Abbreviated New Animal Drug Approvals 2004

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Abbreviated New Animal Drug Approvals

• Company
• Generic and (Brand) Names
• Indications
• Routes/Remarks?Create

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

See also FDA And Animals and other animal related topics:

• [BSE Cow in U.S. Triggers FDA, USDA Cooperative Response, New Rules Announced]?Create
• BSE in the U.S. Timeline of Significant Events
• President's Fiscal Year 2005 Budget Would Increase BSE Funding
• BSE and the Safety of Pets
• FDA Hosts International BSE Discussions
• FDA Regulatory Activities 2004
• CVM Scientists Develop PCR Test to Determine Source of Animal Products in Feed, Pet Food
• Ask CVM
• FDA Releases Jan. 23 Figures on Compliance With BSE Rule
• Food Additive Regulations Amended Formaldehyde
• New Animal Drug Approvals 2004
• Supplemental New Animal Drug Approvals 2004
• Abbreviated New Animal Drug Approvals 2004
• Supplemental Abbreviated New Animal Drug Approvals 2004

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