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 |
|---|
| 2024/08/26 |
SUPPL-5（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2024/01/24 |
SUPPL-4（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/11/27 |
ORIG-1（原始申请） |
Approval |
|
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:TABLET, EXTENDED RELEASE;ORAL 规格:500MG 治疗等效代码:AB
| 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 |
|---|
| 022285 |
001 |
NDA |
KEPPRA XR |
LEVETIRACETAM |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
Prescription |
Yes |
No |
AB |
2008/09/12
|
UCB INC |
| 091093 |
001 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
Prescription |
No |
No |
AB |
2011/09/12
|
ACTAVIS LABS FL INC |
| 091261 |
001 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
Prescription |
No |
No |
AB |
2011/09/12
|
APOTEX INC |
| 091399 |
001 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
Prescription |
No |
No |
AB |
2011/09/12
|
LUPIN LTD |
| 091360 |
001 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
Discontinued |
No |
No |
AB |
2011/10/04
|
ENDO OPERATIONS |
| 201464 |
001 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
Discontinued |
No |
No |
AB |
2012/05/25
|
PHARMADAX INC |
| 202533 |
001 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
Discontinued |
No |
No |
AB |
2012/07/20
|
PRINSTON INC |
| 203059 |
001 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
Discontinued |
No |
No |
AB |
2013/09/09
|
SUN PHARM |
| 203468 |
001 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
Prescription |
No |
No |
AB |
2015/05/21
|
PRINSTON INC |
| 202167 |
001 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
Discontinued |
No |
No |
AB |
2015/09/04
|
ADAPTIS |
| 204511 |
001 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
Prescription |
No |
No |
AB |
2016/02/23
|
ANDA REPOSITORY |
| 204754 |
001 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
Prescription |
No |
No |
AB |
2016/08/26
|
AIPING PHARM INC |
| 207175 |
001 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
Prescription |
No |
No |
AB |
2017/09/28
|
HISUN PHARM HANGZHOU |
| 205130 |
001 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
Prescription |
No |
No |
AB |
2020/11/27
|
SCIEGEN PHARMS INC |
| 212688 |
002 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
Prescription |
No |
No |
AB |
2023/05/05
|
OVERSEAS |
活性成分:LEVETIRACETAM 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:750MG 治疗等效代码:AB
| 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 |
|---|
| 022285 |
002 |
NDA |
KEPPRA XR |
LEVETIRACETAM |
TABLET, EXTENDED RELEASE;ORAL |
750MG |
Prescription |
Yes |
Yes |
AB |
2009/02/12
|
UCB INC |
| 091093 |
002 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
TABLET, EXTENDED RELEASE;ORAL |
750MG |
Prescription |
No |
No |
AB |
2011/09/12
|
ACTAVIS LABS FL INC |
| 091261 |
002 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
TABLET, EXTENDED RELEASE;ORAL |
750MG |
Prescription |
No |
No |
AB |
2011/09/12
|
APOTEX INC |
| 091399 |
002 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
TABLET, EXTENDED RELEASE;ORAL |
750MG |
Prescription |
No |
No |
AB |
2011/09/12
|
LUPIN LTD |
| 091360 |
002 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
TABLET, EXTENDED RELEASE;ORAL |
750MG |
Discontinued |
No |
No |
AB |
2011/10/04
|
ENDO OPERATIONS |
| 201464 |
002 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
TABLET, EXTENDED RELEASE;ORAL |
750MG |
Discontinued |
No |
No |
AB |
2012/05/25
|
PHARMADAX INC |
| 202533 |
002 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
TABLET, EXTENDED RELEASE;ORAL |
750MG |
Discontinued |
No |
No |
AB |
2012/07/20
|
PRINSTON INC |
| 203059 |
002 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
TABLET, EXTENDED RELEASE;ORAL |
750MG |
Discontinued |
No |
No |
AB |
2013/09/09
|
SUN PHARM |
| 203468 |
002 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
TABLET, EXTENDED RELEASE;ORAL |
750MG |
Prescription |
No |
No |
AB |
2015/05/21
|
PRINSTON INC |
| 202167 |
002 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
TABLET, EXTENDED RELEASE;ORAL |
750MG |
Discontinued |
No |
No |
AB |
2015/09/04
|
ADAPTIS |
| 204511 |
002 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
TABLET, EXTENDED RELEASE;ORAL |
750MG |
Prescription |
No |
No |
AB |
2016/02/23
|
ANDA REPOSITORY |
| 204754 |
002 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
TABLET, EXTENDED RELEASE;ORAL |
750MG |
Prescription |
No |
No |
AB |
2016/08/26
|
AIPING PHARM INC |
| 207175 |
002 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
TABLET, EXTENDED RELEASE;ORAL |
750MG |
Prescription |
No |
No |
AB |
2017/09/28
|
HISUN PHARM HANGZHOU |
| 212688 |
001 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
TABLET, EXTENDED RELEASE;ORAL |
750MG |
Prescription |
No |
No |
AB |
2020/06/11
|
OVERSEAS |
| 205130 |
002 |
ANDA |
LEVETIRACETAM |
LEVETIRACETAM |
TABLET, EXTENDED RELEASE;ORAL |
750MG |
Prescription |
No |
No |
AB |
2020/11/27
|
SCIEGEN PHARMS INC |