Erlotinib
These highlights do not include all the information needed to use ERLOTINIB TABLETS safely and effectively. See full prescribing information for ERLOTINIB TABLETS.ERLOTINIB tablets, for oral useInitial U.S. Approval: 2004
Approved
Approval ID
2c4c7353-b81c-4651-8aac-6d15e88145af
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 25, 2019
Manufacturers
FDA
Armas Pharmaceuticals Inc.
DUNS: 098405973
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Erlotinib hydrochloride
PRODUCT DETAILS
NDC Product Code72485-218
Application NumberANDA211960
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateNovember 8, 2019
Generic NameErlotinib hydrochloride
INGREDIENTS (10)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ERLOTINIB HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: DA87705X9K
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT