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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Rho (D) immune globulin intravenous (human)
Trade Name: WinRho SD
Date Designated: 11/09/1993
Orphan Designation: Treatment of immune thrombocytopenic purpura.
Orphan Designation Status: Designated/Approved
Rh Pharmaceuticals, Inc.
104 Chancellor Matheson Road
U of Manitoba
Winnipeg
Canada

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

Marketing approved:

1 Generic Name: Rho (D) immune globulin intravenous (human)
Trade Name: WinRho SD
Marketing Approval Date: 03/24/1995
Approved Labeled Indication: Treatment of adults and children with chronic and acute immune thrombocytopenic purpura.
Exclusivity End Date: 03/24/2002 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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