药品名称 | MESANTOIN | 申请号 | 006008 | 产品号 | 001 | 活性成分 | MEPHENYTOIN | 市场状态 | 停止上市 | 剂型或给药途径 | TABLET;ORAL | 规格 | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 治疗等效代码 | | 参比药物 | 否 | 批准日期 | Approved Prior to Jan 1, 1982 | 申请机构 | NOVARTIS PHARMACEUTICALS CORP
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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 | 006008 | 049 | AP | 2001/04/02 | Manufacturing Change or Addition | 006008 | 048 | AP | 1999/04/23 | Package Change | 006008 | 046 | AP | 1997/07/15 | Control Supplement | 006008 | 045 | AP | 1996/02/21 | Control Supplement | 006008 | 044 | AP | 1995/02/15 | Control Supplement | 006008 | 043 | AP | 1995/08/14 | Control Supplement | 006008 | 042 | AP | 1994/12/14 | Labeling Revision | 006008 | 041 | AP | 1994/12/14 | Labeling Revision | 006008 | 040 | AP | 1994/11/23 | Package Change | 006008 | 039 | AP | 1996/07/23 | Formulation Revision | 006008 | 038 | AP | 1994/07/01 | Control Supplement | 006008 | 035 | AP | 1987/11/10 | Labeling Revision | 006008 | 034 | AP | 1986/08/27 | Control Supplement | 006008 | 033 | AP | 1984/12/05 | Manufacturing Change or Addition | 006008 | 032 | AP | 1986/08/27 | Control Supplement | 006008 | 031 | AP | 1983/08/08 | Control Supplement | 006008 | 030 | AP | 1981/07/20 | Manufacturing Change or Addition | 006008 | 027 | AP | 1981/03/06 | Package Change | 006008 | 026 | AP | 1980/07/24 | Labeling Revision | 006008 | 025 | AP | 1979/06/14 | Package Change | 006008 | 024 | AP | 1978/09/28 | Package Change | 006008 | 023 | AP | 1978/02/13 | Package Change | 006008 | 022 | AP | 1977/02/18 | Package Change | 006008 | 021 | AP | 1976/07/20 | Package Change | 006008 | 020 | AP | 1976/07/23 | Package Change | 006008 | 019 | AP | 1976/05/04 | Package Change | 006008 | 018 | AP | 1976/05/04 | Control Supplement | 006008 | 017 | AP | 1975/07/01 | Control Supplement | 006008 | 015 | AP | 1975/11/10 | Labeling Revision | 006008 | 014 | AP | 1974/09/20 | Control Supplement | 006008 | 011 | AP | 1974/08/29 | Control Supplement | 006008 | 000 | AP | 1946/10/23 | Approval |
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