Drug Approval Package

Nolvadex (Tamoxifen Citrate) Tablets
Company:  AstraZeneca Pharmaceuticals, LP
Application No.:  21-109
Approval Date: 8/30/02

• Approval Letter(s) (PDF)  

• Printed Labeling (PDF)  

• Medical Review(s) 
  Part 1 (PDF)  
  Part 2 (PDF)  

• Chemistry Review(s) (PDF)  

• Pharmacology Review(s) (PDF)  

• Statistical Review(s) (PDF)  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  

• Administrative Document(s) (PDF)  

• Correspondence (PDF)

Date created: Febuary 20, 2003

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