药品注册申请号:021228
申请类型:NDA (新药申请)
申请人:PHARMACIA AND UPJOHN
申请人全名:PHARMACIA AND UPJOHN CO
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 DETROL LA TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE;ORAL 2MG Yes No AB 2000/12/22 2000/12/22 Prescription
002 DETROL LA TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE;ORAL 4MG Yes Yes AB 2000/12/22 Prescription
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2018/07/13 SUPPL 23 Approval Labeling STANDARD
2014/07/28 SUPPL 22 Approval Manufacturing (CMC) STANDARD
2012/08/01 SUPPL 21 Approval Labeling STANDARD
2011/09/20 SUPPL 16 Approval Labeling STANDARD
2010/01/05 SUPPL 15 Approval Labeling STANDARD
2008/09/11 SUPPL 12 Approval Labeling STANDARD
2007/03/16 SUPPL 10 Approval Labeling STANDARD
2005/10/20 SUPPL 7 Approval Efficacy UNKNOWN
2005/07/14 SUPPL 8 Approval Labeling STANDARD
2004/04/14 SUPPL 6 Approval Efficacy PRIORITY
2004/01/15 SUPPL 5 Approval Labeling STANDARD
2003/07/21 SUPPL 4 Approval Labeling STANDARD
2001/12/17 SUPPL 3 Approval Manufacturing (CMC) STANDARD
2001/09/21 SUPPL 2 Approval Labeling STANDARD
2001/04/27 SUPPL 1 Approval Labeling STANDARD
2000/12/22 ORIG 1 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 6630162 2019/11/11 Y U-544 PDF格式
6630162*PED 2020/05/11 PDF格式
6770295 2019/08/26 Y U-544 PDF格式
6770295*PED 2020/02/26 PDF格式
6911217 2019/11/11 Y U-544 2013/04/30 PDF格式
6911217*PED 2020/05/11 PDF格式
002 6630162 2019/11/11 Y U-544 PDF格式
6630162*PED 2020/05/11 PDF格式
6770295 2019/08/26 Y U-544 PDF格式
6770295*PED 2020/02/26 PDF格式
6911217 2019/11/11 Y U-544 PDF格式
6911217*PED 2020/05/11 PDF格式
001 5382600 2012/03/25 PDF格式**本条是由Drugfuture回溯的历史信息**
5382600*PED 2012/09/25 PDF格式**本条是由Drugfuture回溯的历史信息**
6911217*PED 2020/02/26 Y U-544 PDF格式**本条是由Drugfuture回溯的历史信息**
002 5382600 2012/03/25 PDF格式**本条是由Drugfuture回溯的历史信息**
5382600*PED 2012/09/25 PDF格式**本条是由Drugfuture回溯的历史信息**
6911217*PED 2020/02/26 Y U-544 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 M-46 2008/10/21**本条是由Drugfuture回溯的历史信息**
002 M-46 2008/10/21**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:TOLTERODINE TARTRATE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:2MG 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
021228 001 NDA DETROL LA TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE;ORAL 2MG Prescription Yes No AB 2000/12/22 PHARMACIA AND UPJOHN
201486 001 ANDA TOLTERODINE TARTRATE TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE;ORAL 2MG Prescription No No AB 2013/10/31 MYLAN
203016 001 ANDA TOLTERODINE TARTRATE TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE;ORAL 2MG Prescription No No AB 2015/08/11 TORRENT
079141 001 ANDA TOLTERODINE TARTRATE TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE;ORAL 2MG Prescription No No AB 2016/11/22 TEVA PHARMS USA
206419 001 ANDA TOLTERODINE TARTRATE TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE;ORAL 2MG Prescription No No AB 2017/12/12 HETERO LABS LTD III
204562 001 ANDA TOLTERODINE TARTRATE TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE;ORAL 2MG Prescription No No AB 2019/08/19 INVENTIA HLTHCARE
活性成分:TOLTERODINE TARTRATE 剂型/给药途径:CAPSULE, 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
021228 002 NDA DETROL LA TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE;ORAL 4MG Prescription Yes Yes AB 2000/12/22 PHARMACIA AND UPJOHN
201486 002 ANDA TOLTERODINE TARTRATE TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE;ORAL 4MG Prescription No No AB 2013/10/31 MYLAN
203016 002 ANDA TOLTERODINE TARTRATE TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE;ORAL 4MG Prescription No No AB 2015/08/11 TORRENT
079141 002 ANDA TOLTERODINE TARTRATE TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE;ORAL 4MG Prescription No No AB 2016/11/22 TEVA PHARMS USA
206419 002 ANDA TOLTERODINE TARTRATE TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE;ORAL 4MG Prescription No No AB 2017/12/12 HETERO LABS LTD III
204562 002 ANDA TOLTERODINE TARTRATE TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE;ORAL 4MG Prescription No No AB 2019/08/19 INVENTIA HLTHCARE
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