Nexavar
These highlights do not include all the information needed to use NEXAVAR safely and effectively. See full prescribing information for NEXAVAR. Initial U.S. Approval: 2005
Approved
Approval ID
b50667e4-5ebc-4968-a646-d605058dbef0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 28, 2023
Manufacturers
FDA
Bayer HealthCare Pharmaceuticals Inc.
DUNS: 005436809
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
sorafenib
PRODUCT DETAILS
NDC Product Code50419-488
Application NumberNDA021923
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateAugust 28, 2023
Generic Namesorafenib
INGREDIENTS (9)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SORAFENIBActive
Quantity: 200 mg in 1 1
Code: 9ZOQ3TZI87
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
sorafenib
PRODUCT DETAILS
NDC Product Code50419-489
Application NumberNDA021923
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateAugust 28, 2023
Generic Namesorafenib
INGREDIENTS (9)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SORAFENIBActive
Quantity: 200 mg in 1 1
Code: 9ZOQ3TZI87
Classification: ACTIB
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT