylene Disalicylate, Salinomycin
Sodium
138-456 Coban® / BMD® Bacitracin Methylene Disalicylate, Monensin Sodium
140-533 3-Nitro® / BMD® / Stenorol® Bacitracin Methylene Disalicylate, Halofuginone
Hydrobromide, Roxarsone
140-584 BMD / Stenorol® Bacitracin Methylene Disalicylate, Halofuginone
Hydrobromide

2.4 FDA APPROVED ANIMAL DRUG PRODUCTS January 15, 2008


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Bacitracin Methylene Disalicylate, cont.
140-852 3-Nitro® / BMD® / Monteban® Bacitracin Methylene Disalicylate, Narasin,
Roxarsone
140-853 BMD® / Monteban® Bacitracin Methylene Disalicylate, Narasin
140-919 BMD® / Stenorol® Bacitracin Methylene Disalicylate, Halofuginone
Hydrobromide
140-926 BMD® / Maxiban® Bacitracin Methylene Disalicylate, Narasin,
Nicarbazin
140-937 BMD® / Coban® Bacitracin Methylene Disalicylate, Monensin Sodium
141-058 3-Nitro® / Aviax™ / BMD® Bacitracin Methylene Disalicylate, Roxarsone,
Semduramicin Sodium
141-059 BMD® 10, 25, 30, 40, 50, 60, 75 / CTC® 50, 65, 70 Bacitracin Methylene Disalicylate, Chlortetracycline
BMD® 25, 30, 40, 50, 60, 75 / ChlorMax™®- 50, 60, 70,
MICRO-CTC® 100
141-065 Aviax™ / BMD® Bacitracin Methylene Disalicylate, Semduramicin
Sodium
141-085 BMD® / Zoamix® Bacitracin Methylene Disalicylate, Zoalene
141-088 BMD® / Histostat® Bacitracin Methylene Disalicylate, Nitarsone
141-097 BMD® / Ivomec® Premix for Swine Bacitracin Methylene Disalicylate, Ivermectin
141-100 3-Nitro® / BMD® / Deccox® Bacitracin Methylene Disalicylate, Decoquinate,
Roxarsone
141-102 BMD® / Deccox® Bacitracin Methylene Disalicylate, Decoquinate
141-112 3-Nitro® / BMD® / Maxiban® Bacitracin Methylene Disalicylate, Narasin,
Nicarbazin, Roxarsone
141-121 3-Nitro® / Bio-Cox® / BMD® Bacitracin Methylene Disalicylate, Roxarsone,
Salinomycin Sodium
141-124 BMD® / Maxiban® Bacitracin Methylene Disalicylate, Narasin,
Nicarbazin
141-136 Bio-Cox® / BMD® Bacitracin Methylene Disalicylate, Salinomycin
Sodium
141-138 3-Nitro® / BMD® / Coban® Bacitracin Methylene Disalicylate, Monensin,
Roxarsone
141-140 BMD® / Coban® Bacitracin Methylene Disalicylate, Monensin
141-142 3-Nitro® / Amprol® / BMD® Amprolium, Bacitracin Methylene Disalicylate,
Roxarsone
141-144 BMD® / Safe-Guard® Bacitracin Methylene Disalicylate, Fenbendazole
141-153 BMD® / Clinacox™ Bacitracin Methylene Disalicylate, Diclazuril
141-154 BMD® / Robenz® Bacitracin Methylene Disalicylate, Robenidine
Hydrochloride
141-155 3-Nitro® / BMD® / Robenz® Bacitracin Methylene Disalicylate, Robenidine
Hydrochloride, Roxarsone
141-156 Amprol® / BMD® Amprolium, Bacitracin Methylene Disalicylate
141-179 Avatec® / BMD® Bacitracin Methylene Disalicylate, Lasalocid
141-190 3-Nitro® / BMD® / Clinacox™ Bacitracin Methylene Disalicylate, Diclazuril,
Roxarsone
141-194 BMD® / Clincox® Bacitracin Methylene Disalicylate, Diclazuril
141-195 Clinacox™/ Flavomycin® Bacitracin Methylene Disalicylate, Diclazuril
200-081 3-Nitro® / BMD® / Sacox® Bacitracin Methylene Disalicylate, Roxarsone,
Salinomycin Sodium
200-082 BMD® / Sacox® Bacitracin Methylene Disalicylate, Salinomycin
Sodium
200-164 BMD® / Nicarmix 25® Bacitracin Methylene Disalicylate, Nicarbazin

January 15, 2008 FDA APPROVED ANIMAL DRUG PRODUCTS 2.5


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Bacitracin Methylene Disalicylate, cont.
200-242 BMD®-25, -30, -40, -50, -60, or -75 / Aureomycin® -50, -70, Bacitracin Methylene Disalicylate, Chlortetracycline
-80, -90 or -100 Calcium Complex
200-358 Pennchlor/ BMD Bacitracin Methylene Disalicylate, Chlortetracycline
Hydrochloride
Bacitracin Zinc
039-284 Swisher Super Broiler 300-108 Amprolium, Bacitracin Zinc, Ethopabate, Roxarsone
Swisher Super Broiler 400-112
044-016 Coyden 25® / Roxarsone / Bacitracin Zinc Bacitracin Zinc, Clopidol, Roxarsone
045-348 A lbac® / Deccox® Bacitracin Zinc, Decoquinate
Broiler Finisher Medicated
046-920 Baciferm® - 10 Bacitracin Zinc
Baciferm® - 25
Baciferm® - 40
Baciferm® - 50
047-933 Monensin / Zinc Bacitracin Premix Bacitracin Zinc, Monensin Sodium
049-934 Coyden 25® / Bacitracin Zinc Bacitracin Zinc, Clopidol
065-015 Bacitracin-Neomycin-Polymyxin with Hydrocortisone Bacitracin Zinc, Hydrocortisone Acetate, Neomycin
Acetate Ophthalmic Ointment Sulfate, Polymyxin B Sulfate
Vetropolycin HC Ophthalmic Ointment
065-016 Bac-Neo-Poly Ophthalmic Ointment Bacitracin Zinc, Neomycin Sulfate, Polymyxin B
Vetropolycin Ophthalmic Ointment Sulfate
065-114 Mycitracin® Sterile Ophthalmic Ointment Bacitracin Zinc, Neomycin Sulfate, Polymyxin B
Sulfate
065-313 Baciferm® Soluble 50 Bacitracin Zinc
065-476 Cortisporin Veterinary Ophthalmic Ointment Bacitracin Zinc, Hydrocortisone Acetate, Neomycin
Sulfate, Polymyxin B Sulfate
065-485 Neosporin Ophthalmic Ointment Bacitracin Zinc, Neomycin Sulfate, Polymyxin B
Sulfate
091-326 3-Nitro® / Deccox® / Albac® Bacitracin Zinc, Decoquinate, Roxarsone
096-933 Robenz® / Zn Bacitracin Bacitracin Zinc, Robenidine Hydrochloride
098-452 Albac® 50 Type A Medicated Article Bacitracin Zinc
105-758 Amprol HI-E® / Baciferm® / 3-Nitro® Amprolium, Bacitracin Zinc, Ethopabate, Roxarsone
114-794 Baciferm® / Amprol HI-E® Premix Amprolium, Bacitracin Zinc, Ethopabate
123-154 3-Nitro®-10 / Baciferm® / Coban® Premix Bacitracin Zinc, Monensin Sodium, Roxarsone
126-052 3-Nitro® / Avatec® / Baciferm® Bacitracin Zinc, Lasalocid, Roxarsone
134-830 Albac® / Coban® Bacitracin Zinc, Monensin Sodium
136-484 Baciferm® / Carb-O-Sep® Bacitracin Zinc, Carbarsone
137-536 3-Nitro® / Albac® / Bio-Cox® Bacitracin Zinc, Roxarsone, Salinomycin Sodium
138-703 3-Nitro® / Albac® / Coban® Bacitracin Zinc, Monensin Sodium, Roxarsone
139-190 3-Nitro® / Bio-Cox® / Baciferm® Bacitracin Zinc, Roxarsone, Salinomycin Sodium
139-235 Baciferm® / Bio-Cox® Bacitracin Zinc, Salinomycin Sodium
140-865 Baciferm® / Albac®, Baciferm® / Monteban® Bacitracin Zinc, Narasin
141-083 Avatec® / Baciferm® Bacitracin Zinc, Lasalocid
141-109 Avatec® / Baciferm® Bacitracin Zinc, Lasalocid
141-146 Nicarb® / Baciferm® Bacitracin Zinc, Nicarbazin
141-181 Avatec® / Albac® Bacitracin Zinc, Lasalocid
200-086 3-Nitro® / Albac® / Sacox® Bacitracin Zinc, Roxarsone, Salinomycin Sodium
200-089 Baciferm® / Sacox® Bacitracin Zinc, Salinomycin Sodium
200-143 3-Nitro® / Baciferm® / Sacox® Bacitracin Zinc, Roxarsone, Salinomycin Sodium
200-203 Albac® / Carb-O-Sep® Bacitracin Zinc, Carbarsone
200-204 Albac® / Bio-Cox® Bacitracin Zinc, Salinomycin Sodium

2.6 FDA APPROVED ANIMAL DRUG PRODUCTS January 15, 2008


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Bacitracin Zinc, cont.
200-205 Albac® / Amprol Hi-E® Amprolium, Bacitracin Zinc, Ethopabate
200-206 3-Nitro® / Albac® / Deccox® Bacitracin Zinc, Decoquinate, Roxarsone
200-207 3-Nitro® / Albac® / Coyden 25® Bacitracin Zinc, Clopidol, Roxarsone
200-208 Avatec® / 3-Nitro® / Albac® Bacitracin Zinc, Lasalocid, Roxarsone
200-209 3-Nitro® / Albac® / Sacox® Bacitracin Zinc, Roxarsone, Salinomycin Sodium
200-210 Albac® / Sacox® Bacitracin Zinc, Salinomycin Sodium
200-211 3-Nitro® / Albac® / Coban® Bacitracin Zinc, Monensin, Roxarsone
200-212 Albac® / Robenz® Bacitracin Zinc, Robenidine Hydrochloride
200-213 Albac® / Deccox® Bacitracin Zinc, Decoquinate
200-214 3-Nitro® / Albac® / Amprol Hi-E® Amprolium, Bacitracin Zinc, Ethopabate, Roxarsone
200-215 3-Nitro® / Albac® / Bio-Cox® Bacitracin Zinc, Roxarsone, Salinomycin Sodium
200-217 3-Nitro® / Albac® / Amprol Hi-E® Amprolium, Bacitracin Zinc, Ethopabate, Roxarsone
200-218 Albac® / Coyden 25® / Albac® Bacitracin Zinc, Clopidol
200-223 Albac® 50 Type A Medicated Article Bacitracin Zinc
Balsam Peru Oil
031-555 Trypzyme® Aerosol Balsam Peru Oil, Castor Oil, Trypsin
039-583 Granulex Aerosol Spray Balsam Peru Oil, Castor Oil, Trypsin
Bambermycins
044-759 Flavomycin® Type A Medicated Article Bambermycins
095-543 Amprol HI-E® & Bambermycins, Amprol HI-E® / Amprolium, Bambermycins, Ethopabate
Flavomycin®
095-547 3-Nitro® / Amprol HI-E® / Flavomycin® Amprolium, Bambermycins, Ethopabate, Roxarsone
095-548 3-Nitro® / Amprol / Flavomycin® Amprolium, Bambermycins, Roxarsone
095-549 3-Nitro® / Amprol / Flavomycin® Amprolium, Bambermycins, Ethopabate, Roxarsone
098-340 Flavomycin® / Monensin Bambermycins, Monensin Sodium
098-341 3-Nitro® / Coban® / Flavomycin® Bambermycins, Monensin, Roxarsone
101-628 3-Nitro® / Flavomycin® / Zoalene Bambermycins, Roxarsone, Zoalene
101-629 Flavomycin® / Zoalene Bambermycins, Zoalene
112-687 3-Nitro® / Avatec® / Flavomycin® Bambermycins, Lasalocid, Roxarsone
130-185 Flavomycin® / Amprolium Amprolium, Bambermycins
130-661 Carb-O-Sep / Flavomycin® Bambermycins, Carbarsone
131-413 Flavomycin® 0.4 Bambermycins
Flavomycin® 2
132-448 Flavomycin® Bambermycins
132-705 Flavomycin® Bambermycins
134-185 3-Nitro® / Bio-Cox® / Flavomycin® Bambermycins, Roxarsone, Salinomycin Sodium
134-284 Bio-Cox® / Flavomycin® Bambermycins, Salinomycin Sodium
137-483 Flavomycin® / Stenorol® Bambermycins, Halofuginone Hydrobromide
140-339 Flavomycin® Bambermycins, Nicarbazin
Nicarb®
140-843 3-Nitro® / Flavomycin® / Monteban® Bambermycins, Narasin, Roxarsone
140-845 Flavomycin® / Monteban® Bambermycins, Narasin
140-918 Flavomycin® / Stenorol® Bambermycins, Halofuginone Hydrobromide
140-942 Flavomycin® / Maxiban® Bambermycins, Narasin, Nicarbazin
141-034 Gainpro® Type A Medicated Article Bambermycins
141-129 Avatec® / Flavomycin® Bambermycins, Lasalocid
141-158 Clinacox™ / Flavomycin® Bambermycins, Diclazuril
200-080 3-Nitro® / Flavomycin® / Sacox® Bambermycins, Roxarsone, Salinomycin Sodium
200-083 Flavomycin® / Sacox® Bambermycins, Salinomycin Sodium

January 15, 2008 FDA APPROVED ANIMAL DRUG PRODUCTS 2.7


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Benzoic Acid
013-663 Purina® Liquid Amprol Amprolium, Benzoic Acid
Beta-aminopropionitrile
141-107 Bapten® For Injection Beta-aminopropionitrile
Betamethasone Acetate
034-010 Betavet Soluspan Suspension Betamethasone Acetate, Betamethasone Sodium
Phosphate
034-267 Gentocin® Durafilm Ophthalmic Solution Betamethasone Acetate, Gentamicin Sulfate
Betamethasone Dipropionate
049-185 Betasone Aqueous Suspension Betamethasone Dipropionate, Betamethasone Sodium
Phosphate
Betamethasone Sodium Phosphate
034-010 Betavet Soluspan Suspension Betamethasone Acetate, Betamethasone Sodium
Phosphate
049-185 Betasone Aqueous Suspension Betamethasone Dipropionate, Betamethasone Sodium
Phosphate
Betamethasone Valerate
046-821 Gentocin® Otic Solution Betamethasone Valerate, Gentamicin Sulfate
113-231 Topagen® Ointment Betamethasone Valerate, Gentamicin Sulfate
132-338 Gentocin® Topical Spray Betamethasone Valerate, Gentamicin Sulfate
140-896 Otomax® Betamethasone Valerate, Clotrimazole, Gentamicin
Sulfate
200-183 Gentavet® Otic Solution Betamethasone Valerate, Gentamicin Sulfate
200-188 Betagen™ Topical Spray Betamethasone Valerate, Gentamicin Sulfate
200-229 Tri-Otic Ointment Betamethasone Valerate, Clotrimazole, Gentamicin
Sulfate
200-283 Vetro-Max® Betamethasone Valerate, Clotrimazole, Gentamicin
Sulfate
200-287 GBC Ointment™ Betamethasone Valerate, Clotrimazole, Gentamicin
Sulfate
200-415 Gentamicin Sulfate Topical Spray Betamethasone Valerate, Gentamicin Sulfate
Bicyclohexylammonium Fumagillin
009-252 Fumidil B Bicyclohexylammonium Fumagillin
Bismuth Subcarbonate
042-548 Amforol® Suspension Attapulgite, Bismuth Subcarbonate, Kanamycin
Sulfate
042-841 Amforol® Veterinary Oral Tablets Attapulgite, Bismuth Subcarbonate, Kanamycin
Sulfate
Boldenone Undecylenate
034-705 Equipoise® Boldenone Undecylenate
Bovine Somatotropin (Sometribove Zinc)
140-872 Posilac 1 Step® Bovine Somatotropin (Sometribove Zinc)
Bunamidine Hydrochloride
035-016 Scolaban 400 Bunamidine Hydrochloride
Buquinolate
045-738 Lincomix® / Bonaid Buquinolate, Lincomycin Hydrochloride
Lincomycin / Buquinolate Monohydrate
Butacaine Sulfate
130-872 Nitrofurazone Anesthetic Dress. Butacaine Sulfate, Nitrofurazone

2.8 FDA APPROVED ANIMAL DRUG PRODUCTS January 15, 2008


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Butamisole Hydrochloride
104-184 Styquin Butamisole Hydrochloride
132-533 Styquin Parenteral 1.1% Butamisole Hydrochloride
Butorphanol Tartrate
102-990 Torbutrol® Injection Butorphanol Tartrate
103-390 Torbutrol® Tablets Butorphanol Tartrate
135-780 Torbugesic® Butorphanol Tartrate
141-047 Torbugesic-SA® Butorphanol Tartrate
200-239 Dolorex® Butorphanol Tartrate
200-322 Butorphanol Tartrate Injection Butorphanol Tartrate
200-408 Butorphanol Tartrate Injection Butorphanol Tartrate
Cambendazole
094-642 Camvet Suspension Horse Wormer Cambendazole
096-506 Camvet Horse Wormer Pellets Cambendazole
096-731 Camvet Horse Wormer Paste 45% Cambendazole
Caramiphen Edisylate
009-339 C
arafen Cough Syrup Ammonium Chloride, Caramiphen Edisylate
Carafen Cough Tablets
Carbadox
041-061 Mecadox® Premix 10 Carbadox
092-955 Banminth® / Mecadox® Carbadox, Pyrantel Tartrate
141-211 Mecadox® 10 / Terramycin® 50 Carbadox, Oxytetracycline Dihydrate
Mecadox® 10 / Terramycin® 100

Mecadox® 10 / Terramycin® 200

Carbarsone
010-285 Carb-O-Sep® Type A Medicated Article Carbarsone
038-879 Carb-O-Sep® / Zoamix® Carbarsone, Zoalene
039-646 Carb-O-Gain Bacitracin Methylene Disalicylate, Carbarsone
118-507 Amprol® / Carb-O-Sep® Amprolium, Carbarsone
130-661 Carb-O-Sep / Flavomycin® Bambermycins, Carbarsone
136-484 Baciferm® / Carb-O-Sep® Bacitracin Zinc, Carbarsone
200-203 Albac® / Carb-O-Sep® Bacitracin Zinc, Carbarsone
Carbomycin
032-946 Magna Terramycin® Soluble Powder Carbomycin, Oxytetracycline Hydrochloride
Carfentanil Citrate
139-633 Wildnil® Carfentanil Citrate
Carnidazole
139-879 C
arnidazole Carnidazole
Spartrix®
Carprofen
141-053 Rimadyl® Caplets for Dogs Carprofen
141-111 Rimadyl® Chewable Tablets Carprofen
141-199 Rimadyl® Injectable Carprofen
200-366 Novocox Caplets Carprofen
Castor Oil
031-555 Trypzyme® Aerosol Balsam Peru Oil, Castor Oil, Trypsin
039-583 Granulex Aerosol Spray Balsam Peru Oil, Castor Oil, Trypsin
Cefadroxil
119-688 Cefa-Tabs® Cefadroxil
140-684 Cefa-Drops® Cefadroxil

January 15, 2008 FDA APPROVED ANIMAL DRUG PRODUCTS 2.9


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Cefpodoxime proxetil
141-232 S
implicef™ Cefpodoxime proxetil
Ceftiofur Crystalline Free Acid
141-209 Excede™ Sterile Suspension Ceftiofur Crystalline Free Acid
141-235 Excede™ For Swine Ceftiofur Crystalline Free Acid
Ceftiofur Hydrochloride
140-890 Excenel Sterile Suspension Ceftiofur Hydrochloride
Excenel® RTU
Excenel® Sterile Powder
141-238 Spectramast™ LC Sterile Suspension Ceftiofur Hydrochloride
141-239 Spectramast™ DC Sterile Suspension Ceftiofur Hydrochloride

Ceftiofur Sodium
140-338 Naxcel® Sterile Powder Ceftiofur Sodium
Cephapirin Benzathine
108-114 C
efa-Dri® Cephapirin Benzathine
Tomorrow® Infusion
Cephapirin Sodium
097-222 Cefa-Lak® Cephapirin Sodium
Today® Intramammary Infusion
Chloral Hydrate
046-789 C
hloropent Chloral Hydrate, Magnesium Sulfate, Pentobarbital
Chloramphenicol
055-002 Tevcocin Chloramphenicol
055-034 Chlorasol Chloramphenicol
055-051 Chloromycetin Tablets 100 mg Chloramphenicol
Chloromycetin Tablets 250 mg
Chloromycetin Tablets 500 mg
055-052 Chlora-Tabs 100 Chloramphenicol
055-059 Viceton® Tablets Chloramphenicol
065-137 Amphicol-V Chloramphenicol
065-149 Chloromycetin Ophthalmic Ointment Chloramphenicol
065-150 Chloramphenicol Capsules Chloramphenicol
065-158 Chloricol Chloramphenicol
065-241 Mychel-Vet Capsules (50 mg) Chloramphenicol
065-259 Chlorasone Ophthalmic Ointment Chloramphenicol, Prednisolone Acetate
065-345 Chloramphenicol Capsules Chloramphenicol
065-460 Chloramphenicol 1% Ophthalmic Chloramphenicol
Vetrocloricin Ophthalmic Ointment
065-461 Anacetin Tablets Chloramphenicol
065-463 Mychel-Vet Injection Chloramphenicol
065-489 Mychel-Vet Tabs Chloramphenicol
065-491 Medichol Tablets Chloramphenicol
Chloramphenicol Palmitate
055-047 Chloromycetin Palmitate Oral Suspension Chloramphenicol Palmitate
Chlorhexidine Acetate
009-782 Nolvasan® Antiseptic Ointment Chlorhexidine Acetate
200-301 Privasan™ Antiseptic Ointment Chlorhexidine Acetate

2.10 FDA APPROVED ANIMAL DRUG PRODUCTS January 15, 2008


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Chlorhexidine Hydrochloride
009-809 Nolvasan® Cap-Tabs® Chlorhexidine Hydrochloride
010-434 Nolvasan® Suspension Chlorhexidine Hydrochloride
Chlorobutanol
006-983 A-H Injection Chlorobutanol, Doxylamine Succinate
Chloroquine Phosphate
141-245 Tributame™ Euthanasia Solution Chloroquine Phosphate, Embutramid, Lidocaine
Chlorothiazide
011-678 Diuril® Tablet Chlorothiazide
012-734 Diuril® Chlorothiazide
Chlorphenesin Carbamate
038-160 Maolate® Tablets Chlorphenesin Carbamate
Maolate® Veterinary
Chlortetracycline
048-761 Aureomycin® 50 Granular Chlortetracycline
Aureomycin® 90 Granular
Aureomycin® 100 Granular
Aureomycin® Type A Medicated Article
138-935 Chlortetracycline - 50 Chlortetracycline
Chlortetracycline - 60
Chlortetracycline - 70
Chlortetracycline - 80
Chlortetracycline - 100
Chlortetracycline - 100MR
Pennchlor™ 50
Pennchlor™ 50-G
Pennchlor™ 70
Pennchlor™ 80
Pennchlor™ 90
Pennchlor™ 100MR
141-059 BMD® 10, 25, 30, 40, 50, 60, 75 / CTC® 50, 65, 70 Bacitracin Methylene Disalicylate, Chlortetracycline
BMD® 25, 30, 40, 50, 60, 75 / ChlorMax™®- 50, 60, 70
MICRO-CTC® 100
141-147 Chloromax® / Deccox® Chlortetracycline, Decoquinate
141-185 Aureomycin® / Deccox® Chlortetracycline, Decoquinate
141-201 Aureomycin® / Cattlyst® Chlortetracycline, Laidlomycin Propionate Potassium
141-250 Aureomycin® / Bovatec® Chlortetracycline, Lasalocid
200-259 3-Nitro® / ChlorMax™ / Sacox® Chlortetracycline, Roxarsone, Salinomycin Sodium
200-260 3-Nitro® / Bio-Cox® / ChlorMax™ Chlortetracycline, Roxarsone, Salinomycin Sodium
200-261 Bio-Cox® / ChlorMax™ Chlortetracycline, Salinomycin Sodium
200-262 ChlorMax™ / Sacox® Chlortetracycline, Salinomycin Sodium
200-263 ChlorMax™ / Coban® Chlortetracycline, Monensin Sodium
200-314 Pennchlor S™ Chlortetracycline, Sulfamethazine
200-355 Pennchlor™ / Bio-Cox® / 3-Nitro® Chlortetracycline, Roxarsone, Salinomycin Sodium
200-359 Pennchlor™ / Deccox® Chlortetracycline, Decoquinate
Chlortetracycline Bisulfate
055-012 Aureomycin® Sulmet Soluble Powder Chlortetracycline Bisulfate, Sulfamethazine
055-020 Aureomycin® Soluble Powder Chlortetracycline Bisulfate
065-486 Chlortetracycline Bisulfate Soluble Powder Chlortetracycline Bisulfate

January 15, 2008 FDA APPROVED ANIMAL DRUG PRODUCTS 2.11


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Chlortetracycline Calcium Complex
035-688 Aureo S-P 250® Chlortetracycline Calcium Complex, Penicillin G
Aureomix 500 Procaine, Sulfamethazine
036-361 Amp Ethopabate CTC® Sodium Sulfate Amprolium, Chlortetracycline Calcium Complex,
Ethopabate, Sodium Sulfate
041-647 Aureomix S 700-A Chlortetracycline Calcium Complex, Sulfamethazine
041-648 Aureomix S 700-D Chlortetracycline Calcium Complex, Sulfamethazine
041-649 Aureomix S 700-G Chlortetracycline Calcium Complex, Sulfamethazine
041-650 Aureomix S 700-E Chlortetracycline Calcium Complex, Sulfamethazine
041-651 Aureomix S 700-F Chlortetracycline Calcium Complex, Sulfamethazine
041-652 Aureomix S 700-C-2 Chlortetracycline Calcium Complex, Sulfamethazine
041-653 Aureomix S 700-B Chlortetracycline Calcium Complex, Sulfamethazine
041-654 Aureomix S 700-H Chlortetracycline Calcium Complex, Sulfamethazine
046-209 Coyden 25® / CTC® Chlortetracycline Calcium Complex, Clopidol
048-480 Chloratet 50 Chlortetracycline Calcium Complex
049-287 Chlorachel™ 50 Chlortetracycline Calcium Complex
Pfichlor™ 50
Pfichlor™ 70
Pfichlor™ 100
091-668 Chlorachel™ 250 Swine / Pficlor SP 250 Chlortetracycline Calcium Complex, Penicillin G
ChlorMax™ / SP 1000 Procaine, Sulfamethazine
ChlorMax™ / SP 250
ChlorMax™ / SP 500
092-286 C LTC-10 Chlortetracycline Calcium Complex
CLTC-20
CLTC-30
CLTC-50
CLTC-50 MR
092-287 CLTC 70 Chlortetracycline Calcium Complex
CLTC 100 MR
092-507 Robenz® / Aureomycin® 500 Gm Chlortetracycline Calcium Complex, Robenidine
Hydrochloride
100-901 Pfichlor 100S Milk Replacer Type A Medicated Article Chlortetracycline Calcium Complex
138-934 Pennchlor SP 250 Chlortetracycline Calcium Complex, Penicillin G
Pennchlor SP 500 Procaine, Sulfamethazine
140-859 Aureomycin® / Bio-Cox® Chlortetracycline Calcium Complex, Salinomycin
Sodium
140-867 Aureomycin® / Bio-Cox® / 3-Nitro® Chlortetracycline Calcium Complex, Roxarsone,
Salinomycin Sodium
200-091 3-Nitro® / Aureomycin® / Sacox® Chlortetracycline Calcium Complex, Roxarsone,
Salinomycin Sodium
200-095 Aureomycin® / Sacox® Chlortetracycline Calcium Complex, Salinomycin
Sodium
200-167 Aureozol® 500 Granular Chlortetracycline Calcium Complex, Penicillin G
Procaine, Sulfathiazole
200-242 BMD®-25, -30, -40, -50, -60, or -75 / Aureomycin® -50, -70, Bacitracin Methylene Disalicylate, Chlortetracycline
-80, -90 or -100 Calcium Complex
Chlortetracycline Hydrochloride
035-805 Aureo S 700® Chlortetracycline Hydrochloride, Sulfamethazine
Aureomix S 700 Crumbles
Aureomix S 700 g
039-077 C SP™ 250 Chlortetracycline Hydrochloride, Penicillin G
CSP™ 500 Procaine, Sulfathiazole

2.12 FDA APPROVED ANIMAL DRUG PRODUCTS January 15, 2008


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Chlortetracycline Hydrochloride, cont.
045-444 ChlorMax™ / Deccox® Chlortetracycline Hydrochloride, Decoquinate
Decoquinate & Chlortetracycline
046-699 ChlorMax™ 10 Type A Medicated Article Chlortetracycline Hydrochloride
ChlorMax™ 50 Type A Medicated Article
ChlorMax™ 65 Type A Medicated Article
ChlorMax™ 70 Type A Medicated Article
ChlorMax™ 100 Type A Medicated Article
Micro CTC 100
055-018 Aureomycin® Tablets 25 mg Chlortetracycline Hydrochloride
055-039 Aureomycin® Soluble Oblets Chlortetracycline Hydrochloride
055-040 SF Mix 66 Chlortetracycline Hydrochloride
065-071 Aureomycin® Soluble Powder Chlortetracycline Hydrochloride
065-178 Fermycin Soluble Chlortetracycline Hydrochloride
065-222 Keet Life Chlortetracycline Hydrochloride
065-256 Chlortet-Soluble-O Chlortetracycline Hydrochloride
065-440 Aureomycin® Soluble Powder Concentrate Chlortetracycline Hydrochloride
065-480 Chlortetracycline Soluble Powder Chlortetracycline Hydrochloride
Scour-Pneumonia Antibiotic
065-481 Calf Scour Boluses Chlortetracycline Hydrochloride
Chlortetracycline Pneumonia
121-553 Aureomycin® / Coban® Chlortetracycline Hydrochloride, Monensin Sodium
141-011 Chlortetracycline / Denagard® 10 Premixes Chlortetracycline Hydrochloride, Tiamulin Hydrogen
Fumarate
200-140 Aureozol® Chlortetracycline Hydrochloride, Penicillin G
Procaine, Sulfathiazole
200-236 Chlortetracycline HCl Soluble Powder Chlortetracycline Hydrochloride
200-295 Pennchlor™ 64 Chlortetracycline Hydrochloride
200-354 Pennchlor™ / Coban® Chlortetracycline Hydrochloride, Monensin Sodium
200-356 Pennchlor™ / Denagard® Chlortetracycline Hydrochloride, Tiamulin Hydrogen
Fumarate
200-357 Pennchlor® / Bio-Cox® Chlortetracycline Hydrochloride, Salinomycin
Sodium
200-358 Pennchlor/ BMD Bacitracin Methylene Disalicylate, Chlortetracycline
Hydrochloride
Chorionic Gonadotropin
006-103 Follutein Veterinary Chorionic Gonadotropin
047-055 Chorionic Gonadotropin Injectable Chorionic Gonadotropin
100-840 Chorionic Gonadotropin For Injection Chorionic Gonadotropin
103-090 Chortropin Chorionic Gonadotropin
140-856 P.G. 600® Chorionic Gonadotropin, Serum Gonadotropin
140-927 Chorulon® Chorionic Gonadotropin
Chymotrypsin
040-322 Kymar Ointment Improved Chymotrypsin, Hydrocortisone Acetate, Neomycin
Palmitate, Trypsin
Citric Acid
125-961 e-Sorb
R Citric Acid, Dextrose, Glycine, Potassium Citrate,
Vy'trate Potassium Phosphate, Sodium Chloride
Clavulanate Potassium
055-099 Clavamox® Tablets Amoxicillin Trihydrate, Clavulanate Potassium
055-101 Clavamox® Drops Amoxicillin Trihydrate, Clavulanate Potassium

January 15, 2008 FDA APPROVED ANIMAL DRUG PRODUCTS 2.13


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Clenbuterol Hydrochloride
140-973 Ventipulmin® Syrup Clenbuterol Hydrochloride
Clindamycin Hydrochloride
120-161 Antirobe® Capsules Clindamycin Hydrochloride
135-940 Antirobe® Aquadrops Liquid Clindamycin Hydrochloride
200-193 Clindamycin Hydrochloride Oral Liquid Clindamycin Hydrochloride
200-291 Clinsol® Clindamycin Hydrochloride
200-298 Clindamycin Hydrochloride Capsules Clindamycin Hydrochloride
200-316 Clintabs® Clindamycin Hydrochloride
200-398 Clindamycin Hydrochloride Oral Drops Clindamycin Hydrochloride
Clomipramine Hydrochloride
141-120 Clomicalm® Tablets Clomipramine Hydrochloride
Clopidol
034-393 Coyden 25® Clopidol
Lerbek 25
040-264 Coyden 25® / 3-Nitro® Clopidol, Roxarsone
041-541 BMD® 15 / Coyden 25® Bacitracin Methylene Disalicylate, Clopidol,
Roxarsone
044-016 Coyden 25® / Roxarsone / Bacitracin Zinc Bacitracin Zinc, Clopidol, Roxarsone
044-972 Coyden® / Lincomix® Clopidol, Lincomycin Hydrochloride Monohydrate
046-209 Coyden 25® / CTC® Chlortetracycline Calcium Complex, Clopidol
049-934 Coyden 25® / Bacitracin Zinc Bacitracin Zinc, Clopidol
099-150 BMD® / Coyden 25® Bacitracin Methylene Disalicylate, Clopidol
200-207 3-Nitro® / Albac® / Coyden 25® Bacitracin Zinc, Clopidol, Roxarsone
200-218 Albac® / Coyden 25® / Albac® Bacitracin Zinc, Clopidol
Cloprostenol Sodium
113-645 Estrumate® Cloprostenol Sodium
200-310 estroPLAN™ Injection Cloprostenol Sodium
Clorsulon
136-742 Curatrem® Drench Clorsulon
Curatrem® Drench For Cattle
140-833 Ivomec® F Injection For Cattle Clorsulon, Ivermectin
Ivomec® Plus Injection For Cattle
200-436 Noromectin® Plus Clorsulon, Ivermectin
Clotrimazole
116-089 Veltrim 1% Dermatologic Cream Clotrimazole
140-896 Otomax® Betamethasone Valerate, Clotrimazole, Gentamicin
Sulfate
141-177 Mometamax™ Otic Suspension Clotrimazole, Gentamicin Sulfate, Mometasone
Furoate Monohydrate
200-229 Tri-Otic Ointment Betamethasone Valerate, Clotrimazole, Gentamicin
Sulfate
200-283 Vetro-Max® Betamethasone Valerate, Clotrimazole, Gentamicin
Sulfate
200-287 GBC Ointment™ Betamethasone Valerate, Clotrimazole, Gentamicin
Sulfate
Cloxacillin Benzathine
055-058 Dry-Clox® Cloxacillin Benzathine
Dry-Clox® Intramammary Infusion
055-068 Boviclox Cloxacillin Benzathine
055-069 Orbenin DC Cloxacillin Benzathine

2.14 FDA APPROVED ANIMAL DRUG PRODUCTS January 15, 2008


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Cloxacillin Sodium
055-070 Dariclox® Cloxacillin Sodium
Colistimethate Sodium
141-069 First Guard® Sterile Powder Colistimethate Sodium
Colloidal Ferric Oxide
011-644 Felac Colloidal Ferric Oxide
011-779 Purina® Pigemia 100 Colloidal Ferric Oxide
Competitive Exclusion Culture
141-101 Preempt™ Competitive Exclusion Culture
Copper Naphthenate
012-991 Kopertox® Copper Naphthenate
100-616 Horseshoer's Secret Thrush Treatment Aid Copper Naphthenate
200-304 Pritox™ Copper Naphthenate
Corticotropin
008-760 Adrenomone Corticotropin
140-583 ACTH Gel Corticotropin
Coumaphos
040-001 Meldane 2 Coumaphos
042-116 Purina® 6 Day Worm-Kill Feed Coumaphos
042-117 Purina® 6 Day Worm-Kill Concentrate Coumaphos
Cupric Glycinate
031-971 Cuprate Cupric Glycinate
Cuprimyxin
093-029 Unitop Topical 0.5% Cream Cuprimyxin
Cyclosporine
141-052 Optimmune® Cyclosporine
141-218 Atopica® Cyclosporine
Cythioate
033-342 Proban® Cythioate Tablets 30 mg Cythioate
033-606 Proban® Oral Liquid Cythioate
132-336 Proban® Oral Liquid Cythioate
132-337 Proban® Tablets Cythioate
Danofloxacin
141-207 A180® Sterile Antimicrobial Injectable Solution Danofloxacin
Decoquinate
039-417 Deccox® Type A Medicated Article Decoquinate
040-435 3-Nitro® / Deccox® Decoquinate, Roxarsone
045-348 Albac® / Deccox®, Broiler Finisher Medicated Bacitracin Zinc, Decoquinate
045-444 ChlorMax™ / Deccox®, Decoquinate & Chlortetracycline Chlortetracycline Hydrochloride, Decoquinate
047-261 Lincomix® / Deccox® Decoquinate, Lincomycin Hydrochloride
Monohydrate
047-262 Deccox® / Lincomycin, Decoquinate & Lincomycin Decoquinate, Lincomycin
091-326 3-Nitro® / Deccox® / Albac® Bacitracin Zinc, Decoquinate, Roxarsone
141-060 Deccox® - M Medicated Powder for Whole Milk Decoquinate
141-100 3-Nitro® / BMD® / Deccox® Bacitracin Methylene Disalicylate, Decoquinate,
Roxarsone
141-102 BMD® / Deccox® Bacitracin Methylene Disalicylate, Decoquinate
141-147 Chloromax® / Deccox® Chlortetracycline, Decoquinate
141-148 Deccox® / Rumensin® Decoquinate, Monensin Sodium
141-149 Deccox® / Rumensin® / Tylan® Decoquinate, Monensin, Tylosin

January 15, 2008 FDA APPROVED ANIMAL DRUG PRODUCTS 2.15


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Decoquinate, cont.
141-185 Aureomycin® / Deccox® Chlortetracycline, Decoquinate
200-206 3-Nitro® / Albac® / Deccox® Bacitracin Zinc, Decoquinate, Roxarsone
200-213 Albac® / Deccox® Bacitracin Zinc, Decoquinate
200-359 Pennchlor™ / Deccox® Chlortetracycline, Decoquinate
Deracoxib
141-203 D
eramaxx® Deracoxib
Deslorelin Acetate
141-044 Ovuplant™ Deslorelin Acetate
Desoxycorticosterone Pivalate
141-029 P
ercorten®-V Desoxycorticosterone Pivalate
Detomidine Hydrochloride
140-862 D
ormosedan™ Detomidine Hydrochloride
Dexamethasone
011-885 Azium® Tablets 0.25 mg Dexamethasone
011-901 Azium® Aqueous Suspension Veterinary Dexamethasone
012-559 Azium® Solution Dexamethasone
030-136 Naquasone® Bolus Dexamethasone, Trichlormethiazide
030-434 Azium® Powder Dexamethasone
030-435 Azium® Boluses 10 mg Dexamethasone
042-633 Tresaderm Dermatologic Solution Dexamethasone, Neomycin Sulfate, Thiabendazole
092-835 Azium® Oral Solution 2 mg Dexamethasone
095-218 Dexium™ Tablets Dexamethasone
099-606 Dexameth-A-Vet Injection Dexamethasone
099-607 Dexameth-A-Vet Dexamethasone
108-687 Pet Derm® III Tablets Dexamethasone
111-369 Dexamethasone Sterile Solution Dexamethasone
128-089 Zonometh Solution Dexamethasone
130-660 Dexachel Dexamethasone
200-108 Dexamethasone Solution Dexamethasone
200-312 Dexium™ Dexamethasone
200-324 Dexamethasone Injection Dexamethasone
Dexamethasone Sodium Phosphate
099-604 Dex-A-Vet Injection Dexamethasone Sodium Phosphate
099-605 Dex-A-Vet Injection Dexamethasone Sodium Phosphate
104-606 Dexamethasone Injection Dexamethasone Sodium Phosphate
123-815 Dexamethasone Sodium Phosphate Inj. Dexamethasone Sodium Phosphate
200-317 Dexium-SP™ Dexamethasone Sodium Phosphate
Dexamethasone-21-isonicotinate
093-600 V
oren® Suspension Dexamethasone-21-isonicotinate
Dexmedetomidine hydrochloride
141-267 Dexdomitor® Dexmedetomidine hydrochloride
Dextrose
125-961 e-Sorb
R Citric Acid, Dextrose, Glycine, Potassium Citrate,
Vy'trate Potassium Phosphate, Sodium Chloride
Diatrizoate Meglumine
091-192 Renografin®-76 Diatrizoate Meglumine, Diatrizoate Sodium
091-240 Renovist Diatrizoate Meglumine, Diatrizoate Sodium
091-327 Gastrografin® Diatrizoate Meglumine, Diatrizoate Sodium

2.16 FDA APPROVED ANIMAL DRUG PRODUCTS January 15, 2008


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Diatrizoate Sodium
091-192 Renografin®-76 Diatrizoate Meglumine, Diatrizoate Sodium
091-240 Renovist Diatrizoate Meglumine, Diatrizoate Sodium
091-327 Gastrografin® Diatrizoate Meglumine, Diatrizoate Sodium
Dibucaine Hydrochloride
128-967 Repose Euthanasia Solution Dibucaine Hydrochloride, Secobarbital Sodium
Dichlorophene
006-691 Vermiplex Dichlorophene, Toluene
007-829 Happy Jack Tapeworm Tablets Dichlorophene
048-010 Anaplex Caps Dichlorophene, Toluene
Canine and Feline Wormer Caps
095-333 Difolin No. 1 Capsules Dichlorophene, Toluene
Difolin No. 2.5 Capsules
Difolin No. 5 Capsules
Difolin No. 25 Capsules
Difolin No. 40 Capsules
101-497 Tiny Tiger™ Worming Capsules For Cats Dichlorophene, Toluene
Worming Capsules For Puppies, Small Dogs And Cats
101-498 L.K. Worming Capsules For Dogs Dichlorophene, Toluene
102-020 Tri-Plex Worm Capsules Dichlorophene, Toluene
102-942 Pulvex Multipurpose Worm Caps Dichlorophene, Toluene
103-953 Trivermicide Worm Capsules Dichlorophene, Toluene
107-189 Worm Capsules Dichlorophene, Toluene
117-688 Dichlorophene & Toluene Caps. Dichlorophene, Toluene
120-671 Pet-Worm-Caps Dichlorophene, Toluene
126-676 D & T Worm Capsules Dichlorophene, Toluene
140-850 Elite Dog & Cat Wormer Dichlorophene, Toluene
Dichlorvos
031-512 Atgard® Swine Wormer 5.4g Dichlorvos
Atgard® Swine Wormer 27 g
Atgard® V Swine Wormer 5.4 g
Atgard® V Swine Wormer 27 g
033-803 Task Dog Anthelmintic Dichlorvos
035-918 Equigard Dichlorvos
Verdisol
040-848 Atgard® C Swine Wormer Dichlorvos
043-606 Atgard® Swine Wormer Dichlorvos
Atgard® V Swine Wormer
048-237 Equigel Dichlorvos
048-271 Task® Tabs Dichlorvos
049-032 Atgard® C Premix 9.6% Dichlorvos
Diclazuril
140-951 Clinacox™ Diclazuril
141-090 Clinacox™ / Stafac® Diclazuril, Virginiamycin
141-153 BMD® / Clinacox™ Bacitracin Methylene Disalicylate, Diclazuril
141-158 Clinacox™ / Flavomycin® Bambermycins, Diclazuril
141-190 3-Nitro® / BMD® / Clinacox™ Bacitracin Methylene Disalicylate, Diclazuril,
Roxarsone
141-194 BMD® / Clincox® Bacitracin Methylene Disalicylate, Diclazuril
141-195 Clinacox™/ Flavomycin® Bacitracin Methylene Disalicylate, Diclazuril
141-223 Clinacox™ 3-Nitro® Diclazuril, Roxarsone
141-268 Protazil™ Diclazuril

January 15, 2008 FDA APPROVED ANIMAL DRUG PRODUCTS 2.17


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Diclofenac sodium
141-186 SURPASS™ Diclofenac sodium
Dicloxacillin Sodium Monohydrate
055-032 Dicloxin Capsules Dicloxacillin Sodium Monohydrate
Diethylcarbamazine Citrate
092-836 Diethylcarbamazine Citrate Tab. Diethylcarbamazine Citrate
Diro-Form
092-837 D.E.C.- Sol. Syrup Diethylcarbamazine Citrate
Nemacide Oral Syrup
093-512 Dirocide Tablets Diethylcarbamazine Citrate
100-689 Difil Syrup Diethylcarbamazine Citrate
100-690 Difil Tablets Diethylcarbamazine Citrate
104-493 Filaribits® Chewable Tablets Diethylcarbamazine Citrate
107-506 Carbam® Tablets Diethylcarbamazine Citrate
108-487 DEC Tabs 400 mg Diethylcarbamazine Citrate
108-863 DEC Chewable Tabs Diethylcarbamazine Citrate
118-032 Carbam® Palatabs® Diethylcarbamazine Citrate
120-326 Filban Chewable Wafers Diethylcarbamazine Citrate
123-116 Diethylcarbamazine Citrate Cap. Diethylcarbamazine Citrate
124-842 Filban Tablets Diethylcarbamazine Citrate
127-627 Nemacide Diethylcarbamazine Citrate
Nemacide-C
128-069 Nemacide Chewable Tablets Diethylcarbamazine Citrate
128-517 Pet-Dec Diethylcarbamazine Citrate
131-808 Dirocide Syrup Diethylcarbamazine Citrate
136-483 Filaribits® Plus Chewable Tablets Diethylcarbamazine Citrate, Oxibendazole
Difloxacin Hydrochloride
141-096 D
icural® Tablets Difloxacin Hydrochloride
Dihydrostreptomycin Sulfate
055-028 Quartermaster® Dry Cow Treatment Dihydrostreptomycin Sulfate, Penicillin G Procaine
055-097 Dry-Mast Dihydrostreptomycin Sulfate, Penicillin G Procaine
065-013 Dihydrostreptomycin Dihydrostreptomycin Sulfate
065-291 Dihydrostreptomycin Sulfate Dihydrostreptomycin Sulfate, Streptomycin Sulfate
065-483 Pfizer-Strep Dihydrostreptomycin Sulfate
Dimethyl Sulfoxide
032-168 Domoso® Solution Dimethyl Sulfoxide
045-512 Synotic® Otic Solution Dimethyl Sulfoxide, Fluocinolone Acetonide
047-334 Synsac Solution Dimethyl Sulfoxide, Fluocinolone Acetonide
047-925 Domoso® Gel Dimethyl Sulfoxide
Dinoprost Tromethamine
100-202 Prostin F2 Alpha® Sterile Solution Dinoprost Tromethamine
108-901 Lutalyse® Sterile Solution Dinoprost Tromethamine
200-253 Dinoprost Tromethamine Injection Dinoprost Tromethamine
ProstaMate™

ProstaMate™ Sterile Solution

Dipiperazine Sulfate
010-005 Pig Wormer, Wazine® Dipiperazine Sulfate, Piperazine Hydrochloride
Wazine-34
Diprenorphine Hydrochloride
047-870 M50-50 Diprenorphine, M99 Etorphine Diprenorphine Hydrochloride, Etorphine
Hydrochloride

2.18 FDA APPROVED ANIMAL DRUG PRODUCTS January 15, 2008


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Dirlotapide
141-260 S
lentrol™ Dirlotapide
Dithiazanine Iodide
011-531 Dizan Tablets Dithiazanine Iodide
011-674 Dizan Powder Dithiazanine Iodide
012-469 Dizan Suspension With Piperazine Dithiazanine Iodide, Piperazine Citrate
Doramectin
141-061 Dectomax® Injectable Solution Doramectin
Dectomax® Injectable Solution for Cattle and Swine
141-095 Dectomax® Pour-on Doramectin
Dectomax® Pour-on Solution
Dectomax® Pour-on Solution for Cattle
Doxapram Hydrochloride
034-879 Dopram®-V Injectable Doxapram Hydrochloride
200-435 Respiram™ Doxapram Hydrochloride
Doxycycline Hyclate
141-082 Doxirobe™ Gel Doxycycline Hyclate
HESKA™ Perioceutic™ Gel
HESKA™ Periodontal Disease Therapeutic
Doxylamine Succinate
006-602 A-H-Tablets 25 mg Doxylamine Succinate
A-H-Tablets 100 mg
006-983 A-H Injection Chlorobutanol, Doxylamine Succinate
Droperidol
030-438 Innovar®-Vet Injection Droperidol, Fentanyl Citrate
Efrotomycin
140-818 P
roducil® Efrotomycin
Producil® For Swine
Embutramid
141-245 Tributame™ Euthanasia Solution Chloroquine Phosphate, Embutramid, Lidocaine
Emodepside
141-275 P
rofender® Emodepside, Praziquantel
Enalapril Maleate
141-015 Enacard® Enalapril Maleate
Enacard® Tablets For Dogs
Enrofloxacin
140-441 Baytril® Antibacterial Tablets Enrofloxacin
Baytril® Taste Tabs™ Antibacterial Tablets
140-913 Baytril® Antibacterial Injectable Solution Enrofloxacin
141-068 Baytril® 100 Injectable Solution Enrofloxacin
141-176 Baytril® Otic Enrofloxacin, Silver Sulfadiazine
Eprinomectin
141-079 Ivomec® Eprinex® Pour-On for Beef and Dairy Cattle, Eprinomectin
Ivomec® Eprinex® Pour-On for Cattle
Epsiprantel
140-893 Cestex® Epsiprantel
Erythromycin
012-123 Erythro® - 100 Erythromycin
Erythro® - 200
Gallimycin® Injectable

January 15, 2008 FDA APPROVED ANIMAL DRUG PRODUCTS 2.19


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Erythromycin, cont.
035-455 Erythro®-36 Dry Erythromycin
Gallimycin®-36 Dry
035-456 Gallimycin®-36 Sterile Erythromycin
037-586 Erythromast 36 Erythromycin
101-690 Erythro®-100 Injection Erythromycin
Erythromycin Phosphate
035-157 Gallimycin® Poultry Formula Conentrate Erythromycin Phosphate
Erythromycin Thiocyanate
010-092 Gallimycin®-100P Erythromycin Thiocyanate
038-241 Erythro® (High Lev) / Zoalene / Arsanilic Acid Arsanilic Acid, Erythromycin Thiocyanate, Zoalene
038-242 Erythro® (Low Lev) / Amp / Etho Amprolium, Arsanilic Acid, Erythromycin
Thiocyanate, Ethopabate
038-624 Pro-Gallimycin-10 Arsanilic Acid, Erythromycin Thiocyanate
041-955 Erythromycin Medicated Premix Erythromycin Thiocyanate
Estradiol
118-123 Encore® (Compudose 400® ) Estradiol, Oxytetracycline
140-897 Revalor®-G Estradiol, Trenbolone Acetate
Revalor®-IS
Revalor®-S
140-992 Revalor®-200 Estradiol, Trenbolone Acetate
Revalor®-H
Revalor®-IH
141-269 Revalor-XS Estradiol, Trenbolone Acetate
200-221 Component® TE-G with Tylan® Estradiol, Trenbolone Acetate, Tylosin Tartrate
Component® TE-ID with Tylan®

Component® TE-IS

Component® TE-IS with Tylan®

Component® TE-S with Tylan®

200-346 Component® TE-200 Estradiol, Trenbolone Acetate, Tylosin Tartrate


Component® TE-200 with Tylan®
Component® TE-H
Component® TE-H with Tylan®
Component® TE-IH
200-367 Synovex® T40 Estradiol, Trenbolone Acetate
Synovex® T80
Synovex® T120
Estradiol Benzoate
009-576 Synovex®-C Estradiol Benzoate, Progesterone
Synovex®-S
011-427 Synovex®-H Estradiol Benzoate, Testosterone Propionate
110-315 Component® E-C with Tylan® Estradiol Benzoate, Progesterone, Tylosin Tartrate
Component® E-S with Tylan®
135-906 Component® E-H with Tylan® Estradiol Benzoate, Testosterone Propionate, Tylosin
Tartrate
141-043 Synovex® Choice Estradiol Benzoate, Trenbolone Acetate
Synovex® Plus
Estradiol Valerate
134-930 Syncro-Mate-B® Estradiol Valerate, Norgestomet

2.20 FDA APPROVED ANIMAL DRUG PRODUCTS January 15, 2008


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Ethopabate
013-461 Broiler PMX No.1620 Amprolium, Ethopabate, Roxarsone
036-304 Amprol HI-E® Plus Amprolium, Bacitracin Methylene Disalicylate,
Ethopabate
036-361 Amp Ethopabate CTC® Sodium Sulfate Amprolium, Chlortetracycline Calcium Complex,
Ethopabate, Sodium Sulfate
038-242 Erythro® (Low Lev) / Amp / Etho Amprolium, Arsanilic Acid, Erythromycin
Thiocyanate, Ethopabate
039-284 Swisher Super Broiler 300-108 Amprolium, Bacitracin Zinc, Ethopabate, Roxarsone
Swisher Super Broiler 400-112
041-178 Amprol® Plus / Lincomix® / Roxarsone Amprolium, Ethopabate, Lincomycin Hydrochloride
Monohydrate, Roxarsone
044-820 Lincomix® / Amprol Plus Amprolium, Ethopabate, Lincomycin Hydrochloride
Monohydrate
049-179 Amprol HI-E® / Roxarsone Amprolium, Ethopabate, Roxarsone
049-180 Amprol HI-E® / BMD® / Roxarsone Amprolium, Bacitracin Methylene Disalicylate,
Ethopabate, Roxarsone
095-543 Amprol HI-E® & Bambermycins Amprolium, Bambermycins, Ethopabate
Amprol HI-E® / Flavomycin®
095-547 3-Nitro® / Amprol HI-E® / Flavomycin® Amprolium, Bambermycins, Ethopabate, Roxarsone
095-549 3-Nitro® / Amprol / Flavomycin® Amprolium, Bambermycins, Ethopabate, Roxarsone
105-758 Amprol HI-E® / Baciferm® / 3-Nitro® Amprolium, Bacitracin Zinc, Ethopabate, Roxarsone
114-794 Baciferm® / Amprol HI-E® Premix Amprolium, Bacitracin Zinc, Ethopabate
122-822 Amprol HI-E® / Stafac® Amprolium, Ethopabate, Virginiamycin
200-205 Albac® / Amprol Hi-E® Amprolium, Bacitracin Zinc, Ethopabate
200-214 3-Nitro® / Albac® / Amprol Hi-E® Amprolium, Bacitracin Zinc, Ethopabate, Roxarsone
200-217 3-Nitro® / Albac® / Amprol Hi-E® Amprolium, Bacitracin Zinc, Ethopabate, Roxarsone
Ethylisobutrazine Hydrochloride
011-222 Diquel Tablet Ethylisobutrazine Hydrochloride
035-265 Diquel Solution Ethylisobutrazine Hydrochloride
Etodolac
141-108 EtoGesic® Etodolac
141-274 Etogesic®Injectable Etodolac
Etorphine Hydrochloride
047-870 M50-50 Diprenorphine, M99 Etorphine Diprenorphine Hydrochloride, Etorphine
Hydrochloride
Famphur
034-266 Famix Famphur Premix Famphur
034-697 Bo-Ana Famphur Cattle Insecticide Famphur
Warbex® Famphur Cattle Pour-on
043-215 Purina® Grub-Kill Famphur
139-858 Tramisol®-X-Tra Cattle Anthelmintic and Extoparasitic Famphur, Levamisole Resinate
Paste
Febantel
107-345 Cutter Paste Febantel
Rintal® Paste
107-346 Rintal® Suspension Febantel
133-953 Vercom Paste Anthelmintic Febantel, Praziquantel
140-912 Rintal® Tabs Anthelmintic Tablets Febantel
141-007 Drontal® Plus Broad Spectrum Anthelmintic Tablets Febantel, Praziquantel, Pyrantel Pamoate
Drontal® Plus Tablets
Drontal® Plus Taste Tabs®

January 15, 2008 FDA APPROVED ANIMAL DRUG PRODUCTS 2.21


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Fenbendazole
104-494 Panacur® Suspension 10% Fenbendazole
111-278 Panacur® Granules 22.2% Fenbendazole
120-648 Panacur® Paste Fenbendazole
Safe-Guard®
121-473 Panacur® Granules 22.2% (Rx) Fenbendazole
Panacure®-C (Rx)
Safe-Guard® Canine (OTC)
128-620 Panacur® (Rx) Fenbendazole
Panacur® 10% Suspension (Rx)
Safe-Guard® Suspension 10% (OTC)
131-675 Safe-Guard® Fenbendazole
Safe-Guard® Dewormer 20% Type A Medicated Article
Safe-Guard® Type A Medicated Article
132-872 Panacur® 10% Paste Fenbendazole
Safe-Guard® 10% Paste
136-116 Purina® Worm-A-Rest Litter Pack Fenbendazole
137-600 Safe-Guard® Type A Medicated Article Fenbendazole
139-189 Safe-Guard® Enproal Feedblocks Fenbendazole
140-954 Lincomix® Type A Medicated Article Fenbendazole, Lincomycin
Safe-Guard® Type A Medicated Article
141-144 BMD® / Safe-Guard® Bacitracin Methylene Disalicylate, Fenbendazole
Fenprostalene
128-549 Bovilene Fenprostalene
138-903 Porcilene® Solution Fenprostalene
Fentanyl Citrate
030-438 Innovar®-Vet Injection Droperidol, Fentanyl Citrate
Fenthion
034-641 Tiguvon Pour-On Cattle Insecticide Fenthion
047-138 Spotton 20% Ready-to-Use Cattle Insecticide Fenthion
132-789 Pro-Spot Solution Fenthion
Firocoxib
141-230 Previcox® Firocoxib
141-253 Equioxx® Oral Paste Firocoxib
Florfenicol
141-063 Nuflor® Injectable Solution Florfenicol
141-206 Nuflor® Concentrate Solution Florfenicol
141-246 Aquaflor® Type A Medicated Article Florfenicol
141-264 Nuflor® Florfenicol
Flumethasone
030-414 Flucort® Solution Flumethasone
030-415 Flucort® Tablets Flumethasone
036-211 Anaprime® Suspension Flumethasone
038-801 Anaprime® Ophthalmic Solution Flumethasone, Neomycin Sulfate, Polymyxin B
Sulfate
049-725 Anaprime® Opthakote Ophthalmic Flumethasone, Neomycin Sulfate, Polymyxin B
Sulfate
Flumethasone Acetate
036-212 Fluosmin Suspension Flumethasone Acetate

2.22 FDA APPROVED ANIMAL DRUG PRODUCTS January 15, 2008


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Flunixin Meglumine
101-479 Banamine® Injectable Solution Flunixin Meglumine
106-616 Banamine® Granules Flunixin Meglumine
137-409 Banamine® Paste Flunixin Meglumine
200-061 Flunixin Meglumine Injection Flunixin Meglumine
Flunixin Meglumine Solution
200-124 Flunixin Meglumine Flunixin Meglumine
Flunixin Meglumine Injection
200-142 Flunixin Meglumine Solution Flunixin Meglumine
200-308 Flunixin Injection Flunixin Meglumine
200-387 Flunazine™ Flunixin Meglumine
Fluocinolone Acetonide
015-151 Neo-synalar Cream Fluocinolone Acetonide, Neomycin Sulfate
015-152 Synalar® Cream Veterinary Fluocinolone Acetonide
015-298 Synalar® Solution Veterinary Fluocinolone Acetonide
045-512 Synotic® Otic Solution Dimethyl Sulfoxide, Fluocinolone Acetonide
047-334 Synsac Solution Dimethyl Sulfoxide, Fluocinolone Acetonide
Fluoxetine Hydrochloride
141-272 Reconcile® Fluoxetine Hydrochloride
Fluprostenol Sodium
111-529 Equimate® Fluprostenol Sodium
Flurogestone Acetate
034-601 Synchro-Mate® Flurogestone Acetate
Follicle Stimulating Hormone
009-505 F.S.H.-P Injectable Follicle Stimulating Hormone
141-014 Super-Ov® Follicle Stimulating Hormone
Fomepizole
141-075 Antizol-Vet® Fomepizole
Formalin
137-687 Formalin-F Formalin
140-831 Paracide-F Formalin
140-989 Parasite-S® Formalin
Furazolidone
032-319 Furox® Aerosol Powder Furazolidone
Topazone Aerosol Powder
111-104 Furall Furazolidone
Furosemide
034-478 Lasix® Injectable Solution Furosemide
Salix™ Injection 5%
034-621 Lasix® Tablets 50 mg Furosemide
Salix™ Tablets
045-188 Lasix® Packets Furosemide
102-380 Lasix® Syrup 1% Furosemide
118-550 Furos-A-Vet Furosemide
127-034 Disal® Injection Furosemide
129-034 Disal® Furosemide
131-538 Disal® Furosemide
200-293 Furosemide Injection 5% Furosemide
200-373 Furosemide Syrup 1% Furosemide
200-382 Furosemide Syrup 1% Furosemide

January 15, 2008 FDA APPROVED ANIMAL DRUG PRODUCTS 2.23


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Gelatin
006-281 Intragel Gelatin, Sodium Chloride
Gentamicin Sulfate
034-267 Gentocin® Durafilm Ophthalmic Solution Betamethasone Acetate, Gentamicin Sulfate
038-292 Gentocin® Solution Gentamicin Sulfate
046-724 Gentocin® Solution Gentamicin Sulfate
046-821 Gentocin® Otic Solution Betamethasone Valerate, Gentamicin Sulfate
047-486 Garasol® Injection Gentamicin Sulfate
091-191 Garacin® Oral Solution Gentamicin Sulfate
Gentocin® Oral Solution
092-523 Garasol® Solution Gentamicin Sulfate
098-989 Gentocin® Ophthalmic Ointment Gentamicin Sulfate
099-008 Gentocin® Ophthalmic Solution Gentamicin Sulfate
101-862 Garasol® Injection Gentamicin Sulfate
103-037 Garacin® Piglet Injection Gentamicin Sulfate
113-231 Topagen® Ointment Betamethasone Valerate, Gentamicin Sulfate
130-464 Gentocin® (Garacin) Pig Pump Oral Solution Gentamicin Sulfate
130-952 Gentocin® Pink Eye Spray Gentamicin Sulfate
132-338 Gentocin® Topical Spray Betamethasone Valerate, Gentamicin Sulfate
133-836 Garacin® Soluble Powder Gentamicin Sulfate
Gentocin® (Garacin) Soluble Powder
137-310 Gentamicin Sulfate Inj. Sol. Gentamicin Sulfate
140-896 Otomax® Betamethasone Valerate, Clotrimazole, Gentamicin
Sulfate
141-177 Mometamax™ Otic Suspension Clotrimazole, Gentamicin Sulfate, Mometasone
Furoate Monohydrate
200-023 Gentamicin Sulfate Solution 100 mg/ml Gentamicin Sulfate
200-037 Gentamicin Sulfate Solution Gentamicin Sulfate
Legacy Sterile Solution
200-102 Gentaglyde™ Solution Gentamicin Sulfate
200-115 Gentamex™ 100 Gentamicin Sulfate
200-137 Gentamicin Sulfate Solution Gentamicin Sulfate
200-147 Genta-Ject® Gentamicin Sulfate
Gentamicin Sulfate Injection
200-174 Gentamicin Sulfate Pig Pump Oral Solution Gentamicin Sulfate
200-183 Gentavet® Otic Solution Betamethasone Valerate, Gentamicin Sulfate
200-185 Gen-Gard™ Soluble Powder Gentamicin Sulfate
200-188 Betagen™ Topical Spray Betamethasone Valerate, Gentamicin Sulfate
200-190 Gentoral® Gentamicin Sulfate
200-191 Gentasol Gentamicin Sulfate
200-229 Tri-Otic Ointment Betamethasone Valerate, Clotrimazole, Gentamicin
Sulfate
200-273 Vetro-Gen™ Veterinary Ophthalmic Ointment Gentamicin Sulfate
200-283 Vetro-Max® Betamethasone Valerate, Clotrimazole, Gentamicin
Sulfate
200-287 GBC Ointment™ Betamethasone Valerate, Clotrimazole, Gentamicin
Sulfate
200-394 Gentamicin Piglet Injection Gentamicin Sulfate
200-395 Gentamicin Sulfate Solution Gentamicin Sulfate
200-415 Gentamicin Sulfate Topical Spray Betamethasone Valerate, Gentamicin Sulfate

2.24 FDA APPROVED ANIMAL DRUG PRODUCTS January 15, 2008


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Gleptoferron
110-399 Gleptosil Gleptoferron
Heptomer Injection
Glycine
125-961 e-Sorb
R Citric Acid, Dextrose, Glycine, Potassium Citrate,
Vy'trate Potassium Phosphate, Sodium Chloride
Glycopyrrolate
101-777 Robinul®-V Injectable Glycopyrrolate
200-365 Glycopyrrolate Injectable Glycopyrrolate
Gonadorelin Diacetate Tetrahydrate
098-379 Cystorelin Gonadorelin Diacetate Tetrahydrate
200-069 OvaCyst™ Gonadorelin Diacetate Tetrahydrate
200-134 Fertagyl® Gonadorelin Diacetate Tetrahydrate
Gonadorelin Hydrochloride
139-237 F
actrel® Gonadorelin Hydrochloride
Griseofulvin
012-227 Fulvicin U/F® Tablets Griseofulvin
013-755 Grysio (Microsize) Griseofulvin
031-447 Fulvicin U/F® Bolus Veterinary Griseofulvin
039-792 Fulvicin U/F® Powder Griseofulvin
200-391 Griseofulvin Powder Griseofulvin
Guaifenesin
044-012 Gecolate Guaifenesin
048-854 Gecolate Guaifenesin
Glycodex Injection
136-651 Guailaxin Guaifenesin
200-230 Guaifenesin Injection Guaifenesin
Halofuginone Hydrobromide
130-951 Stenorol® Halofuginone Hydrobromide
137-483 Flavomycin® / Stenorol® Bambermycins, Halofuginone Hydrobromide
139-473 Stafac® / Stenorol® Halofuginone Hydrobromide, Virginiamycin
140-340 Lincomix® / Stenorol® Halofuginone Hydrobromide, Lincomycin
Hydrochloride
140-533 3-Nitro® / BMD® / Stenorol® Bacitracin Methylene Disalicylate, Halofuginone
Hydrobromide, Roxarsone
140-584 BMD / Stenorol® Bacitracin Methylene Disalicylate, Halofuginone
Hydrobromide
140-824 Stenorol® Type A Medicated Article Halofuginone Hydrobromide
140-918 Flavomycin® / Stenorol® Bambermycins, Halofuginone Hydrobromide
140-919 BMD® / Stenorol® Bacitracin Methylene Disalicylate, Halofuginone
Hydrobromide
Halofuginone Hydrobromide, cont.
141-157 3-Nitro® / Stenorol® Halofuginone Hydrobromide, Roxarsone
Halothane
014-170 Fluothane Halothane
Halothane, USP
200-200 Halothane, USP Halothane
Haloxon
048-913 Halox Wormer Drench Haloxon
092-483 Halox Bolus Haloxon

January 15, 2008 FDA APPROVED ANIMAL DRUG PRODUCTS 2.25


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Hemoglobin Glutamer-200 (bovine)
141-067 Oxyglobin® Hemoglobin Glutamer-200 (bovine)
Hetacillin Potassium
055-021 Hetacin® K Capsules Vet Hetacillin Potassium
055-022 Hetacin® K Tablets Hetacillin Potassium
055-048 Hetacin® K Oral Liquid Hetacillin Potassium
055-054 Hetacin® K Hetacillin Potassium
Hetacin® K Intramammary Infusion
Hexamethyltetracosane
032-322 Liquisone F with Cerumene H
examethyltetracosane, Neomycin Sulfate,
Prednisolone, Tetracaine
Hyaluronate Sodium
112-048 Hylartin® V Hyaluronate Sodium
122-578 Hyvisc Sterile Injection Hyaluronate Sodium
139-913 Equron® Hyaluronate Sodium
140-474 Synacid™ Hyaluronate Sodium
140-806 Hyalovet® Hyaluronate Sodium
140-883 Legend™ Injectable Solution Hyaluronate Sodium
Legend® Multi Dose
Hydrochlorothiazide
013-674 Hydrozide Injection Hydrochlorothiazide
Hydrocortisone
013-293 L
iqua-Cortril Spray Hydrocortisone, Oxytetracycline Hydrochloride
Terra-Cortril Spray
Hydrocortisone Acetate
010-524 Neo-Cortef® with Tetracaine Hydrocortisone Acetate, Neomycin Sulfate,
Tetracaine Hydrochloride
040-322 Kymar Ointment Improved Chymotrypsin, Hydrocortisone Acetate, Neomycin
Palmitate, Trypsin
043-784 Kanfosone Ointment Amphomycin Calcium, Hydrocortisone Acetate,
Kanamycin Sulfate
047-997 Amphoderm Ointment Amphomycin Calcium, Hydrocortisone Acetate,
Kanamycin Sulfate
065-015 Bacitracin-Neomycin-Polymyxin with Hydrocortisone Bacitracin Zinc, Hydrocortisone Acetate, Neomycin
Acetate Ophthalmic Ointment Sulfate, Polymyxin B Sulfate
Vetropolycin HC Ophthalmic Ointment
065-119 Forte Topical® Ointment Hydrocortisone Acetate, Neomycin Sulfate, Penicillin
G Procaine, Polymyxin B Sulfate
065-476 Cortisporin Veterinary Ophthalmic Ointment Bacitracin Zinc, Hydrocortisone Acetate, Neomycin
Sulfate, Polymyxin B Sulfate
093-514 Neo-Cortef® Sterile Ointment Hydrocortisone Acetate, Neomycin Sulfate
Hydrogen Peroxide
141-255 35% Perox-aid® Hydrogen Peroxide
Hygromycin B
010-918 Hygromix 2.4 Hygromycin B
011-948 Hygromix 2.4 Hygromycin B
012-548 Tylosin® / Hygromix Hygromycin B, Tylosin Phosphate
013-214 Purina® Hygromix-Swine Hygromycin B
013-388 Hygromix-Tylan® Premix Hygromycin B, Tylosin
109-688 Hygromix 2.4 Premix Hygromycin B
I.N. Hygromycin-2.4 Premix

2.26 FDA APPROVED ANIMAL DRUG PRODUCTS January 15, 2008


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Hygromycin B, cont.
110-439 HFA Hygromix 0.48 Medicated Premix Hygromycin B
HFA Hygromix 2.4 Medicated Premix
127-508 Hygromix 0.6 Hygromycin B
140-443 Hygromix 0.6 Premix Hygromycin B
Hygromix 1.6 Premix
140-842 Hygromix 2.4 Premix (Type A Medicated Article) Hygromycin B
Imidacloprid
141-208 Advantage® DUO Imidacloprid, Ivermectin
141-251 Advantage Multi™ Imidacloprid, Moxidectin
141-254 Advantage Multi™ Imidacloprid, Moxidectin
Imidocarb Dipropionate
097-288 Imizol® Equine Injection Imidocarb Dipropionate
141-071 Imizol® Imidocarb Dipropionate
Iodinated Casein
005-633 Protomone Thyroactive Casein Iodinated Casein
013-502 Protamone-D Iodinated Casein
Iodochlorhydroxyquin
031-448 Rheaform Bolus Iodochlorhydroxyquin
Iron Dextran Complex
010-793 Nonemic Iron Dextran Complex
010-865 Ferrextran 100 Iron Dextran Complex
011-879 Rubrafer Iron Dextran Complex
Rubrafer S-100
099-667 Imposil Iron Dextran Complex
106-772 Iron Dextran Complex Iron Dextran Complex
113-748 Purina® Oral Pigemia Iron Dextran Complex
119-142 PVL Iron Dextran Injectable Iron Dextran Complex
134-708 Iron Dextran Complex Inj. Iron Dextran Complex
138-255 Iron Hydrogenated Dextran Injection Iron Dextran Complex
200-254 Iron Dextran Injection Iron Dextran Complex
Iron Dextran Injection 100mg
200-256 Iron Dextran Injection - 200 Iron Dextran Complex
Isoflupredone Acetate
011-789 Predef® 2x Sterile Aqueous Suspension Isoflupredone Acetate
015-433 Neo-Predef® with Tetracaine Ointment Isoflupredone Acetate, Myristyl-gamma-picolinium
Chloride, Neomycin Sulfate, Tetracaine
Hydrochloride
030-025 Neo-Predef® with Tetracaine Top. Ointment Isoflupredone Acetate, Neomycin Sulfate, Tetracaine
Tritop® Topical Ointment Hydrochloride
034-872 Neo Predef® Sterile Ointment Isoflupredone Acetate, Neomycin Sulfate
Isoflurane
135-773 Aerrane® Isoflurane
200-070 IsoFlo™ Isoflurane
200-129 Isoflurane, USP Isoflurane
200-141 Isoflurane, USP Isoflurane
200-187 Isoflurane, USP Isoflurane
200-237 Isoflurane, USP Isoflurane

January 15, 2008 FDA APPROVED ANIMAL DRUG PRODUCTS 2.27


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Isopropamide Iodide
013-201 Darbazine Spansule No.1 Isopropamide Iodide, Prochlorperazine Maleate
Darbazine Spansule No.3
015-147 Darbazine Injectable Isopropamide Iodide, Prochlorperazine Edisylate
031-914 Neo-Darbazine Spansule Capsule No.1 Isopropamide Iodide, Neomycin Sulfate,
Neo-Darbazine Spansule Capsule No.3 Prochlorperazine Dimaleate
Ivermectin
127-443 Eqvalan® Injection Ivermectin
128-409 Ivomec® 0.27% Injection Grower And Feeder Pigs Ivermectin
Ivomec® 1% Injection
Ivomec® 1% Injection for Cattle And Swine
Ivomec® Injection for Cattle
131-392 Ivomec® Liquid Ivermectin
134-314 EQUIMECTRIN® Paste 1.87% Ivermectin
Eqvalan®

Eqvalan® Paste For Horses

ZIMECTERIN® Paste 1.87%

137-006 Ivomec® Cattle Paste 0.153% Ivermectin


138-412 Heartgard 30® Ivermectin
Heartgard® Tablets
140-439 Eqvalan® Oral Liquid Ivermectin
Eqvalan® Oral Liquid For Horses
140-833 Ivomec® F Injection For Cattle Clorsulon, Ivermectin
Ivomec® Plus Injection For Cattle
140-841 Ivomec® Pour-On For Cattle Ivermectin
140-886 Heartgard 30® Chewables Ivermectin
Heartgard® Chewables For Dogs
140-971 Heartgard® Plus Ivermectin, Pyrantel Pamoate
Heartgard® Plus For Dogs
140-974 Ivomec® Premix for Swine Ivermectin
140-988 Ivomec® Sustained-Release Bolus for Cattle Ivermectin
141-054 Ivomec® Premix for Swine / Lincomix® Premix Ivermectin, Lincomycin
141-078 Heartgard® for Cats Ivermectin
141-097 BMD® / Ivomec® Premix for Swine Bacitracin Methylene Disalicylate, Ivermectin
141-174 Acarexx® Ivermectin
141-208 Advantage® DUO Imidacloprid, Ivermectin
141-214 Zimecterin® Gold Paste Ivermectin, Praziquantel
141-215 Equimax™ Paste Ivermectin, Praziquantel
141-241 Zimecterin-EZ™ Ivermectin
141-257 Iverhart Max™ Ivermectin, Praziquantel, Pyrantel Pamoate
200-202 Ivercide™ Liquid for Horses Ivermectin
Ivermectin Liquid for Horses

Phoenectin™ Liquid for Horses

200-219 Ivermectin Pour-On for Cattle Ivermectin


Phoenectin™ Pour-On for Cattle
Phoenectin®
200-228 Phoenectin™ Injection for Cattle and Swine Ivermectin
200-270 Iverhart™ Tablets Ivermectin
200-272 Noromectin® Pour-On for Cattle Ivermectin
200-286 Phoenectin™ Paste 1.87% Ivermectin
200-292 Iversol Liquid for Horses Ivermectin
200-297 Ivermectin Chewable Tablets Ivermectin
200-299 Iver-On™ Ivermectin

2.28 FDA APPROVED ANIMAL DRUG PRODUCTS January 15, 2008


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Ivermectin, cont.
200-302 Iverhart™ Plus Flavored Chewables Flavored Tablets Ivermectin, Pyrantel Pamoate
200-318 Virbamec™ Pour-On Ivermectin
200-320 Equell™ Ivermectin
200-321 Primectin™ Equine Oral Liquid Ivermectin
200-326 Bimectin™ Ivermectin
200-327 Primectin™ Drench for Sheep Ivermectin
200-338 Tri-Heart Plus Chewable Tablets Ivermectin, Pyrantel Pamoate
200-340 Privermectin™ Ivermectin
200-341 SparMectin-E Ivermectin
200-348 Ecomectin Ivermectin
200-390 Ivermectin Paste 1.87 % Ivermectin
200-436 Noromectin® Plus Clorsulon, Ivermectin
200-437 Noromectin® Ivermectin
Kanamycin Sulfate
041-836 Kantrim® 200 Kanamycin Sulfate
042-548 Amforol® Suspension Attapulgite, Bismuth Subcarbonate, Kanamycin
Sulfate
042-661 Kantrim® Ophthalmic Ointment Kanamycin Sulfate
042-841 Amforol® Veterinary Oral Tablets Attapulgite, Bismuth Subcarbonate, Kanamycin
Sulfate
042-883 Kantrim® Ophthalmic Solution Kanamycin Sulfate
043-784 Kanfosone Ointment Amphomycin Calcium, Hydrocortisone Acetate,
Kanamycin Sulfate
047-997 Amphoderm Ointment Amphomycin Calcium, Hydrocortisone Acetate,
Kanamycin Sulfate
Ketamine Hydrochloride
043-304 Ketaset® Ketamine Hydrochloride
045-290 Ketaset® Ketamine Hydrochloride
Vetalar
092-116 Ketaset® Plus Aminopentamide Hydrogen Sulfate, Ketamine
Hydrochloride, Promazine Hydrochloride
200-029 Ketamine Hydrochloride Injection Ketamine Hydrochloride
200-042 Ketaject® Ketamine Hydrochloride
Ketamine Hydrochloride Injection, USP
200-055 VetaKet® Ketamine Hydrochloride
200-073 Ketamine Hydrochloride Injection, USP Ketamine Hydrochloride
200-257 Ketamine HCl Ketamine Hydrochloride
200-279 KetaFlo™ Ketamine Hydrochloride
Ketoprofen
140-269 K
etofen™ Ketoprofen
Laidlomycin Propionate Potassium
141-025 Cattlyst® Laidlomycin Propionate Potassium
141-201 Aureomycin® / Cattlyst® Chlortetracycline, Laidlomycin Propionate Potassium
Lasalocid
096-298 A
vatec® Lasalocid
Bovatec® 68 Type A Medicated Article
Bovatec® Liquid 20 (liquid Type A Article)
Bovatec® Premix
Bovatec® Type A Medicated Article
101-689 Avatec® / Lincomix® Lasalocid, Lincomycin Hydrochloride

January 15, 2008 FDA APPROVED ANIMAL DRUG PRODUCTS 2.29


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Lasalocid, cont.
102-485 3-Nitro® / Avatec® Lasalocid, Roxarsone
107-996 Avatec® / Fortracin Premix Bacitracin Methylene Disalicylate, Lasalocid
112-661 3-Nitro® / Avatec® / Lincomycin Lasalocid, Lincomycin Hydrochloride, Roxarsone
112-687 3-Nitro® / Avatec® / Flavomycin® Bambermycins, Lasalocid, Roxarsone
116-082 3-Nitro® / Avatec® / BMD® Bacitracin Methylene Disalicylate, Lasalocid,
Roxarsone
122-608 Avatec® / Stafac® Lasalocid, Virginiamycin
126-052 3-Nitro® / Avatec® / Baciferm® Bacitracin Zinc, Lasalocid, Roxarsone
131-894 3-Nitro® / Avatec® / Fortracin Broiler Premix Bacitracin Methylene Disalicylate, Lasalocid,
Roxarsone
138-904 Bovatec® / MGA® 100 / Tylan® Lasalocid, Melengestrol Acetate, Tylosin Phosphate
Bovatec® / MGA® 100-200 Premix / Tylan®
Bovatec® / MGA® 200 / Tylan®
Bovatec® / MGA® 500 Liquid Premix / Tylan®
138-992 Bovatec® / MGA® (liquid) / Tylan® Lasalocid, Melengestrol Acetate, Tylosin Phosphate
138-993 Moorman's® Cattle Minerals BT Lasalocid
139-876 Bovatec® / MGA® 100 Lasalocid, Melengestrol Acetate
Bovatec® / MGA® 200
140-288 Bovatec® / MGA® 500 Lasalocid, Melengestrol Acetate
140-579 Bovatec® / Terramycin® Lasalocid, Oxytetracycline (Monoalkyl Trimethyl
Ammonium Salt)
141-083 Avatec® / Baciferm® Bacitracin Zinc, Lasalocid
141-109 Avatec® / Baciferm® Bacitracin Zinc, Lasalocid
141-129 Avatec® / Flavomycin® Bambermycins, Lasalocid
141-150 Avatec® / Stafac® Lasalocid, Virginiamycin
141-171 Purina Sugar Mag Block 1440 BVT Medicated Mineral Lasalocid
Block
141-179 Avatec® / BMD® Bacitracin Methylene Disalicylate, Lasalocid
141-181 Avatec® / Albac® Bacitracin Zinc, Lasalocid
141-187 Crystalyx® Iono-Lyx® Lasalocid
141-250 Aureomycin® / Bovatec® Chlortetracycline, Lasalocid
200-208 Avatec® / 3-Nitro® / Albac® Bacitracin Zinc, Lasalocid, Roxarsone
200-430 HeifermaX™ 500 Liquid Premix / Bovatec® / Tylan® Lasalocid, Melengestrol Acetate, Tylosin Phosphate
200-451 HeifermaX® 500 / Bovatec® Lasalocid, Melengestrol Acetate
Levamisole
139-877 Totalon™ Topical Cattle Anthelmintic Levamisole
140-844 Tramisol® Pour-On Levamisole
Levamisole Hydrochloride
039-356 Ripercol L Bolus Levamisole Hydrochloride
Tramisol® Cattle Wormer Bolus
039-357 Ripercol L Soluble Drench Powder Levamisole Hydrochloride
042-740 Ripercol L Levamisole Hydrochloride
Tramisol® Soluble Drench Powder for Sheep
042-837 Ripercol L Wormer Oblets Levamisole Hydrochloride
Tramisol® Sheep Wormer Oblets
044-015 Tramisol® Type A Medicated Article Levamisole Hydrochloride
045-455 Tramisol® Type A Medicated Article Levamisole Hydrochloride
045-513 Ripercol L Levamisole Hydrochloride
091-826 Levasole® Cattle Wormer Bolus Levamisole Hydrochloride
Tramisol® Cattle Wormer Oblets Tablets

2.30 FDA APPROVED ANIMAL DRUG PRODUCTS January 15, 2008


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Levamisole Hydrochloride, cont.
092-237 Ripercol L-Piperazine Soluble Levamisole Hydrochloride, Piperazine
Dihydrochloride
093-688 Ripercol L-Piperazine Levamisole Hydrochloride, Piperazine
Dihydrochloride
107-085 Tramisol® Levamisole Hydrochloride
112-049 Levasole® Soluble Pig Wormer Levamisole Hydrochloride
112-051 Levamisole Soluble Drench Powder Levamisole Hydrochloride
Levasole®
Levasole® Soluble Drench Powder
Tramisol® Soluble Drench Powder
112-052 Levasole® Sheep Wormer Bolus Levamisole Hydrochloride
Tramisole Sheep Wormer Oblets Tablets
126-237 Tramisol® Gel Levamisole Hydrochloride
200-225 Prohibit™ Soluble Drench Powder Levamisole Hydrochloride
200-313 Levamisole Hydrochloride Soluble Pig Wormer Levamisole Hydrochloride
200-386 Levamisole Hydrochloride Soluble Drench Powder Levamisole Hydrochloride
Levamisole Phosphate
049-553 Ripercol L Levamisole Phosphate
102-437 Tramisol® Injectable Solution Levamisole Phosphate
126-742 Levasole® Injectable Solution Levamisole Phosphate
200-271 Levamisole Phosphate Levamisole Phosphate
Levamisole Resinate
101-079 Tramisol® 10% Pig Wormer Levamisole Resinate
Tramisol® Hog Wormer
139-858 Tramisol®-X-Tra Cattle Anthelmintic and Extoparasitic Famphur, Levamisole Resinate
Paste
Lidocaine
013-146 Liquamycin® Intramuscular Lidocaine, Oxytetracycline Hydrochloride
049-948 Aquachel 100 mg Lidocaine, Oxytetracycline Hydrochloride
141-245 Tributame™ Euthanasia Solution Chloroquine Phosphate, Embutramid, Lidocaine
Lincomycin
047-262 Deccox® / Lincomycin Decoquinate, Lincomycin
Decoquinate & Lincomycin
137-537 Bio-Cox® / Lincomix® Lincomycin, Salinomycin Sodium
140-947 Lincomix® / Maxiban® Lincomycin, Narasin, Nicarbazin
140-954 Lincomix® Type A Medicated Article Fenbendazole, Lincomycin
Safe-Guard® Type A Medicated Article
141-054 Ivomec® Premix for Swine / Lincomix® Premix Ivermectin, Lincomycin
200-090 3-Nitro® / Lincomix® / Sacox® Lincomycin, Roxarsone, Salinomycin Sodium
200-093 Sacox® / Lincomix® Lincomycin, Salinomycin Sodium
200-170 3-Nitro® / Lincomix® / Nicarmix 25® Lincomycin, Nicarbazin, Roxarsone
200-171 Lincomix® / Nicarmix 25® Lincomycin, Nicarbazin
200-274 Lincomycin Injectable 30% Lincomycin
200-315 L incomycin 25 Lincomycin
Lincomycin 100
Lincomycin 300
Lincomycin Injection 25
Lincomycin Injection 100
Lincomycin Injection 300
200-351 Lincomycin Injectable, USP Lincomycin

January 15, 2008 FDA APPROVED ANIMAL DRUG PRODUCTS 2.31


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Lincomycin Hydrochloride
092-482 Coban® / Lincomix® Lincomycin Hydrochloride, Monensin Sodium
092-522 Coban® / Lincomix® Lincomycin Hydrochloride, Monensin
Coban® / Lincomix® / Roxarsone
093-106 Lincomix® / Robenz® Lincomycin Hydrochloride, Robenidine
Hydrochloride
101-689 Avatec® / Lincomix® Lasalocid, Lincomycin Hydrochloride
107-997 Medicated Broiler Feed Lincomycin Hydrochloride, Nicarbazin, Roxarsone
108-116 Nicarbazin Lincomycin Premix Lincomycin Hydrochloride, Nicarbazin
111-636 Lincomix® Soluble Powder Lincomycin Hydrochloride
112-661 3-Nitro® / Avatec® / Lincomycin Lasalocid, Lincomycin Hydrochloride, Roxarsone
132-923 Linco 8 Lincomycin Hydrochloride
Linco 20
140-340 Lincomix® / Stenorol® Halofuginone Hydrobromide, Lincomycin
Hydrochloride
140-581 3-Nitro® / Bio-Cox® / Lincomix® Lincomycin Hydrochloride, Roxarsone, Salinomycin
Sodium
200-189 Lincomycin Soluble Lincomycin Hydrochloride
200-233 Linco Soluble Lincomycin Hydrochloride
200-241 Lincosol Soluble Powder Lincomycin Hydrochloride
200-303 Lincomycin Hydrochloride Soluble Powder Lincomycin Hydrochloride
200-368 LincoMed™ 100 Lincomycin Hydrochloride
LincoMed™ 300
200-377 Lincomed Soluble Powder Lincomycin Hydrochloride
200-407 Lincomycin-Spectinomycin Water Soluble Powder Lincomycin Hydrochloride, Spectinomycin
Dihydrochloride Pentahydrate
Lincomycin Hydrochloride Monohydrate
033-887 Lincocin® Tablets Lincomycin Hydrochloride Monohydrate
034-025 Lincocin® Sterile Solution (Rx) Lincomycin Hydrochloride Monohydrate
Lincomix® Injectable - 25
Lincomix® Injectable - 50
Lincomix® Injectable - 100
Lincomix® Injectable - 300
034-085 Lincomix® Feed Medication Lincomycin Hydrochloride Monohydrate
040-587 Lincocin® Aquadrops Lincomycin Hydrochloride Monohydrate
041-178 Amprol® Plus / Lincomix® / Roxarsone Amprolium, Ethopabate, Lincomycin Hydrochloride
Monohydrate, Roxarsone
044-820 Lincomix® / Amprol Plus Amprolium, Ethopabate, Lincomycin Hydrochloride
Monohydrate
044-972 Coyden® / Lincomix® Clopidol, Lincomycin Hydrochloride Monohydrate
045-738 Lincomix® / Bonaid Buquinolate, Lincomycin Hydrochloride
Lincomycin / Buquinolate Monohydrate
046-109 L-S 50 Water Soluble® Powder Lincomycin Hydrochloride Monohydrate,
Spectinomycin Sulfate Tetrahydrate
047-261 Lincomix® / Deccox® Decoquinate, Lincomycin Hydrochloride
Monohydrate
048-954 Lincomix® / Zoamix® Lincomycin Hydrochloride Monohydrate, Zoalene
097-505 Lincomix® 10 Feed Medications Lincomycin Hydrochloride Monohydrate
Lincomix® 20 Feed Medications
Lincomix® 50 Feed Medications
116-044 Banminth® / Lincomix® Lincomycin Hydrochloride Monohydrate, Pyrantel
Tartrate
132-574 Purina® Check-R-Ton LI. Lincomycin Hydrochloride Monohydrate

2.32 FDA APPROVED ANIMAL DRUG PRODUCTS January 15, 2008


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Lincomycin Hydrochloride Monohydrate, cont.
138-941 Banminth® / Lincomix® Lincomycin Hydrochloride Monohydrate, Pyrantel
Banminth® / Lincomix® 20 Tartrate
200-345 Lincomycin - Spectinomycin Lincomycin Hydrochloride Monohydrate,
Spectinomycin Dihydrochloride Pentahydrate
200-380 SpecLinx-50™ Lincomycin Hydrochloride Monohydrate,
Spectinomycin Dihydrochloride Pentahydrate
Liothyronine Sodium
014-366 Cytobin Tablets Liothyronine Sodium
Lufenuron
141-026 Program® Suspension Lufenuron
141-035 Program® Lufenuron
Program® Flavor Tabs®
141-062 Program® Cat Flavor Tabs™ Lufenuron
141-084 Sentinel® Flavor Tabs™ Lufenuron, Milbemycin Oxime
141-105 Program® 6 Month Injectable for Cats Lufenuron
141-204 Sentinel® Flavor Tabs® and Capstar® Flea Management Lufenuron, Milbemycin Oxime, Nitenpyram
System™
141-205 Program® Flavor Tabs® and Capstar® Flea Management Lufenuron, Nitenpyram
System™
Luprostiol
140-857 Equestrolin™ Luprostiol
Prosolvin®
Maduramicin Ammonium
139-075 Cygro® Maduramicin Ammonium
Magnesium Sulfate
046-789 C
hloropent Chloral Hydrate, Magnesium Sulfate, Pentobarbital
Marbofloxacin
141-151 Zeniquin® Marbofloxacin
Zeniquin® Tablets
Maropitant
141-262 Cerenia™ Maropitant
141-263 Cerenia™ Maropitant
Mebendazole
091-736 Telmin® Equine Wormer Mebendazole
097-221 Telmin® Syringe Formula Mebendazole
100-402 Telmin® B Equine Wormer Mebendazole, Trichlorfon
102-987 Telmintic Powder Mebendazole
118-394 Telmin® Mebendazole
138-954 Telmin® B Paste Mebendazole, Trichlorfon
Meclofenamic Acid
095-641 Arquel Granules Meclofenamic Acid
110-201 Arquel Tablets Meclofenamic Acid
Medetomidine
140-999 Domitor® Medetomidine
Megestrol Acetate
091-603 Ovaban® Tablets 5 mg Megestrol Acetate
Ovaban® Tablets 20 mg
Melarsomine Dihydrochloride
141-042 Immiticide Sterile Powder Melarsomine Dihydrochloride

January 15, 2008 FDA APPROVED ANIMAL DRUG PRODUCTS 2.33


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Melatonin
140-846 PrimeX® Melatonin
Melengestrol Acetate
034-254 MGA® 100 Premix Melengestrol Acetate
MGA® 200 Premix
MGA® 500 Liquid Premix
039-402 MGA® 500 Liquid Premix Melengestrol Acetate
046-718 MGA® (liquid) / Terramycin® Melengestrol Acetate, Oxytetracycline
046-719 MGA® (dry) / Terramycin® Melengestrol Acetate, Oxytetracycline
124-309 MGA® 100-200 / Rumensin® Melengestrol Acetate, Monensin Sodium
MGA® 100-200 Premix / Rumensin®
125-476 MGA® 500 / Rumensin® Melengestrol Acetate, Monensin Sodium
MGA® 500 Liquid Premix / Rumensin®
138-792 MGA® 100 / Rumensin® / Tylan® Melengestrol Acetate, Monensin Sodium, Tylosin
MGA® 200 / Rumensin® / Tylan® Phosphate
138-870 MGA® (liquid) / Rumensin® / Tylan® Melengestrol Acetate, Monensin Sodium, Tylosin
MGA® 100-200 Premix / MGA® 500 Liquid Premix / Phosphate
Rumensin® / Tylan®
138-904 Bovatec® / MGA® 100 / Tylan® Lasalocid, Melengestrol Acetate, Tylosin Phosphate
Bovatec® / MGA® 100-200 Premix / Tylan®
Bovatec® / MGA® 200 / Tylan®
Bovatec® / MGA® 500 Liquid Premix / Tylan®
138-992 Bovatec® / MGA® (liquid) / Tylan® Lasalocid, Melengestrol Acetate, Tylosin Phosphate
138-995 MGA® 100 / Tylan® Melengestrol Acetate, Tylosin Phosphate
MGA® 200 / Tylan®
139-192 MGA® 500 (liquid)-Tylan® Melengestrol Acetate, Tylosin Phosphate
139-876 Bovatec® / MGA® 100 Lasalocid, Melengestrol Acetate
Bovatec® / MGA® 200
140-288 Bovatec® / MGA® 500 Lasalocid, Melengestrol Acetate
141-233 Optaflexx™ / Rumensin® / Tylan® / MGA® Melengestrol Acetate, Monensin Sodium,
Ractopamine Hydrochloride, Tylosin Phosphate
141-234 Optaflexx™ / Rumensin® / MGA® Melengestrol Acetate, Monensin Sodium,
Ractopamine Hydrochloride
200-343 HeifermaX™ 500 Melengestrol Acetate
200-375 HeifermaX™ 500 / Rumensin® / Tylan® Melengestrol Acetate, Monensin Sodium, Tylosin
Phosphate
200-422 HeifermaX 500 Liquid Premix / Rumensin® Melengestrol Acetate, Monensin Sodium
200-424 HeifermaX™ / Optaflexx® / Rumensin® / Tylan® Melengestrol Acetate, Monensin Sodium,
Ractopamine Hydrochloride, Tylosin Phosphate
200-427 HeifermaX™ 500 Liquid Premix / Tylan® Melengestrol Acetate, Tylosin Phosphate
200-430 HeifermaX™ 500 Liquid Premix / Bovatec® / Tylan® Lasalocid, Melengestrol Acetate, Tylosin Phosphate
200-448 HeifermaX® / Optaflexx® / Rumensin® Melengestrol Acetate, Monensin Sodium,
Ractopamine Hydrochloride
200-451 HeifermaX® 500 / Bovatec® Lasalocid, Melengestrol Acetate
Meloxicam
141-213 Metacam® Oral Suspension Meloxicam
141-219 Metacam® Meloxicam
Metacam® 5 mg/mL Solution for Injection
Mepivacaine Hydrochloride
100-703 Carbocaine®-V Sterile Aqueous Solution Mepivacaine Hydrochloride
Methenamine Mandelate
030-416 Mesulfin Tablets Methenamine Mandelate, Sulfamethizole

2.34 FDA APPROVED ANIMAL DRUG PRODUCTS January 15, 2008


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Methocarbamol
038-838 Robaxin®-V Injectable Methocarbamol
045-715 Robaxin®-V Tablets Methocarbamol
Methoxyflurane
014-485 M
etofane® Inhalation Methoxyflurane
Methylprednisolone
011-403 Medrol® Tablets Methylprednisolone
011-700 Cortaba® Tablets Acetylsalicylic Acid, Methylprednisolone
135-771 Methylprednisolene Tablets Methylprednisolone
Methylprednisolone Acetate
012-204 Depo-Medrol® (20 mg) Sterile Aqueous Suspension Methylprednisolone Acetate
136-212 Methylprednisolone Acetate Inj. Methylprednisolone Acetate
Metoserpate Hydrochloride
032-738 P
acitran Metoserpate Hydrochloride
Mibolerone
102-709 Cheque® Drops Mibolerone
107-347 Cheque® Medicated Dog Food Mibolerone
Miconazole Nitrate
095-183 Conofite® Cream 2% Miconazole Nitrate
095-184 Conofite® Lotion 1% Miconazole Nitrate
Conofite® Spray 1%
200-196 Miconosol Miconazole Nitrate
200-362 Priconazole™ Lotion 1% and Spray 1% Miconazole Nitrate
Milbemycin Oxime
140-915 I nterceptor® Milbemycin Oxime
Interceptor® Flavor Tabs®
Interceptor® Flavor Tabs® for Cats
SafeHeart™
141-084 Sentinel® Flavor Tabs™ Lufenuron, Milbemycin Oxime
141-163 Milbemite™ Otic Solution Milbemycin Oxime
141-204 Sentinel® Flavor Tabs® and Capstar® Flea Management Lufenuron, Milbemycin Oxime, Nitenpyram
System™
Mometasone Furoate Monohydrate
141-177 Mometamax™ Otic Suspension Clotrimazole, Gentamicin Sulfate, Mometasone
Furoate Monohydrate
Monensin
049-464 Monensin / Bacitracin / Roxarsone Bacitracin Methylene Disalicylate, Monensin,
Roxarsone
092-522 Coban® / Lincomix® Lincomycin Hydrochloride, Monensin
Coban® / Lincomix® / Roxarsone
098-341 3-Nitro® / Coban® / Flavomycin® Bambermycins, Monensin, Roxarsone
140-955 Coban® / Flavomycin® Monensin, Tylosin Phosphate
141-110 Coban® / Stafac® Monensin, Virginiamycin
141-138 3-Nitro® / BMD® / Coban® Bacitracin Methylene Disalicylate, Monensin,
Roxarsone
141-139 3-Nitro® / Coban® Monensin, Roxarsone
141-140 BMD® / Coban® Bacitracin Methylene Disalicylate, Monensin
141-149 Deccox® / Rumensin® / Tylan® Decoquinate, Monensin, Tylosin
141-164 Coban® / Tylan® Monensin, Tylosin Phosphate
200-211 3-Nitro® / Albac® / Coban® Bacitracin Zinc, Monensin, Roxarsone

January 15, 2008 FDA APPROVED ANIMAL DRUG PRODUCTS 2.35


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Monensin Sodium
038-878 Coban® - 45 Monensin Sodium
Coban® - 60
Coban® - 110
Elancoban-100
041-500 Coban® - 1 Monensin Sodium, Roxarsone
047-933 Monensin / Zinc Bacitracin Premix Bacitracin Zinc, Monensin Sodium
049-463 Monensin / Bacitracin MD Bacitracin Methylene Disalicylate, Monensin Sodium
092-482 Coban® / Lincomix® Lincomycin Hydrochloride, Monensin Sodium
095-735 Rumensin® Monensin Sodium
Rumensin® 80
098-340 Flavomycin® / Monensin Bambermycins, Monensin Sodium
099-006 Terramycin® TM-50 Monensin Sodium, Oxytetracycline (Monoalkyl
TM-10 Plus Trimethyl Ammonium Salt)
104-646 Rumensin® / Tylan® Monensin Sodium, Tylosin Phosphate
109-471 Cattle Block M Monensin Sodium
Staley Sweetlix with Rumensin®
115-581 Moorman's® Mintrate Blonde Block Monensin Sodium
Moorman's® Mintrate Red Block RU
116-088 3-Nitro® / BMD® / Coban® Bacitracin Methylene Disalicylate, Monensin
3-Nitro® / Coban® / Fortracin Sodium, Roxarsone
118-509 Pasture Gainer Block-37 R350 Monensin Sodium
119-253 Cattle Block M Monensin Sodium
120-724 3-Nitro® / Stafac® / Coban® Monensin Sodium, Roxarsone, Virginiamycin
121-553 Aureomycin® / Coban® Chlortetracycline Hydrochloride, Monensin Sodium
122-481 Coban® / Stafac® Monensin Sodium, Virginiamycin
123-154 3-Nitro®-10 / Baciferm® / Coban® Premix Bacitracin Zinc, Monensin Sodium, Roxarsone
124-309 MGA® 100-200 / Rumensin® Melengestrol Acetate, Monensin Sodium
MGA® 100-200 Premix / Rumensin®
125-476 MGA® 500 / Rumensin® Melengestrol Acetate, Monensin Sodium
MGA® 500 Liquid Premix / Rumensin®
130-736 Coban® Monensin Sodium
134-830 Albac® / Coban® Bacitracin Zinc, Monensin Sodium
138-456 Coban® / BMD® Bacitracin Methylene Disalicylate, Monensin Sodium
138-703 3-Nitro® / Albac® / Coban® Bacitracin Zinc, Monensin Sodium, Roxarsone
138-792 MGA® 100 / Rumensin® / Tylan® Melengestrol Acetate, Monensin Sodium, Tylosin
MGA® 200 / Rumensin® / Tylan® Phosphate
138-870 MGA® (liquid) / Rumensin® / Tylan® Melengestrol Acetate, Monensin Sodium, Tylosin
MGA® 100-200 Premix / MGA® 500 Liquid Premix / Phosphate
Rumensin® / Tylan®
140-937 BMD® / Coban® Bacitracin Methylene Disalicylate, Monensin Sodium
141-148 Deccox® / Rumensin® Decoquinate, Monensin Sodium
141-224 Optaflexx™ / Rumensin® / Tylan® Monensin Sodium, Ractopamine Hydrochloride,
Tylosin Phosphate
141-225 Optaflexx™ / Rumensin® Monensin Sodium, Ractopamine Hydrochloride
141-233 Optaflexx™ / Rumensin® / Tylan® / MGA® Melengestrol Acetate, Monensin Sodium,
Ractopamine Hydrochloride, Tylosin Phosphate
141-234 Optaflexx™ / Rumensin® / MGA® Melengestrol Acetate, Monensin Sodium,
Ractopamine Hydrochloride
200-263 ChlorMax™ / Coban® Chlortetracycline, Monensin Sodium
200-354 Pennchlor™ / Coban® Chlortetracycline Hydrochloride, Monensin Sodium
200-375 HeifermaX™ 500 / Rumensin® / Tylan® Melengestrol Acetate, Monensin Sodium, Tylosin
Phosphate

2.36 FDA APPROVED ANIMAL DRUG PRODUCTS January 15, 2008


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Monensin Sodium, cont.
200-422 HeifermaX 500 Liquid Premix / Rumensin® Melengestrol Acetate, Monensin Sodium
200-424 HeifermaX™ / Optaflexx® / Rumensin® / Tylan® Melengestrol Acetate, Monensin Sodium,
Ractopamine Hydrochloride, Tylosin Phosphate
200-448 HeifermaX® / Optaflexx® / Rumensin® Melengestrol Acetate, Monensin Sodium,
Ractopamine Hydrochloride
Morantel Tartrate
092-444 Rumatel® Medicated Premix-88 Morantel Tartrate
093-903 Rumatel® Cattle Wormer Bolus Morantel Tartrate
134-779 Paratect Flex™ Morantel Tartrate
Moxidectin
141-051 ProHeart™ Moxidectin
141-087 Quest® 2% Equine Oral Gel Moxidectin
Quest® Gel
141-099 Cydectin® (moxidectin) 0.5% Pour-On for Beef and Dairy Moxidectin
Cattle
Cydectin® Pour-On for Cattle
141-189 ProHeart® 6 Sustained Release Injectable for Dogs Moxidectin
141-216 Quest® Plus Gel Moxidectin, Praziquantel
141-220 Cydectin® Injectable Solution for Beef and Nonlactating Moxidectin
Dairy Cattle
141-247 Cydectin® Oral Drench for Sheep Moxidectin
141-251 Advantage Multi™ Imidacloprid, Moxidectin
141-254 Advantage Multi™ Imidacloprid, Moxidectin
Mupirocin
140-839 Bactoderm® Ointment Mupirocin
200-418 Muricin™ Mupirocin
Myristyl-gamma-picolinium Chloride
015-433 Neo-Predef® with Tetracaine Ointment Isoflupredone Acetate, Myristyl-gamma-picolinium
Chloride, Neomycin Sulfate, Tetracaine
Hydrochloride
N-butyl Chloride
046-746 Happy Jack Worm Capsules N-butyl Chloride
046-922 Sergeants® Sure Shot® Capsules N-butyl Chloride
046-923 Sergeants® Puppy Worm Capsules N-butyl Chloride
094-223 Canine Worm Caps. N-butyl Chloride
096-509 NBC Kaps Wormer N-butyl Chloride
N-Butylscopolammonium bromide
141-228 Buscopan™ Injectable Solution N-Butylscopolammonium bromide
Nalorphine Hydrochloride
010-424 Nalline Hydrochloride Nalorphine Hydrochloride
Naloxone Hydrochloride
035-825 Narcan Injection Naloxone Hydrochloride
Naltrexone Hydrochloride
141-074 Trexonil® Naltrexone Hydrochloride
Naproxen
096-674 Equiproxen Granules Naproxen
096-675 Equiproxen 10% Solution Naproxen

January 15, 2008 FDA APPROVED ANIMAL DRUG PRODUCTS 2.37


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Narasin
118-980 Monteban® Narasin
138-952 Maxiban® Narasin, Nicarbazin
140-445 Monteban® / Roxarsone Narasin, Roxarsone
140-843 3-Nitro® / Flavomycin® / Monteban® Bambermycins, Narasin, Roxarsone
140-845 Flavomycin® / Monteban® Bambermycins, Narasin
140-852 3-Nitro® / BMD® / Monteban® Bacitracin Methylene Disalicylate, Narasin,
Roxarsone
140-853 BMD® / Monteban® Bacitracin Methylene Disalicylate, Narasin
140-865 Baciferm® / Albac® Bacitracin Zinc, Narasin
Baciferm® / Monteban®
140-926 BMD® / Maxiban® Bacitracin Methylene Disalicylate, Narasin,
Nicarbazin
140-942 Flavomycin® / Maxiban® Bambermycins, Narasin, Nicarbazin
140-947 Lincomix® / Maxiban® Lincomycin, Narasin, Nicarbazin
141-112 3-Nitro® / BMD® / Maxiban® Bacitracin Methylene Disalicylate, Narasin,
Nicarbazin, Roxarsone
141-113 3-Nitro® / Maxiban® Narasin, Nicarbazin, Roxarsone
141-124 BMD® / Maxiban® Bacitracin Methylene Disalicylate, Narasin,
Nicarbazin
141-170 Monteban® / Tylan® Narasin, Tylosin Phosphate
Neomycin Palmitate
040-322 Kymar Ointment Improved Chymotrypsin, Hydrocortisone Acetate, Neomycin
Palmitate, Trypsin
Neomycin Sulfate
010-524 Neo-Cortef® with Tetracaine Hydrocortisone Acetate, Neomycin Sulfate,
Tetracaine Hydrochloride
011-315 Neomix® 325 Soluble Powder Neomycin Sulfate
Neomix® AG 325 Soluble Powder
Neomycin 325 Soluble Powder
011-437 Hydeltrone Ointment Neomycin Sulfate, Prednisolone Sodium Phosphate
011-703 Neo-Delta-Cortef® with Tetracaine Ointment Neomycin Sulfate, Prednisolone Acetate, Tetracaine
Hydrochloride
011-953 Biosol® Sterile Solution Neomycin Sulfate
Biosol® Sterile Solution 50 mg
012-258 Panolog® Ointment Neomycin Sulfate, Nystatin, Thiostrepton,
Triamcinolone Acetonide
013-181 Jenomycin Tablets Aminopropazine Fumarate, Neomycin Sulfate
015-151 Neo-synalar Cream Fluocinolone Acetonide, Neomycin Sulfate
015-433 Neo-Predef® with Tetracaine Ointment Isoflupredone Acetate, Myristyl-gamma-picolinium
Chloride, Neomycin Sulfate, Tetracaine
Hydrochloride
030-025 Neo-Predef® with Tetracaine Top. Ointment Isoflupredone Acetate, Neomycin Sulfate, Tetracaine
Tritop® Topical Ointment Hydrochloride
031-914 Neo-Darbazine Spansule Capsule No.1 Isopropamide Iodide, Neomycin Sulfate,
Neo-Darbazine Spansule Capsule No.3 Prochlorperazine Dimaleate
032-322 Liquisone F with Cerumene Hexamethyltetracosane, Neomycin Sulfate,
Prednisolone, Tetracaine
034-872 Neo Predef® Sterile Ointment Isoflupredone Acetate, Neomycin Sulfate
038-801 Anaprime® Ophthalmic Solution Flumethasone, Neomycin Sulfate, Polymyxin B
Sulfate
042-633 Tresaderm Dermatologic Solution Dexamethasone, Neomycin Sulfate, Thiabendazole
044-655 Neomycane Ophthalmic Ointment Neomycin Sulfate

2.38 FDA APPROVED ANIMAL DRUG PRODUCTS January 15, 2008


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Neomycin Sulfate, cont.
045-288 Optisone Neomycin Sulfate, Prednisolone Acetate
049-725 Anaprime® Opthakote Ophthalmic Flumethasone, Neomycin Sulfate, Polymyxin B
Sulfate
049-726 Optiprime® Opthakote Ophthalmic Solution Neomycin Sulfate, Polymyxin B Sulfate
065-015 Bacitracin-Neomycin-Polymyxin with Hydrocortisone Bacitracin Zinc, Hydrocortisone Acetate, Neomycin
Acetate Ophthalmic Ointment Sulfate, Polymyxin B Sulfate
Vetropolycin HC Ophthalmic Ointment
065-016 Bac-Neo-Poly Ophthalmic Ointment Bacitracin Zinc, Neomycin Sulfate, Polymyxin B
Vetropolycin Ophthalmic Ointment Sulfate
065-114 Mycitracin® Sterile Ophthalmic Ointment Bacitracin Zinc, Neomycin Sulfate, Polymyxin B
Sulfate
065-119 Forte Topical® Ointment Hydrocortisone Acetate, Neomycin Sulfate, Penicillin
G Procaine, Polymyxin B Sulfate
065-476 Cortisporin Veterinary Ophthalmic Ointment Bacitracin Zinc, Hydrocortisone Acetate, Neomycin
Sulfate, Polymyxin B Sulfate
065-485 Neosporin Ophthalmic Ointment Bacitracin Zinc, Neomycin Sulfate, Polymyxin B
Sulfate
091-534 Neo-Delta Cortef® Sterile Solution Neomycin Sulfate, Prednisolone Acetate
093-514 Neo-Cortef® Sterile Ointment Hydrocortisone Acetate, Neomycin Sulfate
096-676 Panolog® Cream Neomycin Sulfate, Nystatin, Thiostrepton,
Triamcinolone Acetonide
140-810 Derma-Vet™ Ointment Neomycin Sulfate, Nystatin, Thiostrepton,
Panavet Ointment Triamcinolone Acetonide
140-847 Animax Neomycin Sulfate, Nystatin, Thiostrepton,
Triamcinolone Acetonide
140-879 Derma 4 Ointment Neomycin Sulfate, Nystatin, Thiostrepton,
Triamcinolone Acetonide
140-976 Neomix® 325 Medicated Premix Neomycin Sulfate
Neomix® 325 Milk Replacer
Neomix® AG 325 Medicated Premix
Neomix® AG 325 Milk Replacer
141-003 Derm-Otic Ointment Neomycin Sulfate, Nystatin, Thiostrepton,
Triamcinolone Acetonide
200-046 Neomycin Soluble Powder 325g/lb Neomycin Sulfate
Neomycin Sulfate Soluble Powder 325 g/lb
200-050 Neomed 325 Soluble Powder Neomycin Sulfate
200-113 Biosol® Liquid Neomycin Sulfate
200-118 Neomycin Oral Solution Neomycin Sulfate
200-130 Neo-Sol 50® Neomycin Sulfate
200-153 Neo 200 Oral Solution Neomycin Sulfate
200-235 Neosol Soluble Powder Neomycin Sulfate
200-245 Derma-Vet Cream Neomycin Sulfate, Nystatin, Thiostrepton,
Triamcinolone Acetonide
200-289 NEORAL Oral Solution Neomycin Sulfate
200-330 Animax® Cream Neomycin Sulfate, Nystatin, Thiostrepton,
Triamcinolone Acetonide
200-378 Neomycin Sulfate 325 Neomycin Sulfate
200-379 Neomycin Liquid Neomycin Sulfate
Neostigmine Methylsulfate
008-097 Stiglyn 1:500 Neostigmine Methylsulfate
Nequinate
046-700 Statyl Nequinate

January 15, 2008 FDA APPROVED ANIMAL DRUG PRODUCTS 2.39


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Nicarbazin
009-476 N
icarbazin Nicarbazin
098-378 Nicarbazin / Bacitracin Premix Bacitracin Methylene Disalicylate, Nicarbazin
107-997 Medicated Broiler Feed Lincomycin Hydrochloride, Nicarbazin, Roxarsone
108-115 Nicarbazin Roxarsone Premix Nicarbazin, Roxarsone
108-116 Nicarbazin Lincomycin Premix Lincomycin Hydrochloride, Nicarbazin
135-468 Carbigran 25 Nicarbazin
Nicarbazin
138-952 M
axiban® Narasin, Nicarbazin
140-339 Flavomycin® Bambermycins, Nicarbazin
Nicarb®
140-926 BMD® / Maxiban® Bacitracin Methylene Disalicylate, Narasin,
Nicarbazin
140-942 Flavomycin® / Maxiban® Bambermycins, Narasin, Nicarbazin
140-947 L incomix® / Maxiban® Lincomycin, Narasin, Nicarbazin
141-112 3-Nitro® / BMD® / Maxiban® Bacitracin Methylene Disalicylate, Narasin,
Nicarbazin, Roxarsone
141-113 3-Nitro® / Maxiban® Narasin, Nicarbazin, Roxarsone
141-124 BMD® / Maxiban® Bacitracin Methylene Disalicylate, Narasin,
Nicarbazin
141-146 N
icarb® / Baciferm® Bacitracin Zinc, Nicarbazin
200-027 N
icarmix 25® Nicarbazin
200-164 BMD® / Nicarmix 25® Bacitracin Methylene Disalicylate, Nicarbazin
200-170 3-Nitro® / Lincomix® / Nicarmix 25® Lincomycin, Nicarbazin, Roxarsone
200-171 Lincomix® / Nicarmix 25® Lincomycin, Nicarbazin
200-172 3-Nitro® / Nicarmix 25® Nicarbazin, Roxarsone
Nitarsone
007-616 Histostat®-50 Type A Medicated Article Nitarsone
141-088 BMD® / Histostat® Bacitracin Methylene Disalicylate, Nitarsone
Nitazoxanide
141-178 Navigator® Nitazoxanide
Nitenpyram
141-175 Capstar® Nitenpyram
141-204 Sentinel® Flavor Tabs® and Capstar® Flea Management Lufenuron, Milbemycin Oxime, Nitenpyram
System™
141-205 Program® Flavor Tabs® and Capstar® Flea Management Lufenuron, Nitenpyram
System™
Nitrofurazone
011-154 NFZ® Puffer Nitrofurazone
100-854 Fura Ointment Nitrofurazone
122-447 Fura-Septin Soluble Dressing Nitrofurazone
125-797 Nitrofurazone Dressing Nitrofurazone
126-236 Nitrofurazone Soluble Powder Nitrofurazone
126-504 Nitrofurazone Ointment Nitrofurazone
130-872 Nitrofurazone Anesthetic Dress. Butacaine Sulfate, Nitrofurazone
132-427 Fura-Zone Nitrofurazone
138-657 Nitrofurazone Ointment Nitrofurazone
140-851 NFZ® Wound Dressing Nitrofurazone
140-881 Nitrofurazone Soluble Dressing Nitrofurazone
140-910 NFZ® Wound Powder Nitrofurazone

2.40 FDA APPROVED ANIMAL DRUG PRODUCTS January 15, 2008


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Nitromide
011-141 Unistat-2 Type A Medicated Premix Nitromide, Sulfanitran
039-666 Unistat-3 Type A Medicated Article Nitromide, Roxarsone, Sulfanitran
Norgestomet
134-930 Syncro-Mate-B® Estradiol Valerate, Norgestomet
Novobiocin
012-375 Albamix® Feed Medication Novobiocin
Novobiocin Sodium
013-467 A
lbamix® Susceptibility Disks Novobiocin Sodium
055-072 A
lbacillin® Suspension Novobiocin Sodium, Penicillin G Procaine
Special Formula 17900-Forte® Suspension
055-076 Albaplex® 3x Tablets Novobiocin Sodium, Tetracycline Hydrochloride
Albaplex® Tablets
055-098 Albadry Plus® Suspension Novobiocin Sodium, Penicillin G Procaine
065-090 Delta Albaplex® 3x Tablets Novobiocin Sodium, Prednisolone, Tetracycline
Delta Albaplex® Tablets Hydrochloride
065-099 A lbaplex® Capsules Novobiocin Sodium, Tetracycline Phosphate
100-808 Albamast® Suspension Novobiocin Sodium
102-511 B iodry® Suspension Novobiocin Sodium
Drygard® Suspension
Nystatin
012-258 Panolog® Ointment Neomycin Sulfate, Nystatin, Thiostrepton,
Triamcinolone Acetonide
012-680 Pharmastatin®-20 Type A Medicated Article Nystatin
096-676 Panolog® Cream Neomycin Sulfate, Nystatin, Thiostrepton,
Triamcinolone Acetonide
140-810 Derma-Vet™ Ointment Neomycin Sulfate, Nystatin, Thiostrepton,
Panavet Ointment Triamcinolone Acetonide
140-847 Animax Neomycin Sulfate, Nystatin, Thiostrepton,
Triamcinolone Acetonide
140-879 Derma 4 Ointment Neomycin Sulfate, Nystatin, Thiostrepton,
Triamcinolone Acetonide
141-003 Derm-Otic Ointment Neomycin Sulfate, Nystatin, Thiostrepton,
Triamcinolone Acetonide
200-245 Derma-Vet Cream Neomycin Sulfate, Nystatin, Thiostrepton,
Triamcinolone Acetonide
200-330 Animax® Cream Neomycin Sulfate, Nystatin, Thiostrepton,
Triamcinolone Acetonide
Oleandomycin
035-287 O
M-5 Premix Oleandomycin
Oleate Sodium
099-344 Osteum Solution 50 mg Oleate Sodium
Omeprazole
141-123 GastroGard® Omeprazole
141-227 Ulcergard® Omeprazole
Orbifloxacin
141-081 Orbax™ Tablets Orbifloxacin
Orgotein
045-863 Palosein Orgotein

January 15, 2008 FDA APPROVED ANIMAL DRUG PRODUCTS 2.41


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Ormetoprim
040-209 Rofenaid® 40 Ormetoprim, Sulfadimethoxine
041-984 Rofenaid® / Roxarsone Ormetoprim, Roxarsone, Sulfadimethoxine
100-929 Primor® Tablets Ormetoprim, Sulfadimethoxine
125-933 Romet®-30 Ormetoprim, Sulfadimethoxine
Oxfendazole
110-776 Benzelmin® Powder For Suspension Oxfendazole
110-777 Benzelmin® Top Dress. Oxfendazole
132-105 Benzelmin® Equine Anthelmic Paste Oxfendazole
Synanthic® Oral Paste
133-841 Benzelmin® Equine Anthelmintic Suspension Oxfendazole
Synanthic® Suspension
136-740 Benzelmin® Plus Paste Oxfendazole, Trichlorfon
140-854 Synanthic® Bovine Dewormer Suspension 9.06% Oxfendazole
Synanthic® Bovine Dewormer Suspension 22.5%
140-892 Synanthic® Bovine Dewormer Paste, 18.5% Oxfendazole
Oxibendazole
109-722 Anthelcide EQ® Suspension Oxibendazole
121-042 Anthelcide EQ® Paste Oxibendazole
136-483 Filaribits® Plus Chewable Tablets Diethylcarbamazine Citrate, Oxibendazole
Oxymorphone Hydrochloride
030-525 Numorphan Oxymorphone Hydrochloride
Oxytetracycline
046-718 MGA® (liquid) / Terramycin® Melengestrol Acetate, Oxytetracycline
046-719 MGA® (dry) / Terramycin® Melengestrol Acetate, Oxytetracycline
095-143 Terramycin® 50 Type A Medicated Article Oxytetracycline
Terramycin® 100 Type A Medicated Article
Terramycin® 200 Type A Medicated Article
113-232 Liquamycin® LA-200® Oxytetracycline
Terramycin LA-200® (Rx)
118-123 Encore® (Compudose 400® ) Estradiol, Oxytetracycline
138-938 Oxytetracycline - 50 Oxytetracycline
Oxytetracycline - 100
Oxytetracycline - 100MR
Pennox™ 50
Pennox™ 100
Pennox™ 100MR
Pennox™ 200
200-008 Bio-Mycin® 200 Injectable Solution Oxytetracycline
Oxy-Tet® 200 Injectable Solution
200-096 Sacox® / Terramycin® Oxytetracycline, Salinomycin Sodium
200-117 Oxyshot® LA Oxytetracycline
200-123 Maxim-200® Injection Oxytetracycline
Oxytetracycline Hydrochloride Injection 200mg
200-154 Oxytetracycline 200 Oxytetracycline
Pennox™ 200
200-306 Oxytetracycline Injection Oxytetracycline
Oxytetracycline (Monoalkyl Trimethyl Ammonium Salt)
099-006 Terramycin® TM-50 Monensin Sodium, Oxytetracycline (Monoalkyl
TM-10 Plus Trimethyl Ammonium Salt)
101-666 Oxytetracycline / Robenz® Premix Oxytetracycline (Monoalkyl Trimethyl Ammonium
Salt), Robenidine Hydrochloride

2.42 FDA APPROVED ANIMAL DRUG PRODUCTS January 15, 2008


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Oxytetracycline (Monoalkyl Trimethyl Ammonium Salt), cont.
140-448 Bio-Cox® / Terramycin® Oxytetracycline (Monoalkyl Trimethyl Ammonium
Salt), Salinomycin Sodium
140-579 Bovatec® / Terramycin® Lasalocid, Oxytetracycline (Monoalkyl Trimethyl
Ammonium Salt)
Oxytetracycline Dihydrate
038-439 Terramycin® for Fish Oxytetracycline Dihydrate
141-211 Mecadox® 10 / Terramycin® 50 Carbadox, Oxytetracycline Dihydrate
Mecadox® 10 / Terramycin® 100
Mecadox® 10 / Terramycin® 200
200-128 Agrimycin® - 200 Oxytetracycline Dihydrate
Oxytetracycline Hydrochloride
007-879 Terramycin® Vet Capsules Oxytetracycline Hydrochloride
008-622 Terramycin® Animal Formula Oxytetracycline Hydrochloride
Terramycin® Soluble Powder
008-763 Terramycin® Ophthalmic Ointment with Polymyxin Oxytetracycline Hydrochloride, Polymyxin B Sulfate
008-769 Liquamycin® Injectable Oxytetracycline Hydrochloride
Terramycin® Injectable
008-804 Terramycin® Oxytetracycline Hydrochloride
Terramycin® 10 Type A Medicated Articles
Terramycin® 20 Type A Medicated Articles
Terramycin® 50 Type A Medicated Article
Terramycin® 100 Type A Medicated Article
Terramycin® 100D Type A Medicated Article
Terramycin® 100SS Type A Medicated Article
Terramycin® 200 Type A Medicated Article
011-060 Terramycin® Scour Tablets Oxytetracycline Hydrochloride
013-146 Liquamycin® Intramuscular Lidocaine, Oxytetracycline Hydrochloride
013-293 Liqua-Cortril Spray Hydrocortisone, Oxytetracycline Hydrochloride
Terra-Cortril Spray
032-946 Magna Terramycin® Soluble Powder Carbomycin, Oxytetracycline Hydrochloride
038-200 Medamycin Soluble Antibiotic Oxytetracycline Hydrochloride
OXY WS™ Soluble Antibiotic
045-143 Oxyject® Oxytetracycline Hydrochloride
047-278 Bio-Mycin® Oxytetracycline Hydrochloride
Oxy-Tet™ 50
048-287 Oxytetracycline-50 Oxytetracycline Hydrochloride
049-948 Aquachel 100 mg Lidocaine, Oxytetracycline Hydrochloride
091-127 Rachelle Oxyvet Injection Oxytetracycline Hydrochloride
094-114 Liquamycin® 100 Oxytetracycline Hydrochloride
Terramycin® 100
095-642 Bio-Mycin C Oxytetracycline Hydrochloride
Oxy-Tet™ Injection
097-452 Oxyject® 100 Oxytetracycline Hydrochloride
099-402 Aquachel-100 Oxytetracycline Hydrochloride
Oxyvet-100
103-758 Terramycin® Premix Oxytetracycline Hydrochloride
108-963 Medamycin® Injectable Oxytetracycline Hydrochloride
130-435 Oxy-Tet™ Soluble Oxytetracycline Hydrochloride
OxyMarine™

Tetravet-CA

January 15, 2008 FDA APPROVED ANIMAL DRUG PRODUCTS 2.43


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Oxytetracycline Hydrochloride
140-582 Biocyl 50 Oxytetracycline Hydrochloride
Biocyl 100
Oxytetracycline Hydrochloride
141-002 OXY 500 Calf Bolus Oxytetracycline Hydrochloride
OXY 1000 Calf Bolus
141-143 Oxytetracycline Injection 300 mg/ml (OTC) Oxytetracycline Hydrochloride
Tetradure™ 300 (Rx)
200-026 Pennox™ 343 Oxytetracycline Hydrochloride
200-066 Agrimycin™ - 343 Soluble Powder Oxytetracycline Hydrochloride
200-068 Oxytetracycline Hydrochloride Injection Oxytetracycline Hydrochloride
200-144 TETROXY® HCA-1772 Oxytetracycline Hydrochloride
Tetroxy® HCA-280
200-146 Oxytetracycline HCl Soluble Powder Oxytetracycline Hydrochloride
200-247 Oxytetracycline HCl Soluble Powder-343 Oxytetracycline Hydrochloride
200-305 Oxytetracycline Hydrochloride Soluble Powder Oxytetracycline Hydrochloride
200-452 OxyTet™ Oxytetracycline Hydrochloride
200-460 Tetroxy® Aquatic Oxytetracycline Hydrochloride
Oxytocin
046-788 Oxytocin Injection Oxytocin
046-822 Vetocin Injection Oxytocin
099-169 Oxytocin (Label Under Distributors) Oxytocin
109-305 Oxytocin Injectable Oxytocin
124-241 PVL Oxytocin Injectable Oxytocin
130-136 Oxytocin Injection Oxytocin
200-328 Oxytocin Injection Oxytocin
Penicillin G Benzathine
065-087 Longicil Fortified Penicillin G Benzathine, Penicillin G Procaine
065-169 Dura-biotic Penicillin G Benzathine, Penicillin G Procaine
Flo-cillin®
065-488 Benza-Pen Penicillin G Benzathine, Penicillin G Procaine
065-498 Dual-Cillin™ Penicillin G Benzathine, Penicillin G Procaine
Pen BP-48
065-500 Penicillin G Procaine Aqueous Penicillin G Benzathine, Penicillin G Procaine
Sterile Penicillin G Benzathine
065-506 Combi-PEN-48 Penicillin G Benzathine, Penicillin G Procaine
Combicillin® (Rx)
Penicillin G Potassium
055-060 Penicillin G Potassium Penicillin G Potassium
USP
065-276 Veesyn Granules for Oral Soln Penicillin G Potassium
200-103 PenAqua Sol-G™ Penicillin G Potassium
200-106 R-Pen Penicillin G Potassium
200-122 Solu-Pen Penicillin G Potassium
200-307 Penicillin G Potassium, USP Penicillin G Potassium
200-347 Penicillin G Potassium USP Penicillin G Potassium
200-372 Han-Pen™ Penicillin G Potassium
Penicillin G Procaine
035-688 Aureo S-P 250® Chlortetracycline Calcium Complex, Penicillin G
Aureomix 500 Procaine, Sulfamethazine
039-077 CSP™ 250 Chlortetracycline Hydrochloride, Penicillin G
CSP™ 500 Procaine, Sulfathiazole

2.44 FDA APPROVED ANIMAL DRUG PRODUCTS January 15, 2008


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Penicillin G Procaine, cont.
046-666 Penicillin 100 Type A Medicated Article Penicillin G Procaine
Penicillin G Procaine 50 Type A Medicated Article
046-668 Penicillin G Procaine 50% Type A Medicated Article Penicillin G Procaine
055-028 Quartermaster® Dry Cow Treatment Dihydrostreptomycin Sulfate, Penicillin G Procaine
055-072 Albacillin® Suspension Novobiocin Sodium, Penicillin G Procaine
Special Formula 17900-Forte® Suspension
055-097 Dry-Mast Dihydrostreptomycin Sulfate, Penicillin G Procaine
055-098 Albadry Plus® Suspension Novobiocin Sodium, Penicillin G Procaine
065-010 Agricillin Pen Aqueous Penicillin G Procaine
Aqua-Cillin
Penicillin G Co-op
065-081 Go-Dry Penicillin G Procaine
Hanfords Penicillin
Masti-Clear
065-087 Longicil Fortified Penicillin G Benzathine, Penicillin G Procaine
065-110 Pro-Pen G In Aqueous Suspension Penicillin G Procaine
065-119 Forte Topical® Ointment Hydrocortisone Acetate, Neomycin Sulfate, Penicillin
G Procaine, Polymyxin B Sulfate
065-130 Crystalline Pro Penicillin G Penicillin G Procaine
065-169 Dura-biotic Penicillin G Benzathine, Penicillin G Procaine
Flo-cillin®
065-174 Crysticillin Penicillin G Procaine
065-383 Formula A-34 Penicillin G Procaine
Uni Biotic 4 Dose
065-465 Aqua-Mast Penicillin G Procaine
Hanfords Four-Pen
065-488 Benza-Pen Penicillin G Benzathine, Penicillin G Procaine
065-493 Jetpen Penicillin G Procaine
065-498 Dual-Cillin™ Penicillin G Benzathine, Penicillin G Procaine
Pen BP-48
065-500 Penicillin G Procaine Aqueous Penicillin G Benzathine, Penicillin G Procaine
Sterile Penicillin G Benzathine
065-505 Pro-Pen G Penicillin G Procaine
065-506 Combi-PEN-48 Penicillin G Benzathine, Penicillin G Procaine
Combicillin® (Rx)
091-668 Chlorachel™ 250 Swine / Pficlor SP 250 Chlortetracycline Calcium Complex, Penicillin G
ChlorMax™ / SP 250 Procaine, Sulfamethazine
ChlorMax™ / SP 500
ChlorMax™ / SP 1000
138-934 Pennchlor SP 250 Chlortetracycline Calcium Complex, Penicillin G
Pennchlor SP 500 Procaine, Sulfamethazine
200-140 Aureozol® Chlortetracycline Hydrochloride, Penicillin G
Procaine, Sulfathiazole
200-167 Aureozol® 500 Granular Chlortetracycline Calcium Complex, Penicillin G
Procaine, Sulfathiazole
Penicillin V Potassium
065-275 Penicillin VK Filmtab 250 mg Penicillin V Potassium
Pentazocine Lactate
044-611 Talwin®-V Sterile Aqueous Injection Pentazocine Lactate
Pentobarbital
046-789 C
hloropent Chloral Hydrate, Magnesium Sulfate, Pentobarbital

January 15, 2008 FDA APPROVED ANIMAL DRUG PRODUCTS 2.45


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Pentobarbital Sodium
004-536 Somnopentyl Injection Pentobarbital Sodium
010-346 Combuthal Powder Pentobarbital Sodium, Thiopental Sodium
119-807 Beuthanasia-D Special Pentobarbital Sodium, Phenytoin Sodium
200-071 Euthasol® Pentobarbital Sodium, Phenytoin Sodium
200-280 Euthanasia-III Solution Pentobarbital Sodium, Phenytoin Sodium
Phenothiazine
015-154 Dyrex T.F - 200 Phenothiazine, Piperazine Dihydrochloride,
Dyrex T.F - 500 Trichlorfon
Dyrex T.F - 1000
033-149 Parvex Plus® Suspension Phenothiazine, Piperazine-carbon Disulfide Complex
Phenylbutazone
010-987 Butazolidin® Bolus Phenylbutazone
Butazolidin® Tablets
011-575 Butazolidin® Injectable 20% Phenylbutazone
038-800 Butazolidin® Granules Phenylbutazone
044-756 Butatron™ Phenylbutazone
045-416 Tevcodyne Injectable Phenylbutazone
045-514 EquiBute Injection Phenylbutazone
045-515 EquiBute Tablets 100 mg Phenylbutazone
046-780 Phen-Buta Vet Injection Phenylbutazone
047-712 Bizolin®-100 Phenylbutazone
Bizolin®-200
048-647 Pributazone™ Tablets Phenylbutazone
Therazone Tablets
049-187 Phen-Buta Vet Tablets Phenylbutazone
Phenylbutazone Tablets (Horses)
091-065 Robizone-V Phenylbutazone
091-818 Phenylbutazone Tablets Phenylbutazone
USP 1 gram
Phenylbute™
093-105 Robizone-V Phenylbutazone
093-516 Bizolin Injection 20% Phenylbutazone
094-170 Phenylbutazone Tablets, USP 100 mg Phenylbutazone
Phenylbutazone Tablets, USP 200 mg
Phenylbute™ Tablets 100 mg
096-671 Phen-Buta-Vet Injection Phenylbutazone
096-672 Phen-Buta-Vet Tablets Phenylbutazone
Phenylbutazone S/A
098-640 Robizone Injectable 20% Phenylbutazone
099-618 Bizolin® 1-G Phenylbutazone
102-824 Phenylbutazone Tablets Phenylbutazone
113-510 Equipalazone Phenylbutazone
116-087 Butazolidin® Phenylbutazone
Butazolidin® Paste
Bute
Phenylbute™ Paste
Phenylzone® Paste
118-979 Butatron Gel Phenylbutazone
140-958 Equiphen® Paste Phenylbutazone
200-126 Phenylbutazone 20% Injection Phenylbutazone
200-266 Butequine® Phenylbutazone

2.46 FDA APPROVED ANIMAL DRUG PRODUCTS January 15, 2008


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Phenylbutazone, cont.
200-323 Phenylbutazone Tablets Phenylbutazone
200-333 Superiorbut® Phenylbutazone
200-334 Equizone 100™ Phenylbutazone
200-371 Phenylbutazone 20% Injection Phenylbutazone
Phenytoin Sodium
119-807 Beuthanasia-D Special Pentobarbital Sodium, Phenytoin Sodium
200-071 Euthasol® Pentobarbital Sodium, Phenytoin Sodium
200-280 Euthanasia-III Solution Pentobarbital Sodium, Phenytoin Sodium
Phosmet
044-757 P
rolate I-E Phosmet
Pimobendan
141-273 V
etmedin® Pimobendan
Piperazine Citrate
012-469 Dizan Suspension With Piperazine Dithiazanine Iodide, Piperazine Citrate
047-333 Equizole® A Liquid Piperazine Citrate, Thiabendazole
092-709 Sergeants® Worm Away For Dogs Piperazine Citrate
092-710 Sergeants® Worm Away For Cats Piperazine Citrate
Piperazine Dihydrochloride
015-154 Dyrex T.F - 200 Phenothiazine, Piperazine Dihydrochloride,
Dyrex T.F - 500 Trichlorfon
Dyrex T.F - 1000
092-237 Ripercol L-Piperazine Soluble Levamisole Hydrochloride, Piperazine
Dihydrochloride
093-688 Ripercol L-Piperazine Levamisole Hydrochloride, Piperazine
Dihydrochloride
Piperazine Hydrochloride
010-005 P
ig Wormer Dipiperazine Sulfate, Piperazine Hydrochloride
Wazine®
Wazine-34
Piperazine Monohydrochloride
125-730 Purina® Liquid Dog Wormer Piperazine Monohydrochloride
Piperazine Phosphate
037-410 Equizole® A Piperazine Phosphate, Thiabendazole
091-260 Pulvex Worm Caps. Piperazine Phosphate
101-161 Thenatol PW Tablets Piperazine Phosphate, Thenium Closylate
Piperazine-carbon Disulfide Complex
011-299 Parvex® Suspension Piperazine-carbon Disulfide Complex
011-590 Parvex® Bolus Piperazine-carbon Disulfide Complex
033-149 Parvex Plus® Suspension Phenothiazine, Piperazine-carbon Disulfide Complex
Pirlimycin Hydrochloride
141-036 Pirsue® Aqueous Gel Pirlimycin Hydrochloride
Pirsue® Sterile Solution
Pituitary Luteinizing Hormone
009-167 P
.L.H. Injectable Pituitary Luteinizing Hormone
Poloxalene
032-704 Bloat Guard Top Dressing Poloxalene
033-760 Bloat Guard Drench Concentrate Poloxalene
033-773 EASYLIX Bloat Guard Pressed Block Poloxalene
Sweetlix Bloat Guard Block

January 15, 2008 FDA APPROVED ANIMAL DRUG PRODUCTS 2.47


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Poloxalene, cont.
038-281 Bloat Guard Liquid Premix 1.65 Poloxalene
Bloat Guard Liquid Premix 2.2
039-729 Therabloat® Poloxalene
140-869 Purina® Bloat Block Poloxalene
Purina® Saf-T-Block Bg
Polymyxin B Sulfate
008-763 Terramycin® Ophthalmic Ointment with Polymyxin Oxytetracycline Hydrochloride, Polymyxin B Sulfate
038-801 Anaprime® Ophthalmic Solution Flumethasone, Neomycin Sulfate, Polymyxin B
Sulfate
049-725 Anaprime® Opthakote Ophthalmic Flumethasone, Neomycin Sulfate, Polymyxin B
Sulfate
049-726 Optiprime® Opthakote Ophthalmic Solution Neomycin Sulfate, Polymyxin B Sulfate
065-015 Bacitracin-Neomycin-Polymyxin with Hydrocortisone Bacitracin Zinc, Hydrocortisone Acetate, Neomycin
Acetate Ophthalmic Ointment Sulfate, Polymyxin B Sulfate
Vetropolycin HC Ophthalmic Ointment
065-016 Bac-Neo-Poly Ophthalmic Ointment Bacitracin Zinc, Neomycin Sulfate, Polymyxin B
Vetropolycin Ophthalmic Ointment Sulfate
065-114 Mycitracin® Sterile Ophthalmic Ointment Bacitracin Zinc, Neomycin Sulfate, Polymyxin B
Sulfate
065-119 Forte Topical® Ointment Hydrocortisone Acetate, Neomycin Sulfate, Penicillin
G Procaine, Polymyxin B Sulfate
065-476 Cortisporin Veterinary Ophthalmic Ointment Bacitracin Zinc, Hydrocortisone Acetate, Neomycin
Sulfate, Polymyxin B Sulfate
065-485 Neosporin Ophthalmic Ointment Bacitracin Zinc, Neomycin Sulfate, Polymyxin B
Sulfate
Polyoxyethylene 23 Lauryl Ether
136-214 Enproal Bloat Blox Polyoxyethylene 23 Lauryl Ether
Polysulfated Glycosaminoglycan
136-383 Adequan® Injectable Polysulfated Glycosaminoglycan
140-901 Adequan® Polysulfated Glycosaminoglycan
141-038 Adequan® Canine Polysulfated Glycosaminoglycan
Ponazuril
141-188 Marquis™ Antiprotozoal Oral Paste Ponazuril
Porcine Insulin Zinc
141-236 Vetsulin® Porcine Insulin Zinc
Potassium Citrate
125-961 e-Sorb
R Citric Acid, Dextrose, Glycine, Potassium Citrate,
Vy'trate Potassium Phosphate, Sodium Chloride
Potassium Phosphate
125-961 e-Sorb
R Citric Acid, Dextrose, Glycine, Potassium Citrate,
Vy'trate Potassium Phosphate, Sodium Chloride
Pralidoxime Chloride
039-204 P
rotopam Pralidoxime Chloride
Praziquantel
111-607 Droncit® 5.68% Injectible Solution Praziquantel
111-798 Cutter Tape-Tabs (OTC) Praziquantel
Droncit® Canine Cestocide Tablets
Droncit® Canine Tablets (Rx)
Droncit® Feline Cestocide Tablets
133-953 Vercom Paste Anthelmintic Febantel, Praziquantel

2.48 FDA APPROVED ANIMAL DRUG PRODUCTS January 15, 2008


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Praziquantel, cont.
141-007 Drontal® Plus Broad Spectrum Anthelmintic Tablets Febantel, Praziquantel, Pyrantel Pamoate
Drontal® Plus Tablets
Drontal® Plus Taste Tabs®
141-008 Drontal® Praziquantel, Pyrantel Pamoate
141-214 Zimecterin® Gold Paste Ivermectin, Praziquantel
141-215 Equimax™ Paste Ivermectin, Praziquantel
141-216 Quest® Plus Gel Moxidectin, Praziquantel
141-257 Iverhart Max™ Ivermectin, Praziquantel, Pyrantel Pamoate
141-261 WormXPlus™ Praziquantel, Pyrantel Pamoate
141-275 Profender® Emodepside, Praziquantel
200-176 Prazitech™ Praziquantel
200-265 Prazi-C Tablets (OTC) Praziquantel
Praziquantel Tablets (Rx)
Prednisolone
012-437 Temaril-P® Tablets Prednisolone, Trimeprazine Tartrate
032-322 Liquisone F with Cerumene Hexamethyltetracosane, Neomycin Sulfate,
Prednisolone, Tetracaine
035-161 Temaril-P® Spansule Capsule No. 1 Prednisolone, Trimeprazine Tartrate
Temaril-P® Spansule Capsule No. 2
065-090 Delta Albaplex® 3x Tablets Novobiocin Sodium, Prednisolone, Tetracycline
Delta Albaplex® Tablets Hydrochloride
140-921 PrednisTab® Prednisolone
Prednisolone Acetate
010-312 Meticortelone Acetate Prednisolone Acetate
011-703 Neo-Delta-Cortef® with Tetracaine Ointment Neomycin Sulfate, Prednisolone Acetate, Tetracaine
Hydrochloride
045-288 Optisone Neomycin Sulfate, Prednisolone Acetate
065-259 Chlorasone Ophthalmic Ointment Chloramphenicol, Prednisolone Acetate
091-534 Neo-Delta Cortef® Sterile Solution Neomycin Sulfate, Prednisolone Acetate
Prednisolone Sodium Phosphate
011-437 Hydeltrone Ointment Neomycin Sulfate, Prednisolone Sodium Phosphate
098-288 Prednis-A-Vet Injection Prednisolone Sodium Phosphate
Prednisolone Sodium Succinate
011-593 Solu-Delta Cortef® Sterile Powder Prednisolone Sodium Succinate
Prednisolone Tertiary Butylacetate
011-080 H
ydeltrone-TBA Suspension Prednisolone Tertiary Butylacetate
Prednisone
009-963 Meticorten® Prednisone
Primidone
009-392 Primidone Primidone
010-091 Mylepsin Tablets Primidone
030-137 Mylepsin Primidone
Primidone Medi-Pets
117-689 Neurosyn Tablets Primidone
Prochlorperazine Dimaleate
031-914 Neo-Darbazine Spansule Capsule No.1 Isopropamide Iodide, Neomycin Sulfate,
Neo-Darbazine Spansule Capsule No.3 Prochlorperazine Dimaleate
Prochlorperazine Edisylate
015-147 D
arbazine Injectable Isopropamide Iodide, Prochlorperazine Edisylate

January 15, 2008 FDA APPROVED ANIMAL DRUG PRODUCTS 2.49


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Prochlorperazine Maleate
013-201 Darbazine Spansule No.1 Isopropamide Iodide, Prochlorperazine Maleate
Darbazine Spansule No.3
Progesterone
009-576 Synovex®-C Estradiol Benzoate, Progesterone
Synovex®-S
110-315 Component® E-C with Tylan® Estradiol Benzoate, Progesterone, Tylosin Tartrate
Component® E-S with Tylan®
141-200 EAZI-Breed™ CIDR® Cattle Insert Progesterone
Promazine Hydrochloride
011-241 Promazine HCl Injectable Promazine Hydrochloride
012-656 Promazine Granules Promazine Hydrochloride
092-116 Ketaset® Plus Aminopentamide Hydrogen Sulfate, Ketamine
Hydrochloride, Promazine Hydrochloride
119-141 Tranquazine Injection Promazine Hydrochloride
Proparacaine Hydrochloride
009-035 Ophthaine® Solution Proparacaine Hydrochloride
Propiopromazine Hydrochloride
041-665 Tranvet Chewable Tablets (20 mg) Propiopromazine Hydrochloride
045-716 Tranvet Injectable Solution Propiopromazine Hydrochloride
Propofol
141-070 Rapinovet® Propofol
141-098 PropoFlo™ Propofol
Prostalene
100-254 Synchrocept Solution Prostalene
Pyrantel Pamoate
091-739 Strongid® T Pyrantel Pamoate
100-237 Nemex Pyrantel Pamoate
Nemex-2
RFD Liquid Wormer
101-331 Dog Wormer Tablets Pyrantel Pamoate
129-831 Banminth®-P Paste Pyrantel Pamoate
Strongid® Paste
139-191 D-Worm™ Pyrantel Pamoate
Dog Wormer Chewable Tablets
140-971 Heartgard® Plus Ivermectin, Pyrantel Pamoate
Heartgard® Plus For Dogs
141-007 Drontal® Plus Broad Spectrum Anthelmintic Tablets Febantel, Praziquantel, Pyrantel Pamoate
Drontal® Plus Tablets
Drontal® Plus Taste Tabs®
141-008 Drontal® Praziquantel, Pyrantel Pamoate
141-257 Iverhart Max™ Ivermectin, Praziquantel, Pyrantel Pamoate
141-261 WormXPlus™ Praziquantel, Pyrantel Pamoate
200-007 Liqui-Vict 2X™ Pyrantel Pamoate

2.50 FDA APPROVED ANIMAL DRUG PRODUCTS January 15, 2008


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Pyrantel Pamoate, cont.
200-028 Evict® Pyrantel Pamoate
Evict® DS™ Wormer For Puppies and Dogs
Evict® Liquid Wormer For Puppies and Dogs
Lassie®
Lassie® DS Liquid Wormer For Puppies and Dogs
Lassie® Liquid Wormer For Puppies and Dogs
Vet's Own™
Vet's Own™ Canine Anthelmintic Suspension
Vet's Own™ DS Canine Anthelmintic Suspension
200-246 Anthelban V (Rx) Pyrantel Pamoate
Pyrantel Pamoate Equine Anthelmintic Suspension (OTC)
Pyrantel Pamoate Oral Suspension (Rx)
200-248 Pyrantel Pamoate Suspension Pyrantel Pamoate
Pyrantel Pamoate Suspension-2.27mg
Pyrantel Pamoate Suspension-4.54mg
200-281 Wormexx™ Chewable Tablets Pyrantel Pamoate
200-302 Iverhart™ Plus Flavored Chewables Flavored Tablets Ivermectin, Pyrantel Pamoate
200-338 Tri-Heart Plus Chewable Tablets Ivermectin, Pyrantel Pamoate
200-342 Pyrantel Pamoate Paste Pyrantel Pamoate
200-350 Exodus™ Paste Pyrantel Pamoate
200-352 Primex™ 2-X Pyrantel Pamoate
Primex™ Canine
200-353 Primex™ Equine Pyrantel Pamoate
200-445 Primex® Pyrantel Pamoate
Pyrantel Tartrate
042-888 Banminth® (5.66 g) Pyrantel Tartrate
Strongid® (5.66 g)
043-290 Banminth® Premix 80 Pyrantel Tartrate
092-150 Purina® Horse & Colt Wormer Pyrantel Tartrate
092-955 Banminth® / Mecadox® Carbadox, Pyrantel Tartrate
097-258 Purina® Ban Worm For Pigs Pyrantel Tartrate
110-047 Banminth® Tylan® Pyrantel Tartrate, Tylosin Phosphate
116-044 Banminth® / Lincomix® Lincomycin Hydrochloride Monohydrate, Pyrantel
Tartrate
118-814 Worm-Ban 10 Pyrantel Tartrate
Worm-Ban 5
118-815 Q.T. Ban-Tech Pyrantel Tartrate
118-877 Ban-A-Worm Py. Tartrate Pyrantel Tartrate
Ban-A-Worm Pyrantel Tartrate Ton Pack
119-062 Cadco-BN-5 Banminth® Premix Pyrantel Tartrate
Cadco-BN-10 Banminth® Premix
121-337 INI Swine Ban-Wormer B-9 19.2 BA. Pyrantel Tartrate
INI Swine Ban-Wormer B-9.6 BA.
123-000 Super Swine Wormer B-9 19.2 Banm. Pyrantel Tartrate
Super Swine Wormer B-9.6 Banm.
129-415 Custom Ban Wormer 9.6 Banminth® Pyrantel Tartrate
Custom Ban Wormer 19.2 Banminth®
132-136 Ban-A-Worm II Pyrantel Tartrate
133-490 Ban-D-Wormer II Banminth® Pyrantel Tartrate
135-243 Swine Guard-BN Banminth® Premix Pyrantel Tartrate
135-941 Check-E-Ton BM Pyrantel Tartrate

January 15, 2008 FDA APPROVED ANIMAL DRUG PRODUCTS 2.51


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Pyrantel Tartrate, cont.
138-941 Banminth® / Lincomix® Lincomycin Hydrochloride Monohydrate, Pyrantel
Banminth® / Lincomix® 20 Tartrate
140-819 Strongid® 48 Pyrantel Tartrate
140-825 B anminth® Intermediate Premix Pyrantel Tartrate
Swine Wormer-B
200-168 CW 48 (Type A Medicated Article) Pyrantel Tartrate
200-282 C ontinuex™ Pyrantel Tartrate
Pyrilamine Maleate
046-288 Histavet-P® Pyrilamine Maleate
138-405 Pyrilamine Maleate Injection Pyrilamine Maleate
Pyrimethamine
141-240 ReBalance™ Antiprotozoal Oral Suspension Pyrimethamine, Sulfadiazine Sodium
Ractopamine Hydrochloride
140-863 Paylean® 9 Ractopamine Hydrochloride
Paylean® 45
141-172 Paylean® / Tylan® Ractopamine Hydrochloride, Tylosin Phosphate
141-221 Optaflexx™ 45 Ractopamine Hydrochloride
141-224 Optaflexx™ / Rumensin® / Tylan® Monensin Sodium, Ractopamine Hydrochloride,
Tylosin Phosphate
141-225 Optaflexx™ / Rumensin® Monensin Sodium, Ractopamine Hydrochloride
141-233 Optaflexx™ / Rumensin® / Tylan® / MGA® Melengestrol Acetate, Monensin Sodium,
Ractopamine Hydrochloride, Tylosin Phosphate
141-234 Optaflexx™ / Rumensin® / MGA® Melengestrol Acetate, Monensin Sodium,
Ractopamine Hydrochloride
200-424 HeifermaX™ / Optaflexx® / Rumensin® / Tylan® Melengestrol Acetate, Monensin Sodium,
Ractopamine Hydrochloride, Tylosin Phosphate
200-448 HeifermaX® / Optaflexx® / Rumensin® Melengestrol Acetate, Monensin Sodium,
Ractopamine Hydrochloride
Robenidine Hydrochloride
048-486 R
obenz® Robenidine Hydrochloride
092-507 Robenz® / Aureomycin® 500 Gm Chlortetracycline Calcium Complex, Robenidine
Hydrochloride
093-106 Lincomix® / Robenz® Lincomycin Hydrochloride, Robenidine
Hydrochloride
095-546 Robenz® / Roxarsone Robenidine Hydrochloride, Roxarsone
096-933 Robenz® / Zn Bacitracin Bacitracin Zinc, Robenidine Hydrochloride
097-085 Bac MD / Robenz® Bacitracin Methylene Disalicylate, Robenidine
Hydrochloride
101-666 Oxytetracycline / Robenz® Premix Oxytetracycline (Monoalkyl Trimethyl Ammonium
Salt), Robenidine Hydrochloride
141-154 BMD® / Robenz® Bacitracin Methylene Disalicylate, Robenidine
Hydrochloride
141-155 3-Nitro® / BMD® / Robenz® Bacitracin Methylene Disalicylate, Robenidine
Hydrochloride, Roxarsone
200-212 Albac® / Robenz® Bacitracin Zinc, Robenidine Hydrochloride
Romifidine Hydrochloride
141-229 Sedivet® 1% Injection Romifidine Hydrochloride
Roxarsone
005-414 Ren-O-Sal® Tablets Roxarsone
006-019 Zoco Poultry Tablets Roxarsone
Zuco Tablets for Poultry

2.52 FDA APPROVED ANIMAL DRUG PRODUCTS January 15, 2008


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Roxarsone, cont.
006-081 Korum Improved Formula Roxarsone
007-891 3-Nitro® 10 Type A Medicated Article Roxarsone
3-Nitro® 20 Type A Medicated Article
3-Nitro® 50 Type A Medicated Article
3-Nitro® 80 Type A Medicated Article
008-274 Pig Scour Tablets Roxarsone
013-461 Broiler PMX No.1620 Amprolium, Ethopabate, Roxarsone
034-536 Aklomix Type A Medicated Article Aklomide, Roxarsone
Aklomix-3
034-537 Novastat-3 Type A Medicated Article Aklomide, Roxarsone, Sulfanitran
039-284 Swisher Super Broiler 300-108 Amprolium, Bacitracin Zinc, Ethopabate, Roxarsone
Swisher Super Broiler 400-112
039-666 Unistat-3 Type A Medicated Article Nitromide, Roxarsone, Sulfanitran
040-264 Coyden 25® / 3-Nitro® Clopidol, Roxarsone
040-435 3-Nitro® / Deccox® Decoquinate, Roxarsone
041-178 Amprol® Plus / Lincomix® / Roxarsone Amprolium, Ethopabate, Lincomycin Hydrochloride
Monohydrate, Roxarsone
041-500 Coban® - 1 Monensin Sodium, Roxarsone
041-541 BMD® 15 / Coyden 25® Bacitracin Methylene Disalicylate, Clopidol,
Roxarsone
041-984 Rofenaid® / Roxarsone Ormetoprim, Roxarsone, Sulfadimethoxine
044-016 Coyden 25® / Roxarsone / Bacitracin Zinc Bacitracin Zinc, Clopidol, Roxarsone
049-179 Amprol HI-E® / Roxarsone Amprolium, Ethopabate, Roxarsone
049-180 Amprol HI-E® / BMD® / Roxarsone Amprolium, Bacitracin Methylene Disalicylate,
Ethopabate, Roxarsone
049-464 Monensin / Bacitracin / Roxarsone Bacitracin Methylene Disalicylate, Monensin,
Roxarsone
091-326 3-Nitro® / Deccox® / Albac® Bacitracin Zinc, Decoquinate, Roxarsone
092-953 Roxarsone 10% Type A Medicated Article Roxarsone
Roxarsone 20% Type A Medicated Article
Roxarsone 50% Type A Medicated Article
093-025 3-Nitro® Soluble Roxarsone
3-Nitro® W
095-546 Robenz® / Roxarsone Robenidine Hydrochloride, Roxarsone
095-547 3-Nitro® / Amprol HI-E® / Flavomycin® Amprolium, Bambermycins, Ethopabate, Roxarsone
095-548 3-Nitro® / Amprol / Flavomycin® Amprolium, Bambermycins, Roxarsone
095-549 3-Nitro® / Amprol / Flavomycin® Amprolium, Bambermycins, Ethopabate, Roxarsone
098-341 3-Nitro® / Coban® / Flavomycin® Bambermycins, Monensin, Roxarsone
101-628 3-Nitro® / Flavomycin® / Zoalene Bambermycins, Roxarsone, Zoalene
102-485 3-Nitro® / Avatec® Lasalocid, Roxarsone
105-758 Amprol HI-E® / Baciferm® / 3-Nitro® Amprolium, Bacitracin Zinc, Ethopabate, Roxarsone
107-997 Medicated Broiler Feed Lincomycin Hydrochloride, Nicarbazin, Roxarsone
108-115 Nicarbazin Roxarsone Premix Nicarbazin, Roxarsone
112-661 3-Nitro® / Avatec® / Lincomycin Lasalocid, Lincomycin Hydrochloride, Roxarsone
112-687 3-Nitro® / Avatec® / Flavomycin® Bambermycins, Lasalocid, Roxarsone
116-082 3-Nitro® / Avatec® / BMD® Bacitracin Methylene Disalicylate, Lasalocid,
Roxarsone
116-088 3-Nitro® / BMD® / Coban® Bacitracin Methylene Disalicylate, Monensin
3-Nitro® / Coban® / Fortracin Sodium, Roxarsone
120-724 3-Nitro® / Stafac® / Coban® Monensin Sodium, Roxarsone, Virginiamycin
123-154 3-Nitro®-10 / Baciferm® / Coban® Premix Bacitracin Zinc, Monensin Sodium, Roxarsone

January 15, 2008 FDA APPROVED ANIMAL DRUG PRODUCTS 2.53


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Roxarsone, cont.
126-052 3-Nitro® / Avatec® / Baciferm® Bacitracin Zinc, Lasalocid, Roxarsone
131-894 3-Nitro® / Avatec® / Fortracin Broiler Premix Bacitracin Methylene Disalicylate, Lasalocid,
Roxarsone
132-447 Bio-Cox® / Roxarsone Roxarsone, Salinomycin Sodium
134-185 3-Nitro® / Bio-Cox® / Flavomycin® Bambermycins, Roxarsone, Salinomycin Sodium
135-321 3-Nitro® / Bio-Cox® / BMD® Bacitracin Methylene Disalicylate, Roxarsone,
Salinomycin Sodium
137-536 3-Nitro® / Albac® / Bio-Cox® Bacitracin Zinc, Roxarsone, Salinomycin Sodium
138-703 3-Nitro® / Albac® / Coban® Bacitracin Zinc, Monensin Sodium, Roxarsone
138-953 3-Nitro® / Bio-Cox® / Stafac® Type A Medicated Articles Roxarsone, Salinomycin Sodium, Virginiamycin
139-190 3-Nitro® / Bio-Cox® / Baciferm® Bacitracin Zinc, Roxarsone, Salinomycin Sodium
140-445 Monteban® / Roxarsone Narasin, Roxarsone
140-533 3-Nitro® / BMD® / Stenorol® Bacitracin Methylene Disalicylate, Halofuginone
Hydrobromide, Roxarsone
140-581 3-Nitro® / Bio-Cox® / Lincomix® Lincomycin Hydrochloride, Roxarsone, Salinomycin
Sodium
140-843 3-Nitro® / Flavomycin® / Monteban® Bambermycins, Narasin, Roxarsone
140-852 3-Nitro® / BMD® / Monteban® Bacitracin Methylene Disalicylate, Narasin,
Roxarsone
140-867 Aureomycin® / Bio-Cox® / 3-Nitro® Chlortetracycline Calcium Complex, Roxarsone,
Salinomycin Sodium
141-058 3-Nitro® / Aviax™ / BMD® Bacitracin Methylene Disalicylate, Roxarsone,
Semduramicin Sodium
141-066 3-Nitro® / Aviax™ Roxarsone, Semduramicin Sodium
141-100 3-Nitro® / BMD® / Deccox® Bacitracin Methylene Disalicylate, Decoquinate,
Roxarsone
141-112 3-Nitro® / BMD® / Maxiban® Bacitracin Methylene Disalicylate, Narasin,
Nicarbazin, Roxarsone
141-113 3-Nitro® / Maxiban® Narasin, Nicarbazin, Roxarsone
141-121 3-Nitro® / Bio-Cox® / BMD® Bacitracin Methylene Disalicylate, Roxarsone,
Salinomycin Sodium
141-135 3-Nitro® / Bio-Cox® Roxarsone, Salinomycin Sodium
141-138 3-Nitro® / BMD® / Coban® Bacitracin Methylene Disalicylate, Monensin,
Roxarsone
141-139 3-Nitro® / Coban® Monensin, Roxarsone
141-142 3-Nitro® / Amprol® / BMD® Amprolium, Bacitracin Methylene Disalicylate,
Roxarsone
141-155 3-Nitro® / BMD® / Robenz® Bacitracin Methylene Disalicylate, Robenidine
Hydrochloride, Roxarsone
141-157 3-Nitro® / Stenorol® Halofuginone Hydrobromide, Roxarsone
141-190 3-Nitro® / BMD® / Clinacox™ Bacitracin Methylene Disalicylate, Diclazuril,
Roxarsone
141-223 Clinacox™ 3-Nitro® Diclazuril, Roxarsone
141-226 Aviax™ / Stafac® / Roxarsone Roxarsone, Semduramicin Sodium, Virginiamycin
200-080 3-Nitro® / Flavomycin® / Sacox® Bambermycins, Roxarsone, Salinomycin Sodium
200-081 3-Nitro® / BMD® / Sacox® Bacitracin Methylene Disalicylate, Roxarsone,
Salinomycin Sodium
200-086 3-Nitro® / Albac® / Sacox® Bacitracin Zinc, Roxarsone, Salinomycin Sodium
200-090 3-Nitro® / Lincomix® / Sacox® Lincomycin, Roxarsone, Salinomycin Sodium
200-091 3-Nitro® / Aureomycin® / Sacox® Chlortetracycline Calcium Complex, Roxarsone,
Salinomycin Sodium
200-094 3-Nitro® / Sacox® / Stafac® Roxarsone, Salinomycin Sodium, Virginiamycin

2.54 FDA APPROVED ANIMAL DRUG PRODUCTS January 15, 2008


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Roxarsone, cont.
200-097 3-Nitro® / Sacox® Roxarsone, Salinomycin Sodium
200-143 3-Nitro® / Baciferm® / Sacox® Bacitracin Zinc, Roxarsone, Salinomycin Sodium
200-170 3-Nitro® / Lincomix® / Nicarmix 25® Lincomycin, Nicarbazin, Roxarsone
200-172 3-Nitro® / Nicarmix 25® Nicarbazin, Roxarsone
200-206 3-Nitro® / Albac® / Deccox® Bacitracin Zinc, Decoquinate, Roxarsone
200-207 3-Nitro® / Albac® / Coyden 25® Bacitracin Zinc, Clopidol, Roxarsone
200-208 Avatec® / 3-Nitro® / Albac® Bacitracin Zinc, Lasalocid, Roxarsone
200-209 3-Nitro® / Albac® / Sacox® Bacitracin Zinc, Roxarsone, Salinomycin Sodium
200-211 3-Nitro® / Albac® / Coban® Bacitracin Zinc, Monensin, Roxarsone
200-214 3-Nitro® / Albac® / Amprol Hi-E® Amprolium, Bacitracin Zinc, Ethopabate, Roxarsone
200-215 3-Nitro® / Albac® / Bio-Cox® Bacitracin Zinc, Roxarsone, Salinomycin Sodium
200-217 3-Nitro® / Albac® / Amprol Hi-E® Amprolium, Bacitracin Zinc, Ethopabate, Roxarsone
200-259 3-Nitro® / ChlorMax™ / Sacox® Chlortetracycline, Roxarsone, Salinomycin Sodium
200-260 3-Nitro® / Bio-Cox® / ChlorMax™ Chlortetracycline, Roxarsone, Salinomycin Sodium
200-355 Pennchlor™ / Bio-Cox® / 3-Nitro® Chlortetracycline, Roxarsone, Salinomycin Sodium
Salinomycin Sodium
128-686 Bio-Cox® Type A Medicated Article Salinomycin Sodium
132-447 Bio-Cox® / Roxarsone Roxarsone, Salinomycin Sodium
134-185 3-Nitro® / Bio-Cox® / Flavomycin® Bambermycins, Roxarsone, Salinomycin Sodium
134-284 Bio-Cox® / Flavomycin® Bambermycins, Salinomycin Sodium
135-321 3-Nitro® / Bio-Cox® / BMD® Bacitracin Methylene Disalicylate, Roxarsone,
Salinomycin Sodium
135-746 Bio-Cox® / BMD® Bacitracin Methylene Disalicylate, Salinomycin
Sodium
137-536 3-Nitro® / Albac® / Bio-Cox® Bacitracin Zinc, Roxarsone, Salinomycin Sodium
137-537 Bio-Cox® / Lincomix® Lincomycin, Salinomycin Sodium
138-828 Bio-Cox® / Stafac® 10 Type A Medicated Article Salinomycin Sodium, Virginiamycin
Bio-Cox® / Stafac® 20 Type A Medicated Article

Bio-Cox® / Stafac® 50 Type A Medicated Article

Bio-Cox® / Stafac® 500 Type A Medicated Article

138-953 3-Nitro® / Bio-Cox® / Stafac® Type A Medicated Articles Roxarsone, Salinomycin Sodium, Virginiamycin
139-190 3-Nitro® / Bio-Cox® / Baciferm® Bacitracin Zinc, Roxarsone, Salinomycin Sodium
139-235 Baciferm® / Bio-Cox® Bacitracin Zinc, Salinomycin Sodium
140-448 Bio-Cox® / Terramycin® Oxytetracycline (Monoalkyl Trimethyl Ammonium
Salt), Salinomycin Sodium
140-581 3-Nitro® / Bio-Cox® / Lincomix® Lincomycin Hydrochloride, Roxarsone, Salinomycin
Sodium
140-859 Aureomycin® / Bio-Cox® Chlortetracycline Calcium Complex, Salinomycin
Sodium
140-867 Aureomycin® / Bio-Cox® / 3-Nitro® Chlortetracycline Calcium Complex, Roxarsone,
Salinomycin Sodium
141-121 3-Nitro® / Bio-Cox® / BMD® Bacitracin Methylene Disalicylate, Roxarsone,
Salinomycin Sodium
141-135 3-Nitro® / Bio-Cox® Roxarsone, Salinomycin Sodium
141-136 Bio-Cox® / BMD® Bacitracin Methylene Disalicylate, Salinomycin
Sodium
141-198 Tylan® / Bio-Cox® Salinomycin Sodium, Tylosin Phosphate
200-075 Sacox® 60 Salinomycin Sodium
200-080 3-Nitro® / Flavomycin® / Sacox® Bambermycins, Roxarsone, Salinomycin Sodium
200-081 3-Nitro® / BMD® / Sacox® Bacitracin Methylene Disalicylate, Roxarsone,
Salinomycin Sodium

January 15, 2008 FDA APPROVED ANIMAL DRUG PRODUCTS 2.55


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Salinomycin Sodium, cont.
200-082 BMD® / Sacox® Bacitracin Methylene Disalicylate, Salinomycin
Sodium
200-083 Flavomycin® / Sacox® Bambermycins, Salinomycin Sodium
200-086 3-Nitro® / Albac® / Sacox® Bacitracin Zinc, Roxarsone, Salinomycin Sodium
200-089 Baciferm® / Sacox® Bacitracin Zinc, Salinomycin Sodium
200-090 3-Nitro® / Lincomix® / Sacox® Lincomycin, Roxarsone, Salinomycin Sodium
200-091 3-Nitro® / Aureomycin® / Sacox® Chlortetracycline Calcium Complex, Roxarsone,
Salinomycin Sodium
200-092 Sacox® / Stafac® Salinomycin Sodium, Virginiamycin
200-093 Sacox® / Lincomix® Lincomycin, Salinomycin Sodium
200-094 3-Nitro® / Sacox® / Stafac® Roxarsone, Salinomycin Sodium, Virginiamycin
200-095 Aureomycin® / Sacox® Chlortetracycline Calcium Complex, Salinomycin
Sodium
200-096 Sacox® / Terramycin® Oxytetracycline, Salinomycin Sodium
200-097 3-Nitro® / Sacox® Roxarsone, Salinomycin Sodium
200-143 3-Nitro® / Baciferm® / Sacox® Bacitracin Zinc, Roxarsone, Salinomycin Sodium
200-204 Albac® / Bio-Cox® Bacitracin Zinc, Salinomycin Sodium
200-209 3-Nitro® / Albac® / Sacox® Bacitracin Zinc, Roxarsone, Salinomycin Sodium
200-210 Albac® / Sacox® Bacitracin Zinc, Salinomycin Sodium
200-215 3-Nitro® / Albac® / Bio-Cox® Bacitracin Zinc, Roxarsone, Salinomycin Sodium
200-259 3-Nitro® / ChlorMax™ / Sacox® Chlortetracycline, Roxarsone, Salinomycin Sodium
200-260 3-Nitro® / Bio-Cox® / ChlorMax™ Chlortetracycline, Roxarsone, Salinomycin Sodium
200-261 Bio-Cox® / ChlorMax™ Chlortetracycline, Salinomycin Sodium
200-262 ChlorMax™ / Sacox® Chlortetracycline, Salinomycin Sodium
200-355 Pennchlor™ / Bio-Cox® / 3-Nitro® Chlortetracycline, Roxarsone, Salinomycin Sodium
200-357 Pennchlor® / Bio-Cox® Chlortetracycline Hydrochloride, Salinomycin
Sodium
Secobarbital Sodium
128-967 Repose Euthanasia Solution Dibucaine Hydrochloride, Secobarbital Sodium
Selamectin
141-152 Revolution™ Selamectin
Selegiline Hydrochloride
141-080 Anipryl® Selegiline Hydrochloride
Selenium Disulfide
008-422 Seleen® Suspension Selenium Disulfide
111-349 SE S2 Shampoo Selenium Disulfide
115-579 Dandrex Selenium Disulfide
Semduramicin Sodium
140-940 Aviax™ Premix for Broiler Chickens Semduramicin Sodium
141-058 3-Nitro® / Aviax™ / BMD® Bacitracin Methylene Disalicylate, Roxarsone,
Semduramicin Sodium
141-065 Aviax™ / BMD® Bacitracin Methylene Disalicylate, Semduramicin
Sodium
141-066 3-Nitro® / Aviax™ Roxarsone, Semduramicin Sodium
141-114 Aviax™ / Stafac® Semduramicin Sodium, Virginiamycin
141-226 Aviax™ / Stafac® / Roxarsone Roxarsone, Semduramicin Sodium, Virginiamycin
Serum Gonadotropin
140-856 P.G. 600® Chorionic Gonadotropin, Serum Gonadotropin
Sevoflurane
141-103 SevoFlo® Sevoflurane

2.56 FDA APPROVED ANIMAL DRUG PRODUCTS January 15, 2008


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Silver Sulfadiazine
141-176 Baytril® Otic Enrofloxacin, Silver Sulfadiazine
Sodium Chloride
006-281 Intragel Gelatin, Sodium Chloride
125-961 Re-Sorb Citric Acid, Dextrose, Glycine, Potassium Citrate,
Vy'trate Potassium Phosphate, Sodium Chloride
Sodium Selenite
012-635 BO-SE Sodium Selenite, Vitamin E
L-SE
030-313 Seletoc® Minicaps and Caps Sodium Selenite, Vitamin E
030-314 Mu-Se Sodium Selenite, Vitamin E
030-315 E-SE Sodium Selenite, Vitamin E
030-316 Seletoc® Injection Sodium Selenite, Vitamin E
200-109 Velenium™ Sodium Selenite, Vitamin E
Sodium Sulfachloropyrazine Monohydrate
015-160 Sodium Sulfachloropyrazine Solution Sodium Sulfachloropyrazine Monohydrate
031-553 ESB 3 Soluble Powder Sodium Sulfachloropyrazine Monohydrate
ESB 3 Solution
Sodium Sulfate
036-361 Amp Ethopabate CTC® Sodium Sulfate Amprolium, Chlortetracycline Calcium Complex,
Ethopabate, Sodium Sulfate

Spectinomycin Dihydrochloride Pentahydrate


200-345 Lincomycin - Spectinomycin Lincomycin Hydrochloride Monohydrate,
Spectinomycin Dihydrochloride Pentahydrate
200-364 Spectogard Scour-Chek™ Spectinomycin Dihydrochloride Pentahydrate
200-380 SpecLinx-50™ Lincomycin Hydrochloride Monohydrate,
Spectinomycin Dihydrochloride Pentahydrate
200-407 Lincomycin-Spectinomycin Water Soluble Powder Lincomycin Hydrochloride, Spectinomycin
Dihydrochloride Pentahydrate
Spectinomycin Hydrochloride Pentahydrate
015-126 Spectinomycin Tablet & Injection Spectinomycin Hydrochloride Pentahydrate
033-157 Spectam® Scour Halt Spectinomycin Hydrochloride Pentahydrate
038-661 Spectam® Water Soluble Concentrate Spectinomycin Hydrochloride Pentahydrate
040-040 Spectam® Injectable Spectinomycin Hydrochloride Pentahydrate
041-629 Spectinomycin Oral Liquid Spectinomycin Hydrochloride Pentahydrate
093-483 Spectam® Injectable Spectinomycin Hydrochloride Pentahydrate
093-515 Spectam® Tablets Spectinomycin Hydrochloride Pentahydrate
200-127 PROSPEC® Injectable Spectinomycin Hydrochloride Pentahydrate
Spectinomycin Injectable
Spectinomycin Sulfate Tetrahydrate
046-109 L-S 50 Water Soluble® Powder Lincomycin Hydrochloride Monohydrate,
Spectinomycin Sulfate Tetrahydrate
141-077 Adspec® Sterile Solution Spectinomycin Sulfate Tetrahydrate
Spinosad
141-277 Comfortis™ Spinosad
Stanozolol
015-506 Winstrol-V® Tablets Stanozolol
030-844 Winstrol-V® Sterile Suspension Stanozolol
135-544 Winstrol-V® Chewable Tablets Stanozolol

January 15, 2008 FDA APPROVED ANIMAL DRUG PRODUCTS 2.57


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Streptomycin Sulfate
065-107 Entromycin Powder Bacitracin Methylene Disalicylate, Streptomycin
Sulfate
065-252 Strep-Sol Streptomycin Sulfate
065-291 Dihydrostreptomycin Sulfate Dihydrostreptomycin Sulfate, Streptomycin Sulfate
200-197 Streptomycin Oral Solution Streptomycin Sulfate
Sulfabromomethazine Sodium
011-532 Sulfabrom 2.5 g Sulfabromomethazine Sodium
Sulfachlorpyridazine
033-127 P
rinzone Bolus Sulfachlorpyridazine
Pyradan Bolus
Vetisulid® Bolus
033-318 Prinzone Injection Sulfachlorpyridazine
Pyradan Injection
Vetisulid® Injection
033-319 Vetisulid® Tablets Sulfachlorpyridazine
033-373 Prinzone Powder Sulfachlorpyridazine
Pyradan Powder
Vetisulid® Powder
040-181 Prinzone Oral Suspension Sulfachlorpyridazine
Pyradan Oral Suspension
Vetisulid® Oral Suspension
Sulfadiazine
095-614 T
ribrissen® 30 Tablets Sulfadiazine, Trimethoprim
Tribrissen® 120 Tablets
Tribrissen® 480 Tablets
Tribrissen® 960 Tablets
106-965 Tribrissen® 48% Injection Sulfadiazine, Trimethoprim
115-578 Di-Trim® Tablets Sulfadiazine, Trimethoprim
131-918 Tribrissen® 400 Oral Paste Sulfadiazine, Trimethoprim
132-486 Di-Trim® 24% Sulfadiazine, Trimethoprim
134-778 Di-Trim® 48% Injection Sulfadiazine, Trimethoprim
136-342 Di-Trim® 400 Paste Sulfadiazine, Trimethoprim
136-741 Tribrissen® 60 Oral Suspension Sulfadiazine, Trimethoprim
200-033 Uniprim™ Powder Sulfadiazine, Trimethoprim
200-244 Tucoprim® Powder Sulfadiazine, Trimethoprim
Sulfadiazine Sodium
105-093 Tribrissen® 24% Injection Sulfadiazine Sodium, Trimethoprim
141-240 ReBalance™ Antiprotozoal Oral Suspension Pyrimethamine, Sulfadiazine Sodium
Sulfadimethoxine
012-087 Bactrovet Tablets 250 mg Sulfadimethoxine
031-205 Agribon 12.5% Drinking Water Solution Sulfadimethoxine
Albon®
031-715 Agribon Boluses - 2.5 Sulfadimethoxine
Agribon Boluses - 5.0
Agribon Boluses - 15.0
Albon®
037-700 Bactrovet Oral Suspension 12.5% Sulfadimethoxine
040-209 Rofenaid® 40 Ormetoprim, Sulfadimethoxine
041-245 Agribon Injection 40% Sulfadimethoxine
Albon®
041-984 Rofenaid® / Roxarsone Ormetoprim, Roxarsone, Sulfadimethoxine

2.58 FDA APPROVED ANIMAL DRUG PRODUCTS January 15, 2008


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Sulfadimethoxine, cont.
043-785 Albon Oral Suspension 5% Sulfadimethoxine
046-285 Agribon Soluble Powder Sulfadimethoxine
Albon®
093-107 Albon® S.R. (Sustained Release) Sulfadimethoxine
098-569 Medacide-SDM Injection 10% Sulfadimethoxine
100-929 Primor® Tablets Ormetoprim, Sulfadimethoxine
125-933 Romet®-30 Ormetoprim, Sulfadimethoxine
200-030 Di-Methox 12.5% Oral Solution Sulfadimethoxine
Sulfadimethoxine 12.5% Oral Solution
200-031 Di-Methox Antibacterial Soluble Powder Sulfadimethoxine
Sulfadimethoxine Antibacterial Soluble Powder
200-038 Di-Methox Injection 40% Sulfadimethoxine
Sulfadimethoxine Injection 40%
200-165 SDM Sulfadimethoxine 12.5% Oral Solution Sulfadimethoxine
200-177 Sulfadimethoxine Injection 40% Sulfadimethoxine
200-192 Sulfadimethoxine 12.5% Oral Solution Sulfadimethoxine
200-238 Sulfasol® Soluble Powder Sulfadimethoxine
200-251 Sulforal® Sulfadimethoxine
200-258 Sulfadimethoxine Soluble Powder Sulfadimethoxine
200-376 Sulfamed-G™ Sulfadimethoxine
Sulfaethoxypyridazine
013-957 S.E.Z. Drinking Water 6.25% Sulfaethoxypyridazine
033-653 S.E.Z. Drinking Water Solution Sulfaethoxypyridazine
033-654 S.E.Z. Oblets 15 G Sulfaethoxypyridazine
033-655 S.E.Z. Intravenous Solution Sulfaethoxypyridazine
047-033 S.E.Z. C-R Oblets 15 Gm Sulfaethoxypyridazine
Sulfamerazine
033-950 Sulfamerazine In Fish Grade Sulfamerazine
100-094 PoultrySulfa™ Sulfamerazine, Sulfamethazine, Sulfaquinoxaline
Sulfamethazine
006-084 Sulmet® Drinking Water Solution Sulfamethazine
008-774 Sulmet® Solution Injectable Sulfamethazine
035-688 Aureo S-P 250® Chlortetracycline Calcium Complex, Penicillin G
Aureomix 500 Procaine, Sulfamethazine
035-805 Aureo S 700® Chlortetracycline Hydrochloride, Sulfamethazine
Aureomix S 700 Crumbles
Aureomix S 700 g
041-275 Tylan® 10 / Sulfa-G Premix Sulfamethazine, Tylosin Phosphate
Tylan® 40 / Sulfa-G Premix
041-647 Aureomix S 700-A Chlortetracycline Calcium Complex, Sulfamethazine
041-648 Aureomix S 700-D Chlortetracycline Calcium Complex, Sulfamethazine
041-649 Aureomix S 700-G Chlortetracycline Calcium Complex, Sulfamethazine
041-650 Aureomix S 700-E Chlortetracycline Calcium Complex, Sulfamethazine
041-651 Aureomix S 700-F Chlortetracycline Calcium Complex, Sulfamethazine
041-652 Aureomix S 700-C-2 Chlortetracycline Calcium Complex, Sulfamethazine
041-653 Aureomix S 700-B Chlortetracycline Calcium Complex, Sulfamethazine
041-654 Aureomix S 700-H Chlortetracycline Calcium Complex, Sulfamethazine
042-660 Purina® Pork-Plus Medicated Sulfamethazine, Tylosin Phosphate
049-729 Purina® Sulfa Sulfamethazine
049-892 Sulfamethazine Spanbolet II Sulfamethazine

January 15, 2008 FDA APPROVED ANIMAL DRUG PRODUCTS 2.59


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Sulfamethazine, cont.
055-012 Aureomycin® Sulmet Soluble Powder Chlortetracycline Bisulfate, Sulfamethazine
091-668 Chlorachel™ 250 Swine / Pficlor SP 250 Chlortetracycline Calcium Complex, Penicillin G
ChlorMax™-SP 250 Procaine, Sulfamethazine
ChlorMax™-SP 500
ChlorMax™-SP 1000
091-749 CO-OP Tylosin 40 / Sulfamethazine Sulfamethazine, Tylosin Phosphate
Tylan® 40 / Sulfa-G
093-329 HavaSpan Prolonged Release Bolus Sulfamethazine
SulfaSpan Prolonged Release Bolus
097-981 Quali-Tech Tylan®-Sulfa Premix 10 -10 Sulfamethazine, Tylosin Phosphate
Tylan® 5 / Sulfa-G
Tylan® 10 / Sulfa-G
Tylan® 20 / Sulfa-G
Tylan® 40 / Sulfa-G
098-639 Tylan® 5 / Sulfa-G Sulfamethazine, Tylosin Phosphate
Tylan® 10 / Sulfa-G
Tylan® 20 / Sulfa-G
Tylan® 40 / Sulfa-G
099-767 Purina® Tylan® 40 / Sulfamethazine Sulfamethazine, Tylosin Phosphate
100-094 PoultrySulfa™ Sulfamerazine, Sulfamethazine, Sulfaquinoxaline
101-906 Mill Co-Medicator TS-40 Premix Sulfamethazine, Tylosin Phosphate
107-002 Seeco Tylan®-Sulfa 10 Premix Med. Sulfamethazine, Tylosin Phosphate
107-957 Tylan® 20 / Sulfa-G Sulfamethazine, Tylosin Phosphate
Tylan® 40 / Sulfa-G
108-484 HFA Tylosin-10 / Sulfa Sulfamethazine, Tylosin Phosphate
109-816 Tylan® 5 / Sulfa-G Sulfamethazine, Tylosin Phosphate
Tylan® 10 / Sulfa-G

Tylan® 20 / Sulfa-G

Tylan® 40 / Sulfa-G

111-069 Tylan® 5 / Sulfa-G Sulfamethazine, Tylosin Phosphate


Tylan® 10 / Sulfa-G
Tylan® 20 / Sulfa-G
Tylan® 40 / Sulfa-G
120-614 Tylan® 5 / Sulfa-G Sulfamethazine, Tylosin Phosphate
Tylan® 10 / Sulfa-G
Tylan® 20 / Sulfa-G
Tylan® 40 / Sulfa-G
120-615 Sustain III® Bolus Sulfamethazine
122-271 Sulmet® Oblets Sulfamethazine
122-272 Sulmet® Soluble Powder Sulfamethazine
122-522 Tylan® 5 / Sulfa-G Sulfamethazine, Tylosin Phosphate
Tylan® 10 / Sulfa-G

Tylan® 20 / Sulfa-G

Tylan® 40 / Sulfa-G

124-391 Nutra-Mix Tylan®-Sulfa Premixes Sulfamethazine, Tylosin Phosphate


126-232 Calfspan™ Sulfamethazine
127-507 Tylan® 5 / Sulfa-G Sulfamethazine, Tylosin Phosphate
Tylan® 10 / Sulfa-G

Tylan® 20 / Sulfa-G

Tylan® 40 / Sulfa-G

128-411 Tylan® 5 / Sulfa Premix Sulfamethazine, Tylosin Phosphate


131-956 Tylan® / Sulfa-G Sulfamethazine, Tylosin
131-958 Tylan® / Sulfa-G Sulfamethazine, Tylosin Phosphate

2.60 FDA APPROVED ANIMAL DRUG PRODUCTS January 15, 2008


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Sulfamethazine, cont.
138-342 Tylan® 5 / Sulfa-G Premix Sulfamethazine, Tylosin Phosphate
Tylan® 10 / Sulfa-G Premix
Tylan® 20 / Sulfa-G Premix
Tylan® 40 / Sulfa-G Premix
138-934 Pennchlor SP 250 Chlortetracycline Calcium Complex, Penicillin G
Pennchlor SP 500 Procaine, Sulfamethazine
140-270 Sulfamethazine Sustained Release Bolus Sulfamethazine
140-681 Tylan® 5 / Sulfa-G Premix Sulfamethazine, Tylosin Phosphate
Tylan® 10 / Sulfa-G Premix
Tylan® 20 / Sulfa-G Premix
Tylan® 40 / Sulfa-G Premix
140-820 Tylan® 5 / Sulfa-G Premix Sulfamethazine, Tylosin Phosphate
Tylan® 10 / Sulfa-G Premix
Tylan® 20 / Sulfa-G Premix
Tylan® 40 / Sulfa-G Premix
140-908 Veta-Meth™ Sulfamethazine
140-909 Sulka-S™ Bolus Sulfamethazine
200-314 Pennchlor S™ Chlortetracycline, Sulfamethazine
200-434 SMZ-Med™ 454 Soluble Powder Sulfamethazine
Sulfamethizole
030-416 Mesulfin Tablets Methenamine Mandelate, Sulfamethizole
Sulfanitran
011-141 Unistat-2 Type A Medicated Premix Nitromide, Sulfanitran
014-250 Novastat Type A Medicated Premix Aklomide, Sulfanitran
034-537 Novastat-3 Type A Medicated Article Aklomide, Roxarsone, Sulfanitran
035-388 Novastat-W Aklomide, Sulfanitran
039-666 Unistat-3 Type A Medicated Article Nitromide, Roxarsone, Sulfanitran
Sulfaquinoxaline
006-391 S.Q. 40% Medicated Feed Sulfaquinoxaline
006-677 S.Q. 20% Solution Sulfaquinoxaline
006-707 Sulquin® 6-50 Sulfaquinoxaline
006-891 34% SUL-Q-NOX Sulfaquinoxaline
Liquid Sul-Q-Nox
007-076 Sulfa-Nox Liquid Sulfaquinoxaline
007-087 Sulfaquinoxaline Solubilized Sulfaquinoxaline
008-244 Sulfa-Nox Concentrate Sulfaquinoxaline
100-094 PoultrySulfa™ Sulfamerazine, Sulfamethazine, Sulfaquinoxaline
Sulfathiazole
039-077 CSP™ 250 Chlortetracycline Hydrochloride, Penicillin G
CSP™ 500 Procaine, Sulfathiazole
200-140 Aureozol® Chlortetracycline Hydrochloride, Penicillin G
Procaine, Sulfathiazole
200-167 Aureozol® 500 Granular Chlortetracycline Calcium Complex, Penicillin G
Procaine, Sulfathiazole
Sulfisoxazole
007-981 Soxisol Tablets Sulfisoxazole
Sulfomyxin
031-944 D
ynamyxin Injectable Sulfomyxin
Tepoxalin
141-193 Z
ubrin® Tepoxalin

January 15, 2008 FDA APPROVED ANIMAL DRUG PRODUCTS 2.61


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Testosterone Propionate
011-427 Synovex®-H Estradiol Benzoate, Testosterone Propionate
135-906 Component® E-H with Tylan® Estradiol Benzoate, Testosterone Propionate, Tylosin
Tartrate
Tetracaine
032-322 Liquisone F with Cerumene H
examethyltetracosane, Neomycin Sulfate,
Prednisolone, Tetracaine
Tetracaine Hydrochloride
010-524 Neo-Cortef® with Tetracaine Hydrocortisone Acetate, Neomycin Sulfate,
Tetracaine Hydrochloride
011-703 Neo-Delta-Cortef® with Tetracaine Ointment Neomycin Sulfate, Prednisolone Acetate, Tetracaine
Hydrochloride
015-433 Neo-Predef® with Tetracaine Ointment Isoflupredone Acetate, Myristyl-gamma-picolinium
Chloride, Neomycin Sulfate, Tetracaine
Hydrochloride
030-025 Neo-Predef® with Tetracaine Top. Ointment Isoflupredone Acetate, Neomycin Sulfate, Tetracaine
Tritop® Topical Ointment Hydrochloride
Tetracycline
065-124 Tetracycline Tetracycline
Tetracycline Hydrochloride
055-073 Panmycin® Tablets Tetracycline Hydrochloride
055-076 Albaplex® 3x Tablets Novobiocin Sodium, Tetracycline Hydrochloride
Albaplex® Tablets
065-004 Panmycin® 500 Bolus Tetracycline Hydrochloride
Panmycin® Hydrochloride
065-060 Panmycin® Aquadrops Liquid Tetracycline Hydrochloride
065-061 Tetrachel-Vet Drops Tetracycline Hydrochloride
Tetrachel-Vet Syrup
065-063 Tetracycline Capsules Tetracycline Hydrochloride
065-066 Tetrachel-Vet Tablets 100 Tetracycline Hydrochloride
065-067 Tetracycline HCl Tablets Tetracycline Hydrochloride
065-069 Tetrachel-Vet Capsules 500 Tetracycline Hydrochloride
065-090 Delta Albaplex® 3x Tablets Novobiocin Sodium, Prednisolone, Tetracycline
Delta Albaplex® Tablets Hydrochloride
065-121 Tetracycline-Vet Capsules 250 Tetracycline Hydrochloride
065-122 Tetracyn Ointment Tetracycline Hydrochloride
065-123 Tetracycline Soluble Powder Tetracycline Hydrochloride
065-140 Tet-Sol 10 Tetracycline Hydrochloride
Tet-Sol 324™
065-269 Polyotic® Soluble Powder Tetracycline Hydrochloride
065-270 Polyotic® Oblets® Tetracycline Hydrochloride
065-409 Panmycin® Capsules Tetracycline Hydrochloride
065-410 Tetra-Sal Tetracycline Hydrochloride
065-441 Polyotic® Soluble Powder Concentrate Tetracycline Hydrochloride
065-496 Tetracycline Soluble Powder Tetracycline Hydrochloride
140-578 Solu-Tet® 324 Tetracycline Hydrochloride
200-049 Tetra-Bac 324 Soluble Powder Tetracycline Hydrochloride
Tetracycline Hydrochloride Soluble Powder-324
200-136 Tetracycline HCl Powder Tetracycline Hydrochloride
Tetracycline Hydrochloride Soluble Powder-324
200-234 Tetrasol Soluble Powder Tetracycline Hydrochloride
200-374 TetraMed™ 324 HCA Tetracycline Hydrochloride

2.62 FDA APPROVED ANIMAL DRUG PRODUCTS January 15, 2008


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Tetracycline Phosphate
065-099 A
lbaplex® Capsules Novobiocin Sodium, Tetracycline Phosphate
Thenium Closylate
015-182 Canopar Tablets Thenium Closylate
101-161 Thenatol PW Tablets Piperazine Phosphate, Thenium Closylate
Thiabendazole
013-022 Thibenzole Sheep & Goat Wormer Thiabendazole
013-407 Equizole® Horse Wormer Thiabendazole
013-954 Thibenzole 20% Swine Premix Thiabendazole
014-350 O
mnizole Thiabendazole
015-123 TBZ® Cattle Wormer (Drench) Thiabendazole
015-875 TBZ 200 Medicated Feed Premix Thiabendazole
Thibenzole - 45
Thibenzole - 100
Thibenzole - 200
030-103 Thibenzole (18 mg) Thiabendazole
030-578 E-Z-EX Wormer Pellets Thiabendazole
034-114 E
quizole® Thiabendazole
035-631 Thibenzole Pig Wormer Thiabendazole
037-410 E
quizole® A Piperazine Phosphate, Thiabendazole
040-205 Purina® Horse Wormer Medicated Thiabendazole
042-633 Tresaderm Dermatologic Solution Dexamethasone, Neomycin Sulfate, Thiabendazole
042-910 E-Z-EX Wormer Mintrate Block Thiabendazole
043-141 Thibenzole 300 Medicated Thiabendazole
044-654 Equizole® Horse Wormer Pellets Thiabendazole
047-333 Equizole® A Liquid Piperazine Citrate, Thiabendazole
048-487 TBZ® Wormer Paste 50% Thiabendazole
049-461 TBZ® Wormer Paste 43% Thiabendazole
091-067 E
quivet-14 Thiabendazole, Trichlorfon
Equizole®-B
098-689 Equizole® 50% Wormer Paste Thiabendazole
Equizole® 50% Wormer Paste For Horses
Thialbarbitone Sodium
008-932 Kemithal L.A. Thialbarbitone Sodium
Thiamylal Sodium
010-809 Surital Thiamylal Sodium
039-483 Bio-Tal Thiamylal Sodium
132-028 Anestatal™ Thiamylal Sodium
Thiopental Sodium
010-346 Combuthal Powder Pentobarbital Sodium, Thiopental Sodium
046-790 Sodium Thiopental Thiopental Sodium
Thiostrepton
012-258 Panolog® Ointment Neomycin Sulfate, Nystatin, Thiostrepton,
Triamcinolone Acetonide
096-676 Panolog® Cream Neomycin Sulfate, Nystatin, Thiostrepton,
Triamcinolone Acetonide
140-810 Derma-Vet™ Ointment Neomycin Sulfate, Nystatin, Thiostrepton,
Panavet Ointment Triamcinolone Acetonide
140-847 Animax Neomycin Sulfate, Nystatin, Thiostrepton,
Triamcinolone Acetonide

January 15, 2008 FDA APPROVED ANIMAL DRUG PRODUCTS 2.63


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Thiostrepton, cont.
140-879 Derma 4 Ointment Neomycin Sulfate, Nystatin, Thiostrepton,
Triamcinolone Acetonide
141-003 Derm-Otic Ointment Neomycin Sulfate, Nystatin, Thiostrepton,
Triamcinolone Acetonide
200-245 Derma-Vet Cream Neomycin Sulfate, Nystatin, Thiostrepton,
Triamcinolone Acetonide
200-330 Animax® Cream Neomycin Sulfate, Nystatin, Thiostrepton,
Triamcinolone Acetonide
Thyroid Stimulating Hormone
011-893 Dermathycin Injectable Thyroid Stimulating Hormone
Tiamulin
134-644 Denagard® Soluble Antibiotic Tiamulin
139-472 Denagard® 5 Medicated Premix Tiamulin
Denagard® 10 Medicated Premix
Denagard® Antibiotic Premix
Tiamulin Hydrogen Fumarate
140-916 Denagard® Liquid Concentrate Tiamulin Hydrogen Fumarate
141-011 Chlortetracycline / Denagard® 10 Premixes Chlortetracycline Hydrochloride, Tiamulin Hydrogen
Fumarate
200-344 TiaGard™ Tiamulin Hydrogen Fumarate
200-356 Pennchlor™ / Denagard® Chlortetracycline Hydrochloride, Tiamulin Hydrogen
Fumarate
200-360 Tiagard™ Tiamulin Hydrogen Fumarate
Ticarcillin Disodium
055-095 Ticillin® Ticarcillin Disodium
Tiletamine Hydrochloride
106-111 Telazol® Tiletamine Hydrochloride, Zolazepam Hydrochloride
Tilmicosin Phosphate
140-929 Micotil® 300 Tilmicosin Phosphate
141-064 Pulmotil® 90 Tilmicosin Phosphate
Pulmotil® 90 Type A Medicated Article
Tioxidazole
134-645 Tiox Granules Tioxidazole
138-902 Tiox Paste Tioxidazole
Tioxidazole Paste
Tolazoline Hydrochloride
140-994 Tolazine™ Injection Tolazoline Hydrochloride
Tolnaftate
037-502 Tinavet® Cream 1% Tolnaftate
Toluene
006-691 Vermiplex Dichlorophene, Toluene
048-010 Anaplex Caps Dichlorophene, Toluene
Canine and Feline Wormer Caps
095-333 Difolin No. 1 Capsules Dichlorophene, Toluene
Difolin No. 2.5 Capsules
Difolin No. 5 Capsules
Difolin No. 25 Capsules
Difolin No. 40 Capsules
101-497 Tiny Tiger™ Worming Capsules For Cats Dichlorophene, Toluene
Worming Capsules For Puppies, Small Dogs And Cats
101-498 L.K. Worming Capsules For Dogs Dichlorophene, Toluene

2.64 FDA APPROVED ANIMAL DRUG PRODUCTS January 15, 2008


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Toluene, cont.
102-020 Tri-Plex Worm Capsules Dichlorophene, Toluene
102-942 Pulvex Multipurpose Worm Caps Dichlorophene, Toluene
103-953 Trivermicide Worm Capsules Dichlorophene, Toluene
107-189 Worm Capsules Dichlorophene, Toluene
117-688 Dichlorophene & Toluene Caps. Dichlorophene, Toluene
120-671 Pet-Worm-Caps Dichlorophene, Toluene
126-676 D & T Worm Capsules Dichlorophene, Toluene
140-850 Elite Dog & Cat Wormer Dichlorophene, Toluene
Trenbolone Acetate
138-612 F
inaplix®-H Trenbolone Acetate
Finaplix®-S
140-897 Revalor®-G Estradiol, Trenbolone Acetate
Revalor®-IS
Revalor®-S
140-992 R evalor®-200 Estradiol, Trenbolone Acetate
Revalor®-H
Revalor®-IH
141-043 Synovex® Choice Estradiol Benzoate, Trenbolone Acetate
Synovex® Plus
141-269 Revalor-XS Estradiol, Trenbolone Acetate
200-221 Component® TE-G with Tylan® Estradiol, Trenbolone Acetate, Tylosin Tartrate
Component® TE-ID with Tylan®
Component® TE-IS
Component® TE-IS with Tylan®
Component® TE-S with Tylan®
200-224 Component® T-H with Tylan® Trenbolone Acetate, Tylosin Tartrate
Component® T-S with Tylan®
200-346 Component® TE-200 Estradiol, Trenbolone Acetate, Tylosin Tartrate
Component® TE-200 with Tylan®
Component® TE-H
Component® TE-H with Tylan®
Component® TE-IH
200-367 Synovex® T40 Estradiol, Trenbolone Acetate
Synovex® T80
Synovex® T120
Triamcinolone Acetonide
012-198 Vetalog Parenteral Veterinary Triamcinolone Acetonide
012-258 Panolog® Ointment Neomycin Sulfate, Nystatin, Thiostrepton,
Triamcinolone Acetonide
013-624 Vetalog Tablets Triamcinolone Acetonide
046-146 Vetalog Cream Triamcinolone Acetonide
096-676 Panolog® Cream Neomycin Sulfate, Nystatin, Thiostrepton,
Triamcinolone Acetonide
099-388 Vetalog Oral Powder Triamcinolone Acetonide
137-694 Triamcinolone Acetonide Tablet Triamcinolone Acetonide
138-869 Triamcinolone Acetonide Suspension Triamcinolone Acetonide
140-810 Derma-Vet™ Ointment, Panavet Ointment Neomycin Sulfate, Nystatin, Thiostrepton,
Triamcinolone Acetonide
140-847 Animax Neomycin Sulfate, Nystatin, Thiostrepton,
Triamcinolone Acetonide
140-879 Derma 4 Ointment Neomycin Sulfate, Nystatin, Thiostrepton,
Triamcinolone Acetonide

January 15, 2008 FDA APPROVED ANIMAL DRUG PRODUCTS 2.65


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Triamcinolone Acetonide, cont.
141-003 Derm-Otic Ointment Neomycin Sulfate, Nystatin, Thiostrepton,
Triamcinolone Acetonide
141-210 Genesis™ Topical Spray Triamcinolone Acetonide
200-245 Derma-Vet Cream Neomycin Sulfate, Nystatin, Thiostrepton,
Triamcinolone Acetonide
200-275 Medalone Cream Triamcinolone Acetonide
200-330 Animax® Cream Neomycin Sulfate, Nystatin, Thiostrepton,
Triamcinolone Acetonide
Tricaine Methanesulfonate
042-427 Finquel Tricaine Methanesulfonate
200-226 Tricaine-S Tricaine Methanesulfonate
Trichlorfon
012-956 D
yrex Bolus Trichlorfon
Dyrex Capsules
Dyrex Granules
Dyrex Tablets
013-248 Freed No. 10 Atropine, Trichlorfon
Freed No. 25
015-154 Dyrex T.F - 200 Phenothiazine, Piperazine Dihydrochloride,
Dyrex T.F - 500 Trichlorfon
Dyrex T.F - 1000
035-650 Dyrex Powder Atropine, Trichlorfon
091-067 Equivet-14 Thiabendazole, Trichlorfon
Equizole®-B
100-402 Telmin® B Equine Wormer Mebendazole, Trichlorfon
136-740 Benzelmin® Plus Paste Oxfendazole, Trichlorfon
138-954 Telmin® B Paste Mebendazole, Trichlorfon
Trichlormethiazide
030-136 N
aquasone® Bolus Dexamethasone, Trichlormethiazide
Triflupromazine Hydrochloride
011-482 Vetame Injectable Triflupromazine Hydrochloride
Vetame Tablets
Trimeprazine Tartrate
012-437 Temaril-P® Tablets Prednisolone, Trimeprazine Tartrate
035-161 Temaril-P® Spansule Capsule No. 1 Prednisolone, Trimeprazine Tartrate
Temaril-P® Spansule Capsule No. 2
Trimethoprim
095-614 T
ribrissen® 30 Tablets Sulfadiazine, Trimethoprim
Tribrissen® 120 Tablets
Tribrissen® 480 Tablets
Tribrissen® 960 Tablets
105-093 Tribrissen® 24% Injection Sulfadiazine Sodium, Trimethoprim
106-965 Tribrissen® 48% Injection Sulfadiazine, Trimethoprim
115-578 Di-Trim® Tablets Sulfadiazine, Trimethoprim
131-918 Tribrissen® 400 Oral Paste Sulfadiazine, Trimethoprim
132-486 Di-Trim® 24% Sulfadiazine, Trimethoprim
134-778 Di-Trim® 48% Injection Sulfadiazine, Trimethoprim
136-342 Di-Trim® 400 Paste Sulfadiazine, Trimethoprim
136-741 Tribrissen® 60 Oral Suspension Sulfadiazine, Trimethoprim
200-033 Uniprim™ Powder Sulfadiazine, Trimethoprim
200-244 Tucoprim® Powder Sulfadiazine, Trimethoprim

2.66 FDA APPROVED ANIMAL DRUG PRODUCTS January 15, 2008


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Tripelennamine Hydrochloride
006-417 Recovr Injectable Tripelennamine Hydrochloride
200-162 Tripelennamine Hydrochloride Injection Tripelennamine Hydrochloride
Trypsin
031-555 Trypzyme® Aerosol Balsam Peru Oil, Castor Oil, Trypsin
039-583 Granulex Aerosol Spray Balsam Peru Oil, Castor Oil, Trypsin
040-322 Kymar Ointment Improved Chymotrypsin, Hydrocortisone Acetate, Neomycin
Palmitate, Trypsin
Tulathromycin
141-244 Draxxin™ Injectable Solution Tulathromycin
Tylosin
012-965 Tylan® Injection 50 mg Tylosin
Tylan® Injection 200 mg
013-388 Hygromix-Tylan® Premix Hygromycin B, Tylosin
131-956 Tylan® / Sulfa-G Sulfamethazine, Tylosin
138-955 Tylosin® Injection Tylosin
141-149 Deccox® / Rumensin® / Tylan® Decoquinate, Monensin, Tylosin
Tylosin Phosphate
012-491 Tylan® 40 CAL Type A Medicated Article Tylosin Phosphate
Tylan® 100 CAL Type A Medicated Article
012-548 Tylosin® / Hygromix Hygromycin B, Tylosin Phosphate
013-162 Tylan® Premix No.10 Tylosin Phosphate
015-166 Tylan® 100 Premix Tylosin Phosphate
041-275 Tylan® 10 / Sulfa-G Premix Sulfamethazine, Tylosin Phosphate
Tylan® 40 / Sulfa-G Premix
042-660 Purina® Pork-Plus Medicated Sulfamethazine, Tylosin Phosphate
043-387 Purina® Hog Plus II Tylosin Phosphate
046-415 CO-OP Tylan® 10 Mix Tylosin Phosphate
Tylosin® 5 Type A Medicated Article
Tylosin® 10 Type A Medicated Article
Tylosin® 20 Type A Medicated Article
Tylosin® 40 Type A Medicated Article
049-890 Norco T-2 Pre-Pak Tylosin Phosphate
091-582 Gilt Edge Tylan® Mix Tylosin Phosphate
091-749 CO-OP Tylosin 40 / Sulfamethazine Sulfamethazine, Tylosin Phosphate
Tylan® 40 / Sulfa-G
095-551 Tylan® 5 Premix Tylosin Phosphate
095-953 Moormaboost TY 4000 Medicated Tylosin Phosphate
096-161 Hy-Con Tylan® Premix Tylosin Phosphate
097-980 Quali-Tech Tylan®-10 Premix T
ylosin Phosphate
097-981 Quali-Tech Tylan®-Sulfa Premix 10 -10 Sulfamethazine, Tylosin Phosphate
Tylan® 5 / Sulfa-G
Tylan® 10 / Sulfa-G
Tylan® 20 / Sulfa-G
Tylan® 40 / Sulfa-G
098-429 Medic-Meal-T Premix Tylosin Phosphate
098-431 Tylan® 10 Premix Tylosin Phosphate
098-639 Tylan® 5 / Sulfa-G Sulfamethazine, Tylosin Phosphate
Tylan® 10 / Sulfa-G
Tylan® 20 / Sulfa-G
Tylan® 40 / Sulfa-G
099-468 Waynextra For Swine Tylosin Phosphate

January 15, 2008 FDA APPROVED ANIMAL DRUG PRODUCTS 2.67


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Tylosin Phosphate, cont.
099-767 Purina® Tylan® 40 / Sulfamethazine Sulfamethazine, Tylosin Phosphate
100-128 Supersweet Medipak Tylan® 10 Tylosin Phosphate
100-352 Seeco Inc T-10 Premix Tylosin Phosphate
100-556 Vigorena Feeds Hy-Ty Premix Tylosin Phosphate
100-991 McNess Custom Premix L200 Tylosin Phosphate
101-905 Mill Co-Medicator TY-4 Tylosin Phosphate
Mill Co-Medicator TY-10
101-906 Mill Co-Medicator TS-40 Premix Sulfamethazine, Tylosin Phosphate
103-089 Tylan® 5 Tylosin Phosphate
Tylan® 10

Tylan® 20

Tylan® 40

104-646 Rumensin® / Tylan® Monensin Sodium, Tylosin Phosphate


106-507 Tylan® 5 Tylosin Phosphate
Tylan® 10
Tylan® 20
Tylan® 40
107-002 Seeco Tylan®-Sulfa 10 Premix Med. Sulfamethazine, Tylosin Phosphate
107-957 Tylan® 20 / Sulfa-G Sulfamethazine, Tylosin Phosphate
Tylan® 40 / Sulfa-G
108-484 HFA Tylosin-10 / Sulfa Sulfamethazine, Tylosin Phosphate
109-816 Tylan® 5 / Sulfa-G Sulfamethazine, Tylosin Phosphate
Tylan® 10 / Sulfa-G

Tylan® 20 / Sulfa-G

Tylan® 40 / Sulfa-G

110-044 Peavy Pro-Tone Plus Pak GF T-1 Tylosin Phosphate


110-045 Good-Life Tylan® 10 Premix Tylosin Phosphate
110-047 Banminth® Tylan® Pyrantel Tartrate, Tylosin Phosphate
111-069 Tylan® 5 / Sulfa-G SulfamethazineTylosin Phosphate
Tylan® 10 / Sulfa-G

Tylan® 20 / Sulfa-G

Tylan® 40 / Sulfa-G

120-614 Tylan® 5 / Sulfa-G Sulfamethazine, Tylosin Phosphate


Tylan® 10 / Sulfa-G
Tylan® 20 / Sulfa-G
Tylan® 40 / Sulfa-G
121-147 Nutra-Mix Tylan® - 5 Tylosin Phosphate
Nutra-Mix Tylan® - 10
Nutra-Mix Tylan® - 20
Nutra-Mix Tylan® - 40
122-522 Tylan® 5 / Sulfa-G Sulfamethazine, Tylosin Phosphate
Tylan® 10 / Sulfa-G
Tylan® 20 / Sulfa-G
Tylan® 40 / Sulfa-G
124-391 Nutra-Mix Tylan®-Sulfa Premixes Sulfamethazine, Tylosin Phosphate
127-195 Tylan® 10 Tylosin Phosphate
Tylan® 40
127-507 Tylan® 5 / Sulfa-G Sulfamethazine, Tylosin Phosphate
Tylan® 10 / Sulfa-G
Tylan® 20 / Sulfa-G
Tylan® 40 / Sulfa-G
128-411 Tylan® 5 / Sulfa Premix Sulfamethazine, Tylosin Phosphate

2.68 FDA APPROVED ANIMAL DRUG PRODUCTS January 15, 2008


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Tylosin Phosphate, cont.
131-537 Baby Pig Premix Tylosin Phosphate
Gossett G-F Swine Premixes
131-957 Tylan® 5 Tylosin Phosphate
Tylan® 10
Tylan® 20
Tylan® 40
131-958 Tylan® / Sulfa-G Sulfamethazine, Tylosin Phosphate
133-833 Tylan® 10 Premix Tylosin Phosphate
138-187 Tylan® 40 Premix Tylosin Phosphate
Tylan® 10 Premix

Tylan® 100 Premix

138-342 Tylan® 5 / Sulfa-G Premix Sulfamethazine, Tylosin Phosphate


Tylan® 10 / Sulfa-G Premix
Tylan® 20 / Sulfa-G Premix
Tylan® 40 / Sulfa-G Premix
138-792 MGA® 100 / Rumensin® / Tylan® Melengestrol Acetate, Monensin Sodium, Tylosin
MGA® 200 / Rumensin® / Tylan® Phosphate
138-870 MGA® (liquid) / Rumensin® / Tylan® Melengestrol Acetate, Monensin Sodium, Tylosin
MGA® 100-200 Premix / MGA® 500 Liquid Premix / Phosphate
Rumensin® / Tylan®
138-904 Bovatec® / MGA® 100 / Tylan® Lasalocid, Melengestrol Acetate, Tylosin Phosphate
Bovatec® / MGA® 100-200 Premix / Tylan®
Bovatec® / MGA® 200 / Tylan®
Bovatec® / MGA® 500 Liquid Premix / Tylan®
138-992 Bovatec® / MGA® (liquid) / Tylan® Lasalocid, Melengestrol Acetate, Tylosin Phosphate
138-995 MGA® 100 / Tylan® Melengestrol Acetate, Tylosin Phosphate
MGA® 200 / Tylan®
139-192 MGA® 500 (liquid)-Tylan® Melengestrol Acetate, Tylosin Phosphate
140-680 Tylan® 5 Premix Tylosin Phosphate
Tylan® 10 Premix

Tylan® 20 Premix

Tylan® 40 Premix

140-681 Tylan® 5 / Sulfa-G Premix Sulfamethazine, Tylosin Phosphate


Tylan® 10 / Sulfa-G Premix
Tylan® 20 / Sulfa-G Premix
Tylan® 40 / Sulfa-G Premix
140-820 Tylan® 5 / Sulfa-G Premix Sulfamethazine, Tylosin Phosphate
Tylan® 10 / Sulfa-G Premix
Tylan® 20 / Sulfa-G Premix
Tylan® 40 / Sulfa-G Premix
140-955 Coban® / Flavomycin® Monensin, Tylosin Phosphate
141-164 Coban® / Tylan® Monensin, Tylosin Phosphate
141-170 Monteban® / Tylan® Narasin, Tylosin Phosphate
141-172 Paylean® / Tylan® Ractopamine Hydrochloride, Tylosin Phosphate
141-198 Tylan® / Bio-Cox® Salinomycin Sodium, Tylosin Phosphate
141-224 Optaflexx™ / Rumensin® / Tylan® Monensin Sodium, Ractopamine Hydrochloride,
Tylosin Phosphate
141-233 Optaflexx™ / Rumensin® / Tylan® / MGA® Melengestrol Acetate, Monensin Sodium,
Ractopamine Hydrochloride, Tylosin Phosphate
200-375 HeifermaX™ 500 / Rumensin® / Tylan® Melengestrol Acetate, Monensin Sodium, Tylosin
Phosphate
200-424 HeifermaX™ / Optaflexx® / Rumensin® / Tylan® Melengestrol Acetate, Monensin Sodium,
Ractopamine Hydrochloride, Tylosin Phosphate

January 15, 2008 FDA APPROVED ANIMAL DRUG PRODUCTS 2.69


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Tylosin Phosphate, cont.
200-427 HeifermaX™ 500 Liquid Premix / Tylan® Melengestrol Acetate, Tylosin Phosphate
200-430 HeifermaX™ 500 Liquid Premix / Bovatec® / Tylan® Lasalocid, Melengestrol Acetate, Tylosin Phosphate
Tylosin Tartrate
013-076 Tylan® Soluble Tylosin Tartrate
110-315 Component® E-C with Tylan® Estradiol Benzoate, Progesterone, Tylosin Tartrate
Component® E-S with Tylan®
135-906 Component® E-H with Tylan® Estradiol Benzoate, Testosterone Propionate, Tylosin
Tartrate
200-221 Component® TE-G with Tylan® Estradiol, Trenbolone Acetate, Tylosin Tartrate
Component® TE-ID with Tylan®
Component® TE-IS
Component® TE-IS with Tylan®
Component® TE-S with Tylan®
200-224 Component® T-H with Tylan® Trenbolone Acetate, Tylosin Tartrate
Component® T-S with Tylan®
200-346 Component® TE-200 Estradiol, Trenbolone Acetate, Tylosin Tartrate
Component® TE-200 with Tylan®
Component® TE-H
Component® TE-H with Tylan®
Component® TE-IH
Virginiamycin
091-467 Stafac® 500 Virginiamycin
091-513 Stafac® Virginiamycin
120-724 3-Nitro® / Stafac® / Coban® Monensin Sodium, Roxarsone, Virginiamycin
122-481 Coban® / Stafac® Monensin Sodium, Virginiamycin
122-608 Avatec® / Stafac® Lasalocid, Virginiamycin
122-822 Amprol HI-E® / Stafac® Amprolium, Ethopabate, Virginiamycin
133-333 Stafac® 10 Virginiamycin
133-334 Virginiamycin Type A Medicated Article Virginiamycin
133-335 Stafac® Swine Pak 10 g Virginiamycin
138-828 Bio-Cox® / Stafac® 10 Type A Medicated Article Salinomycin Sodium, Virginiamycin
Bio-Cox® / Stafac® 20 Type A Medicated Article

Bio-Cox® / Stafac® 50 Type A Medicated Article

Bio-Cox® / Stafac® 500 Type A Medicated Article

138-953 3-Nitro® / Bio-Cox® / Stafac® Type A Medicated Articles Roxarsone, Salinomycin Sodium, Virginiamycin
139-473 Stafac® / Stenorol® Halofuginone Hydrobromide, Virginiamycin
140-998 V-Max™ Virginiamycin
V-Max™ M
141-090 Clinacox™ / Stafac® Diclazuril, Virginiamycin
141-110 Coban® / Stafac® Monensin, Virginiamycin
141-114 Aviax™ / Stafac® Semduramicin Sodium, Virginiamycin
141-150 Avatec® / Stafac® Lasalocid, Virginiamycin
141-226 Aviax™ / Stafac® / Roxarsone Roxarsone, Semduramicin Sodium, Virginiamycin
200-092 Sacox® / Stafac® Salinomycin Sodium, Virginiamycin
200-094 3-Nitro® / Sacox® / Stafac® Roxarsone, Salinomycin Sodium, Virginiamycin
Vitamin E
012-635 BO-SE Sodium Selenite, Vitamin E
L-SE
030-313 Seletoc® Minicaps and Caps Sodium Selenite, Vitamin E
030-314 Mu-Se Sodium Selenite, Vitamin E
030-315 E-SE Sodium Selenite, Vitamin E

2.70 FDA APPROVED ANIMAL DRUG PRODUCTS January 15, 2008


Section 2.0

Active Ingredients

Ingredient
NADA Trade Name Ingredients
Vitamin E, cont.
030-316 Seletoc® Injection Sodium Selenite, Vitamin E
200-109 Velenium™ Sodium Selenite, Vitamin E
Xylazine Hydrochloride
047-955 Rompun® Injectable (20 mg) Xylazine Hydrochloride
047-956 Rompun® Injectable (100 mg) Xylazine Hydrochloride
139-236 Anased® Xylazine Hydrochloride
Anased® Injectable
Cervizine 300 Injectable
140-442 Xylazine HCl Injection Xylazine Hydrochloride
200-088 Sedazine™ Xylazine Hydrochloride
200-139 Chanazine® Xylazine Hydrochloride
200-184 Chanazine® Xylazine Hydrochloride
Yohimbine Hydrochloride
140-866 Yobine® Injectable Solution Yohimbine Hydrochloride
Yobine® Injection
140-874 Antagonil Yohimbine Hydrochloride
Zeranol
038-233 Ralgro® Implants Zeranol
Ralgro® Magnum
141-192 Ralgro® L. A. Zeranol
Zilpaterol
141-258 Zilmax® Zilpaterol
Zinc Gluconate
141-217 Neutersol® Injectable Solution Zinc Gluconate
Zoalene
011-116 Zoamix® Type A Medicated Article Zoalene
013-747 Zoalene 90 Medicated Coccidiostat Zoalene
038-241 Erythro® (High Lev) / Zoalene / Arsanilic Acid Arsanilic Acid, Erythromycin Thiocyanate, Zoalene
038-879 Carb-O-Sep® / Zoamix® Carbarsone, Zoalene
048-954 Lincomix® / Zoamix® Lincomycin Hydrochloride Monohydrate, Zoalene
101-628 3-Nitro® / Flavomycin® / Zoalene Bambermycins, Roxarsone, Zoalene
101-629 Flavomycin® / Zoalene Bambermycins, Zoalene
141-085 BMD® / Zoamix® Bacitracin Methylene Disalicylate, Zoalene
Zolazepam Hydrochloride
106-111 Telazol® Tiletamine Hydrochloride, Zolazepam Hydrochloride

January 15, 2008 FDA APPROVED ANIMAL DRUG PRODUCTS 2.71

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