药品名称TRINALIN
申请号018506产品号001
活性成分AZATADINE MALEATE; PSEUDOEPHEDRINE SULFATE市场状态停止上市
剂型或给药途径TABLET, EXTENDED RELEASE;ORAL规格1MG;120MG
治疗等效代码参比药物
批准日期1982/03/23申请机构SCHERING CORP SUB SCHERING PLOUGH CORP
化学类型New combination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
018506025APLetter2002/12/12下载
018506024APLetter2002/11/01下载
018506022APReview2007/03/02下载
018506018APReview2007/03/02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
018506025AP2002/12/12Labeling Revision
018506024AP2002/11/01Labeling Revision
018506022AP2000/11/01Control Supplement
018506021AP2000/08/04Control Supplement
018506019AP2000/04/25Control Supplement
018506018AP2000/09/13Control Supplement
018506016AP1998/05/18Control Supplement
018506015AP1992/07/01Manufacturing Change or Addition
018506014AP1992/04/20Control Supplement
018506012AP1989/01/24Control Supplement
018506011AP1989/01/24Manufacturing Change or Addition
018506010AP1988/04/06Manufacturing Change or Addition
018506009AP1987/05/01Manufacturing Change or Addition
018506008AP1986/07/08Control Supplement
018506007AP1985/07/02Control Supplement
018506005AP1984/09/18Package Change
018506004AP1985/03/04Control Supplement
018506003AP1984/08/31Control Supplement
018506002AP1984/02/24Control Supplement
018506001AP1985/02/06Control Supplement
018506000AP1982/03/23Approval