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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: nitazoxanide
Date Designated: 10/23/2001
Orphan Designation: Treatment for intestinal amebiasis
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Romark Laboratories, L.C.
6200 Courtney Campbell Causeway
Suite 880
Tampa, Florida 33607
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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