Drug Approval Package

Paxil CR (Paroxetine Hydrochloride) Controlled-Release Tablests
Company:  GlaxoSmithKline
Application No.:  20-982 & 20-936/S8
Approval Date: 2/12/2002

• 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) & Correspondence (PDF)

Date created: June 25, 2002

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