FDA.reportPublic FDA data

Application 211132

Type
ANDA
Sponsor
RICONPHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEUCOVORIN CALCIUMLEUCOVORIN CALCIUMTABLET;ORALEQ 5MG BASENoNo
002LEUCOVORIN CALCIUMLEUCOVORIN CALCIUMTABLET;ORALEQ 10MG BASENoNo
003LEUCOVORIN CALCIUMLEUCOVORIN CALCIUMTABLET;ORALEQ 15MG BASENoNo
004LEUCOVORIN CALCIUMLEUCOVORIN CALCIUMTABLET;ORALEQ 25MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50742-181Leucovorin CalciumLeucovorin CalciumIngenus Pharmaceuticals, LLCANDACurrent
50742-181Leucovorin CalciumLeucovorin CalciumIngenus Pharmaceuticals, LLCANDACurrent
50742-182Leucovorin CalciumLeucovorin CalciumIngenus Pharmaceuticals, LLCANDACurrent
50742-182Leucovorin CalciumLeucovorin CalciumIngenus Pharmaceuticals, LLCANDACurrent
50742-183Leucovorin CalciumLeucovorin CalciumIngenus Pharmaceuticals, LLCANDACurrent
50742-183Leucovorin CalciumLeucovorin CalciumIngenus Pharmaceuticals, LLCANDACurrent
50742-184Leucovorin CalciumLeucovorin CalciumIngenus Pharmaceuticals, LLCANDACurrent
50742-184Leucovorin CalciumLeucovorin CalciumIngenus Pharmaceuticals, LLCANDACurrent