Prilosec Otc

NDA 21229, held by Astrazeneca. Omeprazole Magnesium.

As of Nov 15, 2026, NDA 21229 (Prilosec Otc), held by Astrazeneca, was first approved by FDA on Jun 20, 2003, with 24 approved supplements and 0 published complete response letters.

First approved: Jun 20, 2003
Review: Standard
Supplements approved: 24
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Use 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 25 submissions below

Date	Submission	Status	Documents
Jun 20, 2003	Original applicationTYPE 2/3 · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Prilosec OtcEQ 20MG BASE · tablet, delayed release;oral	Omeprazole Magnesium	OTCReference drug

All 25 submissions, including labeling and manufacturing supplements


Oct 4, 2022	Supplement 35Labeling · Standard review	Approved	Label Letter
Jan 30, 2020	Supplement 34Labeling · Standard review	Approved	Label Letter
Apr 4, 2019	Supplement 33Labeling · Standard review	Approved	Label Letter
Jun 12, 2018	Supplement 32Labeling · Standard review	Approved	Label Letter
Apr 3, 2018	Supplement 31Labeling · Standard review	Approved	Letter Label
Oct 12, 2016	Supplement 29Labeling · Standard review	Approved	Label Letter
Jun 22, 2015	Supplement 26Labeling · Standard review	Approved	Label Letter
May 15, 2014	Supplement 27Manufacturing · Standard review	Approved	None posted
Sep 6, 2013	Supplement 25Labeling · Standard review	Approved	Label Letter
Sep 13, 2012	Supplement 24Labeling · Standard review	Approved	Letter
Aug 29, 2011	Supplement 23Labeling	Approved	Label Letter
Jul 22, 2011	Supplement 21Labeling	Approved	Letter
Jun 20, 2011	Supplement 20Labeling	Approved	Letter
Jun 16, 2011	Supplement 22Manufacturing · Standard review	Approved	None posted
Feb 25, 2011	Supplement 19Labeling · Standard review	Approved	Letter
Dec 20, 2010	Supplement 17Labeling · Standard review	Approved	Letter
Jul 6, 2010	Supplement 14Labeling	Approved	Letter
Sep 9, 2009	Supplement 13Labeling · Standard review	Approved	Letter
Jun 18, 2008	Supplement 10Manufacturing	Approved	Letter
Feb 29, 2008	Supplement 9Manufacturing	Approved	Letter
Jan 18, 2008	Supplement 8Labeling · Standard review	Approved	Letter
Mar 19, 2007	Supplement 6Labeling · Standard review	Approved	Label Letter
Oct 2, 2006	Supplement 5Labeling · Standard review	Approved	Label Letter
Dec 20, 2004	Supplement 2Labeling · Standard review	Approved	Letter Label
Jun 20, 2003	Original applicationTYPE 2/3 · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21229
Drugs@FDA: Overview at FDA
Company: AstraZeneca Pharmaceuticals LP

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