IRBESARTAN AND HYDROCHLOROTHIAZIDE |
201505 |
001 |
ANDA |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
TABLET;ORAL |
12.5MG;150MG |
No
|
No
|
2012/10/15
|
2012/10/15
|
APOTEX INC |
Discontinued |
IRBESARTAN AND HYDROCHLOROTHIAZIDE |
201505 |
001 |
ANDA |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
TABLET;ORAL |
12.5MG;150MG |
No
|
No
|
2012/10/15
(TA)
|
2012/10/15
|
APOTEX INC |
Discontinued |
IRBESARTAN AND HYDROCHLOROTHIAZIDE |
201505 |
002 |
ANDA |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
TABLET;ORAL |
12.5MG;300MG |
No
|
No
|
2012/10/15
|
2012/10/15
|
APOTEX INC |
Discontinued |
IRBESARTAN AND HYDROCHLOROTHIAZIDE |
201505 |
002 |
ANDA |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
TABLET;ORAL |
12.5MG;300MG |
No
|
No
|
2012/10/15
(TA)
|
2012/10/15
|
APOTEX INC |
Discontinued |
IRBESARTAN AND HYDROCHLOROTHIAZIDE |
091539 |
001 |
ANDA |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
TABLET;ORAL |
12.5MG;150MG |
No
|
No
|
2012/10/22
|
2012/10/22
|
WATSON LABS INC |
Discontinued |
IRBESARTAN AND HYDROCHLOROTHIAZIDE |
091539 |
001 |
ANDA |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
TABLET;ORAL |
12.5MG;150MG |
No
|
No
|
2012/10/22
(TA)
|
2012/10/22
|
WATSON LABS INC |
Discontinued |
IRBESARTAN AND HYDROCHLOROTHIAZIDE |
091539 |
002 |
ANDA |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
TABLET;ORAL |
12.5MG;300MG |
No
|
No
|
2012/10/22
|
2012/10/22
|
WATSON LABS INC |
Discontinued |
IRBESARTAN AND HYDROCHLOROTHIAZIDE |
091539 |
002 |
ANDA |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
TABLET;ORAL |
12.5MG;300MG |
No
|
No
|
2012/10/22
(TA)
|
2012/10/22
|
WATSON LABS INC |
Discontinued |
IRBESARTAN AND HYDROCHLOROTHIAZIDE |
203630 |
001 |
ANDA |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
TABLET;ORAL |
12.5MG;150MG |
No
|
No
|
2013/02/22
|
2013/02/22
|
AUROBINDO PHARMA LTD |
Prescription |
IRBESARTAN AND HYDROCHLOROTHIAZIDE |
203630 |
002 |
ANDA |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
TABLET;ORAL |
12.5MG;300MG |
No
|
No
|
2013/02/22
|
2013/02/22
|
AUROBINDO PHARMA LTD |
Prescription |
IRBESARTAN AND HYDROCHLOROTHIAZIDE |
203630 |
003 |
ANDA |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
TABLET;ORAL |
25MG;300MG |
No
|
No
|
2013/02/22
|
2016/03/31
|
AUROBINDO PHARMA LTD |
Prescription |
IRBESARTAN AND HYDROCHLOROTHIAZIDE |
201524 |
001 |
ANDA |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
TABLET;ORAL |
12.5MG;150MG |
No
|
No
|
2013/02/27
|
2013/02/27
|
LUPIN LTD |
Prescription |
IRBESARTAN AND HYDROCHLOROTHIAZIDE |
201524 |
001 |
ANDA |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
TABLET;ORAL |
12.5MG;150MG |
No
|
No
|
2013/02/27
(TA)
|
2013/02/27
|
LUPIN LTD |
Prescription |
IRBESARTAN AND HYDROCHLOROTHIAZIDE |
201524 |
002 |
ANDA |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
TABLET;ORAL |
12.5MG;300MG |
No
|
No
|
2013/02/27
|
2013/02/27
|
LUPIN LTD |
Prescription |
IRBESARTAN AND HYDROCHLOROTHIAZIDE |
201524 |
002 |
ANDA |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
TABLET;ORAL |
12.5MG;300MG |
No
|
No
|
2013/02/27
(TA)
|
2013/02/27
|
LUPIN LTD |
Prescription |
IRBESARTAN AND HYDROCHLOROTHIAZIDE |
203072 |
001 |
ANDA |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
TABLET;ORAL |
12.5MG;150MG |
No
|
No
|
2014/05/09
(TA)
|
2014/05/09
|
PRINSTON INC |
Prescription |
IRBESARTAN AND HYDROCHLOROTHIAZIDE |
203072 |
001 |
ANDA |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
TABLET;ORAL |
12.5MG;150MG |
No
|
No
|
2014/05/09
|
2014/05/09
|
PRINSTON INC |
Prescription |
IRBESARTAN AND HYDROCHLOROTHIAZIDE |
203072 |
002 |
ANDA |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
TABLET;ORAL |
12.5MG;300MG |
No
|
No
|
2014/05/09
(TA)
|
2014/05/09
|
PRINSTON INC |
Prescription |
IRBESARTAN AND HYDROCHLOROTHIAZIDE |
203072 |
002 |
ANDA |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
TABLET;ORAL |
12.5MG;300MG |
No
|
No
|
2014/05/09
|
2014/05/09
|
PRINSTON INC |
Prescription |
IRBESARTAN AND HYDROCHLOROTHIAZIDE |
203072 |
003 |
ANDA |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
TABLET;ORAL |
25MG/300MG |
No
|
No
|
2014/05/09
(TA)
|
--
|
PRINSTON INC |
None (Tentative Approval) |