# Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin Sulfate, Mometasone Furoate, Clotrimazole Otic Suspension; Technical Amendment
> **Food and Drug Administration** · Final rule; technical amendment. · Published 2005-06-23 · Effective 2005-06-23 · 70 FR 36338
## Document
- **Document number:** 05-12402
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 70 FR 36338
- **CFR reference:** 21 CFR 524
- **Publication date:** 2005-06-23
- **Effective date:** 2005-06-23
## Abstract

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Schering-Plough Animal Health Corp. The supplemental NADA provides for a new container size, a 7.5-gram dropper bottle, from which gentamicin sulfate, mometasone furoate, clotrimazole otic suspension may be administered for the treatment of otitis externa in dogs. The regulations are also being amended to correct the description of a previously approved container size. This action is being taken to improve the accuracy of the regulations.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2005/06/23/05-12402/ophthalmic-and-topical-dosage-form-new-animal-drugs-gentamicin-sulfate-mometasone-furoate)
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