FDA.reportPublic FDA data

Application 214073

Type
ANDA
Sponsor
ZYDUS PHARMS USA INC

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70710-1654pemetrexedpemetrexed disodiumZydus Pharmaceuticals USA Inc.ANDACurrent
70710-1655pemetrexedpemetrexed disodiumZydus Pharmaceuticals USA Inc.ANDACurrent
70710-1674pemetrexedpemetrexed disodiumZydus Pharmaceuticals USA Inc.ANDACurrent
70771-1691pemetrexedpemetrexed disodiumZydus Lifesciences LimitedANDACurrent
70771-1692pemetrexedpemetrexed disodiumZydus Lifesciences LimitedANDACurrent
70771-1693pemetrexedpemetrexed disodiumZydus Lifesciences LimitedANDACurrent