Omeprazole

Treats active duodenal ulcer. ANDA 75410, held by Lannett Co Inc. Omeprazole.

As of Nov 15, 2026, ANDA 75410 (Omeprazole), held by Lannett Co Inc, was first approved by FDA on Nov 1, 2002, with 27 approved supplements and 0 published complete response letters.

First approved: Nov 1, 2002
Supplements approved: 27
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Omeprazole Delayed-Release Capsules 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 1 year of age and older Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 1 year 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 29 submissions below

Date	Submission	Status	Documents
Nov 1, 2002	Original application	Approved	Review Letter

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 29 submissions, including labeling and manufacturing supplements


Jul 18, 2023	Supplement 68Labeling · Standard review	Approved	None posted
Mar 4, 2022	Supplement 66Labeling · Standard review	Approved	None posted
Dec 1, 2020	Supplement 64Labeling · Standard review	Approved	None posted
Nov 27, 2020	Supplement 62Labeling · Standard review	Approved	None posted
Jun 7, 2018	Supplement 57Labeling · Standard review	Approved	None posted
May 31, 2018	Supplement 55Labeling · Standard review	Approved	None posted
Feb 25, 2016	Supplement 51Labeling · Standard review	Approved	None posted
Feb 27, 2015	Supplement 49Labeling · Standard review	Approved	None posted
Feb 27, 2015	Supplement 48Labeling · Standard review	Approved	None posted
Feb 27, 2015	Supplement 45Labeling · Standard review	Approved	None posted
Feb 27, 2015	Supplement 42Labeling · Standard review	Approved	None posted
Jan 30, 2015	Supplement 43Manufacturing	Approved	None posted
Nov 2, 2012	Supplement 39Labeling	Approved	None posted
Feb 16, 2012	Supplement 38Labeling	Approved	None posted
Feb 16, 2012	Supplement 37Labeling	Approved	None posted
Feb 16, 2012	Supplement 36Labeling	Approved	None posted
Feb 16, 2012	Supplement 34Labeling	Approved	None posted
Nov 17, 2010	Supplement 32Labeling	Approved	None posted
Nov 17, 2010	Supplement 31Labeling	Approved	None posted
Jan 23, 2009	Supplement 16Labeling	Approved	None posted
Mar 21, 2007	Supplement 27Labeling	Approved	None posted
Mar 21, 2007	Supplement 25Labeling	Approved	None posted
Sep 26, 2006	Supplement 24Labeling	Approved	None posted
Mar 24, 2005	Supplement 15Manufacturing	Tentative approval	None posted
Jul 14, 2004	Supplement 20Labeling	Approved	None posted
Apr 29, 2004	Supplement 9Labeling	Approved	None posted
Feb 13, 2004	Supplement 13Labeling	Approved	None posted
Aug 6, 2003	Supplement 8Labeling	Approved	None posted
Nov 1, 2002	Original application	Approved	Review Letter

Identifiers

Application: ANDA 75410
Drugs@FDA: Overview at FDA
Company: Lannett Company

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