EFAVIRENZ |
077916 |
001 |
ANDA |
EFAVIRENZ |
TABLET; ORAL |
600MG |
No
|
No
|
2006/05/24
(TA)
|
--
|
CIPLA LIMITED |
None (Tentative Approval) |
LAMIVUDINE; ZIDOVUDINE; EFAVIRENZ |
022096 |
001 |
NDA |
LAMIVUDINE; ZIDOVUDINE; EFAVIRENZ |
TABLET; ORAL |
150MG; 300MG; 600MG |
No
|
No
|
2007/06/01
(TA)
|
--
|
STRIDES ACROLAB |
None (Tentative Approval) |
STAVUDINE; LAMIVUDINE; EFAVIRENZ |
022097 |
001 |
NDA |
STAVUDINE; LAMIVUDINE; EFAVIRENZ |
TABLET; ORAL |
40MG; 150MG; 600MG |
No
|
No
|
2007/06/01
(TA)
|
--
|
STRIDES ACROLAB |
None (Tentative Approval) |
EFAVIRENZ |
078958 |
001 |
ANDA |
EFAVIRENZ |
TABLET; ORAL |
600MG |
No
|
No
|
2007/12/20
(TA)
|
--
|
EMCURE PHARMA |
None (Tentative Approval) |
EFAVIRENZ |
078883 |
001 |
ANDA |
EFAVIRENZ |
TABLET; ORAL |
600MG |
No
|
No
|
2008/04/25
(TA)
|
--
|
MATRIX LABS |
None (Tentative Approval) |
EFAVIRENZ |
090155 |
001 |
ANDA |
EFAVIRENZ |
CAPSULE; ORAL |
200MG |
No
|
No
|
2009/08/03
(TA)
|
--
|
CIPLA LIMITED |
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 |
022461 |
001 |
NDA |
EFAVIRENZ |
TABLET; ORAL |
50MG |
No
|
No
|
2009/11/24
(TA)
|
--
|
MATRIX LABS LTD |
None (Tentative Approval) |
EFAVIRENZ |
022461 |
002 |
NDA |
EFAVIRENZ |
TABLET; ORAL |
100MG |
No
|
No
|
2009/11/24
(TA)
|
--
|
MATRIX LABS LTD |
None (Tentative Approval) |
EFAVIRENZ |
022461 |
003 |
NDA |
EFAVIRENZ |
TABLET; ORAL |
200MG |
No
|
No
|
2009/11/24
(TA)
|
--
|
MATRIX LABS LTD |
None (Tentative Approval) |
EFAVIRENZ 200MG SCORED TABLETS |
022420 |
001 |
NDA |
EFAVIRENZ |
TABLET; ORAL |
200MG |
No
|
No
|
2010/02/12
(TA)
|
--
|
STRIDES ARCOLAB LTD |
None (Tentative Approval) |
EFAVIRENZ |
202042 |
001 |
ANDA |
EFAVIRENZ |
CAPSULE; ORAL |
50MG |
No
|
No
|
2012/01/19
(TA)
|
--
|
MICRO LABS LTD |
None (Tentative Approval) |
EFAVIRENZ |
202042 |
002 |
ANDA |
EFAVIRENZ |
CAPSULE; ORAL |
200MG |
No
|
No
|
2012/01/19
(TA)
|
--
|
MICRO 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) |
EFAVIRENZ |
202301 |
001 |
ANDA |
EFAVIRENZ |
TABLET; ORAL |
600MG |
No
|
No
|
2012/06/20
(TA)
|
--
|
MICRO LABS LTD |
None (Tentative Approval) |
EFAVIRENZ |
202990 |
001 |
ANDA |
EFAVIRENZ |
TABLET; ORAL |
600MG |
No
|
No
|
2012/06/25
(TA)
|
--
|
PAR FORMULATIONS PRIVATE 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) |
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) |