Oral Dosage Form New Animal Drugs; Phenylbutazone Tablets and Boluses
other · Food and Drug Administration · Rule · Published 2009-01-12 · Effective 2009-01-12 · 74 FR 1146
Document
Document number
E9-265
Federal Register citation
74 FR 1146
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2009-01-12
Effective date
2009-01-12
HHS docket
Docket No. FDA-2008-N-0039
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 First Priority, Inc. The supplemental application provides for revising the description of a 1-gram oral dosage form of phenylbutazone from tablet to bolus.