Erlotinib
HIGHLIGHTS OF PRESCRIBING INFORMATION 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 use Initial U.S. Approval: 2004
Approved
Approval ID
a436687b-3fe7-386e-e053-2995a90a47da
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 14, 2021
Manufacturers
FDA
Areva Pharmaceuticals
DUNS: 833189835
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Erlotinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59923-725
Application NumberANDA211960
Product Classification
M
Marketing Category
C73584
G
Generic Name
Erlotinib
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 14, 2021
FDA Product Classification
INGREDIENTS (10)
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
ERLOTINIB HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: DA87705X9K
Classification: ACTIM
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
Erlotinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59923-727
Application NumberANDA211960
Product Classification
M
Marketing Category
C73584
G
Generic Name
Erlotinib
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 14, 2021
FDA Product Classification
INGREDIENTS (10)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ERLOTINIB HYDROCHLORIDEActive
Quantity: 150 mg in 1 1
Code: DA87705X9K
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
Erlotinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59923-726
Application NumberANDA211960
Product Classification
M
Marketing Category
C73584
G
Generic Name
Erlotinib
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 14, 2021
FDA Product Classification
INGREDIENTS (10)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ERLOTINIB HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: DA87705X9K
Classification: ACTIM
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT