Omeprazole

Treats active duodenal ulcer. ANDA 76048, held by Apotex. Omeprazole.

As of Nov 15, 2026, ANDA 76048 (Omeprazole), held by Apotex, was first approved by FDA on Oct 22, 2007, with 14 approved supplements and 0 published complete response letters.

First approved: Oct 22, 2007
Supplements approved: 14
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Omeprazole is a proton pump inhibitor indicated for:

Treatment in adults of duodenal ulcer and gastric ulcer
Treatment in adults and children of gastroesophageal reflux disease (GERD) and maintenance of healing of erosive esophagitis The safety and effectiveness of omeprazole in pediatric patients <1 year of age have not been established. 1.1 Duodenal Ulcer (adults) Omeprazole delayed-release capsules, USP are indicated for short-term treatment of active duodenal ulcer in adults. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Oct 22, 2007	Original application	Approved	None posted

Products

3 strengths and forms


Omeprazole10MG · capsule, delayed rel pellets;oral	Omeprazole	Rx
Omeprazole20MG · capsule, delayed rel pellets;oral	Omeprazole	Rx
Omeprazole40MG · capsule, delayed rel pellets;oral	Omeprazole	Rx

All 15 submissions, including labeling and manufacturing supplements


Jul 18, 2023	Supplement 29Labeling · Standard review	Approved	None posted
Mar 4, 2022	Supplement 28Labeling · Standard review	Approved	None posted
Feb 28, 2022	Supplement 26Labeling · Standard review	Approved	None posted
Nov 27, 2020	Supplement 23Labeling · Standard review	Approved	None posted
Jun 7, 2018	Supplement 21Labeling · Standard review	Approved	None posted
May 31, 2018	Supplement 20Labeling · Standard review	Approved	None posted
Mar 20, 2015	Supplement 19Labeling · Standard review	Approved	None posted
Dec 12, 2014	Supplement 16Labeling · Standard review	Approved	None posted
Dec 12, 2014	Supplement 17Labeling · Standard review	Approved	None posted
Jun 30, 2013	Supplement 11Labeling · Standard review	Approved	None posted
Jun 30, 2013	Supplement 12Labeling · Standard review	Approved	None posted
Mar 23, 2012	Supplement 7Labeling	Approved	None posted
Mar 23, 2012	Supplement 9Labeling	Approved	None posted
Jan 21, 2009	Supplement 3Labeling	Approved	None posted
Oct 22, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 76048
Drugs@FDA: Overview at FDA
Company: Apotex

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