FDA.reportPublic FDA data

Application 091059

Type
ANDA
Sponsor
TEVA PHARMS USA

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
0093-7662ErlotinibErlotinibTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7663ErlotinibErlotinibTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7663ErlotinibErlotinibTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7663ErlotinibErlotinibTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7663ErlotinibErlotinibTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7664ErlotinibErlotinibTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7664ErlotinibErlotinibTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7664ErlotinibErlotinibTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7664ErlotinibErlotinibTeva Pharmaceuticals USA, Inc.ANDACurrent