药品名称LUDIOMIL
申请号017543产品号001
活性成分MAPROTILINE HYDROCHLORIDE市场状态停止上市
剂型或给药途径TABLET;ORAL规格25MG
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构NOVARTIS PHARMACEUTICALS CORP
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
017543000APOther 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
017543030AP1997/04/10Labeling Revision
017543029AP1997/04/10Labeling Revision
017543028AP1996/03/05Manufacturing Change or Addition
017543027AP1994/11/28Control Supplement
017543026AP1997/04/10Labeling Revision
017543025AP1993/07/12Control Supplement
017543024AP1994/06/28Control Supplement
017543022AP1990/03/27Manufacturing Change or Addition
017543021AP1997/04/10Labeling Revision
017543020AP1989/04/07Package Change
017543019AP1997/04/10Labeling Revision
017543018AP1997/04/10Labeling Revision
017543017AP1985/03/21Control Supplement
017543016AP1985/04/26Labeling Revision
017543015AP1983/11/04Control Supplement
017543014AP1983/06/16Labeling Revision
017543012AP1982/11/17Labeling Revision
017543011AP1982/11/08Labeling Revision
017543010AP1982/10/21Package Change
017543009AP1983/01/12Labeling Revision
017543008AP1981/08/03Package Change
017543007AP1981/08/03Package Change
017543006AP1981/08/03Package Change
017543005AP1981/08/03Package Change
017543004AP1981/08/03Labeling Revision
017543002AP1982/09/30Formulation Revision
017543001AP1981/05/29General Efficacy (MarkIV)
017543000AP1980/12/01Approval