| 药品名称 | EMEND | | 申请号 | 021549 | 产品号 | 001 | | 活性成分 | APREPITANT | 市场状态 | 处方药 | | 剂型或给药途径 | CAPSULE;ORAL | 规格 | 80MG | | 治疗等效代码 | AB | 参比药物 | 否 | | 批准日期 | 2003/03/26 | 申请机构 | MERCK AND CO INC
| | 化学类型 | New molecular entity (NME) | 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 | 2018/08/28 | | 历史市场独占权保护信息 | | I-475 | 2008/10/28 | | NCE | 2008/03/26 |
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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 | | 021549 | 025 | AP | Letter | 2015/09/01 | 下载 | | 021549 | 025 | AP | Label | 2015/09/03 | 下载 | | 021549 | 024 | AP | Label | 2014/08/13 | 下载 | | 021549 | 024 | AP | Letter | 2014/08/14 | 下载 | | 021549 | 023 | AP | Letter | 2013/03/29 | 下载 | | 021549 | 023 | AP | Label | 2013/04/01 | 下载 | | 021549 | 021 | AP | Label | 2012/07/10 | 下载 | | 021549 | 021 | AP | Letter | 2012/07/11 | 下载 | | 021549 | 019 | AP | Letter | 2013/03/22 | 下载 | | 021549 | 019 | AP | Label | 2013/03/26 | 下载 | | 021549 | 017 | AP | Letter | 2010/03/25 | 下载 | | 021549 | 017 | AP | Label | 2010/03/26 | 下载 | | 021549 | 016 | AP | Letter | 2009/02/04 | 下载 | | 021549 | 016 | AP | Label | 2009/02/04 | 下载 | | 021549 | 015 | AP | Label | 2008/11/19 | 下载 | | 021549 | 015 | AP | Letter | 2008/11/21 | 下载 | | 021549 | 014 | AP | Letter | 2009/07/23 | 下载 | | 021549 | 014 | AP | Label | 2009/07/23 | 下载 | | 021549 | 012 | AP | Label | 2007/11/19 | 下载 | | 021549 | 012 | AP | Letter | 2007/11/19 | 下载 | | 021549 | 011 | AP | Letter | 2006/06/12 | 下载 | | 021549 | 011 | AP | Label | 2006/06/14 | 下载 | | 021549 | 010 | AP | Label | 2006/07/03 | 下载 | | 021549 | 010 | AP | Letter | 2006/07/13 | 下载 | | 021549 | 009 | AP | Letter | 2005/06/14 | 下载 | | 021549 | 009 | AP | Label | 2005/06/14 | 下载 | | 021549 | 008 | AP | Label | 2005/11/01 | 下载 | | 021549 | 008 | AP | Letter | 2005/11/01 | 下载 | | 021549 | 008 | AP | Review | 2012/03/02 | 下载 | | 021549 | 007 | AP | Letter | 2004/12/29 | 下载 | | 021549 | 007 | AP | Label | 2004/12/29 | 下载 | | 021549 | 004 | AP | Letter | 2004/12/30 | 下载 | | 021549 | 004 | AP | Label | 2004/12/30 | 下载 | | 021549 | 002 | AP | Review | 2007/11/19 | 下载 | | 021549 | 002 | AP | Letter | 2004/01/22 | 下载 | | 021549 | 000 | AP | Label | 2003/03/28 | 下载 | | 021549 | 000 | AP | Letter | 2003/03/28 | 下载 | | 021549 | 000 | AP | Review | 2003/07/06 | 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 | | 021549 | 026 | AP | 2015/01/12 | Manufacturing Change or Addition | | 021549 | 025 | AP | 2015/08/28 | Efficacy Supplement with Clinical Data to Support | | 021549 | 024 | AP | 2014/08/12 | Labeling Revision | | 021549 | 023 | AP | 2013/03/27 | Labeling Revision | | 021549 | 021 | AP | 2012/07/06 | Labeling Revision | | 021549 | 019 | AP | 2013/03/20 | Labeling Revision | | 021549 | 017 | AP | 2010/03/19 | Efficacy Supplement with Clinical Data to Support | | 021549 | 016 | AP | 2009/02/02 | Labeling Revision | | 021549 | 015 | AP | 2008/11/18 | Labeling Revision | | 021549 | 014 | AP | 2009/07/21 | Labeling Revision | | 021549 | 012 | AP | 2007/11/15 | Labeling Revision | | 021549 | 011 | AP | 2006/06/09 | Labeling Revision | | 021549 | 010 | AP | 2006/06/30 | New or Modified Indication | | 021549 | 009 | AP | 2005/06/09 | Labeling Revision | | 021549 | 008 | AP | 2005/10/28 | New or Modified Indication | | 021549 | 007 | AP | 2004/12/22 | Labeling Revision | | 021549 | 004 | AP | 2004/12/15 | Labeling Revision | | 021549 | 002 | AP | 2004/01/15 | Labeling Revision | | 021549 | 000 | AP | 2003/03/27 | Approval |
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