Voriconazole
These highlights do not include all the information needed to use VORICONAZOLE FOR INJECTION safely and effectively. See full prescribing information for VORICONAZOLE FOR INJECTION. VORICONAZOLE for injection, for intravenous use Initial U.S. Approval: 2002
Approved
Approval ID
b3b67028-f8a0-4a93-9e73-9e8940c22c4a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 17, 2023
Manufacturers
FDA
Fosun Pharma USA Inc.
DUNS: 080920998
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Voriconazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72266-131
Application NumberANDA211099
Product Classification
M
Marketing Category
C73584
G
Generic Name
Voriconazole
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 17, 2023
FDA Product Classification
INGREDIENTS (2)
SULFOBUTYLETHER .BETA.-CYCLODEXTRINInactive
Code: 2PP9364507
Classification: IACT
VORICONAZOLEActive
Quantity: 10 mg in 1 mL
Code: JFU09I87TR
Classification: ACTIB