药品名称NUTROPIN AQ
申请号020522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10MG/2ML (5MG/ML)
治疗等效代码参比药物
批准日期1995/12/29申请机构GENENTECH 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
57633942015/06/09YPDF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
I-4622008/06/28
M-502008/11/18
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
020522051APLabel2014/06/17下载
020522051APLetter2014/06/18下载
020522045APLetter2012/04/12下载
020522045APLabel2012/04/17下载
020522037APLetter2008/01/09下载
020522037APLabel2008/01/08下载
020522036APLabel2008/01/08下载
020522036APLetter2008/01/09下载
020522033APLabel2007/02/21下载
020522033APLetter2007/02/23下载
020522027APLabel2005/11/22下载
020522027APLetter2005/11/22下载
020522026APLetter2008/01/09下载
020522026APLabel2008/01/08下载
020522022APOther2005/07/26下载
020522022APLetter2005/06/29下载
020522022APLabel2005/06/29下载
020522022APOther2005/07/22下载
020522021APOther2005/07/26下载
020522021APOther2005/07/22下载
020522021APLabel2005/06/29下载
020522021APLetter2005/06/29下载
020522017APLetter2002/04/22下载
020522017APLabel2002/04/22下载
020522013APLetter2000/04/13下载
020522013APReview2003/07/08下载
020522013APLabel2004/06/10下载
020522011APReview2007/08/06下载
020522009APLetter1999/12/01下载
020522009APReview2003/05/15下载
020522004APReview1997/12/17下载
020522002APReview1997/03/24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
020522059AP2016/05/18Manufacturing Change or Addition
020522058AP2016/03/17Manufacturing Change or Addition
020522057AP2016/02/26Manufacturing Change or Addition
020522056AP2016/01/13Manufacturing Change or Addition
020522055AP2015/06/23Manufacturing Change or Addition
020522054AP2015/05/26Manufacturing Change or Addition
020522052AP2014/05/15Manufacturing Change or Addition
020522051AP2014/06/16Labeling Revision
020522050AP2013/09/17Manufacturing Change or Addition
020522049AP2013/07/18Manufacturing Change or Addition
020522045AP2012/04/10Labeling Revision
020522037AP2008/01/03Control Supplement
020522036AP2008/01/03Control Supplement
020522033AP2007/02/15Labeling Revision
020522027AP2005/11/18Efficacy Supplement with Clinical Data to Support
020522026AP2008/01/03Manufacturing Change or Addition
020522022AP2005/06/28Labeling Revision
020522021AP2005/06/28New or Modified Indication
020522017AP2002/04/22Package Change
020522016AP2001/09/17Manufacturing Change or Addition
020522015AP2001/05/02Manufacturing Change or Addition
020522014AP2001/09/17Control Supplement
020522013AP2000/04/13New Dosage Regimen
020522012AP1999/10/13Control Supplement
020522011AP1999/11/24Labeling Revision
020522010AP1999/11/03Manufacturing Change or Addition
020522009AP1999/12/01Efficacy Supplement with Clinical Data to Support
020522008AP1998/09/25Control Supplement
020522007AP1998/09/25Control Supplement
020522006AP1998/10/26Manufacturing Change or Addition
020522005AP1998/07/09Control Supplement
020522004AP1997/12/17New or Modified Indication
020522003AP1997/09/12Control Supplement
020522002AP1997/03/24New or Modified Indication
020522001AP1996/08/07Control Supplement
020522000AP1995/12/29Approval