药品名称ETRAFON-FORTE
申请号014713产品号006
活性成分AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE市场状态停止上市
剂型或给药途径TABLET;ORAL规格25MG;4MG
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构SCHERING CORP SUB SCHERING PLOUGH CORP
化学类型New formulation or new manufacturer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
014713032APLetter2002/05/10下载
014713031APLetter2002/05/10下载
014713000APOther Important Information from FDA2007/05/09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
014713032AP2002/05/10Labeling Revision
014713031AP2002/05/10Labeling Revision
014713030AP2001/03/02Control Supplement
014713029AP2000/08/18Control Supplement
014713028AP2000/03/03Control Supplement
014713027AP1999/09/10Control Supplement
014713026AP2000/05/23Formulation Revision
014713025AP1998/08/21Control Supplement
014713024AP2000/08/23Labeling Revision
014713023AP2000/08/23Labeling Revision
014713020AP1988/08/03Control Supplement
014713018AP1984/12/07Manufacturing Change or Addition
014713017AP1984/08/15Package Change
014713014AP1981/02/17Formulation Revision
014713012AP1980/02/14Package Change
014713011AP1980/01/29Formulation Revision
014713010AP1979/02/06Labeling Revision
014713000AP1969/09/17Approval