Protonix Iv

NDA 20988, held by Wyeth Pharms. Pantoprazole Sodium.

As of Nov 14, 2026, NDA 20988 (Protonix Iv), held by Wyeth Pharms, was first approved by FDA on Dec 6, 2004, with 50 approved supplements and 0 published complete response letters.

First approved: Dec 6, 2004
Review: Standard
Supplements approved: 50
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

PROTONIX I.V. is indicated for treatment of:

gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults and up to 7 days in pediatric patients 3 months and older.
pathological hypersecretory conditions including Zollinger-Ellison (ZE) Syndrome in adults. Limitations of Use The safety and effectiveness of PROTONIX I.V. for the treatment of upper gastrointestinal bleeding have not been established in adult or pediatric patients.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 52 submissions below


Aug 12, 2024	Supplement 70Efficacy (new indication or use) · Standard review	Approved	Label Letter
Dec 6, 2004	Supplement 27Efficacy (new indication or use)	Approved	Label Letter
Dec 6, 2004	Original application	Approved	None posted
Oct 19, 2001	Supplement 3Efficacy (new indication or use) · Priority review	Approved	Letter Label
Mar 22, 2001	Original applicationNew dosage form · Standard review	Approved	Letter Label Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Protonix IvEQ 40MG BASE/VIAL · injectable;intravenous	Pantoprazole Sodium	RxReference drug

All 52 submissions, including labeling and manufacturing supplements


Aug 12, 2024	Supplement 70Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jul 18, 2023	Supplement 69Labeling · Standard review	Approved	Label Letter
Mar 4, 2022	Supplement 64Labeling · Standard review	Approved	Label Letter
Nov 27, 2020	Supplement 62Labeling · Standard review	Approved	Letter Label
Apr 25, 2019	Supplement 61Labeling · Standard review	Approved	Letter Label
Jun 7, 2018	Supplement 60Labeling · Standard review	Approved	Letter Label
Dec 20, 2017	Supplement 55Labeling · Standard review	Approved	Letter Label
Dec 6, 2017	Supplement 58Labeling · Standard review	Approved	Label Letter
Jul 6, 2017	Supplement 59Labeling · Standard review	Approved	Letter Label
Oct 24, 2016	Supplement 54Labeling · Standard review	Approved	Label Letter
Nov 9, 2015	Supplement 53Manufacturing · Standard review	Approved	None posted
Dec 19, 2014	Supplement 52Labeling	Approved	Label Letter
Nov 5, 2014	Supplement 51Manufacturing · Standard review	Approved	None posted
Sep 26, 2014	Supplement 49Manufacturing · Standard review	Approved	None posted
Sep 26, 2014	Supplement 50Manufacturing · Standard review	Approved	None posted
Mar 4, 2014	Supplement 47Manufacturing · Standard review	Approved	None posted
Dec 12, 2013	Supplement 48Labeling · Standard review	Approved	Label Letter
Sep 28, 2012	Supplement 44Labeling · Standard review	Approved	Letter Label
May 10, 2012	Supplement 45Labeling · Standard review	Approved	Label Letter
Dec 7, 2011	Supplement 42Labeling	Approved	Label Letter
Jun 7, 2011	Supplement 41Labeling	Approved	Label Letter
May 20, 2011	Supplement 43Labeling	Approved	Letter Label
Sep 3, 2010	Supplement 40Labeling	Approved	Label Letter
Dec 20, 2007	Supplement 38Labeling · Standard review	Approved	Letter
Aug 3, 2005	Supplement 32Manufacturing · Standard review	Approved	Letter Label
Aug 2, 2005	Supplement 31Labeling · Standard review	Approved	Letter Label
Dec 6, 2004	Supplement 27Efficacy (new indication or use)	Approved	Label Letter
Dec 6, 2004	Original application	Approved	None posted
Nov 18, 2004	Supplement 28Labeling · Standard review	Approved	Letter
Oct 28, 2004	Supplement 29Manufacturing · Standard review	Approved	Letter
May 5, 2004	Supplement 19Labeling · Standard review	Approved	Label Letter
Apr 2, 2004	Supplement 25Labeling · Standard review	Approved	Letter Label
Apr 2, 2004	Supplement 24Manufacturing · Standard review	Approved	Letter Label
Mar 5, 2004	Supplement 15Labeling · Standard review	Approved	Label Letter
Jan 9, 2004	Supplement 20Labeling · Standard review	Approved	Label Letter
Jan 2, 2004	Supplement 21Labeling · Standard review	Approved	Letter
Nov 18, 2003	Supplement 17Labeling · Standard review	Approved	Label Letter
Oct 24, 2003	Supplement 16Labeling · Standard review	Approved	Letter
Feb 21, 2003	Supplement 7Labeling · Standard review	Approved	Letter
Dec 4, 2002	Supplement 14Manufacturing · Standard review	Approved	None posted
Dec 3, 2002	Supplement 13Manufacturing · Standard review	Approved	None posted
Oct 28, 2002	Supplement 12Labeling · Standard review	Approved	Letter
Jul 2, 2002	Supplement 9Manufacturing · Standard review	Approved	None posted
May 14, 2002	Supplement 11Manufacturing · Standard review	Approved	None posted
Jan 18, 2002	Supplement 10Manufacturing · Standard review	Approved	None posted
Jan 15, 2002	Supplement 1Manufacturing · Standard review	Approved	None posted
Nov 28, 2001	Supplement 8Manufacturing · Standard review	Approved	None posted
Oct 19, 2001	Supplement 3Efficacy (new indication or use) · Priority review	Approved	Letter Label
Sep 27, 2001	Supplement 2Manufacturing · Standard review	Approved	None posted
Jul 3, 2001	Supplement 4Labeling · Standard review	Approved	None posted
Jun 8, 2001	Supplement 6Manufacturing · Standard review	Approved	None posted
Mar 22, 2001	Original applicationNew dosage form · Standard review	Approved	Letter Label Review

Show all 52

Identifiers

Application: NDA 20988
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