Oral Dosage Form New Animal Drugs; Ivermectin Tables and Chewable Cubes
other · Food and Drug Administration · Rule · Published 1996-07-31 · Effective 1996-07-31 · 61 FR 39867
Document
Document number
96-19410
Federal Register citation
61 FR 39867
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1996-07-31
Effective date
1996-07-31
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of two supplemental new animal drug applications (NADA's) filed by Merck Research Laboratories, Division of Merck & Co., Inc. The supplemental NADA's provide for label changes including a revised indication and limitation for oral use of ivermectin tablets and chewable cubes for dogs to prevent canine heartworm disease.