Sold as Vimovo. Every FDA application for this active ingredient: 1 branded and 6 generic.
As of Nov 15, 2026, FDA lists 7 applications for Esomeprazole Magnesium; Naproxen (sold as Vimovo), first approved Apr 30, 2010, with 1 new use approved and 0 published complete response letters.
| Apr 30, 2010 | VimovoNDA 22511 · New combination | Horizon | 26 | Discontinued |
| Feb 18, 2020 | Naproxen And Esomeprazole MagnesiumANDA 204206 | Dr Reddys | 6 | Marketed |
| Jul 20, 2021 | Naproxen And Esomeprazole MagnesiumANDA 204920 | Pharmobedient | 4 | Discontinued |
| Aug 24, 2022 | Naproxen And Esomeprazole MagnesiumANDA 204470 | Actavis Labs Fl Inc | 2 | Discontinued |
| Oct 6, 2022 | Naproxen And Esomeprazole MagnesiumANDA 213699 | Ajanta Pharma Ltd | 2 | Marketed |
| Oct 11, 2023 | Naproxen And Esomeprazole MagnesiumANDA 217738 | Sciegen Pharms | 1 | Marketed |
| — | Naproxen And Esomeprazole MagnesiumANDA 202461 | Dr Reddys Labs Ltd | 0 | Discontinued |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
