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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Tacrolimus
Trade Name: Prograf
Date Designated: 06/06/2005
Orphan Designation: Prophylaxis of organ rejection in patients receiving heart transplants.
Orphan Designation Status: Designated/Approved
Astellas Pharma US, Inc.
Three Parkway North
Deerfield, Illinois 60015
United States

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

Marketing approved:

1 Generic Name: Tacrolimus
Trade Name: Prograf
Marketing Approval Date: 03/29/2006
Approved Labeled Indication: Prophylaxis of organ rejection in patients receiving allogenic heart transplants.
Exclusivity End Date: 03/29/2013 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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