FDA.reportPublic FDA data

Application 208453

Type
ANDA
Sponsor
APOTEX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ABIRATERONE ACETATEABIRATERONE ACETATETABLET;ORAL250MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6948Abiraterone AcetateAbiraterone AcetateMajor PharmaceuticalsANDACurrent
0904-6948Abiraterone AcetateAbiraterone AcetateMajor PharmaceuticalsANDACurrent
60505-4327Abiraterone AcetateAbiraterone AcetateApotex Corp.ANDACurrent
60505-4327Abiraterone AcetateAbiraterone AcetateApotex Corp.ANDACurrent
60505-4327Abiraterone AcetateAbiraterone AcetateApotex Corp.ANDACurrent
60505-4327Abiraterone AcetateAbiraterone AcetateApotex Corp.ANDACurrent
60505-4327Abiraterone AcetateAbiraterone AcetateApotex Corp.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
56279ORIG2018-11-05