Drug Approval Package
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Xeloda
(Capecitabine) Tablets
Company: Roche Pharmaceuticals
Application No.: 20-896/S006 & S009
Approval Date: 4/30/01
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Approval(ble) Letter(s) (PDF)
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Medical Review(s)/Statistical Review
Part 1 (PDF)
Part 2 (PDF) -
Chemistry Review(s) (PDF)
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Pharmacology Review(s) (PDF)
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Statistical Review(s) (PDF)
Date created: November 20, 2001
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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