LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE |
207315 |
001 |
NDA |
LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
75MG;75MG |
No
|
No
|
2017/05/05
(TA)
|
--
|
HETERO LABS LTD III |
None (Tentative Approval) |
LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE |
022344 |
001 |
NDA |
LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
300MG;300MG |
Yes
|
No
|
2018/05/15
|
2018/05/15
|
AUROBINDO PHARMA LTD |
Discontinued |
EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE |
022343 |
001 |
NDA |
EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
600MG;300MG;300MG |
Yes
|
No
|
2018/08/15
|
2018/08/15
|
AUROBINDO PHARMA 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 |
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) |