FDA.reportPublic FDA data

Application 208339

Type
ANDA
Sponsor
HIKMA PHARMS

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
0143-9597AbirateroneAbiraterone acetateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9597AbirateroneAbiraterone acetateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9597AbirateroneAbiraterone acetateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9597AbirateroneAbiraterone acetateWest-Ward Pharmaceuticals CorpANDACurrent
0143-9597AbirateroneAbiraterone acetateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9597AbirateroneAbiraterone acetateHikma Pharmaceuticals USA Inc.ANDACurrent
72789-213AbirateroneAbiraterone acetatePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-213AbirateroneAbiraterone acetatePD-Rx Pharmaceuticals, Inc.ANDACurrent
82249-010AbirateroneAbiraterone acetateCivicaScript, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
56278ORIG2018-11-05