Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin Sulfate, Betamethasone Valerate, and Clotrimazole Ointment
other · Food and Drug Administration · Rule · Published 1998-06-11 · 63 FR 31931
Document
Document number
98-15554
Federal Register citation
63 FR 31931
CFR reference
21 CFR 510
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1998-06-11
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 Med-Pharmex, Inc. The ANADA provides for the use of gentamicin sulfate, betamethasone valerate, and clotrimazole (Tri-Otic ointment) for the treatment of canine acute and chronic otitis externa associated with yeast and/or bacteria susceptible to gentamicin.