药品名称SEPTRA
申请号018452产品号001
活性成分SULFAMETHOXAZOLE; TRIMETHOPRIM市场状态停止上市
剂型或给药途径INJECTABLE;INJECTION规格80MG/ML;16MG/ML
治疗等效代码参比药物
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
018452025APLabel2008/03/13下载
018452025APLetter2008/03/13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
018452025AP2008/03/11Labeling Revision
018452024AP1997/02/14Labeling Revision
018452023AP1996/07/12Manufacturing Change or Addition
018452022AP1997/03/19Labeling Revision
018452021AP1996/09/11Labeling Revision
018452020AP1993/03/16Manufacturing Change or Addition
018452019AP1993/02/22Manufacturing Change or Addition
018452018AP1992/08/21Labeling Revision
018452017AP1992/12/01Control Supplement
018452016AP1997/03/19Labeling Revision
018452015AP1990/07/09Package Change
018452014AP1989/04/06Control Supplement
018452013AP1997/03/19Labeling Revision
018452012AP1997/03/19Labeling Revision
018452010AP1987/11/02Manufacturing Change or Addition
018452009AP1987/04/22Control Supplement
018452008AP1990/11/09Labeling Revision
018452007AP1987/08/11Labeling Revision
018452006AP1986/03/14Manufacturing Change or Addition
018452005AP1984/06/01Labeling Revision
018452004AP1983/05/16Package Change
018452002AP1984/11/01Practioner Draft Labeling
018452001AP1982/09/16Control Supplement
018452000AP1981/06/23Approval