药品名称CYSTOGRAFIN DILUTE
申请号010040产品号022
活性成分DIATRIZOATE MEGLUMINE市场状态处方药
剂型或给药途径SOLUTION;URETHRAL规格18%
治疗等效代码参比药物
批准日期1982/11/09申请机构BRACCO DIAGNOSTICS INC
化学类型审评分类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
010040171APLetter2015/07/10下载
010040171APLabel2015/07/13下载
010040168APLetter2002/10/23下载
010040163APLetter2003/10/01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
010040171AP2015/07/06Labeling Revision
010040168AP2002/10/23Labeling Revision
010040167AP2000/06/29Manufacturing Change or Addition
010040166AP1994/09/09Labeling Revision
010040163AP2003/09/25Practioner Draft Labeling
010040162AP1989/07/07Labeling Revision
010040160AP1987/06/08Control Supplement
010040159AP1985/11/25Labeling Revision
010040158AP1985/07/23Labeling Revision
010040157AP1985/07/23Labeling Revision
010040156AP1985/06/06Labeling Revision
010040155AP1985/06/05Labeling Revision
010040154AP1985/06/06Labeling Revision
010040153AP1985/07/23Labeling Revision
010040152AP1985/07/23Labeling Revision
010040151AP1985/06/06Labeling Revision
010040150AP1985/07/23Labeling Revision
010040149AP1985/06/12Labeling Revision
010040148AP1985/06/12Labeling Revision
010040147AP1985/06/06Labeling Revision
010040146AP1985/06/12Labeling Revision
010040145AP1985/01/28Manufacturing Change or Addition
010040144AP1985/05/23Manufacturing Change or Addition
010040143AP1984/04/03General Efficacy (MarkIV)
010040142AP1985/05/23Manufacturing Change or Addition
010040140AP1983/02/02Labeling Revision
010040139AP1984/01/06Package Change
010040138AP1985/01/14Control Supplement
010040137AP1982/11/09Control Supplement
010040135AP1982/02/24Control Supplement
010040134AP1991/03/05Formulation Revision
010040122AP1982/03/31Labeling Revision
010040121AP1982/09/27General Efficacy (MarkIV)
010040120AP1981/07/01Control Supplement
010040118AP1980/08/01Final Printed Labeling - MarkIV
010040117AP1980/06/04Labeling Revision
010040116AP1980/07/01Labeling Revision
010040115AP1980/06/20Labeling Revision
010040114AP1980/04/14Labeling Revision
010040113AP1980/06/04Labeling Revision
010040111AP1982/06/30Labeling Revision
010040110AP1980/03/14Labeling Revision
010040109AP1983/01/26Labeling Revision
010040108AP1979/08/03Control Supplement
010040107AP1983/07/10General Efficacy (MarkIV)
010040105AP1982/06/30Labeling Revision
010040103AP1980/06/30Labeling Revision
010040102AP1979/06/08Labeling Revision
010040101AP1979/06/08Labeling Revision
010040100AP1979/06/08Labeling Revision
010040099AP1980/01/24Control Supplement
010040098AP1979/10/12Labeling Revision
010040097AP1979/10/12Labeling Revision
010040096AP1979/09/13Labeling Revision
010040095AP1980/03/19Labeling Revision
010040094AP1979/09/13Labeling Revision
010040093AP1979/06/26Labeling Revision
010040092AP1979/02/16Control Supplement
010040091AP1978/12/28Formulation Revision
010040089AP1978/02/23Control Supplement
010040088AP1978/09/15Control Supplement
010040087AP1978/03/14Labeling Revision
010040086AP1977/11/01Labeling Revision
010040085AP1977/10/21Labeling Revision
010040083AP1979/03/30Control Supplement
010040082AP1977/01/11Labeling (MarkIV)
010040081AP1977/01/11Control Supplement
010040080AP1977/01/11Package Change
010040079AP1976/12/06Labeling Revision
010040078AP1977/08/22Labeling Revision
010040077AP1976/12/14Package Change
010040076AP1976/12/02Labeling Revision
010040075AP1978/01/31Labeling Revision
010040074AP1976/09/13Labeling Revision
010040073AP1976/09/10Labeling Revision
010040072AP1976/09/10Labeling Revision
010040071AP1976/09/06Labeling Revision
010040070AP1976/09/13Labeling Revision
010040069AP1976/09/13Labeling Revision
010040068AP1976/09/09Labeling Revision
010040067AP1976/09/10Labeling Revision
010040066AP1976/05/26Control Supplement
010040065AP1976/06/16Labeling Revision
010040064AP1976/05/06Expiration Date Change
010040063AP1976/05/06Labeling Revision
010040062AP1976/05/05Labeling Revision
010040061AP1976/05/05Labeling Revision
010040059AP1976/05/05Expiration Date Change
010040058AP1976/05/06Labeling Revision
010040057AP1976/05/06Labeling Revision
010040056AP1975/09/24Control Supplement
010040055AP1975/09/30Labeling Revision
010040054AP1975/09/30Labeling Revision
010040053AP1975/05/27Other Amendment
010040033AP1977/06/17Control Supplement
010040000AP1955/08/02Approval