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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: caffeine and sodium benzoate
Date Designated: 08/22/2012
Orphan Designation: Treatment of seizure prolongation in patients undergoing electroconvulsive therapy
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Luitpold Pharmaceuticals, Inc.
One Luitpold Drive
P. O. Box 9001
Shirley, New York 11967
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.