药品注册申请号:022030
申请类型:NDA (新药申请)
申请人:PFIZER
申请人全名:PFIZER 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 TOVIAZ FESOTERODINE FUMARATE TABLET, EXTENDED RELEASE;ORAL 4MG Yes No AB 2008/10/31 2008/10/31 Prescription
002 TOVIAZ FESOTERODINE FUMARATE TABLET, EXTENDED RELEASE;ORAL 8MG Yes Yes AB 2008/10/31 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
2024/02/28 SUPPL-23(补充) Approval Labeling STANDARD
2024/02/28 SUPPL-22(补充) Approval Labeling STANDARD
2021/06/17 SUPPL-19(补充) Approval Efficacy PRIORITY
2017/11/12 SUPPL-14(补充) Approval Labeling STANDARD
2017/01/26 SUPPL-12(补充) Approval Manufacturing (CMC) STANDARD
2014/08/13 SUPPL-10(补充) Approval Manufacturing (CMC) STANDARD
2013/01/23 SUPPL-11(补充) Approval Manufacturing (CMC) STANDARD
2012/08/01 SUPPL-9(补充) Approval Labeling STANDARD
2011/12/30 SUPPL-8(补充) Approval Labeling STANDARD
2011/11/01 SUPPL-6(补充) Approval Labeling STANDARD
2011/02/10 SUPPL-7(补充) Approval Labeling STANDARD
2010/04/02 SUPPL-4(补充) Approval Labeling STANDARD
2008/10/31 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 7807715 2027/06/07 Y U-913 PDF格式
7807715*PED 2027/12/07 PDF格式
8088398 2027/06/07 Y U-913 PDF格式
8088398*PED 2027/12/07 PDF格式
8501723 2027/06/07 Y 2013/08/20 PDF格式
8501723*PED 2027/12/07 PDF格式
002 7807715 2027/06/07 Y U-913 PDF格式
7807715*PED 2027/12/07 PDF格式
8088398 2027/06/07 Y U-913 PDF格式
8088398*PED 2027/12/07 PDF格式
8501723 2027/06/07 Y 2013/08/20 PDF格式
8501723*PED 2027/12/07 PDF格式
001 6858650 2019/05/11 Y U-913 PDF格式**本条是由Drugfuture回溯的历史信息**
6858650 2022/07/03 Y U-913 PDF格式**本条是由Drugfuture回溯的历史信息**
6858650*PED 2023/01/03 PDF格式**本条是由Drugfuture回溯的历史信息**
7384980 2019/05/11 Y Y U-913 PDF格式**本条是由Drugfuture回溯的历史信息**
7384980 2019/10/14 Y Y U-913 PDF格式**本条是由Drugfuture回溯的历史信息**
7855230 2019/05/11 U-913 PDF格式**本条是由Drugfuture回溯的历史信息**
7985772 2019/05/11 Y Y U-913 PDF格式**本条是由Drugfuture回溯的历史信息**
8338478 2019/05/11 Y Y U-913 PDF格式**本条是由Drugfuture回溯的历史信息**
002 6858650 2019/05/11 Y U-913 PDF格式**本条是由Drugfuture回溯的历史信息**
6858650 2022/07/03 Y U-913 PDF格式**本条是由Drugfuture回溯的历史信息**
6858650*PED 2023/01/03 PDF格式**本条是由Drugfuture回溯的历史信息**
7384980 2019/05/11 Y Y U-913 PDF格式**本条是由Drugfuture回溯的历史信息**
7384980 2019/10/14 Y Y U-913 PDF格式**本条是由Drugfuture回溯的历史信息**
7855230 2019/05/11 U-913 PDF格式**本条是由Drugfuture回溯的历史信息**
7985772 2019/05/11 Y Y U-913 PDF格式**本条是由Drugfuture回溯的历史信息**
8338478 2019/05/11 Y Y U-913 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 I-861 2024/06/17
PED 2024/12/17
002 I-861 2024/06/17
PED 2024/12/17
001 NCE 2013/10/31**本条是由Drugfuture回溯的历史信息**
002 NCE 2013/10/31**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:FESOTERODINE FUMARATE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:4MG 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
022030 001 NDA TOVIAZ FESOTERODINE FUMARATE TABLET, EXTENDED RELEASE;ORAL 4MG Prescription Yes No AB 2008/10/31 PFIZER
204827 001 ANDA FESOTERODINE FUMARATE FESOTERODINE FUMARATE TABLET, EXTENDED RELEASE;ORAL 4MG Prescription No No AB 2015/12/10 ALKEM LABS LTD
205007 001 ANDA FESOTERODINE FUMARATE FESOTERODINE FUMARATE TABLET, EXTENDED RELEASE;ORAL 4MG Prescription No No AB 2017/02/17 AUROBINDO PHARMA
204946 001 ANDA FESOTERODINE FUMARATE FESOTERODINE FUMARATE TABLET, EXTENDED RELEASE;ORAL 4MG Prescription No No AB 2017/10/03 ZYDUS PHARMS
204975 001 ANDA FESOTERODINE FUMARATE FESOTERODINE FUMARATE TABLET, EXTENDED RELEASE;ORAL 4MG Prescription No No AB 2019/08/13 DR REDDYS
204973 001 ANDA FESOTERODINE FUMARATE FESOTERODINE FUMARATE TABLET, EXTENDED RELEASE;ORAL 4MG Prescription No No AB 2023/01/04 ALEMBIC
204868 001 ANDA FESOTERODINE FUMARATE FESOTERODINE FUMARATE TABLET, EXTENDED RELEASE;ORAL 4MG Discontinued No No AB 2023/01/04 ACTAVIS LABS FL INC
204504 001 ANDA FESOTERODINE FUMARATE FESOTERODINE FUMARATE TABLET, EXTENDED RELEASE;ORAL 4MG Discontinued No No AB 2023/01/04 ANI PHARMS
205012 001 ANDA FESOTERODINE FUMARATE FESOTERODINE FUMARATE TABLET, EXTENDED RELEASE;ORAL 4MG Discontinued No No AB 2023/01/04 ACCORD HLTHCARE
205002 001 ANDA FESOTERODINE FUMARATE FESOTERODINE FUMARATE TABLET, EXTENDED RELEASE;ORAL 4MG Prescription No No AB 2023/01/04 AMNEAL PHARMS NY
204983 001 ANDA FESOTERODINE FUMARATE FESOTERODINE FUMARATE TABLET, EXTENDED RELEASE;ORAL 4MG Discontinued No No AB 2023/01/05 CHARTWELL RX
204792 001 ANDA FESOTERODINE FUMARATE FESOTERODINE FUMARATE TABLET, EXTENDED RELEASE;ORAL 4MG Prescription No No AB 2024/01/09 HETERO LABS LTD V
活性成分:FESOTERODINE FUMARATE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:8MG 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
022030 002 NDA TOVIAZ FESOTERODINE FUMARATE TABLET, EXTENDED RELEASE;ORAL 8MG Prescription Yes Yes AB 2008/10/31 PFIZER
204827 002 ANDA FESOTERODINE FUMARATE FESOTERODINE FUMARATE TABLET, EXTENDED RELEASE;ORAL 8MG Prescription No No AB 2015/12/10 ALKEM LABS LTD
205007 002 ANDA FESOTERODINE FUMARATE FESOTERODINE FUMARATE TABLET, EXTENDED RELEASE;ORAL 8MG Prescription No No AB 2017/02/17 AUROBINDO PHARMA
204946 002 ANDA FESOTERODINE FUMARATE FESOTERODINE FUMARATE TABLET, EXTENDED RELEASE;ORAL 8MG Prescription No No AB 2017/10/03 ZYDUS PHARMS
204975 002 ANDA FESOTERODINE FUMARATE FESOTERODINE FUMARATE TABLET, EXTENDED RELEASE;ORAL 8MG Prescription No No AB 2019/08/13 DR REDDYS
204973 002 ANDA FESOTERODINE FUMARATE FESOTERODINE FUMARATE TABLET, EXTENDED RELEASE;ORAL 8MG Prescription No No AB 2023/01/04 ALEMBIC
204868 002 ANDA FESOTERODINE FUMARATE FESOTERODINE FUMARATE TABLET, EXTENDED RELEASE;ORAL 8MG Discontinued No No AB 2023/01/04 ACTAVIS LABS FL INC
204504 002 ANDA FESOTERODINE FUMARATE FESOTERODINE FUMARATE TABLET, EXTENDED RELEASE;ORAL 8MG Discontinued No No AB 2023/01/04 ANI PHARMS
205012 002 ANDA FESOTERODINE FUMARATE FESOTERODINE FUMARATE TABLET, EXTENDED RELEASE;ORAL 8MG Discontinued No No AB 2023/01/04 ACCORD HLTHCARE
205002 002 ANDA FESOTERODINE FUMARATE FESOTERODINE FUMARATE TABLET, EXTENDED RELEASE;ORAL 8MG Prescription No No AB 2023/01/04 AMNEAL PHARMS NY
204983 002 ANDA FESOTERODINE FUMARATE FESOTERODINE FUMARATE TABLET, EXTENDED RELEASE;ORAL 8MG Discontinued No No AB 2023/01/05 CHARTWELL RX
204792 002 ANDA FESOTERODINE FUMARATE FESOTERODINE FUMARATE TABLET, EXTENDED RELEASE;ORAL 8MG Prescription No No AB 2024/01/09 HETERO LABS LTD V
更多信息
药品NDC数据与药品包装、标签说明书
©2006-2024 DrugFuture->U.S. FDA Drugs Database