| 药品名称 | EOVIST | | 申请号 | 022090 | 产品号 | 001 | | 活性成分 | GADOXETATE DISODIUM | 市场状态 | 处方药 | | 剂型或给药途径 | SOLUTION;INTRAVENOUS | 规格 | 1.8143GM/10ML (181.43MG/ML) | | 治疗等效代码 | | 参比药物 | 是 | | 批准日期 | 2008/07/03 | 申请机构 | BAYER HEALTHCARE PHARMACEUTICALS 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 | | M-155 | 2018/03/27 | | 历史市场独占权保护信息 | | NCE | 2013/07/03 |
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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 | | 022090 | 011 | AP | Letter | 2015/04/01 | 下载 | | 022090 | 011 | AP | Label | 2015/04/01 | 下载 | | 022090 | 008 | AP | Letter | 2013/10/18 | 下载 | | 022090 | 008 | AP | Label | 2013/10/18 | 下载 | | 022090 | 005 | AP | Letter | 2011/11/21 | 下载 | | 022090 | 005 | AP | Label | 2011/11/21 | 下载 | | 022090 | 004 | AP | Label | 2010/12/20 | 下载 | | 022090 | 004 | AP | Letter | 2010/12/22 | 下载 | | 022090 | 002 | AP | Letter | 2009/11/19 | 下载 | | 022090 | 000 | AP | Other Important Information from FDA | 2011/12/21 | 下载 | | 022090 | 000 | AP | Label | 2008/07/09 | 下载 | | 022090 | 000 | AP | Letter | 2008/07/15 | 下载 | | 022090 | 000 | AP | Review | 2008/08/19 | 下载 | | 022090 | 000 | AP | Summary Review | 2008/08/19 | 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 | | 022090 | 012 | AP | 2015/10/26 | Manufacturing Change or Addition | | 022090 | 011 | AP | 2015/03/27 | Efficacy Supplement with Clinical Data to Support | | 022090 | 010 | AP | 2014/01/16 | Manufacturing Change or Addition | | 022090 | 008 | AP | 2013/10/16 | Labeling Revision | | 022090 | 005 | AP | 2011/11/16 | Labeling Revision | | 022090 | 004 | AP | 2010/12/20 | Labeling Revision | | 022090 | 003 | AP | 2013/02/04 | Manufacturing Change or Addition | | 022090 | 002 | AP | 2009/11/13 | Manufacturing Change or Addition | | 022090 | 000 | AP | 2008/07/03 | Approval |
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