药品名称 | SANDIMMUNE | 申请号 | 050625 | 产品号 | 002 | 活性成分 | CYCLOSPORINE | 市场状态 | 处方药 | 剂型或给药途径 | CAPSULE;ORAL | 规格 | 100MG | 治疗等效代码 | AB2 | 参比药物 | 是 | 批准日期 | 1990/03/02 | 申请机构 | NOVARTIS PHARMACEUTICALS CORP
| 化学类型 | New dosage form | 审评分类 | Priority review drug |
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与本品相关的专利信息(来自橙皮书Orange Book) | 专利号 | 专利过期日 | 是否化合物专利 | 是否产品专利 | 专利用途代码 | 专利下载 | 无 | 历史专利信息 | 无 |
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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 | 050625 | 055 | AP | Label | 2015/04/01 | 下载 | 050625 | 055 | AP | Letter | 2015/04/02 | 下载 | 050625 | 053 | AP | Letter | 2013/05/07 | 下载 | 050625 | 053 | AP | Label | 2013/05/09 | 下载 | 050625 | 049 | AP | Label | 2012/08/31 | 下载 | 050625 | 049 | AP | Letter | 2012/09/05 | 下载 | 050625 | 048 | AP | Letter | 2010/05/06 | 下载 | 050625 | 048 | AP | Label | 2010/05/07 | 下载 | 050625 | 047 | AP | Label | 2009/10/14 | 下载 | 050625 | 047 | AP | Letter | 2009/11/10 | 下载 | 050625 | 044 | AP | Label | 2006/03/10 | 下载 | 050625 | 044 | AP | Letter | 2006/03/23 | 下载 | 050625 | 043 | AP | Letter | 2005/07/26 | 下载 | 050625 | 043 | AP | Label | 2005/07/26 | 下载 | 050625 | 040 | AP | Label | 2004/03/03 | 下载 | 050625 | 040 | AP | Letter | 2004/06/17 | 下载 | 050625 | 039 | AP | Letter | 2004/02/27 | 下载 | 050625 | 039 | AP | Label | 2004/03/03 | 下载 | 050625 | 032 | AP | Label | 2003/03/05 | 下载 | 050625 | 032 | AP | Letter | 2004/06/17 | 下载 | 050625 | 030 | AP | Label | 2003/03/05 | 下载 | 050625 | 030 | AP | Letter | 2004/06/17 | 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 | 050625 | 057 | AP | 2016/01/06 | Manufacturing Change or Addition | 050625 | 055 | AP | 2015/03/31 | Labeling Revision | 050625 | 053 | AP | 2013/05/03 | Labeling Revision | 050625 | 049 | AP | 2012/08/30 | Labeling Revision | 050625 | 048 | AP | 2010/04/30 | Labeling Revision | 050625 | 047 | AP | 2009/10/08 | Labeling Revision | 050625 | 044 | AP | 2006/03/06 | Labeling Revision | 050625 | 043 | AP | 2005/07/19 | Labeling Revision | 050625 | 040 | AP | 2004/02/06 | Labeling Revision | 050625 | 039 | AP | 2004/02/06 | Labeling Revision | 050625 | 034 | AP | 2002/04/12 | Manufacturing Change or Addition | 050625 | 033 | AP | 2002/01/16 | Manufacturing Change or Addition | 050625 | 032 | AP | 2003/02/14 | Labeling Revision | 050625 | 030 | AP | 2003/02/14 | Labeling Revision | 050625 | 029 | AP | 2000/06/30 | Manufacturing Change or Addition | 050625 | 028 | AP | 1999/12/21 | Labeling Revision | 050625 | 027 | AP | 2000/10/04 | Labeling Revision | 050625 | 025 | AP | 1998/03/30 | Manufacturing Change or Addition | 050625 | 024 | AP | 1996/04/15 | Control Supplement | 050625 | 023 | AP | 1996/08/09 | Labeling Revision | 050625 | 022 | AP | 1995/11/21 | Labeling Revision | 050625 | 021 | AP | 1995/11/21 | Expiration Date Change | 050625 | 020 | AP | 1995/01/13 | Control Supplement | 050625 | 019 | AP | 1994/11/10 | Labeling Revision | 050625 | 018 | AP | 1995/03/07 | Manufacturing Change or Addition | 050625 | 017 | AP | 1994/05/09 | Control Supplement | 050625 | 016 | AP | 1994/05/09 | Control Supplement | 050625 | 014 | AP | 1993/05/17 | Package Change | 050625 | 013 | AP | 1992/11/02 | Package Change | 050625 | 012 | AP | 1993/03/19 | Control Supplement | 050625 | 011 | AP | 1992/11/23 | Control Supplement | 050625 | 010 | AP | 1992/02/21 | Control Supplement | 050625 | 009 | AP | 1991/06/10 | Labeling Revision | 050625 | 007 | AP | 1992/12/30 | Expiration Date Change | 050625 | 006 | AP | 1992/12/30 | Control Supplement | 050625 | 003 | AP | 1990/08/24 | Labeling Revision | 050625 | 002 | AP | 1991/11/21 | Package Change | 050625 | 000 | AP | 1990/03/02 | Approval |
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