药品名称TIMOPTIC IN OCUDOSE
申请号019463产品号001
活性成分TIMOLOL MALEATE市场状态处方药
剂型或给药途径SOLUTION/DROPS;OPHTHALMIC规格EQ 0.25% BASE
治疗等效代码参比药物
批准日期1986/11/05申请机构ATON PHARMA INC
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
019463028APLabel2011/09/30下载
019463028APLetter2011/10/03下载
019463027APLabel2006/06/06下载
019463027APLetter2006/06/08下载
019463026APLetter2003/12/24下载
019463026APLabel2003/12/29下载
019463026APReview2006/05/08下载
019463022APLabel2003/04/15下载
019463019APReview2003/09/11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
019463030AP2015/08/14Manufacturing Change or Addition
019463028AP2011/09/30Labeling Revision
019463027AP2006/06/05Labeling Revision
019463026AP2003/12/22Labeling Revision
019463024AP2002/07/26Control Supplement
019463023AP2001/12/04Manufacturing Change or Addition
019463022AP2001/12/07Labeling Revision
019463021AP2000/03/02Manufacturing Change or Addition
019463020AP2000/03/02Labeling Revision
019463019AP1998/03/18Labeling Revision
019463018AP1997/06/22Control Supplement
019463017AP1998/08/14Manufacturing Change or Addition
019463016AP1996/12/02Control Supplement
019463015AP1996/12/02Manufacturing Change or Addition
019463014AP1998/04/22Manufacturing Change or Addition
019463013AP1997/05/16Labeling Revision
019463012AP1995/07/10Control Supplement
019463011AP1995/01/18Labeling Revision
019463009AP1993/12/09Labeling Revision
019463006AP1993/03/25Control Supplement
019463005AP1992/05/21Labeling Revision
019463004AP1992/05/21Labeling Revision
019463003AP1990/07/09Control Supplement
019463001AP1989/08/09Manufacturing Change or Addition
019463000AP1986/11/05Approval