药品注册申请号：076565
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 CAPSULE, EXTENDED RELEASE;ORAL EQ 37.5MG BASE No No AB 2010/06/28 2010/06/28 Prescription
002 VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 75MG BASE No No AB 2010/06/28 Prescription
003 VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 150MG BASE No No AB 2010/06/28 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
2024/08/12 SUPPL-23（补充） Approval Labeling STANDARD
2023/03/24 SUPPL-22（补充） Approval Labeling STANDARD
2023/03/24 SUPPL-21（补充） Approval Labeling STANDARD
2020/11/03 SUPPL-17（补充） Approval Labeling STANDARD
2020/11/03 SUPPL-16（补充） Approval Labeling STANDARD
2020/11/03 SUPPL-15（补充） Approval Labeling STANDARD
2020/11/03 SUPPL-14（补充） Approval Labeling STANDARD
2020/11/03 SUPPL-13（补充） Approval Labeling STANDARD
2015/10/01 SUPPL-11（补充） Approval Labeling STANDARD
2014/09/19 SUPPL-10（补充） Approval Labeling STANDARD
2014/09/19 SUPPL-6（补充） Approval Labeling STANDARD
2014/09/19 SUPPL-5（补充） Approval Labeling STANDARD
2014/09/19 SUPPL-4（补充） Approval Labeling STANDARD
2012/09/19 SUPPL-3（补充） Approval Labeling STANDARD
2010/06/28 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
无
与本品治疗等效的药品
活性成分:VENLAFAXINE HYDROCHLORIDE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;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
020699 001 NDA EFFEXOR XR VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 37.5MG BASE Prescription Yes No AB 1997/10/20 UPJOHN
076565 001 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 37.5MG BASE Prescription No No AB 2010/06/28 TEVA
078865 001 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 37.5MG BASE Prescription No No AB 2011/04/14 WOCKHARDT BIO AG
090174 001 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 37.5MG BASE Prescription No No AB 2011/04/14 ZYDUS PHARMS USA INC
200834 001 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 37.5MG BASE Prescription No No AB 2011/04/14 AUROBINDO PHARMA LTD
090071 001 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 37.5MG BASE Discontinued No No AB 2011/04/15 VALEANT PHARMS NORTH
078421 001 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 37.5MG BASE Prescription No No AB 2011/05/06 DR REDDYS LABS LTD
090899 001 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 37.5MG BASE Discontinued No No AB 2011/06/01 TORRENT
091123 001 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 37.5MG BASE Prescription No No AB 2011/07/11 ORBION PHARMS
204889 001 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 37.5MG BASE Prescription No No AB 2017/10/05 MACLEODS PHARMS LTD
201272 001 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 37.5MG BASE Prescription No No AB 2018/11/23 INTELLIPHARMACEUTICS
212277 001 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 37.5MG BASE Prescription No No AB 2019/07/08 ANNORA PHARMA
203332 001 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 37.5MG BASE Prescription No No AB 2020/03/12 INVENTIA HLTHCARE
214654 001 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 37.5MG BASE Prescription No No AB 2021/08/06 YICHANG HUMANWELL
200430 001 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 37.5MG BASE Discontinued No No AB 2023/04/04 NOSTRUM PHARMS LLC
217390 001 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 37.5MG BASE Prescription No No AB 2023/05/18 GRANULES
217767 001 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 37.5MG BASE Prescription No No AB 2024/06/06 ALEMBIC
活性成分:VENLAFAXINE HYDROCHLORIDE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;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
020699 002 NDA EFFEXOR XR VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 75MG BASE Prescription Yes No AB 1997/10/20 UPJOHN
076565 002 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 75MG BASE Prescription No No AB 2010/06/28 TEVA
078865 002 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 75MG BASE Prescription No No AB 2011/04/14 WOCKHARDT BIO AG
090174 002 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 75MG BASE Prescription No No AB 2011/04/14 ZYDUS PHARMS USA INC
200834 002 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 75MG BASE Prescription No No AB 2011/04/14 AUROBINDO PHARMA LTD
090071 002 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 75MG BASE Discontinued No No AB 2011/04/15 VALEANT PHARMS NORTH
078421 002 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 75MG BASE Prescription No No AB 2011/05/06 DR REDDYS LABS LTD
090899 002 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 75MG BASE Discontinued No No AB 2011/06/01 TORRENT
091123 002 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 75MG BASE Prescription No No AB 2011/07/11 ORBION PHARMS
204889 002 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 75MG BASE Prescription No No AB 2017/10/05 MACLEODS PHARMS LTD
201272 002 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 75MG BASE Prescription No No AB 2018/11/23 INTELLIPHARMACEUTICS
212277 002 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 75MG BASE Prescription No No AB 2019/07/08 ANNORA PHARMA
203332 002 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 75MG BASE Prescription No No AB 2020/03/12 INVENTIA HLTHCARE
214654 002 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 75MG BASE Prescription No No AB 2021/08/06 YICHANG HUMANWELL
200430 002 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 75MG BASE Discontinued No No AB 2023/04/04 NOSTRUM PHARMS LLC
217390 002 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 75MG BASE Prescription No No AB 2023/05/18 GRANULES
217767 002 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 75MG BASE Prescription No No AB 2024/06/06 ALEMBIC
活性成分:VENLAFAXINE HYDROCHLORIDE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:EQ 150MG 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
020699 004 NDA EFFEXOR XR VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 150MG BASE Prescription Yes Yes AB 1997/10/20 UPJOHN
076565 003 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 150MG BASE Prescription No No AB 2010/06/28 TEVA
078865 003 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 150MG BASE Prescription No No AB 2011/04/14 WOCKHARDT BIO AG
090174 003 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 150MG BASE Prescription No No AB 2011/04/14 ZYDUS PHARMS USA INC
200834 003 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 150MG BASE Prescription No No AB 2011/04/14 AUROBINDO PHARMA LTD
090071 003 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 150MG BASE Discontinued No No AB 2011/04/15 VALEANT PHARMS NORTH
078421 003 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 150MG BASE Prescription No No AB 2011/05/06 DR REDDYS LABS LTD
090899 003 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 150MG BASE Discontinued No No AB 2011/06/01 TORRENT
091123 003 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 150MG BASE Prescription No No AB 2011/07/11 ORBION PHARMS
204889 003 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 150MG BASE Prescription No No AB 2017/10/05 MACLEODS PHARMS LTD
201272 003 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 150MG BASE Prescription No No AB 2018/11/23 INTELLIPHARMACEUTICS
212277 003 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 150MG BASE Prescription No No AB 2019/07/08 ANNORA PHARMA
203332 003 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 150MG BASE Prescription No No AB 2020/03/12 INVENTIA HLTHCARE
214654 003 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 150MG BASE Prescription No No AB 2021/08/06 YICHANG HUMANWELL
200430 003 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 150MG BASE Discontinued No No AB 2023/04/04 NOSTRUM PHARMS LLC
217390 003 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 150MG BASE Prescription No No AB 2023/05/18 GRANULES
217767 003 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 150MG BASE Prescription No No AB 2024/06/06 ALEMBIC
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