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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
Date Designated: 09/22/1997
Orphan Designation: For use as physiologic testosterone replacement in androgen deficient HIV+ patients with an associated weight loss.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Watson Laboratories
Research Park
417 Wakara Way
Salt Lake City, Utah 84108
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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