ANDA 211571, held by Dr Reddys. Esomeprazole Magnesium.
As of Nov 15, 2026, ANDA 211571 (Esomeprazole Magnesium), held by Dr Reddys, was first approved by FDA on May 14, 2020, with 0 approved supplements and 0 published complete response letters.
Uses treats frequent heartburn (occurs 2 or more days a week) not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 14, 2020 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Esomeprazole MagnesiumEQ 20MG BASE · tablet, delayed release;oral | Esomeprazole Magnesium | OTC |
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
