药品名称 | ORTHO-NOVUM 1/50 28 | 申请号 | 016709 | 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-28 | 规格 | 0.05MG;1MG | 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 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 | 016709 | 128 | AP | 2002/06/03 | Control Supplement | 016709 | 126 | AP | 2000/06/05 | Labeling Revision | 016709 | 125 | AP | 2000/01/05 | Package Change | 016709 | 124 | AP | 1998/04/28 | Manufacturing Change or Addition | 016709 | 123 | AP | 1998/07/10 | Labeling Revision | 016709 | 122 | AP | 1997/11/28 | Labeling Revision | 016709 | 121 | AP | 1997/01/29 | Control Supplement | 016709 | 120 | AP | 1996/04/09 | Control Supplement | 016709 | 118 | AP | 1995/11/30 | Manufacturing Change or Addition | 016709 | 117 | AP | 1995/09/07 | Control Supplement | 016709 | 116 | AP | 1994/12/07 | Control Supplement | 016709 | 115 | AP | 1994/07/06 | Labeling Revision | 016709 | 114 | AP | 1993/11/04 | Manufacturing Change or Addition | 016709 | 113 | AP | 1993/05/18 | Control Supplement | 016709 | 112 | AP | 1994/03/07 | Formulation Revision | 016709 | 110 | AP | 1991/03/18 | Control Supplement | 016709 | 109 | AP | 1991/09/16 | Labeling Revision | 016709 | 108 | AP | 1990/01/18 | Control Supplement | 016709 | 107 | AP | 1996/12/27 | Control Supplement | 016709 | 106 | AP | 1989/10/23 | Labeling Revision | 016709 | 105 | AP | 1989/07/19 | Labeling Revision | 016709 | 104 | AP | 1988/10/28 | Control Supplement | 016709 | 103 | AP | 1988/06/08 | Manufacturing Change or Addition | 016709 | 102 | AP | 1988/09/09 | Labeling Revision | 016709 | 101 | AP | 1987/02/26 | Labeling Revision | 016709 | 100 | AP | 1987/11/23 | Control Supplement | 016709 | 098 | AP | 1985/10/21 | Labeling Revision | 016709 | 097 | AP | 1985/04/05 | Labeling Revision | 016709 | 096 | AP | 1984/06/21 | Labeling Revision | 016709 | 095 | AP | 1984/01/30 | Labeling Revision | 016709 | 094 | AP | 1983/09/29 | Labeling Revision | 016709 | 084 | AP | 1979/11/08 | Control Supplement | 016709 | 081 | AP | 1979/11/13 | Labeling Revision | 016709 | 080 | AP | 1979/10/19 | Package Change | 016709 | 077 | AP | 1978/07/25 | Control Supplement | 016709 | 076 | AP | 1978/06/26 | Labeling Revision | 016709 | 066 | AP | 1978/02/28 | Control Supplement | 016709 | 065 | AP | 1978/02/28 | Control Supplement | 016709 | 064 | AP | 1978/02/28 | Control Supplement | 016709 | 063 | AP | 1978/04/17 | Control Supplement | 016709 | 060 | AP | 1978/05/25 | Control Supplement | 016709 | 056 | AP | 1978/03/19 | Control Supplement | 016709 | 055 | AP | 1978/01/18 | Package Change | 016709 | 054 | AP | 1978/01/18 | Labeling Revision | 016709 | 053 | AP | 1978/07/25 | Control Supplement | 016709 | 052 | AP | 1977/07/01 | Labeling Revision | 016709 | 049 | AP | 1979/04/10 | Labeling Revision | 016709 | 038 | AP | 1976/08/09 | Control Supplement | 016709 | 034 | AP | 1976/08/09 | Control Supplement | 016709 | 032 | AP | 1975/08/07 | Control Supplement | 016709 | 031 | AP | 1975/08/07 | Control Supplement | 016709 | 030 | AP | 1975/08/07 | Control Supplement | 016709 | 029 | AP | 1975/08/07 | Control Supplement | 016709 | 028 | AP | 1975/08/07 | Control Supplement | 016709 | 027 | AP | 1975/08/07 | Control Supplement | 016709 | 026 | AP | 1975/05/21 | Control Supplement | 016709 | 025 | AP | 1975/05/21 | Control Supplement | 016709 | 023 | AP | 1975/05/21 | Control Supplement | 016709 | 022 | AP | 1975/05/21 | Control Supplement | 016709 | 021 | AP | 1975/03/06 | Other Amendment | 016709 | 000 | AP | 1968/08/21 | Approval |
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