FDA.reportPublic FDA data

Application 215947

Type
ANDA
Sponsor
ONCOGEN PHARMA

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
63629-9429Abiraterone Acetateabiraterone acetateBryant Ranch PrepackANDACurrent
63629-9430Abiraterone Acetateabiraterone acetateBryant Ranch PrepackANDACurrent
82293-001Abiraterone Acetateabiraterone acetateNovugen Pharma (USA) LLCANDACurrent
82293-002Abiraterone Acetateabiraterone acetateNovugen Pharma (USA) LLCANDACurrent