药品名称AMICAR
申请号015197产品号002
活性成分AMINOCAPROIC ACID市场状态处方药
剂型或给药途径TABLET;ORAL规格1GM
治疗等效代码参比药物
批准日期2004/06/24申请机构CLOVER PHARMACEUTICALS CORP
化学类型New molecular entity (NME)审评分类Priority 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
015197043APLetter2008/08/22下载
015197043APLabel2008/08/26下载
015197040APLetter2004/08/25下载
015197039APLetter2004/06/25下载
015197039APLabel2004/06/25下载
015197038APLabel2004/06/25下载
015197038APLetter2004/06/25下载
015197037APLabel2004/06/25下载
015197037APLetter2004/06/25下载
015197036APLetter2004/06/25下载
015197036APLabel2004/06/25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
015197043AP2008/08/19Labeling Revision
015197040AP2004/08/24Labeling Revision
015197039AP2004/06/24Manufacturing Change or Addition
015197038AP2004/06/24Package Change
015197037AP2004/06/24Formulation Revision
015197036AP2004/06/24Manufacturing Change or Addition
015197035AP2000/11/27Manufacturing Change or Addition
015197034AP2000/04/03Labeling Revision
015197033AP2000/10/02Control Supplement
015197032AP1999/10/01Control Supplement
015197030AP1997/04/16Labeling Revision
015197029AP1992/02/11Package Change
015197028AP1992/08/13Expiration Date Change
015197027AP1986/01/17Labeling Revision
015197026AP1983/06/06Labeling Revision
015197025AP1982/12/10Labeling Revision
015197024AP1982/09/22Package Change
015197023AP1990/04/03Labeling Revision
015197022AP1982/10/22Control Supplement
015197019AP1981/06/30Formulation Revision
015197015AP1977/02/09Formulation Revision
015197000AP1964/06/03Approval