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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Gallium-68 DOTANOC
Date Designated: 04/01/2020
Orphan Designation: Diagnostic for the management of neuroblastoma
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Advanced Imaging Projects, LLC
3651 FAU Blvd.
Boca Raton, Florida 33467
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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