FDA.reportPublic FDA data

Application 213065

Type
ANDA
Sponsor
ZYDUS PHARMS

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
68382-913ErlotinibErlotinibZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-913ErlotinibErlotinibZydus Pharmaceuticals USA Inc.ANDACurrent
68382-914ErlotinibErlotinibZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-914ErlotinibErlotinibZydus Pharmaceuticals USA Inc.ANDACurrent
68382-915ErlotinibErlotinibZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-915ErlotinibErlotinibZydus Pharmaceuticals USA Inc.ANDACurrent
70771-1521ErlotinibErlotinibCadila Healthcare LimitedANDACurrent
70771-1522ErlotinibErlotinibCadila Healthcare LimitedANDACurrent
70771-1523ErlotinibErlotinibCadila Healthcare LimitedANDACurrent