Esomeprazole Magnesium

ANDA 209647, held by Amneal Pharms Ny. Esomeprazole Magnesium.

As of Nov 15, 2026, ANDA 209647 (Esomeprazole Magnesium), held by Amneal Pharms Ny, was first approved by FDA on Apr 10, 2019, with 4 approved supplements and 0 published complete response letters.

First approved: Apr 10, 2019
Review: Standard
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Apr 10, 2019	Original application	Approved	None posted

Products

2 strengths and forms


Esomeprazole MagnesiumEQ 20MG BASE · capsule, delayed rel pellets;oral	Esomeprazole Magnesium	Discontinued
Esomeprazole MagnesiumEQ 40MG BASE · capsule, delayed rel pellets;oral	Esomeprazole Magnesium	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Oct 4, 2024	Supplement 8Labeling · Standard review	Approved	None posted
May 22, 2023	Supplement 7Labeling · Standard review	Approved	None posted
May 22, 2023	Supplement 5Labeling · Standard review	Approved	None posted
May 22, 2023	Supplement 4Labeling · Standard review	Approved	None posted
Apr 10, 2019	Original application	Approved	None posted

Identifiers

Application: ANDA 209647
Drugs@FDA: Overview at FDA
Company: Amneal Pharmaceuticals of New York

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