| OMEPRAZOLE |
075347 |
001 |
ANDA |
OMEPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
10MG |
No
|
No
|
2008/05/30
|
2008/05/30
|
ACTAVIS LABS FL INC |
Prescription |
| OMEPRAZOLE |
075347 |
002 |
ANDA |
OMEPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
20MG |
No
|
No
|
2008/05/30
|
2008/05/30
|
ACTAVIS LABS FL INC |
Prescription |
| OMEPRAZOLE |
075347 |
003 |
ANDA |
OMEPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
40MG |
No
|
No
|
2008/05/30
|
2008/05/30
|
ACTAVIS LABS FL INC |
Prescription |
| OMEPRAZOLE |
076515 |
001 |
ANDA |
OMEPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
40MG |
No
|
Yes
|
2009/01/21
|
2009/01/21
|
SANDOZ |
Prescription |
| OMEPRAZOLE |
078490 |
001 |
ANDA |
OMEPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
40MG |
No
|
No
|
2009/04/17
|
2009/04/17
|
DR REDDYS LABS LTD |
Prescription |
| OMEPRAZOLE |
078490 |
002 |
ANDA |
OMEPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
10MG |
No
|
No
|
2009/04/17
|
2009/03/16
|
DR REDDYS LABS LTD |
Prescription |
| OMEPRAZOLE |
078490 |
003 |
ANDA |
OMEPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
20MG |
No
|
No
|
2009/04/17
|
2009/03/16
|
DR REDDYS LABS LTD |
Prescription |
| OMEPRAZOLE MAGNESIUM |
078878 |
001 |
ANDA |
OMEPRAZOLE MAGNESIUM |
CAPSULE, DELAYED RELEASE;ORAL |
EQ 20MG BASE |
No
|
Yes
|
2009/06/05
|
2009/06/05
|
DR REDDYS LABS LTD |
Over-the-counter |
| MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE |
022456 |
001 |
NDA |
MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE |
TABLET;ORAL |
343MG;20MG;750MG |
No
|
No
|
2009/12/04
|
2009/12/04
|
SANTARUS |
Discontinued |
| MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE |
022456 |
002 |
NDA |
MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE |
TABLET;ORAL |
343MG;40MG;750MG |
No
|
No
|
2009/12/04
|
2009/12/04
|
SANTARUS |
Discontinued |
| OMEPRAZOLE AND SODIUM BICARBONATE |
078966 |
001 |
ANDA |
OMEPRAZOLE; SODIUM BICARBONATE |
CAPSULE;ORAL |
20MG;1.1GM |
No
|
No
|
2010/05/25
|
2010/05/25
|
STRIDES PHARMA |
Discontinued |
| OMEPRAZOLE AND SODIUM BICARBONATE |
078966 |
002 |
ANDA |
OMEPRAZOLE; SODIUM BICARBONATE |
CAPSULE;ORAL |
40MG;1.1GM |
No
|
No
|
2010/05/25
|
2010/05/25
|
STRIDES PHARMA |
Discontinued |
| OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN |
050824 |
001 |
NDA |
AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE |
CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL |
500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
Yes
|
No
|
2011/02/08
|
2011/02/08
|
CUMBERLAND |
Discontinued |
| OMEPRAZOLE |
091352 |
001 |
ANDA |
OMEPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
10MG |
No
|
No
|
2012/11/19
|
2012/11/19
|
ZYDUS PHARMS USA INC |
Prescription |
| OMEPRAZOLE |
091352 |
002 |
ANDA |
OMEPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
20MG |
No
|
No
|
2012/11/19
|
2012/11/19
|
ZYDUS PHARMS USA INC |
Prescription |
| OMEPRAZOLE |
091352 |
003 |
ANDA |
OMEPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
40MG |
No
|
No
|
2012/11/19
|
2012/11/19
|
ZYDUS PHARMS USA INC |
Prescription |
| ESOMEPRAZOLE SODIUM |
200882 |
001 |
ANDA |
ESOMEPRAZOLE SODIUM |
INJECTABLE;INTRAVENOUS |
EQ 20MG BASE/VIAL |
No
|
No
|
2013/03/18
|
2013/03/18
|
SUN PHARM |
Discontinued |
| ESOMEPRAZOLE SODIUM |
200882 |
002 |
ANDA |
ESOMEPRAZOLE SODIUM |
INJECTABLE;INTRAVENOUS |
EQ 40MG BASE/VIAL |
No
|
No
|
2013/03/18
|
2013/03/18
|
SUN PHARM |
Prescription |
| OMEPRAZOLE AND SODIUM BICARBONATE |
079182 |
001 |
ANDA |
OMEPRAZOLE; SODIUM BICARBONATE |
FOR SUSPENSION;ORAL |
20MG/PACKET;1.68GM/PACKET |
No
|
No
|
2013/04/19
|
2013/04/19
|
STRIDES PHARMA |
Prescription |
| OMEPRAZOLE AND SODIUM BICARBONATE |
079182 |
002 |
ANDA |
OMEPRAZOLE; SODIUM BICARBONATE |
FOR SUSPENSION;ORAL |
40MG/PACKET;1.68GM/PACKET |
No
|
No
|
2013/04/19
|
2013/04/19
|
STRIDES PHARMA |
Prescription |