FDA.reportPublic FDA data

Application 204890

Type
ANDA
Sponsor
QILU PHARM CO LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PEMETREXEDPEMETREXEDINJECTABLE;IV (INFUSION)EQ 100MG BASE/1VILENoNo
002PEMETREXEDPEMETREXED DISODIUMPOWDER;INTRAVENOUSEQ 500MG BASE/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50742-340PemetrexedPemetrexed disodiumIngenus Pharmaceuticals, LLCANDACurrent
50742-341PemetrexedPemetrexed disodiumIngenus Pharmaceuticals, LLCANDACurrent
67184-0503PemetrexedPemetrexed disodiumQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-0504PemetrexedPemetrexed disodiumQilu Pharmaceutical Co., Ltd.ANDACurrent
68001-538PemetrexedPemetrexed disodiumBluePioint LaboratoriesANDACurrent
68001-538PemetrexedPemetrexed disodiumBluePoint LaboratoriesANDACurrent
68001-538PemetrexedPemetrexed disodiumBluePoint LaboratoriesANDACurrent
68001-539PemetrexedPemetrexed disodiumBluePioint LaboratoriesANDACurrent
68001-539PemetrexedPemetrexed disodiumBluePoint LaboratoriesANDACurrent
68001-539PemetrexedPemetrexed disodiumBluePoint LaboratoriesANDACurrent