| ESOMEPRAZOLE MAGNESIUM |
216349 |
001 |
ANDA |
ESOMEPRAZOLE MAGNESIUM |
CAPSULE, DELAYED RELEASE;ORAL |
EQ 20MG BASE |
No
|
No
|
2022/06/24
|
2022/06/24
|
GRAVITI PHARMS |
Over-the-counter |
| NAPROXEN AND ESOMEPRAZOLE MAGNESIUM |
204470 |
001 |
ANDA |
ESOMEPRAZOLE MAGNESIUM; NAPROXEN |
TABLET, DELAYED RELEASE;ORAL |
EQ 20MG BASE;375MG |
No
|
No
|
2022/08/24
|
2022/08/24
|
ACTAVIS LABS FL INC |
Discontinued |
| NAPROXEN AND ESOMEPRAZOLE MAGNESIUM |
204470 |
002 |
ANDA |
ESOMEPRAZOLE MAGNESIUM; NAPROXEN |
TABLET, DELAYED RELEASE;ORAL |
EQ 20MG BASE;500MG |
No
|
No
|
2022/08/24
|
2022/08/24
|
ACTAVIS LABS FL INC |
Discontinued |
| NAPROXEN AND ESOMEPRAZOLE MAGNESIUM |
213699 |
001 |
ANDA |
ESOMEPRAZOLE MAGNESIUM; NAPROXEN |
TABLET, DELAYED RELEASE;ORAL |
EQ 20MG BASE;375MG |
No
|
No
|
2022/10/06
|
2022/10/06
|
AJANTA PHARMA LTD |
Prescription |
| NAPROXEN AND ESOMEPRAZOLE MAGNESIUM |
213699 |
002 |
ANDA |
ESOMEPRAZOLE MAGNESIUM; NAPROXEN |
TABLET, DELAYED RELEASE;ORAL |
EQ 20MG BASE;500MG |
No
|
No
|
2022/10/06
|
2022/10/06
|
AJANTA PHARMA LTD |
Prescription |
| ASPIRIN; OMEPRAZOLE |
209791 |
001 |
ANDA |
ASPIRIN;OMEPRAZOLE |
TABLET;ORAL |
81MG;40MG |
No
|
No
|
2023/01/20
(TA)
|
--
|
TEVA PHARMS USA INC |
None (Tentative Approval) |
| ASPIRIN; OMEPRAZOLE |
209791 |
002 |
ANDA |
ASPIRIN;OMEPRAZOLE |
TABLET;ORAL |
325MG;40MG |
No
|
No
|
2023/01/20
(TA)
|
--
|
TEVA PHARMS USA INC |
None (Tentative Approval) |
| ESOMEPRAZOLE MAGNESIUM |
216149 |
001 |
ANDA |
ESOMEPRAZOLE MAGNESIUM |
CAPSULE, DELAYED RELEASE;ORAL |
EQ 20MG BASE |
No
|
No
|
2023/03/15
|
2023/03/15
|
GUARDIAN DRUG |
Over-the-counter |
| ESOMEPRAZOLE MAGNESIUM |
214920 |
001 |
ANDA |
ESOMEPRAZOLE MAGNESIUM |
CAPSULE, DELAYED REL PELLETS;ORAL |
EQ 20MG BASE |
No
|
No
|
2023/03/28
|
2023/03/28
|
PRINSTON INC |
Prescription |
| ESOMEPRAZOLE MAGNESIUM |
214920 |
002 |
ANDA |
ESOMEPRAZOLE MAGNESIUM |
CAPSULE, DELAYED REL PELLETS;ORAL |
EQ 40MG BASE |
No
|
No
|
2023/03/28
|
2023/03/28
|
PRINSTON INC |
Prescription |
| OMEPRAZOLE MAGNESIUM |
213201 |
001 |
ANDA |
OMEPRAZOLE MAGNESIUM |
CAPSULE, DELAYED RELEASE;ORAL |
EQ 20MG BASE |
No
|
No
|
2023/04/28
|
2023/04/28
|
AUROBINDO PHARMA LTD |
Discontinued |
| ESOMEPRAZOLE MAGNESIUM |
206055 |
001 |
ANDA |
ESOMEPRAZOLE MAGNESIUM |
FOR SUSPENSION, DELAYED RELEASE;ORAL |
EQ 20MG BASE/PACKET |
No
|
No
|
2023/06/07
|
2023/06/07
|
ZYDUS PHARMS |
Prescription |
| ESOMEPRAZOLE MAGNESIUM |
206055 |
002 |
ANDA |
ESOMEPRAZOLE MAGNESIUM |
FOR SUSPENSION, DELAYED RELEASE;ORAL |
EQ 40MG BASE/PACKET |
No
|
No
|
2023/06/07
|
2023/06/07
|
ZYDUS PHARMS |
Prescription |
| ESOMEPRAZOLE MAGNESIUM |
214473 |
001 |
ANDA |
ESOMEPRAZOLE MAGNESIUM |
TABLET, DELAYED RELEASE;ORAL |
EQ 20MG BASE |
No
|
No
|
2023/07/12
|
2023/07/12
|
AUROBINDO PHARMA LTD |
Discontinued |
| NAPROXEN AND ESOMEPRAZOLE MAGNESIUM |
217738 |
001 |
ANDA |
ESOMEPRAZOLE MAGNESIUM; NAPROXEN |
TABLET, DELAYED RELEASE;ORAL |
EQ 20MG BASE;375MG |
No
|
No
|
2023/10/11
|
2023/10/11
|
SCIEGEN PHARMS INC |
Prescription |
| NAPROXEN AND ESOMEPRAZOLE MAGNESIUM |
217738 |
002 |
ANDA |
ESOMEPRAZOLE MAGNESIUM; NAPROXEN |
TABLET, DELAYED RELEASE;ORAL |
EQ 20MG BASE;500MG |
No
|
No
|
2023/10/11
|
2023/10/11
|
SCIEGEN PHARMS INC |
Prescription |
| ESOMEPRAZOLE MAGNESIUM |
217427 |
001 |
ANDA |
ESOMEPRAZOLE MAGNESIUM |
CAPSULE, DELAYED REL PELLETS;ORAL |
EQ 20MG BASE |
No
|
No
|
2023/10/18
|
2023/10/18
|
GRANULES |
Prescription |
| ESOMEPRAZOLE MAGNESIUM |
217427 |
002 |
ANDA |
ESOMEPRAZOLE MAGNESIUM |
CAPSULE, DELAYED REL PELLETS;ORAL |
EQ 40MG BASE |
No
|
No
|
2023/10/18
|
2023/10/18
|
GRANULES |
Prescription |
| ESOMEPRAZOLE MAGNESIUM |
217022 |
001 |
ANDA |
ESOMEPRAZOLE MAGNESIUM |
CAPSULE, DELAYED REL PELLETS;ORAL |
EQ 20MG BASE |
No
|
No
|
2023/12/27
|
2023/12/27
|
ZHEJIANG YONGTAI |
Prescription |
| ESOMEPRAZOLE MAGNESIUM |
217022 |
002 |
ANDA |
ESOMEPRAZOLE MAGNESIUM |
CAPSULE, DELAYED REL PELLETS;ORAL |
EQ 40MG BASE |
No
|
No
|
2023/12/27
|
2023/12/27
|
ZHEJIANG YONGTAI |
Prescription |