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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: progesterone
Date Designated: 09/03/2009
Orphan Designation: For early intervention in the treatment of moderate to severe closed-head traumatic brain injury
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 06/10/2014
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
BHR Pharma, LLC
607 Herndon Parkway
Suite 110
Herndon, Virginia 20170
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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