| 药品名称 | TRADJENTA | | 申请号 | 201280 | 产品号 | 001 | | 活性成分 | LINAGLIPTIN | 市场状态 | 处方药 | | 剂型或给药途径 | TABLET;ORAL | 规格 | 5MG | | 治疗等效代码 | | 参比药物 | 是 | | 批准日期 | 2011/05/02 | 申请机构 | BOEHRINGER INGELHEIM PHARMACEUTICALS INC
| | 化学类型 | New molecular entity (NME) | 审评分类 | Standard review drug |
|
|
|
| 与本品相关的市场独占权保护信息 | | 独占权代码 | 失效日期 | | M-118 | 2015/08/13 | | M-121 | 2015/08/13 | | NCE | 2016/05/02 | | 历史市场独占权保护信息 | | 无 |
|
| 与药品注册相关的信息 | | 申请号 | 修订号 | 审批结论 | 公开文档类型 | 文档创建时间 | 获取文档 | | 201280 | 012 | AP | Letter | 2015/09/01 | 下载 | | 201280 | 012 | AP | Label | 2015/09/04 | 下载 | | 201280 | 011 | AP | Letter | 2015/07/29 | 下载 | | 201280 | 011 | AP | Label | 2015/07/30 | 下载 | | 201280 | 009 | AP | Letter | 2014/05/23 | 下载 | | 201280 | 009 | AP | Label | 2014/05/28 | 下载 | | 201280 | 006 | AP | Letter | 2013/06/20 | 下载 | | 201280 | 006 | AP | Label | 2013/06/25 | 下载 | | 201280 | 005 | AP | Label | 2012/10/01 | 下载 | | 201280 | 005 | AP | Letter | 2012/10/02 | 下载 | | 201280 | 004 | AP | Label | 2012/08/15 | 下载 | | 201280 | 004 | AP | Letter | 2012/08/15 | 下载 | | 201280 | 003 | AP | Label | 2012/08/15 | 下载 | | 201280 | 003 | AP | Letter | 2012/08/15 | 下载 | | 201280 | 002 | AP | Review | 2014/07/07 | 下载 | | 201280 | 002 | AP | Label | 2012/05/23 | 下载 | | 201280 | 002 | AP | Letter | 2012/05/24 | 下载 | | 201280 | 000 | AP | Label | 2011/05/06 | 下载 | | 201280 | 000 | AP | Letter | 2011/05/06 | 下载 | | 201280 | 000 | AP | Review | 2011/06/07 | 下载 | | 201280 | 000 | AP | Summary Review | 2011/06/07 | 下载 | | 201280 | 000 | AP | Medication Guide | 2013/06/28 | 下载 |
|
| 药品注册审批历史信息 | | 申请号 | 修订号 | 审批结论 | 审批日期 | 审批内容 | | 201280 | 012 | AP | 2015/08/28 | Labeling Revision | | 201280 | 011 | AP | 2015/07/28 | Labeling Revision | | 201280 | 010 | AP | 2015/07/20 | Manufacturing Change or Addition | | 201280 | 009 | AP | 2014/05/22 | Labeling Revision | | 201280 | 006 | AP | 2013/06/18 | Labeling Revision | | 201280 | 005 | AP | 2012/09/28 | Efficacy Supplement with Clinical Data to Support | | 201280 | 004 | AP | 2012/08/13 | Efficacy Supplement with Clinical Data to Support | | 201280 | 003 | AP | 2012/08/13 | Efficacy Supplement with Clinical Data to Support | | 201280 | 002 | AP | 2012/05/22 | Efficacy Supplement with Clinical Data to Support | | 201280 | 000 | AP | 2011/05/02 | Approval |
|