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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Nitric Oxide
Date Designated: 11/08/2022
Orphan Designation: To selectively reduce pulmonary arterial pressures in patients at elevated risk for developing hemodynamically unstable pulmonary hypertension after cardiovascular surgery
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Mallinckrodt Pharmaceuticals
90 Washington Valley Road
Bedminster, New Jersey 07921
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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