FDA.reportPublic FDA data

Application 214632

Type
ANDA
Sponsor
EUGIA PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PEMETREXED DISODIUMPEMETREXED DISODIUMPOWDER;INTRAVENOUSEQ 100MG BASE/VIALNoNo
002PEMETREXED DISODIUMPEMETREXED DISODIUMPOWDER;INTRAVENOUSEQ 500MG BASE/VIALNoNo
003PEMETREXED DISODIUMPEMETREXED DISODIUMPOWDER;INTRAVENOUSEQ 1GM BASE/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55150-381PemetrexedPemetrexedAuroMedics Pharma LLCANDACurrent
55150-381PemetrexedPemetrexedEugia US LLCANDACurrent
55150-381PemetrexedPemetrexedEugia US LLCANDACurrent
55150-381PemetrexedPemetrexedAuroMedics Pharma LLCANDACurrent
55150-382PemetrexedPemetrexedAuroMedics Pharma LLCANDACurrent
55150-382PemetrexedPemetrexedAuroMedics Pharma LLCANDACurrent
55150-382PemetrexedPemetrexedEugia US LLCANDACurrent
55150-382PemetrexedPemetrexedEugia US LLCANDACurrent
55150-383PemetrexedPemetrexedAuroMedics Pharma LLCANDACurrent
55150-383PemetrexedPemetrexedEugia US LLCANDACurrent
55150-383PemetrexedPemetrexedEugia US LLCANDACurrent
55150-383PemetrexedPemetrexedAuroMedics Pharma LLCANDACurrent
68001-535PemetrexedPemetrexedBluePoint LaboratiesANDACurrent
68001-535PemetrexedPemetrexedBluePoint LaboratoriesANDACurrent
68001-536PemetrexedPemetrexedBluePoint LaboratiesANDACurrent
68001-536PemetrexedPemetrexedBluePoint LaboratoriesANDACurrent
68001-537PemetrexedPemetrexedBluePoint LaboratiesANDACurrent
68001-537PemetrexedPemetrexedBluePoint LaboratoriesANDACurrent