Prilosec

Treats active duodenal ulcer. NDA 22056, held by Azurity. Omeprazole Magnesium.

As of Nov 14, 2026, NDA 22056 (Prilosec), held by Azurity, was first approved by FDA on Mar 20, 2008, with 21 approved supplements and 0 published complete response letters.

First approved: Mar 20, 2008
Review: Standard
Supplements approved: 21
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

PRILOSEC is a proton pump inhibitor (PPI) indicated for the:

Treatment of active duodenal ulcer in adults
Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults
Treatment of active benign gastric ulcer in adults
Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 1 year of age and older
Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 1 month of age and older
Maintenance of healing of EE due to acid-mediated GERD in patients 1 year of age and older
Pathologic hypersecretory conditions in adults 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 22 submissions below


Feb 3, 2016	Supplement 18Efficacy (new indication or use) · Standard review	Approved	Label Letter Pediatric Medical Review Pediatric Clinical Pharmacology Review
Mar 20, 2008	Original applicationNew dosage form · Standard review	Approved	Summary Review Review Label Letter

Products

2 strengths and forms


PrilosecEQ 2.5MG BASE/PACKET · for suspension, delayed release;oral	Omeprazole Magnesium	RxReference drug
PrilosecEQ 10MG BASE/PACKET · for suspension, delayed release;oral	Omeprazole Magnesium	RxReference drug

All 22 submissions, including labeling and manufacturing supplements


Jul 18, 2023	Supplement 26Labeling · Standard review	Approved	Label Medication Guide Letter
Mar 4, 2022	Supplement 25Labeling · Standard review	Approved	Label Letter Letter
Nov 27, 2020	Supplement 23Labeling · Standard review	Approved	Letter Label
Aug 21, 2018	Supplement 21Labeling · Standard review	Approved	Label Letter
Jun 7, 2018	Supplement 22Labeling · Standard review	Approved	Letter Label
Dec 19, 2016	Supplement 19Labeling · Standard review	Approved	Letter Label
Oct 24, 2016	Supplement 20Labeling · Standard review	Approved	Label Letter
Feb 3, 2016	Supplement 18Efficacy (new indication or use) · Standard review	Approved	Label Letter Pediatric Medical Review Pediatric Clinical Pharmacology Review
Dec 19, 2014	Supplement 17Labeling	Approved	Label Letter
Mar 27, 2014	Supplement 14Labeling · Standard review	Approved	Letter Label
Feb 25, 2014	Supplement 15Labeling	Approved	Label Letter
May 15, 2013	Supplement 13Labeling · Standard review	Approved	Label Letter
Oct 9, 2012	Supplement 11Labeling · Standard review	Approved	Label Letter
Sep 28, 2012	Supplement 12Labeling · Standard review	Approved	Letter Label
Jan 20, 2012	Supplement 10Labeling	Approved	Label Letter
Jun 30, 2011	Supplement 7Labeling	Approved	Letter Label
May 20, 2011	Supplement 9Labeling	Approved	Letter Label
Jan 20, 2011	Supplement 8Labeling	Approved	Letter Label
Sep 3, 2010	Supplement 5Labeling	Approved	Label Letter
Mar 3, 2010	Supplement 3Labeling	Approved	Letter Label
Dec 1, 2008	Supplement 1Labeling · Standard review	Approved	Letter Label
Mar 20, 2008	Original applicationNew dosage form · Standard review	Approved	Summary Review Review Label Letter

Identifiers

Application: NDA 22056
Drugs@FDA: Overview at FDA
Company: Azurity Pharmaceuticals

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