药品名称NOVOLIN R
申请号019938产品号001
活性成分INSULIN RECOMBINANT HUMAN市场状态非处方药
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1991/06/25申请机构NOVO NORDISK INC
化学类型New formulation or new manufacturer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
019938074APLetter2016/01/11下载
019938074APLabel2016/01/12下载
019938072APLabel2013/02/08下载
019938072APLetter2013/02/08下载
019938071APLetter2013/03/12下载
019938071APLabel2013/03/12下载
019938069APLetter2010/06/29下载
019938068APLetter2011/01/04下载
019938067APLetter2010/06/29下载
019938066APLabel2012/02/27下载
019938066APLetter2012/02/29下载
019938064APLabel2009/07/23下载
019938064APLetter2009/07/24下载
019938063APLetter2009/06/18下载
019938063APLabel2009/06/22下载
019938048APLabel2005/10/25下载
019938037APLabel2005/11/22下载
019938037APLetter2005/11/22下载
019938033APLetter2002/04/15下载
019938033APLabel2002/04/15下载
019938032APLetter2002/04/11下载
019938032APLabel2002/04/11下载
019938030APLetter2002/03/11下载
019938030APLabel2002/03/11下载
019938020APReview1997/11/20下载
019938019APReview1997/04/10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
019938074AP2016/01/08Labeling Revision
019938073AP2015/12/01Manufacturing Change or Addition
019938072AP2013/02/07Labeling Revision
019938071AP2013/03/09Labeling Revision
019938069AP2010/06/25Labeling Revision
019938068AP2010/12/27Labeling Revision
019938067AP2010/06/25Manufacturing Change or Addition
019938066AP2012/02/27Labeling Revision
019938064AP2009/07/17Control Supplement
019938063AP2009/06/15Labeling Revision
019938048AP2005/10/21Supplement
019938037AP2005/11/18Labeling Revision
019938036AP2002/06/19Manufacturing Change or Addition
019938035AP2002/01/10Control Supplement
019938034AP2001/12/19Package Change
019938033AP2002/04/15Package Change
019938032AP2002/04/11Package Change
019938031AP2001/01/09Control Supplement
019938030AP2002/03/11Labeling Revision
019938029AP2001/12/10Labeling Revision
019938027AP2000/06/15Labeling Revision
019938026AP2000/04/10Control Supplement
019938025AP2000/03/16Package Change
019938024AP1999/10/18Manufacturing Change or Addition
019938023AP1998/07/24Control Supplement
019938022AP1997/08/04Control Supplement
019938021AP1997/06/20Package Change
019938020AP1997/04/16Labeling Revision
019938019AP1997/04/10Labeling Revision
019938018AP1996/06/13Manufacturing Change or Addition
019938017AP1997/01/28Control Supplement
019938016AP1995/08/16Control Supplement
019938015AP1995/05/22Control Supplement
019938014AP1994/01/04Labeling Revision
019938013AP1994/01/03Labeling Revision
019938012AP1994/06/23Package Change
019938011AP1994/06/23Control Supplement
019938010AP1994/06/16Control Supplement
019938009AP1994/05/31Control Supplement
019938008AP1994/05/23Control Supplement
019938007AP1994/04/26Control Supplement
019938006AP1994/01/07Labeling Revision
019938005AP1993/03/26Labeling Revision
019938003AP1993/03/26Control Supplement
019938002AP1992/03/13Control Supplement
019938001AP1991/10/07Control Supplement
019938000AP1991/06/25Approval