section 2.0 -active ingredients - fda

90
Page:1 Section 2.0 - Active Ingredients Application Number 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

Upload: others

Post on 21-May-2022

4 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: Section 2.0 -Active Ingredients - FDA

Page:1

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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

Page 62: Section 2.0 -Active Ingredients - FDA

Page:62

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

Page 63: Section 2.0 -Active Ingredients - FDA

Page:63

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: Section 2.0 -Active Ingredients - FDA

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

Page 65: Section 2.0 -Active Ingredients - FDA

Page:65

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

Page 66: Section 2.0 -Active Ingredients - FDA

Page:66

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

Page 67: Section 2.0 -Active Ingredients - FDA

Page:67

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

Page 68: Section 2.0 -Active Ingredients - FDA

Page:68

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

Page 69: Section 2.0 -Active Ingredients - FDA

Page:69

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

Page 70: Section 2.0 -Active Ingredients - FDA

Page:70

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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: Section 2.0 -Active Ingredients - FDA

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

Page 78: Section 2.0 -Active Ingredients - FDA

Page:78

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

FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients

Page 79: Section 2.0 -Active Ingredients - FDA

Page:79

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

FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients

Page 80: Section 2.0 -Active Ingredients - FDA

Page:80

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

Page 81: Section 2.0 -Active Ingredients - FDA

Page:81

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

Page 82: Section 2.0 -Active Ingredients - FDA

Page:82

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

Page 83: Section 2.0 -Active Ingredients - FDA

Page:83

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

Page 84: Section 2.0 -Active Ingredients - FDA

Page:84

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

Page 85: Section 2.0 -Active Ingredients - FDA

Page:85

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

Page 86: Section 2.0 -Active Ingredients - FDA

Page:86

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®

FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients

Page 87: Section 2.0 -Active Ingredients - FDA

Page:87

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®

FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients

Page 88: Section 2.0 -Active Ingredients - FDA

Page:88

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

FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients

Page 89: Section 2.0 -Active Ingredients - FDA

Page:89

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®

FDA Approved Animal Drug Products May 20, 2022 Section 2.0 -Active Ingredients

Page 90: Section 2.0 -Active Ingredients - FDA

Page:90

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