Drug Approval Package

Lamictal Chewable Dispersible Tablets (Lamotrigine)
Company:  Glaxo Wellcome, Inc.
Application No.:  020-764 & 020-241/S002
Approval Date: 8/24/1998

• Approval Letter & Printed Labeling (PDF) (3.6 MB)

• Medical Review(s) (PDF) 
  Part 1 (2 MB)
  Part 2 (2 MB)
  Part 3 (2.8 MB)
  Part 4 (2.8 MB)

• Chemistry Review(s) (PDF) (762 KB)

• Pharmacology Review(s) & Statistical Review(s) (PDF) (2.3 MB)

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
  Part 1 (3 MB)
  Part 2 (2.2 MB)
  Part 3 (2 MB)
  Part 4 (1 MB)

• Administrative Document(s)/Correspondence (PDF)
  Part 1 (3 MB)
  Part 2 (2.2 MB)
  Part 3 (2 MB)
  Part 4 (1 MB)

Date created: March 30, 2001; last updated: July 1, 2005

Back to Top    Drugs@FDA

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