| 药品名称 | IMODIUM MULTI-SYMPTOM RELIEF | | 申请号 | 021140 | 产品号 | 001 | | 活性成分 | LOPERAMIDE HYDROCHLORIDE; SIMETHICONE | 市场状态 | 非处方药 | | 剂型或给药途径 | TABLET;ORAL | 规格 | 2MG;125MG | | 治疗等效代码 | | 参比药物 | 是 | | 批准日期 | 2000/11/30 | 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 | | 021140 | 020 | AP | Letter | 2015/03/19 | 下载 | | 021140 | 020 | AP | Label | 2015/03/24 | 下载 | | 021140 | 016 | AP | Letter | 2012/05/08 | 下载 | | 021140 | 013 | AP | Letter | 2008/02/07 | 下载 | | 021140 | 012 | AP | Label | 2007/09/19 | 下载 | | 021140 | 012 | AP | Letter | 2007/09/25 | 下载 | | 021140 | 011 | AP | Letter | 2008/05/05 | 下载 | | 021140 | 011 | AP | Summary Review | 2008/07/16 | 下载 | | 021140 | 003 | AP | Review | 2008/07/31 | 下载 | | 021140 | 003 | AP | Letter | 2004/06/16 | 下载 | | 021140 | 002 | AP | Letter | 2004/06/07 | 下载 | | 021140 | 002 | AP | Label | 2004/06/07 | 下载 | | 021140 | 000 | AP | Letter | 2000/11/29 | 下载 | | 021140 | 000 | AP | Label | 2000/11/29 | 下载 | | 021140 | 000 | AP | Review | 2000/01/29 | 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 | | 021140 | 024 | AP | 2015/12/02 | Manufacturing Change or Addition | | 021140 | 023 | AP | 2015/09/01 | Manufacturing Change or Addition | | 021140 | 022 | AP | 2015/08/03 | Manufacturing Change or Addition | | 021140 | 021 | AP | 2015/02/03 | Manufacturing Change or Addition | | 021140 | 020 | AP | 2015/03/18 | Labeling Revision | | 021140 | 019 | AP | 2015/08/07 | Manufacturing Change or Addition | | 021140 | 016 | AP | 2012/05/03 | Labeling Revision | | 021140 | 013 | AP | 2008/02/05 | Labeling Revision | | 021140 | 012 | AP | 2007/09/14 | Formulation Revision | | 021140 | 011 | AP | 2008/04/30 | Efficacy Supplement with Clinical Data to Support | | 021140 | 003 | AP | 2004/06/16 | Labeling Revision | | 021140 | 002 | AP | 2003/01/27 | Labeling Revision | | 021140 | 001 | AP | 2001/09/12 | Control Supplement | | 021140 | 000 | AP | 2000/11/30 | Approval |
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