Drug Approval Package
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Epivir-HBV
(Lamivudine) Oral Solution
Company: GlaxoSmithKline
Application No.: 21-003S2 & 21004S2
Approval Date: 8/16/01
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Approval Letter(s) (PDF)
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Printed Labeling (PDF)
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Medical Review(s) (PDF)
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Statistical Review(s) (PDF)
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Microbiology Review(s) (PDF)
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Correspondence (PDF)
Date created: November 26, 2001
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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