| 药品名称 | MEGACE | | 申请号 | 016979 | 产品号 | 002 | | 活性成分 | MEGESTROL ACETATE | 市场状态 | 停止上市 | | 剂型或给药途径 | TABLET;ORAL | 规格 | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | | 治疗等效代码 | | 参比药物 | 否 | | 批准日期 | Approved Prior to Jan 1, 1982 | 申请机构 | BRISTOL MYERS SQUIBB
| | 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 | | 016979 | 052 | AP | Letter | 2002/01/06 | 下载 | | 016979 | 051 | AP | Letter | 2002/08/27 | 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 | | 016979 | 052 | AP | 2003/01/06 | Labeling Revision | | 016979 | 051 | AP | 2002/08/27 | Labeling Revision | | 016979 | 050 | AP | 2001/06/15 | Manufacturing Change or Addition | | 016979 | 049 | AP | 2001/01/31 | Labeling Revision | | 016979 | 048 | AP | 1999/11/15 | Labeling Revision | | 016979 | 047 | AP | 1997/09/04 | Labeling Revision | | 016979 | 046 | AP | 1994/06/27 | Labeling Revision | | 016979 | 045 | AP | 1993/08/11 | Manufacturing Change or Addition | | 016979 | 044 | AP | 1991/03/14 | Manufacturing Change or Addition | | 016979 | 042 | AP | 1991/03/04 | Control Supplement | | 016979 | 041 | AP | 1989/08/11 | Package Change | | 016979 | 040 | AP | 1989/08/08 | Labeling Revision | | 016979 | 039 | AP | 1989/01/26 | Package Change | | 016979 | 038 | AP | 1988/04/12 | Manufacturing Change or Addition | | 016979 | 037 | AP | 1988/03/07 | Control Supplement | | 016979 | 036 | AP | 1988/06/20 | Control Supplement | | 016979 | 033 | AP | 1985/11/25 | Labeling Revision | | 016979 | 031 | AP | 1987/11/13 | Labeling Revision | | 016979 | 030 | AP | 1990/09/06 | Manufacturing Change or Addition | | 016979 | 029 | AP | 1985/07/23 | Control Supplement | | 016979 | 028 | AP | 1984/12/11 | Control Supplement | | 016979 | 026 | AP | 1984/10/16 | Control Supplement | | 016979 | 025 | AP | 1990/12/11 | Practioner Draft Labeling | | 016979 | 024 | AP | 1982/11/19 | Formulation Revision | | 016979 | 023 | AP | 1984/05/24 | Control Supplement | | 016979 | 022 | AP | 1984/07/10 | Control Supplement | | 016979 | 020 | AP | 1982/02/10 | Control Supplement | | 016979 | 019 | AP | 1983/02/22 | Formulation Revision | | 016979 | 018 | AP | 1981/03/11 | Labeling Revision | | 016979 | 017 | AP | 1979/03/29 | Control Supplement | | 016979 | 016 | AP | 1980/02/26 | Labeling Revision | | 016979 | 015 | AP | 1979/06/20 | Manufacturing Change or Addition | | 016979 | 014 | AP | 1977/06/15 | Labeling Revision | | 016979 | 013 | AP | 1976/11/23 | Control Supplement | | 016979 | 012 | AP | 1976/11/23 | Control Supplement | | 016979 | 011 | AP | 1976/09/21 | Control Supplement | | 016979 | 010 | AP | 1976/07/16 | Labeling Revision | | 016979 | 009 | AP | 1976/07/07 | Control Supplement | | 016979 | 008 | AP | 1975/06/03 | Other Amendment | | 016979 | 000 | AP | 1971/08/18 | Approval |
|