sorafenib
SORAFENIB TABLETS. These highlights do not include all the information needed to use SORAFENIB TABLETS safely and effectively. See full prescribing information for SORAFENIB TABLETS. Sorafenib tablets, for oral use Initial U.S. Approval: 2005
Approved
Approval ID
faa9d847-2cd5-6538-e053-6394a90aa92b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 19, 2023
Manufacturers
FDA
Golden State Medical Supply, Inc.
DUNS: 603184490
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
sorafenib
PRODUCT DETAILS
NDC Product Code51407-760
Application NumberANDA209050
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 19, 2023
Generic Namesorafenib
INGREDIENTS (9)
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SORAFENIBActive
Quantity: 200 mg in 1 1
Code: 9ZOQ3TZI87
Classification: ACTIB
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT