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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: testosterone undecanoate (oral)
Date Designated: 02/13/2013
Orphan Designation: Treatment of constitutional delay in growth and puberty in adolescent boys (14-17 yrs of age)
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Marius Pharmaceuticals, LLC
8601 Six Forks Road
Suite 630
Raleigh, North Carolina 27615
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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