Gefitinib
These highlights do not include all the information needed to use GEFITINIB TABLETS safely and effectively. See full prescribing information for GEFITINIB TABLETS. GEFITINIB TABLETS for oral use Initial U.S. Approval: 2015
Approved
Approval ID
1a3c0ce7-06a1-4e04-9106-14ddb2a866a5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 27, 2023
Manufacturers
FDA
Natco Pharma USA LLC
DUNS: 079590418
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 Code69339-168
Application NumberANDA212827
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 27, 2023
Generic NameGefitinib
INGREDIENTS (14)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
GEFITINIBActive
Quantity: 250 mg in 1 1
Code: S65743JHBS
Classification: ACTIB
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMK
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT