药品名称MAXIPIME
申请号050679产品号003
活性成分CEFEPIME HYDROCHLORIDE市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格EQ 2GM BASE/VIAL
治疗等效代码AP参比药物
批准日期1996/01/18申请机构HOSPIRA INC
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
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
050679040APLetter2016/03/03下载
050679040APLabel2016/03/03下载
050679036APLetter2012/09/10下载
050679036APLabel2012/09/11下载
050679034APLetter2013/03/18下载
050679034APLabel2013/03/19下载
050679032APLabel2009/09/30下载
050679032APLetter2009/11/20下载
050679031APLabel2014/05/02下载
050679031APLetter2014/05/06下载
050679028APLabel2007/09/19下载
050679024APLetter2007/11/26下载
050679023APLetter2004/06/10下载
050679023APLabel2004/06/10下载
050679021APLabel2003/03/26下载
050679021APLetter2003/03/26下载
050679018APLetter2002/08/21下载
050679014APLetter2002/08/21下载
050679009APLetter2002/08/21下载
050679007APReview2001/07/18下载
050679007APLetter1999/01/27下载
050679007APLabel1999/01/27下载
050679002APReview1997/05/16下载
050679000APOther Important Information from FDA2007/12/17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
050679041AP2016/06/22Manufacturing Change or Addition
050679040AP2016/03/01Labeling Revision
050679039AP2016/03/04Manufacturing Change or Addition
050679038AP2014/06/12Manufacturing Change or Addition
050679036AP2012/09/06Labeling Revision
050679034AP2013/03/15Labeling Revision
050679032AP2009/09/30Labeling Revision
050679031AP2014/05/01Labeling Revision
050679028AP2007/09/14Labeling Revision
050679024AP2007/09/14Labeling Revision
050679023AP2004/06/09Supplement
050679021AP2003/03/17New Dosage Regimen
050679020AP2002/03/15Control Supplement
050679019AP2001/06/20Package Change
050679018AP2002/08/21Labeling Revision
050679017AP2001/04/02Package Change
050679016AP2000/05/10Manufacturing Change or Addition
050679015AP2000/06/26Labeling Revision
050679014AP2002/08/21Labeling Revision
050679013AP2000/09/20Labeling Revision
050679012AP1998/11/24Manufacturing Change or Addition
050679011AP1998/07/21Control Supplement
050679010AP1998/01/30Package Change
050679009AP2002/08/21Labeling Revision
050679008AP1998/01/30New or Modified Indication
050679007AP1999/01/27Labeling Revision
050679005AP1999/02/08Labeling Revision
050679004AP1997/10/20Manufacturing Change or Addition
050679003AP1996/12/23Control Supplement
050679002AP1997/05/16New or Modified Indication
050679001AP1996/03/13Control Supplement
050679000AP1996/01/18Approval