药品名称BETAGAN
申请号019219产品号002
活性成分LEVOBUNOLOL HYDROCHLORIDE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1985/12/19申请机构ALLERGAN PHARMACEUTICAL
化学类型New molecular entity (NME)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
019219020APLabel2003/04/15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
019219028AP2015/12/16Manufacturing Change or Addition
019219023AP2002/04/12Manufacturing Change or Addition
019219022AP2001/12/04Manufacturing Change or Addition
019219021AP2001/04/12Manufacturing Change or Addition
019219020AP2001/08/08Manufacturing Change or Addition
019219019AP2001/05/14Labeling Revision
019219018AP2000/10/02Manufacturing Change or Addition
019219017AP1998/05/19Control Supplement
019219016AP1998/05/01Control Supplement
019219015AP1998/02/12Manufacturing Change or Addition
019219014AP1995/06/12Manufacturing Change or Addition
019219013AP1995/08/03Control Supplement
019219012AP1994/01/13Control Supplement
019219011AP1992/02/03Labeling Revision
019219010AP1990/01/31Labeling Revision
019219009AP1989/12/06Package Change
019219007AP1989/12/04Labeling Revision
019219005AP1988/11/09Labeling Revision
019219004AP1988/10/21Control Supplement
019219003AP1987/08/13Labeling Revision
019219002AP1987/09/15Control Supplement
019219000AP1985/12/19Approval