| ABACAVIR SULFATE AND LAMIVUDINE |
206151 |
001 |
ANDA |
ABACAVIR SULFATE; LAMIVUDINE |
TABLET;ORAL |
EQ 600MG BASE;300MG |
No
|
No
|
2017/03/28
|
2017/03/28
|
AUROBINDO PHARMA |
Discontinued |
| ABACAVIR AND LAMIVUDINE |
208775 |
001 |
NDA |
ABACAVIR; LAMIVUDINE |
TABLET, FOR SUSPENSION;ORAL |
120MG;60MG |
No
|
No
|
2017/04/06
(TA)
|
--
|
CIPLA LIMITED |
None (Tentative Approval) |
| LAMIVUDINE AND ZIDOVUDINE |
077558 |
001 |
ANDA |
LAMIVUDINE; ZIDOVUDINE |
TABLET;ORAL |
150MG;300MG |
No
|
No
|
2017/05/05
|
2017/05/05
|
AUROBINDO PHARMA |
Prescription |
| 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) |
| EFAVIRENZ, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATE |
204119 |
001 |
NDA |
EFAVIRENZ;LAMIVUDINE;TENOFOVIR DISOPROXIL FUMARATE |
TABLET; ORAL |
600MG;300MG;300MG |
No
|
No
|
2017/06/30
(TA)
|
--
|
HETERO DRUGS LTD |
None (Tentative Approval) |
| DOLUTEGRAVIR, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATE |
209670 |
001 |
NDA |
DOLUTEGRAVIR;LAMIVUDINE;TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
50MG;300MG;300MG |
No
|
No
|
2017/08/02
(TA)
|
--
|
MYLAN PHARMS INC |
None (Tentative Approval) |
| LAMIVUDINE AND ZIDOVUDINE |
206375 |
001 |
ANDA |
LAMIVUDINE; ZIDOVUDINE |
TABLET;ORAL |
150MG;300MG |
No
|
No
|
2018/04/10
|
2018/04/10
|
EPIC PHARMA LLC |
Prescription |
| LAMIVUDINE |
090457 |
001 |
ANDA |
LAMIVUDINE |
TABLET;ORAL |
150MG |
No
|
No
|
2018/04/19
|
2018/04/19
|
STRIDES PHARMA |
Prescription |
| LAMIVUDINE |
090457 |
002 |
ANDA |
LAMIVUDINE |
TABLET;ORAL |
300MG |
No
|
No
|
2018/04/19
|
2018/04/19
|
STRIDES PHARMA |
Prescription |
| 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 |
| LAMIVUDINE, NEVIRAPINE AND ZIDOVUDINE |
205626 |
001 |
NDA |
LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE |
TABLET;ORAL |
150MG;200MG;300MG |
Yes
|
No
|
2018/08/13
|
2018/08/13
|
MICRO LABS |
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 |
| LAMIVUDINE AND ZIDOVUDINE |
090679 |
001 |
ANDA |
LAMIVUDINE; ZIDOVUDINE |
TABLET;ORAL |
150MG;300MG |
No
|
No
|
2018/08/29
|
2018/08/29
|
MACLEODS PHARMS LTD |
Prescription |
| LAMIVUDINE AND ZIDOVUDINE |
077411 |
001 |
ANDA |
LAMIVUDINE; ZIDOVUDINE |
TABLET;ORAL |
150MG;300MG |
No
|
No
|
2018/09/07
|
2018/09/07
|
CIPLA |
Prescription |
| ABACAVIR SULFATE AND LAMIVUDINE |
090159 |
001 |
ANDA |
ABACAVIR SULFATE; LAMIVUDINE |
TABLET;ORAL |
EQ 600MG BASE;300MG |
No
|
No
|
2018/11/15
|
2018/11/15
|
AUROBINDO PHARMA LTD |
Prescription |
| ABACAVIR SULFATE AND LAMIVUDINE |
208990 |
001 |
ANDA |
ABACAVIR SULFATE; LAMIVUDINE |
TABLET;ORAL |
EQ 600MG BASE;300MG |
No
|
No
|
2018/11/15
|
2018/11/15
|
ZYDUS PHARMS |
Discontinued |
| DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE |
210787 |
001 |
NDA |
DOLUTEGRAVIR;LAMIVUDINE;TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
50MG; 300MG;300MG |
No
|
No
|
2019/02/01
(TA)
|
--
|
LAURUS LABS LTD |
None (Tentative Approval) |
| LAMIVUDINE |
078545 |
001 |
ANDA |
LAMIVUDINE |
TABLET;ORAL |
150MG |
No
|
No
|
2019/03/05
|
2019/03/05
|
PHARMOBEDIENT |
Discontinued |
| LAMIVUDINE |
078545 |
002 |
ANDA |
LAMIVUDINE |
TABLET;ORAL |
300MG |
No
|
No
|
2019/03/05
|
2019/03/05
|
PHARMOBEDIENT |
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 |