药品名称LUPRON DEPOT
申请号020011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剂型或给药途径INJECTABLE;INJECTION规格3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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1990/10/22申请机构ABBVIE ENDOCRINE INC
化学类型New dosage form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
48492282006/07/18PDF格式
55759872013/09/02PDF格式
56310212014/05/20PDF格式
57166402013/09/02PDF格式
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
020011041APLetter2013/10/31下载
020011041APLabel2013/11/05下载
020011040APLabel2012/01/23下载
020011040APLetter2012/01/25下载
020011039APLabel2011/06/16下载
020011039APLetter2011/06/16下载
020011038APLabel2012/03/28下载
020011038APLetter2012/04/02下载
020011037APLabel2010/10/29下载
020011037APLetter2010/11/02下载
020011036APLabel2009/06/04下载
020011036APLetter2009/06/08下载
020011033APLetter2007/11/08下载
020011031APLetter2005/10/20下载
020011029APLetter2005/10/20下载
020011028APLetter2004/01/14下载
020011025APLetter2004/01/22下载
020011021APLetter2001/09/21下载
020011021APLabel2001/09/21下载
020011021APReview2001/11/14下载
020011014APLetter1998/04/09下载
020011014APReview2001/08/06下载
020011000APOther 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
020011041AP2013/10/30Labeling Revision
020011040AP2012/01/23Labeling Revision
020011039AP2011/06/14Labeling Revision
020011038AP2012/03/28Labeling Revision
020011037AP2010/10/29Labeling Revision
020011036AP2009/06/02Labeling Revision
020011033AP2007/10/31Labeling Revision
020011031AP2005/09/15Labeling Revision
020011029AP2005/09/15Control Supplement
020011028AP2004/01/12Labeling Revision
020011026AP2002/09/20Control Supplement
020011025AP2004/01/15Labeling Revision
020011024AP2002/05/23Control Supplement
020011023AP2002/02/21Control Supplement
020011022AP2001/11/14Labeling Revision
020011021AP2001/09/21New or Modified Indication
020011020AP2001/03/01Labeling Revision
020011019AP2001/01/24Control Supplement
020011018AP2000/05/12Control Supplement
020011017AP2000/05/11Control Supplement
020011016AP1999/08/13Manufacturing Change or Addition
020011015AP1998/06/30Control Supplement
020011014AP1998/04/09New or Modified Indication
020011011AP1997/06/27Control Supplement
020011010AP1996/09/12Labeling Revision
020011008AP1995/08/11Control Supplement
020011007AP1995/09/22Manufacturing Change or Addition
020011006AP1995/10/26Package Change
020011005AP1994/07/21Labeling Revision
020011004AP1994/11/07Control Supplement
020011003AP1994/02/14Expiration Date Change
020011002AP1994/04/26Labeling Revision
020011000AP1990/10/22Approval