| 药品名称 | ORTHO-NOVUM 10/11-28 | | 申请号 | 018354 | 产品号 | 002 | | 活性成分 | ETHINYL ESTRADIOL; NORETHINDRONE | 市场状态 | 停止上市 | | 剂型或给药途径 | TABLET;ORAL-28 | 规格 | 0.035MG;0.5MG;1MG | | 治疗等效代码 | | 参比药物 | 否 | | 批准日期 | 1982/01/11 | 申请机构 | ORTHO MCNEIL JANSSEN PHARMACEUTICALS INC
| | 化学类型 | New dosage form | 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 | | 018354 | 043 | AP | 2002/06/03 | Control Supplement | | 018354 | 042 | AP | 2002/02/21 | Manufacturing Change or Addition | | 018354 | 041 | AP | 2001/07/09 | Control Supplement | | 018354 | 039 | AP | 2000/01/05 | Package Change | | 018354 | 038 | AP | 2000/01/21 | Labeling Revision | | 018354 | 037 | AP | 1999/08/27 | Labeling Revision | | 018354 | 036 | AP | 1998/04/28 | Manufacturing Change or Addition | | 018354 | 035 | AP | 1998/04/13 | Manufacturing Change or Addition | | 018354 | 034 | AP | 1999/08/27 | Labeling Revision | | 018354 | 033 | AP | 1997/01/29 | Manufacturing Change or Addition | | 018354 | 032 | AP | 1997/02/24 | Control Supplement | | 018354 | 031 | AP | 1996/04/09 | Control Supplement | | 018354 | 030 | AP | 1996/05/10 | Control Supplement | | 018354 | 029 | AP | 1995/11/30 | Manufacturing Change or Addition | | 018354 | 028 | AP | 1995/09/07 | Control Supplement | | 018354 | 027 | AP | 1995/02/16 | Control Supplement | | 018354 | 026 | AP | 1994/07/06 | Labeling Revision | | 018354 | 025 | AP | 1993/11/04 | Manufacturing Change or Addition | | 018354 | 024 | AP | 1993/05/18 | Control Supplement | | 018354 | 023 | AP | 1994/03/07 | Formulation Revision | | 018354 | 021 | AP | 1991/03/18 | Control Supplement | | 018354 | 020 | AP | 1991/09/16 | Labeling Revision | | 018354 | 019 | AP | 1990/01/18 | Control Supplement | | 018354 | 017 | AP | 1989/10/23 | Labeling Revision | | 018354 | 016 | AP | 1989/07/19 | Labeling Revision | | 018354 | 015 | AP | 1988/10/28 | Control Supplement | | 018354 | 014 | AP | 1988/06/08 | Manufacturing Change or Addition | | 018354 | 013 | AP | 1988/09/09 | Labeling Revision | | 018354 | 012 | AP | 1987/02/26 | Labeling Revision | | 018354 | 011 | AP | 1987/11/23 | Control Supplement | | 018354 | 009 | AP | 1985/10/21 | Labeling Revision | | 018354 | 008 | AP | 1985/04/05 | Labeling Revision | | 018354 | 007 | AP | 1984/06/21 | Labeling Revision | | 018354 | 006 | AP | 1984/01/30 | Labeling Revision | | 018354 | 005 | AP | 1983/09/29 | Labeling Revision | | 018354 | 003 | AP | 1983/06/15 | Labeling Revision | | 018354 | 002 | AP | 1983/06/09 | Control Supplement | | 018354 | 000 | AP | 1982/01/11 | Approval |
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