| 药品名称 | AEROSPAN HFA | | 申请号 | 021247 | 产品号 | 001 | | 活性成分 | FLUNISOLIDE | 市场状态 | 处方药 | | 剂型或给药途径 | AEROSOL, METERED;INHALATION | 规格 | 0.078MG/INH | | 治疗等效代码 | | 参比药物 | 是 | | 批准日期 | 2006/01/27 | 申请机构 | MEDA PHARMACEUTICALS
| | 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 | | M-128 | 2016/08/28 | | 历史市场独占权保护信息 | | NP | 2009/01/27 |
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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 | | 021247 | 008 | AP | Label | 2013/08/29 | 下载 | | 021247 | 008 | AP | Letter | 2013/08/29 | 下载 | | 021247 | 007 | AP | Letter | 2012/11/19 | 下载 | | 021247 | 007 | AP | Label | 2012/11/19 | 下载 | | 021247 | 000 | AP | Label | 2006/02/02 | 下载 | | 021247 | 000 | AP | Letter | 2006/02/02 | 下载 | | 021247 | 000 | AP | Review | 2008/12/22 | 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 | | 021247 | 014 | AP | 2016/04/22 | Manufacturing Change or Addition | | 021247 | 013 | AP | 2016/03/09 | Manufacturing Change or Addition | | 021247 | 012 | AP | 2015/02/09 | Manufacturing Change or Addition | | 021247 | 011 | AP | 2014/02/14 | Manufacturing Change or Addition | | 021247 | 010 | AP | 2013/12/09 | Manufacturing Change or Addition | | 021247 | 009 | AP | 2013/09/30 | Manufacturing Change or Addition | | 021247 | 008 | AP | 2013/08/28 | Efficacy Supplement with Clinical Data to Support | | 021247 | 007 | AP | 2012/11/16 | Labeling Revision | | 021247 | 000 | AP | 2006/01/27 | Approval |
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