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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Orphan Designation Status:  Designated/Withdrawn
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 Jan. 1, 2013, to the present.
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