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
9a81e485-7f26-45b6-bfd7-6114afb7def9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 13, 2023
Manufacturers
FDA
UBI Pharma Inc.
DUNS: 658871159
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 Code72843-441
Application NumberANDA211264
Product Classification
M
Marketing Category
C73584
G
Generic Name
voriconazole
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 13, 2023
FDA Product Classification
INGREDIENTS (2)
BETADEX SULFOBUTYL ETHER SODIUMInactive
Code: 2PP9364507
Classification: IACT
VORICONAZOLEActive
Quantity: 10 mg in 1 mL
Code: JFU09I87TR
Classification: ACTIB