药品名称ETHAMOLIN
申请号019357产品号001
活性成分ETHANOLAMINE OLEATE市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格50MG/ML
治疗等效代码参比药物
批准日期1988/12/22申请机构QOL MEDICAL LLC
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
历史专利信息
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
019357014APLetter2002/02/05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
019357020AP2013/09/05Manufacturing Change or Addition
019357018AP2014/02/07Manufacturing Change or Addition
019357015AP2002/09/20Manufacturing Change or Addition
019357014AP2002/02/05Labeling Revision
019357013AP2001/04/20Manufacturing Change or Addition
019357012AP1998/06/16Manufacturing Change or Addition
019357011AP1998/06/16Manufacturing Change or Addition
019357010AP1997/01/03Manufacturing Change or Addition
019357009AP1996/10/01Manufacturing Change or Addition
019357008AP1993/01/29Labeling Revision
019357007AP1992/09/15Control Supplement
019357006AP1993/01/29Manufacturing Change or Addition
019357005AP1992/08/26Control Supplement
019357004AP1992/06/03Control Supplement
019357003AP1992/04/10Manufacturing Change or Addition
019357001AP1991/01/18Labeling Revision
019357000AP1988/12/22Approval