# Ophthalmic and Topical Dosage Form New Animal Drugs; Miconazole, Polymixin B, and Prednisolone Suspension
> **Food and Drug Administration** · Final rule. · Published 2010-01-29 · Effective 2010-01-29 · 75 FR 4692
## Document
- **Document number:** 2010-1794
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 75 FR 4692
- **CFR reference:** 21 CFR 524
- **Publication date:** 2010-01-29
- **Effective date:** 2010-01-29
- **HHS docket:** Docket No. FDA-2010-N-0002
## Abstract

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Janssen Pharmaceutica NV. The NADA provides for use of miconazole nitrate, polymixin B sulfate, and prednisolone acetate for the treatment of otitis externa in dogs.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2010/01/29/2010-1794/ophthalmic-and-topical-dosage-form-new-animal-drugs-miconazole-polymixin-b-and-prednisolone)
---
*AI Analytics · CC0 1.0*