Oral Dosage Form New Animal Drugs; Fenbendazole Paste
other · Food and Drug Administration · Rule · Published 1998-06-10 · 63 FR 31624
Document
Document number
98-15480
Federal Register citation
63 FR 31624
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1998-06-10
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 Hoechst Roussel Vet. The supplemental NADA provides for expanding the indications to include treatment of encysted mucosal cyathostome (small strongyle) larvae including early third stage (hypobiotic), late third stage, and fourth stage larvae.