| 药品名称 | CHILDREN'S ADVIL | | 申请号 | 020589 | 产品号 | 001 | | 活性成分 | IBUPROFEN | 市场状态 | 非处方药 | | 剂型或给药途径 | SUSPENSION;ORAL | 规格 | 100MG/5ML | | 治疗等效代码 | | 参比药物 | 否 | | 批准日期 | 1996/06/27 | 申请机构 | PFIZER INC
| | 化学类型 | OTC (over-the-counter) switch | 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 | | 020589 | 029 | AP | Letter | 2013/12/24 | 下载 | | 020589 | 029 | AP | Label | 2014/01/13 | 下载 | | 020589 | 026 | AP | Letter | 2010/09/07 | 下载 | | 020589 | 024 | AP | Letter | 2009/05/26 | 下载 | | 020589 | 023 | AP | Letter | 2008/06/16 | 下载 | | 020589 | 019 | AP | Letter | 2005/12/15 | 下载 | | 020589 | 017 | AP | Letter | 2005/03/23 | 下载 | | 020589 | 017 | AP | Label | 2005/03/23 | 下载 | | 020589 | 013 | AP | Label | 2003/04/25 | 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 | | 020589 | 033 | AP | 2016/07/28 | Manufacturing Change or Addition | | 020589 | 032 | AP | 2013/06/12 | Manufacturing Change or Addition | | 020589 | 031 | AP | 2012/12/07 | Manufacturing Change or Addition | | 020589 | 030 | AP | 2012/09/04 | Manufacturing Change or Addition | | 020589 | 029 | AP | 2013/12/20 | Manufacturing Change or Addition | | 020589 | 026 | AP | 2010/09/02 | Labeling Revision | | 020589 | 024 | AP | 2009/05/19 | Labeling Revision | | 020589 | 023 | AP | 2008/06/11 | Labeling Revision | | 020589 | 019 | AP | 2005/12/07 | Labeling Revision | | 020589 | 017 | AP | 2005/03/18 | Labeling Revision | | 020589 | 015 | AP | 2002/11/14 | Labeling Revision | | 020589 | 014 | AP | 2001/08/02 | Control Supplement | | 020589 | 013 | AP | 2001/08/02 | Formulation Revision | | 020589 | 012 | AP | 2001/09/17 | Control Supplement | | 020589 | 011 | AP | 2000/07/14 | Package Change | | 020589 | 010 | AP | 2000/03/30 | Control Supplement | | 020589 | 009 | AP | 2000/08/25 | Labeling Revision | | 020589 | 008 | AP | 1999/10/17 | Package Change | | 020589 | 006 | AP | 1998/10/14 | Manufacturing Change or Addition | | 020589 | 004 | AP | 1998/05/05 | Manufacturing Change or Addition | | 020589 | 001 | AP | 1997/11/07 | Formulation Revision | | 020589 | 000 | AP | 1996/06/27 | Approval |
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