| SODIUM CHLORIDE 14.6% |
212070 |
001 |
ANDA |
SODIUM CHLORIDE |
SOLUTION;INTRAVENOUS |
50MEQ/20ML (2.5MEQ/ML) |
No
|
No
|
2021/04/28
|
2021/04/28
|
FRESENIUS KABI USA |
Prescription |
| SODIUM CHLORIDE 14.6% |
212070 |
002 |
ANDA |
SODIUM CHLORIDE |
SOLUTION;INTRAVENOUS |
100MEQ/40ML (2.5MEQ/ML) |
No
|
No
|
2021/04/28
|
2021/04/28
|
FRESENIUS KABI USA |
Prescription |
| SODIUM CHLORIDE 23.4% |
212070 |
003 |
ANDA |
SODIUM CHLORIDE |
SOLUTION;INTRAVENOUS |
400MEQ/100ML (4MEQ/ML) |
No
|
No
|
2021/04/28
|
2022/02/14
|
FRESENIUS KABI USA |
Prescription |
| SODIUM CHLORIDE 23.4% |
212248 |
001 |
ANDA |
SODIUM CHLORIDE |
INJECTABLE;INJECTION |
234MG/ML |
No
|
No
|
2021/04/28
|
2021/04/28
|
FRESENIUS KABI USA |
Prescription |
| ARGATROBAN IN SODIUM CHLORIDE |
212035 |
001 |
NDA |
ARGATROBAN |
SOLUTION;INTRAVENOUS |
50MG/50ML (1MG/ML) |
Yes
|
Yes
|
2021/06/07
|
2021/06/07
|
ACCORD HLTHCARE |
Prescription |
| POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER |
212348 |
001 |
ANDA |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
INJECTABLE;INJECTION |
5GM/100ML;149MG/100ML;225MG/100ML |
No
|
No
|
2021/07/30
|
2021/07/30
|
FRESENIUS KABI USA |
Prescription |
| POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER |
212348 |
002 |
ANDA |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
INJECTABLE;INJECTION |
5GM/100ML;149MG/100ML;225MG/100ML |
No
|
No
|
2021/07/30
|
2021/07/30
|
FRESENIUS KABI USA |
Prescription |
| DAPTOMYCIN IN 0.9% SODIUM CHLORIDE |
213645 |
002 |
NDA |
DAPTOMYCIN |
SOLUTION;INTRAVENOUS |
350MG/50ML (7MG/ML) |
Yes
|
Yes
|
2022/01/25
|
2023/02/27
|
BAXTER HLTHCARE CORP |
Prescription |
| DAPTOMYCIN IN 0.9% SODIUM CHLORIDE |
213645 |
003 |
NDA |
DAPTOMYCIN |
SOLUTION;INTRAVENOUS |
500MG/50ML (10MG/ML) |
Yes
|
Yes
|
2022/01/25
|
2023/02/27
|
BAXTER HLTHCARE CORP |
Prescription |
| DAPTOMYCIN IN 0.9% SODIUM CHLORIDE |
213645 |
004 |
NDA |
DAPTOMYCIN |
SOLUTION;INTRAVENOUS |
700MG/100ML (7MG/ML) |
Yes
|
Yes
|
2022/01/25
|
2023/02/27
|
BAXTER HLTHCARE CORP |
Prescription |
| DAPTOMYCIN IN 0.9% SODIUM CHLORIDE |
213645 |
005 |
NDA |
DAPTOMYCIN |
SOLUTION;INTRAVENOUS |
1GM/100ML (10MG/ML) |
Yes
|
Yes
|
2022/01/25
|
2023/02/27
|
BAXTER HLTHCARE CORP |
Prescription |
| MIDAZOLAM IN 0.8% SODIUM CHLORIDE |
215868 |
001 |
NDA |
MIDAZOLAM |
SOLUTION;INTRAVENOUS |
50MG/50ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
Yes
|
No
|
2022/07/20
|
2022/07/20
|
EXELA PHARMA |
Discontinued |
| MIDAZOLAM IN 0.8% SODIUM CHLORIDE |
215868 |
002 |
NDA |
MIDAZOLAM |
SOLUTION;INTRAVENOUS |
100MG/100ML (1MG/ML) |
Yes
|
No
|
2022/07/20
|
2022/07/20
|
EXELA PHARMA |
Discontinued |
| NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE |
215700 |
001 |
NDA |
NOREPINEPHRINE BITARTRATE |
SOLUTION;INTRAVENOUS |
EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) |
Yes
|
Yes
|
2022/09/15
|
2022/09/15
|
INFORLIFE |
Prescription |
| NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE |
215700 |
002 |
NDA |
NOREPINEPHRINE BITARTRATE |
SOLUTION;INTRAVENOUS |
EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) |
Yes
|
Yes
|
2022/09/15
|
2022/09/15
|
INFORLIFE |
Prescription |
| 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 |
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 |
Discontinued |