| VASOPRESSIN IN SODIUM CHLORIDE 0.9% |
217766 |
001 |
NDA |
VASOPRESSIN |
SOLUTION;INTRAVENOUS |
20UNITS/100ML (0.2UNITS/ML) |
Yes
|
Yes
|
2024/07/11
|
2024/07/11
|
LONG GROVE PHARMS |
Prescription |
| VASOPRESSIN IN SODIUM CHLORIDE 0.9% |
217766 |
002 |
NDA |
VASOPRESSIN |
SOLUTION;INTRAVENOUS |
40UNITS/100ML (0.4UNITS/ML) |
Yes
|
Yes
|
2024/07/11
|
2024/07/11
|
LONG GROVE PHARMS |
Prescription |
| VASOPRESSIN IN SODIUM CHLORIDE 0.9% |
217766 |
003 |
NDA |
VASOPRESSIN |
SOLUTION;INTRAVENOUS |
50UNITS/50ML (1UNIT/ML) |
Yes
|
No
|
2024/07/11
|
2024/07/11
|
LONG GROVE PHARMS |
Discontinued |
| POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE |
218343 |
001 |
NDA |
POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC |
SOLUTION;INTRAVENOUS |
1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML) |
Yes
|
Yes
|
2024/07/26
|
2024/07/26
|
AMNEAL |
Prescription |
| MIDAZOLAM IN 0.9% SODIUM CHLORIDE |
218993 |
001 |
ANDA |
MIDAZOLAM |
SOLUTION;INTRAVENOUS |
50MG/50ML (1MG/ML) |
No
|
No
|
2024/08/12
|
2024/08/12
|
GLAND |
Prescription |
| MIDAZOLAM IN 0.9% SODIUM CHLORIDE |
218993 |
002 |
ANDA |
MIDAZOLAM |
SOLUTION;INTRAVENOUS |
100MG/100ML (1MG/ML) |
No
|
No
|
2024/08/12
|
2024/08/12
|
GLAND |
Prescription |
| NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE |
215592 |
001 |
ANDA |
NICARDIPINE HYDROCHLORIDE |
INJECTABLE;INTRAVENOUS |
20MG/200ML (0.1MG/ML) |
No
|
No
|
2024/09/24
|
2024/09/24
|
CIPLA |
Prescription |
| NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE |
215592 |
002 |
ANDA |
NICARDIPINE HYDROCHLORIDE |
INJECTABLE;INTRAVENOUS |
40MG/200ML (0.2MG/ML) |
No
|
No
|
2024/09/24
|
2024/09/24
|
CIPLA |
Prescription |
| LEVETIRACETAM IN SODIUM CHLORIDE |
219562 |
001 |
ANDA |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
500MG/100ML (5MG/ML) |
No
|
No
|
2025/01/16
|
2025/01/16
|
CAPLIN |
Prescription |
| LEVETIRACETAM IN SODIUM CHLORIDE |
219562 |
002 |
ANDA |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
1GM/100ML (10MG/ML) |
No
|
No
|
2025/01/16
|
2025/01/16
|
CAPLIN |
Prescription |
| LEVETIRACETAM IN SODIUM CHLORIDE |
219562 |
003 |
ANDA |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
1.5GM/100ML (15MG/ML) |
No
|
No
|
2025/01/16
|
2025/01/16
|
CAPLIN |
Prescription |
| DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE |
218038 |
001 |
NDA |
DILTIAZEM HYDROCHLORIDE |
SOLUTION;INTRAVENOUS |
100MG/100ML (1MG/ML) |
Yes
|
Yes
|
2025/02/21
|
2025/02/21
|
HQ SPCLT PHARMA |
Prescription |
| DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE |
218038 |
002 |
NDA |
DILTIAZEM HYDROCHLORIDE |
SOLUTION;INTRAVENOUS |
250MG/250ML (1MG/ML) |
Yes
|
Yes
|
2025/02/21
|
2025/02/21
|
HQ SPCLT PHARMA |
Prescription |
| EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE |
218475 |
001 |
NDA |
EPINEPHRINE BITARTRATE |
SOLUTION;INTRAVENOUS |
EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) |
Yes
|
Yes
|
2025/02/28
|
2025/02/28
|
BAXTER HLTHCARE CORP |
Prescription |
| EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE |
218475 |
002 |
NDA |
EPINEPHRINE BITARTRATE |
SOLUTION;INTRAVENOUS |
EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) |
Yes
|
Yes
|
2025/02/28
|
2026/03/16
|
BAXTER HLTHCARE CORP |
Prescription |
| PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINER |
206056 |
001 |
NDA |
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM |
POWDER;INTRAVENOUS |
EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL |
Yes
|
Yes
|
2025/04/03
|
2025/04/03
|
B BRAUN MEDICAL |
Prescription |
| PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINER |
206056 |
002 |
NDA |
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM |
POWDER;INTRAVENOUS |
EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL |
Yes
|
Yes
|
2025/04/03
|
2025/04/03
|
B BRAUN MEDICAL |
Prescription |
| PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINER |
206056 |
003 |
NDA |
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM |
POWDER;INTRAVENOUS |
EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL |
Yes
|
Yes
|
2025/04/03
|
2025/04/03
|
B BRAUN MEDICAL |
Prescription |
| MIDAZOLAM IN 0.8% SODIUM CHLORIDE |
218454 |
001 |
ANDA |
MIDAZOLAM |
SOLUTION;INTRAVENOUS |
50MG/50ML (1MG/ML) |
No
|
Yes
|
2025/05/01
|
2025/05/01
|
B BRAUN MEDICAL |
Prescription |
| MIDAZOLAM IN 0.8% SODIUM CHLORIDE |
218454 |
002 |
ANDA |
MIDAZOLAM |
SOLUTION;INTRAVENOUS |
100MG/100ML (1MG/ML) |
No
|
Yes
|
2025/05/01
|
2025/05/01
|
B BRAUN MEDICAL |
Prescription |