药品名称OPTIRAY 300
申请号019710产品号004
活性成分IOVERSOL市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格64%
治疗等效代码参比药物
批准日期1992/01/22申请机构LIEBEL-FLARSHEIM CO LLC
化学类型New molecular entity (NME)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
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
019710052APLabel2015/07/09下载
019710052APLetter2015/07/10下载
019710039APLabel2016/08/17下载
019710039APLetter2016/08/18下载
019710034APLetter2008/04/30下载
019710032APLetter2008/04/28下载
019710021APReview1997/05/23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
019710053AP2016/05/13Manufacturing Change or Addition
019710052AP2015/07/06Labeling Revision
019710051AP2013/12/06Manufacturing Change or Addition
019710050AP2013/12/19Manufacturing Change or Addition
019710039AP2016/08/12Labeling Revision
019710035AP2009/08/08Labeling Revision
019710034AP2008/04/25Labeling Revision
019710032AP2008/04/25Labeling Revision
019710027AP2001/08/02Control Supplement
019710026AP2001/09/12Manufacturing Change or Addition
019710025AP2001/01/23Package Change
019710024AP1999/10/27Formulation Revision
019710023AP1999/04/16Manufacturing Change or Addition
019710022AP1999/03/25Manufacturing Change or Addition
019710021AP1997/05/23Manufacturing Change or Addition
019710019AP1995/01/13Labeling Revision
019710018AP1995/06/21New or Modified Indication
019710017AP1993/07/27New or Modified Indication
019710016AP1993/03/09New or Modified Indication
019710013AP1996/07/12Package Change
019710012AP1992/12/11New or Modified Indication
019710011AP1992/10/26Manufacturing Change or Addition
019710010AP1993/09/22Manufacturing Change or Addition
019710009AP1992/08/28Package Change
019710008AP1992/12/04Control Supplement
019710007AP1992/07/09New or Modified Indication
019710005AP1992/01/22Control Supplement
019710004AP1992/01/22New or Modified Indication
019710003AP1990/03/30Control Supplement
019710002AP1989/10/10Package Change
019710001AP1989/04/17Labeling Revision
019710000AP1988/12/30Approval