Omeprazole Magnesium

ANDA 204152, held by Perrigo R And D. Omeprazole Magnesium.

As of Nov 15, 2026, ANDA 204152 (Omeprazole Magnesium), held by Perrigo R And D, was first approved by FDA on Jul 30, 2015, with 5 approved supplements and 0 published complete response letters.

First approved: Jul 30, 2015
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

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

Date	Submission	Status	Documents
Jul 30, 2015	Original application	Approved	Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Omeprazole MagnesiumEQ 20MG BASE · tablet, delayed release;oral	Omeprazole Magnesium	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Jun 25, 2026	Supplement 6Labeling · Standard review	Approved	None posted
Jun 25, 2026	Supplement 8Labeling · Standard review	Approved	None posted
Jun 25, 2026	Supplement 10Labeling · Standard review	Approved	None posted
May 4, 2018	Supplement 5Manufacturing	Approved	None posted
Apr 28, 2016	Supplement 1Labeling · Standard review	Approved	None posted
Jul 30, 2015	Original application	Approved	Letter

Identifiers

Application: ANDA 204152
Drugs@FDA: Overview at FDA
Company: Perrigo R&D

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