ANDA 218092, held by Glenmark Speclt. Esomeprazole Magnesium.
As of Nov 15, 2026, ANDA 218092 (Esomeprazole Magnesium), held by Glenmark Speclt, was first approved by FDA on Jun 11, 2024, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 11, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Esomeprazole MagnesiumEQ 20MG BASE ยท 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
