Drug Approval Package
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Lexiva (fosamprenavir calcium; FPV) Oral Suspension
Company: GlaxoSmithKline, Inc.
Application No.: 022116
Approval Date: 6/14/2007
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- Approval Letter(s) (PDF)
- Printed Labeling (PDF)
- Medical Review(s) (PDF)
- Chemistry Review(s) (PDF)
- Microbiology Review(s) (PDF)
- Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
- Administrative Document(s) & Correspondence (PDF)
Date created: November 10, 2009
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