Search Orphan Drug Designations and Approvals
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Generic Name: | Bendamustine hydrochloride | ||||||||||||||||
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Trade Name: | Treanda | ||||||||||||||||
Date Designated: | 08/17/2007 | ||||||||||||||||
Orphan Designation: | Treatment of chronic lymphocytic leukemia | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
Cephalon, Inc. 41 Moores Road Frazer, Pennsylvania 19355 United States The sponsor address listed is the last reported by the sponsor to OOPD. |
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Marketing approved: |
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1 | Generic Name: | Bendamustine hydrochloride |
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Trade Name: | Treanda | |
Marketing Approval Date: | 03/20/2008 | |
Approved Labeled Indication: | Treatment of patients with chronic lymphocytic leukemia | |
Exclusivity End Date: | 03/20/2015 | |
Exclusivity Protected Indication* : | ||
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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