# Ophthalmic and Topical Dosage Form New Animal Drugs; Hydrocortisone Aceponate, Miconazole Nitrate, and Gentamicin Sulfate Otic Suspension
> **Food and Drug Administration** · Final rule. · Published 2011-12-16 · Effective 2011-12-16 · 76 FR 78150
## Document
- **Document number:** 2011-32226
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 76 FR 78150
- **CFR reference:** 21 CFR 524
- **Publication date:** 2011-12-16
- **Effective date:** 2011-12-16
- **HHS docket:** Docket No. FDA-2011-N-0003
## Abstract

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Virbac AH, Inc. The NADA provides for the veterinary prescription use of a hydrocortisone aceponate, miconazole nitrate, and gentamicin sulfate suspension for the treatment of otitis externa in dogs.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2011/12/16/2011-32226/ophthalmic-and-topical-dosage-form-new-animal-drugs-hydrocortisone-aceponate-miconazole-nitrate-and)
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