药品名称SAIZEN
申请号019764产品号001
活性成分SOMATROPIN RECOMBINANT市场状态停止上市
剂型或给药途径INJECTABLE;INJECTION规格6MG/VIAL
治疗等效代码参比药物
批准日期1996/10/08申请机构EMD SERONO 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
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
I-4402007/08/26
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
019764072APLabel2014/06/17下载
019764072APLetter2014/06/18下载
019764049APLetter2012/04/05下载
019764049APLabel2012/04/06下载
019764039APLabel2007/08/30下载
019764039APLetter2007/08/30下载
019764037APLabel2007/08/23下载
019764037APLetter2007/08/27下载
019764035APLabel2007/11/07下载
019764035APLetter2007/11/08下载
019764034APLabel2007/03/07下载
019764034APLetter2007/03/15下载
019764030APLabel2007/01/18下载
019764030APLetter2007/01/25下载
019764025APLetter2004/07/14下载
019764025APLabel2004/07/14下载
019764023APLabel2003/07/08下载
019764023APLetter2003/07/08下载
019764020APLetter2004/11/15下载
019764020APLabel2004/11/15下载
019764011APReview2009/01/12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
019764082AP2016/09/07Manufacturing Change or Addition
019764080AP2016/04/21Manufacturing Change or Addition
019764078AP2015/06/12Manufacturing Change or Addition
019764077AP2015/03/03Manufacturing Change or Addition
019764076AP2015/02/16Manufacturing Change or Addition
019764074AP2014/08/11Manufacturing Change or Addition
019764073AP2014/09/30Manufacturing Change or Addition
019764072AP2014/06/16Labeling Revision
019764071AP2013/11/18Manufacturing Change or Addition
019764070AP2013/12/12Manufacturing Change or Addition
019764069AP2013/04/05Manufacturing Change or Addition
019764067AP2013/02/20Manufacturing Change or Addition
019764066AP2013/02/15Manufacturing Change or Addition
019764065AP2013/02/15Manufacturing Change or Addition
019764064AP2013/01/31Manufacturing Change or Addition
019764063AP2013/02/13Manufacturing Change or Addition
019764062AP2015/06/11Manufacturing Change or Addition
019764061AP2013/02/08Manufacturing Change or Addition
019764060AP2013/02/07Manufacturing Change or Addition
019764059AP2013/11/13Manufacturing Change or Addition
019764058AP2013/01/19Manufacturing Change or Addition
019764057AP2013/01/19Manufacturing Change or Addition
019764056AP2013/01/19Manufacturing Change or Addition
019764054AP2013/01/18Manufacturing Change or Addition
019764053AP2013/01/11Manufacturing Change or Addition
019764052AP2013/01/11Manufacturing Change or Addition
019764049AP2012/04/03Labeling Revision
019764039AP2007/08/27Labeling Revision
019764037AP2007/08/22Labeling Revision
019764035AP2007/10/31Package Change
019764034AP2007/03/05Labeling Revision
019764030AP2007/01/16Control Supplement
019764025AP2004/07/09Package Change
019764023AP2003/07/01Labeling Revision
019764020AP2004/11/01New or Modified Indication
019764019AP2002/10/17Control Supplement
019764018AP2002/12/31Manufacturing Change or Addition
019764017AP2002/12/20Manufacturing Change or Addition
019764016AP2001/12/03Control Supplement
019764015AP2002/09/06Control Supplement
019764014AP2001/07/19Manufacturing Change or Addition
019764013AP2001/05/03Manufacturing Change or Addition
019764012AP2000/08/17Control Supplement
019764011AP2000/07/19Control Supplement
019764010AP2000/04/11Manufacturing Change or Addition
019764009AP2000/07/26Labeling Revision
019764008AP2000/06/07Manufacturing Change or Addition
019764007AP2000/03/28Manufacturing Change or Addition
019764006AP2000/04/04Labeling Revision
019764005AP1999/02/11Manufacturing Change or Addition
019764004AP1998/07/09Manufacturing Change or Addition
019764003AP2000/08/29Control Supplement
019764002AP1998/01/21Manufacturing Change or Addition
019764001AP1996/12/09Labeling Revision
019764000AP1996/10/08Approval