| 药品名称 | PRANDIN | | 申请号 | 020741 | 产品号 | 001 | | 活性成分 | REPAGLINIDE | 市场状态 | 处方药 | | 剂型或给药途径 | TABLET;ORAL | 规格 | 0.5MG | | 治疗等效代码 | AB | 参比药物 | 否 | | 批准日期 | 1997/12/22 | 申请机构 | NOVO NORDISK 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 | | 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 | | 020741 | 040 | AP | Letter | 2012/03/05 | 下载 | | 020741 | 040 | AP | Label | 2012/03/06 | 下载 | | 020741 | 038 | AP | Label | 2010/07/31 | 下载 | | 020741 | 038 | AP | Letter | 2010/08/03 | 下载 | | 020741 | 035 | AP | Letter | 2009/06/16 | 下载 | | 020741 | 035 | AP | Label | 2009/06/22 | 下载 | | 020741 | 034 | AP | Label | 2008/07/15 | 下载 | | 020741 | 034 | AP | Letter | 2008/07/15 | 下载 | | 020741 | 030 | AP | Review | 2007/07/06 | 下载 | | 020741 | 030 | AP | Letter | 2006/06/28 | 下载 | | 020741 | 022 | AP | Label | 2005/02/11 | 下载 | | 020741 | 022 | AP | Letter | 2005/02/11 | 下载 | | 020741 | 019 | AP | Letter | 2003/10/17 | 下载 | | 020741 | 019 | AP | Review | 2007/07/06 | 下载 | | 020741 | 018 | AP | Letter | 2003/08/29 | 下载 | | 020741 | 018 | AP | Label | 2003/08/29 | 下载 | | 020741 | 016 | AP | Review | 2007/07/06 | 下载 | | 020741 | 015 | AP | Review | 2007/07/06 | 下载 | | 020741 | 013 | AP | Letter | 2002/10/21 | 下载 | | 020741 | 013 | AP | Label | 2002/10/21 | 下载 | | 020741 | 012 | AP | Letter | 2002/01/18 | 下载 | | 020741 | 012 | AP | Label | 2002/01/18 | 下载 | | 020741 | 009 | AP | Review | 2007/07/06 | 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 | | 020741 | 043 | AP | 2015/10/30 | Manufacturing Change or Addition | | 020741 | 040 | AP | 2012/03/01 | Labeling Revision | | 020741 | 038 | AP | 2010/07/29 | Labeling Revision | | 020741 | 035 | AP | 2009/06/10 | Labeling Revision | | 020741 | 034 | AP | 2008/07/14 | Labeling Revision | | 020741 | 030 | AP | 2006/06/19 | Labeling Revision | | 020741 | 022 | AP | 2005/02/10 | Labeling Revision | | 020741 | 019 | AP | 2003/10/15 | Package Change | | 020741 | 018 | AP | 2003/08/27 | Labeling Revision | | 020741 | 016 | AP | 2002/11/25 | Expiration Date Change | | 020741 | 015 | AP | 2002/10/01 | Control Supplement | | 020741 | 014 | AP | 2002/08/05 | Expiration Date Change | | 020741 | 013 | AP | 2002/10/21 | New or Modified Indication | | 020741 | 012 | AP | 2002/01/18 | Efficacy Supplement with Clinical Data to Support | | 020741 | 010 | AP | 2000/10/27 | Control Supplement | | 020741 | 009 | AP | 2000/08/15 | Manufacturing Change or Addition | | 020741 | 008 | AP | 2000/02/25 | Manufacturing Change or Addition | | 020741 | 007 | AP | 1999/11/26 | Control Supplement | | 020741 | 006 | AP | 1999/12/08 | Manufacturing Change or Addition | | 020741 | 005 | AP | 1999/08/30 | Manufacturing Change or Addition | | 020741 | 004 | AP | 1999/05/18 | Control Supplement | | 020741 | 003 | AP | 1999/05/18 | Control Supplement | | 020741 | 002 | AP | 1999/03/01 | Expiration Date Change | | 020741 | 001 | AP | 1999/08/10 | Labeling Revision | | 020741 | 000 | AP | 1997/12/22 | Approval |
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