Pantoprazole Sodium

ANDA 90074, held by Torrent Pharms. Pantoprazole Sodium.

As of Nov 15, 2026, ANDA 90074 (Pantoprazole Sodium), held by Torrent Pharms, was first approved by FDA on Jan 19, 2011, with 13 approved supplements and 0 published complete response letters.

First approved: Jan 19, 2011
Supplements approved: 13
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Pantoprazole is a proton pump inhibitor 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 Syndrome Pantoprazole sodium delayed-release tablets are indicated for: 1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD) Pantoprazole sodium delayed-release tablets are indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 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 14 submissions, including labeling and manufacturing supplements


Sep 27, 2023	Supplement 28Labeling · Standard review	Approved	None posted
Aug 11, 2022	Supplement 26Labeling · Standard review	Approved	None posted
Jan 7, 2022	Supplement 24Labeling · Standard review	Approved	None posted
Nov 14, 2019	Supplement 16Labeling · Standard review	Approved	None posted
Nov 14, 2019	Supplement 18Labeling · Standard review	Approved	None posted
Nov 14, 2019	Supplement 19Labeling · Standard review	Approved	None posted
Nov 14, 2019	Supplement 22Labeling · Standard review	Approved	None posted
Apr 9, 2015	Supplement 12Labeling · Standard review	Approved	None posted
Feb 25, 2015	Supplement 10Labeling · Standard review	Approved	None posted
Dec 5, 2014	Supplement 11Labeling · Standard review	Approved	None posted
May 30, 2013	Supplement 6Labeling · Standard review	Approved	None posted
May 30, 2013	Supplement 8Labeling · Standard review	Approved	None posted
Jan 17, 2012	Supplement 4Labeling	Approved	None posted
Jan 19, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 90074
Drugs@FDA: Overview at FDA
Company: Torrent 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