| 药品名称 | SPRYCEL | | 申请号 | 021986 | 产品号 | 004 | | 活性成分 | DASATINIB | 市场状态 | 处方药 | | 剂型或给药途径 | TABLET;ORAL | 规格 | 100MG | | 治疗等效代码 | AB | 参比药物 | 是 | | 批准日期 | 2008/05/30 | 申请机构 | BRISTOL MYERS SQUIBB CO
| | 化学类型 | New molecular entity (NME) | 审评分类 | Priority review drug | | 罕用药/孤儿药 | 是 | | |
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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 | | 无 | | 历史市场独占权保护信息 | | D-109 | 2010/11/06 | | M-70 | 2010/11/06 | | M-94 | 2013/10/28 | | NCE | 2011/06/28 | | ODE | 2013/06/28 |
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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 | | 021986 | 018 | AP | Label | 2016/09/29 | 下载 | | 021986 | 018 | AP | Letter | 2016/09/30 | 下载 | | 021986 | 017 | AP | Label | 2015/08/13 | 下载 | | 021986 | 017 | AP | Letter | 2015/08/14 | 下载 | | 021986 | 016 | AP | Letter | 2015/08/14 | 下载 | | 021986 | 016 | AP | Label | 2015/08/13 | 下载 | | 021986 | 014 | AP | Letter | 2014/04/14 | 下载 | | 021986 | 014 | AP | Label | 2014/05/12 | 下载 | | 021986 | 013 | AP | Label | 2013/06/17 | 下载 | | 021986 | 013 | AP | Letter | 2013/06/18 | 下载 | | 021986 | 010 | AP | Label | 2011/10/12 | 下载 | | 021986 | 010 | AP | Letter | 2011/10/13 | 下载 | | 021986 | 009 | AP | Letter | 2011/10/13 | 下载 | | 021986 | 009 | AP | Label | 2011/10/12 | 下载 | | 021986 | 008 | AP | Letter | 2010/11/03 | 下载 | | 021986 | 008 | AP | Label | 2010/10/28 | 下载 | | 021986 | 007 | AP | Letter | 2010/11/03 | 下载 | | 021986 | 007 | AP | Label | 2010/10/28 | 下载 | | 021986 | 005 | AP | Label | 2010/07/31 | 下载 | | 021986 | 005 | AP | Letter | 2010/08/09 | 下载 | | 021986 | 004 | AP | Label | 2009/05/25 | 下载 | | 021986 | 004 | AP | Letter | 2009/05/29 | 下载 | | 021986 | 003 | AP | Letter | 2008/06/03 | 下载 | | 021986 | 002 | AP | Review | 2011/09/22 | 下载 | | 021986 | 002 | AP | Label | 2007/11/13 | 下载 | | 021986 | 002 | AP | Letter | 2007/11/19 | 下载 | | 021986 | 001 | AP | Letter | 2007/11/19 | 下载 | | 021986 | 001 | AP | Review | 2011/09/22 | 下载 | | 021986 | 000 | AP | Label | 2006/07/03 | 下载 | | 021986 | 000 | AP | Letter | 2006/07/03 | 下载 | | 021986 | 000 | AP | Review | 2006/09/06 | 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 | | 021986 | 018 | AP | 2016/09/27 | Labeling Revision | | 021986 | 017 | AP | 2015/08/12 | Labeling Revision | | 021986 | 016 | AP | 2015/08/12 | Efficacy Supplement with Clinical Data to Support | | 021986 | 015 | AP | 2015/01/26 | Manufacturing Change or Addition | | 021986 | 014 | AP | 2014/04/10 | Labeling Revision | | 021986 | 013 | AP | 2013/06/17 | Labeling Revision | | 021986 | 010 | AP | 2011/10/07 | Labeling Revision | | 021986 | 009 | AP | 2011/10/07 | Labeling Revision | | 021986 | 008 | AP | 2010/10/28 | New or Modified Indication | | 021986 | 007 | AP | 2010/10/28 | Efficacy Supplement with Clinical Data to Support | | 021986 | 005 | AP | 2010/07/28 | Labeling Revision | | 021986 | 004 | AP | 2009/05/21 | New Dosage Regimen | | 021986 | 003 | AP | 2008/05/30 | Control Supplement | | 021986 | 002 | AP | 2007/11/08 | Efficacy Supplement with Clinical Data to Support | | 021986 | 001 | AP | 2007/11/08 | New Dosage Regimen | | 021986 | 000 | AP | 2006/06/28 | Approval |
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