药品名称 | TOPICORT | 申请号 | 017856 | 产品号 | 001 | 活性成分 | DESOXIMETASONE | 市场状态 | 停止上市 | 剂型或给药途径 | CREAM;TOPICAL | 规格 | 0.25% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 治疗等效代码 | | 参比药物 | 否 | 批准日期 | Approved Prior to Jan 1, 1982 | 申请机构 | TARO PHARMACEUTICALS NORTH AMERICA INC
| 化学类型 | New molecular entity (NME) | 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 | 017856 | 024 | AP | Letter | 2004/04/29 | 下载 | 017856 | 024 | AP | Label | 2004/05/04 | 下载 |
|
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 | 017856 | 030 | AP | 1998/09/15 | Manufacturing Change or Addition | 017856 | 028 | AP | 1996/01/25 | Manufacturing Change or Addition | 017856 | 027 | AP | 1994/07/26 | Manufacturing Change or Addition | 017856 | 026 | AP | 1993/10/13 | Control Supplement | 017856 | 024 | AP | 2004/04/27 | Labeling Revision | 017856 | 022 | AP | 1988/11/08 | Control Supplement | 017856 | 020 | AP | 1988/02/19 | Manufacturing Change or Addition | 017856 | 019 | AP | 1986/09/25 | Control Supplement | 017856 | 018 | AP | 1985/11/01 | Control Supplement | 017856 | 016 | AP | 1983/11/07 | Control Supplement | 017856 | 015 | AP | 1982/06/08 | Package Change | 017856 | 013 | AP | 1981/08/20 | Expiration Date Change | 017856 | 012 | AP | 1981/08/20 | Manufacturing Change or Addition | 017856 | 011 | AP | 1981/08/20 | Control Supplement | 017856 | 010 | AP | 1982/07/06 | Practioner Draft Labeling | 017856 | 009 | AP | 1980/10/09 | Control Supplement | 017856 | 008 | AP | 1979/10/23 | Control Supplement | 017856 | 007 | AP | 1979/10/23 | Control Supplement | 017856 | 006 | AP | 1979/10/23 | Manufacturing Change or Addition | 017856 | 005 | AP | 1979/10/22 | Control Supplement | 017856 | 004 | AP | 1979/07/23 | Control Supplement | 017856 | 003 | AP | 1979/07/03 | Package Change | 017856 | 002 | AP | 1978/06/30 | Labeling Revision | 017856 | 001 | AP | 1977/10/21 | Package Change | 017856 | 000 | AP | 1977/02/28 | Approval |
|