| 药品名称 | XELODA | | 申请号 | 020896 | 产品号 | 002 | | 活性成分 | CAPECITABINE | 市场状态 | 处方药 | | 剂型或给药途径 | TABLET;ORAL | 规格 | 500MG | | 治疗等效代码 | AB | 参比药物 | 是 | | 批准日期 | 1998/04/30 | 申请机构 | HOFFMANN LA ROCHE 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 | | M-131 | 2016/12/10 | | PED | 2017/06/10 | | 历史市场独占权保护信息 | | I-461 | 2008/06/15 |
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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 | | 020896 | 037 | AP | Letter | 2015/03/24 | 下载 | | 020896 | 037 | AP | Label | 2015/03/24 | 下载 | | 020896 | 036 | AP | Letter | 2015/03/03 | 下载 | | 020896 | 036 | AP | Label | 2015/03/05 | 下载 | | 020896 | 034 | AP | Letter | 2014/10/21 | 下载 | | 020896 | 034 | AP | Label | 2014/10/21 | 下载 | | 020896 | 032 | AP | Label | 2013/12/11 | 下载 | | 020896 | 032 | AP | Letter | 2013/12/16 | 下载 | | 020896 | 026 | AP | Label | 2011/02/09 | 下载 | | 020896 | 026 | AP | Letter | 2011/02/09 | 下载 | | 020896 | 016 | AP | Label | 2005/06/15 | 下载 | | 020896 | 016 | AP | Letter | 2005/06/16 | 下载 | | 020896 | 012 | AP | Label | 2003/03/26 | 下载 | | 020896 | 012 | AP | Letter | 2003/03/26 | 下载 | | 020896 | 011 | AP | Letter | 2001/09/07 | 下载 | | 020896 | 011 | AP | Label | 2001/09/07 | 下载 | | 020896 | 011 | AP | Review | 2001/09/07 | 下载 | | 020896 | 010 | AP | Letter | 2001/09/07 | 下载 | | 020896 | 010 | AP | Label | 2001/09/07 | 下载 | | 020896 | 010 | AP | Review | 2001/09/07 | 下载 | | 020896 | 009 | AP | Label | 2003/04/25 | 下载 | | 020896 | 009 | AP | Letter | 2001/04/30 | 下载 | | 020896 | 009 | AP | Review | 2001/04/30 | 下载 | | 020896 | 006 | AP | Letter | 2001/04/30 | 下载 | | 020896 | 006 | AP | Review | 2001/04/30 | 下载 | | 020896 | 000 | AP | Letter | 1998/04/30 | 下载 | | 020896 | 000 | AP | Review | 1998/04/30 | 下载 | | 020896 | 000 | AP | Label | 1998/04/30 | 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 | | 020896 | 038 | AP | 2015/12/22 | Manufacturing Change or Addition | | 020896 | 037 | AP | 2015/03/19 | Labeling Revision | | 020896 | 036 | AP | 2015/03/02 | Labeling Revision | | 020896 | 035 | AP | 2015/01/05 | Manufacturing Change or Addition | | 020896 | 034 | AP | 2014/10/16 | Labeling Revision | | 020896 | 033 | AP | 2014/07/22 | Manufacturing Change or Addition | | 020896 | 032 | AP | 2013/12/10 | Efficacy Supplement with Clinical Data to Support | | 020896 | 026 | AP | 2011/02/05 | Efficacy Supplement with Clinical Data to Support | | 020896 | 016 | AP | 2005/06/15 | New or Modified Indication | | 020896 | 012 | AP | 2003/03/15 | Labeling Revision | | 020896 | 011 | AP | 2001/09/07 | Labeling Revision | | 020896 | 010 | AP | 2001/09/07 | Accelerated Approval | | 020896 | 009 | AP | 2001/04/30 | Labeling Revision | | 020896 | 007 | AP | 2000/03/24 | Labeling Revision | | 020896 | 006 | AP | 2001/04/30 | New or Modified Indication | | 020896 | 005 | AP | 1999/08/17 | Control Supplement | | 020896 | 004 | AP | 1999/04/02 | Labeling Revision | | 020896 | 003 | AP | 1999/02/04 | Control Supplement | | 020896 | 002 | AP | 1999/02/04 | Manufacturing Change or Addition | | 020896 | 001 | AP | 1999/02/04 | Control Supplement | | 020896 | 000 | AP | 1998/04/30 | Approval |
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