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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: 4-cyano-N-[2-(1-cyclohexen-1-yl)-4-[1-[dimethylamino)acetyl]-4-piperidinyl]phenyl]-1H-imidazole-2-carboxamide monohydrochloride
Date Designated: 07/20/2006
Orphan Designation: Treatment of acute myeloid leukemia
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 06/04/2021
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Johnson & Johnson Pharmaceutical Research & Dev,
920 U S Highway 202
P.O. Box 300
Raritan, New Jersey 08869
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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