商品名 | 申请号 | 产品号 | 申请类型 | 活性成分 | 剂型/给药途径 | 规格/剂量 | RLD | RS | 申请号原始批准/暂定批准日期 | 产品号批准日期 | 申请人 | 市场状态 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
ABIRATERONE ACETATE | 208339 | 001 | ANDA | ABIRATERONE ACETATE | TABLET;ORAL | 250MG | No | No | 2018/10/31 | 2018/10/31 | HIKMA | Prescription |
ABIRATERONE ACETATE | 208432 | 001 | ANDA | ABIRATERONE ACETATE | TABLET;ORAL | 250MG | No | No | 2018/10/31 | 2018/10/31 | TEVA PHARMS USA | Prescription |
ABIRATERONE ACETATE | 208446 | 001 | ANDA | ABIRATERONE ACETATE | TABLET;ORAL | 250MG | No | No | 2018/10/31 | 2018/10/31 | MYLAN | Prescription |
ABIRATERONE ACETATE | 208446 | 002 | ANDA | ABIRATERONE ACETATE | TABLET;ORAL | 500MG | No | No | 2018/10/31 | 2020/12/14 | MYLAN | Prescription |
ABIRATERONE ACETATE | 208453 | 001 | ANDA | ABIRATERONE ACETATE | TABLET;ORAL | 250MG | No | No | 2018/10/31 | 2018/10/31 | APOTEX | Prescription |
ABIRATERONE ACETATE | 208327 | 001 | ANDA | ABIRATERONE ACETATE | TABLET;ORAL | 250MG | No | No | 2019/01/07 | 2019/01/07 | AMNEAL PHARMS | Prescription |
ABIRATERONE ACETATE | 208327 | 002 | ANDA | ABIRATERONE ACETATE | TABLET;ORAL | 500MG | No | No | 2019/01/07 | 2020/12/23 | AMNEAL PHARMS | Prescription |
ABIRATERONE ACETATE | 208371 | 001 | ANDA | ABIRATERONE ACETATE | TABLET;ORAL | 250MG | No | No | 2019/02/25 | 2019/02/25 | RISING | Prescription |
ABIRATERONE ACETATE | 208380 | 001 | ANDA | ABIRATERONE ACETATE | TABLET;ORAL | 250MG | No | No | 2019/02/27 | 2019/02/27 | WOCKHARDT BIO AG | Prescription |
ABIRATERONE ACETATE | 210686 | 001 | ANDA | ABIRATERONE ACETATE | TABLET;ORAL | 250MG | No | No | 2019/07/10 | 2019/07/10 | MSN | Prescription |
ABIRATERONE ACETATE | 210686 | 002 | ANDA | ABIRATERONE ACETATE | TABLET;ORAL | 500MG | No | No | 2019/07/10 | 2024/04/24 | MSN | Prescription |
ABIRATERONE ACETATE | 212462 | 001 | ANDA | ABIRATERONE ACETATE | TABLET;ORAL | 250MG | No | No | 2019/09/27 | 2019/09/27 | QILU | Prescription |
ABIRATERONE ACETATE | 212462 | 002 | ANDA | ABIRATERONE ACETATE | TABLET;ORAL | 500MG | No | No | 2019/09/27 | 2021/06/25 | QILU | Prescription |
ABIRATERONE ACETATE | 209227 | 001 | ANDA | ABIRATERONE ACETATE | TABLET;ORAL | 250MG | No | No | 2019/10/16 | 2019/10/16 | GLENMARK SPECLT | Prescription |
ABIRATERONE ACETATE | 209227 | 002 | ANDA | ABIRATERONE ACETATE | TABLET;ORAL | 500MG | No | No | 2019/10/16 | 2022/05/19 | GLENMARK SPECLT | Prescription |
ABIRATERONE ACETATE | 208416 | 001 | ANDA | ABIRATERONE ACETATE | TABLET;ORAL | 250MG | No | No | 2020/05/18 | 2020/05/18 | DR REDDYS | Prescription |
ABIRATERONE ACETATE | 208416 | 002 | ANDA | ABIRATERONE ACETATE | TABLET;ORAL | 500MG | No | No | 2020/05/18 | 2023/09/01 | DR REDDYS | Prescription |
ABIRATERONE ACETATE | 215947 | 001 | ANDA | ABIRATERONE ACETATE | TABLET;ORAL | 250MG | No | No | 2022/01/05 | 2022/01/05 | NOVUGEN | Prescription |
ABIRATERONE ACETATE | 215947 | 002 | ANDA | ABIRATERONE ACETATE | TABLET;ORAL | 500MG | No | No | 2022/01/05 | 2022/01/05 | NOVUGEN | Prescription |
ABIRATERONE ACETATE | 212206 | 001 | ANDA | ABIRATERONE ACETATE | TABLET;ORAL | 125MG | No | No | 2022/06/24 | 2022/06/24 | TEVA PHARMS USA | Discontinued |