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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
Date Designated: 04/18/1989
Orphan Designation: Treatment and management of patients with non-Hodgkins lymphoma.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
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.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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