STAVUDINE; LAMIVUDINE; NEVIRAPINE |
021837 |
001 |
NDA |
STAVUDINE; LAMIVUDINE; NEVIRAPINE |
TABLET; ORAL |
40MG; 150MG; 200MG |
No
|
No
|
2008/03/20
(TA)
|
--
|
STRIDES ARCOLAB |
None (Tentative Approval) |
STAVUDINE; LAMIVUDINE; NEVIRAPINE |
022177 |
001 |
NDA |
STAVUDINE; LAMIVUDINE; NEVIRAPINE |
TABLET; ORAL |
30MG; 150MG; 200MG |
No
|
No
|
2008/03/20
(TA)
|
--
|
STRIDES ACROLAB |
None (Tentative Approval) |
LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE |
022061 |
001 |
NDA |
LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE |
TABLET; ORAL |
150MG; 200MG; 300MG |
No
|
No
|
2008/10/21
(TA)
|
--
|
MATRIX LABS |
None (Tentative Approval) |
ABACAVIR SULFATE; LAMIVUDINE |
022295 |
001 |
NDA |
ABACAVIR SULFATE; LAMIVUDINE |
TABLET; ORAL |
60MG; 30MG |
No
|
No
|
2008/12/19
(TA)
|
--
|
AUROBINDO PHARMA LTD |
None (Tentative Approval) |
STAVUDINE; LAMIVUDINE; NEVIRAPINE |
022346 |
001 |
NDA |
STAVUDINE; LAMIVUDINE; NEVIRAPINE |
TABLET; ORAL |
30MG; 150MG; 200MG |
No
|
No
|
2009/02/27
(TA)
|
--
|
PHARMACARE LTD |
None (Tentative Approval) |
STAVUDINE; LAMIVUDINE; NEVIRAPINE |
022346 |
002 |
NDA |
STAVUDINE; LAMIVUDINE; NEVIRAPINE |
TABLET; ORAL |
40MG; 150MG; 200MG |
No
|
No
|
2009/02/27
(TA)
|
--
|
PHARMACARE LTD |
None (Tentative Approval) |
LAMIVUDINE |
090433 |
001 |
ANDA |
LAMIVUDINE |
TABLET; ORAL |
150MG |
No
|
No
|
2009/03/16
(TA)
|
--
|
ALKEM LABS LTD |
None (Tentative Approval) |
STAVUDINE; LAMIVUDINE |
022347 |
001 |
NDA |
STAVUDINE; LAMIVUDINE |
TABLET; ORAL |
30MG; 150MG |
No
|
No
|
2009/03/18
(TA)
|
--
|
PHARMACARE LTD |
None (Tentative Approval) |
STAVUDINE; LAMIVUDINE |
022347 |
002 |
NDA |
STAVUDINE; LAMIVUDINE |
TABLET; ORAL |
40MG; 150MG |
No
|
No
|
2009/03/18
(TA)
|
--
|
PHARMACARE LTD |
None (Tentative Approval) |
ABACAVIR SULFATE; LAMIVUDINE |
090519 |
001 |
ANDA |
ABACAVIR SULFATE; LAMIVUDINE |
TABLET; ORAL |
600MG; 300MG |
No
|
No
|
2009/03/30
(TA)
|
--
|
MATRIX LABS LTD |
None (Tentative Approval) |
LAMIVUDINE, ZIDOVUDINE TABS 150MG/300MG CO-PACKAGED WITH NEVIRAPINE TABS 200MG |
022356 |
001 |
NDA |
LAMIVUDINE; ZIDOVUDINE; NEVIRAPINE |
TABLET; ORAL |
150MG; 300MG; 200MG |
No
|
No
|
2009/05/07
(TA)
|
--
|
HETERO DRUGS LTD |
None (Tentative Approval) |
ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE |
090309 |
001 |
ANDA |
ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE |
TABLET; ORAL |
EQ 300MG BASE; 150MG; 300MG |
No
|
No
|
2009/07/15
(TA)
|
--
|
MYLAN PHARMA |
None (Tentative Approval) |
STAVUDINE; LAMIVUDINE; NEVIRAPINE |
022342 |
001 |
NDA |
STAVUDINE; LAMIVUDINE; NEVIRAPINE |
TABLET; ORAL |
30MG; 150MG; 200MG |
No
|
No
|
2009/07/16
(TA)
|
--
|
EMCURE PHARMA |
None (Tentative Approval) |
STAVUDINE; LAMIVUDINE; NEVIRAPINE |
022342 |
002 |
NDA |
STAVUDINE; LAMIVUDINE; NEVIRAPINE |
TABLET; ORAL |
40MG; 150MG; 200MG |
No
|
No
|
2009/07/16
(TA)
|
--
|
EMCURE PHARMA |
None (Tentative Approval) |
LAMIVUDINE; ZIDOVUDINE |
022296 |
001 |
NDA |
LAMIVUDINE; ZIDOVUDINE |
TABLET; ORAL |
30MG; 60MG |
No
|
No
|
2009/07/23
(TA)
|
--
|
AUROBINDO PHARMA 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; NEVIRAPINE; ZIDOVUDINE |
022464 |
001 |
NDA |
LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE |
TABLET; ORAL |
150MG; 200MG; 300MG |
No
|
No
|
2009/12/22
(TA)
|
--
|
STRIDES ARCOLAB LTD |
None (Tentative Approval) |
LAMIVUDINE AND STAVUDINE |
022479 |
001 |
NDA |
LAMIVUDINE; STAVUDINE |
TABLET; ORAL |
150MG/30MG |
No
|
No
|
2010/05/17
(TA)
|
--
|
HETERO DRUGS LTD |
None (Tentative Approval) |
LAMIVUDINE/NEVIRAPINE/ZIDOVUDINE TABLETS |
200793 |
001 |
NDA |
Lamivudine; Nevirapine; Zidovudine |
TABLET, FOR SUSPENSION; ORAL |
30MG; 50MG; 60MG |
No
|
No
|
2010/07/08
(TA)
|
--
|
MATRIX LABS |
None (Tentative Approval) |
LAMIVUDINE AND STAVUDINE |
022541 |
001 |
NDA |
LAMIVUDINE; STAVUDINE |
TABLET; ORAL |
150MG; 30MG |
No
|
No
|
2010/08/05
(TA)
|
--
|
MACLEODS PHARMA |
None (Tentative Approval) |