| LOPINAVIR; RITONAVIR |
090471 |
001 |
ANDA |
LOPINAVIR; RITONAVIR |
TABLET; ORAL |
100MG; 25MG |
No
|
No
|
2009/03/10
(TA)
|
--
|
AUROBINDO PHARMA LTD |
None (Tentative Approval) |
| LOPINAVIR; RITONAVIR |
090471 |
002 |
ANDA |
LOPINAVIR; RITONAVIR |
TABLET; ORAL |
200MG; 50MG |
No
|
No
|
2009/03/10
(TA)
|
--
|
AUROBINDO PHARMA LTD |
None (Tentative Approval) |
| LOPINAVIR; RITONAVIR |
090371 |
001 |
ANDA |
LOPINAVIR; RITONAVIR |
TABLET; ORAL |
200MG; 50MG |
No
|
No
|
2009/11/20
(TA)
|
--
|
CIPLA LIMITED |
None (Tentative Approval) |
| LOPINAVIR; RITONAVIR |
091202 |
001 |
ANDA |
LOPINAVIR; RITONAVIR |
TABLET; ORAL |
100MG; 25MG |
No
|
No
|
2011/06/08
(TA)
|
--
|
MYLAN PHARMA |
None (Tentative Approval) |
| LOPINAVIR; RITONAVIR |
091202 |
002 |
ANDA |
LOPINAVIR; RITONAVIR |
TABLET; ORAL |
200MG; 50MG |
No
|
No
|
2011/06/08
(TA)
|
--
|
MYLAN PHARMA |
None (Tentative Approval) |
| ATAZANAVIR SULFATE AND RITONAVIR |
022282 |
001 |
NDA |
ATAZANAVIR SULFATE; RITONAVIR |
TABLET; ORAL |
300MG/100MG |
No
|
No
|
2011/11/18
(TA)
|
--
|
MATRIX LABS LTD |
None (Tentative Approval) |
| LOPINAVIR; RITONAVIR |
091203 |
001 |
ANDA |
LOPINAVIR; RITONAVIR |
SOLUTION; ORAL |
80MG; 20MG |
No
|
No
|
2012/06/29
(TA)
|
--
|
CIPLA LIMITED |
None (Tentative Approval) |
| ATAZANAVIR SULFATE; RITONAVIR |
205508 |
001 |
NDA |
ATAZANAVIR SULFATE; RITONAVIR |
TABLET; ORAL |
300MG; 100MG |
No
|
No
|
2014/03/17
(TA)
|
--
|
EMCURE PHARMS 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) |
| RITONAVIR |
202573 |
001 |
ANDA |
RITONAVIR |
TABLET;ORAL |
100MG |
No
|
No
|
2015/01/15
|
2015/01/15
|
CIPLA |
Prescription |
| RITONAVIR |
205040 |
001 |
NDA |
RITONAVIR |
TABLET; ORAL |
25MG |
TBD
|
No
|
2015/03/29
(TA)
|
--
|
CIPLA LIMITED |
None (Tentative Approval) |
| RITONAVIR |
205040 |
002 |
NDA |
RITONAVIR |
TABLET; ORAL |
50MG |
No
|
No
|
2015/03/29
(TA)
|
--
|
CIPLA LIMITED |
None (Tentative Approval) |
| LOPINAVIR AND RITONAVIR |
205425 |
001 |
NDA |
LOPINAVIR;RITONAVIR |
PELLETS;ORAL |
40MG;10MG |
No
|
No
|
2015/05/21
(TA)
|
--
|
CIPLA LTD |
None (Tentative Approval) |
| RITONAVIR |
202738 |
001 |
ANDA |
RITONAVIR |
TABLET;ORAL |
100MG |
No
|
No
|
2016/03/02
(TA)
|
--
|
MYLAN PHARMS INC |
None (Tentative Approval) |
| LOPINAVIR; RITONAVIR |
204739 |
001 |
ANDA |
LOPINAVIR;RITONAVIR |
TABLET;ORAL |
100MG;25MG |
No
|
No
|
2016/03/07
(TA)
|
--
|
MACLEODS PHARMS LTD |
None (Tentative Approval) |
| LOPINAVIR; RITONAVIR |
204739 |
002 |
ANDA |
LOPINAVIR;RITONAVIR |
TABLET;ORAL |
200MG;50MG |
No
|
No
|
2016/03/07
(TA)
|
--
|
MACLEODS PHARMS LTD |
None (Tentative Approval) |
| LOPINAVIR AND RITONAVIR |
207407 |
001 |
ANDA |
LOPINAVIR; RITONAVIR |
SOLUTION;ORAL |
80MG/ML;20MG/ML |
No
|
No
|
2016/12/27
|
2016/12/27
|
LANNETT CO INC |
Prescription |
| RITONAVIR |
204587 |
001 |
ANDA |
RITONAVIR |
TABLET;ORAL |
100MG |
No
|
No
|
2018/09/17
|
2018/09/17
|
HETERO LABS LTD III |
Prescription |
| RITONAVIR |
206614 |
001 |
ANDA |
RITONAVIR |
TABLET;ORAL |
100MG |
No
|
No
|
2018/09/17
|
2018/09/17
|
AUROBINDO PHARMA LTD |
Prescription |
| RITONAVIR |
208890 |
001 |
ANDA |
RITONAVIR |
TABLET;ORAL |
100MG |
No
|
No
|
2018/09/17
|
2018/09/17
|
AMNEAL |
Prescription |