Drug Approval Package

 Betapace AF (Sotalol Hydrochloride) Tablets
Company:  Berlex Laboratories
Application No.:  021151
Approval Date: 2/22/2000

• Approval Letter(s) (PDF)

• Approvable Letter(s) (PDF)  

• Printed Labeling (PDF)  

• Chemistry Review(s) (PDF)

• Administrative Document(s) & Correspondence (PDF)  

Date created: March 202006

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