| 药品名称 | ONGLYZA | | 申请号 | 022350 | 产品号 | 002 | | 活性成分 | SAXAGLIPTIN HYDROCHLORIDE | 市场状态 | 处方药 | | 剂型或给药途径 | TABLET;ORAL | 规格 | EQ 5MG BASE | | 治疗等效代码 | | 参比药物 | 是 | | 批准日期 | 2009/07/31 | 申请机构 | ASTRAZENECA AB
| | 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-134 | 2016/05/24 | | M-175 | 2019/04/05 | | 历史市场独占权保护信息 | | M-108 | 2014/12/16 | | NCE | 2014/07/31 |
|
| 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 | | 022350 | 016 | AP | Letter | 2015/09/01 | 下载 | | 022350 | 016 | AP | Label | 2015/09/04 | 下载 | | 022350 | 014 | AP | Letter | 2016/04/07 | 下载 | | 022350 | 014 | AP | Label | 2016/04/07 | 下载 | | 022350 | 011 | AP | Letter | 2013/05/29 | 下载 | | 022350 | 011 | AP | Label | 2013/06/04 | 下载 | | 022350 | 009 | AP | Letter | 2012/03/15 | 下载 | | 022350 | 007 | AP | Label | 2011/11/16 | 下载 | | 022350 | 007 | AP | Medication Guide | 2011/11/16 | 下载 | | 022350 | 007 | AP | Letter | 2011/11/17 | 下载 | | 022350 | 004 | AP | Letter | 2011/12/22 | 下载 | | 022350 | 004 | AP | Medication Guide | 2011/12/23 | 下载 | | 022350 | 004 | AP | Label | 2011/12/23 | 下载 | | 022350 | 002 | AP | Label | 2011/02/24 | 下载 | | 022350 | 002 | AP | Letter | 2011/02/24 | 下载 | | 022350 | 001 | AP | Label | 2011/02/24 | 下载 | | 022350 | 001 | AP | Letter | 2011/02/24 | 下载 | | 022350 | 000 | AP | Letter | 2009/08/06 | 下载 | | 022350 | 000 | AP | Label | 2009/08/14 | 下载 | | 022350 | 000 | AP | Review | 2009/09/29 | 下载 | | 022350 | 000 | AP | Summary Review | 2009/09/29 | 下载 | | 022350 | 000 | AP | Medication Guide | 2013/06/12 | 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 | | 022350 | 017 | AP | 2015/11/25 | Manufacturing Change or Addition | | 022350 | 016 | AP | 2015/08/28 | Labeling Revision | | 022350 | 014 | AP | 2016/04/05 | Efficacy Supplement with Clinical Data to Support | | 022350 | 013 | AP | 2014/01/23 | Manufacturing Change or Addition | | 022350 | 011 | AP | 2013/05/24 | Efficacy Supplement with Clinical Data to Support | | 022350 | 009 | AP | 2012/03/13 | Labeling Revision | | 022350 | 007 | AP | 2011/11/15 | Labeling Revision | | 022350 | 004 | AP | 2011/12/16 | Efficacy Supplement with Clinical Data to Support | | 022350 | 002 | AP | 2011/02/18 | Efficacy Supplement with Clinical Data to Support | | 022350 | 001 | AP | 2011/02/18 | Efficacy Supplement with Clinical Data to Support | | 022350 | 000 | AP | 2009/07/31 | Approval |
|