The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species

The contact information listed on the Index may not be current. If you have questions about any of the information on the Index, please contact AskCVM@fda.hhs.gov.

MIF No.	Holder Name & Address	Generic & Trade Name	Dosage Form	Species	Intended Use	Index Entry	Modified	FOI Summary & Labeling
900-000	Wildlife Pharmaceuticals, Inc. 1230 W. Ash Street Suite D Windsor, CO 80550	Thiafentanil oxalate THIANIL	Injectable (intramuscular)	Captive non-food-producing minor species hoof stock	For immobilization of captive minor species hoof stock excluding any member of a food-producing minor species such as deer, elk, or bison and any minor species animal that may become eligible for consumption by humans or food-producing animals.	6/16/2016		FOI Summary Package Insert Product Labeling
900-001	Western Chemical Inc. 1269 Lattimore Road Ferndale, WA 98248	sGnRHa + domperidone OVAPRIM	Injectable (intraperitoneal, intramuscular)	Ornamental finfish broodstock	For use as a spawning aid in ornamental finfish broodstock	3/17/2009		FOI Summary  Product Labeling Carton Labeling Vial Labeling
900-002	Western Chemical Inc. 1269 Lattimore Road Ferndale, WA 98248	Metomidate hydrochloride AQUACALM	Soluble powder	Ornamental finfish	For the sedation and anesthesia of ornamental finfish	6/3/2009		FOI Summary Product Labeling
900-003	Wildlife Pharmaceuticals, Inc. 1230 W. Ash Street Suite D Windsor, CO 80550	Naltrexone hydrochloride TREXONIL	Injectable (intramuscular, intravenous)	Captive non-food-producing minor species hoof stock	For use as an antagonist to THIANIL (thiafentanil oxalate) immobilization of captive minor species hoof stock excluding any member of a food-producing minor species such as mule deer, elk, or bison and any minor species animal that may become eligible for consumption by humans or food-producing animals.	11/3/2016		FOI Summary Package Insert Product Labeling
900-006	Wildlife Pharmaceuticals, Inc. 1230 W. Ash Street Suite D Windsor, CO 80550	Buprenorphine extended-release injection BUPRELAB-RAT	Injectable (subcutaneous)	Rats	For the control of post-procedural pain in rats	10/28/2013		FOI Summary Product Labeling
900-007	Health and Hygiene (Pty) Ltd P.O. Box 906 Florida Hills, 1716, South Africa U.S. Agent: Kristen V. Khanna, PhD, MBA Animal Clinical Investigation, LLC 4926 Wisconsin Ave, NW Washington, D.C. 20016	Benzalkonium chloride and polyhexanide topical solution F10 brand ANTISEPTIC SOLUTION	Topical solution	Raptors, pet birds, captive small mammals, captive reptiles, and captive exotic/zoo mammals (use is prohibited in food-producing species such as rabbits, deer, ducks, pigeons, and turtles)	For the treatment and control of upper and lower respiratory tract disease associated with bacterial, fungal, or viral organisms susceptible to benzalkonium chloride and polyhexanide in raptors, pet birds, captive small mammals, and captive reptiles For use as a topical antiseptic for surface wounds on raptors, pet birds, captive small mammals, captive reptiles, and captive exotic/zoo mammals	2/6/2015		FOI Summary Product Labeling Concentrate Labeling
900-009	Health and Hygiene (Pty) Ltd P.O. Box 906 Florida Hills, 1716, South Africa U.S. Agent: Kristen V. Khanna, PhD, MBA Animal Clinical Investigation, LLC 4926 Wisconsin Ave, NW Washington, D.C. 20016	Benzalkonium chloride and polyhexanide topical ointment F10 brand ANTISEPTIC BARRIER OINTMENT	Topical ointment	Raptors, pet birds, captive small mammals, captive reptiles, and captive exotic/zoo mammals (use is prohibited in food-producing species such as rabbits, deer, ducks, pigeons, and turtles)	For the treatment of mild and localized cases of bumblefoot (pododermatitis) in caged raptors and pet birds For use as a topical antiseptic for more severe cases of bumblefoot to assist healing after surgery in caged raptors and pet birds For use as a topical antiseptic for surface wounds on raptors, pet birds, captive small mammals, captive reptiles, and captive exotic/zoo mammals	2/19/2015		FOI Summary Product Labeling - 3.5 oz Product Labeling - 17.6 oz Product Labeling - .8 oz
900-010	Health and Hygiene (Pty) Ltd P.O. Box 906 Florida Hills, 1716, South Africa U.S. Agent: Kristen V. Khanna, PhD, MBA Animal Clinical Investigation, LLC 4926 Wisconsin Ave, NW Washington, D.C. 20016	Benzalkonium chloride, polyhexanide and cypermethrin topical solution F10 brand ANTISEPTIC WOUND SPRAY WITH INSECTICIDE	Topical solution	Raptors, pet birds, captive small mammals, captive reptiles, and captive exotic/zoo mammals (use is prohibited in food-producing species such as rabbits, deer, ducks, pigeons, and turtles)	For use as a topical antiseptic for surface wounds, to repel flies, and to treat infestations due to fly strike in raptors, pet birds, captive small mammals, captive reptiles, and captive exotic/zoo mammals	2/27/2015		FOI Summary Product Labeling - 16.9 fl oz Product Labeling - 3.5 fl oz
900-011	Health and Hygiene (Pty) Ltd P.O. Box 906 Florida Hills, 1716, South Africa U.S. Agent: Kristen V. Khanna, PhD, MBA Animal Clinical Investigation, LLC 4926 Wisconsin Ave, NW Washington, D.C. 20016	Benzalkonium chloride, polyhexanide and cypermethrin topical ointment F10 brand ANTISEPTIC BARRIER OINTMENT WITH INSECTICIDE	Topical ointment	Raptors, pet birds, captive small mammals, captive reptiles, and captive exotic/zoo mammals (use is prohibited in food-producing species such as rabbits, deer, ducks, pigeons, and turtles)	For use as a topical antiseptic for surface wounds, to repel flies, and to treat infestations due to fly strike in raptors, pet birds, captive small mammals, captive reptiles, and captive exotic/zoo mammals	2/23/2015		FOI Summary Product Labeling - 3.5 oz Product Labeling - 17.6 oz Product Labeling - .8 oz
900-012	Synedgen, Inc. 1420 N. Claremont Blvd. Suite 105D Claremont, CA 91711	Poly (acetyl, arginyl) glucosamine SYNOPLEX	Soluble powder	Elephants, Rhinoceroses	For topical application for treatment of foot and dermal lesions infected with aerobic or facultative anaerobic Gram-positive and/or Gram-negative bacteria; and for treatment of sterile chronic foot and dermal lesions	6/15/2012		FOI Summary Product Labeling
900-013	Virbac AH, Inc. 3200 Meacham Blvd. Fort Worth, TX 76137	Deslorelin acetate SUPRELORIN F	Implant (subcutaneous)	Domestic ferrets	For the management of adrenal gland cortical disease	6/25/2012		FOI Summary Product Labeling Implant Labeling 2 Ct Carton Labeling 5 Ct Carton Labeling
900-014	Fidelis Animal Health, Inc. 685 US Highway One, Suite 265 North Brunswick, NJ 08902	Buprenorphine extended-release injectable suspension ETHIQA XR	Injectable (subcutaneous)	Mice, Rats, Ferrets, Non-Human Primates	For the control of post-procedural pain in mice, rats, ferrets, and non-human primates	7/26/2013	9/3/2014 Added rats to indication 6/24/2019 New Holder and Trade Name 9/29/2023 Added ferrets to indication 3/29/2024 Added non-human primates to indication	FOI Summary - Mice FOI Summary - Rats FOI Summary - Ferrets FOI Summary - Non-human primates Product Labeling Carton Labeling Package Insert
900-018	New A Innovation Limited 17/F Chevalier Commercial Centre 8 Wang Hoi Road Kowloon Bay, Kowloon Hong Kong U.S. Agent: James H. Schafer, DVM Schafer Veterinary Consultants, LLC 800 Helena Court Fort Collins, CO 80524	Hemoglobin crosfumaril (bovine) OXAPEX IDX	Injectable (intravenous, intraosseous)	Captive mustelids, captive rodents, raptors, and captive or pet birds of the orders Psittaciformes, Passeriformes, and Columbiformes, excluding squab raised for food	For the treatment of anemia; specifically hypoxemia associated with imminent anemic crisis caused by blood loss, hemolysis, or reduced hematopoiesis in captive mustelids, captive rodents, raptors, and captive or pet birds of the orders Psittaciformes, Passeriformes, and Columbiformes, excluding squab raised for food.	11/23/15		FOI Summary Product Labeling
900-020	Wildlife Pharmaceuticals, Inc. 1230 W. Ash Street Suite D Windsor, CO 80550	Buprenorphine extended-release injection BUPRELAB-MOUSE	Injectable (subcutaneous)	Mice	For the control of post-procedural pain in mice	3/30/2022		FOI Summary Package Insert Product Labeling
900-031	Jurox Pty Limited 85 Gardiner Street Rutherford, New South Wales, 2320, AS U.S. Agent: James H. Schafer, DVM Schafer Veterinary Consultants, LLC 800 Helena Court, Fort Collins, CO 80524	Alfaxalone ALFAXAN MULTIDOSE IDX	Injectable (Intravascular, Intramuscular, Subcutaneous, Intraperitoneal) Immersion	Captive reptiles, captive amphibians, ornamental fish, captive species and pet birds in the orders Psittaciformes, Passeriformes, and Columbiformes, non-human primates, captive rodents, captive mustelids, captive marsupials, captive minor species ungulates	For sedation and anesthesia in captive reptiles, excluding any food-producing species For sedation and anesthesia in captive amphibians, excluding any food-producing species For sedation and anesthesia in ornamental fish, including species used in research such as the zebra fish For sedation and anesthesia in captive species and pet birds in the orders Psittaciformes, Passeriformes, and Columbiformes, excluding any food-producing species For sedation and anesthesia in non-human primates For sedation and anesthesia in captive rodents For sedation and anesthesia in captive mustelids For sedation and anesthesia in captive marsupials For induction of anesthesia and immobilization in captive minor species ungulates, excluding any food-producing species	1/22/2020		FOI Summary Product Labeling
900-033	Wildlife Pharmaceuticals, Inc. 1230 W. Ash Street Suite D Windsor, CO 80550	Meloxicam extended-release injection MELOXILAB-RAT	Injectable (subcutaneous)	Rats	For the control of post-procedural pain in rats	3/24/2022		FOI Summary Package Insert Product Labeling