| 药品名称 | QVAR 80 | | 申请号 | 020911 | 产品号 | 001 | | 活性成分 | BECLOMETHASONE DIPROPIONATE | 市场状态 | 处方药 | | 剂型或给药途径 | AEROSOL, METERED;INHALATION | 规格 | 0.08MG/INH | | 治疗等效代码 | | 参比药物 | 是 | | 批准日期 | 2000/09/15 | 申请机构 | TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC
| | 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 | | 020911 | 026 | AP | Letter | 2014/05/23 | 下载 | | 020911 | 026 | AP | Label | 2014/05/28 | 下载 | | 020911 | 025 | AP | Letter | 2014/07/24 | 下载 | | 020911 | 025 | AP | Label | 2014/07/30 | 下载 | | 020911 | 022 | AP | Label | 2012/07/30 | 下载 | | 020911 | 022 | AP | Letter | 2012/08/01 | 下载 | | 020911 | 017 | AP | Letter | 2008/08/20 | 下载 | | 020911 | 017 | AP | Label | 2008/08/26 | 下载 | | 020911 | 015 | AP | Letter | 2006/11/22 | 下载 | | 020911 | 015 | AP | Label | 2007/01/16 | 下载 | | 020911 | 008 | AP | Letter | 2003/08/15 | 下载 | | 020911 | 005 | AP | Letter | 2002/05/09 | 下载 | | 020911 | 000 | AP | Review | 2004/02/11 | 下载 | | 020911 | 000 | AP | Letter | 2004/06/14 | 下载 | | 020911 | 000 | AP | Label | 2004/06/14 | 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 | | 020911 | 027 | AP | 2015/12/16 | Manufacturing Change or Addition | | 020911 | 026 | AP | 2014/05/22 | Manufacturing Change or Addition | | 020911 | 025 | AP | 2014/07/21 | Labeling Revision | | 020911 | 024 | AP | 2015/03/09 | Manufacturing Change or Addition | | 020911 | 023 | AP | 2013/05/08 | Manufacturing Change or Addition | | 020911 | 022 | AP | 2012/07/30 | Labeling Revision | | 020911 | 017 | AP | 2008/08/18 | Labeling Revision | | 020911 | 015 | AP | 2006/11/20 | Labeling Revision | | 020911 | 008 | AP | 2003/08/01 | Labeling Revision | | 020911 | 007 | AP | 2002/07/11 | Control Supplement | | 020911 | 006 | AP | 2002/01/17 | Control Supplement | | 020911 | 005 | AP | 2002/05/10 | Patient Population Altered | | 020911 | 004 | AP | 2001/08/02 | Control Supplement | | 020911 | 003 | AP | 2001/04/17 | Manufacturing Change or Addition | | 020911 | 002 | AP | 2001/03/27 | Control Supplement | | 020911 | 001 | AP | 2001/02/01 | Control Supplement | | 020911 | 000 | AP | 2000/09/15 | Approval |
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