| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
077407 |
001 |
ANDA |
SODIUM CHLORIDE |
SOLUTION;INJECTION |
45MG/5ML (9MG/ML) |
No
|
Yes
|
2006/08/11
|
2006/08/11
|
TARO |
Prescription |
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
077407 |
002 |
ANDA |
SODIUM CHLORIDE |
SOLUTION;INJECTION |
90MG/10ML (9MG/ML) |
No
|
Yes
|
2006/08/11
|
2006/08/11
|
TARO |
Prescription |
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
078177 |
001 |
ANDA |
SODIUM CHLORIDE |
INJECTABLE;INJECTION |
900MG/100ML |
No
|
No
|
2007/04/12
|
2007/04/12
|
FRESENIUS MEDCL |
Prescription |
| NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE |
022276 |
002 |
NDA |
NICARDIPINE HYDROCHLORIDE |
INJECTABLE;INTRAVENOUS |
20MG/200ML (0.1MG/ML) |
Yes
|
Yes
|
2008/07/24
|
2016/04/07
|
HIKMA INTL PHARMS |
Prescription |
| NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE |
022276 |
003 |
NDA |
NICARDIPINE HYDROCHLORIDE |
INJECTABLE;INTRAVENOUS |
40MG/200ML (0.2MG/ML) |
Yes
|
Yes
|
2008/07/24
|
2016/04/07
|
HIKMA INTL PHARMS |
Prescription |
| FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
078107 |
001 |
ANDA |
FLUCONAZOLE |
INJECTABLE;INJECTION |
200MG/100ML (2MG/ML) |
No
|
No
|
2008/07/30
|
2008/07/30
|
WEST-WARD PHARMS INT |
Prescription |
| FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
078107 |
002 |
ANDA |
FLUCONAZOLE |
INJECTABLE;INJECTION |
400MG/200ML (2MG/ML) |
No
|
No
|
2008/07/30
|
2008/07/30
|
WEST-WARD PHARMS INT |
Prescription |
| POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER |
078446 |
001 |
ANDA |
POTASSIUM CHLORIDE; SODIUM CHLORIDE |
INJECTABLE;INJECTION |
149MG/100ML;450MG/100ML |
No
|
No
|
2008/09/10
|
2008/09/10
|
ICU MEDICAL INC |
Prescription |
| PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE |
090019 |
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
|
2009/05/27
|
2009/05/27
|
NOVEL LABS INC |
Prescription |
| FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
079104 |
001 |
ANDA |
FLUCONAZOLE |
INJECTABLE;INJECTION |
200MG/100ML (2MG/ML) |
No
|
Yes
|
2009/07/30
|
2009/07/30
|
INFORLIFE |
Prescription |
| FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
079104 |
002 |
ANDA |
FLUCONAZOLE |
INJECTABLE;INJECTION |
400MG/200ML (2MG/ML) |
No
|
Yes
|
2009/07/30
|
2009/07/30
|
INFORLIFE |
Prescription |
| PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE |
090409 |
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
|
2010/04/02
|
2010/04/02
|
EXTROVIS |
Discontinued |
| FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
077909 |
001 |
ANDA |
FLUCONAZOLE |
INJECTABLE;INJECTION |
200MG/100ML (2MG/ML) |
No
|
No
|
2010/05/26
|
2010/05/26
|
WOODWARD |
Prescription |
| FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
077909 |
002 |
ANDA |
FLUCONAZOLE |
INJECTABLE;INJECTION |
400MG/200ML (2MG/ML) |
No
|
No
|
2010/05/26
|
2010/05/26
|
WOODWARD |
Prescription |
| FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
077909 |
003 |
ANDA |
FLUCONAZOLE |
INJECTABLE;INJECTION |
100MG/50ML (2MG/ML) |
No
|
No
|
2010/05/26
|
2015/04/20
|
WOODWARD |
Prescription |
| FLUCONAZOLE IN SODIUM CHLORIDE 0.9% |
077947 |
001 |
ANDA |
FLUCONAZOLE |
INJECTABLE;INJECTION |
200MG/100ML (2MG/ML) |
No
|
No
|
2010/05/26
|
2010/05/26
|
BAXTER HLTHCARE CORP |
Discontinued |
| FLUCONAZOLE IN SODIUM CHLORIDE 0.9% |
077947 |
002 |
ANDA |
FLUCONAZOLE |
INJECTABLE;INJECTION |
400MG/200ML (2MG/ML) |
No
|
No
|
2010/05/26
|
2010/05/26
|
BAXTER HLTHCARE CORP |
Discontinued |
| POLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE; BISACODYL |
090197 |
001 |
ANDA |
POLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE; BISACODYL |
SOLUTION; ORAL AND TABLET; DELAYED RELEASE |
2MG; 5MG |
No
|
No
|
2010/05/27
(TA)
|
--
|
NOVEL LABS INC |
None (Tentative Approval) |
| ARGATROBAN IN SODIUM CHLORIDE |
022485 |
001 |
NDA |
ARGATROBAN |
INJECTABLE;INTRAVENOUS |
125MG/125ML (1MG/ML) |
Yes
|
Yes
|
2011/05/09
|
2011/05/09
|
SANDOZ |
Prescription |
| ARGATROBAN IN SODIUM CHLORIDE |
022434 |
001 |
NDA |
ARGATROBAN |
INJECTABLE;INTRAVENOUS |
50MG/50ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
Yes
|
No
|
2011/06/29
|
2011/06/29
|
CIPLA |
Discontinued |