药品名称BETOPTIC
申请号019270产品号001
活性成分BETAXOLOL HYDROCHLORIDE市场状态处方药
剂型或给药途径SOLUTION/DROPS;OPHTHALMIC规格EQ 0.5% BASE
治疗等效代码AT参比药物
批准日期1985/08/30申请机构ALCON LABORATORIES INC
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
019270031APLabel2006/02/22下载
019270031APLetter2006/02/22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
019270038AP2016/08/05Manufacturing Change or Addition
019270037AP2016/05/05Manufacturing Change or Addition
019270036AP2016/05/05Manufacturing Change or Addition
019270035AP2015/05/11Manufacturing Change or Addition
019270034AP2014/09/25Manufacturing Change or Addition
019270031AP2006/02/14Labeling Revision
019270029AP2002/12/04Control Supplement
019270028AP2002/03/13Control Supplement
019270027AP2001/03/16Control Supplement
019270026AP2000/02/18Manufacturing Change or Addition
019270025AP1999/08/17Control Supplement
019270024AP1999/04/07Manufacturing Change or Addition
019270023AP1999/03/26Package Change
019270022AP1999/02/05Manufacturing Change or Addition
019270021AP1999/03/11Control Supplement
019270020AP1998/08/04Control Supplement
019270019AP1998/01/15Manufacturing Change or Addition
019270018AP1995/11/01Control Supplement
019270017AP1995/11/01Control Supplement
019270016AP1993/01/22Manufacturing Change or Addition
019270015AP1991/04/10Package Change
019270014AP1991/02/14Control Supplement
019270013AP1990/07/09Package Change
019270012AP1989/07/19Manufacturing Change or Addition
019270011AP1991/10/28Labeling Revision
019270010AP1988/08/31Manufacturing Change or Addition
019270009AP1988/07/13Manufacturing Change or Addition
019270008AP1987/09/24Control Supplement
019270007AP1986/07/07Package Change
019270006AP1986/11/04Manufacturing Change or Addition
019270004AP1986/05/27Control Supplement
019270002AP1985/12/12Package Change
019270001AP1985/12/12Manufacturing Change or Addition
019270000AP1985/08/30Approval