Ophthalmic and Topical Dosage Form New Animal Drugs; Milbemycin Oxime Solution
other · Food and Drug Administration · Rule · Published 2000-03-15 · Effective 2000-03-15 · 65 FR 13904
Document
Document number
00-6284
Federal Register citation
65 FR 13904
CFR reference
21 CFR 524
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2000-03-15
Effective date
2000-03-15
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 veterinary prescription use of milbemycin oxime solution to treat ear mite infestations in cats and kittens 8 weeks of age and older.