Omeprazole

Treats active duodenal ulcer. ANDA 91672, held by Glenmark Pharms Ltd. Omeprazole.

As of Nov 15, 2026, ANDA 91672 (Omeprazole), held by Glenmark Pharms Ltd, was first approved by FDA on Oct 31, 2014, with 8 approved supplements and 0 published complete response letters.

First approved: Oct 31, 2014
Supplements approved: 8
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
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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Oct 31, 2014	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 9 submissions, including labeling and manufacturing supplements


Jul 18, 2023	Supplement 24Labeling · Standard review	Approved	None posted
Mar 4, 2022	Supplement 22Labeling · Standard review	Approved	None posted
Nov 27, 2020	Supplement 17Labeling · Standard review	Approved	None posted
Nov 27, 2020	Supplement 19Labeling · Standard review	Approved	None posted
Jun 7, 2018	Supplement 13Labeling · Standard review	Approved	None posted
May 31, 2018	Supplement 10Labeling · Standard review	Approved	None posted
May 31, 2018	Supplement 12Labeling · Standard review	Approved	None posted
May 21, 2015	Supplement 4Labeling · Standard review	Approved	None posted
Oct 31, 2014	Original application	Approved	None posted

Identifiers

Application: ANDA 91672
Drugs@FDA: Overview at FDA
Company: Glenmark Pharmaceuticals

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