药品名称 | SYNALAR-HP | 申请号 | 016161 | 产品号 | 002 | 活性成分 | FLUOCINOLONE ACETONIDE | 市场状态 | 停止上市 | 剂型或给药途径 | CREAM;TOPICAL | 规格 | 0.2% | 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 | MEDIMETRIKS PHARMACEUTICALS 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 | 016161 | 043 | AP | 1992/11/13 | Control Supplement | 016161 | 042 | AP | 1994/10/24 | Labeling Revision | 016161 | 041 | AP | 1992/04/24 | Control Supplement | 016161 | 040 | AP | 1990/02/13 | Control Supplement | 016161 | 039 | AP | 1989/02/10 | Control Supplement | 016161 | 038 | AP | 1985/07/24 | Control Supplement | 016161 | 037 | AP | 1984/08/29 | Manufacturing Change or Addition | 016161 | 036 | AP | 1983/09/07 | Manufacturing Change or Addition | 016161 | 033 | AP | 1982/11/19 | Manufacturing Change or Addition | 016161 | 032 | AP | 1981/11/20 | Manufacturing Change or Addition | 016161 | 031 | AP | 1981/11/10 | Control Supplement | 016161 | 030 | AP | 1981/03/18 | Labeling Revision | 016161 | 029 | AP | 1981/01/19 | Package Change | 016161 | 028 | AP | 1981/01/19 | Package Change | 016161 | 027 | AP | 1981/01/19 | Package Change | 016161 | 026 | AP | 1981/01/19 | Package Change | 016161 | 025 | AP | 1979/10/23 | Manufacturing Change or Addition | 016161 | 024 | AP | 1979/08/13 | Manufacturing Change or Addition | 016161 | 023 | AP | 1978/11/28 | Control Supplement | 016161 | 022 | AP | 1978/09/12 | Labeling Revision | 016161 | 021 | AP | 1978/06/30 | Control Supplement | 016161 | 020 | AP | 1977/12/14 | Control Supplement | 016161 | 019 | AP | 1977/05/11 | Control Supplement | 016161 | 018 | AP | 1977/05/11 | Control Supplement | 016161 | 017 | AP | 1977/06/04 | Manufacturing Change or Addition | 016161 | 016 | AP | 1977/01/04 | Labeling Revision | 016161 | 000 | AP | 1967/07/25 | Approval |
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