| PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE |
217512 |
001 |
NDA |
PANTOPRAZOLE SODIUM |
SOLUTION;INTRAVENOUS |
EQ 40MG BASE/100ML (EQ 0.4MG BASE/ML) |
Yes
|
Yes
|
2024/02/14
|
2024/02/14
|
BAXTER HLTHCARE CORP |
Prescription |
| PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE |
217512 |
002 |
NDA |
PANTOPRAZOLE SODIUM |
SOLUTION;INTRAVENOUS |
EQ 40MG BASE/50ML (EQ 0.8MG BASE/ML) |
Yes
|
Yes
|
2024/02/14
|
2024/02/14
|
BAXTER HLTHCARE CORP |
Prescription |
| PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE |
217512 |
003 |
NDA |
PANTOPRAZOLE SODIUM |
SOLUTION;INTRAVENOUS |
EQ 80MG BASE/100ML (EQ 0.8MG BASE/ML) |
Yes
|
Yes
|
2024/02/14
|
2024/02/14
|
BAXTER HLTHCARE CORP |
Prescription |
| LEVETIRACETAM IN SODIUM CHLORIDE |
209705 |
001 |
ANDA |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
500MG/100ML (5MG/ML) |
No
|
No
|
2024/02/27
|
2024/02/27
|
B BRAUN MEDICAL INC |
Prescription |
| LEVETIRACETAM IN SODIUM CHLORIDE |
209705 |
002 |
ANDA |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
1GM/100ML (10MG/ML) |
No
|
No
|
2024/02/27
|
2024/02/27
|
B BRAUN MEDICAL INC |
Prescription |
| LEVETIRACETAM IN SODIUM CHLORIDE |
209705 |
003 |
ANDA |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
1.5GM/100ML (15MG/ML) |
No
|
No
|
2024/02/27
|
2024/02/27
|
B BRAUN MEDICAL INC |
Prescription |
| NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE |
203978 |
001 |
ANDA |
NICARDIPINE HYDROCHLORIDE |
INJECTABLE;INTRAVENOUS |
20MG/200ML (0.1MG/ML) |
No
|
No
|
2024/04/17
|
2024/04/17
|
INFORLIFE |
Prescription |
| NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE |
203978 |
002 |
ANDA |
NICARDIPINE HYDROCHLORIDE |
INJECTABLE;INTRAVENOUS |
40MG/200ML (0.2MG/ML) |
No
|
No
|
2024/04/17
|
2024/04/17
|
INFORLIFE |
Prescription |
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
213688 |
001 |
ANDA |
SODIUM CHLORIDE |
SOLUTION;IRRIGATION |
900MG/100ML |
No
|
No
|
2024/06/24
|
2024/06/24
|
FRESENIUS KABI USA |
Prescription |
| PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID |
207498 |
001 |
ANDA |
ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE |
FOR SOLUTION;ORAL |
4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM |
No
|
No
|
2024/06/28
|
2024/06/28
|
TARO |
Prescription |
| 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
|
Yes
|
2024/07/11
|
2024/07/11
|
LONG GROVE PHARMS |
Prescription |
| 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 PHARMA LTD |
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 PHARMA LTD |
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 |