| VARENICLINE |
201920 |
001 |
ANDA |
VARENICLINE |
TABLET; ORAL |
0.5MG |
No
|
No
|
2013/09/10
(TA)
|
--
|
TEVA PHARMS USA |
None (Tentative Approval) |
| VARENICLINE |
201920 |
002 |
ANDA |
VARENICLINE |
TABLET; ORAL |
1MG |
No
|
No
|
2013/09/10
(TA)
|
--
|
TEVA PHARMS USA |
None (Tentative Approval) |
| VARENICLINE TARTRATE |
201808 |
001 |
ANDA |
VARENICLINE TARTRATE |
TABLET;ORAL |
EQ 0.5MG BASE |
No
|
No
|
2016/12/15
(TA)
|
--
|
WATSON LABS INC |
None (Tentative Approval) |
| VARENICLINE TARTRATE |
201808 |
002 |
ANDA |
VARENICLINE TARTRATE |
TABLET;ORAL |
EQ 1MG BASE |
No
|
No
|
2016/12/15
(TA)
|
--
|
WATSON LABS INC |
None (Tentative Approval) |
| VARENICLINE TARTRATE |
201785 |
001 |
ANDA |
VARENICLINE TARTRATE |
TABLET;ORAL |
EQ 0.5MG BASE |
No
|
No
|
2021/08/11
|
2021/08/11
|
PAR PHARM INC |
Prescription |
| VARENICLINE TARTRATE |
201785 |
002 |
ANDA |
VARENICLINE TARTRATE |
TABLET;ORAL |
EQ 1MG BASE |
No
|
Yes
|
2021/08/11
|
2021/08/11
|
PAR PHARM INC |
Prescription |
| VARENICLINE TARTRATE |
201962 |
001 |
ANDA |
VARENICLINE TARTRATE |
TABLET;ORAL |
EQ 0.5MG BASE |
No
|
No
|
2023/01/25
|
2023/01/25
|
APOTEX |
Prescription |
| VARENICLINE TARTRATE |
201962 |
002 |
ANDA |
VARENICLINE TARTRATE |
TABLET;ORAL |
EQ 1MG BASE |
No
|
No
|
2023/01/25
|
2023/01/25
|
APOTEX |
Prescription |
| VARENICLINE TARTRATE |
216723 |
001 |
ANDA |
VARENICLINE TARTRATE |
TABLET;ORAL |
EQ 0.5MG BASE |
No
|
No
|
2023/06/12
|
2023/06/12
|
ZYDUS |
Prescription |
| VARENICLINE TARTRATE |
216723 |
002 |
ANDA |
VARENICLINE TARTRATE |
TABLET;ORAL |
EQ 1MG BASE |
No
|
No
|
2023/06/12
|
2023/06/12
|
ZYDUS |
Prescription |
| VARENICLINE TARTRATE |
217151 |
001 |
ANDA |
VARENICLINE TARTRATE |
TABLET;ORAL |
EQ 0.5MG BASE |
No
|
No
|
2023/07/25
|
2023/07/25
|
LEADING PHARMA |
Prescription |
| VARENICLINE TARTRATE |
217151 |
002 |
ANDA |
VARENICLINE TARTRATE |
TABLET;ORAL |
EQ 1MG BASE |
No
|
No
|
2023/07/25
|
2023/07/25
|
LEADING PHARMA |
Prescription |
| VARENICLINE TARTRATE |
214255 |
001 |
ANDA |
VARENICLINE TARTRATE |
TABLET;ORAL |
EQ 0.5MG BASE |
No
|
No
|
2023/08/01
|
2023/08/01
|
MANKIND PHARMA |
Prescription |
| VARENICLINE TARTRATE |
214255 |
002 |
ANDA |
VARENICLINE TARTRATE |
TABLET;ORAL |
EQ 1MG BASE |
No
|
No
|
2023/08/01
|
2023/08/01
|
MANKIND PHARMA |
Prescription |
| VARENICLINE TARTRATE |
214557 |
001 |
ANDA |
VARENICLINE TARTRATE |
TABLET;ORAL |
EQ 0.5MG BASE |
No
|
No
|
2023/08/23
|
2023/08/23
|
ALKEM LABS LTD |
Prescription |
| VARENICLINE TARTRATE |
214557 |
002 |
ANDA |
VARENICLINE TARTRATE |
TABLET;ORAL |
EQ 1MG BASE |
No
|
No
|
2023/08/23
|
2023/08/23
|
ALKEM LABS LTD |
Prescription |
| VARENICLINE TARTRATE |
214571 |
001 |
ANDA |
VARENICLINE TARTRATE |
TABLET;ORAL |
EQ 0.5MG BASE |
No
|
No
|
2023/10/23
|
2023/10/23
|
HETERO LABS LTD III |
Prescription |
| VARENICLINE TARTRATE |
214571 |
002 |
ANDA |
VARENICLINE TARTRATE |
TABLET;ORAL |
EQ 1MG BASE |
No
|
No
|
2023/10/23
|
2023/10/23
|
HETERO LABS LTD III |
Prescription |
| VARENICLINE TARTRATE |
211862 |
001 |
ANDA |
VARENICLINE TARTRATE |
TABLET;ORAL |
EQ 0.5MG BASE |
No
|
No
|
2023/12/04
|
2023/12/04
|
LUPIN LTD |
Prescription |
| VARENICLINE TARTRATE |
211862 |
002 |
ANDA |
VARENICLINE TARTRATE |
TABLET;ORAL |
EQ 1MG BASE |
No
|
No
|
2023/12/04
|
2023/12/04
|
LUPIN LTD |
Prescription |