| MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER |
202106 |
002 |
NDA |
MEROPENEM |
POWDER;INTRAVENOUS |
1GM/VIAL |
No
|
No
|
2015/04/30
|
2015/04/30
|
B BRAUN MEDICAL INC |
Prescription |
| LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
206473 |
001 |
NDA |
LINEZOLID |
SOLUTION;INTRAVENOUS |
600MG/300ML (2MG/ML) |
Yes
|
Yes
|
2015/06/18
|
2015/06/18
|
HOSPIRA |
Prescription |
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
203352 |
001 |
ANDA |
SODIUM CHLORIDE |
SOLUTION;INJECTION |
90MG/10ML (9MG/ML) |
No
|
No
|
2016/05/18
|
2016/05/18
|
JUBILANT CADISTA |
Discontinued |
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
203352 |
002 |
ANDA |
SODIUM CHLORIDE |
SOLUTION;INJECTION |
27MG/3ML (9MG/ML) |
No
|
No
|
2016/05/18
|
2016/05/18
|
JUBILANT CADISTA |
Discontinued |
| LEVETIRACETAM IN SODIUM CHLORIDE |
207160 |
001 |
ANDA |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
500MG/100ML (5MG/ML) |
No
|
No
|
2017/01/04
|
2017/01/04
|
EUGIA PHARMA |
Prescription |
| LEVETIRACETAM IN SODIUM CHLORIDE |
207160 |
002 |
ANDA |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
1GM/100ML (10MG/ML) |
No
|
No
|
2017/01/04
|
2017/01/04
|
EUGIA PHARMA |
Prescription |
| LEVETIRACETAM IN SODIUM CHLORIDE |
207160 |
003 |
ANDA |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
1.5GM/100ML (15MG/ML) |
No
|
No
|
2017/01/04
|
2017/01/04
|
EUGIA PHARMA |
Prescription |
| PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE |
202060 |
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
|
2017/03/08
|
2017/03/08
|
NOSTRUM LABS INC |
Discontinued |
| NIPRIDE RTU IN SODIUM CHLORIDE 0.9% |
209387 |
001 |
NDA |
SODIUM NITROPRUSSIDE |
SOLUTION;INTRAVENOUS |
50MG/100ML (0.5MG/ML) |
Yes
|
Yes
|
2017/03/08
|
2017/03/08
|
EXELA PHARMA |
Prescription |
| NIPRIDE RTU IN SODIUM CHLORIDE 0.9% |
209387 |
002 |
NDA |
SODIUM NITROPRUSSIDE |
SOLUTION;INTRAVENOUS |
10MG/50ML (0.2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
Yes
|
No
|
2017/03/08
|
2017/12/07
|
EXELA PHARMA |
Discontinued |
| NIPRIDE RTU IN SODIUM CHLORIDE 0.9% |
209387 |
003 |
NDA |
SODIUM NITROPRUSSIDE |
SOLUTION;INTRAVENOUS |
20MG/100ML (0.2MG/ML) |
Yes
|
Yes
|
2017/03/08
|
2018/07/13
|
EXELA PHARMA |
Prescription |
| CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE |
208083 |
001 |
NDA |
CLINDAMYCIN PHOSPHATE |
SOLUTION;INTRAVENOUS |
EQ 300MG BASE/50ML (EQ 6MG BASE/ML) |
Yes
|
Yes
|
2017/04/20
|
2017/04/20
|
BAXTER HLTHCARE CORP |
Prescription |
| CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE |
208083 |
002 |
NDA |
CLINDAMYCIN PHOSPHATE |
SOLUTION;INTRAVENOUS |
EQ 600MG BASE/50ML (EQ 12MG BASE/ML) |
Yes
|
Yes
|
2017/04/20
|
2017/04/20
|
BAXTER HLTHCARE CORP |
Prescription |
| CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE |
208083 |
003 |
NDA |
CLINDAMYCIN PHOSPHATE |
SOLUTION;INTRAVENOUS |
EQ 900MG BASE/50ML (EQ 18MG BASE/ML) |
Yes
|
Yes
|
2017/04/20
|
2017/04/20
|
BAXTER HLTHCARE CORP |
Prescription |
| MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER |
205833 |
001 |
ANDA |
MOXIFLOXACIN HYDROCHLORIDE |
SOLUTION;INTRAVENOUS |
400MG/250ML (1.6MG/ML) |
No
|
Yes
|
2017/05/05
|
2017/05/05
|
MYLAN LABS LTD |
Prescription |
| ARGATROBAN IN SODIUM CHLORIDE |
205570 |
001 |
ANDA |
ARGATROBAN |
INJECTABLE;INTRAVENOUS |
125MG/125ML (1MG/ML) |
No
|
No
|
2017/05/22
|
2017/05/22
|
GLAND PHARMA LTD |
Prescription |
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
207956 |
001 |
ANDA |
SODIUM CHLORIDE |
INJECTABLE;INJECTION |
900MG/100ML |
No
|
No
|
2017/05/25
|
2017/05/25
|
LABORATORIOS GRIFOLS |
Prescription |
| CALCIUM GLUCONATE IN SODIUM CHLORIDE |
208418 |
004 |
NDA |
CALCIUM GLUCONATE |
SOLUTION;INTRAVENOUS |
1GM/50ML (20MG/ML) |
Yes
|
Yes
|
2017/06/15
|
2021/06/17
|
FRESENIUS KABI USA |
Prescription |
| CALCIUM GLUCONATE IN SODIUM CHLORIDE |
208418 |
005 |
NDA |
CALCIUM GLUCONATE |
SOLUTION;INTRAVENOUS |
2GM/100ML (20MG/ML) |
Yes
|
Yes
|
2017/06/15
|
2021/06/17
|
FRESENIUS KABI USA |
Prescription |
| SODIUM CHLORIDE 0.9% |
206171 |
001 |
ANDA |
SODIUM CHLORIDE |
SOLUTION;INJECTION |
45MG/5ML (9MG/ML) |
No
|
No
|
2017/07/21
|
2017/07/21
|
SPECTRA MDCL DEVICES |
Prescription |