| 药品名称 | PULMICORT RESPULES | | 申请号 | 020929 | 产品号 | 001 | | 活性成分 | BUDESONIDE | 市场状态 | 处方药 | | 剂型或给药途径 | SUSPENSION;INHALATION | 规格 | 0.25MG/2ML | | 治疗等效代码 | AN | 参比药物 | 否 | | 批准日期 | 2000/08/08 | 申请机构 | ASTRAZENECA PHARMACEUTICALS LP
| | 化学类型 | New dosage form | 审评分类 | Priority 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 | | 020929 | 044 | AP | Label | 2010/07/06 | 下载 | | 020929 | 044 | AP | Letter | 2010/07/23 | 下载 | | 020929 | 043 | AP | Label | 2009/10/14 | 下载 | | 020929 | 043 | AP | Letter | 2009/11/10 | 下载 | | 020929 | 032 | AP | Letter | 2007/07/05 | 下载 | | 020929 | 022 | AP | Letter | 2005/07/08 | 下载 | | 020929 | 015 | AP | Label | 2003/09/30 | 下载 | | 020929 | 015 | AP | Letter | 2003/09/26 | 下载 | | 020929 | 015 | AP | Review | 2007/04/11 | 下载 | | 020929 | 013 | AP | Review | 2007/04/11 | 下载 | | 020929 | 013 | AP | Label | 2003/02/26 | 下载 | | 020929 | 013 | AP | Letter | 2003/03/10 | 下载 | | 020929 | 012 | AP | Letter | 2003/01/10 | 下载 | | 020929 | 002 | AP | Letter | 2006/07/21 | 下载 | | 020929 | 000 | AP | Review | 2004/02/11 | 下载 | | 020929 | 000 | AP | Letter | 2000/08/08 | 下载 | | 020929 | 000 | AP | Label | 2000/08/08 | 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 | | 020929 | 051 | AP | 2015/08/18 | Manufacturing Change or Addition | | 020929 | 050 | AP | 2013/04/10 | Manufacturing Change or Addition | | 020929 | 049 | AP | 2013/05/15 | Manufacturing Change or Addition | | 020929 | 044 | AP | 2010/07/02 | Labeling Revision | | 020929 | 043 | AP | 2009/10/05 | Labeling Revision | | 020929 | 032 | AP | 2007/06/18 | Labeling Revision | | 020929 | 022 | AP | 2005/06/30 | Efficacy Supplement with Clinical Data to Support | | 020929 | 015 | AP | 2003/09/26 | Labeling Revision | | 020929 | 013 | AP | 2003/02/26 | Efficacy Supplement with Clinical Data to Support | | 020929 | 012 | AP | 2003/01/10 | Labeling Revision | | 020929 | 011 | AP | 2002/07/25 | Manufacturing Change or Addition | | 020929 | 009 | AP | 2001/09/24 | Control Supplement | | 020929 | 008 | AP | 2001/05/16 | Control Supplement | | 020929 | 007 | AP | 2001/05/16 | Control Supplement | | 020929 | 006 | AP | 2001/05/16 | Control Supplement | | 020929 | 005 | AP | 2001/06/18 | Control Supplement | | 020929 | 004 | AP | 2001/04/25 | Control Supplement | | 020929 | 003 | AP | 2001/07/16 | Control Supplement | | 020929 | 002 | AP | 2006/07/21 | Control Supplement | | 020929 | 001 | AP | 2001/02/09 | Control Supplement | | 020929 | 000 | AP | 2000/08/08 | Approval |
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