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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-(5-(2-chlorophenyl)-3-methyl-2,10-dihydropyrazolo[4,3-b] pyrido[4,3-e][1,4]diazepin-8-yl) morpholine
Date Designated: 11/06/2019
Orphan Designation: treatment of cholangiocarcinoma
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
TransThera Sciences (Nanjing), Inc.
F3, Bld 9, Accelerator Phase 2
Biotech and Pharmaceutical Valley, Jiangbei New Area
Nanjing 210032

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.