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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: 8-bromo-2-(1-methylpiperidin-4-yl) amino)-4-(4-phenoxyphenyl) amino) pyrido[4,3-d] pyrimidin-5(6H)-one hydrochloride
Date Designated: 11/20/2018
Orphan Designation: Treatment of Acute Myeloid Leukemia
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Oscotec Inc.
Korea Bio-Park Bldg A, 9th Floor
700 Dawwangpangyo-ro, Bundang-gu
Seongnam-si, Gyeonggi-do
South Korea

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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