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  5. The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
  1. Minor Use/Minor Species

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

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
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

508 Compliant 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

508 Compliant Labeling
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

508 Compliant Labeling
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

508 Compliant Labeling
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
900-014 Fidelis Pharmaceuticals
675 US Hwy 1
North Brunswick, NJ 08902
Buprenorphine extended-release injectable suspension

ETHIQA XR
Injectable (subcutaneous) Mice, Rats For the control of post-procedural pain in mice and rats 7/26/2013 9/3/2014
Added rats to indication

6/24/2019
New Holder and Trade Name
FOI Summary - Mice

FOI Summary - Rats

Product labeling
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