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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: calcium benzoate and risperidone
Date Designated: 12/20/2010
Orphan Designation: Treatment of pediatric patients with schizophrenia
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
University of California, Los Angeles
Dept. of Psychiarty
HH212, 1000 W. Carson Street
Torrance, California 90509
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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