Pantoprazole Sodium

Treats Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD). ANDA 205119, held by Amneal Pharms. Pantoprazole Sodium.

As of Nov 15, 2026, ANDA 205119 (Pantoprazole Sodium), held by Amneal Pharms, was first approved by FDA on Jan 26, 2016, with 9 approved supplements and 0 published complete response letters.

First approved: Jan 26, 2016
Review: Standard
Supplements approved: 9
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Pantoprazole sodium delayed-release tablets are indicated for: Pantoprazole sodium 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 10 submissions below

Date	Submission	Status	Documents
Jan 26, 2016	Original application	Approved	None posted

Products

2 strengths and forms


Pantoprazole SodiumEQ 20MG BASE · tablet, delayed release;oral	Pantoprazole Sodium	Rx
Pantoprazole SodiumEQ 40MG BASE · tablet, delayed release;oral	Pantoprazole Sodium	Rx

All 10 submissions, including labeling and manufacturing supplements


Nov 27, 2024	Supplement 19Labeling · Standard review	Approved	None posted
Nov 27, 2024	Supplement 16Labeling · Standard review	Approved	None posted
Nov 27, 2024	Supplement 15Labeling · Standard review	Approved	None posted
Nov 27, 2024	Supplement 13Labeling · Standard review	Approved	None posted
Sep 16, 2019	Supplement 7Labeling · Standard review	Approved	None posted
Sep 16, 2019	Supplement 5Labeling · Standard review	Approved	None posted
Sep 16, 2019	Supplement 4Labeling · Standard review	Approved	None posted
Sep 16, 2019	Supplement 3Labeling · Standard review	Approved	None posted
Sep 16, 2019	Supplement 2Labeling · Standard review	Approved	None posted
Jan 26, 2016	Original application	Approved	None posted

Identifiers

Application: ANDA 205119
Drugs@FDA: Overview at FDA
Company: Amneal 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