Drug Approval Package

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Drug Approval Package

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Ambisome (Amphotericin B)
Company: Astellas
Application No.: 050740
Approval Date: 8/11/1997

Approval Letter(s) and Medical Review Part 1) (PDF)
Medical Review Part 2 (PDF)
Medical Review Part 3 (PDF)
Medical Review Part 4 (PDF)
Pharmacology Review(s) (PDF)
Statistical Review(s) (PDF)
Microbiology Review(s) (PDF)
Administrative and Correspondence Document(s) (PDF)

Date created: October 29, 1998

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