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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Cladribine
Trade Name: Leustatin Injection
Date Designated: 11/15/1990
Orphan Designation: Treatment of hairy cell leukemia.
Orphan Designation Status: Designated/Approved
R. W. Johnson Pharmaceutical Research Institute
Route 202, P.O. Box 300
Raritan, New Jersey 08869
United States

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

Marketing approved:

1 Generic Name: Cladribine
Trade Name: Leustatin Injection
Marketing Approval Date: 02/26/1993
Approved Labeled Indication:
Exclusivity End Date: 02/26/2000 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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