Omeprazole

Treats active duodenal ulcer. ANDA 203270, held by Aurobindo Pharma. Omeprazole.

As of Nov 15, 2026, ANDA 203270 (Omeprazole), held by Aurobindo Pharma, was first approved by FDA on Aug 19, 2015, with 7 approved supplements and 0 published complete response letters.

First approved: Aug 19, 2015
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Omeprazole 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 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 1.1 Treatment of Active Duodenal Ulcer Omeprazole delayed-release capsules are indicated for short-term treatment of active duodenal ulcer in adults. Most patients heal within four weeks.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Aug 19, 2015	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 8 submissions, including labeling and manufacturing supplements


Jul 18, 2023	Supplement 20Labeling · Standard review	Approved	None posted
Mar 4, 2022	Supplement 19Labeling · Standard review	Approved	None posted
Nov 27, 2020	Supplement 17Labeling · Standard review	Approved	None posted
May 3, 2019	Supplement 10Manufacturing	Approved	None posted
Jun 7, 2018	Supplement 8Labeling · Standard review	Approved	None posted
May 31, 2018	Supplement 4Labeling · Standard review	Approved	None posted
May 31, 2018	Supplement 5Labeling · Standard review	Approved	None posted
Aug 19, 2015	Original application	Approved	None posted

Identifiers

Application: ANDA 203270
Drugs@FDA: Overview at FDA
Company: Aurobindo Pharma

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