| 药品名称 | MUCINEX | | 申请号 | 021282 | 产品号 | 001 | | 活性成分 | GUAIFENESIN | 市场状态 | 非处方药 | | 剂型或给药途径 | TABLET, EXTENDED RELEASE;ORAL | 规格 | 600MG | | 治疗等效代码 | | 参比药物 | 否 | | 批准日期 | 2002/07/12 | 申请机构 | RECKITT BENCKISER LLC
| | 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 | | 021282 | 037 | AP | Letter | 2014/03/07 | 下载 | | 021282 | 035 | AP | Letter | 2014/03/07 | 下载 | | 021282 | 029 | AP | Letter | 2009/04/07 | 下载 | | 021282 | 025 | AP | Letter | 2008/08/22 | 下载 | | 021282 | 021 | AP | Label | 2007/09/07 | 下载 | | 021282 | 021 | AP | Letter | 2007/09/07 | 下载 | | 021282 | 016 | AP | Letter | 2006/11/22 | 下载 | | 021282 | 011 | AP | Letter | 2006/09/18 | 下载 | | 021282 | 001 | AP | Letter | 2002/12/18 | 下载 | | 021282 | 000 | AP | Letter | 2002/07/12 | 下载 | | 021282 | 000 | AP | Label | 2002/07/12 | 下载 | | 021282 | 000 | AP | Review | 2002/11/25 | 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 | | 021282 | 047 | AP | 2016/10/05 | Manufacturing Change or Addition | | 021282 | 046 | AP | 2015/10/19 | Manufacturing Change or Addition | | 021282 | 045 | AP | 2015/03/09 | Manufacturing Change or Addition | | 021282 | 044 | AP | 2014/09/10 | Manufacturing Change or Addition | | 021282 | 043 | AP | 2014/05/22 | Manufacturing Change or Addition | | 021282 | 037 | AP | 2011/05/12 | Manufacturing Change or Addition | | 021282 | 035 | AP | 2011/03/11 | Manufacturing Change or Addition | | 021282 | 029 | AP | 2009/04/03 | Control Supplement | | 021282 | 025 | AP | 2008/08/20 | Package Change | | 021282 | 021 | AP | 2007/09/06 | Formulation Revision | | 021282 | 016 | AP | 2006/11/14 | Labeling Revision | | 021282 | 011 | AP | 2006/08/23 | Package Change | | 021282 | 001 | AP | 2002/12/18 | Formulation Revision | | 021282 | 000 | AP | 2002/07/12 | Approval |
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