| COBICISTAT |
209986 |
001 |
ANDA |
COBICISTAT |
TABLET;ORAL |
150MG |
No
|
No
|
2024/02/07
|
2024/02/07
|
MYLAN LABS LTD |
Discontinued |
| ELVITEGRAVIR, COBICISTAT, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE |
218575 |
002 |
ANDA |
ELVITEGRAVIR, COBICISTAT, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE |
TABLET |
150MG |
No
|
No
|
2026/02/09
(TA)
|
--
|
APOTEX INC |
None (Tentative Approval) |
| ELVITEGRAVIR, COBICISTAT, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE |
218575 |
003 |
ANDA |
ELVITEGRAVIR, COBICISTAT, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE |
TABLET |
200MG |
No
|
No
|
2026/02/09
(TA)
|
--
|
APOTEX INC |
None (Tentative Approval) |
| ELVITEGRAVIR, COBICISTAT, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE |
218575 |
004 |
ANDA |
ELVITEGRAVIR, COBICISTAT, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE |
TABLET |
6MG |
No
|
No
|
2026/02/09
(TA)
|
--
|
APOTEX INC |
None (Tentative Approval) |
| ELVITEGRAVIR, COBICISTAT, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE |
218575 |
005 |
ANDA |
ELVITEGRAVIR, COBICISTAT, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE |
TABLET |
90MG |
No
|
No
|
2026/02/09
(TA)
|
--
|
APOTEX INC |
None (Tentative Approval) |
| ELVITEGRAVIR, COBICISTAT, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE |
218575 |
006 |
ANDA |
ELVITEGRAVIR, COBICISTAT, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE |
TABLET |
120MG |
No
|
No
|
2026/02/09
(TA)
|
--
|
APOTEX INC |
None (Tentative Approval) |