药品名称HUMULIN U
申请号019571产品号002
活性成分INSULIN ZINC SUSP EXTENDED RECOMBINANT HUMAN市场状态停止上市
剂型或给药途径INJECTABLE;INJECTION规格100 UNITS/ML
治疗等效代码参比药物
批准日期1987/06/10申请机构ELI LILLY AND CO
化学类型New dosage form审评分类Standard 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
019571037APLabel2006/01/10下载
019571037APLetter2006/01/20下载
019571029APLabel2003/05/29下载
019571029APLetter2003/05/29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
019571037AP2006/01/09Labeling Revision
019571029AP2003/04/18Manufacturing Change or Addition
019571027AP2002/08/29Control Supplement
019571026AP2002/08/29Control Supplement
019571025AP2002/08/29Control Supplement
019571024AP2002/08/21Control Supplement
019571023AP2002/08/21Control Supplement
019571022AP2002/04/02Control Supplement
019571019AP1997/07/16Control Supplement
019571018AP1996/07/26Control Supplement
019571017AP1996/05/22Control Supplement
019571016AP1996/04/25Manufacturing Change or Addition
019571015AP1995/03/09Control Supplement
019571014AP1995/02/22Labeling Revision
019571013AP1995/02/10Manufacturing Change or Addition
019571012AP1992/12/07Package Change
019571011AP1992/01/27Labeling Revision
019571010AP1991/03/12Labeling Revision
019571009AP1990/09/24Control Supplement
019571008AP1990/08/17Control Supplement
019571007AP1989/05/24Control Supplement
019571006AP1989/01/23Labeling Revision
019571005AP1988/07/29Control Supplement
019571004AP1988/03/24Labeling Revision
019571003AP1987/10/27Control Supplement
019571002AP1987/10/27Manufacturing Change or Addition
019571000AP1987/06/10Approval