药品名称NORMODYNE
申请号018687产品号003
活性成分LABETALOL HYDROCHLORIDE市场状态停止上市
剂型或给药途径TABLET;ORAL规格300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
治疗等效代码参比药物
批准日期1984/08/01申请机构SCHERING CORP SUB SCHERING PLOUGH CORP
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
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
018687023AP2000/12/22Manufacturing Change or Addition
018687022AP2000/10/27Manufacturing Change or Addition
018687021AP2000/04/25Labeling Revision
018687020AP2000/01/27Manufacturing Change or Addition
018687019AP1993/05/28Control Supplement
018687018AP1993/01/27Package Change
018687017AP1991/09/16Control Supplement
018687016AP1992/10/15Labeling Revision
018687015AP1990/11/07Labeling Revision
018687014AP1989/06/16Labeling Revision
018687013AP1988/11/22Control Supplement
018687012AP1989/06/16Labeling Revision
018687011AP1989/02/23Manufacturing Change or Addition
018687010AP1988/04/14Labeling Revision
018687009AP1987/02/05Manufacturing Change or Addition
018687008AP1987/08/31Labeling Revision
018687007AP1986/08/08Control Supplement
018687006AP1986/01/14Control Supplement
018687005AP1987/08/31Labeling Revision
018687003AP1985/06/28Control Supplement
018687002AP1987/08/31Labeling Revision
018687000AP1984/08/01Approval