Drug Approval Package

 Caduet (amlodipine besylate/atorvastatin calcium) Tablets
Company:  Pfizer, Inc.
Application No.:  021540
Approval Date: 1/30/2004

• Approval Letter(s) (PDF)

• Printed Labeling (PDF)

• Medical Review(s) (PDF)

• Chemistry Review(s) (PDF)

• Environmental Assessment (PDF)  

• Pharmacology Review(s) (PDF)  

• Statistical Review(s) (PDF)

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)

• Administrative Document(s) & Correspondence (PDF)  

Date created: August 042004

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