| ARGATROBAN |
020883 |
001 |
NDA |
ARGATROBAN |
INJECTABLE;INJECTION |
250MG/2.5ML (100MG/ML) |
Yes
|
No
|
2000/06/30
|
2000/06/30
|
SANDOZ |
Discontinued |
| ARGATROBAN |
022359 |
001 |
NDA |
ARGATROBAN |
INJECTABLE; INJECTION |
250MG/250ML |
No
|
No
|
2010/07/28
(TA)
|
--
|
BAXTER HLTHCARE CORP |
None (Tentative Approval) |
| ARGATROBAN |
079238 |
001 |
ANDA |
ARGATROBAN |
INJECTABLE; INJECTION |
100MG |
No
|
No
|
2010/12/29
(TA)
|
--
|
PLIVA HRVATSKA DOO |
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 DEXTROSE |
201743 |
001 |
NDA |
ARGATROBAN |
SOLUTION;INTRAVENOUS |
125MG/125ML (1MG/ML) |
No
|
No
|
2011/05/09
|
2011/05/09
|
SANDOZ |
Discontinued |
| 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50MG/50ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |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 |
| ARGATROBAN |
203049 |
001 |
NDA |
ARGATROBAN |
INJECTABLE;INJECTION |
250MG/2.5ML (100MG/ML) |
Yes
|
Yes
|
2012/01/05
|
2012/01/05
|
HIKMA PHARM CO LTD |
Prescription |
| ARGATROBAN |
203049 |
002 |
NDA |
ARGATROBAN |
INJECTABLE;INJECTION |
50MG/50ML (1MG/ML) |
Yes
|
Yes
|
2012/01/05
|
2016/09/30
|
HIKMA PHARM CO LTD |
Prescription |
| ARGATROBAN |
091665 |
001 |
ANDA |
ARGATROBAN |
INJECTABLE;INJECTION |
250MG/2.5ML (100MG/ML) |
No
|
No
|
2014/06/30
|
2014/06/30
|
ENDO OPERATIONS |
Prescription |
| ARGATROBAN |
202626 |
001 |
ANDA |
ARGATROBAN |
INJECTABLE;INJECTION |
250MG/2.5ML (100MG/ML) |
No
|
No
|
2014/06/30
|
2014/06/30
|
MYLAN INSTITUTIONAL |
Prescription |
| 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 |
| ARGATROBAN |
201811 |
001 |
NDA |
ARGATROBAN |
INJECTABLE;INJECTION |
250MG/2.5ML (100MG/ML) |
No
|
No
|
2015/03/23
|
2015/03/23
|
FRESENIUS KABI USA |
Prescription |
| ARGATROBAN |
204120 |
001 |
ANDA |
ARGATROBAN |
INJECTABLE;INJECTION |
250MG/2.5ML (100MG/ML) |
No
|
Yes
|
2016/09/21
|
2016/09/21
|
HOSPIRA |
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 |
| ARGATROBAN |
206698 |
001 |
ANDA |
ARGATROBAN |
INJECTABLE;INJECTION |
250MG/2.5ML (100MG/ML) |
No
|
No
|
2018/01/26
|
2018/01/26
|
AMNEAL PHARMS CO |
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 |
| ARGATROBAN |
214235 |
001 |
ANDA |
ARGATROBAN |
INJECTABLE;INJECTION |
50MG/50ML (1MG/ML) |
No
|
No
|
2021/01/21
|
2021/01/21
|
CAPLIN |
Prescription |
| ARGATROBAN IN SODIUM CHLORIDE |
212035 |
001 |
NDA |
ARGATROBAN |
SOLUTION;INTRAVENOUS |
50MG/50ML (1MG/ML) |
Yes
|
Yes
|
2021/06/07
|
2021/06/07
|
ACCORD HLTHCARE |
Prescription |
| ARGATROBAN |
217848 |
001 |
ANDA |
ARGATROBAN |
INJECTABLE;INJECTION |
50MG/50ML (1MG/ML) |
No
|
No
|
2023/07/31
|
2023/07/31
|
GLAND PHARMA LTD |
Prescription |