药品名称 | GLIADEL | 申请号 | 020637 | 产品号 | 001 | 活性成分 | CARMUSTINE | 市场状态 | 处方药 | 剂型或给药途径 | IMPLANT;INTRACRANIAL | 规格 | 7.7MG | 治疗等效代码 | | 参比药物 | 是 | 批准日期 | 1996/09/23 | 申请机构 | ARBOR PHARMACEUTICALS LLC
| 化学类型 | New dosage form | 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 | ODE | 2010/02/25 |
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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 | 020637 | 027 | AP | Letter | 2014/11/24 | 下载 | 020637 | 026 | AP | Letter | 2013/08/20 | 下载 | 020637 | 026 | AP | Label | 2013/08/21 | 下载 | 020637 | 022 | AP | Letter | 2007/01/08 | 下载 | 020637 | 016 | AP | Label | 2003/03/05 | 下载 | 020637 | 016 | AP | Letter | 2003/03/10 | 下载 | 020637 | 016 | AP | Review | 2003/07/08 | 下载 | 020637 | 000 | AP | Review | 2013/02/25 | 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 | 020637 | 028 | AP | 2015/06/01 | Manufacturing Change or Addition | 020637 | 027 | AP | 2014/11/20 | Labeling Revision | 020637 | 026 | AP | 2013/08/16 | Labeling Revision | 020637 | 022 | AP | 2006/12/27 | Labeling Revision | 020637 | 017 | AP | 2001/11/07 | Manufacturing Change or Addition | 020637 | 016 | AP | 2003/02/25 | New or Modified Indication | 020637 | 015 | AP | 2001/05/15 | Manufacturing Change or Addition | 020637 | 014 | AP | 2000/08/08 | Control Supplement | 020637 | 013 | AP | 1999/10/25 | Manufacturing Change or Addition | 020637 | 012 | AP | 1999/07/16 | Control Supplement | 020637 | 011 | AP | 2000/09/27 | Control Supplement | 020637 | 010 | AP | 1999/03/25 | Control Supplement | 020637 | 009 | AP | 1999/02/10 | Manufacturing Change or Addition | 020637 | 008 | AP | 1998/10/16 | Control Supplement | 020637 | 007 | AP | 1998/02/12 | Control Supplement | 020637 | 006 | AP | 1998/01/22 | Control Supplement | 020637 | 004 | AP | 1997/08/22 | Control Supplement | 020637 | 003 | AP | 1997/09/15 | Control Supplement | 020637 | 002 | AP | 1997/04/04 | Control Supplement | 020637 | 001 | AP | 1996/10/08 | Manufacturing Change or Addition | 020637 | 000 | AP | 1996/09/23 | Approval |
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