药品名称KLOR-CON
申请号019123产品号002
活性成分POTASSIUM CHLORIDE市场状态处方药
剂型或给药途径TABLET, EXTENDED RELEASE;ORAL规格10MEQ
治疗等效代码AB2参比药物
批准日期1986/04/17申请机构UPSHER-SMITH LABORATORIES 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
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
019123024APLetter2006/04/20下载
019123022APLetter2004/05/27下载
019123021APLetter2003/11/25下载
019123000APReview2010/03/16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
019123035AP2016/08/29Manufacturing Change or Addition
019123034AP2013/11/29Manufacturing Change or Addition
019123024AP2006/04/13Labeling Revision
019123022AP2004/05/24Labeling Revision
019123021AP2003/11/21Labeling Revision
019123019AP1996/07/18Package Change
019123018AP1995/07/18Control Supplement
019123017AP1994/04/08Manufacturing Change or Addition
019123016AP1994/12/16Manufacturing Change or Addition
019123015AP1993/07/02Package Change
019123014AP1991/10/31Control Supplement
019123013AP1990/07/17Formulation Revision
019123012AP1989/09/21Control Supplement
019123011AP1990/07/18Control Supplement
019123010AP1989/09/18Control Supplement
019123009AP1989/07/24Control Supplement
019123008AP1992/06/26Comparative Efficacy Claim
019123007AP1988/11/07Manufacturing Change or Addition
019123006AP1988/06/02Labeling Revision
019123005AP1987/07/31Control Supplement
019123004AP1987/08/25Package Change
019123003AP1987/06/26Manufacturing Change or Addition
019123002AP1987/04/17Formulation Revision
019123000AP1986/04/17Approval