Gefitinib
These highlights do not include all the information needed to use GEFITINIB TABLETS safely and effectively. See full prescribing information for GEFITINIB TABLETS. tablets, for oral use Initial U.S. Approval: 2015
Approved
Approval ID
257a3e9c-019e-ef38-de25-1ebd7585c3ea
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 20, 2023
Manufacturers
FDA
Apotex Corp.
DUNS: 845263701
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Gefitinib
PRODUCT DETAILS
NDC Product Code60505-4512
Application NumberANDA209532
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 20, 2023
Generic NameGefitinib
INGREDIENTS (10)
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMERInactive
Code: 905HNO1SIH
Classification: IACT
GEFITINIBActive
Quantity: 250 mg in 1 1
Code: S65743JHBS
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT