Oral Dosage Form New Animal Drugs; Milbemycin Oxime/Lufenuron Tablets
other · Food and Drug Administration · Rule · Published 1998-08-03 · Effective 1998-08-03 · 63 FR 41189
Document
Document number
98-20597
Federal Register citation
63 FR 41189
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 milbemycin oxime/lufenuron flavored tablet formulation for dogs not less than 4 weeks of age and not less than 11 pounds of body weight for prevention of heartworm disease, for prevention and control of flea populations, for control of hookworm, and for removal and control of roundworms and whipworms.