药品名称SUBLIMAZE PRESERVATIVE FREE
申请号016619产品号001
活性成分FENTANYL CITRATE市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格EQ 0.05MG BASE/ML
治疗等效代码AP参比药物
批准日期Approved Prior to Jan 1, 1982申请机构AKORN INC
化学类型New dosage form审评分类Priority review drug
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
016619034APLabel2013/07/05下载
016619034APLetter2013/07/08下载
016619032APLetter2003/10/22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
016619037AP2016/05/18Manufacturing Change or Addition
016619034AP2013/07/03Labeling Revision
016619032AP2003/10/17Labeling Revision
016619031AP1996/04/26Labeling Revision
016619030AP1995/02/22Manufacturing Change or Addition
016619029AP1993/12/23Labeling Revision
016619028AP1993/12/23Package Change
016619027AP1993/12/23Manufacturing Change or Addition
016619026AP1993/12/23Control Supplement
016619025AP1992/10/28Manufacturing Change or Addition
016619024AP1992/12/07Control Supplement
016619023AP1990/07/05Control Supplement
016619022AP1989/09/14Manufacturing Change or Addition
016619021AP1991/11/25Control Supplement
016619020AP1987/01/27Labeling Revision
016619019AP1986/09/05Labeling Revision
016619018AP1986/09/05Control Supplement
016619017AP1985/09/10Practioner Draft Labeling
016619014AP1983/09/07Control Supplement
016619013AP1983/03/11Manufacturing Change or Addition
016619012AP1982/07/07Labeling Revision
016619011AP1982/07/07Control Supplement
016619010AP1981/02/24Labeling Revision
016619009AP1981/02/24Control Supplement
016619006AP1980/05/23Control Supplement
016619004AP1976/11/08Labeling Revision
016619000AP1968/02/19Approval