Drug Approval Package
Colazal (Balsalazide Disodium) Capsules
Company: Salix Pharmaceuticals, Inc.
Application No.: 20-10
Approval Date: 7/18/2000
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Approval Letter(s) (PDF)
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Printed Labeling (PDF)
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Medical Review(s)
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF)
Part 4 (PDF) -
Chemistry Review(s) (PDF)
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Pharmacology Review(s)
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF) -
Statistical Review(s) (PDF)
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Clinical Pharmacology Biopharmaceutics Review(s)
Part 1 (PDF)
Part 2 (PDF) -
Administrative Document(s) & Correspondence
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF)
Date created: July 31, 2002
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