FDA.reportPublic FDA data

Application 214719

Type
ANDA
Sponsor
ALEMBIC PHARMS LTD

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
46708-565ERLOTINIB HYDROCHLORIDEERLOTINIB HYDROCHLORIDEAlembic Pharmaceuticals LimitedANDACurrent
46708-566ERLOTINIB HYDROCHLORIDEERLOTINIB HYDROCHLORIDEAlembic Pharmaceuticals LimitedANDACurrent
46708-567ERLOTINIB HYDROCHLORIDEERLOTINIB HYDROCHLORIDEAlembic Pharmaceuticals LimitedANDACurrent
62332-565ERLOTINIB HYDROCHLORIDEERLOTINIB HYDROCHLORIDEAlembic Pharmaceuticals Inc.ANDACurrent
62332-566ERLOTINIB HYDROCHLORIDEERLOTINIB HYDROCHLORIDEAlembic Pharmaceuticals Inc.ANDACurrent
62332-567ERLOTINIB HYDROCHLORIDEERLOTINIB HYDROCHLORIDEAlembic Pharmaceuticals Inc.ANDACurrent