| 药品名称 | CAMPTOSAR | | 申请号 | 020571 | 产品号 | 001 | | 活性成分 | IRINOTECAN HYDROCHLORIDE | 市场状态 | 处方药 | | 剂型或给药途径 | INJECTABLE;INJECTION | 规格 | 40MG/2ML (20MG/ML) | | 治疗等效代码 | AP | 参比药物 | 是 | | 批准日期 | 1996/06/14 | 申请机构 | PFIZER 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 | | M-34 | 2007/06/24 | | PED | 2007/12/24 |
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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 | | 020571 | 048 | AP | Letter | 2014/12/23 | 下载 | | 020571 | 048 | AP | Label | 2015/01/09 | 下载 | | 020571 | 042 | AP | Letter | 2012/07/17 | 下载 | | 020571 | 042 | AP | Label | 2012/07/25 | 下载 | | 020571 | 037 | AP | Letter | 2010/05/21 | 下载 | | 020571 | 037 | AP | Label | 2010/05/28 | 下载 | | 020571 | 036 | AP | Letter | 2010/05/21 | 下载 | | 020571 | 036 | AP | Label | 2010/05/28 | 下载 | | 020571 | 033 | AP | Label | 2010/05/28 | 下载 | | 020571 | 033 | AP | Letter | 2010/05/21 | 下载 | | 020571 | 032 | AP | Letter | 2010/05/21 | 下载 | | 020571 | 032 | AP | Label | 2010/05/28 | 下载 | | 020571 | 031 | AP | Label | 2010/05/28 | 下载 | | 020571 | 031 | AP | Letter | 2010/05/21 | 下载 | | 020571 | 030 | AP | Label | 2006/08/04 | 下载 | | 020571 | 030 | AP | Letter | 2006/08/04 | 下载 | | 020571 | 028 | AP | Label | 2005/07/26 | 下载 | | 020571 | 028 | AP | Letter | 2005/07/26 | 下载 | | 020571 | 027 | AP | Letter | 2005/07/26 | 下载 | | 020571 | 027 | AP | Label | 2005/07/26 | 下载 | | 020571 | 026 | AP | Letter | 2005/06/08 | 下载 | | 020571 | 026 | AP | Label | 2005/06/08 | 下载 | | 020571 | 024 | AP | Letter | 2005/07/26 | 下载 | | 020571 | 024 | AP | Label | 2005/07/26 | 下载 | | 020571 | 023 | AP | Letter | 2004/12/08 | 下载 | | 020571 | 023 | AP | Label | 2004/12/08 | 下载 | | 020571 | 021 | AP | Review | 2005/04/05 | 下载 | | 020571 | 021 | AP | Letter | 2004/06/25 | 下载 | | 020571 | 021 | AP | Label | 2004/06/25 | 下载 | | 020571 | 016 | AP | Letter | 2002/05/16 | 下载 | | 020571 | 016 | AP | Label | 2002/05/16 | 下载 | | 020571 | 009 | AP | Review | 2000/04/20 | 下载 | | 020571 | 009 | AP | Letter | 2000/04/20 | 下载 | | 020571 | 009 | AP | Label | 2000/04/20 | 下载 | | 020571 | 008 | AP | Letter | 1998/10/22 | 下载 | | 020571 | 008 | AP | Review | 1998/10/22 | 下载 | | 020571 | 008 | AP | Label | 1998/10/22 | 下载 | | 020571 | 007 | AP | Review | 2007/07/06 | 下载 | | 020571 | 006 | 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 | | 020571 | 048 | AP | 2014/12/19 | Labeling Revision | | 020571 | 047 | AP | 2014/06/09 | Manufacturing Change or Addition | | 020571 | 044 | AP | 2013/01/17 | Manufacturing Change or Addition | | 020571 | 042 | AP | 2012/07/13 | Labeling Revision | | 020571 | 037 | AP | 2010/05/14 | Labeling Revision | | 020571 | 036 | AP | 2010/05/14 | Labeling Revision | | 020571 | 033 | AP | 2010/05/14 | Labeling Revision | | 020571 | 032 | AP | 2010/05/14 | Labeling Revision | | 020571 | 031 | AP | 2010/05/14 | Labeling Revision | | 020571 | 030 | AP | 2006/08/01 | Labeling Revision | | 020571 | 028 | AP | 2005/07/21 | Labeling Revision | | 020571 | 027 | AP | 2005/07/21 | Labeling Revision | | 020571 | 026 | AP | 2005/06/07 | Labeling Revision | | 020571 | 024 | AP | 2005/07/21 | Labeling Revision | | 020571 | 023 | AP | 2004/12/03 | Labeling Revision | | 020571 | 021 | AP | 2004/06/24 | Efficacy Supplement with Clinical Data to Support | | 020571 | 017 | AP | 2002/07/30 | Manufacturing Change or Addition | | 020571 | 016 | AP | 2002/05/16 | Labeling Revision | | 020571 | 014 | AP | 2001/11/05 | Control Supplement | | 020571 | 013 | AP | 2001/08/06 | Control Supplement | | 020571 | 011 | AP | 2000/07/29 | Manufacturing Change or Addition | | 020571 | 009 | AP | 2000/04/20 | New or Modified Indication | | 020571 | 008 | AP | 1998/10/22 | Accelerated Approval | | 020571 | 007 | AP | 1998/03/18 | Labeling Revision | | 020571 | 006 | AP | 1998/01/15 | Formulation Revision | | 020571 | 005 | AP | 1997/10/21 | Control Supplement | | 020571 | 004 | AP | 1997/03/07 | Labeling Revision | | 020571 | 003 | AP | 1997/06/05 | Package Change | | 020571 | 002 | AP | 1997/12/10 | Control Supplement | | 020571 | 001 | AP | 1997/01/03 | Labeling Revision | | 020571 | 000 | AP | 1996/06/14 | Approval |
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