| 药品名称 | ZYVOX | | 申请号 | 021130 | 产品号 | 001 | | 活性成分 | LINEZOLID | 市场状态 | 停止上市 | | 剂型或给药途径 | TABLET;ORAL | 规格 | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | | 治疗等效代码 | | 参比药物 | 否 | | 批准日期 | 2000/04/18 | 申请机构 | PHARMACIA AND UPJOHN CO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-402 | 2006/07/22 | | I-431 | 2007/06/23 | | PED | 2007/01/22 | | PED | 2007/12/23 |
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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 | | 021130 | 035 | AP | Label | 2015/06/10 | 下载 | | 021130 | 035 | AP | Letter | 2015/06/10 | 下载 | | 021130 | 032 | AP | Label | 2014/01/27 | 下载 | | 021130 | 032 | AP | Letter | 2014/01/28 | 下载 | | 021130 | 028 | AP | Label | 2012/02/14 | 下载 | | 021130 | 028 | AP | Letter | 2012/02/15 | 下载 | | 021130 | 024 | AP | Letter | 2013/05/07 | 下载 | | 021130 | 024 | AP | Label | 2013/05/09 | 下载 | | 021130 | 023 | AP | Label | 2013/05/09 | 下载 | | 021130 | 023 | AP | Letter | 2013/05/07 | 下载 | | 021130 | 022 | AP | Label | 2010/07/19 | 下载 | | 021130 | 022 | AP | Letter | 2010/07/23 | 下载 | | 021130 | 020 | AP | Label | 2009/12/11 | 下载 | | 021130 | 020 | AP | Letter | 2010/01/26 | 下载 | | 021130 | 017 | AP | Letter | 2008/06/24 | 下载 | | 021130 | 016 | AP | Label | 2008/06/26 | 下载 | | 021130 | 016 | AP | Letter | 2008/06/24 | 下载 | | 021130 | 012 | AP | Label | 2007/05/01 | 下载 | | 021130 | 012 | AP | Letter | 2007/05/01 | 下载 | | 021130 | 012 | AP | Review | 2014/07/07 | 下载 | | 021130 | 010 | AP | Letter | 2005/11/08 | 下载 | | 021130 | 009 | AP | Letter | 2005/05/17 | 下载 | | 021130 | 009 | AP | Label | 2005/05/17 | 下载 | | 021130 | 008 | AP | Label | 2005/05/17 | 下载 | | 021130 | 008 | AP | Letter | 2005/05/17 | 下载 | | 021130 | 007 | AP | Letter | 2005/02/11 | 下载 | | 021130 | 006 | AP | Letter | 2004/06/25 | 下载 | | 021130 | 006 | AP | Label | 2004/06/25 | 下载 | | 021130 | 005 | AP | Letter | 2004/01/14 | 下载 | | 021130 | 004 | AP | Letter | 2003/07/28 | 下载 | | 021130 | 003 | AP | Review | 2005/06/27 | 下载 | | 021130 | 003 | AP | Letter | 2004/07/01 | 下载 | | 021130 | 003 | AP | Label | 2003/04/07 | 下载 | | 021130 | 002 | AP | Label | 2003/04/07 | 下载 | | 021130 | 002 | AP | Letter | 2004/07/01 | 下载 | | 021130 | 000 | AP | Letter | 2000/04/18 | 下载 | | 021130 | 000 | AP | Label | 2000/04/18 | 下载 | | 021130 | 000 | AP | Review | 2000/04/18 | 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 | | 021130 | 035 | AP | 2015/06/05 | Labeling Revision | | 021130 | 033 | AP | 2014/07/28 | Manufacturing Change or Addition | | 021130 | 032 | AP | 2014/01/24 | Labeling Revision | | 021130 | 028 | AP | 2012/02/13 | Labeling Revision | | 021130 | 024 | AP | 2013/05/03 | Labeling Revision | | 021130 | 023 | AP | 2013/05/03 | Labeling Revision | | 021130 | 022 | AP | 2010/07/16 | Labeling Revision | | 021130 | 020 | AP | 2009/12/08 | Labeling Revision | | 021130 | 019 | AP | 2008/02/19 | Manufacturing Change or Addition | | 021130 | 018 | AP | 2007/09/18 | Manufacturing Change or Addition | | 021130 | 017 | AP | 2008/06/20 | Labeling Revision | | 021130 | 016 | AP | 2008/06/20 | Labeling Revision | | 021130 | 015 | AP | 2007/06/08 | Manufacturing Change or Addition | | 021130 | 014 | AP | 2007/03/21 | Control Supplement | | 021130 | 013 | AP | 2007/03/26 | Manufacturing Change or Addition | | 021130 | 012 | AP | 2007/04/26 | Labeling Revision | | 021130 | 010 | AP | 2005/11/02 | Labeling Revision | | 021130 | 009 | AP | 2005/05/12 | Labeling Revision | | 021130 | 008 | AP | 2005/05/12 | Labeling Revision | | 021130 | 007 | AP | 2005/02/10 | Labeling Revision | | 021130 | 006 | AP | 2004/06/23 | Patient Population Altered | | 021130 | 005 | AP | 2004/01/05 | Labeling Revision | | 021130 | 004 | AP | 2003/07/22 | Efficacy Supplement with Clinical Data to Support | | 021130 | 003 | AP | 2002/12/19 | Patient Population Altered | | 021130 | 002 | AP | 2002/12/19 | Labeling Revision | | 021130 | 001 | AP | 2001/02/06 | Labeling Revision | | 021130 | 000 | AP | 2000/04/18 | Approval |
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