ANDA 218829, held by Pharmazone. Omeprazole Magnesium.
As of Nov 15, 2026, ANDA 218829 (Omeprazole Magnesium), held by Pharmazone, was first approved by FDA on Aug 7, 2025, with 1 approved supplement 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 |
|---|---|---|---|
| Aug 7, 2025 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Omeprazole MagnesiumEQ 20MG BASE · tablet, delayed release;oral | Omeprazole Magnesium | OTC |
| Jun 29, 2026 | Supplement 2Manufacturing | Approved | None posted |
| Aug 7, 2025 | 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
