| 药品名称 | BREVIBLOC | | 申请号 | 019386 | 产品号 | 002 | | 活性成分 | ESMOLOL HYDROCHLORIDE | 市场状态 | 停止上市 | | 剂型或给药途径 | INJECTABLE; INJECTION | 规格 | 250MG/ML | | 治疗等效代码 | | 参比药物 | 否 | | 批准日期 | | 申请机构 | BAXTER HLTHCARE | | 化学类型 | New molecular entity (NME) | 审评分类 | Priority review drug |
|
|
|
| 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 |
|
| 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 | | 019386 | 043 | AP | Label | 2012/12/13 | 下载 | | 019386 | 043 | AP | Letter | 2012/12/13 | 下载 | | 019386 | 039 | AP | Label | 2007/11/07 | 下载 | | 019386 | 039 | AP | Letter | 2007/11/08 | 下载 | | 019386 | 024 | AP | Letter | 2003/08/26 | 下载 | | 019386 | 022 | AP | Review | 2007/07/06 | 下载 | | 019386 | 022 | AP | Letter | 2003/05/30 | 下载 | | 019386 | 021 | AP | Review | 2003/07/08 | 下载 | | 019386 | 021 | AP | Letter | 2003/03/10 | 下载 | | 019386 | 020 | AP | Letter | 2003/01/27 | 下载 | | 019386 | 019 | AP | Letter | 2003/01/27 | 下载 | | 019386 | 018 | AP | Review | 2007/09/14 | 下载 | | 019386 | 017 | AP | Review | 2007/09/14 | 下载 | | 019386 | 015 | AP | Review | 2007/09/14 | 下载 | | 019386 | 012 | AP | Review | 2008/02/19 | 下载 | | 019386 | 011 | AP | Review | 2008/02/19 | 下载 | | 019386 | 010 | AP | Review | 2008/02/19 | 下载 | | 019386 | 009 | AP | Review | 2008/02/19 | 下载 | | 019386 | 007 | AP | Review | 2007/12/06 | 下载 | | 019386 | 006 | AP | Review | 2007/12/06 | 下载 | | 019386 | 005 | AP | Review | 2007/12/06 | 下载 | | 019386 | 004 | AP | Review | 2007/12/06 | 下载 | | 019386 | 002 | AP | Review | 2007/12/06 | 下载 | | 019386 | 001 | AP | Review | 2007/12/06 | 下载 | | 019386 | 000 | AP | Review | 2004/10/04 | 下载 |
|
| 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 | | 019386 | 048 | AP | 2015/08/14 | Manufacturing Change or Addition | | 019386 | 047 | AP | 2015/01/26 | Manufacturing Change or Addition | | 019386 | 046 | AP | 2014/03/20 | Manufacturing Change or Addition | | 019386 | 043 | AP | 2012/12/11 | Labeling Revision | | 019386 | 041 | AP | 2013/08/13 | Manufacturing Change or Addition | | 019386 | 039 | AP | 2007/11/06 | Labeling Revision | | 019386 | 024 | AP | 2003/08/18 | Formulation Revision | | 019386 | 022 | AP | 2003/05/28 | Manufacturing Change or Addition | | 019386 | 021 | AP | 2003/02/25 | Formulation Revision | | 019386 | 020 | AP | 2003/01/27 | Formulation Revision | | 019386 | 019 | AP | 2003/01/27 | Formulation Revision | | 019386 | 018 | AP | 2001/02/16 | Package Change | | 019386 | 017 | AP | 2001/01/26 | Control Supplement | | 019386 | 016 | AP | 2000/01/19 | Labeling Revision | | 019386 | 015 | AP | 2000/02/23 | Manufacturing Change or Addition | | 019386 | 013 | AP | 1995/10/04 | Labeling Revision | | 019386 | 012 | AP | 1994/01/13 | Control Supplement | | 019386 | 011 | AP | 1993/11/24 | Control Supplement | | 019386 | 010 | AP | 1993/07/01 | Labeling Revision | | 019386 | 009 | AP | 1991/10/21 | Labeling Revision | | 019386 | 008 | AP | 1992/12/18 | New Dosage Regimen | | 019386 | 007 | AP | 1989/05/11 | Labeling Revision | | 019386 | 006 | AP | 1988/08/15 | Labeling Revision | | 019386 | 005 | AP | 1989/05/26 | Manufacturing Change or Addition | | 019386 | 004 | AP | 1988/08/15 | Control Supplement | | 019386 | 003 | AP | 1992/12/18 | New or Modified Indication | | 019386 | 002 | AP | 1988/08/15 | Labeling Revision | | 019386 | 001 | AP | 1988/08/15 | Package Change | | 019386 | 000 | AP | 1986/12/31 | Approval |
|