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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Dehydroepiandrosterone (DHEA)
Date Designated: 08/19/2003
Orphan Designation: Replacement therapy in individuals with adrenal insufficiency
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Paladin Labs, Inc.
6111 Royalmount Avenue, Suite 102
Montreal
Canada

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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