| TENOFOVIR ALAFENAMIDE |
213845 |
001 |
ANDA |
TENOFOVIR ALAFENAMIDE |
TABLET;ORAL |
25MG |
No
|
No
|
2021/07/08
(TA)
|
--
|
SUNSHINE LAKE |
None (Tentative Approval) |
| DOLUTEGRAVIR LAMIVUDINE TENOFOVIR ALAFENAMIDE |
212527 |
001 |
NDA |
DOLUTEGRAVIR LAMIVUDINE TENOFOVIR ALAFENAMIDE |
TABLET, FOR SUSPENSION; ORAL |
EQ 50MG BASE; 300MG; 25MG |
No
|
No
|
2022/03/30
(TA)
|
--
|
CIPLA USA INC. |
None (Tentative Approval) |
| TENOFOVIR ALAFENAMIDE |
214072 |
001 |
ANDA |
TENOFOVIR ALAFENAMIDE |
TABLET;ORAL |
25MG |
No
|
No
|
2022/09/15
(TA)
|
--
|
SHILPA MEDICARE LTD |
None (Tentative Approval) |
| EMTRICITABINE; RILPIVIRINE; TENOFOVIR ALAFENAMIDE |
214058 |
001 |
ANDA |
EMTRICITABINE;RILPIVIRINE;TENOFOVIR ALAFENAMIDE |
TABLET;ORAL |
200MG;25MG;25MG |
No
|
No
|
2022/09/27
(TA)
|
--
|
CIPLA LIMITED |
None (Tentative Approval) |
| EMTRICITABINE; TENOFOVIR ALAFENAMIDE |
216875 |
001 |
ANDA |
EMTRICITABINE;TENOFOVIR ALAFENAMIDE |
TABLET;ORAL |
200MG/25MG |
No
|
No
|
2022/12/19
(TA)
|
--
|
AUROBINDO PHARMA |
None (Tentative Approval) |
| DOLUTEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE |
214544 |
001 |
NDA |
DOLUTEGRAVIR;EMTRICITABINE;TENOFOVIR ALAFENAMIDE |
TABLET;ORAL |
50MG;200MG;25MG |
No
|
No
|
2023/01/19
(TA)
|
--
|
LUPIN LTD |
None (Tentative Approval) |
| TENOFOVIR ALAFENAMIDE |
214226 |
001 |
ANDA |
TENOFOVIR ALAFENAMIDE FUMARATE |
TABLET;ORAL |
EQ 25MG BASE |
No
|
No
|
2023/03/30
|
2023/03/30
|
LUPIN LTD |
Prescription |
| DOLUTEGRAVIR, EMTRICITABINE and TENOFOVIR ALAFENAMIDE |
215448 |
001 |
NDA |
DOLUTEGRAVIR, EMTRICITABINE and TENOFOVIR ALAFENAMIDE |
TABLET; ORAL |
50MG/200MG/25MG |
No
|
No
|
2023/05/26
(TA)
|
--
|
AUROBINDO PHARMA USA |
None (Tentative Approval) |
| DOLUTEGRAVIR;LAMIVUDINE;TENOFOVIR ALAFENAMIDE |
215187 |
001 |
NDA |
DOLUTEGRAVIR;LAMIVUDINE;TENOFOVIR ALAFENAMIDE |
TABLET; ORAL |
50MG;300MG;25MG |
No
|
No
|
2023/07/18
(TA)
|
--
|
LUPIN PHARMS |
None (Tentative Approval) |
| TENOFOVIR ALAFENAMIDE FUMARATE |
214030 |
001 |
ANDA |
TENOFOVIR ALAFENAMIDE FUMARATE |
TABLET;ORAL |
EQ 25MG BASE |
No
|
No
|
2023/09/22
(TA)
|
--
|
LAURUS LABS LTD |
None (Tentative Approval) |
| EMTRICITABINE AND TENOFOVIR ALAFENAMIDE |
211148 |
001 |
ANDA |
EMTRICITABINE, TENOFOVIR ALAFENAMIDE |
TABLET; ORAL |
10MG |
No
|
No
|
2024/01/02
(TA)
|
--
|
MYLAN LABS LTD |
None (Tentative Approval) |
| EMTRICITABINE AND TENOFOVIR ALAFENAMIDE |
211148 |
002 |
ANDA |
EMTRICITABINE, TENOFOVIR ALAFENAMIDE |
TABLET; ORAL |
15MG |
No
|
No
|
2024/01/02
(TA)
|
--
|
MYLAN LABS LTD |
None (Tentative Approval) |
| EMTRICITABINE AND TENOFOVIR ALAFENAMIDE |
211148 |
003 |
ANDA |
EMTRICITABINE, TENOFOVIR ALAFENAMIDE |
TABLET; ORAL |
25MG |
No
|
No
|
2024/01/02
(TA)
|
--
|
MYLAN LABS LTD |
None (Tentative Approval) |
| EMTRICITABINE AND TENOFOVIR ALAFENAMIDE |
211148 |
004 |
ANDA |
EMTRICITABINE, TENOFOVIR ALAFENAMIDE |
TABLET; ORAL |
120MG |
No
|
No
|
2024/01/02
(TA)
|
--
|
MYLAN LABS LTD |
None (Tentative Approval) |
| EMTRICITABINE AND TENOFOVIR ALAFENAMIDE |
211148 |
005 |
ANDA |
EMTRICITABINE, TENOFOVIR ALAFENAMIDE |
TABLET; ORAL |
200MG |
No
|
No
|
2024/01/02
(TA)
|
--
|
MYLAN LABS LTD |
None (Tentative Approval) |
| TENOFOVIR ALAFENAMIDE FUMARATE |
213867 |
001 |
ANDA |
TENOFOVIR ALAFENAMIDE FUMARATE |
TABLET;ORAL |
EQ 25MG BASE |
No
|
No
|
2024/03/21
|
2024/03/21
|
APOTEX |
Prescription |
| EFAVIRENZ, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE |
213509 |
001 |
NDA |
EFAVIRENZ, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE |
TABLET; ORAL |
400MG; 200MG; 25MG |
No
|
No
|
2024/03/22
(TA)
|
--
|
MYLAN |
Prescription |