# Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin Otic Solution
> **US Department of Health and Human Services** · Final rule. · Published 1996-09-16 · Effective 1996-09-16 · 61 FR 48624
## Document
- **Document number:** 96-23668
- **Category:** other
- **Sub-agency:** US Department of Health and Human Services
- **Federal Register citation:** 61 FR 48624
- **CFR reference:** 21 CFR 524
- **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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/1996/09/16/96-23668/ophthalmic-and-topical-dosage-form-new-animal-drugs-gentamicin-otic-solution)
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