Omeprazole

Treats active duodenal ulcer. ANDA 75757, held by Sandoz. Omeprazole.

As of Nov 15, 2026, ANDA 75757 (Omeprazole), held by Sandoz, was first approved by FDA on Jan 28, 2003, with 24 approved supplements and 0 published complete response letters.

First approved: Jan 28, 2003
Supplements approved: 24
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 ( Error! Hyperlink reference not valid. )
Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older ( Error! Hyperlink reference not valid.

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
Jan 28, 2003	Original application	Approved	None posted

Products

2 strengths and forms


Omeprazole10MG · capsule, delayed rel pellets;oral	Omeprazole	Rx
Omeprazole20MG · capsule, delayed rel pellets;oral	Omeprazole	Rx

All 25 submissions, including labeling and manufacturing supplements


Oct 11, 2023	Supplement 56Labeling · Standard review	Approved	None posted
Mar 4, 2022	Supplement 54Labeling · Standard review	Approved	None posted
Nov 27, 2020	Supplement 52Labeling · Standard review	Approved	None posted
Jun 7, 2018	Supplement 49Labeling · Standard review	Approved	None posted
Sep 28, 2017	Supplement 46Labeling · Standard review	Approved	None posted
Apr 14, 2015	Supplement 43Labeling · Standard review	Approved	None posted
Apr 14, 2015	Supplement 42Labeling · Standard review	Approved	None posted
Apr 14, 2015	Supplement 39Labeling · Standard review	Approved	None posted
Apr 14, 2015	Supplement 38Labeling · Standard review	Approved	None posted
Oct 31, 2014	Supplement 32Manufacturing	Approved	None posted
Dec 31, 2013	Supplement 36Labeling · Standard review	Approved	None posted
Dec 31, 2013	Supplement 33Labeling · Standard review	Approved	None posted
Sep 19, 2012	Supplement 31Labeling · Standard review	Approved	None posted
Feb 13, 2012	Supplement 29Labeling	Approved	None posted
Feb 13, 2012	Supplement 28Labeling	Approved	None posted
Feb 13, 2012	Supplement 27Labeling	Approved	None posted
Jan 7, 2011	Supplement 25Labeling	Approved	None posted
Feb 26, 2010	Supplement 20Labeling	Approved	None posted
Nov 16, 2007	Supplement 16Labeling	Approved	None posted
Mar 21, 2007	Supplement 11Labeling	Approved	None posted
Aug 24, 2006	Supplement 13Labeling	Approved	None posted
Sep 29, 2005	Supplement 7Labeling	Approved	None posted
Jul 12, 2005	Supplement 8Labeling	Approved	None posted
May 19, 2004	Supplement 4Labeling	Approved	None posted
Jan 28, 2003	Original application	Approved	None posted

Identifiers

Application: ANDA 75757
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