| SODIUM CHLORIDE 0.9% |
206171 |
002 |
ANDA |
SODIUM CHLORIDE |
SOLUTION;INJECTION |
90MG/10ML (9MG/ML) |
No
|
No
|
2017/07/21
|
2017/07/21
|
SPECTRA MDCL DEVICES |
Prescription |
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
207310 |
001 |
ANDA |
SODIUM CHLORIDE |
INJECTABLE;INJECTION |
900MG/100ML |
No
|
No
|
2017/09/19
|
2017/09/19
|
FRESENIUS KABI USA |
Prescription |
| LEVETIRACETAM IN SODIUM CHLORIDE |
206880 |
001 |
ANDA |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
500MG/100ML (5MG/ML) |
No
|
No
|
2017/10/25
|
2017/10/25
|
GLAND PHARMA LTD |
Prescription |
| LEVETIRACETAM IN SODIUM CHLORIDE |
206880 |
002 |
ANDA |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
1GM/100ML (10MG/ML) |
No
|
No
|
2017/10/25
|
2017/10/25
|
GLAND PHARMA LTD |
Prescription |
| LEVETIRACETAM IN SODIUM CHLORIDE |
206880 |
003 |
ANDA |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
1.5GM/100ML (15MG/ML) |
No
|
No
|
2017/10/25
|
2017/10/25
|
GLAND PHARMA LTD |
Prescription |
| BIVALIRUDIN IN 0.9% SODIUM CHLORIDE |
208374 |
001 |
NDA |
BIVALIRUDIN |
SOLUTION;INTRAVENOUS |
250MG/50ML (5MG/ML) |
Yes
|
No
|
2017/12/21
|
2017/12/21
|
BAXTER HLTHCARE CORP |
Discontinued |
| BIVALIRUDIN IN 0.9% SODIUM CHLORIDE |
208374 |
002 |
NDA |
BIVALIRUDIN |
SOLUTION;INTRAVENOUS |
500MG/100ML (5MG/ML) |
Yes
|
No
|
2017/12/21
|
2017/12/21
|
BAXTER HLTHCARE CORP |
Discontinued |
| SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER |
208122 |
001 |
ANDA |
SODIUM CHLORIDE |
INJECTABLE;INJECTION |
450MG/100ML |
No
|
No
|
2018/07/23
|
2018/07/23
|
FRESENIUS KABI USA |
Prescription |
| CALCIUM GLUCONATE IN SODIUM CHLORIDE |
210906 |
001 |
NDA |
CALCIUM GLUCONATE |
SOLUTION;INTRAVENOUS |
1GM/50ML (20MG/ML) |
Yes
|
Yes
|
2018/10/29
|
2018/10/29
|
HQ SPCLT PHARMA |
Prescription |
| CALCIUM GLUCONATE IN SODIUM CHLORIDE |
210906 |
002 |
NDA |
CALCIUM GLUCONATE |
SOLUTION;INTRAVENOUS |
2GM/100ML (20MG/ML) |
Yes
|
Yes
|
2018/10/29
|
2018/10/29
|
HQ SPCLT PHARMA |
Prescription |
| CALCIUM GLUCONATE IN SODIUM CHLORIDE |
210906 |
003 |
NDA |
CALCIUM GLUCONATE |
SOLUTION;INTRAVENOUS |
1GM/100ML (10MG/ML) |
Yes
|
Yes
|
2018/10/29
|
2021/06/04
|
HQ SPCLT PHARMA |
Prescription |
| ARGATROBAN IN SODIUM CHLORIDE |
209552 |
001 |
NDA |
ARGATROBAN |
SOLUTION;INTRAVENOUS |
50MG/50ML (1MG/ML) |
No
|
No
|
2018/11/27
|
2018/11/27
|
EUGIA PHARMA SPECLTS |
Prescription |
| SODIUM CHLORIDE 3% IN PLASTIC CONTAINER |
209476 |
001 |
ANDA |
SODIUM CHLORIDE |
INJECTABLE;INJECTION |
3GM/100ML |
No
|
No
|
2019/03/13
|
2019/03/13
|
FRESENIUS KABI USA |
Prescription |
| DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER |
211190 |
001 |
ANDA |
DEXTROSE; SODIUM CHLORIDE |
INJECTABLE;INJECTION |
2.5GM/100ML;450MG/100ML |
No
|
No
|
2019/12/20
|
2019/12/20
|
FRESENIUS KABI USA |
Prescription |
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
211968 |
001 |
ANDA |
SODIUM CHLORIDE |
SOLUTION;INJECTION |
450MG/50ML (9MG/ML) |
No
|
No
|
2020/04/23
|
2020/04/23
|
NEPHRON |
Prescription |
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
211968 |
002 |
ANDA |
SODIUM CHLORIDE |
SOLUTION;INJECTION |
900MG/100ML |
No
|
No
|
2020/04/23
|
2020/04/23
|
NEPHRON |
Prescription |
| LEVETIRACETAM IN SODIUM CHLORIDE |
213532 |
001 |
ANDA |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
500MG/100ML (5MG/ML) |
No
|
No
|
2020/07/06
|
2020/07/06
|
NEXUS |
Prescription |
| LEVETIRACETAM IN SODIUM CHLORIDE |
213532 |
002 |
ANDA |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
1GM/100ML (10MG/ML) |
No
|
No
|
2020/07/06
|
2020/07/06
|
NEXUS |
Prescription |
| LEVETIRACETAM IN SODIUM CHLORIDE |
213532 |
003 |
ANDA |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
1.5GM/100ML (15MG/ML) |
No
|
No
|
2020/07/06
|
2020/07/06
|
NEXUS |
Prescription |
| HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
212441 |
001 |
ANDA |
HEPARIN SODIUM |
INJECTABLE;INJECTION |
200 UNITS/100ML |
No
|
No
|
2020/07/24
|
2020/07/24
|
FRESENIUS KABI USA |
Prescription |