药品注册申请号:205930
申请类型:ANDA (仿制药申请)
申请人:LUPIN LTD
申请人全名:LUPIN LTD
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 PRASUGREL PRASUGREL HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE No No AB 2023/01/09 2023/01/09 Discontinued
002 PRASUGREL PRASUGREL HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE No No AB 2023/01/09 Discontinued
批准日期,申请提交历史,通知信,药品说明书,审评文件等信息
提交状态日期提交号审批结论申请内容分类审评优先级;罕用药状态通知信、审评文件、说明书、包装标签备注
2023/01/09 ORIG-1(原始申请) Approval STANDARD
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
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
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 COSETTE
205927 001 ANDA PRASUGREL PRASUGREL HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2017/07/12 MYLAN
205888 001 ANDA PRASUGREL PRASUGREL HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2017/10/16 AUROBINDO PHARMA
205897 001 ANDA PRASUGREL PRASUGREL HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2017/10/16 PANACEA
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
205930 001 ANDA PRASUGREL PRASUGREL HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE Discontinued No No AB 2023/01/09 LUPIN LTD
213315 001 ANDA PRASUGREL HYDROCHLORIDE PRASUGREL HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2023/08/28 UNICHEM
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 COSETTE
205927 002 ANDA PRASUGREL PRASUGREL HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2017/07/12 MYLAN
205888 002 ANDA PRASUGREL PRASUGREL HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2017/10/16 AUROBINDO PHARMA
205897 002 ANDA PRASUGREL PRASUGREL HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2017/10/16 PANACEA
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
205930 002 ANDA PRASUGREL PRASUGREL HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Discontinued No No AB 2023/01/09 LUPIN LTD
213315 002 ANDA PRASUGREL HYDROCHLORIDE PRASUGREL HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2023/08/28 UNICHEM
更多信息
药品NDC数据与药品包装、标签说明书
©2006-2024 DrugFuture->U.S. FDA Drugs Database