药品注册申请号：076690
申请类型：ANDA (仿制药申请)
申请人：TEVA
申请人全名：TEVA PHARMACEUTICALS USA INC
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 VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET;ORAL EQ 25MG BASE No No AB 2006/08/03 2006/08/03 Prescription
002 VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET;ORAL EQ 37.5MG BASE No No AB 2006/08/03 Prescription
003 VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET;ORAL EQ 50MG BASE No Yes AB 2006/08/03 Prescription
004 VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET;ORAL EQ 75MG BASE No No AB 2006/08/03 Prescription
005 VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET;ORAL EQ 100MG BASE No No AB 2006/08/03 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
2023/08/18 SUPPL-30（补充） Approval Labeling STANDARD
2023/08/09 SUPPL-29（补充） Approval Labeling STANDARD
2021/09/21 SUPPL-27（补充） Approval Labeling STANDARD
2020/04/14 SUPPL-23（补充） Approval Labeling STANDARD
2017/01/04 SUPPL-22（补充） Approval Labeling STANDARD
2014/07/17 SUPPL-20（补充） Approval Labeling STANDARD
2014/06/30 SUPPL-18（补充） Approval Labeling STANDARD
2012/09/19 SUPPL-17（补充） Approval Labeling STANDARD
2010/08/04 SUPPL-15（补充） Approval Manufacturing (CMC)
2010/03/15 SUPPL-16（补充） Approval Labeling
2009/07/22 SUPPL-14（补充） Approval Labeling
2009/01/27 SUPPL-11（补充） Approval Labeling
2008/08/13 SUPPL-10（补充） Approval Labeling
2008/08/13 SUPPL-8（补充） Approval Labeling
2008/02/05 SUPPL-6（补充） Approval Labeling
2008/02/05 SUPPL-5（补充） Approval Labeling
2007/07/12 SUPPL-3（补充） Approval Labeling
2006/08/03 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
无
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 2007/01/30**本条是由Drugfuture回溯的历史信息**
002 PC 2007/01/30**本条是由Drugfuture回溯的历史信息**
003 PC 2007/01/30**本条是由Drugfuture回溯的历史信息**
004 PC 2007/01/30**本条是由Drugfuture回溯的历史信息**
005 PC 2007/01/30**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:VENLAFAXINE HYDROCHLORIDE 剂型/给药途径:TABLET;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
076690 001 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2006/08/03 TEVA
077653 001 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2008/06/13 ZYDUS PHARMS USA
078301 001 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2008/06/13 DR REDDYS LABS LTD
078627 001 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2008/06/13 SUN PHARM INDS INC
078554 001 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2009/01/09 HERITAGE PHARMS
090555 001 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2010/04/07 AUROBINDO PHARMA
079098 001 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2010/05/11 AMNEAL PHARMS
078932 001 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2010/12/14 ALEMBIC PHARMS LTD
202036 001 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2015/05/28 YAOPHARMA CO LTD
206250 001 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2018/11/21 CADILA PHARMS LTD
活性成分:VENLAFAXINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:EQ 37.5MG 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
076690 002 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET;ORAL EQ 37.5MG BASE Prescription No No AB 2006/08/03 TEVA
077653 002 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET;ORAL EQ 37.5MG BASE Prescription No No AB 2008/06/13 ZYDUS PHARMS USA
078301 002 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET;ORAL EQ 37.5MG BASE Prescription No No AB 2008/06/13 DR REDDYS LABS LTD
078627 002 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET;ORAL EQ 37.5MG BASE Prescription No No AB 2008/06/13 SUN PHARM INDS INC
078554 002 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET;ORAL EQ 37.5MG BASE Prescription No No AB 2009/01/09 HERITAGE PHARMS
090555 002 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET;ORAL EQ 37.5MG BASE Prescription No No AB 2010/04/07 AUROBINDO PHARMA
079098 002 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET;ORAL EQ 37.5MG BASE Prescription No No AB 2010/05/11 AMNEAL PHARMS
078932 002 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET;ORAL EQ 37.5MG BASE Prescription No No AB 2010/12/14 ALEMBIC PHARMS LTD
202036 002 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET;ORAL EQ 37.5MG BASE Prescription No No AB 2015/05/28 YAOPHARMA CO LTD
206250 002 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET;ORAL EQ 37.5MG BASE Prescription No No AB 2018/11/21 CADILA PHARMS LTD
活性成分:VENLAFAXINE HYDROCHLORIDE 剂型/给药途径:TABLET;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
076690 003 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET;ORAL EQ 50MG BASE Prescription No Yes AB 2006/08/03 TEVA
077653 003 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2008/06/13 ZYDUS PHARMS USA
078301 003 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2008/06/13 DR REDDYS LABS LTD
078627 003 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2008/06/13 SUN PHARM INDS INC
078554 003 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2009/01/09 HERITAGE PHARMS
090555 003 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2010/04/07 AUROBINDO PHARMA
079098 003 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2010/05/11 AMNEAL PHARMS
078932 003 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2010/12/14 ALEMBIC PHARMS LTD
202036 003 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2015/05/28 YAOPHARMA CO LTD
206250 003 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2018/11/21 CADILA PHARMS LTD
活性成分:VENLAFAXINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:EQ 75MG 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
076690 004 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET;ORAL EQ 75MG BASE Prescription No No AB 2006/08/03 TEVA
077653 004 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET;ORAL EQ 75MG BASE Prescription No No AB 2008/06/13 ZYDUS PHARMS USA
078301 004 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET;ORAL EQ 75MG BASE Prescription No No AB 2008/06/13 DR REDDYS LABS LTD
078627 004 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET;ORAL EQ 75MG BASE Prescription No No AB 2008/06/13 SUN PHARM INDS INC
078554 004 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET;ORAL EQ 75MG BASE Prescription No No AB 2009/01/09 HERITAGE PHARMS
090555 004 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET;ORAL EQ 75MG BASE Prescription No No AB 2010/04/07 AUROBINDO PHARMA
079098 004 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET;ORAL EQ 75MG BASE Prescription No No AB 2010/05/11 AMNEAL PHARMS
078932 004 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET;ORAL EQ 75MG BASE Prescription No No AB 2010/12/14 ALEMBIC PHARMS LTD
202036 004 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET;ORAL EQ 75MG BASE Prescription No No AB 2015/05/28 YAOPHARMA CO LTD
206250 004 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET;ORAL EQ 75MG BASE Prescription No No AB 2018/11/21 CADILA PHARMS LTD
活性成分:VENLAFAXINE HYDROCHLORIDE 剂型/给药途径:TABLET;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
076690 005 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2006/08/03 TEVA
077653 005 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2008/06/13 ZYDUS PHARMS USA
078301 005 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2008/06/13 DR REDDYS LABS LTD
078627 005 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2008/06/13 SUN PHARM INDS INC
078554 005 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2009/01/09 HERITAGE PHARMS
090555 005 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2010/04/07 AUROBINDO PHARMA
079098 005 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2010/05/11 AMNEAL PHARMS
078932 005 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2010/12/14 ALEMBIC PHARMS LTD
202036 005 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2015/05/28 YAOPHARMA CO LTD
206250 005 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2018/11/21 CADILA PHARMS LTD
更多信息
药品NDC数据与药品包装、标签说明书
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