Drug Approval Package
Tykerb (Lapatinib) Tablets
Company: SmithKlineBeecham Corporation d/b/a GlaxoSmithKline
Application No.: 022059
Approval Date: 03/13/2007
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Approval Letter(s) (PDF)
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Printed Labeling (PDF)
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Chemistry Review(s) (PDF)
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Pharmacology Review(s)
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF) -
Statistical Review(s) (PDF)
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Administrative Document(s) & Correspondence
Part 1 (PDF)
Part 2 (PDF)
Date created: May 09, 2007
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