药品名称 | JENTADUETO | 申请号 | 201281 | 产品号 | 003 | 活性成分 | LINAGLIPTIN; METFORMIN HYDROCHLORIDE | 市场状态 | 处方药 | 剂型或给药途径 | TABLET;ORAL | 规格 | 2.5MG;1GM | 治疗等效代码 | | 参比药物 | 是 | 批准日期 | 2012/01/30 | 申请机构 | BOEHRINGER INGELHEIM PHARMACEUTICALS INC
| 化学类型 | New combination | 审评分类 | Standard review drug |
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与本品相关的市场独占权保护信息 | 独占权代码 | 失效日期 | NCE | 2016/05/02 | M-146 | 2017/07/30 | 历史市场独占权保护信息 | NC | 2015/01/30 |
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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 | 201281 | 010 | AP | Letter | 2015/09/01 | 下载 | 201281 | 010 | AP | Label | 2015/09/03 | 下载 | 201281 | 008 | AP | Letter | 2015/07/29 | 下载 | 201281 | 008 | AP | Label | 2015/07/30 | 下载 | 201281 | 007 | AP | Letter | 2014/05/23 | 下载 | 201281 | 007 | AP | Label | 2014/05/28 | 下载 | 201281 | 006 | AP | Letter | 2014/07/31 | 下载 | 201281 | 006 | AP | Label | 2014/07/31 | 下载 | 201281 | 004 | AP | Label | 2013/09/09 | 下载 | 201281 | 004 | AP | Letter | 2013/09/10 | 下载 | 201281 | 003 | AP | Letter | 2013/06/20 | 下载 | 201281 | 003 | AP | Label | 2013/06/25 | 下载 | 201281 | 002 | AP | Letter | 2012/09/27 | 下载 | 201281 | 000 | AP | Medication Guide | 2013/06/28 | 下载 | 201281 | 000 | AP | Review | 2013/07/26 | 下载 | 201281 | 000 | AP | Summary Review | 2013/07/26 | 下载 | 201281 | 000 | AP | Label | 2012/02/01 | 下载 | 201281 | 000 | AP | Letter | 2012/02/02 | 下载 |
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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 | 201281 | 015 | AP | 2016/10/07 | Manufacturing Change or Addition | 201281 | 012 | AP | 2016/04/29 | Manufacturing Change or Addition | 201281 | 011 | AP | 2016/02/11 | Manufacturing Change or Addition | 201281 | 010 | AP | 2015/08/28 | Labeling Revision | 201281 | 009 | AP | 2015/09/18 | Manufacturing Change or Addition | 201281 | 008 | AP | 2015/07/28 | Labeling Revision | 201281 | 007 | AP | 2014/05/22 | Labeling Revision | 201281 | 006 | AP | 2014/07/30 | Efficacy Supplement with Clinical Data to Support | 201281 | 005 | AP | 2013/12/18 | Manufacturing Change or Addition | 201281 | 004 | AP | 2013/09/05 | Efficacy Supplement with Clinical Data to Support | 201281 | 003 | AP | 2013/06/18 | Labeling Revision | 201281 | 002 | AP | 2012/09/25 | Labeling Revision | 201281 | 000 | AP | 2012/01/30 | Approval |
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