药品名称CUBICIN
申请号021572产品号002
活性成分DAPTOMYCIN市场状态处方药
剂型或给药途径POWDER;INTRAVENOUS规格500MG/VIAL
治疗等效代码AP参比药物
批准日期2003/09/12申请机构CUBIST PHARMACEUTICALS 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
64689672019/09/24U-282PDF格式
68526892019/09/24U-282PDF格式
80036732028/09/04U-1180PDF格式
RE390712016/06/15YYU-728PDF格式
80582382020/11/28YYPDF格式
81293422020/11/28YYPDF格式
历史专利信息
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-5052009/05/25
NCE2008/09/12
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
021572053APLetter2016/07/12下载
021572053APLabel2016/07/18下载
021572052APLabel2016/07/08下载
021572050APLetter2015/09/18下载
021572050APLabel2015/12/03下载
021572048APLabel2015/08/04下载
021572048APLetter2015/08/06下载
021572046APLetter2014/11/28下载
021572046APLabel2014/12/19下载
021572044APLabel2013/11/26下载
021572044APLetter2013/11/26下载
021572043APLabel2013/11/26下载
021572043APLetter2013/11/26下载
021572040APLabel2012/10/12下载
021572040APLetter2012/10/15下载
021572039APLetter2012/06/15下载
021572039APLabel2012/06/18下载
021572038APLabel2011/10/03下载
021572038APLetter2011/10/04下载
021572037APLetter2012/05/23下载
021572037APLabel2012/05/23下载
021572033APLabel2010/08/28下载
021572032APLetter2010/12/06下载
021572032APLabel2010/12/02下载
021572031APLetter2010/12/10下载
021572030APLabel2010/12/02下载
021572030APLetter2010/12/06下载
021572027APLabel2010/12/02下载
021572027APLetter2010/12/06下载
021572024APLetter2010/12/06下载
021572024APLabel2010/12/02下载
021572023APLabel2010/12/02下载
021572023APLetter2010/12/06下载
021572022APLetter2010/12/06下载
021572022APLabel2010/12/02下载
021572021APLetter2009/02/13下载
021572014APLetter2007/10/10下载
021572014APLabel2007/10/10下载
021572011APLabel2007/02/21下载
021572011APLetter2007/02/23下载
021572010APLabel2007/02/21下载
021572010APLetter2007/02/23下载
021572009APLabel2006/10/25下载
021572009APLetter2006/11/06下载
021572008APLabel2006/05/26下载
021572008APLetter2006/05/26下载
021572007APLetter2007/08/22下载
021572007APLabel2007/08/22下载
021572006APLetter2005/10/19下载
021572006APLabel2005/10/19下载
021572000APLetter2003/09/25下载
021572000APLabel2003/09/25下载
021572000APReview2003/12/15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
021572053AP2016/07/06Labeling Revision
021572052AP2016/07/06Labeling Revision
021572050AP2015/09/17Labeling Revision
021572049AP2015/07/15Manufacturing Change or Addition
021572048AP2015/08/03Labeling Revision
021572047AP2015/02/16Manufacturing Change or Addition
021572046AP2014/11/26Labeling Revision
021572045AP2014/09/26Manufacturing Change or Addition
021572044AP2013/11/22Labeling Revision
021572043AP2013/11/22Labeling Revision
021572042AP2013/06/26Manufacturing Change or Addition
021572041AP2013/03/19Manufacturing Change or Addition
021572040AP2012/10/11Labeling Revision
021572039AP2012/06/14Labeling Revision
021572038AP2011/10/03Labeling Revision
021572037AP2012/05/22Labeling Revision
021572034AP2010/12/14Manufacturing Change or Addition
021572033AP2010/08/13Labeling Revision
021572032AP2010/11/30Labeling Revision
021572031AP2010/12/06Labeling Revision
021572030AP2010/11/30Labeling Revision
021572027AP2010/11/30Labeling Revision
021572024AP2010/11/30Labeling Revision
021572023AP2010/11/30New Dosage Regimen
021572022AP2010/11/30Labeling Revision
021572021AP2009/02/10Labeling Revision
021572014AP2007/10/05Labeling Revision
021572011AP2007/02/20Labeling Revision
021572010AP2007/02/12Labeling Revision
021572009AP2006/10/24Labeling Revision
021572008AP2006/05/25New or Modified Indication
021572007AP2006/03/08Labeling Revision
021572006AP2005/10/14Labeling Revision
021572000AP2003/09/12Approval