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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: sodium benzoate and clozapine
Date Designated: 12/22/2011
Orphan Designation: Treatment of treatment-resistant schizophrenia
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
SyneuRx International Corp.
20F-9 99 Section 1, Xintaiwu Road
Xizhi District
New Taipei City

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.