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) |
LAMIVUDINE/TENOFOVIR DISOPROXIL FUMARATE FDC TABS |
022459 |
001 |
NDA |
LAMIVUDINE; TENOFOVIR |
TABLET; ORAL |
300MG/300MG |
No
|
No
|
2009/11/05
(TA)
|
--
|
HETERO DRUGS LTD |
None (Tentative Approval) |
LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE |
200623 |
001 |
NDA |
LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET; ORAL |
300MG; 300MG |
No
|
No
|
2011/03/04
(TA)
|
--
|
CIPLA LIMITED |
None (Tentative Approval) |
LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE; NEVIRAPINE |
202171 |
001 |
NDA |
LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE; NEVIRAPINE |
TABLET; ORAL |
300MG; 300MG; 200MG |
No
|
No
|
2011/09/08
(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) |
LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE |
203283 |
001 |
NDA |
LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET; ORAL |
300MG; 300MG |
No
|
No
|
2012/11/08
(TA)
|
--
|
MACLEODS PHARMS LTD |
None (Tentative Approval) |
LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE |
202529 |
001 |
NDA |
LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE |
TABLET; ORAL |
300MG; 300MG |
No
|
No
|
2013/05/17
(TA)
|
--
|
RANBAXY LABS LTD |
None (Tentative Approval) |
LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE; NEVIRAPINE |
204505 |
001 |
NDA |
LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE; NEVIRAPINE |
TABLET; ORAL |
300MG; 300MG; 200MG |
No
|
No
|
2013/10/18
(TA)
|
--
|
AUROBINDO PHARMA LTD |
None (Tentative Approval) |
EFAVIRENZ, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATE |
204568 |
001 |
NDA |
EFAVIRENZ;LAMIVUDINE;TENOFOVIR DISOPROXIL FUMARATE |
TABLET; ORAL |
600MG |
No
|
No
|
2013/12/30
(TA)
|
--
|
CIPLA |
None (Tentative Approval) |
LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE; NEVIRAPINE |
205355 |
001 |
NDA |
LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE; NEVIRAPINE |
TABLET; ORAL |
300MG; 300MG; 200MG |
No
|
No
|
2014/03/14
(TA)
|
--
|
HETERO LABS LTD III |
None (Tentative Approval) |
EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE |
205861 |
001 |
NDA |
EFAVIRENZ;LAMIVUDINE;TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
600MG;300MG;300MG |
No
|
No
|
2014/08/14
(TA)
|
--
|
MACLEODS PHARMS LTD |
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) |
TENOFOVIR DISOPROXIL FUMARATE |
204402 |
001 |
ANDA |
TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
150MG |
No
|
No
|
2015/02/06
(TA)
|
--
|
LUPIN LTD |
None (Tentative Approval) |
TENOFOVIR DISOPROXIL FUMARATE |
204402 |
002 |
ANDA |
TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
200MG |
No
|
No
|
2015/02/06
(TA)
|
--
|
LUPIN LTD |
None (Tentative Approval) |
TENOFOVIR DISOPROXIL FUMARATE |
204402 |
003 |
ANDA |
TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
250MG |
No
|
No
|
2015/02/06
(TA)
|
--
|
LUPIN LTD |
None (Tentative Approval) |
TENOFOVIR DISOPROXIL FUMARATE |
204402 |
004 |
ANDA |
TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
300MG |
No
|
No
|
2015/02/06
(TA)
|
--
|
LUPIN LTD |
None (Tentative Approval) |
TENOFOVIR DISOPROXIL FUMARATE |
091612 |
001 |
ANDA |
TENOFOVIR DISOPROXIL FUMARATE |
TABLET;ORAL |
300MG |
No
|
No
|
2015/03/18
|
2015/03/18
|
TEVA PHARMS USA |
Prescription |