| 药品名称 | ROCALTROL | | 申请号 | 018044 | 产品号 | 002 | | 活性成分 | CALCITRIOL | 市场状态 | 处方药 | | 剂型或给药途径 | CAPSULE;ORAL | 规格 | 0.5MCG | | 治疗等效代码 | AB | 参比药物 | 是 | | 批准日期 | Approved Prior to Jan 1, 1982 | 申请机构 | VALIDUS PHARMACEUTICALS LLC
| | 化学类型 | New molecular entity (NME) | 审评分类 | Priority 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 | | 018044 | 038 | AP | Letter | 2010/03/03 | 下载 | | 018044 | 032 | AP | Letter | 2004/07/08 | 下载 | | 018044 | 028 | AP | Letter | 2002/02/01 | 下载 | | 018044 | 025 | AP | Letter | 2004/06/16 | 下载 | | 018044 | 024 | AP | Review | 1998/05/06 | 下载 | | 018044 | 019 | AP | Review | 1998/05/06 | 下载 | | 018044 | 018 | AP | Review | 1998/05/06 | 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 | | 018044 | 038 | AP | 2010/02/22 | Labeling Revision | | 018044 | 032 | AP | 2004/07/07 | Labeling Revision | | 018044 | 030 | AP | 2001/11/12 | Package Change | | 018044 | 029 | AP | 2001/10/15 | Manufacturing Change or Addition | | 018044 | 028 | AP | 2002/02/01 | Labeling Revision | | 018044 | 027 | AP | 2000/12/15 | Control Supplement | | 018044 | 026 | AP | 1999/04/27 | Manufacturing Change or Addition | | 018044 | 025 | AP | 1998/11/20 | New or Modified Indication | | 018044 | 024 | AP | 1996/10/22 | Labeling Revision | | 018044 | 023 | AP | 1995/05/26 | Control Supplement | | 018044 | 022 | AP | 1995/12/15 | Control Supplement | | 018044 | 021 | AP | 1993/09/24 | Control Supplement | | 018044 | 020 | AP | 1991/09/24 | Control Supplement | | 018044 | 019 | AP | 1990/03/13 | Control Supplement | | 018044 | 018 | AP | 1991/04/08 | Labeling Revision | | 018044 | 017 | AP | 1988/04/27 | Labeling Revision | | 018044 | 016 | AP | 1988/04/27 | Control Supplement | | 018044 | 015 | AP | 1986/05/16 | Labeling Revision | | 018044 | 014 | AP | 1985/12/20 | Manufacturing Change or Addition | | 018044 | 012 | AP | 1986/01/22 | General Efficacy (MarkIV) | | 018044 | 011 | AP | 1984/08/20 | Package Change | | 018044 | 010 | AP | 1986/09/16 | Control Supplement | | 018044 | 009 | AP | 1983/11/04 | Labeling Revision | | 018044 | 008 | AP | 1982/04/22 | Labeling Revision | | 018044 | 006 | AP | 1980/12/10 | Control Supplement | | 018044 | 005 | AP | 1980/05/12 | Manufacturing Change or Addition | | 018044 | 002 | AP | 1979/11/09 | Control Supplement | | 018044 | 001 | AP | 1978/12/06 | Control Supplement | | 018044 | 000 | AP | 1978/08/17 | Approval |
|