药品名称 | INDOCIN | 申请号 | 016059 | 产品号 | 001 | 活性成分 | INDOMETHACIN | 市场状态 | 停止上市 | 剂型或给药途径 | CAPSULE;ORAL | 规格 | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 治疗等效代码 | | 参比药物 | 否 | 批准日期 | Approved Prior to Jan 1, 1982 | 申请机构 | IROKO PHARMACEUTICALS LLC
| 化学类型 | New molecular entity (NME) | 审评分类 | Priority 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 | 016059 | 099 | AP | Letter | 2016/05/11 | 下载 | 016059 | 099 | AP | Label | 2016/05/11 | 下载 | 016059 | 098 | AP | Letter | 2016/05/11 | 下载 | 016059 | 098 | AP | Label | 2016/05/11 | 下载 | 016059 | 097 | AP | Label | 2007/02/02 | 下载 | 016059 | 097 | AP | Letter | 2007/02/02 | 下载 | 016059 | 096 | AP | Label | 2006/01/27 | 下载 | 016059 | 095 | AP | Letter | 2005/03/29 | 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 | 016059 | 099 | AP | 2016/05/09 | Labeling Revision | 016059 | 098 | AP | 2016/05/09 | Labeling Revision | 016059 | 097 | AP | 2007/01/30 | Labeling Revision | 016059 | 096 | AP | 2006/01/26 | Labeling Revision | 016059 | 095 | AP | 2005/03/24 | Labeling Revision | 016059 | 090 | AP | 1997/12/01 | Control Supplement | 016059 | 089 | AP | 1996/03/01 | Manufacturing Change or Addition | 016059 | 088 | AP | 2001/10/31 | Labeling Revision | 016059 | 087 | AP | 1994/10/24 | Labeling Revision | 016059 | 086 | AP | 1994/09/13 | Labeling Revision | 016059 | 085 | AP | 1994/08/18 | Control Supplement | 016059 | 084 | AP | 1994/12/30 | Control Supplement | 016059 | 083 | AP | 1994/09/14 | Labeling Revision | 016059 | 082 | AP | 1994/09/26 | Labeling Revision | 016059 | 079 | AP | 1991/04/04 | Manufacturing Change or Addition | 016059 | 078 | AP | 1989/05/25 | Labeling Revision | 016059 | 077 | AP | 1989/01/06 | Labeling Revision | 016059 | 075 | AP | 1989/01/09 | Labeling Revision | 016059 | 074 | AP | 1988/05/03 | Manufacturing Change or Addition | 016059 | 073 | AP | 1989/01/06 | Labeling Revision | 016059 | 071 | AP | 1988/06/03 | Labeling Revision | 016059 | 068 | AP | 1986/09/22 | Labeling Revision | 016059 | 067 | AP | 1986/08/15 | Labeling Revision | 016059 | 065 | AP | 1986/06/04 | Labeling Revision | 016059 | 062 | AP | 1986/08/15 | Labeling Revision | 016059 | 061 | AP | 1985/07/23 | Labeling Revision | 016059 | 060 | AP | 1984/11/27 | Labeling Revision | 016059 | 059 | AP | 1984/12/06 | Labeling Revision | 016059 | 058 | AP | 1984/06/25 | Manufacturing Change or Addition | 016059 | 054 | AP | 1983/05/11 | Manufacturing Change or Addition | 016059 | 052 | AP | 1983/01/19 | Package Change | 016059 | 051 | AP | 1983/11/18 | Labeling Revision | 016059 | 050 | AP | 1983/01/31 | Control Supplement | 016059 | 047 | AP | 1984/08/13 | Package Change | 016059 | 046 | AP | 1982/03/03 | Manufacturing Change or Addition | 016059 | 045 | AP | 1986/01/06 | General Efficacy (MarkIV) | 016059 | 044 | AP | 1981/04/09 | Control Supplement | 016059 | 043 | AP | 1980/09/27 | Labeling Revision | 016059 | 042 | AP | 1983/07/29 | Package Change | 016059 | 041 | AP | 1981/05/28 | Labeling Revision | 016059 | 040 | AP | 1979/10/26 | Labeling Revision | 016059 | 039 | AP | 1979/08/08 | Labeling Revision | 016059 | 038 | AP | 1979/09/24 | Manufacturing Change or Addition | 016059 | 036 | AP | 1979/01/29 | Control Supplement | 016059 | 035 | AP | 1978/02/23 | Control Supplement | 016059 | 034 | AP | 1979/10/26 | Package Change | 016059 | 033 | AP | 1978/10/11 | Control Supplement | 016059 | 031 | AP | 1977/12/22 | Labeling Revision | 016059 | 030 | AP | 1976/06/29 | Labeling Revision | 016059 | 029 | AP | 1981/10/07 | Labeling Revision | 016059 | 028 | AP | 1976/08/27 | Control Supplement | 016059 | 000 | AP | 1965/06/10 | Approval |
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