Implantation or Injectable Dosage Form New Animal Drugs; Flunixin Meglumine
other · US Department of Health and Human Services · Rule · Published 1995-09-20 · Effective 1995-09-20 · 60 FR 48650
Document
Document number
95-23245
Federal Register citation
60 FR 48650
CFR reference
21 CFR 522
Type
Rule
Action
Final rule.
Category
other
Sub-agency
US Department of Health and Human Services
Publication date
1995-09-20
Effective date
1995-09-20
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Fort Dodge Laboratories. The ANADA provides for intravenous or intramuscular use of flunixin meglumine injection for alleviation of inflammation and pain associated with musculoskeletal disorders and visceral pain associated with colic in horses.