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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  nicardipine
Date Designated:  11/26/2019
Orphan Designation:  Treatment of Pitt-Hopkins Syndrome
Orphan Designation Status:  Designated
FDA Orphan Approval Status:  Not FDA Approved for Orphan Indication
Collaborations Pharmaceuticals, Inc.
5616 Hilltop Needmore Rd,
Fuquay Varina, North Carolina 27526
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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