药品名称PENTAM
申请号019264产品号001
活性成分PENTAMIDINE ISETHIONATE市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格300MG/VIAL
治疗等效代码参比药物
批准日期1984/10/16申请机构FRESENIUS KABI USA LLC
化学类型New molecular entity (NME)审评分类
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
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
019264032AP2014/01/08Manufacturing Change or Addition
019264031AP2013/02/16Manufacturing Change or Addition
019264023AP2002/05/24Manufacturing Change or Addition
019264021AP1997/10/24Labeling Revision
019264019AP1997/02/26Labeling Revision
019264018AP1996/03/18Labeling Revision
019264017AP1994/06/08Control Supplement
019264016AP1994/05/31Control Supplement
019264015AP1996/08/27Labeling Revision
019264014AP1989/08/16Manufacturing Change or Addition
019264013AP1993/02/09Labeling Revision
019264012AP1988/11/14Package Change
019264008AP1987/06/12Control Supplement
019264007AP1986/10/24Manufacturing Change or Addition
019264006AP1986/10/24Manufacturing Change or Addition
019264005AP1986/10/24Manufacturing Change or Addition
019264004AP1987/04/09Labeling Revision
019264003AP1987/06/10Control Supplement
019264002AP1985/08/06Control Supplement
019264000AP1984/10/16Approval