FDA.reportPublic FDA data

Application 214366

Type
ANDA
Sponsor
MSN LABS PVT 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
69539-090Erlotinib HydrochlorideErlotinib HydrochlorideMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-091Erlotinib HydrochlorideErlotinib HydrochlorideMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-092Erlotinib HydrochlorideErlotinib HydrochlorideMSN LABORATORIES PRIVATE LIMITEDANDACurrent
72205-080Erlotinib HydrochlorideErlotinib HydrochlorideNovadoz Pharmaceuticals LLCANDACurrent
72205-081Erlotinib HydrochlorideErlotinib HydrochlorideNovadoz Pharmaceuticals LLCANDACurrent
72205-082Erlotinib HydrochlorideErlotinib HydrochlorideNovadoz Pharmaceuticals LLCANDACurrent