药品名称CONRAY 43
申请号013295产品号002
活性成分IOTHALAMATE MEGLUMINE市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格43%
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构LIEBEL-FLARSHEIM CO LLC
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
013295068APLabel2015/07/09下载
013295068APLetter2015/07/10下载
013295066APLetter2014/07/10下载
013295060APLetter2003/06/22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
013295069AP2016/06/22Manufacturing Change or Addition
013295068AP2015/07/06Labeling Revision
013295067AP2015/02/03Manufacturing Change or Addition
013295066AP2014/07/08Labeling Revision
013295065AP2014/02/25Manufacturing Change or Addition
013295064AP2013/12/19Manufacturing Change or Addition
013295063AP2013/07/23Manufacturing Change or Addition
013295062AP2013/05/30Manufacturing Change or Addition
013295061AP2013/05/10Manufacturing Change or Addition
013295060AP2003/06/13Labeling Revision
013295059AP2001/02/26Package Change
013295058AP1999/10/27Formulation Revision
013295057AP1995/01/13Labeling Revision
013295056AP1992/08/28Package Change
013295055AP1992/12/04Control Supplement
013295054AP1990/03/30Control Supplement
013295053AP1989/06/28Labeling Revision
013295052AP1989/12/01Control Supplement
013295051AP1988/08/19Control Supplement
013295050AP1989/10/10Package Change
013295049AP1986/12/18Labeling Revision
013295048AP1985/04/08Package Change
013295047AP1985/09/09General Efficacy (MarkIV)
013295046AP1984/10/25Labeling Revision
013295045AP1984/09/12Labeling Revision
013295044AP1989/06/28Package Change
013295043AP1989/10/10Package Change
013295042AP1984/12/04Control Supplement
013295041AP1984/06/25Manufacturing Change or Addition
013295040AP1984/06/19Labeling Revision
013295039AP1982/10/20Package Change
013295038AP1982/10/22Labeling Revision
013295036AP1983/01/26Labeling Revision
013295034AP1983/02/25Labeling Revision
013295033AP1983/01/26General Efficacy (MarkIV)
013295032AP1979/12/07Labeling Revision
013295031AP1982/10/20General Efficacy (MarkIV)
013295030AP1978/10/20Package Change
013295029AP1978/08/29Control Supplement
013295028AP1978/10/17Control Supplement
013295027AP1978/10/17General Efficacy (MarkIV)
013295026AP1978/10/17Package Change
013295025AP1978/10/17Labeling Revision
013295024AP1976/05/05Labeling Revision
013295023AP1976/05/06Control Supplement
013295022AP1976/01/23Control Supplement
013295021AP1976/01/23Control Supplement
013295020AP1975/07/30Control Supplement
013295013AP1975/08/22Final Printed Labeling - MarkIV
013295000AP1962/08/16Approval