LAMIVUDINE |
078545 |
001 |
ANDA |
LAMIVUDINE |
TABLET;ORAL |
150MG |
No
|
No
|
2019/03/05
|
2019/03/05
|
MYLAN LABS LTD |
Discontinued |
LAMIVUDINE |
078545 |
002 |
ANDA |
LAMIVUDINE |
TABLET;ORAL |
300MG |
No
|
No
|
2019/03/05
|
2019/03/05
|
MYLAN LABS LTD |
Discontinued |
EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE |
210649 |
001 |
NDA |
EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
400MG;300MG;300MG |
No
|
No
|
2019/03/15
|
2019/03/15
|
MACLEODS PHARMS LTD |
Discontinued |
LAMIVUDINE |
211306 |
001 |
ANDA |
LAMIVUDINE |
TABLET;ORAL |
100MG |
No
|
No
|
2019/03/21
|
2019/03/21
|
ANNORA |
Prescription |
DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE |
210796 |
001 |
NDA |
DOLUTEGRAVIR;LAMIVUDINE;TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
50MG/300MG/300MG |
No
|
No
|
2019/03/25
(TA)
|
--
|
MACLEODS PHARMS LTD |
None (Tentative Approval) |
LAMIVUDINE |
090198 |
001 |
ANDA |
LAMIVUDINE |
TABLET;ORAL |
150MG |
No
|
No
|
2019/05/01
|
2019/05/01
|
MACLEODS PHARMS LTD |
Prescription |
LAMIVUDINE |
090198 |
002 |
ANDA |
LAMIVUDINE |
TABLET;ORAL |
300MG |
No
|
No
|
2019/05/01
|
2019/05/01
|
MACLEODS PHARMS LTD |
Prescription |
LAMIVUDINE AND ZIDOVUDINE |
079079 |
001 |
ANDA |
LAMIVUDINE; ZIDOVUDINE |
TABLET;ORAL |
150MG;300MG |
No
|
No
|
2019/08/12
|
2019/08/12
|
MYLAN LABS LTD |
Discontinued |
EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE |
212786 |
001 |
ANDA |
EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
600MG;300MG;300MG |
No
|
No
|
2020/05/14
|
2020/05/14
|
LAURUS |
Prescription |
EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE |
213038 |
001 |
ANDA |
EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
400MG;300MG;300MG |
No
|
No
|
2020/05/14
|
2020/05/14
|
LAURUS |
Prescription |
DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE |
213556 |
001 |
NDA |
DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
50MG; 300MG; 300MG |
No
|
No
|
2020/10/06
(TA)
|
--
|
SHANGHAI DESANA BIO-PHARMACEUTICALS CO LTD |
None (Tentative Approval) |
DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE |
212303 |
001 |
NDA |
DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET; ORAL |
50MG/300MG/300MG |
No
|
No
|
2021/06/25
(TA)
|
--
|
LUPIN PHARMS |
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) |
ABACAVIR SULFATE AND LAMIVUDINE |
216332 |
001 |
ANDA |
ABACAVIR SULFATE; LAMIVUDINE |
TABLET;ORAL |
EQ 600MG BASE;300MG |
No
|
No
|
2022/07/25
|
2022/07/25
|
LAURUS |
Prescription |
ABACAVIR; DOLUTEGRAVIR; LAMIVUDINE |
216223 |
001 |
ANDA |
ABACAVIR;DOLUTEGRAVIR;LAMIVUDINE |
TABLET;ORAL |
600MG;50MG;300MG |
No
|
No
|
2022/08/11
(TA)
|
--
|
LAURUS LABS LTD |
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) |
LAMIVUDINE |
091475 |
001 |
ANDA |
LAMIVUDINE |
SOLUTION;ORAL |
10MG/ML |
No
|
No
|
2023/10/06
|
2023/10/06
|
HETERO LABS LTD III |
Prescription |