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
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
与本品相关的专利信息(来自橙皮书Orange Book)
专利号专利过期日是否化合物专利是否产品专利专利用途代码专利下载
59944092017/12/08U-305PDF格式
历史专利信息
54244712012/07/31PDF格式
55917312012/07/31PDF格式
与本品相关的市场独占权保护信息
独占权代码失效日期
历史市场独占权保护信息
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
020221024APLabel2008/11/12下载
020221024APLetter2008/11/13下载
020221020APLetter2006/04/05下载
020221017APLabel2003/03/28下载
020221017APLetter2003/04/15下载
020221015APLetter2002/02/20下载
020221012APReview1999/06/24下载
020221012APLetter1999/06/24下载
020221012APLabel1999/06/24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
020221031AP2016/01/15Manufacturing Change or Addition
020221030AP2016/03/09Manufacturing Change or Addition
020221028AP2013/08/26Manufacturing Change or Addition
020221024AP2008/11/07Labeling Revision
020221020AP2006/03/28Labeling Revision
020221017AP2003/03/27Labeling Revision
020221015AP2002/02/20Labeling Revision
020221014AP1999/09/10Control Supplement
020221013AP1999/04/01Labeling Revision
020221012AP1999/06/24New or Modified Indication
020221011AP1999/02/11Control Supplement
020221010AP1999/03/11Labeling Revision
020221009AP1997/10/10Manufacturing Change or Addition
020221007AP1997/02/20Control Supplement
020221005AP1996/12/18Manufacturing Change or Addition
020221004AP1996/11/21Manufacturing Change or Addition
020221003AP1996/12/30Control Supplement
020221002AP1996/03/15New or Modified Indication
020221001AP1996/01/23Control Supplement
020221000AP1995/12/08Approval