GLIPIZIDE |
202298 |
001 |
ANDA |
GLIPIZIDE |
TABLET, EXTENDED RELEASE;ORAL |
2.5MG |
No
|
No
|
2015/05/19
|
2015/05/19
|
MYLAN |
Discontinued |
GLIPIZIDE |
202298 |
002 |
ANDA |
GLIPIZIDE |
TABLET, EXTENDED RELEASE;ORAL |
5MG |
No
|
No
|
2015/05/19
|
2015/05/19
|
MYLAN |
Discontinued |
GLIPIZIDE |
202298 |
003 |
ANDA |
GLIPIZIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MG |
No
|
No
|
2015/05/19
|
2015/05/19
|
MYLAN |
Discontinued |
CHLOROTHIAZIDE SODIUM |
202462 |
001 |
ANDA |
CHLOROTHIAZIDE SODIUM |
INJECTABLE;INJECTION |
EQ 500MG BASE/VIAL |
No
|
Yes
|
2015/05/29
|
2015/05/29
|
SAGENT PHARMS INC |
Prescription |
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE |
201087 |
001 |
ANDA |
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN |
TABLET;ORAL |
EQ 5MG BASE;12.5MG;160MG |
No
|
No
|
2015/06/01
|
2015/06/01
|
STRIDES PHARMA |
Prescription |
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE |
201087 |
002 |
ANDA |
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN |
TABLET;ORAL |
EQ 5MG BASE;25MG;160MG |
No
|
No
|
2015/06/01
|
2015/06/01
|
STRIDES PHARMA |
Prescription |
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE |
201087 |
003 |
ANDA |
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN |
TABLET;ORAL |
EQ 10MG BASE;12.5MG;160MG |
No
|
No
|
2015/06/01
|
2015/06/01
|
STRIDES PHARMA |
Prescription |
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE |
201087 |
004 |
ANDA |
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN |
TABLET;ORAL |
EQ 10MG BASE;25MG;160MG |
No
|
No
|
2015/06/01
|
2015/06/01
|
STRIDES PHARMA |
Prescription |
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE |
201087 |
005 |
ANDA |
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN |
TABLET;ORAL |
EQ 10MG BASE;25MG;320MG |
No
|
No
|
2015/06/01
|
2015/06/01
|
STRIDES PHARMA |
Prescription |
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE |
200797 |
001 |
ANDA |
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN |
TABLET;ORAL |
EQ 5MG BASE;12.5MG;160MG |
No
|
No
|
2015/06/03
|
2015/06/03
|
LUPIN LTD |
Prescription |
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE |
200797 |
002 |
ANDA |
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN |
TABLET;ORAL |
EQ 5MG BASE;25MG;160MG |
No
|
No
|
2015/06/03
|
2015/06/03
|
LUPIN LTD |
Prescription |
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE |
200797 |
003 |
ANDA |
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN |
TABLET;ORAL |
EQ 10MG BASE;12.5MG;160MG |
No
|
No
|
2015/06/03
|
2015/06/03
|
LUPIN LTD |
Prescription |
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE |
200797 |
004 |
ANDA |
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN |
TABLET;ORAL |
EQ 10MG BASE;25MG;160MG |
No
|
No
|
2015/06/03
|
2015/06/03
|
LUPIN LTD |
Prescription |
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE |
200797 |
005 |
ANDA |
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN |
TABLET;ORAL |
EQ 10MG BASE;25MG;320MG |
No
|
No
|
2015/06/03
|
2015/06/03
|
LUPIN LTD |
Prescription |
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE |
201593 |
001 |
ANDA |
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN |
TABLET;ORAL |
EQ 5MG BASE;12.5MG;160MG |
No
|
No
|
2015/06/03
|
2015/06/03
|
TORRENT |
Discontinued |
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE |
201593 |
002 |
ANDA |
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN |
TABLET;ORAL |
EQ 5MG BASE;25MG;160MG |
No
|
No
|
2015/06/03
|
2015/06/03
|
TORRENT |
Discontinued |
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE |
201593 |
003 |
ANDA |
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN |
TABLET;ORAL |
EQ 10MG BASE;12.5MG;160MG |
No
|
No
|
2015/06/03
|
2015/06/03
|
TORRENT |
Discontinued |
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE |
201593 |
004 |
ANDA |
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN |
TABLET;ORAL |
EQ 10MG BASE;25MG;160MG |
No
|
No
|
2015/06/03
|
2015/06/03
|
TORRENT |
Discontinued |
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE |
201593 |
005 |
ANDA |
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN |
TABLET;ORAL |
EQ 10MG BASE;25MG;320MG |
No
|
No
|
2015/06/03
|
2015/06/03
|
TORRENT |
Discontinued |
BALSALAZIDE DISODIUM |
206909 |
001 |
ANDA |
BALSALAZIDE DISODIUM |
TABLET;ORAL |
1.1G |
No
|
No
|
2015/09/01
(TA)
|
--
|
MYLAN PHARMS INC |
None (Tentative Approval) |