| 药品名称 | RHINOCORT | | 申请号 | 020746 | 产品号 | 002 | | 活性成分 | BUDESONIDE | 市场状态 | 停止上市 | | 剂型或给药途径 | SPRAY, METERED;NASAL | 规格 | 0.064MG/INH | | 治疗等效代码 | | 参比药物 | 否 | | 批准日期 | | 申请机构 | ASTRAZENECA PHARMS | | 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 | | 020746 | 036 | AP | Letter | 2016/08/29 | 下载 | | 020746 | 036 | AP | Label | 2016/08/30 | 下载 | | 020746 | 034 | AP | Letter | 2016/04/25 | 下载 | | 020746 | 034 | AP | Label | 2016/05/03 | 下载 | | 020746 | 033 | AP | Letter | 2016/03/14 | 下载 | | 020746 | 033 | AP | Label | 2016/03/15 | 下载 | | 020746 | 032 | AP | Letter | 2015/03/25 | 下载 | | 020746 | 032 | AP | Label | 2015/03/25 | 下载 | | 020746 | 026 | AP | Label | 2010/12/28 | 下载 | | 020746 | 026 | AP | Letter | 2011/01/04 | 下载 | | 020746 | 024 | AP | Label | 2009/05/25 | 下载 | | 020746 | 024 | AP | Letter | 2009/05/29 | 下载 | | 020746 | 021 | AP | Label | 2007/10/22 | 下载 | | 020746 | 021 | AP | Letter | 2007/10/22 | 下载 | | 020746 | 016 | AP | Letter | 2004/08/02 | 下载 | | 020746 | 015 | AP | Letter | 2004/08/31 | 下载 | | 020746 | 015 | AP | Label | 2004/08/31 | 下载 | | 020746 | 013 | AP | Letter | 2004/01/22 | 下载 | | 020746 | 013 | AP | Label | 2004/01/22 | 下载 | | 020746 | 011 | AP | Label | 2003/09/30 | 下载 | | 020746 | 011 | AP | Letter | 2003/09/26 | 下载 | | 020746 | 004 | AP | Letter | 2001/10/26 | 下载 | | 020746 | 000 | AP | Letter | 1999/10/01 | 下载 | | 020746 | 000 | AP | Label | 1999/10/01 | 下载 | | 020746 | 000 | AP | Review | 2004/06/16 | 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 | | 020746 | 036 | AP | 2016/08/24 | Labeling Revision | | 020746 | 035 | AP | 2016/03/02 | Manufacturing Change or Addition | | 020746 | 034 | AP | 2016/04/22 | Labeling Revision | | 020746 | 033 | AP | 2016/03/10 | Labeling Revision | | 020746 | 032 | AP | 2015/03/23 | OTC Labeling | | 020746 | 031 | AP | 2013/04/29 | Manufacturing Change or Addition | | 020746 | 026 | AP | 2010/12/28 | Labeling Revision | | 020746 | 024 | AP | 2009/05/21 | Labeling Revision | | 020746 | 021 | AP | 2007/10/16 | Labeling Revision | | 020746 | 016 | AP | 2004/07/30 | Efficacy Supplement with Clinical Data to Support | | 020746 | 015 | AP | 2004/08/25 | Labeling Revision | | 020746 | 013 | AP | 2004/01/16 | Labeling Revision | | 020746 | 011 | AP | 2003/09/26 | Labeling Revision | | 020746 | 008 | AP | 2002/10/03 | Manufacturing Change or Addition | | 020746 | 007 | AP | 2002/05/31 | Control Supplement | | 020746 | 006 | AP | 2001/05/18 | Control Supplement | | 020746 | 005 | AP | 2001/06/18 | Control Supplement | | 020746 | 004 | AP | 2001/10/26 | Efficacy Supplement with Clinical Data to Support | | 020746 | 003 | AP | 2001/06/25 | Control Supplement | | 020746 | 001 | AP | 2000/09/25 | Manufacturing Change or Addition | | 020746 | 000 | AP | 1999/10/01 | Approval |
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