| 药品名称 | EVISTA | | 申请号 | 020815 | 产品号 | 001 | | 活性成分 | RALOXIFENE HYDROCHLORIDE | 市场状态 | 处方药 | | 剂型或给药途径 | TABLET;ORAL | 规格 | 60MG | | 治疗等效代码 | AB | 参比药物 | 是 | | 批准日期 | 1997/12/09 | 申请机构 | ELI LILLY AND CO
| | 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 | | 无 | | 历史市场独占权保护信息 | | I-539 | 2010/09/13 | | ODE | 2014/09/13 |
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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 | | 020815 | 025 | AP | Letter | 2007/09/25 | 下载 | | 020815 | 018 | AP | Letter | 2007/07/24 | 下载 | | 020815 | 018 | AP | Label | 2007/07/24 | 下载 | | 020815 | 003 | AP | Letter | 1999/09/30 | 下载 | | 020815 | 003 | AP | Review | 1999/09/30 | 下载 | | 020815 | 003 | AP | Label | 1999/09/30 | 下载 | | 020815 | 002 | AP | Review | 1998/11/24 | 下载 | | 020815 | 000 | AP | Medication Guide | 2009/11/18 | 下载 | | 020815 | 000 | AP | Review | 2009/12/03 | 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 | | 020815 | 033 | AP | 2016/01/25 | Manufacturing Change or Addition | | 020815 | 032 | AP | 2016/01/11 | Manufacturing Change or Addition | | 020815 | 025 | AP | 2007/09/13 | Other | | 020815 | 018 | AP | 2007/07/17 | Labeling Revision | | 020815 | 012 | AP | 2002/12/24 | Control Supplement | | 020815 | 011 | AP | 2002/05/07 | Control Supplement | | 020815 | 010 | AP | 2002/06/13 | Labeling Revision | | 020815 | 009 | AP | 2002/01/17 | Manufacturing Change or Addition | | 020815 | 008 | AP | 2001/07/02 | Control Supplement | | 020815 | 007 | AP | 2000/12/13 | Labeling Revision | | 020815 | 006 | AP | 2000/06/27 | Labeling Revision | | 020815 | 005 | AP | 2000/06/23 | Manufacturing Change or Addition | | 020815 | 004 | AP | 2000/05/09 | Control Supplement | | 020815 | 003 | AP | 1999/09/30 | New or Modified Indication | | 020815 | 002 | AP | 1998/11/24 | Efficacy Supplement with Clinical Data to Support | | 020815 | 001 | AP | 1998/10/26 | Control Supplement | | 020815 | 000 | AP | 1997/12/09 | Approval |
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