批准日期,申请提交历史,通知信,药品说明书,审评文件等信息
提交状态日期 | 提交号 | 审批结论 | 申请内容分类 | 审评优先级;罕用药状态 | 通知信、审评文件、说明书、包装标签 | 备注 |
2022/01/13 |
SUPPL-12(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2020/09/11 |
SUPPL-11(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2020/09/11 |
SUPPL-10(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/03/02 |
SUPPL-7(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/03/02 |
SUPPL-5(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2012/08/20 |
SUPPL-4(补充) |
Approval |
Labeling |
|
|
|
2007/04/12 |
ORIG-1(原始申请) |
Approval |
|
|
|
|
与本品相关的专利信息(来自FDA橙皮书Orange Book)
关联产品号 | 专利号 | 专利过期日 | 是否物质专利 | 是否产品专利 | 专利用途代码 | 撤销请求 | 提交日期 | 专利下载 | 备注 |
无 |
与本品治疗等效的药品
活性成分:CEFTRIAXONE SODIUM 剂型/给药途径:INJECTABLE;INTRAMUSCULAR, INTRAVENOUS 规格:EQ 250MG BASE/VIAL 治疗等效代码:AP
申请号 | 产品号 | 申请类型 | 商品名 | 活性成分 | 剂型/给药途径 | 规格 | 市场状态 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
065169 |
001 |
ANDA |
CEFTRIAXONE |
CEFTRIAXONE SODIUM |
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS |
EQ 250MG BASE/VIAL |
Prescription |
No |
Yes |
AP |
2005/05/09
|
SANDOZ |
065391 |
001 |
ANDA |
CEFTRIAXONE |
CEFTRIAXONE SODIUM |
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS |
EQ 250MG BASE/VIAL |
Prescription |
No |
No |
AP |
2007/04/12
|
WOCKHARDT |
065342 |
001 |
ANDA |
CEFTRIAXONE |
CEFTRIAXONE SODIUM |
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS |
EQ 250MG BASE/VIAL |
Prescription |
No |
No |
AP |
2008/01/10
|
HIKMA FARMACEUTICA |
065305 |
001 |
ANDA |
CEFTRIAXONE |
CEFTRIAXONE SODIUM |
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS |
EQ 250MG BASE/VIAL |
Prescription |
No |
No |
AP |
2008/01/11
|
EPIC PHARMA LLC |
203702 |
001 |
ANDA |
CEFTRIAXONE |
CEFTRIAXONE SODIUM |
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS |
EQ 250MG BASE/VIAL |
Prescription |
No |
No |
AP |
2016/06/29
|
QILU |
091049 |
001 |
ANDA |
CEFTRIAXONE |
CEFTRIAXONE SODIUM |
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS |
EQ 250MG BASE/VIAL |
Discontinued |
No |
No |
AP |
2018/06/11
|
ASTRAL |
210197 |
001 |
ANDA |
CEFTRIAXONE |
CEFTRIAXONE SODIUM |
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS |
EQ 250MG BASE/VIAL |
Discontinued |
No |
No |
AP |
2024/01/12
|
DEVA HOLDING AS |
活性成分:CEFTRIAXONE SODIUM 剂型/给药途径:INJECTABLE;INTRAMUSCULAR, INTRAVENOUS 规格:EQ 500MG BASE/VIAL 治疗等效代码:AP
申请号 | 产品号 | 申请类型 | 商品名 | 活性成分 | 剂型/给药途径 | 规格 | 市场状态 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
065169 |
002 |
ANDA |
CEFTRIAXONE |
CEFTRIAXONE SODIUM |
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS |
EQ 500MG BASE/VIAL |
Prescription |
No |
Yes |
AP |
2005/05/09
|
SANDOZ |
065391 |
002 |
ANDA |
CEFTRIAXONE |
CEFTRIAXONE SODIUM |
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS |
EQ 500MG BASE/VIAL |
Prescription |
No |
No |
AP |
2007/04/12
|
WOCKHARDT |
065342 |
002 |
ANDA |
CEFTRIAXONE |
CEFTRIAXONE SODIUM |
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS |
EQ 500MG BASE/VIAL |
Prescription |
No |
No |
AP |
2008/01/10
|
HIKMA FARMACEUTICA |
065305 |
002 |
ANDA |
CEFTRIAXONE |
CEFTRIAXONE SODIUM |
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS |
EQ 500MG BASE/VIAL |
Prescription |
No |
No |
AP |
2008/01/11
|
EPIC PHARMA LLC |
203702 |
002 |
ANDA |
CEFTRIAXONE |
CEFTRIAXONE SODIUM |
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS |
EQ 500MG BASE/VIAL |
Prescription |
No |
No |
AP |
2016/06/29
|
QILU |
091049 |
002 |
ANDA |
CEFTRIAXONE |
CEFTRIAXONE SODIUM |
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS |
EQ 500MG BASE/VIAL |
Discontinued |
No |
No |
AP |
2018/06/11
|
ASTRAL |
210197 |
002 |
ANDA |
CEFTRIAXONE |
CEFTRIAXONE SODIUM |
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS |
EQ 500MG BASE/VIAL |
Discontinued |
No |
No |
AP |
2024/01/12
|
DEVA HOLDING AS |
活性成分:CEFTRIAXONE SODIUM 剂型/给药途径:INJECTABLE;INTRAMUSCULAR, INTRAVENOUS 规格:EQ 2GM BASE/VIAL 治疗等效代码:AP
申请号 | 产品号 | 申请类型 | 商品名 | 活性成分 | 剂型/给药途径 | 规格 | 市场状态 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
065169 |
004 |
ANDA |
CEFTRIAXONE |
CEFTRIAXONE SODIUM |
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS |
EQ 2GM BASE/VIAL |
Prescription |
No |
Yes |
AP |
2005/05/09
|
SANDOZ |
065391 |
003 |
ANDA |
CEFTRIAXONE |
CEFTRIAXONE SODIUM |
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS |
EQ 2GM BASE/VIAL |
Prescription |
No |
No |
AP |
2007/04/12
|
WOCKHARDT |
065342 |
004 |
ANDA |
CEFTRIAXONE |
CEFTRIAXONE SODIUM |
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS |
EQ 2GM BASE/VIAL |
Prescription |
No |
No |
AP |
2008/01/10
|
HIKMA FARMACEUTICA |
065305 |
004 |
ANDA |
CEFTRIAXONE |
CEFTRIAXONE SODIUM |
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS |
EQ 2GM BASE/VIAL |
Prescription |
No |
No |
AP |
2008/01/11
|
EPIC PHARMA LLC |
203702 |
004 |
ANDA |
CEFTRIAXONE |
CEFTRIAXONE SODIUM |
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS |
EQ 2GM BASE/VIAL |
Prescription |
No |
No |
AP |
2016/06/29
|
QILU |
091049 |
004 |
ANDA |
CEFTRIAXONE |
CEFTRIAXONE SODIUM |
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS |
EQ 2GM BASE/VIAL |
Discontinued |
No |
No |
AP |
2018/06/11
|
ASTRAL |
210197 |
004 |
ANDA |
CEFTRIAXONE |
CEFTRIAXONE SODIUM |
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS |
EQ 2GM BASE/VIAL |
Discontinued |
No |
No |
AP |
2024/01/12
|
DEVA HOLDING AS |