Esomeprazole Magnesium

Treats heartburn and other symptoms associated with GERD. ANDA 78936, held by Mylan. Esomeprazole Magnesium.

As of Nov 15, 2026, ANDA 78936 (Esomeprazole Magnesium), held by Mylan, was first approved by FDA on Aug 3, 2015, with 5 approved supplements and 0 published complete response letters.

First approved: Aug 3, 2015
Supplements approved: 5
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the:

Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age.
Maintenance of healing of EE in adults.
Short-term treatment of heartburn and other symptoms associated with GERD in adults and pediatric patients 12 years to 17 years of age.
Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Aug 3, 2015	Original application	Approved	Letter Label Letter

Products

2 strengths and forms


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

All 6 submissions, including labeling and manufacturing supplements


Nov 12, 2024	Supplement 19Labeling · Standard review	Approved	None posted
Oct 5, 2023	Supplement 6Labeling · Standard review	Approved	None posted
Oct 5, 2023	Supplement 7Labeling · Standard review	Approved	None posted
Oct 5, 2023	Supplement 9Labeling · Standard review	Approved	None posted
Oct 5, 2023	Supplement 12Labeling · Standard review	Approved	None posted
Aug 3, 2015	Original application	Approved	Letter Label Letter

Identifiers

Application: ANDA 78936
Drugs@FDA: Overview at FDA
Company: Mylan

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