药品注册申请号：022104
申请类型：NDA (新药申请)
申请人：OSMOTICA PHARM US
申请人全名：OSMOTICA PHARMACEUTICAL US LLC
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, EXTENDED RELEASE;ORAL EQ 37.5MG BASE Yes No AB 2008/05/20 2008/05/20 Prescription
002 VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 75MG BASE Yes No AB 2008/05/20 Prescription
003 VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 150MG BASE Yes Yes AB 2008/05/20 Prescription
004 VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 225MG BASE Yes No AB 2008/05/20 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-23（补充） Approval Labeling STANDARD
2021/09/20 SUPPL-21（补充） Approval Labeling STANDARD
2017/12/19 SUPPL-16（补充） Approval Labeling 901 REQUIRED
2017/01/04 SUPPL-15（补充） Approval Labeling 901 REQUIRED
2016/12/14 SUPPL-13（补充） Approval Manufacturing (CMC) STANDARD
2016/06/21 SUPPL-11（补充） Approval Manufacturing (CMC) STANDARD
2016/03/24 SUPPL-12（补充） Approval Manufacturing (CMC) STANDARD
2014/07/18 SUPPL-10（补充） Approval Labeling 901 REQUIRED
2012/12/11 SUPPL-9（补充） Approval Labeling STANDARD
2012/07/31 SUPPL-7（补充） Approval REMS N/A
2012/05/02 SUPPL-8（补充） Approval Labeling STANDARD
2009/02/27 SUPPL-2（补充） Approval Manufacturing (CMC) N/A
2009/01/30 SUPPL-3（补充） Approval Labeling STANDARD
2008/05/20 ORIG-1（原始申请） Approval Type 3 - New Dosage Form 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
001 6403120 2017/03/20 U-839 U-535 PDF格式**本条是由Drugfuture回溯的历史信息**
6419958 2017/03/20 U-535 U-839 PDF格式**本条是由Drugfuture回溯的历史信息**
002 6403120 2017/03/20 U-839 U-535 PDF格式**本条是由Drugfuture回溯的历史信息**
6419958 2017/03/20 U-535 U-839 PDF格式**本条是由Drugfuture回溯的历史信息**
003 6403120 2017/03/20 U-535 U-839 PDF格式**本条是由Drugfuture回溯的历史信息**
6419958 2017/03/20 U-839 U-535 PDF格式**本条是由Drugfuture回溯的历史信息**
004 6403120 2017/03/20 U-839 U-535 PDF格式**本条是由Drugfuture回溯的历史信息**
6419958 2017/03/20 U-535 U-839 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
无
与本品治疗等效的药品
活性成分:VENLAFAXINE HYDROCHLORIDE 剂型/给药途径:TABLET, 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
022104 001 NDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 37.5MG BASE Prescription Yes No AB 2008/05/20 OSMOTICA PHARM US
091272 001 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 37.5MG BASE Discontinued No No AB 2010/08/18 SUN PHARM
214419 001 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 37.5MG BASE Prescription No No AB 2020/10/21 ASCENT PHARMS INC
214127 001 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 37.5MG BASE Prescription No No AB 2021/06/10 ALKEM LABS LTD
215622 001 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 37.5MG BASE Prescription No No AB 2022/08/30 ZYDUS PHARMS
216044 001 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 37.5MG BASE Prescription No No AB 2022/11/28 UNIQUE
214691 001 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 37.5MG BASE Prescription No No AB 2023/04/12 AJANTA PHARMA LTD
活性成分:VENLAFAXINE HYDROCHLORIDE 剂型/给药途径:TABLET, 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
022104 002 NDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 75MG BASE Prescription Yes No AB 2008/05/20 OSMOTICA PHARM US
091272 002 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 75MG BASE Discontinued No No AB 2010/08/18 SUN PHARM
211323 001 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 75MG BASE Prescription No No AB 2019/08/29 CADILA PHARMS LTD
214419 002 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 75MG BASE Prescription No No AB 2020/10/21 ASCENT PHARMS INC
213927 001 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 75MG BASE Prescription No No AB 2021/01/21 DEXCEL
214127 002 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 75MG BASE Prescription No No AB 2021/06/10 ALKEM LABS LTD
214423 001 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 75MG BASE Discontinued No No AB 2022/01/04 SWISS PHARM
215622 002 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 75MG BASE Prescription No No AB 2022/08/30 ZYDUS PHARMS
216044 002 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 75MG BASE Prescription No No AB 2022/11/28 UNIQUE
214691 002 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 75MG BASE Prescription No No AB 2023/04/12 AJANTA PHARMA LTD
活性成分:VENLAFAXINE HYDROCHLORIDE 剂型/给药途径:TABLET, 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
022104 003 NDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 150MG BASE Prescription Yes Yes AB 2008/05/20 OSMOTICA PHARM US
091272 003 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 150MG BASE Discontinued No No AB 2010/08/18 SUN PHARM
205468 002 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 150MG BASE Prescription No No AB 2017/03/24 NOSTRUM LABS INC
211323 002 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 150MG BASE Prescription No No AB 2019/08/29 CADILA PHARMS LTD
209193 001 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 150MG BASE Prescription No No AB 2019/10/31 DEXCEL
214419 003 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 150MG BASE Prescription No No AB 2020/10/21 ASCENT PHARMS INC
214127 003 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 150MG BASE Prescription No No AB 2021/06/10 ALKEM LABS LTD
214609 001 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 150MG BASE Prescription No No AB 2021/06/30 APPCO
214423 002 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 150MG BASE Discontinued No No AB 2022/01/04 SWISS PHARM
215622 003 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 150MG BASE Prescription No No AB 2022/08/30 ZYDUS PHARMS
216044 003 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 150MG BASE Prescription No No AB 2022/11/28 UNIQUE
214691 003 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 150MG BASE Prescription No No AB 2023/04/12 AJANTA PHARMA LTD
活性成分:VENLAFAXINE HYDROCHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:EQ 225MG 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
022104 004 NDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 225MG BASE Prescription Yes No AB 2008/05/20 OSMOTICA PHARM US
205468 003 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 225MG BASE Prescription No No AB 2017/03/24 NOSTRUM LABS INC
091272 004 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 225MG BASE Discontinued No No AB 2019/01/08 SUN PHARM
211323 003 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 225MG BASE Prescription No No AB 2019/08/29 CADILA PHARMS LTD
209193 002 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 225MG BASE Prescription No No AB 2019/10/31 DEXCEL
214419 004 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 225MG BASE Prescription No No AB 2020/10/21 ASCENT PHARMS INC
214127 004 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 225MG BASE Prescription No No AB 2021/06/10 ALKEM LABS LTD
214609 002 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 225MG BASE Prescription No No AB 2021/06/30 APPCO
215622 004 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 225MG BASE Prescription No No AB 2022/08/30 ZYDUS PHARMS
216044 004 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 225MG BASE Prescription No No AB 2022/11/28 UNIQUE
214691 004 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 225MG BASE Prescription No No AB 2023/04/12 AJANTA PHARMA LTD
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