| 药品名称 | ELIQUIS | | 申请号 | 202155 | 产品号 | 002 | | 活性成分 | APIXABAN | 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 | 2012/12/28 | 申请机构 | BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
| | 化学类型 | New molecular entity (NME) | 审评分类 | Priority 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 | | NCE | 2017/12/28 | | I-690 | 2017/08/21 | | I-661 | 2017/08/21 | | I-691 | 2017/08/21 | | 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 | | 202155 | 014 | AP | Letter | 2016/03/04 | 下载 | | 202155 | 013 | AP | Review | 2016/08/05 | 下载 | | 202155 | 012 | AP | Label | 2016/07/21 | 下载 | | 202155 | 012 | AP | Letter | 2016/07/22 | 下载 | | 202155 | 011 | AP | Label | 2015/09/11 | 下载 | | 202155 | 011 | AP | Letter | 2015/09/14 | 下载 | | 202155 | 010 | AP | Letter | 2015/06/18 | 下载 | | 202155 | 010 | AP | Label | 2015/06/19 | 下载 | | 202155 | 009 | AP | Label | 2014/08/13 | 下载 | | 202155 | 009 | AP | Letter | 2014/08/14 | 下载 | | 202155 | 006 | AP | Label | 2014/09/09 | 下载 | | 202155 | 006 | AP | Letter | 2014/09/10 | 下载 | | 202155 | 004 | AP | Letter | 2013/11/06 | 下载 | | 202155 | 004 | AP | Label | 2013/11/19 | 下载 | | 202155 | 003 | AP | Letter | 2014/03/14 | 下载 | | 202155 | 003 | AP | Label | 2014/03/19 | 下载 | | 202155 | 002 | AP | Review | 2014/03/21 | 下载 | | 202155 | 002 | AP | Label | 2014/01/31 | 下载 | | 202155 | 002 | AP | Letter | 2014/02/04 | 下载 | | 202155 | 000 | AP | Label | 2012/12/31 | 下载 | | 202155 | 000 | AP | Letter | 2013/01/02 | 下载 | | 202155 | 000 | AP | Medication Guide | 2013/01/03 | 下载 | | 202155 | 000 | AP | Review | 2013/02/13 | 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 | | 202155 | 014 | AP | 2016/03/02 | Supplement | | 202155 | 013 | AP | 2016/05/03 | Manufacturing Change or Addition | | 202155 | 012 | AP | 2016/07/20 | Labeling Revision | | 202155 | 011 | AP | 2015/09/10 | Labeling Revision | | 202155 | 010 | AP | 2015/06/16 | Labeling Revision | | 202155 | 009 | AP | 2014/08/12 | Labeling Revision | | 202155 | 008 | AP | 2015/05/01 | Manufacturing Change or Addition | | 202155 | 007 | AP | 2014/04/30 | Manufacturing Change or Addition | | 202155 | 006 | AP | 2014/08/21 | Efficacy Supplement with Clinical Data to Support | | 202155 | 005 | AP | 2015/03/09 | Manufacturing Change or Addition | | 202155 | 004 | AP | 2013/10/31 | Labeling Revision | | 202155 | 003 | AP | 2014/03/13 | Efficacy Supplement with Clinical Data to Support | | 202155 | 002 | AP | 2014/01/30 | Labeling Revision | | 202155 | 001 | AP | 2013/07/16 | Manufacturing Change or Addition | | 202155 | 000 | AP | 2012/12/28 | Approval |
|