Drug Approval Package
Uroxatral (alfuzosin
hydrochloride) extended release tablets
Company: Sanofi-Synthelabo Inc.
Application No.: 021287
Approval Date: 6/12/2003
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Approval Letter(s) (PDF)
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Printed Labeling (PDF)
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Medical Review(s) (PDF)
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF) -
Chemistry Review(s) (PDF)
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Statistical Review(s) (PDF)
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Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
Part 1 (PDF)
Part 2 (PDF) -
Administrative Document(s) (PDF)
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF)
Part 4 (PDF)
Part 5 (PDF) -
Correspondence (PDF)
Date created: September 9, 2003
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