药品名称AMBISOME
申请号050740产品号001
活性成分AMPHOTERICIN B市场状态处方药
剂型或给药途径INJECTABLE, LIPOSOMAL;INJECTION规格50MG/VIAL
治疗等效代码参比药物
批准日期1997/08/11申请机构ASTELLAS PHARMA US INC
化学类型New active ingredient审评分类Priority review drug
罕用药/孤儿药
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
58741042016/02/23YU-922PDF格式
59651562016/10/12YU-922PDF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
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
050740021APLabel2012/03/09下载
050740021APLetter2012/03/13下载
050740016APLetter2008/10/14下载
050740016APLabel2008/11/07下载
050740014APLetter2003/09/25下载
050740014APLabel2003/09/26下载
050740002APReview2004/05/27下载
050740002APLetter2000/07/18下载
050740002APLabel2000/07/18下载
050740001APReview2003/07/31下载
050740001APLetter2000/01/28下载
050740001APLabel2000/01/28下载
050740000APReview2009/06/19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
050740025AP2016/09/23Manufacturing Change or Addition
050740023AP2014/09/16Manufacturing Change or Addition
050740021AP2012/03/08Labeling Revision
050740016AP2008/10/08Labeling Revision
050740014AP2003/09/16Labeling Revision
050740012AP2002/09/06Control Supplement
050740011AP2002/06/14Manufacturing Change or Addition
050740010AP2002/03/27Control Supplement
050740009AP2002/03/06Manufacturing Change or Addition
050740008AP2001/12/04Control Supplement
050740007AP2001/05/11Control Supplement
050740006AP2000/07/13Package Change
050740005AP2000/06/26Manufacturing Change or Addition
050740004AP2000/02/29Manufacturing Change or Addition
050740003AP2000/03/16Manufacturing Change or Addition
050740002AP2000/06/16New or Modified Indication
050740001AP2000/01/28Efficacy Supplement with Clinical Data to Support
050740000AP1997/08/11Approval