Drug Approval Package

Paxil CR (Paroxetine Hydrochloride)
Company:  Smith Kline Beecham
Application No.:  020936
Approval Date: 2/16/1999

• Approval Letter(s) (PDF)  

• Printed Labeling (PDF)  

• Medical Review(s) 

  Part 1 (PDF)
  Part 2 (PDF)

• Chemistry Review(s) (PDF)  

• Pharmacology Review(s)

• Statistical Review(s) (PDF)  

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

• Administrative Document(s) & Correspondence (PDF)

Date created: August 09, 2001

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