药品名称HUMALOG MIX 50/50 PEN
申请号021018产品号003
活性成分INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT市场状态停止上市
剂型或给药途径INJECTABLE;INJECTION规格50 UNITS/ML;50 UNITS/ML
治疗等效代码参比药物
批准日期1999/12/22申请机构ELI LILLY AND CO
化学类型审评分类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
021018100APLetter2015/02/27下载
021018100APLabel2015/03/02下载
021018077APLetter2013/01/31下载
021018077APLabel2013/02/01下载
021018069APLabel2011/11/16下载
021018067APLabel2013/03/11下载
021018067APLetter2013/03/12下载
021018049APLabel2009/03/17下载
021018049APLetter2009/03/23下载
021018041APLabel2007/08/23下载
021018041APLetter2007/08/27下载
021018035APLetter2008/05/07下载
021018034APLetter2007/09/11下载
021018034APLabel2007/09/11下载
021018023APLetter2007/09/11下载
021018011APLetter2003/11/25下载
021018011APLabel2003/12/02下载
021018000APLetter1999/12/22下载
021018000APLabel1999/12/22下载
021018000APReview1999/12/22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
021018112AP2016/10/14Manufacturing Change or Addition
021018100AP2015/02/25Labeling Revision
021018096AP2014/09/12Manufacturing Change or Addition
021018095AP2014/06/04Manufacturing Change or Addition
021018093AP2014/04/11Manufacturing Change or Addition
021018092AP2014/04/03Manufacturing Change or Addition
021018091AP2014/01/24Manufacturing Change or Addition
021018090AP2014/03/18Manufacturing Change or Addition
021018088AP2013/08/15Manufacturing Change or Addition
021018085AP2013/03/28Manufacturing Change or Addition
021018081AP2013/02/15Manufacturing Change or Addition
021018077AP2013/01/30Labeling Revision
021018069AP2011/10/30Labeling Revision
021018067AP2013/03/11Labeling Revision
021018056AP2012/03/21Manufacturing Change or Addition
021018049AP2009/03/16Control Supplement
021018041AP2007/08/22Labeling Revision
021018035AP2008/05/01Labeling Revision
021018034AP2007/09/06Package Change
021018023AP2007/09/07Labeling Revision
021018011AP2003/11/19Manufacturing Change or Addition
021018004AP2002/10/25Control Supplement
021018003AP2002/04/05Control Supplement
021018002AP2002/03/21Control Supplement
021018001AP2002/02/08Labeling Revision
021018000AP1999/12/22Approval