药品注册申请号:020771
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 TOLTERODINE TARTRATE TABLET;ORAL 1MG Yes No AB 1998/03/25 1998/03/25 Prescription
002 DETROL TOLTERODINE TARTRATE TABLET;ORAL 2MG Yes Yes AB 1998/03/25 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
2014/07/28 SUPPL 29 Approval Manufacturing (CMC) STANDARD
2012/08/01 SUPPL 28 Approval Labeling STANDARD
2011/09/20 SUPPL 24 Approval Labeling STANDARD
2009/04/08 SUPPL 22 Approval Labeling STANDARD
2008/09/11 SUPPL 19 Approval Labeling STANDARD
2007/03/16 SUPPL 17 Approval Labeling STANDARD
2006/03/24 SUPPL 14 Approval Labeling STANDARD
2005/10/17 SUPPL 13 Approval Labeling STANDARD
2004/01/05 SUPPL 11 Approval Labeling STANDARD
2003/07/21 SUPPL 10 Approval Labeling STANDARD
2001/07/20 SUPPL 9 Approval Manufacturing (CMC) STANDARD
2001/04/06 SUPPL 4 Approval Efficacy STANDARD
2000/11/09 SUPPL 5 Approval Manufacturing (CMC) STANDARD
2000/10/24 SUPPL 6 Approval Labeling STANDARD
2000/05/26 SUPPL 3 Approval Manufacturing (CMC) STANDARD
1998/08/31 SUPPL 1 Approval Manufacturing (CMC) STANDARD
1998/03/25 ORIG 1 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 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**
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**
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
与本品治疗等效的药品
活性成分:TOLTERODINE TARTRATE 剂型/给药途径:TABLET;ORAL 规格:1MG 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
020771 001 NDA DETROL TOLTERODINE TARTRATE TABLET;ORAL 1MG Prescription Yes No AB 1998/03/25 PHARMACIA AND UPJOHN
202641 001 ANDA TOLTERODINE TARTRATE TOLTERODINE TARTRATE TABLET;ORAL 1MG Prescription No No AB 2012/11/27 MYLAN PHARMS INC
077006 001 ANDA TOLTERODINE TARTRATE TOLTERODINE TARTRATE TABLET;ORAL 1MG Prescription No No AB 2015/02/23 IVAX SUB TEVA PHARMS
203409 001 ANDA TOLTERODINE TARTRATE TOLTERODINE TARTRATE TABLET;ORAL 1MG Prescription No No AB 2015/08/31 MACLEODS PHARMS LTD
活性成分:TOLTERODINE TARTRATE 剂型/给药途径:TABLET;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
020771 002 NDA DETROL TOLTERODINE TARTRATE TABLET;ORAL 2MG Prescription Yes Yes AB 1998/03/25 PHARMACIA AND UPJOHN
202641 002 ANDA TOLTERODINE TARTRATE TOLTERODINE TARTRATE TABLET;ORAL 2MG Prescription No No AB 2012/11/27 MYLAN PHARMS INC
077006 002 ANDA TOLTERODINE TARTRATE TOLTERODINE TARTRATE TABLET;ORAL 2MG Prescription No No AB 2015/02/23 IVAX SUB TEVA PHARMS
203409 002 ANDA TOLTERODINE TARTRATE TOLTERODINE TARTRATE TABLET;ORAL 2MG Prescription No No AB 2015/08/31 MACLEODS PHARMS LTD
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