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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Pr-320 (molecusol-carbamazepine)
Date Designated: 07/20/1990
Orphan Designation: For the emergency rescue treatment of status epilepticus, grand mal type.
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Pharmos
2 Innovation Drive
Alachua, Florida 32615
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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