| 药品名称 | RANEXA | | 申请号 | 021526 | 产品号 | 001 | | 活性成分 | RANOLAZINE | 市场状态 | 处方药 | | 剂型或给药途径 | TABLET, EXTENDED RELEASE;ORAL | 规格 | 1GM | | 治疗等效代码 | AB | 参比药物 | 是 | | 批准日期 | 2007/02/12 | 申请机构 | GILEAD SCIENCES INC
| | 化学类型 | New molecular entity (NME) | 审评分类 | Standard 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 | | 无 | | 历史市场独占权保护信息 | | NCE | 2011/01/27 |
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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 | | 021526 | 029 | AP | Letter | 2016/01/07 | 下载 | | 021526 | 029 | AP | Label | 2016/01/07 | 下载 | | 021526 | 028 | AP | Letter | 2015/12/16 | 下载 | | 021526 | 028 | AP | Label | 2015/12/17 | 下载 | | 021526 | 026 | AP | Letter | 2013/12/20 | 下载 | | 021526 | 026 | AP | Label | 2013/12/23 | 下载 | | 021526 | 025 | AP | Label | 2013/11/14 | 下载 | | 021526 | 025 | AP | Letter | 2013/11/15 | 下载 | | 021526 | 022 | AP | Label | 2012/07/26 | 下载 | | 021526 | 022 | AP | Letter | 2012/07/30 | 下载 | | 021526 | 018 | AP | Label | 2011/12/23 | 下载 | | 021526 | 018 | AP | Letter | 2011/12/28 | 下载 | | 021526 | 014 | AP | Label | 2011/07/11 | 下载 | | 021526 | 014 | AP | Letter | 2011/07/13 | 下载 | | 021526 | 012 | AP | Letter | 2010/09/28 | 下载 | | 021526 | 012 | AP | Label | 2010/09/29 | 下载 | | 021526 | 007 | AP | Label | 2009/03/26 | 下载 | | 021526 | 007 | AP | Letter | 2009/03/27 | 下载 | | 021526 | 007 | AP | Review | 2014/08/05 | 下载 | | 021526 | 004 | AP | Review | 2015/01/16 | 下载 | | 021526 | 004 | AP | Letter | 2008/11/06 | 下载 | | 021526 | 004 | AP | Label | 2008/11/07 | 下载 | | 021526 | 002 | AP | Label | 2007/12/27 | 下载 | | 021526 | 002 | AP | Letter | 2008/01/09 | 下载 | | 021526 | 000 | AP | Label | 2006/02/07 | 下载 | | 021526 | 000 | AP | Letter | 2006/02/08 | 下载 | | 021526 | 000 | AP | Review | 2006/04/06 | 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 | | 021526 | 033 | AP | 2016/04/22 | Manufacturing Change or Addition | | 021526 | 030 | AP | 2015/11/10 | Manufacturing Change or Addition | | 021526 | 029 | AP | 2016/01/06 | Supplement | | 021526 | 028 | AP | 2015/12/15 | Labeling Revision | | 021526 | 027 | AP | 2014/01/17 | Manufacturing Change or Addition | | 021526 | 026 | AP | 2013/12/19 | Labeling Revision | | 021526 | 025 | AP | 2013/11/12 | Labeling Revision | | 021526 | 022 | AP | 2012/07/25 | Labeling Revision | | 021526 | 018 | AP | 2011/12/21 | Labeling Revision | | 021526 | 014 | AP | 2011/07/11 | Labeling Revision | | 021526 | 012 | AP | 2010/09/23 | Labeling Revision | | 021526 | 007 | AP | 2009/03/26 | Manufacturing Change or Addition | | 021526 | 004 | AP | 2008/11/05 | New or Modified Indication | | 021526 | 002 | AP | 2007/12/17 | Labeling Revision | | 021526 | 000 | AP | 2006/01/27 | Approval |
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