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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72485-218
Application NumberANDA211960
Product Classification
M
Marketing Category
C73584
G
Generic Name
Erlotinib hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 8, 2019
FDA Product Classification
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