Oral Dosage Form New Animal Drugs; Fenbendazole Suspension
other · Food and Drug Administration · Rule · Published 2009-04-17 · Effective 2009-04-17 · 74 FR 17770
Document
Document number
E9-8822
Federal Register citation
74 FR 17770
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2009-04-17
Effective date
2009-04-17
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 Intervet, Inc. The supplemental NADA provides for a revised human food safety warning for use of fenbendazole suspension in horses.