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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50419-488
Application NumberNDA021923
Product Classification
M
Marketing Category
C73594
G
Generic Name
sorafenib
Product Specifications
Route of AdministrationORAL
Effective DateAugust 28, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50419-489
Application NumberNDA021923
Product Classification
M
Marketing Category
C73594
G
Generic Name
sorafenib
Product Specifications
Route of AdministrationORAL
Effective DateAugust 28, 2023
FDA Product Classification
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