药品名称BACTRIM DS
申请号017377产品号002
活性成分SULFAMETHOXAZOLE; TRIMETHOPRIM市场状态处方药
剂型或给药途径TABLET;ORAL规格800MG;160MG
治疗等效代码AB参比药物
批准日期Approved Prior to Jan 1, 1982申请机构SUN PHARMACEUTICAL INDUSTRIES 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
017377074APLabel2014/07/17下载
017377074APLetter2014/07/17下载
017377073APLabel2013/07/17下载
017377073APLetter2013/07/15下载
017377071APLetter2012/08/31下载
017377071APLabel2012/08/31下载
017377068APLetter2013/07/15下载
017377068APLabel2013/07/17下载
017377067APLetter2010/07/29下载
017377067APLabel2010/07/31下载
017377066APLetter2010/07/02下载
017377063APLetter2007/06/07下载
017377063APLabel2007/06/07下载
017377058APLetter2002/10/17下载
017377058APLabel2002/10/17下载
017377057APLetter2003/02/12下载
017377057APLabel2003/02/12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
017377078AP2016/04/18Manufacturing Change or Addition
017377077AP2015/11/27Manufacturing Change or Addition
017377076AP2015/04/13Manufacturing Change or Addition
017377075AP2015/04/07Manufacturing Change or Addition
017377074AP2014/07/16Labeling Revision
017377073AP2013/07/12Labeling Revision
017377071AP2012/08/29Labeling Revision
017377068AP2013/07/12Labeling Revision
017377067AP2010/07/27Labeling Revision
017377066AP2010/06/28Labeling Revision
017377063AP2007/06/05Labeling Revision
017377058AP2002/10/17Formulation Revision
017377057AP2003/02/12Labeling Revision
017377056AP1998/11/17Labeling Revision
017377055AP1994/04/18Package Change
017377053AP2000/07/03Labeling Revision
017377052AP1990/07/17Manufacturing Change or Addition
017377050AP2000/07/03Labeling Revision
017377049AP1987/05/11Control Supplement
017377048AP1987/05/11Control Supplement
017377047AP1996/03/06Labeling Revision
017377046AP1987/08/11Labeling Revision
017377045AP1985/03/19Package Change
017377044AP1984/06/12Control Supplement
017377043AP1984/11/23Labeling Revision
017377042AP1984/05/09Package Change
017377041AP1983/08/01Manufacturing Change or Addition
017377040AP1990/06/15New or Modified Indication
017377039AP1983/06/15Control Supplement
017377037AP1981/10/09Control Supplement
017377036AP1981/12/09Labeling Revision
017377035AP1981/04/23Control Supplement
017377034AP1981/04/01Control Supplement
017377033AP1980/10/31Labeling Revision
017377032AP1982/02/23General Efficacy (MarkIV)
017377031AP1980/03/06Control Supplement
017377030AP1979/12/17Labeling Revision
017377029AP1979/04/18Control Supplement
017377028AP1978/04/19Control Supplement
017377027AP1978/10/11Labeling Revision
017377026AP1978/04/18Labeling Revision
017377025AP1978/03/01Labeling Revision
017377024AP1978/01/12Control Supplement
017377023AP1979/07/26Labeling Revision
017377022AP1977/05/02Labeling Revision
017377021AP1977/01/19Labeling Revision
017377020AP1976/11/22Control Supplement
017377019AP1976/10/01Control Supplement
017377018AP1977/02/15Control Supplement
017377016AP1976/05/12Formulation Revision
017377013AP1976/02/12Control Supplement
017377012AP1975/07/03Control Supplement
017377011AP1975/04/14Control Supplement
017377010AP1974/12/05Labeling Revision
017377009AP1974/12/05Labeling Revision
017377006AP1975/01/22Control Supplement
017377004AP1974/06/12Supplement
017377000AP1973/07/30Approval