Drug Approval Package

 Namenda (Memantine HCI) Tablets
Company:  Forest Laboratories Inc.
Application No.:  021487
Approval Date: 10/16/2003

• Approval Letter(s) (PDF)

• Printed Labeling (PDF)

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

• Chemistry Review(s) (PDF)

• Pharmacology Review(s)
  Part 1 (PDF)  
  Part 2 (PDF)  
  Part 3 (PDF)  
  Part 4 (PDF)  
  Part 5 (PDF)  

• Statistical Review(s) (PDF)

• Bioequivalence Review(s)
  Part 1 (PDF)  
  Part 2 (PDF)  
  Part 3 (PDF)

• Administrative Document(s)
  Part 1 (PDF)  
  Part 2 (PDF)  
  Part 3 (PDF)

• Correspondence (PDF)   

Date created: April 04, 2002

Back to Top    Drugs@FDA

Note: Documents in PDF format require the Adobe Acrobat Reader®.