药品名称NOVANTRONE
申请号019297产品号002
活性成分MITOXANTRONE HYDROCHLORIDE市场状态停止上市
剂型或给药途径INJECTABLE;INJECTION规格EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)
治疗等效代码参比药物
批准日期1987/12/23申请机构EMD SERONO INC
化学类型New molecular entity (NME)审评分类Standard 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
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
ODE2007/10/13
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
019297035APLetter2012/03/26下载
019297035APLabel2012/03/27下载
019297035APMedication Guide2012/03/27下载
019297034APLabel2010/06/24下载
019297034APLetter2010/06/16下载
019297033APLabel2010/06/24下载
019297033APLetter2010/06/16下载
019297031APLetter2009/02/13下载
019297031APLabel2009/02/12下载
019297030APLetter2009/02/13下载
019297030APLabel2009/02/12下载
019297029APLetter2007/04/20下载
019297028APLetter2005/04/28下载
019297028APLabel2005/04/28下载
019297027APLetter2003/01/13下载
019297026APLetter2003/01/13下载
019297025APLetter2003/01/13下载
019297024APLetter2002/02/20下载
019297021APReview2000/02/04下载
019297014APReview1997/11/20下载
019297000APReview2008/04/04下载
019297000APOther Important Information from FDA2008/07/29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
019297035AP2012/03/23Labeling Revision
019297034AP2010/06/13Labeling Revision
019297033AP2010/06/13Labeling Revision
019297031AP2009/02/11Labeling Revision
019297030AP2009/02/11Labeling Revision
019297029AP2007/04/11Manufacturing Change or Addition
019297028AP2005/04/27Labeling Revision
019297027AP2003/01/13Labeling Revision
019297026AP2003/01/13Labeling Revision
019297025AP2003/01/13Labeling Revision
019297024AP2002/02/20Labeling Revision
019297023AP2001/02/09Control Supplement
019297022AP2001/01/31Labeling Revision
019297021AP2000/02/04Labeling Revision
019297020AP2000/10/19Control Supplement
019297019AP1998/05/08Labeling Revision
019297018AP1997/09/19Labeling Revision
019297017AP1998/08/13Manufacturing Change or Addition
019297016AP1997/05/23Labeling Revision
019297015AP1997/05/08Control Supplement
019297014AP1996/11/13New or Modified Indication
019297012AP1996/10/18Labeling Revision
019297011AP1995/04/10Control Supplement
019297010AP1994/09/23Labeling Revision
019297009AP1994/04/15Control Supplement
019297008AP1990/07/30Control Supplement
019297006AP1992/02/19Manufacturing Change or Addition
019297005AP1990/02/22Package Change
019297002AP1990/11/26Control Supplement
019297001AP1988/03/17Manufacturing Change or Addition
019297000AP1987/12/23Approval