| 药品名称 | XOPENEX | | 申请号 | 020837 | 产品号 | 004 | | 活性成分 | LEVALBUTEROL HYDROCHLORIDE | 市场状态 | 处方药 | | 剂型或给药途径 | SOLUTION;INHALATION | 规格 | EQ 0.25% BASE | | 治疗等效代码 | AN | 参比药物 | 是 | | 批准日期 | 2003/07/18 | 申请机构 | OAK PHARMACEUTICALS INC SUBSIDIARY OF AKORN 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 | | M-151 | 2018/01/22 | | 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 | | 020837 | 043 | AP | Letter | 2015/04/02 | 下载 | | 020837 | 043 | AP | Label | 2015/04/14 | 下载 | | 020837 | 041 | AP | Letter | 2015/01/23 | 下载 | | 020837 | 041 | AP | Label | 2015/01/29 | 下载 | | 020837 | 040 | AP | Letter | 2014/01/22 | 下载 | | 020837 | 039 | AP | Label | 2014/04/01 | 下载 | | 020837 | 039 | AP | Letter | 2014/04/02 | 下载 | | 020837 | 038 | AP | Letter | 2013/09/23 | 下载 | | 020837 | 038 | AP | Label | 2013/09/24 | 下载 | | 020837 | 036 | AP | Letter | 2012/09/10 | 下载 | | 020837 | 036 | AP | Label | 2012/09/11 | 下载 | | 020837 | 020 | AP | Letter | 2006/09/18 | 下载 | | 020837 | 010 | AP | Review | 2006/10/26 | 下载 | | 020837 | 010 | AP | Letter | 2003/07/28 | 下载 | | 020837 | 006 | AP | Label | 2002/01/30 | 下载 | | 020837 | 000 | AP | Review | 1999/03/25 | 下载 | | 020837 | 000 | AP | Letter | 1999/03/25 | 下载 | | 020837 | 000 | AP | Label | 1999/03/25 | 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 | | 020837 | 043 | AP | 2015/03/31 | Labeling Revision | | 020837 | 042 | AP | 2014/12/15 | Manufacturing Change or Addition | | 020837 | 041 | AP | 2015/01/22 | Efficacy Supplement with Clinical Data to Support | | 020837 | 040 | AP | 2014/01/14 | Labeling Revision | | 020837 | 040 | AP | 2014/01/15 | Labeling Revision | | 020837 | 039 | AP | 2014/03/31 | Labeling Revision | | 020837 | 038 | AP | 2013/09/20 | Labeling Revision | | 020837 | 037 | AP | 2013/01/09 | Manufacturing Change or Addition | | 020837 | 036 | AP | 2012/09/07 | Labeling Revision | | 020837 | 035 | AP | 2013/01/09 | Manufacturing Change or Addition | | 020837 | 020 | AP | 2006/09/07 | Labeling Revision | | 020837 | 010 | AP | 2003/07/18 | Control Supplement | | 020837 | 008 | AP | 2002/08/07 | Control Supplement | | 020837 | 007 | AP | 2002/03/04 | Manufacturing Change or Addition | | 020837 | 006 | AP | 2002/01/30 | Patient Population Altered | | 020837 | 005 | AP | 2001/02/16 | Expiration Date Change | | 020837 | 004 | AP | 2000/12/04 | Control Supplement | | 020837 | 003 | AP | 2000/04/12 | Package Change | | 020837 | 001 | AP | 1999/09/21 | Manufacturing Change or Addition | | 020837 | 000 | AP | 1999/03/25 | Approval |
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