ANDA 207673, held by Dr Reddys. Esomeprazole Magnesium.
As of Nov 15, 2026, ANDA 207673 (Esomeprazole Magnesium), held by Dr Reddys, was first approved by FDA on May 15, 2018, with 1 approved supplement and 0 published complete response letters.
Use(s) 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 15, 2018 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Esomeprazole MagnesiumEQ 20MG BASE · capsule, delayed release;oral | Esomeprazole Magnesium | OTC |
| Jan 21, 2020 | Supplement 3Labeling · Standard review | Approved | None posted |
| May 15, 2018 | 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
