Drug Approval Package

Epivir-HBV (Lamivudine) Oral Solution
Company:  GlaxoSmithKline
Application No.:  21-003S2 & 21004S2
Approval Date: 8/16/01

• Approval Letter(s) (PDF)  

• Printed Labeling (PDF)  

• Medical Review(s) (PDF)  

• Statistical Review(s) (PDF)

• Microbiology Review(s) (PDF)

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  

• Administrative Document(s) (PDF)

• Correspondence (PDF)

Date created: November 26, 2001

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