药品名称CYSTO-CONRAY II
申请号017057产品号002
活性成分IOTHALAMATE MEGLUMINE市场状态处方药
剂型或给药途径SOLUTION;INTRAVESICAL规格17.2%
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 dosage form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
017057027APLetter2002/09/13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
017057031AP2013/12/19Manufacturing Change or Addition
017057029AP2013/05/30Manufacturing Change or Addition
017057028AP2013/05/10Manufacturing Change or Addition
017057027AP2002/09/13Labeling Revision
017057026AP1999/10/27Formulation Revision
017057025AP1995/01/13Labeling Revision
017057024AP1992/08/28Package Change
017057023AP1992/12/04Control Supplement
017057022AP1990/03/30Control Supplement
017057021AP1989/12/01Control Supplement
017057020AP1987/07/08Package Change
017057019AP1989/06/28Package Change
017057018AP1989/10/10Package Change
017057017AP1984/12/04Control Supplement
017057016AP1984/06/26Manufacturing Change or Addition
017057015AP1983/07/08Practioner Draft Labeling
017057013AP1978/09/06Control Supplement
017057012AP1976/09/14Package Change
017057011AP1976/09/14Package Change
017057010AP1976/05/05Labeling Revision
017057009AP1976/05/05Control Supplement
017057008AP1976/01/23Control Supplement
017057007AP1976/01/23Control Supplement
017057006AP1975/07/30Control Supplement
017057000AP1972/04/17Approval