FDA.reportPublic FDA data

Application 091002

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ERLOTINIB HYDROCHLORIDEERLOTINIB HYDROCHLORIDETABLET;ORALEQ 25MG BASENoNo
002ERLOTINIB HYDROCHLORIDEERLOTINIB HYDROCHLORIDETABLET;ORALEQ 100MG BASENoNo
003ERLOTINIB HYDROCHLORIDEERLOTINIB HYDROCHLORIDETABLET;ORALEQ 150MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-7131Erlotinib Hydrochlorideerlotinib hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-7131Erlotinib Hydrochlorideerlotinib hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-7132Erlotinib Hydrochlorideerlotinib hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-7132Erlotinib Hydrochlorideerlotinib hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-7133Erlotinib Hydrochlorideerlotinib hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-7133Erlotinib Hydrochlorideerlotinib hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
42292-051Erlotinib Hydrochlorideerlotinib hydrochlorideMylan Institutional Inc.ANDACurrent
42292-051Erlotinib Hydrochlorideerlotinib hydrochlorideMylan Institutional Inc.ANDACurrent
42292-052Erlotinib Hydrochlorideerlotinib hydrochlorideMylan Institutional Inc.ANDACurrent
42292-052Erlotinib Hydrochlorideerlotinib hydrochlorideMylan Institutional Inc.ANDACurrent
42292-053Erlotinib Hydrochlorideerlotinib hydrochlorideMylan Institutional Inc.ANDACurrent
42292-053Erlotinib Hydrochlorideerlotinib hydrochlorideMylan Institutional Inc.ANDACurrent