LYTGOBI
These highlights do not include all the information needed to use LYTGOBI safely and effectively. See full prescribing information for LYTGOBI. LYTGOBI (futibatinib) tablets, for oral use Initial U.S. Approval: 2022
Approved
Approval ID
0b1332a1-0581-4707-9bf6-1eccfa39bef4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 2, 2023
Manufacturers
FDA
TAIHO PHARMACEUTICAL CO., LTD.
DUNS: 690548730
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
FUTIBATINIB
PRODUCT DETAILS
NDC Product Code64842-0120
Application NumberNDA214801
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateFebruary 2, 2023
Generic NameFUTIBATINIB
INGREDIENTS (12)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FUTIBATINIBActive
Quantity: 4 mg in 1 1
Code: 4B93MGE4AL
Classification: ACTIB
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT