Oral Dosage Form New Animal Drugs; Albendazole Suspension
other · Food and Drug Administration · Rule · Published 1999-01-11 · Effective 1999-01-11 · 64 FR 1503
Document
Document number
99-449
Federal Register citation
64 FR 1503
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1999-01-11
Effective date
1999-01-11
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 Pfizer, Inc. The supplemental NADA provides for anthelmintic use of the 11.36 percent albendazole suspension in sheep. Based on FDA's review of the data and information in the NADA, a tolerance for drug residues in muscle and an acceptable daily intake (ADI) are established.