FDA.reportPublic FDA data

Application 215037

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NELARABINENELARABINEINJECTABLE;INTRAVENOUS250MG/50ML (5MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70710-1726NelarabineNelarabineZydus Pharmaceuticals USA Inc.ANDACurrent
70710-1726NelarabineNelarabineZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1839NelarabineNelarabineZydus Pharmaceuticals USA Inc.ANDACurrent
70710-1839NelarabineNelarabineZydus Pharmaceuticals USA Inc.ANDACurrent
70771-1685NelarabineNelarabineCadila Healthcare LimitedANDACurrent
70771-1685NelarabineNelarabineZydus Lifesciences LimitedANDACurrent