Drug Approval Package

 Cymbalta (Duloxetine Hydrochloride) Capsules
Company:  Eli Lilly & Co., Inc.
Application No.:  021427
Approval Date: 8/03/2004

• Approval Letter(s) (PDF)

• Printed Labeling (PDF)

• Medical Review(s)
  Part 1 (PDF)  
  Part 2 (PDF)  
  Part 3 (PDF)  

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

• Environmental Assessment (PDF)  

• Pharmacology Review(s)
  Part 1 (PDF)  
  Part 2 (PDF)  
  Part 3 (PDF)

• Statistical Review(s) (PDF)

• Clinical Pharmacology Biopharmaceutics Review(s)
  Part 1 (PDF)  
  Part 2 (PDF)   
  Part 3 (PDF)  

• Administrative Document(s) & Correspondence (PDF)  

Date created: September 292004

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