Drug Approval Package

 Rythmol SR (Propafenone Hydrochloride) Capsules
Company:  Abbott Laboratories
Application No.:  021416
Approval Date: 9/4/2003

• Approval Letter(s) (PDF)

• Printed Labeling (PDF)

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

• Chemistry Review(s) (PDF)

• Pharmacology Review(s) (PDF)  

• Statistical Review(s) (PDF)

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)

Date created  2/11/04; updated 5/5/2004

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