药品名称 | NORINYL 1+80 21-DAY | 申请号 | 016724 | 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-21 | 规格 | 0.08MG;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 | GD SEARLE LLC
| 化学类型 | New formulation or new manufacturer | 审评分类 | Standard review drug |
|
|
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 |
|
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 |
|
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 |
|
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 | 016724 | 108 | AP | 1986/07/17 | Labeling Revision | 016724 | 107 | AP | 1985/10/25 | Labeling Revision | 016724 | 106 | AP | 1985/04/16 | Labeling Revision | 016724 | 104 | AP | 1984/11/13 | Manufacturing Change or Addition | 016724 | 103 | AP | 1984/07/30 | Labeling Revision | 016724 | 101 | AP | 1984/09/27 | Control Supplement | 016724 | 100 | AP | 1984/05/07 | Labeling Revision | 016724 | 099 | AP | 1983/07/26 | Control Supplement | 016724 | 098 | AP | 1983/07/19 | Control Supplement | 016724 | 097 | AP | 1983/07/19 | Control Supplement | 016724 | 096 | AP | 1984/03/06 | Labeling Revision | 016724 | 095 | AP | 1983/07/26 | Control Supplement | 016724 | 094 | AP | 1983/06/13 | Control Supplement | 016724 | 090 | AP | 1982/07/29 | Control Supplement | 016724 | 086 | AP | 1982/01/11 | Control Supplement | 016724 | 081 | AP | 1980/04/17 | Formulation Revision | 016724 | 080 | AP | 1979/07/18 | Manufacturing Change or Addition | 016724 | 077 | AP | 1979/07/18 | Control Supplement | 016724 | 071 | AP | 1978/11/06 | Control Supplement | 016724 | 068 | AP | 1978/11/06 | Control Supplement | 016724 | 067 | AP | 1978/05/26 | Control Supplement | 016724 | 058 | AP | 1977/11/22 | Labeling Revision | 016724 | 057 | AP | 1977/11/22 | Labeling Revision | 016724 | 055 | AP | 1977/06/14 | Labeling Revision | 016724 | 054 | AP | 1977/06/14 | Labeling Revision | 016724 | 053 | AP | 1977/06/14 | Labeling Revision | 016724 | 052 | AP | 1977/06/14 | Labeling Revision | 016724 | 048 | AP | 1977/07/01 | Distributor | 016724 | 047 | AP | 1977/07/01 | Distributor | 016724 | 045 | AP | 1976/09/29 | Control Supplement | 016724 | 042 | AP | 1975/05/16 | Labeling Revision | 016724 | 040 | AP | 1975/05/16 | Control Supplement | 016724 | 037 | AP | 1975/05/16 | Control Supplement | 016724 | 034 | AP | 1975/05/16 | Control Supplement | 016724 | 033 | AP | 1975/05/16 | Control Supplement | 016724 | 030 | AP | 1975/05/16 | Control Supplement | 016724 | 029 | AP | 1975/05/16 | Labeling Revision | 016724 | 000 | AP | 1968/11/06 | Approval |
|