Protonix

Treats Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD). NDA 22020, held by Wyeth Pharms. Pantoprazole Sodium.

As of Nov 13, 2026, NDA 22020 (Protonix), held by Wyeth Pharms, was first approved by FDA on Nov 14, 2007, with 17 approved supplements and 0 published complete response letters.

First approved: Nov 14, 2007
Review: Standard
Supplements approved: 17
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

PROTONIX For Delayed-Release Oral Suspension and PROTONIX Delayed-Release Tablets are indicated for: PROTONIX is a proton pump inhibitor (PPI) indicated for the following:

Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD)
Maintenance of Healing of Erosive Esophagitis
Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) Syndrome 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

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

Date	Submission	Status	Documents
Nov 14, 2007	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
ProtonixEQ 40MG BASE · for suspension, delayed release;oral	Pantoprazole Sodium	DiscontinuedReference drug

All 18 submissions, including labeling and manufacturing supplements


Jul 18, 2023	Supplement 23Labeling · Standard review	Approved	Label Medication Guide Letter
Mar 4, 2022	Supplement 21Labeling · Standard review	Approved	Label Letter
Nov 27, 2020	Supplement 18Labeling · Standard review	Approved	Letter Label
Apr 25, 2019	Supplement 17Labeling · Standard review	Approved	Letter Label
Jun 7, 2018	Supplement 16Labeling · Standard review	Approved	Letter Label
Dec 20, 2017	Supplement 13Labeling · Standard review	Approved	Letter Label
Dec 6, 2017	Supplement 14Labeling · Standard review	Approved	Label Letter
Jul 6, 2017	Supplement 15Labeling · Standard review	Approved	Label Letter
Oct 24, 2016	Supplement 12Labeling · Standard review	Approved	Label Letter
Dec 19, 2014	Supplement 11Labeling	Approved	Label Letter
Dec 10, 2013	Supplement 10Labeling · Standard review	Approved	Letter Label
Oct 9, 2012	Supplement 6Labeling · Standard review	Approved	Label Letter
May 11, 2012	Supplement 7Labeling · Standard review	Approved	Label
Oct 31, 2011	Supplement 4Labeling	Approved	Label Letter
May 20, 2011	Supplement 5Labeling	Approved	Letter Label
Sep 3, 2010	Supplement 3Labeling	Approved	Label Letter
Nov 12, 2009	Supplement 2Labeling · Standard review	Approved	Letter Label
Nov 14, 2007	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 22020
Drugs@FDA: Overview at FDA
Company: Wyeth 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