Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin Otic Solution
other · US Department of Health and Human Services · Rule · Published 1996-09-16 · Effective 1996-09-16 · 61 FR 48624
Document
Document number
96-23668
Federal Register citation
61 FR 48624
CFR reference
21 CFR 524
Type
Rule
Action
Final rule.
Category
other
Sub-agency
US Department of Health and Human Services
Publication date
1996-09-16
Effective date
1996-09-16
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 use of gentamicin sulfate and betamethasone valerate otic solution to treat acute and chronic canine otitus externa and canine and feline superficial infected lesions caused by bacteria sensitive to gentamicin.