| 药品名称 | LETAIRIS | | 申请号 | 022081 | 产品号 | 001 | | 活性成分 | AMBRISENTAN | 市场状态 | 处方药 | | 剂型或给药途径 | TABLET;ORAL | 规格 | 5MG | | 治疗等效代码 | | 参比药物 | 否 | | 批准日期 | 2007/06/15 | 申请机构 | GILEAD SCIENCES INC
| | 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 | | I-716 | 2018/10/02 | | 历史市场独占权保护信息 | | NCE | 2012/06/15 | | ODE | 2014/06/15 |
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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 | | 022081 | 033 | AP | Letter | 2015/10/06 | 下载 | | 022081 | 033 | AP | Label | 2015/10/08 | 下载 | | 022081 | 032 | AP | Letter | 2014/10/30 | 下载 | | 022081 | 030 | AP | Label | 2014/02/03 | 下载 | | 022081 | 030 | AP | Letter | 2014/02/04 | 下载 | | 022081 | 029 | AP | Letter | 2014/05/06 | 下载 | | 022081 | 029 | AP | Label | 2014/05/06 | 下载 | | 022081 | 022 | AP | Label | 2012/10/22 | 下载 | | 022081 | 022 | AP | Letter | 2012/10/23 | 下载 | | 022081 | 019 | AP | Label | 2013/08/21 | 下载 | | 022081 | 019 | AP | Letter | 2013/08/22 | 下载 | | 022081 | 018 | AP | Label | 2011/07/20 | 下载 | | 022081 | 018 | AP | Letter | 2011/07/21 | 下载 | | 022081 | 017 | AP | Label | 2011/03/07 | 下载 | | 022081 | 017 | AP | Letter | 2011/03/08 | 下载 | | 022081 | 017 | AP | Review | 2014/08/01 | 下载 | | 022081 | 016 | AP | Letter | 2010/08/26 | 下载 | | 022081 | 014 | AP | Letter | 2012/02/17 | 下载 | | 022081 | 014 | AP | Label | 2012/02/17 | 下载 | | 022081 | 012 | AP | Letter | 2010/10/20 | 下载 | | 022081 | 012 | AP | Label | 2010/10/25 | 下载 | | 022081 | 011 | AP | Letter | 2009/07/08 | 下载 | | 022081 | 011 | AP | Label | 2009/07/09 | 下载 | | 022081 | 010 | AP | Label | 2009/08/13 | 下载 | | 022081 | 010 | AP | Letter | 2009/11/24 | 下载 | | 022081 | 008 | AP | Letter | 2009/06/10 | 下载 | | 022081 | 008 | AP | Label | 2009/06/10 | 下载 | | 022081 | 004 | AP | Letter | 2008/10/14 | 下载 | | 022081 | 004 | AP | Label | 2008/11/07 | 下载 | | 022081 | 002 | AP | Letter | 2008/02/19 | 下载 | | 022081 | 002 | AP | Label | 2008/02/25 | 下载 | | 022081 | 001 | AP | Letter | 2007/12/03 | 下载 | | 022081 | 000 | AP | Other | 2010/09/01 | 下载 | | 022081 | 000 | AP | Medication Guide | 2009/09/02 | 下载 | | 022081 | 000 | AP | Label | 2007/06/27 | 下载 | | 022081 | 000 | AP | Letter | 2007/07/05 | 下载 | | 022081 | 000 | AP | Review | 2007/08/21 | 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 | | 022081 | 035 | AP | 2016/03/21 | Manufacturing Change or Addition | | 022081 | 034 | AP | 2015/09/25 | Manufacturing Change or Addition | | 022081 | 033 | AP | 2015/10/02 | Efficacy Supplement with Clinical Data to Support | | 022081 | 032 | AP | 2014/10/29 | Supplement | | 022081 | 030 | AP | 2014/01/31 | Labeling Revision | | 022081 | 029 | AP | 2014/05/05 | Labeling Revision | | 022081 | 028 | AP | 2014/09/26 | Manufacturing Change or Addition | | 022081 | 026 | AP | 2014/07/02 | Manufacturing Change or Addition | | 022081 | 024 | AP | 2013/01/16 | Manufacturing Change or Addition | | 022081 | 023 | AP | 2013/01/10 | Manufacturing Change or Addition | | 022081 | 022 | AP | 2012/10/19 | Labeling Revision | | 022081 | 019 | AP | 2013/08/17 | Labeling Revision | | 022081 | 018 | AP | 2011/07/19 | Labeling Revision | | 022081 | 017 | AP | 2011/03/03 | Labeling Revision | | 022081 | 016 | AP | 2010/08/24 | Labeling Revision | | 022081 | 014 | AP | 2012/02/15 | Efficacy Supplement with Clinical Data to Support | | 022081 | 012 | AP | 2010/10/13 | Labeling Revision | | 022081 | 011 | AP | 2009/07/01 | Labeling Revision | | 022081 | 010 | AP | 2009/08/05 | Labeling Revision | | 022081 | 008 | AP | 2009/05/29 | Labeling Revision | | 022081 | 004 | AP | 2008/10/08 | Labeling Revision | | 022081 | 002 | AP | 2008/02/14 | Labeling Revision | | 022081 | 001 | AP | 2007/11/29 | Labeling Revision | | 022081 | 000 | AP | 2007/06/15 | Approval |
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