药品名称SEROSTIM
申请号020604产品号002
活性成分SOMATROPIN RECOMBINANT市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格5MG/VIAL
治疗等效代码BX参比药物
批准日期1996/08/23申请机构EMD SERONO INC
化学类型New formulation or new manufacturer审评分类Priority 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
58980302016/04/27YPDF格式
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
M-652010/07/13
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
020604078APLetter2014/06/19下载
020604078APLabel2014/06/23下载
020604049APLetter2012/04/05下载
020604049APLabel2012/04/06下载
020604048APLetter2009/11/19下载
020604044APLabel2007/08/30下载
020604044APLetter2007/08/30下载
020604044APLabel2007/09/04下载
020604044APLetter2007/09/04下载
020604040APReview2011/02/15下载
020604040APLabel2007/07/16下载
020604040APLetter2007/07/24下载
020604035APLabel2006/12/04下载
020604035APLetter2006/12/04下载
020604034APLetter2006/09/25下载
020604034APLabel2006/09/25下载
020604031APLetter2005/08/31下载
020604031APLabel2005/08/31下载
020604030APLetter2004/07/14下载
020604030APLabel2004/07/14下载
020604029APLetter2005/02/17下载
020604029APLabel2005/02/17下载
020604027APLabel2003/09/09下载
020604027APLetter2003/09/09下载
020604027APReview2009/09/16下载
020604026APLetter2003/12/04下载
020604026APLabel2003/12/08下载
020604026APReview2007/08/06下载
020604012APReview2009/09/16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
020604082AP2014/08/11Manufacturing Change or Addition
020604081AP2014/09/30Manufacturing Change or Addition
020604080AP2014/09/17Manufacturing Change or Addition
020604078AP2014/06/16Labeling Revision
020604076AP2013/12/12Manufacturing Change or Addition
020604075AP2013/12/11Manufacturing Change or Addition
020604073AP2013/04/05Manufacturing Change or Addition
020604071AP2013/02/28Manufacturing Change or Addition
020604071AP2013/12/17Manufacturing Change or Addition
020604068AP2013/02/15Manufacturing Change or Addition
020604067AP2013/01/31Manufacturing Change or Addition
020604065AP2013/02/08Manufacturing Change or Addition
020604058AP2012/11/20Manufacturing Change or Addition
020604049AP2012/04/03Labeling Revision
020604048AP2009/08/31Labeling Revision
020604044AP2007/08/27Labeling Revision
020604044AP2007/08/30Labeling Revision
020604040AP2007/07/13Labeling Revision
020604035AP2006/11/27Control Supplement
020604034AP2006/09/21Control Supplement
020604031AP2005/08/24Labeling Revision
020604030AP2004/07/09Package Change
020604029AP2005/02/11Formulation Revision
020604027AP2003/08/29Accelerated Approval
020604026AP2003/12/01Labeling Revision
020604023AP2002/10/17Control Supplement
020604022AP2002/12/31Manufacturing Change or Addition
020604021AP2002/12/20Manufacturing Change or Addition
020604020AP2001/12/03Control Supplement
020604019AP2001/11/19Control Supplement
020604018AP2002/09/06Control Supplement
020604017AP2001/07/19Manufacturing Change or Addition
020604016AP2001/09/06Labeling Revision
020604015AP2001/05/03Manufacturing Change or Addition
020604014AP2001/06/13Labeling Revision
020604013AP2000/08/17Control Supplement
020604012AP2000/07/19Control Supplement
020604011AP2000/04/11Manufacturing Change or Addition
020604010AP2000/10/27Labeling Revision
020604009AP2000/07/17Labeling Revision
020604008AP2000/09/18Expiration Date Change
020604007AP2000/03/28Manufacturing Change or Addition
020604006AP2000/04/04Labeling Revision
020604005AP1998/07/09Control Supplement
020604004AP1998/07/09Manufacturing Change or Addition
020604003AP1998/01/21Manufacturing Change or Addition
020604002AP1997/07/25Control Supplement
020604001AP1998/01/16Labeling Revision
020604000AP1996/08/23Approval