| NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE |
215700 |
003 |
NDA |
NOREPINEPHRINE BITARTRATE |
SOLUTION;INTRAVENOUS |
EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) |
Yes
|
Yes
|
2022/09/15
|
2022/09/15
|
INFORLIFE |
Prescription |
| NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE |
215700 |
004 |
NDA |
NOREPINEPHRINE BITARTRATE |
SOLUTION;INTRAVENOUS |
EQ 32MG BASE/250ML (EQ 128MCG BASE/ML) |
Yes
|
Yes
|
2022/09/15
|
2025/10/15
|
INFORLIFE |
Prescription |
| NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE |
214628 |
001 |
NDA |
NOREPINEPHRINE BITARTRATE |
SOLUTION;INTRAVENOUS |
EQ 4MG BASE/250 ML (EQ 16MCG BASE/ML) |
Yes
|
Yes
|
2022/10/06
|
2022/10/06
|
LONG GROVE PHARMS |
Prescription |
| NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE |
214628 |
002 |
NDA |
NOREPINEPHRINE BITARTRATE |
SOLUTION;INTRAVENOUS |
EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) |
Yes
|
Yes
|
2022/10/06
|
2022/10/06
|
LONG GROVE PHARMS |
Prescription |
| NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE |
214628 |
003 |
NDA |
NOREPINEPHRINE BITARTRATE |
SOLUTION;INTRAVENOUS |
EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) |
Yes
|
Yes
|
2022/10/06
|
2022/10/06
|
LONG GROVE PHARMS |
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 |
Prescription |
| 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 |
Prescription |
| 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 |
Prescription |
| MIDAZOLAM IN 0.9% SODIUM CHLORIDE |
216159 |
001 |
ANDA |
MIDAZOLAM |
SOLUTION;INTRAVENOUS |
50MG/50ML (1MG/ML) |
No
|
No
|
2023/04/17
|
2023/04/17
|
HIKMA |
Prescription |
| MIDAZOLAM IN 0.9% SODIUM CHLORIDE |
216159 |
002 |
ANDA |
MIDAZOLAM |
SOLUTION;INTRAVENOUS |
100MG/100ML (1MG/ML) |
No
|
No
|
2023/04/17
|
2023/04/17
|
HIKMA |
Prescription |
| SODIUM CHLORIDE 23.4% |
217796 |
001 |
ANDA |
SODIUM CHLORIDE |
INJECTABLE;INJECTION |
234MG/ML |
No
|
No
|
2023/07/11
|
2023/07/11
|
FRESENIUS KABI USA |
Prescription |
| SODIUM CHLORIDE 0.9% |
217535 |
001 |
ANDA |
SODIUM CHLORIDE |
SOLUTION;INJECTION |
90MG/10ML (9MG/ML) |
No
|
No
|
2023/08/23
|
2023/08/23
|
NEXUS |
Prescription |
| SODIUM CHLORIDE 0.9% |
217535 |
002 |
ANDA |
SODIUM CHLORIDE |
SOLUTION;INJECTION |
180MG/20ML (9MG/ML) |
No
|
No
|
2023/08/23
|
2023/08/23
|
NEXUS |
Prescription |
| CALCIUM GLUCONATE IN SODIUM CHLORIDE |
217174 |
001 |
ANDA |
CALCIUM GLUCONATE |
SOLUTION;INTRAVENOUS |
1GM/50ML (20MG/ML) |
No
|
Yes
|
2023/09/05
|
2023/09/05
|
AMNEAL |
Prescription |
| CALCIUM GLUCONATE IN SODIUM CHLORIDE |
217174 |
002 |
ANDA |
CALCIUM GLUCONATE |
SOLUTION;INTRAVENOUS |
2GM/100ML (20MG/ML) |
No
|
Yes
|
2023/09/05
|
2023/09/05
|
AMNEAL |
Prescription |
| MICAFUNGIN IN SODIUM CHLORIDE 0.9% |
216142 |
001 |
NDA |
MICAFUNGIN SODIUM |
SOLUTION;INTRAVENOUS |
EQ 50MG BASE/50ML (EQ 1MG BASE/ML) |
Yes
|
Yes
|
2023/09/29
|
2023/09/29
|
BAXTER HLTHCARE CORP |
Prescription |
| MICAFUNGIN IN SODIUM CHLORIDE 0.9% |
216142 |
002 |
NDA |
MICAFUNGIN SODIUM |
SOLUTION;INTRAVENOUS |
EQ 100MG BASE/100ML (EQ 1MG BASE/ML) |
Yes
|
Yes
|
2023/09/29
|
2023/09/29
|
BAXTER HLTHCARE CORP |
Prescription |
| MICAFUNGIN IN SODIUM CHLORIDE 0.9% |
216142 |
003 |
NDA |
MICAFUNGIN SODIUM |
SOLUTION;INTRAVENOUS |
EQ 150MG BASE/150ML (EQ 1MG BASE/ML) |
Yes
|
Yes
|
2023/09/29
|
2023/09/29
|
BAXTER HLTHCARE CORP |
Prescription |
| VASOPRESSIN IN SODIUM CHLORIDE 0.9% |
217569 |
001 |
NDA |
VASOPRESSIN |
SOLUTION;INTRAVENOUS |
20UNITS/100ML (0.2UNITS/ML) |
Yes
|
Yes
|
2023/09/29
|
2023/09/29
|
BAXTER HLTHCARE CORP |
Prescription |
| VASOPRESSIN IN SODIUM CHLORIDE 0.9% |
217569 |
002 |
NDA |
VASOPRESSIN |
SOLUTION;INTRAVENOUS |
40UNITS/100ML (0.4UNITS/ML) |
Yes
|
Yes
|
2023/09/29
|
2023/09/29
|
BAXTER HLTHCARE CORP |
Prescription |