药品名称COGENTIN
申请号009193产品号003
活性成分BENZTROPINE MESYLATE市场状态停止上市
剂型或给药途径TABLET;ORAL规格1MG
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构MERCK AND CO INC
化学类型New molecular entity (NME)审评分类Priority 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
009193037APLetter2001/05/22下载
009193000APLetter2003/04/16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
009193037AP2001/05/22Labeling Revision
009193036AP1996/04/15Manufacturing Change or Addition
009193035AP1994/06/01Manufacturing Change or Addition
009193034AP1996/09/26Labeling Revision
009193032AP1988/04/08Package Change
009193031AP1988/01/20Manufacturing Change or Addition
009193030AP1986/08/25Control Supplement
009193029AP1986/01/14Labeling Revision
009193028AP1984/09/13Package Change
009193027AP1984/08/15Package Change
009193026AP1982/09/03Manufacturing Change or Addition
009193025AP1982/09/03Manufacturing Change or Addition
009193023AP1981/06/02Package Change
009193022AP1981/05/14Control Supplement
009193021AP1979/10/05Labeling Revision
009193020AP1979/04/19Labeling Revision
009193018AP1980/05/01Control Supplement
009193017AP1977/03/01Package Change
009193016AP1977/05/05Labeling Revision
009193014AP1975/01/15Labeling Revision
009193010AP1974/07/01Other Amendment
009193000AP1954/03/05Approval