FDA.reportPublic FDA data

Application 072736

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEUCOVORIN CALCIUMLEUCOVORIN CALCIUMTABLET;ORALEQ 25MG BASENoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-4499Leucovorin CalciumLeucovorin CalciumWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-4499Leucovorin CalciumLeucovorin CalciumWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-4499Leucovorin CalciumLeucovorin CalciumWest-Ward Pharmaceuticals Corp.ANDACurrent
0904-6703Leucovorin CalciumLeucovorin CalciumMajor PharmaceuticalsANDACurrent
0904-6703Leucovorin CalciumLeucovorin CalciumMajor PharmaceuticalsANDACurrent
0904-6703Leucovorin CalciumLeucovorin CalciumMajor PharmaceuticalsANDACurrent