Omeprazole

Treats active duodenal ulcer. ANDA 78490, held by Dr Reddys Labs Ltd. Omeprazole.

As of Nov 15, 2026, ANDA 78490 (Omeprazole), held by Dr Reddys Labs Ltd, was first approved by FDA on Apr 17, 2009, with 11 approved supplements and 0 published complete response letters.

First approved: Apr 17, 2009
Supplements approved: 11
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 12 submissions below

Date	Submission	Status	Documents
Apr 17, 2009	Original application	Approved	None posted

Products

3 strengths and forms


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

All 12 submissions, including labeling and manufacturing supplements


Jul 18, 2023	Supplement 22Labeling · Standard review	Approved	None posted
Mar 4, 2022	Supplement 18Labeling · Standard review	Approved	None posted
Dec 9, 2020	Supplement 16Labeling · Standard review	Approved	None posted
Jun 7, 2018	Supplement 14Labeling · Standard review	Approved	None posted
May 31, 2018	Supplement 12Labeling · Standard review	Approved	None posted
May 31, 2018	Supplement 10Labeling · Standard review	Approved	None posted
Mar 16, 2015	Supplement 6Labeling · Standard review	Approved	None posted
Mar 16, 2015	Supplement 5Labeling · Standard review	Approved	None posted
Mar 16, 2015	Supplement 4Labeling · Standard review	Approved	None posted
Mar 14, 2012	Supplement 2Labeling	Approved	None posted
Mar 14, 2012	Supplement 1Labeling	Approved	None posted
Apr 17, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 78490
Drugs@FDA: Overview at FDA
Company: Dr. Reddy's Laboratories

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