Oral Dosage Form New Animal Drugs; Fenbendazole Granules
other · Food and Drug Administration · Rule · Published 2006-04-14 · Effective 2006-04-14 · 71 FR 19429
Document
Document number
06-3586
Federal Register citation
71 FR 19429
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2006-04-14
Effective date
2006-04-14
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 minor changes to the labeling of over-the-counter fenbendazole granules, used for the treatment and control of certain internal parasites in dogs.