Orange Book product · Brand (NDA)
VIMOVO
ESOMEPRAZOLE MAGNESIUM; NAPROXEN
At a glance
Apr 30, 2010
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 30, 2010
16 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
ESOMEPRAZOLE MAGNESIUM; NAPROXEN
Strength
EQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 022511
Product number
002
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 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
- 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.
