药品名称AN-SULFUR COLLOID
申请号017858产品号001
活性成分TECHNETIUM TC-99M SULFUR COLLOID KIT市场状态处方药
剂型或给药途径SOLUTION;INJECTION, ORAL规格N/A
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构PHARMALUCENCE INC
化学类型New formulation or new manufacturer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
ODE2019/08/13
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
017858035APLabel2012/08/15下载
017858035APLetter2012/08/16下载
017858035APReview2012/09/12下载
017858034APLetter2011/07/26下载
017858034APLabel2011/07/27下载
017858024APLetter2002/09/13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
017858045AP2015/12/04Manufacturing Change or Addition
017858044AP2015/09/28Manufacturing Change or Addition
017858043AP2015/09/22Manufacturing Change or Addition
017858042AP2015/08/13Manufacturing Change or Addition
017858040AP2016/04/22Manufacturing Change or Addition
017858039AP2014/09/12Manufacturing Change or Addition
017858038AP2013/12/04Manufacturing Change or Addition
017858037AP2012/12/14Manufacturing Change or Addition
017858035AP2012/08/13New or Modified Indication
017858034AP2011/07/22Efficacy Supplement with Clinical Data to Support
017858024AP2002/09/13Labeling Revision
017858023AP1998/08/04Package Change
017858021AP1995/08/25Control Supplement
017858020AP1989/09/22Labeling Revision
017858019AP1986/04/02Manufacturing Change or Addition
017858017AP1985/08/02Manufacturing Change or Addition
017858015AP1986/09/12General Efficacy (MarkIV)
017858014AP1985/04/29Manufacturing Change or Addition
017858012AP1984/09/10Control Supplement
017858008AP1981/11/16Control Supplement
017858007AP1985/02/26Practioner Draft Labeling
017858005AP1982/01/11Labeling Revision
017858004AP1982/06/30Control Supplement
017858002AP1982/01/27Labeling Revision
017858001AP1980/05/11Control Supplement
017858000AP1978/04/17Approval