Drug Approval Package
Tracleer
(Bosentan) Tablets
Company: Actelion, Ltd
Application No.: 21-290
Approval Date: 11/20/2001
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Approval Letter(s) (PDF)
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Printed Labeling (PDF)
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Chemistry Review(s) (PDF)
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Pharmacology Review(s)
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF)
Part 4 (PDF)
Part 5 (PDF) -
Statistical Review(s) (PDF)
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Clinical Pharmacology Biopharmaceutics Review(s)
Part 1 (PDF)
Part 2 (PDF) -
Correspondence (PDF)
Date created: November 20, 2001
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