Drug Approval Package

 Depakote ER (Divalproex Sodium) Extended-Release Tablets
Company:  Abbott Laboratories
Application No.:  021168
Approval Date: 8/4/2000

• Approval Letter(s) (PDF)

• Printed Labeling (PDF)

• Medical Review(s) (PDF)  

• Chemistry Review(s) (PDF)

• Pharmacology Review(s) (PDF)  

• Statistical Review(s) (PDF)

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)

• Administrative Document(s) (PDF)

• Correspondence (PDF)  

Date created: August 252004

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