| 药品名称 | VISIPAQUE 320 | | 申请号 | 020351 | 产品号 | 002 | | 活性成分 | IODIXANOL | 市场状态 | 处方药 | | 剂型或给药途径 | INJECTABLE;INJECTION | 规格 | 65.2% | | 治疗等效代码 | | 参比药物 | 是 | | 批准日期 | 1996/03/22 | 申请机构 | GE HEALTHCARE
| | 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 | | 无 | | 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 | | 020351 | 043 | AP | Label | 2015/07/09 | 下载 | | 020351 | 043 | AP | Letter | 2015/07/10 | 下载 | | 020351 | 021 | AP | Letter | 2005/08/31 | 下载 | | 020351 | 020 | AP | Letter | 2005/04/28 | 下载 | | 020351 | 018 | AP | Letter | 2005/01/11 | 下载 | | 020351 | 016 | AP | Letter | 2004/03/28 | 下载 | | 020351 | 013 | AP | Letter | 2003/12/23 | 下载 | | 020351 | 013 | AP | Label | 2003/12/29 | 下载 | | 020351 | 011 | AP | Letter | 2003/09/25 | 下载 | | 020351 | 010 | AP | Letter | 2004/06/30 | 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 | | 020351 | 043 | AP | 2015/07/06 | Labeling Revision | | 020351 | 041 | AP | 2013/11/20 | Manufacturing Change or Addition | | 020351 | 040 | AP | 2013/09/12 | Manufacturing Change or Addition | | 020351 | 021 | AP | 2005/08/25 | Package Change | | 020351 | 020 | AP | 2005/04/20 | Manufacturing Change or Addition | | 020351 | 018 | AP | 2004/12/30 | Labeling Revision | | 020351 | 016 | AP | 2004/03/24 | Package Change | | 020351 | 013 | AP | 2003/12/18 | Labeling Revision | | 020351 | 011 | AP | 2003/09/04 | Package Change | | 020351 | 010 | AP | 2002/12/03 | Manufacturing Change or Addition | | 020351 | 009 | AP | 2002/05/01 | Control Supplement | | 020351 | 008 | AP | 2002/06/05 | Control Supplement | | 020351 | 007 | AP | 2001/11/05 | Control Supplement | | 020351 | 006 | AP | 2001/10/11 | Manufacturing Change or Addition | | 020351 | 004 | AP | 1998/09/08 | Control Supplement | | 020351 | 003 | AP | 1997/10/10 | New or Modified Indication | | 020351 | 001 | AP | 1997/10/10 | Labeling Revision | | 020351 | 000 | AP | 1996/03/22 | Approval |
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