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 |
005-644 | fenbendazole/ Type A medicated article/ Oral | Treatment and control of Aulonocephalus spp. in wild quail | USDA Minor Use Animal Drug Program | NADA FOI 131-675 | NADA 131-675 |
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 |