VORICONAZOLE
These highlights do not include all the information needed to use VORICONAZOLE FOR ORAL SUSPENSION safely and effectively. See full prescribing information for VORICONAZOLE FOR ORAL SUSPENSION. VORICONAZOLE for Oral SuspensionInitial U.S. Approval: 2002
Approved
Approval ID
53ecce53-57b8-4af1-b4ac-7d37eb25711f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 5, 2023
Manufacturers
FDA
Novel Laboratories, Inc.
DUNS: 793518643
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
voriconazole
PRODUCT DETAILS
NDC Product Code40032-038
Application NumberANDA206799
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 8, 2023
Generic Namevoriconazole
INGREDIENTS (8)
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
VORICONAZOLEActive
Quantity: 40 mg in 1 mL
Code: JFU09I87TR
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT