Omeprazole

Treats active duodenal ulcer. ANDA 76515, held by Sandoz. Omeprazole.

As of Nov 15, 2026, ANDA 76515 (Omeprazole), held by Sandoz, was first approved by FDA on Jan 21, 2009, with 18 approved supplements and 0 published complete response letters.

First approved: Jan 21, 2009
Supplements approved: 18
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Omeprazole delayed-release capsules are 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 2 years of age and older
Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 2 years of age and older
Maintenance of healing of EE due to acid-mediated GERD in patients 2 years 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 19 submissions below

Date	Submission	Status	Documents
Jan 21, 2009	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Omeprazole40MG · capsule, delayed rel pellets;oral	Omeprazole	Rx

All 19 submissions, including labeling and manufacturing supplements


Oct 11, 2023	Supplement 37Labeling · Standard review	Approved	None posted
Mar 4, 2022	Supplement 35Labeling · Standard review	Approved	None posted
Nov 27, 2020	Supplement 32Labeling · Standard review	Approved	None posted
Nov 27, 2020	Supplement 33Labeling · Standard review	Approved	None posted
Jun 7, 2018	Supplement 29Labeling · Standard review	Approved	None posted
Sep 28, 2017	Supplement 27Labeling · Standard review	Approved	None posted
Mar 30, 2016	Supplement 20Labeling · Standard review	Approved	None posted
Mar 30, 2016	Supplement 21Labeling · Standard review	Approved	None posted
Mar 30, 2016	Supplement 24Labeling · Standard review	Approved	None posted
Dec 19, 2013	Supplement 16Labeling · Standard review	Approved	None posted
Dec 19, 2013	Supplement 18Labeling · Standard review	Approved	None posted
Sep 20, 2012	Supplement 14Labeling · Standard review	Approved	None posted
Feb 14, 2012	Supplement 10Labeling	Approved	None posted
Feb 14, 2012	Supplement 11Labeling	Approved	None posted
Feb 14, 2012	Supplement 12Labeling	Approved	None posted
Jan 4, 2011	Supplement 9Labeling	Approved	None posted
Nov 23, 2010	Supplement 8Labeling	Approved	None posted
Sep 7, 2010	Supplement 4Manufacturing	Approved	None posted
Jan 21, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 76515
Drugs@FDA: Overview at FDA
Company: Sandoz

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