药品名称ACULAR
申请号019700产品号001
活性成分KETOROLAC TROMETHAMINE市场状态处方药
剂型或给药途径SOLUTION/DROPS;OPHTHALMIC规格0.5%
治疗等效代码AT参比药物
批准日期1992/11/09申请机构ALLERGAN 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
51104932009/05/05U-75PDF格式
5110493*PED2009/11/05U-75PDF格式
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
019700028APLetter2012/06/18下载
019700028APLabel2012/06/18下载
019700024APLabel2005/03/11下载
019700024APLetter2005/03/11下载
019700023APLabel2005/03/11下载
019700023APLetter2005/03/11下载
019700019APLetter2002/02/08下载
019700019APLabel2002/02/08下载
019700019APReview2009/01/12下载
019700018APLabel2003/06/16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
019700028AP2012/06/14Labeling Revision
019700024AP2005/03/10Labeling Revision
019700023AP2005/03/10Package Change
019700022AP2002/04/12Manufacturing Change or Addition
019700021AP2002/04/15Package Change
019700020AP2001/12/04Manufacturing Change or Addition
019700019AP2002/02/08Patient Population Altered
019700018AP2001/07/16Manufacturing Change or Addition
019700017AP2001/04/12Manufacturing Change or Addition
019700016AP2000/10/02Manufacturing Change or Addition
019700014AP2001/04/27Labeling Revision
019700013AP1998/02/04Control Supplement
019700012AP1998/05/19Control Supplement
019700011AP1997/07/21Manufacturing Change or Addition
019700009AP1997/04/30Control Supplement
019700007AP1996/12/31New or Modified Indication
019700006AP1996/07/11Control Supplement
019700005AP1996/09/18Control Supplement
019700004AP1996/09/18Labeling Revision
019700003AP1996/09/18New Dosage Regimen
019700002AP1996/03/29Control Supplement
019700001AP1994/04/14Manufacturing Change or Addition
019700000AP1992/11/09Approval