Drug Approval Package

 Paxil (Paroxetine Hydrochloride) Tablets
Company:  GlaxoSmithKline
Application No.:  020031/S026
Approval Date: 4/13/2001

• Approval Letter(s) (PDF)    

• Printed Labeling (PDF)    

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

• Statistical Review(s) (PDF)    

• Administrative Document(s) & Correspondence (PDF)  

Date created: June 28, 2004

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