sorafenib
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
68aa4b7f-3f13-4e73-b572-aa6c11a8429c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 23, 2023
Manufacturers
FDA
TWi Pharmaceuticals USA, Inc.
DUNS: 658402052
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 Code24979-715
Application NumberANDA209050
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 23, 2023
Generic Namesorafenib
INGREDIENTS (9)
SORAFENIBActive
Quantity: 200 mg in 1 1
Code: 9ZOQ3TZI87
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT