# Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin Sulfate, Betamethasone Valerate, and Clotrimazole Ointment
> **Food and Drug Administration** · Final rule. · Published 1998-06-11 · 63 FR 31931
## Document
- **Document number:** 98-15554
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 63 FR 31931
- **CFR reference:** 21 CFR 510
- **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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/1998/06/11/98-15554/ophthalmic-and-topical-dosage-form-new-animal-drugs-gentamicin-sulfate-betamethasone-valerate-and)
---
*AI Analytics · CC0 1.0*