Oral Dosage Form New Animal Drugs; Praziquantel, Pyrantel Pamoate, and Febantel Tablets
other · Food and Drug Administration · Rule · Published 2003-04-28 · Effective 2003-04-28 · 68 FR 22293
Document
Document number
03-10416
Federal Register citation
68 FR 22293
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2003-04-28
Effective date
2003-04-28
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 Bayer Corp., Agriculture Division, Animal Health. The supplemental NADA provides for use of a larger size of praziquantel/pyrantel pamoate/febantel tablet for the removal of several species of internal parasites in dogs.