Oral Dosage Form New Animal Drugs; Phenylbutazone Paste
other · Food and Drug Administration · Rule · Published 2003-07-25 · Effective 2003-07-25 · 68 FR 43925
Document
Document number
03-18910
Federal Register citation
68 FR 43925
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2003-07-25
Effective date
2003-07-25
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 Bioniche Animal Health USA, Inc. The ANADA provides for oral use of phenylbutazone paste in horses for relief of inflammatory conditions associated with the musculoskeletal system.