| 药品名称 | VIOXX | | 申请号 | 021052 | 产品号 | 002 | | 活性成分 | ROFECOXIB | 市场状态 | 停止上市 | | 剂型或给药途径 | SUSPENSION;ORAL | 规格 | 25MG/5ML | | 治疗等效代码 | | 参比药物 | 否 | | 批准日期 | 1999/05/20 | 申请机构 | MERCK RESEARCH LABORATORIES DIV MERCK CO INC
| | 化学类型 | New dosage form | 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 | | M-27 | 2006/08/06 | | PED | 2007/02/06 |
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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 | | 021052 | 024 | AP | Letter | 2016/05/11 | 下载 | | 021052 | 024 | AP | Label | 2016/05/11 | 下载 | | 021052 | 021 | AP | Letter | 2004/09/16 | 下载 | | 021052 | 021 | AP | Review | 2008/07/31 | 下载 | | 021052 | 019 | AP | Review | 2008/07/31 | 下载 | | 021052 | 019 | AP | Label | 2004/08/19 | 下载 | | 021052 | 019 | AP | Letter | 2004/08/25 | 下载 | | 021052 | 017 | AP | Review | 2006/06/01 | 下载 | | 021052 | 017 | AP | Letter | 2003/12/19 | 下载 | | 021052 | 016 | AP | Review | 2006/06/01 | 下载 | | 021052 | 016 | AP | Letter | 2003/07/06 | 下载 | | 021052 | 015 | AP | Letter | 2003/07/06 | 下载 | | 021052 | 015 | AP | Review | 2006/06/01 | 下载 | | 021052 | 014 | AP | Review | 2006/06/01 | 下载 | | 021052 | 014 | AP | Letter | 2003/07/06 | 下载 | | 021052 | 012 | AP | Label | 2003/08/15 | 下载 | | 021052 | 012 | AP | Letter | 2003/08/15 | 下载 | | 021052 | 011 | AP | Review | 2006/06/01 | 下载 | | 021052 | 010 | AP | Review | 2008/08/01 | 下载 | | 021052 | 009 | AP | Review | 2004/06/30 | 下载 | | 021052 | 009 | AP | Letter | 2004/06/30 | 下载 | | 021052 | 009 | AP | Label | 2004/06/30 | 下载 | | 021052 | 008 | AP | Letter | 2004/06/30 | 下载 | | 021052 | 008 | AP | Label | 2004/06/30 | 下载 | | 021052 | 008 | AP | Review | 2004/06/30 | 下载 | | 021052 | 007 | AP | Letter | 2002/04/11 | 下载 | | 021052 | 007 | AP | Label | 2002/04/11 | 下载 | | 021052 | 007 | AP | Review | 2002/04/11 | 下载 | | 021052 | 006 | AP | Letter | 2002/04/11 | 下载 | | 021052 | 006 | AP | Label | 2002/04/11 | 下载 | | 021052 | 006 | AP | Review | 2002/04/11 | 下载 | | 021052 | 005 | AP | Letter | 2002/04/11 | 下载 | | 021052 | 005 | AP | Label | 2002/04/11 | 下载 | | 021052 | 005 | AP | Review | 2002/04/11 | 下载 | | 021052 | 004 | AP | Letter | 2002/04/11 | 下载 | | 021052 | 004 | AP | Label | 2002/04/11 | 下载 | | 021052 | 004 | AP | Review | 2002/04/11 | 下载 | | 021052 | 000 | AP | Letter | 1999/05/20 | 下载 | | 021052 | 000 | AP | Label | 1999/05/20 | 下载 | | 021052 | 000 | AP | Review | 1999/05/20 | 下载 | | 021052 | 000 | AP | Other | 2004/09/30 | 下载 | | 021052 | 000 | AP | Other Important Information from FDA | 2004/09/30 | 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 | | 021052 | 024 | AP | 2016/05/09 | Labeling Revision | | 021052 | 021 | AP | 2004/09/14 | Labeling Revision | | 021052 | 019 | AP | 2004/08/19 | Patient Population Altered | | 021052 | 017 | AP | 2003/12/16 | Labeling Revision | | 021052 | 016 | AP | 2003/06/27 | Labeling Revision | | 021052 | 015 | AP | 2003/06/27 | Labeling Revision | | 021052 | 014 | AP | 2003/06/27 | Labeling Revision | | 021052 | 012 | AP | 2003/08/06 | Efficacy Supplement with Clinical Data to Support | | 021052 | 011 | AP | 2003/05/19 | Labeling Revision | | 021052 | 010 | AP | 2002/06/25 | Manufacturing Change or Addition | | 021052 | 009 | AP | 2002/04/11 | Labeling Revision | | 021052 | 008 | AP | 2002/04/11 | Labeling Revision | | 021052 | 007 | AP | 2002/04/11 | New or Modified Indication | | 021052 | 006 | AP | 2002/04/11 | Labeling Revision | | 021052 | 005 | AP | 2002/04/11 | Labeling Revision | | 021052 | 004 | AP | 2002/04/11 | Efficacy Supplement with Clinical Data to Support | | 021052 | 003 | AP | 2000/03/17 | Labeling Revision | | 021052 | 002 | AP | 2000/03/02 | Expiration Date Change | | 021052 | 001 | AP | 1999/10/28 | Labeling Revision | | 021052 | 000 | AP | 1999/05/20 | Approval |
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