药品名称HUMALOG PEN
申请号020563产品号002
活性成分INSULIN LISPRO RECOMBINANT市场状态停止上市
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1998/08/06申请机构ELI LILLY AND CO
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
历史专利信息
54749782014/06/16U-534PDF格式
55146462013/05/07U-534PDF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
NR2015/10/12
历史市场独占权保护信息
D-862007/06/02
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
020563163APLetter2015/06/15下载
020563163APLabel2015/06/15下载
020563157APLetter2015/02/27下载
020563157APLabel2015/03/02下载
020563127APLetter2013/01/31下载
020563127APLabel2013/02/01下载
020563124APLetter2015/03/16下载
020563124APLabel2015/04/07下载
020563123APLabel2012/10/15下载
020563123APLetter2012/10/16下载
020563117APLabel2011/11/16下载
020563115APLabel2013/03/11下载
020563115APLetter2013/03/13下载
020563105APLetter2011/05/24下载
020563105APLabel2011/05/23下载
020563098APLetter2011/05/24下载
020563098APLabel2011/05/23下载
020563091APLabel2009/03/17下载
020563091APLetter2009/03/23下载
020563082APLetter2007/07/24下载
020563082APLabel2007/07/24下载
020563076APLabel2007/06/27下载
020563076APLetter2007/07/05下载
020563075APLabel2007/09/11下载
020563075APLetter2007/09/11下载
020563065APLabel2007/08/23下载
020563065APLetter2007/08/27下载
020563064APLetter2007/09/11下载
020563054APLetter2005/05/23下载
020563054APLabel2005/05/23下载
020563046APLetter2004/04/29下载
020563046APLabel2004/05/04下载
020563044APLabel2004/06/07下载
020563044APLetter2003/11/25下载
020563041APLabel2003/10/08下载
020563041APLetter2003/10/09下载
020563040APLetter2003/07/06下载
020563040APLabel2003/07/08下载
020563036APLetter2004/01/22下载
020563036APLabel2004/01/22下载
020563032APLabel2003/04/03下载
020563032APLetter2003/04/16下载
020563027APLabel2003/03/05下载
020563027APLetter2004/06/07下载
020563024APLetter2004/06/07下载
020563024APLabel2004/06/07下载
020563016APLetter2004/06/07下载
020563015APLabel2003/03/11下载
020563013APLetter2000/04/04下载
020563013APLabel2000/04/04下载
020563012APLetter2000/04/04下载
020563012APLabel2000/04/04下载
020563011APLetter2000/04/04下载
020563011APLabel2000/04/04下载
020563010APLetter2000/04/04下载
020563010APLabel2000/04/04下载
020563009APReview2007/07/09下载
020563003APReview1997/07/16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
020563171AP2016/10/17Manufacturing Change or Addition
020563170AP2016/09/22Manufacturing Change or Addition
020563163AP2015/06/12Labeling Revision
020563161AP2015/09/10Manufacturing Change or Addition
020563159AP2015/06/11Manufacturing Change or Addition
020563157AP2015/02/25Labeling Revision
020563156AP2015/01/26Manufacturing Change or Addition
020563155AP2014/11/11Manufacturing Change or Addition
020563152AP2014/09/12Manufacturing Change or Addition
020563150AP2014/06/04Manufacturing Change or Addition
020563149AP2014/04/11Manufacturing Change or Addition
020563148AP2014/04/03Manufacturing Change or Addition
020563147AP2014/04/01Manufacturing Change or Addition
020563146AP2014/01/24Manufacturing Change or Addition
020563145AP2014/03/18Manufacturing Change or Addition
020563144AP2014/03/04Manufacturing Change or Addition
020563143AP2014/01/31Manufacturing Change or Addition
020563142AP2013/08/15Manufacturing Change or Addition
020563141AP2013/07/18Manufacturing Change or Addition
020563139AP2013/08/21Manufacturing Change or Addition
020563137AP2013/03/28Manufacturing Change or Addition
020563135AP2013/03/14Manufacturing Change or Addition
020563134AP2013/05/10Manufacturing Change or Addition
020563133AP2013/09/06Manufacturing Change or Addition
020563132AP2013/02/15Manufacturing Change or Addition
020563131AP2013/06/12Manufacturing Change or Addition
020563127AP2013/01/30Labeling Revision
020563124AP2015/03/13Labeling Revision
020563123AP2012/10/12New Route of Administration
020563117AP2011/10/30Labeling Revision
020563115AP2013/03/11Labeling Revision
020563105AP2011/05/18Patient Population Altered
020563098AP2011/05/18Labeling Revision
020563091AP2009/03/16Control Supplement
020563082AP2007/07/20Labeling Revision
020563076AP2007/06/14Labeling Revision
020563075AP2007/09/06Package Change
020563065AP2007/08/22Labeling Revision
020563064AP2007/09/07Labeling Revision
020563060AP2005/11/09Labeling Revision
020563054AP2005/05/20Labeling Revision
020563051AP2014/07/31Manufacturing Change or Addition
020563046AP2004/04/21Labeling Revision
020563044AP2003/11/19Manufacturing Change or Addition
020563041AP2003/09/29Manufacturing Change or Addition
020563040AP2003/06/24Labeling Revision
020563036AP2004/01/16Labeling Revision
020563035AP2002/10/25New or Modified Indication
020563034AP2002/02/05Control Supplement
020563033AP2001/12/17Control Supplement
020563032AP2003/04/01Labeling Revision
020563030AP2001/05/11Manufacturing Change or Addition
020563029AP2001/03/26Control Supplement
020563028AP2000/09/11Control Supplement
020563027AP2003/03/12Labeling Revision
020563026AP2000/07/07Manufacturing Change or Addition
020563025AP2000/03/14Control Supplement
020563024AP2004/06/02New Route of Administration
020563023AP2000/05/23Manufacturing Change or Addition
020563021AP2000/02/25Manufacturing Change or Addition
020563020AP2000/01/11Manufacturing Change or Addition
020563017AP1999/05/12Control Supplement
020563016AP2003/01/02Labeling Revision
020563015AP1999/02/25Manufacturing Change or Addition
020563014AP1999/02/25Control Supplement
020563013AP2000/04/04Efficacy Supplement with Clinical Data to Support
020563012AP2000/04/04New or Modified Indication
020563011AP2000/04/04Efficacy Supplement with Clinical Data to Support
020563010AP2000/04/04New Dosage Regimen
020563009AP1998/09/04Package Change
020563006AP1998/08/06Package Change
020563005AP1997/04/29Manufacturing Change or Addition
020563004AP1998/02/20Package Change
020563003AP1997/07/16Labeling Revision
020563002AP1997/03/05Manufacturing Change or Addition
020563001AP1997/01/09Labeling Revision
020563000AP1996/06/14Approval