FDA.reportPublic FDA data

Application 210448

Type
ANDA
Sponsor
APOTEX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUSULFANBUSULFANINJECTABLE;INJECTION6MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60505-6177BusulfanbusulfanApotex Corp.ANDACurrent
60505-6177BusulfanbusulfanApotex Corp.ANDACurrent
60505-6177BusulfanbusulfanApotex Corp.ANDACurrent
60505-6177BusulfanbusulfanApotex Corp.ANDACurrent
60505-6177BusulfanbusulfanApotex Corp.ANDACurrent