Oral Dosage Form New Animal Drugs; Milbemycin Oxime Tablets
other · Food and Drug Administration · Rule · Published 1998-08-03 · Effective 1998-08-03 · 63 FR 41188
Document
Document number
98-20533
Federal Register citation
63 FR 41188
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1998-08-03
Effective date
1998-08-03
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 Novartis Animal Health US, Inc. The supplemental NADA provides for use of a lower dose of milbemycin oxime in treating dogs and puppies for the prevention of heartworm disease.