Drug Approval Package
Crestor (Rosuvastatin Calcium) Tablets
Company: Astra Zeneca Pharmaceuticals
Application No.: 021366
Approval Date: 8/13/2003
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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) -
Pharmacology Review(s)
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF)
Part 4 (PDF)
Part 5 (PDF)
Part 6 (PDF)
Part 7 (PDF) -
Administrative Document(s)
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF)
Part 4 (PDF) -
Correspondence (PDF)
Date created: January /29/2004
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