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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: tinidazole
Trade Name: Tindamax
Date Designated: 04/18/2002
Orphan Designation: Treatment of giardiasis
Orphan Designation Status: Designated/Approved
Presutti Laboratories, Inc.
1607 N. Douglas Ave.
Arlington Heights, Illinois 60004
United States

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

Marketing approved:

1 Generic Name: tinidazole
Trade Name: Tindamax
Marketing Approval Date: 05/17/2004
Approved Labeled Indication: Treatment of giardiasis caused by G. duodenalis (also termed G. lamblia) in both adults and pediatric patients older than three years of age
Exclusivity End Date: 05/17/2011 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.