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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: 09/27/2004
Orphan Designation: To reduce the risk of chronic lung disease in premature neonates
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Mallinckrodt Hospital Products
1425 U.S. 206
Bedminster Township, 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 Jan. 1, 2013, to the present.
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