Ophthalmic and Topical Dosage Form New Animal Drugs; Diclofenac
other · Food and Drug Administration · Rule · Published 2009-09-16 · Effective 2009-09-16 · 74 FR 47435
Document
Document number
E9-22292
Federal Register citation
74 FR 47435
CFR reference
21 CFR 524
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2009-09-16
Effective date
2009-09-16
HHS docket
Docket No. FDA-2009-N-0665
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 Boehringer Ingelheim Vetmedica, Inc. The supplemental NADA provides for a revised human food safety warning for use of diclofenac sodium topical cream in horses.