药品名称 | ENABLEX | 申请号 | 021513 | 产品号 | 001 | 活性成分 | DARIFENACIN HYDROBROMIDE | 市场状态 | 处方药 | 剂型或给药途径 | TABLET, EXTENDED RELEASE;ORAL | 规格 | EQ 7.5MG BASE | 治疗等效代码 | AB | 参比药物 | 否 | 批准日期 | 2004/12/22 | 申请机构 | ALLERGAN PHARMACEUTICALS INTERNATIONAL LTD
| 化学类型 | New molecular entity (NME) | 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 | NCE | 2009/12/22 |
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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 | 021513 | 010 | AP | Label | 2012/03/16 | 下载 | 021513 | 010 | AP | Letter | 2012/03/19 | 下载 | 021513 | 008 | AP | Letter | 2012/01/18 | 下载 | 021513 | 008 | AP | Label | 2012/01/26 | 下载 | 021513 | 007 | AP | Label | 2011/04/18 | 下载 | 021513 | 007 | AP | Letter | 2011/04/20 | 下载 | 021513 | 006 | AP | Label | 2010/10/19 | 下载 | 021513 | 006 | AP | Letter | 2010/10/25 | 下载 | 021513 | 005 | AP | Letter | 2008/12/19 | 下载 | 021513 | 005 | AP | Label | 2009/01/02 | 下载 | 021513 | 004 | AP | Letter | 2008/04/22 | 下载 | 021513 | 004 | AP | Label | 2008/06/05 | 下载 | 021513 | 002 | AP | Label | 2005/10/25 | 下载 | 021513 | 002 | AP | Letter | 2005/10/25 | 下载 | 021513 | 000 | AP | Letter | 2004/12/29 | 下载 | 021513 | 000 | AP | Label | 2004/12/29 | 下载 | 021513 | 000 | AP | Review | 2005/02/08 | 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 | 021513 | 015 | AP | 2016/01/13 | Manufacturing Change or Addition | 021513 | 014 | AP | 2015/12/18 | Manufacturing Change or Addition | 021513 | 013 | AP | 2013/09/20 | Manufacturing Change or Addition | 021513 | 012 | AP | 2013/08/09 | Manufacturing Change or Addition | 021513 | 011 | AP | 2013/04/03 | Manufacturing Change or Addition | 021513 | 010 | AP | 2012/03/15 | Labeling Revision | 021513 | 009 | AP | 2013/12/05 | Manufacturing Change or Addition | 021513 | 008 | AP | 2012/01/13 | Labeling Revision | 021513 | 007 | AP | 2011/04/18 | Labeling Revision | 021513 | 006 | AP | 2010/10/19 | Labeling Revision | 021513 | 005 | AP | 2008/12/12 | Labeling Revision | 021513 | 004 | AP | 2008/04/18 | Labeling Revision | 021513 | 002 | AP | 2005/10/20 | Manufacturing Change or Addition | 021513 | 000 | AP | 2004/12/22 | Approval |
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