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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: cyclophosphamide
Date Designated: 06/17/2011
Orphan Designation: Prevention of graft versus host disease following allogeneic hematopoietic stem cell transplant
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Accentia Biopharmaceuticals, Inc.
324 S. Hyde Park Avenue
Tampa, Florida 33606
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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