Oral Dosage Form New Animal Drugs; Ivermectin and Pyrantel Pamoate Chewable Tablets
other · Food and Drug Administration · Rule · Published 2001-07-09 · Effective 2001-07-09 · 66 FR 35755
Document
Document number
01-17051
Federal Register citation
66 FR 35755
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2001-07-09
Effective date
2001-07-09
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Blue Ridge Pharmaceuticals, Inc. The ANADA provides for use of chewable tablets containing ivermectin and pyrantel pamoate for prevention of heartworm disease and for treatment and control of certain gastrointestinal parasites in dogs.