Oral Dosage Form New Animal Drugs; Nitenpyram Tablets
other · Food and Drug Administration · Rule · Published 2000-11-27 · Effective 2000-11-27 · 65 FR 70661
Document
Document number
00-30047
Federal Register citation
65 FR 70661
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2000-11-27
Effective date
2000-11-27
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Novartis Animal Health US, Inc. The NADA provides for the oral use of nitenpyram tablets for the treatment of flea infestations in dogs, puppies, cats, and kittens that are 4 weeks of age and older and 2 pounds (lb) of body weight or greater.