药品名称 | ROCEPHIN | 申请号 | 050585 | 产品号 | 002 | 活性成分 | CEFTRIAXONE SODIUM | 市场状态 | 停止上市 | 剂型或给药途径 | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | 规格 | EQ 500MG BASE/VIAL | 治疗等效代码 | | 参比药物 | 否 | 批准日期 | 1984/12/21 | 申请机构 | HOFFMANN LA ROCHE INC
| 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 | 050585 | 067 | AP | Label | 2015/07/01 | 下载 | 050585 | 067 | AP | Letter | 2015/07/08 | 下载 | 050585 | 066 | AP | Label | 2015/03/23 | 下载 | 050585 | 066 | AP | Letter | 2015/03/24 | 下载 | 050585 | 065 | AP | Letter | 2013/04/16 | 下载 | 050585 | 065 | AP | Label | 2013/04/16 | 下载 | 050585 | 064 | AP | Label | 2010/03/03 | 下载 | 050585 | 064 | AP | Letter | 2010/03/04 | 下载 | 050585 | 063 | AP | Label | 2009/06/10 | 下载 | 050585 | 063 | AP | Letter | 2009/06/16 | 下载 | 050585 | 062 | AP | Label | 2010/11/17 | 下载 | 050585 | 062 | AP | Letter | 2010/11/18 | 下载 | 050585 | 061 | AP | Letter | 2009/03/13 | 下载 | 050585 | 061 | AP | Label | 2009/04/03 | 下载 | 050585 | 060 | AP | Letter | 2008/08/20 | 下载 | 050585 | 060 | AP | Label | 2008/08/26 | 下载 | 050585 | 059 | AP | Letter | 2007/05/16 | 下载 | 050585 | 059 | AP | Label | 2007/05/16 | 下载 | 050585 | 058 | AP | Letter | 2007/07/24 | 下载 | 050585 | 058 | AP | Label | 2007/07/24 | 下载 | 050585 | 057 | AP | Letter | 2004/09/15 | 下载 | 050585 | 057 | AP | Label | 2004/09/15 | 下载 | 050585 | 056 | AP | Label | 2004/09/03 | 下载 | 050585 | 056 | AP | Letter | 2004/09/03 | 下载 | 050585 | 054 | AP | Label | 2004/04/05 | 下载 | 050585 | 054 | AP | Letter | 2004/04/07 | 下载 | 050585 | 050 | AP | Label | 2008/08/26 | 下载 | 050585 | 000 | AP | Other Important Information from FDA | 2007/09/11 | 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 | 050585 | 067 | AP | 2015/06/30 | Labeling Revision | 050585 | 066 | AP | 2015/03/20 | Labeling Revision | 050585 | 065 | AP | 2013/04/12 | Labeling Revision | 050585 | 064 | AP | 2010/02/25 | Labeling Revision | 050585 | 063 | AP | 2009/06/07 | Labeling Revision | 050585 | 062 | AP | 2010/11/12 | Labeling Revision | 050585 | 061 | AP | 2009/03/11 | Labeling Revision | 050585 | 060 | AP | 2008/08/18 | Labeling Revision | 050585 | 059 | AP | 2007/05/11 | Labeling Revision | 050585 | 058 | AP | 2007/07/17 | Labeling Revision | 050585 | 057 | AP | 2004/09/14 | Supplement | 050585 | 056 | AP | 2004/09/02 | Labeling Revision | 050585 | 054 | AP | 2004/03/29 | Labeling Revision | 050585 | 050 | AP | 2008/08/18 | Labeling Revision | 050585 | 049 | AP | 1999/10/18 | Control Supplement | 050585 | 048 | AP | 1998/04/28 | Control Supplement | 050585 | 047 | AP | 2000/08/25 | Labeling Revision | 050585 | 046 | AP | 1997/12/23 | New Dosage Regimen | 050585 | 045 | AP | 1995/09/14 | Labeling Revision | 050585 | 044 | AP | 1996/05/08 | New Dosage Regimen | 050585 | 043 | AP | 1994/08/18 | Labeling Revision | 050585 | 042 | AP | 1994/02/04 | Manufacturing Change or Addition | 050585 | 041 | AP | 1993/02/08 | Manufacturing Change or Addition | 050585 | 039 | AP | 1994/04/26 | Labeling Revision | 050585 | 037 | AP | 1996/03/14 | Manufacturing Change or Addition | 050585 | 036 | AP | 1992/09/23 | Control Supplement | 050585 | 035 | AP | 1992/06/17 | New or Modified Indication | 050585 | 034 | AP | 1993/05/28 | New Dosage Regimen | 050585 | 033 | AP | 1993/10/07 | Labeling Revision | 050585 | 031 | AP | 1991/09/12 | Manufacturing Change or Addition | 050585 | 030 | AP | 1992/01/31 | Control Supplement | 050585 | 029 | AP | 1992/02/04 | Manufacturing Change or Addition | 050585 | 027 | AP | 1990/12/31 | New or Modified Indication | 050585 | 026 | AP | 1991/03/11 | Labeling Revision | 050585 | 025 | AP | 1991/03/11 | Chemistry Generic | 050585 | 023 | AP | 1992/02/11 | New or Modified Indication | 050585 | 022 | AP | 1989/06/29 | Chemistry Generic | 050585 | 021 | AP | 1989/02/07 | Chemistry Generic | 050585 | 019 | AP | 1988/08/26 | Chemistry Generic | 050585 | 018 | AP | 1991/03/11 | Labeling Revision | 050585 | 015 | AP | 1989/09/25 | Labeling Revision | 050585 | 011 | AP | 1986/10/07 | Chemistry Generic | 050585 | 010 | AP | 1986/10/07 | Chemistry Generic | 050585 | 009 | AP | 1991/11/22 | New Dosage Regimen | 050585 | 004 | AP | 1985/05/10 | Labeling Revision | 050585 | 000 | AP | 1984/12/21 | Approval |
|