Omeprazole

NDA 22032, held by Dexcel Pharma. Omeprazole.

As of Nov 14, 2026, NDA 22032 (Omeprazole), held by Dexcel Pharma, was first approved by FDA on Dec 4, 2007, with 26 approved supplements and 0 published complete response letters.

First approved: Dec 4, 2007
Review: Standard
Supplements approved: 26
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Use

treats frequent heartburn (occurs 2 or more days a week)
not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 27 submissions below

Date	Submission	Status	Documents
Dec 4, 2007	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Summary Review Letter Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Omeprazole20MG · tablet, delayed release;oral	Omeprazole	OTCReference drug

All 27 submissions, including labeling and manufacturing supplements


Oct 3, 2025	Supplement 70Manufacturing	Approved	Label Letter
Nov 8, 2024	Supplement 65Manufacturing	Approved	Letter Label
Sep 30, 2022	Supplement 57Labeling · Standard review	Approved	Label Letter
Oct 21, 2021	Supplement 52Manufacturing	Approved	Label Letter
Jul 7, 2021	Supplement 46Labeling · Standard review	Approved	Letter
Apr 8, 2019	Supplement 41Labeling · Standard review	Approved	Label Letter
Nov 13, 2017	Supplement 38Labeling · Standard review	Approved	Letter Label
Oct 30, 2017	Supplement 37Labeling · Standard review	Approved	Label Letter
Dec 1, 2016	Supplement 34Manufacturing · Standard review	Approved	None posted
Feb 10, 2016	Supplement 32Labeling · Standard review	Approved	Letter Label
Feb 8, 2016	Supplement 31Manufacturing · Standard review	Approved	None posted
Jan 5, 2016	Supplement 25Manufacturing · Standard review	Approved	None posted
Aug 7, 2015	Supplement 26Manufacturing · Standard review	Approved	None posted
Jun 11, 2015	Supplement 29Labeling · Standard review	Approved	Label Letter
Jun 1, 2015	Supplement 28Manufacturing · Standard review	Approved	None posted
Mar 30, 2015	Supplement 27Manufacturing · Standard review	Approved	None posted
Mar 6, 2015	Supplement 24Manufacturing · Standard review	Approved	Review Label Letter
Sep 13, 2013	Supplement 22Manufacturing · Standard review	Approved	None posted
Aug 16, 2013	Supplement 21Labeling · Standard review	Approved	Label Letter
Oct 29, 2012	Supplement 20Labeling · Standard review	Approved	Label Letter
Sep 10, 2012	Supplement 19Labeling · Standard review	Approved	Letter
Apr 9, 2012	Supplement 16Labeling · Standard review	Approved	Letter
Jun 27, 2011	Supplement 12Labeling	Approved	Letter
Jul 16, 2010	Supplement 8Labeling · Standard review	Approved	Letter
Sep 21, 2009	Supplement 4Manufacturing	Approved	None posted
Apr 2, 2009	Supplement 3Labeling · Standard review	Approved	Label Letter Letter
Dec 4, 2007	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Summary Review Letter Letter

Identifiers

Application: NDA 22032
Drugs@FDA: Overview at FDA
Company: Dexcel Pharma

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