Drug Approval Package

 Paroxetine Mesylate Tablets
Company:  Synthon Pharmaceuticals
Application No.:  021299
Approval Date: 3/11/2002

• Approval Letter(s) (PDF)    

• Printed Labeling (PDF)    

• Medical Review(s) (PDF)

• Chemistry Review(s) (PDF)    

• Pharmacology Review(s) (PDF)    

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)    

• Administrative Document(s)
  Part 1 (PDF)  
  Part 2 (PDF)  

• Correspondence (PDF)  

Date created: May 062004

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