| OMEPRAZOLE AND SODIUM BICARBONATE |
203290 |
001 |
ANDA |
OMEPRAZOLE; SODIUM BICARBONATE |
CAPSULE;ORAL |
20MG;1.1GM |
No
|
No
|
2018/05/25
|
2018/05/25
|
ZYDUS PHARMS |
Prescription |
| OMEPRAZOLE AND SODIUM BICARBONATE |
203290 |
002 |
ANDA |
OMEPRAZOLE; SODIUM BICARBONATE |
CAPSULE;ORAL |
40MG;1.1GM |
No
|
No
|
2018/05/25
|
2018/05/25
|
ZYDUS PHARMS |
Prescription |
| OMEPRAZOLE MAGNESIUM |
206877 |
001 |
ANDA |
OMEPRAZOLE MAGNESIUM |
TABLET, DELAYED RELEASE;ORAL |
EQ 20MG BASE |
No
|
No
|
2018/06/06
|
2018/06/06
|
AUROBINDO PHARMA |
Over-the-counter |
| OMEPRAZOLE |
205070 |
001 |
ANDA |
OMEPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
10MG |
No
|
No
|
2018/06/29
|
2018/06/29
|
MYLAN |
Discontinued |
| OMEPRAZOLE |
205070 |
002 |
ANDA |
OMEPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
20MG |
No
|
No
|
2018/06/29
|
2018/06/29
|
MYLAN |
Discontinued |
| OMEPRAZOLE |
205070 |
003 |
ANDA |
OMEPRAZOLE |
CAPSULE, DELAYED REL PELLETS;ORAL |
40MG |
No
|
No
|
2018/06/29
|
2018/06/29
|
MYLAN |
Discontinued |
| OMEPRAZOLE MAGNESIUM |
210593 |
001 |
ANDA |
OMEPRAZOLE MAGNESIUM |
CAPSULE, DELAYED RELEASE;ORAL |
EQ 20MG BASE |
No
|
No
|
2018/07/20
|
2018/07/20
|
SPIL |
Over-the-counter |
| NAPROXEN AND ESOMEPRAZOLE MAGNESIUM |
202461 |
001 |
ANDA |
ESOMEPRAZOLE MAGNESIUM; NAPROXEN |
TABLET, DELAYED RELEASE;ORAL |
EQ 20MG BASE;375MG |
No
|
No
|
2018/09/04
(TA)
|
--
|
DR REDDYS LABS LTD |
None (Tentative Approval) |
| NAPROXEN AND ESOMEPRAZOLE MAGNESIUM |
202461 |
002 |
ANDA |
ESOMEPRAZOLE MAGNESIUM; NAPROXEN |
TABLET, DELAYED RELEASE;ORAL |
EQ 20MG BASE;500MG |
No
|
No
|
2018/09/04
(TA)
|
--
|
DR REDDYS LABS LTD |
None (Tentative Approval) |
| OMEPRAZOLE |
207891 |
001 |
ANDA |
OMEPRAZOLE |
TABLET, DELAYED RELEASE;ORAL |
20MG |
No
|
No
|
2018/10/12
|
2018/10/12
|
SUN PHARM |
Over-the-counter |
| OMEPRAZOLE |
207740 |
001 |
ANDA |
OMEPRAZOLE |
TABLET, DELAYED RELEASE;ORAL |
20MG |
No
|
No
|
2018/11/05
|
2018/11/05
|
DR REDDYS |
Over-the-counter |
| OMEPRAZOLE |
210070 |
001 |
ANDA |
OMEPRAZOLE |
TABLET, DELAYED RELEASE;ORAL |
20MG |
No
|
No
|
2019/02/11
|
2019/02/11
|
APOTEX |
Over-the-counter |
| ESOMEPRAZOLE MAGNESIUM |
209202 |
001 |
ANDA |
ESOMEPRAZOLE MAGNESIUM |
TABLET, DELAYED RELEASE;ORAL |
EQ 20MG BASE |
No
|
No
|
2019/03/05
|
2019/03/05
|
P AND L |
Discontinued |
| ESOMEPRAZOLE MAGNESIUM |
209647 |
001 |
ANDA |
ESOMEPRAZOLE MAGNESIUM |
CAPSULE, DELAYED REL PELLETS;ORAL |
EQ 20MG BASE |
No
|
No
|
2019/04/10
|
2019/04/10
|
AMNEAL PHARMS NY |
Discontinued |
| ESOMEPRAZOLE MAGNESIUM |
209647 |
002 |
ANDA |
ESOMEPRAZOLE MAGNESIUM |
CAPSULE, DELAYED REL PELLETS;ORAL |
EQ 40MG BASE |
No
|
No
|
2019/04/10
|
2019/04/10
|
AMNEAL PHARMS NY |
Discontinued |
| ESOMEPRAZOLE MAGNESIUM |
209495 |
001 |
ANDA |
ESOMEPRAZOLE MAGNESIUM |
CAPSULE, DELAYED REL PELLETS;ORAL |
EQ 20MG BASE |
No
|
No
|
2019/05/10
|
2019/05/10
|
GLENMARK SPECLT |
Prescription |
| ESOMEPRAZOLE MAGNESIUM |
209495 |
002 |
ANDA |
ESOMEPRAZOLE MAGNESIUM |
CAPSULE, DELAYED REL PELLETS;ORAL |
EQ 40MG BASE |
No
|
No
|
2019/05/10
|
2019/05/10
|
GLENMARK SPECLT |
Prescription |
| ESOMEPRAZOLE MAGNESIUM |
206296 |
001 |
ANDA |
ESOMEPRAZOLE MAGNESIUM |
CAPSULE, DELAYED REL PELLETS;ORAL |
EQ 20MG BASE |
No
|
No
|
2019/05/22
|
2019/05/22
|
ZYDUS PHARMS |
Prescription |
| ESOMEPRAZOLE MAGNESIUM |
206296 |
002 |
ANDA |
ESOMEPRAZOLE MAGNESIUM |
CAPSULE, DELAYED REL PELLETS;ORAL |
EQ 40MG BASE |
No
|
No
|
2019/05/22
|
2019/05/22
|
ZYDUS PHARMS |
Prescription |
| ESOMEPRAZOLE MAGNESIUM |
209716 |
001 |
ANDA |
ESOMEPRAZOLE MAGNESIUM |
CAPSULE, DELAYED RELEASE;ORAL |
EQ 20MG BASE |
No
|
No
|
2019/06/05
|
2019/06/05
|
AMNEAL PHARMS NY |
Over-the-counter |