| 药品名称 | TEMODAR | | 申请号 | 021029 | 产品号 | 004 | | 活性成分 | TEMOZOLOMIDE | 市场状态 | 处方药 | | 剂型或给药途径 | CAPSULE;ORAL | 规格 | 250MG | | 治疗等效代码 | AB | 参比药物 | 是 | | 批准日期 | 1999/08/11 | 申请机构 | MERCK SHARP AND DOHME CORP
| | 化学类型 | New molecular entity (NME) | 审评分类 | Priority review drug | | 罕用药/孤儿药 | 是 | | |
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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 | | I-450 | 2008/03/15 | | ODE | 2006/08/11 | | ODE | 2012/03/15 | | PED | 2007/02/11 |
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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 | | 021029 | 031 | AP | Letter | 2016/02/16 | 下载 | | 021029 | 031 | AP | Label | 2016/02/18 | 下载 | | 021029 | 029 | AP | Letter | 2015/09/22 | 下载 | | 021029 | 029 | AP | Label | 2015/09/23 | 下载 | | 021029 | 028 | AP | Letter | 2015/04/03 | 下载 | | 021029 | 028 | AP | Label | 2015/04/07 | 下载 | | 021029 | 026 | AP | Letter | 2014/05/06 | 下载 | | 021029 | 026 | AP | Label | 2014/05/06 | 下载 | | 021029 | 022 | AP | Label | 2013/01/09 | 下载 | | 021029 | 021 | AP | Label | 2011/06/07 | 下载 | | 021029 | 021 | AP | Letter | 2011/06/09 | 下载 | | 021029 | 020 | AP | Label | 2011/02/09 | 下载 | | 021029 | 018 | AP | Label | 2010/04/28 | 下载 | | 021029 | 018 | AP | Letter | 2010/04/29 | 下载 | | 021029 | 012 | AP | Label | 2006/10/23 | 下载 | | 021029 | 012 | AP | Letter | 2006/10/23 | 下载 | | 021029 | 011 | AP | Letter | 2006/04/07 | 下载 | | 021029 | 010 | AP | Letter | 2005/04/28 | 下载 | | 021029 | 009 | AP | Letter | 2005/03/31 | 下载 | | 021029 | 008 | AP | Label | 2005/03/15 | 下载 | | 021029 | 008 | AP | Letter | 2005/03/18 | 下载 | | 021029 | 007 | AP | Letter | 2004/06/30 | 下载 | | 021029 | 006 | AP | Letter | 2004/07/21 | 下载 | | 021029 | 005 | AP | Label | 2003/03/26 | 下载 | | 021029 | 005 | AP | Letter | 2003/03/26 | 下载 | | 021029 | 004 | AP | Review | 2004/04/14 | 下载 | | 021029 | 004 | AP | Letter | 2002/01/18 | 下载 | | 021029 | 004 | AP | Label | 2002/01/18 | 下载 | | 021029 | 000 | AP | Letter | 1999/08/11 | 下载 | | 021029 | 000 | AP | Review | 1999/08/11 | 下载 | | 021029 | 000 | AP | Label | 1999/08/11 | 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 | | 021029 | 031 | AP | 2016/02/12 | Labeling Revision | | 021029 | 029 | AP | 2015/09/18 | Labeling Revision | | 021029 | 028 | AP | 2015/04/02 | Labeling Revision | | 021029 | 027 | AP | 2014/09/19 | Manufacturing Change or Addition | | 021029 | 026 | AP | 2014/05/05 | Labeling Revision | | 021029 | 025 | AP | 2013/10/10 | Manufacturing Change or Addition | | 021029 | 024 | AP | 2014/03/20 | Manufacturing Change or Addition | | 021029 | 022 | AP | 2013/01/08 | Manufacturing Change or Addition | | 021029 | 021 | AP | 2011/06/03 | Labeling Revision | | 021029 | 020 | AP | 2011/02/04 | Labeling Revision | | 021029 | 018 | AP | 2010/04/26 | Labeling Revision | | 021029 | 012 | AP | 2006/10/19 | Manufacturing Change or Addition | | 021029 | 011 | AP | 2006/03/31 | Labeling Revision | | 021029 | 010 | AP | 2005/04/22 | Labeling Revision | | 021029 | 009 | AP | 2005/03/30 | Labeling Revision | | 021029 | 008 | AP | 2005/03/15 | New or Modified Indication | | 021029 | 007 | AP | 2004/06/29 | Labeling Revision | | 021029 | 006 | AP | 2004/07/15 | Labeling Revision | | 021029 | 005 | AP | 2003/03/11 | Efficacy Supplement with Clinical Data to Support | | 021029 | 004 | AP | 2002/01/18 | Labeling Revision | | 021029 | 003 | AP | 2002/03/05 | Control Supplement | | 021029 | 002 | AP | 2001/05/18 | Control Supplement | | 021029 | 001 | AP | 2000/06/09 | Control Supplement | | 021029 | 000 | AP | 1999/08/11 | Approval |
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