FDA.reportPublic FDA data

Application 072735

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEUCOVORIN CALCIUMLEUCOVORIN CALCIUMTABLET;ORALEQ 15MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-4498Leucovorin CalciumLeucovorin CalciumWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-4498Leucovorin CalciumLeucovorin CalciumWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-4498Leucovorin CalciumLeucovorin CalciumWest-Ward Pharmaceuticals Corp.ANDACurrent