| 药品名称 | MAXALT | | 申请号 | 020864 | 产品号 | 002 | | 活性成分 | RIZATRIPTAN BENZOATE | 市场状态 | 处方药 | | 剂型或给药途径 | TABLET;ORAL | 规格 | EQ 10MG BASE | | 治疗等效代码 | AB | 参比药物 | 是 | | 批准日期 | 1998/06/29 | 申请机构 | MERCK AND CO INC
| | 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 | | NPP | 2014/12/16 | | PED | 2015/06/16 |
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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 | | 020864 | 019 | AP | Label | 2011/12/20 | 下载 | | 020864 | 019 | AP | Letter | 2011/12/21 | 下载 | | 020864 | 018 | AP | Letter | 2011/12/21 | 下载 | | 020864 | 018 | AP | Label | 2011/12/20 | 下载 | | 020864 | 017 | AP | Label | 2011/12/20 | 下载 | | 020864 | 017 | AP | Letter | 2011/12/21 | 下载 | | 020864 | 016 | AP | Letter | 2011/12/21 | 下载 | | 020864 | 016 | AP | Label | 2011/12/20 | 下载 | | 020864 | 013 | AP | Letter | 2010/08/16 | 下载 | | 020864 | 013 | AP | Label | 2010/08/19 | 下载 | | 020864 | 011 | AP | Label | 2011/12/20 | 下载 | | 020864 | 011 | AP | Letter | 2011/12/21 | 下载 | | 020864 | 008 | AP | Review | 2008/08/01 | 下载 | | 020864 | 008 | AP | Letter | 2002/04/22 | 下载 | | 020864 | 007 | AP | Review | 2004/04/21 | 下载 | | 020864 | 005 | AP | Review | 2004/04/21 | 下载 | | 020864 | 004 | AP | Review | 2004/04/15 | 下载 | | 020864 | 003 | AP | Letter | 1999/12/30 | 下载 | | 020864 | 002 | AP | Review | 2004/04/15 | 下载 | | 020864 | 000 | AP | Other Important Information from FDA | 2003/12/12 | 下载 | | 020864 | 000 | AP | Letter | 1998/06/29 | 下载 | | 020864 | 000 | AP | Review | 1999/04/08 | 下载 | | 020864 | 000 | AP | Label | 1998/06/29 | 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 | | 020864 | 021 | AP | 2015/06/15 | Manufacturing Change or Addition | | 020864 | 020 | AP | 2014/05/29 | Manufacturing Change or Addition | | 020864 | 019 | AP | 2011/12/16 | Labeling Revision | | 020864 | 018 | AP | 2011/12/16 | Labeling Revision | | 020864 | 017 | AP | 2011/12/16 | Labeling Revision | | 020864 | 016 | AP | 2011/12/16 | Labeling Revision | | 020864 | 013 | AP | 2010/08/12 | Labeling Revision | | 020864 | 011 | AP | 2011/12/16 | Labeling Revision | | 020864 | 009 | AP | 2001/12/06 | Manufacturing Change or Addition | | 020864 | 008 | AP | 2002/04/22 | Labeling Revision | | 020864 | 007 | AP | 2000/12/11 | Labeling Revision | | 020864 | 006 | AP | 2001/01/25 | Manufacturing Change or Addition | | 020864 | 005 | AP | 2000/12/11 | Efficacy Supplement with Clinical Data to Support | | 020864 | 004 | AP | 2000/12/11 | Labeling Revision | | 020864 | 003 | AP | 1999/11/16 | Efficacy Supplement with Clinical Data to Support | | 020864 | 002 | AP | 2000/06/21 | Efficacy Supplement with Clinical Data to Support | | 020864 | 000 | AP | 1998/06/29 | Approval |
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