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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: quinine Sulfate
Trade Name:
Date Designated: 06/03/2004
Orphan Designation: Treatment of malaria
Orphan Designation Status: Designated/Approved
AR Holding Company, Inc.
1100 Orthodox Street
Philadelphia, Pennsylvania 19124
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: quinine Sulfate
Trade Name:
Marketing Approval Date: 08/12/2005
Approved Labeled Indication: Treatment of uncomplicated Plasmodium falciparum malaria
Exclusivity End Date: 08/12/2012 
Exclusivity Protected Indication* :  

*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.