Drug Approval Package

Vasotec (Enalapril Maleate) Tablets
Company:  Merck and Company Inc.
Application No.:  18-998/S059
Approval Date: 2/13/2001

• Approval Letter(s) (PDF)  

• Printed Labeling (PDF)  

• Pediatric Data Review  (PDF)  

• Medical Review(s) (PDF)  

• Chemistry Review(s) (PDF)  

• Statistical Review(s) (PDF)  

• Microbiology Review(s) (PDF)   

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  

• Administrative Document(s) (PDF)  

• Correspondence (PDF)  

Date created: July 18, 2001

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