Drug Approval Package
Lusedra (Fospropofol Disodium) Injection
Company: Eisai Medical Research Inc.
Application No.: 022244
Approval Date: 12/12/2008
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Summary Review (PDF)
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Officer/Employee List (PDF)
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Office Director Memo (PDF)
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Printed Labeling (PDF)
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Medical Review(s)
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Chemistry Review(s) (PDF)
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Pharmacology Review(s)
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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)
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Other Review(s) (PDF)
Approval Letter(s) (PDF)
Date created: February 13, 2009
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