Ophthalmic and Topical Dosage Form New Animal Drugs; Miconazole, Polymixin B, and Prednisolone Suspension
other · Food and Drug Administration · Rule · Published 2010-01-29 · Effective 2010-01-29 · 75 FR 4692
Document
Document number
2010-1794
Federal Register citation
75 FR 4692
CFR reference
21 CFR 524
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2010-01-29
Effective date
2010-01-29
HHS docket
Docket No. FDA-2010-N-0002
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 Janssen Pharmaceutica NV. The NADA provides for use of miconazole nitrate, polymixin B sulfate, and prednisolone acetate for the treatment of otitis externa in dogs.