Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin Sulfate, Betamethasone Valerate, Clotrimazole Ointment
other · Food and Drug Administration · Rule · Published 2003-07-21 · Effective 2003-07-21 · 68 FR 42969
Document
Document number
03-18353
Federal Register citation
68 FR 42969
CFR reference
21 CFR 524
Type
Rule
Action
Final rule; technical amendment.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2003-07-21
Effective date
2003-07-21
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Phoenix Scientific, Inc. The ANADA provides for the use of gentamicin sulfate, betamethasone valerate, and clotrimazole ointment for the treatment of canine otitis externa.