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HomeMarket ReportsAnimal Health Drug Approvals by US FDA till July 2025

Animal Health Drug Approvals by US FDA till July 2025

DateApplication NumberSponsorProduct NameSpecies
July 21, 2025200-817Felix Pharmaceuticals Pvt. Ltd.Meloxicam Oral Suspension Dogs
July 18, 2025200-759ZyVet Animal Health, Inc. Furosemide TabletsDogs and Cats
July 17, 2025141-607Intervet, Inc. Exzolt™ (fluralaner oral solution) Chickens, laying hens and replacement chickens
July 11, 2025200-816Cronus Pharma Specialities India Private Ltd.Meloxisol™
(meloxicam oral suspension)
Dogs
July 10, 2025141-599Intervet, Inc.BRAVECTO® QUANTUM
(fluralaner for extended-release injectable suspension)
Dogs
July 8, 2025 200-815Felix Pharmaceuticals Pvt. Ltd.Cefpodoxime Proxetil TabletsDogs
July 8, 2025200-808Huvepharma EOODMGA® and Experior™ and Monovet® and Tylovet®
(melengestrol acetate Type A medicated article) and (lubabegron Type A medicated article) and (monensin Type A medicated article) and (tylosin phosphate Type A medicated article)
Growing beef heifers fed in confinement for slaughter
July 8, 2025200-807Huvepharma EOOD MGA® and Experior™ and Monovet®
(melengestrol acetate Type A medicated article) and (lubabegron Type A medicated article) and (monensin Type A medicated article)
Growing beef heifers fed in confinement for slaughter
June 27, 2025200-814Felix Pharmaceuticals Pvt. Ltd.Methimazole Coated TabletsCats
June 27, 2025200-813Felix Pharmaceuticals Pvt. Ltd.Clindamycin Hydrochloride TabletsDogs
June 24, 2025200-812Qilu Animal Health Products Co., Ltd.Cefovecin Sodium for InjectionDogs and Cats
May 21, 2025141-581Elanco US Inc.Credelio Quattro™  (lotilaner, moxidectin, praziquantel, and pyrantel chewable tablets)Dogs
April 29, 2025  141-600Intervet, Inc.Mometamax Single™ (gentamicin, posaconazole, and mometasone furoate otic suspension)Dogs
April 29, 2025    141-609Genus plcDELETION OF EXON 7 OF CD163 GENE IN DOMESTIC PIGSDomestic Pigs
April 24, 2025200-802Huvepharma EOODPennitracin MD® and Coxidin® (bacitracin Type A medicated article and monensin Type A medicated article)Growing turkeys
April 24, 2025    200-801Huvepharma EOODInteprity™ and Coxidin® (avilamycin Type A medicated article and monensin Type A medicated article)Broiler chickens
April 24, 2025    200-800Huvepharma EOODCoxidin® and Flavomycin® (monensin Type A medicated article and bambermycins Type A medicated article)Growing turkeys
April 24, 2025    200-799Huvepharma EOODCoxidin® and BMD® (monensin Type A medicated article and bacitracin methylenedisalicylate Type A medicated article)Growing turkeys
April 24, 2025    200-798Huvepharma EOOD
April 24, 2025    200-797Huvepharma EOODCoxidin® and BMD® (monensin Type A medicated article and bacitracin methylenedisalicylate Type A medicated article)Broiler chickens
April 23, 2025    141-554Boehringer Ingelheim Animal Health USA, Inc.NexGard® PLUS  (afoxolaner, moxidectin, and pyrantel chewable tablets)Dogs
April 10, 2025141-598Dechra, Ltd.Otiserene® (marbofloxacin, terbinafine, and dexamethasone otic suspension)Dog
April 8, 2025  141-587Phibro Animal Health Corp.Optaflexx™ and Rumensin™ and V-Max® (ractopamine hydrochloride Type A medicated article and monensin Type A medicated article and virginiamycin)Cattle/growing beef steers and heifers fed in confinement for slaughter
April 8, 2025141-521Zoetis Inc.Simparica TRIO®  (sarolaner, moxidectin, and pyrantel chewable tablets)Dogs
April 7, 2025141-588Phibro Animal Health Corp.Rumensin™ and V-Max® (monensin Type A medicated article and virginiamycin)Cattle/growing beef steers and heifers fed in confinement for slaughter
April 7, 2025141-586Phibro Animal Health Corp.Experior™ and Rumensin™ and V-Max® (lubabegron Type A medicated article and monensin Type A medicated article and virginiamycin)Cattle/growing beef steers and heifers fed in confinement for slaughter
April 3, 2025200-791Cronus Pharma Specialities India Private Ltd.Flunine-S™  (flunixin meglumine injection)Swine
March 14, 2025NADA 141-604TriviumVetfelycin-CA1 (sirolimus delayed-release tablets)Cats
February 25, 2025ANADA 200-742Hikma Pharmaceuticals USA, Inc.Tulathromycin InjectionBeef cattle, non-lactating dairy cattle, suckling calves, dairy calves, veal calves, and swine
January 13, 2025ANADA 200-626Bimeda Animal Health Ltd.Eprimectin Pour-On (eprinomectin)Beef and dairy cattle, including lactating dairy cattle

Source- US FDA sitel https://www.fda.gov/animal-veterinary/approved-animal-drug-products-green-book/recent-animal-drug-approvals

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