| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
211968 |
001 |
ANDA |
SODIUM CHLORIDE |
SOLUTION;INJECTION |
450MG/50ML (9MG/ML) |
No
|
No
|
2020/04/23
|
2020/04/23
|
NEPHRON |
Prescription |
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
211968 |
002 |
ANDA |
SODIUM CHLORIDE |
SOLUTION;INJECTION |
900MG/100ML |
No
|
No
|
2020/04/23
|
2020/04/23
|
NEPHRON |
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 |
| HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
212441 |
001 |
ANDA |
HEPARIN SODIUM |
INJECTABLE;INJECTION |
200 UNITS/100ML |
No
|
No
|
2020/07/24
|
2020/07/24
|
FRESENIUS KABI USA |
Prescription |
| HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
212441 |
002 |
ANDA |
HEPARIN SODIUM |
INJECTABLE;INJECTION |
200 UNITS/100ML |
No
|
No
|
2020/07/24
|
2020/07/24
|
FRESENIUS KABI USA |
Prescription |
| DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER |
211194 |
001 |
ANDA |
DEXTROSE; SODIUM CHLORIDE |
INJECTABLE;INJECTION |
5GM/100ML;300MG/100ML |
No
|
No
|
2020/08/26
|
2020/08/26
|
FRESENIUS KABI USA |
Prescription |
| DEXTROSE 5% AND SODIUM CHLORIDE 0.9% |
211211 |
001 |
ANDA |
DEXTROSE; SODIUM CHLORIDE |
INJECTABLE;INJECTION |
5GM/100ML;900MG/100ML |
No
|
No
|
2020/09/14
|
2020/09/14
|
FRESENIUS KABI USA |
Prescription |
| DEXTROSE 5% AND SODIUM CHLORIDE 0.225% |
211221 |
001 |
ANDA |
DEXTROSE; SODIUM CHLORIDE |
INJECTABLE;INJECTION |
5GM/100ML;225MG/100ML |
No
|
No
|
2020/09/15
|
2020/09/15
|
FRESENIUS KABI USA |
Prescription |
| DEXTROSE 5% AND SODIUM CHLORIDE 0.45% |
211276 |
001 |
ANDA |
DEXTROSE; SODIUM CHLORIDE |
INJECTABLE;INJECTION |
5GM/100ML;450MG/100ML |
No
|
No
|
2020/09/15
|
2020/09/15
|
FRESENIUS KABI USA |
Prescription |
| POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% |
212347 |
001 |
ANDA |
POTASSIUM CHLORIDE; SODIUM CHLORIDE |
INJECTABLE;INJECTION |
150MG/100ML;450MG/100ML |
No
|
No
|
2020/09/17
|
2020/09/17
|
FRESENIUS KABI USA |
Prescription |
| POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% |
212347 |
002 |
ANDA |
POTASSIUM CHLORIDE; SODIUM CHLORIDE |
INJECTABLE;INJECTION |
300MG/100ML;900MG/100ML |
No
|
No
|
2020/09/17
|
2020/09/17
|
FRESENIUS KABI USA |
Prescription |
| POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% |
212347 |
003 |
ANDA |
POTASSIUM CHLORIDE; SODIUM CHLORIDE |
INJECTABLE;INJECTION |
150MG/100ML;900MG/100ML |
No
|
No
|
2020/09/17
|
2021/06/02
|
FRESENIUS KABI USA |
Prescription |
| LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE |
213330 |
002 |
NDA |
LABETALOL HYDROCHLORIDE |
SOLUTION;INTRAVENOUS |
100MG/100ML (1MG/ML) |
Yes
|
Yes
|
2020/11/09
|
2020/11/09
|
HIKMA |
Prescription |
| LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE |
213330 |
003 |
NDA |
LABETALOL HYDROCHLORIDE |
SOLUTION;INTRAVENOUS |
200MG/200ML (1MG/ML) |
Yes
|
Yes
|
2020/11/09
|
2020/11/09
|
HIKMA |
Prescription |
| LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE |
213330 |
004 |
NDA |
LABETALOL HYDROCHLORIDE |
SOLUTION;INTRAVENOUS |
300MG/300ML (1MG/ML) |
Yes
|
Yes
|
2020/11/09
|
2020/11/09
|
HIKMA |
Prescription |
| NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE |
214313 |
004 |
NDA |
NOREPINEPHRINE BITARTRATE |
SOLUTION;INTRAVENOUS |
EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) |
Yes
|
Yes
|
2021/01/15
|
2026/02/06
|
BAXTER HLTHCARE CORP |
Prescription |
| NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE |
214313 |
005 |
NDA |
NOREPINEPHRINE BITARTRATE |
SOLUTION;INTRAVENOUS |
EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) |
Yes
|
Yes
|
2021/01/15
|
2026/02/06
|
BAXTER HLTHCARE CORP |
Prescription |
| NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE |
214313 |
006 |
NDA |
NOREPINEPHRINE BITARTRATE |
SOLUTION;INTRAVENOUS |
EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) |
Yes
|
Yes
|
2021/01/15
|
2026/02/06
|
BAXTER HLTHCARE CORP |
Prescription |