药品名称 | CLINORIL | 申请号 | 017911 | 产品号 | 001 | 活性成分 | SULINDAC | 市场状态 | 停止上市 | 剂型或给药途径 | TABLET;ORAL | 规格 | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 治疗等效代码 | | 参比药物 | 否 | 批准日期 | Approved Prior to Jan 1, 1982 | 申请机构 | MERCK RESEARCH LABORATORIES DIV MERCK CO INC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 | 017911 | 074 | AP | Label | 2010/12/26 | 下载 | 017911 | 074 | AP | Letter | 2010/12/28 | 下载 | 017911 | 073 | AP | Label | 2010/06/07 | 下载 | 017911 | 073 | AP | Letter | 2010/06/10 | 下载 | 017911 | 072 | AP | Letter | 2009/04/03 | 下载 | 017911 | 072 | AP | Label | 2009/04/03 | 下载 | 017911 | 070 | AP | Label | 2007/08/27 | 下载 | 017911 | 070 | AP | Letter | 2007/08/27 | 下载 | 017911 | 068 | AP | Label | 2006/01/25 | 下载 | 017911 | 068 | AP | Letter | 2006/01/30 | 下载 | 017911 | 065 | AP | Label | 2006/10/11 | 下载 | 017911 | 065 | AP | Letter | 2006/10/13 | 下载 | 017911 | 000 | AP | Medication Guide | 2009/11/16 | 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 | 017911 | 074 | AP | 2010/12/23 | Labeling Revision | 017911 | 073 | AP | 2010/06/04 | Labeling Revision | 017911 | 072 | AP | 2009/03/30 | Labeling Revision | 017911 | 070 | AP | 2007/08/23 | Labeling Revision | 017911 | 068 | AP | 2006/01/24 | Labeling Revision | 017911 | 067 | AP | 2001/02/07 | Control Supplement | 017911 | 066 | AP | 2001/10/30 | Labeling Revision | 017911 | 065 | AP | 2006/10/05 | Labeling Revision | 017911 | 064 | AP | 1997/04/14 | Control Supplement | 017911 | 063 | AP | 1997/05/02 | Control Supplement | 017911 | 062 | AP | 1996/03/01 | Manufacturing Change or Addition | 017911 | 060 | AP | 1994/10/24 | Control Supplement | 017911 | 059 | AP | 1994/08/18 | Control Supplement | 017911 | 058 | AP | 1995/07/10 | Labeling Revision | 017911 | 057 | AP | 1995/06/01 | Labeling Revision | 017911 | 055 | AP | 1992/07/27 | Control Supplement | 017911 | 052 | AP | 1989/05/31 | Labeling Revision | 017911 | 051 | AP | 1989/05/31 | Labeling Revision | 017911 | 050 | AP | 1989/01/09 | Labeling Revision | 017911 | 049 | AP | 1989/02/06 | Control Supplement | 017911 | 047 | AP | 1989/01/09 | Labeling Revision | 017911 | 046 | AP | 1989/01/09 | Labeling Revision | 017911 | 045 | AP | 1988/05/03 | Manufacturing Change or Addition | 017911 | 044 | AP | 1989/01/09 | Labeling Revision | 017911 | 043 | AP | 1989/01/09 | Labeling Revision | 017911 | 040 | AP | 1989/01/09 | Labeling Revision | 017911 | 038 | AP | 1986/02/05 | Labeling Revision | 017911 | 037 | AP | 1986/02/05 | Labeling Revision | 017911 | 035 | AP | 1986/02/05 | Labeling Revision | 017911 | 034 | AP | 1984/11/26 | Labeling Revision | 017911 | 033 | AP | 1984/07/26 | Manufacturing Change or Addition | 017911 | 031 | AP | 1984/01/26 | Labeling Revision | 017911 | 027 | AP | 1989/05/31 | Labeling Revision | 017911 | 025 | AP | 1984/08/13 | Control Supplement | 017911 | 023 | AP | 1984/05/29 | Control Supplement | 017911 | 022 | AP | 1983/06/29 | Control Supplement | 017911 | 020 | AP | 1982/06/22 | Labeling Revision | 017911 | 018 | AP | 1982/06/22 | Labeling Revision | 017911 | 017 | AP | 1982/06/29 | Labeling Revision | 017911 | 016 | AP | 1984/11/20 | Manufacturing Change or Addition | 017911 | 015 | AP | 1993/05/12 | Formulation Revision | 017911 | 014 | AP | 1981/04/27 | Package Change | 017911 | 013 | AP | 1981/06/05 | Manufacturing Change or Addition | 017911 | 011 | AP | 1981/12/21 | Package Change | 017911 | 009 | AP | 1981/12/14 | Labeling Revision | 017911 | 008 | AP | 1981/12/14 | Package Change | 017911 | 007 | AP | 1979/08/08 | Control Supplement | 017911 | 006 | AP | 1979/10/01 | Control Supplement | 017911 | 005 | AP | 1981/05/12 | Labeling Revision | 017911 | 004 | AP | 1979/08/06 | Labeling Revision | 017911 | 003 | AP | 1979/08/08 | Labeling Revision | 017911 | 002 | AP | 1979/07/23 | Manufacturing Change or Addition | 017911 | 001 | AP | 1979/08/14 | Expiration Date Change | 017911 | 000 | AP | 1978/09/27 | Approval |
|