药品注册申请号：021518
申请类型：NDA (新药申请)
申请人：ASTELLAS
申请人全名：ASTELLAS PHARMA US 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 VESICARE SOLIFENACIN SUCCINATE TABLET;ORAL 5MG Yes No AB 2004/11/19 2004/11/19 Prescription
002 VESICARE SOLIFENACIN SUCCINATE TABLET;ORAL 10MG Yes Yes AB 2004/11/19 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
2020/05/26 SUPPL-17（补充） Approval Labeling STANDARD
2019/04/30 SUPPL-18（补充） Approval Labeling STANDARD
2013/10/09 SUPPL-16（补充） Approval Labeling STANDARD
2013/03/29 SUPPL-15（补充） Approval Labeling STANDARD
2012/08/03 SUPPL-14（补充） Approval Labeling STANDARD
2012/07/13 SUPPL-13（补充） Approval Labeling STANDARD
2012/06/07 SUPPL-11（补充） Approval Labeling STANDARD
2012/01/17 SUPPL-12（补充） Approval Labeling STANDARD
2011/03/10 SUPPL-10（补充） Approval Labeling UNKNOWN
2010/07/12 SUPPL-8（补充） Approval Labeling STANDARD
2008/11/18 SUPPL-7（补充） Approval Labeling STANDARD
2008/10/29 SUPPL-6（补充） Approval Labeling STANDARD
2008/02/08 SUPPL-4（补充） Approval Labeling STANDARD
2007/07/12 SUPPL-3（补充） Approval Labeling STANDARD
2007/04/24 SUPPL-2（补充） Approval Manufacturing (CMC) N/A
2004/11/19 ORIG-1（原始申请） Approval Type 1 - New Molecular Entity 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 6017927 2015/12/27 Y Y PDF格式**本条是由Drugfuture回溯的历史信息**
6017927 2018/11/19 Y Y PDF格式**本条是由Drugfuture回溯的历史信息**
6017927*PED 2019/05/19 PDF格式**本条是由Drugfuture回溯的历史信息**
002 6017927 2015/12/27 Y Y PDF格式**本条是由Drugfuture回溯的历史信息**
6017927 2018/11/19 Y Y PDF格式**本条是由Drugfuture回溯的历史信息**
6017927*PED 2019/05/19 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
001 NCE 2009/11/19**本条是由Drugfuture回溯的历史信息**
002 NCE 2009/11/19**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:SOLIFENACIN SUCCINATE 剂型/给药途径:TABLET;ORAL 规格:5MG 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
021518 001 NDA VESICARE SOLIFENACIN SUCCINATE TABLET;ORAL 5MG Prescription Yes No AB 2004/11/19 ASTELLAS
091464 001 ANDA SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE TABLET;ORAL 5MG Prescription No No AB 2014/04/02 TEVA PHARMS USA
202551 001 ANDA SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE TABLET;ORAL 5MG Prescription No No AB 2019/05/20 WATSON LABS INC
211657 001 ANDA SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE TABLET;ORAL 5MG Prescription No No AB 2019/05/20 SCIEGEN PHARMS INC
209239 001 ANDA SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE TABLET;ORAL 5MG Prescription No No AB 2019/05/20 GLENMARK PHARMS
209333 001 ANDA SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE TABLET;ORAL 5MG Prescription No No AB 2019/05/20 QILU
209839 001 ANDA SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE TABLET;ORAL 5MG Discontinued No No AB 2019/05/20 CIPLA
210224 001 ANDA SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE TABLET;ORAL 5MG Prescription No No AB 2019/05/20 ALKEM LABS LTD
210281 001 ANDA SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE TABLET;ORAL 5MG Prescription No No AB 2019/05/20 AUSTARPHARMA
210582 001 ANDA SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE TABLET;ORAL 5MG Prescription No No AB 2019/05/20 CHARTWELL RX
210688 001 ANDA SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE TABLET;ORAL 5MG Prescription No No AB 2019/05/20 MSN
205575 001 ANDA SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE TABLET;ORAL 5MG Prescription No No AB 2019/05/20 ALEMBIC
211701 001 ANDA SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE TABLET;ORAL 5MG Prescription No No AB 2019/08/27 UNICHEM
212214 001 ANDA SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE TABLET;ORAL 5MG Prescription No No AB 2019/09/26 STRIDES PHARMA
211423 001 ANDA SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE TABLET;ORAL 5MG Prescription No No AB 2019/12/11 RISING
207477 001 ANDA SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE TABLET;ORAL 5MG Discontinued No No AB 2022/01/04 ACCORD HLTHCARE
215761 001 ANDA SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE TABLET;ORAL 5MG Prescription No No AB 2022/06/15 ANNORA PHARMA
206817 001 ANDA SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE TABLET;ORAL 5MG Prescription No No AB 2022/12/27 AUROBINDO PHARMA
211622 001 ANDA SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE TABLET;ORAL 5MG Discontinued No No AB 2023/06/06 LANNETT CO INC
204374 001 ANDA SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE TABLET;ORAL 5MG Prescription No No AB 2024/02/20 MACLEODS PHARMS LTD
活性成分:SOLIFENACIN SUCCINATE 剂型/给药途径:TABLET;ORAL 规格:10MG 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
021518 002 NDA VESICARE SOLIFENACIN SUCCINATE TABLET;ORAL 10MG Prescription Yes Yes AB 2004/11/19 ASTELLAS
091464 002 ANDA SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE TABLET;ORAL 10MG Prescription No No AB 2014/04/02 TEVA PHARMS USA
202551 002 ANDA SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE TABLET;ORAL 10MG Prescription No No AB 2019/05/20 WATSON LABS INC
211657 002 ANDA SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE TABLET;ORAL 10MG Prescription No No AB 2019/05/20 SCIEGEN PHARMS INC
209239 002 ANDA SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE TABLET;ORAL 10MG Prescription No No AB 2019/05/20 GLENMARK PHARMS
209333 002 ANDA SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE TABLET;ORAL 10MG Prescription No No AB 2019/05/20 QILU
209839 002 ANDA SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE TABLET;ORAL 10MG Discontinued No No AB 2019/05/20 CIPLA
210224 002 ANDA SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE TABLET;ORAL 10MG Prescription No No AB 2019/05/20 ALKEM LABS LTD
210281 002 ANDA SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE TABLET;ORAL 10MG Prescription No No AB 2019/05/20 AUSTARPHARMA
210582 002 ANDA SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE TABLET;ORAL 10MG Prescription No No AB 2019/05/20 CHARTWELL RX
210688 002 ANDA SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE TABLET;ORAL 10MG Prescription No No AB 2019/05/20 MSN
205575 002 ANDA SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE TABLET;ORAL 10MG Prescription No No AB 2019/05/20 ALEMBIC
211701 002 ANDA SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE TABLET;ORAL 10MG Prescription No No AB 2019/08/27 UNICHEM
212214 002 ANDA SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE TABLET;ORAL 10MG Prescription No No AB 2019/09/26 STRIDES PHARMA
211423 002 ANDA SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE TABLET;ORAL 10MG Prescription No No AB 2019/12/11 RISING
207477 002 ANDA SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE TABLET;ORAL 10MG Discontinued No No AB 2022/01/04 ACCORD HLTHCARE
215761 002 ANDA SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE TABLET;ORAL 10MG Prescription No No AB 2022/06/15 ANNORA PHARMA
206817 002 ANDA SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE TABLET;ORAL 10MG Prescription No No AB 2022/12/27 AUROBINDO PHARMA
211622 002 ANDA SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE TABLET;ORAL 10MG Discontinued No No AB 2023/06/06 LANNETT CO INC
204374 002 ANDA SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE TABLET;ORAL 10MG Prescription No No AB 2024/02/20 MACLEODS PHARMS LTD
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
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