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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Dapsone
Date Designated: 11/07/1994
Orphan Designation: Prophylaxis of toxoplasmosis in severely immunocompromised patients with CD4 counts below 100.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Jacobus Pharmaceutical Company, Inc.
37 Cleveland Lane
P.O. Box 5290
Princeton, New Jersey 08540
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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