药品名称 | ACCUPRIL | 申请号 | 019885 | 产品号 | 002 | 活性成分 | QUINAPRIL HYDROCHLORIDE | 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 | 否 | 批准日期 | 1991/11/19 | 申请机构 | PFIZER PHARMACEUTICALS 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 | 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 | 019885 | 041 | AP | Letter | 2015/09/14 | 下载 | 019885 | 041 | AP | Label | 2015/09/14 | 下载 | 019885 | 040 | AP | Letter | 2014/05/06 | 下载 | 019885 | 040 | AP | Label | 2014/05/06 | 下载 | 019885 | 039 | AP | Letter | 2013/10/28 | 下载 | 019885 | 039 | AP | Label | 2013/10/31 | 下载 | 019885 | 038 | AP | Label | 2013/09/23 | 下载 | 019885 | 038 | AP | Letter | 2013/09/24 | 下载 | 019885 | 037 | AP | Letter | 2013/04/11 | 下载 | 019885 | 037 | AP | Label | 2013/04/16 | 下载 | 019885 | 036 | AP | Label | 2012/09/25 | 下载 | 019885 | 035 | AP | Letter | 2012/01/23 | 下载 | 019885 | 035 | AP | Label | 2012/01/23 | 下载 | 019885 | 033 | AP | Letter | 2011/10/18 | 下载 | 019885 | 033 | AP | Label | 2011/10/20 | 下载 | 019885 | 028 | AP | Label | 2009/10/01 | 下载 | 019885 | 028 | AP | Letter | 2009/11/12 | 下载 | 019885 | 023 | AP | Letter | 2003/11/05 | 下载 | 019885 | 019 | AP | Letter | 2003/07/30 | 下载 | 019885 | 018 | AP | Letter | 2001/04/17 | 下载 | 019885 | 000 | AP | Other Important Information from FDA | 2006/06/09 | 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 | 019885 | 041 | AP | 2015/09/11 | Labeling Revision | 019885 | 040 | AP | 2014/05/02 | Labeling Revision | 019885 | 039 | AP | 2013/10/25 | Labeling Revision | 019885 | 038 | AP | 2013/09/23 | Labeling Revision | 019885 | 037 | AP | 2013/04/09 | Labeling Revision | 019885 | 036 | AP | 2012/09/21 | Labeling Revision | 019885 | 035 | AP | 2012/01/18 | Labeling Revision | 019885 | 033 | AP | 2011/10/14 | Labeling Revision | 019885 | 028 | AP | 2009/09/18 | Labeling Revision | 019885 | 023 | AP | 2003/10/29 | Labeling Revision | 019885 | 022 | AP | 2002/12/13 | Control Supplement | 019885 | 020 | AP | 2001/06/21 | Labeling Revision | 019885 | 019 | AP | 2002/07/22 | Labeling Revision | 019885 | 018 | AP | 2001/04/17 | Labeling Revision | 019885 | 017 | AP | 1999/09/10 | Manufacturing Change or Addition | 019885 | 016 | AP | 1998/05/04 | Control Supplement | 019885 | 015 | AP | 1998/02/25 | Labeling Revision | 019885 | 014 | AP | 1997/07/03 | Control Supplement | 019885 | 013 | AP | 1997/07/02 | Manufacturing Change or Addition | 019885 | 012 | AP | 1997/07/01 | Manufacturing Change or Addition | 019885 | 011 | AP | 1996/07/03 | Labeling Revision | 019885 | 010 | AP | 1996/06/18 | Manufacturing Change or Addition | 019885 | 009 | AP | 1995/11/02 | Control Supplement | 019885 | 008 | AP | 1995/11/01 | Control Supplement | 019885 | 007 | AP | 1995/11/20 | Manufacturing Change or Addition | 019885 | 006 | AP | 1996/04/12 | Labeling Revision | 019885 | 004 | AP | 1993/05/26 | Labeling Revision | 019885 | 003 | AP | 1994/10/12 | Labeling Revision | 019885 | 002 | AP | 1992/05/07 | Labeling Revision | 019885 | 001 | AP | 1993/10/29 | New or Modified Indication | 019885 | 000 | AP | 1991/11/19 | Approval |
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