| LAMIVUDINE; ZIDOVUDINE; EFAVIRENZ |
206040 |
001 |
NDA |
LAMIVUDINE;ZIDOVUDINE;EFAVIRENZ |
TABLET;ORAL |
150MG;300MG;600MG |
No
|
No
|
2014/09/04
(TA)
|
--
|
MYLAN LABS LTD |
None (Tentative Approval) |
| EFAVIRENZ |
091175 |
001 |
ANDA |
EFAVIRENZ |
TABLET;ORAL |
600MG |
No
|
No
|
2015/11/23
(TA)
|
--
|
TEVA PHARMS USA |
None (Tentative Approval) |
| EFAVIRENZ |
091471 |
001 |
ANDA |
EFAVIRENZ |
TABLET;ORAL |
600MG |
No
|
No
|
2016/02/17
|
2016/02/17
|
MYLAN |
Discontinued |
| EFAVIRENZ |
207895 |
001 |
ANDA |
EFAVIRENZ |
TABLET;ORAL |
600MG |
No
|
No
|
2017/05/19
(TA)
|
--
|
PHARMACARE LTD |
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) |
| EFAVIRENZ |
078064 |
001 |
ANDA |
EFAVIRENZ |
CAPSULE;ORAL |
50MG |
No
|
No
|
2017/12/15
|
2017/12/15
|
AUROBINDO PHARMA |
Prescription |
| EFAVIRENZ |
078064 |
002 |
ANDA |
EFAVIRENZ |
CAPSULE;ORAL |
100MG |
No
|
No
|
2017/12/15
|
2017/12/15
|
AUROBINDO PHARMA |
Prescription |
| EFAVIRENZ |
078064 |
003 |
ANDA |
EFAVIRENZ |
CAPSULE;ORAL |
200MG |
No
|
Yes
|
2017/12/15
|
2017/12/15
|
AUROBINDO PHARMA |
Prescription |
| EFAVIRENZ |
205389 |
001 |
NDA |
EFAVIRENZ |
TABLET;ORAL |
50MG |
No
|
No
|
2018/02/23
(TA)
|
--
|
MICRO LABS LTD INDIA |
None (Tentative Approval) |
| EFAVIRENZ |
205389 |
002 |
NDA |
EFAVIRENZ |
TABLET;ORAL |
100MG |
No
|
No
|
2018/02/23
(TA)
|
--
|
MICRO LABS LTD INDIA |
None (Tentative Approval) |
| EFAVIRENZ |
205389 |
003 |
NDA |
EFAVIRENZ |
TABLET;ORAL |
200MG |
No
|
No
|
2018/02/23
(TA)
|
--
|
MICRO LABS LTD INDIA |
None (Tentative Approval) |
| EFAVIRENZ |
204869 |
001 |
ANDA |
EFAVIRENZ |
TABLET;ORAL |
600MG |
No
|
No
|
2018/03/12
|
2018/03/12
|
STRIDES PHARMA |
Prescription |
| EFAVIRENZ |
078886 |
001 |
ANDA |
EFAVIRENZ |
TABLET;ORAL |
600MG |
No
|
Yes
|
2018/04/27
|
2018/04/27
|
HETERO LABS LTD III |
Prescription |
| EFAVIRENZ |
204766 |
001 |
ANDA |
EFAVIRENZ |
TABLET;ORAL |
600MG |
No
|
No
|
2018/06/15
|
2018/06/15
|
CIPLA |
Prescription |
| 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 |
205322 |
001 |
ANDA |
EFAVIRENZ |
TABLET;ORAL |
600MG |
No
|
No
|
2018/08/30
|
2018/08/30
|
AUROBINDO PHARMA |
Discontinued |
| EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE |
203041 |
001 |
ANDA |
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
600MG;200MG;300MG |
No
|
Yes
|
2018/09/04
|
2018/09/04
|
AUROBINDO PHARMA |
Prescription |
| EFAVIRENZ |
077673 |
001 |
ANDA |
EFAVIRENZ |
TABLET;ORAL |
600MG |
No
|
No
|
2018/09/21
|
2018/09/21
|
AUROBINDO PHARMA LTD |
Prescription |
| EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE |
091215 |
001 |
ANDA |
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
600MG;200MG;300MG |
No
|
No
|
2018/11/09
|
2018/11/09
|
TEVA PHARMS USA |
Prescription |
| 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 |