Orange Book product · Generic (ANDA)
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
ESOMEPRAZOLE MAGNESIUM; NAPROXEN
At a glance
Jul 20, 2021
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 20, 2021
5 yr ago
Today
Pharmaceutical detail
Active ingredient
ESOMEPRAZOLE MAGNESIUM; NAPROXEN
Strength
EQ 20MG BASE;375MG
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
TE code
Not listed
Application
ANDA 204920
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of ESOMEPRAZOLE MAGNESIUM; NAPROXEN
- 2010VIMOVOBrand (NDA)
NDA 022511 · HORIZON
- 2023NAPROXEN AND ESOMEPRAZOLE MAGNESIUMGeneric (ANDA)
ANDA 217738 · SCIEGEN PHARMS
- 2022NAPROXEN AND ESOMEPRAZOLE MAGNESIUMGeneric (ANDA)
ANDA 213699 · AJANTA PHARMA LTD
- 2022NAPROXEN AND ESOMEPRAZOLE MAGNESIUMGeneric (ANDA)
ANDA 204470 · ACTAVIS LABS FL INC
- 2020NAPROXEN AND ESOMEPRAZOLE MAGNESIUMGeneric (ANDA)
ANDA 204206 · DR REDDYS
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
