药品名称 | ANTURANE | 申请号 | 011556 | 产品号 | 003 | 活性成分 | SULFINPYRAZONE | 市场状态 | 停止上市 | 剂型或给药途径 | TABLET;ORAL | 规格 | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 治疗等效代码 | | 参比药物 | 否 | 批准日期 | Approved Prior to Jan 1, 1982 | 申请机构 | NOVARTIS PHARMACEUTICALS CORP
| 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 | 011556 | 053 | AP | Letter | 2002/08/26 | 下载![](pdf.jpg) |
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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 | 011556 | 054 | AP | 1999/04/22 | Package Change | 011556 | 053 | AP | 2002/08/26 | Labeling Revision | 011556 | 052 | AP | 1998/09/12 | Control Supplement | 011556 | 051 | AP | 1993/01/04 | Control Supplement | 011556 | 050 | AP | 1992/10/20 | Formulation Revision | 011556 | 049 | AP | 1990/06/13 | Formulation Revision | 011556 | 048 | AP | 1987/07/08 | Formulation Revision | 011556 | 047 | AP | 1986/09/02 | Manufacturing Change or Addition | 011556 | 046 | AP | 1987/03/17 | Manufacturing Change or Addition | 011556 | 045 | AP | 1986/04/07 | Labeling Revision | 011556 | 044 | AP | 1986/12/08 | Manufacturing Change or Addition | 011556 | 043 | AP | 1985/09/30 | Control Supplement | 011556 | 042 | AP | 1985/02/27 | Control Supplement | 011556 | 041 | AP | 1985/10/08 | Control Supplement | 011556 | 040 | AP | 1983/04/09 | Package Change | 011556 | 038 | AP | 1984/06/12 | Labeling Revision | 011556 | 037 | AP | 1980/02/26 | Manufacturing Change or Addition | 011556 | 036 | AP | 1980/10/27 | Control Supplement | 011556 | 035 | AP | 1979/09/07 | Manufacturing Change or Addition | 011556 | 034 | AP | 1979/07/20 | Manufacturing Change or Addition | 011556 | 033 | AP | 1979/07/20 | Manufacturing Change or Addition | 011556 | 032 | AP | 1978/08/29 | Expiration Date Change | 011556 | 031 | AP | 1978/09/26 | Control Supplement | 011556 | 000 | AP | 1959/05/13 | Approval |
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