Protonix

Treats Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD). NDA 20987, held by Wyeth Pharms. Pantoprazole Sodium.

As of Nov 13, 2026, NDA 20987 (Protonix), held by Wyeth Pharms, was first approved by FDA on Feb 2, 2000, with 43 approved supplements and 0 published complete response letters.

First approved: Feb 2, 2000
Review: Standard
Supplements approved: 43
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 44 submissions below

Date	Submission	Status	Documents
Nov 12, 2009	Supplement 36Efficacy (new indication or use) · Standard review	Approved	Letter Label
Apr 19, 2002	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Letter Review Label
Jun 12, 2001	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Label Letter
Feb 2, 2000	Original applicationNew molecular entity · Standard review	Approved	Letter Label Review

Products

2 strengths and forms

Product	Active ingredient	Marketing
ProtonixEQ 40MG BASE · tablet, delayed release;oral	Pantoprazole Sodium	DiscontinuedReference drug
ProtonixEQ 20MG BASE · tablet, delayed release;oral	Pantoprazole Sodium	DiscontinuedReference drug

All 44 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jul 18, 2023	Supplement 60Labeling · Standard review	Approved	Label Medication Guide Letter
Mar 4, 2022	Supplement 58Labeling · Standard review	Approved	Label Letter
Nov 27, 2020	Supplement 56Labeling · Standard review	Approved	Letter Label
Apr 25, 2019	Supplement 55Labeling · Standard review	Approved	Letter Label
Jun 7, 2018	Supplement 54Labeling · Standard review	Approved	Letter Label
Dec 20, 2017	Supplement 51Labeling · Standard review	Approved	Letter Label
Dec 6, 2017	Supplement 52Labeling · Standard review	Approved	Label Letter
Jul 6, 2017	Supplement 53Labeling · Standard review	Approved	Label Letter
Oct 24, 2016	Supplement 50Labeling · Standard review	Approved	Label Letter
Dec 19, 2014	Supplement 49Labeling	Approved	Label Letter
Dec 10, 2013	Supplement 48Labeling · Standard review	Approved	Letter Label
Jan 25, 2013	Supplement 46Manufacturing · Standard review	Approved	None posted
Oct 9, 2012	Supplement 43Labeling · Standard review	Approved	Label Letter
May 11, 2012	Supplement 45Labeling · Standard review	Approved	Label
Oct 31, 2011	Supplement 39Labeling	Approved	Label Letter
May 20, 2011	Supplement 41Labeling	Approved	Letter Label
Sep 3, 2010	Supplement 38Labeling	Approved	Label Letter
Nov 12, 2009	Supplement 37Labeling · Standard review	Approved	Letter Label
Nov 12, 2009	Supplement 36Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 20, 2007	Supplement 35Labeling · Standard review	Approved	Letter
Jul 25, 2006	Supplement 32Labeling · Standard review	Approved	Letter
Nov 18, 2004	Supplement 26Labeling · Standard review	Approved	Letter
May 5, 2004	Supplement 20Labeling · Standard review	Approved	Letter Label
Mar 12, 2004	Supplement 23Labeling · Standard review	Approved	Label Letter
Mar 5, 2004	Supplement 17Labeling · Standard review	Approved	Label Letter
Jan 9, 2004	Supplement 22Labeling · Standard review	Approved	Label Letter
Dec 30, 2003	Supplement 21Labeling · Standard review	Approved	Letter
Dec 6, 2002	Supplement 14Manufacturing · Standard review	Approved	None posted
Dec 4, 2002	Supplement 16Manufacturing · Standard review	Approved	None posted
Dec 3, 2002	Supplement 15Manufacturing · Standard review	Approved	None posted
Oct 28, 2002	Supplement 13Labeling · Standard review	Approved	Letter
Sep 5, 2002	Supplement 11Manufacturing · Standard review	Approved	None posted
Jul 22, 2002	Supplement 12Manufacturing · Standard review	Approved	None posted
Jul 2, 2002	Supplement 9Manufacturing · Standard review	Approved	None posted
Jun 12, 2002	Supplement 6Manufacturing · Standard review	Approved	None posted
May 14, 2002	Supplement 10Manufacturing · Standard review	Approved	None posted
Apr 19, 2002	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Letter Review Label
Mar 12, 2002	Supplement 8Manufacturing · Standard review	Approved	None posted
Jul 20, 2001	Supplement 5Labeling · Standard review	Approved	Label
Jun 12, 2001	Supplement 2Manufacturing · Standard review	Approved	Letter
Jun 12, 2001	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Label Letter
May 21, 2001	Supplement 4Labeling · Standard review	Approved	None posted
Oct 19, 2000	Supplement 3Manufacturing · Standard review	Approved	None posted
Feb 2, 2000	Original applicationNew molecular entity · Standard review	Approved	Letter Label Review

Identifiers

Application: NDA 20987
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