Public Master Files (PMFs) supporting approved New Animal Drug Applications (NADAs)

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PMF#	Drug/Dosage Form/ Route of Administration	Species and Indication	INAD Sponsor(s)	(A)NADA FOI Summary	Animal Drugs @ FDA
003-543	Formalin/Liquid/Aquatic exposure	Control of parasites on salmon, trout, catfish, largemouth bass, and bluegill	USFWS Aquatic Animal Drug Approval Partnership	NADA FOI 140-831	NADA 140-831
003-543	Formalin/ Liquid/ Aquatic exposure	Control of fungi on salmon, trout, and esocid eggs	USFWS Aquatic Animal Drug Approval Partnership	NADA FOI 140-831	NADA 140-831
003-543	Formalin/ Liquid/ Aquatic exposure	Control of external parasites on all finfish	USFWS Aquatic Animal Drug Approval Partnership	NADA FOI 137-687 NADA FOI 140-989 ANADA FOI 200-414	NADA 137-687 NADA 140-989 ANADA 200-414
003-543	Formalin/ Liquid/ Aquatic exposure	Control of fungi on all finfish eggs.	USFWS Aquatic Animal Drug Approval Partnership	NADA FOI 137-687 NADA FOI 140-989 ANADA FOI 200-414	NADA 137-687 NADA 140-989 ANADA 200-414
003-543	Formalin/ Liquid/ Aquatic exposure	Control of external protozoan parasites on cultured shrimp	USFWS Aquatic Animal Drug Approval Partnership	NADA FOI 137-687 NADA FOI 140-989 ANADA FOI 200-414	NADA 137-687 NADA 140-989 ANADA 200-414
003-857	Thiabendazole/ Type A Medicated Article/ Oral	Treatment of gapeworms in pheasants	USDA Minor Use Animal Drug Program	NADA FOI 015-875	NADA 015-875
003-887	Amprolium/Type A Medicated Article/ Oral	Prevention of coccidiosis in pheasants	USDA Minor Use Animal Drug Program	NADA FOI 012-350	NADA 012-350
003-895	Ivermectin/ Solution/ Injection	Treatment and control of warbles in reindeer	USDA Minor Use Animal Drug Program	NADA FOI 128-409 ANADA FOI 200-228 ANADA FOI 200-437 ANADA FOI 200-447	NADA 128-409 ANADA 200-228 ANADA 200-437 ANADA 200-447
005-012	Decoquinate/ Type A Medicated Article /Oral	Prevention of coccidiosis in goats	USDA Minor Use Animal Drug Program	NADA FOI 039-417	NADA 039-417
005-014	Monensin Sodium/ Type A Medicated Article/ Oral	Prevention of coccidiosis in quail	USDA Minor Use Animal Drug Program	NADA FOI 038-878 NADA FOI 130-736	NADA 038-878 NADA 130-736
005-020	Salinomycin/ Type A Medicated Article/ Oral	Prevention of coccidiosis in quail	USDA Minor Use Animal Drug Program	NADA FOI 128-686 ANADA FOI 200-075	NADA 128-686 ANADA 200-075
005-028	Oxytetracycline dihydrate/ Type A Medicated Article/ Oral	Control of gaffkemia in lobster	USDA Minor Use Animal Drug Program	NADA FOI 038-439	NADA 038-439
005-042	Lasalocid Sodium/ Type A Medicated Article/ Oral	Prevention of coccidiosis in rabbits	USDA Minor Use Animal Drug Program	NADA FOI 096-298	NADA 096-298
005-055	Monensin Sodium/ Type A Medicated Article/ Oral	Prevention of coccidiosis in goats	USDA Minor Use Animal Drug Program	NADA FOI 095-735	NADA 095-735
005-056	Sulfadimethoxine Ormetoprim/ Type A Medicated Article/ Oral	Control of bacterial disease in catfish	USDA Minor Use Animal Drug Program	NADA FOI 125-933	NADA 125-933
005-059	Ivermectin/Solution / Injection	Treatment and control of grubs (Hypoderma bovis) in American Bison	USDA Minor Use Animal Drug Program	NADA FOI 128-409 ANADA FOI 200-228 ANADA FOI 200-437 ANADA FOI 200-447	NADA 128-409 ANADA 200-228 ANADA 200-437 ANADA 200-447
005-071	Fenbendazole/ Type A Medicated Article, Type B Medicated feed/ Oral	Treatment and control of lungworms in bighorn sheep	USDA Minor Use Animal Drug Program	NADA FOI 131-675	NADA 131-675
005-118	Fenbendazole/ Suspension/ Oral	Removal and control of stomach and intestinal worms in goats	USDA Minor Use Animal Drug Program	NADA FOI 128-620	NADA 128-620
005-157	Sulfadimethoxine and Ormetoprim/ Type A Med. Article/ Oral	Prevention of coccidiosis in chukar partridges	USDA Minor Use Animal Drug Program	NADA FOI 040-209	NADA 040-209
005-178	Bactracin Methylene Disalicylate/ Type A Medicated Article/ Oral	Prevention of ulcerative enteritis in growing quail	USDA Minor Use Animal Drug Program	NADA FOI 046-592	NADA 046-592
005-228	Formalin / Liquid/ Aquatic exposure	Control of external parasites on all finfish	USDA Minor Use Animal Drug Program	NADA FOI 137-687 NADA FOI 140-989 ANADA FOI 200-414	NADA 137-687 NADA 140-989 ANADA 200-414
005-228	Formalin / Liquid/ Aquatic exposure	Control of fungi on all finfish eggs	USDA Minor Use Animal Drug Program	NADA FOI 137-687 NADA FOI 140-989 ANADA FOI 200-414	NADA 137-687 NADA 140-989 ANADA 200-414
005-228	Formalin / Liquid/ Aquatic exposure	Control of protozoan parasites on penaeid shrimp	USDA Minor Use Animal Drug Program	NADA FOI 137-687 NADA FOI 140-989 ANADA FOI 200-414	NADA 137-687 NADA 140-989 ANADA 200-414
005-228	Formalin / Liquid/ Aquatic exposure	Control of mortality in freshwater-reared finfish due to saprolegniasis associated with fungi in the family Saprolegniaceae	USGS Upper Midwest Environmental Sciences Center	NADA FOI 140-989	NADA 140-989
005-258	Decoquinate/ Type A Medicated Article/ Oral	Prevention of coccidiosis in sheep	USDA Minor Use Animal Drug Program	NADA FOI 039-417	NADA 039-417
005-307	Ivermectin/ Solution/ Injection	Treatment and control of ear mites on foxes	USDA Minor Use Animal Drug Program	NADA FOI 128-409	NADA 128-409
005-366	Morantel Tartrate/ Type A Medicated article/ Oral	Removal and control of gastrointestinal nematode in goats	USDA Minor Use Animal Drug Program	NADA FOI 092-444	NADA 092-444
005-429	Lasalocid Sodium/ Type A Medicated Article/ Oral	Prevention of coccidiosis in chukar partridges	USDA Minor Use Animal Drug Program	NADA FOI 096-298	NADA 096-298
005-544	Ceftiofur Sodium/ Solution/ Injection	Treatment of sheep respiratory disease	USDA Minor Use Animal Drug Program	NADA FOI 140-338	NADA 140-338
005-582	Albendazole/ Suspension/ Oral	Treatment of adult liver flukes in non-lactating goats	USDA Minor Use Animal Drug Program	NADA FOI 110-048	NADA 110-048
005-637	Chloramine-T/ water soluble powder/ Aquatic Exposure	Control of mortality in freshwater-reared salmonids due to bacterial gill disease associated with Flavobacterium spp.	USGS Upper Midwest Environmental Sciences Center	NADA FOI 141-423	NADA 141-423
005-637	Chloramine-T/ water soluble powder/ Aquatic Exposure	Control of mortality in walleye due to external columnaris disease associated with Flavobacterium columnare	USGS Upper Midwest Environmental Sciences Center	NADA FOI 141-423	NADA 141-423
005-637	Chloramine-T/ water soluble powder/ Aquatic Exposure	Control of mortality in freshwater-reared warmwater finfish due to external columnaris disease associated with Flavobacterium columnare	USGS Upper Midwest Environmental Sciences Center	NADA FOI 141-423	NADA 141-423
005-639	Hydrogen Peroxide/ Liquid/ Aquatic exposure	Control of columnaris disease in catfish and coolwater finfish	USGS Upper Midwest Environmental Sciences Center	NADA FOI 141-255	NADA 141-255
005-639	Hydrogen Peroxide/ Liquid/ Aquatic exposure	Control of bacterial gill disease in salmonids	USGS Upper Midwest Environmental Sciences Center	NADA FOI 141-255	NADA 141-255
005-639	Hydrogen Peroxide/ Liquid/ Aquatic exposure	Control of saprolegniasis in freshwater-reared finfish eggs	USGS Upper Midwest Environmental Sciences Center	NADA FOI 141-255	NADA 141-255
005-639	Hydrogen Peroxide/ Liquid/ Aquatic exposure	Control of mortality in freshwater-reared coldwater finfish, fingerling and adult freshwater-reared coolwater finfish, and fingerling and adult freshwater-reared warmwater finfish due to saprolegniasis associated with fungi in the family Saprolegniaceae.	USGS Upper Midwest Environmental Sciences Center	NADA FOI 141-255	NADA 141-255
005-639	Hydrogen Peroxide/ Liquid/ Aquatic exposure	Treatment and control of Gyrodactylus spp. in freshwater-reared salmonids	USFWS Aquatic Animal Drug Approval Partnership USGS Upper Midwest Environmental Sciences Center	NADA FOI 141-255	NADA 141-255
005-639	Hydrogen Peroxide/ Liquid/ Aquatic exposure	Control of mortality in freshwater-reared warmwater finfish due to external columnaris disease associated with Flavobacterium columnare	USFWS Aquatic Animal Drug Approval Partnership USGS Upper Midwest Environmental Sciences Center	NADA FOI 141-255	NADA 141-255
005-667	Oxytetracycline hydrochloride/ Water soluble powder/Aquatic exposure	Skeletal marking of finfish fry and fingerlings	USDA Minor Use Animal Drug Program	NADA FOI 130-435 NADA FOI 008-622 ANADA FOI 200-247 ANADA FOI 200-460	NADA 130-435 NADA 008-622 ANADA 200-247 ANADA 200-460
005-671	Ceftiofur Sodium/ Solution/ Injection	Treatment of caprine respiratory disease in goats	USDA Minor Use Animal Drug Program	NADA FOI 140-338	NADA 140-338
005-673	Tilmicosin Phosphate/ Liquid/ Injection	Treatment of ovine respiratory disease in sheep	USDA Minor Use Animal Drug Program	NADA FOI 140-929	NADA 140-929
005-783	Tylosin Tartrate/ Powder/ Oral	Control of American foulbrood in honey bees	USDA Minor Use Animal Drug Program	NADA FOI 013-076 ANADA FOI 200-473 ANADA FOI 200-455	NADA 013-076 ANADA 200-473 ANADA 200-455
005-893	Chloramine-T/ water soluble powder/ Aquatic Exposure	Control of mortality in freshwater-reared salmonids due to bacterial gill disease associated with Flavobacterium spp.	USFWS Aquatic Animal Drug Approval Partnership	NADA FOI 141-423	NADA 141-423
005-893	Chloramine-T/ water soluble powder/ Aquatic Exposure	Control of mortality in walleye due to external columnaris disease associated with Flavobacterium columnare	USFWS Aquatic Animal Drug Approval Partnership	NADA FOI 141-423	NADA 141-423
005-893	Chloramine-T/ water soluble powder/ Aquatic Exposure	Control of mortality in freshwater-reared warmwater finfish due to external columnaris disease associated with Flavobacterium columnare	USFWS Aquatic Animal Drug Approval Partnership	NADA FOI 141-423	NADA 141-423
005-927	Oxytetracycline Dihydrate/ Type A Medicated article/ Oral	Control of coldwater disease in freshwater-reared salmonids	USFWS Aquatic Animal Drug Approval Partnership	NADA FOI 038-439	NADA 038-439
005-927	Oxytetracycline Dihydrate/ Type A Medicated article/ Oral	Control of columnaris disease in freshwater-reared Oncorhynchus mykiss	USFWS Aquatic Animal Drug Approval Partnership	NADA FOI 038-439	NADA 038-439
005-927	Oxytetracycline Dihydrate/ Type A Medicated article/ Oral	Marking the skeletal tissue of freshwater-reared salmonids weighing up to 55 grams	USFWS Aquatic Animal Drug Approval Partnership	NADA FOI 038-439	NADA 038-439
005-932	Florfenicol/ Type A Medicated Article/ Oral	Control of furunculosis in freshwater-reared salmonids	USFWS Aquatic Animal Drug Approval Partnership	NADA FOI 141-246	NADA 141-246
005-932	Florfenicol/ Type A Medicated Article/ Oral	Control of coldwater disease in freshwater-reared salmonids	USFWS Aquatic Animal Drug Approval Partnership	NADA FOI 141-246	NADA 141-246
005-947	Progesterone/ Implant/ Solid Matrix	Induction of estrus in ewes (sheep)	USDA Minor Use Animal Drug Program	NADA FOI 141-302	NADA 141-302
005-988	Lincomycin Hydrochloride/ water soluble powder/ Oral	Control of American Foulbrood in honey bees	USDA Minor Use Animal Drug Program	NADA FOI 111-636	NADA 111-636