药品名称SUFENTA PRESERVATIVE FREE
申请号019050产品号001
活性成分SUFENTANIL 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1984/05/04申请机构AKORN INC
化学类型New molecular entity (NME)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
019050032APLetter2014/03/21下载
019050032APLabel2014/03/25下载
019050031APLetter2007/06/07下载
019050031APLabel2007/06/07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
019050032AP2014/03/20Labeling Revision
019050031AP2007/06/04Labeling Revision
019050028AP1999/05/25Control Supplement
019050027AP1998/05/26Control Supplement
019050026AP1998/05/01Manufacturing Change or Addition
019050025AP2001/08/27Labeling Revision
019050024AP1996/06/21Labeling Revision
019050023AP1997/08/12Control Supplement
019050022AP1995/02/22Manufacturing Change or Addition
019050021AP1992/11/10Manufacturing Change or Addition
019050020AP1994/03/23Manufacturing Change or Addition
019050019AP1994/03/23Package Change
019050018AP1994/03/23Control Supplement
019050017AP1993/03/19New Route of Administration
019050014AP1990/10/05Control Supplement
019050011AP1987/04/29Expiration Date Change
019050010AP1986/11/14Labeling Revision
019050009AP1986/11/14Manufacturing Change or Addition
019050008AP1986/08/06Control Supplement
019050007AP1986/03/18Control Supplement
019050006AP1986/03/18Labeling Revision
019050004AP1986/06/20Control Supplement
019050003AP1985/08/21Labeling Revision
019050002AP1985/08/21Control Supplement
019050001AP1984/09/10Control Supplement
019050000AP1984/05/04Approval