| AMLODIPINE BESYLATE |
201380 |
001 |
ANDA |
AMLODIPINE BESYLATE |
TABLET;ORAL |
EQ 5MG BASE |
No
|
No
|
2012/04/13
|
2012/04/13
|
GRAVITI PHARMS |
Discontinued |
| AMLODIPINE BESYLATE |
201380 |
002 |
ANDA |
AMLODIPINE BESYLATE |
TABLET;ORAL |
EQ 10MG BASE |
No
|
No
|
2012/04/13
|
2012/04/13
|
GRAVITI PHARMS |
Discontinued |
| AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE |
202239 |
001 |
ANDA |
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 2.5MG BASE;10MG |
No
|
No
|
2012/09/05
|
2012/09/05
|
AUROBINDO PHARMA LTD |
Prescription |
| AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE |
202239 |
002 |
ANDA |
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 5MG BASE;10MG |
No
|
No
|
2012/09/05
|
2012/09/05
|
AUROBINDO PHARMA LTD |
Prescription |
| AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE |
202239 |
003 |
ANDA |
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 5MG BASE;20MG |
No
|
No
|
2012/09/05
|
2012/09/05
|
AUROBINDO PHARMA LTD |
Prescription |
| AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE |
202239 |
004 |
ANDA |
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 5MG BASE;40MG |
No
|
No
|
2012/09/05
|
2012/09/05
|
AUROBINDO PHARMA LTD |
Prescription |
| AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE |
202239 |
005 |
ANDA |
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 10MG BASE;20MG |
No
|
No
|
2012/09/05
|
2012/09/05
|
AUROBINDO PHARMA LTD |
Prescription |
| AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE |
202239 |
006 |
ANDA |
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 10MG BASE;40MG |
No
|
No
|
2012/09/05
|
2012/09/05
|
AUROBINDO PHARMA LTD |
Prescription |
| AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE |
200435 |
001 |
ANDA |
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN |
TABLET;ORAL |
EQ 5MG BASE;12.5MG;160MG |
No
|
No
|
2012/09/25
|
2012/09/25
|
TEVA PHARMS |
Discontinued |
| AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE |
200435 |
002 |
ANDA |
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN |
TABLET;ORAL |
EQ 5MG BASE;25MG;160MG |
No
|
No
|
2012/09/25
|
2012/09/25
|
TEVA PHARMS |
Discontinued |
| AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE |
200435 |
003 |
ANDA |
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN |
TABLET;ORAL |
EQ 10MG BASE;25MG;160MG |
No
|
No
|
2012/09/25
|
2012/09/25
|
TEVA PHARMS |
Discontinued |
| AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE |
200435 |
004 |
ANDA |
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN |
TABLET;ORAL |
EQ 10MG BASE;25MG;320MG |
No
|
No
|
2012/09/25
|
2012/09/25
|
TEVA PHARMS |
Discontinued |
| AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE |
200435 |
005 |
ANDA |
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN |
TABLET;ORAL |
EQ 10MG BASE;12.5MG;160MG |
No
|
No
|
2012/09/25
|
2012/09/25
|
TEVA PHARMS |
Discontinued |
| AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE |
078652 |
001 |
ANDA |
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE |
CAPSULE; ORAL |
2.5MG; 10MG |
No
|
No
|
2013/03/28
(TA)
|
--
|
ZYDUS PHARMS USA INC |
None (Tentative Approval) |
| AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE |
078652 |
002 |
ANDA |
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE |
CAPSULE; ORAL |
5MG; 10MG |
No
|
No
|
2013/03/28
(TA)
|
--
|
ZYDUS PHARMS USA INC |
None (Tentative Approval) |
| AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE |
078652 |
003 |
ANDA |
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE |
CAPSULE; ORAL |
5MG; 20MG |
No
|
No
|
2013/03/28
(TA)
|
--
|
ZYDUS PHARMS USA INC |
None (Tentative Approval) |
| AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE |
078652 |
004 |
ANDA |
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE |
CAPSULE; ORAL |
10MG; 20MG |
No
|
No
|
2013/03/28
(TA)
|
--
|
ZYDUS PHARMS USA INC |
None (Tentative Approval) |
| AMLODIPINE BESYLATE AND VALSARTAN |
090011 |
001 |
ANDA |
AMLODIPINE BESYLATE; VALSARTAN |
TABLET;ORAL |
EQ 5MG BASE;160MG |
No
|
No
|
2013/03/28
|
2013/03/28
|
STRIDES PHARMA INTL |
Prescription |
| AMLODIPINE BESYLATE AND VALSARTAN |
090011 |
002 |
ANDA |
AMLODIPINE BESYLATE; VALSARTAN |
TABLET;ORAL |
EQ 10MG BASE;160MG |
No
|
No
|
2013/03/28
|
2013/03/28
|
STRIDES PHARMA INTL |
Prescription |
| AMLODIPINE BESYLATE AND VALSARTAN |
090011 |
003 |
ANDA |
AMLODIPINE BESYLATE; VALSARTAN |
TABLET;ORAL |
EQ 5MG BASE;320MG |
No
|
No
|
2013/03/28
|
2013/03/28
|
STRIDES PHARMA INTL |
Prescription |