药品名称 | ORTHO-NOVUM 10-21 | 申请号 | 012728 | 产品号 | 001 | 活性成分 | MESTRANOL; NORETHINDRONE | 市场状态 | 停止上市 | 剂型或给药途径 | TABLET;ORAL-21 | 规格 | 0.06MG;10MG | 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 | ORTHO MCNEIL PHARMACEUTICAL INC
| 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 | 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 | 012728 | 190 | AP | 2000/01/05 | Package Change | 012728 | 189 | AP | 1998/04/28 | Manufacturing Change or Addition | 012728 | 188 | AP | 1998/07/10 | Labeling Revision | 012728 | 186 | AP | 1997/01/29 | Control Supplement | 012728 | 185 | AP | 1996/04/09 | Control Supplement | 012728 | 183 | AP | 1995/11/30 | Manufacturing Change or Addition | 012728 | 182 | AP | 1995/09/07 | Control Supplement | 012728 | 181 | AP | 1994/12/07 | Control Supplement | 012728 | 180 | AP | 1994/06/28 | Labeling Revision | 012728 | 179 | AP | 1993/11/04 | Manufacturing Change or Addition | 012728 | 178 | AP | 1993/05/18 | Control Supplement | 012728 | 177 | AP | 1994/03/07 | Formulation Revision | 012728 | 175 | AP | 1991/03/18 | Control Supplement | 012728 | 174 | AP | 1991/09/16 | Labeling Revision | 012728 | 173 | AP | 1996/12/27 | Control Supplement | 012728 | 172 | AP | 1989/10/23 | Labeling Revision | 012728 | 171 | AP | 1989/07/19 | Labeling Revision | 012728 | 170 | AP | 1988/10/28 | Control Supplement | 012728 | 169 | AP | 1988/06/08 | Manufacturing Change or Addition | 012728 | 166 | AP | 1988/09/09 | Labeling Revision | 012728 | 165 | AP | 1987/02/26 | Labeling Revision | 012728 | 164 | AP | 1987/11/23 | Control Supplement | 012728 | 162 | AP | 1985/10/21 | Labeling Revision | 012728 | 161 | AP | 1985/04/05 | Labeling Revision | 012728 | 160 | AP | 1984/06/21 | Labeling Revision | 012728 | 159 | AP | 1984/01/30 | Labeling Revision | 012728 | 158 | AP | 1983/09/29 | Labeling Revision | 012728 | 105 | AP | 1978/09/14 | Labeling Revision | 012728 | 087 | AP | 1978/03/29 | Other Amendment | 012728 | 086 | AP | 1978/07/25 | Control Supplement | 012728 | 085 | AP | 1977/10/20 | Labeling Revision | 012728 | 084 | AP | 1977/07/01 | Labeling Revision | 012728 | 073 | AP | 1976/08/06 | Control Supplement | 012728 | 072 | AP | 1976/08/06 | Control Supplement | 012728 | 064 | AP | 1975/08/07 | Control Supplement | 012728 | 063 | AP | 1975/08/07 | Control Supplement | 012728 | 062 | AP | 1975/08/07 | Control Supplement | 012728 | 061 | AP | 1975/08/07 | Control Supplement | 012728 | 060 | AP | 1975/08/07 | Control Supplement | 012728 | 059 | AP | 1975/08/07 | Control Supplement | 012728 | 056 | AP | 1975/05/21 | Other Amendment | 012728 | 055 | AP | 1975/05/21 | Control Supplement | 012728 | 052 | AP | 1975/05/21 | Control Supplement | 012728 | 051 | AP | 1975/05/21 | Control Supplement | 012728 | 050 | AP | 1975/03/03 | Other Amendment | 012728 | 000 | AP | 1962/05/21 | Approval |
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