| 药品名称 | VICTRELIS | | 申请号 | 202258 | 产品号 | 001 | | 活性成分 | BOCEPREVIR | 市场状态 | 停止上市 | | 剂型或给药途径 | CAPSULE;ORAL | 规格 | 200MG | | 治疗等效代码 | | 参比药物 | 否 | | 批准日期 | 2011/05/13 | 申请机构 | MERCK SHARP AND DOHME CORP
| | 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 | | M-126 | 2016/02/27 | | NCE | 2016/05/13 | | NPP | 2016/02/13 | | 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 | | 202258 | 015 | AP | Letter | 2014/07/29 | 下载 | | 202258 | 015 | AP | Label | 2014/07/29 | 下载 | | 202258 | 014 | AP | Label | 2014/02/25 | 下载 | | 202258 | 014 | AP | Letter | 2014/02/26 | 下载 | | 202258 | 013 | AP | Label | 2014/02/10 | 下载 | | 202258 | 013 | AP | Letter | 2014/02/11 | 下载 | | 202258 | 012 | AP | Letter | 2014/01/21 | 下载 | | 202258 | 012 | AP | Label | 2014/01/22 | 下载 | | 202258 | 011 | AP | Label | 2014/04/10 | 下载 | | 202258 | 011 | AP | Letter | 2014/04/10 | 下载 | | 202258 | 009 | AP | Label | 2013/09/19 | 下载 | | 202258 | 009 | AP | Letter | 2013/09/19 | 下载 | | 202258 | 007 | AP | Label | 2013/02/20 | 下载 | | 202258 | 007 | AP | Letter | 2013/02/20 | 下载 | | 202258 | 006 | AP | Letter | 2012/12/26 | 下载 | | 202258 | 006 | AP | Label | 2012/12/28 | 下载 | | 202258 | 005 | AP | Letter | 2012/11/06 | 下载 | | 202258 | 005 | AP | Label | 2012/11/28 | 下载 | | 202258 | 004 | AP | Letter | 2013/03/01 | 下载 | | 202258 | 004 | AP | Label | 2013/03/01 | 下载 | | 202258 | 003 | AP | Label | 2013/02/14 | 下载 | | 202258 | 003 | AP | Letter | 2013/02/15 | 下载 | | 202258 | 002 | AP | Medication Guide | 2012/04/24 | 下载 | | 202258 | 002 | AP | Label | 2012/04/24 | 下载 | | 202258 | 002 | AP | Letter | 2012/04/24 | 下载 | | 202258 | 001 | AP | Label | 2012/07/30 | 下载 | | 202258 | 001 | AP | Letter | 2012/08/01 | 下载 | | 202258 | 000 | AP | Label | 2011/05/13 | 下载 | | 202258 | 000 | AP | FDA Press Release | 2011/05/13 | 下载 | | 202258 | 000 | AP | Letter | 2011/05/13 | 下载 | | 202258 | 000 | AP | Medication Guide | 2011/05/17 | 下载 | | 202258 | 000 | AP | Review | 2011/06/15 | 下载 | | 202258 | 000 | AP | Summary Review | 2011/06/15 | 下载 | | 202258 | 000 | AP | Other Important Information from FDA | 2012/02/13 | 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 | | 202258 | 015 | AP | 2014/07/28 | Labeling Revision | | 202258 | 014 | AP | 2014/02/24 | Labeling Revision | | 202258 | 013 | AP | 2014/02/07 | Labeling Revision | | 202258 | 012 | AP | 2014/01/17 | Labeling Revision | | 202258 | 011 | AP | 2014/04/09 | Efficacy Supplement with Clinical Data to Support | | 202258 | 009 | AP | 2013/09/18 | Labeling Revision | | 202258 | 008 | AP | 2013/07/22 | Manufacturing Change or Addition | | 202258 | 007 | AP | 2013/02/15 | Labeling Revision | | 202258 | 006 | AP | 2012/12/21 | Labeling Revision | | 202258 | 005 | AP | 2012/11/02 | Labeling Revision | | 202258 | 004 | AP | 2013/02/27 | Efficacy Supplement with Clinical Data to Support | | 202258 | 003 | AP | 2013/02/13 | Efficacy Supplement with Clinical Data to Support | | 202258 | 002 | AP | 2012/04/20 | Labeling Revision | | 202258 | 001 | AP | 2012/07/30 | Labeling Revision | | 202258 | 000 | AP | 2011/05/13 | Approval |
|