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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Primaquine phosphate
Date Designated: 07/23/1993
Orphan Designation: For use in combination with clindamycin hydrochloride in the treatment of Pneumocystis carinii pneumonia associated with AIDS.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Sanofi Winthrop, Inc.
90 Park Avenue
New York, New York 10016
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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