NDA 214278, held by Dexcel. Esomeprazole Magnesium.
As of Nov 14, 2026, NDA 214278 (Esomeprazole Magnesium), held by Dexcel, was first approved by FDA on Oct 20, 2020, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 20, 2020 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Esomeprazole MagnesiumEQ 20MG BASE · tablet, orally disintegrating, delayed release;oral | Esomeprazole Magnesium | DiscontinuedReference drug |
| May 11, 2022 | Supplement 2Labeling · Standard review | Approved | |
| Sep 7, 2021 | Supplement 1Labeling · Standard review | Approved | |
| Oct 20, 2020 | Original applicationNew dosage form · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
