Omeprazole

Treats active duodenal ulcer. ANDA 91352, held by Zydus Pharms USA Inc. Omeprazole.

As of Nov 15, 2026, ANDA 91352 (Omeprazole), held by Zydus Pharms USA Inc, was first approved by FDA on Nov 19, 2012, with 11 approved supplements and 0 published complete response letters.

First approved: Nov 19, 2012
Supplements approved: 11
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Omeprazole delayed-release capsules are 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 1 year of age and older Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 1 month of age and older Maintenance of healing of EE due to acid-mediated GERD in patients 1 year 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 12 submissions below

Date	Submission	Status	Documents
Nov 19, 2012	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 12 submissions, including labeling and manufacturing supplements


Jul 18, 2023	Supplement 23Labeling · Standard review	Approved	None posted
Mar 4, 2022	Supplement 21Labeling · Standard review	Approved	None posted
Nov 27, 2020	Supplement 20Labeling · Standard review	Approved	None posted
Nov 27, 2020	Supplement 18Labeling · Standard review	Approved	None posted
Jun 7, 2018	Supplement 12Labeling · Standard review	Approved	None posted
May 31, 2018	Supplement 10Labeling · Standard review	Approved	None posted
May 31, 2018	Supplement 9Labeling · Standard review	Approved	None posted
Mar 2, 2015	Supplement 8Labeling · Standard review	Approved	None posted
Dec 13, 2014	Supplement 7Labeling · Standard review	Approved	None posted
Dec 13, 2014	Supplement 5Labeling · Standard review	Approved	None posted
Dec 13, 2014	Supplement 3Labeling · Standard review	Approved	None posted
Nov 19, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 91352
Drugs@FDA: Overview at FDA
Company: Zydus Pharmaceuticals (USA)

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