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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: 08/20/2003
Orphan Designation: Treatment of amebiasis
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 intestinal amebiasis and amebic liver abcess caused by E. histolytica in both adults and pediatric patients older than three years of age. It is not indicated for the treatment of asymptomatic cyst passage.
Exclusivity End Date: 05/17/2011 
Exclusivity Protected Indication* :  

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.