| 药品名称 | XTANDI | | 申请号 | 203415 | 产品号 | 001 | | 活性成分 | ENZALUTAMIDE | 市场状态 | 处方药 | | 剂型或给药途径 | CAPSULE;ORAL | 规格 | 40MG | | 治疗等效代码 | | 参比药物 | 是 | | 批准日期 | 2012/08/31 | 申请机构 | ASTELLAS PHARMA US INC
| | 化学类型 | New molecular entity (NME) | 审评分类 | Priority 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 | 2017/08/31 | | I-693 | 2017/09/10 | | 历史市场独占权保护信息 | | 无 |
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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 | | 203415 | 009 | AP | Letter | 2016/10/21 | 下载 | | 203415 | 009 | AP | Label | 2016/10/21 | 下载 | | 203415 | 007 | AP | Label | 2015/10/08 | 下载 | | 203415 | 007 | AP | Letter | 2015/10/09 | 下载 | | 203415 | 006 | AP | Letter | 2015/08/10 | 下载 | | 203415 | 006 | AP | Label | 2015/09/21 | 下载 | | 203415 | 005 | AP | Letter | 2015/07/22 | 下载 | | 203415 | 005 | AP | Label | 2015/07/22 | 下载 | | 203415 | 003 | AP | Label | 2014/09/10 | 下载 | | 203415 | 003 | AP | Letter | 2014/09/16 | 下载 | | 203415 | 001 | AP | Label | 2013/03/26 | 下载 | | 203415 | 000 | AP | Label | 2012/08/31 | 下载 | | 203415 | 000 | AP | Letter | 2012/09/05 | 下载 | | 203415 | 000 | AP | Review | 2012/09/12 | 下载 | | 203415 | 000 | AP | Summary Review | 2012/09/12 | 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 | | 203415 | 010 | AP | 2016/07/14 | Manufacturing Change or Addition | | 203415 | 009 | AP | 2016/10/20 | Efficacy Supplement with Clinical Data to Support | | 203415 | 008 | AP | 2015/11/06 | Manufacturing Change or Addition | | 203415 | 007 | AP | 2015/10/01 | Labeling Revision | | 203415 | 006 | AP | 2015/08/05 | Labeling Revision | | 203415 | 005 | AP | 2015/07/21 | Efficacy Supplement with Clinical Data to Support | | 203415 | 003 | AP | 2014/09/10 | Efficacy Supplement with Clinical Data to Support | | 203415 | 002 | AP | 2014/05/23 | Manufacturing Change or Addition | | 203415 | 001 | AP | 2013/03/19 | Manufacturing Change or Addition | | 203415 | 000 | AP | 2012/08/31 | Approval |
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