| 药品名称 | ZYVOX | | 申请号 | 021131 | 产品号 | 001 | | 活性成分 | LINEZOLID | 市场状态 | 处方药 | | 剂型或给药途径 | SOLUTION;IV (INFUSION) | 规格 | 200MG/100ML (2MG/ML) | | 治疗等效代码 | AP | 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 dosage form | 审评分类 | Priority review drug |
|
|
|
| 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 |
|
| 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 | | 021131 | 029 | AP | Label | 2015/06/10 | 下载 | | 021131 | 029 | AP | Letter | 2015/06/10 | 下载 | | 021131 | 026 | AP | Label | 2014/01/27 | 下载 | | 021131 | 026 | AP | Letter | 2014/01/28 | 下载 | | 021131 | 024 | AP | Label | 2012/02/14 | 下载 | | 021131 | 024 | AP | Letter | 2012/02/15 | 下载 | | 021131 | 022 | AP | Letter | 2013/05/07 | 下载 | | 021131 | 022 | AP | Label | 2013/05/09 | 下载 | | 021131 | 021 | AP | Label | 2013/05/09 | 下载 | | 021131 | 021 | AP | Letter | 2013/05/07 | 下载 | | 021131 | 020 | AP | Label | 2010/07/16 | 下载 | | 021131 | 020 | AP | Letter | 2010/07/23 | 下载 | | 021131 | 017 | AP | Label | 2009/12/11 | 下载 | | 021131 | 017 | AP | Letter | 2010/01/26 | 下载 | | 021131 | 014 | AP | Letter | 2008/06/24 | 下载 | | 021131 | 013 | AP | Label | 2008/06/26 | 下载 | | 021131 | 013 | AP | Letter | 2008/06/24 | 下载 | | 021131 | 012 | AP | Label | 2007/05/01 | 下载 | | 021131 | 012 | AP | Letter | 2007/05/01 | 下载 | | 021131 | 012 | AP | Review | 2014/07/07 | 下载 | | 021131 | 011 | AP | Letter | 2005/11/08 | 下载 | | 021131 | 010 | AP | Letter | 2005/05/17 | 下载 | | 021131 | 010 | AP | Label | 2005/05/17 | 下载 | | 021131 | 009 | AP | Label | 2005/05/17 | 下载 | | 021131 | 009 | AP | Letter | 2005/05/17 | 下载 | | 021131 | 008 | AP | Letter | 2005/02/11 | 下载 | | 021131 | 007 | AP | Letter | 2004/06/25 | 下载 | | 021131 | 007 | AP | Label | 2004/06/25 | 下载 | | 021131 | 006 | AP | Letter | 2004/01/14 | 下载 | | 021131 | 004 | AP | Letter | 2003/07/28 | 下载 | | 021131 | 003 | AP | Review | 2005/07/11 | 下载 | | 021131 | 003 | AP | Letter | 2004/07/01 | 下载 | | 021131 | 003 | AP | Label | 2003/04/07 | 下载 | | 021131 | 002 | AP | Label | 2003/04/07 | 下载 | | 021131 | 002 | AP | Letter | 2004/07/01 | 下载 | | 021131 | 000 | AP | Letter | 2000/04/18 | 下载 | | 021131 | 000 | AP | Label | 2000/04/18 | 下载 | | 021131 | 000 | AP | Review | 2000/04/18 | 下载 |
|
| 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 | | 021131 | 029 | AP | 2015/06/05 | Labeling Revision | | 021131 | 027 | AP | 2014/07/28 | Manufacturing Change or Addition | | 021131 | 026 | AP | 2014/01/24 | Labeling Revision | | 021131 | 024 | AP | 2012/02/13 | Labeling Revision | | 021131 | 022 | AP | 2013/05/03 | Labeling Revision | | 021131 | 021 | AP | 2013/05/03 | Labeling Revision | | 021131 | 020 | AP | 2010/07/16 | Labeling Revision | | 021131 | 017 | AP | 2009/12/08 | Labeling Revision | | 021131 | 016 | AP | 2007/09/18 | Manufacturing Change or Addition | | 021131 | 015 | AP | 2007/08/02 | Control Supplement | | 021131 | 014 | AP | 2008/06/20 | Labeling Revision | | 021131 | 013 | AP | 2008/06/20 | Labeling Revision | | 021131 | 012 | AP | 2007/04/26 | Labeling Revision | | 021131 | 011 | AP | 2005/11/02 | Labeling Revision | | 021131 | 010 | AP | 2005/05/12 | Labeling Revision | | 021131 | 009 | AP | 2005/05/12 | Labeling Revision | | 021131 | 008 | AP | 2005/02/10 | Labeling Revision | | 021131 | 007 | AP | 2004/06/23 | Patient Population Altered | | 021131 | 006 | AP | 2004/01/05 | Labeling Revision | | 021131 | 004 | AP | 2003/07/22 | Efficacy Supplement with Clinical Data to Support | | 021131 | 003 | AP | 2002/12/19 | Patient Population Altered | | 021131 | 002 | AP | 2002/12/19 | Labeling Revision | | 021131 | 001 | AP | 2001/02/06 | Labeling Revision | | 021131 | 000 | AP | 2000/04/18 | Approval |
|