药品注册申请号:204172
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 DESVENLAFAXINE SUCCINATE DESVENLAFAXINE SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 50MG BASE No No AB 2015/06/29 2015/06/29 Prescription
002 DESVENLAFAXINE SUCCINATE DESVENLAFAXINE SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 100MG BASE No No AB 2015/06/29 Prescription
003 DESVENLAFAXINE SUCCINATE DESVENLAFAXINE SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 25MG BASE No No AB 2022/04/13 Prescription
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
2022/04/13 SUPPL-20(补充) Approval Labeling STANDARD
2016/07/15 SUPPL-1(补充) Approval Labeling STANDARD
2015/06/29 ORIG-1(原始申请) Approval
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
001 PC 2017/08/28**本条是由Drugfuture回溯的历史信息**
002 PC 2017/08/28**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:DESVENLAFAXINE SUCCINATE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:EQ 50MG 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
021992 001 NDA PRISTIQ DESVENLAFAXINE SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 50MG BASE Prescription Yes No AB 2008/02/29 PF PRISM CV
204003 001 ANDA DESVENLAFAXINE SUCCINATE DESVENLAFAXINE SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 50MG BASE Prescription No No AB 2015/06/29 ALEMBIC
204028 001 ANDA DESVENLAFAXINE SUCCINATE DESVENLAFAXINE SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 50MG BASE Prescription No No AB 2015/06/29 RUBICON
204172 001 ANDA DESVENLAFAXINE SUCCINATE DESVENLAFAXINE SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 50MG BASE Prescription No No AB 2015/06/29 LUPIN LTD
204082 001 ANDA DESVENLAFAXINE SUCCINATE DESVENLAFAXINE SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 50MG BASE Prescription No No AB 2016/02/16 HIKMA
204065 002 ANDA DESVENLAFAXINE SUCCINATE DESVENLAFAXINE SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 50MG BASE Prescription No No AB 2016/07/29 ACTAVIS LABS FL
204020 001 ANDA DESVENLAFAXINE SUCCINATE DESVENLAFAXINE SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 50MG BASE Prescription No No AB 2017/10/11 ZYDUS PHARMS
210014 001 ANDA DESVENLAFAXINE SUCCINATE DESVENLAFAXINE SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 50MG BASE Prescription No No AB 2018/10/01 YICHANG HUMANWELL
204805 001 ANDA DESVENLAFAXINE SUCCINATE DESVENLAFAXINE SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 50MG BASE Prescription No No AB 2019/05/07 INTELLIPHARMACEUTICS
活性成分:DESVENLAFAXINE SUCCINATE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:EQ 100MG 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
021992 002 NDA PRISTIQ DESVENLAFAXINE SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 100MG BASE Prescription Yes Yes AB 2008/02/29 PF PRISM CV
204003 002 ANDA DESVENLAFAXINE SUCCINATE DESVENLAFAXINE SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 100MG BASE Prescription No No AB 2015/06/29 ALEMBIC
204028 002 ANDA DESVENLAFAXINE SUCCINATE DESVENLAFAXINE SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 100MG BASE Prescription No No AB 2015/06/29 RUBICON
204172 002 ANDA DESVENLAFAXINE SUCCINATE DESVENLAFAXINE SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 100MG BASE Prescription No No AB 2015/06/29 LUPIN LTD
204083 001 ANDA DESVENLAFAXINE SUCCINATE DESVENLAFAXINE SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 100MG BASE Prescription No No AB 2016/02/16 HIKMA
204065 003 ANDA DESVENLAFAXINE SUCCINATE DESVENLAFAXINE SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 100MG BASE Prescription No No AB 2016/07/29 ACTAVIS LABS FL
204020 002 ANDA DESVENLAFAXINE SUCCINATE DESVENLAFAXINE SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 100MG BASE Prescription No No AB 2017/10/11 ZYDUS PHARMS
210014 002 ANDA DESVENLAFAXINE SUCCINATE DESVENLAFAXINE SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 100MG BASE Prescription No No AB 2018/10/01 YICHANG HUMANWELL
204805 002 ANDA DESVENLAFAXINE SUCCINATE DESVENLAFAXINE SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 100MG BASE Prescription No No AB 2019/05/07 INTELLIPHARMACEUTICS
活性成分:DESVENLAFAXINE SUCCINATE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:EQ 25MG 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
021992 003 NDA PRISTIQ DESVENLAFAXINE SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 25MG BASE Prescription Yes No AB 2014/08/20 PF PRISM CV
204065 001 ANDA DESVENLAFAXINE SUCCINATE DESVENLAFAXINE SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 25MG BASE Prescription No No AB 2016/07/29 ACTAVIS LABS FL
204082 002 ANDA DESVENLAFAXINE SUCCINATE DESVENLAFAXINE SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 25MG BASE Prescription No No AB 2017/08/28 HIKMA
204003 003 ANDA DESVENLAFAXINE SUCCINATE DESVENLAFAXINE SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 25MG BASE Prescription No No AB 2018/09/14 ALEMBIC
210014 003 ANDA DESVENLAFAXINE SUCCINATE DESVENLAFAXINE SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 25MG BASE Prescription No No AB 2020/10/13 YICHANG HUMANWELL
204172 003 ANDA DESVENLAFAXINE SUCCINATE DESVENLAFAXINE SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 25MG BASE Prescription No No AB 2022/04/13 LUPIN LTD
204020 003 ANDA DESVENLAFAXINE SUCCINATE DESVENLAFAXINE SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 25MG BASE Prescription No No AB 2022/11/30 ZYDUS PHARMS
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