| 药品名称 | IMODIUM MULTI-SYMPTOM RELIEF | | 申请号 | 020606 | 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, CHEWABLE;ORAL | 规格 | 2MG;125MG | | 治疗等效代码 | | 参比药物 | 是 | | 批准日期 | 1996/06/26 | 申请机构 | JOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIVISION
| | 化学类型 | New combination | 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 | | 020606 | 014 | AP | Letter | 2008/05/05 | 下载 | | 020606 | 014 | AP | Summary Review | 2008/07/16 | 下载 | | 020606 | 009 | AP | Review | 2008/07/31 | 下载 | | 020606 | 009 | AP | Letter | 2004/06/16 | 下载 | | 020606 | 000 | AP | Review | 1997/06/25 | 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 | | 020606 | 014 | AP | 2008/04/30 | Efficacy Supplement with Clinical Data to Support | | 020606 | 009 | AP | 2004/06/16 | Labeling Revision | | 020606 | 008 | AP | 2001/06/21 | Control Supplement | | 020606 | 007 | AP | 1999/11/29 | Manufacturing Change or Addition | | 020606 | 006 | AP | 1999/12/03 | Manufacturing Change or Addition | | 020606 | 005 | AP | 1999/10/04 | Manufacturing Change or Addition | | 020606 | 004 | AP | 1998/10/14 | Manufacturing Change or Addition | | 020606 | 002 | AP | 1998/09/04 | Package Change | | 020606 | 001 | AP | 1998/09/10 | Control Supplement | | 020606 | 000 | AP | 1997/06/26 | Approval |
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