药品名称SANDOSTATIN
申请号019667产品号004
活性成分OCTREOTIDE ACETATE市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格EQ 0.2MG BASE/ML
治疗等效代码AP参比药物
批准日期1991/06/12申请机构NOVARTIS PHARMACEUTICALS CORP
化学类型New molecular entity (NME)审评分类Priority 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
5753618*PED2015/11/19PDF格式
历史专利信息
57536182015/05/19PDF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
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
019667062APLetter2015/02/24下载
019667062APLabel2015/03/12下载
019667061APLetter2012/03/27下载
019667061APLabel2012/03/27下载
019667059APLetter2014/02/11下载
019667058APLabel2010/02/04下载
019667058APLetter2010/02/05下载
019667054APLetter2008/08/28下载
019667054APLabel2008/08/29下载
019667050APLabel2005/09/08下载
019667050APLetter2005/09/08下载
019667044APLetter2003/01/17下载
019667044APLabel2003/01/17下载
019667042APLetter2003/02/10下载
019667032APLetter2002/07/24下载
019667028APLetter2002/07/24下载
019667004APReview1999/02/19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
019667062AP2015/02/20Labeling Revision
019667061AP2012/03/23Labeling Revision
019667059AP2014/02/04Manufacturing Change or Addition
019667058AP2010/01/25Labeling Revision
019667054AP2008/08/26Labeling Revision
019667050AP2005/09/02Labeling Revision
019667044AP2003/01/17Manufacturing Change or Addition
019667043AP2002/05/28Package Change
019667042AP2003/02/10Manufacturing Change or Addition
019667041AP2002/05/13Manufacturing Change or Addition
019667040AP2002/01/03Manufacturing Change or Addition
019667039AP2001/06/21Manufacturing Change or Addition
019667038AP2001/07/02Labeling Revision
019667036AP1999/02/17Manufacturing Change or Addition
019667035AP1999/02/17Manufacturing Change or Addition
019667034AP1998/07/31Manufacturing Change or Addition
019667033AP1998/12/17Control Supplement
019667032AP2002/07/24Labeling Revision
019667031AP1997/10/24Expiration Date Change
019667030AP1997/10/24Control Supplement
019667029AP1997/10/24Control Supplement
019667028AP2002/07/24Labeling Revision
019667027AP1997/10/24Control Supplement
019667026AP1996/10/21Control Supplement
019667025AP1996/08/14Control Supplement
019667024AP1996/07/16Control Supplement
019667023AP1996/06/12Manufacturing Change or Addition
019667022AP1996/02/16Control Supplement
019667021AP1994/12/06Formulation Revision
019667020AP1995/12/18Formulation Revision
019667019AP1995/02/06Control Supplement
019667017AP1994/05/03New or Modified Indication
019667016AP1993/01/12Control Supplement
019667015AP1992/09/30Manufacturing Change or Addition
019667014AP1992/07/31Labeling Revision
019667012AP1995/10/10Control Supplement
019667011AP1995/11/07Control Supplement
019667010AP1992/02/28Control Supplement
019667008AP1991/10/04Labeling Revision
019667007AP1991/07/03Labeling Revision
019667005AP1990/04/16Labeling Revision
019667004AP1991/06/12Control Supplement
019667003AP1989/06/23Control Supplement
019667000AP1988/10/21Approval