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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: 09/05/2008
Orphan Designation: Use in combination with a drug delivery device for acute treatment of sickle cell vaso-occlusive crisis (pain crises)
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Mallinckrodt Hospital Products IP Unlimited
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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