LAMIVUDINE, NEVIRAPINE, AND STAVUDINE |
200244 |
001 |
NDA |
LAMIVUDINE; NEVIRAPINE; STAVUDINE |
TABLET; ORAL |
150MG; 200MG; 30MG |
No
|
No
|
2010/09/10
(TA)
|
--
|
HETERO DRUGS LTD |
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) |
LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE |
202157 |
001 |
NDA |
LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE |
TABLET; ORAL |
150MG; 200MG; 300MG |
No
|
No
|
2011/11/18
(TA)
|
--
|
HETERO LABS UNIT III |
None (Tentative Approval) |
LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE |
202589 |
001 |
NDA |
LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE |
TABLET; ORAL |
150MG; 200MG; 300MG |
No
|
No
|
2012/02/08
(TA)
|
--
|
MACLEODS PHARMS LTD |
None (Tentative Approval) |
NEVIRAPINE |
202212 |
001 |
NDA |
NEVIRAPINE |
TABLET, FOR SUSPENSION; ORAL |
50MG |
No
|
No
|
2012/04/30
(TA)
|
--
|
CIPLA LIMITED |
None (Tentative Approval) |
NEVIRAPINE |
202212 |
002 |
NDA |
NEVIRAPINE |
TABLET, FOR SUSPENSION; ORAL |
100MG |
No
|
No
|
2012/04/30
(TA)
|
--
|
CIPLA LIMITED |
None (Tentative Approval) |
NEVIRAPINE |
077521 |
001 |
ANDA |
NEVIRAPINE |
TABLET;ORAL |
200MG |
No
|
No
|
2012/05/22
|
2012/05/22
|
AUROBINDO |
Prescription |
NEVIRAPINE |
077702 |
001 |
ANDA |
NEVIRAPINE |
SUSPENSION;ORAL |
50MG/5ML |
No
|
Yes
|
2012/05/22
|
2012/05/22
|
AUROBINDO |
Prescription |
NEVIRAPINE |
077956 |
001 |
ANDA |
NEVIRAPINE |
TABLET;ORAL |
200MG |
No
|
No
|
2012/05/22
|
2012/05/22
|
CIPLA |
Prescription |
NEVIRAPINE |
078195 |
001 |
ANDA |
NEVIRAPINE |
TABLET;ORAL |
200MG |
No
|
No
|
2012/05/22
|
2012/05/22
|
STRIDES PHARMA |
Prescription |
NEVIRAPINE |
078584 |
001 |
ANDA |
NEVIRAPINE |
TABLET;ORAL |
200MG |
No
|
No
|
2012/05/22
|
2012/05/22
|
HETERO LABS LTD III |
Prescription |
NEVIRAPINE |
078644 |
001 |
ANDA |
NEVIRAPINE |
TABLET;ORAL |
200MG |
No
|
No
|
2012/05/22
|
2012/05/22
|
PRINSTON INC |
Discontinued |
NEVIRAPINE |
078864 |
001 |
ANDA |
NEVIRAPINE |
TABLET;ORAL |
200MG |
No
|
No
|
2012/05/22
|
2012/05/22
|
NORVIUM BIOSCIENCE |
Discontinued |
NEVIRAPINE |
202523 |
001 |
ANDA |
NEVIRAPINE |
TABLET;ORAL |
200MG |
No
|
No
|
2012/05/22
|
2012/05/22
|
MYLAN PHARMS INC |
Prescription |
NEVIRAPINE |
203021 |
001 |
ANDA |
NEVIRAPINE |
TABLET;ORAL |
200MG |
No
|
No
|
2012/05/22
|
2012/05/22
|
APOTEX INC |
Discontinued |
NEVIRAPINE |
203080 |
001 |
ANDA |
NEVIRAPINE |
TABLET;ORAL |
200MG |
No
|
No
|
2012/05/22
|
2012/05/22
|
MICRO LABS LTD |
Prescription |
NEVIRAPINE |
203176 |
001 |
ANDA |
NEVIRAPINE |
TABLET;ORAL |
200MG |
No
|
No
|
2012/05/22
|
2012/05/22
|
TECH ORGANIZED |
Discontinued |
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; 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) |