FDA.reportPublic FDA data

Application 210721

Type
ANDA
Sponsor
APOTEX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CYCLOSPORINECYCLOSPORINECAPSULE;ORAL25MGNoNo
002CYCLOSPORINECYCLOSPORINECAPSULE;ORAL50MGNoNo
003CYCLOSPORINECYCLOSPORINECAPSULE;ORAL100MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60505-4630CycloSPORINE, ModfiedCyclosporineApotex Corp.ANDACurrent
60505-4630CycloSPORINE, ModfiedCyclosporineApotex Corp.ANDACurrent
60505-4630CycloSPORINE, ModfiedCyclosporineApotex Corp.ANDACurrent
60505-4630CycloSPORINE, ModfiedCyclosporineApotex Corp.ANDACurrent
60505-4631CycloSPORINE, ModfiedCyclosporineApotex Corp.ANDACurrent
60505-4631CycloSPORINE, ModfiedCyclosporineApotex Corp.ANDACurrent
60505-4631CycloSPORINE, ModfiedCyclosporineApotex Corp.ANDACurrent
60505-4631CycloSPORINE, ModfiedCyclosporineApotex Corp.ANDACurrent
60505-4632CycloSPORINE, ModfiedCyclosporineApotex Corp.ANDACurrent
60505-4632CycloSPORINE, ModfiedCyclosporineApotex Corp.ANDACurrent
60505-4632CycloSPORINE, ModfiedCyclosporineApotex Corp.ANDACurrent
60505-4632CycloSPORINE, ModfiedCyclosporineApotex Corp.ANDACurrent