| LEVETIRACETAM IN SODIUM CHLORIDE |
202543 |
001 |
NDA |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
500MG/100ML (5MG/ML) |
Yes
|
Yes
|
2011/11/09
|
2011/11/09
|
HQ SPCLT PHARMA |
Prescription |
| LEVETIRACETAM IN SODIUM CHLORIDE |
202543 |
002 |
NDA |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
1GM/100ML (10MG/ML) |
Yes
|
Yes
|
2011/11/09
|
2011/11/09
|
HQ SPCLT PHARMA |
Prescription |
| LEVETIRACETAM IN SODIUM CHLORIDE |
202543 |
003 |
NDA |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
1.5GM/100ML (15MG/ML) |
Yes
|
Yes
|
2011/11/09
|
2011/11/09
|
HQ SPCLT PHARMA |
Prescription |
| LEVETIRACETAM IN SODIUM CHLORIDE |
202543 |
004 |
NDA |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
250MG/50ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
Yes
|
No
|
2011/11/09
|
2020/12/14
|
HQ SPCLT PHARMA |
Discontinued |
| SODIUM CHLORIDE 0.9% |
202832 |
001 |
NDA |
SODIUM CHLORIDE |
INJECTABLE;INJECTION |
9MG/ML (9MG/ML) |
Yes
|
No
|
2012/01/06
|
2012/01/06
|
MEDEFIL INC |
Discontinued |
| SODIUM CHLORIDE 0.9% |
202832 |
002 |
NDA |
SODIUM CHLORIDE |
INJECTABLE;INJECTION |
18MG/2ML (9MG/ML) |
Yes
|
No
|
2012/01/06
|
2012/01/06
|
MEDEFIL INC |
Discontinued |
| SODIUM CHLORIDE 0.9% |
202832 |
003 |
NDA |
SODIUM CHLORIDE |
INJECTABLE;INJECTION |
22.5MG/2.5ML (9MG/ML) |
Yes
|
No
|
2012/01/06
|
2012/01/06
|
MEDEFIL INC |
Discontinued |
| SODIUM CHLORIDE 0.9% |
202832 |
004 |
NDA |
SODIUM CHLORIDE |
INJECTABLE;INJECTION |
27MG/3ML (9MG/ML) |
Yes
|
No
|
2012/01/06
|
2012/01/06
|
MEDEFIL INC |
Discontinued |
| SODIUM CHLORIDE 0.9% |
202832 |
005 |
NDA |
SODIUM CHLORIDE |
INJECTABLE;INJECTION |
45MG/5ML (9MG/ML) |
Yes
|
No
|
2012/01/06
|
2012/01/06
|
MEDEFIL INC |
Discontinued |
| SODIUM CHLORIDE 0.9% |
202832 |
006 |
NDA |
SODIUM CHLORIDE |
INJECTABLE;INJECTION |
90MG/10ML (9MG/ML) |
Yes
|
Yes
|
2012/01/06
|
2012/01/06
|
MEDEFIL INC |
Prescription |
| SODIUM CHLORIDE 0.9% |
201850 |
001 |
ANDA |
SODIUM CHLORIDE |
SOLUTION;INJECTION |
90MG/10ML (9MG/ML) |
No
|
No
|
2012/01/20
|
2012/01/20
|
HIKMA |
Discontinued |
| PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID |
090145 |
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
|
2012/01/25
|
2012/01/25
|
NOVEL LABS INC |
Prescription |
| FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
078698 |
001 |
ANDA |
FLUCONAZOLE |
INJECTABLE;INJECTION |
200MG/100ML (2MG/ML) |
No
|
No
|
2012/01/30
|
2012/01/30
|
HIKMA FARMACEUTICA |
Prescription |
| FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
078698 |
002 |
ANDA |
FLUCONAZOLE |
INJECTABLE;INJECTION |
400MG/200ML (2MG/ML) |
No
|
No
|
2012/01/30
|
2012/01/30
|
HIKMA FARMACEUTICA |
Prescription |
| SODIUM CHLORIDE 0.9% |
201833 |
001 |
ANDA |
SODIUM CHLORIDE |
SOLUTION;INJECTION |
18MG/2ML (9MG/ML) |
No
|
No
|
2013/09/24
|
2013/09/24
|
HIKMA |
Prescription |
| SODIUM CHLORIDE 0.9% |
201833 |
002 |
ANDA |
SODIUM CHLORIDE |
SOLUTION;INJECTION |
90MG/10ML (9MG/ML) |
No
|
No
|
2013/09/24
|
2015/01/07
|
HIKMA |
Prescription |
| PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL |
202217 |
001 |
ANDA |
BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
FOR SOLUTION, TABLET, DELAYED RELEASE;ORAL |
5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM |
No
|
No
|
2014/08/20
|
2014/08/20
|
NOVEL LABS INC |
Discontinued |
| ARGATROBAN IN 0.9% SODIUM CHLORIDE |
206769 |
001 |
NDA |
ARGATROBAN |
INJECTABLE;INTRAVENOUS |
250MG/250ML (1MG/ML) |
No
|
No
|
2014/12/15
|
2014/12/15
|
TEVA PHARMS USA |
Discontinued |
| PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE |
204559 |
001 |
ANDA |
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
FOR SOLUTION;ORAL |
420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT |
No
|
No
|
2015/04/13
|
2015/04/13
|
STRIDES PHARMA |
Prescription |
| MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER |
202106 |
001 |
NDA |
MEROPENEM |
POWDER;INTRAVENOUS |
500MG/VIAL |
No
|
No
|
2015/04/30
|
2015/04/30
|
B BRAUN MEDICAL INC |
Prescription |