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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
ICOSAPENT ETHYL | 209457 | 001 | ANDA | ICOSAPENT ETHYL | CAPSULE;ORAL | 1GM | No | No | 2020/05/21 | 2020/05/21 | HIKMA | Prescription |
ICOSAPENT ETHYL | 209457 | 002 | ANDA | ICOSAPENT ETHYL | CAPSULE;ORAL | 500MG | No | No | 2020/05/21 | 2023/03/08 | HIKMA | Prescription |
ICOSAPENT ETHYL | 209499 | 001 | ANDA | ICOSAPENT ETHYL | CAPSULE;ORAL | 1GM | No | No | 2020/08/07 | 2020/08/07 | DR REDDYS | Prescription |
ICOSAPENT ETHYL | 209499 | 002 | ANDA | ICOSAPENT ETHYL | CAPSULE;ORAL | 500MG | No | No | 2020/08/07 | 2023/03/08 | DR REDDYS | Prescription |
ICOSAPENT ETHYL | 209525 | 001 | ANDA | ICOSAPENT ETHYL | CAPSULE;ORAL | 500MG | No | No | 2020/09/11 | 2020/09/11 | TEVA PHARMS USA | Prescription |
ICOSAPENT ETHYL | 209525 | 002 | ANDA | ICOSAPENT ETHYL | CAPSULE;ORAL | 1GM | No | No | 2020/09/11 | 2020/09/11 | TEVA PHARMS USA | Prescription |
ICOSAPENT ETHYL | 209437 | 001 | ANDA | ICOSAPENT ETHYL | CAPSULE;ORAL | 1GM | No | No | 2021/06/30 | 2021/06/30 | APOTEX | Prescription |
ICOSAPENT ETHYL | 209499 | 001 | ANDA | ICOSAPENT ETHYL | CAPSULE;ORAL | 1GM | No | No | 2023/03/08 | 2020/08/07 | DR REDDYS | Prescription |
ICOSAPENT ETHYL | 209499 | 002 | ANDA | ICOSAPENT ETHYL | CAPSULE;ORAL | 500MG | No | No | 2023/03/08 | 2023/03/08 | DR REDDYS | Prescription |
ICOSAPENT ETHYL | 217656 | 001 | ANDA | ICOSAPENT ETHYL | CAPSULE;ORAL | 500MG | No | No | 2023/04/20 | 2023/04/20 | ZYDUS LIFESCIENCES | Prescription |
ICOSAPENT ETHYL | 217656 | 002 | ANDA | ICOSAPENT ETHYL | CAPSULE;ORAL | 1GM | No | No | 2023/04/20 | 2023/04/20 | ZYDUS LIFESCIENCES | Prescription |
ICOSAPENT ETHYL | 217844 | 001 | ANDA | ICOSAPENT ETHYL | CAPSULE;ORAL | 500MG | No | No | 2023/09/22 | 2023/09/22 | STRIDES SOFTGELS | Prescription |
ICOSAPENT ETHYL | 217844 | 002 | ANDA | ICOSAPENT ETHYL | CAPSULE;ORAL | 1GM | No | No | 2023/09/22 | 2023/09/22 | STRIDES SOFTGELS | Prescription |
ICOSAPENT ETHYL | 216811 | 001 | ANDA | ICOSAPENT ETHYL | CAPSULE;ORAL | 500MG | No | No | 2023/12/07 | 2023/12/07 | ASCENT PHARMS INC | Prescription |
ICOSAPENT ETHYL | 216811 | 002 | ANDA | ICOSAPENT ETHYL | CAPSULE;ORAL | 1GM | No | No | 2023/12/07 | 2024/02/16 | ASCENT PHARMS INC | Prescription |
ICOSAPENT ETHYL | 217919 | 001 | ANDA | ICOSAPENT ETHYL | CAPSULE;ORAL | 500MG | No | No | 2023/12/22 | 2023/12/22 | HUMANWELL PURACAP | Prescription |
ICOSAPENT ETHYL | 217919 | 002 | ANDA | ICOSAPENT ETHYL | CAPSULE;ORAL | 1GM | No | No | 2023/12/22 | 2023/12/22 | HUMANWELL PURACAP | Prescription |
ICOSAPENT ETHYL | 216811 | 001 | ANDA | ICOSAPENT ETHYL | CAPSULE;ORAL | 500MG | No | No | 2024/02/16 | 2023/12/07 | ASCENT PHARMS INC | Prescription |
ICOSAPENT ETHYL | 216811 | 002 | ANDA | ICOSAPENT ETHYL | CAPSULE;ORAL | 1GM | No | No | 2024/02/16 | 2024/02/16 | ASCENT PHARMS INC | Prescription |
ICOSAPENT ETHYL | 218899 | 001 | ANDA | ICOSAPENT ETHYL | CAPSULE;ORAL | 1GM | No | No | 2024/11/20 | 2024/11/20 | QILU | Prescription |