Orange Book product · Generic (ANDA)
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
ESOMEPRAZOLE MAGNESIUM; NAPROXEN
At a glance
Aug 24, 2022
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 24, 2022
3 yr 11 mo 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 204470
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
- 2021NAPROXEN AND ESOMEPRAZOLE MAGNESIUMGeneric (ANDA)
ANDA 204920 · PHARMOBEDIENT
- 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.
