FDA.reportPublic FDA data

Application 210623

Type
ANDA
Sponsor
INGENUS PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVOLEUCOVORIN CALCIUMLEVOLEUCOVORIN CALCIUMSOLUTION;INTRAVENOUSEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)NoNo
002LEVOLEUCOVORIN CALCIUMLEVOLEUCOVORIN CALCIUMSOLUTION;INTRAVENOUSEQ 250MG BASE/25ML (EQ 10MG BASE/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50742-494LEVOLEUCOVORINlevoleucovorinIngenus Pharmaceuticals, LLCANDACurrent
50742-494LEVOLEUCOVORINlevoleucovorinIngenus Pharmaceuticals, LLCANDACurrent
50742-494LEVOLEUCOVORINlevoleucovorinIngenus Pharmaceuticals, LLCANDACurrent
50742-494LEVOLEUCOVORINlevoleucovorinIngenus Pharmaceuticals, LLCANDACurrent
50742-495LEVOLEUCOVORINlevoleucovorinIngenus Pharmaceuticals, LLCANDACurrent
50742-495LEVOLEUCOVORINlevoleucovorinIngenus Pharmaceuticals, LLCANDACurrent
50742-495LEVOLEUCOVORINlevoleucovorinIngenus Pharmaceuticals, LLCANDACurrent
50742-495LEVOLEUCOVORINlevoleucovorinIngenus Pharmaceuticals, LLCANDACurrent