| ABACAVIR SULFATE |
078742 |
001 |
ANDA |
ABACAVIR SULFATE |
TABLET; ORAL |
300MG |
No
|
No
|
2007/04/05
(TA)
|
--
|
MATRIX LABS |
None (Tentative Approval) |
| ABACAVIR SULFATE |
022293 |
001 |
NDA |
ABACAVIR SULFATE |
TABLET; ORAL |
60MG |
No
|
No
|
2008/09/12
(TA)
|
--
|
AUROBINDO PHARMA |
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) |
| 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) |
| 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) |
| ABACAVIR SULFATE |
200733 |
001 |
NDA |
ABACAVIR SULFATE |
TABLET; ORAL |
60 MG |
TBD
|
No
|
2010/11/29
(TA)
|
--
|
MATRIX LABS LTD |
None (Tentative Approval) |
| ABACAVIR SULFATE |
078348 |
001 |
ANDA |
ABACAVIR SULFATE |
SOLUTION; ORAL |
20MG |
No
|
No
|
2011/02/16
(TA)
|
--
|
CIPLA LIMITED |
None (Tentative Approval) |
| ABACAVIR SULFATE |
022547 |
001 |
NDA |
ABACAVIR SULFATE |
TABLET; ORAL |
60MG |
No
|
No
|
2011/03/04
(TA)
|
--
|
CIPLA LIMITED |
None (Tentative Approval) |
| ABACAVIR SULFATE; LAMIVUDINE |
202007 |
001 |
NDA |
ABACAVIR SULFATE; LAMIVUDINE |
TABLET, FOR SUSPENSION; ORAL |
60MG; 30MG |
No
|
No
|
2011/05/12
(TA)
|
--
|
CIPLA LIMITED |
None (Tentative Approval) |
| ABACAVIR SULFATE; LAMIVUDINE |
202381 |
001 |
NDA |
ABACAVIR SULFATE; LAMIVUDINE |
TABLET; ORAL |
60MG; 30MG |
No
|
No
|
2012/01/31
(TA)
|
--
|
MYLAN LABS |
None (Tentative Approval) |
| ABACAVIR SULFATE |
091294 |
001 |
ANDA |
ABACAVIR SULFATE |
TABLET;ORAL |
EQ 300MG BASE |
No
|
No
|
2012/06/18
|
2012/06/18
|
MYLAN PHARMS INC |
Prescription |
| ABACAVIR SULFATE |
077844 |
001 |
ANDA |
ABACAVIR SULFATE |
TABLET;ORAL |
EQ 300MG BASE |
No
|
No
|
2012/12/17
|
2012/12/17
|
AUROBINDO PHARMA LTD |
Prescription |
| ABACAVIR SULFATE |
201570 |
001 |
ANDA |
ABACAVIR SULFATE |
TABLET;ORAL |
EQ 300MG BASE |
No
|
No
|
2012/12/17
|
2012/12/17
|
APOTEX INC |
Discontinued |
| ABACAVIR SULFATE |
091560 |
001 |
ANDA |
ABACAVIR SULFATE |
TABLET;ORAL |
EQ 300MG BASE |
No
|
Yes
|
2013/09/13
|
2013/09/13
|
HETERO LABS LTD III |
Prescription |
| 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 |
| ABACAVIR SULFATE; LAMIVUDINE |
205412 |
001 |
ANDA |
ABACAVIR SULFATE;LAMIVUDINE |
TABLET;ORAL |
600;300MG |
No
|
No
|
2014/09/25
(TA)
|
--
|
HETERO LABS LTD V |
None (Tentative Approval) |
| ABACAVIR SULFATE |
201107 |
001 |
ANDA |
ABACAVIR SULFATE |
SOLUTION;ORAL |
EQ 20MG BASE/ML |
No
|
No
|
2016/09/26
|
2016/09/26
|
HETERO LABS LTD III |
Prescription |
| ABACAVIR SULFATE AND LAMIVUDINE |
079246 |
001 |
ANDA |
ABACAVIR SULFATE; LAMIVUDINE |
TABLET;ORAL |
EQ 600MG BASE;300MG |
No
|
No
|
2016/09/29
|
2016/09/29
|
TEVA PHARMS USA |
Discontinued |
| ABACAVIR SULFATE |
091050 |
001 |
ANDA |
ABACAVIR SULFATE |
TABLET;ORAL |
EQ 300MG BASE |
No
|
No
|
2016/10/28
|
2016/10/28
|
CHARTWELL RX |
Prescription |
| ABACAVIR SULFATE AND LAMIVUDINE |
091144 |
001 |
ANDA |
ABACAVIR SULFATE; LAMIVUDINE |
TABLET;ORAL |
EQ 600MG BASE;300MG |
No
|
Yes
|
2017/03/28
|
2017/03/28
|
CIPLA |
Prescription |