药品名称LUPRON DEPOT-PED
申请号020263产品号003
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,7.5MG/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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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1993/04/16申请机构ABBVIE ENDOCRINE INC
化学类型New formulation or new manufacturer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
48492282006/07/18PDF格式
55759872013/09/02PDF格式
56310202014/05/20PDF格式
57166402013/09/02PDF格式
60369762013/12/13PDF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
020263039APLetter2013/05/16下载
020263039APLabel2013/05/21下载
020263037APLetter2011/10/12下载
020263037APLabel2011/10/12下载
020263036APLabel2011/08/15下载
020263036APLetter2011/08/17下载
020263035APLabel2010/08/30下载
020263035APLetter2010/09/02下载
020263033APLabel2009/06/29下载
020263033APLetter2009/06/30下载
020263030APLetter2008/08/05下载
020263028APLabel2006/02/22下载
020263028APLetter2006/02/22下载
020263028APReview2007/07/09下载
020263026APLabel2005/11/17下载
020263026APLetter2005/11/18下载
020263024APLetter2004/03/10下载
020263024APLabel2004/04/05下载
020263023APLetter2003/12/24下载
020263022APLetter2003/10/31下载
020263020APLetter2002/09/24下载
020263012APReview2007/07/09下载
020263006APReview2007/07/09下载
020263003APReview2007/07/09下载
020263000APOther 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
020263039AP2013/05/14Labeling Revision
020263037AP2011/10/08Efficacy Supplement with Clinical Data to Support
020263036AP2011/08/15Efficacy Supplement with Clinical Data to Support
020263035AP2010/08/30Labeling Revision
020263033AP2009/06/24Labeling Revision
020263030AP2008/07/31Labeling Revision
020263028AP2006/02/16Labeling Revision
020263026AP2005/11/09Control Supplement
020263024AP2004/03/02Labeling Revision
020263023AP2003/12/23Labeling Revision
020263022AP2003/10/28Labeling Revision
020263020AP2002/09/24Control Supplement
020263019AP2002/05/16Control Supplement
020263018AP2002/03/08Control Supplement
020263017AP2001/08/06Labeling Revision
020263015AP2001/01/26Control Supplement
020263014AP2000/05/12Control Supplement
020263013AP2000/05/11Control Supplement
020263012AP1999/08/13Manufacturing Change or Addition
020263011AP1998/06/30Control Supplement
020263010AP1997/06/27Control Supplement
020263009AP1997/01/10Labeling Revision
020263008AP1995/08/11Control Supplement
020263007AP1995/09/22Manufacturing Change or Addition
020263006AP1995/10/26Package Change
020263005AP1995/03/24Labeling Revision
020263004AP1994/11/07Control Supplement
020263003AP1994/02/14Expiration Date Change
020263001AP1994/01/21Control Supplement
020263000AP1993/04/16Approval