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 | Syndel USA 1441 West Smith Rd. 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 | Syndel USA 1441 West Smith Rd. 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 U.S. Agent: | 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 U.S. Agent: | 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 U.S. Agent: | 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 U.S. Agent: | 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 Pharmaceuticals 685 US Highway One, Suite 265 North Brunswick, NJ 08902 | Buprenorphine extended-release injectable suspension ETHIQA XR | Injectable (subcutaneous) | Captive rodents, ferrets, laboratory rabbits, and non-human primates | For the control of post-procedural pain | 7/26/2013 | 9/3/2014 6/24/2019 9/29/2023 3/29/2024 11/1/2024 11/1/2024 | FOI Summary - Mice FOI Summary - Rats FOI Summary - Ferrets FOI Summary - Non-human primates FOI Summary - Rabbits FOI Summary - Captive Rodents Product Labeling Carton Labeling Package Insert |
| 900-018 | New A Innovation Limited U.S. Agent: | 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 | Zoetis, Inc. 333 Portage Street Kalamazoo, MI 49007 | 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 | 9/11/23 New Holder | 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 |