药品名称 | SINGULAIR | 申请号 | 020829 | 产品号 | 002 | 活性成分 | MONTELUKAST SODIUM | 市场状态 | 处方药 | 剂型或给药途径 | TABLET;ORAL | 规格 | EQ 10MG BASE | 治疗等效代码 | AB | 参比药物 | 是 | 批准日期 | 1998/02/20 | 申请机构 | MERCK RESEARCH LABORATORIES DIV MERCK CO INC
| 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 | I-465 | 2008/08/27 | I-530 | 2010/04/13 | M-49 | 2008/11/30 | NPP | 2015/03/26 |
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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 | 020829 | 068 | AP | Letter | 2014/11/28 | 下载![](pdf.jpg) | 020829 | 068 | AP | Label | 2014/12/19 | 下载![](pdf.jpg) | 020829 | 066 | AP | Letter | 2013/12/31 | 下载![](pdf.jpg) | 020829 | 066 | AP | Label | 2013/12/31 | 下载![](pdf.jpg) | 020829 | 065 | AP | Letter | 2013/03/22 | 下载![](pdf.jpg) | 020829 | 065 | AP | Label | 2013/03/26 | 下载![](pdf.jpg) | 020829 | 063 | AP | Label | 2012/09/28 | 下载![](pdf.jpg) | 020829 | 063 | AP | Letter | 2012/10/02 | 下载![](pdf.jpg) | 020829 | 062 | AP | Letter | 2012/07/17 | 下载![](pdf.jpg) | 020829 | 062 | AP | Label | 2012/07/18 | 下载![](pdf.jpg) | 020829 | 061 | AP | Letter | 2012/10/22 | 下载![](pdf.jpg) | 020829 | 061 | AP | Label | 2012/10/22 | 下载![](pdf.jpg) | 020829 | 060 | AP | Label | 2011/12/20 | 下载![](pdf.jpg) | 020829 | 060 | AP | Letter | 2011/12/21 | 下载![](pdf.jpg) | 020829 | 059 | AP | Label | 2012/03/26 | 下载![](pdf.jpg) | 020829 | 059 | AP | Letter | 2012/03/28 | 下载![](pdf.jpg) | 020829 | 057 | AP | Label | 2011/04/29 | 下载![](pdf.jpg) | 020829 | 057 | AP | Letter | 2011/05/03 | 下载![](pdf.jpg) | 020829 | 055 | AP | Letter | 2010/08/16 | 下载![](pdf.jpg) | 020829 | 055 | AP | Label | 2010/08/19 | 下载![](pdf.jpg) | 020829 | 054 | AP | Letter | 2011/06/17 | 下载![](pdf.jpg) | 020829 | 052 | AP | Label | 2010/04/28 | 下载![](pdf.jpg) | 020829 | 052 | AP | Letter | 2010/04/29 | 下载![](pdf.jpg) | 020829 | 051 | AP | Label | 2009/09/15 | 下载![](pdf.jpg) | 020829 | 051 | AP | Letter | 2009/11/10 | 下载![](pdf.jpg) | 020829 | 049 | AP | Letter | 2009/01/30 | 下载![](pdf.jpg) | 020829 | 049 | AP | Label | 2009/02/04 | 下载![](pdf.jpg) | 020829 | 048 | AP | Letter | 2008/04/28 | 下载![](pdf.jpg) | 020829 | 048 | AP | Label | 2008/04/29 | 下载![](pdf.jpg) | 020829 | 047 | AP | Label | 2008/06/05 | 下载![](pdf.jpg) | 020829 | 047 | AP | Letter | 2008/04/22 | 下载![](pdf.jpg) | 020829 | 046 | AP | Letter | 2008/03/11 | 下载![](pdf.jpg) | 020829 | 046 | AP | Label | 2008/03/11 | 下载![](pdf.jpg) | 020829 | 043 | AP | Letter | 2007/04/20 | 下载![](pdf.jpg) | 020829 | 042 | AP | Letter | 2007/04/20 | 下载![](pdf.jpg) | 020829 | 041 | AP | Letter | 2007/04/20 | 下载![](pdf.jpg) | 020829 | 039 | AP | Label | 2006/12/14 | 下载![](pdf.jpg) | 020829 | 039 | AP | Letter | 2006/12/28 | 下载![](pdf.jpg) | 020829 | 038 | AP | Label | 2006/05/22 | 下载![](pdf.jpg) | 020829 | 038 | AP | Letter | 2006/05/22 | 下载![](pdf.jpg) | 020829 | 037 | AP | Letter | 2005/06/29 | 下载![](pdf.jpg) | 020829 | 037 | AP | Label | 2005/06/29 | 下载![](pdf.jpg) | 020829 | 036 | AP | Letter | 2007/04/20 | 下载![](pdf.jpg) | 020829 | 036 | AP | Label | 2007/04/20 | 下载![](pdf.jpg) | 020829 | 035 | AP | Letter | 2005/05/27 | 下载![](pdf.jpg) | 020829 | 035 | AP | Label | 2005/05/27 | 下载![](pdf.jpg) | 020829 | 034 | AP | Label | 2005/12/05 | 下载![](pdf.jpg) | 020829 | 034 | AP | Letter | 2005/12/06 | 下载![](pdf.jpg) | 020829 | 033 | AP | Label | 2005/07/29 | 下载![](pdf.jpg) | 020829 | 033 | AP | Letter | 2005/07/29 | 下载![](pdf.jpg) | 020829 | 033 | AP | Review | 2012/02/14 | 下载![](pdf.jpg) | 020829 | 032 | AP | Letter | 2005/01/11 | 下载![](pdf.jpg) | 020829 | 032 | AP | Label | 2005/01/11 | 下载![](pdf.jpg) | 020829 | 031 | AP | Letter | 2004/11/17 | 下载![](pdf.jpg) | 020829 | 031 | AP | Label | 2004/11/17 | 下载![](pdf.jpg) | 020829 | 026 | AP | Letter | 2003/12/23 | 下载![](pdf.jpg) | 020829 | 026 | AP | Label | 2003/12/29 | 下载![](pdf.jpg) | 020829 | 026 | AP | Review | 2007/07/06 | 下载![](pdf.jpg) | 020829 | 025 | AP | Review | 2007/07/06 | 下载![](pdf.jpg) | 020829 | 025 | AP | Label | 2003/11/13 | 下载![](pdf.jpg) | 020829 | 025 | AP | Letter | 2003/11/13 | 下载![](pdf.jpg) | 020829 | 023 | AP | Letter | 2003/10/09 | 下载![](pdf.jpg) | 020829 | 023 | AP | Label | 2003/10/10 | 下载![](pdf.jpg) | 020829 | 023 | AP | Review | 2007/07/09 | 下载![](pdf.jpg) | 020829 | 017 | AP | Label | 2003/04/07 | 下载![](pdf.jpg) | 020829 | 017 | AP | Letter | 2002/12/31 | 下载![](pdf.jpg) | 020829 | 012 | AP | Label | 2003/04/24 | 下载![](pdf.jpg) | 020829 | 001 | AP | Review | 2001/07/05 | 下载![](pdf.jpg) | 020829 | 000 | AP | Letter | 1998/02/20 | 下载![](pdf.jpg) | 020829 | 000 | AP | Label | 1998/02/20 | 下载![](pdf.jpg) | 020829 | 000 | AP | Review | 1998/02/20 | 下载 | 020829 | 000 | AP | Other Important Information from FDA | 2008/08/12 | 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 | 020829 | 068 | AP | 2014/11/26 | Labeling Revision | 020829 | 067 | AP | 2014/01/28 | Manufacturing Change or Addition | 020829 | 066 | AP | 2013/12/30 | Labeling Revision | 020829 | 065 | AP | 2013/03/21 | Labeling Revision | 020829 | 063 | AP | 2012/09/27 | Labeling Revision | 020829 | 062 | AP | 2012/07/16 | Labeling Revision | 020829 | 061 | AP | 2012/10/18 | Labeling Revision | 020829 | 060 | AP | 2011/12/16 | Labeling Revision | 020829 | 059 | AP | 2012/03/26 | New or Modified Indication | 020829 | 057 | AP | 2011/04/27 | Labeling Revision | 020829 | 055 | AP | 2010/08/10 | Labeling Revision | 020829 | 054 | AP | 2011/06/10 | Labeling Revision | 020829 | 052 | AP | 2010/04/26 | Labeling Revision | 020829 | 051 | AP | 2009/08/19 | Labeling Revision | 020829 | 049 | AP | 2009/01/27 | Labeling Revision | 020829 | 048 | AP | 2008/04/23 | Labeling Revision | 020829 | 047 | AP | 2008/04/21 | Labeling Revision | 020829 | 046 | AP | 2008/03/07 | Labeling Revision | 020829 | 043 | AP | 2007/04/13 | Labeling Revision | 020829 | 042 | AP | 2007/04/13 | Labeling Revision | 020829 | 041 | AP | 2007/04/13 | Labeling Revision | 020829 | 039 | AP | 2006/12/08 | Labeling Revision | 020829 | 038 | AP | 2006/05/19 | Labeling Revision | 020829 | 037 | AP | 2005/06/27 | Labeling Revision | 020829 | 036 | AP | 2007/04/13 | New or Modified Indication | 020829 | 035 | AP | 2005/05/26 | Labeling Revision | 020829 | 034 | AP | 2005/11/30 | Efficacy Supplement with Clinical Data to Support | 020829 | 033 | AP | 2005/07/27 | New or Modified Indication | 020829 | 032 | AP | 2004/12/29 | Labeling Revision | 020829 | 031 | AP | 2004/11/15 | Labeling Revision | 020829 | 029 | AP | 2004/11/15 | Labeling Revision | 020829 | 026 | AP | 2003/12/19 | Labeling Revision | 020829 | 025 | AP | 2003/11/05 | Labeling Revision | 020829 | 023 | AP | 2003/10/02 | Labeling Revision | 020829 | 019 | AP | 2002/10/07 | Package Change | 020829 | 018 | AP | 2002/07/11 | Control Supplement | 020829 | 017 | AP | 2002/12/31 | New or Modified Indication | 020829 | 016 | AP | 2002/02/11 | Manufacturing Change or Addition | 020829 | 014 | AP | 2001/10/26 | Labeling Revision | 020829 | 013 | AP | 2001/06/18 | Control Supplement | 020829 | 012 | AP | 2001/08/02 | Labeling Revision | 020829 | 010 | AP | 2000/09/05 | Control Supplement | 020829 | 009 | AP | 2000/10/17 | Labeling Revision | 020829 | 007 | AP | 1999/07/28 | Control Supplement | 020829 | 006 | AP | 1998/12/01 | Labeling Revision | 020829 | 005 | AP | 1999/01/21 | Manufacturing Change or Addition | 020829 | 004 | AP | 1998/09/18 | Labeling Revision | 020829 | 003 | AP | 1998/04/30 | Labeling Revision | 020829 | 002 | AP | 1998/04/02 | Labeling Revision | 020829 | 001 | AP | 1999/02/12 | Labeling Revision | 020829 | 000 | AP | 1998/02/20 | Approval |
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