| 药品名称 | ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION | | 申请号 | 020786 | 产品号 | 002 | | 活性成分 | FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | 市场状态 | 非处方药 | | 剂型或给药途径 | TABLET, EXTENDED RELEASE;ORAL | 规格 | 60MG;120MG | | 治疗等效代码 | | 参比药物 | 是 | | 批准日期 | 2011/01/24 | 申请机构 | SANOFI AVENTIS US LLC
| | 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 | | 020786 | 035 | AP | Letter | 2016/06/07 | 下载 | | 020786 | 035 | AP | Label | 2016/06/10 | 下载 | | 020786 | 033 | AP | Letter | 2015/06/10 | 下载 | | 020786 | 033 | AP | Label | 2015/06/19 | 下载 | | 020786 | 031 | AP | Letter | 2012/12/11 | 下载 | | 020786 | 031 | AP | Label | 2013/01/08 | 下载 | | 020786 | 029 | AP | Letter | 2012/08/27 | 下载 | | 020786 | 029 | AP | Label | 2012/10/12 | 下载 | | 020786 | 028 | AP | Letter | 2012/02/13 | 下载 | | 020786 | 027 | AP | Label | 2012/03/27 | 下载 | | 020786 | 027 | AP | Letter | 2011/01/27 | 下载 | | 020786 | 026 | AP | Letter | 2010/04/19 | 下载 | | 020786 | 026 | AP | Label | 2010/04/19 | 下载 | | 020786 | 014 | AP | Label | 2003/05/29 | 下载 | | 020786 | 014 | AP | Letter | 2003/06/08 | 下载 | | 020786 | 012 | AP | Review | 2007/08/06 | 下载 | | 020786 | 012 | AP | Letter | 2002/11/01 | 下载 | | 020786 | 009 | AP | Review | 2008/08/04 | 下载 | | 020786 | 006 | AP | Review | 2008/08/04 | 下载 | | 020786 | 005 | AP | Review | 2008/08/08 | 下载 | | 020786 | 004 | AP | Review | 2008/08/04 | 下载 | | 020786 | 003 | AP | Review | 2008/08/08 | 下载 | | 020786 | 002 | AP | Review | 2008/08/08 | 下载 | | 020786 | 001 | AP | Review | 2008/08/08 | 下载 | | 020786 | 000 | AP | Review | 2010/05/25 | 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 | | 020786 | 035 | AP | 2016/06/02 | Labeling Revision | | 020786 | 034 | AP | 2015/07/09 | Manufacturing Change or Addition | | 020786 | 033 | AP | 2015/06/08 | Efficacy Supplement with Clinical Data to Support | | 020786 | 032 | AP | 2014/05/14 | Manufacturing Change or Addition | | 020786 | 031 | AP | 2012/12/05 | Labeling Revision | | 020786 | 029 | AP | 2012/08/23 | Labeling Revision | | 020786 | 028 | AP | 2012/02/03 | Manufacturing Change or Addition | | 020786 | 027 | AP | 2011/01/24 | OTC Labeling | | 020786 | 026 | AP | 2010/04/14 | Labeling Revision | | 020786 | 017 | AP | 2004/12/06 | Labeling Revision | | 020786 | 014 | AP | 2003/05/12 | Efficacy Supplement with Clinical Data to Support | | 020786 | 013 | AP | 2001/10/31 | Control Supplement | | 020786 | 012 | AP | 2002/11/01 | Labeling Revision | | 020786 | 011 | AP | 2002/10/29 | Manufacturing Change or Addition | | 020786 | 009 | AP | 2001/01/19 | Control Supplement | | 020786 | 008 | AP | 2000/09/26 | Package Change | | 020786 | 006 | AP | 2000/01/06 | Manufacturing Change or Addition | | 020786 | 005 | AP | 1999/12/01 | Control Supplement | | 020786 | 004 | AP | 2000/01/21 | Control Supplement | | 020786 | 003 | AP | 1998/12/22 | Labeling Revision | | 020786 | 002 | AP | 1999/12/21 | Control Supplement | | 020786 | 001 | AP | 1998/07/06 | Manufacturing Change or Addition | | 020786 | 000 | AP | 1997/12/24 | Approval |
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