药品名称 | SEREVENT | 申请号 | 020692 | 产品号 | 001 | 活性成分 | SALMETEROL XINAFOATE | 市场状态 | 处方药 | 剂型或给药途径 | POWDER;INHALATION | 规格 | EQ 0.05MG BASE/INH | 治疗等效代码 | | 参比药物 | 是 | 批准日期 | 1997/09/19 | 申请机构 | GLAXOSMITHKLINE INTELLECTUAL PROPERTY LTD ENGLAND
| 化学类型 | New dosage form | 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 | 020692 | 045 | AP | Letter | 2016/10/05 | 下载 | 020692 | 045 | AP | Label | 2016/10/06 | 下载 | 020692 | 043 | AP | Letter | 2014/04/16 | 下载 | 020692 | 043 | AP | Label | 2014/04/16 | 下载 | 020692 | 042 | AP | Letter | 2012/08/13 | 下载 | 020692 | 039 | AP | Letter | 2011/07/05 | 下载 | 020692 | 038 | AP | Letter | 2011/05/12 | 下载 | 020692 | 038 | AP | Label | 2011/05/16 | 下载 | 020692 | 038 | AP | Medication Guide | 2011/05/16 | 下载 | 020692 | 036 | AP | Label | 2010/06/28 | 下载 | 020692 | 036 | AP | Letter | 2010/06/29 | 下载 | 020692 | 035 | AP | Letter | 2010/11/22 | 下载 | 020692 | 032 | AP | Label | 2011/01/04 | 下载 | 020692 | 032 | AP | Letter | 2011/01/04 | 下载 | 020692 | 031 | AP | Letter | 2008/03/21 | 下载 | 020692 | 031 | AP | Label | 2008/03/24 | 下载 | 020692 | 029 | AP | Label | 2006/03/03 | 下载 | 020692 | 029 | AP | Letter | 2006/03/23 | 下载 | 020692 | 028 | AP | Label | 2007/02/26 | 下载 | 020692 | 028 | AP | Letter | 2007/03/01 | 下载 | 020692 | 026 | AP | Letter | 2004/10/04 | 下载 | 020692 | 026 | AP | Label | 2004/10/04 | 下载 | 020692 | 024 | AP | Label | 2003/08/15 | 下载 | 020692 | 024 | AP | Letter | 2003/08/15 | 下载 | 020692 | 024 | AP | Review | 2008/08/01 | 下载 | 020692 | 016 | AP | Letter | 2002/03/22 | 下载 | 020692 | 016 | AP | Label | 2002/03/22 | 下载 | 020692 | 002 | AP | Letter | 1998/09/25 | 下载 | 020692 | 002 | AP | Review | 1998/09/25 | 下载 | 020692 | 002 | AP | Label | 1998/09/25 | 下载 | 020692 | 001 | AP | Letter | 1998/09/25 | 下载 | 020692 | 001 | AP | Review | 1998/09/25 | 下载 | 020692 | 001 | AP | Label | 1998/09/25 | 下载 | 020692 | 000 | AP | Other Important Information from FDA | 2005/11/30 | 下载 | 020692 | 000 | AP | Review | 2005/12/06 | 下载 | 020692 | 000 | AP | Medication Guide | 2009/11/20 | 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 | 020692 | 045 | AP | 2016/09/30 | Labeling Revision | 020692 | 044 | AP | 2016/06/17 | Manufacturing Change or Addition | 020692 | 043 | AP | 2014/04/14 | Labeling Revision | 020692 | 042 | AP | 2012/08/09 | Labeling Revision | 020692 | 040 | AP | 2012/08/09 | Labeling Revision | 020692 | 039 | AP | 2011/06/27 | Labeling Revision | 020692 | 038 | AP | 2011/05/10 | Labeling Revision | 020692 | 036 | AP | 2010/06/25 | Labeling Revision | 020692 | 035 | AP | 2010/11/18 | Labeling Revision | 020692 | 032 | AP | 2010/12/30 | Labeling Revision | 020692 | 031 | AP | 2008/03/20 | Labeling Revision | 020692 | 029 | AP | 2006/03/02 | Labeling Revision | 020692 | 028 | AP | 2007/02/23 | Labeling Revision | 020692 | 026 | AP | 2004/09/28 | Labeling Revision | 020692 | 024 | AP | 2003/08/11 | Labeling Revision | 020692 | 020 | AP | 2002/05/17 | Control Supplement | 020692 | 018 | AP | 2002/05/15 | Manufacturing Change or Addition | 020692 | 017 | AP | 2001/10/16 | Control Supplement | 020692 | 016 | AP | 2002/03/22 | New or Modified Indication | 020692 | 015 | AP | 2001/05/17 | Labeling Revision | 020692 | 013 | AP | 2000/06/15 | Control Supplement | 020692 | 012 | AP | 2000/04/03 | Control Supplement | 020692 | 011 | AP | 2000/06/29 | Efficacy Supplement with Clinical Data to Support | 020692 | 010 | AP | 1999/07/20 | Manufacturing Change or Addition | 020692 | 009 | AP | 2001/01/19 | Control Supplement | 020692 | 008 | AP | 1998/03/18 | Control Supplement | 020692 | 007 | AP | 1998/03/11 | Labeling Revision | 020692 | 006 | AP | 1998/12/03 | Control Supplement | 020692 | 004 | AP | 1998/03/18 | Control Supplement | 020692 | 003 | AP | 1998/03/26 | Control Supplement | 020692 | 002 | AP | 1998/09/25 | Patient Population Altered | 020692 | 001 | AP | 1998/09/25 | New or Modified Indication | 020692 | 000 | AP | 1997/09/19 | Approval |
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