| DOLUTEGRAVIR |
215319 |
002 |
NDA |
DOLUTEGRAVIR |
FILM;ORAL |
10MG |
No
|
No
|
2023/04/28
(TA)
|
--
|
LAURUS GENERICS INC |
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 DISOPROXIL FUMARATE |
211868 |
001 |
NDA |
DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
50MG/300MG/300MG |
No
|
No
|
2023/07/12
(TA)
|
--
|
EMCURE PHARMS LTD |
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) |
| ABACAVIR; DOLUTEGRAVIR; LAMIVUDINE |
217070 |
001 |
NDA |
ABACAVIR; DOLUTEGRAVIR; LAMIVUDINE |
TABLET; ORAL |
60MG;5MG;30MG |
No
|
No
|
2023/08/14
(TA)
|
--
|
AUROBINDO PHARMA USA |
None (Tentative Approval) |
| DOLUTEGRAVIR; TENOFOVIR DISOPROXIL FUMARATE; LAMIVUDINE |
217016 |
001 |
NDA |
DOLUTEGRAVIR; TENOFOVIR DISOPROXIL FUMARATE; LAMIVUDINE |
TABLET; ORAL |
50MG/300MG/300MG |
No
|
No
|
2023/09/14
(TA)
|
--
|
STRIDES PHARMA |
None (Tentative Approval) |
| ABACAVIR; DOLUTEGRAVIR; LAMIVUDINE |
218383 |
001 |
ANDA |
ABACAVIR;DOLUTEGRAVIR;LAMIVUDINE |
TABLET;ORAL |
5MG |
No
|
No
|
2024/12/03
(TA)
|
--
|
LUPIN LTD |
None (Tentative Approval) |
| ABACAVIR; DOLUTEGRAVIR; LAMIVUDINE |
218383 |
002 |
ANDA |
ABACAVIR;DOLUTEGRAVIR;LAMIVUDINE |
TABLET;ORAL |
30MG |
No
|
No
|
2024/12/03
(TA)
|
--
|
LUPIN LTD |
None (Tentative Approval) |
| ABACAVIR; DOLUTEGRAVIR; LAMIVUDINE |
218383 |
003 |
ANDA |
ABACAVIR;DOLUTEGRAVIR;LAMIVUDINE |
TABLET;ORAL |
60MG |
No
|
No
|
2024/12/03
(TA)
|
--
|
LUPIN LTD |
None (Tentative Approval) |
| ABACAVIR || DOLUTEGRAVIR || LAMIVUDINE |
212181 |
001 |
ANDA |
ABACAVIR || DOLUTEGRAVIR || LAMIVUDINE |
TABLET |
50MG |
No
|
No
|
2024/12/05
(TA)
|
--
|
EMCURE PHARMS LTD |
None (Tentative Approval) |
| ABACAVIR || DOLUTEGRAVIR || LAMIVUDINE |
212181 |
002 |
ANDA |
ABACAVIR || DOLUTEGRAVIR || LAMIVUDINE |
TABLET |
300MG |
No
|
No
|
2024/12/05
(TA)
|
--
|
EMCURE PHARMS LTD |
None (Tentative Approval) |
| ABACAVIR || DOLUTEGRAVIR || LAMIVUDINE |
212181 |
003 |
ANDA |
ABACAVIR || DOLUTEGRAVIR || LAMIVUDINE |
TABLET |
600MG |
No
|
No
|
2024/12/05
(TA)
|
--
|
EMCURE PHARMS LTD |
None (Tentative Approval) |