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 |
|---|
| 2023/01/31 |
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:INJECTABLE;INTRAVENOUS 规格:500MG/100ML (5MG/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 |
|---|
| 202543 |
001 |
NDA |
LEVETIRACETAM IN SODIUM CHLORIDE |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
500MG/100ML (5MG/ML) |
Prescription |
Yes |
Yes |
AP |
2011/11/09
|
HQ SPCLT PHARMA |
| 207160 |
001 |
ANDA |
LEVETIRACETAM IN SODIUM CHLORIDE |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
500MG/100ML (5MG/ML) |
Prescription |
No |
No |
AP |
2017/01/04
|
EUGIA PHARMA |
| 206880 |
001 |
ANDA |
LEVETIRACETAM IN SODIUM CHLORIDE |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
500MG/100ML (5MG/ML) |
Prescription |
No |
No |
AP |
2017/10/25
|
GLAND PHARMA LTD |
| 213532 |
001 |
ANDA |
LEVETIRACETAM IN SODIUM CHLORIDE |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
500MG/100ML (5MG/ML) |
Prescription |
No |
No |
AP |
2020/07/06
|
NEXUS |
| 208619 |
001 |
ANDA |
LEVETIRACETAM IN SODIUM CHLORIDE |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
500MG/100ML (5MG/ML) |
Discontinued |
No |
No |
AP |
2023/01/31
|
FRESENIUS KABI USA |
| 217059 |
001 |
ANDA |
LEVETIRACETAM IN SODIUM CHLORIDE |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
500MG/100ML (5MG/ML) |
Prescription |
No |
No |
AP |
2023/10/02
|
BAXTER HLTHCARE CORP |
| 211356 |
001 |
ANDA |
LEVETIRACETAM IN SODIUM CHLORIDE |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
500MG/100ML (5MG/ML) |
Prescription |
No |
No |
AP |
2024/02/12
|
HIKMA |
| 209705 |
001 |
ANDA |
LEVETIRACETAM IN SODIUM CHLORIDE |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
500MG/100ML (5MG/ML) |
Prescription |
No |
No |
AP |
2024/02/27
|
B BRAUN MEDICAL INC |
活性成分:LEVETIRACETAM 剂型/给药途径:INJECTABLE;INTRAVENOUS 规格:1GM/100ML (10MG/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 |
|---|
| 202543 |
002 |
NDA |
LEVETIRACETAM IN SODIUM CHLORIDE |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
1GM/100ML (10MG/ML) |
Prescription |
Yes |
Yes |
AP |
2011/11/09
|
HQ SPCLT PHARMA |
| 207160 |
002 |
ANDA |
LEVETIRACETAM IN SODIUM CHLORIDE |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
1GM/100ML (10MG/ML) |
Prescription |
No |
No |
AP |
2017/01/04
|
EUGIA PHARMA |
| 206880 |
002 |
ANDA |
LEVETIRACETAM IN SODIUM CHLORIDE |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
1GM/100ML (10MG/ML) |
Prescription |
No |
No |
AP |
2017/10/25
|
GLAND PHARMA LTD |
| 213532 |
002 |
ANDA |
LEVETIRACETAM IN SODIUM CHLORIDE |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
1GM/100ML (10MG/ML) |
Prescription |
No |
No |
AP |
2020/07/06
|
NEXUS |
| 208619 |
002 |
ANDA |
LEVETIRACETAM IN SODIUM CHLORIDE |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
1GM/100ML (10MG/ML) |
Discontinued |
No |
No |
AP |
2023/01/31
|
FRESENIUS KABI USA |
| 217059 |
002 |
ANDA |
LEVETIRACETAM IN SODIUM CHLORIDE |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
1GM/100ML (10MG/ML) |
Prescription |
No |
No |
AP |
2023/10/02
|
BAXTER HLTHCARE CORP |
| 211356 |
002 |
ANDA |
LEVETIRACETAM IN SODIUM CHLORIDE |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
1GM/100ML (10MG/ML) |
Prescription |
No |
No |
AP |
2024/02/12
|
HIKMA |
| 209705 |
002 |
ANDA |
LEVETIRACETAM IN SODIUM CHLORIDE |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
1GM/100ML (10MG/ML) |
Prescription |
No |
No |
AP |
2024/02/27
|
B BRAUN MEDICAL INC |
活性成分:LEVETIRACETAM 剂型/给药途径:INJECTABLE;INTRAVENOUS 规格:1.5GM/100ML (15MG/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 |
|---|
| 202543 |
003 |
NDA |
LEVETIRACETAM IN SODIUM CHLORIDE |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
1.5GM/100ML (15MG/ML) |
Prescription |
Yes |
Yes |
AP |
2011/11/09
|
HQ SPCLT PHARMA |
| 207160 |
003 |
ANDA |
LEVETIRACETAM IN SODIUM CHLORIDE |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
1.5GM/100ML (15MG/ML) |
Prescription |
No |
No |
AP |
2017/01/04
|
EUGIA PHARMA |
| 206880 |
003 |
ANDA |
LEVETIRACETAM IN SODIUM CHLORIDE |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
1.5GM/100ML (15MG/ML) |
Prescription |
No |
No |
AP |
2017/10/25
|
GLAND PHARMA LTD |
| 213532 |
003 |
ANDA |
LEVETIRACETAM IN SODIUM CHLORIDE |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
1.5GM/100ML (15MG/ML) |
Prescription |
No |
No |
AP |
2020/07/06
|
NEXUS |
| 208619 |
003 |
ANDA |
LEVETIRACETAM IN SODIUM CHLORIDE |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
1.5GM/100ML (15MG/ML) |
Discontinued |
No |
No |
AP |
2023/01/31
|
FRESENIUS KABI USA |
| 217059 |
003 |
ANDA |
LEVETIRACETAM IN SODIUM CHLORIDE |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
1.5GM/100ML (15MG/ML) |
Prescription |
No |
No |
AP |
2023/10/02
|
BAXTER HLTHCARE CORP |
| 211356 |
003 |
ANDA |
LEVETIRACETAM IN SODIUM CHLORIDE |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
1.5GM/100ML (15MG/ML) |
Prescription |
No |
No |
AP |
2024/02/12
|
HIKMA |
| 209705 |
003 |
ANDA |
LEVETIRACETAM IN SODIUM CHLORIDE |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
1.5GM/100ML (15MG/ML) |
Prescription |
No |
No |
AP |
2024/02/27
|
B BRAUN MEDICAL INC |