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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Sulfadiazine
Trade Name:
Date Designated: 03/14/1994
Orphan Designation: For use in combination with pyrimethamine for the treatment of Toxoplasma gondii encephalitis in patients with and without AIDS.
Orphan Designation Status: Designated/Approved
Eon Labs Manufacturing, Inc.
227-15 North Conduit Avenue
Laurelton, New York 11413
United States

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

Marketing approved:

1 Generic Name: Sulfadiazine
Trade Name:
Marketing Approval Date: 07/29/1994
Approved Labeled Indication: Toxoplasmosis, as adjunctive with pyrimethamine
Exclusivity End Date: 07/29/2001 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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