药品名称GENOTROPIN PRESERVATIVE FREE
申请号020280产品号001
活性成分SOMATROPIN RECOMBINANT市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格0.2MG/VIAL
治疗等效代码参比药物
批准日期1998/01/27申请机构PHARMACIA AND UPJOHN CO
化学类型New formulation or new manufacturer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
61528972018/11/20YPDF格式
历史专利信息
49682992008/06/28YPDF格式
54350762013/04/16YPDF格式
55016732013/04/16YPDF格式
57163382015/02/10YPDF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-4962009/04/27
ODE2007/06/20
ODE2008/07/25
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
020280079APLetter2016/09/07下载
020280079APLabel2016/09/08下载
020280078APLetter2015/06/24下载
020280078APLabel2015/06/24下载
020280077APLetter2014/09/29下载
020280077APLabel2014/09/30下载
020280072APLabel2012/02/06下载
020280072APLetter2012/02/08下载
020280071APLetter2011/05/19下载
020280071APLabel2011/05/23下载
020280068APLabel2010/02/16下载
020280068APLetter2010/02/16下载
020280066APLetter2008/12/19下载
020280066APLabel2009/01/02下载
020280064APLabel2009/05/25下载
020280064APLetter2009/05/26下载
020280061APLabel2009/01/06下载
020280061APLetter2009/01/06下载
020280060APLetter2008/06/13下载
020280060APLabel2008/06/18下载
020280060APSummary Review2008/07/16下载
020280057APLetter2007/03/15下载
020280057APLabel2007/03/15下载
020280055APLetter2007/07/24下载
020280055APLabel2007/07/24下载
020280049APLabel2006/05/01下载
020280049APLetter2006/05/01下载
020280049APReview2006/04/01下载
020280044APLetter2003/11/25下载
020280040APLabel2003/05/29下载
020280040APLetter2003/06/08下载
020280038APLetter2003/04/15下载
020280031APLetter2001/07/25下载
020280031APLabel2001/07/25下载
020280031APReview2001/07/25下载
020280023APLetter2000/06/20下载
020280008APReview2011/02/04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
020280085AP2016/08/15Manufacturing Change or Addition
020280084AP2016/06/16Manufacturing Change or Addition
020280082AP2015/12/28Manufacturing Change or Addition
020280081AP2015/09/10Manufacturing Change or Addition
020280080AP2015/02/16Manufacturing Change or Addition
020280079AP2016/09/06Labeling Revision
020280078AP2015/06/22Labeling Revision
020280077AP2014/09/25Labeling Revision
020280075AP2013/10/17Manufacturing Change or Addition
020280074AP2013/04/19Manufacturing Change or Addition
020280072AP2012/02/06Labeling Revision
020280071AP2011/05/17Labeling Revision
020280068AP2010/02/02Labeling Revision
020280066AP2008/12/15Labeling Revision
020280064AP2009/05/20Manufacturing Change or Addition
020280061AP2009/01/05Control Supplement
020280060AP2008/06/12New or Modified Indication
020280057AP2007/03/14Labeling Revision
020280055AP2007/07/22Control Supplement
020280055AP2007/08/10Control Supplement
020280049AP2006/04/27New or Modified Indication
020280044AP2003/10/31Labeling Revision
020280041AP2002/11/05Control Supplement
020280040AP2003/05/12Control Supplement
020280039AP2002/08/15Manufacturing Change or Addition
020280038AP2003/03/28Manufacturing Change or Addition
020280037AP2002/01/29Control Supplement
020280036AP2001/09/21Manufacturing Change or Addition
020280035AP2001/07/09Manufacturing Change or Addition
020280034AP2001/01/26Control Supplement
020280033AP2000/12/08Manufacturing Change or Addition
020280032AP2000/11/07Manufacturing Change or Addition
020280031AP2001/07/25New or Modified Indication
020280030AP2000/07/21Control Supplement
020280029AP2000/10/05Manufacturing Change or Addition
020280028AP2000/08/18Labeling Revision
020280027AP2000/07/31Control Supplement
020280026AP2000/05/26Control Supplement
020280025AP2000/07/11Labeling Revision
020280024AP2000/05/12Control Supplement
020280023AP2000/06/20New or Modified Indication
020280022AP2000/04/11Manufacturing Change or Addition
020280021AP2000/07/11Manufacturing Change or Addition
020280020AP2000/01/19Control Supplement
020280018AP1999/04/30Control Supplement
020280017AP1999/04/27Control Supplement
020280016AP1999/02/24Manufacturing Change or Addition
020280015AP1998/07/30Control Supplement
020280013AP1999/04/30Control Supplement
020280012AP1998/08/18Control Supplement
020280011AP1998/08/04Control Supplement
020280010AP1998/01/05Control Supplement
020280009AP1998/01/27Control Supplement
020280008AP1997/10/31New or Modified Indication
020280007AP1996/10/23Control Supplement
020280006AP1996/11/19Control Supplement
020280005AP1996/07/15Manufacturing Change or Addition
020280004AP1996/05/24Control Supplement
020280003AP1996/04/19Labeling Revision
020280002AP1996/04/24Manufacturing Change or Addition
020280001AP1995/12/20Labeling Revision
020280000AP1995/08/24Approval