| 药品名称 | ONEXTON | | 申请号 | 050819 | 产品号 | 002 | | 活性成分 | BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | 市场状态 | 处方药 | | 剂型或给药途径 | GEL;TOPICAL | 规格 | 3.75%;EQ 1.2% BASE | | 治疗等效代码 | | 参比药物 | 是 | | 批准日期 | 2014/11/24 | 申请机构 | DOW PHARMACEUTICAL SCIENCES
| | 化学类型 | New formulation or new manufacturer | 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 | | 050819 | 012 | AP | Letter | 2014/11/26 | 下载 | | 050819 | 012 | AP | Label | 2014/11/26 | 下载 | | 050819 | 010 | AP | Label | 2014/03/04 | 下载 | | 050819 | 010 | AP | Letter | 2014/03/05 | 下载 | | 050819 | 003 | AP | Label | 2010/10/18 | 下载 | | 050819 | 003 | AP | Letter | 2010/10/20 | 下载 | | 050819 | 002 | AP | Letter | 2010/06/29 | 下载 | | 050819 | 002 | AP | Label | 2010/07/01 | 下载 | | 050819 | 000 | AP | Letter | 2008/10/29 | 下载 | | 050819 | 000 | AP | Label | 2008/11/07 | 下载 | | 050819 | 000 | AP | Review | 2009/10/29 | 下载 | | 050819 | 000 | AP | Summary Review | 2009/10/29 | 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 | | 050819 | 016 | AP | 2016/03/25 | Manufacturing Change or Addition | | 050819 | 015 | AP | 2015/10/08 | Manufacturing Change or Addition | | 050819 | 014 | AP | 2015/11/19 | Manufacturing Change or Addition | | 050819 | 013 | AP | 2015/09/10 | Manufacturing Change or Addition | | 050819 | 012 | AP | 2014/11/24 | Efficacy Supplement with Clinical Data to Support | | 050819 | 011 | AP | 2014/03/18 | Manufacturing Change or Addition | | 050819 | 010 | AP | 2014/02/28 | Labeling Revision | | 050819 | 009 | AP | 2012/12/18 | Manufacturing Change or Addition | | 050819 | 003 | AP | 2010/10/18 | Labeling Revision | | 050819 | 002 | AP | 2010/06/23 | Labeling Revision | | 050819 | 000 | AP | 2008/10/21 | Approval |
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