Esomeprazole Magnesium

ANDA 209339, held by Aurobindo Pharma. Esomeprazole Magnesium.

As of Nov 15, 2026, ANDA 209339 (Esomeprazole Magnesium), held by Aurobindo Pharma, was first approved by FDA on Oct 16, 2017, with 3 approved supplements and 0 published complete response letters.

First approved: Oct 16, 2017
Review: Standard
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

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

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Oct 16, 2017	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Esomeprazole MagnesiumEQ 20MG BASE · capsule, delayed release;oral	Esomeprazole Magnesium	OTC

All 4 submissions, including labeling and manufacturing supplements


Nov 20, 2023	Supplement 13Manufacturing	Approved	None posted
Jan 15, 2020	Supplement 2Labeling · Standard review	Approved	None posted
Jan 15, 2020	Supplement 6Labeling · Standard review	Approved	None posted
Oct 16, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 209339
Drugs@FDA: Overview at FDA
Company: Aurobindo Pharma

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