federal_register: 2010-1794

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2010-1794 Ophthalmic and Topical Dosage Form New Animal Drugs; Miconazole, Polymixin B, and Prednisolone Suspension Rule 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. 2010-01-29 2010 1 https://www.federalregister.gov/documents/2010/01/29/2010-1794/ophthalmic-and-topical-dosage-form-new-animal-drugs-miconazole-polymixin-b-and-prednisolone https://www.govinfo.gov/content/pkg/FR-2010-01-29/pdf/2010-1794.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 a new animal drug application (NADA) filed by Janssen Pharmaceutica NV. The NADA provides for use of miconazole nitrate, polymixin B sulfate, and...

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