| LEVETIRACETAM IN SODIUM CHLORIDE |
202543 |
001 |
NDA |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
500MG/100ML (5MG/ML) |
Yes
|
Yes
|
2011/11/09
|
2011/11/09
|
HQ SPCLT PHARMA |
Prescription |
| LEVETIRACETAM IN SODIUM CHLORIDE |
202543 |
002 |
NDA |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
1GM/100ML (10MG/ML) |
Yes
|
Yes
|
2011/11/09
|
2011/11/09
|
HQ SPCLT PHARMA |
Prescription |
| LEVETIRACETAM IN SODIUM CHLORIDE |
202543 |
003 |
NDA |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
1.5GM/100ML (15MG/ML) |
Yes
|
Yes
|
2011/11/09
|
2011/11/09
|
HQ SPCLT PHARMA |
Prescription |
| LEVETIRACETAM IN SODIUM CHLORIDE |
202543 |
004 |
NDA |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
250MG/50ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
Yes
|
No
|
2011/11/09
|
2020/12/14
|
HQ SPCLT PHARMA |
Discontinued |
| LEVETIRACETAM IN SODIUM CHLORIDE |
207160 |
001 |
ANDA |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
500MG/100ML (5MG/ML) |
No
|
No
|
2017/01/04
|
2017/01/04
|
EUGIA PHARMA |
Prescription |
| LEVETIRACETAM IN SODIUM CHLORIDE |
207160 |
002 |
ANDA |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
1GM/100ML (10MG/ML) |
No
|
No
|
2017/01/04
|
2017/01/04
|
EUGIA PHARMA |
Prescription |
| LEVETIRACETAM IN SODIUM CHLORIDE |
207160 |
003 |
ANDA |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
1.5GM/100ML (15MG/ML) |
No
|
No
|
2017/01/04
|
2017/01/04
|
EUGIA PHARMA |
Prescription |
| LEVETIRACETAM IN SODIUM CHLORIDE |
206880 |
001 |
ANDA |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
500MG/100ML (5MG/ML) |
No
|
No
|
2017/10/25
|
2017/10/25
|
GLAND PHARMA LTD |
Prescription |
| LEVETIRACETAM IN SODIUM CHLORIDE |
206880 |
002 |
ANDA |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
1GM/100ML (10MG/ML) |
No
|
No
|
2017/10/25
|
2017/10/25
|
GLAND PHARMA LTD |
Prescription |
| LEVETIRACETAM IN SODIUM CHLORIDE |
206880 |
003 |
ANDA |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
1.5GM/100ML (15MG/ML) |
No
|
No
|
2017/10/25
|
2017/10/25
|
GLAND PHARMA LTD |
Prescription |
| LEVETIRACETAM IN SODIUM CHLORIDE |
213532 |
001 |
ANDA |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
500MG/100ML (5MG/ML) |
No
|
No
|
2020/07/06
|
2020/07/06
|
NEXUS |
Prescription |
| LEVETIRACETAM IN SODIUM CHLORIDE |
213532 |
002 |
ANDA |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
1GM/100ML (10MG/ML) |
No
|
No
|
2020/07/06
|
2020/07/06
|
NEXUS |
Prescription |
| LEVETIRACETAM IN SODIUM CHLORIDE |
213532 |
003 |
ANDA |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
1.5GM/100ML (15MG/ML) |
No
|
No
|
2020/07/06
|
2020/07/06
|
NEXUS |
Prescription |
| LEVETIRACETAM IN SODIUM CHLORIDE |
208619 |
001 |
ANDA |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
500MG/100ML (5MG/ML) |
No
|
No
|
2023/01/31
|
2023/01/31
|
FRESENIUS KABI USA |
Discontinued |
| LEVETIRACETAM IN SODIUM CHLORIDE |
208619 |
002 |
ANDA |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
1GM/100ML (10MG/ML) |
No
|
No
|
2023/01/31
|
2023/01/31
|
FRESENIUS KABI USA |
Discontinued |
| LEVETIRACETAM IN SODIUM CHLORIDE |
208619 |
003 |
ANDA |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
1.5GM/100ML (15MG/ML) |
No
|
No
|
2023/01/31
|
2023/01/31
|
FRESENIUS KABI USA |
Discontinued |
| LEVETIRACETAM IN SODIUM CHLORIDE |
217059 |
001 |
ANDA |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
500MG/100ML (5MG/ML) |
No
|
No
|
2023/10/02
|
2023/10/02
|
BAXTER HLTHCARE CORP |
Prescription |
| LEVETIRACETAM IN SODIUM CHLORIDE |
217059 |
002 |
ANDA |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
1GM/100ML (10MG/ML) |
No
|
No
|
2023/10/02
|
2023/10/02
|
BAXTER HLTHCARE CORP |
Prescription |
| LEVETIRACETAM IN SODIUM CHLORIDE |
217059 |
003 |
ANDA |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
1.5GM/100ML (15MG/ML) |
No
|
No
|
2023/10/02
|
2023/10/02
|
BAXTER HLTHCARE CORP |
Prescription |
| LEVETIRACETAM IN SODIUM CHLORIDE |
211356 |
001 |
ANDA |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
500MG/100ML (5MG/ML) |
No
|
No
|
2024/02/12
|
2024/02/12
|
HIKMA |
Prescription |