Search Orphan Drug Designations and Approvals
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Generic Name: | Balsalazide disodium | ||||||||||||||||
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Trade Name: | Colazal | ||||||||||||||||
Date Designated: | 08/12/2005 | ||||||||||||||||
Orphan Designation: | Treatment of pediatric patients with ulcerative colitis | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
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. |
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Marketing approved: |
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1 | Generic Name: | Balsalazide disodium |
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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* : | ||
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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