药品名称BLENOXANE
申请号050443产品号001
活性成分BLEOMYCIN SULFATE市场状态停止上市
剂型或给药途径INJECTABLE;INJECTION规格EQ 15 UNITS BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
化学类型New molecular entity (NME)审评分类
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
050443036APLabel2010/05/11下载
050443036APLetter2010/05/17下载
050443035APLabel2003/03/26下载
050443035APLetter2003/03/26下载
050443027APLetter2004/07/01下载
050443026APReview1999/08/02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
050443036AP2010/05/10Labeling Revision
050443035AP2003/03/21Labeling Revision
050443033AP2002/03/20Manufacturing Change or Addition
050443032AP2000/07/03Manufacturing Change or Addition
050443031AP2000/04/12Package Change
050443030AP2000/07/03Manufacturing Change or Addition
050443029AP1999/10/20Labeling Revision
050443028AP1999/08/25Labeling Revision
050443027AP2004/06/30Labeling Revision
050443026AP1996/09/30Manufacturing Change or Addition
050443025AP1996/02/20New or Modified Indication
050443024AP1995/09/07Manufacturing Change or Addition
050443023AP1993/02/23Labeling Revision
050443022AP1994/01/21Control Supplement
050443021AP1994/01/21Manufacturing Change or Addition
050443020AP1991/01/30Control Supplement
050443019AP1994/01/21Control Supplement
050443017AP1994/01/21Control Supplement
050443014AP1983/10/21Control Supplement
050443013AP1983/10/19Expiration Date Change
050443012AP1983/09/26Control Supplement
050443011AP1983/04/13Labeling Revision
050443010AP1982/12/13Control Supplement
050443009AP1976/12/21Labeling Revision
050443008AP1976/03/15Labeling Revision
050443007AP1976/03/31Control Supplement
050443006AP1975/10/10Control Supplement
050443005AP1976/04/05Expiration Date Change
050443004AP1975/10/08Labeling Revision
050443003AP1975/03/05Control Supplement
050443002AP1974/08/09Labeling Revision
050443000AP1973/07/31Approval