药品名称 | SOLU-MEDROL | 申请号 | 011856 | 产品号 | 004 | 活性成分 | METHYLPREDNISOLONE SODIUM SUCCINATE | 市场状态 | 处方药 | 剂型或给药途径 | INJECTABLE;INJECTION | 规格 | EQ 125MG BASE/VIAL | 治疗等效代码 | AP | 参比药物 | 是 | 批准日期 | Approved Prior to Jan 1, 1982 | 申请机构 | PHARMACIA AND UPJOHN CO
| 化学类型 | New active ingredient | 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 | 011856 | 126 | AP | Letter | 2016/09/09 | 下载 | 011856 | 126 | AP | Label | 2016/09/09 | 下载 | 011856 | 124 | AP | Label | 2016/09/09 | 下载 | 011856 | 124 | AP | Letter | 2016/09/09 | 下载 | 011856 | 123 | AP | Letter | 2014/07/07 | 下载 | 011856 | 123 | AP | Label | 2014/07/09 | 下载 | 011856 | 107 | AP | Letter | 2010/06/28 | 下载 | 011856 | 107 | AP | Label | 2010/07/01 | 下载 | 011856 | 104 | AP | Letter | 2011/10/25 | 下载 | 011856 | 104 | AP | Label | 2011/10/25 | 下载 | 011856 | 103 | AP | Label | 2011/10/25 | 下载 | 011856 | 103 | AP | Letter | 2011/10/25 | 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 | 011856 | 127 | AP | 2015/08/06 | Manufacturing Change or Addition | 011856 | 126 | AP | 2016/09/08 | Labeling Revision | 011856 | 124 | AP | 2016/09/08 | Labeling Revision | 011856 | 123 | AP | 2014/07/03 | Labeling Revision | 011856 | 122 | AP | 2014/06/09 | Manufacturing Change or Addition | 011856 | 121 | AP | 2014/07/22 | Manufacturing Change or Addition | 011856 | 119 | AP | 2014/03/28 | Manufacturing Change or Addition | 011856 | 116 | AP | 2014/04/04 | Manufacturing Change or Addition | 011856 | 107 | AP | 2010/06/24 | Labeling Revision | 011856 | 104 | AP | 2011/10/20 | Labeling Revision | 011856 | 103 | AP | 2011/10/20 | Manufacturing Change or Addition | 011856 | 094 | AP | 2002/10/21 | Control Supplement | 011856 | 093 | AP | 2000/04/03 | Manufacturing Change or Addition | 011856 | 092 | AP | 1999/03/16 | Control Supplement | 011856 | 091 | AP | 1998/02/26 | Control Supplement | 011856 | 087 | AP | 1994/09/15 | Control Supplement | 011856 | 084 | AP | 1994/04/06 | Package Change | 011856 | 081 | AP | 1994/03/25 | Package Change | 011856 | 078 | AP | 1993/11/05 | Control Supplement | 011856 | 077 | AP | 1991/09/04 | Labeling Revision | 011856 | 073 | AP | 1990/12/07 | Control Supplement | 011856 | 072 | AP | 1994/04/22 | Control Supplement | 011856 | 069 | AP | 1990/04/24 | Control Supplement | 011856 | 068 | AP | 1989/07/11 | Package Change | 011856 | 067 | AP | 1989/10/02 | Package Change | 011856 | 062 | AP | 1986/12/08 | Package Change | 011856 | 061 | AP | 1986/01/23 | Control Supplement | 011856 | 060 | AP | 1986/01/31 | Expiration Date Change | 011856 | 059 | AP | 1986/02/14 | Package Change | 011856 | 058 | AP | 1986/12/08 | Control Supplement | 011856 | 057 | AP | 1985/03/28 | Control Supplement | 011856 | 055 | AP | 1989/03/22 | Labeling Revision | 011856 | 054 | AP | 1983/05/03 | Labeling Revision | 011856 | 053 | AP | 1985/02/27 | Control Supplement | 011856 | 050 | AP | 1981/02/20 | Labeling Revision | 011856 | 049 | AP | 1981/10/16 | Package Change | 011856 | 047 | AP | 1980/09/30 | Package Change | 011856 | 046 | AP | 1980/04/28 | Package Change | 011856 | 044 | AP | 1981/08/11 | Package Change | 011856 | 043 | AP | 1979/11/13 | Labeling Revision | 011856 | 000 | AP | 1959/05/18 | Approval |
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