Drug Approval Package
Atacand (Candesartan Cilexetil) Tablets
Company: Astra Merck Inc.
Application No.: 20-838
Approval Date: 6/4/1998
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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)
Part 5 (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)
Date created: April 11, 2002
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