药品名称 | SANOREX | 申请号 | 017247 | 产品号 | 001 | 活性成分 | MAZINDOL | 市场状态 | 停止上市 | 剂型或给药途径 | TABLET;ORAL | 规格 | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 治疗等效代码 | | 参比药物 | 否 | 批准日期 | Approved Prior to Jan 1, 1982 | 申请机构 | NOVARTIS PHARMACEUTICALS CORP
| 化学类型 | New molecular entity (NME) | 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 | 017247 | 042 | AP | 2001/09/17 | Manufacturing Change or Addition | 017247 | 041 | AP | 1996/02/27 | Manufacturing Change or Addition | 017247 | 040 | AP | 1995/10/17 | Control Supplement | 017247 | 038 | AP | 1994/09/19 | Control Supplement | 017247 | 037 | AP | 1995/03/13 | Control Supplement | 017247 | 036 | AP | 1992/11/27 | Labeling Revision | 017247 | 034 | AP | 1991/08/02 | Control Supplement | 017247 | 033 | AP | 1994/03/29 | Control Supplement | 017247 | 032 | AP | 1990/03/14 | Control Supplement | 017247 | 031 | AP | 1989/09/14 | Manufacturing Change or Addition | 017247 | 029 | AP | 1986/11/18 | Labeling Revision | 017247 | 027 | AP | 1981/06/25 | Manufacturing Change or Addition | 017247 | 026 | AP | 1981/01/21 | Package Change | 017247 | 025 | AP | 1982/01/06 | Labeling Revision | 017247 | 024 | AP | 1979/01/16 | Manufacturing Change or Addition | 017247 | 023 | AP | 1979/03/23 | Manufacturing Change or Addition | 017247 | 021 | AP | 1979/09/19 | Control Supplement | 017247 | 020 | AP | 1977/06/28 | Package Change | 017247 | 019 | AP | 1976/09/20 | Labeling Revision | 017247 | 018 | AP | 1976/05/10 | Package Change | 017247 | 017 | AP | 1976/03/31 | Package Change | 017247 | 014 | AP | 1975/10/06 | Control Supplement | 017247 | 012 | AP | 1974/11/15 | Control Supplement | 017247 | 011 | AP | 1974/11/15 | Labeling Revision | 017247 | 010 | AP | 1974/11/15 | Distributor | 017247 | 000 | AP | 1973/06/14 | Approval |
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