FDA.reportPublic FDA data

Application 203774

Type
ANDA
Sponsor
APOTEX INC

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60505-6065PemetrexedPemetrexed disodiumApotex CorpANDACurrent
60505-6065PemetrexedPemetrexed disodiumApotex CorpANDACurrent
60505-6066PemetrexedPemetrexed disodiumApotex CorpANDACurrent
60505-6066PemetrexedPemetrexed disodiumApotex CorpANDACurrent
68001-543PemetrexedPemetrexed disodiumBluePoint LaboratoriesANDACurrent
68001-544PemetrexedPemetrexed disodiumBluePoint LaboratoriesANDACurrent