Search Orphan Drug Designations and Approvals
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Generic Name: | nitazoxanide | ||||||||||||||||
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Trade Name: | Alinia | ||||||||||||||||
Date Designated: | 02/14/2002 | ||||||||||||||||
Orphan Designation: | Treatment of intestinal giardiasis | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
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. |
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Marketing approved: |
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1 | Generic Name: | nitazoxanide |
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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* : | ||
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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