药品名称NOVOLOG FLEXPEN
申请号020986产品号003
活性成分INSULIN ASPART RECOMBINANT市场状态处方药
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2001/01/19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
92658932032/09/23YPDF格式
58665382017/06/20YPDF格式
RE419562021/01/21YPDF格式
60042972019/01/28YPDF格式
RE438342019/01/28YPDF格式
5866538*PED2017/12/20PDF格式
6004297*PED2019/07/28PDF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
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
020986084APLabel2016/10/12下载
020986084APLetter2016/10/14下载
020986082APLetter2015/04/20下载
020986082APLabel2015/04/23下载
020986081APLetter2015/02/27下载
020986081APLabel2015/03/03下载
020986080APLetter2015/01/26下载
020986080APLabel2015/01/29下载
020986078APLabel2015/01/15下载
020986078APLetter2015/01/16下载
020986075APLetter2014/02/27下载
020986067APLetter2013/03/12下载
020986067APLabel2013/03/12下载
020986064APLabel2012/12/18下载
020986064APLetter2012/12/19下载
020986062APLetter2012/11/29下载
020986061APReview2014/07/07下载
020986061APLabel2013/11/01下载
020986061APLetter2013/11/06下载
020986060APLetter2010/06/29下载
020986059APLetter2015/02/27下载
020986059APLabel2015/03/03下载
020986058APLetter2010/06/29下载
020986057APLabel2012/11/05下载
020986057APLetter2012/11/07下载
020986055APLabel2009/07/23下载
020986055APLetter2009/07/24下载
020986054APLetter2009/05/13下载
020986053APLetter2008/11/28下载
020986050APLetter2008/09/09下载
020986049APLetter2008/09/09下载
020986047APLabel2008/03/17下载
020986047APLetter2008/03/18下载
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020986037APLetter2007/02/12下载
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020986032APLabel2005/11/01下载
020986024APLetter2004/08/02下载
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020986020APLetter2004/03/24下载
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020986011APLetter2002/12/04下载
020986011APLabel2002/12/04下载
020986004APLetter2002/04/11下载
020986004APLabel2002/04/11下载
020986003APLetter2001/12/21下载
020986003APLabel2001/12/21下载
020986003APReview2001/12/21下载
020986002APLetter2002/04/11下载
020986002APLabel2002/04/11下载
020986000APReview2000/06/07下载
020986000APLetter2000/06/07下载
020986000APLabel2000/06/07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
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