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
ed6624a9-0b73-4a21-bf13-a8add2081d02
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 2022
Manufacturers
FDA
Amneal Pharmaceuticals LLC
DUNS: 123797875
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 Code65162-913
Application NumberANDA205034
Product Classification
M
Marketing Category
C73584
G
Generic Name
Voriconazole
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2022
FDA Product Classification
INGREDIENTS (8)
VORICONAZOLEActive
Quantity: 40 mg in 1 mL
Code: JFU09I87TR
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT