| 药品名称 | LOVAZA | | 申请号 | 021654 | 产品号 | 001 | | 活性成分 | OMEGA-3-ACID ETHYL ESTERS | 市场状态 | 处方药 | | 剂型或给药途径 | CAPSULE;ORAL | 规格 | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | | 治疗等效代码 | AB | 参比药物 | 是 | | 批准日期 | 2004/11/10 | 申请机构 | SMITHKLINE BEECHAM
| | 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 | | M-64 | 2010/06/12 | | NCE | 2009/11/10 |
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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 | | 021654 | 041 | AP | Label | 2014/05/14 | 下载 | | 021654 | 041 | AP | Letter | 2014/05/14 | 下载 | | 021654 | 039 | AP | Label | 2013/09/17 | 下载 | | 021654 | 037 | AP | Letter | 2013/06/27 | 下载 | | 021654 | 037 | AP | Label | 2013/07/08 | 下载 | | 021654 | 034 | AP | Letter | 2012/09/06 | 下载 | | 021654 | 034 | AP | Label | 2012/09/06 | 下载 | | 021654 | 033 | AP | Letter | 2011/09/21 | 下载 | | 021654 | 030 | AP | Label | 2010/12/26 | 下载 | | 021654 | 030 | AP | Letter | 2010/12/28 | 下载 | | 021654 | 023 | AP | Letter | 2009/04/21 | 下载 | | 021654 | 023 | AP | Label | 2009/04/23 | 下载 | | 021654 | 022 | AP | Label | 2009/09/21 | 下载 | | 021654 | 022 | AP | Letter | 2009/11/10 | 下载 | | 021654 | 021 | AP | Letter | 2008/06/06 | 下载 | | 021654 | 021 | AP | Label | 2008/06/19 | 下载 | | 021654 | 018 | AP | Review | 2011/12/14 | 下载 | | 021654 | 016 | AP | Review | 2009/11/19 | 下载 | | 021654 | 016 | AP | Letter | 2007/07/05 | 下载 | | 021654 | 015 | AP | Letter | 2008/01/09 | 下载 | | 021654 | 014 | AP | Patient Information Sheet | 2007/11/07 | 下载 | | 021654 | 014 | AP | Letter | 2007/11/08 | 下载 | | 021654 | 007 | AP | Letter | 2006/07/13 | 下载 | | 021654 | 004 | AP | Label | 2007/02/02 | 下载 | | 021654 | 004 | AP | Letter | 2007/02/12 | 下载 | | 021654 | 000 | AP | Letter | 2004/11/16 | 下载 | | 021654 | 000 | AP | Label | 2004/11/16 | 下载 | | 021654 | 000 | AP | Review | 2005/01/11 | 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 | | 021654 | 042 | AP | 2015/03/09 | Manufacturing Change or Addition | | 021654 | 041 | AP | 2014/05/14 | Labeling Revision | | 021654 | 040 | AP | 2014/06/05 | Manufacturing Change or Addition | | 021654 | 039 | AP | 2013/09/11 | Manufacturing Change or Addition | | 021654 | 038 | AP | 2013/11/15 | Manufacturing Change or Addition | | 021654 | 037 | AP | 2013/06/26 | Labeling Revision | | 021654 | 034 | AP | 2012/09/04 | Labeling Revision | | 021654 | 033 | AP | 2011/09/19 | Labeling Revision | | 021654 | 031 | AP | 2011/08/11 | Labeling Revision | | 021654 | 030 | AP | 2010/12/22 | Labeling Revision | | 021654 | 023 | AP | 2009/04/20 | Labeling Revision | | 021654 | 022 | AP | 2009/09/16 | Efficacy Supplement with Clinical Data to Support | | 021654 | 021 | AP | 2008/06/03 | Labeling Revision | | 021654 | 018 | AP | 2008/01/24 | Manufacturing Change or Addition | | 021654 | 016 | AP | 2007/06/12 | Labeling Revision | | 021654 | 015 | AP | 2007/12/06 | Manufacturing Change or Addition | | 021654 | 014 | AP | 2007/11/07 | Labeling Revision | | 021654 | 007 | AP | 2006/07/03 | Manufacturing Change or Addition | | 021654 | 004 | AP | 2007/02/01 | Labeling Revision | | 021654 | 000 | AP | 2004/11/10 | Approval |
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