药品名称ROCEPHIN KIT
申请号050585产品号006
活性成分CEFTRIAXONE SODIUM; LIDOCAINE市场状态停止上市
剂型或给药途径INJECTABLE;INJECTION规格EQ 1GM BASE/VIAL,N/A;N/A,1%
治疗等效代码参比药物
批准日期1996/05/08申请机构HOFFMANN LA ROCHE INC
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
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
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
050585067APLabel2015/07/01下载
050585067APLetter2015/07/08下载
050585066APLabel2015/03/23下载
050585066APLetter2015/03/24下载
050585065APLetter2013/04/16下载
050585065APLabel2013/04/16下载
050585064APLabel2010/03/03下载
050585064APLetter2010/03/04下载
050585063APLabel2009/06/10下载
050585063APLetter2009/06/16下载
050585062APLabel2010/11/17下载
050585062APLetter2010/11/18下载
050585061APLetter2009/03/13下载
050585061APLabel2009/04/03下载
050585060APLetter2008/08/20下载
050585060APLabel2008/08/26下载
050585059APLetter2007/05/16下载
050585059APLabel2007/05/16下载
050585058APLetter2007/07/24下载
050585058APLabel2007/07/24下载
050585057APLetter2004/09/15下载
050585057APLabel2004/09/15下载
050585056APLabel2004/09/03下载
050585056APLetter2004/09/03下载
050585054APLabel2004/04/05下载
050585054APLetter2004/04/07下载
050585050APLabel2008/08/26下载
050585000APOther Important Information from FDA2007/09/11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
050585067AP2015/06/30Labeling Revision
050585066AP2015/03/20Labeling Revision
050585065AP2013/04/12Labeling Revision
050585064AP2010/02/25Labeling Revision
050585063AP2009/06/07Labeling Revision
050585062AP2010/11/12Labeling Revision
050585061AP2009/03/11Labeling Revision
050585060AP2008/08/18Labeling Revision
050585059AP2007/05/11Labeling Revision
050585058AP2007/07/17Labeling Revision
050585057AP2004/09/14Supplement
050585056AP2004/09/02Labeling Revision
050585054AP2004/03/29Labeling Revision
050585050AP2008/08/18Labeling Revision
050585049AP1999/10/18Control Supplement
050585048AP1998/04/28Control Supplement
050585047AP2000/08/25Labeling Revision
050585046AP1997/12/23New Dosage Regimen
050585045AP1995/09/14Labeling Revision
050585044AP1996/05/08New Dosage Regimen
050585043AP1994/08/18Labeling Revision
050585042AP1994/02/04Manufacturing Change or Addition
050585041AP1993/02/08Manufacturing Change or Addition
050585039AP1994/04/26Labeling Revision
050585037AP1996/03/14Manufacturing Change or Addition
050585036AP1992/09/23Control Supplement
050585035AP1992/06/17New or Modified Indication
050585034AP1993/05/28New Dosage Regimen
050585033AP1993/10/07Labeling Revision
050585031AP1991/09/12Manufacturing Change or Addition
050585030AP1992/01/31Control Supplement
050585029AP1992/02/04Manufacturing Change or Addition
050585027AP1990/12/31New or Modified Indication
050585026AP1991/03/11Labeling Revision
050585025AP1991/03/11Chemistry Generic
050585023AP1992/02/11New or Modified Indication
050585022AP1989/06/29Chemistry Generic
050585021AP1989/02/07Chemistry Generic
050585019AP1988/08/26Chemistry Generic
050585018AP1991/03/11Labeling Revision
050585015AP1989/09/25Labeling Revision
050585011AP1986/10/07Chemistry Generic
050585010AP1986/10/07Chemistry Generic
050585009AP1991/11/22New Dosage Regimen
050585004AP1985/05/10Labeling Revision
050585000AP1984/12/21Approval