| 药品名称 | TEFLARO | | 申请号 | 200327 | 产品号 | 002 | | 活性成分 | CEFTAROLINE FOSAMIL | 市场状态 | 处方药 | | 剂型或给药途径 | POWDER;IV (INFUSION) | 规格 | 600MG/VIAL | | 治疗等效代码 | | 参比药物 | 是 | | 批准日期 | 2010/10/29 | 申请机构 | CEREXA 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 | | NCE | 2015/10/29 | | NPP | 2019/05/27 | | NPP | 2019/05/27 | | 历史市场独占权保护信息 | | 无 |
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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 | | 200327 | 017 | AP | Letter | 2016/05/31 | 下载 | | 200327 | 017 | AP | Label | 2016/06/01 | 下载 | | 200327 | 016 | AP | Letter | 2016/05/31 | 下载 | | 200327 | 016 | AP | Label | 2016/06/01 | 下载 | | 200327 | 015 | AP | Letter | 2015/09/04 | 下载 | | 200327 | 015 | AP | Label | 2015/09/04 | 下载 | | 200327 | 014 | AP | Label | 2015/09/04 | 下载 | | 200327 | 014 | AP | Letter | 2015/09/04 | 下载 | | 200327 | 013 | AP | Letter | 2015/09/04 | 下载 | | 200327 | 011 | AP | Letter | 2013/12/17 | 下载 | | 200327 | 011 | AP | Label | 2013/12/17 | 下载 | | 200327 | 010 | AP | Letter | 2015/03/23 | 下载 | | 200327 | 010 | AP | Label | 2015/03/26 | 下载 | | 200327 | 009 | AP | Letter | 2013/05/30 | 下载 | | 200327 | 009 | AP | Label | 2013/06/04 | 下载 | | 200327 | 008 | AP | Letter | 2012/10/24 | 下载 | | 200327 | 008 | AP | Label | 2012/10/24 | 下载 | | 200327 | 007 | AP | Label | 2012/05/07 | 下载 | | 200327 | 005 | AP | Letter | 2012/05/24 | 下载 | | 200327 | 003 | AP | Label | 2011/03/14 | 下载 | | 200327 | 003 | AP | Letter | 2011/03/16 | 下载 | | 200327 | 001 | AP | Label | 2011/06/30 | 下载 | | 200327 | 001 | AP | Letter | 2011/07/06 | 下载 | | 200327 | 000 | AP | Label | 2010/10/29 | 下载 | | 200327 | 000 | AP | Letter | 2010/11/03 | 下载 | | 200327 | 000 | AP | Review | 2010/12/13 | 下载 | | 200327 | 000 | AP | Summary Review | 2010/12/14 | 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 | | 200327 | 018 | AP | 2016/08/11 | Manufacturing Change or Addition | | 200327 | 017 | AP | 2016/05/27 | Efficacy Supplement with Clinical Data to Support | | 200327 | 016 | AP | 2016/05/27 | Efficacy Supplement with Clinical Data to Support | | 200327 | 015 | AP | 2015/08/31 | Labeling Revision | | 200327 | 014 | AP | 2015/08/31 | Efficacy Supplement with Clinical Data to Support | | 200327 | 013 | AP | 2015/08/31 | Efficacy Supplement with Clinical Data to Support | | 200327 | 012 | AP | 2014/02/28 | Manufacturing Change or Addition | | 200327 | 011 | AP | 2013/12/16 | Labeling Revision | | 200327 | 010 | AP | 2013/07/29 | Manufacturing Change or Addition | | 200327 | 009 | AP | 2013/05/29 | Labeling Revision | | 200327 | 008 | AP | 2012/10/23 | Labeling Revision | | 200327 | 007 | AP | 2012/05/03 | Manufacturing Change or Addition | | 200327 | 005 | AP | 2012/05/22 | Labeling Revision | | 200327 | 003 | AP | 2011/03/11 | Labeling Revision | | 200327 | 001 | AP | 2011/06/29 | Labeling Revision | | 200327 | 000 | AP | 2010/10/29 | Approval |
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