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
63473087-5cc1-b2e8-b552-6d5f733e1227
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 5, 2023
Manufacturers
FDA
Alvogen Inc.
DUNS: 008057330
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 Code47781-466
Application NumberANDA206398
Product Classification
M
Marketing Category
C73584
G
Generic Name
VORICONAZOLE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 5, 2021
FDA Product Classification
INGREDIENTS (2)
BETADEX SULFOBUTYL ETHER SODIUMInactive
Code: 2PP9364507
Classification: IACT
VORICONAZOLEActive
Quantity: 10 mg in 1 mL
Code: JFU09I87TR
Classification: ACTIB