| 药品名称 | CLARITIN-D | | 申请号 | 019670 | 产品号 | 002 | | 活性成分 | LORATADINE; PSEUDOEPHEDRINE SULFATE | 市场状态 | 非处方药 | | 剂型或给药途径 | TABLET, EXTENDED RELEASE;ORAL | 规格 | 5MG;120MG | | 治疗等效代码 | | 参比药物 | 是 | | 批准日期 | 2002/11/27 | 申请机构 | BAYER HEALTHCARE 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 | | 019670 | 032 | AP | Letter | 2015/11/27 | 下载 | | 019670 | 032 | AP | Label | 2015/12/11 | 下载 | | 019670 | 022 | AP | Letter | 2010/02/17 | 下载 | | 019670 | 020 | AP | Review | 2011/12/16 | 下载 | | 019670 | 020 | AP | Letter | 2009/04/27 | 下载 | | 019670 | 019 | AP | Letter | 2004/08/02 | 下载 | | 019670 | 019 | AP | Label | 2004/08/02 | 下载 | | 019670 | 018 | AP | Review | 2004/12/07 | 下载 | | 019670 | 018 | AP | Letter | 2002/11/27 | 下载 | | 019670 | 017 | AP | Review | 2007/03/02 | 下载 | | 019670 | 015 | AP | Review | 2007/03/02 | 下载 | | 019670 | 014 | AP | Review | 2007/03/02 | 下载 | | 019670 | 013 | AP | Review | 2007/03/02 | 下载 | | 019670 | 012 | AP | Review | 2007/03/02 | 下载 | | 019670 | 009 | AP | Review | 2007/03/02 | 下载 | | 019670 | 008 | AP | Review | 2007/03/02 | 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 | | 019670 | 032 | AP | 2015/11/25 | Labeling Revision | | 019670 | 031 | AP | 2013/10/18 | Manufacturing Change or Addition | | 019670 | 030 | AP | 2013/03/13 | Manufacturing Change or Addition | | 019670 | 022 | AP | 2010/01/25 | Labeling Revision | | 019670 | 020 | AP | 2009/04/23 | Formulation Revision | | 019670 | 019 | AP | 2004/07/30 | New or Modified Indication | | 019670 | 018 | AP | 2002/11/27 | OTC Labeling | | 019670 | 017 | AP | 2002/03/04 | Expiration Date Change | | 019670 | 015 | AP | 2000/11/01 | Control Supplement | | 019670 | 014 | AP | 2000/03/22 | Control Supplement | | 019670 | 013 | AP | 2000/09/13 | Control Supplement | | 019670 | 012 | AP | 1998/10/29 | Manufacturing Change or Addition | | 019670 | 010 | AP | 1998/04/29 | Labeling Revision | | 019670 | 009 | AP | 1999/01/27 | Control Supplement | | 019670 | 008 | AP | 1998/01/23 | Manufacturing Change or Addition | | 019670 | 007 | AP | 1998/05/04 | Control Supplement | | 019670 | 006 | AP | 1997/07/14 | Labeling Revision | | 019670 | 005 | AP | 1997/07/21 | Control Supplement | | 019670 | 004 | AP | 1997/02/05 | Labeling Revision | | 019670 | 003 | AP | 1996/04/29 | Labeling Revision | | 019670 | 002 | AP | 1995/09/22 | Control Supplement | | 019670 | 001 | AP | 1997/02/07 | Control Supplement | | 019670 | 000 | AP | 1994/11/14 | Approval |
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