| 药品名称 | INTEGRILIN | | 申请号 | 020718 | 产品号 | 002 | | 活性成分 | EPTIFIBATIDE | 市场状态 | 处方药 | | 剂型或给药途径 | INJECTABLE;INJECTION | 规格 | 75MG/100ML | | 治疗等效代码 | AP | 参比药物 | 是 | | 批准日期 | 1998/05/18 | 申请机构 | SCHERING CORP
| | 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 | | 020718 | 037 | AP | Label | 2013/03/25 | 下载 | | 020718 | 037 | AP | Letter | 2013/03/26 | 下载 | | 020718 | 034 | AP | Label | 2011/04/01 | 下载 | | 020718 | 034 | AP | Letter | 2011/04/04 | 下载 | | 020718 | 028 | AP | Letter | 2008/12/19 | 下载 | | 020718 | 028 | AP | Label | 2009/01/02 | 下载 | | 020718 | 025 | AP | Letter | 2005/10/14 | 下载 | | 020718 | 025 | AP | Label | 2005/10/14 | 下载 | | 020718 | 022 | AP | Letter | 2004/07/21 | 下载 | | 020718 | 017 | AP | Letter | 2003/06/22 | 下载 | | 020718 | 017 | AP | Label | 2003/06/22 | 下载 | | 020718 | 013 | AP | Letter | 2001/06/08 | 下载 | | 020718 | 013 | AP | Label | 2001/06/08 | 下载 | | 020718 | 013 | AP | Review | 2001/06/08 | 下载 | | 020718 | 010 | AP | Letter | 2001/06/08 | 下载 | | 020718 | 010 | AP | Label | 2001/06/08 | 下载 | | 020718 | 010 | AP | Review | 2001/06/08 | 下载 | | 020718 | 002 | AP | Letter | 1999/09/20 | 下载 | | 020718 | 002 | AP | Label | 1999/09/20 | 下载 | | 020718 | 002 | AP | Review | 1999/09/20 | 下载 | | 020718 | 000 | AP | Review | 1998/05/18 | 下载 | | 020718 | 000 | AP | Letter | 1998/05/18 | 下载 | | 020718 | 000 | AP | Label | 1998/05/18 | 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 | | 020718 | 037 | AP | 2013/03/25 | Labeling Revision | | 020718 | 034 | AP | 2011/03/30 | Labeling Revision | | 020718 | 028 | AP | 2008/12/15 | Labeling Revision | | 020718 | 025 | AP | 2005/10/12 | Labeling Revision | | 020718 | 022 | AP | 2004/07/15 | Labeling Revision | | 020718 | 017 | AP | 2003/06/16 | Efficacy Supplement with Clinical Data to Support | | 020718 | 016 | AP | 2002/02/14 | Manufacturing Change or Addition | | 020718 | 015 | AP | 2002/01/10 | Control Supplement | | 020718 | 014 | AP | 2001/07/26 | Manufacturing Change or Addition | | 020718 | 013 | AP | 2001/06/08 | Labeling Revision | | 020718 | 011 | AP | 2001/07/03 | Manufacturing Change or Addition | | 020718 | 010 | AP | 2001/06/08 | New Dosage Regimen | | 020718 | 009 | AP | 2000/05/31 | Control Supplement | | 020718 | 008 | AP | 2000/06/26 | Manufacturing Change or Addition | | 020718 | 007 | AP | 2000/03/03 | Control Supplement | | 020718 | 006 | AP | 1999/12/03 | Manufacturing Change or Addition | | 020718 | 005 | AP | 1999/04/16 | Manufacturing Change or Addition | | 020718 | 004 | AP | 1999/07/21 | Control Supplement | | 020718 | 003 | AP | 1999/07/21 | Labeling Revision | | 020718 | 002 | AP | 1999/09/20 | Efficacy Supplement with Clinical Data to Support | | 020718 | 001 | AP | 1998/09/11 | Labeling Revision | | 020718 | 000 | AP | 1998/05/18 | Approval |
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