Oral Dosage Form New Animal Drugs; Phenylbutazone Tablets and Boluses
other · Food and Drug Administration · Rule · Published 2001-03-12 · Effective 2001-03-12 · 66 FR 14316
Document
Document number
01-5681
Federal Register citation
66 FR 14316
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2001-03-12
Effective date
2001-03-12
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 Phoenix Scientific, Inc. The supplemental NADA provides for oral use of a 200-milligram (mg) strength phenylbutazone tablet for relief of inflammatory conditions associated with the musculoskeletal system in dogs and horses.