• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Animal & Veterinary

  • Print
  • Share
  • E-mail

Abbreviated New Animal Drug Approvals - January/February 2004

FDA Veterinarian Newsletter January/February 2004 Volume XIX, No 1

Company
Generic and (Brand) Names
Indications
Routes/Remarks 

Cross Vetpharm Group, Ltd.
(ANADA 200-312)
Dexamethasone injectable solution (DEXIUM) Rx
Dogs, Cats, Cattle, and Horses. For the treatment of primary bovine ketosis and as an anti-inflammatory agent in dogs, cats, cattle, and horses.

INJECTABLE— The ANADA provides for the veterinary prescription use of dexamethasone injectable solution for the treatment of primary bovine ketosis and as an anti-inflammatory agent in dogs, cats, cattle, and horses. Cross Vetpharm Group's DEXIUM Solution is approved as a generic copy of Schering-Plough Animal Health's AZIUM Solution 2 milligrams, approved under NADA 12-559.

Federal Register  11/19/03

Norbrook Laboratories, Ltd.
(ANADA 200-308)
Flunixin Injection Rx
Horses, Beef cattle, and Non-lactating Dairy Cattle. For the control of inflammation.

INJECTABLE— The ANADA provides for the veterinary prescription use of flunixin meglumine injectable solution for the control of inflammation in horses, beef cattle, and non-lactating dairy cattle. Norbrook Laboratories' Flunixin Injection is approved as a generic copy of Schering-Plough Animal Health's BANAMINE (flunixin) Solution, approved under NADA 101-479.

Federal Register  12/19/03