药品名称LANTUS
申请号021081产品号001
活性成分INSULIN GLARGINE RECOMBINANT市场状态处方药
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2000/04/20申请机构SANOFI AVENTIS US LLC
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
79188332027/09/23YPDF格式
77139302023/06/13YPDF格式
74766522023/07/23YPDF格式
7476652*PED2024/01/23PDF格式
7713930*PED2023/12/13PDF格式
7918833*PED2028/03/23PDF格式
历史专利信息
56567222014/08/12YYU-948PDF格式
56567222014/09/12PDF格式
5656722*PED2015/02/12PDF格式
5656722*PED2015/03/12PDF格式
61003762009/11/06YYU-771PDF格式
6100376*PED2010/05/06PDF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
021081063APLetter2015/07/20下载
021081063APLabel2015/07/22下载
021081062APLetter2015/02/27下载
021081062APLabel2015/03/03下载
021081057APLetter2013/10/22下载
021081057APLabel2013/10/22下载
021081055APLetter2013/05/17下载
021081055APLabel2013/05/21下载
021081034APReview2012/11/09下载
021081034APLabel2009/09/18下载
021081034APLetter2009/11/09下载
021081024APLabel2007/05/01下载
021081024APLetter2007/05/01下载
021081024APReview2013/01/24下载
021081017APLetter2005/03/18下载
021081017APLabel2005/03/18下载
021081017APReview2009/09/17下载
021081014APLetter2005/02/17下载
021081014APLabel2005/02/17下载
021081011APLetter2004/08/11下载
021081011APLabel2004/08/11下载
021081005APLabel2003/05/06下载
021081005APLetter2003/05/30下载
021081000APLetter2000/04/20下载
021081000APLabel2000/04/20下载
021081000APReview2002/03/18下载
021081000APOther Important Information from FDA2011/11/09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
021081065AP2016/04/13Manufacturing Change or Addition
021081064AP2015/06/16Manufacturing Change or Addition
021081063AP2015/07/17Efficacy Supplement with Clinical Data to Support
021081062AP2015/02/25Labeling Revision
021081061AP2014/09/05Manufacturing Change or Addition
021081059AP2013/06/05Manufacturing Change or Addition
021081058AP2013/07/18Manufacturing Change or Addition
021081057AP2013/10/18Efficacy Supplement with Clinical Data to Support
021081056AP2013/03/27Manufacturing Change or Addition
021081055AP2013/05/16Labeling Revision
021081049AP2013/08/14Manufacturing Change or Addition
021081034AP2009/09/09Efficacy Supplement with Clinical Data to Support
021081024AP2007/04/25Package Change
021081017AP2005/03/15Formulation Revision
021081014AP2005/02/11Package Change
021081011AP2004/08/10Package Change
021081005AP2003/05/01New Dosage Regimen
021081004AP2002/08/15Control Supplement
021081003AP2001/01/31Control Supplement
021081002AP2001/03/07Manufacturing Change or Addition
021081001AP2000/11/17Control Supplement
021081000AP2000/04/20Approval