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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Fludarabine phosphate
Trade Name: Fludara
Date Designated: 04/18/1989
Orphan Designation: Treatment of chronic lymphocytic leukemia (CLL), including refractory CLL.
Orphan Designation Status: Designated/Approved
Berlex Laboratories, Inc.
15049 San Pablo Avenue, P.O. Box 4099
Richmond, California 94804
United States

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

Marketing approved:

1 Generic Name: Fludarabine phosphate
Trade Name: Fludara
Marketing Approval Date: 04/18/1991
Approved Labeled Indication:
Exclusivity End Date: 04/18/1998 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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