Drug Approval Package
Mycamine (micafungin sodium) Injection
Company: Fujisawa, Inc.
Application Number: 021754
Approval Date: 3/16/2005
-
Approval Letter(s) (PDF)
-
Printed Labeling (PDF)
-
Medical Review(s) (PDF)
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF)
Part 4 (PDF)
Part 5 (PDF)
Part 6 (PDF)
Part 7 (PDF)
Part 8 (PDF)
Part 9 (PDF) -
Chemistry Review(s) (PDF)
- Microbiology Review
- Clinical Pharmacology Review
- Pharmacology Review
-
Statistical Review(s) (PDF)
Date created: December 6, 2007
Updated: February 29, 2012
Note: Documents in PDF format require the Adobe Acrobat Reader®.