药品名称NOVOLOG MIX 70/30 PENFILL
申请号021172产品号002
活性成分INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT市场状态停止上市
剂型或给药途径INJECTABLE;SUBCUTANEOUS规格210 UNITS/3ML;90 UNITS/3ML (70 UNITS/ML; 30 UNITS/ML)
治疗等效代码参比药物
批准日期2001/11/01申请机构NOVO NORDISK INC
化学类型New combination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
58665382017/06/19YPDF格式
5866538*PED2017/12/19PDF格式
历史专利信息
55479302013/09/28YYPDF格式
56189132014/06/07YYPDF格式
5618913*PED2014/12/07PDF格式
58344222013/09/28YU-471PDF格式
58406802013/09/28YYU-471PDF格式
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
021172064APLetter2015/04/20下载
021172064APLabel2015/04/22下载
021172063APLetter2015/02/27下载
021172063APLabel2015/03/03下载
021172053APLetter2013/03/12下载
021172053APLabel2013/03/12下载
021172051APLabel2012/12/18下载
021172051APLetter2012/12/19下载
021172049APLetter2010/05/12下载
021172049APLabel2010/05/17下载
021172046APLetter2015/02/27下载
021172046APLabel2015/03/03下载
021172045APLetter2010/05/12下载
021172045APLabel2010/05/17下载
021172044APLetter2009/05/13下载
021172043APLetter2008/11/28下载
021172039APLetter2008/09/09下载
021172038APLetter2008/09/09下载
021172034APLetter2007/07/24下载
021172034APLabel2007/07/24下载
021172023APLetter2005/11/18下载
021172023APLabel2005/11/18下载
021172021APLabel2005/11/30下载
021172021APLetter2005/11/30下载
021172013APLetter2004/10/15下载
021172013APLabel2004/10/15下载
021172009APLetter2002/11/18下载
021172009APLabel2002/11/18下载
021172003APLetter2002/06/26下载
021172003APLabel2002/06/26下载
021172001APLetter2002/05/03下载
021172001APLabel2002/05/03下载
021172000APLetter2001/11/01下载
021172000APLabel2001/11/01下载
021172000APReview2001/11/01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
021172064AP2015/04/17Labeling Revision
021172063AP2015/02/25Labeling Revision
021172061AP2014/09/04Manufacturing Change or Addition
021172053AP2013/03/09Labeling Revision
021172051AP2012/12/13Labeling Revision
021172049AP2010/05/07Efficacy Supplement with Clinical Data to Support
021172046AP2015/02/25Labeling Revision
021172045AP2010/05/07New Dosage Regimen
021172044AP2009/05/07Labeling Revision
021172043AP2008/11/28Labeling Revision
021172039AP2008/09/03Labeling Revision
021172038AP2008/09/03Labeling Revision
021172034AP2007/07/20Formulation Revision
021172023AP2005/11/15Labeling Revision
021172021AP2005/11/21Efficacy Supplement with Clinical Data to Support
021172013AP2004/10/08Labeling Revision
021172011AP2002/12/04Control Supplement
021172010AP2002/11/19Control Supplement
021172009AP2002/11/18Package Change
021172008AP2002/07/29Control Supplement
021172007AP2002/03/05Control Supplement
021172006AP2002/02/25Manufacturing Change or Addition
021172005AP2002/02/25Control Supplement
021172004AP2002/02/25Manufacturing Change or Addition
021172003AP2002/06/26Formulation Revision
021172002AP2002/02/25Manufacturing Change or Addition
021172001AP2002/05/03Package Change
021172000AP2001/11/01Approval