| 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 |
| 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 |
| PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE |
216830 |
001 |
NDA |
PHENYLEPHRINE HYDROCHLORIDE |
SOLUTION;INTRAVENOUS |
20MG/250ML (0.08MG/ML) |
Yes
|
Yes
|
2025/05/30
|
2025/05/30
|
DR REDDYS LABS SA |
Prescription |
| NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE |
220243 |
001 |
ANDA |
NICARDIPINE HYDROCHLORIDE |
INJECTABLE;INTRAVENOUS |
20MG/200ML (0.1MG/ML) |
No
|
No
|
2025/10/22
|
2025/10/22
|
CAPLIN |
Prescription |
| NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE |
220243 |
002 |
ANDA |
NICARDIPINE HYDROCHLORIDE |
INJECTABLE;INTRAVENOUS |
40MG/200ML (0.2MG/ML) |
No
|
No
|
2025/10/22
|
2025/10/22
|
CAPLIN |
Prescription |