药品名称 | NORINYL 1+50 21-DAY | 申请号 | 013625 | 产品号 | 002 | 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 | 0.05MG;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 | ACTAVIS LABORATORIES UT INC
| 化学类型 | New formulation or new manufacturer | 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 | 013625 | 181 | AP | 2000/01/24 | Labeling Revision | 013625 | 180 | AP | 1999/05/14 | Manufacturing Change or Addition | 013625 | 179 | AP | 1999/02/04 | Control Supplement | 013625 | 178 | AP | 1997/07/30 | Manufacturing Change or Addition | 013625 | 177 | AP | 1994/12/13 | Labeling Revision | 013625 | 176 | AP | 1995/08/30 | Labeling Revision | 013625 | 175 | AP | 1992/07/31 | Manufacturing Change or Addition | 013625 | 174 | AP | 1994/02/04 | Labeling Revision | 013625 | 173 | AP | 1991/10/09 | Control Supplement | 013625 | 172 | AP | 1990/09/19 | Control Supplement | 013625 | 171 | AP | 1990/08/06 | Control Supplement | 013625 | 169 | AP | 1990/11/02 | Labeling Revision | 013625 | 166 | AP | 1986/10/22 | Practioner Draft Labeling | 013625 | 165 | AP | 1986/07/17 | Labeling Revision | 013625 | 164 | AP | 1985/10/25 | Labeling Revision | 013625 | 163 | AP | 1985/10/25 | Labeling Revision | 013625 | 162 | AP | 1985/06/19 | Labeling Revision | 013625 | 161 | AP | 1985/04/16 | Labeling Revision | 013625 | 159 | AP | 1984/11/13 | Manufacturing Change or Addition | 013625 | 158 | AP | 1984/07/30 | Labeling Revision | 013625 | 157 | AP | 1984/06/12 | Labeling Revision | 013625 | 155 | AP | 1984/09/27 | Control Supplement | 013625 | 154 | AP | 1984/05/07 | Labeling Revision | 013625 | 145 | AP | 1982/07/29 | Control Supplement | 013625 | 133 | AP | 1979/07/18 | Manufacturing Change or Addition | 013625 | 130 | AP | 1979/07/18 | Control Supplement | 013625 | 129 | AP | 1979/07/18 | Control Supplement | 013625 | 128 | AP | 1979/07/18 | Control Supplement | 013625 | 127 | AP | 1978/11/06 | Control Supplement | 013625 | 126 | AP | 1978/11/06 | Control Supplement | 013625 | 125 | AP | 1978/05/26 | Control Supplement | 013625 | 104 | AP | 1977/11/22 | Labeling Revision | 013625 | 103 | AP | 1977/11/22 | Labeling Revision | 013625 | 100 | AP | 1977/06/14 | Labeling Revision | 013625 | 099 | AP | 1977/06/14 | Labeling Revision | 013625 | 098 | AP | 1977/06/14 | Labeling Revision | 013625 | 097 | AP | 1977/05/26 | Labeling Revision | 013625 | 096 | AP | 1977/05/26 | Labeling Revision | 013625 | 095 | AP | 1977/06/14 | Labeling Revision | 013625 | 092 | AP | 1977/06/14 | Labeling Revision | 013625 | 087 | AP | 1977/05/26 | Labeling Revision | 013625 | 086 | AP | 1977/05/26 | Labeling Revision | 013625 | 085 | AP | 1977/07/01 | Labeling Revision | 013625 | 082 | AP | 1975/05/16 | Labeling Revision | 013625 | 080 | AP | 1975/05/16 | Control Supplement | 013625 | 078 | AP | 1975/05/16 | Control Supplement | 013625 | 074 | AP | 1975/05/16 | Control Supplement | 013625 | 072 | AP | 1975/05/16 | Labeling Revision | 013625 | 053 | AP | 1983/07/26 | Control Supplement | 013625 | 052 | AP | 1983/07/19 | Control Supplement | 013625 | 051 | AP | 1983/07/19 | Control Supplement | 013625 | 050 | AP | 1984/03/06 | Labeling Revision | 013625 | 049 | AP | 1983/07/26 | Control Supplement | 013625 | 048 | AP | 1983/06/13 | Control Supplement | 013625 | 042 | AP | 1982/09/07 | Control Supplement | 013625 | 040 | AP | 1982/01/11 | Control Supplement | 013625 | 000 | AP | 1964/03/05 | Approval |
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