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  1. Development & Approval Process

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

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 USDI FISH AND WILDLIFE SERVICES NADA FOI 140-831 NADA 140-831
003-543 Formalin/ Liquid/ Aquatic exposure Control of fungi on salmon, trout, and esocid eggs USDI FISH AND WILDLIFE SERVICES NADA FOI 140-831 NADA 140-831
003-543 Formalin/ Liquid/ Aquatic exposure Control of external parasites on all finfish USDI FISH AND WILDLIFE SERVICES 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. USDI FISH AND WILDLIFE SERVICES 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 USDI FISH AND WILDLIFE SERVICES 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 NRSP-7 NADA FOI 015-875 NADA 015-875
003-887 Amprolium/Type A Medicated Article/ Oral Prevention of coccidiosis in pheasants NRSP-7 NADA FOI 012-350 NADA 012-350
003-895 Ivermectin/ Solution/ Injection Treatment and control of warbles in reindeer NRSP-7 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 NRSP-7 NADA FOI 039-417 NADA 039-417
005-014 Monensin Sodium/ Type A Medicated Article/ Oral Prevention of coccidiosis in quail NRSP-7 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 NRSP-7 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 NRSP-7 NADA FOI 038-439 NADA 038-439
005-042 Lasalocid Sodium/ Type A Medicated Article/ Oral Prevention of coccidiosis in rabbits NRSP-7 NADA FOI 096-298 NADA 096-298
005-055 Monensin Sodium/ Type A Medicated Article/ Oral Prevention of coccidiosis in goats NRSP-7 NADA FOI 095-735 NADA 095-735
005-056 Sulfadimethoxine Ormetoprim/ Type A Medicated Article/ Oral Control of bacterial disease in catfish NRSP-7 NADA FOI 125-933 NADA 125-933
005-059 Ivermectin/Solution / Injection Treatment and control of grubs (Hypoderma bovis) in American Bison NRSP-7 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 NRSP-7 NADA FOI 131-675 NADA 131-675
005-118 Fenbendazole/ Suspension/ Oral Removal and control of stomach and intestinal worms in goats NRSP-7 NADA FOI 128-620 NADA 128-620
005-157 Sulfadimethoxine and Ormetoprim/ Type A Med. Article/ Oral Prevention of coccidiosis in chukar partridges NRSP-7 NADA FOI 040-209 NADA 040-209
005-178 Bactracin Methylene Disalicylate/ Type A Medicated Article/ Oral Prevention of ulcerative enteritis in growing quail NRSP-7 NADA FOI 046-592 NADA 046-592
005-228 Formalin / Liquid/ Aquatic exposure Control of external parasites on all finfish NRSP-7 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 NRSP-7 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 NRSP-7 NADA FOI 137-687
NADA FOI 140-989
ANADA FOI 200-414
 
NADA 137-687
NADA 140-989
ANADA 200-414
 
005-258 Decoquinate/ Type A Medicated Article/ Oral Prevention of coccidiosis in sheep NRSP-7 NADA FOI 039-417 NADA 039-417
005-307 Ivermectin/ Solution/ Injection Treatment and control of ear mites on foxes NRSP-7 NADA FOI 128-409 NADA 128-409
005-366 Morantel Tartrate/ Type A Medicated article/ Oral Removal and control of gastrointestinal nematode in goats NRSP-7 NADA FOI 092-444 NADA 092-444
005-429 Lasalocid Sodium/ Type A Medicated Article/ Oral Prevention of coccidiosis in chukar partridges NRSP-7 NADA FOI 096-298 NADA 096-298
005-544 Ceftiofur Sodium/ Solution/ Injection Treatment of sheep respiratory disease NRSP-7 NADA FOI 140-338 NADA 140-338
005-582 Albendazole/ Suspension/ Oral Treatment of adult liver flukes in non-lactating goats NRSP-7 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. USDI US GEOLOGICAL SURVEY 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 USDI US GEOLOGICAL SURVEY 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 USDI US GEOLOGICAL SURVEY NADA FOI 141-423 NADA 141-423
005-639 Hydrogen Peroxide/ Liquid/ Aquatic exposure Control of columnaris disease in catfish and coolwater finfish USDI US GEOLOGICAL SURVEY NADA FOI 141-255 NADA 141-255
005-639 Hydrogen Peroxide/ Liquid/ Aquatic exposure Control of bacterial gill disease in salmonids USDI US GEOLOGICAL SURVEY NADA FOI 141-255 NADA 141-255
005-639 Hydrogen Peroxide/ Liquid/ Aquatic exposure Control of saprolegniasis in freshwater-reared finfish eggs USDI US GEOLOGICAL SURVEY NADA FOI 141-255 NADA 141-255
005-667 Oxytetracycline hydrochloride/ Water soluble powder/Aquatic exposure Skeletal marking of finfish fry and fingerlings NRSP-7 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 NRSP-7 NADA FOI 140-338 NADA 140-338
005-673 Tilmicosin Phosphate/ Liquid/ Injection Treatment of ovine respiratory disease in sheep NRSP-7 NADA FOI 140-929 NADA 140-929
005-783 Tylosin Tartrate/ Powder/ Oral Control of American foulbrood in honey bees NRSP-7 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. USDI FISH AND WILDLIFE SERVICE 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 USDI FISH AND WILDLIFE SERVICE 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 USDI FISH AND WILDLIFE SERVICE NADA FOI 141-423 NADA 141-423
005-927 Oxytetracycline Dihydrate/ Type A Medicated article/ Oral Control of coldwater disease in freshwater-reared salmonids USDI FISH AND WILDLIFE SERVICE 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 USDI FISH AND WILDLIFE SERVICE NADA FOI 038-439 NADA 038-439
005-932 Florfenicol/ Type A Medicated Article/ Oral Control of furunculosis in freshwater-reared salmonids USDI FISH AND WILDLIFE SERVICE NADA FOI 141-246 NADA 141-246
005-932 Florfenicol/ Type A Medicated Article/ Oral Control of coldwater disease in freshwater-reared salmonids USDI FISH AND WILDLIFE SERVICE NADA FOI 141-246 NADA 141-246
005-947 Progesterone/ Implant/ Solid Matrix Induction of estrus in ewes (sheep) NRSP-7 NADA FOI 141-302 NADA 141-302
005-988 Lincomycin Hydrochloride/ water soluble powder/ Oral Control of American Foulbrood in honey bees NRSP-7 NADA FOI 111-636 NADA 111-636