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Ophthalmic and Topical Dosage Form New Animal Drugs; Hydrocortisone Aceponate, Miconazole Nitrate, and Gentamicin Sulfate Otic Suspension

Health and Human Services Department, Food and Drug Administration

Closed
NAICS 325412
Source: Federal Register
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Key Details

Posted Date
Response Deadline
NAICS Code
325412
Source
Federal Register
Contract Type
regulation

Description

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.

Key Dates

Posted:Deadline:

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Data sourced from Federal Register

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Ophthalmic and Topical Dosage Form New Animal Drugs; Hydroco — Health and Human Services Department, Food and Drug Administration | Bureauify