FDA.reportPublic FDA data

Application 065040

Type
ANDA
Sponsor
APOTEX

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60505-0133CyclosporineCyclosporineApotex Corp.ANDACurrent
60505-0133CyclosporineCyclosporineApotex Corp.ANDACurrent
60505-0133CyclosporineCyclosporineApotex Corp.ANDACurrent
60505-0134CyclosporineCyclosporineApotex Corp.ANDACurrent
60505-0134CyclosporineCyclosporineApotex Corp.ANDACurrent
60505-0134CyclosporineCyclosporineApotex Corp.ANDACurrent
68084-879CyclosporineCyclosporineAmerican Health PackagingANDACurrent
68084-879CyclosporineCyclosporineAmerican Health PackagingANDACurrent
68084-879CyclosporineCyclosporineAmerican Health PackagingANDACurrent
68084-921CyclosporineCyclosporineAmerican Health PackagingANDACurrent
68084-921CyclosporineCyclosporineAmerican Health PackagingANDACurrent
68084-921CyclosporineCyclosporineAmerican Health PackagingANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22305ORIG2005-07-22
30632ORIG2003-04-09