Omeprazole

Treats active duodenal ulcer. ANDA 204012, held by Hetero Labs Ltd Iii. Omeprazole.

As of Nov 15, 2026, ANDA 204012 (Omeprazole), held by Hetero Labs Ltd Iii, was first approved by FDA on Sep 26, 2019, with 3 approved supplements and 0 published complete response letters.

First approved: Sep 26, 2019
Supplements approved: 3
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 4 submissions below

Date	Submission	Status	Documents
Sep 26, 2019	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 4 submissions, including labeling and manufacturing supplements


Jul 18, 2023	Supplement 3Labeling · Standard review	Approved	None posted
Mar 4, 2022	Supplement 2Labeling · Standard review	Approved	None posted
Nov 27, 2020	Supplement 1Labeling · Standard review	Approved	None posted
Sep 26, 2019	Original application	Approved	None posted

Identifiers

Application: ANDA 204012
Drugs@FDA: Overview at FDA
Company: Hetero Labs Ltd Iii

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