药品名称 | INVOKAMET | 申请号 | 204353 | 产品号 | 002 | 活性成分 | CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE | 市场状态 | 处方药 | 剂型或给药途径 | TABLET;ORAL | 规格 | 50MG;1GM | 治疗等效代码 | | 参比药物 | 否 | 批准日期 | 2014/08/08 | 申请机构 | JANSSEN 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 | NC | 2017/08/08 | NCE | 2018/03/29 | I-735 | 2019/05/20 | 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 | 204353 | 020 | AP | Letter | 2016/08/18 | 下载 | 204353 | 020 | AP | Label | 2016/08/22 | 下载 | 204353 | 015 | AP | Label | 2016/05/23 | 下载 | 204353 | 015 | AP | Letter | 2016/05/24 | 下载 | 204353 | 012 | AP | Letter | 2015/12/08 | 下载 | 204353 | 012 | AP | Label | 2015/12/08 | 下载 | 204353 | 010 | AP | Label | 2016/03/30 | 下载 | 204353 | 010 | AP | Letter | 2016/03/30 | 下载 | 204353 | 006 | AP | Label | 2016/05/23 | 下载 | 204353 | 006 | AP | Letter | 2016/05/24 | 下载 | 204353 | 003 | AP | Label | 2015/09/11 | 下载 | 204353 | 003 | AP | Letter | 2015/09/14 | 下载 | 204353 | 002 | AP | Letter | 2015/03/04 | 下载 | 204353 | 002 | AP | Label | 2015/03/20 | 下载 | 204353 | 000 | AP | Letter | 2014/08/11 | 下载 | 204353 | 000 | AP | Label | 2014/08/12 | 下载 | 204353 | 000 | AP | Review | 2014/09/03 | 下载 | 204353 | 000 | AP | Summary Review | 2014/09/03 | 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 | 204353 | 020 | AP | 2016/08/17 | Labeling Revision | 204353 | 017 | AP | 2016/10/18 | Manufacturing Change or Addition | 204353 | 015 | AP | 2016/05/20 | Supplement | 204353 | 012 | AP | 2015/12/04 | Labeling Revision | 204353 | 011 | AP | 2016/04/14 | Manufacturing Change or Addition | 204353 | 010 | AP | 2016/03/28 | Labeling Revision | 204353 | 008 | AP | 2016/03/17 | Manufacturing Change or Addition | 204353 | 007 | AP | 2015/12/23 | Manufacturing Change or Addition | 204353 | 006 | AP | 2016/05/20 | Efficacy Supplement with Clinical Data to Support | 204353 | 004 | AP | 2015/06/08 | Manufacturing Change or Addition | 204353 | 003 | AP | 2015/09/10 | Efficacy Supplement with Clinical Data to Support | 204353 | 002 | AP | 2015/03/03 | Labeling Revision | 204353 | 000 | AP | 2014/08/08 | Approval |
|