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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  miconazole
Date Designated:  05/22/2014
Orphan Designation:  Treatment of fungal otitis externa (otomycosis)
Orphan Designation Status:  Designated
FDA Orphan Approval Status:  Not FDA Approved for Orphan Indication
Hill Dermaceuticals, Inc.
2650 S. Mellonville Ave.
Sanford, Florida 32773
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.