| 药品名称 | DULERA | | 申请号 | 022518 | 产品号 | 001 | | 活性成分 | FORMOTEROL FUMARATE; MOMETASONE FUROATE | 市场状态 | 处方药 | | 剂型或给药途径 | AEROSOL, METERED;INHALATION | 规格 | 0.005MG/INH;0.1MG/INH | | 治疗等效代码 | | 参比药物 | 是 | | 批准日期 | 2010/06/22 | 申请机构 | MERCK SHARP AND DOHME CORP
| | 化学类型 | New combination | 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 | | 无 |
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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 | | 022518 | 019 | AP | Letter | 2016/07/13 | 下载 | | 022518 | 019 | AP | Label | 2016/07/13 | 下载 | | 022518 | 018 | AP | Letter | 2015/12/29 | 下载 | | 022518 | 015 | AP | Label | 2015/04/24 | 下载 | | 022518 | 014 | AP | Letter | 2014/04/18 | 下载 | | 022518 | 013 | AP | Label | 2013/08/22 | 下载 | | 022518 | 013 | AP | Letter | 2013/08/22 | 下载 | | 022518 | 011 | AP | Letter | 2013/08/01 | 下载 | | 022518 | 011 | AP | Label | 2013/08/09 | 下载 | | 022518 | 010 | AP | Letter | 2012/11/29 | 下载 | | 022518 | 008 | AP | Letter | 2013/01/17 | 下载 | | 022518 | 008 | AP | Label | 2013/01/22 | 下载 | | 022518 | 007 | AP | Letter | 2012/11/29 | 下载 | | 022518 | 006 | AP | Letter | 2012/11/26 | 下载 | | 022518 | 006 | AP | Label | 2012/11/28 | 下载 | | 022518 | 005 | AP | Label | 2012/08/22 | 下载 | | 022518 | 005 | AP | Medication Guide | 2012/08/22 | 下载 | | 022518 | 005 | AP | Letter | 2012/08/23 | 下载 | | 022518 | 004 | AP | Letter | 2011/08/22 | 下载 | | 022518 | 004 | AP | Label | 2011/08/24 | 下载 | | 022518 | 002 | AP | Label | 2011/08/24 | 下载 | | 022518 | 002 | AP | Letter | 2011/08/22 | 下载 | | 022518 | 000 | AP | Medication Guide | 2010/06/24 | 下载 | | 022518 | 000 | AP | Label | 2010/06/24 | 下载 | | 022518 | 000 | AP | Letter | 2010/06/29 | 下载 | | 022518 | 000 | AP | Other | 2010/06/30 | 下载 | | 022518 | 000 | AP | Review | 2011/05/25 | 下载 | | 022518 | 000 | AP | Summary Review | 2011/05/25 | 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 | | 022518 | 020 | AP | 2016/05/12 | Manufacturing Change or Addition | | 022518 | 019 | AP | 2016/07/12 | Efficacy Supplement with Clinical Data to Support | | 022518 | 018 | AP | 2015/12/24 | Labeling Revision | | 022518 | 017 | AP | 2015/09/18 | Manufacturing Change or Addition | | 022518 | 016 | AP | 2015/08/06 | Manufacturing Change or Addition | | 022518 | 015 | AP | 2015/04/23 | Labeling Revision | | 022518 | 014 | AP | 2014/04/17 | Labeling Revision | | 022518 | 013 | AP | 2013/08/21 | Labeling Revision | | 022518 | 012 | AP | 2013/06/10 | Manufacturing Change or Addition | | 022518 | 011 | AP | 2013/07/30 | Labeling Revision | | 022518 | 010 | AP | 2012/11/27 | Labeling Revision | | 022518 | 009 | AP | 2013/01/25 | Manufacturing Change or Addition | | 022518 | 008 | AP | 2013/01/15 | Labeling Revision | | 022518 | 007 | AP | 2012/11/27 | Labeling Revision | | 022518 | 006 | AP | 2012/11/13 | Labeling Revision | | 022518 | 005 | AP | 2012/08/21 | Labeling Revision | | 022518 | 004 | AP | 2011/08/18 | Labeling Revision | | 022518 | 002 | AP | 2011/08/18 | Labeling Revision | | 022518 | 000 | AP | 2010/06/22 | Approval |
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