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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)
Trade Name: Thrombate III
Date Designated: 11/26/1984
Orphan Designation: For replacement therapy in congenital deficiency of AT-III for prevention and treatment of thrombosis and pulmonary emboli.
Orphan Designation Status: Designated/Approved
Bayer Corporation
Pharmaceutical Division, Biological Products
400 Morgan Lane
New Haven, Connecticut 06516
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: Antithrombin III (human)
Trade Name: Thrombate III
Marketing Approval Date: 12/30/1991
Approved Labeled Indication:
Exclusivity End Date: 12/30/1998 
Exclusivity Protected Indication* :  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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