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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Dihydrotestosterone Gel
Date Designated: 07/09/2020
Orphan Designation: Treatment of micropenis
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Besins Healthcare Ireland Ltd.
16 Pembroke Street Upper
DO2HE63
Dublin 2
Ireland

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.
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