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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
Bellerophon Therapeutics
184 Liberty Corner Road
Suite 302
Warren, New Jersey 07059
United States

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.