药品名称NOVOLIN N
申请号019959产品号001
活性成分INSULIN SUSP ISOPHANE 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1991/07/01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
019959077APLetter2016/01/11下载
019959077APLabel2016/02/17下载
019959075APLetter2015/02/27下载
019959075APLabel2015/03/03下载
019959073APLetter2013/03/12下载
019959073APLabel2013/03/12下载
019959071APLetter2010/06/29下载
019959070APLetter2011/01/04下载
019959069APLetter2010/06/29下载
019959067APLabel2009/07/23下载
019959067APLetter2009/07/24下载
019959066APLetter2009/06/18下载
019959066APLabel2009/06/22下载
019959036APLabel2003/04/17下载
019959035APLetter2002/04/15下载
019959035APLabel2002/04/15下载
019959034APLetter2002/04/11下载
019959034APLabel2002/04/11下载
019959031APLetter2002/03/11下载
019959031APLabel2002/03/11下载
019959021APReview1997/04/16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
019959077AP2016/01/08Labeling Revision
019959075AP2015/02/25Labeling Revision
019959073AP2013/03/09Labeling Revision
019959071AP2010/06/25Labeling Revision
019959070AP2010/12/27Labeling Revision
019959069AP2010/06/25Manufacturing Change or Addition
019959067AP2009/07/17Control Supplement
019959066AP2009/06/15Labeling Revision
019959039AP2002/06/19Manufacturing Change or Addition
019959038AP2002/01/10Control Supplement
019959036AP2001/12/19Package Change
019959035AP2002/04/15Package Change
019959034AP2002/04/11Package Change
019959033AP2001/01/09Control Supplement
019959032AP2000/12/13Control Supplement
019959031AP2002/03/11Labeling Revision
019959030AP2001/12/17Labeling Revision
019959029AP2001/02/21Control Supplement
019959028AP2000/06/15Labeling Revision
019959027AP2000/04/10Control Supplement
019959026AP2000/03/16Package Change
019959025AP1999/10/18Manufacturing Change or Addition
019959024AP1998/07/24Control Supplement
019959023AP1997/08/04Control Supplement
019959022AP1997/06/20Package Change
019959021AP1997/04/16Labeling Revision
019959020AP1997/01/02Control Supplement
019959019AP1997/04/10Labeling Revision
019959018AP1996/08/08Manufacturing Change or Addition
019959017AP1997/01/28Control Supplement
019959016AP1995/05/22Control Supplement
019959015AP1994/01/04Labeling Revision
019959014AP1994/01/03Labeling Revision
019959013AP1994/06/23Package Change
019959012AP1994/06/23Control Supplement
019959011AP1994/06/16Control Supplement
019959010AP1994/05/31Control Supplement
019959009AP1994/05/23Control Supplement
019959008AP1994/04/26Control Supplement
019959007AP1994/01/07Labeling Revision
019959006AP1993/03/26Labeling Revision
019959004AP1993/03/26Control Supplement
019959002AP1992/03/13Control Supplement
019959001AP1991/10/07Control Supplement
019959000AP1991/07/01Approval