federal_register: 2011-32226

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2011-32226 Ophthalmic and Topical Dosage Form New Animal Drugs; Hydrocortisone Aceponate, Miconazole Nitrate, and Gentamicin Sulfate Otic Suspension Rule 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. 2011-12-16 2011 12 https://www.federalregister.gov/documents/2011/12/16/2011-32226/ophthalmic-and-topical-dosage-form-new-animal-drugs-hydrocortisone-aceponate-miconazole-nitrate-and https://www.govinfo.gov/content/pkg/FR-2011-12-16/pdf/2011-32226.pdf Health and Human Services Department; Food and Drug Administration 221,199 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...

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