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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Antithrombin III (human) concentrate IV
Date Designated: 07/02/1985
Orphan Designation: For prophylaxis and treatment of thromboembolic episodes in patients with genetic AT-III deficiency.
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
CSL Behring
1020 First Ave.
PO Box 61501
King of Prussia, Pennsylvania 19406
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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