Zegerid

NDA 21849, held by Salix. Omeprazole; Sodium Bicarbonate.

As of Nov 14, 2026, NDA 21849 (Zegerid), held by Salix, was first approved by FDA on Feb 27, 2006, with 17 approved supplements and 0 published complete response letters.

First approved: Feb 27, 2006
Review: Standard
Supplements approved: 17
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Feb 27, 2006	Original applicationNew combination · Standard review	Approved	Review Letter Label

Products

2 strengths and forms


Zegerid20MG;1.1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Omeprazole; Sodium Bicarbonate	DiscontinuedReference drug
Zegerid40MG;1.1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Omeprazole; Sodium Bicarbonate	DiscontinuedReference drug

All 18 submissions, including labeling and manufacturing supplements


Jul 18, 2023	Supplement 20Labeling · Standard review	Approved	Label Medication Guide Letter
Mar 4, 2022	Supplement 19Labeling · Standard review	Approved	Label Letter
Mar 16, 2021	Supplement 17Manufacturing	Approved	Letter Label
Nov 27, 2020	Supplement 16Labeling · Standard review	Approved	Letter Label
Sep 24, 2019	Supplement 15Labeling · Standard review	Approved	Label Letter
Jun 7, 2018	Supplement 14Labeling · Standard review	Approved	Letter Label
Oct 24, 2016	Supplement 12Labeling · Standard review	Approved	Label Letter
Jun 1, 2016	Supplement 11Manufacturing · Standard review	Approved	None posted
Dec 19, 2014	Supplement 10Labeling	Approved	Label Letter
Feb 25, 2014	Supplement 9Labeling	Approved	Letter Label
Nov 9, 2012	Supplement 7Labeling · Standard review	Approved	Label Letter
Apr 19, 2012	Supplement 8Labeling · Standard review	Approved	Letter Label
Dec 7, 2011	Supplement 6Labeling	Approved	Label Letter
May 20, 2011	Supplement 5Labeling	Approved	Label Letter
Sep 3, 2010	Supplement 4Labeling	Approved	Label Letter
Jan 20, 2010	Supplement 3Labeling · Standard review	Approved	Letter
Dec 21, 2007	Supplement 2Manufacturing	Approved	Review Letter Label
Feb 27, 2006	Original applicationNew combination · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21849
Drugs@FDA: Overview at FDA
Company: Salix 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