| BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE |
218766 |
006 |
ANDA |
BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE |
TABLET |
15MG |
No
|
No
|
2025/10/14
(TA)
|
--
|
CIPLA LTD |
None (Tentative Approval) |
| 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) |
| EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE |
214216 |
001 |
ANDA |
EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE |
TABLET;ORAL |
200MG;EQ 25MG BASE |
No
|
No
|
2026/04/07
|
2026/04/07
|
MACLEODS PHARMS LTD |
Prescription |