FDA.reportPublic FDA data

Application 207548

Type
ANDA
Sponsor
AMNEAL

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70121-1572Levoleucovorin CalciumLevoleucovorinAmneal Pharmaceuticals LLCANDACurrent
70121-1572Levoleucovorin CalciumLevoleucovorinAmneal Pharmaceuticals LLCANDACurrent
70121-1572Levoleucovorin CalciumLevoleucovorinAmneal Pharmaceuticals LLCANDACurrent
70121-1572Levoleucovorin CalciumLevoleucovorinAmneal Pharmaceuticals LLCANDACurrent
70121-1572Levoleucovorin CalciumLevoleucovorinAmneal Biosciences LLCANDACurrent
70121-1572Levoleucovorin CalciumLevoleucovorinAmneal Pharmaceuticals LLCANDACurrent