FDA.reportPublic FDA data

Application 210917

Type
ANDA
Sponsor
INGENUS PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEUCOVORIN CALCIUMLEUCOVORIN CALCIUMINJECTABLE;INJECTIONEQ 10MG BASE/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50742-464LEUCOVORIN CALCIUMLEUCOVORIN CALCIUMIngenus Pharmaceuticals, LLCANDACurrent
50742-464LEUCOVORIN CALCIUMLEUCOVORIN CALCIUMIngenus Pharmaceuticals, LLCANDACurrent
50742-464LEUCOVORIN CALCIUMLEUCOVORIN CALCIUMIngenus Pharmaceuticals, LLCANDACurrent