Oral Dosage Form New Animal Drugs; Phenylbutazone Tablets and Boluses
other · Food and Drug Administration · Rule · Published 2003-07-10 · Effective 2003-07-10 · 68 FR 41065
Document
Document number
03-17439
Federal Register citation
68 FR 41065
CFR reference
21 CFR 510
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2003-07-10
Effective date
2003-07-10
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 West-Ward Pharmaceutical Corp. The ANADA provides for oral use of phenylbutazone tablets in horses for relief of inflammatory conditions associated with the musculoskeletal system.