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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: N-(2-(4-Fluorophenyl)-5,7-dimethyl-1,2,3,4-tetrahydro isoquinolin-6-yl)-2-(1-methylcyclopropyl) acetamide
Date Designated: 10/18/2023
Orphan Designation: Treatment of Amyotrophic Lateral Sclerosis
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Shanghai Zhimeng Biopharma, Inc.
1976 Gaoke Middle Rd, Suite A-302
Pudong , Shanghai 201210
China

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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