ANDA 213201, held by Aurobindo Pharma Ltd. Omeprazole Magnesium.
As of Nov 15, 2026, ANDA 213201 (Omeprazole Magnesium), held by Aurobindo Pharma Ltd, was first approved by FDA on Apr 28, 2023, with 0 approved supplements and 0 published complete response letters.
Use 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 |
|---|---|---|---|
| Apr 28, 2023 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Omeprazole MagnesiumEQ 20MG BASE · capsule, delayed release;oral | Omeprazole 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
