Stivarga
These highlights do not include all the information needed to use STIVARGA safely and effectively. See full prescribing information for STIVARGA.STIVARGA® (regorafenib) tablets, for oral useInitial U.S. Approval: 2012
Approved
Approval ID
824f19c9-0546-4a8a-8d8f-c4055c04f7c7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 9, 2020
Manufacturers
FDA
Bayer HealthCare Pharmaceuticals Inc.
DUNS: 005436809
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
regorafenib
PRODUCT DETAILS
NDC Product Code50419-171
Application NumberNDA203085
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateDecember 9, 2020
Generic Nameregorafenib
INGREDIENTS (13)
REGORAFENIBActive
Quantity: 40 mg in 1 1
Code: MGN125FS9D
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT