Implantation or Injectable Dosage Form New Animal Drugs; Phenylbutazone Injection
other · Food and Drug Administration · Rule · Published 2005-08-17 · Effective 2005-08-17 · 70 FR 48272
Document
Document number
05-16240
Federal Register citation
70 FR 48272
CFR reference
21 CFR 522
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2005-08-17
Effective date
2005-08-17
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 Sparhawk Laboratories, Inc. The ANADA provides for the veterinary prescription use of phenylbutazone injectable solution in horses for relief of inflammatory conditions associated with the musculoskeletal system.