Oral Dosage Form New Animal Drugs; Phenylbutazone Paste
other · Food and Drug Administration · Rule · Published 2007-10-25 · Effective 2007-10-25 · 72 FR 60550
Document
Document number
E7-21054
Federal Register citation
72 FR 60550
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2007-10-25
Effective date
2007-10-25
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Luitpold Pharmaceuticals, Inc. The supplemental NADA provides for a revised human food safety warning for phenylbutazone paste, used in horses for relief of inflammatory conditions associated with the musculoskeletal system.