Oral Dosage Form New Animal Drugs; Ivermectin, Fenbendazole, and Praziquantel Tablets
other · Food and Drug Administration · Rule · Published 2008-06-13 · Effective 2008-06-13 · 73 FR 33692
Document
Document number
E8-13354
Federal Register citation
73 FR 33692
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2008-06-13
Effective date
2008-06-13
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Intervet, Inc. The NADA provides for the veterinary prescription use of chewable tablets containing ivermectin, fenbendazole, and praziquantel for the treatment and control of various internal parasites and for the prevention of canine heartworm disease in adult dogs.