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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: 2-[[3-({4-[(5-{2-[(3-Fluorophenyl)amino]-2-oxoethyl}-1H-pyrazol-3-yl)amino]-quinazolin-7-yl}propyl](ethyl)amino]ethyl dihydrogen phosphate trihydrate
Date Designated: 01/19/2010
Orphan Designation: Treatment of acute myeloid leukemia
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
AstraZeneca Pharmaceuticals LP
1800 Concord Pike
P. O. Box 8355
Wilmington, Delaware 19803
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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