Pantoprazole Sodium

Treats Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD)…. ANDA 77619, held by Dr Reddys Labs Ltd. Pantoprazole Sodium.

As of Nov 15, 2026, ANDA 77619 (Pantoprazole Sodium), held by Dr Reddys Labs Ltd, was first approved by FDA on Jan 19, 2011, with 15 approved supplements and 0 published complete response letters.

First approved: Jan 19, 2011
Supplements approved: 15
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 16 submissions below

Date	Submission	Status	Documents
Jan 19, 2011	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 16 submissions, including labeling and manufacturing supplements


Sep 27, 2023	Supplement 22Labeling · Standard review	Approved	None posted
Aug 15, 2022	Supplement 19Labeling · Standard review	Approved	None posted
Jan 21, 2022	Supplement 17Labeling · Standard review	Approved	None posted
Nov 14, 2019	Supplement 11Labeling · Standard review	Approved	None posted
Nov 14, 2019	Supplement 12Labeling · Standard review	Approved	None posted
Nov 14, 2019	Supplement 13Labeling · Standard review	Approved	None posted
Nov 14, 2019	Supplement 14Labeling · Standard review	Approved	None posted
Nov 14, 2019	Supplement 15Labeling · Standard review	Approved	None posted
Apr 8, 2015	Supplement 10Labeling · Standard review	Approved	None posted
Dec 21, 2014	Supplement 8Labeling · Standard review	Approved	None posted
Dec 21, 2014	Supplement 9Labeling · Standard review	Approved	None posted
May 17, 2013	Supplement 6Labeling · Standard review	Approved	None posted
May 17, 2013	Supplement 7Labeling · Standard review	Approved	None posted
Jan 11, 2012	Supplement 3Labeling	Approved	None posted
Aug 2, 2011	Supplement 2Labeling	Approved	None posted
Jan 19, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 77619
Drugs@FDA: Overview at FDA
Company: Dr. Reddy's Laboratories

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