药品注册申请号:022307
申请类型:NDA (新药申请)
申请人:ELI LILLY AND CO
申请人全名:ELI LILLY AND CO
产品信息
产品号商品名活性成分剂型/给药途径规格/剂量参比药物(RLD)生物等效参考标准(RS)治疗等效代码该申请号批准日期该产品号批准日期市场状态
001 EFFIENT PRASUGREL HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE Yes No AB 2009/07/10 2009/07/10 Prescription
002 EFFIENT PRASUGREL HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Yes Yes AB 2009/07/10 Prescription
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2019/03/28 SUPPL 16 Approval Labeling STANDARD
2018/03/09 SUPPL 15 Approval Labeling STANDARD
2016/07/12 SUPPL 14 Approval Efficacy PRIORITY
2016/01/14 SUPPL 13 Approval Labeling STANDARD
2015/07/07 SUPPL 12 Approval Labeling STANDARD
2013/11/19 SUPPL 10 Approval Labeling STANDARD
2013/10/16 SUPPL 8 Approval Efficacy STANDARD
2012/11/30 SUPPL 7 Approval Labeling UNKNOWN
2012/03/23 SUPPL 6 Approval REMS N/A
2011/09/27 SUPPL 3 Approval Labeling UNKNOWN
2010/12/06 SUPPL 2 Approval Labeling UNKNOWN
2010/04/16 SUPPL 1 Approval Manufacturing (CMC) PRIORITY
2009/07/10 ORIG 1 Approval Type 1 - New Molecular Entity PRIORITY
与本品相关的专利信息(来自FDA橙皮书Orange Book)
关联产品号专利号专利过期日是否物质专利是否产品专利专利用途代码撤销请求提交日期专利下载备注
001 5288726 2017/04/14 Y Y U-991 PDF格式**本条是由Drugfuture回溯的历史信息**
8404703 2022/11/12 U-1381 PDF格式**本条是由Drugfuture回溯的历史信息**
8569325 2022/11/12 U-1381 PDF格式**本条是由Drugfuture回溯的历史信息**
002 5288726 2017/04/14 Y Y U-991 PDF格式**本条是由Drugfuture回溯的历史信息**
8404703 2022/11/12 U-1381 PDF格式**本条是由Drugfuture回溯的历史信息**
8569325 2022/11/12 U-1381 PDF格式**本条是由Drugfuture回溯的历史信息**
与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
001 M-182 2019/07/12
PED 2020/01/12
002 M-182 2019/07/12
PED 2020/01/12
001 NCE 2014/07/10**本条是由Drugfuture回溯的历史信息**
002 NCE 2014/07/10**本条是由Drugfuture回溯的历史信息**
与本品治疗等效的药品
活性成分:PRASUGREL HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:EQ 5MG BASE 治疗等效代码:AB
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
022307 001 NDA EFFIENT PRASUGREL HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE Prescription Yes No AB 2009/07/10 ELI LILLY AND CO
205927 001 ANDA PRASUGREL PRASUGREL HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2017/07/12 MYLAN
205790 001 ANDA PRASUGREL PRASUGREL HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2017/10/16 USPHARMA WINDLAS
205888 001 ANDA PRASUGREL PRASUGREL HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2017/10/16 AUROBINDO PHARMA LTD
205897 001 ANDA PRASUGREL PRASUGREL HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2017/10/16 PANACEA BIOTEC LTD
205987 001 ANDA PRASUGREL PRASUGREL HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2018/02/02 ACCORD HLTHCARE
205913 001 ANDA PRASUGREL PRASUGREL HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2018/06/19 AMNEAL PHARMS
206021 001 ANDA PRASUGREL PRASUGREL HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2019/01/16 HEC PHARM
活性成分:PRASUGREL HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:EQ 10MG BASE 治疗等效代码:AB
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
022307 002 NDA EFFIENT PRASUGREL HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription Yes Yes AB 2009/07/10 ELI LILLY AND CO
205927 002 ANDA PRASUGREL PRASUGREL HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2017/07/12 MYLAN
205790 002 ANDA PRASUGREL PRASUGREL HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2017/10/16 USPHARMA WINDLAS
205888 002 ANDA PRASUGREL PRASUGREL HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2017/10/16 AUROBINDO PHARMA LTD
205897 002 ANDA PRASUGREL PRASUGREL HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2017/10/16 PANACEA BIOTEC LTD
205987 002 ANDA PRASUGREL PRASUGREL HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2018/02/02 ACCORD HLTHCARE
205913 002 ANDA PRASUGREL PRASUGREL HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2018/06/19 AMNEAL PHARMS
206021 002 ANDA PRASUGREL PRASUGREL HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2019/01/16 HEC PHARM
更多信息
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