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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
Trade Name: Alinia
Date Designated: 02/14/2002
Orphan Designation: Treatment of intestinal giardiasis
Orphan Designation Status: Designated/Approved
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.

Marketing approved:

1 Generic Name: nitazoxanide
Trade Name: Alinia
Marketing Approval Date: 11/22/2002
Approved Labeled Indication: Treatment of diarrhea caused by Cryptosporidium parvum and Giardia lamblia
Exclusivity End Date: 11/22/2009 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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