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 |
|---|
| 2009/01/15 |
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 |
|---|
| 2025/03/04 |
SUPPL-22（补充） |
Approval |
Labeling-Package Insert,Labeling-Medication Guide |
STANDARD
|
|
|
| 2023/04/06 |
SUPPL-17（补充） |
Approval |
Labeling-Medication Guide,Labeling-Package Insert |
STANDARD
|
|
|
| 2023/04/06 |
SUPPL-16（补充） |
Approval |
Labeling-Package Insert,Labeling-Medication Guide |
STANDARD
|
|
|
| 2023/04/06 |
SUPPL-15（补充） |
Approval |
Labeling-Package Insert,Labeling-Medication Guide |
STANDARD
|
|
|
| 2014/09/26 |
SUPPL-13（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2014/09/26 |
SUPPL-11（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2014/09/26 |
SUPPL-9（补充） |
Approval |
Labeling-Package Insert,Labeling-Medication Guide |
STANDARD
|
|
|
| 2014/09/26 |
SUPPL-6（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2010/11/17 |
SUPPL-4（补充） |
Approval |
Labeling-Package Insert |
|
|
|
| 2010/02/16 |
SUPPL-3（补充） |
Approval |
REMS-Proposal |
|
|
|
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:SOLUTION;ORAL; 规格:100MG/ML; 治疗等效代码:AA<<<
| 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 |
|---|
| 218080 |
001 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
SOLUTION;ORAL |
100MG/ML |
Prescription |
No |
No |
AA |
--
|
GUARDIAN DRUG |
| 021505 |
001 |
NDA |
KEPPRA |
LEVETIRACETAM |
SOLUTION;ORAL |
100MG/ML |
Prescription |
Yes |
Yes |
AA |
2003/07/15
|
UCB INC |
| 078582 |
001 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
SOLUTION;ORAL |
100MG/ML |
Prescription |
No |
No |
AA |
2009/01/15
|
STRIDES PHARMA |
| 078976 |
001 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
SOLUTION;ORAL |
100MG/ML |
Prescription |
No |
No |
AA |
2009/01/15
|
ACTAVIS MID ATLANTIC |
| 079063 |
001 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
SOLUTION;ORAL |
100MG/ML |
Prescription |
No |
No |
AA |
2009/01/15
|
AUROBINDO PHARMA |
| 079120 |
001 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
SOLUTION;ORAL |
100MG/ML |
Prescription |
No |
No |
AA |
2009/01/16
|
BIONPHARMA |
| 078774 |
001 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
SOLUTION;ORAL |
100MG/ML |
Prescription |
No |
No |
AA |
2009/02/10
|
TARO |
| 090263 |
001 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
SOLUTION;ORAL |
100MG/ML |
Prescription |
No |
No |
AA |
2009/04/03
|
CHARTWELL MOLECULAR |
| 090992 |
001 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
SOLUTION;ORAL |
100MG/ML |
Prescription |
No |
No |
AA |
2009/10/27
|
AMNEAL PHARMS |
| 090461 |
001 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
SOLUTION;ORAL |
100MG/ML |
Prescription |
No |
No |
AA |
2010/09/30
|
AJENAT PHARMS |
| 090893 |
001 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
SOLUTION;ORAL |
100MG/ML |
Prescription |
No |
No |
AA |
2011/10/17
|
LUPIN LTD |
| 090601 |
001 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
SOLUTION;ORAL |
100MG/ML |
Discontinued |
No |
No |
AA |
2012/02/28
|
HIKMA |
| 090079 |
001 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
SOLUTION;ORAL |
100MG/ML |
Prescription |
No |
No |
AA |
2012/04/11
|
QUAGEN |
| 203052 |
001 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
SOLUTION;ORAL |
100MG/ML |
Prescription |
No |
No |
AA |
2013/02/28
|
HETERO LABS LTD III |
| 203067 |
001 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
SOLUTION;ORAL |
100MG/ML |
Prescription |
No |
No |
AA |
2013/05/09
|
ALEMBIC |
| 201157 |
001 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
SOLUTION;ORAL |
100MG/ML |
Prescription |
No |
No |
AA |
2015/06/04
|
PHARM ASSOC |
| 214757 |
001 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
SOLUTION;ORAL |
100MG/ML |
Prescription |
No |
No |
AA |
2022/07/15
|
MSN |
| 214673 |
001 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
SOLUTION;ORAL |
100MG/ML |
Discontinued |
No |
No |
AA |
2023/11/20
|
STRIDES PHARMA |
