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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Balsalazide disodium
Trade Name: Colazal
Date Designated: 08/12/2005
Orphan Designation: Treatment of pediatric patients with ulcerative colitis
Orphan Designation Status: Designated/Approved
Salix Pharmaceuticals, Inc.
400 Somerset Corporate Blvd
Bridgewater, New Jersey 08807
United States

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

Marketing approved:

1 Generic Name: Balsalazide disodium
Trade Name: Colazal
Marketing Approval Date: 12/20/2006
Approved Labeled Indication: Treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. Safety and Effectiveness of Colazal beyond 8 weeks in children (ages 5-17) and 12 weeks in adults have not been established.
Exclusivity End Date: 12/20/2013 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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