ANDA 216149, held by Guardian Drug. Esomeprazole Magnesium.
As of Nov 15, 2026, ANDA 216149 (Esomeprazole Magnesium), held by Guardian Drug, was first approved by FDA on Mar 15, 2023, with 0 approved supplements and 0 published complete response letters.
USE(S) 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 |
|---|---|---|---|
| Mar 15, 2023 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Esomeprazole MagnesiumEQ 20MG BASE · capsule, 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
