药品名称BRETHINE
申请号017849产品号002
活性成分TERBUTALINE SULFATE市场状态停止上市
剂型或给药途径TABLET;ORAL规格5MG
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构LEHIGH VALLEY TECHNOLOGIES INC
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
017849039APLetter2003/12/23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
017849040AP2011/04/08Labeling Revision
017849039AP2003/12/19Labeling Revision
017849038AP2002/03/04Manufacturing Change or Addition
017849037AP2002/05/28Manufacturing Change or Addition
017849036AP1999/04/23Package Change
017849034AP1999/02/08Manufacturing Change or Addition
017849033AP1997/09/09Control Supplement
017849032AP1999/02/02Labeling Revision
017849031AP1997/02/25Control Supplement
017849030AP1997/07/07Manufacturing Change or Addition
017849029AP1996/02/23Control Supplement
017849028AP1995/12/18Package Change
017849027AP1995/11/14Control Supplement
017849026AP1995/03/24Control Supplement
017849025AP1992/07/16Control Supplement
017849024AP1993/02/09Manufacturing Change or Addition
017849021AP1986/01/31Control Supplement
017849020AP1984/05/16Control Supplement
017849018AP1984/05/16Control Supplement
017849017AP1984/05/16Package Change
017849016AP1982/03/22Control Supplement
017849015AP1981/06/06Control Supplement
017849014AP1980/11/05Control Supplement
017849013AP1980/02/13Package Change
017849012AP1980/06/25Control Supplement
017849011AP1980/06/04Control Supplement
017849010AP1979/04/03Manufacturing Change or Addition
017849009AP1979/04/03Control Supplement
017849008AP1979/04/03Control Supplement
017849007AP1979/05/24Labeling Revision
017849006AP1979/01/03Expiration Date Change
017849005AP1979/01/03Package Change
017849003AP1977/03/08Control Supplement
017849002AP1977/03/08Control Supplement
017849001AP1977/03/08Control Supplement
017849000AP1976/05/17Approval