| 药品名称 | BARACLUDE | | 申请号 | 021798 | 产品号 | 001 | | 活性成分 | ENTECAVIR | 市场状态 | 处方药 | | 剂型或给药途径 | SOLUTION;ORAL | 规格 | 0.05MG/ML | | 治疗等效代码 | | 参比药物 | 是 | | 批准日期 | 2005/03/29 | 申请机构 | BRISTOL MYERS SQUIBB
| | 化学类型 | New dosage form | 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 | | NPP | 2015/10/12 | | NPP | 2017/03/20 | | PED | 2017/09/20 | | PED | 2016/04/12 | | 历史市场独占权保护信息 | | D-127 | 2013/10/15 | | NCE | 2010/03/29 | | PED | 2014/04/15 |
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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 | | 021798 | 019 | AP | Letter | 2014/03/21 | 下载 | | 021798 | 019 | AP | Label | 2014/03/25 | 下载 | | 021798 | 018 | AP | Letter | 2013/12/20 | 下载 | | 021798 | 018 | AP | Label | 2013/12/23 | 下载 | | 021798 | 016 | AP | Letter | 2012/10/15 | 下载 | | 021798 | 016 | AP | Label | 2012/10/15 | 下载 | | 021798 | 014 | AP | Label | 2012/10/15 | 下载 | | 021798 | 014 | AP | Letter | 2012/10/15 | 下载 | | 021798 | 012 | AP | Label | 2010/12/28 | 下载 | | 021798 | 012 | AP | Letter | 2011/01/04 | 下载 | | 021798 | 011 | AP | Label | 2010/10/29 | 下载 | | 021798 | 010 | AP | Letter | 2009/02/27 | 下载 | | 021798 | 010 | AP | Label | 2009/03/17 | 下载 | | 021798 | 008 | AP | Letter | 2009/07/22 | 下载 | | 021798 | 008 | AP | Label | 2009/07/24 | 下载 | | 021798 | 007 | AP | Letter | 2008/06/06 | 下载 | | 021798 | 006 | AP | Letter | 2008/07/31 | 下载 | | 021798 | 006 | AP | Label | 2008/08/13 | 下载 | | 021798 | 003 | AP | Label | 2007/07/27 | 下载 | | 021798 | 003 | AP | Letter | 2007/07/27 | 下载 | | 021798 | 002 | AP | Letter | 2007/03/31 | 下载 | | 021798 | 002 | AP | Label | 2007/03/31 | 下载 | | 021798 | 001 | AP | Label | 2007/02/26 | 下载 | | 021798 | 001 | AP | Letter | 2007/03/06 | 下载 | | 021798 | 000 | AP | Label | 2005/03/31 | 下载 | | 021798 | 000 | AP | Letter | 2005/03/31 | 下载 | | 021798 | 000 | AP | Review | 2005/12/06 | 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 | | 021798 | 019 | AP | 2014/03/20 | Efficacy Supplement with Clinical Data to Support | | 021798 | 018 | AP | 2013/12/18 | Labeling Revision | | 021798 | 017 | AP | 2013/06/18 | Manufacturing Change or Addition | | 021798 | 016 | AP | 2012/10/12 | Patient Population Altered | | 021798 | 014 | AP | 2012/10/12 | Patient Population Altered | | 021798 | 012 | AP | 2010/12/28 | Labeling Revision | | 021798 | 011 | AP | 2010/10/15 | Efficacy Supplement with Clinical Data to Support | | 021798 | 010 | AP | 2009/02/25 | Labeling Revision | | 021798 | 008 | AP | 2009/07/16 | Efficacy Supplement with Clinical Data to Support | | 021798 | 007 | AP | 2008/06/03 | Labeling Revision | | 021798 | 006 | AP | 2008/07/25 | Efficacy Supplement with Clinical Data to Support | | 021798 | 003 | AP | 2007/07/24 | Labeling Revision | | 021798 | 002 | AP | 2007/03/27 | New Dosage Regimen | | 021798 | 001 | AP | 2007/02/23 | Efficacy Supplement with Clinical Data to Support | | 021798 | 000 | AP | 2005/03/29 | Approval |
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