| 药品名称 | TYLENOL | | 申请号 | 019872 | 产品号 | 002 | | 活性成分 | ACETAMINOPHEN | 市场状态 | 非处方药 | | 剂型或给药途径 | TABLET, EXTENDED RELEASE;ORAL | 规格 | 650MG | | 治疗等效代码 | | 参比药物 | 是 | | 批准日期 | 2001/01/11 | 申请机构 | JOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIVISION
| | 化学类型 | New dosage form | 审评分类 | Standard review drug |
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| 与本品相关的专利信息（来自橙皮书Orange Book） | | 专利号 | 专利过期日 | 是否化合物专利 | 是否产品专利 | 专利用途代码 | 专利下载 | | 无 | | 历史专利信息 | | 无 |
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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 | | 019872 | 044 | AP | Label | 2016/08/30 | 下载 | | 019872 | 044 | AP | Letter | 2016/08/30 | 下载 | | 019872 | 042 | AP | Letter | 2014/12/30 | 下载 | | 019872 | 042 | AP | Label | 2015/01/05 | 下载 | | 019872 | 041 | AP | Letter | 2014/12/15 | 下载 | | 019872 | 041 | AP | Label | 2014/12/15 | 下载 | | 019872 | 040 | AP | Letter | 2014/03/07 | 下载 | | 019872 | 040 | AP | Label | 2014/03/27 | 下载 | | 019872 | 039 | AP | Label | 2014/01/09 | 下载 | | 019872 | 039 | AP | Letter | 2013/12/26 | 下载 | | 019872 | 037 | AP | Letter | 2013/03/28 | 下载 | | 019872 | 037 | AP | Label | 2014/01/09 | 下载 | | 019872 | 036 | AP | Label | 2014/01/09 | 下载 | | 019872 | 036 | AP | Letter | 2012/01/03 | 下载 | | 019872 | 034 | AP | Letter | 2010/05/17 | 下载 | | 019872 | 033 | AP | Letter | 2010/05/12 | 下载 | | 019872 | 031 | AP | Letter | 2009/06/23 | 下载 | | 019872 | 031 | AP | Label | 2009/06/29 | 下载 | | 019872 | 029 | AP | Review | 2012/01/27 | 下载 | | 019872 | 021 | AP | Letter | 2004/11/08 | 下载 | | 019872 | 018 | AP | Letter | 2004/04/20 | 下载 | | 019872 | 017 | AP | Letter | 2004/03/30 | 下载 | | 019872 | 016 | AP | Letter | 2003/08/14 | 下载 | | 019872 | 014 | AP | Label | 2003/06/08 | 下载 | | 019872 | 014 | AP | Letter | 2003/06/08 | 下载 | | 019872 | 013 | AP | Letter | 2003/06/08 | 下载 | | 019872 | 013 | AP | Label | 2003/06/08 | 下载 | | 019872 | 012 | AP | Letter | 2003/06/08 | 下载 | | 019872 | 012 | AP | Label | 2003/06/08 | 下载 | | 019872 | 009 | AP | Review | 2012/06/28 | 下载 | | 019872 | 006 | AP | Review | 2012/04/13 | 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 | | 019872 | 045 | AP | 2016/08/15 | Manufacturing Change or Addition | | 019872 | 044 | AP | 2016/08/26 | Labeling Revision | | 019872 | 043 | AP | 2016/05/05 | Manufacturing Change or Addition | | 019872 | 042 | AP | 2014/12/23 | Labeling Revision | | 019872 | 041 | AP | 2014/12/12 | Labeling Revision | | 019872 | 040 | AP | 2014/03/06 | Labeling Revision | | 019872 | 039 | AP | 2013/12/20 | Labeling Revision | | 019872 | 038 | AP | 2013/03/28 | Manufacturing Change or Addition | | 019872 | 037 | AP | 2013/03/26 | Labeling Revision | | 019872 | 036 | AP | 2011/12/23 | Labeling Revision | | 019872 | 034 | AP | 2010/05/10 | Manufacturing Change or Addition | | 019872 | 033 | AP | 2010/05/06 | Labeling Revision | | 019872 | 031 | AP | 2009/06/17 | Labeling Revision | | 019872 | 029 | AP | 2008/02/28 | Labeling Revision | | 019872 | 021 | AP | 2004/11/03 | Package Change | | 019872 | 018 | AP | 2004/04/13 | Labeling Revision | | 019872 | 017 | AP | 2004/03/22 | Package Change | | 019872 | 016 | AP | 2003/08/01 | Control Supplement | | 019872 | 014 | AP | 2003/05/28 | Labeling Revision | | 019872 | 013 | AP | 2003/05/28 | Labeling Revision | | 019872 | 012 | AP | 2003/05/29 | Labeling Revision | | 019872 | 011 | AP | 2001/02/12 | Manufacturing Change or Addition | | 019872 | 010 | AP | 2000/07/25 | Package Change | | 019872 | 009 | AP | 2000/07/25 | Labeling Revision | | 019872 | 006 | AP | 2001/01/11 | Formulation Revision | | 019872 | 005 | AP | 1995/08/01 | Control Supplement | | 019872 | 003 | AP | 1995/01/05 | Control Supplement | | 019872 | 002 | AP | 1995/07/28 | Package Change | | 019872 | 001 | AP | 1994/11/23 | Package Change | | 019872 | 000 | AP | 1994/06/08 | Approval |
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