Drug Approval Package
Agenerase (Amprenavir) Capsules & Oral Solution
Company: Glaxosmithkline
Application No.: 21-007 & 21-039
Approval Date: 4/15/1999
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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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Environmental Assessment (PDF)
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Pharmacology Review(s) (PDF)
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Statistical Review(s) (PDF)
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Microbiology Review(s) (PDF)
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Clinical Pharmacology Biopharmaceutics Review(s)
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF) -
Administrative Document(s) & Correspondence
Part 1 (PDF)
Part 2 (PDF)
Date created: July 24, 2002
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