LAMIVUDINE |
200406 |
002 |
ANDA |
LAMIVUDINE |
TABLET; ORAL |
300MG |
No
|
No
|
2012/05/30
(TA)
|
--
|
MICRO LABS LTD |
None (Tentative Approval) |
LAMIVUDINE; ZIDOVUDINE |
202814 |
001 |
NDA |
LAMIVUDINE; ZIDOVUDINE |
TABLET, FOR SUSPENSION; ORAL |
30MG; 60MG |
No
|
No
|
2012/06/15
(TA)
|
--
|
CIPLA LIMITED |
None (Tentative Approval) |
LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE |
202685 |
001 |
NDA |
LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE |
TABLET, FOR SUSPENSION; ORAL |
30MG; 50MG; 60MG |
No
|
No
|
2012/09/21
(TA)
|
--
|
STRIDES ARCOLAB LTD |
None (Tentative Approval) |
LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE |
203076 |
001 |
NDA |
LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE |
TABLET; ORAL SUSPENSION |
30MG; 50MG; 60MG |
No
|
No
|
2012/10/16
(TA)
|
--
|
CIPLA LTD |
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) |
ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE |
202912 |
001 |
ANDA |
ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE |
TABLET;ORAL |
EQ 300MG BASE;150MG;300MG |
No
|
Yes
|
2013/12/05
|
2013/12/05
|
LUPIN LTD |
Prescription |
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 |
202941 |
001 |
ANDA |
LAMIVUDINE |
TABLET;ORAL |
100MG |
No
|
Yes
|
2014/01/02
|
2014/01/02
|
APOTEX |
Prescription |
LAMIVUDINE |
203260 |
001 |
ANDA |
LAMIVUDINE |
TABLET;ORAL |
100MG |
No
|
No
|
2014/01/02
|
2014/01/02
|
HETERO LABS LTD V |
Prescription |
LAMIVUDINE |
203277 |
001 |
ANDA |
LAMIVUDINE |
TABLET;ORAL |
150MG |
No
|
No
|
2014/01/06
|
2014/01/06
|
HETERO LABS LTD V |
Prescription |
LAMIVUDINE |
203277 |
002 |
ANDA |
LAMIVUDINE |
TABLET;ORAL |
300MG |
No
|
No
|
2014/01/06
|
2014/01/06
|
HETERO LABS LTD V |
Prescription |
LAMIVUDINE AND ZIDOVUDINE |
203259 |
001 |
ANDA |
LAMIVUDINE; ZIDOVUDINE |
TABLET;ORAL |
150MG;300MG |
No
|
No
|
2014/02/03
|
2014/02/03
|
HETERO LABS LTD V |
Prescription |
LAMIVUDINE; ZIDOVUDINE |
204914 |
001 |
NDA |
LAMIVUDINE; ZIDOVUDINE |
TABLET; ORAL SUSPENSION |
30MG; 60MG |
No
|
No
|
2014/02/04
(TA)
|
--
|
MYLAN LABS |
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) |
LAMIVUDINE AND ZIDOVUDINE |
204005 |
001 |
ANDA |
LAMIVUDINE; ZIDOVUDINE |
TABLET;ORAL |
150MG;300MG |
No
|
No
|
2014/08/28
|
2014/08/28
|
NATCO |
Discontinued |
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) |
ATAZANAVIR SULFATE;RITONAVIR;LAMIVUDINE;ZIDOVUDINE |
206041 |
001 |
NDA |
ATAZANAVIR SULFATE;RITONAVIR;LAMIVUDINE;ZIDOVUDINE |
TABLET;ORAL |
300MG;100MG;150MG;300MG |
No
|
No
|
2014/09/04
(TA)
|
--
|
MYLAN LABS LTD |
None (Tentative Approval) |