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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  Itraconazole suspension
Date Designated:  10/30/2008
Orphan Designation:  Topical treatment of fungal otitis externa (otomycosis)
Orphan Designation Status:  Designated
FDA Orphan Approval Status:  Not FDA Approved for Orphan Indication
Fairfield Clinical Trials, LLC
200 Steep Hill Road
Weston, Connecticut 06883
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.