Gefitinib
These highlights do not include all the information needed to use GEFITINIB TABLETS safely and effectively. See full prescribing information for GEFITINIB TABLETSGEFITINIB tablets, for oral useInitial U.S. Approval: 2015
Approved
Approval ID
0afc12dd-12f8-4def-9027-f38412a862b9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 22, 2023
Manufacturers
FDA
Qilu Pharmaceutical Co., Ltd.
DUNS: 653878256
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Gefitinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67184-0531
Application NumberANDA211591
Product Classification
M
Marketing Category
C73584
G
Generic Name
Gefitinib
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 22, 2023
FDA Product Classification
INGREDIENTS (14)
GEFITINIBActive
Quantity: 250 mg in 1 1
Code: S65743JHBS
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT