ANDA 217264, held by Pharmazone. Esomeprazole Magnesium.
As of Nov 15, 2026, ANDA 217264 (Esomeprazole Magnesium), held by Pharmazone, was first approved by FDA on Sep 29, 2023, with 2 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 |
|---|---|---|---|
| Sep 29, 2023 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Esomeprazole MagnesiumEQ 20MG BASE · capsule, delayed release;oral | Esomeprazole Magnesium | OTC |
| May 20, 2026 | Supplement 4Manufacturing | Approved | None posted |
| Apr 17, 2026 | Supplement 3Manufacturing | Approved | None posted |
| Sep 29, 2023 | Original application | Approved | None posted |
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
