药品名称LUPRON
申请号019943产品号002
活性成分LEUPROLIDE ACETATE市场状态处方药
剂型或给药途径INJECTABLE; INJECTION规格3.75MG
治疗等效代码参比药物
批准日期申请机构ABBOTT LABS
化学类型New formulation or new manufacturer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
019943034APLetter2013/10/31下载
019943034APLabel2013/11/05下载
019943033APLabel2012/01/23下载
019943033APLetter2012/01/25下载
019943032APLabel2011/06/16下载
019943032APLetter2011/06/16下载
019943031APLabel2012/03/28下载
019943031APLetter2012/04/02下载
019943030APLabel2010/10/29下载
019943030APLetter2010/11/02下载
019943029APLabel2009/06/04下载
019943029APLetter2009/06/08下载
019943026APLetter2007/11/08下载
019943024APLetter2005/10/20下载
019943024APReview2007/07/09下载
019943022APReview2007/07/09下载
019943022APLetter2005/10/20下载
019943021APLetter2004/01/14下载
019943018APLetter2004/01/22下载
019943010APReview2007/07/09下载
019943003APReview2007/07/09下载
019943000APReview2007/07/09下载
019943000APOther 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
019943034AP2013/10/30Labeling Revision
019943033AP2012/01/23Labeling Revision
019943032AP2011/06/14Labeling Revision
019943031AP2012/03/28Labeling Revision
019943030AP2010/10/29Labeling Revision
019943029AP2009/06/02Labeling Revision
019943026AP2007/10/31Labeling Revision
019943024AP2005/09/15Labeling Revision
019943022AP2005/09/15Control Supplement
019943021AP2004/01/12Labeling Revision
019943019AP2002/09/20Control Supplement
019943018AP2004/01/15Labeling Revision
019943017AP2002/05/23Control Supplement
019943016AP2002/02/21Control Supplement
019943015AP2001/11/14Labeling Revision
019943014AP2001/03/01Labeling Revision
019943013AP2001/01/24Control Supplement
019943012AP2000/05/12Control Supplement
019943011AP2000/05/11Control Supplement
019943010AP1999/08/13Manufacturing Change or Addition
019943009AP1998/06/30Control Supplement
019943007AP1997/06/27Control Supplement
019943006AP1996/09/12Labeling Revision
019943004AP1995/08/11Control Supplement
019943003AP1995/10/26Package Change
019943002AP1995/12/12Labeling Revision
019943001AP1995/09/22Manufacturing Change or Addition
019943000AP1995/03/30Approval