| EPINEPHRINE |
219239 |
002 |
ANDA |
EPINEPHRINE |
SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS |
30MG/30ML (1MG/ML) |
No
|
No
|
2025/02/06
|
2025/10/02
|
GLAND |
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 |
215425 |
001 |
NDA |
EPINEPHRINE |
SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS |
30MG/30ML (1MG/ML) |
Yes
|
Yes
|
2025/03/13
|
2025/03/13
|
FRESENIUS KABI USA |
Prescription |
| NOREPINEPHRINE BITARTRATE |
219443 |
001 |
ANDA |
NOREPINEPHRINE BITARTRATE |
INJECTABLE;INJECTION |
EQ 1MG BASE/ML |
No
|
No
|
2025/03/21
|
2025/03/21
|
BIOCON PHARMA |
Prescription |
| EPINEPHRINE |
218144 |
001 |
ANDA |
EPINEPHRINE |
SOLUTION;INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS |
1MG/ML (1MG/ML) |
No
|
No
|
2025/06/03
|
2025/06/03
|
GLAND |
Prescription |
| EPINEPHRINE |
218144 |
002 |
ANDA |
EPINEPHRINE |
INJECTION;SOLUTION,CONCENTRATE |
10MG/10ML |
No
|
No
|
2025/06/03
|
--
|
GLAND |
None (Tentative Approval) |
| EPINEPHRINE |
218144 |
003 |
ANDA |
EPINEPHRINE |
INJECTION;SOLUTION,CONCENTRATE |
30MG/30ML |
No
|
No
|
2025/06/03
|
--
|
GLAND |
None (Tentative Approval) |
| NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE |
219692 |
001 |
ANDA |
NOREPINEPHRINE BITARTRATE |
SOLUTION;INTRAVENOUS |
EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) |
No
|
No
|
2025/08/11
|
2025/08/11
|
SAGENT |
Prescription |
| NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE |
219692 |
002 |
ANDA |
NOREPINEPHRINE BITARTRATE |
SOLUTION;INTRAVENOUS |
EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) |
No
|
No
|
2025/08/11
|
2025/08/11
|
SAGENT |
Prescription |
| EPINEPHRINE |
217485 |
001 |
ANDA |
EPINEPHRINE |
SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS |
EQ 30MG BASE/30ML (EQ 1MG BASE/ML) |
No
|
No
|
2025/10/14
|
2025/10/14
|
AMNEAL |
Prescription |
| NOREPINEPHRINE BITARTRATE |
219924 |
001 |
ANDA |
NOREPINEPHRINE BITARTRATE |
INJECTABLE;INJECTION |
EQ 1MG BASE/ML |
No
|
No
|
2025/11/25
|
--
|
ANTHEA PHARMA |
Prescription |