Drug Approval Package

Betapace (Sotalol Hydrochloride) Tablets
Company:  Berlex
Application No.:  19-865/S10
Approval Date: 10/1/2001

• Approval Letter(s) (PDF)  

• Printed Labeling (PDF)  

• Medical Review(s) (PDF)  

• Pharmacology Review(s) (PDF)  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  

• Administrative Document(s) (PDF)

Date created: June 19, 2002

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