| 药品名称 | ETHYOL | | 申请号 | 020221 | 产品号 | 001 | | 活性成分 | AMIFOSTINE | 市场状态 | 处方药 | | 剂型或给药途径 | INJECTABLE;INJECTION | 规格 | 500MG/VIAL | | 治疗等效代码 | AP | 参比药物 | 是 | | 批准日期 | 1995/12/08 | 申请机构 | CLINIGEN HEALTHCARE LTD
| | 化学类型 | New molecular entity (NME) | 审评分类 | Priority review drug | | 罕用药/孤儿药 | 是 | | |
|
|
|
| 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 |
|
| 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 | | 020221 | 024 | AP | Label | 2008/11/12 | 下载 | | 020221 | 024 | AP | Letter | 2008/11/13 | 下载 | | 020221 | 020 | AP | Letter | 2006/04/05 | 下载 | | 020221 | 017 | AP | Label | 2003/03/28 | 下载 | | 020221 | 017 | AP | Letter | 2003/04/15 | 下载 | | 020221 | 015 | AP | Letter | 2002/02/20 | 下载 | | 020221 | 012 | AP | Review | 1999/06/24 | 下载 | | 020221 | 012 | AP | Letter | 1999/06/24 | 下载 | | 020221 | 012 | AP | Label | 1999/06/24 | 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 | | 020221 | 031 | AP | 2016/01/15 | Manufacturing Change or Addition | | 020221 | 030 | AP | 2016/03/09 | Manufacturing Change or Addition | | 020221 | 028 | AP | 2013/08/26 | Manufacturing Change or Addition | | 020221 | 024 | AP | 2008/11/07 | Labeling Revision | | 020221 | 020 | AP | 2006/03/28 | Labeling Revision | | 020221 | 017 | AP | 2003/03/27 | Labeling Revision | | 020221 | 015 | AP | 2002/02/20 | Labeling Revision | | 020221 | 014 | AP | 1999/09/10 | Control Supplement | | 020221 | 013 | AP | 1999/04/01 | Labeling Revision | | 020221 | 012 | AP | 1999/06/24 | New or Modified Indication | | 020221 | 011 | AP | 1999/02/11 | Control Supplement | | 020221 | 010 | AP | 1999/03/11 | Labeling Revision | | 020221 | 009 | AP | 1997/10/10 | Manufacturing Change or Addition | | 020221 | 007 | AP | 1997/02/20 | Control Supplement | | 020221 | 005 | AP | 1996/12/18 | Manufacturing Change or Addition | | 020221 | 004 | AP | 1996/11/21 | Manufacturing Change or Addition | | 020221 | 003 | AP | 1996/12/30 | Control Supplement | | 020221 | 002 | AP | 1996/03/15 | New or Modified Indication | | 020221 | 001 | AP | 1996/01/23 | Control Supplement | | 020221 | 000 | AP | 1995/12/08 | Approval |
|