药品名称 | SYMBICORT | 申请号 | 021929 | 产品号 | 001 | 活性成分 | BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE | 市场状态 | 处方药 | 剂型或给药途径 | AEROSOL, METERED;INHALATION | 规格 | 0.08MG/INH;0.0045MG/INH | 治疗等效代码 | | 参比药物 | 是 | 批准日期 | 2006/07/21 | 申请机构 | ASTRAZENECA LP
| 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-582 | 2012/02/27 | NC | 2009/07/21 |
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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 | 021929 | 033 | AP | Letter | 2012/07/25 | 下载 | 021929 | 028 | AP | Letter | 2011/08/22 | 下载 | 021929 | 021 | AP | Label | 2010/06/28 | 下载 | 021929 | 021 | AP | Letter | 2010/06/29 | 下载 | 021929 | 019 | AP | Letter | 2011/02/18 | 下载 | 021929 | 012 | AP | Review | 2012/03/02 | 下载 | 021929 | 012 | AP | Letter | 2009/03/03 | 下载 | 021929 | 012 | AP | Label | 2009/04/03 | 下载 | 021929 | 010 | AP | Label | 2008/07/16 | 下载 | 021929 | 010 | AP | Letter | 2008/07/17 | 下载 | 021929 | 006 | AP | Label | 2007/11/07 | 下载 | 021929 | 006 | AP | Letter | 2007/11/08 | 下载 | 021929 | 004 | AP | Label | 2007/11/07 | 下载 | 021929 | 004 | AP | Letter | 2007/11/08 | 下载 | 021929 | 000 | AP | Label | 2006/07/21 | 下载 | 021929 | 000 | AP | Letter | 2006/07/21 | 下载 | 021929 | 000 | AP | Other Important Information from FDA | 2007/02/21 | 下载 | 021929 | 000 | AP | Review | 2008/10/30 | 下载 | 021929 | 000 | AP | Medication Guide | 2009/12/04 | 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 | 021929 | 040 | AP | 2016/06/10 | Manufacturing Change or Addition | 021929 | 039 | AP | 2014/06/28 | Manufacturing Change or Addition | 021929 | 039 | AP | 2014/12/02 | Manufacturing Change or Addition | 021929 | 038 | AP | 2015/04/14 | Manufacturing Change or Addition | 021929 | 037 | AP | 2014/04/04 | Manufacturing Change or Addition | 021929 | 036 | AP | 2014/02/27 | Manufacturing Change or Addition | 021929 | 035 | AP | 2014/01/15 | Manufacturing Change or Addition | 021929 | 033 | AP | 2012/07/23 | Supplement | 021929 | 028 | AP | 2011/08/18 | Labeling Revision | 021929 | 021 | AP | 2010/06/25 | Labeling Revision | 021929 | 019 | AP | 2011/02/16 | Labeling Revision | 021929 | 012 | AP | 2009/02/27 | New or Modified Indication | 021929 | 010 | AP | 2008/07/16 | Labeling Revision | 021929 | 006 | AP | 2007/10/26 | Control Supplement | 021929 | 004 | AP | 2007/10/31 | Labeling Revision | 021929 | 000 | AP | 2006/07/21 | Approval |
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