Micafungin
These highlights do not include all the information needed to use MICAFUNGIN FOR INJECTION safely and effectively. See full prescribing information for MICAFUNGIN FOR INJECTION. MICAFUNGIN for Injection, for intravenous infusion only Initial U.S. Approval: 2005
Approved
Approval ID
b7217896-fb88-44de-afe4-5b1cfef3d4fc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 28, 2022
Manufacturers
FDA
Civica, Inc.
DUNS: 081373942
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Micafungin sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72572-427
Application NumberANDA211713
Product Classification
M
Marketing Category
C73584
G
Generic Name
Micafungin sodium
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 28, 2022
FDA Product Classification
INGREDIENTS (1)
MICAFUNGIN SODIUMActive
Quantity: 100 mg in 1 1
Code: IS1UP79R56
Classification: ACTIB