Drug Approval Package

Lamictal Tablets &Chewable Dispersible Tablets (Lamotrigine)
Company:  Glaxo Wellcome, Inc.
Application No.:  020-241/S003 & 020-764/S001
Approval Date: 12/14/1998

• Approval Letter (PDF) (348 KB)

• Final Printed Labeling
  Part 1 (PDF) (2 MB)
  Part 2 (PDF) (2.8 MB)

• Medical Review(s)

  Part 1 (PDF) (2.4 MB)	Part 4 (PDF) (2.4 MB)	Part 7 (PDF) (2.7 MB)
  Part 2 (PDF) (2.3 MB)	Part 5 (PDF) (2.6 MB)	Part 8 (PDF) (2.9 MB)
  Part 3 (PDF) (2.4 MB)	Part 6 (PDF) (2.5 MB)	Part 9 (PDF) (2.8 MB)

• Chemistry Review(s) & EA/Fonsi (PDF) (2 MB)

• Statistical Review(s)
  Part 1 (PDF) (1.4 MB)
  Part 2 (PDF) (2.5 MB)

• Clinical Pharmacology Biopharmaceutics Review(s)
  Part 1 (PDF) (1.1 MB)
  Part 2 (PDF) (2.4 MB)

• Administrative Document(s)/Correspondence
  Part 1 (PDF) (2.3 MB)
  Part 2 (PDF) (2.3 MB)
  Part 3 (PDF) (2.3 MB)

Last updated: July 1, 2005

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