Implantation or Injectable Dosage Form New Animal Drugs; Flunixin
other · Food and Drug Administration · Rule · Published 2009-02-12 · Effective 2009-02-12 · 74 FR 6993
Document
Document number
E9-2941
Federal Register citation
74 FR 6993
CFR reference
21 CFR 522
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2009-02-12
Effective date
2009-02-12
HHS docket
Docket No. FDA-2008-N-0039
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Cross Vetpharm Group Ltd. The supplemental ANADA provides for the veterinary prescription use of flunixin meglumine solution by intravenous injection in dairy cattle for control of pyrexia associated with acute bovine mastitis.