药品名称 | HYZAAR | 申请号 | 020387 | 产品号 | 003 | 活性成分 | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 市场状态 | 处方药 | 剂型或给药途径 | TABLET;ORAL | 规格 | 12.5MG;100MG | 治疗等效代码 | AB | 参比药物 | 否 | 批准日期 | 2005/10/20 | 申请机构 | MERCK SHARP AND DOHME CORP
| 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 | I-415 | 2006/09/30 |
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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 | 020387 | 060 | AP | Label | 2014/09/30 | 下载 | 020387 | 060 | AP | Letter | 2014/10/01 | 下载 | 020387 | 059 | AP | Letter | 2014/01/21 | 下载 | 020387 | 059 | AP | Label | 2014/01/22 | 下载 | 020387 | 057 | AP | Letter | 2013/03/29 | 下载 | 020387 | 057 | AP | Label | 2013/04/01 | 下载 | 020387 | 056 | AP | Label | 2012/10/02 | 下载 | 020387 | 056 | AP | Letter | 2012/10/03 | 下载 | 020387 | 055 | AP | Label | 2011/08/30 | 下载 | 020387 | 055 | AP | Letter | 2011/08/31 | 下载 | 020387 | 054 | AP | Letter | 2011/11/21 | 下载 | 020387 | 054 | AP | Label | 2011/11/21 | 下载 | 020387 | 052 | AP | Letter | 2011/08/18 | 下载 | 020387 | 052 | AP | Label | 2011/08/24 | 下载 | 020387 | 050 | AP | Letter | 2011/06/17 | 下载 | 020387 | 048 | AP | Label | 2010/09/23 | 下载 | 020387 | 048 | AP | Letter | 2010/09/27 | 下载 | 020387 | 047 | AP | Letter | 2015/12/15 | 下载 | 020387 | 047 | AP | Label | 2015/12/15 | 下载 | 020387 | 045 | AP | Letter | 2009/06/17 | 下载 | 020387 | 045 | AP | Label | 2009/06/22 | 下载 | 020387 | 041 | AP | Label | 2006/08/30 | 下载 | 020387 | 041 | AP | Letter | 2006/09/18 | 下载 | 020387 | 040 | AP | Letter | 2007/01/08 | 下载 | 020387 | 038 | AP | Label | 2006/04/21 | 下载 | 020387 | 038 | AP | Letter | 2006/04/25 | 下载 | 020387 | 037 | AP | Label | 2005/10/24 | 下载 | 020387 | 037 | AP | Letter | 2005/10/25 | 下载 | 020387 | 037 | AP | Review | 2011/02/15 | 下载 | 020387 | 035 | AP | Letter | 2005/04/13 | 下载 | 020387 | 035 | AP | Label | 2005/04/13 | 下载 | 020387 | 034 | AP | Label | 2005/04/13 | 下载 | 020387 | 034 | AP | Letter | 2005/04/13 | 下载 | 020387 | 033 | AP | Letter | 2005/04/12 | 下载 | 020387 | 033 | AP | Label | 2005/04/12 | 下载 | 020387 | 027 | AP | Review | 2003/11/25 | 下载 | 020387 | 027 | AP | Label | 2003/10/09 | 下载 | 020387 | 027 | AP | Letter | 2003/09/30 | 下载 | 020387 | 024 | AP | Letter | 2002/11/07 | 下载 | 020387 | 017 | AP | Review | 2000/01/19 | 下载 | 020387 | 015 | AP | Label | 2003/10/10 | 下载 | 020387 | 015 | AP | Letter | 2003/09/30 | 下载 | 020387 | 015 | AP | Review | 2003/11/25 | 下载 | 020387 | 014 | AP | Review | 2001/01/28 | 下载 | 020387 | 013 | AP | Review | 2003/11/25 | 下载 | 020387 | 013 | AP | Label | 2003/10/10 | 下载 | 020387 | 013 | AP | Letter | 2003/09/30 | 下载 | 020387 | 012 | AP | Review | 1999/06/09 | 下载 | 020387 | 011 | AP | Review | 1998/11/24 | 下载 | 020387 | 010 | AP | Review | 1998/08/25 | 下载 | 020387 | 008 | AP | Review | 1998/11/10 | 下载 | 020387 | 006 | AP | Review | 1998/08/24 | 下载 | 020387 | 005 | AP | Review | 1997/11/07 | 下载 | 020387 | 003 | AP | Review | 2002/04/30 | 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 | 020387 | 060 | AP | 2014/09/30 | Labeling Revision | 020387 | 059 | AP | 2014/01/17 | Labeling Revision | 020387 | 057 | AP | 2013/03/27 | Labeling Revision | 020387 | 056 | AP | 2012/09/28 | Labeling Revision | 020387 | 055 | AP | 2011/08/26 | Labeling Revision | 020387 | 054 | AP | 2011/11/17 | Labeling Revision | 020387 | 052 | AP | 2011/08/17 | Labeling Revision | 020387 | 050 | AP | 2011/06/10 | Labeling Revision | 020387 | 048 | AP | 2010/09/21 | Labeling Revision | 020387 | 047 | AP | 2015/12/11 | Labeling Revision | 020387 | 045 | AP | 2009/06/12 | Labeling Revision | 020387 | 041 | AP | 2006/08/29 | Labeling Revision | 020387 | 040 | AP | 2006/12/21 | Labeling Revision | 020387 | 038 | AP | 2006/04/20 | Labeling Revision | 020387 | 037 | AP | 2005/10/20 | New Dosage Regimen | 020387 | 035 | AP | 2005/04/12 | Labeling Revision | 020387 | 034 | AP | 2005/04/12 | Labeling Revision | 020387 | 033 | AP | 2005/04/05 | Efficacy Supplement with Clinical Data to Support | 020387 | 027 | AP | 2003/09/30 | New or Modified Indication | 020387 | 026 | AP | 2003/01/08 | Manufacturing Change or Addition | 020387 | 025 | AP | 2002/10/23 | Control Supplement | 020387 | 024 | AP | 2002/11/07 | Labeling Revision | 020387 | 023 | AP | 2002/01/10 | Manufacturing Change or Addition | 020387 | 022 | AP | 2001/08/24 | Labeling Revision | 020387 | 021 | AP | 2001/06/22 | Manufacturing Change or Addition | 020387 | 020 | AP | 2001/05/16 | Control Supplement | 020387 | 019 | AP | 2001/07/03 | Control Supplement | 020387 | 018 | AP | 2001/10/03 | Labeling Revision | 020387 | 017 | AP | 2000/01/19 | Labeling Revision | 020387 | 016 | AP | 2000/02/23 | Control Supplement | 020387 | 015 | AP | 2003/09/30 | Labeling Revision | 020387 | 014 | AP | 2000/01/28 | Labeling Revision | 020387 | 013 | AP | 2003/09/30 | Labeling Revision | 020387 | 012 | AP | 1999/06/09 | Labeling Revision | 020387 | 011 | AP | 1998/11/24 | Labeling Revision | 020387 | 010 | AP | 1998/08/25 | Labeling Revision | 020387 | 009 | AP | 1998/04/03 | Labeling Revision | 020387 | 008 | AP | 1998/11/10 | Formulation Revision | 020387 | 007 | AP | 1998/03/27 | Package Change | 020387 | 006 | AP | 1998/08/24 | Labeling Revision | 020387 | 005 | AP | 1997/11/07 | Labeling Revision | 020387 | 004 | AP | 1996/07/18 | Labeling Revision | 020387 | 003 | AP | 1995/12/01 | Manufacturing Change or Addition | 020387 | 002 | AP | 1995/11/22 | Labeling Revision | 020387 | 001 | AP | 1995/11/06 | Expiration Date Change | 020387 | 000 | AP | 1995/04/28 | Approval |
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