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 |
2020/03/02 |
SUPPL-19(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/12/23 |
SUPPL-16(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2010/06/11 |
SUPPL-9(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2002/03/08 |
SUPPL-5(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2002/02/08 |
SUPPL-4(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2002/01/18 |
SUPPL-3(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2000/04/14 |
SUPPL-2(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2000/04/12 |
SUPPL-1(补充) |
Approval |
Efficacy |
STANDARD
;Orphan
|
|
|
1999/09/21 |
ORIG-1(原始申请) |
Approval |
Type 2 - New Active Ingredient |
PRIORITY
;Orphan
|
|
|
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:CAFFEINE CITRATE 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:EQ 30MG BASE/3ML (EQ 10MG BASE/ML) 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 |
020793 |
001 |
NDA |
CAFCIT |
CAFFEINE CITRATE |
SOLUTION;INTRAVENOUS |
EQ 30MG BASE/3ML (EQ 10MG BASE/ML) |
Prescription |
Yes |
Yes |
AP |
1999/09/21
|
HIKMA |
077233 |
001 |
ANDA |
CAFFEINE CITRATE |
CAFFEINE CITRATE |
SOLUTION;INTRAVENOUS |
EQ 30MG BASE/3ML (EQ 10MG BASE/ML) |
Prescription |
No |
No |
AP |
2006/09/21
|
EXELA PHARMA SCIENCE |
077906 |
001 |
ANDA |
CAFFEINE CITRATE |
CAFFEINE CITRATE |
SOLUTION;INTRAVENOUS |
EQ 30MG BASE/3ML (EQ 10MG BASE/ML) |
Prescription |
No |
No |
AP |
2007/05/15
|
AM REGENT |
077997 |
001 |
ANDA |
CAFFEINE CITRATE |
CAFFEINE CITRATE |
SOLUTION;INTRAVENOUS |
EQ 30MG BASE/3ML (EQ 10MG BASE/ML) |
Prescription |
No |
No |
AP |
2007/07/20
|
FRESENIUS KABI USA |
090827 |
001 |
ANDA |
CAFFEINE CITRATE |
CAFFEINE CITRATE |
SOLUTION;INTRAVENOUS |
EQ 30MG BASE/3ML (EQ 10MG BASE/ML) |
Prescription |
No |
No |
AP |
2012/08/29
|
SAGENT PHARMS |
205013 |
001 |
ANDA |
CAFFEINE CITRATE |
CAFFEINE CITRATE |
SOLUTION;INTRAVENOUS |
EQ 30MG BASE/3ML (EQ 10MG BASE/ML) |
Prescription |
No |
No |
AP |
2015/09/22
|
EUGIA PHARMA |
207400 |
001 |
ANDA |
CAFFEINE CITRATE |
CAFFEINE CITRATE |
SOLUTION;INTRAVENOUS |
EQ 30MG BASE/3ML (EQ 10MG BASE/ML) |
Prescription |
No |
No |
AP |
2017/12/14
|
MICRO LABS |