| 药品名称 | NEORAL | | 申请号 | 050716 | 产品号 | 001 | | 活性成分 | CYCLOSPORINE | 市场状态 | 处方药 | | 剂型或给药途径 | SOLUTION;ORAL | 规格 | 100MG/ML | | 治疗等效代码 | AB1 | 参比药物 | 是 | | 批准日期 | 1995/07/14 | 申请机构 | NOVARTIS PHARMACEUTICALS CORP
| | 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 | | 050716 | 038 | AP | Label | 2015/04/01 | 下载 | | 050716 | 038 | AP | Letter | 2015/04/02 | 下载 | | 050716 | 034 | AP | Letter | 2013/05/07 | 下载 | | 050716 | 034 | AP | Label | 2013/05/09 | 下载 | | 050716 | 030 | AP | Label | 2012/08/31 | 下载 | | 050716 | 030 | AP | Letter | 2012/09/05 | 下载 | | 050716 | 029 | AP | Label | 2009/10/14 | 下载 | | 050716 | 029 | AP | Letter | 2009/11/09 | 下载 | | 050716 | 028 | AP | Letter | 2009/11/12 | 下载 | | 050716 | 028 | AP | Label | 2009/10/01 | 下载 | | 050716 | 026 | AP | Label | 2007/08/02 | 下载 | | 050716 | 026 | AP | Letter | 2007/08/02 | 下载 | | 050716 | 025 | AP | Label | 2006/03/10 | 下载 | | 050716 | 025 | AP | Letter | 2006/03/23 | 下载 | | 050716 | 024 | AP | Letter | 2005/07/26 | 下载 | | 050716 | 024 | AP | Label | 2005/07/26 | 下载 | | 050716 | 021 | AP | Letter | 2004/02/27 | 下载 | | 050716 | 021 | AP | Label | 2004/03/03 | 下载 | | 050716 | 020 | AP | Letter | 2004/02/27 | 下载 | | 050716 | 020 | AP | Label | 2004/03/03 | 下载 | | 050716 | 018 | AP | Letter | 2002/06/12 | 下载 | | 050716 | 018 | AP | Label | 2002/06/12 | 下载 | | 050716 | 014 | AP | Letter | 2002/06/12 | 下载 | | 050716 | 014 | AP | Label | 2002/06/12 | 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 | | 050716 | 038 | AP | 2015/03/31 | Labeling Revision | | 050716 | 035 | AP | 2013/08/29 | Manufacturing Change or Addition | | 050716 | 034 | AP | 2013/05/02 | Labeling Revision | | 050716 | 030 | AP | 2012/08/30 | Labeling Revision | | 050716 | 029 | AP | 2009/10/08 | Labeling Revision | | 050716 | 028 | AP | 2009/09/24 | Labeling Revision | | 050716 | 026 | AP | 2007/08/01 | Labeling Revision | | 050716 | 025 | AP | 2006/03/06 | Labeling Revision | | 050716 | 024 | AP | 2005/07/19 | Labeling Revision | | 050716 | 021 | AP | 2004/02/06 | Labeling Revision | | 050716 | 020 | AP | 2004/02/06 | Labeling Revision | | 050716 | 018 | AP | 2002/06/12 | Labeling Revision | | 050716 | 017 | AP | 2002/04/12 | Manufacturing Change or Addition | | 050716 | 016 | AP | 2002/02/22 | Control Supplement | | 050716 | 015 | AP | 2001/05/03 | Manufacturing Change or Addition | | 050716 | 014 | AP | 2002/06/12 | Labeling Revision | | 050716 | 013 | AP | 2000/11/29 | Manufacturing Change or Addition | | 050716 | 012 | AP | 1999/12/21 | Labeling Revision | | 050716 | 011 | AP | 2000/10/04 | Labeling Revision | | 050716 | 010 | AP | 1999/05/13 | Manufacturing Change or Addition | | 050716 | 008 | AP | 1998/07/24 | Manufacturing Change or Addition | | 050716 | 007 | AP | 1998/07/27 | Control Supplement | | 050716 | 006 | AP | 1998/01/30 | Control Supplement | | 050716 | 005 | AP | 1998/03/30 | Manufacturing Change or Addition | | 050716 | 004 | AP | 1997/06/19 | Labeling Revision | | 050716 | 001 | AP | 1997/03/05 | Control Supplement | | 050716 | 000 | AP | 1995/07/14 | Approval |
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