FDA.reportPublic FDA data

Application 210686

Type
ANDA
Sponsor
MSN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ABIRATERONE ACETATEABIRATERONE ACETATETABLET;ORAL250MGNoNo
002ABIRATERONE ACETATEABIRATERONE ACETATETABLET;ORAL500MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68001-489AbirateroneAbiraterone acetateBluePoint LaboratoriesANDACurrent
68001-489AbirateroneAbiraterone acetateBluePoint LaboratoriesANDACurrent
68001-489AbirateroneAbiraterone acetateBluePoint LaboratoriesANDACurrent
68001-489AbirateroneAbiraterone acetateBluePoint LaboratoriesANDACurrent
69539-049AbirateroneAbiraterone acetateMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-049AbirateroneAbiraterone acetateMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-049AbirateroneAbiraterone acetateMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-049AbirateroneAbiraterone acetateMSN LABORATORIES PRIVATE LIMITEDANDACurrent
72205-030AbirateroneAbiraterone acetateNovadoz Pharmaceuticals LLCANDACurrent
72205-030AbirateroneAbiraterone acetateNovadoz Pharmaceuticals LLCANDACurrent
72205-030AbirateroneAbiraterone acetateNovadoz Pharmaceuticals LLCANDACurrent