EMTRICITABINE |
090488 |
001 |
ANDA |
EMTRICITABINE |
CAPSULE; ORAL |
200MG |
No
|
No
|
2008/12/23
(TA)
|
--
|
MATRIX LABS LTD |
None (Tentative Approval) |
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
090049 |
001 |
ANDA |
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET; ORAL |
200MG; 300MG |
No
|
No
|
2009/03/30
(TA)
|
--
|
MATRIX LABS LTD |
None (Tentative Approval) |
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
090437 |
001 |
ANDA |
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET; ORAL |
600MG; 200MG; 300MG |
No
|
No
|
2009/08/12
(TA)
|
--
|
MATRIX LABS LTD |
None (Tentative Approval) |
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
091593 |
001 |
ANDA |
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET; ORAL |
600MG |
No
|
No
|
2012/02/27
(TA)
|
--
|
CIPLA LIMITED |
None (Tentative Approval) |
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
091593 |
002 |
ANDA |
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET; ORAL |
200MG |
No
|
No
|
2012/02/27
(TA)
|
--
|
CIPLA LIMITED |
None (Tentative Approval) |
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
091593 |
003 |
ANDA |
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET; ORAL |
300MG |
No
|
No
|
2012/02/27
(TA)
|
--
|
CIPLA LIMITED |
None (Tentative Approval) |
EMTRICITABINE;TENOFOVIR DISOPROXIL FUMARATE;NEVIRAPINE |
206042 |
001 |
NDA |
EMTRICITABINE;TENOFOVIR DISOPROXIL FUMARATE;NEVIRAPINE |
TABLET;ORAL |
200MG;300MG;200MG |
No
|
No
|
2014/09/12
(TA)
|
--
|
MYLAN LABS LTD |
None (Tentative Approval) |
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE |
090894 |
001 |
ANDA |
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
200MG;300MG |
No
|
No
|
2017/06/08
|
2017/06/08
|
TEVA PHARMS USA |
Prescription |
EMTRICITABINE;RILPIVIRINE;TENOFOVIR DISOPROXIL FUMARATE |
208452 |
001 |
ANDA |
EMTRICITABINE;RILPIVIRINE;TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
200MG;25MG;300MG |
No
|
No
|
2017/11/20
(TA)
|
--
|
MYLAN PHARMS INC |
None (Tentative Approval) |
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE |
090513 |
001 |
ANDA |
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
200MG;300MG |
No
|
No
|
2018/01/26
|
2018/01/26
|
AUROBINDO PHARMA |
Prescription |
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE |
206436 |
001 |
ANDA |
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
200MG;300MG |
No
|
No
|
2018/04/09
|
2018/04/09
|
MYLAN |
Prescription |
EMTRICITABINE |
091168 |
001 |
ANDA |
EMTRICITABINE |
CAPSULE;ORAL |
200MG |
No
|
No
|
2018/07/02
|
2018/07/02
|
CIPLA |
Prescription |
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE |
209721 |
001 |
ANDA |
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
100MG;150MG |
No
|
No
|
2018/08/22
|
2018/08/22
|
AMNEAL PHARMS CO |
Prescription |
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE |
209721 |
002 |
ANDA |
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
133MG;200MG |
No
|
No
|
2018/08/22
|
2018/08/22
|
AMNEAL PHARMS CO |
Prescription |
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE |
209721 |
003 |
ANDA |
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
167MG;250MG |
No
|
No
|
2018/08/22
|
2018/08/22
|
AMNEAL PHARMS CO |
Prescription |
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE |
209721 |
004 |
ANDA |
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
200MG;300MG |
No
|
No
|
2018/08/22
|
2018/08/22
|
AMNEAL PHARMS CO |
Prescription |
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, 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, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE |
206894 |
001 |
ANDA |
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
600MG;200MG;300MG |
No
|
No
|
2019/06/03
|
2019/06/03
|
CIPLA |
Prescription |
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE |
212114 |
001 |
ANDA |
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
200MG;300MG |
No
|
No
|
2019/07/26
|
2019/07/26
|
LAURUS |
Prescription |