Oral Dosage Form New Animal Drugs; Pyrantel Pamoate Chewable Tablets
other · Food and Drug Administration · Rule · Published 2001-02-09 · Effective 2001-02-09 · 66 FR 9650
Document
Document number
01-3415
Federal Register citation
66 FR 9650
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2001-02-09
Effective date
2001-02-09
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 pyrantel pamoate chewable tablets for the removal of certain gastrointestinal parasites and prevention of reinfection in puppies and dogs.