# Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin Sulfate, Betamethasone Valerate, Clotrimazole Ointment; Technical Amendment
> **Food and Drug Administration** · Final rule; technical amendment. · Published 2005-02-18 · Effective 2005-02-18 · 70 FR 8290
## Document
- **Document number:** 05-3179
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 70 FR 8290
- **CFR reference:** 21 CFR 524
- **Publication date:** 2005-02-18
- **Effective date:** 2005-02-18
## Abstract

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Phoenix Scientific, Inc. The supplemental ANADA provides for a new container size, a 20-gram dropper bottle, from which gentamicin sulfate, betamethasone valerate, clotrimazole ointment may be administered for the treatment of acute and chronic canine otitis externa. The regulations are also being amended to correct the indications for use to agree with approved product labeling. This action is being taken to improve the accuracy of the regulations.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2005/02/18/05-3179/ophthalmic-and-topical-dosage-form-new-animal-drugs-gentamicin-sulfate-betamethasone-valerate)
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