药品名称MICRO-K 10
申请号018238产品号002
活性成分POTASSIUM CHLORIDE市场状态处方药
剂型或给药途径CAPSULE, EXTENDED RELEASE;ORAL规格10MEQ
治疗等效代码AB参比药物
批准日期1984/05/14申请机构NESHER PHARMACEUTICALS USA 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
018238031APLetter2003/08/25下载
018238013APReview2009/01/12下载
018238011APReview2009/01/12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
018238045AP2016/03/09Manufacturing Change or Addition
018238044AP2015/02/03Manufacturing Change or Addition
018238043AP2014/11/26Manufacturing Change or Addition
018238042AP2014/06/12Manufacturing Change or Addition
018238041AP2013/07/18Manufacturing Change or Addition
018238040AP2013/03/25Manufacturing Change or Addition
018238039AP2013/03/14Manufacturing Change or Addition
018238031AP2003/08/20Labeling Revision
018238029AP2000/05/08Manufacturing Change or Addition
018238028AP2000/07/10Manufacturing Change or Addition
018238027AP2000/03/09Manufacturing Change or Addition
018238026AP1998/01/13Manufacturing Change or Addition
018238025AP1993/08/19Manufacturing Change or Addition
018238024AP1990/03/12Manufacturing Change or Addition
018238023AP1998/01/30Labeling Revision
018238022AP1998/01/30Labeling Revision
018238021AP1988/06/30Package Change
018238020AP1987/12/10Control Supplement
018238019AP1987/06/26Package Change
018238018AP1986/10/23Control Supplement
018238017AP1986/02/14Manufacturing Change or Addition
018238016AP1985/11/25Formulation Revision
018238014AP1985/08/08Control Supplement
018238013AP1985/07/25Package Change
018238012AP1984/03/16Formulation Revision
018238011AP1984/05/14General Efficacy (MarkIV)
018238010AP1983/05/04Control Supplement
018238009AP1983/08/03Control Supplement
018238007AP1982/08/23Other Amendment
018238006AP1982/03/03Formulation Revision
018238005AP1982/03/03Formulation Revision
018238004AP1982/03/08Package Change
018238003AP1982/02/17Package Change
018238002AP1981/06/02Control Supplement
018238001AP1981/02/13Manufacturing Change or Addition
018238000AP1980/10/17Approval