药品名称 | BREVICON 28-DAY | 申请号 | 017743 | 产品号 | 001 | 活性成分 | ETHINYL ESTRADIOL; NORETHINDRONE | 市场状态 | 处方药 | 剂型或给药途径 | TABLET;ORAL-28 | 规格 | 0.035MG;0.5MG | 治疗等效代码 | AB | 参比药物 | 否 | 批准日期 | Approved Prior to Jan 1, 1982 | 申请机构 | ALLERGAN SALES LLC
| 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 | 017743 | 075 | AP | 2001/08/15 | Manufacturing Change or Addition | 017743 | 074 | AP | 2000/01/24 | Labeling Revision | 017743 | 073 | AP | 2000/02/14 | Manufacturing Change or Addition | 017743 | 072 | AP | 1999/02/04 | Control Supplement | 017743 | 071 | AP | 1997/07/30 | Manufacturing Change or Addition | 017743 | 070 | AP | 1994/12/13 | Labeling Revision | 017743 | 069 | AP | 1995/08/30 | Labeling Revision | 017743 | 068 | AP | 1992/07/31 | Manufacturing Change or Addition | 017743 | 067 | AP | 1994/02/04 | Labeling Revision | 017743 | 066 | AP | 1990/09/19 | Control Supplement | 017743 | 065 | AP | 1989/10/20 | Control Supplement | 017743 | 064 | AP | 1989/02/22 | Control Supplement | 017743 | 063 | AP | 1990/11/02 | Labeling Revision | 017743 | 061 | AP | 1986/07/17 | Labeling Revision | 017743 | 060 | AP | 1985/10/25 | Labeling Revision | 017743 | 059 | AP | 1985/04/16 | Labeling Revision | 017743 | 057 | AP | 1984/11/13 | Manufacturing Change or Addition | 017743 | 056 | AP | 1984/07/30 | Labeling Revision | 017743 | 055 | AP | 1984/06/12 | Labeling Revision | 017743 | 053 | AP | 1984/09/27 | Control Supplement | 017743 | 052 | AP | 1984/05/07 | Labeling Revision | 017743 | 051 | AP | 1983/07/26 | Control Supplement | 017743 | 050 | AP | 1983/07/19 | Control Supplement | 017743 | 049 | AP | 1983/07/19 | Control Supplement | 017743 | 048 | AP | 1984/03/06 | Labeling Revision | 017743 | 047 | AP | 1983/07/26 | Control Supplement | 017743 | 046 | AP | 1983/06/13 | Control Supplement | 017743 | 045 | AP | 1987/10/26 | Formulation Revision | 017743 | 044 | AP | 1984/05/16 | Control Supplement | 017743 | 041 | AP | 1982/07/29 | Control Supplement | 017743 | 038 | AP | 1982/01/11 | Control Supplement | 017743 | 034 | AP | 1980/12/18 | Control Supplement | 017743 | 033 | AP | 1980/12/18 | Control Supplement | 017743 | 031 | AP | 1980/06/23 | Package Change | 017743 | 030 | AP | 1979/07/18 | Manufacturing Change or Addition | 017743 | 027 | AP | 1979/07/18 | Control Supplement | 017743 | 022 | AP | 1978/11/06 | Control Supplement | 017743 | 021 | AP | 1978/11/06 | Control Supplement | 017743 | 019 | AP | 1978/05/26 | Control Supplement | 017743 | 008 | AP | 1977/06/14 | Labeling Revision | 017743 | 007 | AP | 1977/06/14 | Labeling Revision | 017743 | 004 | AP | 1977/07/01 | Distributor | 017743 | 000 | AP | 1976/03/29 | Approval |
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