ANDA 212866, held by Sun Pharm. Esomeprazole Magnesium.
As of Nov 15, 2026, ANDA 212866 (Esomeprazole Magnesium), held by Sun Pharm, was first approved by FDA on May 4, 2020, 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 |
|---|---|---|---|
| May 4, 2020 | 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
