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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: (R)-6-(2-fluorophenyl)-N-(3-(2-((2-methoxyethyl)amino)ethyl)phenyl)-5,6-dihydrobenzo[h]quinazolin-2-amine dihydrochloride
Date Designated: 11/19/2015
Orphan Designation: Treatment of cholangiocarcinoma.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Basilea Pharmaceutical International Ltd.
Grenzacherstrasse 487
P.O. Box
Basel
Switzerland

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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