药品名称 | DICLEGIS | 申请号 | 021876 | 产品号 | 001 | 活性成分 | DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE | 市场状态 | 处方药 | 剂型或给药途径 | TABLET, DELAYED RELEASE;ORAL | 规格 | 10MG;10MG | 治疗等效代码 | AB | 参比药物 | 是 | 批准日期 | 2013/04/08 | 申请机构 | DUCHESNAY INC
| 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 | NP | 2016/04/08 | 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 | 021876 | 006 | AP | Letter | 2014/12/17 | 下载 | 021876 | 002 | AP | Label | 2013/09/30 | 下载 | 021876 | 000 | AP | Review | 2014/03/25 | 下载 | 021876 | 000 | AP | Summary Review | 2014/03/25 | 下载 | 021876 | 000 | AP | Letter | 2013/04/10 | 下载 | 021876 | 000 | AP | Label | 2013/04/16 | 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 | 021876 | 009 | AP | 2016/03/10 | Manufacturing Change or Addition | 021876 | 008 | AP | 2015/09/10 | Manufacturing Change or Addition | 021876 | 007 | AP | 2015/06/23 | Manufacturing Change or Addition | 021876 | 006 | AP | 2014/12/16 | Labeling Revision | 021876 | 005 | AP | 2014/11/24 | Manufacturing Change or Addition | 021876 | 004 | AP | 2014/07/30 | Manufacturing Change or Addition | 021876 | 003 | AP | 2014/03/28 | Manufacturing Change or Addition | 021876 | 002 | AP | 2013/09/30 | Manufacturing Change or Addition | 021876 | 001 | AP | 2014/01/29 | Manufacturing Change or Addition | 021876 | 000 | AP | 2013/04/08 | Approval |
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