| BIVALIRUDIN |
090811 |
001 |
ANDA |
BIVALIRUDIN |
INJECTABLE;INTRAVENOUS |
250MG/VIAL |
No
|
No
|
2015/07/14
|
2015/07/14
|
HOSPIRA |
Prescription |
| BIVALIRUDIN |
090816 |
001 |
ANDA |
BIVALIRUDIN |
INJECTABLE;INTRAVENOUS |
250MG/VIAL |
No
|
No
|
2015/07/14
|
2015/07/14
|
HOSPIRA |
Prescription |
| BIVALIRUDIN |
091206 |
001 |
ANDA |
BIVALIRUDIN |
INJECTABLE;INTRAVENOUS |
250MG/VIAL |
No
|
No
|
2016/09/14
(TA)
|
--
|
PLIVA HRVATSKA DOO |
None (Tentative Approval) |
| BIVALIRUDIN |
090189 |
001 |
ANDA |
BIVALIRUDIN |
INJECTABLE;INTRAVENOUS |
250MG/VIAL |
No
|
No
|
2016/10/28
|
2016/10/28
|
FRESENIUS KABI USA |
Prescription |
| BIVALIRUDIN |
091468 |
001 |
ANDA |
BIVALIRUDIN |
INJECTABLE;INJECTION |
250MG/VIAL |
No
|
No
|
2017/02/02
(TA)
|
--
|
MYLAN LABS LTD |
None (Tentative Approval) |
| BIVALIRUDIN |
201577 |
001 |
ANDA |
BIVALIRUDIN |
INJECTABLE;INTRAVENOUS |
250MG/VIAL |
No
|
No
|
2017/05/26
|
2017/05/26
|
DR REDDYS |
Prescription |
| BIVALIRUDIN |
204876 |
001 |
ANDA |
BIVALIRUDIN |
INJECTABLE;INTRAVENOUS |
250MG/VIAL |
No
|
No
|
2017/07/06
|
2017/07/06
|
APOTEX |
Discontinued |
| BIVALIRUDIN |
206551 |
001 |
ANDA |
BIVALIRUDIN |
INJECTABLE;INTRAVENOUS |
250MG/VIAL |
No
|
No
|
2017/11/22
|
2017/11/22
|
ACCORD HLTHCARE |
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 |
| BIVALIRUDIN |
202471 |
001 |
ANDA |
BIVALIRUDIN |
INJECTABLE;INTRAVENOUS |
250MG/VIAL |
No
|
No
|
2018/06/01
|
2018/06/01
|
MYLAN INSTITUTIONAL |
Prescription |
| BIVALIRUDIN |
091602 |
001 |
ANDA |
BIVALIRUDIN |
INJECTABLE;INTRAVENOUS |
250MG/VIAL |
No
|
No
|
2018/07/16
|
2018/07/16
|
MEITHEAL |
Prescription |
| BIVALIRUDIN |
205962 |
001 |
ANDA |
BIVALIRUDIN |
INJECTABLE;INTRAVENOUS |
250MG/VIAL |
No
|
No
|
2018/07/27
|
2018/07/27
|
EUGIA PHARMA |
Prescription |
| BIVALIRUDIN |
210031 |
001 |
ANDA |
BIVALIRUDIN |
INJECTABLE;INTRAVENOUS |
250MG/VIAL |
No
|
No
|
2019/10/23
|
2019/10/23
|
SHUANGCHENG |
Prescription |
| BIVALIRUDIN |
213078 |
001 |
ANDA |
BIVALIRUDIN |
INJECTABLE;INTRAVENOUS |
250MG/VIAL |
No
|
No
|
2021/05/28
|
2021/05/28
|
SLATE RUN PHARMA |
Prescription |