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Section 2.0 - Active Ingredients
ApplicationNumber
Active Ingredients Trade Name
005-236 2-Mercaptobenzothiazole Sulfodene® Medication for Dogs
015-030 Acepromazine Maleate PromAce® Injectable
032-702 Acepromazine Maleate PromAce® Tablets
117-531 Acepromazine Maleate Acepromazine Maleate Injection
117-532 Acepromazine Maleate PromAce®
200-319 Acepromazine Maleate Acepromazine Maleate Injection
200-361 Acepromazine Maleate Acepromazine Maleate Injection
011-582 Acetazolamide Sodium Vetamox Soluble Powder
011-700 Acetylsalicylic Acid Cortaba® Tablets
141-406 Afoxolaner NexGard®
110-048 Albendazole Valbazen®
128-070 Albendazole Valbazen®
140-934 Albendazole Valbazen®
141-180 Albuterol Sulfate Torpex™
141-342 Alfaxalone Alfaxan® Multidose
131-310 Altrenogest Regu-Mate®
141-222 Altrenogest Matrix®
200-481 Altrenogest OvaMed®
200-579 Altrenogest ChronoMate™
200-620 Altrenogest Altren®
200-621 Altrenogest SwineMate®
127-892 Amikacin Sulfate Amiglyde-V
200-178 Amikacin Sulfate Amikacin Sulfate Injection
200-181 Amikacin Sulfate AmiMax™ E Solution
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:2
ApplicationNumber
Active Ingredients Trade Name
043-078 Aminopentamide Hydrogen Sulfate Centrine Oral Tablets
043-079 Aminopentamide Hydrogen Sulfate Centrine Injectable
092-116 Aminopentamide Hydrogen Sulfate Ketaset® Plus
011-877 Aminopropazine Fumarate Jenotone Tablets
013-181 Aminopropazine Fumarate Jenomycin Tablets
034-477 Aminopropazine Fumarate Jenotone Solution
120-299 Amitraz Mitaban® Liquid Concentrate
009-339 Ammonium Chloride Carafen Cough Syrup, Carafen Cough Tablets
055-078 Amoxicillin Trihydrate Amoxi-Tabs
055-080 Amoxicillin Trihydrate Amoxi-Doser
055-081 Amoxicillin Trihydrate Amoxi-Tabs®
055-085 Amoxicillin Trihydrate Amoxi-Drop® Oral Suspension
055-087 Amoxicillin Trihydrate Amoxi-Bol
055-088 Amoxicillin Trihydrate Amoxi-Sol
055-089 Amoxicillin Trihydrate Amoxi-Inject (Cattle)
055-091 Amoxicillin Trihydrate Amoxi-Inject (Dogs and Cats)
055-099 Amoxicillin Trihydrate CLAVAMOX® CHEWABLE Tablets,CLAVAMOX® tablets
055-100 Amoxicillin Trihydrate Amoxi-Mast
055-101 Amoxicillin Trihydrate Clavamox® Drops
065-492 Amoxicillin Trihydrate Biomox, Robamox®-V Tablets
065-495 Amoxicillin Trihydrate Biomox®, Robamox®-V
141-004 Amoxicillin Trihydrate Robamox®-V
141-005 Amoxicillin Trihydrate Robamox®-V Tablets
200-592 Amoxicillin Trihydrate Clavacillin®
200-604 Amoxicillin Trihydrate Amoxicillin and Clavulanate Potassium for OralSuspension
200-702 Amoxicillin Trihydrate Amoxicillin and Clavulanate Potassium Tablets
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:3
ApplicationNumber
Active Ingredients Trade Name
200-709 Amoxicillin Trihydrate Amoxicillin and Clavulanate Potassium for OralSuspension
043-784 Amphomycin Calcium Kanfosone Ointment
047-997 Amphomycin Calcium Amphoderm Ointment
055-013 Ampicillin Anhydrous Omnipen 250 mg
055-084 Ampicillin Sodium Amp-Equine
200-335 Ampicillin Sodium Ampicillin Sodium
055-030 Ampicillin Trihydrate Polyflex®
055-042 Ampicillin Trihydrate Ampi-Tab
055-064 Ampicillin Trihydrate Princillin Injection
055-066 Ampicillin Trihydrate Princillin Injection
055-071 Ampicillin Trihydrate Princillin Injection 200 mg
055-074 Ampicillin Trihydrate Ampi-Bol
055-079 Ampicillin Trihydrate Ampi-Ject
200-180 Ampicillin Trihydrate Ampicillin Trihydrate
012-350 Amprolium Amprol® 25% Type A Medicated Article, Corid®Type A Medicated Article
013-149 Amprolium Amprovine 9.6% Solution, CORID® 9.6% OralSolution
013-461 Amprolium Amprol Hi-E, Amprol Plus
013-663 Amprolium Cocciprol™
033-165 Amprolium AMPROL® 128, Corid 20% Soluble Powder
036-304 Amprolium Amprol HI-E® Plus
036-361 Amprolium Amprol Plus® and Aureomycin®
095-543 Amprolium Amprol HI-E® & Bambermycins, Amprol HI-E® / Flavomycin®
114-794 Amprolium Baciferm® / Amprol HI-E® Premix
130-185 Amprolium Flavomycin® and Amprol®/ Amprol 25%® andFlavomycin®
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:4
ApplicationNumber
Active Ingredients Trade Name
141-156 Amprolium Amprol® / BMD®
141-469 Amprolium Stafac® and AMPROL®
200-205 Amprolium Albac® / Amprol Hi-E®
200-389 Amprolium Amprolium 9.6% Oral Solution
200-463 Amprolium Amprolium-P 9.6% Oral Solution
200-464 Amprolium AMPROMED™ For Cattle
200-482 Amprolium AmproMed™ for Calves
200-488 Amprolium Ampromed™ P for Poultry
200-496 Amprolium AmproMed™ P for Poultry
200-514 Amprolium Boviprol™ 9.6% Oral Solution
200-630 Amprolium CocciAid®
106-964 Apramycin Sulfate Apralan™
126-050 Apramycin Sulfate Apralan® 75
006-623 Arsenamide Sodium Caparsolate Sodium
141-033 Atipamezole Hydrochloride Antisedan®
200-624 Atipamezole Hydrochloride REVERTIDINE™
013-248 Atropine Freed No. 10, Freed No. 25
035-650 Atropine Dyrex Powder
042-548 Attapulgite Amforol® Suspension
042-841 Attapulgite Amforol® Veterinary Oral Tablets
141-438 Avilamycin Kavault™
141-439 Avilamycin Inteprity™
141-465 Avilamycin Inteprity™ and Coban™
141-466 Avilamycin Inteprity™ and Maxiban™
141-467 Avilamycin Inteprity™ and Monteban™
141-495 Avilamycin Inteprity™ and Bio-Cox®
115-732 Azaperone Stresnil Injection
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:5
ApplicationNumber
Active Ingredients Trade Name
141-529 Bacitracin Pennitracin MD® and Maxiban™
141-540 Bacitracin Pennitracin MD® and Coban™
200-705 Bacitracin ZoaShield™ and BMD®
036-304 Bacitracin methylene disalicylate Amprol HI-E® Plus
046-592 Bacitracin methylene disalicylate BMD 30 Granular A, BMD 50 Granular A,BMD® 30, BMD® 50, BMD® 60
049-463 Bacitracin methylene disalicylate Coban™ plus BMD®
065-107 Bacitracin methylene disalicylate Entromycin Powder
065-280 Bacitracin methylene disalicylate Soluble Fortracin Concentrate
065-470 Bacitracin methylene disalicylate BMD® Soluble
097-085 Bacitracin methylene disalicylate Bac MD / Robenz®
098-378 Bacitracin methylene disalicylate Nicarbazin / Bacitracin Premix
099-150 Bacitracin methylene disalicylate BMD® and Coyden 25®
107-996 Bacitracin methylene disalicylate Avatec® / Fortracin Premix
135-746 Bacitracin methylene disalicylate Bio-Cox® / BMD®
138-456 Bacitracin methylene disalicylate Coban® / BMD®
140-584 Bacitracin methylene disalicylate BMD / Stenorol®
140-853 Bacitracin methylene disalicylate BMD® / Monteban®
140-919 Bacitracin methylene disalicylate BMD® / Stenorol®
140-926 Bacitracin methylene disalicylate BMD® / Maxiban®
140-937 Bacitracin methylene disalicylate BMD® / Coban®
141-059 Bacitracin methylene disalicylate BMD® and ChlorMax®
141-065 Bacitracin methylene disalicylate Aviax™ / BMD®
141-085 Bacitracin methylene disalicylate BMD® / Zoamix®
141-097 Bacitracin methylene disalicylate BMD® / Ivomec® Premix for Swine
141-102 Bacitracin methylene disalicylate BMD® / Deccox®
141-124 Bacitracin methylene disalicylate BMD® / Maxiban®
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:6
ApplicationNumber
Active Ingredients Trade Name
141-130 Bacitracin methylene disalicylate BMD® and Zoamix®
141-136 Bacitracin methylene disalicylate Bio-Cox® / BMD®
141-137 Bacitracin methylene disalicylate Pennitracin MD 50G®
141-140 Bacitracin methylene disalicylate BMD® / Coban®
141-144 Bacitracin methylene disalicylate BMD® / Safe-Guard®
141-153 Bacitracin methylene disalicylate Clinacox™ and BMD®
141-154 Bacitracin methylene disalicylate BMD® / Robenz®
141-156 Bacitracin methylene disalicylate Amprol® / BMD®
141-179 Bacitracin methylene disalicylate Avatec® / BMD®
141-194 Bacitracin methylene disalicylate Clinacox™ and BMD®
141-279 Bacitracin methylene disalicylate Nicarb® 25% plus BMD®
200-082 Bacitracin methylene disalicylate BMD® / Sacox®
200-164 Bacitracin methylene disalicylate BMD® / Nicarmix 25®
200-242 Bacitracin methylene disalicylate BMD®-25, -30, -40, -50, -60, or -75 /Aureomycin® -50, -70, -80, -90 or -100
200-358 Bacitracin methylene disalicylate BMD® Pennchlor®
045-348 Bacitracin Zinc Albac® / Deccox®, Broiler Finisher Medicated
046-920 Bacitracin Zinc Baciferm® - 10, Baciferm® - 25, Baciferm® - 40,Baciferm® - 50
047-933 Bacitracin Zinc Coban™ plus Baciferm®
049-934 Bacitracin Zinc Coyden 25® with Bacitracin Zinc
065-015 Bacitracin Zinc Bacitracin-Neomycin-Polymyxin withHydrocortisone Acetate Ophthalmic Ointment,Vetropolycin HC Ophthalmic Ointment
065-016 Bacitracin Zinc Bac-Neo-Poly Ophthalmic Ointment, VetropolycinOphthalmic Ointment
065-114 Bacitracin Zinc Mycitracin® Sterile Ophthalmic Ointment
065-313 Bacitracin Zinc Baciferm® Soluble 50
065-476 Bacitracin Zinc Cortisporin Veterinary Ophthalmic Ointment
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:7
ApplicationNumber
Active Ingredients Trade Name
065-485 Bacitracin Zinc Neosporin Ophthalmic Ointment
096-933 Bacitracin Zinc Robenz® Plus Zn Bacitracin
098-452 Bacitracin Zinc Albac® 50 Type A Medicated Article
114-794 Bacitracin Zinc Baciferm® / Amprol HI-E® Premix
134-830 Bacitracin Zinc Albac® / Coban®
139-235 Bacitracin Zinc Baciferm® / Bio-Cox®
140-865 Bacitracin Zinc Baciferm® / Albac®, Baciferm® / Monteban®
141-083 Bacitracin Zinc Avatec® / Baciferm®
141-109 Bacitracin Zinc Avatec® / Baciferm®
141-146 Bacitracin Zinc Nicarb® / Baciferm®
141-181 Bacitracin Zinc Avatec® / Albac®
200-089 Bacitracin Zinc Baciferm® / Sacox®
200-204 Bacitracin Zinc Albac® / Bio-Cox®
200-205 Bacitracin Zinc Albac® / Amprol Hi-E®
200-210 Bacitracin Zinc Albac® / Sacox®
200-212 Bacitracin Zinc Albac® / Robenz®
200-213 Bacitracin Zinc Albac® / Deccox®
200-218 Bacitracin Zinc Albac® / Coyden 25®
200-223 Bacitracin Zinc Albac® 50 Type A Medicated Article
200-478 Bacitracin Zinc Albac® 50 plus Nicarb®
200-553 Bacitracin Zinc Neomycin and Polymyxin B Sulfates, andBacitracin Zinc Ophthalmic Ointment
031-555 Balsam Peru Oil Trypzyme® Aerosol
039-583 Balsam Peru Oil Granulex® V
044-759 Bambermycins Flavomycin® 4
095-543 Bambermycins Amprol HI-E® & Bambermycins, Amprol HI-E® / Flavomycin®
098-340 Bambermycins Flavomycin® / Monensin
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:8
ApplicationNumber
Active Ingredients Trade Name
101-629 Bambermycins Flavomycin® / Zoalene
130-185 Bambermycins Flavomycin® and Amprol®/ Amprol 25%® andFlavomycin®
132-448 Bambermycins Flavomycin®
134-284 Bambermycins Bio-Cox® / Flavomycin®
137-483 Bambermycins Flavomycin® / Stenorol®
140-339 Bambermycins Nicarbazin (NICARB®) plus Bambermycins(FLAVOMYCIN®)
140-845 Bambermycins Flavomycin® / Monteban®
140-918 Bambermycins Flavomycin® / Stenorol®
140-942 Bambermycins Flavomycin® / Maxiban®
140-955 Bambermycins Coban® / Flavomycin®
141-034 Bambermycins GAINPRO® 10
141-129 Bambermycins Avatec® / Flavomycin®
141-158 Bambermycins Clinacox™ and Flavomycin®
141-195 Bambermycins Clinacox™ and Flavomycin®
141-419 Bambermycins Coyden® and Flavomycin®
200-083 Bambermycins Flavomycin® / Sacox®
141-511 Bc2371 rDNA construct Bc2371 rDNA construct in R69 New Zealandwhite rabbits
141-294 Bc6 recombinant deoxyribonucleic acidconstruct
Bc6 rDNA construct in GTC 155-92 Goats
141-538 Benazepril hydrochloride Cardalis™
034-010 Betamethasone Acetate Betavet Soluspan Suspension
034-267 Betamethasone Acetate Gentocin® Durafilm®
141-418 Betamethasone Acetate BetaVet®
141-437 Betamethasone Acetate Osurnia™
049-185 Betamethasone Dipropionate Betasone Aqueous Suspension
034-010 Betamethasone Sodium Phosphate Betavet Soluspan Suspension
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:9
ApplicationNumber
Active Ingredients Trade Name
049-185 Betamethasone Sodium Phosphate Betasone Aqueous Suspension
141-418 Betamethasone Sodium Phosphate BetaVet®
046-821 Betamethasone Valerate Gentocin® Otic Solution
113-231 Betamethasone Valerate Topagen® Ointment
132-338 Betamethasone Valerate Gentocin® Topical Spray
140-896 Betamethasone Valerate Otomax®
200-183 Betamethasone Valerate VET BETA-GEN®
200-188 Betamethasone Valerate Betagen™ Topical Spray
200-229 Betamethasone Valerate Tri-Otic® Ointment
200-283 Betamethasone Valerate Vetro-Max®
200-287 Betamethasone Valerate GBC Ointment™
200-388 Betamethasone Valerate GB Topical Spray
200-415 Betamethasone Valerate Gentamicin Sulfate Topical Spray
200-416 Betamethasone Valerate Gentamicin Topical Spray
042-548 Bismuth Subcarbonate Amforol® Suspension
042-841 Bismuth Subcarbonate Amforol® Veterinary Oral Tablets
034-705 Boldenone Undecylenate Equipoise®
140-872 Bovine Somatotropin (Sometribove Zinc) Posilac™
035-016 Bunamidine Hydrochloride Scolaban 400
141-461 Bupivacaine Nocita™
141-434 Buprenorphine Simbadol™
141-547 Buprenorphine Zorbium™
130-872 Butacaine Sulfate Nitrofurazone Anesthetic Dress.
104-184 Butamisole Hydrochloride Styquin
132-533 Butamisole Hydrochloride Styquin Parenteral 1.1%
102-990 Butorphanol Tartrate Torbutrol® Injection
103-390 Butorphanol Tartrate Torbutrol® Tablets
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:10
ApplicationNumber
Active Ingredients Trade Name
135-780 Butorphanol Tartrate Torbugesic®
141-047 Butorphanol Tartrate Torbugesic-SA®
200-239 Butorphanol Tartrate Dolorex®
200-322 Butorphanol Tartrate Butorphanol Tartrate Injection
200-332 Butorphanol Tartrate Butorphic™ Injection
200-408 Butorphanol Tartrate Butorphanol Tartrate Injection
094-642 Cambendazole Camvet Suspension Horse Wormer
096-506 Cambendazole Camvet Horse Wormer Pellets
096-731 Cambendazole Camvet Horse Wormer Paste 45%
141-457 Capromorelin ENTYCE™
141-536 Capromorelin Elura™
009-339 Caramiphen Edisylate Carafen Cough Syrup, Carafen Cough Tablets
041-061 Carbadox Mecadox® Premix 10
092-955 Carbadox Banminth® / Mecadox®
141-211 Carbadox Mecadox® and Terramycin®
032-946 Carbomycin MAGNA-TERRAMYCIN® Soluble Powder
141-362 Carbon Dioxide, USP None (Med Gas)
141-371 Carbon Dioxide, USP None (Med Gas)
141-385 Carbon Dioxide, USP None (Med Gas)
141-390 Carbon Dioxide, USP None (Med Gas)
141-415 Carbon Dioxide, USP None (Med Gas)
139-879 Carnidazole Carnidazole, Spartrix®
141-053 Carprofen Rimadyl® Caplets
141-111 Carprofen Rimadyl® Chewable Tablets
141-199 Carprofen Rimadyl® Sterile Injectable Solution
200-366 Carprofen Carprofen Caplets, Novox® Caplets
200-397 Carprofen Vetprofen™
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:11
ApplicationNumber
Active Ingredients Trade Name
200-490 Carprofen Carprofen
200-498 Carprofen Carprieve® Caplets
200-520 Carprofen Carprieve® Injection
200-522 Carprofen Carprofen Sterile Injectable Solution
200-555 Carprofen quellin®
200-575 Carprofen Carprofen Chewable Tablets
200-578 Carprofen Carprofen Flavored Tablets
200-593 Carprofen Carprofen Injection
200-595 Carprofen Carprieve® Chewable Tablets
200-681 Carprofen Carprofen Tablets
200-687 Carprofen Carprofen Chewable Tablets
200-703 Carprofen Carprofen Tablets
200-706 Carprofen CARPROFEN Chewable Tablets
031-555 Castor Oil Trypzyme® Aerosol
039-583 Castor Oil Granulex® V
119-688 Cefadroxil Cefa-Tabs®
140-684 Cefadroxil Cefa-Drops®
141-285 Cefovecin sodium Convenia®
141-232 Cefpodoxime proxetil Simplicef®
200-543 Cefpodoxime proxetil Cefpodoxime Proxetil Tablets
141-209 Ceftiofur Crystalline Free Acid EXCEDE®
141-235 Ceftiofur Crystalline Free Acid EXCEDE® FOR SWINE
140-890 Ceftiofur Hydrochloride Excenel Sterile Suspension, Excenel® RTU,Excenel® Sterile Powder
141-238 Ceftiofur Hydrochloride Spectramast® LC Sterile Suspension
141-239 Ceftiofur Hydrochloride Spectramast™ DC Sterile Suspension
141-288 Ceftiofur Hydrochloride EXCENEL® RTU EZ
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:12
ApplicationNumber
Active Ingredients Trade Name
200-616 Ceftiofur Hydrochloride Cefenil® RTU
140-338 Ceftiofur Sodium Naxcel® Sterile Powder
200-420 Ceftiofur Sodium Ceftiofur Sodium Sterile Powder
141-326 Cephalexin Rilexine® Chewable Tablets
108-114 Cephapirin Benzathine ToMORROW®
097-222 Cephapirin Sodium ToDAY®
046-789 Chloral Hydrate Chloropent
141-423 Chloramine-T trihydrate HALAMID® AQUA
055-002 Chloramphenicol Tevcocin
055-051 Chloramphenicol Chloromycetin Tablets 100 mg, ChloromycetinTablets 250 mg, Chloromycetin Tablets 500 mg
055-059 Chloramphenicol Viceton® Tablets
065-149 Chloramphenicol Chloromycetin Ophthalmic Ointment
065-150 Chloramphenicol Chloramphenicol Capsules
065-241 Chloramphenicol Mychel-Vet Capsules (50 mg)
065-460 Chloramphenicol Chloramphenicol 1% Ophthalmic, VetrocloricinOphthalmic Ointment
065-461 Chloramphenicol Anacetin Tablets
065-463 Chloramphenicol Mychel-Vet Injection
065-489 Chloramphenicol Mychel-Vet Tabs
065-491 Chloramphenicol Medichol Tablets
055-047 Chloramphenicol Palmitate Chloromycetin Palmitate Oral Suspension
009-782 Chlorhexidine Acetate Nolvasan® Antiseptic Ointment
200-301 Chlorhexidine Acetate Privasan™ Antiseptic Ointment
009-809 Chlorhexidine Hydrochloride Nolvasan® Cap-Tabs®
010-434 Chlorhexidine Hydrochloride Nolvasan® Suspension
006-983 Chlorobutanol A-H Injection
141-245 Chloroquine Phosphate Tributame™ Euthanasia Solution
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:13
ApplicationNumber
Active Ingredients Trade Name
011-678 Chlorothiazide Diuril® Tablet
012-734 Chlorothiazide Diuril®
038-160 Chlorphenesin Carbamate Maolate® Tablets, Maolate® Veterinary
035-688 Chlortetracycline Aureomix® S 40/40 Granular
035-805 Chlortetracycline Aureo S 700® Granular, Aureo S 700®
036-361 Chlortetracycline Amprol Plus® and Aureomycin®
041-647 Chlortetracycline AUREOMIX® S 700-A
041-648 Chlortetracycline AUREOMIX® S 700-D
041-649 Chlortetracycline Aureomix® S 700-G
041-650 Chlortetracycline Aureomix® S 700-E
041-651 Chlortetracycline Aureomix® 700-F
041-652 Chlortetracycline Aureomix® S 700-C
041-653 Chlortetracycline AUREOMIX® S 700-B
041-654 Chlortetracycline AUREOMIX® S 700-H
045-444 Chlortetracycline Deccox® and Aureomycin®
046-209 Chlortetracycline COYDEN® plus CTC
048-761 Chlortetracycline Aureomycin® 50 Granular, Aureomycin®50 Granular A, Aureomycin® 70 Granular,Aureomycin® 80 Granular, Aureomycin® 90Granular, Aureomycin® 90 Meal, Aureomycin®100 Granular
092-507 Chlortetracycline Robenz® and Aureomycin®
100-901 Chlortetracycline PfiChlor® 100S
121-553 Chlortetracycline Aureomycin® / Coban™
138-934 Chlortetracycline Pennchlor S 40/40®
138-935 Chlortetracycline Pennchlor® 50™, Pennchlor 50 G®, Pennchlor®90 G™, Pennchlor® 100 G™, Pennchlor® 100Hi-Flo™
140-859 Chlortetracycline Bio-Cox®/Aureomycin®
141-011 Chlortetracycline Denagard® plus CTC
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:14
ApplicationNumber
Active Ingredients Trade Name
141-059 Chlortetracycline BMD® and ChlorMax®
141-147 Chlortetracycline Chlormax® and Deccox®
141-185 Chlortetracycline Aureomycin® / Deccox®
141-201 Chlortetracycline Aureomycin® and Cattlyst®
141-250 Chlortetracycline Aureomycin® and Bovatec®
141-530 Chlortetracycline MGA® and Aureomycin®
141-531 Chlortetracycline MGA® and Bovatec® and Aureomycin®
141-535 Chlortetracycline Aureo S 700® and Bovatec®
200-261 Chlortetracycline Bio-Cox® / ChlorMax™
200-262 Chlortetracycline ChlorMax® / Sacox®
200-263 Chlortetracycline ChlorMax™ / Coban®
200-314 Chlortetracycline Pennchlor S®
200-357 Chlortetracycline Pennchlor® / Bio-Cox®
200-358 Chlortetracycline BMD® Pennchlor®
200-359 Chlortetracycline Pennchlor® / Deccox®
200-510 Chlortetracycline Deracin® 50 Meal, Deracin® 90 Meal, Deracin®100 Meal
200-617 Chlortetracycline Deracin® plus Bovatec®
200-622 Chlortetracycline Deccox® plus Deracin®
200-633 Chlortetracycline Denagard® and Deracin®
055-012 Chlortetracycline Bisulfate Chloronex® Sulmet®
055-020 Chlortetracycline Bisulfate Aureomycin® Soluble Powder
065-486 Chlortetracycline Bisulfate CTC Bisulfate Soluble Powder
048-480 Chlortetracycline Calcium Complex Chloratet™ 100, Chloratet™ 50, Chloratet™ 90
049-287 Chlortetracycline Calcium Complex PfiChlor® 50, PfiChlor® 70, PfiChlor® 100
092-286 Chlortetracycline Calcium Complex CLTC® 10, CLTC® 20, CLTC® 30, CLTC® 50,CLTC® 70
200-095 Chlortetracycline Calcium Complex Aureomycin® / Sacox®
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:15
ApplicationNumber
Active Ingredients Trade Name
200-242 Chlortetracycline Calcium Complex BMD®-25, -30, -40, -50, -60, or -75 /Aureomycin® -50, -70, -80, -90 or -100
046-699 Chlortetracycline Hydrochloride ChlorMax® 50, ChlorMax® 65, ChlorMax® 70,ChlorMax® 100, Micro CTC®
055-018 Chlortetracycline Hydrochloride Chlortetracycline Hydrochloride Tablets
055-019 Chlortetracycline Hydrochloride Bulk Chlortetracycline Hydrochloride
055-039 Chlortetracycline Hydrochloride Aureomycin® Soluble Oblets
065-071 Chlortetracycline Hydrochloride CHLORTETRACYCLINE SOLUBLE POWDER
065-178 Chlortetracycline Hydrochloride Fermycin™ Soluble
065-256 Chlortetracycline Hydrochloride CHLORTET™-SOLUBLE-O
065-440 Chlortetracycline Hydrochloride Chloronex®
065-480 Chlortetracycline Hydrochloride Chlortetracycline hydrochloride soluble powder
065-481 Chlortetracycline Hydrochloride Calf Scour Boluses, Chlortetracycline Pneumonia
092-287 Chlortetracycline Hydrochloride CLTC® 50 MR, CLTC® 100 MR
200-236 Chlortetracycline Hydrochloride Chlortetracycline HCL Soluble Powder
200-295 Chlortetracycline Hydrochloride Pennchlor™ 64
200-354 Chlortetracycline Hydrochloride Pennchlor™ / Coban®
200-356 Chlortetracycline Hydrochloride Pennchlor™ / Denagard®
200-441 Chlortetracycline Hydrochloride Aureomycin®
006-103 Chorionic Gonadotropin Follutein Veterinary
140-856 Chorionic Gonadotropin P.G. 600®
140-927 Chorionic Gonadotropin Chorulon®
040-322 Chymotrypsin Kymar Ointment Improved
141-533 Ciclesonide Aservo® EquiHaler®
125-961 Citric Acid Re-Sorb, Vytrate
055-099 Clavulanate Potassium CLAVAMOX® CHEWABLE Tablets,CLAVAMOX® tablets
055-101 Clavulanate Potassium Clavamox® Drops
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:16
ApplicationNumber
Active Ingredients Trade Name
200-592 Clavulanate Potassium Clavacillin®
200-604 Clavulanate Potassium Amoxicillin and Clavulanate Potassium for OralSuspension
200-702 Clavulanate Potassium Amoxicillin and Clavulanate Potassium Tablets
200-709 Clavulanate Potassium Amoxicillin and Clavulanate Potassium for OralSuspension
140-973 Clenbuterol Hydrochloride Ventipulmin® Syrup
200-538 Clindamycin ClindaMed™ Oral Drops
120-161 Clindamycin Hydrochloride Antirobe® Capsules
135-940 Clindamycin Hydrochloride Antirobe Aquadrops®
200-193 Clindamycin Hydrochloride Clindamycin Hydrochloride Oral Liquid
200-291 Clindamycin Hydrochloride Clinsol®
200-298 Clindamycin Hydrochloride Clindamycin Hydrochloride Capsules
200-316 Clindamycin Hydrochloride Clintabs®
200-398 Clindamycin Hydrochloride Clindamycin Hydrochloride Oral Drops
141-427 Clodronate Osphos®
141-120 Clomipramine Hydrochloride Clomicalm® Tablets
200-635 Clomipramine Hydrochloride Clomipramine Hydrochloride Tablets
034-393 Clopidol Coyden 25®
046-209 Clopidol COYDEN® plus CTC
049-934 Clopidol Coyden 25® with Bacitracin Zinc
099-150 Clopidol BMD® and Coyden 25®
141-419 Clopidol Coyden® and Flavomycin®
141-485 Clopidol COYDEN® and LINCOMIX®
200-218 Clopidol Albac® / Coyden 25®
113-645 Cloprostenol Sodium Estrumate®, Heifex®
200-310 Cloprostenol Sodium estroPLAN™ Injection
136-742 Clorsulon Curatrem® Drench, Curatrem® Drench For Cattle
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:17
ApplicationNumber
Active Ingredients Trade Name
140-833 Clorsulon Ivomec® Plus Injection For Cattle
200-436 Clorsulon Normectin® Plus
200-450 Clorsulon Bimectin® Plus
200-466 Clorsulon SparMectin Plus Clorsulon
116-089 Clotrimazole Veltrim 1% Dermatologic Cream
140-896 Clotrimazole Otomax®
141-177 Clotrimazole Mometamax™ Otic Suspension
200-229 Clotrimazole Tri-Otic® Ointment
200-283 Clotrimazole Vetro-Max®
200-287 Clotrimazole GBC Ointment™
200-536 Clotrimazole Mometavet®
055-058 Cloxacillin Benzathine Dry-Clox® Intramammary Infusion
055-069 Cloxacillin Benzathine Orbenin DC
055-070 Cloxacillin Sodium Dariclox®
141-069 Colistimethate Sodium First Guard® Sterile Powder
011-644 Colloidal Ferric Oxide Felac
012-991 Copper Naphthenate Kopertox®
100-616 Copper Naphthenate Horseshoers Secret Thrush Treatment Aid, Thrush-XX
200-304 Copper Naphthenate Pritox®
008-760 Corticotropin Adrenomone
140-583 Corticotropin ACTH Gel
040-001 Coumaphos Meldane 2
141-552 Crofelemer CANALEVIA™-CA1
141-052 Cyclosporine Optimmune®
141-218 Cyclosporine Atopica™
200-627 Cyclosporine Sporimune®
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:18
ApplicationNumber
Active Ingredients Trade Name
200-692 Cyclosporine CYCLAVANCE™
141-329 Cyclosporine oral solution, USP Modified Atopica™ for Cats
033-342 Cythioate Proban® Cythioate Tablets 30 mg
033-606 Cythioate Proban® Oral Liquid
132-336 Cythioate Proban® Oral Liquid
132-337 Cythioate Proban® Tablets
141-207 Danofloxacin Advocin™ Sterile Injectable Solution
039-417 Decoquinate Deccox®
045-348 Decoquinate Albac® / Deccox®, Broiler Finisher Medicated
045-444 Decoquinate Deccox® and Aureomycin®
141-060 Decoquinate Deccox® - M Medicated Powder for Whole Milk
141-102 Decoquinate BMD® / Deccox®
141-147 Decoquinate Chlormax® and Deccox®
141-148 Decoquinate Deccox® / Rumensin®
141-149 Decoquinate Deccox® and Rumensin™ and Tylan™
141-185 Decoquinate Aureomycin® / Deccox®
141-483 Decoquinate Deccox® and LINCOMIX®
200-213 Decoquinate Albac® / Deccox®
200-359 Decoquinate Pennchlor® / Deccox®
200-533 Decoquinate Deccox®, Rumensin™, and Tylovet® 100
200-622 Decoquinate Deccox® plus Deracin®
200-652 Decoquinate Deccox® and Monovet®
200-653 Decoquinate Deccox® and Monovet® and Tylovet®
200-656 Decoquinate Deccox® and Monovet® and Tylan™
141-203 Deracoxib Deramaxx® Chewable Tablets
200-637 Deracoxib Doxidyl™
200-704 Deracoxib Deracoxib Chewable Tablets
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:19
ApplicationNumber
Active Ingredients Trade Name
141-044 Deslorelin Acetate Ovuplant™
141-319 Deslorelin Acetate SucroMate® Equine
141-029 Desoxycorticosterone Pivalate Percorten™-V
141-444 Desoxycorticosterone Pivalate Zycortal® Suspension
140-862 Detomidine Hydrochloride Dormosedan™
141-306 Detomidine Hydrochloride Dormosedan Gel®
200-674 Detomidine Hydrochloride Detomequin™
011-885 Dexamethasone Azium® Tablets 0.25 mg
011-901 Dexamethasone Azium® Aqueous Suspension Veterinary
012-559 Dexamethasone Azium® Solution
030-136 Dexamethasone Naquasone® Bolus
030-434 Dexamethasone Azium® Powder
030-435 Dexamethasone Azium® Boluses 10 mg
042-633 Dexamethasone Tresaderm Dermatologic Solution
092-835 Dexamethasone Azium® Oral Solution 2 mg
095-218 Dexamethasone Dexium™ Tablets
099-606 Dexamethasone Dexameth-A-Vet Injection
099-607 Dexamethasone Dexameth-A-Vet
108-687 Dexamethasone Pet Derm® III Tablets
111-369 Dexamethasone Dexamethasone Sterile Solution
128-089 Dexamethasone Zonometh Solution
130-660 Dexamethasone Dexachel
200-108 Dexamethasone Dexamethasone Solution
200-312 Dexamethasone Dexium®
200-324 Dexamethasone Dexamethasone Injection
200-456 Dexamethasone Dexamethasone Solution
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:20
ApplicationNumber
Active Ingredients Trade Name
200-565 Dexamethasone Thiabendazole, Dexamethasone, Neomycin SulfateSolution
099-604 Dexamethasone Sodium Phosphate Dex-A-Vet Injection
099-605 Dexamethasone Sodium Phosphate Dex-A-Vet Injection
123-815 Dexamethasone Sodium Phosphate Dexamethasone Sodium Phosphate Inj.
200-317 Dexamethasone Sodium Phosphate Dexium-SP™
093-600 Dexamethasone-21-isonicotinate Voren® Suspension
141-456 Dexmedetomidine SILEO®
141-267 Dexmedetomidine hydrochloride Dexdomitor®
200-573 Dexmedetomidine hydrochloride Dexmedesed®
200-699 Dexmedetomidine hydrochloride Dexmedetomidine Hydrochloride Injection
125-961 Dextrose Re-Sorb, Vytrate
091-192 Diatrizoate Meglumine Renografin®-76
091-240 Diatrizoate Meglumine Renovist
091-327 Diatrizoate Meglumine Gastrografin®
091-192 Diatrizoate Sodium Renografin®-76
091-240 Diatrizoate Sodium Renovist
091-327 Diatrizoate Sodium Gastrografin®
128-967 Dibucaine Hydrochloride Repose Euthanasia Solution
006-691 Dichlorophene Vermiplex
007-829 Dichlorophene Happy Jack Tapeworm Tablets
048-010 Dichlorophene Anaplex Caps, Canine and Feline Wormer Caps
095-333 Dichlorophene Difolin No. 1 Capsules, Difolin No. 2.5 Capsules,Difolin No. 25 Capsules, Difolin No. 40 Capsules,Difolin No. 5 Capsules
102-020 Dichlorophene Tri-Plex Worm Capsules
103-953 Dichlorophene Trivermicide Worm Capsules
107-189 Dichlorophene Worm Capsules
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:21
ApplicationNumber
Active Ingredients Trade Name
126-676 Dichlorophene D & T Worm Capsules
031-512 Dichlorvos Atgard® Swine Wormer 27 g, Atgard® SwineWormer 5.4g, Atgard® V Swine Wormer 27 g,Atgard® V Swine Wormer 5.4 g
033-803 Dichlorvos Task Dog Anthelmintic
035-918 Dichlorvos Equigard, Verdisol
040-848 Dichlorvos Atgard® C Swine Wormer
043-606 Dichlorvos Atgard® Swine Wormer, Atgard® V SwineWormer
048-237 Dichlorvos Equigel
048-271 Dichlorvos Task® Tabs
049-032 Dichlorvos Atgard® C Premix 9.6%
140-951 Diclazuril Clinacox™
141-153 Diclazuril Clinacox™ and BMD®
141-158 Diclazuril Clinacox™ and Flavomycin®
141-194 Diclazuril Clinacox™ and BMD®
141-195 Diclazuril Clinacox™ and Flavomycin®
141-268 Diclazuril Protazil™
141-472 Diclazuril Clinacox® and Stafac®
141-186 Diclofenac sodium Surpass® Topical Anti-Inflammatory Cream
055-032 Dicloxacillin Sodium Monohydrate Dicloxin Capsules
092-836 Diethylcarbamazine Citrate Diethylcarbamazine Citrate Tab., Diro-Form
092-837 Diethylcarbamazine Citrate Nemacide Oral Syrup
093-512 Diethylcarbamazine Citrate Dirocide Tablets
104-493 Diethylcarbamazine Citrate Filaribits® Chewable Tablets
107-506 Diethylcarbamazine Citrate Carbam® Tablets
118-032 Diethylcarbamazine Citrate Carbam® Palatabs®
120-326 Diethylcarbamazine Citrate Filban Chewable Wafers
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:22
ApplicationNumber
Active Ingredients Trade Name
124-842 Diethylcarbamazine Citrate Filban Tablets
127-627 Diethylcarbamazine Citrate Nemacide, Nemacide-C
128-069 Diethylcarbamazine Citrate Nemacide Chewable Tablets
128-517 Diethylcarbamazine Citrate Pet-Dec
131-808 Diethylcarbamazine Citrate Dirocide Syrup
136-483 Diethylcarbamazine Citrate Filaribits® Plus Chewable Tablets
141-096 Difloxacin Hydrochloride Dicural® Tablets
055-028 Dihydrostreptomycin Sulfate Quartermaster® Suspension
055-097 Dihydrostreptomycin Sulfate Dry-Mast
065-483 Dihydrostreptomycin Sulfate Pfizer-Strep
032-168 Dimethyl Sulfoxide Domoso® Solution
045-512 Dimethyl Sulfoxide Synotic® Otic Solution
047-334 Dimethyl Sulfoxide Synsac Solution
047-925 Dimethyl Sulfoxide Domoso® Gel
100-202 Dinoprost Tromethamine Prostin F2 Alpha® Sterile Solution
108-901 Dinoprost Tromethamine Lutalyse® Injection
141-442 Dinoprost Tromethamine LUTALYSE® HighCon Injection
200-253 Dinoprost Tromethamine ProstaMate®
047-870 Diprenorphine Hydrochloride M50-50 Diprenorphine, M99 Etorphine
141-513 Dipyrone Zimeta™
141-260 Dirlotapide Slentrol®
011-531 Dithiazanine Iodide Dizan Tablets
011-674 Dithiazanine Iodide Dizan Powder
012-469 Dithiazanine Iodide Dizan Suspension With Piperazine
141-314 domperidone Equidone® Gel
141-061 Doramectin Dectomax® Injectable Solution for Cattle andSwine
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:23
ApplicationNumber
Active Ingredients Trade Name
141-095 Doramectin Dectomax® Pour-on Solution for Cattle
034-879 Doxapram Hydrochloride Dopram®-V Injectable
141-082 Doxycycline Hyclate Doxirobe™ Gel
006-602 Doxylamine Succinate A-H-Tablets 100 mg, A-H-Tablets 25 mg
006-983 Doxylamine Succinate A-H Injection
030-438 Droperidol Innovar®-Vet Injection
140-818 Efrotomycin Producil® For Swine
141-245 Embutramide Tributame™ Euthanasia Solution
141-275 Emodepside Profender™
141-015 Enalapril Maleate Enacard® Tablets For Dogs
140-441 Enrofloxacin Baytril® Antibacterial Tablets, Baytril® TasteTabs® Antibacterial Tablets
140-913 Enrofloxacin Baytril® Antibacterial Injectable Solution
141-068 Enrofloxacin Baytril® 100 Injectable Solution
141-176 Enrofloxacin Baytril® Otic
141-527 Enrofloxacin Baytril® 100-CA1
200-495 Enrofloxacin Enroflox® 100
200-513 Enrofloxacin Enroflox™ Injection for Dogs 2.27%
200-517 Enrofloxacin Zobuxa™
200-527 Enrofloxacin Enrofloxacin Antibacterial Injectable Solution
200-551 Enrofloxacin Enrofloxacin Flavored Tablets
200-598 Enrofloxacin EnroMed™ 100
200-608 Enrofloxacin Baytril® Soft Chewable Tablets
200-628 Enrofloxacin ENROFLOXACIN 100
200-680 Enrofloxacin Enrofloxacin Flavored Tablets
200-688 Enrofloxacin Tenotryl™
200-697 Enrofloxacin Enrofloxacin
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:24
ApplicationNumber
Active Ingredients Trade Name
200-708 Enrofloxacin Enrofloxacin
200-720 Enrofloxacin Enroflox® Chewable Tablets
141-079 Eprinomectin Eprinex® Pour-On for Beef and Dairy Cattle
141-327 Eprinomectin Longrange®
141-492 Eprinomectin Centragard®
200-563 Eprinomectin Eprizero®
140-893 Epsiprantel Cestex®
012-123 Erythromycin Erythro® - 100, 200, Gallimycin®-100
035-455 Erythromycin Erythro®-36 Dry, Gallimycin®-36 Dry
035-456 Erythromycin Gallimycin®-36 Sterile
037-586 Erythromycin Erythromast 36
101-690 Erythromycin Erythro®-100 Injection
035-157 Erythromycin Phosphate Gallimycin® PFC
010-092 Erythromycin Thiocyanate Gallimycin®-100P
118-123 Estradiol Compudose™ 200, Encore™ (Compudose 400™ )
135-906 Estradiol Component™ E-H with Tylan™
140-897 Estradiol Revalor®-G, Revalor®-IS, Revalor®-S
140-992 Estradiol Revalor®-200, Revalor®-H, Revalor®-IH
141-269 Estradiol Revalor®-XH, Revalor®-XS
141-445 Estradiol Revalor®-XR
200-221 Estradiol Component™ TE-G, Component™ TE-G withTylan™, Component™ TE-ID with Tylan™,Component™ TE-IS, Component™ TE-IS withTylan™, Component™ TE-S, Component™ TE-Swith Tylan™
200-346 Estradiol Component™ TE-200 with Tylan™,Component™ TE-H with Tylan™, Component™TE-IH with Tylan™
200-367 Estradiol Synovex® T120, Synovex® T40, Synovex® T80
009-576 Estradiol Benzoate Synovex® C, Synovex® S
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:25
ApplicationNumber
Active Ingredients Trade Name
011-427 Estradiol Benzoate Synovex® H
110-315 Estradiol Benzoate Component™ E-C with Tylan™, Component™ E-S with Tylan™
141-043 Estradiol Benzoate SYNOVEX Choice®, SYNOVEX PLUS®
141-348 Estradiol Benzoate SYNOVEX® ONE FEEDLOT, SYNOVEX®ONE Grower
134-930 Estradiol Valerate Syncro-Mate-B®
141-325 estriol Incurin®
013-461 Ethopabate Amprol Hi-E, Amprol Plus
036-304 Ethopabate Amprol HI-E® Plus
036-361 Ethopabate Amprol Plus® and Aureomycin®
095-543 Ethopabate Amprol HI-E® & Bambermycins, Amprol HI-E® / Flavomycin®
114-794 Ethopabate Baciferm® / Amprol HI-E® Premix
200-205 Ethopabate Albac® / Amprol Hi-E®
011-222 Ethylisobutrazine Hydrochloride Diquel Tablet
035-265 Ethylisobutrazine Hydrochloride Diquel Solution
141-108 Etodolac EtoGesic® Tablets
141-274 Etodolac Etogesic® Sterile Injectable Solution
047-870 Etorphine Hydrochloride M50-50 Diprenorphine, M99 Etorphine
034-266 Famphur Famix Famphur Premix
034-697 Famphur Warbex® Famphur Cattle Pour-on
139-858 Famphur Tramisol®-X-Tra Cattle Anthelmintic andExtoparasitic Paste
107-345 Febantel Cutter Paste, Rintal® Paste
107-346 Febantel Rintal® Suspension
133-953 Febantel Vercom Paste Anthelmintic
140-912 Febantel Rintal® Tabs Anthelmintic Tablets
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:26
ApplicationNumber
Active Ingredients Trade Name
141-007 Febantel Drontal® Plus, Drontal® Plus Taste Tabs®, QuadDewormer
104-494 Fenbendazole Panacur® Suspension 10%
111-278 Fenbendazole Panacur® Granules 22.2%
120-648 Fenbendazole panacur®, safe-guard®
121-473 Fenbendazole Panacur® C (OTC), Safe-Guard® Canine (OTC),Panacur® Granules 22.2% (Rx)
128-620 Fenbendazole Safe-Guard® , Panacur®
131-675 Fenbendazole Safe-Guard®
132-872 Fenbendazole Panacur® 10% Paste, Safe-Guard®
137-600 Fenbendazole Safe-Guard® Type A Medicated Article
139-189 Fenbendazole Safe-Guard®
140-954 Fenbendazole SAFE-GUARD® plus LINCOMIX®
141-144 Fenbendazole BMD® / Safe-Guard®
141-286 Fenbendazole Panacur® Plus
141-449 Fenbendazole Safe-Guard® AquaSol
128-549 Fenprostalene Bovilene
138-903 Fenprostalene Porcilene® Solution
030-438 Fentanyl Citrate Innovar®-Vet Injection
034-641 Fenthion Tiguvon Pour-On Cattle Insecticide
047-138 Fenthion Spotton 20% Ready-to-Use Cattle Insecticide
132-789 Fenthion Pro-Spot Solution
141-230 Firocoxib Previcox® Chewable Tablets
141-253 Firocoxib Equioxx® Oral Paste
141-313 Firocoxib Equioxx® Injection
141-458 Firocoxib Equioxx®
200-722 Firocoxib Firox™
141-063 Florfenicol Nuflor® , Nuflor®-S
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:27
ApplicationNumber
Active Ingredients Trade Name
141-206 Florfenicol Nuflor® Concentrate Solution
141-246 Florfenicol Aquaflor® Type A Medicated Article
141-264 Florfenicol Nuflor®
141-265 Florfenicol NuflorGOLD™
141-299 Florfenicol Resflor Gold®
141-437 Florfenicol Osurnia™
141-440 Florfenicol CLARO™
200-519 Florfenicol Florvio™ 2.3% Concentrate Solution
200-582 Florfenicol Loncor™ 300
200-588 Florfenicol FLORFENICOL INJECTION
200-589 Florfenicol FLORCON
200-591 Florfenicol Norfenicol®
030-414 Flumethasone Flucort® Solution
030-415 Flumethasone Flucort® Tablets
036-211 Flumethasone Anaprime® Suspension
038-801 Flumethasone Anaprime® Ophthalmic Solution
049-725 Flumethasone Anaprime® Opthakote Ophthalmic
036-212 Flumethasone Acetate Fluosmin Suspension
141-450 Flunixin Banamine® Transdermal
101-479 Flunixin Meglumine Banamine® , Banamine®-S
106-616 Flunixin Meglumine Banamine® Granules
137-409 Flunixin Meglumine Banamine® Paste
141-299 Flunixin Meglumine Resflor Gold®
141-312 Flunixin Meglumine Hexasol® Injection
200-061 Flunixin Meglumine Flu-Nix™
200-124 Flunixin Meglumine Flunixin Meglumine Injection
200-142 Flunixin Meglumine Flunixin Meglumine Solution
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:28
ApplicationNumber
Active Ingredients Trade Name
200-308 Flunixin Meglumine Flunixin Injection
200-387 Flunixin Meglumine Flunazine™
200-476 Flunixin Meglumine Flunixin Injection - S
200-489 Flunixin Meglumine Flunazine®-S
200-581 Flunixin Meglumine Flunazine®
015-151 Fluocinolone Acetonide Neo-synalar Cream
015-152 Fluocinolone Acetonide Synalar® Cream Veterinary
015-298 Fluocinolone Acetonide Synalar® Solution Veterinary
045-512 Fluocinolone Acetonide Synotic® Otic Solution
047-334 Fluocinolone Acetonide Synsac Solution
141-272 Fluoxetine hydrochloride Reconcile®
111-529 Fluprostenol Sodium Equimate®
141-426 Fluralaner BRAVECTO®
141-459 Fluralaner BRAVECTO®
141-518 Fluralaner BRAVECTO® PLUS
141-532 Fluralaner BRAVECTO® 1-MONTH
141-014 Follicle Stimulating Hormone Super-Ov®
137-687 Formalin Formalin-F
140-989 Formalin PARASITE-S
200-414 Formalin Formacide-B
141-546 Frunevetmab Solensia™
032-319 Furazolidone Furox® Aerosol Powder, Topazone AerosolPowder
111-104 Furazolidone Furall
034-478 Furosemide Salix™ Injection 5%
034-621 Furosemide Salix® Tablets
045-188 Furosemide Lasix® Packets
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:29
ApplicationNumber
Active Ingredients Trade Name
102-380 Furosemide Lasix® Syrup 1%
118-550 Furosemide Furos-A-Vet
127-034 Furosemide Disal® Injection
129-034 Furosemide Disal®
131-538 Furosemide Disal®
200-293 Furosemide Furosemide Injection 5%
200-373 Furosemide Furosemide Syrup 1%
200-382 Furosemide Furosemide Syrup 1%
141-328 Gamithromycin Zactran®
006-281 Gelatin Intragel
034-267 Gentamicin Sulfate Gentocin® Durafilm®
038-292 Gentamicin Sulfate Gentocin® Solution
046-724 Gentamicin Sulfate Gentocin® Solution
046-821 Gentamicin Sulfate Gentocin® Otic Solution
091-191 Gentamicin Sulfate Garacin®
092-523 Gentamicin Sulfate Garasol® Solution
098-989 Gentamicin Sulfate Gentocin® Ophthalmic Ointment
099-008 Gentamicin Sulfate Gentocin® Ophthalmic Solution
101-862 Gentamicin Sulfate Garasol® Injection
103-037 Gentamicin Sulfate Garacin® Piglet Injection
113-231 Gentamicin Sulfate Topagen® Ointment
130-464 Gentamicin Sulfate Gentocin® (Garacin) Pig Pump Oral Solution
130-952 Gentamicin Sulfate Gentocin® Pink Eye Spray
132-338 Gentamicin Sulfate Gentocin® Topical Spray
133-836 Gentamicin Sulfate Garacin® Soluble Powder
137-310 Gentamicin Sulfate Gentamicin Sulfate Inj. Sol.
140-896 Gentamicin Sulfate Otomax®
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:30
ApplicationNumber
Active Ingredients Trade Name
141-177 Gentamicin Sulfate Mometamax™ Otic Suspension
141-330 Gentamicin Sulfate Easotic®
200-023 Gentamicin Sulfate Gentamicin Sulfate Solution 100 mg/ml
200-037 Gentamicin Sulfate Gentamicin Sulfate Solution, Legacy SterileSolution
200-102 Gentamicin Sulfate Gentaglyde™ Solution
200-115 Gentamicin Sulfate Gentamex™ 100
200-137 Gentamicin Sulfate GentaMax® 100
200-147 Gentamicin Sulfate Genta-Ject®, Gentamicin Sulfate Injection
200-174 Gentamicin Sulfate Gentamicin Sulfate Pig Pump Oral Solution
200-183 Gentamicin Sulfate VET BETA-GEN®
200-185 Gentamicin Sulfate GEN-GARD®
200-188 Gentamicin Sulfate Betagen™ Topical Spray
200-190 Gentamicin Sulfate GENTORAL®
200-191 Gentamicin Sulfate Gentasol
200-229 Gentamicin Sulfate Tri-Otic® Ointment
200-273 Gentamicin Sulfate Vetro-Gen™ Veterinary Ophthalmic Ointment
200-283 Gentamicin Sulfate Vetro-Max®
200-287 Gentamicin Sulfate GBC Ointment™
200-388 Gentamicin Sulfate GB Topical Spray
200-394 Gentamicin Sulfate Gentamicin Piglet Injection
200-395 Gentamicin Sulfate Gentamicin Sulfate Solution
200-415 Gentamicin Sulfate Gentamicin Sulfate Topical Spray
200-416 Gentamicin Sulfate Gentamicin Topical Spray
200-468 Gentamicin Sulfate GentaMed™-P for Poultry Injection
200-494 Gentamicin Sulfate GentaMed™
200-536 Gentamicin Sulfate Mometavet®
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:31
ApplicationNumber
Active Ingredients Trade Name
200-576 Gentamicin Sulfate Gentamicin Sulfate Ophthalmic Solution
110-399 Gleptoferron Gleptosil, Heptomer Injection
200-587 Gleptoferron FerroForte®
125-961 Glycine Re-Sorb, Vytrate
101-777 Glycopyrrolate Robinul®-V Injectable
200-365 Glycopyrrolate Glycopyrrolate Injectable, Robinul®-V
098-379 Gonadorelin CYSTORELIN®
200-069 Gonadorelin Fertelin™, OvaCyst™
200-134 Gonadorelin acetate FERTAGYL®
200-541 Gonadorelin acetate Gonabreed™
139-237 Gonadorelin Hydrochloride Factrel®, Factrel® Injection
141-322 Gonadotropin Releasing Factor –Diphtheria Toxoid conjugate
Improvest®
141-455 Grapiprant GALLIPRANT®
012-227 Griseofulvin Fulvicin U/F® Tablets
013-755 Griseofulvin Grysio (Microsize)
031-447 Griseofulvin Fulvicin U/F® Bolus Veterinary
039-792 Griseofulvin Fulvicin U/F® Powder
200-391 Griseofulvin Griseofulvin Powder
044-012 Guaifenesin Gecolate
048-854 Guaifenesin Gecolate, Glycodex Injection
136-651 Guaifenesin Guailaxin
200-230 Guaifenesin Guaifenesin Injection
130-951 Halofuginone Hydrobromide Stenorol®
137-483 Halofuginone Hydrobromide Flavomycin® / Stenorol®
140-584 Halofuginone Hydrobromide BMD / Stenorol®
140-824 Halofuginone Hydrobromide Stenorol® Type A Medicated Article
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:32
ApplicationNumber
Active Ingredients Trade Name
140-918 Halofuginone Hydrobromide Flavomycin® / Stenorol®
140-919 Halofuginone Hydrobromide BMD® / Stenorol®
141-473 Halofuginone Hydrobromide Stenorol® and LINCOMIX®
014-170 Halothane Fluothane, Halothane, USP
048-913 Haloxon Halox Wormer Drench
092-483 Haloxon Halox Bolus
141-383 Helium, USP None (Med Gas)
141-389 Helium, USP None (Med Gas)
141-395 Helium, USP None (Med Gas)
141-404 Helium, USP None (Med Gas)
141-405 Helium, USP None (Med Gas)
141-416 Helium, USP None (Med Gas)
141-425 Helium, USP None (Med Gas)
141-500 Helium, USP None (Med Gas)
141-067 Hemoglobin Glutamer-200 (bovine) Oxyglobin®
055-021 Hetacillin Potassium Hetacin® K Capsules Vet
055-022 Hetacillin Potassium Hetacin® K Tablets
055-048 Hetacillin Potassium Hetacin® K Oral Liquid
055-054 Hetacillin Potassium PolyMast® Intramammary Infusion
141-453 hLAL rDNA construct hLAL rDNA construct in SBC LAL-C chickens
112-048 Hyaluronate Sodium Hylartin® V, Hylartin® V Injection
122-578 Hyaluronate Sodium Hyvisc®
139-913 Hyaluronate Sodium Equron®
140-474 Hyaluronate Sodium Synacid™
140-806 Hyaluronate Sodium Hyalovet®
140-883 Hyaluronate Sodium Legend® Injectable Solution, Legend® MultiDose
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:33
ApplicationNumber
Active Ingredients Trade Name
200-432 Hyaluronate Sodium NexHA™
013-674 Hydrochlorothiazide Hydrozide Injection
013-293 Hydrocortisone Liqua-Cortril Spray, Terra-Cortril Spray
065-476 Hydrocortisone Cortisporin Veterinary Ophthalmic Ointment
141-330 Hydrocortisone aceponate Easotic®
010-524 Hydrocortisone Acetate Neo-Cortef® with Tetracaine
040-322 Hydrocortisone Acetate Kymar Ointment Improved
043-784 Hydrocortisone Acetate Kanfosone Ointment
047-997 Hydrocortisone Acetate Amphoderm Ointment
065-015 Hydrocortisone Acetate Bacitracin-Neomycin-Polymyxin withHydrocortisone Acetate Ophthalmic Ointment,Vetropolycin HC Ophthalmic Ointment
065-119 Hydrocortisone Acetate Forte Topical® Ointment
093-514 Hydrocortisone Acetate Neo-Cortef® Sterile Ointment
141-255 Hydrogen Peroxide 35% PEROX-AID®
010-918 Hygromycin B Hygromix™ 8, Hygromix™ 2.4
011-948 Hygromycin B Hygromix 2.4
141-509 Imepitoin Pexion™
141-208 Imidacloprid Advantage® DUO
141-251 Imidacloprid Advantage Multi™ for Dogs
141-254 Imidacloprid Advantage Multi® for Cats
141-435 Imidacloprid advantus™
200-615 Imidacloprid IMOXI™ Topical Solution for Dogs
200-638 Imidacloprid IMOXI™ Topical Solution for Cats
200-700 Imidacloprid PARASEDGE™ Multi for Dogs
200-701 Imidacloprid PARASEDGE™ Multi for Cats
200-714 Imidacloprid Barrier™ for cats
200-716 Imidacloprid Midamox™ for Dogs
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:34
ApplicationNumber
Active Ingredients Trade Name
200-718 Imidacloprid Barrier™ for dogs
200-721 Imidacloprid Midamox™ for Cats
097-288 Imidocarb Dipropionate Imizol® Equine Injection
141-071 Imidocarb Dipropionate Imizol®
141-297 Insulin ProZinc®
005-633 Iodinated Casein Protomone Thyroactive Casein
013-502 Iodinated Casein Protamone-D
031-448 Iodochlorhydroxyquin Rheaform Bolus
010-793 Iron Dextran Complex Nonemic
010-865 Iron Dextran Complex Ferrextran 100
011-879 Iron Dextran Complex Rubrafer, Rubrafer S-100
099-667 Iron Dextran Complex Imposil
106-772 Iron Dextran Complex Uniferon® 100
119-142 Iron Dextran Complex PVL Iron Dextran Injectable
134-708 Iron Dextran Complex Uniferon® 200
138-255 Iron Dextran Complex Iron Hydrogenated Dextran Injection
200-254 Iron Dextran Complex Iron Dextran Injection, Iron Dextran Injection100mg
200-256 Iron Dextran Complex Iron Dextran Injection - 200
011-789 Isoflupredone Acetate Predef® 2x Sterile Aqueous Suspension
015-433 Isoflupredone Acetate Neo-Predef® with Tetracaine Powder
030-025 Isoflupredone Acetate Neo-Predef® with Tetracaine Top. Ointment,Tritop® Topical Ointment
034-872 Isoflupredone Acetate Neo Predef® Sterile Ointment
200-070 Isoflurane IsoFlo™
200-129 Isoflurane Isoflurane, USP
200-141 Isoflurane ATTANE™
200-237 Isoflurane Isoflurane, USP
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:35
ApplicationNumber
Active Ingredients Trade Name
013-201 Isopropamide Iodide Darbazine Spansule Capsule No.1
015-147 Isopropamide Iodide Darbazine Injectable
031-914 Isopropamide Iodide Neo-Darbazine Spansule Capsule No.1, Neo-Darbazine Spansule Capsule No.3
141-474 Itraconazole Itrafungol™
127-443 Ivermectin Eqvalan® Injection
128-409 Ivermectin Ivomec® .27% Injection Grower And Feeder Pigs,Ivomec® 1% Injection, Ivomec® 1% Injection forCattle And Swine, Ivomec® Injection for Cattle
131-392 Ivermectin Ivomec® Liquid
134-314 Ivermectin EQVALAN®
137-006 Ivermectin Ivomec® Cattle Paste 0.153%
138-412 Ivermectin Heartgard 30®, Heartgard® Tablets
140-439 Ivermectin Eqvalan® Oral Liquid For Horses
140-833 Ivermectin Ivomec® Plus Injection For Cattle
140-841 Ivermectin Ivomec® Pour-On
140-886 Ivermectin Heartgard® Chewables For Dogs
140-971 Ivermectin Heartgard® Plus
140-974 Ivermectin Ivomec® Premix for Swine
140-988 Ivermectin Ivomec® Sustained-Release Bolus for Cattle
141-078 Ivermectin Heartgard® for Cats
141-097 Ivermectin BMD® / Ivomec® Premix for Swine
141-174 Ivermectin Acarexx®
141-208 Ivermectin Advantage® DUO
141-214 Ivermectin ZIMECTERIN® Gold Paste
141-215 Ivermectin Equimax®
141-241 Ivermectin Zimecterin-EZ™
141-257 Ivermectin Iverhart Max®
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:36
ApplicationNumber
Active Ingredients Trade Name
141-286 Ivermectin Panacur® Plus
141-421 Ivermectin Duocare™
141-441 Ivermectin IVERHART MAX® Chew
200-202 Ivermectin Phoenectin®
200-219 Ivermectin Ivermectin Pour-On for Cattle, Phoenectin®,Phoenectin™, Phoenectin™ Pour-On for Cattle
200-228 Ivermectin Phoenectin®
200-270 Ivermectin Iverhart™ Tablets
200-272 Ivermectin Noromectin® Pour-On for Cattle
200-286 Ivermectin Phoenectin® Paste 1.87%
200-292 Ivermectin Iversol Liquid for Horses
200-297 Ivermectin Ivermectin Chewable Tablets
200-299 Ivermectin Iver-On™
200-302 Ivermectin Iverhart™ Plus Flavored Chewables
200-318 Ivermectin Bimectin® Pour-On
200-320 Ivermectin Equell®
200-321 Ivermectin Primectin™ Equine Oral Liquid
200-326 Ivermectin Bimectin®
200-327 Ivermectin Privermectin™ Drench for Sheep
200-338 Ivermectin Tri-Heart Plus Chewable Tablets
200-340 Ivermectin Privermectin®
200-341 Ivermectin SparMectin-E
200-348 Ivermectin Ecomectin
200-390 Ivermectin Ivermectin Paste 1.87 %
200-429 Ivermectin Ivermectin Injection
200-436 Ivermectin Normectin® Plus
200-437 Ivermectin Noromectin®
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:37
ApplicationNumber
Active Ingredients Trade Name
200-447 Ivermectin Bimectin® Injection for Cattle and Swine
200-450 Ivermectin Bimectin® Plus
200-466 Ivermectin SparMectin Plus Clorsulon
200-506 Ivermectin Animec™ Plus
200-564 Ivermectin Ivermectin Paste 1.87%
041-836 Kanamycin Sulfate Kantrim® 200
042-548 Kanamycin Sulfate Amforol® Suspension
042-661 Kanamycin Sulfate Kantrim® Ophthalmic Ointment
042-841 Kanamycin Sulfate Amforol® Veterinary Oral Tablets
042-883 Kanamycin Sulfate Kantrim® Ophthalmic Solution
043-784 Kanamycin Sulfate Kanfosone Ointment
047-997 Kanamycin Sulfate Amphoderm Ointment
043-304 Ketamine Hydrochloride Ketaset®
045-290 Ketamine Hydrochloride Ketaset®, Vetalar®
092-116 Ketamine Hydrochloride Ketaset® Plus
200-029 Ketamine Hydrochloride Ketamine Hydrochloride Injection
200-042 Ketamine Hydrochloride Ketamine Hydrochloride Injection, USP
200-055 Ketamine Hydrochloride VetaKet®
200-073 Ketamine Hydrochloride Ketamine Hydrochloride Injection, USP
200-257 Ketamine Hydrochloride Ketamine HCL
140-269 Ketoprofen KETOFEN®
141-543 Ketoprofen Draxxin® KP
200-625 Ketoprofen KetoMed™
141-025 Laidlomycin Propionate Potassium Cattlyst®
141-201 Laidlomycin Propionate Potassium Aureomycin® and Cattlyst®
096-298 Lasalocid Avatec®, Bovatec® 150 FP, Bovatec® 68 Type AMedicated Article, Bovatec® 91, Bovatec® Liquid20 (liquid Type A Article)
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:38
ApplicationNumber
Active Ingredients Trade Name
107-996 Lasalocid Avatec® / Fortracin Premix
138-993 Lasalocid MoorMan's® Cattle Minerals BT
139-876 Lasalocid Bovatec® / MGA® 100, Bovatec® / MGA® 200
140-288 Lasalocid Bovatec® / MGA® 500
140-579 Lasalocid BOVATEC® and TM®
141-083 Lasalocid Avatec® / Baciferm®
141-109 Lasalocid Avatec® / Baciferm®
141-129 Lasalocid Avatec® / Flavomycin®
141-171 Lasalocid Purina Sugar Mag Block 1440 BVT MedicatedMineral Block
141-179 Lasalocid Avatec® / BMD®
141-181 Lasalocid Avatec® / Albac®
141-187 Lasalocid Crystalyx® Iono-Lyx®
141-488 Lasalocid Avatec® and LINCOMIX®
141-531 Lasalocid MGA® and Bovatec® and Aureomycin®
141-535 Lasalocid Aureo S 700® and Bovatec®
200-430 Lasalocid HeifermaX® 500 plus Bovatec® and Tylan™
200-451 Lasalocid HeifermaX® 500 plus Bovatec®
200-535 Lasalocid MGA®/ Bovatec®/ Tylovet® 100
200-617 Lasalocid Deracin® plus Bovatec®
138-992 Lasalocid sodium MGA® and Bovatec® and Tylan™
141-250 Lasalocid sodium Aureomycin® and Bovatec®
141-470 Lasalocid sodium Stafac® and Avatec®
139-877 Levamisole Totalon™ Topical Cattle Anthelmintic
140-844 Levamisole Tramisol® Pour-On
039-356 Levamisole Hydrochloride Ripercol L Bolus, Tramisol® Cattle Wormer Bolus
039-357 Levamisole Hydrochloride Ripercol L Soluble Drench Powder
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:39
ApplicationNumber
Active Ingredients Trade Name
042-740 Levamisole Hydrochloride Ripercol L, Tramisol® Soluble Drench Powder forSheep
042-837 Levamisole Hydrochloride Ripercol L Wormer Oblets, Tramisol® SheepWormer Oblets
045-513 Levamisole Hydrochloride Ripercol L
091-826 Levamisole Hydrochloride Levasole® Cattle Wormer Bolus
092-237 Levamisole Hydrochloride Ripercol L-Piperazine Soluble
093-688 Levamisole Hydrochloride Ripercol L-Piperazine
107-085 Levamisole Hydrochloride Tramisol®
112-049 Levamisole Hydrochloride Levasole® Soluble Pig Wormer
112-050 Levamisole Hydrochloride Levasole
112-051 Levamisole Hydrochloride Levamisole Soluble Drench Powder, Levasole®,Levasole® Soluble Drench Powder, Tramisol®Soluble Drench Powder
112-052 Levamisole Hydrochloride Levasole® Sheep Wormer Bolus, Tramisole SheepWormer Oblets Tablets
126-237 Levamisole Hydrochloride Tramisol® Gel
200-225 Levamisole Hydrochloride Prohibit® Soluble Drench Powder
200-313 Levamisole Hydrochloride LevaMed™
200-386 Levamisole Hydrochloride LevaMed™ Soluble Drench Powder
049-553 Levamisole Phosphate Ripercol L
102-437 Levamisole Phosphate Tramisol® Injectable Solution
126-742 Levamisole Phosphate Levasole® Injectable Solution
200-271 Levamisole Phosphate Levamisole Phosphate
139-858 Levamisole Resinate Tramisol®-X-Tra Cattle Anthelmintic andExtoparasitic Paste
141-448 Levothyroxine sodium Thyro-Tabs® Canine
141-539 Levothyroxine sodium ThyroKare™
013-146 Lidocaine Liquamycin® Intramuscular
049-948 Lidocaine Aquachel 100 mg
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:40
ApplicationNumber
Active Ingredients Trade Name
141-245 Lidocaine Tributame™ Euthanasia Solution
097-505 Lincomycin LINCOMIX® 20, LINCOMIX® 50
140-954 Lincomycin SAFE-GUARD® plus LINCOMIX®
141-473 Lincomycin Stenorol® and LINCOMIX®
141-482 Lincomycin Robenz® and LINCOMIX®
141-483 Lincomycin Deccox® and LINCOMIX®
141-484 Lincomycin Bio-Cox® and LINCOMIX®
141-485 Lincomycin COYDEN® and LINCOMIX®
141-488 Lincomycin Avatec® and LINCOMIX®
141-489 Lincomycin Zoamix® and LINCOMIX®
141-491 Lincomycin Coban™ and LINCOMIX®
200-274 Lincomycin Lincomycin Injectable 30%
200-315 Lincomycin Lincomycin 100, Lincomycin 25, Lincomycin 300,Lincomycin Injection 100, Lincomycin Injection25, Lincomycin Injection 300
200-351 Lincomycin Lincomycin Injectable, USP
111-636 Lincomycin Hydrochloride LINCOMIX® Soluble Powder
138-941 Lincomycin Hydrochloride LINCOMIX® and Banminth®
200-189 Lincomycin Hydrochloride Lincomycin Soluble
200-233 Lincomycin Hydrochloride Linco Soluble
200-241 Lincomycin Hydrochloride Lincosol Soluble Powder
200-303 Lincomycin Hydrochloride Lincomycin Hydrochloride Soluble Powder
200-368 Lincomycin Hydrochloride LincoMed™ 100, LincoMed® 300
200-377 Lincomycin Hydrochloride LinxMed-SP®
200-407 Lincomycin Hydrochloride Lincomycin-Spectinomycin Water Soluble Powder
033-887 Lincomycin Hydrochloride Monohydrate Lincocin® Tablets
034-025 Lincomycin Hydrochloride Monohydrate Lincocin®, Lincomix® 25 Injectable, Lincomix®50 Injectable, Lincomix® 100 Injectable,Lincomix® 300 Injectable
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:41
ApplicationNumber
Active Ingredients Trade Name
040-587 Lincomycin Hydrochloride Monohydrate Lincocin® Aquadrops
046-109 Lincomycin Hydrochloride Monohydrate L-S 50 Water Soluble® Powder
116-044 Lincomycin Hydrochloride Monohydrate LINCOMIX® and Banminth®
200-345 Lincomycin Hydrochloride Monohydrate Lincomycin - Spectinomycin
200-380 Lincomycin Hydrochloride Monohydrate SpecLinx-50®
014-366 Liothyronine Sodium Cytobin Tablets
141-494 Lotilaner Credelio™
141-528 Lotilaner Credelio™ CAT
141-508 Lubabegron Experior™ 10, Experior™ 50
141-512 Lubabegron Experior™ and Rumensin™ and Tylan™
141-514 Lubabegron Experior™ and Rumensin™
141-026 Lufenuron Program™ Suspension
141-035 Lufenuron Program® Flavor Tabs®
141-062 Lufenuron Program® Cat Flavor Tabs™
141-084 Lufenuron Sentinel® Flavor Tabs®
141-105 Lufenuron Program™ 6 Month Injectable for Cats
141-204 Lufenuron Sentinel® Flavor Tabs® and Capstar® FleaManagement System™
141-205 Lufenuron Program® Flavor Tabs® and Capstar® FleaManagement System™
141-333 Lufenuron Sentinel® Spectrum®
140-857 Luprostiol Equestrolin™
139-075 Maduramicin Ammonium Cygro®
046-789 Magnesium Sulfate Chloropent
141-151 Marbofloxacin Zeniquin®
200-586 Marbofloxacin Marboquin™
141-262 Maropitant Cerenia® Tablets
141-263 Maropitant Cerenia® Injectable Solution
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:42
ApplicationNumber
Active Ingredients Trade Name
091-736 Mebendazole Telmin® Equine Wormer
097-221 Mebendazole Telmin® Syringe Formula
100-402 Mebendazole Telmin® B Equine Wormer
102-987 Mebendazole Telmintic Powder
118-394 Mebendazole Telmin®
138-954 Mebendazole Telmin® B Paste
095-641 Meclofenamic Acid Arquel Granules
110-201 Meclofenamic Acid Arquel Tablets
140-999 Medetomidine Domitor®
141-551 Medetomidine hydrochloride Zenalpha®
200-610 Medetomidine hydrochloride Placadine™
141-351 Medical Air, USP None (Med Gas)
141-363 Medical Air, USP None (Med Gas)
141-366 Medical Air, USP None (Med Gas)
141-367 Medical Air, USP None (Med Gas)
141-368 Medical Air, USP None (Med Gas)
141-370 Medical Air, USP None (Med Gas)
141-376 Medical Air, USP None (Med Gas)
141-377 Medical Air, USP None (Med Gas)
141-379 Medical Air, USP None (Med Gas)
141-384 Medical Air, USP None (Med Gas)
141-386 Medical Air, USP None (Med Gas)
141-391 Medical Air, USP None (Med Gas)
141-400 Medical Air, USP None (Med Gas)
141-402 Medical Air, USP None (Med Gas)
141-403 Medical Air, USP None (Med Gas)
141-409 Medical Air, USP None (Med Gas)
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:43
ApplicationNumber
Active Ingredients Trade Name
141-410 Medical Air, USP None (Med Gas)
141-428 Medical Air, USP None (Med Gas)
141-432 Medical Air, USP None (Med Gas)
141-493 Medical Air, USP None (Med Gas)
091-603 Megestrol Acetate Ovaban® Tablets 20 mg, Ovaban® Tablets 5 mg
141-042 Melarsomine Dihydrochloride Immiticide Sterile Powder
200-609 Melarsomine Dihydrochloride DIROBAN®
140-846 Melatonin PrimeX®
034-254 Melengestrol Acetate MGA® 100, MGA® 200
039-402 Melengestrol Acetate MGA® 100, MGA® 200, MGA® 500
046-718 Melengestrol Acetate MGA® (liquid) and TM®
046-719 Melengestrol Acetate MGA® and TM®
124-309 Melengestrol Acetate MGA® 100-200 / Rumensin®, MGA® 100-200Premix / Rumensin®
125-476 Melengestrol Acetate MGA® 500 plus Rumensin®
138-870 Melengestrol Acetate MGA® and Rumensin™ and Tylan™
138-992 Melengestrol Acetate MGA® and Bovatec® and Tylan™
138-995 Melengestrol Acetate MGA® and Tylan™
139-192 Melengestrol Acetate MGA® and Tylan™
139-876 Melengestrol Acetate Bovatec® / MGA® 100, Bovatec® / MGA® 200
140-288 Melengestrol Acetate Bovatec® / MGA® 500
141-233 Melengestrol Acetate Optaflexx™ and Rumensin™ and Tylan™andMGA®
141-234 Melengestrol Acetate Optaflexx™ / Rumensin® / MGA®
141-280 Melengestrol Acetate Zilmax® and Rumensin™ and Tylan™ andMGA®
141-282 Melengestrol Acetate Zilmax®/Rumensin®/MGA®
141-284 Melengestrol Acetate Zilmax® plus MGA®
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:44
ApplicationNumber
Active Ingredients Trade Name
141-530 Melengestrol Acetate MGA® and Aureomycin®
141-531 Melengestrol Acetate MGA® and Bovatec® and Aureomycin®
200-343 Melengestrol Acetate Heifermax™ 500
200-375 Melengestrol Acetate HeifermaX™ 500 / Rumensin™ / Tylan™
200-399 Melengestrol Acetate CycleGuard® 500
200-422 Melengestrol Acetate Heifermax 500 Liquid Premix and Rumensin®
200-424 Melengestrol Acetate Heifermax™ / Optaflexx® / Rumensin® / Tylan®
200-427 Melengestrol Acetate Heifermax™ 500 Liquid Premix and Tylan®
200-430 Melengestrol Acetate HeifermaX® 500 plus Bovatec® and Tylan™
200-448 Melengestrol Acetate Heifermax 500®/Optaflexx®/Rumensin®
200-451 Melengestrol Acetate HeifermaX® 500 plus Bovatec®
200-479 Melengestrol Acetate Heifermax® 500/Zilmax®/Rumensin®
200-480 Melengestrol Acetate Heifermax® 500/Zilmax®/Rumensin®/Tylan®
200-483 Melengestrol Acetate Heifermax® 500 plus Zilmax®
200-532 Melengestrol Acetate MGA® plus Tylovet® 100
200-534 Melengestrol Acetate MGA®, Rumensin™ and Tylovet® 100
200-535 Melengestrol Acetate MGA®/ Bovatec®/ Tylovet® 100
200-544 Melengestrol Acetate Zilmax®/Rumensin®/Tylovet® 100/MGA®
200-560 Melengestrol Acetate Actogain™ 45/Rumensin®/MGA®
200-562 Melengestrol Acetate Actogain™ 45/Rumensin®/Tylan®/MGA®
200-567 Melengestrol Acetate Optaflexx™ 45/Rumensin®/Tylovet® 100/MGA®
200-583 Melengestrol Acetate Actogain™ 45/Rumensin®/Tylovet® 100/MGA®
200-648 Melengestrol Acetate Optaflexx™ and Monovet® and Tylovet® andMGA®
200-649 Melengestrol Acetate Actogain™ and Monovet® and Tylovet® andMGA®
200-650 Melengestrol Acetate Optaflexx™ and Monovet® and Tylan™ andMGA®
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:45
ApplicationNumber
Active Ingredients Trade Name
200-651 Melengestrol Acetate Actogain™ and Monovet® and Tylan™ andMGA®
200-658 Melengestrol Acetate MGA® and Monovet®
200-659 Melengestrol Acetate Actogain™ and Monovet® and MGA®
200-660 Melengestrol Acetate MGA® and Monovet® and Tylovet®
200-661 Melengestrol Acetate MGA® and Monovet® and Tylan™
200-677 Melengestrol Acetate Optigrid® and Monovet® and MGA®
200-678 Melengestrol Acetate Optigrid® and Monovet® and Tylovet® andMGA®
200-684 Melengestrol Acetate Optigrid® and Monovet® and CycleGuard®
200-685 Melengestrol Acetate CycleGuard® and Monovet® and Tylovet®
200-686 Melengestrol Acetate Optigrid® and Monovet® and Tylovet® andCycleGuard®
141-213 Meloxicam Metacam® Oral Suspension
141-219 Meloxicam Metacam® 5 mg/mL Solution for Injection
141-346 Meloxicam OroCAM® Transmucosal Oral Spray
200-485 Meloxicam Meloxicam Injection
200-491 Meloxicam Loxicom®
200-497 Meloxicam Loxicom®
200-540 Meloxicam Meloxicam Solution for Injection
200-550 Meloxicam Meloxidyl®
100-703 Mepivacaine Hydrochloride Carbocaine®-V Sterile Aqueous Solution
030-416 Methenamine Mandelate Mesulfin Tablets
141-292 Methimazole Felimazole®
038-838 Methocarbamol Robaxin®-V Injectable
045-715 Methocarbamol Robaxin®-V Tablets
011-403 Methylprednisolone Medrol® Tablets
011-700 Methylprednisolone Cortaba® Tablets
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:46
ApplicationNumber
Active Ingredients Trade Name
135-771 Methylprednisolone Methylprednisolene Tablets
012-204 Methylprednisolone Acetate Depo-Medrol®
136-212 Methylprednisolone Acetate Methylprednisolone Acetate Inj.
032-738 Metoserpate Hydrochloride Pacitran
102-709 Mibolerone Cheque® Drops
107-347 Mibolerone Cheque® Medicated Dog Food
095-183 Miconazole Nitrate Conofite® Cream 2%
095-184 Miconazole Nitrate Conofite® Lotion 1%
141-298 Miconazole Nitrate Surolan®
141-330 Miconazole Nitrate Easotic®
200-196 Miconazole Nitrate Miconosol
200-362 Miconazole Nitrate Priconazole™ Lotion 1% and Spray 1%
140-915 Milbemycin Oxime Interceptor™
141-084 Milbemycin Oxime Sentinel® Flavor Tabs®
141-163 Milbemycin Oxime Milbemite™ Otic Solution
141-204 Milbemycin Oxime Sentinel® Flavor Tabs® and Capstar® FleaManagement System™
141-321 Milbemycin Oxime Trifexis™
141-333 Milbemycin Oxime Sentinel® Spectrum®
141-338 Milbemycin Oxime INTERCEPTOR™ PLUS
200-629 Milbemycin Oxime MilbeGuard™
141-481 Mirtazapine Mirataz®
141-440 Mometasone furoate CLARO™
200-536 Mometasone furoate Mometavet®
141-177 Mometasone Furoate Monohydrate Mometamax™ Otic Suspension
141-266 Mometasone Furoate Monohydrate Posatex® Otic Suspension
047-933 Monensin Coban™ plus Baciferm®
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:47
ApplicationNumber
Active Ingredients Trade Name
095-735 Monensin Rumensin™ 90
104-646 Monensin Rumensin™ and Tylan™
118-509 Monensin Pasture Gainer Block 20 R350, Pasture GainerBlock 20 R350 No SE, Pasture Gainer Block 37R350, Pasture Gainer Block 37 R350 No SE
138-870 Monensin MGA® and Rumensin™ and Tylan™
140-955 Monensin Coban® / Flavomycin®
141-140 Monensin BMD® / Coban®
141-149 Monensin Deccox® and Rumensin™ and Tylan™
141-224 Monensin Optaflexx™ and Rumensin™ and Tylan™
141-233 Monensin Optaflexx™ and Rumensin™ and Tylan™andMGA®
141-276 Monensin Zilmax® and Rumensin™ and Tylan™
141-278 Monensin Zilmax® plus Rumensin®
141-282 Monensin Zilmax®/Rumensin®/MGA®
141-301 Monensin Topmax™ plus Coban®
141-343 Monensin Pulmotil® 90 and Rumensin® 90
141-430 Monensin Stafac® and Coban™
141-465 Monensin Inteprity™ and Coban™
141-491 Monensin Coban™ and LINCOMIX®
141-512 Monensin Experior™ and Rumensin™ and Tylan™
141-514 Monensin Experior™ and Rumensin™
141-540 Monensin Pennitracin MD® and Coban™
200-596 Monensin Tilmovet® 90 and Rumensin® 90
200-639 Monensin Monovet® 90
200-642 Monensin Monovet® and Tylovet®
200-643 Monensin Monovet® and Tylan™
200-644 Monensin Optaflexx™and Monovet® and Tylovet®
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:48
ApplicationNumber
Active Ingredients Trade Name
200-645 Monensin Actogain™ and Monovet® and Tylovet®
200-646 Monensin Optaflexx™and Monovet® and Tylan™
200-647 Monensin Actogain™ and Monovet® and Tylan™
200-648 Monensin Optaflexx™ and Monovet® and Tylovet® andMGA®
200-649 Monensin Actogain™ and Monovet® and Tylovet® andMGA®
200-650 Monensin Optaflexx™ and Monovet® and Tylan™ andMGA®
200-651 Monensin Actogain™ and Monovet® and Tylan™ andMGA®
200-652 Monensin Deccox® and Monovet®
200-653 Monensin Deccox® and Monovet® and Tylovet®
200-654 Monensin Tilmovet® and Monovet®
200-655 Monensin Pulmotil™ and Monovet®
200-656 Monensin Deccox® and Monovet® and Tylan™
200-658 Monensin MGA® and Monovet®
200-659 Monensin Actogain™ and Monovet® and MGA®
200-660 Monensin MGA® and Monovet® and Tylovet®
200-661 Monensin MGA® and Monovet® and Tylan™
200-662 Monensin Actogain™ and Monovet®
200-675 Monensin Optigrid® and Monovet®
200-676 Monensin Optigrid® and Monovet® and Tylovet®
200-677 Monensin Optigrid® and Monovet® and MGA®
200-678 Monensin Optigrid® and Monovet® and Tylovet® andMGA®
200-683 Monensin CycleGuard® and Monovet®
200-684 Monensin Optigrid® and Monovet® and CycleGuard®
200-685 Monensin CycleGuard® and Monovet® and Tylovet®
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:49
ApplicationNumber
Active Ingredients Trade Name
200-686 Monensin Optigrid® and Monovet® and Tylovet® andCycleGuard®
038-878 Monensin Sodium Coban™ 60, Coban™ 90
098-340 Monensin Sodium Flavomycin® / Monensin
099-006 Monensin Sodium Coban™/TM®
109-471 Monensin Sodium Sweetlix Rumensin® Pressed Block
119-253 Monensin Sodium Cattle Block M
121-553 Monensin Sodium Aureomycin® / Coban™
124-309 Monensin Sodium MGA® 100-200 / Rumensin®, MGA® 100-200Premix / Rumensin®
125-476 Monensin Sodium MGA® 500 plus Rumensin®
130-736 Monensin Sodium Coban™
134-830 Monensin Sodium Albac® / Coban®
138-456 Monensin Sodium Coban® / BMD®
140-937 Monensin Sodium BMD® / Coban®
141-148 Monensin Sodium Deccox® / Rumensin®
141-225 Monensin Sodium Optaflexx™ plus Rumensin®
141-234 Monensin Sodium Optaflexx™ / Rumensin® / MGA®
200-263 Monensin Sodium ChlorMax™ / Coban®
200-354 Monensin Sodium Pennchlor™ / Coban®
200-375 Monensin Sodium HeifermaX™ 500 / Rumensin™ / Tylan™
200-422 Monensin Sodium Heifermax 500 Liquid Premix and Rumensin®
200-424 Monensin Sodium Heifermax™ / Optaflexx® / Rumensin® / Tylan®
200-448 Monensin Sodium Heifermax 500®/Optaflexx®/Rumensin®
200-479 Monensin Sodium Heifermax® 500/Zilmax®/Rumensin®
200-480 Monensin Sodium Heifermax® 500/Zilmax®/Rumensin®/Tylan®
200-534 Monensin Sodium MGA®, Rumensin™ and Tylovet® 100
049-463 Monensin USP Coban™ plus BMD®
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:50
ApplicationNumber
Active Ingredients Trade Name
115-581 Monensin USP MoorMan's® Mintrate® Blonde Block RU,MoorMan's® Mintrate® Red Block RU
141-280 Monensin USP Zilmax® and Rumensin™ and Tylan™ andMGA®
200-531 Monensin USP Rumensin® plus Tylovet® 100
200-533 Monensin USP Deccox®, Rumensin™, and Tylovet® 100
200-544 Monensin USP Zilmax®/Rumensin®/Tylovet® 100/MGA®
200-547 Monensin USP Zilmax®/Rumensin®/Tylovet® 100
200-559 Monensin USP Actogain™ 45 plus Rumensin®
200-560 Monensin USP Actogain™ 45/Rumensin®/MGA®
200-561 Monensin USP Actogain™ 45/Rumensin®/Tylan®
200-562 Monensin USP Actogain™ 45/Rumensin®/Tylan®/MGA®
200-566 Monensin USP Optaflexx™ 45/Rumensin®/Tylovet® 100
200-567 Monensin USP Optaflexx™ 45/Rumensin®/Tylovet® 100/MGA®
200-583 Monensin USP Actogain™ 45/Rumensin®/Tylovet® 100/MGA®
200-585 Monensin USP Actogain™ 45/Rumensin®/Tylovet® 100
092-444 Morantel Tartrate Rumatel® 88
093-903 Morantel Tartrate Rumatel® Cattle Wormer Bolus
134-779 Morantel Tartrate Paratect Flex™
141-051 Moxidectin ProHeart™
141-087 Moxidectin Quest® Gel
141-099 Moxidectin Cydectin® (moxidectin) Pour-On for Beef andDairy Cattle
141-189 Moxidectin ProHeart® 6
141-216 Moxidectin Quest® Plus Gel
141-220 Moxidectin Cydectin®
141-247 Moxidectin Cydectin® Oral Drench for Sheep
141-251 Moxidectin Advantage Multi™ for Dogs
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:51
ApplicationNumber
Active Ingredients Trade Name
141-254 Moxidectin Advantage Multi® for Cats
141-417 Moxidectin CORAXIS™
141-518 Moxidectin BRAVECTO® PLUS
141-519 Moxidectin ProHeart® 12
141-521 Moxidectin Simparica Trio®
200-615 Moxidectin IMOXI™ Topical Solution for Dogs
200-638 Moxidectin IMOXI™ Topical Solution for Cats
200-700 Moxidectin PARASEDGE™ Multi for Dogs
200-701 Moxidectin PARASEDGE™ Multi for Cats
200-714 Moxidectin Barrier™ for cats
200-716 Moxidectin Midamox™ for Dogs
200-718 Moxidectin Barrier™ for dogs
200-721 Moxidectin Midamox™ for Cats
140-839 Mupirocin Bactoderm® Ointment
200-418 Mupirocin Muricin™
200-457 Mupirocin Mupirocin Ointment USP, 2%
046-746 N-butyl Chloride Happy Jack Worm Capsules
096-509 N-butyl Chloride NBC Kaps Wormer
141-228 N-Butylscopolammonium bromide Buscopan® Injectable Solution
010-424 Nalorphine Hydrochloride Nalline Hydrochloride
141-074 Naltrexone Hydrochloride Trexonil®
096-674 Naproxen Equiproxen Granules
096-675 Naproxen Equiproxen 10% Solution
118-980 Narasin Monteban™ 45
138-952 Narasin Maxiban™ 72
140-845 Narasin Flavomycin® / Monteban®
140-853 Narasin BMD® / Monteban®
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:52
ApplicationNumber
Active Ingredients Trade Name
140-865 Narasin Baciferm® / Albac®, Baciferm® / Monteban®
140-926 Narasin BMD® / Maxiban®
140-942 Narasin Flavomycin® / Maxiban®
141-124 Narasin BMD® / Maxiban®
141-340 Narasin Skycis™ 100
141-466 Narasin Inteprity™ and Maxiban™
141-467 Narasin Inteprity™ and Monteban™
141-529 Narasin Pennitracin MD® and Maxiban™
040-322 Neomycin Palmitate Kymar Ointment Improved
010-524 Neomycin Sulfate Neo-Cortef® with Tetracaine
011-315 Neomycin Sulfate Neomix® 325 Soluble Powder, Neomix® AG 325Soluble Powder
011-437 Neomycin Sulfate Hydeltrone Ointment
011-703 Neomycin Sulfate Neo-Delta-Cortef® with Tetracaine Ointment
011-953 Neomycin Sulfate Biosol® Sterile Solution, Biosol® Sterile Solution50 mg
012-258 Neomycin Sulfate Panolog® Ointment
013-181 Neomycin Sulfate Jenomycin Tablets
015-151 Neomycin Sulfate Neo-synalar Cream
015-433 Neomycin Sulfate Neo-Predef® with Tetracaine Powder
030-025 Neomycin Sulfate Neo-Predef® with Tetracaine Top. Ointment,Tritop® Topical Ointment
031-914 Neomycin Sulfate Neo-Darbazine Spansule Capsule No.1, Neo-Darbazine Spansule Capsule No.3
034-872 Neomycin Sulfate Neo Predef® Sterile Ointment
038-801 Neomycin Sulfate Anaprime® Ophthalmic Solution
042-633 Neomycin Sulfate Tresaderm Dermatologic Solution
049-725 Neomycin Sulfate Anaprime® Opthakote Ophthalmic
049-726 Neomycin Sulfate Optiprime® Opthakote Ophthalmic Solution
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:53
ApplicationNumber
Active Ingredients Trade Name
065-015 Neomycin Sulfate Bacitracin-Neomycin-Polymyxin withHydrocortisone Acetate Ophthalmic Ointment,Vetropolycin HC Ophthalmic Ointment
065-016 Neomycin Sulfate Bac-Neo-Poly Ophthalmic Ointment, VetropolycinOphthalmic Ointment
065-114 Neomycin Sulfate Mycitracin® Sterile Ophthalmic Ointment
065-119 Neomycin Sulfate Forte Topical® Ointment
065-476 Neomycin Sulfate Cortisporin Veterinary Ophthalmic Ointment
065-485 Neomycin Sulfate Neosporin Ophthalmic Ointment
091-534 Neomycin Sulfate Neo-Delta Cortef® Sterile Solution
093-514 Neomycin Sulfate Neo-Cortef® Sterile Ointment
094-975 Neomycin Sulfate Neo-Terramycin® 100/100, Neo-Terramycin®100/100D, Neo-Terramycin® 50/50, Neo-Terramycin® 50/50D
096-676 Neomycin Sulfate Panolog® Cream
138-939 Neomycin Sulfate Neo-Oxy 100/100 MR®, Neo-Oxy 50/50®
140-810 Neomycin Sulfate DERMA-VET® Ointment
140-847 Neomycin Sulfate Animax® Ointment
140-879 Neomycin Sulfate Derma 4 Ointment
140-976 Neomycin Sulfate Neomix Ag® 325 Medicated Premix, Neomix®325 Medicated Premix
141-003 Neomycin Sulfate Derm-Otic Ointment
200-046 Neomycin Sulfate Neomycin Sulfate
200-050 Neomycin Sulfate NeoMed® Soluble Powder
200-113 Neomycin Sulfate Biosol® Liquid
200-118 Neomycin Sulfate Neomycin Oral Solution
200-130 Neomycin Sulfate Neo-Sol® 50
200-153 Neomycin Sulfate Neo 200 Oral Solution
200-235 Neomycin Sulfate Neosol Soluble Powder
200-245 Neomycin Sulfate Derma-Vet Cream
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:54
ApplicationNumber
Active Ingredients Trade Name
200-289 Neomycin Sulfate Neosol-Oral
200-330 Neomycin Sulfate Animax® Cream
200-378 Neomycin Sulfate Neomycin Sulfate 325
200-379 Neomycin Sulfate Neomycin Liquid
200-553 Neomycin Sulfate Neomycin and Polymyxin B Sulfates, andBacitracin Zinc Ophthalmic Ointment
200-565 Neomycin Sulfate Thiabendazole, Dexamethasone, Neomycin SulfateSolution
008-097 Neostigmine Methylsulfate Stiglyn 1:500
009-476 Nicarbazin Nicarb® 25%
098-378 Nicarbazin Nicarbazin / Bacitracin Premix
135-468 Nicarbazin Carbigran 25, Nicarbazin
138-952 Nicarbazin Maxiban™ 72
140-339 Nicarbazin Nicarbazin (NICARB®) plus Bambermycins(FLAVOMYCIN®)
140-926 Nicarbazin BMD® / Maxiban®
140-942 Nicarbazin Flavomycin® / Maxiban®
141-124 Nicarbazin BMD® / Maxiban®
141-146 Nicarbazin Nicarb® / Baciferm®
141-279 Nicarbazin Nicarb® 25% plus BMD®
141-466 Nicarbazin Inteprity™ and Maxiban™
141-529 Nicarbazin Pennitracin MD® and Maxiban™
200-027 Nicarbazin Nicarmix 25®
200-164 Nicarbazin BMD® / Nicarmix 25®
200-478 Nicarbazin Albac® 50 plus Nicarb®
141-175 Nitenpyram CAPSTAR®
141-204 Nitenpyram Sentinel® Flavor Tabs® and Capstar® FleaManagement System™
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:55
ApplicationNumber
Active Ingredients Trade Name
141-205 Nitenpyram Program® Flavor Tabs® and Capstar® FleaManagement System™
011-154 Nitrofurazone NFZ® Puffer
100-854 Nitrofurazone Fura Ointment
122-447 Nitrofurazone Fura-Septin Soluble Dressing
125-797 Nitrofurazone Nitrofurazone Dressing
126-236 Nitrofurazone Nitrofurazone Soluble Powder
126-504 Nitrofurazone Nitrofurazone Ointment
130-872 Nitrofurazone Nitrofurazone Anesthetic Dress.
132-427 Nitrofurazone Fura-Zone
138-657 Nitrofurazone Nitrofurazone Ointment
140-851 Nitrofurazone NFZ® Wound Dressing
140-881 Nitrofurazone Nitrofurazone Soluble Dressing
200-425 Nitrofurazone Nitrofurazone Soluble Dressing
141-357 Nitrogen, NF None (Med Gas)
141-359 Nitrogen, NF None (Med Gas)
141-364 Nitrogen, NF None (Med Gas)
141-369 Nitrogen, NF None (Med Gas)
141-372 Nitrogen, NF None (Med Gas)
141-380 Nitrogen, NF None (Med Gas)
141-381 Nitrogen, NF None (Med Gas)
141-388 Nitrogen, NF None (Med Gas)
141-394 Nitrogen, NF None (Med Gas)
141-397 Nitrogen, NF None (Med Gas)
141-401 Nitrogen, NF None (Med Gas)
141-407 Nitrogen, NF None (Med Gas)
141-414 Nitrogen, NF None (Med Gas)
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:56
ApplicationNumber
Active Ingredients Trade Name
141-350 Nitrous Oxide, USP None (Med Gas)
141-411 Nitrous Oxide, USP None (Med Gas)
141-412 Nitrous Oxide, USP None (Med Gas)
141-446 Nitrous Oxide, USP None (Med Gas)
141-479 Nitrous Oxide, USP None (Med Gas)
134-930 Norgestomet Syncro-Mate-B®
012-375 Novobiocin Albamix® Feed Medication
055-072 Novobiocin Sodium Albacillin® Suspension, Special Formula 17900-Forte® Suspension
055-076 Novobiocin Sodium Albaplex® 3x Tablets, Albaplex® Tablets
055-098 Novobiocin Sodium Albadry Plus® Suspension
065-090 Novobiocin Sodium Delta Albaplex® 3x Tablets, Delta Albaplex®Tablets
065-099 Novobiocin Sodium Albaplex® Capsules
100-808 Novobiocin Sodium Albamast® Suspension
102-511 Novobiocin Sodium Biodry® Suspension, Drygard® Suspension
012-258 Nystatin Panolog® Ointment
012-680 Nystatin Pharmastatin®-20 Type A Medicated Article
096-676 Nystatin Panolog® Cream
140-810 Nystatin DERMA-VET® Ointment
140-847 Nystatin Animax® Ointment
140-879 Nystatin Derma 4 Ointment
141-003 Nystatin Derm-Otic Ointment
200-245 Nystatin Derma-Vet Cream
200-330 Nystatin Animax® Cream
141-345 Oclacitinib apoquel®
099-344 Oleate Sodium Osteum Solution 50 mg
141-123 Omeprazole GastroGard®
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:57
ApplicationNumber
Active Ingredients Trade Name
141-227 Omeprazole UlcerGard®
141-454 opAFP-GHc2 rDNA construct AquAdvantage Salmon
141-081 Orbifloxacin Orbax® Tablets
141-266 Orbifloxacin Posatex® Otic Suspension
141-305 Orbifloxacin Orbax®
040-209 Ormetoprim Rofenaid® 40
100-929 Ormetoprim Primor® Tablets
125-933 Ormetoprim Romet®-30
110-776 Oxfendazole Benzelmin® Powder For Suspension
110-777 Oxfendazole Benzelmin® Top Dress.
132-105 Oxfendazole Benzelmin® Equine Anthelmic Paste, Synanthic®Oral Paste
133-841 Oxfendazole Benzelmin® Equine Anthelmintic Suspension,Synanthic® Suspension
136-740 Oxfendazole Benzelmin® Plus Paste
140-854 Oxfendazole Synanthic® Bovine Dewormer Suspension 22.5%,Synanthic® Bovine Dewormer Suspension 9.06%
140-892 Oxfendazole Synanthic® Bovine Dewormer Paste, 18.5%
109-722 Oxibendazole Anthelcide EQ® Suspension
121-042 Oxibendazole Anthelcide EQ® Paste
136-483 Oxibendazole Filaribits® Plus Chewable Tablets
141-354 Oxygen, USP None (Med Gas)
141-358 Oxygen, USP None (Med Gas)
141-365 Oxygen, USP None (Med Gas)
141-373 Oxygen, USP None (Med Gas)
141-374 Oxygen, USP None (Med Gas)
141-375 Oxygen, USP None (Med Gas)
141-382 Oxygen, USP None (Med Gas)
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:58
ApplicationNumber
Active Ingredients Trade Name
141-387 Oxygen, USP None (Med Gas)
141-393 Oxygen, USP None (Med Gas)
141-396 Oxygen, USP None (Med Gas)
141-398 Oxygen, USP None (Med Gas)
141-399 Oxygen, USP None (Med Gas)
141-408 Oxygen, USP None (Med Gas)
141-413 Oxygen, USP None (Med Gas)
141-486 Oxygen, USP None (Med Gas)
046-718 Oxytetracycline MGA® (liquid) and TM®
046-719 Oxytetracycline MGA® and TM®
094-975 Oxytetracycline Neo-Terramycin® 100/100, Neo-Terramycin®100/100D, Neo-Terramycin® 50/50, Neo-Terramycin® 50/50D
095-143 Oxytetracycline Terramycin® 10, Terramycin® 30, Terramycin®50, Terramycin® 100, Terramycin® 200,Terramycin® 200 Granular, Terramycin® 100MR
099-006 Oxytetracycline Coban™/TM®
101-666 Oxytetracycline TM® plus Robenz®
113-232 Oxytetracycline Liquamycin® LA-200®, Liquamycin® LA-200®(Rx)
118-123 Oxytetracycline Compudose™ 200, Encore™ (Compudose 400™ )
138-938 Oxytetracycline Pennox 50®, Pennox 100-MR®, Pennox 100 Hi-Flo®, Pennox 200 Hi-Flo®
140-448 Oxytetracycline TM® plus Bio-Cox®
141-211 Oxytetracycline Mecadox® and Terramycin®
141-312 Oxytetracycline Hexasol® Injection
200-008 Oxytetracycline Bio-Mycin® 200 , Oxy-Tet® 200 InjectableSolution
200-096 Oxytetracycline Sacox® / Terramycin®
200-117 Oxytetracycline Oxytetracycline Injection, OxytetracyclineInjection
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:59
ApplicationNumber
Active Ingredients Trade Name
200-123 Oxytetracycline Maxim-200® Injection, OxytetracyclineHydrochloride Injection 200mg
200-154 Oxytetracycline Oxytetracycline 200, Pennox™ 200
200-306 Oxytetracycline Oxytetracycline Injection 200
200-537 Oxytetracycline Tetroxy®-LA
140-579 Oxytetracycline (Monoalkyl TrimethylAmmonium Salt)
BOVATEC® and TM®
038-439 Oxytetracycline Dihydrate Terramycin® 100 for Fish, Terramycin® 200 forFish
141-143 Oxytetracycline Dihydrate Noromycin® 300 LA, TETRADURE™ 300
200-128 Oxytetracycline Dihydrate Agrimycin® - 200
007-879 Oxytetracycline Hydrochloride Terramycin® Vet Capsules
008-622 Oxytetracycline Hydrochloride TERRAMYCIN-343®, TERRAMYCIN®,TERRAMYCIN® Soluble Powder Concentrate
008-763 Oxytetracycline Hydrochloride Terramycin® Ophthalmic Ointment withPolymyxin
008-769 Oxytetracycline Hydrochloride Liquamycin® Injectable, Terramycin® Injectable
008-804 Oxytetracycline Hydrochloride TM-50® , TM-50® D , TM-100® , TM-100®D
011-060 Oxytetracycline Hydrochloride Terramycin® Scours Tablets
013-146 Oxytetracycline Hydrochloride Liquamycin® Intramuscular
013-293 Oxytetracycline Hydrochloride Liqua-Cortril Spray, Terra-Cortril Spray
032-946 Oxytetracycline Hydrochloride MAGNA-TERRAMYCIN® Soluble Powder
038-200 Oxytetracycline Hydrochloride OXY WS™
045-143 Oxytetracycline Hydrochloride Oxyject®
047-278 Oxytetracycline Hydrochloride Bio-Mycin®, Oxy-Tet™ 50
048-287 Oxytetracycline Hydrochloride Oxytetracycline-50
049-948 Oxytetracycline Hydrochloride Aquachel 100 mg
091-127 Oxytetracycline Hydrochloride Rachelle Oxyvet Injection
094-114 Oxytetracycline Hydrochloride Liquamycin® 100, Terramycin® 100
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:60
ApplicationNumber
Active Ingredients Trade Name
095-642 Oxytetracycline Hydrochloride Bio-Mycin C, Oxy-Tet™ Injection
097-452 Oxytetracycline Hydrochloride Oxyject® 100
099-402 Oxytetracycline Hydrochloride Aquachel-100, Oxyvet-100
108-963 Oxytetracycline Hydrochloride Medamycin® Injectable
130-435 Oxytetracycline Hydrochloride OXYMarine™, Oxytet® Soluble
138-939 Oxytetracycline Hydrochloride Neo-Oxy 100/100 MR®, Neo-Oxy 50/50®
140-582 Oxytetracycline Hydrochloride Oxytetracycline Hydrochloride Injection
141-002 Oxytetracycline Hydrochloride OXY 1000 Calf Bolus, OXY 500 Calf Bolus
200-026 Oxytetracycline Hydrochloride Pennox 343®
200-066 Oxytetracycline Hydrochloride AGRIMYCIN®-343
200-068 Oxytetracycline Hydrochloride Oxytetracycline Hydrochloride Injection
200-144 Oxytetracycline Hydrochloride Tetroxy® HCA-280, Tetroxy® HCA-1772,Tetroxy® HCA-1400
200-146 Oxytetracycline Hydrochloride Tetroxy® 25
200-247 Oxytetracycline Hydrochloride Tetroxy® 343
200-452 Oxytetracycline Hydrochloride Oxytet 100
200-460 Oxytetracycline Hydrochloride Tetroxy® Aquatic
046-788 Oxytocin Oxytocin Injection
099-169 Oxytocin Oxytocin (Label Under Distributors)
109-305 Oxytocin Oxytocin Injectable
124-241 Oxytocin PVL Oxytocin Injectable
130-136 Oxytocin Oxytocin Injection
200-328 Oxytocin Oxytocin Injection
141-392 Pegbovigrastim Imrestor™
065-087 Penicillin G Benzathine Longicil Fortified
065-169 Penicillin G Benzathine Dura-biotic, Flo-cillin®
065-498 Penicillin G Benzathine Dual-Cillin™, Pen BP-48
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:61
ApplicationNumber
Active Ingredients Trade Name
065-506 Penicillin G Benzathine Combi-PEN-48®
055-060 Penicillin G Potassium Penicillin G Potassium, USP
065-276 Penicillin G Potassium Veesyn Granules for Oral Soln
200-103 Penicillin G Potassium PenAqua Sol-G®, Penicillin G Potassium, USP
200-106 Penicillin G Potassium R-Pen
200-122 Penicillin G Potassium Solu-Pen
200-347 Penicillin G Potassium Penicillin G Potassium USP
200-372 Penicillin G Potassium Han-Pen™
055-028 Penicillin G Procaine Quartermaster® Suspension
055-072 Penicillin G Procaine Albacillin® Suspension, Special Formula 17900-Forte® Suspension
055-097 Penicillin G Procaine Dry-Mast
055-098 Penicillin G Procaine Albadry Plus® Suspension
065-010 Penicillin G Procaine Norocillin
065-081 Penicillin G Procaine Go-Dry™, Masti-Clear®
065-087 Penicillin G Procaine Longicil Fortified
065-110 Penicillin G Procaine PEN-G-MAX®
065-119 Penicillin G Procaine Forte Topical® Ointment
065-130 Penicillin G Procaine Crystalline Pro Penicillin G
065-169 Penicillin G Procaine Dura-biotic, Flo-cillin®
065-174 Penicillin G Procaine Crysticillin
065-383 Penicillin G Procaine Formula A-34, Uni Biotic 4 Dose
065-498 Penicillin G Procaine Dual-Cillin™, Pen BP-48
065-505 Penicillin G Procaine Pro-Pen-G®
065-506 Penicillin G Procaine Combi-PEN-48®
065-275 Penicillin V Potassium Penicillin VK Filmtab 250 mg
044-611 Pentazocine Lactate Talwin®-V Sterile Aqueous Injection
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
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ApplicationNumber
Active Ingredients Trade Name
046-789 Pentobarbital Chloropent
004-536 Pentobarbital Sodium Somnopentyl Injection
010-346 Pentobarbital Sodium Combuthal Powder
119-807 Pentobarbital Sodium Beuthanasia-D Special
200-071 Pentobarbital Sodium Euthasol®
200-280 Pentobarbital Sodium Euthanasia-III Solution
200-614 Pentobarbital Sodium Pentobarbital Sodium and Phenytoin Sodium
141-331 Pergolide mesylate Prascend®
015-154 Phenothiazine Dyrex T.F - 1000, Dyrex T.F - 200, Dyrex T.F -500
033-149 Phenothiazine Parvex Plus® Suspension
010-987 Phenylbutazone Butazolidin® Bolus, Butazolidin® Tablets
011-575 Phenylbutazone Butazolidin® Injectable 20%
038-800 Phenylbutazone Butazolidin® Granules
044-756 Phenylbutazone Butatron®
045-416 Phenylbutazone Tevcodyne Injectable
045-514 Phenylbutazone EquiBute Injection
045-515 Phenylbutazone EquiBute Tablets 100 mg
046-780 Phenylbutazone Phen-Buta Vet Injection
047-712 Phenylbutazone Bizolin®-100, Bizolin®-200
049-187 Phenylbutazone Phen-Buta Vet Tablets, Phenylbutazone Tablets(Horses)
091-065 Phenylbutazone Robizone-V
091-818 Phenylbutazone Phenylbutazone Tablets, USP 1 gram
093-105 Phenylbutazone Robizone-V
093-516 Phenylbutazone Bizolin Injection 20%
094-170 Phenylbutazone Phenylbutazone Tablets, USP 100 mg,Phenylbutazone Tablets, USP 200 mg
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
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ApplicationNumber
Active Ingredients Trade Name
096-671 Phenylbutazone Phen-Buta-Vet Injection
096-672 Phenylbutazone Phen-Buta-Vet Tablets, Phenylbutazone S/A
098-640 Phenylbutazone Robizone Injectable 20%
099-618 Phenylbutazone Bizolin® 1-G
113-510 Phenylbutazone Equipalazone
116-087 Phenylbutazone Butazolidin®, Butazolidin® Paste, Bute,Phenylbute™ Paste, Phenylzone® Paste
118-979 Phenylbutazone Butatron Gel
200-126 Phenylbutazone Phenylbutazone 20% Injection
200-266 Phenylbutazone Butequine™
200-333 Phenylbutazone Superiorbute®
200-334 Phenylbutazone Equizone 100™
200-371 Phenylbutazone Phenylbutazone 20% Injection
200-433 Phenylbutazone Pributazone®
141-324 Phenylpropanolamine hydrochloride PROIN® Chewable Tablets
141-517 Phenylpropanolamine hydrochloride PROIN ER™
119-807 Phenytoin Sodium Beuthanasia-D Special
200-071 Phenytoin Sodium Euthasol®
200-280 Phenytoin Sodium Euthanasia-III Solution
200-614 Phenytoin Sodium Pentobarbital Sodium and Phenytoin Sodium
044-757 Phosmet Prolate I-E
141-273 Pimobendan Vetmedin®
012-469 Piperazine Citrate Dizan Suspension With Piperazine
047-333 Piperazine Citrate Equizole® A Liquid
092-709 Piperazine Citrate Sergeants® Worm Away For Dogs
092-710 Piperazine Citrate Sergeants® Worm Away For Cats
015-154 Piperazine Dihydrochloride Dyrex T.F - 1000, Dyrex T.F - 200, Dyrex T.F -500
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:64
ApplicationNumber
Active Ingredients Trade Name
092-237 Piperazine Dihydrochloride Ripercol L-Piperazine Soluble
093-688 Piperazine Dihydrochloride Ripercol L-Piperazine
125-730 Piperazine Monohydrochloride Purina® Liquid Dog Wormer
037-410 Piperazine Phosphate Equizole® A
101-161 Piperazine Phosphate Thenatol PW Tablets
011-299 Piperazine-carbon Disulfide Complex Parvex® Suspension
011-590 Piperazine-carbon Disulfide Complex Parvex® Bolus
033-149 Piperazine-carbon Disulfide Complex Parvex Plus® Suspension
141-036 Pirlimycin Hydrochloride Pirsue® Sterile Solution
009-167 Pituitary Luteinizing Hormone P.L.H. Injectable
032-704 Poloxalene Bloat Guard Top Dressing
033-760 Poloxalene Bloat Guard Drench Concentrate
033-773 Poloxalene Sweetlix® Bloat Guard® Pressed Block
038-281 Poloxalene Bloat Guard®
039-729 Poloxalene Therabloat®
008-763 Polymyxin B Sulfate Terramycin® Ophthalmic Ointment withPolymyxin
038-801 Polymyxin B Sulfate Anaprime® Ophthalmic Solution
049-725 Polymyxin B Sulfate Anaprime® Opthakote Ophthalmic
049-726 Polymyxin B Sulfate Optiprime® Opthakote Ophthalmic Solution
065-015 Polymyxin B Sulfate Bacitracin-Neomycin-Polymyxin withHydrocortisone Acetate Ophthalmic Ointment,Vetropolycin HC Ophthalmic Ointment
065-016 Polymyxin B Sulfate Bac-Neo-Poly Ophthalmic Ointment, VetropolycinOphthalmic Ointment
065-114 Polymyxin B Sulfate Mycitracin® Sterile Ophthalmic Ointment
065-119 Polymyxin B Sulfate Forte Topical® Ointment
065-476 Polymyxin B Sulfate Cortisporin Veterinary Ophthalmic Ointment
065-485 Polymyxin B Sulfate Neosporin Ophthalmic Ointment
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
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ApplicationNumber
Active Ingredients Trade Name
141-298 Polymyxin B Sulfate Surolan®
200-553 Polymyxin B Sulfate Neomycin and Polymyxin B Sulfates, andBacitracin Zinc Ophthalmic Ointment
136-214 Polyoxyethylene 23 Lauryl Ether Enproal Bloat Blox
136-383 Polysulfated Glycosaminoglycan Adequan® Injectable
140-901 Polysulfated Glycosaminoglycan Adequan® i.m., Adequan® i.m. Multi-Dose
141-038 Polysulfated Glycosaminoglycan Adequan® Canine
141-188 Ponazuril Marquis® Antiprotozoal Oral Paste
141-236 Porcine insulin zinc suspension Vetsulin®
141-431 Porcine pituitary-derived folliclestimulating hormone
FOLLTROPIN®
141-266 posaconazole Posatex® Otic Suspension
141-544 Potassium bromide KBroVet®-CA1
125-961 Potassium Citrate Re-Sorb, Vytrate
125-961 Potassium Phosphate Re-Sorb, Vytrate
141-542 pPL657 rDNA construct pPL657 rDNA CONSTRUCT IN DOMESTICPIGS
141-344 Pradofloxacin Veraflox™
039-204 Pralidoxime Chloride Protopam
111-607 Praziquantel Droncit® 5.68% Injectible Solution
111-798 Praziquantel Droncit® Canine Cestocide Tablets, Droncit®Feline Cestocide Tablets, Praziquantel 34 (Rx),Tapeworm Dewormer for Cats (OTC), TapewormDewormer for Dogs (OTC)
133-953 Praziquantel Vercom Paste Anthelmintic
141-007 Praziquantel Drontal® Plus, Drontal® Plus Taste Tabs®, QuadDewormer
141-008 Praziquantel Drontal™ Tablets
141-214 Praziquantel ZIMECTERIN® Gold Paste
141-215 Praziquantel Equimax®
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
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ApplicationNumber
Active Ingredients Trade Name
141-216 Praziquantel Quest® Plus Gel
141-257 Praziquantel Iverhart Max®
141-261 Praziquantel Sentry® HC Worm X Plus®
141-275 Praziquantel Profender™
141-286 Praziquantel Panacur® Plus
141-333 Praziquantel Sentinel® Spectrum®
141-338 Praziquantel INTERCEPTOR™ PLUS
141-421 Praziquantel Duocare™
141-441 Praziquantel IVERHART MAX® Chew
141-492 Praziquantel Centragard®
200-176 Praziquantel Prazitech™
200-265 Praziquantel Prazi-C Tablets (OTC), Praziquantel Tablets (Rx)
200-501 Praziquantel Praziquantel Injection
012-437 Prednisolone Temaril-P® Tablets
035-161 Prednisolone Temaril-P® Spansule Capsule No. 1, Temaril-P®Spansule Capsule No. 2
065-090 Prednisolone Delta Albaplex® 3x Tablets, Delta Albaplex®Tablets
140-921 Prednisolone PrednisTab®
010-312 Prednisolone Acetate Meticortelone Acetate
011-703 Prednisolone Acetate Neo-Delta-Cortef® with Tetracaine Ointment
091-534 Prednisolone Acetate Neo-Delta Cortef® Sterile Solution
141-298 Prednisolone Acetate Surolan®
011-437 Prednisolone Sodium Phosphate Hydeltrone Ointment
098-288 Prednisolone Sodium Phosphate Prednis-A-Vet Injection
011-593 Prednisolone Sodium Succinate Solu-Delta Cortef® Sterile Powder
011-080 Prednisolone Tertiary Butylacetate Hydeltrone-TBA Suspension
009-963 Prednisone Meticorten®
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
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ApplicationNumber
Active Ingredients Trade Name
009-392 Primidone Primidone
010-091 Primidone Mylepsin Tablets
030-137 Primidone Mylepsin, Primidone Medi-Pets
117-689 Primidone Neurosyn Tablets
031-914 Prochlorperazine Dimaleate Neo-Darbazine Spansule Capsule No.1, Neo-Darbazine Spansule Capsule No.3
015-147 Prochlorperazine Edisylate Darbazine Injectable
013-201 Prochlorperazine Maleate Darbazine Spansule Capsule No.1
009-576 Progesterone Synovex® C, Synovex® S
110-315 Progesterone Component™ E-C with Tylan™, Component™ E-S with Tylan™
141-200 Progesterone EAZI-BREED™ CIDR® Cattle Insert
141-302 Progesterone EAZI-BREED™ CIDR® Sheep Insert
011-241 Promazine Hydrochloride Promazine HCl Injectable
012-656 Promazine Hydrochloride Promazine Granules
092-116 Promazine Hydrochloride Ketaset® Plus
119-141 Promazine Hydrochloride Tranquazine Injection
009-035 Proparacaine Hydrochloride Ophthaine® Solution
041-665 Propiopromazine Hydrochloride Tranvet Chewable Tablets (20 mg)
045-716 Propiopromazine Hydrochloride Tranvet Injectable Solution
141-070 Propofol Rapanofal®
141-098 Propofol PropoFlo™, PropoFlo™ 28
141-303 Propofol PropoClear™
100-254 Prostalene Synchrocept Solution
091-739 Pyrantel Pamoate Strongid® T
100-237 Pyrantel Pamoate Nemex, Nemex-2, RFD Liquid Wormer
101-331 Pyrantel Pamoate Dog Wormer Tablets
129-831 Pyrantel Pamoate Banminth®-P Paste, Strongid® Paste
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
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ApplicationNumber
Active Ingredients Trade Name
139-191 Pyrantel Pamoate Adams™, D-Worm™, Dog Wormer ChewableTablets
140-971 Pyrantel Pamoate Heartgard® Plus
141-007 Pyrantel Pamoate Drontal® Plus, Drontal® Plus Taste Tabs®, QuadDewormer
141-008 Pyrantel Pamoate Drontal™ Tablets
141-257 Pyrantel Pamoate Iverhart Max®
141-261 Pyrantel Pamoate Sentry® HC Worm X Plus®
141-441 Pyrantel Pamoate IVERHART MAX® Chew
141-521 Pyrantel Pamoate Simparica Trio®
200-007 Pyrantel Pamoate Liqui-Vict 2X™
200-246 Pyrantel Pamoate Anthelban V
200-248 Pyrantel Pamoate Pyrantel Pamoate Suspension, PyrantelPamoate Suspension-2.27mg, Pyrantel PamoateSuspension-4.54mg
200-281 Pyrantel Pamoate Pyrantel Pamoate Chewable Tablets
200-302 Pyrantel Pamoate Iverhart™ Plus Flavored Chewables
200-338 Pyrantel Pamoate Tri-Heart Plus Chewable Tablets
200-342 Pyrantel Pamoate Pyrantel Pamoate Paste
200-350 Pyrantel Pamoate Exodus™ Paste, Exodus® Multi Dose
200-352 Pyrantel Pamoate Primex® 2-X, Primex® Canine
200-353 Pyrantel Pamoate Primex™ Equine
200-445 Pyrantel Pamoate Primex®
042-888 Pyrantel Tartrate Banminth®, Strongid®
043-290 Pyrantel Tartrate Banminth® 48
092-150 Pyrantel Tartrate Purina® Horse & Colt Wormer
092-955 Pyrantel Tartrate Banminth® / Mecadox®
110-047 Pyrantel Tartrate Tylan™ and Banminth®
116-044 Pyrantel Tartrate LINCOMIX® and Banminth®
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
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ApplicationNumber
Active Ingredients Trade Name
118-877 Pyrantel Tartrate Ban-A-Worm Py. Tartrate, Ban-A-Worm PyrantelTartrate Ton Pack
138-941 Pyrantel Tartrate LINCOMIX® and Banminth®
140-819 Pyrantel Tartrate Strongid® 48
200-168 Pyrantel Tartrate PyrantelCare™
200-282 Pyrantel Tartrate Continuex™
046-288 Pyrilamine Maleate Histavet-P®
138-405 Pyrilamine Maleate Pyrilamine Maleate Injection
141-240 Pyrimethamine ReBalance®
141-545 Rabacfosadine TANOVEA™
140-863 Ractopamine Hydrochloride Paylean® 45, Paylean® 9
141-172 Ractopamine Hydrochloride Paylean™/Tylan™
141-221 Ractopamine Hydrochloride Optaflexx® 45
141-224 Ractopamine Hydrochloride Optaflexx™ and Rumensin™ and Tylan™
141-225 Ractopamine Hydrochloride Optaflexx™ plus Rumensin®
141-233 Ractopamine Hydrochloride Optaflexx™ and Rumensin™ and Tylan™andMGA®
141-234 Ractopamine Hydrochloride Optaflexx™ / Rumensin® / MGA®
141-290 Ractopamine Hydrochloride Topmax™ 9
141-301 Ractopamine Hydrochloride Topmax™ plus Coban®
200-424 Ractopamine Hydrochloride Heifermax™ / Optaflexx® / Rumensin® / Tylan®
200-448 Ractopamine Hydrochloride Heifermax 500®/Optaflexx®/Rumensin®
200-530 Ractopamine Hydrochloride Paylean® plus Tylovet®
200-542 Ractopamine Hydrochloride Engain™ 9 and Engain™ 45
200-548 Ractopamine Hydrochloride Actogain™ 45
200-558 Ractopamine Hydrochloride Engain™ plus Tylan®
200-559 Ractopamine Hydrochloride Actogain™ 45 plus Rumensin®
200-560 Ractopamine Hydrochloride Actogain™ 45/Rumensin®/MGA®
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
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ApplicationNumber
Active Ingredients Trade Name
200-561 Ractopamine Hydrochloride Actogain™ 45/Rumensin®/Tylan®
200-562 Ractopamine Hydrochloride Actogain™ 45/Rumensin®/Tylan®/MGA®
200-566 Ractopamine Hydrochloride Optaflexx™ 45/Rumensin®/Tylovet® 100
200-567 Ractopamine Hydrochloride Optaflexx™ 45/Rumensin®/Tylovet® 100/MGA®
200-583 Ractopamine Hydrochloride Actogain™ 45/Rumensin®/Tylovet® 100/MGA®
200-584 Ractopamine Hydrochloride Engain™ plus Tylovet® 100
200-585 Ractopamine Hydrochloride Actogain™ 45/Rumensin®/Tylovet® 100
200-644 Ractopamine Hydrochloride Optaflexx™and Monovet® and Tylovet®
200-645 Ractopamine Hydrochloride Actogain™ and Monovet® and Tylovet®
200-646 Ractopamine Hydrochloride Optaflexx™and Monovet® and Tylan™
200-647 Ractopamine Hydrochloride Actogain™ and Monovet® and Tylan™
200-648 Ractopamine Hydrochloride Optaflexx™ and Monovet® and Tylovet® andMGA®
200-649 Ractopamine Hydrochloride Actogain™ and Monovet® and Tylovet® andMGA®
200-650 Ractopamine Hydrochloride Optaflexx™ and Monovet® and Tylan™ andMGA®
200-651 Ractopamine Hydrochloride Actogain™ and Monovet® and Tylan™ andMGA®
200-659 Ractopamine Hydrochloride Actogain™ and Monovet® and MGA®
200-662 Ractopamine Hydrochloride Actogain™ and Monovet®
200-675 Ractopamine Hydrochloride Optigrid® and Monovet®
200-676 Ractopamine Hydrochloride Optigrid® and Monovet® and Tylovet®
200-677 Ractopamine Hydrochloride Optigrid® and Monovet® and MGA®
200-678 Ractopamine Hydrochloride Optigrid® and Monovet® and Tylovet® andMGA®
200-679 Ractopamine Hydrochloride Optigrid® 45
200-684 Ractopamine Hydrochloride Optigrid® and Monovet® and CycleGuard®
200-686 Ractopamine Hydrochloride Optigrid® and Monovet® and Tylovet® andCycleGuard®
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:71
ApplicationNumber
Active Ingredients Trade Name
200-691 Ractopamine Hydrochloride RAC™ 45 CATTLE
141-320 Robenacoxib onsior® Tablets for Cats
141-443 Robenacoxib onsior® injection
141-463 Robenacoxib onsior™
048-486 Robenidine Hydrochloride Robenz®
092-507 Robenidine Hydrochloride Robenz® and Aureomycin®
096-933 Robenidine Hydrochloride Robenz® Plus Zn Bacitracin
097-085 Robenidine Hydrochloride Bac MD / Robenz®
101-666 Robenidine Hydrochloride TM® plus Robenz®
141-154 Robenidine Hydrochloride BMD® / Robenz®
141-482 Robenidine Hydrochloride Robenz® and LINCOMIX®
200-212 Robenidine Hydrochloride Albac® / Robenz®
141-229 Romifidine hydrochloride Sedivet®
141-534 Ropinirole CLEVOR®
128-686 Salinomycin Sodium Bio-Cox® Type A Medicated Article
134-284 Salinomycin Sodium Bio-Cox® / Flavomycin®
135-746 Salinomycin Sodium Bio-Cox® / BMD®
139-235 Salinomycin Sodium Baciferm® / Bio-Cox®
140-448 Salinomycin Sodium TM® plus Bio-Cox®
140-859 Salinomycin Sodium Bio-Cox®/Aureomycin®
141-136 Salinomycin Sodium Bio-Cox® / BMD®
141-468 Salinomycin Sodium Stafac® and Bio-Cox®
141-484 Salinomycin Sodium Bio-Cox® and LINCOMIX®
141-495 Salinomycin Sodium Inteprity™ and Bio-Cox®
200-075 Salinomycin Sodium Sacox® 60
200-082 Salinomycin Sodium BMD® / Sacox®
200-083 Salinomycin Sodium Flavomycin® / Sacox®
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:72
ApplicationNumber
Active Ingredients Trade Name
200-089 Salinomycin Sodium Baciferm® / Sacox®
200-095 Salinomycin Sodium Aureomycin® / Sacox®
200-096 Salinomycin Sodium Sacox® / Terramycin®
200-204 Salinomycin Sodium Albac® / Bio-Cox®
200-210 Salinomycin Sodium Albac® / Sacox®
200-261 Salinomycin Sodium Bio-Cox® / ChlorMax™
200-262 Salinomycin Sodium ChlorMax® / Sacox®
200-357 Salinomycin Sodium Pennchlor® / Bio-Cox®
200-528 Salinomycin Sodium Savalan® 60
141-452 Sarolaner Simparica®
141-502 Sarolaner revolution® PLUS
141-521 Sarolaner Simparica Trio®
128-967 Secobarbital Sodium Repose Euthanasia Solution
141-152 Selamectin Revolution®
141-502 Selamectin revolution® PLUS
200-663 Selamectin Selarid™
200-670 Selamectin SENERGY™
200-673 Selamectin Revolt®
200-696 Selamectin SelaSpot™
141-080 Selegiline Hydrochloride Anipryl®
008-422 Selenium Disulfide Seleen® Suspension
111-349 Selenium Disulfide SE S2 Shampoo
115-579 Selenium Disulfide Dandrex
140-940 Semduramicin Sodium Aviax™ Premix for Broiler Chickens
141-065 Semduramicin Sodium Aviax™ / BMD®
141-114 Semduramicin Sodium Aviax® and Stafac®
141-281 Semduramicin Sodium Aviax® II
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:73
ApplicationNumber
Active Ingredients Trade Name
141-289 Semduramicin Sodium Aviax II® plus Stafac®
140-856 Serum Gonadotropin P.G. 600®
141-103 Sevoflurane SevoFlo®
200-438 Sevoflurane Petrem®
200-467 Sevoflurane Sevoflurane
141-176 Silver sulfadiazine Baytril® Otic
006-281 Sodium Chloride Intragel
125-961 Sodium Chloride Re-Sorb, Vytrate
012-635 Sodium Selenite BO-SE
030-313 Sodium Selenite Seletoc® Minicaps and Caps
030-314 Sodium Selenite Mu-Se
030-315 Sodium Selenite E-SE
030-316 Sodium Selenite Seletoc® Injection
200-109 Sodium Selenite Velenium™
015-160 Sodium SulfachloropyrazineMonohydrate
SODIUM SULFACHLOROPYRAZINE(MONOHYDRATE) SOLUTION, SODIUMSULFACHOROPYRAZINE (MONOHYDRATE)SOLUBLE POWDER
031-553 Sodium SulfachloropyrazineMonohydrate
ESB 3 Soluble Powder, ESB 3 Solution
033-373 Sodium sulfachlorpyridazine Vetisulid®
122-272 Sodium sulfamethazine Sulmet® Soluble Powder
200-434 Sodium sulfamethazine SMZ-Med® 454
038-661 Spectinomycin SpectoGard® Water Soluble Powder
200-345 Spectinomycin dihydrochloridepentahydrate
Lincomycin - Spectinomycin
200-364 Spectinomycin dihydrochloridepentahydrate
Spectogard Scour-Chek™
200-380 Spectinomycin dihydrochloridepentahydrate
SpecLinx-50®
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:74
ApplicationNumber
Active Ingredients Trade Name
200-407 Spectinomycin dihydrochloridepentahydrate
Lincomycin-Spectinomycin Water Soluble Powder
015-126 Spectinomycin HydrochloridePentahydrate
Spectinomycin Tablet and Injection
033-157 Spectinomycin HydrochloridePentahydrate
Spectam® Scour Halt®
040-040 Spectinomycin HydrochloridePentahydrate
Spectam® Injectable
041-629 Spectinomycin HydrochloridePentahydrate
Spectinomycin Oral Liquid
093-483 Spectinomycin HydrochloridePentahydrate
Spectam® Injectable
093-515 Spectinomycin HydrochloridePentahydrate
Spectam® Tablets
200-127 Spectinomycin HydrochloridePentahydrate
PROSPEC® Injectable, Spectinomycin Injectable
046-109 Spectinomycin Sulfate Tetrahydrate L-S 50 Water Soluble® Powder
141-077 Spectinomycin Sulfate Tetrahydrate Adspec® Sterile Solution
141-277 Spinosad Comfortis®
141-321 Spinosad Trifexis™
141-538 Spironolactone Cardalis™
015-506 Stanozolol Winstrol-V® Tablets
030-844 Stanozolol Winstrol-V® Sterile Suspension
135-544 Stanozolol Winstrol-V® Chewable Tablets
065-107 Streptomycin Sulfate Entromycin Powder
065-252 Streptomycin Sulfate STREP SOL®
200-197 Streptomycin Sulfate Streptomycin Oral Solution
011-532 Sulfabromomethazine Sodium Sulfabrom 2.5 g
033-127 Sulfachlorpyridazine Prinzone Bolus, Pyradan Bolus, Vetisulid® Bolus
033-318 Sulfachlorpyridazine Prinzone Injection, Pyradan Injection, Vetisulid®Injection
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:75
ApplicationNumber
Active Ingredients Trade Name
033-319 Sulfachlorpyridazine Vetisulid® Tablets
040-181 Sulfachlorpyridazine Vetisulid® Oral Suspension
095-614 Sulfadiazine Tribrissen® 120 Tablets, Tribrissen® 30 Tablets,Tribrissen® 480 Tablets, Tribrissen® 960 Tablets
106-965 Sulfadiazine Tribrissen® 48% Injection
115-578 Sulfadiazine Di-Trim® Tablets
131-918 Sulfadiazine Tribrissen® 400 Oral Paste
132-486 Sulfadiazine Di-Trim® 24%
134-778 Sulfadiazine Di-Trim® 48% Injection
136-342 Sulfadiazine Di-Trim® 400 Paste
136-741 Sulfadiazine Tribrissen® 60 Oral Suspension
141-360 Sulfadiazine EQUISUL-SDT®
200-033 Sulfadiazine Uniprim™ Powder
200-244 Sulfadiazine Tucoprim® Powder
105-093 Sulfadiazine Sodium Tribrissen® 24% Injection
141-240 Sulfadiazine Sodium ReBalance®
012-087 Sulfadimethoxine Bactrovet Tablets 250 mg
015-102 Sulfadimethoxine Albon® Tablets
031-205 Sulfadimethoxine AGRIBON® Concentrated Solution 12.5%,ALBON® Concentrated Solution 12.5%
031-715 Sulfadimethoxine Albon®, Agribon Boluses - 2.5, Agribon Boluses -5.0, Agribon Boluses - 15.0
037-700 Sulfadimethoxine Bactrovet Oral Suspension 12.5%
040-209 Sulfadimethoxine Rofenaid® 40
041-245 Sulfadimethoxine Agribon Injection 40%, Albon®
043-785 Sulfadimethoxine Albon Oral Suspension 5%
046-285 Sulfadimethoxine Albon®
093-107 Sulfadimethoxine Albon® S.R. (Sustained Release)
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:76
ApplicationNumber
Active Ingredients Trade Name
098-569 Sulfadimethoxine Medacide-SDM Injection 10%
100-929 Sulfadimethoxine Primor® Tablets
125-933 Sulfadimethoxine Romet®-30
200-030 Sulfadimethoxine DI-METHOX®
200-031 Sulfadimethoxine DI-METHOX®
200-038 Sulfadimethoxine Di-Methox Injection 40%, SulfadimethoxineInjection 40%
200-165 Sulfadimethoxine Sulfadimethoxine Concentrated Solution 12.5%
200-177 Sulfadimethoxine Sulfadimethoxine Injection 40%
200-192 Sulfadimethoxine Sulfadimethoxine 12.5% Oral Solution
200-238 Sulfadimethoxine Sulfasol Soluble Powder
200-251 Sulfadimethoxine Sulforal®
200-258 Sulfadimethoxine Sulfadimethoxine Soluble Powder
200-376 Sulfadimethoxine Sulfamed-G®
200-443 Sulfadimethoxine Sulfadimethoxine Soluble Powder
200-523 Sulfadimethoxine SulfaMed™
013-957 Sulfaethoxypyridazine S.E.Z. Drinking Water 6.25%
033-653 Sulfaethoxypyridazine S.E.Z. Drinking Water Solution
033-654 Sulfaethoxypyridazine S.E.Z. Oblets 15 G
033-655 Sulfaethoxypyridazine S.E.Z. Intravenous Solution
047-033 Sulfaethoxypyridazine S.E.Z. C-R Oblets 15 Gm
033-950 Sulfamerazine SULFAMERAZINE FISH GRADE
100-094 Sulfamerazine PoultrySulfa®
006-084 Sulfamethazine Sulmet® Drinking Water Solution, 12.5%
008-774 Sulfamethazine Sulmet® Solution Injectable
035-688 Sulfamethazine Aureomix® S 40/40 Granular
035-805 Sulfamethazine Aureo S 700® Granular, Aureo S 700®
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
Page:77
ApplicationNumber
Active Ingredients Trade Name
041-275 Sulfamethazine Tylan™ 5 Sulfa-G™, Tylan™ 10 Sulfa-G™,Tylan™ 20 Sulfa-G™, Tylan™ 40 Sulfa-G™
041-647 Sulfamethazine AUREOMIX® S 700-A
041-648 Sulfamethazine AUREOMIX® S 700-D
041-649 Sulfamethazine Aureomix® S 700-G
041-650 Sulfamethazine Aureomix® S 700-E
041-651 Sulfamethazine Aureomix® 700-F
041-652 Sulfamethazine Aureomix® S 700-C
041-653 Sulfamethazine AUREOMIX® S 700-B
041-654 Sulfamethazine AUREOMIX® S 700-H
049-892 Sulfamethazine Sulfamethazine Spanbolet II
091-749 Sulfamethazine Tylan® 10 Sulfa-G™, Tylan® 40 Sulfa-G™
100-094 Sulfamethazine PoultrySulfa®
120-615 Sulfamethazine Sustain III® Bolus, Sustain III® Calf Bolus
122-271 Sulfamethazine Sulmet® Oblets
126-232 Sulfamethazine Calfspan™
138-934 Sulfamethazine Pennchlor S 40/40®
140-270 Sulfamethazine Sulfamethazine Sustained Release Bolus
140-908 Sulfamethazine Veta-Meth™
140-909 Sulfamethazine Sulka-S™ Bolus
141-535 Sulfamethazine Aureo S 700® and Bovatec®
200-314 Sulfamethazine Pennchlor S®
055-012 Sulfamethazine bisulfate Chloronex® Sulmet®
030-416 Sulfamethizole Mesulfin Tablets
006-391 Sulfaquinoxaline S.Q. 40%
006-677 Sulfaquinoxaline 20% Sulfaquinoxaline Sodium Solution
006-891 Sulfaquinoxaline Sul-Q-Nox®
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
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ApplicationNumber
Active Ingredients Trade Name
007-087 Sulfaquinoxaline 25 % S.Q.® Soluble
100-094 Sulfaquinoxaline PoultrySulfa®
006-707 Sulfaquinoxaline sodium Sulquin® 6-50 Concentrate
007-981 Sulfisoxazole Soxisol Tablets
031-944 Sulfomyxin Dynamyxin Injectable
141-501 Telmisartan Semintra®
141-193 Tepoxalin Zubrin™ Rapidly-Disintegrating Tablets
141-437 Terbinafine Osurnia™
141-440 Terbinafine CLARO™
135-906 Testosterone Component™ E-H with Tylan™
011-427 Testosterone Propionate Synovex® H
010-524 Tetracaine Hydrochloride Neo-Cortef® with Tetracaine
011-703 Tetracaine Hydrochloride Neo-Delta-Cortef® with Tetracaine Ointment
015-433 Tetracaine Hydrochloride Neo-Predef® with Tetracaine Powder
030-025 Tetracaine Hydrochloride Neo-Predef® with Tetracaine Top. Ointment,Tritop® Topical Ointment
065-124 Tetracycline Tetracycline
055-073 Tetracycline Hydrochloride Panmycin® Tablets
055-076 Tetracycline Hydrochloride Albaplex® 3x Tablets, Albaplex® Tablets
065-004 Tetracycline Hydrochloride Panmycin® 500 Bolus, Panmycin® Hydrochloride
065-060 Tetracycline Hydrochloride Panmycin® Aquadrops Liquid
065-061 Tetracycline Hydrochloride Tetrachel-Vet Drops, Tetrachel-Vet Syrup
065-066 Tetracycline Hydrochloride Tetrachel-Vet Tablets 100
065-069 Tetracycline Hydrochloride Tetrachel-Vet Capsules 500
065-090 Tetracycline Hydrochloride Delta Albaplex® 3x Tablets, Delta Albaplex®Tablets
065-121 Tetracycline Hydrochloride Tetracycline-Vet Capsules 250
065-122 Tetracycline Hydrochloride Tetracyn Ointment
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ApplicationNumber
Active Ingredients Trade Name
065-123 Tetracycline Hydrochloride Tetracycline Soluble Powder
065-140 Tetracycline Hydrochloride Tet-Sol® 10, Tet-Sol® 324
065-269 Tetracycline Hydrochloride Polyotic®
065-270 Tetracycline Hydrochloride Polyotic® Oblets®
065-409 Tetracycline Hydrochloride Panmycin® Capsules
065-410 Tetracycline Hydrochloride Tetra-Sal®
065-441 Tetracycline Hydrochloride Polyotic® Soluble Powder Concentrate
065-496 Tetracycline Hydrochloride TetraSure™ 324
140-578 Tetracycline Hydrochloride SOLU-TET™
200-049 Tetracycline Hydrochloride Tetra-Bac® 324
200-136 Tetracycline Hydrochloride Tetracycline HCL Powder, TetracyclineHydrochloride Soluble Powder-324
200-234 Tetracycline Hydrochloride Tetrasol Soluble Powder
200-374 Tetracycline Hydrochloride TetraMed® 324 HCA
065-099 Tetracycline Phosphate Albaplex® Capsules
015-182 Thenium Closylate Canopar Tablets
101-161 Thenium Closylate Thenatol PW Tablets
013-022 Thiabendazole Thibenzole Sheep & Goat Wormer
013-407 Thiabendazole Equizole® Horse Wormer
013-954 Thiabendazole Thibenzole 20% Swine Premix
014-350 Thiabendazole Omnizole
015-123 Thiabendazole TBZ® Cattle Wormer (Drench)
015-875 Thiabendazole TBZ 200 Medicated Feed Premix
030-103 Thiabendazole Thibenzole (18 mg)
030-578 Thiabendazole E-Z-EX Wormer Pellets
034-114 Thiabendazole Equizole®
035-631 Thiabendazole Thibenzole Pig Wormer
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ApplicationNumber
Active Ingredients Trade Name
037-410 Thiabendazole Equizole® A
042-633 Thiabendazole Tresaderm Dermatologic Solution
042-910 Thiabendazole E-Z-EX Wormer Mintrate Block
043-141 Thiabendazole Thibenzole 300 Medicated
044-654 Thiabendazole Equizole® Horse Wormer Pellets
047-333 Thiabendazole Equizole® A Liquid
048-487 Thiabendazole TBZ® Wormer Paste 50%
049-461 Thiabendazole TBZ® Wormer Paste 43%
091-067 Thiabendazole Equivet-14, Equizole®-B
098-689 Thiabendazole Equizole® 50% Wormer Paste, Equizole® 50%Wormer Paste For Horses
200-565 Thiabendazole Thiabendazole, Dexamethasone, Neomycin SulfateSolution
008-932 Thialbarbitone Sodium Kemithal L.A.
010-809 Thiamylal Sodium Surital
039-483 Thiamylal Sodium Bio-Tal
132-028 Thiamylal Sodium Anestatal™
010-346 Thiopental Sodium Combuthal Powder
046-790 Thiopental Sodium Sodium Thiopental
012-258 Thiostrepton Panolog® Ointment
096-676 Thiostrepton Panolog® Cream
140-810 Thiostrepton DERMA-VET® Ointment
140-847 Thiostrepton Animax® Ointment
140-879 Thiostrepton Derma 4 Ointment
141-003 Thiostrepton Derm-Otic Ointment
200-245 Thiostrepton Derma-Vet Cream
200-330 Thiostrepton Animax® Cream
011-893 Thyroid Stimulating Hormone Dermathycin Injectable
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
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ApplicationNumber
Active Ingredients Trade Name
134-644 Tiamulin Denagard® Soluble Antibiotic
200-633 Tiamulin Denagard® and Deracin®
139-472 Tiamulin Hydrogen Fumarate Denagard™ 10, Denagard™ 80% Coated
140-916 Tiamulin Hydrogen Fumarate Denagard® Liquid Concentrate
141-011 Tiamulin Hydrogen Fumarate Denagard® plus CTC
200-344 Tiamulin Hydrogen Fumarate TiaGard™, Tiamulin Soluble Antibiotic
200-356 Tiamulin Hydrogen Fumarate Pennchlor™ / Denagard®
200-360 Tiamulin Hydrogen Fumarate Tiagard™, Tiamulin Liquid Concentrate
200-512 Tiamulin Hydrogen Fumarate Triamulox™
200-546 Tiamulin Hydrogen Fumarate BimaGard™ 12.5%
200-682 Tiamulin Hydrogen Fumarate Vetmulin® 12.5%
200-695 Tiamulin Hydrogen Fumarate TIA™ 12.5%
200-717 Tiamulin Hydrogen Fumarate TiaGard™ 12.5%
055-095 Ticarcillin Disodium Ticillin®
141-541 Tigilanol tiglate STELFONTA®
141-334 Tildipirosin Zuprevo™
106-111 Tiletamine Hydrochloride Telazol®
200-557 Tiletamine Hydrochloride Tzed™
200-618 Tiletamine Hydrochloride Zoletil™ for Injection
141-361 Tilmicosin Pulmotil™ AC
200-509 Tilmicosin Tilmovet® 90
140-929 Tilmicosin Phosphate Micotil™ 300
141-064 Tilmicosin Phosphate Pulmotil™ 90
141-343 Tilmicosin Phosphate Pulmotil® 90 and Rumensin® 90
141-361 Tilmicosin Phosphate Pulmotil™ AC
200-596 Tilmicosin Phosphate Tilmovet® 90 and Rumensin® 90
200-654 Tilmicosin Phosphate Tilmovet® and Monovet®
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
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ApplicationNumber
Active Ingredients Trade Name
200-655 Tilmicosin Phosphate Pulmotil™ and Monovet®
200-707 Tilmicosin Phosphate Tilmovet® AC
141-420 Tiludronate disodium Tildren®
134-645 Tioxidazole Tiox Granules
138-902 Tioxidazole Tiox Paste, Tioxidazole Paste
141-295 Toceranib Phosphate Palladia®
140-994 Tolazoline Hydrochloride Tolazine™ Injection
037-502 Tolnaftate Tinavet® Cream 1%
006-691 Toluene Vermiplex
048-010 Toluene Anaplex Caps, Canine and Feline Wormer Caps
095-333 Toluene Difolin No. 1 Capsules, Difolin No. 2.5 Capsules,Difolin No. 25 Capsules, Difolin No. 40 Capsules,Difolin No. 5 Capsules
102-020 Toluene Tri-Plex Worm Capsules
103-953 Toluene Trivermicide Worm Capsules
107-189 Toluene Worm Capsules
126-676 Toluene D & T Worm Capsules
138-612 Trenbolone Acetate Finaplix®-H, Finaplix®-S
140-897 Trenbolone Acetate Revalor®-G, Revalor®-IS, Revalor®-S
140-992 Trenbolone Acetate Revalor®-200, Revalor®-H, Revalor®-IH
141-043 Trenbolone Acetate SYNOVEX Choice®, SYNOVEX PLUS®
141-269 Trenbolone Acetate Revalor®-XH, Revalor®-XS
141-348 Trenbolone Acetate SYNOVEX® ONE FEEDLOT, SYNOVEX®ONE Grower
141-445 Trenbolone Acetate Revalor®-XR
200-221 Trenbolone Acetate Component™ TE-G, Component™ TE-G withTylan™, Component™ TE-ID with Tylan™,Component™ TE-IS, Component™ TE-IS withTylan™, Component™ TE-S, Component™ TE-Swith Tylan™
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
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ApplicationNumber
Active Ingredients Trade Name
200-224 Trenbolone Acetate Component® T-H with Tylan®, Component® T-Swith Tylan®
200-346 Trenbolone Acetate Component™ TE-200 with Tylan™,Component™ TE-H with Tylan™, Component™TE-IH with Tylan™
200-367 Trenbolone Acetate Synovex® T120, Synovex® T40, Synovex® T80
012-198 Triamcinolone Acetonide Vetalog® Parenteral
012-258 Triamcinolone Acetonide Panolog® Ointment
013-624 Triamcinolone Acetonide Triamcinolone Acetonide
046-146 Triamcinolone Acetonide Vetalog Cream
096-676 Triamcinolone Acetonide Panolog® Cream
099-388 Triamcinolone Acetonide Vetalog Oral Powder
137-694 Triamcinolone Acetonide Vetalog®
138-869 Triamcinolone Acetonide Triamcinolone Acetonide Suspension
140-810 Triamcinolone Acetonide DERMA-VET® Ointment
140-847 Triamcinolone Acetonide Animax® Ointment
140-879 Triamcinolone Acetonide Derma 4 Ointment
141-003 Triamcinolone Acetonide Derm-Otic Ointment
141-210 Triamcinolone Acetonide Genesis® Topical Spray
200-245 Triamcinolone Acetonide Derma-Vet Cream
200-275 Triamcinolone Acetonide Medalone Cream
200-330 Triamcinolone Acetonide Animax® Cream
200-226 Tricaine Methanesulfonate SYNCAINE
012-956 Trichlorfon Dyrex Bolus, Dyrex Granules
013-248 Trichlorfon Freed No. 10, Freed No. 25
015-154 Trichlorfon Dyrex T.F - 1000, Dyrex T.F - 200, Dyrex T.F -500
035-650 Trichlorfon Dyrex Powder
091-067 Trichlorfon Equivet-14, Equizole®-B
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
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ApplicationNumber
Active Ingredients Trade Name
100-402 Trichlorfon Telmin® B Equine Wormer
136-740 Trichlorfon Benzelmin® Plus Paste
138-954 Trichlorfon Telmin® B Paste
030-136 Trichlormethiazide Naquasone® Bolus
011-482 Triflupromazine Hydrochloride Vetame Injectable, Vetame Tablets
141-291 Trilostane VETORYL® CAPSULES
012-437 Trimeprazine Tartrate Temaril-P® Tablets
035-161 Trimeprazine Tartrate Temaril-P® Spansule Capsule No. 1, Temaril-P®Spansule Capsule No. 2
095-614 Trimethoprim Tribrissen® 120 Tablets, Tribrissen® 30 Tablets,Tribrissen® 480 Tablets, Tribrissen® 960 Tablets
105-093 Trimethoprim Tribrissen® 24% Injection
106-965 Trimethoprim Tribrissen® 48% Injection
115-578 Trimethoprim Di-Trim® Tablets
131-918 Trimethoprim Tribrissen® 400 Oral Paste
132-486 Trimethoprim Di-Trim® 24%
134-778 Trimethoprim Di-Trim® 48% Injection
136-342 Trimethoprim Di-Trim® 400 Paste
136-741 Trimethoprim Tribrissen® 60 Oral Suspension
141-360 Trimethoprim EQUISUL-SDT®
200-033 Trimethoprim Uniprim™ Powder
200-244 Trimethoprim Tucoprim® Powder
006-417 Tripelennamine Hydrochloride RE-COVR™
200-162 Tripelennamine Hydrochloride Tripelennamine Hydrochloride Injection
141-339 Triptorelin acetate OvuGel™
031-555 Trypsin Trypzyme® Aerosol
039-583 Trypsin Granulex® V
040-322 Trypsin Kymar Ointment Improved
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
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ApplicationNumber
Active Ingredients Trade Name
141-244 Tulathromycin Draxxin®
141-349 Tulathromycin Draxxin® 25 Injectable Solution
141-543 Tulathromycin Draxxin® KP
200-657 Tulathromycin MACROSYN™
200-665 Tulathromycin Increxxa™ 25
200-666 Tulathromycin Increxxa™
200-668 Tulathromycin Tulissin® 25
200-669 Tulathromycin Tulissin® 100
200-711 Tulathromycin TULAVEN™ 100
200-712 Tulathromycin TULAVEN™ 25
200-715 Tulathromycin AROVYN™
200-723 Tulathromycin Tulieve®
012-965 Tylosin Tylan™ 200 Injection, Tylan™ 50 Injection
135-906 Tylosin Component™ E-H with Tylan™
138-955 Tylosin Tylosin® Injection
138-995 Tylosin MGA® and Tylan™
141-149 Tylosin Deccox® and Rumensin™ and Tylan™
200-508 Tylosin BiloVet®
200-642 Tylosin Monovet® and Tylovet®
200-643 Tylosin Monovet® and Tylan™
200-644 Tylosin Optaflexx™and Monovet® and Tylovet®
200-645 Tylosin Actogain™ and Monovet® and Tylovet®
200-647 Tylosin Actogain™ and Monovet® and Tylan™
200-649 Tylosin Actogain™ and Monovet® and Tylovet® andMGA®
200-650 Tylosin Optaflexx™ and Monovet® and Tylan™ andMGA®
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients
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ApplicationNumber
Active Ingredients Trade Name
200-651 Tylosin Actogain™ and Monovet® and Tylan™ andMGA®
200-678 Tylosin Optigrid® and Monovet® and Tylovet® andMGA®
200-685 Tylosin CycleGuard® and Monovet® and Tylovet®
200-686 Tylosin Optigrid® and Monovet® and Tylovet® andCycleGuard®
012-491 Tylosin Phosphate Tylan™ 10, Tylan™ 40, Tylan™ 100, Tylan™ 100CAL
041-275 Tylosin Phosphate Tylan™ 5 Sulfa-G™, Tylan™ 10 Sulfa-G™,Tylan™ 20 Sulfa-G™, Tylan™ 40 Sulfa-G™
046-415 Tylosin Phosphate Tylan® 40
091-749 Tylosin Phosphate Tylan® 10 Sulfa-G™, Tylan® 40 Sulfa-G™
098-431 Tylosin Phosphate TYLAN™ 20, TYLAN™ 40
104-646 Tylosin Phosphate Rumensin™ and Tylan™
110-047 Tylosin Phosphate Tylan™ and Banminth®
138-870 Tylosin Phosphate MGA® and Rumensin™ and Tylan™
138-992 Tylosin Phosphate MGA® and Bovatec® and Tylan™
139-192 Tylosin Phosphate MGA® and Tylan™
141-172 Tylosin Phosphate Paylean™/Tylan™
141-224 Tylosin Phosphate Optaflexx™ and Rumensin™ and Tylan™
141-233 Tylosin Phosphate Optaflexx™ and Rumensin™ and Tylan™andMGA®
141-276 Tylosin Phosphate Zilmax® and Rumensin™ and Tylan™
141-280 Tylosin Phosphate Zilmax® and Rumensin™ and Tylan™ andMGA®
141-512 Tylosin Phosphate Experior™ and Rumensin™ and Tylan™
200-375 Tylosin Phosphate HeifermaX™ 500 / Rumensin™ / Tylan™
200-424 Tylosin Phosphate Heifermax™ / Optaflexx® / Rumensin® / Tylan®
200-427 Tylosin Phosphate Heifermax™ 500 Liquid Premix and Tylan®
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ApplicationNumber
Active Ingredients Trade Name
200-430 Tylosin Phosphate HeifermaX® 500 plus Bovatec® and Tylan™
200-480 Tylosin Phosphate Heifermax® 500/Zilmax®/Rumensin®/Tylan®
200-484 Tylosin Phosphate Tylovet® 40, Tylovet® 100
200-530 Tylosin Phosphate Paylean® plus Tylovet®
200-531 Tylosin Phosphate Rumensin® plus Tylovet® 100
200-532 Tylosin Phosphate MGA® plus Tylovet® 100
200-533 Tylosin Phosphate Deccox®, Rumensin™, and Tylovet® 100
200-534 Tylosin Phosphate MGA®, Rumensin™ and Tylovet® 100
200-535 Tylosin Phosphate MGA®/ Bovatec®/ Tylovet® 100
200-544 Tylosin Phosphate Zilmax®/Rumensin®/Tylovet® 100/MGA®
200-547 Tylosin Phosphate Zilmax®/Rumensin®/Tylovet® 100
200-558 Tylosin Phosphate Engain™ plus Tylan®
200-561 Tylosin Phosphate Actogain™ 45/Rumensin®/Tylan®
200-562 Tylosin Phosphate Actogain™ 45/Rumensin®/Tylan®/MGA®
200-566 Tylosin Phosphate Optaflexx™ 45/Rumensin®/Tylovet® 100
200-567 Tylosin Phosphate Optaflexx™ 45/Rumensin®/Tylovet® 100/MGA®
200-583 Tylosin Phosphate Actogain™ 45/Rumensin®/Tylovet® 100/MGA®
200-584 Tylosin Phosphate Engain™ plus Tylovet® 100
200-585 Tylosin Phosphate Actogain™ 45/Rumensin®/Tylovet® 100
200-646 Tylosin Phosphate Optaflexx™and Monovet® and Tylan™
200-648 Tylosin Phosphate Optaflexx™ and Monovet® and Tylovet® andMGA®
200-653 Tylosin Phosphate Deccox® and Monovet® and Tylovet®
200-656 Tylosin Phosphate Deccox® and Monovet® and Tylan™
200-660 Tylosin Phosphate MGA® and Monovet® and Tylovet®
200-661 Tylosin Phosphate MGA® and Monovet® and Tylan™
200-676 Tylosin Phosphate Optigrid® and Monovet® and Tylovet®
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ApplicationNumber
Active Ingredients Trade Name
013-076 Tylosin Tartrate Tylan Soluble™
110-315 Tylosin Tartrate Component™ E-C with Tylan™, Component™ E-S with Tylan™
200-221 Tylosin Tartrate Component™ TE-G, Component™ TE-G withTylan™, Component™ TE-ID with Tylan™,Component™ TE-IS, Component™ TE-IS withTylan™, Component™ TE-S, Component™ TE-Swith Tylan™
200-224 Tylosin Tartrate Component® T-H with Tylan®, Component® T-Swith Tylan®
200-346 Tylosin Tartrate Component™ TE-200 with Tylan™,Component™ TE-H with Tylan™, Component™TE-IH with Tylan™
200-455 Tylosin Tartrate BiloVet™
200-473 Tylosin Tartrate Tylovet® Soluble
141-460 Tylvalosin Aivlosin® 17%
141-336 Tylvalosin tartrate Aivlosin®
141-551 Vatinoxan hydrochloride Zenalpha®
141-526 Verdinexor LAVERDIA™-CA1
091-467 Virginiamycin Stafac® 500, Stafac® 10, Stafac® 20, Stafac® 50
140-998 Virginiamycin V-Max®, V-Max® 50
141-114 Virginiamycin Aviax® and Stafac®
141-289 Virginiamycin Aviax II® plus Stafac®
141-430 Virginiamycin Stafac® and Coban™
141-468 Virginiamycin Stafac® and Bio-Cox®
141-469 Virginiamycin Stafac® and AMPROL®
141-470 Virginiamycin Stafac® and Avatec®
141-472 Virginiamycin Clinacox® and Stafac®
012-635 Vitamin E BO-SE
030-313 Vitamin E Seletoc® Minicaps and Caps
030-314 Vitamin E Mu-Se
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ApplicationNumber
Active Ingredients Trade Name
030-315 Vitamin E E-SE
030-316 Vitamin E Seletoc® Injection
200-109 Vitamin E Velenium™
200-529 Xylazine XylaMed™
047-955 Xylazine Hydrochloride Rompun® Injectable (20 mg)
047-956 Xylazine Hydrochloride Rompun® Injectable (100 mg)
139-236 Xylazine Hydrochloride Anased®
140-442 Xylazine Hydrochloride Xylazine HCl Injection
200-088 Xylazine Hydrochloride Sedazine™
200-139 Xylazine Hydrochloride Chanazine®
200-184 Xylazine Hydrochloride Chanazine®
140-866 Yohimbine Hydrochloride Yobine® Injection
140-874 Yohimbine Hydrochloride Antagonil
038-233 Zeranol Ralgro® Implants, Ralgro® Magnum
141-192 Zeranol Ralgro® L. A.
141-278 Zilpaterol Zilmax® plus Rumensin®
141-282 Zilpaterol Zilmax®/Rumensin®/MGA®
200-479 Zilpaterol Heifermax® 500/Zilmax®/Rumensin®
200-480 Zilpaterol Heifermax® 500/Zilmax®/Rumensin®/Tylan®
200-483 Zilpaterol Heifermax® 500 plus Zilmax®
200-544 Zilpaterol Zilmax®/Rumensin®/Tylovet® 100/MGA®
200-547 Zilpaterol Zilmax®/Rumensin®/Tylovet® 100
141-258 Zilpaterol Hydrochloride Zilmax®
141-276 Zilpaterol Hydrochloride Zilmax® and Rumensin™ and Tylan™
141-280 Zilpaterol Hydrochloride Zilmax® and Rumensin™ and Tylan™ andMGA®
141-284 Zilpaterol Hydrochloride Zilmax® plus MGA®
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ApplicationNumber
Active Ingredients Trade Name
141-217 Zinc Gluconate Zeuterin™
011-116 Zoalene Zoamix® Type A Medicated Article
013-747 Zoalene Zoalene 90 Medicated Coccidiostat
101-629 Zoalene Flavomycin® / Zoalene
141-085 Zoalene BMD® / Zoamix®
141-130 Zoalene BMD® and Zoamix®
141-489 Zoalene Zoamix® and LINCOMIX®
200-690 Zoalene ZoaShield™ 25%
200-705 Zoalene ZoaShield™ and BMD®
106-111 Zolazepam Hydrochloride Telazol®
200-557 Zolazepam Hydrochloride Tzed™
200-618 Zolazepam Hydrochloride Zoletil™ for Injection
FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients