药品名称 | BACTRIM | 申请号 | 017377 | 产品号 | 001 | 活性成分 | SULFAMETHOXAZOLE; TRIMETHOPRIM | 市场状态 | 处方药 | 剂型或给药途径 | TABLET;ORAL | 规格 | 400MG;80MG | 治疗等效代码 | AB | 参比药物 | 否 | 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 | 无 | 历史专利信息 | 无 |
|
与本品相关的市场独占权保护信息 | 独占权代码 | 失效日期 | 无 | 历史市场独占权保护信息 | 无 |
|
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 | 017377 | 074 | AP | Label | 2014/07/17 | 下载 | 017377 | 074 | AP | Letter | 2014/07/17 | 下载 | 017377 | 073 | AP | Label | 2013/07/17 | 下载 | 017377 | 073 | AP | Letter | 2013/07/15 | 下载 | 017377 | 071 | AP | Letter | 2012/08/31 | 下载 | 017377 | 071 | AP | Label | 2012/08/31 | 下载 | 017377 | 068 | AP | Letter | 2013/07/15 | 下载 | 017377 | 068 | AP | Label | 2013/07/17 | 下载 | 017377 | 067 | AP | Letter | 2010/07/29 | 下载 | 017377 | 067 | AP | Label | 2010/07/31 | 下载 | 017377 | 066 | AP | Letter | 2010/07/02 | 下载 | 017377 | 063 | AP | Letter | 2007/06/07 | 下载 | 017377 | 063 | AP | Label | 2007/06/07 | 下载 | 017377 | 058 | AP | Letter | 2002/10/17 | 下载 | 017377 | 058 | AP | Label | 2002/10/17 | 下载 | 017377 | 057 | AP | Letter | 2003/02/12 | 下载 | 017377 | 057 | AP | Label | 2003/02/12 | 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 | 017377 | 078 | AP | 2016/04/18 | Manufacturing Change or Addition | 017377 | 077 | AP | 2015/11/27 | Manufacturing Change or Addition | 017377 | 076 | AP | 2015/04/13 | Manufacturing Change or Addition | 017377 | 075 | AP | 2015/04/07 | Manufacturing Change or Addition | 017377 | 074 | AP | 2014/07/16 | Labeling Revision | 017377 | 073 | AP | 2013/07/12 | Labeling Revision | 017377 | 071 | AP | 2012/08/29 | Labeling Revision | 017377 | 068 | AP | 2013/07/12 | Labeling Revision | 017377 | 067 | AP | 2010/07/27 | Labeling Revision | 017377 | 066 | AP | 2010/06/28 | Labeling Revision | 017377 | 063 | AP | 2007/06/05 | Labeling Revision | 017377 | 058 | AP | 2002/10/17 | Formulation Revision | 017377 | 057 | AP | 2003/02/12 | Labeling Revision | 017377 | 056 | AP | 1998/11/17 | Labeling Revision | 017377 | 055 | AP | 1994/04/18 | Package Change | 017377 | 053 | AP | 2000/07/03 | Labeling Revision | 017377 | 052 | AP | 1990/07/17 | Manufacturing Change or Addition | 017377 | 050 | AP | 2000/07/03 | Labeling Revision | 017377 | 049 | AP | 1987/05/11 | Control Supplement | 017377 | 048 | AP | 1987/05/11 | Control Supplement | 017377 | 047 | AP | 1996/03/06 | Labeling Revision | 017377 | 046 | AP | 1987/08/11 | Labeling Revision | 017377 | 045 | AP | 1985/03/19 | Package Change | 017377 | 044 | AP | 1984/06/12 | Control Supplement | 017377 | 043 | AP | 1984/11/23 | Labeling Revision | 017377 | 042 | AP | 1984/05/09 | Package Change | 017377 | 041 | AP | 1983/08/01 | Manufacturing Change or Addition | 017377 | 040 | AP | 1990/06/15 | New or Modified Indication | 017377 | 039 | AP | 1983/06/15 | Control Supplement | 017377 | 037 | AP | 1981/10/09 | Control Supplement | 017377 | 036 | AP | 1981/12/09 | Labeling Revision | 017377 | 035 | AP | 1981/04/23 | Control Supplement | 017377 | 034 | AP | 1981/04/01 | Control Supplement | 017377 | 033 | AP | 1980/10/31 | Labeling Revision | 017377 | 032 | AP | 1982/02/23 | General Efficacy (MarkIV) | 017377 | 031 | AP | 1980/03/06 | Control Supplement | 017377 | 030 | AP | 1979/12/17 | Labeling Revision | 017377 | 029 | AP | 1979/04/18 | Control Supplement | 017377 | 028 | AP | 1978/04/19 | Control Supplement | 017377 | 027 | AP | 1978/10/11 | Labeling Revision | 017377 | 026 | AP | 1978/04/18 | Labeling Revision | 017377 | 025 | AP | 1978/03/01 | Labeling Revision | 017377 | 024 | AP | 1978/01/12 | Control Supplement | 017377 | 023 | AP | 1979/07/26 | Labeling Revision | 017377 | 022 | AP | 1977/05/02 | Labeling Revision | 017377 | 021 | AP | 1977/01/19 | Labeling Revision | 017377 | 020 | AP | 1976/11/22 | Control Supplement | 017377 | 019 | AP | 1976/10/01 | Control Supplement | 017377 | 018 | AP | 1977/02/15 | Control Supplement | 017377 | 016 | AP | 1976/05/12 | Formulation Revision | 017377 | 013 | AP | 1976/02/12 | Control Supplement | 017377 | 012 | AP | 1975/07/03 | Control Supplement | 017377 | 011 | AP | 1975/04/14 | Control Supplement | 017377 | 010 | AP | 1974/12/05 | Labeling Revision | 017377 | 009 | AP | 1974/12/05 | Labeling Revision | 017377 | 006 | AP | 1975/01/22 | Control Supplement | 017377 | 004 | AP | 1974/06/12 | Supplement | 017377 | 000 | AP | 1973/07/30 | Approval |
|