| 药品名称 | CHILDREN'S MOTRIN | | 申请号 | 020516 | 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 | 是 | | 批准日期 | 1995/06/16 | 申请机构 | JOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIVISION
| | 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 | | 020516 | 033 | AP | Letter | 2016/06/21 | 下载 | | 020516 | 033 | AP | Label | 2016/06/22 | 下载 | | 020516 | 030 | AP | Letter | 2015/04/17 | 下载 | | 020516 | 030 | AP | Label | 2015/04/21 | 下载 | | 020516 | 029 | AP | Letter | 2014/12/12 | 下载 | | 020516 | 029 | AP | Label | 2014/12/19 | 下载 | | 020516 | 024 | AP | Letter | 2011/12/08 | 下载 | | 020516 | 022 | AP | Letter | 2010/10/22 | 下载 | | 020516 | 021 | AP | Letter | 2009/05/06 | 下载 | | 020516 | 020 | AP | Letter | 2006/06/28 | 下载 | | 020516 | 018 | AP | Letter | 2005/12/15 | 下载 | | 020516 | 016 | AP | Letter | 2005/02/09 | 下载 | | 020516 | 012 | AP | Letter | 2003/12/23 | 下载 | | 020516 | 011 | AP | Letter | 2003/10/31 | 下载 | | 020516 | 004 | AP | Letter | 1999/09/13 | 下载 | | 020516 | 004 | AP | Label | 1999/09/13 | 下载 | | 020516 | 004 | AP | Review | 1999/09/13 | 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 | | 020516 | 033 | AP | 2016/06/16 | Labeling Revision | | 020516 | 032 | AP | 2016/06/17 | Manufacturing Change or Addition | | 020516 | 031 | AP | 2015/12/07 | Manufacturing Change or Addition | | 020516 | 030 | AP | 2015/04/16 | Labeling Revision | | 020516 | 029 | AP | 2014/12/11 | Labeling Revision | | 020516 | 028 | AP | 2012/11/19 | Manufacturing Change or Addition | | 020516 | 026 | AP | 2012/08/12 | Manufacturing Change or Addition | | 020516 | 024 | AP | 2011/12/06 | Labeling Revision | | 020516 | 022 | AP | 2010/10/19 | Labeling Revision | | 020516 | 021 | AP | 2009/04/29 | Labeling Revision | | 020516 | 020 | AP | 2006/06/22 | Control Supplement | | 020516 | 018 | AP | 2005/12/07 | Labeling Revision | | 020516 | 016 | AP | 2005/02/07 | Formulation Revision | | 020516 | 012 | AP | 2003/12/19 | Labeling Revision | | 020516 | 011 | AP | 2003/10/28 | Labeling Revision | | 020516 | 008 | AP | 2001/05/02 | Control Supplement | | 020516 | 007 | AP | 2000/07/18 | Control Supplement | | 020516 | 006 | AP | 2000/10/02 | Labeling Revision | | 020516 | 004 | AP | 1999/09/13 | Labeling Revision | | 020516 | 003 | AP | 1998/12/18 | Formulation Revision | | 020516 | 002 | AP | 1998/06/04 | Labeling Revision | | 020516 | 001 | AP | 1997/03/31 | Labeling Revision | | 020516 | 000 | AP | 1995/06/16 | Approval |
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