药品名称 | NORINYL 1+50 28-DAY | 申请号 | 016659 | 产品号 | 001 | 活性成分 | MESTRANOL; NORETHINDRONE | 市场状态 | 处方药 | 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 | 是 | 批准日期 | Approved Prior to Jan 1, 1982 | 申请机构 | ACTAVIS LABORATORIES UT INC
| 化学类型 | New dosage form | 审评分类 | Priority 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 | 016659 | 137 | AP | 2013/10/30 | Manufacturing Change or Addition | 016659 | 136 | AP | 2013/12/03 | Manufacturing Change or Addition | 016659 | 125 | AP | 2000/01/24 | Labeling Revision | 016659 | 124 | AP | 1999/05/14 | Manufacturing Change or Addition | 016659 | 123 | AP | 1999/02/04 | Control Supplement | 016659 | 122 | AP | 1997/07/30 | Manufacturing Change or Addition | 016659 | 121 | AP | 1994/12/13 | Labeling Revision | 016659 | 120 | AP | 1995/08/30 | Labeling Revision | 016659 | 119 | AP | 1992/07/31 | Manufacturing Change or Addition | 016659 | 118 | AP | 1994/02/04 | Labeling Revision | 016659 | 117 | AP | 1991/10/09 | Control Supplement | 016659 | 116 | AP | 1990/09/19 | Control Supplement | 016659 | 115 | AP | 1990/08/15 | Control Supplement | 016659 | 113 | AP | 1990/11/02 | Labeling Revision | 016659 | 110 | AP | 1986/07/17 | Labeling Revision | 016659 | 109 | AP | 1985/10/25 | Labeling Revision | 016659 | 108 | AP | 1985/04/16 | Labeling Revision | 016659 | 106 | AP | 1984/11/13 | Manufacturing Change or Addition | 016659 | 105 | AP | 1984/07/30 | Labeling Revision | 016659 | 104 | AP | 1984/06/12 | Labeling Revision | 016659 | 102 | AP | 1984/09/27 | Control Supplement | 016659 | 101 | AP | 1984/05/07 | Labeling Revision | 016659 | 100 | AP | 1983/07/26 | Control Supplement | 016659 | 099 | AP | 1983/07/19 | Control Supplement | 016659 | 098 | AP | 1983/07/19 | Control Supplement | 016659 | 097 | AP | 1984/03/06 | Labeling Revision | 016659 | 096 | AP | 1983/07/26 | Control Supplement | 016659 | 095 | AP | 1983/06/13 | Control Supplement | 016659 | 092 | AP | 1982/07/29 | Control Supplement | 016659 | 089 | AP | 1982/09/07 | Control Supplement | 016659 | 087 | AP | 1982/01/11 | Control Supplement | 016659 | 082 | AP | 1979/07/18 | Manufacturing Change or Addition | 016659 | 079 | AP | 1979/07/18 | Control Supplement | 016659 | 075 | AP | 1978/11/06 | Control Supplement | 016659 | 074 | AP | 1978/11/06 | Control Supplement | 016659 | 073 | AP | 1978/05/26 | Control Supplement | 016659 | 061 | AP | 1977/06/14 | Labeling Revision | 016659 | 060 | AP | 1977/06/14 | Labeling Revision | 016659 | 059 | AP | 1977/06/14 | Labeling Revision | 016659 | 055 | AP | 1977/07/01 | Distributor | 016659 | 054 | AP | 1977/07/01 | Distributor | 016659 | 052 | AP | 1976/09/29 | Control Supplement | 016659 | 048 | AP | 1975/05/16 | Labeling Revision | 016659 | 046 | AP | 1975/05/16 | Control Supplement | 016659 | 043 | AP | 1975/05/16 | Control Supplement | 016659 | 039 | AP | 1975/05/16 | Control Supplement | 016659 | 037 | AP | 1975/05/16 | Labeling Revision | 016659 | 000 | AP | 1967/11/17 | Approval |
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