药品名称 | CORDRAN | 申请号 | 012806 | 产品号 | 004 | 活性成分 | FLURANDRENOLIDE | 市场状态 | 停止上市 | 剂型或给药途径 | OINTMENT;TOPICAL | 规格 | 0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 治疗等效代码 | | 参比药物 | 否 | 批准日期 | Approved Prior to Jan 1, 1982 | 申请机构 | AQUA PHARMACEUTICALS
| 化学类型 | New molecular entity (NME) | 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 | 012806 | 037 | AP | Label | 2013/07/30 | 下载 | 012806 | 036 | AP | Letter | 2013/06/14 | 下载 | 012806 | 028 | AP | Letter | 2002/07/17 | 下载 |
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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 | 012806 | 037 | AP | 2013/07/23 | Manufacturing Change or Addition | 012806 | 036 | AP | 2013/06/12 | Manufacturing Change or Addition | 012806 | 035 | AP | 2012/12/14 | Manufacturing Change or Addition | 012806 | 028 | AP | 2002/07/17 | Manufacturing Change or Addition | 012806 | 027 | AP | 1998/11/06 | Manufacturing Change or Addition | 012806 | 026 | AP | 1991/08/30 | Package Change | 012806 | 025 | AP | 1990/10/02 | Package Change | 012806 | 024 | AP | 1987/12/18 | Control Supplement | 012806 | 023 | AP | 1987/06/03 | Manufacturing Change or Addition | 012806 | 022 | AP | 1986/11/14 | Labeling Revision | 012806 | 021 | AP | 1982/10/08 | Practioner Draft Labeling | 012806 | 020 | AP | 1980/08/12 | Labeling Revision | 012806 | 019 | AP | 1979/11/26 | Control Supplement | 012806 | 017 | AP | 1978/06/30 | Labeling Revision | 012806 | 016 | AP | 1978/07/24 | Labeling Revision | 012806 | 015 | AP | 1977/12/14 | Expiration Date Change | 012806 | 014 | AP | 1977/02/23 | Labeling Revision | 012806 | 013 | AP | 1977/11/11 | Control Supplement | 012806 | 000 | AP | 1965/10/18 | Approval |
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