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
>>>原始批准或临时批准<<<
| 审批日期 | 提交号 | 审批结论 | 提交分类 | 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 |
|---|
| 2011/08/05 |
ORIG-1（原始申请） |
Approval |
|
|
|
|
>>>补充申请<<<
| 审批日期 | 提交号 | 审批结论 | 补充类别或审批类型 | 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 |
|---|
| 2020/07/24 |
SUPPL-4（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2020/07/24 |
SUPPL-3（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
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:LEVETIRACETAM; 剂型/给药途径:INJECTABLE;INTRAVENOUS; 规格:500MG/5ML (100MG/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 |
|---|
| 215465 |
001 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
500MG/5ML (100MG/ML) |
Prescription |
No |
No |
AP |
--
|
KNACK |
| 021872 |
001 |
NDA |
KEPPRA |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
500MG/5ML (100MG/ML) |
Prescription |
Yes |
Yes |
AP |
2006/07/31
|
UCB INC |
| 090754 |
001 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
500MG/5ML (100MG/ML) |
Discontinued |
No |
No |
AP |
2010/06/16
|
SUN PHARM INDS LTD |
| 091485 |
001 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
500MG/5ML (100MG/ML) |
Prescription |
No |
No |
AP |
2011/08/05
|
XGEN PHARMS |
| 090981 |
001 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
500MG/5ML (100MG/ML) |
Prescription |
No |
No |
AP |
2011/10/13
|
HIKMA FARMACEUTICA |
| 202869 |
001 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
500MG/5ML (100MG/ML) |
Prescription |
No |
No |
AP |
2012/04/06
|
HOSPIRA INC |
| 091627 |
001 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
500MG/5ML (100MG/ML) |
Prescription |
No |
No |
AP |
2013/06/26
|
SAGENT PHARMS |
| 090876 |
001 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
500MG/5ML (100MG/ML) |
Prescription |
No |
No |
AP |
2015/08/13
|
FRESENIUS KABI USA |
| 204312 |
001 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
500MG/5ML (100MG/ML) |
Prescription |
No |
No |
AP |
2016/02/01
|
EUGIA PHARMA |
| 203308 |
001 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
500MG/5ML (100MG/ML) |
Prescription |
No |
No |
AP |
2016/09/16
|
MYLAN LABS LTD |
| 209781 |
001 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
500MG/5ML (100MG/ML) |
Prescription |
No |
No |
AP |
2018/03/20
|
HAINAN POLY PHARM |
| 211954 |
001 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
500MG/5ML (100MG/ML) |
Prescription |
No |
No |
AP |
2019/08/09
|
MICRO LABS |
| 209474 |
001 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
500MG/5ML (100MG/ML) |
Prescription |
No |
No |
AP |
2022/03/28
|
PRINSTON INC |
| 215980 |
001 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
500MG/5ML (100MG/ML) |
Prescription |
No |
No |
AP |
2022/11/15
|
MSN |