| NAPROXEN SODIUM |
208363 |
001 |
ANDA |
NAPROXEN SODIUM |
CAPSULE;ORAL |
EQ 200MG BASE |
No
|
No
|
2018/03/15
|
2018/03/15
|
PURACAP PHARM LLC |
Over-the-counter |
| SUMATRIPTAN AND NAPROXEN SODIUM |
202803 |
001 |
ANDA |
NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE |
TABLET;ORAL |
500MG;EQ 85MG BASE |
No
|
No
|
2018/07/20
|
2018/07/20
|
SUN PHARM |
Prescription |
| SUMATRIPTAN AND NAPROXEN SODIUM |
090872 |
001 |
ANDA |
NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE |
TABLET;ORAL |
500MG;EQ 85MG BASE |
No
|
No
|
2018/09/04
|
2018/09/04
|
RISING |
Prescription |
| 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) |
| NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE |
209726 |
001 |
ANDA |
DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM |
TABLET;ORAL |
25MG;220MG |
No
|
No
|
2018/10/23
|
2018/10/23
|
AMNEAL PHARMS CO |
Over-the-counter |
| NAPROXEN SODIUM |
207612 |
001 |
ANDA |
NAPROXEN SODIUM |
TABLET;ORAL |
220MG |
No
|
No
|
2018/11/16
|
2018/11/16
|
NOVELGENIX THERAPS |
Over-the-counter |
| NAPROXEN SODIUM |
202807 |
001 |
ANDA |
NAPROXEN SODIUM |
CAPSULE;ORAL |
EQ 200MG BASE |
No
|
No
|
2019/01/04
|
2019/01/04
|
CATALENT |
Over-the-counter |
| NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE |
207597 |
001 |
ANDA |
DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM |
TABLET;ORAL |
25MG;220MG |
No
|
No
|
2019/01/25
|
2019/01/25
|
P AND L |
Discontinued |
| NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE |
208499 |
001 |
ANDA |
DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM |
TABLET;ORAL |
25MG;220MG |
No
|
No
|
2019/05/10
|
2019/05/10
|
PERRIGO R AND D |
Over-the-counter |
| NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE |
211830 |
001 |
ANDA |
DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM |
TABLET;ORAL |
25MG;220MG |
No
|
No
|
2019/08/22
|
2019/08/22
|
COREPHARMA |
Over-the-counter |
| NAPROXEN SODIUM |
212033 |
001 |
ANDA |
NAPROXEN SODIUM |
TABLET;ORAL |
220MG |
No
|
No
|
2019/08/30
|
2019/08/30
|
YICHANG HUMANWELL |
Over-the-counter |
| NAPROXEN SODIUM |
212199 |
001 |
ANDA |
NAPROXEN SODIUM |
TABLET;ORAL |
EQ 250MG BASE |
No
|
No
|
2019/10/30
|
2019/10/30
|
SCIEGEN PHARMS INC |
Prescription |
| NAPROXEN SODIUM |
212199 |
002 |
ANDA |
NAPROXEN SODIUM |
TABLET;ORAL |
EQ 500MG BASE |
No
|
No
|
2019/10/30
|
2019/10/30
|
SCIEGEN PHARMS INC |
Prescription |
| NAPROXEN AND ESOMEPRAZOLE MAGNESIUM |
204206 |
001 |
ANDA |
ESOMEPRAZOLE MAGNESIUM; NAPROXEN |
TABLET, DELAYED RELEASE;ORAL |
EQ 20MG BASE;375MG |
No
|
No
|
2020/02/18
|
2020/02/18
|
DR REDDYS |
Prescription |
| NAPROXEN AND ESOMEPRAZOLE MAGNESIUM |
204206 |
002 |
ANDA |
ESOMEPRAZOLE MAGNESIUM; NAPROXEN |
TABLET, DELAYED RELEASE;ORAL |
EQ 20MG BASE;500MG |
No
|
Yes
|
2020/02/18
|
2020/02/18
|
DR REDDYS |
Prescription |
| NAPROXEN |
212517 |
001 |
ANDA |
NAPROXEN |
TABLET;ORAL |
250MG |
No
|
No
|
2020/02/21
|
2020/02/21
|
SCIEGEN PHARMS INC |
Prescription |
| NAPROXEN |
212517 |
002 |
ANDA |
NAPROXEN |
TABLET;ORAL |
375MG |
No
|
No
|
2020/02/21
|
2020/02/21
|
SCIEGEN PHARMS INC |
Prescription |
| NAPROXEN |
212517 |
003 |
ANDA |
NAPROXEN |
TABLET;ORAL |
500MG |
No
|
No
|
2020/02/21
|
2020/02/21
|
SCIEGEN PHARMS INC |
Prescription |
| NAPROXEN |
212705 |
001 |
ANDA |
NAPROXEN |
SUSPENSION;ORAL |
25MG/ML |
No
|
No
|
2020/07/31
|
2020/07/31
|
AMNEAL |
Prescription |