药品名称CYKLOKAPRON
申请号019281产品号001
活性成分TRANEXAMIC ACID市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格100MG/ML
治疗等效代码AP参比药物
批准日期1986/12/30申请机构PHARMACIA AND UPJOHN CO
化学类型New dosage form审评分类Standard review drug
罕用药/孤儿药
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
019281033APLabel2015/04/14下载
019281031APLabel2013/05/14下载
019281031APLetter2013/05/14下载
019281030APLabel2011/01/31下载
019281030APLetter2011/02/02下载
019281027APLetter2009/01/30下载
019281025APLetter2008/12/24下载
019281025APLabel2009/01/02下载
019281013APLetter2001/03/27下载
019281009APReview2001/06/18下载
019281009APLetter1999/09/09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
019281040AP2016/08/01Manufacturing Change or Addition
019281039AP2016/08/29Manufacturing Change or Addition
019281037AP2016/02/01Manufacturing Change or Addition
019281036AP2015/10/20Manufacturing Change or Addition
019281035AP2015/06/01Manufacturing Change or Addition
019281034AP2015/04/17Manufacturing Change or Addition
019281033AP2014/12/15Manufacturing Change or Addition
019281031AP2013/05/10Labeling Revision
019281030AP2011/01/25Labeling Revision
019281027AP2009/01/28Labeling Revision
019281025AP2008/12/22Labeling Revision
019281019AP2002/05/15Manufacturing Change or Addition
019281018AP2002/04/16Control Supplement
019281017AP2001/11/02Package Change
019281016AP2001/11/02Manufacturing Change or Addition
019281015AP2001/10/31Labeling Revision
019281013AP2001/03/27Labeling Revision
019281012AP2001/07/31Manufacturing Change or Addition
019281011AP2000/04/28Control Supplement
019281010AP1999/11/15Control Supplement
019281009AP1999/09/09Labeling Revision
019281008AP1996/07/24Manufacturing Change or Addition
019281007AP1996/07/24Control Supplement
019281006AP1994/11/07Control Supplement
019281005AP1996/07/24Manufacturing Change or Addition
019281004AP1996/07/24Control Supplement
019281003AP1996/12/05Control Supplement
019281002AP1994/11/07Control Supplement
019281001AP1996/07/24Manufacturing Change or Addition
019281000AP1986/12/30Approval