药品名称HUMATROPE
申请号019640产品号004
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1987/03/08申请机构ELI LILLY AND CO
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
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-3982006/07/25
I-5182009/11/01
M-452008/10/12
ODE2013/11/01
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
019640092APLetter2014/07/31下载
019640092APLabel2014/07/31下载
019640086APLabel2011/08/22下载
019640086APLetter2011/08/26下载
019640084APLetter2011/02/28下载
019640084APLabel2011/03/04下载
019640078APLetter2010/07/30下载
019640078APLabel2010/07/31下载
019640070APLetter2009/01/14下载
019640068APLetter2009/03/17下载
019640068APLabel2009/03/17下载
019640058APLabel2006/11/06下载
019640058APLetter2006/11/06下载
019640052APLetter2006/10/27下载
019640052APLabel2006/10/27下载
019640047APLabel2006/10/27下载
019640047APLetter2006/10/27下载
019640046APLetter2006/07/03下载
019640045APLetter2005/10/25下载
019640045APLabel2005/10/25下载
019640040APLetter2004/09/29下载
019640040APLabel2004/09/29下载
019640033APLabel2003/08/14下载
019640033APLetter2004/06/07下载
019640033APReview2007/04/09下载
019640032APReview2007/07/06下载
019640032APLetter2003/03/26下载
019640031APLetter2002/12/04下载
019640025APLetter2002/06/10下载
019640022APReview2009/01/12下载
019640020APReview2008/08/11下载
019640019APReview1997/03/11下载
019640018APReview1997/03/11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
019640098AP2014/11/10Manufacturing Change or Addition
019640097AP2014/09/12Manufacturing Change or Addition
019640096AP2014/08/11Manufacturing Change or Addition
019640095AP2014/04/11Manufacturing Change or Addition
019640093AP2014/01/24Manufacturing Change or Addition
019640092AP2014/07/30Labeling Revision
019640090AP2013/05/24Manufacturing Change or Addition
019640086AP2011/08/22Labeling Revision
019640084AP2011/02/23Labeling Revision
019640078AP2010/07/28Labeling Revision
019640070AP2009/01/12Control Supplement
019640068AP2009/03/12New or Modified Indication
019640058AP2006/11/01New or Modified Indication
019640052AP2006/10/26Control Supplement
019640047AP2006/10/26Labeling Revision
019640046AP2006/06/28Package Change
019640045AP2005/10/12Supplement
019640040AP2004/09/22Labeling Revision
019640033AP2003/07/25New or Modified Indication
019640032AP2003/03/24Labeling Revision
019640031AP2002/12/04Labeling Revision
019640030AP2001/05/22Manufacturing Change or Addition
019640029AP2001/05/01Control Supplement
019640028AP2001/01/17Control Supplement
019640026AP2001/02/12Labeling Revision
019640025AP2002/06/10Labeling Revision
019640024AP1999/09/07Manufacturing Change or Addition
019640022AP1999/02/04Formulation Revision
019640021AP1997/10/03Labeling Revision
019640020AP1997/06/13Control Supplement
019640019AP1997/03/11Labeling Revision
019640018AP1997/03/11New or Modified Indication
019640017AP1996/08/05Labeling Revision
019640016AP1996/11/22Control Supplement
019640015AP1996/11/07Labeling Revision
019640014AP1995/12/15Manufacturing Change or Addition
019640013AP1996/08/01New or Modified Indication
019640012AP1995/09/22Labeling Revision
019640011AP1995/09/13Control Supplement
019640010AP1995/01/11Control Supplement
019640009AP1994/04/15New Dosage Regimen
019640008AP1993/11/18Labeling Revision
019640007AP1993/12/14Control Supplement
019640006AP1992/03/18Labeling Revision
019640005AP1990/10/11Labeling Revision
019640004AP1990/04/23Control Supplement
019640003AP1989/04/04Labeling Revision
019640002AP1989/05/10New Route of Administration
019640001AP1987/06/23Formulation Revision
019640000AP1987/03/08Approval