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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
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
Knoa Pharma LLC
One Stamford Forum, 201 Tresser Boulevard
Stamford, Connecticut 06901
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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