Gefitinib

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

0480-4053

Application Number

ANDA208913

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

June 21, 2023

Ingredients

Code: S65743JHBSClass: ACTIBQuantity: 250 mg in 1 1

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

POVIDONEInactive

Code: FZ989GH94EClass: IACT

POLYETHYLENE GLYCOL 3350Inactive

Code: G2M7P15E5PClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT