| EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE |
213926 |
001 |
ANDA |
EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE |
TABLET;ORAL |
200MG;EQ 25MG BASE |
No
|
No
|
2024/12/13
|
2024/12/13
|
LUPIN LTD |
Prescription |
| EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE |
208452 |
001 |
ANDA |
EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
200MG;EQ 25MG BASE;300MG |
No
|
No
|
2025/05/20
|
2025/05/20
|
MYLAN |
Prescription |
| BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE |
216914 |
002 |
ANDA |
BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE |
TABLET |
200MG |
No
|
No
|
2025/06/24
(TA)
|
--
|
CIPLA LTD |
None (Tentative Approval) |
| BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE |
216914 |
003 |
ANDA |
BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE |
TABLET |
25MG |
No
|
No
|
2025/06/24
(TA)
|
--
|
CIPLA LTD |
None (Tentative Approval) |
| BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE |
216914 |
004 |
ANDA |
BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE |
TABLET |
30MG |
No
|
No
|
2025/06/24
(TA)
|
--
|
CIPLA LTD |
None (Tentative Approval) |
| BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE |
216914 |
005 |
ANDA |
BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE |
TABLET |
120MG |
No
|
No
|
2025/06/24
(TA)
|
--
|
CIPLA LTD |
None (Tentative Approval) |
| BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE |
216914 |
006 |
ANDA |
BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE |
TABLET |
15MG |
No
|
No
|
2025/06/24
(TA)
|
--
|
CIPLA LTD |
None (Tentative Approval) |
| EMTRICITABINE AND TENOFOVIR ALAFENAMIDE |
211680 |
002 |
ANDA |
EMTRICITABINE, TENOFOVIR ALAFENAMIDE |
TABLET |
25MG |
No
|
No
|
2025/10/10
(TA)
|
--
|
CIPLA LIMITED |
None (Tentative Approval) |
| EMTRICITABINE AND TENOFOVIR ALAFENAMIDE |
211680 |
003 |
ANDA |
EMTRICITABINE, TENOFOVIR ALAFENAMIDE |
TABLET |
10MG |
No
|
No
|
2025/10/10
(TA)
|
--
|
CIPLA LIMITED |
None (Tentative Approval) |
| EMTRICITABINE AND TENOFOVIR ALAFENAMIDE |
211680 |
004 |
ANDA |
EMTRICITABINE, TENOFOVIR ALAFENAMIDE |
TABLET |
120MG |
No
|
No
|
2025/10/10
(TA)
|
--
|
CIPLA LIMITED |
None (Tentative Approval) |
| EMTRICITABINE AND TENOFOVIR ALAFENAMIDE |
211680 |
005 |
ANDA |
EMTRICITABINE, TENOFOVIR ALAFENAMIDE |
TABLET |
15MG |
No
|
No
|
2025/10/10
(TA)
|
--
|
CIPLA LIMITED |
None (Tentative Approval) |
| BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE |
218766 |
002 |
ANDA |
BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE |
TABLET |
200MG |
No
|
No
|
2025/10/14
(TA)
|
--
|
CIPLA LTD |
None (Tentative Approval) |
| BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE |
218766 |
003 |
ANDA |
BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE |
TABLET |
25MG |
No
|
No
|
2025/10/14
(TA)
|
--
|
CIPLA LTD |
None (Tentative Approval) |
| BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE |
218766 |
004 |
ANDA |
BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE |
TABLET |
30MG |
No
|
No
|
2025/10/14
(TA)
|
--
|
CIPLA LTD |
None (Tentative Approval) |
| BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE |
218766 |
005 |
ANDA |
BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE |
TABLET |
120MG |
No
|
No
|
2025/10/14
(TA)
|
--
|
CIPLA LTD |
None (Tentative Approval) |
| 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) |