药品名称 | BACTRIM PEDIATRIC | 申请号 | 017560 | 产品号 | 002 | 活性成分 | SULFAMETHOXAZOLE; TRIMETHOPRIM | 市场状态 | 停止上市 | 剂型或给药途径 | SUSPENSION;ORAL | 规格 | 200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 治疗等效代码 | | 参比药物 | 否 | 批准日期 | Approved Prior to Jan 1, 1982 | 申请机构 | SUN PHARMACEUTICAL INDUSTRIES INC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 dosage form | 审评分类 | Standard review drug |
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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 |
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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 |
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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 | 无 |
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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 | 017560 | 043 | AP | 2001/11/09 | Control Supplement | 017560 | 039 | AP | 1990/06/15 | New or Modified Indication | 017560 | 036 | AP | 1987/06/04 | Control Supplement | 017560 | 035 | AP | 1996/03/06 | Labeling Revision | 017560 | 034 | AP | 1987/08/11 | Labeling Revision | 017560 | 033 | AP | 1985/06/10 | Control Supplement | 017560 | 032 | AP | 1985/02/20 | Control Supplement | 017560 | 031 | AP | 1984/06/12 | Control Supplement | 017560 | 030 | AP | 1984/11/23 | Labeling Revision | 017560 | 028 | AP | 1982/06/15 | Control Supplement | 017560 | 027 | AP | 1982/03/29 | Package Change | 017560 | 026 | AP | 1981/10/09 | Control Supplement | 017560 | 025 | AP | 1981/04/23 | Control Supplement | 017560 | 024 | AP | 1981/01/09 | Control Supplement | 017560 | 023 | AP | 1981/01/09 | Control Supplement | 017560 | 022 | AP | 1981/01/09 | Control Supplement | 017560 | 021 | AP | 1980/10/28 | Control Supplement | 017560 | 020 | AP | 1980/12/10 | Expiration Date Change | 017560 | 019 | AP | 1980/10/31 | Labeling Revision | 017560 | 018 | AP | 1982/02/23 | General Efficacy (MarkIV) | 017560 | 017 | AP | 1979/12/17 | Package Change | 017560 | 016 | AP | 1979/12/17 | Labeling Revision | 017560 | 015 | AP | 1979/12/07 | Control Supplement | 017560 | 014 | AP | 1979/12/17 | Labeling Revision | 017560 | 013 | AP | 1979/12/07 | Manufacturing Change or Addition | 017560 | 012 | AP | 1979/07/26 | Labeling Revision | 017560 | 011 | AP | 1979/02/27 | Formulation Revision | 017560 | 010 | AP | 1977/11/14 | Labeling Revision | 017560 | 009 | AP | 1977/04/21 | Package Change | 017560 | 008 | AP | 1978/10/11 | Labeling Revision | 017560 | 007 | AP | 1978/03/01 | Labeling Revision | 017560 | 006 | AP | 1976/08/23 | Packaging Addition | 017560 | 005 | AP | 1976/12/27 | Control Supplement | 017560 | 003 | AP | 1976/06/01 | Labeling Revision | 017560 | 000 | AP | 1975/04/15 | Approval |
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