| 药品名称 | ARICEPT | | 申请号 | 020690 | 产品号 | 002 | | 活性成分 | DONEPEZIL HYDROCHLORIDE | 市场状态 | 处方药 | | 剂型或给药途径 | TABLET;ORAL | 规格 | 5MG | | 治疗等效代码 | AB | 参比药物 | 否 | | 批准日期 | 1996/11/25 | 申请机构 | EISAI INC
| | 化学类型 | New molecular entity (NME) | 审评分类 | Priority 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 | | I-529 | 2009/10/13 |
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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 | | 020690 | 039 | AP | Letter | 2015/07/22 | 下载 | | 020690 | 039 | AP | Label | 2015/07/22 | 下载 | | 020690 | 037 | AP | Label | 2013/09/09 | 下载 | | 020690 | 037 | AP | Letter | 2013/09/10 | 下载 | | 020690 | 036 | AP | Letter | 2012/09/06 | 下载 | | 020690 | 036 | AP | Label | 2012/09/26 | 下载 | | 020690 | 035 | AP | Letter | 2012/03/05 | 下载 | | 020690 | 035 | AP | Label | 2012/03/09 | 下载 | | 020690 | 033 | AP | Letter | 2010/11/30 | 下载 | | 020690 | 033 | AP | Label | 2010/12/01 | 下载 | | 020690 | 031 | AP | Letter | 2013/04/09 | 下载 | | 020690 | 026 | AP | Letter | 2006/10/18 | 下载 | | 020690 | 026 | AP | Label | 2006/10/18 | 下载 | | 020690 | 011 | AP | Review | 2011/02/15 | 下载 | | 020690 | 011 | AP | Letter | 2004/05/07 | 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 | | 020690 | 040 | AP | 2016/08/17 | Manufacturing Change or Addition | | 020690 | 039 | AP | 2015/07/20 | Labeling Revision | | 020690 | 037 | AP | 2013/09/06 | Labeling Revision | | 020690 | 036 | AP | 2012/09/04 | Labeling Revision | | 020690 | 035 | AP | 2012/03/01 | Labeling Revision | | 020690 | 033 | AP | 2010/12/02 | Labeling Revision | | 020690 | 031 | AP | 2013/04/04 | Labeling Revision | | 020690 | 026 | AP | 2006/10/13 | New or Modified Indication | | 020690 | 019 | AP | 2002/01/07 | Manufacturing Change or Addition | | 020690 | 018 | AP | 2002/01/07 | Manufacturing Change or Addition | | 020690 | 017 | AP | 2001/10/03 | Control Supplement | | 020690 | 016 | AP | 2001/06/20 | Labeling Revision | | 020690 | 015 | AP | 2000/09/21 | Package Change | | 020690 | 013 | AP | 2000/03/28 | Manufacturing Change or Addition | | 020690 | 012 | AP | 2000/02/28 | Labeling Revision | | 020690 | 011 | AP | 2004/05/05 | Labeling Revision | | 020690 | 010 | AP | 1999/08/18 | Manufacturing Change or Addition | | 020690 | 009 | AP | 1999/02/10 | Package Change | | 020690 | 008 | AP | 2000/02/28 | Labeling Revision | | 020690 | 007 | AP | 1998/11/04 | Manufacturing Change or Addition | | 020690 | 006 | AP | 1998/10/16 | Manufacturing Change or Addition | | 020690 | 005 | AP | 1998/08/18 | Labeling Revision | | 020690 | 004 | AP | 1998/08/13 | Expiration Date Change | | 020690 | 003 | AP | 1998/08/13 | Control Supplement | | 020690 | 000 | AP | 1996/11/25 | Approval |
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