Drug Approval Package
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Drug Review Package
Iressa (gefitinib) Tablets
Company: AstraZeneca
Application No.: 021399
Approval Date: 5/5/2003
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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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Statistical Review(s) (PDF)
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Microbiology Review(s) (PDF)
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Administrative Document(s) (PDF)
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF)
Date created: July 15, 2003
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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