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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: 5-(4-((2S,5S)-5-(4-chlorobenzyl)-2-methylmorpholino)piperidin-1-yl)-1H-1,2,4-triazol-3-amine
Date Designated: 02/25/2019
Orphan Designation: Treatment of idiopathic pulmonary fibrosis
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Molecure S.A. (previously OncoArendi S.A.)
101 Zwirki i Wigury street,
Warsaw 02-089
Poland

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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