Oral Dosage Form New Animal Drugs; Fenbendazole Suspension
other · Food and Drug Administration · Rule · Published 2003-05-15 · Effective 2003-05-15 · 68 FR 26204
Document
Document number
03-12121
Federal Register citation
68 FR 26204
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2003-05-15
Effective date
2003-05-15
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 change to over-the-counter marketing status for the oral use of fenbendazole suspension in goats for removal and control of stomach worms.