药品名称NOVOLOG INNOLET
申请号020986产品号004
活性成分INSULIN ASPART RECOMBINANT市场状态停止上市
剂型或给药途径INJECTABLE;SUBCUTANEOUS规格300 UNITS/3ML (100 UNITS/ML)
治疗等效代码参比药物
批准日期2004/04/23申请机构NOVO NORDISK INC
化学类型New molecular entity (NME)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
58665382017/06/20YPDF格式
RE419562021/01/21YPDF格式
5866538*PED2017/12/20PDF格式
RE41956*PED2021/07/21PDF格式
历史专利信息
56189132014/06/07YYPDF格式
5618913*PED2014/12/07PDF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
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020986084APLabel2016/10/12下载
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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
020986084AP2016/10/07Labeling Revision
020986082AP2015/04/17Labeling Revision
020986081AP2015/02/25Labeling Revision
020986080AP2015/01/23Labeling Revision
020986078AP2015/01/14Efficacy Supplement with Clinical Data to Support
020986077AP2014/09/04Manufacturing Change or Addition
020986076AP2014/09/04Manufacturing Change or Addition
020986075AP2014/02/25Labeling Revision
020986074AP2014/03/04Manufacturing Change or Addition
020986067AP2013/03/09Labeling Revision
020986064AP2012/12/13Labeling Revision
020986062AP2012/11/28Labeling Revision
020986061AP2013/10/31Labeling Revision
020986060AP2010/06/25Labeling Revision
020986059AP2015/02/25Labeling Revision
020986058AP2010/06/25Manufacturing Change or Addition
020986057AP2012/11/05Labeling Revision
020986055AP2009/07/17Control Supplement
020986054AP2009/05/07Labeling Revision
020986053AP2008/11/28Labeling Revision
020986050AP2008/09/03Labeling Revision
020986049AP2008/09/03Labeling Revision
020986047AP2008/03/14Patient Population Altered
020986045AP2009/07/14Expiration Date Change
020986040AP2006/10/27Manufacturing Change or Addition
020986037AP2007/01/26Efficacy Supplement with Clinical Data to Support
020986033AP2005/09/13Patient Population Altered
020986032AP2005/10/21Supplement
020986024AP2004/07/30Labeling Revision
020986023AP2004/04/23Package Change
020986020AP2004/03/19Labeling Revision
020986019AP2004/10/08Labeling Revision
020986016AP2002/12/04Control Supplement
020986015AP2002/11/19Control Supplement
020986011AP2002/12/04Efficacy Supplement with Clinical Data to Support
020986010AP2002/07/29Control Supplement
020986009AP2002/03/05Control Supplement
020986008AP2001/11/20Manufacturing Change or Addition
020986007AP2001/07/27Manufacturing Change or Addition
020986006AP2001/08/31Control Supplement
020986005AP2001/06/26Manufacturing Change or Addition
020986004AP2002/04/11Package Change
020986003AP2001/12/21New Route of Administration
020986002AP2002/04/11Package Change
020986001AP2001/01/19Control Supplement
020986000AP2000/06/07Approval