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)
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