药品名称LOVENOX (PRESERVATIVE FREE)
申请号020164产品号002
活性成分ENOXAPARIN SODIUM市场状态处方药
剂型或给药途径INJECTABLE;SUBCUTANEOUS规格40MG/0.4ML (100MG/ML)
治疗等效代码AP参比药物
批准日期1998/01/30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
020164102APLabel2013/10/31下载
020164100APLetter2013/06/07下载
020164100APLabel2013/06/11下载
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020164080APLabel2008/07/22下载
020164075APLetter2007/05/29下载
020164075APLabel2007/05/29下载
020164075APReview2009/03/24下载
020164070APLabel2007/01/16下载
020164070APLetter2007/01/16下载
020164063APLetter2005/03/10下载
020164058APLetter2004/04/29下载
020164058APReview2007/07/09下载
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020164057APLetter2004/05/26下载
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020164055APReview2006/10/26下载
020164055APLetter2004/07/28下载
020164055APLabel2004/07/28下载
020164053APLetter2004/10/26下载
020164051APReview2008/08/01下载
020164051APLetter2003/07/06下载
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020164045APLetter2002/01/09下载
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020164043APLetter2003/01/23下载
020164043APReview2008/08/01下载
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020164040APLetter2002/01/09下载
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020164037APLabel2000/11/17下载
020164036APLetter2000/11/17下载
020164036APLabel2000/11/17下载
020164034APLetter2000/09/27下载
020164032APReview2008/08/04下载
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020164020APLetter2000/08/04下载
020164019APReview2008/08/08下载
020164015APReview2000/07/03下载
020164015APLetter1998/12/31下载
020164015APLabel1998/12/31下载
020164013APReview2008/08/11下载
020164012APReview2008/08/11下载
020164011APReview2008/08/08下载
020164010APReview2003/04/29下载
020164010APLetter2004/06/08下载
020164009APReview2008/08/11下载
020164005APReview2008/08/11下载
020164004APReview2008/08/11下载
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
020164070AP2007/01/12Package Change
020164063AP2005/03/07Labeling Revision
020164058AP2004/04/21Labeling Revision
020164057AP2004/05/18Labeling Revision
020164056AP2004/04/13Labeling Revision
020164055AP2004/07/23Control Supplement
020164053AP2004/10/20Manufacturing Change or Addition
020164051AP2003/06/20Labeling Revision
020164050AP2003/07/01Labeling Revision
020164048AP2003/12/18Labeling Revision
020164046AP2002/01/09Labeling Revision
020164045AP2002/01/09Labeling Revision
020164044AP2001/11/30Control Supplement
020164043AP2003/01/23Manufacturing Change or Addition
020164042AP2001/07/05Manufacturing Change or Addition
020164041AP2000/12/14Manufacturing Change or Addition
020164040AP2002/01/09Labeling Revision
020164039AP2000/10/24Control Supplement
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
020164031AP1999/10/05Labeling Revision
020164030AP2000/06/02Formulation Revision
020164028AP1999/09/28Labeling Revision
020164027AP1999/10/05Control Supplement
020164026AP1999/09/14Control Supplement
020164024AP1999/07/22Control Supplement
020164023AP1999/11/08Manufacturing Change or Addition
020164022AP1999/07/21Control Supplement
020164021AP1999/04/20Labeling Revision
020164020AP2000/08/03Efficacy Supplement with Clinical Data to Support
020164019AP1999/03/03Package Change
020164017AP1997/05/27Labeling Revision
020164016AP1998/03/27New or Modified Indication
020164015AP1998/12/31New or Modified Indication
020164014AP1997/01/27Labeling Revision
020164013AP1997/05/16Manufacturing Change or Addition
020164012AP1996/10/23Manufacturing Change or Addition
020164011AP1998/02/24Control Supplement
020164010AP1998/01/30New or Modified Indication
020164009AP1996/06/26Package Change
020164008AP1997/05/06New or Modified Indication
020164007AP1997/03/07Package Change
020164006AP1997/05/27Labeling Revision
020164005AP1996/01/30Labeling Revision
020164004AP1996/03/15Manufacturing Change or Addition
020164002AP1995/03/09New or Modified Indication
020164001AP1994/03/14Labeling Revision
020164000AP1993/03/29Approval