Drug Approval Package: MICAFUNGIN IN SODIUM CHLORIDE 0.9%

Company: Baxter Healthcare Corporation
Application Number: 216142
Approval Date: 9/29/2023

Drugs@FDA information available about MICAFUNGIN IN SODIUM CHLORIDE 0.9%

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FDA Approval Letter and Labeling

• Approval Letter(s) (PDF)
• Printed Labeling (PDF)

FDA Application Review Files

• Product Quality Review(s) (PDF)
• Non-Clinical Review(s) (PDF)
• Officer/Employee List (PDF)
• Other Review(s) (PDF)
• Summary Review (PDF)

Date created: February 08, 2024

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