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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: drug component, inhaled nitric oxide, of the inhaled nitric oxice/INOpulse® Device combination product
Date Designated: 09/10/2019
Orphan Designation: Treatment of idiopathic pulmonary fibrosis
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Mallinckrodt Pharmaceuticals Ireland Limited
College Business and Technology Park
Cruiserath Road, Blanchardstown
Dublin 15
Ireland

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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