药品名称 | ROBAXISAL | 申请号 | 012281 | 产品号 | 001 | 活性成分 | ASPIRIN; METHOCARBAMOL | 市场状态 | 停止上市 | 剂型或给药途径 | TABLET;ORAL | 规格 | 325MG;400MG | 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 | AH ROBINS CO
| 化学类型 | New combination | 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 | 012281 | 052 | AP | Letter | 2004/03/02 | 下载 | 012281 | 051 | AP | Letter | 2004/03/02 | 下载 | 012281 | 050 | AP | Letter | 2004/03/02 | 下载 |
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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 | 012281 | 052 | AP | 2004/02/10 | Labeling Revision | 012281 | 051 | AP | 2004/02/10 | Labeling Revision | 012281 | 050 | AP | 2004/02/10 | Labeling Revision | 012281 | 049 | AP | 1998/04/22 | Manufacturing Change or Addition | 012281 | 046 | AP | 1990/10/19 | Manufacturing Change or Addition | 012281 | 045 | AP | 1989/01/06 | Manufacturing Change or Addition | 012281 | 044 | AP | 1987/01/22 | Control Supplement | 012281 | 043 | AP | 1988/01/22 | Control Supplement | 012281 | 042 | AP | 1989/05/02 | Control Supplement | 012281 | 041 | AP | 1986/01/14 | Labeling Revision | 012281 | 040 | AP | 1984/06/08 | Expiration Date Change | 012281 | 038 | AP | 1985/08/06 | Control Supplement | 012281 | 037 | AP | 1983/05/02 | Control Supplement | 012281 | 035 | AP | 1983/04/07 | Package Change | 012281 | 033 | AP | 1982/03/26 | Expiration Date Change | 012281 | 032 | AP | 1981/12/22 | Manufacturing Change or Addition | 012281 | 031 | AP | 1981/12/22 | Control Supplement | 012281 | 030 | AP | 1981/12/22 | Control Supplement | 012281 | 028 | AP | 1982/01/26 | Package Change | 012281 | 027 | AP | 1981/10/22 | Control Supplement | 012281 | 026 | AP | 1981/05/20 | Package Change | 012281 | 024 | AP | 1981/01/16 | Package Change | 012281 | 023 | AP | 1981/04/16 | Formulation Revision | 012281 | 021 | AP | 1979/09/19 | Package Change | 012281 | 020 | AP | 1979/09/17 | Manufacturing Change or Addition | 012281 | 019 | AP | 1980/02/13 | Manufacturing Change or Addition | 012281 | 016 | AP | 1980/03/27 | Control Supplement | 012281 | 013 | AP | 1979/12/06 | Expiration Date Change | 012281 | 009 | AP | 1975/08/11 | Control Supplement | 012281 | 005 | AP | 1975/04/28 | Distributor | 012281 | 000 | AP | 1960/04/15 | Approval |
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