药品名称SEPTRA DS
申请号017376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MONARCH PHARMACEUTICALS INC
化学类型审评分类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
017376060APLetter2013/09/05下载
017376060APLabel2013/09/09下载
017376059APLabel2007/09/11下载
017376059APLetter2007/09/25下载
017376058APLabel2008/03/13下载
017376058APLetter2008/03/13下载
017376056APLetter2005/08/03下载
017376056APLabel2005/08/03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
017376060AP2013/08/30Labeling Revision
017376059AP2007/09/10Labeling Revision
017376058AP2008/03/11Labeling Revision
017376056AP2005/07/28Labeling Revision
017376055AP2000/10/04Package Change
017376054AP2000/01/31Manufacturing Change or Addition
017376053AP1997/02/12Labeling Revision
017376052AP1998/04/07Labeling Revision
017376051AP1997/03/19Labeling Revision
017376048AP1996/09/11Labeling Revision
017376047AP1994/01/07Labeling Revision
017376046AP1993/02/22Manufacturing Change or Addition
017376045AP1992/12/01Control Supplement
017376044AP1997/03/19Labeling Revision
017376042AP1997/03/19Labeling Revision
017376041AP1990/06/15New or Modified Indication
017376040AP1989/02/02Labeling Revision
017376039AP1990/11/09Labeling Revision
017376038AP1985/08/09Control Supplement
017376037AP1987/08/11Labeling Revision
017376036AP1985/01/16Manufacturing Change or Addition
017376035AP1985/02/20Manufacturing Change or Addition
017376033AP1983/03/25Package Change
017376032AP1982/12/07Package Change
017376031AP1984/11/01Practioner Draft Labeling
017376030AP1982/04/27Labeling Revision
017376029AP1981/11/03Control Supplement
017376028AP1981/10/09Package Change
017376027AP1981/01/09Package Change
017376026AP1980/10/31Labeling Revision
017376025AP1980/09/09Expiration Date Change
017376024AP1980/10/28Control Supplement
017376023AP1978/11/20Package Change
017376022AP1978/12/08Control Supplement
017376021AP1979/07/26General Efficacy (MarkIV)
017376020AP1977/07/05Package Change
017376019AP1977/04/21Package Change
017376017AP1978/10/11General Efficacy (MarkIV)
017376016AP1976/11/22Package Change
017376015AP1976/11/22Package Change
017376013AP1977/03/07Formulation Revision
017376012AP1976/12/27Labeling Revision
017376010AP1976/02/12Labeling Revision
017376008AP1974/11/25Control Supplement
017376006AP1975/05/15Control Supplement
017376005AP1974/10/08Labeling Revision
017376003AP1974/05/01Supplement
017376002AP1974/10/08Supplement
017376000AP1973/07/30Approval