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
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Approval Letter (PDF) (348 KB)
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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)
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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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