药品名称LOVENOX
申请号020164产品号009
活性成分ENOXAPARIN SODIUM市场状态处方药
剂型或给药途径INJECTABLE;INTRAVENOUS, SUBCUTANEOUS规格300MG/3ML (100MG/ML)
治疗等效代码AB参比药物
批准日期2003/01/23申请机构SANOFI AVENTIS US LLC
化学类型New molecular entity (NME)审评分类Priority 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
53896182012/02/14YYU-545PDF格式
RE387432012/02/14YYU-545PDF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
I-5332010/05/16
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
020164102APLetter2013/10/25下载
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020164000APOther Important Information from FDA2013/11/07下载
020164000APReview2004/07/15下载
020164000APLetter2004/02/25下载
020164000APLabel2004/04/05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
020164107AP2015/08/24Manufacturing Change or Addition
020164106AP2015/08/03Manufacturing Change or Addition
020164105AP2014/05/29Manufacturing Change or Addition
020164103AP2013/09/27Manufacturing Change or Addition
020164102AP2013/10/23Labeling Revision
020164100AP2013/06/05Labeling Revision
020164099AP2012/11/28Manufacturing Change or Addition
020164098AP2013/09/06Manufacturing Change or Addition
020164093AP2011/04/20Labeling Revision
020164092AP2011/04/13Labeling Revision
020164089AP2012/12/06Manufacturing Change or Addition
020164085AP2009/12/23Labeling Revision
020164083AP2009/07/23Labeling Revision
020164080AP2008/07/16Labeling Revision
020164079AP2012/12/10Manufacturing Change or Addition
020164075AP2007/05/16Labeling Revision
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020164056AP2004/04/13Labeling Revision
020164055AP2004/07/23Control Supplement
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020164038AP2000/06/20Manufacturing Change or Addition
020164037AP2000/11/17Labeling Revision
020164036AP2000/11/17New or Modified Indication
020164035AP2000/04/04Package Change
020164034AP2000/05/30Efficacy Supplement with Clinical Data to Support
020164032AP2000/01/27Manufacturing Change or Addition
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020164013AP1997/05/16Manufacturing Change or Addition
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020164000AP1993/03/29Approval