| 药品名称 | CASODEX | | 申请号 | 020498 | 产品号 | 001 | | 活性成分 | BICALUTAMIDE | 市场状态 | 处方药 | | 剂型或给药途径 | TABLET;ORAL | 规格 | 50MG | | 治疗等效代码 | AB | 参比药物 | 是 | | 批准日期 | 1995/10/04 | 申请机构 | ASTRAZENECA UK LTD
| | 化学类型 | New molecular entity (NME) | 审评分类 | Standard review drug |
|
|
|
| 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-81 | 2011/12/19 | | PED | 2012/06/19 |
|
| 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 | | 020498 | 025 | AP | Letter | 2015/03/02 | 下载 | | 020498 | 025 | AP | Label | 2015/03/04 | 下载 | | 020498 | 022 | AP | Letter | 2010/09/20 | 下载 | | 020498 | 022 | AP | Label | 2010/09/20 | 下载 | | 020498 | 021 | AP | Label | 2009/02/12 | 下载 | | 020498 | 021 | AP | Letter | 2009/03/16 | 下载 | | 020498 | 019 | AP | Letter | 2009/03/16 | 下载 | | 020498 | 019 | AP | Label | 2009/02/12 | 下载 | | 020498 | 018 | AP | Label | 2006/03/14 | 下载 | | 020498 | 018 | AP | Letter | 2006/03/23 | 下载 | | 020498 | 016 | AP | Letter | 2005/05/17 | 下载 | | 020498 | 016 | AP | Label | 2005/05/17 | 下载 |
|
| 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 | | 020498 | 025 | AP | 2015/02/27 | Labeling Revision | | 020498 | 024 | AP | 2013/09/12 | Manufacturing Change or Addition | | 020498 | 022 | AP | 2010/09/15 | Labeling Revision | | 020498 | 021 | AP | 2009/02/10 | Labeling Revision | | 020498 | 019 | AP | 2009/02/10 | Labeling Revision | | 020498 | 018 | AP | 2006/03/10 | Labeling Revision | | 020498 | 016 | AP | 2005/05/11 | Labeling Revision | | 020498 | 013 | AP | 2002/09/23 | Manufacturing Change or Addition | | 020498 | 011 | AP | 2002/01/25 | Control Supplement | | 020498 | 010 | AP | 2001/10/25 | Manufacturing Change or Addition | | 020498 | 008 | AP | 2001/02/28 | Labeling Revision | | 020498 | 007 | AP | 2000/12/11 | Manufacturing Change or Addition | | 020498 | 005 | AP | 1999/11/04 | Manufacturing Change or Addition | | 020498 | 004 | AP | 1997/12/12 | New or Modified Indication | | 020498 | 003 | AP | 1997/11/12 | Control Supplement | | 020498 | 000 | AP | 1995/10/04 | Approval |
|