Drug Approval Package

 Pepcid Complete Chewable Tablets
Company:  Merck Research Laboratories
Application No.:  20958
Approval Date: 10/16/2000

• Approval Letter(s) (PDF)  

• Printed Labeling (PDF)  

• Medical Review(s) 
  Part 1 (PDF)  
  Part 2 (PDF)  
  Part 3 (PDF)  
  Part 4 (PDF)  

• Chemistry Review(s) (PDF)  

• Pharmacology Review(s) (PDF)  

• Statistical Review(s) 
  Part 1 (PDF)  
  Part 2 (PDF)  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  

• Administrative Document(s)
  Part 1 (PDF)  
  Part 2 (PDF)  

• Correspondence (PDF)  

Date created: September 25, 2003

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