药品名称LUPRON
申请号019010产品号001
活性成分LEUPROLIDE ACETATE市场状态停止上市
剂型或给药途径INJECTABLE;INJECTION规格1MG/0.2ML
治疗等效代码参比药物
批准日期1985/04/09申请机构ABBVIE ENDOCRINE INC
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
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
019010037APLabel2014/07/11下载
019010037APLetter2014/07/11下载
019010036APLetter2011/01/20下载
019010036APLabel2011/01/20下载
019010035APLabel2011/03/21下载
019010035APLetter2011/03/24下载
019010033APLetter2010/05/04下载
019010033APLabel2010/05/07下载
019010032APLetter2007/09/25下载
019010031APLetter2005/10/20下载
019010031APReview2007/07/09下载
019010028APLetter2004/10/22下载
019010027APLetter2003/12/02下载
019010024APReview2007/07/09下载
019010023APReview2007/07/09下载
019010006APReview2007/07/09下载
019010000APOther Important Information from FDA2011/12/20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
019010037AP2014/07/10Labeling Revision
019010036AP2011/01/14Labeling Revision
019010035AP2011/03/21Labeling Revision
019010033AP2010/04/28Labeling Revision
019010032AP2007/09/14Labeling Revision
019010031AP2005/09/15Labeling Revision
019010028AP2004/10/18Labeling Revision
019010027AP2003/11/25Labeling Revision
019010024AP2002/05/16Manufacturing Change or Addition
019010023AP2002/05/16Manufacturing Change or Addition
019010022AP2000/12/21Control Supplement
019010021AP1999/11/22Control Supplement
019010020AP1998/09/25Control Supplement
019010019AP1998/01/08Control Supplement
019010018AP1997/07/07Control Supplement
019010017AP1997/07/07Control Supplement
019010015AP1996/05/28Control Supplement
019010014AP1996/04/24Control Supplement
019010012AP1994/05/09Control Supplement
019010011AP1994/05/09Manufacturing Change or Addition
019010010AP1993/06/09Control Supplement
019010009AP1992/07/07Control Supplement
019010008AP1991/10/21Control Supplement
019010006AP1988/05/09Formulation Revision
019010005AP1987/01/14Control Supplement
019010004AP1987/03/12Labeling Revision
019010003AP1988/01/19Control Supplement
019010002AP1986/07/10Control Supplement
019010000AP1985/04/09Approval