Drug Approval Package
Nexium
(Esomeprazole Magnesium) Delayed-Release Capsules
Company: AstraZeneca LP
Application No.: 21-153 & 21-154
Approval Date: 2/20/2001
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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 6 (PDF) Part 2 (PDF) Part 7 (PDF) Part 3 (PDF) Part 8 (PDF) Part 4 (PDF) Part 9 (PDF) Part 5 (PDF) -
Chemistry Review(s) (PDF)
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Pharmacology Review(s) (PDF)
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Statistical Review(s) (PDF)
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Microbiology Review(s) (PDF)
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Clinical Pharmacology Biopharmaceutics Review(s)
Part 1 (PDF)
Part 2 (PDF)
Date created: September 07, 2001
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