Green Book Section 1.1 - Trade Names and Sponsor

Page:1

Section 1.1 - Trade Names and SponsorArranged by Trade Name

ApplicationNumber

Trade Name Sponsor Name

047-333 Equizole® A Liquid Boehringer lngelheim Animal Health USA Inc.

006-677 20% Sulfaquinoxaline Sodium Solution Huvepharma EOOD

007-087 25 % S.Q.® Soluble Huvepharma EOOD

141-255 35% PEROX-AID® Syndel USA

006-983 A-H Injection Intervet, Inc.

006-602 A-H-Tablets 100 mg, A-H-Tablets 25 mg Intervet, Inc.

141-174 Acarexx® Boehringer lngelheim Animal Health USA Inc.

117-531 Acepromazine Maleate Injection Boehringer lngelheim Animal Health USA Inc.

200-319 Acepromazine Maleate Injection Elanco US Inc.

200-361 Acepromazine Maleate Injection Boehringer lngelheim Animal Health USA Inc.

140-583 ACTH Gel Bimeda Animal Health Limited

200-548 Actogain™ 45 Zoetis Inc.

200-559 Actogain™ 45 plus Rumensin® Zoetis Inc.

200-560 Actogain™ 45/Rumensin®/MGA® Zoetis Inc.

200-561 Actogain™ 45/Rumensin®/Tylan® Zoetis Inc.

200-562 Actogain™ 45/Rumensin®/Tylan®/MGA®

Zoetis Inc.

200-585 Actogain™ 45/Rumensin®/Tylovet® 100 Zoetis Inc.

200-583 Actogain™ 45/Rumensin®/Tylovet®100/MGA®

Zoetis Inc.

200-662 Actogain™ and Monovet® Huvepharma EOOD

200-659 Actogain™ and Monovet® and MGA® Huvepharma EOOD

200-647 Actogain™ and Monovet® and Tylan™ Huvepharma EOOD

200-651 Actogain™ and Monovet® and Tylan™and MGA®

Huvepharma EOOD

FDA Approved Animal Drug Products October 19, 2021 Section 1.1 - Trade Names and Sponsor

Page:2

ApplicationNumber


200-645 Actogain™ and Monovet® and Tylovet® Huvepharma EOOD

200-649 Actogain™ and Monovet® and Tylovet®and MGA®

Huvepharma EOOD

139-191 Adams™, D-Worm™, Dog WormerChewable Tablets

Farnam Companies, Inc.

141-038 Adequan® Canine American Regent, Inc.

140-901 Adequan® i.m., Adequan® i.m. Multi-Dose

American Regent, Inc.

136-383 Adequan® Injectable American Regent, Inc.

008-760 Adrenomone Dechra, Ltd.

141-077 Adspec® Sterile Solution Zoetis Inc.

141-254 Advantage Multi® for Cats Elanco US Inc.

141-251 Advantage Multi™ for Dogs Elanco US Inc.

141-208 Advantage® DUO Elanco US Inc.

141-435 advantus™ Elanco US Inc.

141-207 Advocin™ Sterile Injectable Solution Zoetis Inc.

041-245 Agribon Injection 40%, Albon® Zoetis Inc.

031-205 AGRIBON® Concentrated Solution12.5%, ALBON® Concentrated Solution12.5%

Zoetis Inc.

200-128 Agrimycin® - 200 Huvepharma EOOD

200-066 AGRIMYCIN®-343 Huvepharma EOOD

141-336 Aivlosin® ECO LLC

141-460 Aivlosin® 17% ECO LLC

055-072 Albacillin® Suspension, Special Formula17900-Forte® Suspension

Zoetis Inc.

200-205 Albac® / Amprol Hi-E® Zoetis Inc.

200-204 Albac® / Bio-Cox® Zoetis Inc.

134-830 Albac® / Coban® Zoetis Inc.

200-218 Albac® / Coyden 25® Zoetis Inc.


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ApplicationNumber


200-213 Albac® / Deccox® Zoetis Inc.

045-348 Albac® / Deccox®, Broiler FinisherMedicated

Zoetis Inc.

200-212 Albac® / Robenz® Zoetis Inc.

200-210 Albac® / Sacox® Zoetis Inc.

200-478 Albac® 50 plus Nicarb® Zoetis Inc.

098-452 Albac® 50 Type A Medicated Article Zoetis Inc.

200-223 Albac® 50 Type A Medicated Article Zoetis Inc.

055-098 Albadry Plus® Suspension Zoetis Inc.

100-808 Albamast® Suspension Zoetis Inc.

012-375 Albamix® Feed Medication Zoetis Inc.

055-076 Albaplex® 3x Tablets, Albaplex® Tablets Zoetis Inc.

065-099 Albaplex® Capsules Zoetis Inc.

043-785 Albon Oral Suspension 5% Zoetis Inc.

046-285 Albon® Zoetis Inc.

093-107 Albon® S.R. (Sustained Release) Zoetis Inc.

015-102 Albon® Tablets Zoetis Inc.

031-715 Albon®, Agribon Boluses - 2.5, AgribonBoluses - 5.0, Agribon Boluses - 15.0

Zoetis Inc.

141-342 Alfaxan® Multidose Jurox Pty. Ltd.

200-620 Altren® Aurora Pharmaceutical, Inc.

042-548 Amforol® Suspension Zoetis Inc.

042-841 Amforol® Veterinary Oral Tablets Zoetis Inc.

127-892 Amiglyde-V Zoetis Inc.

200-178 Amikacin Sulfate Injection Cronus Pharma Specialities India Private Limited

200-181 AmiMax™ E Solution Elanco US Inc.

055-087 Amoxi-Bol Zoetis Inc.

055-080 Amoxi-Doser Zoetis Inc.


Page:4

ApplicationNumber


055-085 Amoxi-Drop® Oral Suspension Zoetis Inc.

055-089 Amoxi-Inject (Cattle) Zoetis Inc.

055-091 Amoxi-Inject (Dogs and Cats) Zoetis Inc.

055-100 Amoxi-Mast Intervet, Inc.

055-088 Amoxi-Sol Zoetis Inc.

055-078 Amoxi-Tabs Zoetis Inc.

055-081 Amoxi-Tabs® Zoetis Inc.

200-709 Amoxicillin and Clavulanate Potassiumfor Oral Suspension

Cronus Pharma Specialities India Private Limited

200-702 Amoxicillin and Clavulanate PotassiumTablets


200-592 Amoxicillin Trihydrate and ClavulanatePotassium Tablets

Dechra Veterinary Products LLC

055-084 Amp-Equine Zoetis Inc.

047-997 Amphoderm Ointment Zoetis Inc.

055-074 Ampi-Bol Zoetis Inc.

055-079 Ampi-Ject Zoetis Inc.

055-042 Ampi-Tab Zoetis Inc.

200-335 Ampicillin Sodium HQ Specialty Pharma Corp.

200-180 Ampicillin Trihydrate HQ Specialty Pharma Corp.

013-461 Amprol Hi-E, Amprol Plus Huvepharma EOOD

095-543 Amprol HI-E® & Bambermycins,Amprol HI-E® / Flavomycin®

Huvepharma EOOD

036-304 Amprol HI-E® Plus Huvepharma EOOD

036-361 Amprol Plus® and Aureomycin® Zoetis Inc.

200-389 Amprolium 9.6% Oral Solution Huvepharma EOOD

200-463 Amprolium-P 9.6% Oral Solution Huvepharma EOOD

141-156 Amprol® / BMD® Zoetis Inc.


Page:5

ApplicationNumber


033-165 AMPROL® 128, Corid 20% SolublePowder

Huvepharma EOOD

012-350 Amprol® 25% Type A Medicated Article,Corid® Type A Medicated Article

Huvepharma EOOD

200-482 AmproMed™ for Calves Bimeda Animal Health Limited

200-464 AMPROMED™ For Cattle Bimeda Animal Health Limited

200-488 Ampromed™ P for Poultry Bimeda Animal Health Limited

200-496 AmproMed™ P for Poultry Bimeda Animal Health Limited

013-149 Amprovine 9.6% Solution, CORID®9.6% Oral Solution

Huvepharma EOOD

065-461 Anacetin Tablets Cronus Pharma Specialities India Private Limited

048-010 Anaplex Caps, Canine and Feline WormerCaps


038-801 Anaprime® Ophthalmic Solution Zoetis Inc.

049-725 Anaprime® Opthakote Ophthalmic Zoetis Inc.

036-211 Anaprime® Suspension Zoetis Inc.

139-236 Anased® Akorn Animal Health, Inc.

132-028 Anestatal™ Cronus Pharma Specialities India Private Limited

200-330 Animax® Cream Fougera Pharmaceuticals, Inc.

140-847 Animax® Ointment Fougera Pharmaceuticals, Inc.

200-506 Animec™ Plus Chanelle Pharmaceuticals Manufacturing Ltd.

141-080 Anipryl® Zoetis Inc.

140-874 Antagonil Wildlife Laboratories, Inc.

200-246 Anthelban V Elanco US Inc.

121-042 Anthelcide EQ® Paste Zoetis Inc.

109-722 Anthelcide EQ® Suspension Zoetis Inc.

135-940 Antirobe Aquadrops® Zoetis Inc.

120-161 Antirobe® Capsules Zoetis Inc.

141-033 Antisedan® Orion Corp.


Page:6

ApplicationNumber


141-345 apoquel® Zoetis Inc.

126-050 Apralan® 75 Elanco US Inc.

106-964 Apralan™ Elanco US Inc.

049-948 Aquachel 100 mg Zoetis Inc.

099-402 Aquachel-100, Oxyvet-100 Zoetis Inc.

141-454 AquAdvantage Salmon AquaBounty Technologies, Inc.

141-246 Aquaflor® Type A Medicated Article Intervet, Inc.

095-641 Arquel Granules Zoetis Inc.

110-201 Arquel Tablets Zoetis Inc.

141-533 Aservo® EquiHaler® Boehringer lngelheim Animal Health USA Inc.

049-032 Atgard® C Premix 9.6% Cronus Pharma Specialities India Private Limited

040-848 Atgard® C Swine Wormer Cronus Pharma Specialities India Private Limited

031-512 Atgard® Swine Wormer 27 g, Atgard®Swine Wormer 5.4g, Atgard® V SwineWormer 27 g, Atgard® V Swine Wormer5.4 g


043-606 Atgard® Swine Wormer, Atgard® VSwine Wormer


141-218 Atopica™ Elanco US Inc.

141-329 Atopica™ for Cats Elanco US Inc.

200-141 ATTANE™ Piramal Critical Care, Inc.

141-535 Aureo S 700® and Bovatec® Zoetis Inc.

035-805 Aureo S 700® Granular, Aureo S 700® Zoetis Inc.

041-651 Aureomix® 700-F Zoetis Inc.

035-688 Aureomix® S 40/40 Granular Zoetis Inc.

041-647 AUREOMIX® S 700-A Zoetis Inc.

041-653 AUREOMIX® S 700-B Zoetis Inc.

041-652 Aureomix® S 700-C Zoetis Inc.

041-648 AUREOMIX® S 700-D Zoetis Inc.


Page:7

ApplicationNumber


041-650 Aureomix® S 700-E Zoetis Inc.

041-649 Aureomix® S 700-G Zoetis Inc.

041-654 AUREOMIX® S 700-H Zoetis Inc.

200-441 Aureomycin® Pharmgate Inc.

141-250 Aureomycin® and Bovatec® Zoetis Inc.

121-553 Aureomycin® / Coban™ Zoetis Inc.

141-185 Aureomycin® / Deccox® Zoetis Inc.

200-095 Aureomycin® / Sacox® Huvepharma EOOD

048-761 Aureomycin® 50 Granular,Aureomycin® 50 Granular A,Aureomycin® 70 Granular,Aureomycin® 80 Granular,Aureomycin® 90 Granular,Aureomycin® 90 Meal, Aureomycin®100 Granular

Zoetis Inc.

141-201 Aureomycin® and Cattlyst® Zoetis Inc.

055-039 Aureomycin® Soluble Oblets Huvepharma EOOD

055-020 Aureomycin® Soluble Powder Zoetis Inc.

141-181 Avatec® / Albac® Zoetis Inc.

141-083 Avatec® / Baciferm® Zoetis Inc.

141-109 Avatec® / Baciferm® Zoetis Inc.

141-179 Avatec® / BMD® Zoetis Inc.

141-129 Avatec® / Flavomycin® Huvepharma EOOD

107-996 Avatec® / Fortracin Premix Zoetis Inc.

141-488 Avatec® and LINCOMIX® Zoetis Inc.

096-298 Avatec®, Bovatec® 150 FP, Bovatec®68 Type A Medicated Article, Bovatec®91, Bovatec® Liquid 20 (liquid Type AArticle)

Zoetis Inc.

141-289 Aviax II® plus Stafac® Phibro Animal Health Corp.

141-114 Aviax® and Stafac® Phibro Animal Health Corp.


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ApplicationNumber


141-281 Aviax® II Phibro Animal Health Corp.

141-065 Aviax™ / BMD® Phibro Animal Health Corp.

140-940 Aviax™ Premix for Broiler Chickens Phibro Animal Health Corp.

011-901 Azium® Aqueous Suspension Veterinary Intervet, Inc.

030-435 Azium® Boluses 10 mg Intervet, Inc.

092-835 Azium® Oral Solution 2 mg Intervet, Inc.

030-434 Azium® Powder Intervet, Inc.

012-559 Azium® Solution Intervet, Inc.

011-885 Azium® Tablets 0.25 mg Intervet, Inc.

097-085 Bac MD / Robenz® Zoetis Inc.

065-016 Bac-Neo-Poly Ophthalmic Ointment,Vetropolycin Ophthalmic Ointment

Dechra, Ltd.

046-920 Baciferm® - 10, Baciferm® - 25,Baciferm® - 40, Baciferm® - 50

Zoetis Inc.

140-865 Baciferm® / Albac®, Baciferm® /Monteban®

Zoetis Inc.

114-794 Baciferm® / Amprol HI-E® Premix Zoetis Inc.

139-235 Baciferm® / Bio-Cox® Zoetis Inc.

200-089 Baciferm® / Sacox® Huvepharma EOOD

065-313 Baciferm® Soluble 50 Zoetis Inc.

065-015 Bacitracin-Neomycin-Polymyxin withHydrocortisone Acetate OphthalmicOintment, Vetropolycin HC OphthalmicOintment

Dechra, Ltd.

140-839 Bactoderm® Ointment Zoetis Inc.

037-700 Bactrovet Oral Suspension 12.5% Intervet, Inc.

012-087 Bactrovet Tablets 250 mg Intervet, Inc.

118-877 Ban-A-Worm Py. Tartrate, Ban-A-WormPyrantel Tartrate Ton Pack

ADM Animal Nutrition

101-479 Banamine® , Banamine®-S Intervet, Inc.


Page:9

ApplicationNumber


106-616 Banamine® Granules Intervet, Inc.

137-409 Banamine® Paste Intervet, Inc.

141-450 Banamine® Transdermal Intervet, Inc.

092-955 Banminth® / Mecadox® Phibro Animal Health Corp.

043-290 Banminth® 48 Phibro Animal Health Corp.

042-888 Banminth®, Strongid® Zoetis Inc.

129-831 Banminth®-P Paste, Strongid® Paste Zoetis Inc.

141-068 Baytril® 100 Injectable Solution Elanco US Inc.

141-527 Baytril® 100-CA1 Elanco US Inc.

140-913 Baytril® Antibacterial Injectable Solution Elanco US Inc.

140-441 Baytril® Antibacterial Tablets, Baytril®Taste Tabs™ Antibacterial Tablets

Elanco US Inc.

200-608 Baytril® Soft Chewable Tablets Elanco US Inc.

141-176 Baytril™ Otic Elanco US Inc.

141-511 Bc2371 rDNA construct in R69 NewZealand white rabbits

LFB USA, Inc.

141-294 Bc6 rDNA construct in GTC 155-92Goats

LFB USA, Inc.

132-105 Benzelmin® Equine Anthelmic Paste,Synanthic® Oral Paste

Zoetis Inc.

133-841 Benzelmin® Equine AnthelminticSuspension, Synanthic® Suspension

Zoetis Inc.

136-740 Benzelmin® Plus Paste Zoetis Inc.

110-776 Benzelmin® Powder For Suspension Zoetis Inc.

110-777 Benzelmin® Top Dress. Zoetis Inc.

200-188 Betagen™ Topical Spray Med-Pharmex, Inc.

049-185 Betasone Aqueous Suspension Intervet, Inc.

034-010 Betavet Soluspan Suspension Intervet, Inc.

141-418 BetaVet® American Regent, Inc.


Page:10

ApplicationNumber


119-807 Beuthanasia-D Special Intervet, Inc.

200-508 BiloVet® Bimeda Animal Health Limited

200-455 BiloVet™ Bimeda Animal Health Limited

200-546 BimaGard™ 12.5% Bimeda Animal Health Limited

200-326 Bimectin® Bimeda Animal Health Limited

200-447 Bimectin® Injection for Cattle and Swine Bimeda Animal Health Limited

200-450 Bimectin® Plus Bimeda Animal Health Limited

200-318 Bimectin® Pour-On Bimeda Animal Health Limited

135-746 Bio-Cox® / BMD® Zoetis Inc.

141-136 Bio-Cox® / BMD® Zoetis Inc.

200-261 Bio-Cox® / ChlorMax™ Zoetis Inc.

134-284 Bio-Cox® / Flavomycin® Huvepharma EOOD

141-484 Bio-Cox® and LINCOMIX® Zoetis Inc.

128-686 Bio-Cox® Type A Medicated Article Huvepharma EOOD

140-859 Bio-Cox®/Aureomycin® Zoetis Inc.

095-642 Bio-Mycin C, Oxy-Tet™ Injection Boehringer lngelheim Animal Health USA Inc.

200-008 Bio-Mycin® 200 , Oxy-Tet® 200Injectable Solution

Boehringer lngelheim Animal Health USA Inc.

047-278 Bio-Mycin®, Oxy-Tet™ 50 Cronus Pharma Specialities India Private Limited

039-483 Bio-Tal Cronus Pharma Specialities India Private Limited

102-511 Biodry® Suspension, Drygard®Suspension

Zoetis Inc.

065-492 Biomox, Robamox®-V Tablets Virbac AH, Inc.

065-495 Biomox®, Robamox®-V Virbac AH, Inc.

200-113 Biosol® Liquid Zoetis Inc.

011-953 Biosol® Sterile Solution, Biosol® SterileSolution 50 mg

Zoetis Inc.

093-516 Bizolin Injection 20% Cronus Pharma Specialities India Private Limited


Page:11

ApplicationNumber


099-618 Bizolin® 1-G Cronus Pharma Specialities India Private Limited

047-712 Bizolin®-100, Bizolin®-200 Cronus Pharma Specialities India Private Limited

033-760 Bloat Guard Drench Concentrate Zoetis Inc.

032-704 Bloat Guard Top Dressing Phibro Animal Health Corp.

038-281 Bloat Guard® Phibro Animal Health Corp.

140-584 BMD / Stenorol® Huvepharma EOOD

046-592 BMD 30 Granular A, BMD 50 GranularA, BMD® 30, BMD® 50, BMD® 60

Zoetis Inc.

140-937 BMD® / Coban® Elanco US Inc.

141-140 BMD® / Coban® Zoetis Inc.

141-102 BMD® / Deccox® Zoetis Inc.

141-097 BMD® / Ivomec® Premix for Swine Boehringer lngelheim Animal Health USA Inc.

140-926 BMD® / Maxiban® Elanco US Inc.

141-124 BMD® / Maxiban® Zoetis Inc.

140-853 BMD® / Monteban® Zoetis Inc.

200-164 BMD® / Nicarmix 25® Planalquimica Industrial Ltda.

141-154 BMD® / Robenz® Zoetis Inc.

200-082 BMD® / Sacox® Huvepharma EOOD

141-144 BMD® / Safe-Guard® Zoetis Inc.

140-919 BMD® / Stenorol® Huvepharma EOOD

141-085 BMD® / Zoamix® Zoetis Inc.

141-059 BMD® and ChlorMax® Zoetis Inc.

099-150 BMD® and Coyden 25® Huvepharma EOOD

141-130 BMD® and Zoamix® Zoetis Inc.

200-358 BMD® Pennchlor® Pharmgate Inc.

065-470 BMD® Soluble Zoetis Inc.

200-242 BMD®-25, -30, -40, -50, -60, or -75 /Aureomycin® -50, -70, -80, -90 or -100

Zoetis Inc.


Page:12

ApplicationNumber


012-635 BO-SE Intervet, Inc.

139-876 Bovatec® / MGA® 100, Bovatec® /MGA® 200

Zoetis Inc.

140-288 Bovatec® / MGA® 500 Zoetis Inc.

140-579 BOVATEC® and TM® Zoetis Inc.

128-549 Bovilene Zoetis Inc.

200-514 Boviprol™ 9.6% Oral Solution Phibro Animal Health Corp.

141-426 BRAVECTO® Intervet, Inc.

141-459 BRAVECTO® Intervet, Inc.

141-532 BRAVECTO® 1-MONTH Intervet, Inc.

141-518 BRAVECTO® PLUS Intervet, Inc.

055-019 Bulk Chlortetracycline Hydrochloride Zoetis Inc.

141-228 Buscopan® Injectable Solution Boehringer lngelheim Animal Health USA Inc.

118-979 Butatron Gel Bimeda Animal Health Limited

044-756 Butatron® Bimeda Animal Health Limited

010-987 Butazolidin® Bolus, Butazolidin®Tablets

Intervet, Inc.

038-800 Butazolidin® Granules Intervet, Inc.

011-575 Butazolidin® Injectable 20% Intervet, Inc.

116-087 Butazolidin®, Butazolidin® Paste, Bute,Phenylbute™ Paste, Phenylzone® Paste

Intervet, Inc.

200-266 Butequine™ Vetoquinol USA, Inc.

200-322 Butorphanol Tartrate Injection Elanco US Inc.

200-408 Butorphanol Tartrate Injection Elanco US Inc.

200-332 Butorphic™ Injection Akorn Animal Health, Inc.

065-481 Calf Scour Boluses, ChlortetracyclinePneumonia


126-232 Calfspan™ Zoetis Inc.

096-731 Camvet Horse Wormer Paste 45% Boehringer lngelheim Animal Health USA Inc.


Page:13

ApplicationNumber


096-506 Camvet Horse Wormer Pellets Boehringer lngelheim Animal Health USA Inc.

094-642 Camvet Suspension Horse Wormer Boehringer lngelheim Animal Health USA Inc.

015-182 Canopar Tablets Intervet, Inc.

006-623 Caparsolate Sodium Boehringer lngelheim Animal Health USA Inc.

141-175 CAPSTAR® Sergeant’s Pet Care Products LLC

009-339 Carafen Cough Syrup, Carafen CoughTablets

Zoetis Inc.

118-032 Carbam® Palatabs® Bimeda Animal Health Limited

107-506 Carbam® Tablets Bimeda Animal Health Limited

135-468 Carbigran 25, Nicarbazin Elanco US Inc.

100-703 Carbocaine®-V Sterile Aqueous Solution Zoetis Inc.

141-538 Cardalis™ Ceva Sante Animale

139-879 Carnidazole, Spartrix® Wildlife Laboratories, Inc.

200-498 Carprieve® Caplets Norbrook Laboratories, Ltd.

200-595 Carprieve® Chewable Tablets Norbrook Laboratories, Ltd.

200-520 Carprieve® Injection Norbrook Laboratories, Ltd.

200-490 Carprofen Dechra Veterinary Products LLC

200-366 Carprofen Caplets, Novox® Caplets Dechra Veterinary Products LLC

200-575 Carprofen Chewable Tablets Dechra Veterinary Products LLC

200-687 Carprofen Chewable Tablets Cronus Pharma Specialities India Private Limited

200-706 CARPROFEN Chewable Tablets Felix Pharmaceuticals Pvt. Ltd.

200-578 Carprofen Flavored Tablets Belcher Pharmaceuticals, Inc.

200-593 Carprofen Injection Accord Healthcare, Inc.

200-522 Carprofen Sterile Injectable Solution Dechra Veterinary Products LLC

200-681 Carprofen Tablets Dechra Veterinary Products LLC

200-703 Carprofen Tablets Dechra Veterinary Products LLC

119-253 Cattle Block M Wildcat Feeds


Page:14

ApplicationNumber


141-025 Cattlyst® Zoetis Inc.

140-684 Cefa-Drops® Boehringer lngelheim Animal Health USA Inc.

119-688 Cefa-Tabs® Boehringer lngelheim Animal Health USA Inc.

200-616 Cefenil® RTU Norbrook Laboratories, Ltd.

200-543 Cefpodoxime Proxetil Tablets Dechra Veterinary Products LLC

200-420 Ceftiofur Sodium Sterile Powder Cephazone Pharma, LLC

141-492 Centragard® Boehringer lngelheim Animal Health USA Inc.

043-079 Centrine Injectable Zoetis Inc.

043-078 Centrine Oral Tablets Zoetis Inc.

141-263 Cerenia® Injectable Solution Zoetis Inc.

141-262 Cerenia® Tablets Zoetis Inc.

140-893 Cestex® Zoetis Inc.

200-139 Chanazine® Chanelle Pharmaceuticals Manufacturing Ltd.

200-184 Chanazine® Chanelle Pharmaceuticals Manufacturing Ltd.

102-709 Cheque® Drops Zoetis Inc.

107-347 Cheque® Medicated Dog Food Zoetis Inc.

065-460 Chloramphenicol 1% Ophthalmic,Vetrocloricin Ophthalmic Ointment

Dechra, Ltd.

065-150 Chloramphenicol Capsules Pharmaceutical Ventures, Ltd.

048-480 Chloratet™ 100, Chloratet™ 50,Chloratet™ 90

Pharmgate Inc.

200-262 ChlorMax® / Sacox® Zoetis Inc.

046-699 ChlorMax® 50, ChlorMax® 65,ChlorMax® 70, ChlorMax® 100, MicroCTC®

Zoetis Inc.

141-147 Chlormax® and Deccox® Zoetis Inc.

200-263 ChlorMax™ / Coban® Zoetis Inc.

065-149 Chloromycetin Ophthalmic Ointment Zoetis Inc.

055-047 Chloromycetin Palmitate Oral Suspension Zoetis Inc.


Page:15

ApplicationNumber


055-051 Chloromycetin Tablets 100 mg,Chloromycetin Tablets 250 mg,Chloromycetin Tablets 500 mg

Zoetis Inc.

065-440 Chloronex® Pharmgate Inc.

055-012 Chloronex® Sulmet® Huvepharma EOOD

046-789 Chloropent Zoetis Inc.

200-236 Chlortetracycline HCL Soluble Powder Quo Vademus, LLC

065-480 Chlortetracycline hydrochloride solublepowder

Pharmgate Inc.

055-018 Chlortetracycline Hydrochloride Tablets Huvepharma EOOD

065-071 CHLORTETRACYCLINE SOLUBLEPOWDER

Pharmgate Inc.

065-256 CHLORTET™-SOLUBLE-O Pharmgate Inc.

140-927 Chorulon® Intervet, Inc.

200-579 ChronoMate™ Ceva Sante Animale

141-440 CLARO™ Elanco US Inc.

055-099 CLAVAMOX® CHEWABLE Tablets,CLAVAMOX® tablets

Zoetis Inc.

055-101 Clavamox® Drops Zoetis Inc.

141-534 CLEVOR® Orion Corp.

141-472 Clinacox® and Stafac® Elanco US Inc.

140-951 Clinacox™ Elanco US Inc.

141-153 Clinacox™ and BMD® Elanco US Inc.

141-194 Clinacox™ and BMD® Elanco US Inc.

141-158 Clinacox™ and Flavomycin® Elanco US Inc.

141-195 Clinacox™ and Flavomycin® Elanco US Inc.

200-538 ClindaMed™ Oral Drops Bimeda Animal Health Limited

200-298 Clindamycin Hydrochloride Capsules Cronus Pharma Specialities India Private Limited

200-398 Clindamycin Hydrochloride Oral Drops First Priority, Inc.


Page:16

ApplicationNumber


200-193 Clindamycin Hydrochloride Oral Liquid Cronus Pharma Specialities India Private Limited

200-291 Clinsol® Virbac AH, Inc.

200-316 Clintabs® Virbac AH, Inc.

141-120 Clomicalm™ Tablets Virbac AH, Inc.

200-635 Clomipramine Hydrochloride Tablets Mizner Bioscience LLC

092-286 CLTC® 10, CLTC® 20, CLTC® 30,CLTC® 50, CLTC® 70

Phibro Animal Health Corp.

092-287 CLTC® 50 MR, CLTC® 100 MR Phibro Animal Health Corp.

138-456 Coban® / BMD® Zoetis Inc.

140-955 Coban® / Flavomycin® Elanco US Inc.

130-736 Coban™ Elanco US Inc.

038-878 Coban™ 60, Coban™ 90 Elanco US Inc.

141-491 Coban™ and LINCOMIX® Zoetis Inc.

047-933 Coban™ plus Baciferm® Elanco US Inc.

049-463 Coban™ plus BMD® Elanco US Inc.

099-006 Coban™/TM® Phibro Animal Health Corp.

200-630 CocciAid® Aurora Pharmaceutical, Inc.

013-663 Cocciprol™ Phibro Animal Health Corp.

065-506 Combi-PEN-48® Bimeda Animal Health Limited

010-346 Combuthal Powder Bimeda Animal Health Limited

141-277 Comfortis® Elanco US Inc.

200-224 Component® T-H with Tylan®,Component® T-S with Tylan®

Elanco US Inc.

110-315 Component™ E-C with Tylan™,Component™ E-S with Tylan™

Elanco US Inc.

135-906 Component™ E-H with Tylan™ Elanco US Inc.

200-346 Component™ TE-200 with Tylan™,Component™ TE-H with Tylan™,Component™ TE-IH with Tylan™

Elanco US Inc.


Page:17

ApplicationNumber


200-221 Component™ TE-G, Component™TE-G with Tylan™, Component™ TE-ID with Tylan™, Component™ TE-IS, Component™ TE-IS with Tylan™,Component™ TE-S, Component™ TE-Swith Tylan™

Elanco US Inc.

118-123 Compudose™ 200, Encore™(Compudose 400™ )

Elanco US Inc.

095-183 Conofite® Cream 2% Intervet, Inc.

095-184 Conofite® Lotion 1% Intervet, Inc.

200-282 Continuex™ Farnam Companies, Inc.

141-285 Convenia® Zoetis Inc.

141-417 CORAXIS™ Elanco US Inc.

011-700 Cortaba® Tablets Zoetis Inc.

065-476 Cortisporin Veterinary OphthalmicOintment

Intervet, Inc.

034-393 Coyden 25® Huvepharma EOOD

049-934 Coyden 25® with Bacitracin Zinc Huvepharma EOOD

141-419 Coyden® and Flavomycin® Huvepharma EOOD

141-485 COYDEN® and LINCOMIX® Zoetis Inc.

046-209 COYDEN® plus CTC Huvepharma EOOD

141-494 Credelio™ Elanco US Inc.

141-528 Credelio™ CAT Elanco US Inc.

065-130 Crystalline Pro Penicillin G Zoetis Inc.

141-187 Crystalyx® Iono-Lyx® Ridley USA Inc.

065-174 Crysticillin Zoetis Inc.

065-486 CTC Bisulfate Soluble Powder Cronus Pharma Specialities India Private Limited

136-742 Curatrem® Drench, Curatrem® DrenchFor Cattle


107-345 Cutter Paste, Rintal® Paste Elanco US Inc.

200-692 CYCLAVANCE™ Virbac AH, Inc.


Page:18

ApplicationNumber


200-399 CycleGuard® 500 Huvepharma EOOD

200-683 CycleGuard® and Monovet® Huvepharma EOOD

200-685 CycleGuard® and Monovet® andTylovet®

Huvepharma EOOD

200-627 Cyclosporine Capsules, USP MODIFIED Dechra Veterinary Products LLC

141-220 Cydectin® Elanco US Inc.

141-099 Cydectin® (moxidectin) Pour-On forBeef and Dairy Cattle

Elanco US Inc.

141-247 Cydectin® Oral Drench for Sheep Elanco US Inc.

139-075 Cygro® Zoetis Inc.

098-379 CYSTORELIN® Boehringer lngelheim Animal Health USA Inc.

014-366 Cytobin Tablets Zoetis Inc.

126-676 D & T Worm Capsules Cronus Pharma Specialities India Private Limited

115-579 Dandrex Farnam Companies, Inc.

015-147 Darbazine Injectable Zoetis Inc.

013-201 Darbazine Spansule Capsule No.1 Zoetis Inc.

055-070 Dariclox® Intervet, Inc.

039-417 Deccox® Zoetis Inc.

141-060 Deccox® - M Medicated Powder forWhole Milk

Zoetis Inc.

141-148 Deccox® / Rumensin® Zoetis Inc.

045-444 Deccox® and Aureomycin® Zoetis Inc.

141-483 Deccox® and LINCOMIX® Zoetis Inc.

200-652 Deccox® and Monovet® Huvepharma EOOD

200-656 Deccox® and Monovet® and Tylan™ Huvepharma EOOD

200-653 Deccox® and Monovet® and Tylovet® Huvepharma EOOD

141-149 Deccox® and Rumensin™ and Tylan™ Zoetis Inc.

200-622 Deccox® plus Deracin® Pharmgate Inc.


Page:19

ApplicationNumber


200-533 Deccox®, Rumensin™, and Tylovet®100

Huvepharma EOOD

141-061 Dectomax® Injectable Solution for Cattleand Swine

Zoetis Inc.

141-095 Dectomax® Pour-on Solution for Cattle Zoetis Inc.

065-090 Delta Albaplex® 3x Tablets, DeltaAlbaplex® Tablets

Zoetis Inc.

200-633 Denagard® and Deracin® Pharmgate Inc.

140-916 Denagard® Liquid Concentrate Elanco US Inc.

141-011 Denagard® plus CTC Elanco US Inc.

134-644 Denagard® Soluble Antibiotic Elanco US Inc.

139-472 Denagard™ 10, Denagard™ 80% Coated Elanco US Inc.

012-204 Depo-Medrol® (20 mg) Sterile AqueousSuspension

Zoetis Inc.

200-510 Deracin® 50 Meal, Deracin® 90 Meal,Deracin® 100 Meal

Pharmgate Inc.

200-617 Deracin® plus Bovatec® Pharmgate Inc.

200-704 Deracoxib Chewable Tablets Felix Pharmaceuticals Pvt. Ltd.

141-203 Deramaxx® Chewable Tablets Elanco US Inc.

141-003 Derm-Otic Ointment Zoetis Inc.

140-879 Derma 4 Ointment Zoetis Inc.

200-245 Derma-Vet Cream Med-Pharmex, Inc.

140-810 DERMA-VET® Ointment Med-Pharmex, Inc.

011-893 Dermathycin Injectable Intervet, Inc.

200-674 Detomequin™ Modern Veterinary Therapeutics, LLC

099-604 Dex-A-Vet Injection Bimeda Animal Health Limited

099-605 Dex-A-Vet Injection Bimeda Animal Health Limited

130-660 Dexachel Zoetis Inc.

099-607 Dexameth-A-Vet Bimeda Animal Health Limited


Page:20

ApplicationNumber


099-606 Dexameth-A-Vet Injection Bimeda Animal Health Limited

200-324 Dexamethasone Injection Sparhawk Laboratories, Inc.

123-815 Dexamethasone Sodium Phosphate Inj. Cronus Pharma Specialities India Private Limited

200-108 Dexamethasone Solution Huvepharma EOOD

200-456 Dexamethasone Solution Med-Pharmex, Inc.

111-369 Dexamethasone Sterile Solution Kinetic Technologies, LLC

141-267 Dexdomitor® Orion Corp.

200-317 Dexium-SP™ Bimeda Animal Health Limited

200-312 Dexium® Bimeda Animal Health Limited

095-218 Dexium™ Tablets Bimeda Animal Health Limited

200-573 Dexmedetomidine HCl Dechra Veterinary Products LLC

200-699 Dexmedetomidine HydrochlorideInjection

Akorn Animal Health, Inc.

200-038 Di-Methox Injection 40%,Sulfadimethoxine Injection 40%

Huvepharma EOOD

200-030 DI-METHOX® Huvepharma EOOD

200-031 DI-METHOX® Agri Laboratories, Ltd.

132-486 Di-Trim® 24% Zoetis Inc.

136-342 Di-Trim® 400 Paste Zoetis Inc.

134-778 Di-Trim® 48% Injection Zoetis Inc.

115-578 Di-Trim® Tablets Zoetis Inc.

055-032 Dicloxin Capsules Zoetis Inc.

141-096 Dicural® Tablets Boehringer lngelheim Animal Health USA Inc.

092-836 Diethylcarbamazine Citrate Tab., Diro-Form

Lloyd, Inc.

095-333 Difolin No. 1 Capsules, Difolin No.2.5 Capsules, Difolin No. 25 Capsules,Difolin No. 40 Capsules, Difolin No. 5Capsules

Zoetis Inc.

035-265 Diquel Solution Intervet, Inc.


Page:21

ApplicationNumber


011-222 Diquel Tablet Intervet, Inc.

200-609 DIROBAN® Anzac Animal Health, LLC

131-808 Dirocide Syrup Zoetis Inc.

093-512 Dirocide Tablets Zoetis Inc.

129-034 Disal® Boehringer lngelheim Animal Health USA Inc.

131-538 Disal® Boehringer lngelheim Animal Health USA Inc.

127-034 Disal® Injection Boehringer lngelheim Animal Health USA Inc.

012-734 Diuril® Boehringer lngelheim Animal Health USA Inc.

011-678 Diuril® Tablet Boehringer lngelheim Animal Health USA Inc.

011-674 Dizan Powder Cronus Pharma Specialities India Private Limited

012-469 Dizan Suspension With Piperazine Cronus Pharma Specialities India Private Limited

011-531 Dizan Tablets Cronus Pharma Specialities India Private Limited

101-331 Dog Wormer Tablets Farnam Companies, Inc.

200-239 Dolorex® Intervet, Inc.

140-999 Domitor® Orion Corp.

047-925 Domoso® Gel Zoetis Inc.

032-168 Domoso® Solution Zoetis Inc.

034-879 Dopram®-V Injectable Boehringer lngelheim Animal Health USA Inc.

141-306 Dormosedan Gel® Orion Corp.

140-862 Dormosedan™ Orion Corp.

200-637 Doxidyl™ Ceva Sante Animale

141-082 Doxirobe™ Gel Zoetis Inc.

141-244 Draxxin® Zoetis Inc.

141-349 Draxxin® 25 Injectable Solution Zoetis Inc.

141-543 Draxxin® KP Zoetis Inc.

111-607 Droncit® 5.68% Injectible Solution Elanco US Inc.


Page:22

ApplicationNumber


111-798 Droncit® Canine Cestocide Tablets,Droncit® Canine Tablets (Rx), Droncit®Feline Cestocide Tablets, Praziquantel34 (Rx), Tapeworm Dewormer for Cats(OTC), Tapeworm Dewormer for Dogs(OTC)

Elanco US Inc.

141-007 Drontal® Plus, Drontal® Plus TasteTabs®, Quad Dewormer

Elanco US Inc.

141-008 Drontal® Tablets Elanco US Inc.

055-058 Dry-Clox® Intramammary Infusion Boehringer lngelheim Animal Health USA Inc.

055-097 Dry-Mast HQ Specialty Pharma Corp.

065-498 Dual-Cillin™, Pen BP-48 Huvepharma EOOD

141-421 Duocare™ Boehringer lngelheim Animal Health USA Inc.

065-169 Dura-biotic, Flo-cillin® Zoetis Inc.

031-944 Dynamyxin Injectable Zoetis Inc.

012-956 Dyrex Bolus, Dyrex Granules Zoetis Inc.

035-650 Dyrex Powder Zoetis Inc.

015-154 Dyrex T.F - 1000, Dyrex T.F - 200, DyrexT.F - 500

Zoetis Inc.

030-315 E-SE Intervet, Inc.

042-910 E-Z-EX Wormer Mintrate Block ADM Animal Nutrition

030-578 E-Z-EX Wormer Pellets ADM Animal Nutrition

141-330 Easotic® Virbac AH, Inc.

141-200 EAZI-BREED™ CIDR® Cattle Insert Zoetis Inc.

141-302 EAZI-BREED™ CIDR® Sheep Insert Zoetis Inc.

200-348 Ecomectin Huvepharma EOOD

141-536 Elura™ Elanco US Inc.

141-015 Enacard® Tablets For Dogs Boehringer lngelheim Animal Health USA Inc.

200-542 Engain™ 9 and Engain™ 45 Zoetis Inc.

200-558 Engain™ plus Tylan® Zoetis Inc.


Page:23

ApplicationNumber


200-584 Engain™ plus Tylovet® 100 Zoetis Inc.

136-214 Enproal Bloat Blox Ridley USA Inc.

200-697 Enrofloxacin Accord Healthcare, Inc.

200-708 Enrofloxacin Felix Pharmaceuticals Pvt. Ltd.

200-527 Enrofloxacin Antibacterial InjectableSolution


200-551 Enrofloxacin Flavored Tablets Dechra Veterinary Products LLC

200-680 Enrofloxacin Flavored Tablets Felix Pharmaceuticals Pvt. Ltd.

200-495 Enroflox® 100 Norbrook Laboratories, Ltd.

200-513 Enroflox™ Injection for Dogs 2.27% Norbrook Laboratories, Ltd.

200-598 EnroMed™ 100 Bimeda Animal Health Limited

065-107 Entromycin Powder Zoetis Inc.

141-457 ENTYCE™ Elanco US Inc.

141-079 Eprinex® Pour-On for Beef and DairyCattle


200-563 Eprizero® Norbrook Laboratories, Ltd.

200-320 Equell® Virbac AH, Inc.

140-857 Equestrolin™ Virbac AH, Inc.

045-514 EquiBute Injection Zoetis Inc.

045-515 EquiBute Tablets 100 mg Zoetis Inc.

141-314 Equidone® Gel Dechra, Ltd.

035-918 Equigard, Verdisol Cronus Pharma Specialities India Private Limited

048-237 Equigel Cronus Pharma Specialities India Private Limited

111-529 Equimate® Elanco US Inc.

141-215 Equimax® Virbac AH, Inc.

141-458 Equioxx® Boehringer lngelheim Animal Health USA Inc.

141-313 Equioxx® Injection Boehringer lngelheim Animal Health USA Inc.

141-253 Equioxx® Oral Paste Boehringer lngelheim Animal Health USA Inc.


Page:24

ApplicationNumber


113-510 Equipalazone Vetoquinol N.-A., Inc.

034-705 Equipoise® Zoetis Inc.

096-675 Equiproxen 10% Solution Zoetis Inc.

096-674 Equiproxen Granules Zoetis Inc.

141-360 EQUISUL-SDT® Aurora Pharmaceutical, Inc.

091-067 Equivet-14, Equizole®-B Farnam Companies, Inc.

034-114 Equizole® Boehringer lngelheim Animal Health USA Inc.

098-689 Equizole® 50% Wormer Paste,Equizole® 50% Wormer Paste For Horses


037-410 Equizole® A Boehringer lngelheim Animal Health USA Inc.

013-407 Equizole® Horse Wormer Boehringer lngelheim Animal Health USA Inc.

044-654 Equizole® Horse Wormer Pellets Boehringer lngelheim Animal Health USA Inc.

200-334 Equizone 100™ A & G Pharmaceuticals, Inc.

139-913 Equron® Zoetis Inc.

134-314 EQVALAN® Boehringer lngelheim Animal Health USA Inc.

127-443 Eqvalan® Injection Boehringer lngelheim Animal Health USA Inc.

140-439 Eqvalan® Oral Liquid For Horses Boehringer lngelheim Animal Health USA Inc.

037-586 Erythromast 36 Zoetis Inc.

012-123 Erythro® - 100, 200, Gallimycin®-100 Bimeda Animal Health Limited

101-690 Erythro®-100 Injection Bimeda Animal Health Limited

035-455 Erythro®-36 Dry, Gallimycin®-36 Dry Bimeda Animal Health Limited

031-553 ESB 3 Soluble Powder, ESB 3 Solution Zoetis Inc.

200-310 estroPLAN™ Injection Parnell Technologies Pty. Ltd.

113-645 Estrumate®, Heifex® Intervet, Inc.

141-274 Etogesic® Sterile Injectable Solution Boehringer lngelheim Animal Health USA Inc.

141-108 EtoGesic® Tablets Boehringer lngelheim Animal Health USA Inc.

200-280 Euthanasia-III Solution Med-Pharmex, Inc.


Page:25

ApplicationNumber


200-071 Euthasol® Virbac AH, Inc.

141-209 EXCEDE® Zoetis Inc.

141-235 EXCEDE® FOR SWINE Zoetis Inc.

140-890 Excenel Sterile Suspension, Excenel®RTU, Excenel® Sterile Powder

Zoetis Inc.

141-288 EXCENEL® RTU EZ Zoetis Inc.

200-350 Exodus™ Paste, Exodus® Multi Dose Bimeda Animal Health Limited

141-508 Experior™ 10, Experior™ 50 Elanco US Inc.

141-514 Experior™ and Rumensin™ Elanco US Inc.

141-512 Experior™ and Rumensin™ and Tylan™ Elanco US Inc.

139-237 Factrel®, Factrel® Injection Zoetis Inc.

034-266 Famix Famphur Premix Intervet, Inc.

011-644 Felac Zoetis Inc.

141-292 Felimazole® Dechra, Ltd.

065-178 Fermycin™ Soluble Phibro Animal Health Corp.

010-865 Ferrextran 100 Zoetis Inc.

200-587 FerroForte® Ceva Sante Animale

200-134 FERTAGYL® Intervet, Inc.

200-069 Fertelin™, OvaCyst™ Bimeda Animal Health Limited

104-493 Filaribits® Chewable Tablets Zoetis Inc.

136-483 Filaribits® Plus Chewable Tablets Zoetis Inc.

120-326 Filban Chewable Wafers Intervet, Inc.

124-842 Filban Tablets Intervet, Inc.

138-612 Finaplix®-H, Finaplix®-S Intervet, Inc.

141-069 First Guard® Sterile Powder Zoetis Inc.

132-448 Flavomycin® ADM Animal Nutrition

140-942 Flavomycin® / Maxiban® Elanco US Inc.


Page:26

ApplicationNumber


098-340 Flavomycin® / Monensin Huvepharma EOOD

140-845 Flavomycin® / Monteban® Huvepharma EOOD

200-083 Flavomycin® / Sacox® Huvepharma EOOD

137-483 Flavomycin® / Stenorol® Huvepharma EOOD

140-918 Flavomycin® / Stenorol® Huvepharma EOOD

101-629 Flavomycin® / Zoalene Huvepharma EOOD

044-759 Flavomycin® 4 Huvepharma EOOD

130-185 Flavomycin® and Amprol®/ Amprol25%® and Flavomycin®

Huvepharma EOOD

200-589 FLORCON Med-Pharmex, Inc.

200-519 Florvio™ 2.3% Concentrate Solution Elanco US Inc.

200-061 Flu-Nix™ Huvepharma EOOD

030-414 Flucort® Solution Zoetis Inc.

030-415 Flucort® Tablets Zoetis Inc.

200-581 Flunazine® Bimeda Animal Health Limited

200-489 Flunazine®-S Bimeda Animal Health Limited

200-387 Flunazine™ Bimeda Animal Health Limited

200-308 Flunixin Injection Norbrook Laboratories, Ltd.

200-476 Flunixin Injection - S Norbrook Laboratories, Ltd.

200-124 Flunixin Meglumine Injection Elanco US Inc.

200-142 Flunixin Meglumine Solution Zoetis Inc.

036-212 Fluosmin Suspension Zoetis Inc.

014-170 Fluothane, Halothane, USP Zoetis Inc.

141-431 FOLLTROPIN® Vetoquinol USA, Inc.

006-103 Follutein Veterinary Zoetis Inc.

200-414 Formacide-B B.L. Mitchell, Inc.

137-687 Formalin-F Natchez Animal Supply Co.


Page:27

ApplicationNumber


065-383 Formula A-34, Uni Biotic 4 Dose Bimeda Animal Health Limited

065-119 Forte Topical® Ointment Zoetis Inc.

013-248 Freed No. 10, Freed No. 25 Zoetis Inc.

031-447 Fulvicin U/F® Bolus Veterinary Intervet, Inc.

039-792 Fulvicin U/F® Powder Intervet, Inc.

012-227 Fulvicin U/F® Tablets Intervet, Inc.

100-854 Fura Ointment Farnam Companies, Inc.

122-447 Fura-Septin Soluble Dressing Bimeda Animal Health Limited

132-427 Fura-Zone Squire Laboratories, Inc.

111-104 Furall Farnam Companies, Inc.

118-550 Furos-A-Vet Bimeda Animal Health Limited

200-293 Furosemide Injection 5% Elanco US Inc.

200-373 Furosemide Syrup 1% First Priority, Inc.

200-382 Furosemide Syrup 1% Cronus Pharma Specialities India Private Limited

032-319 Furox® Aerosol Powder, TopazoneAerosol Powder

Kinetic Technologies, LLC

141-034 GAINPRO® 10 Huvepharma EOOD

035-157 Gallimycin® PFC Bimeda Animal Health Limited

010-092 Gallimycin®-100P Bimeda Animal Health Limited

035-456 Gallimycin®-36 Sterile Bimeda Animal Health Limited

141-455 GALLIPRANT® Elanco US Inc.

091-191 Garacin® Intervet, Inc.

103-037 Garacin® Piglet Injection Intervet, Inc.

133-836 Garacin® Soluble Powder Intervet, Inc.

101-862 Garasol® Injection Intervet, Inc.

092-523 Garasol® Solution Intervet, Inc.

141-123 GastroGard® Boehringer lngelheim Animal Health USA Inc.


Page:28

ApplicationNumber


091-327 Gastrografin® Zoetis Inc.

200-388 GB Topical Spray Dechra Veterinary Products LLC

200-287 GBC Ointment™ Cronus Pharma Specialities India Private Limited

044-012 Gecolate Summit Hill Laboratories

048-854 Gecolate, Glycodex Injection Summit Hill Laboratories

200-185 GEN-GARD® Huvepharma EOOD

141-210 Genesis® Topical Spray Virbac AH, Inc.

200-147 Genta-Ject®, Gentamicin SulfateInjection

Huvepharma EOOD

200-102 Gentaglyde™ Solution Zoetis Inc.

200-137 GentaMax® 100 Elanco US Inc.

200-494 GentaMed™ Bimeda Animal Health Limited

200-468 GentaMed™-P for Poultry Injection Bimeda Animal Health Limited

200-115 Gentamex™ 100 Bimeda Animal Health Limited

200-394 Gentamicin Piglet Injection Sparhawk Laboratories, Inc.

137-310 Gentamicin Sulfate Inj. Sol. Cronus Pharma Specialities India Private Limited

200-576 Gentamicin Sulfate Ophthalmic Solution Akorn Animal Health, Inc.

200-174 Gentamicin Sulfate Pig Pump OralSolution

Huvepharma EOOD

200-395 Gentamicin Sulfate Solution Sparhawk Laboratories, Inc.

200-023 Gentamicin Sulfate Solution 100 mg/ml Cronus Pharma Specialities India Private Limited

200-037 Gentamicin Sulfate Solution, LegacySterile Solution

Huvepharma EOOD

200-415 Gentamicin Sulfate Topical Spray First Priority, Inc.

200-416 Gentamicin Topical Spray Sparhawk Laboratories, Inc.

200-191 Gentasol Med-Pharmex, Inc.

130-464 Gentocin® (Garacin) Pig Pump OralSolution

Intervet, Inc.

034-267 Gentocin® Durafilm® Intervet, Inc.


Page:29

ApplicationNumber


098-989 Gentocin® Ophthalmic Ointment Intervet, Inc.

099-008 Gentocin® Ophthalmic Solution Intervet, Inc.

046-821 Gentocin® Otic Solution Intervet, Inc.

130-952 Gentocin® Pink Eye Spray Intervet, Inc.

038-292 Gentocin® Solution Intervet, Inc.

046-724 Gentocin® Solution Intervet, Inc.

132-338 Gentocin® Topical Spray Intervet, Inc.

200-190 GENTORAL® Med-Pharmex, Inc.

110-399 Gleptosil, Heptomer Injection Ceva Sante Animale

200-365 Glycopyrrolate Injectable, Robinul®-V Cronus Pharma Specialities India Private Limited

065-081 Go-Dry™, Masti-Clear® HQ Specialty Pharma Corp.

200-541 Gonabreed™ Parnell Technologies Pty. Ltd.

039-583 Granulex® V Mylan Institutional, Inc.

200-391 Griseofulvin Powder Bimeda Animal Health Limited

013-755 Grysio (Microsize) Zoetis Inc.

200-230 Guaifenesin Injection Elanco US Inc.

136-651 Guailaxin Zoetis Inc.

141-423 HALAMID® AQUA Axcentive SARL

092-483 Halox Bolus Intervet, Inc.

048-913 Halox Wormer Drench Intervet, Inc.

200-372 Han-Pen™ HQ Specialty Pharma Corp.

007-829 Happy Jack Tapeworm Tablets Happy Jack, Inc.

046-746 Happy Jack Worm Capsules Happy Jack, Inc.

093-329 HavaSpan Prolonged Release Bolus,SulfaSpan Prolonged Release Bolus

Elanco US Inc.

138-412 Heartgard 30®, Heartgard® Tablets Boehringer lngelheim Animal Health USA Inc.

140-886 Heartgard® Chewables For Dogs Boehringer lngelheim Animal Health USA Inc.


Page:30

ApplicationNumber


141-078 Heartgard® for Cats Boehringer lngelheim Animal Health USA Inc.

140-971 Heartgard® Plus Boehringer lngelheim Animal Health USA Inc.

200-422 Heifermax 500 Liquid Premix andRumensin®

Elanco US Inc.

200-448 Heifermax 500®/Optaflexx®/Rumensin® Elanco US Inc.

200-451 HeifermaX® 500 plus Bovatec® Elanco US Inc.

200-430 HeifermaX® 500 plus Bovatec® andTylan™

Elanco US Inc.

200-483 Heifermax® 500 plus Zilmax® Elanco US Inc.

200-479 Heifermax® 500/Zilmax®/Rumensin® Elanco US Inc.

200-480 Heifermax® 500/Zilmax®/Rumensin®/Tylan®

Elanco US Inc.

200-424 Heifermax™ / Optaflexx® / Rumensin® /Tylan®

Elanco US Inc.

200-343 Heifermax™ 500 Elanco US Inc.

200-375 HeifermaX™ 500 / Rumensin™ /Tylan™

Elanco US Inc.

200-427 Heifermax™ 500 Liquid Premix andTylan®

Elanco US Inc.

055-021 Hetacin® K Capsules Vet Boehringer lngelheim Animal Health USA Inc.

055-048 Hetacin® K Oral Liquid Boehringer lngelheim Animal Health USA Inc.

055-022 Hetacin® K Tablets Boehringer lngelheim Animal Health USA Inc.

141-312 Hexasol™ Injection Norbrook Laboratories, Ltd.

046-288 Histavet-P® Intervet, Inc.

141-453 hLAL rDNA construct in SBC LAL-Cchickens

Alexion Pharmaceuticals, Inc.

100-616 Horseshoers Secret Thrush TreatmentAid, Thrush-XX

Farnam Companies, Inc.

140-806 Hyalovet® Boehringer lngelheim Animal Health USA Inc.

011-437 Hydeltrone Ointment Boehringer lngelheim Animal Health USA Inc.

011-080 Hydeltrone-TBA Suspension Boehringer lngelheim Animal Health USA Inc.


Page:31

ApplicationNumber


013-674 Hydrozide Injection Boehringer lngelheim Animal Health USA Inc.

011-948 Hygromix 2.4 Elanco US Inc.

010-918 Hygromix™ 8, Hygromix™ 2.4 Elanco US Inc.

112-048 Hylartin® V, Hylartin® V Injection Zoetis Inc.

122-578 Hyvisc® Anika Therapeutics

141-071 Imizol® Intervet, Inc.

097-288 Imizol® Equine Injection Intervet, Inc.

141-042 Immiticide Sterile Powder Boehringer lngelheim Animal Health USA Inc.

200-638 IMOXI™ Topical Solution for Cats Vetoquinol USA, Inc.

200-615 IMOXI™ Topical Solution for Dogs Vetoquinol USA, Inc.

099-667 Imposil Ceva Sante Animale

141-322 Improvest® Zoetis Inc.

141-392 Imrestor™ Elanco US Inc.

200-666 Increxxa™ Elanco US Inc.

141-325 Incurin® Intervet, Inc.

030-438 Innovar®-Vet Injection Intervet, Inc.

141-439 Inteprity™ Elanco US Inc.

141-495 Inteprity™ and Bio-Cox® Elanco US Inc.

141-465 Inteprity™ and Coban™ Elanco US Inc.

141-466 Inteprity™ and Maxiban™ Elanco US Inc.

141-467 Inteprity™ and Monteban™ Elanco US Inc.

140-915 Interceptor™ Elanco US Inc.

141-338 INTERCEPTOR™ PLUS Elanco US Inc.

006-281 Intragel Zoetis Inc.

200-256 Iron Dextran Injection - 200 Huvepharma EOOD

200-254 Iron Dextran Injection, Iron DextranInjection 100mg

Huvepharma EOOD


Page:32

ApplicationNumber


138-255 Iron Hydrogenated Dextran Injection Sparhawk Laboratories, Inc.

200-070 IsoFlo™ Zoetis Inc.

200-129 Isoflurane, USP Halocarbon Products Corp.

200-237 Isoflurane, USP Piramal Enterprises Ltd.

141-474 Itrafungol™ Virbac AH, Inc.

200-299 Iver-On™ Med-Pharmex, Inc.

141-257 Iverhart Max® Virbac AH, Inc.

141-441 IVERHART MAX® Chew Virbac AH, Inc.

200-302 Iverhart™ Plus Flavored Chewables Virbac AH, Inc.

200-270 Iverhart™ Tablets Virbac AH, Inc.

200-297 Ivermectin Chewable Tablets Cronus Pharma Specialities India Private Limited

200-429 Ivermectin Injection Sparhawk Laboratories, Inc.

200-390 Ivermectin Paste 1.87 % Med-Pharmex, Inc.

200-564 Ivermectin Paste 1.87% Boehringer lngelheim Animal Health USA Inc.

200-219 Ivermectin Pour-On for Cattle,Phoenectin®, Phoenectin™,Phoenectin™ Pour-On for Cattle

Huvepharma EOOD

200-292 Iversol Liquid for Horses Med-Pharmex, Inc.

128-409 Ivomec® .27% Injection Grower AndFeeder Pigs, Ivomec® 1% Injection,Ivomec® 1% Injection for Cattle AndSwine, Ivomec® Injection for Cattle


137-006 Ivomec® Cattle Paste 0.153% Boehringer lngelheim Animal Health USA Inc.

131-392 Ivomec® Liquid Boehringer lngelheim Animal Health USA Inc.

140-833 Ivomec® Plus Injection For Cattle Boehringer lngelheim Animal Health USA Inc.

140-841 Ivomec® Pour-On Boehringer lngelheim Animal Health USA Inc.

140-974 Ivomec® Premix for Swine Boehringer lngelheim Animal Health USA Inc.

140-988 Ivomec® Sustained-Release Bolus forCattle


013-181 Jenomycin Tablets Intervet, Inc.


Page:33

ApplicationNumber


034-477 Jenotone Solution Intervet, Inc.

011-877 Jenotone Tablets Intervet, Inc.

043-784 Kanfosone Ointment Zoetis Inc.

041-836 Kantrim® 200 Zoetis Inc.

042-661 Kantrim® Ophthalmic Ointment Zoetis Inc.

042-883 Kantrim® Ophthalmic Solution Zoetis Inc.

141-438 Kavault™ Elanco US Inc.

141-544 KBroVet®-CA1 Pegasus Laboratories, Inc.

008-932 Kemithal L.A. Zoetis Inc.

200-257 Ketamine HCL Mylan Institutional, LLC

200-029 Ketamine Hydrochloride Injection Cronus Pharma Specialities India Private Limited

200-042 Ketamine Hydrochloride Injection, USP Elanco US Inc.

200-073 Ketamine Hydrochloride Injection, USP Dechra Veterinary Products LLC

043-304 Ketaset® Zoetis Inc.

092-116 Ketaset® Plus Zoetis Inc.

045-290 Ketaset®, Vetalar® Boehringer lngelheim Animal Health USA Inc.

140-269 KETOFEN® Zoetis Inc.

200-625 KetoMed™ Bimeda Animal Health Limited

012-991 Kopertox® Zoetis Inc.

040-322 Kymar Ointment Improved Intervet, Inc.

046-109 L-S 50 Water Soluble® Powder Zoetis Inc.

045-188 Lasix® Packets Intervet, Inc.

102-380 Lasix® Syrup 1% Intervet, Inc.

141-526 LAVERDIA™-CA1 Anivive Lifesciences, Inc.

140-883 Legend® Injectable Solution, Legend®Multi Dose


200-313 LevaMed™ Bimeda Animal Health Limited


Page:34

ApplicationNumber


200-386 LevaMed™ Soluble Drench Powder Bimeda Animal Health Limited

200-271 Levamisole Phosphate Agri Laboratories, Ltd.

112-051 Levamisole Soluble Drench Powder,Levasole®, Levasole® Soluble DrenchPowder, Tramisol® Soluble DrenchPowder

Intervet, Inc.

112-050 Levasole Intervet, Inc.

091-826 Levasole® Cattle Wormer Bolus Intervet, Inc.

126-742 Levasole® Injectable Solution Intervet, Inc.

112-052 Levasole® Sheep Wormer Bolus,Tramisole Sheep Wormer Oblets Tablets

Intervet, Inc.

112-049 Levasole® Soluble Pig Wormer Intervet, Inc.

200-233 Linco Soluble Zoetis Inc.

040-587 Lincocin® Aquadrops Zoetis Inc.

033-887 Lincocin® Tablets Zoetis Inc.

034-025 Lincocin®, Lincomix® 25 Injectable,Lincomix® 50 Injectable, Lincomix®100 Injectable, Lincomix® 300 Injectable

Zoetis Inc.

200-368 LincoMed™ 100, LincoMed® 300 Bimeda Animal Health Limited

097-505 LINCOMIX® 20, LINCOMIX® 50 Zoetis Inc.

116-044 LINCOMIX® and Banminth® Phibro Animal Health Corp.

138-941 LINCOMIX® and Banminth® Zoetis Inc.

111-636 LINCOMIX® Soluble Powder Zoetis Inc.

200-345 Lincomycin - Spectinomycin Phibro Animal Health Corp.

200-315 Lincomycin 100, Lincomycin 25,Lincomycin 300, Lincomycin Injection100, Lincomycin Injection 25,Lincomycin Injection 300

Sparhawk Laboratories, Inc.

200-303 Lincomycin Hydrochloride SolublePowder

Quo Vademus, LLC

200-274 Lincomycin Injectable 30% Zoetis Inc.

200-351 Lincomycin Injectable, USP Huvepharma EOOD


Page:35

ApplicationNumber


200-189 Lincomycin Soluble Huvepharma EOOD

200-407 Lincomycin-Spectinomycin WaterSoluble Powder

Huvepharma EOOD

200-241 Lincosol Soluble Powder Med-Pharmex, Inc.

200-377 LinxMed-SP® Bimeda Animal Health Limited

013-293 Liqua-Cortril Spray, Terra-Cortril Spray Zoetis Inc.

094-114 Liquamycin® 100, Terramycin® 100 Zoetis Inc.

008-769 Liquamycin® Injectable, Terramycin®Injectable

Zoetis Inc.

013-146 Liquamycin® Intramuscular Zoetis Inc.

113-232 Liquamycin® LA-200®, Liquamycin®LA-200® (Rx)

Zoetis Inc.

200-007 Liqui-Vict 2X™ Happy Jack, Inc.

200-582 Loncor™ 300 Elanco US Inc.

065-087 Longicil Fortified Zoetis Inc.

141-327 Longrange® Boehringer lngelheim Animal Health USA Inc.

200-491 Loxicom® Norbrook Laboratories, Ltd.

200-497 Loxicom® Norbrook Laboratories, Ltd.

141-442 LUTALYSE® HighCon Injection Zoetis Inc.

108-901 Lutalyse® Injection Zoetis Inc.

047-870 M50-50 Diprenorphine, M99 Etorphine Wildlife Laboratories, Inc.

200-657 MACROSYN™ Bimeda Animal Health Limited

032-946 MAGNA-TERRAMYCIN® SolublePowder

Zoetis Inc.

038-160 Maolate® Tablets, Maolate® Veterinary Zoetis Inc.

200-586 Marboquin™ Dechra Veterinary Products LLC

141-188 Marquis® Antiprotozoal Oral Paste Boehringer lngelheim Animal Health USA Inc.

141-222 Matrix® Intervet, Inc.

138-952 Maxiban™ 72 Elanco US Inc.


Page:36

ApplicationNumber


200-123 Maxim-200® Injection, OxytetracyclineHydrochloride Injection 200mg

Huvepharma EOOD

141-211 Mecadox® and Terramycin® Phibro Animal Health Corp.

041-061 Mecadox® Premix 10 Phibro Animal Health Corp.

098-569 Medacide-SDM Injection 10% Cronus Pharma Specialities India Private Limited

200-275 Medalone Cream Med-Pharmex, Inc.

108-963 Medamycin® Injectable Cronus Pharma Specialities India Private Limited

065-491 Medichol Tablets Cronus Pharma Specialities India Private Limited

011-403 Medrol® Tablets Zoetis Inc.

040-001 Meldane 2 Elanco US Inc.

200-485 Meloxicam Injection Accord Healthcare, Inc.

200-540 Meloxicam Solution for Injection Dechra Veterinary Products LLC

200-550 Meloxidyl® Ceva Sante Animale

030-416 Mesulfin Tablets Zoetis Inc.

141-219 Metacam® 5 mg/mL Solution forInjection


141-213 Metacam® Oral Suspension Boehringer lngelheim Animal Health USA Inc.

135-771 Methylprednisolene Tablets Cronus Pharma Specialities India Private Limited

136-212 Methylprednisolone Acetate Inj. Cronus Pharma Specialities India Private Limited

010-312 Meticortelone Acetate Intervet, Inc.

009-963 Meticorten® Intervet, Inc.

046-718 MGA® (liquid) and TM® Zoetis Inc.

034-254 MGA® 100, MGA® 200 Zoetis Inc.

039-402 MGA® 100, MGA® 200, MGA® 500 Zoetis Inc.

124-309 MGA® 100-200 / Rumensin®, MGA®100-200 Premix / Rumensin®

Zoetis Inc.

125-476 MGA® 500 plus Rumensin® Zoetis Inc.

141-530 MGA® and Aureomycin® Zoetis Inc.


Page:37

ApplicationNumber


141-531 MGA® and Bovatec® and Aureomycin® Zoetis Inc.

138-992 MGA® and Bovatec® and Tylan™ Zoetis Inc.

200-658 MGA® and Monovet® Huvepharma EOOD

200-661 MGA® and Monovet® and Tylan™ Huvepharma EOOD

200-660 MGA® and Monovet® and Tylovet® Huvepharma EOOD

138-870 MGA® and Rumensin™ and Tylan™ Zoetis Inc.

046-719 MGA® and TM® Zoetis Inc.

138-995 MGA® and Tylan™ Zoetis Inc.

139-192 MGA® and Tylan™ Zoetis Inc.

200-532 MGA® plus Tylovet® 100 Huvepharma EOOD

200-534 MGA®, Rumensin™ and Tylovet® 100 Huvepharma EOOD

200-535 MGA®/ Bovatec®/ Tylovet® 100 Huvepharma EOOD

200-196 Miconosol Med-Pharmex, Inc.

140-929 Micotil™ 300 Elanco US Inc.

200-629 MilbeGuard™ Ceva Sante Animale

141-163 Milbemite™ Otic Solution Elanco US Inc.

141-481 Mirataz® Dechra, Ltd.

120-299 Mitaban® Liquid Concentrate Zoetis Inc.

141-177 Mometamax™ Otic Suspension Intervet, Inc.

200-536 Mometavet® Med-Pharmex, Inc.

200-639 Monovet® 90 Huvepharma EOOD

200-643 Monovet® and Tylan™ Huvepharma EOOD

200-642 Monovet® and Tylovet® Huvepharma EOOD

118-980 Monteban™ 45 Elanco US Inc.

138-993 MoorMan's® Cattle Minerals BT ADM Animal Nutrition

115-581 MoorMan's® Mintrate® Blonde BlockRU, MoorMan's® Mintrate® Red BlockRU

ADM Animal Nutrition


Page:38

ApplicationNumber


030-314 Mu-Se Intervet, Inc.

200-457 Mupirocin Ointment USP, 2% Taro Pharmaceuticals U.S.A., Inc.

200-418 Muricin™ Fougera Pharmaceuticals, Inc.

065-241 Mychel-Vet Capsules (50 mg) Zoetis Inc.

065-463 Mychel-Vet Injection Zoetis Inc.

065-489 Mychel-Vet Tabs Zoetis Inc.

065-114 Mycitracin® Sterile OphthalmicOintment

Zoetis Inc.

010-091 Mylepsin Tablets Zoetis Inc.

030-137 Mylepsin, Primidone Medi-Pets Zoetis Inc.

010-424 Nalline Hydrochloride Boehringer lngelheim Animal Health USA Inc.

030-136 Naquasone® Bolus Intervet, Inc.

140-338 Naxcel® Sterile Powder Zoetis Inc.

096-509 NBC Kaps Wormer Zoetis Inc.

128-069 Nemacide Chewable Tablets Cronus Pharma Specialities India Private Limited

092-837 Nemacide Oral Syrup Cronus Pharma Specialities India Private Limited

127-627 Nemacide, Nemacide-C Cronus Pharma Specialities India Private Limited

100-237 Nemex, Nemex-2, RFD Liquid Wormer Zoetis Inc.

200-153 Neo 200 Oral Solution Huvepharma EOOD

034-872 Neo Predef® Sterile Ointment Zoetis Inc.

093-514 Neo-Cortef® Sterile Ointment Zoetis Inc.

010-524 Neo-Cortef® with Tetracaine Zoetis Inc.

031-914 Neo-Darbazine Spansule Capsule No.1,Neo-Darbazine Spansule Capsule No.3

Zoetis Inc.

091-534 Neo-Delta Cortef® Sterile Solution Zoetis Inc.

011-703 Neo-Delta-Cortef® with TetracaineOintment

Zoetis Inc.

138-939 Neo-Oxy 100/100 MR®, Neo-Oxy50/50®

Pharmgate Inc.


Page:39

ApplicationNumber


015-433 Neo-Predef® with Tetracaine Powder Zoetis Inc.

030-025 Neo-Predef® with Tetracaine Top.Ointment, Tritop® Topical Ointment

Zoetis Inc.

200-130 Neo-Sol® 50 Huvepharma EOOD

015-151 Neo-synalar Cream Bausch Health US, LLC

094-975 Neo-Terramycin® 100/100, Neo-Terramycin® 100/100D, Neo-Terramycin® 50/50, Neo-Terramycin®50/50D


200-050 NeoMed® Soluble Powder Bimeda Animal Health Limited

140-976 Neomix Ag® 325 Medicated Premix,Neomix® 325 Medicated Premix

Zoetis Inc.

011-315 Neomix® 325 Soluble Powder, Neomix®AG 325 Soluble Powder

Zoetis Inc.

200-553 Neomycin and Polymyxin B Sulfates, andBacitracin Zinc Ophthalmic Ointment


200-379 Neomycin Liquid Sparhawk Laboratories, Inc.

200-118 Neomycin Oral Solution Huvepharma EOOD

200-046 Neomycin Sulfate Zoetis Inc.

200-378 Neomycin Sulfate 325 Sparhawk Laboratories, Inc.

200-235 Neosol Soluble Powder Med-Pharmex, Inc.

200-289 Neosol-Oral Med-Pharmex, Inc.

065-485 Neosporin Ophthalmic Ointment Intervet, Inc.

117-689 Neurosyn Tablets Cronus Pharma Specialities India Private Limited

141-406 NexGard® Boehringer lngelheim Animal Health USA Inc.

200-432 NexHA™ Vetoquinol USA, Inc.

011-154 NFZ® Puffer Neogen Corp.

140-851 NFZ® Wound Dressing Neogen Corp.

140-339 Nicarbazin (NICARB®) plusBambermycins (FLAVOMYCIN®)

Huvepharma EOOD

098-378 Nicarbazin / Bacitracin Premix Phibro Animal Health Corp.


Page:40

ApplicationNumber


141-146 Nicarb® / Baciferm® Phibro Animal Health Corp.

009-476 Nicarb® 25% Phibro Animal Health Corp.

141-279 Nicarb® 25% plus BMD® Zoetis Inc.

200-027 Nicarmix 25® Planalquimica Industrial Ltda.

130-872 Nitrofurazone Anesthetic Dress. Med-Pharmex, Inc.

125-797 Nitrofurazone Dressing Cronus Pharma Specialities India Private Limited

126-504 Nitrofurazone Ointment Bimeda Animal Health Limited

138-657 Nitrofurazone Ointment Sparhawk Laboratories, Inc.

140-881 Nitrofurazone Soluble Dressing Med-Pharmex, Inc.

200-425 Nitrofurazone Soluble Dressing First Priority, Inc.

126-236 Nitrofurazone Soluble Powder Cronus Pharma Specialities India Private Limited

141-461 Nocita™ Elanco US Inc.

009-782 Nolvasan® Antiseptic Ointment Zoetis Inc.

009-809 Nolvasan® Cap-Tabs® Zoetis Inc.

010-434 Nolvasan® Suspension Zoetis Inc.

141-350 None (Med Gas) Air Liquide America Specialty Gases

141-351 None (Med Gas) Air Liquide America Specialty Gases

141-354 None (Med Gas) Air Liquide Industrial U.S. L.P.

141-357 None (Med Gas) Air Liquide Industrial U.S. L.P.

141-358 None (Med Gas) Air Liquide Large Industries U.S. L.P.

141-359 None (Med Gas) Air Liquide Large Industries U.S. L.P.

141-362 None (Med Gas) Messer LLC

141-363 None (Med Gas) Linde Gas North America LLC



141-366 None (Med Gas) Machine and Welding Supply Company

141-367 None (Med Gas) Industrial Gas Distributors


Page:41

ApplicationNumber


141-368 None (Med Gas) Purity Cylinder Gases, Inc.

141-369 None (Med Gas) Norco, Inc.

141-370 None (Med Gas) WestAir Gases & Equipment, Inc.

141-371 None (Med Gas) Messer Merchant Production LLC

141-372 None (Med Gas) Messer Gas Puerto Rico, Inc.

141-373 None (Med Gas) Messer Canada Inc.


141-375 None (Med Gas) Norco, Inc.

141-376 None (Med Gas) Scott-Gross Company, Inc.

141-377 None (Med Gas) DuPuy Oxygen & Supply Company, Inc.

141-379 None (Med Gas) Air Liquide America L.P.


141-381 None (Med Gas) Airgas Merchant Gases, LLC

141-382 None (Med Gas) Airgas Merchant Gases, LLC

141-383 None (Med Gas) Airgas USA, LLC


141-385 None (Med Gas) Airgas Carbonic, Inc.

141-386 None (Med Gas) Oxarc, Inc.

141-387 None (Med Gas) Praxair, Inc.




141-391 None (Med Gas) NexAir, LLC

141-393 None (Med Gas) Aspen Air, US Corp

141-394 None (Med Gas) Aspen Air, US Corp

141-395 None (Med Gas) Air Products and Chemicals, Inc.



Page:42

ApplicationNumber




141-399 None (Med Gas) Matheson Tri-Gas, Inc.



141-402 None (Med Gas) Praxair Distribution Inc.

141-403 None (Med Gas) Praxair Distribution Mid-Atlantic, LLC

141-404 None (Med Gas) Praxair Distribution Mid-Atlantic, LLC

141-405 None (Med Gas) Praxair Distribution Inc.

141-407 None (Med Gas) Praxair Canada Inc.

141-408 None (Med Gas) Praxair Canada Inc.

141-409 None (Med Gas) United States Welding, Inc.

141-410 None (Med Gas) Acetylene Oxygen Company

141-411 None (Med Gas) Nitrous Oxide Corp

141-412 None (Med Gas) Nitrous Oxide of Canada




141-416 None (Med Gas) Air Liquide Healthcare America Corporation

141-425 None (Med Gas) Linde Gas North America LLC

141-428 None (Med Gas) Cee Kay Supply

141-432 None (Med Gas) American Welding & Gas Inc.

141-446 None (Med Gas) Strata Medical Innovations

141-479 None (Med Gas) Praxair Mexico, S. de R.L. de C.V.

141-486 None (Med Gas) Praxair Mexico, S. de R.L. de C.V.


141-500 None (Med Gas) A-OX Welding Supply Co., Inc.


Page:43

ApplicationNumber


010-793 Nonemic Intervet, Inc.

200-591 Norfenicol® Norbrook Laboratories, Ltd.

200-436 Normectin® Plus Norbrook Laboratories, Ltd.

065-010 Norocillin Norbrook Laboratories, Ltd.

200-437 Noromectin® Norbrook Laboratories, Ltd.

200-272 Noromectin® Pour-On for Cattle Norbrook Laboratories, Ltd.

141-143 Noromycin® 300 LA, TETRADURE™300

Norbrook Laboratories, Ltd.

141-265 NuflorGOLD™ Intervet, Inc.

141-264 Nuflor® Intervet, Inc.

141-063 Nuflor® , Nuflor®-S Intervet, Inc.

141-206 Nuflor® Concentrate Solution Intervet, Inc.

055-013 Omnipen 250 mg Zoetis Inc.

014-350 Omnizole Boehringer lngelheim Animal Health USA Inc.

141-443 onsior® injection Elanco US Inc.

141-320 onsior® Tablets for Cats Elanco US Inc.

141-463 onsior™ Elanco US Inc.

009-035 Ophthaine® Solution Zoetis Inc.

141-221 Optaflexx® 45 Elanco US Inc.

141-234 Optaflexx™ / Rumensin® / MGA® Elanco US Inc.

200-566 Optaflexx™ 45/Rumensin®/Tylovet®100

Huvepharma EOOD

200-567 Optaflexx™ 45/Rumensin®/Tylovet®100/MGA®

Huvepharma EOOD

200-650 Optaflexx™ and Monovet® and Tylan™and MGA®

Huvepharma EOOD

200-648 Optaflexx™ and Monovet® andTylovet® and MGA®

Huvepharma EOOD

141-224 Optaflexx™ and Rumensin™ andTylan™

Elanco US Inc.


Page:44

ApplicationNumber


141-233 Optaflexx™ and Rumensin™ andTylan™and MGA®

Elanco US Inc.

141-225 Optaflexx™ plus Rumensin® Elanco US Inc.

200-646 Optaflexx™and Monovet® and Tylan™ Huvepharma EOOD

200-644 Optaflexx™and Monovet® and Tylovet® Huvepharma EOOD

200-679 Optigrid® 45 Huvepharma EOOD

200-675 Optigrid® and Monovet® Huvepharma EOOD

200-684 Optigrid® and Monovet® andCycleGuard®

Huvepharma EOOD

200-677 Optigrid® and Monovet® and MGA® Huvepharma EOOD

200-676 Optigrid® and Monovet® and Tylovet® Huvepharma EOOD

200-686 Optigrid® and Monovet® and Tylovet®and CycleGuard®

Huvepharma EOOD

200-678 Optigrid® and Monovet® and Tylovet®and MGA®

Huvepharma EOOD

141-052 Optimmune® Intervet, Inc.

049-726 Optiprime® Opthakote OphthalmicSolution

Zoetis Inc.

141-305 Orbax® Intervet, Inc.

141-081 Orbax® Tablets Intervet, Inc.

055-069 Orbenin DC Intervet, Inc.

141-346 OroCAM® Transmucosal Oral Spray Zoetis Inc.

141-427 Osphos® Dechra, Ltd.

099-344 Osteum Solution 50 mg Summit Hill Laboratories

141-437 Osurnia™ Dechra, Ltd.

140-896 Otomax® Intervet, Inc.

091-603 Ovaban® Tablets 20 mg, Ovaban®Tablets 5 mg

Intervet, Inc.

200-481 OvaMed® Bimeda Animal Health Limited

141-339 OvuGel™ United-AH II, LLC


Page:45

ApplicationNumber


141-044 Ovuplant™ Virbac AH, Inc.

141-002 OXY 1000 Calf Bolus, OXY 500 CalfBolus


038-200 OXY WS™ Phibro Animal Health Corp.

141-067 Oxyglobin® OPK Biotech, LLC

045-143 Oxyject® Cronus Pharma Specialities India Private Limited

097-452 Oxyject® 100 Cronus Pharma Specialities India Private Limited

130-435 OXYMarine™, Oxytet® Soluble Huvepharma EOOD

200-452 Oxytet 100 Norbrook Laboratories, Ltd.

200-154 Oxytetracycline 200, Pennox™ 200 Pharmgate Inc.

140-582 Oxytetracycline Hydrochloride Injection Bimeda Animal Health Limited

200-068 Oxytetracycline Hydrochloride Injection Huvepharma EOOD

200-306 Oxytetracycline Injection 200 Norbrook Laboratories, Ltd.

200-117 Oxytetracycline Injection,Oxytetracycline Injection

Bimeda Animal Health Limited

048-287 Oxytetracycline-50 Huvepharma EOOD

099-169 Oxytocin (Label Under Distributors) Bimeda Animal Health Limited

109-305 Oxytocin Injectable Bimeda Animal Health Limited

046-788 Oxytocin Injection Zoetis Inc.

130-136 Oxytocin Injection Bimeda Animal Health Limited

200-328 Oxytocin Injection Bimeda Animal Health Limited

140-856 P.G. 600® Intervet, Inc.

009-167 P.L.H. Injectable Intervet, Inc.

032-738 Pacitran Zoetis Inc.

141-295 Palladia® Zoetis Inc.

132-872 Panacur® 10% Paste, Safe-Guard® Intervet, Inc.

121-473 Panacur® C (OTC), Safe-Guard® Canine(OTC), Panacur® Granules 22.2% (Rx)

Intervet, Inc.


Page:46

ApplicationNumber


111-278 Panacur® Granules 22.2% Intervet, Inc.

120-648 Panacur® Paste, Safe-Guard® Intervet, Inc.

141-286 Panacur® Plus Intervet, Inc.

104-494 Panacur® Suspension 10% Intervet, Inc.

065-004 Panmycin® 500 Bolus, Panmycin®Hydrochloride

Zoetis Inc.

065-060 Panmycin® Aquadrops Liquid Zoetis Inc.

065-409 Panmycin® Capsules Zoetis Inc.

055-073 Panmycin® Tablets Zoetis Inc.

096-676 Panolog® Cream Zoetis Inc.

012-258 Panolog® Ointment Zoetis Inc.

200-701 PARASEDGE™ Multi for Cats Chanelle Pharmaceuticals Manufacturing Ltd.

200-700 PARASEDGE™ Multi for Dogs Chanelle Pharmaceuticals Manufacturing Ltd.

140-989 PARASITE-S Syndel USA

134-779 Paratect Flex™ Zoetis Inc.

033-149 Parvex Plus® Suspension Zoetis Inc.

011-590 Parvex® Bolus Zoetis Inc.

011-299 Parvex® Suspension Zoetis Inc.

118-509 Pasture Gainer Block 20 R350, PastureGainer Block 20 R350 No SE, PastureGainer Block 37 R350, Pasture GainerBlock 37 R350 No SE

Purina Animal Nutrition LLC

140-863 Paylean® 45, Paylean® 9 Elanco US Inc.

200-530 Paylean® plus Tylovet® Huvepharma EOOD

141-172 Paylean™/Tylan™ Elanco US Inc.

065-110 PEN-G-MAX® Huvepharma EOOD

200-103 PenAqua Sol-G®, Penicillin GPotassium, USP


200-347 Penicillin G Potassium USP Quo Vademus, LLC


Page:47

ApplicationNumber


055-060 Penicillin G Potassium, USP Zoetis Inc.

065-275 Penicillin VK Filmtab 250 mg Boehringer lngelheim Animal Health USA Inc.

138-934 Pennchlor S 40/40® Pharmgate Inc.

200-314 Pennchlor S® Pharmgate Inc.

200-357 Pennchlor® / Bio-Cox® Pharmgate Inc.

200-359 Pennchlor® / Deccox® Pharmgate Inc.

138-935 Pennchlor® 50™, Pennchlor 50 G®,Pennchlor® 90 G™, Pennchlor® 100G™, Pennchlor® 100 Hi-Flo™

Pharmgate Inc.

200-354 Pennchlor™ / Coban® Pharmgate Inc.

200-356 Pennchlor™ / Denagard® Pharmgate Inc.

200-295 Pennchlor™ 64 Pharmgate Inc.

141-137 Pennitracin MD 50G® Pharmgate Inc.

141-540 Pennitracin MD® and Coban™ Pharmgate Inc.

141-529 Pennitracin MD® and Maxiban™ Pharmgate Inc.

200-026 Pennox 343® Pharmgate Inc.

138-938 Pennox 50®, Pennox 100-MR®, Pennox100 Hi-Flo®, Pennox 200 Hi-Flo®

Pharmgate Inc.

200-614 Pentobarbital Sodium and PhenytoinSodium


141-029 Percorten™-V Elanco US Inc.

108-687 Pet Derm® III Tablets Kinetic Technologies, LLC

128-517 Pet-Dec Zoetis Inc.

200-438 Petrem® Piramal Critical Care, Inc.

141-509 Pexion™ Boehringer lngelheim Animal Health USA Inc.

100-901 PfiChlor® 100S Zoetis Inc.

049-287 PfiChlor® 50, PfiChlor® 70, PfiChlor®100

Zoetis Inc.

065-483 Pfizer-Strep Zoetis Inc.


Page:48

ApplicationNumber


012-680 Pharmastatin®-20 Type A MedicatedArticle

Zoetis Inc.

046-780 Phen-Buta Vet Injection Bimeda Animal Health Limited

049-187 Phen-Buta Vet Tablets, PhenylbutazoneTablets (Horses)


096-671 Phen-Buta-Vet Injection Bimeda Animal Health Limited

096-672 Phen-Buta-Vet Tablets, PhenylbutazoneS/A


200-126 Phenylbutazone 20% Injection Elanco US Inc.

200-371 Phenylbutazone 20% Injection Sparhawk Laboratories, Inc.

091-818 Phenylbutazone Tablets, USP 1 gram Elanco US Inc.

094-170 Phenylbutazone Tablets, USP 100 mg,Phenylbutazone Tablets, USP 200 mg


200-202 Phoenectin® Elanco US Inc.

200-228 Phoenectin® Huvepharma EOOD

200-286 Phoenectin® Paste 1.87% Elanco US Inc.

141-036 Pirsue® Sterile Solution Zoetis Inc.

200-610 Placadine™ Modern Veterinary Therapeutics, LLC

055-030 Polyflex® Boehringer lngelheim Animal Health USA Inc.

055-054 PolyMast® Intramammary Infusion Boehringer lngelheim Animal Health USA Inc.

065-269 Polyotic® Huvepharma EOOD

065-270 Polyotic® Oblets® Zoetis Inc.

065-441 Polyotic® Soluble Powder Concentrate Zoetis Inc.

138-903 Porcilene® Solution Zoetis Inc.

141-266 Posatex® Otic Suspension Intervet, Inc.

140-872 Posilac™ Union Agener, Inc.

100-094 PoultrySulfa® Huvepharma EOOD

141-542 pPL657 rDNA CONSTRUCT INDOMESTIC PIGS

Revivicor, Inc., a wholly owned subsidiary ofUnited Therapeutics Corporation


Page:49

ApplicationNumber


141-331 Prascend® Boehringer lngelheim Animal Health USA Inc.

200-265 Prazi-C Tablets (OTC), PraziquantelTablets (Rx)


200-501 Praziquantel Injection Bimeda Animal Health Limited

200-176 Prazitech™ Bimeda Animal Health Limited

011-789 Predef® 2x Sterile Aqueous Suspension Zoetis Inc.

098-288 Prednis-A-Vet Injection Bimeda Animal Health Limited

140-921 PrednisTab® Lloyd, Inc.

141-230 Previcox® Chewable Tablets Boehringer lngelheim Animal Health USA Inc.

200-433 Pributazone® First Priority, Inc.

200-362 Priconazole™ Lotion 1% and Spray 1% First Priority, Inc.

200-321 Primectin™ Equine Oral Liquid First Priority, Inc.

140-846 PrimeX® Wildlife Laboratories, Inc.

200-445 Primex® First Priority, Inc.

200-352 Primex® 2-X, Primex® Canine First Priority, Inc.

200-353 Primex™ Equine First Priority, Inc.

009-392 Primidone Zoetis Inc.

100-929 Primor® Tablets Zoetis Inc.

055-064 Princillin Injection Zoetis Inc.

055-066 Princillin Injection Zoetis Inc.

055-071 Princillin Injection 200 mg Zoetis Inc.

033-127 Prinzone Bolus, Pyradan Bolus,Vetisulid® Bolus


033-318 Prinzone Injection, Pyradan Injection,Vetisulid® Injection


200-304 Pritox® First Priority, Inc.

200-301 Privasan™ Antiseptic Ointment First Priority, Inc.

200-340 Privermectin® First Priority, Inc.


Page:50

ApplicationNumber


200-327 Privermectin™ Drench for Sheep First Priority, Inc.

065-505 Pro-Pen-G® Bimeda Animal Health Limited

132-789 Pro-Spot Solution Elanco US Inc.

033-342 Proban® Cythioate Tablets 30 mg Zoetis Inc.

033-606 Proban® Oral Liquid Zoetis Inc.

132-336 Proban® Oral Liquid Elanco US Inc.

132-337 Proban® Tablets Elanco US Inc.

140-818 Producil® For Swine Boehringer lngelheim Animal Health USA Inc.

141-275 Profender™ Elanco US Inc.

141-062 Program® Cat Flavor Tabs™ Elanco US Inc.

141-035 Program® Flavor Tabs® Elanco US Inc.

141-205 Program® Flavor Tabs® and Capstar®Flea Management System™

Elanco US Inc.

141-105 Program™ 6 Month Injectable for Cats Elanco US Inc.

141-026 Program™ Suspension Elanco US Inc.

141-519 ProHeart® 12 Zoetis Inc.

141-189 ProHeart® 6 Zoetis Inc.

141-051 ProHeart™ Zoetis Inc.

200-225 Prohibit™ Soluble Drench Powder Huvepharma EOOD

141-517 PROIN ER™ Pegasus Laboratories, Inc.

141-324 PROIN® Chewable Tablets Pegasus Laboratories, Inc.

044-757 Prolate I-E Intervet, Inc.

117-532 PromAce® Boehringer lngelheim Animal Health USA Inc.

015-030 PromAce® Injectable Boehringer lngelheim Animal Health USA Inc.

032-702 PromAce® Tablets Boehringer lngelheim Animal Health USA Inc.

012-656 Promazine Granules Zoetis Inc.

011-241 Promazine HCl Injectable Zoetis Inc.


Page:51

ApplicationNumber


141-303 PropoClear™ Zoetis Inc.

141-098 PropoFlo™, PropoFlo™ 28 Zoetis Inc.

200-127 PROSPEC® Injectable, SpectinomycinInjectable

Zoetis Inc.

200-253 ProstaMate™ Bimeda Animal Health Limited

100-202 Prostin F2 Alpha® Sterile Solution Zoetis Inc.

013-502 Protamone-D Agri-Tech, Inc.

141-268 Protazil™ Intervet, Inc.

005-633 Protomone Thyroactive Casein Agri-Tech, Inc.

039-204 Protopam Zoetis Inc.

141-297 ProZinc® Boehringer lngelheim Animal Health USA Inc.

141-343 Pulmotil® 90 and Rumensin® 90 Elanco US Inc.

141-064 Pulmotil™ 90 Elanco US Inc.

141-361 Pulmotil™ AC Elanco US Inc.

200-655 Pulmotil™ and Monovet® Huvepharma EOOD

141-171 Purina Sugar Mag Block 1440 BVTMedicated Mineral Block

Purina Animal Nutrition LLC

092-150 Purina® Horse & Colt Wormer Bimeda Animal Health Limited

125-730 Purina® Liquid Dog Wormer Farnam Companies, Inc.

119-142 PVL Iron Dextran Injectable Huvepharma EOOD

124-241 PVL Oxytocin Injectable Bimeda Animal Health Limited

200-281 Pyrantel Pamoate Chewable Tablets Virbac AH, Inc.

200-342 Pyrantel Pamoate Paste Farnam Companies, Inc.

200-248 Pyrantel Pamoate Suspension, PyrantelPamoate Suspension-2.27mg, PyrantelPamoate Suspension-4.54mg


200-168 PyrantelCare™ Farnam Companies, Inc.

138-405 Pyrilamine Maleate Injection Bimeda Animal Health Limited

055-028 Quartermaster® Suspension HQ Specialty Pharma Corp.


Page:52

ApplicationNumber


200-555 quellin® Elanco US Inc.

141-087 Quest® Gel Zoetis Inc.

141-216 Quest® Plus Gel Zoetis Inc.

200-106 R-Pen Huvepharma EOOD

091-127 Rachelle Oxyvet Injection Zoetis Inc.

200-691 RAC™ 45 CATTLE Virbac AH, Inc.

038-233 Ralgro® Implants, Ralgro® Magnum Intervet, Inc.

141-192 Ralgro® L. A. Intervet, Inc.

141-070 Rapanofal™ iVaoes Animal Health

125-961 Re-Sorb, Vytrate Zoetis Inc.

141-240 ReBalance® Pegasus Laboratories, Inc.

141-272 Reconcile® Pegasus Laboratories, Inc.

006-417 Recovr Injectable Kinetic Technologies, LLC

131-310 Regu-Mate® Intervet, Inc.

091-192 Renografin®-76 Zoetis Inc.

091-240 Renovist Zoetis Inc.

128-967 Repose Euthanasia Solution Zoetis Inc.

141-299 Resflor Gold® Intervet, Inc.

140-992 Revalor®-200, Revalor®-H, Revalor®-IH

Intervet, Inc.

140-897 Revalor®-G, Revalor®-IS, Revalor®-S Intervet, Inc.

141-269 Revalor®-XH, Revalor®-XS Intervet, Inc.

141-445 Revalor®-XR Intervet, Inc.

200-624 REVERTIDINE™ Modern Veterinary Therapeutics, LLC

200-673 Revolt® Aurora Pharmaceutical, Inc.

141-152 Revolution® Zoetis Inc.

141-502 revolution® PLUS Zoetis Inc.


Page:53

ApplicationNumber


031-448 Rheaform Bolus Zoetis Inc.

141-326 Rilexine® Chewable Tablets Virbac AH, Inc.

141-053 Rimadyl® Caplets Zoetis Inc.

141-111 Rimadyl® Chewable Tablets Zoetis Inc.

141-199 Rimadyl® Sterile Injectable Solution Zoetis Inc.

107-346 Rintal® Suspension Elanco US Inc.

140-912 Rintal® Tabs Anthelmintic Tablets Elanco US Inc.

045-513 Ripercol L Zoetis Inc.

049-553 Ripercol L Zoetis Inc.

039-356 Ripercol L Bolus, Tramisol® CattleWormer Bolus

Zoetis Inc.

039-357 Ripercol L Soluble Drench Powder Zoetis Inc.

042-837 Ripercol L Wormer Oblets, Tramisol®Sheep Wormer Oblets

Zoetis Inc.

042-740 Ripercol L, Tramisol® Soluble DrenchPowder for Sheep

Zoetis Inc.

093-688 Ripercol L-Piperazine Zoetis Inc.

092-237 Ripercol L-Piperazine Soluble Zoetis Inc.

141-004 Robamox®-V Zoetis Inc.

141-005 Robamox®-V Tablets Zoetis Inc.

038-838 Robaxin®-V Injectable Kinetic Technologies, LLC

045-715 Robaxin®-V Tablets Zoetis Inc.

048-486 Robenz® Zoetis Inc.

092-507 Robenz® and Aureomycin® Zoetis Inc.

141-482 Robenz® and LINCOMIX® Zoetis Inc.

096-933 Robenz® Plus Zn Bacitracin Zoetis Inc.

101-777 Robinul®-V Injectable Zoetis Inc.

098-640 Robizone Injectable 20% Zoetis Inc.


Page:54

ApplicationNumber


091-065 Robizone-V Zoetis Inc.

093-105 Robizone-V Zoetis Inc.

040-209 Rofenaid® 40 Zoetis Inc.

125-933 Romet®-30 Pharmaq AS

047-955 Rompun® Injectable (20 mg) Elanco US Inc.

047-956 Rompun™ Injectable (100 mg) Elanco US Inc.

011-879 Rubrafer, Rubrafer S-100 Zoetis Inc.

092-444 Rumatel® 88 Phibro Animal Health Corp.

093-903 Rumatel® Cattle Wormer Bolus Zoetis Inc.

200-531 Rumensin® plus Tylovet® 100 Huvepharma EOOD

095-735 Rumensin™ 90 Elanco US Inc.

104-646 Rumensin™ and Tylan™ Elanco US Inc.

047-033 S.E.Z. C-R Oblets 15 Gm Zoetis Inc.

013-957 S.E.Z. Drinking Water 6.25% Zoetis Inc.

033-653 S.E.Z. Drinking Water Solution Zoetis Inc.

033-655 S.E.Z. Intravenous Solution Zoetis Inc.

033-654 S.E.Z. Oblets 15 G Zoetis Inc.

006-391 S.Q. 40% Huvepharma EOOD

200-096 Sacox® / Terramycin® Huvepharma EOOD

200-075 Sacox® 60 Huvepharma EOOD

131-675 Safe-Guard® Intervet, Inc.

139-189 Safe-Guard® Intervet, Inc.

128-620 Safe-Guard® , Panacur® Intervet, Inc.

141-449 Safe-Guard® AquaSol Intervet, Inc.

140-954 SAFE-GUARD® plus LINCOMIX® Intervet, Inc.

137-600 Safe-Guard® Type A Medicated Article Intervet, Inc.

034-621 Salix® Tablets Intervet, Inc.


Page:55

ApplicationNumber


034-478 Salix™ Injection 5% Intervet, Inc.

200-528 Savalan® 60 Huvepharma EOOD

035-016 Scolaban 400 Intervet, Inc.

111-349 SE S2 Shampoo Intervet, Inc.

200-088 Sedazine™ Boehringer lngelheim Animal Health USA Inc.

141-229 Sedivet® Boehringer lngelheim Animal Health USA Inc.

200-663 Selarid™ Norbrook Laboratories, Ltd.

200-696 SelaSpot™ Bimeda Animal Health Limited

008-422 Seleen® Suspension Boehringer lngelheim Animal Health USA Inc.

030-316 Seletoc® Injection Intervet, Inc.

030-313 Seletoc® Minicaps and Caps Intervet, Inc.

141-501 Semintra® Boehringer lngelheim Animal Health USA Inc.

200-670 SENERGY™ Chanelle Pharmaceuticals Manufacturing Ltd.

141-084 Sentinel® Flavor Tabs® Intervet, Inc.

141-204 Sentinel® Flavor Tabs® and Capstar®Flea Management System™

Intervet, Inc.

141-333 Sentinel® Spectrum® Intervet, Inc.

141-261 Sentry® HC Worm X Plus® Virbac AH, Inc.

092-710 Sergeants® Worm Away For Cats Sergeant’s Pet Care Products LLC

092-709 Sergeants® Worm Away For Dogs Sergeant’s Pet Care Products LLC

141-103 SevoFlo® Zoetis Inc.

200-467 Sevoflurane Halocarbon Products Corp.

141-456 SILEO® Orion Corp.

141-434 Simbadol™ Zoetis Inc.

141-521 Simparica Trio® Zoetis Inc.

141-452 Simparica® Zoetis Inc.

141-232 Simplicef® Zoetis Inc.


Page:56

ApplicationNumber


141-340 Skycis™ 100 Elanco US Inc.

141-260 Slentrol® Zoetis Inc.

200-434 SMZ-Med® 454 Bimeda Animal Health Limited

015-160 SODIUM SULFACHLOROPYRAZINE(MONOHYDRATE) SOLUTION,SODIUM SULFACHOROPYRAZINE(MONOHYDRATE) SOLUBLEPOWDER

Zoetis Inc.

046-790 Sodium Thiopental Zoetis Inc.

011-593 Solu-Delta Cortef® Sterile Powder Zoetis Inc.

200-122 Solu-Pen Zoetis Inc.

140-578 SOLU-TET™ Zoetis Inc.

065-280 Soluble Fortracin Concentrate Zoetis Inc.

004-536 Somnopentyl Injection Intervet, Inc.

007-981 Soxisol Tablets Zoetis Inc.

200-466 SparMectin Plus Clorsulon Sparhawk Laboratories, Inc.

200-341 SparMectin-E Sparhawk Laboratories, Inc.

200-380 SpecLinx-50® Bimeda Animal Health Limited

040-040 Spectam® Injectable Huvepharma EOOD

093-483 Spectam® Injectable Elanco US Inc.

033-157 Spectam® Scour Halt® Huvepharma EOOD

093-515 Spectam® Tablets Bimeda Animal Health Limited

041-629 Spectinomycin Oral Liquid Zoetis Inc.

015-126 Spectinomycin Tablet and Injection Zoetis Inc.

200-364 Spectogard Scour-Chek™ Bimeda Animal Health Limited

038-661 SpectoGard® Water Soluble Powder Bimeda Animal Health Limited

141-238 Spectramast® LC Sterile Suspension Zoetis Inc.

141-239 Spectramast™ DC Sterile Suspension Zoetis Inc.


Page:57

ApplicationNumber


047-138 Spotton 20% Ready-to-Use CattleInsecticide

Elanco US Inc.

091-467 Stafac® 500, Stafac® 10, Stafac® 20,Stafac® 50


141-469 Stafac® and AMPROL® Phibro Animal Health Corp.

141-470 Stafac® and Avatec® Phibro Animal Health Corp.

141-468 Stafac® and Bio-Cox® Phibro Animal Health Corp.

141-430 Stafac® and Coban™ Phibro Animal Health Corp.

141-541 STELFONTA® QBiotics Group Ltd.

130-951 Stenorol® Huvepharma EOOD

141-473 Stenorol® and LINCOMIX® Huvepharma EOOD

140-824 Stenorol® Type A Medicated Article Huvepharma EOOD

008-097 Stiglyn 1:500 Intervet, Inc.

065-252 STREP SOL® Huvepharma EOOD

200-197 Streptomycin Oral Solution Huvepharma EOOD

115-732 Stresnil Injection Elanco US Inc.

140-819 Strongid® 48 Zoetis Inc.

091-739 Strongid® T Zoetis Inc.

104-184 Styquin Zoetis Inc.

132-533 Styquin Parenteral 1.1% Elanco US Inc.

141-319 SucroMate™ Equine Thorn Bioscience LLC

006-891 Sul-Q-Nox® Huvepharma EOOD

011-532 Sulfabrom 2.5 g Boehringer lngelheim Animal Health USA Inc.

200-192 Sulfadimethoxine 12.5% Oral Solution Huvepharma EOOD

200-165 Sulfadimethoxine Concentrated Solution12.5%


200-177 Sulfadimethoxine Injection 40% Huvepharma EOOD

200-258 Sulfadimethoxine Soluble Powder Phibro Animal Health Corp.


Page:58

ApplicationNumber


200-443 Sulfadimethoxine Soluble Powder First Priority, Inc.

200-376 Sulfamed-G® Bimeda Animal Health Limited

200-523 SulfaMed™ Bimeda Animal Health Limited

033-950 SULFAMERAZINE FISH GRADE Zoetis Inc.

049-892 Sulfamethazine Spanbolet II Zoetis Inc.

140-270 Sulfamethazine Sustained Release Bolus Huvepharma EOOD

200-238 Sulfasol Soluble Powder Med-Pharmex, Inc.

005-236 Sulfodene® Medication for Dogs Farnam Companies, Inc.

200-251 Sulforal® Med-Pharmex, Inc.

140-909 Sulka-S™ Bolus Zoetis Inc.

006-084 Sulmet® Drinking Water Solution, 12.5% Huvepharma EOOD

122-271 Sulmet® Oblets Huvepharma EOOD

122-272 Sulmet® Soluble Powder Huvepharma EOOD

008-774 Sulmet® Solution Injectable Huvepharma EOOD

006-707 Sulquin® 6-50 Concentrate Zoetis Inc.

141-014 Super-Ov® Therio, Inc.

200-333 Superiorbute® Superior Equine Pharmaceuticals, Inc.

010-809 Surital Zoetis Inc.

141-298 Surolan® Elanco US Inc.

141-186 Surpass® Topical Anti-InflammatoryCream


120-615 Sustain III® Bolus, Sustain III® CalfBolus


109-471 Sweetlix Rumensin® Pressed Block Ridley USA Inc.

033-773 Sweetlix® Bloat Guard® Pressed Block Ridley USA Inc.

200-621 SwineMate® Aurora Pharmaceutical, Inc.

140-474 Synacid™ Intervet, Inc.

015-152 Synalar® Cream Veterinary Bausch Health US, LLC


Page:59

ApplicationNumber


015-298 Synalar® Solution Veterinary Bausch Health US, LLC

140-892 Synanthic® Bovine Dewormer Paste,18.5%

Zoetis Inc.

140-854 Synanthic® Bovine DewormerSuspension 22.5%, Synanthic® BovineDewormer Suspension 9.06%


100-254 Synchrocept Solution Zoetis Inc.

134-930 Syncro-Mate-B® Boehringer lngelheim Animal Health USA Inc.

045-512 Synotic® Otic Solution Zoetis Inc.

141-043 SYNOVEX Choice®, SYNOVEXPLUS®

Zoetis Inc.

009-576 Synovex® C, Synovex® S Zoetis Inc.

011-427 Synovex® H Zoetis Inc.

141-348 SYNOVEX® ONE FEEDLOT,SYNOVEX® ONE GRASS

Zoetis Inc.

200-367 Synovex® T120, Synovex® T40,Synovex® T80

Zoetis Inc.

047-334 Synsac Solution Zoetis Inc.

044-611 Talwin®-V Sterile Aqueous Injection Zoetis Inc.

141-545 TANOVEA® Elanco US Inc.

033-803 Task Dog Anthelmintic Cronus Pharma Specialities India Private Limited

048-271 Task® Tabs Cronus Pharma Specialities India Private Limited

015-875 TBZ 200 Medicated Feed Premix Boehringer lngelheim Animal Health USA Inc.

015-123 TBZ® Cattle Wormer (Drench) Boehringer lngelheim Animal Health USA Inc.

049-461 TBZ® Wormer Paste 43% Boehringer lngelheim Animal Health USA Inc.

048-487 TBZ® Wormer Paste 50% Boehringer lngelheim Animal Health USA Inc.

106-111 Telazol® Zoetis Inc.

102-987 Telmintic Powder Intervet, Inc.

118-394 Telmin® Intervet, Inc.

100-402 Telmin® B Equine Wormer Intervet, Inc.


Page:60

ApplicationNumber


138-954 Telmin® B Paste Intervet, Inc.

091-736 Telmin® Equine Wormer Intervet, Inc.

097-221 Telmin® Syringe Formula Intervet, Inc.

035-161 Temaril-P® Spansule Capsule No. 1,Temaril-P® Spansule Capsule No. 2

Zoetis Inc.

012-437 Temaril-P® Tablets Zoetis Inc.

008-622 TERRAMYCIN-343®,TERRAMYCIN®, TERRAMYCIN®Soluble Powder Concentrate

Zoetis Inc.

095-143 Terramycin® 10, Terramycin® 30,Terramycin® 50, Terramycin® 100,Terramycin® 200, Terramycin® 200Granular, Terramycin® 100MR


038-439 Terramycin® 100 for Fish, Terramycin®200 for Fish


008-763 Terramycin® Ophthalmic Ointment withPolymyxin

Zoetis Inc.

011-060 Terramycin® Scours Tablets Zoetis Inc.

007-879 Terramycin® Vet Capsules Zoetis Inc.

065-140 Tet-Sol® 10, Tet-Sol® 324 Huvepharma EOOD

200-049 Tetra-Bac® 324 Huvepharma EOOD

065-410 Tetra-Sal® Zoetis Inc.

065-069 Tetrachel-Vet Capsules 500 Zoetis Inc.

065-061 Tetrachel-Vet Drops, Tetrachel-Vet Syrup Zoetis Inc.

065-066 Tetrachel-Vet Tablets 100 Zoetis Inc.

065-124 Tetracycline Zoetis Inc.

200-136 Tetracycline HCL Powder, TetracyclineHydrochloride Soluble Powder-324

Quo Vademus, LLC

065-123 Tetracycline Soluble Powder Zoetis Inc.

065-121 Tetracycline-Vet Capsules 250 Zoetis Inc.

065-122 Tetracyn Ointment Zoetis Inc.


Page:61

ApplicationNumber


200-374 TetraMed® 324 HCA Bimeda Animal Health Limited

200-234 Tetrasol Soluble Powder Med-Pharmex, Inc.

065-496 TetraSure™ 324 Phibro Animal Health Corp.

200-146 Tetroxy® 25 Bimeda Animal Health Limited

200-247 Tetroxy® 343 Bimeda Animal Health Limited

200-460 Tetroxy® Aquatic Bimeda Animal Health Limited

200-144 Tetroxy® HCA-280, Tetroxy®HCA-1772, Tetroxy® HCA-1400


200-537 Tetroxy®-LA Bimeda Animal Health Limited

055-002 Tevcocin Cronus Pharma Specialities India Private Limited

045-416 Tevcodyne Injectable Elanco US Inc.

101-161 Thenatol PW Tablets Intervet, Inc.

039-729 Therabloat® Zoetis Inc.

200-565 Thiabendazole, Dexamethasone,Neomycin Sulfate Solution


030-103 Thibenzole (18 mg) Boehringer lngelheim Animal Health USA Inc.

013-954 Thibenzole 20% Swine Premix Boehringer lngelheim Animal Health USA Inc.

043-141 Thibenzole 300 Medicated Boehringer lngelheim Animal Health USA Inc.

035-631 Thibenzole Pig Wormer Boehringer lngelheim Animal Health USA Inc.

013-022 Thibenzole Sheep & Goat Wormer Boehringer lngelheim Animal Health USA Inc.

141-448 Thyro-Tabs® Canine Lloyd, Inc.

141-539 ThyroKare™ Neogen Corp.

200-360 Tiagard™, Tiamulin Liquid Concentrate Elanco US Inc.

200-344 TiaGard™, Tiamulin Soluble Antibiotic Phibro Animal Health Corp.

055-095 Ticillin® Zoetis Inc.

034-641 Tiguvon Pour-On Cattle Insecticide Elanco US Inc.

141-420 Tildren® Bimeda Animal Health Limited

200-509 Tilmovet® 90 Huvepharma EOOD


Page:62

ApplicationNumber


200-596 Tilmovet® 90 and Rumensin® 90 Huvepharma EOOD

200-654 Tilmovet® and Monovet® Huvepharma EOOD

037-502 Tinavet® Cream 1% Intervet, Inc.

134-645 Tiox Granules Intervet, Inc.

138-902 Tiox Paste, Tioxidazole Paste Intervet, Inc.

008-804 TM-50® , TM-50® D , TM-100® ,TM-100®D


140-448 TM® plus Bio-Cox® Phibro Animal Health Corp.

101-666 TM® plus Robenz® Phibro Animal Health Corp.

097-222 ToDAY® Boehringer lngelheim Animal Health USA Inc.

140-994 Tolazine™ Injection Akorn Animal Health, Inc.

108-114 ToMORROW® Boehringer lngelheim Animal Health USA Inc.

113-231 Topagen® Ointment Intervet, Inc.

141-290 Topmax™ 9 Elanco US Inc.

141-301 Topmax™ plus Coban® Elanco US Inc.

141-047 Torbugesic-SA® Zoetis Inc.

135-780 Torbugesic® Zoetis Inc.

102-990 Torbutrol® Injection Zoetis Inc.

103-390 Torbutrol® Tablets Zoetis Inc.

141-180 Torpex™ Boehringer lngelheim Animal Health USA Inc.

139-877 Totalon™ Topical Cattle Anthelmintic Intervet, Inc.

107-085 Tramisol® Zoetis Inc.

126-237 Tramisol® Gel Zoetis Inc.

102-437 Tramisol® Injectable Solution Zoetis Inc.

140-844 Tramisol® Pour-On Zoetis Inc.

139-858 Tramisol®-X-Tra Cattle Anthelmintic andExtoparasitic Paste

Intervet, Inc.

119-141 Tranquazine Injection Bimeda Animal Health Limited


Page:63

ApplicationNumber


041-665 Tranvet Chewable Tablets (20 mg) Zoetis Inc.

045-716 Tranvet Injectable Solution Zoetis Inc.

042-633 Tresaderm Dermatologic Solution Boehringer lngelheim Animal Health USA Inc.

141-074 Trexonil® Wildlife Laboratories, Inc.

200-338 Tri-Heart Plus Chewable Tablets Heska Corp.

200-229 Tri-Otic® Ointment Med-Pharmex, Inc.

102-020 Tri-Plex Worm Capsules Intervet, Inc.

013-624 Triamcinolone Acetonide Boehringer lngelheim Animal Health USA Inc.

138-869 Triamcinolone Acetonide Suspension Cronus Pharma Specialities India Private Limited

200-512 Triamulox™ Zoetis Inc.

095-614 Tribrissen® 120 Tablets, Tribrissen®30 Tablets, Tribrissen® 480 Tablets,Tribrissen® 960 Tablets

Intervet, Inc.

105-093 Tribrissen® 24% Injection Intervet, Inc.

131-918 Tribrissen® 400 Oral Paste Intervet, Inc.

106-965 Tribrissen® 48% Injection Intervet, Inc.

136-741 Tribrissen® 60 Oral Suspension Intervet, Inc.

141-245 Tributame™ Euthanasia Solution Cronus Pharma Specialities India Private Limited

200-226 Tricaine-S Syndel USA

141-321 Trifexis™ Elanco US Inc.

200-162 Tripelennamine Hydrochloride Injection Huvepharma EOOD

103-953 Trivermicide Worm Capsules Happy Jack, Inc.

031-555 Trypzyme® Aerosol Farnam Companies, Inc.

200-244 Tucoprim® Powder Zoetis Inc.

013-076 Tylan Soluble™ Elanco US Inc.

091-749 Tylan® 10 Sulfa-G™, Tylan® 40 Sulfa-G™

Zoetis Inc.

046-415 Tylan® 40 Zoetis Inc.


Page:64

ApplicationNumber


012-491 Tylan™ 10, Tylan™ 40, Tylan™ 100,Tylan™ 100 CAL

Elanco US Inc.

098-431 TYLAN™ 20, TYLAN™ 40 Phibro Animal Health Corp.

012-965 Tylan™ 200 Injection, Tylan™ 50Injection

Elanco US Inc.

041-275 Tylan™ 5 Sulfa-G™, Tylan™ 10 Sulfa-G™, Tylan™ 20 Sulfa-G™, Tylan™ 40Sulfa-G™

Elanco US Inc.

110-047 Tylan™ and Banminth® Phibro Animal Health Corp.

138-955 Tylosin® Injection Huvepharma EOOD

200-484 Tylovet® 40, Tylovet® 100 Huvepharma EOOD

200-473 Tylovet® Soluble Huvepharma EOOD

200-557 Tzed™ Dechra Veterinary Products LLC

141-227 UlcerGard® Boehringer lngelheim Animal Health USA Inc.

106-772 Uniferon® 100 Pharmacosmos, Inc.

134-708 Uniferon® 200 Pharmacosmos, Inc.

200-033 Uniprim™ Powder Neogen Corp.

140-998 V-Max®, V-Max® 50 Phibro Animal Health Corp.

110-048 Valbazen® Zoetis Inc.



065-276 Veesyn Granules for Oral Soln Boehringer lngelheim Animal Health USA Inc.

200-109 Velenium™ Zoetis Inc.

116-089 Veltrim 1% Dermatologic Cream Elanco US Inc.

140-973 Ventipulmin® Syrup Boehringer lngelheim Animal Health USA Inc.

141-344 Veraflox™ Elanco US Inc.

133-953 Vercom Paste Anthelmintic Elanco US Inc.

006-691 Vermiplex Intervet, Inc.

200-183 VET BETA-GEN® Med-Pharmex, Inc.


Page:65

ApplicationNumber


140-908 Veta-Meth™ Lloyd, Inc.

200-055 VetaKet® Akorn Animal Health, Inc.

046-146 Vetalog Cream Boehringer lngelheim Animal Health USA Inc.

099-388 Vetalog Oral Powder Boehringer lngelheim Animal Health USA Inc.

137-694 Vetalog® Boehringer lngelheim Animal Health USA Inc.

012-198 Vetalog® Parenteral Boehringer lngelheim Animal Health USA Inc.

011-482 Vetame Injectable, Vetame Tablets Zoetis Inc.

011-582 Vetamox Soluble Powder Zoetis Inc.

033-373 Vetisulid® Huvepharma EOOD

040-181 Vetisulid® Oral Suspension Huvepharma EOOD

033-319 Vetisulid® Tablets Boehringer lngelheim Animal Health USA Inc.

141-273 Vetmedin® Boehringer lngelheim Animal Health USA Inc.

200-682 Vetmulin® 12.5% Huvepharma EOOD

141-291 VETORYL® CAPSULES Dechra, Ltd.

200-397 Vetprofen™ Belcher Pharmaceuticals, Inc.

200-273 Vetro-Gen™ Veterinary OphthalmicOintment


200-283 Vetro-Max® Fougera Pharmaceuticals, Inc.

141-236 Vetsulin® Intervet, Inc.

055-059 Viceton® Tablets Bimeda Animal Health Limited

093-600 Voren® Suspension Boehringer lngelheim Animal Health USA Inc.

034-697 Warbex® Famphur Cattle Pour-on Intervet, Inc.

135-544 Winstrol-V® Chewable Tablets Zoetis Inc.

030-844 Winstrol-V® Sterile Suspension Zoetis Inc.

015-506 Winstrol-V® Tablets Zoetis Inc.

107-189 Worm Capsules Farnam Companies, Inc.

200-529 XylaMed™ Bimeda Animal Health Limited


Page:66

ApplicationNumber


140-442 Xylazine HCl Injection Cronus Pharma Specialities India Private Limited

140-866 Yobine® Injection Akorn Animal Health, Inc.

141-328 Zactran® Boehringer lngelheim Animal Health USA Inc.

141-151 Zeniquin® Zoetis Inc.

141-217 Zeuterin™ Ark Sciences, Inc.

141-258 Zilmax® Intervet, Inc.

141-276 Zilmax® and Rumensin™ and Tylan™ Intervet, Inc.

141-280 Zilmax® and Rumensin™ and Tylan™and MGA®

Intervet, Inc.

141-284 Zilmax® plus MGA® Intervet, Inc.

141-278 Zilmax® plus Rumensin® Intervet, Inc.

141-282 Zilmax®/Rumensin®/MGA® Intervet, Inc.

200-547 Zilmax®/Rumensin®/Tylovet® 100 Huvepharma EOOD

200-544 Zilmax®/Rumensin®/Tylovet® 100/MGA®

Huvepharma EOOD

141-241 Zimecterin-EZ™ Farnam Companies, Inc.

141-214 ZIMECTERIN® Gold Paste Boehringer lngelheim Animal Health USA Inc.

141-513 Zimeta™ Kindred Biosciences, Inc.

013-747 Zoalene 90 Medicated Coccidiostat Zoetis Inc.

141-489 Zoamix® and LINCOMIX® Zoetis Inc.

011-116 Zoamix® Type A Medicated Article Zoetis Inc.

200-690 ZoaShield™ 25% Elanco US Inc.

200-517 Zobuxa™ Elanco US Inc.

200-618 Zoletil™ for Injection Virbac AH, Inc.

128-089 Zonometh Solution Huvepharma EOOD

141-193 Zubrin™ Rapidly-Disintegrating Tablets Intervet, Inc.

141-334 Zuprevo™ Intervet, Inc.

141-444 Zycortal® Suspension Dechra, Ltd.


Documents

Green Book Section 1.1 - Trade Names and Sponsor