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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  tinostamustine hydrochloride
Trade Name:  N/A
Date Designated:  03/15/2019
Orphan Designation:  Treatment of T-cell prolymphocytic leukemia
Orphan Designation Status:  Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Marketing Approval Date:  N/A
Approved Labeled Indication:  
Exclusivity End Date:    N/A
Mundipharma EDO GmbH
St. Alban-Rheinweg 74
Basel
Switzerland

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