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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: 1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt
Date Designated: 09/28/2017
Orphan Designation: Treatment of Acute Myeloid Leukemia
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 10/31/2022
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Cardiff Oncology, Inc.
11055 Flintkote Avenue
San Diego, California 92121
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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